Medicare and Medicaid Programs; CY 2025 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Medicare Prescription Drug Inflation Rebate Program; and Medicare Overpayments, 61596-62648 [2024-14828]
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61596
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
42 CFR Parts 401, 405, 410, 411, 414,
423, 424, 425, 427, 428, and 491
[CMS–1807–P]
RIN 0938–AV33
Medicare and Medicaid Programs; CY
2025 Payment Policies Under the
Physician Fee Schedule and Other
Changes to Part B Payment and
Coverage Policies; Medicare Shared
Savings Program Requirements;
Medicare Prescription Drug Inflation
Rebate Program; and Medicare
Overpayments
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; codification of,
and proposing policies for, the Medicare
Prescription Drug Inflation Rebate
Program under the Inflation Reduction
Act of 2022; updates to the Medicare
Diabetes Prevention Program expanded
model; payment for dental services
inextricably linked to specific covered
medical services; updates to drugs and
biological products paid under Part B
including immunosuppressive drugs
and clotting factors; 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 policies
for Rural Health Clinics and Federally
Qualified Health Centers; electronic
prescribing for controlled substances for
a covered Part D drug under a
prescription drug plan or a Medicare
Advantage Prescription Drug (MA–PD)
plan under the Substance Use-Disorder
Prevention that Promotes Opioid
Recovery and Treatment for Patients
and Communities Act (SUPPORT Act);
update to the Ambulance Fee Schedule
regulations; codification of the Inflation
Reduction Act and Consolidated
Appropriations Act, 2023 provisions;
updates to Clinical Laboratory Fee
Schedule regulations; updates to the
diabetes payment structure and PHE
flexibilities; expansion of colorectal
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SUMMARY:
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cancer screening and Hepatitis B
vaccine coverage and payment;
establishing payment for drugs covered
as additional preventive services;
Medicare Parts A and B Overpayment
Provisions of the Affordable Care Act.
DATES: To be assured consideration,
comments must be received at one of
the addresses provided below, no later
than 5 p.m. on September 9, 2024.
ADDRESSES: In commenting, please refer
to file code CMS–1807–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–1807–
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–1807–
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,
Morgan Kitzmiller, (410) 786–1623, or
MedicarePhysicianFeeSchedule@
cms.hhs.gov, for issues related to
practice expense, work RVUs,
conversion factor, and PFS specialtyspecific impacts.
Kris Corwin, (410) 786–8864, or
MedicarePhysicianFeeSchedule@
cms.hhs.gov, for issues related to
strategies for updates to practice
expense data collection and
methodology.
Hannah Ahn, (814) 769–0143, or
MedicarePhysicianFeeSchedule@
cms.hhs.gov, for issues related to
potentially misvalued services under
the PFS.
Kris Corwin, (410) 786–8864, Patrick
Sartini, (410) 786–9252, Mikayla
Murphy, (667) 414–0093, or
MedicarePhysicianFeeSchedule@
cms.hhs.gov, for issues related to direct
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supervision using two-way audio/video
communication technology, telehealth,
and other services involving
communications technology.
Tamika Brock, (312) 886–7904, or
MedicarePhysicianFeeSchedule@
cms.hhs.gov, for issues related to
teaching physician billing for services
involving residents in teaching settings.
Sarah Leipnik, (410) 786–3933,
Mikayla Murphy, (667) 414–0093,
Regina Walker-Wren, (410) 786–9160, or
MedicarePhysicianFeeSchedule@
cms.hhs.gov, for issues related to
payment for caregiver training services
and addressing health-related social
needs (community health integration,
principal illness navigation, and social
determinants of health risk assessment).
Erick Carrera, (410) 786–8949, or
MedicarePhysicianFeeSchedule@
cms.hhs.gov, for issues related to office/
outpatient evaluation and management
visit inherent complexity add-one.
Sarah Irie, (410) 786–1348, Emily
Parris (667) 414–0418, or
MedicarePhysicianFeeSchedule@
cms.hhs.gov, for issues related to
payment for advanced primary care
management service.
Sarah Leipnik, (410) 786–3933, or
MedicarePhysicianFeeSchedule@
cms.hhs.gov, for issues related to global
surgery payment accuracy.
Pamela West, (410) 786–2302, for
issues related to supervision of
outpatient therapy services in private
practices, certification of therapy plans
of care, and KX modifier threshold.
Lindsey Baldwin, (410) 786–1694,
Regina Walker-Wren, (410) 786–9160,
Erick Carrera, (410) 786–8949, Mikayla
Murphy, (667) 414–0093, or
MedicarePhysicianFeeSchedule@
cms.hhs.gov, for issues related to
advancing access to behavioral health
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.
Zehra Hussain, (214) 767–4463, or
MedicarePhysicianFeeSchedule@
cms.hhs.gov, for issues related to
payment of skin substitutes.
Laura Kennedy, (410) 786–3377,
Adam Brooks, (202) 205–0671, Rachel
Radzyner, (410) 786–8215, Rebecca Ray,
(667) 414–0879, and Jae Ryu, (667) 414–
0765 for issues related to Drugs and
Biological Products Paid Under
Medicare Part B.
MedicarePhysicianFeeSchedule@
cms.hhs.gov, for issues related to
complex drug administration.
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Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
Glenn McGuirk, (410) 786–5723, 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.
Heidi Oumarou, (410) 786–7942, for
issues related to the FQHC market
basket.
Michele Franklin, (410) 786–9226, or
RHC@cms.hhs.gov, for issues related to
RHC payments.
Kianna Banks (410) 786–3498 and
Cara Meyer (667) 290–9856, for issues
related to RHCs and FQHCs and
Conditions for Certification or Coverage.
Colleen Barbero (667) 290–8794, for
issues related to Medicare Diabetes
Prevention Program.
Ariana Pitcher, (667) 290–8840, or
OTP_Medicare@cms.hhs.gov, for issues
related to Medicare coverage of opioid
use 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
SharedSavingsProgram@cms.hhs.gov,
for issues related to Shared Savings
Program beneficiary assignment and
benchmarking methodology.
Richard (Chase) Kendall, (410) 786–
1000, or SharedSavingsProgram@
cms.hhs.gov, for issues related to
reopening ACO payment
determinations, and mitigating the
impact of significant, anomalous, and
highly suspect billing activity on Shared
Savings Program financial calculations.
Lucy Bertocci, (410) 786–3776, or
SharedSavingsProgram@cms.hhs.gov,
for issues related to Shared Savings
Program prepaid shared savings,
advance investment payments,
beneficiary notice and eligibility
requirements.
Rachel Radzyner, (410) 786–8215, for
issues related to payment for
preventative services, including
preventive vaccine administration and
drugs covered as additional preventive
services.
Elisabeth Daniel, (667) 290–8793, for
issues related to the Medicare
Prescription Drug Inflation Rebate
Program.
Genevieve Kehoe,
Ambulatoryspecialtycare@cms.hhs.gov,
or 1–844–711–2664 (Option 4) for issues
related to the Request for Information:
Building upon the MIPS Value
Pathways (MVPs) Framework to
Improve Ambulatory Specialty Care.
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Kimberly Long, (410) 786–5702, for
issues related to expanding colorectal
cancer screening.
Rachel Katonak, (410) 786–8564, for
issues related to expanding Hepatitis B
vaccine coverage.
Mei Zhang, (410) 786–7837, 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).
Katie Parker, (410) 786–0537, for
issues related to Parts A and B
overpayment provisions of the
Affordable Care Act.
Amy Gruber, (410) 786–1542, for
issues related to low titer O+ whole
blood transfusion therapy during
ground ambulance transport.
Renee O’Neill, (410) 786–8821, or
Sophia Sugumar, (410) 786–1648, for
inquiries related to Merit-based
Incentive Payment System (MIPS) track
of the Quality Payment Program.
Danielle Drayer, (516) 965–6630, for
inquiries related to Alternative Payment
Models (APMs).
SUPPLEMENTARY INFORMATION:
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 2025 PFS
proposed rule, refer to item CMS–1807–
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.
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I. Executive Summary
A. Purpose
This major annual rule proposes to
revise payment policies under the
Medicare PFS and makes other policy
changes, including proposals to
implement certain provisions of the
Further Continuing Appropriations and
Other Extensions Act of 2024 (Pub. L.
118–22, November 16, 2023),
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.
This rulemaking also proposes to
codify policies previously established in
guidance for the Medicare Prescription
Drug Inflation Rebate Program at new
parts 427 and 428, including
clarifications to certain existing policies,
consistent with sections 1847A(i) and
1860D–14B of the Act. This rulemaking
also proposes new policies for the
Medicare Prescription Drug Inflation
Rebate Program, including removal of
units of drugs subject to discarded drug
refunds from the Part B rebate amounts,
exclusion of units for which a
manufacturer provides a discount under
the 340B Program from the Part D
inflation rebate amount starting on
January 1, 2026, the process for
reconciliation of a Part B or Part D
rebate amount to incorporate certain
revised information, and procedures for
imposing civil money penalties on
manufacturers that do not pay Part B or
Part D inflation rebate amounts within
a specified period of time.
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, by clarifying the
requirements and intent of the program
regarding the provision of services. We
also aim to ensure RHCs are provided
flexibility in the services they offer,
including specialty and laboratory
services.
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This rulemaking also proposes to
further advance Medicare’s overall
value-based care strategy of growth,
alignment, and equity through the
Medicare Shared Savings Program
(Shared Savings Program) and the
Quality Payment Program. 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 also proposes
changes to Medicare regulations
regarding requirements for reporting
and returning Parts A and B
overpayments.
B. Summary of the Major Provisions
Please note, some sections of this
proposed rule contain a request for
information (RFI). In accordance with
the implementing regulations of the
Paperwork Reduction Act of 1995
(PRA), specifically 5 CFR 1320.3(h)(4),
these general solicitations are 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.
Respondents are encouraged to provide
complete but concise responses. These
RFIs are issued solely for information
and planning purposes; they do not
constitute a Request for Proposal (RFP),
applications, proposal abstracts, or
quotations. These RFIs do not commit
the U.S. Government to contract for any
supplies or services or make a grant
award. Further, CMS is not seeking
proposals through these RFIs 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 these RFIs; all
costs associated with responding to
these RFIs will be solely at the
interested party’s expense. Not
responding to these RFIs does not
preclude participation in any future
procurement, if conducted. It is the
responsibility of the potential
responders to monitor these RFI
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announcements for additional
information pertaining to these requests.
Please note that CMS will not respond
to questions about the policy issues
raised in these RFIs. CMS may or may
not choose to contact individual
responders. Such communications
would only serve to further clarify
written responses. Contractor support
personnel may be used to review RFI
responses. 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 these RFIs may
be used by the U.S. Government for
program planning on a non-attribution
basis. Respondents should not include
any information that might be
considered proprietary or confidential.
These RFIs 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. CMS may publicly
post the comments received, or a
summary thereof.
Section 1848 of the Social Security
Act (the Act) 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.
In this major proposed rule, we are
proposing to establish RVUs for CY
2025 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
Act (section II.D.)
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• Valuation of Specific Codes (section
II.E.)
• Evaluation and Management (E/M)
Visits (section II.F.)
• Enhanced Care Management (section
II.G.)
• Supervision of Outpatient Therapy
Services in Private Practices,
Certification of Therapy Plans of Care
with a Physician or NPP Order, and
KX Modifier Thresholds (section II.H.)
• Advancing Access to Behavioral
Health Services (section II.I.)
• Proposals on Medicare Parts A and B
Payment for Dental Services
Inextricably Linked to Specific
Covered Services (section II.J.)
• Payment for Skin Substitutes (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 Clinic (RHC) and
Federally Qualified Health Center
(FQHC) Conditions for Certification
and Conditions for Coverage (CfCs)
(section III.C.)
• Clinical Laboratory Fee Schedule:
Revised Data Reporting Period and
Phase-in of Payment Reductions
(section III.D.)
• Medicare Diabetes Prevention
Program (MDPP) (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 Services (§§ 410.10,
410.57, 410.64, 410.152) (section
III.H.)
• Medicare Prescription Drug Inflation
Rebate Program (section III.I.)
• Request for Information: Building
upon the MIPS Value Pathways
(MVPs) Framework to Improve
Ambulatory Specialty Care (section
III.J.)
• Expand Colorectal Cancer Screening
(section III.K.)
• Requirements for Electronic
Prescribing for Controlled Substances
for a Covered Part D Drug under a
Prescription Drug Plan or an MA–PD
Plan (section III.L.)
• Expand Hepatitis B Vaccine Coverage
(section III.M.)
• Low Titer O+ Whole Blood
Transfusion Therapy During Ground
Ambulance Transport (section III.N.)
• Medicare Parts A and B Overpayment
Provisions of the Affordable Care Act
(section III.O.)
• Updates to the Quality Payment
Program (section IV.)
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• Collection of Information
Requirements (section V.)
• Response to Comments (section VI.)
• Regulatory Impact Analysis (section
VII.)
C. Summary of Costs and Benefits
We have determined that this
proposed rule is economically
significant. We estimate the CY 2025
PFS conversion factor to be 32.3562
which reflects a 0.05 percent positive
budget neutrality adjustment required
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 removal
of the temporary 2.93 percent payment
increase for services furnished from
March 9, 2024, through December 31,
2024, as provided in the CAA, 2024. 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
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A. Background
In accordance with section 1848 of
the Social Security Act (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
service that reflects the general
categories of physician and practitioner
expenses, such as office rent and
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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
American Medical Association (AMA)
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 to develop
the indirect portion of the PE RVUs.
Prior to CY 2010, we primarily used the
PE/HR by specialty 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 physicians
and NPPs paid under the PFS using a
survey instrument and methods highly
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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 or how the PE/HR
data are used. 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 are not
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separately recognized by Medicare, nor
do we have a method to blend the PPIS
data with Medicare-recognized specialty
data.
Previously, we established PE/HR
values for various specialties without
SMS or supplemental survey data by
crosswalking them to other similar
specialties to estimate a proxy PE/HR.
For specialties that were part of the PPIS
for which we previously used a
crosswalked PE/HR, we instead used the
PPIS based PE/HR. We use crosswalks
for specialties that did not participate in
the PPIS. These crosswalks have been
generally established through notice and
comment rulemaking and are available
in the file titled ‘‘CY 2025 PFS proposed
rule PE/HR’’ on the CMS website under
downloads for the CY 2025 PFS
proposed rule at https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/PhysicianFeeSched/PFSFederal-Regulation-Notices.html.
For CY 2025, we have incorporated
the available utilization data for two
new specialties, Marriage and Family
Therapist (MFT) and Mental Health
Counselor (MHC), which we recognized
effective January 1, 2024, in accordance
with section 4121 of the CAA, 2023. We
are proposing to use proxy PE/HR
values for these new specialties, as there
are no PPIS data for these specialties, by
crosswalking the PE/HR as follows from
specialties that furnish similar services
in the Medicare claims data:
• Marriage and Family Therapist (MFT)
from Licensed Clinical Social
Workers; and
• Mental Health Counselor (MHC) from
Licensed Clinical Social Workers
These updates are reflected in the
‘‘CY 2025 PFS proposed rule PE/HR’’
file available on the CMS website under
the supporting data files for the CY 2025
PFS proposed rule at https://
www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/
PhysicianFeeSched/PFS-FederalRegulation-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.
lotter on DSK11XQN23PROD with PROPOSALS2
(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
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calculated from the refined direct PE
inputs in our PE database. For example,
if one service has a direct cost sum of
$400 from our PE database and another
service has a direct cost sum of $200,
the direct portion of the PE RVUs of the
first service would be twice as much as
the direct portion of the PE RVUs for the
second service.
(2) Indirect Costs
We allocate the indirect costs at the
code level based on the direct costs
specifically associated with a code and
the greater of either the clinical labor
costs or the work RVUs. We also
incorporate the survey data described
earlier in the PE/HR discussion. The
general approach to developing the
indirect portion of the PE RVUs is as
follows:
• For a given service, we use the
direct portion of the PE RVUs calculated
as previously described and the average
percentage that direct costs represent of
total costs (based on survey data) across
the specialties that furnish the service to
determine an initial indirect allocator.
That is, the initial indirect allocator is
calculated so that the direct costs equal
the average percentage of direct costs of
those specialties furnishing the service.
For example, if the direct portion of the
PE RVUs for a given service is 2.00 and
direct costs, on average, represent 25
percent of total costs for the specialties
that furnish the service, the initial
indirect allocator would be calculated
so that it equals 75 percent of the total
PE RVUs. Thus, in this example, the
initial indirect allocator would equal
6.00, resulting in a total PE RVU of 8.00
(2.00 is 25 percent of 8.00 and 6.00 is
75 percent of 8.00).
• Next, we add the greater of the work
RVUs or clinical labor portion of the
direct portion of the PE RVUs to this
initial indirect allocator. In our
example, if this service had a work RVU
of 4.00 and the clinical labor portion of
the direct PE RVU was 1.50, we would
add 4.00 (since the 4.00 work RVUs are
greater than the 1.50 clinical labor
portion) to the initial indirect allocator
of 6.00 to get an indirect allocator of
10.00. In the absence of any further use
of the survey data, the relative
relationship between the indirect cost
portions of the PE RVUs for any two
services would be determined by the
relative relationship between these
indirect cost allocators. For example, if
one service had an indirect cost
allocator of 10.00 and another service
had an indirect cost allocator of 5.00,
the indirect portion of the PE RVUs of
the first service would be twice as great
as the indirect portion of the PE RVUs
for the second service.
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• 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 healthcare 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 2025 PFS
proposed rule at https://www.cms.gov/
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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
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 the associated
direct scaling adjustments offset one
another.
lotter on DSK11XQN23PROD with PROPOSALS2
(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
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percentages for a given service do not
vary by the PC, TC, and global service.
We generally use an average of the
three most recent years of available
Medicare claims data to determine the
specialty mix assigned to each code.
Codes with low Medicare service
volume require special attention since
billing or enrollment irregularities for a
given year can result in significant
changes in specialty mix assignment.
We finalized a policy in the CY 2018
PFS final rule (82 FR 52982 through
59283) to use the most recent year of
claims data to determine which codes
are low volume for the coming year
(those that have fewer than 100 allowed
services in the Medicare claims data).
For codes that fall into this category,
instead of assigning a specialty mix
based on the specialties of the
practitioners reporting the services in
the claims data, we use the expected
specialty that we identify on a list
developed based on medical review and
input from expert interested parties. We
display this list of expected specialty
assignments as part of the annual set of
data files we make available as part of
notice and comment rulemaking and
consider recommendations from the
RUC and other interested parties on
changes to this list annually. 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
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61601
(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.
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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.
lotter on DSK11XQN23PROD with PROPOSALS2
(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
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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
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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: To calculate the
PE and MP RVUs, we exclude certain
specialties, such as NPPs paid at a
percentage of the PFS and low volume
specialties, from the calculation. These
specialties are included to calculate the
BN adjustment. They are displayed in
Table 1.
BILLING CODE P
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61603
TABLE 1: Specialties Excluded from Ratesetting Calculation
Specialty Description
Ambulatory surgical center
Nurse practitioner
Medical suooly company with certified orthotist
Medical sunnly company with certified prosthetist
Medical suooly company with certified prosthetist-orthotist
Medical sunnly company not included in 51 52, or 53.
Individual certified orthotist
Individual certified prosthetist
Individual certified prosthetist-orthotist
Medical sunnly company with registered pharmacist
Ambulance service suoolier e.g. private ambulance companies funeral homes, etc.
Public health or welfare agencies
Voluntarv health or charitable agencies
Mass immunization roster biller
Radiation therapy centers
All other sunnliers (e.g. drug and department stores)
Unknown suoolier/provider specialty
Certified clinical nurse specialist
Optician
Physician assistant
Hospital
SNF
Intermediate care nursing facility
Nursing facility other
HHA
Pharmacv
Medical suooly company with respiratory therapist
Department store
Grocery store
Sunnlier of oxvgen and/or oxvgen related eauipment (eff. 10/2/2007)
Pedorthic personnel
Medical sunnly company with pedorthic personnel
Rehabilitation Agency
Ocularist
Centralized Flu
Indirect Payment Procedure
Dentistry
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BILLING CODE C
• Crosswalk certain low volume
physician specialties: Crosswalk the
utilization of certain specialties with
relatively low PFS utilization to the
associated specialties.
• Physical therapy utilization:
Crosswalk the utilization associated
with all physical therapy services to the
specialty of physical therapy.
• Identify professional and technical
services not identified under the usual
TC and 26 modifiers: Flag the services
that are PC and TC services but do not
use TC and 26 modifiers (for example,
electrocardiograms). This flag associates
the PC and TC with the associated
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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 creating
the file consistent with the 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
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amount for that service; therefore, the
utilization file is modified to only
account for 16 percent of any service
that contains the assistant at surgery
modifier. Similarly, for those services to
which volume adjustments are made to
account for the payment modifiers, time
adjustments are applied as well. For
time adjustments to surgical services,
the intraoperative portion in the work
time file is used; where it is not present,
the intraoperative percentage from the
payment files used by contractors to
process Medicare claims is used instead.
Where neither is available, we use the
payment adjustment ratio to adjust the
time accordingly. Table 2 details the
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Specialty
Code
49
50
51
52
53
54
55
56
57
58
59
60
61
73
74
87
88
89
96
97
AO
Al
A2
A3
A4
A5
A6
A7
A8
Bl
B2
B3
B4
B5
Cl
C2
C5
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manner in which the modifiers are
applied.
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.
We note that for CY 2025, we are
proposing mandatory use of the 54 and
55 modifiers when practitioners
furnishing global surgery procedures
share in patient care and intend only to
furnish preoperative/intraoperative or
postoperative portions of the total global
procedure. If finalized, this proposal
will likely increase the number of
claims subject to the adjustment
described in the discussion above. We
discuss this proposal in section II.G. of
this proposed rule.
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
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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
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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
types of equipment, the vast majority of
which fall in the range of 5 to 10 years,
and none of which are lower than two
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
data sources containing equipment
maintenance rates, commenters could
not identify an auditable, robust data
source that CMS could use on a wide
scale. We noted that we did not believe
voluntary submissions regarding the
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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.
TABLE 3: SBA Maximum Interest Rates
Useful Life
<7 Years
<7 Years
<7 Years
7+ Years
7+ Years
7+ Years
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We are not proposing any changes to
the equipment interest rates for CY
2025.
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 ensure 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 cost share weights in
the Medicare Economic Index (MEI). In
the past, we have proposed (and
subsequently finalized) to accomplish
this by holding the work RVUs constant
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Interest Rate
7.50%
6.50%
5.50%
8.00%
7.00%
6.00%
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 in 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.
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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 MEI to reflect
more current market conditions faced by
physicians in furnishing physicians’
services (referred to as the ‘‘2017-based
MEI’’). We also finalized a delay of the
adjustments to the PE pools in steps 3
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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
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 the AMA’s
intent to collect practice cost data from
physician practices, which could be
used to derive cost share weights for the
MEI and RVU shares.
In light of the AMA’s current data
collection efforts 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, similar to our
discussion of this topic in the CY 2024
PFS rulemaking cycle (88 FR 78829
through 78831), we continue to believe
that delaying the implementation of the
finalized 2017-based MEI cost share
weights for the RVUs is consistent with
our efforts to balance payment stability
and predictability with incorporating
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new data through more routine updates.
For these reasons, we did not propose
to incorporate the 2017-based MEI in
PFS ratesetting for CY 2024. As we
noted in the CY 2024 PFS final rule,
many commenters on the CY 2024 PFS
proposed rule supported our continued
delayed implementation of the 2017based MEI in PFS ratesetting (88 FR
78830). Most of these commenters urged
us to pause consideration of other
sources for the MEI until the AMA’s
efforts to collect practice cost data from
physician practices have concluded,
although a few commenters
recommended that we implement the
MEI for PFS ratesetting as soon as
possible. We agree with the commenters
that it would be prudent, and avoid
potential duplication of effort, to wait to
consider other data sources for the MEI
while the AMA’s data collection
activities are ongoing. As we discussed
in the CY 2024 PFS final rule, we
continue to monitor the data available
related to physician services’ input
expenses, but we are not proposing to
update the data underlying the MEI cost
weights at this time. Given our
previously described policy goal to
balance PFS payment stability and
predictability with incorporating new
data through more routine updates to
the MEI, we are not proposing to
incorporate the 2017-based MEI in PFS
ratesetting for CY 2025. We invite
comments on this approach as well as
any information on the timing of the
AMA’s practice cost data collection
efforts and other sources of data we
could consider for updating the MEI.
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 2025 direct PE input
public use files, which are available on
the CMS website under downloads for
the CY 2025 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
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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 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 the relativity of values among
codes. For example, as medical practice
and technologies change over time,
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
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case, 4 minutes as the standard for the
complex case, and 5 minutes as the
standard for the highly complex case.
These values were based upon a review
of the existing minutes assigned for this
clinical labor activity; we determined
that 2 minutes is the duration for most
services and a small number of codes
with more complex forms of digital
imaging have higher values. We also
finalized standard times for a series of
clinical labor tasks associated with
pathology services in the CY 2016 PFS
final rule with comment period (80 FR
70902). We do not believe these
activities would be dependent on
number of blocks or batch size, and we
believe that the finalized standard
values accurately reflect the typical time
it takes to perform these clinical labor
tasks.
In reviewing the RUC-recommended
direct PE inputs for CY 2019, we
noticed that the 3 minutes of clinical
labor time traditionally assigned to the
‘‘Prepare room, equipment and
supplies’’ (CA013) clinical labor activity
were split into 2 minutes for the
‘‘Prepare room, equipment and
supplies’’ activity and 1 minute for the
‘‘Confirm order, protocol exam’’
(CA014) activity. We proposed to
maintain the 3 minutes of clinical labor
time for the ‘‘Prepare room, equipment
and supplies’’ activity and remove the
clinical labor time for the ‘‘Confirm
order, protocol exam’’ activity wherever
we observed this pattern in the 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
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CA014 clinical labor activity code did
not contain any clinical labor for the
CA007 activity. In these situations, we
believe that the three 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. We direct readers to the
discussion in the CY 2019 PFS final rule
(83 FR 59463 through 59464) for
additional details.
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 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 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 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. We direct readers to the
discussion in the CY 2020 PFS final rule
(84 FR 62584) for additional details.
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 the
RUC’s development and our review of
code values for individual codes.
Beginning with its recommendations for
CY 2019, the RUC mandated the use of
a new PE worksheet for its
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 helps
us simplify and standardize the
hundreds of clinical labor tasks
currently listed in our direct PE
database. As in previous calendar years,
to facilitate rulemaking for CY 2025, we
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are continuing to display two versions
of the Labor Task Detail public use file:
one version with the old listing of
clinical labor tasks and one with the
same tasks crosswalked to the new
listing of clinical labor activity codes.
These lists are available on the CMS
website under downloads for the CY
2025 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 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 2025, we are proposing to
update the price of 17 supplies and one
equipment item in response to the
public submission of invoices following
the publication of the CY 2024 PFS final
rule. The 18 supply and equipment
items with proposed updated prices are
listed in the valuation of specific codes
section of the preamble under Table 16,
CY 2025 Invoices Received for Existing
Direct PE Inputs.
An interested party submitted 30
invoices to update pricing for the
human amniotic membrane allograft
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mounted on a non-absorbable selfretaining ring (SD248) supply. We
previously updated the price of this
supply in the CY 2024 final rule (88 FR
78901) based on averaging together the
price of the Prokera Slim, Prokera
Classic, and Prokera Plus devices. The
interested party submitted new invoices
for all three of these devices which
averaged to a new price of $1149.00
which we are proposing for the SD248
supply. We are soliciting additional
comments from interested parties
regarding the price of the SD248 supply
as well as any information as far as
whether one of these three devices (the
Prokera Slim, Prokera Classic, and
Prokera Plus) would be more typical
than the other two for use as a supply
in CPT code 65778.
In the case of the indocyanine green
(25ml uou) (SL083) supply, we noticed
that there was a clear bimodal
distribution of prices on the eight
submitted invoices, clustered around
$91.00 and $141.67, respectively, with
no pricing in between $100 and $140.
We are proposing the updated total
average price of $125.11 based on the
eight submitted invoices for the SL083
supply, however, we are soliciting
comments on why there was such
divergence in the pricing on the
submitted invoices, as well as whether
these may represent pricing for two
different supplies.
Regarding the Reaction buffer 10X
(Ventana 950–300) (SL478) supply, we
are proposing to update the price from
$0.037 to $0.045, which is less than the
$0.075 contained on the invoice
submitted by interested parties. We
were able to find this product readily
available for purchase online at a
quantity of 10 liters for $453 or a price
of $0.045. We do not believe that it
would be typical for providers to pay a
higher price based on smaller unit
quantities; therefore, we are proposing
to update the price of the SL478 supply
but only to $0.045, which is the price
to purchase this supply online, as stated
above.
Interested parties also alerted CMS to
a technical correction for pricing the
Atomizer tips (disposable) (SL464)
supply. We previously finalized a price
of $2.66 for the SL464 supply, which
was included in the table of Invoices
Received for Existing Direct PE Inputs
in the CY 2018 final rule (82 FR 53162).
However, due to a technical error, the
updated pricing for the SL464 supply
was never implemented. We are
proposing to make this correction for CY
2025; the corrected price of $2.66 for the
SL464 supply is included in Table 16.
We are not proposing to update the
price of another ten supplies, which
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were the subject of public submission of
invoices. Our reasons for not proposing
updates to these prices are detailed
below, and we are seeking additional
information from interested parties for
assistance in pricing these supplies:
• Liposorber supplies: Tubing set
(SC083), Plasma LDL adsorption column
(SD186), and Plasma separator (SD188):
We received invoices for these three
Liposorber supplies from an interested
party. However, it was unclear from the
invoice submissions what the unit
quantity size is for each product. We
require additional information regarding
the unit size of each supply included on
these invoices to establish updated
pricing, and therefore, we are not
proposing updates to the prices for these
supplies. We are seeking additional
comments regarding the pricing of these
supplies and whether the pricing has
increased so dramatically, as it seems
unlikely that prices have tripled in the
five years since we most recently
updated the pricing for these supplies.
• Congo Red kits (SA110): We
received three invoices from interested
parties requesting an increase in the
price of the SA110 supply from $6.80 to
$18.78. However, we were able to find
Congo Red staining kits readily
available online at a price of 100 for
$410 or $4.10 per kit. The unit size of
these kits was also unclear, which made
price comparisons with the submitted
invoices difficult. Based on the three
invoices and the online price of 100 for
$410 or $4.10 per kit, we do not believe
there is enough pricing data to support
an increase in the price of the SA110
supply from $6.80 to $18.78, and we are
not proposing an increase in the price
of this supply.
• Gauze, non-sterile 4in x 4in
(SG051): We received one invoice from
interested parties requesting an increase
in the price of the SG051 supply from
$0.03 to $0.04. However, the submitted
invoice price appeared to be for surgical
gauze, not non-sterile gauze. We were
able to find the 4x4 non-sterile gauze
readily available online at less than the
invoice price. Based on this
information, we do not believe there is
enough pricing data to support an
increase in the price of the SG051
supply from $0.03 to $0.04, and we are
not proposing an increase in the price
of this supply.
• Permanent marking pen (SL477):
We received one invoice from interested
parties requesting an increase in the
price of the SL477 supply from $2.81 to
$4.62. However, we found black
marking pens, such as Sharpies, widely
available at unit prices around $2.00
when purchased in larger quantities.
Based on this information, we do not
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believe there is enough pricing data to
support an increase in the price of the
SL477 supply from $2.81 to $4.62, and
we are not proposing an increase in the
price of this supply.
• Hematoxylin II (Ventana 790–2208)
(SL483): We received four invoices from
interested parties requesting an increase
in the price of the SL483 supply from
$0.780 to $2.722. However, we were
able to find hematoxylin II stains readily
available online at cheaper prices, such
as $52.00 for 500 ml ($0.104 per ml).
Based on this information, we do not
believe there is enough pricing data to
support an increase in the price of the
SL483 supply from $0.780 to $2.722,
and we are not proposing an increase in
the price of this supply.
• Bluing reagent (Ventana 760–2037)
(SL484): We received three invoices
from interested parties requesting an
increase in the price of the SL484
supply from $4.247 to $6.130. While
researching the pricing of the SL484
supply, we were unable to determine
the unit quantity size on invoices,
which made it difficult to evaluate if the
requested price accurately reflected
market pricing. As best we could tell,
the requested price increase to $6.130
was more expensive than comparable
online bluing reagents available for
purchase. Based on this information, we
do not believe there is enough pricing
data to support an increase in the price
of the SL484 supply from $4.247 to
$6.130, and we are not proposing an
increase in the price of this supply.
• EZ Prep (10X) (Ventana 950–102)
(SL481) and 250 Test Prep Kit # 78
(Ventana 786–3034) (SL486): In each of
these cases, we received invoices from
interested parties requesting substantial
increases in the price of the associated
supplies, from $0.034 to $0.509 for the
SL481 supply and from $0.309 to $2.134
for the SL486 supply. We do not believe
that it is reasonable to expect that the
typical market prices for these supplies
have increased by 1400 percent and 600
percent, respectively, in the 5 years
since we most recently updated the
pricing for these supplies. The limited
pricing information we could find
online for each product also failed to
support these drastic increases in
pricing. Based on this information, we
do not believe there is enough pricing
data to support the requested increases
for the SL481 and SL486 supplies, and
we are not proposing increases to the
prices for these supplies.
(1) Invoice Submission
We remind readers that we routinely
accept public submissions of invoices as
part of our process for developing
payment rates for new, revised, and
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potentially misvalued codes. Often,
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.
In recent years, we have noticed a
growing number of invoice submissions
for use in updating supply and
equipment pricing. Although we
continue to believe in the importance of
using the most recent and accurate
invoice data to reflect current market
pricing, we do have some concerns that
the increased use of these submissions
may distort relativity across the fee
schedule. Relying on voluntary invoice
submissions to update pricing for a
small subset of the total number of
supply and equipment items in our
database, while leaving the
overwhelming majority of prices
untouched, could be distorting pricing
in favor of the most recent submissions.
We believe that it may be more efficient,
and more accurate, to update supply
and equipment pricing in a more
comprehensive fashion similar to the
pricing update that took place from CY
2019 to CY 2022. For example, future
updates to supply and equipment
pricing could take place in tandem with
updates to clinical labor pricing after
the current clinical labor update
concludes in CY 2025. We welcome
public comments on this general topic
of more comprehensive updates to
supply and equipment pricing, and we
may consider comments we receive to
inform future rulemaking.
(2) Supply Pack Pricing Update
Interested parties previously notified
CMS that they identified numerous
discrepancies between the aggregated
cost of some supply packs and the
individual item components contained
within. The interested parties indicated
that CMS should rectify these
mathematical errors as soon as possible
to ensure that the sum correctly matches
the totals from the individual items, and
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they recommended that we resolve
these pricing discrepancies in the
supply packs during CY 2024
rulemaking. The AMA RUC convened a
workgroup on this subject and
submitted recommendations to update
pricing for a series of supply packs
along with the RUC’s comment letter for
the CY 2024 rule cycle.
We appreciated the additional
information and RUC workgroup
recommendations regarding
discrepancies in the aggregated cost of
some supply packs. However, due to the
projected significant cost revisions in
the pricing of supply packs and because
we did not propose to address supply
pack pricing in the CY 2024 proposed
rule, we stated that this issue would be
better addressed in future rulemaking.
For example, the cleaning and
disinfecting endoscope pack (SA042) is
included as a supply input in more than
300 HCPCS codes, which could have a
sizable impact on the overall valuation
of these services, and which was not
incorporated into the proposed RVUs
published for the CY 2024 proposed
rule. We stated that interested parties
would be better served if we
comprehensively addressed this topic
during future rulemaking in which
commenters could provide feedback in
response to proposed pricing updates
(88 FR 78833 through 78834).
For CY 2025, we are proposing to
implement the supply pack pricing
update and associated revisions as
recommended by the RUC’s workgroup.
We are proposing to update the pricing
of the ‘‘pack, cleaning and disinfecting,
endoscope’’ (SA042) supply from $19.43
to $31.29, to update the pricing of the
‘‘pack, drapes, cystoscopy’’ (SA045)
supply from $17.33 to $14.99, to update
the pricing of the ‘‘pack, ocular
photodynamic therapy’’ (SA049) supply
from $16.35 to $26.35, to update the
pricing of the ‘‘pack, urology cystoscopy
visit’’ (SA058) supply from $113.70 to
$37.63, and to update the pricing of the
‘‘pack, ophthalmology visit (wdilation)’’ (SA082) supply from $3.91 to
$2.33. As recommended by the RUC
workgroup, we are also proposing to
delete the ‘‘pack, drapes, laparotomy
(chest-abdomen)’’ (SA046) supply
entirely. The proposed updated prices
for these supply packs are listed in the
valuation of specific codes section of the
preamble under Table 16, CY 2025
Invoices Received for Existing Direct PE
Inputs.
In accordance with the RUC
workgroup’s recommendations, we are
also proposing to create eight new
supply codes, including components
contained within previously existing
supply packs. Aside from the SB056
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61609
supply, which is a replacement in
several HCPCS codes for the deleted
SA046 supply pack, all of these new
supplies are not included as standalone
direct PE inputs in any current HCPCS
codes, as they are, again, components
contained within previously existing
supply packs. We are proposing to add:
• The kit, ocular photodynamic
therapy (PDT) (SA137) supply at a price
of $26.00 as a component of the SA049
supply pack;
• The Abdominal Drape Laparotomy
Drape Sterile (100 in x 72 in x 124 in)
(SB056) supply at a price of $8.049 as
a replacement for the SA046 supply
pack;
• The drape, surgical, legging (SB057)
supply at a price of $3.284 as a
component of the SA045 supply pack;
• The drape, surgical, split,
impervious, absorbent (SB058) supply at
a price of $8.424 as a component of the
SA045 supply pack;
• The post-mydriatic spectacles
(SB059) supply at a price of $0.328 as
a component of the SA082 supply pack;
• The y-adapter cap (SD367) supply
at a price of $0.352 as a component of
the SA049 supply pack;
• The ortho-phthalaldehyde 0.55%
(e.g., Cidex OPA) (SM030) supply at a
price of $0.554 as a component of the
SA042 supply pack; and
• The ortho-phthalaldehyde test
strips (SM031) supply at a price of
$1.556 as a component of the SA042
supply pack.
The proposed new supply pack
component items are listed in the
valuation of specific codes section of the
preamble under Table 17, CY 2025 New
Invoices.
We are also proposing the following
additional supply substitutions based
on the recommendations of the RUC
workgroup. We are proposing to remove
the deleted SA046 supply pack and
replace it with the drape, sterile,
fenestrated 16in x 29in (SB011) supply
for CPT codes 19020, 19101, 19110,
19112, 20101, and 20102. We are
proposing to remove the deleted SA046
supply pack and replace it with two
supplies—the drape, sterile, threequarter sheet (SB014) and the drape,
towel, sterile 18in x 26in (SB019)—for
CPT codes 19000 and 60300. We are
proposing to remove the deleted SA046
supply pack and replace it with two
supplies—the drape, towel, sterile 18in
× 26in (SB019) and the newly created
Abdominal Drape Laparotomy Drape
Sterile (100 in × 72 in × 124 in) (SB056)
supply—for CPT codes 22510, 22511,
22513, and 22514. We are proposing to
remove the deleted SA046 supply pack
without replacing it with anything for
CPT code 22526; the RUC workgroup
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did not make a recommendation on
what to do with CPT code 27278, which
also previously contained the SA046
supply pack. Therefore, we are also
proposing not to replace the SA046
supply pack with any supplies for this
code. The RUC workgroup also
recommended removing the SA046
supply pack from CPT code 64595 with
no replacement; however, this code was
recently reviewed at the April 2022 RUC
meeting and it no longer includes the
SA046 supply.
The RUC workgroup also reviewed
the issue of skin adhesives and
identified several generic alternatives to
using the skin adhesive (Dermabond)
(SG007) supply. The workgroup stated
that there are multiple skin adhesive
products, at different price points,
available that work similarly to
Dermabond and requested that generic
alternatives be used overall in place of
brand names in the CMS direct PE
database. The workgroup made a series
of suggestions for CMS to create new
medical supply item codes to
encompass the generic formulations of
cyanoacrylate skin adhesive in
multidose form and single use sterile
application.
We appreciate the recommendations
from the RUC workgroup and concur
that generic alternatives be used in
place of brand names, where
appropriate, in the CMS direct PE
database. However, we have no pricing
information or submitted invoices for
the four generic formulations of
cyanoacrylate skin adhesive requested
by the RUC workgroup (2-Octylcyanoacrylate, n-Butyl-2-cyanoacrylate,
Combined n-Butyl and 2Octylcyanoacrylate, and Ethyl-2cyanoacrylate). Since these four
potential new supplies have no pricing
information and are not currently
included as direct PE inputs for any
HCPCS codes, we have not added them
to our direct PE database for the CY
2025 proposed rule due to lack of
available information.
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
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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, several 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 updating the clinical labor
pricing was important 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
PO 00000
Frm 00016
Fmt 4701
Sfmt 4702
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 setting PE RVUs under the
PFS. We used the most current BLS
survey data (2019) as the main source of
wage data for our CY 2022 clinical labor
proposal.
We recognized that the BLS survey of
wage data does not cover all the staff
types contained in our direct PE
database. Therefore, we crosswalked or
extrapolated the wages for several staff
types using supplementary data sources
for verification whenever possible. In
situations where the price wages of
clinical labor types were not referenced
in the BLS data, we used the national
salary data from the Salary Expert, an
online project of the Economic Research
Institute that surveys national and local
salary ranges and averages for thousands
of job titles using mainly government
sources. (A detailed explanation of the
methodology used by Salary Expert to
estimate specific job salaries can be
found at www.salaryexpert.com.) We
previously used Salary Expert
information as the primary backup
source of wage data during the last
update of clinical labor pricing in CY
2002. If we did not have direct BLS
wage data available for a clinical labor
type, we used the wage data from Salary
Expert as a reference for pricing, then
crosswalked these clinical labor types to
a proxy BLS labor category rate that
most closely matched the reference
wage data, similar to the crosswalks
used in our PE/HR allocation. For
example, there is no direct BLS wage
data for the Mammography Technologist
(L043) clinical labor type; we used the
wage data from Salary Expert as a
reference and identified the BLS wage
data for Respiratory Therapists as the
best proxy category. We calculated rates
for the ‘‘blend’’ clinical labor categories
by combining the rates for each labor
type in the blend and then dividing by
the total number of labor types in the
blend.
As in the CY 2002 clinical labor
pricing update, the proposed cost per
minute for each clinical staff type was
derived by dividing the average hourly
wage rate by 60 to arrive at the per
minute cost. In cases where an hourly
wage rate was not available for a clinical
staff type, the proposed cost per minute
for the clinical staff type was derived by
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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 instead of 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 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 perminute 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
61611
supply and equipment update.
Therefore, we finalized the clinical
labor pricing update implementation
over four 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 onequarter of the difference between the
current price and the fully phased-in
price is implemented for CY 2022, onethird 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.
TABLE 4: Example of Clinical Labor Pricing Transition
1/4 difference between $1.00 and $2.00
1/3 difference between $1.25 and $2.00
1/2 difference between $1.50 and $2.00
(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,
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20:32 Jul 30, 2024
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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).
(2) CY 2024 Clinical Labor Pricing
Updates
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
PO 00000
Frm 00017
Fmt 4701
Sfmt 4702
proposed clinical labor pricing for CY
2024 was 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.
Based on comments received on the CY
2024 proposed rule, we finalized an
update in the clinical labor pricing of
the cytotechnologist (L045A) clinical
labor type from $0.76 to $0.85 based on
submitted data from the 2021 American
Society of Clinical Pathologists (ASCP)
Wage Survey of Medical Laboratories
(88 FR 78838).
(3) CY 2025 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
2025 PFS proposed rule. Therefore, our
proposed clinical labor pricing for CY
2025 in Table 5 is based on the clinical
labor pricing that we finalized in the CY
2024 PFS final rule, incremented an
additional step for the final Year 4 of the
update:
BILLING CODE P
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31JYP2
EP31JY24.003
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rice
61612
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
L032B
L033A
L033B
L035A
L037A
L037B
L037C
L037D
L037E
L038A
L038B
L038C
L039A
L039B
L039C
L041A
L041B
L041C
L042A
L042B
L043A
L045A
L045B
L045C
L046A
L047A
lotter on DSK11XQN23PROD with PROPOSALS2
L047B
L047C
L047D
L049A
L050A
L050B
L050C
L050D
L051A
L051B
L051C
L052A
L053A
L054A
L055A
L056A
L057A
L057B
L063A
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Medica1/Technical Assistant
Lab Tech/MTA
EEG Technician
Lab Technician
tician/COMT
Electro
Risto
Ortho
RN/LPN/MTA
Child Life S ecialist
COMT/COT/RN/CST
st
Cardiovascular Technician
Medical Photo
her
er
p
p chometrist
Vascular lnterventional Technolo ·st
Radiolo
Second Radiologic Technologist for
Vertebro las
RN/LPN
st
CORF soc
CT Technolo •st*
MRI Technolo •st
REEGT (Electroencephalographic
Tech
RN/Re •stered Dietician
Nuclear Medicine Technolo •st
Radiation Thera ist
Second Radiation Thera ist for IMRT
RN
RN/Dia ostic Medical Sono
her
RN/CORF
Genetics Counselor
Behavioral Health Care Mana er
Medical Dosimetrist
20:32 Jul 30, 2024
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PO 00000
BLS 29-2098
BLS 29-2010
BLS 29-2081 BLS 29-2057
L033A L037B
BLS 29-2098
BLS 29-2010
BLS 29-1141
L051A ELS 29-2061 L026A
BLS 21-1021
BLS 29-2057, BLS 29-2055,
L051A, ELS 19-4010
BLS 29-2031
BLS 29-2050
BLS 29-9000
BLS 31-2021
BLS 21-1029
ASRT Wa e Data
BLS 29-2034
0.32
0.33
0.33
0.35
0.37
0.37
0.37
0.37
0.37
0.44
0.55
0.39
0.60
0.44
0.64
0.76
0.54
0.49
38%
53%
38%
67%
18%
70%
19%
73%
105%
46%
32%
0.38
0.52
37%
0.38
0.38
0.39
0.39
0.39
0.41
0.41
0.60
0.38
0.52
0.61
0.64
0.84
0.63
58%
0%
33%
56%
62%
104%
54%
BLS 29-2034
0.41
0.63
54%
L051A, ELS 29-2061
BLS 29-1126
ASRT Wa e Data
BLS 29-9092
BLS 29-1124
BLS 21-1022, ELS 19-3031
ASRT Wa e Data
BLS 29-2035
0.42
0.42
0.43
0.45
0.45
0.45
0.46
0.47
0.63
0.64
0.79
0.85
0.89
0.70
0.78
0.76
50%
52%
84%
89%
98%
56%
70%
62%
BLS 29-2035
0.47
0.76
62%
L051A, L042B
L051A, ELS 29-1031
BLS 29-2033
BLS 29-2032
BLS 29-2032
BLS 29-1124
BLS 29-1124
BLS 29-1141
L051A, ELS 29-2032
L051A
BLS 29-1181
L051A, L055A
BLS 19-1040
BLS 29-1127
BLS 29-2033
BLS 29-9092
BLS 21-1018
BLS 19-1040
0.47
0.47
0.62
0.50
0.50
0.50
0.50
0.51
0.51
0.51
0.52
0.53
0.54
0.55
0.79
0.57
0.57
0.63
0.70
0.70
0.81
0.77
0.77
0.89
0.89
0.76
0.77
0.76
0.81
0.79
0.91
0.82
0.81
0.85
0.57
0.91
49%
49%
32%
54%
54%
78%
78%
49%
51%
49%
56%
49%
69%
49%
3%
50%
0%
44%
Frm 00018
Fmt 4701
Sfmt 4725
E:\FR\FM\31JYP2.SGM
31JYP2
EP31JY24.004
TABLE 5: Proposed CY 2025 Clinical Labor Pricing
Ll07A
Ll52A
Medical Dosimetrist/Medical
Ph 'Sicist
Medical P sicist
BILLING CODE C
As was the case for the market-based
supply and equipment pricing update,
the clinical labor rates will remain open
for public comment during the 60-day
comment period for this CY 2025 PFS
proposed rule. We expect to set the
updated clinical labor rates for CY 2025
in the final rule. We updated the pricing
of some clinical labor types in the CY
2022, CY 2023, and CY 2024 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).
lotter on DSK11XQN23PROD with PROPOSALS2
5. Development of 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 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
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L063A, Ll52A
1.08
1.52
41%
AAPMWa eData
1.52
2.14
41%
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 (Pub. L. 106–
113, November 29, 1999) (BBRA)
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
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background on the refinements that we
considered after the transition began, we
refer readers to discussions in the CY
2011 through 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
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
through 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
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on strategies to update PE data
collection and methodology (87 FR
69429 through 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 reminded
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 previous rulemaking,
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 our CY 2023 and CY 2024
rules 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.
b. Preparation for Incorporating
Refreshed Data and Request for
Information on Timing To Effectuate
Routine Updates
In the CY 2024 PFS proposed rule, we
continued 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. Considering our
ratesetting methodology and prior
experiences implementing new data, we
issued a follow-up from the CY 2023
comment solicitation for general
information. We solicited 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
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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 sought 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 the 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 response to last year’s RFI, most
commenters stated that CMS should
defer significant changes until the AMA
PPIS results become available. For
further background, refer to 88 FR 78841
to 78843. In responding to our RFI, the
AMA RUC provided a set of responses,
which many other commenters repeated
in their separate, individual comments.
In summary, the AMA RUC letter
submission from CY 2024 suggested that
CMS should not consider further
changes until PPIS data collection and
analysis is complete. Overall, the AMA
comments generally do not support any
change to the methodology and stated
that CMS should wait to consider any
further changes until PPIS updates
become available. Further, we noted
that through its contractor,
Mathematica, the AMA secured an
endorsement for the PPIS updates from
each State society, national medical
specialty society, and others prior to
fielding the survey (88 FR 78843). Refer
to the AMA’s summary of the PPIS,
available at https://www.ama-assn.org/
system/files/physician-practiceinformation-survey-summary.pdf. The
AMA expects analysis, reporting, and
documentation to complete by the end
of CY 2024, and the AMA would share
data with CMS when results become
available.
We believe the AMA’s approach may
possibly mitigate nonresponse bias,
which created challenges using previous
PPIS data. However, we remain
uncertain about whether endorsements
prior to fielding the survey may inject
other types of bias in the validity and
reliability of the information collected.
We believe it remains important to
reflect on the challenges with our
current methodology, and to continue to
consider alternatives that improve the
stability and accuracy of our overall PE
methodology. We reiterate our
discussion summarizing the responses
to previous years’ RFIs in each of the CY
2023 and CY 2024 final rules (refer to
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87 FR 69429 through 69432 and 88 FR
78841 to 78843). We have started new
work under contract with the RAND
Corporation to analyze and develop
alternative methods for measuring PE
and related inputs for implementation
of updates to payment under the PFS.
We continue to study possible
alternatives, and would include analysis
of updated PPIS data, as part of our
ongoing work. In the meantime, we
request general information from the
public on ways that CMS may continue
work to improve the stability and
predictability of any future updates.
Specifically, we request feedback from
interested parties regarding scheduled,
recurring updates to PE inputs for
supply and equipment costs.
We believe that establishing a cycle of
timing to update supply and equipment
cost inputs every 4 years may be one
means of advancing shared goals of
stability and predictability. CMS would
collect available data, including, but not
limited to, submissions and
independent third-party data sources,
and propose a phase-in period over the
following 4 years. The phase-in
approach maps to our experience with
previous updates. Additionally, we
believe that more frequent updates may
have the unintended consequence of
disproportionate effects of various
supplies and equipment that have
newly updated costs.
Further, we seek feedback on possible
mechanisms to establish a balance
whereby our methodology would
account for inflation and deflation in
supply and equipment costs. We remain
uncertain how economies of scale
(meaning a general principle that cost
per unit of production decreases as the
scale of production increases) should or
should not factor into future
adjustments to our methodology. There
remains a diversity of perspectives
among interested parties about such
effects. We seek information about
specific mechanisms that may be
appropriate, and in particular,
approaches that would leverage
verifiable and independent, third-party
data that is not managed or controlled
by active market participants.
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
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certain criteria and to review and make
appropriate adjustments to the relative
values for those services. Section
1848(c)(2)(L) of the Act also requires the
Secretary to develop a process to
validate the RVUs of certain potentially
misvalued codes under the PFS, using
the same criteria used to identify
potentially misvalued codes, and to
make appropriate adjustments.
As discussed in section II.E. of this
proposed rule, 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 (RBRVS) 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 the
Veterans Health Administration (VHA),
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
consider information provided by other
interested parties such as from the
general medical-related community and
the public. We conduct a review to
assess the appropriate RVUs in the
context of contemporary medical
practice. We note that section
1848(c)(2)(A)(ii) of the Act authorizes
the use of extrapolation and other
techniques to determine the RVUs for
physicians’ services for which specific
data are not available and requires us to
take into account the results of
consultations with organizations
representing physicians who provide
the services. In accordance with section
1848(c) of the Act, we determine and
make appropriate adjustments to the
RVUs.
In its March 2006 Report to the
Congress (https://www.medpac.gov/
document/report-to-the-congress-2006medicare-payment-policy/), MedPAC
discussed the importance of
appropriately valuing physicians’
services, noting that misvalued services
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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-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.
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• 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 current processes for
consideration of coding changes), which
may involve consolidating 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
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misvalued codes established in the CY
2012 PFS final rule with comment
period (76 FR 73026, 73058 through
73059), other individuals and groups
submit nominations for review of
potentially misvalued codes as well.
Individuals and groups may submit
codes for review under the potentially
misvalued codes initiative to CMS in
one of two ways. Nominations may be
submitted to CMS via email or through
postal mail. Email submissions should
be sent to the CMS emailbox at
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
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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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
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 2025 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.
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• 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, their associated
organization, and the submitted studies
for full transparency. We sometimes
receive submissions for specific, PErelated 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 2025,
we received 5 nominations concerning
various codes. The nominations are as
follows:
(1) CPT Codes 22210, 22212, 22214,
22216
An interested party nominated CPT
codes 22210 (Osteotomy of spine,
posterior or posterolateral approach, 1
vertebral segment; cervical) (090 day
global code), 22212 (Osteotomy of spine,
posterior or posterolateral approach, 1
vertebral segment; thoracic) (090 day
global code), 22214 (Osteotomy of spine,
posterior or posterolateral approach, 1
vertebral segment; lumbar) (090 day
global code), and 22216 (Osteotomy of
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spine, posterior or posterolateral
approach, 1 vertebral segment; each
additional vertebral segment (List
separately in addition to primary
procedure) (add-on ZZZ) as potentially
misvalued for six reasons: (1) incorrect
global period; (2) incorrect inpatient
days; (3) incorrect intraservice work
description; (4) overvalued intraservice
times; (5) changed surgical practice; and
(6) incorrect use of posterior osteotomy
codes. The posterior osteotomy codes
were last valued by the RUC in 1995.
Currently, CPT code 22210 has a work
RVU of 25.38, CPT code 22212 has a
work RVU of 20.99, CPT code 22214 has
a work RVU of 21.02, and CPT code
22216 has a work RVU of 6.03. CPT
codes 22210, 22212, and 22214 have 7
inpatient days each, while CPT code
22216 has 0 inpatient days, and it is an
add-on code.
First, the nominator stated that these
posterior osteotomies are always
performed as an optional addition to a
spinal fusion and should be valued as
add-on services and not as 90-day global
services. We note that no references are
provided to support the statement that
the service is always performed as an
optional addition to a spinal fusion.
Second, the nominator explained that
the average hospital stay for scoliosis
fusion with osteotomy is 4 to 5 days
according to the current literature,2 3 4 in
contrast with the currently included 7
inpatient days. We note that the
majority of the medical literature
submitted by the nominator presented
outcome information on adolescent
patients, which may be different from
the Medicare population. Furthermore,
the nominator stated that the
intraservice work description for CPT
code 22216 describes removal of the
pedicle, which is not a typical part of a
Ponte/Schwab II osteotomy. Among the
posterior osteotomy codes, only CPT
code 22216 had vignettes and we do not
have information to decide whether the
code descriptor is correct. We believe
this issue would benefit from further
review by the medical community and
2 Halanski, Matthew Aaron, and Jeffrey A
Cassidy. ‘‘Do multilevel Ponte osteotomies in
thoracic idiopathic scoliosis surgery improve curve
correction and restore thoracic kyphosis?’’ Journal
of spinal disorders & techniques vol. 26,5 (2013):
252–5. doi:10.1097/BSD.0b013e318241e3cf.
3 Floccari, Lorena V et al. ‘‘Ponte osteotomies in
a matched series of large AIS curves increase
surgical risk without improving outcomes.’’ Spine
deformity vol. 9,5 (2021): 1411–1418. doi:10.1007/
s43390–021–00339–x.
4 Buckland, Aaron J et al. ‘‘Ponte Osteotomies
Increase the Risk of Neuromonitoring Alerts in
Adolescent Idiopathic Scoliosis Correction
Surgery.’’ Spine vol. 44,3 (2019): E175–E180.
doi:10.1097/BRS.0000000000002784.
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welcome comments and considerations,
including from the AMA CPT.
The nominator also asserted that
intraservice times were too high,
particularly for these osteotomy services
furnished with scoliosis fusion
procedures. The nominator explained
that a typical scoliosis fusion would be
billed with an intraservice time of up to
840 minutes for pediatric scoliosis
fusion and 915 minutes for adult cases.
However, referencing current literature,
they observed that a typical scoliosis
fusion in a child requires approximately
278 minutes (243–296 minutes),5 6 7
which contrasts significantly with the
durations indicated for the current
codes. The nominator provided no
studies to support a typical scoliosis
fusion time in adults. Drawing from the
literature, the nominators assert that
intraservice times are overvalued for
these services and propose that these
times should be adjusted to align more
closely with average and/or typical
surgery times.
The nominator further asserted that
this code family is potentially
misvalued because surgical practice for
these procedures has evolved since
1995. Approximately 30 years ago,
osteotomies were infrequently
performed and usually reserved for
addressing completely ankylosed or
fused spinal segments.8 However,
according to the nominator,
contemporary surgical techniques often
involve posterior osteotomies to release
multiple stiff vertebral segments,
thereby enhancing coronal correction
and reducing thoracic hypokyphosis. In
addition to changes in surgical
techniques over time, there are notable
shifts in the trends regarding the
utilization of osteotomies. For instance,
between 2007 and 2015, the use of
posterior osteotomies in scoliosis cases
nearly doubled, increasing from 17
5 Samdani, Amer F et al. ‘‘Do Ponte Osteotomies
Enhance Correction in Adolescent Idiopathic
Scoliosis? An Analysis of 191 Lenke 1A and 1B
Curves.’’ Spine deformity vol. 3,5 (2015): 483–488.
doi:10.1016/j.jspd.2015.03.002.
6 Pizones, Javier et al. ‘‘Ponte osteotomies to treat
major thoracic adolescent idiopathic scoliosis
curves allow more effective corrective maneuvers.’’
European spine journal: official publication of the
European Spine Society, the European Spinal
Deformity Society, and the European Section of the
Cervical Spine Research Society vol. 24,7 (2015):
1540–6. doi:10.1007/s00586–014–3749–1.
7 Feng, Jing et al. ‘‘Clinical and radiological
outcomes of the multilevel Ponte osteotomy with
posterior selective segmental pedicle screw
constructs to treat adolescent thoracic idiopathic
scoliosis.’’ Journal of orthopaedic surgery and
research vol. 13,1 305. 29 Nov. 2018, doi:10.1186/
s13018–018–1001–0.
8 Ponte, Alberto et al. ‘‘The True Ponte
Osteotomy: By the One Who Developed It.’’ Spine
deformity vol. 6,1 (2018): 2–11. doi:10.1016/
j.jspd.2017.06.006.
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61617
percent to 35 percent.9 Additionally, 73
percent of patients undergoing scoliosis
surgery received posterior osteotomies.4
This information supports the
nominator’s assertion that there have
been notable changes in the surgical
practice for these codes over time.
Lastly, the nominator highlighted
incorrect usage of posterior osteotomy
codes. They noted instances where
facet/soft tissue releases, such as
Schwab type I osteotomies, are
inaccurately reported with these codes.
According to the nominator, isolated
partial facetectomy and soft tissue
release are already included in spinal
fusion procedures and should not be
separately billed with an osteotomy
code. Additionally, CMS in reviewing
data for these services identified
potential bundling of services within
this code family. For instance, CPT code
22210 is frequently billed alongside CPT
code 22600 (Arthrodesis, posterior or
posterolateral technique, single
interspace; cervical below C2 segment)
(090-day global code), approximately 83
percent of the time. This indicates a
common billing pattern, suggesting
potential for coding revisions, including
the consideration of consolidating
individual services into bundled codes.
Overall, based on the six reasons
provided by the nominator, along with
the fact that these codes were last
valued almost 30 years ago, and given
the identified billing practices, we
concur that CPT codes 22210, 22212,
22214, and 22216 are potentially
misvalued. The nominator suggested
two options to address this concern: (1)
developing add-on codes to differentiate
between the number of vertebral
segments involved in the osteotomy
procedure and whether it occurs in the
cervical, thoracic, or lumbar regions;
and (2) removing the current posterior
osteotomy codes and incorporating
osteotomies into new deformity fusion
codes, both with and without
osteotomy. We are proposing to
consider this code family as potentially
misvalued and we appreciate the
detailed information submitted by the
nominator with sufficient supporting
evidence. We believe that this code
family would benefit from a
comprehensive review by the RUC, and
we welcome comments on a broader
understanding of these codes.
Additionally, we seek input on current
standard billing practices. For example,
information on whether the standard of
9 Shaheen, Mohammed et al. ‘‘Complication risks
and costs associated with Ponte osteotomies in
surgical treatment of adolescent idiopathic
scoliosis: insights from a national database.’’ Spine
deformity vol. 10,6 (2022): 1339–1348. doi:10.1007/
s43390–022–00534–4.
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practice has evolved over time, and if
so, how it has evolved, could aid in
identifying potential coding issues
related to this matter.
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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
re-nominated as potentially misvalued
based on the absence of separate direct
PE inputs for this 090 day global code
in the nonfacility setting. Currently,
CPT code 27279 is only priced under
the PFS in the facility setting, but the
nominator is requesting that we
establish separate direct PE inputs for
this service to value the service when
performed in the nonfacility/office
setting (for example, in an office-based
lab). The nominator stated that
establishing payment for direct PE
inputs in the nonfacility/office setting
would increase access to this service for
Medicare patients.
We did not nominate CPT code 27279
as potentially misvalued in the CY 2024
PFS final rule, mainly due to a lack of
consensus on whether these services
may be safely and effectively furnished
in the nonfacility/office setting. In this
year’s submission, the nominator
provided three post-market surveillance
publications and two independent
reviews of minimally invasive sacroiliac
(SI) joint fusion procedures to support
their assertion that this 90-day surgical
service could be safely and effectively
furnished in the nonfacility/office
setting. Based on the studies, the
nominator stated that the current
medical literature provides evidence
supporting the conclusion that
percutaneous or minimally invasive SI
joint arthrodesis (CPT code 27279)
carries a complication rate that is
acceptably low, comparable to other
spinal procedures commonly performed
in the office-based lab (OBL). For
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instance, the risk of major complications
during lateral trans iliac (LTI) SI joint
fusion (CPT code 27279) is lower than
the risks associated with other OBL
procedures. These include the risk of
iliac perforation during angioplasty, the
risk of death, myocardial infarction
(MI), and stroke during diagnostic
cardiac catheterization. The nominator
did not reference literature regarding the
rates of major complications for other
OBL procedures in their submission.
Based on the information submitted
we recognize the possibility that CPT
code 27279 may be potentially
misvalued, given the nominator’s
assertion that its complication rate is
acceptably low based on the five studies
they submitted. The results of the
studies may suggest that CPT code
27279 can be safely performed in the
office-based lab setting, as asserted by
the nominator, with a relatively low
complication rate. However, upon
reviewing the submitted information,
we also note that these studies
collectively report heterogeneous safety
outcomes. The large variabilities in
safety outcomes reported in the studies,
coupled with several unreported
outcomes, may indicate that we have
little knowledge about the effect of the
service on safety outcomes, prompting
the need for further investigation.
Therefore, we are not proposing to
consider this code as potentially
misvalued, and we are instead seeking
comments and additional studies from
the broader medical community
regarding whether this code should be
priced under the PFS for the nonfacility/office setting.
(3) CPT code 95800
An interested party re-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) to update practice
expenses that were last reviewed in
2017. This code was nominated as
potentially misvalued in the CY 2024
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PFS proposed rule (88 FR 52283). For
the CY 2024 final rule, we stated that we
were unable to properly assess whether
CPT code 95800 is potentially
misvalued based on the evidence
submitted with the original nominations
and subsequent comments that CMS
received (88 FR 78849–78850). This
year, an interested party re-nominated
CPT code 59800 noting two significant
changes: (1) in the technologies
available to perform home sleep apnea
testing (HSAT) services; and (2) in
clinical practice that leads to the typical
procedure reported with the CPT code
95800. According to the nominator, the
current practice utilizes disposable
HSAT technology, such as the WatchPat
One device, more often than the
reusable equipment currently included
in the procedure’s direct practice
expense (PE) inputs.
To account for these changes, the
nominator requested the deletion of
three direct PE input codes: (1)
equipment code EQ335 (WatchPAT 200
Unit with strap, cables, charger, booklet,
and patient video); (2) equipment code
EQ336 (Oximetry and Airflow Device);
and (3) supply code SD263 (WatchPAT
pneumo-opt sleep probes), which are
WatchPAT probes used with the
reusable WatchPAT unit. Instead, the
nominator requested the addition of a
supply code SD362 (the WatchPAT ONE
device), a disposable HSAT technology,
as a replacement. According to our PE
supply list, the combined price of the
items that the nominator requested to
delete (EQ335, EQ336, and SD263) is
$4.71 + $4.55 + $73.32 = $82.58, which
is $15.62 less than the price of the item
that the nominator requested to add
(SD362), priced at $98.20. The price of
$98.20 is mentioned in the nomination
letter without an accompanying specific
invoice. Last year, the nominator
submitted invoices, showing a price of
$99.00 each (a case of 12 totaling
$1,188.00) for the WatchPat One Device
(SD362) (see Table 6).
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EQ336
SD263
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SD362
WatchPAT 200 Unit with strap,
cables, charger, booklet and
atient video
Oximetry and Airflow Device
WatchPAT pneumo-opt slp
robes reusable
WatchPAT ONE device
dis osable
The nominator asserted that testing
trends have shifted away from
traditional airflow-based tests, with a
noticeable rise in peripheral arterial
tone (PAT)-based (non-airflow) tests.
The traditional airflow-based tests use
the reusable supplies and equipment,
whereas the PAT-based non-airflow
tests use the disposable HSAT device.
While describing these changes in
trends, the nominator did not provide
us with their internal data, thus we are
unable to verify its validity. The
nominator also stated that disposable
HSAT devices were used for nearly 50
percent of CPT code 95800 services in
2023 and attributed the increased use of
disposable devices to the COVID–19
public health emergency (PHE).
Furthermore, the nominator projected
that over 50 percent of CPT code 95800
services will be furnished using
disposable devices in 2024 and 2025.
Explaining the patterns and predictions,
the nominator concluded that the
pandemic significantly altered the
delivery of HSAT services, with many
sleep physicians transitioning to singleuse, disposable sleep tests as an
alternative to the reusable testing
equipment that is shipped from patientto-patient after post-use cleaning. The
nominator believes that, going forward,
the typical procedure described by CPT
code 95800 in CY 2024 and beyond will
be furnished using disposable HSAT
devices rather than reusable equipment.
Since the COVID–19 PHE ended in
2023, we are still unclear as to whether
the typical procedure reported with CPT
code 95800 involves the use of a
reusable or disposable HSAT device.
Given that we only have access to the
nominator’s summary of their internal
data to observe changes in usage trends,
which may not be generalizable, we
propose to maintain the current direct
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$4.55
Delete
$73.32
Delete
$98.20
Add
PE supply and equipment inputs for
CPT code 95800. While we are not
currently proposing to review CPT code
95800 as potentially misvalued for CY
2025, we seek public comments on this
nomination. In particular, we seek
comments on whether the typical
procedure described by CPT code 95800
now involves the use of a disposable
HSAT device rather than reusable
equipment.
(4) CPT codes 10021, 10004, 10005,
10006
An interested party nominated the
CPT code 10021 (Fine needle aspiration
biopsy, without imaging guidance; first
lesion), CPT code 10004 (Fine needle
aspiration biopsy, without imaging
guidance; each additional lesion), CPT
code 10005 (Fine needle aspiration
biopsy, including ultrasound guidance;
first lesion) and CPT code 10006 (Fine
needle aspiration biopsy, including
ultrasound guidance; each additional
lesion) as potentially misvalued. We
note that this code family has been
nominated several times in recent years.
We discussed our review of these codes
and our rationale for finalizing the
current values extensively in the CY
2019 PFS final rule (83 FR 59517), and
CY 2021 PFS final rule (85 FR 84602).
Furthermore, this code family was
nominated as potentially misvalued and
discussed in the CY 2020 PFS final rule
(84 FR 62625). For more information we
encourage the interested parties to go to
our previous PFS final rules.
The nominator specifically requested
that we revisit our work RVU decisions
for these codes, stating that the
underpinnings of the reduction in work
RVUs from the RUC-recommended
values were flawed. The nominator
suggested that CMS should adopt the
RUC-recommended work RVUs. For
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CPT code 10021, the RUC recommended
a work RVU of 1.20, but we adopted a
lower value of 1.03. Similarly, for CPT
code 10005, the RUC recommended a
work RVU of 1.63, but we adopted 1.46.
The nominator disagreed with these
reductions from the RUC-recommended
values by CMS, raising particular
concerns about our choice for the RVU
crosswalk for CPT code 36440 (Push
blood transfusion, patient 2 years or
younger). According to the nominator,
the CPT code we chose is not
comparable to fine needle aspiration in
any respect other than service time. The
nominator raised several points,
including that CPT code 36440 is rarely
utilized and is almost never billed to
Medicare because it pertains to a
pediatric procedure conducted on
neonates, while CPT code 10021 is
never performed on neonates. They
further asserted that the training and
experience levels required to properly
perform these procedures differ
significantly; neonatal transfusions can
be conducted by less experienced
personnel, while performing a thyroid
fine needle aspiration demands more
experience. Specifically, they argued
that there is a notable difference in the
work intensity between the two
procedures. The thyroid is closely
positioned to vital structures such as the
carotid artery, jugular vein, lymphatic
vessels, nerves, trachea, and esophagus.
When sampling thyroid nodules, they
are often in proximity to the carotid
artery, jugular vein, or both. According
to the nominator, even a slight deviation
of 1–2 millimeters during the sampling
procedure can result in accidental
puncture of these critical blood vessels
or other nearby structures. Factors such
as respiratory movements, patient
swallowing, or anxiety may cause the
thyroid to move, further increasing the
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TABLE 6: Listing of Nominator's Practice Expense items for addition or deletion to CPT
code 95800
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risk during the procedure. In contrast,
neonatal phlebotomy does not require
such measures. Also, the CPT code
36440 is designated as facility-only,
meaning it does not include any clinical
staff pre-service time and has no
associated practice expense inputs.
According to the nominator, fine needle
aspiration is a very complex and highrisk procedure that may require
significant physician work and a higher
level of clinical expertise to furnish the
service, which is very different from
CPT code 36440. We appreciated the
survey (N=74) results that the nominator
submitted to support their statements.
The nominator-conducted survey, and
their survey questions aimed to gather
information on the practitioners’
experiences, opinions, and practices
related to fine needle aspiration
procedures. However, no other
references such as peer reviewed
medical literature or other nationally
representative survey data were
provided to reinforce their argument.
The nominator further stated that
thyroid fine needle aspiration should
exclusively be performed as an
outpatient procedure and does not
require hospitalization. The nominator
emphasized that the reduction in
payment for the code family due to the
reduction in work RVUs from the RUCrecommended values has led
endocrinologists in office-based
practices, those who are not affiliated
with facilities, to discontinue furnishing
this service. According to the
nominator, as a consequence of this
payment decrease, patients are now
being referred to hospital-based
radiology practices, despite the fact that
thyroid fine needle aspiration should
ideally be conducted exclusively in
nonfacility outpatient settings. The
nominator asserted that radiologists in
hospital settings are often unfamiliar
with the patient’s medical history and
risk factors for suspected thyroid cancer.
The nominator further noted that
radiologists’ training in thyroid cancer
primarily emphasizes imaging and
procedures, rather than considering the
patient’s overall health perspective.
This result may further lead to an
increase in medically unnecessary
procedures. Additionally, the nominator
believes that the payment reduction for
this code family has the potential to
diminish the specialist workforce
trained to perform these procedures,
thereby presenting future challenges in
patient care and access to specialized
services.
Overall, we appreciate the
comprehensive information and level of
detail provided by the nominator. The
nominator disagreed with the choice of
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crosswalk CPT code 36440 made by
CMS, emphasizing the differences in
provider training, procedure risk, and
patient population. They noted the
rarity of Medicare billing for this code.
Additionally, they emphasized the
importance of outpatient thyroid fine
needle aspiration being performed by
endocrinologists. The shift to facility
settings, prompted by reduced work
RVUs, could raise Medicare costs. This,
along with a potential decline in
specialist workforce, may hinder patient
access. However, in discussing this
group of codes, we must note that these
codes have been recently reviewed
multiple times through the annual PFS
rulemaking process. We would like to
clarify once again that we disagree with
the nominator that this code family is
potentially misvalued. We acknowledge
the possibility that there could be
significant changes in the practice of
delivering services described by these
codes that were not fully reflected in the
current work RVU. In such cases, it
would be appropriate to refer the codes
to the RUC to conduct a new survey to
capture these changes accurately.
However, we note that these codes
underwent thorough RUC survey and
review processes during the October
2017 and January 2018 RUC meetings.
Based on these considerations, we
disagree with the assertion that this
code family is potentially misvalued.
Nevertheless, we welcome comments on
whether these codes should be rereviewed in light of the arguments made
by the nominator.
(5) Tympanostomy codes
CMS routinely interacts with
interested parties, and in our most
recent review, we have observed several
new devices that could be beneficial for
populations but are not currently
included in our coding system. While
there are variations in the described
devices, they commonly share the
following descriptions. This device uses
an innovative surgical technology that
combines the separate functions of
creating a myringotomy (incision in the
eardrum), and positioning and placing a
ventilation tube across the tympanic
membrane. The new device is intended
to deliver a tympanostomy tube (also
referred to as a ventilation tube) through
the tympanic membrane of the patient
and is indicated to be used in office
settings for pediatric patients 6 months
and older. This device allows the
tympanostomy service to be furnished
to patients without general anesthesia
and the service could therefore be
performed in the office setting.
Regarding the delivery of this service
using innovative surgical technology,
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CMS recognizes that CPT code 69433
(Tympanostomy (requiring insertion of
ventilating tube), local or topical
anesthesia) (010-day global code) may
serve as a sufficient base code,
adequately describing the majority of
the surgeon’s work and facility
resources. However, a practitioner may
incur additional resources, due to the
higher expected intraservice work
driven by both time and intensity
factors, especially when furnishing a
service to a child, and the cost of the
device when using these devices as part
of the performed procedure. While the
existing CPT code 69433 is not agespecific, both the vignette and the RVU
associated with this procedure are
established for adult patients who can
respond to surgeon direction, and do
not have risk of movement during the
procedure. We believe that potentially
establishing additional coding and
payment for tympanostomy services
may enable the provision of these
services utilizing new technologies to a
broader patient population who may
benefit from innovative surgical
technology. To improve the accuracy of
the payment for these services, we are
soliciting comments on several
alternatives that we are considering for
adoption in the CY 2025 PFS final rule
or future rulemaking. First, we are
seeking comment on whether to
establish a new G code that accounts for
the work and practice expense for a
procedure involving the positioning and
placement of a ventilation tube across
the tympanic membrane using an
innovative surgical technology that
combines the separate functions of
creating a myringotomy (incision in the
eardrum). We could assign contractor
pricing to this potential G code for
generalizable innovative tympanostomy
tube delivery devices and/or systems
falling under emerging technology and
services categories. Alternatively, we are
seeking comment on whether we should
establish an add-on payment for the
service using inputs from CPT code
69433 as a crosswalk reference, plus
direct costs from invoices for the
surgical devices referenced above. We
are seeking comments regarding these
potential approaches, particularly on
whether there is additional information
we should consider if we were to
establish additional coding and
payment for these services.
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
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further details and full discussion of the
scope of Medicare telehealth services in
the CY 2018 PFS final rule (82 FR
53006), the CY 2021 PFS final rule (85
FR 84502) and the CY 2024 PFS final
rule (88 FR 78861 through 78866) and
in 42 CFR 410.78 and 414.65. For a
discussion of Telemedicine Evaluation
and Management (E/M) Services, we
refer readers to section II.E.4.18 of this
proposed rule.
1. Payment for Medicare Telehealth
Services Under Section 1834(m) of the
Act
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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. 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. Under the
process we established beginning in CY
2003, we evaluated whether a service
meets the following criteria:
• Category 1: Services similar to
professional consultations, office visits,
and office psychiatry services currently
on the Medicare Telehealth Services
List. In reviewing these requests, we
looked 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 was present with the
beneficiary in the originating site. We
also looked 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 included assessing
whether the service was accurately
described by the corresponding code
when furnished via telehealth and
whether using a telecommunications
system to furnish the service produces
demonstrated clinical benefit to the
patient. Submitted evidence should
have included both a description of
relevant clinical studies that
demonstrated the service furnished by
telehealth to a Medicare beneficiary
improves the diagnosis or treatment of
an illness or injury or improves the
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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
did not include minor or incidental
benefits. Some examples of other
clinical benefits that we considered
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.
In the CY 2021 PFS final rule (85 FR
84507), we created a third category of
criteria for adding services to the
Medicare Telehealth Services List on a
temporary basis following the end of the
PHE for the COVID–19 pandemic. This
new category described services that
were added to the Medicare Telehealth
Services List during the PHE, for which
there was likely to be clinical benefit
when furnished via telehealth, but there
was 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 ultimately
needed 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 would
conduct a clinical assessment to identify
those services for which we could
foresee a reasonable potential likelihood
of clinical benefit when furnished via
telehealth.
In the CY 2024 PFS final rule (88 FR
78861 through 78866), we consolidated
these three categories and implemented
a revised 5-step process for making
additions, deletions, and changes to the
Medicare Telehealth Services List (5step process), beginning for the CY 2025
Medicare Telehealth Services List.
Rather than categorizing a service as
‘‘Category 1’’ or ‘‘Category 2,’’ each
service is now assigned a ‘‘permanent’’
or ‘‘provisional’’ status. As described
further below, a service is assigned a
‘‘provisional’’ status if there is not
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61621
enough evidence to demonstrate that the
service is of clinical benefit, but there is
enough evidence to suggest that further
study may demonstrate such benefit.
The 5-step process review criteria are
set forth in the CY 2024 PFS final rule
(88 FR 78861 through 78866), listed at
https://www.cms.gov/medicare/
coverage/telehealth/criteria-request, and
summarized below. Consistent with the
deadline for our receipt of code
valuation recommendations from the
American Medical Association’s
Relative Value Scale Update Committee
(AMA RUC) and other interested parties
(83 FR 59491) and with the process set
forth in prior calendar years, for CY
2025, requests to add services to the
Medicare Telehealth Services List must
have been submitted to and received by
CMS by February 10, 2024. 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 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 to
add services to the Medicare Telehealth
Services List, including where to send
these requests, and to view the current
Medicare Telehealth Service List, see
our website at https://www.cms.gov/
Medicare/Medicare-GeneralInformation/Telehealth/.
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 first determine whether the
service, as described by the individual
HCPCS code, is separately payable
under the PFS because, as further
discussed in CY 2024 PFS final rule (88
FR 78861 through 78866), Medicare
telehealth services are limited to those
services for which separate Medicare
payments can be made under the PFS.
Before gathering evidence and preparing
to submit a request to add a service to
the Medicare Telehealth Services List,
the submitter should therefore 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).
Step 2. Determine whether the service
is subject to the provisions of section
1834(m) of the Act.
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If we determine at Step 1 that a
service is separately payable under the
PFS, we apply Step 2 under which we
determine whether the service at issue
is subject to the provisions of section
1834(m) of the Act. Section 1834(m) of
the Act provides for payment to a
physician (or other 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 have
historically interpreted this to mean that
only services that are ordinarily
furnished with the furnishing
practitioner and patient in the same
location can be classified as a
‘‘telehealth service’’ for which payment
can be made under section 1834(m) of
the Act. Given that there may be a range
of services delivered using certain
telecommunications technology that,
though they are separately payable
under the PFS, do not fall within the
definition of telehealth service set forth
in section 1834(m) of the Act, the aim
of Step 2 is therefore to determine
whether the service at issue is, in whole
or in part, inherently a face-to-face
service. 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 therefore review
during this Step 2 whether one or more
of the elements of the service, as
described by the particular HCPCS code
at issue, ordinarily involve direct, faceto-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.
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).
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Step 3 is corollary to Step 2, and is
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 requesters 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
clinical actions, or patient interaction,
would not be of similar content as an inperson visit, or could not be completed.
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 Step 4 is to simplify
and reduce the administrative burden of
submission and review. For Step 4, we
review 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 is assigned
permanent status. Any code that
satisfies this criterion would require no
further analysis. If the service elements
of a code maps to the service elements
of a code that is already included on the
Medicare Telehealth Services List and is
assigned permanent basis, we will add
the code to the Medicare Telehealth
Services List and assign it permanent
status. While we have not previously
found that the service elements of a
code we are considering for addition to
the list map to the elements of a service
that was previously added to the list
and assigned permanent basis, we
believe that it is 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. When Step 4 is met, further
evidence review is not necessary. We
continue to Step 5 if Step 4 is not met.
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
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simplify and reduce the administrative
burden. Under Step 5, we review the
evidence provided with a submission to
determine the clinical benefit of a
service. We 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. If there is enough evidence to
suggest that further study may
demonstrate that the service, when
provided via telehealth, is of clinical
benefit, CMS will 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
will 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 reminded readers that our
evidentiary standard of demonstrated
clinical benefit does not include minor
or incidental benefits (81 FR 80194). We
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. General evidence may also
answer the question of whether a certain
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
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reflecting practitioner services furnished
to Medicare beneficiaries are helpful in
our considerations.
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b. Requests To Add Services to the
Medicare Telehealth Services List for
CY 2025
Medicare Telehealth Services List,
effective for CY 2025. The requested
services are listed in Table 7.
We received several requests to
permanently add various services to the
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TABLE 7: CY 2025 Requests for Permanent Addition to the Medicare Telehealth Services
List
Radiation
Treatment
M t
Intensive
Cardiac Rehab
Developmental
Tcstin
Health and Well
Being Coaching
77427
Radiation tx management x5
96130
96136
96137
G0422
G0423
96112
96113
0591T
0592T
p
p
1st
p
lntens cardiac rehab w/exerc
no exer
lntens
Devel
t hr
Devel
Hlth&
Outpatient
Pulmonary
Rehab
Cardiac Rehab
BILLING CODE C
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Physical
Thernpy
97162
97163
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Diagnostic CI
Testing
(1) Continuous Glucose Monitoring
We received a request to add CPT
code 95251 (Ambulatory continuous
glucose monitoring of interstitial tissue
fluid via a subcutaneous sensor for a
minimum of 72 hours; analysis,
interpretation and report) to the
Medicare Telehealth Services List and
assign it permanent status. This code is
not on the Medicare Telehealth Services
List, nor had it been previously added
and removed. The requester stated that
the ability of the practitioner to interpret
continuous glucose monitoring data and
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communicate changes in the diabetes
care plan to our patients is enhanced by
the availability of video visits, and the
code should therefore be added to the
Medicare Telehealth Services List. This
service does not meet the criteria
described by Step 2 of the 5-step
process: determination of whether the
service is subject to the provisions of
section 1834(m) of the Act. Section
1834(m) of the Act limits the definition
of Medicare telehealth services to those
services that would ordinarily be
furnished with the furnishing
practitioner and patient in the same
location (88 78863). In other words, as
stated above, for a service to be
considered a Medicare telehealth
service subject to and payable under
section 1834(m) of the Act, the service
must be so analogous to in-person care
such that the telehealth service, as
defined in § 410.78, is essentially a
substitute for a face-to-face encounter.
We do not consider this service a
Medicare telehealth service because it is
not an inherently face-to-face service;
the patient does not need to be present
for the service to be furnished in its
entirety. CPT code 95251 describes
sensor placement and monitoring over a
72-hour period. We do not consider CPT
code 95251 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.
(2) Cardiovascular and Pulmonary
Rehabilitation
We received requests to permanently
add cardiovascular rehabilitation
services (CPT codes 93797 and 93798)
and pulmonary rehabilitation services
(CPT codes 94625 and 94626) to the
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Medicare Telehealth Services List.
These services are currently on the
Medicare Telehealth List and are
assigned provisional status. We had
originally added CPT codes 93797 and
93798 and HCPCS codes G0422 and
G0423 on a temporary basis in the CY
2022 PFS final rule (FR 86 65054
through 65055). A requester cited
studies that they say demonstrate that
the availability of these services via
telehealth enhances access and patient
equity. Another requester cited evidence
of improved outcomes for patients that
had access to these services via
telehealth. As explained previously, we
are not proposing to revise the status of
codes from provisional to permanent in
this proposed rule because we intend to
conduct a comprehensive review. While
considering these issues for future
rulemaking, we are not proposing to
assign CPT codes 93797 and 93798 or
CPT codes 94625 and 94626 permanent
status on the Medicare Telehealth
Services List and would instead
maintain the services on the Medicare
Telehealth Services List on a
provisional basis for CY 2025.
(3) Health and Well Being-Coaching
We received a request to add Health
and Well-Being Coaching (CPT codes
0591T–0593T) to the Medicare
Telehealth Services List with permanent
status. These services are currently on
the Medicare Telehealth Services List
and are assigned a provisional status.
We originally added these codes on a
provisional basis in the CY 2024 PFS
final rule (FR 88 78859 and 78860). One
requester stated that health and wellbeing coaching, including content
education, delivered in a telehealth
modality is an evidence-based, cost-
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Many services were added to the
Medicare Telehealth Services List on a
temporary basis as discussed in the
March 31st COVID–19 interim final rule
with comment period (IFC) (85 FR
19235 through 19237) for the PHE for
Covid-19, and we subsequently retained
these services on a provisional basis. All
of the received submissions were
requests for addition on a permanent
basis. We believe that, rather than
selectively adjudicating only those
services for which we received requests
for potential permanent status, it would
be appropriate to complete a
comprehensive analysis of all
provisional codes currently on the
Medicare Telehealth Services List before
determining which codes should be
made permanent. We are therefore not
making determinations to recategorize
provisional codes as permanent until
such time as CMS can complete a
comprehensive analysis of all such
provisional codes which we expect to
address in future rulemaking.
The following is a discussion of the
requests received for addition of
services to the Medicare Telehealth
Services List:
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effective, sustainable, and common
sense approach to facilitating lifestyle/
behavioral intervention and treating the
Medicare population with or at
heightened risk for chronic diseases. As
explained previously, we are not
proposing to revise the status of codes
from provisional to permanent in this
proposed rule because we intend to
conduct a comprehensive review.
Therefore, we are not proposing to
assign them to the Medicare Telehealth
Services List with permanent status.
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(4) Psychological Testing and
Developmental Testing
We received a request to add
Psychological Testing and
Developmental Testing (CPT codes
96112, 96113, 96130, 96136, and 96137)
to the Medicare Telehealth Services List
on a permanent basis. These services are
currently on the Medicare Telehealth
Services List and are assigned
provisional status. In the March 31,
2020 interim final rule with comment
period (IFC–1) (85 FR 19239), we
originally added CPT codes 96130,
96136, and 96137 to the Medicare
Telehealth Services List for the duration
of the PHE for COVID–19, and in the CY
2021 PFS final rule (85 FR 85003), we
stated we were retaining them on the
list on a category 3 basis. In the CY 2023
PFS final rule (87 FR 69460), we added
CPT codes 96112 and 96113 on a
temporary basis.
As explained previously, we are not
proposing to revise the status of codes
from provisional to permanent in this
proposed rule because we intend to
conduct a comprehensive review.
Therefore, we are not proposing to
either remove these services from or to
assign them permanent status on the
Medicare Telehealth Services List.
(5) Therapy/Audiology/Speech
Language Pathology
We received multiple requests to add
the Therapy services described by CPT
codes 97110, 97112, 97116, 97161
through 97164, 97530 and 97535, 97165
through 97168, and Audiology and
Speech Language Pathology services
CPT codes 92507, 92508, 92521 through
92524, 92526, 92607 through 92610,
96105 92626, 92627, 96125, 97129,
97130, 92607 through 92609 92550
through 92557, 92563, 92565 92567,
92568, 92570, 92587, 92588, 92601
through 92604, 92625 through 92627,
and 92651 and 92652 to the Medicare
Telehealth Services List on a permanent
basis stating that continuing Telehealth
flexibilities for these services could lead
to reduced health care expenditures,
increased patient access, and improved
management of chronic disease and
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quality of life. These services are
currently available on the Medicare
Telehealth Services List and are
assigned provisional status, and we refer
readers to section II.D.1. for further
discussion of these services. In the CY
2023 PFS final rule (87 FR 69451), we
originally added CPT codes 90901,
97150, 97530, 97537, 97542, 97763, and
98960–98962 to the Medicare
Telehealth Services List on a Category 3
basis. As explained previously, we are
not proposing to revise the status of
codes from provisional to permanent in
this proposed rule because we intend to
conduct a comprehensive review.
Therefore, we are not proposing to
assign them permanent status on the
Medicare Telehealth Services List.
(6) Care Management
We received a request to permanently
add General Behavioral Health
Integration (CPT code 99484) and
Principal Care Management (CPT codes
99424–99427) to the Medicare
Telehealth Services List. These services
are not on the Medicare Telehealth
Services List, nor have they been
previously added and removed. These
services do not meet the criteria
described by Step 2 of the 5-step
process: determination of whether the
service is subject to the provisions of
section 1834(m) of the Act. As stated
above, 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 (88 78863), and for a
service to be considered a telehealth
service subject to and payable under
section 1834(m) of the Act, the service
must be so analogous to in-person care
such that the telehealth service, as
defined in § 410.78, is essentially a
substitute for a face-to-face encounter.
We do not consider these services to be
Medicare telehealth services because
they are not inherently face-to-face
services, and the patient need not be
present for the services to be furnished
in its entirety. Therefore, we do not
consider CPT codes 99484 and 99424–
99427 to be telehealth services 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.
(7) Posterior Tibial Nerve Stimulation
for Voiding Dysfunction
We received a request to permanently
add Posterior tibial neurostimulation
(CPT code 64566) to the Medicare
Telehealth Services List. This code is
not on the Medicare Telehealth Services
List, nor had it been previously added
and removed. This service does not
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meet the criteria for addition described
by Step 3 of the 5-step process, namely
the 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). The
requestor describes the services
underlying CPT code 64566 as the
continual or recurring treatments over a
period of time consisting of the remote
monitoring of device utilization and
bladder diary for the generation of
reports for review by the care provider.
Based on our review, this description
does not align with the elements of the
service as described by CPT code 64566.
CPT code 64566 describes a single
treatment provided by a clinician who
has direct contact with the patient and
inserts an electrode into the skin
overlying the posterior tibial nerve.
Upon conclusion of the treatment, the
clinician removes the electrode and
examines and dresses the puncture
wound. Providing these services would
require in-person interaction. We are
therefore not proposing to add the
service to the Medicare Telehealth
Services List because we do not believe
the service elements can be met in full
using two-way audio-video
telecommunications technology.
(8) Radiation Treatment Management
We received requests to permanently
add Radiation Treatment Management
(CPT code 77427) to the Medicare
Telehealth Services List. The code is
currently on the Medicare Telehealth
List with provisional status. In the
March 31, 2020 IFC (85 FR 9240), we
originally added CPT code 77427 on the
Medicare Telehealth Services List for
the duration of the PHE for Covid–19. A
requester stated that data collected
during the PHE demonstrates that the
telehealth option is as safe as the inperson equivalent. We also received a
request that we remove this code from
the Medicare Telehealth Services List,
citing the importance of in-person
physical examination to ensure quality
of care and stating that a telehealth
modality presents patient safety
concerns such as those related to the
ability of the practitioner to address side
effects of radiation therapy. Given the
safety concerns raised by members of
the practitioner community, we believe
this service may not be safely and
effectively furnished, and therefore
believe that such concerns merit
removing this item from the telehealth
list. We are therefore proposing to
remove this code from the Medicare
Telehealth Services List, and we are
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soliciting comment on these quality of
care concerns.
(9) Home International Normalized
Ratio (INR) Monitoring
We received a request to permanently
add Home INR Monitoring (HCPCS code
G0248) to the Medicare Telehealth
Services List. This service is not on the
Medicare Telehealth Services List, nor
had it been previously added and
removed. We are proposing to add
HCPS code G0248 to the Medicare
Telehealth Services List with provision
status because our clinical analyses of
these services indicate that they can be
furnished in full using two-way, audio
and video technology, and information
provided by requesters indicates that
there may be clinical benefit; however,
there is not yet sufficient evidence
available to consider the services for
permanent status. This service as
described by the HCPCS code describes
face-to-face demonstration of use and
care of the INR monitor, obtaining at
least one blood sample, provision of
instructions for reporting home INR test
results, and documentation of patient’s
ability to perform testing and report
results, and we believe each of these
service elements the elements is capable
of being furnished using an interactive
telecommunications system. Adding
this service on a provisional basis will
allow additional time for the
development of evidence of clinical
benefit when this service is furnished
via telehealth for CMS to consider when
evaluating this service for potential
permanent addition to the Medicare
Telehealth Services List.
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(10) Caregiver Training
We received a request to permanently
add Caregiver Training services, as
described by HCPCS codes 97550
(Caregiver training in strategies and
techniques to facilitate the patient’s
functional performance in the home or
community (eg, 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 CPT code 97551 (Caregiver training
in strategies and techniques to facilitate
the patient’s functional performance in
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the home or community (eg, activities of
daily living [ADLs], instrumental ADLs
[iADLs], transfers, mobility,
communication, swallowing, feeding,
problem solving, safety practices)
(without the patient present), face to
face; each additional 15 minutes (List
separately in addition to code for
primary service)) to the Medicare
Telehealth Services List. These codes do
not currently appear on the Medicare
Telehealth Services List nor had they
previously been added or removed. We
are proposing to add these services to
the Medicare Telehealth List with
provisional status for CY 2025, in
addition to the other currently payable
caregiver training service codes (CPT
codes 97550, 97551, 97552, 96202,
96203). These codes are new services
that were added to the PFS beginning in
2024. Given the limited utilization of
those codes added for 2024, there are
not peer-reviewed studies supporting
these codes’ ability to be furnished
remotely. Adding these services on a
provisional basis will allow additional
time for the development of evidence of
clinical benefit when these services are
furnished via telehealth for CMS to
consider when evaluating these services
for potential permanent addition to the
Medicare Telehealth Services List.
Contingent upon finalizing the service
code descriptions that we propose in
section II.E. of this proposed rule, we
also propose that HCPCS code GCTD1–
3 and GCTB1–2 be added to the
Medicare Telehealth Services list for CY
2025 on a provisional basis. We believe
that these codes are similar to other
services already available on the
Medicare Telehealth Services List,
including education and training for
patient self-management (CPT codes
98960–98962), self-care/home
management training (CPT codes
97535), and caregiver-focused health
risk assessment (CPT code 96161).
Further, it appears that all elements of
these services may be furnished when
using two-way interactive
communications technology. Adding
these services on a provisional basis
will allow additional time for the
development of evidence of clinical
benefit when this service is furnished
via telehealth for CMS to consider when
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61627
evaluating these services for potential
permanent addition to the Medicare
Telehealth Services List.
c. Other Services Proposed for Addition
to the Medicare Telehealth Services List
(1) Preexposure Prophylaxis (PrEP) of
Human Immunodeficiency Virus (HIV)
As discussed in Section II.E. of this
proposed rule, we are proposing
national rates for HCPCS codes G0011
(Individual counseling for pre-exposure
prophylaxis (PrEP) by physician or QHP
to prevent human immunodeficiency
virus (HIV), includes: HIV risk
assessment (initial or continued
assessment of risk), HIV risk reduction
and medication adherence, 15–30
minutes) and G0013 (Individual
counseling for pre-exposure prophylaxis
(PrEP) by clinical staff to prevent human
immunodeficiency virus (HIV),
includes: HIV risk assessment (initial or
continued assessment of risk), HIV risk
reduction and medication adherence)
pending the future finalization of the
NCD for Pre-Exposure Prophylaxis
(PrEP) for Human Immunodeficiency
Virus (HIV) Infection. We believe these
services are similar to services currently
on the Medicare Telehealth Services
list, specifically HCPCS codes G0445
(High intensity behavioral counseling to
prevent sexually transmitted infection;
face-to-face, individual, includes:
education, skills training and guidance
on how to change sexual behavior;
performed semi-annually, 30 minutes)
and 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) as these codes are the
codes from which HCPCS codes G0011
and G0013 were unbundled,
respectively. As similarity to services
currently on the Medicare telehealth list
is one of our criteria for permanent
addition, we are proposing to add
HCPCS codes G0011 and G0013 to the
Medicare Telehealth Services List with
a permanent status.
The services that we are proposing to
add to the Medicare Telehealth Services
List are listed in Table 8.
BILLING CODE P
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TABLE 8: Services Proposed for Addition to the Medicare Telehealth Services List for CY
2025
HCPCS
Lone: Descriotion
GOOll
PrEPfor
HIV
G0013
HomelNR
Monitoriill!
G0248
97550
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97551
Caregiver
Trainill!:
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Prooosed Status
Individual counseling for preexposure prophylaxis (PrEP) by
physician or QHP to prevent human
immunodeficiency virus (HIV),
includes: HIV risk assessment (initial
or continued assessment of risk), HIV
risk reduction and medication
adherence, 15-30 minutes
Individual counseling for preexposure prophylaxis (PrEP) by
clinical staff to prevent human
immunodeficiency virus (HIV),
includes: HIV risk assessment (initial
or continued assessment of risk), HIV
risk reduction and medication
adherence
Demonstration, prior to initiation of
home inr monitoring, for patient with
either mechanical heart valve(s),
chronic atrial fibrillation, or venous
thromboembolism who meets
medicare coverage criteria, under the
direction of a physician; includes:
face-to-face demonstration of use and
care of the inr monitor, obtaining at
least one blood sample, provision of
instructions for reporting home inr
test results, and documentation of
patient's ability to perform testing and
report results
Caregiver training in strategies and
techniques to facilitate the patient's
functional performance in the home
or community (cg, 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
Caregiver training in strategies and
techniques to facilitate the patient's
functional performance in the home
or community (eg, activities of daily
living LadlsJ, instrumental adls LiadlsJ,
transfers, mobility, communication,
swallowing, feeding, problem
solving, safety practices) (without the
patient present), face to face; each
additional 15 minutes (list separately
in addition to code for primary
service)
Group caregiver training in strategies
and techniques to facilitate the
patient's functional performance in
the home or communitv (eg, activities
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Permanent
Pennanent
Provisional
Provisional
Provisional
Provisional
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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
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HCPCS
Lone: Descriotion
96202
96203
GCTDl
GCTD2
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GCTBl
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Prooosed Status
Multiple-family group behavior
management/modification training for
parent(s)/guardian(s)/caregiver(s) of
patients wiU1 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
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 IS minutes (List
separately in addition to code for
primarv service)
Caregiver training in direct care
strategies and techniques to support
care for patients with an ongoing
condition or illness and to reduce
complications (without the patient
present), face-to-face; initial 30
minutes
Caregiver training in direct care
strategies and techniques to support
care for patients with an ongoing
condition or illness and to reduce
complications (without the patient
present), face-to-face; each additional
15 minutes (List separately in
addition to code for primacy service)
(Use GCTD2 in conjunction with
GCTDl)
Group caregiver training in direct
care strategies and techniques to
support care for patients with an
ongoing condition or illness and to
reduce complications (without the
patient present), face-to-face with
multiple sets of caregivers
Caregiver training in behavior
management/modification for
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; initial 30 minutes
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Provisional
Provisional
Provisional
Provisional
Provisional
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Caregiver training in behavior
management/modification 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; each additional
15 minutes (List separately in
addition to code for primary service)
(Use GCTB2 in conjunction with
GCTBl)
HCPCS
GCTB2
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BILLING CODE C
d. 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
frequency restrictions on how often
practitioners may furnish the service via
Medicare telehealth. These include a
limitation of one subsequent hospital
care service furnished through
telehealth every 3 days, added in the CY
2011 PFS final rule (75 FR 73317
through 73318), one subsequent nursing
facility visit furnished through
telehealth every 14 days, added in the
CY 2011 PFS final rule (75 FR73318),
and one critical care consultation
service furnished through telehealth per
day, added in the CY 2017 final rule (81
FR 80198). In establishing these limits,
we cited concerns regarding the
potential acuity and complexity of these
patients.
We temporarily removed these
frequency restrictions during the PHE
for COVID–19. In the March 31, 2020
COVID–19 interim final rule with
comment period (IFC) (85 FR 19241), we
stated that we did not believe the
frequency limitations for certain
subsequent inpatient visits, subsequent
NF visits, and critical care consultations
furnished via Medicare telehealth were
appropriate or necessary for the
duration of the PHE because this would
have been a patient population who
would have otherwise not had access to
clinically appropriate in-person
treatment. Although the frequency
limitations resumed effect on May 12,
2023 (upon expiration of the PHE),
through enforcement discretion during
the remainder of CY 2023 and noticeand-comment rulemaking for CY 2024,
Medicare telehealth frequency
limitations have been suspended for CY
2024 (88 FR 78876 through 78878) for
the following codes relating to
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Subsequent Inpatient Visits, Subsequent
Nursing Facility Visits, and Critical Care
Consultation Services:
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
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
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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
CY 2025.
In the CY 2024 PFS final rule (88 FR
78877), we solicited comments 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.
As discussed in that final rule, many
commenters supported permanently
removing these frequency limitations,
stating that they are arbitrary and reimposing the limitations would result in
decreased access to care; that
practitioners should be allowed to use
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their clinical judgment to determine the
type of visit, how many visits, and the
type of treatment that is the best fit for
the patient so long as the standard of
care is met; and that lifting these
limitations during the PHE has been
instructive and demonstrates the value
of continuing such flexibilities. Many
commenters urged us to permanently
remove them. That said, some
commenters did not support removing
these frequency limitations citing
patient acuity and safety, some
commenters cited the importance of inperson care for patients in acute care
settings. Some commenters stated that
telehealth patient assessments and
evaluations are never the same as inperson, hands on visits and should not
be considered a viable replacement with
no limitations for in-person care. We are
continuing to consider what changes we
should be making to how telehealth
services are reimbursed under Medicare
in light of the way practice patterns may
have changed following the PHE for
COVID–19. Taking into account the
information received from commenters
in the CY 2024 PFS final rule, we
believe it is reasonable to continue to
pause certain pre-pandemic restrictions,
such as the frequency limitations for the
abovementioned codes for CY 2025.
Removing such restrictions for CY 2025
will allow us to gather an additional
year of data to determine how practice
patterns are evolving and what changes,
if any, to frequency limitations should
be made. We do not believe pausing
such frequency limitations for another
year presents a level of safety risk
requiring us to immediately reinstate
the limitations. Our analysis of claims
data indicates that the volume of
services that would be affected by
implementing these limitations is
relatively low; in other words, these
services are not being furnished via
telehealth with such frequency that
frequency limits are being met or
exceeded very often or for many
beneficiaries (claims data from 2020—
2023 suggest that less than five percent
received one or more of these services
as a telehealth service). Therefore, while
claims data does not suggest that lifting
these limitations during the PHE has led
to an increase in utilization, we
continue to be interested in information
from interested parties on our concerns
regarding the potential acuity and
complexity of these patients and how
such acuity and complexity should
complexity should influence our
implementation of frequency
limitations.
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e. Audio-Only Communication
Technology To Meet the Definition of
‘‘Telecommunications System’’
Through our regulation at
§ 410.78(a)(3), we define ‘‘interactive
telecommunications system’’ as
multimedia communications equipment
that includes, at a minimum, audio and
video equipment permitting two-way,
real-time interactive communication
between the patient and distant site
physician or practitioner. Through
emergency regulations and waiver
authority under section 1135(b)(8) of the
Act, in response to the PHE for COVID–
19, we allowed the use of audio-only
communications technology to furnish
services described by the codes for
audio-only telephone evaluation and
management services and behavioral
health counseling and educational
services. Section 4113 of the CAA, 2023,
extended the availability of telehealth
services that can be furnished using
audio-only technology and provided for
the extension of other PHE-related
flexibilities including removal of the
geographic and location limitations
under section 1834(m) of the Act
through December 31, 2024.
In the CY 2022 PFS final rule (86 FR
65060), in part to recognize the changes
made by section 123 of the CAA, 2021
that removed the geographic restrictions
for Medicare telehealth services for the
diagnosis, evaluation, or treatment of a
mental health disorder and the addition
of the patient’s home as a permissible
originating site for these services, we
revisited our regulatory definition of
‘‘interactive telecommunications
system’’ beyond the circumstances of
the PHE. Specifically, we finalized a
policy to allow for audio-only services
under certain circumstances and revised
the regulation at § 410.78(a)(3) to permit
the use of audio-only equipment for
telehealth services furnished to
established patients in their homes for
purposes of diagnosis, evaluation, or
treatment of a mental health disorder
(including substance use disorders) if
the distant site physician or practitioner
is technically capable of using an
interactive telecommunications system
as defined previously, but the patient is
not capable of, or does not consent to,
the use of video technology. We also
established this policy in part because
mental health services are different from
most other services on the Medicare
telehealth services list in that many of
the services primarily involve verbal
conversation where visualization
between the patient and furnishing
physician or practitioner may be less
critical to the provision of the service.
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However, with the successive
statutory extensions of the telehealth
flexibilities implemented in response to
the PHE for COVID–19, most recently by
the CAA, 2023, and our adoption of
other extensions where we have had
authority to do so, we have come to
believe that it would be appropriate to
allow interactive audio-only
telecommunications technology when
any telehealth service is furnished to a
beneficiary in their home (when the
patient’s home is a permissible
originating site) and when the distant
site physician or practitioner is
technically capable of using an
interactive telecommunications system
as defined previously, but the patient is
not capable of, or does not consent to,
the use of video technology. While
practitioners should always use their
clinical judgment as to whether the use
of interactive audio-only technology is
sufficient to furnish a Medicare
telehealth service, we recognize that
there is variable broadband access in
patients’ homes, and that even when
technologically feasible, patients simply
may not always wish to engage with
their practitioner in their home using
interactive audio and video. Under
current statute, with the expiration of
the PHE-related telehealth flexibilities
on December 31, 2024, the patient’s
home is a permissible originating site
only for services for the diagnosis,
evaluation, or treatment of a mental
health or substance use disorder, and for
the monthly ESRD-related clinical
assessments described in section
1881(b)(3)(B) of the Act.
We are proposing to revise the
regulation at § 410.78(a)(3) to state that
an interactive telecommunications
system may also include two-way, realtime audio-only communication
technology for any telehealth service
furnished to a beneficiary in their home
if the distant site physician or
practitioner is technically capable of
using an interactive telecommunications
system as defined as multimedia
communications equipment that
includes, at a minimum, audio and
video equipment permitting two-way,
real-time interactive communication,
but the patient is not capable of, or does
not consent to, the use of video
technology. Additionally, a modifier
designated by CMS must be appended
to the claim for services described in
this paragraph to verify that these
conditions have been met. These are
CPT modifier ‘‘93’’ and, for RHCs and
FQHCs, Medicare modifier ‘‘FQ’’
(Medicare telehealth service was
furnished using audio-only
communication technology).
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Practitioners have the option to use the
‘‘FQ’’ or the ‘‘93’’ modifiers or both
where appropriate and true, since they
are identical in meaning.
f. Distant Site Requirements
In the CY 2024 PFS final rule (88 FR
78873 through 78874) we discussed that
many commenters expressed concerns
regarding the expiring flexibility for
telehealth practitioners to bill from their
currently enrolled location instead of
their home address when providing
telehealth services from their home.
CMS issued an FAQ, available at
https://www.cms.gov/files/document/
physicians-and-other-clinicians-cmsflexibilities-fight-covid-19.pdf, which
extended the flexibility for telehealth
practitioners to bill from their currently
enrolled location instead of their home
address when providing telehealth
services from their home through
December 31, 2023. Interested parties
suggested that the expiration of this
flexibility poses a potential and
imminent threat to the safety and
privacy of health professionals who
work from home and furnish telehealth
services. Commenters cited recent
examples of workplace violence in
health care facilities, where direct harm
to nurses and other medical staff
occurred. In addition to safety and
privacy concerns, interested parties
explained that a significant number of
practitioners would need to change their
billing practices or add their home
address to the Medicare enrollment file,
coordinating with the appropriate
Medicare Administrative Contractor in
their jurisdiction, and this would
present administrative burden. To
address these concerns, commenters
requested that CMS take steps to protect
telehealth practitioners by adjusting
enrollment requirements so that
individual practitioners do not have to
list their home addresses on enrollment
forms.
In response, CMS finalized, through
CY 2024, that we would continue to
permit a distant site practitioner to use
their currently enrolled practice
location instead of their home address
when providing telehealth services from
their home.
We have continued to hear from
interested parties who have stressed the
importance of continuing this flexibility
for the safety and privacy of health care
professionals. Given the shift in practice
patterns toward models of care that
include the practitioner’s home as the
distant site, we believe it would be
appropriate to continue this flexibility
as CMS considers various proposals that
may better protect the safety and
privacy of practitioners. We are
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therefore proposing that through CY
2025 we will continue to permit the
distant site practitioner to use their
currently enrolled practice location
instead of their home address when
providing telehealth services from their
home.
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
described under § 410.32 and services
incident to a physician’s (or other
practitioner’s) professional service
described under § 410.26 (incident-to
services), are required to be furnished
under specific minimum levels of
supervision by a physician or other
practitioner. We define three levels of
supervision in our regulation at
§ 410.32(b)(3): General Supervision,
Direct Supervision, and Personal
Supervision. Notwithstanding the
temporary measures implemented in
response to the PHE for COVID–19,
direct supervision requires the
physician (or other supervising
practitioner) to be present in the office
suite and immediately available to
furnish assistance and direction
throughout the performance of the
service. It does not mean that the
physician (or other supervising
practitioner) must be present in the
room when the service is performed.
Again, notwithstanding the temporary
measures implemented in response to
the PHE for COVID–19, 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)).
Direct supervision is required for
various types of services, including
most incident-to services under
§ 410.26, many diagnostic tests under
§ 410.32, pulmonary rehabilitation
services under § 410.47, cardiac
rehabilitation and intensive cardiac
rehabilitation services under § 410.49,
and certain hospital outpatient services
as provided under § 410.27(a)(1)(iv). In
the March 31, 2020 COVID–19 IFC, we
amended the definition of ‘‘direct
supervision’’ for the duration of the PHE
for COVID–19 (85 FR 19245 through
19246) at § 410.32(b)(3)(ii) to state that
the necessary presence of the physician
(or other practitioner) for direct
supervision includes virtual presence
through audio/video real-time
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communications technology. Instead of
requiring the supervising physician’s (or
other practitioner’s) physical presence,
the amendment permitted a supervising
physician (or other practitioner) to be
considered ‘‘immediately available’’
through virtual presence using two-way,
real-time audio/visual technology for
diagnostic tests, incident-to services,
pulmonary rehabilitation services, and
cardiac and intensive cardiac
rehabilitation services. We made similar
amendments at § 410.27(a)(1)(iv) to
specify that direct supervision for
certain hospital outpatient services may
include virtual presence through audio/
video real-time communications. The
CY 2021 PFS final rule (85 FR 84538
through 84540) and the CY 2024 PFS
final rule (88 FR 78878) subsequently
extended these policies through
December 31, 2024. As stated in the CY
2024 PFS final rule, we extended this
definition of direct supervision through
December 31, 2024, in order to align the
timeframe of the policy with other PHErelated telehealth policies that were
extended most recently under the
provisions of the CAA, 2023.
We note that in the CY 2021 PFS final
rule (85 FR 84539) we clarified 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 service. We
noted that this was the case during the
PHE and would continue to be the case
following the PHE. While flexibility to
provide direct supervision through
audio/video real-time communications
technology was adopted to be
responsive to critical needs during the
PHE for COVID–19 to ensure beneficiary
access to care, reduce exposure risk and
to increase the capacity of practitioners
and physicians to respond to COVID–
19, we expressed concern that direct
supervision through virtual presence
may not be sufficient to support PFS
payment on a permanent basis, beyond
the PHE for COVID–19, due to issues of
patient safety. For instance, in complex,
high-risk, surgical, interventional, or
endoscopic procedures, or anesthesia
procedures, a patient’s clinical status
can quickly change; in-person
supervision would be necessary for such
services to allow for rapid on-site
decision-making in the event of an
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adverse clinical situation. In addition to
soliciting comment in the CY 2021 PFS
proposed rule on whether there should
be any additional ‘‘guardrails’’ or
limitations to ensure patient safety/
clinical appropriateness, beyond typical
clinical standards, as well as restrictions
to prevent fraud or inappropriate use,
we solicited comment in the CY 2024
PFS proposed rule on whether we
should consider extending the
definition of direct supervision to
permit virtual presence beyond
December 31, 2024. Specifically, we
stated that we were interested in input
from interested parties on potential
patient safety or quality concerns when
direct supervision occurs virtually; for
instance, if direct supervision of certain
types of services with virtual presence
of the supervising practitioner 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 were also
interested in potential program integrity
concerns that interested parties may
have regarding this policy, such as
overutilization or fraud and abuse.
(1) Proposal To Extend Definition of
‘‘Direct Supervision’’ To Include AudioVideo Communications Technology
Through 2025
As discussed in the CY 2024 PFS final
rule (88 FR 78878), in the absence of
evidence that patient safety is
compromised by virtual direct
supervision, we are concerned about an
abrupt transition to our pre-PHE policy
that defines direct supervision to
require the physical presence of the
supervising practitioner. We noted 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 incident-to
services, and that physicians and/or
other supervising practitioners, in
certain instances, would 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. We
acknowledge the utilization of this
flexibility and recognize that many
practitioners have stressed the
importance of maintaining it, however
we seek additional information
regarding potential patient safety and
quality of care concerns. This flexibility
has been available and widely utilized
since the beginning of the PHE, and we
recognize that may enhance patient
access. However, given the importance
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of certain services being furnished
under direct supervision in ensuring
quality of care and patient safety, and in
particular the ability of the supervising
practitioner to intervene if
complications arise, we believe an
incremental approach is warranted,
particularly in instances where
unexpected or adverse events may arise
for procedures which may be riskier or
more intense. In light of these potential
safety and quality of care implications,
and exercising an abundance of caution,
we are extending this flexibility for all
services on a temporary basis only. We
are therefore proposing to 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, 2025.
(2) Proposal To Permanently Define
‘‘Direct Supervision’’ To Include AudioVideo Communications Technology for
a Subset of Services
In the CY 2024 PFS proposed rule, we
solicited comment on extending or
permanently establishing the virtual
presence flexibility for certain services
valued under the PFS given that these
services typically are performed in their
entirety by auxiliary personnel as
defined at § 410.26(a)(1). We stated such
services would include incident-to
services wholly furnished by auxiliary
personnel, Level I office or other
outpatient E/M visits for established
patients. We also mentioned Level I
Emergency Department (ED) visits in
this list, but have since concluded that
ED services would not be wholly
furnished by auxiliary personnel and,
for that reason, have excluded them
from the discussion in this proposed
rule. Based on our review, these specific
services present less of a patient safety
concern than services for which there
may be a need for immediate
intervention of the supervising
practitioner; as noted in the CY 2024
PFS proposed rule, allowing virtual
presence for direct supervision of these
services could 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. After
reviewing the various comments in
response to this solicitation, additional
feedback provided by interested parties,
and conducting our own independent
review, we believe these services are
low risk by their nature, do not often
demand in-person supervision, are
typically furnished entirely by the
supervised personnel, and allowing
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virtual presence for direct supervision
of these services would balance patient
safety concerns with the interest of
supporting access and preserving
workforce capacity.
We are proposing to adopt a
definition of direct supervision that
allows ‘‘immediate availability’’ of the
supervising practitioner using audio/
video real-time communications
technology (excluding audio-only), but
only for the following subset of
incident-to services described under
§ 410.26: (1) services furnished incident
to a physician or other practitioner’s
service when provided by auxiliary
personnel employed by the billing
practitioner and working under their
direct supervision, and for which the
underlying HCPCS code has been
assigned a PC/TC indicator of ‘5’; 10 and
(2) services described 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). As provided in the code
descriptor for CPT code 99211, an office
or other outpatient visit for the
evaluation and management of an
established patient may not require the
presence of a physician or other
practitioner and may be furnished
incident to a physicians’ service by a
nonphysician employee of the physician
under direct supervision. The service
described by CPT code 99211 and the
services that are identified with a PC/TC
indicator of ‘5’ as listed in the PFS
Relative Value Files are services that are
nearly always performed in entirety by
auxiliary personnel. The vignette for
CPT code 99211 describes the provision
of supervision and guidance to the
clinical staff as necessary. The code
descriptor for this service specifies an E/
M service that may not require the
presence of a physician or other
professional; and the current valuation,
which is relatively low compared to
other office and outpatient E/M services,
suggests that this service would
primarily be provided by auxiliary
personnel.
We are proposing an incremental
approach whereby we will adopt
without any time limitation the
definition of direct supervision
10 For a full list of all PFS payment status
indicators and descriptions, see the Medicare
Claims Processing Manual (IOM Pub. 100–04,
chapter 23, sections 30.2.2). For a full list of all PFS
payment status indicators and descriptions, see the
Medicare Claims Processing Manual (IOM Pub.
100–04, chapter 23, sections 30.2.2 and 50.6).
Specific indicators by service are listed in the PFS
Relative Value files at https://www.cms.gov/
medicare/payment/fee-schedules/physician/pfsrelative-value-files).
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permitting virtual presence for services
that are inherently lower risk: that is,
services that do not ordinarily require
the presence of the billing practitioner,
do not require direction by the
supervising practitioner to the same
degree as other services furnished under
direct supervision, and are not services
typically performed directly by the
supervising practitioner.
For all other services required to be
furnished under the direct supervision
of the supervising physician or other
practitioner, we are proposing, as
described above, to continue to define
‘‘immediate availability’’ to include
real-time audio and visual interactive
telecommunications technology only
through December 31, 2025.
We are proposing to revise the
regulations at § 410.32(b)(3)(ii) to state
that through December 31, 2025, the
presence of the physician (or other
practitioner) would include virtual
presence through audio/video real-time
communications technology (excluding
audio-only).
We are proposing to revise the
regulation at § 410.26(a)(2) to state that
for the following services furnished after
December 31, 2025, the presence of the
physician (or other practitioner)
required for direct supervision shall
continue to include virtual presence
through audio/video real-time
communications technology (excluding
audio-only): services furnished incident
to a physician’s service when they are
provided by auxiliary personnel
employed by the physician and working
under his or her direct supervision and
for which the underlying HCPCS code
has been assigned a PC/TC indicator of
‘5’; and office and other outpatient visits
for the evaluation and management of
an established patient that may not
require the presence of a physician or
other qualified health care professional.
(3) Teaching Physician Billing for
Services Involving Residents With
Virtual Presence
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
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 in increasing beneficiary access
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to Medicare-covered services in rural
areas. We 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, under 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. We refer readers to the CY 2021
PFS final rule (85 FR 84577 through
84584) for a more detailed description
of our specific concerns. 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 applied 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 expressed
concerns regarding the requirement that
the teaching physician be physically
present with the resident when a service
is furnished virtually (as a Medicare
telehealth service) within an MSA.
Some interested parties 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 stated that during
telehealth visits, the teaching physician
was virtually present during the key and
critical portions of the telehealth
service, available immediately in realtime, and had access to the electronic
health record. After review of the public
comments, we finalized a policy that
allowed the teaching physician to have
a virtual presence in all teaching
settings, only in clinical instances when
the service was furnished virtually (for
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61635
example, a 3-way telehealth visit, with
all parties in separate locations). This
permitted teaching physicians to have a
virtual presence during the key portion
of the Medicare telehealth service for
which payment was sought, through
audio/video real-time communications
technology, in all residency training
locations through December 31, 2024.
As stated in the CY 2024 PFS final
rule (88 FR 78880), we are concerned
that an abrupt transition to our pre-PHE
policy may present a barrier to access to
many services. We also understand that
teaching physicians have gained clinical
experience providing services involving
residents with virtual presence during
the PHE for COVID–19 and could help
us to identify circumstances where the
teaching physician can routinely
provide sufficient personal and
identifiable services to the patient
through their virtual presence during
the key portion of the Medicare
telehealth service. We sought comment
and information to help us consider
other clinical treatment situations where
it may be appropriate to continue to
permit the virtual presence of the
teaching physician, while continuing to
support patient safety, meeting the
clinical needs for all patients, and
ensuring burden reduction without
creating risks to patient care or
increasing opportunities for fraud. As
summarized in the CY 2024 PFS final
rule (88 FR 78881 through 78882),
commenters encouraged us to establish
this policy permanently and include inperson services to promote access to
care, stated that teaching physicians
should be allowed to determine when
their virtual presence would be
clinically appropriate, based on their
assessment of the patient’s needs and
the competency level of the resident.
While we continue to consider clinical
scenarios where it may be appropriate to
permit the virtual presence of the
teaching physician, we are proposing to
continue our current policy to allow
teaching physicians to have a virtual
presence for purposes of billing for
services furnished involving residents
in all teaching settings, but only when
the service is furnished virtually (for
example, a 3-way telehealth visit, with
the patient, resident, and teaching
physician 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 in
any residency training location through
December 31, 2025. The teaching
physician’s virtual presence would
continue to require real-time
observation (not mere availability) and
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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 Medicare telehealth
service, which includes documenting
the specific portion of the service for
which the teaching physician was
present through audio/video real-time
communications technology.
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(a) Request for Information for Teaching
Physician Services Furnished Under the
Primary Care Exception
The so-called primary care exception
set forth at § 415.174 permits the
teaching physician to bill for certain
lower and mid-level complexity
physicians’ services furnished by
residents in certain types of residency
training settings even when the teaching
physician is not present with the
resident during the services as long as
certain conditions are met, including
that the services are furnished by
residents with more than 6 months of
training in the approved residency
program; and that the teaching
physician directs the care of no more
than four residents at a time, remains
immediately available and has no other
responsibilities while directing the care,
assumes management responsibility for
beneficiaries seen by the residents,
ensures that the services furnished are
appropriate, and reviews certain
elements of the services with each
resident during or immediately after
each visit. For a more detailed
description of the list of services
currently allowed under the primary
care exception policy, we refer readers
to the CY 2021 PFS final rule (85 FR
84585 through 84590).
We have received feedback from
interested parties requesting that we
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permanently expand the list of services
that can be furnished under the primary
care exception to include all levels of E/
M services and additional preventive
services. These interested parties have
stated that the fact that high-value
primary care and preventive services are
not included in the scope of the primary
care exception discourages their
integration in residency training in
these primary care settings, which has a
negative impact on physician training,
patient access, and longer-term
outcomes. Additionally, these interested
parties have suggested that including all
levels of E/M services under the primary
care exception could support primary
care workforce development and
improve patient continuity of care
without compromising patient safety;
furthermore, including additional
preventive services within the primary
care exception would increase the
utilization of high-value services.
We believe the primary care exception
was intended to broaden opportunities
for teaching physicians to involve
residents in furnishing services under
circumstances that preserve the
direction of the care by the teaching
physician and promote safe, highquality patient care. As such, we are
requesting information to help us
consider whether and how best to
expand the array of services included
under the primary care exception in
future rulemaking. We are interested in
hearing more about the types of services
that could be allowed under the primary
care exception, specifically preventive
services, and whether the currently
required six months of training in an
approved program is sufficient for
residents to furnish these types of
services without the presence of a
teaching physician. We are seeking
comment to help us consider whether
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adding certain preventive services or
higher level E/M services to the primary
care exception would hinder the
teaching physician from maintaining
sufficient personal involvement in the
care to warrant PFS payment for the
services being furnished by up to four
residents at any given time. Similarly,
we are requesting information on
whether the inclusion in the primary
care exception of specific higher-level or
preventive services would impede the
teaching physician’s ability to remain
immediately available for up to four
residents at any given time, while
directing and managing the care
furnished by these residents.
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 2025
is 3.6 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 2025 based on historical
data through the second quarter of 2024.
Therefore, for CY 2025, the proposed
payment amount for HCPCS code Q3014
(Telehealth originating site facility fee)
is $31.04. Table 9 shows the Medicare
telehealth originating site facility fee
and the corresponding MEI percentage
increase for each applicable time period.
BILLING CODE P
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TABLE 9: The Medicare Telehealth Originating Site Facility Fee
BILLING CODE C
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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
For information related to outpatient
physical therapy, occupational therapy,
speech-language pathology, diabetes
self-management training (DSMT) and
medical nutritional therapy (MNT)
services furnished by institutional staff
in hospitals and other institutional
settings to beneficiaries in their homes
through communication technology,
please refer to section X.A. in the CY
2025 Hospital Outpatient Prospective
Payment System (OPPS) proposed rule
(FR Doc. 2024–15087), on public
inspection July 10, 2024, and publishing
in the Federal Register of July 22, 2024.
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
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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
outlined 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
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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
E:\FR\FM\31JYP2.SGM
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EP31JY24.013
MEI(%)
Time Period
Facility Fee for Q3014
Oct. L 2001 to Dec. 31 2002
NA
$
20.00
2003
3.0
$
20.60
2004
2.9
$
21.20
2005
3.1
$
21.86
2006
2.8
$
22.47
2007
2.1
$
22.94
2008
1.8
$
23.35
2009
1.6
$
23.72
2010
1.2
$
24.00
2011
0.4
$
24.10
2012
0.6
$
24.24
2013
0.8
$
24.43
2014
0.8
$
24.63
2015
0.8
$
24.83
2016
$
25.10
1.1
2017
1.2
$
25.40
2018
1.4
$
25.76
2019
$
26.15
1.5
2020
1.9
$
26.65
2021
1.4
$
27.02
2022
2.1
$
27.59
2023
3.8
$
28.64
2024
4.6
$
29.96
2025*
3.6
$
31.04
*Reflects the most recent estimate of the CY 2025 MEI percentage increase and will be updated in the final rule
based on historical data through the second quarter of 2024.
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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
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
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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
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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
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 discuss our
approach to reviewing RUC
recommendations and developing
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proposed values for specific codes.
When they exist, we also include a
summary of interested party reactions to
our approach. We noted 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
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
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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 suggested that our
actions in adjusting the recommended
work RVUs are 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.
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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 we are proposing
work RVUs for CY 2025; this includes
all codes for which we received RUC
recommendations by February 10, 2024.
The proposed work RVUs, work time
and other payment information for all
CY 2025 payable codes are available on
the CMS website under downloads for
the CY 2025 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 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
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comparative databases, as well as a
comparison with other codes within the
PFS, and consultation with physicians
and health care professionals within
CMS and the Federal Government, as
well as Medicare claims data. We also
assess the methodology and data used to
develop the recommendations
submitted to us by the RUC and other
public commenters and the rationale for
the recommendations. When we
determine that the RUC’s
recommendations appropriately
estimate the direct PE inputs (clinical
labor, disposable supplies, and medical
equipment) required for the typical
service, are consistent with the
principles of relativity, and reflect our
payment policies, we use those direct
PE inputs to value a service. If not, we
refine the recommended PE inputs to
better reflect our estimate of the PE
resources required for the service. We
also confirm whether CPT codes should
have facility and/or nonfacility direct
PE inputs and refine the inputs
accordingly.
Our review and refinement of the
RUC-recommended direct PE inputs
includes many refinements that are
common across codes, as well as
refinements that are specific to
particular services. Table 14 details our
refinements of the RUC’s direct PE
recommendations at the code-specific
level. In section II.B. of this proposed
rule, Determination of 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.
In this proposed rule, we also note that
many of the refinements listed in Table
14 result in changes under the $0.35
threshold and would be unlikely to
result in a change to the RVUs.
We note that the direct PE inputs for
CY 2025 are displayed in the CY 2025
direct PE input files, available on the
CMS website under the downloads for
the CY 2025 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 2025 PE RVUs as
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displayed in Addendum B (see https://
www.cms.gov/medicare/payment/
prospective-payment-systems/hospitaloutpatient/addendum-a-b-updates).
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
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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 referred
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
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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 2025 we
received invoices for several new
supply and equipment items. Tables 17
and 18 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 17 and 18 also
include the number of invoices received
and the number of nonfacility allowed
services for procedures that use these
equipment items. We provide the
nonfacility allowed services so that
interested parties will note the impact
the particular price might have on PE
relativity, as well as to identify items
that are used frequently, since we
believe that interested parties are more
likely to have better pricing information
for items used more frequently. A single
invoice may not be reflective of typical
costs, and we encourage interested
parties to provide additional invoices so
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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
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
2025 are available on the CMS website
under downloads for the CY 2025 PFS
proposed rule at https://www.cms.gov/
Medicare/Medicare-Fee-for-Service-
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Payment/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 section
1833(t)(2)(D), 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 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
with comment period (71 FR 69659
through 69662).
For CY 2025, we identified new and
revised codes to determine which
services meet the definition of ‘‘imaging
services’’ as defined at section
1848(b)(4)(B) of the Act for purposes of
this cap. Beginning for CY 2025, we are
proposing to include the following
services on the list of codes to which the
OPPS cap applies: CPT codes 0868T
(High-resolution gastric
electrophysiology mapping with
simultaneous patient-symptom
profiling, with interpretation and
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report), 0876T (Duplex scan of
hemodialysis fistula, computer-aided,
limited (volume flow, diameter, and
depth, including only body of fistula)),
74263 (Computed tomographic (ct)
colonography, screening, including
image postprocessing), 9X059
(Computerized ophthalmic diagnostic
imaging (eg, optical coherence
tomography [OCT]), posterior segment,
with interpretation and report,
unilateral or bilateral; retina including
OCT angiography), 93X94
(Vasoreactivity study performed with
transcranial Doppler study of
intracranial arteries, complete (List
separately in addition to code for
primary procedure)), 93X95 (Emboli
detection without intravenous
microbubble injection performed with
transcranial Doppler study of
intracranial arteries, complete (List
separately in addition to code for
primary procedure)), and 93X96
(Venous-arterial shunt detection with
intravenous microbubble injection
performed with transcranial Doppler
study of intracranial arteries, complete
(List separately in addition 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.
In the CY 2024 PFS final rule (88 FR
78894), we noted that in response to the
CY 2024 PFS proposed rule,
commenters requested that CMS remove
CPT code 92229 (Imaging of retina for
detection or monitoring of disease;
point-of-care autonomous analysis and
report, unilateral or bilateral) from the
OPPS cap list because it does not
include an associated PC or physician
interpretation and it is primarily
utilized in the physician office setting.
We are soliciting comment on the
appropriateness of applying the OPPS
cap to services such as this for which
the interpretation component is not
captured by work RVUs, and the service
is not split into technical and
professional components. We are more
broadly evaluating how services
involving assistive technologies are
most accurately valued. We note that
the OPPS rate for this service is
currently higher than what would be
paid in a physician office setting, and
therefore the OPPS cap does not
currently apply to CPT code 92229 as of
2024.
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4. Valuation of Specific Codes for CY
2025
(1) Skin Cell Suspension Autograft (CPT
codes 15XX1, 15XX2, 15XX3, 15XX4,
15XX5, 15XX6, 15XX7, and 15XX8)
In September 2023, the CPT Editorial
Panel approved the creation of eight
new CPT codes to describe skin cell
suspension autograft (SCSA)
procedures. The code set includes a
000-day global base code (CPT code
15XX1 (Harvest of skin for skin cell
suspension autograft; first 25 sq cm or
less)) and an add-on code (CPT code
15XX2 (Harvest of skin for skin cell
suspension autograft; each additional
25 sq cm or part thereof (List separately
in addition to code for primary
procedure))) describing the harvesting
component of the procedure, an XXX
global base code (CPT code 15XX3
(Preparation of skin cell suspension
autograft, requiring enzymatic
processing, manual mechanical
disaggregation of skin cells, and
filtration; first 25 sq cm or less of
harvested skin) and an add-on code
(CPT code 15XX4 (Preparation of skin
cell suspension autograft, requiring
enzymatic processing, manual
mechanical disaggregation of skin cells,
and filtration; each additional 25 sq cm
of harvested skin or part thereof (List
separately in addition to code for
primary procedure))) describing the
preparation component of the
procedure, and two 090-day global base
codes and two add-on codes for the
application component to distinguish
between body areas: trunk, arms, and
legs with CPT codes 15XX5
(Application of skin cell suspension
autograft to wound and donor sites,
including application of primary
dressing, trunk, arms, legs; first 480 sq
cm or less) and 15XX6 (Application of
skin cell suspension autograft to wound
and donor sites, including application
of primary dressing, trunk, arms, legs;
each additional 480 sq cm or part
thereof (List separately in addition to
code for primary procedure)); and face,
scalp, eyelids, mouth, neck, ears, orbits,
genitalia, hands, feet, or multiple digits
with CPT codes 15XX7 (Application of
skin cell suspension autograft to wound
and donor sites, including application
of primary dressing, face, scalp, eyelids,
mouth, neck, ears, orbits, genitalia,
hands, feet, and/or multiple digits; first
480 sq cm or less) and 15XX8
(Application of skin cell suspension
autograft to wound and donor sites,
including application of primary
dressing, face, scalp, eyelids, mouth,
neck, ears, orbits, genitalia, hands, feet,
and/or multiple digits; each additional
480 sq cm or part thereof (List
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separately in addition to code for
primary procedure)).
We disagree with the RUCrecommended work RVUs of 3.00, 2.00,
2.51, 2.00, 10.97, 2.50, 12.50, and 3.00
for CPT codes 15XX1 through 15XX8,
respectively, and are proposing
contractor-pricing for these CPT codes
due to concerns with the coding
structure of the code family and the
total physician time that results when
these codes are billed multiple times on
the same date of service for the typical
patient.
We note that our concerns with these
CPT codes are expansive. Firstly, we
note that these CPT codes represent a
segmentation of a single service that is
performed sequentially on the same date
of service. We are seeking comment on
whether the segmentation of the harvest,
preparation, and application is
necessary when these are sequential
service parts of one episode of care, and
could be simplified by having just two
codes that encompass all three service
parts (harvest, preparation, and
application), to differentiate the two
different application areas. We also are
soliciting comment on the base and addon codes’ incremental square
centimeters, considering that the typical
size treatment area described in the
vignettes could result in the add-on
codes being billed multiple times,
particularly for the base application CPT
code 15XX5 and add-on CPT code
15XX6. Based on the meeting notes from
the September 2023 CPT Editorial Panel
meeting, the specialty society initially
structured their coding request to
‘‘bundle’’ the service components into
fewer codes, but it is unclear to us why
these codes were further segmented. We
believe that the very large range of
intraservice times from the 33 burn
surgeons may have been exacerbated by
the harvest, preparation, and
application components of the service
being segmented in this manner. Most
notably, CPT code 15XX1, which
describes the first 25 sq cm of harvest,
base code, had an intraservice survey
time range of 5 to 480 minutes, and CPT
code 15XX7, which describes the first
480 sq cm of application to the face,
scalp, eyelids, mouth, neck, ears, orbits,
genitalia, hands, feet, and/or multiple
digits, had an intraservice survey time
range of 10 to 360 minutes.
We note that the survey median
intraservice times for CPT codes 15XX1
through 15XX8 contradict numerous
publicly available sources that describe
much lower times for this service or
specific service parts. Most notably, the
manufacturer of the RECELL Autologous
Cell Harvesting Device (RECELL®
System) used in this service, indicates
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that a suspension of Spray-On SkinTM
Cells using a small sample of the
patient’s own skin for the treatment of
thermal burn wounds and full-thickness
skin defects is ‘‘prepared and applied at
the point of care in as little as 30
minutes.’’ 11 Additionally, Temple
University Hospital published a news
article on December 20, 2019, just 11
months after the U.S. Food and Drug
Administration (FDA) approval of the
RECELL® System for the treatment of
acute thermal second and third-degree
burns in adult patients in January 2019,
stating that the entire process of skin
sample collection, enzyme solution
preparation, and suspension spraying/
application ‘‘can take as little as 30
minutes’’ and ‘‘treat a wound up to 80
times the size of the donor skin
sample.’’ 12 Additionally, an article
published in Europe PubMed Central
states that the procedure takes
approximately 30 minutes and is
performed by a burn surgeon trained in
how to use RECELL® System, and does
not require specialized laboratory
staff.13 Additionally, a 2007 study
aimed at comparing the results from the
RECELL® System and the classic skin
grafting for epidermal replacement in
deep partial thickness burns showed a
total procedure time of 59±4 minutes for
the RECELL® System group.14
More granularly, the FDA’s
Instructions for Use of the RECELL®
Autologous Cell Harvesting Device state
that ‘‘if a skin sample is harvested and
processed according to these
instructions, it should require between
15 and 30 minutes of contact with the
Enzyme’’.15 Additionally, the National
Institute for Health and Care Excellence
(NICE) produced guidance on using the
RECELL® System based on the
consideration of evidence submitted
and the views of expert advisers, and
stated that the harvested skin is added
to the proprietary enzyme solution in a
processing unit and heated for 15 to 30
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11 https://avitamedical.com/.
12 Temple Burn Center Using Spray-On SkinTM
Cells Technology to Offer Patients a New, Less
Invasive Option for the Treatment of Severe Burns.
(2019, December 20). https://medicine.temple.edu/
news/temple-burn-center-using-spray-skin-cellstechnology-offer-patients-new-less-invasive-option.
13 Cooper-Jones B, Visintini S. A Noncultured
Autologous Skin Cell Spray Graft for the Treatment
of Burns. In: CADTH Issues in Emerging Health
Technologies. Canadian Agency for Drugs and
Technologies in Health, Ottawa (ON); 2016. PMID:
30855772.
14 G. Gravante, M.C. Di Fede, A. Araco, M.
Grimaldi, B. De Angelis, A. Arpino, V. Cervelli, A.
Montone, A randomized trial comparing ReCell®
system of epidermal cells delivery versus classic
skin grafts for the treatment of deep partial
thickness burns, Burns, Volume 33, Issue 8, 2007,
Pages 966–972, ISSN 0305–4179, https://doi.org/
10.1016/j.burns.2007.04.011.
15 https://www.fda.gov/media/169630/download.
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minutes to disaggregate the cells. The
skin is then removed and scraped with
a scalpel to develop a plume of cells.
These cells are added to a buffer
solution, aspirated and filtered to create
a cell suspension that contains
keratinocytes, melanocytes, fibroblasts
and Langerhans cells.16 This correlates
to the preparation component of the
service described by CPT codes 15XX3
and 15XX4, for which the RUC
recommended the survey median time
of 33 and 28 minutes, respectively.
We believe that the publicly available
sources that make representations about
the total service and preparation times
contradict the RUC-recommended
median times based on the survey of 33
burn surgeons. Moreover, when we
considered how the add-on CPT codes
15XX2, 15XX4, 15XX6, and 15XX8
would be billed based on the typical
patient described in the vignettes, we
believe the survey times are inflated
compared to the publicly available
sources, likely due to how the survey
respondents considered the service
given the segmentation of the code set.
For example, the vignette for CPT code
15XX5 describing the application to the
trunk, arms, and legs says ‘‘A 35-yearold male sustained partial-thickness
thermal burns on his trunk and arms
measuring 3,600 sq cm. A skin cell
suspension autograft is applied to 480
sq cm of the wound bed.’’ Of the 33
burn surgeons surveyed, 96 percent
found this vignette to be typical. Given
the typical sq cm application area of
3,600 sq cm and the expansion ratio of
harvested and prepared skin to
treatment skin for application of 1:80,
the typical episode of care would
constitute 1 unit of both CPT codes
15XX1 and 15XX2 for harvesting, 1 unit
of both CPT codes 15XX3 and 15XX4 for
preparation, 1 unit of CPT code 15XX5
for the first 480 sq cm of application,
and 7 units of CPT code 15XX6 for the
remaining 3,120 sq cm of application
area. When the RUC-recommended
intraservice and total times (not
including the post-operative visit time
for CPT code 15XX5) for all the units
billed on the same date of service as
sequential service parts are summed, the
intraservice time totals to 399 minutes
and total time (not including the postoperative visit time included in the
16 National Institute for Health and Care
Excellence. The ReCell Spray-On Skin system for
treating skin loss, scarring and depigmentation after
burn injury. Medical technologies guidance
[MTG21] [internet]. 2014. [Accessed 16 Nov 2017].
https://www.nice.org.uk/guidance/mtg21/
documents/the-recell-sprayon-skin-system-fortreating-skin-loss-scarring-and-depigmentationafter-burn-injury-medical-technology-consultationdocument.
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global period for CPT code 15XX5)
totals to 529 minutes. The intraservice
time total alone is nearly 6 and 2/3
hours.
We note the RUC recommended that
CPT codes 15XX1 through 15XX8 be
placed on the New Technology list to be
re-reviewed by the RUC for both work
and PE for the September 2026 or
January 2027 RUC meeting when 2025
Medicare utilization data is available,
and at that time, the RUC would
consider if other specialties were
performing the service and if the service
was performed in the non-facility
setting. We look forward to re-reviewing
these CPT codes when
recommendations are re-submitted with
more robust and inclusive survey data.
In the meantime, we encourage the
reconsideration of the family’s coding
structure by the CPT Editorial Panel
given the challenging aspects of this
service, including the fact that the
current coding structure represents a
severely segmented single episode of
care with troublesome billing patterns
for the typical patient, particularly for
the add-on CPT code 15XX6 describing
the additional 480 sq cm increments of
application on the trunk, arms, and legs.
This code is particularly concerning
because the coding structure of the
family requires 7 units of add-on CPT
code 15XX6 to be billed for the typical
patient. Similarly, the typical patient
described in the vignettes for this family
of codes would require 3 units of addon CPT code 15XX8 due to the coding
structure.
We are also seeking feedback on the
recommended global period for CPT
code 15XX3. The RUC recommended an
XXX global period, which indicates that
the global concept does not apply, but
we believe a 000-day global period,
indicating an endoscopic or minor
procedure with related preoperative and
postoperative relative values on the day
of the procedure only in the fee
schedule payment amount, may be more
appropriate given the nature of the
service (which is intertwined with the
other codes in the series) and that the
entire service cannot be completed
without 15XX3. This would allow the
entire service to run within a surgical
global period.
We note that we believe contractorpricing is appropriate for CPT codes
15XX1 through 15XX8 until
reconsideration of the coding structure
and re-survey is complete, given the
concerning aspects of the CPT codes.
We note that this service is currently
billed for using contractor-priced CPT
code 17999 (Unlisted procedure, skin,
mucous membrane and subcutaneous
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tissue) and the eight new codes are
expected to be a very low utilization.
(2) Hand, Wrist, & Forearm Repair &
Recon (CPT Codes 25310, 25447, 2X005,
and 26480)
In September 2022, the RUC referred
CPT codes 26480 and 25447 to the CPT
Editorial Panel for a code bundling
solution. In May 2023, the CPT Editorial
Panel approved a new bundled code
(CPT code 2X005) to report intercarpal
or carpometacarpal joint suspension
arthroplasty, including transfer or
transplant of tendon, with interposition
when performed while CPT code 25447
was revised to clarify that the code only
included interposition of a tendon and
not suspension. This family of codes
was surveyed for the September 2023
RUC meeting.
We disagree with the RUCrecommended work RVU of 9.50 for
CPT code 25310 (Tendon
transplantation or transfer, flexor or
extensor, forearm and/or wrist, single;
each tendon) and we are instead
proposing a work RVU of 9.00 based on
the survey 25th percentile result. In
reviewing CPT code 25310, we noted
that the recommended intraservice time
was unchanged at 60 minutes in the
new survey; however, the RUCrecommended work RVU is increasing
from the current 8.08 to 9.50. Although
we do not imply that changes in work
time as reflected in survey values must
equate to a one-to-one or linear change
in the valuation of work RVUs, we
believe that since the two components
of work are time and intensity, increases
in the recommended work RVU should
typically be reflected in increases in the
surveyed work time. We recognize that
the total time for CPT code 25310 is
increasing from 235 minutes to 263
minutes (an increase of 12 percent) due
to changes in the code’s post-operative
office visits which will now take place
at a higher level. However, this again
does not match the increase in the
recommended work RVU, which is
increasing from 8.08 to 9.50
(approximately 18 percent). We believe
that it would be more accurate to
propose the survey 25th percentile work
RVU of 9.00 for CPT code 25310 which
matches this increase in the total work
time. We also note that the intensity of
CPT code 25310 is decreasing, not
increasing, as recommended by the RUC
which further suggests that a work RVU
of 9.50 would not be appropriate for this
code given the surveyed work times.
We disagree with the RUCrecommended work RVU of 11.14 for
CPT code 25447 (Arthroplasty,
intercarpal or carpometacarpal joints;
interposition (eg, tendon)) and we are
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instead proposing a work RVU of 10.50
based on the survey 25th percentile
result. In reviewing CPT code 25447, we
noted that the recommended
intraservice time was decreasing from
100 minutes to 75 minutes in the new
survey; however, the RUC
recommended maintaining the current
work RVU of 11.14. Although we do not
imply that changes in work time as
reflected in survey values must equate
to a one-to-one or linear change in the
valuation of work RVUs, we believe that
since the two components of work are
time and intensity, decreases in the
surveyed work time should typically be
reflected in decreases to the work RVU.
We recognize that the total time for CPT
code 25447 is slightly increasing from
278 minutes to 281 minutes (an increase
of about 1 percent) due to changes in the
code’s post-operative office visits which
will now take place at a higher level.
However, we believe that the sizable
decrease in surveyed intraservice work
time (a reduction of approximately 33
percent) better supports proposing the
survey 25th percentile work RVU of
10.50 instead of maintaining the current
work RVU of 11.14. We also disagree
with the RUC that the intensity of CPT
code 25447 is unchanged due to
increases in the post-operative work; we
believe that the sizable decrease in
surveyed intraservice work time
indicates a modest decrease in intensity.
We note again that the intensity of CPT
code 25310 is decreasing, not
increasing, as recommended by the RUC
which suggests that a similar pattern is
likely taking place with clinically
similar procedures elsewhere in the
same code family.
We disagree with the RUCrecommended work RVU of 13.90 for
CPT code 2X005 (Arthroplasty,
intercarpal or carpometacarpal joints;
suspension, including transfer or
transplant of tendon, with interposition,
when performed) and we are instead
proposing a work RVU of 11.85 based
on the survey 25th percentile result. We
note that the RUC typically values new
codes such as CPT code 2X005 using
this survey 25th percentile work RVU as
opposed to the survey median work
RVU that it recommended. The RUC’s
recommendations stated that CPT code
2X005 should be valued higher than
CPT code 25447 due to having higher
intensity, a relationship which is
preserved at our proposed work RVUs of
11.85 and 10.50 respectively. The RUC
also stated in its recommendations that
CPT code 2X005 should be valued
higher than reference CPT code 29828
(Arthroscopy, shoulder, surgical; biceps
tenodesis) because it has more
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intraservice time and total work time.
However, the RUC also stated elsewhere
in its recommendations that the
arthroscopy described by CPT code
29828 is more intense than the
arthroplasty procedures described by
this family of codes, which we believe
supports CPT code 29828 having a
higher work RVU despite its lower work
times. Based on this information, we
believe that proposing the survey 25th
percentile work RVU of 11.85 is the
most accurate valuation for CPT code
2X005.
We disagree with the RUCrecommended work RVU of 9.50 for
CPT code 26480 (Transfer or transplant
of tendon, carpometacarpal area or
dorsum of hand; without free graft, each
tendon) and we are instead proposing a
work RVU of 9.00 based on the survey
25th percentile result. In reviewing CPT
code 26480, we noted that the
recommended intraservice time was
unchanged at 60 minutes in the new
survey; however, the RUCrecommended work RVU is increasing
from the current 6.90 to 9.50. Although
we do not imply that changes in work
time as reflected in survey values must
equate to a one-to-one or linear change
in the valuation of work RVUs, we
believe that since the two components
of work are time and intensity, increases
in the recommended work RVU should
typically be reflected in increases in the
surveyed work time. We recognize that
the total time for CPT code 26480 is
increasing from 227 minutes to 263
minutes (an increase of 16 percent) due
to changes in the code’s post-operative
office visits which will now take place
at a higher level. However, this again
does not match the increase in the
recommended work RVU, which is
increasing from 6.90 to 9.50
(approximately 38 percent). We believe
that it would be more accurate to
propose the survey 25th percentile work
RVU of 9.00 for CPT code 26480 which
more closely matches this increase in
the total work time. We also note that
CPT codes 25310 and 26480 were
surveyed as having identical work times
and identical survey 25th percentile and
survey median work RVUs. We concur
with the RUC that these two codes
should be valued at the same work RVU,
however we continue to believe that the
survey 25th percentile work RVU of
9.00 is a more accurate choice in both
cases. We are proposing the RUCrecommended direct PE inputs for all
four codes in the family without
refinement.
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(3) CAR–T Therapy Services (CPT Codes
3X018, 3X019, 3X020, and 3X021)
In September 2023, the CPT Editorial
Panel deleted four category III codes
(0537T–0540T) and approved the
addition of four new codes (3X018–
3X021) that describe only steps of the
complex CAR–T Therapy process
performed and supervised by
physicians. The RUC recommended four
different work RVUs for codes 3X018,
3X019, 3X020, and 3X021 and only
recommended direct PE values for code
3X021.
For CPT code 3X018 (Chimeric
antigen receptor T-cell (CAR–T)
therapy; harvesting of blood-derived T
lymphocytes for development of
genetically modified autologous CAR–T
cells, per day) the RUC recommended a
work RVU of 1.94. For CPT code 3X019
(Chimeric antigen receptor T-cell (CAR–
T) therapy; preparation of blood-derived
T lymphocytes for transportation (eg,
cryopreservation, storage)) the RUC
recommended a work RVU of 0.79. For
CPT code 3X021 (Chimeric antigen
receptor T-cell (CAR–T) therapy; CAR–
T cell administration, autologous) the
RUC recommended a work RVU of 3.00.
For CPT code 3X020 (Chimeric antigen
receptor T-cell (CAR–T) therapy; receipt
and preparation of CAR–T cells for
administration) the RUC recommended
a work RVU of 0.80 and for CPT code
3X020, we are proposing the RUCrecommended work RVU of 0.80. We
are proposing the RUC-recommended
work RVUs for CPT codes 3X018,
3X019, and 3X021 respectively.
As mentioned previously, the RUC
recommended direct PE values for only
one code, CPT code 3X021, and the RUC
recommended that the non-facility PE
RVU for CPT codes 3X018–3X020
should be contractor-priced. However,
contractor pricing can only be applied at
the whole code level, not to a single
component of the valuation. Therefore,
for CPT codes 3X018–3X020 we are
treating these codes as having no
recommended direct PE values and are
seeking comment on direct PE values for
these codes. We are proposing the RUCrecommended direct PE inputs for CPT
code 3X021.
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(4) Therapeutic Apheresis and
Photopheresis (CPT Codes 36514,
36516, and 36522)
In the CY 2024 PFS final rule, we
finalized 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)
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as potentially misvalued, as we believed
there may have been a possible disparity
with the clinical labor type (88 FR
78848). As a result, the PE clinical labor
type was reviewed for these three codes
at the January 2024 RUC meeting, with
no work review. The PE Subcommittee
and the RUC agreed that clinical staff
code L042A (RN/LPN) did not
appropriately represent the work of an
Apheresis Nurse Specialist. There is not
a clinical staff code for an Apheresis
Nurse Specialist; however, the RUC
agreed with the specialty societies’
recommendation that the training and
experience of an oncology nurse
(clinical staff code L056A, RN/OCN)
would more accurately reflect the work
of an apheresis nurse for these CPT
codes. The RUC submitted new PE
recommendations for these three codes
based on the use of the L056A clinical
labor type.
We are proposing the RUCrecommended direct PE inputs for CPT
codes 36514, 36516, and 36522 without
refinement. The RUC did not make
recommendations and we are not
proposing any changes to the work RVU
for CPT codes 36514, 36516, and 36522.
(5) Intra-Abdominal Tumor Excision or
Destruction (CPT Codes 4X015, 4X016,
4X017, 4X018, and 4X019)
In May 2023, the CPT Editorial Panel
created five new codes to describe the
sum of the maximum length of intraabdominal (that is, peritoneal,
mesenteric, retroperitoneal), primary or
secondary tumor(s) or cyst(s) excised or
destroyed: CPT code 4X015 (Excision or
destruction, open, intra-abdominal (i.e.,
peritoneal, mesenteric, retroperitoneal),
primary or secondary tumor(s) or
cyst(s), sum of the maximum length of
tumor(s) or cyst(s); 5 cm or less), CPT
code 4X016 (Excision or destruction,
open, intra-abdominal (i.e., peritoneal,
mesenteric, retroperitoneal), primary or
secondary tumor(s) or cyst(s), sum of the
maximum length of tumor(s) or cyst(s);
5.1 to 10 cm), CPT code 4X017 (Excision
or destruction, open, intra-abdominal
(i.e., peritoneal, mesenteric,
retroperitoneal), primary or secondary
tumor(s) or cyst(s), sum of the maximum
length of tumor(s) or cyst(s); 10.1 to 20
cm), CPT code 4X018 (Excision or
destruction, open, intra-abdominal (i.e.,
peritoneal, mesenteric, retroperitoneal),
primary or secondary tumor(s) or
cyst(s), sum of the maximum length of
tumor(s) or cyst(s); 20.1 to 30 cm), and
CPT code 4X019 (Excision or
destruction, open, intra-abdominal (i.e.,
peritoneal, mesenteric, retroperitoneal),
primary or secondary tumor(s) or
cyst(s), sum of the maximum length of
tumor(s) or cyst(s); greater than 30 cm).
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These new CPT codes will replace
existing CPT codes 49203 (Excision or
destruction, open, intra-abdominal
tumors, cysts or endometriomas, 1 or
more peritoneal, mesenteric, or
retroperitoneal primary or secondary
tumors; largest tumor 5 cm diameter or
less), 49204 (Excision or destruction,
open, intra-abdominal tumors, cysts or
endometriomas, 1 or more peritoneal,
mesenteric, or retroperitoneal primary
or secondary tumors; largest tumor 5.1–
10.0 cm diameter), and 49205 (Excision
or destruction, open, intra-abdominal
tumors, cysts or endometriomas, 1 or
more peritoneal, mesenteric, or
retroperitoneal primary or secondary
tumors; largest tumor greater than 10.0
cm diameter) that described tumor
excision or destruction based on the size
of the single largest tumor, cyst, or
endometrioma removed, no matter the
number of tumors. For CY 2025, the
RUC recommended a work RVU of
22.00 for CPT code 4X015, a work RVU
of 28.65 for CPT code 4X016, a work
RVU of 34.00 for CPT code 4X017, a
work RVU of 45.00 for CPT code 4X018,
and a work RVU of 55.00 for CPT code
4X019.
We are proposing the RUCrecommended work RVUs of 22.00 for
CPT code 4X015, 28.65 for CPT code
4X016, and 34.00 for CPT code 4X017.
We disagree with the RUCrecommended work RVU of 45.00 for
CPT code 4X018 and we are proposing
a work RVU of 40.00 based on the
survey 25th percentile. Compared to the
predecessor CPT code 49205, the intraservice time ratio for CPT code 4X018
suggests a work RVU of 41.51 and the
total time ratio suggests a work RVU of
38.02. These changes in surveyed work
time as compared with predecessor CPT
code 49205 suggest that the
recommended work RVU of 45.00 is
inappropriately high. We also note that
the RUC recommended the survey 25th
percentile work RVU for CPT codes
4X015, 4X016, and 4X017. Therefore,
we believe that proposing a work RVU
of 40.00 for CPT code 4X018 keeps the
valuation consistent with the other CPT
codes in this family. Our proposed work
RVU of 40.00 for CPT code 4X018 is
supported by the following reference
CPT codes with similar intra-service
time (310 minutes) and similar total
time (814 minutes): reference CPT code
69970 (Removal of tumor, temporal
bone) with a work RVU of 32.41 with
330 minutes intra-service time and 793
minutes of total time, and reference CPT
code 33864 (Ascending aorta graft, with
cardiopulmonary bypass with valve
suspension, with coronary
reconstruction and valve-sparing aortic
root remodeling (e.g., David Procedure,
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Yacoub Procedure)) with a work RVU of
60.80 with 300 minutes of intra-service
time and 838 minutes of total time. We
believe the proposed work RVU of 40.00
is a more appropriate value overall than
45.00 when compared to the range of
codes with similar intra-service time
and similar total time.
We disagree with the RUCrecommended work RVU of 55.00 for
CPT code 4X019 and we are proposing
a work RVU of 50.00 based on the
survey 25th percentile. Compared to the
predecessor CPT code 49205, the intraservice time ratio for CPT code 4X019
suggests a work RVU of 48.21 and the
total time ratio suggests a work RVU of
48.86. These changes in surveyed work
time as compared with predecessor CPT
code 49205 suggest that the
recommended work RVU of 55.00 is
inappropriately high. We also note again
that the RUC recommended the survey
25th percentile work RVU for CPT codes
4X015, 4X016, and 4X017. Therefore,
we believe that proposing a work RVU
of 50.00 for CPT code 4X019 keeps the
valuation consistent with the other CPT
codes in this family. Our proposed work
RVU of 50.00 for CPT code 4X019 is
supported by the following reference
CPT codes with similar intra-service
time (360 minutes) and similar total
time (1,046 minutes): reference CPT
code 61598 (Transpetrosal approach to
posterior cranial fossa, clivus or
foramen magnum, including ligation of
superior petrosal sinus and/or sigmoid
sinus) with a work RVU of 36.53 with
377.7 minutes intra-service time and
1,048.1 minutes of total time, and
reference CPT code 47140 (Donor
hepatectomy (including cold
preservation), from living donor; left
lateral segment only (segments II and
III)) with a work RVU of 59.40 with 355
minutes of intra-service time and 1,073
minutes of total time. We believe the
proposed RVU of 50.00 is a more
appropriate value overall than 55.00
when compared to the range of codes
with similar intra-service time and
similar total time.
We also note that the RUC’s
recommendations for the first three
codes in the family (CPT codes 4X015–
4X017) maintained the same amount of
intensity as their respective predecessor
codes, and in fact slightly decreased in
intensity in the case of CPT codes
4X015 and 4X016. However, the RUC
recommended a notable increase in
intensity for CPT codes 4X018 and
4X019 over predecessor code 49205 due
to its selection of the survey median
work RVU in both cases. We do not
believe that this increase in intensity for
CPT codes 4X018 and 4X019 is
warranted due to their clinical
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similarities to the previous coding in the
family, especially given that CPT code
49205 had the lowest intensity in the
family. We believe that this intensity
argument further supports our choice to
propose the survey 25th percentile work
RVU for these two codes, matching the
RUC recommendations for CPT code
4X015–4X017.
We are proposing the RUCrecommended direct PE inputs for CPT
codes 4X015, 4X016, 4X017, 4X018, and
4X019 without refinement.
(6) Bladder Neck and Prostate
Procedures (CPT Codes 5XX05 and
5XX06)
In September 2023, the CPT Editorial
Panel created two Category I CPT codes
to describe the insertion or removal of
a temporary device to remodel the
bladder neck and prostate using
pressure to create necrosis and relieve
lower urinary tract symptoms (LUTS)
secondary to benign prostate
hyperplasia (BPH). These two new 000day global Category I codes were
surveyed and reviewed for the January
2024 RUC meeting.
At the January 2024 RUC meeting, the
specialty society indicated that CPT
code 5XX05’s survey 25th percentile
work RVU of 3.91 was too high for this
procedure compared to other services in
the physician fee schedule with similar
intra-service time. The specialty society
recommended, and the RUC agreed that
the recommended work RVU for CPT
code 5XX05 should be crosswalked to
CPT code 52284 (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). Because these procedures
are similar in intensity and both require
precise placement of an intraurethral
device, we concur with the RUC and we
are proposing the RUC recommended
work RVU of 3.10 for CPT code 5XX05.
At the January 2024 RUC meeting, the
specialty society indicated that CPT
code 5XX06’s survey 25th percentile
work RVU of 2.00 was too high for this
procedure compared to other services in
the physician fee schedule with similar
intra-service time. The specialty society
recommended, and the RUC agreed, that
CPT code 5XX06 should have a direct
work RVU crosswalk to CPT code 27096
(Injection procedure for sacroiliac joint,
anesthetic/steroid, with image guidance
(fluoroscopy or CT) including
arthrography when performed). We are
proposing the RUC recommended work
RVU of 1.48 for CPT code 5XX06.
We are also proposing the RUCrecommended direct PE inputs for CPT
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codes 5XX05 and 5XX06 without
refinement. However, we note possible
duplications in two of the supply items
within CPT code 5XX05. Specifically,
supply item SB027 (gown, staff,
impervious) is already included in
supply item SA042 (pack, cleaning and
disinfecting, endoscope), and supply
item SB024 (gloves, sterile) is included
in supply items SA058 (pack, urology
cystoscopy visit). We are seeking
comments on whether a total of three
SB027 impervious staff gowns and two
SB024 pairs of sterile gloves would be
typical and necessary when providing
this procedure.
(7) MRI-Monitored Transurethral
Ultrasound Ablation of Prostate (CPT
Codes 5X006, 5X007, and 5X008)
At the April 2023 CPT Editorial Panel
meeting, three new CPT codes were
approved for MRI-monitored
transurethral ultrasound ablation
(TULSA). These codes were surveyed
for the September 2023 RUC meeting
and recommendations submitted to
CMS for inclusion in the CY 2025 PFS
proposed rule.
For CY 2025, we are proposing the
RUC-recommended work RVUs for all
three CPT codes. However, we note that
interested parties may have concerns
regarding the experience of the survey
respondents and the intra-service times
provided in the survey data. We
welcome commenters to provide
additional data that we could consider
in the valuation of the work and direct
PE inputs for these CPT codes. We are
proposing a work RVU of 4.05 for CPT
code 5X006 (Insertion of transurethral
ablation transducers for delivery of
thermal ultrasound for prostate tissue
ablation, including suprapubic tube
placement during the same session and
placement of an endorectal cooling
device, when performed), a work RVU of
9.80 for CPT code 5X007 (Ablation of
prostate tissue, transurethral, using
thermal ultrasound, including magnetic
resonance imaging guidance for, and
monitoring of, tissue ablation), and a
work RVU of 11.50 for CPT code 5X008
(Ablation of prostate tissue,
transurethral, using thermal ultrasound,
including magnetic resonance imaging
guidance for, and monitoring of, tissue
ablation; with insertion of transurethral
ultrasound transducers for delivery of
the thermal ultrasound, including
suprapubic tube placement and
placement of an endorectal cooling
device, when performed). We are also
proposing the RUC-recommended direct
PE inputs for CPT codes 5X006, 5X007,
and 5X008 without refinement.
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(8) Insertion of Cervical Dilator (CPT
Code 59200)
In the CY 2024 PFS final rule, we
finalized CPT Code 59200 (Insertion of
cervical dilator (e.g., laminaria,
prostaglandin) (separate procedure)) as
potentially misvalued. The code is to be
used to report the total duration of time
spent on a patient history and physical,
reviewing lab resulting, discussing risk
and benefits of the procedure, obtaining
consent, performing the procedure, and
assessing the patient post-procedure.
The RUC reviewed the work RVU and
PE inputs for CPT code 59200 at their
January 2024 meeting. We are proposing
the RUC-recommended work RVU of
1.20 for CPT code 59200. We are also
proposing the RUC-recommended direct
PE inputs for CPT code 59200 without
refinements.
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(9) Guided High Intensity Focused
Ultrasound (CPT Code 6XX00)
In September 2023, the CPT Editorial
Panel created a new Category I code to
describe magnetic resonance image
guided high intensity focused
ultrasound intracranial ablation for
treatment of a severe central tremor that
is recalcitrant to other medical
treatments. This service is typically
performed by a neurosurgeon without
the involvement of a separate
radiologist. This new code replaces the
existing Category III code 0398T.
We are not proposing the RUCrecommended work RVU of 18.95 for
CPT code 6XX00 and are instead
proposing a work RVU of 16.60 based
on a crosswalk to CPT code 61626
(Transcatheter permanent occlusion or
embolization (e.g., for tumor
destruction, to achieve hemostasis, to
occlude a vascular malformation),
percutaneous, any method; non-central
nervous system, head or neck
(extracranial, brachiocephalic branch)),
which describes a similar tumor
destruction service that has similar time
and intensity values to this service, and
we support this value by referencing
CPT code 33889 (Open subclavian to
carotid artery transposition performed
in conjunction with endovascular repair
of descending thoracic aorta, by neck
incision, unilateral) and 33894
(Endovascular stent repair of
coarctation of the ascending, transverse,
or descending thoracic or abdominal
aorta, involving stent placement; across
major side branches). We do not believe
that this service is significantly more
intense than the key reference codes,
CPT codes 61736 (Laser interstitial
thermal therapy (LITT) of lesion,
intracranial, including burr hole(s), with
magnetic resonance imaging guidance,
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injection(s), including imaging
guidance, when performed), and 6XX12
(Lower extremity fascial plane block,
unilateral; by continuous infusion(s),
including imaging guidance, when
performed) to report thoracic or lower
extremity fascial plane blocks, typically
used for post-operative pain
management. Four existing CPT codes
describing transversus abdominis plane
(TAP) blocks, 64486 (Transversus
abdominis plane (TAP) block
(abdominal plane block, rectus sheath
block) unilateral; by injection(s)
(includes imaging guidance, when
performed)), 64487 (Transversus
abdominis plane (TAP) block
(abdominal plane block, rectus sheath
block) unilateral; by continuous
infusion(s) (includes imaging guidance,
(10) Percutaneous Radiofrequency
when performed)), 64488 (Transversus
Ablation of Thyroid (CPT Codes 6XX01
abdominis plane (TAP) block
and 6XX02)
(abdominal plane block, rectus sheath
In January 2024, the RUC surveyed
block) bilateral; by injections (includes
codes 6XX01 (Ablation of 1 or more
imaging guidance, when performed))
thyroid nodule(s), one lobe or the
64489 (Transversus abdominis plane
isthmus, percutaneous, including
(TAP) block (abdominal plane block,
imaging guidance, radiofrequency) and
rectus sheath block) bilateral; by
its respective add-on code 6XX02
continuous infusions (includes imaging
(Ablation of 1 or more thyroid nodule(s), guidance, when performed)), were
additional lobe, percutaneous, with
included as part of this code family for
imaging guidance, radiofrequency (List
RUC review in January 2024.
separately in addition to code for
We are proposing the RUCprimary service) and recommended both recommended work RVU for all ten
work RVUs and PE values for this code
codes in this family. We are proposing
family.
a work RVU of 1.50 for CPT code
For CPT code 6XX01, the RUC
6XX07, 1.74 for CPT code 6XX08, 1.67
recommended a work RVU of 5.75 and
for CPT code 6XX09, 1.83 for CPT code
we are proposing the RUC6XX10, 1.34 for CPT code 6XX11, 1.67
recommended work RVU of 5.75.
for CPT code 6XX12, 1.20 for CPT code
For add-on code CPT 6XX02, the RUC 64486, 1.39 for CPT code 64487, 1.40 for
recommended a work RVU of 4.25 and
CPT code 64488, and 1.75 for CPT code
we are proposing the RUC64489.
recommended work RVU for this code.
We are also proposing the RUC
We are also proposing the RUCrecommended direct PE inputs for CPT
recommended direct PE values for both
codes 6XX08, 6XX09, 6XX10, 6XX12,
64487, 64488, and 64489. We disagree
codes 6XX01 and 6XX02.
with one of the RUC recommended
(11) Fascial Plane Blocks (CPT Codes
direct PE inputs for CPT codes 6XX07,
6XX07, 6XX08, 6XX09, 6XX10, 6XX11,
6XX11, and 64486. The RUC stated they
6XX12, 64486, 64487, 64488, and
believe that there is a rounding error in
64489)
the CA019 clinical labor time, ‘‘Assist
In September 2023, the CPT Editorial
physician or other qualified healthcare
Panel created six new Category I CPT
professional—directly related to
codes, CPT code 6XX07 (Thoracic
physician work time (67%)’’, for these
fascial plane block, unilateral; by
three codes. We disagree with the RUC
injection(s), including imaging
that there are rounding errors in these
guidance, when performed), 6XX08
codes and we are proposing to maintain
(Thoracic fascial plane block, unilateral; the current 7 minutes of CA019 clinical
by continuous infusion(s), including
labor time for CPT codes 6XX07, 6XX11,
imaging guidance, when performed),
and 64486. We note that this matches
6XX09 (Thoracic fascial plane block,
the pattern of CA019 clinical labor time
bilateral; by injection(s), including
for the rest of the codes in the family,
imaging guidance, when performed),
which remained the same or slightly
6XX10 (Thoracic fascial plane block,
decreased in each case. This refinement
bilateral; by continuous infusion(s),
to the CA019 clinical labor time also
including imaging guidance, when
means that we are proposing a decrease
performed), 6XX11 (Lower extremity
of 0.5 minutes to the equipment time for
fascial plane block, unilateral; by
the stretcher (EF018) and 3-channel ECG
when performed; single trajectory for 1
simple lesion) and 61737 (Laser
interstitial thermal therapy (LITT) of
lesion, intracranial, including burr
hole(s), with magnetic resonance
imaging guidance, when performed;
multiple trajectories for multiple or
complex lesion(s)), as the RUCrecommended work value implies. Our
proposed work RVU of 16.60 for CPT
code 6XX00 largely matches the
intensity of CPT code 61736 which we
believe is a more accurate valuation for
this service, as opposed to the RUC
recommendation which would have
significantly more intensity.
We are proposing the RUCrecommended direct PE inputs for CPT
code 6XX00 without refinement.
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(EQ011) which decreases from 25.5 to
25 minutes for these three codes. We are
proposing all of the other RUCrecommended direct PE inputs for CPT
codes 6XX07, 6XX11, and 64486
without refinement.
(12) Skin Adhesives (CPT Codes 64590
and 64595 and HCPCS Codes G0168,
G0516, G0517, and G0518)
In April 2022, the RUC approved the
use of SG007 (adhesive, skin
(Dermabond)) for CPT code 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). In April 2023, the PE
Subcommittee reviewed the following
six codes on the Medicare Physician Fee
Schedule 64590, 64595, G0168, G0516,
G0517, G0518 that utilize Dermabond
(supply code S6007) in order to identify
justification for its use versus the
generic version and present its findings
to the RUC for approval. The RUC
reviewed all six codes for PE only and
did not submit work recommendations.
For CPT codes 64590 and 64595 and
HCPCS code G0168 (Wound closure
utilizing tissue adhesive(s) only), the
RUC recommends that CMS remove the
supply input SG007 adhesive, skin
(Dermabond) and add one unit of SH076
adhesive, cyanoacrylate (2ml uou). We
are proposing the RUC-recommended
direct PE inputs for CPT codes 64590
and 64595 and HCPCS code G0168.
Similarly, for HCPCS codes G0516
(Insertion of non-biodegradable drug
delivery implants, 4 or more (services
for subdermal rod implant), G0517
(Removal of non-biodegradable drug
delivery implants, 4 or more (services
for subdermal implants), and G0518
(Removal with reinsertion, nonbiodegradable drug delivery implants, 4
or more (services for subdermal
implants), the RUC recommends that
CMS remove the supply input SG007
adhesive, skin (Dermabond) and add
one unit of SH076 adhesive,
cyanoacrylate (2ml uou). We are
proposing the RUC-recommended direct
PE inputs for HCPCS codes G0516–
G0518.
(13) Iris Procedures (CPT Codes 66680,
66682, and 6X004)
In April 2023, the CPT Editorial Panel
deleted three related Category III CPT
codes, CPT code 0616T (Insertion of iris
prosthesis, including suture fixation and
repair or removal of iris, when
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performed; without removal of
crystalline lens or intraocular lens,
without insertion of intraocular lens),
CPT code 0617T (with removal of
crystalline lens and insertion of
intraocular lens), and CPT code 0618T
(with secondary intraocular lens
placement or intraocular lens exchange).
At the same time, CPT created a new
Category I code 6X004 (Implantation of
iris prosthesis, including suture fixation
and repair or removal of iris, when
performed) which describes insertion of
an artificial iris into an eye with a
partial or complete iris defect due to a
congenital defect or surgical or nonsurgical trauma. The new Category I
CPT code 6X004 replaced the three
Category III codes to simplify reporting.
Concurrent with these updates, the RUC
surveyed the two other 90-day global
iris repair codes, CPT code 66680
(Repair of iris, ciliary body (as for
iridodialysis)) and CPT code 66682
(Suture of iris, ciliary body (separate
procedure) with retrieval of suture
through small incision (e.g., McCannel
suture)).
We disagree with the RUCrecommended work RVU of 10.25 for
CPT code 66680. We are proposing a
work RVU of 7.97 for CPT code 66680
based on a crosswalk to CPT code 67904
(Repair of blepharoptosis; (tarso) levator
resection or advancement, external
approach). When we reviewed CPT
code 66680, we found that the RUC
recommended work RVU does not
maintain relativity with other 90-day
global period codes with the same
intraservice time of 45 minutes and
similar total time around 182 minutes.
The total time ratio between the current
time of 159 minutes and the
recommended time established by the
RUC survey of 182 minutes equals 1.145
percent. This ratio, 1.145 percent, when
applied to the current work RVU of 6.39
would suggest a work RVU of 7.31
which is far below the RUC’s
recommended work RVU of 10.25.
Based on this total time ratio, we believe
a more appropriate work valuation for
CPT code 66680 is 7.97 based on a
crosswalk to CPT code 67904.
We disagree with the RUCrecommended work RVU of 10.87 for
CPT code 66682. We are proposing a
work RVU of 8.74 based on the total
time ratio between the current time of
169.5 minutes and the recommended
time established by the RUC survey of
202 minutes. This ratio equals 1.192
percent, and 1.192 percent of the
current work RVU of 7.33 suggests a
work RVU of 8.74 for CPT code 66682.
When we reviewed CPT code 66682, we
found that the recommended work RVU
was higher than nearly all of the other
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90-day global codes with similar time
values. The RUC’s recommended work
RVU does not maintain relativity with
other 90-day global period codes with
the same intraservice time value of 45
minutes and similar total time of 202.
We found that work RVU crosswalks to
CPT codes of similar intraservice and
total time were too low, such as CPT
code 45171 with a work RVU of 8.13. A
more appropriate work RVU for CPT
code 66682 is 8.74 based on the total
time ratio.
The RUC recommended a work RVU
of 12.80 for CPT 6X004, the RUC survey
25th percentile result, with an
intraservice time of 60 minutes and a
total time of 224 minutes. We disagree
with the RUC-recommended work RVU
of 12.80 for CPT code 6X004. Although
we disagree with the RUCrecommended work RVU, we concur
that the relative difference in work
between CPT codes 66682 and 6X004 is
equivalent to the recommended interval
of 1.93 RVUs. Therefore, we are
proposing a work RVU of 10.67 for CPT
code 6X004, based on the recommended
interval of 1.93 additional RVUs above
our proposed work RVU of 8.74 for CPT
code 66682. This proposed work RVU of
10.67 falls between the work RVU
values of existing codes with similar
intraservice and total time values. For
example, CPT code 65850 (60 minutes
of intraservice time and 233 minutes of
total time) has a work RVU of 11.39 and
CPT code 24164 with the same
intraservice time and 228 minutes of
total time has a work RVU of 10.00. We
believe that the work valuation of these
CPT codes, which bracket our proposed
work RVU of 10.67, provide additional
support for our proposed valuation.
We also disagree with the RUC’s
recommended work RVUs for the codes
in this family because they suggest that
there has been a tremendous increase in
intensity as compared to how these
services have historically been valued.
CPT code 66680 is more than doubling
in intensity at the RUC’s recommended
work RVU of 10.25, which we do not
believe to be the case given that the
code descriptor remains unchanged and
the surveyed intraservice work time is
unchanged at 45 minutes. This same
pattern holds true for CPT code 66682,
which would be increasing in intensity
by more than 50% at the RUC’s
recommended work RVU of 10.87, and
which similarly has no change in its
code descriptor and a modest increase
in its surveyed work time. We concur
that the intensity of these services has
likely gone up over time, which is why
we are proposing modest intensity
increases for both codes, however we
continue to disagree that the very
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substantial intensity increases
recommended by the RUC would be
accurate for this code family. We believe
that our proposed work RVUs are more
in line with how these services have
historically been valued and better
maintain relativity with the rest of the
fee schedule.
We are proposing the direct PE inputs
as recommended by the RUC for all
three codes in the family without
refinement.
(14) Magnetic Resonance Examination
Safety Procedures (CPT Codes 7XX00,
7XX01, 7XX02, 7XX03, 7XX04, and
7XX05)
In September 2023, the CPT Editorial
Panel created a new code family to
describe magnetic resonance (MR)
examination safety procedures and
capture the physician work involving
patients with implanted medical
devices that require access to MR
diagnostic procedures: CPT code 7XX00
(MR safety implant and/or foreign body
assessment by trained clinical staff,
including identification and verification
of implant components from
appropriate sources (e.g., surgical
reports, imaging reports, medical device
databases, device vendors, review of
prior imaging), analyzing current MR
conditional status of individual
components and systems, and
consulting published professional
guidance with written report; initial 15
minutes), CPT code 7XX01 (MR safety
implant and/or foreign body assessment
by trained clinical staff, including
identification and verification of
implant components from appropriate
sources (e.g., surgical reports, imaging
reports, medical device databases,
device vendors, review of prior imaging),
analyzing current MR conditional status
of individual components and systems,
and consulting published professional
guidance with written report; each
additional 30 minutes (List separately in
addition to code for primary
procedure)), CPT code 7XX02 (MR
safety determination by a physician or
other qualified health care professional
responsible for the safety of the MR
procedure, including review of implant
MR conditions for indicated MR exam,
analysis of risk versus clinical benefit of
performing MR exam, and
determination of MR equipment,
accessory equipment, and expertise
required to perform examination with
written report), CPT code 7XX03 (MR
safety medical physics examination
customization, planning and
performance monitoring by medical
physicist or MR safety expert, with
review and analysis by physician or
qualified health care professional to
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prioritize and select views and imaging
sequences, to tailor MR acquisition
specific to restrictive requirements or
artifacts associated with MR conditional
implants or to mitigate risk of nonconditional implants or foreign bodies
with written report), CPT code 7XX04
(MR safety implant electronics
preparation under supervision of
physician or other qualified health care
professional, including MR-specific
programming of pulse generator and/or
transmitter to verify device integrity,
protection of device internal circuitry
from MR electromagnetic fields, and
protection of patient from risks of
unintended stimulation or heating while
in the MR room with written report), and
CPT code 7XX05 (MR safety implant
positioning and/or immobilization
under supervision of physician or
qualified health care professional,
including application of physical
protections to secure implanted medical
device from MR-induced translational
or vibrational forces, magnetically
induced functional changes, and/or
prevention of radiofrequency burns from
inadvertent tissue contact while in the
MR room with written report). For CY
2025, new CPT codes 7XX00 and 7XX01
are PE only services that represent the
preparatory research and review
completed by clinical staff (that is, MRI
technologist and/or a medical physicist)
that will be utilized by the physician or
qualified health professional for the
other four services (CPT codes 7XX02,
7XX03, 7XX04, and 7XX05) in this code
family.
We are proposing the RUCrecommended work RVU of 0.60 for
CPT code 7XX02, the work RVU of 0.76
for CPT code 7XX03, the work RVU of
0.75 for CPT code 7XX04, and the work
RVU of 0.60 for CPT code 7XX05.
We are proposing the following
refinements to the direct PE inputs. For
CPT codes 7XX00, 7XX01, 7XX02,
7XX04, and 7XX05, we are proposing to
refine the clinical labor for the CA034
activity (Document procedure
(nonPACS) (e.g., mandated reporting,
registry logs, EEG file, etc.)) performed
by the MRI Technologist from 2 minutes
to 1 minute. We note that the clinical
labor for the CA032 activity (Scan exam
documents into PACS. Complete exam
in RIS system to populate images into
work queue.) included in the direct PE
inputs for reference CPT code 70543
(Magnetic resonance (e.g., proton)
imaging, orbit, face, and/or neck;
without contrast material(s), followed by
contrast material(s) and further
sequences) is a similar clinical labor
activity and has 1 minute of time. We
also note that the Medical Physicist has
1 minute of recommended clinical labor
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61649
time for the CA034 activity for CPT code
7XX03. Therefore, we believe that the
MRI Technologist should have the same
time (1 minute) for the CA034 activity
for the remaining codes in the family to
maintain consistency across these
services.
For CPT code 7XX01, we are
proposing to refine the clinical labor for
the CA021 activity (Perform procedure/
service—NOT directly related to
physician work time) from 27 minutes to
14 minutes. We believe this clinical
labor time should be double the 7
minutes assigned to the CA021 activity
for CPT code 7XX00. The description
for CPT code 7XX00 is for the ‘‘initial
15 minutes’’ and CPT code 7XX01 is for
‘‘each additional 30 minutes,’’ that is,
double the time of CPT code 7XX00. We
believe that the clinical labor associated
with the CA021 activity should match
this pattern in which CPT code 7XX01
contains double the time of CPT code
7XX00. This proposed refinement to the
CA021 clinical labor also results in a
proposed decrease to the equipment
time for the Technologist PACS
workstation (ED050) from 45 minutes to
32 minutes.
For CPT code 7XX03, the RUC
recommended 13 minutes of equipment
time for the Professional PACS
Workstation (ED053) listed as a Facility
PE input. We believe this was an
unintended technical error and we are
proposing to remove this time from the
direct PE inputs for CPT code 7XX03.
For CPT codes 7XX04 and 7XX05, we
proposing to refine the clinical labor
time for the CA024 activity (Clean
room/equipment by clinical staff) from
2 minutes to 1 minute. According to the
PE recommendations, only the new
equipment code EQ412 (Vitals
monitoring system (MR Conditional)) is
being cleaned and not the entire room.
We believe that 1 minute of clinical
labor time would be typical for cleaning
the EQ412 equipment. Our proposed
clinical labor refinement also results in
a proposed decrease to the equipment
time for EL008 (room, MR) and EQ412
by 1 minute for these two codes.
For CPT code 7XX05, we are
proposing to remove supply item SL082
(impression material, dental putty (per
bite block)). We believe this was an error
since the PE recommendations did not
list SL082 as one of the included
supplies for CPT code 7XX05 and it
does not appear as a supply input for
any of the other codes in the family.
(15) Screening Virtual Colonoscopy
(CPT Code 74263)
As discussed in section III.K. of this
proposed rule, we are proposing to
exercise our authority at section
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1861(pp)(1)(D) of the Act to update and
expand coverage for colorectal cancer
screening and adding coverage for the
computed tomography colonography
procedure. Accordingly, we are
assigning an active payment status for
CPT code 74263 (Computed
tomographic (ct) colonography,
screening, including image
postprocessing). We note that, as
proposed above, the OPPS cap would
apply to this code, and payment for the
TC of this service would be capped at
the OPPS payment rate.
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(16) Ultrasound Elastography (CPT
Codes 76981, 76982, and 76983)
This code family was flagged for rereview at the April 2023 RUC meeting
by the new technology/new services
screen. Due to increased utilization of
CPT code 76981 (Ultrasound,
elastography; parenchyma (e.g., organ)),
the entire code family was resurveyed
for the September 2023 RUC meeting.
We are proposing the RUCrecommended work RVUs of 0.59, 0.59,
and 0.47 for CPT codes 76981, 76982
(Ultrasound, elastography; first target
lesion), and 76983 (Ultrasound,
elastography; each additional target
lesion (List separately in addition to
code for primary procedure)),
respectively. We are proposing the RUCrecommended direct PE inputs for CPT
codes 76981, 76982, and 76983 without
refinement.
(17) CT Guidance Needle Placement
(CPT Code 77012)
CPT code 77012 (Computed
tomography guidance for needle
placement (e.g., biopsy, aspiration,
injection, localization device),
radiological supervision and
interpretation) was reviewed at the
September 2023 RUC meeting to
account for deferred updates to the
vignette to reflect the typical patient
until updated utilization data was
available to reflect coding changes that
occurred in 2019. We are proposing the
RUC-recommended work RVU of 1.50
for CPT code 77012.
We are proposing to refine the
equipment time for the CT room (EL007)
to maintain the current time of 9
minutes. CPT code 77012 is a
radiological supervision and
interpretation (RS&I) procedure and
there has been a longstanding
convention in the direct PE inputs,
shared by 38 other codes, to assign an
equipment time of 9 minutes for the
equipment room in these procedures.
We made the same refinement in the CY
2019 PFS final rule (83 FR 59553
through 59554) and continue to believe
that it would not serve the interests of
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relativity to increase the equipment time
for the CT room in CPT code 77012
without also addressing the equipment
room time for the other radiological
supervision and interpretation
procedures. In response to the CY 2019
proposal, several commenters stated
that they agreed with CMS that other
RS&I codes use the 9 minutes for room
time as a precedent, but that it is
specific to angiographic rooms. We
agreed with the commenters that at least
some portion of the procedure is
performed in the CT room, but we
continue to believe that it would not
serve the interests of relativity to
increase the equipment time for the CT
room in CPT code 77012 without also
addressing the equipment room time for
the other radiological supervision and
interpretation procedures in a more
comprehensive fashion. We also
disagreed with the commenters that this
policy is specific to angiography rooms,
as CPT codes 75989 (Radiological
guidance (i.e., fluoroscopy, ultrasound,
or computed tomography), for
percutaneous drainage (e.g., abscess,
specimen collection), with placement of
catheter, radiological supervision and
interpretation) and 77012 both employ
CT rooms and currently utilize the
standardized 9 minutes of equipment
time, and CPT code 76080 (Radiologic
examination, abscess, fistula or sinus
tract study, radiological supervision and
interpretation) employs a radiographicfluoroscopic room with the 9 minute
standard equipment time. We continue
to believe that 9 minutes for EL007 is
appropriate for this RS&I code,
therefore, we are proposing to maintain
the current equipment room time of 9
minutes for EL007 until this group of
procedures can be subject to a more
comprehensive review. We are
proposing all other RUC-recommended
direct PE inputs for CPT code 77012.
(18) Telemedicine Evaluation and
Management (E/M) Services (CPT Codes
9X075, 9X076, 9X077, 9X078, 9X079,
9X080, 9X081, 9X082, 9X083, 9X084,
9X085, 9X086, 9X087, 9X088, 9X089,
9X090, and 9X091)
In February 2023, the CPT Editorial
Panel added a new Evaluation and
Management (E/M) subsection to the
draft CPT codebook for Telemedicine
Services. The Panel added 17 codes for
reporting telemedicine E/M services:
CPT code 9X075 (Synchronous audiovideo visit for the evaluation and
management of a new patient, which
requires a medically appropriate history
and/or examination and straightforward
medical decision making. When using
total time on the date of the encounter
for code selection, 15 minutes must be
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met or exceeded.); CPT code 9X076
(Synchronous audio-video visit for the
evaluation and management of a new
patient, which requires a medically
appropriate history and/or examination
and low medical decision making.
When using total time on the date of the
encounter for code selection, 30 minutes
must be met or exceeded.); CPT code
9X077 (Synchronous audio-video visit
for the evaluation and management of
a new patient, which requires a
medically appropriate history and/or
examination and moderate medical
decision making. When using total time
on the date of the encounter for code
selection, 45 minutes must be met or
exceeded.); CPT code 9X078
(Synchronous audio-video visit for the
evaluation and management of a new
patient, which requires a medically
appropriate history and/or examination
and high medical decision making.
When using total time on the date of the
encounter for code selection, 60 minutes
must be met or exceeded. (For services
75 minutes or longer, use prolonged
services code 99417)); CPT code 9X079
(Synchronous audio-video visit for the
evaluation and management of an
established patient, which requires a
medically appropriate history and/or
examination and straightforward
medical decision making. When using
total time on the date of the encounter
for code selection, 10 minutes must be
met or exceeded.); CPT code 9X080
(Synchronous audio-video visit for the
evaluation and management of an
established patient, which requires a
medically appropriate history and/or
examination and low medical decision
making. When using total time on the
date of the encounter for code selection,
20 minutes must be met or exceeded.);
CPT code 9X081 (Synchronous audiovideo visit for the evaluation and
management of an established patient,
which requires a medically appropriate
history and/or examination and
moderate medical decision making.
When using total time on the date of the
encounter for code selection, 30 minutes
must be met or exceeded.); CPT code
9X082 (Synchronous audio-video visit
for the evaluation and management of
an established patient, which requires a
medically appropriate history and/or
examination and high medical decision
making. When using total time on the
date of the encounter for code selection,
40 minutes must be met or exceeded.);
CPT code 9X083 (Synchronous audioonly visit for the evaluation and
management of a new patient, which
requires a medically appropriate history
and/or examination, straightforward
medical decision making, and more
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than 10 minutes of medical discussion.
When using total time on the date of the
encounter for code selection, 15 minutes
must be met or exceeded.)); CPT code
9X084 (Synchronous audio-only visit for
the evaluation and management of a
new patient, which requires a medically
appropriate history and/or examination,
low medical decision making, and more
than 10 minutes of medical discussion.
When using total time on the date of the
encounter for code selection, 30 minutes
must be met or exceeded.)); CPT code
9X085 (Synchronous audio-only visit for
the evaluation and management of a
new patient, which requires a medically
appropriate history and/or examination,
moderate medical decision making, and
more than 10 minutes of medical
discussion. When using total time on the
date of the encounter for code selection,
45 minutes must be met or exceeded.);
CPT code 9X086 (Synchronous audioonly visit for the evaluation and
management of a new patient, which
requires a medically appropriate history
and/or examination, high medical
decision making, and more than 10
minutes of medical discussion. When
using total time on the date of the
encounter for code selection, 60 minutes
must be met or exceeded. (For services
75 minutes or longer, use prolonged
services code 99417)); CPT code 9X087
(Synchronous audio-only visit for the
evaluation and management of an
established patient, which requires a
medically appropriate history and/or
examination, straightforward medical
decision making, and more than 10
minutes of medical discussion. When
using total time on the date of the
encounter for code selection, 10 minutes
must be exceeded.)); CPT code 9X088
(Synchronous audio-only visit for the
evaluation and management of an
established patient, which requires a
medically appropriate history and/or
examination, low medical decision
making, and more than 10 minutes of
medical discussion. When using total
time on the date of the encounter for
code selection, 20 minutes must be met
or exceeded.)); CPT code 9X089
(Synchronous audio-only visit for the
evaluation and management of an
established patient, which requires a
medically appropriate history and/or
examination, moderate medical
decision making, and more than 10
minutes of medical discussion. When
using total time on the date of the
encounter for code selection, 30 minutes
must be met or exceeded.)) CPT code
9X090 (Synchronous audio-only visit for
the evaluation and management of an
established patient, which requires a
medically appropriate history and/or
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examination, high medical decision
making, and more than 10 minutes of
medical discussion. When using total
time on the date of the encounter for
code selection, 40 minutes must be met
or exceeded. (For services 55 minutes or
longer, use prolonged services code
99417)); CPT code 9X091 (Brief
communication technology-based
service (e.g., virtual check-in) by a
physician or other qualified health care
professional who can report evaluation
and management services, provided to
an established patient, not originating
from a related evaluation and
management service provided within
the previous 7 days nor leading to an
evaluation and management service or
procedure within the next 24 hours or
soonest available appointment, 5–10
minutes of medical discussion)).
In April 2023, the AMA–RUC noted
that the survey instrument they used to
develop valuation recommendations for
the telemedicine E/M codes did not
include the time (when time is used for
code selection) in the new telemedicine
E/M services descriptors, or the E/M
services displayed on the reference
service list. The AMA–RUC made
interim valuation recommendations and
conducted a new survey for September
2023, which included the minimum
required times in the code descriptors,
and those minimum times were the
same as appear in existing O/O E/M
services code descriptors (CPT codes
99202–99205, 99212–99215); the new
survey in September 2023 included
code descriptors and times approved by
the CPT Editorial Panel in May 2023.
Also, additional specialties who
perform E/M services participated in the
second round of this survey. For CY
2025, the RUC recommended the
following work RVUs: a work RVU of
0.93 for CPT code 9X075, a work RVU
of 1.6 for CPT code 9X076, a work RVU
of 2.6 for CPT code 9X077, a work RVU
of 3.50 for CPT code 9X078, a work RVU
of 0.70 for CPT code 9X079, a work RVU
of 1.30 for CPT code 9X080, a work RVU
of 1.92 for CPT code 9X081, a work RVU
of 2.60 for CPT code 9X082, a work RVU
of 0.90 for CPT code 9X083, a work RVU
of 1.60 for CPT code 9X084, a work RVU
of 2.42 for CPT code 9X085, a work RVU
of 3.20 for CPT code 9X086, a work RVU
of 0.65. for CPT code 9X087, a work
RVU of 1.20 for CPT code 9X088.
In April 2023, the AMA–RUC Practice
Expense Subcommittee approved the
direct practice expense inputs as
recommended by the specialty societies
without modification, and CMS
received these inputs as
recommendations from the RUC. The
specialty societies detailed their
methodology for making some changes
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to specific clinical activity codes to
adapt those clinical activity codes for
telemedicine. The AMA edited both
CA009 and CA013. The AMA revision
to CA009 deletes, ‘‘greet patient,
provide gowning’’; the AMA revision to
CA013 deletes, ‘‘Prepare room,
equipment and supplies’’. CA009 now
reads, ‘‘Ensure appropriate medical
records are available’’ and CA013 now
reads, ‘‘Prepare patient for the visit (i.e.,
check audio and/or visual’’. The RUC,
using the Practice Expense
subcommittee recommendations, also
recommended to CMS that a camera and
microphone ‘‘should be considered
typical in the computer contained in the
indirect overhead expense.’’ This
determination is consistent with CMS’
longstanding position that items that are
not specifically attributable to the
individual services should not be
included for valuation of specific codes.
The AMA–RUC recommended the
direct practice expense inputs as
submitted by the AMA-member
specialty societies, and as affirmed by
the AMA–RUC Practice Expense
Subcommittee. All supply and
equipment costs were zeroed out from
the reference services, and as a result,
the new telemedicine E/M codes did not
include any supply or equipment costs
in the recommended direct practice
expense inputs that the AMA submitted
to CMS. The direct PE inputs removed
from the reference services to create the
new telemedicine E/M codes are: CA010
(obtain vital signs), CA024 (clean room/
equipment by clinical staff), SA047
(pack, EM visit), SM022 sanitizing
cloth-wipe (surface, instruments,
equipment), EQ189 (otoscopeophthalmoscope [wall unit]), EF048
(Portable stand-on scale), and EF023
(table, exam).
Sixteen of the telemedicine E/M codes
describe use of either audio-video or
audio-only telecommunications
technology to furnish the individual
service. The CPT Editorial Panel
finalized eight codes for synchronous
audio-video services (CPT codes 9X075
to 9X082), and eight codes for
synchronous audio-only services (CPT
codes 9X083 to 9X0890), and one code
for an asynchronous service (CPT code
9X091). The audio-video and audio-only
code family subsets have parallel codes
for new patients and established
patients. Like other E/M codes, these
codes may be reported based on the
level of medical decision making
(MDM) or total time on the date of the
encounter. For each set of four codes,
there is a code that may be reported for
a straightforward, low, moderate and
high level of MDM.
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The CPT Editorial Panel also
established new CPT code 9X091
describing a brief virtual check-in
encounter that is intended to evaluate
the need for a more extensive visit (that
is, a visit described by one of the office/
outpatient E/M codes). The code
descriptor for CPT code 9X091 mirrors
existing HCPCS code G2012 (Brief
communication technology-based
service, e.g., virtual check-in, by a
physician or other qualified health care
professional who can report evaluation
and management services, provided to
an established patient, not originating
from a related e/m service provided
within the previous 7 days nor leading
to an e/m service or procedure within
the next 24 hours or soonest available
appointment; 5–10 minutes of medical
discussion) and, per the CPT Editorial
Panel materials, is intended to replace
that code. As described in CPT Editorial
Panel final edits, CPT code 9X091 does
not require the use of audio or video
technology and is expected to be
patient-initiated. Furnishing the
complete service described by CPT code
9X091 must involve 5–10 minutes of
medical discussion (and the code
descriptor does not include MDM as
means of code selection). CPT code
9X091 should not be reported if it
originates from a related E/M service
furnished within the previous 7 days,
or, if the clinical interaction leads to
another E/M or procedure within the
next 24 hours or the soonest available
appointment. The final CPT Editorial
Panel draft language explains that if the
virtual check-in described by CPT
9X091 leads to an E/M visit in the next
24 hours, and if that E/M is reported
based on time, then the time from the
virtual check-in may be added to the
time of the resulting E/M visit to
determine the total time on the date of
encounter for the resulting E/M. The
RUC recommended a work RVU of 0.30
for 9X091.
The CPT Editorial Panel also deleted
three codes (99441–99443) for reporting
telephone E/M services. We note that
CPT codes 99441, 99442, and 99443,
each are assigned provisional status on
the Medicare telehealth services list,
and would return to bundled status
when the telehealth flexibilities expire
on December 31, 2024. For further
background, we refer readers to our
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discussions in previous rulemaking,
where CMS explains the rationale for
this policy (88 FR 78871–78878).
CMS has a long-standing
interpretation of section 1834(m) of the
Act as specifying the circumstances
under which Medicare makes payment
for services that would otherwise be
furnished in person but are instead
furnished via telecommunications
technology. Specifically, section
1834(m)(2)(A) of the Act expressly
requires payment to the distant site
physician or practitioner of an amount
equal to the amount that such physician
or practitioner would have been paid
had such service been furnished
without the use of a
telecommunications system. This means
that we must pay an equal amount for
a service furnished using a
‘‘telecommunications system’’ as for a
service furnished in person (without the
use of a telecommunications system). In
the CY 2019 PFS final rule, we stated
that ‘‘[w]e have come to believe that
section 1834(m) of the Act does not
apply to all kinds of physicians’ services
whereby a medical professional
interacts with a patient via remote
communication technology. Instead, we
believe that section 1834(m) of the Act
applies to a discrete set of physicians’
services that ordinarily involve, and are
defined, coded, and paid for as if they
were furnished during an in-person
encounter between a patient and a
health care professional’’ (83 FR 59483).
Under this interpretation, services that
are coded and valued based on the
understanding that they are not
ordinarily furnished in person, such as
remote monitoring services and
communication technology-based
services, are not considered Medicare
telehealth services under section
1834(m) of the Act and thus not subject
to the geographic, site of service, and
practitioner restrictions included
therein.
Information provided to CMS from
the RUC indicates that CPT codes
9X075–9X090 describe services that
would otherwise be furnished in person,
and as such the services described by
these codes are subject to section
1834(m) of the Act. In the summary of
the coding changes, the AMA states that
these services are ‘‘patterned after the
in-person office visit codes.’’ The draft
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CPT prefatory language states that
‘‘[t]elemedicine services are used in lieu
of an in-person service when medically
appropriate to address the care of the
patient and when the patient and/or
family/caregiver agree to this format of
care.’’ The draft CPT prefatory language
likewise states that when a telemedicine
E/M is billed on the same day as another
E/M service ‘‘the elements and time of
these services are summed and reported
in aggregate, ensuring that any
overlapping time is only counted once,’’
which indicates that the work of the
telemedicine E/M service is identical to
the work associated with an in-person,
non-telehealth E/M. The code
descriptors and requirements for billing
the codes generally mirror the existing
office/outpatient E/M codes with the
exception of the technological modality
used to furnish the service. The audiovideo telemedicine E/M codes have
nearly identical recommended work
RVUs to parallel office/outpatient E/M
codes. In general, the audio-only
telemedicine E/M codes have lower
recommended work RVUs than parallel
office/outpatient E/M codes. The RUC
stated that this is because, when
surveyed, specialty societies indicated
that ‘‘the audio-video and in-person
office visits require more physician
work than the audio-only office visits.’’
Table 10 describes the similarities
between 16 of 17 telemedicine E/M
codes and the parallel office/outpatient
E/M codes. The table shows that except
for the element of ‘‘modality’’ (that is,
audio-video or audio-only), the service
elements of the new telemedicine E/M
code family are no different than the O/
O E/M codes (for each enumerated row
1 through 16 the columns display the
analogous elements). When comparing
code descriptors, as described at the
start of this section, the only difference
(as represented in Table 10 when
comparing the elements of E/M services
represented by columns C, D, E, and F)
is that these new telemedicine E/M code
descriptors lead with the phrase
‘‘synchronous audio-video’’ or
‘‘synchronous audio only’’ before
describing the visit in full exactly as the
existing office/outpatient E/M visit
codes describe a visit in the long
descriptor of the analogous service.
BILLING CODE P
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TABLE 10: Comparison of Elements and Work RVU between Telemedicine E/M
Codes (9X075 through 9X090) and Office/Outpatient E/M Codes (99202 through 99215)
F
G
H
New or
Established
Patient?
Current
Work
RVU
new
Analogous
Current
Office/Out
patient
E/MCode
99202
30
new
99203
1.60
Moderate
45
new
99204
2.60
AN
High
60
new
99205
3.50
0.70
AN
Straightforward
10
established
99212
0.70
9X080
1.30
AN
Low
20
established
99213
1.30
7
9X081
1.92
AN
Moderate
30
established
99214
1.92
8
9X082
2.60
AN
High
40
established
99215
2.80
9
9X083
0.90
Straightforward
15
new
99202
0.93
10
9X084
1.60
Low
30
new
99203
1.60
11
9X085
2.42
Moderate
45
new
99204
2.60
12
9X086
3.20
High
60
new
99205
3.50
13
9X087
0.65
Straightforward
10
established
99212
0.70
14
9X088
1.20
Low
20
established
99213
1.30
15
9X089
1.75
Moderate
30
established
99214
1.92
16
9X090
2.60
Audioonlv
Audioonly
Audioonlv
Audioonly
Audioonlv
Audioonly
Audioonlv
Audioonly
High
40
established
99215
2.80
B
C
Tele medicine
E/MHCPCS
RUCrecommended
WorkRVU
Modality
1
9X075
0.93
AudioNi
deo (AN)
Straightforward
15
2
9X076
1.60
AN
Low
3
9X077
2.60
AN
4
9X078
3.50
5
9X079
6
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BILLING CODE C
There are services already describing
audio-video and audio-only
telemedicine E/M codes on the
Medicare telehealth services list—the
office/outpatient E/M code set—that can
be furnished via synchronous two-way,
audio/video communication technology
generally and via audio-only
communication technology under
certain circumstances to furnish
Medicare telehealth services in the
patient’s home for the purpose of
diagnosis and treatment of a mental
health disorder or SUD. Additionally, as
stated above, section 1834(m)(2)(A) of
the Act requires us to pay an equal
amount for a service furnished using a
‘‘telecommunications system’’ as for a
service furnished in person (without the
use of a telecommunications system).
Were we to accept the AMA’s
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D
E
Level of Medical
Time
DecisionThreshold
Making
(minutes)
recommendations and add the
telemedicine E/M codes to the Medicare
telehealth services list, we would need
to establish RVUs for the telemedicine
E/M codes to equal the corresponding
non-telehealth services to satisfy the
requirements for payment under section
1834(m)(2)(A) of the Act.
We do not believe that there is a
programmatic need to recognize the
audio/video and audio-only
telemedicine E/M codes for payment
under Medicare. We are proposing to
assign CPT codes 9X075–9X090 a
Procedure Status indicator of ‘‘I’’,
meaning that there is a more specific
code that should be used for purposes
of Medicare, which in this case would
be the existing office/outpatient E/M
codes currently on the Medicare
telehealth services list when billed with
the appropriate POS code to identify the
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0.93
location of the beneficiary and, when
applicable, the appropriate modifier to
identify the service as being furnished
via audio-only communication
technology.
Section 4113 of the Consolidated
Appropriations Act (CAA), 2023
extended the availability of Medicare
telehealth services to beneficiaries
regardless of geographic location or site
of service by temporarily removing such
statutory restrictions under section
1834(m) of the Act until the end of
2024. Under the current statute, the
geographic location and site of service
restrictions on Medicare telehealth
services will once again take effect for
services furnished beginning January 1,
2025. Although there are some
important exceptions, including for
behavioral health services and ESRDrelated clinical assessments, most
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Medicare telehealth services will once
again, in general, be available only to
beneficiaries in rural areas and only
when the patient is located in certain
types of medical settings. As previously
discussed, the introduction of new CPT
coding to describe telemedicine E/M
services does not change our authority
to pay for visits furnished through
interactive communications technology
in accordance with section 1834(m) of
the Act. We recognize that there are
significant concerns about maintaining
access to care through the use of
Medicare telehealth services with the
expiration of the statutory flexibilities
that were successively extended by
legislation following the PHE for
COVID–19. We understand that millions
of Medicare beneficiaries have utilized
interactive communications technology
for visits with practitioners for a broad
range of health care needs for almost 5
years. We are seeking comment from
interested parties on our understanding
of the applicability of section 1834(m) of
the Act to the new telemedicine E/M
codes, and how we might potentially
mitigate negative impact from the
expiring telehealth flexibilities, preserve
some access, and assess the magnitude
of potential reductions in access and
utilization. On the latter point, we note
that we have developed proposed PFS
payment rates for CY 2025, including
the statutory budget neutrality
adjustment, based on the presumption
that changes in telehealth utilization
will not affect overall service utilization.
We also note that historically we have
not considered changes in the Medicare
telehealth policies to result in
significant impact on utilization such
that a budget neutrality adjustment
would be warranted. However, we are
unsure of the continuing validity of that
premise under the current
circumstances where patients have
grown accustomed over several years to
broad access to services via telehealth.
We are seeking comment on what
impact, if any, the expiration of the
current flexibilities would be expected
to have on overall service utilization for
CY 2025. We refer readers to section
IV.B. of this proposed rule for our
discussion of budget neutrality
adjustments.
Given the similarity between CPT
code 9X091 and HCPCS code G2012, we
are proposing to accept the RUCrecommended values for CPT code
9X091, and we are proposing to delete
HCPCS code G2012. For CPT code
9X091, we propose to accept the RUCrecommended work RVU of 0.30, and
are proposing the RUC-recommended
direct PE inputs. We note that our
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proposal does maintain the same direct
PE inputs, which the RUC
recommendations leave unchanged from
the current G2012 in total amount, and
allocate the same 3 minutes of time to
the same level of staff (Clinical Staff
code L037D, RN/LPN/MTA). We believe
that the coding and payment
recommendations for CPT code 9X091,
submitted to CMS by the AMA RUC,
accurately reflect the resources
associated with this service and believe
that maintaining separate coding for
purposes of Medicare payment could
create confusion. We note that, similar
to our current policy for payment of
HCPCS code G2012, CPT code 9X091
would be considered a communication
technology-based service that is not
subject to the requirements in section
1834(m) of the Act applicable to
Medicare telehealth services.
(19) Genetic Counseling Services (CPT
Code 9X100)
In September 2023, the CPT Editorial
Panel deleted CPT code 96040 (Medical
genetics and genetic counseling
services, each 30 minutes face-to-face
with patient/family) and created CPT
code 9X100 (Medical genetics and
genetic counseling services, each 30
minutes of total time provided by the
genetic counselor on the date of the
encounter) for medical genetics and
genetic counseling services to be
provided by the genetic counselor. Prior
to its deletion, CPT code 96040 would
only be reported by genetic counselors
for genetic counseling services, though
genetic counselors are not among the
practitioners who can bill Medicare
directly for their professional services.
As we stated in the CY 2012 PFS final
rule (76 FR 73096 through 73097),
physicians and NPPs who may
independently bill Medicare for their
services and who are counseling
individuals would generally report
office or other outpatient E/M CPT
codes for office visits that involve
significant counseling, including genetic
counseling; therefore CPT code 96040
was considered bundled into O/O E/M
visits.
For CPT code 9X100, we are
proposing the RUC-recommended direct
PE inputs. We note that the code
descriptor now specifies that the service
is provided by a genetic counselor,
therefore we considered assigning
Procedure Status ‘‘X’’ to CPT code
9X100. Because the PE RVUs would not
display for the code with that
assignment and that may impact access
to the service with other payors, we are
instead proposing bundled status
(Procedure Status ‘‘B’’) for CPT code
9X100 to maintain the status of
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predecessor CPT code 96040, and we
are seeking feedback from interested
parties regarding the appropriate
procedure status for this code. CPT
guidelines for CPT code 9X100 state that
a physician or other qualified healthcare
professional (QHP) who may report
evaluation and management services
would not be able to report CPT code
9X100. Instead, these physicians and
QHPs would use the appropriate
evaluation and management code.
(20) COVID Immunization
Administration (CPT Code 90480)
On August 14, 2023, new CPT codes
were created to consolidate over 50
previously implemented codes and
streamline the reporting of
immunizations for the novel
coronavirus (SARS-CoV–2, also known
as COVID–19). The CPT Editorial Panel
approved the addition of a single
administration code (CPT code 90480)
for administration of new and existing
COVID–19 vaccine products. The RUC
reviewed the specialty societies’
recommendations for this code at the
September 2023 RUC meeting.
We are proposing the RUCrecommended work RVU of 0.25 for
CPT code 90480 (Immunization
administration by intramuscular
injection of severe acute respiratory
syndrome coronavirus 2 (SARS–CoV–2)
(coronavirus disease [COVID–19])
vaccine, single dose). We are also
proposing the RUC-recommended direct
PE inputs for CPT code 90480 without
refinement.
(21) Optical Coherence Tomography
(CPT Codes 92132, 92133, 92134, and
9X059)
At the February 2023 CPT Editorial
Panel meeting, CPT code 9X059
(Computerized ophthalmic diagnostic
imaging (eg, optical coherence
tomography [OCT]), posterior segment,
with interpretation and report,
unilateral or bilateral; retina including
OCT angiography) was created in
response to new technology that allows
imaging of the retina using optical
coherence tomography (OCT) with and
without non-dye OCT angiography
(OCT–A). This code family also
includes CPT code 92132
(Computerized ophthalmic diagnostic
imaging (eg, optical coherence
tomography [OCT]), anterior segment,
with interpretation and report,
unilateral or bilateral), CPT code 92133
(Computerized ophthalmic diagnostic
imaging (eg, optical coherence
tomography [OCT]), posterior segment,
with interpretation and report,
unilateral or bilateral; optic nerve), and
CPT code 92134 (Computerized
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ophthalmic diagnostic imaging (eg,
optical coherence tomography [OCT]),
posterior segment, with interpretation
and report, unilateral or bilateral;
retina). These codes were reviewed at
the April 2023 RUC meeting. The RUC
determined the survey results were
inaccurate due to underestimation of
time, so the entire code family was resurveyed and reviewed at the September
2023 RUC meeting.
We are proposing the RUCrecommended work RVUs for all codes
within the Optical Coherence
Tomography code family. We are
proposing a work RVU of 0.29 for CPT
code 92132, a work RVU of 0.31 for CPT
code 92133, a work RVU of 0.32 for CPT
code 92134, and a work RVU of 0.64 for
CPT code 9X059. We are also proposing
the RUC-recommended direct PE inputs
for all four codes in the family.
(22) Transcranial Doppler Studies (CPT
Codes 93886, 93888, 93892, 93893,
93X94, 93X95, 93X96, and 93890)
The RUC’s Relativity Assessment
Workgroup (RAW) requested action
plans in September 2022 to determine if
specific code bundling solutions should
occur for CPT codes 93890/93886,
93890/93892, 93892/93886, and 93892/
93890. The RAW referred this issue to
the CPT Editorial Panel which created
three new add-on codes to report when
additional studies are performed on the
same date of services as a complete
transcranial Doppler study. The RUC
reviewed these three new add-on codes,
as well as CPT codes 93886, 93888,
93892 and 93893 for the September
2023 RUC meeting.
We are proposing the RUCrecommended work RVU for all seven
codes in the Transcranial Doppler
Studies code family. We are proposing
a work RVU of 0.90 for CPT code 93886
(Transcranial Doppler study of the
intracranial arteries; complete study), a
work RVU of 0.73 for CPT code 93888
(Transcranial Doppler study of the
intracranial arteries; limited study), a
work RVU of 1.15 for CPT code 93892
(Transcranial Doppler study of the
intracranial arteries; emboli detection
without intravenous microbubble
injection), a work RVU of 1.15 for CPT
code 93893 (Transcranial Doppler study
of the intracranial arteries; venousarterial shunt detection with
intravenous microbubble injection), a
work RVU of 0.81 for CPT code 93X94
(Vasoreactivity study performed with
transcranial Doppler study of
intracranial arteries, complete), a work
RVU of 0.73 for CPT code 93X95
(Emboli detection without intravenous
microbubble injection performed with
transcranial Doppler study of
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intracranial arteries, complete), and a
work RVU of 0.85 for CPT code 93X96
(Venous-arterial shunt detection with
intravenous microbubble injection
performed with transcranial Doppler
study of intracranial arteries, complete).
We are also proposing the direct PE
inputs as recommended by the RUC for
all seven codes in this family.
We note that the billing instructions
for this code family specify that the
three new add-on codes should be used
in conjunction with CPT code 93886,
and that CPT code 93888 should not be
used in conjunction with CPT codes
93886, 93892, 93893, 93X94, 93X95,
and 93X96. However, we believe that it
would be beneficial for the CPT
Editorial Panel to state more explicitly
that CPT code 93X95 should not be used
in conjunction with CPT code 93892
and that CPT code 93X96 should not be
used in conjunction with CPT code
93893. The work performed in the addon codes would be duplicative of the
base codes in these situations and result
in unnecessary overbilling of services.
(23) RSV Monoclonal Antibody
Administration (CPT Codes 96380 and
96381)
At the September 2023 CPT meeting,
the CPT Editorial Panel created two
codes to report passive administration
of respiratory syncytial virus,
monoclonal antibody, seasonal dose,
with and without counseling. CPT codes
96380 and 96381 were reviewed the
following week at the September 2023
RUC meeting and the RUC submitted
recommendations to CMS.
We are proposing the RUCrecommended work RVU of 0.24 for
CPT code 96380 (Administration of
respiratory syncytial virus, monoclonal
antibody, seasonal dose by
intramuscular injection, with counseling
by physician or other qualified health
care professional) and the RUCrecommended work RVU of 0.17 for
CPT code 96381 (Administration of
respiratory syncytial virus, monoclonal
antibody, seasonal dose by
intramuscular injection). We
understand that these are interim work
recommendations from the RUC, and
that the RUC intends to conduct a more
complete review at a future RUC
meeting which we would then consider
in future rulemaking. We are also
proposing the direct PE inputs as
recommended by the RUC for both
codes.
(24) Hyperthermic Intraperitoneal
Chemotherapy (CPT Codes 96547 and
96548)
In September 2022, the CPT Editorial
Panel created two time-based add-on
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Category I codes, CPT code 96547
(Intraoperative hyperthermic
intraperitoneal chemotherapy (HIPEC)
procedure, including separate
incision(s) and closure, when
performed; first 60 minutes (List
separately in addition to code for
primary procedure)) and CPT code
96548 (Intraoperative hyperthermic
intraperitoneal chemotherapy (HIPEC)
procedure, including separate
incision(s) and closure, when
performed; each additional 30 minutes
(List separately in addition to code for
primary procedure)), to report HIPEC
procedures for 2024. At the January
2023 RUC meeting, the RUC reached the
conclusion that the survey data was
flawed due to a lack of work definition
and guidelines, and the RUC
recommended contractor pricing for
CPT codes 96547 and 96548 for CY 2024
with further clarification from the CPT
editorial panel. CMS proposed and
finalized contractor pricing for CPT
codes 96547 and 96548 for 2024. At the
May 2023 CPT Editorial Panel meeting,
new guidelines and descriptions of
work activities were approved and the
codes were resurveyed for the
September 2023 RUC meeting with
recommendations for national pricing.
We are proposing the RUCrecommended work RVU of 6.53 for
CPT code 96547 and the RUCrecommended work RVU of 3.00 for
CPT code 96548. The RUC did not
recommend, and we are not proposing,
any direct PE inputs for the
Hyperthermic Intraperitoneal
Chemotherapy codes (CPT codes 96547
and 96548).
(25) Laser Treatment—Skin (CPT Codes
96920, 96921, and 96922)
In April 2022, the RUC referred CPT
codes 96920 (Excimer laser treatment
for psoriasis; total area less than 250 sq
cm), 96921 (Excimer laser treatment for
psoriasis; 250 sq cm to 500 sq cm), and
96922 (Excimer laser treatment for
psoriasis; over 500 sq cm) to the CPT
Editorial Panel to capture expanded
indications beyond what was currently
noted in the codes’ descriptions to
include laser treatment for other
inflammatory skin disorders such as
vitiligo, atopic dermatitis, and alopecia
areata, which could result in changed
physician work based on the expanded
indications. The coding change
application was subsequently
withdrawn from the September 2023
CPT Editorial meeting when it was
determined that existing literature was
insufficient and did not support
expanded indications at that time.
Therefore, these CPT codes were resurveyed and reviewed at the April
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2023 RUC meeting without any
revisions to their code descriptors.
We disagree with the RUCrecommended work RVUs for CPT
codes 96920, 96921, and 96922 of 1.00,
1.07, and 1.32, respectively. The RUC
noted that there have been multiple
reviews of these CPT codes, and the
valuation of the codes is currently based
on the original valuation over two
decades ago in 2002 where the
physician time values were lower than
the current times. A subsequent review
in 2012 adopted new survey times while
maintaining the work RVUs from 2002
for CPT codes 96920 and 96922. The
RUC noted that, for both CPT code
96920 and 96922 with the largest
treatment area, the total times have not
changed since first implemented more
than 20 years ago. While we understand
that the physician times have fluctuated
over the course of several years and
several reviews, yet the work RVUs have
remained mostly constant as shown in
Table 11, this was not addressed in the
2012 recommendations, and we believe
that our operating assumption regarding
the validity of the existing values as a
point of comparison is critical to the
integrity of the relative value system as
currently constructed. The work times
currently associated with codes play a
very important role in PFS ratesetting,
both as points of comparison in
establishing work RVUs and in the
allocation of indirect PE RVUs by
specialty. If we were to operate under
the assumption that previously
recommended work times had been
routinely over or underestimated, this
would undermine the relativity of the
work RVUs on the PFS in general, in
light of the fact that codes are often
valued based on comparisons to other
codes with similar work times. We also
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.
TABLE 11: Physician Time and RVUs for CPT Codes 96920, 96921, and 96922
96920
96921
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96922
Total Time
17
23
10
20
30
12
30
45
18
27
35
23
30
42
25
40
57
31
2002
Current (from 2012)
Recommended
2002
Current (from 2012)
Recommended
2002
Current (from 2012)
Recommended
For CPT code 96920, we are
proposing a work RVU of 0.83 based on
a crosswalk to CPT code 11104 (Punch
biopsy of skin (including simple closure,
when performed); single lesion), which
has the same 10 minutes of intraservice
time and 23 minutes of total time as
CPT code 96920. We note that of the 15
other 000-day global codes with a total
time of 20 to 25 minutes, only four
codes fall above the RUC-recommended
work RVU of 1.00. While we understand
that commenters will dispute the
validity of the current time values, we
note that the 2002 intraservice time was
17 minutes, which yields an intraservice
time ratio between the 2002 intraservice
time and the recommended intraservice
time of 10 minutes of 0.68 work RVUs
((10 minutes/17 minutes) * 1.15). We
note our proposed work RVU of 0.83
maintains the intensity associated with
the 2002 review of CPT code 96920,
which we believe to be more
appropriate than the significant increase
in intensity that results from the RUCrecommended work RVU of 1.00 which
nearly doubles the current intensity of
the code. We have no evidence to
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RUC
Recommended Work
RVU
1.15
1.15
1.00
1.17
1.30
1.07
2.10
2.10
1.32
indicate that the intensity of CPT code
96920 is increasing to this degree given
how the surveyed work time is
substantially decreasing.
For CPT code 96921, we are
proposing a work RVU of 0.90 based on
a total time ratio to CPT code 96920
((25/23) * 0.83) and a crosswalk to CPT
code 11301 (Shaving of epidermal or
dermal lesion, single lesion, trunk, arms
or legs; lesion diameter 0.6 to 1.0 cm),
which has 3 additional minutes of
intraservice time and 1 additional
minute of total time compared to CPT
code 96921. We also note that our
proposed work RVU of 0.90 for CPT
code 96921 maintains the RUCrecommended incremental difference
between CPT codes 96920 and 96921 of
0.07 work RVUs. Like CPT code 96920,
we understand that commenters will
dispute the validity of the current time
values, but we note that the 2002
intraservice time was 20 minutes, which
yields an intraservice time ratio between
the 2002 intraservice time and the
recommended intraservice time of 12
minutes of 0.70 work RVUs ((12
minutes/20 minutes) * 1.17). Like CPT
code 96920, we note that proposed work
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RVU of 0.90 for CPT code 96921
maintains the intensity associated with
the 2002 review of CPT code 96921,
which we believe is more appropriate
than the intensity increase that results
from the RUC-recommended work RVU
of 1.07 which again nearly doubles the
current intensity of the code.
For CPT code 96922, we are
proposing a work RVU of 1.15 based on
the RUC-recommended incremental
difference between CPT codes 96921
and 96922 of 0.25 work RVUs. Like CPT
code 96920 and 96921, we understand
that commenters will dispute the
validity of the current time values, but
we note that the 2002 intraservice time
was 30 minutes, which yields an
intraservice time ratio between the 2002
intraservice time and the recommended
intraservice time of 18 minutes of 1.26
work RVUs ((18 minutes/30 minutes) *
2.10). We note that the RUC
recommended CPT code 96922 as
having the lowest intensity of the three
codes in this family and that our
proposed work RVU of 1.15 maintains
in relationship to the other codes.
For the direct PE inputs, we are
proposing to refine the clinical staff
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time for the CA024 activity ‘‘Clean
room/equipment by clinical staff’’ to the
standard of 3 minutes for CPT codes
96920, 96921, and 96922. We note that
3 minutes is the current CA024 time for
these three CPT codes. A rationale for
extending clinical staff beyond the
standard 3 minutes for the CA024
activity was absent from the PE
Summary of Recommendations,
therefore we believe the current and
standard 3 minutes is more appropriate
than the RUC-recommended 5 minutes.
We are also proposing equipment times
of 36, 38, and 44 minutes for the power
table (EF031) and exam light (EQ168)
equipment for CPT codes 96920, 96921,
and 96922, respectively, to account for
the proposed refinement for CA024 to
the standard 3 minutes.
We also disagree with the RUCrecommended creation of new supply
items for the excimer laser and are
proposing to re-include the equipment
time for the excimer laser (EQ161) using
the current methodology where its cost
is accounted for in the equipment of
these CPT codes’ direct PE. The RUC
submitted recommendations to change
this equipment item to new supply
items to account for the per-use cost to
rent the equipment, stating that the
business model has changed from the
standard equipment ownership that
CMS recognizes using standardized
equipment formulas to a per-use rental
or subscription model. While we
understand that there may have been a
change in business model, we do not
believe a rental, subscription, or per-use
fee of an equipment item that is still
available to be purchased and is already
accounted for with our equipment
methodology is appropriate, especially
given its implications for direct PE costs
for these CPT codes. Therefore, we are
proposing reincorporating equipment
times of 36, 38, and 44 minutes for the
EQ161 equipment for CPT codes 96920,
96921, and 96922, respectively, based
on the refined service period clinical
labor times. We are proposing to remove
the three pay-per-use excimer lasers
listed as supplies and recommended by
the RUC for these three codes.
We have repeatedly stated in past
rulemaking that rental and licensing
fees are typically considered forms of
indirect PE under our methodology. In
the CY 2020 PFS final rule, we omitted
the inclusion of several invoices for the
monthly rental price of a PET infusion
cart (ER109), and only accounted for the
four purchase invoices for the
equipment. We noted as well for future
reference that although we appreciated
the submission of the rental invoices,
we were unable to use invoices for a
monthly rental fee to determine the
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typical purchase price for equipment.
We believe that invoices for a monthly
rental fee would not be representative of
the purchase price for equipment, in the
same fashion that the rental fee for a car
differs from its purchase price (84 FR
62771). Similarly, while we appreciate
the submission of per-use, rental, and
partnership invoices for the excimer
laser, we believe that the excimer laser
is appropriately and adequately
accounted for in the equipment formula,
and note that EQ161 has a very high
cost per minute of $0.5895/minute.
Compared to the nearly 700 other
equipment items in our database, only
55 equipment items have higher costs
per minute (based on our standardized
formula which accounts for years of
useful life, utilization rate, purchase
price, and minutes per year of use,
discussed in detail in section II.B. of
this proposed rule, Determination of PE
RVUs) and only 53 equipment items
have higher purchase prices than the
excimer laser at $151,200. We do not
believe that CPT codes 96920 through
96922 should be valued based on a
significantly more expensive pay-peruse rental version of the excimer laser
when the same treatment is cheaper and
available as a purchasable form of
equipment.
Therefore, we are seeking comment
on the difference in direct PE costs
between the purchase and per-use rental
of the laser. We note that using the
equipment cost per minute formula,
discussed in detail of section II.B. of this
proposed rule, Determination of PE
RVUs, yields direct PE costs of about
$21.22, $22.40, and $25.94 for CPT
codes 96920, 96921, 96922,
respectively. Alternatively, the new
supply items for the per-use fee of the
laser yielded direct PE costs of $80, $83,
and $100 for CPT codes 96920, 96921,
96922, respectively. These direct PE
disparities represent a 277 percent,
270.5 percent, and 285.5 percent
increase for CPT codes 96920, 96921,
96922, respectively. Given this, we are
interested in feedback from interested
parties on the payment disparity
between this equipment as a per-use or
rental versus how we currently account
for the purchase of equipment using the
standard equipment formula, as we
understand that both manufacturers and
physicians may be inclined to shift to a
per-use or rental business models to
limit overhead for purchase and
maintenance of expensive equipment.
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(26) Physical Medicine and
Rehabilitation (CPT Codes 97012,
97014, 97016, 97018, 97022, 97032,
97033, 97034, 97035, 97110, 97112,
97113, 97116, 97140, 97530, 97533,
97535, 97537, and 97542 and HCPCS
Code G0283)
The RUC’s Health Care Professionals
Advisory Committee (HCPAC)
previously reviewed 19 physical
medicine and rehabilitation codes in
February 2017. In the CY 2024 PFS
proposed rule, CMS received public
nominations on these same 19 therapy
codes as potentially misvalued (88 FR
78851–78852). An interested party
asserted that the direct PE clinical labor
minutes reflected inappropriate
multiple procedure payment reductions
(MPPR), which were duplicative of the
CMS MPPR policy implemented in
CMS’ claims processing systems. CMS
reviewed the clinical labor time entries
for these 19 therapy codes and
concluded that a payment reduction
should not have been applied in some
instances to the 19 nominated therapy
codes’ clinical labor time entries since
the payment valuation reduction would
be duplicative of the MPPR applied
during claims processing. CMS
indicated that the valuation of these
services would benefit from additional
review through the RUC’s HCPAC
valuation process; they were therefore
reviewed by the HCPAC for PE only,
with no work review, at the January
2024 RUC meeting for inclusion in the
CY 2025 PFS proposed rule.
The HCPAC’s direct PE
recommendations were based on the
typical number of services reported per
session, which was 3.5 units according
to CMS data, to ensure that there was no
duplication in the standard inputs for
preservice and postservice time. To
account for the MPPR, the HCPAC
determined that 3.5 codes are billed per
session, with the first paid at 100% and
the second and subsequent units paid at
half and so forth for PE (for example,
1.00 + 0.5 + 0.5 + 0.25 = 2.25). This
resulted in the HCPAC recommending
that many of the standard clinical labor
times be divided by 2.25 to account for
the MPPR, such as taking the standard
3 minutes for greeting and gowning the
patient and dividing it by 2.25 to arrive
at the recommended time of 1.33
minutes (1.33 + 0.67 + 0.67 + 0.34 = 3
minutes). In most cases, the HCPAC
recommended using the standard
equipment time formula aside from a
few exceptions such as the use of the
whirlpool in CPT code 97022 which
would require additional time for the
cleaning of the equipment.
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Following the January 2024 RUC
meeting, representatives from the
American Physical Therapy Association
(APTA) and the American Occupational
Therapy Association (AOTA) met with
CMS to express concern with the
HCPAC’s recommended direct PE
inputs for this family of codes.
Representatives from these trade
associations stated that the HCPAC had
inappropriately recommended too few
equipment minutes for these
procedures. These interested parties
requested utilizing an alternate
equipment time formula for the 19
reviewed therapy codes based on adding
together the intraservice work time
together with the clinical labor for the
preservice and postservice portion of
the service period. For 17 of the 19
reviewed therapy codes, this alternate
equipment time formula would result in
an increase over the HCPAC’s
equipment time recommendations.
Table 12 lists the direct PE costs of each
HCPCS code under their current pricing,
under the HCPAC recommendations,
and the alternate APTA and AOTA
recommendations:
TABLE 12: Direct PE Costs for Physical Medicine and Rehabilitation Codes
Current
2.62
3.60
2.94
2.29
8.04
2.61
6.61
4.08
4.03
8.42
10.23
13.89
8.35
7.25
15.01
35.72
11.50
9.69
9.26
3.60
After consideration of these
recommendations, we are proposing the
direct PE inputs as recommended by the
HCPAC for all 19 codes in the Physical
Medicine and Rehabilitation code
family. We believe that the HCPAC’s
equipment time recommendations better
maintain relativity with the rest of the
fee schedule through primarily using
standard equipment time formulas,
along with limited exceptions for
additional equipment time in cases
where more time for equipment
cleaning or patient positioning would be
typical. We also believe that the
alternate equipment time formula
recommended by APTA and AOTA
leads to inconsistent equipment times
for many of these procedures, such as
recommending 23.98 equipment
minutes for CPT code 97110 which is a
timed code billed in 15-minute
increments. Although we agree that
some additional equipment time beyond
the timed 15 minutes would be typical
for setup and cleaning, 9 additional
minutes for each billing of CPT code
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HCPAC
3.22
4.16
3.50
2.92
7.27
3.17
6.74
4.17
4.41
8.63
9.87
14.65
8.58
8.09
14.38
36.56
11.64
10.09
9.41
4.16
APTA/AOTA
3.30
4.33
3.67
2.96
7.18
3.34
6.90
4.17
4.65
9.11
11.08
14.61
9.03
8.21
16.40
36.69
12.67
10.78
10.42
4.33
97110 would not appear to reflect
typical equipment usage.
Given the complexity of determining
appropriate direct PE inputs across
multiple billings of these therapy codes,
and the need to factor in the MPPR, we
believe that this code family may benefit
from additional review, specifically
review focused on the subject of
appropriate equipment minutes. The
HCPAC review of these codes was
primarily focused on the clinical labor
portion of the PE inputs and the
equipment times did not receive the
same degree of scrutiny as the clinical
labor. We believe that the HCPAC’s
recommended direct PE inputs are the
most accurate values based on the
current information that we have
available, however this is a topic that
may warrant additional review to ensure
that this family of codes is properly
valued.
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Utilization
434.921
ProcStat "I"
876.440
146,909
135.480
621.599
33 953
6,964
1 358.936
61,204 041
24.990 205
1588,852
4 011.592
28.413 744
29.187 934
60 507
3 118.258
15 556
98 989
5 721.078
(27) Acupuncture—Electroacupuncture
(CPT Codes 97810, 97811, 97813, and
97814)
In September 2022, the RUC’s
Relativity Assessment Workgroup
identified the acupuncture codes with
2020 Medicare utilization over 10,000
where the service was surveyed by one
specialty but is now performed by a
different specialty. CPT codes 97810–
97814 were selected and surveyed for
the April 2023 RUC meeting.
For CY 2025, we are proposing the
RUC-recommended work RVUs for all
four CPT codes. We are proposing a
work RVU of 0.61 for CPT code 97810
(Acupuncture, 1 or more needles;
without electrical stimulation, initial 15
minutes of personal one-on-one contact
with the patient), a work RVU of 0.46 for
CPT code 97811 (Acupuncture, 1 or
more needles; without electrical
stimulation, each additional 15 minutes
of personal one-on-one contact with the
patient, with re-insertion of needle(s)
(List separately in addition to code for
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97012
97014
97016
97018
97022
97032
97033
97034
97035
97110
97112
97113
97116
97140
97530
97533
97535
97537
97542
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primary procedure)), a work RVU of
0.74 for CPT Code 97813 (Acupuncture,
1 or more needles; with electrical
stimulation, initial 15 minutes of
personal one-on-one contact with the
patient), and a work RVU of 0.47 for
CPT code 97814 (Acupuncture, 1 or
more needles; with electrical
stimulation, each additional 15 minutes
of personal one-on-one contact with the
patient, with re-insertion of needle(s)
(List separately in addition to code for
primary procedure)). We are also
proposing the RUC-recommended direct
PE inputs for CPT codes 97810, 97811,
97813 and 97814 without refinement.
(28) Annual Alcohol Screening (HCPCS
Codes G0442 and G0443)
In April 2022, the Relativity
Assessment Workgroup identified
services with Medicare utilization of
10,000 or more that have increased by
at least 100 percent from 2015 through
2020, including HCPCS codes G0442
(Annual alcohol misuse screening, 5 to
15 minutes) and G0443 (Brief face-toface behavioral counseling for alcohol
misuse, 15 minutes). In September 2022,
the RUC recommended that these
services be surveyed for April 2023 after
CMS published the revised code
descriptor for HCPCS code G0442 in the
CY 2023 PFS final rule (87 FR 69523).
We are proposing the RUCrecommended work RVU of 0.18 for
HCPCS code G0442 (Annual alcohol
misuse screening, 5 to 15 minutes). We
are also proposing the RUCrecommended work RVU of 0.60 for
HCPCS code G0443 (Brief face-to-face
behavioral counseling for alcohol
misuse, 15 minutes).
The RUC recommended an increase in
the work RVU for HCPCS code G0443
from 0.45 to 0.60 which we believe is
warranted based on time and intensity
of the service in preventing alcohol
misuse. In valuing this code, the time
and work valuation is for separate and
distinct services from same-day E/M
services since HCPCS codes G0442 and
G0443 are typically billed with an
annual wellness visit (AWV) or office
visit. We believe that the codes in the
adjacent Behavioral Counseling &
Therapy family, which includes HCPCS
codes G0445 (High intensity behavioral
counseling to prevent sexually
transmitted infection; face-to-face,
individual, includes: education, skills
training and guidance on how to change
sexual behavior; performed semiannually, 30 minutes), G0446 (Annual,
face-to-face intensive behavioral
therapy for cardiovascular disease,
individual, 15 minutes), and G0447
(Face-to-face behavioral counseling for
obesity, 15 minutes), may be
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undervalued as their respective
intensities may be lower than what is
warranted for these services. We believe
that the intensity for these G-codes may
be more in line with the intensity of
HCPCS code G0443 which we noted had
an increase in intensity as
recommended by the RUC. As such, we
believe that the Behavioral Counseling &
Therapy codes may benefit from
additional review in the future to
recognize the intensity of these services.
We are proposing to maintain the
current 15 minutes of clinical labor time
for the CA021 ‘‘Perform procedure/
service—NOT directly related to
physician work time’’ activity for
HCPCS code G0442. This clinical labor
activity is specifically noted as not
corresponding to the surveyed work
time of 5 minutes, and we do not
believe that it would be typical for the
clinical staff to administer the
questionnaire, clarify questions as
needed, and record the answers in the
patient’s electronic medical record in
the RUC-recommended 5 minutes. We
believe that the current 15 minutes of
clinical labor time would be more
typical to ensure the accuracy of this
screening procedure. We are also
proposing to maintain 15 minutes of
corresponding equipment time for the
EF023 exam table as a result of our
proposed clinical labor time refinement.
We are proposing the RUCrecommended direct PE inputs for
HCPCS code G0443 without refinement.
We thank the RUC for their review of
this code family and for highlighting an
important consideration specifically for
services that fall under the Medicare
preventive services benefit. We are now
considering how best to implement and
maintain payment for preventive
services and may develop new payment
policies in future rulemaking to address
this issue more comprehensively to
ensure consistent access to these
services. We considered the
recommended PE inputs for this code
family, as well as for the Annual
Depression Screening (HCPCS code
G0444) and Behavioral Counseling &
Therapy services (HCPCS codes G0445,
G0446, and G0447) within this context,
as noted below.
(29) Annual Depression Screening
(HCPCS Code G0444)
In 2012, HCPCS code G0444 (Annual
depression screening, 5 to 15 minutes)
was added to the PFS (77 FR 68955 and
68956) to report annual depression
screening for adults in primary care
settings that have staff-assisted
depression care supports in place to
assure accurate diagnosis, treatment and
follow up. In April 2022, the Relativity
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Assessment Workgroup identified this
service with Medicare utilization of
10,000 or more that have increased by
at least 100 percent from 2015 through
2020. In September 2022, the RUC
recommended that this service be
surveyed for April 2023 after CMS
published the revised code descriptor in
the CY 2023 PFS final rule (87 FR
69523).
We are proposing the RUCrecommended work RVU of 0.18 for
HCPCS code G0444.
We are proposing to maintain the
current 15 minutes of clinical labor time
for the CA021 ‘‘Perform procedure/
service—NOT directly related to
physician work time’’ activity for
HCPCS code G0444. This clinical labor
activity is specifically noted as not
corresponding to the surveyed work
time of 5 minutes, and we do not
believe that it would be typical for the
clinical staff to administer the
questionnaire, clarify questions as
needed, and record the answers in the
patient’s electronic medical record in
the RUC-recommended 5 minutes. We
believe that the current 15 minutes of
clinical labor time would be more
typical to ensure the accuracy of this
screening procedure. We are also
proposing to maintain 15 minutes of
corresponding equipment time for the
EF023 exam table as a result of our
proposed clinical labor time refinement.
(30) Behavioral Counseling & Therapy
(HCPCS Codes G0445, G0446, and
G0447)
CMS created HCPCS codes G0445
(High intensity behavioral counseling to
prevent sexually transmitted infection;
face-to-face, individual, includes
education, skills training and guidance
on how to change sexual behavior;
performed semi-annually, 30 minutes),
G0446 (Annual, face-to-face intensive
behavioral therapy for cardiovascular
disease, individual, 15 minutes), and
G0447 (Face-to-face behavioral
counseling for obesity, 15 minutes)
effective with the 2012 Medicare PFS
(77 FR 68892). HCPCS codes G0445–
G0447 were identified to be reviewed at
the April 2023 RUC meeting because
they were services with Medicare
utilization of 10,000 or more that had
increased by at least 100% from 2015
through 2020.
The specialty societies surveyed
HCPCS codes G0445–G0447 for the
April 2023 RUC meeting but did not
obtain the required number of survey
responses. After the resurvey, which
occurred after the April 2023 RUC
meeting, the specialty societies were
again unable to achieve the required
minimum number of survey responses
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for any of the codes in this family for
the September 2023 RUC meeting. The
RUC reviewed HCPCS codes G0445–
G0447 at the September 2023 RUC
meeting. Given the insufficient number
of survey responses and considering
that these are CMS-created time-based
codes, the RUC determined it would be
most appropriate to maintain the
current work values and flagged these
codes for review in 3 years. We are
proposing the RUC-recommended work
RVU of 0.45 for each of these three
HCPCS codes, G0445–G0447.
We are not proposing the RUCrecommended direct PE inputs for these
codes because of the insufficient
number of survey responses, and
further, we do not agree with some of
the RUC’s refinements to the direct PE
inputs for this service. We are not
proposing the RUC-recommended direct
PE inputs for G0445, G0446, and G0447,
which include the SK062 patient
education booklet being eliminated in
favor of the SK057 paper, laser printing
(each sheet) in the amount of 10 sheets
and the equipment minutes being
modified to equal the sum of clinical
staff time plus the physician/QHP time
as reflected by the survey median. We
do not agree that these changes are
substantiated given the insufficient
number of survey responses and we are
proposing to maintain the current
values for each of these direct PE inputs.
We are proposing the RUC
recommended refinements to clinical
staff time for HCPCS code G0445. We
are proposing to move two minutes from
CA021 Perform procedure/service—
NOT directly related to physician work
time to CA035 Review home care
instructions, coordinate visits/
prescriptions. We agree with the RUC
that this more accurately reflects the
clinical work involved in arranging
follow-up and/or referrals with clinical
and community resources and providing
educational materials. Currently, for
HCPCS code G0445, PE includes a whip
mixer (EP086) and biohazard hood
(EP016) among the equipment assigned
to the code. We are also proposing the
RUC recommendations to eliminate
both of these pieces of equipment from
the PE for HCPCS code G0445.
We note that the Behavioral
Counseling & Therapy code family
(HCPCS codes G0445–G0447) should be
reviewed in the future by the RUC and
we anticipate the recommendations that
will come from the review for this
family.
(31) Autologous Platelet Rich Plasma
(HCPCS Code G0465)
HCPCS code G0465 (Autologous
platelet rich plasma (prp) or other
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blood-derived product for diabetic
chronic wounds/ulcers, using an fdacleared device for this indication,
(includes as applicable administration,
dressings, phlebotomy, centrifugation or
mixing, and all other preparatory
procedures, per treatment)) was created
for CY 2022 (retroactively dated back to
the effective date of the policy, April 13,
2021) and assigned contractor pricing
(NCD 270.3, CR 12403).
Following the publication of the CY
2023 PFS proposed rule, we received
two comments on the pricing of HCPCS
code G0465, and the 3C patch system
supply which is topically applied for
the management of exuding cutaneous
wounds, such as leg ulcers, pressure
ulcers, and diabetic ulcers and
mechanically or surgically debrided
wounds (87 FR 69420). One commenter
submitted invoices associated with the
pricing of the 3C patch system (SD343)
supply for which we established a price
of $625.00 in the CY 2021 PFS final rule
(85 FR 84498). The commenter
requested that CMS update its supply
database based on invoices submitted
for SD343 to reflect an updated price of
$750.00 per unit. The commenter also
requested national pricing for HCPCS
code G0465, expressing concern that
insufficient payment disproportionately
impacts vulnerable populations. The
commenter requested a payment rate of
$1,408.90 for HCPCS G0465 in the office
setting, stating that this rate would
appropriately account for the purchase
of the 3C patch, as well as the other
related costs and supply inputs required
for point of care creation and
administration.
In response, we stated in the CY 2023
PFS final rule that we did not have
enough information to establish national
pricing at this time for HCPCS code
G0465 (87 FR 69420). We stated that we
would consider the commenters’
feedback for future rulemaking while
maintaining contractor pricing for CY
2023, which would allow for more
flexibility for contractors to establish
appropriate pricing using available
information. We appreciated the invoice
submission with additional pricing
information for the SD343 supply and
we updated our supply database for
supply code SD343 at a price of $678.57
based on an average of the submitted
invoices.
Since the publication of the CY 2023
PFS final rule, interested parties have
continued to request national pricing for
HCPCS code G0465 due to their
perception of inconsistent and
insufficient payment for this service by
the MACs. CMS has asked the interested
parties to engage with the MACs to
establish adequate payment for HCPCS
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code G0465. The interested parties have
continued to state that most MACs have
not established consistent payment rates
and the rates are heterogeneous; some
are significantly below the cost of
performing this service, leading to an
unpredictable process and inadequate
rates, creating barriers to access this
service.
Due to these concerns, we are
therefore proposing to establish national
pricing for HCPCS code G0465 for CY
2025. We are proposing to value HCPCS
code G0465 using a crosswalk to CPT
code 15271 (Application of skin
substitute graft to trunk, arms, legs, total
wound surface area up to 100 sq cm;
first 25 sq cm or less wound surface
area), drawing from a selection of
relevant studies.17 18 19 20 We are
proposing a work RVU of 1.50 for
HCPCS code G0465 based on the
crosswalk to CPT code 15271 because
wound surface area sizes in current
literature appear to be less than 100 sq
cm for patients with diabetes and/or
chronic ulcers. We are also proposing to
use the direct PE inputs included with
CPT code 15271 for valuing HCPCS
code G0465, with the additional
inclusion of the 3C patch system
(SD343) supply that we priced in CY
2023. We note that the payment
includes debridement, which may
involve a wound reaching the bone.
Therefore, debridement may not be
billed separately. In addition, we are
currently seeking comments on other
available crosswalks from the broader
medical community. For example, CPT
code 15277 (Application of skin
substitute graft to face, scalp, eyelids,
mouth, neck, ears, orbits, genitalia,
hands, feet, and/or multiple digits, total
wound surface area greater than or
equal to 100 sq cm; first 100 sq cm
wound surface area, or 1% of body area
of infants and children) with a work
RVU of 4.00 and CPT code 15273
(Application of skin substitute graft to
17 Gethin, G et al. ‘‘The profile of patients with
venous leg ulcers: A systematic review and global
perspective.’’ Journal of tissue viability vol. 30,1
(2021): 78–88. doi:10.1016/j.jtv.2020.08.003.
18 Sheehan, Peter et al. ‘‘Percent change in wound
area of diabetic foot ulcers over a 4-week period is
a robust predictor of complete healing in a 12-week
prospective trial.’’ Plastic and reconstructive
surgery vol. 117,7 Suppl (2006): 239S–244S.
doi:10.1097/01.prs.0000222891.74489.33.
19 Oyibo, S O et al. ‘‘The effects of ulcer size and
site, patient’s age, sex and type and duration of
diabetes on the outcome of diabetic foot ulcers.’’
Diabetic medicine: a journal of the British Diabetic
Association vol. 18,2 (2001): 133–8. doi:10.1046/
j.1464–5491.2001.00422.x.
20 Patry, Jérôme et al. ‘‘Outcomes and prognosis
of diabetic foot ulcers treated by an
interdisciplinary team in Canada.’’ International
wound journal vol. 18,2 (2021): 134–146.
doi:10.1111/iwj.13505.
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cases, they are not valued at all, with fee
schedule amounts in most CMS
jurisdictions at or near zero dollars. The
nominator further emphasized that three
physician experts, all employed in
major university medical centers, have
highlighted the challenges posed by the
combination of high supply costs and
inadequate fee schedule payments,
which have hindered their ability to
provide services covered by these codes
over several years. According to the
nominator, these selected physicians
(32) Temporary Female Intraurethral
also expressed frustration with the
Valve-Pump (CPT Codes 0596T and
reluctance of MACs to address or
0597T)
discuss this issue. Moreover, the
In the CY 2024 PFS proposed rule, an nominator highlighted high access
interested party nominated two
barriers as a significant concern. These
Category III CPT codes, CPT codes
barriers primarily affect Medicare’s most
0596T (Initial insertion of temporary
vulnerable beneficiaries, particularly
valve-pump in female urethra) and
women experiencing permanent urinary
0597T (Replacement of temporary valve- retention (PUR), although we note that
pump in female urethra), as potentially
no quantifiable evidence was provided
misvalued. The nominator expressed
to support these statements. We
concern about variability in MAC
acknowledge and appreciate the
pricing for the contractor-priced service. nominator’s efforts in reaching out to
Additionally, the nominator highlighted experts in the field and patients who
that the payment amounts determined
rely on these services to elucidate their
by MACs were inadequately low and
significant needs.
did not account for the time and effort
Since these two Category III CPT
required to furnish the services. In their codes were not identified as potentially
submission, the nominator discussed
misvalued and were consequently
their anticipated inputs for both codes.
priced by contractors, each MAC can set
For CPT code 0596T, the nominator
pricing for the code within its
stated that a physician typically spends
jurisdiction. This could result in
60 minutes inserting the Vesiflo inFlow inevitable variability in MAC pricings
System. The nominator stated that CPT
until they receive a higher number of
code 0596T included various supplies,
claims, as stated by the nominator.
equipment, and clinical labor time
Through our engagement with MACs,
totaling $1,902.76, with the inflow
we found that claims for the two
supply items making up about 99
Category III CPT codes are reviewed on
percent of the total cost of supplies. For a case-by-case basis for medical
CPT code 0597T, the nominator stated
necessity. If the claim is payable, the
that a physician spends 25 minutes
price will be determined at that time by
replacing the Vesiflo inFlow System and the MAC. Additionally, these codes
PE items were similar, with supplies,
were a topic of discussion within the
equipment and clinical labor time
MAC pricing workgroup, and we
costing $505.30, with the inflow supply observed that there was not a significant
items making up about 98 percent of the difference among the MACs in terms of
total cost of supplies. We direct
allowances based on the proposed
interested parties to the CY 2024 PFS
pricing methodologies. However, there
final rule (88 FR 78850) for more
is variance in how MACs load pricing
detailed submission information
for Category III codes. For instance,
regarding CPT codes 0596T and 0597T.
some MACs publish the price for the
After reviewing, we concluded that
service before they receive any claims,
these codes were not potentially
while others set the price only after they
misvalued because they are Category III
receive claims that help determine the
codes describing relatively new and
appropriate pricing. If a MAC does not
low-volume services. Category III codes
load a price for a code before receiving
are contractor priced under the PFS,
any claims, the service can still be paid,
meaning that each MAC can establish
but the allowance has not been
pricing for the code within its
published.
We continue to hear concerns about
jurisdiction, resulting in variability in
these payment inconsistencies for CPT
payments.
This year, the nominator newly
codes 0596T and 0597T. As a result, we
informed CMS that their analysis of
are recommending that the MACs
establish more consistency in pricing,
national payment rates showed that in
enabling the appropriate inclusion of
most CMS jurisdictions, not only are
the Vesiflo system in the code’s PE
these codes misvalued, but in most
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trunk, arms, legs, total wound surface
area greater than or equal to 100 sq cm;
first 100 sq cm wound surface area, or
1% of body area of infants and children)
with a work RVU of 3.50 could also be
viable crosswalk options. We are
soliciting comments regarding our
selection of CPT code 15271 as a
crosswalk code, as well as general
comments and available studies
regarding the appropriate valuation of
HCPCS code G0465.
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valuation. Therefore, for CY 2025, we
encourage interested parties to provide
more accurate and appropriate cost data,
along with additional information
regarding work RVU, work time,
indicators, and utilization estimates for
the MACs. This should complement the
information provided by the nominator
in the CY 2024 final rule (88 FR 78850)
and will facilitate the process. To aid in
this process, we are adding three new
supplies to our direct PE database based
on invoices submitted by interested
parties: the inFlow Measuring Device at
a price of $140 (SD370), the inFlow
Valve-Pump Device at a price of $495
(SD371), and the inFlow Activator Kit at
a price of $1,250 (SD372). Although we
are not proposing national pricing for
these two Category III codes, we do note
for the benefit of the MACs that CPT
code 0596T would typically include one
of each of these supplies, whereas CPT
code 0597T would typically include
only one of the supplies (SD371).
We encourage the MACs to continue
to engage with interested parties by
providing information on how they
price these services. We welcome
additional comments from the broader
medical community regarding the usage
of this service, particularly concerning
its safety and effectiveness, as well as
potential factors contributing to its low
utilization.
(33) PE-Only Replacement Code for
Heart Failure System
Interested parties have expressed
concern about the lack of coding and a
billing mechanism when practitioners
incur costs replacing identified
components of the CardioMEMSTM
Heart Failure System used in the
physician service described by CPT
code 33289 (Transcatheter implantation
of wireless pulmonary artery pressure
sensor for long-term hemodynamic
monitoring, including deployment and
calibration of the sensor, right heart
catheterization, selective pulmonary
catheterization, radiological supervision
and interpretation, and pulmonary
artery angiography, when performed).
The CardioMEMSTM Heart Failure
System furnished during this service
allows practitioners treating heart
failure patients to wirelessly monitor
and measure pulmonary artery pressure
and heart rate in patients with heart
failure and transmit the information to
the physician to inform the treatment
plan for the patient. The system
includes two critical components: first,
a miniaturized, wireless monitor, which
is implanted into a patient’s pulmonary
artery, and second, a smart pillow (the
CardioMEMSTM Patient Electronics
System), which captures and transmits
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readings via safe radio frequency from
the patient’s implanted CardioMEMSTM
Heart Failure System. Overall, the
CardioMEMSTM Heart Failure System
enables patients to transmit critical
heart failure status information to
clinicians regularly, potentially
eliminating the need for frequent clinic
or hospital visits.
Interested parties have highlighted the
critical importance of the device for
heart failure patients who require close
monitoring of weight and blood
pressure to prevent fluid buildup
around the heart, and have requested
that CMS establish coding to describe
when practitioners incur costs during
clinical scenarios when crucial
components of the system require
replacement. Given that these
components are crucial for system
functionality and there is no existing
coding framework to address their
replacement, we believe that
establishing appropriate coding and
payment mechanisms can facilitate the
provision of these services more
effectively in the office and hospital
settings. Given provided information,
we propose assigning contractor pricing
to this PE-only code for CY 2025. We are
proposing a new code, HCPCS code
GMEM1 (Provision of replacement
patient electronics system (for example,
system pillow) for home pulmonary
artery pressure monitoring including
provision of materials for use in the
home and reporting of test results to
physician or qualified health care
professional). We are seeking feedback
from interested parties on our contractor
pricing approach with the aim of
establishing national pricing through
future rulemaking that can be billed
under the OPPS and PFS specifying an
ongoing care visit for the
CardioMEMSTM Heart Failure System
along with the provision of the
replacement part. We are specifically
looking for information from the broader
medical community regarding direct
costs from invoices for the replacement
component referenced above, utilization
estimates, and potential indicators.
Additionally, we solicit comments on
additional direct PE inputs that we
should consider.
(34) Portable X-Ray (HCPCS Codes
R0070–R0075)
Several Portable X-Ray (PXR)
suppliers and trade organizations
continue to express longstanding
concerns with how payment is
established for transportation related to
these services (HCPCS codes R0070–
R0075). CMS has worked with
interested parties over the past several
years to understand the costs of these
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services while taking into consideration
the MACs perspective on pricing of
these costs. Through recent ongoing
discussions with interested parties, we
learned that interested parties are
concerned with the recognition of costs
incurred from PXR services and are
wanting more consistency in the pricing
of these services, including the
application of an inflation factor.
We acknowledge the interested
parties’ concerns and clarify that
interested parties may best engage with
the MACs through appropriate reporting
of cost data in the MAC requested
format. This information provided by
interested parties can help MACs
establish payment rates that are more
reflective of costs incurred. MACs are
then able to consider this cost
information and apply an inflation
factor to update changes in costs year
over year.
However, CMS recognizes that we
should maintain consistency in pricing
these services that are more indicative
of changes in costs that occur yearly.
While still preserving MAC discretion,
CMS highlights the usage of an
ambulance inflation factor (AIF) that is
typically used to adjust ambulance
services, which include transportation
costs. The AIF is updated annually, and
we believe MACs may consider using
the AIF to price PXR services when
establishing payment rates that are more
consistent and reflective of costs
incurred.
Additionally, interested parties
highlighted inconsistency with language
found in our manual and program
memoranda policies related to
transportation costs. Therefore, to
remain consistent and transparent in the
pricing of PXR services, we are
proposing to revise language in our
Medicare Claims Processing manual
(Chapter 13, 90.3 and Chapter 23, 30.5)
to reflect any updates to our guidance
for these services.
(35) Non-Chemotherapy Administration
CMS received inquiries from several
external parties with concerns that
MACs have developed local coverage
determinations (LCDs) and local
coverage articles (LCAs) that down code
or restrict payment for complex and
non-chemotherapeutic drug
administration for CPT code series
96401–96549, when used for the
administration of several biologic and
infusion drugs, including drugs
furnished to treat, for example,
rheumatology related conditions.
CMS requested information in the CY
2024 PFS proposed rule (88 FR 52837)
seeking public feedback regarding the
concerns of down coding or denials for
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the administration of nonchemotherapeutic infusion drugs. We
received comments that asked for
additional clarification from CMS
regarding the payment guidelines for the
complex non-chemotherapeutic
administration code series and updates
to the IOM. Commenters urged CMS to
provide additional guidance clarifying
the conditions under which these
complex infusion drugs should be
payable.
In response to the comments received,
and in response to continuing inquiries
on downcoding and or restrictions on
payment for non-chemotherapy
complex infusion services, we are
proposing an updated policy based
largely on the IOM Medicare Claims
Processing Manual, Chapter 12, section
30.5, to include language currently
consistent with CPT code definitions for
the complex non-chemotherapy
infusion code series stating that the
administration of infusion for particular
kinds of drugs and biologics can be
considered complex and may be
appropriately reported using the
chemotherapy administration CPT
codes 96401–96549. We note that CPT
guidance describes requirements for
these non-chemotherapy complex drugs
or biologic agents to include the need
for staff with advanced practice training
and competency, such as, a physician or
other qualified health care professional
to monitor the patient during these
infusions due to the incidence of severe
adverse reactions. There are also special
considerations for preparation, dosage,
or disposal for these infusion drugs.
These services do involve serious
patient risk which requires frequent
consults with a physician or other
qualified healthcare professional. Based
on these facts and comments, we are
proposing to update our subregulatory
guidance accordingly.
This will also provide complex
clinical characteristics for the MACs to
consider as criteria when determining
payment of claims for these services.
The current IOM language does not
include the unique characteristics of the
administration of these drugs that could
provide additional context to the MACs
when they are determining appropriate
payment. Updating the IOM with the
increased detail of these codes would be
responsive to the concerns and requests
of external parties and will ensure the
IOM is consistent with published
guidance.
Therefore, we are soliciting and
welcome comments on our proposal to
revise the IOM to better reflect how
complex non-chemotherapeutic drug
administration infusion services are
furnished and billed.
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(36) Hospital Inpatient or Observation
(I/O) Evaluation and Management (E/M)
Add-On for Infectious Diseases (HCPCS
Code GIDXX)
Interested parties have continued to
engage with CMS and provide
recommendations to recognize the
increased work associated with
diagnosis, management, and treatment
of infectious diseases that may not be
adequately accounted for in current
hospital inpatient or observation E/M
codes. Infectious diseases are unique in
that they present infection control risks
for the patient and close contacts,
including healthcare staff, that require
attention to safely care for the patient.
They present unique challenges in
diagnosis in that any previous
healthcare interaction could affect the
individual resistance patterns of
pathogens infecting the individual
patient and require close contact with
public health agencies since resistance
patterns are constantly changing, so a
much more extensive medical review is
required. Additionally, individual
decisions regarding treatment are
unique in that use in one patient affects
resistance patterns of the entire
population, which requires additional
expertise to inform antimicrobial
selection and management.
We believe that the timing is
appropriate for establishing a payment
rate for infectious disease physician
services since the COVID–19 PHE has
ignited a hypervigilance for infectious
diseases. Therefore, for CY 2025, we are
proposing a new HCPCS code to
describe intensity and complexity
inherent to hospital inpatient or
observation care associated with a
confirmed or suspected infectious
disease performed by a physician with
specialized training in infectious
diseases. The full proposed descriptor
for the hospital I/O E/M visit
complexity add-on code is HCPCS code
GIDXX (Visit complexity inherent to
hospital inpatient or observation care
associated with a confirmed or
suspected infectious disease by an
infectious diseases consultant,
including disease transmission risk
assessment and mitigation, public
health investigation, analysis, and
testing, and complex antimicrobial
therapy counseling and treatment. (addon code, list separately in addition to
hospital inpatient or observation
evaluation and management visit,
initial, same day discharge, or
subsequent). We anticipate that HCPCS
code GIDXX would be reported by
physicians with specialized infectious
disease training.
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We do not believe we should limit the
scope of codes with which this
proposed add-on HCPCS code could be
billed based on visit level; or initial,
same day discharge, or subsequent
hospital inpatient or observation codes.
We are proposing HCPCS code GIDXX
as an add-on code (ZZZ global period)
separately reportable in addition to CPT
codes 99221 (Initial hospital inpatient
or observation care, per day, for the
evaluation and management of a
patient, which requires a medically
appropriate history and/or examination
and straightforward or low level medical
decision making. When using total time
on the date of the encounter for code
selection, 40 minutes must be met or
exceeded.), 99222 (Initial hospital
inpatient or observation care, per day,
for the evaluation and management of
a patient, which requires a medically
appropriate history and/or examination
and moderate level of medical decision
making. When using total time on the
date of the encounter for code selection,
55 minutes must be met or exceeded.),
99223 (Initial hospital inpatient or
observation care, per day, for the
evaluation and management of a
patient, which requires a medically
appropriate history and/or examination
and high level of medical decision
making. When using total time on the
date of the encounter for code selection,
75 minutes must be met or exceeded.),
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.), 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.), 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
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medically appropriate history and/or
examination and straightforward or low
level of medical decision making. When
using total time on the date of the
encounter for code selection, 45 minutes
must be met or exceeded.), 99235
(Hospital inpatient or observation care,
for the evaluation and management of
a patient including admission and
discharge on the same date, which
requires a medically appropriate history
and/or examination and moderate level
of medical decision making. When using
total time on the date of the encounter
for code selection, 70 minutes must be
met or exceeded.), and 99236 (Hospital
inpatient or observation care, for the
evaluation and management of a patient
including admission and discharge on
the same date, which requires a
medically appropriate history and/or
examination and high level of medical
decision making. When using total time
on the date of the encounter for code
selection, 85 minutes must be met or
exceeded.). Based on feedback from
commenters on the CY 2022 PFS
proposed rule comment solicitation
regarding infectious diseases (86 FR
65125 through 65126) and feedback
from interested parties, HCPCS code
GIDXX would include the following
proposed service elements:
1. Disease Transmission Risk
Assessment and Mitigation
• Developing, following, and
supervising specialized, individualized
infection control protocols for an
individual patient based on their
diagnosis and risks in order to reduce
risk of disease transmission.
• Coordinating with human resources
regarding infection prevention and
control measures to enable healthcare
facility staff to safely care for patient.
• Counseling patients, family
members and caregivers regarding
infection prevention.
• Managing infection prevention and
treatment protocols associated with
transitions of care for complex patients.
2. Public Health Investigation, Analysis,
and Testing
• In-depth patient chart review that
entails going back farther in time and
assessing the complete breadth of all
health care interactions, with higherlevel synthesis for complex diagnoses.
• Communicating with the clinical
microbiology lab and directly reviewing
specimens.
• Coordinating specialized diagnostic
evaluations (for example, identifying
and facilitating diagnostic laboratory
tests only available at specialized
laboratories, the state health
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department, and/or the Centers for
Disease Control & Prevention).
• Coordinating with Federal, State
and local public health agencies and
laboratories to assist with contact
tracing, obtaining specimens for
specialized testing, and/or identifying
prior testing and treatment for
communicable diseases in other
jurisdictions.
3. Complex Antimicrobial Therapy
Counseling & Treatment
• Counseling patients, family
members, and caregivers regarding
antimicrobial stewardship and
resistance for the patient.
• Engaging in complex medical
decision-making associated with
antimicrobial prescribing including
considerations such as antimicrobial
resistance patterns, emergence of new
variants/strains, recent antibiotic
exposure, interactions/complications
from comorbidities including
concurrent infections, public health
considerations to minimize
development of antimicrobial
resistance, and emerging and reemerging infections.
For HCPCS code GIDXX, we are
proposing a work RVU of 0.89 based on
the work RVU for 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. (addon code, list separately in addition to
office/outpatient evaluation and
management visit, new or established)),
which is 0.33, multiplied by a ratio of
the work RVUs for CPT codes 99223 and
99213 (Office or other outpatient visit
for the evaluation and management of
an established patient, which requires a
medically appropriate history and/or
examination and low level of medical
decision making. When using total time
on the date of the encounter for code
selection, 20 minutes must be met or
exceeded.), 3.50 and 1.30, respectively.
(This ratio is the work RVU of CPT code
99223 divided by the work RVU of CPT
code 99213, 3.50 divided by 1.30, which
equals 2.69. Multiplying the 0.33 work
RVU of HCPCS code G2211 times 2.69
results in our proposed work RVU of
0.89.) We believe the relationship
between the complexity add-on HCPCS
code G2211 and a common base code
for the add-on code, CPT code 99213,
would strike the correct balance to
estimate the time and complexity
associated with the new HCPCS code
GIDXX, compared to what we believe
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will be a common base code for this
new add-on code, CPT code 99223.
HCPCS code G2211 has a total time of
11 minutes, therefore, we are proposing
a total time of 30 minutes for HCPCS
code GIDXX based on the same ratio (11
minutes times the same 2.69 ratio equals
30 minutes). HCPCS code G2211 has no
direct PE inputs, and we are proposing
the same for HCPCS code GIDXX.
We believe that the proposed work
RVU appropriately falls between the
following bracket add-on codes: HCPCS
code G0316 (Prolonged hospital
inpatient or observation care evaluation
and management service(s) beyond the
total time for the primary service (when
the primary service has been selected
using time on the date of the primary
service); each additional 15 minutes by
the physician or qualified healthcare
professional, with or without direct
patient contact (list separately in
addition to CPT codes 99223, 99233,
and 99236 for hospital inpatient or
observation care evaluation and
management services). (do not report
g0316 on the same date of service as
other prolonged services for evaluation
and management 99358, 99359, 99418,
99415, 99416). (do not report g0316 for
any time unit less than 15 minutes))
with a work RVU of 0.61 and the
professional principal care management,
chronic care management, and complex
chronic care management CPT codes
99425 (Principal care management
services, for a single high-risk disease,
with the following required elements:
one complex chronic condition
expected to last at least 3 months, and
that places the patient at significant risk
of hospitalization, acute exacerbation/
decompensation, functional decline, or
death, the condition requires
development, monitoring, or revision of
disease-specific care plan, the condition
requires frequent adjustments in the
medication regimen and/or the
management of the condition is
unusually complex due to
comorbidities, ongoing communication
and care coordination between relevant
practitioners furnishing care; each
additional 30 minutes provided
personally by a physician or other
qualified health care professional, per
calendar month (List separately in
addition to code for primary
procedure)), 99437 (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,
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comprehensive care plan established,
implemented, revised, or monitored;
each additional 30 minutes by a
physician or other qualified health care
professional, per calendar month (List
separately in addition to code for
primary procedure)), and 99489
(Complex chronic care management
services with the following required
elements: multiple (two or more)
chronic conditions expected to last at
least 12 months, or until the death of
the patient, chronic conditions that
place the patient at significant risk of
death, acute exacerbation/
decompensation, or functional decline,
comprehensive care plan established,
implemented, revised, or monitored,
moderate or high complexity medical
decision making; each additional 30
minutes of clinical staff time directed by
a physician or other qualified health
care professional, per calendar month
(List separately in addition to code for
primary procedure)) with work RVUs of
1.00.
To help inform whether our proposed
descriptor is appropriate and reflects the
typical service, we are seeking comment
on the typical amount of time infectious
disease physicians spend on the
proposed service elements and the
relative intensity compared to similar
service elements of other CPT codes. We
note that the valuation of HCPCS code
GIDXX is meant to capture the visit
complexity inherent to hospital
inpatient or observation care associated
with a confirmed or suspected
infectious disease by an infectious
diseases consultant that is not
accounted for in the appropriate
hospital inpatient or observation E/M
base code billed by the infectious
disease physician.
Interested parties have stated that
consultations are a common E/M service
performed by infectious disease
clinicians, particularly in the inpatient
setting, but stated that these services are
no longer recognized by Medicare.
Interested parties have also stated that
this has resulted in a significant
reduction in reporting and payment for
infectious disease physician services.
We note that we address this in the CMS
Claims Processing Manual, Chapter 12,
section 30.6.9 F, stating that ‘‘Physicians
may bill initial hospital care service
codes (99221–99223), for services that
were reported with CPT consultation
codes (99241–99255) prior to January 1,
2010, when the furnished service and
documentation meet the minimum key
component work and/or medical
necessity requirements. Physicians may
report a subsequent hospital care CPT
code for services that were reported as
CPT consultation codes (99241–99255)
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prior to January 1, 2010, where the
medical record appropriately
demonstrates that the work and medical
necessity requirements are met for
reporting a subsequent hospital care
code (under the level selected), even
though the reported code is for the
provider’s first E/M service to the
inpatient during the hospital stay.’’
Accordingly, we are seeking comment
on any potential barriers for infectious
disease physicians to use the initial and
subsequent day hospital inpatient or
observation codes, CPT codes 99221
through 99223 and 99231 through
99233, for consultations if they meet the
coding requirements for time and/or
medical decision making (MDM). We
note that understanding the barriers to
utilizing these codes is important, as
these codes will serve as the base codes
for HCPCS code GIDXX, and will need
to be billed by the infectious disease
physician prior to billing HCPCS code
GIDXX.
Finally, we recognize that historically,
the CPT Editorial Panel has frequently
created CPT codes describing services
that we originally established using G
codes and adopted them through the
CPT Editorial Panel process. We note
that we would consider using any newly
available CPT coding to describe
services similar to those described here
in future rulemaking.
(37) Preexposure Prophylaxis (PrEP) of
Human Immunodeficiency Virus (HIV)
To facilitate prompt beneficiary
access to PrEP for CY 2024, we
established 3 HCPCS G codes that
describe the service of counseling and
administration of Human
Immunodeficiency Virus (HIV) preexposure prophylaxis drugs.
Specifically, HCPCS codes G0011
(Individual counseling for pre-exposure
prophylaxis (PrEP) by physician or QHP
to prevent human immunodeficiency
virus (HIV), includes: HIV risk
assessment (initial or continued
assessment of risk), HIV risk reduction
and medication adherence, 15–30
minutes) and G0013 (Individual
counseling for pre-exposure prophylaxis
(PrEP) by clinical staff to prevent human
immunodeficiency virus (HIV), includes:
HIV risk assessment (initial or
continued assessment of risk), HIV risk
reduction and medication adherence)
describe the counseling portion of the
service, and G0012 (Injection of preexposure prophylaxis (PrEP) drug for
HIV prevention, under skin or into
muscle) describes the injection of the
medication.
CMS released a Proposed NCD for
Pre-Exposure Prophylaxis (PrEP) for
Human Immunodeficiency Virus (HIV)
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Infection Prevention on July 12, 2023.
This proposed NCD announced CMS’
intent to cover and pay for those drugs
under the 1861(ddd) additional
preventive services authority, and a
final decision on the NCD is
forthcoming. For CY 2025, we are
proposing national rates for these
HCPCS codes that reflect the relative
resource costs associated with the
counseling and drug administration
portions of the service, pending
finalization of the NCD. For HCPCS
code G0011, we are proposing a work
RVU of 0.45 based off work and direct
PE inputs crosswalked from HCPCS
code G0445 (High intensity behavioral
counseling to prevent sexually
transmitted infection; face-to-face,
individual, includes: education, skills
training and guidance on how to change
sexual behavior; performed semiannually, 30 minutes). For HCPCS code
G0012, we are proposing a work RVU of
0.17 based on the work and direct PE
crosswalked from CPT code 96372
(Therapeutic, prophylactic, or
diagnostic injection (specify substance
or drug); subcutaneous or
intramuscular), and for HCPCS code
G0013 we are proposing a work RVU of
0.18 based on the work and direct PE
inputs crosswalked from 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). We appreciate having this
opportunity for interested parties to
provide feedback on the most accurate
way to value these services.
(38) Opfolda
For CY 2024, to facilitate beneficiary
access to treatment of late-onset Pompe
disease with miglustat in combination
with cipaglucosidae alfa-atga, we
created a new HCPCS code, G0138,
describing the service of administration
of cipaglucosidase alfa-atga (Pombiliti),
which includes the intravenous
administration of cipaglucosidase alfaatga, the provider or supplier’s
acquisition cost of miglustat, clinical
supervision, and oral administration of
miglustat. HCPCS code G0138
(Intravenous infusion of cipaglucosidase
alfaatga, including provider/supplier
acquisition and clinical supervision of
oral administration of miglustat in
preparation of receipt of
cipaglucosidase alfa-atga) was added to
the PFS effective April 1, 2024, as a
contractor priced service. More
information regarding the creation of
HCPCS code G0138 can be found at
https://www.cms.gov/files/document/
2023-hcpcs-application-summary-
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quarter-4-2023-drugs-and-biologicalsupdated-1/30/2024.pdf.
For CY 2025, we are proposing
national pricing for this service that
reflects the relative resource costs
associated with the infusion
administration of Cipaglucosidae alfaatga and clinical supervision and
provision of Miglustat oral with
acquisition costs. We are proposing a
work RVU of 0.21 for HCPCS code
G0138 based on a crosswalk from CPT
code 96365 (Intravenous infusion, for
therapy, prophylaxis, or diagnosis
(specify substance or drug); initial, up to
1 hour). This includes a crosswalked
total time of 9 minutes and an
intraservice time of 5 minutes. We are
also proposing to crosswalk the direct
PE inputs from CPT code 96365 for use
in valuing HCPCS code G0138.
However, we are adding 1 minute of
L056A clinical staff time during the
preservice portion of the service period
to capture the RN/OCN observation of
the patient during administration of the
Opfolda pill. In addition, to account for
the cost of the provision of the selfadministered Opfolda as a direct PE
input, we are incorporating the
wholesale acquisition cost (WAC) data
from the most recent available quarter.
We are proposing a price of $32.50 for
the supply input that describes a 65mg
capsule of Opfolda (supply code
SH111). We are seeking feedback from
interested parties on our proposal of
national pricing, as well as our
proposed work RVU and direct PE
inputs for HCPCS code G0138 to ensure
proper payment for this service.
(39) Payment for Caregiver Training
Services
a. Background
In the CY 2017 PFS final rule (81 FR
80330 through 80331), we finalized
payment for new CPT code(s) describing
administration of a patient-focused
health risk assessment instrument as
well as administration of a caregiverfocused health risk assessment
instrument. In the CY 2024 PFS final
rule (88 FR 78914), we finalized the
assignment of a payable status for
caregiver training services (CTS) for
therapy and behavior management/
modification services (without the
patient present) and finalized the RUCrecommended valuations for these
services to better recognize the role that
caregivers play in reasonable and
necessary care for Medicare
beneficiaries. 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
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strategies and specific activities to assist
the patient in carrying out the treatment
plan.
We finalized in the CY 2024 PFS final
rule 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 patientcentered treatment plan. We also
finalized 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.
Additionally, we finalized 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. These
finalized policies apply to current CTS
coding and we are also proposing for
them to apply to the newly proposed
CTS coding that follows. We continue to
receive questions and requests from
interested parties about how we can
refine payment for these services.
b. Caregiver Assessment
In response to interested parties’
requests for assessment of a caregiver’s
knowledge to be included in caregiver
training, we are clarifying that when
reasonable and necessary, assessing the
caregiver’s skills and knowledge for the
purposes of caregiver training services
could be included in the service
described by CPT code 96161
(Administration of caregiver-focused
health risk assessment instrument (e.g.,
depression inventory) for the benefit of
the patient, with scoring and
documentation, per standardized
instrument) to determine if caregiver
training services are needed. We also
note that CPT code 96161 is currently
on the Medicare Telehealth list.
We note that, as specified in the CY
2017 PFS final rule (81 FR 80330), in
particular cases, caregiver-focused
health risk assessments can be necessary
components of services furnished to
Medicare beneficiaries. Examples where
this service may be reasonable and
necessary may include assessment of
maternal depression in the active care of
infants, assessment of parental mental
health as part of evaluating a child’s
functioning, assessment of caretaker
conditions as indicated where atypical
parent/child interactions are observed
during care, and assessment of
caregivers as part of care management
for adults whose physical or cognitive
status renders them incapable of
independent living and dependent on
another adult caregiver. Commenters
cited that some examples of such
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individuals might include intellectually
disabled adults, seriously disabled
military veterans, and adults with
significant musculoskeletal or central
nervous system impairments (81 FR
80331).
We are proposing that because the
caregiver-focused health risk assessment
may be furnished outside the patient’s
presence, the treating practitioner must
obtain the patient’s (or representative’s)
consent for the caregiver to receive the
assessment. We are also proposing that
the definition of ‘‘caregiver’’ specified in
the CY 2024 PFS final rule (88 FR
78917) will be the same for caregiver
training services and the caregiverfocused health risk assessment.
We are seeking comment on these
proposals and clarifications.
c. Proposals and New Coding
(A) Proposed Direct Care Caregiver
Training Services
i. Coding
We are proposing to establish new
coding and payment for caregiver
training for direct care services and
supports. The topics of training could
include, but would not be limited to,
techniques to prevent decubitus ulcer
formation, wound dressing changes, and
infection control. Unlike other caregiver
training codes that are currently paid
under the PFS, the caregiver training
codes for direct care services and
support focus on specific clinical skills
aimed at the caregiver effectuating
hands-on treatment, reducing
complications, and monitoring the
patient. For example, in the direct care
CTS codes, a caregiver could be taught
how to properly change wound
dressings to promote healing and
prevent infection. This skill, among
other direct care services, would not fall
into the categories of CTS codes that
currently exist (behavior management/
modification or strategies and
techniques to facilitate the patient’s
functional performance in the home or
community) but is integral in
effectuating the patient’s treatment plan.
Like other codes describing caregiver
training services, these proposed new
codes would reflect 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. 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 is
established. The CTS themselves need
to be congruent with the treatment plan
and designed to effectuate the desired
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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.
We are proposing three new HCPCS
codes: GCTD1 (Caregiver training in
direct care strategies and techniques to
support care for patients with an
ongoing condition or illness and to
reduce complications (including, but
not limited to, techniques to prevent
decubitus ulcer formation, wound
dressing changes, and infection control)
(without the patient present), face-toface; initial 30 minutes), GCTD2
(Caregiver training in direct care
strategies and techniques to support
care for patients with an ongoing
condition or illness and to reduce
complications (including, but not
limited to, techniques to prevent
decubitus ulcer formation, wound
dressing changes, and infection control)
(without the patient present), face-toface; each additional 15 minutes (List
separately in addition to code for
primary service) (Use GCTD2 in
conjunction with GCTD1)), and GCTD3
(Group caregiver training in direct care
strategies and techniques to support
care for patients with an ongoing
condition or illness and to reduce
complications (including, but not
limited to, techniques to prevent
decubitus ulcer formation, wound
dressing changes, and infection control)
(without the patient present), face-toface with multiple sets of caregivers)).
We continue to believe that CTS may
be reasonable and necessary when they
are integral to a patient’s overall
treatment and furnished after the
treatment plan is established. The
medical or direct care 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. Direct care training for
caregivers of Medicare beneficiaries
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
training activity should be clearly
identified and documented in the
treatment plan. Additionally, this would
not be billable for patients under home
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health plan of care, receiving at-home
therapy, or receiving DME services for
involved medical equipment and
supplies.
We are seeking additional information
from commenters about potential
service overlaps and potential examples
of direct care services to receive
caregiver training to inform our final
policy. We are soliciting public
comment on each of our proposals for
direct care CTS.
ii. Valuation
For GCTM1, we propose a direct
crosswalk to CPT Code 97550 (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), with a
work RVU of 1.00 as we believe this
service reflects the resource costs
associated when the billing practitioner
performs HCPCS code GCTM1. CPT
code 97550 has an intraservice time of
30 minutes, and the physician work is
of similar intensity to our proposed
HCPCS code GCTM1. Therefore, we are
proposing a work time of 30 minutes
intraservice time (40 minutes of total
time) for HCPCS code GCTM1 based on
this same crosswalk to CPT 97550. We
are also proposing to use this crosswalk
to establish the direct PE inputs for
HCPCS code GCTM1.
For GCTM2, we are proposing a direct
crosswalk to CPT Code 97551 (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; each additional 15 minutes
(List separately in addition to code for
primary service)), with a work RVU of
0.54 as we believe this service reflects
the resource costs associated when the
billing practitioner performs HCPCS
code GCTM2. CPT code 97551 has an
intraservice time of 17 minutes, and the
physician work is of similar intensity to
our proposed HCPCS code GCTM2.
Therefore, we are proposing a work time
of 17 minutes for HCPCS code GCTM2
based on this same crosswalk to CPT
97551. We also propose to use this
crosswalk to establish the direct PE
inputs for HCPCS code GCTM2.
For GCTM3, we propose a direct
crosswalk to CPT Code 97552 (Group
caregiver training in strategies and
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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), with a work RVU of 0.23
as we believe this service reflects the
resource costs associated when the
billing practitioner performs HCPCS
code GCTM3. CPT code 97552 has an
intraservice time of 9 minutes, and the
physician work is of similar intensity to
our proposed HCPCS code GCTM1.
Therefore, we are proposing a work time
of 9 minutes intraservice time (14
minutes total time) for HCPCS code
GCTM3 based on this same crosswalk to
CPT 97552. We are also proposing to
use this crosswalk to establish the direct
PE inputs for HCPCS code GCTM3.
We are seeking comment on supplies/
equipment that would be typical for the
newly created direct care strategies and
techniques CTS codes.
We believe these services would
largely involve contact between the
billing practitioner and the caregiver
through in-person interactions, which
could be conducted via
telecommunications, as appropriate.
Therefore, we are proposing to add
these codes to the Medicare Telehealth
Services List to accommodate a scenario
in which the practitioner completes the
caregiver training service via telehealth.
Please see section II.D. for more
information on Medicare Telehealth
Services.
We are seeking comments on these
proposals.
(B) Individual Behavior Management/
Modification Caregiver Training
Services
i. Coding
We are proposing to establish new
coding and payment for caregiver
behavior management and modification
training that could be furnished to the
caregiver(s) of an individual patient.
Current CPT coding (CPT 96202 and
96203) allows for ‘‘multiple-family
group behavior management/
modification training services,’’
meaning that this caregiver training
service can only be furnished in a group
setting with multiple sets of caregivers
of multiple beneficiaries (please
reference 88 FR 78818 for discussion of
CPT 96202 and 96203). We are
proposing two new HCPCS codes:
GCTB1 (Caregiver training in behavior
management/modification for
caregiver(s) of a patient with a mental
or physical health diagnosis,
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administered by physician or other
qualified health care professional
(without the patient present), face-toface; initial 30 minutes) and GCTB2
(Caregiver training in behavior
management/modification for
caregiver(s) of a patient with a mental
or physical health diagnosis,
administered by physician or other
qualified health care professional
(without the patient present), face-toface; each additional 15 minutes (List
separately in addition to code for
primary service) (Use GCTB2 in
conjunction with GCTB1)).
We continue to believe that CTS may
be reasonable and necessary when they
are integral to a patient’s overall
treatment and furnished after the
treatment plan is established. The
behavior management/modification 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. Behavior management/
modification training for caregivers of
Medicare beneficiaries 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 training
activity should be clearly identified and
documented in the treatment plan. All
other policies and procedures
surrounding CPT 96202 and 96203 will
also apply to these services (88 FR
78914–78920).
We are seeking comment on these
proposals.
ii. Valuation
For GCTB1, we propose a direct
crosswalk to CPT Code 97550 (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), with a
work RVU of 1.00 as we believe this
service reflects the resource costs
associated when the billing practitioner
performs HCPCS code GCTB1. CPT code
97550 has an intraservice time of 30
minutes, and the physician work is of
similar intensity to our proposed
HCPCS code GCTB1. Therefore, we are
proposing a work time of 30 minutes
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intraservice time (40 minutes of total
time) for HCPCS code GCTB1 based on
this same crosswalk to CPT 97550. We
also propose to use this crosswalk to
establish the direct PE inputs for HCPCS
code GCTB1. We are seeking comment
on supplies/equipment that would be
typical for the newly created individual
behavior management/modification CTS
codes.
For GCTB2, we propose a direct
crosswalk to CPT Code 97551 (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; each additional 15 minutes
(List separately in addition to code for
primary service)), with a work RVU of
0.54 as we believe this service reflects
the resource costs associated when the
billing practitioner performs HCPCS
code GCTB2. CPT code 97551 has an
intraservice time of 17 minutes, and the
physician work is of similar intensity to
our proposed HCPCS code GCTB2.
Therefore, we are proposing a work time
of 17 minutes for HCPCS code GCTB2
based on this same crosswalk to CPT
97551. We also propose to use this
crosswalk to establish the direct PE
inputs for HCPCS code GCTB2.
We are seeking comment on supplies/
equipment that would be typical for the
newly created individual behavior
management/modification CTS codes.
We believe these services would
largely involve contact between the
billing practitioner and the caregiver
through in-person interactions, which
could be conducted via
telecommunications as appropriate.
Therefore, we are proposing to add
these codes to the Medicare Telehealth
Services List to accommodate a scenario
in which the practitioner completes the
caregiver training service via telehealth.
Please see section II.D. for more
information on Medicare Telehealth
Services.
We are seeking comments on these
proposals.
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(C) Patient Consent
In the CY 2024 PFS final rule (88 FR
78916), we finalized a requirement that
the treating practitioner must obtain the
patient’s (or representative’s) consent
for the caregiver to receive the CTS and
that the identified need for CTS and the
patient’s (or representative’s) consent
for one or more specific caregivers to
receive CTS be documented in the
patient’s medical record.
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We are proposing that consent for
CTS can be provided verbally by the
patient (or representative). This would
align consent requirements with other
services paid under the PFS that may be
furnished without the patient present,
such as certain care management
services. This proposal would apply to
CPT codes 97550, 97551, 97552, 96202,
and 96203, as well as any caregiver
training services HCPCS codes finalized
in this year’s rule, and any subsequently
created caregiver training service codes.
We are seeking comment on this
proposal.
(D) Addition to Telehealth List
Please see section II.D. of this
proposed rule, Payment for Medicare
Telehealth Services, for the discussion
related to proposals to add CTS to the
Medicare Telehealth list.
(40) Request for Information for
Services Addressing Health-Related
Social Needs (Community Health
Integration (G0019, G0022), Principal
Illness Navigation (G0023, G0024),
Principal Illness Navigation—Peer
Support (G0140, G0146), and Social
Determinants of Health Risk Assessment
(G0136))
a. Background
In the CY 2024 PFS final rule (88 FR
78920), we finalized G-codes to reflect
new coding and payment for services
describing Community Health
Integration (CHI), G0019 (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), and G0022
(Community health integration services,
each additional 30 minutes per calendar
month), which may include a
community health worker (CHW),
incident to the professional services and
under the general supervision of the
billing practitioner. We finalized a new
stand-alone G code describing a SDOH
Risk Assessment, G0136
(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 also finalized PIN
services, described by HCPCS code
G0023 (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
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month) and G0024 (Principal Illness
Navigation services, additional 30
minutes per calendar month); G0140
(Principal Illness Navigation—Peer
Support by certified or trained auxiliary
personnel under the direction of a
physician or other practitioner,
including a certified peer specialist; 60
minutes per calendar month) and G0146
(Principal Illness Navigation—Peer
Support, additional 30 minutes per
calendar month), 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
support specialist, are involved in the
patient’s health care navigation as part
of the treatment plan for a serious, highrisk 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.
b. Request for Information on Services
Addressing Health-Related Social Needs
For CY 2025 we are issuing a broad
request for information (RFI) on the
newly implemented Community Health
Integration (CHI) (HPCCS codes G0019,
G0022), Principal Illness Navigation
(PIN) (HCPCS codes G0023, G0024),
Principal Illness Navigation—Peer
Support (PIN–PS) (HCPCS codes G0140,
G0146), and Social Determinants of
Health Risk Assessment (SDOH RA)
(HCPCS code G0136) services to engage
interested parties on additional policy
refinements for CMS to consider in
future rulemaking.
We are interested in better addressing
the social needs of beneficiaries and
requesting information on the codes we
created and finalized beginning in CY
2024 to fully encompass what interested
parties and commenters believe should
be included in the coding and payment
we recently established. We are seeking
comment on any related services that
may not be described by the current
coding that we finalized in the CY 2024
PFS final rule and that are medically
reasonable and necessary ‘‘for the
diagnosis or treatment of illness or
injury’’ under section 1862(a)(1)(A) of
the Act. We believe we can work within
the current coding framework and
explore additional opportunities to
create codes that describe reasonable
and necessary services furnished by
billing practitioners and the auxiliary
personnel under their general
supervision. We are interested in
feedback regarding any barriers to
furnishing the services addressing
health-related social needs, and if the
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service described by the codes we
established are allowing practitioners to
better address unmet social needs that
interfere with the practitioners’ ability
to diagnose and treat the patient. This
could include barriers specific to certain
populations, including rural and tribal
communities, residents of the U.S.
Territories, individuals with disabilities,
individuals with limited English
proficiency, or other populations who
experience specific unmet social needs.
In response to the CY 2024 PFS
proposed rule, we heard from
commenters that CSWs often connect
individuals with community-based
resources to address unmet social needs
that affect the diagnosis and treatment
of medical problems. CSWs can bill
Medicare directly for services they
personally perform for the diagnosis or
treatment of mental illness but are not
authorized by statute to bill for services
that are provided by auxiliary personnel
incident to their professional services.
Since CHI and PIN codes are typically
provided by auxiliary personnel
supervised by the billing practitioner,
CSWs could serve as the auxiliary
personnel. CSWs could not directly bill
Medicare for CHI and PIN services if
they were provided by auxiliary
personnel, as they are not authorized to
supervise, bill, and be paid directly by
Medicare for services that are provided
by auxiliary personnel incident to their
professional services. We believe the
current CHI and PIN coding accurately
captures the services CSWs currently
provide, including the work involved in
connecting beneficiaries with
community-based resources for unmet
social needs that affect the diagnosis or
treatment of medical problems. As we
stated previously in the CY 2024 PFS
final rule (88 FR 78926), ‘‘the codes do
not limit the types of other health care
professionals, such as registered nurses
and social workers, that can perform
CHI services (and PIN services, as we
discuss in the next section) incident to
the billing practitioner’s professional
services, so long as they meet the
requirements to provide all elements of
the service included in the code,
consistent with the definition of
auxiliary personnel at § 410.26(a)(1).’’
We are clarifying that when we refer to
‘‘certified or trained auxiliary
personnel’’ in the following codes:
G0019, G0022, G0023, G0024, G0140,
G0146, this also includes CSWs.
We are requesting information if there
are other types of auxiliary personnel,
other certifications, and/or training
requirements that are not adequately
captured in current coding and payment
for these services. We are also interested
in hearing more about what types of
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auxiliary personnel are typically
furnishing these services, including the
certifications and/or licensure that they
have. We are also interested in whether
there are nuances or considerations that
CMS should understand related to
auxiliary personnel and training,
certifications or licensure barriers or
requirements that are specifically
experienced by practitioners serving
underserved communities. This could
include settings such as community
mental health centers, community
health clinics including FQHCs and
RHCs, tribal health centers, migrant
farmworker clinics, or facilities located
in and serving rural and geographically
isolated communities including the U.S.
Territories.
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. 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. We stated that,
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 and
PIN services. We stated that we
understood that many community-based
organizations (CBOs) provide social
services and do other work that is
beyond the scope of CHI and PIN
services, but we believed they are wellpositioned to develop relationships with
practitioners for providing reasonable
and necessary CHI and PIN services.
We are interested in hearing more
about CBOs and their collaborative
relationships with billing practitioners.
The new codes for CHI and PIN services
recognized CBOs and their role in
providing auxiliary personnel under the
general supervision of the billing
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61669
practitioners. We are seeking comment
regarding the extent to which
practitioners are contracting with CBOs
(including current or planned
contracting arrangements) for auxiliary
personnel purposes, and if there is
anything else CMS should do to clarify
services where auxiliary personnel can
be employed by the CBO, so long as
they are under the general supervision
of the billing practitioner. Given that the
CHI and PIN services may be provided
incident to the billing practitioner’s
professional services, we are also
seeking comment on whether the
incident to billing construct is
appropriate for CBOs to supplement
pre-existing staffing arrangements and
the CBO/provider interface. We are also
seeking comment on CBOs’ roles, the
extent to which practitioners are
contracting with CBOs, incident to
billing, and auxiliary personnel
employed by CBOs under general
supervision of practitioners serving and
located in rural, tribal and
geographically isolated communities,
including the U.S. Territories.
We are also interested in any
comments from interested parties across
provider types and from practitioners in
geographically isolated communities
(for example, rural, tribal, and island
communities) and otherwise
underserved communities about coding
Z codes on claims associated with
billing for CHI, PIN, and SDOH risk
assessment codes. We recognize that
when screening for social needs, such
needs may be identified and are
interested in learning whether
practitioners are also capturing unmet
social needs on claims using Z codes for
social risk factors or in some other way,
and any barriers or opportunities to
increase coding of Z codes when social
risk factors screen positive.
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 and addressing unmet
social needs that affect the diagnosis
and treatment of medical problems.
Given the Agency’s broader policy goals
of increasing access to care, we are
requesting information from interested
parties and commenters on anything
else that we should consider in the
context of these codes and what else we
could consider to be included in this
newly established code set.
We are seeking comments on ways to
identify specific services and to
recognize possible barriers to improved
access to these kinds of high-value,
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potentially underutilized services by
Medicare beneficiaries.
We are seeking public comment to
understand more clearly how often
evidence-based care for persons with
fractures, for example, is not provided
and the reasons for this, and how recent
or new PFS codes, or their revaluation,
might help resolve specific barriers to
its provision. The PFS currently
includes many codes that pay for
various components of care to manage
patients with fractures over a course of
treatment, such as transitional care
management (TCM) and other care
management services, evaluation and
management visits (including the
inherent complexity add-on for office/
outpatient visits), principal illness
navigation services, community health
integration services, and the social
determinants of health risk assessment.
We refer readers to our recent guidance
on these services on the CMS website at
https://www.cms.gov/files/document/
health-related-social-needs-faq.pdf.
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Medicare also pays for bone mass
measurement/density tests
(MLN006559—https://www.cms.gov/
medicare/prevention/prevntiongeninfo/
medicare-preventive-services/mpsquickreferencechart-1.html#BONE_
MASS, and for outpatient osteoporosis
medication under Part D and, in some
cases, Part B (https://
www.medicare.gov/coverage/
osteoporosis-drugs). These services can
be billed on their own, or in
combination, where applicable. We note
that in the CY 2020 PFS final rule (84
FR 62685) and CY 2021 PFS final rule
(85 FR 84547), CMS indicated that TCM
may be billed concurrently with other
care management codes when relevant,
medically necessary, and not
duplicative.
We are proposing new coding in other
sections of this CY 2025 proposed rule
that might be used to bill for managing
fractures under a treatment plan,
including the global post-operative addon code, HCPCS code GPOC1, in section
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II.G.5 of this proposed rule and the
advanced primary care management
codes in section II.G.2 of this proposed
rule. Interested parties have indicated
that orthopedic surgeons, skilled
nursing facilities (SNFs), and other
practitioners and providers may not be
providing comprehensive patient
centered fracture management care for
quality, payment, or administrative
reasons, and that there is inadequate
‘‘hand-off’’ when post-discharge fracture
care is transferred to practitioners in the
community. They indicate a systemic
disconnect on which provider and/or
specialty is responsible for osteoporosis
diagnosis and treatment, and that global
surgical periods focus on acute fracture
recovery rather than addressing
osteoporosis. We are interested in
hearing if the proposed global postop
add-on code could help resolve these
issues.
BILLING CODE P
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3X019
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Hanrest of skin for skin cell suspension auto graft; first 25
s cm or less
Hanrcst of skin for skin cell suspension auto graft; each
additional 25 sq cm or part thereof (List separately in
addition to code for rim
rocedure
Preparation of skin cell suspension autograft, requiring
enzymatic processing, manual mechanical disaggregation
of skin cells, and filtration; first 25 sq cm or less of
hanrested skin
Preparation of skin cell suspension autograft, requiring
enzymatic processing, manual mechanical disaggregation
of skin cells, and filtration; each additional 25 sq cm of
hanrcstcd skin or part thereof (List separately in addition to
code for rirna
rocedure
Application of skin cell suspension auto graft to wound and
donor sites, including application of primary dressing,
trunk arms le s· first 480 s cm or less
Application of skin cell suspension auto graft to wound and
donor sites, including application of primary dressing,
trunk, arms, legs; each additional 480 sq cm or part thereof
ist se aratel • in addition to code for rim
rocedure
Application of skin cell suspension auto graft to wound and
donor sites, including application of primary dressing, face,
scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands,
feet. and/or multi le di its· first 480 s cm or less
Application of skin cell suspension auto graft to wow1d and
donor sites, including application of primary dressing, face,
scalp, eyelids, mouth, neck, cars, orbits, genitalia, hands,
feet, and/or multiple digits; each additional 480 sq cm or
part thereof (List separately in addition to code for primary
rocedure
Tendon transplantation or transfer, flexor or extensor,
forearm and/or wrist, sin le; each tendon
Arthroplasty, intercarpal or carpometacarpaljoints;
inte osition e , tendon
Transfer or transplant of tendon, carpometacarpal area or
dorsum of hand; without free raft, each tendon
Arthroplasty, intercarpal or carpometacarpaljoints;
suspension, including transfer or transplant of tendon, with
inte osition, when erformed
Therapeutic apheresis; for plasma pheresis
Therapeutic apheresis; with extracorporeal
immunoadsorption, selective adsorption or selective
filtration and lasrna reinfusion
Photopheresis, extracorporeal
Chimeric antigen receptor T-cell (CAR-T) therapy;
harvesting of blood-derived T lymphocytes for
development of genetically modified autologous CAR-T
cells, er day
Chimeric antigen receptor T-cell (CAR-T) therapy;
preparation of blood-derived T lymphocytes for
20:32 Jul 30, 2024
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NEW
:mo
c
Yes
NEW
2.00
C
Yes
NEW
2.51
C
Yes
NEW
2.00
C
Yes
NEW
10.97
C
Yes
NEW
2.50
C
Yes
NEW
12.50
C
Yes
NEW
3.00
C
Yes
8.08
9.50
9.00
No
11.14
11.14
10.50
No
6.90
9.50
9.00
No
NEW
13.90
11.85
No
1.81
1.81
1.81
No
1.56
1.56
1.56
No
1.75
1.75
1.75
No
NEW
1.94
1.94
No
NEW
0.79
0.79
No
E:\FR\FM\31JYP2.SGM
31JYP2
EP31JY24.017
TABLE 13: CY 2025 Work RVUs for New, Revised, and Potentially Misvalued Codes
61672
3X020
3X021
4X015
4X016
4X017
4X018
4X019
59200
5X006
5X007
5X008
5XX05
5XX06
64486
lotter on DSK11XQN23PROD with PROPOSALS2
64487
64488
VerDate Sep<11>2014
Chimeric antigen receptor T-cell (CAR-T) therapy; receipt
and re aration of CAR-T cells for administration
Chimeric antigen receptor T-cell (CAR-T) therapy; CAR-T
cell administration, autolo ous
Excision or destruction, open, intra-abdominal (ie,
peritoneal, mesenteric, retroperitoneal), primary or
secondary tumor(s) or cyst(s), sum of the maximum length
of tumo s) or ·st s ; 5 cm or less
Excision or destruction, open, intra-abdominal (ie,
peritoneal, mcsenteric, retroperitoneal), primary or
secondary tumor(s) or cyst(s), sum of the maximum length
oftumo s or ·st s : 5.1 to 10 cm
Excision or destruction, open, intra-abdominal (ie,
peritoneal, mesenteric, retroperitoneal), primary or
secondary tumor(s) or cyst(s), sum of the maximum length
oftumo s or ·st s : 10.1 to 20 cm
Excision or destruction, open, intra-abdominal (ie,
peritoneal, mcsenteric, retroperitoneal), primary or
secondary tumor(s) or cyst(s), sum of the maximum length
oftumo s or ·st s : 20.1 to 30 cm
Excision or destruction, open, intra-abdominal (ie,
peritoneal, mesenteric, retroperitoneal), primary or
secondary tumor(s) or cyst(s), sum of the maximum length
of tumo s) or ·st s ; ater than 30 cm
Insertion of ceIVical dilator (eg, laminaria, prostaglandin)
se arate rocedure
Insertion of transurethral ablation transducer for delivery of
thermal ultrasound for prostate tissue ablation, including
suprapubic tube placement during the same session and
placement of an endorectal cooling device, when
erformed
Ablation of prostate tissue, transurethral, using thermal
ultrasound, including magnetic resonance imaging
•dance for, and monitorin of, tissue ablation;
Ablation of prostate tissue, transurethral, using thermal
ultrasound, including magnetic resonance imaging
guidance for, and monitoring of, tissue ablation; with
insertion of transurethral ultrasound transducer for delivery
of thermal ultrasound, including suprapubic tube placement
and placement of an endorectal cooling device, when
erformed
Cystourethroscopy with insertion of temporary device for
ischemic remodeling (ie, pressure necrosis) of bladder neck
and rostate
Catheterization with removal of temporary device for
ischemic remodeling (ie, pressure necrosis) of bladder neck
and rostate
Transversus abdominis plane (TAP) block (abdominal
plane block, rectus sheath block) unilateral; by injection(s)
includes ima n
"dance, when erformed
Transvcrsus abdominis plane (TAP) block (abdominal
plane block, rectus sheath block) unilateral; by continuous
"dance, when rformed)
infusion(s) (includes ima ·n
Transversus abdominis plane (TAP) block (abdominal
plane block, rectus sheath block) bilateral; by injections
(includes ima ·n
"dance, when erformed)
20:32 Jul 30, 2024
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Frm 00078
Fmt 4701
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NEW
0.80
0.80
No
NEW
3.00
3.00
No
NEW
22.00
22.00
No
NEW
28.65
28.65
No
NEW
34.00
34.00
No
NEW
45.00
40.00
No
NEW
55.00
50.00
No
0.79
1.20
1.20
No
NEW
4.05
4.05
No
NEW
9.80
9.80
No
NEW
11.50
11.50
No
NEW
3.10
3.10
No
NEW
1.48
1.48
No
1.27
1.20
1.20
No
1.48
1.39
1.39
No
1.60
1.40
1.40
No
E:\FR\FM\31JYP2.SGM
31JYP2
EP31JY24.018
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
64489
64590
64595
66680
66682
6X004
6XX00
6XX01
6XX02
6XX07
6XX08
6XX09
6XX10
6XX11
6XX12
76981
1.75
1.75
No
5.10
5.10
5.10
No
3.79
3.79
3.79
No
6.39
10.25
7.97
No
7.33
10.87
8.74
No
NEW
12.80
10.67
No
NEW
18.95
16.60
No
NEW
5.75
5.75
No
NEW
4.25
4.25
No
NEW
1.50
1.50
No
NEW
1.74
1.74
No
NEW
1.67
1.67
No
NEW
1.83
1.83
No
NEW
1.34
1.34
No
NEW
1.67
1.67
No
0.59
0.59
0.59
No
Ultrasound, elastography; first target lesion
0.59
0.59
0.59
No
76983
Ultrasound, elastography; each additional target lesion
0.50
0.47
0.47
No
1.50
1.50
1.50
No
NEW
0.00
0.00
No
7XX00
lotter on DSK11XQN23PROD with PROPOSALS2
Suture of iris, ciliruy body (separate procedure) with
retrieval of suture through small incision (eg, McCannel
suture
hnplantation of iris prosthesis, including suture fixation
and re air or removal of iris, when rfonned
Magnetic resonance image guided high intensity focused
ultrasound (MRgFUS), stereotactic ablation of target,
intracranial, including stereotactic navigation and frame
lacement when erfonned
Ablation of 1 or more thyroid nodule( s), one lobe or the
isthmus, percutaneous, including imaging guidance,
radiofre uencv
Ablation of 1 or more thyroid nodule(s), additional lobe,
percutaneous, including iinaging guidance, radiofrequency
ist
aratel in addition to code for
rocedure
Thoracic fascial plane block, unilateral; by injection(s),
includin ima •
"dance when erfonned
Thoracic fascial plane block, unilateral; by continuous
·dance when rfonned
infusions includin ima •n
Thoracic fascial plane block, bilateral; by injection(s),
ima •
"dance, when erfonned
inclu
Thoracic fascial plane block, bilateral; by continuous
"dance, when rfonned
infusion s , includin ima •n
Lower extremity fascial plane block, unilateral; by
in"ection s , includin iina in uidance, when erfonned
Lower extremity fascia} plane block, unilateral; by
continuous infusion(s), including imaging guidance, when
rformed
Ultrasound, clastography; parcnchyma (cg, organ)
1.80
76982
77012
VerDate Sep<11>2014
Transversus abdominis plane (TAP) block (abdominal
plane block, rectus sheath block) bilateral; by continuous
infusions includes ima •n
•dance, when erfonned
Insertion or replacement of peripheral, sacral, or gastric
neurostimulator pulse generator or receiver, requiring
pocket creation and connection between electrode array
and ulse enerator or receiver
Revision or removal of peripheral, sacral, or gastric
ncurostimulator pulse generator or receiver, with
detachable connection to electrode arrav
Repair of iris, ciliruy body (as for iridodialysis)
Computed tomography guidance for needle placement (eg,
biopsy, aspimtion, injection, localization device),
radiolo ical su ervision and inte retation
MR safety implant and/or foreign body assessment by
trained clinical staff, including identification and
verification of implant components from appropriate
sources (eg, surgical reports, imaging reports, medical
device databases, device vendors, review of prior imaging),
analyzing current MR conditional status of individual
components and systems, and consulting published
professional guidance with written report; initial 15
minutes
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E:\FR\FM\31JYP2.SGM
31JYP2
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61673
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
61674
7:XX:01
7:XX:02
7:XX:03
7:XX:04
7:XX:05
90480
92132
lotter on DSK11XQN23PROD with PROPOSALS2
92133
92134
VerDate Sep<11>2014
MR safety implant and/or foreign body assessment by
trained clinical staff, including identification and
verification of implant components from appropriate
sources (eg, surgical reports, imaging reports, medical
device databases, device vendors, review of prior imaging),
analyzing current MR conditional status of individual
components and systems, and consulting published
professional guidance with written report; each additional
30 minutes (List separately in addition to code for primary
rocedure
MR safety determination by a physician or other qualified
health care professional responsible for the safety of the
MR procedure, including review of implant MR conditions
for indicated MR examination, analysis of risk vs clinical
benefit of performing MR examination, and determination
of MR equipment, accessory equipment, and expertise
re uired to erfonn examination, with written re art
MR safety medical physics examination customization,
planning and performance monitoring by medical physicist
or MR safety expert, with review and analysis by physician
or other qualified health care professional to prioritize and
select views and imaging sequences, to tailor MR
acquisition specific to restrictive requirements or artifacts
associated with MR conditional implants or to mitigate risk
of non-conditional implants or foreign bodies, with written
re art
MR safety implant electronics preparation under
supervision of physician or other qualified health care
professional, including MR-specific programming of pulse
generator and/or transmitter to verify device integrity,
protection of device internal circuitry from MR
electromagnetic fields, and protection of patient from risks
of unintended stimulation or heating while in the MR
room with written re ort
MR safety implant positioning and/or immobilization
under supervision of physician or other qualified health
care professional, including application of physical
protections to secure implanted medical device from MRinduced translational or vibrational forces, magnetically
induced functional changes, and/or prevention of
radiofrequency bums from inadvertent tissue contact while
in the MR room, with written re ort
Immunization administration by intramuscular injection of
severe acute respiratory syndrome coronavims 2 (SARSCoV-2) (coronavims disease [COVID-19]) vaccine, single
dose
Computerized ophthalmic diagnostic imaging (eg, optical
coherence tomography [OCT]), anterior segment, with
inte retation and re ort, unilateral or bilateral
Computerized ophthalmic diagnostic imaging (eg, optical
coherence tomography [OCT]), posterior segment, with
inte relation and re ort, unilateral or bilateral; o tic nerve
Computerized ophthalmic diagnostic imaging (eg, optical
coherence tomography fOCTl), posterior segment, with
inte retation and re ort, unilateral or bilateral; retina
20:32 Jul 30, 2024
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NEW
0.00
0.00
No
NEW
0.60
0.60
No
NEW
0.76
0.76
No
NEW
0.75
0.75
No
NEW
0.60
0.60
No
X
0.25
0.25
No
0.30
0.29
0.29
No
0.40
0.31
0.31
No
0.45
0.32
0.32
No
E:\FR\FM\31JYP2.SGM
31JYP2
EP31JY24.020
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
93886
93888
93892
93893
93X94
93X95
93X96
96380
96381
96547
96548
96920
96921
96922
97018
97022
Application of a modality to 1 or more areas; whirlpool
97014
97016
97032
97033
lotter on DSK11XQN23PROD with PROPOSALS2
1 or more areas; traction,
Application of a modality to
mechanical
Application of a modality to
stimulation unattended
Application of a modalily lo
vaso neumatic devices
Application of a modality to
97012
97034
97035
VerDate Sep<11>2014
Transcranial Doppler study of the intracranial arteries;
co
Transcranial Doppler study of the intracranial arteries;
limited stud ,
Transcranial Doppler sludy of lhe inlracranial arteries;
emboli detection without intravenous microbubble
in'eclion
Transcranial Doppler study of the intracranial arteries;
venous-arterial shunt detection with intrnvenous
microbubblc in·cction
Vasoreactivity study performed with transcranial Doppler
study ofintracranial arteries, complete (List separately in
addition to code for rimarv rocedure
Emboli detection without intravenous microbubble
injection performed with transcranial Doppler study of
intracranial arteries, complete (List separately in addition
to code for rima
rocedure
Venous-arterial shunt detection with intravenous
microbubble injection performed with transcranial Doppler
study of intracranial arteries, complete (List separately in
addition to code for rimarv rocedure
Administration of respiratory syncytial virus, monoclonal
antibody, seasonal dose by intramuscular injection, with
counseling by physician or other qualified health care
rofessional
Administmtion of respiratory syncytial virus, monoclonal
antibod seasonal dose b intramuscular in·cction
Intraoperative hyperthermic intraperitoneal chemotherapy
(HIPEC) procedure, including separate incision(s) and
closure, when performed; first 60 minutes (List separately
in addition to code for rimarv rocedure
Intraoperative hyperthermic intraperitoneal chemotherapy
(HIPEC) procedure, including separate incision(s) and
closure, when erformed; each additional 30 minutes
Excimer laser treatment for psoriasis; total area less than
250 s cm
Excimer laser treatment for psoriasis; 250 sq cm to 500 sq
cm
Excimer laser treatment for psoriasis; over 500 sq cm
1 or more areas; electrical
1 or more areas;
1 or more areas; paraffin bath
Application of a modality to l or more areas; electrical
stimulation manual , each 15 minules
Application of a modality to 1 or more areas;
ionto horesis each 15 minutes
Application of a modality to 1 or more areas; contrast
baths, each 15 minutes
Application of a modality to 1 or more areas; ultrasom1d,
each 15 minutes
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0.91
0.90
0.90
No
0.50
0.73
0.73
No
1.15
1.15
1.15
No
1.15
1.15
1.15
No
NEW
0.81
0.81
No
NEW
0.73
0.73
No
NEW
0.85
0.85
No
0.24
0.24
0.24
No
0.17
0.17
0.17
No
C
6.53
6.53
No
C
3.00
3.00
No
1.15
1.00
0.83
No
1.30
1.07
0.90
No
2.10
1.32
1.15
No
0.25
0.25
0.25
No
0.18
0.18
0.18
No
0.18
0.18
0.18
No
0.06
0.06
0.06
0.17
0.17
0.17
No
No
0.25
0.25
0.25
No
0.26
0.26
0.26
No
0.21
0.21
0.21
No
0.21
0.21
0.21
No
E:\FR\FM\31JYP2.SGM
31JYP2
61675
EP31JY24.021
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
61676
97110
97112
97113
97116
97140
97530
97533
97535
97537
97542
97810
97811
97813
97814
lotter on DSK11XQN23PROD with PROPOSALS2
9X059
9X075
VerDate Sep<11>2014
Therapeutic procedure, 1 or more areas, each 15 minutes;
therapeutic exercises to develop strength and endurance,
ran c of motion and flexibility
Therapeutic procedure, l or more areas, each 15 minutes;
neuromuscular reeducation of movement, balance,
coordination, kinesthetic sense, posture, and/or
ro rioce tion for sitti and/or standin activities
Therapeutic procedure, 1 or more areas, each 15 minutes;
a uatic thera with thera eutic exercises
Therapeutic procedure, 1 or more areas, each 15 minules;
ait traini
includes stair climb·
Manual therapy techniques (eg, mobilization/
manipulation, manual lymphatic drainage, manual
traction l or more re ons each 15 minutes
Therapeutic activities, direct (one-on-one) patient contact
(use of dynamic activities to improve functional
erformance each 15 minutes
Sensory integrative techniques to enhance sensory
processing and promote adaptive responses to
environmental demands, direcl (one-on-one) patienl
contac each 15 minutes
Self-care/home management training (eg, activities of daily
living (ADL) and compensatory training, meal preparation,
safety procedures, and instructions in use of assistive
technology devices/adaptive equipment) direct one-on-one
contact each 15 minutes
Community/work reintegration training (eg, shopping,
transportation, money management, avocational activities
and/or work environment/modification analysis, work task
analysis, use of assistive technology device/adaptive
e ui ment. direct one-on-one contac each 15 minutes
Wheelchair management (eg, assessment, fitting, training),
each 15 minutes
Acupuncture, l or more needles; without electrical
stimulation, initial 15 minutes of personal one-on-one
contact with the atient
Acupuncture, 1 or more needles; without electrical
stimulation, each additional 15 minutes of personal one-onone contact with the patient, with insertion of needle(s)
ist s aratel • in addition to code for rim , rocedure
Acupuncture, 1 or more needles; with electrical
stimulation, initial 15 minutes of personal one-on-one
contact with the atient
Acupuncture, 1 or more needles; with electrical
stimulation, each additional 15 minules of personal one-onone contact with the patient, with insertion of needle(s)
ist se aratel • in addition to code for rim , rocedure
Computerized ophthalmic diagnostic imaging (eg, optical
coherence tomography [OCT]), posterior segment, with
interpretation and report, unilateral or bilateral; retina,
includin OCT an io ra hy
Synchronous audio-video visit for the evaluation and
management of a new patient, which requires a medically
appropriate history and/or examination and straightforward
medical decision makin . When usin total time on the
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0.45
0.45
0.45
No
0.50
0.50
0.50
No
0.48
0.48
0.48
No
0.45
0.45
0.45
No
0.43
0.43
0.43
No
0.44
0.44
0.44
No
0.48
0.48
0.48
No
0.45
0.45
0.45
No
0.48
0.48
0.48
No
0.48
0.48
0.48
No
0.60
0.61
0.61
No
0.50
0.46
0.46
No
0.65
0.74
0.74
No
0.55
0.47
0.47
No
NEW
0.64
0.64
No
NEW
0.93
I
Yes
E:\FR\FM\31JYP2.SGM
31JYP2
EP31JY24.022
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
61677
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
9X076
9X077
9X078
9X079
9X080
9X081
lotter on DSK11XQN23PROD with PROPOSALS2
9X082
9X083
VerDate Sep<11>2014
Synchronous audio-video visit for the evaluation and
management of a new patient, which requires a medically
appropriate history and/or examination and low medical
decision making. When using total time on the date of the
encounter for code selection, 30 minutes must be met or
exceeded.
Synchronous audio-video visit for the evaluation and
management of a new patient, which requires a medically
appropriate history and/or examination and moderate
medical decision making. When using total time on the
date of the encounter for code selection, 45 minutes must
be met or exceeded.
Synchronous audio-video visit for the evaluation and
management of a new patient, which requires a medically
appropriate history and/or examination and high medical
decision making. When using total time on the date of the
encounter for code selection, 60 minutes must be met or
exceeded.
Synchronous audio-video visit for the evaluation and
management of an established patient, which requires a
medically appropriate history and/or examination and
straightforward medical decision making. When using total
time on the date of the encounter for code selection, 10
minutes must be met or exceeded.
Synchronous audio-video visit for the evaluation and
management of an established patient, which requires a
medically appropriate history and/or examination and low
medical decision making. When using total time on the
date of the encounter for code selection, 20 minutes must
be met or exceeded.
Synchronous audio-video visit for the evaluation and
management of an established patient, which requires a
medically appropriate history and/or examination and
moderate medical decision making. When using total time
on the date of the encounter for code selection, 30 minutes
must be met or exceeded
Synchronous audio-video visit for the evaluation and
management of an established patient, which requires a
medically appropriate history and/or examination and high
medical decision making. When using total time on the
date of the encounter for code selection, 40 minutes must
be met or exceeded.
Synchronous audio-only visit for the evaluation and
management of a new patient, which requires a medically
appropriate history and/or examination, straightforward
medical decision making, and more than 10 minutes of
medical discussion. When using total time on the date of
the encounter for code selection, 15 minutes must be met or
exceeded.
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NEW
1.60
I
Yes
NEW
2.60
I
Yes
NEW
3.50
I
Yes
NEW
0.70
I
Yes
NEW
1.30
I
Yes
NEW
1.92
I
Yes
NEW
2.60
I
Yes
NEW
0.90
I
Yes
E:\FR\FM\31JYP2.SGM
31JYP2
EP31JY24.023
date of the encounter for code selection, 15 minutes must
be met or exceeded.
61678
9X084
9X085
9X086
9X087
9X088
9X089
lotter on DSK11XQN23PROD with PROPOSALS2
9X090
9X091
VerDate Sep<11>2014
Synchronous audio-only visit for the evaluation and
management of a new patient, which requires a medically
appropriate history and/or examination, low medical
decision making, and more than 10 minutes of medical
discussion. When using total time on the date of the
encounter for code selection, 30 minutes must be met or
exceeded.
Synchronous audio-only visit for the evaluation and
management of a new patient, which requires a medically
appropriate history and/or examination, moderate medical
decision making, and more than 10 minutes of medical
discussion. When using total time on the date of the
encounter for code selection, 45 minutes must be met or
exceeded.
Synchronous audio-only visit for the evaluation and
management of a new patient, which requires a medically
appropriate history and/or examination, high medical
decision making, and more than 10 minutes of medical
discussion. When using total time on the date of the
encounter for code selection, 60 minutes must be met or
exceeded.
Synchronous audio-only visit for the evaluation and
management of an established patient, which requires a
medically appropriate history and/or examination,
straightforward medical decision making, and more than 10
minutes of medical discussion. When using total time on
the date of the encounter for code selection, 10 minutes
must be exceeded.
Synchronous audio-only visit for the evaluation and
management of an established patient, which requires a
medically appropriate history and/or examination, low
medical decision making, and more than 10 minutes of
medical discussion When using total time on the date of
the encounter for code selection, 20 minutes must be met or
exceeded.
Synchronous audio-only visit for the evaluation and
management of an established patient, which requires a
medically appropriate history and/or examination,
moderate medical decision making, and more than 10
minutes of medical discussion. When using total time on
the date of the encounter for code selection, 30 minutes
must be met or exceeded.
Synchronous audio-only visit for the evaluation and
management of an established patient, which requires a
medically appropriate history and/or examination, high
medical decision making, and more than IO minutes of
medical discussion When using total time on the date of
the encounter for code selection, 40 minutes must be met or
exceeded.
Brief communication technology-based service (eg, virtual
check-in) by a physician or other qualified health care
professional who can report evaluation and management
services, provided to an established patient, not originating
from a related evaluation and management service
provided within the previous 7 days nor leading to an
evaluation and mana ement service or rocedure within the
20:32 Jul 30, 2024
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NEW
1.55
I
Yes
NEW
2.42
I
Yes
NEW
3.20
l
Yes
NEW
0.65
I
Yes
NEW
1.20
I
Yes
NEW
1.75
I
Yes
NEW
2.60
I
Yes
NEW
0.30
0.30
No
E:\FR\FM\31JYP2.SGM
31JYP2
EP31JY24.024
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
61679
9X100
G0138
G0168
G0283
G0442
G0443
G0444
G0445
G0446
G0447
G0465
G0516
G0517
G0518
GMBTl
lotter on DSK11XQN23PROD with PROPOSALS2
GMBT2
GMBT3
VerDate Sep<11>2014
Medical genetics and genetic counseling services, each 30
minutes of total time provided by the genetic counselor on
the date of the encounter
Intravenous infusion of cipaglucosidase alfaatga, including
provider/supplier acquisition and clinical supervision of
oral administration of miglustat in preparation of receipt of
ci a lucosidase alfa-at a
Wound closure utilizing tissue adhesive(s) only
Electrical stimulation (unattended), to one or more areas
for indication(s) other than wound care, as part of a therapy
lan of care
Annual alcohol misuse screening, 5 to 15 minutes
Brief face-to-face behavioral counseling for alcohol
misuse 15 minutes
Annual depression screening, 5 to 15 minutes
High intensity behavioral counseling to prevent sexually
transmitted infection; face-to-face, individual, includes:
education, skills training and guidance on how to change
sexual behavior crformcd scmi-annuall 30 minutes
Annual, face-to-face intensive behavioral therapy for
cardiovascular disease individual. 15 minutes
Face-to-face behavioral coimseling for obesity, 15 minutes
Autologous platelet rich plasma (prp) or other bloodderived product for diabetic chronic wounds/ulcers, using
an fda-cleared device for this indication, (includes as
applicable administration, dressings, phlebotomy,
centrifugation or mixing, and all other preparatory
rocedures. er treatment
Insertion of non-biodegradable dmg delivery implants, 4 or
more services for subdermal rod im lant
Removal of non-biodegradable dmg delivery implants, 4 or
more services for subdennal im lants
Removal with reinsertion, non-biodegradable drng delivery
implants, 4 or more (services for subdennal implants)
Supply of digital mental health treatment device and initial
education and onboarding, per course of treatment that
au ments a behavioral thera
lan
First 20 minutes of monthly treatment management
services directly related to the patient's therapeutic use of
tl1e digital mental health treatment (DMHT) device tl1at
augments a behavioral therapy plan, physician/other
qualified health care professional time reviewing data
generated from the DMHT device from patient
observations and patient specific inputs in a calendar
month and requiring at least one interactive communication
with the atient/care iver durin the calendar month
Each additional 20 minutes of monthly treatment
mana ement services directly related to the atienfs
20:32 Jul 30, 2024
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NEW
0.00
C
0.00
No
0.21
Yes
0.31
0.31
0.31
No
0.18
0.18
0.18
No
0.18
0.18
0.18
No
0.45
0.60
0.60
No
0.18
0.18
0.18
No
0.45
0.45
0.45
No
0.45
0.45
0.45
No
0.45
0.45
0.45
No
1.50
Yes
C
1.82
l.82
l.82
No
2.10
2.10
2.10
No
3.55
3.55
3.55
No
NEW
C
No
NEW
0.62
No
NEW
0.61
No
E:\FR\FM\31JYP2.SGM
31JYP2
EP31JY24.025
next 24 hours or soonest available appointment, 5-10
minutes of medical discussion
61680
GCDRA
GCDRM
GCTBl
GCTB2
GCTDl
GCTD2
GCTD3
GFCil
lotter on DSK11XQN23PROD with PROPOSALS2
GIDXX
VerDate Sep<11>2014
therapeutic use of the digital mental health treatment
(DMHT) device that augments a behavioral therapy plan,
physician/other qualified health care professional time
reviewing data generated from the DMHT device from
patient observations and patient specific inputs in a
calendar month and requiring at least one interactive
communication with the patient/caregiver during the
calendar month
Administration of a standardized, evidence-based
Atherosclerotic Cardiovascular Disease (ASCVD) Risk
Assessment, 5-15 minutes, not more often than every 12
months
Atherosclerotic Cardiovascular Disease (ASCVD) risk
management services; clinical staff time; per calendar
month
Caregiver training in behavior management/modification
for caregiver(s) of patients with a mental or physical health
diagnosis, administered by physician or other qualified
health care professional (without the patient present), faceto-face; initial 30 minutes
Caregiver training in behavior management/modification
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; each additional
15 minutes
Caregiver training in direct care strategies and techniques
to support care for patients with an ongoing condition or
illness and to reduce complications (without the patient
resent , face-to-face; initial 30 minutes
Caregiver training in direct care strategies and techniques
to support care for patients with an ongoing condition or
illness and to reduce complications (without the patient
resent , face-to-face; each additional 15 minutes
Group caregiver training in direct care strategies and
techniques to support care for patients with an ongoing
condition or illness and to reduce complications (without
the patient present), face-to-face with multiple sets of
care ·vers
Post discharge telephonic follow-up contacts performed in
conjunction with a discharge from the emergency
department for behavioral health or other crisis encounter,
4 calls er calendar month
Visit complexity inherent to hospital inpatient or
observation care associated with a confirmed or suspected
infectious disease by an infectious diseases consultant,
including disease transmission risk assessment and
mitigation, public health investigation, analysis, and
testing, and complex antimicrobial therapy counseling and
treatment. (add--0n code, list separately in addition to
hospital inpatient or observation evaluation and
management visit, initial, same day discharge, or
subse uent
20:32 Jul 30, 2024
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NEW
0.18
No
NEW
0.18
No
NEW
1.00
No
NEW
0.54
No
NEW
1.00
No
NEW
0.54
No
NEW
0.23
No
NEW
1.00
No
NEW
0.89
No
E:\FR\FM\31JYP2.SGM
31JYP2
EP31JY24.026
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
GIPCl
GIPC2
GIPC3
GIPC4
GIPC5
lotter on DSK11XQN23PROD with PROPOSALS2
GIPC6
VerDate Sep<11>2014
Interprofessional telephone/Internet/electronic health
record assessment and management service provided by a
practitioner in a specialty whose covered services are
limited by statute to services for the diagnosis and
treatment of mental illness, including a vetbal and written
report to the patient's treating/requesting practitioner; 5-10
minutes of medical consultative discussion and review
Interprofessional telephone/Internet/electronic health
record assessment and management service provided by a
practitioner in a specialty whose covered services are
limited by statute to services for the diagnosis and
treatment of mental illness, including a vetbal and written
report to the patient's treating/requesting practitioner; 1120 minutes of medical consultative discussion and review
Interprofessional telephone/Internet/electronic health
record assessment and management service provided by a
practitioner in a specialty whose covered services are
limited by statute to services for the diagnosis and
treatment of mental illness, including a vetbal and written
report to the patient's treating/requesting practitioner; 2130 minutes of medical consultative discussion and review
Interprofessional telephone/Internet/electronic health
record assessment and management service provided by a
practitioner in a specialty whose covered services are
limited by statute to services for the diagnosis and
treatment of mental illness, including a vetbal and written
report to the patient's treating/requesting practitioner; 31 or
more minutes of medical consultative discussion and
review
Interprofessional telephone/Internet/electronic health
record assessment and management service provided by a
practitioner in a specialty whose covered services are
limited by statute to services for the diagnosis and
treatment of mental illness, including a written report to the
patient's treating/requesting practitioner, 5 minutes or more
of medical consultative time
Interprofessional telephone/Internet/electronic health
record referral service(s) provided by a treating/requesting
practitioner in a specialty whose covered services are
limited by statute to services for the diagnosis and
treatment of mental illness 30 minutes
20:32 Jul 30, 2024
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NEW
0.35
No
NEW
0.70
No
NEW
1.05
No
NEW
1.40
No
NEW
0.70
No
NEW
0.70
No
E:\FR\FM\31JYP2.SGM
31JYP2
EP31JY24.027
61681
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
GPCMl
GPCM2
lotter on DSK11XQN23PROD with PROPOSALS2
GPCM3
VerDate Sep<11>2014
Advanced primary care management services furnished to
patients requiring primary care provided by clinical
staff/physician/other qualified health care professionals
who are responsible for all primary care and serve as the
continuing focal point for all needed health care services,
per calendar month, with the following elements:
• Development, implementation, revision, and maintenance
of a patient-centered electronic care plan;
• Overall comprehensive care management;
o Systematic needs assessment (medical and psychosocial)
o Ensure receipt of preventive services
o Medication reconciliation, management and oversight of
self-management
• Ongoing communication and care coordination between
relevant practitioners furnishing care (e.g., communitybased care);
o Coordinate with any home- and community-based
clinical service providers, and document communication
with them regarding psychosocial needs and functional
deficits
• Timely management of care transitions (e.g., ED visit and
hospital discharges) and referrals;
o Create/exchange continuity of care documcnt(s) timely
(format not prescribed)
o Communication (direct contact, telephone, electronic)
with the patient and/or caregiver within 7 calendar days of
discharge
• Enhanced communications opportunities and digital
access
o Offer asynchronous non-face-to-face methods other than
telephone, such as secure email or patient portal
o Ensure access to virtual visits and consultations and
digital health communication technology-based services,
such as interprofessional consultations with other
practitioners, virtual check-ins, e-visits, and remote
evaluation of images, to maintain ongoing communication
with atient, as a ro riate ..
Advanced primary care management services furnished to
patients with multiple (two or more) chronic conditions
expected to last at least 12 months, or until the death of the
patient, which place the patient al significant risk of death,
acute exacerbation/decompensation, or functional decline,
provided by clinical staff/physician/other qualified health
care professionals who are responsible for all primary care
and serve as the continuing focal point for all needed health
care services, per calendar month, with the elements
included in GPCMl
Advanced primary care management services furnished to
Qualified Medicare Beneficiaries with multiple (two or
more) chronic conditions expected to last at least 12
months, or until the death of the patient, which place the
patient al significant risk of death, acute
exaceibation/decompensation, or functional decline,
provided by clinical staff/physician/other qualified health
care professionals who are responsible for all primary care
and serve as the continuin focal int for all needed health
20:32 Jul 30, 2024
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PO 00000
Frm 00088
Fmt 4701
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NEW
0.17
No
NEW
0.77
No
NEW
1.67
No
E:\FR\FM\31JYP2.SGM
31JYP2
EP31JY24.028
61682
61683
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
GPOCI
lotter on DSK11XQN23PROD with PROPOSALS2
GSPII
VerDate Sep<11>2014
Post-operative follow-up visit complexity inherent to
evaluation and management services addressing surgical
procedure(s), provided by a physician or qualified health
care professional who is not the practitioner who
performed the procedure (or in the same group practice),
and is of a different specialty than the practitioner who
performed the procedure, within the 090-day global period
of the procedure(s), once per 090-day global period, when
there has not been a formal transfer of care and requires the
following required elements, when possible and applicable:
• Reading available surgical note to understand the
relative success of the procedure, the anatomy that was
affected, and potential complications that could have arisen
due to the unique circumstances of the patient's operation.
• Research the procedure to determine expected postoperative course and potential complications (in the case of
doing a post-op for a procedure outside the specialty).
• Evaluate and physically examine the patient to
determine whether the post-operative course is progressing
appropriately.
• Communicate with the practitioner who performed the
procedure if any questions or concerns arise.
(List separately in addition to office/outpatient evaluation
and management visit, new or established)
NEW
0.16
No
Safety planning interventions, including the following
elements: recognizing warning signs of an impending
suicidal crisis; employing internal coping strategies;
utilizing social contacts and social settings as a means of
distraction from suicidal thoughts; utilizing family
members or friends to help resolve the crisis; contacting
mental health professionals or agencies; and restricting
access to lethal means; (List separately in addition to an
E/M visit or s chothera
NEW
1.09
No
20:32 Jul 30, 2024
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PO 00000
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E:\FR\FM\31JYP2.SGM
31JYP2
EP31JY24.029
care services, per calendar month, with the elements
included in GPCMI
lotter on DSK11XQN23PROD with PROPOSALS2
61684
VerDate Sep<11>2014
20:32 Jul 30, 2024
TABLE 14: CY 2025 Direct PE Refinements
PO 00000
I L037D I RN/LPN/MTA
I NF
I
I Thrc ~ascial pin blk
I L037D I RN/LPN/MTA
I NF
I
I
Frm 00090
I Tap block uni! by
111.JeCllOn
Fmt 4701
6.XX.07
UillllJX
Sfmt 4725
E:\FR\FM\31JYP2.SGM
6XXII
31JYP2
77012
7XX00
EP31JY24.030
I Lwr ~tr fscl pin blk
urn nJx
I L037D I RN/LPN/MTA
I NF
I Cl scan for needle
biopsy
I EL007 I room, CT
I NF
I Mr sfty implt&/fb
asmt stf 1
I L047A I MRI Technologist
I NF
26
I
I
Document
procedure
(nonPACS) (e.g.
mandated
reporting, registry
logs, EEG file, etc.
2
L 13: Refined to correct
17
I rounding error in clinical
17
I rounding error in clinical
17
I rounding error in clinical
I -0.27
labor calculation
L 13: Refined lo correct
I -0.27
labor calculation
L 13: Refined lo correct
I -0.27
labor calculation
9
El I: Refined equipment
time to conform with
other codes in the fanril··
l
L3: Refined clinical labor
time to conform with
I -0.76
identical labor activity in
other codes in the fanrily
I -51.17
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
Jkt 262001
64486
Assist physician or
other qualified
healthcare
professional--directlv related to 17.5
physician work
time (67%of
physician intrasen,icetime
Assist physician or
other qualified
healthcare
professional--directlv related to 17.5
physician work
time (67%of
physician intrasen,ice time)
Assist physician or
other qualified
healthcare
professional--directly related to 17.5
physician work
time (67%of
physician intrasen,ice time)
lotter on DSK11XQN23PROD with PROPOSALS2
VerDate Sep<11>2014
Jkt 262001
asmt stfca
I ED050 I
Technologist PACS
workstation
I NF
I
PO 00000
Frm 00091
7XX01
Fmt 4701
7XX01
Sfmt 4725
E:\FR\FM\31JYP2.SGM
7XX02
I Mr sfty mplt&/tb
asmt stf ea
I Mr sfty mplt&/fb
asmt stf ca
I Mr safety deter
phys/qhp
I L047A I MRI Technologist
I NF
I
I L047A I MRI Technologist
I NF
I
I L047A I MRI Technologist
I NF
I
Mr sfty med physics
xmcstmz
ED053
Professional P ACS
Workstation
F
7XX04
Mr safety implant
elec prepj
L047A
MRI Technologist
NF
31JYP2
7XX.03
7XX04
7XX05
I Mr safety implant
clcc prcpj
Mr safety implt
I pos&/immoblj
I L047A
I
MRI Technologist
I L047A I MRI Technologist
I
NF
I NF
Document
procedure
(nonPACS) (e.g.
mandated
reporting, registry
logs, EEG file, etc.
Perform
procedure/service--NOT directly
related to physician
work time
Document
procedure
(nonPACS) (e.g.
mandated
reporting, registry
loe.s. EEG file etc.
145
132
2
1
I
2
I
I
I
27
13
Clean
room/equipment by I 2
clinical staff
Document
procedure
(nonPACS) (e.g.
2
mandated
reporting, registry
lo~ EEG file, etc.
Document
procedure
12
1 nonPACS) (e.g.
I
14
I
I
1
El6: No equipment times
were included; aligned
equipment time with
assist piiysician time
I -0.29
L3: Rcf111Cd clinical labor
time to conform with
identical labor activity in
other codes in the family
I
Gl: See preamble text
I -9.88
L3: Rcf111Cd clinical labor
time to conform with
identical labor activity in
other codes in the family
I
-0.76
-0.76
10
I
Gl: See preamble text
I -o.so
11
I
GI : See preamble text
I -0.76
1
L3: Refined clinical labor
time to conform with
identical labor activity in
other codes in the family
I -0.76
Il
~3: Rcf111Cd clinical labor
I time
to conform with
I
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
20:32 Jul 30, 2024
7XX01
I Mr sfty mplt&/fb
-0. 76
61685
EP31JY24.031
lotter on DSK11XQN23PROD with PROPOSALS2
61686
VerDate Sep<11>2014
Jkt 262001
PO 00000
7XX05
Frm 00092
96920
Fmt 4701
96920
96920
Sfmt 4725
96921
E:\FR\FM\31JYP2.SGM
96921
96921
96922
31JYP2
96922
96922
G0442
EP31JY24.032
I Mr safety implt
pos&/immoblj
I Mr safety implt
pos&/irnmobli
I Excimcr lsr
psriasis<250sqcm
I Excimer lsr
psriasis<250sqcrn
I Excimer lsr
psriasis<250sqcrn
I Excimcr lsr psriasis
250-500
I Excimer lsr psriasis
250-500
I E~ci1;1er lsr psriasis
2:,0-:,00
I Excimcr lsr
psriasis>500sqcm
I Excimer lsr
psriasis>500sqcm
I Excimer lsr
psriasis>500sqcm
I Amrual alcohol
screen 15 min
IL047A I MRI Technologist
NF
identical labor activity in
I other
codes in the family
I
I
I2
Ii
impression material,
I SL082 I dental putty (per bite
NF
1
()
IEQ161 I laser, excimer
NF
0
36
5
3
I
l
0
I
Clean
I room/equipment by
0
38
5
3
I
1
0
I
Clean
I room/equipment by
0
44
5
3
1
0
5
15
block)
I L037D I RN/LPN/MTA
I SD363
I
laser, excimer, pay per
use (under 250 cm2 )
Clean
I NF
I
NF
IEQ161 I laser, excimer
I NF
IL037D I RN/LPN/MTA
I NF
excimer, pay per
I SD364 I laser,(250-500
Cm2 )
I NF
I EQ161
I
laser, excimer
I
NF
I L037D
I
RN/LPN/MT A
I
NF
I SD365
I
I
NF
USC
laser, excimer, pay per
(> 500cm2)
USC
IL037D I RN/LPN/MTA
I NF
I room/equipment b}
clinical staff
clinical staff
clinical staff
I
I G 1: Sec preamble text
I
-0.76
S4: Supply not mentioned I _2 14
in SOR work description
•
El3: Equipment item
replaces another item; see I 21.22
preamble text
L 1: Refined time to
standard for this clinical I -1.08
labor task
S7: Supply item replaced
by another item; see
I -80.00
.Qreamble
El3: Equipment item
replaces another item; see I 22.40
preamble text
L 1: Refmed time to
standard for this clinical I -1.08
labor task
S7: Supply item replaced
by another item; see
I -83.oo
.Qreamble
El3: Equipment item
replaces another item; see I 25.94
preamble text
L 1: Refined time to
standard for this clinical I -1.08
labor task
S7: Supply item replaced
by another item; see
I -100.00
preamble
Perform
I procedure/service--NOT directly
G 1: See preamble tex"1:
I
5.40
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
20:32 Jul 30, 2024
7:XX:05
mandated
reporting, registiy
logs, EEG file, etc.
Clean
room/equipment b}
clinical staff
lotter on DSK11XQN23PROD with PROPOSALS2
VerDate Sep<11>2014
Jkt 262001
PO 00000
Frm 00093
G0445
I Depression screen
annual
High inten beh couns
std 30m
IL037D I RN/LPN/MTA
EF023
table, exam
I NF
I
NF
I5
17
I 15
I Gl: Sec preamble text
20
Gl: Sec preamble text
Fmt 4701
Sfmt 4725
E:\FR\FM\31JYP2.SGM
31JYP2
G0445
High inten beh conns
std 30m
SK057
paper, laser printing
(each sheet)
NF
10
0
G0445
High inten beh couns
std 30m
SK062
patient cdncation booklet
NF
0
0.5
G0446
Intens behave ther
cardio dx
EF023
table, exam
NF
12
15
G0446
Intens behave ther
cardio dx
SK057
paper, laser printing
(each sheet)
NF
10
0
G0446
Intens behave ther
cardio dx
SK062
patient education booklet
NF
0
0.5
G0447
Behavior counsel
obesitv 15111
EF023
table, exam
NF
17
15
G0447
Behavior counsel
obesity 15m
SK057
paper, laser printing
(each sheet)
NF
1()
()
G0447
I Behavior counsel
obesity 15111
I SK062 I patient education booklet I NF
I
lo
I 0.5
S7: Supply item replaced
by another item; see
-reamble
u8: Supply item replaces
anotlJCr item; sec
preamble
Gl: See preamble text
S7: Supply item replaced
by another item; see
-reamble
u8: Supply item replaces
anotlier item; see
orcamble
GI: See preamble text
I
S7: Supply item replaced
by another item; see
-reamble
u8: Supply item replaces
another item; see
--..mble
I o.o3
I -0.20
I 1.40
I o.o3
I -0.20
I 1.40
I -0.02
I -0.20
I 1.40
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
20:32 Jul 30, 2024
G0444
related to physician
work time
Perform
procedure/service--NOT directly
related to physician
work time
61687
EP31JY24.033
lotter on DSK11XQN23PROD with PROPOSALS2
Jkt 262001
PO 00000
64486
I
Tap block
unil by
injection
I
Thrc fascial
pln blkuni
njx
I
Thrc fascial
pln blkuni
njx
I
Lwr xtrfscl
pln blkuni
njx
I
Lwr xtrfscl
pln blkuni
njx
I
Mr safety
implant elec
prepj
I
Mr safety
implant elec
prepj
Frm 00094
I
Fmt 4701
6XX07
Sfmt 4725
6XX07
E:\FR\FM\31JYP2.SGM
6XX11
31JYP2
6XX11
7XX04
7XX04
EP31JY24.034
EF018
stretcher
EQ0ll
ECG, 3channel
(withSpO2,
NlBP, temp,
resp)
EF018
stretcher
EQ0ll
ECG, 3channel
(withSpO2,
NlBP, temp,
resp)
EF018
stretcher
EQ0ll
ECG, 3channel
(withSpO2,
NlBP, temp,
reso)
NF
NF
NF
NF
NF
NF
25.5
25.5
25.5
25.5
25.5
25.5
25
El5: Refined
equipment time to
conform to changes
in clinical labor time
I
-0.01
25
E 15: Refined
equipment time to
conform to changes
in clinical labor time
I
-0.01
25
El5: Refined
equipment time to
conform to changes
in clinical labor time
I
-0.01
25
E 15: Refined
equipment time to
conform to changes
in clinical labor time
I
-0.01
25
El5: Refined
equipment time to
conform to changes
in clinical labor time
I
-0.01
25
E 15: Refined
equipment time to
conform to changes
in clinical labor time
I
-0.01
I
-3.28
I
-0.32
EL008
room, MR
NF
21
20
EQ412
Vitals
monitoring
system(MR
Conditional)
NF
21
20
El5: Refined
equipment time to
conform to changes
in clinical labor time
El5: Refined
equipment time to
conform to changes
in clinical labor time
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
20:32 Jul 30, 2024
64486
Tap block
unil by
injection
61688
VerDate Sep<11>2014
TABLE 15: CY 2025 Direct PE Refinements - Equipment Refinements Conforming to Changes in Clinical Labor Time
lotter on DSK11XQN23PROD with PROPOSALS2
VerDate Sep<11>2014
Jkt 262001
PO 00000
Frm 00095
I
7:XX:05
I
uuyu
96920
I psriasis<250s
n
n
,.
,.
, , I EL008 I room, MR
''
I
NF
I
I
24
I
23
Fmt 4701
Sfmt 4725
E:\FR\FM\31JYP2.SGM
31JYP2
NF
24
23
EF031
table, power
NF
38
36
EQ168
light, exam
NF
38
36
EF031
table, power
NF
40
38
EQ168
light, exam
NF
40
38
EF031
table, power
NF
46
44
EQ168
light, exam
NF
46
44
EF023
table, exam
NF
10
15
EF023
table, exam
NF
10
15
I
Excimerlsr
gem
Excimerlsr
96920
I psriasis<250s
gem
Excimerlsr
96921
I psriasis 250500
Excimerlsr
96921
I psriasis 250500
Excimerlsr
96922
I psriasis>500s
gem
Excimerlsr
96922
I psriasis>500s
gem
Annual
G0442
I alcohol screen
15 min
G0444
EP31JY24.035
I Depression
screen annual
El5: Refined
equipment time to
conform to changes
in clinical labor time
El5: Refined
equipment time to
conform to changes
in clinical labor time
El5: Refined
equipment time to
conform to changes
in clinical labor time
El5: Refined
equipment time to
conform to changes
in clinical labor time
El5: Refined
equipment time to
conform to changes
in clinical labor time
El5: Refined
equipment time to
conform to changes
in clinical labor time
El5: Refined
equipment time to
conform to changes
in clinical labor time
El5: Refined
equipment time to
conform to changes
in clinical labor time
El5: Refined
equipment time to
conform to changes
in clinical labor time
El5: Refined
eQuipment time to
I -3.28
I -0.32
I -0.03
I -0.01
I -0.03
I -0.01
I -0.03
I -0.01
I o.o5
I o.o5
61689
Vitals
monitoring
system (MR
Conditional)
I EQ412
I
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
20:32 Jul 30, 2024
7:XX:05
uuyu
VerDate Sep<11>2014
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
20:32 Jul 30, 2024
Jkt 262001
PO 00000
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Fmt 4701
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E:\FR\FM\31JYP2.SGM
31JYP2
EP31JY24.036
lotter on DSK11XQN23PROD with PROPOSALS2
61690
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
61691
30140,
30901,
30903,30905,
30906,
31231,
31237,
31238,
43197 43198
65778
88341
88341,
88342,
88344,
88360,88361
88341,
88342,
88344,
88360,88361
88341,
88342,
88344,
88360 88361
88341,
88342,
88344,
88360 88361
88341,
88342,
88344,
88360,88361
lotter on DSK11XQN23PROD with PROPOSALS2
88342
92240,92242
VerDate Sep<11>2014
Atomizer tips
(disposable)
human
amniotic
membrane
allogrnft
mounted ona
nonabsorbable
self-retaining
rin
Anti CD45
Monoclonal
Antibod
Benchmark
ULTRA
automated
slide
preparation
s stem
Reaction
buffer l0X
(Ventana 950300
Liquid
coverslip
(Vcntana 650010
SSC (lOX)
(Ventana 950110)
Cell
Conditioning 1
(Ventana 950124)
Confirm antiCD15 Mouse
Monoclonal
Antibody
(Ventana 7602504
indocyanine
green (25ml
uou
20:32 Jul 30, 2024
Jkt 262001
SL464
$0.00
2.66
1
625,876
SD248
$931.33
$1,149.00
23%
30
52,203
SL495
$5.15
$8.73
70%
3
1,094,158
EP112
$125,040.59
$130,000.00
4%
2
2,683,605
SL478
$0.037
$0.045
22%
3
2,683,605
SL479
$0.051
$0.084
65%
3
2,683,605
SL480
$0.051
$0.069
35%
2
2,683,605
SL482
$0.560
$0.937
67%
3
2,683,605
SL474
$4.90
$9.24
89%
3
1,157,793
SL083
$76.94
$125.11
63%
8
36,974
PO 00000
Frm 00097
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Sfmt 4725
E:\FR\FM\31JYP2.SGM
31JYP2
EP31JY24.037
TABLE 16: CY 2025 Invoices Received for Existing Direct PE Inputs
61692
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
306 codes
7 codes
Deleted from
all codes
67221
38 codes
lotter on DSK11XQN23PROD with PROPOSALS2
145 codes
VerDate Sep<11>2014
SD339
$260.35
$292.50
12%
20
510,943
needle,
acupuncture
SC075
$0.10
$0.199
99%
1
263,591
SA042
$19.43
31.29
61%
2
SA045
$17.33
$14.99
-14%
2
SA046
$7.26
SA049
$16.35
$26.35
61%
2
SA058
$113.70
$37.63
-67%
2
SA082
$3.91
$2.33
-40%
1
pack, cleaning
and
disinfecting,
endosco e
pack, drapes,
c stosco
pack, drapes,
laparotomy
(chestabdomen)
pack, ocular
photodynamic
thera
pack, urology
cystoscopy
visit
pack,
ophthalmology
visit (wdilation
20:32 Jul 30, 2024
Jkt 262001
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E:\FR\FM\31JYP2.SGM
31JYP2
1,062
EP31JY24.038
93241,
93243,
93245,93247
97810,
97811,
97813, 97814
extended
external ECG
patch, medical
magnetic tape
recorder
61693
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
TABLE 17: CY 2025 New Invoices
5X006, 5X007,
5X008
TULSA-PRO TDC Cart
5X007, 5X008
TULSA-PRO Dis osable Kit
5XX05
iTIND device
6XX01
RF Electrodes 18 Ga e70mm Len th
RF Ablation System VI 000 and RF
Pum
Disposable oximeter probe and clip (MR
Conditional
Vitals monitoring system (MR
Conditional
Thermoplastic splint material 6"x9" (MR
Safe
Mupirocin 2% Topical Ointment 22
ams
laser, excimer, pay per use (under 250
cm.2
laser, excimer, pay per use (250-500 cm.2
7XX04, 7XX05
7XX04, 7XX05
7XX05
96920, 96921,
96922
96920
96921
laser. excimer, a er use > 500cm.2
tomographic device, optical coherence
an io
96922
9X059
lotter on DSK11XQN23PROD with PROPOSALS2
G0138
No codes
inFlow Measurin Device
No codes
inFlow Valve-Pum Device
No codes
306 codes
(component of
SA042
306 codes
(component of
SA042
7 codes (component
ofSA045
7 codes (component
ofSA045)
22510, 22511,
22513,22514
67221 (component
ofSA049)
67221 (component
ofSA049)
145 codes
(component of
SA082
inFlow Activator Kit
VerDate Sep<11>2014
20:32 Jul 30, 2024
ortho-phthalaldehyde 0.55% (eg, Cidex
OPA
ortho- hthalaldeh de test stri s
dra
drape, surgical, split, impervious,
absorbent
Abdominal Drape Laparotomy Drape
Sterile (100 in x 72 in x 124 in)
kit, ocular hotodvnamic thera
,cpon
SD36
3
SD36
4
SD36
5
EQ40
9
SH11
1
SD37
0
SD37
1
SD37
2
2,300
8,967.00
2
847
2,695.00
2
295
1,995.00
3
10
49,950.0
0
2
11
6.40
1
19,215
85,182.6
0
1
19,215
21.75
1
76
0.139
l
108,634
80.00
5
73,369
83.00
4
21,696
100.00
3
13,569
164,500.
00
2
360,890
32.50
0
3,955
140.00
495.00
1,250.00
1
SM03
0
0.554
1
SM03
1
1.556
1
3.284
1
8.424
1
8.049
1
12,721
26.00
1
1,062
0.352
1
1,062
SB05
7
S805
8
SB05
6
SA13
7
SD36
7
SB05
9
ost-m driatic s ectacles
Jkt 262001
SJ095
1,638.60
0.328
1
PO 00000
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Sfmt 4725
E:\FR\FM\31JYP2.SGM
31JYP2
EP31JY24.200
6XX01, 6XX02
EQ41
0
SA13
6
SD36
6
SD36
8
EQ41
1
SD36
9
EQ41
2
SG10
0
61694
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
VerDate Sep<11>2014
15XX1
Hrv skn ell ssp agrft 1st 25
15XX2
Hrv skn ell ssp agrft ea add
15XX3
Prepj skn ell ssp agrft 1st
15:XX:4
Prepj skn ell ssp agrft ea
15:XX:5
App skn cl ssp agrft t/a/11
15XX6
App skn cl ssp agrft/a/1 ea
15:XX:7
App skn ell ssp f/n/g/hf 1st
15XX8
App skn ell ssp f/n/g/hf ea
25310
Transplant forearm tendon
25447
Repair wrist joints
26480
Transplant hand tendon
2X005
Arthrp ntrcrpl/crp/mtcrp ssp
36514
Apheresis plasma
36516
Apheresis immunoads slctv
36522
Photopheresis
3X018
Car-t hrv bld-drv t lymphcyt
3X019
Car-t prep t lymphcyt f/trns
3X020
Car-t receipt&prepj admn
3X021
Car-t admn autologous
4X015
Opn exc/dstr ntra-abd 5 cm/<
4X016
Opn exc/dstrntra-abd 5.1-10
4X017
Opn exc/dst ntra-abd 10.1-20
4X018
Opn exc/dst ntra-abd 20.1-30
4X019
Opn exc/dstr ntra-abd >30 cm
59200
Insert cervical dilator
5X006
Ins trurl ablt trnsdc thr us
5X007
Ablt trurl prst8 tis thrm us
5X008
Ablt trurl prst8 tis trnsdcr
5:XX05
Cysto insj dev ischmc rmdlg
5XX06
Cathj rmvl dev ischmc rmdlg
64487
Tap block uni by infusion
64488
Tap block bi injection
64489
Tap block bi by infusion
64590
Ins/rpl prph sac/gstr npg/r
64595
Rev/rmv prph sac/gstr npg/r
66680
Repair iris & ciliary body
66682
Repair iris & ciliary body
6X004
Implantation iris prosthesis
6XX00
Mrgfus strtctc ablt trgt icr
6XX01
Abltj 1/-thyr ndul llobe prq
6XX02
Abltj 1/-thyr ndul add! prq
20:32 Jul 30, 2024
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E:\FR\FM\31JYP2.SGM
31JYP2
EP31JY24.201
lotter on DSK11XQN23PROD with PROPOSALS2
TABLE 18: CY 2025 No PE Refinements
VerDate Sep<11>2014
6XX08
Thrc fascial pin blk uni nfs
6:XX09
Thrc fascia! pin blk bi njx
6XXI0
Thrc fascial pin blk bi nfs
6XX12
Lwr xtr fscl pin blk uni nfs
76981
Use parenchyma
76982
Use I st target lesion
76983
Use ea addl target lesion
90480
Admn sarscov2 vacc 1 dose
92132
Cmptr ophth dx img ant segmt
92133
Cmptr ophth img optic nerve
92134
Cptr ophth dx img post segmt
93886
Tntracranial complete study
93888
lntracranial limited study
93892
Ted emboli detect w/o inj
93893
Ted emboli detect w/inj
93X94
Vsrctv std tcd icr art comp!
93X95
Emboli detcj wo iv mbubb njx
93X96
Ven-artl shunt det mbubb njx
96380
Admn rsv monoc antb im ens!
96381
Admn rsv monoc antb im njx
97012
Mechanical traction therapy
97014
Electric stimulation therapy
97016
Vasopneumatic device therapy
97018
Paraffin bath therapy
97022
Whirlpool therapy
97032
Appl modality l +estim ea 15
97033
App mdlty I +iontphrsis ea 15
97034
App mdlty 1+cntrst bth ea 15
97035
App mdlty 1+ultrasound ea 15
97110
Therapeutic exercises
97112
Neuromuscular reeducation
97113
Aquatic therapy/exercises
97116
Gait training therapy
97140
Manual therapy 1/> regions
97530
Therapeutic activities
97533
Sensory integration
97535
Self care mngment training
97537
Community/work reintegration
97542
Wheelchair mngmenl training
97810
Acupunct w/o stimul 15 min
97811
Acupunct w/o stimul addl 15m
97813
Acupunct w/stimul 15 min
97814
Acupunct w/stimul addl I Sm
20:32 Jul 30, 2024
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E:\FR\FM\31JYP2.SGM
31JYP2
61695
EP31JY24.202
lotter on DSK11XQN23PROD with PROPOSALS2
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
9X059
Cptrz oph img pst sg rta oct
9X075
Synch audio-video new sf 15
9X076
Synch audio-video new low 30
9X077
Synch audio-video new mod 45
9X078
Synch audio-video new hi 60
9X079
Synch audio-video est sf l 0
9X080
Synch audio-video est low 20
9X081
Synch audio-video est mod 30
9X082
Synch audio-video est hi 40
9X083
Synch audio-only new sf 15
9X084
Synch audio-only new low 30
9X085
Synch audio-only new mod 45
9X086
Synch audio-only new high 60
9X087
Synch audio-only est sf 10
9X088
Synch audio-only est low 20
9X089
Synch audio-only est mod 30
9X090
Synch audio-only est high 40
9X091
Brief comunicaj tech-bsd svc
9X100
Genetic counseling svc ea 30
00168
Wound closure by adhesive
G0283
Elec stim other than wound
00443
Brief alcohol misuse counsel
G0516
Insert drug del implant, >=4
G0517
Remove drug implant
00518
Remove w insert drug implant
lotter on DSK11XQN23PROD with PROPOSALS2
F. Evaluation and Management (E/M)
Visits
1. Office/Outpatient (O/O) Evaluation
and Management (E/M) Visit
Complexity Add-On
In the CY 2024 PFS final rule (88 FR
78970 through 78982), we finalized
separate payment for the O/O E/M visit
complexity add-on code. The full
descriptor for the O/O E/M visit
complexity add-on code, HCPCS code
VerDate Sep<11>2014
20:32 Jul 30, 2024
Jkt 262001
G2211, is (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)).
PO 00000
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Fmt 4701
Sfmt 4702
The O/O E/M visit complexity add-on
code ‘‘reflects the time, intensity, and
PE resources involved when
practitioners furnish the kinds of O/O E/
M visit services that enable them to
build longitudinal relationships with all
patients (that is, not only those patients
who have a chronic condition or single
high-risk disease) and to address the
majority of a patient’s health care needs
with consistency and continuity over
longer periods of time.’’ (88 FR 78970
E:\FR\FM\31JYP2.SGM
31JYP2
EP31JY24.203
61696
lotter on DSK11XQN23PROD with PROPOSALS2
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
through 78971). We explained in the CY
2024 PFS final rule that it is the
relationship between the patient and the
practitioner that is the determining
factor for when the add-on code should
be billed. The add-on code captures the
inherent complexity of the visit that is
derived from the longitudinal nature of
the practitioner and patient
relationship. The first part of the code
descriptor, the ‘‘continuing focal point
for all needed health care services,’’
describes a relationship between the
patient and the practitioner when the
practitioner is the continuing focal point
for all health care services that the
patient needs. The second part of the
add-on code also describes a
relationship involving medical services
that are part of ongoing care related to
a patient’s single, serious condition or a
complex condition. There is previously
unrecognized but important cognitive
effort of utilizing the longitudinal
relationship in making a diagnosis,
developing a treatment plan, and
weighing the factors that affect a
longitudinal doctor-patient relationship.
The practitioner must decide what
course of action and choice of words in
the visit itself would lead to the best
health outcome in the single visit while
simultaneously building up an effective,
trusting longitudinal relationship with
the patient. Weighing these various
factors, even for a seemingly simple
condition, makes the entire visit
inherently complex, which is what this
add-on code is intended to capture (88
FR 78973 through 78974).
We responded to concerns raised by
commenters about potential duplicative
payment and potential misreporting of
the code, noting that when procedures
or other services are reported on the
same day by the same billing
practitioner as a significant, separately
identifiable O/O E/M visit (the base
codes that the visit complexity add-on
code can be billed with), we believed
that the services involve resources that
are sufficiently distinct from the costs
associated with furnishing stand-alone
O/O E/M visits to warrant a different
payment policy (88 FR 78971). We
finalized our proposal that the O/O E/
M visit complexity add-on code is not
payable when the O/O E/M visit is
reported with CPT Modifier–25, which
denotes a significant, separately
identifiable O/O E/M visit by the same
physician or other qualified health care
professional on the same day as a
procedure or other service (88 FR
78974).
Some commenters expressed concern
about our proposal to exclude payment
for the visit complexity add-on code
when the O/O E/M base code is reported
VerDate Sep<11>2014
20:32 Jul 30, 2024
Jkt 262001
with Modifier–25 because some
preventive services such as the annual
wellness visit (AWV) or a preventive
vaccine are often provided on the same
day as a separately identifiable O/O E/
M visit, appropriately billed with
Modifier–25. The commenters were
concerned that practitioners might
avoid the policy by not providing a
preventive service on the same day as
another O/O E/M service. We
acknowledged that immunizations and
AWVs were sometimes furnished on the
same day as an O/O E/M visit and that
our policy would prevent payment of
the add-on code with such office visits
billed with Modifier–25 and indicated
that we would monitor utilization of the
visit complexity add-on code and
continue engagement with interested
parties as the policy is implemented (88
FR 78975).
We have begun to monitor utilization
of HCPCS code G2211 and are
continuing to engage with interested
parties. We continue to hear from some
practitioners that our non-payment of
the O/O E/M visit complexity add-on
code when the O/O E/M base code is
reported on the same day as a
preventive immunization or other
Medicare preventive service is
disruptive to the way such care is
usually furnished and contrary to our
policy objective for establishing the addon payment. An early analysis of
practitioner claims from the first few
months of 2024 shows relatively few
Medicare preventive services being
billed on the day preceding or following
an O/O E/M visit. We cannot conclude
from this analysis that our policy to
deny payment of the O/O E/M visit
complexity add-on code when the O/O
E/M base code is reported on the same
day as a preventive immunization or
other Medicare preventive service is
disruptive to the way such care is
usually furnished. However, we do
agree with practitioners expressing
concerns that the current policy is not
well-aligned with our policy objective
for establishing the add-on payment.
In response to these concerns, we are
proposing to refine our current policy
for services furnished beginning in CY
2025. We are proposing to allow
payment of the O/O E/M visit
complexity add-on code when the O/O
E/M base code is reported by the same
practitioner on the same day as an
AWV, vaccine administration, or any
Medicare Part B preventive service
furnished in the office or outpatient
setting. Allowing payment for the O/O
E/M visit complexity add-on code in
this scenario as proposed would support
our policy aims, which include paying
for previously unaccounted resources
PO 00000
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61697
inherent in the complexity of all
longitudinal primary care office visits.
In part, the O/O E/M visit complexity
add-on code recognizes the inherent
costs of building trust in the
practitioner-patient relationship. We
believe that trust-building in the
longitudinal relationship is more
significant than ever in making
decisions about the administration of
immunizations and other Medicare Part
B preventive services. We welcome
comments on this proposal.
G. Enhanced Care Management
1. Background
The CMS Center for Medicare and
Medicaid Innovation (CMS Innovation
Center) tests innovative payment and
service delivery models to reduce
program expenditures while preserving
or enhancing quality of care. CMS
Innovation Center models are assessed
for their impact on quality of care and
expenditures under Medicare,
Medicaid, and the Children’s Health
Insurance Program (CHIP) and the scope
and duration of the model test may be
expanded through rulemaking if
expected to either reduce spending
without compromising quality of care or
enhance quality of care without
increasing spending (section 1115A of
the Act). After more than a decade of
testing over 50 innovative payment and
service delivery models, the CMS
Innovation Center has enabled broad
transformative changes to service
delivery and payment in the Medicare,
Medicaid, and CHIP programs which
inspire additional transformation
throughout the health care delivery
system. Participants in CMS Innovation
Center models have demonstrated
improvements in care delivery and
patient experience. The CMS Innovation
Center undertook a retrospective review
and synthesis of select model
evaluations where care delivery changes
have been observed, and the review
indicated demonstrable evidence of
enhanced care delivery in several areas,
such as care coordination, team-based
care, and leveraging data to risk-stratify
patients.21
Under the Medicare Physician Fee
Schedule (PFS) statute at section 1848
of the Act, we establish payment
21 Fowler, Ph.D., JD, E., Rudolph, MPH, N.,
Davidson, LCSW, MSW, K., Finke, MD, B., Flood,
S., Bernheim, MD, Ph.D., S. M., & Rawal, Ph.D., P.
(2023). Accelerating Care Delivery
Transformation—The CMS Innovation Center’s Role
in the Next Decade. New England Journal of
Medicine, 4(11). https://doi.org/10.1056/
cat.23.0228. CMS. Synthesis of Evaluation Results
across 21 Medicare Models, 2012–2020. Fowler,
Ph.D. 2022. https://www.cms.gov/priorities/
innovation/data-and-reports/2022/wp-evalsynthesis-21models.
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amounts for covered physicians’
services, and update our payment
policies to address changes, including
changes in medical practice. In this
proposed rule, we are proposing to
incorporate key payment and service
delivery elements from CMS Innovation
Center models tested and evaluated over
the prior decade into permanent coding
and payment under the PFS.
Specifically, we are proposing to
recognize a primary care practice
delivery model trend which we will
refer to as ‘‘advanced primary care’’ and
which we propose to define using the
2021 National Academies of Sciences,
Engineering, and Medicine (NASEM)
report on Implementing High-Quality
Care as: ‘‘whole-person, integrated,
accessible, and equitable health care by
interprofessional teams that are
accountable for addressing the majority
of an individual’s health and wellness
needs across settings and through
sustained relationships with patients,
families, and communities.’’ 22 Using
this definition, we are proposing to
recognize the resources involved in
furnishing services using an ‘‘advanced
primary care’’ approach to care under
the PFS.23 Under this approach, the
delivery of care is supported by a teambased care structure and involves a
restructuring of the primary care team,
which includes the billing practitioner
and the auxiliary personnel under their
general supervision, within practices.
This restructuring creates several
advantages for patients, and provides
more broad accessibility and alternative
methods for patients to communicate
with their care team/practitioner about
their care outside of in-person visits (for
example, virtual, asynchronous
interactions, such as online chat), which
can lead to more timely and efficient
identification of, and responses to,
health care needs (for example,
practitioners can route patients to the
optimal clinician and setting—to a
synchronous visit, an asynchronous
chat, or a direct referral to the optimal
22 National Academies of Sciences, Engineering,
and Medicine. 2021. Implementing high-quality
primary care: Rebuilding the foundation of health
care. Washington, DC: The National Academies
Press. https://doi.org/10.17226/25983.
23 Team-based approaches to care can achieve
improved provider and care team satisfaction,
improved team communication, improved patient
safety, and improved patient and family
engagement in care. Coleman, M. Dexter. D., &
Nankivill, N. (2015, August). Factors affecting
physician satisfaction and Wisconsin Medical
Society strategies to drive change. Wisconsin
Medical Journal. 114(4), 135–142. Retrieved from
https://www.wisconsinmedicalsociety.org/
professional/wmj/archives/volume-114-issue-4august-2015/.
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site of care).24 Practitioners using an
advanced primary care delivery model
can more easily collaborate across
clinical disciplines through remote
interprofessional consultations with
specialists as well as standardize
condition management into evidencebased clinical workflows, which allow
for closed-loop follow-up and more realtime management for patients with
acute or evolving complex issues.
Practitioners can then use synchronous
interactions to build rapport with
patients and families, partner on
complex decisions, and personalize
their patients’ care plans.
Specifically, we are proposing to
adopt coding and payment policies to
recognize advanced primary care
management (APCM) services for use by
practitioners who are providing services
under this specific model of advanced
primary care, when the practitioner is
the continuing focal point for all needed
health care services and responsible for
all primary care services. This new
proposed coding and payment makes
use of lessons learned from the CMS
Innovation Center’s testing of a series of
advanced primary care models, such as
Comprehensive Primary Care (CPC),25
Comprehensive Primary Care Plus
(CPC+),26 and Primary Care First
(PCF) 27 28 (see discussion in section
II.G.2.a.(1) in this proposed rule) to
inform the elements upon which the
delivery of APCM services under an
advanced primary care delivery model
depend. As detailed below in sections
II.G.2.b. through II.G.2.d., this proposed
coding and payment will incorporate
elements of several specific, existing
care management and communication
technology-based services (CTBS) into a
bundle of services, that reflects the
essential elements of the delivery of
advanced primary care, for payment
under the PFS starting in 2025.
In the context of the proposal, we are
also interested in feedback on other
related policies for our consideration in
future rulemaking. To gather
24 Ellner, A., Basu, N. & Phillips, R.S. From
Revolution to Evolution: Early Experience with
Virtual-First, Outcomes-Based Primary Care. J GEN
INTERN MED 38, 1975–1979 (2023). https://
doi.org/10.1007/s11606-023-08151-1.
25 https://www.cms.gov/priorities/innovation/
innovation-models/comprehensive-primary-careinitiative.
26 https://www.cms.gov/priorities/innovation/
innovation-models/comprehensive-primary-careplus.
27 https://www.cms.gov/priorities/innovation/
innovation-models/primary-care-first-modeloptions.
28 Finke, Bruce, et al. ‘‘Addressing Challenges in
Primary Care—Lessons to Guide Innovation.’’ JAMA
Health Forum, vol. 3, no. 8, 19 Aug. 2022, p.
e222690, https://doi.org/10.1001/jamahealthforum.
2022.2690.
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information from interested parties to
inform potential future proposals, we
have included an Advanced Primary
Care Hybrid Payment Request for
Information (RFI) (Advanced Primary
Care RFI) in this proposed rule. The
Advanced Primary Care RFI seeks
feedback on whether and how we
should consider additional payment
policies that reflect our efforts to
recognize the delivery of advanced
primary care, including bundling of
additional individual services, which
may currently be furnished together as
primary care services but paid
separately. This focused approach to
seeking feedback on advanced primary
care payment policies is an important
step in our ongoing efforts to emphasize
accountable care and supports CMS’
goal of having 100 percent of
Traditional Medicare beneficiaries in
accountable care relationships by
2030.29
In addition to recognizing advanced
primary care, this proposed rule also
recognizes physician and practitioner
work that draws from evidence
generated by the CMS Innovation
Center’s Million Hearts® model.30 The
Million Hearts® model found that
quantitative assessment of patients’
atherosclerotic cardiovascular disease
(ASCVD) risk and providing high-risk
beneficiaries with cardiovascularfocused care management services
improved quality of care, including
mortality.31 We discuss a proposal in
this section to establish coding and PFS
payment for these services based in part
on the evidence generated by the
Million Hearts® model.
2. Advanced Primary Care Management
(APCM) Services (HCPCS Codes
GPCM1, GPCM2, and GPCM3)
a. Background
We have been analyzing opportunities
to strengthen and invest in primary care
in alignment with the goals of the U.S.
Department of Health and Human
Services (HHS) Initiative to Strengthen
Primary Care.32 Research has
29 CMS White Paper on CMS Innovation Center’s
Strategy: Driving Health System Transformation—A
Strategy for the CMS Innovation Center’s Second
Decade (https://www.cms.gov/priorities/innovation/
strategic-direction-whitepaper).
30 https://www.cms.gov/priorities/innovation/
innovation-models/million-hearts-cvdrrm.
31 Peterson G, Steiner A, Powell R, et al.
Evaluation of the Million Hearts® Cardiovascular
Disease Risk Reduction Model: Fourth Annual
Report. Mathematica. February 2022. https://
www.cms.gov/priorities/innovation/data-andreports/2022/mhcvdrrm-fourthannevalrpt.
32 U.S. Department of Health and Human
Services. (2023). Primary Care: Our First Line of
Defense. https://www.hhs.gov/sites/default/files/
primary-care-issue-brief.pdf.
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demonstrated that greater primary care
physician supply is associated with
improved population-level mortality
and reduced disparities,33 and also, that
establishing a long-term relationship
with a primary care provider leads to
reduced emergency department (ED)
visits,34 improved care coordination,
and increased patient satisfaction.35
HHS recognizes that effective primary
care is essential for improving access to
healthcare, for the health and wellbeing
of individuals, families, and
communities, and for achieving health
equity. The first coordinated set of HHSwide actions to strengthen primary care,
as part of the Initiative, is in primary
care payment; for example, adjusting
payment to ensure it supports delivery
of advanced primary care. CMS
Innovation Center models, described in
section II.G.2.a.(1) in this proposed rule,
reflect the ongoing work within HHS
and the unified, comprehensive
approach to HHS primary care activities
that we are accomplishing through our
current statutory authorities and
funding.
Over the last decade, we have
updated PFS payment policies as
appropriate, and we remain committed
to improving how Medicare payment
recognizes the resources involved in
furnishing covered services that
encompass aspects of advanced primary
care furnished by interprofessional care
teams and typically concentrating on
the delivery of appropriate preventive
care to patients and the management of
individuals’ chronic conditions as they
progress over time. As part of the CY
2014 PFS final rule, we reaffirmed our
support of primary care and recognized
care management as one of the critical
components of primary care that
contributes to better health outcomes for
individuals and reduced expenditure
growth, and explained our prioritization
of the development and implementation
of several initiatives (such as those
33 Basu S, Berkowitz SA, Phillips RL, Bitton A,
Landon BE, Phillips RS. Association of Primary
Care Physician Supply With Population Mortality
in the United States, 2005–2015. JAMA Intern Med.
2019;179(4):506–514. doi:10.1001/
jamainternmed.2018.7624. https://
jamanetwork.com/journals/jamainternalmedicine/
fullarticle/2724393.
34 Willemijn L.A. Schäfer et al, ‘‘Are People’s
Health Care Needs Better Met When Primary Care
Is Strong? A Synthesis of the Results of the
QUALICOPC Study in 34 Countries,’’ Primary
Health Care Research and Development 20 (2019):
e104. https://www.ncbi.nlm.nih.gov/pmc/articles/
PMC6609545/.
35 Michael J. van den Berg, Tessa van Loenen, and
Gert P Westert, ‘‘Accessible and Continuous
Primary Care May Help Reduce Rates of Emergency
Department Use: An International Survey in 34
Countries,’’ Family Practice 33, no. 1 (Feb. 2016):
42–50. https://academic.oup.com/fampra/article/
33/1/42/2450446.
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discussed in section II.G.2.a.(1) in this
proposed rule) (77 FR 68978). Since
then, we have implemented coding and
payment for many care management
services to better recognize the
resources involved in furnishing
medically necessary care management
activities that generally are performed
outside the context of a face-to-face, inperson visit—most often by the billing
practitioner’s clinical staff on behalf of
patients with complex health care
needs, including transitional care
management in the CY 2013 PFS final
rule (77 FR 68979); non-complex and
complex chronic care management
(CCM) in the CY 2015, 2017, and 2019
PFS final rules (78 FR 74414, 83 FR
58577, and 81 FR 80244); and principal
care management (PCM) in the CY 2020
PFS final rule (84 FR 62962). The CCM
and PCM code families now include 5
sets of codes which are reported
monthly on a timed basis, each set with
a base code of 20 to 60 minutes and an
add-on code for each additional 30
minutes. The code sets vary by the
degree of complexity of patient
conditions (that is, non-complex and
complex CCM for multiple chronic
conditions or PCM for a single high-risk
condition), and whether the number of
minutes spent by clinical staff or the
physician or non-physician practitioner
(NPP) is used to meet time thresholds
for billing.
Additionally, we have established
coding and payment for certain services
where a medical professional evaluates
a patient’s medical information
remotely using communication
technology. As discussed in the CY
2019 PFS final rule, this set of services
is defined by and inherently involves
the use of communications technology,
and includes certain remote patient
monitoring services, virtual check-in
services, remote evaluation of prerecorded patient information, remote
interpretations of diagnostic imaging
tests, and interprofessional
consultations. We recognize that
technological advances have changed
and continue to change the practitionerpatient care delivery interaction. We
have recognized these technologyenabled interactions through separately
billable CTBS over the last several years.
However, we acknowledge, as we learn
more about how advanced primary care
services are furnished to patients, that
in some clinical care delivery scenarios,
practitioners furnishing the type of care
highlighted in this discussion may
furnish certain aspects of the CTBS
services in complement to care
management services (for example, by
allowing interprofessional care teams to
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answer patient questions, refer patients
to higher levels of care, view and
interpret patient images, order needed
treatments, and offer reassurance or
advice), in an effort to more efficiently
manage the quantity and quality of
medical information that is necessary to
support effective patient-centered
treatment plans.
Despite these important steps to pay
separately for these care management
services, there has been limited uptake
of care management services and
Medicare still overwhelmingly pays for
primary care through traditional office/
outpatient (O/O) Evaluation and
Management (E/M) visit codes, which
describe a broad range of physicians’
services but do not fully distinguish and
account for the resources associated
with primary care and other
longitudinal care. As we stated in the
CY 2024 PFS final rule, we believe that
because E/M visit codes are intended to
be used very broadly, the complexity of
services required to provide this type of
care is not fully incorporated as part of
the valuation of the work RVUs when
the E/M code itself is used as the
primary way to report the work of the
professional (88 FR 78972). In the CY
2024 PFS final rule, we took steps to
better recognize the inherent complexity
of visits associated with primary and
longitudinal care of patients by
finalizing a new add-on code (HCPCS
code G2211) for use by practitioners
furnishing services as the continuing
focal point for all the patient’s needed
health care services, such as a primary
care practitioner (88 FR 78969). When
furnishing primary and longitudinal
care, practitioners must be attuned to
the factors that develop and maintain
trusting practitioner-patient
relationships that enable effective
diagnosis, management, and treatment
on an ongoing basis. In finalizing the O/
O E/M visit complexity add-on code, we
recognized the feedback from interested
parties indicating that the care
management codes alone may not have
mitigated the deficiencies in the ability
of existing E/M codes to reflect the time
and resources involved in furnishing
visits in the context of longitudinal
care—of which, advanced primary care
is one model. Many commenters
responded, as reflected in the CY 2024
PFS final rule, that they did not view
the coding and payment currently
available under the PFS as capable of
recognizing the broad range of elements
that define primary care (88 FR 52326).
Other commenters responded that they
did not believe that the existing E/M
service codes alone reflect the work and
resources involved in furnishing non-
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procedural care to Medicare
beneficiaries (88 FR 78976).
Over the years, interested parties have
focused attention on the ongoing need
to improve how practitioners are paid,
in and outside of payment bundles,
including but not limited to the
possibility of E/M codes designed
specifically to be billed in conjunction
with care management codes and the
elimination of multiple disparities
between the payment for E/M services
in global periods and those furnished
individually. Based on feedback from
the physician and practitioner
community, we understand that
advanced primary care encompasses the
work of interprofessional teams who are
accountable for addressing the majority
of an individual’s health and wellness
needs across settings and through
sustained relationships, which
necessarily involves time spent by
primary care practitioners and their
clinical staff outside of individual E/M
visits.
As with many services paid under the
PFS, we balance making payment that
recognizes and supports technological
developments in healthcare and the
resources involved in evolving medical
practice to allow for appropriate and
expanded access to innovative
technologies and newer services with
promoting stability and efficiency in
coding and billing rules for practitioners
and institutions. We recognize the
important role of gathering input and
information from the CMS Innovation
Center models (described in more detail
in section II.G.2.a.(1) in this proposed
rule), comment solicitations, research
from other public and private entities,
the work of all parties involved in
furnishing primary care, and from the
public at large. As previously noted,
interested parties have given ample
feedback over the years to inform our
recognition of care management
services; for example, as part of the CY
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2022 PFS rulemaking, interested parties
specifically requested our consideration
of a ‘‘30-day global period bundling care
management services’’ and we
responded that we would consider this
suggestion for future rulemaking (86 FR
65118). We have continued to
incorporate feedback into our
rulemaking and strengthen our care
management code sets with the goal of
better recognizing the elements of
advanced primary care as part of a
multi-year strategy. Based on this
feedback, we are proposing to establish
a set of codes to better describe
advanced primary care management
services broadly, to provide more
stability in payment and coding for
practitioners in the context of continued
evolution in advanced primary care, as
well as to provide us with a mechanism
for continued and intentional
improvements to advanced primary care
payment.
(1) Key Care Delivery Methods in Select
CMS Innovation Center Models
We have prioritized the
implementation or testing of a series of
initiatives designed to improve payment
for, and encourage long-term investment
in, primary care and care management
services. By supporting enhanced care
management and coordination, these
initiatives contributed to the growing
practice of advanced primary care and
have also provided valuable lessons
learned that we are incorporating into
our proposals.
Several CMS Innovation Center
models address payment for care
management services and CTBS. The
CPC initiative,36 the CPC+ model,37 and
the PCF model 38 all included payments
36 https://downloads.cms.gov/files/cmmi/CPCinitiative-fourth-annual-report.pdf.
37 https://www.cms.gov/priorities/innovation/
data-and-reports/2023/cpc-plus-fifth-annual-evalreport.
38 Evaluation of the Primary Care First Model.
February 2024. https://www.cms.gov/priorities/
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for care management services that
closely aligned with the care
management services included in the
PFS. In these initiatives, primary care
practices received risk-adjusted, per
beneficiary per month (PBPM) payments
for care management services furnished
to Medicare FFS beneficiaries attributed
to their practices. These model
payments were designed to offer
practices a stable, predictable revenue
stream that supported required
infrastructure and appropriately
compensated practices for the enhanced
services they would provide. Practices
participating in CPC+ consistently cited
these payments as the most useful type
of model payment support they
received; these stable, prospectively
paid payments typically served as the
main funding source for compensating
care managers, behavioral health
providers, and other staff hired to
improve care delivery.39 Because these
payments were paid prospectively and
could be used to support a range of care
management and coordination
activities, they provided participants
with greater financial stability and
flexibility to develop and expand
capabilities to meet patients’ care
needs.40 Table 19 identifies a number of
CMS Innovation Center models and key
care delivery methods from each.41
BILLING CODE P
innovation/data-and-reports/2024/pcf-second-evalrpt.
39 O’Malley A, Singh P, Fu N, et al. Independent
Evaluation of the Comprehensive Primary Care Plus
(CPC+): Final Report. Mathematica. December 2023.
https://www.cms.gov/priorities/innovation/dataand-reports/2023/cpc-plus-fifth-annual-eval-report.
40 O’Malley A, Singh P, Fu N, et al. Independent
Evaluation of the Comprehensive Primary Care Plus
(CPC+): Final Report. Mathematica. December 2023.
https://www.cms.gov/priorities/innovation/dataand-reports/2023/cpc-plus-fifth-annual-eval-report.
41 For more information on how the Innovation
Center is supporting primary care, https://
www.cms.gov/files/document/primary-careinfographic.pdf.
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61701
AIM provided an opportunity for
participants to invest in care
transformation activities.
Specifically, AIM was an
opportunity for independent
Evaluation of the Accountable Care
primary care practices in rural
Organization Investment Model,
communities to hire population
Final Report, September 2020,
ACO Investment Model (AIM)
health staff, such as care managers
available at:
https://www.ems.gov/priorities/inno
or outreach coordinators. Care
vation/data-and-reports/2020/aimmanagers conducted outreach,
final-annrpt
scheduling, and patient education.
Care managers did this through a
variety of mechanisms including
phone, in the physician office, and
via
home visits.
·----------- ---------- --------------------------·--- --·--- --· --------·--·-··
------ --- - - - - - - - -------------" -------·-----·-·
CPC practices provided
longitudinal and episodic care
management services for patients at
high or rapidly increasing risk
Evaluation of the Comprehensive
whom the practices believed were
Primary Care Initialive, Fourth
most likely to benefit from
Annual Report, May 2018,
intensive support. By 2016, CPC
practices risk stratified 95% of their available at:
empaneled patients, and provided
https ://downloads.ems. gov/files/cm
care management to 20% of those
mi/CPC-initiative-fourth-annualpatients. CPC practices also greatly report.p4fhttps://downloads.cms.go
increased their use of dedicated care v/files/cmmi/CPC-initiative:fourthComprehensive Primary Care
managers over time. By 2016, 89% annual-report.pdf
(CPC)
of practices reported that, "care
managers who were members of the Long-Term Effects of the
[primary care] practice team
Comprehensive Primary Care
systematically provided care
Model on Health Care Spending
management services to high-risk
and Utilization. May 2022.
patients" - an increase from 20% in Available at:
20 I2. Beneficiaries attributed to
https :/lwww.ncbi.nlm.nih.gov/pmc/a
CPC practices had slower growth in rticles/PMC9130381/.
hospitalizations and emergency
department (ED) visits than those
being managed by practices not in
the model.
CPC+ practices used data and teambased care to proactively identify
the needs of their patients and
efficiently manage their care.
Additionally, by the final year of
Independent Evaluation of
the model, about 97% of physicians Comprehensive Primary Care Plus.
in CPC+ and comparison practices
Final Report, December 2023,
Comprehensive Primary Care
reporled Lhe use of scheduled
available al:
Plus (CPC+)
phone, video, or e-visits for at least https :/lwww. cms.govlpriorities/inno
vation/data-and-reports/2023/cpcsome of their patients. Finally,
CPC+ had small favorable effects
plus-fifth-annual-eval-report.
on some claims-based, quality-ofcare measures of planned care and
population health and patient and
___ca_r_e_iverengagAm_e_n_t._ _ _ _ _~--------------------------
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TABLE 19: Key Care Delivery Methods from Select CMS Innovation Center
Models
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Primary Care First (PCF)
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b. Proposed HCPCS G-Codes for
Advanced Primary Care Management
(APCM)
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We are proposing to establish coding
and make payment under the PFS for a
newly defined set of APCM services
described and defined by three new
HCPCS G-codes. To recognize the
resource costs associated with
furnishing APCM services to Medicare
beneficiaries, we are proposing to
establish and pay for three new G-codes
that describe a set of care management
services and CTBS furnished under a
broader application of advanced
primary care. This new coding and
payment would reflect the recognized
effectiveness and growing adoption of
the advanced primary care approach to
care.42 It would also encompass a
broader range of services and simplify
the billing and documentation
requirements, as compared to existing
care management and CTBS codes, for
clinicians who care for their patients
using an advanced primary care model.
We recognize that there are primary care
physicians, practitioners, and practices
beyond those that have participated in
CMS Innovation Center primary care
models (such as those discussed in
section II.G.2.a.(1) in this proposed
42 National Academies of Sciences, Engineering,
and Medicine (NASEM). 2021. Implementing highquality primary care: Rebuilding the foundation of
health care. Washington, DC: The National
Academies Press. https://doi.org/10.17226/25983.;
Maeng DD et al. Reducing long-term cost by
transforming primary care: evidence from
Geisinger’s medical home model. Am J Manag Care.
2012 Mar;18(3):149–55. PMID: 22435908. Available
here: https://pubmed.ncbi.nlm.nih.gov/22435908.;/
Jones C et al. Vermont’s Community-Oriented AllPayer Medical Home Model Reduces Expenditures
and Utilization While Delivering High-Quality Care.
Popul Health Manag. 2016;19(3):196–205. Available
here: https://www.ncbi.nlm.nih.gov/pmc/articles/
PMC4913508/.
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rule), that may incur resource costs
associated with their treatment of
patients based on the advanced primary
care delivery model. Providing care
using an advanced primary care
delivery model involves resource costs
associated with maintaining certain
practice capabilities and continuous
readiness and monitoring activities to
support a team-based approach to care,
where significant resources are used on
virtual, asynchronous patient
interactions, collaboration across
clinical disciplines, and real-time
management of patients with acute and
complex concerns, that are not fully
recognized or paid for by the existing
care management codes. We have
observed medical practice trends in
primary care for several years. We note
that in prior rulemaking, for example, in
the CY 2013 PFS final rule, we stated,
‘‘we further consider[ed] how advanced
primary care practices can fit within a
fee-for-service model’’ (77 FR 68987),
and in the CY 2015 PFS final rule, we
stated our commitment ‘‘to supporting
advanced primary care, including the
recognition of care management as one
of the critical components of primary
care that contributes to better health for
individuals and reduced expenditure
growth’’ (79 FR 67715). In the CY 2017
PFS final rule, we discussed changes to
retain elements of the CCM service that
are ‘‘most characteristic of the changes
in medical practice toward advanced
primary care’’ (81 FR 80251). As the
delivery of primary care has evolved to
embrace advanced primary care more
fully, we believe that it is prudent to
now adopt specific coding and payment
policy to better recognize the resources
involved in care management under an
advanced primary care delivery model.
Below, we explain the proposed new
codes and their descriptors. In the next
section, we propose to define the
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second-eval-rpt.
elements of the scope of service for
APCM that would be required for a
practitioner to bill Medicare for the
APCM service, and we explain the
proposed standards for practices that
furnish APCM services to ensure that
the physicians and practitioners who
bill for these services have the
capability to fully furnish advanced
primary care, including APCM services
(see section II.G.2.c. of this proposed
rule). At this time, we are proposing to
identify specific care management and
CTBS services that are a part of
advanced primary care delivery and
would be bundled into the PFS payment
for the APCM services. As such, we will
identify the services that we are
proposing would overlap substantially
with the new codes and which would
not be separately billable with the
APCM codes under our proposal (see
section II.G.2.d. of this proposed rule).
Finally, we propose to establish relative
values for these codes for purposes of
payment under the PFS (see section
II.G.2.e. of this proposed rule).
We are proposing to establish the
following G-codes and descriptors for
APCM services, and as explained in the
next section, due to the similar scope of
APCM and other care management and
CTBS services, we are proposing to
include some of the same language from
the CCM and PCM service elements in
the APCM code descriptors, as well as
emphasize that certain practice
capabilities and requirements are
inherent in these elements and must be
met in order to bill for APCM services:
HCPCS code GPCM1 (Advanced
primary care management services
provided by clinical staff and directed
by a physician or other qualified health
care professional who is responsible for
all primary care and serves as the
continuing focal point for all needed
health care services, per calendar
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access to a care team practitioner
with real-time access to an
electronic health record (EHR).
Practices also provide risk-stratified
care management for all empaneled
patients and ensure beneficiaries
receive timely follow-up contact
from the practice after ED visits
and hospitalizations. Practices
commonly report expanding their
practice care team by hiring
additional clinical and non-clinical
staff to bolster longitudinal care
mana ement services.
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month, with the following elements, as
appropriate:
• Consent;
++ Inform the patient of the
availability of the service; that only one
practitioner can furnish and be paid for
the service during a calendar month; of
the right to stop the services at any time
(effective at the end of the calendar
month); and that cost sharing may
apply.
++ Document in patient’s medical
record that consent was obtained.
• Initiation during a qualifying visit
for new patients or patients not seen
within 3 years;
• Provide 24/7 access for urgent
needs to care team/practitioner,
including providing patients/caregivers
with a way to contact health care
professionals in the practice to discuss
urgent needs regardless of the time of
day or day of week;
• Continuity of care with a designated
member of the care team with whom the
patient is able to schedule successive
routine appointments;
• Deliver care in alternative ways to
traditional office visits to best meet the
patient’s needs, such as home visits
and/or expanded hours;
• Overall comprehensive care
management;
++ Systematic needs assessment
(medical and psychosocial).
++ System-based approaches to
ensure receipt of preventive services.
++ Medication reconciliation,
management and oversight of selfmanagement.
• Development, implementation,
revision, and maintenance of an
electronic patient-centered
comprehensive care plan;
++ Care plan is available timely
within and outside the billing practice
as appropriate to individuals involved
in the beneficiary’s care, can be
routinely accessed and updated by care
team/practitioner, and copy of care plan
to patient/caregiver;
• Coordination of care transitions
between and among health care
providers and settings, including
referrals to other clinicians and followup after an emergency department visit
and discharges from hospitals, skilled
nursing facilities or other health care
facilities as applicable;
++ Ensure timely exchange of
electronic health information with other
practitioners and providers to support
continuity of care.
++ Ensure timely follow-up
communication (direct contact,
telephone, electronic) with the patient
and/or caregiver after an emergency
department visit and discharges from
hospitals, skilled nursing facilities, or
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other health care facilities, within 7
calendar days of discharge, as clinically
indicated.
• Ongoing communication and
coordinating receipt of needed services
from practitioners, home- and
community-based service providers,
community-based social service
providers, hospitals, and skilled nursing
facilities (or other health care facilities),
and document communication
regarding the patient’s psychosocial
strengths and needs, functional deficits,
goals, preferences, and desired
outcomes, including cultural and
linguistic factors, in the patient’s
medical record;
• Enhanced opportunities for the
beneficiary and any caregiver to
communicate with the care team/
practitioner regarding the beneficiary’s
care through the use of asynchronous
non-face-to-face consultation methods
other than telephone, such as secure
messaging, email, internet, or patient
portal, and other communicationtechnology based services, including
remote evaluation of pre-recorded
patient information and
interprofessional telephone/internet/
EHR referral service(s), to maintain
ongoing communication with patients,
as appropriate;
++ Ensure access to patient-initiated
digital communications that require a
clinical decision, such as virtual checkins and digital online assessment and
management and E/M visits (or e-visits).
• Analyze patient population data to
identify gaps in care and offer
additional interventions, as appropriate;
• Risk stratify the practice population
based on defined diagnoses, claims, or
other electronic data to identify and
target services to patients;
• Be assessed through performance
measurement of primary care quality,
total cost of care, and meaningful use of
Certified EHR Technology.).
HCPCS code GPCM2 (Advanced
primary care management services for a
patient with multiple (two or more)
chronic conditions expected to last at
least 12 months, or until the death of
the patient, which place the patient at
significant risk of death, acute
exacerbation/decompensation, or
functional decline, provided by clinical
staff and directed by a physician or
other qualified health care professional
who is responsible for all primary care
and serves as the continuing focal point
for all needed health care services, per
calendar month, with the elements
included in GPCM1, as appropriate) and
HCPCS code GPCM3 (Advanced
primary care management services for a
patient that is a Qualified Medicare
Beneficiary with multiple (two or more)
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chronic conditions expected to last at
least 12 months, or until the death of
the patient, which place the patient at
significant risk of death, acute
exacerbation/decompensation, or
functional decline, provided by clinical
staff and directed by a physician or
other qualified health care professional
who is responsible for all primary care
and serves as the continuing focal point
for all needed health care services, per
calendar month, with the elements
included in GPCM1, as appropriate).
HCPCS codes GPCM1 through GPCM3
would describe APCM services
furnished per calendar month, following
the initial qualifying visit (see section
II.G.2.c.(1) for more on the initiating
visit). Physicians and NPPs, including
nurse practitioners (NPs), physician
assistants (PAs), certified nurse
midwives (CNMs) and clinical nurse
specialists (CNSs), could bill for APCM
services. As we will describe in more
detail in section II.G.2.c., within the
code descriptors for GPCM1, GPCM2,
and GPCM3, we are including the
elements of the scope of service for
APCM as well as the practice
capabilities and requirements that we
believe to be inherent to care delivery
by the care team/practitioner who is
billing under a practice using an
advanced primary care delivery model,
and necessary to fully furnish and,
therefore, bill for APCM services.
As described in more detail below,
within the code descriptors for GPCM1,
GPCM2, and GPCM3, we are proposing
that the practitioner who bills for APCM
services intends to be responsible for
the patient’s primary care and serves as
the continuing focal point for all needed
health care services. We anticipate that
most practitioners furnishing APCM
services will be managing all the
patient’s health care services over the
month and have either already been
providing ongoing care for the
beneficiary or have the intention of
being responsible for the patient’s
primary care and serving as the
continuing focal point for all the
patient’s health care services. We
anticipate that these codes will mostly
be used by the primary care specialties,
such as general medicine, geriatric
medicine, family medicine, internal
medicine, and pediatrics, but we are
also aware that, in some instances,
certain specialists function as primary
care practitioners—for example, an OB/
GYN or a cardiologist. In contrast to
situations where the patient’s overall,
ongoing care is being managed,
monitored, and/or observed by a
practitioner, we believe that there are
situations when care is provided by a
practitioner who would not serve as
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‘‘the continuing focal point for all
needed health care services.’’
Similarly, there are some time- or
condition-limited practitioner-patient
relationships that are clearly not
indicative of the ongoing care that we
anticipate practitioners would be
responsible for when furnishing APCM
services. As we stated in the CY 2021
PFS proposed rule and CY 2024 PFS
final rule in the context of our policies
for the O/O E/M visit complexity addon code (HCPCS code G2211), a
practitioner 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 of 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, 88 FR 78971). For example,
a patient who spends one month of the
year in another location could require
physicians’ services in that location if
they experience exacerbation of one of
their chronic conditions, but the
practitioner who treats them would not
intend to manage or monitor that
patient’s overall, ongoing care. Finally,
HCPCS code G2211 can also be billed
when medical services are ‘‘part of
ongoing care related to a patient’s
single, serious condition or complex
condition,’’ but this is different from the
APCM requirement. A practitioner’s
management of one or more serious
conditions (as is often the case with
specialty care), without more, does not
mean that the practitioner is also
responsible for all primary care services
and the focal point for all needed care
(the requirement for APCM), and thus
would not necessarily mean that the
practitioner could bill for APCM.
As is our current policy for other care
management services, and consistent
with both CPT guidance and Medicare
rules for CPT codes 99487, 99489,
99490, we are proposing that HCPCS
codes GPCM1, GPCM2, and GPCM3
may only be reported once per service
period (calendar month) and only by the
single practitioner who assumes the care
management role with a particular
beneficiary for the service period. That
is, based on a patient’s status, a
physician or practitioner would identify
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the patient to receive Level 1, Level 2,
or Level 3 APCM services during a given
service period (calendar month), and we
would make payment for only one claim
for APCM services for that service
period. At this time, we do not see the
need or value of proposing restrictions
or complex operational mechanisms to
identify a single physician or NPP who
may bill for APCM services for a
specific beneficiary. However, we
recognize that other initiatives, such as
the Medicare Shared Savings program,
have operational mechanisms in place
to attribute patients to certain ACOs
(§ 425.400). While a similar approach
could be used to attribute patients for
APCM services, we are reluctant to
introduce unnecessary complexity for
these services. As we continue to
develop our policies in this area, we are
seeking feedback from interested parties
on methodologies that could allow for
identification of the beneficiary’s
primary care practitioner. We are also
seeking comment on whether there
should be additional requirements to
prevent potential care fragmentation or
service duplication.
We anticipate that APCM services
would ordinarily be provided by
clinical staff incident to the professional
services of the billing practitioner in
accordance with our regulation at
§ 410.26. We are proposing that APCM
services would be considered a
‘‘designated care management service’’
under § 410.26(b)(5) and, as such, could
be provided by auxiliary personnel
under the general supervision of the
billing practitioner.
Unlike the current coding to describe
care management services, we are
further proposing that the code
descriptors for GPCM1, GPCM2, and
GPCM3 would not be time-based. Based
on feedback from the physician and
practitioner community, we understand
that ongoing care management and
coordination services are standard parts
of advanced primary care, even in
months when documented clinical staff
or billing professional minutes may not
reach the required thresholds for billing
or the patient’s condition does not meet
the clinical conditions for care
management services under the existing
code set. In consideration of the
extensive feedback from interested
parties, we have learned that
practitioners who currently furnish
monthly care management services may
already be providing APCM services in
a variety of clinical circumstances,
documenting all necessary aspects of
the patient-centered care furnished
monthly to the patient without meeting
the requirements to bill for care
management services, such as satisfying
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the administrative requirement to count
clinical staff minutes to reach specific
time-based thresholds. As we stated in
the CY 2024 PFS final rule in the
context of the O/O E/M visit complexity
add-on code (HCPCS code G2211),
primary care physicians may diagnose
and treat a condition in an O/O E/M
visit that is not expected to last as long
as three months or would not
reasonably be expected to result in a
risk of hospitalization, and the
practitioner’s clinical staff may provide
significant care management and
coordination services relating to that
condition. For example, COVID–19
cases are clinical circumstances that
generally do not last three months but
may require significant acute
management, care coordination, and
follow-up within a given month,
particularly for patients with
comorbidities (88 FR 78973).
Practitioners may also provide care
management and coordination services
to a patient whose condition meets the
criteria in one or more care management
codes, but the documented minutes of
service may not reach the minimum
time threshold to bill for a care
management service. For example, the
practitioner might provide care
coordination for a month that includes
20 minutes of consulting with the
patient’s other healthcare providers and
modifying medications to address an
acute exacerbation of hypertension, but
would not meet the requirements for
billing the PCM service. We also note
that, unlike the current coding to
describe certain CTBS services, we are
proposing that the code descriptors for
GPCM1, GPCM2, and GPCM3 would not
include the timeframe restrictions for
billing certain CTBS (for example, the
restriction for virtual check-in services
that there is not a related E/M service
provided within the previous 7 days or
an E/M service or procedure within the
next 24 hours or the soonest available
appointment). As addressed in the
CY2019 Final Rule, we have heard from
interested parties that the timeframe
restrictions for billing certain CTBS are
administratively burdensome (83 FR
59686).
We are also proposing that not all
elements included in the code
descriptors for APCM services must be
furnished during any given calendar
month for which the service is billed.
APCM services are largely designed to
be person-centered and focused on the
individual patient, such that the
elements that are provided depend on
medical necessity and individual
patient need. Therefore, we anticipate
that all the APCM scope of service
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elements (for example, comprehensive
care management and care coordination)
will be routinely provided, as deemed
appropriate for each patient,
acknowledging that not all elements
may be necessary for every patient
during each month (for example, the
beneficiary may have no hospital
admissions that month, so there is no
management of a care transition after
hospital discharge). We also anticipate
that there may be some months where
it may be appropriate for some service
elements to be performed more than
once for the patient. For example, in one
month a patient with heart failure and
chronic kidney disease receiving APCM
Level 2 services (GPCM2) may be on a
stable medication regimen, receive
communication about their care plan,
but no virtual check-ins. The next
month, the patient may experience a
heart failure exacerbation requiring
inpatient admission, and then receive as
part of their APCM service timely
communication and follow-up with new
labs ordered, multiple virtual check-ins
ensuring that the patient understands
their new medications, a phone call to
help the patient understand the lab
results, and an interprofessional
consultation with the patient’s
cardiologist to help decide if the
patient’s diuretic dosage should be
changed.
However, even if not all elements of
the APCM service are furnished each
month for which APCM is billed, we
propose that billing practitioners and
auxiliary personnel must have the
ability to furnish every service element
and furnish these elements as is
appropriate for any individual patient
during any calendar month. As
described in more detail in section
II.G.2.c. of this proposed rule, we
believe that maintaining certain
advanced primary care practice
capabilities and requirements is
inherent in these elements and must be
met to fully furnish and bill APCM. For
example, if in our previous example, the
patient with heart failure and chronic
kidney disease receiving Level 2 APCM
experiences swollen legs, the patient
should be able to submit a photo or
video to the practitioner via a secure
communications system, and the
practitioner must be able to interpret
and communicate remotely with the
patient about those images.
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While we are proposing that specific
minutes spent furnishing APCM
services for purposes of billing HCPCS
codes GPCM1–GPCM3 need not be
documented in the patient’s medical
record, we would expect that any
actions or communications that fall
within the APCM elements of service
would be described in the medical
record and, as appropriate, its
relationship to the clinical problem(s)
they are intended to resolve and the
treatment plan, just as all clinical care
is documented in the medical record.
We are seeking feedback on these
service descriptions, and on whether
there are elements of other care
management services that should be
removed or altered for purposes of
APCM services.
Finally, while the service descriptors
above are consistent across all three
APCM levels because the scope of
service elements are consistent across
all levels of APCM and the elements
that are provided depend on medical
necessity and individual patient need,
we are proposing that the APCM codes
would be stratified into three levels
based on certain patient characteristics
that are broadly indicative of patient
complexity and the consequent resource
intensity involved in the provision of
these services in the context of
advanced primary care. We are
proposing that the new APCM coding
schema would be stratified based on
APCM services being furnished using
the advanced primary care model to
patients with one or fewer chronic
conditions (‘‘Level 1’’); patients with
two or more chronic conditions (‘‘Level
2’’); and Qualified Medicare
Beneficiaries (QMBs) 43 with two or
more chronic conditions (‘‘Level 3’’)
(see Table 20 for the three APCM code
levels). This stratification of APCM into
three levels allows us to distinguish
among different levels of patient
43 See 42 CFR 435.123. The proposal includes
both individuals in the QMB eligibility group who
also have full scope Medicaid coverage (‘‘QMBplus’’) and individuals in the QMB eligibility group
who do not have Medicaid eligibility under any
other Medicaid coverage group (‘‘QMB-only’’).
However, this proposal would not include those
QMBs who are in the Medicare Part B
Immunosuppressive Drug benefit, which provides
coverage of immunosuppressive drugs based on
eligibility requirements described in § 407.55,
because such individuals would not qualify for
Medicare coverage of the services described in this
rulemaking. See 42 CFR 435.123(c)(2).
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complexity and more accurately reflect
the resources required to furnish APCM
services for certain categories of
beneficiaries. We anticipate that a
practitioner using the advanced primary
care model would bill for APCM
services for all or nearly all the patients
for whom they intend to assume
responsibility for primary care.
Furthermore, we recognize the ways
in which this new APCM coding
intersects with current care management
codes around number of chronic
conditions. We note that the current
care management codes are generally
stratified in a similar, though more
granular way, by the degree of
complexity of care based on the
presence of chronic conditions and
complexity of medical decision making,
who directly performs the service, and
the time spent furnishing the service. In
establishing separate payment for CCM
services in the CY 2014 PFS final rule,
we recognized that the resources
involved in furnishing comprehensive,
coordinated care management services
to patients with multiple (two or more)
chronic conditions were greater than
those included in a typical non-face-toface care management service, which we
continued to consider as bundled into
the payment for face-to-face E/M visits
(78 FR 43337). In the CY 2017 PFS final
rule, based on robust feedback from
interested parties indicating that the
new CCM codes did not fully capture
the service time required to furnish care
to beneficiaries with more complex
conditions, we finalized new codes for
patients with complex care management
needs. In the CY 2016 PFS final rule, in
considering how to improve the
accuracy of our payments for care
coordination, particularly for patients
requiring more extensive care
management, we stated that we believe
the care coordination and management
for Medicare beneficiaries with multiple
chronic conditions, a particularly
complicated disease or acute condition,
or certain behavioral health conditions
often requires extensive discussion,
information-sharing, and planning
between a primary care physician and a
specialist (for example, with a
neurologist for a patient with
Alzheimer’s disease plus other chronic
diseases) (80 FR 70919).
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TABLE 20: Patient-Centered Risk Stratification for Billin APCM Codes
Patients with two or more chronic
conditions.
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(1) Level 1 APCM
We are proposing the Level 1 APCM
code for patients with one or fewer
chronic conditions because of the
increased import and use of non-face-toface interactions in advanced primary
care even for patients with relatively
fewer health needs, which has increased
over time for several observable reasons,
including broad evolution in
information and communication
technology in everyday life, diffusion of
practices first adopted for higher-acuity
patients, and continuing practices
widely adopted during the COVID–19
pandemic that reduce reliance on inperson interactions. We believe APCM
services for a patient diagnosed with
one or fewer chronic conditions will
require significantly less time and
resources than one with two or more
chronic conditions since, in general,
there would be fewer ongoing health
needs and other health care resources to
coordinate, a lower risk of drug
interactions, and less complicated
physiology. Based on CY 2010 Medicare
claims data, the difference in annual
expenditures per beneficiary between
patients with one or fewer chronic
conditions and those with two or three
chronic conditions was $3,673.44 Our
current care management coding
similarly delineates patient complexity
between patients with a single serious
chronic condition (PCM codes) and
those with two or more serious chronic
conditions (CCM codes). We anticipate
that practitioners who would furnish
APCM services may have already had
experience with care management
services coding and payment for much
of this population. The Level 1 APCM
code would also address the current gap
in coding and payment for care
management services furnished using an
advanced primary care model for
patients without multiple chronic
conditions.
(2) Level 2 APCM
We are proposing the Level 2 APCM
code for patients with two or more
chronic conditions because of the
44 Centers for Medicare and Medicaid Services.
Chronic Conditions among Medicare Beneficiaries,
Chartbook, 2012 Edition. Baltimore, MD. 2012.
https://www.cms.gov/research-statistics-data-andsystems/statistics-trends-and-reports/chronicconditions/downloads/2012chartbook.pdf.
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Patients with two or more chronic
conditions and who are Qualified
Medicare Beneficiaries.
frequency of chronic conditions in the
Medicare population. In fact, nearly four
in five Medicare beneficiaries have two
or more chronic conditions.45
Furthermore, as noted previously, our
current care management coding
delineates patient complexity for the
CCM codes for patients with two or
more serious chronic conditions, and
we anticipate that practitioners who
would furnish APCM services may have
already had experience with care
management services coding and
payment for much of this population.
For example, someone with chronic
kidney disease and heart failure requires
regular check-ins, coordination with
specialty care, follow-up after hospital
admissions for heart failure
exacerbations, regular modifications of
the care plan, and more. These services
are typically described by the existing
CCM services. The patient may also
typically need to reach out more often
to their primary care practitioner with
questions or new symptoms via the
patient portal. For instance, the person
sends a message through the patient
portal to ask whether or not they should
come into the primary care office after
gaining ten pounds in the last week—
which could be a sign of increased fluid
retention and the need for increased
diuretic dosages to avoid pleural edema
(an accumulation of fluid in the lungs).
The primary care team books the patient
for a same-day urgent care appointment
to assess for signs of swelling and
pleural edema. Again, this on-demand
access to their primary care team can
help treat the patient’s chronic
conditions in a patient-centered way
and avoid unnecessary complications.
(3) Level 3 APCM
We are proposing the Level 3 APCM
code for patients with QMB status and
two or more chronic conditions based
on our understanding that people with
both multiple chronic conditions and
social risk factors generally require even
more time and resources from primary
care practitioners and their teams to
ensure that the patient’s chronic
conditions are managed appropriately
and effectively. We are proposing to use
45 Lochner, K., Goodman, R., Posner, S., & Parekh,
A. (n.d.). Multiple Chronic Conditions Among
Medicare Beneficiaries. CMS. https://www.cms.gov/
mmrr/Downloads/MMRR2013_003_03_b02.pdf.
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a patient’s QMB status as a method to
identify beneficiaries with social risk
factors that generally necessitate
relatively greater resource requirements
to effectively furnish advanced primary
care than people without such risk
factors. There is significant evidence
that such dually eligible beneficiaries,
on average, are more medically complex
and have higher healthcare needs; 46 for
example, dually eligible beneficiaries
are more likely to have poor functional
status 47 and recent expenditure data
found that the difference in Medicare
spending on a per person per year basis
between dually eligible and non-dually
eligible Medicare beneficiaries was
$13,198 in CY 2021.48
QMBs are the largest eligibility group
within the Medicare-Medicaid dually
eligible enrollee population, comprising
of 66 percent of the 12.8 million
individuals per the most recent
available data.49 For the approximately
8.5 million dually eligible beneficiaries
who are QMBs, Medicaid provides
assistance for patients to meet
Medicare’s cost-sharing requirements.
The QMB eligibility group helps to
ensure full access to the Medicare
benefit for the lowest income enrollees
by covering these costs. Individuals can
qualify for QMB status if their income
is below 100 percent of the Federal
Poverty Level ($15,300/year in 2024)
and assets are no more than $9,430/
$14,130 (one person/married couple in
2024), although states can request CMS
approval to disregard certain income
and assets.50 Beneficiaries apply for this
46 Kaiser Family Foundation. (n.d.). A primer on
Medicare: What is the role of Medicare for dualeligible beneficiaries? Retrieved June 24, 2024, from
https://www.kff.org/report-section/a-primer-onmedicare-what-is-the-role-of-medicare-for-dualeligible-beneficiaries/#:∼:text=A%20larger%20
share%20of%20dual,beneficiaries%3B%20
and%20more%20than%20half%20(.
47 ASPE. Report to Congress: Social Risk Factors
and Performance Under Medicare’s Value-Based
Purchasing Programs. December 2016. https://
aspe.hhs.gov/reports/report-congress-social-riskfactors-performance-under-medicares-value-basedpurchasing-programs.
48 https://www.macpac.gov/wp-content/uploads/
2024/01/Jan24_MedPAC_MACPAC_
DualsDataBook-508.pdf.
49 Beneficiaries Dually Eligible for Medicare and
Medicaid. Data from CY 2021. (January 2024).
Medpac and Macpac. https://www.macpac.gov/wpcontent/uploads/2024/01/Jan24_MedPAC_
MACPAC_DualsDataBook-508.pdf.
50 Access to Care Issues Among Qualified
Medicare Beneficiaries (QMB). (2015). Centers for
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benefit with their State’s Medicaid
program and must be redetermined
eligible at least annually.
There is growing recognition that
social risk factors—such as income,
education, access to food and housing,
and employment status—play a major
role in health,51 such that social risk
factors may affect a person’s ability to
reach their health goals, as well as the
diagnosis and treatment of their medical
problems. A report submitted to
Congress by the Office of the Assistant
Secretary for Planning and Evaluation
(ASPE) in response to the Improving
Medicare Post-Acute Care
Transformation (IMPACT) Act of 2014
(Pub. L. 113–185) found that dual
Medicare-Medicaid enrollment as a
marker for low income was typically the
most powerful predictor of poor
outcomes on quality measures among
social risk factors examined.52
Beneficiaries with social risk factors
may have worse health outcomes due to
a host of factors, including higher levels
of medical risk, worse living
environments (for example, availability
of community services, pollution,
safety), greater challenges in adherence
to medication regimens and medical
recommendations (for example, diet/
lifestyle), and/or bias or discrimination.
Evidence suggests that many health
outcomes are related more to social,
environmental, and economic factors
(which may be beyond practitioners’
control) than to clinical interventions.53
Dual enrollees, and more specifically,
QMBs, are therefore a category of
Medicare beneficiaries who we believe
to be the most socially at-risk of poorer
clinical outcomes. As stated in the
ASPE report, ‘‘Some of the observed
relationship between social risk factors
and outcomes may be the result of
underlying differences in medical
Medicare & Medicaid Services. https://
www.cms.gov/Medicare-Medicaid-Coordination/
Medicare-and-Medicaid-Coordination/MedicareMedicaid-Coordination-Office/Downloads/Access_
to_Care_Issues_Among_Qualified_Medicare_
Beneficiaries.pdf.
51 Long P, Abrams M, Milstein A, Anderson G,
Apton KL, Dahlberg M, Whicher D. Effective care
for high-need patients. Washington, DC: National
Academy of Medicine. 2017. https://nam.edu/wpcontent/uploads/2017/06/Effective-Care-for-HighNeed-Patients.pdf; Schroeder, S. (2007, September
20). We Can Do Better—Improving the Health of the
American People. New England Journal of
Medicine, 357(12), 1221–1228. https://
www.nejm.org/doi/full/10.1056/NEJMsa073350.
52 ASPE. Report to Congress: Social Risk Factors
and Performance Under Medicare’s Value-Based
Purchasing Programs. December 2016. https://
aspe.hhs.gov/reports/report-congress-social-riskfactors-performance-under-medicares-value-basedpurchasing-programs.
53 World Health Organization. (2018). Health
Impact Assessment (HIA): The determinants of
health. https://www.who.int/hia/evidence/doh/en/.
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complexity, frailty, disability, and/or
functional status. For example, duallyenrolled beneficiaries are more likely to
have poor functional status, and
therefore, may be more likely to be
readmitted after a hospitalization.’’ As
another example, a patient with
diabetes, heart failure, and QMB status
may experience food, transportation, or
housing insecurity that contributes to
difficulty maintaining blood glucose
control which can contribute to medical
complications including potentially
preventable heart failure exacerbations.
The primary care practitioner’s team
may need to check-in regularly to
ensure, for example, that the patient gets
needed specialty care such as an
ophthalmologic examination to avoid
the ocular manifestations of diabetes;
and consider the availability of
transportation vouchers so the patient
can attend the ophthalmology
appointment. We are proposing the
Level 3 APCM code to recognize the
unique characteristics of QMBs as
beneficiaries with social risk factors for
whom significantly more resources are
involved in comprehensive care
management by practitioners that
furnish advanced primary care services
to them.
Additionally, we note that patients
with QMB status are not responsible for
the Medicare cost-sharing associated
with covered Medicare Part A or B
services, including for any APCM
services. Generally, States cover such
cost-sharing on behalf of QMBs,
although many states use a ‘‘lesser-of’’
policy through which states pay less
than the full cost sharing amounts.54 We
solicit comments from States on how
they would cover cost sharing for the
proposed APCM bundle, considering
lesser-of policies.
We are also seeking feedback on the
use of QMB status and multiple (two or
more) chronic conditions as the basis to
bill for APCM Level 3 (GPCM3),
whether QMB status is an appropriate
indicator to identify beneficiaries with
added social risk, and whether there is
an equivalent marker of social
deprivation for use in commercial
markets that might be a possible
alternative identifier.
54 Under the ‘‘lesser of’’ policy, a State caps its
payment of Medicare cost-sharing at the Medicaid
rate for a particular service. For example, if the
Medicare rate for a service is $100, of which $20
is beneficiary coinsurance, and the Medicaid rate
for the service is $90, the state would only pay $10.
If the Medicaid rate is $80 or lower, the state would
make no payment.
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c. APCM Service Elements and PracticeLevel Capabilities
All the elements within the scope of
APCM services are included in the
service descriptors for GPCM1, GPCM2,
and GPCM3, listed in Table 22, and
described in this section. As described
above, we are proposing that APCM
services would include nearly the same
scope of service elements and
conditions we established for CCM and
PCM services (including elements of 24/
7 access and care continuity, care
management and care plan, care
coordination, management of care
transitions, and enhanced
communication). We believe this is
appropriate because care management is
a key component of care delivery using
an advanced primary care model. The
proposed phrasing in the code
descriptors for APCM services generally
tracks the code descriptors for CCM and
PCM services, except for references to
‘‘time spent’’ or ‘‘minutes’’ of service.
We are seeking to ensure that the
APCM codes would fully and
appropriately capture the care
management and CTBS services that are
characteristic of the changes in medical
practice toward advanced primary care,
as demonstrated in select CMS
Innovation Center models. As we do for
CCM and PCM services, we propose to
require for APCM services that the
practitioner provide an initiating visit
and obtain beneficiary consent (see
section II.G.2.c.(1) and II.G.2.c.(2) of this
proposed rule). As described in more
detail below, we are proposing to
incorporate as elements of APCM
services ‘‘Management of Care
Transitions’’ and ‘‘Enhanced
Communications Opportunities.’’ For
the ‘‘Management of Care Transitions’’
APCM service element, we are
proposing to specify timely follow-up
during care transitions (see section
II.G.2.c.(6) of this proposed rule). For
the ‘‘Enhanced Communications
Opportunities’’ APCM service element,
we are proposing to incorporate access
to CTBS services, including remote
evaluation of pre-recorded patient
information and interprofessional
telephone/internet/EHR referral
service(s), to maintain ongoing
communication with the patient, as well
as access to patient-initiated digital
communications that require a clinical
decision, such as virtual check-ins and
digital online assessment and
management and E/M visits (or e-visits)
(see section II.G.2.c.(8) of this proposed
rule).
We are also proposing to specify for
APCM services the practice-level
characteristics and capabilities that are
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inherent to, and necessarily present
when a practitioner is providing
covered services using an advanced
primary care delivery model. As
described in more detail below,
included in the service descriptors for
GPCM1, GPCM2, and GPCM3, and
listed in Table 22, our proposed
practice-level capabilities that reflect
care delivery using an advanced
primary care model are focused around
24/7 access and continuity of care (see
section II.G.2.c.(3) of this proposed
rule), patient population-level
management (see section II.G.2.c.(9) of
this proposed rule), and performance
measurement (see section II.G.2.c.(10) of
this proposed rule). These practice
capabilities are indicative of, and
necessary to, care delivery using an
advanced primary care model. Further,
APCM services, as we propose to define
them, could not be fully performed in
the absence of these practice
capabilities; and, in such cases, APCM
services should not be billed.
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We are proposing that practitioners
participating in the ACO REACH model,
the Making Care Primary model, and the
Primary Care First model would satisfy
the proposed initiating visit, patient
population-level management, and
performance measurement APCM
service elements and practice-level
capabilities by virtue of their model
participation. These CMS Innovation
Center models promote advanced
primary care delivery consistent with
the proposed APCM service elements
and practice-level capabilities described
in Table 21. The models all utilize
attribution methods that review the
most recently available two years of
Medicare claims to identify whether a
model participant is responsible for a
Medicare beneficiary’s primary care,
aligning with the initiating visit
requirements for APCM services.
Additionally, these three models also
include risk stratification and quality
and cost performance metrics that are
aligned or overlap with the Value in
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Primary Care MVP.55 Around-the-clock
access and continuity of care, patient
population-level management, and
performance measurement are
indicative of, and necessary to, care
delivery using an advanced primary
care model. We are also considering
whether certain practitioners in other
types of CMS Innovation Center models
also satisfy the proposed service
elements and requirements and seek
comments on this question.
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55 See, e.g., ACO Realizing Equity, Access, and
Community Health (REACH) Model Request for
Applications. Available at https://www.cms.gov/
priorities/innovation/media/document/aco-reachrfa, ACO Realizing Equity, Access, and Community
Health (REACH) Model PY 2024 Quality
Measurement Methodology. Available at https://
www.cms.gov/files/document/aco-reach-qualitymsr-meth-py24.pdf; Making Care Primary Payment
and Attribution Methodologies. Available at https://
www.cms.gov/files/document/mcp-pymt-attmethodologies.pdf, Primary Care First Payment and
Attribution Methodologies PY 2024. Available at
https://www.cms.gov/files/document/pcf-py24payment-meth.pdf.
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TABLE 21: APCM Service Elements* and Practice-Level Capabilities
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Consent
• Inform the patient of the availability of APCM services; that only one practitioner can furnish and be paid for
these services during a calendar month; of the right to stop services at any time (effective at the end of the calendar
month); and that cost sharing may apply* (may be covered by supplemental health coverage)
• Document in patient's medical record that consent was obtained
Initiating Visit for New Patients (separately paid)
• Initiation during a qualifying visit for new patients
• An initiating visit is not needed: (1) if the beneficiary is not a new patient (has been seen by the practitioner or
another practitioner in the same practice within the past three years) or (2) if the beneficiary received another care
management service (APCM, CCM, or PCM) within the previous year with the practitioner or another practitioner in
the same practice.
24/7 Access to Care and Care Continuity
• Provide 24/7 access for urgent needs to care team/practitioner with real-time access to patient's medical
information, including providing patients/caregivers with a way to contact health care professionals in the practice to
discuss urgent needs regardless of the time of day or day of week
• Continuity of care with a designated member of the care team with whom the patient is able to schedule
successive routine appointments
• Deliver care in alternative ways to traditional office visits to best meet the patient's needs, such as home visits
and/or expanded hours, as annropriate
Comprehensive Care Management
• Overall comprehensive care management may include, as applicable
• Systematic needs assessment (medical and psychosocial)
• System-based approaches to ensure receipt of preventive services
• Medication reconciliation, management and oversight of self-management
Patient-Centered Comprehensive Care Plan
• Development, implementation, revision, and maintenance of an electronic patient-centered comprehensive care
plan which is available timely within and outside the billing practice as appropriate to individuals involved in the
beneficiary's care, can be routinely accessed and updated by care team/practitioner, and copy of care plan to
patient/caregiver
Management of Care Transitions (for example, discharges, ED visit fo11ow-up, referrals, as applicable)
• Coordination of care transitions between and among health care providers 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, as applicable
• Ensure timely exchange of electronic health information with other practitioners and providers to support
continuity of care.
• Ensure timely fo11ow-up communication (direct contact, telephone, electronic) with the patient and/or
caregiver after ED visits and discharges from hospitals, skilled nursing facilities, or other health care facilities, within
7 calendar days of discharge, as clinica11y indicated
Practitioner, Home-, and Community-Based Care Coordination
• Ongoing communication and coordinating receipt of needed services from practitioners, home- and communitybased service providers, community-based social service providers, hospitals, and skilled nursing facilities (or other
health care facilities), as applicable, and document communication regarding the patient's psychosocial strengths and
needs, functional deficits, goals, preferences, and desired outcomes, including cultural and linguistic factors in the
patient's medical record
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Enhanced Communication Opportunities
• Enhanced opportunities for the beneficiary and any caregiver to communicate with the care team/practitioner
regarding the beneficiary's care through the use of asynchronous non-face-to-face consultation methods other than
telephone, such as secure messaging, email, internet, or patient portal, and other communication technology-based
services, including remote evaluation of pre-recorded patient information and interprofessional
telephone/internet/EHR referral service(s), to maintain ongoing communication with patients, as appropriate
• Ensure access to patient-initiated digital communications that require a clinical decision, such as virtual check-ins
and digital online assessment and management and E/M visits (ore-visits)
Patient Population-Level Management
• Analyze patient population data to identify gaps in care and offer additional interventions, as appropriate
• Risk stratify the practice population based on defined diagnoses, claims, or other electronic data to identify and
target services to patients
• A practitioners who is participating in a Shared Savings Program ACO, REACH ACO, Making Care Primary, or
Primarv Care First satisfies this requirement
Performance Measurement
Be assessed on primary care quality, total cost of care, and meaningful use of CEHRT, which can be met in several
ways:
• For MIPS-eligible clinicians, by registering for and reporting the Value in Primary Care MVP**
• A practitioner who is part of a TIN participating in a Shared Savings Program ACO satisfies this requirement
through the ACO's reporting of the APM Performance Pathway
• A practitioner who is participating in a Shared Savings Program ACO, REACH ACO, Making Care Primary, or
Primary Care First satisfies this requirement through the quality reporting, assessment and performance requirement
and other program and model requirements.
* Medicare beneficiaries who are enrolled in the QMB eligibility group do not have any Medicare cost-sharing
responsibility for copays, deductibles, and coinsurance.
** See discussion in section 11.G.2.c.(10) of this proposed rule for a description of the timeline of MIPS reporting.
For APCM services billed in 2025, practitioners would register to report the MVP in 2025, and report the MVP in
2026 for the 2025 performance year/2027 MIPS payment year. For more details, see the 2024 MIPS Quick Start
Guide, available at https:Ilqpp. cms.govlmipslreporting-options-overview.
We are seeking comment on whether
the proposed elements and
requirements are appropriately
reflective of care management services
for advanced primary care, and whether
there are proposed elements of APCM
services or proposed practice
capabilities that should be modified or
removed. We are also seeking feedback
on ways to align the APCM services
with other Medicare programs and
initiatives, such as the Shared Savings
Program, ACO REACH, and advanced
primary care models, and the Quality
Payment Program, including MIPS and
Advanced Alternative Payment Models
(Advanced APMs). We seek to create a
low burden way for practitioners to
furnish APCM services by appropriately
recognizing ways in which they may
meet APCM billing requirements as part
of these programs and initiatives. We
note that under the Quality Payment
Program, practitioners who are MIPS
eligible clinicians would report
measures and activities as specified by
CMS under the four MIPS performance
categories: quality, cost, improvement
activities, and Promoting
Interoperability (PI). To report to MIPS
for a performance period (§ 414.1320(i))
for the PI performance category, a MIPS
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eligible clinician must use Certified
EHR Technology (CEHRT), as defined at
paragraph (2) under CEHRT at
§ 414.1305, report on the objectives and
associated measures as specified by
CMS, and submit required attestations
as specified in § 414.1375(b)(3)
(§ 414.1375(b)). Eligible clinicians who
participate in Advanced APMs under
the Quality Payment Program are
required under the terms of those APMs
to use CEHRT as specified in
§ 414.1415(a)(1)(iii); and are paid under
the terms of those APMs based on MIPScomparable quality measures as
specified in § 414.1415(b).
As described in the sections below,
we are proposing that a billing
practitioner who is part of a Shared
Saving Program ACO, or CMS
Innovation Center ACO or participating
in Making Care Primary or Primary Care
First would already satisfy the proposed
practice-level requirements for patient
population-level management (see
section II.G.2.c.(9) of this proposed
rule), and performance measurement
(see section II.G.2.c.(10) of this proposed
rule) by meeting separately applicable
participation requirements within the
Shared Savings Programs and models.
As noted previously, we are considering
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whether practitioners in other types of
CMS Innovation Center models also
satisfy certain proposed service
elements and practice-level
requirements through their participation
in the models, and seek comments on
this question.
(1) Beneficiary Consent
Consistent with other care
management services, we are proposing
that the beneficiary’s consent to receive
APCM services must be documented in
the medical record as a condition of
payment for APCM services, as not all
Medicare beneficiaries for whom APCM
services would be medically necessary
may want to receive these services. As
we do for CCM and PCM services, we
are proposing to require billing
practitioners to inform the beneficiary of
the availability of APCM services, and
ensure the beneficiary is aware that
Medicare cost-sharing usually applies
(though these costs may be covered
through supplemental health coverage).
The practitioner should also inform the
beneficiary that, by providing APCM
services, they intend to assume
responsibility for all of the patient’s
primary care services and serve as the
continuing focal point for all needed
health care services; and that only one
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practitioner can furnish and be paid for
APCM services during a calendar
month, but that their consent to receive
APCM services does not limit their
option to receive Medicare covered
health care services from other
practitioners. The practitioner should
inform the beneficiary that APCM is an
ongoing, monthly service and of their
right to stop APCM services at any time
(effective at the end of the calendar
month), and that they only need to
provide consent once to receive APCM
services from the practitioner. We are
proposing that the practitioner would
document in the beneficiary’s medical
record that this information was
explained and note whether the
beneficiary accepted or declined APCM
services. We note that practitioners can
still elect to obtain written consent
rather than verbal consent.
Practitioners have informed us that
beneficiary cost sharing is a significant
barrier to provision of similar care
management services, such as CCM
services. The proposed patient consent
requirement is intended to ensure that
patients do not incur unexpected
expenses for care that is largely, or in
significant part, non-face-to-face in
nature. The proposed requirement for
patient consent would also help to
avoid duplicative practitioner billing, as
the patient would understand that the
practitioner intends to serve as the focal
point for all their care, and that only one
practitioner can furnish and be paid for
APCM services in any particular month.
We seek feedback on these proposed
requirements, including how best to
effectively educate both practitioners
and beneficiaries on the benefits of
APCM, especially as it reflects a new
bundle of services that may have
previously been separately billed, and
whether a CMS-provided template to
facilitate patient consent would be
helpful. We also seek feedback on
whether CMS should require
practitioners to revisit consent for
APCM services on an ongoing basis with
patients.
(2) Initiating Visit
Consistent with CCM services (CPT
codes 99437, 99439, 99487, and 99489–
99491) and PCM services (CPT codes
99424–99427), we are proposing to
require an initiating visit for APCM
services only for new patients instead of
for all beneficiaries receiving APCM
services. Consistent with the definition
of ‘‘new patient’’ as described in the
CPT® 2024 Professional Edition Code
Book on page 4, we are proposing to
define a ‘‘new patient’’ as a person who
did not receive any professional services
from the physician or other qualified
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health care professional or another
practitioner in the same group practice
within the previous 3 years.56 The
initiating visit furnished in advance of
APCM services establishes the
beneficiary’s relationship with the
billing practitioner, ensures the billing
practitioner assesses the beneficiary
prior to initiating APCM services,
facilitates collection of comprehensive
health information to inform the care
plan, and provides an opportunity to
obtain beneficiary consent (although
beneficiary consent can be obtained
outside of the initiating visit). We are
proposing that the same services that
can serve as the initiating visit for CCM
services could serve as the initiating
visit for APCM, including a Level 2
through 5 E/M visit, initial preventive
physician exam (IPPE), or TCM service,
and we propose that the initiating visit
could be provided in person or as a
Medicare telehealth service.
We are proposing that an initiating
visit would not be required for
‘‘established patients’’ based on certain
circumstances that we believe
demonstrate an established patientpractitioner relationship in advance of
furnishing APCM services: (1) if the
beneficiary is not a new patient (has
been seen by the practitioner or another
practitioner in the same practice within
the past three years) or (2) if the
beneficiary received another care
management service (including an
APCM service, non-complex or complex
CCM service (CPT codes 99487, 99489,
99490, 99491, 99439, 99437), or PCM
service (CPT codes 99424, 99425, 99426,
99427)) within the previous year with
the practitioner or another practitioner
in the same practice. We do not believe
there necessarily is a need for an
initiating visit for APCM services for
patients with whom the practitioner (or
another in the same practice) has an
established relationship; and we would
not want to require an initiating visit
under circumstances where a visit may
not be medically necessary. The
proposed policy not to require an
initiating visit for beneficiaries who
have received any professional service
from the physician or other qualified
health care professional or another
practitioner in the same group practice
within the previous 3 years is consistent
with CPT’s definition of the term
‘‘established patient,’’ such that we
believe this captures patients who have
been seen relatively recently and who
have an existing relationship with the
practice. In the case of beneficiaries who
56 American Medical Association. CPT
Professional 2024. American Medical Association,
2023.
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61711
have received care management services
from a practitioner within the practice
in the past year, we believe this
indicates that the patient is also an
‘‘established patient’’ in that the patient
has an existing relationship with the
practice, and the patient previously has
consented to the receipt of care
management services, which have
overlapping service elements with
APCM services.
We note that these standards would
be consistent with applicable Shared
Savings Program and CMS Innovation
Center patient attribution standards in
ACO REACH, Making Care Primary, and
Primary Care First. Any beneficiary
eligible to be assigned to an ACO
because of an established care
relationship between the beneficiary
and a billing practitioner who would be
billing for APCM services under the
ACO participant’s TIN, including
beneficiaries who voluntarily aligned to
a practitioner in the ACO, would not be
considered a new patient and would not
require an initiating visit. Medicare
rules governing patient attribution to an
ACO on the basis of care provided by an
ACO-participating clinician similarly
establishes where an existing care
relationship exists. Similarly,
beneficiaries eligible to be assigned to a
REACH ACO, or a Making Care Primary
or Primary Care First practice because of
an established care relationship between
the beneficiary and a billing practitioner
who would be billing for APCM services
under the model participant’s TIN,
including beneficiaries who voluntarily
aligned to a practitioner participating in
one of these three models would not be
considered a new patient and would not
require an initiating visit. While we are
proposing certain exceptions to the
initiating visit requirement for APCM
services, we note that an initiating visit
may still be needed even when not
required, and the billing practitioner
can always furnish and bill for
medically necessary visits, including
before initiating APCM services.
We seek feedback on these proposed
requirements, including whether
additional services could serve as the
initiating visit and whether a different
period of time (for example, patients not
seen within one or two years) would be
more appropriate.
(3) 24/7 Access and Continuity of Care
Access and continuity build on the
patient-practitioner relationship to
ensure patients receive the right care at
the right time from the right care team
member. We are proposing to include
for APCM services the same scope of
service elements we established for
CCM and PCM services for 24/7 Access
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and Continuity of Care with some
modifications. For 24/7 Access to Care,
the scope of the service element we
propose for APCM services would be to
provide 24/7 access for urgent needs to
the care team/practitioner with real-time
access to patient’s medical records,
including providing patients/caregivers
with a way to contact health care
professionals in the practice to discuss
urgent needs regardless of the time of
day or day of week.
As described in the CY 2017 PFS final
rule, this accurately reflects the
potential role of clinical staff or callsharing services in addressing afterhours care needs, and that after-hours
services typically would and should
address any urgent needs and not only
those explicitly related to the
beneficiary’s chronic conditions (79 FR
67722). In advanced primary care
models of care, primary care practices
should be at the center of that care—
providing an effective ‘‘first contact’’ for
patients, supporting patients in their
management of care, and coordinating
across different settings of care.
Achieving this level of access to primary
care requires timeliness and an effective
relationship with those in the practice
who are providing that care. True access
is fully informed by knowledge about
the patient and their care, which is only
possible through real-time access to the
patient’s electronic health information.
Access to primary care, informed by
health information technology (IT),
makes the right care at the right time
possible, potentially avoiding costly
urgent and emergent care. Practices can
achieve 24/7 access to care informed by
health IT through call coverage by a
practitioner with health IT system
access. This can be a practitioner from
the practice or a covering practitioner
who has system access. Many practices
and systems use nurse call lines or
answering services working with
standard protocols to provide the initial
point of contact after hours and
effectively address common problems.
In this situation, an escalation protocol
will engage a practitioner with system
access when needed for decision
making. Other successful practices
expand hours, add urgent care services
or partner with other practices to
provide these services, or contract with
existing urgent care providers to manage
and coordinate care after regular office
hours.
For Continuity of Care, the scope of
service element would be to provide
continuity of care with a designated
member of the care team with whom the
patient is able to schedule successive
routine appointments. Continuity of
care refers to the ability of patients to
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receive care from practitioners who
know them and are known by them.
This continuity builds and reinforces a
relationship based in trust and shared
experience that is highly valued by both
practitioners and patients. Practice
focus on continuity of care can translate
to improved preventive and chronic
care, patient and practitioner
satisfaction, lower hospital utilization,
and lower costs.57 Depending on the
type and setting of care, there are three
components of continuity that improve
patient outcomes and experience: 58
relational continuity (defined as the
‘‘ongoing therapeutic relationship
between a patient (and often their
family/caregiver)’’ which is
foundational in advanced primary care),
informational continuity (where
practitioners have access to information
on patients’ past events and personal
circumstances to inform current care
decisions); and longitudinal continuity
(which refers to ongoing patterns of
healthcare visits that occur with the
same practice over time). A key strategy
to optimize continuity is ensuring that
all practitioners and/or the care team
have access to the same patient
information to guide care within health
IT, and successful practices start with a
review and discussion of the practicelevel data developed through
measurement of continuity.59 Practices
57 Hussey, P.S., Schneider, E.C., Rudin, R.S., Fox,
D.S., Lai, J., & Pollack, C.E. (2014). Continuity and
the costs of care for chronic disease. JAMA Internal
Medicine, 174(5), 742–748; Bayliss, E.A., Ellis, J.L.,
Shoup, J.A., Zeng, C., McQuillan, D.B., & Steiner,
J.F. (2015). Effect of continuity of care on hospital
utilization for seniors with multiple medical
conditions in an integrated health care system. The
Annals of Family Medicine, 13(2), 123–129;
Nyweide, D.J., Anthony, D.L., Bynum, J.P.,
Strawderman, R.L., Weeks, W.B., Casalino, L.P., &
Fisher E.S. (2013). Continuity of care and the risk
of preventable hospitalization in older adults.
JAMA Internal Medicine, 173(20), 1879–1885;
Haggerty, J.L., Reid, R.J., Freeman, G.K., Starfield,
B.H., & Adair, C.E. (2003). Continuity of care: a
multidisciplinary review. BMJ, 327, 1219.
doi:10.1136/bmj.327.7425.1219; Gupta, R., &
Bodenheimer, T. (2013). How primary care
practices can improve continuity of care. JAMA
Internal Medicine, 173(20), 1885–1886.
doi:10.1001/jamainternmed.2013.7341; Willard R.,
& Bodenheimer T. (2012, April). The building
blocks of high-performing primary care: Lessons
from the field. California Healthcare Foundation.
https://www.chcf.org/publications/2012/04/buildingblocks-primary-care.
58 Haggerty, J.L., Reid, R.J., Freeman, G.K.,
Starfield, B.H., & Adair, C.E. (2003). Continuity of
care: a multidisciplinary review. BMJ, 327, 1219.
doi:10.1136/bmj.327.7425.1219.
59 Gupta, R., & Bodenheimer, T. (2013). How
primary care practices can improve continuity of
care. JAMA Internal Medicine, 173(20), 1885–1886.
doi:10.1001/jamainternmed.2013.7341; Willard R.,
& Bodenheimer T. (2012, April). The building
blocks of high-performing primary care: Lessons
from the field. California Healthcare Foundation.
https://www.chcf.org/publications/2012/04/buildingblocks-primary-care.
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can develop the capability to measure
continuity of care between the patient
and the practitioner/care team using
health IT, practice management
software, or other tracking mechanisms,
allowing them to track improvements
over time.
As included in the APCM code
descriptors, we are proposing to specify
for the ‘‘24/7 Access to Care’’ APCM
service element that the practice would
maintain the capability to deliver care
in alternative ways to traditional office
visits to best meet the patient
population’s needs, such as e-visits,
phone visits, home visits, and/or
expanded hours. This proposed
standard for alternatives to office visits
is similar to several requirements tested
in CMS Innovation Center models (such
as the CPC+ model’s requirement that
participating practices regularly offer at
least one alternative to traditional office
visits 60), and reflects the understanding
that providing alternatives to traditional
office visits is an essential element of
the delivery of care under an advanced
primary care model of care. Moving care
out of traditional office visits can reduce
demand and open supply for prioritized
visits. By changing where and how care
is delivered, practices may have
increased availability for patients with
complex needs who may be better
served by more time-intensive visits in
the office, at home, or in a nursing
home. We are not proposing that a
practice would need to regularly deliver
care in all these alternative ways—for
example, a practice may routinely offer
e-visits and phone visits, but not
regularly furnish home visits, and still
demonstrate this primary care practice
capability. Another practice might offer
extended hours on certain days to help
patients who may find it hard to take off
work to see their clinician, and this
would satisfy this practice requirement.
We seek feedback on these proposed
requirements.
(4) Comprehensive Care Management
We are proposing for APCM services
the ‘‘Comprehensive Care Management’’
service element we established for CCM
and PCM services with some
modifications. Rather than ‘‘care
management for chronic conditions,’’
the APCM service element would be
‘‘overall comprehensive care
management’’ which, like the element
for CCM and PCM services, may
include, as applicable, ‘‘systematic
assessment of the patient’s medical,
functional, and psychosocial needs;
60 https://www.cms.gov/priorities/innovation/
innovation-models/comprehensive-primary-careplus.
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system-based approaches to ensure
timely receipt of all recommended
preventive care services; medication
reconciliation with review of adherence
and potential interactions; and oversight
of patient self-management of
medications.’’ This care management
standard is similar to several
requirements tested in CMS Innovation
Center models (such as the CPC+
model’s requirement that participating
practices provide targeted, proactive,
relationship-based care management to
all patients identified as at increased
risk and likely to benefit from intensive
care management and provide shortterm care management, including
medication reconciliation, to patients
following hospital admission/discharge/
transfer, including observation stays,
and, as appropriate, following an ED
discharge) 61 and is an essential element
of the delivery of care under an
advanced primary care model of care.
Care management is a resourceintensive process of working with
patients, generally outside of face-toface office visits, to help them
understand and manage their health,
navigate the health system, and meet
their health goals. Practices working
with patients who have complex care
needs have found care management to
be an effective and necessary strategy
for mitigating risk and improving health
outcomes. Practices have found it
valuable to think in terms of two broad
types of patients who might benefit from
different approaches to care
management: patients with some
combination of multiple comorbidities,
complex treatment regimens, frailty and
functional impairment, behavioral and
social risks, and serious mental illness
who would often benefit from longterm, proactive, and relationship-based
longitudinal care management; and
patients who are otherwise stable and
will benefit from short-term, goaloriented episodic care management
during periods of increased risk like
transitions of care; diagnosis of a new,
serious illness or injury involving
complex treatment regimens; or newly
unstable chronic illness.
Successful practices use on-site, nonphysician, practice-based, or integrated
shared care managers to provide
longitudinal care management for the
highest risk cohort of patients, with
assistance from other practice staff, as
needed. Multiple team members may
engage in care management, but each
patient identified as eligible should
have a clinically trained individual in
61 https://www.cms.gov/priorities/innovation/
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the practice who is accountable for
active, ongoing care management that
goes beyond office-based clinical
diagnosis and treatment.62 Longitudinal
care management is captured in health
IT and includes providing proactive
care that moves beyond traditional
office visits or crisis-driven care (for
example, ED care or hospitalization) and
is not primarily visit-based. Although
office visits are opportunities to define
goals, plan patient care, engage in
shared decision making, and build a
trusting relationship, most care
management activities take place by
phone, patient portal, email, mail, or
home visits (and through visits to
skilled nursing facilities or hospitals to
support transitional care).
Practices use the concept of episodic
care management to identify patients
who have acute or urgent needs using
‘‘triggering events’’ (for example,
hospital discharge, new diagnoses,
medical crisis, major life event,
decompensation in otherwise controlled
chronic condition) for short-term,
problem-focused care management
services. Episodic care management is
generally time-limited and problem
focused and most often includes
coordination of services and follow-up,
patient education and support for selfmanagement, and medication
reconciliation.
We seek feedback on these proposed
requirements.
(5) Patient-Centered Comprehensive
Care Plan
We are proposing for APCM services
the ‘‘Comprehensive Electronic Care
Plan’’ service element we established for
CCM and PCM services with some
modifications. As included in the
APCM code descriptors, we are
proposing to specify that the care plan
is ‘‘patient-centered’’ which, as for CCM
and PCM services, ‘‘is available timely
within and outside the billing practice’’
as appropriate to individuals involved
in the beneficiary’s care, can be
routinely accessed and updated by care
team/practitioner, and ‘‘copy of care
plan to patient/caregiver.’’
Providing longitudinal care
management, which is an essential
element of the delivery of care under an
advanced primary care model of care,
includes the process of personalized
care planning. The personalized care
planning process helps practices engage
and collaborate with patients to ensure
62 Taylor, E.F., Machta, R.M., Meyers, D.S.,
Genevro, J., & Peikes, D.N. (2013). Enhancing the
primary care team to provide redesigned care: The
roles of practice facilitators and care managers.
Annals of Family Medicine, 11(1), 80–83.
doi:10.1370/afm.1462.
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that their care aligns with patient
preferences, goals, and values.63 A care
plan is a mutually agreed-upon
document that outlines the patient’s
health goals, needs, and selfmanagement activities and is accessible
to all team members providing care for
the patient. The care plan should be
patient-friendly, accessible to the
patient, and should limit use of
unfamiliar medical jargon and
acronyms. The care plan should also be
structured and standardized,
documented in health IT to enable
sharing among patient, caregivers, and
care team members. All high-risk
patients receiving longitudinal care
management should have a personalized
care plan developed in a joint, openended conversation between the patient
and care team. Personalized care
planning is a dynamic process;
therefore, the care plan document
should be updated at regularly defined
intervals by the care team and patient.
In addition, when patients’ health
status, preferences, goals, and values
change, their plans of care should, too.
As described in the CY 2020 final
rule, we proposed language to describe
the ‘‘typical’’ care plan elements which
do not comprise a set of strict
requirements that must be included in
a care plan for purpose of billing but are
intended to reflect those that are
typically included in a care plan as
medically appropriate for a particular
beneficiary. The comprehensive care
plan for all health issues typically
includes, but is not limited to, the
following elements: problem list;
expected outcome and prognosis;
measurable treatment goals; cognitive
and functional assessment; symptom
management; planned interventions;
medical management; environmental
evaluation; caregiver assessment;
interaction and coordination with
outside resources and practitioners and
providers; requirements for periodic
review; and when applicable, revision
of the care plan.
We seek feedback on these proposed
requirements.
(6) Management of Care Transitions
We are proposing to adopt for APCM
services the ‘‘Management of Care
Transitions’’ service element we
established for CCM and PCM services
with some modifications. Rather than
63 Coulter A., Entwistle, V.A., Eccles, A., Ryan, S.,
Shepperd, S., & Perera, R. (2015). Personalised care
planning for adults with chronic or long-term
health conditions. Cochrane Database System
Review, 3, CD010523; Edwards, S.T., Dorr, D.A., &
Landon, B.E. (2017). Can personalized care
planning improve primary care? JAMA, 318(1), 25–
26.
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requiring that the practice must
facilitate communication of relevant
patient information through electronic
exchange of continuity of care
documents with other health care
providers regarding these transitions,
we are proposing more simply to require
the billing practitioner to ‘‘ensure timely
exchange of electronic health
information’’ with other practitioners
and providers. As included in the
APCM code descriptors, we are also
proposing to specify for the
‘‘Management of Care Transitions’’
APCM service element that the care
team/practitioner would follow up with
the patient and/or caregiver within 7
days after each ED visit and hospital
discharge. This proposed timely followup standard is similar to several
requirements tested in CMS Innovation
Center models (such as the CPC+
model’s requirement that participating
practices ensure patients with ED visits
received a follow-up interaction within
one week of discharge 64 and the MCP
model’s requirement that participating
practices implement episodic care
management to provide timely followups for high-risk patients post ED visit
and hospitalization 65), and we
patterned the timely follow-up element
after our policy for TCM services which
requires, for example, ‘‘communication
(direct contact, telephone, electronic)
with the patient and/or caregiver with 2
business days of discharge’’ and a ‘‘faceto-face visit within 7 calendar days of
discharge.’’ Providing timely follow-ups
for patients is an essential element of
the delivery of care under an advanced
primary care model of care, and we
believe this will help achieve timely,
seamless care across settings especially
after discharge from a facility. Key
aspects of follow-up after ED visits and
hospitalizations include identifying and
partnering with target hospitals and EDs
where the majority of a practice’s
patients receive services to achieve
timely notification and transfer of
information following hospital
discharge and ED visits.66 When
64 https://www.cms.gov/priorities/innovation/
files/x/cpcplus-practicecaredlvreqs.pdf.
65 https://www.cms.gov/priorities/innovation/
innovation-models/making-care-primary.
66 Carrier, E., Yee, T., & Holzwart, R.A. (2011).
Coordination Between Emergency and Primary Care
Physicians (NIHCR Research Brief No. 3). National
Institute for Health Care Reform. https://nihcr.org/
analysis/improving-care-delivery/preventionimproving-health/ed-coordination/; Ventura, T.,
Brown, D., Archibald, T., et al. (2010, January–
February). Improving care transitions and reducing
hospital readmissions: establishing the evidence for
community-based implementation strategies
through the care transitions theme. https://
www.communitysolutions.com/assets/2012_
Institute_Presentations/caretransitioninterventions
051812.pdf.
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developing a standardized process for
data exchange and timely follow-up,
successful practices include the
following processes: information and
data exchange about patients seen in an
ED or admitted to/discharged from a
hospital (for example, via HIE, hospital
portal, hospital-generated report, EHR,
or additional health IT system);
definition for ‘‘timely’’ follow-up after
discharge (for example, no later than
within 2 days of discharge from hospital
admission or observation stay and
within 1 week of discharge from the
ED); protocols for when follow-up will
be done (for example, before discharge
or following a standardized follow-up
protocol); process of incorporating into
the patient’s medical record so the
information is available at the time of
the follow-up visit or other patient
contact; and standardized processes and
protocols for data exchange and
formalized partnerships to develop an
efficient workflow to ensure timely
follow-up and facilitate efficient and
safe transitions of care.
Practices use a variety of scheduling
strategies to prioritize same-day or nextday access for acutely ill patients and to
provide timely follow-up for patients
experiencing care transitions.
Successful practices are those that can
strike the right balance between timely
access to visits and the offering patients
a provider of their choice (Continuity of
Care). Establishing standardized
protocols and pathways to improve and
ensure responsiveness and timely
callbacks to patients is an effective way
to impact patient–practitioner/care team
communication and to ensure a
safeguard for addressing emergent and
urgent patient phone calls. Successful
practices routinely evaluate the degree
to which patients’ phone calls are
answered promptly or returned within a
practices’ established guidelines (for
example, non-urgent, emergent, urgent)
and routed to the appropriate
practitioner or care team member,
incorporating patients’ clinical needs
and preferences.67 Such strategies are
paramount for practices whose patients
may be contacting the practice with care
67 Hempel, S., Stockdale, S., Danz, M., Rose, D.E.,
Kirsh, S., Curtis, I., & Rubenstein, L.V. (2018).
Access management in primary care: Perspectives
from an expert panel (Research Report No. RR–
2536–DVA). Rand Corporation. https://
www.rand.org/content/dam/rand/pubs/research_
reports/RR2500/RR2536/RAND_RR2536.pdf;
O’Brien, L.K., Drobnick, P., Gehman, M.,
Hollenbeak, C., Iantosca, M.R., Luchs, S., Manning,
M., Palm, S.K., Potochny, J., Ritzman, A., TetroViozzi, J., Trauger, M., & Armstrong, A.D. (2017).
Improving responsiveness to patient phone calls: A
pilot study. Journal of Patient Experience, 4(3),
101–107. doi:10.1177/2374373517706611.
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needs that require care team
prioritization and urgent reply.
We seek feedback on these proposed
requirements.
(7) Practitioner, Home-, and
Community-Based Care Coordination
We are proposing to adopt for APCM
services the ‘‘Home- and CommunityBased Care Coordination’’ service
element we established for CCM and
PCM services with some modifications.
As included in the APCM code
descriptors, we are proposing to specify
that the ‘‘ongoing communication and
coordinating receipt of needed services’’
is with not only with home- and
community-based service providers, but
also with ‘‘practitioners,’’ ‘‘communitybased social service providers,
hospitals, and skilled nursing facilities
(or other health care facilities), as
applicable.’’ We are also proposing to
add more detail about the
communication documented in the
patient’s medical record in that it would
include ‘‘the patient’s psychosocial
strengths and needs, and functional
deficits, goals, preferences, and desired
outcomes, including cultural and
linguistic factors.’’
Coordinated referral management
with specialty groups and other
community or healthcare organizations
ensures referrals are properly managed,
coordinated, and communicated. These
efforts help practices achieve goals of
enhancing the quality of patient care,
improving the patient’s care experience,
and lowering cost, particularly for
practices serving high-risk patient
populations. Evidence suggests that the
development of formal relationships (for
example, collaborative care agreements)
between the primary care practice and
referred groups/organizations that
define shared goals and responsibilities,
facilitate the coordinated referral
management process.68 The foundation
of successful coordinated referral
management with specialty groups and
other community or healthcare
organizations is the development of
processes and procedures to ensure
high-value referrals, such as
collaborative care agreements and
electronic consultations (e-Consults).
Establishing clear and agreed-upon
expectations regarding communication
and clinical responsibilities with
specialty practices and other care
organizations, through a collaborative
care agreement, improves the process.
Collaborative care agreements often
68 Medicare Payment Advisory Commission
(MedPAC). (2012, June). Report to the Congress:
Medicare and the Health Care Delivery System.
https://medpac.gov/docs/default-source/reports/
jun18_medpacreporttocongress_sec.pdf?sfvrsn=0.
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include the following elements: defining
the types of referrals, consultation, and
co-management arrangements available;
specifying who is accountable for which
processes and outcomes for care within
the referral, consultation, or comanagement arrangement; and
specifying what clinical and other
information should be provided, how
the information is transferred, and
timeliness expectations. The electronic
e-Consults process is typically
conducted through a system-wide EHR
or a secure, web-based system by which
a practice receives guidance from a
specialty provider or other care
organization.69 In this process, a
practitioner sends a clinical question
and relevant clinical information to the
specialist (or other care organization),
who responds by providing a clinical
opinion and guidance and/or confirms
the need for a face-to-face appointment
with the patient. This tool and process
has the potential to streamline
consultations, reduce cost and burden
for patients, and improve access to
specialty care for high-value referrals.
As part of the CY 2019 PFS final rule,
we finalized interprofessional
consultation services codes, which
support payment both to the treating,
requesting (primary care) practitioner
(CPT code 99452) and the receiving,
consultative specialist (CPT codes
99446–99449 and 99451) who engage in
e-Consults, and so some practitioners
have already become accustomed to
providing and billing for these services.
Strategies for addressing common
health-related social needs (HRSNs) for
a practice’s high-risk patients include
conducting needs assessments at regular
intervals, creating a resource inventory
for the most pressing needs of the
patient population, and establishing
relationships with key community
organizations. Practices can focus on
developing relationships with
community-based organizations that
support patients’ most significant
HRSNs. Practices can also seek to find
common ground with community and
social service organizations, focus on
the structure and process of referrals,
and develop a bidirectional flow of
information. Successful practices work
with their patients to ensure there is a
shared understanding of the purpose of
the referral and aim to understand
bottlenecks and barriers to meeting their
needs through the process. Many
69 Vimalananda, V., Gupte, G., Seraj, S., Orlander,
J., Berlowitz, D., Fincke, B., & Simon, S. (2015,
September). Electronic consultations (e-consults) to
improve access to specialty care: A systematic
review and narrative synthesis. Journal of
Telemedicine and Telecare 21(6), 323–330. https://
www.ncbi.nlm.nih.gov/pmc/articles/PMC4561452/.
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practices identify a care team member to
be a community referral resource for
their patients. Successful referrals can
help practices determine the most
useful and available resources in their
community.
We seek feedback on these proposed
requirements.
(8) Enhanced Communications
Opportunities
We are proposing to include for
APCM services the element of
‘‘Enhanced Communications
Opportunities’’ we established for CCM
and PCM services with some
modifications. Specifically, we would
add ‘‘internet and patient portal’’ as
examples of asynchronous non-face-toface consultation methods and specify
that the practitioner would provide
‘‘other communication technologybased services, including remote
evaluation of pre-recorded patient
information and interprofessional
telephone/internet/EHR referral
service(s), to maintain ongoing
communication with patients, as
appropriate’’ as well as specify ‘‘access
to patient-initiated digital
communications that require a clinical
decision, such as virtual check-ins and
digital online assessment and
management and E/M visits (or evisits).’’ Providing asynchronous nonface-to-face consultation methods and
other CTBS services is an essential
element of the delivery of care under an
advanced primary care model of care,
and we believe this will allow patients
to access their usual source of care more
conveniently (see section II.G.2.c.(3) of
this proposed rule). There is growing
consensus that incorporating telehealth
into primary care will allow patients to
access their usual source of care more
conveniently.70 Patients using
telehealth visits have reported high
satisfaction, identifying convenience
and perceived high quality of care as
contributors,71 such that these may be a
good alternative and, in some cases,
preferable to in-person
communication.72 Expansion of
70 Levine DM, Linder JA. Retail Clinics Shine a
Harsh Light on the Failure of Primary Care Access.
J Gen Intern Med. 2016;31(3):260–262.; Dorsey ER,
Topol EJ. State of Telehealth. N Engl J Med.
2016;375(2): 154–161.; Powell, Rhea E., et al.
‘‘Patient perceptions of telehealth primary care
video visits.’’ The Annals of Family Medicine 15.3
(2017): 225–229.
71 Polinski JM, Barker T, Gagliano N, Sussman A,
Brennan TA, Shrank WH. Patients’ Satisfaction
with and Preference for Telehealth Visits. J Gen
Intern Med. 2016;31(3):269–275.
72 Krishnan N, Fagerlin A, Skolarus TA.
Rethinking Patient-Physician Communication of
Biopsy Results—The Waiting Game. JAMA Oncol.
2015;1(8):1025–1026.; Cusack CM, Pan E, Hook JM,
Vincent A, Kaelber DC, Middleton B. The value
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telehealth to address episodic and
chronic conditions has been a
significant trend in the evolution of
telehealth applications, and there is
some evidence that video visits may
enable more timely communication of
test results than in-person
appointments.
As noted in section II.G.2.b. of this
proposed rule, we are not proposing
timeframe restrictions for this proposed
element, which includes access to
certain CTBS (for example, the
restriction for virtual check-in services
that there is not a related E/M service
provided within the previous 7 days or
an E/M service or procedure within the
next 24 hours or the soonest available
appointment).
We seek feedback on these proposed
requirements.
(9) Patient Population-Level
Management
As specified in the proposed APCM
code descriptors, we are proposing to
establish an APCM service element for
Patient Population-Level Management
that would include practice capabilities
for population-based, data-driven
approaches to manage preventive and
chronic care for their patient population
and to plan and implement strategies to
improve care and outcomes. We are
proposing that all practices would use
data to develop clear improvement
strategies and analytic processes to
proactively manage population health,
including analyzing patient population
data to identify gaps in care and riskstratifying the practice population based
on defined diagnoses, claims, or other
electronic data to identify and target
services to patients (such as those at risk
for poor health outcomes), and then
would offer additional interventions, as
appropriate.
These proposed patient populationlevel management standards are similar
to several requirements tested in CMS
Innovation Center models, including
CPC+, which found that model
participants used data to identify and
resolve gaps in care. We have modeled
the proposed patient population-level
management standards on the CPC+
care delivery requirements. In the CPC+
Model, participating practices were
required, for example, to ‘‘use a twostep risk stratification process for all
empaneled patients, addressing medical
need, behavioral diagnoses, and healthrelated social needs’’ and ‘‘define at
least one subpopulation of patients with
specific complex needs, develop
capabilities necessary to better address
proposition in the widespread use of telehealth. J
Telemed Telecare. 2008;14(4):167–168.
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those needs, and measure and improve
the quality of care and utilization of this
subpopulation.’’ 73 Central to the
delivery of advanced primary care is the
organization of the practice into care
teams that have the data they need to
manage their patient populations and
that have time allocated to plan and
implement practice improvement
strategies.74 Using evidence-based
protocols, registries, and the registry
functionality of the EHR, reminders and
outreach help practices deliver
appropriate preventive care and
consistent evidence-based management
of chronic conditions for the entire
patient population.75 Measurement of
clinically relevant data at the practicelevel guides testing and implementing
strategies to improve care and outcomes.
Patient population-level management
capabilities are essential to the delivery
of care under an advanced primary care
model of care and enable practices to
meet the preventive and chronic care
needs of their entire patient population.
Regular use of data to identify
populations or groups of patients with
similar needs allows practices and care
teams to use streamlined strategies,
including setting goals with measurable
outcomes, to positively impact their
patient populations. Evidence shows
that primary care teams supported with
real-time, population-level clinical
outcomes data effectively manage
population health and address care gaps
which eliminates external costs to close
gaps in care.76 More specifically, risk
stratification allows practitioners to
identify beneficiaries for longitudinal
care management, track beneficiaries
with higher levels of need and manage
their conditions, and prevent
beneficiaries from falling through the
cracks, while developing strategies to
address those patients who are at
increased and rising risk and most likely
to benefit from targeted, proactive,
relationship-based care management
and other strategies essential to
APCM.77 Empanelment, which assigns
73 CPC+
Care Delivery Resource. January 2019.
Care Delivery Resource. January 2019.
75 O’Malley AS, Draper K, Gourevitch R, Cross
DA, Scholle SH. Electronic health records and
support for primary care teamwork. J Am Med
Inform Assoc. 2015 Mar;22(2):426–34. doi: 10.1093/
jamia/ocu029. Epub 2015 Jan 27. PMID: 25627278;
PMCID: PMC4394968.
76 https://www.cms.gov/priorities/innovation/
files/x/cpcplus-practicecaredlvreqs.pdf.
77 Hayes, S.L., & McCarthy, D. (2016, December
7). Care Management Plus: Strengthening Primary
Care for Patients with Multiple Chronic Conditions.
The Commonwealth Fund. https://
www.commonwealthfund.org/publications/casestudies/2016/dec/care-management-plus; Hong,
C.S., Siegel, A.L., & Ferris, T.G. (2014, August).
Caring for High-Need, High-Cost Patients: What
Makes for a Successful Care Management Program?
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74 CPC+
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each active patient to a practitioner and/
or care team with consideration of
patient and caregiver preferences,
allows practices to build responsive care
teams to optimize patient care and to
address the preventive, chronic, and
acute needs of all patients, and provides
a way for practices to identify care gaps
and proactively reach out to patients
who have not been seen or contacted in
a while.78 For example, we believe these
elements of advanced primary care
management could increase screening
rates and ultimately improve care of
chronic conditions, such as
hypertension and diabetes.
We note that this Patient PopulationLevel Management requirement of the
APCM services would be met for
practitioners billing for APCM services
through a TIN that is participating in an
ACO in the Shared Savings Program by
virtue of the practitioner’s participation
in the ACO which must meet eligibility
requirements for population
management, care coordination and
quality improvement, including
required processes and patientcenteredness criteria in § 425.112. We
note that ACOs in the Shared Savings
Program and their practitioners are
already engaged in analyzing the patient
population for care gaps, risk-stratifying
patients to further identify those at risk
for poor health outcomes, and
identifying patients for whom
additional interventions are appropriate.
Similarly, the ACO REACH, Making
Care Primary, and Primary Care First
CMS Innovation Center Models all
require their participants to deploy
population health strategies to identify
and offer interventions to mitigate
health risks.79 Participants in these
The Commonwealth Fund https://
www.commonwealthfund.org/∼/media/files/
publications/issue-brief/2014/aug/1764_hong_
caring_for_high_need_high_cost_patients_ccm_
ib.pdf; Lakin, J.R., Robinson, M.G., Obermeyer, Z.,
Powers, B.W., Block, S.D., Cunningham, R.,
Tumblin, J. M.m Vogeli, c., & Bernacki, R.E. (2019).
Prioritizing primary care patients for a
communication intervention using the ‘‘Surprise
Question’’: A prospective cohort study. Journal of
General Internal Medicine, 8.
78 Grumbach, K., & Olayiwola, N.J. (2015). Patient
empanelment: The importance of understanding
who is at home in the medical home. Journal of the
American Board of Family Medicine, 28(2), 170–
272.; Altschuler, J., Margolius, D., Bodenheimer, T.,
& Grumbach, K. (2012). Estimating a reasonable
patient panel size for primary care physicians with
team-based task delegation. Annals of Family
Medicine, 10(5), 396–400. doi:10.1370/afm.1400.
79 ACO Realizing Equity, Access, and Community
Health (REACH) Model Request for Applications.
Available a: https://www.cms.gov/priorities/
innovation/media/document/aco-reach-rfa, Making
Care Primary Request for Applications. Available at
https://www.cms.gov/files/document/mcp-rfa.pdf,
Primary Care First Request for Applications Cohort
2. Available at https://www.cms.gov/priorities/
innovation/media/document/pcf-cohort2-rfa.
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models and their practitioners are
already engaged in population health
management as described in Table 21.
We seek feedback on these proposed
requirements.
(10) Performance Measurement
We are proposing for the APCM
services a practice-level requirement of
performance measurement of primary
care quality, total cost of care, and
meaningful use of CEHRT. Performance
measurement is a critical element of
care management services delivered in
the context of advanced primary care,
and it forms the basis for practice
improvement efforts by enabling
practices to identify key measures for
improvement activities (for example,
cost and utilization data, clinical quality
measures, patient experience of care
data). Quality measurement improves
care delivery, including prevention of
heart attacks, increasing vaccination
rates, and improving patient safety,80
and quality measures are also effective
tools to ensure that high-quality
advanced primary care, including care
management, is being delivered. Several
performance measurement requirements
were tested in CMS Innovation Center
models (such as the CPC+ model’s
requirement that participating practices
use data at both the practice- and panellevel to set goals to improve population
health management and to continuously
improve patients’ health, experience,
and quality of care, and decrease cost).
Using data resources and developing
workflows and analytics to guide
practice changes can help practices
achieve reductions in total utilization
and cost of care, and improvements in
patient experience and quality of care.
Improving upon key outcome measures
requires engaged clinical and
administrative leadership and a
commitment to continuous, data-driven
improvement.81 In the context of the
PFS, performance management through
quality measurement as a practice-level
requirement also ensures integrity to the
provision of advanced primary care
because it holds billing practitioners
accountable to factors that are affected
by several service elements of APCM
coding. For example, effective patientpopulation level management can mean
the practices close care gaps in diabetes
management, and the billing
practitioner would perform better on
diabetes quality measures that assess for
a patient’s control of hemoglobin A1c.
80 https://www.ahrq.gov/patient-safety/qualitymeasures/21st-century/challenges.html.
81 https://www.cms.gov/priorities/innovation/
innovation-models/comprehensive-primary-careplus.
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We are proposing that this
performance measurement practicelevel requirement can be met in several
ways. For MIPS-eligible clinicians, the
requirement would be met by registering
for and reporting the ‘‘Value in Primary
Care’’ MIPS Value Pathway (MVP). A
practitioner who is part of a TIN that is
participating as a Shared Savings
Program ACO or a REACH ACO, or a
Primary Care First or Making Care
Primary practice would meet these
requirements by virtue of the Shared
Savings Program and CMS Innovation
Center quality reporting, assessment of
quality performance, accountability for
total cost of care, and other program and
model requirements.
In the CY 2024 PFS final rule (88 FR
80042 through 80047), we finalized
‘‘The Value in Primary Care’’ Meritbased Incentive Payment System (MIPS)
Value Pathway (MVP), which focuses on
the clinical theme of promoting quality
care for patients in order to reduce the
risk of diseases, disabilities, and death;
and it includes cost measures,
Promoting Interoperability (PI)
measures, improvement activities, and
quality measures for common chronic
conditions (for example, hypertension,
diabetes, depression).82 The Value in
Primary Care MVP contains the Adult
Universal Foundation quality measure
set, which is consistent with the
National Quality Strategy goal of using
the Universal Foundation measures
across as many programs as is feasible.83
This MVP is especially well-suited to
reflect the delivery of care using the
advanced primary care model as it was
developed to include quality metrics
that reflect clinical actions that should
be considered the foundations of
primary care. The quality measures
include key elements such as cancer
screening, immunization, blood
pressure management, behavioral
health, care coordination, personcentered care, and screening for social
drivers of health. The improvement
activities include engaging community
resources to address drivers of health,
implementing changes in the practice’s
patient portal to improve
communication and patient
engagement, reviewing practices in
place on targeted patient population
needs, and chronic care and preventive
care management for empaneled
patients, aspects of advanced primary
care already discussed in this proposal.
The cost measures include costs for
82 Value
in Primary Care. Quality Payment
Program. https://qpp.cms.gov/mips/explore-mipsvalue-pathways/2024/M0005.
83 https://www.cms.gov/medicare/quality/cmsnational-quality-strategy/aligning-quality-measuresacross-cms-universal-foundation.
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common chronic conditions, such as
asthma/chronic obstructive pulmonary
disease (COPD), diabetes, depression,
and heart failure, as well as the Total
Per Capita Cost (TPCC) measure, which
assesses the overall cost of care
delivered to a patient with a focus on
the primary care they receive from their
provider(s) and captures the broader
healthcare costs influenced by primary
care.84 The Value in Primary Care MVP
serves to demonstrate performance
measurement that is reflective of the
care furnished using advanced primary
care delivery. To ensure performance
measurement consistent with the
delivery of advanced primary care
services, we are proposing as an element
of the APCM services that a practitioner
who is a MIPS eligible clinician as
defined in § 414.1305 can satisfy the
performance measurement requirement
by registering for and reporting the
Value in Primary Care MVP for the
performance year in which they bill for
APCM services. A MIPS eligible
clinician can report to MIPS as an
individual, subgroup, group, APM
Entity, or in any combination of these
four participation options, and can
participate in multiple ways to report
MVPs.85
MIPS-eligible clinicians who report
the MVP are also required to report the
PI performance category measures and
attestations throughout the performance
period in which they bill for APCM
services,86 as required under
§ 414.1375(b) (§ 414.1365(c)(4)(i)) (see
section IV of this proposed rule for
details on reporting the objectives and
measures for the MIPS PI performance
category for CY 2025 performance
period/2027 MIPS payment year). The
measures in the MIPS PI performance
category include measures such as
electronic referral loops, receiving and
reconciling health information, and
providing patients with electronic
access to their health information, all of
which are reflective of important
communication and coordination
channels between primary care, other
specialist practitioners caring for the
patient, and the patient themselves. In
addition, as set forth in 42 CFR
414.1375(b)(3), the MIPS PI performance
category also requires submission of
affirmative attestations: (1) regarding
their cooperation in good faith with
ONC direct review of their CEHRT; and
84 https://qpp.cms.gov/docs/cost_specifications/
2023-12-13-mif-tpcc.pdf.
85 https://qpp.cms.gov/mips/mvps/learn-aboutmvp-reporting-option?option=Group.
86 The MIPS PI performance period is a minimum
of 180 consecutive days in the calendar year that
occurs 2 years prior to the MIPS payment year (see
42 CFR 414.1320(i)).
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(2) that they did not knowingly and
willfully take action (such as to disable
functionality) to limit or restrict the
compatibility or interoperability of
CEHRT.87
For CCM services (CPT codes 99437,
99439, 99487, and 99489–99491) and
PCM services (CPT codes 99424–99427),
we established that practitioners must
use CEHRT to record certain patient
health information in a structured
format, provide patients with access to
their health information, and exchange
all relevant patient health information,
including in providing the
‘‘Management of Care Transitions’’
element of CCM services. For the APCM
services, which are furnished as part of
a practitioner’s care delivery using the
advanced primary care model, we are
proposing for practitioners who are
MIPS eligible clinicians a practice-level
requirement to register for and report
the MVP, including but not limited to
the PI performance category measures
which focus on meaningful use of
CEHRT, ensuring that patients/
caregivers and physicians or other
qualified practitioners or clinical staff
have real-time access to patient’s
medical information. We believe that
comprehensive CEHRT use is a critical
element of care management services
delivered in the context of advanced
primary care.
As we stated in adopting the CEHRT
use element for CCM and PCM services,
we believe that the meaningful use of
CEHRT is vital to ensure that
practitioners are capable of providing
the full scope of services, such as timely
care coordination and continuity of care
(see our prior discussion of this issue at
79 FR 67723 and 84 FR 62696), and we
believe that flexibility in how practices
can provide the requisite 24/7 access to
care, continuity of care, and
management of care transitions, can
facilitate appropriate access to these
services for Medicare beneficiaries. The
meaningful use of CEHRT helps ensure
that members of the care team have
timely access to the patient’s most
updated health information and offer an
integrated view of a patient’s clinical
history from different points of care,
supporting continuing, quality, and
integrated healthcare while avoiding
duplication of efforts and costs, such as
87 Note that, under the Quality Payment Program,
CMS may reweight the MIPS PI performance
category to zero percent of the MIPS final score, and
not require an individual, group, or virtual group
to use CEHRT and demonstrate whether they are a
meaningful user of CEHRT, by granting a significant
hardship exception or other type of exception based
on certain circumstances as set forth in 42 CFR
414.1380(c)(2)(i)(C).
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lotter on DSK11XQN23PROD with PROPOSALS2
repeated exams.88 For example,
practices use EHRs to identify high-risk
patients with chronic conditions to
better coordinate care and can
supplement the practice’s EHR data
with data from external sources (for
example, State-level quality
organizations) to obtain a more
comprehensive view of patients.
Practices can also integrate clinical data
from EHRs, health plan claims data, and
county-level social services data to
evaluate population needs, stratify by
risk, and assess what programs would
be most effective for supporting at-risk
patients.89 Standardized
communication methods, enabled by
CEHRT, are a significant part of the
advanced primary care delivery model.
Health IT systems that include remote
access to the care plan or the full EHR
after hours, or a feedback loop that
communicates back to the primary care
physician and others involved in the
beneficiary’s care regarding after-hours
care or advice provided, are extremely
helpful.90 They help ensure that the
beneficiary receives necessary follow
up, particularly if the patient is referred
to the ED, and follow up after an ED
visit is required under the element of
‘‘Management of Care Transitions.’’
Accordingly, we believe the use of
CEHRT or remote access to the care plan
is fundamental to providing the APCM
service elements of 24/7 Access to Care,
Continuity of Care, and Management of
Care Transitions under an advanced
primary care delivery model. Requiring
performance of the requirements in
these measures and attestations to the
meaningful use of CEHRT is similar to
several requirements tested in CMS
Innovation Center models (such as the
PCF model’s requirement that
participating practices adopt and
maintain CEHRT for electronic clinical
quality measure reporting, support data
exchange with other providers and
health systems, and connect to their
regional health information exchange
(HIE),91 and the MCP model’s
requirement that participating practices
use EHR technology that has been
certified under the ONC Health IT
88 McDonald, C.J., Tang, P.C., Hripcsak, G. and In:
(eds) Biomedical Informatics. Springer, L. (2014),
‘‘Electronic Health Record Systems,’’ in Biomedical
Informatics, Shortliffe, E.H. and Cimino, J.J., eds.
London: Springer, pp. 391–421.
89 Harvey, Jillian B., et al. ‘‘Understanding how
health systems facilitate primary care redesign.’’
Health Services Research 55 (2020): 1144–1154.
90 https://www.ncbi.nlm.nih.gov/pmc/articles/
PMC3475839/#CR25.
91 https://www.cms.gov/priorities/innovation/
innovation-models/primary-care-first-modeloptions.
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Certification Program 92). Furthermore,
the Shared Savings Program requires
practitioners (that is, MIPS eligible
clinicians, QPs and Partial QPs) in all
ACOs to demonstrate meaningful
CEHRT use through the reporting of the
MIPS Promoting Interoperability
annually beginning in 2025.
We recognize that many practitioners
who are not MIPS eligible clinicians for
a year would be excluded from MIPS by
achieving Qualifying APM Participant
(QP) status based on their levels of
participation in an Advanced APM.
Based on the characteristics of
Advanced APMs detailed in § 414.1415,
including the requirement that payment
is based on MIPS or MIPS-comparable
quality measures, practitioners who
with QP status are necessarily engaging
in performance measurement through
the Advanced APMs in which they
participate in a way that is consistent
with advanced primary care. We also
recognize there are other practitioners
who are not MIPS eligible clinicians for
other reasons, such as practitioners who
are newly enrolled in Medicare or bill
a low volume of Medicare services.
These practitioners technically could
bill for APCM services. However, newly
enrolled practitioners are only excluded
from MIPS for one year, after which the
practitioner would either be a MIPS
eligible clinician who would need to
report the MVP in order to bill for
APCM services, or excluded from MIPS
on another basis such as QP status. In
the case of practitioners with low
Medicare volume, we anticipate that
they would be unlikely to bill for APCM
services since the delivery of advanced
primary care generally involves time
and resources to establish practice-level
infrastructure, and the economies of
scale usually make this a more likely
investment if the infrastructure can be
utilized across a larger patient panel.
We are also proposing that the
performance measurement element of
the APCM services would be satisfied
for practitioners billing for APCM
services through a TIN that is
participating in a Shared Savings
Program ACO for a performance year in
which they furnish APCM services.
ACOs are currently required to report
the APP quality measure set on behalf
of their practitioners, and would be
required to report the APP Plus quality
measure set as proposed in Section III.G.
of this proposed rule. Practitioners in
ACOs are also already being held
accountable for reporting and
performance and outcomes on many of
the Universal Foundation measures
92 https://www.cms.gov/priorities/innovation/
innovation-models/making-care-primary.
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already, which are used in the Value in
Primary Care MVP, and the APP Plus
quality measure set would fully align
the Shared Savings Program’s quality
performance standard with the
Universal Foundation measures upon
the complete implementation of the
APP Plus measure set.
We propose to include the
performance measurement requirement
as an element of APCM services
furnished by practitioners. MIPS eligible
clinicians who intend to report on the
Value in Primary Care MVP for the CY
2025 must register to report the Value in
Primary Care MVP as described under
§ 414.1365(b), a MIPS eligible clinician
must register for an MVP during
between April 1 and November 30 of the
applicable CY performance period to
report the MVP. MIPS eligible clinicians
submit data on measures and activities
in the first quarter of the year following
(CY 2026) the MIPS performance period.
Under this proposal, a MIPS eligible
clinician billing for APCM services
furnished in 2025 and who is satisfying
the performance measurement
requirement through reporting the Value
in Primary Care MVP, would need to
register for the MVP between April and
November of 2025 and report data
between January and March 2026 on
measures and activities in the Value in
Primary Care MVP relating to services
furnished in 2025. A MIPS eligible
clinician billing for APCM services
furnished in 2026 and who is satisfying
the performance measurement
requirement through reporting the Value
in Primary Care MVP, would need to
register for the Value in Primary Care
MVP between April and November of
2026, and report data between January
and March of 2027 on measures and
activities in the Value in Primary Care
MVP relating to services furnished in
2026, and so on in subsequent years.
As described above, we are seeking
feedback on ways to align the APCM
services with other Medicare programs
and initiatives, such as the Shared
Savings Program and the Quality
Payment Program, including MIPS and
Advanced APMs. We seek to create a
low burden way for practitioners to
furnish APCM services by appropriately
recognizing ways in which they may
meet APCM billing requirements as part
of these programs and initiatives,
including other ways that practitioners
may be fulfilling these performance
measurement requirements. We are
seeking feedback on whether there are
areas of duplication within the APCM
service elements and practice
capabilities that we should consider
addressing. We are also seeking
comment on how to appropriately align
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the time period for which the
practitioner bills the monthly APCM
code with the calendar year reporting
period covered by the MVP, and how
we would verify and enforce the
performance measurement requirement
of the APCM service.
We seek feedback on these proposed
requirements.
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d. Duplicative Services and Concurrent
Billing Restrictions
In this section, we identify the
services that would overlap
substantially with APCM services based
on the proposed elements of the scope
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of service for APCM which we have
built into the service descriptors for
GPCM1, GPCM2, and GPCM3 (see
sections II.G.2.b. and II.G.2.c. of this
proposed rule). As such, we are
proposing that APCM services could not
be billed by the same practitioner or
another practitioner within the same
practice for the same patient concurrent
with these other services: CCM, PCM,
TCM, interprofessional consultation,
remote evaluation of patient videos/
images, virtual check-in, and e-visits.
Given that we have intentionally
designed the proposed elements of
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APCM services to track closely with the
elements of several other care
management service and CTBS codes,
these services are substantially
duplicative of APCM services. Further,
these specific services (shown in Table
19) are duplicative with APCM services
because there is significant overlap in
the patient populations included in the
code descriptors for these services and
APCM services, such as patients who
have chronic conditions, high-risk
conditions, or both complex and
chronic conditions.
BILLING CODE P
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TABLE 22: Care Management and CTBS which CMS Proposes are Substantially
Du licative of APCM Services
Chronic Care
Management
(CCM)(CPT
Codes 99487,
99489, 99490,
99491, 99439,
9943
Management of all care for patients with two or more serious chronic conditions, timed, per
month
Transitional
Care
Management
(TCM)(CPT
Codes 99495,
99496
Management of transition from acute care or certain outpatient stays to a community setting,
with face-to-face visit (bundled into payment for the code), once per patient within 30 days
post-discharge
Interprofessional
Internet
Consultation
(IPC)(CPT
Codes 99446,
99447, 99448,
99449, 99451,
99452
Consultations between or among certain kinds of medical practitioners.
As we have described in the sections
above, comprehensive care management
services are essential to providing
advanced primary care in the context of
this proposal, and many of the service
elements for CCM/PCM/TCM shown in
Table 19 are substantially the same as
the elements we are proposing for
APCM services.
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Also described above, providing
CTBS is an essential element of the
delivery of care under an advanced
primary care model of care. Recognizing
this, we designed the proposed APCM
service elements to substantially overlap
with the elements of the CTBS (for
example, interprofessional consultation
and e-Visits) shown in Table 22. CTBS
are used in delivery of advanced
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primary care to maintain ongoing
communication with patients and
enable interprofessional care teams to
provide comprehensive support to
manage chronic conditions over time,
which we believe will allow patients to
access their usual source of care more
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conveniently.93 We also believe that
interprofessional consultation can help
promote integration of behavioral health
and primary care.94
We also considered whether other
care management services (such as
Behavioral Health Integration (BHI)),
services addressing HRSNs (Community
Health Integration (CHI), Social
Determinants of Health Risk
Assessment, and Principal Illness
Navigation (PIN)), and/or other CTBS
(Remote Physiologic Monitoring (RPM)
and Remote Therapeutic Monitoring
(RTM)) would be duplicative of the
proposed APCM services. We believe
that these services, when appropriate,
may complement APCM services rather
than substantially overlap or duplicate
services, and that these other services
are sufficiently different from the APCM
services in the nature and extent of the
interventions and the qualifications of
individuals providing the services, to
allow concurrent billing for services
when appropriate. While these may be
services that a practitioner using the
advanced primary care model would be
likely to furnish, when appropriate, they
are not part of the core, routinely and
universally essential elements of the
advanced primary care model. We also
believe that several of these other
services (such as BHI, CHI, SDOH Risk
Assessment, and PIN) could be
supplemental to APCM for patients that
have very specific identified health care
needs.
We are seeking more information from
interested parties through our Advanced
Primary Care RFI about whether to
consider incorporating additional
service elements into the APCM service
elements and valuation for APCM
codes; and whether and, if so, how to
best incorporate E/M services into
future coding (see section II.G.3. of this
proposed rule). We note that, for BHI
services, there is an established
evidence base for approaches to caring
for beneficiaries with behavioral health
conditions which involve integration in
the primary care setting, are typically
provided by a primary care team, and
include structured care management
with regular assessments of clinical
status and modification of treatment.
93 Levine DM, Linder JA. Retail Clinics Shine a
Harsh Light on the Failure of Primary Care Access.
J Gen Intern Med. 2016;31(3):260–262.; Dorsey ER,
Topol EJ. State of Telehealth. N Engl J Med.
2016;375(2):154–161.; Powell, Rhea E., et al.
‘‘Patient perceptions of telehealth primary care
video visits.’’ The Annals of Family Medicine 15.3
(2017): 225–229.
94 We are planning a separate proposal on
expanding who can bill for IPC, including clinical
psychologists, LCSWs, marriage and family
therapists (MFTs), and MHCs; see further
discussion in section II.I of this proposed rule.
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BHI is a term that refers broadly to
collaborative care that integrates
behavioral health services with primary
care. BHI is a team-based approach to
care that focuses on integrative
treatment of patients with medical and
mental or behavioral health conditions.
For BHI in particular, including CPT
codes 99492, 99493, 99494, and 99484
and HCPCS code G0323, we are also
seeking information regarding how
evolving changes in practice may
warrant reconsideration of payment and
coding policies.
We propose that the care management
and CTBS codes that are identified in
Table 19 could not be separately billed
with the APCM codes for the same
beneficiary by the same practitioner, or
a different one within the same practice,
for the same service period. This would
prevent duplicative payments for
substantially similar services and is
consistent with how we have paid for
potentially overlapping care
management services in the past.
As we refine our APCM policies, we
note that we are not currently proposing
to make changes to the coding and
payment policies for the existing care
management and CTBS services, other
than to prohibit concurrent billing for
the same patient during the same month
by the same practitioner or another in
the same practice. For CY 2025, those
codes would still be available for
practitioners who do not furnish care
using the advanced primary care model
or who may prefer to document the
existing care management and CTBS
codes rather than use the new proposed
APCM codes.
We are also seeking comment on
potential overlap between APCM
services and other services currently
paid under the PFS, including but not
limited to care management and care
coordination and other CTBS. If
interested parties identify overlaps
between APCM and other services, we
are seeking comment on whether the
degree of overlap would warrant a
policy to restrict the services from being
billed concurrently with APCM. We also
seek comment on whether any overlap
would depend upon whether the same
or a different practitioner reports the
services.
As we test new CMS Innovation
Center models that include payments
for the services defined above, including
CCM, PCM, TCM, interprofessional
consultation, remote evaluation of
patient videos/images, virtual check-in,
and e-visits, or as changes in the
advanced primary care model of care or
more general changes to Medicare
payment policy take place that affect
existing CMS Innovation Center models,
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consistent with existing policy, we will
address potential overlaps between
payments made to model participants
with our proposed payment for APCM,
elements of the proposed APCM service,
and these duplicative services, and seek
to implement appropriate payment
policies.
e. Valuation of APCM Services—
GPCM1, GPCM2, and GPCM3
To improve the accuracy of payment
for the kinds of services furnished as
part of advanced primary care and
reduce the administrative burden
associated with current coding and
billing rules, we are proposing to create
three HCPCS codes to use for reporting
the proposed APCM service (GPCM1,
GPCM2, and GPCM3) (sections II.G.2.b.
and II.G.2.c. of this proposed rule).
Although these codes are unique in that
they would be created to differentially
pay for advanced primary care
management, the proposed APCM
services incorporate elements of existing
services with the understanding that
some patients will require more
resources and some fewer based on
variability in patient complexity and
needs (see section II.G.2.b of this
proposed rule). As we ordinarily do, we
are proposing to base the PFS valuation
for APCM codes on the resources
involved in furnishing the typical case
of the service which may not necessarily
reflect the actual resources involved in
furnishing every individual service.
In this section, we detail our proposed
methods to identify a typical case and
set of resources involved in furnishing
APCM, and the proposed valuation of
these codes. To value APCM, we
compared the service elements
described by the proposed APCM codes
to the values we have established for the
specific care management and CTBS
codes on which we modeled the
proposed the service elements of the
APCM codes and which we built into
the service descriptors for GPCM1,
GPCM2, and GPCM3 (see Table 19 and
sections II.G.2.b. through II.G.2.d. of this
proposed rule). As stated above, we
believe that the proposed elements of
APCM services reflect the
comprehensive approach to care
management involved in care delivery
using the advanced primary care model.
This is a model of primary care that is
being integrated into current medical
practice. As such, we believe that it
would be appropriate to use the current
valuation and uptake of the codes on
which we modeled the APCM codes to
inform our valuation of APCM services.
Using Medicare FFS claims data and
evidence from our primary care models,
we sought to understand how these
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different services have been used
historically and relate that information
to the way we are thinking about the
service elements for APCM and the
valuation of the three APCM code
levels. We know that for Medicare
beneficiaries who receive care
management services during a year, the
non-complex CCM base code is billed
on average for five months and with
three add-on codes during those five
months. We also know that initial
information from practitioner interviews
conducted as part of our CCM
evaluation efforts indicates that
practitioners overwhelmingly meet and
exceed the 20-minute threshold time for
billing the non-complex CCM base code;
typically, these practitioners reported
spending between 45 minutes and an
hour per month on CCM services for
each patient, with times ranging
between 20 minutes and several hours
per month (81 FR 80244). However, this
does not account for the care
management services that are provided
beyond one time-based billing interval
and without reaching the next; nor does
it account for the resources involved in
maintaining certain advanced primary
care practice capabilities and
continuous readiness and monitoring
activities, including patient population
monitoring and care needs assessment,
to fully furnish and bill APCM services
as is medically reasonable and
necessary for any individual patient
during any calendar month. Finally, this
does not account for changes to
utilization of APCM that may occur as
a result of the billing and
documentation requirements for APCM
services when compared to the current
coding and payment for care
management and CTBS services. While
our aim is to value APCM services based
on refined assumptions that we believe
better recognize likely utilization of the
new proposed codes and the work
required to furnish APCM services, this
is challenging without more
information. We welcome comments on
ideas for other sources of data that
would help us to assess APCM services
valuation.
We considered various alternatives for
valuing the APCM services and how
these may impact the broader health
care landscape given that primary care
is of such import across the country. We
are proposing to set baseline APCM
code values for this first year based on
historical utilization of the care
management services we have drawn
upon in designing the APCM codes. We
note that utilization of the care
management services has been
significantly higher than CTBS, and we
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found that CTBS are not typically billed
for a patient in the same month as care
management services. It is unclear
whether the kinds of services described
by the CTBS are not typically provided
during these months or whether they are
being provided but not separately
reported. We will continue to seek
information, including from public
comments on this proposed rule, to help
us identify the best approach to
reflecting the proposed CTBS elements
incorporated into the APCM monthly
bundle, and we are particularly
interested in data that could illuminate
differences between what services are
furnished and what is being reported
separately. We will continue to consider
refinements to the valuation of APCM
codes to reflect available information
about changes in the volume and mix of
care management and communication
activities being furnished as part of
APCM services in the delivery of
advanced primary care.
For APCM Level 1, we assumed the
typical case would involve fewer
resources than the current care
management services based upon the
proposed GPCM1 code descriptor and a
broad eligible population that would
require limited monthly APCM services;
however, it would also involve certain
resources inherent to maintaining
advanced primary care practice
capabilities and continuous readiness
and monitoring activities, including
patient population monitoring and care
needs assessment, to fully furnish and
bill APCM. As described in sections
II.G.2.b. and II.G.2.c. above, certain
elements of the APCM service require
resources to maintain continuous
readiness and monitoring activities to
furnish covered services consistent with
the advanced primary care model of
care. We concluded that the APCM
Level 1 services would be similar in
work to that of two billing units of the
non-complex code for CCM services
(CPT code 99490 (CCM services
provided by clinical staff per calendar
month)) over the course of a year, and
therefore based the proposed inputs on
CPT code 99490 multiplied by 1⁄6 (or 2
units over 12 months). Specifically, we
proposed a work RVU for GPCM1 of
0.17, which is the work RVU for CPT
code 99490 multiplied by 1⁄6. The
resulting proposed PE and MP RVUs are
proportionately similar to those for CPT
code 99490 and are available in
Addendum B (see https://www.cms.gov/
medicare/payment/prospectivepayment-systems/hospital-outpatient/
addendum-a-b-updates).95 Table 23
95 https://www.cms.gov/medicare/payment/feeschedules/physician/federal-regulation-
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displays payment amount estimates
using the 2024 PFS Conversion Factor.
For APCM Level 2, which describes
APCM services to patients with two or
more chronic conditions we assumed
the typical, higher intensity work
associated with managing a patient with
multiple chronic conditions would
involve significantly more resources and
require more, and more frequent, APCM
service elements. We concluded that the
APCM Level 2 services would be similar
to current utilization assumptions of
five billing units of the non-complex
CCM code (CPT codes 99490) (CCM
services provided by clinical staff per
calendar month) and three billing units
of add-on codes annually, given that, for
Medicare beneficiaries who receive
these CCM services during a year, the
non-complex CCM base code is billed
on average for five months and with
three add-on codes during those 5
months. Additionally, we are proposing
to account for what we believe to be
continued underutilization of CCM
services in this patient population by
adding one billing unit of the complex
CCM code (CPT code 99490 (CCM
services provided by clinical staff per
calendar month) annually. As we noted
in the CY 2020 PFS final rule,
‘‘utilization [of CCM services] has
reached approximately 75 percent of the
level we initially assumed under the
PFS when we began paying for CCM
services separately under the PFS; while
these are positive results, we believe
that CCM services (especially complex
CCM services) continue to be
underutilized’’, 81 FR 80244 and 84 FR
62688, considering the number of
eligible Medicare beneficiaries. In 2019,
approximately 22.6 million FFS
beneficiaries were identified as being
potentially eligible for CCM (or 63.4
percent of the 35.6 million Medicare
FFS beneficiaries); however, the use of
CCM services was low among
potentially eligible beneficiaries, such
that just 4.0 percent of beneficiaries
potentially eligible for CCM received
any CCM services.96 Therefore, we
based the proposed inputs on CPT code
99490 multiplied by 5⁄12 (or, five units
notices?DLSort=2&DLEntries=10&DLPage
=1&DLSortDir=descending.
96 The determination of potential eligibility for
CCM was based on presence of two or more Chronic
Condition Warehouse (CCW) chronic condition
flags, one of which was hypertension,
hyperlipidemia, or diabetes. Beneficiaries on
Medicare Advantage, with end stage renal disease
(ESRD) or using the hospice benefit were excluded.
ASPE. Analysis of 2019 Medicare Fee-for-Service
(FFS) Claims for Chronic Care Management (CCM)
and Transitional Care Management (TCM) Services.
March 2022. https://aspe.hhs.gov/sites/default/
files/documents/31b7d0eeb7decf52f
95d569ada0733b4/CCM-TCM-DescriptiveAnalysis.pdf.
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over 12 months), plus CPT add-on code
99439 (CCM services each additional 30
minutes by clinical staff directed by a
physician or other qualified health care
professional, per calendar month)
multiplied by 1⁄6 (or two units), plus
CPT add-on code 99489 (Complex CCM
services each additional 30 minutes by
clinical staff directed by a physician or
other qualified health care professional,
per calendar month) multiplied by 1⁄12
(one unit), plus CPT code 99487
(Complex CCM services provided by
clinical staff directed by a physician or
other qualified health care professional,
per calendar month) multiplied by 1⁄12
(one unit). Specifically, we proposed a
work RVU for GPCM2 of 0.77, which is
the sum of the work RVU for CPT codes
99490, 99439, 99489, and 99487
multiplied by their respective
proportions above. The resulting
proposed PE and MP RVUs are
proportionately similar and are
available in Addendum B (see https://
www.cms.gov/medicare/payment/
prospective-payment-systems/hospitaloutpatient/addendum-a-b-updates).97
Table 23 displays payment amount
estimates using the 2024 PFS
Conversion Factor.
For APCM Level 3 (HCPCS code
GPCM3), which describes APCM
services to patients with QMB status
and two or more chronic conditions, we
are proposing to value the service as a
relative increase to the valuation of
APCM Level 2 based on recent Medicare
expenditure data for dually eligible
Medicare beneficiaries. In CY 2021, per
person per year spending on dually
eligible beneficiaries was $24,370 and
for non-dually eligible beneficiaries was
$11,172. The difference between these
two amounts is 218 percent. We have
considered the likely resource demands
and intensity of the practitioner-patient
interaction for this patient population,
consistent with our coding and
valuation policies that reflect variations
in resource cost and patient-centered
care delivery policies.98 By taking into
consideration the difference in Medicare
spending on a per person per year basis
between dually eligible and non-dually
eligible Medicare beneficiaries, we
believe that we can capture the
increased resources involved in
furnishing APCM services to patients
with QMB status and multiple chronic
conditions. Therefore, we based the
proposed inputs for the APCM Level 3
code on the APCM Level 2 inputs
multiplied by 218 percent. Specifically,
we proposed a work RVU for GPCM3 of
1.67, which is the proposed work RVU
for GPCM2 multiplied by 218 percent.
The resulting proposed PE and MP
RVUs are proportionately similar to
those and are available in Addendum B
(see https://www.cms.gov/medicare/
payment/prospective-payment-systems/
hospital-outpatient/addendum-a-bupdates).99 Table 23 displays payment
amount estimates using the 2024 PFS
Conversion Factor.
Table 23 includes the proposed
placeholder codes (which, if finalized,
will be replaced with numeric G-codes
announced in the final rule), short
descriptors, crosswalk codes, proposed
RVUs (work, PE, and MP), and
approximate payment rate. For
illustration purposes, we multiplied the
proposed APCM relative values for
work, practice expense (PE), and
malpractice (MP), without geographic
adjustment, by the CY 2024 conversion
factor (CF) ($32.7442) to convert the
proposed relative value units (RVUs)
into approximate national payment
rates.
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CM for patients with
GPCMl up to one chronic
ondition
CM for patients with
ultiple (two or more)
hronic conditions
CMforQMBs
nrollees with multiple
hronic conditions
99490
0.17
0.14
0.01
0.31
$10
99490,99439,99487,
99489
0.77
0.72
0.05
1.54
$50
Calculated as a relative
increase from GPCM2
1.67
1.57
0.12
3.36
$110
We are seeking feedback on whether
these proposed values appropriately
reflect the resource costs involved in
furnishing these services, or whether
adjustments to the proposed values or
additional coding may be needed. We
are broadly interested in public
comments and input from interested
parties on potential refinements in code
and service definitions, including how
we might refine our utilization
assumptions for these codes, and other
important information involving coding
and payment for APCM services to
better reflect the current practice of
advanced primary care, including
elements of CTBS and care management
services. We are interested in
developing a better understanding of the
resource costs involved in furnishing
comprehensive care management as part
of advanced primary care to various
patient populations, including
specifically QMBs.
We intend to engage in further
discussions with the public over the
next several years to potentially refine
our policies for 2025 and future years,
and we expect that having APCM
utilization data, once the proposed
codes are established, would inform
future refinement of the valuations for
these codes.
Finally, as described in the Advanced
Primary Care RFI that follows, we note
that there is potential for the valuation
of these codes and future related codes
to change and/or scale into larger units
if we expand them to incorporate more
97 https://www.cms.gov/medicare/payment/feeschedules/physician/federal-regulationnotices?DLSort=2&DLEntries=
10&DLPage=1&DLSortDir=descending.
98 https://www.macpac.gov/wp-content/uploads/
2024/01/Jan24_MedPAC_MACPAC_
DualsDataBook-508.pdf.
99 https://www.cms.gov/medicare/payment/feeschedules/physician/federal-regulationnotices?DLSort=2&DLEntries=10&DLPage=
1&DLSortDir=descending.
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service elements (see section II.G.3. of
this proposed rule). As we receive more
information about how these codes are
being used and implemented in medical
practice, we anticipate that these codes
and future related codes will be refined
over time. We note that the
development of payment and coding
policies for these and other kinds of
services under the PFS is typically an
iterative process that responds to
changes in medical practice and may be
best refined over several years through
annual rulemaking for the PFS, and
through the development of CPT codes
by the AMA’s CPT Editorial Committee.
As described in the next section, we
believe that this new proposed APCM
code set could serve as a chassis to
incorporate primary care model
learnings over time under the PFS and
an additional pathway to accountable
care for primary care practitioners.
3. Request for Information: Advanced
Primary Care Hybrid Payment
a. Background
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Recent evidence reviews show that
while primary care is the only part of
the health system in which investments
routinely result in not only improved
outcomes but also increased equity,100
the practice and sustainability of the
primary care sector is under significant
strain.101 The NASEM found that many
of these challenges relate to a primary
care payment system that principally
rewards visit volume versus creation
and maintenance of longitudinal 102 care
relationships over time.103 We have set
a goal of having 100 percent of
traditional Medicare beneficiaries and
the vast majority of Medicaid
beneficiaries in accountable care
relationships by 2030. Accountable care
occurs when a person-centered care
team takes responsibility for improving
quality of care, care coordination and
health outcomes for a defined group of
individuals, to reduce care
fragmentation and avoid unnecessary
costs for individuals and the health
100 National Academies of Sciences, Engineering,
and Medicine (NASEM); Implementing HighQuality Primary Care (https://nap.national
academies.org/read/25983).
101 Milbank Memorial Fund, The Health of US
Primary Care: 2024 Scorecard (https://
www.milbank.org/wp-content/uploads/2024/02/
Milbank-Scorecard-2024-ACCESS_v06.pdf).
102 Longitudinal care management is long-term,
proactive, relationship-based care management that
augments routine and acute visits with intentional,
proactive outreach, especially during times of
illness and transitions of care.
103 NASEM, Implementing High-Quality Primary
Care (https://nap.nationalacademies.org/read/
25983).
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system.104 Advanced primary care is a
core mechanism for achieving this goal.
With this goal, we acknowledge the
need to increase the capability of
primary care clinicians to engage,
maintain, and promote longitudinal and
accountable relationships with
beneficiaries through incentives and
flexibilities to manage quality and total
cost of care.
Over the past 11 years, the CMS
Innovation Center has tested a number
of primary care models: CPC, CPC+,
Maryland Primary Care Program, PCF,
as well as the upcoming MCP and ACO
Primary Care Flex. Each of these
primary care models has focused on
testing what happens when we pay for
primary care services with hybrid
payments (a mix of fee-for-service and
population-based payments), as
described earlier. While these models
have not met the criteria for expansion
to date, the findings suggest advanced
primary care may reduce unnecessary
utilization and improve diabetes care
and cancer screening rates.
In addition to testing new approaches
to improve care for beneficiaries by
supporting primary care, we have
focused on approaches to incorporating
these innovations into Medicare
programs. For example, lessons learned
from the CMS Innovation Center’s ACO
models may be incorporated into the
Shared Savings Program. As such, part
of the intent of our proposal to create
new APCM payment and coding is that
we would have a similar foundation to
scale advanced primary care model
learnings over time.
Previous Innovation Center primary
care model tests have helped us learn
lessons to inform our current and future
work. For example, participants in
primary care models have indicated
difficulty investing in and maintaining
primary care redesign activities due to
a range of challenges. First, additional
non-visit-based primary care payments
have been generally layered upon base
payments still predominantly FFS in
structure. As such, the incentives and
abilities of practices to focus on
proactive, population-based non-visit
activities may be limited if the funding
stream for these activities is limited in
scope and duration.105 106 (Examples of
104 https://www.cms.gov/priorities/innovation/
key-concepts/accountable-care-and-accountablecare-organizations.
105 Independent Evaluation of Comprehensive
Primary Care Plus (CPC+): Final Report. https://
www.cms.gov/priorities/innovation/data-andreports/2023/cpc-plus-fifth-annual-eval-report.
106 Schurrer J, Timmins L, Gruszczynski M, et al.
Evaluation of the Primary Care First Model: Second
Annual Report. Mathematica. February 2024.
https://www.cms.gov/priorities/innovation/dataand-reports/2024/pcf-second-eval-rpt.
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non-visit-based activities include, but
are not limited to: activities to improve
care coordination, implement datadriven quality improvement, or enhance
targeted care management for
beneficiaries identified as high-risk.)
Further, model funding for the clinical
and administrative staff needed to
accomplish advanced primary care
coordination and population health
functions is contingent on continued
participation in these models.107 Once
the models end, practices are left
without the funding that they received
under the models for the clinical and
administrative staff that had supported
population health functions under the
model. Moreover, because these models
involve additional payments tied to
performance rather than changes to base
primary care payment, practices report
that the funding they use to support
non-visit activities is sometimes
received well after the non-visit services
have occurred, leading to further
challenges sustaining these efforts
fiscally. Solving these challenges is a
key goal of future Innovation Center
model work.108
To strengthen the primary care
infrastructure within FFS Medicare, we
are exploring opportunities to create
new sustainable pathways to support
advanced primary care, equitable access
to high-quality primary care, and
continued transformation among a wide
variety of practices. One potential
strategy to increase access to advanced
primary care and prepare practitioners
in traditional Medicare to engage in
more accountable care is through the
creation and ongoing refinement of
specific billing and coding under the
PFS that better recognizes advanced
primary care and incorporates the
resources involved in furnishing
longitudinal care and maintaining
relationships with patients over time. In
section II.G.2. of this proposed rule, we
are proposing a set of APCM services
that make use of lessons learned from
the CMS Innovation Center’s primary
care models, grouping existing care
management and CTBS service elements
into a bundle for use starting in CY
2025.
We are seeking feedback regarding
potential further evolution in coding
and payment policies to better recognize
advanced primary care. Through this
Advanced Primary Care RFI, we are
committed to collaborating with
107 CMS defines population health as health
behaviors and outcomes of a broad group of
individuals, including the distribution of such
outcomes affected by the contextual factors within
the group.
108 https://www.cms.gov/about-cms/what-we-do/
cms-strategic-plan.
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interested parties to lay the path for a
more transparent movement to valuebased care. Specifically, we are
requesting input on a broader set of
questions related to care delivery and
incentive structure alignment and five
foundational components:
• Streamlined Value-Based Care
Opportunities
• Billing Requirements
• Person-Centered Care
• Health Equity, Clinical, and Social
Risk
• Quality Improvement and
Accountability
We encourage input on the questions
below from diverse voices, including
beneficiaries and advocates,
community-based organizations,
providers, clinicians, researchers,
unions, and all other interested parties.
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b. Solicitation of Public Comments
We are seeking feedback regarding
potential changes to coding and
payment policies for advanced primary
care services to be incorporated in
traditional Medicare. For example, in
the future, coding for APCM services
(proposed in section II.G.2. of this
proposed rule) could be revised to
include additional service elements,
including traditional E/M services. This
Advanced Primary Care RFI is designed
to solicit feedback on how we can
further the goals of reducing
administrative burden to refocus time
on patient care; better recognizing the
relative resources involved in furnishing
care; recognizing interdisciplinary,
team-based primary care; and
supporting primary care sustainability
and stability (especially for underserved
communities). Whenever possible,
respondents are requested to draw their
responses from objective, empirical, and
actionable evidence and to cite this
evidence within their responses. We
anticipate potential changes to primary
care coding and payment policies, such
as use of coding that recognizes groups
of services furnished over a fixed time
period, that would offer a new
opportunity within the PFS for primary
care clinicians to move to payment
structures that are not fully dependent
on billing for each discrete component
of overall care and act as a step toward
accountability for the cost and quality of
patient care. Therefore, we are seeking
feedback on building advanced primary
care payment mechanisms that create
pathways to recognize how primary care
practice has moved away from an
encounter-based orientation toward
population-based care. This Advanced
Primary Care RFI is the first step in
ensuring ample opportunity for public
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input, followed by notice and comment
rulemaking in subsequent years.
(1) Streamlined Value-Based Care
Opportunities
We are seeking to create a
steppingstone for primary care
clinicians, including those new to
value-based care, to move away from
either encounters or other discrete
components of overall care as the
dominant method of primary care
payment and toward payments in larger
units that are better tied to the relative
resource costs involved in populationbased, longitudinal care. Feedback from
interested parties has been helpful when
considering how to scale the availability
of payments into larger units, and
incorporate population-based variability
in resources, all while driving toward
accountability, and person-centered
care. Ultimately, to create more
opportunities for beneficiaries to receive
high-quality, accountable primary care,
we are focused on creating multiple
pathways to recognize delivery of
integrated care across settings, and
engagement in comprehensive, teambased, longitudinal care.
When considering the evolution of a
hybrid payment system within the PFS,
we seek input on the following
questions:
• How can CMS better support
primary care clinicians and practices
who may be new to population-based
and longitudinal care management?
• What are the primary barriers to
providing particular strategies or
supports needed for pediatric clinicians
and practices?
• How can CMS ensure that potential
future advanced primary care payment
will not induce clinicians to leave
effective accountable care relationships
and clinician networks that already
produce positive results? Additionally,
how can CMS support growth over time
in existing effective accountable care
relationships and clinician networks?
• Should CMS evolve the proposed
APCM services into an advanced
primary care payment that includes E/
M and other relevant services, or
maintain a separate code set for APCM?
• If E/M services are bundled together
for advanced primary care payments,
how can CMS ensure that there is not
a disincentive for primary care
clinicians to continue to provide E/M
visits, or increase accountability to E/M
visits as warranted?
• As many codes depend on E/M
visits (for example, as the base code for
an add-on code, or to initiate specific
care management activities), how
should CMS consider the downstream
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impacts of incorporating E/M visits into
advanced primary care payments?
• Should CMS consider incorporating
other CTBS services into advanced
primary care hybrid payments, such as
Remote Physiologic Monitoring and/or
Remote Therapeutic Monitoring?
• Should CMS consider incorporating
other services that involve
comprehensive care management and
care coordination, such as Behavioral
Health Integration, End-Stage Renal
Disease Monthly Capitation Payment
(ESRD MCP), Assessment/Care Planning
for Cognitive Impairment, and/or
Advance Care Planning?
• Should CMS consider incorporating
other services while the patient is under
care of home health agencies or
hospices, such as Care Plan Oversight?
• Newly finalized HCPCS codes are
eligible for use by other payers,
including commercial insurers, state
Medicaid agencies, and others. We note
that value-based alignment is a key goal
of CMS. If the APCM codes are
finalized, they would be eligible for use
by these other payers as well. To what
extent are other payers interested in
adopting the APCM codes? Are there
any other changes that would be
necessary for other payers to adopt the
codes?
• CMS has historically used
information presented by the Relative
Value Scale Update Committee to
determine PFS payment rates. Are there
other sources of data on the relative
value of primary care services that CMS
should consider when setting hybrid
payment rates?
(2) Billing Requirements
Previous CMS Innovation Center
primary care models have provided key
lessons learned about how to increase
comfort with population-based
payments, the importance of reducing
the administrative burden of billing, and
how to begin addressing gaps in
equitable access to population-based
payments.109 Specifically, we have
learned through Innovation Center
initiatives that retrospective
reconciliation or adjustment of
payments for services rendered can be
especially frustrating for practitioners,
as it reduces the predictability and
stability of payments.110
109 Independent Evaluation of Comprehensive
Primary Care Plus (CPC+): Final Report. https://
www.cms.gov/priorities/innovation/data-andreports/2023/cpc-plus-fifth-annual-eval-report;
Independent Evaluation of Primary Care First:
Second Annual Report. https://www.cms.gov/
priorities/innovation/data-and-reports/2024/pcfsecond-eval-rpt.
110 Independent Evaluation of Primary Care First:
Second Annual Report. https://www.cms.gov/
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For these reasons, we are seeking to
understand how advanced primary care
hybrid payments can balance program
integrity, high-quality care, payment
stability, and clinician burden.
We seek input on the following
questions:
• How can CMS reduce the potential
burden of billing for population-based
and longitudinal care services?
• Are there particular types of items
or services that should be excluded from
the advanced primary care bundle?
• Are there particular services paid
under the PFS today that should be
included in the advanced primary care
bundle?
• Care management activities are
currently billed monthly. What episode
lengths should CMS consider when
thinking about an advanced primary
care bundle of services for hybrid
payment? Include evidence to support
the proposed episode length.
• Should CMS attribute the advanced
primary care clinical episode to a single
clinician, or consider weighted
attribution and payment for multiple
entities or clinicians? How could
weighted attribution and payment
work? What rules or processes should
CMS consider to attribute the episode?
• Care management coding and
payment have historically required an
initiating visit prior to starting monthly
billing, to ensure that the services are
medically reasonable and necessary and
consistent with the plan of care. Are
there other ways that CMS could ensure
the clinician billing APCM is
responsible for the primary care of the
Medicare beneficiary?
• Care management coding and
payment require beneficiary cost
sharing. Has beneficiary cost sharing
been a barrier to practitioners providing
such services?
• Consistent with the initiating visit
requirement in the APCM proposal,
should CMS require the billing of
specific qualifying services for billing of
an advanced primary care bundle that is
larger in scale and scope than APCM?
• Are there Health IT functions
beyond what is proposed for APCM
services that clinicians should be
required to have to bill for an advanced
primary care bundle? What should CMS
consider in the design of the advanced
primary care bundle to effectively
incorporate Health IT standards and
functionality, to support interoperability
and the aims of advanced primary care?
• Should CMS limit the types of nonphysician clinicians that can bill for an
advanced primary care bundle that is
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larger in scale and scope than APCM? If
so, include evidence to support the
restriction.
• How should CMS reconcile
instances where an advanced primary
care bundle is billed, but primary care
services are then billed for and provided
by separate entities?
(3) Person-Centered Care
Person-centered care integrates
individuals’ clinical needs across
providers and settings, while addressing
their social needs.111 We strive for
better, more affordable care and
improved health outcomes. Key to this
mission are care innovations that
empower beneficiaries and clinicians,
while reducing the administrative
burden of providing episode-based and
longitudinal care management. We are
seeking comment on how an advanced
primary care code(s) could be structured
to both increase efficiency and promote
the use of high-value services.
We seek input on the following
questions:
• What activities that support the
delivery of care that is coordinated
across clinicians, support systems, and
time should be considered for payment
in an advanced primary care bundle that
are not currently captured in the PFS?
• How can CMS structure advanced
primary care hybrid payments to
improve patient experience and
outcomes?
• How can CMS structure advanced
primary care hybrid payments to ensure
appropriate access to telephonic and
messaging primary care services?
• What is the best reporting structure
to ensure that targeted services are
delivered without causing undue or
excessive documentation?
• How can CMS facilitate
coordination between primary care
clinicians that bill for advanced primary
care bundles and specialists to reduce
costs and improve patient outcomes?
(4) Health Equity, Social and Clinical
Risk
We define health equity as, ‘‘the
attainment of the highest level of health
for all people, where everyone has a fair
and just opportunity to attain their
optimal health regardless of race,
ethnicity, disability, sexual orientation,
gender identity, socioeconomic status,
geography, preferred language, or other
factors that affect access to care and
health outcomes.’’ 112 The CMS
111 CMS White Paper on CMS Innovation Center’s
Strategy: Driving Health System Transformation—A
Strategy for the CMS Innovation Center’s Second
Decade (https://www.cms.gov/priorities/innovation/
strategic-direction-whitepaper).
112 https://www.cms.gov/pillar/health-equity.
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Framework for Health Equity lays out
how we are working to advance health
equity by designing, implementing, and
operationalizing policies and programs
that support health for all the people
served by our programs, eliminating
avoidable differences in health
outcomes experienced by people who
are disadvantaged or underserved, and
providing the care and support that our
beneficiaries need to thrive.113 For
advanced primary care hybrid
payments, this may mean incorporating
different types of social and clinical risk
into the payment than have typically
been considered in traditional E/M or
care management codes.
Recent models such as ACO
REACH 114 and Making Care Primary 115
have incorporated risk adjustment for
social risk factors, such as Part D Low
Income Subsidy enrollment status and
Area Deprivation Index, to better
capture factors relevant to care of the
patient. We seek input on how
advanced primary care billing and
payment policy could be used to reduce
health disparities and social risk.
Furthermore, we are seeking to balance
a simple payment structure that
encourages the uptake of advanced
primary care services, while ensuring
that the risk adjustment method used to
develop the payment rates incentivizes
the appropriate coding of patient
conditions and needs, including those
that have previously been underdocumented, such as dementia and
patient frailty.116
We seek input on the following
questions:
• What non-claims-based indicators
could be used to improve payment
accuracy and reduce health disparities,
and how can CMS ensure that they are
collected uniformly and documented
consistently without unduly increasing
administrative burden?
• What risk factors, including clinical
or social, should be considered in
developing payment for advanced
primary care services?
113 Centers for Medicare & Medicaid Services, The
CMS Framework for Health Equity (2022–2032).
April 2022. https://www.cms.gov/files/document/
cms-framework-health-equity-2022.pdf.
114 https://www.cms.gov/priorities/innovation/
innovation-models/aco-reach.
115 https://www.cms.gov/priorities/innovation/
innovation-models/making-care-primary.
116 National Academies of Sciences, Engineering,
and Medicine (NASEM); Committee on the Decadal
Survey of Behavioral and Social Science Research
on Alzheimer’s Disease and Alzheimer’s DiseaseRelated Dementias. Reducing the Impact of
Dementia in America: A Decadal Survey of the
Behavioral and Social Sciences. National
Academies Press. July 26, 2021. https://
nap.nationalacademies.org/catalog/26175/
reducing-the-impact-of-dementia-in-america-adecadal-survey.
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• How can CMS account for apparent
changes in risk that are due to changes
in coding patterns rather than changes
in health status?
• What risk adjustments should be
made to proposed payments to account
for higher costs of traditionally
underserved populations?
• What indicators are used to capture
added social risk in commercial
insurance? Should CMS consider using
these?
• What metrics should be used or
monitored to adjust payment to ensure
that health disparities are not worsened
as an unintended consequence?
• How can CMS ensure that advanced
primary care hybrid payment increases
access to health care services for
patients without a usual source of
primary care?
• Are there steps CMS can take to
ensure advanced primary care billing
and coding is utilized for dually eligible
beneficiaries, and by safety net
providers?
• Should CMS incorporate
Community Health Integration and/or
Principal Illness Navigation services
and payment into an advanced primary
care bundle?
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(5) Quality Improvement and
Accountability
We are committed to affordable
quality health care for all people with
Medicare. We seek feedback regarding
how we can continue to strengthen
beneficiary access to high-quality health
services within FFS Medicare. One goal
of the CMS Innovation Center Strategy
Refresh is to increase the capability of
practitioners furnishing advanced
primary care to engage in accountable
care relationships with beneficiaries
through incentives and flexibilities to
manage clinical quality, outcomes,
patient experience, and total cost of
care. As such, part of the intent of
evolving and creating over time
advanced primary care hybrid payments
is that the practitioners who bill for
these services are engaged in a
relationship where they are responsible
for the quality and cost of care for the
beneficiary, counting toward the overall
2030 goal of every person with
Traditional Medicare being in an
accountable care relationship. This
Advanced Primary Care RFI seeks input
from beneficiaries and their caregivers,
primary care and other clinicians, and
health plans on how advanced primary
care bundles could support that goal.
We seek input on the following
questions:
• How can CMS ensure clinicians
will remain engaged and accountable for
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their contributions to managing the
beneficiary’s care?
• What are key patient-centered
measures of quality, outcomes and
experience that would help ensure that
hybrid payment enhances outcome and
experience for patients?
• How could measures of quality,
outcomes, and experience guard against
and decrement in access or quality?
• As described in the APCM
proposal, reporting of the ‘‘Value in
Primary Care’’ MVP would be an APCM
service element for MIPS eligible
clinicians beginning in 2026. Since this
MVP contains measures focused on both
the total cost and quality of care, would
its inclusion as an APCM service
element be sufficient to count as
‘‘accountable care?’’ If not, what other
service delivery or quality reporting
would be expected in ‘‘accountable
care?’’
• What should CMS consider so that
that advanced primary care bundles
could be used to promote accountable
care across payers, both commercial and
Medicaid?
• What quality measures are other
payers using to drive improvements in
primary care?
• What utilization measures are other
payers using to drive improvements in
primary care?
• What patient experience measures
are other payers using to drive
improvements in primary care?
• Should CMS consider flexibilities
for smaller practices to bill the
advanced primary care bundle? Should
CMS consider flexibilities for entities
exempt from MIPS to bill the advanced
primary care bundle?
• Would clinicians be willing to take
on more accountability to further reduce
the frequency and/or administrative
burden of billing?
• For APCM services, are there other
key practice-level elements of the
service that should be considered for
advanced primary care practices to bill
for advanced primary care?
4. Cardiovascular Risk Assessment and
Risk Management
a. Background
Cardiovascular disease (CVD) is a
leading cause of death, disability, and
health care expenditures in the U.S.117
The burden of CVD is unequal, with
black Americans experiencing higher
rates of CVD-related morbidity than
white Americans.118 Atherosclerotic
117 Heart Disease and Stroke Statistics—2023
Update: A Report from the American Heart
Association Connie W. Tsao, MD, MPH, FAHA et.
al. Circulation. 2023;147:e93–e621.
118 Cardiovascular Health in African Americans:
A Scientific Statement From the American Heart
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CVD 119 is also distinct among leading
causes of death for Americans in the
proportion of CVD attributable to
behavioral causes,120 making
improvement in modifiable CVD risk
factors (for example, diet, exercise,
smoking cessation) is a key treatment
target to reduce the burden of CVD
across populations.121
The CMS Innovation Center’s Million
Hearts® Cardiovascular Disease (CVD)
Risk Reduction model 122 (hereafter
referred to as Million Hearts® model)
was launched in 2017 as part of the
ongoing HHS Million Hearts®
Initiative.123 The model’s goals were to
decrease the incidence of first-time
heart attacks and strokes among
medium and high-risk Medicare
beneficiaries over five years and reduce
Medicare spending on cardiovascular
events. The model was implemented as
a randomized design where participant
organizations in the intervention group
agreed to (1) calculate traditional
Medicare beneficiaries’ risk of having a
heart attack or stroke over 10 years, and
(2) provide cardiovascular care
management services to high-risk
patients (defined as a risk of a
cardiovascular event in the next decade
of greater than thirty percent). The
model also identified medium-risk
patients (more than fifteen percent risk
of an event in the next decade) in its
evaluation. In exchange for doing so,
CMS paid participant organizations $10
for each eligible traditional Medicare
beneficiary for whom the organizations
assessed risk, and in the first year of the
model, $10 for each high-risk
beneficiary during each month when
cardiovascular care management
services were provided.124 In
Association Mercedes R. Carnethon, Ph.D., FAHA et
al. Circulation. 2017;136:e393–e423.
119 What is Atherosclerosis? NIH NHLBI. https://
www.nhlbi.nih.gov/health/atherosclerosis.
120 Libby, P., Buring, J.E., Badimon, L. et al.
Atherosclerosis. Nat Rev Dis Primers 5, 56 (2019).
https://doi.org/10.1038/s41572-019-0106-z.
121 Ebrahim S, Taylor F, Ward K, Beswick A,
Burke M, Davey Smith G. Multiple risk factor
interventions for primary prevention of coronary
heart disease. Cochrane Database Syst Rev.
2011;(1):CD001561 https://pubmed.ncbi.
nlm.nih.gov/21249647/.
122 Sanghavi DM, Conway PH. Paying for
prevention: a novel test of Medicare value-based
payment for cardiovascular risk reduction. JAMA.
2015;314(2):123–124. https://jamanetwork.com/
journals/jama/fullarticle/2300705.
123 Frieden TR, Berwick DM. The ‘‘Million
Hearts’’ initiative: preventing heart attacks and
strokes. N Engl J Med. 2011;365(13):e27. https://
pubmed.ncbi.nlm.nih.gov/21913835/.
124 Blue L, Kranker K, Markovitz AR, et al. Effects
of the Million Hearts Model on Myocardial
Infarctions, Strokes, and Medicare Spending: A
Randomized Clinical Trial. JAMA.
2023;330(15):1437–1447. doi:10.1001/
jama.2023.19597.
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subsequent years of the model (2018 to
2022) participants were expected to
reassess cardiovascular risk and were
paid based on cardiovascular risk
reduction ($0 to $10 per beneficiary per
month) for high-risk beneficiaries.
All CMS Innovation Center models
are independently evaluated 125 and the
evaluation of the Million Hearts® model
found the model reduced the rate of
death from any cause for medium and
high-risk beneficiaries by four percent,
as well as reduced the risk of death from
a cardiovascular event (that is, heart
attack or stroke) by eleven percent.126
We consider this to be due to increased
rates of cardiovascular risk assessment,
discussion of cardiovascular risk by
participants’ clinicians, and the use of
appropriate medications to reduce
cardiovascular risk (for example, aspirin
and statins).127
During the Million Hearts® (MH)
model (which was tested from 2017–
2022), there was a recently-introduced
ASCVD risk assessment tool to
incorporate demographic (age, sex,
race), clinical (blood pressure,
cholesterol, history of diabetes), and risk
behavior (smoking status, use of antihypertensives, use of statins, use of
aspirin) established by the American
College of Cardiology (ACC),128 as well
as a longitudinal re-assessment tool
used within the model.129 This tool
calculated the 10-year risk of a
cardiovascular event for beneficiaries
ages 40–79. Subsequently, additional
125 Evaluation of the Million Hearts
Cardiovascular Disease Risk Reduction Model.
Final Report. August 2023. Mathematica. https://
www.cms.gov/priorities/innovation/data-andreports/2023/mhcvdrrm-finalannevalrpt.
126 Evaluation of the Million Hearts
Cardiovascular Disease Risk Reduction Model, p.
43. Final Report. August 2023. Mathematica.
https://www.cms.gov/priorities/innovation/dataand-reports/2023/mhcvdrrm-finalannevalrpt.
127 Evaluation of the Million Hearts
Cardiovascular Disease Risk Reduction Model, p.
26. Final Report. August 2023. Mathematica.
https://www.cms.gov/priorities/innovation/dataand-reports/2023/mhcvdrrm-finalannevalrpt.
128 Grundy SM, Stone NJ, Bailey AL, Beam C,
Birtcher KK, Blumenthal RS, Braun LT, de Ferranti
S, Faiella-Tommasino J, Forman DE, Goldberg R,
Heidenreich PA, Hlatky MA, Jones DW, Lloyd-Jones
D, Lopez-Pajares N, Ndumele CE, Orringer CE,
Peralta CA, Saseen JJ, Smith SC, Sperling L, Virani
SS, Yeboah J. 2018 ACC guideline on the
management of blood cholesterol: a report of the
American College of Cardiology Foundation/
American Heart Association Task Force on Clinical
Practice Guidelines. J Am Coll Cardiol. 2018.
https://tools.acc.org/ldl/ascvd_risk_estimator/
index.html#!/calulate/estimator/.
129 Lloyd-Jones DM, Huffman MD, Karmali KN,
Sanghavi DM, Wright JS, Pelser C, Gulati M,
Masoudi FA, Goff DC Jr. Estimating Longitudinal
Risks and Benefits From Cardiovascular Preventive
Therapies Among Medicare Patients: The Million
Hearts Longitudinal ASCVD Risk Assessment Tool:
A Special Report From the American Heart
Association and American College of Cardiology.
Circulation. 2017 Mar 28;135(13):e793–e813.
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ASCVD risk assessment tools have been
developed.130
Today in clinical practice, ASCVD
risk is generally calculated using a tool
combining demographic data, personal
history (risk behaviors and medical
history), and laboratory data (lipid
panel).131 This information is used to
calculate into a 10-year estimate of a
patient’s ASCVD risk for use in
determining treatment advice provided
by the treating practitioner. This
determination requires both data
collection at a visit and laboratory data,
which may not be available at an initial
visit. This change in clinical practice
occurred over time after a series of
guidelines from the American Heart
Association (AHA) recommended using
ASCVD risk in determining treatment
decisions for patients without a prior
history of CVD.132 This treatment
guideline also includes
recommendations for lifestyle
modifications for all patients. The CMS
Innovation Center Million Hearts®
model contributed to this change in
clinical practice by demonstrating
through a rigorous randomized control
trial that the quantitative assessment of
10-year cardiovascular risk improves
quality of care, including mortality,
compared to prior practice.133
In the Million Hearts® model,
cardiovascular-focused care
management services included an
initiating visit where an ASCVD risk
assessment is performed, structured
recording of patient health information
using CEHRT, and a comprehensive care
plan focused on cardiovascular risk
reduction (including the ABCS focused
on in the Million Hearts® model), but
did not require 24/7 access to care,
management of care transitions, or home
and community-based coordination
because these services are necessary for
the management of complex conditions
130 Leading Cardiologists reveal new
cardiovascular disease prevention risk calculator.
https://newsroom.heart.org/news/leadingcardiologists-reveal-new-heart-disease-riskcalculator#:∼:text=The%20American%20Heart%20
Association%20PREVENT,CKM%20syndrome%20
into%20CVD%20prevention.
131 2019 ACC/AHA Primary Prevention of
Cardiovascular Disease. https://
www.ahajournals.org/doi/pdf/10.1161/CIR.
0000000000000678.
132 Arnett DK et al. 2019 ACC/AHA Guideline on
the Primary Prevention of Cardiovascular Disease:
A Report of the American College of Cardiology/
American Heart Association Task Force on Clinical
Practice Guidelines. Circulation. 2019 Sep
10;140(11):e596–e646. doi: 10.1161/
CIR.0000000000000678.
133 Blue L, Kranker K, Markovitz AR, et al. Effects
of the Million Hearts Model on Myocardial
Infarctions, Strokes, and Medicare Spending: A
Randomized Clinical Trial. JAMA.
2023;330(15):1437–1447. doi:10.1001/
jama.2023.19597.
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placing a beneficiary at high risk of
death, acute exacerbation/
decompensation, or functional decline,
and these services are provided to
prevent the development of these
complex chronic conditions. In the
Million Hearts® model, cardiovascularfocused risk management services were
provided to beneficiaries at high risk for
CVD (more than a thirty percent risk of
a cardiovascular event in the next 10
years).
We interpret the findings of the
Million Hearts® model to be both
reflective of and perhaps augmenting an
evolution in clinical practice toward
quantitative ASCVD risk assessment.
We also do not believe the resources
involved in these activities are
appropriately reflected in current
coding and payment policies. As such,
we are proposing to establish codes to
describe a separately billable
cardiovascular disease risk assessment
that is furnished in conjunction with an
E/M visit and cardiovascular-focused
risk management, when reasonable and
necessary due to the presence of
increased cardiovascular risk factors
identified for the individual patient.
b. ASCVD Risk Assessment
We are proposing a new stand-alone
G-code, HCPCS code GCDRA,
Administration of a standardized,
evidence-based Atherosclerotic
Cardiovascular Disease (ASCVD) Risk
Assessment for patients with ASCVD
risk factors on the same date as an E/
M visit, 5–15 minutes, not more often
than every 12 months. Atherosclerotic
Cardiovascular Disease (ASCVD) Risk
Assessment refers to a review of the
individual’s demographic factors,
modifiable risk factors for CVD, and risk
enhancers for CVD. We are proposing
this new code to identify and value the
work involved in administering an
ASCVD risk assessment when medically
reasonable and necessary in relation to
an E/M visit.
We further propose that the ASCVD
risk assessment must be furnished by
the practitioner on the same date they
furnish an E/M visit, as the ASCVD risk
assessment would be reasonable and
necessary when used to inform the
patient’s diagnosis, and treatment plan
established during the visit. ASCVD risk
assessment is reasonable and necessary
for a patient who has at least one
predisposing condition to
cardiovascular disease that may put
them at increased risk for future ASCVD
diagnosis. These conditions could
include but are not limited to, obesity,
a family history of CVD, a history of
high blood pressure, a history of high
cholesterol, a history of smoking/
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alcohol/drug use, pre-diabetes, or
diabetes. We further propose that the
ASCVD risk assessment would not be
separately billable for patients with a
cardiovascular disease diagnosis or
those who have history of a heart attack
or stroke.
We are not proposing any specific tool
that would have to be used for the
ASCVD risk assessment, although the
assessment tool must be standardized
and evidence-based. Proposed elements
of the ASCVD risk assessment service
would include:
• Current (from the last 12 months)
laboratory data (lipid panel) for inputs
needed for the risk assessment tool.
• Administration of a standardized,
evidence-based ASCVD risk assessment
tool that has been tested and validated
through research, and includes the
following domains:
++ The output of the tool must
include a 10-year estimate of the
patient’s ASCVD risk. This output must
be documented in the patient’s medical
record.
++ Demographic factors (such as age,
sex).
++ Modifiable risk factors for CVD
(such as blood pressure & cholesterol
control, smoking status/history, alcohol
and other drug use, physical activity
and nutrition, obesity).
++ Possible risk enhancers (such as
pre-eclampsia, pre-diabetes, family
history of CVD).
++ Billing practitioners may choose to
assess for additional domains beyond
those listed above if the tool used
requires additional domains. Examples
of tools include but are not limited to,
the ACC ASCVD Risk Estimator 134 and
the ACC PREVENT tool.135 CMS expects
that the tool that is used would not
introduce discriminatory bias,
consistent with Section 1557 final rule.
We are proposing for HCPCS code
GCDRA to have a duration of 5–15
minutes for the administration of an
ASCVD risk assessment tool, billed no
more often than once every 12 months.
We are requesting comments on these
proposals, as well as information
134 Lloyd-Jones DM, Huffman MD, Karmali KN,
Sanghavi DM, Wright JS, Pelser C, Gulati M,
Masoudi FA, Goff DC Jr. Estimating Longitudinal
Risks and Benefits From Cardiovascular Preventive
Therapies Among Medicare Patients: The Million
Hearts Longitudinal ASCVD Risk Assessment Tool:
A Special Report From the American Heart
Association and American College of Cardiology.
Circulation. 2017 Mar 28;135(13):e793 e813.
135 Leading Cardiologists reveal new
cardiovascular disease prevention risk calculator.
https://newsroom.heart.org/news/leadingcardiologists-reveal-new-heart-disease-riskcalculator#:∼:text=The%20American%20
Heart%20Association%20PREVENT,
CKM%20syndrome%20i
nto%20CVD%20prevention.
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pertaining to potential clinician
education for these proposed codes.
(1) Proposed Valuation for ASCVD Risk
Assessment GCDRA
We propose a direct crosswalk to
HCPCS Code G0136 (Administration of
a standardized, evidence-based SDOH
assessment, 5–15 minutes, not more
often than every 6 months), with a work
RVU of 0.18 as we believe this service
reflects the resource costs associated
when the billing practitioner performs
the service described. HCPCS code
G0136 has an intra-service time of 15
minutes, and the physician work is of
similar intensity to proposed HCPCS
code GCDRA. Therefore, we are
proposing a work time of 15 minutes for
HCPCS code GCDRA based on this same
crosswalk to G0136. We are also
proposing to use this crosswalk to
establish the direct PE inputs for HCPCS
code GCDRA.
We are seeking comments on these
proposals.
c. Atherosclerotic Cardiovascular
Disease Risk Management Services
(GCDRM)
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 healthcare professionals,
especially in the context of evolving
changes in medical practice using
evidence-based models of care, such as
the Million Hearts® model. We are
proposing to establish a G-code to
describe ASCVD risk management
services that incorporate the ‘‘ABCS’’ of
CVD risk reduction (aspirin, blood
pressure management, cholesterol
management, and smoking cessation) for
beneficiaries at medium or high risk for
ASCVD (>15 percent in the next 10
years) as previously identified through
an ASCVD risk assessment. We believe
that ASCVD risk management services
include continuous care and
coordination to reduce or eliminate
further elevation of ASCVD risk over
time, and potentially prevent the
development of future cardiovascular
disease diagnoses or first-time heart
attacks or strokes.
We are proposing new G-code,
GCDRM, Atherosclerotic Cardiovascular
Disease (ASCVD) risk management
services with the following required
elements: patient is without a current
diagnosis of ASCVD, but is determined
to be at medium or high risk for CVD
(>15 percent in the next 10 years) as
previously determined by the ASCVD
risk assessment; ASCVD-Specific care
plan established, implemented, revised,
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or monitored that addresses risk factors
and risk enhancers and must
incorporate shared decision-making
between the practitioner and the
patient; clinical staff time directed by
physician or other qualified health care
professional; per calendar month.
Atherosclerotic Cardiovascular Disease
(ASCVD) risk management services refer
to the development, implementation,
and monitoring of individualized care
plans for reducing cardiovascular risk,
including shared decision-making and
the use of the ABCS of cardiovascular
risk reduction, as well as counseling
and monitoring to improve diet and
exercise. We propose that the elements
of the Atherosclerotic Cardiovascular
Disease (ASCVD) risk management
service would include:
• ASCVD Specific Risk Management,
which may include:
++ Promoting receipt of preventive
services (including tobacco
cessation counseling, diabetes
screening, diabetes selfmanagement training)
++ Medication management
(including aspirin or statins to
maintain or decrease risk of CVD)
++ Ongoing communication and care
coordination via certified electronic
health record (EHR) technology
—Synchronous, non-face-to-face
communication methods must be
offered
• ASCVD-Specific, Individualized,
Electronic Care Plan
++ Must address modifiable risk
factors and risk enhancers specific
to CVD, as applicable, such as:
—blood pressure and cholesterol
control
—smoking, alcohol, and other drug
use status, history, and cessation
—physical activity and nutrition
—obesity
++ Plan must be established,
implemented, and monitored and
must incorporate shared decisionmaking between the practitioner
and the patient
Although there is no minimum
service time requirement for ASCVD
risk management services in a month,
each of the proposed elements must be
addressed to bill for the service, unless
a particular element is not medically
indicated or necessary at that time for
that specific patient. For example, the
element of smoking cessation would not
be addressed for a patient who does not
use tobacco. Documentation of each
service element in the patient’s medical
record is required.
Physicians and non-physician
practitioners (NPPs) who can furnish E/
M services could bill for ASCVD risk
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management services. We anticipate
that ASCVD risk management services
would ordinarily be provided by
clinical staff incident to the professional
services of the billing practitioner in
accordance with our regulation at
§ 410.26. We are proposing that ASCVD
risk management services would be
considered a ‘‘designated care
management service’’ under
§ 410.26(b)(5) and, as such, could be
provided by auxiliary personnel under
the general supervision of the billing
practitioner.
We are proposing that patient consent
must be obtained before starting ASCVD
risk management services. Like other
care management services, ASCVD risk
management services would typically be
provided by clinical staff outside of
face-to-face patient visits. Consent can
be written or verbal and must be
documented in the medical record.
Consent should also include informing
the patient about these services, as well
as potentially applicable Medicare costsharing.
We are proposing that ASCVD risk
management services could be billed no
more often than once per calendar
month, and that payment is limited to
one practitioner per beneficiary per
month. Patients must be determined to
be at medium or high risk for CVD (>15
percent in the next 10 years) as
previously determined by the ASCVD
risk assessment and must not have a
current diagnosis of cardiovascular
disease or have a history of heart attack
or stroke.
We are seeking comments on each of
these proposals.
(1) Proposed Valuation for ASCVD Risk
Management Services (GCDRM)
We propose a direct crosswalk to 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), with a work RVU of 0.18
as we believe this service reflects the
resource costs associated when the
billing practitioner performs HCPCS
code GCDRM. CPT code 99211 has a
physician intraservice time of 5
minutes, and the physician work is of
similar intensity to our proposed
HCPCS code GCDRM. Therefore, we are
proposing a work time of 5 minutes for
HCPCS code GCDRM based on this
same crosswalk to CPT 99211. We are
also proposing to use this crosswalk to
establish the direct PE inputs for HCPCS
code GCDRM, with modifications to
reflect non-face-to-face services. These
modifications include eliminating PE
inputs used in face-to-face services such
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as preparing and cleaning the room. We
are seeking comments on these
proposals.
5. Strategies for Improving Global
Surgery Payment Accuracy
a. Background
Currently, there are approximately
4,100 physicians’ services that are
coded and valued under the PFS as
global surgical packages (herein ‘‘global
packages’’). Global packages are single
codes that are valued to include all
services provided during a specified
period of days (0-day, 10-day, or 90-day
global packages) by a physician (or
another practitioner in the same group
practice (as defined at 42 CFR 411.352))
for a specific surgical procedure. The
Medicare Physician Fee Schedule
(MPFS) look-up tool provides
information on each procedure code,
including the global surgery indicator.
This tool is available at https://
www.cms.gov/medicare/physician-feeschedule/search/overview.
The global packages include:
• The surgical procedure itself,
including day-of pre-service activities
and day-of recovery care;
• Post-operative evaluation and
management (E/M) visits and discharge
services provided during specified postoperative periods (10- or 90-day periods
for most minor and major procedures,
respectively; 0-day global packages do
not include post-operative visits);
• Pre-operative visits on the day of
the procedure (for services with 10- and
90-day periods) and pre-operative visits
on the day prior to the procedure (for
major procedures with 90-day periods
only);
• Services provided during the postoperative period (for services with 10and 90-day periods) related to the
procedure (for example, treatment of
complications, pain management).
Any medical care that requires a
return to the operating room during the
global period is paid separately and
starts a new global period. Like other
services paid under the PFS, postoperative visits that are part of the
global packages can vary by level and
site of service. Global packages,
including the pre-operative, day-of, and
post-operative visits associated with the
surgical procedure, are valued using our
annual PFS rulemaking process.
As we discussed in the CY 2015 PFS
final rule, we have identified and
articulated several concerns with the
global packages related to the accuracy
of valuation and payment under the
PFS. Foremost, we have longstanding
concerns regarding whether the
packages are valued based on estimates
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consistent with the number and kind of
services actually being furnished.
Findings from multiple OIG reports
suggest that practitioners perform fewer
post-operative visits than are expected
and accounted for in the valuation of
the global packages. We provided a
detailed discussion of these concerns in
the CY 2015 PFS final rule (79 FR 67582
through 67591). Similarly, we described
concerns that global packages as
currently constructed may cause
potential distortions in valuation among
PFS services, and that the structure of
the current packages assumes a single
model of care delivery (a single
practitioner or other practitioners in the
same group practice furnishing the
surgical procedure and all associated
care) and does not appropriately address
scenarios where the surgical procedure
and follow-up care are provided by
different practitioners in different group
practices. Taking these findings and
concerns into account, we finalized a
policy to transition all 10-day and 90day global packages to 0-day global
packages, which would allow any postoperative visits furnished after the day
of the procedure to be billed separately
as standalone visits by any practitioner
who furnishes them. However, in 2015,
through amendments made by section
523 of the Medicare Access and CHIP
Reauthorization Act of 2015 (MACRA;
Pub. L. 114–10, enacted April 16, 2015),
we were prohibited under section
1848(c)(8)(A) of the Act from
implementing this finalized policy.
Further, under section 1848(c)(8)(B), we
were required to collect data beginning
in 2017 on the number and level of postoperative visits typically provided to
patients during 10- and 90-day global
periods and to use this newly collected
data and other data beginning in 2019
to improve the accuracy of global
package valuation.
In response to these requirements,
over the past 9 years, we have:
• Initiated research contracts and
implemented a data-collection process
to analyze data to understand the extent
to which post-operative visits are
furnished to patients and improve the
accuracy of payment rates for the global
surgical packages. This research
contract was funded by CMS (HHSM–
500–2014–00036I) and carried out
within the Payment, Cost, and Coverage
Program in RAND Health Care.
• Released three reports (located at
https://www.cms.gov/medicare/
payment/fee-schedules/physician/
global-surgery-data-collection) on the
number of E/M visits furnished during
post-operative periods, the most recent
finding that only 4 percent of expected
post-operative visits in 10-day global
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packages and 38 percent of expected
post-operative visits following 90-day
global packages were furnished to
patients.
• Fielded and released a report on a
survey of selected global packages,
collecting information related to the
level and complexity of medical visits
furnished during post-operative periods.
This research contract was funded by
CMS (HHSM–500–2014–00036I) and
carried out within the Payment, Cost,
and Coverage Program in RAND Health
Care.
• Released two reports on potential
approaches for revaluing the global
packages based on these findings.
• Analyzed the prevalence of transfer
of care modifiers (–54 for surgical care
only; –55 for post-operative
management only; and –56 preoperative management only) applied to
global packages.
More recently, in the CY 2023 PFS
proposed and final rules, we reviewed
the prior work and conversations
around the accuracy of global package
valuations and solicited comments from
the public on (1) suggested strategies for
revaluing these services, (2) information
on how changes to healthcare delivery
and payment may be impacting the
relevance or accuracy of global package
payments, and (3) possible impact of
changes to global packages on health
care access for beneficiaries (see 87 FR
69432 through 69437). In response to
the comment solicitation in the CY 2023
PFS proposed rule, some commenters
generally disagreed with our findings
that the post-operative visits in the
global packages are not performed as
frequently as assumed in our valuation
of global surgical packages. However,
opposition from commenters was based
on anecdotal assertions rather than
alternative data. Many of these
commenters’ specific points restated
earlier comments submitted in response
to our request for feedback in the CY
2020 PFS proposed rule on claims-based
reporting of post-operative visits, survey
findings on the level of visits, and
potential revaluation approaches. Some
commenters supported eliminating 10day global package periods and
requested that the AMA RUC review
these services. However, these
commenters also acknowledged that the
AMA RUC review process could take
years. In addition to the comments we
received in response to the CY 2023 PFS
proposed rule, we have received
feedback over several years from many
interested parties regarding the findings
from claims-based reporting of postoperative visits and considered
revaluation methodologies presented in
our prior reports.
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Overall, we have continued exploring
ways to improve the accuracy of
valuation and payment for global
packages to ensure appropriate
payments to the practitioners providing
pre-operative, surgery, and postoperative care to Medicare beneficiaries
while considering feedback from
interested parties. In addition,
commenters have not proposed specific
alternative strategies to revalue global
surgical packages.
Separately, we continue to review
approaches to better describe
physicians’ services in the context of the
evolving care delivery landscape and to
allow practitioners to furnish patientcentered care. Our review work includes
considering care delivery models
discussed with interested parties (and
developed though our CMS Innovation
Center work), reviewing our policies
and billing requirements, identifying
care elements that could serve as the
building blocks for describing newer,
impactful services, and seeking
opportunities to reduce administrative
burdens for practitioners while ensuring
accurate payment. Through this lens, we
have also recently reviewed our billing
requirements and payment policies for
the global packages, concurrent with
continued analysis of the Medicare
claims data.
While ongoing, our review highlights
opportunities for us to clarify or revise
longstanding policy and billing
instructions for global packages, using
data and experience gathered over the
last several years, consistent with our
overall objectives to pay more
accurately for services and to right-size
the valuation of PFS services based on
how practitioners currently furnish
these services. In this proposed rule, we
discuss proposals (1) to revise our
transfer of care policy for global
packages to address instances where one
practitioner furnishes the surgical
procedure and another practitioner
furnishes related post-operative E/M
visits during the global period, and (2)
to develop a new add-on code that
would account for resources involved in
post-operative care provided by a
practitioner who did not furnish the
surgical procedure. We believe that
addressing the use of transfer of care
modifiers, and the resources involved
when practitioners who do not furnish
the surgical procedure provide postoperative care, are essential steps in
aligning payment with the way in which
surgical procedures are currently
furnished as evidenced in our data, and
would make meaningful progress
toward more accurate payment for these
services in particular and improve
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relative valuation for PFS services
overall.
b. Clarifying the Scope of Global
Surgical Packages
We have valued global packages to
include the surgical procedure and
services furnished during the specified
global period related to the surgical
procedure when furnished by the
practitioner who performs the surgery
(hereafter in this section, the
proceduralist) or by another practitioner
in the same group practice as the
proceduralist.
Under current Medicare payment
policy, certain services furnished during
the global period by the proceduralist or
by another practitioner in the same
group practice may be separately billed
with an appropriate modifier:
• Initial decision for surgery: E/M
service billed with modifier –57
(Decision for Surgery).
• E/M services unrelated to the
procedure: billed with modifier –24
(Unrelated E/M Service During a Global
Period).
• Other services unrelated to the
procedure (including underlying
condition treatment, diagnostic tests,
distinct procedures) not including care
for complications/returns to the
operating room: no modifier required.
• Failure of a less extensive
procedure requiring a more extensive
procedure: no modifier required.
• Organ transplant
immunosuppressive therapy: no
modifier required.
• Critical care services unrelated to
surgery: billed with modifier –FT if in
the post-operative period.
In general, except where a formal
transfer of care modifier applies, a
practitioner other than the proceduralist
or a practitioner in the same group
practice as the proceduralist can bill
separately for an E/M visit for services
they furnish during the global period for
a global package, including postoperative E/M visits related to the
procedure. We established formal
transfer of care modifiers to apply in
cases where the work, time, and
resources involved in furnishing
services included in the global packages
are split between the proceduralist (or
another practitioner in the same group
practice) and other practitioners
providing related post-operative visits
during the global period. Under our
current transfer of care policy, transfer
of care modifiers must be reported when
a formal transfer of care arrangement is
documented by both the proceduralist
and another practitioner providing the
related post-operative visits. Based on
our analysis of Medicare fee-for-service
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claims data, these formal transfer of care
modifiers are rarely used and, when
they are, it is often with respect to
certain ophthalmologic procedures (for
example, cataract surgery).
Based on our analysis of claims data,
we believe that it may be helpful to
review our current policy regarding the
applicability of transfer of care
modifiers for the medical and billing
communities. Under our current policy,
the scope of the global package extends
to services furnished by the entire group
practice of the proceduralist, including
services furnished by practitioners in
the group practice who are a different
specialty from the proceduralist. In
other words, the PFS payment for postoperative visits and other services
furnished during the global period that
are related to the surgical procedure and
provided by the proceduralist or a
practitioner in the same group practice
as the proceduralist is bundled into the
global package, and those services are
not separately billable. If the
proceduralist or a practitioner in the
same group practice as the proceduralist
wants to bill during the global period for
a service furnished to the surgical
patient, but unrelated to the global
package, the correct modifier must be
used to indicate that the service is not
related to the global package. Without a
modifier to indicate otherwise, during
the global period for a global package,
all E/M services furnished to the patient
by the proceduralist or another
practitioner in the same group practice
as the proceduralist are presumed to be
related to, and included in the payment
for, the global package. Modifiers for
separate payment (such as modifier -24)
are required when services unrelated to
the global package are billed by the
proceduralist or a practitioner in the
same group practice as the proceduralist
during the global period.
c. Strategies To Address Global Package
Valuation
We recognize that we are precluded
under section 1848(c)(8)(A) of the Act
from revisiting the policy we
established in the CY 2015 PFS final
rule to revalue all 10-day and 90-day
global packages to 0-day global packages
(79 FR 67582–67591). Further, we note
that transitioning all global packages to
0-day global periods could take several
years and require substantial CMS
resources (see CY 2014 PFS final rule
(77 FR 44737 through 44738) for
previous discussion). We have also
considered revaluing 10-day and 90-day
global packages to reflect the observed
number of post-operative visits
furnished to patients based on data we
have collected over nearly a decade and
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note that this approach would be
quicker to implement, assuming there
would be straightforward ways to
revalue the services with the data.
However, interested parties have
continued to express uncertainty about
the validity of claims-based counts of
post-operative visits. This uncertainty
stems primarily from CMS not having
complete information surrounding the
use of the transfer of care modifiers
since they are not currently routinely
used. The same interested parties also
object conceptually to revaluing the 10day and 90-day global packages using
the ‘‘building block’’ framework, where
each component of a service, including
bundled post-operative visits,
contributes to total valuation to align
valuation with the number of postoperative visits typically provided to
patients. Some interested parties have
expressed larger concerns about the
redistributive impacts across the PFS
among specialties if we were to
implement and revalue all global
packages.
We acknowledge the practical
challenges involved in revaluing 10-day
and 90-day global packages, whether
they remain as 10-day and 90-day
periods with fewer post-operative visits
or are transitioned to 0-day global
packages, and continue to carefully
consider how to best improve global
package valuation given access to
administrative claims data and other
inputs that help us understand the
scope of services provided to patients
within global packages. Ultimately, we
want to ensure payments to
practitioners and the relative values
assigned to global surgical packages are
accurate and, to the extent possible,
driven by real-world objective and
updatable information regarding the
relative resources involved in furnishing
the services.
For CY 2025, we are focused on
different aspects of our policy objectives
for global packages and propose the
following policies, which are not
mutually exclusive, to obtain
information and allow for more accurate
payment to reflect time and resources
spent on post-operative care associated
with the current global packages. We
will continue to assess and monitor for
potential future opportunities to
improve our payment approach for the
global packages more broadly.
Additionally, in developing our
proposed policies to pay more
accurately for the global packages, we
also considered whether, when, or how
our policies may be affected when
services are provided by the
proceduralist, versus another
practitioner who did not perform the
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procedure but is providing follow up
care. We also recognize that there may
be multiple practitioners in the same or
different specialties in the same group
practice and considered how our
policies should apply to practitioners in
a range of specialties within the same
group practice. We are seeking comment
on these considerations in the context of
our proposed policies and welcome
feedback that may further inform our
payment policy for global packages.
Additionally, as we continue to better
understand what services are being
furnished in the global period, by
whom, and how the global surgical
packages are valued and billed, we are
seeking comment on how remote
monitoring and other types of new
technologies represent new resource
costs and/or produce efficiencies and
effectiveness of post-operative care. This
information could be useful both for
purposes of valuation for surgical and
post-operative care, as well as for
policies regarding when specific PFS
codes should be reported during global
periods for global packages.
d. Expand Applicability of Transfer of
Care Modifiers
We created transfer of care payment
modifiers at the inception of the PFS.
Under our current policy, these
modifiers are required to be appended
to the relevant global package code
when billing for services that are within
the scope of the global package (within
the global period and related to the
surgical procedure) only when the
proceduralist and one or more other
practitioners who are not in the same
group practice as the proceduralist
formally document their agreement to
provide distinct portions of the global
package.
The following transfer of care
modifiers describe the different portions
of the global surgical package that could
be provided by different practitioners:
• Modifier –54 Surgical Care Only:
this modifier is appended to the
relevant global package code to indicate
that the proceduralist performed only
the surgical procedure portion of the
global package.
• Modifier –55 Post-operative
Management Only: this modifier is
appended to the relevant global package
code to indicate that the practitioner
performed only the post-operative
management portion of the global
package.
• Modifier –56 Pre-operative
Management Only: this modifier is
appended to the relevant global package
code to indicate that the practitioner
performed only the pre-operative
portion of the global package.
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For each of these modifiers, the
payment for the global package is
adjusted based on the applicable
percentage noted in the PFS Relative
Value files (https://www.cms.gov/
medicare/payment/fee-schedules/
physician/pfs-relative-value-files).
As previously noted, we currently
require the transfer of care modifiers (–
56 pre-operative care, –54 for
procedures, and –55 for post-operative
care) to be appended in cases where
there is a formal documented transfer of
care agreement, that is, ‘‘in the form of
a letter or an annotation in the discharge
summary, hospital record, or
Ambulatory Surgical Center (ASC)
record’’ (CMS Manual System, Pub 100–
04 Medicare Claims Processing,
Transmittal 11287). In our recent
analyses of 2022 Medicare claims data,
we identified that these modifiers were
rarely used other than for certain
ophthalmology global packages. We
found over 99 percent of claim lines for
90-day surgical procedures billed with
modifier –54 were ophthalmology
services (primarily cataract-related
procedures). We also identified a
difference in the number of claim lines
annually for a given 90-day global
package with modifier –54 and with
modifier –55. In other words, there are
sometimes more claim lines billed with
modifier –54 than there are
corresponding lines with modifier –55
and vice versa during a year. We note
that modifier –56 (pre-operative
management only) is only very rarely
used in practice. These recent
observations suggest (1) the
overwhelming concentration of reported
transfer of care modifiers is in
ophthalmology procedures, and (2) a
potential mismatch in billing for formal
transfer of care cases between
proceduralists and other practitioners
providing post-operative care.
While we recognize the benefits to
continuity of care when the
proceduralist also provides preoperative and follow-up care for the
procedure, we also recognize that it is
not always feasible, or even perhaps
typical practice for the same practitioner
to furnish all portions of the global
package; for example, in instances when
the practitioner furnishing the
procedure does not schedule a postoperative visit(s) on the day of the
procedure or plans for the patient to
follow up with their primary care
provider, or when the practitioner
performing the surgery arranges
alternative follow-up care because it
would be difficult for the beneficiary to
travel to return for follow-up care.
Because our current policies require use
of the transfer of care modifiers only
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where there is a formal documented
agreement between practitioners to
provide specific portions of the global
package, we believe there are many
practical and potentially common
circumstances under which the transfer
of care modifiers would not be required
or used.
Beginning for services furnished in
2025, we are proposing to broaden the
applicability of the transfer of care
modifiers for the 90-day global
packages. We are proposing to require
the use of the appropriate transfer of
care modifier (modifier –54, –55, or –56)
for all 90-day global surgical packages in
any case when a practitioner plans to
furnish only a portion of a global
package (including but not limited to
when there is a formal, documented
transfer of care as under current policy,
or an informal, non-documented but
expected, transfer of care). Practitioners
billing for a global package procedure
code with modifier –54 and other
practitioners in the same group practice
as that practitioner would still be able
to bill during the global period for any
separately identifiable E/M services they
furnish to the patient that are unrelated
to the global package procedure. To do
so, the practitioner would append
modifier –24 to the claim line for the E/
M service.
This proposed policy, which would
be a first step toward improved
valuation and payment while retaining
the fundamental structure of the global
packages, would provide us with more
accurate information on the resources
involved in furnishing components of
global surgical packages. This proposal
would prevent duplicative Medicare
payment for post-operative care because
the global surgical package payment
would be adjusted based on the
appended modifier, and payment for
post-operative care would not be made
both as part of a global surgical package
and through separately billed E/M
visits. We also anticipate that the
proposed policy would provide us with
insight into changes in standards of
practice and post-operative patient care
for services that are not billed with
transfer of care modifiers pursuant to
our current policy (that is, services other
than certain ophthalmology
procedures).
We acknowledge the potential
challenge associated with anticipating
whether other practitioners will furnish
portions of the global package and,
accordingly, appending the appropriate
modifier when billing global package
services.
We are interested in understanding
and are seeking comment on the
circumstances under which
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61733
practitioners in separate group practices
furnish different portions of the care
included in global packages, and what
that means for reporting the transfer of
care modifiers. While we are making
proposals related to the 90-day global
periods beginning for services furnished
in 2025, we are also seeking comment
on whether we should consider
proposing these changes for the 10-day
global packages in future rulemaking.
e. Payment for Global Packages
Under our current policy for global
packages where the transfer of care
modifiers are used (required only where
there is a formal transfer of care
arrangement), the total combined PFS
payment made for the global package
during the global period does not
exceed the total global surgical package
payment established for the procedure
when billed without any transfer of care
modifier. In general, we continue to
believe this is the appropriate result
when more than one practitioner
furnishes portions of a global package.
Under our proposal, we would require
that practitioners performing the
surgical procedure but not intending to
furnish the post-operative portions of a
90-day global service would
appropriately append the –54 modifier
that we have previously discussed,
which would adjust the portion of
payment received to accurately reflect
the service furnished.
More specifically, as noted in the
discussion above, the transfer of care
modifiers correspond to three distinct
portions of the global package (preoperative services, the surgical
procedure itself, and post-operative
care). We have assigned a proportion of
the global package payment to each
portion of the service based on
longstanding assumptions. Under our
current policy, the payment for the
entire global package is paid to the
billing practitioner unless a transfer of
care modifier is included on the claim.
Payment is only adjusted if a transfer of
care modifier is included on the claim.
We are requesting comments, as we
further develop our payment policies for
global packages, on how best to
determine the appropriate payment
proportions for the three portions of the
global package, which impact payment
to the different practitioners who
furnish the different portions of the
service.
We are continuing to consider
approaches to establishing the payment
allocations for portions of the global
package when the transfer of care
modifiers are used, and anticipate
revising the allocations through future
rulemaking. We are seeking comment on
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potential approaches to revise these
payment allocations and how they
could be established to better reflect
current medical practice and
conventions for post-operative followup care. We seek to identify a
procedure-specific, data-driven method
for assigning shares to portions of the
global package payment to more
appropriately reflect the resources
involved in each portion. We would
appreciate and carefully consider
recommendations from interested
parties, including the AMA RUC, on
what those allocation percentages
should be, based on how the global
package codes are valued and any other
relevant information.
We have contracted with RAND to
support data collection and analysis in
the past and, as identified in RAND’s
prior reports and described in detail, we
surmise that the policy to apportion and
pay for the three portions of the global
package based on the presence of
transfer of care modifiers does not
always work smoothly. In considering
RAND’s reports, one reason for this is
that fewer post-operative visits are
provided to patients compared to the
number of visits reflected in the
valuation of global packages. The global
packages reflect a certain number of
post operative visits (noted in the
Physician Time File) that typically
occur during the post-operative global
period. However, there is no easy way
within a global package to separate the
RVUs for the procedure itself from the
RVUs for post-operative visits that are
not typically provided to patients. If our
allocation of the global package
payment based on the presence of
transfer of care modifiers were to
undervalue the surgical procedure
portion or the post-operative care
portion of the global package, we are
concerned that we could
unintentionally introduce incentives
that influence current medical practice
for transfers of care. This gets at RAND’s
prior recommendation that we revalue
global packages to reflect the actual
number of post-operative visits
provided to patients. After revaluation,
separating the procedure and postoperative payments would reflect
observed data and mitigate any possible
inappropriate incentives in place for
practitioners to initiate transfers of care
and support use of transfer of care
modifiers as medically appropriate. This
approach has the advantage of
anchoring the valuation of separate –54
and –55 components using real-world
information on post-operative visits
reported to CMS rather than on
historical assumptions or current survey
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data reflecting estimates of the typical
number and level of visits.
In our internal review of the
percentages assigned for the preoperative, surgical care, and postoperative portions of the global package,
we found that there are a small number
of codes that do not have any assigned
percentages in our files even though
these codes are identified as global
packages. HCPCS codes 77750 (Infusion
or instillation of radioelement solution
(includes 3-month follow-up care)),
HCPCS code 77761 (Intracavitary
radiation source applic simple), HCPCS
code 77762 (Intracavitary radiation
source applic intermed), and HCPCS
code 77763 (Intracavitary radiation
source applic complex) do not have
assigned percentages in our RVU files.
It is our understanding, however, that
the MACs have local edits in place to
ensure appropriate payment for these
services when billed with the transfer of
care modifiers. We are seeking comment
on whether we should consider, first,
whether these codes are appropriately
categorized as 90-day global package
codes. If these are appropriately
considered to be 90-day global package
codes, we are seeking comment on what
the assigned percentages should be for
the pre-operative, surgical care, and
post-operative portions of the service.
f. Post-Operative Care Services Add-On
Code
We recognize the importance of
continuity in surgical and postoperative care. However, we recognize
that there are instances where postoperative care is not furnished by the
proceduralist or another practitioner in
the same group practice, or even by a
practitioner who is in the same specialty
as the proceduralist, despite there being
no formal transfer of care. We also
recognize that there is an extra level of
complexity involved when a
practitioner sees a patient postoperatively after a surgical procedure
performed by another practitioner in
those circumstances. The practitioner
providing the post-operative care may
not be involved in creating the surgical
plan, and may not have access to the
operative notes to know how the surgery
went or be abreast of any particular
considerations related to the procedure
that may factor in medical care
decisions for the post-operative care. As
such, we recognize that there are
comparatively more resource costs
incurred when a practitioner who did
not furnish the surgical procedure in a
global package provides the follow-up
care. We are proposing to address these
scenarios, which can occur in a few
different ways, by establishing a new
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add-on code that would account for
resources involved in post-operative
care for a global package provided by a
practitioner who did not furnish the
surgical procedure and does not have
the benefit of a formal transfer of care.
However, we note that when a patient
is seen by practitioners in the same
group practice or specialty as the
surgeon, the same resources are not
incurred during follow-up and
therefore, the add-on code should not be
billed by another practitioner in the
same group practice as the practitioner
who performed the surgical procedure,
or in the same specialty as the
practitioner who performed the surgical
procedure. In the case of a practitioner
providing follow up care who is of a
different specialty and not within the
same group practice as the
proceduralist, researching the procedure
to determine expected post-operative
course and potential complications may
be needed, which would warrant using
the add-on code. We also acknowledge
that sometimes the proceduralist does
not schedule the patient to follow up
with them post-operatively and directs
the patient to follow up with other
practitioners as needed, such as with
the patient’s primary care provider. The
patient may independently choose to
follow up with their primary care
provider or another practitioner based
on other considerations such as
convenience of the practice location or
ease of scheduling. We understand and
acknowledge that the patient can choose
to see another practitioner without the
knowledge of the practitioner who
performed the procedure.
To more appropriately reflect the time
and resources involved in these kinds of
visits, we are proposing to make
payment using a new add-on code to be
billed with an office/outpatient E/M
visit for post-operative follow-up care
during the global period of a global
package to capture additional resources
associated with practitioners who were
not involved in furnishing the surgical
procedure. This follow-up care may
include, but is not limited to, obtaining
and reviewing the surgical notes and
surgical history, monitoring for signs
and symptoms of infection, taking into
account any considerations from the
surgical procedure that may affect the
medical care, and monitoring for any
potential post-operative complications
that may arise. It is often difficult in
these circumstances for the practitioner
who did not perform the surgical
procedure to know how the wound
looked after the procedure, and so it is
more challenging to recognize possible
changes that may have occurred since
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the time of the procedure (when this is
something the operating surgeon would
have been able to know). This new code
would be billed by the practitioner who
furnishes the post-operative office/
outpatient E/M visits when that
practitioner is not the proceduralist and
is not in the same specialty or group
practice as the proceduralist.
Documentation in the medical record
must justify use of the add-on code and
that the E/M visit was, as clinically
understood by the reporting
practitioner, related to a post-operative
visit furnished during the 90-day post
operative period. As noted earlier, we
are proposing to expand the required
use of the transfer of care modifiers as
a first step toward improving payment
for the global packages to promote
improved valuation and payment for
these services. Instituting an add-on
code to capture the time and intensity
of post-operative work absent a formal
transfer of care, would be an essential
step in recognizing how the services are
currently furnished and make
meaningful progress toward ‘rightsizing’ the structure of the global
packages.
Given the history of the global
packages since data collection began, as
specified in section 1848(c)(8) of the
Act, and in consideration of our policies
for post-operative care and our proposal
requiring the use of the transfer of care
modifiers in a broader set of
circumstances, we believe that the
timing is appropriate to establish an
add-on code and payment for postoperative care provided in the office/
outpatient setting by a practitioner other
than the proceduralist (or another
practitioner in the same specialty) to
account for the additional time,
intensity, and resources that are
involved in post-operative care. We are
proposing a new HCPCS code, GPOC1,
to capture the additional time and
resources spent in providing follow up
post-operative care by a practitioner
who did not perform the surgical
procedure and who has not been
involved in a formal transfer of care
agreement.
We propose the following code and
descriptor for the proposed add-on
code: GPOC1 (Post-operative follow-up
visit complexity inherent to evaluation
and management services addressing
surgical procedure(s), provided by a
physician or qualified health care
professional who is not the practitioner
who performed the procedure (or in the
same group practice), and is of a
different specialty than the practitioner
who performed the procedure, within
the 090-day global period of the
procedure(s), once per 090-day global
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period, when there has not been a
formal transfer of care and requires the
following required elements, when
possible and applicable:
• Reading available surgical note to
understand the relative success of the
procedure, the anatomy that was
affected, and potential complications
that could have arisen due to the unique
circumstances of the patient’s operation.
• Research the procedure to
determine expected post-operative
course and potential complications (in
the case of doing a post-op for a
procedure outside the specialty).
• Evaluate and physically examine
the patient to determine whether the
post-operative course is progressing
appropriately.
• Communicate with the practitioner
who performed the procedure if any
questions or concerns arise. (List
separately in addition to office/
outpatient evaluation and management
visit, new or established)).
We are proposing that HCPCS code
GPOC1 would be reported by a
physician or other practitioner who did
not perform the surgical procedure for a
global package and provides related
post-operative visits during the global
period despite the absence of a formal
transfer of care. We are proposing that
the add-on code (HCPCS code GPOC1)
would only be reported with an office
or other outpatient E/M visit for the
evaluation and management of a new or
established patient. We would expect
the documentation in the medical
record to indicate the relevant surgical
procedure, to the extent the billing
practitioner can readily identify it, in
order to aid in our understanding of the
post-operative care being furnished and
when there is no transfer of care
modifier appended on the claim.
We are proposing that this code could
be billed only once during the 90-day
global period for the global package
because we believe the practitioner
would only have additional resource
costs upon the first visit following the
procedure. We are proposing to assign a
ZZZ global period payment indicator for
HCPCS code GPOC1, as this allows the
add-on code to be billed during the
post-operative time frame that applies to
payment for each surgical procedure
and, under our proposed policy, this
code would be reportable with an E/M
visit. The ZZZ global period payment
indicator would identify this code as a
service that is related to another service
paid under the PFS and is always
included in the global period of the
other service.
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61735
g. Proposed Valuation for GPOC1 AddOn Code
We note that the proposed valuation
of HCPCS code GPOC1 is meant to
capture the additional resource costs,
including for visit complexity inherent
to office/outpatient care associated with
a post-operative visit that is not
accounted for in the appropriate office/
outpatient E/M base code billed by the
physician or practitioner. Therefore, we
believe that CPT code 90785 (Interactive
complexity (List separately in addition
to the code for primary procedure))
serves as an appropriate reference for
the purposes of valuing HCPCS code
GPOC1. CPT code 90785 was created to
capture additional work that occurs
during diagnostic psychiatric
evaluation, psychotherapy,
psychotherapy performed with an E/M
service and group psychotherapy
sessions, and the service refers to
specific communication factors that
complicate the delivery of a psychiatric/
psychotherapy procedure. However, we
believe there may be relatively less work
involved for GPOC1 when compared to
the work of CPT code 90785,
considering the amount of time needed
to gather the operative history and
conduct the elements discussed above.
Therefore, we are proposing a work
RVU of 0.16, which represents
approximately half of the assigned work
for minutes of CPT code 90785.
Additionally, we are proposing a work
time of 5.5 minutes (or half of the 11
minutes established for CPT code
90785), personally performed by the
billing practitioner including the
elements discussed above during the
post-operative E/M visit furnished
during the global period, that is, no later
than 90-days following a 90-day global
code, respectively. CPT code 90785 has
no direct PE inputs, and we are
proposing the same for HCPCS code
GPOC1.
To help inform whether our proposed
valuation reflects the typical service, we
are seeking comment the typical time
and intensity physicians and
practitioners spend over and above a
separately billed E/M visit when
providing post-operative care to a
patient when they did not perform the
surgical procedure, gathering the
surgical history as well as the preoperative, intra-operative, and postoperative, and on the proposed service
elements and the relative intensity
compared to similar service elements of
other CPT codes. For the individual
practitioner, not having an intimate
knowledge of the procedure itself and
not having a before/after comparison to
look at for the wound can all complicate
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their E/M visit. The proposed work
RVUs are intended to account for the
additional relative resource costs in
time and intensity in addition to those
involved in the E/M visit.
Finally, we recognize that historically,
the CPT Editorial Panel has frequently
created CPT codes describing services
for which we originally established Gcodes and adopted them through the
CPT Editorial Panel process. We note
that we would consider using any newly
available CPT coding to describe
services similar to those described here
in future rulemaking.
For discussion of our expected
utilization assumptions for this service,
see the discussion in the Regulatory
Impact Analysis section of this
proposed rule.
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H. Supervision of Outpatient Therapy
Services in Private Practices,
Certification of Therapy Plans of Care
With a Physician or NPP Order, and KX
Modifier Thresholds
1. Supervision of Outpatient Therapy
Services in Private Practices
In the CY 2024 PFS final rule, we
finalized our proposal to allow remote
therapeutic monitoring (RTM) services
to be furnished by occupational therapy
assistants (OTAs) and physical therapy
assistants (PTAs) under the general
supervision of occupational therapists
(OTs) and physical therapists (PTs) in
private practice, in an effort to align
with the general supervision policy for
these services for physicians and other
practitioners described in the CY 2023
final rule (88 FR 78990). We also noted
that we would consider for possible
future rulemaking the commenters’
responses to our request for information
(RFI) on changing the supervision of
therapy assistants in the private practice
setting to general supervision for all
therapy services (88 FR 78990 through
78992).
In the CY 2024 PFS proposed rule, we
reviewed the statutory provisions at
sections 1861(p) and 1861(g) (by crossreference to section 1861(p)) of the Act
that describe outpatient physical
therapy and occupational therapy
services furnished to individuals by
physical therapists (PTs) and
occupational therapists (OTs) meeting
licensing and other standards prescribed
by the Secretary if the services meet the
necessary conditions for health and
safety. These statutory provisions refer
separately to outpatient therapy services
furnished by a provider of services
(such as a rehabilitation agency) and
those services furnished in the
therapist’s office or the individual’s
home, thus distinguishing therapists
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who work for an institutional provider
of therapy services from therapists who
furnish and bill independently for these
outpatient therapy services (88 FR
52358 through 52359). In regulations,
we have addressed these therapists as
physical or occupational therapists in
private practice (PTPPs and OTPPs) (63
FR 58868 through 58870). The
regulations specific to services
furnished by occupational or physical
therapists in private practice are found
at §§ 410.59(c) and 410.60(c),
respectively.
We also summarized a history of
related regulatory provisions in the CY
2024 PFS proposed rule. In the CY 2005
PFS final rule with comment period (69
FR 66236, 66351 through 66354), we
explained that the personnel
requirements that are applicable for
Home Health Agencies (HHAs) at 42
CFR part 484 for therapists, therapy
assistants and speech-language
pathologists (SLPs) apply to all
outpatient physical therapy,
occupational therapy, and speechlanguage pathology services. In the CY
2005 PFS final rule, we also added a
basic rule at §§ 410.59(a) and 410.60(a),
respectively, by cross-referencing 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. Later, 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, and SLPs.
In the CY 2024 PFS proposed rule,
through our RFI on general supervision
of OTAs and PTAs by OTPPs and
PTPPs, respectively, we solicited public
comment, along with supporting data,
for our consideration for possible future
rulemaking about the following: (a) the
questions and concerns we highlighted
related to access, patient safety, and
utilization; (b) revising
§§ 410.59(a)(3)(ii) and (c)(2) and
410.60(a)(3)(ii) and (c)(2) to permit
general supervision of OTAs and PTAs
by the OTPP and PTPP, respectively,
when furnishing therapy services; and
(c) any appropriate exceptions to
allowing general supervision in the
furnishing of therapy services (88 FR
52358 through 52359).
In the CY 2024 PFS final rule, we
reviewed the comments we received in
response to the proposed rule (please
refer to (88 FR 78990 through 78992)).
We noted that we would consider these
comments for possible future
rulemaking—see our review of
comments on the RFI in the CY 2024
PFS final rule (88 FR 78992).
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Over the past several years and again
more recently, we have heard from
interested parties that the direct
supervision requirements in the private
practice setting are problematic for
OTPPs and PTPPs who must remain onsite and immediately available when
Medicare patients are treated in order to
bill for therapy services furnished by
their supervised OTAs and PTAs. As a
remedy to this situation, interested
parties have requested that we revise
our requirement for PTPPs and OTPPs
to provide direct supervision of OTAs
and PTAs to align with the general
supervision policies for OTs and PTs
that work in Medicare institutional
settings that provide therapy services
(for example, rehabilitation agencies,
outpatient hospitals, SNFs and
comprehensive outpatient rehabilitation
facilities (CORFs), etc.), to allow for the
general supervision of their therapy
assistants. These interested parties tell
us that their respective State laws and
policies allow general supervision of
therapy assistants (most often requiring
the OT or PT to be in touch with their
therapy assistants via
telecommunication) in at least 44 States
for PTAs,136 and all but one State for
OTAs.
Some interested parties have reported
that allowing for general supervision of
OTAs and PTAs by OTPPs and PTPPs,
respectively, would allow for patients to
have increased access to outpatient
therapy services, even with ongoing
healthcare workforce shortages. The
shortages of OTs 137 and OTAs,138
PTs,139 and PTAs,140 are noted by the
United States Bureau of Labor Statistics,
which shows thousands of open
positions in all of these fields. Interested
parties noted that over 22,000 PTs left
the workforce in 2021.141 Additionally,
136 Federation of State Boards of Physical Therapy
Jurisdiction Licensure Reference Guide https://
www.fsbpt.net/lrg/Home/Supervision
RequirementLevelsBySetting.
137 Bureau of Labor Statistics, U.S. Department of
Labor, Occupational Outlook Handbook,
Occupational Therapists, at https://www.bls.gov/
ooh/healthcare/occupational-therapists.htm
(visited April 17, 2024).
138 Bureau of Labor Statistics, U.S. Department of
Labor, Occupational Outlook Handbook,
Occupational Therapy Assistants and Aides, at
https://www.bls.gov/ooh/healthcare/occupationaltherapy-assistants-and-aides.htm (visited April 17,
2024).
139 Bureau of Labor Statistics, U.S. Department of
Labor, Occupational Outlook Handbook, Physical
Therapists, at https://www.bls.gov/ooh/healthcare/
physical-therapists.htm (visited April 17, 2024).
140 Bureau of Labor Statistics, U.S. Department of
Labor, Occupational Outlook Handbook, Physical
Therapist Assistants and Aides, at https://
www.bls.gov/ooh/healthcare/physical-therapistassistants-and-aides.htm (visited April 17, 2024).
141 See the report by Definitive Healthcare dated
October 2022 at https://www.definitivehc.com/sites/
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these interested parties noted that
workforce shortages have greater impact
on private practices in rural and
underserved areas where hourly wages
are lower, and the OTPPs and PTPPs in
these areas tend to have small practices.
The interested parties stated that
Medicare’s direct supervision policy,
which requires the PTPP and the PTA
to both be present when a Medicare
patient is treated, does not allow small
practices with one PT and one or two
PTAs, for example, to work different or
overlapping schedules in order to
accommodate all patients’ availability
by allowing the OTA/PTA to work
before or after the OTPP/PTPP normal
hours. The interested parties also stated
that the direct supervision requirement
can unfairly delay care for Medicare
patients when, for example, a PTPP or
OTPP is out sick, the practice does not
have alternative coverage, and
appointments for Medicare patients
must be canceled.
In light of this input, we believe that
the direct supervision requirement for
OTPPs and PTPPs of OTAs and PTAs,
respectively, may have had an
unintended consequence of limiting
access to needed therapy services. As
noted by interested parties, both the
OTPP/PTPP and their respective OTA/
PTA must be present in the office in
order to bill and receive Medicare
payment for therapy services furnished
by OTAs and PTAs. This means, for
example, that an OTPP/PTPP cannot bill
and receive payment for therapy
services furnished to a Medicare patient
in their home when furnished by an
OTA/PTA, without the presence of the
OTPP/PTPP. The direct supervision
requirement for OTAs and PTAs in the
private practice setting is more stringent
than the supervision requirements for
OTAs and PTAs in institutional settings.
For example, as we noted in the CY
2024 PFS proposed rule, 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 also cited Table 4 in our
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,’’ 142 in the CY 2024 PFS
default/files/resources/pdfs/Addressing-thehealthcare-staffing-shortage.pdf.
142 See Table 4 of the Report to Congress titled
Standards for Supervision of PTAs and the Effects
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proposed rule to demonstrate that the
minimum level of supervision by PTs
and OTs for services performed by PTAs
and OTAs working in institutional
settings is a general level of supervision,
in accordance with various regulations
(88 FR 52359). Therefore, we believe
that a change from direct to general
supervision would allow OTPPs and
PTPPs the flexibility to better
accommodate patients’ availability and
act to ensure access to necessary therapy
services. A change from direct to general
supervision would also allow OTPPs
and PTPPs to bill and receive Medicare
payment for therapy services furnished
by their OTAs and PTAs when they are
not in the office or patient’s home at the
same time.
We also believe that it is important to
better align our supervision policies for
OTPPs and PTPPs with the majority of
state-established supervision levels for
therapy assistants providing
occupational therapy and physical
therapy services. We note that the
majority of states allow OTs and PTs to
provide general supervision of their
respective OTAs and PTAs when
furnishing occupational therapy and
physical therapy services. We believe
that States are well aware of the health
and safety needs for their residents who
receive therapy services from OTs and
their supervised OTAs, and PTs and
their supervised PTAs. Given these
beliefs and the input from interested
parties, we are proposing to revise our
regulations at §§ 410.59(a)(3)(ii) and
(c)(2) and 410.60(a)(3)(ii) and (c)(2) to
allow for general supervision of OTAs
and PTAs by OTPPs and PTPPs, when
the OTAs and PTAs are furnishing
outpatient occupational and physical
therapy services, respectively. We
expect that this proposal would both
increase access to therapy services and
more closely align Medicare policy with
the majority of State practice acts for
occupational therapy and physical
therapy. This will parallel the 44 States
that allow general supervision of PTAs
and the 49 States that allow general
supervision of OTAs (most often
described as requiring the PT or OT to
be in touch via telecommunication). For
the States with more restrictive
supervision levels, such as direct
supervision, those therapy services are
always furnished to the extent that is
permitted under State law. We note that
while we are proposing to allow for
general supervision by OTPPs and
of Eliminating the Personal PTA Supervision
Requirement on the Financial Caps for Medicare
Therapy Services at https://www.cms.gov/Medicare/
Billing/TherapyServices/Downloads/
61004ptartc.pdf.
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PTPPs of their OTAs/PTAs, an OTPP or
PTPP would still be required to provide
direct supervision to unenrolled OTs
and PTs, respectively, in accordance
with §§ 410.59(c)(2) and 410.60(c)(2).
We are soliciting comment on our
proposals.
2. Certification of Therapy Plans of Care
With a Physician or NPP Order
Sections 1861(p), (g), and (ll)(2) of the
Act require that an individual
outpatient is under the care of a
physician and for whom a plan for the
physical therapy, occupational therapy,
or speech-language pathology services
that are to be furnished has been
established by a physician or by a
qualified PT, OT, or SLP and is
periodically reviewed by a physician.
Sections 1835(a)(2)(C) and 1835(a)(2)(D)
of the Act require that payment for
Medicare therapy services may be made
for outpatient physical therapy,
occupational therapy, and speechlanguage pathology services only if a
physician certifies (and recertifies,
where such services are furnished over
a period of time) that: (a) the services
are or were required because the patient
needs or needed therapy services; (b) a
plan for furnishing such services was
established by a physician or qualified
therapist providing such services, and is
periodically reviewed by the physician;
and (c) the services are or were
furnished while the individual was
under the care of a physician.
In accordance with the statute and
§ 424.24(b), Medicare Part B pays for
outpatient physical therapy and speechlanguage pathology services furnished
by providers only if a physician certifies
the content specified in § 424.24(c)(1) or
(4). We recognize that it may not be
clear that § 424.24(c) applies to the
occupational therapy services furnished
by providers, since occupational
therapy services are currently only
explicitly mentioned in the
recertification requirements at
§ 424.24(c)(4).
We note that there are multiple
references to § 424.24(c) in the Medicare
Benefit Policy Manual, Pub. 100–02,
chapter 15, sections 220.1—Conditions
of Coverage and Payment for Outpatient
Physical Therapy, Occupational
Therapy, or Speech-Language Pathology
Services, 220.1.2—Plans of Care for
Outpatient Physical Therapy,
Occupational Therapy, or SpeechLanguage Pathology Services, and
220.1.3—Certification and
Recertification of Need for Treatment
and Therapy Plans of Care, which
convey our current policy that all
outpatient physical therapy,
occupational therapy, and speech-
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language pathology services are subject
to requirements for certification and
recertification at § 424.24, whether
furnished by providers or by suppliers
such as therapists in private practice
(TPPs). We note that while section 1835
of the Act explicitly refers to services
furnished by providers of services,
which would include hospitals and
other institutional providers as defined
in section 1861(u) of the Act, and
clinics, rehabilitation agencies, or
public health agencies as further
described in section 1835(a) of the Act,
we have interpreted the requirements of
section 1835(a)(2)(C) and 1835(a)(2)(D)
as applying to therapy services
furnished by both providers and
suppliers. See Medicare Benefit Policy
Manual, Pub. 100–02, chapter 15,
sections 220.1, 220.1.2, and 220.1.3. We
believe that this interpretation is based
on the certification and recertification
requirements under section 1835(a) of
the Act as a way to effectuate the
requirement in sections 1861(p), (g), and
(ll)(2) of the Act that the patient is under
the care of a physician, and that the
plan of treatment/care for the physical
therapy, occupational therapy, or
speech-language pathology services has
been established by a physician or by a
qualified PT, OT, or SLP and is
periodically reviewed by a physician.
Additionally, we thought it was
important to establish conforming
policies for these therapy services in
both the outpatient provider and private
practice settings.
Due to the foregoing concerns, we are
proposing to revise the headings of
paragraphs (c) introductory text and
(c)(1)(i) to include the term
‘‘occupational therapy’’ after physical
therapy. We propose to replace the term
speech pathology with the accepted
term speech-language pathology in 42
CFR 424.24(c)(1)(i). We are also
proposing to add the term ‘‘occupational
therapist’’ to 42 CFR 424.24(c)(3)(ii)
between physical therapist and speechlanguage pathologist.
The regulations at 42 CFR 424.24(c)
require that a physician, nurse
practitioner (NP), physician assistant
(PA), or clinical nurse specialist (CNS)
who has knowledge of the case sign the
initial certification for the patient’s plan
of treatment. We remind readers that
plan of treatment is synonymous with
the ‘‘plan of care’’ mentioned above.
This terminology appears in several
sections of Pub. 100–02, chapter 15, and
both terms may be used
interchangeably. In accordance with
§ 424.24(c)(2), the initial certification
must be obtained as soon as possible
after the plan is established by a PT, OT,
or SLP. In Pub. 100–02, chapter 15,
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section 220.1.3 for Certification and
Recertification of Need for Treatment
and Therapy Plans of Care, we specify
that the physician or nonphysician
practitioner (NPP) must sign the initial
plan of care (POC) with a dated
signature or verbal order within 30 days
from the first day of treatment,
including evaluation (or 14 days if a
verbal order), in order for the PT, OT,
or SLP to be paid for the services. For
this reason, the manual also states that
the therapist should forward the
treatment plan to the physician/NPP as
soon as it is established rather than
waiting to do so. The manual allows for
a delayed certification when the
physician or NPP completes
certification and includes a reason for
the delay, and delayed certifications are
accepted without justification up to 30
days after the due date.
The regulations at § 424.24(c)(4)
require recertification at least every 90
days, and the plan or other
documentation in the patient’s medical
record must indicate the continuing
need for physical therapy, occupational
therapy, or speech-language pathology
services. The physician, nurse
practitioner, clinical nurse specialist, or
physician assistant who reviews the
plan must recertify the plan by signing
the medical record. Pub. 100–02,
chapter 15, section 220.1.4.C clarifies
that payment and coverage conditions
require that the plan of care be reviewed
as often as necessary but at least
whenever it is certified or recertified, in
order to meet the certification
requirements. We explained in the CY
2008 PFS final rule, when changing the
plan of care recertification interval from
30 to 90 days, this was done in order to
allow more flexibility to the physician/
NPP to order the appropriate amount of
therapy for each patient’s needs (72 FR
66333). Thus, a physician or nonphysician practitioner (NPP) may certify
or recertify a plan of care at an interval
the physician or NPP determines is
appropriate, as long as the amount of
time between each recertification does
not exceed 90 calendar days. As many
episodes of therapy treatment are
completed in less than 30 calendar days,
we expect that physicians and NPPs
will continue to certify plans of care
that appropriately estimate the duration
of needed therapy treatment for a
patient, even if the duration is less than
90 days.
Over the past two years,
representatives of several therapyrelated organizations have requested
that CMS reduce the administrative
burden involved with attempting to
obtain signed plans of treatment from
the physician/NPP. They expressed
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concern that therapists are held
accountable for the action or inaction of
physicians/NPPs who may be
overwhelmed with paperwork. These
interested parties report that therapists
make exhaustive efforts to obtain the
physician/NPP’s signature—some
reporting that they contact physician
offices (via phone, email, or fax, etc.)
more than 30 times. Without the
required signature, the therapist will not
meet the conditions to be paid for the
services they deliver. These interested
parties recommend that payment for
therapy services should be determined
by the medical necessity of the service
and whether the therapist has met their
statutory and regulatory requirements.
Some of these interested parties have
noted that Pub. 100–02, chapter 15,
section 220.1.1, states that the
physician/NPP order provides evidence
that the patient is under the care of a
physician and that the services are
medically necessary. Interested parties
told us that while CMS allows treatment
to begin before the physician’s/NPP’s
signature is obtained, PTs, OTs, and
SLPs in private practice do so at their
own risk, knowing that they might not
be paid for the services if the
physician’s office does not send back
the signed plan of treatment.
Accordingly, such interested parties
have said that care is delayed while
awaiting a physician’s signature, which
could place the beneficiary’s health at
risk due to the delay in obtaining
outpatient therapy services.
While we do not require an order or
referral for a Medicare patient to see a
PT, OT, or SLP, we have explained that
the presence of a signed order from the
treating physician satisfies statutory
requirements that therapy is/was
medically necessary and the patient is/
was under the care of a physician (Pub.
100–02, chapter 15, section 220.1.1).
However, with this order documented
in the medical record, after the therapist
evaluates the patient and establishes the
plan of treatment, based on the
evaluation’s findings, the therapist
forwards the patient’s plan of treatment
back to the referring physician/NPP to
obtain a dated signature for the same
patient with the same diagnosis to meet
coverage and payment conditions to
satisfy the initial certification
requirement—creating an administrative
burden for both the physician/NPP and
the therapist. Interested parties have
reported to us that most patients seeking
outpatient therapy services have written
orders from their physician, not to be
confused with a written plan of
treatment. These interested parties have
suggested that we amend the regulation
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at § 424.24(c) to permit the presumption
of a physician/NPP signature for
purposes of certification and
recertification in cases where a signed
written order or referral from the
patient’s physician/NPP is on file and
there is written documentation in the
patient’s medical record to substantiate
the method and date (such as a fax,
email, etc.) that the therapist forwarded
the plan of care to the physician/NPP.
Additionally, interested parties
representing all therapy disciplines
requested that CMS allot time for plan
of treatment changes. Interested parties
requested that when a physician/NPP
orders the therapy services, the
physician/NPP be allotted ten business
days to modify the plan of treatment by
contacting the therapist directly after
receiving it from the therapist. For
patients without a physician/NPP order,
interested parties requested that
physician/NPPs be given 30 days after
receipt of the plan of treatment to
modify the treatment plan.
After reviewing our current regulatory
requirements and considering the
suggestions of interested parties, we
believe it would be appropriate to
propose to amend the regulation at
§ 424.24(c) for those cases when a
patient has a signed and dated order/
referral from a physician/NPP for
outpatient therapy services. Since our
policy has been to accept the physician
or NPP’s signature on the plan of
treatment to be their certification of the
treatment plan’s conditions in the
content requirements of § 424.24(c)(1)—
that the patient needs or needed
physical therapy, occupational therapy
or speech-language pathology services,
the services were furnished while the
individual was under the care of a
physician, NP, PA, or CNS, and the
services were furnished under a plan of
treatment that meets the requirements of
§ 410.61—we propose that a signed and
dated order/referral from a physician/
NPP combined with documentation of
such order/referral in the patient’s
medical record along with further
evidence in the medical record that the
therapy plan of treatment was
transmitted/submitted to the ordering/
referring physician or NPP is sufficient
to demonstrate the physician or NPP’s
certification of these required
conditions. Rather than characterizing
this proposal as a ‘‘presumption,’’ we
are taking the view that when the
patient’s medical record includes a
signed and dated written order or
referral indicating the type of therapy
needed, CMS (and our contractors)
would treat the signature on the order
or referral as equivalent to a signature
on the plan of treatment. We believe our
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proposal would be reflective of the
intent of the ordering/referring
physician/NPP when that order/referral
is on file in the patient’s medical record.
We further believe that this would still
be consistent with the initial
certification required under section
1835(a) of the Act for providers of
therapy services and our current policy
for therapy in the private practice
setting. When the ordering/referring
physician writes the referral for the type
of therapy services they determine their
patient needs or needed, they also
review the treatment plan the therapist
established at the time it is forwarded to
them, and they verify that the services
are or were furnished while the patient
is or was under their care. As such, we
propose to carve out an exception to the
physician signature requirement at
§ 424.24(c) by adding a new paragraph
(c)(5). The proposed policy would be an
exception to the physician signature
requirement for purposes of an initial
certification in cases where a signed and
dated order/referral from a physician,
NP, PA, or CNS is on file and the
therapist has documented evidence that
the plan of treatment has been delivered
to the physician, NP, PA, or CNS within
30 days of completion of the initial
evaluation. However, at this time, we
are not proposing and do not intend to
establish an exception to the signature
requirement for purposes of
recertification of the therapy plan of
treatment. We believe that physicians
and NPPs should still be required to
sign a patient’s medical record to
recertify their therapy treatment plans,
in accordance with § 424.24(c)(4), to
ensure that a patient does not receive
unlimited therapy services without a
treatment plan signed and dated by the
patient’s physician/NPP.
Under our proposal, CMS or its
contractors would be able to treat the
physician/NPP signature on the order or
referral as equivalent to a signature on
the plan of treatment for purposes of the
initial certification if that physician/
NPP has not signed and returned the
patient’s plan of treatment to the
therapist within 30 days of the initial
evaluation, but only in cases where the
patient’s physician/NPP has signed and
dated the written order or referral and
indicated the type of therapy needed,
and that written order or referral is on
file in the medical record. This
proposed policy would not affect a
contractor’s ability or authority to
determine whether therapy services are
reasonable and necessary for a given
beneficiary. Lastly, because there is no
requirement for a physician/NPP order
or referral for patients to obtain
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61739
outpatient therapy services, we propose
to make clear in proposed § 424.24(c)(5)
that the references to an order or referral
in § 424.24(c)(5) shall not be construed
to require an order or referral for
outpatient physical therapy,
occupational therapy, or speechlanguage pathology services. We
welcome comments on this proposal.
In addition, we are soliciting
comments to gather more information
about the need for a regulation that
would address the amount of time for
changes to plans of treatment. Our
regulations at 42 CFR 410.61(d), which
are further clarified in our manual
provisions in Pub. 100–02, chapter 15,
section 220.1.2.C, currently allow for
changes to the treatment plan by the
physician/NPP without time
restrictions. Interested parties have
suggested that CMS allow physicians/
NPPs to have just ten business days
from the date of receipt of a plan of care
to modify that plan of care (in the case
of a patient with an order for the
therapy services). Additionally, we are
also soliciting comment as to whether
there should be a 90 calendar day time
limit on the order/referral for outpatient
therapy services in cases where the
order/referral is intended to be used in
relation to the proposed regulatory
amendment for the initial certification
of the treatment plan at § 424.24(c)(5)
discussed above—that 90-day limit
would span from the order/referral date
until the initial treatment of the patient,
including the evaluation furnished by
the PT, OT, or SLP. We also seek
feedback about whether this limit, or
one of a different duration, should be
incorporated into the regulatory
provision we proposed above for
§ 424.24(c)(5).
We want to clarify that we are not
proposing to amend § 424.27 for CORF
physical therapy, occupational therapy,
and speech-language pathology
treatment plans to align with our
proposed amendments at § 424.24
because section 1861(cc) of the Act and
regulation at 42 CFR 410.105(c) require
these treatment plans to be established
by a physician.
We are soliciting comments on these
proposals and comment solicitations.
3. KX Modifier Thresholds
The KX modifier thresholds were
established through section 50202 of the
Bipartisan Budget Act of 2018 (Pub. L.
115–123, February 9, 2018) (BBA) and
were formerly referred to as the therapy
cap amounts. 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
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each year based on the percentage
increase in the Medicare Economic
Index (MEI). 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 2025, we
propose to increase the CY 2024 KX
modifier threshold amount by the most
recent forecast of the 2017-based MEI.
For CY 2025, the proposed MEI increase
is estimated to be 3.6 percent and is
based on the expected historical
percentage increase of the 2017-based
MEI. Multiplying the CY 2024 KX
modifier threshold amount of $2,330 by
the proposed CY 2025 percentage
increase in the MEI of 3.6 percent
($2,330 × 1.036) and rounding to the
nearest $10.00 results in a proposed CY
2025 KX modifier threshold amount of
$2,410 for physical therapy and speechlanguage pathology services combined
and $2,410 for occupational therapy
services. We propose to update the MEI
increase for CY 2025 based on historical
data through the second quarter of 2024,
and we would use such data, if
appropriate, to determine the final MEI
percentage increase and the CY 2025 KX
modifier threshold amounts in the CY
2025 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
through CY 2027. Effective beginning
with CY 2028, the MR threshold levels
would be annually updated by the
percentage increase in the MEI, per
section 1833(g)(7)(B) of the Act.
Consequently, for CY 2025, 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 billing
pattern 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.
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(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 exceed one or both of
the KX modifier thresholds, therapy
suppliers and providers use the KX
modifier on claims for subsequent
medically necessary services. Using 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.
I. Advancing Access to Behavioral
Health Services
1. Safety Planning Interventions and
Post-Discharge Telephonic Follow-up
Contacts
a. Background
In the CY 2024 PFS proposed rule, we
sought comment on whether there is a
need for potential separate coding and
payment for interventions initiated or
furnished in the emergency department
(ED) or other crisis settings 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. Several
commenters encouraged CMS to enable
wider implementation under Medicare
of the Safety Planning Intervention (SPI)
and the Post-Discharge Telephonic
Follow-up Contacts Intervention (FCI)
and expressed that the current payment
mechanisms are not sufficient, noting
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that the lack of adequate payment
mechanisms and suitable billing codes
for these interventions are barriers that
are essential to address. The
commenters noted that EDs are not the
only care setting where there is need
and opportunity to enhance suicide
prevention, but that elevated suicide
risk is particularly prevalent among ED
patients. One commenter noted that a
designated code for SPI would make it
significantly easier to document that SPI
was furnished, including in quality
reporting and value-based payment
programs.
More than 49,000 people died by
suicide in 2022 and death by suicide is
growing significantly in older adults,
who comprise most of the Medicare
population. We recognize data showing
that suicide by intentional overdose is a
growing concern, particularly among
young people, older people, and Black
women, although researchers
acknowledge the complexities of
distinguishing intentional from
unintentional death.143
b. Safety Planning Interventions (SPI)
Safety planning interventions involve
a patient working with a clinician to
develop a personalized list of coping
strategies and sources of support that
the person can use in the event of
experiencing thoughts of harm to
themselves or others. This is not a
suicide risk assessment, but rather, an
intervention provided to people
determined to have elevated risk. Safety
planning interventions have also been
used to reduce the risk of overdose. The
basic components of a safety plan
include the following: (1) recognizing
warning signs of an impending suicidal
crisis or actions that increase the risk of
suicide; (2) employing internal coping
strategies; (3) utilizing social contacts
and social settings as a means of
distraction from suicidal thoughts and/
or taking steps to reduce the risk of
suicide; (4) utilizing family members,
significant others, caregivers, and/or
friends to help resolve the crisis; (5)
contacting mental health professionals,
crisis services, or agencies; and (6)
making the environment safe, including
restricting access to lethal means, as
applicable.144 One important aspect of
making an environment safe could be,
143 https://www.nih.gov/news-events/newsreleases/suicides-drug-overdose-increased-amongyoung-people-elderly-people-black-women-despiteoverall-downward-tren.
144 Barbara Stanley, Gregory K. Brown, Safety
Planning Intervention: A Brief Intervention to
Mitigate Suicide Risk, Cognitive and Behavioral
Practice, Volume 19, Issue 2, 2012, Pages 256–264,
ISSN 1077–7229, https://doi.org/10.1016/
j.cbpra.2011.01.001.
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for example, addressing a person’s
access to lethal means, such as firearms.
We understand that safety planning is
consistent with current practice
standards and that many hospitals and
clinicians in other settings are already
providing some or all of these services
to the people who need them, including
through the Department of Veterans
Affairs (VA).145 146 However, in one
survey of EDs, only 15.3 percent could
confirm routinely implementing safety
planning with all of the structured
elements mentioned above. Provision of
individual safety planning elements
ranged from 24.8 percent (n = 492) to
79.2 percent (n = 1710), with 2 of 6
elements being routinely provided more
than 50 percent of the time: lists of
professionals or agencies to contact in a
crisis (1710 [79.2 percent]) and helping
patients to recognize warning signs of
suicide (1075 [52.2 percent]).147 Suicide
risk among people with substance use
disorders who also are at high risk for
or may have experienced an intentional
overdose is not well recognized.148
Therefore, we are proposing to
establish separate coding and payment
under the PFS describing safety
planning interventions. Specifically, we
are proposing to create an add-on Gcode that would be billed along with an
E/M visit or psychotherapy when safety
planning interventions are personally
performed by the billing practitioner in
a variety of settings. We recognize that
training and expertise are needed to
perform these interventions safely and
appropriately and are seeking comment
regarding whether clinical staff who
meet the definition of auxiliary
personnel defined at 42 CFR
410.26(a)(1) or who are employed by a
hospital could participate in furnishing
this service under the supervision of the
billing practitioner in certain settings
with the relevant training needed to
perform the service as well as what sort
of training would be needed.
The proposed G-code is HCPCS code
GSPI1: Safety planning interventions,
including assisting the patient in the
identification of the following
145 https://www.mentalhealth.va.gov/docs/
vasafetyplancolor.pdf.
146 https://www.mirecc.va.gov/visn19/research/
our-research/implementation.asp.
147 Bridge JA, Olfson M, Caterino JM, Cullen SW,
Diana A, Frankel M, Marcus SC. Emergency
Department Management of Deliberate Self-harm: A
National Survey. JAMA Psychiatry. 2019 Jun
1;76(6):652–654. doi: 10.1001/
jamapsychiatry.2019.0063. PMID: 30865243;
PMCID: PMC6552299.
148 Ries RK, Livengood AL, Huh D, et al.
Effectiveness of a Suicide Prevention Module for
Adults in Substance Use Disorder Treatment: A
Stepped-Wedge Cluster-Randomized Clinical Trial.
JAMA Netw Open. 2022;5(4):e222945. doi:10.1001/
jamanetworkopen.2022.2945.
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personalized elements of a safety plan:
recognizing warning signs of an
impending suicidal crisis; employing
internal coping strategies; utilizing
social contacts and social settings as a
means of distraction from suicidal
thoughts; utilizing family members,
significant others, caregivers, and/or
friends to help resolve the crisis;
contacting mental health professionals
or agencies; and making the
environment safe; (List separately in
addition to an E/M visit or
psychotherapy). We welcome comments
on the proposed elements of the safety
planning code.
We are proposing to value HCPCS
code GSPI1 based on the valuation for
CPT code 90839 (Psychotherapy for
crisis), which describes 60 minutes, and
which we believe describes a similar
level of intensity as HCPCS code GSPI1.
For HCPCS code GSPI1, we are
assuming a typical time of 20 minutes,
resulting in a proposed work RVU of
1.09 (based on one third of the work
value currently assigned to CPT code
90839, which is 3.28). We welcome
comments on whether 20 minutes
accurately captures the typical amount
of time spent with a patient on safety
planning interventions, including all six
elements enumerated in this section.
Additionally, we welcome comments on
whether these interventions typically
occur in the context of an encounter,
such as an E/M visit or psychotherapy,
or whether there may be times when
they may be furnished as a standalone
service and whether we should consider
allowing this code to be billed on its
own. We also welcome comments
regarding which clinician types might
be most likely to bill such a code on its
own.
c. Post-Discharge Telephonic Follow-Up
Contacts Intervention (FCI)
Some research suggests that patients
seen in the ED with deliberate selfharm, intentional overdose, and/or
suicidal ideation have been associated
with substantially increased risk of
suicide and other mortality during the
year following their visit to the ED.149
FCI is a specific protocol of services for
individuals with suicide risk involving
a series of telephone contacts between a
provider and patient in the weeks and
sometimes months following discharge
from the emergency department and
other relevant care settings, that occurs
149 Goldman-Mellor S, Olfson M, Lidon-Moyano
C, Schoenbaum M. Association of Suicide and
Other Mortality With Emergency Department
Presentation. JAMA Netw Open. 2019 Dec
2;2(12):e1917571. doi: 10.1001/
jamanetworkopen.2019.17571. PMID: 31834399;
PMCID: PMC6991205.
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when the person is in the community
and is designed to reduce the risk for
subsequent adverse outcomes. FCI calls
are typically 10–20 minutes in duration
and aim to encourage use of the Safety
Plan (as needed in a crisis) and updating
it to optimize effectiveness, expressing
psychosocial support, and helping to
facilitate engagement in any indicated
follow-up care and services. We note
that this service would not be within the
scope of Medicare telehealth services
and not subject to the restrictions
described in Section 1834(m) because
these services are specifically structured
to be delivered via audio-only phone
calls and are not a substitute for an inperson service.
In a recent study led by the Joint
Commission, which surveyed a national
sample of hospitals to assess the
prevalence of SPI and several other
recommended suicide prevention
services, fewer than half of responding
hospitals reported furnishing any postdischarge follow-up contacts. Of these,
only 33 percent (16 percent of
responding hospitals overall) reported
reaching discharged patients ‘‘most of
the time.’’ Further, among hospitals that
furnish follow-up contacts, fewer than
half reported covering any of the main
aims of FCI, for example, 41 percent
review the Safety Plan, 49 percent
provide psychosocial support, and 38
percent facilitate outpatient care.150
However, some studies have
demonstrated that SPI and other
services may be able to reduce suicidal
behaviors. For example, in the ED–
SAFE trial for emergency department
(ED) patients identified with elevated
suicide risk, the intervention included
SPI and up to seven post-discharge
follow-up calls with the patient
‘‘focused on identifying suicide risk
factors, clarifying values and goals,
safety and future planning, facilitating
treatment engagement/adherence, and
facilitating patient-significant other
problem-solving.’’ 151 In the SAFE VET
study 152 of ED patients identified with
elevated suicide risk, the intervention
included SPI and at least two follow-up
calls with patients ‘‘to monitor suicide
risk, review and revise the SPI, and
150 https://www.sciencedirect.com/science/
article/pii/S1553725024000679?via%3Dihub.
151 Miller IW, Camargo CA Jr, Arias SA, Sullivan
AF, Allen MH, Goldstein AB, Manton AP, Espinola
JA, Jones R, Hasegawa K, Boudreaux ED; ED–SAFE
Investigators. Suicide Prevention in an Emergency
Department Population: The ED–SAFE Study.
JAMA Psychiatry. 2017 Jun 1;74(6):563–570. doi:
10.1001/jamapsychiatry.2017.0678. PMID:
28456130; PMCID: PMC5539839.
152 https://pubmed.ncbi.nlm.nih.gov/29998307/.
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support treatment engagement.’’ 153
Each of these studies reported
significantly lower suicide behaviors—
attempts and/or deaths—among
intervention patients compared to the
respective control conditions.
In light of this, we are proposing to
create a monthly billing code to describe
the specific protocols involved in
furnishing post-discharge follow-up
contacts that are performed in
conjunction with a discharge from the
emergency department for a crisis
encounter, as a bundled service
describing four calls in a month, each
lasting between 10–20 minutes. The
proposed G-code is HCPCS code GFCI1:
Post discharge telephonic follow-up
contacts performed in conjunction with
a discharge from the emergency
department for behavioral health or
other crisis encounter, per calendar
month. We seek comment on whether
we should consider finalizing a
specified duration that HCPCS code
GFCI1 could be billed) following
discharge, for example, allowing this
code to be billed for up to two months
following discharge or whether a longer
duration would be appropriate, the
number of calls per month, the billing
structure (for example, four calls for
each discharged patient), and any other
relevant feedback.
We are proposing to price this service
based on a direct crosswalk to CPT code
99426 (Principal care management; first
30 minutes of clinical staff time directed
by a physician or other qualified
healthcare professional), which is
assigned a work value of 1.00 work
RVUs. Since CPT code 99426 describes
care management for a single condition,
we believe the work would be similar in
nature and intensity. We note that under
this proposal, proposed HCPCS code
GFCI1 could be billed regardless of
whether proposed HCPCS code GSPI1
was also furnished and billed for the
same patient. We propose that the
billing practitioner would need to meet
a threshold of at least one real-time
telephone interaction with the patient in
order to bill HCPCS code GFCI1, and
that unsuccessful attempts to reach the
patient would not qualify as a real-time
telephone interaction. We welcome
comments on this proposed threshold to
bill HCPCS code GFCI1, recognizing
that while practitioners may attempt to
153 Stanley B, Brown GK, Brenner LA, Galfalvy
HC, Currier GW, Knox KL, Chaudhury SR, Bush AL,
Green KL. Comparison of the Safety Planning
Intervention With Follow-up vs Usual Care of
Suicidal Patients Treated in the Emergency
Department. JAMA Psychiatry. 2018 Sep
1;75(9):894–900. doi: 10.1001/
jamapsychiatry.2018.1776. PMID: 29998307;
PMCID: PMC6142908.
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reach the patient, there may be times
when the patient cannot be reached. We
are also proposing that the billing
practitioner could not count time or
effort more than once for the purposes
of billing this code and another service.
Additionally, as we recognize that
behavioral health practitioners, training
programs, and institutions have worked
conscientiously to have risk assessment
and safety planning for high-risk
patients integrated into their workflows
for many years and that discharge
instructions and after visit planning
may represent one of many final
products from the synthesis of all the
steps involved in these encounters, we
note that we do not intend to
unnecessarily disaggregate aspects of
streamlined clinical workflows that
providers are successfully using to treat
high risk patients. Moreover, we also
recognize that practitioners may
currently be billing for safety planning
activities using existing coding, such as
E/M visits, psychotherapy, and crisis
management codes or potentially for
follow-up calls using existing care
management services. However, to the
extent that this intervention is part of
the standard of care, we believe that
Medicare payment should accurately
reflect the additional resource costs
involved in furnishing this service.
Lastly, as applicable Part B cost
sharing would apply for HCPCS code
GFCI1, we are proposing to require the
treating practitioner to obtain verbal (or
written) beneficiary consent in advance
of furnishing the services described by
GFCI1, which would be documented by
the treating practitioner in the medical
record, similar to the conditions of
payment associated with care
management and other non-face-to-face
services paid under the PFS. We note
that under this proposal, obtaining
advance consent would include: (1)
ensuring that the patient is aware that
Medicare cost sharing applies to these
services; (2) furnishing and receiving
the necessary information to enable the
patient to receive these services (for
example, obtaining the patient’s
telephone number(s)); and (3)
confirming that the patient consents to
the contacts.
2. Digital Mental Health Treatment
(DMHT)
We are proposing Medicare payment
to billing practitioners for digital mental
health treatment (DMHT) devices
furnished incident to or integral to
professional behavioral health services
used in conjunction with ongoing
behavioral health care treatment under
a behavioral health treatment plan of
care. We are refining the digital
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cognitive behavioral therapy ‘‘digital
CBT’’ terminology that we have used
previously (88 FR 52262, 52370 through
52371, 88 FR 78818, 79012 and 79013).
We are proposing Medicare payment to
billing practitioners for digital mental
health treatment (DMHT) devices
furnished incident to or integral to
professional behavioral health services
used in conjunction with ongoing. In
this proposed rule we use the term
‘‘digital mental health treatment
(DMHT) device’’ to include the term
‘‘digital CBT’’ we used in prior
rulemaking and in general to refer to
software devices cleared by the Food
and Drug Administration (FDA) that are
intended to treat or alleviate a mental
health condition, in conjunction with
ongoing behavioral health care
treatment under a behavioral health
treatment plan of care, by generating
and delivering a mental health
treatment intervention that has a
demonstrable positive therapeutic
impact on a patient’s health. We note
first that the Diagnostic and Statistical
Manual of Mental Disorders-5 (DSM)
does not refer to psychiatric disorders
but to mental disorders. In this section,
following the DSM, we use the term
behavioral health conditions and mental
disorders interchangeably and to mean
psychiatric disorders as referenced in
FDA regulation, 21 CFR 882.5801.
Second, we note that FDA guidance
refers to computerized behavioral
therapy by the acronym CBT. We aim to
both provide access to vital behavioral
health services and gather further
information about the delivery of digital
behavioral health therapies, their
effectiveness, their adoption by
practitioners as complements in the care
they furnish, and their use by patients
for the treatment of behavioral health
conditions. We also recognize that there
are certain statutory limitations on
payment for products under the broader
category of ‘‘digital health
interventions.’’ We acknowledge that
the field of digital therapeutics is
evolving and are open to feedback from
the public on this topic, including the
CPT Editorial Panel. Additionally, we
recognize that historically, the CPT
Editorial Panel has frequently created
CPT codes describing services that we
originally established using G codes and
adopted them through the CPT Editorial
Panel process. We note that we would
consider using any newly available CPT
coding to describe services similar to
those described here in future
rulemaking.
a. Background
Over the last 5 years the AMA CPT
Editorial Panel and CMS have
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developed coding and separate payment
for monitoring physiologic status using
software enabled devices that capture
and record or transmit data that may be
reported to and interpreted by
practitioners to manage a patient under
a specific treatment plan. (83 FR 59452,
59574) Medicare payment has long been
available for practitioner provision of
monitoring equipment and other kinds
of devices provided incident to or
integral to the practitioner’s professional
services. Most recently we have
finalized payment for devices which
record data related to signs, symptoms,
and functions of a therapeutic response
(typically for use in association with
physical or occupational therapy care)
(86 FR 64996, 65114–65116).
However, technologies that rely
primarily on software, licensing, and
analysis fees, with minimal costs in
equipment and hardware may not have
been typical and are not well accounted
for in our practice expense (PE)
methodology. PE resources involved in
furnishing services are characterized as
either direct or indirect costs. Direct
costs of the PE resources involved in
furnishing a service are estimated for
each HCPCS code and include clinical
labor, medical supplies, and medical
equipment. Indirect costs include
administrative labor, office expenses,
and all other expenses. Indirect PE is
allocated to each service based on
physician work, direct costs, and a
specialty-specific indirect percentage.
The source of the specialty specific
indirect percentage is the Physician
Practice Information Survey (PPIS), last
administered in 2007 and 2008, prior to
the adoption of digital therapy
technologies (86 FR 65037).
Nevertheless, in past rulemaking, we
have recognized that in some cases
practitioners do incur resource costs for
the purchase and ongoing use of
software (86 FR 65038).
In the CY 2023 PFS final rule, we
finalized our proposal to accept the RUC
recommendation to contractor price
CPT code 98978 (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), a PE-only device code (86
FR 69523, 69646). At the time, specialty
societies indicated that the technologies
for this service are still evolving, and
that 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. There was no professional work
associated with the code.
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In the CY 2024 PFS proposed rule, we
requested information on digital
therapeutics for behavioral health.
Among many questions, we asked how
practitioners determine which patients
might be best served by digital
therapeutics and how practitioners
monitor the effectiveness of prescribed
interventions on an ongoing basis once
the intervention has begun. We also
asked how the treating clinician was
involved in the services received. We
asked what scientific and clinical
evidence of effectiveness CMS should
consider when determining whether
digital therapeutics for behavioral
health, including care for substance use
disorders, depression, sleep disorders
and other conditions are reasonable and
necessary. We asked whether DMHT
devices were used as incident to
supplies or independent of a patient
visit with a practitioner and if
practitioners in such cases issued an
order for such devices (88 FR 52262,
52370 through 52371). These factors
related to the nature of this treatment
compared to other PFS services pose
challenges for fitting DMHT services
into the existing benefit structure under
the PFS.
Setting appropriate pricing under the
PFS has also presented challenges. As
noted previously, technologies that rely
primarily on software, licensing, and
analysis fees, with minimal costs in
equipment and hardware are not well
accounted for in our practice expense
(PE) methodology, even though these
items may be appropriately considered
practice expenses. Consequently, over
the past several years, we have relied on
a crosswalk methodology to
approximate relative resource costs for
these kinds of services relative to other
PFS services, or contractor pricing.
Interested parties requested that we
adopt coding specifically for DMHT
devices, where the digital software
device is the actual therapy/intervention
(the algorithm software is the DMHT) as
opposed to a therapeutic monitoring
device that transmits patient data as
described by CPT code 98978 for which
we finalized contractor pricing in CY
2023. Interested parties have also asked
us to set national pricing for the service
to supply the DMHT device and
education/onboarding that reflects the
direct practice expense incurred by
practitioners when furnishing DMHT.
One of the interested parties submitted
invoices to provide data we could use
as the basis to set payments for DMHT
coding. The interested party submitted
four invoices reflecting considerable
variation in the cost of the DMHT
treatment over 30-day and 90-day
periods. There is still more variation in
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pricing for comparable products that are
available for considerably lower prices
in various markets, with prices ranging
from free to $140 per year, based on an
online search (https://
www.carepatron.com/app/cbt-therapyapps, accessed March 20, 2024).
As the field of innovative products
including digital therapeutics and
computerized behavioral therapy
devices for psychiatric or mental
disorders develops and expands, the
FDA and Substance Abuse and Mental
Health Services Administration
(SAMHSA) among other agencies such
as the Veterans Health Administration
(VHA) are also monitoring the
development of the field of digital
therapeutic devices, including for
behavioral health purposes. For
example, VHA is providing digital
behavioral health applications as selfhelp tools, not independent treatment
interventions. The FDA has a regulatory
framework, discussed below in this
section, to classify devices and review
computerized behavioral therapy
devices for psychiatric disorders.
b. Payment for Digital Mental Health
Treatment (DMHT) Devices
We recognize that digital therapeutics
may offer innovative means to access
certain behavioral health care services.
The FDA definition of devices
encompasses software intended by the
manufacturer to be used, alone or in
combination for the specific medical
purpose of diagnosis, prevention
monitoring treatment or alleviation of
disease and does not achieve its primary
intended action by pharmacological,
immunological or metabolic means.154
SAMHSA has defined digital
therapeutics (DTx) in the behavioral
health context as ‘‘health software
intended to treat or alleviate a disease,
disorder, condition, or injury by
generating and delivering a medical
intervention that has a demonstrable
positive therapeutic impact on a
patient’s health.’’ 155 SAMHSA also
notes that ‘‘DTx may be used
independently or in concert with
medications, devices, or other therapies
to optimize patient care and health
outcomes.’’ Given nationwide
behavioral health workforce shortages
combined with increasing demand for
behavioral health care services, some
Medicare beneficiaries may have limited
154 https://www.imdrf.org/sites/default/files/docs/
imdrf/final/technical/imdrf-tech-131209-samd-keydefinitions-140901.pdf.
155 https://store.samhsa.gov/product/advisorydigital-therapeutics-management-and-treatmentbehavioral-health/pep23-06-00-001.
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access to these services.156 This
proposal encompasses only part of what
may be a spectrum of broadly similar
products, most of which might require
a new statutory Medicare benefit
category. Our proposed coding and
payment policy only applies to DMHT
devices that have been cleared by the
FDA. Many digital platforms and
applications are marketed as behavioral
health and wellness interventions; this
proposal does not extend to such
platforms and applications in part
because other than some DTx, few have
evidence demonstrating improved
behavioral health outcomes.157
We propose to create three new
HCPCS codes for DMHT devices
modeled on coding for RTM services.
Effective beginning in CY 2025, we
propose that physicians and
practitioners who are authorized to
furnish services for the diagnosis and
treatment of mental illness would be
able to bill a new HCPCS code: GMBT1
(Supply of digital mental health
treatment device and initial education
and onboarding, per course of treatment
that augments a behavioral therapy
plan) for furnishing a DMHT device.
GMBT1 would be payable only if the
DMHT device has been FDA cleared and
the billing practitioner is incurring the
cost of furnishing the DMHT device to
the beneficiary. Furnishing of the
DMHT device must be incident to the
billing practitioner’s professional
services in association with ongoing
treatment under a plan of care by the
billing practitioner. The billing
practitioner must diagnose the patient
and prescribe or order the DMHT
device. The patient could then use the
DMHT device at home or perhaps in an
office or other outpatient setting, if that
is how the device has been cleared by
FDA for use under 21 CFR 882.5801.
The DMHT device furnished must have
demonstrated a reasonable assurance of
safety and effectiveness. The FDA
makes a determination of safety and
effectiveness under 21 CFR 860.7. When
making this determination, the FDA will
consider a variety of factors including
users, conditions of use, probable
benefit to health weighed against
probable injury, and reliability. The
regulation at 21 CFR 860.7, states that
‘‘[t]here is reasonable assurance that a
device is safe when it can be
determined, based upon valid scientific
evidence, that the probable benefits to
health from use of the device for its
156 https://bhw.hrsa.gov/sites/default/files/
bureau-health-workforce/data-research/behavioralhealth-2013-2025.pdf.
157 https://store.samhsa.gov/product/advisorydigital-therapeutics-management-and-treatmentbehavioral-health/pep23-06-00-001.
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intended uses and conditions of use,
when accompanied by adequate
directions and warnings against unsafe
use, outweigh any probable risks.’’
GMBT1 would not be payable in cases
where the billing practitioner incurs no
cost in acquiring and furnishing the
DMHT device, or a patient procures the
DMHT device independent of the
practitioner. We will continue to
monitor how DMHT devices are used as
part of overall care.
We seek comment about other
parameters that we should consider
regarding the services described by
GMBT1:
• Whether payment should be made
if the practitioner furnishes a digital
device that has not been cleared by FDA
for mental health treatment for a
specific use, even if the digital device
has been cleared by the FDA for another
specific use;
• Whether payment should be made
for DMHT devices cleared by the FDA
not only under 21 CFR 882.5801 but
also under other regulations;
• Whether and how payment might
be limited if a patient discontinues use
of the DMHT device before completing
a course of treatment; and
• Whether and how payment might
be limited to a set number of DMHT
devices per calendar month per patient.
In light of the pricing variability, as
discussed above, we are proposing
contractor pricing for code GMBT1. We
seek comment regarding what national
pricing methodology we might consider,
including what potential crosswalks
would be appropriate.
We are also proposing to establish
payment for two additional new codes.
These proposed codes are GMBT2 (First
20 minutes of monthly treatment
management services directly related to
the patient’s therapeutic use of the
digital mental health treatment (DMHT)
device that augments a behavioral
therapy plan, physician/other qualified
health care professional time reviewing
data generated from the DMHT device
from patient observations and patient
specific inputs in a calendar month and
requiring at least one interactive
communication with the patient/
caregiver during the calendar month)
and GMBT3 (Each additional 20
minutes of monthly treatment
management services directly related to
the patient’s therapeutic use of the
digital mental health treatment (DMHT)
device that augments a behavioral
therapy plan, physician/other qualified
health care professional time reviewing
data generated from the DMHT device
from patient observations and patient
specific inputs in a calendar month and
requiring at least one interactive
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communication with the patient/
caregiver during the calendar month).
Under this proposal, GMBT1 requires
that the billing practitioner who
diagnosed the patient and prescribed or
ordered the DMHT device or that billing
practitioner’s clinical staff must monitor
the patient’s therapeutic response to the
DMHT device and adjust the behavioral
health therapy plan as needed. GMBT2
and GMBT3 should only be billed when
there is ongoing use of the DMHT
device and should not be billed in cases
where the patient discontinues use of
the DMHT device.
For GMBT2 (first 20 minutes of
monthly treatment management services
directly related to use of the DMHT
device), we propose valuing the first 20
minutes of treatment management
services based on a direct crosswalk to
CPT code 98980 (remote therapeutic
monitoring first 20 minutes), which is
assigned a work RVU of .62. For GMBT3
(each additional 20 minutes of monthly
treatment management services directly
related to DMHT device), we propose to
value this code based on a crosswalk to
CPT code 98981 (remote therapeutic
monitoring each additional 20 minutes),
which is assigned a work RVU of .61.
We believe that the work and PE
described by these crosswalk codes are
analogous to the services described in
GMBT2 and GMBT3, respectively,
because they include similar physician/
other qualified health care professional
time in a calendar month requiring at
least one interactive communication
with the patient/caregiver during the
calendar month. We welcome comments
on the proposed RVUs.
3. Interprofessional Consultation Billed
by Practitioners Authorized by Statute
To Treat Behavioral Health Conditions
a. Background
In the CY 2019 PFS final rule (83 FR
59489), we finalized payment for six
CPT codes regarding interprofessional
consultations (99451, 99452, 99446,
99447, 99448, 99449). The six codes
describe assessment and management
services conducted through telephone,
internet, or electronic health record
consultations furnished when a
patient’s treating physician or other
qualified healthcare professional
requests the opinion and/or treatment
advice of a consulting physician or
qualified healthcare professional with
specific specialty expertise to assist
with the diagnosis and/or management
of the patient’s condition without the
need for the patient’s face-to-face
contact with the consulting physician or
qualified healthcare professional. We
established coding and payment for
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these services to reflect changing
healthcare practices, technology, and
the shift to treatment of chronic
conditions in the Medicare population.
In the CY 2019 PFS final rule (83 FR
59491), we established a policy to limit
billing of these codes to the types of
practitioners who can independently
bill Medicare for E/M visits. We did not
finalize the expansion of practitioners
beyond those who can furnish E/M
visits in the CY 2019 PFS final rule due
to our belief that interprofessional
consultations are primarily for the
ongoing evaluation and management of
the patient, including collaborative
medical decision making among
practitioners (83 FR 59491).
In the CY 2024 PFS proposed rule (88
FR 52369), we sought comment on
expanding access to behavioral health
services, including whether we should
consider new coding to allow
interprofessional consultation to be
billed by practitioners in specialties
whose covered services are limited by
statute (Clinical psychologists at section
1861(ii) of the Act, Clinical social
workers at section1861(hh) of the Act,
Marriage and Family Therapists and
Mental Health Counselors at sections
1861(lll)(1) and 1861(lll)(3) of the Act,
respectively) to services for the
diagnosis and treatment of mental
illness (which includes substance use
disorders). The CPT codes describing
interprofessional consultation (CPT
codes 99451, 99452, 99446, 99447,
99448, 99449) are currently limited to
being billed by practitioners who can
independently bill Medicare for E/M
visits. As such, they cannot be billed by
clinical psychologists, clinical social
workers, marriage and family therapists,
or mental health counselors because
these practitioners cannot
independently bill Medicare for E/M
visits. We are proposing new codes that
would allow clinical psychologists,
clinical social workers, marriage and
family therapists, and mental health
counselors to bill for interprofessional
consultations with other practitioners
whose practice is similarly limited, as
well as with physicians and
practitioners who can bill Medicare for
E/M services and would use the current
CPT codes to bill for interpersonal
consultations. These new codes would
facilitate interprofessional consultations
between treating/requesting
practitioners and consultant
practitioners, whether one or both of the
practitioners is in a specialty whose
practice is limited to the diagnosis and
treatment of mental illness. When the
treating/requesting practitioner or
consultant practitioner is a physician or
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practitioner authorized to bill Medicare
for E/M services, the practitioner would
continue to bill using the current CPT
codes that describe interprofessional
consultation, listed previously in this
section. Depending on which
practitioner type is billing, and
assuming all service requirements of the
code descriptors are met, the consulting
practitioner could bill the applicable
codes, either HCPCS code (GIPC1–5) or
CPT code (99451, 99452, 99446, 99447),
determined by the amount of time spent
on the consultation and whether a
written and verbal consultation is
provided or only a written consultation
is provided. Similarly, depending on
which practitioner type is billing, and
assuming all service requirements of the
code descriptors are met, the treating/
requesting practitioner could bill either
HCPCS code GIPC6 or CPT code 99449
for the time spent on their referral
service.
We believe that proposing payment
for these interprofessional consultations
performed via communications
technology such as telephone or internet
(including videoconference) is
consistent with our ongoing efforts to
appropriately recognize and reflect
behavioral health care within the PFS.
Currently, there is no payment
mechanism to recognize the time and
effort of performing these services by
clinical psychologists, clinical social
workers, marriage and family therapists,
or mental health counselors. We have
also previously received comments from
interested parties that by not making
separate payment for these services,
CMS would not be accurately paying for
the work of both the treating and
consulting practitioner in a consultative
scenario. With the proliferation of teambased approaches to care that are often
facilitated by electronic medical record
technology, we believe that making
separate payment for interprofessional
consultations undertaken for the benefit
of treating a patient will contribute to
payment accuracy under the PFS for
behavioral health services.
b. Coding
To further expand access to
behavioral health services, we are
proposing payment for six new G codes:
GIPC1 (Interprofessional telephone/
internet/electronic health record
assessment and management service
provided by a practitioner in a specialty
whose covered services are limited by
statute to services for the diagnosis and
treatment of mental illness, including a
verbal and written report to the patient’s
treating/requesting practitioner; 5–10
minutes of medical consultative
discussion and review), GIPC2
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(Interprofessional telephone/internet/
electronic health record assessment and
management service provided by a
practitioner in a specialty whose
covered services are limited by statute to
services for the diagnosis and treatment
of mental illness, including a verbal and
written report to the patient’s treating/
requesting practitioner; 11–20 minutes
of medical consultative discussion and
review), GIPC3 (Interprofessional
telephone/internet/electronic health
record assessment and management
service provided by a practitioner in a
specialty whose covered services are
limited by statute to services for the
diagnosis and treatment of mental
illness, including a verbal and written
report to the patient’s treating/
requesting practitioner; 21–30 minutes
of medical consultative discussion and
review), GIPC4 (Interprofessional
telephone/internet/electronic health
record assessment and management
service provided by a practitioner in a
specialty whose covered services are
limited by statute to services for the
diagnosis and treatment of mental
illness, including a verbal and written
report to the patient’s treating/
requesting practitioner; 31 or more
minutes of medical consultative
discussion and review), GIPC5
(Interprofessional telephone/internet/
electronic health record assessment and
management service provided by a
practitioner in a specialty whose
covered services are limited by statute to
services for the diagnosis and treatment
of mental illness, including a written
report to the patient’s treating/
requesting practitioner, 5 minutes or
more of medical consultative time), and
GIPC6 (Interprofessional telephone/
internet/electronic health record referral
service(s) provided by a treating/
requesting practitioner in a specialty
whose covered services are limited by
statute to services for the diagnosis and
treatment of mental illness, 30 minutes).
We welcome comments on this
proposal.
Additionally, since these codes
describe services that are furnished by
the treating/requesting practitioner and
the consultant practitioner without the
involvement of the patient, we are
proposing to require the treating
practitioner to obtain the patient’s
consent in advance of these services,
which would be documented by the
treating practitioner in the medical
record, similar to the conditions of
payment associated with the CPT
interprofessional consultation codes and
certain other non-face-to-face services
paid under the PFS. Obtaining advance
patient consent includes ensuring that
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the patient is aware that Medicare cost
sharing applies to these services,
including informing the patient that
there may be cost sharing for two
services (one for the treating/requesting
practitioner’s service and another for the
consultant practitioner’s service). We
welcome comments on this proposal.
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c. Valuation
We are proposing to value the six
proposed new G codes based on
crosswalks to the six CPT codes for
interprofessional consultations for
practitioners who can independently
bill Medicare for E/M visits (CPT codes
99451, 99452, 99446, 99447, 99448,
99449). We are proposing a work RVU
of 0.35 for GIPC1 based on a crosswalk
to CPT code 99446, a work RVU of 0.70
for GIPC2 based on a crosswalk to CPT
code 99447, a work RVU of 1.05 for
GIPC3 based on a crosswalk to CPT code
99448), a work RVU of 1.40 for GIPC4
based on a crosswalk to CPT code
99449, a work RVU of 0.70 for GIPC5
based on a crosswalk to CPT code
99451, and a work RVU of 0.70 for
GIPC6 based on a crosswalk to 99452.
Since there are no direct PE inputs
assigned to the six CPT codes describing
interprofessional consultation services
on which we are basing the proposed
valuation for the new HCPCS codes
GIPC1 through GIPC6, we are not
proposing any direct PE inputs for these
codes. We welcome comments on this
proposal.
4. Comment Solicitation on Payment for
Services Furnished in Additional
Settings, Including Freestanding SUD
Treatment Facilities, Crisis Stabilization
Units, Urgent Care Centers, and
Certified Community Behavioral Health
Clinics (CCBHCs)
In the CY 2024 OPPS final rule (88 FR
81809 through 81858), we finalized
payment for IOP services furnished in
hospital outpatient departments
(HOPDs), Community Mental Health
Centers (CMHCs), Federally Qualified
Health Centers (FQHCs), and Rural
Health Clinics (RHCs), and Opioid
Treatment Programs (OTPs). We note
that Section 4124 of the Consolidated
Appropriations Act (CAA), 2023,
authorized payment for IOP services in
HOPDs, CMHCs, FQHCs, RHCs, and that
we additionally used existing statutory
authority to propose and finalize
payment for IOP services furnished in
OTPs. CMS is monitoring utilization
and uptake of IOP services in these
settings. We have heard from other
treatment settings that furnish IOP
services that do not fall into the
categories of HOPDs, CMHCs, FQHCs,
RHCs, or OTPs, such as freestanding
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SUD facilities, that have an interest in
billing Medicare for these services. In
light of this, we are seeking comment on
whether IOP services are furnished in
other settings in order to determine
whether potential coding and payment
for IOP services under the PFS would
facilitate these services being billed in
additional settings.
In particular, we are interested in
feedback on the following questions, as
well as any other relevant feedback:
• To what extent do freestanding SUD
facilities or other entities that furnish
IOP services employ practitioner types
who can supervise auxiliary personnel
and bill Medicare for their services? For
example, do they typically employ
physicians, clinical psychologists, nurse
practitioners, clinical nurse specialists,
certified nurse midwives and physician
assistants who are eligible to provide
general supervision to auxiliary
personnel who furnish behavioral
health services?
• Would bundled payments under the
PFS similar to those finalized in the CY
2024 OPPS final rule (88 FR 81809–
81858) better facilitate billing for IOP
services in a broader range of settings?
• If CMS outlined how freestanding
SUD facilities could bill Medicare under
the PFS, would there be an impact in
underserved areas?
• To what extent do freestanding SUD
facilities see patients with Medicare or
who are dually eligible for Medicare and
Medicaid?
Additionally, we are seeking
comment on entities that offer
community-based crisis stabilization,
including 24/7 receiving and short-term
stabilization centers, that provide
immediate access to voluntary and/or
involuntary care, without the need for a
referral. Regarding such crisis
stabilization units, we are interested in
feedback on the following questions, as
well as any other relevant feedback:
++ What kind of services do crisis
stabilization units provide? Do crisis
stabilization units provide services
similar to those described by the
psychotherapy for crisis codes (CPT
codes 90839 and 90840)?
++ Does the definition of crisis
stabilization unit vary by State? If so,
what are the variations and similarities
across States?
++ If CMS outlined how crisis
stabilization units could bill Medicare
under the PFS, would there be an
impact in underserved areas?
++ To what extent do crisis
stabilization units see patients with
Medicare or who are dually eligible for
Medicare and Medicaid?
++ To what extent do crisis
stabilization units employ practitioner
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types who can supervise auxiliary
personnel and bill Medicare for their
services. For example, do crisis
stabilization units typically employ
physicians, clinical psychologists, nurse
practitioners, clinical nurse specialists,
certified nurse midwives and physician
assistants who are eligible to provide
general to auxiliary personnel who
furnish behavioral health services?
Additionally, as a separate example,
we’ve received information from
interested parties that there is a similar
concern regarding urgent care centers
more broadly. These interested parties
note that hospital emergency
departments are often used by
beneficiaries to address non-emergent
urgent care needs that could be
appropriately served in less acute
settings, but where other settings, such
as physician offices, urgent care centers
or other clinics, are not available or
readily accessible. Patients enter EDs to
treat common conditions like allergic
reactions, lacerations, sprains and
fractures, common respiratory illnesses
(for example, flu or RSV), and bacterial
infections (for example, strep throat,
urinary tract infections or foodborne
illness). Conditions like these often can
be treated in less acute settings. We are
interested in system capacity and
workforce issues broadly and are
interested in hearing more on those
issues, including how entities such as
urgent care centers can play a role in
addressing some of the capacity issues
in emergency departments. In
particular, we are interested in feedback
on the following questions, as well as
any other relevant feedback:
• What types of services would
alternative settings to EDs need to offer
to meet beneficiaries’ non-emergent,
urgent care needs?
• Does the current ‘‘Urgent Care
Facility’’ Place of Service code (POS 20)
adequately identify and define the scope
of services furnished in such settings? Is
this place of service code sufficiently
distinct from others such as ‘‘Walk-in
Retail Health Clinic (POS 17) and
‘‘Office’’ (POS 11)? If not, how might
these Place of Service code definitions
be modified?
• Does the existing code set
accurately describe and value services
personally performed by professionals
and costs incurred by the facility in
these settings?
• How might potential strategies to
reduce overcrowding and wait times in
EDs advance equity in access to health
care services?
Lastly, we are seeking comment
regarding Certified Community
Behavioral Health Clinics (CCBHCs).
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Specifically, we are interested in
feedback on the following questions:
++ What kind of services do CCBHCs
provide? Do they provide IOP services,
services for the treatment of substance
use disorders, psychotherapy,
behavioral health integration,
community health integration, or
principal illness navigation services to
patients with either Medicare or another
payer?
++ If CMS outlined how CCBHCs
could bill Medicare under the PFS,
would there be an impact in
underserved areas?
++ To what extent do CCBHCs see
patients with Medicare or who are
dually eligible for Medicare and
Medicaid?
++ To what extent do CCBHCs
employ practitioner types who can
supervise auxiliary personnel and bill
Medicare for their services? For
example, do CCBHCs employ
physicians, clinical psychologists, nurse
practitioners, clinical nurse specialists,
certified nurse midwives and physician
assistants who are eligible to provide
general supervision to auxiliary
personnel who furnish behavioral
health services?
J. Proposals on Medicare Parts A and B
Payment for Dental Services
Inextricably Linked to Specific Covered
Services
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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.’’) That section of the statute
also includes an exception to allow
payment to be made for inpatient
hospital services in connection with the
provision of such dental services if the
individual, because of their underlying
medical condition and clinical status or
because of the severity of the dental
procedure, requires hospitalization in
connection with the provision of such
services. Our regulation at § 411.15(i)
similarly excludes payment for dental
services except for inpatient hospital
services in connection with dental
services when hospitalization is
required because of: (1) the individual’s
underlying medical condition and
clinical status; or (2) the severity of the
dental procedure.
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Fee for service (FFS) Medicare Parts A
and B also make payment 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. In the CY 2023 PFS final rule
(87 FR 69663 through 69688), we
clarified and codified at § 411.15(i)(3)
that Medicare payment under Parts A
and B could be made when dental
services are furnished in either the
inpatient or outpatient setting when the
dental services are inextricably linked
to, and substantially related and integral
to the clinical success of, other covered
services. We also added several
examples of clinical scenarios that are
considered to meet that standard under
§ 411.15(i)(3) and amended that
regulation to add more examples in the
CY 2024 PFS final rule (88 FR 79022
through 79029).
In the CY 2023 PFS final rule, we also
established a process whereby we
accept and consider submissions from
the public (the ‘‘public submission
process’’) to assist us to identify
additional dental services that are
inextricably linked to, and substantially
related and integral to the clinical
success of, other covered services (87 FR
69663 through 69688). Hereafter in this
section we will refer to these services as
dental services that are ‘‘inextricably
linked to other covered services.’’
We also note that the examples
provided in our regulation at
§ 411.15(i)(3)(i) are not exclusive.
Medicare administrative contractors
(MACs) retain discretion to determine
on a claim-by-claim basis whether a
patient’s circumstances do or do not fit
within the terms of the preclusion or
exceptions specified in section
1862(a)(12) of the Act and § 411.15(i).
In the CY 2024 PFS final rule, we
discussed our plans to issue educational
and outreach materials to inform billing
and payment for finalized policies for
dental services. We reiterated our
commitment to review submissions we
receive through the public submissions
process. We also expressed our
intention to continue to engage in
discussions with the public on a wide
spectrum of issues relating to Medicare
payment for dental services that may be
inextricably linked to other covered
services. We also described our
partnership with the Agency for
Healthcare Research and Quality
(AHRQ) to assist us to review available
clinical evidence and consider the
relationship between dental services
and specific covered medical services
and to identify other potential clinical
circumstances in which dental services
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61747
are inextricably linked to other covered
services (88 FR 79029).
In this proposed rule, we (1) describe
recent literature review conducted by
our partner agency, AHRQ, on the
potential connection between sickle cell
disease and hemophilia and dental
services; (2) summarize submissions we
received through the public submission
process for consideration in CY 2025
rulemaking; (3) propose to codify in
section § 411.15(i)(3)(i)(A) additional
policies to permit payment for certain
dental services that are inextricably
linked to other covered services (certain
dental services for patients receiving
dialysis services to treat end-stage renal
disease (ESRD)); (4) request public
comment and information related to
other clinical scenarios that may involve
dental services that are inextricably
linked to other covered services; and (5)
include proposals related to Medicare
billing and payment policy for dental
services. We also include a request for
information regarding oral sleep apnea
appliances.
b. Consideration of Dental Services That
May Be Inextricably Linked to Other
Covered Services
We have partnered with AHRQ to
help us consider the relationship
between dental services and other
specific covered services. Specifically,
AHRQ reviews available clinical
evidence regarding this relationship,
and provides analysis of clinical
scenarios where dental services may be
inextricably linked to other covered
services. To better address the public’s
immediate dental needs, AHRQ
conducted rapid response reports
instead of comprehensive assessments.
With these rapid response reports, we
can better specify which payments can
be made under Medicare Parts A and B
for certain dental services that are
inextricably linked to other covered
services.
Through the public submissions
process for consideration in CY 2024
rulemaking, interested parties
nominated dental services for
individuals living with sickle cell
disease (SCD) or hemophilia, urging us
to consider adding payment for these
services (88 FR 52374). The submissions
included information and references
supporting the inclusion of dental
services that are inextricably linked to,
and substantially related and integral to
the clinical success of, the covered
services used in the treatment of SCD or
hemophilia, because such dental
services serve to mitigate the substantial
risk to the success of the medical
services. Submissions supported the
importance of preventing dental
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lotter on DSK11XQN23PROD with PROPOSALS2
infections among individuals with SCD
to reduce the need for the extensive
procedures that may lead to bleeding
complications and hospitalization. They
also provided information detailing
increased dental caries and periodontal
disease in people with SCD,158 many of
whom lose a number of teeth, which
greatly limits nutrition, general wellbeing, and overall quality of life.
Interested parties recommended that we
adopt a policy to allow payment for
dental services for individuals with
hemophilia (88 FR 79032). They
emphasized that periodic dental care
reduces the risks of dental
complications that may require
hemostatic therapy or oral surgeries
requiring clotting factor replacement
treatment.159 160 161 Many submitters
suggested that maintaining good oral
health leads to improved outcomes for
patients with these two conditions.
Acknowledging the importance of
dental health to overall well-being of
patients with these two types of
diseases, in the CY 2024 proposed rule,
we summarized information provided
by submitters utilizing the public
submission process and solicited
comment on whether certain dental
services are inextricably linked to
covered services in the treatment of SCD
(88 FR 52374). In the CY 2024 PFS final
rule, we noted that several commenters
suggested expanding dental service
coverage for individuals with SCD. They
supported covering dental services
essential for treating SCD, including
hydroxyurea therapy. Another
commenter advocated for expanding
coverage for dental services in cases of
pain crises or dental abscesses in
individuals with SCD. They emphasized
158 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.
159 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.
160 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.
161 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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that improved access to dental care
could improve the quality of life for
individuals with SCD and reduce
healthcare costs by enabling more
suitable treatment options and
decreasing hospital stays. One
commenter questioned the clinical basis
for providing dental benefits for SCD or
hemophilia due to their low prevalence
in the Medicare population. Ultimately,
after consideration of public comments,
we did not expand the examples under
§ 411.15(i)(3)(i) to include additional
covered medical services for SCD. We
concluded that the information
provided by commenters did not
sufficiently demonstrate that dental
services are essential to the clinical
success of hydroxyurea therapy or other
treatments for SCD (88 FR 79032).
Please refer to CY 2024 final rule (88 FR
79031 through 79032) for more detailed
information.
In the CY 2024 PFS proposed rule, we
similarly solicited comments on
hemophilia regarding 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 for individuals with
hemophilia (88 FR 52382). Several
commenters advocated for allowing
Medicare Part A and Part B payment for
dental services for individuals with
hemophilia citing guidelines from
Hemophilia Treatment Centers (HTCs),
the Centers for Disease Control and
Prevention (CDC), and the World
Federation of Hemophilia (WFH). They
emphasized the importance of good oral
health to prevent complications like
gum bleeding and major dental
surgeries, especially in those with
severe/moderate hemophilia. Another
commenter supported this perspective,
noting that regular dental care reduces
the need for clotting factor replacement
therapy. While we acknowledged the
importance of maintaining oral health to
prevent complications such as serious
gum bleeding, especially problematic
for those with hemophilia, we also
reiterated that for the purposes of the
PFS payment policy for dental services
inextricably linked to covered medical
services, our statute and regulations
require that specific evidence supports
the integral connection between dental
services and clinical success in
managing hemophilia-related medical
services, and, therefore, we did not
expand the examples under
§ 411.15(i)(3)(i) to include additional
covered medical services for
hemophilia. Please refer to CY 2024
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final rule (88 FR 79032 through 79033)
for more detailed information.
While interested parties have
suggested the interaction of oral health
care for SCD or hemophilia, we noted
that further research is necessary to find
specific evidence supporting specific
medical services for which dental
services are inextricably linked to their
clinical success. To gain further
understanding of any potential
relationship between dental services
and specific covered SCD or hemophilia
medical services, we again partnered
with researchers at the Agency for
Healthcare Research and Quality
(AHRQ) to review available clinical
evidence regarding the relationship
between dental services and covered
SCD or hemophilia medical services.
AHRQ created two rapid response
reports, which summarized recent
evidence, aiming to inform CMS policy
development related to the possible
linkage between dental services and
treatment modalities and services for
SCD or hemophilia patients. For more
detailed information about the search
strategies and findings, please refer to
the two AHRQ rapid response reports
available at https://effectivehealthcare.
ahrq.gov/products/sickle-cell-dental/
research and https://effectivehealthcare.
ahrq.hgov/products/hemophilia-dental/
research.
1. Consideration of Dental Services That
May Be Inextricably Linked to Covered
Services for the Treatment of Sickle Cell
Disease
As stated in the AHRQ rapid response
report, SCD is a genetic hematologic
disorder affecting approximately
100,000 individuals in the U.S.,162
characterized by abnormal hemoglobin
formation in red blood cells, leading to
complications such as pain, infection,
acute chest syndrome, and stroke.
Hydroxyurea, a commonly used
therapeutic measure,163 which increases
fetal hemoglobin levels, which has a
higher affinity for oxygen than adult
hemoglobin. This therapy can prevent
sickling or curvature of red blood cells
and help SCD patients. SCD patients can
experience dental complications due to
162 Prevention CDC. Learn more about sickle cell
disease, Centers for Disease Control and Prevention.
(Available at https://www.cdc.gov/ncbddd/
sicklecell/.)
163 U.S. Food and Drug Administration. FDA
approves hydroxyurea for treatment of pediatric
patients with sickle cell anemia, U.S. Food and
Drug Administration. (Available at https://
www.fda.gov/drugs/resources-informationapproved-drugs/fda-approves-hydroxyureatreatment-pediatric-patients-sickle-cell-anemia.)
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ischemia,164 including delayed tooth
eruption, enamel disorders, and tongue
cell changes. Ischemic and
inflammation affects enamel, gums, and
jawbones that can cause paresthesia and
tooth pain. In response to a producing
more red blood cells to make up for
anemia, bone marrow expansion can
lead to malocclusion and reduced bone
density.165 166 The AHRQ’s rapid
response report highlights that despite
hydroxyurea’s long-term use to treat
SCD, uncertainty remains regarding
whether dental care before, during, or
after treatment of SCD with hydroxyurea
(and other lesser prescribed treatments)
influences clinical outcomes in patients.
In their rapid response, the Preferred
Reporting Items for Systematic Reviews
and Meta-Analyses (PRISMA) flow
diagram, a flow diagram used in
systematic reviews and meta-analyses
intended to describe findings of the
review, revealed that initially, 762
records were identified from large
databases, and 934 records were
identified from grey literature sources
covering 57 years. Following the
exclusion of ineligible studies, a total of
five unique records were included,
extracted, and evaluated in the rapid
response report. The rapid response
report found that no studies examined
the specific impact of dental care on
SCD treatment outcomes; however, the
rapid response identified three relevant
clinical practice guidelines and two
reviews with recommendations for
dental care for patients with SCD.
According to the rapid response, all
guidelines and reviews highlighted the
importance of preventive dental
measures, with the Sickle Cell Society
in the UK recommending the inclusion
of a hematologist in the dental care team
for SCD patients. However, these
guidelines primarily focused on
managing SCD during dental services
rather than the impact of dental care on
the improvement of SCD treatment
outcomes, which differs from the
regulatory standard in § 411.15(i)(3)(i)
that the dental services are inextricably
linked to, and substantially related and
integral to the clinical success of, other
covered services.
The two rapid reviews with
recommendations highlighted several
key areas of dental management for SCD
164 da Fonseca M, Oueis HS, Casamassimo PS.
Sickle cell anemia: a review for the pediatric
dentist. Pediatr Dent 2007;29(2):159–69. (In eng).
165 Hsu LL, Fan-Hsu J. Evidence-based dental
management in the new era of sickle cell disease:
A scoping review. J Am Dent Assoc
2020;151(9):668–677.e9. (In eng). DOI: 10.1016/
j.adaj.2020.05.023.
166 Kane SF. The effects of oral health on systemic
health. Gen Dent 2017;65(6):30–34. (In eng).
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patients. They emphasized the
importance of preventive dental care to
reduce the risk of oral infections,
periodontal diseases, and major dental
procedures. Additionally, the studies
recommended that a complete blood
count should be evaluated prior to
invasive dental procedures to mitigate
infection risks in SCD patients.167 168
Overall, the findings from the AHRQ
rapid response reports underscore the
gaps in the current literature concerning
the management of oral health care for
individuals with SCD. The body of
evidence evaluating dental services
before, during, or after the treatment of
SCD is lacking in primary clinical data
and is limited to available clinical
practice guidelines and reviews with
recommendations. While guidelines and
reviews have addressed particular
aspects of dental care, such as early
intervention and the importance of
collaboration between dentists and
hematologists, there is an absence of
primary evidence that informed the
potential effect of dental care on SCD
treatment outcomes.
2. Consideration of Dental Services That
May Be Inextricably Linked to Covered
Services for the Treatment of
Hemophilia
As stated in their report, hemophilia
is a rare inherited disorder characterized
by the deficiency or absence of bloodclotting proteins, affecting
approximately 20,000–33,000 males in
the U.S.169 There are three distinct types
of hemophilia (A, B, and C) according
to the specific clotting factor that is
deficient or missing (VIII, IX, and XI,
respectively). Treatment for all three
types of hemophilia is similar but may
vary based on the severity of disease,
and typically involves replacing the
deficient or missing clotting factor.170
Anticoagulation issues in hemophilia
patients can pose challenges for dental
specialists due to the increased risk of
secondary bleeding after oral surgery.171
167 Kawar N, Alrayyes S, Yang B, Aljewari H. Oral
health management considerations for patients with
sickle cell disease. Dis Mon 2018;64(6):296–301. (In
eng). DOI: 10.1016/j.disamonth.2017.12.005.
168 Kakkar M, Holderle K, Sheth M, Arany S,
Schiff L, Planerova A. Orofacial Manifestation and
Dental Management of Sickle Cell Disease: A
Scoping Review. Anemia 2021;2021:5556708. (In
eng). DOI:10.1155/021/5556708.
169 Prevention CfDCa. Hemophilia Treatment.
(https://www.cdc.gov/ncbddd/hemophilia/
treatment.html#:∼:text=The%20best%20way%
20to%20treat,concentrates%2C%20into%20a%
20person’s%20vein.)
170 Ibid.
171 Givol N, Hirschhorn A, Lubetsky A, Bashari D,
Kenet G. Oral surgery-associated postoperative
bleeding in haemophilia patients—a tertiary
centre’s two decade experience. Haemophilia
2015;21(2):234–240. (In eng). DOI: 10.1111/
hae.12573.
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Severe hemophilia patients face
spontaneous bleeding in joints, muscles,
or soft tissues, sometimes lifethreatening, while mild to moderate
cases may experience excessive
bleeding, including after dental
extractions.172
According to the rapid response
reports provided by AHRQ, clotting
factor replacement therapy is the
standard treatment for individuals with
hemophilia. Replacement therapy,
which can be self-administered or given
at a hemophilia treatment center, can be
used to stop a spontaneous bleeding
episode (episodic care), or to prevent
bleeding from occurring (prophylactic
care). However, consistent/prolonged
factor replacement can cause antibody
inhibitor development.173 While
clotting factor replacement therapy
remains the standard treatment for
hemophilia, uncertainty persists
regarding whether dental care before,
during, or after treatment of hemophilia
improves clinical outcomes in patients.
Excessive bleeding, often associated
with invasive or traumatic dental
procedures, poses challenges when
treating patients with hemophilia.
Hence, the timing of dental treatment in
relation to factor replacement therapy
may influence outcomes.
In AHRQ’s rapid response, a total of
1,414 records from large databases and
2,238 records from grey literature,
spanning 73 years, were identified.
Strictly following the exclusion criteria
depicted in the PRISMA diagram, the
response included, extracted, and
evaluated a total of four unique
publications in this rapid response. The
rapid response report identified four
publications: two practice guidelines
and two reviews with
recommendations. The included
publications advised hemophilia
patients to consult hematologists or
hemophilia treatment centers before
dental procedures. They emphasized
interdisciplinary collaboration between
dentists and hematologists for treatment
planning. Included guidelines
recommended performing dental
services during hemophilia treatment
with coagulation factor replacement
therapy. However, all four reviewed
publications mainly addressed
hemophilia A and B, with little mention
172 Oomen I, Camelo RM, Rezende SM, et al.
Determinants of successful immune tolerance
induction in hemophilia A: systematic review and
meta-analysis. Res Pract Thromb Haemost
2023;7(1):100020. (In eng). DOI: 10.1016/
j.rpth.2022.100020.
173 Castaman G, Matino D. Hemophilia A and B:
molecular and clinical similarities and differences.
Haematologica 2019;104(9):1702–1709. (In eng).
DOI: 10.3324/haematol.2019.221093.
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of hemophilia C. Similar to the findings
related to SCD, the body of evidence
evaluating dental services before,
during, or after the treatment of
hemophilia is lacking in primary
clinical data and is currently limited to
available guidelines. These guidelines
emphasize the importance of
professional dental care during
hemophilia treatment with clotting
factor replacement therapy to reduce
bleeding complications, rather than the
inextricable link between certain dental
services and covered services for
hemophilia, which is the regulatory
standard in § 411.15(i)(3)(i) for clinical
scenarios under which payment can be
made for dental services under
Medicare Parts A and B.
After reviewing AHRQ’s
comprehensive rapid reviews for both
SCD and hemophilia, we found the
evidence related to the linkage between
dental services and outcomes for
covered medical services for both SCD
and hemophilia lacking in the current
research and literature. Both rapid
responses noted a limited number of
studies examining the impact of dental
care on outcomes for individuals with
SCD or hemophilia. Currently, the
evidence base does not appear to
support that dental services may be
inextricably linked to covered services
for SCD or hemophilia. Also, the body
of evidence evaluating dental services
before, during, or after the treatment of
SCD and hemophilia lacks primary
clinical data and relies on available
guidelines and reviews. Given limited
information, however, both the SCD and
hemophilia rapid responses support the
need for preventive care and patient
education as essential practices for both
SCD and hemophilia patients to
minimize the likelihood of oral
infections, periodontal disease, and
major dental procedures. In addition,
both rapid response reports recommend
collaborative efforts between dentists,
hematologists, and specialized clinics as
crucial for improved patient care,
despite the lack of primary evidence
informing the potential effect of dental
care on treatment. While both rapid
response reports discuss their findings
on the importance of a multidisciplinary
approach, both rapid response reports
also found that the current reviews and
guidelines do not address dental care as
a standard of care that is inextricably
linked to hemophilia or SCD treatment.
Instead, their focus was on managing
the respective conditions during dental
services, not on the inextricable linkage
between the dental and medical
services.
In conclusion, interested parties,
including industry organizations, public
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commenters, and organizations
submitting through the public
submissions process, requested that
CMS consider the conditions of SCD
and hemophilia for the purposes of the
Medicare Parts A and B payment policy
for dental services that are inextricably
linked to other covered services. As part
of our commitment to exploring the
inextricable link between dental and
covered services associated with SCD
and hemophilia, we partnered with
AHRQ to generate comprehensive rapid
responses on these topics. However, the
AHRQ’s rapid response reports show
that the current evidence base does not
appear to support that dental services
may be inextricably linked to services
for SCD or hemophilia within the
meaning of the standard at
§ 411.15(i)(3), and we are not proposing
to add these conditions to our
regulation. Moreover, the findings of the
AHRQ rapid response reports highlight
that this area merits further study by
researchers and industry in order to
further explore potential connections
between dental services and improved
outcomes for individuals with SCD or
hemophilia. Given the new and
evolving therapies and treatments in
this space, we will consider conducting
additional evaluations as new studies
are carried out to examining the impact
of dental services on SCD and
hemophilia outcomes and will take any
future studies into consideration.
We continue to seek clinical evidence
demonstrating the integral connection
between dental services and other
covered services for SCD and
hemophilia, and we welcome any
comments or literature regarding these
two conditions. We are not proposing to
amend § 411.15(i)(3)(i) as we have not
identified additional dental services that
are inextricably linked to certain
services associated with SCD or
hemophilia. However, we remain open
to considering any such services
identified by public commenters, and, if
sufficient evidence is presented, we may
consider adding such services to our
regulations in the final rule. In addition,
we encourage interested parties to
supply additional submissions for
consideration in future PFS rulemaking
through the public submission process,
which may include relevant medical
evidence, peer-reviewed literature,
clinical guidelines, or supporting
documentation as described in section
II.J.1.c. of this proposed rule.
c. Submissions Received Through
Public Submission Process
As we have in the CY 2023 and CY
2024 PFS final rules, we continue to
encourage interested parties to engage
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with us regularly and to submit
recommendations through our public
submissions process for our
consideration of additional clinical
scenarios where dental services may be
inextricably linked to covered services
under § 411.15(i)(3)(i). Through our
annual public submissions process,
interested parties should provide
clinical evidence and other
documentation to support their
recommendations (87 FR 69685). We are
using the PFS annual rulemaking
process to discuss public submissions
and to consider whether the clinical
scenario described in the submissions
should be added to § 411.15(i)(3)(i) as an
example of a circumstance where
payment can be made for dental services
inextricably linked to other covered
services. Using our annual notice and
comment rulemaking process to discuss
submitted recommendations allows the
public to comment and submit further
medical evidence and important
feedback 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.
We review clinical evidence included
in submissions and public comments in
rulemaking, as well as information and
analysis provided by AHRQ in rapid
response reports, to assess whether
there is an inextricable link between
certain dental services and certain
covered services. We would find that
there is an inextricable link where the
standard of care for a service is such
that the practitioner would not proceed
with the procedure or service without
performing the dental service(s), for
example, 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. As such,
documentation accompanying
recommendations should include
medical evidence to support that certain
dental services are inextricably linked to
certain covered services. Specifically, as
we specified in the CY 2023 PFS final
rule, we request that the medical
evidence included in submissions
through the public submissions process
should:
(1) Provide support that the provision
of certain dental services leads to
improved healing, improved quality of
surgery outcomes, and the reduced
likelihood of readmission and/or
surgical revisions because an infection
has interfered with the integration of the
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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 other
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).
This evidence should include at least
one 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).
Submissions should focus on the
inextricably linked relationship between
dental services and other services
necessary to diagnose and treat the
individual’s underlying medical
condition and clinical status, and
whether it would not be clinically
advisable to move forward with the
other covered services without
performing certain dental services. To
be considered for purposes of CY 2026
PFS rulemaking, submissions through
our public submissions process should
be received by February 10, 2025, via
email at
MedicarePhysicianFeeSchedule@
cms.hhs.gov. To facilitate processing,
interested parties should include the
words ‘‘dental recommendations for CY
2026 review’’ in the subject line of their
email submission. We continue to stress
to submitters that recommendations
must include at least one of the types of
evidence listed earlier. We further note
that we may also consider
recommendations that are submitted as
public comments during the comment
period following the annual publication
of the PFS proposed rule.
We thank all those who submitted
recommendations for additional clinical
scenarios for which they believe
Medicare payment for dental services
will be consistent with the policies we
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codified at § 411.15(i)(3)(i), under which
Medicare payment may be made for
dental services when they are
inextricably linked to other covered
services. We received thirteen
submissions from various organizations
and individuals on or before February
10, 2024. Several submitters represented
dozens or hundreds of other
organizations in making these
recommendations. We received one
submission after the deadline that
presented nominations for clinical
scenarios addressed by other submitters,
and a proposal outside the scope of
clinical scenarios where dental services
may be inextricably linked to covered
medical services under § 411.15(i)(3)(i).
One submitter recommended that oral
health care is essential to the success of
treatments for individuals with sickle
cell disease and other hematologic
disorders. The submitter asserted that
providing appropriate and timely dental
care is a crucial component for the
successful treatment of many
hematologic diseases, including SCD,
hemophilia, and many blood cancers,
such as acute myeloid leukemia, acute
lymphoblastic leukemia, chronic
lymphocytic leukemia, chronic myeloid
leukemia, and multiple myeloma. The
submitter noted that we finalized that
payment can be made for certain dental
services prior to or contemporaneously
with chemotherapy, CAR T-Cell
therapy, and the administration of highdose bone-modifying agents (antiresorptive therapy), when used in the
treatment of cancer. The evidence
submitted showed that among
individuals with a sickle cell crisis,
those with dental infections were 72%
more likely to be admitted to the
hospital than those without dental
infections. The same submitter also
requested that we consider payment of
dental services following organ
transplantations (including bone
marrow or hematopoietic stem cell
transplantation (HSTC)) because
maintenance of oral hygiene after HSCT
minimizes the severity of oral and
dental infections, which is important
because chronic graft versus host
disease (cGVHD) is common following
allogeneic HSCT. The submitter stated
that frequent dental evaluations of
patients with cGVHD are critical
because of the increased rate of dental
caries associated with this disease;
furthermore, gingivitis and periodontal
disease should be monitored and
managed appropriately to avoid
additional infection. Finally, the
submitter also stated that multiple tooth
extractions without replacement of
dentition leave patients with a poor
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61751
capacity to eat and may negatively
impact the success of the transplant and
quality of life. This submitter also
recommended including cell and gene
therapy for SCD as a clinical treatment
scenario for future consideration of
potentially inextricably linked dental
services.
Another submitter asserted that
patients frequently present with
complications extending three years or
more following the direct treatment of
not only head and neck cancers but also
other cancer types. The submitter also
asserted that a comparable trend may be
seen in patients experiencing
complications following anti-resorptive
drug therapy, for non-cancer-related
conditions. They recommended that
payment be available for specific dental
services during a minimum of 2 years
post-treatment for head and neck cancer
and up to 5 years for those who have
received radiotherapy. They
emphasized the current evidence and
literature as supporting the provision of
Medicare payment for a minimum of 2
years, with the understanding that some
patients may require dental or oral
healthcare beyond this period due to
delayed or late-onset complications, and
that the timeline for the emergence of
oral or dental complications posttreatment is not uniformly linear and
can significantly vary among patients.
They also stated that literature supports
the extension of Medicare payment to
include certain dental services
furnished post-anti-resorptive therapy,
when used in the treatment of cancer for
at least two years following treatment.
Lastly, this submitter stated there is an
inextricable risk of the development of
severe dental and oral complications,
such as osteoradionecrosis/medicationrelated osteonecrosis of the jaw, in
patients who have undergone the
specific treatments for which we have
identified certain inextricably linked
dental services. They suggested that
once patients receive these treatments,
patients are perpetually at risk for
developing such complications and
recommended that current Medicare
payment for dental services should align
with the long-term healthcare needs of
these patients.
We are not accepting the commenters’
suggestion to include specific time
limits within the exception in
§ 411.15(i)(3). We note again that MACs
have the flexibility to determine on a
claim-by-claim basis whether payment
can be made for certain dental services
for beneficiaries, such as those receiving
other immunotherapies that may
involve a lymphodepleting component,
consistent with § 411.15(i)(3). That
regulation states the general rule that
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Medicare Parts A and B payment can be
made for certain dental services that are
inextricably linked to, and substantially
related and integral to the clinical
success of, covered services; and then
provides a non-exclusive list of
examples of clinical scenarios under
which payment can be made. Thus, a
MAC has discretion to decide on a caseby-case basis that payment can be made
for certain dental services in other
circumstances not specifically
addressed under § 411.15(i)(3)(i)
Several submitters recommended that
we provide for payment of medically
necessary dental services for individuals
with autoimmune diseases who are
initiating or undergoing
immunosuppressive or
immunomodulator therapy
(‘‘immunosuppressive therapy’’). They
stated that immunosuppressive therapy
can be severely complicated and
compromised by oral/dental disease and
conditions. The submitters provided
references to numerous clinical studies
and other supporting documentation in
support of dental services in these
clinical circumstances being
inextricably linked to
immunosuppressive therapies for which
payment may be made in accordance
with § 411.15(i)(3). They noted that
while higher dosing is used for cancer
chemotherapy and organ transplant
rejection prevention, the therapy’s
duration is generally much shorter than
when used in autoimmune disease
therapy and that the longer-term
duration of use for managing symptoms
of autoimmune disease can expose
patients to ongoing serious risk of
complicating infections for decades.
They relayed that the American College
of Rheumatology states it is vital for
patients to receive appropriate dental
evaluation and prompt treatment so
they can continue their immune
suppressant medications. The submitter
explained that dental infections could
spread more easily, and therefore faster,
when host immunity is compromised by
immunosuppressing/
immunomodulating drugs via three
pathways for the bacteria to spread:
locally through facial spaces, through
the bloodstream, and by aspiration.
They stated that outcomes similar to
systemic infection or sepsis and other
complications can follow for those
receiving immunosuppressive therapy
to treat autoimmune diseases. They
recommended immunosuppressive
therapy to treat autoimmune diseases
should not proceed until a dental or oral
exam is performed to address the oral
complications and/or clear the patient
of an oral or dental infection. We
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discuss these recommendations and
supporting evidence in section II.J.4. of
this proposed rule.
Several submitters recommended that
dental treatments can be integral to the
clinical success of covered nephrologyrelated medical services including
services received by beneficiaries who
are immunocompromised by end-stage
renal disease (ESRD), chronic kidney
disease (CKD), other renal diseases, as
well as kidney transplant candidates
maintained on immunosuppressive
medications. They stated that all of
these patients are at increased risk of
infection, complications, and
malnutrition from dentally sourced
pathogens. Submitters stated that
Medicare ESRD beneficiaries on dialysis
are at greater risk for developing
complications such as cardiovascular
conditions, malnutrition, anemia, and
infections, making dental services more
critical to the success of kidney care
treatments. They further stated that pretransplantation dental care involves
eliminating possible sources of oral
infection that can lead to a systemic
infection following transplant and that
without access to dental services,
individuals on dialysis may not qualify
for kidney transplantation or may have
severe complications after the
transplant. One of the submitters noted
that dialysis clinicians report that many
bloodstream infections (BSI) begin with
bacteria in the mouth and that regular
dental visits could have a positive
impact on reducing BSI. They added
that the Society for Vascular Surgery has
noted that transient bacteremia from
dental infections can seed hemodialysis
access grafts. Among strategies to
prevent infection of vascular grafts,
recommended preoperative measures
include identifying and treating remote
site infections, including dental sites.
We discuss these recommendations and
supporting evidence in section II.J.2. of
this proposed rule.
More than half of the submissions
expressed support for almost identical
proposals from a couple of other
submitters, recommending that dental
services are inextricably linked to
covered medical services used for the
treatment of Medicare beneficiaries with
diabetes. They agreed that the delivery
of appropriate dental services in
accordance with clinical guidelines and
standard of care is substantially related
and integral to the optimal outcome of
these covered medical services. They
offered clinical studies documenting
that treatment of oral infections, such as
periodontitis and its related
inflammation, meaningfully improves
the treatment and management of
diabetes. They stated, by contrast, the
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absence of treatment of chronic dental
infections complicates covered medical
treatment for the management of
diabetes and exacerbates insulin
resistance, worsens glycemic control,
and other diabetes related
complications. They noted that the
relationship between oral diseases and
diabetes mellitus is complex. Diabetes is
known to increase the risk and severity
of oral diseases, such as periodontitis
(gum inflammation and bone loss), tooth
loss, dry mouth, and oral fungal
infections. Additionally, oral diseases
are documented as affecting blood
glucose control and contributing to the
development of diabetes complications,
such as retinopathy, neuropathy,
cardiovascular disease, and kidney
disease. They believe reciprocal
management of glycemic control and
periodontal disease decreases risk for
and actual cases and severity of diabetes
and periodontal disease. We discuss
these recommendations and the
supporting clinical evidence in section
II.J.3 of this proposed rule.
2. Proposed Additions to Current
Policies Permitting Payment for Dental
Services Inextricably Linked to Other
Covered Services
We have received information and
requests from interested parties,
including entities submitting
information through the public
submissions process as well as
organizations providing comments in
response to prior rulemaking efforts,
that an inextricable linkage exists
between dental services and dialysis
treatment services for individuals
diagnosed with end-stage renal disease
(ESRD) who are receiving dialysis
services, particularly those experiencing
comorbidities. Commenters and
submitters have stated that dental
treatment is inextricably linked and
integral, and substantially related to the
clinical success and outcomes of
covered dialysis medical services.
In the CY 2024 PFS final rule, we
stated that commenters had provided
comments in response to the CY 2024
PFS proposed rule supporting the
coverage of annual dental examinations,
and treatment as clinically indicated, for
individuals with chronic kidney disease
and ESRD. The commenters stated that
chronic immunosuppression increases
the risk of dental infections leading to
potentially deadly complications
including BSI, peritoneal dialysisassociated peritonitis, and the
exacerbation of chronic cardiovascular
conditions. They also stated that when
established by patient-specific medical
and dental parameters, dental services
can be unquestionably integral to the
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outcome of covered medical procedures.
We thanked the commenters for the
information they submitted regarding
these suggestions; however, at that time,
commenters did not provide sufficient
evidence to support an inextricable link
between certain dental services and
certain covered services for chronic
kidney disease and ESRD (88 FR 79034).
Additionally, submitters provided
information through the public
submissions process as described in
section II.J.1.c. of this proposed rule for
our consideration in CY 2025
rulemaking. The submitters stated that
there is a connection between dental
services to identify and address dental
or oral infections and covered medical
services for individuals receiving
dialysis in the treatment of ESRD.
ESRD is a medical condition in which
a person’s kidneys successively
experience loss of functionality on a
permanent basis, leading to the need for
a regular course of long-term dialysis or
a kidney transplant to maintain life.174
Chronic kidney disease (CKD) is a
progressively debilitating disease and is
marked by the presence of kidney
damage or reduction in the kidneys’
filtration rate. CKD is a state of
progressive loss of kidney function, in
that the disease worsens over time and
cannot be reversed, ultimately resulting
in the need for renal replacement
therapy, generally dialysis or
transplantation.175 The Kidney Disease
Improving Global Outcomes (KDIGO)
Foundation established guidelines that
define five stages of CKD using kidney
damage markers, including factors that
determine proteinuria (level of protein
in the urine) and glomerular filtration
rate (level of kidney function/filtration)
in its KDIGO 2012 Clinical Practice
Guideline for the Evaluation and
Management of Chronic Kidney
Disease.176 Chronic kidney disease is
generally defined as the presence of two
factors (glomerular filtration rate [GFR]
less than 60 mL/min and albumin
greater than 30 mg per gram of
creatinine) along with abnormalities of
kidney structure or function for greater
than three months. Stage 5 of CKD is
labeled end-stage renal disease (ESRD)
with a GFR of less than 15 mL/min.177
According to the NIH, more than
174 https://www.cms.gov/medicare/coordinationbenefits-recovery/overview/end-stage-renal-diseaseesrd.
175 https://www.ncbi.nlm.nih.gov/books/
NBK535404/.
176 https://kdigo.org/wp-content/uploads/2017/
02/KDIGO_2012_CKD_GL.pdf.
177 https://www.ncbi.nlm.nih.gov/books/
NBK499861/.
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500,000 people in the United States live
with ESRD.178
Per the American Academy of Family
Physicians, individuals with ESRD are
typically referred to nephrologists for
the development of treatment plans.
Collectively the various modalities
utilized to replicate kidney function are
referred to as renal replacement therapy
(RRT). Most ESRD patients are treated
with dialysis, regardless of whether
transplantation ultimately occurs.
Generally, kidney transplantation
typically yields the best patient
outcomes; however, not all patients
with ESRD are eligible for or able to
undergo transplantation, and therefore
continue dialysis treatment.179
Standards of medical care for CKD
outline the need for monitoring for signs
of progression of the disease and early
referral to specialists for RRT.180
Dialysis is generally supplied via two
primary modes: hemodialysis or
peritoneal dialysis. In hemodialysis,
blood is filtered through a dialyzer,
outside of the body. A dialyzer is
sometimes referred to as an ‘‘artificial
kidney.’’181 To access the circulatory
system, several access points may be
placed and utilized, including an
arteriovenous (AV) fistula, AV graft, and
in some cases a central venous
catheter.182 183 184 In peritoneal dialysis,
a fixed catheter is placed in the
abdomen, and dialysis solution is
administered into the abdomen. The
solution absorbs wastes and excess fluid
from the patient’s body. 185 186
Submissions we received through the
public submissions process for
consideration in CY 2025 rulemaking
provided information regarding the
potential linkage between dental
services and specific covered medical
services associated with ESRD and
dialysis including:
• CPT codes 36901–36906: Dialysis
circuit procedures;
• CPT codes 90935, 90937, 90940:
Hemodialysis procedures;
178 https://www.ncbi.nlm.nih.gov/books/
NBK499861/.
179 Am Fam Physician. 2021;104(5):493–499.
https://www.aafp.org/pubs/afp/issues/2021/1100/
p493.html.
180 https://pubmed.ncbi.nlm.nih.gov/29763036/.
181 https://www.niddk.nih.gov/healthinformation/kidney-disease/kidney-failure/
hemodialysis.
182 https://www.ncbi.nlm.nih.gov/books/
NBK563296/.
183 https://www.mayoclinic.org/tests-procedures/
hemodialysis/about/pac-20384824.
184 https://www.cdc.gov/dialysis/patient/.
185 https://www.mayoclinic.org/tests-procedures/
peritoneal-dialysis/about/pac-20384725
186 https://www.niddk.nih.gov/healthinformation/kidney-disease/kidney-failure/
peritoneal-dialysis.
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• CPT code 90961: Physician or other
qualified healthcare professional visits
for ESRD;
• CPT codes 90989–90999: Other
dialysis procedures; and,
• DRG code 872: Hospitalization for
septicemia or severe sepsis.
We note that Medicare provides
coverage for individuals with ESRD,
regardless of age, when certain
requirements are met.187
We also note that dialysis procedures
may be utilized for individuals who do
not have ESRD in the treatment of acute
intoxication or poisoning. For example,
in the case of a patient experiencing
poisoning, dialysis hemoperfusion may
be employed, which passes the blood
through a column packed with granules
that include a resin that act as
absorbents. In this procedure,
physicochemical properties of an
absorbent are used to remove toxins.
Conversely, in hemodialysis utilized in
the treatment of ESRD, there is a
concentration gradient between the
blood and the solvent across the dialysis
membrane.188 We note that the patient
accessing dialysis treatment for the
treatment of acute intoxication or
poisoning would not present with the
same diagnostic profile, treatment
needs, nor face the same risks of
immunodeficiency and infection as
individuals with ESRD as described
below.189
Periodontal diseases and dental caries
are the main chronic infectious diseases
of the oral cavity. Periodontal diseases
include a group of chronic inflammatory
diseases that affect the periodontal
supporting tissues of teeth and
encompass destructive and
nondestructive diseases. Gingivitis is
inflammation of the soft tissue without
apical migration of the junctional
epithelium. It is a reversible,
nondestructive disease that does not
involve loss of periodontal tissues.
Periodontitis is inflammation of the
periodontium that is accompanied by
apical migration of the junctional
epithelium, leading to destruction of the
187 https://www.cms.gov/medicare/coordinationbenefits-recovery/overview/end-stage-renal-diseaseesrd.
188 Durakovic Z. Combined hemoperfusion and
hemodialysis treatment of poisoning with
cholinesterase inhibitors. Korean J Intern Med. 1993
Jul;8(2):99–102. doi: 10.3904/kjim.1993.8.2.99.
PMID: 8031730; PMCID: PMC4532091. https://
www.ncbi.nlm.nih.gov/pmc/articles/PMC4532091.
189 Ouellet G, Bouchard J, Ghannoum M, Decker
BS. Available extracorporeal treatments for
poisoning: overview and limitations. Semin Dial.
2014 Jul;27(4):342–9. https://pubmed.ncbi.
nlm.nih.gov/24697909/.
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connective tissue attachment and
alveolar bone loss.190
Periodontitis serves as a prime
example of a disrupted balance between
the local microbiome and the host’s
inflammatory response, a condition
known as dysbiosis. Although the
inflammatory response is ostensibly
triggered to manage the microbial threat,
it proves to be ineffective and
inadequately regulated in individuals
prone to the condition. This leads to the
inflammatory destruction of the
periodontium, which encompasses the
tissues that encase and support the
teeth, including the gingiva, periodontal
ligament, and alveolar bone. Without
appropriate treatment, this disease can
progress to tooth loss, adversely
affecting chewing, appearance, and
overall quality of life.191
In 2017, the American Academy of
Periodontology (AAP) and the European
Federation of Periodontology (EFP) copresented the 2017 Classification of
Periodontal and Peri-Implant Diseases
and Conditions. This disease
classification framework serves to guide
treatment planning for periodontitis and
aims to support customized approaches
to patient care. The revised
classification includes a multidimensional staging and grading system
for periodontitis classification, a
recategorization of various forms of
periodontitis, and a classification for
peri-implant diseases and conditions.192
Individuals with ESRD experience
compromised immune systems as the
immune system and the kidneys are
closely integrated and interdependent.
In healthy individuals, the kidneys
contribute to immune homeostasis and
regulation, while components of the
immune system mediate many acute
forms of renal disease and play a central
role in the progression of chronic
kidney disease. A dysregulated immune
system can have either direct or indirect
renal effects.193 Moreover, uremia, the
buildup of waste products in the blood
that occurs as a result of declining or
decreasing kidney function, can lead to
inflammation and reduction in the
190 Albandar, J.M. (2005). Epidemiology and risk
factors of periodontal diseases. Dent Clin North Am,
49(3), 517–532, v-vi. doi:10.1016/
j.cden.2005.03.003.
191 Hajishengallis, G., & Chavakis, T. (2021). Local
and systemic mechanisms linking periodontal
disease and inflammatory comorbidities. Nature
Reviews Immunology, 21(7), 426–440. doi:10.1038/
s41577–020–00488–6.
192 https://www.perio.org/wp-content/uploads/
2019/08/Staging-and-Grading-Periodontitis.pdf.
193 Tecklenborg J, Clayton D, Siebert S, Coley SM.
The role of the immune system in kidney disease.
Clin Exp Immunol. 2018 May;192(2):142–150. doi:
10.1111/cei.13119. Epub 2018 Mar 24. PMID:
29453850; PMCID: PMC5904695.
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immune system’s ability to function as
evidenced by an increased risk of viralassociated cancers, increased
susceptibility to infections, and
decreased vaccination responses in
patients with ESRD.194 ESRD is also
characterized by diminished endocrine
and metabolic functions of the kidney
with subsequent retention and
accumulation of toxic metabolites.195
Additionally, the presence of indwelling
catheters and grafts utilized for the
administration of dialysis, malnutrition,
dysregulated inflammation, and
acquired immune dysfunction due to
uremia contribute to the immune
deficiency in ESRD and increase
susceptibility to infection.196 Notably,
infection is the second leading cause of
death in hemodialysis patients.197 198
Several submitters providing
information through the public
submissions process stated that
comorbidities frequently occur in the
ESRD patient population and can cause
complications for the patient,
potentially jeopardizing the outcomes of
the dialysis treatment. For example,
submitters stated that comorbid diabetes
can result in clinical complications for
individuals receiving dialysis services
in the treatment of ESRD, stating that
periodontitis can worsen blood glucose
control in diabetics by increasing levels
of inflammatory mediators and may
interfere with insulin, resulting in
clinical complications. Additionally,
periodontitis is associated with oral
health-related quality of life in
individuals with ESRD. One study
evaluated whether periodontitis may be
independently associated with oral
health-related quality of life (OHRQoL)
in individuals with ESRD. Researchers
assessed 180 adults with ESRD and
evaluated for impacts on various
domains, and found that periodontitis
exerts an influence on OHRQoL in
194 Betjes MG. Immune cell dysfunction and
inflammation in end-stage renal disease. Nat Rev
Nephrol. 2013 May;9(5):255–65. doi: 10.1038/
nrneph.2013.44. Epub 2013 Mar 19. PMID:
23507826. https://pubmed.ncbi.nlm.nih.gov/
23507826/.
195 Costantinides F, Castronovo G, Vettori E,
Frattini C, Artero ML, Bevilacqua L, Berton F,
Nicolin V, Di Lenarda R. Dental Care for Patients
with End-Stage Renal Disease and Undergoing
Hemodialysis. Int J Dent. 2018 Nov
13;2018:9610892. doi: 10.1155/2018/9610892.
PMID: 30538746; PMCID: PMC6258100.
196 https://www.ncbi.nlm.nih.gov/pmc/articles/
PMC7404977/.
197 U.S. Renal Data System. USRDS 2015 Annual
Data Report: Atlas of End-Stage Renal Disease in the
United States, Bethesda, National Institutes of
Health, National Institute of Diabetes and Digestive
and Kidney Diseases, 2015.
198 Dalrymple LS, et al. Infection-related
hospitalizations in older patients with ESRD. Am.
J. Kidney Dis. 2010;56:522–530. doi: 10.1053/
j.ajkd.2010.04.016.
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individuals with ESRD, with a more
severe condition impacting different
domains.199 Moreover, a prospective
cohort study aimed to determine the
association between an index of
radiographically assessed oral health,
Panoramic Tomographic Index (PTI),
and cardiovascular and all-cause
mortality, major adverse cardiovascular
events (MACEs) and episodes of
bacteremia and laboratory
measurements during a three-year
prospective follow-up in chronic kidney
disease (CKD) stage 4–5 patients not on
maintenance dialysis at baseline. The
study showed that radiographically
assessed and indexed dental health is
independently associated with all-cause
and cardiovascular mortality and
MACEs in CKD stage 4–5 patients
transitioning to maintenance dialysis
and renal transplantation during followup (but not with the incidence of
bacteremia).200
Submitters providing information
through the public process also stated
that BSI, poor glycemic control, and
other complications arising from dental
infection can jeopardize the clinical
success of medical therapies employed
to manage ESRD. Research provided by
submitters described that issues and
changes in the mouth and oral cavity,
such as periodontitis and other
consequences of poor oral health,
frequently occur in patients with CKD
and may contribute to increased
morbidity and mortality because of
systemic consequences such as
inflammation, infections, protein-energy
wasting, and atherosclerotic
complications.201
Several submitters also stated that
addressing oral health issues, including
identifying and resolving dental
infections through the provision of
dental and oral services, can be
inextricably linked and integral and
related to the clinical success of
Medicare covered dialysis services for
the treatment of ESRD. The submitters
199 Oliveira, L.M., Sari, D., Schoffer, C., Santi,
S.S., Antoniazzi, R.P., & Zanatta, F.B. (2020).
Periodontitis is associated with oral health-related
quality of life in individuals with end-stage renal
disease. Journal of Clinical Periodontology, 47(3),
319–329. doi:10.1111/jcpe.13233.
200 Jarvisalo, M.J., Jokihaka, V., Hakamaki, M.,
Lankinen, R., Helin, H., Koivuviita, N.S., . . .
Metsarinne, K. (2021). Dental health assessed using
panoramic radiograph and adverse events in
chronic kidney disease stage 4–5 patients
transitioning to dialysis and transplantation-A
prospective cohort study. PLOS ONE, 16(9),
e0258055. doi:10.1371/journal.pone.0258055.
201 Harun Akar, Gulcan Coskun Akar, Juan Jesus
Carrero, Peter Stenvinkel, and Bengt Lindholm.
Systemic Consequences of Poor Oral Health in
Chronic Kidney Disease Patients, Clin J Am Soc
Nephrol 6: 218–226, 2011. doi: 10.2215/
CJN.05470610.
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stated that the consequences of poor
oral health are worse for ESRD patients
than the general population due to
ESRD patient characteristics such as
advanced age, higher prevalence of
comorbid diabetes, polypharmacy, and
impaired immune function, and that
medically necessary dental care may
improve the clinical success of the
dialysis services.
A few submitters supplied a general
position paper on the need for dental
care and services in the ESRD patient
population receiving dialysis services,
describing the unique risks for
individuals with ESRD and the
increased risk of infection from oral
sources. Specifically, the position paper
states that ‘‘oral diseases represent a
potential and preventable cause of poor
health outcomes in people with ESRD
due to their relation to infection,
inflammation, and malnutrition. Oral
health represents a potential
determinant of health outcomes in
patients with end-stage renal diseases
(ESRD).’’202 Several submitters also
provided a cohort outcomes study of
675 randomly selected individuals
receiving peritoneal dialysis services.203
The study outcomes described that
‘‘poor oral health was associated with
lower educational levels, diabetes, older
age, marriage, and worse nutritional
indicators (including lower timeaveraged serum albumin and phosphate
concentrations).’’204
The research further isolated that poor
oral health is independently associated
with an increased risk of peritonitis, an
infection of the peritoneum where the
peritoneal access graft is placed, and
mortality in patients receiving
peritoneal dialysis. The authors describe
that ‘‘after adjusting for age, sex,
comorbidities, serum albumin, shared
frailty by study sites, and PD vintage,
poor oral health was associated with
increased risks of peritonitis (adjusted
hazard ratio [HR] = 1.45, 95 percent
confidence interval [CI]: 1.06–2.00) and
all-cause mortality (adjusted HR = 1.55,
95 percent CI: 1.04–2.32) but not
hemodialysis (HD) transfer (adjusted HR
= 1.89, 95 percent CI: 0.87–4.10)
compared to participants with good oral
202 Costantinides F, Castronovo G, Vettori E,
Frattini C, Artero ML, Bevilacqua L, Berton F,
Nicolin V, Di Lenarda R. Dental Care for Patients
with End-Stage Renal Disease and Undergoing
Hemodialysis. Int J Dent. 2018 Nov
13;2018:9610892. doi: 10.1155/2018/9610892.
PMID: 30538746; PMCID: PMC6258100.
203 Sirirat Purisinsith, Patnarin Kanjanabuch,
Jeerath Phannajit, Bruce Robinson, Kriang
Tungsanga, et al. ‘‘Oral Health-Related Quality of
Life, A Proxy of Poor Outcomes in Patients on
Peritoneal Dialysis.’’ doi: https://doi.org/10.1016/
j.ekir.2022.07.008 (August 5, 2022).
204 Ibid.
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health.’’ Furthermore, the study
explained that ‘‘poor oral health status
was present in one-fourth of peritoneal
dialysis patients and was independently
associated with a higher risk of
peritonitis and death.’’205 Moreover,
submitters provided information that
suggests that patients with ESRD
receiving hemodialysis services and
receiving preventive oral and dental
services experience increased survival
while those not receiving dental
services were associated with increased
mortality. A prospective cohort
outcomes study of 4,205 hemodialysis
patients assessed the impact of dental
health on mortality from 2010 to 2012.
The study described that ‘‘in adults
treated with hemodialysis, poorer dental
health was associated with early death,
whereas preventive dental health
practices were associated with longer
survival.’’206
Additionally, in a systematic review
supplied by several submitters, studies
show that patients on RRT (for example
hemodialysis, peritoneal dialysis, and/
or transplantation) experience a high
prevalence of dental caries, common
chronic infection resulting from toothadherent cariogenic bacteria.207 The
observational data presented in the
review suggests a link between oral
health and mortality in patients on
RRT.208 The review highlighted the
need for further research in this area but
also stated that improved,
multidisciplinary, patient-centered
dental care concepts are required to
support dental and overall oral health in
individuals on RRT.
Several submitters also noted that the
Society for Vascular Surgery has stated
that transient bacteremia from dental
infections can seed hemodialysis access
grafts. Among strategies to prevent
infection of vascular grafts,
recommended preoperative measures
include identifying and treating remote
site infections, including dental or oral
sites of infection.209 210 Statements
205 Ibid.
206 See, e.g., Palmer S.C., Ruospo M., Wong G., et
al. Oral-D study investigators. Dental health and
mortality in people with end-stage kidney disease
treated with hemodialysis: a multinational cohort
study. American Journal of Kidney Diseases.
2015;66:666–676.
207 https://www.ncbi.nlm.nih.gov/books/
NBK551699/.
208 Deborah Kreher et.al., Prevalence of Dental
Caries in Patients on Renal Replacement Therapy—
A Systematic Review J. Clin. Med. 2023, 12, 1507.
https://doi.org/10.3390/jcm12041507.
209 Surgical Site Infection Toolkit, CDC, SSI
Toolkit Activity C: ELC Prevention Collaboratives
(cdc.gov).
210 Pear S, Patient Risk Factors and Best Practices
for Surgical Site Infection Prevention, https://
www.halyardhealth.com/wp-content/uploads/
patient_risk_factors_best_practices_ssi.pdf.
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regarding best practices for managing
infection control advise that sources of
infection, including those within the
oral cavity, should be addressed in
order to minimize the risk of broader
infection in the ESRD patient receiving
hemodialysis.211
In conclusion, the evidence base
indicates that evaluation for and
treatment of oral infection leads to
improved outcomes and reduced risk of
mortality for individuals with ESRD
receiving covered dialysis services.
In the CY 2023 PFS final rule, we
agreed with commenters that there is
clinical evidence to support that
medically necessary dental care may
advance the clinical success of organ
transplants and finalized that payment
can be made under Medicare Parts A
and B for dental services such as dental
examinations, including necessary
treatment, performed as part of a
comprehensive workup prior to organ
transplant surgery and medically
necessary diagnostic and treatment
services immediately necessary to
eliminate or eradicate the infection or
its source that are provided before
transplantation because such services
are inextricably linked to, and
substantially related and integral to the
clinical success of, the organ transplant
procedure (87 FR 69676).
Furthermore, we stated that we
appreciated commenters’ feedback
regarding those individuals who are
awaiting organ transplantation and the
commenters’ request that Medicare
provide payment for medically
necessary dental services prior to
transplantation. We described that in a
case where an individual is awaiting
organ transplantation, we believe that it
is appropriate for Medicare to provide
payment for, including but not limited
to, an oral or dental examination, and
medically necessary diagnosis and
treatment for only those services that are
considered immediately necessary to
eliminate or eradicate the infection or
its source prior to the organ transplant
(87 FR 69676).
In consideration of research and
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 dialysis services
for individuals with ESRD, we believe
that dental services to diagnose and
treat infection prior to dialysis services
in the treatment of ESRD represent a
clinically analogous scenario to dental
services for which Medicare payment
under Parts A and B is currently
permitted when furnished in the
211 Ibid.
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inpatient or outpatient setting, such as
prior to organ transplant. The clinical
evidence supports that the medically
necessary dental care may similarly
advance the clinical success of dialysis
services in the treatment of ESRD
because an oral or dental infection can
present substantial risk to the success
and outcomes of these procedures
(including the risk of systemic infection,
BSI, sepsis, and death).
As such, we believe that if a patient
requiring dialysis services in the
treatment of ESRD has an oral infection,
the success of those dialysis services
could be compromised if the infection is
not properly diagnosed and treated prior
to the covered medical services.
Without an oral or dental examination
to identify such an infection and the
provision of necessary treatment, such
as restorative dental services, to
eradicate the infection prior to the
dialysis procedure, the patient’s ability
to complete the dialysis services could
be seriously complicated or
compromised and the risk of infection
would further increase the risk of
mortality for the patient.
Examples of restorative dental
services to eradicate infection could
include: extractions (removal of the
entire infection, such as pulling of
teeth—for example, CDT D7140, D7210),
restorations (removal of the infection
from tooth/actual structure, such as
fillings—for example, CDT D2000–
2999), periodontal therapy (removal of
the infection that is surrounding the
tooth, such as scaling and root
planning—for example, CDT D4000–
4999, more specifically D4341, D4342,
D4335 and D4910), or endodontic
therapy (removal of infection from the
inside of the tooth and surrounding
structures, such as root canal—for
example, CDT D3000–3999).
If such an infection is not treated
prior to dialysis services in the
treatment of ESRD, then there is an
increased likelihood for morbidity and
mortality resulting from spreading of the
local infection to BSI and sepsis.
Likewise, we believe that infections
occurring during the course of dialysis
treatment should similarly be addressed
and resolved in order to minimize the
risk of infection and death for the
patient with ESRD receiving dialysis
services.
Because an oral or dental infection
can present substantial risk to the
success of dialysis treatment for ESRD,
we believe dental services furnished to
identify, diagnose, and treat oral or
dental infections prior to or
contemporaneously with dialysis
services in the treatment of ESRD are
not in connection with the care,
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treatment, filling, removal, or
replacement of teeth or structures
directly supporting teeth, but instead
are inextricably linked to, and
substantially related and integral to the
clinical success of, these other covered
medical services. We note that, in these
circumstances, the necessary treatment
to eradicate an infection may not be the
totality of recommended dental services
for a given patient. For example, if an
infected tooth is identified in a patient
requiring dialysis services in the
treatment of ESRD, the necessary
treatment would be to eradicate the
infection, which could result in the
tooth being extracted. Additional dental
services, such as a dental implant or
crown, may not be considered
immediately necessary to eliminate or
eradicate the infection or its source
prior to surgery. Therefore, such
additional services would not be
inextricably linked to, and substantially
related and integral to the clinical
success of, Medicare-covered dialysis
services when used in the treatment of
ESRD. As such, no Medicare payment
would be made for the additional
services that are not immediately
necessary prior to or
contemporaneously with dialysis for
ESRD to eliminate or eradicate the
infection.
In conclusion, 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 at
paragraph A to include dental or oral
examination performed as part of a
comprehensive workup in either the
inpatient or outpatient setting prior to
Medicare-covered dialysis services
when used in the treatment of ESRD;
and medically necessary diagnostic and
treatment services to eliminate an oral
or dental infection prior to, or
contemporaneously with Medicarecovered dialysis services when used in
the treatment of ESRD. We seek
comments on all aspects of this
proposal.
3. Request for Comment on Dental
Services Integral To Specific Covered
Services to Treat Diabetes
As described in section II.J.1.c. of this
proposed rule, we have received
information from interested parties,
including submitters providing
evidence through the public
submissions process as well as
commenters on prior proposed rules
suggesting that dental services are
inextricably linked to treatment services
for individuals with diabetes mellitus.
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Several interested parties using the
public submissions process have urged
us to provide Medicare payment for
dental services for individuals
diagnosed with diabetes for
consideration in CY 2025 rule making.
These submissions included
information and references supporting
oral and dental treatment of advanced
periodontitis among individuals with
diabetes to improve markers related to
management of the diabetes.
Submitters stated that clinical studies
demonstrate that dental treatments for
oral infections, such as advanced
periodontitis and related inflammation,
meaningfully advance and improve the
treatment of, management of, and
outcomes for patients with diabetes.
Submitters also stated that conversely,
the absence of treatment of chronic
dental infections in turn complicates
covered medical treatment for the
management of diabetes and potentially
exacerbates insulin resistance, worsens
glycemic control, and other diabetesrelated complications, leading to poor
outcomes for the individuals with
diabetes. Submitters also noted that
studies demonstrate cost savings when
dental services are employed in the
treatment of individuals with diabetes
and also serve to advance health equity
among vulnerable populations.
Submitters provided information
detailing the increased risk of dental
caries and periodontal disease in people
with diabetes, many of whom lose teeth,
which greatly limits nutrition, general
well-being, and overall quality of life.
Submitted studies demonstrated the
bidirectional nature of periodontal
disease and diabetes, suggesting that
both conditions influence each other
and can worsen or conversely improve
outcomes.
As described by submitters, numerous
basic and clinical studies describe the
relationship between oral diseases and
inflammation in persons with diabetes,
which increases risks for micro- and
macrovascular complications including
retinopathy, nephropathy, neuropathy,
cardiovascular diseases, and stroke.
Several submitters stated that there is a
documented reduction in
hospitalizations in persons with
diabetes who receive conservative
periodontal treatment. Consequently,
submitters stated that periodontal
treatment is recommended for patients
with diabetes by American Diabetes
Association Clinical Guidelines and is
also promoted by the American
Association of Clinical Endocrinologists
and others.212
212 Nuha A. El Sayed, Grazia Aleppo, Vanita R.
Aroda, Raveendhara R. Bannuru, Florence M.
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Diabetes mellitus is a chronic,
metabolic disease characterized by
elevated levels of blood glucose (or
blood sugar), which, over time, may
lead to serious damage to the heart,
blood vessels, eyes, kidneys, and nerves.
Type 2 diabetes, which usually occurs
in adults, causes the body to become
resistant to insulin or not to make
enough insulin. Type 1 diabetes,
previously referred to as juvenile
diabetes or insulin-dependent diabetes,
is a chronic condition in which the
pancreas produces little or no
insulin.213
A primary goal for the treatment of
diabetes is glycemic control and
requires accurate individualization and
customization of available treatment
options. Interventions to address
lipoproteins, blood pressure, weight
control, mental health, and lifestyle are
important factors that contribute to
quality of life and the frequency of
diabetes-associated complications.214
According to recent statistics from the
Centers for Disease Control and
Prevention, approximately 38 million
people in the United States may have
diabetes, and the CDC estimates that 1
in 5 of them do not know they have the
condition. Approximately 98 million
U.S. adults likely have prediabetes, and
more than 8 in 10 of them may not
know they have prediabetes. Notably,
diabetes is the eighth leading cause of
death in the United States (and may be
underreported). Type 2 diabetes
accounts for approximately 90 to 95
percent of all diagnosed cases of
diabetes, while Type 1 diabetes
accounts for approximately 5–10
percent. The CDC reports that over the
last 20 years, the number of adults
diagnosed with diabetes has more than
doubled as the American population has
aged and become more overweight or
obese.215
One key marker for the measurement
of glycemic control, a key goal in the
Brown, Dennis Bruemmer, Billy S. Collins, Kenneth
Cusi, Sandeep R. Das, Christopher H. Gibbons, John
M. Giurini, Marisa E. Hilliard, Diana Isaacs, Eric L.
Johnson, Scott Kahan, Kamlesh Khunti, Mikhail
Kosiborod, Jose Leon, Sarah K. Lyons, Lisa
Murdock, Mary Lou Perry, Priya Prahalad, Richard
E. Pratley, Jane Jeffrie Seley, Robert C. Stanton,
Jennifer K. Sun, Crystal C. Woodward, Deborah
Young-Hyman, Robert A. Gabbay; on behalf of the
American Diabetes Association, Summary of
Revisions: Standards of Care in Diabetes—2023.
Diabetes Care 1 January 2023; 46 (Supplement_1):
S5–S9. https://doi.org/10.2337/dc23-Srev.
213 https://www.who.int/health-topics/diabetes.
214 Melmer A, Laimer M. Treatment Goals in
Diabetes. Endocr Dev. 2016;31:1–27. doi: 10.1159/
000439364. Epub 2016 Jan 19. PMID:
26824869.https://pubmed.ncbi.nlm.nih.gov/
26824869/.
215 https://www.cdc.gov/diabetes/basics/quickfacts.html.
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treatment of diabetes, in individuals
with diabetes is the hemoglobin A1c
test. The hemoglobin A1c (also referred
to as glycated hemoglobin, glycosylated
hemoglobin, HbA1c, or A1c) test is used
to evaluate a person’s level of glucose
control and shows an average of the
blood sugar level over the past 90 days
and represents a percentage.216
Submitters through the public
submissions process provided multiple
research studies regarding the
interaction between dental services and
outcomes for medical services to treat
diabetes. The Cochrane Library (ISSN
1465–1858) is a collection of databases
that contain high-quality, independent
evidence to inform healthcare decisionmaking. The Cochrane Library is owned
by Cochrane and published by Wiley.217
In the Cochrane Review entitled
Treatment of periodontitis for glycaemic
control in people with diabetes mellitus,
evidence from 30 trials (results from
2,443 participants) showed that
periodontitis treatment reduces blood
sugar levels (measured by HbA1c) in
diabetic patients on average by 0.43
percentage points (for example, from
7.43 to 7 percent; 4.7 mmol/mol) 3 to 4
months after receiving the treatment
compared with no active treatment or
usual care. A difference of 0.30 percent
(3.3 mmol/mol) was seen after 6 months
(12 studies), and 0.50 percent (5.4
mmol/mol) at 12 months (one study).218
All studies in the review used a parallel
randomized controlled trials (RCT)
design and followed participants for
between 3 and 12 months. The studies
generally focused on people with type 2
diabetes, save one study that included
participants with type 1 or type 2
diabetes. Most studies were mixed in
terms of whether metabolic control of
participants at baseline was good, fair,
or poor and were carried out in
secondary care. Researchers compared
periodontitis treatment with control,
which could be no (or delayed)
treatment or usual care (oral hygiene
instruction (OHI) or supragingival
scaling with or without OHI). The
degree and nature of advanced
periodontitis were not specifically
defined in the context of the studies.
Additionally, the studies did not control
for other types of interventions
deployed in the treatment of diabetes
(that is, strategies used to manage
216 https://www.ncbi.nlm.nih.gov/books/
NBK549816/.
217 https://www.cochranelibrary.com/about/
about-cochrane-library.
218 Simpson TC, et al. Treatment of periodontitis
for glycaemic control in people with diabetes
mellitus. Cochrane Database Syst Rev.
2022;4:CD004714 https://www.ncbi.nlm.nih.gov/
pubmed/35420698.
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glycemic control), so patients may have
been receiving other types of treatment
during the study periods.
The types of periodontal treatment
provided covered a wide range of oral
services: subgingival instrumentation,
surgical periodontitis treatment–flap
surgery or gingivectomy; antimicrobial
therapy (encompassing antibacterials
and antibiotics), either locally applied
(including mouth rinses, gels, or
dentifrices) or systemically
administered; other drug therapy with a
possible benefit of improving the
periodontal condition of the participant;
other novel interventions to manage
periodontitis; supragingival scaling (also
known as professional mechanical
plaque removal (PMPR)); oral hygiene
instruction; and/or, education or
support sessions to improve self-help or
self-awareness of oral hygiene.
In summary, the Cochrane review
demonstrated that individuals with
diabetes who have periodontitis who
receive dental services for the treatment
of the periodontitis experience a
statistically significant reduction of
HbA1c. Again, measurement of HbA1c
is a metric for gauging glycemic control
and is a primary goal of treatment for all
individuals with diabetes. The study
suggests that individuals with diabetes
who also have a diagnosis of
periodontitis who receive treatment to
address the periodontitis subsequently
experience a reduction in HbA1c. The
study authors described the clinical
outcomes related to preventive dental
care, conservative periodontal
treatment, and reduction in HbA1c as
statistically and clinically significant.
Moreover, the authors of the research
stated that ‘‘further trials evaluating no
treatment vs usual care are unlikely to
change this conclusion.’’ 219
Submitters providing information
through the public submissions process
suggested that dental services could be
inextricably linked to the following
specific medical services in the
treatment of diabetes:
• CPT 36901–36906: Dialysis circuit
procedures.
• CPT 82947: Chemistry procedures,
blood glucose testing.
• CPT 83036: Hemoglobin A1C
testing.
• CPT 90935, 90937, 90940:
Hemodialysis procedures.
• CPT 90961: Physician or other
qualified healthcare professional visits
for ESRD.
219 Simpson TC, et al. Treatment of periodontitis
for glycaemic control in people with diabetes
mellitus. Cochrane Database Syst Rev.
2022;4:CD004714 https://www.ncbi.nlm.nih.gov/
pubmed/35420698.
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• CPT 90989–90999: Other dialysis
procedures.
• CPT 92227–92229: Diabetic
retinopathy screening.
• CPT 99091: Collection and
interpretation of physiologic data.
• CPT 99202–99215: Evaluation and
Management (E/M) Services.
• CPT 99211: Office visit for an
established patient.
• CPT 99487: Complex chronic care
management services.
• CPT 99490–99491: Chronic care
management services.
• CPT 99497: Remote physiologic
monitoring services.
• CPT 99605–99607: Medication
Management.
• CPT 99802–99804: Assessment,
Intervention, Face to Face (F2F).
• DRG 637: Hospitalization for
diabetes with major complications.
• G0108: Diabetes Self-Management
Training.
• G0109: Group Diabetes SelfManagement Training.
• G0270: Nutrition Therapy.
• G0466: FQHC visit new patient.
• G0467: FQHC visit established
patient.
As described in this section, research
provided by submitters suggests that
periodontal treatment for an individual
with both a diagnosis of diabetes and
periodontitis led to improved HbA1c
measures.
We have explained that there are
instances where dental services are so
integral to other medically necessary
services that they are inextricably linked
to the clinical success of that medical
service(s), and, as such, they are not in
connection with the care, treatment,
filling, removal, or replacement of teeth
or structures directly supporting teeth
within the meaning of section
1862(a)(12) of the Act. Rather, these
dental services are inextricably linked to
the clinical success of an otherwise
covered medical service and are payable
under Medicare Parts A and B.
In the case of an individual with
diabetes who also has a diagnosis of
periodontitis, oral services and
treatment to address the periodontitis
potentially lead to a reduction in
HbA1c, a marker of glycemic control
that may be used to determine the
effectiveness of interventions for
treatment of diabetes. In the description
of the studies submitted, the research
seems to indicate that the improvement
of glycemic control as evidenced by the
HbA1c is due to the provision of
treatment for the periodontitis. The
dental and oral services may not be
integral to other specific medically
necessary, covered services, but rather
the dental and oral services may serve
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to influence clinical outcomes directly.
The studies compare the impact of the
treatment for the periodontitis to the
impact of pharmacological
interventions.
We recognize that evidence submitted
by interested parties demonstrates that
an individual with both a diagnosis of
diabetes and a diagnosis of periodontitis
who in turn receives periodontal
treatment services may experience
improvements in markers for HbA1c,
which is a key target outcome for the
patient population with diabetes.
However, the interaction between these
diagnoses and the potential
improvements due to periodontal
treatment services does not appear to
align with the framework we have
established to pay for dental services
inextricably linked to covered services;
in our framework, the delivery of certain
dental services are integral to the
successful completion of or outcomes
related to the covered services.
Under § 411.15(i)(3), we have
specified that payment can be made for
certain dental services that are
inextricably linked to other services
when the specific covered services with
which the dental services are
inextricably linked are identified. The
studies that have been provided to CMS
through submissions have not identified
any specific covered services for the
treatment of diabetes to which dental
services are inextricably linked. Rather,
the studies indicate that the primary
treatment of periodontal disease in
patients with diabetes generally leads to
better outcomes in the management of
the patients’ diabetes. While the
research makes the case that the dental
services are medically necessary for
patients with diabetes, medical
necessity alone does not permit
payment for dental services given the
broad statutory prohibition under
section 1862(a)(12) on payment for
services ‘‘in connection with the care,
treatment, filling, removal, or
replacement of teeth or structures
directly supporting teeth.’’ In the case of
patients with diabetes, the research does
not appear to show that certain dental
services are inextricably linked with
certain other covered services for the
treatment of diabetes, in accordance
with our regulation at § 411.15(i)(3)
such that the statutory prohibition
under section 1862(a)(12) does not
apply.
We note that some of the examples of
medical services for diabetes treatment
provided by submitters are general in
nature and not specific to patients with
diabetes who may also have periodontal
disease, including CPT codes 99202–
99215: Evaluation and Management (E/
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M) Services that broadly describe
outpatient office visits for the diagnosis
and medical management of practically
any illness, disease, or condition.
Additionally, submitters providing
evidence for our consideration
suggested that the services described by
codes for diabetes self-management
training (for example, G0108: Diabetes
Self-Management Training, and G0109:
Group Diabetes Self-Management
Training) are services with which dental
services may be inextricably linked.
However, we were not persuaded by
this evidence and do not believe that
dental services would be inextricably
linked to improved outcomes for
services for DSMT. Therefore, we seek
comment from the public regarding
specific covered services for
management of patients with diabetes
with which dental services may be
inextricably linked. At this time, we are
not proposing to amend § 411.15(i)(3)(i)
as we have not identified additional
dental services that are inextricably
linked to certain services in the
treatment of diabetes. However, we note
that we remain open to considering any
such services identified by public
commenters, and, if sufficient evidence
is presented, we may consider adding
such services to our regulations in the
final rule.
In the context of payment for dental
services for an individual with diabetes,
we seek information from the public
regarding what the coordination
between a medical and dental
professional would entail in the
scenario where an individual with a
diagnosis of diabetes presents with
suspected periodontitis. In the CY 2023
PFS final rule, we explained that we
would make payment when a doctor of
dental medicine or dental surgery
(referred to as a dentist) furnishes dental
services that are an integral part of the
covered primary procedure or service
furnished by another physician, or nonphysician practitioner, treating the
primary medical illness. However, if
there is no exchange of information, or
integration, between the medical
professional (physician or other nonphysician practitioner) in regard to the
primary medical service and the dentist
in regard to the dental services, then
there would not be an inextricable link
between the dental and covered medical
service within the meaning of our
regulation at § 411.15(i)(3). Without
both integration between the Medicare
enrolled medical and dental
professional, and the inextricable link
between the dental and covered
services, Medicare payment for dental
services would be prohibited under
section 1862(a)(12) because the services
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are in connection with the care,
treatment, filling, removal, or
replacement of teeth or structures
directly supporting teeth; though they
may be covered by types of
supplemental health or dental coverage
(87 FR 69687 through 69688).
In a situation where a medical
professional believes that an individual
with a diagnosis of diabetes may also
have a diagnosis of periodontitis, how
are recommendations conveyed between
the medical and dental professionals?
What coordination, if any, occurs
between the medical and dental
professionals? We expect that
inextricably linked services related to
the treatment of periodontitis in an
individual with diabetes would require
significant communication between the
medical and dental professionals.
Additionally, we have stated that an
inextricable linkage may exist between
dental services and covered services
when the standard of care for the
medical service is such that the
practitioner would not proceed with the
medical procedure or service without
performing the dental services, because
the covered medical services would or
could be significantly and materially
compromised, or where dental services
are a clinical prerequisite to proceeding
with the primary medical procedure
and/or treatment (87 FR 69669). While
evidence supports that individuals with
diabetes and periodontitis who receive
periodontal treatment experience
improvements in their HbA1c markers,
dental services do not appear to serve as
a precondition to overall treatment for
the diabetes. We seek information from
the public on how oral treatment
services may be a clinical prerequisite
in the treatment protocol for the care of
individuals with diabetes.
We note that there does not appear to
be a clear or singular definitional
framework for categorizing the state of
diabetes, such as ‘‘controlled’’ or
‘‘uncontrolled’’ diabetes. Research
submitted by the public discusses
improvements in glycemic control as
evidence by HbA1c markers, but does
not delineate the characteristics of a
patient that would require direct
clinical intervention (pharmacological,
behavioral, usage of DME such as
insulin pumps, etc.) versus a patient
that would not require interventions
given that their disease state is not
within a concerning range requiring
direct medical treatment.
In the current literature, there are two
types of severity measures that can help
categorizing the state of diabetes: the
severity of diabetes itself and the
severity of periodontal disease among
individuals with diabetes. With respect
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to the severity of diabetes, the American
Diabetes Association recommends that
most adults with diabetes aim for a
HbA1c level below 7.0% (<53 mmol/
mol), along with other recommended
targets such as blood pressure below
130/80 mmHg and LDL cholesterol
below 100 mg/dL.220 In the current
literature, uncontrolled hyperglycemia
is typically defined as a HbA1c level
above 8.0% (>64 mmol/mol), according
to guidelines from various medical
organizations including the ADA,
American College of Physicians,
Association of Clinical
Endocrinologists, and American College
of Endocrinology.221 222 223 224 Based on
the literature, this threshold serves as a
‘‘take action’’ point in managing
diabetes and has been used in previous
studies to indicate poor glycemic
control. Achieving and maintaining
target HbA1c levels is essential for
individuals with diabetes (as well as the
general population) and is a key goal of
treatment. Moreover, we note that for
the purposes of Quality Payment
Program (QPP) measures, CMS has
issued measures for diabetes (e.g.
Quality ID #1 (NQF 0059): Diabetes:
Hemoglobin A1c (HbA1c) Poor Control
(>9%)).225 The measure is described as
‘‘Percentage of patients 18–75 years of
age with diabetes who had hemoglobin
A1c > 9.0% during the measurement
period.’’ Furthermore, measures of
HbA1c may fluctuate over time;
therefore, a strict threshold could lead
to incentives for multiple rounds of
testing in order to aim for the levels
established. In general, guidelines exist,
but standards vary for defining diabetes
220 American Diabetes Association. ‘‘Standards of
medical care in diabetes—2011.’’ Diabetes care vol.
34 Suppl 1, Suppl 1 (2011): S11–61. doi:10.2337/
dc11–S011.
221 Liu, Longjian et al. ‘‘Burden of Uncontrolled
Hyperglycemia and Its Association with Patients
Characteristics and Socioeconomic Status in
Philadelphia, USA.’’ Health equity vol. 4,1 525–
532. 30 Dec. 2020, doi:10.1089/heq.2020.0076.
222 Qaseem, Amir et al. ‘‘Glycemic control and
type 2 diabetes mellitus: the optimal hemoglobin
A1c targets. A guidance statement from the
American College of Physicians.’’ Annals of internal
medicine vol. 147,6 (2007): 417–22. doi:10.7326/
0003–4819–147–6–200709180–00012.
223 Cortez-Espinosa, Nancy et al. ‘‘Abnormal
expression and function of Dectin-1 receptor in type
2 diabetes mellitus patients with poor glycemic
control (HbA1c>8%).’’ Metabolism: clinical and
experimental vol. 61,11 (2012): 1538–46.
doi:10.1016/j.metabol.2012.03.020.
224 Hu, Huanhuan et al. ‘‘Hba1c, Blood Pressure,
and Lipid Control in People with Diabetes: Japan
Epidemiology Collaboration on Occupational
Health Study.’’ PloS one vol. 11,7 e0159071. 20 Jul.
2016, doi:10.1371/journal.pone.0159071.
225 https://qpp.cms.gov/docs/QPP_quality_
measure_specifications/CQM-Measures/2023_
Measure_001_MIPSCQM.pdf.
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states based on multiple severity
measures.
In addition, the severity of
periodontal disease is not uniformly
defined. ICD–10 codes, such as K05.2
for Aggressive Periodontitis and K05.3
for Chronic Periodontitis may be
utilized to describe more severe
instances of periodontitis (and in this
instance when such diagnosis codes are
also partnered with diagnoses related to
diabetes for a particular individual).
Another approach involves using the
Armitage criteria for periodontal
diagnosis.226 227 Severity assessment can
be based on the clinical attachment
level (CAL), with CAL between 1 mm
and 2 mm classified as slight, 3 mm and
4 mm as moderate, and ≥5 mm as
severe.228 Again, some standards exist
relative to the staging of periodontitis,
but such criteria vary. Additionally, we
believe that the current practice of
medicine would allow for variation in
clinical attributes as well as judgment
and discernment by the referring
practitioner regarding the clinical status
of the individual when determining the
need for consultation with other
practitioner types, including the dentist.
We seek comment on whether clinical
standards exist that describe and define
the disease state of diabetes that would
serve to inform the selection of
treatment modalities, including
potential referrals to dental
professionals with respect to concerns
related to oral health. We also seek
comment from the public regarding the
ways that CMS could ensure that
practitioners do not decrease the quality
of diabetes treatment in an effort to
maintain a beneficiary’s potential access
to Medicare payment for dental services.
Evidence supplied by submitters also
described periodontitis but without
clear and consistent definitional
structure. The 2017 World Workshop on
the Classification of Periodontal and
Peri-Implant Diseases and Conditions
resulted in a new classification of
periodontitis characterized by a
multidimensional staging and grading
system. The staging considers the
aspects of severity, complexity, extent,
and distribution while the grading
226 Armitage, G C. ‘‘Development of a
classification system for periodontal diseases and
conditions.’’ Annals of periodontology vol. 4,1
(1999): 1–6. doi:10.1902/annals.1999.4.1.1.
227 Caton, Jack G et al. ‘‘A new classification
scheme for periodontal and peri-implant diseases
and conditions—Introduction and key changes from
the 1999 classification.’’ Journal of clinical
periodontology vol. 45 Suppl 20 (2018): S1–S8.
doi:10.1111/jcpe.12935.
228 Pinho, M Morado et al. ‘‘Periodontitis and
atherosclerosis: an observational study.’’ Journal of
periodontal research vol. 48,4 (2013): 452–7.
doi:10.1111/jre.12026.
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contemplates primary criteria such as
progression and grade modifiers,
including risk factors such as smoking
and diabetes.229
For the purposes of our consideration
of medical services for the treatment of
diabetes for individuals with diabetes
who have periodontitis, we seek
comment from the public on clinical
criteria that would determine eligibility
for effectiveness of periodontal
treatment as described in the Cochrane
review and other studies. We do not
believe that a condition such as
gingivitis or early stages of periodontitis
would require oral treatment that in
turn would influence the outcomes for
an individual with diabetes. However,
we seek information to address the
following questions. At what stages and
grading would the periodontitis be
considered advanced and/or requiring
dental and oral treatment intervention?
What types of practitioners are able to
make determinations regarding the
staging of periodontitis? We also seek
comment on patient eligibility. What
determines patient eligibility for
treatment for advanced periodontitis?
Are there other criteria for
consideration?
Additionally, we seek comment on
the duration of potential periodontal
treatment. How is the length of
treatment determined? If a patient’s
clinical status improves with respect to
the periodontal disease, what factors
determine when periodontal treatment
comes to an end? What does
maintenance treatment entail? What
services are provided in treatment of
advanced periodontal disease? What is
the service definition? Are services
bundled? If yes, what is included in the
bundle? When are the services provided
and over what period? Is it provided
over a calendar month period? A single
day? Multiple days? Are services timed?
Who provides the services? What
specific terminology is involved? Are
these services ever provided under
supervision? Or ‘‘incident to’’ by other
clinical staff?
We also seek information on how
services for advanced periodontal
disease are provided. Where and how
are services for treatment of advanced
periodontal disease provided? Are there
any special rules, such as obtaining
advance consent or performance of an
initiating visit?
We also seek information regarding
coding and billing of periodontal
services. What coding is utilized for the
229 Tables from Tonetti, Greenwell, Kornman. J
Periodontol 2018;89 (Suppl 1): S159–S172. https://
www.perio.org/wp-content/uploads/2019/08/
Staging-and-Grading-Periodontitis.pdf.
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treatment services for advanced
periodontal disease? What claims format
is employed for the submission of
claims with related oral and dental
services (for example, 837D and/or
837P)?
Additionally, we seek comment from
the public regarding the risk of
recurrence of periodontal disease for
this patient population. What is the
level of risk for re-development of
advanced periodontitis and likelihood
of recurrence?
We also seek information regarding
the role of caries in management of
diabetes. What is the prevalence of
caries in this patient population? What
is the impact of caries on management
of diabetes?
We also seek information regarding
the disease state of the diabetes itself
and its interaction with dental services.
Does evidence exist to support that
certain characteristics related to
diabetes management (for example,
maintenance of HbA1c) are more closely
tied to certain oral interventions’ ability
to yield clinical improvements?
We reiterate that 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.
Thus, payment is permitted only where
the dental services are inextricably
linked to covered medical services. We
believe that general maintenance and
management of oral disease processes
clearly falls within the statutory
exclusion and therefore Medicare would
not permit payment for routine dental
and oral services.
We note that many submitters stated
that good dental and oral health benefits
a patient’s overall health in general.
Several commenters responding to 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
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section 1862(a)(12) of the Act (88 FR
79033).
In summary, we seek comment on
whether certain dental services are
inextricably linked to certain other
covered services for diabetes, supported
by clinical evidence as described in
section II.J.1.c. of this proposed rule. We
also seek comment specifically on
whether dental services such as
prophylaxis are a standard of care in the
management of diabetes. We are
committed to continuing to explore the
potential inextricable relationship
between dental services and covered
medical services utilized in treatment
for individuals with diabetes. We thank
submitters for the information they
provided through the public
submissions process and may consider
revisions to the clinical examples
codified in our regulations at
§ 411.15(i)(3)(i) based upon additional
data and information received in
response to this proposed rule.
4. Request for Comment on Dental
Services Integral To Specific Covered
Services To Treat Systemic
Autoimmune Disease Requiring
Immunosuppressive Therapies
We have received information from
submitters suggesting that certain dental
services are inextricably linked to
immunosuppressive therapies for
individuals with autoimmune disorders.
According to the NIH’s National
Institute of Environmental Health
Sciences, a healthy immune system is
able to defend the body against disease
and infection. However, if the immune
system malfunctions, it may mistakenly
attack healthy cells, tissues, and organs.
This scenario is called autoimmune
disease, and these attacks can affect any
part of the body, weaken bodily
function, and in some cases become lifethreatening.230 There are over 100
autoimmune diseases, including Type 1
diabetes, multiple sclerosis, lupus,
rheumatoid arthritis, and inflammatory
bowel disease. There are also other
autoimmune diseases that are rare and
difficult to diagnose. In some cases,
patients may suffer for years before
receiving a proper diagnosis, and most
of these diseases have no cure.
Additionally, some autoimmune
diseases require lifelong treatment for
system management.231
Autoimmune diseases are
continuously affecting more people.
Estimates indicate that as many as 50
million people in the U.S. have an
autoimmune disease, making it the third
230 https://www.niehs.nih.gov/health/topics/
conditions/autoimmune.
231 Ibid.
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most prevalent disease category,
surpassed only by cancer and cardiac
disease. Generally speaking, a person’s
genes in combination with infections
and other environmental exposures
likely play a significant role in disease
development, though in some instances
pathology may be unknown.
Additionally, nearly 80 percent of
people with a chronic autoimmune
condition are women.232 Symptoms of
autoimmune diseases can include:
fatigue, pain, dermatologic
manifestations, weight loss or gain,
insomnia, fever, and myriad other
symptoms.233
Many treatment modalities are
employed in the management of
autoimmune diseases. Treatments could
include use of oral medications,
including steroids, anti-inflammatory
medications, as well as infusion
immunotherapy. Some autoimmune
conditions may present in a localized
fashion, such as Sjogren’s, and many of
the independent organ inflammations,
require immunosuppressive therapies,
and may progress to a more systemic
involvement. Conversely, some systemic
autoimmune diseases, like sarcoidosis,
may not require immunosuppression in
mild cases.
Submissions through the public
submissions process urged us to provide
that payment can be made for dental
services for individuals with
autoimmune diseases receiving
immunosuppressive therapy. In
submissions, several interested parties
have asserted that immunosuppressive
therapies utilized in the treatment of
autoimmune disease have similar
immunosuppressive effects as those of
toxic chemotherapy utilized in the
treatment of cancer and that these
treatments are analogous to the clinical
examples finalized in CY 2024 PFS
rulemaking for dental services
inextricably linked to covered medical
services in the treatment of cancer.
Submitters stated that oral and dental
treatment is also often integral to the
successful care and management of
beneficiaries with autoimmune diseases
who are initiating or undergoing
immunosuppressive or
immunomodulator therapy because the
absence of medically necessary oral and
dental treatment can pose serious
complications to those beneficiaries and
the covered medical services they
receive. Submitters state that, for
example, dental infections can spread
quickly when host immunity is
compromised by immunosuppressing or
232 Ibid.
233 https://www.womenshealth.gov/a-z-topics/
autoimmune-diseases.
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immunomodulating drugs utilized in
treatment. As such, submitters note that
the American College of Physicians has
described that the implications of dental
disease in patients who are undergoing
immunosuppressive therapy extend
beyond their oral disease, with
potentially life-threatening
complications if the dental problems are
not treated. For these reasons,
submitters state that the covered
services upon which
immunocompromised patients depend
(for example, immunosuppressive
therapy) should not proceed until a
dental or oral exam is performed to
address the oral complications and/or
clear the patient of an oral or dental
infection.
Submitters provided information
regarding specific covered services that
they believe could be associated with
treatments for immunosuppressive
therapy for the treatment of
autoimmune disease and that may
increase infection risk, such as:
• CPT codes 99212–99215:
Evaluation and Management (E/M)
Services.
• CPT codes 96365–96368: Infusion
services.
Submitters also provided coding
information related to drug therapies,
such as CPT codes for
immunosuppressant drugs, including:
• J0129: Abatacept (Orencia) for
Rheumatoid Arthritis.
• J0135: Adalimumad (Humira) for
Crohn’s, Ulcerative Colitis, Rheumatoid
Arthritis.
• J0490: Belimumab (Benlysta) for
systemic lupus erythematosus (SLE),
Lupus Nephritis, and Sjögren’s.
• J0491: Anifrolumab-fnia (Saphnelo)
for systemic lupus erythematosus (SLE).
• J1303: Ravulizumab-cwvz
(Ultomiris) for Generalized Myasthenia
Gravis.
• J1438: Etanercept (Enbrel) for
Rheumatoid Arthritis, Ankylosing
Spondylitis.
• J1595: Glatiramer (Copaxone) for
Multiple Sclerosis.
• J1602: Golimumab (Simponi) for
Rheumatoid Arthritis, UC, Ankylosing
Spondylitis.
• J1745: Infliximab (Remicade) for
Crohn’s, Ulcerative Colitis, Rheumatoid
Arthritis.
• J2250: Upadacitinib (Rinvoq) for
Rheumatoid Arthritis, Ulcerative Colitis,
Crohn’s.
• J2323: Natalizumab (Tysabri) for
Multiple Sclerosis.
• J2350: Ocrelizumab (Ocrevus) for
Multiple Sclerosis.
• J3262: Tocilizumab (Actemra) for
Scleroderma-associated lung fibrosis.
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• J3357: Ustekinumab (Stelara) for
Crohn’s, Ulcerative Colitis, Psoriatic
Arthritis.
• J3380: Vedolizumab (Entyvio) for
Crohn’s, Ulcerative Colitis.
• J3590: Secukinumab (Cosentyx) for
Plaque Psoriasis.
• J7500: Azathioprine (Imuran) for
Lupus, Crohn’s, Sjögren’s.
• J7517: Mycophenolate (Cellcept) for
Lupus, Sjögren’s.
• J9070: Cyclophosphamide
(Cytoxan) for Sjögren’s, Vasculitis.
• J9250: Methotrexate for Sjögren’s,
Rheumatoid Arthritis (unresponsive to
other treatment).
• J9302: Ofatumumab (Kesimpta) for
Multiple Sclerosis.
• J9312: Rituximab (Rituxan) for
Rheumatoid Arthritis, Sjögren’s.
• J9332: Efgartigimod (Vyvgart) for
Myasthenia Gravis.
Submitters also provided coding
information for potential medical
services for medical treatment for
pulmonary diseases when aspiration of
dental pathogens risk or cause the
initiation and/or recurrence of
complications, such as:
• CPT codes 99212–99215:
Evaluation and Management (E/M)
Services.
• CPT code 99291: Critical Care
Services.
• DRG code 177: Hospitalization for
respiratory infections and inflammation.
• DRG code 190: COPD with
complications.
Submitters also provided coding
regarding medical treatment for dentally
sourced dissecting maxillofacial space
infections:
• CPT 41000: Intraoral incision and
drainage of abscess.
• CPT 87181: Antibiotic
susceptibility study.
• CPT 96365: Infusion of antibiotic.
• CPT codes 99281–99285:
Emergency department services.
• CPT codes 99291–99292: Critical
care services.
• DRG code 135: Sinus procedures
with CC/MCC.
• DRG code 141: Major head and neck
procedures with CC.
• DRG code 872: Hospitalization for
septicemia or severe sepsis.
Submitters providing information
through the public submissions process
stated that if dental or oral infections are
left undetected or untreated in the
population of individuals undergoing
immunosuppressive therapy for
autoimmune disease, serious
complications may occur and negatively
impact the course and outcome of the
covered medical procedures, which
submitters state is analogous to
previously finalized policies for dental
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services inextricably linked to covered
cancer treatment for the patient. Several
submitters pointed out that we stated in
the CY 2024 PFS final rule that
proceeding without a dental or oral
exam of the mouth prior to
chemotherapy could lead to systemic
infection or sepsis, among other
complications, and that similar
outcomes can follow for those receiving
immunosuppressive therapy to treat
autoimmune diseases.
The submitters noted that in the CY
2024 PFS final rule, we described that
AHRQ identified 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 like
oral mucositis and encouraged CMS to
explore this connection to confirm that
dental evaluations and treatment prior
to immunosuppressive therapy would
lead to decreased incidence of serious
oral infections in a similar fashion. The
submitters also stated that they believe
it is critical that beneficiaries with an
autoimmune disease that requires
immunosuppressive therapy have
access to necessary dental services, as
proper dental care for this population
can reduce the incidence of serious
infection and improve overall patient
outcomes for the covered service.
We appreciate the evidence and
information provided by submitters and
agree that we should continue to
research whether there is a connection
between dental and oral evaluations and
treatment prior to immunosuppressive
therapy and outcomes for said therapies,
including the potential decreased
incidence of serious oral infections.
However, we seek comment on
whether the level of
immunosuppression utilized in the
treatment of autoimmune diseases is
analogous to the immunosuppression
levels employed in the treatment of
cancer. We believe that the level of
immunosuppression for systemic
autoimmune disease has different
characteristics versus therapies utilized
in chemotherapy used in the treatment
of cancer. For example, the usage of
monoclonal antibodies in the treatment
of autoimmune disease may not render
the same level of immunosuppression
and subsequent susceptibility to
infection as chemotherapy used in the
treatment of cancer.
We also seek information on the
connection between
immunosuppressive therapy in the
treatment of autoimmune disease and
the likelihood of systemic infection and
sepsis. Specifically, we seek information
regarding the likelihood of dental and
oral sources as the locus of the seeding
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of infection in this patient population.
Additionally, we seek information
regarding standards of care or clinical
guidelines that recommend that a dental
infection be addressed before
proceeding with the
immunosuppressive treatment or the
administration of drugs or whether oral
antibiotics would be prescribed to
resolve the infection and that the
therapy would advance without direct
dental or oral services to address the
infection.
We also seek information regarding
whether there is differential impact
between drugs that are administered in
an office setting or similar versus those
medications that are taken in an oral
fashion.
We thank submitters for the
information they provided through the
public submissions process. We believe
that additional information is necessary
to consider whether there is an
inextricable link between dental
services and covered services to treat
systemic autoimmune disease requiring
immunosuppressive therapies and seek
comment from the public. We remain
open to considering any such services
identified by public commenters, and, if
sufficient evidence is presented, we may
consider adding such services to
§ 411.15(i)(3) in the final rule.
5. Implementation of Payment for
Dental Services Inextricably Linked to
Other Specific Covered Services
In the CY 2024 PFS final rule (88 FR
79035 through 79039), we solicited
comments on whether we should
provide additional guidance that would
aid in processing claims for dental
services that are inextricably linked to a
Medicare-covered medical service.
Some commenters suggested the usage
of a modifier on the dental claim format
that would better identify when dental
services are inextricably linked to
specific covered medical services. As
we continue to consider improvements
to our payment policies and have gained
experience around the provision of
dental services inextricably linked to
covered medical services, we have
explored tools and resources that may
help to facilitate the implementation
and coordination of dental services that
are currently covered under Medicare,
including the possible usage of
modifiers and diagnosis codes. The
usage of modifiers on a dental claim
would seek to identify the dental service
as a service the billing practitioner
identifies as inextricably linked to a
specific covered medical service and for
which there was an exchange of
information, or integration, between the
medical and dental professional
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(physician, including a dentist, or other
non-physician practitioner) as specified
in the CY 2023 PFS final rule (87 FR
69663 through 69688). We have
explained that if there is no exchange of
information, or integration, between the
medical professional (physician or other
non-physician practitioner) regarding
the primary medical service and the
practitioner furnishing the dental
services, then there would not be an
inextricable link between the dental and
covered medical service within the
meaning of our regulation at
§ 411.15(i)(3). Furthermore, integration
between medical and dental
professionals can occur when these
professionals coordinate care. This level
of coordination can occur in various
forms such as, but not limited to, a
referral or exchange of information
between the medical professional
(physician or non-physician
practitioner) and the dentist. This
coordination should occur between a
dentist and another medical
professional (physician or other nonphysician practitioner) regardless of
whether both individuals are affiliated
with or employed by the same entity.
Currently, the KX modifier is
submitted on a Medicare Part B claim to
indicate that the service or item is
medically necessary, and that the
healthcare provider has included
appropriate documentation in the
medical record to support or justify the
medical necessity of the service or item.
We believe that usage of the KX
modifier in the context of claims for
dental services inextricably linked to
covered services would be appropriate
and support claims processing and
program integrity efforts.
Based on comments received and
summarized in the CY 2024 PFS final
rule (88 FR 79037), interested parties
requested that we provide more
guidance on how a practitioner
submitting claims for dental services
can attest that the dental and medical
services are inextricably linked, and that
the criteria have been met to support
payment. We believe that the use of the
KX modifier would allow practitioners
to signal that the dental services meet
the criteria to support payment. Also,
use of the KX modifier may improve the
MACs’ ability to ascertain the volume of
claims that are being submitted for
dental services inextricably linked to
covered services.
Therefore we are proposing that,
effective January 1, 2025, the KX
modifier would be required for claims
submission for dental services
inextricably linked to covered medical
services on both the dental claim format
837D and the professional claim format
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837P. We are proposing that
practitioners who bill for dental services
for which they seek payment in
accordance with § 411.15(i)(3) must
include the KX modifier on the 837D or
837P claim to indicate that they believe
that the dental service meets the
established payment criteria; that the
practitioner has included appropriate
documentation in the medical record to
support or justify the medical necessity
of the service or item and that
demonstrates the inextricable linkage to
covered medical services; and that
coordination of care between the
medical and dental practitioners has
occurred. To help with this transition to
potentially requiring use of the KX
modifier for claims submission for
dental services inextricably linked to
covered medical services beginning in
2025, practitioners now have the option
to utilize the KX modifier as proposed,
for services with dates of service in CY
2024. This optional usage in CY 2024
would not be mandatory and would
serve to support both clinician and
MAC claims processing activities. We
intend to provide additional instruction
and education through subregulatory
guidance regarding this voluntary phase
of the usage of the KX modifier on
claims submitted for dental services
inextricably linked to covered medical
services. We seek comment on all
aspects of this proposal.
While the KX modifier indicates that
the services are medically necessary, the
GY modifier (along with three other
HCPCS denial modifiers) serves to
indicate that a service is not covered
because it is outside of the scope of
Medicare coverage authorized by the
statute. We reiterate that denial
modifiers should be used when
physicians, practitioners, or suppliers
want to indicate that the item or service
is statutorily non-covered.
Use of the GY modifier could support
MAC efforts to adjudicate claims and
remove from the claims processing
pipeline those claims that do not require
further processing. We are seeking
comment on whether we should
recommend the usage of the GY
modifier on the 837D or 837P dental
claim format in instances where a
Medicare claim denial is sought for
purposes of submission to third party
payers or when the service does not fit
within a Medicare benefit category and
is statutorily excluded from coverage.
Additionally, in general, the Act and
our regulations mandate the submission
of diagnostic coding (for example, ICD–
10 codes) on Medicare claims. Section
1842(p)(1) of the Act states that ‘‘each
request for payment, or bill submitted,
for an item or service furnished by a
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physician or practitioner specified in
subsection (b)(18)(C) for which payment
may be made under this part shall
include the appropriate diagnosis code
(or codes) as established by the
Secretary for such item or service.’’
Under this section, each bill or request
for payment for physicians’ services
under Medicare Part B must include the
appropriate diagnostic code ‘‘as
established by the Secretary’’ for each
item or service for which the Medicare
beneficiary received treatment. In the
March 4, 1994 final rule entitled
Medicare Program; Diagnosis Codes on
Physician Bills, we codified that each
bill or request for payment for a service
furnished by a physician under
Medicare Part B must include
appropriate diagnostic coding for the
diagnosis or the symptoms of the illness
or injury for which the Medicare
beneficiary received care and revised
our regulations at § 424.32, Basic
requirements for all claims, to state
specifically that a claim for physician
services must include appropriate
diagnostic coding using diagnostic
information (59 FR 10290).
Additionally, in the CY 2023 PFS
final rule, we stated that dentists are
included in the statutory definition of
physician at section 1861(r)(2) of the
Act and would generally be considered
and treated as a physician for purposes
of enrollment, compliance, and other
administrative programs (87 FR 69673).
Therefore, dentists, who are physicians
for the purposes of the Medicare
program, are required to submit
diagnosis codes on claims for physician
services as described in the statute and
regulations. Furthermore, we note that
diagnosis code information is currently
required on the submission of the
professional claim form 837P;
professional claims lacking such
information are returned to the
healthcare provider and are not
processed.
In the CY 2023 PFS final rule (87 FR
69679 through 69680), we
acknowledged the need to address and
clarify certain operational issues related
to Medicare payment for dental services
inextricably linked to covered services
and noted that we were working to
address these issues, including claims
processing questions raised by the
commenters. We stated that we
anticipated resolving many of the
additional operational issues raised by
commenters potentially as soon as CY
2024, including efforts to adopt the
dental claim form (837D). Similarly, in
the CY 2024 PFS final rule (88 FR
79036), we stated that we continue to
work to address issues raised by
commenters, such as questions related
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61763
to claims processing and efforts to
accommodate the dental claim form
within our claims processing systems,
effective 2024. The efforts related to
adopting the dental claim form are
ongoing, and as efforts advance to
address the implementation and
functionality of claims processing
systems for the dental claim form, we
intend to provide appropriate guidance
and education to interested parties.
We anticipate that our systems will be
able to process claims submitted using
the dental claim form 837D (OMB
Control No. 0938–1471) by January 1,
2025. Consistent with the statutory and
regulatory requirements discussed
above, we intend to require a diagnosis
code to be included on claims submitted
for physicians’ services for dental
services inextricably linked to covered
medical services on both the 837P and
837D formats, beginning on January 1,
2025. However, given the complexities
related to the operational launch of and
transition to the 837D dental claims
format, we are also considering further
delaying the requirement to include a
diagnosis code on the 837D form. For
example, interested parties have
indicated that in current dental practice,
claims processing systems may not
require the submission of a diagnosis
code on claims for dental services, and
therefore dental practices may need
time to adjust to this requirement for the
837D form. We believe that it may be
appropriate to delay this requirement
for a limited time to support clinicians
and billing entities as they seek to
change their workflows and transition to
using the 837D form. We seek comment
on our intention to require the inclusion
of a diagnosis code on the 837D form
beginning on January 1, 2025. We are
particularly interested in any
operational challenges that interested
parties may face in attempting to
comply, as well as other considerations
that we should take into account with
regard to the timing of this requirement.
In the CY 2023 PFS final rule, we
stated that we believed that MACs are
appropriately situated to establish
contractor prices for dental services
inextricably linked to covered services
until we have additional pricing data
that could enable national pricing (87
FR 69680). Therefore, dental services
inextricably linked to covered services
are currently contractor priced.
However, we have received feedback
from the MACs regarding pricing
information for dental services
inextricably linked to covered services,
and the MACs have requested
information that would support their
efforts to assign payment amounts for
such dental services. The MACs retain
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broad flexibility with respect to
assigning payment amounts to claims
for dental services inextricably linked to
covered services; however, we seek to
facilitate the sharing of available pricing
information with the MACs for these
purposes. Thus, we seek comment from
the public on potential sources of
payment information for the pricing of
dental services inextricably linked to
covered services. We note, for example,
that publicly available data (such as Fair
Health cost data) are available for
purchase; however, we understand that
this information may not directly inform
payment amounts in a manner useful for
the payment of Medicare claims for
dental services. According to Fair
Health’s website, cost estimate
information is based on claims for
medical and dental services paid for by
private insurance plans, including the
country’s largest insurers.234 We are also
aware of other fee schedules, such as
those used by state governments for
state employees, or discount fee
schedules, such as discount dental
programs (for example, https://
www.dentalbenefitprogram.com/
groupfees.php?id=NEV). We aim to
support the ongoing efforts by the MACs
to price these services and seek any
information from the public that may
serve to support and inform the MAC
development of payment amounts for
dental services inextricably linked to
covered services.
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6. Request for Information: Services
Associated With Furnishing Oral
Appliances Used for the Treatment of
Obstructive Sleep Apnea
Section 1861(s) of the Act defines the
term ‘‘medical and other health
services’’ that may be covered under
Medicare, including physicians’
services under section 1861(s)(1),
services and supplies furnished incident
to a physician’s professional service
under section 1861(s)(2)(A), and durable
medical equipment (DME) under section
1861(s)(6) of the Act.235
In addition to the statutory definition
of DME, § 414.202 of our regulations
defines DME as equipment furnished by
a supplier or a home health agency that
meets the following conditions:
• Can withstand repeated use.
• Effective with respect to items
classified as DME after January 1, 2012,
has an expected life of at least 3 years.
• Is primarily and customarily used
to serve a medical purpose.
234 https://www.fairhealthconsumer.org/
#answer2; Accessed May 22, 2024.
235 https://www.ssa.gov/OP_Home/ssact/title18/
1861.htm.
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• Generally is not useful to an
individual in the absence of an illness
or injury.
• Is appropriate for use in the home.
For items to be considered DME, all
five criteria of the definition must be
met. The CMS policies for determining
whether an item meets the definition of
DME are further outlined in the
Medicare Benefit Policy Manual (CMS
Pub. 100–02), Chapter 15, section 110.1.
With respect to the first and second
criteria, DME items must be able to
withstand repeated use in the home,
potentially by successive patients.
Different types of oral appliances are
fabricated and furnished by licensed
dentists (DDS or DMD) to reposition oral
and pharyngeal tissues in an effort to
create and maintain a patient’s airway
during sleep for treatment of obstructive
sleep apnea. Obstructive sleep apnea is
a medical disorder in which a person
frequently stops breathing during sleep.
It results from an obstruction of the
upper airway during sleep that occurs
because of inadequate motor tone of the
tongue and/or airway dilator muscles. A
treating practitioner may prescribe use
of an oral appliance as the first line of
treatment for obstructive sleep apnea, or
in cases where other treatments, such as
use of a continuous positive airway
pressure (CPAP) device and/or bi-level
positive airway pressure device have
been tried and failed.
The following two HCPCS Level II
codes were established effective January
1, 2006, for these devices:
• E0485 ‘‘Oral device/appliance used
to reduce upper airway collapsibility,
adjustable or non-adjustable,
prefabricated, includes fitting and
adjustment’’.
• E0486 ‘‘Oral device/appliance used
to reduce upper airway collapsibility,
adjustable or non-adjustable, custom
fabricated, includes fitting and
adjustment’’.
A very limited subset of custom
fabricated oral appliances used to treat
obstructive sleep apnea (HCPCS code
E0486) have been covered for Medicare
beneficiaries by the Durable Medical
Equipment Medicare Administrative
Contractors (DME MACs) under the
DME benefit. These devices are
considered durable equipment by the
DME MACs because of the presence of
a fixed mechanical hinge.
An additional HCPCS code was
established effective April 1, 2022, to
describe custom fabricated oral
appliances without a fixed mechanical
hinge:
• K1027 ‘‘Oral device/appliance used
to reduce upper airway collapsibility,
without fixed mechanical hinge, custom
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fabricated, includes fitting and
adjustment’’.
The DME MACs have not covered any
of the prefabricated devices (HCPCS
code E0485) based on a determination
that there is insufficient evidence to
support that these items are effective
therapy for obstructive sleep apnea. The
DME MAC Local Coverage
Determination for the devices is
available at https://www.cms.gov/
medicare-coverage-database/view/
lcd.aspx?lcdId=33611&ver=25.
For several years, manufacturers of
products without fixed mechanical
hinges that dentists use in custom
fabricating oral appliances have raised
concerns regarding why their versions
of the custom fabricated oral appliances
have not been classified as DME. There
have been an increasing number of
requests for HCPCS codes and Medicare
benefit category determinations from
several different manufacturers of these
products. Using the public meeting
consultation process outlined in
regulations at § 414.240, we obtained
public consultation regarding these
various products. National Medicare
benefit category determinations have
not been established for these
appliances because we have not been
able to confirm that any of the custom
fabricated devices can withstand
repeated use. As indicated above,
equipment must be able to withstand
repeated use in order to be classified as
DME, which means they are items that
can normally be rented and used by
successive patients (repeated use).
We are not aware of any oral
appliances used to treat obstructive
sleep apnea, regardless of whether they
include a fixed mechanical hinge, that
are prefabricated, or custom fabricated,
and can withstand repeated use. These
are oral appliances that do not seem to
be the kind of equipment that could
potentially be rented and used by
successive patients. In addition,
national fee schedule amounts have not
been established for the devices with
the mechanical hinge because of
complexities related to pricing of the
professional services of the dentist that
are integral to the fabrication and
furnishing of the device. The DME
MACs have been paying claims for
devices they have been covering as DME
under code E0486 using local fee
schedule amounts. Before making a final
determination regarding whether these
devices could be classified as DME, we
are requesting information that would
help us determine if oral appliances
used to treat obstructive sleep apnea can
withstand repeated use (furnished as
rental equipment for use by successive
patients).
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As described in section II.J.1.a. of this
proposed rule, 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. Oral sleep
apnea appliances and similar appliances
are used in the direct treatment of sleep
apnea. A treating practitioner may
prescribe the use of an oral sleep apnea
appliance as the first line of treatment
for obstructive sleep apnea, a medical
condition, or in instances where other
treatments, such as use of a CPAP
device and/or bi-level positive airway
pressure device have been tried and
failed. Therefore, we believe that these
appliances and related services, while
utilized in the mouth and situated on
the teeth, would not be considered
services in connection with the care,
treatment, filling, removal, or
replacement of teeth or structures
directly supporting the teeth. Rather, we
believe that oral sleep apnea appliances,
when prescribed by a practitioner for
the treatment of a medical condition
such as obstructive sleep apnea, as
medically reasonable and necessary and
therefore may be payable by Medicare.
Further, we believe that payment for
oral sleep apnea appliances would not
fall within the payment policy for
dental services inextricably linked to
covered medical services, as the
appliances are not services for dental
care, but are instead services and
supplies for the purposes of directly
treating a medical condition unrelated
to teeth or structures directly supporting
the teeth (for example, sleep apnea).
The statutory definition of physician
includes a doctor of dental surgery or of
dental medicine in section 1861(r)(2) of
the Act, and, to the extent payment for
dental services is not precluded under
section 1862(a)(12) of the Act, medically
necessary services furnished by a
dentist may be covered and paid as
physicians’ services under section
1861(s)(1) and (2), and section 1848 of
the Act.
We are requesting information
regarding the types of services furnished
by a dentist or other practitioner related
to oral sleep apnea appliances.
Specifically, we are seeking information
regarding details that may inform or
support a future proposal regarding a
code assignment for services related to
oral sleep apnea appliances under the
Medicare physician fee schedule.
We are requesting details and
information regarding the services
related to the furnishment of oral
appliances used to treat obstructive
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sleep apnea, as described in the
questions below:
• Patient eligibility criteria: to whom
is the service related to the furnishing
of oral appliances being provided? How
is the nuisance snorer differentiated
from the medical condition of sleep
apnea? What criteria are used to
determine whether the provision of
these services may be medically
reasonable and necessary?
• Services provided: What is the
service definition for oral sleep apnea
appliances? Is a bundle of services
provided? If yes, what services are
included in the bundle? What does the
process for evaluating, furnishing, and
fitting of oral sleep apnea appliances
involve? What work is involved? Which
elements of the services are essential
(particularly in terms of what work is
essential to the effectiveness of the
device)? What are the costs associated
with providing these services? What are
the payment amounts for these services?
• Timing of services: What is the
service period? Are the services
provided over a period of time? Are
services timed in any way?
• Practitioner type: Who provides
these services? What credentialing is
required? Is supervision required? Who
would be billing for these services?
Would incident to payment policy rules
apply?
• Location of services: Where and
how are services for oral sleep apnea
appliances provided? Are all services
provided in an in-person setting? Does
the patient have to be present for all
elements of this service? Does the
service involve direct contact with the
patient in each instance?
• Considerations for Telehealth: Are
any of these services provided, or
capable of being provided, via
telehealth?
• Site of service: Can services related
to oral sleep apnea appliances be
provided by hospital-based physicians?
• Other considerations: What billing
procedures exist for these oral sleep
apnea appliances? What existing and/or
additional coding may currently
describe these types of services? In
addition to the HCPCS Level II codes
described above (for example, E0485
and E0486), we believe that the CDT
codes D9947 through D9957 may
describe both the fabrication of the
appliance as well as services provided
during and after fabrication.
We will review any information
provided by the public and consider
potential refinements to PFS payment
policy accordingly. We reiterate that we
do not believe the evaluation services or
fabrication and fitting of oral sleep
apnea appliances by dentists or other
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physicians or non-physician
practitioners would be subject to the
prohibition on payment for dental
services under section 1862(a)(12) or the
payment policy for dental services
inextricably linked to covered services.
However, we seek information regarding
the services associated with the
provision of these appliances and may
consider code creation or other
refinements in the context of the
Medicare physician fee schedule.
Additionally, we note that as described
in section II.C. of this proposed rule,
individuals and groups may nominate
codes that they believe may be
potentially misvalued codes through our
public nomination process for
potentially misvalued codes, which was
established in the CY 2012 PFS final
rule with comment period (76 FR 73026,
73058 through 73059). Individuals
could consider nominating codes
related to oral sleep apnea appliances
for consideration under this process.
Nominations may be submitted to CMS
in one of two ways: via email or through
postal mail. Email submissions should
be sent to the CMS email box 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.
K. Payment for Skin Substitutes
In the CY 2023 PFS proposed rule (87
FR 46027 through 46029), we 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 settings;
(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
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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. After receiving
feedback from commenters requesting
more information on how CMS intends
to achieve a consistent payment
approach for skin substitute products,
we did not finalize any policies in the
CY 2023 PFS final rule.
In alignment with our objectives, in
the CY 2024 PFS final rule, we solicited
comments on different approaches CMS
could use to identify appropriate
practice expense (PE) direct costs for
skin substitute products, such as
reviewing various sources for price
information, including performing
market research, reviewing invoices
submitted by interested parties, or cost
information on Medicare claims.
Discussing these approaches in the CY
2024 PFS final rule provided interested
parties with more details about payment
mechanisms CMS is considering under
our PFS ratesetting methodology.
The CY 2024 PFS proposed rule did
not contain a specific proposal for
changing how skin substitute products
are paid under the PFS; however, we
continue to pursue our objectives for
refining skin substitute payment
policies under Medicare, as mentioned
above. More specifically, we continue
examining ways to treat skin substitute
products as incident-to supplies under
the PFS ratesetting methodology.
Additionally, we believe continuing this
dialogue with interested parties on
payment for skin substitute products
will help inform potential policy
changes for future rulemaking.
We recognize that skin substitute
products may vary in composition, size,
and applicability and will continue to
consider these distinct characteristics in
proposing a consistent payment
approach and policy. We also note an
increase in HCPCS Level II coding
request applications for newly
developed skin substitute products and
are considering broadly all of our
relevant payment policies. Such
policies, for example, include the
discarded drug refund policy and the
Part B drug inflation rebate policy and
how these policies may align with the
usage and payment for skin substitute
products. In the CY 2024 PFS final rule
(88 FR 79060 through 79061), we
finalized that billing and payment codes
that describe products currently referred
to as skin substitutes are not counted for
identifying refundable drugs for
calendar quarters during 2023 and 2024.
While we continue to consider making
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changes to the Medicare Part B payment
policies for such products, similar to
last year, for CY 2025, we are proposing
that billing and payment codes that
describe products currently referred to
as skin substitutes would not be
counted for purposes of identifying
refundable drugs for calendar quarters
in 2025. We plan to revisit discarded
drug refund obligations for skin
substitutes in future rulemaking. In
section III.I. of this proposed rule, CMS
is proposing to codify existing policy by
including products currently referred to
as skin substitutes on the list of product
categories that are not considered Part B
rebatable drugs in proposed
§ 427.101(b)(5).
III. Other Provisions of the Proposed
Rule
A. Drugs and Biological Products Paid
Under Medicare Part B
1. 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
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 (hereinafter referred to as
‘‘refundable drug’’) for calendar quarters
beginning January 1, 2023.
In the CY 2023 PFS final rule (87 FR
69710 through 69734), we finalized
many policies to implement this
provision. First, we finalized the
requirement that billing providers and
suppliers report the JW modifier for all
separately payable drugs and biologicals
(hereinafter referred to as ‘‘drugs’’) with
discarded drug amounts from single use
vials or single use packages payable
under Part B, beginning January 1, 2023
(87 FR 69719). We also finalized the
requirement that billing providers and
suppliers report the JZ modifier for all
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). After the issuance of
the CY 2023 PFS final rule, CMS
published a JW Modifier and JZ
Modifier Policy Frequently Asked
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Questions (FAQ) document 236 to
provide further guidance on the correct
use of these modifiers.
Second, we adopted a definition of
‘‘refundable single-dose container or
single-use package drug’’ at § 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 for which payment
has been made under Part B for fewer
than 18 months.
Third, regarding reports to
manufacturers, we specified that we
would send reports (including
information described in section
1847A(h)(1) of the Act) for each
calendar quarter, on an annual basis, to
each manufacturer of a refundable drug
(87 FR 69726).
Fourth, we finalized how the refund
amount will be calculated, which is
specified in regulation at § 414.940 (87
FR 69731). We stated we would issue a
preliminary report based on available
claims data from the first two quarters
of CY 2023 to provide manufacturers
information regarding discarded
amounts of refundable drugs prior to the
initial refund report (87 FR 69725). In
these reports, which were sent in
December of 2023, we included
preliminary information on estimated
discarded amounts of refundable drugs
for each labeler code based on available
claims data from the first 2 quarters of
CY 2023 for any refundable drug for
which discarded units were billed using
the JW modifier. More information
about discarded drugs, including the
discarded drug refund and the JW and
JZ modifier policy, can be found at
https://www.cms.gov/medicare/
payment/part-b-drugs/discarded-drugs.
Fifth, we addressed drugs with
unique circumstances for which we can,
through notice-and-comment
rulemaking, increase the applicable
percentage otherwise applicable for
determining the refund. 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. We adopted an increased
applicable percentage of 35 percent for
drugs reconstituted with a hydrogel and
with variable dosing based on patient236 https://www.cms.gov/medicare/medicare-feefor-service-payment/hospitaloutpatientpps/
downloads/jw-modifier-faqs.pdf.
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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).
In the CY 2024 PFS final rule (88 FR
79047 through 79064), we finalized the
date of the initial refund 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 finalized that drugs
separately payable under Part B from
single-dose containers that are furnished
by a supplier who is not administering
the drug are required to be billed with
the JZ modifier, since we believe it is
unreasonable to collect discarded drug
data from beneficiaries. We were
concerned that claim rejections may
occur in the absence of a claims
modifier to designate that a drug was
dispensed, but not administered, by the
billing supplier.
b. Application for Increased Applicable
Percentage
Section 1847A(h)(3)(B)(ii) of the Act
permits the Secretary to increase the
applicable percentage for a refundable
drug that has unique circumstances
through notice and comment
rulemaking. In the CY 2024 PFS final
rule (88 FR 79057 through 79060), we
finalized an application process (CMS–
10835, OMB 0938–1435) by which
manufacturers could apply for an
increased applicable percentage for a
drug and may request that we consider
an individual drug to have unique
circumstances for which an increased
applicable percentage is appropriate.
We explained that manufacturers could
benefit from a formal process through
which they can provide information,
including that which may not be
publicly available, 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
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increased by virtue of its unique
circumstances. We finalized the
application deadline of February 1 of
each year, adopted a deadline of August
1 for the FDA-approval of the drug and
the deadline for notifying and
submitting the FDA-approved label to
CMS of September 1 of the year before
the year in which the increased
applicable percentages would apply. We
codified this process in regulation at
§ 414.940(e). The application process
requires the applicant to provide a
written request comprising FDAapproved labeling for the drug;
justification for the consideration of an
increased applicable percentage based
on such unique circumstances; and
justification for the requested increase
in the applicable percentage.
We received one application for
increased applicable percentage for CY
2025 from the manufacturer of Leukine®
(sargramostim). Leukine® is a leukocyte
growth factor that is primarily used in
hematological malignancies to increase
white blood cell counts. The applicant
submitted the information required
under § 414.940(e)(1), including its
justification for consideration for
increased applicable percentage, and
justification for the requested applicable
percentage of 72 percent. The applicant
did not submit FDA-approved labeling
for the drug for the particular adjuvant
uses described in the application
(further described below in this
paragraph) due to ongoing cancer
vaccine adjuvant trials. The applicant
states that there are several
manufacturers in late-stage (Phase II and
Phase III) development using Leukine®
as a vaccine adjuvant in oncology
indications, specifically in stimulating
the immune response of dendritic cells
when used alongside these vaccines.
Cancer treatment vaccines are different
from the vaccines that work against
viruses (for example, influenza). These
vaccines try to get the immune system
to mount an attack against cancer cells
in the body. Instead of preventing
disease, they are meant to get the
immune system to attack a disease that
already exists.237 The applicant stated
that it has no ownership stake in the
development of these vaccines and does
not possess control or influence over the
design and execution of the clinical
trials. The estimated completion dates
for Phase III clinical trials vary, with the
earliest expected in March 2025 238 and
the latest in March 2029.239 The
237 https://www.cancer.org/cancer/managingcancer/treatment-types/immunotherapy/cancervaccines.html.
238 https://clinicaltrials.gov/study/NCT04229979.
239 https://clinicaltrials.gov/study/NCT05100641.
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adjuvant use of Leukine® in
predetermined dosage introduces a new
use of the drug that is distinct from its
six FDA-approved indications, all of
which have dosages that are based on
body weight or body surface area (BSA).
The adjuvant use dosages of Leukine®
in clinical trials are generally much
smaller than dosages for indications in
the FDA-approved labeling. The
smallest dose of Leukine® used for
vaccine adjuvant purposes of which the
applicant is aware (that is, 70 mcg)
would lead to as much as 72 percent of
the drug being discarded from a singledose 250 mcg lyophilized vial, which is
the only size available commercially.
The applicant suggested that if use of
these small doses were to become more
common, the percentage of discarded
units could increase the discarded drug
refund amount that could be owed by
the applicant, even though the applicant
lacks control or knowledge of the
potential variability of the discarded
amounts that may occur if Leukine®
were used for such purposes. If an FDA
approval for adjuvant use of Leukine®
were to occur by another manufacturer,
the available presentations of Leukine®
would likely not be optimized for the
small doses being studied in these trials.
As part of CMS’s review of the
application, we analyzed existing claims
data from the first quarter of 2023
through the first quarter of 2024 and
found the percentage of units discarded
for the Healthcare Common Procedure
Coding System (HCPCS) code for
Leukine® (J2820) ranged from 1.2
percent to 3.8 percent, which is below
the applicable percentage of 10 percent.
Since we do not yet know the impact of
a new adjuvant indication with a type
of immunotherapy commonly referred
to as cancer vaccines 240 on the current
percentage of units discarded, we are
not proposing an increased applicable
percentage without additional
information. Because it is not yet known
whether Leukine® will be approved for
additional indications with varying
dosage requirements and the
information provided by the applicant;
and available data does not provide
enough information for CMS to
determine whether Leukine® has unique
circumstances that would prompt an
increase in the applicable percentage,
we are not proposing an increase in the
applicable percentage for the drug at
this time.
The applicant may reapply in a future
application cycle when more
information becomes available.
240 https://www.cancerresearch.org/treatmenttypes/cancer-vaccines.
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c. Clarifications for the Definition of
Refundable Single-Dose Container or
Single-Use Package Drug
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(1) Exclusions for Drugs for Which
Payment Has Been Made Under Part B
for Fewer Than 18 Months
Section 1847A(h)(8)(B)(iii) of the Act
excludes from the definition of
refundable drug a drug approved or
licensed by FDA on or after November
15, 2021, and for which payment has
been made under Part B for fewer than
18 months. This is codified in the
definition of refundable single-dose
container or single-use package drug in
§ 414.902. In the CY 2023 PFS final rule
(87 FR 69720 through 69731), we
finalized that the 18-month period
begins on the first day of the calendar
quarter following the date of first sale as
reported to CMS for the first National
Drug Code (NDC) assigned to the HCPCS
code. We expected that the first date of
sale would approximate the date of
payment of the first Part B claim, and
we finalized that we would use the first
date of sale because it is more
operationally feasible than identifying
the date when the first Part B claim was
paid for a new drug. We did not receive
any opposing comments to this
approach when the policy was proposed
(87 FR 69719 through 69724). Since
then, however, we have found one
instance where the date of first sale for
a drug, as reported to CMS, does not
adequately approximate the first date for
which payment was made under Part B.
We propose that, while we would
continue to use the first date of sale
reported to CMS for most refundable
drugs, we would use the date on which
the drug is first paid under Part B if the
date of first sale as reported to CMS
does not adequately approximate the
first date of payment under Part B due
to an applicable National Coverage
Determination (NCD). Under the
exception, the first date for which the
drug is actually paid under Part B (not
the date of first sale) would be used to
determine the beginning of the 18month exclusion period.
For example, in the case of Leqembi®
(lecanemab-irmb), the second drug
targeting cerebral amyloid-beta plaques
in Alzheimer’s disease to receive FDA
approval, the first date of sale reported
to CMS via the Average Sales Price
(ASP) portal was in January 2023, as it
was marketed and sold under
accelerated approval granted on January
6, 2023. However, because Leqembi® is
subject to the NCD for Monoclonal
Antibodies Directed Against Amyloid
for the Treatment of Alzheimer’s
Disease under coverage with evidence
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development (CED),241 and because
Leqembi® was initially marketed and
sold under accelerated approval,
Leqembi® coverage under Part B
required the product to be furnished in
a randomized controlled trial (RCT)
conducted under an investigational new
drug (IND) application.242 In public
comments on the CY 2024 proposed
rule, the manufacturer of Leqembi®
explained that Leqembi®’s Phase III
confirmatory trial was already fully
enrolled and complete prior to FDA
granting accelerated approval, and as
such, there was no RCT in which to
enroll Medicare beneficiaries. Leqembi®
received traditional approval on July 6,
2023. The first Part B payments for
Leqembi® did not occur until after
traditional FDA approval of the drug on
July 6, 2023, and Medicare paid for the
drug beginning that month in CED
studies using a registry.243 Under
policies finalized in the CY 2023 PFS
final rule, the 18-month exclusion
period for Leqembi® would begin on
April 1, 2023, which marks the first day
of the calendar quarter after the drug’s
first date of sale as reported to CMS in
January 2023. We believe that, in this
situation, our current policy of using the
date of first sale as reported in ASP data
does not adequately approximate the
beginning of the 18-month period for
which payment has been made for the
drug under Part B.
Under this proposed rule, the 18month exclusion for Leqembi® would be
October 1, 2023, through March 31,
2025 (that is, six full calendar quarters
following the date that the drug was first
paid under Medicare Part B).
To maintain operational feasibility of
this provision and better align the
policy with statutory language when the
date of first sale reported to CMS does
not adequately approximate the date of
first payment under Medicare Part B, we
are proposing to amend the exclusions
in the definition of refundable singledose container or single-use package
drug at § 414.902. We note that we are
also proposing to revise the structure of
the definition of Refundable single-dose
container or single-use package drug
and as part of that restructuring, we are
proposing that exclusions would be
defined at paragraph (2) of the
definition. Moreover, we are proposing
241 Section 200.3 of the Medicare National
Coverage Determinations Manual.
242 https://www.cms.gov/medicare/coverage/
coverage-evidence-development/monoclonalantibodies-directed-against-amyloid-treatmentalzheimers-disease-ad.
243 https://www.cms.gov/newsroom/pressreleases/statement-broader-medicare-coverageleqembi-available-following-fda-traditionalapproval.
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to add a fourth exclusion to paragraph
(2) to address drugs for which the date
of first sale does not adequately
approximate the first date of payment
under Part B due to an applicable NCD.
We anticipate that instances of
inadequately approximating the date of
first payment under Medicare Part B
based on the date of first sale due to an
applicable NCD will be rare, as coverage
of a drug under Part B is not often
restricted by an NCD.
(2) Clarification for Identifying SingleDose Containers
In the CY 2023 PFS final rule (87 FR
69719), we finalized that the definition
of refundable drug would apply to drugs
paid under Medicare Part B (that is,
under any payment methodology) that
are described in FDA-approved labeling
as being supplied in a ‘‘single-dose’’
container or ‘‘single-use’’ package. This
definition also includes drugs described
in FDA-approved labeling as a part of a
‘‘kit’’ that is intended for a single dose
or single use. We also finalized that for
a drug to meet the definition of
refundable drug, all NDCs assigned to
the drug’s billing and payment code
must be single-dose containers, as
described in each product’s labeling.
During our analysis in identifying
refundable drugs for the preliminary
reports (which are based on available
JW modifier data from the first and
second quarters of 2023), we learned
that some product labeling 244 does not
specify the package type terms (for
example, whether the product is
supplied in a single-dose or single-use
package or a multiple-dose preparation).
This may occur in drugs that were
approved prior to October 2018 because
at that time, FDA issued guidance 245
regarding the selection of the
appropriate package terms to address
bacterial and viral infections among
patients resulting from improper use of
single-dose containers such as vials,
ampules, and prefilled syringes. The
guidance defines a single-dose container
as a container of a sterile medication for
parenteral administration (injection or
infusion) that is not required to meet the
antimicrobial effectiveness testing
requirements. The guidance further
states a single-dose container is
designed for use with a single patient as
a single injection/infusion and, when
space permits, the label should include
the correct package type term and
appropriate discard statements. Discard
statements include instruction for
244 ‘‘Product labeling’’ in this document means
the container label, carton labeling, or prescribing
information.
245 https://www.fda.gov/media/117883/download.
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discarding or, if appropriate, storage
guidance for drugs remaining after
preparation. The guidance defines a
multiple-dose container as a container
of sterile medication for parenteral
administration that has met
antimicrobial effectiveness testing
requirements or is excluded from such
testing requirements. In addition, the
guidance defines the term ‘‘singlepatient-use’’ container, which describes
a package that contains multiple doses
of an injectable medical product that is
intended to be used in a single patient.
Some drugs approved prior to the
release of this guidance (that is, those
prior to October 2018) and some Orphan
drugs do not include the package type
terms and explicit discard statements.
Examples of drugs without the package
type terms and discard statements
include certain manufacturers of
digoxin (approved in 1954), oxytocin
(approved in 1980), diphenhydramine
(approved in 1982), phenobarbital
(orphan drug without FDA approval).
Several of these drugs are available in
small containers with only a few mL of
labeled drug in the containers.
In this proposed rule, we are
proposing to include injectable drugs
with a labeled volume of 2 mL or less
and that lack the package type terms
and explicit discard statements in their
product labeling to be single-dose
containers in the definition of
refundable single-dose container or
single-use package drugs. We identified
2 mL as a threshold for this proposal for
several reasons. For intramuscular
administration, the maximum volume
administered at one time for
diphenhydramine and digoxin is less
than or equal to 2 mL. We also note that
for adults, the maximum volume 246 for
intramuscular administration is
typically limited to 3 mL. For drugs
administered intravenously and
supplied in containers containing 2 mL
or less, like digoxin and phenobarbital,
dosages are calculated based on body
weight, potentially leading to discarded
amounts. We believe that preparation of
these drugs would likely be used for a
single dose based on the range of dose
sizes for these drugs and the amount of
drug in the container. In other words, it
is unlikely that more than one dose
could be prepared from the amount of
drug in the container.
Another category of drugs approved
before 2018 that lack discard statements
246 Open Resources for Nursing (Open RN);
Ernstmeyer K, Christman E, editors. Nursing Skills
[internet]. 2nd edition. Eau Claire (WI): Chippewa
Valley Technical College; 2023. Chapter 18
Administration of Parenteral Medications.
Available from https://www.ncbi.nlm.nih.gov/
books/NBK596739/.
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is drugs contained in ampules (also
spelled as ampoules or ampuls,
hereinafter referred to as ‘‘ampules’’).
The term ampule is an airtight vial
made of glass, plastic, metal, or any
combination of these materials.247
Examples of drugs currently contained
in ampules include epinephrine
(approved in 1939), lidocaine
hydrochloride (1948), dicyclomine
(1950), digoxin (1954), chlorpromazine
(1957), fentanyl citrate (1968),
promethazine (1973), alprostadil (1981),
nalbuphine (1993), and tacrolimus
(1994). Drugs contained in ampules are
accessed by breaking the concaved part
(‘‘the neck’’), and the content should be
passed through a sterile filter to remove
any residual glass particles.248
Therefore, we are proposing to amend
the definition of refundable single-dose
container or single-use package drug to
include drugs contained in ampules and
for which there is no discard statement.
We are proposing to classify drugs
supplied in ampules to be drugs in
single-dose containers for purposes of
this discarded drug policy because this
approach would be consistent with the
description of single-dose container in
the October 2018 FDA guidance. We
note that some drugs contained in
ampules may be excluded from the
definition of refundable drug under
section 1847A(h)(8)(B)(ii) of the Act
because dosage and administration
instructions included in the product
labeling require filtration during the
drug preparation process, prior to
dilution and administration, and require
that any unused portion of such drug
after the filtration process be discarded
after the completion of such filtration
process. This exclusion would still be
applicable for ampules that can
demonstrate that they meet that
exclusion. However, this is not the case
for the product labeling of all drugs
contained in ampules.
In summary, we are proposing to
amend the definition of Refundable
single-dose container or single-use
package drug at § 414.902 by including
‘‘single-patient-use container’’ as a
package type term and adding three
types of products that may be
considered refundable single-dose
container or single-use package drugs
under paragraph (1). These are:
(1) Product furnished from a singledose container or single-use package
based on FDA-approved labeling or
product information.
(2) Product furnished from an ampule
for which product labeling does not
247 40
CFR 273.9.
Compounding—Sterile
Preparations. USP–NF 2023. November 1, 2023.
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have discard statement or language
indicating the package type term, like
‘‘single-dose container,’’ ‘‘single-use
package,’’ ‘‘multiple-dose container,’’ or
‘‘single-patient-use container’’.
(3) Product furnished from a container
with a total labeled volume 2 ml or less
for which product labeling does not
have language indicating the package
type term, like ‘‘single-dose container,’’
‘‘single-use package,’’ ‘‘multiple-dose
container,’’ or ‘‘single-patient-use
container’’.
As noted above, we are also revising
the organization of this definition in the
regulatory text. We welcome comments
on these proposals.
(3) Skin Substitutes
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. In the CY 2024 PFS final
rule (88 FR 79060 through 79061), we
finalized that billing and payment codes
that describe products currently referred
to as skin substitutes are not counted for
purposes of identifying refundable
drugs for calendar quarters during 2023
and 2024. While we continue to
consider making changes to the
Medicare Part B payment policies for
such products, similar to last year, for
CY 2025, we are proposing again 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 in 2025. We plan to
revisit discarded drug refund
obligations for skin substitutes in future
rulemaking. More information regarding
the payment of skin substitutes is
available in section II.K. of this
proposed rule.
d. Discarded Amounts
Effective January 1, 2017, providers
and suppliers were required to report
the JW modifier on all claims that bill
for drugs separately payable under
Medicare Part B with unused and
discarded amounts (that is, discarded
amounts) from single-dose containers or
single-use packages. In the CY 2023
PFS, we finalized the requirement to use
the JW modifier for single-dose
container drugs that are separately
payable under Part B, and we finalized
the use of the JW modifier (or any
successor modifier that includes the
same data) to identify discarded billing
units of a billing and payment code for
the purpose of calculating the refund
amount as described in section
1847A(h)(3) of the Act. In that final rule,
to align with the JW modifier policy, we
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also finalized the requirement that,
beginning July 1, 2023, the JZ modifier
is required when there are no discarded
amounts of a single-dose container drug
for which the JW modifier would be
required if there were discarded
amounts.
In the CY 2023 PFS final rule (87 FR
69723), we discussed the applicability
of the JW and JZ modifiers 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, we stated that the reporting
requirement does not apply to drugs
that are self-administered by a patient or
caregiver in the patient’s home. In the
JW Modifier and JZ Modifier Policy
FAQ document 249 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 or JZ
modifier.
Then, in the CY 2024 PFS final rule
(88 FR 79062), we finalized a change to
this policy, such 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. This
meant that the JW modifier would not
be used on these claims. As we stated
in that rule, in the absence of a claims
modifier to designate that a drug was
dispensed, but not administered, by the
billing supplier (as finalized in the CY
2023 PFS), we were concerned that
claims rejections may occur. Therefore,
this change in policy required the JZ
modifier on all such claims to ensure
claims rejections did not occur
unnecessarily. On October 16, 2023, we
updated the JW Modifier and JZ
Modifier Policy FAQ document to
include the requirement of the JZ
modifier by the supplier.
However, after this policy was
finalized, interested parties have
requested further clarification on how to
appropriately bill for discarded amounts
from single-dose containers when there
are amounts discarded during
preparation by the billing supplier who
is not administering the drug. To
provide additional clarity, we are now
proposing to require the JW modifier if
a billing supplier is not administering a
drug, but there are amounts discarded
during the preparation process before
supplying the drug to the patient. Such
a supplier would report the JZ modifier
if no amounts were discarded during the
249 https://www.cms.gov/medicare/medicare-feefor-service-payment/hospitaloutpatientpps/
downloads/jw-modifier-faqs.pdf.
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preparation process before supplying
the drug to the patient.
We believe this proposal is
appropriate because drug preparation
occurs before supplying a drug to the
beneficiary and the billing supplier can
determine the discarded amount at the
site of drug preparation. These
discarded units should be billed using
the JW modifier in the same way as a
drug that is administered incident-to
physician service. In addition, suppliers
and other interested parties have
expressed that suppliers are accustomed
to using the JW modifier in this context
already. Therefore, we propose to
require the JW modifier if a billing
supplier is not administering a drug, but
there are amounts discarded during the
preparation process before supplying
the drug to the patient. For example, if
a billing supplier prepares a dose from
a single-dose vial labeled as containing
a total of 50 billing units such that 45
billing units of the drug are used in the
prepared dose and 5 billing units are
discarded during preparation, and then
the drug is supplied to the patient (but
not administered by the supplier), the
claim should be submitted on two lines:
45 units (without a modifier) and 5
units with the JW modifier. We reiterate
that suppliers who dispense a drug, but
do not actually administer the drug, are
not expected to monitor or bill for
discarded amounts that are discarded
after the drug is supplied because they
are not at the site of administration to
measure discarded amounts. For
example, if the patient who was
supplied the above dose with 45 billing
units subsequently only receives 35 of
those billing units, the above billing
supplier would not be expected to
account for the 10 subsequently
discarded billing units on the claim.
We welcome comments on this
proposal.
2. Payment Limit Calculation When
Manufacturers Report Negative or Zero
Average Sales Price (ASP) Data
(§ 414.904)
a. Background
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 furnished via a covered item
of durable medical equipment (DME)
(section 1861(s)(6) of the Act), and other
drugs for which coverage is specified by
statute (for example, certain vaccines
described in sections 1861(s)(10)(A) and
(B) of the Act). Payment limits for most
drugs separately payable under
Medicare Part B are determined using
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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. If CMS determines a payment
limit for a drug, it is published in the
ASP pricing file or Not Otherwise
Classified (NOC) pricing file,250 which
are both updated quarterly.
CMS generally calculates the payment
limits for drugs payable under Part B on
a quarterly basis using the
manufacturer’s ASP (as defined in
§ 414.902). Manufacturers are required
to report ASP to CMS pursuant to
sections 1847A(f)(2) and 1927(b)(3) of
the Act. Manufacturers are instructed to
calculate ASP in accordance with
section 1847A(c) of the Act and
§ 414.804(a).
For each NDC, in most cases, the
manufacturer’s ASP is a positive dollar
value, along with a positive number of
units sold (hereinafter referred to as
‘‘positive manufacturer’s ASP data’’).
However, sometimes the reported data
is not positive manufacturer’s ASP data.
Specifically, a manufacturer could
report that an NDC has a negative or
zero-dollar value for the manufacturer’s
ASP with a positive, negative, or zero
number of units sold, or a positive
dollar value for the manufacturer’s ASP
with a negative or zero number of units
sold (each of these scenarios is
hereinafter referred to as ‘‘negative or
zero manufacturer’s ASP data’’). Such
negative or zero manufacturer’s ASP
data could occur because of lagged
discounts, units returned to the
manufacturer, drug shortages,
discontinuation of a drug, or other
reasons that are not known to CMS.
Negative or zero manufacturer’s ASP
data can occur when a manufacturer
calculates its ASP in accordance with
section 1847A of the Act.
First, section 1847A(c)(3) of the Act
requires that the manufacturer’s
calculation of its ASP for an NDC must
include volume discounts, prompt pay
discounts, cash discounts, free goods
that are contingent on any purchase
requirement, chargebacks, and rebates
(other than rebates under the Medicaid
drug rebate program or the Medicare
Prescription Drug Inflation Rebate
Program) (hereinafter referred to as
‘‘price concessions’’). Second, section
1847A(c)(5)(A) of the Act requires each
manufacturer to apply a methodology
based on a 12-month rolling average for
the manufacturer to estimate costs
attributable to price concessions if there
is a lag in the reporting of the
information on rebates and chargebacks
250 https://www.cms.gov/medicare/payment/partb-drugs/asp-pricing-files.
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under section 1847A(c)(3) of the Act.
These provisions may result in the
inclusion of large price concessions
from a quarter or quarters with a higher
sales price prior to price concessions in
the ASP calculation for a subsequent
quarter with a much lower sales price,
which can result in negative dollar
value ASP. The same situation could
happen in a quarter if more units were
returned to the manufacturer than are
sold, which can result in a negative
dollar value ASP as well as a negative
number of units sold. The requirement
to use a rolling average for lagged price
concessions is codified at
§ 414.804(a)(3), which states that, to the
extent data on price concessions are
available on a lagged basis, the
manufacturer must estimate its ASP in
accordance with the described
methodology in that paragraph. In
certain instances, as stated above, lagged
price concessions can lead to negative
or zero manufacturer’s ASP data.
In 2022, the U.S. Department of
Health and Human Services Office of
Inspector General (OIG) issued a report
assessing potential inaccuracies in
manufacturer reporting of ASP and
noted that manufacturers believe
additional guidance may be needed to
reduce distortions and inconsistencies
in the calculation of payment limits.251
The report found that several
manufacturers would like additional
guidance regarding reporting of negative
ASP data and how CMS uses negative
ASP data in payment limit calculations.
CMS concurred with the OIG’s
recommendation to actively review
current guidance and determine
whether additional guidance would
ensure more accurate and consistent
ASP calculations.
Accordingly, we reviewed our current
guidance and determined that it is
appropriate for us to provide additional
guidance regarding how CMS will
handle payment for drugs separately
payable under Part B when the
manufacturer’s ASP for at least one NDC
within the billing and payment code
(that is, HCPCS code) of the drug is
negative or zero. Currently, when all
NDCs assigned to a HCPCS code have
negative or zero manufacturer’s ASP
data, CMS establishes the payment limit
in other ways. As appropriate given the
data available for a drug, CMS will
either calculate a payment limit for a
billing and payment code based on
other applicable and available pricing
data or not include a payment limit for
the billing and payment code on the
ASP pricing file. When a payment limit
251 OEI–BL–21–00330. https://oig.hhs.gov/oei/
reports/OEI-BL-21-00330.asp.
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for a drug separately payable under Part
B is not included in the ASP pricing
file, the payment limit is based on either
the published or Wholesale Acquisition
Cost (WAC) or invoice pricing, as
described in section 20.1.3, Chapter 17
of the Medicare Claims Processing
Manual.252
CMS previously contemplated how to
set a payment limit in certain situations
in which ASP data is ‘‘not available’’ for
multiple source drugs. In the CY 2011
PFS final rule (75 FR 73461 through
73465), CMS addressed situations in
which ASP data for some, but not all,
NDCs in a multiple source drug billing
and payment code are not available for
the calculation of an ASP payment limit
(for example, if a manufacturer’s entire
submission of data was not received or
manufacturer’s ASP data for specific
NDCs was not reported).253 In that rule,
we finalized a process, consistent with
authority in section 1847A(c)(5)(B) of
the Act, to update payment limits based
on the manufacturer’s ASP reported for
the most recent quarter for which data
is available. We specified that if
manufacturer’s ASP data is not available
for some but not all NDCs in a multiple
source drug billing and payment code
prior to the publication deadline for
quarterly payment limits and such
unavailability of manufacturer’s ASP
data significantly changes the quarterly
payment limit for the billing and
payment code when compared to the
prior quarter’s payment limit, CMS will
calculate the payment limit by carrying
over the most recent available
manufacturer’s ASP price from a
previous quarter for an NDC, adjusted
by the weighted average of the change
in the manufacturer’s ASPs for the
NDCs that were reported for both the
most recently available previous quarter
and the current quarter, and codified
this policy in § 414.904(i).254 In that
final rule, we explained that such
circumstances are limited to when a
manufacturer’s data for a multiple
source drug product with sales during a
quarter is missing, and efforts to obtain
manufacturer reported ASP data before
Medicare ASP payment limits
publication deadlines have not been
successful. We continue to believe that
this process, which we apply in cases
ASP data is ‘‘not available’’ for some but
not all NDCs associated with a multiple
252 https://www.cms.gov/%E2%80%8B
Regulations-and-Guidance/%E2%80%8BGuidance/
%E2%80%8BManuals/%E2%80%8BDownloads/
%E2%80%8Bclm104c17.pdf.
253 https://www.govinfo.gov/content/pkg/FR2010-11-29/pdf/2010-27969.pdf.
254 https://www.ecfr.gov/current/title-42/part-414/
section-414.904#p-414.904(i).
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source billing and payment code, is
appropriate.
b. Approach to Payment Limit
Calculations When Manufacturer’s ASP
Data is Not Available
As described in the previous section,
we determined that it is appropriate for
CMS to provide additional guidance
regarding how we will handle payment
for drugs separately payable under Part
B when the reported manufacturer’s
ASP for at least one NDC within the
billing and payment code (that is,
HCPCS code) of the drug is negative or
zero (that is, has negative or zero
manufacturer’s ASP data). As detailed
below, we are proposing to consider
ASP data to be not ‘‘available’’ for the
purposes of calculating a payment limit
in circumstances in which negative or
zero manufacturer’s ASP data is
reported, consistent with section
1847A(c)(5)(B) of the Act. We are also
proposing how CMS would calculate a
payment limit in these circumstances,
consistent with section 1847A(c)(5)(B)
of the Act.
Our current policy does not address
how payment limits are calculated for
several situations in which a drug
separately payable under Part B does
not have available ASP data. The set of
situations in which this might occur
include circumstances in which either
some or all NDCs for a billing and
payment code have a negative or zero
manufacturer’s ASP data; in which
negative or zero manufacturer’s ASP
data is reported for a drug which has
been discontinued; and vary further
depending on whether a drug is
multiple source or single source (both as
defined in § 414.902). In each of these
circumstances, there are various other
pricing data available that we believe
can appropriately be used to calculate a
payment limit.
Therefore, we are proposing,
consistent with section 1847A(c)(5)(B)
of the Act, a methodology for
calculating payment limits in certain
circumstances based on manufacturer’s
ASP for the most recent quarter for
which data is available. Specifically, we
propose to specify that positive
manufacturer’s ASP data are considered
‘‘available’’ and that negative or zero
manufacturer’s ASP data are considered
‘‘not available’’ for purpose of CMS
calculating a payment limit under the
statute. We believe it is appropriate to
consider negative or zero manufacturer’s
ASP data to be not available because if
used to calculate a payment limit, this
data can result in a negative or zero
payment limit, which would require
CMS to collect payment from providers
and suppliers for a drug, rather than
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make payment for a drug. Negative or
zero payment limits for a drug are not
reasonable because Medicare does not
expect to collect payment from
providers and suppliers for their
provision of separately payable drugs.
Therefore, we are proposing to specify
the methodology we will use for
calculating the payment limit in such
circumstances to ensure reasonable
payment amounts based on the best
available data for separately payable
drugs. Below, we propose how payment
limits would be determined using
available ASP data for each scenario.
c. Single and Multiple Source Drugs
When Negative or Zero Manufacturer’s
ASP Data Is Reported for Some, But Not
All NDCs
In the case that a drug separately
payable under Part B has negative or
zero manufacturer’s ASP data reported
for some, but not all, NDCs associated
with a billing and payment code for that
drug, we are proposing to calculate a
payment limit using only NDCs with
positive manufacturer’s ASP data (and
omitting NDCs with negative or zero
manufacturer’s ASP data) for that drug
and propose to codify this at
§ 414.904(i). We are proposing this
policy to apply to both single source
drugs, including biosimilar biological
products, and multiple source drugs.
We believe this is appropriate because
it would result in payment limits based
on the most recent positive
manufacturer’s ASP data reported by
manufacturers with NDCs associated
with a billing and payment code.
However, we note that, as discussed
in section III.A.2.a of this proposed rule,
CMS already has a policy in place for
multiple source drugs for which the
absence of ASP data would result in a
significant change (that is, a 10 percent
or greater change) in the ASP payment
limit compared to the payment limit of
the previous quarter, as finalized in the
CY 2011 PFS final rule (75 FR 73461
through 73465). In that discussion (75
FR 73462), we noted several examples
of situations in which data is not
available to be included in the
calculation of a payment limit, such as
when a manufacturer’s entire
submission was not received or when
the manufacturer’s ASP data for specific
NDCs has not been reported. We do not
intend for our proposed policy to
override that existing policy; rather, we
intend for the proposed policy
described above to address
circumstances not addressed in that
rulemaking (that is, we intend to
address circumstances of single source
drugs when negative or zero
manufacturer’s ASP data is reported for
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some, but not all NDCs, and of multiple
source drugs when negative or zero
manufacturer’s ASP data is reported for
some, but not all NDCs and the absence
of such data from the calculation of the
payment limit does not result in a
significant change in the payment limit
compared to the payment limit of the
previous quarter) and thus fill a policy
gap. In addition, the circumstances we
provided as examples in which ASP
data is not available in the CY 2011 PFS
final rule continue to be circumstances
we consider manufacturer’s ASP data
not available under current § 414.904(i)
(which we propose to move within
§ 414.904(i) to fit within the structure of
the proposed new set of payment limit
methodologies); but, as noted in section
III.A.2.b, we are expanding what we
consider to be not available to include
circumstances in which negative or zero
manufacturer’s ASP data is reported.
d. Multiple Source Drugs With Only
Negative or Zero Manufacturer’s ASP
Data
In the case of a multiple source drug
(as defined in § 414.902) separately
payable under Part B that has negative
or zero manufacturer’s ASP data
reported for all NDCs associated with a
billing and payment code for that drug
(and at least one NDC for the is actively
being marketed (that is, not
discontinued)), we are proposing to
carry over all positive manufacturer’s
ASP data from the most recently
available previous quarter with positive
manufacturer’s ASP data for at least one
NDC until at least one NDC for the drug
has positive manufacturer’s ASP data
for a quarter. Specifically, we are
proposing to calculate the payment limit
for the applicable quarter using data
from the most recent calendar quarter
for which data is available, i.e., for
which there is positive manufacturer’s
ASP data. We believe this is appropriate
because, similar to the methodology
described in section III.A.2.c, it would
result in payment limits based on the
most recent positive manufacturer’s
ASP data reported by manufacturers
with NDCs associated with a billing and
payment code. Similarly, we believe the
most recent available positive
manufacturer’s ASP data from NDCs
associated with a billing and payment
code are more likely to be reflective of
providers’ acquisition costs for drugs
associated with that billing and
payment code in a given quarter than
other pricing data, and unlikely to result
in challenges to access for these drugs
for providers and beneficiaries.
We note that because section 1847A
of the Act provides for payment limit
calculations that differ between single-
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source drugs (as defined in section
1847A(c)(6)(D) of the Act and § 414.902)
and multiple source drugs (as defined in
section 1847A(c)(6)(C) of the Act and
§ 414.902), we are proposing different
ways to determine payment limits for
each, in cases in which only negative or
zero manufacturer’s ASP data is
reported, to reflect these differences.
Specifically, the payment limit for
single source drugs is described in
section 1847A(b)(1)(B) of the Act; for
multiple source drugs, the payment
limit is described in section
1847A(b)(1)(A) of the Act. The payment
limit for single source drugs is
determined using the lesser of ASP or
WAC; but WAC is not used for multiple
source drugs whose ASP exceeds WAC.
Nonetheless, our proposals for the
calculation of the payment limit for
single source and multiple source drugs
with only negative or zero
manufacturer’s ASP data are consistent
in that, where ASP is used, we propose
to use the most recent available positive
manufacturer’s ASP data from at least
one NDC for the drug. We believe using
similar input data in our calculation of
the payment limit is consistent with our
goal to ensure reasonable payment
amounts based on the best available
data for separately payable drugs.
We are proposing to amend
§ 414.904(i) to include the above
proposal regarding how CMS would
calculate the payment limit in
circumstances in which only negative or
zero manufacturer’s ASP data is
reported for a multiple source drug.
e. Single Source Drugs With Only
Negative or Zero Manufacturer’s ASP
Data, Excluding Biosimilar Biological
Products
In the case of a single source drug,
excluding biosimilar biological products
(both as defined in § 414.902),
separately payable under Part B that has
negative or zero manufacturer’s ASP
data reported for all NDCs associated
with a billing and payment code for that
drug (and at least one NDC for the drug
is actively being marketed (that is, not
discontinued)), we are proposing to set
the payment limit for the given quarter
for the single source drug at the lesser
of the following until at least one NDC
for the drug has positive manufacturer’s
ASP data for a quarter:
• 106 percent of the volume-weighted
average of the most recent available
positive manufacturer’s ASP data from a
previous quarter in which at least one
NDC for the drug has positive
manufacturer’s ASP data for a quarter. If
the payment limit from the quarter with
the most recent available positive
manufacturer’s ASP data was based on
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106 percent of the WAC because of the
application of § 414.904(d)(1), that
payment limit would be carried over; or
• 106 percent of the WAC for the
given quarter. If there is more than one
WAC per billing unit for the drug, the
payment limit would be set using the
lowest WAC per billing unit.
We would only use the lesser of the
positive manufacturer’s ASP or WAC
data from that previous quarter or the
WAC data from the given quarter until
positive manufacturer’s ASP data is
available for a future quarter. Once
positive manufacturer’s ASP data for a
drug is available again in a future
quarter, CMS will have data available to
input into the routinely used
methodologies described in section
1847A(b) of the Act and § 414.904.
As discussed above, we believe it is
appropriate to propose different policies
for determining payment limits for
single and multiple source drugs when
negative or zero manufacturer’s ASP
data is reported because of statutory
differences in the payment limit
calculations.
f. Biosimilars With Only Negative or
Zero Manufacturer’s ASP Data
In circumstances in which negative or
zero manufacturer’s ASP data is
reported for all NDCs for a biosimilar
biological product (defined at § 414.902)
(hereinafter referred to as a
‘‘biosimilar’’) for a given quarter (and at
least one NDC for the biosimilar is
actively being marketed (that is, not
discontinued)), and positive
manufacturer’s ASP data is available for
another biosimilar(s) with the same
reference biological product (hereinafter
referred to as a ‘‘reference product’’) for
the given quarter, we are proposing to
set the payment limit for the given
quarter equal to the sum of the
following until at least one NDC for the
particular biosimilar for which all NDCs
report negative or zero manufacturer’s
ASP data has positive manufacturer’s
ASP data for a quarter:
• The volume-weighted average of the
positive manufacturer’s ASP data from
all other biosimilars with the same
reference product, and
• 6 percent (or 8 percent for
qualifying biosimilar biologicals as
defined in § 414.902, as appropriate) of
the amount determined under section
1847A(b)(4) of the Act for the reference
biological product (as defined in
§ 414.902) for the given quarter.
We believe this is appropriate because
Section 351(i)(2) of the Public Health
Service Act defines the terms biosimilar
and biosimilarity to mean that a
biosimilar is highly similar to its
reference product, notwithstanding
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minor differences in clinically inactive
components, and that there are no
clinically meaningful differences
between the biosimilar and the
reference product in terms of the safety,
purity, and potency of the product. In
addition, biosimilars with the same
reference product likely compete in the
marketplace since both rely on FDA’s
previous determination of safety, purity,
and potency for the reference product
clinical data for approval. For these
reasons, we believe that when a
biosimilar has only negative or zero
manufacturer’s ASP data, the volumeweighted average of positive
manufacturer’s ASP data of biosimilars
with the same reference product would
be an appropriate payment limit for a
biosimilar that, under this proposal,
would be considered to have ASP data
that is not available. As such, we are
proposing to calculate the payment limit
for a biosimilar with only negative or
zero manufacturer’s ASP data based on
the positive manufacturer’s ASP data of
other biosimilars with the same
reference product.
We note that in the CY 2016 PFS final
rule (80 FR 71096 through 71101), we
finalized that we would group all
biosimilars with a common reference
product in a single billing and payment
code with a single payment rate, in a
manner similar to how we price
multiple source or generic drugs
because of the significant similarities
between each biosimilar and its
reference product. In the CY 2018 PFS
final rule (82 FR 53182 through 53187),
we changed the initial policy and
finalized separate coding and payment
for biosimilars. In that final rule, we
stated that that there is a program need
for assigning Part B biosimilars into
separate billing and payment codes;
specifically, that this policy change
addressed concerns about the public
interest in a stronger marketplace,
access to these drugs in the United
States marketplace, and provider and
patient choice and competition. Our
proposal for biosimilars with negative or
zero manufacturer’s ASP data reported
for all NDCs is consistent with the CY
2018 PFS rulemaking, as it would not
result in grouping biosimilars with a
shared reference product in a single
billing and payment code. Rather, it
would allow CMS to calculate an
operationally reasonable payment limit
using positive manufacturer’s ASP data
for highly similar products in limited
instances.
This proposal would also provide
payment limit stability that could help
avoid potential access issues for
providers and beneficiaries that could
otherwise occur if we were to calculate
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a payment limit for a drug with negative
or zero manufacturer’s ASP data that is
far below the provider’s cost for
acquiring the drug. If a biosimilar’s ASP
falls below zero only after several
quarters of declining but still positive
manufacturer’s ASP data, the most
recent positive manufacturer’s ASP data
from a previous quarter for a drug may
be significantly lower than the volumeweighted average of the biosimilars with
the same reference product as the
biosimilar with negative ASP data. In
such a case, the payment limit based on
the ASPs of competitor biosimilars
would be higher than if we were
constrained to use ASP data only from
the biosimilar that has most recently
reported negative or zero manufacturer’s
ASP data. We note that under the
methodology proposed in section
III.A.2.c, in circumstances in which
some, but not all NDCs of a single or
multiple source drug are negative or
zero, we would similarly calculate the
payment limit using only NDCs with
positive manufacturer’s ASP data from
the given quarter and omitting those
that had declined to zero or a negative
value in ASP or sales. Likewise, we
believe that such an approach would
likely result in a payment limit
reflective of providers’ acquisition costs
of biosimilars and be helpful in
avoiding access issues for providers and
beneficiaries.
In circumstances in which negative or
zero manufacturer’s ASP data is
reported for all NDCs for a biosimilar for
a given quarter and either no other
biosimilars have been approved for the
same reference product or no other
biosimilars with the same reference
product report positive manufacturer’s
ASP data for the given quarter, we
propose that we would set the payment
limit for the given quarter equal to the
sum of the following until at least one
NDC for the biosimilar has positive
manufacturer’s ASP data for a quarter:
• The volume-weighted average of the
most recent available positive
manufacturer’s ASP data from a
previous quarter, and
• 6 percent (or 8 percent for
qualifying biosimilar biologicals, as
appropriate) of the amount determined
under section 1847A(b)(4) of the Act for
the reference biological product (as
defined in § 414.902) for the given
quarter.
In situations in which CMS would use
the volume-weighted average of the
most recent available positive
manufacturer’s ASP data from a
previous quarter, we would only use
positive manufacturer’s ASP data from
that previous quarter until positive
manufacturer’s ASP data is available for
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a future quarter. This proposed
methodology is similar to the proposed
methodology for multiple source drugs
and single source drugs that are not
biosimilars when manufacturers report
negative or zero manufacturer’s ASP for
all NDCs.
In addition to the payment
approaches we are proposing for
biosimilars with only negative or zero
manufacturer’s ASP data, we considered
two alternatives for which we are
seeking public comment. Under the first
alternative, the volume-weighted ASP
calculation would include the ASP data
and billing units sold of its reference
product for a given quarter along with
those of the other biosimilars that
reference the same reference product in
the volume-weighted average
calculation. We believe including the
reference product’s data in the blended
calculation for a biosimilar’s payment
limit in the limited circumstance
described could be appropriate in
determining an operationally reasonable
payment limit because the FDA
approval for the biosimilar relies in part
on FDA’s previous determination of
safety, purity, and potency for the
reference product, and the biosimilar
and reference product are necessarily
approved for at least one shared
condition of use, as required under the
351(k) approval pathway; 255 therefore,
the case that the two are comparable is
at least as strong as that for any two
biosimilars with the same reference
product. If it is preferable, as we
propose, to base the payment limit on
the available positive manufacturer’s
ASP data submitted by manufacturers of
market competitor biosimilars (in this
context, biosimilars that reference the
same reference product), then including
the ASP data and billing units sold of
the reference product would also
increase the likelihood that positive
data in such a group is available,
particularly in the case that a reference
product only has one biosimilar. Under
this alternative, the payment limit
would be set equal to the sum of the
volume-weighted average of the positive
manufacturer’s ASP data from all other
biosimilars with the same reference
product and the reference product plus
6 or 8 percent, as appropriate, of the
amount determined under section
1847A(b)(4) of the Act for the reference
biological product for the given quarter.
We are seeking public comments about
whether including ASP data from the
reference product in a variant of the
255 https://www.fda.gov/science-research/fdastem-outreach-education-and-engagement/
development-biosimilar-351k-bla-clinicalpharmacology-study-database.
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proposed calculation would produce a
more appropriate payment limit for a
biosimilar with only negative or zero
manufacturer’s ASP data.
Under the second alternative, we
would calculate payment limits for all
biosimilars with only negative or zero
manufacturer’s ASP data in the manner
described above for biosimilars when
either no other biosimilars have been
approved for the same reference product
or no other biosimilars with the same
reference product report positive
manufacturer’s ASP data for the given
quarter. That is, under this alternative
we would not consider the
manufacturer’s ASP data of other
biosimilars with the same reference
product; rather, we would base the
payment limit of the biosimilar on the
volume-weighted average of the its own
most recent available positive
manufacturer’s ASP data from a
previous quarter and either 6 or 8
percent, as appropriate, of the amount
determined under section 1847A(b)(4)
of the Act for the reference biological
product for the given quarter. We are
interested in comments from interested
parties about whether, and if so, why, it
is preferable for the payment limit to be
calculated only using manufacturer’s
ASP data from the biosimilar that
reports negative or zero manufacturer’s
ASP data in a given quarter.
g. Discontinued Drugs
Generally, for single source drugs and
multiple source drugs for which
negative or zero manufacturer’s ASP
data is reported for all NDCs and for
which all relevant applications (for
example, new drug applications (NDAs),
biologics license applications (BLAs), or
abbreviated new drug applications
(ANDAs)) have a marketing status of
‘‘discontinued’’ on the FDA
website,256 257 we propose that the drug
be priced by MACs consistent with
section 20.1.3 in Chapter 17 of the
Medicare Claims Processing Manual for
developing payment limits for covered
drugs when CMS does not supply the
payment allowance limit on the ASP
drug pricing file.258
Once a drug is discontinued, as
indicated by the marketing status on the
FDA website (either at Drugs@FDA 259
for drugs or the Purple Book 260 for
256 https://www.accessdata.fda.gov/scripts/cder/
daf/index.cfm.
257 https://purplebooksearch.fda.gov/.
258 Medicare Claims Processing Manual Chapter
17, section 20.1.3: https://www.cms.gov/
regulations-and-guidance/guidance/manuals/
downloads/clm104c17.pdf.
259 https://www.accessdata.fda.gov/scripts/cder/
daf/index.cfm.
260 https://www.fda.gov/drugs/therapeuticbiologics-applications-bla/purple-book-lists-
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biologicals), the manufacturer might not
have sales to calculate an ASP and,
therefore, the manufacturer often reports
zero sales for the drug or a negative
number for its calculated ASP or
number of sales. However, even if a
drug has a marketing status of
discontinued on the FDA website, there
may theoretically be available product
that could be billed by the provider
until the expiration date of the last lot
sold for the drug. Relatedly, we have
observed that very few claims are paid
for drugs following their
discontinuation. For these reasons,
setting a payment limit for drugs with
a marketing status of discontinued on
the FDA website is not expected to be
practically useful for claims processing
and is not a prudent use of CMS
resources.
h. Summary
We are proposing to amend
§ 414.904(i) to reflect CMS’s approach to
setting a payment limit in circumstances
in which negative or zero
manufacturer’s ASP data is reported by
a manufacturer for a drug. Specifically,
we are proposing to codify that in cases
where negative or zero manufacturer’s
ASP data is reported for some, but not
all, NDCs of a multiple source drug, we
would calculate the payment limit using
the positive manufacturer’s ASP data
reported for the drug, except for the
existing carryover policy for multiple
source drugs that we would apply when
unavailable data results in a significant
change in the ASP payment limit. We
are proposing to move this carryover
policy for multiple source drugs within
§ 414.904(i) to fit within the structure of
the proposed new set of payment limit
methodologies. We are also proposing to
codify that in the case of a multiple
source drug for which negative or zero
manufacturer’s ASP data is reported for
all NDCs, we would set the payment
limit using the most recent available
positive manufacturer’s ASP data from a
previous quarter until at least one NDC
for the drug has positive manufacturer’s
ASP data for a quarter.
We are proposing to codify that in
cases where negative or zero
manufacturer’s ASP data is reported for
some, but not all, NDCs of a single
source drug that is not a biosimilar, we
would calculate the payment limit using
the positive manufacturer’s ASP data
reported for the drug. We are proposing
to codify that for single source drugs
that are not biosimilars with all negative
or zero manufacturer’s ASP data for a
given quarter, the payment limit would
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be, until at least one NDC for the drug
has positive manufacturer’s ASP data
for a quarter, the lesser of 106 percent
of the volume-weighted average of the
most recent available positive
manufacturer’s ASP data for at least one
NDC from a previous quarter and 106
percent of the WAC, and we would use
106 percent of the lowest WAC per
billing unit if there is more than one
WAC per billing unit available.
We are also proposing to codify that
in cases where negative or zero
manufacturer’s ASP data is reported for
some, but not all, NDCs of a biosimilar,
we would calculate the payment limit
using the positive manufacturer’s ASP
data reported for the biosimilar. Lastly,
we are proposing to codify two
scenarios when the manufacturer
reports negative or zero manufacturer’s
ASP for all NDCs for a biosimilar for a
given quarter:
• When positive manufacturer’s ASP
data is available for another
biosimilar(s) with the same reference
product for the given quarter, we are
proposing to set the payment limit equal
to the sum of the volume-weighted
average of the positive manufacturer’s
ASP data from all other biosimilars with
the same reference product plus 6
percent (or 8 percent for a qualifying
biosimilar biological) of the amount
determined under section 1847A(b)(4)
of the Act for the reference biological
product for the given quarter; and
• When either no other biosimilars
have been approved for the same
reference product or no other
biosimilars with the same reference
product report positive manufacturer’s
ASP data for the given quarter, we are
proposing to set the payment limit equal
to the sum of the volume-weighted
average of the most recent available
positive manufacturer’s ASP data from a
previous quarter plus 6 percent (or 8
percent for a qualifying biosimilar
biological) of the amount determined
under section 1847A(b)(4) of the Act for
the reference biological product for the
given quarter.
We welcome comments on these
proposals.
3. Payment of Radiopharmaceuticals in
the Physician Office
Section 303(c) of the Medicare
Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA) (Pub.
L. 108–173, enacted December 8, 2003)
revised the payment methodology for
most Medicare-covered Part B drugs by
adding section 1847A to the Act, which
established a new average sales price
(ASP) drug payment methodology for
separately payable Medicare Part B
drugs, beginning January 1, 2005.
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Specifically, section 303(h) of the MMA
states, ‘‘Nothing in the amendments
made by this section [303 of the MMA]
shall be construed as changing the
payment methodology under [Medicare]
Part B . . . for radiopharmaceuticals,
including the use by carriers of invoice
pricing methodology.’’
In accordance with the law,
radiopharmaceuticals are not required
to be paid using payment methodology
under section 1847A of the Act, as
currently described in the Medicare
Claims Processing Manual (MCPM)
Chapter 17, section 20.1.3. The manual
instructs MACs to determine payment
limits for radiopharmaceuticals based
on the methodology in place as of
November 2003, before the passage of
the MMA, in the case of
radiopharmaceuticals furnished in
settings other than the hospital
outpatient department. Currently,
payment can vary by MAC. For
example, payment can be based on 95
percent of Average Wholesale Price
(AWP), invoices, or other reasonable
payment methods/data made available
when the product is contractor
priced.261 262 263 264 265 266
CMS has heard from MACs and other
interested parties that there is confusion
about which exact methodologies are
available to MACs for pricing of
radiopharmaceuticals in the physician
office setting, as different MACs had
different methodologies in place as of
November 2003. MACs are uncertain
whether they can use any of these
payment policies that were in place, or
only the policy that was in place for
their jurisdiction as of November 2003.
Accordingly, while we evaluate our
broader policies in this space for future
rulemaking, we are proposing to clarify
261 How Does Palmetto GBA Price Drugs and
Biologics?, Palmetto GBA. https://
www.palmettogba.com/palmetto/jjb.nsf/DIDC/
8EELKH2211∼Specialties∼DrugsandBiologicals.
262 Radiopharmaceutical Fee Schedule 2024
Update, Noridian. https://
med.noridianmedicare.com/web/jeb/fees-news/feeschedules/radiopharmaceutical-fees.
263 Radiopharmaceutical Drugs—Billing
Instructions, A Celerian Group Company. https://
www.cgsmedicare.com/partb/pubs/news/2013/
0313/cope21543.html.
264 Reimbursement Guidelines for
Radiopharmaceuticals HCPCS Level II Codes,
Novitas Solutions. https://www.novitassolutions.com/webcenter/portal/MedicareJL/
pagebyid?contentId=00231502.
265 Reimbursement Guidelines for
Radiopharmaceuticals Procedure Codes (Prior to
January 2023), First Coast Service Options, Inc.
https://medicare.fcso.com/Coverage_News/
0494780.asp.
266 Radiopharmaceutical Reimbursement,
National Government Services. https://
www.ngsmedicare.com/web/ngs/fee-schedulelookup-details?lob=93617&state=97256&rgion=
93623&selectedArticleId=4920515.
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that any payment methodology that was
being used by any MAC prior to the
enactment of the MMA can continue to
be used by any MAC, including the use
of invoice pricing. That is, we are
proposing to clarify that any
methodology that was in place to set
pricing of radiopharmaceuticals in the
physician office setting prior to
November 2003 can be used by any
MAC, whether or not that specific MAC
used the methodology prior to
November 2003.
Thus, we are proposing to codify in
regulations at § 414.904(e)(6) that, for
radiopharmaceuticals furnished in a
setting other than the hospital
outpatient department, MACs shall
determine payment limits for
radiopharmaceuticals based on any
methodology used to determine
payment limits for
radiopharmaceuticals in place on or
prior to November 2003. Such
methodology may include, but is not
limited to, the use of invoice-based
pricing.
We welcome comments on these
proposals.
4. Immunosuppressive Therapy
(§§ 410.30 and 414.1001)
a. Background
Medicare Part B coverage of drugs
used in immunosuppressive therapy
was established by section 9335(c) of
the Omnibus Budget Reconciliation Act
of 1986 (Pub. L. 99–509) (OBRA ’86).
OBRA ’86 added subparagraph (J) to
section 1861(s)(2) of the Act to provide
Medicare Part B coverage for
immunosuppressive drugs, furnished to
an individual who receives an organ
transplant for which Medicare payment
is made, for a period not to exceed 1
year after the transplant procedure.
Coverage of these drugs under Medicare
Part B began January 1, 1987. Section
4075 of the Omnibus Budget
Reconciliation Act of 1987 (Pub. L. 100–
203) (OBRA ’87) revised section
1861(s)(2)(J) of the Act so that the scope
of coverage was expanded from
coverage of ‘‘immunosuppressive
drugs’’ to coverage of ‘‘prescription
drugs used in immunosuppressive
therapy.’’ For the purposes of this
proposed rule, we refer to this benefit as
the immunosuppressive drug benefit.
In the Medicare Coverage of
Prescription Drugs Used in
Immunosuppressive Therapy final rule
(60 FR 8951 through 8955), we finalized
policies for the scope of drugs for which
payment may be made under this
benefit. We finalized that payment may
be made for prescription drugs used in
immunosuppressive therapy that have
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been approved for marketing by the U.S.
Food and Drug Administration (FDA)
and meet one of the following
conditions:
(1) The approved labeling includes
the indication for preventing or treating
the rejection of a transplanted organ or
tissue.
(2) The approved labeling includes
the indication for use in conjunction
with immunosuppressive drugs to
prevent or treat rejection of a
transplanted organ or tissue.
(3) Have been determined by a Part B
carrier, in processing a Medicare claim,
to be reasonable and necessary for the
specific purpose of preventing or
treating the rejection of a patient’s
transplanted organ or tissue, or for use
in conjunction with
immunosuppressive drugs for the
purpose of preventing or treating the
rejection of a patient’s transplanted
organ or tissue. (In making these
determinations, the carriers may
consider factors such as authoritative
drug compendia, current medical
literature, recognized standards of
medical practice, and professional
medical publications.)
We also finalized the period of
coverage eligibility for a transplant
patient.267 Lastly, we established the
policy that drugs are covered under this
provision irrespective of whether they
can be self-administered. We codified
these policies at § 410.31 (later
redesignated as § 410.30).
We note that we do not maintain a list
of drugs covered under this benefit;
rather, MACs are expected to maintain
a list of these drugs, as stated in section
80.3, Chapter 17 of the Medicare Claims
Processing Manual. MACs are expected
to keep informed of FDA approvals of
immunosuppressive drugs and update
guidance as applicable.
While the eligibility timeframe has
been extended and eligibility has been
expanded since the immunosuppressive
drug benefit under Medicare Part B was
revised by OBRA ’87, the scope of drugs
267 Since the establishment of the benefit by the
enactment of OBRA ’86, the period of coverage for
a transplant patient under section 1861(s)(2)(J) of
the Social Security Act has been subsequently
amended by section 202 of the Medicare
Catastrophic Coverage Act of 1988 (Pub. L. 100–
360), the Medicare Catastrophic Coverage Repeal
Act of 1989 (Pub. L. 101–234), section 13565 of the
Omnibus Reconciliation Act of 1993 (OBRA ’93)
(Pub. L. 103–66), section 160 of the Social Security
Act Amendments of 1994 (Pub. L. 103–432), section
113 of the Medicare, Medicaid and SCHIP Benefits
Improvement and Protection Act of 2000 (Pub. L.
106–554) (BIPA 2000). The last of these statutory
changes eliminates the time limits for coverage of
prescription drugs used in immunosuppressive
therapy under the Medicare program, effective with
immunosuppressive drugs furnished on or after
December 21, 2000.
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payable under this benefit has not
changed. Some examples of how the
benefit has been extended and
expanded include: section 13565 of the
Omnibus Reconciliation Act of 1993
(OBRA ’93) (Pub. L. 103–66), amended
section 1861(s)(2)(J) of the Act to extend
the duration of coverage for the
immunosuppressive drug benefit to 36
months from the hospital discharge date
following a covered transplant
procedure for drugs furnished after CY
1997; section 113 of the Medicare,
Medicaid and SCHIP Benefits
Improvement and Protection Act of
2000 (Pub. L. 106–554) (BIPA) revised
section 1861(s)(2)(J) of the Act to
eliminate the time limits for coverage of
prescription drugs used in
immunosuppressive therapy under the
Medicare program; and most recently,
section 402 of the Consolidated
Appropriations Act, 2021 (Pub. L. 116–
260) amended section 226A(b)(2) to
allow certain individuals whose
Medicare entitlement based on ESRD
would otherwise end 36 months after a
kidney transplant to continue
enrollment under Medicare Part B only
for the coverage of immunosuppressive
drugs described in section 1861(s)(2)(J)
of the Act.
After reviewing our longstanding
policies for the immunosuppressive
drug benefit and engaging with
interested parties about current
practices and challenges, we are
proposing policies aimed to reduce
barriers faced by beneficiaries receiving
immunosuppressive drugs under this
benefit, as described below.
b. Compounded Immunosuppressive
Drugs With Oral or Enteral Routes of
Administration
As discussed in the previous section,
the immunosuppressive drug benefit
currently includes immunosuppressive
therapies that have been approved for
marketing by the FDA (and meet other
regulatory requirements at § 410.30).
Interested parties have expressed
concern that compounded formulations
of immunosuppressive drugs (for
example, a liquid formulation of an
immunosuppressive drug not
commercially available from a
manufacturer but prepared by a
pharmacist) are not included in the
immunosuppressive therapy benefit
because these formulations are not
approved by the FDA (that is, FDA does
not review these drugs to evaluate their
safety, effectiveness, or quality before
they reach patients),268 which is a
regulatory requirement under the
268 https://www.fda.gov/drugs/human-drugcompounding/compounding-laws-and-policies.
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current benefit. These interested parties
communicated that compounded
formulations are frequently used in the
treatment of transplant recipients who
cannot swallow oral capsules or tablets
due to age or oral-motor dysfunction.
Some examples of drugs compounded
for preventing or treating the rejection of
a transplanted organ or tissue include,
but are not limited to, azathioprine,269
cyclophosphamide,270 and
tacrolimus.271
We recognize certain patient groups,
such as those with dysphagia, those
with enteral feeding tubes (for example,
a nasogastric feeding tube or a
percutaneous endoscopic gastrostomy
(PEG) tube), and many pediatric
patients 272 273 covered under Medicare
rely on compounded
immunosuppressive drugs for
maintenance therapy and believe that
their inclusion in the
immunosuppressive drug benefit would
help to ensure that each beneficiary is
able to access the most clinically
appropriate formulation of an
immunosuppressive drug.274 275 276
Nonadherence to lifelong maintenance
immunosuppressive therapy contributes
to unfavorable post-transplant
outcomes, with obstacles to accessing
medication being a prominent risk
factor for such nonadherence.277
269 United States Pharmacopeia (2024). USP
Monographs, Azathioprine Compounded Oral
Suspension. USP–NF. Rockville, MD: United States
Pharmacopeia.
270 United States Pharmacopeia (2024). USP
Monographs, Cyclophosphamide Compounded Oral
Suspension. USP–NF. Rockville, MD: United States
Pharmacopeia.
271 United States Pharmacopeia (2024). USP
Monographs, Tacrolimus Compounded Oral
Suspension. USP–NF. Rockville, MD: United States
Pharmacopeia.
272 In the United States, children under 18 years
of age comprise only 0.14 percent of the total
Medicare ESRD population. Source: CY 2024 EndStage Renal Disease Prospective Payment System
final rule (88 FR 76374).
273 Lentine, K, Smith, JM, Lyden, GR, Miller, JM,
Dolan, TG, Bradbrook, K, Larkin, L, Temple, K,
Handarova, DK, Weiss, S, Israni, AK, Snyder, JJ
(2024). OPTN/SRTR 2022 Annual Data Report:
Kidney. American Journal of Transplantation,
24(2), S19–S118. https://doi.org/10.1016/
j.ajt.2024.01.012.
274 Silva RME, Portela RDP, da Costa IHF, et al.
Immunosuppressives and enteral feeding tubes: An
integrative review. J Clin Pharm Ther. 2020;45:408–
418. https://doi.org/10.1111/jcpt.13093.
275 Goorhuis JF, Scheenstra R, Peeters PM, Albers
MJ. Buccal vs. nasogastric tube administration of
tacrolimus after pediatric liver transplantation.
Pediatr Transplant. 2006 Feb;10(1):74–7. doi:
10.1111/j.1399–3046.2005.00402.x. PMID:
16499591.
276 Liverman, R, Chandran, MM, Crowther, B.
Considerations and controversies of pharmacologic
management of the pediatric kidney transplant
recipient. Pharmacotherapy. 2021 Jan;41(1): 77–102.
https://doi.org/10.1002/phar.2483.
277 Fine RN, Becker Y, De Geest S, et al.
Nonadherence consensus conference summary
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Therefore, we are proposing revisions at
§ 410.30 to include orally and enterally
administered compounded formulations
with active ingredients derived only
from FDA-approved drugs where
approved labeling includes an
indication for preventing or treating the
rejection of a transplanted organ or
tissue, or for use in conjunction with
immunosuppressive drugs to prevent or
treat rejection of a transplanted organ or
tissue, or have been determined by a
MAC, in processing a Medicare claim, to
be reasonable and necessary for this
specific purpose as outlined in the
immunosuppressive drug benefit. As we
intend this proposal to enhance access
and address adherence concerns for
patients who are not able to swallow
capsules or tablets and we do not
believe there are access concerns with
other types of formulations, we propose
to limit the included compounded
formulations to those products with oral
and enteral routes of administration (for
example, oral suspensions or solutions).
We solicit comment on these
proposals.
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c. Immunosuppressive Refill Policy and
Supplying Fee
Section 303(e)(2) of the MMA added
section 1842(o)(6) of the Act which
requires the Secretary to pay a
supplying fee (less applicable
deductible and coinsurance) to
pharmacies for certain Medicare Part B
drugs and biologicals, as determined
appropriate by the Secretary, including
for immunosuppressive drugs described
in section 1861(s)(2)(J) of the Act.
In the CY 2005 PFS, we established a
supplying fee of $50 for the initial oral
immunosuppressive prescription
supplied in the first month after a
transplant (69 FR 66312 through 66313).
In the CY 2006 Physician Fee Schedule,
we established a supplying fee of $16
for all subsequent prescriptions after the
initial prescription supplied during a
30-day period (70 FR 70233 through
70236).
Following the CY 2006 rulemaking,
we issued program instruction 278 to the
MACs that prohibits payment for refills
of immunosuppressive drug
prescriptions in most circumstances and
limits payment for prescriptions to 30day supplies. We state in Chapter 17 of
the Medicare Claims Processing Manual
that contractors should limit payment
for prescriptions to those of 30-day
supplies, except in special
circumstances, because dosage
report. Am J Transplant. 2009; 9(1): 35–41. doi:
10.1111/j.1600–6143.2008.02495.x.
278 Section 80.3, Chapter 17 of the Medicare
Claims Processing Manual.
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frequently diminishes over time; it is
not uncommon for the provider to
change the prescription from one drug
to another; and coinsurance liability on
unused drugs could be a financial
burden to the beneficiary.
We have heard from interested parties
that both the 30-day limit on supplies
and prohibition on payment for refills
no longer align with current practice for
treating patients on maintenance
immunosuppression regimens who are
prescribed a stable dosage for months or
years and receive refillable supplies for
several months’ use at a time. Frequent
dosage adjustments for some
immunosuppressive drugs that require
therapeutic drug monitoring and dose
titration based on blood concentrations,
such as tacrolimus, tend to occur more
often in newly transplanted recipients,
and less frequently once patients are on
stable regimens.279 Other
immunosuppressive drugs, such as
mycophenolate mofetil, do not require
routine therapeutic drug monitoring and
have fixed recommended dosages per
labeling where patients may be
maintained on stable dosages for several
months unless patients experience
complications.280 Transplant recipients
must take immunosuppressive drugs on
a lifelong basis to prevent rejection,
maintain allograft function, and, for
some transplanted organs, prevent
death. Most patients are eventually
prescribed stable maintenance
immunosuppressive drug dosages posttransplant for extended periods of time.
For example, liver transplant guidelines
recommend review of the
immunosuppressive drug regimen at
least every 6 months.281 For transplant
beneficiaries, we believe that the
limitation on payment to a maximum
30-day supply of immunosuppressive
therapy by our program instruction is an
unnecessary burden that poses a greater
risk to adherence than does the
potential for a sudden change in dosage
needs. There is considerable concern
among providers and advocates that
interrupted access to
immunosuppressive drugs caused by
running out of or having insufficient
279 Tacrolimus [package insert]. Northbrook, IL:
Astellas Pharma, Inc.; 2022. https://
www.accessdata.fda.gov/drugsatfda_docs/label/
2023/050708s055,010115s007lbl.pdf.
280 Cellcept [package insert]. San Francisco, CA:
Genentech USA, Inc.; 2022. https://
www.accessdata.fda.gov/drugsatfda_docs/label/
2022/050722s050,050723s050,050758s048,
050759s055lbl.pdf.
281 Lucey MR, Terrault N, Ojo L, et al. Long-term
management of the successful adult liver transplant:
2012 practice guideline by the American
Association for the Study of Liver Diseases and the
American Society of Transplantation. Liver Transpl.
2013 Jan;19(1):3–26. doi: 10.1002/lt.23566.
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medication supply can decrease
medication adherence, increase risk of
organ transplant rejection, and
ultimately decrease the rate of survival
of transplant recipients.282 283 We agree
with interested parties that it would be
beneficial to patients to reduce barriers
that complicate access to
immunosuppressive medication and
reasonable for CMS to make
programmatic changes consistent with
this objective.
Accordingly, we are proposing two
changes regarding supplying fees and
refills for immunosuppressive drugs.
First, we are proposing to allow
payment of a supplying fee for a
prescription of a supply of up to 90
days. To reflect this proposal, we are
proposing to revise § 414.1001 to allow
payment of a supplying fee to a
pharmacy for first prescriptions and for
prescriptions following the first
prescription for greater than a 30-day
supply. We are proposing additional
modifications at § 414.1001 to combine
paragraphs (a) (for supplying fees) and
(b) (for supplying fees following a
transplant). Accordingly, we are also
proposing to remove paragraph (b) and
redesignate paragraphs (c) and (d) as
paragraphs (b) and (c), respectively. We
intend to further study the supplying fee
schedule for immunosuppressive drugs
and are not proposing to make any
changes to the supplying fee amounts at
this time (meaning the current 30-day
supplying fees would apply to any
amount of days’ supply). The
dispensing and supplying fees under
Part B (§ 414.1001) have been shown to
be higher than dispensing fees paid in
the commercial market.284 So, until
additional study is done regarding input
costs for dispensing drugs billed to
Medicare Part B and subsequent noticeand-comment rulemaking can be done,
if appropriate, in response to such
information, we aim to continue the
current fee schedule regardless of the
days’ supply dispensed. Second, we are
proposing to allow payment of refills for
282 Nelson J, Alvey N, Bowman L, et al.
Consensus recommendations for use of
maintenance immunosuppression in solid organ
transplantation: Endorsed by the American College
of Clinical Pharmacy, American Society of
Transplantation, and the International Society for
Heart and Lung Transplantation. Pharmacotherapy.
2022; 42:599–633. doi: 10.1002/phar.2716.
283 Chisholm MA, Lance CE, Williamson GM,
Mulloy LL. Development and validation of an
immunosuppressant therapy adherence barrier
instrument. Nephrol Dial Transplant. 2005
Jan;20(1): 181–188. https://doi.org/10.1093/ndt/
gfh576.
284 https://www.pcmanet.org/rx-research-corner/
mandating-pharmacy-reimbursement-increasespending/08/31/2021/#:∼:text=The%20average
%20dispensing%20fee%20in,the%20state’s
%20Medicaid%20FFS%20rate.
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these immunosuppressive drugs. Under
our proposal, if finalized, the
prescribing healthcare provider may
adjust the days’ supply up to 90 days
and allow refills for an
immunosuppressive drug based on the
individual circumstance of the
beneficiary in accordance with
applicable state laws.
We welcome comments on these
proposals.
5. Blood Clotting Factors (§ 410.63)
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a. Background
Hemophilia is a genetic bleeding
disorder resulting in a deficiency of
coagulation Factor VIII (hemophilia A)
or coagulation Factor IX (hemophilia B)
due to mutations in the respective
clotting factor genes.285 286 Prophylactic
use of clotting factors has been proven
to improve quality of life by preventing
joint bleeds but requires maintenance
therapy, usually throughout the life of
the patient. Preventing joint damage
early is crucial because the initial
damage will progress, irrespective of
whether further bleeds occur in the
affected joints.287 Currently, clotting
factor treatments include: plasmaderived products, which are virally
inactivated and made from human
donor plasma; recombinant products,
such as recombinant Factors VIIa, VIII,
IX, X, XIII, which are created using
genetically engineered cells and
recombinant technology; and a
monoclonal antibody product that binds
to specific receptor sites of missing
clotting factor, which is needed for
effective hemostasis.288 289 Individuals
with hemophilia generally self-infuse
clotting factor at home, often learning to
do so in childhood.290 291 292
285 https://www.hemophilia.org/bleedingdisorders-a-z/types/hemophilia-a, accessed April 9,
2024.
286 https://www.hemophilia.org/bleedingdisorders-a-z/types/hemophilia-b, accessed April 9,
2024.
287 Aledort LM, Haschmeyer RH, Pettersson H. A
longitudinal study of orthopaedic outcomes for
severe factor-VIII-deficient haemophiliacs. The
Orthopaedic Outcome Study Group. J Intern Med.
1994 Oct;236(4):391–9.
288 Srivastava A, et al. Haemophilia.
2020;26(suppl 6):1–158.
289 https://dailymed.nlm.nih.gov/dailymed/
drugInfo.cfm?setid=2483adba-fab6-4d1b-96c5c195577ed071.
290 GAO–03–184 Medicare: Payment for Blood
Clotting Factor. www.gao.gov/assets/gao-03184.pdf.
291 Valentino, L.A., Baker, J.R., Butler, R., Escobar,
M., Frick, N., Karp, S., . . . Skinner, M. (2021).
Integrated Hemophilia Patient Care via a National
Network of Care Centers in the United States: A
Model for Rare Coagulation Disorders. Journal of
Blood Medicine, 12, 897–911. https://doi.org/
10.2147/JBM.S325031.
292 https://www.hemophilia.org/bleedingdisorders-a-z/treatment/current-treatments,
accessed April 9, 2024.
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Section 2324 of the Deficit Reduction
Act of 1984 (Pub. L. 98–369) added
subparagraph (I) to section 1861(s)(2) of
the Act to provide Medicare Part B
coverage of blood clotting factor
treatments for hemophilia patients who
are competent to use such factors to
control bleeding without medical
supervision (that is, self-administered),
and items related to the administration
of such factors; this is codified at
§ 410.63(b). As set forth in 1842(o)(1)(C)
of the Act, payment for clotting factor
product is the amount provided for
under section 1847A of the Act.
In January of 2003, the Comptroller
General of the United States published
a report entitled ‘‘Payment for Blood
Clotting Factor Exceeds Providers
Acquisition Cost’’ 293 (hereinafter
referred to the January 2003 report).
Among other things, the report found
that ‘‘providers incur additional costs
associated with delivering clotting
factor that are not separately reimbursed
by Medicare.’’ Specifically, the report
cited delivery costs generated in
inventory management, specialized
refrigerated storage, shipping, and the
provision of ancillary supplies such as
needles, syringes, and tourniquets to
patients that were not accounted for by
Medicare payment for the clotting factor
product alone.
After the release of the January 2003
report, section 303I(1) of the MMA
amended section 1842(o) of the Act by
adding a new paragraph (5), requiring
the Secretary to establish a furnishing
fee for the items and services associated
with the furnishing of blood clotting
factor. Specifically, section 1842(o)(5) of
the Act requires that for clotting factors
furnished on or after January 1, 2005,
the Secretary shall provide for a
separate payment to the entity which
furnishes blood clotting factors for items
and services related to the furnishing of
such factors in an amount that the
Secretary determines to be appropriate.
Accordingly, the clotting factor
furnishing fee was codified at
§ 410.63(c), which states that the
furnishing fee is added on a per unit
basis to the clotting factor.
In 2005, CMS established a furnishing
fee of $0.14 per unit of clotting factor.
The clotting factor furnishing fee is
increased by the percentage increase in
the Consumer Price Index (CPI) for
Medical Care for the 12-month period
ending with June of the previous year,
as required by Section 1842(o)(5)(C) of
the Act, and updated annually in
chapter 17, section 80.4.1 of the
Medicare Claims Processing Manual.
For 2024, the clotting factor furnishing
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fee is $0.250 per unit. Chapter 17 of the
Medicare Claims Processing Manual,
section 80.4.1 indicates that ‘‘CMS
includes this clotting factor furnishing
fee in the nationally published payment
limit for clotting factor billing codes’’
along with the pricing file, which
denotes which HCPCS codes have the
furnishing fee added. The payment limit
in the pricing file includes the payment
limit for the clotting factor product
(under methodology in section 1847A of
the Act) plus furnishing fee.
As was the case at the time the
clotting factor furnishing fee regulations
were originally finalized, we continue to
believe the products eligible for
payment of the clotting factor furnishing
fee and those eligible for payment as
clotting factor products are the same
subset of products: that is, selfadministered clotting factor products, as
described above. Similar to section
1861(s)(2)(I) of the Act, section
1842(o)(5) of the Act specifically
contemplates that clotting factors are
self-administered. In particular, section
1842(o)(5)(A)(ii) of the Act specifies that
the furnishing fee can take into account
‘‘ancillary supplies and patient training
for the self-administration of such
factors.’’ As stated in the CY 2005 PFS
final rule, the furnishing fee accounts
for the costs associated with supplying
the clotting factor, including patient
training necessary for selfadministration of such factors (69 FR
47523; 69 FR 66311). Thus, the clotting
factor furnishing fee, as implemented,
pays for services and supplies in
connection with the patient’s selfadministration of the product.
We note that section 1842(o)(5)(A) of
the Act directed the Secretary to
‘‘review [. . .] the January 2003 report’’
when establishing the separate payment
for entities which furnish blood clotting
factors to the patient. The January 2003
report refers to self-administration of
clotting factor and the benefits
beneficiaries receive from home-use of
the product throughout the report. For
example, the report states, ‘‘Individuals
with hemophilia generally self-infuse
clotting factor. Clotting factor can be
infused on demand, when a bleeding
episode occurs, or for prevention,
known as prophylactic use. By selfinfusing, individuals can avoid waiting
for care at a medical facility.’’
Most notably, for purposes of
understanding the Medicare clotting
factor payment inadequacy that was
addressed by Congress by adding the
furnishing fee, the report states ‘‘[t]he
method of delivery of clotting factor has
implications for Medicare payment.
Most outpatient drugs covered by
Medicare are administered in a
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physician’s office. When a beneficiary
visits a physician in order to receive a
drug, the physician receives one
payment from Medicare for the drug and
another payment through the physician
fee schedule for administering the drug.
Clotting factor, however, is generally not
administered in a physician’s office.’’
That is, the report highlighted that
Medicare payment for clotting factor, in
particular, was inadequate because there
are costs associated with supplying the
clotting factor, but because it is selfadministered, the furnishing of clotting
factor was generally not eligible for the
administration fee. Generally, the report
noted that payment for supplying other
outpatient drugs covered by Medicare
Part B were adequate because they are
eligible for the administration fee.
Again, as stated above, Congress
addressed this issue by creating the
furnishing fee for these selfadministered clotting factor products in
the MMA.
More recently, gene therapies have
been FDA-approved for the treatment of
hemophilia. These gene therapies
introduce a functional gene to the
patient, which provides the genetic
information needed for the patient to
produce the missing or nonfunctional
protein. A viral vector in the gene
therapies, engineered with adenoassociate virus, delivers the functional
copy of the clotting factor gene into the
patient’s liver cells. The viral vector
then releases the functional gene which
integrates into the cell’s DNA and starts
producing the missing clotting factor
protein (that is, Factor VIII or Factor IX)
to restore normal clotting function.
In the case of hemophilia A or B, the
gene therapy introduces the functional
gene that enables the patient to produce
Factor VIII or Factor IX, respectively, on
their own. Unlike clotting factors, which
promptly restore balance in the
coagulation cascade at the point of
deficiency or bridge activated Factor IX
and Factor X to restore the function of
missing activated Factor VIII,294
allowing for stable blood clot formation
and hemostasis, the gene therapies do
not directly integrate into the
coagulation cascade.295 296 In the
coagulation cascade, clotting factors
become activated in response to
damaged tissues or exposure to collagen
294 Genentech, Inc. Hemlibra (emicizumab-kxwh)
injection, for subcutaneous use. South San
Francisco, CA: Genentech, Inc.; 2023. Package
insert.
295 Hoffman, M., & Monroe, D.M. (2001). A cellbased model of hemostasis. Thrombosis and
Haemostasis, 85(6), 958–965.
296 Schenone M, Furie BC, Furie B. The blood
coagulation cascade. Curr Opin Hematol. 2004
Jul;11(4):272–7.
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at the injury site. This activation
initiates the conversion of prothrombin
to thrombin. Thrombin then converts
fibrinogen into fibrin strands, forming
the blood clot. Clotting factors restore
normal clotting function by replacing
deficient factors through repeated, doseadjustable infusions or injections. In
contrast, a single administration of gene
therapies maintains a consistent and
adequate level of clotting factors over
the long term by enabling the selfproduction of the clotting factor
proteins—an indirect method that relies
on the patient’s cells to increase clotting
factor levels. However, as the selfproduction of clotting factor proteins
takes time, the sustained outcomes of
gene therapies may take several weeks
to fully manifest. Interested parties have
asked if CMS considers these gene
therapies to be clotting factors for which
the clotting factor furnishing fee would
be paid.
Gene therapies for hemophilia are
administered via a one-time, single-dose
intravenous infusion in a setting where
personnel and equipment are
immediately available to treat infusionrelated reactions. They are not typically
administered by the patient in his or her
home, and close monitoring is required
for at least three hours after the end of
the infusion.297 While these gene
therapy products may have a similar
goal to clotting factor products, in that
both products are designed to improve
outcomes for patients with hemophilia,
gene therapy products prompt the body
to make clotting factors, but are not
clotting factors themselves. Given that
the administration would occur incident
to a physician service (that is, the
product is not self-administered), the
differing mechanism of action from
replacing deficient factors (that is,
triggering the body to make clotting
factors rather than infusing clotting
factors into the body), and the
requirement of close monitoring by a
healthcare professional post-infusion,
these gene therapies do not have the
characteristics described in the January
2003 report that is referenced in section
1842(o)(5) of the Act, which the
Secretary relied on in drafting
§ 410.63(c). Therefore, they do not
constitute ‘‘clotting factors’’ for
purposes of Medicare payment.
Accordingly, gene therapies for
hemophilia are eligible for payment as
drugs or biologicals under Part B as part
of (or incident to) a physician’s service.
The ‘‘incident to’’ coverage is limited to
297 Carvalho M, Sepodes B, Martins APPatient
access to gene therapy medicinal products: a
comprehensive reviewBMJ Innovations 2021;7:123–
134.
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61779
drugs that are not usually selfadministered and the physician
generally must incur a cost for the drug
and must bill for it. Furnishing entities
will bill for its administration, and the
administration fees will reflect the
resources necessary to furnish the drug.
For example, certain CPT codes for
administering drugs include preparation
of the dose and patient monitoring.
Specifically, CPT codes 96401–96549
(chemotherapy administration and
nonchemotherapy injections and
infusions) include clinical labor
activities such as clinical staff
preparation of chemotherapy agent(s) as
well as evaluation and management
services.298
For the reasons explained above, we
do not believe gene therapies for
hemophilia meet the definition of a
clotting factor for purposes of Medicare
payment, but even if they did, they still
would not be eligible for the furnishing
fee because the costs associated with
furnishing these gene therapies would
already be reflected in applicable
administration codes paid under the
Physician Fee Schedule. In accordance
with § 410.63(c)(1), a clotting factor
furnishing fee is not payable when the
costs associated with furnishing a
clotting factor are paid through another
payment system. In this case, the
payment system is the payment system
established under the Physician Fee
Schedule. Furnishing fees for drugs that
are physician administered would result
in physicians being paid twice for
incidental costs of administering the
drug because the furnishing fee is
intended to compensate for supplies
like needles, syringes, and tourniquets
as well as storage costs, and so is the
Part B payment for administering the
drug. We do not believe this double
payment is appropriate, nor do we
believe this is what Congress intended
in directing CMS to establish a clotting
factor furnishing fee.
Accordingly, in this proposed rule,
we are proposing to update § 410.63(b)
to clarify existing CMS policy that blood
clotting factors must be selfadministered to be considered clotting
factors for which the furnishing fee
applies. Additionally, we are proposing
to clarify at § 410.63(c) that the
furnishing fee is only available to
entities that furnish blood clotting
factors, unless the costs associated with
furnishing the clotting factor are paid
though another payment system,
including the Physician Fee Schedule.
That is, we are proposing to clarify
through revisions to § 410.63 that
298 Section 30.5, Chapter 12 of the Medicare
Claims Processing Manual.
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clotting factors (as specified in section
1861(s)(2)(I) of the Act) and those
eligible to receive the clotting factor
furnishing fee (as specified in section
1842(o)(5) of the Act) are the same
subset of products.
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B. Rural Health Clinics (RHCs) and
Federally Qualified Health Centers
(FQHCs)
1. Background on 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), licensed
marriage and family therapists, mental
health counselors, 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. 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
upper payment limits determined in
accordance with section 1833(f) of the
Act.
FQHCs were paid under the same AIR
methodology until October 1, 2014.
Beginning on that date, in accordance
with section 1834(o) of the Act (as
added by section 10501(i)(3) of the
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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 reduced by a productivity
adjustment. For CY 2025, CMS is
proposing to rebase and revise the
FQHC market basket to reflect a 2022
base year; see section III.B.7 of this
proposed rule.
2. 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, does not
always adequately describe the nonface-to-face care management work
involved in primary care and similar
care relationships. 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.
Before we get into the detailed
background of our RHC and FQHC
payment policies for care coordination
services, we want to acknowledge that
we have used several terms to describe
these services and are providing
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clarification. We use the terms ‘‘care
coordination’’ services interchangeably
with the term ‘‘care management’’
services in preamble and manual
guidance to describe the type of work
discussed above. We began to use the
term ‘‘general care management’’ when
we established the HCPCS code G0511
for CY 2018. Use of ‘‘general care
management’’ is meant to describe
certain non-face-to-face care
management work involved in primary
care that we have identified as
appropriate for separate payment as
discussed in the following paragraphs.
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 chronic care
management (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 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 through 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)
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services furnished in RHCs and FQHCs,
beginning on January 1, 2018. We also
initiated the use of HCPCS codes G0511
and G0512. HCPCS code G0511 is a
general care management code for use
by RHCs or FQHCs when at least 20
minutes of qualified CCM or general
BHI services are furnished to a patient
in a calendar month. HCPCS code
G0512 is for psychiatric CoCM and can
be billed by RHCs or FQHCs when at
least 60 minutes of qualified psychiatric
CoCM services are furnished to a patient
in a calendar month.
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).
In the CY 2019 PFS final rule (83 FR
59683), we 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. 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 noted that in the CY
2022 PFS final rule (86 FR 65118),
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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).
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.
Most recently, in the CY 2024 PFS
final rule (88 FR 79071 through 79073)
we included the CPT codes that are
associated with the suite of services that
comprise remote physiologic monitoring
(RPM) and remote therapeutic
monitoring (RTM) in the general care
management HCPCS code G0511 when
these services are furnished by RHCs
and FQHCs. In addition, we included
community heath integration (CHI),
principal illness navigation (PIN), and
PIN—peer support services in HCPCS
code G0511 when these services are
furnished by RHCs and FQHCs (88 FR
79073 through 79081). We noted that for
each of these newly included services
that they 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 also
clarified RHCs and FQHCs may bill
HCPCS code G0511 multiple times in a
calendar month, as long as all of the
requirements are met and resource costs
are not counted more than once (88 FR
79075).
Additional information on care
management requirements is available
on the CMS Care Management web page
and on the CMS RHC and FQHC web
pages.299 300 301
299 https://www.cms.gov/medicare/payment/feeschedules/physician/care-management.
300 https://www.cms.gov/center/provider-type/
rural-health-clinics-center.
301 https://www.cms.gov/medicare/payment/
prospective-payment-systems/federally-qualifiedhealth-centers-fqhc-center.
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61781
b. Proposed Regulatory Update
(§ 405.2464(c))
During our development of the
proposals discussed in section III.B.2.c.
and III.B.2.d. of this proposed rule, we
determined that the language located in
§ 405.2464(c) could use additional
information to streamline and provide
clarity on our payment policy for care
coordination services. For example,
using consistent terms, effective dates,
and the description of the basis of
payment. Therefore, we propose
technical changes to § 405.2464(c) to
accurately reflect the iterations of our
payment policy for care coordination
services as detailed in this background
section.
c. Proposed Payment Policy for General
Care Management Services
As discussed previously, in the last
few years of PFS payment rules we have
expanded the scope of care management
services billable using HCPCS code
G0511. Prior to CY 2024, HCPCS code
G0511 was based on the national
average non-facility PFS payment rate
for each base code identified as billable
general care management services. That
is, we added each payment rate divided
by the total number of codes to arrive
at the payment amount for HCPCS code
G0511. This payment amount was a flat
rate that was not subsequently adjusted
for locality.
In the CY 2024 PFS final rule (88 FR
79076 through 79079), we explained
continuing to calculate the value of
HCPCS code G0511 using an approach
based on an average 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 payment rate decreases.
We noted 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 finalized a revised
methodology for the calculation of
HCPCS code G0511 by looking at the
actual utilization of the services. We
used a weighted average of the services
that comprise HCPCS code G0511. For
the utilization data of the services, we
used the most recently available
utilization data from the services paid
under the PFS in the physician office
setting. We explained that the physician
office setting may provide 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
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furnished in RHCs and FQHCs since
they typically furnish primary care.
To ensure we accounted for payments
accurately, we explained that we looked
at PFS 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 comprising
general care management (that is, the
array of services that made up HCPCS
code G0511). We believed we needed 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.
Then to arrive at the payment rate for
HCPCS code G0511 for CY 2024, we
took 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.
We determined that this approach
was a more accurate representation of
the payment since it is consistent with
practitioners billing under the PFS, and
it accounts for the additional time spent
in care coordination.
Subsequent to the issuance of the CY
2024 PFS final rule, interested parties
have requested that CMS give them the
ability to bill Medicare for each of the
care management services that comprise
HCPCS code G0511 when they are
furnished in RHCs and FQHCs. RHCs,
FQHCs, and associations supporting
access to health care for rural
populations have expressed concerns
regarding the transparency of the
services being billed with HCPCS code
G0511. We note, in the CY2024 PFS
final rule we stated that HCPCS code
G0511 could be billed multiple times in
a calendar month for each care
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management code that comprised
HCPCS code G0511 as long as all
requirements were met, there was no
overlapping of resource time and
services were furnished in accordance
with CPT coding guidelines and
conventions. However, providing this
guidance triggered questions on how
CMS tracks which general care
management service is being furnished
if the bundled code is reported so they
would know when it was appropriate to
bill multiple care management services
on a single claim. RHCs and FQHCs
have also requested the ability to bill the
add-on codes that describe additional
minutes spent on furnishing care
management services and often ask for
guidance on how to account for
additional time spent.
We have also heard from interested
parties that RHCs and FQHCs would not
find it burdensome to report the actual
HCPCS code that describes the care
management service furnished, which
was the main concern we had when we
implemented HCPCS code G0511 (82 FR
53172). We understand that RHCs and
FQHCs have become more sophisticated
with billing and therefore reporting
multiple codes has become less
burdensome than in CY 2018 when we
implemented G0511. In addition, we
have heard that RHCs and FQHCs are
interested in having more exposure and
recognition in playing their part the
delivery of quality primary care and
believe that this could be achieved with
data that shows their utilization of
services which could also be used in
future payment refinements.
Due to these concerns, we have
reevaluated our payment policy for care
management services. We agree with
interested parties that it is important to
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identify the actual services being
furnished and understand the
utilization of these services, especially
given our strong interest in their volume
and their contribution to initiatives on
health equity and social needs of
services in the care coordination space.
Therefore, we are proposing to require
RHCs and FQHCs to bill the individual
codes that make up the general care
management HCPCS code, G0511. The
current list of base and add-on codes
that make-up G0511 are listed in Table
24, titled ‘‘General Care Management
HCPCS Codes and Descriptors.’’ Under
this proposal, HCPCS code G0511
would no longer be payable when billed
by RHCs and FQHCs. We note that the
payment amounts for some services that
made up G0511 are less than the
payment amount for G0511 and if an
RHC or FQHC mostly furnishes these
services, they could see a potential
decline in payment. We are also
proposing to allow RHCs and FQHCs to
bill the add-on codes for additional time
spent once the minimum threshold of
time was met to account for a complete
encounter. This could potentially offset
any decrease in payments. Payment for
these services would be the national
non-facility PFS payment rate when the
individual code is on an RHC or FQHC
claim, either alone or with other payable
services and the payment rates are
updated annually based on the PFS
amounts for these codes. We believe
that these proposals promote
transparency in billing and payment
and allowing RHCs and FQHCs to bill
the individual care management codes
would take into account the complexity
of the service and the time spent
furnishing the service.
BILLING CODE P
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61783
VerDate Sep<11>2014
99091
Collj & interpj data ea 30 d
99424
Prin care mgmt phys 1st 30
99425
Prin care mgmt phys ea addl
99426
Prin care mgmt staff 1st 30
99427
Prin care mgmt staff ea addl
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Frm 00189
Collection and interpretation of physiologic data (e.g. Blood
pressure, glucose monitoring) digitally stored and/or
transmitted by the patient and/or caregiver to the physician or
other qualified health professional, qualified by education,
training, licensure/regulation (when applicable) requiring a
minimum of30 minutes of time, each 30 da s
Principal care management services, for a single high-risk
disease, with the following required elements: one complex
chronic condition expected to last at least 3 months, and that
places the patient at significant risk ofhospitalization, acute
exacerbation/ decompensation, functional decline, or death, the
condition requires development, monitoring, or revision of
disease-specific care plan, the condition requires frequent
adjustments in the medication regimen, and/or the management
of the condition is unusually complex due to comorbidities,
ongoing communication and care coordination between
relevant practitioners furnishing care; first 30 minutes provided
personally by a physician or other qualified health care
ofessional er calendar month
Principal care management services, for a single high-risk
disease, with the following required elements: one complex
chronic condition expected to last at least 3 months, and that
places the patient at significant risk of hospitalization, acute
exacerbation/ decompensation, functional decline, or death, the
condition requires development, monitoring, or revision of
disease-specific care plan, the condition requires frequent
adjustments in the medication regimen and/or the management
of the condition is unusually complex due to comorbiditics,
ongoing communication and care coordination between
relevant practitioners furnishing care; each additional 30
minutes provided personally by a physician or other qualified
health care professional, per calendar month (l ,ist separately in
addition to code for rima
rocedure
Principal care management services, for a single high-risk
disease, with the following required elements: one complex
chronic condition expected to last at least 3 months, and that
places the patient at significant risk of hospitalization, acute
exacerbation/ decompensation, functional decline, or death, the
condition requires development, monitoring, or revision of
disease-specific care plan, the condition requires frequent
adjustments in the medication regimen and/or the management
of the condition is unusually complex due to comorbidities,
ongoing communication and care coordination between
relevant practitioners furnishing care; first 30 minutes of
clinical staff time directed by physician or other qualified
health care rofessional, er calendar month
Principal care management services, for a single high-risk
disease, with the following required elements: one complex
chronic condition expected to last at least 3 months, and that
places the patient at significant risk of hospitalization, acute
exacerbation/ decompensation, functional decline, or death, the
condition requires development, monitoring, or revision of
disease-specific care plan, the condition requires frequent
adjustments in the medication regimen and/or the management
of the condition is unusuall com lex due to comorbidities,
Fmt 4701
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TABLE 24: General Care Management HCPCS Codes and Descriptors
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99437
Chmc care mgmt phys ea addl
99439
Chmc care mgmt staf ca addl
99453
Rem mntr physiol param setup
99454
Rem mntr physiol param dev
99457
Rem physiol mntr 1st 20 min
99458
Rem physiol mntr ea addl 20
99474
Self-meas bp 2 readg bid 30d
99484
Care mgmt svc bhvl hlth cond
99487
Cplx chmc care 1st 60 min
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ongoing communication and care coordination between
relevant practitioners furnishing care; each additional 30
minutes of clinical staff time directed by a physician or other
qualified health care professional per calendar month (List
se aratel in addition to code for rim
rocedure
Chronic care management services, provided personally by a
physician or other qualified health care professional, with the
following required elements: multiple (two or more) chronic
conditions expected to last at least 12 months, or until the death
of the patient, chronic conditions place the patient at significant
risk of death, acute exacerbation/ decompensation, or
functional decline, comprehensive care plan established,
implemented, revised or monitored; each additional 30 minutes
by a physician or other qualified health care professional, per
calendar month (List separately in addition to code for primary
rocedure
Chronic care management services, each additional 20 minutes
of clinical staff time directed by a physician or other qualified
health care rofessional, er calendar month
Remote monitoring of physiologic parameter(s) (e.g. Weight,
blood pressure, pulse oximetry, respiratory flow rate) initial
set-u and atient education on use of e ui ment
Remote monitoring of physiologic parameter(s) (e.g. Weight,
blood pressure, pulse oximetry, respiratory flow rate) initial
device(s) supply with daily recording(s) or programmed alert(s)
transmission, each 30 da s
Remote physiologic monitoring treatment services, clinical
staff/physician/other qualified health care professional time in a
calendar month requiring interactive communication with the
atient/care iver durin the month; first 20 minutes
Remote physiologic monitoring treatment services, clinical
slaID'physician/other qualified health care professional lime in a
calendar month requiring interactive communication with the
patient/caregiver during the month; each additional 20 minutes
list se aratel in addition to code for rim
rocedure
Self:.measured blood pressure using a device validated for
clinical accuracy; separate self-measurementc; of two readings
one minute apart, twice daily over a 30-day period (minimum
of 12 readings), collection of data reported by the patient
and/or caregiver to the physician or other qualified health care
professional, with report of average systolic and diastolic
pressures and subsequent communication of a treatment plan to
the atient
Care management services for behavioral health conditions, at
least 20 minutes of clinical staff time, directed by a physician
or other qualified health care professional time, per calendar
month, with the following required element: initial assessment
or follow-up monitoring, including using applicable validated
rating scales, behavioral health care planning about behavioral
or psychiatric health problems, including revision for patients
not progressing or whose status changes, facilitating and
coordinating treatment such as psychotherapy,
phannacotherapy, counseling, or psychiatric consultation,
continuitv of care with an a ointed member of the care team
Complex chronic care management services, with the following
required elements: multiple (two or more) chronic conditions
ex cctcd to last at least 12 months, or until the death of the
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Cplx chrnc care ea addl 30
99490
Chrnc care mgmt staff 1st 20
99491
Chmc care mgmt phys 1st 30
98975
Rem ther mntr 1st setup&edu
98976
Rem ther mntr dev sply resp
98977
Rem ther mntr dv sply mscskl
98980
Rem ther mntr 1st 20 min
98981
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patient, chronic conditions place the patient at significant risk
of death, acute exacerbation/decompensation, or functional
decline, establishment or substantial revision of comprehensive
care plan, moderate or high complexity medical decision
making; first 60 minutes of clinical staff time directed by a
physician or other qualified health care professional, per
calendar month
Complex chronic care management services, with the following
required elements: multiple (two or more) chronic conditions
expected to last at least 12 months, or until the death of the
patient, chronic conditions place the patient at significant risk
of death, acute exacerbation/decompensation, or functional
decline, establishment or significant revision of comprehensive
care plan, moderate or high complexity medical decision
making; each additional 30 minutes of clinical staff time
directed by a physician or other qualified health care
professional, per calendar month (List separately in addition to
code for •
rocedure
Chronic care management services with the following required
elements: multiple (two or more) chronic conditions expected
to last at least 12 months, or until the death of the patient,
chronic conditions place the patient at significant risk of death,
acute exacerbation/decompensation, or functional decline,
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
Chronic care management services, provided personally by a
physician or other qualified healthcare professional, at least 30
minutes of physician or other qualified healthcare professional
time, per calendar month, with the following required elements:
multiple (two or more) chronic conditions expected to last at
least 12 months, or until the death of the patient, chronic
conditions place the patient at significant risk of death, acute
exacerbation/decompensation, or functional decline,
comprehensive care plan established, implemented, revised, or
monitored
Remote therapeutic monitoring (e.g. therapy adherence,
therapy response); initial set-up and patient education on use of
e ui ment
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 res irato s stem, each 30 da s
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 musculoskeletal svstem, each 30 da s
Remote therapeutic monitoring treatment management
services, physician or other qualified health care professional
time in a calendar month
requiring al least one interactive communication with the
atient or care •ver durin the calendar month; frrst 20 minutes
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 atient or care iver durin the
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G0140
Nav srv peer sup 60 min pr m
G0146
Nav srv peer sup add 30 pr m
G3002
Chronic pain mgmt 30 mins
G3003
Chronic pain mgmt add! 15m
G0323
Care manage heh svs 20mins
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calendar month; each additional 20 minutes (list separately in
addition to code for rima
rocedure
Principal Illness Navigation - Peer Support by certified or
trained auxiliary personnel under the direction of a physician or
other practitioner, including a certified peer specialist; 60
minutes er calendar month, for s ecified activities
Principal Illness Navigation-Peer Support, additional 30
minutes per calendar month (List separately in addition to
00140
Chronic pain management and treatment, monthly bundle
including, diagnosis; assessment and monitoring;
administration of a validated pain rating scale or tool; the
development, implementation, revision, and maintenance of a
person-centered care plan that includes strengths, goals, clinical
needs, and desired outcomes; overall treatment management;
facilitation and coordination of any necessary behavioral health
treatment; medication management; pain and health literacy
counseling; any necessary chronic pain related crisis care; and
ongoing communication and care coordination between
relevant practitioners furnishing care, e.g. physical therapy and
occupational therapy, and community-based care, as
appropriate. Required initial face-to- face visit at least 30
minutes provided by a physician or other qualified health
professional; first 30 minutes personally provided by physician
or other qualified health care professional, per calendar month.
(when usin G3002, 30 minutes must be met or exceeded
Each additional 15 minutes of chronic pain management and
treatment by a physician or other qualified health care
professional, per calenda month. (List separately in addition to
03002. When using G3003, 15 minutes mut be met or
exceeded.
Care management services for behavioral health conditions, at
least 20 minutes of clinical psychologist or clinical social
worker lime, per calendar month, with the following required
elements: initial assessment or follow-up monitoring, including
the use of applicable validated rating scales; behavioral health
care planning in relation to behavioral/psychiatric health
problems, including revision for patients who are not
progressing or whose status changes; facilitating and
coordinating treatment such as psychotherapy, coordination
with an/or referral to physicians and practitioners who arc
authorized by Medicare law to prescribe medications and
furnish E/M services counseling and/or psychiatric
consultation; and continuity of care with a designated member
of the care team
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 the ability to diagnose or treat problem(s)
addressed in an initiatin visit.
Community health integration services, each additional 30
minutes per calendar month (List separately in addition to
G0019
Principal Illness Navigation services by certified or trained
auxiliarv ersonnel under the direction of a h sician or other
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Pin srv add 30 min pr m
BILLING CODE C
We are proposing revisions at
§ 405.2464(c) to reflect the proposed
payment method for care management
services furnished in RHCs and FQHCs
beginning January 1, 2025. We welcome
comments on this proposed payment
methodology.
lotter on DSK11XQN23PROD with PROPOSALS2
d. New Codes for Advanced Primary
Care Management (APCM) Services
As discussed in section II.G of this
proposed rule, HHS and CMS have been
analyzing opportunities to strengthen
and invest in primary care in alignment
with the goals of the HHS Initiative to
Strengthen Primary Care.302 Research
has demonstrated that greater primary
care physician supply is associated with
improved population-level mortality
and reduced disparities,303 and also that
establishing a long-term relationship
with a primary care provider leads to
reduced emergency department (ED)
visits,304 improved care coordination,
and increased patient satisfaction.305
302 U.S. Department of Health and Human
Services. (2023). Primary Care: Our First Line of
Defense. https://www.hhs.gov/sites/default/files/
primary-care-issue-brief.pdf.
303 Basu S, Berkowitz SA, Phillips RL, Bitton A,
Landon BE, Phillips RS. Association of Primary
Care Physician Supply With Population Mortality
in the United States, 2005–2015. JAMA Intern Med.
2019;179(4):506–514. doi:10.1001/
jamainternmed.2018.7624. https://
jamanetwork.com/journals/jamainternalmedicine/
fullarticle/2724393.
304 Willemijn L.A. Schäfer et al, ‘‘Are People’s
Health Care Needs Better Met When Primary Care
Is Strong? A Synthesis of the Results of the
QUALICOPC Study in 34 Countries,’’ Primary
Health Care Research and Development 20 (2019):
e104. https://www.ncbi.nlm.nih.gov/pmc/articles/
PMC6609545/.
305 Michael J. van den Berg, Tessa van Loenen,
and Gert P Westert, ‘‘Accessible and Continuous
Primary Care May Help Reduce Rates of Emergency
Department Use: An International Survey in 34
Countries,’’ Family Practice 33, no. 1 (Feb. 2016):
42–50. https://academic.oup.com/fampra/article/
33/1/42/2450446.
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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 famil if a licable to a ro riate su ortive services.
Principal Illness Navigation services, additional 30 minutes per
calendar month List se aratel in addition to 00023 .
HHS recognizes that effective primary
care is essential for improving access to
healthcare, for the health and wellbeing
of individuals, families, and
communities, and for achieving health
equity. The first coordinated set of HHSwide actions to strengthen primary care,
as part of the Initiative, is in primary
care payment; for example, adjusting
payment to ensure it supports delivery
of advanced primary care. CMS
Innovation Center models, described in
section II.G.2.a.(1) of this proposed rule,
reflect the ongoing work within HHS
and the unified, comprehensive
approach to HHS primary care activities
that we are accomplishing through our
current statutory authorities and
funding.
In recent years, CMS has
implemented significant changes aimed
at better capturing the resources
required for care management services,
including chronic care management
(CCM), principal care management
(PCM), and transitional care
management (TCM) and more recently,
community health integration (CHI),
principal illness navigation (PIN) and
PIN-peer support services. For RHCs
and FQHCs, we have established
payment for these suites of care
management services outside of the
RHC AIR and FQHC PPS. The policy
requirements for RHCs and FQHCs
furnishing these various care
coordination services are consistent
with those finalized under the PFS.
In section II.G.2.b. of this proposed
rule, we are proposing to establish
coding and make payment under the
PFS for a newly defined set of APCM
services described and defined by three
new HCPCS G-codes. This new coding
would reflect the recognized
effectiveness and growing adoption of
the advanced primary care approach to
care. It would also encompass a broader
PO 00000
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range of services and simplify the
billing and documentation
requirements, as compared to existing
care management codes. The proposed
coding for APCM incorporates elements
of several existing care management
services into a bundle that we have
already considered to be care
coordination services paid separately to
RHCs and FQHCs using HCPCS code
G0511. For example, CCM and PCM. In
addition, the coding for APCM
incorporates elements of
communication technology-based
services (CTBS) into a bundle that we
have already considered to be virtual
communications paid separately to
RHCs and FQHCs using HCPCS code
G0071. For example, remote evaluation
of patient videos/images, virtual checkin, and e-visits. Therefore, to allow
RHCs and FQHCs the ability to simplify
the billing and documentation
requirements associated with furnishing
APCM services we are proposing to
allow RHCs and FQHCs to bill for these
services and receive separate payment.
Consistent with section II.G.2.b. of this
proposed rule, the APCM code sets vary
by the degree of complexity of patient
conditions (that is, non-complex and
complex CCM for multiple chronic
conditions or PCM for a single high-risk
condition), and whether the number of
minutes spent by clinical staff or the
physician or non-physician practitioner
(NPP) is used to meet time thresholds
for billing. The proposed HCPCS codes
are described below:
HCPCS code GPCM1 (Advanced
primary care management services
provided by clinical staff and directed
by a physician or other qualified health
care professional who is responsible for
all primary care and serves as the
continuing focal point for all needed
health care services, per calendar
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month, with the following elements, as
appropriate:
• Consent;
++ Inform the patient of the
availability of the service; that only one
practitioner can furnish and be paid for
the service during a calendar month; of
the right to stop the services at any time
(effective at the end of the calendar
month); and that cost sharing may
apply.
++ Document in patient’s medical
record that consent was obtained.
• Initiation during a qualifying visit
for new patients or patients not seen
within 3 years;
• Provide 24/7 access for urgent
needs to care team/practitioner,
including providing patients/caregivers
with a way to contact health care
professionals in the practice to discuss
urgent needs regardless of the time of
day or day of week;
• Continuity of care with a designated
member of the care team with whom the
patient is able to schedule successive
routine appointments;
• Deliver care in alternative ways to
traditional office visits to best meet the
patient’s needs, such as home visits
and/or expanded hours;
• Overall comprehensive care
management;
++ Systematic needs assessment
(medical and psychosocial).
++ System-based approaches to
ensure receipt of preventive services.
++ Medication reconciliation,
management and oversight of selfmanagement.
• Development, implementation,
revision, and maintenance of an
electronic patient-centered
comprehensive care plan;
++ Care plan is available timely
within and outside the billing practice
as appropriate to individuals involved
in the beneficiary’s care, can be
routinely accessed and updated by care
team/practitioner, and copy of care plan
to patient/caregiver;
• Coordination of care transitions
between and among health care
providers and settings, including
referrals to other clinicians and followup after an emergency department visit
and discharges from hospitals, skilled
nursing facilities or other health care
facilities as applicable;
++ Ensure timely exchange of
electronic health information with other
practitioners and providers to support
continuity of care.
++ Ensure timely follow-up
communication (direct contact,
telephone, electronic) with the patient
and/or caregiver after an emergency
department visit and discharges from
hospitals, skilled nursing facilities, or
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other health care facilities, within 7
calendar days of discharge, as clinically
indicated.
• Ongoing communication and
coordinating receipt of needed services
from practitioners, home- and
community-based service providers,
community-based social service
providers, hospitals, and skilled nursing
facilities (or other health care facilities),
and document communication
regarding the patient’s psychosocial
strengths and needs, functional deficits,
goals, preferences, and desired
outcomes, including cultural and
linguistic factors, in the patient’s
medical record;
• Enhanced opportunities for the
beneficiary and any caregiver to
communicate with the care team/
practitioner regarding the beneficiary’s
care through the use of asynchronous
non-face-to-face consultation methods
other than telephone, such as secure
messaging, email, internet, or patient
portal, and other communicationtechnology based services, including
remote evaluation of pre-recorded
patient information and
interprofessional telephone/internet/
EHR referral service(s), to maintain
ongoing communication with patients,
as appropriate;
++ Ensure access to patient-initiated
digital communications that require a
clinical decision, such as virtual checkins and digital online assessment and
management and E/M visits (or e-visits).
• Analyze patient population data to
identify gaps in care and offer
additional interventions, as appropriate;
• Risk stratify the practice population
based on defined diagnoses, claims, or
other electronic data to identify and
target services to patients;
• Be assessed through performance
measurement of primary care quality,
total cost of care, and meaningful use of
Certified EHR Technology.).
HCPCS code GPCM2 (Advanced
primary care management services for a
patient with multiple (two or more)
chronic conditions expected to last at
least 12 months, or until the death of
the patient, which place the patient at
significant risk of death, acute
exacerbation/decompensation, or
functional decline, provided by clinical
staff and directed by a physician or
other qualified health care professional
who is responsible for all primary care
and serves as the continuing focal point
for all needed health care services, per
calendar month, with the elements
included in GPCM1, as appropriate) and
HCPCS code GPCM3 (Advanced
primary care management services for a
patient that is a Qualified Medicare
Beneficiary with multiple (two or more)
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chronic conditions expected to last at
least 12 months, or until the death of
the patient, which place the patient at
significant risk of death, acute
exacerbation/decompensation, or
functional decline, provided by clinical
staff and directed by a physician or
other qualified health care professional
who is responsible for all primary care
and serves as the continuing focal point
for all needed health care services, per
calendar month, with the elements
included in GPCM1, as appropriate).
As we’ve established previously, care
coordination services are RHC/FQHC
services and as such, we are proposing
to align once again with the PFS and
adopt the new codes for APCM services.
Additionally, allowing separate
payment for APCM services in RHCs
and FQHCs is intended to reflect the
additional time and resources necessary
for the unique components of care
coordination services.
Further, in alignment with our
proposal earlier in this section to
require RHCs and FQHCs to utilize the
same coding as when billing under the
PFS and no longer use HCPCS code
G0511, which described many care
coordination services, we are proposing
to require RHCs and FQHCs when
furnishing APCM to use the codes
created for the PFS, that is, the three
HCPCS G-codes described above. We
would pay for these services in addition
to the RHC AIR or FQHC PPS because
we consider these services as non-faceto-face services and similar to other care
management services such as chronic
care management, principal care
management, and remote physiological
monitoring, where these services are not
captured in the RHC AIR or FQHC PPS
payment. Similarly, we are proposing
that payment for these services would
be paid at the PFS non-facility rate.
It is important to note that if RHCs
and FQHCs report these new codes, they
are per calendar month bundles. If the
RHC/FQHC decides to bill for APCM
then they would not bill for individual
services. For further discussion on
duplicative services and concurrent
billing restrictions with regard to APCM
policies, we refer readers to section
II.G.2.d. of this proposed rule.
e. Request for Information—Aligning
With Services Paid Under the PFS
As we discuss in section III.B.2.a. of
this proposed rule, over the last several
years we have been increasing our focus
on care coordination. These services
have evolved to focus on preventing and
managing chronic disease, improving a
beneficiary’s transition from the
hospital to the community setting, or on
integrative treatment of patients with
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behavioral health conditions. We have
acknowledged that the care
coordination included in services such
as office visits does not always describe
adequately the non-face-to-face care
management work involved and may
not reflect all the services and resources
required to furnish comprehensive,
coordinated care management for
certain categories of beneficiaries.
Therefore, under the PFS we have
proposed new services over the years
that practitioners billing under the PFS
can be paid separately under the PFS.
We have noted previously 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. Therefore,
we have proposed payment policies for
RHCs and FQHCs that complement the
new services for care coordination
under the PFS to align the RHC and
FQHC resource cost for those services
with payment.
The increase in frequency of this
complementary rulemaking has
triggered us to consider operational
efficiencies internally that we believe
could result in more transparency and
clarity for interested parties. Since RHCs
and FQHCs are generally paid under
encounter-based payment systems, we
have not systematically analyzed all
services paid under the PFS (nor do we
analyze all new services proposed) to
determine if they are included as a part
of the visit versus are eligible for
additional payment. Another reason that
we do not analyze every code is because
frequently codes created under the PFS
for billing practitioners are to more
appropriately account for resources paid
under the PFS. Codes for these purposes
are not applicable for RHCs and FQHCs
since they are not paid under the PFS.
Generally, for PFS services that are a
part of the office visit, there is no
separate payment under the RHC AIR or
FQHC PPS methodologies. On the
contrary, care coordination services
where the focus is on care management,
coordination, or certain activities
needed to manage chronic illnesses or
adapt to new models of care, we have
allowed separate payment for RHCs and
FQHCs.
We are seeking comment on how we
can improve the transparency and
predictability regarding which HCPCS
codes are considered care coordination
services. Our goal is to classify care
coordination services on the PFS in a
way that makes it automated in the
downstream effect on RHCs and FQHCs.
We believe establishing a streamlined
policy regarding which services are
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20:32 Jul 30, 2024
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separately paid for RHCs and FQHCs
versus included as part of the visit is
more transparent. In addition, a policy
where codes are communicated and
updated through sub-regulatory
guidance may be more efficient.
3. Telecommunication Services
a. Background
Section 3704 of the Coronavirus Aid,
Relief, and Economic Security Act (the
CARES Act) (Pub. L. 116–136, March
27, 2020) directed the Secretary to
establish Medicare payment for
telehealth services provided by RHCs
and FQHCs serving as a distant site (that
is, where the practitioner is located)
during the PHE for COVID–19.
Separately, section 3703 of the CARES
Act expanded CMS’ emergency waiver
authority to allow for a waiver of any of
the statutory telehealth payment
requirements under section 1834(m) of
the Act for telehealth services furnished
during the PHE. Specifically, section
1834(m)(8)(B) of the Act, as added by
the CARES Act, requires that the
Secretary develop and implement
payment methods for FQHCs and RHCs
that serve as a distant site during the
PHE for the COVID–19 pandemic. The
payment methodology outlined in the
CARES Act requires that rates shall be
based on rates that are similar to the
national average payment rates for
comparable telehealth services under
the Medicare PFS. CMS established
rates based on the average amount for
all PFS telehealth services on the
telehealth list, weighted by volume.
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
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61789
same way they currently do when these
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).
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 several
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.
Further, in the CY 2024 PFS final rule
(88 FR 79065), we discussed that the
CAA, 2023 (Pub. L. 117–328, December
29, 2022) further extended 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 amended 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. We noted
that payment continued to be made
under the methodology established for
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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 explained that section 4113(d) of
the CAA, 2023 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 stated that we will
continue to apply the delay of the inperson requirements under Medicare for
mental health services furnished by
RHCs and FQHCs. We noted that 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, 2023.306 Therefore, we revised the
regulations under §§ 405.2463 and
405.2469 again to reflect these
provisions (88 FR 79066 through
79067).
b. Direct Supervision Via Use of TwoWay Audio/Video Communications
Technology
Under Medicare Part B, certain types
of services are required to be furnished
under specific minimum levels of
supervision by a physician or
practitioner. See section II.D.2.a. for the
discussion regarding direct supervision
for services provided using
telecommunications technologies under
the PFS.
In the CY 2024 PFS final rule (88 FR
79067), we explained that extending
this definition of direct supervision for
RHCs and FQHCs under our regulations
at §§ 405.2413, 405.2415, 405.2448, and
405.2452 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. In addition, we were
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 believed that RHCs and FQHCs
would need time to reorganize their
practices established during the PHE to
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reimplement the pre-PHE approach to
direct supervision without the use of
audio/video technology. Similar to
services furnished in physician office
setting, RHC and FQHC 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 coordination services which
may be furnished under general
supervision. For CY 2024, we continued
to define ‘‘immediate availability’’ as
including real-time audio and visual
interactive telecommunications through
December 31, 2024, and solicited
comment on whether we should
consider extending the definition of
‘‘direct supervision’’ to permit virtual
presence beyond December 31, 2024.
(1) Proposal for CY 2025
In the CY 2024 PFS proposed rule, we
solicited comment 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 were also interested in
potential program integrity concerns
such as overutilization or fraud and
abuse that interested parties may have
in regard to this policy.
Comments provided were overall
supportive of our proposal to continue
to define ‘‘immediate availability’’ to
include availability through virtual
means, stating that it will benefit
healthcare providers while greatly
enhancing patient access to quality care,
particularly in underserved areas.
Commenters also noted that direct
supervision has become increasingly
challenging and the option to provide
virtual direct supervision has enhanced
the quality and provision of healthcare
services beneficiaries have received in
medically underserved, rural
communities.
We note that in section II.D.2.a. of this
proposed rule, there is a proposal to
permanently adopt a definition of direct
supervision that allows ‘‘immediate
availability’’ of the supervising
practitioner using audio/video real-time
communications technology (excluding
audio-only), but only for the following
subset of incident-to services described
under § 410.26, (1) services furnished
incident to a physician or other
practitioner’s service when provided by
auxiliary personnel employed by the
billing practitioner and working under
their direct supervision, and for which
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the underlying HCPCS code has been
assigned a Professional Component/
Technical Component indicator of ‘5’;
and (2) services described 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). In addition, under the
PFS we are proposing for all other
services required to be furnished under
the direct supervision of the supervising
physician or other practitioner, to
continue to define ‘‘immediate
availability’’ to include real-time audio
and visual interactive
telecommunications technology only
through December 31, 2025.
After evaluating the information
gathered through the comment
solicitation, we believe that we should
maintain the current flexibility in RHCs
and FQHCs as it continues to support
access and preserve workforce capacity.
We believe that there is value in
allowing RHC and FQHC services to be
furnished under direct supervision
where virtual presence meets the
definition of ‘‘immediately available’’ as
status quo, so that we may further
evaluate the services along with the
analysis occurring for the remaining
services that we are contemplating
under the PFS. We note that there may
be nuances in the RHC and FQHC
settings since generally payment is at
the AIR or PPS rate and not at the
individual service code level to carve
out services limited/obvious services
from other services. We could seek to
establish a final policy in RHCs and
FQHCs once a final policy is determined
under the PFS, to avoid confusion since
they are taking an incremental approach
at the code level for CY 2025.
Therefore, we are proposing to
maintain the virtual presence flexibility
on a temporary basis, that is, the
presence of the physician (or other
practitioner) would include virtual
presence through audio/video real-time
communications technology (excluding
audio-only) through December 31, 2025.
c. Telecommunications Technology
As discussed above, section 3704 of
the Coronavirus Aid, Relief, and
Economic Security Act (the CARES Act)
(Pub. L. 116–136, March 27, 2020)
directed the Secretary to establish
Medicare payment for telehealth
services provided by RHCs and FQHCs
serving as a distant site (that is, where
the practitioner is located) during the
PHE for COVID–19. Separately, section
3703 of the CARES Act expanded CMS’
emergency waiver authority to allow for
a waiver of any of the statutory
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telehealth payment requirements under
section 1834(m) of the Act for telehealth
services furnished during the PHE.
Specifically, section 1834(m)(8)(B) of
the Act, as added by the CARES Act,
required that the Secretary develop and
implement payment methods for FQHCs
and RHCs that serve as a distant site
during the PHE for the COVID–19
pandemic. The payment methodology
outlined in the CARES Act requires that
rates shall be based on rates that are
similar to the national average payment
rates for comparable telehealth services
under the Medicare PFS. Therefore,
CMS established rates based on the
average amount for all PFS telehealth
services on the telehealth list, weighted
by volume. RHCs and FQHCs bill for
these Medicare telehealth services using
HCPCS code G2025.
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
services are furnished in-person.
The temporary authority under
section 1834(m)(8) of the Act was
extended by statute through the end of
CY 2024, meaning under current law,
and absent additional changes in
regulation, RHCs and FQHCs could not
be paid for non-behavioral health
services furnished remotely to
beneficiaries enrolled in fee-for-service
Medicare after December 31, 2024.
(1) Payment Proposal for NonBehavioral Health Telecommunication
Technology Services
Widespread use of
telecommunications technology to
furnish services during the PHE has
illustrated interest within the medical
community and among Medicare
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beneficiaries in furnishing and receiving
care through the use of technology
beyond the PHE. During the PHE, RHCs
and FQHCs, much like other provider
types, have had to change how they
furnish care in order to meet the needs
of their patients, and use of the
temporary authority to bill Medicare for
PFS telehealth services has been widely
utilized by RHCs and FQHCs during the
PHE. Eliminating flexibilities under
which RHC and FQHC services have
been furnished to beneficiaries via
telecommunication technologies for
over four years and resuming solely inperson, face-to-face medical visits after
December 31, 2024, would cause
disruptions in access to services from
RHC and FQHC practitioners. This
would be particularly problematic for
the underserved populations that these
settings furnish services to since it
could fragment care. We believe that we
need to preserve the flexibilities under
which RHC and FQHC services have
been furnished to beneficiaries via
telecommunication technologies
temporarily and to do so through an
approach that these settings are familiar
with in order to mitigate burden.
Technologies used in this space and the
quality of care associated with them
continue to evolve. We believe that it
would be prudent to allow time to
engage interested parties while we
consider how to incorporate
telecommunication technology services
on a more permanent basis.
For these reasons, we propose, on a
temporary basis, to allow payment for
non-behavioral health visits furnished
via telecommunication technology. We
propose to facilitate payments using an
approach that closely aligns with the
mechanisms mandated by the statute
but ends December 31, 2024. That is,
RHCs and FQHCs would continue to bill
for RHC and FQHC services furnished
using telecommunication technologies
by reporting HCPCS code G2025 on the
claim, including services furnished
using audio-only communications
technology. Since the costs associated
with non-behavioral health visits
furnished via telecommunication
technology are not included in the
calculations for the RHC AIR
methodology and FQHC PPS, we believe
that we need to propose a proxy that
would represent such resources used
when furnishing these services.
Therefore, we propose to continue to
calculate the payment amount based on
the average amount for all PFS
telehealth services on the telehealth list,
weighted by volume for those services
reported under the PFS. We believe that
using this weighted average is
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appropriate during this interim while
we contemplate permanent policies for
these services since there is a wide
range of values for the telehealth
services under the PFS. We believe that
RHCs and FQHCs generally furnish
services that are similar to and at a
frequency the same as physicians and
other practitioners paid under the PFS.
While we do not have actual cost
information, we believe that this
weighted average is an appropriate
proxy since it addresses certain resource
costs experienced by professionals and
would mitigate any potential over or
under payments. Costs associated with
these services would continue to not be
used in determining payments under
the RHC AIR methodology or the FQHC
PPS.
We believe that these proposals
would preserve the telecommunication
technology flexibility under which RHC
and FQHC services have been furnished
for over 4 years and would not impact
access to care for Medicare beneficiaries
who currently benefit from these
services while CMS contemplates next
steps. We solicit comment on whether
there may be other payment
methodologies that may be a proxy for
costs associated with non-behavioral
health visits furnished via
telecommunication technology and why
those payment methodology may be
more appropriate than the weighted
average of the telehealth services list
under PFS.
We propose to amend § 405.2464 by
adding new paragraph (g) to reflect our
proposed payment policy for nonbehavioral health services furnished in
RHCs and FQHCs via
telecommunication technology for CY
2025.
(2) Alternative Proposal Considered for
Payment of Medical Visits Furnished
Via Telecommunication Technology
We considered reevaluating the
regulations regarding face-to-face visit
requirements for encounters between a
beneficiary and an RHC or FQHC
practitioner in light of contemporary
medical practices. That is, we
considered proposing a revision to the
regulatory requirement that an RHC or
FQHC medical visit must be a face-toface (that is, in-person) encounter
between a beneficiary and an RHC or
FQHC practitioner to also include
encounters furnished through
interactive, real-time, audio and video
telecommunications technology. This
would result in payment for services
furnished via telecommunication
technology to be made under the RHC
AIR methodology and under the FQHC
PPS, similar to how we revised the
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regulations for mental health visits. We
believe interested parties may prefer the
per visit payment that aligns with the
RHC AIR or FQHC PPS. However, we
did not propose this alternative because
we determined that it would have
unintended consequences, especially in
cases where the RHC AIR or FQHC PPS
per-visit rates would be significantly
higher than the PFS rate that would
apply if other entities furnished the
same service to the same beneficiary in
the same location.
We believe that continuing to pay
temporarily for RHC and FQHC services
furnished via telecommunication
technologies in the same manner as we
have done over the past several years
preserves the flexibility for RHCs and
FQHCs to continue access to care,
mitigates administrative burden, and
mitigates potential program integrity
concerns. However, we solicit comment
on the alternative proposal we
considered. That is, revising the
definition of a visit to include
interactive, real-time, audio/video
telecommunication technology which
would result in a capitated payment
under the RHC AIR methodology or
FQHC PPS.
d. In-Person Visit Requirements for
Remote Mental Health Services
Furnished by RHC and FQHCs
The CAA, 2021, stipulated that the
beneficiary needed to receive an in
person, non-telehealth service 6 months
prior to initiation of the telehealth
mental health services and that the
Secretary should determine an
appropriate frequency for provision of
subsequent periodic in person, nontelehealth services.
In the CY 2022 PFS final rule with
comment (86 FR 65210), 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.
As discussed in the CY 2023 PFS final
rule (87 FR 69738), the CAA, 2022
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included the extension of a number of
Medicare telehealth flexibilities
established during the PHE for COVID–
19 for a limited 151-day period
beginning on the first day after the end
of the PHE. Division P, Title III, section
304 of the CAA, 2022, delayed the inperson 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.
The CAA, 2023 (Pub. L. 117–328,
December 29, 2022) extended 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 ended prior to that
date. While the CAA, 2021 only applied
to the PFS, we implemented similar
policies for RHCs, FQHCs, and hospital
outpatient departments. The in-person
visit requirements are currently set to
take effect for services furnished on or
after January 1, 2025.
However, given concerns from
interested parties on the impact of
enforcing these requirements after
multiple years of delay, we are
proposing an additional extension. We
are proposing to continue to delay the
in-person visit requirement for mental
health services furnished via
communication technology by RHCs
and FQHCs to beneficiaries in their
homes until January 1, 2026.
4. Intensive Outpatient Program
Services (IOP)
a. Background
As we discussed in the CY 2024 OPPS
final rule (88 FR 81838) section 4124 of
Division FF of the CAA, 2023
established Medicare coverage for
intensive outpatient program (IOP)
services furnished by a hospital to its
outpatients, or by a community mental
health center (CMHC), a FQHC or a
RHC, as a distinct and organized
intensive ambulatory treatment service
offering less than 24-hour daily care in
a location other than an individual’s
home or inpatient or residential setting,
effective January 1, 2024.
IOP is a distinct and organized
outpatient program of psychiatric
services provided for individuals who
have an acute mental illness, which
includes, but is not limited to
conditions such as depression,
schizophrenia, and substance use
disorders. We noted an IOP is thought
to be less intensive than a partial
hospitalization program (PHP).
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This new provision mandated several
areas of policy to implement an IOP
program, including scope of benefits
and services, certification and plan of
care requirements, and special payment
rules for IOP services in RHCs and
FQHCs, all of which are discussed in
the CY2024 OPPS final rule (88 FR
81838 through 81845). We made
corresponding regulation changes for
IOP services at §§ 405.2400, 405.2401,
405.2410, 405.2411, 405.2446, 405.2462,
405.2463, 405.2464, 405.2468, and
405.2469.
b. Update to Special Payment Rules for
Intensive Outpatient Services
As we discussed in the CY 2024 OPPS
final rule (88 FR 81841), section 4124(c)
of the CAA, 2023 further amended
section 1834(o) of the Act and section
1834(y) of the Act, to provide special
payment rules for both FQHCs and
RHCs, respectively, for furnishing IOP
services. Section 4124(c)(1) of the CAA,
2023 amended section 1834(o) of the
Act to add a new paragraph (5)(A) to
require that payment for IOP services
furnished by FQHCs be equal to the
amount that would have been paid
under Medicare for IOP services had
they been covered outpatient
department services furnished by a
hospital. In addition, section 4124(c)(2)
of the CAA, 2023 amended section
1834(y) of the Act to add a new
paragraph (3)(A) to require that payment
for IOP services furnished by RHCs be
equal to the amount that would have
been paid under Medicare for IOP
services had they been covered
outpatient department services
furnished by a hospital.
In the CY 2024 OPPS final rule (88 FR
81841), we provided a detailed
discussion of the final CY 2024 payment
rate methodology for IOP. CMS finalized
two payment rates, a 3- and a 4- or more
services per day, for IOP services for
hospitals and CMHCs. However, for
RHCs and FQHCs we established a 3service per day payment rate. We stated
that we believed it was appropriate to
establish the payment rate where the
utilization is typically structured to be
days with 3 or fewer services and
solicited comment on whether the
hospital-based IOP payment rate for 4service days would be appropriate for
RHCs and FQHCs. Although we
previously stated that we would review
the data and consider a 4 or more
services per day for future rulemaking,
we have since considered this further.
We believe that we should provide
parity for IOP services across the
various settings with site neutral
payments while continuing to monitor
access to these services. Therefore, we
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are proposing to provide a payment rate
for 4 or more services per day in an
RHC/FQHC setting. Additionally, as
required in section 4124(c)(2) of the
CAA, 2023 we would align with the 4
or more-services per day payment rate
for hospital outpatient departments. As
with the 3-services per day, the 4 or
more services per day payment rates
will be updated annually.
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c. Technical Correction (§§ 405.2410
and 405.2462)
In the CY 2024 Hospital Outpatient
Prospective Payment (OPPS) and
Ambulatory Surgical Center (ASC)
Payment Systems final rule with
comment (88 FR 81844) we finalized
revisions to §§ 405.2410, 405.2462, and
405.2464 in the regulations to reflect the
payment amount for IOP services and
how the Medicare Part B deductible and
coinsurance are applied in RHC’s and
FQHC’s. For RHCs, the beneficiary is
responsible for the Medicare Part B
deductible and coinsurance amounts at
an amount not to exceed 20 percent of
the clinic’s reasonable charges for IOP
services. For FQHC’s, the beneficiary is
responsible for a coinsurance amount of
20 percent of the lesser of the FQHC’s
actual charge for the service or the IOP
rate. We revised the regulatory
requirements at § 405.2410, Application
of Part B deductible and coinsurance
and § 405.2462, Application of
deductible and coinsurance for RHCs
and FQHCs paid on the basis of the
special payment rule under
§ 405.2462(j) to reflect how the
Medicare Part B deductible and
coinsurance are applied.
During a recent review of our
regulations at §§ 405.2410(c) and
405.2462(j), we noticed that both
sections had errors. That is,
§ 405.2410(c) does not reflect the correct
policy that is applicable for beneficiary
coinsurance when they receive IOP
services in RHCs and FQHCs. With
regard to the error at § 405.2462(j), we
inadvertently left language specific to
RHCs in the introductory text when it
should have been its own paragraph.
Therefore, we propose revisions to
§ 405.2410 to reflect the correct policy
applicable for beneficiary coinsurance
as described above in the previous
paragraph. We also propose revisions to
§ 405.2462(j) to accommodate the new
paragraph (j)(1).
5. Payment for Preventive Vaccine Costs
in RHCs and FQHCs
a. Background
Section 1833(a)(3)(A) of the Act
specifies that services described in
section 1861(s)(10)(A)—pneumococcal,
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influenza and COVID–19 vaccines and
their administration—are exempt from
the RHC and FQHC payment limit of 80
percent of reasonable costs. Therefore,
payment for pneumococcal, influenza
and COVID–19 vaccines and their
administration in RHCs and FQHCs is
governed by the statute at Section
1833(b) of the Act, which requires
payment at 100 percent of reasonable
cost. For RHCs, this means that costs
associated with these vaccines and their
administration are not included in
determining the AIR or subject to the
payment limit, and for FQHCs, these
costs are not included under the FQHC
PPS. We note that the hepatitis B
vaccine, which is described at section
1861(s)(10)(B) of the Act, is not
specified at 1833(a)(3)(A) as exempt
from the RHC/FQHC payment limit of
80 percent of reasonable costs, and
therefore, payment for a hepatitis B
vaccine and its administration is
included in the FQHCs PPS rate and the
RHC AIR. However, since hepatitis B
vaccines and their administration are
considered a Part B preventive service,
no coinsurance or deductible is charged
when a hepatitis B vaccine is
administered in an RHC or FQHC.
Please see section III.H.2.c. of this
proposed rule for more information on
hepatitis B vaccines in RHCs and
FQHCs.
In the April 3, 1996 FQHC final rule
(61 FR 14657), we codified at
§ 405.2466(b)(1)(iv) that, for RHCs and
FQHCs, payment for pneumococcal and
influenza vaccine and their
administration is 100 percent of
Medicare reasonable cost, which is paid
as part of the annual reconciliation
through the cost report. In the CY 2022
PFS final rule (86 FR 65207), we made
conforming changes in that section to
include the COVID–19 vaccine and its
administration.
b. Revisions to Current Policy
In the May 2, 2014 RHC/FQHC PPS
final rule (79 FR 25449), we addressed
commenters’ recommendations that
CMS apply a consistent approach to
payment for Part B vaccines. One
commenter specifically recommended
that CMS allow RHCs and FQHCs to bill
for Part B vaccines at the time of service,
either with or without an encounter for
a visit. The commenter stated that those
bills could be paid using national Part
B rates, to be followed by an annual
reconciliation on the cost report
between the payments and the
reasonable costs of the vaccines and
their administration. This commenter
wished to reduce the time between
vaccine administration and payment,
and to enable the documentation on
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61793
individual patient claims that these
vaccines were furnished. Commenters
generally asserted that streamlining Part
B vaccine payment would help ensure
broad vaccine access for Medicare
beneficiaries.
In response to these comments, we
responded that we did not believe that
any changes in our billing policies were
necessary. We stated that RHCs and
FQHCs are accustomed to reporting and
receiving payment for the reasonable
costs of Part B vaccines and their
administration through the annual cost
report, and we believed that an annual
reconciliation between vaccine
payments and reasonable costs would
create an additional administrative
burden for FQHCs and MACs. We also
noted that as of January 1, 2011, FQHCs
have been required to report
pneumococcal and influenza vaccines
and their administration on a patient
claim with the appropriate HCPCS and
revenue codes when furnished during a
billable visit. Please note that this is not
a requirement for RHCs.
In the CY 2022 PFS final rule (86 FR
65207), in which we made conforming
regulatory changes at
§ 405.2466(b)(1)(iv) to include the
COVID–19 vaccine, we received several
comments regarding the timing of
vaccine payments for RHCs and FQHCs.
These comments echoed the sentiments
expressed by the commenters on the
same topic in the 2014 final rule
mentioned above, and while they were
out of the scope of our proposals for
CY2022, we will elaborate on them here.
These commenters expressed
appreciation for measures taken by CMS
in April 2021 to make lump-sum
payments for COVID–19 vaccine
administration available to RHCs and
FQHCs in advance of cost report
settlement, but commenters emphasized
that those payments were only a
temporary solution. Commenters urged
CMS to update the RHC and FQHC cost
report to ensure adequate, permanent
reimbursement for COVID–19 vaccines.
Commenters added that RHCs and
FQHCs have experienced challenges
with burdensome reporting
requirements and data collection, as
well as slow distribution of payments
from MACs. Another commenter stated
that RHCs and FQHCs should not have
to wait until settlement of cost report to
be reimbursed for other preventive
vaccines, and that delayed payment may
hinder them from immunizing Medicare
beneficiaries.
While we did not respond directly to
those comments in the CY 2022 PFS
final rule, as they were out of scope of
the policies that were finalized at the
time, we did make clarifications
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regarding payment for preventive
vaccines and their administration in the
RHC and FQHC Frequently Asked
Questions (FAQs) that accompanied the
publication of the CY 2022 PFS final
rule.307 In those FAQs, we clarified that
the conforming change made to
§ 405.2466(b)(1)(iv) to reflect coverage
and payment for COVID–19 vaccines in
RHCs and FQHCs did not reflect any
other payment policy changes regarding
payment for Part B vaccines and
administration in those settings. We
reiterated that RHCs and FQHCs are
paid 100 percent of reasonable cost
through their cost report for Part B
vaccines and their administration. Since
there is a gap in time from when costs
are incurred in RHCs and FQHCs for
furnishing vaccines and when payment
is received, the Medicare
Administrative Contractors (MACs)
could provide early payments in the
form of lump sum payments to RHCs
and FQHCs in March of 2021 to
facilitate COVID–19 vaccinations. RHCs
and FQHCs can request additional lump
sum payments from their MAC at any
time.
Since the publication of the CY 2022
PFS final rule, we have given additional
consideration to the comments
discussed above. During and since the
COVID–19 PHE, CMS has especially
promoted efforts aimed at facilitating
increased access to vaccinations for both
Medicare enrollees and all Americans.
Vaccination promotion efforts also
dovetail with CMS’ overarching
strategic priorities of expanding health
care access and advancing health equity.
For CY 2025, CMS has identified the
issue of vaccination in RHCs and
FQHCs as an area where payment policy
can be updated to improve access to
preventive vaccines for Medicare
enrollees.
We are proposing to allow RHCs and
FQHCs to bill for the administration of
Part B preventive vaccines at the time of
service. Based on the proposed changes
in section III.M. and III.H.2.c. of this
proposed rule, this revision in policy
would include all four Part B preventive
vaccines: pneumococcal, influenza,
hepatitis B, and COVID–19 vaccines.
These claims would initially be paid
like other Part B vaccine and vaccine
administration claims, whose payments
are discussed at section III.H.1. of this
proposed rule: vaccine products would
be paid at 95 percent of their Average
Wholesale Price (AWP), and vaccine
administration would be paid according
307 RHCs CY 2022 PFS Final Rule Fact Sheet:
https://www.cms.gov/files/document/rhcs-pfsfaqs.pdf; FQHCs CY 2022 PFS Final Rule Fact
Sheet: https://www.cms.gov/files/document/fqhcspfs-faqs.pdf.
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to the National Fee Schedule for
Medicare Part B Vaccine
Administration. The fee schedule’s
locality-adjusted payment rate files for
CY 2024 can be found on the CMS
Vaccine Pricing website at https://
www.cms.gov/medicare/payment/allfee-service-providers/medicare-part-bdrug-average-sales-price/vaccinepricing. Payment rate files for influenza,
pneumococcal and hepatitis B vaccine
administration can be found under the
‘‘Seasonal Flu Vaccine’’ tab, and
payment rate files for COVID–19
vaccines can be found under the
‘‘COVID–19 Vaccines & Monoclonal
Antibodies’’ tab. The CY 2025 payment
rates for Part B vaccine HCPCS codes
G0008, G0009, G0010 and 90480, with
the annual update applied for CY 2025,
will be made available at the time of
publication of the CY 2025 PFS final
rule, and Tables 45 and 46 in section
III.H.1.f. of this proposed rule provide
the CY 2025 projected payment rates for
those amounts.
We are also clarifying that RHC or
FQHC providers are eligible to bill
HCPCS code M0201 for an in-home
additional payment for Part B
preventive vaccine administration,
provided that a home visit meets all the
requirements of both part 405, subpart
X, for RHCs and FQHCs services
provided in the home, and
§ 410.152(h)(3)(iii) for the in-home
additional payment for Part B
preventive vaccine administration. More
information regarding the in-home
additional payment can be found at
section III.H.1.d of this proposed rule,
and current and projected payment rates
for M0201 can be found together with
Part B vaccine administration payment
rates mentioned above.
We emphasize that the statute at
section 1833(b) of the Act requires that
RHCs and FQHCs be paid at 100 percent
of reasonable cost for Part B vaccines
and their administration. Therefore,
payments for these services received at
the time they are furnished in RHCs and
FQHCs will need to be annually
reconciled with the facilities’ actual
vaccine and vaccine administration
costs, including the in-home additional
costs, on their cost reports. Due to the
operational systems changes needed to
facilitate payment through claims, we
propose that RHCs and FQHCs begin
billing for preventive vaccines and their
administration at the time of service, for
dates of service beginning on or after
July 1, 2025. This will also allow ample
time for CMS to release cost reporting
instructions and sub-regulatory
guidance with additional billing
instructions for RHCs and FQHCs to bill
Medicare Part B for preventive vaccines
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and their administration at the time of
service.
We believe that this proposal
addresses the comments and requests of
stakeholders who have suggested this
payment approach over the last several
years. We note that this payment
approach was mentioned in the Senate
Appropriations Committee’s
‘‘Explanatory Statement For
Departments Of Labor, Health And
Human Services, And Education, And
Related Agencies Appropriations Bill,
2021.’’ 308 That report referenced a
December 2019 white paper by the
National Association of Community
Health Centers, which noted that
‘‘FQHCs can face significant delays in
reimbursement for influenza and
pneumococcal vaccines.’’ 309 The
Committee thus encouraged CMS to
promote the ability of FQHCs to bill Part
B directly for vaccinations at the time of
service, with reconciliation of payments
at the time of cost report settlement.
We invite public comment on these
proposals. We would especially
appreciate comments on the benefits of
payments for vaccine costs billed at the
time of service, weighed against the
potential additional burdens of annual
reconciliation of vaccine claims
payments against actual vaccine costs.
6. Productivity Standards
a. Background
Productivity standards for RHCs were
first established on March 1, 1978 (43
FR 8260), and updated on December 1,
1982 (47 FR 54163–54165), to help
determine the average cost per patient
for Medicare reimbursement in RHCs.
These productivity screening guidelines
were intended to identify situations
where costs would not be allowed
without acceptable justification by the
clinic and limits on the amount of
payment (57 FR 24967). Physicians,
nurse practitioners (NPs), physician
assistants (PAs), and certified nurse
midwives (CNMs) are held to a
minimum number of visits per full time
employee (FTE), as discussed in section
80.4, chapter 13 of the Medicare Benefit
Policy Manual. The productivity
standards policy requires 4,200 visits
per full-time equivalent (FTE) physician
and 2,100 visits per FTE non-physician
practitioner (e.g., nurse practitioner,
physician assistant, or certified nurse
midwife). Physician and non-physician
practitioner productivity may be
combined and if so, the number of visits
308 https://www.appropriations.senate.gov/imo/
media/doc/LHHSRept.pdf.
309 https://www.nachc.org/wp-content/uploads/
2023/10/adult-imm-fqhc-white-paper-11–01–
2019.pdf.
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per full-time equivalent team is 6,300. If
actual visits are less than the
productivity standards, the average cost
per visit will be computed based on the
productivity standards rather than
actual visits, which would result in the
cost per visit to be lower than if actual
visits were used. In other words, if the
current productivity standards are not
met, the results would be a reduction in
the cost per visit, which could
negatively impact the RHC AIR and
reduce payments. There are exceptions
to the productivity standards that can be
made based on individual
circumstances that is at the discretion of
the MAC. We note that these standards
of 4,200 visits per FTE physician and
2,100 visit per FTE nonphysician
practitioner and 6,300 visits per
combined FTE have not been updated
since 1982. We also note similar
requirements to contain costs in this
way were not required in FQHCs or
other settings paid on reasonable cost.
Interested parties have requested that
CMS re-evaluate or remove the
productivity standards policy for RHCs
because they believe that the
environment today is very different than
when the RHC benefit began and that
the ‘‘visit per FTE’’ is too high for
practitioners to meet and results in
reducing the AIR. They also shared that
the productivity standards matter even
less now since the implementation of
the CAA, 2021 established payment
limits for all RHCs.
During the COVID–19 PHE, CMS
issued a combination of emergency
authority waivers, regulations,
enforcement discretion, and
subregulatory guidance to ensure and
expand access to care and to give health
care providers the flexibilities needed to
help keep people safe. RHCs expressed
concerns about how the productivity
standards might impact them during the
PHE. For example, many RHCs had
trouble meeting the productivity
standards due to a change in the way
they staffed their clinics and billed for
RHC services with increased
telecommunications services. RHCs
claimed that they were negatively
impacted even more so than other
health care settings because of these
requirements. We have long standing
guidance in the Medicare Benefit Policy
Manual, chapter 13, section 80.4 that
describes the MAC’s role in providing
flexibility to grant productivity
exceptions to RHCs who experienced
disruptions in staffing and services to
minimize the burden on RHCs. During
the PHE we reminded RHCs of the
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exception process in FAQs,310 and
provided instructions to MACs to
proactively reach out to RHCs
reminding them of the exception
process and to proactively grant
exceptions as necessary.
Section 130 of the CAA, 2021
restructured the payment limits for
RHCs beginning April 1, 2021. That is,
independent RHCs, provider-based
RHCs in a hospital with 50 or more
beds, and RHCs enrolled under
Medicare on or after January 1, 2021,
will receive a prescribed national
statutory payment limit per visit
increase over an 8-year period for each
year from 2021 through 2028. This
provision also established payment
limits for provider-based RHCs in a
hospital with less than 50 beds. See CY
2022 PFS final rule (86 FR 65199
through 65202) for more detailed
discussion.
Since the CAA, 2021 restructured the
payment limits for RHCs, and in some
cases established payment limits for
RHCs beginning April 1, 2021, we
believe that applying productivity
standards may no longer be necessary
with the payment limits set out by
Congress. We believe that the
productivity standards are outdated and
redundant with the CAA, 2021
provisions. Therefore, we are proposing
to remove productivity standards for
RHCs.
7. Proposed Rebasing of the FQHC
Market Basket
a. Background
Section 10501(i)(3)(A) of the
Affordable Care Act added section
1834(o) of the Act to establish a
payment system for the costs of FQHC
services under Medicare Part B based on
prospectively set rates. In the
Prospective Payment System (PPS) for
FQHC final rule published in the May
2, 2014 Federal Register (79 FR 25436),
we implemented a methodology and
payment rates for the FQHC PPS.
Beginning on October 1, 2014, FQHCs
began to transition to the FQHC PPS
based on their cost reporting periods,
and as of January 1, 2016, all FQHCs
have been paid under the FQHC PPS.
Section 1834(o)(2)(B)(ii) of the Act
requires that the payment for the first
year after the implementation year be
increased by the percentage increase in
the Medicare Economic Index (MEI).
Therefore, in CY 2016, the FQHC PPS
base payment rate was increased by the
MEI. The MEI at that time was based on
2006 data from the American Medical
Association (AMA) for self-employed
310 https://www.cms.gov/files/document/
03092020-covid-19-faqs-508.pdf.
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61795
physicians and was used in the PFS
sustainable growth rate (SGR) formula to
determine the conversion factor for
physician service payments. (See the CY
2014 PFS final rule (78 FR 74264) for a
complete discussion of the 2006-based
MEI.) Section 1834(o)(2)(B)(ii) of the Act
also requires that beginning in CY 2017,
the FQHC PPS base payment rate will be
increased by the percentage increase in
a market basket of FQHC goods and
services, or if such an index is not
available, by the percentage increase in
the MEI.
Beginning with CY 2017, FQHC PPS
payments were updated using a 2013based market basket reflecting the
operating and capital cost structures for
freestanding FQHC facilities (hereafter
referred to as the FQHC market basket).
A complete discussion of the 2013based FQHC market basket can be found
in the CY 2017 PFS final rule (81 FR
80393 through 80403). In the CY 2021
PFS final rule (85 FR 84699 through
84710), we rebased and revised the
FQHC market basket to reflect a 2017
base year.
For this CY 2025 PFS proposed rule,
we are proposing to rebase and revise
the 2017-based FQHC market basket to
reflect a 2022 base year, which would
maintain our historical frequency of
rebasing the market basket every four
years. The proposed 2022-based FQHC
market basket is primarily based on
Medicare cost report data for FQHCs for
2022, which are for cost reporting
periods beginning on and after October
1, 2021, and prior to October 1, 2022.
We propose to use data from cost
reports beginning in FY 2022 because
these data are the latest available
complete set of Medicare cost report
data for purposes of calculating cost
weights for the FQHC market basket at
the time of rulemaking.
In the following discussion, we
provide an overview of the proposed
FQHC market basket, describe the
methodologies for developing the
proposed 2022-based FQHC market
basket, and provide information on the
proposed price proxies. We then present
the CY 2025 FQHC market basket
update based on the proposed 2022based FQHC market basket.
b. Overview of the Proposed 2022-Based
FQHC Market Basket
Similar to the 2017-based FQHC
market basket, the proposed 2022-based
FQHC market basket is a fixed-weight,
Laspeyres-type price index. A Laspeyres
price index measures the change in
price, over time, of the same mix of
goods and services purchased in the
base period. Any changes in the
quantity or mix (that is, intensity) of
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goods and services purchased over time
are not measured. The index itself is
constructed using three steps. First, a
base period is selected (we propose to
use 2022 as the base period) and total
base period expenditures are estimated
for a set of mutually exclusive and
exhaustive expenditure categories, with
the proportion of total costs that each
category represents being calculated.
These proportions are called cost
weights. Second, each cost category is
matched to an appropriate price or wage
variable, referred to as a ‘‘price proxy.’’
In almost every instance, these price
proxies are derived from publicly
available statistical series that are
published on a consistent schedule
(preferably at least on a quarterly basis).
Finally, the cost weight for each cost
category is multiplied by the level of its
respective price proxy. The sum of these
products (that is, the cost weights
multiplied by their price index levels)
for all cost categories yields the
composite index level of the market
basket in a given period. Repeating this
step for other periods produces a series
of market basket index levels over time.
Dividing an index level for a given
period by an index level for an earlier
period produces a rate of growth in the
input price index over that timeframe.
As previously noted, the market basket
is described as a fixed-weight index
because it represents the change in price
over time of a constant mix (quantity
and intensity) of goods and services
needed to furnish FQHC services. The
effects on total expenditures resulting
from changes in the mix of goods and
services purchased subsequent to the
base period are not measured. For
example, a FQHC hiring more nurse
practitioners to accommodate the needs
of patients would increase the volume
of goods and services purchased by the
FQHC but would not be factored into
the price change measured by a fixedweight FQHC market basket. Only when
the index is rebased would changes in
the quantity and intensity be captured,
with those changes being reflected in
the cost weights. Therefore, we rebase
the market basket periodically so that
the cost weights reflect recent changes
in the mix of goods and services that
FQHCs purchase (FQHC inputs) to
furnish care between base periods.
c. Development of the Proposed 2022Based FQHC Market Basket Cost
Categories and Weights
We are inviting public comments on
our proposed methodology, discussed in
this section of this rulemaking, for
deriving the proposed 2022-based FQHC
market basket.
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(1) Use of Medicare Cost Report Data
The major types of costs underlying
the proposed 2022-based FQHC market
basket are derived from the Medicare
cost reports (CMS Form 224–14, OMB
Control Number 0938–1298) for
freestanding FQHCs. Specifically, we
use the Medicare cost reports for eleven
specific costs: FQHC Practitioner Wages
and Salaries, FQHC Practitioner
Employee Benefits, FQHC Practitioner
Contract Labor, Clinical Staff Wages and
Salaries, Clinical Staff Employee
Benefits, Clinical Staff Contract Labor,
Non-Health Staff Compensation,
Medical Supplies, Pharmaceuticals,
Fixed Assets, and Movable Equipment.
A residual category is then estimated
and reflects all remaining costs not
captured in the 11 types of costs
identified previously (such as nonmedical supplies and utilities).
The resulting proposed 2022-based
FQHC market basket cost weights reflect
Medicare allowable costs. We propose
to define Medicare allowable costs
centers for freestanding FQHC facilities
as the expenses reported on: Worksheet
A, lines 1 through 7, lines 9 through 12,
lines 23 through 36, and line 66. For the
proposed 2022-based FQHC market
basket, we are proposing to include data
from the cost center from Worksheet A,
line 66 (Telehealth) as effective for CY
2022 since CMS finalized a proposal to
revise the current regulatory language
for RHC or FQHC mental health visits to
include visits furnished using
interactive, real-time
telecommunications technology and for
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 (86 FR 65208
through 62511). As done with the 2017based FQHC market basket, we are
proposing to continue to exclude
Professional Liability Insurance (PLI)
costs from the total Medicare allowable
costs because FQHCs that receive
section 330 grant funds also are eligible
to apply for medical malpractice
coverage under Federally Supported
Health Centers Assistance Act
(FSHCAA) of 1992 (Pub. L. 102–501)
and FSHCAA of 1995 (Pub. L. 104–73
amending section 224 of the Public
Health Service Act).
Later in this section, we explain in
more detail how the costs for each of the
11 categories are derived. Prior to
estimating any costs, we apply three
basic edits. First, we only include the
last submitted cost report so there is no
double counting of a FQHC provider.
Second, we exclude providers that have
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less than half a year of reported cost
data; this edit excludes 175 FQHC
providers for 2022. Finally, we remove
any providers that did not report net
direct patient care expenses on the
FQHC cost report Worksheet A, line 37,
column 7; this edit excludes 717 FQHC
cost reports, or about 29 percent of
FQHC providers. If a provider does not
have reported costs, then we are unable
to use that provider’s costs to calculate
cost weights. We encourage providers to
report net direct patient care expenses
when reporting the data. After the three
edits, there are 1,713 remaining FQHC
providers in the 2022 data set that we
use to estimate cost expenditures for, or
roughly two-thirds of the total FQHCs in
the original Medicare cost report data
set.
(a) FQHC Practitioner Wages and
Salaries Costs
A FQHC practitioner is defined as one
of the following occupations:
physicians; nurse practitioners (NPs);
physician assistants (PAs); certifiednurse midwife (CNMs); clinical
psychologist (CPs); and clinical social
workers (CSWs). We propose to
calculate FQHC Practitioner Wages and
Salaries Costs using three steps. First,
we propose to calculate FQHC
Practitioner Compensation Costs as
equal to the net expenses (that is, costs
after reclassifications and adjustments)
as reported on Worksheet A, column 7,
lines 23, 25, 26, 29, 30, and 31. These
lines represent the total net costs (after
reclassifications and adjustments) for
physicians, PAs, NPs, CNMs, CPs, and
CSWs.
Second, we propose to further divide
the FQHC Practitioner Compensation
Costs for these occupations into wages
and salaries, employee benefits, and
contract labor costs based on the ratios
of practitioner wages and salaries,
practitioner employee benefits, and
practitioner contract labor costs to the
sum of these three groups of costs. We
do this by applying the ratios of
practitioner wages and salaries,
practitioner employee benefits, and
practitioner contract labor to the net
expense FQHC Practitioner
Compensation Costs, and the
determination of these ratios is
described below. We propose to derive
the practitioner wages and salaries costs
as the sum of direct care wages and
salaries reported on Worksheet A,
column 1, lines 23, 25, 26, 29, 30, and
31. These lines represent the wages and
salaries costs for physicians, PAs, NPs,
CNMs, CPs, and CSWs. We propose to
derive the practitioner employee
benefits costs for these occupations as
the sum of costs reported on Worksheet
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S–3, part II, column 2, lines 2, 3, 4, 7,
8, and 9. These lines represent the
employee benefits costs for physicians,
PAs, NPs, CNMs, CPs, and CSWs. We
propose to derive the practitioner
contract labor costs for these
occupations as the costs reported on
Worksheet S–3, part II, column 1, lines
2, 3, 4, 7, 8, and 9. These lines represent
the contract labor costs for physicians,
PAs, NPs, CNMs, CPs, and CSWs. This
was the same method used to calculate
the ratios to split the FQHC Practitioner
Compensation Costs as was done for the
2017-based FQHC market basket.
Approximately 56 percent of FQHCs
that reported direct patient care wages
and salaries costs also reported
employee benefits costs data and
approximately 99 percent of FQHCs that
reported direct patient care wages and
salaries costs also reported contract
labor cost data on Worksheet S–3, part
II for 2022. This is higher reporting than
the percent of FQHCs reporting the
same data compared to the 2017-based
FQHC market basket, which had a 45
percent and 66 percent reporting
incidence for the 2017 cost report data.
We are encouraged by this improvement
in the data and continue to encourage
all providers to report these data on the
Medicare cost report.
The final step in the process to derive
the FQHC Practitioner Wages and
Salaries costs is to apply the ratio of
practitioner wages and salaries to the
sum of practitioner wages and salaries
costs, practitioner employee benefits
costs, and practitioner contract labor
costs times the FQHC Practitioner
Compensation costs (representing the
net expenses for each occupation as
reported on Worksheet A column 7) as
described above. This calculation is
done for each occupation individually
(physicians, PAs, NPs, CNMs, CPs, and
CSWs). The resulting proposed FQHC
Practitioner Wages and Salaries costs
are equal to the sum of each
occupation’s wages and salary costs.
This is the same methodology that was
used for the 2017-based FQHC market
basket.
As stated in the CY 2022 PFS final
rule (86 FR 65209), effective for CY 2022
FQHC mental health visits furnished
using interactive, real-time
telecommunications technology are paid
for at the same rate as other FQHC visits
when these services are furnished inperson; therefore, we propose to include
telehealth wages and salaries costs in
the FQHC Practitioner Wages and
Salaries cost category. We propose to
derive telehealth wages and salaries by
multiplying the net telehealth costs (as
reported on Worksheet A, column 7,
line 66) times the ratio of telehealth
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wages and salaries (as reported on
Worksheet A, column 1, line 66) to the
sum of telehealth costs (the sum of
Worksheet A, column 1 and 2, line 66).
(b) FQHC Practitioner Employee
Benefits Costs
To calculate FQHC Practitioner
Employee Benefits costs, we propose to
use a similar methodology as used to
calculate the FQHC Practitioner Wages
and Salaries costs. We propose to apply
the ratio of practitioner employee
benefits as described above to the FQHC
Practitioner Compensation costs
(representing the net expenses for each
occupation as reported on Worksheet A
column 7) as defined in the section
III.B.7.(c)(1)(a). This calculation is done
for each occupation individually
(physicians, PAs, NPs, CNMs, CPs, and
CSWs). The FQHC Practitioner
Employee Benefits costs are equal to the
sum of each occupation’s employee
benefits costs. This is the same
methodology that was used for the 2017based FQHC market basket. As stated
previously, effective for CY 2022,
telehealth services are covered under
the FQHC PPS; therefore, we propose to
also include in the FQHC Practitioner
Employee Benefits the telehealth
employee benefits. We propose to
estimate telehealth employee benefits by
multiplying telehealth wages and
salaries (as described in section
III.B.7.(c)(1)(a)) times the ratio of total
direct patient care facility benefits
(Worksheet S3 Part II, column 2, line 1)
to total facility direct patient care
salaries (the sum of Worksheet A,
columns 1 and 2, lines 23 and 25
through 36), which is estimated to be 21
percent on average. This ratio is referred
to as the overall employee benefit share
and represents the ratio of employee
benefits to wages and salaries for all
patient care costs reported by FQHCs.
(c) FQHC Practitioner Contract Labor
Costs
To calculate FQHC Practitioner
Contract Labor Costs, we propose to use
a similar methodology as used to
calculate FQHC Practitioner Wages and
Salaries and FQHC Practitioner
Employee Benefit Costs. We propose to
multiply the ratio of practitioner
contract labor, as described above, by
the FQHC Practitioner Compensation
costs (representing the net expenses for
each occupation as reported on
Worksheet A column 7) as defined in
section III.B.7.(c)(1)(a). This calculation
is done for each occupation individually
(physicians, PAs, NPs, CNMs, CPs, and
CSWs). The FQHC Practitioner Contract
Labor costs are equal to the sum of each
occupation’s contract labor costs plus
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61797
all net expenses reported for Physicians
Services Under Agreement from
Worksheet A, column 7, line 24. This is
the same methodology used for the
2017-based FQHC market basket.
(d) Clinical Staff Wages and Salaries
Costs
We propose to calculate Clinical Staff
Wages and Salaries Costs using three
steps. First, we propose to define
Clinical Staff Compensation costs as the
sum of net expenses (that is, costs after
reclassifications and adjustments) as
reported on Worksheet A, column 7,
lines 27, 28, 32, 33, 34, 35, and 36.
Clinical Staff Compensation includes
any health-related clinical staff who do
not fall under the definition of a FQHC
Practitioner. These lines represent the
net expenses for visiting RNs, visiting
LPNs, laboratory technicians, registered
dietician/Certified DSMT/MNT
educators, PTs, OTs, and other allied
health personnel.
Second, we propose to further divide
the Clinical Staff Compensation costs
for these occupations into wages and
salaries, employee benefits, and contract
labor costs based on the ratio of clinical
staff wages and salaries, clinical staff
employee benefits, and clinical staff
contract labor costs to the sum of these
three groups of costs. We do this by
applying the ratio of clinical staff wages
and salaries, clinical staff employee
benefits, and clinical staff contract labor
to the net expense Clinical Staff
Compensation costs, and the
determination of these ratios is
described later in this section. We
propose to derive clinical staff wages
and salaries costs as the sum of direct
care cost salaries as reported on
Worksheet A, column 1, lines 27, 28, 32,
33, 34, 35, and 36. These lines represent
the wages and salaries costs for visiting
registered nurses (RNs), visiting
licensed practical nurses (LPNs),
laboratory technicians, registered
dietician/Certified DSMT/MNT
educators, physical therapists (PTs),
occupational therapists (OTs), and other
allied health personnel. We propose to
derive the clinical staff employee
benefits costs for these occupations as
the sum of costs reported on Worksheet
S–3, part II, column 2, lines 5, 6, 10, 11,
12, 13, and 14. These lines represent the
employee benefits costs for visiting RNs,
visiting LPNs, laboratory technicians,
registered dietician/Certified DSMT/
MNT educators, PTs, OTs, and other
allied health personnel. Similarly, we
propose to calculate clinical staff
contract labor costs for these
occupations as the costs reported on
Worksheet S–3, part II, column 1, lines
5, 6, 10, 11, 12, 13, and 14. These lines
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Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
represent the contract labor costs for
visiting RNs, visiting LPNs, laboratory
technicians, registered dietician/
Certified DSMT/MNT educators, PTs,
OTs, and other allied health personnel.
This was the same method used to
calculate the ratios to split the Clinical
Staff Compensation net expenses as was
done for the 2017-based FQHC market
basket.
The final step in the process to derive
the Clinical Staff Wages and Salaries
costs is to apply the ratio of clinical staff
wages and salaries calculated in the
prior step to the Clinical Staff
Compensation costs (representing the
net expenses for each occupation as
reported on Worksheet A column 7) as
described above. This calculation is
done for each occupation individually
(visiting RNs, visiting LPNs, laboratory
technicians, registered dietician/
Certified DSMT/MNT educators, PTs,
OTs, and other allied health personnel).
The Clinical Staff Wages and Salaries
costs is equal to the sum of each
occupation’s wages and salary costs.
This is the same methodology that was
used for the 2017-based FQHC market
basket.
lotter on DSK11XQN23PROD with PROPOSALS2
(e) Clinical Staff Employee Benefits
Costs
To calculate Clinical Staff Employee
Benefit costs, we propose to use a
similar methodology as used to
calculate the Clinical Staff Wages and
Salaries costs. We propose to multiply
the ratio of clinical staff employee
benefits, as described above by the
Clinical Staff Compensation costs
(representing the net expenses for each
occupation as reported on Worksheet A
column 7) as defined in the section
III.B.7.(c)(1)(d). This calculation is done
for each occupation individually
(visiting RNs, visiting LPNs, laboratory
technicians, registered dietician/
Certified DSMT/MNT educators, PTs,
OTs, and other allied health personnel).
The Clinical Staff Employee Benefits
costs are equal to the sum of each
occupation’s Employee Benefits costs.
This is the same methodology that was
used for the 2017-based FQHC market
basket.
(f) Clinical Staff Contract Labor Costs
To calculate Clinical Staff Contract
Labor costs, we propose to use a similar
methodology as used to calculate
Clinical Staff Wages and Salaries Costs
and Clinical Staff Benefit Costs. We
propose to multiply the ratio of clinical
staff contract labor costs, as described
above, by the Clinical Staff
Compensation costs (representing the
net expenses for each occupation as
reported on Worksheet A column 7) as
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defined in the section III.B.7.(c)(1)(d).
This calculation is done for each
occupation individually (visiting RNs,
visiting LPNs, laboratory technicians,
registered dietician/Certified DSMT/
MNT educators, PTs, OTs, and other
allied health personnel). The Clinical
Staff Contract Labor costs are equal to
the sum of each occupation’s contract
labor costs. This is the same
methodology that was used for the 2017based FQHC market basket.
(g) Non-Health Staff Compensation
Costs
We propose to define Non-Health
Staff Compensation costs using net
expenses (that is, costs after
reclassifications and adjustments) as the
estimated share of compensation costs
from Worksheet A, column 7 for lines 3,
4, 5, 6, 7, 9, 10, 11, and 12. These lines
represent the net expenses for the
employee benefits department,
administrative & general services, plant
operations & maintenance, janitorial,
medical records, pharmacy, medical
supplies, transportation, and other
general services. Since the net expenses
for the General Service Cost centers
include both compensation and other
costs, we estimate the share of net
expenses for each general service cost
center that reflects compensation costs.
First, we estimate a share of non-health
staff wages and salaries costs for each
general service cost center as reported
on Worksheet A, column 1 for lines 3,
4, 5, 6, 7, 9, 10, 11, and 12 divided by
Worksheet A, column 1 and 2 for lines
3, 4, 5, 6, 7, 9, 10, 11, and 12. Then, we
multiply the Non-Health Staff net
expenses (that is, costs after
reclassifications and adjustments) by the
non-health staff wages and salaries
share to derive estimated Non-Health
Staff Wages and Salaries costs for each
general service cost center (lines 3–7
and lines 9–12). Second, we estimate
Non-Health Staff Employee Benefit costs
by multiplying the Non-Health Staff
Wages and Salaries costs (step one) by
the overall employee benefit share as
described in section III.B.7.(c)(1)(b), or
21 percent. Finally, we sum the derived
Non-Health Staff Wages and Salaries
costs and the derived Non-Health Staff
Employee Benefits costs for each general
service cost center (lines 3–7 and lines
9–12) to calculate Non-Health Staff
Compensation costs. This is the same
methodology used for the 2017-based
FQHC market basket.
(h) Pharmaceutical Costs
We propose to calculate
Pharmaceutical costs as the noncompensation costs for the Pharmacy
cost center. We define this as Worksheet
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A, column 7, line 9 less derived
pharmacy compensation costs. Derived
pharmacy compensation costs are
included in the Non-health Staff
Compensation costs described in section
III.B.7.(c)(1)(g). We note that the only
pharmaceutical costs eligible for
inclusion in the FQHC PPS market
basket are those reported on line 9 of
Worksheet A. These pharmaceutical
costs would include only the costs of
routine drugs (both prescription and
over the counter), pharmacy supplies,
and pharmacy services, provided
incident to an FQHC visit. Other types
of drugs and pharmacy supplies costs
not included in this category are those
reported on line 67 (drugs charged to
patients), line 77 (retail pharmacy), line
48 (pneumococcal vaccine), and line 49
(influenza vaccine, COVID–19, and
monoclonal antibody products for
treatment of COVID–19), as these costs
are reimbursed to FQHC providers
outside of the FQHC PPS payment. The
derived pharmacy compensation costs
are equal to the sum of the estimated
pharmacy wages and salaries and
pharmacy employee benefits costs. This
is the same methodology used for the
2017-based FQHC market basket.
(i) Medical Supplies Costs
We propose to calculate Medical
Supplies costs as the non-compensation
costs for the Medical Supplies costs
center. We define this as Worksheet A,
column 7, line 10 less derived medical
supplies compensation costs. Derived
medical supplies compensation costs
are included in the Non-health Staff
Compensation costs described in section
III.B.7.(c)(1)(g). The derived medical
supplies compensation costs are equal
to the sum of the estimated medical
supplies wages and salaries and medical
supplies benefits costs. This is the same
methodology used for the 2017-based
FQHC market basket.
(j) Fixed Assets Costs
We propose to define Fixed Asset
costs to be equal to costs reported on
Worksheet A, line 1, column 7 of the
Medicare cost report. This is the same
methodology used for the 2017-based
FQHC market basket.
(k) Movable Equipment Costs
We propose to define Movable
Equipment costs to be equal to the
capital costs as reported on Worksheet
A, line 2, column 7. This is the same
methodology used for the 2017-based
FQHC market basket.
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(2) Proposed Major Cost Category
Computation
After we derive costs for the major
cost categories for each provider using
the Medicare cost report data as
previously described, we propose to
trim the data for outliers. For each of the
11 major cost categories, we propose to
divide the calculated costs for the
category by total Medicare allowable
costs calculated for the provider to
obtain cost weights for the universe of
FQHC providers after basic trims
described in section III.B.7.(c). For the
proposed 2022-based FQHC market
basket, total Medicare allowable costs
would be equal to total net expenses
(after reclassifications and adjustments)
reported on: Worksheet A, column 7, for
lines 1 through 7, lines 9 through 12;
lines 23 through 36, and line 66. This
is the same method used to derive total
Medicare allowable costs for the 2017based FQHC market basket with the
only difference being that we now
include the net expenses for line 66,
telehealth because as previously
described, effective for CY 2022 CMS
finalized the policy for mental health
visits furnished using interactive, realtime telecommunications technology to
be paid in the same way they currently
do when these services are furnished inperson (86 FR 65208 through 62511).
For the FQHC Practitioner Wages and
Salaries, FQHC Practitioner Employee
Benefits, FQHC Practitioner Contract
Labor, Clinical Staff Wages and Salaries,
Clinical Staff Employee Benefits,
Clinical Staff Contract Labor, NonHealth Staff Compensation,
Pharmaceuticals, Medical Supplies,
Fixed Assets, and Movable Equipment
cost weights, after excluding cost
weights that are less than or equal to
zero, we propose to then remove those
providers whose derived cost weights
fall in the top and bottom 5 percent of
provider-specific derived cost weights
to ensure the exclusion of outliers. A 5
percent trim is the standard trim
61799
applied to the mean cost weights in
most CMS market baskets and is
consistent with the trimming used in
the 2017-based FQHC market basket.
After the outliers have been excluded,
we sum the costs for each category
across all remaining providers. We
propose to then divide this by the sum
of total Medicare allowable costs across
all remaining providers to obtain a cost
weight for the proposed 2022-based
FQHC market basket for the given
category. This trimming process is done
for each cost weight separately.
Finally, we propose to calculate the
residual ‘‘All Other’’ cost weight that
reflects all remaining costs that are not
captured in the 11 major cost categories
listed. Table 25 provides the resulting
cost weights for these major cost
categories derived from the Medicare
cost reports.
Table 25 displays the proposed 2022based FQHC market basket cost weights
compared to the 2017-based FQHC
market basket cost weights.
TABLE 25: Major Cost Categories as Derived from Medicare Cost Reports
As we did for the 2017-based FQHC
market basket, we propose to allocate
the Contract Labor cost weight to the
Wages and Salaries and Employee
Benefits cost weights based on their
relative proportions under the
assumption that contract labor costs
comprise both wages and salaries and
employee benefits for both FQHC
Practitioners and Clinical Staff. The
contract labor allocation proportion for
Wages and Salaries is equal to the
Wages and Salaries cost weight as a
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percent of the sum of the Wages and
Salaries cost weight and the Employee
Benefits cost weight. This percentage
based on the proposed 2022-based
FQHC cost weights is 82.5 percent for
FQHC practitioners and 80.8 percent for
clinical staff. Therefore, we propose to
allocate 82.5 percent of the FQHC
Practitioner Contract Labor cost weight
to the FQHC Practitioner Wages and
Salaries cost weight and 17.5 percent to
the FQHC Practitioner Employee
Benefits cost weight. Similarly, we
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2017-Based
FQHC Cost Report
Weights
(Percent)
28.4
19.4
4.5
4.6
16.8
12.9
3.1
0.9
27.2
2.4
2.2
4.4
2.0
16.5
propose to allocate 80.8 percent of the
Clinical Staff Contract Labor cost weight
to the Clinical Staff Wages and Salaries
cost weight and 19.2 percent to the
Clinical Staff Employee Benefits cost
weight. Table 26 shows the FQHC
Practitioner and Clinical Staff Wages
and Salaries and Employee Benefits
proposed 2022-based cost weights after
the contract labor cost weight has been
allocated. Table 26 also includes the
comparison of the weights to the 2017-
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EP31JY24.053
lotter on DSK11XQN23PROD with PROPOSALS2
Maior Cost Cate2ories
FQHC Practitioner Compensation
FOHC Practitioner Wages and Salaries
FQHC Practitioner Employee Benefits
FOHC Practitioner Contract Labor
Clinical Staff Compensation
Clinical Staff Wages and Salaries
Clinical Staff Employee Benefits
Clinical Staff Contract Labor
Non-Health Staff Compensation
Pharmaceuticals
Medical Suoolies
Fixed Assets
Movable Equipment
All Other (Residual)
Note: Totals may not sum to 100.0 due to rounding
Proposed 2022-Based
FQHC Cost Report
Weights
(Percent)
24.8
17.1
3.6
4.1
15.3
11.8
2.8
0.6
28.4
3.2
2.4
5.0
2.2
18.7
61800
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
based cost weights for the same
categories.
TABLE 26: Wages and Salaries and Employee Benefits Cost Weights After Contract Labor
Allocation
lotter on DSK11XQN23PROD with PROPOSALS2
(3) Derivation of the Detailed Operating
Cost Weights
To further divide the ‘‘All Other’’
residual cost weight estimated from the
2022 Medicare cost report data into
more detailed cost categories, we
propose to use the 2017 Benchmark
Input-Output (I–O) ‘‘Use Tables/Before
Redefinitions/Purchaser Value’’ for
NAICS 621100, Offices of Physicians,
published by the Bureau of Economic
Analysis (BEA). We note that the BEA
benchmark I–O data is used to further
disaggregate residual costs in other CMS
market baskets. Therefore, we note that
we believe the data from this industry
are the most technically appropriate for
disaggregation of the residual net
expenses since both physician offices
and FQHCs provide similar types of
care. These data are publicly available at
https://www.bea.gov/industry/inputoutput-accounts-data. For the 2017based FQHC market basket, we used the
2012 Benchmark Input-Output (I–O)
‘‘Use Tables/Before Redefinitions/
Purchaser Value’’ for NAICS 621100,
Offices of Physicians, published by the
BEA.
The BEA Benchmark I–O data are
scheduled for publication every 5 years
with the most recent data available for
2017. The 2017 Benchmark I–O data are
derived from the 2017 Economic Census
and are the building blocks for BEA’s
economic accounts. Therefore, they
represent the most comprehensive and
complete set of data on the economic
processes or mechanisms by which
output is produced and distributed.311
BEA also produces Annual I–O
estimates. However, while based on a
similar methodology, these estimates
reflect less comprehensive and less
detailed data sources and are subject to
revision when benchmark data become
311 https://www.bea.gov/papers/pdf/IOmanual_
092906.pdf.
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Proposed 2022Based Clinical
Staff
15.3
12.4
2.9
2017-Based
FQHC
Practitioner
28.4
23.l
5.4
available. Instead of using the less
detailed Annual I–O data, we propose to
inflate the 2017 Benchmark I–O data
forward to 2022 by applying the annual
price changes from the respective price
proxies to the appropriate market basket
cost categories that are obtained from
the 2017 Benchmark I–O data. We
repeat this practice for each year. We
then calculate the cost shares that each
cost category represents of the 2017 data
inflated to 2022. These resulting 2022
cost shares were applied to the ‘‘All
Other’’ residual cost weight to obtain
the detailed cost weights for the
proposed 2022-based FQHC market
basket. For example, the cost for
Medical Equipment represents 7.8
percent of the sum of the ‘‘All Other’’
2017 Benchmark I–O Offices of
Physicians Expenditures inflated to
2022. Therefore, the proposed Medical
Equipment cost weight represents 7.8
percent of the proposed 2022-based
FQHC market basket’s ‘‘All Other’’ cost
category (18.7 percent), yielding a
Medical Equipment cost weight of 1.5
percent in the proposed 2022-based
FQHC market basket (0.078 × 18.7
percent = 1.5 percent).
Using this methodology, we propose
to derive six detailed FQHC market
basket cost category weights from the
proposed 2022-based FQHC market
basket residual cost weight (18.7
percent). These categories are: (1)
Utilities; (2) Medical Equipment; (3)
Miscellaneous Products; (4)
Professional, Scientific, and Technical
Services; (5) Administrative and
Facilities Support Services; and (6) All
Other Services.
(4) Proposed 2022-Based FQHC Market
Basket Cost Categories and Weights
Table 27 shows the cost categories
and cost weights for the proposed 2022based FQHC market basket compared to
the 2017-based FQHC market basket.
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2017-Based
Clinical Staff
16.8
13.6
3.3
The Total Compensation cost weight of
68.5 percent (sum of FQHC Practitioner
Compensation, Clinical Staff
Compensation, and Non-health Staff
Compensation) calculated from the
Medicare cost reports for the proposed
2022-based FQHC market basket is 4.1
percentage points lower than the total
compensation cost weight for the 2017based FQHC market basket (72.6
percent). The decrease in the
compensation cost weight between the
2017-based and the proposed 2022based market basket is stemming from
the decreasing FQHC Practitioner and
Clinical Staff Compensation cost
weights. The proposed 2022-based cost
weights for FQHC Practitioner and
Clinical Staff Compensation are 5.3
percentage points lower compared to
the 2017-based FQHC market basket,
while the Non-Health Staff
Compensation cost weight is 1.2
percentage points higher. Analysis of
the cost report data shows that the
decline in the health-related
compensation cost weights is stemming
from a change in the mix of healthrelated workers from higher-paid to
lower-paid occupations. Specifically,
there has been a shift in full time
equivalents (FTEs) from physicians to
nurse practitioners and a shift from
registered and licensed practical nurses
to other allied health personnel.
Additionally, the proposed 2022-based
Pharmaceuticals cost weight, NonHealth Staff Compensation costs weight,
and the Capital cost weight, are each
roughly 1 percentage point higher than
the cost weight in the 2017-based FQHC
market basket.
We note that our analysis of the
Medicare cost report data over time
shows the general trends in these cost
weights (particularly for the Total
Compensation and Pharmaceuticals cost
weights) began after 2017 with about
half of the cost weight changes
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Proposed 2022Based FQHC
Practitioner
Comoensation
24.8
Wages and Salaries
20.5
Emolovee Benefits
4.3
*Totals may not sum due to rounding
Major Cost Categories
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
occurring between 2017 and 2019.
Consistent with our historical frequency
of rebasing the other CMS market
baskets, we believe it is important to
rebase the FQHC market basket every
four to five years to reflect the more
recent data and changing cost structure.
We are soliciting comments on our
61801
proposal to rebase and revise the market
basket to reflect a 2022 base year.
TABLE 27: Proposed 2022-Based FQHC Market Basket Cost Weights Compared to 2017Based FQHC Market Basket Cost Wei hts
Clinical Staff Co
Clinical Staff
Clinical StafIE
Non-Health Sta
All Other Products
Pharmaceuticals
Utilities
n
Salaries
enefits
Miscellaneous Products
All Other Services
Professional, Scientific, and Technical Services
Administrative and Facilities Su ort Services
All Other Services
Ca ital-Related Costs
Fixed Assets
Movable E ui ment
Note: Totals may not sum due to rounding.
lotter on DSK11XQN23PROD with PROPOSALS2
d. Selection of Price Proxies
After developing the cost weights for
the proposed 2022-based FQHC market
basket, we selected the most appropriate
wage and price proxies currently
available to represent the rate of price
change for each expenditure category.
For most of the cost categories, we rely
on using the price proxies based on U.S.
Bureau of Labor Statistics (BLS) data, as
they produce indexes that best meet the
criteria of reliability, timeliness,
availability, and relevance, and group
them into one of the following BLS
categories:
• Employment Cost Indexes.
Employment Cost Indexes (ECIs)
measure the rate of change in
employment wage rates and employer
costs for employee benefits per hour
worked. These indexes are fixed-weight
indexes and strictly measure the change
in wage rates and employee benefits per
hour. ECIs are superior to Average
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100.0
68.5
24.8
20.5
4.3
15.3
12.4
2.9
28.4
9.8
3.2
0.5
1.5
2.4
2.3
14.5
8.6
1.5
4.4
7.2
5.0
2.2
Hourly Earnings (AHE) as price proxies
for input price indexes because they are
not affected by shifts in occupation or
industry mix, and because they measure
pure price change and are available by
both occupational group and by
industry. The industry ECIs are based
on the North American Industry
Classification System (NAICS) and the
occupational ECIs are based on the
Standard Occupational Classification
System (SOC).
• Producer Price Indexes. Producer
Price Indexes (PPIs) measure the average
change over time in the selling prices
received by domestic producers for their
output. The prices included in the PPI
are from the first commercial
transaction for many products and some
services (https://www.bls.gov/ppi/).
• Consumer Price Indexes. Consumer
Price Indexes (CPIs) measure the
average change over time in the prices
paid by urban consumers for a market
basket of consumer goods and services
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100.0
72.6
28.5
23.1
5.4
16.9
13.6
3.3
27.2
8.5
2.4
0.6
1.2
2.2
2.2
12.6
6.4
1.7
4.5
6.4
4.4
2.0
(https://www.bls.gov/cpi/). CPIs are only
used when the purchases are similar to
those of retail consumers rather than
purchases at the producer level, or if no
appropriate PPIs are available.
We evaluate the price proxies using
the criteria of reliability, timeliness,
availability, and relevance:
• Reliability. Reliability indicates that
the index is based on valid statistical
methods and has low sampling
variability. Widely accepted statistical
methods ensure that the data were
collected and aggregated in a way that
can be replicated. Low sampling
variability is desirable because it
indicates that the sample reflects the
typical members of the population.
(Sampling variability is variation that
occurs by chance because only a sample
was surveyed rather than the entire
population.)
• Timeliness. Timeliness implies that
the proxy is published regularly,
preferably at least once a quarter. The
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Total
Com ensation
FQHC Practitioner Com ensation
F HC Practitioner W: es and Salaries
61802
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
market baskets are updated quarterly,
and therefore, it is important for the
underlying price proxies to be up-todate, reflecting the most recent data
available. We believe that using proxies
that are published regularly (at least
quarterly, whenever possible) helps to
ensure that we are using the most recent
data available to update the market
basket. We strive to use publications
that are disseminated frequently,
because we believe that this is an
optimal way to stay abreast of the most
current data available.
• Availability. Availability means that
the proxy is publicly available. We
prefer that our proxies are publicly
available because this will help ensure
that our market basket updates are as
transparent to the public as possible. In
addition, this enables the public to be
able to obtain the price proxy data on
a regular basis.
• Relevance. Relevance means that
the proxy is applicable and
representative of the cost category
weight to which it is applied.
The CPIs, PPIs, and ECIs that we have
selected to use in the proposed 2022based FQHC market basket meet these
criteria. Therefore, we believe that they
continue to be the best measures of
price changes for the cost categories to
which they would be applied.
Table 28 lists all price proxies we
propose to use in the proposed 2022based FQHC market basket. Below is a
detailed explanation of the price proxies
we propose for each cost category.
(1) Price Proxies for the Proposed 2022Based FQHC Market Basket
lotter on DSK11XQN23PROD with PROPOSALS2
(a) FQHC Practitioner Wages and
Salaries
We propose to use the ECI for Wages
and Salaries for Private Industry
Workers in Professional and Related
(BLS series code CIU2010000120000I) to
measure price growth of this category.
There is no specific ECI for physicians
or FQHC Practitioners, and therefore,
we propose to use an index that is based
on professionals that receive advanced
training similar to those performing at
the FQHC Practitioner level of care. This
index is consistent with the price proxy
used to measure wages and salaries
inflation pressure for physicians own
time in the Medicare Economic Index
(MEI) and is based on the MEI technical
panel recommendation from 2012 for
more details see the CY 2014 PFS final
rule (78 FR 74266 through 74271).
Additionally, this is the same price
proxy used for the FQHC Practitioner
Wages and Salaries cost category in the
2017-based FQHC market basket (85 FR
84708).
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(b) FQHC Practitioner Employee
Benefits
We propose to use the ECI for Total
Benefits for Private Industry Workers in
Professional and Related to measure
price growth of this category. This ECI
is calculated using the ECI for Total
Compensation for Private Industry
Workers in Professional and Related
(BLS series code CIU1016220000000I)
and the relative importance of wages
and salaries within total compensation.
This is the same price proxy used for
the FQHC Practitioner Employee
Benefits cost category in the 2017-based
FQHC market basket (85 FR 84708).
(c) Clinical Staff Wages and Salaries
We propose to use the ECI for Wages
and Salaries for all Civilian Workers in
Health Care and Social Assistance (BLS
series code CIU1026200000000I) to
measure the price growth of this cost
category. This cost category consists of
wage and salary costs for Nurses,
Laboratory Technicians, and all other
healthcare staff not included in the
FQHC Practitioner compensation
categories. Based on the clinical staff
composition of these workers, we
believe that the ECI for health-related
workers is an appropriate proxy to
measure wage and salary price pressures
for these workers. This is the same price
proxy used for the Clinical Staff Wages
and Salaries cost category in the 2017based FQHC market basket (85 FR
84708).
(d) Clinical Staff Employee Benefits
We propose to use the ECI for Total
Benefits for all Civilian Workers in
Health Care and Social Assistance to
measure price growth of this category.
This ECI is calculated using the ECI for
Total Compensation for all Civilian
Workers in Health Care and Social
Assistance (BLS series code
CIU1016220000000I) and the relative
importance of wages and salaries within
total compensation. This is the same
price proxy used for the Clinical Staff
Employee Benefits cost category in the
2017-based FQHC market basket (85 FR
84708).
(e) Non-Health Staff Compensation
We propose to use the ECI for Total
Compensation for Private Industry
Workers in Office and Administrative
Support (BLS series code
CIU2010000220000I) to measure the
price growth of this cost category. The
Non-health Staff Compensation cost
weight is predominately attributable to
administrative and facility type
occupations, as reported in the data
from the Medicare cost reports. This is
the same price proxy used for the Non-
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Health Staff Compensation cost category
in the 2017-based FQHC market basket
(85 FR 84708).
(f) Pharmaceuticals
We propose to use the PPI
Commodities for Pharmaceuticals for
Human Use, Prescription (BLS series
code WPUSI07003) to measure the price
growth of this cost category. This price
proxy is used to measure prices of
Pharmaceuticals in other CMS market
baskets, such as the 2018-based
Inpatient Prospective Payment System
market basket and is the same price
proxy used for the Pharmaceuticals cost
category in the 2017-based FQHC
market basket (85 FR 84708).
(g) Utilities
We propose to use the CPI for Fuel
and Utilities (BLS series code
CUUR0000SAH2) to measure the price
growth of this cost category. This is the
same price proxy used for the Utilities
cost category in the 2017-based FQHC
market basket (85 FR 84708).
(h) Medical Equipment
We propose to use the PPI
Commodities for Surgical and Medical
Instruments (BLS series code WPU1562)
as the price proxy for this category. This
is the same price proxy used for the
Medical Equipment cost category in the
2017-based FQHC market basket (85 FR
84708).
(i) Medical Supplies
We propose to use a 50/50 blended
index that comprises the PPI
Commodities for Medical and Surgical
Appliances and Supplies (BLS series
code WPU156301) and the CPI–U for
Medical Equipment and Supplies (BLS
series code CUUR0000SEMG). The 50/
50 blend is used in all market baskets
where we do not have an accurate split
available. We note that we believe
FQHCs purchase the types of supplies
contained within these proxies,
including such items as bandages,
dressings, catheters, intravenous
equipment, syringes, and other general
disposable medical supplies, via
wholesale purchase, as well as at the
retail level. Consequently, we propose
to combine the two aforementioned
indexes to reflect those modes of
purchase. This is the same price proxy
used for the Medical Supplies cost
category in the 2017-based FQHC
market basket (85 FR 84708 through
84709).
(j) Miscellaneous Products
We propose to use the CPI for All
Items Less Food and Energy (BLS series
code CUUR0000SA0L1E) to measure the
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Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
price growth of this cost category. We
believe that using the CPI for All Items
Less Food and Energy is appropriate as
it reflects a general level of inflation.
This is the same price proxy used for
the Miscellaneous cost category in the
2017-based FQHC market basket (85 FR
84709).
(k) Professional, Scientific, and
Technical Services
We propose to use the ECI for Total
Compensation for Private Industry
Workers in Professional, Scientific, and
Technical Services (BLS series code
CIU2015400000000I) to measure the
price growth of this cost category. This
is the same price proxy used for the
Professional, Scientific, and Technical
Services cost category in the 2017-based
FQHC market basket (85 FR 84709).
(l) Administrative and Facilities
Support Services
We propose to use the ECI Total
Compensation for Private Industry
Workers in Office and Administrative
Support (BLS series code
CIU2010000220000I) to measure the
price growth of this cost category. This
is the same price proxy used for the
Administrative and Facilities Support
Services cost category in the 2017-based
FQHC market basket (85 FR 84709).
(m) All Other Services
We propose to use the ECI for Total
Compensation for Private Industry
Workers in Service Occupations (BLS
series code CIU2010000300000I) to
measure the price growth of this cost
category. This is the same price proxy
used for the All Other Services cost
category in the 2017-based FQHC
market basket (85 FR 84709).
(n) Fixed Assets
We propose to use the PPI Industry
for Lessors of Nonresidential Buildings
(BLS series code PCU531120531120) to
measure the price growth of this cost
category (81 FR 80398). We believe this
continues to be the most appropriate
price proxy since fixed asset costs in
61803
FQHCs should reflect inflation for the
rental and purchase of business office
space. This is the same price proxy used
for the Fixed Assets cost category in the
2017-based FQHC market basket (85 FR
84709).
(o) Movable Equipment
We propose to continue to use the PPI
Commodities for Machinery and
Equipment (BLS series code WPU11) to
measure the price growth of this cost
category as this cost category represents
nonmedical movable equipment. This is
the same price proxy used for the
Movable Equipment cost category in the
2017-based FQHC market basket (85 FR
84709).
(2) Summary of Price Proxies of the
Proposed 2022-Based FQHC Market
Basket
Table 28 shows the cost categories
and associated price proxies for the
proposed 2022-based FQHC market
basket.
TABLE 28: Cost Categories and Price Proxies for the Proposed 2022-based FQHC Market
Basket
FQHC Practitioner Wa es and Salaries
FQHC Practitioner Em lo ee Benefits
Clinical StaffWa es and Salaries
Clinical Staff Em lo ee Benefits
Non-Health Staff Com ensation
Pharmaceuticals
Utilities
Medical E ui ment
Medical Su lies
Miscellaneous Products
Professional Scientific and Technical Services
ort Services
All Other Services
Fixed Assets
Movable ui ment
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Administrative and Facilities Su
ECI for Wages and Salaries for Private Industry Workers in Professional and
Related
ECI for Total Benefits for Private Industry Workers in Professional and
Related
ECI for Wages and Salaries for All Civilian Workers in Health Care and
Social Assistance
ECI for Total Benefits for All Civilian Workers in Health Care and Social
Assistance
ECI for Total Compensation for Private Industry Workers in Office and
Administrative Su ort
PPI S ecial Index for Pharmaceuticals for Human Use, Prescri tion
CPI-U for Fuels and Utilities
PPI Commodit •Index for Su ical and Medical Instruments
Composite: PPI Commodity Index for Medical and Surgical Appliances and
Su lies 50% and CPI for Medical E ui ment and Su lies 50%
CPI-U for All Items Less Food and Ener
ECI for Total compensation for Private industry workers in Professional,
Scientific, and Technical Services
ECI for Total Compensation for Private Industry Workers in Office and
Administrative Su ort
ECI for Total Compensation for Private Industry Workers in Service
Occu ations
61804
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
We are soliciting comments on our
proposal to rebase and revise the FQHC
market basket to reflect a 2022 base
year.
e. Proposed CY 2025 ProductivityAdjusted Market Basket Update for
FQHCs
For CY 2025 (that is, January 1, 2025,
through December 31, 2025), we
propose to use an estimate of the
proposed 2022-based FQHC market
basket to update payments to FQHCs
based on the best available data. We
propose to use the update based on the
most recent historical data available at
the time of publication of the final rule.
For example, the final CY 2025 FQHC
update would be based on the fourquarter moving-average percent change
of the proposed 2022-based FQHC
market basket through the second
quarter of 2024 (based on the final rule’s
statutory publication schedule). At the
time of this proposed rule, we do not
have the second quarter of 2024
historical data, and therefore, we
propose to use the most recent
projection available at the time.
Consistent with CMS practice, we
estimate the market basket update for
the FQHC PPS based on the most recent
forecast from IHS Global, Inc. (IGI). IGI
is a nationally recognized economic and
financial forecasting firm with which
CMS contracts to forecast the
components of the market baskets and
total factor productivity (TFP).
Based on IGI’s first quarter 2024
forecast with historical data through the
fourth quarter of 2023, the proposed
2022-based FQHC market basket
increase factor for CY 2025 is 4.0
percent. For comparison, the 2017-based
FQHC market basket percentage
increase is also projected to be 4.0
percent in CY 2025; this estimate is
based on IGI’s first quarter 2024 forecast
(with historical data through the fourth
quarter of 2023). Table 29 compares the
proposed 2022-based FQHC market
basket and the 2017-based FQHC market
basket annual percent changes from
2021 through 2028.
TABLE 29: Proposed 2022-Based FQHC Market Basket and 2017-Based FQHC Market
Basket Percent Changes, CYs 2021 through 2028
Over the historical update time period
covering CY 2021 through CY 2024, the
average growth rate of the proposed
2022-based FQHC market basket is the
same as the average growth rate of the
2017-based FQHC market basket. Over
the forecasted time period covering CY
2025 through CY 2028, the average
growth rate of the proposed 2022-based
FQHC market basket is also the same as
the average growth rate of the 2017based FQHC market basket. So, although
the compensation cost weights in the
proposed 2022-based FQHC market
basket is lower than in the 2017-based
FQHC market basket, and the weights
for other products and services is
higher, there is little impact on the
historical or projected FQHC market
basket percentage increase.
Section 1834(o)(2)(B)(ii) of the Act
describes the methods for determining
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updates to FQHC PPS payment. We
have included a productivity
adjustment to the FQHC PPS annual
payment update since implementation
of the FQHC PPS (81 FR 80393) and we
propose to continue to include a
productivity adjustment to the proposed
2022-based FQHC market basket. We
propose to use the most recent estimate
of the 10-year moving average of
changes in annual private nonfarm
business (economy-wide) total factor
productivity (TFP), which is the same
measure of TFP applied to other CMS
market basket updates including the
MEI. The U.S. Department of Labor’s
Bureau of Labor Statistics (BLS)
publishes the official measures of
productivity for the U.S. economy. We
note that previously the productivity
published by BLS was referred to as
multifactor productivity. Beginning
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with the November 18, 2021, release of
productivity data, BLS replaced the
term ‘‘multifactor productivity’’ (MFP)
with ‘‘TFP.’’ Please see https://
www.bls.gov/productivity/data.htm for
the BLS historical published TFP data.
For the final FQHC market basket
update, we propose to use the most
recent historical estimate of annual TFP
as published by the BLS. Generally, the
most recent historical TFP estimate is
lagged two years from the payment year.
Therefore, we propose to use the 10year moving average percent change in
annual private nonfarm business TFP
through 2023 as published by BLS in
the CY 2025 FQHC market basket
update. We note that TFP is derived by
subtracting the contribution of labor and
capital input growth from output
growth. Since at the time of
development of this proposed rule the
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Proposed
2022-Based FQHC Market Basket
2017-Based FQHC Market
Calendar Year
Index
Basket Index Percent
(CY) 1
Percent Chan2e
Chan2e
CY2021
2.4
2.4
CY2022
2.2
2.3
CY2023
4.3
4.3
Historical Data
CY2024
5.1
5.0
Avera2e 2021-2024
3.5
3.5
CY2025
4.0
4.0
CY2026
3.3
3.3
Forecast
CY2027
2.9
2.9
CY2028
2.8
2.9
Avera2e 2025-2028
3.3
3.3
1/ CY index percent changes are based on data through the 2nd quarter of the year prior to the update year.
Note that these market basket percent changes do not include any further adjustments as may be statutorily required.
Source: IHS Global Inc. 1st quarter 2024 forecast
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
measure of TFP for 2023 had not yet
been published by BLS, we propose to
use IGI’s first quarter 2024 forecast of
TFP. A complete description of IGI’s
TFP projection methodology is available
on the CMS website at https://
www.cms.gov/data-research/statisticstrends-and-reports/medicare-programrates-statistics/market-basket-researchand-information.
Using IGI’s first quarter 2024 forecast,
the productivity adjustment for CY 2025
(the 10-year moving average of TFP for
the period ending CY 2023) is projected
to be 0.5 percent. Therefore, the
proposed CY 2025 productivity-adjusted
proposed 2022-based FQHC market
basket update is 3.5 percent, based on
IGI’s first quarter 2024 forecast with
historical data through the fourth
quarter of 2023. This reflects a 4.0
percent increase in the proposed 2022based FQHC market basket reduced by
a 0.5 percentage point productivity
adjustment. Finally, we propose that the
CY 2025 market basket update and the
productivity adjustment will be updated
to reflect the most recent historical data
available for the final rule.
8. Clarification for Dental Services
Furnished in FQHCs
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a. Payment for Dental Services
Furnished in FQHCs
Section 1862(a)(12) of the Act
generally precludes payment under
Medicare Parts A or B for any expenses
incurred for services in connection with
the care, treatment, filling, removal, or
replacement of teeth or structures
directly supporting teeth. (Collectively
here, we will refer to ‘‘the care,
treatment, filling, removal, or
replacement of teeth or structures
directly supporting teeth’’ as ‘‘dental
services.’’) That section of the statute
also includes an exception to allow
payment to be made for inpatient
hospital services in connection with the
provision of such dental services if the
individual, because of their underlying
medical condition and clinical status or
because of the severity of the dental
procedure, requires hospitalization in
connection with the provision of such
services. Our regulation at 42 CFR
411.15(i) similarly excludes payment for
dental services except for inpatient
hospital services in connection with
dental services when hospitalization is
required because of: (1) the individual’s
underlying medical condition and
clinical status; or (2) the severity of the
dental procedure.
Fee for service (FFS) Medicare Parts A
and B also make payment for certain
dental services in circumstances where
the services are not considered to be in
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connection with dental services within
the meaning of section 1862(a)(12) of
the Act. In the CY 2023 PFS final rule
(87 FR 69663 through 69688), we
clarified and codified at § 411.15(i)(3)
that Medicare payment under Parts A
and B could be made when dental
services are furnished in either the
inpatient or outpatient setting when the
dental services are inextricably linked
to, and substantially related and integral
to the clinical success of, other covered
services. We also added several
examples of clinical scenarios that are
considered to meet that standard under
§ 411.15(i)(3) and amended that
regulation to add more examples in the
CY 2024 PFS final rule (88 FR 79022
through 79029).
In the CY 2024 PFS final rule (88 FR
79038), we received comments
requesting we provide payment for
inextricably linked dental services in
the FQHC setting. Commenters stated
that it is critical that CMS consider
FQHCs’ unique Medicare payment
structure and that CMS ensure that
policy changes for FQHCs are analogous
to any changes made under the PFS.
Commenters noted that many FQHCs
provide dental services on-site, and
health center patients could benefit
from the payment policies for dental
services inextricably linked to other
covered services and suggested that the
FQHC billing codes should be edited in
tandem. Commenters further noted that
‘‘physicians’ services’’ component of the
Medicare FQHC benefit includes
services furnished by dentists. Several
commenters urged that the list of
billable dental visit codes modified in
the proposed rule be added to the list of
codes that may be billed in the FQHC
setting and requested that any
expansion in codes recognized under
the PFS for dental-related services also
be applied to FQHCs. We acknowledged
the commenters concerns and noted our
intention to modify operational
procedures in the FQHC setting to
reflect the expansion of this PFS policy,
including updates to billable code lists.
We agree that RHC and FQHC
Medicare beneficiaries could benefit
from the payment policies established
under the PFS for dental services that
are inextricably linked to specific
medical services. Dentists are defined as
physicians in Medicare statute (42 CFR
491.2). Services furnished by physicians
are billable visits in RHCs and FQHCs
and they could bill for a face-to-face,
medically necessary visit furnished by a
dentist within their scope of practice.
Therefore, we are clarifying in this
proposed rule that dental services
exactly as described in section II.J and
furnished in an RHC or FQHC are RHC
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61805
and FQHC visits and as such can be
paid under the RHC AIR methodology
or FQHC PPS.
We would apply and operationalize
the dental policies finalized in the CY
2023 and 2024 PFS final rules as
applicable also to RHCs and FQHCs and
update the FQHC qualifying visit list as
appropriate. Consistent with the
discussion in section II.J of this
proposed rule, if an RHC or FQHC
practitioner believes the dental services
for which they submit Medicare claims
are inextricably linked to a covered
service, a modifier may be reported on
an RHC or FQHC claim for payment
purposes. The KX modifier is reported
on an RHC or FQHC claim to indicate
that the service is medically necessary,
and that the provider has included
appropriate documentation in the
medical record to support or justify the
medical necessity of the service or item.
We believe that usage of the KX
modifier in the context of claims for
dental services inextricably linked to
covered services to indicate that the
clinician attests that the service is
medically necessary, and that the
provider has included appropriate
documentation is appropriate and will
support claims processing and program
integrity efforts.
We are clarifying that when RHCs and
FQHCs furnish dental services that align
with the policies and operational
requirements in the physician setting,
we would consider those services to be
a qualifying visit and the RHC would be
paid at the RHC AIR methodology and
the FQHC would be paid under the
FQHC PPS.
b. Medical and Dental Visits Furnished
on the Same Day
If an RHC or FQHC patient has a
medically-necessary face-to-face visit
with an RHC or FQHC practitioner, and
is then seen by another RHC or FQHC
practitioner, including a specialist, for
further evaluation of the same condition
on the same day, or is then seen by
another RHC or FQHC practitioner,
including a specialist, for evaluation of
a different condition on the same day,
the multiple encounters would
constitute a single RHC or FQHC visit
and be payable as one visit regardless of
the length or complexity of the visit,
whether the second visit is a scheduled
or unscheduled appointment, or
whether the first visit is related or
unrelated to the subsequent visit.
If the RHC or FQHC patient suffers an
illness or injury that requires additional
diagnosis or treatment on the same day
subsequent to the first visit, or has a
medical and a mental health visit on the
same day, or an RHC patient has an
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Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
initial preventive physical exam (IPPE)
and a separate medical and/or mental
health visit on the same day, then the
RHC or FQHC would be paid separately
for each visit.
We are seeking comment on whether
the multiple visits policy should apply
to patients who have an encounter with
an RHC or FQHC practitioner and a
dentist on the same day or should a
subsequent encounter with a dentist be
considered an exception to this policy
and be paid as a separate billable visit.
We are interested in understanding
when these situations could occur.
9. ‘‘Grandfathered’’ Technical
Refinement
a. Background
We have conducted a review of our
regulations and guidance to determine
where preferred terms may be used. We
found several sections in part 405,
subpart X, that use the term
‘‘grandfathered.’’ For example, in
§ 405.2462(f)(1) a ‘‘grandfathered tribal
FQHC’’ is a FQHC that is operated by a
tribe or tribal organization under the
Indian Self-Determination and
Education Assistance Act (ISDEAA);
was billing as if it were provider-based
to an IHS hospital on or before April 7,
2000, and is not currently operating as
a provider-based department of an IHS
hospital.
b. Technical Refinement
We believe language in
communication products should reflect
and speak to the needs of people in the
audience of focus. In an effort to
represent an ongoing shift to nonstigmatizing language, we are proposing
to make a technical change to remove
the term ‘‘grandfathered’’ from the
regulation text in §§ 405.2462, 405.2463,
405.2464, and 405.2469 and replace it
with ‘‘historically excepted’’ to describe
a level of protection provided to certain
tribal FQHCs that predates applicable
restrictions.
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C. Rural Health Clinic (RHC) and
Federally Qualified Health Center
(FQHC) Conditions for Certification and
Conditions for Coverage (CfCs)
1. Background and Statutory Authority
The Rural Health Clinic Services Act
of 1977 (Pub. L. 95–210 enacted
December 13, 1977) amended the Social
Security Act (the Act) by enacting
section 1861(aa) to extend Medicare and
Medicaid entitlement and payment for
outpatient services and emergency care
services furnished at a rural health
clinic (RHC) by physicians and certain
other practitioners, and for services and
supplies incidental to their services.
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Other practitioners include nurse
practitioners and physician assistants,
and subsequent legislation extended the
definition of covered RHC services to
include the services of clinical
psychologists, clinical social workers,
certified nurse midwives, marriage and
family therapists, and mental health
counselors.
We have broad statutory authority to
establish health and safety standards for
most Medicare and Medicaid
participating provider and supplier
types. Section 1861(aa) of the Act
authorizes the Secretary to establish the
requirements that an RHC and Federally
Qualified Health Center (FQHC) must
meet to participate in the Medicare
Program. As required by subparagraph
(iv) of the flush material set out after
section 1861(aa)(2)(K) of the Act,
Medicare certified RHCs must not be a
rehabilitation agency or a facility which
is primarily for the care or treatment of
mental diseases. These statutory CfC
requirements are codified in regulations
at 42 CFR part 491. RHCs and FQHCs
must meet these requirements to receive
Medicare payment for services. These
regulations are intended to protect the
health and safety of patients receiving
care from these facilities. We note that
there are approximately 5,462 Medicarecertified RHCs and 11,853 Medicarecertified FQHCs.
In this proposed rule, we also aim to
ensure RHCs are provided flexibility in
the services they offer, including
specialty and laboratory services.
2. Proposed Changes to the RHC and
FQHC Conditions for Certification and
Conditions for Coverage (CfCs)
a. Provision of Services (42 CFR 491.9)
In accordance with section 1861(aa) of
the Act, § 491.9, Provision of services,
establishes the basic requirements for
services RHCs and FQHCs must provide
in accordance with applicable Federal,
State, and local laws. This CfC also
outlines patient care policies, including
the development of written policies and
the establishment of guidelines for
medical management, record-keeping,
and drug administration. Additionally,
this section specifies the diagnostic,
therapeutic, laboratory, and emergency
services that RHCs and FQHCs must
offer, as well as the necessary
agreements or arrangements with other
healthcare providers to furnish
additional services not available onsite.
RHCs and FQHCs play a crucial role
in providing accessible and
comprehensive healthcare services in
underserved areas, often serving as the
primary point of contact for healthcare
services for residents living in these
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communities. Approximately 20 percent
of the U.S. population lives in rural
areas.312 When compared to their urban
counterparts, rural residents are more
likely to be living in poverty, unhealthy,
older adults, uninsured or
underinsured, and medically
underserved.313 Accounting for the
unique circumstances of individuals
living in rural areas and the broad array
of services RHCs and FQHCs provide to
their communities, it is imperative to
support rural facilities so they may
continue to provide healthcare services
to medically underserved populations.
Research shows that accessing
primary care is associated with positive
health outcomes.314 Individuals who
receive primary care services are more
likely to receive preventive care, which
results in lower rates of illness and
premature death.315 Furthermore,
without access to primary care services,
an individual may delay seeking
treatment until their illness has
worsened. In such cases, they may end
up receiving care in the emergency
department, which costs more and leads
to poorer health outcomes.316 317 318
Rural residents also report difficulty
accessing specialty care due to having to
travel considerable distances,
exacerbated by rural hospitals closing
312 U.S. Census Bureau. (2023, March 10).
Nation’s Urban and Rural Populations Shift
Following 2020 Census. U.S. Department of
Commerce. Retrieved April 12, 2024, from https://
www.census.gov/newsroom/press-releases/2022/
urban-rural-populations.html.
313 Report to the Congress: Medicare and the
Health Care Delivery System (June 2012)
(medpac.gov). Medicare Payment Advisory
Commission. (2012, June). Medicare and the Health
Care Delivery System. https://www.medpac.gov/wpcontent/uploads/import_data/scrape_files/docs/
default-source/reports/jun12_entirereport.pdf.
314 Shi L. (2012). The impact of primary care: a
focused review. Scientifica, 2012, 432892. https://
doi.org/10.6064/2012/432892.
315 Hostetter, J., Schwarz, N., Klug, M., Wynne, J.,
& Basson, M. D. (2020). Primary care visits increase
utilization of evidence-based preventative health
measures. BMC family practice, 21(1), 151. https://
doi.org/10.1186/s12875-020-01216-8.
316 Tang, N., Stein, J., Hsia, R. Y., Maselli, J. H.,
& Gonzales, R. (2010). Trends and characteristics of
US emergency department visits, 1997–2007. JAMA,
304(6), 664–670. https://doi.org/10.1001/
jama.2010.1112.
317 Gallagher, A., Liu, J., Probst, J. C., Martin, A.
B., & Hall, J. W. (2013). Maternal obesity and
gestational weight gain in rural versus urban
dwelling women in South Carolina. The Journal of
rural health: official journal of the American Rural
Health Association and the National Rural Health
Care Association, 29(1), 1–11. https://doi.org/
10.1111/j.1748-0361.2012.00421.x.
318 Bailey, B. A., & Cole, L. K. (2009). Rurality and
birth outcomes: findings from southern appalachia
and the potential role of pregnancy smoking. The
Journal of rural health: official journal of the
American Rural Health Association and the
National Rural Health Care Association, 25(2), 141–
149. https://doi.org/10.1111/j.17480361.2009.00210.x
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and provider shortages.319 320 RHC
practitioners have also reported
additional barriers to receiving
specialized care, which include a
shortage of specialty providers, limited
availability of the specialty providers,
lack of transportation, and not accepting
patients who are uninsured or
specialists not accepting insurance
coverage (Medicare, Medicaid, or
private insurance).321
Based on feedback from interested
parties, including RHC providers and
rural health associations, we identified
a discrepancy in the guidance, statute,
and regulations. Specifically, interested
parties questioned the language in the
CMS State Operations Manual RHC
interpretative guidance as it relates to
§ 491.9(a)(2), which states that ‘‘RHCs
may not be primarily engaged in
specialized services.’’ 322 The guidance
goes on to state that, in this context,
‘‘primarily engaged’’ is determined by
considering the total hours of an RHC’s
operation and whether a majority, i.e.,
more than 50 percent, of those hours
involve the provision of RHC services,
whereas section 1861(aa)(2)(A) of the
Act only reference being primarily
engaged in ‘‘furnishing to outpatients’’
physician services and services
furnished by a physician assistant or a
nurse practitioner, clinical psychologist
or by a clinical social worker, as crossreferenced by sections 1861(aa)(1)(A)
and (B) of the Act. This is codified in
the CfCs at § 491.9(a)(2), requiring RHCs
and FQHCs to be primarily engaged in
‘‘providing outpatient health services.’’
We have enforced a standard requiring
that RHCs be primarily engaged in
providing primary care services based
on the interpretive guidance.
To clarify the requirements and intent
of the program regarding the services
provided by RHCs and FQHCs, we are
319 Akinlotan, M., Primm, K., Khodakarami, N.,
Bolin, J., Ferdinand, A. (2021). Rural-Urban
Variations in Travel Burdens for Care: Findings
from the 2017 National Household Travel Survey
[Policy brief]. Southwest Rural Health Research
Center. https://srhrc.tamu.edu/publications/travelburdens-07.2021.pdf.
320 Douthit, N., Kiv, S., Dwolatzky, T., & Biswas,
S. (2015). Exposing some important barriers to
health care access in the Rural USA. Public Health,
129(6), 611–620. https://doi.org/10.1016/
j.puhe.2015.04.001.
321 Lahr, M., Neprash, H., Henning-Smith, C.,
Tuttle, M., Hernandez, A. (2019). Access to
Specialty Care for Medicare Beneficiaries in Rural
Communities [Policy brief]. University of Minnesota
Rural Health Research Center. https://
rhrc.umn.edu/wp-content/uploads/2019/12/UMNAccess-to-Specialty-Care_12.4.pdf.
322 Centers for Medicare & Medicaid Services.
(2020, February 21). State Operations Manual
Appendix G—Guidance for Surveyors: Rural Health
Clinics (RHCs) (pp. 63–64). https://www.cms.gov/
Regulations-and-Guidance/Guidance/Manuals/
downloads/som107ap_g_rhc.pdf.
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proposing changes to the Provision of
services CfCs. We also aim to ensure
RHCs are provided flexibility in the
services they offer, including specialty
services. To align the requirements and
preserve access to primary care services
in rural areas, we are proposing to add
standards to § 491.9(a)(2) explicitly
requiring RHCs and FQHCs to provide
primary care services (at § 491.9(a)(2)(i))
and explicitly noting that RHCs cannot
be a rehabilitation agency or a facility
which is primarily for the care and
treatment of mental diseases (at
§ 491.9(a)(2)(ii)). Under our proposal,
RHCs and FQHCs would continue to be
required to provide primary care
services to their patient populations, but
CMS would no longer determine or
enforce the standard of RHCs ‘‘being
primarily engaged in furnishing primary
care services’’ and would no longer
consider the total hours of an RHC’s
operation and whether a majority, that
is, more than 50 percent, of those hours
involve primary care services through
the survey process. These proposed
requirements, as well as the subsequent
proposal discussed in section III.C.2.b.
of this proposed rule, will be enforced
in accordance with section 1864 of the
Act, which requires that CMS use state
surveyors to determine whether a
provider or supplier subject to
certification qualifies for an agreement
to participate in Medicare. However,
under section 1865 of the Act, providers
and suppliers subject to certification
may instead elect to be accredited by
private accrediting organizations whose
Medicare accreditation programs have
been approved by CMS as having
standards and survey procedures that
meet or exceed all applicable Medicare
requirements.
This proposal would allow RHCs to
provide more outpatient-specialty
services within the practitioner’s scope
of practice to meet the needs of the
patient population—for example,
internal medicine, pediatrics, geriatrics,
obstetrics and gynecology, dermatology,
cardiology, neurology, endocrinology,
and ear, nose and throat. Section
1861(aa) of the Act does not explicitly
state that RHCs must provide primary
care services, though we believe this is
the intended purpose of the statute.
Clause (i) of the second sentence of the
flush material after section
1861(aa)(2)(K) of the Act, requires RHCs
to be located in an area designated as
either an area with a shortage of
personal health services under section
330(b)(3) or 1302(7) of the Public Health
Service Act or as a health professional
shortage area described in section
332(a)(1)(A) of that Act because of its
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shortage of primary medical care
manpower. Additionally, we use the
phrase ‘‘the entry point into the health
care system’’ in the RHC and FQHC
CfCs at § 491.9(c)(1). We note that this
language is consistent with language
used in the Rural Emergency Hospital
Conditions of Participation (CoPs) under
the requirement for Additional
outpatient medical and health services
(§ 485.524(a)), and the Critical Access
Hospital CoPs under the requirement for
Provision of services (§ 485.635(b)(1)(i)).
The American Academy of Family
Physicians (AAFP) defines primary care
practice as ‘‘A primary care practice
serves as the patient’s entry point into
the health care system and as the
continuing focal point for all needed
health care services.’’ Therefore, we
expect RHCs and FQHCs to offer a range
of primary health care services to ensure
that patients receive the necessary care
at the earliest possible point of contact.
Primary care services are critical in
promoting health, preventing illness,
and managing chronic conditions.323
This proposal also provides
clarification regarding the requirement
that RHCs cannot be a rehabilitation
agency or a facility which is primarily
for the care and treatment of mental
diseases. While this requirement is
included under § 491.2, Definitions—
Rural health clinic or clinic, including
this requirement under the Provision of
services CfC at § 491.9(a)(2)(ii) as a
separate standard more clearly cites the
requirement and allows for a clearer
evaluation of compliance with the
specific requirement. CMS defines a
rehabilitation agency as ‘‘[a]n agency
that provides an integrated,
multidisciplinary program designed to
upgrade the physical functions of
handicapped, disabled individuals by
bringing together, as a team, specialized
rehabilitation personnel.’’324
Rehabilitation services may include
physical therapy, occupational therapy,
and speech-language pathology services.
CMS acknowledges that the term
‘‘mental diseases’’ is outdated and not
often used in the field of mental health
today. This term can cause stigma
against people with mental health
conditions and can be a major barrier to
seeking help or treatment and can be a
cause of reduced likelihood of engaging
323 Primary Care. (n.d.). https://www.cms.gov/
priorities/innovation/key-concepts/primary-care.
324 Centers for Medicare & Medicaid Services.
(2023, September 6). Outpatient Rehabilitation
Providers. CMS.gov. https://www.cms.gov/
medicare/health-safety-standards/certificationcompliance/outpatient-rehabilitationproviders#:∼:text=Rehabilitation%20Agency
%20%2D%20An%20agency
%20that,a%20team%2C%20specialized
%20rehabilitation%20personnel.
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in ongoing treatment. As discussed in
section III.C.1 of this proposed rule, the
U.S. Congress passed Public Law 95–
210 (enacted December 13, 1977) that
established criteria for the establishment
of Medicare-certified RHCs and has
included the term ‘‘mental diseases’’
since that time. As we are bound by the
current statutory requirements, we have
included the term in the RHC CfCs as it
appears in the statute. We note that the
statute is enacted by Congress and it
would take an Act of Congress to make
statutory changes.
For the purpose of this proposed rule,
the term ‘‘mental diseases’’ refers to
behavioral health conditions (that is,
mental and substance use disorders). As
part of the Coverage to Care (C2C)
initiative, CMS published the Roadmap
to Behavioral Health, which defines
behavioral health conditions to include
mental and substance use disorders.325
The guide defines mental disorders as
changes in a person’s thinking, mood,
and/or behavior and can only be
diagnosed based on the person’s ability
to function as a result of their
symptoms. The guide defines
‘‘substance use disorder’’ as when a
person’s repeated use of alcohol and/or
drugs causes clinically significant
impairment.326 This may include health
problems, disability, and failure to meet
major responsibilities at home, school,
or work.
These proposed changes to the RHC
CfCs should not be construed as CMS
prohibiting or discouraging the
provision of RHC specialty services or
behavioral health services. An RHC or
FQHC may offer such specialty services
and behavioral health services to its
patients in addition to the primary care
services it already provides. However,
RHCs cannot be a rehabilitation agency
or a facility, which is primarily for the
care and treatment of mental diseases.
As noted, the term ‘‘mental diseases’’ is
outdated; therefore, this proposed rule
aims to define ‘‘mental diseases’’ for the
purpose of the RHC and FQHC health
and safety standards and future
guidance will clarify how CMS will
determine whether an RHC is primarily
providing care and treatment of mental
diseases. CMS would assess a facility’s
compliance with this proposed
requirement based on policies
325 Centers for Medicare & Medicaid Services, and
the Substance Abuse and Mental Health Services
Administration. (2023, October). Roadmap to
Behavioral Health: Guide to Mental Health and
Substance Use Disorder Services. https://
www.cms.gov/files/document/roadmap-behavioralhealth-english.pdf.
326 SAMHSA. (2023, June 09). Mental Health and
Substance Use Disorders. Retrieved June 17, 2024,
from https://www.samhsa.gov/find-help/disorders.
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published in subsequent interpretative
guidance, which we would publish if
this revision is adopted in a final rule.
As we continue to focus on improved
access to care for the rural communities
served by RHCs, and to ensure that the
proposed provisions do not have
unintended consequences, we are
soliciting public comment on the
following questions to gain insight on
the anticipated impact of this proposed
policy on access to primary care
services, behavioral health services, and
specialty care services:
• What types of behavioral health
services are currently offered by RHCs
(that is, therapy, counseling, medication
management, substance use disorder
treatment, etc.), and how often are these
services provided?
• For those RHCs that are currently
providing behavioral health services,
who provides those services (that is,
physician, psychologist, social worker,
marriage and family therapist, or mental
health counselor)? What is the clinic’s
capacity to accept new behavioral
health patients? What potential impacts
do you anticipate for RHCs and the
community if they were able to provide
more behavioral health services? How
would these impacts be addressed?
• Are there specific behavioral health
conditions that your clinic is better
equipped to treat than others, and if so,
what are those behavioral health
conditions?
• For those RHCs that are not
currently providing behavioral health
services, what barriers or challenges
does the RHC face that limit the ability
to furnish behavioral health services
(that is, geographic location,
transportation issues, service area size,
staffing issues, stigma, regulatory or
survey concerns)?
• What standards or criteria should
surveyors use to evaluate whether a
RHC is operating as a ‘‘facility which is
primarily for the care and treatment of
mental diseases’’?
b. Laboratory Requirements (42 CFR
491.9)
Section 1861(aa)(2)(G) of the Act
requires RHCs to provide routine
diagnostic services directly (that is, they
must be furnished at the RHC, by RHC
personnel), including clinical laboratory
services. We have implemented this
statutory provision through regulations
at § 491.9(c)(2), which require RHCs to
provide six specific diagnostic
laboratory tests directly; chemical
examinations of urine by stick or tablet
method or both (including urine
ketones); hemoglobin or hematocrit;
blood glucose; examination of stool
specimens for occult blood; pregnancy
tests; and primary culturing for
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transmittal to a certified laboratory. This
list reflects the same tests that have been
required since RHCs were established in
1978 (43 FR 30529) and were chosen
because they were commonly performed
in physicians’ offices at that time.
The Clinical Laboratory Improvement
Amendments of 1988 (CLIA) (Pub. L.
100–578), revised section 353 of the
Public Health Service Act to require all
clinical laboratories that test human
specimens for health purposes to meet
certain requirements. CLIA requires that
the complexity of tests and the skill in
interpreting results determine the extent
of supervision and review. Tests are
categorized from ‘‘waived’’ (those
needing minimal supervision) to ‘‘high
complexity’’ (those requiring the highest
level of supervision and review).
Regulations implementing CLIA are
contained in 42 CFR part 493. Under
these regulations, laboratories
performing specified tests categorized as
waived, physician-performed
microscopy moderate or high
complexity must obtain a certificate that
shows they meet specific standards. All
tests RHCs are required to perform are
classified as waived under CLIA, as
published in the 1992 Federal Register
and listed at 42 CFR 493.15(c).
We are proposing to remove
hemoglobin and hematocrit (H&H) from
the listed laboratory services in
§ 491.9(c)(2) that RHCs must perform
directly. In addition, we are proposing
to revise paragraph (c)(2)(vi) to reflect
current practice for microbiology
specimens. Interested parties have
expressed concerns with the existing
laboratory requirements, citing the
financial and physical burdens
associated with maintaining the lab
equipment that is used for laboratory
tests that are ordered infrequently for
patients receiving services at the RHC.
RHC providers have reported that the
H&H laboratory test in particular is
overly burdensome. We are therefore
proposing to remove the H&H laboratory
test from the list of required laboratory
tests to increase flexibility in the
services offered by RHCs.
A hemoglobin test evaluates the
amount of hemoglobin in the blood,
which is responsible for carrying oxygen
to a person’s organs and tissues and
transporting carbon dioxide back to the
lungs.327 Hematocrit is the percentage of
red blood cells in a person’s blood and
is tested to evaluate red blood cells.328
327 Hemoglobin test: What it is, procedure &
results. Hemoglobin Test. (n.d.). Retrieved May 7,
2024, from https://my.clevelandclinic.org/health/
diagnostics/17790-hemoglobin-test.
328 Hematocrit test: What it is, levels, high & low
range. Hematocrit Test. (n.d.). Retrieved May 7,
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Doctors test hemoglobin and hematocrit
levels to evaluate overall health,
diagnose a medical condition, or
monitor an existing medical condition.
While RHCs are currently required to
have and maintain the equipment and
supplies for these tests onsite, H&H
blood tests are typically performed as
part of a comprehensive blood count
(CBC) and are not ordered separately in
accordance with current clinical
standards of practice. RHCs report that
when laboratory tests are ordered that
are not provided by the RHC, such as a
CBC, their patients are often sent to the
nearest hospital that would have a fullservice laboratory available to perform
the test. As a result, some RHCs located
near hospitals may not be utilizing their
laboratory equipment and supplies, or
they may be utilizing them on a limited
basis. This is because when laboratory
tests are ordered by the RHC, and the
order includes hemoglobin and
hematocrit, and other tests that are not
provided by the RHC, the patient will
receive all of their ordered laboratory
tests at the nearby hospital.
Additionally, removing the requirement
for these tests to be performed at the
RHC limits the number of venipunctures
the patient must experience.
In 2021, 66 percent of all RHCs were
designated as provider-based RHCs,
meaning they are owned and operated
as an integral part of a hospital, nursing
home, or home health agency.329
Provider-based RHCs are governed,
supervised, and licensed by the parent
organization, and most provider-based
RHCs are hospital-owned. The
remaining 34 percent of RHCs are
independent clinics owned by a
healthcare provider or entity and though
not as common, may be owned and/or
operated by a healthcare system.
Therefore, we believe a large majority of
provider-based—and some
independent—RHCs have access to a
full-service laboratory, thereby
maintaining access to the H&H
laboratory test, even if it is no longer
required to be provided directly by
RHCs.
We have also received feedback that
the current requirement at
§ 491.9(c)(2)(vi) does not reflect current
clinical laboratory standards of practice
and laboratory techniques. This
2024, from https://my.clevelandclinic.org/health/
diagnostics/17683-hematocrit.
329 Gale, J. A., Croll, Z., Croom, J., Munk, L., &
Jonk, Y. (2022). Community Characteristics and
Financial and Operational Performance of Rural
Health Clinics in the United States: A Chartbook.
University of Southern Maine, Muskie School of
Public Service, Maine Rural Health Research
Center. https://digitalcommons.usm.maine.edu/cgi/
viewcontent.cgi?article=1016&context=clinics.
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standard currently lists the laboratory
services that must be provided by RHCs,
with the list specifically including
‘‘primary culturing for transmittal to a
certified laboratory.’’ Primary culturing
is an outdated microbiology practice
that is no longer performed due to
modern lab techniques. Instead, RHCs
collect specimens using appropriate
collection and storage techniques and
send them to a certified laboratory
without initial culturing. Therefore, we
are proposing to update the language in
this standard such that the laboratory
services RHCs would be required to
provide include the ‘‘collection of
patient specimens for transmittal to a
certified laboratory for culturing.’’ This
proposal, along with the proposal
removing the H&H from the list of
required labs, would require that an
RHC provide the remaining following
laboratory services at § 491.9(c)(2): (1)
chemical examinations of urine by stick
or tablet methods or both (including
urine ketones); (2) blood glucose; (3)
examination of stool specimens for
occult blood; (4) pregnancy tests; and (5)
collection of patient specimens for
transmittal to a certified laboratory for
culturing. RHCs would still be required
under § 491.9(d)(1)(iii) to provide
prompt access to a Medicare or
Medicaid participating provider or
supplier that can furnish an H&H
laboratory test and any additional and
specialized diagnostic and laboratory
services the RHC is not equipped to
perform.
This proposal does not prevent RHCs
from providing tests not listed in
§ 491.9. An RHC is free to provide tests
consistent with its CLIA certification
and can choose a higher level CLIA
certification than the certificate of
waiver if it wishes to provide tests of
higher complexity and comply with all
CLIA requirements.
Little information on RHC laboratory
utilization is available, so while we are
proposing to remove the H&H laboratory
test from the list of diagnostic services
RHCs are required to provide, we solicit
public comment on how this may
impact access to H&H laboratory tests in
rural areas. We also are soliciting
comments on data, evidence, and
experience related to laboratory services
in RHCs and alternative basic lab
services that would be appropriate for
RHCs to provide to meet the needs of
underserved rural communities.
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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. A final rule
entitled ‘‘Medicare Clinical Diagnostic
Laboratory Tests Payment System’’
(CLFS final rule), which appeared in the
Federal Register on June 23, 2016 (81
FR 41036), 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.330
330 https://www.cms.gov/Medicare/Medicare-Feefor-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 § 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 § 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
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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
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, which implemented
section 1834A of the Act as required by
PAMA (81 FR 41036 through 41101),
and this information is also available on
the CMS website.331
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) 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
331 https://www.cms.gov/medicare/payment/feeschedules/clinical-laboratory-fee-schedule-clfs/
pama-educational-resources.
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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 ratebased 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
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
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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
§ 414.502.
Section 4 of PMAFSCA further
amended the provisions in section
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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.
Section 4114 of the Consolidated
Appropriations Act, 2023 (CAA, 2023)
(Pub. L. 117–328, December 29, 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 1 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. 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 did
not modify the data collection period
that applies to the next data reporting
period for CDLTs. Thus, under section
1834A(a)(4)(B) of the Act, the next data
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reporting period for CDLTs that are not
ADLTs (January 1, 2024, through March
31, 2024) would continue to be based on
the data collection period of January 1,
2019, through June 30, 2019, as reflected
in the definitions of data collection
period and data reporting period at
§ 414.502.
Section 4114(a) of the CAA, 2023
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 2026. It further
amended 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 amended 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,
instead of CYs 2023 through 2025. In
the CY 2024 PFS rulemaking (88 FR
79083 through 79087; 88 FR 79531), in
accordance with section 4114 of the
CAA, 2023, we proposed and finalized
conforming changes to the data
reporting and payment requirements at
42 CFR part 414, subpart G.
4. Additional Statutory Revisions to the
Data Reporting Period and Phase-In of
Payment Reductions
On November 17, 2023, section 502 of
the Further Continuing Appropriations
and Other Extensions Act, 2024 (Pub. L.
118–22) (FCAOEA, 2024) was passed
and delayed data reporting requirements
for CDLTs that are not ADLTs, and it
also delayed the phase-in of payment
reductions under the CLFS from private
payor rate implementation under
section 1834A of the Act. Specifically,
section 502(b) of the FCAOEA, 2024
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, 2025, through
March 31, 2025, instead of the data
reporting period of January 1, 2024,
through March 31, 2024. The 3-year data
reporting cycle for CDLTs that are not
ADLTs would resume after that data
reporting period. As amended by
section 502(b) of the FCAOEA, 2024,
section 1834A(a)(1)(B) of the Act now
provides that in the case of reporting
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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, 2024; (ii) reporting is required
during the period beginning January 1,
2025, and ending March 31, 2025; and
(iii) reporting is required every 3 years
after the period described in clause (ii).
Section 502 of the FCAOEA, 2024
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,
the next data reporting period for CDLTs
that are not ADLTs (January 1, 2025,
through March 31, 2025) will continue
to be based on the data collection period
of January 1, 2019, through June 30,
2019, as reflected in the definitions of
data collection period and data
reporting period at § 414.502.
Section 502(a) of the FCAOEA, 2024
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 2027. It further
amends section 1834A(b)(3)(B)(ii) of the
Act to specify that the applicable
percent for CY 2024 is 0 percent,
meaning that the payment amount
determined for a CDLT for CY 2024
shall not result in any reduction in
payment as compared to the payment
amount for that test for CY 2023.
Section 502(a) of the FCAOEA, 2024
further amends section
1834A(b)(3)(B)(iii) of the Act to state
that the applicable percent of 15 percent
will apply for CYs 2025 through 2027.
As a result of the statutory revisions
under the FCAA, CARES Act,
PMAFSCA, the CAA, 2023, and the
FCAOEA, 2024, 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.
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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 after PAMA
implementation, whereby payment
cannot exceed 15 percent per year as
compared to the amount established the
prior year, has not yet occurred.
5. Proposed Conforming Regulatory
Changes
In accordance with section 502 of the
FCAOEA, 2024, we are proposing to
make conforming changes to the data
reporting and payment requirements at
42 CFR part 414, subpart G. Specifically,
we are proposing to revise the
definitions of both the ‘‘data collection
period’’ and ‘‘data reporting period’’ at
§ 414.502 to specify that for the data
reporting period of January 1, 2025,
through March 31, 2025, 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 2025. 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
502(a) of the FCAOEA, 2024.
Specifically, we are proposing to revise
§ 414.507(d) to indicate that for CY
2024, payment may not be reduced by
more than 0.0 percent as compared to
the amount established for CY 2023, and
for CYs 2025 through 2027, 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 2024 and 2025
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
2026 through CY 2028 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, 2025,
through March 31, 2025.
E. Medicare Diabetes Prevention
Program (MDPP)
The Centers for Medicare & Medicaid
Services’ (CMS) Medicare Diabetes
Prevention Program Expanded Model
(hereafter, ‘‘MDPP’’ or ‘‘MDPP expanded
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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)
model test, which was initially tested by
CMS through a Round One Health Care
Innovation Award (2012–2016).332
MDPP was established in 2017 as an
‘‘additional preventive service,’’ 333
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 tested by The CMS
Innovation Center), CMS created a new
MDPP supplier type through rulemaking
in the CY 2017 PFS final rule (81 FR
80471), in addition to requiring
organizations that wish to participate in
MDPP to enroll in Medicare separately,
even if they are already enrolled in
Medicare for other purposes.
MDPP is a non-pharmacological
behavioral intervention consisting of up
to 22 intensive sessions 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. MDPP sessions
must be one hour in length and adhere
to a Centers for Disease Control and
Prevention (CDC) approved National
Diabetes Prevention Recognition
Program (National DPP) curriculum.334
The primary goal of the MDPP
expanded model is to help Medicare
beneficiaries reduce their risk for
developing type 2 diabetes by achieving
at least 5 percent weight loss from the
first core session (81 FR 80465).
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. As of May 13, 2024, there
332 The Health Care Innovation Awards funds
awards to organizations that implemented the most
compelling new ideas to deliver better health,
improved care, and lower costs to people enrolled
in Medicare, Medicaid and Children’s Health
Insurance Program (CHIP), particularly those with
the highest health care needs. The CMS Innovation
Center announced the first batch of awardees for the
Health Care Innovation Awards on May 8, 2012,
and the second (final) batch on June 15, 2012. For
more, see https://www.cms.gov/priorities/
innovation/innovation-models/health-careinnovation-awards.
333 42 CFR 410.64—Additional preventive
services.
334 https://www.cdc.gov/diabetes/prevention/
resources/curriculum.html.
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were 301 approved MDPP suppliers.335
The most recent MDPP evaluation
report, reflected that between April
2018 and December 31, 2021, 4,848
Medicare beneficiaries participated in
MDPP, including 2,325 FFS
beneficiaries and 2,523 MA
beneficiaries.336 Through the Diabetes
Prevention Recognition Program
(DPRP), CDC administers a national
quality assurance program recognizing
eligible organizations that furnish the
National DPP through its evidence
based DPRP Standards,337 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,338 the CDC’s
National DPP,339 and DPRP
Standards,340 please refer to the CY
2017 (81 FR 80471) and CY 2018 PFS
(82 FR 52976) final rules and related
websites.
The Public Health Emergency (PHE)
for COVID–19 prompted changes to
allow virtual delivery of the MDPP,
among other changes (85 FR 84830
through 84841). Changes to MDPP in the
CY 2024 PFS final rule (88 FR 78818)
included a simplified payment structure
to allow for fee-for-service (FFS)
payments for beneficiary attendance
while retaining the performance-based
payments for diabetes risk reduction
(that is, weight loss). Beginning January
1, 2024, payments are made to an MDPP
supplier if an MDPP beneficiary attends
any core session in the first 6 months or
core maintenance session in the second
6 months, allowing payment for up to
22 sessions in a 12-month timeframe.
The CY 2024 PFS final rule also
extended certain PHE flexibilities,
including the option to deliver some or
all MDPP sessions via distance learning
and for beneficiaries to virtually selfreport weight for MDPP distance
335 Medicare Provider Enrollment, Chain, and
Ownership System (PECOS). Unpublished data.
336 RTI International. Evaluation of the Medicare
Diabetes Prevention Program. November 2022.
https://www.cms.gov/priorities/innovation/dataand-reports/2022/mdpp-2ndannevalrpt.
337 Centers for Disease Control and Prevention
Diabetes Prevention Recognition Program.
Standards and Operating Procedures. Requirements
for CDC Recognition. June 2024. https://
nationaldppcsc.cdc.gov/s/article/DPRP-Standardsand-Operating-Procedures.
338 Health Care Innovation Awards. https://
www.cms.gov/priorities/innovation/innovationmodels/health-care-innovation-awards.
339 https://www.cdc.gov/diabetes/prevention/
index.html.
340 https://www.cdc.gov/diabetes/prevention/pdf/
dprp-standards.pdf.
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learning sessions, until December 31,
2027 (88 FR 79241).
CDC released the 2024 DPRP
Standards 341 to replace the 2021 DPRP
Standards in June 2024. To align MDPP
with the 2024 CDC DPRP Standards, we
are proposing conforming changes to
align with CDC delivery modes. These
changes are expected to reduce
administrative burden, ensure
compliance with existing MDPP
regulations, and streamline data
reporting for MDPP suppliers. In this
year’s rule, we are also proposing an
additional option for self-reporting
weight in an MDPP distance learning
session, removing the MDPP bridge
payment, and making minor edits to
align current rule language pertaining to
MDPP with previous rulemaking.
1. Proposed Changes to § 410.79 by
Amending Paragraphs (b) and (d)(1)
We established MDPP as an expanded
model in 2018 based on a Health Care
Innovation Award (HCIA) to the
National Young Men’s Christian
Association (YMCA) of the USA (Y–
USA), who tested the CDC’s National
DPP in the Medicare population through
their network of YMCAs in multiple
U.S. markets (DPP model test).342 The
DPP model test successfully met
statutory criteria for model
expansion,343 demonstrating 5 percent
weight loss from their starting weight by
participants (a key metric of the
program’s success) along with
statistically significant reductions in
Medicare spending, emergency
department (ED) visits, and inpatient
stays.344 The MDPP expanded model
was implemented through the
rulemaking process in two phases, in
the CY 2017 PFS (81 FR 80459 through
341 Centers for Disease Control and Prevention
Diabetes Prevention Recognition Program.
Standards and Operating Procedures. Requirements
for CDC Recognition. June 2024. https://
nationaldppcsc.cdc.gov/s/article/DPRP-Standardsand-Operating-Procedures.
342 L Hinnant, S Razi, R Lewis, A Sun, M Alva,
T Hoerger et al. Evaluation of the Health Care
Innovation Awards: Community Resource Planning,
Prevention, and Monitoring, Annual Report 2015.
RTI International. March 2016; https://
www.cms.gov/priorities/innovation/files/reports/
hcia-ymcadpp-evalrpt.pdf.
343 Paul Spitalnic. Certification of Medicare
Diabetes Prevention Program. Mar. 14, 2016.
https://www.cms.gov/Research-Statistics-Data-andSystems/Research/ActuarialStudies/Downloads/
Diabetes-Prevention-Certification-2016-03-14.pdf.
344 Rojas Smith. L., Amico, P., Hoerger, T. J.,
Jacobs, S., Payne. J., & Renaud, J.: Evaluation of the
Health Care Innovation Awards: Community
Resource Planning, Prevention, and Monitoring
Third Annual Report Addendum—August 2017
https://downloads.cms.gov/files/cmmi/hcia-crppmthirdannrptaddendum.pdf (pp. 858–914).
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80483) and CY 2018 PFS final rules (82
FR 53234 through 53339).
MDPP went into effect in 2018, with
supplier enrollment starting January 1,
2018, and beneficiary enrollment
starting April 1, 2018 (82 FR 53237).
After nearly 6 years of implementation,
through the CY 2024 PFS final rule, we
finalized updates to MDPP based on
lessons learned since the expanded
model’s launch, including updates to
definitions and the core services period
and extended the flexibilities allowed
under the PHE for COVID–19 for a
period of 4 years (88 FR 79241).
This year we propose to make
conforming changes to § 410.79(b),
Conditions of Coverage, to align with
the 2024 CDC DPRP Standards.345 In the
CY 2018 PFS final rule, we stated our
intention to align MDPP with CDC
DPRP Standards whenever possible (82
FR 53245). Several commenters
encouraged CMS to consider adopting
the same definitions for MDPP as CDC
uses for the National DPP, including
distance learning, online, and
combination modalities to better align
MDPP and the National DPP.
Commenters indicated that the addition
of definitions that are consistent with
the CDC’s definitions will reduce
confusion about MDPP (88 FR 79247).
To increase this alignment, we worked
closely with CDC to update the National
DPP and MDPP for CY 2024 final rule
(88 FR 79240 through 79256), as well as
the 2024 DPRP Standards.346 We agree
in aligning terminology where
applicable.
The CY 2024 PFS final rule
introduced and defined ‘‘distance
learning’’ and ‘‘combination delivery’’
for MDPP and provided a definition for
‘‘online delivery’’ (88 FR 79243). The
2024 CDC DPRP Standards include the
following delivery modes with
definitions: ‘‘in-person,’’ ‘‘distance
learning (live),’’ ‘‘in-person with a
distance learning component,’’ ‘‘online
(non-live),’’ and ‘‘combination with an
online component.’’ 347 These delivery
345 Centers for Disease Control and Prevention
Diabetes Prevention Recognition Program.
Standards and Operating Procedures. Requirements
for CDC Recognition. June 2024. https://
nationaldppcsc.cdc.gov/s/article/DPRP-Standardsand-Operating-Procedures.
346 Centers for Disease Control and Prevention
Diabetes Prevention Recognition Program.
Standards and Operating Procedures. Requirements
for CDC Recognition. June 2024. https://
nationaldppcsc.cdc.gov/s/article/DPRP-Standardsand-Operating-Procedures.
347 Centers for Disease Control and Prevention
Diabetes Prevention Recognition Program.
Standards and Operating Procedures. Requirements
for CDC Recognition. June 2024. https://
nationaldppcsc.cdc.gov/s/article/DPRP-Standardsand-Operating-Procedures.
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modes also serve as organization codes
for CDC DPRP recognition. Through this
proposed rule, we are proposing to
amend § 410.79(b) to add a new term for
MDPP, ‘‘in-person with a distance
learning component,’’ defined as
‘‘MDPP sessions that are delivered in
person by trained Coaches where
participants have the option of
attending sessions via MDPP distance
learning. These sessions must be
furnished in a manner consistent with
DPRP Standards for in-person and
distance learning sessions.’’ The
following examples of an acceptable
delivery model for the ‘‘in-person with
a distance learning component’’
delivery mode are provided in the 2024
CDC DPRP Standards: a combination of
in-person and distance learning during
the core (first 6 months) and core
maintenance (second 6 months) phases;
some participants within a cohort using
the in-person delivery mode and some
participants using the distance learning
delivery mode; or participants choosing
from session to session which mode (inperson or distance learning) they wish
to use.348
To further align with 2024 CDC DPRP
Standards, we also propose to add a
new term at § 410.79(b), ‘‘combination
with an online component,’’ defined as
‘‘sessions that are delivered as a
combination of online (non-live) with
in-person or distance learning. These
sessions must be furnished in a manner
consistent with the DPRP Standards for
the modality being used.’’ Furthermore,
we propose to remove the ‘‘combination
delivery’’ term from § 410.79(b), which
was added in the CY 2024 PFS final rule
(88 FR 79241) and is defined as ‘‘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.’’ We
believe that the MDPP ‘‘combination
delivery’’ term and definition are no
longer needed with the addition of ‘‘inperson with a distance learning
component,’’ which includes any
combination of in-person and distance
learning sessions.
Lastly, we are proposing to modify the
current term and definition for ‘‘online
delivery’’ at § 410.79(b), also added by
the CY 2024 PFS final rule (88 FR
79241), to align with the 2024 CDC
DPRP Standards.349 First, we are
348 Centers for Disease Control and Prevention
Diabetes Prevention Recognition Program.
Standards and Operating Procedures. Requirements
for CDC Recognition. June 2024. https://
nationaldppcsc.cdc.gov/s/article/DPRP-Standardsand-Operating-Procedures.
349 Centers for Disease Control and Prevention
Diabetes Prevention Recognition Program.
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proposing to update the term from
‘‘online delivery’’ to ‘‘online’’ to align
with both the MDPP ‘‘distance learning’’
term and CDC DPRP ‘‘online (non-live)’’
term. We propose to revise the
definition for the MDPP ‘‘online’’
delivery mode to provide that sessions
that are delivered one hundred percent
(100%) through the internet via phone,
tablet, or laptop in an asynchronous
(non-live) classroom where participants
are experiencing the content on their
own time without a live (including nonartificial intelligence (AI)) Coach
teaching the content. These sessions
must be furnished in a manner
consistent with the DPRP Standards for
online sessions. Live Coach interaction
must be offered to each participant
during weeks when the participant has
engaged with content. Emails and text
messages can count toward the
requirement for live Coach interaction if
there is bi-directional communication
between the Coach and participant. Chat
bots and AI forums do not count as live
Coach interaction. This modified
definition adds the term ‘‘non-live’’ and
further clarifies that Chat bots and AI
forums do not constitute live
interaction.
In summary, we are revising the
‘‘online’’ definition and adding the
‘‘combination with an online
component’’ term and definition to help
align terminology between MDPP and
DPRP and prevent confusion about
acceptable CDC delivery modes for
MDPP. We are confirming that only
MDPP ‘‘in-person,’’ ‘‘distance learning,’’
and ‘‘in-person with a distance learning
component’’ delivery modes, can be
used during the extension of the
flexibilities allowed under the COVID–
19 PHE, as finalized in the CY 2024 PFS
final rule (88 FR 79241), not ‘‘online’’
nor ‘‘combination with an online
component’’ delivery modes.
Furthermore, in the CY 2021 PFS final
rule, we established that virtual sessions
performed under flexibilities finalized
in that rule could only be performed by
MDPP suppliers who offered in-person
services (85 FR 84830). For the MDPP
Extended flexibilities period, we
finalized in the CY 2024 PFS final rule
to limit virtual delivery to the CDC
DPRP definition of ‘‘distance learning’’
(88 FR 79243). We stated that the MDPP
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
Standards and Operating Procedures. Requirements
for CDC Recognition. June 2024. https://
nationaldppcsc.cdc.gov/s/article/DPRP-Standardsand-Operating-Procedures.
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sessions (88 FR 79244). A make-up
session in MDPP was described in CY
2018 PFS final rule (82 FR 53241) and
at § 410.79(a) as ‘‘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.’’ The 2024 CDC DPRP
Standards allow for National DPP makeup sessions to be furnished using any
delivery mode, including online.350 In
alignment with the CY 2024 final rule,
we are proposing to amend
§ 410.79(d)(1) to clarify that MDPP
make-up sessions can only be furnished
using the modalities permitted by the
CY 2024 final rule for MDPP sessions:
distance learning and in-person delivery
(88 FR 79243 through 79246).
Specifically, we propose to add the
following: ‘‘MDPP make-up sessions
may only use in-person or distance
learning delivery.’’
We are proposing to amend
§ 410.79(b) and (d)(1) and seek comment
on these proposals.
2. Proposed Changes to
§ 410.79(e)(3)(iii)
As part of MDPP’s Emergency Policy
finalized in the CY 2021 PFS final rule,
we allowed for virtual weight collection
(88 FR 79249). We summarized our
policies for alternatives to the
requirement for in-person weight
collection at Alternatives to the
requirement for in-person weight
measurement (§ 410.79(e)(3)(iii)), which
permit 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 (88 FR
79243). 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
350 Centers for Disease Control and Prevention
Diabetes Prevention Recognition Program.
Standards and Operating Procedures. Requirements
for CDC Recognition. June 2024. https://
nationaldppcsc.cdc.gov/s/article/DPRP-Standardsand-Operating-Procedures.
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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 has allowed
suppliers to bill for MDPP beneficiaries
achieving weight loss performance
goals.
Overall, commenters on the proposed
MDPP Extended flexibilities in the CY
2024 PFS rule were very supportive of
CMS continuing to allow virtual weight
collection (88 FR 79240 through 79256).
However, we received several comments
regarding barriers suppliers experienced
relating to virtual weight collection
during the PHE for COVID–19. For
example, several commenters
recommended that CMS no longer
require date-stamped photos to
document the self-reported beneficiary
weights (88 FR 79249). The commenters
also reported that many of their
beneficiaries are unable to take a picture
while standing on their home scales due
to risk of injury and physical health
limitations. Commenters stated that this
risk has prevented organizations from
submitting claims accurately, since they
have several participants who live alone
and attend sessions via distance
learning (88 FR 79249). We
acknowledged in our responses to these
comments that some MDPP
beneficiaries may lack the technology or
capacity to provide a date-stamped
photograph to document their body
weight measurements. We stated that in
situations in which beneficiaries may be
unable to self-report their weight
according to the MDPP conditions of
coverage, suppliers may want to
consider collecting weight
measurements from the MDPP
beneficiary in person.
We have continued to hear from
MDPP suppliers and interested parties
that the requirement to submit a photo
with both the beneficiary’s weight on
the scale and the beneficiary visible is
not physically possible. This problem
has become even more relevant in CY
2024 as suppliers continue to expand
distance learning to help reach
beneficiaries in rural and underserved
areas, sometimes across state lines. We
previously responded that for situations
in which beneficiaries may be unable to
self-report their weight according to the
MDPP conditions of coverage, suppliers
may want to consider collecting weight
measurements from the MDPP
beneficiary in person (88 FR 79249).
However, this may not be a practical
option for beneficiaries who have
chosen distance learning based on not
living within driving distance from an
MDPP supplier location. Therefore, we
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propose revising § 410.79(e)(3)(iii)(C) to
provide 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 athome digital scale, or the MDPP
supplier receives 2 (two) date-stamped
photos or a video recording of the
beneficiary’s weight, with the
beneficiary visible on the scale,
submitted by the MDPP beneficiary to
the MDPP supplier. Photo or video must
clearly document the weight of the
MDPP beneficiary as it appears on their
digital scale on the date associated with
the billable MDPP session. If choosing
to submit 2 photos, one photo must
show the beneficiary’s weight on the
digital scale, the second photo must
show the beneficiary visible in their
home, and both photos must be datestamped. Similar to options in
paragraphs (e)(3)(iii)(A) and (B) in
§ 410.79, this revised option in
paragraph (e)(30(iii)(C) is only available
for MDPP beneficiaries reporting their
weight for an MDPP distance learning
session. We are continuing to require
the date-stamp on both photos to ensure
program integrity in the virtual setting.
We are proposing to amend
§ 410.79(e)(3)(iii). We seek comment on
these proposals.
Lastly, we finalized in the CY 2021
PFS final rule that the flexibilities under
§ 410.79(e)(3)(iii) and (iv) would only
apply only to MDPP suppliers that have
and maintain CDC DPRP ‘‘in-person’’
recognition (85 FR 84831). In the CY
2024 PFS final rule, we extended
flexibilities allowed during the PHE for
COVID–19 or 4 years, or through
December 31, 2027 (88 FR 79241). We
also confirmed that that the Extended
flexibilities would continue to only
apply to MDPP suppliers that have and
maintain CDC DPRP ‘‘in-person’’
recognition, and that virtual only
suppliers were not permitted to furnish
the Set of MDPP services because MDPP
beneficiaries may elect to return to inperson services, and MDPP suppliers
need to be able to accommodate their
request (88 FR 79248).
To reduce confusion as MDPP
suppliers transition to the new CDC
DPRP recognition for ‘‘in-person with a
distance learning component,’’ we are
clarifying that MDPP suppliers can have
and maintain either CDC’s ‘‘in-person’’
or the new ‘‘in-person with a distance
learning component’’ CDC DPRP code.
The 2024 CDC DPRP Standards,
implemented in June 2024, introduced
and defined the new ‘‘in-person with a
distance learning component’’ modality
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and associated code.351 This new
modality and code for recognition
include a combination of in-person and
distance learning delivery, which are
both modalities currently permitted
until December 31, 2027 (88 FR 79241).
The new MDPP term and definition for
‘‘in person with a distance learning
component’’ that we are proposing to
align with the 2024 CDC DPRP
Standards will replace the current
MDPP ‘‘combination delivery’’ term,
which we are proposing to remove in
this rulemaking. Aligning terminology
for delivery of MDPP that involves a
combination of in-person and distance
learning delivery with the 2024 CDC
DPRP Standards would reduce
administrative burden to MDPP
suppliers and allow them to streamline
CDC DPRP data submission (that is, they
will not have to submit data for two
CDC organization codes). MDPP
suppliers will not be required to switch
to this new code if they already have an
in-person code; it is only being made
available for their convenience.
3. Proposed Changes to § 414.84(a), (c),
(d), and (e)
We further propose to amend
§ 414.84(a), (d), and (e) to remove the
MDPP bridge payment. This payment is
no longer necessary in MDPP’s CY 2024
FFS payment structure for attendance
and could introduce the potential for
fraud, waste, or abuse.
The CY 2017 PFS final rule confirmed
that a beneficiary may change MDPP
suppliers at any time (81 FR 80470). The
MDPP bridge payment was introduced
in the CY 2018 PFS final rule at
§ 414.84(a) and is defined as follows:
‘‘Bridge payment means a one-time
payment to an MDPP supplier for
furnishing its first MDPP session to an
MDPP beneficiary who has previously
received one or more MDPP services
from a different MDPP supplier’’ (81 FR
80470). The CY 2018 PFS final rule
specified that an MDPP supplier that
had previously been paid either a bridge
payment or a performance payment for
an MDPP beneficiary was not eligible to
be paid a bridge payment for that
beneficiary, along with other conditions.
An MDPP supplier may only receive
one bridge payment per MDPP
beneficiary, however, there is no limit
on how many MDPP suppliers can
receive a bridge payment for the same
beneficiary (82 FR 53361).
351 Centers for Disease Control and Prevention
Diabetes Prevention Recognition Program.
Standards and Operating Procedures. Requirements
for CDC Recognition. June 2024. https://
nationaldppcsc.cdc.gov/s/article/DPRP-Standardsand-Operating-Procedures.
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The CY 2018 PFS final rule also noted
that the MDPP bridge payment was
intended to be similar (that is, the same
amount) to the payment for the first core
session furnished by the previous
supplier and would be received only if
the subsequent supplier did not furnish
the first core session to the MDPP
beneficiary (82 FR 53361). In the
performance-based payment structure,
the bridge payment was intended to
prevent scenarios where subsequent
MDPP suppliers would receive no
payment for sessions furnished to MDPP
beneficiaries who changed suppliers
during the MDPP services period in the
absence of the bridge payment. We
stated that the bridge payment was not
intended to be a performance payment;
rather, it would account for the financial
risk a subsequent MDPP supplier took
on by furnishing services to a
beneficiary changing MDPP suppliers
during the MDPP services period (82 FR
53293). However, such risk is not
applicable in an FFS payment structure.
Along with the performance payments
for weight loss, the MDPP bridge
payment was retained in the CY 2024
Fee Schedule for MDPP (88 FR 79252).
Currently, a subsequent MDPP supplier
can receive both an attendance payment
and a bridge payment for the first
session attended by an MDPP
beneficiary who switches suppliers. For
example, in CY 2024, if a beneficiary
changed suppliers on MDPP session 8,
the subsequent supplier could receive
both the attendance payment for session
8 ($25) and the bridge payment ($25).
The bridge payment for this beneficiary
could only be received by this supplier
once, but if the beneficiary changed
suppliers again (for example, on session
17), the new (second) subsequent
supplier could also receive the bridge
payment in addition to the payment for
session 17 ($25). This could continue as
many times as the beneficiary changed
suppliers until they have the maximum
of 22 sessions paid, across all suppliers,
with no maximum on the total number
of bridge payments. In the CY 2018 PFS
final rule, we noted some program
integrity risk that organizations could
coordinate to bill multiple bridge
payments that would ultimately
increase total MDPP payments to
separately enrolled MDPP suppliers to
serve the financial interests of the
umbrella organization. This scenario
could occur if MDPP suppliers
systematically encouraged beneficiaries
to change suppliers for the purpose of
being paid the bridge payment (82 FR
53294). Due to these reasons, we
propose to amend § 414.84(a), (d), and
(e) to remove reference to, and
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requirements of the MDPP bridge
payment. Per our Regulatory Impact
Analysis, we expect removal of the
MDPP bridge payment to be budget
neutral for the Medicare program. We
seek comment on these proposals.
Additionally, at § 414.84(c), facilitate
Medicare Administrative Contractors
(MACs) in processing claims for same
day make-up sessions in MDPP, we are
proposing to require MDPP suppliers to
append an existing claim modifier to
any claim for G9886 or G9887 that
indicates a make-up session that was
held on the same day as a regularly
scheduled MDPP session. The CY 2018
PFS final rule permits an MDPP
beneficiary to have one make-up session
on the same day as a regularly
scheduled session and for a beneficiary
to have one make-up session per week
(82 FR 53360), consistent with CDC
DPRP Standards.352 In the CY 2024 PFS
final rule, we stated that we wanted to
encourage suppliers to schedule makeup sessions on days other than the same
day of a regularly scheduled session to
avoid claims being rejected or denied
under the new CY 2024 FFS payment
schedule and to allow beneficiaries to
receive the benefit as intended by
having access to the full 12 months
MDPP service period to build the skills
needed to reduce their risk for diabetes
(88 FR 79250).
However, since then, we have heard
from MDPP suppliers that same day
make-up sessions are an essential
flexibility that assist an MDPP
beneficiary in staying on track with the
curriculum and their cohort after an
MDPP beneficiary needs to miss a
regularly scheduled session. To help
prevent potential claim rejections for
duplicate services, we are proposing to
require MDPP suppliers to append a
modifier to the applicable G-code for the
second session held on the same day as
a regularly scheduled MDPP session.
Specifically, we are proposing to add
§ 414.84(c)(4), which states that
‘‘Current Procedural Terminology (CPT)
Modifier 79 (repeat services by same
physician) must be appended to any
claim for G9886 or G9887 to identify a
MDPP make-up session that was held on
the same day as a regularly scheduled
MDPP session.’’ We believe this new
requirement would contribute minimal
additional complexity to the payment
structure while creating a flexibility that
would have value for the program,
particularly for beneficiaries in the core
352 Centers for Disease Control and Prevention
Diabetes Prevention Recognition Program.
Standards and Operating Procedures. Requirements
for CDC Recognition. June 2024. https://
nationaldppcsc.cdc.gov/s/article/DPRP-Standardsand-Operating-Procedures.
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phase of MDPP who may not have
transportation to 2 in-person sessions in
one week or have the flexibility to make
time on more than one day per week for
a distance learning session.
Additionally, we believe the existing
limitation on one make-up session per
week would be sufficient to ensure
program benefit because whether the
make-up session is held on the same
day, or the next day would likely have
minimal impact on program duration
and intensity. To clarify, we are
proposing that the CPT Modifier 79
would only need to be appended to the
HCPCS code (G9886 or G9887) that
identifies the session that included
content from a previously held session
that serves as a makeup session for the
session the MDPP beneficiary missed,
which was held on the same day as a
regularly scheduled MDPP session. This
modifier would not need to be included
on claims for make-up sessions held on
different days than regularly scheduled
MDPP sessions.
Lastly, with the removal of
§ 414.84(d), we are proposing to amend
the current § 414.84(e) to be the new
§ 414.84(d). We are also removing from
the new § 414.84(d) the reference to
updating the MDPP bridge payment, as
the bridge payment has been proposed
to be removed from this CY 2025
Physician Fee Schedule rulemaking.
We also seek comment on these
proposals.
4. Aligning language with previous
rulemaking in §§ 410.79, 424.205, and
414.84
We are proposing minor edits
throughout §§ 410.79, 424.205, and
414.84 to update outdated references
and align with previous rulemaking
pertaining to MDPP terminology,
payment structure, and requirements.
This includes updating references to the
performance-based payments for
attendance and ongoing maintenance
sessions, which were both removed
from the 2024 MDPP Fee Schedule by
the CY 2024 PFS final rule (88 FR
79252), as well as including the
clarification that suppliers can offer
MDPP sessions via distance learning, a
flexibility extended by the CY 2024 PFS
final rule (88 FR 79241), where
applicable.
At § 410.79(b), we propose to update
the definition for the ‘‘Set of MDPP
services’’ to remove the reference to
‘‘ongoing maintenance’’ sessions. All
references to and requirements for the
MDPP ‘‘ongoing maintenance’’ phase
were removed by the CY 2024 PFS
finale rule (88 FR 79256). We are
revising this definition to read: ‘‘Set of
MDPP services means the series of
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MDPP sessions, composed of core
sessions and core maintenance sessions,
and subject to paragraph (c)(3) of this
section offered over the course of the
MDPP services period.’’
We also propose
§ 410.79(e)(3)(iv)(F)(3) to state that no
more than 12 virtual sessions offered
monthly during the ongoing
maintenance session intervals, months
13 through 24 for beneficiaries enrolled
before January 1, 2022.
This proposed revision adds the date
that the CY 2022 PFS final rule was
effective, which is the date when no
more MDPP beneficiaries could enroll
in ongoing maintenance sessions (86 FR
65317).
At § 410.79(e)(3)(v)(F)(2), we propose
to remove the reference to weight
measurement at an ongoing
maintenance session, so the paragraph
provides that for an MDPP beneficiary
who began receiving the Set of MDPP
services on or after January 1, 2021, has
suspended services during an applicable
1135 waiver event, the MDPP supplier
must use the baseline weight recorded
at the beneficiary’s first core session.
At § 424.205(c)(10), we propose
revision to specify in-person and
distance learning delivery for MDPP
core and core maintenance sessions, to
provide that, except as allowed under
§ 424.205(d)(8), the MDPP supplier must
offer an MDPP beneficiary no fewer than
all of the following:
• 16 in-person or distance learning
core sessions no more frequently than
weekly for the first 6 months of the
MDPP services period, which begins on
the date of attendance at the first such
core session.
• 1 in-person or distance learning
core maintenance session each month
during months 7 through 12 (6 months
total) of the MDPP services period.
At § 424.205(f)(1)(ii), we propose to
remove reference to the HICN, as
Medicare is now using Medicare
Beneficiary Identifiers (MBIs),353 to
state: Basic beneficiary information for
each MDPP beneficiary in attendance,
including but not limited to beneficiary
name, MBI, and age.
At § 424.205(f)(2)(i), we propose to
replace ‘‘whether a core session, a core
maintenance session, an in-person
make-up session, or a virtual make-up
session’’ with the two currently
permitted types of sessions (that is, inperson and distance learning), to state:
Documentation of the type of session
(in-person or distance learning).
At § 424.205(f)(5), we propose to
remove the references to the MDPP
353 https://www.cms.gov/training-education/
partner-outreach-resources/new-medicare-card/
medical-beneficiary-identifiers-mbis.
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performance-based payments for
attendance in paragraphs (f)(5)(i) and (ii)
because these payments were removed
in the CY 2024 Fee Schedule for MDPP
(88 FR 79252). In their place, we are
adding references to the performance
payment for the required minimum 5
percent weight loss (82 FR 53289). We
also propose to correct the references to
§ 414.84(b), and also to remove the
reference to the ongoing maintenance
sessions from 424.205(f)(5)(iv).
At § 414.84(b)(1), we propose to
clarify that the performance payment for
the required minimum weight loss is
made for 5 percent weight loss, as
reflected in the CY 2024 Fee Schedule
(88 FR 79252), and can be made for a
distance learning, as well as an inperson MDPP session, as allowed by the
COVID–19 PHE flexibilities (85 FR
84830 through 84841) and their
extension (88 FR 79241). Performance
Goal 1 provides that it achieves the
required minimum 5-percent weight
loss. CMS makes a performance
payment to an MDPP supplier for an
MDPP beneficiary who achieves the
required minimum weight loss as
measured in-person or during a distance
learning session during a core session or
core maintenance session furnished by
that supplier.
Similarly, we propose to revise
§ 414.84(b)(2) for 9 percent weight loss.
Performance Goal 2 provides that it
achieves 9-percent weight loss. CMS
makes a performance payment to an
MDPP supplier for an MDPP beneficiary
who achieves at least a 9-percent weight
loss as measured in-person or in a
distance learning session during a core
session or core maintenance session
furnished by that supplier.
We seek comment on these proposals.
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
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episodes of care for the treatment of
OUD furnished by OTPs. We also
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.
Since the CY 2020 PFS final rule, we
have made several refinements and
expansions to services covered under
the Medicare OTP benefit. Specifically,
we adopted new add-on codes for take
home supplies of nasal naloxone and
injectable naloxone (85 FR 84683
through 84692) in the CY 2021 PFS final
rule, and a new add-on code and
payment for a higher dose of nasal
naloxone (86 FR 65340 and 65341) in
the CY 2022 PFS final rule. We have
also finalized various
telecommunications flexibilities,
including: to allow OTPs to furnish
individual and group therapy and
substance use counseling via two-way
interactive audio-video
telecommunications (84 FR 62630
through 62677 and 84 FR 62919 through
62926) in the CY 2020 PFS final rule,
and via audio-only telephone calls
when audio-video telecommunications
are not available to the beneficiary (86
FR 65342) in the CY 2022 PFS final rule;
to allow the OTP intake add-on code to
be furnished via two-way interactive
audio-video telecommunications when
billed for the initiation of treatment
with buprenorphine, and via audio-only
telecommunications when audio-video
telecommunications are not available to
the beneficiary, to the extent that these
technologies are authorized by the Drug
Enforcement Administration (DEA) and
the Substance Abuse and Mental Health
Services Administration (SAMHSA) at
the time the service is furnished (87 FR
69775 through 69777) in the CY 2024
final rule; and to allow periodic
assessments to be furnished via two-way
interactive audio-video
telecommunications as clinically
appropriate (85 FR 84690) in the CY
2021 final rule. OTPs may furnish these
aforementioned services via
telecommunications systems provided
all other applicable requirements are
met. Additionally, for the purposes of
the geographic adjustment, we have
clarified, in the CY 2023 final rule, that
services furnished via OTP mobile units
will be treated as if the services were
furnished in the physical location of the
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OTP for purposes of determining
payments to OTPs under the Medicare
OTP bundled payment codes and/or
add-on codes, as long as services are
medically reasonable and necessary and
comply with SAMHSA and DEA
guidance (87 FR 69768 through 69777).
Lastly, we have made a few changes to
various pricing methodologies under the
OTP benefit in the 2023 PFS final rule,
including: revising our methodology for
pricing the drug component of the
methadone weekly bundle and the addon code for take-home supplies of
methadone by using the Producer Price
Index (PPI) for Pharmaceuticals for
Human Use (Prescription) to better
reflect the changes in methadone costs
for OTPs over time (87 FR 69768
through 69777); and modifying the
payment rate for individual therapy in
the non-drug component of the bundled
payment 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 (87 FR
69768 through 69777).
More recently, for CY 2024, CMS
made further modifications and
expansions to covered services for the
treatment of OUD by OTPs. In the CY
2024 PFS final rule (88 FR 79089
through 79093), CMS finalized an
extension to allow periodic assessments
to be furnished audio-only through the
end of CY 2024 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.
In the final rule, we noted that
extending these flexibilities another
year would 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. Lastly, in the CY
2024 Outpatient Prospective Payment
System (OPPS) final rule (88 FR 81845
through 81858), CMS finalized an addon code for intensive outpatient
program (IOP) services furnished by
OTPs for the treatment of OUD and
added a new paragraph (ix) in the
definition of ‘‘Opioid disorder treatment
service’’ at § 410.67(b) to describe such
services. We stated that Medicare would
pay for IOP services provided by OTPs
if each service is medically reasonable
and necessary and not duplicative of
any service paid for under any bundled
payments billed for an episode of care
in a given week, and other applicable
requirements are met. We believe that
payment for IOP services will improve
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continuity of care between different
treatment settings and levels of care,
and further promote health equity for
Medicare beneficiaries that may face
barriers to accessing treatment, such as
racial/ethnic minorities and/or
beneficiaries aged 65 or older. We
continue to monitor utilization of OUD
treatment services furnished by OTPs to
ensure that Medicare beneficiaries have
appropriate access to care. For CY 2025,
we are proposing several modifications
to the policies governing Medicare
coverage and payment for OUD
treatment services furnished by OTPs.
2. Telecommunication Flexibilities for
Periodic Assessments and Initiation of
Treatment With Methadone
We have finalized several flexibilities
for OTPs regarding the use of
telecommunications, both during the
Public Health Emergency (PHE) for the
Coronavirus Disease 2019 (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 audiovideo communication technology. 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
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
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/
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video interaction because in each of
these instances audio/video
communication technology is not able
to be used in furnishing services to the
beneficiary. 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 PHE for COVID–19 in paragraph
(vi) in the definition of opioid use
disorder treatment service at § 410.67(b).
Specifically, we allowed the OTP intake
add-on code to be furnished via twoway, 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.
a. Proposal To Allow Periodic
Assessments To Be Furnished Via
Audio-Only Telecommunications on a
Permanent Basis
In recent years, we have finalized
several telecommunication flexibilities
for periodic assessments furnished by
OTPs. 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 face-
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to-face encounter, which includes
services furnished via two-way
interactive audio-video communication
technology, as clinically appropriate,
provided all other applicable
requirements are met, on a permanent
basis.
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 allowing
audio-only flexibilities would further
promote health equity for individuals
who are economically disadvantaged,
live in rural areas, are members of racial
and ethnic minorities, lack access to
reliable broadband or internet access, or
do not possess devices with video
capability. Commenters also indicated
that periodic assessments are no less
complex than intake/initial assessments,
and thus are equally appropriate for
audio-video and audio-only care, and
that permitting audio-only flexibilities
would allow an opportunity for both the
provider and patient to jointly
determine that the patient would
individually benefit from telehealth
services. After considering these
comments, we 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.
Moreover, section 4113 of Division
FF, Title IV, Subtitle A of the
Consolidated Appropriations Act, 2023
(CAA, 2023) (Pub. L. 117–328,
December 29, 2022) extended the
telehealth flexibilities enacted in the
Consolidated Appropriations Act, 2022
(CAA, 2022) (Pub. L. 117–103, March
15, 2022). Specifically, it amended
sections 1834(m), 1834(o), and 1834(y)
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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 PHE for
COVID–19 had ended prior to that date.
Additionally, it extended the
flexibilities that were available during
the PHE that allowed 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 had ended 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 were
extended through the end of CY 2024.
To better align coverage for periodic
assessments furnished by OTPs with the
telehealth flexibilities described in
section 4113 of the CAA, 2023 for other
settings under Medicare, in the CY 2024
PFS final rule (88 FR 79089 through
79093; 79528), we finalized extending
the audio-only flexibilities for periodic
assessments furnished by OTPs through
the end of CY 2024 in paragraph (vii) in
the definition of ‘‘Opioid use disorder
treatment service’’ at § 410.67(b). We
finalized to 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.
In submitted comments supporting the
proposal, commenters reiterated
evidence showing that audio-only
telehealth encounters are more
prominent among individuals who are
older, Black, Hispanic, American
Indian/Alaska Native, Spanishspeaking, living in areas with low
broadband access, low-income, and
with public insurance, suggesting that
the proposal would have positive health
equity implications for these
populations.354 Several other
354 J.A. Rodriguez et al., ‘‘Differences in the Use
of Telephone and Video Telemedicine Visits During
the COVID–19 Pandemic,’’ The American Journal of
Managed Care 27, no. 1 (2021), https://
www.ajmc.com/view/differences-in-the-use-oftelephone-and-video-telemedicine-visits-during-thecovid-19-pandemic; R.P. Pierce and J.J. Stevermer,
‘‘Disparities in Use of Telehealth at the Onset of the
COVID–19 Public Health Emergency,’’ Journal of
Telemedicine and Telecare (2020): 1–7, https://
doi.org/10.1177/1357633X20963893; J.E. Chang et
al., ‘‘Patient Characteristics Associated with Phone
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61819
commenters raised that audio-only
flexibilities are important since many
underserved populations may
experience challenges in partaking in
video-based telehealth services, due to
not possessing the needed technological
proficiencies to operate video-based
services, not having a caregiver able to
assist them with appointments, feeling
discomfort with the use of video, and
because of the cost of high-speed
internet and data required for video
technologies. Several other commenters
shared evidence that audio-only visits
produce many of the same benefits as
video-based visits,355 and that patients
often report that audio-only visits left
them feeling supported and with greater
privacy, provided increased access to
behavioral health professionals, and
helped reduce transportation barriers.356
Lastly, a large number of commenters
requested that CMS make the extension
for audio-only periodic assessments
permanent beyond CY 2024.
Commenters stated that extending this
policy permanently would retain a
beneficiary’s right to decide with their
provider how best to receive their care
and would curtail existing barriers that
Medicare beneficiaries with an OUD
may face in accessing care. In response
to these comments that requested
indefinitely extending these audio-only
flexibilities for periodic assessments,
CMS stated that extending these
flexibilities for one additional year at
the time would allow the agency time to
further examine the issue, including to
understand if a permanent extension
would be appropriate for patients who
are receiving treatment via
buprenorphine, methadone, and/or
naltrexone at OTPs, and whether proper
safeguards are in place so these services
can be delivered in a way that would
not diminish safety or quality of care for
Medicare beneficiaries with an OUD.
We continue to monitor the services
provided under the OTP benefit to
Versus Video Telemedicine Visits for Substance
Use Treatment During COVID–19,’’ J Addict Med
16, no. 6 (2022): 659–65; C. Shoff, T–C Yang, B.A.
Shaw, ‘‘Trends in Opioid Use Disorder Among
Older Adults: Analyzing Medicare Data, 2013–
2018,’’ American Journal of Preventive Medicine
60, no.6 (2021): 850–855, https://doi.org/10.1016/
j.amepre.2021.01.010.
355 Danila, M.I., Sun, D., Jackson, L.E., Cutter, G.,
Jackson, E.A., Ford, E.W., DeLaney, E., Mudano, A.,
Foster, P.J., Rosas, G., Melnick, J.A, Curtis, J.R., &
Saag, K.G. (2022, November). ‘‘Satisfaction with
modes of telemedicine delivery during COVID–19:
A randomized, single-blind, parallel group,
noninferiority trial.’’ The American Journal of the
Medical Sciences, 364 (5).
356 Kang AW, Walton M, Hoadley A, DelaCuesta
C, Hurley L, Martin R. ‘‘Patient Experiences with
the Transition to Telephone Counseling during the
COVID–19 Pandemic.’’ Healthcare (Basel).
2021;9(6):663. Published 2021 Jun 2. doi:10.3390/
healthcare9060663.
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ensure flexibilities for OUD treatment
services are consistent with flexibilities
authorized in other settings under
Medicare, as medically reasonable and
necessary for the diagnosis and
treatment of OUD. In the CY 2022 PFS
final rule, we revised the regulatory
definition of ‘‘interactive
telecommunications system’’ at
§ 410.78(a)(3) for Medicare Telehealth
services paid under the PFS beyond the
termination of the PHE for COVID–19 to
allow for inclusion of audio-only
services under certain circumstances.
Specifically, we redefined ‘‘interactive
telecommunications system’’ to include
audio-only communications technology
when used for telehealth services for the
diagnosis, evaluation, or treatment of
mental health disorders furnished to a
patient in their home. We also finalized
to limit payment for audio-only services
to services furnished by a physician or
practitioner that has the technical
capability at the time of the service to
use two-way audio-video
telecommunications, but where the
patient is not capable of, or does not
consent to, the use video technology for
the service, and the patient is located at
their home at the time of service. Lastly,
we clarified that SUD services are
considered mental health services for
purposes of the expanded definition of
‘‘interactive telecommunications
system’’ to include audio-only services
under § 410.78(a)(3). In short, these
flexibilities and policy clarifications
that permit audio-only
telecommunication flexibilities for the
treatment of a SUD, which can include
an OUD, already exist under other
payment systems in Medicare.
Therefore, to better align coverage for
periodic assessments furnished by OTPs
with other telehealth services furnished
under the PFS for the diagnosis,
evaluation, or treatment of a mental
health disorder including SUDs, and in
response to many supportive comments
received in response to the CY 2024 PFS
proposed rule that advocated for
allowing OTPs to furnish periodic
assessments via audio-only
telecommunications on a permanent
basis, we are proposing to allow OTPs
to furnish periodic assessments using
audio-only communications technology
when video is not available on a
permanent basis beginning January 1,
2025. Under this proposal, we would
allow periodic assessments to be
furnished via 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
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time the service is furnished, and all
other applicable requirements are met.
We believe permanently extending
this flexibility would meaningfully
promote access to care for the Medicare
population, as supported by our
analysis of claims data showing 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 to 80 years of age, and
47 percent of visits for patients over 81
years of age.357 Evidence further reveals
that Medicare beneficiaries who are
older than 65 years old, racial/ethnic
minorities, dual-enrollees in Medicare
and Medicaid, or living in rural areas,
or who experience low broadband
access, low-income, and/or for whom
English in not their primary language,
are more likely to be offered and use
audio-only telemedicine services than
audio-video services.358 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.359
Telemedicine flexibilities have been
shown to be feasible and effective for
rural patients with an OUD with data
supporting that telemedicine
flexibilities have helped improve
treatment retention in OUD treatment,
especially for rural patients who are
357 Lee, G., & Stewart, K. (n.d.). ‘‘2021 Medicare
coverage and payment for audio only services
(Telephone e/m).’’ AAMC. https://www.aamc.org/
media/55296/download.
358 Rodriguez, J.A., Betancourt, J.R., Sequist, T.D.,
& Ganguli, I. (2021). ‘‘Differences in the use of
telephone and video telemedicine visits during the
COVID–19 pandemic.’’ The American Journal of
Managed Care, 27(1), 21–26. https://doi.org/
10.37765/ajmc.2021.88573; Koma, W., Cubanski, J.,
& Published, T.N. (2021, May 19). ‘‘Medicare and
telehealth: Coverage and use during the covid-19
pandemic and options for the future.’’ KFF. https://
www.kff.org/medicare/issue-brief/medicare-andtelehealth-coverage-and-use-during-the-covid-19pandemic-and-options-for-the-future/; ;Benjenk, I.,
Franzini, L., Roby, D., & Chen, J. (2021). ‘‘Disparities
in Audio-Only Telemedicine use among Medicare
beneficiaries during the coronavirus disease 2019
pandemic.’’ Medical Care, 59(11), 1014. https://
doi.org/10.1097/MLR.0000000000001631.
359 Federal Communications Commission. (2020).
‘‘2020 Broadband Deployment Report’’ (FCC 20–
50). https://docs.fcc.gov/public/attachments/FCC20-50A1.pdf; Centers for Medicare and Medicaid
Services, Division of Tribal Affairs. (n.d.).
Telehealth and COVID–19. https://www.cms.gov/
files/document/aian-telehealthwebinar.pdf; Shoff,
C., Yang, T.-C., & Shaw, B.A. (2021). ‘‘Trends in
opioid use disorder among older adults: Analyzing
Medicare data, 2013–2018.’’ American Journal of
Preventive Medicine, 60(6), 850–855. https://
doi.org/10.1016/j.amepre.2021.01.010.
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older and covered by Medicare.360
Lastly, these audio-only flexibilities
would be meaningful for OTPs and their
patients because telehealth services
have become widely used among SUD
treatment facilities as regular service
offerings. During the COVID–19
pandemic, SUD treatment facilities
increased telemedicine offerings by 143
percent, and as of 2021, almost 60
percent of SUD treatment facilities offer
telehealth.361 Now, telephone-based
(that is, audio-only) therapy provided by
SUD programs has been found to be one
of the most common modes of telehealth
for treatment of OUD.362 Given the
prevalence of audio-only modalities of
care for the treatment of OUD,
permanently extending this flexibility
could help prevent disruptions to care
in OTP settings that may regularly
provide periodic assessments via audioonly telehealth to Medicare
beneficiaries. For these reasons, we
believe a permanent extension would be
appropriate for patients who are
receiving buprenorphine, methadone,
and/or naltrexone at OTPs, and that
proper safeguards are in place so these
services can be delivered in a way that
would not diminish safety or quality of
care for Medicare beneficiaries with an
OUD.
Accordingly, we are proposing to
revise paragraph (vii) of the definition of
‘‘Opioid treatment services’’ at
§ 410.67(b) of the regulations to remove
the references to the ‘‘Public Health
Emergency, as defined in § 400.200 of
this chapter’’ and ‘‘through the end of
CY 2024,’’ in order to reflect that this
flexibility would be implemented on a
permanent basis. We would continue to
state that ‘‘in cases where a beneficiary
does not have access to two-way audiovideo communications technology,
periodic assessments can be furnished
using audio-only telephone calls if all
other applicable requirements are met.’’
We welcome comments on this proposal
to permanently extend this audio-only
flexibility for periodic assessments.
360 Lira, M.C., Jimes, C., & Coffey, M.J. (2023).
‘‘Retention in telehealth treatment for opioid use
disorder among rural populations: A retrospective
cohort study.’’ Telemedicine Journal and E-Health,
29(12), 1890–1896. https://doi.org/10.1089/
tmj.2023.0044.
361 Cantor, J., McBain, R.K., Kofner, A., Hanson,
R., Stein, B.D., & Yu, H. (2022). ‘‘Telehealth
adoption by mental health and substance use
disorder treatment facilities in the covid-19
pandemic.’’ Psychiatric Services (Washington, DC),
73(4), 411–417. https://doi.org/10.1176/
appi.ps.202100191;
362 Hughes, P.M., Verrastro, G., Fusco, C.W.,
Wilson, C.G., & Ostrach, B. (2021). ‘‘An examination
of telehealth policy impacts on initial rural opioid
use disorder treatment patterns during the COVID–
19 pandemic.’’ The Journal of Rural Health, 37(3),
467–472. https://doi.org/10.1111/jrh.12570.
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b. Proposal To Allow OTPs To Use
Audio-Visual Telecommunications for
Initiation of Treatment With Methadone
Prior to the PHE for COVID–19, the
Ryan Haight Online Pharmacy
Consumer Protection Act of 2008 (Pub.
L. 110–425) amended the Controlled
Substances Act and instructed the DEA
to promulgate regulations that required
healthcare providers to conduct an inperson examination in the presence of a
practitioner prior to prescribing
controlled substances (for example,
methadone, buprenorphine, etc.) to
patients, with certain exceptions. These
statutory provisions prevented the
distribution and dispensing of
controlled substances by means of the
internet without at least one in-person
medical evaluation before writing a
prescription. Similarly, SAMHSA
regulations under 42 CFR 8.12(f)(2) have
historically required a complete
physical evaluation before a patient
begins treatment at an OTP. However,
after the declaration of the PHE for
COVID–19, the DEA and SAMHSA
jointly issued flexibilities for
prescribing of controlled substances via
telehealth to ensure patient therapies
would remain accessible. Consequently,
OTPs were exempted from the
requirement to perform an in-person
physical evaluation for any patient who
would be treated by the OTP with
buprenorphine if a program physician,
primary care physician, or an
authorized healthcare professional
under the supervision of a program
physician, determines that an adequate
evaluation of the patient can be
accomplished via telehealth through an
audio-video or audio-only evaluation.363
At the time, this exemption applied
exclusively to patients with an OUD
being treated at an OTP with
buprenorphine, and it did not apply to
new patients initiating treatment with
methadone. This meant that new OTP
patients starting treatment with
methadone would need to still receive
an in-person physical evaluation prior
to the OTP prescribing methadone.
Accordingly, in the CY 2023 PFS final
rule (87 FR 69775 through 69777), we
revised the regulation in paragraph (vi)
of the definition of ‘‘Opioid treatment
services’’ at § 410.67(b) to allow the OTP
intake add-on code to be furnished via
two-way audio-video communications
technology when billed for the initiation
of treatment with buprenorphine, to the
363 https://www.deadiversion.usdoj.gov/GDP/
(DEA-DC-022)(DEA068)DEASAMHSA
buprenorphinetelemedicine(Final)+Esign.pdf;
https://www.samhsa.gov/medications-substanceuse-disorders/statutes-regulations-guidelines/
buprenorphine-at-opioid-treatment-programs.
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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. We stated
that section 1834(m)(7) of the Act allows
telehealth services for the treatment of
a diagnosed SUD or co-occurring mental
health disorder to be furnished to
individuals at any telehealth originating
site, including in a patient’s home, and
that some codes describing new patient
office/outpatient visits are already
under the Medicare Telehealth list (CPT
codes 99202 through 99205). Therefore,
we believed that these changes for the
initiation of treatment with
buprenorphine via audio-only or audiovideo telecommunications would also
be consistent with existing flexibilities
under the PFS. Consistent with
SAMHSA and DEA requirements at the
time of CY 2023 PFS rulemaking, we
also noted that this exemption applied
exclusively to OTP patients treated with
buprenorphine and did not apply to
new patients treated with methadone.
Notably, SAMHSA recently finalized
and codified this flexibility at 42 CFR
8.12(f)(2)(v)(B),364 so that OTPs may use
audio-visual or audio-only platforms
when evaluating patients who are being
admitted for treatment at the OTP with
schedule III medications (such as
buprenorphine) on a permanent basis.
Furthermore, in their recent final rule
published in the Federal Register in
February of 2024 (89 FR 7528),
SAMHSA made reforms to full
examination requirements for initiation
of treatment with methadone at
§ 8.12(f)(2)(v)(A). Specifically, SAMHSA
now allows for audio-visual telehealth
initiation for any new patient who will
be treated by the OTP with methadone
if a practitioner or primary care provider
determines that an adequate evaluation
of the patient can be accomplished via
an audio-visual telehealth platform.
When audio-visual technologies are not
available or their use is not feasible for
a patient, it is acceptable to use audioonly devices, but only when the patient
is in the presence of a licensed
practitioner who is registered to
prescribe (including dispense)
controlled medications. In finalizing
this new flexibility, SAMHSA reasoned
that ‘‘evidence underlying the initiation
364 89 FR 7528, February 2, 2024 (https://
www.federalregister.gov/documents/2024/02/02/
2024-01693/medications-for-the-treatment-ofopioid-use-disorder).
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of buprenorphine using telehealth also
is applicable to the treatment of OUD
with methadone, and warrants
expanding access to methadone therapy
by applying some of the buprenorphine
in-person examination flexibilities to
treatment with methadone in OTPs (89
FR 7533).’’ 365 They also noted that
video-based telehealth was
overwhelmingly supported by
commenters for medical intake, periodic
medical assessments, and methadone or
buprenorphine initiation by OTP
practitioners. SAMHSA did not extend
the flexibility to allow the use of audioonly telehealth platforms in assessing
new patients who will be treated by the
OTP with methadone due to safety
concerns, as they stated ‘‘methadone, in
comparison to buprenorphine, holds a
higher risk profile for sedation in
patients presenting with mild
somnolence which may be easier to
identify through an audio-visual
telehealth platform (89 FR 7533).’’ 366
These new flexibilities to allow new
patients to initiate treatment with
methadone via audio-visual telehealth is
significant, as the majority of patients
who are being treated at an OTP receive
methadone.367 Methadone is used to
treat those with a confirmed diagnosis
of OUD, and is a synthetic opioid
agonist that eliminates withdrawal
symptoms and relieves drug cravings by
acting on opioid receptors in the
brain.368 Methadone has been associated
with reducing the risk of drug overdose,
opioid-related acute care, all-cause
mortality, and opioid-related
mortality.369 It has also been shown to
365 Chan, B., Bougatsos, C., Priest, K.C., McCarty,
D., Grusing, S., & Chou, R. (2022). ‘‘Opioid
treatment programs, telemedicine and COVID–19: A
scoping review.’’ Substance Abuse, 43(1), 539–546.
https://doi.org/10.1080/08897077.2021.1967836.
366 https://www.govinfo.gov/content/pkg/FR2024-02-02/pdf/2024-01693.pdf.
367 American Association for the Treatment of
Opioid Dependence, National Association of State
Alcohol and Drug Abuse Directors, & Opioid
Response Network. (2022). ‘‘Technical Brief: Census
of Opioid Treatment Programs.’’ https://
nasadad.org/wp-content/uploads/2022/12/OTPPatient-Census-Technical-Brief-Final-forRelease.pdf.
368 National Institute on Drug Abuse. (2021,
December). ‘‘How do medications to treat opioid
use disorder work?’’ https://nida.nih.gov/
publications/research-reports/medications-to-treatopioid-addiction/how-do-medications-to-treatopioid-addiction-work.
369 Wakeman, S.E., Larochelle, M.R., Ameli, O.,
Chaisson, C.E., McPheeters, J.T., Crown, W.H.,
Azocar, F., & Sanghavi, D.M. (2020). ‘‘Comparative
effectiveness of different treatment pathways for
opioid use disorder.’’ JAMA Network Open, 3(2),
e1920622. https://doi.org/10.1001/
jamanetworkopen.2019.20622; Sordo, L., Barrio, G.,
Bravo, M.J., Indave, B.I., Degenhardt, L., Wiessing,
L., Ferri, M., & Pastor-Barriuso, R. (2017).
‘‘Mortality risk during and after opioid substitution
treatment: Systematic review and meta-analysis of
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retain patients in treatment, reduce
consequences of injection drug use such
as HIV/Hepatitis C transmission, and
contribute to quality of life
improvements for patients.370 However,
many barriers currently exist for
patients seeking to receive methadone
treatment. Currently, only SAMHSAcertified OTPs can dispense and
administer methadone for the treatment
of OUD as provided under section
303(g)(1) of the Controlled Substances
Act (21 U.S.C. 823(g)(1)) and 42 CFR
part 8. This often means that daily travel
might be necessary if it is determined
that the risks of giving take-home doses
outweigh the benefits, unless patients
are eligible to receive take-home doses
after meeting certain conditions. Most
adults in methadone treatment report at
least one barrier to accessing treatment,
including lack of reliable transportation,
distance from home to treatment, and
work schedule conflicts.371 Frequent
travel to an OTP also disproportionately
impacts rural residents who already face
lower odds of finding an OTP in their
area, and therefore, must spend nearly
2–5 times the amount of average drive
time to access the closest OTP compared
to their urban counterparts.372 Research
cohort studies.’’ The BMJ, 357, j1550. https://
doi.org/10.1136/bmj.j1550; Larochelle, M.R.,
Bernson, D., Land, T., Stopka, T.J., Wang, N., Xuan,
Z., Bagley, S.M., Liebschutz, J.M., & Walley, A.Y.
(2018). ‘‘Medication for opioid use disorder after
nonfatal opioid overdose and association with
mortality: A cohort study.’’ Annals of Internal
Medicine, 169(3), 137. https://doi.org/10.7326/M173107.
370 Mattick, R.P., Breen, C., Kimber, J., & Davoli,
M. (2009). ‘‘Methadone maintenance therapy versus
no opioid replacement therapy for opioid
dependence.’’ Cochrane Database of Systematic
Reviews, 3. https://doi.org/10.1002/
14651858.CD002209.pub2; Bruce, R.D. (2010).
‘‘Methadone as HIV prevention: High volume
methadone sites to decrease HIV incidence rates in
resource limited settings. The International Journal
on Drug Policy, 21(2), 122–124. https://doi.org/
10.1016/j.drugpo.2009.10.004; Alavian, S.M.,
Mirahmadizadeh, A., Javanbakht, M., Keshtkaran,
A., Heidari, A., Mashayekhi, A., Salimi, S., &
Hadian, M. (2013). ‘‘Effectiveness of methadone
maintenance treatment in prevention of hepatitis c
virus transmission among injecting drug users.’’
Hepatitis Monthly, 13(8), e12411. https://doi.org/
10.5812/hepatmon.12411; Carlsen, S.-E.L., Lunde,
L.H., & Torsheim, T. (2019). ‘‘Predictors of quality
of life of patients in opioid maintenance treatment
in the first year in treatment.’’ Cogent Psychology,
6(1), 1565624. https://doi.org/10.1080/
23311908.2019.1565624.
371 Pasman, E., Kollin, R., Broman, M., Lee, G.,
Agius, E., Lister, J.J., Brown, S., & Resko, S. M.
(2022). ‘‘Cumulative barriers to retention in
methadone treatment among adults from rural and
small urban communities.’’ Addiction Science &
Clinical Practice, 17(1), 1–10. https://doi.org/
10.1186/s13722-022-00316-3.
372 Calcaterra, S.L., Bach, P., Chadi, A., Chadi, N.,
Kimmel, S.D., Morford, K.L., Roy, P., & Samet, J. H.
(2019). ‘‘Methadone matters: What the United States
can learn from the global effort to treat opioid
addiction.’’ Journal of General Internal Medicine,
34(6), 1039–1042. https://doi.org/10.1007/s11606-
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has also shown that the number of
missed doses of methadone increases for
residents living longer distances from an
OTP. Additionally, people living with
disabilities are less likely to receive
Medications for Opioid Use Disorder
(MOUDs), and some data also shows
that many SUD treatment programs are
not physically accessible for these
populations.373 The existence of these
physical barriers to accessing
methadone and treatment at OTP
facilities, especially among historically
underserved populations, warrants
additional considerations to the extent
that telehealth flexibilities can mitigate
these barriers to accessing care, as long
as these flexibilities are medically
appropriate and reasonable for the
diagnosis and treatment of OUD.
To be consistent with SAMHSA’s
reforms to telehealth flexibilities for
initiation of treatment with methadone
at § 8.12(f)(2)(B)(v), past conforming
regulations under the Medicare OTP
benefit to allow telecommunication
flexibilities for initiation of treatment
with buprenorphine, and to contribute
towards efforts to reduce barriers in
accessing care for Medicare
beneficiaries seeking treatment with
methadone, we are proposing to make
similar telecommunication flexibilities
under the Medicare OTP benefit.
Specifically, we are proposing to allow
the OTP intake add-on code (HCPCS
code G2076) to be furnished via twoway audio-video communications
technology when billed for the initiation
of treatment with methadone, to the
extent that the use of audio-video
telecommunications technology to
initiate treatment with methadone is
authorized by DEA and SAMHSA at the
time the service is furnished. We note
that under this proposal, the initiation
of treatment with methadone using
telecommunications technology would
be considered an intake activity for
purposes of paragraph (vi) of the
definition of ‘‘Opioid treatment
services’’ at § 410.67(b) only to the
extent that the use of such
telecommunications technology is
018-4801-3; Jehan, S., Zahnd, W.E., Wooten, N.R.,
& Seay, K.D. (2024). ‘‘Geographic variation in
availability of opioid treatment programs across
U.S. communities.’’ Journal of Addictive Diseases,
42(2), 136–146. https://doi.org/10.1080/
10550887.2023.2165869.
373 Thomas, C.P., Stewart, M.T., Ledingham, E.,
Adams, R.S., Panas, L., & Reif, S. (2023). ‘‘Quality
of opioid use disorder treatment for persons with
and without disabling conditions.’’ JAMA Network
Open, 6(3), e232052. https://doi.org/10.1001/
jamanetworkopen.2023.2052; West, S.L. (2007).
‘‘The accessibility of substance abuse treatment
facilities in the United States for persons with
disabilities.’’ Journal of Substance Abuse
Treatment, 33(1), 1–5. https://doi.org/10.1016/
j.jsat.2006.11.001.
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permitted under the applicable DEA and
SAMHSA regulations and guidance at
the time the services are furnished.
However, at this time, we are not
proposing to extend the flexibility to
allow the use of audio-only
telecommunications for intake activities
described in paragraph (vi) of the
definition of ‘‘Opioid treatment
services’’ at § 410.67(b) for initiation of
treatment with methadone, as these
flexibilities are not currently permitted
by SAMHSA and the DEA. We
recognize that methadone is
characterized as a schedule II controlled
substance, which means that it still has
higher potential for misuse with
potential physical dependence.374
Unlike buprenorphine that is a schedule
III controlled substance, methadone is a
full agonist and does not have a ‘‘ceiling
effect,’’ which provides more protective
overdose factors when taking additional
doses of the drug.375 Thus, use of audiovisual telecommunications for initiation
of treatment with methadone would
balance potential safety concerns
associated with methadone, such as its
higher potential for misuse and risk for
sedation in patients presenting with
mild somnolence which may be easier
to identify via a audio-visual telehealth
platform, while still allowing patients
the flexibility of initiating treatment via
(audio-visual) telehealth at an OTP.
We believe that this proposal may
meaningfully improve access to care,
promote positive health outcomes, and
advance health equity among Medicare
beneficiaries. Data indicate that
expanded use of telehealth and
flexibilities for the provision of MOUD
during the COVID–19 pandemic was
associated with improved care retention
and a reduction in medically treated
overdoses among Medicare
beneficiaries.376 Similarly, telehealth
initiation for buprenorphine to treat
OUD was associated with improved
treatment retention in a subset of U.S
states.377 Other research has not found
374 https://www.dea.gov/drug-information/drugscheduling.
375 Whelan, P.J., & Remski, K. (2012).
‘‘Buprenorphine vs methadone treatment: A review
of evidence in both developed and developing
worlds.’’ Journal of Neurosciences in Rural Practice,
3(1), 45–50. https://doi.org/10.4103/09763147.91934.
376 Jones, C.M., Shoff, C., Hodges, K., Blanco, C.,
Losby, J.L., Ling, S.M., & Compton, W.M. (2022).
‘‘Receipt of telehealth services, receipt and
retention of medications for opioid use disorder,
and medically treated overdose among Medicare
beneficiaries before and during the covid–19
pandemic.’’ JAMA Psychiatry, 79(10), 981–992.
https://doi.org/10.1001/jamapsychiatry.2022.2284.
377 Hammerslag, L.R., Mack, A., Chandler, R.K.,
Fanucchi, L.C., Feaster, D.J., LaRochelle, M.R.,
Lofwall, M.R., Nau, M., Villani, J., Walsh, S.L.,
Westgate, P.M., Slavova, S., & Talbert, J.C. (2023).
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significant differences in clinical
severity and complexity markers (for
example, OUD-related emergency
department visits) between patients
receiving telemedicine inductions into
treatment versus in-person
examinations,378 suggesting that quality
of care can be maintained through
initiation of treatments via telehealth.
Thus, many of these benefits associated
with telehealth flexibilities for initiating
treatment with other MOUDs can be
potentially replicated by allowing
initiation of treatment with methadone
via audio-visual telecommunications.
Additionally, we believe this proposal
would meaningfully impact health
equity. Individuals from Black,
American Indian and Alaska Native,
and Hispanic populations are
significantly less likely to initiate
treatment for a SUD, as well as
individuals from economically
disadvantaged communities.379 Despite
these disparities, during the COVID–19
pandemic, the odds of initiating
treatment for a SUD increased for most
age, race, ethnicity, and socioeconomic
status subgroups, which may have been
explained by increases in treatment
initiation occurring through
telehealth.380 Thus, promoting
flexibilities for telecommunication
modalities of treatment initiation in
regards to methadone may provide
additional options for accessing
treatment, especially for populations
who often experience barriers in
beginning treatment. Lastly, we believe
this proposal is in alignment with the
HHS Overdose Prevention Strategy,
which aims to broaden access to
evidence-based care that increases
willingness to engage and remain in
treatment.381 Similarly, this proposal
‘‘Telemedicine buprenorphine initiation and
retention in opioid use disorder treatment for
Medicaid enrollees.’’ JAMA Network Open, 6(10),
e2336914. https://doi.org/10.1001/
jamanetworkopen.2023.36914.
378 Barsky, B.A., Busch, A.B., Patel, S.Y.,
Mehrotra, A., & Huskamp, H.A. (2022). ‘‘Use of
telemedicine for buprenorphine inductions in
patients with commercial insurance or Medicare
advantage.’’ JAMA Network Open, 5(1), e2142531.
https://doi.org/10.1001/
jamanetworkopen.2021.42531.
379 Acevedo, A., Panas, L., Garnick, D., AcevedoGarcia, D., Miles, J., Ritter, G., & Campbell, K.
(2018). ‘‘Disparities in the treatment of substance
use disorders: Does where you live matter?’’. The
Journal of Behavioral Health Services & Research,
45(4), 533–549. https://doi.org/10.1007/s11414-0189586-y.
380 Palzes, V.A., Chi, F.W., Metz, V.E., Sterling, S.,
Asyyed, A., Ridout, K.K., & Campbell, C.I. (2023).
‘‘Overall and telehealth addiction treatment
utilization by age, race, ethnicity, and
socioeconomic status in California after covid–19
policy changes.’’ JAMA Health Forum, 4(5),
e231018. https://doi.org/10.1001/
jamahealthforum.2023.1018.
381 https://www.hhs.gov/overdose-prevention/.
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would further the goals of the National
Drug Control Strategy, which strives to
expand policies that improve SUD
treatment engagement by lowering
various barriers to enter and participate
in treatment, such as through
telemedicine treatment initiation.382
Accordingly, we are proposing to
revise the regulations for intake
activities at paragraph (vi) within the
definition of ‘‘opioid use disorder
treatment service’’ at § 410.67(b). We are
proposing to add a new paragraph
(vi)(A) within the description of intake
activities to separately list flexibilities
for intake activities furnished via
communications technology, and we are
proposing to add and reserve a new
paragraph (vi)(B). We are proposing to
move the language related to the
existing flexibilities for the initiation of
treatment with buprenorphine to
paragraph (vi)(A)(1). Additionally, in
the definition of ‘‘opioid use disorder
treatment service’’ at § 410.67(b), we are
proposing to codify telecommunications
flexibilities for initiation of treatment
with methadone at paragraph (vi)(A)(2).
Specifically, we propose that services to
initiate treatment with methadone may
be furnished via two-way interactive
audio-video communication technology,
as clinically appropriate, and in
compliance with all applicable
requirements, if an OTP determines that
an adequate evaluation of the patient
can be accomplished through audiovideo communication technology. We
look forward to comments related to this
proposal.
3. Proposals Related to Reforms to 42
CFR Part 8
In the CY 2020 PFS final rule, we
implemented payment and coverage for
opioid use disorder treatment services,
including services such as substance use
counseling by a professional to the
extent authorized under State law to
furnish such services, individual and
group therapy with a physician,
psychologist (or other mental health
professional to the extent authorized
under State law), and other items and
services that the Secretary determines
are appropriate (but in no event to
include meals or transportation), as
authorized by section 1861 of the Act
(84 FR 62630 through 62677 and 84 FR
62919 through 62926). Consequently,
we included these services within the
definition of OUD treatment services at
§ 410.67(b) and incorporated payment
for these services as part of the non-drug
component at § 410.67(d)(2)(ii). We also
382 https://www.whitehouse.gov/wp-content/
uploads/2022/04/National-Drug-Control2022Strategy.pdf.
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created an add-on code described by
HCPCS code G2080 to reflect an
additional 30 minutes of counseling or
individual or group therapy provided in
a week. We further finalized additional
adjustments to the bundled payment for
an episode of care, such as intake
activities and periodic assessments. At
the time, we noted that both initial and
periodic assessments are required under
SAMHSA regulations, and that they
were integral services for the
establishment and maintenance of OUD
treatment for a beneficiary at an OTP (84
FR 62634). We codified definitions of
these services within the definition of
OUD treatment services at § 410.67(b); at
paragraph (vi), we stated that intake
activities include initial medical
examination services required under 42
CFR 8.12(f)(2) and initial assessment
services required under § 8.12(f)(4); at
paragraph (vii) we stated that periodic
assessment services include those
required under § 8.12(f)(4). Services
under § 8.12(f) are required services as
part of Federal opioid treatment
standards for OTPs, as regulated by
SAMHSA. Accordingly, we created
HCPCS code G2076 [Intake activities,
including initial medical examination
that is a complete, fully documented
physical evaluation and initial
assessment conducted by a program
physician or a primary care physician,
or an authorized healthcare
professional under the supervision of a
program physician or qualified
personnel that includes preparation of a
treatment plan that includes the
patient’s short-term goals and the tasks
the patient must perform to complete
the short-term goals; the patient’s
requirements for education, vocational
rehabilitation, and employment; and the
medical, psycho-social, economic, legal,
or other supportive services that a
patient needs, conducted by qualified
personnel (provision of the services by a
Medicare-enrolled Opioid Treatment
Program); List separately in addition to
code for primary procedure], and code
G2077 [Periodic assessment; assessing
periodically by qualified personnel to
determine the most appropriate
combination of services and treatment
(provision of the services by a Medicareenrolled Opioid Treatment Program);
List separately in addition to code for
primary procedure] in order to have a
mechanism to make payment under
Medicare to OTPs for these required
services. In the CY 2021 and CY 2022
PFS final rules (85 FR 84682 through
84690; 86 FR 65338 through 65341), we
also established payment for take-home
supplies of naloxone and overdose
education furnished in conjunction with
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providing an opioid antagonist
medication.
Additionally, in the CY 2020 PFS
final rule, we codified requirements
specified in the section 1861(jjj)(2) of
the Act for OTPs. Specifically, we
defined an ‘‘opioid treatment program’’
at § 410.67(b) as an entity that is an OTP
as defined in § 8.2 (or any successor
regulation) that meets the applicable
requirements for an OTP. For an OTP to
participate and receive payment under
the Medicare program, the OTP must be
enrolled in Medicare under section
1866(j) of the Act, have in effect a
certification by SAMHSA for such a
program, and be accredited by an
accrediting body approved by
SAMHSA. Lastly, an OTP must meet
additional conditions as the Secretary
may find necessary to ensure the health
and safety of individuals being
furnished services under such program
and the effective and efficient
furnishing of such services.
Recently, SAMHSA issued a new final
rule (89 FR 7528), which made major
reforms to 42 CFR part 8, governing
requirements for OTPs in providing
medications for the treatment of OUD
and many other services. The rule
provides significant refinements, as 42
CFR part 8 was published over 21 years
ago, by reflecting new paradigms of care
for OUD that have become increasingly
patient-centered and evidence-based.
The regulatory reforms for opioid
treatment standards reflect an
understanding that OUD is a chronic
condition, and to be successful,
treatment interventions should be
individualized and include harm
reduction and recovery support
services, among other services.383
Consequently, SAMHSA redefined
comprehensive treatment at § 8.2 to
specify that treatment at OTPs includes
‘‘the continued use of MOUD provided
in conjunction with an individualized
range of appropriate harm reduction,
medical, behavioral health, and
recovery support services.’’ At the same
time, SAMHSA constructed a new
definition of harm reduction services at
§ 8.2. In particular, harm reduction
‘‘refers to practical, evidence-based
strategies, including: overdose
education; testing and intervention for
infectious diseases including counseling
and risk mitigation activities forming
part of a comprehensive, integrated
approach to address human
immunodeficiency virus (HIV), viral
hepatitis, sexually transmitted
383 89 FR 7528, February 2, 2024 (https://
www.federalregister.gov/documents/2024/02/02/
2024–01693/medications-for-the-treatment-ofopioid-use-disorder).
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infections, and bacterial and fungal
infections; distribution of opioid
overdose reversal medications; linkage
to other public health services; and
connecting those who have expressed
interest in additional support to peer
services.’’ Harm reduction approaches
are especially important to reduce
certain health and safety issues
associated with drug use through care
that is intended to be free of stigma and
centered on the needs of people who
use drugs. Decades of research have
shown that harm reduction strategies
provide significant benefits in
preventing drug overdose deaths and
transmission of infectious diseases
among those who use drugs, educate
individuals and community members
about reducing the negative
consequences associated with drug use,
and link individuals to SUD treatment
and other recovery resources.384 Harm
reduction is also a crucial component of
the HHS Overdose Prevention Strategy,
which aims to promote evidence-based
harm reduction services, including
those that are integrated within
healthcare delivery, and to expand
sustainable funding strategies for harm
reduction services.385 Besides defining
harm reduction, SAMHSA also finalized
a new definition for ‘‘recovery support
services’’ at § 8.2. Specifically, recovery
is the process of change through which
people improve their health and
wellness, live self-directed lives, and
strive to reach their full potential.
Recovery support services can include,
but are not limited to, community-based
recovery housing, peer recovery support
services, social support, linkage to and
coordination among allied service
providers and a full range of human
services that facilitate recovery and
wellness contributing to an improved
quality of life. The services extend the
continuum of care by strengthening and
complementing substance use disorder
(SUD) treatment interventions in
different settings and stages. Recovery
support services are a vital part SUD
treatment, as they take into account the
relapsing and chronic nature of a SUD,
and emphasize the need for continuous
care to keep individuals engaged in
treatment, especially along different
stages of recovery.386 Recovery support
384 https://www.cdc.gov/overdose-prevention/
php/od2a/harm-reduction.html. https://
nida.nih.gov/research-topics/harm-reduction.
385 https://www.hhs.gov/overdose-prevention/
harm-reduction.
386 Stanojlović, M., & Davidson, L. (2021).
‘‘Targeting the barriers in the substance use
disorder continuum of care with peer recovery
support.’’ Substance Abuse: Research and
Treatment, 15, 117822182097698. https://doi.org/
10.1177/1178221820976988; https://
www.samhsa.gov/find-help/recovery.
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services are also a component of the
HHS Overdose Prevention Strategy,
which recognizes that treatment alone
may not be enough to support long-term
recovery, and that enabling access to
quality integrated and coordinated
recovery support services is important
to prevent drug overdoses.387
Furthermore, SAMHSA made updates
to existing definitions that include some
of the services currently covered under
the Medicare OTP benefit. For example,
a psychoeducational service element
was added to the definition of
counseling services at § 8.12(f)(5), so
that both counseling and
psychoeducational services would also
include harm reduction education and
recovery-oriented counseling. New
guidelines on counseling related to
preventing exposure to and
transmission of various infectious
diseases were also added. As part of
these services, at § 8.12(f)(5)(iii), OTPs
also must continue to provide directly,
or through referral to adequate and
reasonably accessible community
resources, vocational training,
education, and employment services for
patients who request such services or
for whom these needs have been
identified and mutually agreed-upon as
beneficial by the patient and program
staff. Notably, SAMHSA also made
updates to their descriptions of initial
and periodic assessment activities at
§ 8.12(f)(4), which initially informed the
definitions of intake activities and
periodic assessments in the definition of
‘‘OUD treatment services’’ at § 410.67(b)
and the creation of codes describing
these services (HCPCS codes G2076 and
G2077) when CMS first implemented
the Medicare OTP benefit in the CY
2020 PFS final rule. When introducing
these changes in their proposed rule in
December 2022 (87 FR 77330),
SAMHSA noted that ‘‘changes to the
initial and periodic medical services
sections are intended to promote key
issues for OTP medical practitioners
and the OTP multi-disciplinary team to
address with a patient as part of
treatment. This includes areas that may
increase the risk of a patient leaving
care prematurely, such as unmet mental
health or other disability, medical and
oral health needs, the need for
culturally supportive care that addresses
race, ethnicity, sexual orientation,
religion or gender identity, and social
determinants of health, such as housing
and transportation, that may pose
barriers to treatment engagement, or
harm reduction and recovery support
service needs.’’ New changes to the
387 https://www.hhs.gov/overdose-prevention/
recovery-support.
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definition of initial assessments now
include patient-centered language
regarding the need for care plans to
include the patient’s goals and mutually
agreed-upon actions for the patient to
meet those goals, and new references are
added for harm reduction interventions
and recovery support services to be
included as components of care plans if
a patient needs and wishes to pursue
these services. For example, patientcentered care plans developed during
initial assessments may reflect a
‘‘patient’s goals and mutually agreedupon actions for the patient to meet
those goals, including harm reduction
interventions; the patient’s needs and
goals in the areas of education,
vocational training, and employment;
and the medical and psychiatric,
psychosocial, economic, legal, housing,
and other recovery support services that
a patient needs and wishes to pursue
(89 FR 73558).’’ Lastly, regarding
periodic assessment services at
§ 8.12(f)(4)(ii), SAMHSA requires that
these examinations should occur not
less than one time each year and be
conducted by an OTP practitioner. The
periodic physical examination should
include review of MOUD dosing,
treatment response, other SUD
treatment needs, responses and patientidentified goals, and other relevant
physical and psychiatric treatment
needs and goals. The periodic physical
examination should be documented in
the patient’s clinical record. In whole,
these regulatory changes largely reflect
significant changes in evidence-based
practice and towards patient-centered
care in the treatment of OUD that have
occurred in the past couple of decades,
including considerations of the need to
address unmet health related social
needs (HRSN) that impose barriers on a
patient’s ability to initiate, engage, and
remain in treatment, including in areas
of education, employment, and housing
as well as in harm reduction strategies
that decrease the negative consequences
associated with a patient’s use or abuse
of opioids, and recovery support
services that address the chronic nature
of OUD and the need for supports across
the full continuum of care.
In addition to these reforms to opioid
treatment standards at 42 CFR part 8,
there have been recent activities under
the PFS, and through other CMS
programs, that have addressed the social
determinants of health (SDOH), which
often affect the diagnosis and treatment
of a patient’s medical problem. Healthy
People 2030, which is a 10-year HHS
initiative to identify public health
priorities that help individuals,
organizations, and communities across
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the U.S improve health and wellbeing,388 defines the SDOH, as 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.’’ 389
SDOH include many domains that
largely impact health, including
economic stability, education,
healthcare, the neighborhood and built
environment, and social and community
context. Some studies have estimated
that SDOH can affect as much as 50
percent of the variation in health
outcomes compared to clinical care
impacting only 20 percent.390 For
example, individuals with a higher
income have been found to exhibit
lower mortality, higher life expectancy,
and slower declines in physical
mobility; individuals who lack
insurance are less likely to obtain
necessary medical care and prescription
medications; and, food insecurity is
associated with higher rates of birth
defects, cognitive problems,
hospitalization rates, asthma, and
behavioral health problems.391
Moreover, SDOH act as structural and
contextual factors that shape the
conditions impacting health, and their
unequal distribution impacts the
development of HRSNs at the individual
level, which refer to an individual’s
needs that might include housing,
healthy foods, transportation, financial
assistance, etc. An inability to address
these HRSNs put individuals at a higher
risk for exacerbating health conditions,
and it is a major driver of health
inequities.392 Health equity is the
388 https://health.gov/healthypeople/
about#:∼:text=What%20is%20Healthy%
20People%20202030,over%20the%20first%204%
decades.
389 https://health.gov/healthypeople/priorityareas/social-determinants-health.
390 Whitman, A., Chapell, A., Aysola, V.,
Zuckerman, R., & Sommers, B. (2022). ‘‘Addressing
Social Determinants of Health: Examples of
Successful Evidence-Based Strategies and Current
Federal Efforts’’ (ASPE, Office of Health Policy HP–
2022–12). https://aspe.hhs.gov/sites/default/files/
documents/e2b650cd64cf84aae8ff0fae7474af82/
SDOH-Evidence-Review.pdf; Hood, C. M., Gennuso,
K. P., Swain, G. R., & Catlin, B. B. (2016). ‘‘County
health rankings: Relationships between determinant
factors and health outcomes.’’ American Journal of
Preventive Medicine, 50(2), 129–135. https://
doi.org/10.1016/j.amepre.2015.08.024.
391 National Academies of Sciences, E., Medicine,
N. A. of, Nursing 2020–2030, C. on the F. of,
Flaubert, J. L., Menestrel, S. L., Williams, D. R., &
Wakefield, M. K. (2021). ‘‘Social determinants of
health and health equity. In The Future of Nursing
2020–2030: Charting a Path to Achieve Health
Equity.’’ National Academies Press (U.S.). https://
www.ncbi.nlm.nih.gov/books/NBK573923/.
392 Whitman, A., Chapell, A., Aysola, V.,
Zuckerman, R., & Sommers, B. (2022). ‘‘Addressing
Social Determinants of Health: Examples of
Successful Evidence-Based Strategies and Current
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attainment of the highest level of health
for all people, where everyone has a fair
and just opportunity to attain their
optimal health regardless of race,
ethnicity, disability, sexual orientation,
gender identity, socioeconomic status,
geography, preferred language, or other
factors that affect access to care and
health outcomes, which is complicated
by SDOH such as poverty, unequal
access to healthcare, lack of education
or employment, stigma, and
discrimination.393 Therefore, in light of
decades of research showing that these
upstream factors drive health outcomes,
and evidence suggesting interventions
in healthcare settings that address social
needs can improve the treatment of an
individual’s condition, CMS recently
finalized coding and payment for SDOH
risk assessments in the CY 2024 PFS
final rule (88 FR 78932). HCPCS code
G0136 describes SDOH risk assessments
(Administration of a standardized,
evidence-based Social Determinants of
Health Risk Assessment, 5–15 minutes,
not more often than every 6 months)
that may be billed when practitioners
spend time and resources assessing
HRSNs that interfere with the
practitioner’s ability to diagnose or treat
the patient. These assessments, which
may also be provided during a
behavioral health visit, are often
administered as part of an assessment of
patient histories, risk, and in informing
medical decision-making around the
care and treatment of the disease or
illness. They are often accomplished
through the use of a standardized
evidence-based tool that include the
domains of food insecurity, housing
insecurity, transportation needs, and
utility difficulties. Besides establishing
standalone payment for SDOH risk
assessments, in the CY 2024 PFS final
rule, CMS also created coding and
payment for community health
integration (CHI) (HCPCS codes G0019
& G0022) and principal illness
navigation services (PIN) (HCPCS codes
G0023, G0024, G0140, and G0146). Both
CHI and PIN services involve a personcentered assessment to better
understand the patient’s life story, care
coordination, contextualizing health
education, building patient selfadvocacy skills, health system
navigation, facilitating behavioral
change, providing social and emotional
support, and facilitating access to
community-based social services (for
Federal Efforts’’ (ASPE, Office of Health Policy HP–
2022–12). https://aspe.hhs.gov/sites/default/files/
documents/e2b650cd64cf84aae8ff0fae7474af82/
SDOH-Evidence-Review.pdf.; https://
www.whitehouse.gov/wp-content/uploads/2023/11/
SDOH-Playbook-3.pdf.
393 https://www.cms.gov/pillar/health-equity.
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example, housing, utilities,
transportation, food assistance) to
address unmet SDOH needs. The
services described by the CHI codes
address unmet SDOH needs that affect
the diagnosis and treatment of the
patient’s medical problems. PIN services
focus on Medicare beneficiaries
diagnosed with high-risk conditions (for
example, dementia, HIV/AIDS, and
cancer) in order to identify and connect
them with appropriate clinical and
support resources.
Moreover, many of these
aforementioned services, including
harm reduction interventions, recovery
support services, addressing HRSN, and
facilitating access to community-based
social services to address these needs,
ordinarily occur in OTP settings. In
2022, approximately 92 percent of OTP
facilities offered various recovery
support services, including peer support
(59.6 percent), assistance locating
housing for clients (75.0 percent),
employment counseling (49.5 percent),
and assistance helping patients obtain
social services (81.2 percent). The
majority of OTPs also offered various
types of harm reduction services,
including testing for various types of
infectious diseases (>55 percent), health
education (>77%), and naloxone and
overdose education (92.3 percent).
Many OTPs also conduct community
outreach services to those in need of
OUD treatment (76.1 percent) and case
management services (87.8 percent).394
Additionally, as part of initial and
periodic assessment services at
§ 8.12(f)(4), OTPs must designate in the
care plan a patient’s needs and goals in
the areas of harm reduction
interventions, education, vocational
training, and employment, along with
the medical and psychiatric,
psychosocial, economic, legal, housing,
and other recovery support services that
a patient needs and wishes to pursue,
which all reflect consideration to
various health-related social needs. The
new definitions of harm reduction and
recovery support services at § 8.2 are
also inclusive of activities that involve
linkage to and coordination with
providers that address a full range of
human and public health services to
facilitate recovery and wellness for a
SUD. Lastly, in the CY 2020 PFS final
rule we responded to public comments
pertaining to the above-mentioned
activities. Specifically, several
commenters stated that OTPs often
394 Table SU17b: Substance use treatment
facilities, by services provided and facility type:
Number and column percent, 2022: https://
www.samhsa.gov/data/sites/default/files/reports/
rpt42714/NSUMHSS-Annual-Detailed-Tables22.pdf.
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provide case management and/or care
management services and requested that
CMS consider reimbursing for these
services either as part of the standard
bundle or as an adjustment to the
bundled payment, as applicable. A few
commenters stated that OTPs serve as a
fixed point of responsibility in the
provision of whole person-centered care
and improving health outcomes through
collaborative arrangements with health
care providers outside of the OTP and
that the goal of care management is to
reduce health care costs, specifically
preventable hospital admissions,
readmissions, and avoidable emergency
room visits. The commenters also stated
in the CY 2020 final rule that OTP staff
also help patients with accessing food
benefits, housing, and employment
searches, which are critical components
for sustained recovery, as part of the
goal of complete case management (84
FR 62648). At the time, CMS stated that
we would consider making payment for
these type of care management activities
for future rulemaking, including
activities whereby OTPs collaborate
with providers outside the OTPs to help
patients access social services. We
believed it was appropriate to work with
OTPs to better understand how these
services are furnished in an OTP setting,
as well as to continue to look at data on
specific items and services that may fit
within the scope of OUD treatment
services.
a. Proposal To Establish Payment for
Social Determinants of Health Risk
Assessments
The recent refinements to initial
assessments under § 8.12(f)(4)(i) likely
necessitate additional resource costs for
OTPs in order to comply with the
opioid treatment standards for assessing
various SDOHs (for example, education,
vocational training, employment,
economic, legal, housing, etc.) that
impact a patient’s HRSNs, and to
identify a patient’s goals for harm
reduction interventions and needs for
recovery support services as they relate
to the treatment of an OUD. We
recognize that the paradigm for OUD
treatment and care has evolved rapidly
since the implementation of the
Medicare OTP benefit in CY 2020, and
that providers have increasingly
incorporated interventions to address
HRSNs that increase the risk of a patient
leaving OUD treatment prematurely or
that pose barriers to treatment
engagement. We additionally
acknowledge that coding already exists
under the PFS that accounts for the
resources involved in conducting these
types of assessments. For these reasons,
we are proposing to establish payment
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for SDOH risk assessments as part of
intake activities within OUD treatment
services, as long as these assessments
are medically reasonable and necessary
for the diagnosis or treatment of an
OUD, and OTPs have a reason to believe
unmet HRSNs or the need for harm
reduction intervention or recovery
support services identified during such
an assessment could interfere with the
OTP’s ability to diagnose or treat the
patient’s OUD. As previously stated, the
SDOH include broad structural and
contextual domains that may impact
health (for example, economic stability,
education, healthcare, neighborhood
and built environment, and social and
community context) and the
development of HRSNs at the
individual-level (for example, housing
and utilities assistance, transportation
assistance, financial assistance, healthy
foods, personal safety, employment,
recovery support and harm reduction
services). We understand that there are
multiple standardized, evidence-based
SDOH risk-assessment tools utilized
across the healthcare system that are
structured to assess a patient across
various SDOH domains.395 If an OTP
furnishes SDOH risk assessments as part
of initial assessments under
§ 8.12(f)(4)(i), we would expect that the
assessment tools used would allow the
OTP to identify more specific
individual-level HRSNs as part of the
care plan, including giving
consideration to potential harm
reduction and recovery support services
needs.
Specifically, we are proposing to
update the payment rate for intake
activities described by HCPCS code
G2076 by adding in the value of the
non-facility rate for SDOH risk
assessments described by HCPCS code
(G0136). We believe HCPCS code G0136
may serve as a reasonable proxy to
reflect the value and resources required
for the type of assessment service
activities that OTPs are required to
provide according to SAMHSA
requirements under § 8.12(f)(4)(i),
including an assessment to identify a
patient’s unmet HRSNs or the need for
harm reduction intervention and
recovery support services that are
critical to the treatment of an OUD. We
understand that OTPs have been
involved in collaborative agreements
with organizations who address HRSN
sand offer various recovery support
services (84 FR 62648), and we believe
that for OTPs to appropriately identify
395 https://prapare.org/wp-content/uploads/2021/
10/What-is-PRAPARE_2.1.21-1.pdf; https://
www.cms.gov/priorities/innovation/media/
document/ahcm-screeningtool-companion.
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these types of organizations that target
a specific need, identifying these HRSNs
as part of SDOH risk assessments is
likely needed prior to engaging in
activities to coordinate service delivery.
However, we seek comment on whether
these types of SDOH assessments
ordinarily complement the type of
community coordination activities that
OTPs perform.
Establishing payment to account for
SDOH risk assessments as part of intake
activities under the OTP benefit is
important, as unmet HRSNs identified
as part of such assessments significantly
impact outcomes for OUD treatment.
Evidence shows that healthcare
providers who screen for SDOH in their
settings have found that patients who
screen positive for a HRSN were
significantly more likely to have a
history of substance use or mental
illness compared to patients who did
not have an HRSN.396 For example, one
review found that between 50 to 90
percent of patients in publicly funded
OTPs were unemployed, and that older
adults identified to have misused
opioids were 22-percent less likely to be
employed.397 Patients with an OUD are
also more likely to have a lower
educational attainment, encounter
financial hardship, and housing
instability.398 Even more, food
insecurity has been indicated to be a
strong predictor of prescription opioid
misuse and abuse.399 The SDOH and
their contribution to unmet HRSNs have
also heavily impacted the rates of drug
396 Chukmaitov, A., Dahman, B., Garland, S.L.,
Dow, A., Parsons, P.L., Harris, K.A., & Sheppard,
V.B. (2022). ‘‘Addressing social risk factors in the
inpatient setting: Initial findings from a screening
and referral pilot at an urban safety-net academic
medical center in Virginia, USA.’’ Preventive
Medicine Reports, 29, 101935. https://doi.org/
10.1016/j.pmedr.2022.101935.
397 Zanis, D.A., & Coviello, D. (2001). ‘‘A case
study of employment case management with
chronically unemployed methadone maintained
clients.’’ Journal of Psychoactive Drugs, 33(1), 67–
73. https://doi.org/10.1080/
02791072.2001.10400470; Albright, D.L., Johnson,
K., Laha-Walsh, K., McDaniel, J., & McIntosh, S.
(2021). ‘‘Social determinants of opioid use among
patients in rural primary care settings.’’ Social Work
in Public Health, 36(6), 723–731. https://doi.org/
10.1080/19371918.2021.1939831.
398 Albright, D.L., Johnson, K., Laha-Walsh, K.,
McDaniel, J., & McIntosh, S. (2021). ‘‘Social
determinants of opioid use among patients in rural
primary care settings.’’ Social Work in Public
Health, 36(6), 723–731. https://doi.org/10.1080/
19371918.2021.1939831; Arsene, C., Na, L., Patel,
P., Vaidya, V., Williamson, A.A., & Singh, S. (2023).
‘‘The importance of social risk factors for patients
diagnosed with opioid use disorder.’’ Journal of the
American Pharmacists Association, 63(3), 925–932.
https://doi.org/10.1016/j.japh.2023.02.016.
399 Men, F., Fischer, B., Urquia, M.L., & Tarasuk,
V. (2021). ‘‘Food insecurity, chronic pain, and use
of prescription opioids.’’ SSM—Population Health,
14, 100768. https://doi.org/10.1016/
j.ssmph.2021.100768.
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overdoses. For example, one study
examined 28 different SDOH measures
that collectively explained 89-percent of
the variance in drug-overdose mortality
across states.400 Housing insecurity, in
particular, negatively affects the
population with an OUD, as this risk
factor has been increasing over time
among those seeking treatment with an
OUD.401 One analysis conducted by the
State of Massachusetts has revealed
alarming evidence that the risk of death
from an opioid overdose is 30-times
higher for those who have experienced
homelessness.402 Lower median
household income and unemployment
have also been associated with an
increase in opioid death rates.403
Moreover, unmet HRSNs have also
hampered access to treatment among
Medicare beneficiaries with a SUD, as
evidence has shown that among
Medicare beneficiaries with an SUD
who were not receiving treatment, onethird reported financial barriers and
one-fifth reported logistical barriers
such as lack of access to transportation
as rationales for not receiving
treatment.404 Lastly, many of these
SDOH factors have impaired treatment
retention and completion rates. Those
with lower levels of educational
attainment and who are unemployed are
less likely to complete SUD treatment,
and individuals who are experiencing
homelessness are significantly less
likely to remain in treatment.405
400 Cesare, N., Lines, L.M., Chandler, R., Gibson,
E.B., Vickers-Smith, R., Jackson, R., Bazzi, A.R.,
Goddard-Eckrich, D., Sabounchi, N., Chisolm, D.J.,
Vandergrift, N., & Oga, E. (2024). ‘‘Development and
validation of a community-level social determinants
of health index for drug overdose deaths in the
HEALing Communities Study.’’ Journal of
Substance Use and Addiction Treatment, 157,
209186. https://doi.org/10.1016/j.josat.2023.209186.
401 Sulley, S., & Ndanga, M. (n.d.). ‘‘Inpatient
opioid use disorder and social determinants of
health: A nationwide analysis of the national
inpatient sample (2012–2014 and 2016–2017).’’
Cureus, 12(11), e11311. https://doi.org/10.7759/
cureus.11311.
402 https://www.mass.gov/files/documents/2017/
08/31/legislative-report-chapter-55-aug-2017.pdf.
403 Rangachari, P., Govindarajan, A., Mehta, R.,
Seehusen, D., & Rethemeyer, R.K. (2022). ‘‘The
relationship between Social Determinants of Health
(Sdoh) and death from cardiovascular disease or
opioid use in counties across the United States
(2009–2018).’’ BMC Public Health, 22(1), 236.
https://doi.org/10.1186/s12889–022–12653–8
Hollingsworth, A., Ruhm, C.J., & Simon, K. (2017).
Macroeconomic conditions and opioid abuse
(Working Paper 23192). National Bureau of
Economic Research. https://doi.org/10.3386/
w23192.
404 Parish, W. J., Mark, T.L., Weber, E.M., &
Steinberg, D.G. (2022). ‘‘Substance use disorders
among Medicare beneficiaries: Prevalence, mental
and physical comorbidities, and treatment
barriers.’’ American Journal of Preventive Medicine,
63(2), 225–232. https://doi.org/10.1016/
j.amepre.2022.01.021.
405 Mennis, J., & Stahler, G. J. (2016). Racial and
ethnic disparities in outpatient substance use
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Therefore, screening for the SDOH and
identifying these unmet HRSNs as part
of intake assessments may help OTPs
link patients with an identified social
need to appropriate resources that can
impact the diagnosis of an OUD or
address barriers to treating an OUD.
As previously stated above, we are
proposing to update the adjustment to
the bundled payment for an episode of
care for intake activities (G2076) by
adding in the value of the non-facility
rate for SDOH risk assessments (G0136:
Administration of a standardized,
evidence-based Social Determinants of
Health Risk Assessment, 5–15 minutes,
not more often than every 6 months),
which is currently assigned a nonfacility rate of $18.66 under the PFS.
Currently, the CY 2024 payment rate for
the intake add-on code (G0276) is
$201.73 and adding the value of a
crosswalk to the CY 2024 non-facility
rate of $18.66 would result in a payment
rate of approximately $220.39. We
believe that incorporating the value of
G0136 into the intake activities
adjustment would be the most
appropriate, as we believe assessment
activities related to SDOH are more
likely to occur during intake
assessments when a new patient is
admitted to an OTP. SAMHSA
treatment guidelines recommend that
during initial screenings, OTPs should
identify barriers and medical and
psychosocial risk-factors that may
hinder a patient’s ability to meet
treatment requirements, including cooccurring health conditions, and
vocational, legal, financial,
transportation, and family concerns.406
We note that intake activities (G2076)
should only be billed for new patients
(that is, patients starting treatment at the
OTP), and since SDOH risk assessments
would be bundled into the code
describing intake activities, this billing
requirement would similarly apply.
However, we seek comment on the
frequency with which these SDOH risk
assessments occur, and whether it
would be more appropriate if these
assessments occur when OTPs furnish
disorder treatment episode completion for different
substances. Journal of Substance Abuse Treatment,
63, 25–33. https://doi.org/10.1016/
j.jsat.2015.12.007; Gaeta Gazzola, M., Carmichael,
I.D., Christian, N.J., Zheng, X., Madden, L.M., &
Barry, D. T. (2023). ‘‘A national study of
homelessness, social determinants of health, and
treatment engagement among outpatient medication
for opioid use disorder-seeking individuals in the
United States.’’ Substance Abuse, 44(1–2), 62–72.
https://doi.org/10.1177/0889707723116729.
406 SAMHSA. (2012). Medication-assisted
treatment for opioid addiction in opioid treatment
programs. https://www.ncbi.nlm.nih.gov/books/
NBK64164/pdf/Bookshelf_NBK64164.pdf.
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periodic assessments described by
HCPCS code G2077.
When OTPs bill the intake add-on
code (G2076), we are not proposing to
require that OTPs performed SDOH risk
assessments in a specific manner, but
rather that OTPs continued to perform
initial assessment services consistent
with SAMHSA certification
requirements at § 8.12(f)(4)(i) that
already largely reflect these type of
SDOH risk assessment activities; and,
that OTPs abided by other applicable
requirements under the Medicare OTP
benefit at § 410.67, including those
listed in the definition of intake
activities at paragraph (vi) within the
definition of ‘‘OUD treatment service’’ at
§ 410.67(b). This also means that for the
purposes of Medicare payment, if SDOH
risk assessments are furnished, they
must be related to the diagnosis or
treatment of OUD, and any HRSNs
identified through SDOH risk
assessments performed should be
documented in the patient’s medical
record to indicate how assessing and
addressing the HRSN relates to the
treatment and diagnosis of an OUD. We
reiterate that our proposal to incorporate
the value of HCPCS code G0136 into the
OTP intake add-on code (G2076) is
meant to serve as a reasonable proxy to
reflect the value and resources of the
type of initial assessment service
activities that OTPs are required to
provide under SAMHSA requirements,
which now include more specific
updates to a patient’s care plan with
considerations of a patient’s goals
related to harm reduction interventions,
needs for recovery support services, and
other HRSNs. However, if OTPs utilize
SDOH risk assessments during intake
activities, CMS is not proposing to
require OTPs to utilize a specific type of
SDOH risk assessment tool, consistent
with similar existing requirements
under the PFS for these services. If
OTPs do furnish these assessment
services, CMS encourages OTPs to adopt
evidence-based, validated tools that are
already available (such as the CMS
Accountable Health Communities tool,
the Protocol for Responding to and
Assessing Patients Assets, Risks and
Experiences (PRAPARE), and
instruments identified for Medicare
Advantage Special Needs Population
Health Risk Assessment); 407 that
include the domains of food insecurity,
housing insecurity, transportation
needs, and utility difficulties, and that
can be furnished in a manner
appropriate for the patient’s
407 https://innovation.cms.gov/files/worksheets/
ahcm-screeningtool.pdf.; https://www.nachc.org/
research-and-data/prapare/; CMS–10825.
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educational, developmental, and health
literacy level, and that are culturally
and linguistically appropriate. We
understand that there is not a national
consensus around one specific tool, and
OTPs should choose the tool that fits
their needs and allows them to
appropriately detect unmet HRSNs, as
well as other needs for harm reduction
interventions and recovery support
services that are integral to the
treatment of an OUD.
Lastly, in light of these proposed
changes, we are proposing to revise the
current descriptor for the intake add-on
code for consistency with revisions to
§ 8.12(f)(4)(i) and to reflect furnishing an
SDOH risk assessment: G2076 (Intake
activities, including initial medical
examination that is a complete, fully
documented physical evaluation and
initial assessment conducted by a
program physician or a primary care
physician, or an authorized healthcare
professional under the supervision of a
program physician or qualified
personnel that includes preparation of a
care plan, which may be informed by
administration of a standardized,
evidence-based Social Determinants of
Health Risk Assessment to identify
unmet health-related social needs, and
that includes the patient’s goals and
mutually agreed-upon actions for the
patient to meet those goals, including
harm reduction interventions; the
patient’s needs and goals in the areas of
education, vocational training, and
employment; and the medical and
psychiatric, psychosocial, economic,
legal, housing, and other recovery
support services that a patient needs
and wishes to pursue, conducted by
qualified personnel (provision of the
services by a Medicare-enrolled Opioid
Treatment Program); List separately in
addition to code for primary procedure).
We welcome public comments related
to this proposal.
b. Request for Information on Payment
for Coordinated Care and Referrals to
Community-Based Organizations That
Address Unmet Health-Related Social
Needs, Provide Harm Reduction
Services, and/or Provide Recovery
Support Services
In the discussion above, we noted that
SAMHSA’s recent reforms to 42 CFR
part 8 finalized new definitions for
harm reduction and recovery support
services, which are included as
components of the type of services that
OTPs may provide. Some examples of
harm reduction strategies include
overdose education, distribution of
opioid overdose reversal medications,
and linkage to other public health
services. Recovery support services can
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include, but are not limited to,
community-based recovery housing,
social support, and linkage to and
coordination among allied service
providers and a full range of human
services that facilitate recovery and
wellness. Under the Medicare OTP
benefit, we have already established
payment for some of these services,
including take-home supplies of opioid
antagonist medications for emergency
treatment of known or suspected opioid
overdose (for example, naloxone),
overdose education furnished in
conjunction with opioid antagonist
medications, and social support via
group therapy. However, we do not
currently have specific coding for
activities that OTPs may conduct to
coordinate care and make referrals or
‘‘link’’ to community-based
organizations (CBOs) that help facilitate
a patient’s needs and goals related to
harm reduction and recovery support
services, as well as to address unmet
HRSNs. We understand that a referral is
an important aspect of following up on
unmet HRSNs identified during an
initial assessment service and/or SDOH
risk assessment so that a patient can be
connected to resources or services that
may help address their unmet HRSN
that interferes with treatment of their
OUD. Additionally, we have received
previous comments that OTPs often
have collaborative agreements with
providers outside of the OTP. For these
reasons, we are seeking comment to
understand how OTPs are currently
coordinating care and making referrals
to CBOs that address unmet HRSNs,
provide harm reduction services, and/or
provide recovery support services.
Some evidence has indicated that
providers who coordinate care with
CBOs to address HRSNs (for example,
housing, transportation, care
management, etc.) can positively
influence health outcomes,408 and that
SUD treatment facilities establishing
relationships with community-based
peer support services, educational and
employment agencies, housing agencies,
and other organizations have been able
to better support a patient’s engagement
in SUD treatment.409 Additionally, harm
408 McCarthy, D., Lewis, C., Horstman, C., Bryan,
A., & Shah, T. (2022). ‘‘Guide to Evidence for
Health-Related Social Needs Interventions: 2022
Update’’ [ROI Calculator for Partnerships to
Address the Social Determinants of Health]. The
Commonwealth Fund. https://
www.commonwealthfund.org/sites/default/files/
2022-09/ROI_calculator_evidence_review_2022_
update_Sept_2022.pdf.
409 O’Brien, P., Crable, E., Fullerton, C., &
Hughey, L. (2019). ‘‘Best Practices and Barriers to
Engaging People with Substance Use Disorders in
Treatment.’’ ASPE. https://aspe.hhs.gov/sites/
default/files/private/pdf/260791/BestSUD.pdf.
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reduction organizations, including
syringe service programs, function as
important facilitators of entry to
treatment, as individuals who partake in
these programs are five times more
likely to enter treatment, more likely to
remain engaged in treatment, and more
likely to reduce their injection drug
use.410 Additionally, recovery support
services, such as those linking
individuals in SUD treatment who are
also experiencing homelessness with
supportive or transitional housing, have
resulted in improved uptake of
behavioral health visits; 411 and,
recovery support services facilitated by
peers who have recovered from a SUD
have been shown to reduce relapse
rates, improve treatment retention,
enhance the provider and patient
relationship, and boost overall treatment
experience.412 Therefore, there is
evidence to suggest that linkage to these
types of community-based resources
may contribute to improved outcomes
related to OUD treatment; however, we
seek comment on additional evidence
that demonstrates how this type of
services would directly help OTPs
address the diagnosis or treatment of an
OUD. CMS would also be interested in
additional evidence describing how
these community-based resources and
coordination of these services with
MOUD provided by OTPs would impact
access to treatment for Medicare
beneficiaries who may face barriers in
accessing treatment, such as those who
are residents of rural areas, racial/ethnic
minorities, living with a disability, dualenrollees in Medicare and Medicaid,
and low-income, or other populations
who may face barriers in accessing
treatment. Additionally, we seek to
identify the types of entities, service
providers, and organizations that OTPs
may interact with on a regular basis to
address a patient’s unmet HRSNs and
needs or goals related to harm reduction
410 Hagan, H., McGough, J.P., Thiede, H.,
Hopkins, S., Duchin, J., & Alexander, E.R. (2000).
‘‘Reduced injection frequency and increased entry
and retention in drug treatment associated with
needle-exchange participation in Seattle drug
injectors.’’ Journal of Substance Abuse Treatment,
19(3), 247–252. https://doi.org/10.1016/s07405472(00)00104-5.
411 Brennan, K., Buggs, K., Zuckerman, P.,
Muyeba, S., Henry, A., Gettens, J., & Kunte, P.
(2020). ‘‘The Preventive Effect of Housing First on
Health Care Utilization and Costs among
Chronically Homeless Individuals.’’ https://
www.bluecrossmafoundation.org/sites/g/files/
csphws2101/files/2020-12/Housing%20First_
summary_Final.pdf.
412 Reif, S., Braude, L., Lyman, D.R., Dougherty,
R.H., Daniels, A.S., Ghose, S.S., Salim, O., &
Delphin-Rittmon, M.E. (2014). ‘‘Peer recovery
support for individuals with substance use
disorders: Assessing the evidence.’’ Psychiatric
Services, 65(7), 853–861. https://doi.org/10.1176/
appi.ps.201400047.
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and recovery support services. For
example, we seek to understand if these
entities would typically include housing
or transportation agencies, local support
groups, syringe service programs, nonprofits that provide financial assistance,
etc. We are also seeking information on
the types of collaborative arrangements
that OTPs typically have with these
CBOs, including how frequently (for
example, weekly, monthly, annually,
etc.) OTPs coordinate care or make
referrals to these CBOs for patients with
an OUD, the types of circumstances that
warrant an OTP interacting with these
CBOs, and the workflows originating
from the initial SDOH assessment to
identify these HRSNs to a beneficiary
successfully receiving referred services.
We are also interested in learning to
what extent some of these programs are
already integrated into OTP settings.
Moreover, we are also interested in
learning when these coordinated
activities and/or referrals occur in the
process of furnishing care to a
beneficiary. For example, a component
of SAMHSA’s new revised standards for
MOUD treatment under counseling and
psychoeducational services at
§ 8.12(f)(5)(iii) suggests that OTPs must
provide directly, or through referral to
adequate and reasonably accessible
community resources, vocational
training, education, and employment
services for patients who request such
services or for whom these needs have
been identified and mutually agreed
upon as beneficial by the patient and
program staff. Thus, we are soliciting
comment on whether these coordination
and referral services typically occur
during SUD counseling session services,
or if they may occur during initial or
periodic assessments, therapy sessions,
or as part of other services. We are also
interested in understanding if, when
billing for intake activities (G2076),
periodic assessments (G2077),
additional therapy/counseling (G2080),
and/or the non-drug component code
(G2074) under the Medicare OTP
benefit, OTPs are already accounting for
these coordinated care and referral
services as part of those codes.
We are also interested in additional
information related to payment for these
types of coordinated care or referral
services. Specifically, we seek comment
on the resource costs that OTPs must
expend to coordinate or make referrals
to community-based services that
address HRSNs, harm reduction, or
recovery support needs. We are also
especially interested in whether there is
existing coding that properly describes
these types of coordinated care or
referral services, or whether there are
elements to these types of services that
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61829
are unique to OTPs and require new
coding. We seek comment on if any of
the following codes below may describe
the type of coordinated care or referral
activities that OTPs may provide, or if
there are other codes that more precisely
match the type of coordinated care or
referral activities at OTPs: community
health integration (G0019& G0022),
principal illness navigation (G0023,
G0024, G0140, G0146), chronic care
management (99437, 99439, 99490,
99491), complex chronic care
management (99487, 99489), principal
care management (99424, 99425, 99426,
99427), or other codes, including any
other relevant codes used by other
payers.
Lastly, we are seeking information on
whether OTPs already receive funding
for these types of coordinated care or
referral services from other public or
private sources, and if additional
payment would be duplicative or
unnecessary. We are interested in
learning, for example, if OTPs already
receive state or Federal grants for these
types of activities (for example, the
SAMHSA Harm Reduction Grant
Program, Rural Communities Opioid
Response Program, State Opioid
Response Grants, Building Communities
of Recovery, Substance Use Prevention,
Treatment, and Recovery Services Block
Grant, etc.).413 Additionally, CMS
would like to understand if OTPs
already receive payment from states
who might already cover these services
under state Medicaid programs,
including through section 1115 waiver
demonstrations and delivery system
reform incentive payments, state plan
amendments, managed care contracts, or
other service benefits and payment
arrangements,414 and if new coding
under the Medicare OTP benefit may
unintentionally supplant coverage for
dually eligible beneficiaries. We
appreciate any feedback submitted by
the public on these questions and issues
to better understand activities that OTPs
conduct to coordinate care and make
referrals to CBOs that address unmet
health-related social needs, provide
413 https://www.samhsa.gov/grants/grantannouncements/sp-22-001; https://grants.hrsa.gov/
2010/Web2External/Interface/FundingCycle/
ExternalView.aspx?fCycleID=af0c3bac-6d99-4314ab7b-c1602e6c471c; https://www.samhsa.gov/
grants/grants-dashboard; https://nashp.org/
funding-options-for-states/.
414 Artiga, S., & Published, E. H. (2018, May 10).
‘‘Beyond health care: The role of social
determinants in promoting health and health
equity.’’ KFF. https://www.kff.org/racial-equityand-health-policy/issue-brief/beyond-health-carethe-role-of-social-determinants-in-promotinghealth-and-health-equity/;https://
www.health.ny.gov/diseases/aids/consumers/
prevention/medicaid_harm_reduction.htm.
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harm reduction services, and/or provide
recovery support services.
4. Establishing Payment for New FDAApproved Opioid Agonist and
Antagonist Medications
Section 1861(jjj)(1)(A) of the Act
establishes Medicare payment for opioid
agonist and antagonist treatment
medications (including oral, injected, or
implanted versions) that are approved
by the Food and Drug Administration
under section 505 of the Federal Food,
Drug, and Cosmetic Act (FFDCA) for use
in the treatment of OUD and as part of
OUD treatment services under the OTP
benefit. Additionally, section 1834(w)(2)
of the Act granted CMS the authority to
establish multiple bundled payments in
stating that the ‘‘Secretary may
implement this subsection through one
or more bundles based on the type of
medication provided (such as
buprenorphine, methadone, naltrexone,
or a new innovative drug), the frequency
of services, the scope of services
furnished, characteristics of the
individuals furnished such services, or
other factors as the Secretary determine
appropriate.’’ In the CY 2020 PFS final
rule, we finalized basing the OTP
bundled payments, in part, on the type
of medication used for treatment that
reflect those drugs currently approved
by the FDA under section 505 of the
FFDCA for use in treatment of OUD.
Accordingly, at § 410.67(d)(1) we
specified that CMS would establish
categories of bundled payments for
OTPs for an episode of care, including
categories for each type of opioid
agonist and antagonist treatment
medication, a category for medications
not otherwise specified, and a category
for episodes of care in which no
medication is provided. At
§ 410.67(d)(2) we finalized that the
bundled payment amounts for an
episode of care would be based on both
a drug and non-drug component, and
we codified the payment methodology
for determining these components. At
§ 410.67(d)(4), we described various
adjustments that could be made to the
bundled payment. Since the
implementation of the Medicare OTP
benefit on January 1, 2020, we have
established bundled payments and/or
add-on codes for the following
medications: methadone (G2067 &
G2078), oral buprenorphine (G2068 &
G2079), injectable buprenorphine
(G2069), buprenorphine implants
(G2070 through G2072), naltrexone
(G2073), nasal naloxone (G2215 &
G1028), injectable naloxone (G2216),
and medication not otherwise specified
(G2075) (for new FDA-approved opioid
agonist or antagonist medications for
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OUD treatment that is not specified in
one of our existing codes). In this CY
2025 PFS proposed rule, we are
proposing new payment for injectable
buprenorphine and nalmefene
hydrochloride products furnished by
OTPs.
a. Coding and Payment for a New
Nalmefene Hydrochloride Product,
Opvee®
In May of 2023, the FDA approved the
first nalmefene hydrochloride
(nalmefene) nasal spray (under the
brand name Opvee®), which is
indicated for the emergency treatment of
known or suspected opioid overdose
induced by natural or synthetic opioids.
This is the first FDA approval of a nasal
spray for nalmefene hydrochloride for
health care and community use, and it
is intended for immediate
administration as emergency therapy in
settings where opioids may be present.
Nalmefene acts as an opioid receptor
antagonist and when administered
quickly, it can reverse the effects of an
opioid overdose including respiratory
depression, sedation, and low blood
pressure.415 Newly approved Opvee®
delivers 2.7 milligrams (mg) of
nalmefene in a single spray into the
nasal cavity. After the first dose is
administered, if the patient does not
respond, or responds and then relapses
into respiratory depression, additional
doses of the Opvee® nasal spray may be
administered with an additional spray
every 2 to 5 minutes until emergency
medical assistance arrives.416 Compared
to naloxone which has a half-life of
approximately 2 hours and also rapidly
reverses the effects of an opioid
overdose, nalmefene has a half-life of 11
hours which means that it remains in
the body much longer than other
overdose reversal drugs.417 The rise of
dangerous synthetic opioids, such as
fentanyl and its analogs sufentanil and
carfentanil, have made it increasingly
difficult for first responders to reverse
the effects of an overdose. These
synthetics have a high potency and
longer half-lives than naloxone (7–8
hours for fentanyl; 6–9 hours for
sufentanil; 5–6 hours for carfentanil;
and 1.3–2.4 hours for naloxone), which
means that very high doses of naloxone
are often required to treat opioid
overdose and prevent recurring
415 https://www.fda.gov/news-events/pressannouncements/fda-approves-prescription-nasalspray-reverse-opioid-overdose.
416 https://www.accessdata.fda.gov/drugsatfda_
docs/label/2023/217470Orig1s000.pdf.
417 Harris, E. (2023). ‘‘FDA approves nalmefene, a
longer-lasting opioid reversal nasal spray.’’ JAMA,
329(23), 2012. https://doi.org/10.1001/
jama.2023.9608.
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overdose symptoms,418 which further
demonstrates the necessity for new
overdose reversal products that can
counter these highly potent opioid
synthetics. In one study, 2.7 mg of
Opvee® reversed respiratory depression
to baseline levels within 5 minutes,
whereas 4 mg of intranasal naloxone did
so within 20 minutes,419 demonstrating
the effectiveness of Opvee® in quickly
reversing symptoms of opioid overdose.
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 (G2215) and injectable
naloxone (G2216). Additionally, we
used our discretionary authority in
section 1861(jjj)(1)(F) of the Act (which
generally authorizes us to include as an
OTP treatment service other items and
services we determine are appropriate)
to extend the definition of OUD
treatment services to include shortacting opioid antagonist medications for
the emergency treatment of known or
suspected opioid overdose, such as
naloxone, and overdose education
furnished in conjunction with opioid
antagonist medication. We also
established an adjustment at
§ 410.67(d)(4)(i)(E) to the weekly
bundled payments when the OTP
furnishes take-home supplies of these
medications. This adjustment includes
both a drug component and a non-drug
component for overdose education. The
payment methodology for the drug
component of the adjustment was
finalized at § 410.67(d)(2)(i) and is
updated annually using the most recent
data available at the time of ratesetting.
The amount of the non-drug component
of the adjustment, which includes
overdose education, is based on the CY
2020 Medicare payment rate for CPT
code 96161 (Administration of caregiver
focused health risk assessment
instrument (e.g., depression inventory)
for the benefit of the patient, with
scoring and documentation, per
standardized instrument). We also
finalized that any payment to an OTP
for naloxone would be duplicative if a
claim for the same medication is
separately paid under Medicare Part B
or Part D for the same beneficiary on the
same date of service, and that we would
418 Krieter, P., Gyaw, S., Crystal, R., & Skolnick,
P. (2019). ‘‘Fighting fire with fire: Development of
intranasal nalmefene to treat synthetic opioid
overdose.’’ The Journal of Pharmacology and
Experimental Therapeutics, 371(2), 409–415.
https://doi.org/10.1124/jpet.118.256115.
419 Ellison, M., Hutton, E., Webster, L., &
Skolnick, P. (2024). ‘‘Reversal of opioid-induced
respiratory depression in healthy volunteers:
Comparison of intranasal nalmefene and intranasal
naloxone.’’ The Journal of Clinical Pharmacology,
jcph.2421. https://doi.org/10.1002/jcph.2421.
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recoup any duplicative payment made
to an OTP for naloxone.
Furthermore, 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 (G0128). We also finalized that
the adjustment includes take-home
supplies of opioid antagonist
medications in the list of items for
which the non-drug component will be
geographically adjusted using the
Geographic Adjustment Factor (GAF)
and the payment amount will be
updated annually by the growth in the
Medicare Economic Index (MEI). Lastly,
we revised our regulations at
§ 410.67(d)(5) to state explicitly that
payments for medications that are
delivered, administered or dispensed to
a beneficiary as part of an adjustment to
the bundled payment are considered a
duplicative payment if a claim for
delivery, administration or dispensing
of the same medication(s) for the same
beneficiary on the same date of service
was also separately paid under
Medicare Part B or Part D. We clarified
that this revision would apply not only
to duplicative payments for take-home
supplies of naloxone, but also to
duplicative payments for additional
take-home supplies of other medications
that are made under § 410.67(d)(4)(i)(D).
In light of a novel nalmefene product,
Opvee®, receiving FDA approval as an
opioid antagonist medication for the
emergency treatment of known or
suspected opioid overdose, we are
proposing to make payment for this new
drug under the Medicare OTP benefit.
Expanding access to overdose reversal
medications, such as nalmefene, is a
critical component to confronting the
opioid crisis. The number of drug
overdose deaths involving prescription
opioids has grown by nearly five-fold in
the past two decades. In 2021, almost
81,000 opioid overdose deaths occurred
in the U.S, and nearly 88 percent of
opioid-involved deaths involved
synthetic opioids like fentanyl and
fentanyl analogs (acetylfentanyl,
furanylfentanyl, and carfentanil). Due to
the high potency of drugs in the nation’s
drug supply, this has often meant that
higher doses, or even multiple doses, of
overdose reversal medications are
needed per overdose event to revive a
patient.420 These increasing rates of
drug overdose deaths has also been seen
among the Medicare-eligible population
with adults aged 65 and over
experiencing the largest percentage
increase (28 percent) in drug overdose
420 https://www.cdc.gov/drugoverdose/deaths/
index.html.
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deaths rates between 2020 and 2021,421
and the rate of drug overdose deaths
involving synthetic opioids among this
age group increased by over 53 percent
in only one year (between 2019 and
2020).422 Over 50,000 Medicare Part D
beneficiaries were estimated to have
experienced an opioid overdose in 2021,
and the number of these beneficiaries
receiving naloxone has grown.423 Not
only has the opioid crisis impacted the
Medicare-eligible population, but health
disparities in drug overdose deaths have
persisted. Non-Hispanic Black men aged
65 and over have experienced drug
overdose death rates that are more than
four times higher than Hispanics and
non-Hispanic whites.424 In addition,
death rates from drug overdoses among
people aged 65 and over have increased
at faster rates for men than women.425
Expanding access to overdose reversal
medications is important, including for
populations at a greater risk for drug
overdose, as overdose reversal
medications have been regarded as an
evidence-based strategy to help
individuals quickly respond to an
overdose to reduce drug overdose
deaths, increase survival rates, and
reduce opioid-related emergency
department visits.426 Lastly, we believe
this proposal to pay for Opvee® under
the OTP benefit would further the
objectives of the HHS Overdose
Prevention Strategy and the National
Drug Control Strategy, which both aim
to widen availability and access to
opioid overdose reversal treatments.427
Section 1861(jjj)(1)(A) of the Act
recognizes opioid agonist and antagonist
treatment medications (including oral,
injected, or implanted versions) that are
approved by the FDA under section 505
of the FFDCA for the use in treatment
of OUD, but nalmefene is not on the list
of drugs for the treatment of OUD.428
When CMS first finalized payment for
nasal and injectable naloxone under the
OTP benefit in the CY 2021 PFS final
rule (85 FR 84682 through 84689 and
85026 through 85027), we used our
discretionary authority under section
1861(jjj)(1)(F) of the Act to finalize and
421 https://www.cdc.gov/nchs/products/
databriefs/db457.htm.
422 https://blogs.cdc.gov/nchs/2023/06/30/7408/.
423 https://oig.hhs.gov/oei/reports/OEI-02-2200390.pdf.
424 https://www.cdc.gov/nchs/products/
databriefs/db455.htm.
425 https://blogs.cdc.gov/nchs/2022/11/30/7193/.
426 https://www.cdc.gov/drugoverdose/pdf/pubs/
2018-evidence-based-strategies.pdf.
427 https://www.hhs.gov/overdose-prevention/;
https://www.whitehouse.gov/wp-content/uploads/
2022/04/National-Drug-Control-2022Strategy.pdf.
428 https://www.fda.gov/drugs/information-drugclass/information-about-medication-assistedtreatment-mat.
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61831
extend the definition of OUD treatment
services to include short acting opioid
antagonist medications (e.g naloxone)
that are approved by the FDA under
section 505 of the FFDCA for the
emergency treatment of known or
suspected opioid overdose. Since
nalmefene was approved by the FDA
under section 505(b)(2) authority,429
and is an opioid antagonist and on the
list of overdose reversal drugs approved
by the FDA,430 we believe nalmefene is
consistent with our definition of OUD
treatment service at § 410.67(d), which
describes opioid antagonist medications
that are approved by the FDA under
section 505 of the FFDCA for the
emergency treatment of known or
suspected opioid overdose at paragraph
(viii). Therefore, we believe it is
appropriate to propose new payment for
nalmefene as it would align with
existing authority under § 410.67(b) that
recognizes opioid antagonist
medications which treat known or
suspected opioid overdose as an OUD
treatment service.
We are proposing to create a new
adjustment to the bundled payment for
nalmefene hydrochloride (Opvee®)
described by GOTP1 [Take-home supply
of nasal nalmefene hydrochloride; one
carton of two, 2.7 mg per 0.1 mL nasal
sprays (provision of the services by a
Medicare-enrolled Opioid Treatment
Program); (List separately in addition to
each primary code)]. We would price
this new add-on code based on the
established methodology under the OTP
benefit for determining the adjustment
for take-home supplies of opioid
antagonist medications at
§ 410.67(d)(4)(i)(E). This adjustment
would include both a drug component
and a non-drug component. The amount
of the drug component would be
determined using the methodology for
pricing the drug component of an
episode of care at § 410.67(d)(2)(i),
which tends to use ASP data when
available (with certain exceptions).
Accordingly, consistent with the
approach used to price the drug
component for nasal naloxone (HCPCS
code G2215 & G1028), we would apply
the average sales price (ASP) payment
methodology set forth in section 1847A
of the Act to determine the payment for
the new naloxone hydrochloride nasal
spray product, except that payment
amounts would not include any add-on
percentages if either ASP or wholesale
acquisition cost (WAC) is used. As
stated in the CY 2021 PFS final rule (85
429 https://www.fda.gov/media/171605/download.
430 https://www.fda.gov/drugs/postmarket-drugsafety-information-patients-and-providers/
information-about-naloxone-and-nalmefene.
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FR 84685), we continue to believe that
using ASP provides a transparent and
public benchmark for manufacturers’
actual pricing as it reflects the
manufacturers’ actual sales prices to all
purchasers (with limited exceptions as
noted in section 1847A(c)(2) of the Act)
and is the only pricing methodology
that includes off-invoice rebates and
discounts as described in section
1847A(c)(3) of the Act. Therefore, we
believe ASP to be the most market-based
approach to set drug prices, including
for the new nalmefene nasal product. As
we stated in the CY 2020 PFS final rule,
we also continue to believe that limiting
the payment amount to 100-percent of
the volume-weighted ASP for a HCPCS
code will incentivize the use of the most
clinically appropriate drug for a given
patient (84 FR 62651 through 62656).
We understand that many OTPs
purchase medications directly from
manufacturers, thereby limiting the
markup from distribution channels.
Furthermore, as stated in the CY 2020
PFS final rule (84 FR 62650), we usually
use the typical maintenance dose to
calculate the drug component for the
OTP benefit. As part of determining a
payment rate for the proposed bundles
for OUD treatment services, a dosage of
the applicable medication is often
selected to calculate the costs of the
drug component of the bundle.
According to the product information
for Opvee®, each unit-dose nasal spray
device delivers 2.7 mg of nalmefene in
0.1 mL.431 Each unit-dose device
contains a single dose of nalmefene, so
it delivers its entire contents
automatically and cannot be reused.
Each carton contains two unit-dose
nasal spray devices to allow for an
additional repeat dose if needed. Thus,
we are proposing to price the drug
component of the code for nalmefene
based on an assumption of a typical
dosage for this new product to be a
carton containing two 2.7 mg nasal
sprays. We would, therefore, multiply
the payment amount of 100-percent of
the volume-weighted ASP reported for
2.7 mg of nalmefene by two in order to
reflect a carton of two nasal spray
devices. We seek comment on whether
this amount (a carton of two, 2.7 mg
nasal sprays) reflects the typical
maintenance dosage for this drug when
administered. The payment limit for
Opvee® in the April 2024 ASP pricing
file is $92.033, which reflects a carton
of two, 2.7mg nasal sprays and would be
used to price the drug component of
GOTP1.
431 https://www.accessdata.fda.gov/drugsatfda_
docs/label/2023/217470Orig1s000.pdf.
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Additionally, consistent with the
methodology established in
§ 410.67(d)(4)(i)(E), we propose to
include a non-drug component for
GOTP1 that would include payment for
overdose education. Overdose education
is an important component of overdose
prevention and includes educating
patients and caregivers on how to
recognize respiratory depression, the
signs and symptoms of a possible opioid
overdose, how to administer overdose
reversal medications, and the
importance of calling 911 or getting
emergency medical help right away,
even after the overdose reversal
medication is administered.432
Additionally, overdose education paired
with distribution of overdose reversal
medications has been found to be
effective in improving knowledge about
opioid overdose, improving attitudes
toward using overdose reversal
medications, training individuals to
safely and effectively manage overdoses,
and reducing opioid-related
mortality.433 For these reasons, we are
proposing to include a non-drug
component to GOTP1 based on the CY
2020 Medicare payment rate for CPT
code 96161 (Administration of
caregiver-focused health risk assessment
instrument (e.g., depression inventory)
for the benefit of the patient, with
scoring and documentation, per
standardized instrument) and updated
to reflect the MEI updates that have
been applied since that time. This is
consistent with the payment
methodology for naloxone and the
language in § 410.67(d)(4)(i)(E). In
addition, the language at
§ 410.67(d)(4)(ii) currently states that
the non-drug component of the
adjustments for take-home supplies of
opioid antagonist medications will be
geographically adjusted using the
geographic adjustment factor described
in § 414.26. Separately,
§ 410.67(d)(4)(iii) states that the nondrug component of the adjustments for
take-home supplies of opioid antagonist
medications will be updated annually
using the Medicare Economic Index
described in § 405.504. Since we are
proposing to establish payment for
Opvee® through an adjustment to the
bundled payment, and since Opvee® is
also considered an opioid antagonist
432 https://www.fda.gov/media/140360/
download#.
433 Razaghizad, A., Windle, S. B., Filion, K. B.,
Gore, G., Kudrina, I., Paraskevopoulos, E.,
Kimmelman, J., Martel, M. O., & Eisenberg, M. J.
(2021). ‘‘The effect of overdose education and
naloxone distribution: An umbrella review of
systematic reviews.’’ American Journal of Public
Health, 111(8), e1–e12. https://doi.org/10.2105/
AJPH.2021.306306.
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medication, we are also proposing to
update the non-drug component for the
adjustment of GOTP1 annually based on
the GAF and MEI.
Furthermore, consistent with our
established criteria for opioid antagonist
medications at § 410.67(d)(4)(i)(E), we
are also proposing to limit payment for
Opvee® to one add-on code (GOTP1)
every 30 days. However, we believe that
access to Opvee® should not be limited
when it is medically reasonable and
necessary as part of the treatment for
OUD and known or suspected opioid
overdose. Therefore, similar to
flexibilities established for frequency
limits for naloxone, we are proposing to
allow exceptions to this limit in the case
where the beneficiary overdoses and
uses the initial supply of nalmefene
dispensed by the OTP to the extent that
it is medically reasonable and necessary
to furnish additional nalmefene. We
note that section 1862(a)(1)(A) of the
Act requires that for payment to be
made for most Part A and Part B
services furnished to Medicare
beneficiaries, those services must be
reasonable and necessary for the
diagnosis or treatment of illness or
injury or to improve the malfunctioning
of a malformed body member. If an
additional supply of Opvee® is needed
within 30 days of the original supply
being provided, we propose that OTPs
must document in the medical record
the reason for the exception. Moreover,
section 1834(w)(1) of the Act, added by
section 2005(c) of the SUPPORT Act,
requires the Secretary to ensure, as
determined appropriate by the
Secretary, that no duplicative payments
are made under Medicare Part B or Part
D for items and services furnished by an
OTP. Similar to naloxone, we recognize
that nalmefene may also be
appropriately available to beneficiaries
through other Medicare benefits,
including under Medicare Part D. At
§ 410.67(d)(5), we define duplicative
payment to involve circumstances when
medications are delivered, administered
or dispensed to a beneficiary are paid as
part of the OTP bundled payment, and
where the delivery, administration or
dispensing of the same medication (that
is, same drug, dosage and formulation)
is also separately paid under Medicare
Part B or Part D for the same beneficiary
on the same date of service. Consistent
with § 410.67(d)(5), we propose that
CMS recoup duplicative payments made
to an OTP for Opvee®. CMS expects that
if the OTP provides reasonable and
necessary medications for an OUD as
part of an episode of care, the OTP will
take measures to ensure that there is no
claim for payment for these drugs other
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than as part of the OTP bundled
payments. Thus, Opvee® billed by an
OTP as an add-on to the bundled
payment should not be reported to or
paid under a Medicare Part D plan.
We welcome comments related to this
proposal to establish an adjustment to
the bundled payment for Opvee®
[(GOTP1: Take-home supply of nasal
nalmefene hydrochloride; one carton of
two, 2.7 mg per 0.1 mL nasal sprays
(provision of the services by a Medicareenrolled Opioid Treatment Program);
(List separately in addition to each
primary code)], as well as comments
related to applicable requirements and
criteria for billing this code.
lotter on DSK11XQN23PROD with PROPOSALS2
b. Coding and Payment for New
Injectable Buprenorphine Product
Brixadi®
Another medication for the treatment
of OUD for which the Secretary may
establish payment is buprenorphine,
which is a partial opioid agonist that is
FDA approved to treat OUD.
Buprenorphine is a schedule III
substance, meaning it has low to
moderate potential for physical
dependence.434 When taken as
prescribed, it can diminish the effects of
opioid withdrawal symptoms and
cravings.435 In the CY 2020 PFS final
rule (84 FR 62630 through 62677 and 84
FR 62919 through 62926), we
established a weekly bundled payment
under the Medicare OTP benefit for
injectable buprenorphine (HCPCS
G2069: Medication assisted treatment,
buprenorphine (injectable); weekly
bundle including dispensing and/or
administration, substance use
counseling, individual and group
therapy, and toxicology testing if
performed (provision of the services by
a Medicare-enrolled Opioid Treatment
Program)). CMS also established
payment for other formulations of
buprenorphine, including weekly
bundles for oral buprenorphine (G0268),
buprenorphine implants (G2070 through
G2072), and take-home supplies of oral
buprenorphine (G2079), as well as other
medications like methadone and
naltrexone. At § 410.67(d)(2), we
codified that the bundled payment for
episodes of care in which a medication
is provided will consist of a payment for
a drug component, reflecting payment
for the applicable FDA-approved opioid
434 https://www.dea.gov/drug-information/drugscheduling.
435 National Academies of Sciences, Engineering,
and Medicine. (2019). ‘‘The effectiveness of
medication-based treatment for opioid use
disorder.’’ In M. Mancher & A. I. Leshner (Eds.),
Medications for Opioid Use Disorder Save Lives.
National Academies Press (U.S.). https://
www.ncbi.nlm.nih.gov/books/NBK541393/.
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agonist or antagonist medication in the
patient’s treatment plan, and a non-drug
component, reflecting payment for all
other OUD treatment services reflected
in the patient’s treatment plan
(including dispensing/administration of
the medication, if applicable). The
payments for the drug component and
non-drug component are added together
to create the bundled payment amount.
In the CY 2020 PFS final rule, CMS
finalized a payment methodology for the
drug component related to implantable
and injectable medications at 42 CFR
410.67(d)(2)(i)(A), which applied to the
bundled payment for injectable
buprenorphine (G2069).
For implantable and injectable
medications paid under the OTP
benefit, the payment is determined
using the methodology set forth in
section 1847A of the Act, except that the
payment amount must be 100 percent of
the ASP, if ASP is used; and the
payment must be 100 percent of the
WAC, if WAC is used. We also stated in
the CY 2020 PFS final rule that the
typical maintenance dose to calculate
the drug component for payment under
the OTP benefit, as dosing for some, but
not all, of the drugs varies considerably
(84 FR 62650). As part of determining a
payment rate for the proposed bundles
for OUD treatment services, a dosage of
the applicable medication must be
selected to calculate the costs of the
drug component of the bundle. In the
CY 2020 PFS final rule, we finalized
using a 100 mg monthly dose for the
extended-release buprenorphine
injection to use as the typical or average
maintenance dose to calculate the drug
component of the bundle for injectable
buprenorphine (G2069). At the time of
ratesetting for the CY 2020 PFS rule, the
only injectable extended-release
buprenorphine drug available and
approved by the FDA under section 505
of the FFDCA for the treatment of OUD
was Sublocade®; 436 and, the drug
component for the bundle was based on
a crosswalk to its respective HCPCS
codes Q9991 (Buprenorphine XR 100
mg or less) and Q9992 (Buprenorphine
XR over 100 mg) using the methodology
set forth in section 1874A of the Act,
except that the payment amount was
100-percent of the ASP. In the CY 2020
PFS final rule, we noted that the HCPCS
codes for extended-release
buprenorphine injection had the same
payment rate, thus we did not believe it
was necessary to establish a second
typical maintenance dose to calculate
the payment rate for the drug. For the
non-drug component of the weekly
436 https://www.accessdata.fda.gov/drugsatfda_
docs/label/2018/209819s001lbl.pdf.
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61833
bundle for injectable buprenorphine
(G2069), we finalized that in addition to
services for substance use counseling,
individual and group therapy, and
toxicology testing, we would include
the Medicare non-facility rate for
administration of an injection in our
determination of the payment rate based
on CPT code 96372 (Therapeutic,
prophylactic, or diagnostic injection
(specify substance or drug);
subcutaneous or intramuscular).
In May of 2023, the FDA approved a
new drug application (NDA) under
section 505(b)(2) of the FFDCA for
another extended-release buprenorphine
injection (Brixadi®) for subcutaneous
use to treat moderate to severe OUD.437
Clinical data suggest that Brixadi® likely
contributes to high rates of treatment
retention, reductions in opioid
withdrawal and cravings, and fewer
levels of illicit opioid use.438 Brixadi® is
available in two formulations, a weekly
injection (containing 50 mg of
buprenorphine per mL) that can be used
in patients who have started treatment
with a single dose of a transmucosal
buprenorphine product or who are
already being treated with
buprenorphine-containing products,
and a monthly injection (containing 356
mg of buprenorphine per mL) for
patients already being treated with
buprenorphine. The weekly and
monthly formulations of the drug are
available at varying doses, including
lower doses that may be appropriate for
those who do not tolerate higher doses
of extended-release buprenorphine that
are currently available.439 The weekly
doses are 8 mg, 16 mg, 24 mg, and 32
mg, and should be administered in 7day intervals; and the monthly doses are
64 mg, 96 mg, and 128 mg, and should
be administered in 28-day intervals.440
Buprenorphine is associated with
decreasing the risk for overdose, opioidrelated mortality, and all-cause
mortality.441 Data also shows that
437 https://www.fda.gov/news-events/pressannouncements/fda-approves-new-buprenorphinetreatment-option-opioid-use-disorder.
438 Frost, M., Bailey, G. L., Lintzeris, N., Strang,
J., Dunlop, A., Nunes, E. V., Jansen, J. B., Frey, L.
C., Weber, B., Haber, P., Oosman, S., Kim, S., &
Tiberg, F. (2019). ‘‘Long-term safety of a weekly and
monthly subcutaneous buprenorphine depot in the
treatment of adult out-patients with opioid use
disorder.’’ Addiction, 114(8), 1416–1426. https://
doi.org/10.1111/add.14636.
439 https://www.fda.gov/news-events/pressannouncements/fda-approves-new-buprenorphinetreatment-option-opioid-use-disorder.
440 https://www.accessdata.fda.gov/drugsatfda_
docs/label/2023/210136Orig1s000lbl.pdf.
441 Larochelle, M. R., Bernson, D., Land, T.,
Stopka, T. J., Wang, N., Xuan, Z., Bagley, S. M.,
Liebschutz, J. M., & Walley, A. Y. (2018).
‘‘Medication for opioid use disorder after nonfatal
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buprenorphine helps retain individuals
in treatment, lowers illicit opioid use,
and reduces drug-related behaviors that
increase the risk for HIV
transmission.442 In particular, longacting (for example, extended-release)
injectable forms of buprenorphine have
been shown to promote adherence to
treatment while reducing the need for
daily dosing, and to enhance patientreported outcomes through
improvements in quality of life,
accessibility, social relationships,
participation in employment, more
flexible personal and professional
schedules, and other treatment
satisfaction measures.443 Finally, a large
percentage of Medicare beneficiaries
with an OUD continue to face
challenges in accessing medication,
especially enrollees who are older,
opioid overdose and association with mortality: A
cohort study.’’ Annals of Internal Medicine, 169(3),
137. https://doi.org/10.7326/M17-3107; Wakeman,
S. E., Larochelle, M. R., Ameli, O., Chaisson, C. E.,
McPheeters, J. T., Crown, W. H., Azocar, F., &
Sanghavi, D. M. (2020). ‘‘Comparative effectiveness
of different treatment pathways for opioid use
disorder.’’ JAMA Network Open, 3(2), e1920622.
https://doi.org/10.1001/
jamanetworkopen.2019.20622.
442 Shulman, M., Wai, J. M., & Nunes, E. V.
(2019). Buprenorphine treatment for opioid use
disorder: An overview. CNS Drugs, 33(6), 567–580.
https://doi.org/10.1007/s40263-019-00637-z;
Thomas, C. P., Fullerton, C. A., Kim, M., Montejano,
L., Lyman, D. R., Dougherty, R. H., Daniels, A. S.,
Ghose, S. S., & Delphin-Rittmon, M. E. (2014).
Medication-assisted treatment with buprenorphine:
Assessing the evidence. Psychiatric Services
(Washington, DC), 65(2), 158–170. https://doi.org/
10.1176/appi.ps.201300256; Gowing, L., Farrell, M.
F., Bornemann, R., Sullivan, L. E., & Ali, R. (2011).
Oral substitution treatment of injecting opioid users
for prevention of HIV infection. The Cochrane
Database of Systematic Reviews, 8, CD004145.
https://doi.org/10.1002/14651858.CD004145.pub4.
443 Maremmani, I., Dematteis, M., Gorzelanczyk,
E. J., Mugelli, A., Walcher, S., & Torrens, M. (2023).
Long-acting buprenorphine formulations as a new
strategy for the treatment of opioid use disorder.
Journal of Clinical Medicine, 12(17), 5575. https://
doi.org/10.3390/jcm12175575; Farrell, M.,
Shahbazi, J., Byrne, M., Grebely, J., Lintzeris, N.,
Chambers, M., Larance, B., Ali, R., Nielsen, S.,
Dunlop, A., Dore, G. J., McDonough, M.,
Montebello, M., Nicholas, T., Weiss, R., Rodgers, C.,
Cook, J., & Degenhardt, L. (2022). Outcomes of a
single-arm implementation trial of extended-release
subcutaneous buprenorphine depot injections in
people with opioid dependence. International
Journal of Drug Policy, 100, 103492. https://doi.org/
10.1016/j.drugpo.2021.103492; Lintzeris, N.,
Dunlop, A. J., Haber, P. S., Lubman, D. I., Graham,
R., Hutchinson, S., Arunogiri, S., Hayes, V.,
Hjelmström, P., Svedberg, A., Peterson, S., & Tiberg,
F. (2021). Patient-reported outcomes of treatment of
opioid dependence with weekly and monthly
subcutaneous depot vs daily sublingual
buprenorphine: A randomized clinical trial. JAMA
Network Open, 4(5), e219041. https://doi.org/
10.1001/jamanetworkopen.2021.9041; Martin, E.,
Maher, H., McKeon, G., Patterson, S., Blake, J., &
Chen, K. Y. (2022). Long-acting injectable
buprenorphine for opioid use disorder: A
systematic review of impact of use on social
determinants of health. Journal of Substance Abuse
Treatment, 139, 108776. https://doi.org/10.1016/
j.jsat.2022.108776.
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female, and who identify as racial/
ethnic minorities.444 The most common
reasons for not receiving SUD treatment
include financial barriers in
affordability and coverage.445
Establishing coverage and payment for a
new medication to treat OUD may
provide more MOUD treatment options,
reduce financial barriers to accessing
medication, and aid health equity efforts
among Medicare beneficiaries.
Accordingly, for these reasons and
because sections 1861(s)(2),
1861(jjj)(1)(A), and 1833(a)(1) of the Act
provide that the Secretary is to provide
coverage and payment for OUD
treatment services including opioid
agonist and antagonist medications that
are FDA approved for use in the
treatment of OUD, we are proposing to
establish payment for the weekly and
monthly formulations for this new FDAapproved injectable buprenorphine
product, Brixadi®, which we believe
would further efforts to address the
opioid crisis and expand access to
evidence-based treatment for OUD.
We are proposing to establish two
different payments, one for each of the
weekly and monthly injectable
formulations of Brixadi®. To establish
payment for the weekly and monthly
formulations of Brixadi®, we are
proposing to use the existing payment
methodology for implantable and
injectable medications codified at
§ 410.67(d)(2)(i)(A). This regulation
specifies that payment is determined
using the methodology set forth in
section 1847A of the Act, except that the
payment amount must be 100 percent of
the ASP, if ASP is used; and the
payment must be 100 percent of the
WAC, if WAC is used.
Payment limits 446 for most drugs and
biologicals 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 ASP plus a statutorily
mandated 6 percent add-on. Most drugs
payable under Part B are paid under the
‘‘incident to’’ benefit under section
444 https://oig.hhs.gov/oei/reports/OEI-02-2300250.pdf.
445 Parish, W. J., Mark, T. L., Weber, E. M., &
Steinberg, D.G. (2022). Substance use disorders
among Medicare beneficiaries: Prevalence, mental
and physical comorbidities, and treatment barriers.
American Journal of Preventive Medicine, 63(2),
225–232. https://doi.org/10.1016/
j.amepre.2022.01.021.
446 In general, CMS establishes a single, national
payment limit to Medicare Administrative
Contractors (MACs) for payment of some Part Bcovered drugs and biologicals whose payment is
determined based on the methodology described in
section 1847A of the Act. CMS provides an ASP
pricing file to MACs, which is updated quarterly.
https://www.cms.gov/medicare/payment/part-bdrugs/asp-pricing-files.
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1861(s)(2) of the Act, which includes
drugs and biologicals not usually selfadministered by the patient. The ASP
payment limit determined under section
1847A of the Act reflects a volumeweighted ASP for all national drug
codes (NDCs) that are assigned to a
HCPCS code. The ASP is calculated
quarterly using manufacturer-submitted
data on sales to all purchasers (with
limited exceptions as articulated in
section 1847A(c)(2) of the Act, such as
for sales at nominal charge and sales
exempt from best price) with
manufacturers’ rebates, discounts, and
price concessions reflected in the
manufacturer’s determination of ASP.
Paragraphs (4)(A) and (6) of sections
1847A(b) of the Act require that the
Medicare Part B payment limit for a
single-source drug or biological be
determined using all of the NDCs
assigned to it. Section 1847A(b)(5) of the
Act further states that the payment limit
shall be determined without regard to
any special packaging, labeling, or
identifiers on the dosage form or
product or package. In 2007, CMS
issued a program instruction,447 as
permitted under section 1847A(c)(5)(C)
of the Act, stating that the payment limit
for a single source drug or biological
will be based on the pricing information
for products produced or distributed
under the applicable FDA approval
(such as a New Drug Application (NDA)
or Biologics License Application (BLA)).
Therefore, all versions of a single source
drug or biological product (or NDCs)
marketed under the same FDA approval
number (for example, NDA or BLA,
including supplements) are considered
the same drug or biological for purposes
of payments made under section 1847A
of the Act and are crosswalked to the
same billing and payment code.
We continue to believe that use of
ASP provides a transparent and public
benchmark for manufacturers’ pricing as
it reflects the manufacturers’ actual
sales prices to all purchasers (with
limited exceptions) and is the only
pricing methodology that includes off
invoice rebates and discounts as
described in section 1847A(c)(3) of the
Act. Additionally, since many other
injectable drugs are paid for under
Medicare part B through the ASP
payment methodology in 1847A, we
presume that this methodology is
appropriate for pricing Brixadi®. We
also propose to limit the payment
amount to 100-percent of ASP without
a 6-percent add-on percentage since, as
we have previously noted, it is our
447 https://www.cms.gov/Medicare/Coding/
MedHCPCSGenInfo/Downloads/051807_coding_
annoucement.pdf.
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understanding that many OTPs
purchase directly from drug
manufacturers, thereby limiting the
markup from distribution channels.
As we stated in our discussion above,
we use the typical or average
maintenance dose of a drug to
determine the drug costs for each of the
bundles. In the CY 2020 PFS final rule,
we noted that there are often variations
in the dosage and frequency of
administration of medications, but that
‘‘payment based on the typical dose
means that, across the Medicare
beneficiaries served by the OTP, the
payment amount should be reasonable
and represent the average costs incurred
in furnishing the drug component of the
OUD treatment services.’’ (84 FR 62650).
Therefore, in the CY 2020 PFS final
rule, we finalized using the typical
maintenance dose to establish the drug
costs for each of the bundles as our
approach to addressing variable dosing
of medications. (84 FR 62650).
In the CY 2020 PFS final rule, we
finalized a 100 mg monthly dose for the
extended-release buprenorphine
injection as the typical maintenance
dose, which we used to calculate the
drug component of the weekly bundle
for injectable buprenorphine (G2069).
At the time, we did not establish a
second typical maintenance dose
because both HCPCS codes for the
extended release buprenorphine
injection, that is, Sublocade® [Q9991
(Buprenorphine XR 100 mg or less) and
Q9992 (Buprenorphine XR over 100
mg)] had the same payment limit
because, as explained above in this
section, all NDCs marketed under the
same FDA approval number are
considered the same drug or biological
for purposes of payments made under
section 1847A of the Act and are
crosswalked to the same billing and
payment code. The weekly and monthly
formulations of Brixadi® are described
by HCPCS codes J0577 (Injection,
buprenorphine extended release
(brixadi), less than or equal to 7 days of
therapy) and J0578 (Injection,
buprenorphine extended release
(brixadi), greater than 7 days and up to
28 days of therapy). In the same manner
as Sublocade®, and as explained in the
coding announcement for HCPCS codes
J0577 and J0578,448 because all versions
of a single source drug or biological
product (or NDCs) marketed under the
same FDA approval number are
considered the same drug or biological
for purposes of payments made under
section 1847A of the Act, the payment
448 https://www.cms.gov/files/document/2023hcpcs-application-summary-quarter-4-2023-drugsand-biologicals-updated-03/04/2024.pdf.
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limits for both J0577 and J0578 are
calculated using all the NDCs marketed
under the applicable FDA approval.
However, since the dose descriptions for
these codes are based on days of therapy
(and not a measurement of the amount
of drug, like per 1 mg, as is the case with
Sublocade®), the payment limits for the
two codes are different; in the April
2024 ASP pricing file, the payment limit
for J0577 is $404.086 and the payment
limit for J0578 is $1,616.346. Therefore,
we do not believe it is appropriate to
bundle the weekly and monthly
formulations into a single bundled
payment since, unlike the drug
Sublocade®, the Brixadi® formulations
have different payment limits, and
pricing them under the same bundle
would not adequately represent the
average costs incurred in furnishing
these different formulations in an OTP
setting. Additionally, creating a single
bundled payment rate that does not
reflect the type and cost of the drug
used could result in access issues for
beneficiaries, especially in the event
that the bundled payment amount for
one drug significantly drops and
unintentionally incentivizes treatment
towards a drug with a higher bundled
payment amount.
In establishing the two different
payments for the weekly and monthly
injectable buprenorphine formulations
of Brixadi®, first, we propose to
crosswalk the monthly formulation of
Brixadi® (J0578: Injection,
buprenorphine extended release
(brixadi), greater than 7 days and up to
28 days of therapy) to the drug
component of our existing bundled
payment for injectable buprenorphine
described by HCPCS code G2069
(Medication assisted treatment,
buprenorphine (injectable); weekly
bundle including dispensing and/or
administration, substance use
counseling, individual and group
therapy, and toxicology testing if
performed (provision of the services by
a Medicare-enrolled Opioid Treatment
Program). We propose to average the
payment limits of Sublocade® and
monthly Brixadi® by adding their two
payment limits together and dividing
the sum by two, in order to update the
payment for the drug component of
HCPCS code G2069. We believe
including the average of the payment
limits of Sublocade® and Brixadi® in
the drug component of G2069 rather
than the sum of their respective
individual payment limits is
appropriate because we do not expect
that a beneficiary would receive two
different types of buprenorphine
monthly medication injections
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simultaneously from an OTP (for
example, both Sublocade® and Brixadi®
during the same episode of care and
date of service). We believe that
averaging the price of the two types of
buprenorphine monthly medication
injections would be further be
appropriate because the individual
payment limits for each of the drug
codes (Q9991, Q9992, and J0578) would
both be informed by ASP data and
comparable as they would be priced by
the same ASP payment methodology
(ASP+0). We also note that bundling the
monthly formulation of Brixadi® into
the existing HCPCS code (G2069) for
injectable buprenorphine would be
appropriate and no more
administratively complex for OTPs
since G2069 is already billed on a
monthly basis; Sublocade®, which is
already reflected in the drug component
of G2069 is administered on a monthly
basis to beneficiaries as would be the
monthly formulation of Brixadi®, so
OTPs could continue to bill G2069 once
each month when either monthly
Brixadi® or Sublocade® is administered,
as appropriate.449
Additionally, the average typical dose
of G2069 is 100mg of buprenorphine
administered monthly, as finalized in
the CY 2020 PFS final rule (84 FR
62651). The monthly formulations of
Brixadi® can range from 64 mg, to 96
mg, to 128 mg. The median of these
different doses for the monthly
formulation of Brixadi® (96 mg) would
approximate the average typical dose of
the current injectable buprenorphine
bundle (100 mg). We note that the
different monthly doses of Brixadi® are
assigned to the same HCPCS code J0578
(Injection, buprenorphine extended
release (brixadi), greater than 7 days
and up to 28 days of therapy) and have
the same payment limit regardless of the
monthly dose (64 mg, 96 mg, or 128
mg), so selecting a typical dose of
monthly Brixadi® to potentially adjust
the drug component of G2069 would not
meaningfully change the payment rate.
Therefore, we are not proposing to
establish an average typical dose
different than 100 mg for injectable
buprenorphine administered on a
monthly basis for purposes of
calculating the drug component under
the OTP benefit, though we seek
comment on whether this average
typical dose (100 mg) is close to the
dose for the monthly formulation of
Brixadi® that patients receive on
average.
In all, we believe that bundling the
monthly formulation of Brixadi® into
449 https://www.accessdata.fda.gov/drugsatfda_
docs/label/2018/209819s001lbl.pdf.
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our current injectable buprenorphine
coding under the OTP benefit would be
appropriate for several reasons,
including: the costs for furnishing these
drugs, as shown by similar ASP
payment limits for monthly Brixadi®
(J0578) and the two HCPCS codes for
Sublocade® (Q9991 and Q9992)
($1,616.346 and $1,874.902,
respectively, are comparable as reflected
in the April 2024 ASP file); the average
maintenance dosage for Sublocade®
(100 mg) is comparable to the median
monthly dosage for Brixadi® (96 mg)
and; both drugs have similar frequencies
and costs of administration (on a
monthly basis) with a fee paid to the
OTP for one administration of an
injection once a month. We believe that
our proposed payment methodology
would be consistent with section
1834(w)(2) of the Act, which allows the
Secretary to implement bundled
payments for OUD treatment services
with considerations to the type of
medication provided and the frequency
of the services, and thus permit multiple
bundles that represent injectable
buprenorphine (proposed GOTP2 and
G2069) and the frequency with which
injectable buprenorphine is
administered (weekly versus monthly).
We propose to still calculate the nondrug component of HCPCS code G2069
consistent with the methodology we use
to calculate the non-drug component,
which is specified at § 410.67(d)(2)(ii).
We are proposing to change the code
descriptor for HCPCS code G2069 to
take out references to a ‘‘weekly
bundle’’ to make it clear that the code
is to be billed on a monthly basis.
Specifically, we would revise the code
descriptor to state the following: HCPCS
code G2069 (Medication assisted
treatment, buprenorphine (injectable)
administered on a monthly basis;
bundle including dispensing and/or
administration, substance use
counseling, individual and group
therapy, and toxicology testing if
performed (provision of the services by
a Medicare-enrolled Opioid Treatment
Program)). Lastly, consistent with
current guidance in Chapter 39 of the
Medicare Claims Processing Manual, we
would still expect that HCPCS code
G2069 ‘‘would be billed for the week
during which the injection was
administered and that HCPCS code
G2074, which describes a bundle not
including the drug, would be billed
during any subsequent weeks that at
least one non-drug service is furnished
until the injection is administered again,
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at which time HCPCS code G2069
would be billed again for that week.’’ 450
For the weekly formulation of
Brixadi®, we propose to calculate a new
bundled payment described by GOTP2
(Medication assisted treatment,
buprenorphine (injectable) administered
on a weekly basis; weekly bundle
including dispensing and/or
administration, substance use
counseling, individual and group
therapy, and toxicology testing if
performed (provision of the services by
a Medicare-enrolled Opioid Treatment
Program). For the drug component of
HCPCS code GOTP2, we propose to base
the payment on a crosswalk to the
weekly Brixadi® formulation described
by HCPCS code J0577 (Injection,
buprenorphine extended release
(brixadi), less than or equal to 7 days of
therapy), which would also be based on
the payment methodology specified at
§ 410.67(d)(2)(i)(A) for implantable and
injectable medications, consistent with
the existing monthly injectable
buprenorphine bundle. We believe that
establishing a separate weekly bundled
payment reflecting the weekly
formulation of Brixadi® would more
appropriately pay for the subset of
beneficiaries who receive less than a
monthly dosage of injectable
buprenorphine on average, or who
choose to discontinue treatment for the
drug before the end of the month.
Additionally, establishing a separate
weekly bundled payment would
contribute to stabilizing the payment of
the drug component for the monthly
bundle of injectable buprenorphine
(G2069) since the ASP payment limit for
weekly Brixadi® costs less than the
payment for the drug component of
G2069 ($404.086 April 2024 ASP
payment limit versus $1,780.167 for the
CY 2024 payment rate of the drug
component of G2069) and may decrease
payment after the weekly Brixadi
payment limit is averaged into the drug
component of G2069®. Establishing a
separate weekly bundled payment is
also more appropriate because weekly
Brixadi® requires more frequent
administration costs than monthly
injectable buprenorphine (weekly
Brixadi® must be injected at least once
every 7 days compared to once a month
for Sublocade® and monthly Brixadi®).
Thus, a different bundle for weekly
Brixadi® may more closely reflect the
costs incurred by OTPs. Furthermore, as
noted above in this section, different
weekly doses are assigned to the same
HCPCS code J0577 (Injection,
buprenorphine extended release
450 https://www.cms.gov/files/document/chapter39-opioid-treatment-programs-otps.pdf.
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(brixadi), less than or equal to 7 days of
therapy) and have the same payment
limit regardless of the weekly dose.
Therefore, we do not believe it is
appropriate to propose an average
typical dose for the weekly formulation
of Brixadi® for purposes of calculating
the drug component of GOTP2 under
the OTP benefit.
Second, we propose to also establish
payment for the non-drug component of
GOTP2 consistent with the methodology
utilized for the monthly bundle of
injectable buprenorphine (G2069).
Specifically, we would continue to pay
for substance use counseling, individual
and group therapy, and toxicology
testing that are included in the non-drug
components for each of the bundled
payments reflecting an episode of care,
but we would include the Medicare
non-facility rate for administration of an
injection in our determination of the
non-drug component payment rate
based on CPT code 96372 (Therapeutic,
prophylactic, or diagnostic injection
(specify substance or drug);
subcutaneous or intramuscular).
Consistent with the payment amounts
for the non-drug component of other
bundled payments for an episode of
care, we also propose to continue to
update the value of this non-drug
component for GOTP2 by the GAF as
described in § 410.67(d)(4)(ii), and by
the MEI as described in
§ 410.67(d)(4)(iii).
We welcome comments on these
proposals to establish payment for the
weekly and monthly formulations of the
new injectable buprenorphine drug,
Brixadi®.
5. Clarification To Require an Opioid
Use Disorder Diagnosis on Claims for
OUD Treatment Services
Section 1861(s)(2)(HH) of the Act, as
amended by section 2005 of the
SUPPORT Act, implemented Medicare
coverage for ‘‘opioid use disorder
treatment services.’’ Section 1861(jjj)(1)
of the Act describes opioid use disorder
treatment services as items and services
that are furnished by an opioid
treatment program for the treatment of
opioid use disorder. Section 1834 of the
Act specifies payments to OTPs for
providing opioid use disorder treatment
services. We interpreted these statutory
provisions to mean that services paid to
OTPs under Medicare Part B must be for
the treatment of opioid use disorder.
Consequently, at § 410.67(a) we reflect
that those statutory provisions provide
for coverage and payment to OTPs for
OUD treatment services, which we
define at § 410.67(b).
In August of 2023, an Office of
Inspector General (OIG) report (A–09–
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22–03005) found that Medicare made
over $1.3 million in payments to 70
OTPs for OUD treatment services that
were claimed without an OUD
diagnosis.451 Of the claims paid without
an OUD diagnosis code, 39 percent were
for alcohol dependence, uncomplicated
(F1020), 7 percent were for cocaine
dependence, uncomplicated (F1420),
and 5 percent were for generalized
anxiety disorder (F411). As a result of
these findings, OIG recommended that
CMS ‘‘develop billing requirements for
OTPs to include OUD diagnosis codes
on claims for OUD treatment services to
indicate that enrollees have OUD
diagnoses and consider working with
MACs to implement a system edit to
ensure that OTP payments are made for
enrollees only when OUD diagnosis
codes are included on claims.’’ OIG also
stated that ‘‘requiring OTPs to include
OUD diagnosis codes on claims could
be a way for CMS to monitor whether
OTPs furnished OUD treatment services
to enrollees who had an OUD.’’ In our
response to the OIG report, we raised
that the lack of an OUD diagnosis code
on a claim is not conclusive evidence of
an improper claim because an OUD
diagnosis code is not required for
payment when an OTP submits a claim
for OUD treatment services. However,
we agreed to explore ways to educate
providers about including an OUD
diagnosis on claims.
We continue to monitor claims paid
by Medicare to OTPs for furnishing
OUD treatment services, including for
potential fraud and abuse. In analyzing
our claims data at the beginning of CY
2024, we found data indicating that the
majority of claims paid to OTPs have an
OUD diagnosis code appended, meaning
that only a small number of OTPs do not
append an OUD diagnosis code to
claims. However, we do intend to
ensure that payments made to OTPs are
in alignment with statutory
requirements, which is that payments
made must be for services furnished for
the treatment of an OUD.
Therefore, we are clarifying that all
claims submitted to Medicare, on Form
CMS–1450 for institutional providers,
and on Form CMS–1500 for professional
providers, or the electronic equivalents,
under the OTP benefit must include an
OUD diagnosis. These diagnosis codes
must apply to HCPCS G-codes
representing both the bundled payments
(G2067 through G2075) and add-on
codes to the bundled payments (G2076–
G2080, G2215–G2216, G1028, and
G0137). Applicable diagnosis codes for
an OUD that must be submitted on
451 https://oig.hhs.gov/oas/reports/region9/
92203005.asp.
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claims include ICD–10–CM codes in the
F11 range for ‘‘disorders related or
resulting from abuse or misuse of
opioids.’’ 452 CMS plans to issue
additional guidance on appending these
diagnosis codes to claims. We believe
clarifying these billing requirements is
consistent with CMS’s strategic pillars
to be a responsible steward of public
funds,453 and that these requirements
are consistent with statutory provisions
under sections 1861(s)(2)(HH),
1861(jjj)(1), and 1834 of the Act.
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, 2024, the Shared
Savings Program has 480 ACOs with
over 634,000 health care providers and
organizations providing care to over
10.8 million assigned beneficiaries,
making it the largest value-based care
program in the country.454 455 The policy
changes to the Shared Savings Program
finalized in the CY 2023 PFS final rule
(87 FR 69777 through 69979) and CY
2024 PFS final rule (88 FR 79093
through 79232) are expected to grow
participation in the program and
increase the number of beneficiaries
assigned to ACOs by up to four million
452 https://www.icd10data.com/ICD10CM/Codes/
F01–F99/F10-F19/F11-.
453 https://www.cms.gov/about-cms/what-we-do/
cms-strategic-plan.
454 Refer to CMS, Shared Savings Program Fast
Facts—As of January 1, 2024, available at https://
www.cms.gov/files/document/2024-shared-savingsprogram-fast-facts.pdf.
455 See CMS Press Release, ‘‘Participation
Continues to Grow in CMS’ Accountable Care
Organization Initiatives in 2024’’, January 29, 2024,
available at https://www.cms.gov/newsroom/pressreleases/participation-continues-grow-cmsaccountable-care-organization-initiatives-2024.
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in the next 10 years (that is, between
2024–2034).456 These policies are
expected to drive growth in
participation, particularly in rural and
underserved areas, promote equity, and
advance alignment across accountable
care initiatives, and are central to
achieving CMS’ goal of having 100
percent of people with Traditional
Medicare in a care relationship with
accountability for quality and total cost
of care by 2030.457 Of note, 19 newly
formed ACOs in the Shared Savings
Program are participating in a new,
permanent payment option beginning in
2024 that is enabling these ACOs to
receive more than $20 million in
advance investment payments (AIPs) for
caring for underserved communities.458
ACOs are now delivering care to people
with Traditional Medicare in 9,032
Federally Qualified Health Centers,
Rural Health Clinics, and critical access
hospitals, an increase of 27 percent from
2023.459
Section III.G. of this proposed rule
addresses changes to the Shared Savings
Program regulations to further advance
Medicare’s value-based care strategy of
growth, alignment, and equity and
includes changes to allow for timely
improvements to program policies and
operations.
We are proposing modifications to the
Shared Savings Program to require
ACOs, beginning in performance year
2025 and subsequent performance years,
to report the APM Performance Pathway
(APP) Plus quality measure set proposed
in section III.G.4. of this proposed rule.
The APP Plus quality measure set
would incrementally grow to comprise
of eleven measures, consisting of the six
measures in the existing APP quality
measure set and five newly proposed
456 Refer to 87 FR 69889. See also, 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.
457 For a description of CMS’ strategic vision and
objectives, see Seshamani M, Fowler E, BrooksLaSure C. ‘‘Building On The CMS Strategic Vision:
Working Together For A Stronger Medicare’’.
Health Affairs. January 11, 2022. Available at
https://www.healthaffairs.org/content/forefront/
building-cms-strategic-vision-working-togetherstronger-medicare. See also, 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).
458 Refer to CMS Press Release, ‘‘Participation
Continues to Grow in CMS’ Accountable Care
Organization Initiatives in 2024’’, January 29, 2024,
available at https://www.cms.gov/newsroom/pressreleases/participation-continues-grow-cmsaccountable-care-organization-initiatives-2024.
459 Ibid.
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measures from the Adult Universal
Foundation measure set that would be
incrementally incorporated into the APP
Plus quality measure set over
performance years 2025 through 2028.
We are also proposing to focus the
collection types available to Shared
Savings Program ACOs for reporting the
APP Plus quality measure set to eCQMs
and Medicare CQMs. In adopting the
APP Plus quality measure set, we are
also proposing several changes to the
methodology for calculating the MIPS
Quality performance category score for
Shared Savings Program ACOs reporting
the APP Plus quality measure set. These
include proposing that Shared Savings
Program ACOs that report the APP Plus
quality measure set and MIPS eligible
clinicians, groups, and APM Entities
that choose to report the APP Plus
quality measure set, will be required to
report on all measures in the APP Plus
quality measure set, as applicable;
establishing a Complex Organization
Adjustment for Virtual Groups and APM
Entities, including Shared Savings
Program ACOs, when reporting eCQMs;
and scoring Medicare CQMs using flat
benchmarks in their first 2 performance
periods in MIPS. Additionally, we are
proposing to extend the eCQM reporting
incentive for meeting the Shared
Savings Program quality performance
standard to performance year 2025 and
subsequent performance years.
Collectively, these proposals aim to
align the quality measures that Shared
Savings Program ACOs would be
required to report with the quality
measures under the Adult Universal
Foundation measure set incrementally
beginning in performance year 2025 and
prioritize the eCQM collection type as
the gold standard collection type that
underlies CMS’ Digital Quality
Measurement Strategic Roadmap while
using Medicare CQMs as the transition
step on our building block approach for
ACOs’ progress to adopt digital quality
measurement.
We propose to establish a new
‘‘prepaid shared savings’’ option to
assist eligible ACOs with a history of
earning shared savings. Eligible ACOs
that apply and are approved to receive
prepaid shared savings will receive
advances of earned shared savings that
they can use to make investments that
would aid beneficiaries, such as
investments in direct beneficiary
services and investments to improve
care coordination through staffing or
healthcare infrastructure. At least 50
percent of prepaid shared savings would
be reserved to be spent on direct
beneficiary services not otherwise
payable in Traditional Medicare, such
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as meals, dental, vision, hearing, and
Part B cost-sharing support.
Additionally, up to 50 percent of the
prepaid shared savings can be spent on
staffing and infrastructure. Further, we
propose refinements to advance
investment payment policies to allow
ACOs receiving advance investment
payments to voluntarily terminate from
the payment option while remaining in
the Shared Savings Program, and to
specify that if CMS terminates an ACO’s
participation agreement, the ACO must
repay any outstanding advance
investment payments it received.
We propose modifications to the
Shared Savings Program’s financial
methodology to encourage ACO
participation in the Shared Savings
Program by removing barriers for ACOs
serving underserved communities, and
by providing greater specificity and
clarification on how CMS would
perform certain financial calculations in
the Shared Savings Program. We would
ensure the benchmarking methodology
includes sufficient incentive for ACOs
serving underserved communities 460 to
enter and remain in the program
through the application of a proposed
health equity benchmark adjustment.
We propose to specify a calculation
methodology to account for the impact
of improper payments in recalculating
expenditures and payment amounts
used in Shared Savings Program
financial calculations, upon reopening a
payment determination pursuant to
§ 425.315(a). We propose to establish a
methodology for excluding payment
amounts for HCPCS and CPT codes
exhibiting significant, anomalous, and
highly suspect billing activity during CY
2024 or subsequent calendar years that
warrant adjustment. We also propose
modifications to provide clarity on the
methodology for capping the ACO’s risk
score growth and regional risk score
growth. Additionally, building off of a
comment solicitation in CY 2024 PFS
rulemaking, through a new request for
information in this proposed rule, we
are seeking comments on financial
arrangements that could allow for
higher risk and potential reward under
a revised ENHANCED track within the
Shared Savings Program, including the
460 As described in the CMS Framework for
Health Equity and consistent with Executive Order
13985 on Advancing Racial Equity and Support for
Underserved Communities Through the Federal
Government (86 FR 7009), the term ‘‘underserved
communities’’ refers to populations sharing a
particular characteristic, including geographic
communities that have been systematically denied
a full opportunity to participate in aspects of
economic, social, and civic life, as exemplified in
the definition of ‘‘equity.’’
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designs of and trade-offs between
financial model features.
We are proposing changes in
connection with Shared Savings
Program eligibility requirements and
application procedures. To better align
program policies with our goal of
increasing the number of beneficiaries
in an accountable care relationship with
a health care provider, we propose to
sunset the requirement that CMS
terminates the participation agreement
if the ACO’s population is not at least
5,000 by the end of the performance
year specified by CMS in its request for
a Corrective Action Plan (CAP) while
continuing to require ACOs to meet the
minimum threshold of 5,000 assigned
beneficiaries to begin a new agreement.
We are proposing to update provisions
of the Shared Savings Program
regulations on application procedures to
reflect the latest approach Antitrust
Agencies (the Department of Justice and
the Federal Trade Commission 461) use
to evaluate ACOs and enforce the
antitrust laws. We are proposing
changes to the Shared Savings Program
beneficiary assignment methodology, to
revise the definition of primary care
services to align with payment policy
proposals described elsewhere in this
proposed rule, and to broaden the
existing exception to the program’s
voluntary alignment policy to allow for
beneficiaries to be assigned to entities
participating in certain Innovation
Center ACO models.
We propose modifications to the
beneficiary information notification
requirements under
§ 425.312(a)(2)(v)(A) to reduce
administrative burden on ACOs while
maintaining beneficiary protections.
First, we propose to modify the
requirements for the timing of the
follow-up communication to a
beneficiary who has received the
standardized written notice under
§ 425.312(a)(2)(iii) or (iv). Under the
proposed approach, an ACO would be
required to provide the follow-up
communication within 180 days from
the date the standardized written notice
was provided, as opposed to no later
than the earlier of the beneficiary’s next
primary care service visit or 180 days
461 Refer to Withdrawn Final Policy Statement,
‘‘Statement of Antitrust Enforcement Policy
Regarding Accountable Care Organizations
Participating in the Medicare Shared Savings
Program,’’ available at https://www.justice.gov/
sites/default/files/atr/legacy/2011/10/20/
276458.pdf. See also, FTC Press Release, ‘‘Federal
Trade Commission Withdraws Health Care
Enforcement Policy Statements’’, July 14, 2023,
available at https://www.ftc.gov/news-events/news/
press-releases/2023/07/federal-trade-commissionwithdraws-health-care-enforcement-policystatements.
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from the date the standardized written
notice was provided. In addition, we
propose to modify § 425.312(a)(2)(iii) to
require ACOs under preliminary
prospective assignment with
retrospective reconciliation to provide
the standardized written notification to
a subset of the Medicare FFS beneficiary
population that is more likely to be
assigned to the ACO, when compared to
the population of beneficiaries who
must receive the written notification
under current § 425.312(a)(2)(iii). If
finalized, this proposal would reduce
the burden on ACOs and confusion for
beneficiaries resulting from the current
requirement under which ACOs are
required to send this notification to a
greater number of beneficiaries who
may not ultimately be assigned to the
ACO.
b. Statutory and Regulatory Background
on the Shared Savings Program
On March 23, 2010, the Patient
Protection and Affordable Care Act
(Pub. L. 111–148) was enacted, followed
by enactment of the Health Care and
Education Reconciliation Act of 2010
(Pub. L. 111–152) on March 30, 2010,
which amended certain provisions of
the Patient Protection and Affordable
Care Act (hereinafter collectively
referred to as ‘‘the Affordable Care
Act’’). Section 3022 of the Affordable
Care Act amended Title XVIII of the Act
(42 U.S.C. 1395 et seq.) by adding
section 1899 of the Act to establish the
Medicare Shared Savings Program 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). The Bipartisan
Budget Act of 2018 (Pub. L. 115–123),
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
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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;
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
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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 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), 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
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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, evisits, and telephonic communication.
We also clarified the applicability of the
program’s extreme and uncontrollable
circumstances policy to mitigate shared
losses for the period of the PHE for
COVID–19 starting in January 2020.
We have also made use of the annual
CY PFS rules to address quality
reporting for the Shared Savings
Program and certain other issues. 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), the CY 2023 PFS final rule
(87 FR 69779 and 69780), and the CY
2024 PFS final rule (88 FR 79094 and
79095). In the CY 2024 PFS final rule
(88 FR 79093 through 79232), we
finalized changes to Shared Savings
Program policies, including to: continue
to move ACOs toward digital
measurement of quality by revising the
quality performance standard and
reporting requirements under the APP
within the Quality Payment Program
(QPP); add a third step to the step-wise
beneficiary assignment methodology
under which we 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 related changes
to how we identify assignable
beneficiaries used in certain Shared
Savings Program calculations; update
the definition of primary care services
used for purposes of beneficiary
assignment to remain consistent with
billing and coding guidelines; refine the
financial benchmarking methodology
for ACOs in agreement periods
beginning on January 1, 2024, and in
subsequent years to (1) cap the risk
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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 our policies for the
newly established advance investment
payments (AIP); make updates to other
programmatic areas including the
program’s eligibility requirements; and
make timely technical changes to the
regulations for clarity and consistency.
Further, we also summarized comments
received in response to a comment
solicitation on potential future
developments to Shared Savings
Program policies, including
incorporating a track with higher risk
and potential reward than the
ENHANCED track.
Policies applicable to Shared Savings
Program ACOs for purposes of quality
reporting for other programs have also
continued to evolve based on changes in
the statute. For instance, the Medicare
Access and CHIP Reauthorization Act of
2015 (MACRA) (Pub. L. 114–10)
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.8. of
this proposed rule, we propose
modifications to the Shared Savings
Program’s policies, and describe
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comment solicitations. As a general
summary, we are proposing the
following changes to Shared Savings
Program policies to:
• Update Shared Savings Program
eligibility requirements and application
procedures, including the following
(section III.G.2 of this proposed rule):
++ Update compliance obligations for
the requirement that ACOs maintain at
least 5,000 assigned beneficiaries by the
end of the performance year specified
by CMS in its request for a CAP (section
III.G.2.b of this proposed rule).
++ Revise the requirement that newly
formed ACOs must agree to allow CMS
to share a copy of their application with
the Antitrust Agencies (section III.G.2.c
of this proposed rule).
• Revise the policies for determining
beneficiary assignment, including the
following (section III.G.3 of this
proposed rule):
++ Update the definition of primary
care services used in beneficiary
assignment at § 425.400(c) (section
III.G.3.a of this proposed rule).
++ Revise the Shared Savings Program
regulations to broaden a limited
exception to the program’s voluntary
alignment policy and allow a
voluntarily aligned Shared Savings
Program beneficiary to be claims-based
assigned to an entity participating in a
disease- or condition-specific CMS
Innovation Center model when that
model uses claims-based assignment
that is based on primary care and/or
other services and the Secretary has
determined that a waiver is necessary
solely for purposes of testing the model,
in order for beneficiaries with certain
diseases or conditions to benefit from
the focused attention and care
coordination related to the disease or
condition that an entity participating in
such a model can offer (section III.G.3.b
of this proposed rule).
• Revise the quality reporting and the
quality performance standard
requirements, including the following
(section III.G.4. of this proposed rule):
++ Propose to require Shared Savings
Program ACOs to report the APP Plus
quality measure set (section
III.G.4.b.(2)(a) of this proposed rule).
++ Propose to focus the collection
types available to Shared Savings
Program ACOs for reporting the APP
Plus quality measure set to eCQMs and
Medicare CQMs (section III.G.4.b.(2)(b)
of this proposed rule).
++ Propose that Shared Savings
Program ACOs that report the APP Plus
quality measure set and MIPS eligible
clinicians, groups, and APM Entities
that choose to report the APP Plus
quality measure set, will be required to
report on all measures in the APP Plus
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quality measure set, as applicable
(section III.G.4.c.(2)(a) of this proposed
rule).
++ Propose to establish a Complex
Organization Adjustment for Virtual
Groups and APM Entities, including
Shared Savings Program ACOs, when
reporting eCQMs (section III.G.4.c.(2)(b)
of this proposed rule).
++ Propose to score Medicare CQMs
using flat benchmarks in their first two
performance periods in MIPS (section
III.G.4.c.(2)(c) of this proposed rule).
++ Propose to extend the eCQM
reporting incentive for meeting the
Shared Savings Program quality
performance standard to performance
year 2025 and subsequent performance
years (section III.G.4.d of this proposed
rule).
• Allow eligible ACOs to receive
prepaid shared savings (section III.G.5
of this proposed rule).
• Refine AIP policies, including the
following (section III.G.6 of this
proposed rule):
++ Allow ACOs receiving advance
investment payments to voluntarily
terminate from the payment option
while remaining in the Shared Savings
Program (section III.G.6.a of this
proposed rule).
++ Codify a policy for recouping
advance investment payments from
ACOs whose participation agreements
are terminated by CMS (section III.G.6.b
of this proposed rule).
• Revise the policies on the Shared
Savings Program’s financial
methodology, including the following
(section III.G.7 of this proposed rule):
++ Apply a health equity benchmark
adjustment (HEBA) which would adjust
upward an ACO’s historical benchmark,
based on the number of beneficiaries
they serve who are dually eligible or
enrolled in the Medicare Part D LowIncome Subsidy (LIS). This would
encourage and sustain participation by
ACOs serving underserved populations
that do not benefit from existing
benchmark adjustments for regional
efficiency or from generating prior
savings (section III.G.7.b of this
proposed rule).
++ Establish a calculation
methodology to account for the impact
of improper payments in recalculating
expenditures and payment amounts
used in Shared Savings Program
financial calculations upon reopening a
payment determination pursuant to
§ 425.315(a) (section III.G.7.c of this
proposed rule).
++ Establish an approach to identify
significant, anomalous, and highly
suspect (SAHS) billing activity
occurring in CY 2024 or subsequent
calendar years, and specify approaches
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to mitigating the impact of the SAHS
billing activity on Shared Savings
Program financial calculations in CY
2024 or subsequent calendar years.
Under the proposed approach we would
exclude payment amounts from
expenditure and revenue calculations
for the relevant calendar year for which
the SAHS billing activity is identified,
as well as from historical benchmarks
used to reconcile the ACO for a
performance year corresponding to the
calendar year for which the SAHS
billing activity is identified (section
III.G.7.d of this proposed rule).
++ Seek comment on establishing a
higher risk/reward option than the
current ENHANCED track (section
III.G.7.e of this proposed rule).
++ Propose technical changes, for
consistency and clarity in provisions of
the Shared Savings Program regulations
on financial calculations, to align and
clarify the language used to describe
weights applied to the growth in ACO
and regional risk scores for each
Medicare enrollment type, as part of the
calculation for capping ACO and
regional risk score growth, respectively.
The weight for a given enrollment type
would be equal to the product of the
ACO’s historical benchmark
expenditures after the application any
adjustment applied under
§ 425.652(a)(8) of the regulations (that
is, the regional adjustment, prior savings
adjustment or proposed HEBA (if
finalized), or no adjustment) for that
enrollment type and the ACO’s
performance year assigned beneficiary
person years for that enrollment type
(section III.G.7.f of this proposed rule).
• Modify beneficiary notification
requirements, including the following
(section III.G.8 of this proposed rule):
++ ACOs must provide the follow-up
beneficiary communication no later
than 180 days after the date that the
ACO provided the standardized written
notice to the beneficiary (section
III.G.8.a of this proposed rule).
++ For ACOs that select preliminary
prospective assignment with
retrospective reconciliation, limit the
distribution of the standardized written
beneficiary information notification to
beneficiaries who are more likely to be
assigned to the ACO, when compared to
the beneficiaries who must receive the
written notification under current
regulations (section III.G.8.b of this
proposed rule).
Taken together, the Shared Savings
Program proposals in this proposed rule
are anticipated to improve ACOs’
incentives to join the program and
continue participating in future years
and earn shared savings. The proposals
are projected to reduce program
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61841
spending by $260 million in total over
the 10-year period 2025 through 2034.
These changes are anticipated to
support the goals outlined in the CY
2023 PFS final rule (87 FR 69777
through 69978) and CY 2024 PFS final
rule (88 FR 79093 through 79232) for
growing the program, with a particular
focus on including underserved
communities.
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 proposal to allow eligible ACOs
to receive prepaid shared savings; the
proposal to use a calculation
methodology to account for the impact
of improper payments in recalculating
expenditures and payment amounts for
certain Shared Savings Program
financial calculations, upon reopening
an ACO’s payment determination and
issuing a revised initial determination
pursuant to § 425.315(a); the proposal to
use a methodology for certain Shared
Savings Program financial calculations
to mitigate the impact of SAHS billing
activity occurring in CY 2024 or
subsequent calendar years; and the
proposed technical changes to the
provision describing how we calculate
the weights applied when capping
growth in regional risk scores as part of
the regional component 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
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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. Eligibility Requirements and
Application Procedures
a. Overview
We are proposing two modifications
to the Shared Savings Program
eligibility and application procedures
that will be implemented for
performance years beginning on or after
January 1, 2025. Specifically, we
propose the following, which are
discussed in more detail in sections (b)
and (c) below:
• Sunset the requirement after
January 1, 2025, at § 425.110(b)(2) that
CMS terminates the participation
agreement and the ACO is not eligible
to share in savings for that performance
year if the ACO’s assigned population is
not at least 5,000 by the end of the
performance year specified by CMS in
its request for a CAP and
• Revise the antitrust language in the
application procedures at
§§ 425.202(a)(3) and 425.224(a)(3) for
the Shared Savings Program.
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b. Monitoring Compliance With the
Requirement That ACOs Maintain at
Least 5,000 Assigned Beneficiaries
Section 1899(b)(2)(D) of the Act
requires participating ACOs to include
primary care ACO professionals that are
sufficient for the number of Medicare
FFS beneficiaries assigned to the ACO
and that at a minimum, the ACO shall
have at least 5,000 such beneficiaries
assigned to it. In the November 2011
final rule (76 FR 67808), in alignment
with the statutory requirement at
section 1899(b)(2)(D) of the Act, CMS
established that, at a minimum, an ACO
shall have at least 5,000 such
beneficiaries assigned to it to be eligible
to participate in the Shared Savings
Program under § 425.110. We described
the importance of maintaining at least
5,000 assigned beneficiaries with
respect to both eligibility of the ACO to
participate in the program and the
statistical stability for purposes of
calculating per capita expenditures and
assessing financial and quality
performance. We noted, however, that
we understood circumstances may
change during the agreement period,
and that an ACO’s assigned population
may vary accordingly.
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To enforce program requirements
under § 425.110, while still recognizing
that variations may occur for an ACO’s
assigned population, CMS generally
issues a warning notice and request the
ACO submit a Corrective Action Plan
(CAP) should the ACO’s assigned
population fall below 5,000
beneficiaries. Few ACOs have had a
beneficiary population that fell below
5,000. Between calendar year 2020 and
2023, based on the program’s
compliance monitoring review, 24
ACOs have been below this assignment
threshold at the start of one or more
performance years within an agreement
period, which led CMS to issue
compliance actions. Approximately 55
percent of these ACOs opted to
voluntarily terminate ahead of the CAP
deadline imposed by CMS, while
approximately 40 percent were able to
increase their beneficiary assignment
over the threshold and remain in the
program. Given additional time, more
ACOs likely would be able to increase
their beneficiary assignment, keeping
more beneficiaries in accountable care
relationships, and maintain their
participation in the Shared Savings
Program.
Separately, we had established a
policy in the December 2018 final rule
(83 FR 67925) providing for an ACO to
select the Minimum Savings Rate
(MSR)/Minimum Loss Rate (MLR) that
CMS would use when performing
shared savings and shared losses
calculations for the ACO. As we have
previously discussed, the MSR/MLR
protects against an ACO earning shared
savings or being liable for shared losses
when the change in expenditures
represents normal, or random, variation
rather than an actual change in
performance (see, for example, 83 FR
67923 through 67926).
In the December 2018 final rule (83
FR 67925 through 67929), we revised
§ 425.110(b) to provide for the use of a
variable MSR/MLR when performing
shared savings and shared losses
calculations if an ACO’s assigned
beneficiary population fell below 5,000
for the performance year regardless of
whether the ACO had previously
selected a fixed or variable MSR/MLR.
This policy protects the statistical
stability of the program’s expenditure
calculations. As an ACO’s assigned
beneficiary population decreases,
variability in the population’s
expenditures increases. We thus
expressed concern that the reduction in
the size of the ACO’s assigned
beneficiary population would cause
shared savings payments made to the
ACO to not reflect true cost savings, but
normal expenditure fluctuations (83 FR
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67926). The use of a variable MSR/MLR
thus made it more difficult for an ACO
under performance-based risk that falls
below the 5,000-beneficiary threshold to
earn shared savings or be responsible for
shared losses to ensure that the savings
or losses reflected the ACO’s actual
performance and not merely statistical
noise. This policy provided additional
protection to the Medicare Trust Funds
and greater protection for ACOs against
owing shared losses.
As described above, an ACO’s failure
to maintain at least 5,000 assigned
beneficiaries may result in compliance
actions, up to and including termination
of the ACO from the Shared Savings
Program. When originally developed,
this program policy was intended in
part to protect both CMS and the ACO
from variability in the expenditure
calculations caused by a small assigned
beneficiary population. With the MSR
and MLR adjustments finalized in the
December 2018 final rule, we developed
protections against issues with the
benchmark calculation for ACOs with
fewer assigned beneficiaries, which
provide adequate protection against
variability in the short term. The MSR
and MLR sliding scale varies based on
the number of beneficiaries assigned to
the ACO from 1 up to 60,000. Currently,
this adjustment to the MSR/MLR
protects both CMS and the ACO from
inappropriate over or underpayments,
reducing the financial risk of allowing
ACOs to continue to participate in the
Shared Savings Program if they
experience a reduction in assigned
beneficiaries.
In light of the effectiveness of the
variable MSR/MLR policy described
above, we are proposing to sunset the
requirement at § 425.110(b)(2) that CMS
will terminate an ACO’s participation
agreement and determine that an ACO
is not eligible to share in savings for that
performance year if an ACO’s assigned
population is not at least 5,000 by the
end of the performance year specified
by CMS in its request for a CAP.
Specifically, we propose to revise
§ 425.110(b)(2) to limit its application to
performance years starting before
January 1, 2025. Thus, for performance
years beginning on or after January 1,
2025, if the ACO’s assigned population
is not at least 5,000 by the end of the
performance year specified by CMS in
its request for a CAP, CMS will not be
required to terminate the participation
agreement.
This proposal would not modify the
requirement at § 425.110(a), which
implements the statutory requirement at
section 1899(b)(2)(D) of the Act that
ACOs have 5,000 beneficiaries at critical
points in CMS’s determination of the
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ACO’s eligibility to participate in the
Shared Savings Program, including: at
the time of application in order to be
eligible for the Shared Savings Program,
and at any point when an ACO elects to
renew its participation in the program.
As discussed in the November 2011
final rule (76 FR 67808), CMS has found
‘‘[a] minimum threshold is important
with respect to both the eligibility of the
ACO to participate in the program and
to the statistical stability for purposes of
calculating per capita expenditures and
assessing quality performance’’. A 5,000
beneficiary minimum, paired with a
variable MSR/MLR, enables ACOs to
have their work of improving
beneficiary care best reflected in their
financial performance and shared
savings results. Additionally, we would
retain § 425.110(b), which states that an
ACO may be subject to actions under
§§ 425.216 and 425.218 if its assigned
population falls below 5,000 at any time
during the performance year. This
proposed approach provides CMS with
additional flexibility in the compliance
actions that we take in working with
ACOs to help them return to the 5,000
beneficiary threshold.
The proposed modification aligns
with CMS’s broader goals to expand the
number of beneficiaries in accountable
care relationships. We anticipate this
flexibility will provide ACOs with
additional time and opportunities to
recruit additional providers and
suppliers to increase their assigned
beneficiary population rather than being
required to exit the Shared Savings
Program due to their beneficiary
attribution. We seek comment on this
proposal. If finalized, this proposed
change would be effective beginning on
January 1, 2025.
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c. Update Antitrust Language
Section 425.202(a)(3) requires that
ACOs that are newly formed after March
23, 2010, agree to allow CMS to share
a copy of their application with the
Antitrust Agencies (the Federal Trade
Commission (FTC) and the Department
of Justice (DOJ), as defined in the
Statement of Antitrust Enforcement
Policy Regarding Accountable Care
Organizations Participating in the
Medicare Shared Savings Program). This
policy has been in effect since the
enactment of the November 2011 final
rule (76 FR 67822). We stated at the
time that this policy was in the public
interest to harmonize the eligibility
criteria for ACOs that wished to
participate in the Shared Savings
Program with similar antitrust criteria
on clinical integration, because
competition among ACOs was expected
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to have significant benefits for Medicare
beneficiaries.
In 2023, both the DOJ and the FTC
withdrew the outdated Antitrust
Enforcement Policy Statement because
the policy no longer served its intended
purpose of providing useful guidance to
market participants.462 Instead, both
Antitrust Agencies have stated that they
will continue to vigorously enforce the
antitrust laws in the health care markets
by evaluating mergers and conduct that
harm competition on a case-by-case
basis.
As a result, we propose to modify the
Shared Savings Program eligibility
requirements that will be implemented
on January 1, 2025, by removing the
reference to the Antitrust Enforcement
Policy Statement in § 425.202(a)(3), and
also in § 425.224(a)(3). This proposal
aligns the Shared Savings Program with
the Antitrust Agencies’ decisions to
withdraw the Antitrust Enforcement
Policy Statement. We propose to edit
§ 425.202(a)(3) to state, ‘‘An ACO that
seeks to participate in the Shared
Savings Program must agree that CMS
can share a copy of their application
with the Antitrust Agencies.’’ Similarly,
we propose to edit § 425.224(a)(3) to
state, ‘‘An ACO that seeks to enter a new
participation agreement under the
Shared Savings Program must agree that
CMS can share a copy of its application
with the Antitrust Agencies.’’ We also
plan to remove guidance from the
Shared Savings Program website
detailing how an ACO could calculate
their share of services in each applicable
Primary Service Area (PSA), as
described in the Antitrust Policy
Statement, as this is no longer useful to
ACOs.
As we stated in 76 FR 67822, we
intend to coordinate closely with the
Antitrust Agencies throughout the
application process and the operation of
the Shared Savings Program to ensure
there are no detrimental impacts to
competition. CMS will share application
and participation information including
aggregate claims data regarding allowed
charges and fee-for-service payments for
all ACOs accepted in the Shared
Savings Program, with the Antitrust
Agencies needed to further any
462 U.S. Department of Justice, Press Release,
Justice Department Withdraws Outdated
Enforcement Policy Statements (Feb. 3, 2023),
available at https://www.justice.gov/opa/pr/justicedepartment-withdraws-outdated-enforcementpolicy-statements; Federal Trade Commission, Press
Release, Federal Trade Commission Withdraws
Health Care Enforcement Policy Statements (July
14, 2023), available at https://www.ftc.gov/newsevents/news/press-releases/2023/07/federal-tradecommission-withdraws-health-care-enforcementpolicy-statements.
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investigations or support their
enforcement of the antitrust laws.
We seek comment on this proposal. If
finalized, this proposed change would
be effective beginning on January 1,
2025.
3. Beneficiary Assignment Methodology
a. Proposed Revisions to the Definition
of Primary Care Services
(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
FR 69821 through 69825; 88 FR 79163
through 79174) 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, 2024, and
subsequent performance years, we
defined primary care services for
purposes of assigning beneficiaries to
ACOs under § 425.402 in
§ 425.400(c)(1)(viii).
(2) Proposed Revisions
Based on feedback from ACOs and
our further review of the HCPCS and
CPT codes that are currently recognized
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for payment under the PFS or that we
are proposing to recognize for payment
starting in CY 2025, 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 for the performance
year starting on January 1, 2025, and
subsequent performance years, in order
to remain consistent with billing and
coding under the PFS.
We propose to specify a revised
definition of primary care services used
for assignment in a new provision of the
Shared Savings Program regulations at
§ 425.400(c)(1)(ix) to include the list of
HCPCS and CPT codes specified in
§ 425.400(c)(1)(viii), as well as the
following additions: (1) Safety Planning
Interventions (HCPCS code GSPI1)
when the base code is also a primary
care service code, if finalized under
Medicare FFS payment policy; (2) PostDischarge Telephonic Follow-up
Contacts Intervention (HCPCS code
GFCI1), if finalized under Medicare FFS
payment policy; (3) Virtual Check-in
Service (CPT code 9X091), if finalized
under Medicare FFS payment policy; (4)
Advanced Primary Care Management
Services (HCPCS GPCM1, GPCM2, and
GPCM3), if finalized under Medicare
FFS payment policy; (5) Cardiovascular
Risk Assessment and Risk Management
Services (HCPCS codes GCDRA and
GCDRM), if finalized under Medicare
FFS payment policy; (6)
Interprofessional Consultation Services
(CPT codes 99446, 99447, 99448, 99449,
99451, 99452); (7) Direct Care Caregiver
Training Services (HCPCS codes
GCTD1, GCTD2 and GCTD3), if
finalized under Medicare FFS payment
policy; and (8) Individual Behavior
Management/Modification Caregiver
Training Services (HCPCS codes GCTB1
and GCTB2), if finalized under
Medicare FFS payment policy.
We propose that the new provision at
§ 425.400(c)(1)(ix) would be applicable
for use in determining beneficiary
assignment for the performance year
starting on January 1, 2025, and
subsequent performance years.
The following provides additional
information about the CPT and HCPCS
codes that we are proposing to add to
the definition of primary care services
used for purposes of beneficiary
assignment:
• Safety Planning Interventions (SPI)
(HCPCS code GSPI1 (Safety planning
interventions, including assisting the
patient in the identification of the
following personalized elements of a
safety plan: recognizing warning signs of
an impending suicidal crisis; employing
internal coping strategies; utilizing
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social contacts and social settings as a
means of distraction from suicidal
thoughts; utilizing family members,
significant others, caregivers, and/or
friends to help resolve the crisis;
contacting mental health professionals
or agencies; and making the
environment safe; (List separately in
addition to an E/M visit or
psychotherapy)): In section II.I of this
proposed rule, we are proposing under
the PFS to create an add-on G-code that
would be billed along with an E/M visit
or psychotherapy visit when safety
planning interventions are personally
performed by the billing practitioner in
a variety of settings. Safety planning
interventions involve a person working
with a clinician to develop a
personalized list of coping strategies
and sources of support that the person
could use in the event of experiencing
thoughts of harm to themselves or
others. This is not a suicide risk
assessment, but rather, an intervention
provided to people determined to have
elevated risk. Safety planning
interventions have also been used to
reduce the risk of suicide. The basic
components of a safety plan include the
following: (1) recognizing warning signs
of an impending suicidal crisis or
actions that increase the risk of
overdose; (2) employing internal coping
strategies; (3) utilizing social contacts
and social settings as a means of
distraction from suicidal thoughts and/
or taking steps to reduce the risk of
suicide; (4) utilizing family members or
friends to help resolve the crisis; (5)
contacting mental health professionals,
crisis services, or agencies; and (6)
making the environment safe, including
restricting access to lethal means, if
applicable.
Refer to section II.I of this proposed
rule for detailed, technical discussion
regarding the proposed description,
payment, and utilization of this HCPCS
code.
In the CY 2019 PFS final rule (83 FR
59965 through 59966), we finalized the
addition of prolonged evaluation and
management or psychotherapy
service(s) beyond the typical service
time of the primary procedure (CPT
codes 99354 and 99355) to the
definition of primary care services used
for purposes of assignment because
these two codes are ‘‘add-on codes’’ that
describe additional resource
components of a broader service
furnished in the office or other
outpatient setting that are not accounted
for in the valuation of the base codes.
For the same reason, we believe it
would be appropriate to also include
HCPCS code GSPI1, if finalized under
Medicare FFS policy since GSPI1 is
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being proposed as an add-on service to
an E/M or psychotherapy visit.
Evaluation and management visits are
included in the definition of primary
care services used for purposes of
assignment and so we believe it would
be appropriate to also include GSPI1,
when billed with an E/M visit, in the
definition of primary care services used
for purposes of assignment to assign
beneficiaries more accurately to ACOs
participating in the Shared Savings
Program. We further believe the services
billed under this code reflect the types
of services we expect primary care
providers to provide in order to improve
continuity of care. Including Safety
Planning Intervention services in the
definition of primary care services used
for purposes of assignment would also
align with the CMS Behavioral Health
Strategy, the mission of which is to
ensure that high-quality behavioral
health services and supports are
accessible to Medicare beneficiaries.
We note that, as proposed, HCPCS
code GSPI1 could also be billed with
psychotherapy services, which are not
considered for purposes of beneficiary
assignment under § 425.400(c).
Therefore, we propose to include the
allowed charges for HCPCS code GSPI1,
for purposes of assigning beneficiaries
to ACOs, only when billed with a
service which is also included in the
definition of primary care services.
• Post-Discharge Telephonic Followup Contacts Intervention (FCI) (HCPCS
code GFCI1: Post discharge telephonic
follow-up contacts performed in
conjunction with a discharge from the
emergency department for behavioral
health or other crisis encounter, per
calendar month). In section II.I of this
proposed rule, we describe FCI as a
specific protocol of services for
individuals with suicide risk involving
a series of telephone contacts between a
provider and person in the weeks and
sometimes months following discharge
from the emergency department and
other relevant care settings, that occurs
when the person is in the community
and is designed to reduce the risk of
subsequent adverse outcomes. FCI calls
are typically 10–20 minutes in duration
and aim to encourage use of the Safety
Plan (as needed in a crisis) and updating
it to optimize effectiveness, expressing
psychosocial support, and helping to
facilitate engagement in any indicated
follow-up care and services. We are
proposing to create a monthly billing
code to describe the specific protocols
involved in furnishing post-discharge
telephonic follow-up contacts that are
performed in conjunction with a
discharge from the emergency
department for a crisis encounter, as a
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bundled service describing four calls in
a month, each lasting between 10–20
minutes. We are proposing to price this
service based on a direct crosswalk to
CPT code 99426 (Principal care
management; first 30 minutes of clinical
staff time directed by a physician or
other qualified healthcare professional)
because we believe the work would be
similar in nature and intensity.
Refer to section II.I. of this proposed
rule for detailed, technical discussion
regarding the proposed description,
payment, and utilization of this HCPCS
code.
These services are similar to TCM
services (CPT codes 99495 and 99496),
which are included in the definition of
primary care services used for purposes
of assignment under § 425.400(c), in that
these services help eligible people
transition back to a community setting
after a stay at certain facility types like
TCM. Similar to the rationale described
December 2014 proposed rule (79 FR
72792) and later finalized in the June
2015 final rule (80 FR 32746 through
32748) where we finalized the inclusion
of TCM services in the definition of
primary care services used for purposes
of assignment, providing separate
payment for the work of community
physicians and practitioners in treating
a patient following discharge from a
hospital or nursing facility would
ensure better continuity of care for these
patients and help reduce avoidable
readmissions. Therefore, we believe that
FCI services should also be included in
the definition of primary care services
used for beneficiary assignment since
FCI services are designed to assist in the
transition from the emergency
department into the community. We
believe the services billed under this
code reflect the types of services we
expect primary care providers to
provide in order to improve care
coordination and care management.
Thus, we believe that FCI services
should also be included.
Further, in determining the
recommended pricing for HCPCS code
GFCI1, we recommend pricing this
service based on a direct crosswalk to
Principal Care Management (PCM)
service (CPT code 99426) because we
believe the work would be similar in
nature, as well as time and intensity. In
the CY 2021 PFS final rule (85 FR
84749), we finalized the inclusion of
HCPCS codes G2064 and G2065 in the
definition of primary care services used
for purposes of assignment since we
expect that most services billed under
these codes will be billed by specialists
who are focused on managing patients
with a single complex chronic condition
requiring substantial care management.
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These HCPCS codes were replaced by
CPT codes 99424, 99425, 99426, and
99427 in the CY 2022 PFS final rule (86
FR 65275). PCM services (CPT codes
99424, 99425, 99426, and 99427 and
HCPCS codes G2064 and G2065) are
included in the definition of primary
care services used for purposes of
assignment and since FCI services are
similar in nature, time, and intensity to
PCM services, we believe it would be
appropriate to include these services in
the definition of primary care services
used for purposes of assignment.
Including FCI services in the definition
of primary care services used for
purposes of assignment would also align
with the CMS Behavioral Health
Strategy as the FCI services are designed
to support beneficiaries with follow-up
care related to suicide risk.
• Virtual Check-in Service (CPT code
9X091):
++ CPT code 9X091 (Brief
communication technology-based
service (e.g., virtual check-in) by a
physician or other qualified health care
professional who can report evaluation
and management services, provided to
an established patient, not originating
from a related evaluation and
management service provided within
the previous 7 days nor leading to an
evaluation and management service or
procedure within the next 24 hours or
soonest available appointment, 5–10
minutes of medical discussion).
The CPT Editorial Panel established a
new CPT code 9X091 describing a brief
virtual check-in encounter that is
intended to evaluate the need for a more
extensive visit. The code descriptor for
CPT code 9X091 mirrors that of existing
HCPCS code G2012 (Brief
communication technology-based
service, e.g., virtual check-in, by a
physician or other qualified health care
professional who can report evaluation
and management services, provided to
an established patient, not originating
from a related E/M service provided
within the previous 7 days nor leading
to an E/M service or procedure within
the next 24 hours or soonest available
appointment; 5–10 minutes of medical
discussion) and, per the CPT Editorial
Panel materials, is intended to replace
that code. HCPCS code G2012 is
included in the Shared Savings Program
definition of primary care services used
for purposes of assignment.
In section II.E of this proposed rule,
we are proposing separate payment for
CPT code 9X091. Because the code
description for CPT code 9X091 mirrors
HCPCS code G2012 and because, per
CPT Editorial Panel materials, is
intended to replace HCPCS code G2012,
we are proposing to make CPT code
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9X091 separately payable under
Medicare. We note we are proposing to
delete HCPCS code G2012 for purposes
of Medicare PFS payment policy,
however, HCPCS code G2012 will
continue to be included in the
definition of primary care services used
for purposes of assignment, consistent
with how deleted CPT and HCPCS
codes have been handled historically
and to allow for consistency with
calculating historical benchmarks.
We propose that we would include
CPT code 9X091 in the definition of
primary care services used for purposes
of assignment as the code description of
brief communication technology-based
service mirrors the description of
HCPCS code G2012, which is included
in the definition of primary care
services used for purposes of
assignment since these services are
furnished to established patients by
physicians or qualified health care
professionals that can report E/M
services in lieu of an in person primary
care visit (85 FR 84753). Since CPT code
9X091 is a direct replacement of HCPCS
code G2012, 9X091 would be included
in the definition of primary care
services used for purposes of
assignment, under proposed
§ 425.400(c)(1)(ix)(C). In the CY 2022
Physician Fee Schedule file rule (86 FR
65277 through 65279), we finalized a
policy wherein we would incorporate
into the definition of primary care
services a permanent CPT code when it
directly replaces another CPT code or a
temporary HCPCS code (for example, a
G-code) that is already included in the
definition of primary care services for
purposes of determining beneficiary
assignment under the Shared Savings
Program. Additionally, CPT code
9X091, per the CPT Editorial Panel
materials, is intended to be reported
instead of HCPCS code G2012, which is
already included in the definition of
primary care services used for purposes
of assignment. We further believe the
services billed under this code reflect
the types of services we expect primary
care providers to provide in order to
improve care coordination and care
management.
We explained that this approach
would help to ensure the appropriate
identification of primary care services
used in the Shared Savings Program’s
assignment methodology by allowing for
the immediate inclusion of replacement
CPT codes in the determination of
beneficiary assignment and lead to
continuity in the assignment of
beneficiaries receiving those services
based on current coding. This
continuity would improve predictability
for ACOs, while also increasing the
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consistency of care coordination for
their assigned beneficiaries. We further
finalized that such replacement codes
would be incorporated into the
definition of the primary care services
for purposes of determining beneficiary
assignment for the performance year,
when the assignment window for a
benchmark or performance year (as
defined in § 425.20) includes any day
on or after the effective date of the
replacement code for payment purposes
under FFS Medicare. CPT code 9X091
has an effective date of January 1, 2025.
• Advanced Primary Care
Management (HCPCS codes GPCM1,
GPCM2, and GPCM3);
(1) HCPCS code GPCM1: (Advanced
primary care management services
provided by clinical staff and directed
by a physician or other qualified health
care professional who is responsible for
all primary care and serves as the
continuing focal point for all needed
health care services, per calendar
month, with the following elements, as
appropriate:
• Consent;
++ Inform the patient regarding
availability of the service; that only one
practitioner can furnish and be paid for
the service during a calendar month; of
the right to stop the services at any time
(effective at the end of the calendar
month); and that cost sharing may
apply.
++ Document in patient’s medical
record that consent was obtained.
• Initiation during a qualifying visit
for new patients or patients not seen
within 3 years;
• Provide 24/7 access for urgent
needs to care team/practitioners,
including providing patients/caregivers
with a way to contact health care
professionals in the practice to discuss
urgent needs regardless of the time of
day or day of week;
• Continuity of care with a designated
member of the care team with whom the
patient is able to schedule successive
routine appointments;
• Deliver care in alternative ways to
traditional office visits to best meet the
patient’s needs, such as home visits,
and/or expanded hours;
• Overall comprehensive care
management;
++ Systematic needs assessment
(medical and psychosocial).
++ System-based approaches to
ensure receipt of preventive services.
++ Medication reconciliation,
management and oversight of selfmanagement.
• Development, implementation,
revision, and maintenance of an
electronic patient-centered
comprehensive care plan;
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++ Care plan is available timely
within and outside the billing practice
as appropriate to individuals involved
in the beneficiary’s care, can be
routinely accessed and updated by care
team/practitioner, and copy of care plan
to patient/caregiver.
• Coordination of care transitions
between and among health care
providers and settings, including
referrals to other clinicians and followup after an emergency department visit
and discharges from hospitals, skilled
nursing facilities or other health care
facilities as applicable;
++ Ensure timely exchange of
electronic health information with other
practitioners and providers to support
continuity of care.
++ Ensure timely follow-up
communication (direct contact,
telephone, electronic) with the patient
and/or caregiver after an emergency
department visit and discharges from
hospitals, skilled nursing facilities, or
other health care facilities, within 7
calendar days of discharge, as clinically
indicated.
• Ongoing communication and
coordinating receipt of needed services
from practitioners, home- and
community-based service providers,
community-based social service
providers, hospitals, and skilled nursing
facilities (or other health care facilities),
and document communication
regarding the patient’s psychosocial
strengths and needs, functional deficits,
goals, preferences, and desired
outcomes, including cultural and
linguistic factors, in the patient’s
medical record;
• Enhanced opportunities for the
beneficiary and any caregiver to
communicate with the care team/
practitioner regarding the beneficiary’s
care through the use of asynchronous
non-face-to-face consultation methods
other than telephone, such as secure
messaging, email, internet, or patient
portal, and other communicationtechnology based services, including
remote evaluation of pre-recorded
patient information and
interprofessional telephone/internet/
EHR referral service(s), to maintain
ongoing communication with patients,
as appropriate;
++ Ensure access to patient-initiated
digital communications that require a
clinical decision, such as virtual checkins and digital online assessment and
management and E/M visits (or e-visits).
• Analyze patient population data to
identify gaps in care and offer
additional interventions, as appropriate;
• Risk stratify the practice population
based on defined diagnoses, claims, or
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other electronic data to identify and
target services to patients;
• Be assessed through performance
measurement of primary care quality,
total cost of care, and meaningful use of
Certified EHR Technology.
(2) HCPCS code GPCM2 (Advanced
primary care management services for a
patient with multiple (two or more)
chronic conditions expected to last at
least 12 months, or until the death of
the patient, which place the patient at
significant risk of death, acute
exacerbation/decompensation, or
functional decline, provided by clinical
staff and directed by a physician or
other qualified health care professional
who is responsible for all primary care
and serves as the continuing focal point
for all needed health care services, per
calendar month, with the elements
included in GPCM1, as appropriate),
and
(3) HCPCS code GPCM3 (Advanced
primary care management services for a
patient who is a Qualified Medicare
Beneficiary with multiple (two or more)
chronic conditions expected to last at
least 12 months, or until the death of
the patient, which place the patient at
significant risk of death, acute
exacerbation/decompensation, or
functional decline, provided by clinical
staff and directed by a physician or
other qualified health care professional
who is responsible for all primary care
and serves as the continuing focal point
for all needed health care services, per
calendar month, with the elements
included in GPCM1, as appropriate).
In section II.G. of this proposed rule,
we are proposing to establish coding
and make payment under the PFS for a
newly defined set of APCM services as
described and defined by three HCPCS
codes (GPCM1, GPCM2, and GPCM3) to
recognize the resource costs associated
with furnishing services using an
‘‘advanced primary care approach’’
supported by a team-based care
structure under the PFS. Delivery of
care using an advanced primary care
model involves restructuring of the
primary care team, which includes the
billing practitioner and the auxiliary
personnel under their general
supervision, within practices. This
restructuring creates several advantages
for patients, and provides more broad
accessibility and alternative methods for
patients to communicate with their care
team/practitioner about their care
outside of in-person visits (for example,
virtual, asynchronous interactions, such
as online chat), which can lead to more
timely and efficient identification of,
and responses to, health care needs (for
example, practitioners can route
patients to the optimal clinician and
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setting—to a synchronous visit, an
asynchronous chat, or a direct referral to
the optimal site of care). Practitioners
using an advanced primary care
delivery model can more easily
collaborate across clinical disciplines
through remote interprofessional
consultations with specialists, as well as
standardize condition management into
evidence-based clinical workflows,
which allow for closed-loop follow-up
and more real-time management for
patients with acute or evolving complex
issues, partner on complex decisions,
and personalize their patients’ care
plans.
Specifically, we are proposing to
adopt specific coding and payment
policies for APCM services for use by
practitioners who are providing services
under this specific model of advanced
primary care, when the practitioner is
the continuing focal point for all needed
health care services and responsible for
all primary care services.
Providing care using an advanced
primary care delivery model involves
resource costs associated with
maintaining certain practice capabilities
and continuous readiness and
monitoring activities to support a teambased approach to care, where
significant resources are used on virtual,
asynchronous patient interactions,
collaboration across clinical disciplines,
and real-time management of patients
with acute and complex concerns that
are not fully recognized or paid for by
the existing care management codes. As
the delivery of primary care has evolved
to embrace advanced primary care more
fully, we believe that it is prudent to
now adopt specific coding and payment
policies to better recognize the resources
involved in care management under an
advanced primary care delivery model.
We are seeking to ensure that the
APCM codes would fully and
appropriately capture the care
management and CTBS services that are
characteristic of the changes in medical
practice toward advanced primary care,
as demonstrated in select CMS
Innovation Center models. As we do for
CCM and PCM services, we propose to
require for APCM services that the
practitioner provide an initiating visit
and obtain beneficiary consent (see
section II.G.2.c.(1) and II.G.2.c.(2) of this
proposed rule). We are proposing to
incorporate as elements of APCM
services ‘‘Management of Care
Transitions’’ and ‘‘Enhanced
Communications Opportunities.’’ For
the ‘‘Management of Care Transitions’’
APCM service element, we are
proposing to specify timely follow-up
during care transitions (see section
II.G.2.c.(6) of this proposed rule). For
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the ‘‘Enhanced Communications
Opportunities’’ APCM service element,
we are proposing to incorporate digital
access through CTBS services, such as
virtual check-ins and remote evaluation
of images, to maintain ongoing
communication with the patient (see
section II.G.2.c.(8) of this proposed
rule). We are also proposing to specify
for APCM services the practice-level
characteristics and capabilities that we
believe to be inherent to, and
necessarily present when a practitioner
is providing covered services using, the
‘‘advanced primary care’’ model.
Included in the service descriptors for
GPCM1, GPCM2, and GPCM3 are
proposed practice-level capabilities that
reflect care delivery using an advanced
primary care model that focused around
24/7 access and continuity of care (see
section II.G.2.c.(3) of this proposed
rule), patient population-level
management (see section II.G.2.c.(9) of
this proposed rule), and performance
measurement (see section II.G.2.c.(10) of
this proposed rule). We believe these
practice capabilities are indicative of,
and necessary to, care delivery using the
advanced primary care model.
Refer to section II.G. of this proposed
rule for detailed, technical discussion
regarding the proposed description,
payment and utilization of these HCPCS
codes as well as information about
requirements for billing providers
participating in ACOs.
As described in section II.G., HCPCS
codes GPCM1 through GPCM3 would
describe APCM services furnished per
calendar month, following the initial
qualifying visit (see section II.G.2.c.(1)
for more on the initiating visit).
Physicians and NPPs, including nurse
practitioners (NPs), physician assistants
(PAs), certified nurse midwives (CNMs)
and clinical nurse specialists (CNSs),
could bill for APCM services. As we
describe in more detail in section
II.G.2.c., within the code descriptors for
GPCM1, GPCM2, and GPCM3, we are
including the elements of the scope of
service for APCM as well as the
capabilities and requirements that we
believe to be inherent to care delivery
by the practitioner using an advanced
primary care model, and necessary to
fully furnish and, therefore, bill for
APCM services.
We are proposing that the practitioner
who bills for APCM services must
intend to be responsible for the patient’s
primary care and serve as the
continuing focal point for all needed
health care services. We anticipate that
most practitioners furnishing APCM
services would be managing all the
patient’s health care services over the
month and have either already been
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providing ongoing care for the patient or
have the intention of being responsible
for the patient’s primary care and
serving as the continuing focal point for
all of the patient’s health care services.
As detailed in sections II.G.2.b. through
II.G.2.d., this proposed coding and
payment will incorporate elements of
several specific, existing care
management and communication
technology-based services (CTBS) into a
bundle of services, that reflects the
essential elements of the delivery of
advanced primary care, for payment
under the PFS starting in 2025.
These new codes are designed to
bundle the individual utilization of
codes that are already included in the
definition of primary care services used
for purposes of assignment, specifically
CCM (CPT codes 99437, 99487, 99489,
99490, 99491, and 99439 and HCPCS
codes G0506 and G2058), PCM (CPT
codes 99424, 99425, 99426, and 99427
and HCPCS codes G2064 and G2065),
TCM (CPT codes 99495 and 99496),
remote evaluation of patient videos/
images (HCPCS code G2010), and
virtual check-in and e-visits (HCPCS
codes G2012 and G2252). These new
codes also bundle IPC (CPT Codes
99446, 99447, 99448, 99449, 99451,
99452), which we are proposing to
include in the definition of primary care
services used for purposes of
assignment in this section of the rule.
Further, as proposed, this new APCM
bundle represents a broader application
of advanced primary care and
incorporates elements included in care
management and CTBS services. We
believe the services billed under these
codes reflect the types of services we
expect primary care providers to
provide in order to improve care
coordination and care management and
so it would be appropriate to include
HCPCS codes GPCM1, GPCM2, and
GPCM3 in the definition of primary care
services used for purposes of
assignment since these HCPCS codes
bundle services furnished under CPT
and HCPCS codes already included in
the definition of primary care services
used for purposes of assignment.
As described in section II.G, we
anticipate that these codes would
mostly be used by primary care
specialties, such as general medicine,
geriatric medicine, family medicine,
internal medicine, and pediatrics, or in
some instances, certain specialists
functioning as primary care
practitioners—for example, an OB/GYN
or a cardiologist. Since primary care
specialties, such as general medicine,
geriatric medicine, family medicine,
internal medicine, and pediatrics are
primary care physicians (as defined in
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§ 425.20) and OB/GYN or a cardiologist
are two of the specialty designations (as
described in § 425.402(c)) used for
purposes of assignment we believe it
would be appropriate to include HCPCS
codes GPCM1, GPCM2, and GPCM3 in
the definition of primary care services
used for purposes of assignment.
Inclusion of these APCM services in the
definition of primary care services used
for purposes of assignment would also
strengthen and invest in primary care in
alignment with the goals of the U.S.
Department of Health and Human
Services (HHS) Initiative to Strengthen
Primary Care.463 We also believe that
updating the definition of primary care
services used for purposes of
assignment to include the APCM bundle
would increase the accuracy of
assignment based on the provision of
primary care.
• Cardiovascular Risk Assessment
and Risk Management—
++ Cardiovascular Disease Risk
Assessment HCPCS code GCDRA
(Administration of a standardized,
evidence-based Atherosclerotic
Cardiovascular Disease (ASCVD) Risk
Assessment for patients with ASCVD
risk factors on the same date as an E/
M visit, 5–15 minutes, not more often
than every 12 months): As described in
section II.G. of this proposed rule, we
are proposing a new stand-alone HCPCS
code, GCDRA, to identify and value the
work involved in administering an
ASCVD risk assessment when medically
reasonable and necessary in relation to
an E/M visit. Atherosclerotic
Cardiovascular Disease (ASCVD) Risk
Assessment refers to a review of the
individual’s demographic factors,
modifiable risk factors for CVD, and risk
enhancers for CVD.
We are proposing that the ASCVD risk
assessment must be furnished by the
practitioner on the same date they
furnish an E/M visit, as the ASCVD risk
assessment would be reasonable and
necessary when used to inform the
patient’s diagnosis, and treatment plan
established during the visit. ASCVD risk
assessment is reasonable and necessary
for a patient who has at least one
predisposing condition to
cardiovascular disease that may put
them at increased risk for future ASCVD
diagnosis.
++ Atherosclerotic Cardiovascular
Disease Prevention Risk Management
Services HCPCS code GCDRM
(Atherosclerotic Cardiovascular Disease
(ASCVD) risk management services with
463 Refer to: U.S. Department of Health and
Human Services. (2023). HHS is Taking Action to
Strengthen Primary Care. https://www.hhs.gov/
sites/default/files/primary-care-issue-brief.pdf.
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the following required elements: patient
is without a current diagnosis of
ASCVD, but is determined to be at
medium or high risk for CVD (>15
percent in the next 10 years) as
previously determined by the ASCVD
risk assessment; ASCVD-Specific care
plan established, implemented, revised,
or monitored that addresses risk factors
and risk enhancers and must
incorporate shared decision-making
between the practitioner and the
patient; clinical staff time directed by
physician or other qualified health care
professional; per calendar month). As
described in section II.G of this
proposed rule, 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 healthcare
professionals, especially in the context
of evolving changes in medical practice
using evidence-based models of care,
such as the Million Hearts® model. We
are proposing to establish a G-code,
GCDRM, for ASCVD risk management
services which refers to the
development, implementation, and
monitoring of individualized care plans
for reducing cardiovascular risk,
including shared decision-making and
the use of the ‘‘ABCS’’ of cardiovascular
risk reduction, as well as counseling
and monitoring to improve diet and
exercise.
We believe that ASCVD risk
management services include
continuous care and coordination to
reduce or eliminate further elevation of
ASCVD risk over time, and potentially
prevent the development of future
cardiovascular disease diagnoses or
first-time heart attacks or strokes.
Physicians and Non-Physician
Practitioners (NPPs) who can furnish E/
M services could bill for ASCVD risk
management services. We anticipate
that ASCVD risk management services
would ordinarily be provided by
clinical staff incident to the professional
services of the billing practitioner in
accordance with our regulation at
§ 410.26. We are proposing that ASCVD
risk management services would be
considered a ‘‘designated care
management service’’ under
§ 410.26(b)(5) and, as such, could be
provided by auxiliary personnel under
the general supervision of the billing
practitioner.
Refer to section II.G of this proposed
rule for detailed, technical discussion
regarding the proposed description,
payment and utilization of HCPCS
codes GCDRA and GCDRM.
Because HCPCS codes GCDRA and
GCDRM are proposed to be care
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management services similar to CCM
(CPT codes 99437, 99439, 99487, 99489,
99490, and 99491) which are included
in the Shared Savings Program
definition of primary care services used
for purposes of assignment, we believe
it would be consistent and appropriate
to include GCDRA and GCDRM in the
definition of primary care services used
for purposes of assignment. In earlier
rulemaking, we finalized the inclusion
of CCM CPT codes 99487, 99489, 99490,
and 99491 (codes for chronic care
management) in the definition of
primary care services for the Shared
Savings Program. Refer to the June 2015
final rule (80 FR 32746 through 32748),
CY 2018 PFS final rule (82 FR 53212
through 53213), and CY 2021 PFS final
rule (85 FR 84749 through 84750 and
84754). ‘‘Complex’’ CCM services (CPT
codes 99487 and 99489) and ‘‘noncomplex’’ CCM services (CPT codes
99490 and 99491) share a common set
of service elements, including the
following: (1) Initiating visit, (2)
structured recording of patient
information using certified electronic
health record technology (EHR), (3) 24/
7 access to physicians or other qualified
health care professionals or clinical staff
and continuity of care, (4)
comprehensive care management
including systematic assessment of the
patient’s medical, functional, and
psychosocial needs, (5) comprehensive
care plan including a comprehensive
care plan for all health issues with
particular focus on the chronic
conditions being managed, and (6)
management of care transitions.
Elements of care management services
include: (1) an initial visit, which can be
an E/M service, Annual Wellness Visit
(AWV) or initial preventive physical
exam (IPPE or ‘‘Welcome to Medicare’’);
(2) continuity of care with a designated
practitioner; (3) comprehensive care
management; (4) comprehensive care
plan; (5) management of care
transitions; and (6) care coordination. In
the November 2011 final rule (76 FR
67852 through 67853), we finalized the
inclusion of E/M services, the AWV,
and the IPPE since those services aligns
the definition of primary care services
with the definition in section 5501 of
the Affordable Care Act. Because care
management, E/M services, the AWV,
and the IPPE are all included in the
definition of primary care services used
for purposes of assignment, we believe
GCDRA and GCDRM reflect the types of
services we expect primary care
providers to provide in order to improve
care coordination and care management.
Additionally, GCDRA and GCDRM are
care and risk management services that
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include elements of continuous and
coordinated care, which the Shared
Savings Program is intended to promote.
• Interprofessional Consultation (IPC)
(CPT codes 99446, 99447, 99448, 99449,
99451, 99452): In the CY 2019 PFS final
rule (83 FR 59489), CMS finalized six
codes:
++ 99446 (Interprofessional
telephone/internet assessment and
management service provided by a
consultative physician including a
verbal and written report to the patient’s
treating/requesting physician or other
qualified health care professional; 5–10
minutes of medical consultative
discussion and review);
++ 99447 (Interprofessional
telephone/internet assessment and
management service provided by a
consultative physician including a
verbal and written report to the patient’s
treating/requesting physician or other
qualified health care professional; 11–
20 minutes of medical consultative
discussion and review);
++ 99448 (Interprofessional
telephone/internet assessment and
management service provided by a
consultative physician including a
verbal and written report to the patient’s
treating/requesting physician or other
qualified health care professional; 21–
30 minutes of medical consultative
discussion and review);
++ 99449 (Interprofessional
telephone/internet assessment and
management service provided by a
consultative physician including a
verbal and written report to the patient’s
treating/requesting physician or other
qualified health care professional; 31
minutes or more of medical consultative
discussion and review);
++ 99451 (Interprofessional
telephone/internet/electronic health
record assessment and management
service provided by a consultative
physician including a written report to
the patient’s treating/requesting
physician or other qualified health care
professional, 5 or more minutes of
medical consultative time); and
++ 99452 (Interprofessional
telephone/internet/electronic health
record referral service(s) provided by a
treating/requesting physician or
qualified health care professional, 30
minutes).
These CPT codes describe assessment
and management services conducted
through telephone, internet, or
electronic health record consultations
furnished when a patient’s treating
physician or other qualified healthcare
professional requests the opinion and/or
treatment advice of a consulting
physician or qualified healthcare
professional with specific specialty
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expertise to assist with the diagnosis
and/or management of the patient’s
problem without the need for the
patient’s face-to-face, in-person contact
with the consulting physician or
qualified healthcare professional. We
believe that payment for these
interprofessional consultations
performed via communications
technology such as telephone or internet
is consistent with our ongoing efforts to
recognize and reflect medical practice
trends in primary care and patientcentered care management within the
PFS. Accordingly, because these CPT
codes 99446, 99447, 99448, 99449,
99451, and 99452 recognize and reflect
medical practice trends in primary care
and patient-centered care, we believe
they should be included in the
definition of primary care services used
for purposes of assignment.
Beginning in the CY 2012 PFS
proposed rule (76 FR 42793), we
recognized the changing focus in
medical practice toward managing
patients’ chronic conditions, many of
which particularly challenge the
Medicare population, including heart
disease, diabetes, respiratory disease,
breast cancer, allergies, Alzheimer’s
disease, and factors associated with
obesity. Current E/M coding does not
adequately reflect the changes that have
occurred in medical practice, and the
activities and resource costs associated
with the treatment of these complex
patients in the primary care setting In
the years since 2012, we have
acknowledged the shift in medical
practice away from an episodic
treatment-based approach to one that
involves comprehensive patientcentered care management, and have
taken steps through rulemaking to better
reflect that approach in payment under
the PFS. In the CY 2013 PFS final rule
(77 FR 68979), we established new
codes to pay separately for TCM
services. Next, in the CY 2015 PFS final
rule (79 FR 67715), we finalized new
coding and separate payment beginning
in CY 2015 for CCM services provided
by clinical staff. In the CY 2017 PFS
final rule (81 FR 80225), we established
separate payment for complex CCM
services, an add-on code to the visit
during which CCM is initiated to reflect
the work of the billing practitioner in
assessing the beneficiary and
establishing the CCM care plan and
established separate payment for
Behavioral Health Integration (BHI)
services (81 FR 80226 through 80227).
As part of this shift in medical practice,
and with the proliferation of team-based
approaches to care that are often
facilitated by electronic medical record
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technology, we believe that making
separate payment for interprofessional
consultations undertaken for the benefit
of treating a patient would contribute to
payment accuracy for primary care and
care management services. Refer to the
CY 2019 PFS Final rule (83 FR 59489)
for detailed, technical discussion
regarding the description, payment and
utilization of these CPT codes.
Since the services associated with
CPT codes 99446, 99447, 99448, 99449,
99451, and 99452 include TCM, CCM,
and BHI services, which are included in
our definition of primary care services
and are included in the proposed APCM
bundle that we propose to be included
in the definition of primary care
services used for purposes of
assignment, we believe that the services
associated with CPT codes 99446,
99447, 99448, 99449, 99451, and 99452
should be included in the definition of
primary care services for purposes of
assignment. We additionally believe the
services billed under this code reflect
the types of services we expect primary
care providers to provide in order to
improve care coordination and care
management. These IPC services were
also designed to reimburse for
comprehensive patient-centered care
management and primary care, which
the Shared Savings Program is intended
to promote.
• Direct Care Caregiver Training
Services (HCPCS codes GCTD1, GCTD2,
and GCTD3): GCTD1 (Caregiver training
in direct care strategies and techniques
to support care for patients with an
ongoing condition or illness and to
reduce complications (including, but
not limited to, techniques to prevent
decubitus ulcer formation, wound
dressing changes, and infection control)
(without the patient present), face-toface; initial 30 minutes)), GCTD2
(Caregiver training in direct care
strategies and techniques to support
care for patients with an ongoing
condition or illness and to reduce
complications (including, but not
limited to, techniques to prevent
decubitus ulcer formation, wound
dressing changes, and infection control)
(without the patient present), face-toface; each additional 15 minutes (List
separately in addition to code for
primary service) (Use GCTD2 in
conjunction with GCTD1)), and GCTD3
(Group caregiver training in direct care
strategies and techniques to support
care for patients with an ongoing
condition or illness and to reduce
complications including, but not limited
to, techniques to prevent decubitus ulcer
formation, wound dressing changes, and
infection control) (without the patient
present), face-to-face with multiple sets
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of caregivers). In section II.E. of this
proposed rule, we are proposing to
establish new coding and payment for
caregiver training services (CTS) for
direct care services and supports. The
topics of training could include, but
would not be limited to, techniques to
prevent decubitus ulcer formation,
wound dressing changes, and infection
control. Refer to section II.E. of this
proposed rule for detailed, technical
discussion regarding the proposed
description, payment, and utilization of
this HCPCS code.
Unlike other caregiver training codes
that are currently paid under the PFS,
the caregiver training codes for direct
care services and support focus on
specific clinical skills aimed at the
caregiver effectuating hands-on
treatment, reducing complications, and
monitoring the patient. Like other codes
describing caregiver training services,
these proposed new codes would reflect
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. 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 is established. The CTS
themselves need to be congruent with
the treatment plan and designed to
effectuate the desired patient outcomes.
Direct care training for caregivers of
Medicare beneficiaries 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. We believe that
since CTS may be integral to a patient’s
overall treatment and furnished after the
treatment plan is established, these
services should be included in the
definition of primary care services for
purposes of beneficiary assignment in
support of the Shared Savings Program’s
goal to promote coordinated, high
quality care to an ACO’s assigned
beneficiaries. In the CY 2024 PFS final
rule (88 FR 79168 through 79169), we
finalized the inclusion of other caregiver
training services (CPT codes 96202,
96203, 97550, 97551, and 97552) in the
definition of primary care services used
for purposes of assignment in the
Shared Savings Program. These new
caregiver training services codes
(HCPCS GCTD1, GCTD2, and GCTD3)
are similar to the caregiver training
services currently included in the
Shared Savings Program definition of
primary care services in that these codes
allow treating practitioners to report the
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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. We also believe
the services billed under these codes
reflect the types of services we expect
primary care providers to provide in
order to improve care coordination and
care management.
• Individual Behavior Management/
Modification Caregiver Training
Services (HCPCS codes GCTB1 and
GCTB2): GCTB1 (Caregiver training in
behavior management/modification for
caregiver(s) of a patient with a mental
or physical health diagnosis,
administered by physician or other
qualified health care professional
(without the patient present), face-toface; initial 30 minutes) and GCTB2
(Caregiver training in behavior
management/modification for
caregiver(s) of a patient with a mental
or physical health diagnosis,
administered by physician or other
qualified health care professional
(without the patient present), face-toface; each additional 15 minutes (List
separately in addition to code for
primary service) (Use GCTB2 in
conjunction with GCTB1)). In section
II.E of this proposed rule, we are
proposing to establish new coding and
payment for caregiver behavior
management and modification training
that could be furnished to the
caregiver(s) of an individual patient.
Behavior management/modification
training for caregivers of Medicare
beneficiaries 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 training activity should be clearly
identified and documented in the
treatment plan. All other policies and
procedures surrounding CPT 96202 and
96203 will also apply to these services
(88 FR 78914–78920). Refer to section
II.E. of this proposed rule for detailed,
technical discussion regarding the
proposed description, payment and
utilization of this HCPCS code.
We believe that, since CTS may be
reasonable and necessary when they are
integral to a patient’s overall treatment
and furnished after the treatment plan is
established especially in the case of
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), these services should be
included in the definition of primary
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care services for purposes of beneficiary
assignment in support of the Shared
Savings Program’s goal to promote
coordinated, high quality care to an
ACO’s assigned beneficiaries. In the CY
2024 PFS final rule (88 FR 79168
through 79169), we finalized the
inclusion of other caregiver training
services (CPT codes 96202, 96203,
97550, 97551, and 97552) in the
definition of primary care services used
for purposes of assignment in the
Shared Savings Program. These new
caregiver training services codes
(HCPCS codes GCTD1, GCTD2, GCTD3,
GCTB1, and GCTB2) are similar to the
caregiver training services currently
included in the Shared Savings Program
definition of primary care services in
that 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, which is integral to care
coordination. We also believe the
services billed under these codes reflect
the types of services we expect primary
care providers to provide in order to
improve care coordination and care
management.
As part of this revised definition of
primary care services used for assigning
beneficiaries under § 425.402, we
propose to incorporate a provision in
§ 425.400(c)(1)(ix)(C), specifying that the
primary care service codes for purposes
of assigning beneficiaries include a CPT
code identified by CMS that directly
replaces a CPT code specified in
§ 425.400(c)(1)(ix)(A) or a HCPCS code
specified in § 425.400(c)(1)(ix)(B), when
the assignment window or expanded
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.
We seek comment on these proposed
changes to the definition of primary care
services used for assigning beneficiaries
under § 425.400(c)(1)(ix) to Shared
Savings Program ACOs for the
performance year starting on January 1,
2025, 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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b. Proposed Revisions to Criteria for
ACO Models To Waive Shared Savings
Program Statutory Requirements Giving
Precedence for Assignment Based on
Beneficiary Voluntary Alignment
(1) Background
Section 50331 of the Bipartisan
Budget Act of 2018 amended section
1899(c) of the Act to add a new
paragraph (2)(B) that requires the
Secretary, for performance year 2018
and each subsequent performance year,
to permit a Medicare FFS beneficiary to
voluntarily identify an ACO
professional as the primary care
provider of the beneficiary for purposes
of assigning such beneficiary to an ACO.
A voluntary identification by a
Medicare FFS beneficiary under this
provision supersedes any claims-based
assignment. In earlier rulemaking (81 FR
80501 through 80510 and 83 FR 59959
through 59964) CMS finalized
modifications to the Shared Savings
Program regulations at § 425.402(e) to
implement the statutory requirements
governing voluntary alignment.
In the November 2018 final rule (83
FR 59959 through 59964), we finalized
changes to the beneficiary voluntary
alignment policies (refer to § 425.402(e))
to revise the requirements previously
established for the voluntary alignment
process. We explained that it could be
appropriate, in limited circumstances,
to align a beneficiary to an entity
participating in certain specialty and
disease-specific CMS Innovation Center
models to test a new system of payment
and service delivery that CMS believes
would lead to better health outcomes for
Medicare beneficiaries while lowering
costs to Medicare Parts A and B.
Additionally, we explained that it could
be difficult for the CMS Innovation
Center to conduct a viable test of a
specialty or disease-specific model, if
we were to require that beneficiaries
who have previously designated an
ACO professional as their primary
clinician remain assigned to the Shared
Savings Program ACO under all
circumstances. We applied this
exception for the Comprehensive ESRD
Care (CEC) model, which assigned
beneficiaries to entities participating in
the model through the beneficiaries’
first treatment at a participating dialysis
facility.
Currently, under § 425.402(e)(2)(ii)(D),
we would not assign a beneficiary who
has voluntarily identified a Shared
Savings Program ACO professional to a
Shared Savings Program ACO when the
beneficiary is also eligible for claimsbased assignment to an entity
participating in a model tested or
expanded under section 1115A of the
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Act under which claims-based
assignment is based solely on claims for
services other than primary care
services and for which there has been a
determination by the Secretary that a
waiver under section 1115A(d)(1) of the
Act of the requirement in section
1899(c)(2)(B) of the Act is necessary
solely for purposes of testing the model.
(2) Proposed Revisions
Since finalization of this limited
exception to the Shared Savings
Program’s voluntary alignment policy,
disease-specific CMS Innovation Center
models have been developed that use
claims for both primary care services
and services other than primary care in
determining claims-based assignment to
entities participating in these models.
We believe it would be appropriate to
propose to broaden this limited
exception and allow a voluntarily
aligned Shared Savings Program
beneficiary to be claims-based assigned
to an entity participating in a disease- or
condition-specific CMS Innovation
Center model when that model uses
claims-based assignment that is based
on primary care and/or other services.
Disease- or condition-specific CMS
Innovation Center models are designed
to support condition management,
coordination, and services for patients
that have a specific disease or condition
that often requires coordination of care
across specialties and settings. For
example, the CMS Innovation Center
has tested disease- and condition-based
episode payment models, such as those
focused on oncology and kidney
disease.464 Doing so would help
beneficiaries with certain diseases or
conditions benefit from the focused
attention and care coordination related
to the disease or condition that an entity
participating in such a model could
provide. We would identify models for
which the exception would apply in our
Shared Savings and Losses and
Assignment Methodology and Quality
Performance Specifications document,
which is located on the Shared Savings
Program website, https://www.cms.gov/
medicare/payment/fee-for-serviceproviders/shared-savings-program-sspacos. This proposed expanded
exception would be applicable to
beneficiaries assigned to entities
participating in CMS Innovation Center
models under which assignment is
based solely on (1) claims for primary
care and/or other services related to
treatment of one or more specific
464 Refer to Innovation Models website: https://
www.cms.gov/priorities/innovation/
models#views=models&cat=diseasespecific%20&%20episode-based%20models.
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diseases or conditions targeted by the
model, or (2) claims for services other
than primary care services, when the
Secretary has determined that a waiver
is necessary solely for purposes of
testing the model.
An example of a CMS Innovation
Center model whose assigned
beneficiaries may be impacted by the
proposed expanded exception is the
Kidney Care Choices (KCC) model,465
which is designed to help health care
providers reduce the cost and improve
the quality of care for patients with latestage chronic kidney disease and ESRD.
The KCC model builds on the previous
CEC model 466 by adding strong
financial incentives for health care
providers to manage the care for
Medicare beneficiaries with chronic
kidney disease (CKD) stage 4 and ESRD,
to delay the onset of dialysis and to
incentivize kidney transplantation.
Under the CEC model, the CMS
Innovation Center worked with groups
of health care providers, dialysis
facilities, and other suppliers involved
in the care of ESRD beneficiaries to
improve the coordination and quality of
care that these individuals received. We
determined that an ESRD beneficiary,
who was otherwise eligible for
assignment to an entity participating in
the CEC model, could benefit from the
focused attention on and increased care
coordination for their ESRD available
under the CEC model. As described
above, we created a narrow exception to
the general policy that a beneficiary
who had voluntarily aligned to a Shared
Savings Program ACO professional
would supersede their alignment to a
CMS Innovation Center model.
Specifically, we did not assign a
beneficiary to the ACO when the
beneficiary was also eligible for
alignment to an entity participating in
the CEC model.
KCC is more complex than CEC and
is designed to capture multiple care
relationships and uses a mix of E/M
codes for alignment of beneficiaries
with CKD and managing clinician
Monthly Capitation Payments for
aligning ESRD beneficiaries. The
existing exception is not applicable to
KCC in part because claims for primary
care and other services related to the
treatment of one or more specific
diseases or conditions targeted by the
model (chronic kidney disease (CKD)
stage 4 and ESRD) are considered as part
of the model’s beneficiary alignment
465 Refer to https://www.cms.gov/priorities/
innovation/innovation-models/kidney-care-choiceskcc-model.
466 Refer to https://www.cms.gov/priorities/
innovation/innovation-models/comprehensive-esrdcare.
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methodology, which takes into
consideration where a beneficiary
receives the majority of their kidney
care as well as the beneficiary’s
diagnosis of CKD stages 4 or ESRD
receiving maintenance dialysis. KCC’s
alignment methodology could align
beneficiaries receiving primary care
services that are also considered for
Shared Savings Program assignment if
furnished and billed under one of the
HCPCS/CPT codes included in
§ 425.400(c) by ACO professionals who
are primary care physicians, physicians
with one of the primary specialty
designations in § 425.402(c), NPs, PAs,
and/or CNSs. We note that outpatient/
office E/M services are included in
§ 425.400(c) and that nephrology is one
of the primary specialty designations
under § 425.402(c) so we anticipate that,
if this proposal is finalized, most, if not
all, beneficiaries who voluntarily align
to a physician that participates in a
Shared Savings Program ACO and meet
the KCC alignment criteria would be
claims-based align to the KCC model,
assuming there is a determination by the
Secretary that waiver of the requirement
in section 1899(c)(2)(B) of the Act is
necessary solely for purposes of testing
the model.
We propose expanding upon current
Shared Savings Program regulations to
broaden the existing exception to the
program’s voluntary alignment policy,
which would allow the exception to
apply to beneficiaries assigned to
entities in a CMS Innovation Center
model under which claims-based
assignment is based solely on (1) claims
for primary care and/or other services
related to treatment of one or more
specific diseases or conditions targeted
by the model, or (2) claims for services
other than primary care services, and for
which there has been a determination
by the Secretary that waiver of the
requirement in section 1899(c)(2)(B) of
the Act is necessary for purposes of
testing the model. Under the proposed
revisions, if a beneficiary voluntarily
aligns to a Shared Savings Program ACO
under § 425.402(e), we would not assign
the beneficiary to that Shared Savings
Program ACO when the beneficiary is
also eligible for claims-based
assignment to an entity participating in
a model tested or expanded under
section 1115A of the Act under which
claims-based assignment is based solely
on (1) claims for primary care and/or
other services related to treatment of
one or more specific diseases or
conditions targeted by the model or (2)
claims for services other than primary
care service, and for which there has
been a determination by the Secretary
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that waiver of the requirement in
section 1899(c)(2)(B) of the Act is
necessary for purposes of testing the
model. We would not supersede
voluntary alignment for CMS Innovation
Center models that are not designed to
target a specific disease or condition,
such as ACO REACH. While ACO
REACH contains design features for
organizations serving high needs
beneficiaries, it is designed more
broadly, and not for beneficiaries with
a specific disease or condition. Such
models do not target a specific disease
or condition. Therefore, a beneficiary’s
claims-based assignment to an entity
participating in such a model would not
supersede their voluntary alignment to
a Shared Savings Program ACO under
our proposal.
For example, under the KCC model,
alignment is based on where a
beneficiary receives the majority of their
nephrology services and/or dialysis
management services. Claims for those
kidney care services could include
claims for services that, under the
Shared Savings Program’s claims-based
assignment policies, would lead a
beneficiary to be assigned to a Shared
Savings Program ACO. Since under the
KCC model, claims-based assignment is
based solely on claims for primary care
and/or other services (kidney care
services) related to the treatment of one
or more specific diseases or conditions
targeted by the model (chronic kidney
disease (CKD) stage 4 and ESRD), our
proposed exception would apply and a
beneficiary who voluntarily aligned to a
Shared Savings Program ACO and who
received kidney care services from an
entity participating in the KCC model
would nonetheless be claims-based
assigned to the KCC model, if there is
a determination by the Secretary that
waiver of the requirement in section
1899(c)(2)(B) of the Act is necessary
solely for purposes of testing the KCC
model. This proposed expansion of the
voluntary alignment exception would
support assignment of beneficiaries to
entities participating in CMS Innovation
Center models, which would reduce
barriers for the CMS Innovation Center
to conduct viable tests of disease-or
condition-specific models and thereby
improve access to high-quality, valuebased specialty care, such as that
provided by an entity participating in a
model focused on diabetes care or care
provided by specific specialists, such as
cardiologists or gastroenterologists.
This proposal would also support
CMS’s goals of improving patient care,
lowering costs, and better aligning
payment systems to promote patientcentered practices through accountable
and value-based care. We believe that
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specific subpopulations of Medicare
beneficiaries who are otherwise eligible
for assignment to an entity participating
in a disease or condition-specific CMS
Innovation Center model, but who may
not be captured by § 425.402(e)(2)(ii)(D)
because their models consider primary
care services for purposes of
assignment, could benefit from the
focused attention and increased care
coordination offered by an entity
participating in a disease or conditionspecific model. Application of this
exception would require a
determination from the Secretary to
waive the voluntary alignment
provision.
Under this proposal, if a beneficiary
designated an ACO professional
participating in a Shared Savings
Program ACO as the physician or
practitioner they consider responsible
for coordinating their overall care (that
is, their primary clinician), but the
beneficiary is also eligible for
assignment to an entity participating in
a model tested or expanded under
section 1115A of the Act under which
claims-based assignment is based solely
on (1) claims for primary care and/or
other services related to treatment of
one or more specific diseases or
conditions targeted by the model, or (2)
claims for services other than primary
care services, and for which there has
been a determination that a waiver of
the requirement in section 1899(c)(2)(B)
of the Act is necessary solely for
purposes of testing the model, the CMS
Innovation Center or its designee would
notify the beneficiary of their
assignment to an entity participating in
the model. Additionally, although such
a beneficiary may still voluntarily
identify an ACO professional
participating in a Shared Savings
Program ACO as their primary clinician
and seek care from any clinician, the
beneficiary would not be assigned to a
Shared Savings Program ACO even if
the designated primary clinician is an
ACO professional in a Shared Savings
Program ACO.
For PY 2024, there are approximately
152,000 beneficiaries with a primary
clinician selection who is a Shared
Savings Program ACO professional as
defined at § 425.20, and approximately
83,000 are voluntarily aligned to a
Shared Savings Program ACO after
meeting all the assignment eligibility
criteria as described at § 425.401(a).
Overall, this represents an exceedingly
small share of the overall Shared
Savings Program assigned beneficiary
population, currently 10.8 million 467
467 Refer to https://www.cms.gov/files/document/
2024-shared-savings-program-fast-facts.pdf.
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beneficiaries. Additionally, simulating
our proposed § 425.402(e)(2)(ii)(D) using
PY 2024 data, less than 1 percent (703)
of beneficiaries who are voluntarily
aligned to a Shared Savings Program
ACO would instead be claims-based
assigned to an entity participating in a
CMS Innovation Center model.
The benefit of allowing beneficiaries
who voluntarily align to a Shared
Savings Program ACO to be claimsbased assigned to an entity participating
in a CMS Innovation Center tailored to
the needs of their specific disease or
condition far outweighs any cost to the
Shared Savings Program. The impact of
assigning these beneficiaries to a CMS
Innovation Center model
notwithstanding their voluntary
designation would be minimal because
so few beneficiaries would be impacted
by this proposed expansion of the
exception (for PY 2024, less than 1
percent of all beneficiaries who
voluntarily align to a Shared Savings
Program ACO). As explained earlier in
this section, this proposal would enable
us to better test CMS Innovation Center
models and ultimately improve health
outcomes for Medicare beneficiaries
with the specific diseases and
conditions targeted by CMS Innovation
Center models. We also recognize the
importance of continuing to allow
beneficiaries to voluntarily identify an
ACO professional as their primary
clinician for purposes of assignment to
a Shared Savings Program ACO, and we
reiterate that, based on PY 2024 data,
this proposal would impact very few
beneficiaries who voluntarily align to
Shared Savings Program ACOs (less
than .01 percent of all such
beneficiaries). Beneficiaries who
voluntarily align to a Shared Savings
Program ACO but are, pursuant to our
proposal, ultimately claims-based
assigned to an entity participating in a
CMS Innovation Center model would be
notified of this in accordance with the
CMS Innovation Center model’s
participation agreement. We propose to
apply these modifications to our
policies under the Shared Savings
Program regarding voluntary alignment
beginning for performance year 2025,
and subsequent performance years. We
propose to incorporate these new
requirements into new regulations at
§ 425.402(e)(2)(iii). We solicit comments
on this proposal.
Accordingly, since the new proposed
provisions § 425.402(e)(2)(iii) will
supersede the existing provisions at
§ 425.402(e)(2)(ii) for performance year
2025 and subsequent performance years,
we propose to revise the introductory
text at § 425.402(e)(2)(ii) to designate
that provision’s applicability for
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performance years starting on January 1,
2019, through 2024.
4. Quality Performance Standard &
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 and wherever
practicable, caregiver 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, 2023,
and 2024 PFS final rules (79 FR 67907
through 67921, 80 FR 71263 through
71268, 81 FR 80484 through 80489, 83
FR 59708 through 59715, 87 FR 69860
through 69863, and 88 FR 79112
through 79114, respectively).
b. Proposal to Require Shared Savings
Program ACOs to Report the Alternative
Payment Model (APM) Performance
Pathway (APP) Plus Quality Measure
Set
(1) Background
In the CY 2021 PFS final rule, we
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 through 84743). For performance
year 2021 and subsequent years, ACOs
are required to report quality data via
the APP codified at § 414.1367.
Pursuant to policies 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 electronic clinical quality
measures (eCQMs)/Merit-based
Incentive Payment System (MIPS)
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61853
clinical quality measures (CQMs), and
administer the Consumer Assessment of
Healthcare Providers and Systems
(CAHPS) for MIPS survey. In
performance year 2025 and subsequent
performance years, ACOs must report
the three eCQMs/MIPS CQMs and
administer the CAHPS for MIPS survey.
In the CY 2024 PFS final rule, we
established the Medicare Clinical
Quality Measures 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 within
the APP quality measure set for
performance year 2024 and subsequent
performance years (88 FR 79107).
Shared Savings Program ACOs have the
option to report on Medicare CQMs,
which are reported on an ACO’s eligible
Medicare fee-for-service beneficiaries,
instead of the ACO’s all payer/all
patient population. Medicare CQMs are
aligned with MIPS standards for data
completeness, measure benchmarking,
and scoring (88 FR 79099 and 88 FR
79108). In the CY 2024 PFS final rule,
we stated that 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 eCQMs/MIPS CQMs and
support ACOs in the transition to digital
quality measure reporting (88 FR 79097
through 79098).
Since the CY 2021 PFS final rule was
issued, ACOs and other interested
parties have continued to express
concerns about requiring ACOs to report
all payer/all patient eCQMs/MIPS CQMs
due to the cost of purchasing and
implementing a system wide
infrastructure to aggregate data from
multiple ACO participant taxpayer
identification numbers (TINs) and
varying electronic health record (EHR)
systems (86 FR 65257). In the CY 2022
PFS final rule, commenters supported
our acknowledgement of the complexity
of the transition to all payer/all patient
eCQMs/MIPS CQMs (86 FR 65259). In
public comments on 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).
ACOs face continued difficulties in
aggregating data on the three all payer/
all patient eCQMs/MIPS CQMs that are
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part of the existing APP quality measure
set. The Shared Savings Program
continues to receive feedback from
ACOs and other stakeholders about the
difficulties with reporting on the three
all payer/all patient eCQMs/MIPS CQMs
and meeting data management
requirements given their muti-practice/
multi EHR structure. Additionally, we
continue to receive feedback on the
challenges of aggregating data due to the
health information technology (IT)
infrastructure in use by ACOs and the
current state of interoperability.
Building on our goal to provide
technical support to ACOs and 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://youtu.be/
LDrpoGnnRQs. 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
%20Document%20for%20ACOs.pdf.
Over the past 2 years, we have learned
that there are complexities and hurdles
concerning ACOs adopting the all
payer/all patient collection types; as a
result, the widespread adoption of the
all payer/all patient collection types
require further time and support. For
example, our internal data indicate that
in performance year 2021, 12 out of 475
ACOs reported eCQMs/MIPS CQMs
under the APP, while 37 out of 482
ACOs reported eCQMs/MIPS CQMs in
performance year 2022.468 Submission
data for performance year 2023 indicate
that 73 out of 456 ACOs reported
eCQMs/MIPS CQMs under the APP.
Further, we have come to understand
that additional maturation processes are
needed to support large, complex
organizations like ACOs that participate
in the Shared Savings Program to fully
and equitably participate in the all
payer/all patient collection types.
CMS’ goal, as stated in the CY 2024
PFS final rule, is to support ACOs in the
adoption of all payer/all patient
468 Counts based on internal analysis of ACOs’
quality reporting in performance years 2021 and
2022.
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measures (88 FR 79098). In that rule, we
described our intention to monitor the
reporting of quality data utilizing the
Medicare CQM collection type, which
would include assessing if any Medicare
CQMs qualify as topped out as
described at § 414.1380(b)(1)(iv) (88 FR
79098). We also noted that,
‘‘[s]eparately, 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’’ (88 FR
79098).
Under the goals of the CMS National
Quality Strategy to improve the quality
and safety of healthcare for everyone,
CMS is implementing a building-block
approach and aligning the measures
used to establish the Shared Savings
Program quality performance standard
with the Universal Foundation of
quality measures and streamlining
quality measures across CMS quality
programs for measuring primary care
clinician performance in the adult and
pediatric populations.469 In the CY 2024
PFS proposed rule, we stated that ‘‘we
intend to propose future policies
aligning the APP measure set for Shared
Savings Program ACOs with the quality
measures under the ‘Universal
Foundation’ beginning in performance
year 2025’’ (88 FR 52423). A few
commenters were supportive of aligning
the APP quality measure set with the
Universal Foundation measures, while
other commenters were opposed.
Several commenters urged CMS to first
test measures before making them
required and scored measures for ACOs.
Commenters were concerned about
balancing the alignment of the Universal
Foundation measures with efforts to
reduce administrative burden, potential
growth in the number of measures ACOs
would have to report, and implementing
multiple major changes to the APP
quality measure set in performance year
2025. In the CY 2024 PFS final rule, we
stated that we will take the comments
under consideration in future
rulemaking, as we evaluate the impact
of aligning the APP quality measure set
with the Universal Foundation
measures (88 FR 79114).
469 Centers for Medicare & Medicaid Services
(2024). CMS National Quality Strategy. Accessed
June 24, 2024. https://www.cms.gov/medicare/
quality/meaningful-measures-initiative/cmsquality-strategy.
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(2) Proposed Revisions
(a) Proposal To Require Shared Savings
Program ACOs To Report the APP Plus
Quality Measure Set
To further advance Medicare’s overall
value-based care strategy and maintain
alignment within and across CMS’
quality programs, in section IV.A.4.c.(2)
of this proposed rule, we are proposing
to create the APP Plus quality measure
set to align with the Adult Universal
Foundation measures. Out of the ten
Adult Universal Foundation measures,
five of the measures are already in the
APP quality measure set for
performance year 2025 under policies
finalized in the CY 2024 PFS final rule
(88 FR 79112 through 79113). There is
one measure—Clinician and Clinician
Group Risk-standardized Hospital
Admission Rates for Patients with
Multiple Chronic Conditions (Measure #
484)—in the APP quality measure set
that is not an Adult Universal
Foundation measure, resulting in a total
of six measures that are in the APP
quality measure set.
Under the proposed approach, the
APP Plus quality measure set would
incrementally grow to comprise of
eleven measures, consisting of the six
measures in the existing APP quality
measure set and five newly proposed
measures from the Adult Universal
Foundation measure set that would be
incrementally incorporated into the APP
Plus quality measure set over
performance years 2025 through 2028.
The proposed new measures and the
timeline for incorporating the measures
into the APP Plus quality measure set
are described in section IV.A.4.c.(3) of
this proposed rule and below. The
proposal in section IV.A.4.c.(2) is to
make the APP Plus quality measure set
an optional measure set for APP
reporters. For performance year 2025
and subsequent performance years, we
are proposing to require Shared Savings
Program ACOs to report the APP Plus
quality measure set as proposed in
section III.G.4.b.(2)(a) of this proposed
rule. Consequently, the APP quality
measure set would no longer be
available for reporting by Shared
Savings Program ACOs beginning in
performance year 2025. Our proposal
would align the quality measures that
Shared Savings Program ACOs would be
required to report with the quality
measures under the Adult Universal
Foundation measure set incrementally
beginning in performance year 2025.
Creating alignment with the Adult
Universal Foundation would better
align the quality measures reported by
Shared Savings Program ACOs with the
Medicaid Core Sets and the Marketplace
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Quality Rating System, which have
previously adopted the quality measures
in the Universal Foundation.470 As
discussed in section IV.A.4.c.(2) of this
proposed rule, alignment of quality
measures across CMS programs allows
practitioners to better focus their quality
efforts, reduce administrative burden,
and drive digital transformation and
stratification of a focused quality
measure set to assess impact on
disparities.471 Our proposed alignment
with the Adult Universal Foundation
would also better align the quality
measures reported by Shared Savings
Program ACOs with the Value in
Primary Care MIPS Value Pathway
(MVP), which contains the same
Universal Foundation measures. This
may create a smoother transition for
clinicians from MIPS to the Shared
Savings Program. Alignment would
allow clinicians to leverage their
familiarity and experience with the
Adult Universal Foundation quality
measures among primary care clinicians
participating in this MVP as they
transition to reporting the APP Plus
quality measure set in the Shared
Savings Program. Experience and
familiarity with the same quality
measures, redesigned care processes,
and quality improvement activities that
are commonplace in ACOs would
streamline the pathway for clinicians to
join ACOs in the future and is
consistent with our goal to have all
beneficiaries in an accountable care
relationship by 2030.
Section 1899(b)(3)(C) of the Act
requires CMS to 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. In the
November 2011 final rule, we finalized
33 quality measures for use in
establishing the quality performance
standard measure set for ACOs:
including 22 measures that were
actively reported by ACOs via the Group
Practice Reporting Option (GPRO) Web
Interface (76 FR 67889). As we stated in
the November 2011 final rule
establishing the Shared Savings
Program, our principal goal in selecting
quality measures for ACOs has been to
identify measures of success in the
470 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, February 1, 2023,
available at https://www.nejm.org/doi/full/10.1056/
NEJMp2215539.
471 Jacobs D, et al., Update On The Medicare
Value-Based Care Strategy: Alignment, Growth,
Equity. Health Affairs Forefront (March 14, 2024),
available at https://www.healthaffairs.org/content/
forefront/update-medicare-value-based-carestrategy-alignment-growth-equity.
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delivery of high-quality health care at
the individual and population levels,
with a focus on outcomes (76 FR 67872).
As we sought to improve the quality of
care furnished by ACOs over time, we
have subsequently updated this measure
set through rulemaking in the CY 2015,
2016, 2017, 2019, and 2023 PFS final
rules (79 FR 67907 through 67921, 80
FR 71263 through 71268, 81 FR 80484
through 80489, 83 FR 59707 through
59715, and 87 FR 69860 through 69763,
respectively). We have also sometimes
increased the number of measures
reported by ACOs through rulemaking.
For example, in the CY 2016 PFS final
rule, we increased the Shared Savings
Program quality measure set from 33
total measures to 34 total measures (80
FR 71265). In the CY 2016 PFS final
rule, we noted that since the November
2011 Shared Savings Program final rule,
we have continued to review the quality
measures used for the Shared Savings
Program to ensure that they are up to
date with current clinical practice and
aligned with other CMS quality
reporting programs (80 FR 71264). Also,
through rulemaking, we sometimes
reduced the number of measures
reported by ACOs. For example, in the
CY 2019 PFS final rule, we finalized
policies which reduced the Shared
Savings Program quality performance
measure set to 23 measures in PY 2019
(83 FR 59715). In developing our
proposals in the CY 2019 PFS final rule,
we stated that we considered the
agency’s efforts to streamline quality
measures, reduce regulatory burden,
and promote innovation as part of
broader CMS initiatives (83 FR 59711).
In the CY 2021 PFS final rule, we again
reduced the total number of measures
that ACOs must report (85 FR 84733).
Specifically, through the adoption of the
APP quality measure set, we reduced
the total number of measures from 23 to
either 6 or 13 measures (depending on
the ACO’s chosen reporting option) for
PY 2021 (85 FR 84723).
Our proposal to adopt the APP Plus
quality measure set for ACOs that
participate in the Shared Savings
Program would increase the number of
measures reported by ACOs that
currently report the eCQM/MIPS CQM
measure set from three measures in
performance year 2024 to five measures
in performance year 2025. For ACOs
that reported the CMS Web Interface
measures, our proposal to adopt the
APP Plus quality measure set would
decrease the number of measures
reported from ten measures in
performance year 2024 to eight
measures in performance year 2025.
While we acknowledge that the increase
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61855
in the number of measures for ACOs
that currently report the eCQM/MIPS
CQM measure set may be an increased
burden for those ACOs, we are using a
phased-in approach to expand the APP
Plus quality measure set between
performance years 2025 and 2028,
which should help to minimize the
impact of increased burden associated
with reporting additional measures. The
option for ACOs to report Medicare
CQMs, which are MIPS CQMs that are
reported on an ACO’s fee-for-service
population, may also alleviate the
reporting burden for ACOs that report
Medicare CQMs by focusing an ACO’s
patient matching and data aggregation
efforts only on an ACO’s eligible
Medicare fee-for-service population.
Additionally, we believe that the
benefits of scoring an increased number
of measures may offset the increased
burden that some ACOs may face in
adopting the additional measures. For
example, as the number of measures in
the measure set increases, the
individual weight of each measure on
the ACO’s quality performance score
decreases. Each measure in a sixmeasure set would account for roughly
16.67 percent of an ACO’s MIPS Quality
performance category score while each
measure in an eight-measure set would
account for 12.5 percent of an ACO’s
MIPS Quality performance category
score. The scoring of more measures, in
concert with the scoring policies
proposed in sections IV.A.4.f.(1)(b)(iii)
and IV.A.4.f.(1)(c)(i) of this proposed
rule, may result in improved quality
performance scores for the ACOs as
each individual measure carries less
weight.
The proposed APP Plus quality
measure sets for Shared Savings
Program ACOs for performance year
2025, performance years 2026 and 2027,
and performance year 2028 and
subsequent performance years are
displayed in Tables 34, 35, and 36,
respectively. Under our proposal, there
would be eight measures (five eCQMs/
Medicare CQMs, two administrative
claims measures, and the CAHPS for
MIPS Survey measure) in the APP Plus
quality measure set for Shared Savings
Program ACOs in performance year
2025 (Table 34), nine measures (six
eCQMs/Medicare CQMs, two
administrative claims measures, and the
CAHPS for MIPS Survey measure) in
performance years 2026 and 2027 (Table
35), and eleven measures (eight eCQMs/
Medicare CQMs, two administrative
claims measures, and the CAHPS for
MIPS Survey measure) in performance
years 2028 and subsequent performance
years (Table 36). We intend to update
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the APP Plus quality measure set as new
measures are added to or removed from
the Adult Universal Foundation
measure set in the future.
(b) Proposed Collection Types Available
for Shared Savings Program ACOs
Reporting the APP Plus Quality Measure
Set
We are proposing to streamline the
collection types available for Shared
Savings Program ACOs reporting the
APP Plus quality measure set to the
eCQM and Medicare CQM collection
types for performance year 2025 and
subsequent performance years. We
believe that our proposal to establish the
APP Plus quality measure set to align
with the Adult Universal Foundation
measure set should also aim to prioritize
the eCQM collection type—the gold
standard collection type that underlies
the Digital Quality Measurement (dQM)
Strategic Roadmap (available at https://
ecqi.healthit.gov/sites/default/files/
CMSdQMStrategicRoadmap_
032822.pdf)—and use Medicare CQMs
as the transition step on our buildingblock approach for ACOs’ progress to
adopt digital quality measurement. We
are also seeking to reduce reporting
burden on ACOs by using a phased-in
approach to expand the APP Plus
quality measure set between
performance years 2025 and 2028. We
will also continue to provide the
Medicare CQM reporting option as
ACOs increase their experience and
overcome their challenges with
reporting all payer/all patient measures.
As discussed more fully below, we are
proposing not to include the MIPS CQM
collection type for Shared Savings
Program ACOs reporting the APP Plus
quality measure set to focus ACOs’
efforts on the implementation of the
APP Plus quality measure set, while
continuing to encourage the adoption of
eCQMs. We believe that our proposed
approach would recognize the
investments ACOs have made to report
eCQMs and their benefits (that is, more
efficient data collection, real time
provider feedback, and less burden
through the use of digital data) and
allow ACOs that have invested in
eCQMs to continue on that track and
align with long term goals of digital
quality measurement.472
Since Medicare CQMs are MIPS
CQMs that are reported on an ACO’s
eligible Medicare fee-for-service
population, ACOs that have invested in
the infrastructure to report MIPS CQMs
472 Centers for Medicare & Medicaid Services
(2023). Electronic Clinical Quality Measure Basics
(eCQM 101). Accessed June 24, 2024. https://
ecqi.healthit.gov/sites/default/files/eCQM-Basics508.pdf.
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would be able to report Medicare CQMs
on a subset of their all payer/all patient
population. Furthermore, as noted in
the CY 2024 PFS final rule, Medicare
CQMs address ACO concerns related to
the difficulty of matching and
aggregating patient data across multiple
EHR systems (88 FR 79106). Medicare
CQMs also provide a transition path and
alternative for ACOs that have difficulty
reporting patient data by limiting the
beneficiaries for which an ACO must
match and aggregate data to only the
ACO’s eligible Medicare fee-for-service
beneficiaries, instead of their all payer/
all patient population (88 FR 79106). As
a logical next step in the reporting of
digital quality measures, this population
is larger than the sample currently used
in the CMS Web Interface, but not as
large as the all payer/all patient
population that must be reported for an
eCQM or MIPS CQM (88 FR 79106).
We aim to fully transition to digital
quality measurement in CMS quality
reporting and value-based purchasing
programs, and we are working to
convert current eCQMs to the Fast
Healthcare Interoperability Resources
(FHIR) standard (86 FR 65379).
Including eCQMs as a collection type
for Shared Savings Program ACOs
reporting the APP Plus quality measure
set aligns with our goal to transition to
digital quality measurement including
the alignment and development of FHIR
standards and tools for eCQM reporting
in the dQM Strategic Roadmap. There
are numerous benefits to using eCQMs,
including their use of electronic
standards that reduce the burden of
manual extraction and reporting for
measured entities, their use of clinical
data to assess the outcomes of treatment
by measured entities, and their fostering
of access to real-time data for point of
care quality improvement and decision
support.473 Furthermore, eCQMs align
with the Meaningful Measures
Framework 2.0 goal of improving
quality reporting efficiency by
transitioning to digital quality
measures.474 A recent study noted the
resource intensity of quality reporting,
underscoring the high cost of claimsbased measures relative to others and
recommended that policy makers shift
to electronic metrics to ‘‘optimize
resources spent in the overall pursuit of
higher quality.’’ 475 For these reasons,
473 eCQI Resource Center (2024). Get Started with
eCQMs. https://ecqi.healthit.gov/ecqms.
474 Centers for Medicare & Medicaid Services
(2024). Meaningful Measures 2.0: Moving to
Measure Prioritization and Modernization. https://
www.cms.gov/medicare/quality/meaningfulmeasures-initiative/meaningful-measures-20.
475 Saraswathula, A., et al., The Volume and Cost
of Quality Metric Reporting. JAMA (June 6, 2023),
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and to continue encouraging ACOs on
their progress to adopt digital quality
measurement, we are not modifying the
availability of eCQMs as a collection
type for ACOs that reported the APP
quality measure set by including eCQMs
as a collection type in the APP Plus
quality measure set in performance year
2025 and subsequent performance years.
In section III.G.7.e. of this proposed
rule, we seek comment on a higher risk,
higher reward track for Shared Savings
Program ACOs participating in the
ENHANCED track. In this request for
information, we seek comment on
questions relevant to our long-term
goals of supporting ACOs in their
transition to reporting all payer/all
patient quality measures: How should a
revised ENHANCED track with higher
risk and potential reward also require
additional accountability for quality?
Should ACOs in this revised track be
required to report all payer/all patient
quality measures?
In the CY 2024 PFS final rule, we
stated that ‘‘Medicare CQMs are
intended to serve as a transition to all
payer/all patient reporting and not as a
permanent collection type. We
acknowledge that ACOs are at different
stages of readiness to adopt all payer/all
patient measures, and we intend for
Medicare CQMs to be available to ACOs
during their transition to all payer/all
patient reporting.’’ (88 FR 79106). In the
CY 2024 PFS final rule, we also stated
that ‘‘[w]e expect that the sunsetting of
the Medicare CQM collection type may
be paced with the uptake of FHIR
Application Programming Interface
(API) technology, but this will be
assessed on industry readiness and CMS
requirements’’ (88 FR 79106).
Specifically, we anticipate that the
increased use of FHIR API technology
will facilitate ACOs’ reporting of eCQMs
and thus increase their uptake of them.
Future advancements in FHIR API
technology and its uptake among Shared
Savings Program ACOs may accelerate
our future plans to sunset Medicare
CQMs. As discussed earlier in this
section, we are proposing to streamline
the collection types available for Shared
Savings Program ACOs reporting the
APP Plus quality measure set to the
eCQM and Medicare CQM collection
types for performance year 2025 and
subsequent performance years and use
Medicare CQMs as the transition step on
our building-block approach for ACOs’
progress to adopt digital quality
measurement. As we continue to
support ACOs in fully and equitably
participating in all payer/all patient
available at https://jamanetwork.com/journals/
jama/fullarticle/2805705.
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collection types with our proposed
creation of the APP Plus quality
measure set, our commitment to
monitor ACOs’ reporting of quality data
using Medicare CQMs and to assess
their appropriateness as a collection
type remains the same.
As we stated in the CY 2024 PFS final
rule, 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 as
described at § 414.1370 (88 FR 79099).
If our proposal is finalized, FQHCs and
RHCs that participate in Shared Savings
Program ACOs would have to report the
APP Plus quality measure set through
their ACO for performance year 2025
and subsequent performance years.
We seek comment on all of the
proposals described in this section.
(3) Proposed Changes to Regulation Text
As discussed in section III.G.4.b.(2)(a)
of this proposed rule, for performance
year 2025 and subsequent performance
years, we are proposing to require
Shared Savings Program ACOs to report
the APP Plus quality measure set as
proposed in section IV.A.4.c.(3) of this
proposed rule. The APP Plus quality
measure set would comprise of eleven
measures, consisting of six measures
from the APP quality measure set and
five newly proposed measures from the
Adult Universal Foundation measure set
that would be incrementally
incorporated into the APP Plus quality
measure set over performance years
2025 through 2028. We are also
proposing to focus the collection types
available to Shared Savings Program
ACOs for reporting the APP Plus quality
measure set to eCQMs and Medicare
CQMs. We refer readers to sections
IV.A.4.c, IV.A.4.e.(1)(b)(i),
IV.A.4.f.(1)(b)(iii), and IV.A.4.f.(1)(c)(i).
of this proposed rule for changes to the
regulation text at 42 CFR part 414. We
are proposing conforming changes to the
regulation text at 42 CFR part 425 as
described below in this section. We seek
comment on our proposed regulation
text changes.
• We are proposing to sunset the
requirement that ACOs must submit
quality data via the APP to satisfactorily
report on behalf of the eligible clinicians
who bill under the TIN of an ACO
participant for purposes of the MIPS
Quality performance category of the
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Quality Payment Program, and to revise
§ 425.508(b) to indicate that the
requirement will be applicable for
performance years beginning in 2021–
2024. We are also proposing to replace
the phrase ‘‘Alternative Payment Model
Performance Pathway (APP)’’ with the
phrase ‘‘APM Performance Pathway
(APP)’’ to conform with the phrase used
at § 414.1367.
• We are adding a new paragraph (c)
at § 425.508 to establish that, for
performance years beginning on or after
January 1, 2025, ACOs must submit
quality data via the APM Performance
Pathway (APP) on the quality measures
contained in the APP Plus quality
measure set established under
§ 414.1367 to satisfactorily report on
behalf of the eligible clinicians who bill
under the TIN of an ACO participant for
purposes of the MIPS Quality
performance category of the Quality
Payment Program.
• We are proposing to revise the
section heading at § 425.510 to
‘‘Application of the APM Performance
Pathway (APP) quality measure set or
the APP Plus quality measure set (as
applicable) to Shared Savings Program
ACOs for performance years beginning
on or after January 1, 2021.’’
• We are proposing to sunset the
requirement that ACOs must report
quality data on the APP quality measure
set according to the method of
submission established by CMS and to
revise § 425.510(b). We are adding a
new paragraph (b)(1) at § 425.510 to
indicate that the requirement will be
applicable for performance years
beginning in 2021–2024.
• We are adding a new paragraph
(b)(2) at § 425.510 to establish that, for
performance years beginning on or after
January 1, 2025, ACOs must report
quality data on the APP Plus quality
measure set established under
§ 414.1367, according to the submission
method established by CMS.
• We are revising § 425.512(a)(2)(iii)
to establish that, for performance year
2025 and subsequent performance years,
an ACO in the first performance year of
the ACO’s first agreement period under
the Shared Savings Program will meet
the quality performance standard if the
ACO reports the APP Plus quality
measure set and meets the data
completeness requirement on all
eCQMs/Medicare CQMs, and the
CAHPS for MIPS survey (except as
specified in § 414.1380(b)(1)(vii)(B)),
and receives a MIPS Quality
performance category score for the
applicable performance year.
• We are revising the introductory
paragraph (a)(5)(i) to § 425.512 to read
as follows: ‘‘Except as specified in
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paragraphs (a)(2) and (7) of this section,
CMS designates the quality performance
standard as:’’.
• We are revising the introductory
paragraph (a)(5)(i)(A) to read as follows:
‘‘For performance year 2024, the ACO
reporting quality data on the APP
quality measure set established under
§ 414.1367 of this subchapter, according
to the method of submission established
by CMS and –’’.
• We are revising the introductory
paragraph (a)(5)(i)(B) to read as follows:
‘‘For performance year 2025 and
subsequent performance years, the ACO
reporting quality data on the APP Plus
quality measure set established under
§ 414.1367 of this subchapter, according
to the method of submission established
by CMS and –’’.
• We are adding a new paragraph
(a)(5)(ii)(A) to § 425.512 to indicate that
an ACO will meet the alternative quality
performance standard for performance
year 2024 if the ACO reports quality
data on the APP quality measure set
established under § 414.1367 according
to the method of submission established
by CMS and 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 quality measure set.
• We are adding a new paragraph
(a)(5)(ii)(B) to § 425.512 to establish that
an ACO will meet the alternative quality
performance standard for performance
year 2025 and subsequent years if the
ACO reports the quality data on the APP
Plus quality measure set established
under § 414.1367 according to the
method of submission established by
CMS and 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 Plus quality measure set.
• We are revising
§ 425.512(a)(5)(iii)(B) to indicate that for
performance year 2025 and subsequent
performance years, an ACO will not
meet the quality performance standard
or the alternative quality performance
standard if the ACO does not report any
of the eCQMs/Medicare CQMs in the
APP Plus quality measure set and does
not administer a CAHPS for MIPS
survey (except as specified in
§ 414.1380(b)(1)(vii)(B)).
• We are revising § 425.512(a)(7)
introductory text and (a)(7)(i) and
adding new paragraphs (a)(7)(i)(A) and
(B) to indicate for performance year
2024, CMS will use the higher of the
ACO’s health equity adjusted Quality
performance category score or the
equivalent of the 40th percentile MIPS
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Quality performance category score
when an ACO reports all of the required
measures, meeting the data
completeness requirement for each
measure in the APP quality measure set
and receiving a MIPS Quality
performance category score and the
ACO meets either of the following:
++ The ACO’s total available measure
achievement points used to calculate
the ACO’s MIPS Quality performance
category score are reduced under
§ 414.1380(b)(1)(vii)(A).
++ At least one of the eCQMs/MIPS
CQMs/Medicare CQMs does not have a
benchmark as described at
§ 414.1380(b)(1)(i)(A).
• We are revising § 425.512(a)(7)(ii)
and adding new paragraphs (a)(7)(ii)(A)
and (B) to indicate for performance year
2025 and subsequent performance years,
an ACO will receive the higher of the
ACO’s health equity adjusted quality
performance category score or the
equivalent of the 40th percentile MIPS
Quality performance category score
when an ACO reports all of the required
measures in the APP Plus quality
measure set, meeting the data
completeness requirement for each
measure in the APP Plus quality
measure set, and receiving a MIPS
Quality performance category score, and
the ACO meets either of the following:
++ The ACO’s total available measure
achievement points used to calculate
the ACO’s MIPS Quality performance
category score are reduced under
§ 414.1380(b)(1)(vii)(A).
++ At least one of the eCQMs/
Medicare CQMs does not have a
benchmark as described at
§ 414.1380(b)(1)(i)(A).
• We are revising § 425.512(b)(1) and
(2) and (b)(4)(i) by removing the phrase
‘‘APP measure set’’ and replacing with
the phrase ‘‘APP quality measure set’’ to
align naming conventions for the two
quality measure sets within the APP: the
APP quality measure set and the APP
Plus quality measure set.
• We are revising § 425.512(b)(1) to
update a renumbered cross reference.
• We are revising the heading for
§ 425.512(b)(2) by removing the phrase
‘‘and subsequent performance years.’’
• We are renumbering the current
paragraph (b)(3) of § 425.512 to
paragraph (b)(4) and revising the cross
references therein to reflect this
renumbering.
• We are adding a new paragraph
(b)(3) to § 425.512 to establish for
performance year 2025 and subsequent
performance years that for an ACO that
reports all of the eCQMs/Medicare
CQMs in the APP Plus quality measure
set, meeting the data completeness
requirement for all of the eCQMs/
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Medicare CQMs, and administers the
CAHPS for MIPS survey (except as
specified in § 414.1380(b)(1)(vii)(B)),
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 Plus quality
measure set and the ACO’s health equity
adjustment bonus points. The sum of
these values may not exceed 100
percent.
• We are renumbering the current
paragraph (b)(4) of § 425.512 to
paragraph (b)(5) and revising the cross
references therein to reflect this
renumbering.
• We are revising renumbered
§ 415.512(b)(5)(iv) to add reference to
new paragraph (c)(3)(iv).
• We are revising § 425.512(c)(3)
introductory text by removing the
phrase ‘‘via the APP’’ and adding in its
place the phrase ‘‘on the APP quality
measure set or APP Plus quality
measure set (as applicable)’’.
• We are revising § 425.512(c)(3)(iii)
by removing the phrase ‘‘and
subsequent performance years’’ after
‘‘For performance year 2024’’.
• We are adding new paragraph
(c)(3)(iv) to § 425.512 to establish for
performance year 2025 and subsequent
performance years, if CMS determines
the ACO meets the requirements of the
Extreme and Uncontrollable
Circumstances policy and the ACO
reports the APP Plus quality measure
set, meets the data completeness
requirement, and receives a MIPS
Quality performance category score,
CMS will calculate the ACO’s quality
score as 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.
c. Proposed Changes to the Methodology
for Calculating the MIPS Quality
Performance Category Score for Shared
Savings Program ACOs Reporting the
APP Plus Quality Measure Set
(1) Background
Consistent with the authority to
establish the quality reporting and other
reporting requirements for the Medicare
Shared Savings Program set forth in
section 1899(b)(3) of the Act and the
statutory requirements for the Quality
Payment Program set forth in section
1848(q) and (r) of the Act for MIPS and
section 1833(z) of the Act for Advanced
APMs, since the Shared Savings
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Program’s alignment with the APP in
performance year 2021, MIPS eligible
clinicians identified on the Participation
List or Affiliated Practitioner List of an
APM Entity participating in a MIPS
APM—including ACOs that participate
in the Medicare Shared Savings
Program—that report data via the APP
have been scored according to the APP
scoring methodology described at
§ 414.1367. The MIPS Quality
performance category score is calculated
according to the APP scoring
methodology at § 414.1367(c)(1) (85 FR
84864). Under the waiver authority at
section 1115A(d)(1) of the Act for CMS
Innovation Center APMs and at section
1899(f) of the Act for the Medicare
Shared Savings Program, the Cost
performance category weight is zero
percent as described at § 414.1367(c)(2)
(85 FR 84864) for MIPS eligible
clinicians that report via the APP. As
noted in section 1848(q)(5)(C)(ii) of the
Act, a MIPS eligible clinician in an APM
for a performance period automatically
earns a minimum score of one half of
the highest potential score for the MIPS
Improvement activities category for
their participation in an APM for the
performance period. These baseline
scores are automatically applied to the
MIPS Improvement activities
performance category score for MIPS
eligible clinician in an APM—including
ACOs that participate in the Medicare
Shared Savings Program—that report via
the APP as described at § 414.1367(c)(3)
(85 FR 84865). The Promoting
Interoperability performance category
under the APP is reported and
calculated in the same manner
described at § 414.1375 (85 FR 84865).
As described in the CY 2021 PFS final
rule, we waived the requirement to
weight each MIPS performance category
as described in section 1848(q)(5)(E) of
the Act using the waiver authority in
section 1899(f) of the Act for Medicare
Shared Savings Program for MIPS
eligible clinicians that report via the
APP—including ACOs that participate
in the Medicare Shared Savings Program
(85 FR 84865). The performance
category weights used to calculate the
final score for a MIPS eligible clinician
who is scored through the APP at
§ 414.1367(d)(1) are:
• Quality: 50 percent.
• Cost: 0 percent.
• Improvement Activities: 20 percent.
• Promoting Interoperability: 30
percent.
Additionally, in the CY 2021 PFS
final rule, we also stated that under the
authority provided in section
1848(q)(5)(F) of the Act, it may become
necessary to reweight one or more
performance categories (85 FR 84866).
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As described at § 414.1367(d)(2), if CMS
determines, in accordance with
§ 414.1380(c)(2), that a different scoring
weight should be assigned to the
Quality or Promoting Interoperability
performance category, CMS will
redistribute the performance category
weights as follows:
• If CMS reweights the Quality
performance category to 0 percent:
Promoting Interoperability performance
category is reweighted to 75 percent,
and Improvement activities performance
category is reweighted to 25 percent.
• If CMS reweights the Promoting
Interoperability performance category to
0 percent: Quality performance category
is reweighted to 75 percent, and
Improvement activities performance
category is reweighted to 25 percent.
Lastly, as codified at § 414.1367(e),
final scoring for APM participants
reporting to MIPS through the APP—
including ACOs that participate in the
Medicare Shared Savings Program—
would follow the same methodology as
established for MIPS generally at
§ 414.1380 (85 FR 84866).
In performance year 2024, ACOs are
scored on either the three eCQMs/MIPS
CQMs/Medicare CQMs or the ten CMS
Web Interface measures, the CAHPS for
MIPS survey, and two administrative
claims-based measures. Under this
methodology, an ACO’s MIPS Quality
performance category score is calculated
according to MIPS scoring rules for the
Quality performance category
established at § 414.1380(b)(1) with
exceptions for (1) measures that do not
have a benchmark or do not meet the
case minimum requirement and (2)
measures that are identified as topped
out. Specifically, each submitted
measure that does not have a benchmark
or does not meet the case minimum
requirement is excluded from an ACO’s
total measure achievement points
(numerator) and total available measure
achievement points (denominator).
Additionally, any measure that is
identified as topped out is not subject to
the scoring cap described at
§ 414.1380(b)(1)(iv). Under current APP
scoring rules, each required measure of
the APP quality measure set that is not
submitted by an ACO via the APP
receives zero measure achievement
points.
(2) Proposed Revisions
(a) Proposal To Establish the Data
Submission Criteria for the APP Plus
Quality Measure Set
As discussed in section
IV.A.4.e.(1)(b)(i) of this proposed rule,
for the APP Plus quality measure set, we
are proposing that Shared Savings
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Program ACOs that report the APP Plus
quality measure set and MIPS eligible
clinicians, groups, and APM Entities
that choose to report the APP Plus
quality measure set, will be required to
report on all measures in the APP Plus
quality measure set, as applicable.
Specifically, in § 414.1335(b), we are
proposing to establish the data
submission criteria for the APP Plus
quality measure set, which would
require the reporting of all measures
within the APP Plus quality measure
set, except for administrative claimsbased quality measures.476
The MIPS Quality performance
category score is calculated according to
the APP scoring methodology at
§ 414.1367(c)(1) (85 FR 84864 through
85 FR 84865). As such, an ACO’s MIPS
Quality performance category score is
calculated according to MIPS scoring
rules for the Quality performance
category established at § 414.1380(b)(1)
with exceptions for (1) measures that do
not have a benchmark or do not meet
the case minimum requirement and (2)
measures that are identified as topped
out. Consistent with our proposal
described above, under § 414.1380(b)(1),
for performance year 2025 and
subsequent performance years, ACOs
would be scored on all required
measures in the APP Plus quality
measure set.
We are proposing that the policies
related to MIPS performance category
scoring in the APP at § 414.1367(c)
would apply to Shared Savings Program
ACOs that report the APP Plus quality
measure set for the purpose of meeting
the Shared Savings Program’s quality
performance standard.477 Specifically,
we are proposing that the APP scoring
policies at § 414.1367(c)(1) for the
calculation of the ACO’s MIPS Quality
performance category, § 414.1367(c)(2)
for the calculation of an ACO’s MIPS
Cost performance category,
§ 414.1367(c)(3) for the calculation of an
ACO’s MIPS Improvement activities
performance category, and
§ 414.1367(c)(4) for the calculation of an
ACO’s MIPS Promoting Interoperability
performance category would apply to
476 As described at § 414.1325(a)(2)(i), there are
no data submission requirements for administrative
claims-based quality measures as performance on
such measures is calculated by CMS using
administrative claims data, which includes claims
submitted with dates of service during the
applicable performance period that are processed
no later than 60 days following the close of the
applicable performance period.
477 This discussion describes standards under the
APP, which are applicable to APM Entities. We
refer throughout to ACOs in lieu of APM Entities
as we are discussing the application of APP
standards to ACOs participating in the Shared
Savings Program, and thus ACOs are the sole
relevant type of APM Entity.
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61859
ACOs that report the APP Plus quality
measure set in performance year 2025
and subsequent performance years.
Additionally, we are proposing that
§ 414.1367(d) for the performance
category weights and § 414.1367(e) for
the calculation of the final score would
apply to Shared Savings Program ACOs
that report the APP Plus quality
measure set in performance year 2025
and subsequent performance years.
If our proposals are finalized, then in
performance year 2025, ACOs would be
scored on the required eight measures in
the APP Plus quality measure set: five
eCQMs/Medicare CQMs, the CAHPS for
MIPS survey, and two administrative
claims-based measures. In performance
years 2026 and 2027, ACOs would be
scored on the required nine measures:
six eCQMs/Medicare CQMs, the CAHPS
for MIPS survey, and two administrative
claims-based measures. In performance
year 2028 and subsequent performance
years, ACOs would be scored on the
required eleven measures: eight eCQMs/
Medicare CQMs, the CAHPS for MIPS
survey, and two administrative claimsbased measures. We refer readers to
Tables 34, 35, and 36 in Section III.G.4.f
of this proposed rule for additional
detail on the required measures in each
performance year.
We refer readers to section
IV.A.4.e.(1)(b)(i) of this proposed rule
for a discussion of our proposal to
establish the data submission criteria for
the APP Plus quality measure set,
specifically the proposal to require the
reporting of all measures within the
APP Plus quality measure set.
(b) Proposal To Establish a Complex
Organization Adjustment for Virtual
Groups and APM Entities
To account for the organizational
complexities faced by Virtual Groups
and APM Entities, including Shared
Savings Program ACOs, when reporting
eCQMs, in section IV.A.4.f.(1)(b)(iii) of
this proposed rule, we are proposing to
establish a Complex Organization
Adjustment beginning in the CY 2025
performance period/2027 MIPS
payment year. A Virtual Group and an
APM Entity would receive one measure
achievement point for each submitted
eCQM that meets the case minimum
requirement at § 414.1380(b)(1)(iii) and
the data completeness requirement at
§ 414.1340. Each reported eCQM may
not score more than 10 measure
achievement points and the total
achievement points (numerator) may
not exceed the total available measure
achievement points (denominator) for
the quality performance category. The
Complex Organization Adjustment for a
Virtual Group or APM Entity may not
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exceed 10 percent of the total available
measure achievement points in the
quality performance category. The
adjustment would be added for each
measure submitted at the individual
measure level.
Since Shared Savings Program ACOs
are APM Entities, this proposal would
be applicable to Shared Savings
Program ACOs reporting the APP Plus
quality measure set beginning in
performance year 2025. We refer readers
to section IV.A.4.f.(1)(b)(iii) of this
proposed rule for discussion of our
proposal to establish the Complex
Organization Adjustment for Virtual
Groups and APM Entities.
As the Adult Universal Foundation
measures are phased into the APP Plus
quality measure set, ACOs that
participate in the Shared Savings
Program would be required to report on
a larger measure set relative to other
eCQM reporters. Under our proposal as
described in section III.G.4.f of this
proposed rule, the APP Plus quality
measure set for Shared Savings Program
ACOs would include eight measures
(five eCQMs/Medicare CQMs, two
administrative claims measures, and the
CAHPS for MIPS Survey measure) in
performance year 2025 (Table 34); nine
measures (six eCQMs/Medicare CQMs,
two administrative claims measures,
and the CAHPS for MIPS Survey
measure) in performance years 2026 and
2027 (Table 35); and eleven measures
(eight eCQMs/Medicare CQMs, two
administrative claims measures, and the
CAHPS for MIPS Survey measure) in
performance years 2028 and subsequent
performance years (Table 36).
(c) Proposal To Score Shared Savings
Program ACOs Reporting Medicare
CQMs Using Flat Benchmarks
In the CY 2024 PFS final rule, we
finalized our proposal to establish new
benchmarks for scoring ACOs on the
Medicare CQMs under MIPS in
alignment with MIPS benchmarking
policies (88 FR 79110). As historical
Medicare CQM data would not be
available, we finalized that for
performance years 2024 and 2025, we
will score Medicare CQMs using
performance period benchmarks. We
also finalized that, for performance year
2026 and subsequent performance years,
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), we will score
Medicare CQMs using historical
benchmarks.
A few commenters noted in our
proposal in the CY 2024 PFS proposed
rule (88 FR 79109–79110) their concern
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about ACOs being compared only to
other ACOs that report Medicare CQMs
since the Medicare CQMs would be
available only to Shared Savings
Program ACOs. One commenter stated
their preference to have their quality
performance compared to all other
participants on these measures, while
another commenter stated that CMS
should stop measuring ACOs against
each other and instead measure ACOs
on a national standard so that all ACOs
can pass and do not lose out on savings
due to arbitrary quality decile cut
points. In our response to these
comments, we stated that given that
benchmarks are specific to each
collection type and that we proposed to
establish Medicare CQMs as a new
collection type for only Shared Savings
Program ACOs, only ACO data will be
available to benchmark Medicare CQMs.
Additionally, the health equity
adjustment would be applicable to
Medicare CQMs for purposes of
determining shared savings payments/
losses. The application of the health
equity adjustment would help improve
performance when ACOs deliver high
quality care to underserved patient
populations. For these reasons, it is
appropriate to establish benchmarks for
Medicare CQMs that are consistent with
MIPS benchmarking policies. ACOs that
prefer to be compared to clinicians at
large may do so by reporting eCQMs or
MIPS CQMs, for which CMS calculates
a benchmark using data reported by
MIPS eligible clinicians reporting under
the chosen collection type.
In performance year 2022, ACOs had
a higher average performance on quality
measures they were required to report in
order to share in savings compared to
other similarly sized clinician groups
not in the Shared Savings Program.478
This includes statistically significant
higher performance for quality measures
related to diabetes and blood pressure
control; breast cancer and colorectal
cancer screening; tobacco screening and
smoking cessation; and depression
screening and follow-up.479 In shifting
to Medicare CQMs, ACO performance
would be benchmarked against other
ACOs only reporting Medicare CQMs.
Since ACOs are high performers relative
to comparably sized MIPS groups,
benchmarking Medicare CQMs using
only ACO data would lower some
478 Centers for Medicare & Medicaid Services
(2023). Medicare Shared Savings Program Saves
Medicare More Than $1.8 Billion in 2022 and
Continues to Deliver High-quality Care. [Press
release]. https://www.cms.gov/newsroom/pressreleases/medicare-shared-savings-program-savesmedicare-more-18-billion-2022-and-continuesdeliver-high.
479 Id.
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ACOs’ MIPS measure achievement
points on those measures. In other
words, high-performing ACOs could
earn lower measure achievement points
relative to comparable MIPS groups
because the Medicare CQM
benchmarking pool is comprised of
higher-than-average performance data–
in effect, creating a ‘‘tournament
approach’’ to scoring Medicare CQMs
wherein ACOs must compete with other
ACOs to earn measure achievement
points. This could be particularly
disadvantageous for ACOs that serve a
high proportion of underserved
populations because, while ACOs that
report eCQMs and/or Medicare CQMs
and serve a high proportion of
underserved populations are eligible for
health equity adjustment points, ACOs
must score in the top or middle thirds
of ACO measure performers to earn
health equity adjustment points.
As described in section III.G.4.b.(2)(b)
of this proposed rule, for performance
year 2025 and subsequent performance
years, we are proposing to streamline
the collection types available for Shared
Savings Program ACOs reporting the
APP Plus quality measure set to the
eCQM and Medicare CQM collection
types. Therefore, as discussed in section
IV.A.4.f.(1)(c)(i) of this proposed rule,
we are proposing to add
§ 414.1380(b)(1)(ii)(F) to state that
beginning in the CY 2025 performance
period/2027 MIPS payment year,
measures of the Medicare CQM
collection type would be scored using
flat benchmarks for their first two
performance periods in MIPS. Our
proposal in section IV.A.4.f.(1)(c)(i) of
this proposed rule would expand the
use of flat benchmarks to Medicare
CQMs in their first two performance
periods in MIPS. The use of flat
benchmarks would allow ACOs with
high scores to earn maximum or near
maximum achievement points while
allowing room for quality improvement
and rewarding that improvement in
subsequent years. Use of flat
benchmarks also helps to ensure that
ACOs with high quality performance on
a measure are not penalized as low
performers. As discussed in section
IV.A.4.f.(1)(c)(i) of this proposed rule,
we are proposing to add
§ 414.1380(b)(1)(ii)(F) to incorporate this
proposal. The use of historical
benchmarks, when data are available, is
consistent with MIPS benchmarking
policies at § 414.1380(b)(1)(ii), allow
ACOs to know benchmarks prior to start
of the performance year, and create
opportunities for improvement.
Table 30 lists the Medicare CQMs in
the APP Plus quality measure set that
would be eligible for flat benchmarks in
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performance year 2025 through
61861
performance year 2029 under our
proposal.
TABLE 30: Medicare CQMs Eligible for Flat Benchmarks in Performance Year
2025 through 2029
Performance Year
2025
2026
2027
2028
2029
A quality performance benchmark is
the performance rate an ACO must
achieve to earn the corresponding
quality points for each measure. Flat
benchmarks assign a performance rate
range to each decile. In flat benchmarks
for non-inverse measures, any
performance rate at or above 90 percent
would be in the top decile; any
performance rate between 80 percent
and 89.99 percent would be in the
second highest decile, and so on. For
inverse measures, this would be
reversed—any performance rate at or
Quality #
001, 134,236, 112, 113
112, 113, 305
305
487,493
487,493
below 10 percent would be in the top
decile; any performance rate between
10.01 percent and 20 percent would be
in the second highest decile, and so on.
The number of measure achievement
points received for each measure is
determined based on the applicable
benchmark decile category and the
percentile distribution.
For non-inverse measures, better
quality performance is indicated by a
higher performance rate. For example,
Quality #: 001 Controlling High Blood
Pressure is a non-inverse measure that
measures the percentage of patients 18–
85 years of age who had a diagnosis of
hypertension and whose blood pressure
was adequately controlled (<140/90
mmHg) during the measurement period.
Better quality performance on this
measure is demonstrated by having a
higher percentage of patients whose
blood pressure was adequately
controlled. Table 31 lists the flat
benchmarks for a non-inverse Medicare
CQM under our proposal described in
section IV.A.4.f.(1)(c)(i) of this proposed
rule.
TABLE 31: Flat Benchmarks for a Non-Inverse Medicare CQM in its First Two
Performance Periods in MIPS in Performance Year 2025 and Subsequent Years
Decile
Performance Rate Range
< 10.00
10.00 - 19.99
20.00 - 29.99
30.00 - 39.99
40.00 - 49.99
50.00 - 59.99
60.00 - 69.99
70.00 - 79.99
80.00 - 89.99
>= 90.00
performance rate. This is reflected in
flat benchmark such that lower quality
performance rates are found in higher
deciles. For example, Quality #: 001
Diabetes: Hemoglobin A1c (HbA1c) Poor
Control is an inverse quality measure
that measures the percentage of patients
18–75 years of age with diabetes who
had hemoglobin A1c >9.0 percent
during the measurement period. Better
quality performance on this measure is
demonstrated by having a lower
percentage of patients whose HbA1c
was >9.0 percent. Table 32 lists the flat
benchmarks for an inverse Medicare
CQM under our proposal described in
section IV.A.4.f.(1)(c)(i) of this proposed
rule.
EP31JY24.059
For example, if an ACO reports a noninverse Medicare CQM in its first two
performance periods in MIPS in
performance year 2025 and earns a
performance rate of 55.25 percent, then
the ACO would score in the 6th decile
on that measure.
For inverse measures, better quality
performance is indicated by a lower
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2
3
4
5
6
7
8
9
10
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TABLE 32: Flat Benchmarks for an Inverse Medicare CQM in its First Two Performance
Periods in MIPS in Performance Year 2025 and Subsequent Years
Decile
Performance Rate Rane:e
99.00- 90.01
90.00- 80.01
80.00- 70.01
70.00- 60.01
60.00- 50.01
50.00- 40.01
40.00- 30.01
30.00- 20.01
20.00- 10.01
<= 10.00
For example, if an ACO reports an
inverse Medicare CQM in its first two
performance periods in MIPS in
performance year 2025 and earns a
performance rate of 12.25 percent, then
the ACO would score in the 9th decile
on that measure. In performance year
2025, Quality #: 001 Diabetes:
Hemoglobin A1c (HbA1c) Poor Control
is the only inverse Medicare CQM
measure.
There are scoring scenarios in which
ACOs would earn higher measure
achievement points under flat
benchmarks compared to those they
would earn under performance period
benchmarks. Most notable are scenarios
in which ACOs have a tight distribution
of performance rates on a measure. For
example, a non-inverse measure for
which a performance rate of 90.00
percent is in the 8th decile. In this
example, an ACO that reported a
performance rate of 90.00 percent would
be scored in the 8th decile when the
hypothetical performance period
benchmark is applied. Using the flat
benchmarks described in Table 31 of
this proposed rule, an ACO that
reported a performance rate of 90.00
percent would be scored in the 10th
decile, resulting in greater measure
achievement points than under the
hypothetical performance period
benchmarks described in this example.
For more details on the calculation of
measure achievement points, we refer
readers to the ‘‘APM Performance
Pathway (APP) Toolkit’’ which is
updated for each performance year and
posted in the QPP Resource Library.
We seek comment on our proposal to
score ACOs reporting Medicare CQMs
using flat benchmarks in performance
year 2025 and subsequent performance
years.
(3) Proposed Changes to Regulation Text
As discussed in sections
III.G.4.c.(2)(a), III.G.4.c.(2)(b), and
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III.G.4.c.(2)(c) of this proposed rule, we
are proposing to establish scoring rules
to calculate the MIPS Quality
performance category score for ACOs
reporting the APP Plus quality measure
set for performance year 2025 and
subsequent performance years. We
believe that these proposed scoring
rules would incentivize the reporting of
eCQMs in the APP Plus quality measure
set while continuing to support ACOs
that report Medicare CQMs as they
build the infrastructure, skills,
knowledge, and expertise necessary to
aggregate patient data to report digital
quality measures. We refer readers to
sections IV.A.4.e.(1)(b)(i),
IV.A.4.f.(1)(b)(iii), and IV.A.4.f.(1)(c)(i)
of this proposed rule for changes to the
regulation text at 42 CFR part 414.
d. Proposal To Extend the eCQM
Reporting Incentive for Meeting the
Shared Savings Program Quality
Performance Standard
(1) Background
In the CY 2023 PFS final rule, we
extended the incentive for reporting
eCQMs/MIPS CQMs through
performance year 2024 to align with the
timeline for sunsetting of the CMS Web
Interface reporting option and to allow
ACOs an additional year to gauge their
performance on the eCQMs/MIPS CQMs
before full reporting of the measures are
required beginning in performance year
2025 (87 FR 69836 through 69838). We
originally adopted this incentive in the
CY 2022 PFS final rule to encourage
ACOs to begin the transition to eCQM/
MIPS CQM reporting in performance
years 2022 and 2023 (86 FR 65269). We
finalized an update to the incentive for
performance year 2024 such that:
• If an ACO reports the three eCQMs/
MIPS CQMs, meets the data
completeness requirement at § 414.1340
and the case minimum requirement at
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§ 414.1380 for all three eCQMs/MIPS
CQMs, and:
• 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;
• 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, the ACO will meet the
quality performance standard used to
determine eligibility for shared savings
and to avoid maximum shared losses, if
applicable.
We received a few comments on our
proposal in the CY 2023 PFS proposed
rule to extend the incentive for
reporting eCQMs/MIPS CQMs through
performance year 2024 suggesting that
we extend the incentive beyond 2024 to
facilitate the national shift towards
eCQMs. In our response in the CY 2023
PFS final rule (87 FR 69836), we stated
that ‘‘We are not extending the incentive
beyond performance year 2024 at this
time because this policy is intended to
align with the timeline for sunsetting of
the CMS Web Interface reporting option
at the end of performance year 2024. We
will continue to monitor the impact of
this policy as we gain more experience
with ACOs reporting eCQMs/MIPS
CQMs and may revisit the policy in
future rulemaking.’’
(2) Proposed Revisions
We are committed to continuing to
support ACOs in the transition to all
payer/all patient eCQMs and digital
quality measurement reporting. As
described in section III.G.4.b.(2)(a) of
this proposed rule, for performance year
2025 and subsequent performance years,
we are proposing to require Shared
Savings Program ACOs to report the
APP Plus quality measure set as
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proposed in section IV.A.4.c.(3) of this
proposed rule. The APP Plus quality
measure set would incrementally grow
to comprise of eleven measures,
consisting of six measures from the APP
quality measure set and five newly
proposed measures from the Adult
Universal Foundation measure set that
would be incrementally incorporated
into the APP Plus quality measure set
over performance years 2025 through
2028. We are also proposing to focus the
collection types available to Shared
Savings Program ACOs for reporting the
APP Plus quality measure set to all
payer/all patient eCQMs and Medicare
CQMs (while not adding the MIPS CQM
as an available collection type for
Shared Savings Program ACOs under
the APP Plus quality measure set).
The Shared Savings Program
continues to hear from ACOs and other
stakeholders about the challenges with
reporting on all payer/all patient
measures and meeting data management
requirements given their muti-practice/
multi EHR structure, the challenges to
aggregate data with the health IT
infrastructure in use by ACOs and
current state of interoperability. Shared
Savings Program quality reporting data
over the past two performance years
indicate that ACOs have been slow to
report eCQMs. In performance year
2021, 5 of 475 ACOs reported eCQMs
under the APP. In performance year
2022, among ACOs that reported quality
data under the APP, 24 out of 482
reported eCQMs with 7 of these ACOs
reporting a combination of eCQMs and
MIPS CQMs.480 We encourage ACOs,
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2021.
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especially those ACOs serving large,
underserved populations, to leverage
interoperability and digital data more
fully and to more quickly transition to
eCQMs. As such, we are proposing to
extend the eCQM reporting incentive to
performance year 2025 and subsequent
performance years to support ACOs in
meeting the Shared Savings Program
quality performance standard for
sharing in savings at the maximum rate
under its track.
Specifically, we are proposing that for
performance year 2025 and subsequent
performance years, an ACO will meet
the quality performance standard used
to determine eligibility for maximum
shared savings and to avoid maximum
shared losses, if applicable:
• If the ACO reports all of the eCQMs
in the APP Plus quality measure set
applicable for a performance year,
meeting the data completeness
requirement at § 414.1340 for all
eCQMs, and;
• 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 Plus
quality measure set, and;
• Achieves a quality performance
score equivalent to or higher than the
40th percentile of the performance
benchmark on at least one of the
remaining measures in the APP Plus
quality measure set.
The eCQM reporting incentive would
apply only to those ACOs that report all
of the eCQMs in the APP Plus quality
measure set applicable for a
performance year and meet the data
completeness requirement for all of the
eCQMs. The reporting incentive would
not apply to ACOs that report a
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combination of eCQMs/Medicare CQMs
or report only Medicare CQMs. We will
further assess the need for the eCQM
reporting incentive in the future as
ACOs continue the transition to
adopting eCQMs and may make
refinements as needed in future
rulemaking. The proposed APP Plus
quality measure set for Shared Savings
Program ACOs for performance year
2025, performance years 2026 and 2027,
and performance year 2028 and
subsequent performance years are
displayed in Tables 34, 35, and 36,
respectively. We included the measure
type in these tables for each measure in
the APP Plus quality measure set to
provide ACOs with a list of the outcome
measures for purposes of qualifying for
the eCQM reporting incentive.
(3) Proposed Changes to Regulation Text
We are proposing to add paragraphs
(a)(5)(i)(B)(1) and (2) to § 425.512 to
incorporate our proposal to extend the
eCQM reporting incentive to
performance year 2025 and subsequent
performance years into the regulation
text.
We seek comment on our proposal to
extend the eCQM reporting incentive to
performance year 2025 and subsequent
performance years.
e. Summary of Proposals
In Table 33 of this proposed rule, we
summarize the proposed changes to the
regulation at § 425.512(a)(5) to reflect
the changes we are proposing to the
quality reporting requirements and
quality performance standard for
performance year 2025 and subsequent
performance years.
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Performance Years 2026
and 2027
Performance Year 2028
and Subsequent
Performance Years
ACOs are required to report
6 eCQMs/Medicare CQMs
in the APP Plus quality
measure set and administer
the CAHPS for MIPS
survey. CMS will calculate
2 claims-based measures.
ACOs are required to report
8 eCQMs/Medicare CQMs
in the APP Plus quality
measure set and administer
the CAHPS for MIPS
survey. CMS will calculate
2 claims-based measures.
Quality performance
standard used to
determine eligibility for
maximum shared savings
and to avoid maximum
shared losses, if
applicable:
1. For ACOs that report
eCQMs/Medicare CQMs
and serve a high proportion
of underserved
beneficiaries, achieving 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, or
Quality performance
standard used to
determine eligibility for
maximum shared savings
and to avoid maximum
shared losses, if
applicable:
1. For ACOs that report
eCQMs/Medicare CQMs
and serve a high proportion
of underserved
beneficiaries, achieving 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, or
2. Reporting the 5 eCQMs
in the APP Plus quality
measure set, meeting the
data completeness
requirement at § 414.1340
for all 5 eCQMs, and
achieving a quality
performance score
equivalent to or higher than
the 10th percentile of the
performance benchmark on
at least 1 of the 4 outcome
measures in the APP Plus
quality measure set and a
quality performance score
equivalent to or higher than
the 40th percentile of the
performance benchmark on
at least 1 of the remaining 7
measures in the APP Plus
quality measure set.
2. Reporting the 6 eCQMs
in the APP Plus quality
measure set, meeting the
data completeness
requirement at § 414.1340
for all 6 eCQMs, and
achieving a quality
performance score
equivalent to or higher than
the 10th percentile of the
performance benchmark on
at least 1 of the 4 outcome
measures in the APP Plus
quality measure set and a
quality performance score
equivalent to or higher than
the 40th percentile of the
performance benchmark on
at least 1 of the remaining 8
measures in the APP Plus
quality measure set.
2. Reporting the 8 eCQMs
in the APP Plus quality
measure set, meeting the
data completeness
requirement at § 414.1340
for all 8 eCQMs, and
achieving a quality
performance score
equivalent to or higher than
the 10th percentile of the
performance benchmark on
at least 1 of the 4 outcome
measures in the APP Plus
quality measure set and a
quality performance score
equivalent to or higher than
the 40th percentile of the
performance benchmark on
at least I of the remaining
10 measures in the APP
Plus quality measure set.
Alternative quality
Alternative quality
Alternative quality
Performance Year 2025
Shared Savings
Program ACO
Quality Reporting
Requirements
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Program ACO
Quality
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Alternative Quality
Performance
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ACOs are required to report
the 5 eCQMs/Medicare
CQMs in the APP Plus
quality measure set and
administer the CAHPS for
MIPS survey. CMS will
calculate 2 claims-based
measures.
Quality performance
standard used to
determine eligibility for
maximum shared savings
and to avoid maximum
shared losses, if
applicable:
1. For ACOs that report
eCQMs/Medicare CQMs
and serve a high proportion
of underserved
beneficiaries, achieving 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, or
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TABLE 33: Proposed APP Plus Quality Measure Set Reporting Requirements and Quality
Performance Standard for Shared Savings ACOs for Performance Year 2025 and
Subsequent Performance Years
Performance Year 2025
Performance Years 2026
and 2027
performance standard
used to determine shared
savings using the sliding
scale methodology:
An ACO that fails to meet
the criteria above but meets
the alternative quality
performance standard by
achieving a quality
performance score
equivalent to or higher than
the 10th percentile of the
performance benchmark on
at least lofthe 4 outcome
measures in the APP Plus
quality measure set would
share in savings (if
otherwise eligible) at a
lower rate that is scaled by
the ACO's health equity
adjusted quality
performance score.
performance standard
used to determine shared
savings using the sliding
scale methodology:
An ACO that fails to meet
the criteria above but meets
the alternative quality
performance standard by
achieving a quality
performance score
equivalent to or higher than
the 10th percentile of the
performance benchmark on
at least 1 of the 4 outcome
measures in the APP Plus
quality measure set would
share in savings (if
otherwise eligible) at a
lower rate that is scaled by
the ACO's health equity
adjusted quality
performance score.
Performance Year 2028
and Subsequent
Performance Years
performance standard
used to determine shared
savings using the sliding
scale methodology:
An ACO that fails to meet
the criteria above but meets
the alternative quality
performance standard by
achieving a quality
performance score
equivalent to or higher than
the 10th percentile of the
performance benchmark on
at least 1 of the 4 outcome
measures in the APP Plus
quality measure set would
share in savings (if
otherwise eligible) at a
lower rate that is scaled by
the ACO's health equity
adjusted quality
performance score.
lfan ACO (1) does not
report any of the 5 eCQMs
/Medicare CQMs in the
APP Plus quality measure
set and (2) does not
administer a CAHPS for
MIPS survey, the ACO will
not meet the quality
performance standard or the
alternative quality
performance standard. This
ACO will be ineligible to
share savings and will owe
maximum shared losses, if
applicable.
!fan ACO (1) does not
report any of the 6 eCQMs
/Medicare CQMs in the
APP Plus quality measure
set and (2) does not
administer a CAHPS for
MIPS survey, the ACO will
not meet the quality
performance standard or the
alternative quality
performance standard. This
ACO will be ineligible to
share savings and will owe
maximum shared losses, if
aoolicable.
Ifan ACO (1) does not
report any of the 8 eCQMs
/Medicare CQMs in the
APP Plus quality measure
set and (2) does not
administer a CAHPS for
MIPS survey, the ACO will
not meet the quality
performance standard or the
alternative quality
performance standard. This
ACO will be ineligible to
share savings and will owe
maximum shared losses, if
aoolicable.
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f. Proposed APP Plus Quality Measure
Set
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(1) Background
The APP quality measure set for
performance year 2024 and subsequent
performance years was finalized in the
CY 2024 PFS final rule (88 FR 79112
through 79114). In that final rule, for
performance year 2024 and subsequent
performance years, we also finalized the
addition to the APP quality measure set
of the Medicare CQM collection type for
Diabetes: Hemoglobin A1c (HbA1c) Poor
Control (Quality #: 001), Preventive Care
and Screening: Screening for Depression
and Follow-up Plan (Quality #: 134),
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and Controlling High Blood Pressure
(Quality #: 236).
(2) Proposed Revisions
As described in section III.G.4.b.(2)(a)
of this proposed rule, for performance
year 2025 and subsequent performance
years, we are proposing to require
Shared Savings Program ACOs to report
the APP Plus quality measure set as
proposed in section IV.A.4.c.(3) of this
proposed rule. The APP Plus quality
measure set would comprise of eleven
measures, consisting of six measures
from the APP quality measure set and
five newly proposed measures from the
Adult Universal Foundation measure set
that would be incrementally
incorporated into the APP Plus quality
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61865
measure set over performance years
2025 through 2028. We are also
proposing to focus the collection types
available to Shared Savings Program
ACOs for reporting the APP Plus quality
measure set to all payer/all patient
eCQMs and Medicare CQMs.
The proposed APP Plus quality
measure set for Shared Savings Program
ACOs for performance year 2025,
performance years 2026 and 2027, and
performance year 2028 and subsequent
performance years are displayed in
Tables 34, 35, and 36, respectively. In
these tables, we also included the
measure type for each measure in the
APP Plus quality measure set to provide
ACOs with a list of the outcome
measures for purposes of qualifying for
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performance standard to qualify for the
maximum sharing rate, but that achieve
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
the eCQM reporting incentive, as
described in section III.G.4.d. of this
proposed rule. This information is also
relevant to the alternative quality
performance standard under which
ACOs that fail to meet the quality
APP Plus quality measure set, may be
eligible to share in savings on a sliding
scale, as discussed in the current
§ 425.512(a)(4)(ii).
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TABLE 34: Measures Included in the APP Plus Quality Measure Set for Shared
S
ACO ti P rfi
Y
2025
- P
I
(Jualit) #
l\leasure litle
I
I
I\ leaningfu I
l\leasures 2.0
,\rea
l\leasure T~ pe
Third Party
Intermediarv
N/A
PersonCentered Care
Affordability
and Efficiency
Patient
Engagement/Experience
Outcome"
Administrative
Claims
N/A
Affordability
and Efficiency
Outcome"
eCQM/Medicare
COM
eCQM/Medicare
CQM
APM Entity/Third
Party Intermediary
APM Entity/Third
Party Intermediary
Chronic
Conditions
Behavioral
Health
Intermediate Outcome"
l ,:k,tio" I, p,
Suhmitter l~pe
CAHPS for
MIPS Survey
Administrative
Claims
I
I
321
CAHPS for MIPS
479
Hospital-Wide, 30-day, AllCause Unplanned
Readmission (HWR) Rate
for MIPS Eligible Clinician
Groups
Clinician and Clinician
Group Risk-standardized
Hospital Admission Rates
for Patients with Multiple
Chronic Conditions
Diabetes: Hemoglobin Ale
(HbA 1c) Poor Control
Preventive Care and
Screening: Screening for
Depression and Follow-up
Plan
Controlling High Blood
Pressure
Colorectal Cancer Screening
484
001
134
236
Process
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eCQM/Medicare
APM Entity/Third
Chronic
Intermediate Outcome"
CQM
Partv Intermediarv
Conditions
eCQM/Medicare
APM Entity/Third
113
Wellness and
Process
Partv Intermediarv
Prevention
COM
112
Breast Cancer Screening
eCQM/Medicare
APM Entity/Third
Wellness and
Process
Partv Intermediarv
Prevention
COM
" Indicates this is an outcome measure for purposes of qualifying for the eCQM reporting incentive and the
alternative quality performance standard.
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TABLE 35: Measures Included in the APP Plus Quality Measure Set for Shared Savings
Program ACOs for Performance Years 2026 and 2027
Quality#
Measure Title
Collection Type
Submitter
Type
321
CARPS for MIPS
CARPS for MIPS
Survey
Third Party
Intermediary
479
Hospital-Wide, 30day, All-Cause
Unplanned
Readmission
(HWR) Rate for
MIPS Eligible
Clinician Groups
Clinician and
Clinician Group
Risk-standardized
Hospital
Admission Rates
for Patients with
Multiple Chronic
Conditions
Diabetes:
Hemoglobin A 1c
(HbA I c) Poor
Control
Preventive Care
and Screening:
Screening for
Depression and
Follow-up Plan
Controlling High
Blood Pressure
Administrative
Claims
NIA
Affordability
and Efficiency
Administrative
Claims
NIA
Affordability
and Efficiency
Outcome
eCQM/Medicare
CQM/
APM
Chronic
Conditions
Intermediate
Outcome'
eCQM/Medicare
CQM
APM
Behavioral
Health
Process
Chronic
Conditions
Intermediate
Outcome'
113
Colorectal Cancer
Screening
eCQM/Medicare
CQM
Wellness and
Prevention
Process
112
Breast Cancer
Screening
eCQM/Medicare
CQM
Wellness and
Prevention
Process
Initiation and
Engagement of
Substance Use
Disorder Treatment
eCQM/Medicare
CQM
Behavioral
health
Process
484
001
134
236
305
eCQM/Medicare
CQM
Entity/Third
Party
Intermediary
Entity/Third
Party
Intermediary
APM
Entity /Third
Party
Intermediary
APM
Entity/Third
Party
Intermediary
APM
Entity/Third
Party
Intermediary
APM
Entity/Third
Party
Intermediary
Meaningful
Measures 2.0
Area
PersonCentered Care
Measure Type
Patient
Engagement/E
xperience
Outcome
A
A
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alternative quality performance standard.
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TABLE 36: Measures Included in the APP Plus Quality Measure Set for Shared Savings
Proe;ram ACOs for Performance Year 2028 and Subsequent Performance Years
Quality#
Measure Title
321
CAHPS for MIPS
479
Hospital-Wide, 30day, All-Cause
Unplanned
Readmission
(HWR) Rate for
MIPS Eligible
Clinician Groups
Clinician and
Clinician Group
Risk-standardized
Hospital
Admission Rates
for Patients with
Multiple Chronic
Conditions
Diabetes:
Hemoglobin Ale
(HbAlc) Poor
Control
Preventive Care
and Screening:
Screening for
Depression and
Follow-up Plan
Controlling High
Blood Pressure
484
001
134
236
113
Colorectal Cancer
Screening
Collection Type
CAHPS for
MIPS Survey
Submitter
Type
Third Party
Intermediary
Meaningful
Measures
2.0 Area
PersonCentered
Care
Affordability
and
Efficiency
Measure Type
Patient
Engagement/Experience
A
Administrative
Claims
NIA
Administrative
Claims
NIA
Affordability
and
Efficiency
Outcome
eCQM/Medicare
APM
Entity /Third
Chronic
Conditions
Intermediate Outcome"
CQM
Behavioral
Health
Process
Chronic
Conditions
Intermediate Outcome"
Wellness and
Prevention
Process
W cllncss and
Prevention
Process
Behavioral
health
Process
Equity
Process
Outcome
,,
Party
Intermediary
eCQM/Medicare
APM
CQM
Entity/Third
Party
Intermediary
eCQM/Medicare
APM
CQM
Entity/Third
Party
Intermediarv
APM
Entity/Third
eCQM/Medicare
CQM
Party
Intermediarv
112
305
487
Initiation and
Engagement of
Substance Use
Disorder
Treatment
Screening for
Social Drivers of
Health
Adult
Immunization
Status
cCQM/Mcdicarc
CQM
APM
Entity /Third
Party
Intermediarv
eCQM/Medicare
APM
CQM
Entity/Third
Party
Intermediary
eCQM/Medicare
APM
CQM
Entity/Third
Party
Intermediarv
eCQM/Medicare
APM
Wellness and Process
Entity/Third
Prevention
Party
Intermediarv
'' Indicates this is an outcome measure for purposes of qualifying for the eCQM reporting incentive and the
alternative quality performance standard.
CQM
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493
Breast Cancer
Screening
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
g. Survey Modes for the Administration
of the Consumer Assessment of
Healthcare Providers and Systems
(CAHPS) for MIPS Survey Request for
Information
We seek public comment on the
potential expansion of the survey modes
of the CAHPS for MIPS Survey from a
mail-phone protocol to a web-mailphone protocol. During the 2023 CAHPS
for MIPS Web Mode Field Test,481
adding the web-based survey mode to
the current mail-phone protocol of
CAHPS for MIPS survey administration
resulted in an increased response rate.
Additional information on the CAHPS
for MIPS Survey Request for
Information is available in section
IV.A.4.e.(1)(e) of this proposed rule.
5. Providing the Option of Prepaid
Shared Savings
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a. Background
In the CY 2023 PFS final rule (87 FR
69782 through 69805), CMS 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 payment (AIP) and the
payments themselves are referred to as
advance investment payments.
These payments are intended to
improve the quality and efficiency of
items and services furnished to
Medicare beneficiaries by reducing the
barriers to participation in the Shared
Savings Program by supporting
investments in increased staffing,
healthcare infrastructure, and the
provision of accountable care for
underserved beneficiaries. Accordingly,
advance investment payments must be
spent on one of the following categories:
increased staffing, healthcare
infrastructure, and the provision of
accountable care for underserved
beneficiaries, which may include
addressing social determinants of health
(42 CFR 425.630(e)(1)).
Advance investment payments are
only available to ACOs newly entering
the Shared Savings Program in their first
agreement period (§ 425.630(b)(1)).
Many commentors on the CY 2023 PFS
final rule (87 FR 69782 through 69805)
suggested that CMS should expand
access to advance investment payments
by expanding the eligibility criteria to
include currently participating ACOs as
well as high revenue ACOs. While we
do not believe that it is appropriate to
481 https://qpp-cm-prodcontent.s3.amazonaws.com/uploads/2893/2023_
CAHPS_for_MIPS_WebMode_Field_Test.pdf.
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expand the eligibility criteria for
advance investment payments at this
time, as CMS still needs time to assess
the impact of the new payment option,
there is persuasive evidence that
investment in staffing, healthcare
infrastructure, and accountable care for
underserved beneficiaries could be
valuable for all ACOs, not just those that
are new to the program. Investment in
care coordination for beneficiaries
reduces costs and improve the quality of
care received.482 483 484 Investment in
health information technology can be
leveraged to empower individuals,
address patients’ full range of health
needs, promote healthy behaviors, and
facilitate better health outcomes for
individuals, families, and
communities.485 Additionally, there is
evidence that investment in services not
currently covered by Medicare may
improve beneficiary health and reduce
avoidable health care utilization costs
over time, including coverage of
482 Breckenridge ED, Kite B, Wells R, Sunbury
TM. Population Health Management. Effect of
Patient Care Coordination on Hospital Encounters
and Related Costs. September 26, 2019. Available
at https://doi.org/10.1089/pop.2018.0176.
483 Elliott MN, Adams JL, Klein DJ, et al. Journal
of General Internal Medicine. Patient-Reported Care
Coordination is Associated with Better Performance
on Clinical Care Measures. September 20, 2021.
Available at https://link.springer.com/article/
10.1007/s11606-021-07122-8.
484 Figueroa JF, Feyman Y, Zhou X, et al.
Hospital-level care coordination strategies
associated with better patient experience. BMJ
Quality & Safety. April 4, 2018. Available at https://
qualitysafety.bmj.com/content/27/10/844.
485 The Office of the National Coordinator for
Health Information Technology. 2020–2025 Federal
Health IT Strategic Plan. Available at https://
www.healthit.gov/sites/default/files/page/2020-10/
Federal%20Health%20IT%20Strategic%20Plan_
2020_2025.pdf.
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dental 486 487 488 hearing 489 490 and
vision 491 care.
Furthermore, we have come to
understand that, for beneficiaries, the
benefits of receiving services from
providers associated with ACOs—such
as improvements in quality and
coordinated care—may not be
immediately apparent. By encouraging
ACOs to invest in new services that
beneficiaries otherwise would not
receive, like hearing, vision and dental
services, the benefits of receiving care
from providers who are part of an ACO
would become more tangible. This
would encourage beneficiaries to
receive care from providers
participating in an ACO and may
ultimately result in improved quality
and efficiency of care for beneficiaries.
For ACOs that are currently
participating in the Shared Savings
Program and that reinvest their earned
shared savings payments in activities
that reduce costs and improve quality of
care, it could be more valuable to gain
access to those shared savings payments
early in and/or throughout each
performance year, instead of waiting
months after the end of each
performance year when any earned
shared savings payments are
distributed. Currently, CMS completes
the financial reconciliation calculations
for each ACO during the summer after
the end of each performance year,
which allows time for claims runout
486 Schenkein HA, Loos BG. Inflammatory
mechanisms linking periodontal diseases to
cardiovascular diseases. Journal of Clinical
Periodontology. April 30, 2013. Available at https://
doi.org/10.1111/jcpe.12060.
487 Teeuw WJ, Gerdes VE, Loos BG. Effect of
periodontal treatment on glycemic control of
diabetic patients: a systematic review and metaanalysis. Diabetes Care. February 2010. Available at
https://pubmed.ncbi.nlm.nih.gov/20103557/.
488 Allareddy V, Rampa S, Lee MK, Allareddy V,
Nalliah RP. Hospital-based emergency department
visits involving dental conditions: Profile and
predictors of poor outcomes and resource
utilization. The Journal of the American Dental
Association. November 19, 2014. Available at
https://doi.org/10.14219/jada.2014.7.
489 Choi JS, Adams ME, Crimmins EM, Lin FR,
Ailshire JA. Association between hearing aid use
and mortality in adults with hearing loss in the
USA: a mortality follow-up study of a crosssectional cohort. The Lancet Healthy Longevity.
January 3, 2024. Available at https://doi.org/
10.1016/S2666-7568(23)00232-5.
490 Reed NS, Altan A, Deal JA, et al. Trends in
Health Care Costs and Utilization Associated with
Untreated Hearing Loss Over 10 Years. JAMA
Otolaryngology—Head and Neck Surgery.
November 8, 2018. Available at https://
jamanetwork.com/journals/jamaotolaryngology/
fullarticle/2714049.
491 Lipton BJ, Decker SL. The effect of health
insurance coverage on medical care utilization and
health outcomes: Evidence from Medicaid adult
vision benefits. Journal of Health Economics.
November 11, 2015. Available at https://doi.org/
10.1016/j.jhealeco.2015.10.006.
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and other necessary data to become
available. CMS compares the updated
historical benchmark to an ACO’s
assigned beneficiaries’ per capita
expenditures during the performance
year to determine whether the ACO may
share in savings or losses, if owed. CMS
then notifies the ACO in writing
regarding whether the ACO qualifies for
a shared savings payment, and if so, the
amount of the payment due. These
payments are generally distributed to
ACOs in the early fall following the end
of each performance year. This is the
sole payment CMS makes to an ACO in
the Shared Savings Program and
generally an ACO’s sole source of
revenue. Distributing prepaid shared
savings during a performance year
would allow ACOs to invest these
payments in additional services for
assigned beneficiaries, staffing, and
healthcare infrastructure earlier and
reap the benefits from that investment
earlier.
The CMS Innovation Center tested a
number of strategies for providing more
experienced ACOs with advances of
funding during each performance year.
One of the innovations was the
infrastructure payments available in the
Next Generation ACO model, a CMS
Innovation Center model that was
intended for more experienced ACOs.492
Most Next Generation ACOs (82
percent) that participated in the Next
Generation ACO model in 2018 had
prior experience as Medicare ACOs
before starting in the model, and the
majority (56 percent) previously
participated in the Shared Savings
Program.493 ACOs selecting the
infrastructure payment option received
$6 per assigned beneficiary per month
to support ACO Activities, which was
later recouped during financial
settlement following each performance
year. The model defined ACO Activities
as activities related to promoting
accountability for the quality, cost, and
overall care for the population of
beneficiaries assigned to the Next
Generation ACO, including managing,
and coordinating care; encouraging
investment in healthcare infrastructure
and redesigned care processes for high
quality and efficient service delivery; or
carrying out any other obligation or duty
of the ACO under the terms of the Next
492 Refer to ‘‘Next Generation ACO Model’’
available at https://www.cms.gov/priorities/
innovation/innovation-models/next-generation-acomodel.
493 NORC at the University of Chicago. Next
Generation Accountable Care Organization Model
Third Evaluation Report. September 2020.
Available at https://www.cms.gov/priorities/
innovation/data-and-reports/2020/nextgenacothirdevalrpt-fullreport.
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Generation ACO model. Examples of
these activities included, but were not
limited to, providing direct patient care
in a manner that reduces costs and
improves quality; promoting evidencebased medicine and patient engagement;
reporting on quality and cost measures;
coordinating care, such as through the
use of telehealth, remote patient
monitoring, and other enabling
technologies; establishing and
improving clinical and administrative
systems for the ACO; meeting the
quality performance standards;
evaluating health needs; communicating
clinical knowledge and evidence-based
medicine; and developing standards for
beneficiary access and communication,
including beneficiary access to medical
records. In interviews performed as part
of the CMS Innovation Center’s
evaluation of the model, Next
Generation ACO leaders described using
these funds to support upfront operating
costs and healthcare infrastructure and
clinical process enhancements such as
new staff, health information
technology, data analytic capacity,
population health management, or care
coordination.494
Despite these ACOs’ prior experience
as Medicare ACOs and the meaningful
investments many had made in their
own healthcare infrastructure and
providers, they still found value in
access to funding during the
performance year. Almost all Next
Generation ACOs used the funds to
develop workflows informed by data
analytics and clinical staff input. Most
Next Generation ACOs also reported
using the funds to support care
management, such as acquiring tools
and developing healthcare
infrastructure to support care
coordination. Leaders from many Next
Generation ACOs described how the
payments facilitated new processes for
seamless patient care handoffs between
health care providers, enabled the
creation of better workflows for
scheduling follow-up visits, and
supported provision of screenings and
assessments. Data from a clinician
survey suggested that the payments
were likely helpful in improving the
delivery or coordination of care, with 63
percent of providers agreeing that
additional resources to support practice
changes made their day-to-day work
easier.495 Separately, the ACO
494 NORC at the University of Chicago. Evaluation
of the Next Generation Accountable Care
Organization (NGACO) Model—Final Report.
January 2024. Available at https://www.cms.gov/
priorities/innovation/data-and-reports/2024/
nextgenaco-sixthevalrpt.
495 NORC at the University of Chicago. Next
Generation Accountable Care Organization
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Investment Model (AIM), a model run
by the CMS Innovation Center which
informed development of the advance
investment payments, gave participating
ACOs upfront and quarterly funding to
spend on ACO start-up costs. These
ACOs primarily invested in staffing and
healthcare infrastructure including care
management, ACO administration,
health IT and data analysis,496 and these
ACOs generated an estimated net
aggregate reduction in spending by
Medicare of $381.5 million after
accounting for Medicare’s payment of
AIM funds and participating ACOs’
earned shared savings.497
Section 1899(i)(3) of the Act
authorizes the Secretary to use other
payment models instead of the onesided model described in section
1899(d) of the Act so long as the
Secretary determines that the other
payment model will improve the quality
and efficiency of items and services
furnished to Medicare beneficiaries
without additional program
expenditures. We are interested in
building on experience from the Next
Generation ACO model, and we agree,
in part, with comments on the CY 2023
PFS final rule that encouraged CMS to
expand AIP to additional ACOs. While
we do not believe it is appropriate to
expand the eligibility criteria for AIPs at
this time as explained earlier in this
section, we agree with commenters that
additional ACOs could benefit from
expanded access to performance year
funding that encourages investment in
staffing, healthcare infrastructure, and
additional services for beneficiaries.
Prepaid shared savings would be
required to be spent at least partially on
direct beneficiary services, improving
the quality of care beneficiaries receive.
Consequently, under the authority
provided to the Secretary by section
1899(i)(3) of the Act, we are proposing
to provide prepaid shared savings to
certain ACOs that meet the eligibility
criteria described in section III.G.5.b of
this proposed rule. Such payments
would be made pursuant to the
standards we propose to establish in
new § 425.640. This new payment
(NGACO) Model Evaluation Third Evaluation
Report. 2020. Available at https://www.cms.gov/
priorities/innovation/data-and-reports/2020/
nextgenaco-thirdevalrpt-fullreport.
496 Abt Associates, Evaluation of the Accountable
Care Organization Investment Model, AIM
Implementation and Impacts over Two Performance
Years (September 2019), page 55. Available at
https://www.cms.gov/priorities/innovation/aimsecond-annrpt.pdf.
497 Abt Associates, Evaluation of the Accountable
Care Organization Investment Model, Final Report
(September 2020), page 39. Available at https://
innovation.cms.gov/data-and-reports/2020/aimfinal-annrpt.
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option would provide prepaid shared
savings to ACOs with a history of
earning shared savings while
participating in the Shared Savings
Program. These payments would be
distributed on a quarterly basis and
would be recouped from shared savings
CMS determines the ACO to have
earned during the annual financial
reconciliation cycle. Prepaid shared
savings would be the advance payment
of shared savings that are expected to be
earned by the ACO and are covered
under the Shared Savings Distribution
Waiver (76 FR 66726). If the ACO does
not earn sufficient shared savings to
offset the advanced payment of shared
savings during the applicable
performance year, CMS may withhold
or terminate the ACO’s prepaid shared
savings under proposed
§ 425.640(h)(1)(iii).
We have determined that the other
payment model CMS has adopted under
section 1899(i)(3) of the Act would
continue to improve the quality and
efficiency of care should this proposal
be finalized. Section 1899(i)(3)(A) of the
Act requires CMS determine that the
other payment model will improve the
quality and efficiency of items furnished
under the Medicare program. Based on
the evidence for direct beneficiary
services noted above, our experience
administering the Shared Savings
Program, and the CMS Innovation
Center’s experience with the ACO
Investment Model and infrastructure
payments in the Next Generation ACO
model, we have determined that
allowing ACOs access to funding earlier
than currently available, in the form of
prepaid shared savings, would allow
ACOs to more rapidly achieve the
benefits of investing in staffing,
healthcare infrastructure, and direct
beneficiary services. Improvement in
these areas would improve the quality
and efficiency of beneficiary care
therefore meeting the standard of
section 1899(i)(3)(A) of the Act. As we
explained earlier in this section, ACOs
have expenditures throughout the PY,
particularly when implementing care
coordination and beneficiary
management strategies, and having
access to their shared savings early can
help ensure the ACO has adequate
funding to perform these services
throughout the year.
Section 1899(i)(3)(B) of the Act
requires CMS to determine that prepaid
shared savings, when implemented in
combination with existing modifications
made to the Shared Savings Program
payment model specified in section
1899(d) of the Act, will not result in
additional program expenditures. The
addition of prepaid shared savings
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meets this standard in part because the
eligibility criteria for prepaid shared
savings have been selected to only
permit ACOs that CMS estimates are
most likely to earn shared savings to
receive payments. Additionally, any
payments the ACO receives under this
proposal must be repaid to CMS, and
CMS would be protected by the ACOs’
repayment mechanisms in the event that
an ACO does not earn shared savings or
cannot otherwise repay the amount
owed to CMS. Based on this design, we
estimate that there would be no
additional program expenditures
stemming from the implementation of
prepaid shared savings under this
proposal. Please review section VII of
this proposed rule for a more complete
discussion of the financial impact of the
Shared Savings Program payment
model, including the findings necessary
to demonstrate compliance with section
1899(i)(3)(B) of the Act.
We intend to periodically reassess
whether a payment model established
under section 1899(i)(3) of the Act,
including the payment of prepaid
shared savings, continues to improve
the quality and efficiency of items and
services furnished to Medicare
beneficiaries without resulting in
additional program expenditures. If we
determine that the payment model no
longer satisfies the requirements of
section 1899(i)(3) of the Act (for
example if the payment model results in
net program costs), we would undertake
additional notice and comment
rulemaking to adjust our payment
methodology to assure continued
compliance with the statutory
requirements.
b. Eligibility
To ensure that prepaid shared savings
are provided only to ACOs that are wellpositioned to use prepaid shared
savings to improve the quality and
efficiency of care to their assigned
beneficiaries while minimizing the risk
of an ACO being unable to repay
prepaid shared savings, we propose to
limit the availability of prepaid shared
savings to those ACOs that have a track
record of success in the Shared Savings
Program. This approach is also
consistent with our compliance with
section 1899(i)(3)(B) of the Act as such
ACOs are most likely to be able to repay
the upfront funding through earned
shared savings.
We propose to establish the eligibility
criteria for prepaid shared savings in
§ 425.640(b). CMS must determine that
an ACO meets all of the following
criteria for the ACO to be eligible to
receive prepaid shared savings during
an agreement period:
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• The ACO is a renewing ACO as
defined under § 425.20 entering an
agreement period beginning on January
1, 2026, or in subsequent years.
• The ACO must have received a
shared savings payment for the most
recent performance year that:
(A) Occurred prior to the agreement
period for which the ACO has applied
to receive prepaid shared savings; and
(B) CMS has conducted financial
reconciliation.
• The ACO must have a positive prior
savings adjustment as calculated per
§ 425.658 at application disposition for
the agreement period in which they
would receive prepaid shared savings.
• The ACO does not have any
outstanding shared losses or advance
investment payments that have not yet
been repaid to CMS after reconciliation
for the most recent performance year for
which CMS completed financial
reconciliation.
• If the ACO received prepaid shared
savings in the current agreement period
or a prior agreement period, the ACO
must have fully repaid the amount of
prepaid shared savings received through
the most recent performance year for
which CMS has completed financial
reconciliation.
• The ACO is participating in Levels
C–E of the BASIC track or the
ENHANCED track during the agreement
period in which they would receive
prepaid shared savings.
• The ACO has in place an adequate
repayment mechanism in accordance
with § 425.204(f) that can be used to
recoup outstanding prepaid shared
savings.
• During the agreement period
immediately preceding the agreement
period in which the ACO would receive
prepaid shared savings, the ACO:
(A) Met the quality performance
standard as specified under § 425.512;
and
(B) Has not been determined by CMS
to have avoided at-risk beneficiaries as
specified under § 425.316(b)(2).
These eligibility criteria have been
selected to allow only ACOs with a
record of meeting the quality
performance standard, not avoiding at
risk beneficiaries, and recent success in
earning shared savings to receive
prepaid shared savings. This is for the
protection of both CMS and the ACOs,
as CMS does not want to overestimate
an ACO’s ability to earn future shared
savings and burden an ACO with debt
that they would not be able to repay.
Our experience administering the
Shared Savings Program leads us to
determine that ACOs with prior success
in the program—that is, ACOs with a
record of meeting the quality
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performance standard, not avoiding at
risk beneficiaries, and recent success in
earning shared savings—are well
positioned to identify beneficiary needs
and invest prepaid shared savings to
improve beneficiary care and are
therefore most likely to benefit from
prepaid shared savings. These ACOs
would also be reasonably confident they
will be able to repay CMS through their
earned shared savings and would
therefore be comfortable spending the
funding they receive. Accordingly, CMS
would only permit ACOs that are
currently participating in the Shared
Savings Program, that have earned
shared savings in the most recent
performance year for which financial
reconciliation has been completed, and
that have a positive prior savings
adjustment at application disposition to
receive prepaid shared savings, as they
have the history of success that provides
CMS with a more reasoned expectation
that they will earn shared savings in the
future. New ACOs would not be eligible
for prepaid shared savings, as they do
not have a recent performance history
we can use to estimate future
performance. Many new ACOs are
eligible to receive advance investment
payments, which are not available to
ACOs currently participating in the
Shared Savings Program. Advance
investment payments are more tailored
to the needs of a new ACO as there is
more flexibility in the use of funding
and advance investment payments do
not need to be repaid in the event that
the ACO does not earn shared savings.
Additionally, ACOs that did not meet
the quality performance standard as
specified under § 425.512 or were
subject to a pre-termination action from
CMS after determining an ACO avoided
at-risk beneficiaries as specified under
§ 425.316(b)(2) in the agreement period
preceding the agreement period in
which they would receive prepaid
shared savings would be prohibited
from participating in the prepaid shared
savings payment option, as these
compliance issues can prevent an ACO
from earning shared savings that would
be used to repay the prepaid shared
savings.
CMS also proposes to limit
participation in the prepaid shared
savings payment option to ACOs that
have fully repaid all shared losses they
may owe and any advance investment
payments they may have received in a
prior agreement period, and to ACOs
that participate in a two-sided risk track
(Levels C–E of the BASIC track or the
ENHANCED track), as these tracks
require a repayment mechanism in
accordance with § 425.204(f), which
could be used to recoup prepaid shared
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savings. CMS also proposes these
criteria in part to limit participation to
ACOs that are most likely to be able to
repay any prepaid shared savings they
receive. Similarly, if the ACO received
prepaid shared savings in a current or
previous agreement period, they must
have fully repaid the amount of prepaid
shared savings received though the most
recent performance year for which CMS
has completed financial reconciliation
before they would be able to renew their
participation in prepaid shared savings
for another agreement period. For
example, if an ACO is in the fifth year
of its 5-year agreement period during
which they have been receiving prepaid
shared savings and is in the process of
renewing for a new agreement period,
CMS would ensure they have fully
repaid the prepaid shared savings
received from the first four performance
years of their current agreement period
through earned shared savings before
they are approved to receive prepaid
shared savings in a new agreement
period. As CMS intends to provide
prepaid shared savings to ACOs if they
improve and maintain performance and
continue to see success in the program
on an annual basis, ACOs that are not
initially eligible would have the option
to participate in the prepaid shared
savings payment option in future years
if they demonstrate a more recent
history of success in the program and
meet the other eligibility criteria. These
criteria also provide an additional
incentive for ACOs to improve their
performance in the program. CMS
would also continue to review the
eligibility criteria over time and may
expand eligibility in future years if we
determine that doing so is in the
interests of the Shared Savings Program,
participating ACOs, and their
beneficiaries, and all requirements
under section 1899(i)(3) of the Act are
satisfied. Additionally, to standardize
timelines for payment, spending, and
recoupment of prepaid shared savings,
ACOs would only be eligible for prepaid
shared savings if they renew or early
renew to begin a new agreement period.
The proposed policies for the
calculation, spending and recoupment
of prepaid shared savings allow for up
to five years for ACOs to receive, spend
and repay the funding through earned
shared savings. We propose to create a
new paragraph in § 425.100(e) to
establish that an ACO may receive
prepaid shared savings if it meets the
criteria under § 425.640(b). We propose
in § 425.640(b) to specify the eligibility
criteria for an ACO to receive prepaid
shared savings. We seek comments on
these proposals.
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c. Application Procedure & Contents
We propose to establish the process
for an ACO to apply for prepaid shared
savings in § 425.640(c). Specifically, we
propose that an ACO must submit to
CMS supplemental application
information sufficient for CMS to
determine whether the ACO is eligible
to receive prepaid shared savings. The
application cycle for prepaid shared
savings would be conducted as part of,
and in conjunction with, the Shared
Savings Program application process
under § 425.202, with instructions and
timelines published on the Shared
Savings Program website. We propose
the initial application cycle to apply for
prepaid shared savings would be for a
January 1, 2026, start date. We intend to
provide further information regarding
the process, including the application
contents and specific requirements such
as the deadline for submitting
applications and all supplemental
application information that would be
required, through subregulatory
guidance. The prepaid shared savings
application procedure would also
include a process by which CMS
provides an applicant with feedback
and an opportunity to clarify or revise
their application.
CMS would provide preliminary
information to the applicant ACO about
its eligibility to receive prepaid shared
savings during the Phase 1 application
cycle requests for information, and a
final determination about its eligibility
to receive prepaid shared savings at the
time of final application dispositions.
For example, for ACOs applying in 2025
for an agreement period beginning in
2026, we would provide preliminary
information identifying whether an
ACO is likely to earn shared savings in
the 2024 performance year and have a
positive prior savings adjustment as
calculated per § 425.658 at application
disposition.
We propose at § 425.640(d)(1) that an
ACO would be required to submit a
spend plan as part of its application for
prepaid shared savings. We propose that
the plan must describe how the ACO
would spend the prepaid shared savings
during the first performance year of the
agreement period during which the
ACO would receive prepaid shared
savings, including the breakdown of
how the funding would be spent
consistent with the allowable uses as
described in section III.G.5.d of this
proposed rule and information about:
(1) direct beneficiary services that
would be provided to ACO
beneficiaries; and (2) investments that
would be made in the ACO with
prepaid shared savings. ACOs must also
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include their communication strategy
for informing both CMS and any
impacted beneficiaries if the ACO will
no longer be providing any direct
beneficiary services (as described in
section III.G.5.d of this proposed rule)
that had previously been provided by
the ACO using prepaid shared savings.
This communication strategy must
include when and how the ACO intends
to notify CMS and the impacted
beneficiaries as well as any available
alternatives for impacted beneficiaries
to access similar services. ACOs would
be able to limit the distribution of direct
beneficiary services to subgroups of
assigned beneficiaries including those
with specific medical conditions or
specific socioeconomic needs. ACOs
would be required to attest that they
will not discriminate on the basis of
race, color, religion, sex, national origin,
disability, or age with respect to their
use of prepaid shared savings. ACOs
would have flexibility to alter their use
of prepaid shared savings from their
submitted spend plans during each
performance year but would be required
to ensure than any changes to proposed
spending aligns with the restrictions on
spending discussed in section III.G.5.d
of this proposed rule. CMS would
review mid-year changes of the use of
prepaid shared savings at the end of
each performance year. CMS would also
be able to review an ACO’s spend plan
at any time and require the ACO to
modify its spend plan to comply with
the requirements of § 425.640(d) and (i).
As discussed in greater detail in
section III.G.5.h of this proposed rule,
we would reserve the right to withhold
or terminate an ACO’s ability to receive
the prepaid shared savings if it is not in
compliance with the requirements of the
Shared Savings Program codified in part
425 of our regulations, pursuant to
proposed § 425.640(h)(1)(i). In addition,
by certifying their application under
§ 425.202(a)(2), the ACO certifies that
the information contained in the
application, including information
related to the intended use of prepaid
shared savings, is accurate, complete,
and truthful.
We propose at § 425.640(d) that we
would review the information submitted
in the ACO’s prepaid shared savings
application to determine whether an
ACO meets the criteria for prepaid
shared savings and would approve or
deny the application accordingly. We
would review the ACO’s Shared Savings
Program renewal application
simultaneously with the prepaid shared
savings application.
As discussed in section III.G.5.g of
this proposed rule, we are also
proposing to update our public
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reporting requirements under § 425.308
by adding new paragraph (b)(10) to
require an ACO to publicly report its
spend plan. We propose to require that
the ACO post on its dedicated public
reporting web page: (1) the total amount
of prepaid shared savings received from
CMS for each performance year; (2) the
ACO’s spend plan; and (3) an
itemization of how the prepaid shared
savings were actually spent during each
performance year, including
expenditure categories, the dollar
amounts spent on the various categories,
information about which groups of
beneficiaries received direct beneficiary
services that were purchased with
prepaid shared savings and investments
that were made in the ACO with
prepaid shared savings, how these
direct beneficiary services were
provided to beneficiaries and how the
direct beneficiary services and
investments supported the care of
beneficiaries, any changes to the spend
plan as submitted under § 425.640(d)(2)
(if applicable), and such other
information as may be specified by
CMS. Additionally, we are proposing
that the ACO would be required to
report the same information to CMS
under § 425.640(i) to facilitate efficient
monitoring. This would help ensure that
CMS efficiently obtains information in a
consistent manner from all ACOs
receiving prepaid shared savings and
thereby support CMS’s monitoring and
analysis of the use of prepaid shared
savings. CMS will also make this data
publicly available through a public use
file. Further, we expect 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. We
also intend to use the information
submitted to CMS to generate a public
use file that can be used to quickly
review the use of prepaid shared savings
across all participating ACOs.
We propose to add § 425.640(c) and
(d) to establish standards for the
contents of an application to be
determined eligible for prepaid shared
savings as well as the procedures for
filing such an application. We seek
comments on these proposals.
d. Allowable and Prohibited Uses of
Prepaid Shared Savings
We propose in § 425.640(e) to specify
how an ACO may use prepaid shared
savings. Similar to advance investment
payments, prepaid shared savings are
intended to improve quality and
efficiency of items and services
furnished to Medicare beneficiaries. We
recognize that there are many ways to
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do this, and that the most effective ways
would vary by ACO. Our proposal
intends to provide ACOs with flexibility
to use payments consistent with broad
allowable uses. However, as prepaid
shared savings are only available to
ACOs that are currently successfully
participating in the Shared Savings
Program, we intend to place restrictions
on the amount of total annual prepaid
shared savings that can be spent on each
category of spending. Financially
successful ACOs are likely to have
already made significant investments in
staffing and healthcare infrastructure, as
they are necessary for the functioning of
an ACO, and we intend to encourage
ACOs receiving prepaid shared savings
to invest in direct beneficiary services
that are not already offered by the ACO.
Direct beneficiary services like vision,
hearing and dental, and other services
that have a reasonable expectation of
improving or maintaining the health or
overall function of ACO beneficiaries,
have the potential to further improve
beneficiary outcomes, reduce costs, and
improve beneficiary engagement and
willingness to receive care from a
provider affiliated with an ACO.
However, staffing and healthcare
infrastructure are still important
expenses that can have positive impacts
on healthcare costs, ACO efficiency, the
quality of beneficiary care, regardless of
an ACO’s experience in the Shared
Savings Program. Accordingly, we also
intend to allow ACOs to use some of
their prepaid shared savings to invest in
these areas. For each performance year,
ACOs would be permitted to use up to
50 percent of their estimated annual
prepaid shared savings on staffing and
healthcare infrastructure and up to 100
percent of their estimated annual
prepaid shared savings on direct
beneficiary services. ACOs must use a
minimum of 50 percent of their prepaid
shared savings on direct beneficiary
services.
We note that an ACO may use prepaid
shared savings for staffing, healthcare
infrastructure and direct beneficiary
services in a manner that complies with
the beneficiary incentives provision at
§ 425.304(a), (b), and newly proposed
(d) as discussed in section III.G.5.i of
this proposed rule, and all other
applicable laws and regulations.
Permitted uses for ‘‘staffing and
healthcare infrastructure’’ include but
are not limited to the following:
• Staffing. Examples could include,
but are not limited to, hiring physicians,
physicians’ assistants, nurse
practitioners, clinical nurse specialists,
nutrition professionals, case managers,
licensed clinical social workers,
community health workers, patient
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navigators, health equity officers,
psychiatrists, clinical psychologists,
therapists, mental health counselors,
licensed professional counselors,
substance use counselors, peer support
specialists, and other behavioral health
clinicians, or staff education.
• Healthcare Infrastructure: Examples
could include, but are not limited to,
investments in or improvements to
existing case or practice management
systems, clinical data registries,
electronic quality reporting, health
information exchange participation,
certified electronic health record
technology (CEHRT), health IT to
support behavioral health or dental
services, IT-enabled screening tools,
closed-loop referral tools, audiovisual
interpreter technology, or practice
physical accessibility improvements.
Investments can be made for individual
ACO providers/suppliers (as defined in
§ 425.20) or ACO wide.
• Direct beneficiary services include
in-kind items or services provided to an
ACO beneficiary that are not otherwise
covered by Traditional Medicare but
have a reasonable expectation of
improving or maintaining the health or
overall function of ACO beneficiaries.
Direct beneficiary services can also
include cost sharing support including
the reduction of beneficiary copay or
deductibles for Traditional Medicare
beneficiaries. In advance of the
application deadline for agreement
periods beginning on January 1, 2026,
we intend to release sub regulatory
guidance with more specific
information about permitted uses of
funding for direct beneficiary services.
Permitted uses for direct beneficiary
services could include, but are not
limited to the following: beneficiary
meals, nutrition support, tenancy
support and sustaining services,
housing assistance, utility support,
caregiver support services, services to
address social isolation, home visits,
transportation services, home or
environmental modifications like air
conditioners, bathroom safety devices,
personal emergency response systems or
medical alert systems, and vision,
hearing or dental care directly provided
by ACO providers/suppliers (as defined
in § 425.20) or covered under a health
insurance plan purchased by the ACO
on behalf of the beneficiary. While some
of these services are covered in some
form by Traditional Medicare, prepaid
shared savings funding reserved for
direct beneficiary services would only
be permitted to be used for those
services if the version of the service
offered by the ACO is not currently
covered by Traditional Medicare and
there is a reasonable expectation that
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those services will improve or maintain
the health or overall function of ACO
beneficiaries. For example, some types
of home visits are covered by
Traditional Medicare, but an ACO
would be able to extend the number of
home visits offered to beneficiaries
beyond the number covered by
Traditional Medicare with prepaid
shared savings. Direct beneficiary
services would also include cost-sharing
support, including the reduction of
beneficiary copay or deductibles for
Traditional Medicare beneficiaries for
Part B primary care services. ACOs
would be able to provide cost-sharing
support for primary care services (as
defined in § 425.20) with respect to
which coinsurance applies under Part B.
As discussed in section III.G.5.i of this
proposed rule, if this rulemaking is
finalized, CMS expects to make a
determination that the anti-kickback
statute safe harbor for CMS-sponsored
model patient incentives
(§ 1001.952(ii)(2)) is available to protect
direct beneficiary services that are made
in compliance with this policy and the
conditions for use of the antikickback
statute safe harbor set out at
§ 1001.952(ii)(2). As noted earlier in this
preamble, ACOs that wish to provide
direct beneficiary services beneficiaries
through prepaid shared savings will
need to submit a spend plan with
information including the groups of
beneficiaries they intend to provide
with direct beneficiary services, how the
direct beneficiary services will be
provided to beneficiaries and how such
services support the care of
beneficiaries, and attest that they will
not discriminate on the basis of race,
color, religion, sex, national origin,
disability, or age with respect to how
they propose to spend prepaid shared
savings. As proposed, ACOs will also be
required to report their actual use of
prepaid shared savings after the end of
each performance year, including which
groups of beneficiaries received direct
beneficiary services, how such services
were provided to beneficiaries, and how
these services supported the care of
beneficiaries.
Many direct beneficiary services may
be provided by staff working for an ACO
or its participating providers or
suppliers. If a staff member is hired or
directed to provide these services, ACOs
may use dollars designated for direct
beneficiary services to cover the
percentage of their salary that aligns
with the percentage of time the staff
member spends providing direct
beneficiary services that are not
otherwise covered by Traditional
Medicare. This funding may also be
used to contract with a community-
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based organization (CBO) or other
external entity to pay their staff to
provide direct beneficiary services.
Additionally, ACOs should take care to
ensure that a direct beneficiary service
that is provided to a beneficiary does
not impact other Federal, state, or local
means-tested benefits a beneficiary is
already receiving and should provide
beneficiaries with any necessary
documentation regarding their receipt of
the direct beneficiary service. If CMS
finalizes this proposal, we would
include additional information in our
sub regulatory guidance regarding the
approved uses for direct beneficiary
services and potential impacts on
beneficiary eligibility for other Federal
means tested programs.
We propose in § 425.640(e)(2) that an
ACO may not use prepaid shared
savings for any expense other than those
allowed under paragraph (e)(1).
Prohibited uses of prepaid shared
savings would include management
company or parent company profit,
performance bonuses, provision of
medical services covered by Traditional
Medicare, cash or cash equivalent
payments to patients, and items or
activities unrelated to the management
and operations of an ACO or care of
beneficiaries. Similar to advance
investment payments, prepaid shared
savings are intended to help an ACO put
care processes in place to directly care
for the unique needs of the ACO’s
beneficiary population, it is not
intended to solely increase profits or to
be spent on items unrelated to the
management and operations of the ACO
or the beneficiaries it serves.
Additionally, we propose that an ACO
participating in Levels C–E of the BASIC
track or the ENHANCED track may not
use any prepaid shared savings to pay
back any shared losses that it would
have incurred as specified in a written
notice from CMS under § 425.605(e)(2)
or § 425.610(h)(2), respectively.
To the extent that an ACO is
addressing unmet social needs,
including food insecurity and
transportation problems, through direct
beneficiary services, we encourage
ACOs to coordinate with a communitybased organization to provide these
services. As explained in the CY 2023
PFS proposed rule (87 FR 46102), where
we refer to CBO, 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
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services. They may receive grants from
other agencies in the U.S. Department of
Health and Human Services, including
Federal grants administered by the
Center for Disease Control and
Prevention (CDC), Administration for
Children and Families (ACF),
Administration for Community Living
(ACL), or other Federal or State funded
grants to provide social services.
Generally, such organizations know
the populations they serve and their
communities and may have the
infrastructure or systems in place to
help coordinate supportive services that
address social determinants of health or
serve as a source from which ACOs can
receive information regarding
community needs. Since CBOs have
developed such an expertise, we believe
it would be impactful for ACOs in the
delivery of high-quality direct
beneficiary services to contract with
CBOs in the provision of these services.
CMS further encourages ACOs to work
with community care hubs, which are
community-focused entities supporting
a network of CBOs that provide services
addressing health-related social needs
and centralize administrative functions
and operational infrastructure. Working
directly with a community care hub can
help connect the ACO with multiple
smaller CBOs in the provision of direct
beneficiary services. If an ACO works
with a CBO to provide these types of
services and this is reflected in its plan
to address the needs of its population,
we would consider them to be in
compliance with the requirement at
§ 425.112(b)(2)(iii)(A), which requires
an ACO to, in its plan to address the
needs of its population, describe how it
intends to partner with community
stakeholders to improve the health of its
population.
We also propose in § 425.640(f)(6) to
allow ACOs receiving prepaid shared
savings to request a smaller quarterly
payment amount from CMS. For
example, if an ACO is eligible for a
maximum quarterly prepaid shared
savings amount of one million dollars,
we would estimate their annual prepaid
shared savings to be four million
dollars. This allows the ACO to spend
up to two million dollars on staffing and
healthcare infrastructure and up to their
full $4 million payment amount on
direct beneficiary services. However, the
ACO may request a lower quarterly
payment of $500,000 that results in the
ACO only receiving two million dollars
over the full performance year. This
would also reduce the amount the ACO
can spend on staffing and healthcare
infrastructure as an ACO may not spend
more than 50 percent of the prepaid
shared savings they receive on staffing
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and healthcare infrastructure. In the
event that CMS stops or reduces an
ACOs quarterly payments during the
performance year below the quarterly
payment amount previously requested
by the ACO, the reduction does not
impact the total maximum amount they
are permitted to spend on each category
of allowable uses identified at the start
of each year, as it would not be
appropriate to subject ACOs to mid-year
spend plan changes when they may
have entered into contracting or other
arrangements with staff or suppliers
which could impact continuity of care.
We would monitor how ACOs are
spending these funds and, as necessary,
revisit these guidelines in future
rulemaking if changes are required.
We seek comment on these proposals.
e. Calculation of Prepaid Shared Savings
As noted in section III.G.5.a of this
proposed rule, we have determined that
prepaid shared savings would not result
in additional program expenditures.
While ACOs would be required to repay
the prepaid shared savings they receive
through earned shared savings, it is also
important for CMS to avoid paying
ACOs an amount of prepaid shared
savings that they are unlikely to be able
to repay through earned shared savings.
While prepaid shared savings would be
helpful in providing successful ACOs
with additional cash flow that would
encourage their investment in activities
that could potentially reduce ACOs’
costs and improve the quality of care
that ACOs provide to their beneficiaries,
overpaying ACOs might result in a level
of outstanding debt for some ACOs that
could disrupt their operations and
potentially their participation in the
Shared Savings Program as well as
generate unnecessary financial risk for
CMS. Our proposed policies on the
calculation and distribution of the
prepaid shared savings payments are
intended to balance the benefit for the
ACOs of receiving funding earlier with
the risk of overpayment both for CMS
and the ACO, while helping to ensure
that prepaid shared savings do not
result in additional program
expenditures.
We are proposing a new § 425.640(f)
to provide an ACO that CMS determines
meets the eligibility criteria described in
section III.G.5.b of this proposed rule
with a prepaid shared savings payment
for each quarter of an agreement period
that they are determined to be eligible
for prepaid shared savings equal to the
maximum quarterly payment amount
calculated pursuant to the methodology
outlined in § 425.640(f)(2) (as further
explained elsewhere in this section), the
ACO elects to receive a lesser amount as
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described in § 425.640(f)(6) (as further
explained in section III.G.5.d. of this
proposed rule) or the payment is
withheld or terminated pursuant to
§ 425.640(h). If an ACO’s quarterly
payment is withheld or terminated (as
further explained in section III.G.5.f.(2)
of this proposed rule), we would not
provide ACOs with additional or catchup payments if quarterly payments of
prepaid shared savings are later
resumed. We propose that under new
§ 425.640(f), CMS would notify in
writing each ACO of its determination
of the amount of prepaid shared savings.
The notice would inform the ACO of its
right to request reconsideration review
in accordance with the procedures
specified in subpart I of our regulations.
If CMS does not make any prepaid
shared savings payment, the notice
would specify the reason(s) why and
inform the ACO of its right to request
reconsideration review in accordance
with the standards specified in subpart
I of our regulations. Thus, prior to each
quarterly payment, we propose to
provide the ACO with the notice
described above in the form of a report
that shows our calculation of the ACO’s
quarterly prepaid shared savings
amount. We propose to coincide the
timing of these notices with the timing
of existing report packages sent to ACOs
for informational purposes, in December
(after initial assignment prior to a given
performance year), May (after quarter 1
assignment for a given performance
year), and August (after quarter 2
assignment for a given performance
year). Accordingly, notice regarding the
first and second quarterly payments that
an eligible ACO would receive in a
given performance year would be
provided in December of the
immediately preceding year.
Subsequent notices regarding the third
and fourth quarterly payments that an
eligible ACO would receive in a given
performance year would then be
provided in May and August,
respectively, of that performance year.
We are also proposing a new
§ 425.640(f)(2) to specify the calculation
of an ACO’s maximum quarterly
prepaid shared savings payment. To
calculate this payment, we propose
calculating a prepaid shared savings
multiplier, adjusting it by several factors
explained later in this section, and then
multiplying one-fourth of the adjusted
multiplier by an ACO’s assigned
beneficiary person years. We propose to
calculate the prepaid shared savings
multiplier as the simple average of per
capita savings or losses generated by the
ACO during the two most recent
performance years that have been
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financially reconciled at the time of the
ACO’s renewal application disposition,
which constitute benchmark year (BY) 1
and BY2 of the agreement period in
which the ACO may receive prepaid
shared savings (‘‘current agreement
period,’’ hereafter). That is, we would
exclude BY3 from the calculation of an
ACO’s average per capita savings or
losses because the performance year that
constitutes BY3 of the ACO’s current
agreement period would not have been
financially reconciled at the time of the
ACO’s application disposition.
Accordingly, the per capita savings for
each performance year would be
determined as the quotient of the ACO’s
total updated benchmark expenditures
minus total performance year
expenditures divided by performance
year assigned beneficiary person years.
For purposes of calculating the simple
average of per capita savings or losses
generated by the ACO during the two
most recent performance years that have
been financially reconciled, we would
use all savings generated during each of
the 2 performance years in the prepaid
shared savings multiplier, not just
savings that met or exceeded the ACO’s
minimum savings rate (MSR) for that
prior performance year.
Under new § 425.640(f)(2)(iii), we
propose to apply a proration factor to
the prepaid shared savings multiplier to
account for situations where an ACO’s
assigned beneficiary population is larger
in BY1 and BY2 when calculated using
the ACO’s certified ACO participant list
and assignment methodology for a given
performance year within the current
agreement period, as compared to the
ACO’s assigned beneficiary population
when the ACO was reconciled for the
performance years that constitute BY1
and BY2 of the current agreement
period. Mathematically, to apply this
proration factor we would calculate the
ratio between: (1) the ACO’s average
assigned beneficiary person years for the
2 performance years that constitute BY1
and BY2 for the ACO’s current
agreement period (regardless of whether
these performance years occurred over
one or multiple prior agreement periods,
which would occur if the ACO early
renews immediately before the current
agreement period) and (2) the average
assigned beneficiary person years in
BY1 and BY2 for the ACO’s current
agreement period calculated using the
ACO’s certified ACO participant list and
assignment methodology for a given
performance year within the current
agreement period. Increases in the size
of the ACO’s assigned beneficiary
population during the current
agreement period would therefore result
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in a ratio less than 1, while decreases in
the assigned beneficiary population
would result in a ratio greater than 1.
This ratio would be capped at 1 to avoid
increasing the adjusted prepaid shared
savings multiplier if the average number
of beneficiaries assigned to the ACO
across the 2 benchmark years of its
current agreement period is lower than
the average number of beneficiaries
assigned during the 2 performance years
that constitute BY1 and BY2. Prorating
for growth in assignment would ensure
that the prepaid shared savings amount
does not exceed the amount of
cumulative savings generated by the
ACO during the performance years that
constitute BY1 and BY2 for its current
agreement period.
It is necessary to calculate a proration
factor at the start of the ACO’s current
agreement period to account for several
possible circumstances in which the
ACO’s assigned beneficiary population
may be different in BY1 and BY2 when
calculated using the ACO’s certified
ACO participant list and assignment
methodology for a given performance
year within the current agreement
period, as compared to the ACO’s
assigned beneficiary population when
the ACO was reconciled for the
performance years that constitute BY1
and BY2 of the current agreement
period. Specifically, changes in the size
of the ACO’s assigned beneficiary
population at the start of the ACO’s
current agreement period could be 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), or changes to the
beneficiary assignment methodology
specified in 42 CFR part 425, subpart E.
Additionally, these circumstances
could potentially arise after the start of
the ACO’s current agreement period. In
turn, changes in the size of the ACO’s
assigned beneficiary population could
potentially occur throughout the course
of the current agreement period.
Therefore, we propose in new
§ 425.640(f)(3)(ii) that for the second
and each subsequent performance year
during the term of the current agreement
period, we would redetermine this
proration factor.
In addition to pro-rating the prepaid
shared savings multiplier, we also
propose to adjust it in two ways. First,
under new § 425.640(f)(2)(iv), we would
apply a sharing rate scaling factor of 1⁄2
(or 50 percent). This sharing rate scaling
factor would be similar to the scaling
factor we apply under § 425.658(c)(1)(i)
when calculating the prior savings
adjustment, applicable to agreement
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periods beginning on or after January 1,
2024, as finalized in the CY 2023 final
rule (refer to 87 FR 69899 through
69915). As with the prior savings
adjustment calculation, it is 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 the
agreement period immediately before it
would receive prepaid shared savings.
Consistent with the prior savings
adjustment scaling factor, 50 percent
represents an appropriate multiplier in
this context 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.
Second, under new
§ 425.640(f)(2)(v)(A), we would apply a
financial risk scaling factor equal to 2⁄3.
The purpose of the financial risk scaling
factor would be to mitigate financial risk
to the Medicare Trust Funds and to
ACOs by reducing the possibility that an
ACO’s prepaid shared savings payments
exceed the ACO’s actual earned shared
savings. The rationale for a financial
risk scaling factor of this magnitude is
that it enables us to account for a
scenario in which an ACO earned zero
per capita savings in the performance
year that constitutes BY3 of the current
agreement period, which is necessarily
excluded from the calculation of an
ACO’s average per capita savings or
losses for purposes of the prepaid
shared savings multiplier because, as
mentioned previously, the performance
year that constitutes BY3 of the ACO’s
current agreement period would not
have been financially reconciled at the
time of the ACO’s application
disposition. Thus, by multiplying an
ACO’s average per capita savings or
losses across BY1 and BY2 by a
financial risk scaling factor equal to 2⁄3,
we are imposing a downward reduction
on the prepaid shared savings multiplier
by assuming that it would have been
possible, in principle, for an ACO to
have not earned any per capita savings
in the performance year that constitutes
BY3 of the current agreement period. By
doing so, we are reducing the
probability of distributing excessive
prepaid shared savings. As discussed
previously, it is important to avoid
distribution of excessive prepaid shared
savings because doing so could result in
several undesirable outcomes, such as
ACOs accruing debt to CMS that they
are unable to repay, which could
disruption the ACOs’ operations and
participation in the Shared Savings
Program.
Consistent with calculations of the
prior savings adjustment (refer to
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§ 425.658), the positive regional
adjustment (refer to § 425.656), and the
proposed health equity benchmark
adjustment (refer to section III.G.7.b of
this proposed rule), we propose under
new § 425.640(f)(2)(v)(B), to cap the prorated, adjusted prepaid shared savings
multiplier at 5 percent of national per
capita FFS expenditures for Parts A and
B services in order to ensure that the
amount of prepaid shared savings that
an ACO receives does not exceed an
amount that the ACO is able to repay
through earned shared savings.
Specifically, we propose to calculate the
cap as 5 percent of national per capita
FFS expenditures for Parts A and B
services in BY2 for assignable
beneficiaries identified for the 12-month
calendar year corresponding to BY2.
Consequently, under new
§ 425.640(f)(2)(v), the pro-rated,
adjusted, and capped prepaid shared
savings multiplier that would ultimately
be used to calculate a given maximum
quarterly prepaid shared savings
payment would be equal to the lesser of
(A) the pro-rated, adjusted prepaid
shared savings multiplier or (B) 5
percent of national per capita FFS
expenditures for Parts A and B services
in BY2 for assignable beneficiaries.
To calculate a given maximum
quarterly prepaid shared savings
payment, we propose under new
§ 425.640(f)(4), to multiply one-fourth of
the pro-rated, adjusted, and capped
prepaid shared savings multiplier (to
account for four quarterly payments) by
the ACO’s assigned beneficiary person
years for the latest available assignment
list for a given performance year within
the current agreement period. Varying
the maximum quarterly payment to
reflect the latest available assigned
beneficiary person years is similar to
how we calculate the AIP quarterly
payment calculation (refer to
§ 425.630(f), CY 2023 PFS final rule (87
FR 69797)), for which we use the latest
available assignment list to calculate the
quarterly advance investment payment
amount. We propose to use the latest
available beneficiary assigned person
years for the maximum quarterly
prepaid shared savings payment
because an ACO’s assigned beneficiary
person years change over the course of
a performance year and over the course
of an agreement period. Because later
assignment lists more closely reflect the
final assignment list that would be used
for calculating shared savings and losses
for a given performance year within the
current agreement period, later
assignment lists are more likely than
earlier assignment lists to facilitate
calculation of quarterly prepaid shared
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savings payment amounts that closely
align with the earned shared savings or
losses that an ACO actually generates in
the contemporaneous performance year.
Using the latest available assigned
beneficiary person years mitigates a
financial risk that an ACO experiencing
declining person years over the course
of a performance year could receive
excessive prepaid shared savings. As
mentioned previously, overpaying
prepaid shared savings could result in
ACOs accruing a level of debt to CMS
that they are unable to repay through
earned shared savings which could, in
turn, disrupt ACOs’ operations and
participation in the Shared Savings
Program.
We propose to use assigned
beneficiary person year values that CMS
provides to ACOs in annual and
quarterly informational reports. For
ACOs under preliminary prospective
assignment with retrospective
reconciliation, Medicare assigns
beneficiaries in a preliminary manner at
the beginning of a performance year
based on the most recent data available
(§ 425.400(a)(2)(i)). Assignment is
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
(§ 425.400(a)(2)(ii)). ACOs under
preliminary prospective assignment
with retrospective reconciliation receive
an assigned beneficiary person years
value based on the most recent 12 or 24
months of data, as applicable, in annual
and quarterly informational reports. For
ACOs under prospective assignment,
Medicare FFS beneficiaries are
prospectively assigned to an ACO at the
beginning of each benchmark or
performance year based on the
beneficiary’s use of primary care
services in the most recent 12 or 24
months, as applicable, for which data
are available, using the assignment
methodology described in §§ 425.402
and 425.404 (§ 425.400(a)(3)(i)). Each
quarter, CMS excludes any
prospectively assigned beneficiaries that
meet the exclusion criteria under
§ 425.401(b). ACOs under prospective
assignment receive a year-to-date
assigned beneficiary person years value
with each quarterly report package. For
ACOs under prospective assignment, we
would annualize the quarterly year-todate assigned beneficiary person years
values for use in the maximum quarterly
prepaid shared savings payment
calculation. For example, a year-to-date
person years value of 1,500 with quarter
1 informational reports would be
annualized by multiplying 1,500 by 4. A
year-to-date person years value of 3,000
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with quarter 2 information reports
would be annualized by multiplying
3,000 by 2.
We further propose to account for
circumstances when an ACO was not
reconciled for the performance year that
constitutes BY1 in the calculation of
average per capita prior savings and the
proration factor. For instance, ACOs that
renew their agreement periods early or
are re-entering may not be reconciled for
one or more of the years preceding the
start of their current agreement period
depending upon the timing of the
expiration or termination of their prior
agreement period and the start of their
current agreement period. We propose
under new § 425.640(f)(2)(i), that if an
ACO was not reconciled during one of
the 2 performance years that constitute
BY1 or BY2 of its current agreement
period, the ACO would receive zero
savings or losses for the BY
corresponding to the performance year
that was not financially reconciled in
the calculation of the prepaid shared
savings multiplier. CMS has no way to
determine whether the ACO would have
generated savings or losses during a
performance year for which it was not
reconciled. We believe this is
appropriate because it enables us to
obtain a more conservative prediction of
the ACO’s financial performance for a
given performance year within the
current agreement period than we
would be able to obtain if we were to
exclude the BY corresponding to the
performance year that was not
financially reconciled from the
calculation of the prepaid shared
savings multiplier. Excluding this year
entirely from the calculation of average
per capita prior savings would unduly
increase the weight on the other year
included in the prepaid shared savings
multiplier calculation. This would be
problematic in a case where the ACO’s
financial performance in the BY
corresponding to the performance year
that was financially reconciled is
atypically high because it would
upwardly bias the prediction of the
ACO’s financial performance for a given
performance year within the current
agreement period. Thus, by imputing
zero savings or losses for a BY
corresponding to a performance year
that was not financially reconciled in
the calculation of the prepaid shared
savings multiplier, we are reducing the
probability of overpredicting the
financial performance of the ACO for a
given performance year within the
current agreement period and, in turn,
the probability of distributing excessive
prepaid shared savings. As mentioned
previously, excessive distribution of
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prepaid shared savings could result in
several undesirable outcomes, such as
ACOs accruing debt to CMS that they
are unable to repay, which could
disrupt the ACOs’ operations and
participation in the Shared Savings
Program.
In contrast, we determined that it
would also be appropriate to exclude a
year for which the ACO was not
reconciled when calculating the
proration factor. The purpose of the
proration factor is to account for
situations where an ACO’s assigned
beneficiary population calculated at
financial reconciliation for the 2
performance years that constitute BY1
and BY2 of the ACO’s current agreement
period (numerator) is smaller than the
ACO’s assigned beneficiary population
identified for those same years using the
ACO’s certified ACO participant list and
assignment methodology for a given
performance year within the current
agreement period (denominator). If an
ACO was not reconciled for one of the
2 performance years that constitute BY1
and BY2 of the current agreement
period, it would naturally have zero
assigned beneficiary person years
determined at financial reconciliation
for such year, which would factor into
the numerator of the proration factor if
such year was considered. However, the
ACO would have positive beneficiary
counts in the 2 performance years that
constitute BY1 and BY2 of the current
agreement period generated using the
ACO’s certified ACO participant list and
assignment methodology for a given
performance year within the current
agreement period, which would factor
into the denominator of the proration
factor if such year was considered.
Thus, if the numerator and the
denominator were both calculated as
averages over 2 years, incorporating a
year for which the ACO was not
reconciled in the calculation of the
proration factor would artificially
decrease the proration factor and lead to
a smaller pro-rated average per capita
prior savings for the ACO. Alternatively,
if the numerator were calculated in a
manner that excludes a performance
year for which the ACO was not
reconciled (that is, calculated in a
manner that includes only the year for
which the ACO was reconciled from
among the 2 performance years that
constitute BY1 and BY2 of the current
agreement period) and the denominator
was calculated as an average that
included both of the 2 performance
years that constitute BY1 and BY2 of the
current agreement period, then the
direction of the impact on the proration
factor would depend on whether the
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number of assigned beneficiaries
calculated using an ACO’s current
certified ACO participant list and
assignment methodology in the
benchmark year for which the ACO was
not reconciled exceeds the number of
assigned beneficiaries in the other
benchmark year, and by how much.
Therefore, we see no compelling reason
to include a performance year
immediately preceding the start of an
ACO’s current agreement period for
which the ACO was not reconciled in
the numerator or the denominator of the
proration factor. Excluding such a year
would ensure that the proration factor
compares average person years
determined for prior performance years
at financial reconciliation (numerator)
to average person years for those
performance years determined using the
ACO’s current certified ACO participant
list and assignment methodology
(denominator) across a consistent set of
years preceding the start of the ACO’s
current agreement period.
We also propose to account for certain
circumstances where there could be
changes to the values used in
calculating the prepaid shared savings
multiplier as a result of issuance of a
revised initial determination of financial
performance under § 425.315.
To account for these situations and for
the need to recalculate the proration
factor as described elsewhere in this
section, we propose to specify in new
§ 425.640(f)(3) when CMS would
recalculate the prepaid shared savings
multiplier during the current agreement
period. For the first performance year in
the current agreement period, the ACO’s
prepaid shared savings multiplier
would be recalculated for changes in per
capita shared savings or losses for the
performance years that constitute BY1
or BY2 and that are used in the
calculation of the prepaid shared
savings multiplier 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 current agreement period,
the ACO’s prepaid shared savings
multiplier would be recalculated due to
redetermining the proration factor 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, and
for changes in per capita shared savings
or losses for the performance years that
constitute BY1 or BY2 and that are used
in the calculation of the prepaid shared
savings multiplier as a result of issuance
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of a revised initial determination under
§ 425.315.
The specific computations involved
in arriving at the maximum prepaid
shared savings payment amount for a
given ACO in a given quarter are
described below.
• Step 1: Calculate a prepaid shared
savings multiplier as the average per
capita savings across the performance
years that constitute BY1 and BY2 of the
ACO’s current agreement period. First,
calculate the total per capita savings
amount for each applicable performance
year by subtracting assigned beneficiary
expenditures from total benchmark
expenditures and divide the difference
by assigned beneficiary person years.
Then, sum the resulting quotients and
divide by 2. The per capita savings or
losses would be set to zero for a
performance year if the ACO was not
reconciled for the performance year.
• Step 2: Apply a proration factor to
the prepaid shared savings multiplier
calculated in Step 1. The proration
factor is equal to the ratio of the ACO’s
average assigned beneficiary person
years for the 2 performance years that
constitute BY1 and BY2 for the ACO’s
current agreement period (regardless of
whether these performance years
occurred over one or multiple prior
agreement periods) and the ACO’s
average assigned beneficiary person
years in BY1 and BY2 for the ACO’s
current agreement period calculated
using the ACO’s certified ACO
participant list and assignment
methodology for a given performance
year within the current agreement
period, capped at one. If the ACO was
not reconciled for the performance year
that constitutes BY1, the person years
from that year (or years) would be
excluded from the averages in the
numerator and the denominator of this
ratio. This ratio would 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 under § 425.226(a)(1), or
changes to the beneficiary assignment
methodology specified in 42 CFR part
425, subpart E.
• Step 3: Adjust the pro-rated prepaid
shared savings multiplier calculated in
Step 2. First, apply a shared savings
scaling factor by multiplying the prorated prepaid shared savings multiplier
by 0.50. Then, multiply the resulting
value by 2⁄3 to apply a financial risk
scaling factor.
• Step 4: Cap the pro-rated, adjusted
prepaid shared savings multiplier at 5
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percent of national per capita FFS
expenditures for Parts A and B services
in BY2 for assignable beneficiaries
identified for the 12-month calendar
year corresponding to BY2.
• Step 5: Multiply one-fourth of the
pro-rated, adjusted, and capped prepaid
shared savings multiplier by the
assigned beneficiary person years
derived from the ACO’s latest available
assignment list. The resulting product
would serve as the ACO’s total
maximum prepaid shared savings
payment for the applicable quarter. As
discussed previously, an ACO’s latest
available assignment list is updated
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quarterly. For ACOs under preliminary
prospective assignment with
retrospective reconciliation, assignment
is 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
(§ 425.400(a)(2)(ii)). For ACOs under
prospective assignment, assignment is
updated quarterly to exclude any
prospectively assigned beneficiaries that
meet the exclusion criteria under
§ 425.401(b) (§ 425.401(b)). Thus,
consistent with the methodology that
we apply in the case of advance
investment payments, quarterly
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variations in an ACO’s assignment list
would translate to variations in the
maximum quarterly total prepaid shared
savings payments that an ACO may
receive in any given quarter, in order to
help ensure that the payments
accurately reflect the attributes of the
ACO’s assigned beneficiary population
throughout the current agreement
period.
Table 37 presents a hypothetical
example to demonstrate how the
prepaid shared savings calculation
would work in practice.
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TABLE 37: Calculation of Maximum Quarterly Prepaid Shared Savings Payment
Step 1: Calculate
prepaid shared
savings multiplier
Per capita savings generated in the two performance years that constitute BY 1 and BY2
for the ACO's current agreement period beginning January 1, 2022
PY 2019: $350
PY 2020: $400
Multiplier: Simple average of the per capita savings across BYl and BY2
($350 + $400) / 2 = $375
Step 2: Pro-rate
the prepaid shared
savings multiplier
Assigned person years from the performance years that constitute BY I and BY2 for the
ACO's current agreement period beginning January 1, 2022:
PY 2019: 6,000
PY 2020: 7,000
Assigned person years for BYl and BY2 of current agreement period (determined using
certified ACO participant list for the current performance year of PY 2022):
BY 2019: 8,000
BY 2020: 7,500
Proration factor: Ratio between the ACO's average person years in the performance years
that constitute BYI and BY2 and the average person years in BYl and BY2, excluding
years for which the ACO was not reconciled, capped at 1.
Step 5: Determine
the maximum
prepaid shared
savings payments
for the applicable
quarter
Apply the shared savings scaling factor and the financial risk scaling factor to the prorated prepaid shared savings multiplier: $314.52 x (0.5) x (2/3) = $104.84
National assignable per capita FFS expenditures for assignable beneficiaries in BY2:
$10,000
Cap: 5 percent of national assignable per capita FFS expenditures for assignable
beneficiaries in BY2
0.05 * $10,000 = $500
Assigned beneficiary person years derived from the ACO's latest available assignment
list: 8,500.
Total prepaid shared savings payments for the applicable quarter: Product of one-fourth of
the pro-rated, adjusted, capped prepaid shared savings multiplier and the assigned
beneficiary person years derived from the ACO's latest available assignment list.
($104.84/4) X 8,500 = $222,785
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The ACO’s maximum quarterly
prepaid shared savings payments would
set a ceiling on the amount of quarterly
prepaid shared savings that an ACO
could receive from CMS for each
quarter. ACOs will be able to request to
receive an amount of funding under this
maximum amount. Prior to each
performance year, ACOs would notify
CMS of the amount of prepaid shared
savings they want to receive in the first
quarter under the maximum quarterly
prepaid shared savings amount and the
first quarterly payment will be used to
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determine the total amount of prepaid
shared savings the ACO will use to
budget for that performance year. We
are proposing in new § 425.640(f)(5) that
for the purposes of determining the
amount of prepaid shared savings
permitted to be allocated to the uses
specified in § 425.640(e), the estimated
annual prepaid shared savings amount
can be calculated by multiplying the
first quarterly payment amount the ACO
would receive in each performance year
by four. This allows the ACO to
calculate the total amount of funding
they are permitted to spend on each
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allowable use at the start of each
performance year. If an ACO’s
maximum quarterly payments decrease
over the performance year and result in
the ACO receiving less than the
estimated annual prepaid shared
savings amount, the ACO would not be
subject to compliance actions solely
because it spent more than 50 percent
of the actual annual amount of prepaid
shared savings it received during that
PY on staffing and healthcare
infrastructure, as long as it did not
spend more than 50 percent of the
originally estimated annual prepaid
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Step 3: Adjust the
pro-rated prepaid
shared savings
multiplier for
financial risk and
sharing rate
Step 4: Cap the
pro-rated,
adjusted prepaid
shared savings
multiplier
Apply the proration factor to the prepaid shared savings multiplier: [(6,000 + 7,000)/2] /
f(8,000 + 7,500)121 X $375 = $314.52
Shared savings scaling factor: (0.5)
Financial risk scaling factor: (2/3)
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shared savings amount on staffing and
healthcare infrastructure. For example,
if an ACO is eligible for a maximum
quarterly prepaid shared savings
payment of $300,000 for quarter 1 of a
performance year, but only wishes to
receive $250,000 for quarter 1 of a
performance year, their estimated
annual prepaid shared savings amount
would be $1,000,000. This allows the
ACO to spend up to $500,000 on staffing
and healthcare infrastructure, or up to
the full amount of $1,000,000 on direct
beneficiary services. If an ACO has a
reduction in assigned beneficiaries and
is only eligible for a maximum quarterly
prepaid shared savings payment of
$200,000 for quarters 2, 3 and 4, this
results in an actual total of $850,000 in
received prepaid shared savings for the
performance year. However, the ACO
would still be permitted to spend up to
$500,000 on staffing and healthcare
infrastructure in that performance year,
as that is 50 percent of the original
estimated amount and we do not want
to change budget maximums
retroactively for an ACO.
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f. Duration, Frequency and Withholding
or Termination of Prepaid Shared
Savings Payments
(1) Duration and Frequency
CMS anticipates that the vast majority
of ACOs receiving prepaid shared
savings would fully repay the amount
they receive of prepaid shared savings
from their earned shared savings on an
annual basis. This would allow CMS to
distribute prepaid shared savings to
ACOs continually, throughout an
agreement period in which the ACO is
deemed eligible to participate, without
withholding prepaid shared savings
pursuant to § 425.640(h). We are
proposing at § 425.640(f)(1) that ACOs
would receive quarterly prepaid shared
savings payments for the entirety of the
ACO’s agreement period unless
withheld or terminated pursuant to
§ 425.640(h). However, we are also
proposing at § 425.640(h)(3) that if CMS
withholds or terminates a quarterly
payment pursuant to paragraph (h), the
ACO would not receive additional or
catch-up payments if quarterly prepaid
shared savings payments are later
resumed. As discussed later in this
section, prepaid shared savings
payments would generally be withheld
from ACOs when CMS has information
that the ACO may not generate
sufficient earned shared savings to
repay the prepaid shared savings in
current or future performance years or
has other Shared Savings Program
compliance issues. Once prepaid shared
savings payments are withheld, if an
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ACO earns shared savings in a future
year, then prepaid shared savings can
resume at the time of the next scheduled
quarterly payment, but catch-up
payments would not be provided. This
protects CMS from distributing
payments that the ACOs may not be able
to repay and the ACOs from
accumulating more debt than they can
repay through earned shared savings.
An ACO would be notified if CMS is
willing to resume prepaid shared
savings payments, and would have the
ability to elect to resume payments as
well as select the payment amount they
would like to receive under the
maximum quarterly payment, if desired.
(2) Withholding and Termination
In order to ensure orderly
administration of the Shared Savings
Program, including protection of the
Medicare Trust Funds, we intend to
monitor the performance of ACOs
receiving prepaid shared savings and
propose that we may withhold or
terminate quarterly prepaid shared
savings payments under a variety of
specified circumstances. Many of the
circumstances under which we propose
that CMS may withhold to terminate the
payments directly relate to
circumstances under which CMS would
be concerned that the ACO has not or
will not meet the standards for the use
prepaid shared savings, such as an
ACO’s failure to comply with the
requirements of proposed § 425.640.
Other circumstances would address
situations where it becomes apparent
that the ACO’s is likely to lack the
ability to repay prepaid shared savings
to CMS. For example, we propose that
CMS may withhold or terminate the
payments if CMS predicts that the ACO
will not generate sufficient earned
shared savings to repay the prepaid
shared savings in future performance
years or has other Shared Savings
Program compliance issues. These
predictions would be based on a rolling
12-month window of beneficiary claims
data or year-to-date beneficiary claims
data, depending on whether an ACO
selects prospective Assignment or
preliminary prospective assignment
with retrospective reconciliation. We
propose that CMS may also withhold
quarterly payments if an ACO fails to
earn enough shared savings in a
performance year to fully repay the
prepaid shared savings the ACO
received during that performance year,
in order to avoid the ACO accruing debt
they would be unable to repay. As noted
earlier in this section, an ACO would be
notified if CMS determines the ACO is
sufficiently likely to earn additional
shared savings such that CMS could
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resume prepaid shared savings
payments, in which case the ACO
would have the ability to elect to
resume payments and select the
payment amount they would like to
receive. Additionally, while unspent
funds received for a performance year
must be reallocated in the spend plan
for the ACO’s next performance year as
noted in § 425.640(e)(3), if an ACO fails
to spend a majority of the prepaid
shared savings they receive in a
performance year, CMS may withhold
future quarterly payments until the ACO
spends the funding they have already
received and reports this spending to
CMS through an updated spend plan.
An ACO may also request that CMS
withhold their future quarterly
payments until the ACO is ready for
payments to resume. ACOs that elect to
have CMS withhold their prepaid
shared savings payments would have
the ability to later elect to resume
payments as well as select the payment
amount they would like to receive. If an
ACO has unspent funding at the end of
their agreement period, that funding
must be repaid to CMS pursuant to
proposed § 425.640(e)(3).
Accordingly, we propose at
§ 425.640(h)(1) that CMS may withhold
or terminate prepaid shared savings
during an agreement period if:
• The ACO fails to comply with any
of the prepaid shared savings
requirements of § 425.640;
• The ACO meets any of the grounds
for ACO termination set forth in
§ 425.218(b); 498
• The ACO fails to earn sufficient
shared savings from a performance year
to repay the prepaid shared savings they
received during that performance year;
• CMS determines that the ACO is
not expected to earn shared savings in
a performance year during the
agreement period in which the ACO
received prepaid shared savings, based
on a rolling 12-month window of
beneficiary claims data or year-to-date
beneficiary claims data;
• The ACO falls below 5,000 assigned
beneficiaries;
• The ACO fails to spend the majority
of prepaid shared savings they receive
in a performance year; or
• The ACO requests that CMS
withhold a future quarterly payment
Additionally, we propose at
§ 425.640(h)(2) that CMS must terminate
an ACO’s prepaid shared savings during
an agreement period if:
498 Under §§ 425.216 and 425.218, CMS can
terminate an ACO’s participation agreement or take
pre-termination actions (such as requesting a
corrective action plan) if CMS determines that an
ACO is not in compliance with the requirements of
Part 425 of our regulations.
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• The ACO fails to maintain an
adequate repayment mechanism in
accordance with § 425.204(f); or
• The ACO fails to meet the quality
performance standard as specified
under § 425.512 or is subject to a pretermination action after CMS
determined the ACO avoided at-risk
beneficiaries as specified under
§ 425.316(b)(2).
We further propose under
§ 425.640(h)(4) that CMS may
immediately terminate an ACO’s
prepaid shared savings under
§ 425.640(h)(1) and (2) without taking
any of the pre-termination actions set
forth in § 425.216.
In general, if an ACO is complying
with the Shared Savings Program and
prepaid shared savings requirements but
is not achieving, or is not predicted to
achieve, success in earning shared
savings, CMS may withhold payments
while the ACO works to improve their
financial performance. For example, if
an ACO is eligible to receive quarterly
prepaid shared savings payments in an
agreement period beginning in 2026 but
does not earn shared savings during
2025 reconciliation that occurs in mid2026, the ACO’s quarterly payments
would be withheld until the ACO earns
shared savings in a future performance
year reconciliation. Similar to our
rationale for the eligibility requirement
described at § 425.640(b)(2), we believe
that recent past performance in earning
shared savings provides information on
the ACO’s potential to earn future
shared savings, and we would not
distribute prepaid shared savings to
ACOs that have not earned sufficient
shared savings in their most recent
reconciled performance year to repay
the prepaid shared savings they
received during that performance year.
Additionally, if CMS, through its
financial monitoring of ACOs, predicts
that an ACO would not earn shared
savings in its current performance year,
quarterly prepaid shared savings may be
withheld until the ACO generates
earned shared savings in the future. We
expect that immediate termination of
prepaid shared savings during an
agreement period, without a possibility
of resumption of payments during that
agreement period, would be invoked
only in cases of serious noncompliance
with the requirements of § 425.640,
including deliberately spending prepaid
shared savings on a prohibited use, or
when the ACO’s actions or inaction
poses a risk of harm to beneficiaries or
negatively affects their access to care.
We seek comment on these proposals.
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g. Monitoring ACO Eligibility for and
Use of Prepaid Shared Savings
To provide CMS with a clear
indication of how ACOs intend to spend
prepaid shared savings, help provide
adequate protection to the Medicare
Trust Funds, and prevent funds from
being misdirected or appropriated for
activities that do not fall within the
parameters set forth within proposed
§ 425.640(e), we propose in
§ 425.316(f)(1) to monitor ACOs
receiving prepaid shared savings for
compliance with § 425.640(e) and to
determine whether it would be
appropriate to withhold or terminate an
ACO’s prepaid shared savings under
§ 425.640(h)(1) and (h)(2). For the first
performance year of the current
agreement period, we would monitor
the ACO’s use of prepaid shared savings
by comparing the anticipated spending
as set forth in the spend plan submitted
with an ACO’s application against the
actual spending as reported by the ACO,
including any expenditures not
identified in the spend plan. ACOs
would be required to submit a revised
spend plan with updated anticipated
spending annually, as well as annually
report their actual expenditures to CMS
and on their public reporting web page
as noted in §§ 425.308(b)(10) and
425.640(i), and we would similarly
monitor the ACO’s use of prepaid
shared savings during the current
agreement period using the updated
spend plan and those reports. The
reported annual spending must include
any expenditures of prepaid shared
savings on items not identified in the
spend plan. In the event that an ACO
uses prepaid shared savings for uses not
permitted by § 425.640(e), CMS would
require them to reallocate the funding to
a permitted use and may take
compliance action as specified in
§§ 425.216, 425.218 or withhold or
terminate payments as specified in
proposed § 425.640(h)(1).
Similar to the policy for advance
investment payments (§ 425.630), we
additionally believe that transparency of
information in the healthcare sector
facilitates more informed patient choice
and offers incentives and feedback that
help improve the quality and lower the
cost of care and improve oversight with
respect to program integrity. As CMS
has discussed in previous final rules,
improved transparency supports a
number of program requirements. In
particular, increased transparency is
consistent with and supports the
requirement under section 1899(b)(2)(A)
of the Act for an ACO to be willing to
‘‘become accountable for the quality,
cost, and overall care’’ of the Medicare
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beneficiaries assigned to it. Therefore,
we believe it is desirable and consistent
with section 1899(b)(2)(A) of the Act for
several aspects of an ACO’s use of
prepaid shared savings to be available to
the public. Making this information
available would provide both Medicare
beneficiaries and the general public
with insight into the use of prepaid
shared savings by an ACO.
Accordingly, we are proposing to
modify § 425.308 to require that an ACO
publicly report information annually
regarding prepaid shared savings on its
public reporting web page. Specifically,
under proposed new § 425.308(b)(10),
we are proposing that, for each
performance year, an ACO would be
required to report (in a standardized
format specified by CMS) its spend plan
for each performance year, the total
amount of prepaid shared savings
received, and an itemization of how any
prepaid shared savings were actually
spent during each year, including
expenditure categories, the dollar
amounts spent on the various categories,
information about which beneficiaries
received direct beneficiary services that
were purchased with prepaid shared
savings and investments that were made
in the ACO with prepaid shared savings,
any changes to the spend plan as
submitted under § 425.640(d)(1), and
such other information as may be
specified by CMS. We propose that this
itemization would include expenditures
not identified or anticipated in the
ACO’s submitted spend plan, and any
amounts remaining unspent. We are
also proposing at § 425.640(i) that ACOs
also be required to report this
information directly to CMS.
Under this proposal, if CMS
determined that an ACO used prepaid
shared savings for a prohibited use
under proposed § 425.640(e)(2),
allocated over 50 percent of their annual
maximum prepaid shared savings on
staffing and healthcare infrastructure as
proposed at § 425.640(e)(1)(i), or failed
to spend at least 50 percent of the
annual maximum prepaid shared
savings on direct beneficiary services,
CMS would require the ACO to
reallocate the funding in compliance
with § 425.640(e) and submit an
updated spend plan demonstrating the
reallocation by a deadline specified by
CMS and may withhold or terminate the
ACO’s receipt of prepaid shared savings
under proposed § 425.640(h)(1). CMS
could also take compliance action as
specified in §§ 425.216 and 425.218. If
an ACO fails to reallocate prepaid
shared savings it received by a deadline
specified by CMS, the ACO must repay
all prepaid shared savings it received
and may be subject to compliance action
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as specified in §§ 425.216 and 425.218.
CMS would 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.
Additionally, we note that under
existing § 425.314, ACOs would be
required to retain and provide CMS
with access to adequate books,
contracts, records, and other evidence to
ensure that CMS has the information
necessary to conduct appropriate
monitoring and oversight of ACOs’ use
of prepaid shared savings (for example,
invoices, receipts, and other supporting
documentation of prepaid shared
savings disbursements). To protect the
Shared Savings Program and the
Medicare Trust Funds, we would
reserve the right under §§ 425.314 and
425.316(a) to audit and monitor ACO
compliance with Shared Savings
Program requirements, including with
respect to prepaid shared savings. We
would conduct audits as necessary to
monitor and assess an ACO’s use of
prepaid shared savings and compliance
with program requirements related to
such payments. We seek comment on
these proposals.
h. Recoupment of Prepaid Shared
Savings
CMS anticipates that a vast majority
of ACOs receiving prepaid shared
savings would fully repay the amount
they receive prepaid shared savings
from their earned shared savings on an
annual basis. However, as prepaid
shared savings are an advance of the
shared savings payments an ACO is
expected to earn, we propose to recoup
prepaid shared savings from ACOs that
are unable to fully repay prepaid shared
savings through their earned shared
savings. This approach will also help
ensure that prepaid shared savings
would not result in additional
expenditures for the Shared Savings
Program, as required by section
1899(i)(3)(B) of the Act.
We are proposing to add a new
§ 425.640(g)(1) to recoup prepaid shared
savings from earned shared savings, as
defined in § 425.20, in each
performance year. If there are
insufficient shared savings to recoup the
prepaid shared savings made to an ACO
for a performance year, we would hold
paying future prepaid shared savings
payments and carry forward the
remaining balance owed to subsequent
performance year(s) in which the ACO
achieves shared savings.
Under new § 425.640(g)(2), we
propose that in circumstances where the
amount of shared savings earned by the
ACO is revised upward by CMS for any
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reason, we would reduce the
redetermined amount of shared savings
by the amount of prepaid shared savings
made to the ACO as of the date of the
redetermination. If the amount of shared
savings earned by the ACO is revised
downward by CMS for any reason, we
propose that the ACO would not receive
a refund of any portion of the prepaid
shared savings previously recouped or
otherwise repaid, and any prepaid
shared savings that are now outstanding
due to the revision in earned shared
savings must be repaid to CMS upon
request.
We propose under § 425.640(g)(3) that
if an ACO has an outstanding balance of
prepaid shared savings after the
calculation of shared savings or losses
for the final performance year of an
agreement period in which an ACO
receives prepaid shared savings, the
ACO must repay any outstanding
amount of prepaid shared savings it
received in full upon request from CMS.
CMS would 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
notification. If an ACO fails to repay any
outstanding amount of prepaid shared
savings within 90 days of the
notification, CMS would recoup that
amount from the ACO’s repayment
mechanism established under
§ 425.204(f).
For example, if an ACO received
$300,000 in prepaid shared savings
payments and earned shared savings of
$500,000 for the first performance year,
we would recoup $300,000 in prepaid
shared savings payments and make
$200,000 in reconciliation shared
savings payments to the ACO.
Alternatively, if an ACO received
$300,000 in prepaid shared savings and
earned shared savings of $200,000 for
the first performance year, we would
recoup only $200,000 in prepaid shared
savings payment and not make a
reconciliation shared savings payment
to the ACO. The ACO would have future
prepaid shared savings payments placed
on hold, and the outstanding balance of
$100,000 would be carried forward, to
be recouped in a future performance
year in which the ACO achieves shared
savings. Under a third scenario, if the
ACO does not earn sufficient shared
savings in all 5 performance years of its
agreement period, CMS would recoup
the outstanding balance directly from
the ACO under new § 425.640(g)(3). If
the ACO fails to repay the funding to
CMS, we would recoup the outstanding
balance from the ACO’s repayment
mechanism.
Under the new § 425.640(g)(4), we
propose that if an ACO or CMS
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61883
terminates its participation agreement
during the agreement period in which it
received prepaid shared savings, the
ACO must repay all outstanding prepaid
shared savings received in full. In such
a case, CMS would 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
notification. If an ACO fails to repay any
outstanding amount of prepaid shared
savings within 90 days of the
notification, CMS would recoup that
amount from the ACO’s repayment
mechanism established under
§ 425.204(f). We also propose edits to
§ 425.204(f) replacing the phrase
‘‘shared losses’’ with ‘‘shared losses and
any prepaid shared savings’’ in several
paragraphs to clarify that CMS would be
able to recoup outstanding prepaid
shared savings from an ACO’s
repayment mechanism. If the ACO
terminates its participation agreement
early in order to renew under a new
participation agreement, CMS may also
recover the amount owed by reducing
the amount of any future shared savings
the ACO may be eligible to receive.
In the event the ACO enters into
proceedings relating to bankruptcy,
whether voluntary or involuntary, we
are proposing under § 425.630(g)(5) that
the ACO must provide written notice of
the bankruptcy to CMS and to the U.S.
Attorney’s Office in the district where
the bankruptcy was filed, unless final
payment for the agreement period has
been made by either CMS or the
administrative or judicial review
proceedings relating to any payments
under the Shared Savings Program have
been fully and finally resolved. The
notice of bankruptcy must be sent by
certified mail no later than 5 days after
the petition has been filed and must
contain a copy of the filed bankruptcy
petition (including its docket number).
The notice to CMS must be addressed to
the CMS Office of Financial
Management at 7500 Security
Boulevard, Mailstop C3–01–24,
Baltimore, MD 21244, or such other
address as may be specified on the CMS
website for purposes of receiving such
notices.
i. OIG Safe Harbor Authority
CMS expects to make a determination,
if this rulemaking is finalized, that the
anti-kickback statute safe harbor for
CMS-sponsored model patient
incentives (§ 1001.952(ii)(2)) is available
to protect patient incentives that may be
permitted under the final rule, if issued.
Specifically, we expect to determine
that the CMS-sponsored models safe
harbor would be available to protect
direct beneficiary services provided to
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beneficiaries through the prepaid shared
savings payment option.
We propose to add a new paragraph
(d) to § 425.304 that notes that CMS has
determined that the Federal antikickback statute safe harbor for CMSsponsored model patient incentives (42
CFR 1001.952(ii)(2)) is available to
protect remuneration furnished in the
prepaid shared savings program option
of the Shared Savings Program in the
form of direct beneficiary services that
meets all safe harbor requirements set
forth in § 1001.952(ii)(2).
We are seeking comment on all
aspects of our proposals.
6. Advance Investment Payment
Policies
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a. Proposal To Allow ACOs Receiving
Advance Investment Payments to
Voluntarily Terminate Payments While
Continuing Participation in the Shared
Savings Program
Beginning January 1, 2024, CMS
implemented a new payment option in
the Shared Savings Program, advance
investment payments (AIP), and
codified AIP requirements at § 425.630.
In the CY 2023 PFS final rule (87 FR
69803 through FR 69805), we discussed
policies for termination of advance
investment payments from ACOs whose
participation agreements are terminated
for noncompliance with certain
requirements and finalized a
recoupment policy in which all advance
investment payments must be repaid to
CMS within 90 days from the date CMS
provided the ACO whose participation
agreement was terminated with written
notice of the amount due. These
regulations are codified at § 425.630(g)
and (h).
Currently, there are no regulations
that account for an ACO that seeks to
voluntarily terminate receipt of advance
investment payments from CMS, but
that wishes to remain in the Shared
Savings Program for the rest of their
agreement period. While we expect
advance investment payment
terminations to be an uncommon
occurrence, since advance investment
payments are a voluntary payment
option, ACOs should be able to decline
further participation. To accommodate
voluntary terminations of advance
investment payments for ACOs that
wish to continue participating in the
Shared Savings Program, CMS proposes
to modify program regulations at
§ 425.630(g) and (h). CMS proposes to
allow ACOs who wish to voluntarily
terminate receipt of advance investment
payments to do so and remain in the
Shared Savings Program. An ACO may
have justified business reasons for
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terminating receipt of advance
investment payments (such as an ACO’s
desire to enter a CMS Innovation Center
model whose eligibility criteria exclude
ACOs that receive AIP). CMS wishes to
amend its termination policies to
account for such a scenario. It is the best
interest of the Medicare Trust Funds
and the Shared Savings Program to
allow continued program participation
by ACOs that terminate receipt of
advance investment payments,
especially among ACOs and ACO
participants in, or that serve,
underserved communities. Therefore,
CMS proposes new regulations effective
January 1, 2025, to allow ACOs to
voluntarily terminate receipt of advance
investment payments while remaining
in the Shared Savings Program. Under
this proposal, CMS would develop an
advance investment payment voluntary
termination notification process to
allow ACOs to voluntarily terminate
receipt of these payments. If this
proposal is finalized, CMS would issue
guidance regarding this process to
participating Shared Savings Program
ACOs shortly after publication of the CY
2025 PFS final rule.
We propose to update § 425.630(g) to
state that if an ACO opts to voluntarily
terminate from the advance investment
payment option, they would be required
to return any outstanding advance
investment payments to CMS. Upon an
ACO notifying CMS that it wants to
terminate from the advance investment
payment option, CMS would then
provide a written notification to the
ACO of the total amount of recoupment
due. CMS would then require the ACO
to repay the amount due no later than
90 days after the receipt of such
notification. This aligns with how CMS
recoups advance investment payments
from ACOs whose advance investment
payments are involuntarily terminated
due to failure to comply with advance
investment payment eligibility
requirements under § 425.316(e)(3) and
with the repayment requirements under
§ 425.630(g)(4), if an ACO chooses to
terminate from the Shared Savings
Program.
ACOs that terminate from the advance
investment payment option would no
longer be monitored for their
appropriate use of advance investment
payments once the payments are repaid
to CMS. As such, ACOs that terminate
would no longer be subject to annual
reporting requirements for their spend
plans once the payments are repaid to
CMS. This proposal would allow an
ACO additional flexibility to determine
its best payment and participation
options, making it easier for an ACO
receiving advance investment payments
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to continue their participation in the
Shared Savings Program long-term. As
noted in the CY 2023 PFS final rule (87
FR 69784), advance investment
payments were designed to assist ACOs
that face difficulty funding the start-up
costs for forming ACOs, caring for
beneficiaries in underserved
communities, and achieving long term
success in the Shared Savings Program.
Allowing these ACOs more flexibility
would have the effect of supporting
continued Shared Savings Program
participation among these ACOs,
including those serving rural and
underserved populations.
CMS proposes to update
§ 425.630(g)(5) to state that if an ACO
notifies CMS that it no longer wants to
participate in the advance investment
payment option but does want to
continue its participation in the Shared
Savings Program, the ACO must repay
all outstanding advance investment
payments it received. CMS would
provide written notice 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.
Additionally, CMS proposes
conforming revisions to § 425.630(h) to
clarify that ACOs can voluntarily
terminate from the advance investment
payment option. Specifically, CMS
proposes to add a paragraph (h)(1)(iv) to
read ‘‘Voluntarily terminates payments
of advance investment payments but
continues its participation in the Shared
Savings Program.’’ CMS also proposed
conforming revisions to
§ 425.630(h)(1)(ii) and (iii). We seek
comment on these proposals. If
finalized, the proposed changes would
be effective beginning January 1, 2025.
b. Proposal To Recoup Advance
Investment Payments When CMS
Terminates the Participation Agreement
of an ACO
Under current advance investment
payment recoupment regulations, there
is no clear pathway for CMS to recoup
outstanding advance investment
payments if CMS terminates an ACO’s
participation agreement in accordance
with § 425.218(b). To address this and
reduce the risk to the Trust Fund, CMS
proposes to add new § 425.630(g)(6) to
require ACOs to repay any outstanding
advance investment payments in the
event that CMS terminates the ACO’s
Shared Savings Program participation
agreement.
Upon the termination of their Shared
Savings Program participation
agreement, the ACO’s advance
investment payments would cease
immediately under § 425.630(h)(1)(ii).
CMS would provide the ACO with
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written notification of the total amount
due for the full recoupment of advance
investment payments, and the ACO
must pay such amount within 90 days
after the receipt of such notification.
This approach aligns with how CMS
recoups advance investment payments
for ACOs under § 425.630(g)(4) if an
ACO receiving advance investment
payments chooses to voluntarily
terminate from the Shared Savings
Program. This proposal protects CMS
from not being able to recoup
outstanding advance investment
payments in the event CMS terminates
an ACO’s participation agreement in
accordance with § 425.218(b).
Specifically, CMS proposes to add
§ 425.630(g)(6) to state that if CMS
terminates the participation agreement
of an ACO that has an outstanding
balance of advance investment
payments owed to CMS, the ACO must
repay any outstanding advance
investment payments it received. CMS
would 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. If an ACO fails to fully
repay the advance investment payments
they received, CMS would carry forward
any remaining balance owed to
subsequent performance year(s) in
which the ACO achieves shared savings,
including in any performance year(s) in
a subsequent agreement period.
We also propose conforming edits to
§ 425.630(g)(3) to remove the phrase
‘‘paragraph (g)(4) of this section’’ and
adding in its place the phrase
‘‘paragraphs (g)(4) through (g)(6) of this
section.’’ This would allow CMS to
recoup more than the amount of shared
savings earned by an ACO in a
particular performance year in the event
that an ACO or CMS terminates an ACO
from the advance investment payment
option or the Shared Savings Program as
a whole. This proposal also would
require CMS to renumber regulations at
§ 425.630(g). Therefore, we propose a
conforming change to redesignate
§ 425.630(g)(5) as § 425.630(g)(7). We
seek comment on these proposals. If
finalized, these proposals would be
effective beginning January 1, 2025.
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7. Financial Methodology
a. Overview
In this section of this proposed rule,
we are proposing modifications to the
financial methodologies used under the
Shared Savings Program. The
modifications we propose would
encourage participation in the program
by removing barriers for ACOs serving
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underserved communities 499 as well as
provide greater specificity and clarity on
how CMS would perform certain
financial calculations in the Shared
Savings Program. Specifically, we are
proposing to create a health equity
benchmark adjustment, to potentially
provide an upward adjustment to an
ACO’s historical benchmark based on
the proportion of beneficiaries they
serve who are dually eligible or enrolled
in the Medicare Part D low-income
subsidy (LIS). We are also proposing to
establish a calculation methodology to
account for the impact of improper
payments in recalculating expenditures
and payment amounts used in Shared
Savings Program financial calculations,
upon reopening a payment
determination pursuant to § 425.315(a).
We are proposing to establish an
approach to identify significant,
anomalous, and highly suspect
(‘‘SAHS’’) billing activity in CY 2024 or
subsequent calendar years. We are
proposing to specify how we would
exclude payment amounts from
expenditure and revenue calculations
for the relevant calendar year for which
the SAHS billing activity is identified as
well as from historical benchmarks used
to reconcile the ACO for a performance
year corresponding to the calendar year
for which the SAHS billing activity was
identified to mitigate the impact of
SAHS billing activity. We seek comment
on a financial model that would allow
for higher risk and potential reward
than currently available under the
ENHANCED track while still meeting
the requirements for use of our authority
under section 1899(i)(3) of the Act,
among other considerations for the
financial model design. We are also
proposing certain modifications for
clarity and consistency in provisions of
the Shared Savings Program regulations
on calculation of the ACO risk score
growth cap in risk adjusting the
benchmark each performance year and
the regional risk score growth cap in
calculating the regional component of
the three-way blended benchmark
update factor.
499 As described in the CMS Framework for
Health Equity and consistent with Executive Order
13985 on Advancing Racial Equity and Support for
Underserved Communities Through the Federal
Government (86 FR 7009), the term ‘‘underserved
communities’’ refers to populations sharing a
particular characteristic, including geographic
communities that have been systematically denied
a full opportunity to participate in aspects of
economic, social, and civic life, as exemplified in
the definition of ‘‘equity.’’
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b. Health Equity Benchmark Adjustment
(1) Background
(a) Summary of Statutory and
Regulatory Background on Adjusting the
Historical Benchmark
Section 1899(d)(1)(B)(ii) of the Act
addresses how ACO benchmarks are to
be established, updated, and reset at the
start of each agreement period under the
Shared Savings Program. This provision
specifies that the Secretary shall
estimate a benchmark for each
agreement period for each ACO using
the most recent available 3 years of per
beneficiary expenditures for Parts A and
B services for Medicare FFS
beneficiaries assigned to the ACO. The
benchmark shall be reset at the start of
each agreement period. Section
1899(d)(1)(B)(ii) of the Act also provides
the Secretary with discretion to adjust
the historical benchmark by ‘‘such other
factors as the Secretary determines
appropriate.’’ Pursuant to this authority,
over time we have adopted a variety of
methods to adjust the historical
benchmark to meet certain policy goals.
Benchmarking policies applicable to
all ACOs in agreement periods
beginning on January 1, 2024, and in
subsequent years, are specified in
§ 425.652. We refer readers to
discussions of the benchmark
calculations in earlier rulemaking for
details on the development of the
current policies (see November 2011
final rule, 76 FR 67909 through 67927;
June 2015 final rule, 80 FR 32785
through 32796; June 2016 final rule, 81
FR 37953 through 37991; December
2018 final rule, 83 FR 68005 through
68030; CY 2023 PFS final rule, 87 FR
69875 through 69928; and CY 2024 PFS
final rule, 88 FR 79174 through 79208).
In the CY 2023 PFS final rule, we
adopted policies to modify the regional
adjustment under § 425.656 (refer to 87
FR 69915 through 69923) and to
reinstate a prior savings adjustment
under § 425.658 (refer to 87 FR 69898
through 69915). The modifications to
the regional adjustment are designed to
limit the impact of negative regional
adjustments on ACO historical
benchmarks and further incentivize
program participation among ACOs
serving high-cost beneficiaries. In the
CY 2024 PFS final rule (refer to 88 FR
79185 through 79196), we modified the
regional adjustment policy further 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. The prior savings
adjustment policy was developed such
that a renewing or re-entering ACO may
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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. In the CY 2024
PFS final rule (refer to 88 FR 79196
through 79200), we modified the prior
savings adjustment policy further 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
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.
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(b) Methodology for Determining the
Applicability of a Regional Adjustment
or Prior Savings Adjustment to the
ACO’s Historical Benchmark, for
Agreement Periods Beginning on or
After January 1, 2024
Under the benchmarking
methodology for agreement periods
beginning on January 1, 2024, and in
subsequent years, CMS calculates two
adjustments to the historical
benchmark, a regional adjustment (refer
to § 425.656) and a prior savings
adjustment (refer to § 425.658). We
determine which adjustment is applied
to the benchmark, either the regional
adjustment, prior savings adjustment, or
no adjustment (refer to § 425.652(a)(8)
and (c)).
Under the current methodology, the
adjustment that will apply in the
establishment of benchmarks for ACOs
entering an agreement period beginning
on January 1, 2024, and in subsequent
years, is calculated as follows:
• Step 1: Calculate capped regional
adjustment expressed as a single dollar
value as specified in § 425.656. CMS
calculates the regional adjustment to the
historical benchmark based on the
ACO’s regional service area
expenditures, making separate
calculations for the following
populations of beneficiaries: ESRD,
disabled, aged/dual eligible Medicare
and Medicaid beneficiaries, and aged/
non-dual eligible Medicare and
Medicaid beneficiaries.
++ Under § 425.656(c)(3), CMS caps
the per capita dollar amount for each
Medicare enrollment type at a dollar
amount equal to a percentage of national
per capita expenditures for Parts A and
B services under the original Medicare
fee-for-service (FFS) program in BY3 for
assignable beneficiaries in that
enrollment type identified for the 12month calendar year corresponding to
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BY3 using data from the CMS Office of
the Actuary.
-- Under § 425.656(c)(3)(i), for
positive adjustments, the per capita
dollar amount for a Medicare
enrollment type is capped at 5 percent
of the national per capita expenditure
amount for the enrollment type for BY3.
-- Under § 425.656(c)(3)(ii), for
negative adjustments, the per capita
dollar amount for a Medicare
enrollment type is capped at negative
1.5 percent of the national per capita
expenditure amount for the enrollment
type for BY3.
++ Under § 425.656(d)(1), CMS
expresses the regional adjustment as a
single value by taking a person year 500
weighted average of the Medicare
enrollment type-specific regional
adjustment values.
• Step 2: For eligible ACOs, calculate
the capped prior savings adjustment as
specified in § 425.658. Under
§ 425.658(c)(1), CMS calculates an
adjustment to the historical benchmark
to account for savings generated in the
3 years prior to the start of the ACO’s
current agreement period for renewing
or re-entering ACOs that were
reconciled for one or more performance
years in the Shared Savings Program
during this period.
• Step 3: Determine the final
adjustment to the benchmark, as
specified in § 425.652(a)(8). Compare
the regional adjustment in accordance
with § 425.656 and the prior savings
adjustment in accordance with
§ 425.658.
++ Under § 425.652(a)(8)(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 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/
500 To calculate person years: We sum the number
of Shared Savings Program-eligible months
(beneficiaries are only assigned a monthly
enrollment status for months in which they are
alive on 1st of the month, enrolled in both Parts A
and B, and not enrolled in a Medicare Group Health
Plan for the month) for each assigned beneficiary
for each Medicare enrollment type; we then divide
this number by 12 (the number of months in a
calendar year). Refer to the Medicare Shared
Savings Program, Shared Savings and Losses and
Assignment Methodology Specifications (version
#11, January 2023), available at https://
www.cms.gov/files/document/medicare-sharedsavings-program-shared-savings-and-losses-andassignment-methodology-specifications.pdf-2
(Section 3.1 Calculating ACO-Assigned Beneficiary
Expenditures).
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dual eligible Medicare and Medicaid
beneficiaries, and aged/non-dual
eligible Medicare and Medicaid
beneficiaries. Under § 425.652(a)(8)(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 value
as described in § 425.656(d), is negative
or zero, the ACO will not receive an
adjustment to its benchmark.
++ Under § 425.652(a)(8)(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:
-- Under § 425.652(a)(8)(iv)(A), 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.
-- Under § 425.652(a)(8)(iv)(B), 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.
++ Under § 425.652(a)(8)(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.
(c) Background on Incorporating Health
Equity Data Within the Shared Savings
Program
Development of a health equity
benchmark adjustment builds upon
Shared Savings Program policies
finalized in the CY 2023 and CY 2024
PFS final rules to advance health equity,
including the establishment of the
health equity adjustment to an ACO’s
MIPS quality performance category
score (applicable to all ACOs beginning
with performance year 2023) (87 FR
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69838 through 69857 and 88 FR 79114
through 79117); the availability of
advance investment payments to
eligible new, low revenue ACOs
entering a new agreement period
beginning on January 1, 2024, and in
subsequent years (87 FR 69782 through
69805 and 88 FR 79208 through 79216);
as well as changes to the benchmarking
methodology aimed to facilitate
participation by ACOs serving
medically complex or underserved
beneficiaries (87 FR 69915 through
69924 and 88 FR 79185 through 79195).
Further, in a Request for Information
in the CY 2023 PFS final rule (87 FR
69977 through 69979), we discussed
addressing health equity through
benchmarking and summarized related
comments. In the CY 2023 PFS final
rule (87 FR 69978), we explained our
interest in considering how direct
modification of benchmarks to account
for existing inequities in care can be
used to advance health equity. The vast
majority of commenters expressed
support for exploring methodologies to
address health equity via benchmarking
changes. Specifically, many of these
commenters noted that benchmark
adjustments could be an effective tool to
redirect resources to ACOs serving
underserved communities. Multiple
commenters commented specifically on
the health equity benchmark adjustment
approach utilized by the ACO Realizing
Equity, Access, and Community Health
(REACH) Model. Several of these
commenters expressed support for using
a similar methodology in implementing
a health equity benchmark adjustment
in the Shared Savings Program. In
response, we stated that we will
consider these comments in the
development of policies for future
rulemaking. Based on our experience
with adjustments under the current
benchmarking methodology, our
experience establishing policies to
advance health equity in the Shared
Savings Program, and the support
received for addressing health equity
through benchmarking in response to
the Request for Information, we have
determined that it would be timely to
implement a health equity benchmark
adjustment (HEBA) into the Shared
Savings Program’s benchmarking
methodology. Implementing a HEBA
would ensure benchmarks continue to
serve as a reasonable baseline when
ACOs serve high proportions of
beneficiaries who are members of
underserved communities and
incentivize ACOs to provide
coordinated care to beneficiaries who
are members of underserved
communities.
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A health equity benchmark
adjustment is likely to encourage more
participation in the Shared Savings
Program by ACOs that serve
beneficiaries who are members of rural
and underserved communities by
allowing them to participate with
potentially higher benchmarks. That, in
turn, would increase the likelihood that
they could earn shared savings and
increase the amount of those shared
savings payments and reduce the
financial barriers to forming ACOs that
providers who serve underserved
communities face. Benchmarks based on
historically observed spending could be
set too low if they are based on the
spending of a population of underserved
communities. An ACO serving such
communities could be harmed
financially if they are successful at
improving access to high-value care
during the performance period.
Additionally, the Congressional Budget
Office (CBO) recently reported high
start-up costs for providers in rural and
underserved communities as a barrier to
forming ACOs.501 These providers may
want to participate in ACOs but are
disincentivized due to steep start-up
costs.
A health equity benchmark
adjustment would also encourage
currently participating ACOs to attract
more beneficiaries who are members of
underserved communities and remain
in the Shared Savings Program. Direct
increases to benchmarks for ACOs
serving higher proportions of
beneficiaries who are members of
underserved communities would grant
additional financial resources to health
care providers accountable for the care
of these populations and may work to
offset historical patterns of
underspending that influence
benchmark calculations.
The ACO REACH Model incorporates
a HEBA to test a way to address
historical health inequities within CMS
ACO initiatives, with the intent of
incentivizing ACOs to seek out and form
relationships with beneficiaries who are
members of underserved communities.
The adjustment is intended to mitigate
the disincentive for ACOs to serve
underserved communities by
accounting for historically suppressed
spending levels for these populations. It
is a critical step towards enabling ACOs
to serve underserved communities in a
manner that reflects their health
501 Congressional Budget Office (CBO), ‘‘Medicare
Accountable Care Organizations: Past Performance
and Future Directions,’’ April 2024, available at
https://www.cbo.gov/system/files/2024-04/59879Medicare-ACOs.pdf.
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61887
needs.502 Likewise, the Shared Savings
Program aims to design a health equity
benchmark adjustment that achieves
those same goals while aligning the
program’s benchmarking policies and
health equity initiatives. The HEBA
proposal is informed by CMS’ initial
experience with the ACO REACH
Model, which includes a HEBA, that has
been associated with increased
participation in ACOs by safety net
providers.503 Increasing access to
providers participating in ACOs in rural
and other underserved areas remains a
priority for CMS to help address
inequities in ACO participation and
grow accountable care.
(2) Proposed Revisions
Relying on our authority under
section 1899(d)(1)(B)(ii) of the Act, we
are proposing a HEBA applicable to
ACOs in agreement periods beginning
on January 1, 2025, and in subsequent
years. The proposed HEBA would offer
a third method of upwardly adjusting an
ACO’s historical benchmark, in addition
to the existing regional adjustment and
prior savings adjustment. This upward
adjustment to the historical benchmark
is designed to benefit ACOs serving
larger proportions of beneficiaries from
underserved communities and receiving
lower regional adjustments (§ 425.656)
or lower prior savings adjustments
(§ 425.658) or receiving neither
adjustment. Under proposed
§ 425.652(a)(8)(ii), an ACO would
receive the highest of the positive
adjustments for which it is eligible,
either the regional adjustment, prior
savings adjustment, or health equity
benchmark adjustment. If an ACO is not
eligible to receive a prior savings
adjustment or a HEBA, and the regional
adjustment, expressed as a single value,
is negative or zero, then the ACO would
not receive an adjustment to its
benchmark.
By increasing the likelihood that an
ACO would earn shared savings and by
potentially increasing the amount of
shared savings earned, the HEBA is
meant to provide a greater financial
incentive for ACOs to serve more
beneficiaries from underserved
502 Centers for Medicare & Medicaid Services,
‘‘ACO Realizing Equity, Access, and Community
Health (REACH) Model Finance-Focused
Frequently Asked Questions’’ (Version 1, April
2022), available at https://www.cms.gov/priorities/
innovation/media/document/aco-reach-finfaqs.
503 See Rawal P, Seyoum S, Fowler E. ‘‘Advancing
Health Equity Through Value-Based Care: CMS
Innovation Center Update’’, Health Affairs
Forefront, June 4, 2024. DOI: 10.1377/
forefront.20240603.385559. Available at https://
www.healthaffairs.org/content/forefront/advancinghealth-equity-through-value-based-care-cmsinnovation-center-update.
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communities and to encourage ACOs
already serving higher proportions of
beneficiaries from underserved
communities to enter and remain in the
Shared Savings Program. Practices that
serve large proportions of beneficiaries
who are members of underserved
communities that may otherwise see
financial risk in joining the program
may be incentivized to form an ACO
and join the program with a health
equity benchmark adjustment policy in
place. In addition, currently
participating ACOs that may otherwise
see risk in attracting additional
beneficiaries from underserved
communities to their ACOs may be
incentivized to do so with a health
equity benchmark adjustment policy in
place. We note that, if finalized, the
proposed prepaid shared savings option
(see section III.G.5 of this proposed rule)
would operate synergistically with the
proposed HEBA, in that ACOs that have
been successful in earning shared
savings while serving larger proportions
of beneficiaries from underserved
communities would in subsequent years
have additional capabilities through
prepaid shared savings to address the
unmet health-related social needs of the
beneficiaries they serve and may have
higher benchmarks due to the HEBA.
We propose to calculate the HEBA as
the multiplicative product of the HEBA
scaler and the proportion of the ACO’s
assigned beneficiaries who are enrolled
in the Medicare Part D LIS or dually
eligible for Medicare and Medicaid. We
propose to calculate the HEBA scaler as
a measure of the difference between the
following two per-capita dollar values:
• 5 percent of national per capita
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
using data from the CMS Office of the
Actuary, expressed as a single value by
taking a person year weighted average of
the Medicare enrollment type-specific
values: ESRD, disabled, aged/dually
eligible for Medicare and Medicaid, and
aged/non-dually eligible for Medicare
and Medicaid, and
• the higher of the regional
adjustment expressed as a single value,
the prior savings adjustment, or no
adjustment, in the case where the
regional adjustment is negative and the
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ACO is not eligible for the prior savings
adjustment.
This approach would ensure that the
value of the HEBA itself cannot exceed
5 percent of national assignable per
capita expenditures expressed as a
single value using the ACO’s BY3
enrollment proportions, similar to the
cap applied to the regional adjustment
under § 425.656(c)(3) and the cap
applied to the prior savings adjustment
under § 425.658(c)(1)(ii).
For this proposed health equity
benchmark adjustment, we propose to
identify beneficiaries from underserved
communities as those who are enrolled
in the Medicare Part D LIS or dually
eligible for Medicare and Medicaid.
Furthermore, we propose to determine
the proportion of the ACO’s assigned
beneficiaries who are enrolled in the
Medicare Part D LIS or dually eligible
for Medicare and Medicaid using the
ACO’s performance year assigned
population. Because a higher proportion
of assigned beneficiaries who are
enrolled in Medicare Part D LIS or
dually eligible would result in a higher
HEBA, using the performance year
assigned population is expected to
incentivize ACOs to provide
coordinated care to beneficiaries who
are members of underserved
communities while accounting for
changes in the ACO’s population over
the agreement period.
We propose to provide ACOs with a
preliminary calculation of the HEBA
near the start of their agreement period
when final historical benchmarks are
determined, using the ACO’s BY3
assigned population in this preliminary
calculation of the proportion of the
ACO’s assigned beneficiaries who are
enrolled in the Medicare Part D LIS or
dually eligible for Medicare and
Medicaid. We would then update the
calculation when the ACO’s historical
benchmark is updated at the time of
financial reconciliation for the
performance year to reflect the ACO’s
performance year-assigned population
in the calculation of the proportion of
the ACO’s assigned beneficiaries who
are enrolled in the Medicare Part D LIS
or dually eligible for Medicare and
Medicaid.
We propose that ACOs with a
proportion of assigned beneficiaries
who are enrolled in the Medicare Part
D LIS or dually eligible for Medicare
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and Medicaid of less than 20 percent
would be ineligible for a HEBA.504 We
believe that imposing this threshold of
20 percent would reinforce that the
HEBA is intended for ACOs serving
higher proportions of beneficiaries who
are members of underserved
communities. Based on data from 2022,
the average proportion of ACO-assigned
beneficiaries enrolled in the Medicare
Part D LIS or dually eligible for
Medicare and Medicaid was roughly 15
percent. Thus, ACOs meeting the
threshold of 20 percent are serving a
larger-than-average proportion of
beneficiaries from underserved
communities. Absent such a threshold,
an ACO with a lower than average
regional adjustment or prior savings
adjustment (and therefore a larger HEBA
scaler) that is providing care for
relatively few beneficiaries from
underserved communities may receive a
sizable HEBA, which would reward the
ACO despite it not serving a significant
proportion of beneficiaries from
underserved communities. This would
not support the purpose of the HEBA,
which is to provide a greater financial
incentive for ACOs to serve more
beneficiaries from communities and
encourage practices already serving
higher proportions of beneficiaries from
underserved communities to enter and/
or remain in the Shared Savings
Program.
Under this proposed approach,
simulation analysis based on 456 ACOs
using historical benchmark data from
2023 indicates that 20 ACOs would
receive a HEBA greater than either the
prior savings adjustment or regional
adjustment. With the HEBA applied, the
average increase to historical
benchmarks among these 20 ACOs
would be $230 per capita, which
corresponds to an increase of 1.57
percent to their historical benchmarks
on average.
Tables 38 through 40 present
hypothetical examples to demonstrate
how the HEBA would work in practice.
BILLING CODE P
504 The health equity adjustment to an ACO’s
MIPS quality performance category score (87 FR
69838 through 69857 and 88 FR 79114 through
79117) has established a similar 20 percent
threshold. ACOs with an underserved multiplier of
less than 20 percent are not eligible to receive a
health equity adjustment (§ 425.512(b)).
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61889
TABLE 38: ACO with a HEBA Greater Than the Regional Adjustment and Prior Savings
Adjustment
Calculation Step
Step 1: Calculate Proportion
of Assigned Beneficiaries Who
Are Enrolled in Medicare Part
D LIS or Dually Eligible for
Medicare and Medicaid
Step 2: Calculate HEBA Scaler
Description of Calculation and Example
Proportion of PY-assigned beneficiaries enrolled in Medicare Part D LIS or
dually eligible for Medicare and Medicaid: 0.60
5 percent of the national per capita expenditures for assignable beneficiaries
in BY3 expressed as a single value: $600
Prior savings adjustment: $200
Regional adjustment expressed as single value: $100
Step 3: Calculate HEBA
Step 4: Determine Final
Adjustment to Benchmark
Difference between 5 percent of the national per capita expenditures for
assignable beneficiaries in BY3 expressed as a single value and the higher of
prior savings adjustment and regional adjustment expressed as a single value:
$600 - higher of $200 or $100 = $400
Product of the proportion of assigned beneficiaries who are enrolled in the
Medicare Part D LIS or dually eligible for Medicare and Medicaid and the
HEBA Scaler:
0.60 X $400 = $240
Highest of regional adjustment expressed as a single value, prior savings
adjustment, or HEBA:
Highest of $200, $100, or $240 = $240
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Per capita historical benchmark expenditures by enrollment type after
adjustment:
ESRD: $92,000 + $240 = $92,240
Disabled: $13,000 + $240 = $13,240
Aged/dual: $19,000 + $240 = $19,240
Aged/non-dual: $10,000 + $240 = $10,240
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TABLE 39: ACO with a HEBA Less Than the Regional Adjustment and Prior Savings
Adjustment
Calculation Step
Step 1: Calculate
Proportion of
Assigned Beneficiaries
Who Are Enrolled in
Medicare Part D LIS
or Dually Eligible for
Medicare and
Medicaid
Step 2: Calculate
HEBA Scaler
Description of Calculation and Example
Proportion of PY-assigned beneficiaries enrolled in Medicare Part D LIS or dually
eligible for Medicare and Medicaid: 0.25
5 percent of the national per capita expenditures for assignable beneficiaries in BY3
expressed as a single value: $600
Prior savings adjustment: $200
Regional adjustment expressed as single value: $300
Step 3: Calculate
HEBA
Step 4: Determine
Final Adjustment to
Benchmark
Difference between 5 percent of the national per capita expenditures for assignable
beneficiaries in BY3 expressed as a single value and the higher of prior savings
adjustment and regional adjustment expressed as a single value:
$600 - higher of $200 or $300 = $300
Product of the proportion of assigned beneficiaries who are enrolled in the Medicare
Part D LIS or dually eligible for Medicare and Medicaid and the HEBA Scaler:
0.25 X $300 = $75
Highest of regional adjustment expressed as a single value, prior savings adjustment,
orHEBA:
Highest of$200, $300, or $75 = $300
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Per capita historical benchmark expenditures by enrollment type after adjustment:
ESRD: $92,000 + $300 = $92,300
Disabled: $13,000 + $300 = $13,300
Aged/dual: $19,000 + $300 = $19,300
Aged/non-dual: $10,000 + $300 = $10,300
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
61891
TABLE 40: ACO Ineligible for the HEBA
Calculation Step
Step 1: Calculate Proportion
of Assigned Beneficiaries
Who Are Enrolled in the
Medicare Part D LIS or
Dually Eligible for Medicare
and Medicaid
Step 2: Calculate HEBA
Scaler
Description of Calculation and Example
Proportion of PY-assigned beneficiaries enrolled in Medicare Part D LIS or
dually eligible for Medicare and Medicaid: 0.10
5 percent of the national per capita expenditures for assignable beneficiaries in
BY3 expressed as a single value: $600
Prior savings adjustment: $200
Regional adjustment expressed as single value: $300
Difference between 5 percent of the national per capita expenditures for
assignable beneficiaries in BY3 expressed as a single value and the higher of
prior savings adjustment and regional adjustment expressed as a single value:
$600 higher of $200 or $300 = $300
Step not applicable as ACO has a proportion of assigned beneficiaries who are
enrolled in the Medicare Part D LIS or dually eligible for Medicare and
Medicaid less than 0.20 and is ineligible for a HEBA as a result.
Higher of regional adjustment expressed as a single value or prior savings
adjustment:
Higher of $200 or $300 = $300
Step 3: Calculate HEBA
Step 4: Determine Final
Adjustment to Benchmark
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BILLING CODE C
We propose to implement the changes
described in this section through
revisions to § 425.652 and the addition
of § 425.662. Specifically, within
§ 425.652, which 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 § 25.652(a)(8). As
proposed, this revised provision would
describe how we would determine and
apply the adjustment to an ACO’s
benchmark, if any, based on a
comparison of the ACO’s regional
adjustment expressed as a single value,
prior savings adjustment, and the
proposed health equity benchmark
adjustment. Furthermore, we propose to
amend § 425.652 by redesignating
paragraphs (a)(9)(v) and (vi) as
paragraphs (a)(9)(vi) and (vii),
respectively, and to specify in a new
paragraph (a)(9)(v) the adjustments
made to the health equity benchmark
adjustment for the first performance
year during the term of the agreement
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period and in the second and each
subsequent performance year during the
term of the ACO’s agreement period, if
applicable. We also propose conforming
changes in newly redesignated
§ 425.652(a)(9)(vi), specifying that CMS
redetermines the adjustment to
benchmark in accordance with
§ 425.652(a)(8), to list the HEBA along
with the regional adjustment and prior
savings adjustment. In the proposed
new section of the regulation at
§ 425.662 we describe the calculation of
the HEBA. We also propose to make
conforming changes to § 425.658(d),
which describes the applicability of the
prior savings adjustment, to include
consideration of the HEBA in addition
to the regional adjustment, in
determining the adjustment (if any) that
would be applied to the ACO’s
benchmark. We seek comment on these
proposals.
In combination with the proportion of
ACO-assigned beneficiaries who are
enrolled in the Medicare Part D LIS or
are dually eligible for Medicare and
Medicaid, we are seeking comment on
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the use of the Area Deprivation Index
(ADI) to identify beneficiaries from
underserved communities for purposes
of determining eligibility for and the
amount of any health equity benchmark
adjustment. For example, similar to how
the ADI is used in the underserved
multiplier as part of the calculation of
the health equity adjustment to an
ACO’s MIPS Quality performance
category score (87 FR 69838 through
69857 and 88 FR 79114 through 79117),
we are considering taking the higher of
either the proportion of the ACO’s
assigned beneficiaries residing in a
census block group with an ADI
national percentile rank of at least 85 or
the proportion of the ACO’s assigned
beneficiaries who are enrolled in the
Medicare Part D LIS or dually eligible
for Medicare and Medicaid to determine
eligibility for and the amount of any
health equity benchmark adjustment.
CMS will explore how best to
incorporate geographic parameters into
Shared Savings Program benchmark
adjustments, informed by the current
use of the ADI in other health equity
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EP31JY24.069
Per capita historical benchmark expenditures by enrollment type after
adjustment:
ESRD: $92,000 + $300 = $92,300
Disabled: $13,000 + $300 = $13,300
Aged/dual: $19,000 + $300 = $19,300
Aged/non-dual: $ I 0,000 + $300 = $10,300
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provisions of the Shared Savings
Program. CMS will also consider
learnings from the Innovation Center’s
ACO REACH Model, which is testing
the use of the ADI as a component of the
model’s HEBA. By considering the ADI
in addition to the proportion of ACOassigned beneficiaries who are enrolled
in the Medicare Part D LIS or are dually
eligible for Medicare and Medicaid, the
HEBA would more closely align with
existing Shared Savings Program
policies to advance health equity, such
as the health equity adjustment to an
ACO’s MIPS Quality performance
category score (87 FR 69838 through
69857 and 88 FR 79114 through 79117)
and the calculation of the amount of
quarterly advance investment payments
made available to eligible new, low
revenue ACOs (87 FR 69782 through
69805 and 88 FR 79208 through 79216).
Additionally, recent analyses have
found that the ADI weights 2 variables
(median home value and median
income) higher relative to the weights
associated with the other 15 variables in
the index, which may have limited
contributions in determining the ADI. In
many indexes, variables are
standardized to the same range for ease
of comparison, prior to incorporation
into the index. The ADI does not
standardize its variables; median home
value and median income are measured
on their local area dollar-value scales,
which are larger than the scales on
which the other variables are measured.
Some researchers have reported that,
without standardization, the ADI
overemphasizes the 2 variables (median
home value and median income), a
finding that may underscore the
importance of using standardized
values.505 506 507 We seek comment on
considering the ADI for purposes of
determining eligibility for and the
amount of any health equity benchmark
adjustment, and related factors
including the calculation of the ADI.
505 See Hannan, EL, et al. The Neighborhood
Atlas Area Deprivation Index For Measuring
Socioeconomic Status: An Overemphasis On Home
Value. Health Affairs, vol. 42, no. 5 (May 2023):
702–709. Available at https://
www.healthaffairs.org/doi/full/10.1377/
hlthaff.2022.01406.
506 See Rehkopf, DH, and Phillips, RL, Jr. The
Neighborhood Atlas Area Deprivation Index And
Recommendations For Area-Based Deprivation
Measures. Health Affairs, vol. 42, no. 5 (May 2023):
710–711. Available at https://
www.healthaffairs.org/doi/full/10.1377/
hlthaff.2023.00282.
507 See Petterson, S. Deciphering the
Neighborhood Atlas Area Deprivation Index: the
consequences of not standardizing. Health Affairs
Scholar, volume 1, issue no. 5 (November 2023),
qxad063; Available at https://academic.oup.com/
healthaffairsscholar/article/1/5/qxad063/7342005.
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c. Reopening ACO Payment
Determinations
(1) Background
(a) Statutory Background on Shared
Savings Program Financial Calculations
Section 1899(d)(1)(B)(ii) of the Act
provides for the calculation and update
of ACO benchmarks under the Shared
Savings Program. This provision
specifies that the Secretary shall
estimate a benchmark for each
agreement period for each ACO using
the most recent available 3 years of per
beneficiary expenditures for Parts A and
B services for Medicare FFS
beneficiaries assigned to the ACO. Such
benchmark shall be adjusted for
beneficiary characteristics and such
other factors as the Secretary determines
appropriate and updated by the
projected absolute amount of growth in
national per capita expenditures for
Parts A and B services under the
original Medicare FFS program, as
estimated by the Secretary. Further, an
ACO’s benchmark must be reset at the
start of each agreement period. Section
1899(d)(1)(B)(i) of the Act specifies that,
in each year of the agreement period, an
ACO is eligible to receive payment for
shared savings only if the estimated
average per capita Medicare
expenditures under the ACO for
Medicare FFS beneficiaries for Parts A
and B services, adjusted for beneficiary
characteristics, is at least the percent
specified by the Secretary below the
applicable benchmark under section
1899(d)(1)(B)(ii) of the Act.
Section 1899(i)(3) of the Act
authorizes the Secretary to use other
payment models, if the Secretary
determines it is appropriate, and if the
Secretary determines that doing so
would improve the quality and
efficiency of items and services
furnished under Title XVIII and the
alternative methodology would result in
program expenditures equal to or lower
than those that would result under the
statutory payment model. As discussed
in earlier rulemaking, we have used the
authority under section 1899(i)(3) of the
Act to adopt alternative policies to the
provisions of section 1899(d)(1)(B) of
the Act for updating the historical
benchmark 508 and calculating
508 Such as using only assignable beneficiaries
instead of all Medicare FFS beneficiaries in
calculating the benchmark update based on national
FFS expenditures (81 FR 37985 through 37989),
calculating the benchmark update using factors
based on regional FFS expenditures (81 FR 37977
through 37981), calculating the benchmark update
using a blend of national and regional expenditure
growth rates (83 FR 68027 through 68030),
removing payment amounts for episodes of care for
treatment of COVID–19 from expenditures used to
calculate the benchmark update (85 FR 27577
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performance year expenditures,509
among other factors.510 We have also
used our authority under section
1899(i)(3) of the Act to establish the
Shared Savings Program’s two-sided
payment models,511 and to mitigate
shared losses owed by ACOs affected by
extreme and uncontrollable
circumstances during PY 2017 and
subsequent performance years.512
(b) Background on Shared Savings
Program Reopening Policy and
Financial Calculation Methodology
Under § 425.315(a)(1), if CMS
determines that the amount of shared
savings due to the ACO or the amount
of shared losses owed by the ACO has
been calculated in error CMS may
reopen the initial determination or a
final agency determination under
subpart I and issue a revised initial
determination: (i) at any time in the case
of fraud or similar fault as defined in
§ 405.902; 513 or (ii) not later than 4
years after the date of the notification to
through 27582), and calculating the benchmark
update using an Accountable Care Prospective
Trend/national-regional three-way blended update
factor (87 FR 69881 through 69898).
509 Such as excluding indirect medical education
and disproportionate share hospital payments from
ACO performance year expenditures (76 FR 67920
through 67922), determining shared savings and
shared losses for the 6-month performance years (or
performance period) in 2019 using expenditures for
the entire CY 2019 and then pro-rating these
amounts to reflect the shorter performance year or
performance period (83 FR 59949 through 59951, 83
FR 67950 through 67956), removing payment
amounts for episodes of care for treatment of
COVID–19 from performance year expenditures (85
FR 27577 through 27582), and the exclusion of the
supplemental payment for IHS/Tribal hospitals and
Puerto Rico hospitals from performance year
expenditures (87 FR 69954 through 69956).
510 Such as allowing for advance investment
payments (87 FR 69782 through 69805), and
expansion of the criteria for certain low revenue
ACOs participating in the BASIC track to qualify for
shared savings in the event the ACO does not meet
the MSR as required under section 1899(d)(1)(B)(i)
of the Act (87 FR 69946 through 69952).
511 See earlier rulemaking establishing two-sided
models: Track 2 (76 FR 67904 through 67909),
Track 3 (subsequently renamed the ENHANCED
track) (80 FR 32771 and 32772), and the BASIC
track (83 FR 67834 through 67841). We also used
our authority under section 1899(i)(3) of the Act to
remove payment amounts for episodes of care for
treatment of COVID–19 from ACO participants’
Medicare FFS revenue used to determine the loss
sharing limit in the two-sided models of the BASIC
track (85 FR 27577 through 27582).
512 See earlier rulemaking establishing policies for
mitigating shared losses owed by ACOs affected by
extreme and uncontrollable circumstances (82 FR
60916 and 60917, 83 FR 59974 through 59977).
513 As defined in § 405.902, ‘‘similar fault’’ means
to obtain, retain, convert, seek, or receive Medicare
funds to which a person knows or should
reasonably be expected to know that he or she or
another for whose benefit Medicare funds are
obtained, retained, converted, sought, or received is
not legally entitled. This includes, but is not limited
to, a failure to demonstrate that he or she filed a
proper claim as defined in 42 CFR part 411.
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the ACO of the initial determination of
savings or losses for the relevant
performance year, for good cause.
In accordance with § 425.315(a)(2),
good cause may be established when (i)
there is new and material evidence that
was not available or known at the time
of the payment determination and may
result in a different conclusion, or (ii)
the evidence that was considered in
making the payment determination
clearly shows on its face that an obvious
error was made at the time of the
payment determination. Section
425.315(a)(3) specifies that a change of
legal interpretation or policy by CMS in
a regulation, CMS ruling or CMS general
instruction, whether made in response
to judicial precedent or otherwise, is not
a basis for reopening a payment
determination under the Shared Savings
Program regulations. CMS has sole
discretion to determine whether good
cause exists for reopening a payment
determination (§ 425.315(a)(4)).
We first adopted a reopening policy in
the November 2011 final rule, where we
finalized at § 425.314(a)(4) a provision
reserving the right for CMS to reopen
the initial determination and issue a
revised initial determination, if as a
result of any inspection, evaluation, or
audit, it is determined that the amount
of shared savings due to the ACO or
amount of shared losses owed by the
ACO has been calculated in error (see 76
FR 67957 through 67958, and 67982). In
the June 2016 final rule, we revised the
Shared Savings Program regulations,
including to remove the provision in
§ 425.314(a)(4), and further specify the
reopening policy in a new section of the
regulation at § 425.315 (81 FR 37997
through 38002, and 38013 through
38014). We subsequently revised
§ 425.315 to apply the policies on
reopening determinations to payment
determinations for a 6-month
performance year or 6-month
performance period during CY 2019
(refer to the November 2018 final rule,
83 FR 59958 and 60092, and the
December 2018 final rule, 83 FR 67955
through 67967), and to ACOs
participating in the BASIC track (refer to
the December 2018 final rule, 83 FR
67842 and 68068). In the CY 2023 PFS
final rule, we clarified the
circumstances in which CMS would
exercise discretion to reopen the initial
determination of an ACO’s financial
performance for good cause to correct
errors in the determination of MIPS
Quality performance category scores
that affect the determination of whether
an ACO is eligible for shared savings,
the amount of shared savings due to the
ACO, or the amount of shared losses
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owed by the ACO (see 87 FR 69868
through 69869).
Most recently, in the CY 2024 PFS
final rule, we finalized an approach to
recalculating 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 (88 FR 79195 through
79200). In the CY 2024 PFS final rule,
we also discussed a proposed timing
cutoff such that changes to savings or
losses for a benchmark year that were
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 any
subsequent performance year during the
relevant agreement period but would
not be retroactively applied to
completed performance years in the
agreement period (88 FR 79198 through
79200). We stated that we believed 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. However, we also noted
that we would continue 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
(88 FR 79199). We refer readers to these
discussions in past rulemaking for
additional details.
In our earlier rulemaking, we did not
discuss the specific methodology that
would be employed for recalculating an
ACO’s shared savings or shared losses
in the event of a reopening in order to
issue a revised initial determination. As
additional background, in the following
discussion, we summarize the general
approach to identification and use of
payment amounts from Medicare FFS
Parts A and B FFS claims and certain
other payment amounts in Shared
Savings Program calculations.
Under the Shared Savings Program,
providers and suppliers continue to bill
for services furnished to Medicare
beneficiaries and receive FFS payments
under traditional Medicare. CMS uses
payment amounts for Parts A and B FFS
claims for calculating benchmark and
performance year expenditures and
determining benchmark update factors
as specified in the Shared Savings
Program regulations in subpart G. These
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61893
operations typically require the
determination of expenditures for Parts
A and B services under the original
Medicare FFS program for a specified
population of Medicare FFS
beneficiaries or the Medicare Parts A
and B FFS revenue of ACO participants.
The Medicare FFS beneficiary
population for which expenditures are
determined may differ depending on the
specific program operation being
performed and may reflect expenditures
for the ACO’s assigned beneficiaries,
assignable beneficiaries, or all Medicare
FFS beneficiaries. The applicable
Medicare FFS beneficiary population is
specified in the regulations governing
each program operation.
In calculating expenditures for
Medicare FFS beneficiaries used in
Shared Savings Program calculations,
CMS uses payment amounts included
on Parts A and B FFS claims with dates
of service in the relevant benchmark or
performance year, allowing for a 3month claims run out, as follows: claim
payment amounts identified for
inpatient, Skilled Nursing Facility
(SNF), outpatient, Home Health Agency
(HHA), and hospice claims at any
provider; and line item payment
amounts identified for carrier (including
physician/supplier Part B) and Durable
Medical Equipment, Prosthetics,
Orthotics & Supplies (DMEPOS) claims.
For both Parts A and B claims, CMS
excludes payments on denied claims or
line items from the calculation, for
claims or line items with dates of
service within the relevant benchmark
year or performance year, processed
before the end of the 3-month claims
run out period. In calculating
expenditure amounts for Medicare FFS
beneficiaries under the Shared Savings
Program, CMS makes certain
adjustments,514 which if applicable,
exclude indirect medical education
(IME) and disproportionate share
hospital (DSH) payments, and the
supplemental payment for IHS/Tribal
hospitals and Puerto Rico hospitals, and
take into consideration individually
beneficiary identifiable final payments
made under a demonstration, pilot or
time limited program. We also account
for certain population-based payments
or other similarly structured payments
made under other Medicare shared
savings initiatives, specifically the
Pioneer ACO Model, Next Generation
ACO Model, Vermont All-Payer ACO
Model, and ACO REACH Model (as
514 The Shared Savings Program’s financial
models and benchmarking policies, among other
program policies, have changed over time as
described in earlier rulemaking (refer to section
III.G.1.b. of this proposed rule), and as outlined in
the provisions of subpart G.
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applicable). Population-based payments
are a per-beneficiary per month
payment amount intended to replace
some or all of the FFS payments with
prospective monthly payment.515
The Shared Savings Program’s
existing financial methodology does not
fully account for actions taken to protect
the integrity of the Medicare program, or
address the impact of improper
payments, including improper
payments resulting from fraud or similar
fault on program calculations. For
instance, demanded overpayment
determinations resulting in adjusted
claim or line item payment amounts
after the 3-month claims run out period,
or aggregate amounts that are not linked
to specific claims or line items, are not
accounted for in Shared Savings
Program expenditure calculations.
Additionally, under the existing
financial methodology for the Shared
Savings Program, we lack a means to
account for improper payment amounts
identified in a settlement agreement
between a provider or supplier and the
Government or a court’s judgment,
including pursuant to conduct by
individuals or entities performing
functions or services related to an
ACO’s activities. Under the proposed
approach described in section
III.G.7.c.(2).(c) of this proposed rule, the
term ‘‘improper payment’’ for purposes
of the Shared Savings Program would
include an amount associated with a
demanded overpayment determination
and certain amounts identified in a
settlement agreement or judgment that
have the potential to impact program
financial calculations. Since January
2023, we have evaluated several cases
where such improper payments may
have impacted one or more reconciled
performance years for an ACO under the
Shared Savings Program, including
cases where ACOs reported concerns
about alleged fraud or similar fault to
CMS. It is thus timely and appropriate
to undertake notice and comment
rulemaking to establish a calculation
methodology to account for the impact
of improper payments in recalculating
expenditures and payment amounts
used in Shared Savings Program
financial calculations, upon reopening a
payment determination pursuant to
§ 425.315(a); to describe factors that we
may consider in exercising our
515 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
(refer to Section 3.1 Calculating ACO-Assigned
Beneficiary Expenditures).
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discretion to reopen an ACO’s payment
determination under which we apply
the proposed methodology to
recalculate the ACO’s financial
performance; and to propose to establish
a process by which an ACO could
request a reopening of an initial
determination of shared savings or
shared losses. Our experience reviewing
several cases supported the
development of our proposed revisions
to Shared Savings Program policies.
(2) Proposed Revisions
This section of this proposed rule
includes a proposed change to the
provision specifying CMS’ discretion to
reopen payment determinations under
§ 425.315(a)(4) (as described in section
III.G.7.c.(2).(a) of this proposed rule).
We discuss and seek comment on the
circumstances in which we would
exercise our discretion to reopen a
payment determination and issue a
revised initial determination to account
for the impact of identified improper
payments on Shared Savings Program
calculations (as described in section
III.G.7.c.(2).(b) of this proposed rule).
We propose modifications to the Shared
Savings Program regulations to specify a
calculation methodology to account for
the impact of identified improper
payments in recalculating expenditures
and payment amounts used in Shared
Savings Program financial calculations,
upon reopening a payment
determination pursuant to § 425.315(a)
(as described in section III.G.7.c.(2).(c)
of this proposed rule). We also propose
certain adjustments to Shared Savings
Program benchmark calculations to
account for the impact of identified
improper payments, in the event a
performance year for which we issue a
revised initial determination becomes a
benchmark year of an ACO’s current
agreement period, and when CMS has
not yet issued an initial determination
for a performance year of the ACO’s
current agreement period (as described
in section III.G.7.c.(2).(d) of this
proposed rule). Lastly, we propose a
process for ACOs to request that CMS
reopen a payment determination (as
described in section III.G.7.c.(2).(e) of
this proposed rule), and briefly discuss
the role of ACOs in preventing and
reporting Medicare fraud (as described
in section III.G.7.c.(2).(f) of this
proposed rule). Our specific proposals
are discussed in detail in the following
sections.
We propose that the policy changes
discussed in this section of this
proposed rule would be effective
January 1, 2025, unless specified
otherwise. Should the proposed policies
be finalized, the policies would apply to
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Sfmt 4702
reopening requests made on or after
January 1, 2025. As described in section
III.G.7.c.(2).(e) of this proposed rule, we
propose to establish a process by which
an ACO may request a reopening
review. If finalized, we anticipate
continuing to evaluate previously
received reopening requests for
performance years for which initial
determinations were issued prior to
January 1, 2025, consistent with the
timeframes specified under
§ 425.315(a)(1). We anticipate
consistently applying the recalculation
methodology to account for the impact
of improper payments, described in
section III.G.7.c.(2).(c) of this proposed
rule, if finalized, in recalculating
expenditures and payment amounts
used in Shared Savings Program
financial calculations, upon reopening a
payment determination pursuant to
§ 425.315(a).
(a) Proposed Change to Provision
Specifying CMS’ Discretion To Reopen
Payment Determinations
In earlier rulemaking we explained
that CMS would have discretion to
reopen a payment determination for
fraud or similar fault, or good cause, as
reflected in the provisions in
§ 425.315(a)(1) and (4). The latter
provision expressly provides that CMS
has sole discretion to determine
whether good cause exists for reopening
a payment determination. In the June
2016 final rule, in restating the
discussion of the proposal from the
February 2016 proposed rule, we
explained that CMS would have
discretion to reopen a payment
determination at any time in the case of
fraud or ‘‘similar fault,’’ as defined in
§ 405.902 (81 FR 37998).
We continue to believe that it is
important to maintain CMS’ sole
discretion in determining whether to
reopen a payment determination. We
also believe it is important to preserve
CMS’ flexibility in determining whether
reopening is warranted to address the
impact of fraud or similar fault on
Shared Savings Program calculations, in
particular given the potential for various
actions to be taken by CMS, law
enforcement agencies and courts in
response to fraud or similar fault. Thus,
we are proposing revisions to
§ 425.315(a)(4) to make clear CMS’
discretion to determine whether to
reopen a payment determination applies
in the case of fraud or similar fault, as
well as to determining whether good
cause exists to reopen a payment
determination.
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(b) Considerations for Reopening a
Payment Determination To Account for
Improper Payments
In the discussion that follows we
describe factors CMS may consider to
inform our decision of whether to
reopen an initial determination of an
ACO’s financial performance pursuant
to § 425.315(a)(1)(i) or (ii) to account for
the impact of improper payments that
affect the determination of whether an
ACO is eligible for shared savings or
liable for shared losses, and the amount
of shared savings due to the ACO or the
amount of shared losses owed by the
ACO. We welcome comments on these
considerations. We also anticipate
revisiting these considerations as we
gain experience with processing ACO
reopening requests as described in
section III.G.7.c.(2).(e) of this proposed
rule, reopening payment determinations
and applying the calculation
methodology described in section
III.G.7.c.(2).(c) of this proposed rule and
applying the benchmark adjustment
described in section III.G.7.c.(2).(d) of
this proposed rule. If appropriate, we
may revisit these considerations for
exercising our discretion to reopen
payment determinations in future notice
and comment rulemaking.
As an initial matter, the Shared
Savings Program would need to identify
improper payments that have the
potential to impact program financial
calculations. The Shared Savings
Program depends on input from the
CMS Center for Program Integrity (CPI)
and law enforcement agencies
(including the Department of Justice) to
identify and quantify improper
payments potentially impacting
expenditures used in program
calculations that are not otherwise
accounted for in Shared Savings
Program expenditure calculations as
described in this section of this
proposed rule. This could include: (1)
certain demanded overpayment
determinations, such as demanded
overpayment amounts that result in
adjusted claim or line item payment
amounts associated with dates of service
during a performance year or
benchmark year, where the adjustment
occurs after the 3-month claims run out
period, and demanded extrapolated
overpayment amounts which are
aggregate amounts that are not linked to
specific claims or line items and are not
currently accounted for in Shared
Savings Program expenditures; 516 and
516 For additional information on overpayment
procedures and overpayment estimation, see, for
example, Medicare Program Integrity Manual,
Chapter 8—Administrative Actions and Sanctions
and Statistical Sampling for Overpayment
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(2) improper payments resulting from
conduct by individuals or entities
performing functions or services related
to an ACO’s activities as identified in
certain settlement agreements or
judgments. Refer to section
III.G.7.c.(2).(c) of this proposed rule for
discussion of considerations for
identifying these amounts. Further, as
discussed in greater detail in section
III.G.7.c.(2).(e) of this proposed rule,
ACOs can play an important role in
identifying for CMS improper payments
that may impact Shared Savings
Program calculations. ACO reopening
requests submitted to CMS may be
another means by which the Shared
Savings Program becomes aware of
improper payments impacting ACO
financial calculations; however, CMS
would retain discretion over whether to
reopen payment determinations after
reviewing information provided in such
requests.
Second, we anticipate needing to
perform an initial analysis of whether
the improper payments would warrant
reopening the ACO’s payment
determination. This analysis may
include a number of factors, such as
whether the improper payments meet
the requirements for reopening for fraud
or similar fault in accordance with
§ 425.315(a)(1)(i), or for good cause in
accordance with § 425.315(a)(1)(ii) and
(a)(2). A variety of circumstances could
lead CMS, law enforcement agencies or
courts to determine whether good cause
exists or whether fraud or similar fault
has occurred. The timelines associated
with the related investigations, and the
potential for various actions to be taken
in response, can make it challenging to
identify a one-size-fits-all approach to
addressing the impact of improper
payments on Shared Savings Program
calculations. We note that once we are
notified of potential improper payments
impacting Shared Savings Program
calculations, it may take months or
years to determine the actual amount of
any improper payments impacting an
ACO’s payment determination,
particularly if we are awaiting the
conclusion of program integrity and law
enforcement investigations, among other
possible determinations about the
related conduct of providers or
suppliers. Additionally, administrative
action and judicial action leading to the
identification of improper payments
may be subject to appeal, and ultimately
the amount of the improper payments
may be redetermined or otherwise
Estimation, available at https://www.cms.gov/
regulations-and-guidance/guidance/manuals/
downloads/pim83c08.pdf.
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amended.517 It would further protract
the timeline for considering use of
improper payments in recalculating
ACO financial performance results to
await the outcome of any appeal of an
improper payment.
Since there could be a variety of
reasons for which CMS seeks to recoup
an overpayment amount from a provider
or supplier, there are many possible
circumstances that could warrant
reopening under § 425.315. As an
example, we may consider a
combination of factors in evaluating
whether demanded overpayment
determinations would be the basis for
reopening for fraud or similar fault
under § 425.315(a)(1)(i).518 For instance,
we may consider whether there is
‘‘reliable evidence’’ (as defined
according to § 405.902, which means
evidence that is relevant, credible, and
material) of similar fault to warrant
reopening a Shared Savings Program
payment determination.519 For purposes
of the Shared Savings Program’s
reopening policy, we may find there is
reliable evidence of similar fault when
a demanded overpayment determination
was issued to a provider or supplier for
which CMS has revoked or deactivated
their Medicare billing privileges, or for
which there is a closed law enforcement
investigation, among other possible
factors. Although demanded
overpayment determinations are subject
to appeal, we believe use of these
amounts in reopening and recalculating
an ACO’s financial performance under
517 For instance, a provider receiving an initial
demand letter for an overpayment may appeal the
overpayment by requesting a redetermination,
among other actions. See for example, CMS, MLN
Fact Sheet, ‘‘Medicare Overpayments’’ (MLN006379
October 2023), available at https://www.cms.gov/
outreach-and-education/medicare-learningnetwork-mln/mlnproducts/downloads/
overpaymentbrochure508-09.pdf. The Medicare
Parts A and B appeals process includes multiple
levels of appeal. See for example, CMS, MLN
Booklet, ‘‘Medicare Parts A & B Appeals Process’’
(MLN006562 November 2023), available at https://
www.cms.gov/files/document/mln006562-medicareparts-b-appeals-process.pdf.
518 While this example presumes reopening for
fraud or similar fault, there may be additional
considerations and complexities around reopening
for good cause.
519 This approach may continue to maintain a
degree of alignment between reopening policies
under the Shared Savings Program and other
Medicare policies. In the February 2016 proposed
rule, in which we proposed amending the Shared
Savings Program’s reopening policy, we referred to
the longstanding policy in the Medicare program
that a determination may be reopened at any time
if it was procured by fraud or similar fault, and as
an example referred to 42 CFR 405.980(b)(3) (see 81
FR 5855). In accordance with § 405.980(b)(3), a
contractor may reopen an initial determination or
redetermination on its own motion at any time if
there exists reliable evidence as defined in
§ 405.902 that the initial determination was
procured by fraud or similar fault as defined in
§ 405.902.
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the Shared Savings Program would
allow us to more timely address the
impact of improper payments on Shared
Savings Program calculations, rather
than waiting to consider the outcome of
any possible appeal of the amounts (as
discussed in section III.G.7.c.(2).(c) of
this proposed rule).
As part of our initial analysis to
evaluate whether to reopen an ACO’s
initial determination, we may also
consider the significance of the
improper payments to an ACO’s
financial calculations by estimating the
financial impact of improper payments
on an ACO’s payment determination. If
we estimate that the improper payments
have impacted the dollar amount of
earned shared savings, or the amount of
shared losses that the ACO owes or has
paid to CMS, we anticipate reopening
an ACO’s payment determination. When
determining whether to reopen an
ACO’s payment determination, we
anticipate considering a combination of
factors including:
• The dollar value of improper
payments and the number of claims or
line items impacted (if applicable).
• How any related impact on
performance year expenditures may
compare to the impact on the ACO’s
updated historical benchmark (which
could include considering the impact on
benchmark year expenditures and
factors used to establish, adjust and
update the benchmark). In particular,
we may consider whether comparing
performance year expenditures to the
updated benchmark expenditures used
in financial reconciliation, once
adjusted to account for the estimated
impact of the improper payments,
would result in a significant change in
the amount of shared savings paid to or
shared losses owed by the ACO. For
purposes of this analysis we may
consider the following:
++ The MSR/MLR applicable to the
ACO for the relevant performance year.
++ Whether the ACO met or exceeded
the applicable MSR/MLR with the
initial determination.
++ Whether accounting for improper
payments would cause a change in the
ACO’s financial performance compared
to its performance under the initial
determination, including:
-- Causing an ACO to meet or exceed
its MSR/MLR when it did not do so
under its initial determination, or no
longer meet or exceed the relevant
threshold when it did so under its
initial determination.
-- Causing an ACO that shared
savings or owed losses under the initial
determination to share in either a higher
or lower amount of savings or losses
(respectively).
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-- Causing an ACO to continue to
generate savings or losses less than the
MSR/MLR threshold, as it did under its
initial determination, and therefore the
ACO would remain ineligible for shared
savings, except in cases where certain
low revenue ACOs participating in the
BASIC track may qualify for a shared
savings payment in accordance with
§ 425.605(h), and would not be held
liable for shared losses.
We note that the existing reopening
authority at § 425.315 and the proposed
financial methodology to address
improper payments in such a reopening
are not intended to address particular
instances of low-value improper
payments which, in an individual case
may be to the benefit of either the ACO
or CMS and in the aggregate are likely
have a de minimis net effect on program
expenditures in the long run.520 CMS
would be highly unlikely to reopen in
such cases under § 425.315. We believe
that considering the significance of the
potential impact of the improper
payments on the ACO’s payment
determination, in deciding whether to
reopen the payment determination, is a
key component of striking a balance
between improving the accuracy of the
calculations and ACOs’ and CMS’
interest in administrative finality of
payment determinations. We discuss
related concerns and considerations
elsewhere in this section of this
proposed rule. Therefore, we would
seek to reopen an ACO’s payment
determination only in cases where the
impact of improper payments warrants
disrupting the initial determination.
Consider, for example, that in our
initial determination we found that an
ACO generated savings below its
minimum savings rate (MSR) and,
therefore, did not qualify for a shared
savings payment according to the
policies for determining the ACO’s
eligibility for shared savings applicable
to its agreement period under the
Shared Savings Program.521 If, based on
an initial analysis, we estimate that the
ACO’s savings, though higher once
adjusted to remove improper payments
from performance year expenditure
calculations, would still fall below the
minimum savings rate, it would not be
necessary to reopen an ACO’s payment
determination because the ACO would
still not qualify for a shared savings
payment. Under such circumstances, we
would not reopen the initial
determination or proceed with the
for example, 81 FR 38000 and 38001.
example assumes a one-sided model ACO
with an MSR based on the number of beneficiaries
assigned to the ACO, or a two-sided model ACO
with an MSR/MLR greater than zero.
PO 00000
520 See,
521 This
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recalculations described in section
III.G.7.c.(2).(c) of this proposed rule. We
anticipate that this particular type of
situation could occur in cases where the
improper payments at issue are
relatively small and the differential
between an ACO’s generated shared
savings and minimum savings rate as
calculated in the initial determination is
relatively large such that recalculating
the amounts would not produce a
different outcome to the payment
determination.
It is also possible that improper
payments would have no impact on
Shared Savings Program financial
calculations as they may consist of
claims or payment amounts that were
not used in reaching the initial
determination of the ACO’s financial
performance. For instance, if a
demanded overpayment determination
was for a payment amount on a claim
with a HCPCS or CPT code identified as
having significant, anomalous, and
highly suspect billing activity, and
therefore the payment amount was
excluded from certain financial
calculations used in determining the
ACO’s financial performance under the
proposed adjustment discussed in
section III.G.7.d of this proposed rule,
we would not include this amount as
part of a reopening for the same
performance year. As another example,
if the demanded overpayment
determination was for a claim or line
item that was initially paid after the end
of the 3-month claims run out period,
we would not take into account through
the reopening process a payment
amount that was not included in Shared
Savings Program calculations to begin
with. We anticipate improper payments
identified in these circumstances would
not merit reopening the ACO’s initial
determination.
A number of steps would follow after
CMS has decided to reopen the initial
determination. We would recalculate
the ACO’s financial performance for a
performance year by applying the
methodology as described in section
III.G.7.c.(2).(c) of this proposed rule.
With this recalculation we would
determine the amount of shared savings
payment the ACO may be eligible to
receive or the amount of shared losses
the ACO may owe for the performance
year after accounting for the impact of
the improper payments. We would issue
a revised initial determination to the
ACO with the recalculated payment
determination for the performance year.
We would notify the ACO of savings
and losses in accordance with
§ 425.604(f), § 425.605(e), § 425.606(h),
§ 425.609(e), or § 425.610(h) (as
applicable). Depending on the outcome
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of the recalculation as specified in the
revised initial determination, we would
engage in payment activities and
recoupment activities, as needed. As
explained in earlier rulemaking, we
anticipate considering ways to minimize
program disruptions for ACOs that
could result from one or more
reopenings (see for example, 81 FR
38001 through 38002; see also, 87 FR
69868 through 69872). CMS may require
considerable time after deciding to
reopen an initial determination before it
can complete the process described
above for a variety of reasons. For
example, additional time may be
necessary for CMS or other agencies to
ascertain the precise amount of
improper payments that affected the
initial determination.
In reopening a payment
determination, we note that improper
payments may impact either
performance year expenditures, the
ACO’s updated historical benchmark
used in determining the ACO’s financial
performance (including calculation of
benchmark expenditures and factors
used to establish, adjust and update the
ACO’s historical benchmark), or both.
The recalculation of the ACO’s financial
performance may have varying effects
on the ACO’s payment determination
for the performance year. In some
scenarios, the recalculation may change
the determination of whether the ACO
earned shared savings or owes shared
losses, or may change the amount of any
shared savings earned or shared losses
owed. It is also possible that we may
observe there is no impact on the
amount of shared savings earned or
amount of shared losses owed by the
ACO, once we have performed the
recalculation of the ACO’s financial
performance.
Under the Shared Savings Program’s
benchmarking methodology, there are
potential interactions between
performance of an ACO under the
program for a performance year during
an agreement period and resetting the
ACO’s benchmark for a subsequent
agreement period. Specifically, an
ACO’s performance year may
correspond to a benchmark year of its
subsequent agreement period, such that
improper payments impacting
expenditures for Medicare FFS
beneficiaries used to determine
performance year expenditures may
similarly impact expenditures for the
same period used to establish the ACO’s
historical benchmark. For instance, for
ACOs that have participated in the
Shared Savings Program over multiple
agreement periods, improper payments
may impact the amount of a prior
savings adjustment to the historical
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benchmark (if applicable).522 We
discussed the complexity around some
related interactions in CY 2024 PFS
rulemaking, in regard to recalculating
the prior savings adjustment, as
described in section III.G.7.c.(1).(b) of
this proposed rule (see 88 FR 79198
through 79200). We note that
reopenings at any time for fraud or
similar fault could extend to any prior
performance year of the Shared Savings
Program. Since Shared Savings Program
policies have changed over time, in
performing the recalculation we would
apply the relevant financial model and
benchmarking policy for the ACO for
that performance year, in accordance
with the applicable provisions of
subpart G.
Third, we are considering limiting the
instances in which we reopen an initial
determination to account for improper
payments, pursuant to § 425.315(a), to
strike a balance between improving the
accuracy of the calculations and ACOs’
and CMS’ interest in administrative
finality of payment determinations. In
rulemaking for the Shared Savings
Program during 2016, we considered
factors for balancing the need to reopen
and correct Shared Savings Program
payment determinations with the need
for administrative finality, which has
implications for both ACOs and CMS
(81 FR 5853 through 5858, and 81 FR
37997 through 38002). Some of these
factors were discussed more generally,
in the February 2016 proposed rule,
with respect to our consideration of
options for further developing our
reopening policy (see, for example, 81
FR 5854 and 5855). We explained that
an approach of correcting even very
minor errors might result in significant
operational burdens for ACOs and CMS,
including multiple financial
reconciliation re-runs and off-cycle
payment/recoupment activities that
could have the potential for significant
and unintended operational
consequences, and could jeopardize the
certainty of performance results for both
ACOs and CMS. We explained our
concern that a relatively broad scope
522 Refer to § 425.658 specifying calculation of the
prior savings adjustment applicable to ACOs in
agreement periods beginning on January 1, 2024,
and in subsequent years. Refer to § 425.603(b)(2)
specifying an additional adjustment is made to the
historical benchmark to account for the average per
capita amount of savings generated during the
ACO’s previous agreement period, implemented for
renewing ACOs entering a second agreement period
in 2016. See the discussion in the CY 2023 PFS
final rule, in which we finalized the prior savings
adjustment applicable for agreement periods
beginning on January 1, 2024, and in subsequent
years, and provided background on, and a
description of, the prior savings adjustment that
applied to certain ACOs in an earlier agreement
period (87 FR 69898 through 69915).
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61897
and extended timeframe for reopening
could introduce financial uncertainty
that could limit an ACO’s ability to
invest in additional improvements to
increase quality and efficiency of care.
This uncertainty could also limit an
ACO’s ability to get a clean opinion
from its financial auditors and/or to
obtain funds from lenders or investors.
We remain especially concerned
about the potential for financial
uncertainty resulting from a broad scope
and extended timeframe for reopening
for ACOs and CMS, particularly if
correcting minor errors resulting from
improper payments. We are concerned
that reopening payment determinations
for minor issues impacting calculations
for one or several performance years of
an ACO’s earlier agreement period
could in turn disrupt the administrative
finality of calculations for multiple
performances years, in one or more
subsequent agreement period, if the
impacted year(s) become benchmark
year(s) used in resetting the ACO’s
historical benchmark. We also note that
since an ACO’s performance can vary
from year to year (in terms of whether
the ACO generates savings or losses and
is eligible for shared savings or owes
shared losses), it is possible for there to
be a mixed effect across reopening
payment determinations for multiple
performance years. If the recalculation
of financial performance identifies
relatively small changes in the amount
of shared savings or shared losses, it
could be possible for these changes to
balance out over a span of multiple
performance years. This raises further
questions about the utility of reopening
payment determinations versus
maintaining administrative finality of
initial determinations.
A relatively straight-forward case
would be to reopen a single
performance year that we identify as
having been impacted by improper
payments. When a performance year for
which we issue a revised initial
determination becomes a benchmark
year of an ACO’s subsequent agreement
period, whether we reopen an ACO’s
payment determination to account for
the impact of improper payments in
Shared Savings Program calculations
would differ depending on whether or
not we have issued an initial
determination for a performance year of
the ACO’s subsequent agreement period.
If the subsequent agreement period is
the ACO’s current agreement period,
and CMS has not yet issued an initial
determination for a performance year
within the current agreement period, we
would account for the impact of
improper payments on future financial
calculations pursuant to the proposed
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benchmark adjustment specified in
modifications to §§ 425.601(a)(9) and
425.652(a)(9). See section III.G.7.c.(2).(d)
of this proposed rule for a discussion of
our proposals related to modifying these
provisions.
CMS’ decision to reopen an initial
determination for a performance year is
independent of a determination by CMS
to reopen an initial determination for
any other performance year, including
in cases where multiple performance
years are impacted by the same
improper payments, whether within the
ACO’s current agreement period, or a
past agreement period. In these
circumstances, we would need to
potentially consider reopening initial
determinations for multiple
performance years, which may span
multiple agreement periods, in cases
where an ACO has continued its
participation in the Shared Savings
Program over time. Therefore, we are
considering applying a combination of
the following factors in determining
whether to reopen an initial
determination: (1) consideration of the
timing of reopening and recalculating
the payment determination for a
performance year, and the timing of
financial reconciliation for one or more
performance year of a subsequent
agreement period that includes the
affected period as a benchmark year,
and (2) consideration of whether the
improper payments result from conduct
of individuals or entities performing
functions or services related to the
ACO’s activities.
Regarding the timing for reopening,
we may consider whether a performance
year that is being reopened corresponds
to a benchmark year of an ACO’s
subsequent agreement period. We may
consider whether we have completed
financial reconciliation for a subsequent
performance year, using a benchmark
that is impacted by the same improper
payments that were accounted for in
reopening a payment determination for
a performance year corresponding to a
benchmark year.
We expect ACOs continuing their
participation over multiple agreement
periods in the Shared Savings Program
have a heightened interest in
administrative finality of payment
determinations, which would provide
greater financial certainty to the
continued operation of ACOs and
progress towards meeting the program’s
goals. In such cases, we believe (1)
reopening payment determinations for a
performance year to account for the
impact of improper payments remains
important to improving the accuracy of
the Shared Savings Program’s
calculations, and (2) maintaining the
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administrative finality of subsequent
payment determinations, if the same
improper payments impact a benchmark
year of an ACO’s subsequent agreement
period, could provide ACOs greater
financial certainty with respect to their
participation which may outweigh the
benefits of reopening the calculations.
Maintaining administrative finality of
the payment determinations for these
subsequent performance years may be
warranted in cases where the improper
payments are not a result of the conduct
of individuals or entities within the
ACO. On the other hand, in cases where
improper payments impacting Shared
Savings Program calculations results
from conduct by individuals or entities
within the ACO, CMS’ interest in
addressing program integrity concerns
would warrant reopening all affected
payment determinations. In these cases,
if left unaddressed, ACOs, ACO
participants and ACO providers/
suppliers, among others, may have
incentives to continue to engage in
conduct, which could include fraud or
similar fault, in a way that could
improve the ACO’s performance under
the Shared Savings Program.
Although not expressly stated in
§ 425.315, we note that improper
payments that are the basis of a
reopening may result from the conduct
of individuals or entities including but
not limited to: (1) conduct of an ACO,
ACO participant, ACO provider/
supplier, ACO professional, or other
individuals or entities performing
functions or services related to the
ACO’s activities; or (2) conduct of a
provider or supplier, or other
individuals or entities outside the ACO.
For purposes of the discussion within
this section of this proposed rule, we
refer to the former as improper
payments originating ‘‘inside the ACO’’,
and the latter as improper payments
originating ‘‘outside the ACO’’.
To follow is a brief summary of the
approach we are considering for
differentiating between cases where
improper payments originate inside the
ACO versus outside the ACO. If we
identify a single performance year for
which we have issued an initial
determination that has been impacted
by improper payments, we would seek
to reopen the payment determination if
the improper payments originated either
inside the ACO or outside the ACO.
When a performance year for which
we issue a revised initial determination
becomes a benchmark year of an ACO’s
subsequent agreement period, we would
consider whether to reopen each initial
determination for a subsequent
performance year that is impacted. We
are considering taking the following
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approach as one means to operate
reopenings in an equitable and
manageable manner:
• In cases where improper payments
originated outside the ACO: Generally,
we would not seek to reopen payment
determinations for any performance
year of the ACO’s subsequent agreement
period in order to mitigate the extent to
which we disrupt the administrative
finality of payment determinations for
ACOs when the improper payments
impacting Shared Savings Program
calculations originate outside the ACO.
However, we may consider reopening
the initial determination for the
performance year upon the ACO’s
request for a reopening if the improper
payments are anticipated to result in
significant adjustment to the ACO’s
initial determination upon
recalculation.
• In cases where improper payments
originated inside the ACO: As a means
to address our program integrity
concerns, we would reopen the payment
determination for any performance year
of the ACO’s subsequent agreement
period issued prior to the revised initial
determination for the performance year
corresponding to the benchmark year
impacted by improper payments
originating inside the ACO, if the
improper payments are anticipated to
result in significant adjustment to the
ACO’s initial determination upon
recalculation. We believe this approach
would guard against circumstances
where an ACO may benefit from
improper payments remaining in its
benchmark calculations that result from
conduct by individuals or entities
performing functions or services related
to the ACO’s activities.
We seek comment on the factors we
have described in this section of this
proposed rule, that may inform our
decision of whether to reopen an initial
determination of an ACO’s financial
performance to account for the impact
of improper payments. In particular, we
seek comment on the approach we
outlined for conducting initial analysis
of whether the improper payments
would warrant reopening the ACO’s
payment determination. We also seek
comment on approaches to, and
considerations in connection with,
balancing the need for accuracy in
payment calculations with the need for
administrative finality in payment
determinations.
(c) Methodology for Recalculating
Expenditures To Account for Improper
Payments
We propose to establish a financial
calculation methodology that may be
used to account for the impact of
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improper payments on Shared Savings
Program financial calculations, upon
reopening a payment determination
pursuant to § 425.315(a). We propose to
add to subpart G a new section of the
Shared Savings Program regulation at
§ 425.674 specifying provisions on
accounting for the impact of improper
payments on Shared Savings Program
financial calculations.
As a general rule, we propose to
specify in paragraph (a) of § 425.674,
that upon the reopening of an initial
determination pursuant to
§ 425.315(a)(4), CMS will use the
methodology set forth in § 425.674 to
account for the impact of improper
payments when: (1) determining savings
or losses for the relevant performance
year in accordance with § 425.315 in
order to issue a revised initial
determination, and (2) adjusting the
benchmark by recalculating benchmark
year expenditures in the event that we
recalculate a payment determination
and issue a revised initial determination
for the corresponding performance year
in a prior agreement period (as
discussed in section III.G.7.c.(2).(d) of
this proposed rule).
We propose to specify in paragraph
(b) of § 425.674 that for the purpose of
the Shared Savings Program, ‘‘improper
payment’’ includes: (1) an amount
associated with a demanded
overpayment determination, and (2) an
amount identified in a settlement
agreement or judgment, pursuant to
conduct of individuals or entities
performing functions or services related
to an ACO’s activities, less any penalties
or damages.
We propose to establish a
methodology under § 425.674 under
which we would adjust Medicare Parts
A and B FFS expenditure values used in
certain Shared Savings Program
financial calculations to account for a
per capita amount of improper
payments for an identified population
used in calculating performance year or
benchmark year expenditures, and in
calculating county-level FFS
expenditures used in factors based on
regional expenditures.
We propose to specify under
§ 425.674 a generalized approach to
calculating the per capita amounts of
improper payments that accounts for the
fact that improper payments may be
associated with specific claims or line
items, or may be aggregate amounts. A
number of factors informed our
consideration of this approach. For one,
we considered the need to establish a
calculation methodology to account for
demanded overpayment determinations
that result in adjustments to payment
amounts associated with claims and line
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items used in Shared Savings Program
calculations, such as the denial of
claims or line items that occur after the
3-month claims run out period, or in an
aggregate amount, such as based on
extrapolated overpayment demands that
do not result in adjustments to claim or
line item payment amounts. Medicare
Parts A and B FFS claim adjustments for
overpayments would be reflected in
current Shared Savings Program
expenditure calculations if processed
before the end of the 3-month claims
run out period but are not included in
calculations if processed after the 3month claims run out period. Regarding
the latter, the amounts of the claims
adjusted overpayments can be identified
for Medicare FFS beneficiaries, and can
be aggregated across a population of
Medicare FFS beneficiaries that is the
basis for certain Shared Savings
Program calculations. Additionally,
aggregate amounts of demanded
overpayment determinations, such as
extrapolated overpayment demands,
may be used to identify the amount of
improper payments for a large set of
claims for a particular provider or
supplier and a certain time period, since
error rates are extrapolated and applied
to a universe of claims rather than
individual claims. In these cases, an
aggregate amount of a demanded
overpayment determination is
attributable to a provider or supplier
and would have to be further prorated
to determine its relevance to a particular
population of Medicare FFS
beneficiaries that is the basis for certain
Shared Savings Program calculations.
Second, we considered the need for
the calculation methodology to account
for improper payments resulting from
conduct by an ACO, ACO participant,
ACO provider/supplier, ACO
professional, or other individuals or
entities performing functions or services
related to the ACO’s activities identified
in certain settlements, or judgments.
With respect to the Shared Savings
Program calculations, we anticipate that
a key focus would be on improper
payments pursuant to conduct of
individuals or entities performing
functions or services related to an
ACO’s activities as identified in certain
False Claims Act (31 U.S.C. 3729 et seq.)
settlement agreements, or judgments. In
considering the amount of improper
payments that are relevant to Shared
Savings Program calculations, we would
exclude the amount of any penalties or
damages included in the settlement or
judgment. In addition, we may seek to
attribute an aggregate improper payment
amount to a provider or supplier that is
specified within a settlement agreement,
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61899
or judgment, across a population of
Medicare FFS beneficiaries that is the
basis for the applicable Shared Savings
Program calculation.
Further, we anticipate there may be
circumstances that warrant adjustment
to payment amounts used in Shared
Savings Program calculations, at the
claims level, instead of or in addition to
accounting for the amount of demanded
overpayment determinations or an
aggregate amount in a settlement
agreement or judgment. For instance, in
analyzing improper payments impacting
Shared Savings Program calculations,
we may conclude that a provider’s or
supplier’s billings for a particular
HCPCS or CPT code for a population of
Medicare FFS beneficiaries resulted in
inaccuracies in payment amounts used
in Shared Savings Program calculations.
We propose that we may address these
circumstances by decreasing or entirely
removing the value of HCPCS or CPT
code payment amounts for certain
claims or line items used in Shared
Savings Program calculations, in
reopening and recalculating the ACO’s
payment determination. We anticipate
using all information available to us
from an investigation, settlement
agreement, or judgment to determine the
correct payment amount or level of
billing. This could include considering
the nature of the remedy in the case and
how any related amount would be
applied in the proposed methodology to
account for improper payments
impacting Shared Savings Program
financial calculations. In particular, we
would consider if it would be a more
precise adjustment to Shared Savings
Program financial calculations to adjust
the claim or line item payment amounts,
instead of or in addition to accounting
for the amount of demanded
overpayment determinations or an
aggregate amount in a settlement
agreement or judgment (if applicable).
For instance, in cases where an
investigation, settlement agreement, or
judgement has determined inaccurate
use of a higher paying code 523 that is
reflected in payment amounts used in
Shared Savings Program calculations,
we may identify use of a code with
lower reimbursement within a HCPCS
or CPT code category that would result
523 See, for example, CMS, Medicare Claims
Processing Manual Chapter 23—Fee Schedule
Administration and Coding Requirements, section
20.9.5 ‘‘Adjustments’’, available at https://
www.cms.gov/regulations-and-guidance/guidance/
manuals/downloads/clm104c23.pdf (explaining
that if the wrong, higher paying code is paid on the
first of multiple claims submitted, A/B MACs
processing Medicare Part B claims pay the
subsequent claim(s) and initiate recovery action on
the previously paid claim(s)).
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in a more precise adjustment to the
ACO’s payment determination.
We propose to specify in paragraphs
(c) and (d) of § 425.674 the general
approach for adjusting Medicare Parts A
and B FFS expenditures for improper
payments, according to the following
steps:
• Step 1—Identify calculation for
adjustment: Identify each Shared
Savings Program expenditure
calculation for a performance year or
benchmark year, as calculated according
to the standard methodology described
in subpart G and expressed as a per
capita dollar amount, that would be
adjusted for the impact of improper
payments (as proposed in
§ 425.674(c)(1)).
• Step 2—Determine the relevant
population for adjustment: Determine
each specific population of Medicare
FFS beneficiaries used to calculate the
expenditure amount identified in Step
1, expressed as person years (as
proposed in § 425.674(c)(2)). The
populations relevant for a specific
expenditure calculation may include:
++ The population of beneficiaries
assigned to the ACO for calculating the
ACO’s performance year or benchmark
year expenditures.
++ The population of assignable
beneficiaries in each county in the
ACO’s regional service area for
calculating county-level expenditures.
++ The national population of
assignable beneficiaries for calculating
national assignable expenditures.
++ The national population of
Medicare FFS beneficiaries for
calculating national expenditures.
• Step 3—Determine per capita
amount of improper payments
attributable to the relevant population:
Determine the per capita amount of
improper payments for the performance
year or benchmark year included in the
per capita Medicare Parts A and B FFS
expenditure amount for a population
identified in Step 2 (as proposed in
§ 425.674(c)(3)). We may use one or
more of the following approaches to
determine the per capita amount of
improper payments, for all providers or
suppliers with improper payments, that
would be used to adjust the expenditure
calculations identified in Step 1 (as
proposed in § 425.674(d)):
++ Step 3(i): Calculate aggregate
improper payments attributable to a
population identified in Step 2 for each
provider or supplier that had improper
payments.
--For improper payments associated
with specific claims, we would do the
following:
(A) For improper payments to a
provider or supplier that correspond to
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payment amounts on claims or line
items that were used in a Shared
Savings Program calculation identified
in Step 1, and subsequently adjusted
after the 3-month claims run out period,
we would sum the improper payment
amounts across all such claims or line
items with dates of service during the
period used to calculate performance
year or benchmark year expenditures,
for a population identified in Step 2.
To allow for this approach, we
propose to adjust Shared Savings
Program expenditure calculations to
reflect adjustments occurring after the
original 3-month claims run out period
for claim or line item payment amounts
associated with improper payments. We
would not capture payments or payment
adjustments occurring outside the
original 3-month claims run out period
for claims or line items unrelated to
improper payments.
(B) In the event that CMS determines
it is necessary to account for the impact
of improper payments on Shared
Savings Program financial calculations
by adjusting the payment amounts for a
specific HCPCS or CPT code billed by
the provider or supplier for the
population identified in Step 2, we
would do the following: identify the
applicable claims or line items with
dates of service during the period used
to calculate performance year or
benchmark year expenditures processed
before the end of the applicable 3-month
claims run out period, and sum the
claim or line item payment amounts on
the claims or line items identified; and
if applicable, multiply the resulting sum
by a scaling factor to compute the
payment differential between the
HCPCS or CPT code that was
improperly billed and a CMS-identified
alternate code. We would apply a
scaling factor in cases where it is
determined that the provider or supplier
did not bill the correct code for a
particular service. In cases where we
determine it is appropriate to remove
payments for the billed HCPCS or CPT
code in their entirety, we would not
apply a scaling factor.
--For aggregate improper payment
amounts that are not linked to specific
claims or line items, we would calculate
the amount attributable to the
population identified in Step 2 by
applying a proration factor to the
aggregate improper payment amount
identified for that provider or supplier.
We would calculate the proration factor
as follows:
(A) The denominator of the proration
factor would be total Medicare Parts A
and B claim or line item payment
amounts to the provider or supplier for
all FFS beneficiaries on claims of
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specified claim types for the time period
associated with the aggregate improper
payment amount identified for the
provider or supplier that were made
before the end of the applicable 3-month
claims run out period.
(B) The numerator of the proration
factor would be the portion of the total
from the denominator that CMS
determines is attributable to the
population identified in Step 2 with
dates of service during the period used
to calculate expenditures for the
applicable performance year or
benchmark year.
Under this proposed approach, if an
aggregate amount of improper payment
is associated with claims activity that
spans multiple calendar years, we
would account for this in the proration
factor by expanding the time period
used to compute payments for the
denominator to include the relevant
years. For example, if the aggregate
amount of improper payments was
associated with claims activity in 2021
and 2022, we would include in the
denominator payments on claims or line
items with dates of service in 2021
(made before the end of March 2022)
and on claims or line items with dates
of service in 2022 (made before the end
of March 2023). If we were adjusting PY
2022 expenditures for an ACO’s
assigned population, the numerator of
the proration factor would be the
portion of the denominator that is
attributable to the ACO’s assigned
population during CY 2022.
++ Step 3(ii): Sum the amounts
calculated under Step 3(i) attributable to
the population identified in Step 2
across providers or suppliers that had
identified improper payments.
++ Step 3(iii): Take the lesser of the
following two values:
--The sum from Step 3(ii); or
--Total Medicare Parts A and B claim
or line item payment amounts to all
providers or suppliers that had
improper payments for the population
identified in Step 2 on claims of
specified claim types with dates of
service within the performance year or
benchmark year made before the end of
the applicable 3-month claims run out
period.
The purpose of taking the lesser of
two values in this step is to ensure that
the improper payment amount that we
attribute to a given population cannot be
greater than the total amount of
payments for the providers or suppliers
at issue that was included in the
original expenditure calculation for that
population.
++ Step 3(iv): Express the lesser-ofamount from Step 3(iii) as a per capita
value by dividing by the total
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beneficiary person years in the
population identified in Step 2 for the
applicable performance year or the
benchmark year.
• Step 4—Subtract per capita
improper payment amount from original
expenditures: From the expenditure
calculation identified in Step 1 for the
population identified in Step 2, subtract
the per capita amount calculated in Step
3(iv) 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 proposed in
§ 425.674(c)(4)).
• Step 5—Determine adjusted
regional expenditures: If applicable, we
would do the following to adjust
regional expenditures for improper
payments (as proposed in
§ 425.674(c)(5)):
++ Step 5(i): Adjust county-level FFS
expenditures determined in Step 4, for
each county in the ACO’s regional
service area, for severity and case mix
of assignable beneficiaries in the county
using prospective HCC risk scores. This
calculation would be for each of the
following populations of beneficiaries
based on Medicare enrollment type:
ESRD, disabled, aged/dual eligible
Medicare and Medicaid beneficiaries,
and aged/non-dual eligible Medicare
and Medicaid beneficiaries. We note
that under this approach CMS would
not adjust the risk scores used to
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calculate risk adjusted county-level FFS
expenditures.
++ Step 5(ii): Weight the risk-adjusted
county-level FFS expenditures
determined in Step 5(i) according to the
ACO’s proportion of assigned
beneficiaries in the county, determined
in accordance with § 425.601(d)(1),
§ 425.603(f)(1), or § 425.654(b)(1), as
applicable, for each of the populations
of beneficiaries by Medicare enrollment
type.
++ Step 5(iii): Aggregate the values
determined in Step 5(ii) for each of the
populations of beneficiaries (by
Medicare enrollment type) across all
counties within the ACO’s regional
service area.
To illustrate how the proposed
calculation methodology would be
applied, we can consider the following
hypothetical example in which CMS
confirmed that two suppliers, NPI 1 and
NPI 2, received improper payments
from Medicare during calendar year
2022. Specifically, CMS identified $8
million in demanded overpayment
determinations for NPI 1 which resulted
in CMS adjusting payment amounts
after the 3-month claims run out period
for PY 2022 on claims or line items with
dates of service during the performance
year, and CMS identified an aggregate
extrapolated overpayment demand
amount of $30 million for NPI 2.
Assume that in this example, CMS
determines that reopening the ACO’s PY
2022 initial determination is warranted,
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61901
and CMS recalculates that ACO’s
financial performance using the
proposed methodology to account for
improper payments. To recalculate the
ACO’s financial performance for PY
2022, we would identify three separate
expenditure calculations that need to be
recalculated to determine the impact on
an ACO’s earned performance payment
or owed shared losses: (1) PY 2022
expenditures for the ACO’s assigned
beneficiaries; (2) PY 2022 expenditures
for assignable beneficiaries in the ACO’s
regional service area; and (3) PY 2022
expenditures for national assignable
beneficiaries. For this example, in Table
41 we outline the steps and calculations
for recalculating expenditures for
beneficiaries assigned to the ACO for PY
2022. In Table 42 we outline how PY
2022 expenditures for assignable
beneficiaries in the ACO’s regional
service area and PY 2022 expenditures
for national assignable beneficiaries,
recalculated to account for improper
payments, would be incorporated into
the blended national-regional
benchmark update factor. In Table 43
we outline how an ACO’s financial
performance may be recalculated after
accounting for improper payments in
PY 2022 expenditures for the ACO’s
assigned beneficiaries, and using the
recalculated blended national-regional
benchmark update factor.
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TABLE 41: Hypothetical Example of Steps for Recalculating ACO Assigned Beneficiary
Expenditures Using Proposed Methodolo!!V to Account for Improper Payments
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In Step 1, we identify expenditures
for the ACO’s assigned beneficiaries in
PY 2022 as the calculation to be
recalculated. In Step 2, we identify the
ACO’s assigned beneficiaries in PY 2022
as the population relevant for this
expenditure calculation. In Step 3, we
determine the per capita amount of
improper payments that is attributable
to the ACO’s assigned beneficiaries. For
NPI 1, we identify that $200,000 of the
NPI’s total aggregate improper payments
were on claims for the ACO’s assigned
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beneficiaries (row [D]). Because
improper payments for NPI 2 were
identified at the NPI level and thus are
not tied to individual claims, we need
to apply a proration factor to calculate
the share of the total aggregate improper
payments, $30 million (row [E]), that is
attributable to the ACO’s assigned
beneficiaries. We calculate this
proration factor as the total Medicare
Parts A and B claim or line item
payment amounts made to NPI 2 for the
ACO’s assigned beneficiaries for PY
2022 ($4.8 million, row [F]), divided by
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the total Medicare Parts A and B claim
or line item payment amounts made to
NPI 2 for all Medicare FFS beneficiaries
($80 million, row [G]); this results in a
proration factor of 0.06 (row [H]), which
when applied to NPI 2’s total aggregate
improper payments results in $1.8
million in aggregate improper payments
attributable to the ACO’s assigned
beneficiaries (row [I]). Summing across
NPI 1 and NPI 2, we calculate $2
million in total aggregate improper
payments attributable to the ACO’s
assigned beneficiaries for PY 2022 (row
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EP31JY24.070
Amount
Steps 1 and 2: Identify calculation and relevant population for adjustment
ACO PY assigned beneficiary expenditures by enrollment type (per capita) rA l
ESRD
$80,000
Disabled
$11,000
Aged/dual
$15,000
Aged/non-dual
$12,000
ACO PY total assigned beneficiarv person years rBl
20,000
Step 3: Determine per capita amount of improper payments attributable to the relevant population
Aggregate improper payments attributable to the ACO's assigned beneficiaries for NPI
1 (identified at the claim or line item level)
Total aggregate improper payments for NPI I rel
$8,000,000
Aggregate improper payments for NPI I attributable to the ACO's assigned
$200,000
beneficiaries rDl
Aggregate improper payments attributable to the ACO's assigned beneficiaries for NPI
2 (identified at the NPI level)
$30,000,000
Total aggregate improper payments for NPI 2 rEl
Total Medicare Parts A and B claim or line item payment amounts to NPI 2 for the
$4,800,000
ACO's assigned beneficiaries for PY (a portion of row ran rFl
$80,000,000
Total Medicare Parts A and B claim or line item payment amounts to NPI 2 for all
Medicare FFS beneficiaries, on claims of specified claim types for the time
period associated with improper payment amount, made before the end of the 3month claims run out period for PY ral
Proration factor rm= rFl / rGl
0.06
Aggregate improper payments attributable to the ACO's assigned beneficiaries [I]
$1,800,000
= [E] x [H]
Sum of improper payments attributable to the ACO's assigned beneficiaries for NPI 1
$2,000,000
and NPI 2 rJl = rDl + r1l
Total Medicare Parts A and B claim or line item payment amounts to NPI I and NPI 2
$5,200,000
for the ACO's assigned beneficiaries made before the end of the 3-month claims run
out period for PY [K]
Total aggregate improper payments attributable to the ACO's assigned beneficiaries
$2,000,000
rLl = Lesser of rJl and rK l
$100
Per capita improper payments attributable to the ACO's assigned beneficiaries [M] =
[L] / [B]
Step 4: Subtract per capita improper payment amount from orie:inal expenditures
Adjusted ACO PY assigned beneficiary expenditures by enrollment type (per capita)
[N] = [A] - [M]
ESRD
$79,900
Disabled
$10,900
Aged/dual
$14,900
Aged/non-dual
$11,900
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[J]). We then compare this sum (row [J])
with total Medicare Parts A and B claim
or line item payment amounts to the
two suppliers for the ACO’s assigned
beneficiaries for PY 2022 (row [K]) and
take the lesser of the two values (row
[L]). We then express this lesser-of value
in per capita terms by dividing by the
ACO’s total assigned beneficiary person
years for PY 2022, 20,000, arriving at a
$100 per capita improper payment
amount attributable to the ACO’s
assigned beneficiaries (row [M]).
Finally, in Step 4, we subtract the $100
per capita improper payment amount
from the original PY 2022 per capita
expenditure amount for the ACO’s
assigned beneficiaries used to make the
initial payment determination,
conducting this adjustment by
enrollment type (row [N]).
We note that subtracting the same per
capita improper payment amount ($100
in this example) from the expenditure
calculation for each enrollment type
population implicitly assumes that
improper payments attributable to the
overall population are distributed in
proportion to the four enrollment types
(ESRD, disabled, aged/dual eligible,
aged/non-dual eligible). For example, if
the aged/non-dual eligible population
represents 82 percent of an ACO’s
overall assigned population for the
performance year, we are assuming that
82 percent of improper payments
attributable to the ACO’s entire assigned
population are associated with aged/
non-dual eligible beneficiaries. We
believe that this is a reasonable
assumption as we expect that, in most
cases, improper payments are unlikely
to be associated with a particular
enrollment type as defined by the
Shared Savings Program and used in
program financial calculations.524 This
also allows for a standard approach
across the potential variety of reopening
scenarios, lending greater transparency
and simplicity to the proposed
methodology.
We would follow the same overall
methodology to account for the impact
of improper payments in recalculating
PY 2022 expenditures for assignable
beneficiaries in the ACO’s regional
service area and for national assignable
beneficiaries. These amounts are
calculated for the following 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. We would
then use these adjusted expenditure
calculations as new inputs along with
other original calculations that were not
adjusted for the impact of improper
payments (such as the ACO’s historical
benchmark for PY 2022) to recalculate
the ACO’s financial performance for PY
2022, following the standard financial
methodology described in § 425.605 (for
ACOs participating in the BASIC track)
or § 425.610 (for ACOs participating in
the ENHANCED track), as applicable.
In Table 42, we expand upon the
hypothetical example described in
Table 41 and summarize how we would
calculate national and regional update
factors following the methodology
specified in § 425.652(b)(2) but using
the adjusted regional and national
expenditures for the performance year
for each enrollment type in place of the
original values. Because benchmark
update factors are calculated by
enrollment type under the standard
financial methodology, they would also
be recalculated by enrollment type
when using the adjusted national and
regional expenditures. However, for
brevity, we describe only the
recalculation of the update factors for
the aged/non-dual eligible population in
Table 42.
In this continued hypothetical
example, we used the proposed
methodology to account for the impact
of improper payments in recalculating
national and regional per capita
expenditures in the performance year,
resulting in adjusted expenditures of
$11,609 (row [A]) and $11,210 (row [C]),
respectively. Dividing these PY values
by the original BY3 national and
regional per capita expenditures
($10,977, row [A], and $10,900, row [C],
respectively), we recalculate the
national update factor (1.058, row [B])
and regional update factor (1.028, row
[D]). In this example, there is a $1
difference between the original and
recalculated national per capita
expenditure amount. The resulting
value for the recalculated national
update factor, shown rounded to the
third decimal place, remains the same
as the original value, but there would be
a difference in the values if additional
precision was shown. We then blend
these adjusted update factors using the
original national and regional weights
(0.250, row [E], and 0.750, row [F],
respectively). As shown in row [G],
accounting for improper payments in
PY 2022 causes the blended benchmark
update factor to decrease from 1.042 to
1.036.
BY3
$10,977
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National per capita expenditures rAl
National update factor rBl = rAlrY / rAfoy3
Regional per capita expenditures rel
Regional update factor rDl = rciry / rclBY3
National weight rEl
Regional weight rFl
National-regional blended update factor [G] = [B] x [E] +
ro1 x rFl
$10,900
PY (Ori!!inal)
$11,610
1.058
$11 300
1.037
0.250
0.750
PY (Adiusted)
$11,609
1.058
$11,210
1.028
0.250
0.750
1.042
1.036
Table 43 summarizes how
recalculated blended update factor to
account for improper payments, based
on adjusted national and regional
expenditures for PY 2022, would be
used with other original calculations
524 For criteria used to identify the four Medicare
enrollment types, refer to the 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-and-assignment-
methodology-specifications.pdf-2 (Appendix E:
Identifying Medicare Enrollment Type).
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TABLE 42: Hypothetical Example of How the Blended National-Regional Benchmark
Update Factor for the Aged/Non-Dual Eligible Enrollment Type May Be Recalculated After
Accounting for Improper Payments
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and adjusted PY expenditures for ACO
assigned beneficiaries to recalculate the
ACO’s financial performance for PY
2022. Applying the blended update
factor (row [B]) to the original historical
benchmark values by enrollment type
(row [A]), we recalculate the updated
benchmark values by enrollment type
(row [C]) that account for improper
payments occurring in PY 2022. The
adjusted updated benchmark values
(row [C]) and adjusted PY expenditures
for ACO assigned beneficiaries by
enrollment type (row [D]), also
described in Table 41, are multiplied by
original PY assigned beneficiary
proportions by enrollment type (row
[E]), and summed across enrollment
types to recalculate the per capita
updated benchmark (row [F]) and per
capita ACO PY assigned beneficiary
expenditures (row [G]). We then express
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these per capita quantities as the total
updated benchmark amount (row [I])
and the total ACO PY assigned
beneficiary expenditures amount (row
[J]) by multiplying the per capita dollar
amount by the ACO’s total assigned
beneficiary person years for PY 2022
(row [H]). The recalculated total
updated benchmark (row [I]) can then
be used to recalculate the minimum
savings rate/minimum loss rate dollar
threshold (row [L]). We subtract the
recalculated total ACO PY assigned
beneficiary expenditures (row [J]) from
the recalculated total updated
benchmark (row [I]) to determine if the
ACO has gross savings or gross losses.
Under this example, the recalculation
indicates the ACO has total gross
savings (row [K]). Finally, because the
recalculated total gross savings (row [K])
is greater than the recalculated
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minimum savings rate dollar threshold,
we recalculate the ACO’s shared savings
(row [N]) by multiplying the total gross
savings (row [K]) by the original sharing
rate (row [M]).
The result of these calculations is an
adjusted shared savings amount of
$17,355,000 (before accounting for
sequestration), compared to an original
amount of $16,950,000. Thus, while
adjustments for improper payments
reduced the ACO’s PY assigned
beneficiary expenditures by $2 million,
the impact on the ACO’s recalculated
shared savings is only $405,000 due to
the impact of improper payments on the
expenditures for assignable beneficiaries
that factor into the ACO’s recalculated
updated benchmark for PY 2022.
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TABLE 43: Hypothetical Example of How an ACO's Financial Performance May Be
Recalculated After Accountin2 for Improper Payments
Original
BILLING CODE C
Under the proposed financial
methodology, accounting for the impact
of improper payments on expenditures
could increase or decrease an ACO’s
amount of shared savings or shared
losses. As demonstrated in the
hypothetical example, the direction of
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$89,200
$12,700
$17,700
$12,200
1.007
1.028
1.043
1.042
1.006
1.022
1.039
1.036
-0.001
-0.006
-0.004
-0.006
$89,824
$13,056
$18,461
$12,712
$89,735
$12,979
$18,390
$12,639
-$89
-$77
-$71
-$73
$80,000
$11,000
$15,000
$12,000
$79,900
$10,900
$14,900
$11,900
-$100
-$100
-$100
-$100
0.010
0.100
0.070
0.820
$13,920
$13,847
-$73
$12,790
20,000
$278,400,000
$12,690
-$100
$276,940,000
-$1,460,000
$255,800,000
$253,800,000
-$2,000,000
$22,600,000
$23,140,000
$540 000
$5 568 000
75%
$16,950,000
$5,538,800
-$29 200
$17,355,000
$405 000
changes to an ACO’s shared savings or
shared losses would depend on the
differential impact of improper
payments on the ACO’s assigned
beneficiary expenditures compared to
the impact on expenditures for
assignable beneficiaries used to
determine the national and regional
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Adjusted
Minus
Original
updates to the ACO’s benchmark. In this
example, the reduction in ACO PY
assigned beneficiary expenditures due
to the adjustment for improper
payments was larger than the reduction
to the updated benchmark stemming
from adjustments to PY national and
regional expenditures, ultimately
E:\FR\FM\31JYP2.SGM
31JYP2
EP31JY24.072
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Historical benchmark by enrollment type (risk adjusted, per
capita) [A]
ESRD
Disabled
Aged/dual
Aged/non-dual
National-regional blended update factor by enrollment type
[B]
ESRD
Disabled
Aged/dual
Aged/non-dual
Updated benchmark by enrollment type (per capita) [C] =
rA1 x rB1
ESRD
Disabled
Aged/dual
Aged/non-dual
ACO PY assigned beneficiary expenditures by enrollment
type (per capita) rDl
ESRD
Disabled
Aged/dual
Aged/non-dual
ACO PY assigned beneficiary proportions by enrollment
type rEl
ESRD
Disabled
Aged/dual
Aged/non-dual
Updated benchmark (per capita) ffl = Sum of rc1 x rEl
ACO PY assigned beneficiary expenditures (per capita) [G]
= Sum of [D] x [E]
ACO PY total assigned beneficiary person years [H]
Total updated benchmark [I]= [F] x [H]
Total ACO PY assigned beneficiary expenditures [J] = [G] x
[H]
Total updated benchmark expenditures minus Total ACO PY
assigned beneficiary expenditures [K] = [I] - [J] (example
showing gross savings)
Minimum savings rate I Minimum loss rate in dollars [L] =
0.02 X rll
Sharing rate rMl
Shared savings rNl = rKl X rMl
Adjusted
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causing the ACO to see an increase in
both gross savings and shared savings.
Other ACOs for which the reduction in
ACO PY assigned beneficiary
expenditures is greater than the
reduction to the updated benchmark,
may switch from earning no shared
savings to earning shared savings or
may see a reduction in shared losses
owed. However, if accounting for
improper payments results in relatively
larger reductions to the expenditures for
assignable beneficiaries in the ACO’s
regional service area or in the national
assignable population, and relatively
smaller reductions to the ACO’s PY
assigned beneficiary expenditures, the
ACO might observe a reduction in
shared savings or increase in shared
losses, or potentially cause the ACO to
switch from earning shared savings to
not earning any shared savings or to
owing shared losses.
As we propose in section
III.G.7.c.(2).(d) of this proposed rule, if
the reopened PY becomes a BY for a
subsequent agreement period, CMS
would adjust the historical benchmark
to be used for any PY in that subsequent
agreement period that has not yet been
reconciled. Accounting for improper
payments as it affects the ACO’s
benchmark could then result in changes
to the ACO’s shared savings or shared
losses for a future performance year that
differ in direction compared to the
change in shared savings or shared
losses observed with the initial
reopening that affected PY
expenditures. That is, following the
example from Table 43, accounting for
improper payments occurring in
calendar year 2022 might result in the
ACO earning greater shared savings (or
smaller shared losses) for PY 2022
(because the reduction in ACO PY
assigned beneficiary expenditures
outweighs the reduction in national and
regional expenditures used to update
the benchmark), but may result in
smaller shared savings (or greater shared
losses) for future performance years for
which CY 2022 becomes a benchmark
year (because the adjustment for
improper payments in BY 2022 causes
a reduction in the overall benchmark
with no corresponding reduction to
ACO PY expenditures).
As we described in section
III.G.7.c.(2).(b) of this proposed rule,
administrative action and judicial action
leading to the identification of improper
payments may be subject to appeal, and
ultimately the amount of the improper
payments may be redetermined or
otherwise amended. We acknowledge
the potential inaccuracy in using
amounts of improper payments that may
be reversed, in whole or in part, in
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recalculating an ACO’s financial
performance. However, waiting for each
possible appeal to be raised and
resolved with respect to improper
payments could delay our ability to
reach a determination of whether to
reopen an ACO’s payment
determination, identify the amounts of
improper payments to be used in the
recalculation, or both. We considered
whether to account for the possibility
that the improper payment amounts
would be appealed, and the amount
redetermined, as part the proposed
methodology, but are not proposing a
related approach at this time. For
instance, we considered whether to
apply an adjustment factor as part of the
methodology, that would reduce the
amount of improper payments by a
percentage, to account for the rate at
which the amounts could change, and to
base this rate on statistics gathered on
the outcomes of Medicare Parts A and
B administrative appeals processes.
Given that the proposed approach, if
finalized, would be the initial use of
improper payment amounts in Shared
Savings Program calculation, we note
our intent to monitor for the impact of
appeals on the amounts of improper
payments that may be used in
reopenings under the Shared Savings
Program. We may revisit our approach
in future notice and comment
rulemaking, after we gain additional
experience with using improper
payment amounts in Shared Savings
Program calculations.
We propose to use our authority
under section 1899(d)(1)(B)(ii) of the
Act to calculate benchmark year
expenditures using the proposed
methodology to account for the impact
of improper payments. This provision
authorizes the Secretary to adjust the
benchmark for beneficiary
characteristics and ‘‘such other factors
as the Secretary determines
appropriate’’. When reopening an initial
determination for a performance year
pursuant to § 425.315, we consider it
appropriate to account for the impact of
improper payments on expenditures
used to establish the ACO’s historical
benchmark, consistent with our
proposal.
We propose to use our authority
under section 1899(i)(3) of the Act to
use the proposed methodology to
account for the impact of improper
payments in calculating performance
year expenditures and calculating the
historical benchmark update factors.
CMS may only adopt an alternative
payment methodology pursuant to
section 1899(i)(3) of the Act if we
determine that the alternative payment
methodology will improve the quality
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and efficiency of items and services
furnished to Medicare beneficiaries,
without resulting in additional program
expenditures.
The proposed adjustments would
remove improper payments from the
performance year expenditures and
factors used to calculate updated
historical benchmarks, among other
financial calculations, that resulted in
inaccuracies in an ACO’s payment
determination, including the amount of
shared savings CMS paid an ACO or the
amount of shared losses owed to CMS
by an ACO participating under a twosided model. These policies improve the
accuracy of financial calculations by
which ACOs are held accountable for
the cost and quality of care for their
assigned beneficiary populations.
Addressing the impact of improper
payments on ACO payment
determinations could serve as a
mechanism to bolster program integrity.
ACO accountability for the total cost of
care can deter fraud, waste, and abuse
that is otherwise under the control of
ACO participants. Additionally, ACOs
have unique insight into Medicare Part
A, B, and D claims data for their
assigned beneficiary populations from
monthly claim and claim line level data
ACOs receive from CMS for care
coordination and quality improvement.
This vantage point makes ACOs
uniquely situated to observe trends in
expenditures and utilization patterns,
including by providers and suppliers
that are not participating in the ACO.
Further establishing policies to specify
the approach to excluding improper
payments from Shared Savings Program
calculations could encourage ACOs to
report to CMS and the Department of
Health and Human Services Office of
Inspector General (HHS–OIG) potential
fraud and abuse within the Medicare
program. Addressing improper
payments in the Medicare program
would protect the accuracy, fairness,
and integrity of Shared Savings Program
financial calculations, and lead to
greater beneficiary protections, and
protection of the Trust Funds.
Accounting for the impact of
improper payments in financial
calculations promotes continued
integrity and fairness of Shared Savings
Program payment determinations and
may in turn bolster ACO participation
in the Shared Savings Program. Policies
that improve the accuracy of the
payment calculations could provide
greater certainty to organizations
considering entering or continuing their
participation in the Shared Savings
Program and thereby lead to more
robust and sustained participation by
ACOs in the Shared Savings Program.
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This, in turn, means that these
organizations would continue working
towards meeting the Shared Savings
Program’s goals of lowering growth in
Medicare FFS expenditures and
improving the quality of care furnished
to Medicare beneficiaries.
As described in the Regulatory Impact
Analysis (section VII. of this proposed
rule), we believe accounting for the
impact of improper payments on
performance year expenditures and
factors used to calculate updated
historical benchmarks would not result
in an increase in spending beyond the
expenditures that would otherwise
occur under the statutory payment
methodology in section 1899(d) of the
Act. As we also discuss elsewhere in
this section of this proposed rule, across
an ACO’s reconciliations where
improper payments impact performance
year or BY expenditures, the overall net
impact of using the proposed
methodology on the ACO’s aggregate
shared savings or shared losses across
those reconciliations could be positive
or negative and would depend on the
circumstances of a given reopening
scenario.
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.
(d) Adjusting Historical Benchmarks To
Account for the Impact of Improper
Payments
CMS adjusts an ACO’s historical
benchmark annually, during the term of
the ACO’s agreement period, to account
for certain changes, as specified in the
Shared Savings Program regulations.
The related adjustment is specified
under § 425.601(a)(9), for the
benchmarking methodology applicable
to agreement periods beginning on or
after July 1, 2019, and before January 1,
2024, and under § 425.652(a)(9), for the
benchmarking methodology applicable
to agreement periods beginning on
January 1, 2024, and in subsequent
years. As finalized with the CY 2024
PFS final rule (88 FR 79195 through
79200), § 425.652(a)(9) introductory text
was amended to specify, among other
changes, that for each performance year
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during the term of the agreement period,
the ACO’s benchmark is adjusted for
changes in values used in benchmark
calculations as a result of issuance of a
revised initial determination under
§ 425.315 (among other factors). Similar
language is not currently included in
§ 425.601(a)(9) introductory text.
We propose to use our authority
under section 1899(d)(1)(B)(ii) of the
Act to adjust the benchmark to account
for the impact of improper payments, in
the event CMS recalculates a payment
determination and issues a revised
initial determination for a performance
year in a prior agreement period that
corresponds to a benchmark year of the
ACO’s current agreement period. We
propose to adjust an ACO’s historical
benchmark for use in reaching an initial
determination of financial performance
for a performance year, in cases where
an ACO has a benchmark year that
corresponds to a performance year for
which we issued a revised initial
determination. In such a case, we would
apply the same methodology to
recalculate the ACO’s BY expenditures
as used in recalculating the
expenditures for the corresponding
performance year, as part of a
reopening. Under this proposed
approach, we would be able to improve
the accuracy of the benchmark year
calculations used in reaching an initial
determination for a performance year,
by addressing the impact of previously
identified improper payments on the
expenditure calculations. Such an
adjustment to the benchmark
expenditures would appropriately
calculate the ACO’s historical
benchmark that might otherwise be
under- or over-stated due to improper
payments.
Expanding upon the example
illustrated in Table 43, if we have issued
a revised initial determination for PY
2022 in December 2025, for an ACO that
renewed to continue its participation
under a new agreement period
beginning on January 1, 2025, our
proposed policy would enable us to use
the same methodology for calculating
BY 2022 expenditures for PY 2025, in
reaching the initial determination for PY
2025.
We propose to amend §§ 425.601(a)(9)
and 425.652(a)(9) to specify this
proposed adjustment to the historical
benchmark. We propose to revise
§ 425.601(a)(9) introductory text to
further specify that for the second and
each subsequent performance year
during the term of the agreement period,
the ACO’s benchmark would be
adjusted for changes in values used in
benchmark calculations as a result of
issuance of a revised initial
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61907
determination under § 425.315. We also
propose to add a new paragraph
(a)(9)(iii) to § 425.601 and to add a new
paragraph (a)(9)(viii) to § 425.652, each
specifying that we would recalculate
benchmark year expenditures to account
for the impact of improper payments,
for the benchmark year corresponding to
a performance year for which CMS
issued a revised initial determination
under § 425.315. In recalculating
expenditures for the benchmark year,
CMS would apply the same calculation
methodology applied in recalculating
expenditures for the corresponding
performance year, in accordance with
the proposed new section of the
regulation at § 425.674.
(e) ACO Reopening Requests
The following discussion of
requesting and conducting a reopening
pertains to reopening a payment
determination for good cause or for
fraud or similar fault, unless specified
otherwise.
We propose to establish a process at
§ 425.315(b) by which an ACO may
request a reopening of an initial
determination, or a final agency
determination under subpart I, of shared
savings or shared losses. Although an
ACO’s submission of a reopening
request is optional, we propose to
require that the ACO’s request be in a
form and manner specified by CMS.
Further, we propose that the timing of
the ACO’s reopening request must be
consistent with the timeframes specified
in § 425.315(a)(1)(i) and (ii),
respectively, either (i) at any time in the
case of fraud or similar fault, or (ii) 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. We anticipate providing
additional information on the reopening
request process for ACOs through
guidance, including the form and
manner in which CMS must receive a
reopening request.
CMS will need to receive sufficient,
detailed information from ACOs to
evaluate an ACO’s reopening request.
For instance, in the case of a reopening
request in connection with improper
payments, or fraud or similar fault
potentially impacting the ACO’s
financial calculations, receiving detailed
information about the issue, including
the following information, would aid in
our analysis of the ACO’s request:
• ACO identifier(s) (also referred to as
‘‘ACO ID’’) and Legal Business Name(s).
• Identity of the provider or supplier
for which there may be improper
payment(s), or that may be suspected of
fraud or similar fault, including name,
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NPI or Provider Transaction Access
Number (PTAN), TIN, or other
identifier.
• Time period during which
potentially impacted claims were
submitted or improper conduct
occurred.
• Short description of the improper
payment, alleged fraud or similar fault,
and how it was identified, including
information such as any specific claim
type codes and HCPCS or CPT codes.
• Evidence of financial impact on the
ACO’s shared savings or shared losses
calculation, such as any analysis
supporting the calculation of financial
impact to the ACO and a list of
beneficiaries assigned to the ACO for
whom claims were submitted by the
provider or supplier suspected of fraud
or similar fault, or for which
expenditures may be impacted by
improper payments.
As we describe elsewhere in this
section of this proposed rule, a
recalculation of shared savings and
shared losses to account for improper
payments could result in a variety of
outcomes. An ACO should weigh these
potential outcomes when considering
whether to submit a reopening request.
We acknowledge that the proposed
process for requesting a reopening,
whether for good cause or for fraud or
similar fault, would represent a new
process. Therefore, we seek comments
and suggestions on the form and manner
in which CMS should receive these
requests. We also seek comment on
approaches to ensuring that ACOs
submit reopening requests with
sufficient information to allow CMS to
identify and evaluate the impact on
Shared Savings Program financial
performance.
The following steps illustrate how we
may conduct review of an ACO’s
request to reopen a payment
determination to account for the impact
of improper payments:
• Upon receiving an ACO’s reopening
request, CMS would evaluate this
request, and ask the requesting ACO to
provide supplemental information if
needed.
• We would work with CPI and law
enforcement agencies to identify,
validate and quantify improper
payments potentially impacting
expenditures used in program
calculations. We note that identification
of improper payments may be
contingent on the conclusion of an
investigation that is underway.
• We may conduct initial analysis to
consider the basis for reopening the
ACO’s payment determination under
§ 425.315(a), and the significance of the
improper payments to an ACO’s
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financial calculations under the Shared
Savings Program (as described in
section III.G.7.c.(2).(b) of this proposed
rule):
++ If we find that the potential
improper payment does not meet CMS’
standards for reopening the payment
determination, we anticipate notifying
the ACO of our decision.
++ If we reach a determination to
reopen the ACO’s payment
determination for a performance year:
—We would recalculate expenditures
to account for improper payments using
the methodology proposed in section
III.G.7.c.(2).(c) of this proposed rule,
recalculate the ACO’s shared savings
and shared losses, issue a revised initial
determination, and engage in payment
activities and recoupment activities, as
needed.
—During the recalculation period
CMS would also identify whether the
relevant performance year is also
serving as a benchmark year for the
ACO’s current agreement period and
prepare to adjust the ACO’s benchmark
year expenditures to account for the
revised initial determination (once
issued), as discussed in section
III.G.7.c.(2).(d) of this proposed rule.
In the event that improper payments
identified in analyzing an ACO’s
reopening request have the potential to
impact the payment determinations of
one or more other ACOs, we anticipate
only determining whether to reopen the
payment determination for an ACO that
submitted the reopening request. More
generally, we may initiate analysis of
the impact of improper payments on
Shared Savings Program financial
calculations, and potentially reopen the
payment determination for one or more
ACOs absent an ACO’s request for
reopening. For instance, in learning of
improper payments that may potentially
impact Shared Savings Program
calculations for multiple ACOs,
including through the reopening request
process, we may seek to reopen
payment determinations where
improper payments are anticipated to
result in significant adjustments to
ACOs’ initial determinations upon
recalculation. We also anticipate
initiating analysis of the impact of
improper payments on an ACO’s
payment determination upon learning of
improper payments originating inside
the ACO that may potentially impact
Shared Savings Program calculations,
and may reopen the ACO’s payment
determination, as needed, to address
program integrity concerns.
We anticipate that our review and
analysis of reopening requests could
occur over a protracted period of time
during which we may be able to provide
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little additional information to the ACO
until we have reached our decision. We
would aim to conduct a reopening such
that the timing of any issuance of a
revised initial determination aligns with
the timeframe for when CMS typically
completes annual performance year
financial reconciliation and payment
and recoupment. However, because
investigations into improper payments,
including considering whether there is
reliable evidence of fraud or similar
fault, may involve varying degrees of
complexity and scale, and because the
application of our proposed
methodology for calculating
expenditures relies on information that
may result from such investigations,
among other sources of information,
CMS may not always be able to conduct
a reopening within a specific timeframe
after an ACO submits a reopening
request. As reflected in the discussions
within this section of this proposed
rule, the process for analyzing an ACO’s
reopening request, reaching a decision
on whether to reopen the initial
determination, recalculating the ACO’s
payment determination, and issuing a
revised initial determination, may occur
over a period of months or potentially
years, and may have impacts on future
agreement periods. In cases where CMS
and law enforcement officials may have
investigations underway, CMS must
refrain from providing details to ACOs,
and other individuals or entities, of
pending actions to protect the integrity
of those investigations. Therefore, we
may be limited in the information we
can communicate to an ACO about our
consideration of the ACO’s reopening
request.
We seek comment on the
aforementioned considerations for how
we could conduct review of an ACO’s
request to reopen a payment
determination to account for the impact
of improper payments. More generally,
as we gain additional experience with
ACOs’ submission of reopening
requests, including the volume of the
requests, and nature of the requests, we
may revisit the reopening request
process, as needed, in future notice and
comment rulemaking.
(f) Preventing and Reporting Medicare
Fraud
ACOs can help prevent fraud and
abuse within the Medicare program or
in other Federal health care programs.
Program integrity requirements for the
Shared Savings Program include the
requirement under § 425.300 that the
ACO must have a compliance plan.
Among other required elements, an
ACO’s compliance plan must include a
method for employees or contractors of
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the ACO, ACO participants, ACO
providers/suppliers, and other
individuals or entities performing
functions or services related to ACO
activities to anonymously report
suspected problems related to the ACO
to the compliance officer
(§ 425.300(a)(3)). ACOs’ compliance
plans must also include a requirement
for the ACO to report probable
violations of law to an appropriate law
enforcement agency (§ 425.300(a)(5)).
(Refer to the November 2011 final rule,
76 FR 67951 and 67952.)
ACOs are encouraged to report
potential fraud or abuse by submitting a
complaint to the CMS Center for
Program Integrity (CPI), Fraud
Investigations Group (FIG), Division of
Provider Investigations (DPI) at
dpi.intake@cms.hhs.gov. ACOs can also
report potential fraud or abuse by
submitting a complaint to the HHS–OIG
website, https://oig.hhs.gov/fraud/
report-fraud/, HHS–OIG hotline at 1–
800–HHS–TIPS (1–800–447–8477), TTY
at 1–800–377–4950, by fax at 1–800–
223–8164, or by mailing to: Office of
Inspector General ATTN: OIG HOTLINE
OPERATIONS P.O. Box 23489
Washington, DC 20026. ACOs
suspecting healthcare fraud, waste, or
abuse are encouraged to visit the CMS
Center for Program Integrity’s web page
on Reporting Fraud, at https://
www.cms.gov/medicare/medicaidcoordination/center-program-integrity/
reporting-fraud for more information.
More generally, anyone suspecting
healthcare fraud, waste or abuse is
encouraged to report it to CMS or HHS–
OIG.
In the absence of a reopening request
submitted by an ACO in the form and
manner specified by CMS, as discussed
in section III.G.7.c.(2).(e) of this
proposed rule, the reporting of potential
fraud or abuse to CPI or HHS–OIG does
not itself constitute a reopening request
under the Shared Savings Program.
We seek comment on the proposals,
and considerations, described in this
section of this proposed rule, including:
considerations for reopening a payment
determination to account for improper
payments; the proposed changes to the
regulations to specify (1) CMS’
discretion to reopen payment
determinations, (2) a calculation
methodology to account for the impact
of improper payments in recalculating
expenditures and payment amounts
used in Shared Savings Program
financial calculations upon reopening a
payment determination pursuant to
§ 425.315, (3) an adjustment to the
historical benchmark to account for the
impact of improper payments, and (4) a
process for ACOs to request reopening
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of a payment determination. We also
welcome comments on considerations
in connection with ACOs’ potential role
in preventing and reporting Medicare
fraud.
d. Mitigating the Impact of Significant,
Anomalous, and Highly Suspect Billing
Activity on Shared Savings Program
Financial Calculations in Calendar Year
2024 or Subsequent Calendar Years
(1) Background
(a) Statutory Background on Shared
Savings Program Financial Calculations
Section 1899 of the Social Security
Act (the Act) (42 U.S.C. 1395jjj), as
added by section 3022 of the Patient
Protection and Affordable Care Act
(Pub. L. 111–148, enacted March 23,
2010), establishes the general
requirements for payments to
participating ACOs in the Shared
Savings Program. Specifically, section
1899(d)(1)(A) of the Act provides that
providers of services and suppliers
participating in an ACO will continue to
receive payment under the original
Medicare fee-for-service program under
Medicare Parts A and B in the same
manner as they would otherwise be
made. However, section 1899(d)(1)(A) of
the Act also provides for an ACO to
receive payment for shared savings
provided that the ACO meets both the
quality performance standards
established by the Secretary and
demonstrates that it has achieved
savings against a benchmark of expected
average per capita Medicare FFS
expenditures. Additionally, section
1899(i) of the Act authorizes the
Secretary to use other payment models
in place of the one-sided model
described in section 1899(d) of the Act.
This provision authorizes the Secretary
to select a partial capitation model or
any other payment model that the
Secretary determines will improve the
quality and efficiency of items and
services furnished to Medicare
beneficiaries without additional
program expenditures. We have used
our authority under section 1899(i)(3) of
the Act to establish the Shared Savings
Program’s two-sided payment model
(see for example, 80 FR 32771 and
32772, and 83 FR 67834 through 67841)
and to mitigate shared losses owed by
ACOs affected by extreme and
uncontrollable circumstances during PY
2017 and subsequent performance years
(82 FR 60916 and 60917, 83 FR 59974
through 59977), among other uses of
this authority described elsewhere in
this proposed rule.
Section 1899(d)(1)(B)(i) of the Act
specifies that, in each year of the
agreement period, an ACO is eligible to
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61909
receive payment for shared savings only
if the estimated average per capita
Medicare expenditures under the ACO
for Medicare FFS beneficiaries for Parts
A and B services, adjusted for
beneficiary characteristics, is at least the
percent specified by the Secretary below
the applicable benchmark under section
1899(d)(1)(B)(ii) of the Act. Section
1899(d)(1)(B)(ii) of the Act addresses
how ACO benchmarks are to be
established and updated under the
Shared Savings Program. This provision
specifies that the Secretary shall
estimate a benchmark for each
agreement period for each ACO using
the most recent available 3 years of per
beneficiary expenditures for Parts A and
B services for Medicare FFS
beneficiaries assigned to the ACO. This
benchmark shall be adjusted for
beneficiary characteristics and such
other factors as the Secretary determines
appropriate and updated by the
projected absolute amount of growth in
national per capita expenditures for
Parts A and B services under the
original Medicare FFS program, as
estimated by the Secretary.
In past rulemaking, we have used our
authority under sections
1899(d)(1)(B)(ii) and 1899(i)(3) of the
Act to establish adjustments to the
benchmark and program expenditure
calculations, respectively, to exclude
certain Medicare Parts A and B
payments. In the November 2011 final
rule (76 FR 67920 through 67922), we
adopted an alternate payment
methodology that excluded Indirect
Medical Education (IME) and
Disproportionate Share Hospital (DSH)
payments from ACO benchmark and
performance year expenditures due to
concerns that the inclusion of these
amounts would incentivize ACOs to
avoid referring patients to the types of
providers that receive these payments.
In the CY 2023 PFS final rule (87 FR
69954 through 69956), we excluded new
supplemental payments to Indian
Health Service/Tribal hospitals and
hospitals located in Puerto Rico
consistent with our longstanding policy
to exclude IME, DSH and
uncompensated care payments from
ACOs’ assigned and assignable
beneficiary expenditure calculations. In
the May 8, 2020 COVID–19 IFC (85 FR
27577 through 27582), we established a
methodology to adjust Shared Savings
Program financial calculations to
account for the COVID–19 Public Health
Emergency. Specifically, we established
a methodology that would exclude all
Medicare Parts A and B FFS payment
amounts for a beneficiary’s episode of
care for treatment of COVID–19 to
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prevent distortion to, among other
calculations, an ACO’s benchmark and
program expenditure calculations.
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(b) Background on Significant,
Anomalous, and Highly Suspect Billing
Activity
Recently, ACOs and other interested
parties have raised concerns about an
increase in billing to Medicare for
selected intermittent urinary catheter
supplies on Durable Medical
Equipment, Prosthetics, Orthotics &
Supplies (DMEPOS) claims in CY 2023,
alleging that the increase in payments
represents fraudulent activity (the
‘‘alleged conduct’’). The observed
DMEPOS billing volume for intermittent
urinary catheters in CY 2023 represents
significant, anomalous, and highly
suspect (SAHS) billing activity.525
Generally, a level of billing for a given
HCPCS or CPT code is considered SAHS
billing activity when a given HCPCS or
CPT code exhibits a level of billing that
represents a significant claims increase
either in the volume or dollars (for
example, dollar volume significantly
above prior year, or claims volume
beyond expectations) with national or
regional impact (for example, not only
impacting one or few ACOs) and
represents a deviation from historical
utilization trends that is unexpected and
is not clearly attributable to reasonably
explained changes in policy or the
supply or demand for covered items or
services. The billing level is significant
and represents billing activity that
would cause significantly inaccurate
and inequitable payments and
repayment obligations in the Shared
Savings Program if not addressed.
Current Shared Savings Program
regulations, codified at 42 CFR part 425,
do not provide a basis for CMS to adjust
program expenditure or revenue
calculations to remove the impact of
SAHS billing activity such as that
arising from the alleged conduct in
advance of issuing an initial
determination. As discussed in section
III.G.7.c of this proposed rule, CMS may
reopen an initial determination or a
final agency determination and issue a
revised initial determination at any time
in the case of fraud or similar fault, and
525 SAHS billing activity may appear in claims for
items and services rendered to beneficiaries
assigned to an ACO as well as for beneficiaries who
are not assigned to an ACO. Such activity may be
caused by providers and suppliers who participate
in an ACO and who do not participate in an ACO.
This discussion is primarily focused on SAHS
billing activity performed by providers and
suppliers that do not participate in ACOs billing
items and services for beneficiaries who are
assigned to ACOs or who are in the assignable
population used in national and regional factors
used in Shared Savings Program calculations.
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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 (§ 425.315). This does not allow
for CMS to address SAHS billing
activity, which must be addressed prior
to conducting financial reconciliation,
which is an initial determination, to
prevent significant inequity and
inaccurate payment determinations.
We are concerned that such SAHS
billing activity, should it occur in CY
2024 or later, would inflate Medicare
Parts A and B payment amounts and
affect Shared Savings Program
calculations, including:
• Performance year reconciliation
calculations, including expenditures for
each ACO’s assigned beneficiaries for
the calendar year that has SAHS billing
activity, the national-regional blended
update factor used to update the
benchmark for ACOs beginning an
agreement period before January 1, 2024
(refer to § 425.601(b)), the three-way
blended update factor used to update
the benchmark for ACOs beginning an
agreement period on January 1, 2024
and in subsequent years (refer to
§ 425.652(b)), and factors based on ACO
participant revenue to determine the
loss recoupment limits for ACOs
participating under two-sided models of
the BASIC track (Levels C, D, E) (refer
to § 425.605(d)).
• Historical benchmark calculations
for establishing the benchmark for ACOs
beginning new agreement periods on
January 1, 2025, or in subsequent years
with a benchmark year that has SAHS
billing activity (refer to § 425.652(a)).
• Factors used in the application
cycle for ACOs applying to enter a new
agreement period beginning two years
after the SAHS billing activity occurred,
and the change request cycle for ACOs
continuing their participation in the
program, including data used to
determine an ACO’s eligibility for
Advance Investment Payments under
§ 425.630(b) or for the CMS Innovation
Center’s new ACO Primary Care Flex
Model (ACO PC Flex Model) based on
ACO revenue status (high revenue or
low revenue), and to determine
repayment mechanism amounts for
ACOs entering, or continuing in, twosided models (refer to § 425.204(f)).
The accuracy of the Shared Savings
Program’s determination of an ACO’s
financial performance (through a
process referred to as financial
reconciliation) in terms of the ACO’s
eligibility for and amount of a shared
savings payment or liability for shared
losses, depends on the accuracy of
claims data. Absent CMS action, SAHS
billing activity would affect
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performance year financial
reconciliation program-wide rather than
being limited to ACOs that have
assigned beneficiaries directly impacted
by the issue. For instance:
• An ACO with assigned beneficiaries
impacted by the SAHS billing activity
will see an increase in performance year
expenditures, reducing the ACO’s
shared savings or increasing the amount
of shared losses owed by the ACO. The
impact on the ACO’s performance may
be partially mitigated if the SAHS
billing activity also increases the ACO’s
regional service area expenditures and
the national expenditures used to
calculate the two-way national-regional
blended benchmark update factor.
• An ACO with assigned beneficiary
expenditures and regional service area
expenditures with little or no impact
from the SAHS billing activity will
receive a relatively higher benchmark
update under the national-regional
blended update factors used in
performance year reconciliation, and
therefore, may appear to perform better
as a result of the national impact of the
SAHS billing activity, resulting in
higher earned performance payments or
lower or no losses for the ACO.
Unaddressed, SAHS billing activity in
a given calendar year can distort the
historical benchmarks for an ACO in an
agreement period that have the calendar
year as a benchmark year and the
accuracy of any future financial
reconciliation performed against those
benchmarks. Similarly, inaccurate
revenue and expenditure calculations
based on data from a calendar year
affected by SAHS billing activity may
affect an ACO’s revenue status and the
amount of funds an ACO in a two-sided
model must secure as a repayment
mechanism, one of the program’s
important safeguards for protecting the
Medicare Trust Funds. Absent CMS
action, SAHS billing activity likely
would significantly impact shared
savings and losses calculations for the
performance year affected by SAHS
billing activity, and for future
performance years that have benchmark
years affected by SAHS billing activity.
Under these circumstances, some ACOs
would likely experience adverse
impacts (for example, lower or no
shared savings or higher shared losses)
while other ACOs would experience
windfall gains (for example, higher
shared savings or lower or no shared
losses).
Failing to address SAHS billing
activity would jeopardize the integrity
of the Shared Savings Program. There
are 480 ACOs in the Shared Savings
Program with over 608,000 health care
providers who care for 10.8 million
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assigned FFS beneficiaries.526 In PY
2022, the most recent year for which
data is available, savings achieved by
ACOs relative to benchmarks amounted
to $4.3 billion, of which ACOs received
shared savings payments totaling $2.5
billion, and Medicare retained $1.8
billion in savings.527 ACOs are held
accountable for 100 percent of total
Medicare Parts A and B expenditures for
their assigned beneficiary populations
(with limited exceptions). This
incentivizes ACOs to generate savings
for the Medicare program as they have
the opportunity to share in those
savings if certain requirements are met.
It also discourages the ACO from
generating unnecessary expenditures for
Medicare as they may be required to
repay those amounts to CMS.
Accountable care arrangements such as
this cannot function if the ACO may be
held responsible for all SAHS billing
activity that is outside of their control.
Holding an ACO accountable for
substantial losses due to SAHS billing
activity is not only inequitable but will
dramatically increase the level of risk
associated with participation, making
the Shared Savings Program
unattractive.
In a separate proposed rule entitled
‘‘Medicare Program: Mitigating the
Impact of Significant, Anomalous, and
Highly Suspect Billing Activity on
Medicare Shared Savings Program
Financial Calculations in Calendar Year
2023’’ (89 FR 55168, July 3, 2024)
(referred to herein as the SAHS billing
activity proposed rule), we have
proposed an approach to address the
SAHS billing activity identified for CY
2023 to protect the accuracy, fairness,
and integrity of Shared Savings Program
financial calculations. Specifically, we
have proposed to exclude payment
amounts for two HCPCS codes (A4352
(Intermittent urinary catheter; Coude
(curved) tip, with or without coating
(Teflon, silicone, silicone elastomeric, or
hydrophilic, etc.), each) and A4353
(Intermittent urinary catheter, with
insertion supplies)) on DMEPOS claims
submitted by any supplier from
expenditure and revenue calculations
used for: assessing performance year
(PY) 2023 financial performance of
Shared Savings Program ACOs,
establishing benchmarks for ACOs
starting agreement periods in 2024,
526 Refer to CMS, Shared Savings Program Fast
Facts—As of January 1, 2024, available at https://
www.cms.gov/files/document/2024-shared-savingsprogram-fast-facts.pdf.
527 Refer to CMS, Shared Savings Program
Performance Year Financial and Quality Results,
2022, available at https://data.cms.gov/medicareshared-savings-program/performance-yearfinancial-and-quality-results/data.
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2025, and 2026, and calculating factors
used to determine revenue status and
repayment mechanism amounts in the
application and change request cycle for
ACOs applying to enter a new
agreement period beginning on January
1, 2025, or continue their participation
in the program in PY 2025, respectively.
There will be a 30-day public comment
period on the SAHS billing activity
proposed rule so as to minimize the
negative impact on ACOs of a delay in
the issuance of PY 2023 initial financial
determinations and disbursement of
performance payments, as well as to
other program milestones, necessitated
by the calculation of amounts under the
financial methodology proposed in the
SAHS billing activity proposed rule.
(2) Proposed Revisions
It is important to establish a policy
that would allow CMS to proactively
make similar adjustments for future
calendar years, should new SAHS
billing activity be identified. In general,
we anticipate that billing activity that
meets the high bar to be considered
significant, anomalous, and highly
suspect billing activity will be a rare
occurrence. This is evidenced by the
program’s history. The SAHS billing
activity surrounding selected catheter
codes in 2023 is the first occasion we
have had in the program’s 12-year
history to consider this issue. We
propose that we would notify ACOs and
ACO applicants of our determinations to
remove any codes and the aggregate per
capita dollar amount of the codes
removed as part of the annual financial
reconciliation process. While we
anticipate future occurrences of the
scope and magnitude observed for
urinary catheters in CY 2023 to be rare,
having a permanent policy in place
would:
• Allow CMS to move quickly to
make adjustments to financial
calculations without having to engage in
additional rulemaking, ensuring timely
issuance of initial determinations of
savings and losses and disbursement of
earned performance payments;
• Provide ACOs with greater certainty
that they will not be held accountable
for SAHS billing activity that is out of
their control, promote integrity and
fairness and ensure accuracy of program
calculations;
• Limit requests to reopen initial
determinations, thus reducing burden
for ACOs and CMS.
In this proposed rule we are therefore
proposing an approach by which we
would adjust Shared Savings Program
calculations to mitigate the impacts of
SAHS billing activity occurring in CY
2024 or subsequent calendar years.
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(a) Identifying Significant, Anomalous,
and Highly Suspect Billing Activity
We propose that CMS would have the
sole discretion to identify cases of SAHS
billing activity for a particular calendar
year that would warrant the adjustment
of Shared Savings Program financial
calculations. We anticipate routinely
examining billing trends identified by
CMS and other relevant information that
had been raised through complaints by
ACOs or other interested parties to the
HHS–OIG or to the CMS CPI. We would
seek to identify and monitor any codes
that would potentially trigger the
adjustment policy by meeting the high
bar for removal under the criteria used
to determine SAHS billing activity.
Shortly after the start of a calendar year
CMS would make a final determination
as to which codes, if any, warrant
adjustments for the previous calendar
year. For example, in early CY 2026
CMS would make a final determination
of whether any codes met the high bar
for removal under the criteria used to
determine SAHS billing activity in CY
2025, allowing time for the adjustments
to be incorporated in forthcoming
calculations.
CMS must retain sole discretion to
identify cases of SAHS billing activity
because we cannot anticipate what
SAHS billing activity we may encounter
in the future that may warrant
adjustments to the program’s financial
calculations. We are also concerned
about balancing adjustments for billing
activity that rises to the level of SAHS
versus removing payment amounts
associated with billing activity due to
inefficiencies that are within the ACO’s
control. Depending on the frequency of
the use of this authority and the
occurrence of SAHS billing activity, and
thus the experience we develop in this
area, we would consider proposing to
codify criteria to identify SAHS billing
activity in the future through additional
rulemaking. Nonetheless, we believe
that CMS should retain sole discretion
to determine whether SAHS billing
activity occurred on a case-by-case basis
at this time.
We anticipate considering multiple
criteria in determining whether SAHS
billing activity warrants removal of the
corresponding billing codes from
Shared Savings Program financial
calculations. These criteria include:
• The observed increase in claims for
a HCPCS or CPT code year-to-year meets
the definition of significant, anomalous,
and highly suspect billing activity, as
defined elsewhere in this section of this
proposed rule;
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• The observed billing activity has
national or regional impact or
significance, such as:
++ Involves a Medicare provider or
supplier, a beneficiary population and/
or states with claims activity that that
significantly impacts national or
regional expenditure values or trends;
++ Warrants adjustment (all or
partial) to national Medicare
expenditure trend calculations used in
payment (for example, United States Per
Capita Cost) and/or Federal budget
forecast calculations;
++ Warrants removal from national
and regional growth rates used to
update ACO historical benchmarks;
• If no action is taken there would be
an imbalance between ACO
performance year and historical
benchmark year expenditures;
• Use of payment amounts associated
with the SAHS billing activity could
result in payment inaccuracies that
produce significantly inaccurate and
inequitable payment determinations in
the Shared Savings Program (including
the amount of shared savings or shared
losses), due to factors beyond the
control of ACOs; and
• The claims in question may be
disproportionately represented by
Medicare providers or suppliers whose
Medicare enrollment status has been
revoked.
We anticipate utilizing this authority
only in rare and extreme cases where a
number of the criteria are satisfied. We
anticipate we would consider the extent
to which the billing activity meets each
criterion when developing a holistic
assessment of the billing activity’s
impact on the Shared Savings Program.
The extent of the geographic impact of
the SAHS billing activity in question is
relevant given that the proposed policy
would entail adjustments program-wide.
One consideration for determining
whether the billing activity has national
or regional significance would be if the
pattern warrants an adjustment to or
special assumption for calculating
official Medicare expenditure trends
(such as the United States Per Capita
Cost (USPCC) or Federal budget
forecasts) due to the activity’s
significant, anomalous, and highly
suspect nature. For example, the 2024
Medicare Trustees Report noted a
significant increase in suspected
fraudulent spending on certain
intermittent catheters in 2023.528 The
528 The Boards of Trustees, Federal Hospital
Insurance and Federal Supplementary Medical
Insurance Trust Funds, ‘‘2024 Annual Report of the
Boards of Trustees of the Federal Hospital
Insurance and Federal Supplementary Medical
Insurance Trust Funds’’, p. 136, available at https://
www.cms.gov/oact/tr/2024.
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DME projections in the report include
the assumption that this suspected fraud
will be addressed during 2024.529
Billing activity in the Medicare FFS
program at a scale warranting a special
assumption for calculating the USPCC
or Federal budget forecasts has per se
national or regional significance, and
thus would likely rise to the high bar of
warranting adjustment to Shared
Savings Program expenditure and
revenue calculations.
We would seek to assess whether the
billing activity creates an imbalance
between ACO performance year and
historical benchmark year expenditures.
This assessment could involve
considering whether the increase in
billing activity was at such scale that it
causes the difference between
performance year and benchmark year
expenditures for an ACO’s assigned
beneficiary population for the claim
type affected by the billing activity (for
example, DMEPOS) to be substantially
larger than differences for other claim
types.
We would also consider whether the
billing activity, and any inaccurate or
inequitable payment determinations
that could result from using the related
payment amounts, was outside of
Shared Savings Program ACOs’ ability
to reasonably control. Most commonly,
this would entail examining whether
the Medicare providers or suppliers
billing the codes in question are ACO
providers or suppliers. Generally, we
would be more likely to apply the
proposed policy if the SAHS billing
activity were outside of the ACO’s
control as the program may otherwise
lack a means to control the growth of
such amounts.
Finally, we would consider whether
billing activity were disproportionately
represented by Medicare providers or
suppliers whose Medicare enrollment
status has been revoked. Such a
circumstance would provide further
evidence that the billing activity
surrounding these codes was highly
suspect. We seek comment on the
processes and criteria described.
(b) Adjustments to Shared Savings
Program Calculations
In the event that CMS identifies one
or more HCPCS or CPT codes with
SAHS billing activity in CY 2024 or a
subsequent calendar year that warrant
adjustment, we propose to exclude all
Medicare Parts A and B payment
amounts associated with the identified
codes on specified claim types
submitted by any provider or supplier
from expenditure and revenue
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calculations for the relevant calendar
year for which the SAHS billing activity
is identified. For example, if CMS
identifies one or more codes with SAHS
billing activity in CY 2025 that warrant
adjustment, we would exclude
payments for those codes for both
calculations where CY 2025 is the
performance year and in calculations
where CY 2025 is a benchmark year for
ACOs in agreement periods beginning in
2026, 2027, and 2028.
We propose that we would also adjust
the 3 most recent years prior to the start
of the ACO’s agreement period used in
establishing the historical benchmark
that is used to reconcile the ACO for a
performance year corresponding to the
calendar year for which the SAHS
billing activity was identified. In the
example where CMS identified SAHS
billing activity for 2025, we would
adjust benchmark expenditures (ACO,
national, and regional) for 2019, 2020,
and 2021, for an ACO that began an
agreement period in 2022 (for which PY
2025 is the fourth performance year in
its agreement period) and would adjust
benchmark expenditures (ACO,
national, and regional) for 2022, 2023,
and 2024 for an ACO that began its
agreement period in 2025 (for which PY
2025 is the first performance year in its
agreement period). Note that in
computing benchmark expenditures for
2023 for this second ACO, because 2023
is a benchmark year, CMS would also
exclude payments for the catheter
claims with SAHS billing activity in
2023, as proposed in the SAHS billing
activity proposed rule, if finalized.
Our proposal to adjust an ACO’s
historical benchmark to exclude
Medicare Parts A and B FFS payment
amounts associated with the HCPCS or
CPT codes displaying SAHS billing
activity during a performance year
would achieve greater consistency
between the benchmark period and the
performance year, given that we are
excluding all payments on specified
claim types for the selected codes from
performance year calculations,
including payments that would have
been made in the absence of any SAHS
billing activity. This helps to ensure a
balance between the benchmark and the
performance year such that an ACO is
not unfairly benefitting from a
benchmark that includes certain
expenditures that are excluded from the
performance year. Under our proposal,
we would identify any codes warranting
adjustment at the start of the next
calendar year and our operational
schedule would accommodate the
additional calculations required.
Therefore, we anticipate we would be
able to compute adjusted historical
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benchmarks for the affected
reconciliation with minimal, if any,
delays to the typical timeline for issuing
initial determinations.
We propose that we would provide
the historical benchmark that has been
adjusted to exclude payment amounts
for HCPSC or CPT codes associated with
SAHS billing activity occurring in the
performance year being reconciled to
ACOs as part of their financial
reconciliation settlement package for the
performance year, as opposed to
providing a separate new historical
benchmark report in advance of
settlement. This approach is consistent
with what we have done for rare past
occasions where we computed revised
benchmarks immediately prior to
reconciliation to correct for latebreaking data issues. Consistent with
existing operational practice, in
calculating these adjusted benchmarks,
we would recompute ACO expenditures
using beneficiary assignment data that
was generated during the performance
year being reconciled for all ACOs. For
example, if computing adjusted
historical benchmarks for PY 2025 to
exclude claim payments for codes with
SAHS billing activity during the
performance year, we would use
beneficiary assignment data generated
during CY 2025. Although the
benchmark year assignment data
generated during the performance year
being reconciled would be based on the
same ACO participant list, assignment
methodology selection under
§ 425.226(a)(1), and assignment
methodology under subpart E of Part
425 of the regulations as used in
calculating the ACO’s most recent prior
benchmark, other factors, such as more
recent Medicare beneficiary eligibility
data along with the ACOs included in
the claims-based assignment
competition, could differ and impact an
ACO’s assigned population. We
considered whether to provide ACOs
with their adjusted benchmark at the
time we announce our determination of
SAHS billing activity for a given
calendar year (anticipated to occur near
the start of the next calendar year),
however we concluded this would delay
other important program milestones,
such as the issuance of preliminary and
adjusted historical benchmarks for the
new performance year.
When the calendar year with SAHS
billing activity becomes a benchmark
year, we are proposing adjustments to
calculations for the calendar year itself,
and not for other years in the
benchmark period, or the performance
years that will be reconciled against
those benchmarks. Thus, in the example
where we identified codes with SAHS
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billing activity in CY 2025, in
establishing or resetting the benchmark
for an ACO entering an agreement
period in 2026, we would exclude
payments for the relevant codes
identified for CY 2025 from BY 2025
calculations and, if our proposed policy
in the SAHS billing activity proposed
rule is finalized, would remove
payments for the specified catheter
codes from BY 2023 calculations. We
would not exclude the catheter codes
identified as having SAHS billing
activity in BY 2023 or the codes
identified for CY 2025 from either BY
2024 calculations or calculations for PY
2026 or any subsequent performance
years in the same agreement period.530
Specifically, we are proposing to
adjust the following Shared Savings
Program calculations, as applicable, to
exclude all Medicare Parts A and B
payment amounts associated with a
HCPCS or CPT code on claims for the
specified claim types displaying SAHS
billing activity:
• Calculation of Medicare Parts A and
B FFS expenditures for an ACO’s
assigned beneficiaries for all purposes
including the following: Establishing,
adjusting, updating, and resetting the
ACO’s historical benchmark and
determining performance year
expenditures.
• Calculation of FFS expenditures for
assignable beneficiaries as used in
determining county-level FFS
expenditures and national Medicare
FFS expenditures, including the
following calculations:
++ Determining average county FFS
expenditures based on expenditures for
the assignable population of
beneficiaries in each county in the
ACO’s regional service area according to
§§ 425.601(c) and 425.654(a) for
purposes of calculating the ACO’s
regional FFS expenditures.
++ Determining the 99th percentile of
national Medicare FFS expenditures for
assignable beneficiaries for purposes of
the following:
-- Truncating assigned beneficiary
expenditures used in calculating
benchmark expenditures under
§§ 425.601(a)(4) and 425.652(a)(4), and
performance year expenditures under
§§ 425.605(a)(3) and 425.610(a)(4).
-- Truncating expenditures for
assignable beneficiaries in each county
for purposes of determining county FFS
expenditures according to
§§ 425.601(c)(3) and 425.654(a)(3).
-- Truncating expenditures for
assignable beneficiaries for purposes of
530 This assumes these same codes were not
identified as having SAHS billing activity in CY
2024 or CY 2026 or later years.
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determining truncated national per
capita FFS expenditures for purposes of
calculating the Accountable Care
Prospective Trend (ACPT) according to
§ 425.660(b)(3).
++ Determining truncated national
per capita expenditures FFS per capita
expenditures for assignable beneficiaries
for purposes of calculating the ACPT
according to § 425.660(b)(3).
++ Determining national per capita
expenditures for Parts A and B services
under the original Medicare FFS
program 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 § 425.658(c)(1)(ii), capping
the prepaid shared savings multiplier
according to § 425.640(f)(2)(v), and
calculating the proposed HEBA scaler
according to § 425.662(b)(2).
++ Determining national growth rates
that are used as part of the blended
growth rates used to trend forward BY1
and BY2 expenditures to BY3 according
to §§ 425.601(a)(5)(ii) and
425.652(a)(5)(ii) and as part of the
blended growth rates used to update the
benchmark according to §§ 425.601(b)(2)
and 425.652(b)(2)(i).
• Calculation of Medicare Parts A and
B FFS revenue of ACO participants for
purposes of calculating the ACO’s loss
recoupment limit under the BASIC track
as specified in § 425.605(d).
• Calculation of total Medicare Parts
A and B FFS revenue of ACO
participants and total Medicare Parts A
and B FFS expenditures for the ACO’s
assigned beneficiaries for purposes of
identifying whether an ACO is a high
revenue ACO or low revenue ACO, as
defined under § 425.20, determining an
ACO’s eligibility to receive advance
investment payments according to
§ 425.630, and determining whether an
a ACO qualifies for a shared savings
payment under § 425.605(h).
• Calculation or recalculation of the
amount of the ACO’s repayment
mechanism arrangement according to
§ 425.204(f)(4).
This approach would recognize that
SAHS billing activity has the potential
to impact an ACO’s savings and loss
determination for both the performance
year when the SAHS billing activity
occurred and future performance years
for which the affected year is a
benchmark year. Making adjustments
when the affected period represents a
performance year or benchmark year is
consistent with our approach for the
exclusion of payment amounts for
episodes of care for treatment of
COVID–19 that we established in the
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May 8, 2020 COVID–19 IFC (85 FR
27577 through 27581).
The listed calculations reflect the
same set of calculations that CMS
adjusts for a beneficiary’s episode of
care for treatment of COVID–19,
specified at § 425.611(c), as amended by
the CY 2021 PFS final rule (85 FR
85044), the CY 2023 PFS final rule (87
FR 70241), and the CY 2024 PFS final
rule (88 FR 79548), with a few
exceptions. First, § 425.611(c) includes
certain provisions that are not relevant
for the proposed policy.531 Second, the
proposed policy includes calculations
related to truncated national per capita
expenditures used in determining the
ACPT as described in § 425.660(b)(3)
that are not included in § 425.611(c),532
as well as references to other new or
proposed calculations that do not rely
on expenditures from a period of time
overlapping the Public Health
Emergency for COVID–19 for the United
States which was in effect from January
27, 2020, through May 11, 2023
(capping the proposed prepaid shared
savings multiplier (§ 425.640(f)(2)(v)),
calculating the proposed HEBA scaler
(§ 425.662(b)(2)), and determining
whether an ACO that does not meet its
minimum savings requirement qualifies
for a shared savings payment
(§ 425.605(h)). We propose to adjust
calculations used for the ACPT to
mitigate the impact of any SAHS billing
activity identified for CY 2024 or
subsequent calendar years. Specifically,
in projecting growth rates at the start of
an agreement period according to
§ 425.660, we would make an
adjustment to the growth rates to
mitigate the impact that any known
SAHS billing activity have on spending
growth projections.
We believe it is unlikely that fixed
growth rates projected at the start of
agreement periods beginning in earlier
531 This includes provisions under §§ 425.600,
425.602, 425.603, 425.604, and 425.606 which are
not relevant for the proposed policy because they
are not applicable to PY 2024 or later performance
years or for agreement periods where CY 2024 or
later years are benchmark years. These provisions
are relevant for the COVID–19 episode exclusion
policy under § 425.611 because they are applicable
to performance or benchmark years that overlap
with the COVID–19 PHE.
532 When establishing the ACPT in the CY 2023
PFS final rule, we noted that the first ACPT release
would be published in 2024 for agreement periods
beginning on January 1, 2024, and would provide
a projected annualized growth rate (or rates) relative
to the 2023 benchmark year (BY3). We noted further
that to the extent that Medicare projections made
at that time (2024) anticipated lingering effects from
the COVID–19 pandemic then they would be
reflected in the ACPT (see 87 FR 69894) and we
opted not to amend § 425.611 to include
adjustments of ACPT-related calculations. However,
it is appropriate to propose making adjustments to
ACPT-related calculations in this proposed rule.
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years may also need mitigation from a
code displaying SAHS billing activity.
For example, if CMS identifies a HCPCS
or CPT code displaying SAHS billing
activity in CY 2025, the projected
growth rate from 2023 to 2025—which
will be used to update the historical
benchmark for PY 2025 financial
reconciliation for ACOs that began an
agreement period on January 1, 2024—
would likely have assumed typical
billing patterns for the code in CY 2025.
Additionally, the projected growth rate
from BY 2024 to PY 2025—which will
be used to update the historical
benchmark for PY 2025 financial
reconciliation for ACOs that began an
agreement period on January 1, 2025—
would likely also have assumed typical
billing patterns for the code in CY 2025
given the projections were finalized
early in CY 2025.
However, if we determine a bias exists
due to differences between adjustments
to the projected growth rates for the
ACPT and other Shared Savings
Program calculations, we could rely on
our current policy under
§ 425.652(b)(4)(ii) to reduce the weight
of the ACPT in the three-way blend. We
propose that we would use our
discretion to reduce the weight of the
ACPT rather than recalculate the growth
rates that had been projected at the start
of agreement periods starting in earlier
years, as we believe it is important to
maintain the policy that the projected
growth rates remain fixed for the ACO’s
agreement period. In the CY 2023 PFS
final rule (refer to 87 FR 69886 through
69898) we finalized our proposal to
establish the ACPT at the outset of an
agreement period, based on one or more
annualized growth rates. We explained
that we will not adjust the ACPT due to
external factors such as geographic price
changes, efficiency discounts, or other
retrospective updates occurring during
the performance years throughout the
agreement period. In response to
commenters concern that CMS might
adjust the ACPT downward during the
agreement period, we stated that we will
not adjust the ACPT projections over the
course of the agreement period (87 FR
69897). However, we acknowledged that
a variety of circumstances could cause
actual expenditure trends to
significantly deviate from projections. If
unforeseen circumstances occur during
an ACO’s agreement period we retained
flexibility to reduce the impact of the
prospectively determined ACPT portion
of the three-way blend when necessary
to mitigate unforeseen circumstances.
We explained that we anticipate
determining, on an ad hoc basis,
whether an unforeseen circumstance
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warrants adjustment of the weight
placed on the ACPT component of the
three-way blend by considering whether
it has a material impact across the entire
Shared Savings Program. If we
determine that expenditure growth has
differed significantly from projections
made at the start of the agreement
period due to unforeseen circumstances,
such as an economic recession,
pandemic, or other factors, a reduction
in the weight placed on the ACPT may
be considered.
To summarize, we propose that when
projecting growth rates used for the
ACPT at the beginning of an agreement
period, we would make an adjustment
to mitigate the impact of any known
SAHS billing activity on spending
growth projections. Additionally, in
accordance with § 425.660(a), CMS
would not adjust the ACPT projections
over the course of the agreement period
to account for SAHS billing activity
later identified. Rather, CMS may use its
discretion to reduce the weight of the
ACPT in the three-way blend in
accordance with § 425.652(b)(4)(ii) if
CMS determines that the SAHS billing
activity represents an unforeseen
circumstance that warrants a reduction
to the weight.
The direction and magnitude of the
impact of the proposed adjustments may
vary by ACO. However, by making these
adjustments, we would be helping to
ensure that no ACOs are held
accountable, and financially penalized
for SAHS billing activity that was
outside their direct control while also
protecting the Trust Funds from other
ACOs potentially receiving windfall
gains.
For this proposal, we rely on our
authority under section 1899(d)(1)(B)(ii)
of the Act. Section 1899(d)(1)(B)(ii) of
the Act authorizes the Secretary to
adjust the benchmark for beneficiary
characteristics and such other factors as
the Secretary determines appropriate.
Here, we are proposing to adjust the
benchmark in order to remove payments
for HCPCS or CPT codes identified as
exhibiting SAHS billing activity in CY
2024 or subsequent calendar years from
the determination of benchmark
expenditures when the calendar year
serves as a benchmark year or from the
determination of benchmark
expenditures that will be used to
reconcile the calendar year when it
serves as a performance year.
We propose to use our authority
under section 1899(i)(3) of the Act to
remove payment amounts for HCPCS or
CPT codes identified as exhibiting
SAHS billing activity in CY 2024 or
subsequent calendar years from the
following calculations: (1) performance
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year expenditures; (2) updates to the
historical benchmark; and (3) ACO
participants’ Medicare FFS revenue
used for multiple purposes across the
Shared Savings Program, including
determinations of loss sharing limits in
the two-sided models of the BASIC
track,533 determinations of eligibility for
advance investment payments,534 and
expanded criteria for certain low
revenue ACOs participating in the
BASIC track to qualify for shared
savings in the event the ACO does not
meet the minimum savings rate.535
Section 1899(i)(3) of the Act requires
that we determine that the alternative
payment methodology adopted under
that provision would improve the
quality and efficiency of items and
services furnished to Medicare
beneficiaries, without resulting in
additional program expenditures. The
adjustments we are proposing herein,
which would remove payment amounts
for codes with identified SAHS billing
activity from the specified Shared
Savings Program calculations as
proposed in § 425.672(c) and (e), would
capture and remove from program
calculations expenditures that are
outside of an ACO’s control, but that
could significantly affect the ACO’s
performance under the program. In
particular, failing to remove these
payments would likely create highly
variable savings and loss results for
individual ACOs that happen to have
over-representation or underrepresentation of SAHS billing activity
for the selected codes among their
assigned beneficiary populations.
As described in the Regulatory Impact
Analysis (section VII. of this proposed
rule), excluding payment amounts for
the selected codes from the specified
calculations are not expected to result in
an increase in spending beyond the
expenditures that would otherwise
occur under the statutory payment
methodology in section 1899(d) of the
Act. Further, these adjustments to our
calculations to remove payment
amounts for these codes would promote
continued integrity and fairness and
improve the accuracy of Shared Savings
Program financial calculations. As a
result, we expect these policies would
support ACOs continued participation
in the Shared Savings Program and the
program’s goals of lowering growth in
Medicare FFS expenditures and
improving the quality of care furnished
to Medicare beneficiaries.
533 Refer to § 425.605(d)(1)(iii)(D), (d)(1)(iv)(D),
and (d)(1)(v)(D) for BASIC track Levels C, D and E,
respectively.
534 Refer to § 425.630(b).
535 Refer to § 425.605(h).
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Based on these considerations, and as
specified in the Regulatory Impact
Analysis (section VII. of this proposed
rule), we have determined that adjusting
certain Shared Savings Program
calculations to remove payment
amounts for selected codes, in the event
we determine SAHS billing activity
occurs in CY 2024 or subsequent
calendar years, from the calculation of
performance year expenditures, updates
to the historical benchmark, and ACO
participants’ Medicare FFS revenue
used for multiple purposes across the
Shared Savings Program, meets the
requirements for use of our authority
under section 1899(i)(3) of the Act when
incorporated into the existing other
payment model we have established
pursuant to that section.
The changes that we are proposing in
this section of this proposed rule would
apply to address the impact of SAHS
billing activity identified in CY 2024 or
subsequent calendar years, and thus
would apply to ACOs currently
participating in PY 2024. Therefore, if
finalized, these changes to policies
applicable for PY 2024 would constitute
retroactive rulemaking. Section
1871(e)(1)(A)(ii) of the Act permits a
substantive change in regulations,
manual instructions, interpretive rules,
statements of policy, or guidelines of
general applicability under Title XVIII
of the Act to be applied retroactively to
items and services furnished before the
effective date of the change if the failure
to apply the change retroactively would
be contrary to the public interest.
Failing to apply the proposed changes
retroactively to PY 2024 would be
contrary to the public interest because it
would unfairly punish Shared Savings
Program ACOs by forcing them to
unexpectedly assume a substantial
magnitude of financial risk for costs
outside of their control and not
previously contemplated in the Shared
Savings Program, undermining both the
sustainability of the Shared Savings
Program and the public’s faith in CMS
as a fair partner, in the event we
determine SAHS billing activity impacts
CY 2024. We did not fully contemplate
the potential for SAHS billing activity
outside of an ACO’s control when the
Shared Savings Program was
established.536 For this reason, the
Shared Savings Program financial
methodology and the procedures we
have utilized in the past did not provide
a means to adequately account for
instances of SAHS billing activity
536 See, for example, 76 FR 67948 through 67950.
Such approaches were more focused on policies to
support monitoring of ACO performance and
ensuring program integrity.
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outside of an ACO’s control, and
thereby the related financial risk is
assumed entirely by ACOs. We view
this outcome as particularly inequitable
to ACOs because they have no direct
means of controlling such costs. Unlike
Medicare Advantage organizations,
ACOs are not responsible for processing
claims for their assigned beneficiaries
and otherwise have no means of causing
the denial of such claims. CMS thus
cannot reasonably have expected ACOs
to have intended to assume
responsibility for all instances of SAHS
billing activity outside of an ACO’s
control when they joined the Shared
Savings Program. For these reasons, it
would be contrary to the public interest
for CMS to fail to apply a policy
mitigating this issue retroactively.
We did not foresee the acute need to
address SAHS billing activity impacting
CY 2023, and the need for the related
policy proposal for addressing SAHS
billing activity in CY 2024 or
subsequent calendar years, with
sufficient time in advance of the start of
PY 2024 to undertake notice and
comment rulemaking earlier, and to
avoid retroactive rulemaking. More
specifically, we were only able to
determine that the increase in billing on
HCPCS codes A4352 and A4353 in CY
2023 represented SAHS billing activity
after the calendar year ended. To
identify that the billing activity in CY
2023 was significant, anomalous, and
highly suspect, CMS reviewed actual
billing levels after the calendar year
closed and services furnished in CY
2023 had occurred and the billing level
could then be compared to billing levels
observed in prior calendar years.
We seek comment on our proposal to
apply the policy retroactively to PY
2024, including whether failing to apply
the policy retroactively would be
contrary to the public interest and how
it would affect ACOs and their ability to
participate in the Shared Savings
Program.
We are proposing a new § 425.672 to
describe adjustments CMS could make
to Shared Savings Program calculations
to mitigate the impact of SAHS billing
activity for CY 2024 or subsequent
calendar years. We propose that
§ 425.672(b) specify that CMS, at its sole
discretion, may determine that the
billing of specified HCPCS or CPT codes
represents SAHS billing activity in
calendar year 2024 or subsequent
calendar years that warrants adjustment
to calculations made under this part. We
propose under § 425.672(c) to specify
the Shared Savings Program
calculations for which CMS would
exclude all Medicare Parts A and B FFS
payment amounts for the specified
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claim types associated with a HCPCS or
CPT code identified in § 425.672(b)
when an adjustment to the calculation
is appropriate in light of the SAHS
billing activity. The calculations
specified in § 425.672(c) include all
potentially relevant financial
calculation provisions, including those
covering the financial benchmarking
methodologies (including the proposed
HEBA scaler at § 425.662(b)(2)) and
those covering calculation of shared
savings and losses. We propose in
§ 425.672(d) that for calendar year 2024
or subsequent calendar years,537 CMS
would adjust Shared Savings Program
calculations for SAHS billing activity
identified under § 425.672(b) for the
calendar year when it is either a
performance year or a benchmark year,
as well as the 3 most recent years prior
to the start of the ACO’s agreement
period used in establishing the
historical benchmark, when such a
benchmark is used to reconcile the ACO
for a performance year adjusted for
SAHS billing activity. We propose to
specify under § 425.672(e) that we
would also make adjustments for any
calendar year corresponding to BY3 in
projecting per capita growth in
Medicare Parts A and B FFS
expenditures according to
§ 425.660(b)(1) for purposes of
calculating the ACPT for agreement
periods beginning on January 1, 2024,
and in subsequent years. Additionally,
we are proposing conforming revisions
to §§ 425.601(a)(9) and 425.652(a)(9), as
well as proposing new paragraphs at
§§ 425.601(a)(9)(iv) and 425.652(a)(9)(ix)
to include adjustments for SAHS billing
activity as one of the reasons that CMS
would adjust an ACO’s benchmark
during the term of its agreement period.
While we expect that the identification
of SAHS billing activity that triggers
these proposed policies will be rare, we
believe that, if finalized, these policies
will allow us to proactively ensure the
accuracy of program calculations and
provide greater certainty for ACOs and
the Trust Funds.
We seek comment on these proposals.
537 We note that by anchoring this policy on the
calendar year, this proposed provision differs from
many other program regulations that are applicable
for a given performance year or for agreement
periods beginning on a given date or within a given
range. However, we believe this approach is
appropriate for this policy as (1) we would adjust
expenditures for the affected calendar year both
when it is a performance year and when it is a
benchmark year and (2) it ties the policy to the
period for which the SAHS billing activity was
identified much in the way the policy for COVID–
19 episodes of care specified in § 425.611 is tied to
the related public health emergency.
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e. Seeking Comment on Establishing
Higher Risk and Potential Reward
Under the ENHANCED Track
(1) Background
As described in the CY 2024 PFS final
rule (88 FR 79223), 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) and that
builds on the experience of the Next
Generation ACO (NGACO) and ACO
REACH Models. A higher risk track
would offer ACOs increased incentives
to generate savings, which would help
improve care delivery by promoting
innovations in the delivery of highquality care that is more patientcentered. In other words, by increasing
sharing rates for ACOs, ACOs will be
better incentivized to develop
innovations in the delivery of highquality care and, therefore, improve the
care they offer to their beneficiaries. A
revised ENHANCED track could be
implemented in accordance with
section 1899(i)(3) of the Act, provided
the Secretary determines that such other
payment model enhances the quality
and efficiency of items and services
furnished under the Medicare program
and does not result in program
expenditures greater than those that
would result under the statutory
payment model.
In the CY 2024 PFS final rule (88 FR
79223), we summarized public
comments received in response to our
Request for Information (RFI) regarding
a potential track within the Shared
Savings Program with higher risk than
the current ENHANCED track. For a full
summary of the comments submitted in
response to our comment solicitation,
we refer readers to the relevant
discussion in the CY 2024 PFS final rule
(88 FR 79225 through 79227).
Commenters were broadly supportive of
such an approach and referenced
existing policies under the ACO REACH
Model, and the NGACO Model. Some
commenters suggested features of such
a track that would serve to encourage
more participation in the Shared
Savings Program and help ACOs deliver
more person-centered care to
beneficiaries in Traditional Medicare.
These features included prospective
payments, full sharing rates (a sharing
rate of 100 percent, similar to the Global
Risk Sharing Option in the ACO REACH
Model) as well as a benchmark discount
rate (a reduction of the benchmark by a
predetermined percentage) to protect
the Medicare Trust Funds.
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A higher risk sharing arrangement
could incentivize participating ACOs to
improve performance in the program as
they would receive a greater share of
any gross savings. That improved
performance may, in turn, result in
reduced healthcare costs for Medicare
and more effective, efficient care for
beneficiaries. In addition, higher risk
sharing could incentivize ACOs to
develop new care delivery strategies in
order to improve their financial
performance, 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 currently participating
ACOs to continue participation in the
Shared Savings Program, as well as
encourage ACOs not participating in the
Shared Savings Program to join as a
result of increased potential reward.
A recent CBO report 538 proposed that
higher sharing rates might incentivize
providers to decrease spending as they
would stand to gain a larger portion of
the savings generated. While in the
short term this might diminish CMS
savings, the report postulates that this
would increase participation in the
Shared Savings Program and provide a
means for CMS to manage long-term
healthcare spending growth. The report
also highlights the necessity of striking
a delicate balance: devising financial
incentives enticing enough for ACOs to
participate actively in the Shared
Savings Program, while ensuring that
such participation leads to savings for
the Medicare program.
We seek comment on a participation
option that would allow for higher risk
and reward than currently available
under the ENHANCED track. A
participation option of this type would
replace the existing ENHANCED track
in order to avoid the self-selection
issues that would occur if a higher risk
track were to be included alongside the
ENHANCED track. If both participation
options were made available to ACOs,
we have concerns that only the highestperforming ACOs would self-select into
the higher of the two risk tracks. While
we included an RFI on the topic in CY
2024 PFS rulemaking, we are concerned
that ACOs did not have enough detailed
information to appropriately weigh the
538 For more details, please refer to Congressional
Budget Office (CBO), ‘‘Medicare Accountable Care
Organizations: Past Performance and Future
Directions’’, April 2024, available at https://
www.cbo.gov/system/files/2024-04/59879-MedicareACOs.pdf.
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tradeoffs associated with a higher risk/
reward option than the current
ENHANCED track, and that the
additional information we have
generated since then will allow ACOs
and other interested parties to provide
more forthright and helpful feedback.
CMS is interested in public comments
on the design of a higher risk option
within the Shared Savings Program that
could be enacted under our authority
granted by section 1899(i)(3) of the Act
and that would encourage ACOs to
participate actively in the Shared
Savings Program while ensuring that
such participation leads to savings for
the Medicare program.
(a) Current ENHANCED Track
Currently, under the Shared Savings
Program, ACOs may enter participation
agreements under the ENHANCED
track. The ENHANCED track is a twosided 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. 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, subpart
B (§§ 425.100 through 425.118). For
ACOs meeting the applicable quality
performance standard established under
§ 425.512(a)(2) or (a)(5)(i) (for PY 2024
and subsequent performance years), the
final shared savings rate is equal to the
maximum sharing rate of 75 percent, or
savings at a rate of 75 percent
multiplied by the ACO’s health equity
adjusted quality performance score if
the ACO meets the alternative quality
performance standard at
§ 425.512(a)(5)(ii). 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 20 percent of the
updated benchmark (§ 425.610(e)(2)).
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
(§ 425.100(c)). Once this MLR is met or
exceeded, the ACO will share in losses
at a rate determined according to the
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ACO’s track/level of participation, up to
a loss recoupment limit (also referred to
as the loss sharing limit) (§ 425.605(d);
§ 425.610(f), (g)). In determining shared
losses, ACOs participating in the
ENHANCED track are subject to losses
at a rate determined using a sliding
scale based on ACO’s health equity
adjusted quality performance score, if
the applicable quality performance
standard established in § 425.512(a)(2)
or (a)(5)(i) or the alternative quality
performance standard at
§ 425.512(a)(5)(ii) is met; with minimum
shared loss rate of 40 percent and
maximum of 75 percent. If the ACO fails
to meet the applicable quality
performance standard established in
§ 425.512 or the alternative quality
performance standard, the ACO is
subject to 1st dollar losses at a rate of
75 percent (§ 425.610(f)(4)(ii)). Shared
losses are subject to a cap that is equal
to 15 percent of updated benchmark
(§ 425.610(g)).
CMS adjusts historical benchmark
expenditures by Medicare enrollment
type by a percentage of the difference
between the average per capita
expenditure amount for the ACO’s
regional service area and the ACO’s
historical benchmark amount (referred
to herein as the ‘‘regional adjustment’’)
(§ 425.652(a)(8)). The weights used in
the regional adjustment calculation are
determined in accordance
with§ 425.656(e) and are dependent 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. The first time
that an ACO’s benchmark is adjusted
based on the ACO’s regional service area
expenditures, CMS calculates the
regional adjustment using either 35
percent of the difference between the
average per capita amount of
expenditures for the ACO’s regional
service area and the average per capita
amount of the ACO’s initial or rebased
historical benchmark, if the ACO is
determined to have lower spending than
the ACO’s regional service area
(§ 425.656(e)(1)(i)); or 15 percent of the
difference between the average per
capita amount of expenditures for the
ACO’s regional service area and the
average per capita amount of the ACO’s
initial or rebased historical benchmark,
if the ACO is determined to have higher
spending than the ACO’s regional
service area (§ 425.656(e)(1)(ii)). The
second time that an ACO’s benchmark is
adjusted based on the ACO’s regional
service area expenditures, CMS
calculates the regional adjustment using
either the 50 percent of the difference
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between the average per capita amount
of expenditures for the ACO’s regional
service area and the average per capita
amount of the ACO’s rebased historical
benchmark if the ACO is determined to
have lower spending than the ACO’s
regional service area (§ 425.656(e)(2)(i));
or 25 percent of the difference between
the average per capita amount of
expenditures for the ACO’s regional
service area and the average per capita
amount of the ACO’s rebased historical
benchmark if the ACO is determined to
have higher spending than the ACO’s
regional service area (§ 425.656(e)(2)(ii)).
The third time that an ACO’s benchmark
is adjusted based on the ACO’s regional
service area expenditures, CMS
calculates the regional adjustment using
the 50 percent of the difference between
the average per capita amount of
expenditures for the ACO’s regional
service area and the average per capita
amount of the ACO’s rebased historical
benchmark if the ACO is determined to
have lower spending than the ACO’s
regional service area (§ 425.656(e)(3)(i));
or the 35 percent of the difference
between the average per capita amount
of expenditures for the ACO’s regional
service area and the average per capita
amount of the ACO’s rebased historical
benchmark if the ACO is determined to
have higher spending than the ACO’s
regional service area (§ 425.656(e)(3)(ii)).
The fourth or subsequent time that an
ACO’s benchmark is adjusted based on
the ACO’s regional service area
expenditures, CMS calculates the
regional adjustment to the historical
benchmark using 50 percent of the
difference between the average per
capita expenditures for the ACO’s
regional service area and the average per
capita amount of the ACO’s rebased
historical benchmark (§ 425.656(e)(4)).
Among the ACOs participating in PY
2024, 78 percent of BASIC track ACOs
(176 of 227) received a positive regional
adjustment, whereas 95 percent (155 of
163) of ACOs in the ENHANCED track
received a positive regional adjustment.
A positive regional adjustment indicates
that their expenditures were less than
that of their regional service area. For
ACOs receiving a positive regional
adjustment, the average regional
adjustment amount was 2.21 percent
($237) of historical benchmark
expenditures.
As of January 1, 2024, 43 percent (207
of 480) Shared Savings Program ACOs
are participating under the ENHANCED
track. Under Shared Savings Program
policies, all ACOs participating in a
two-sided model can select a
symmetrical MSR and MLR which
applies for the duration of its agreement
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period (§ 425.605(b)(2); § 425.610(b)(1)).
Among ACOs participating in the
ENHANCED track for PY 2024, 61
percent (126 of 207) have selected an
MSR/MLR of 0.5 percent or greater
while 39 percent (81 of 207) have
selected an MSR/MLR of 0.0 percent.
Among ACOs that participated in the
ENHANCED track for PY 2022, 38
percent (55 of 146) generated gross
savings between zero and 5 percent of
their updated benchmark expenditures,
and 12 percent (17 of 146) generated
gross savings of 10 percent or more of
their benchmark expenditures.
(b) Other CMS Innovation Center
Models
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. Under the 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 increase the likelihood
that any savings achieved by the
NGACOs participating in the model
would also result in savings for the
Medicare Program. The NGACO Model
evaluation found that while NGACOs
reduced gross Medicare Parts A and B
expenditures relative to a comparison
group of similar fee-for-service Medicare
beneficiaries in their markets, they did
not generate savings to the Medicare
Trust Funds. ACOs that elected a risk
cap greater than 5 percent and
participated in model population-based
payment mechanisms achieved greater
declines in spending, suggesting that the
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combination of risk and payment flows
is impactful. Spending reductions grew
larger almost every year, reflecting a
combination of NGACOs’ improvements
in infrastructure and clinical processes,
exit by poorer-performing NGACOs, and
the COVID–19 pandemic. While the
NGACO Model reduced spending in
Medicare Parts A and B, CMS paid back
these reductions in the form of shared
savings payments to ACOs. These
results highlight the need to balance the
tradeoff between incentivizing
participation in higher levels of risk and
reward, in alternative payment models
such as the Shared Savings Program and
ACO models tested by the Innovation
Center, and reducing the risk of loss to
the Medicare Trust Funds.
Under the ACO REACH Model,
REACH ACOs are offered the choice of
participating under the Global or the
Professional Risk Sharing Options. As in
the NGACO Model, under both risk
sharing options, the REACH ACO is
responsible for 100 percent of
performance year expenditures for
services rendered to aligned
beneficiaries. Because ACOs electing the
Global Risk Sharing Option retain up to
100 percent of the savings/losses on all
savings up to 25 percent of their
benchmark, with reduced sharing rates
for savings exceeding 25 percent of their
benchmark, a discount is applied to the
benchmark to ensure savings are also
generated for CMS. For ACOs in the
Global Risk Sharing Option, the
benchmark is reduced by a fixed
percentage based on the performance
year.539 The discount rate for PYs 2021
and 2022 was 2 percent, for PYs 2023
and 2024 is 3 percent, and for PYs 2025
and 2026 will be above 3.5 percent. The
benchmark for ACOs participating in
the Professional Risk Sharing 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.
Preliminary evaluation results of the
first 2 performance years of the Global
and Professional Direct Contracting
Model, before its transition to the ACO
REACH Model, suggest that
participating ACOs had mixed results in
gross spending but consistent,
significant increases in net spending
relative to a comparison group of similar
FFS Medicare beneficiaries in their
markets, which included beneficiaries
assigned to ACOs participating in the
539 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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Shared Savings Program. Standard
ACOs, comprised of organizations that
generally have experience serving
Medicare FFS beneficiaries, increased
gross spending. Standard ACOs also
reduced acute care spending and
utilization but comparison providers
had larger reductions in acute care
spending and utilization. Increased
spending among Standard ACOs was
concentrated among the integrated
delivery system/hospital system ACOs
in the model. High Needs ACOs that
serve Medicare FFS beneficiaries with
complex needs, including dually
eligible beneficiaries, decreased gross
spending. High Needs ACOs comprised
of organizations that have not
traditionally provided services to
Medicare FFS beneficiaries favorably
reduced acute and post-acute care
utilization and spending. New Entrant
ACOs had declines in gross spending
but these declines were similar to those
of providers within their same markets.
Standard and New Entrant ACOs
showed statistically significant
improvement on at least one quality
measure. These interim evaluation
results are mixed, and additional
analyses and years of experience with
the Model will inform which features of
ACO REACH could drive continued
growth and innovation in the Shared
Savings Program and the focus of future
Innovation Center ACO models.
(2) Considerations for Incorporating
Higher Risk and Potential Reward
Under the ENHANCED Track
As we explained in the CY 2024 PFS
final rule (88 FR 79223 through 79225),
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 and increase ACO participation
in the Shared Savings Program and in
two-sided risk tracks, all while ensuring
sufficient financial safeguards to protect
against inappropriately large shared
losses for ACOs coordinating and
improving quality of care for high-cost
beneficiaries. Considerations must also
be directed towards safeguarding the
Medicare Trust Funds and ensuring that
CMS satisfies any statutory
requirements under section 1899(i)(3) of
the Act.
A revised ENHANCED track could be
implemented in accordance with
section 1899(i)(3) of the Act, provided
the Secretary determines that such other
payment model enhances the quality
and efficiency of items and services
furnished under the Medicare program
and does not result in program
expenditures greater than those that
would result under the statutory
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payment model. Increasing the sharing
rate in the ENHANCED track may need
to be accompanied by other
modifications to prevent spending from
increasing and possibly jeopardizing
compliance with section 1899(i)(3) of
the Act. One factor to consider is
selective participation with regard to
which ACOs would choose to
participate in a higher risk track, if
offered. For example, Shared Savings
Program ACOs that have a history of
high levels of earned 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. This could result in increased
spending on the part of CMS which may
jeopardize compliance with section
1899(i)(3) of the Act. If a higher risk
track were to be offered in the Shared
Savings Program in the future, CMS
would consider replacing the existing
ENHANCED track in order to prevent
further selective participation and
maintain the balance between increased
participation and compliance with
applicable statutory requirements.
We are seeking comment on the
following potential features of a revised
ENHANCED track:
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(a) Benchmark Discount Rate
Both the NGACO Model and the
Global Risk Sharing Option of the ACO
REACH Model feature a discount rate
that is applied to benchmarks. The
discount rate serves to protect the
Medicare Trust Funds by reducing
benchmarks and thereby improves the
likelihood of achieving savings for the
Medicare program for risk tracks that
can feature up to 100 percent shared
savings rates, such as the Global Risk
Sharing Option in the ACO REACH
Model. A discount would be applied to
an ACO’s updated historical benchmark
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before gross savings/losses are
calculated, which increases the
likelihood of savings for CMS and the
Medicare program. If an ACO were to
participate in a potential higher risk
track and potentially share in 100
percent of gross savings, this discount
would serve as the primary means for
CMS to capture savings from ACOs
participating in this option, as in the
absence of a discount any and all gross
savings would go to ACOs in the form
of a shared savings payment. For
example, consider an ACO with an
updated benchmark of $10,000 and
mean per-capita performance year
expenditures of $9,500. Applying a
discount rate of 1 percent to the
benchmark would reduce the ACO’s
benchmark to $9,900. Gross savings
would then be calculated based on the
discounted benchmark, and the ACO’s
shared saving rate would be applied to
the savings, provided these savings met
or exceeded the ACO’s selected MSR.
A discount to the benchmark could
also include a guardrail policy similar to
the guardrail implemented in the threeway blended update factor that was
finalized in the CY 2023 PFS final rule
(87 FR 69881). Under such an approach,
if an ACO were to be liable for shared
losses after discounting the benchmark,
then gross savings or losses would be
recalculated using a benchmark without
the discount. However, if the ACO were
to generate gross savings in excess of
their MSR under the benchmark without
the discount, they would still not be
considered eligible to share in savings.
This approach would help ensure that
CMS shares in any savings generated by
ACOs participating in a potential
revised ENHANCED track while also not
increasing downside risk for ACOs that
may be liable for shared losses.
We seek comment on what rate would
be appropriate for a discount to the
benchmark that would protect the
Medicare Trust Funds while providing
an adequate incentive for ACOs to
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participate in a potential revised
ENHANCED track. We also seek
comment on whether the model features
described in following subsections
might replace a discount to the
benchmark while balancing financial
incentives for ACOs and risk to CMS.
Additionally, we also seek comments
from interested parties, including ACOs,
on the discount to the benchmark and
what level of discount would be
acceptable to ACOs participating in the
Shared Savings Program, as well as
what would be considered too high of
a discount.
(b) Tapered Sharing Arrangements
Currently in the ENHANCED track,
ACOs can receive a shared savings
payment of up to 20 percent of their
updated benchmark (once the MSR is
met or exceeded) (§ 425.610(e)(2)) or be
liable for losses not to exceed 15 percent
of their updated benchmark (once the
MLR is met or exceeded) (§ 425.610(g)).
Alternatively, CMS could set up
marginal savings bands or risk corridors
under which shared savings or losses
rates would vary with the amount of
gross savings or losses. As gross savings/
losses increase, the ACO will retain a
progressively smaller portion of the total
savings or will be responsible for a
progressively smaller portion of the total
losses. For example, consider
hypothetical marginal savings bands
shown in Table 44. Under this
arrangement, an ACO would share in all
savings up to 10 percent of their
updated benchmark at a rate of 100
percent. For savings between 10 to 15
percent, the ACO would share in 60
percent of savings and CMS would
retain the remaining 40 percent. For
savings between 15 to 20 percent, the
ACO would share in 40 percent of
savings and CMS would retain the
remaining 60 percent. In case of losses,
ACOs would be responsible for 50–100
percent of the losses, depending on the
ACO’s quality performance score.
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TABLE 44: Hypothetical Marginal Shared Savings Bands
Gross savings as % of benchmark
Shared Savings/Loss Rate1
0-10%
100%
10-15%
60%
15-20%
40%
>20%
0%
Losses
50%- 100%2
1 Percentage of savings or losses retained by the ACO.
Loss Rate would depend on anACO's quality performance, similar to§ 425.610(£)(4).
We seek comment on whether the
hypothetical marginal shared savings
bands shown in Table 44 represent an
appropriate tapering schedule that
would provide sufficient incentive for
an ACO to participate in a potential
revised ENHANCED track, as well as
whether the tapering schedule should
begin with lower shared savings rates
and feature increasing rates as an ACO
generates greater amounts of savings.
We also seek comment on whether a
potential tapering schedule should be
symmetrical with respect to shared loss
rates. Finally, we seek comment on
whether marginal shared savings bands
provide the right incentives to ACOs
relative to the fixed savings rate in the
current ENHANCED track.
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(c) MSR/MLR
We are considering the option for all
ACOs under a revised ENHANCED track
to be subject to a symmetric MSR/MLR
of 0 percent. This would increase many
ACOs’ exposure to both positive savings
and negative risk. While this approach
would guarantee that any ACO
generating savings would share in those
savings (provided they meet the quality
performance standard established under
§ 425.512 and otherwise maintain their
eligibility to participate in the Shared
Savings Program), ACOs with
performance year expenditures greater
than their historical benchmark would
be liable for those losses due to the 0
percent MLR. We are seeking comment
on whether a potential revised
ENHANCED track should retain the
existing symmetric MSR/MLR selection
options that currently exist for ACOs in
a two-sided risk model under
§ 425.610(b)(1).
(d) Cap On Regional Adjustment Weight
We are seeking comment on adjusting
the weights used to calculate the
regional adjustment amounts under
§ 425.656(e) for ACOs in the revised
ENHANCED track. This may take the
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form of applying a cap of 35 percent to
all the weights used to calculate
regional adjustment amounts. This
would impact any ACOs in a second or
subsequent agreement period subject to
a regional adjustment if their historical
benchmark spending is lower than their
regional service area. If the cap were to
apply to an ACO with lower spending
than their regional service area, then
this would result in a decreased regional
adjustment to that ACO’s historical
benchmark. Overall, this feature would
reduce the cost to CMS associated with
high regional adjustments by reducing
an ACO’s historical benchmark in the
event that an ACO in a second or
subsequent agreement period receives a
large positive regional adjustment,
which may decrease the need for higher
benchmark discount rates or lower
tapered shared savings rates that are less
favorable to ACOs and limit incentives
for ACOs to transition from the BASIC
track to the revised ENHANCED track.
This feature may also increase the
relative impact of the prior savings
adjustment and the health equity
benchmark adjustment proposed in
section III.G.7.b. of this proposed rule.
We seek comment on whether further
reductions to or the removal of the
regional adjustment to the historical
benchmark would be appropriate as part
of a potential revised ENHANCED track.
We also seek comment on whether
maintaining the regional adjustment in
its current state would warrant further
changes to the revised ENHANCED
track features described above,
including, but not limited to, a discount
to the benchmark or lower tapered
shared savings rates.
(e) Payment Mechanisms
We are seeking comments on
alternative payment mechanisms the
Innovation Center has tested and their
ability to help transform care delivery
and improve health outcomes for ACOs
participating in the Shared Savings
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Program. These payment mechanisms
test whether alternative payment flows
(that is, those other than fee for service
reimbursement) facilitate better
investment in infrastructure and care
coordination and encourage innovative
downstream payment arrangements that
can improve health outcomes for
Medicare beneficiaries. The alternative
payment mechanisms on which we seek
comments are described below:
• Infrastructure Payments: Under
these arrangements, CMS makes a
payment to the ACO, in addition to FFS
reimbursement to the providers and
suppliers participating in the ACO, that
is unrelated to claims. Infrastructure
payments have been distributed either
as a lump sum or per beneficiary per
month payments. Infrastructure
payments are recouped during the
payment reconciliation process.
• Population-Based Payment, AllInclusive Population-Based Payment, or
Advance Payment Option: In this
arrangement, CMS provides a
percentage of FFS reimbursement to the
ACO in the form of a monthly payment
to support ongoing ACO activities and
provide the ACO flexibility in the types
of arrangements it enters into with
provider/suppliers. The ACO and
providers with whom it has a written
business arrangement determine
percentage reductions to the base FFS
payments to the providers interested in
this payment arrangement. Providers
participating in this option have their
FFS payments reduced by the agreed
upon percentage, which range from 1–
100 percent. CMS pays the projected
total annual amount taken out of the
base FFS rates to the ACO in monthly
payments. At the end of each
performance year, the amount of
payment paid to ACOs participating in
this type of payment option is
reconciled against the reductions
actually made to claims payments to
providers participating in these
arrangements, linking the amount of
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these payments directly to utilization
and FFS payment.
• Capitation: The ACO REACH
Model 540 tests two capitation payment
options—Primary Care Capitation and
Total Care Capitation.
The Primary Care Capitation Payment
is the payment for primary care services
provided to aligned REACH
beneficiaries by all Participant Providers
and those Preferred Providers who have
selected Primary Care Capitation
Payment. In Primary Care Capitation, a
per beneficiary, per month capitated
payment is provided to an ACO for its
aligned beneficiaries for the primary
care services provided by the ACO’s
Participant Providers and its Preferred
Providers who have opted to participate
in Primary Care Capitation Payment.
The Primary Care Capitation payment
amount is generally equal to seven
percent of the estimated total cost of
care for the ACO’s aligned population
(that is, the risk adjusted, trended, and
regionally blended benchmark).
The Primary Care Capitation payment
includes two components, Base Primary
Care Capitation and Enhanced Primary
Care Capitation. The Base Primary Care
Capitation amount is intended to cover
primary care services furnished to
aligned beneficiaries by Participant
Providers and those Preferred Providers
who have agreed to participate in
Primary Care Capitation Payment that
are thus subject to fee reductions under
Primary Care Capitation Payment. The
Enhanced Primary Care Capitation
amount, which will be recouped by
CMS in full during final financial
settlement, is intended to enable ACOs
to make upfront investments in
infrastructure, technology, tools, and
resources to support increased access to
primary care, provision of care, and care
coordination. The Primary Care
Capitation Payment is expected to
encourage greater flexibility in payment
and innovative primary care service
delivery as a means of improving the
quality and cost effectiveness of care
overall.
In Total Care Capitation, a perbeneficiary, per month capitated
payment is provided to an ACO for all
Medicare Part A and Part B services
provided to aligned beneficiaries by the
ACO’s Participant Providers and its
Preferred Providers who have opted to
participate in Total Care Capitation
payment. The Total Care Capitation
540 Refer to the ACO REACH Model Request for
Applications, available at https://www.cms.gov/
priorities/innovation/media/document/aco-reachrfa, and the ACO REACH Model PY2024 Participant
and Preferred Provider Management Guide,
available at https://www.cms.gov/files/document/
aco-reach-py24-part-pref-provider-mgmt-guide.pdf.
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payment amount reflects the estimated
total cost of care for the ACO’s aligned
population (that is, the risk adjusted,
trended, and regionally blended
benchmark) and is only available to
ACOs participating in the Global risk
option. Participant Providers and those
Preferred Providers that have elected to
participate in the ACO’s selected
capitation payment mechanism
continue to submit claims to CMS for
services provided to aligned
beneficiaries. The CMS FFS claims
processing system reduces claims
payment amounts according to the
payment reduction arrangements with
their providers. More details on ACO
REACH Model’s capitation payment
mechanisms are available here: https://
www.cms.gov/files/document/acoreach-py24-financial-ops-capitationand-payment-mechanisms.pdf.
Additionally, we are interested in
feedback on the following questions
related to implementation of a revised
ENHANCED track with higher risk and
potential reward, as well as comments
that could inform changes to the Shared
Savings Program and future Innovation
Center ACO models:
1. What would the option of a revised
ENHANCED track allow an ACO to do
that they are unable to do currently?
2. How would higher downside risk
impact an ACO’s care delivery
strategies, including advanced primary
care, behavioral health, specialty
integration, and integration with
community-based organizations to
improve health outcomes or advance
health equity?
3. How does higher downside risk
impact an ACO’s downstream provider
arrangements to further advance
incentives to reduce delivery of low
value services and the total cost of care,
and to increase savings performance?
4. What types of organizations,
including but not limited to ACOs and
providers, are interested in a higher risk
and reward option in the Shared
Savings Program?
5. What additional flexibilities or
features (for example, benefit
enhancements, advance payments,
capitation payments, etc.) would ACOs
in a revised ENHANCED track with
higher risk and potential reward want
CMS to offer to help them be successful
in improving the quality of care and
reducing costs?
6. How should a revised ENHANCED
track with higher risk and potential
reward also require additional
accountability for quality? Should ACOs
in this revised track be required to
report all payer/all patient quality
measures?
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7. Should a revised ENHANCED track
with higher risk and potential reward
require ACOs with earned shared
savings to share savings with
beneficiaries or spend a flat dollar
amount or a certain percentage on
beneficiaries in the form of items or
services not covered by original
Medicare (for example, meals, dental,
vision, hearing, or Part B cost-sharing
reductions)?
8. How should CMS consider the
discount, sharing rate, and risk corridors
or marginal savings bands in the design
of a higher risk option that can realize
savings for Medicare? Are there special
considerations that CMS should bear in
mind when thinking through such
features for different types of ACOs (for
example, low revenue, high revenue,
health system-based, safety net, etc.)?
9. How might we improve beneficiary
assignment and are there different
considerations for different types of
ACOs (for example, low revenue, high
revenue, health system-based, safety
net, etc.)?
10. What other features should CMS
consider in designing financial
benchmarks that balance prospectivity
and accuracy, and that can lead to
savings for both ACOs and Medicare?
How might administratively set
benchmarks achieve these goals and
what considerations should we bear in
mind if we test administrative
benchmarking?
11. We are interested in ways to
increase participation by healthcare
providers and suppliers in the Shared
Savings Program and future Innovation
Center ACO models, including how an
ACO model requiring provider
participation or stronger participation
incentives might be designed.
f. Proposed Technical Change for
Consistency in Financial Calculations
(1) Background
For the benchmarking methodology
applicable to agreement periods
beginning on January 1, 2024, and in
subsequent years, we cap ACO
prospective hierarchical condition
category (HCC) risk score growth
between BY3 and the performance year
(as finalized in the CY 2023 PFS final
rule, refer to 87 FR 69932 through
69946), as well as prospective HCC risk
score growth in an ACO’s regional
service area between BY3 and the
performance year (as finalized in the CY
2024 PFS final rule, refer to 88 FR 79174
through 79185). The policy to cap ACO
prospective HCC risk score growth
between BY3 and the performance year
relied on our authority granted by
section 1899(d)(1)(B)(ii) of the Act to
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adjust the benchmark for beneficiary
characteristics and such other factors as
the Secretary determines appropriate
(see 87 FR 69934). The policy 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 in
calculating the regional component of
the three-way blended benchmark
update factor required use of our
statutory authority under section
1899(i)(3) of the Act (see 88 FR 79182
and 79183).
The current regulations describe how
we cap ACO prospective HCC risk score
growth at §§ 425.605(a)(1) and
425.610(a)(2). As specified, positive
adjustments in prospective HCC risk
scores are subject to a cap equal to the
ACO’s aggregate growth in demographic
risk scores between BY3 and the
performance year (positive or negative)
plus 3 percentage points. The cap
applies to prospective HCC risk score
growth for any Medicare enrollment
type only if the ACO’s aggregate growth
in prospective HCC risk scores between
BY3 and the performance year across all
of the Medicare enrollment type exceeds
this cap. Growth in an ACO’s risk scores
by enrollment type is expressed as the
ratio of the ACO’s performance year risk
score for that enrollment type to the
ACO’s BY3 risk score for that
enrollment type. The aggregate growth
in demographic and prospective HCC
risk scores risk scores is calculated by
taking a weighted average of the risk
ratio for demographic risk scores or
prospective HCC risk scores, as
applicable, for each Medicare
enrollment type using specified weights.
The current regulations further
describe how we cap prospective HCC
risk score growth in the ACO’s regional
service area at § 425.655. As specified,
CMS determines aggregate growth in
regional prospective HCC and
demographic risk scores by calculating
growth in prospective HCC and
demographic risk scores between BY3
and the performance year for each
Medicare enrollment type, where
growth in an ACO’s regional risk score
by enrollment type is expressed as the
ratio of the performance year regional
risk score for a Medicare enrollment
type to the BY3 regional risk score for
that enrollment type. We then calculate
aggregate risk score growth by taking a
weighted average of the regional
prospective HCC or demographic risk
ratios, as applicable, across the four
Medicare enrollment types, using
specified weights. We next determine
the cap on regional risk score growth
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(refer to § 425.655(e)),541 and then
determine if the ACO’s regional risk
score growth is subject to a cap and
apply a regional risk score growth cap
adjustment factor for each Medicare
enrollment type, as applicable (refer to
§ 425.655(f)).542
When describing how we will cap
prospective HCC risk score growth in
the ACO’s regional service area in the
CY 2024 PFS final rule, we included a
footnote (see 88 FR 79178) that
indicated that the weights to be used to
compute aggregate risk score growth for
this calculation are the same as the
weights to be used when calculating
weighted average ACO prospective HCC
and demographic risk ratios under the
risk adjustment methodology for
capping ACO risk score growth adopted
in the CY 2023 PFS final rule and
codified in §§ 425.605(a)(1)(ii)(C) and
425.610(a)(2)(ii)(C). That is, it was our
intention to use the same weights in
both the regional risk score growth cap
calculation and the ACO risk score
growth cap calculation. However, in
codifying the methodology for the
regional risk score growth cap in the
new section of the regulations,
§ 425.655, we inadvertently introduced
a discrepancy.
In §§ 425.605(a)(1)(ii)(C) and
425.610(a)(2)(ii)(C), where we codified
how we will calculate aggregate risk
score growth used in determining the
cap to apply to ACO prospective HCC
risk score growth, we describe the
weight applied to the growth in
demographic or prospective HCC risk
scores for each Medicare enrollment
type as equal to the product of the
historical benchmark expenditures for
that enrollment type and the
performance year person years for that
enrollment type. In § 425.655(d)(2),
where we codified how we will
calculate aggregate risk score growth
used in determining the cap to apply to
regional prospective HCC risks score
growth, we describe the weight applied
to the growth in demographic or
541 To determine the cap on regional risk score
growth, we 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 and 3 percentage points,
then adjust the cap to reflect the ACO’s aggregate
market share.
542 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 is not subject to the cap. For these ACOs we
set the risk score growth cap adjustment factor
equal to 1 for each Medicare enrollment type. 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 next determine whether the
cap on regional risk score growth applies for each
Medicare enrollment type.
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prospective HCC risk scores for each
Medicare enrollment type as equal to
product of the ACO’s regionally
adjusted historical benchmark
expenditures (emphasis added) for that
enrollment type and the ACO’s
performance year assigned beneficiary
person years for that enrollment type.
The regulations at
§§ 425.605(a)(1)(ii)(C) and
425.610(a)(2)(ii)(C) provide that we will
use the ACO’s historical benchmark
expenditures in calculating the weights
used to cap ACO risk score growth. By
contrast, the regulations at
§ 425.655(d)(2) provide that we will use
an ACO’s regionally adjusted historical
expenditures in calculating the weights
used in the calculation of regional risk
score growth cap. As written, the
regulations text at § 425.655(d)(2) is
inconsistent with the language used in
in §§ 425.605(a)(1)(ii)(C) and
425.610(a)(2)(ii)(C) despite the fact that
we indicated in the CY 2024 PFS final
rule that we would use the same
weights in both calculations.
Additionally, it is unclear how we
would apply the calculation described
at § 425.655(d)(2) in practice. As we
describe in section III.G.7.b. of this
proposed rule, for agreement periods
beginning on January 1, 2024, and in
subsequent years, in computing an
ACO’s historical benchmark, 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
§ 425.400(a)(4)(ii). An ACO’s historical
benchmark may then be subject to a
regional adjustment (refer to § 425.656),
a prior savings adjustment (refer to
§ 425.658), or no adjustment (refer to
§ 425.652(a)(8) and (c)). This
methodology, based on policies
finalized in the CY 2023 and CY 2024
PFS final rules, under which an ACO
may receive a prior savings adjustment,
a regional adjustment, and or no
adjustment at all, differs from the
methodology that was in effect for ACOs
in an agreement period beginning on or
after July 1, 2019, but before January 1,
2024, under which all ACO historical
benchmarks incorporated a regional
adjustment (see § 425.601).
Furthermore, in section III.G.7.b. of this
proposed rule we are proposing to add
a third type of adjustment that could be
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applied to an ACO’s historical
benchmark, the health equity
benchmark adjustment. If the health
equity benchmark adjustment is
finalized as proposed, an ACO may
receive a regional adjustment, a prior
savings adjustment, a health equity
benchmark adjustment, or no
adjustment to its historical benchmark.
(2) Proposed Revisions
As we described in a footnote in the
CY 2024 PFS final rule (see 88 FR
79178), it was our intention at the time
to use the same weights to calculate the
cap for prospective HCC risk score
growth in an ACO’s regional service
area as the weights used to calculate the
cap on prospective HCC risk score
growth for the ACO. We continue to
believe that the same weights should
apply to both calculations. However, the
regulation text language is not currently
aligned among the relevant provisions
or with the preamble discussion and
may also create confusion with respect
to how CMS will compute the weights
used in setting the caps on ACO and
regional prospective HCC risk score
growth, given that some ACOs will
receive a regional adjustment to their
benchmarks, some will receive a prior
savings or, if finalized, a health equity
benchmark adjustment, and some will
receive no adjustment at all.
To address these issues, we are
proposing technical changes to the
regulation text at §§ 425.605(a)(1)(ii)(C),
425.610(a)(2)(ii)(C), and 425.655(d)(2) to
align the language describing the
calculation of the weights that will be
used to compute aggregate risk score
growth across the three provisions and
to clarify that the weight applied to the
growth in ACO and regional risk scores
for each Medicare enrollment type,
respectively, would be equal to the
product of the ACO’s historical
benchmark expenditures, adjusted in
accordance with § 425.652(a)(8), for that
enrollment type and the ACO’s
performance year assigned beneficiary
person years for that enrollment type.
That is, we would use the ACO’s
historical benchmark expenditures that
would have already been adjusted to
reflect a prior savings adjustment, a
regional adjustment, a health equity
benchmark adjustment, if finalized, or
no adjustment. Aligning the description
of the weight calculation across the
three provisions would address the
discrepancy that exists between the
current regulation text and the preamble
discussion in the CY 2024 PFS final
rule. Additionally, providing additional
detail in the description of the weight
calculation, namely by indicating that
we will use an ACO’s historical
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benchmark expenditures adjusted in
accordance with § 425.652(a)(8),
clarifies how we will operationalize the
calculation which we believe is
important, especially given the
proposed health equity benchmark
adjustment, which, if finalized, would
add greater complexity to this historical
benchmark calculation.
The technical changes that we are
proposing in this section of this
proposed rule relate to benchmark
calculations for ACOs in agreement
periods beginning on or after January 1,
2024. Although we will not implement
the proposed methodologies for the first
time until summer 2025 when we
reconcile PY 2024, these policies, if
finalized, would constitute retroactive
rulemaking because they are the
standards under which we will score
ACOs that are currently participating in
agreement periods that began on January
1, 2024, for PY 2024. Section
1871(e)(1)(A)(ii) of the Act permits a
substantive change in regulations,
manual instructions, interpretive rules,
statements of policy, or guidelines of
general applicability under Title XVIII
of the Act to be applied retroactively to
items and services furnished before the
effective date of the change if the failure
to apply the change retroactively would
be contrary to the public interest. Here,
we are proposing a technical change
that would align the regulation text with
our stated intention as described in
previous rulemaking. The current
regulation text, in combination with
related discussion in the CY 2024 PFS
final rule, fails to provide sufficient
clarity with regard to how CMS will
calculate the weights used to calculate
aggregate ACO or regional risk score
growth. While the discussion in the CY
2024 PFS final rule indicates that the
same weights should be use in both
calculations, the related regulation text
does not make this clear and,
furthermore, could raise questions for
how CMS will perform calculations
given that not all ACO historical
benchmarks will include a regional
adjustment. Failure to apply the
proposed changes to our regulations at
§§ 425.605(a)(1)(ii)(C),
425.610(a)(2)(ii)(C), and 425.655(d)(2)
retroactively would be contrary to the
public interest because it creates
unintended ambiguity in the standard
CMS will use when calculating risk
score growth. Such ambiguity may make
it difficult for ACOs and other interested
parties to understand how CMS will
perform these calculations or be
interpreted to suggest that CMS would
calculate risk score growth in a different
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manner, which was not the agency’s
intention.
We seek comment on these proposals.
8. Beneficiary Notification
Requirements
a. Proposal To Modify the Requirements
for When ACOs Must Provide the
Beneficiary Information Follow-Up
Communication
Under § 425.312(a), ACOs are
required to notify beneficiaries about
the ACO’s participation in the Shared
Savings Program, the beneficiary’s
ability to decline claims data sharing,
and the beneficiary’s ability to select a
provider for the purposes of voluntary
alignment. In the CY 2023 PFS final rule
(87 FR 69961), CMS added the
beneficiary information follow up
communication requirement under
§ 425.312(a)(2)(v), which requires an
additional follow up with a beneficiary
who has received the beneficiary
notification. In the CY 2023 PFS final
rule (87 FR 69960 through 69963), CMS
noted that the follow up communication
promotes transparency and empowers
beneficiaries to make an informed
decision in choosing a primary care
physician and how they share their
health data. The beneficiary information
follow-up communication affords the
opportunity for additional direct
engagement between the beneficiary and
the ACO, or ACO participant, and
provides a chance for a meaningful
dialog between the patient and provider
about the coordination of their care, the
benefits of receiving care from an ACO
provider/supplier (as defined in
§ 425.20), the organizational operations
of the ACO, and how data is used to
improve care and report quality
outcomes.
Currently, under § 425.312(a)(2)(v)(A),
‘‘The follow-up communication must
occur no later than the earlier of the
beneficiary’s next primary care service
visit or 180 days from the date the
standardized written notice was
provided.’’ Regulations at
§ 425.312(a)(2)(v)(B) require ACOs to
document the beneficiary information
follow-up communication in a system of
record supported by the ACO and to
make the information available to CMS
upon request.
Since CMS implemented the
beneficiary information follow-up
communication requirement, we have
received feedback from ACOs that
requiring the follow-up communication
no later than the earlier of the
beneficiary’s next primary care service
visit or 180 days from the date the
standardized written notice was
provided is difficult for ACOs to
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operationalize as they do not always
know when the beneficiary’s next
primary care service will be and in some
cases it can be very soon after the
beneficiary receives the original
beneficiary notification.
In order to address this issue and the
burden it creates, CMS is proposing to
remove the requirement that ACOs must
provide this follow up at the
beneficiary’s next primary care visit.
Specifically, we propose to modify
§ 425.312(a)(2)(v)(A) to read ‘‘The
follow-up communication must occur
no later than 180 days from the date the
standardized written notice was
provided.’’ This would provide ACOs
with more flexibility to implement their
strategy for following up with
beneficiaries after they receive the
beneficiary notice, while still providing
the opportunity for a meaningful dialog
between a beneficiary and their
provider. We seek comment on this
proposal. If finalized, this proposal
would be effective beginning January 1,
2025.
b. Limit the Distribution of the
Beneficiary Notification to Beneficiaries
Likely To Be Assigned for ACOs Under
Preliminary Prospective Assignment
With Retrospective Reconciliation
ACOs that select preliminary
prospective assignment with
retrospective reconciliation are assigned
beneficiaries in a preliminary manner
and before the start of the performance
year. Beneficiary assignment for these
ACOs is then updated quarterly based
on the most recent 12 or 24 months of
data, as applicable. This assignment
methodology is codified at
§ 425.400(a)(2). We are proposing to
limit the distribution of the beneficiary
notification under § 425.312(a)(2)(iii) to
beneficiaries who are more likely be
assigned to ACOs that select
preliminary prospective assignment
with retrospective reconciliation, when
compared to the population of
beneficiaries who must receive the
beneficiary notification under current
§ 425.312(a)(2)(iii). Please note that this
is not a proposal to modify the Shared
Savings Program’s assignment
methodology.
Currently, ACOs that select
preliminary prospective assignment
with retrospective reconciliation are
required to send a beneficiary notice to
‘‘each fee-for-service beneficiary’’ under
§ 425.312(a)(2)(iii). Under
§ 425.312(a)(2)(iii), the standardized
written notice must be furnished to ‘‘all
fee-for-service beneficiaries prior to or at
the first primary care service visit
during the first performance year in
which the beneficiary receives a
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primary care service from an ACO
participant.’’ This can result in ACOs
sending notices each year to
beneficiaries who may not ultimately be
assigned to the ACO, as there are ‘‘feefor-service beneficiar[ies]’’ to whom
ACOs must send notices under
§ 425.312(a)(2)(iii) and who are not
eligible to be assigned to those ACOs for
a variety of reasons. This policy was
intended to ensure that all beneficiaries
who receive a primary care visit from a
ACO provider/supplier receive the
beneficiary notice. However, we have
heard feedback from ACOs that this
creates confusion for the beneficiary and
unnecessary administrative work for the
ACO.
To reduce burden on ACOs and
confusion for beneficiaries, we are
proposing to update the beneficiary
notice requirement for ACOs that select
preliminary prospective assignment
with retrospective reconciliation to
focus on beneficiaries that are likely to
be assigned to the ACO. These
beneficiaries are those who received at
least one primary care service during
the assignment window or applicable
expanded window for assignment (as
defined in § 425.20) from 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), a FQHC or
RHC that is part of the ACO, or an ACO
professional in the ACO whom the
beneficiary designated as responsible for
coordinating their overall care under
§ 425.402(c).
This proposal would reduce the
burden of sending the beneficiary notice
to all ‘‘fee for service beneficiar[ies],’’
including those who ultimately would
not be eligible to be assigned to ACOs
that select preliminary prospective
assignment with retrospective
reconciliation. Specifically, we propose
to modify § 425.312(a)(2)(iii) to state in
the case of an ACO that has selected
preliminary prospective assignment
with retrospective reconciliation, the
beneficiary notice must be provided by
the ACO or ACO participant to each
beneficiary who received at least one
primary care service during the
assignment window or applicable
expanded window for assignment (as
defined in § 425.20) from 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), a FQHC or
RHC that is part of the ACO, or an ACO
professional in the ACO whom the
beneficiary designated as responsible for
coordinating their overall care under
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§ 425.402(e). Each such beneficiary must
receive a standardized written notice at
least once during an agreement period
in the form and manner specified by
CMS. The standardized written notice
must be furnished to all of these
beneficiaries prior to or at the first
primary care service visit during the
first performance year in which the
beneficiary receives a primary care
service from an ACO participant.
For ACOs that select prospective
assignment, beneficiaries are
prospectively assigned to the ACO at the
beginning of each benchmark or
performance year based on the
beneficiary’s use of primary care
services in the most recent 12 or 24
months, as applicable, for which data
are available, using the assignment
methodology described in §§ 425.402
and 425.404. See § 425.400(a)(3)(i).
Beneficiaries that are prospectively
assigned to an ACO under
§ 425.400(a)(3)(i) 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). See § 425.400(a)(3)(ii). We
note that ACOs that select prospective
assignment are subject to
§ 425.312(a)(2)(iv). Under this
regulation, ACOs that select prospective
assignment are required to furnish the
beneficiary notice to all prospectively
assigned beneficiaries once during an
agreement period. We seek comment on
this proposal. If finalized, this proposed
change would be effective beginning on
January 1, 2025.
H. Medicare Part B Payment for
Preventive Services (§§ 410.10, 410.57,
410.64, 410.152)
1. Part B Preventive Vaccines and Their
Administration
a. Statutory Background
Under section 1861(s)(10) of the Act,
Medicare Part B covers both the vaccine
and vaccine administration for the
specified preventive vaccines—
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
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product, except when 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, are not specified for Medicare
Part B coverage under section
1861(s)(10) of the Act and are instead
covered under Medicare Part D.
b. Pneumococcal, Influenza and
Hepatitis B Vaccine Administration
In the CY 2022 PFS final rule (86 FR
65185), 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 payment policies
for the administration of the preventive
vaccines described under section
1861(s)(10) of the Act are 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 describe the services
to administer an influenza,
pneumococcal, and hepatitis B vaccine,
respectively.
In the CY 2023 PFS final rule (87 FR
69984), we finalized a policy to
annually update 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.
These adjustments and updates also
apply to Current Procedural
Terminology (CPT) code 90480
(Immunization administration by
intramuscular injection of severe acute
respiratory syndrome coronavirus 2
(SARSCoV–2) (coronavirus disease
[COVID–19]) vaccine, single dose) that
describe the service to administer
COVID–19 vaccines and HCPCS code
M0201 (Administration of
pneumococcal, influenza, hepatitis b,
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and/or covid–19 vaccine inside a
patient’s home; reported only once per
individual home per date of service
when such vaccine administration(s) are
performed at the patient’s home),
discussed below in section III.H.1.c and
III.H.1.d, respectively, of this proposed
rule.
The current payment rates for G0008,
G0009, and G0010, as finalized in the
CY 2024 PFS final rule, can be found on
the CMS Vaccine Pricing website under
the ‘‘Seasonal Flu Vaccines’’ tab, and
then under the heading ‘‘LocalityAdjusted Payment Rates.’’ 543 The
payment rates for these services, with
the annual update applied for CY 2025,
will be made available at the time of
publication of the CY 2025 PFS final
rule. The current forecast of the increase
in the MEI for CY 2025 is 3.6 percent
based on the 2017-based MEI. We note
that the CY 2025 MEI increase factor for
the final rule will be based on historical
data through the 2nd quarter of 2024.
Tables 45 and 46 in section III.H.1.f. of
this proposed rule provide the CY 2025
projected payment rates for G0008,
G0009, and G0010.
c. COVID–19 Vaccine Administration
In the CY 2022 PFS final rule (86 FR
65181 and 65182), we provided a
detailed history regarding the
determinations of initial payment rates
for the administration of COVID–19
vaccines, and an explanation of how the
payment policy evolved to a rate of $40
per dose. For CY 2022, we maintained
the payment policy for the
administration of COVID–19 vaccines
and stated that while we believe it is
appropriate to establish a single,
consistent payment rate for the
administration of all four Part B
preventive vaccines in the long term, we
will 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
due to 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
543 https://www.cms.gov/medicare/payment/feefor-service-providers/part-b-drugs/average-drugsales-price/vaccine-pricing, under the tab ‘‘Seasonal
Flu Vaccines’’, and then under the header
‘‘Locality-Adjusted Payment Rates.’’
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with respect to payment for
administration of these products, as
addressed in the November 6, 2020
COVID–19 IFC (85 FR 71142) and CY
2022 PFS final rule (85 FR 18250),
continue until the EUA declaration for
drugs and biological products with
respect to COVID–19 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 payment would be set at
a rate to align with the payment rate for
the administration of other Part B
preventive vaccines, that is,
approximately $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.
On September 11, 2023, the Food and
Drug Administration (FDA) announced
its recommendation to shift to a
monovalent severe acute respiratory
syndrome coronavirus 2 (SARS–CoV–2)
(coronavirus disease 2019 [COVID–19])
vaccine that targets the predominant
XBB lineage virus strain for the 2023–
2024 vaccine administration season.544
In anticipation of this recommendation,
in August 2023, the CPT Editorial Panel
approved five new monovalent COVID–
19 vaccine product codes for Pfizer and
Moderna vaccines. In addition, they
approved a new vaccine administration
code (90480) for reporting the
administration of any COVID–19
vaccine for any patient (pediatric or
adult), replacing all previously
approved specific vaccine
administration codes. All previously
approved COVID–19 vaccine product
and vaccine administration codes were
deleted from the CPT code set effective
November 1, 2023, except for product
code 91304, which represents the
544 https://www.fda.gov/news-events/pressannouncements/fda-takes-action-updated-mrnacovid-19-vaccines-better-protect-against-currentlycirculating.
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Novavax COVID–19 vaccine product
and remains active.545
The current payment rate for CPT
code 90480 is available on the CMS
COVID–19 Vaccine Pricing website,
under ‘‘COVID–19 Vaccines &
Monoclonal Antibodies’’.546 The
payment rate for this service, with the
annual update applied for CY 2025, will
be made available at the time of
publication of the CY 2025 PFS final
rule. As noted above, the current
forecast of the increase in the MEI for
CY 2025 is 3.6 percent based on the
2017-based MEI, however, the CY 2025
MEI increase factor for the final rule
will be based on historical data through
the 2nd quarter of 2024.
Due to the uncertainty surrounding
the future of the EUA declaration for
drugs and biological products for
COVID–19, Tables 45 and 46, at the end
of section III.H.1.f. of this proposed rule,
reflect the potential alternative payment
amounts for Part B preventive vaccine
administration for CY 2025. Table 45
displays the CY 2025 Part B payment
rates for preventive vaccine
administration if the EUA declaration
continues into CY 2025, and Table 46
displays the CY 2025 Part B payment
rates for preventive vaccine
administration if the EUA declaration
ends on or before December 31, 2024.
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d. In-Home Additional Payment for
Administration of Preventive Vaccines
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, could bill Medicare for
one of the existing COVID–19 vaccine
administration CPT codes 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). For CY 2022, we
continued to make an additional
payment when a COVID–19 vaccine was
administered in a beneficiary’s home
under certain circumstances and stated
that we would make this payment until
the end of the year in which the PHE
expires.
545 CPT® Assistant Special Edition: August
Update/Volume 33/2023. https://www.amaassn.org/system/files/cpt-assistant-guidecoronavirus-august-2023-updated.pdf.
546 https://www.cms.gov/medicare/payment/feefor-service-providers/part-b-drugs/average-drugsales-price/vaccine-pricing, under ‘‘COVID–19
Vaccines & Monoclonal Antibodies’’.
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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
for underserved homebound
beneficiaries. Therefore, we continued
the policy of making an additional
payment when a COVID–19 vaccine is
administered in a beneficiary’s home,
under the certain circumstances for the
duration of CY 2023. We explained that
we were continuing the policy of
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. In
addition, for CY 2023 we updated the
payment amount by the CY 2023 MEI
percentage increase and adjusted 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 (87 FR 69986).
In the CY 2024 PFS final rule (88 FR
79235 through 79237), we discussed the
policy for the in-home additional
payment for COVID–19 vaccine
administration under the Part B
preventive vaccine benefit for CY 2024
and subsequent years. We maintained
the payment policy for COVID–19
vaccine administration and extended
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. As described at
§ 410.152(h)(3), effective January 1,
2024, the payment amount for the inhome administration of all four vaccines
is identical, that is, Medicare Part B
pays the same additional payment
amount to providers and suppliers that
administer a pneumococcal, influenza,
hepatitis B, or COVID–19 vaccine in the
home. This additional payment amount
is annually updated using the
percentage increase in the MEI and is
adjusted to reflect geographic cost
variations with the PFS GAF.
We stated that the in-home additional
payment is limited to one payment per
home visit, even if multiple vaccines are
administered during the same home
visit. We noted that every vaccine dose
that is furnished during a home visit
still receives its own unique vaccine
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administration payment. The additional
payment for in-home Part B vaccine
administration is only made if certain
circumstances are met, as outlined at
§ 410.152(h)(3)(iii). Providers and
suppliers that administer one of the Part
B preventive vaccines in the home,
under those circumstances, can bill
Medicare for one of the existing Part B
vaccine administration CPT codes along
with HCPCS code M0201
(Administration of pneumococcal,
influenza, hepatitis b, and/or covid–19
vaccine inside a patient’s home;
reported only once per individual home
per date of service when such vaccine
administration(s) are performed at the
patient’s home) (88 FR 79235 through
79237).
The current payment rate for M0201
can be found on the CMS Vaccine
Pricing website under ‘‘COVID–19
Vaccines & Monoclonal Antibodies’’.547
The M0201 payment rate with the
annual update applied for CY 2025 will
be made available at the time of
publication of the CY 2025 PFS final
rule. The current forecast of the increase
in the MEI for CY 2025 is 3.6 percent
based on the 2017-based MEI. We note
that the CY 2025 MEI increase factor for
the final rule will be based on historical
data through the 2nd quarter of 2024.
Tables 45 and 46 in section III.H.1.f. of
this proposed rule provide the CY 2025
projected payment rate for M0201.
e. COVID–19 Monoclonal Antibodies
and Their Administration
In CY 2023 PFS final rule (87 FR
69987 through 69993), 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).
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–
547 https://www.cms.gov/medicare/payment/feefor-service-providers/part-b-drugs/average-drugsales-price/vaccine-pricing, under ‘‘COVID–19
Vaccines & Monoclonal Antibodies’’.
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19 under the Part B preventive vaccine
benefit if they meet applicable coverage
requirements (87 FR 69992). We
explained that we will 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. In the CY 2024 PFS rule (88
FR 79239 through 79240), we codified
these policies in regulations at
§§ 410.10(l) and 410.57(c).
In CY 2024 PFS final rule (88 FR
79239 through 79240), we noted that we
did not finalize any payment regulations
regarding monoclonal antibodies for
PrEP of COVID–19, since at the time of
the publication of the CY 2024 PFS final
rule, there were no COVID–19
monoclonal antibodies approved or
authorized for use against the dominant
strains of COVID–19 in the United
States. We stated that if a new
monoclonal antibody for PrEP of
COVID–19 became 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 explained that we would
subsequently propose coding and
payment rates for the administration of
that product via rulemaking.
We also noted that, for the purposes
of the in-home additional payment
discussed above in section III.H.1.d. of
this proposed rule, that additional
payment is not applicable to the
administration of monoclonal
antibodies for PrEP of COVID–19. For
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monoclonal antibodies for PrEP of
COVID–19, we set the coding and
payment rates for the administration of
COVID–19 monoclonal antibodies in the
home (when applicable) 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.
On March 22, 2024, the FDA issued
an EUA for Pemgarda (pemivibart)
injection, for intravenous use.548
Pemgarda is a monoclonal antibody
product indicated for use for preexposure prophylaxis to help prevent
COVID–19 in adults and children 12
years of age and older who weigh at
least 88 pounds (40 kg) who:
• Are not currently infected with
SARS–CoV–2 and who have not been
known to be exposed to someone who
is infected with SARS–CoV–2 and
• Have moderate-to-severe immune
compromise because of a medical
condition or because they receive
medicines or treatments that suppress
the immune system and they are
unlikely to have an adequate response
to COVID–19 vaccination.
Therefore, under the authority
provided by section 3713 of the CARES
Act, we established specific coding and
payment rates for the administration of
Pemgarda through technical direction to
MACs and information posted publicly
on the CMS website. Since Pemgarda is
used for pre-exposure prophylaxis of
COVID–19, which CMS is covering
under the Part B preventive vaccine
benefit even after the EUA declaration
for drugs and biological products is
terminated (so long as such products
still have market authorization), we plan
to propose long-term coding and
payment rates for the administration of
this product in future rulemaking. The
current payment rates for Pemgarda and
its administration can be found on the
548 https://www.fda.gov/media/177068/
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CMS Vaccine Pricing website under
‘‘COVID–19 Vaccines & Monoclonal
Antibodies’’.549 These payment rates are
also listed below in Tables 45 and 46.
More information on our coding and
payment policies for COVID–19
monoclonal antibodies is available at
https://www.cms.gov/monoclonal.
f. Summary of Payment Amounts for CY
2025
Due to the uncertainty surrounding
the future of the EUA declaration for
drugs and biological products for
COVID–19, we are including Tables 45
and 46, which summarize Medicare Part
B the potential alternative preventive
vaccine administration payment
amounts at the time of the publication
of this proposed rule. If the EUA
declaration continues to be in effect on
January 1, 2025, we propose that the
payment rates in Table 45 will apply. If
the EUA declaration is terminated
before January 1, 2025, we propose that
the payment rates in Table 45 will
apply.
For CY 2025, the proposed growth
rate of the 2017-based MEI is estimated
to be 3.6 percent, based on the IHS
Global, Inc. (IGI) first quarter 2024
forecast with historical data through
fourth quarter 2023. Therefore, Table 45
represents our CY 2024 payment rates
for the listed items, multiplied by 1.036.
We propose 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 2025 MEI percentage increase in
the CY 2025 PFS final rule; we would
apply that updated MEI percentage
increase to the rates found in the Tables
45 and 46 where applicable.
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549 https://www.cms.gov/medicare/payment/feefor-service-providers/part-b-drugs/average-drugsales-price/vaccine-pricing, under ‘‘COVID–19
Vaccines & Monoclonal Antibodies’’.
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TABLE 45: CY 2025 Part B Payments for Preventive Vaccine Administration
if the EUA Declaration for Drugs and Biologicals with Respect to COVID-19 Continues
into CY2025
Annual
Geographic
Category of Part B Product
Part B Payment Amount
Update 6
Adjustment
Administration
(Unadjusted)
MEI
GAF
Influenza,
$33.74
Pneumococcal,
Hepatitis B Vaccines 1•4
MEI
GAF
$44.99
COVID-19 Vaccine 2•4
MEI
GAF
$39.94
In-Home Additional Payment for
Part B Vaccine Administration
(M0201) 4
COVID-19 Monoclonal Antibodies
NIA
NIA
NIA
(for Treatment or Post-Exposure
Prophylaxis) 3,4,5
COVID-19 Monoclonal Antibodies
(for Pre-Exposure Prophvlaxis) 3 •4
NIA
Intravenous Infusion: Health Care
$450
GAF
Setting
1 HCPCS Codes G0008, G0009, G00lO.
2 CPT code 90480.
3 https://www.ems.gov/monoclonal.
4 Beneficiary coinsurance and deductible are not applicable.
5 As of the issuance of the CY 2025 PFS proposed rule, there are no monoclonal antibodies approved or authorized
for the treatment or for post-exposure prophylaxis of COVID- I 9
6 The proposed CY 2025 percentage increase of the 2017-based MEI is 3.6 percent based on IGl's first quarter of
2024 forecast with historical data through the 4th quarter of 2023.
TABLE 46: Part B Payments for Preventive Vaccine Administration Beginning January 1,
2025, if the EUA Declaration for Drugs and Biologicals with Respect to COVID 19 is
Terminated on or Before December 31, 2024
Category of Part B Product
Administration
Influenza,
Pneumococcal,
Hepatitis B 1•4
Part B Payment Amount
(Unadjusted)
$33.74
Annual
Update 6
MEI
Geographic
Adjustment
GAF
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$33.74
MEI
GAF
In-Home Additional Payment for
$39.94
MEI
GAF
Part B Vaccine Administration
(M0201) 4
COVID-19 Monoclonal Antibodies
(for Treatment or Post-Exposure
Medicare payment under the applicable payment system
Prophylaxis)3
COVID-19
TBD 5
NIA
GAF
Monoclonal Antibodies (for PreExposure Prophylaxis) 4•5
1 HCPCS Codes G0008, G0009, G00l0.
2 CPT code 90480
3 Payment is in accordance with the applicable payment system of the setting in which the product is administered.
Beneficiary coinsurance and deductible are applicable.
4 Beneficiary coinsurance and deductible are not applicable.
5 Please see section 111.H.1.e. of this proposed rule.
6 The proposed CY 2025 percentage increase of the 2017-based MEI is 3.6 percent, based on IGl's first quarter of
2024 forecast with historical data through the 4th quarter of 2023.
EP31JY24.074
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2. Revised Payment Policies for
Hepatitis B Vaccine Administration
In section III.M of this proposed rule,
CMS proposes to improve access and
utilization of hepatitis B vaccines by
expanding the list of individuals who
are at high or intermediate risk of
contracting hepatitis B at § 410.63.
Specifically, CMS proposes to expand
coverage of hepatitis B vaccinations by
revising § 410.63(a)(2), Intermediate
Risk Groups, by adding a new paragraph
(a)(2)(iv) to include individuals who
have not previously received a
completed hepatitis B vaccination series
and individuals whose previous
vaccination history is unknown. CMS
believes that this proposed coverage
change will help protect Medicare
beneficiaries from acquiring hepatitis B
infection, contribute to eliminating viral
hepatitis as a public health threat in the
United States, and is in the best interest
of the Medicare program and its
beneficiaries. Below, we discuss how
the proposal to expand coverage may
impact Part B payment policy for
hepatitis B vaccines and administration.
a. Background
Section 2323 of the Deficit Reduction
Act of 1984 (Pub. L. 98–369) amended
section 1861(s)(10) of the Act by adding
subparagraph (B) to provide Medicare
Part B coverage for the hepatitis B
vaccine and its administration for those
individuals who are at high or
intermediate risk of contracting
hepatitis B. The statute required the
Secretary to determine, by regulations,
criteria for identifying individuals who
are at high or intermediate risk of
contracting hepatitis B. In addition,
section 2323 of the Deficit Reduction
Act of 1984 added section 1833(k) of the
Act, which states that the Secretary may
provide, instead of the amount of
payment otherwise provided under Part
B for the hepatitis B vaccine and its
administration, for payment of such an
amount or amounts as reasonably
reflects the general cost of efficiently
providing such services.
In the June 4, 1990 Federal Register,
CMS issued a final rule to implement
section 2323 of the Deficit Reduction
Act of 1984 and the coverage provisions
were codified in regulation at
§ 410.63(a) (55 FR 22785). In the
preamble to 1990 rule, we stated that,
‘‘[f]or Medicare payment purposes, the
hepatitis B vaccine may be
administered—upon the order of a
doctor of medicine or osteopathy—by
qualified staff of home health agencies,
skilled nursing facilities, ESRD
facilities, hospital outpatient
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departments, HMO’s, persons
recognized under the ‘incident to
physician’s services’ provision of the
law (section 1861(s)(2)(A) of the Act), as
well as doctors of medicine and
osteopathy.’’ This policy is included in
the Medicare Claims Processing Manual,
Chapter 18, section 10.1.3.
In the CY 2013 PFS final rule (77 FR
69363), CMS amended the regulations at
§ 410.63(a) to include those diagnosed
with diabetes mellitus in the list of
groups at high risk of contracting
hepatitis B. In the November 6, 2020
COVID–19 IFC (85 FR 71145), in
preamble discussions surrounding the
implementation of coverage and
payment for the COVID–19 vaccine, we
mentioned the unique coverage and
payment requirements related the
hepatitis B vaccine under Part B. We
noted that, unlike pneumococcal,
influenza and COVID–19 vaccines,
hepatitis B vaccines require an
assessment of a patient’s risk of
contracting hepatitis B. Because,
hepatitis B vaccinations claims needed
a physician’s order, they could not be
roster billed by mass immunizers. More
information on the current physician’s
order policy for the administration of
hepatitis B vaccines in Part B can be
found in the Medicare Benefit Policy
Manual, Chapter 15, Section 50.4.4.2.
b. Revisions to Payment Policies for
Hepatitis B Vaccinations
As discussed above, section III.M of
this proposed rule revises § 410.63(a) to
provide coverage under Part B for
hepatitis B vaccines and their
administration for an expanded range of
Medicare enrollees. We explain that
Medicare coverage of hepatitis B
vaccination is outdated in light of recent
information about the risks of
contracting hepatitis B, and that current
research indicates that individuals who
remain unvaccinated against hepatitis B
are at intermediate risk of contracting
hepatitis B virus. Under the new
proposal, an assessment of an
individual’s vaccination status could
now be made without the clinical
expertise of a physician. Thus, if the
rule is finalized, we would remove our
policy in the manual that the
administration of a Part B hepatitis B
vaccine be preceded by a doctor’s order.
If the new definition at § 410.63(a) is
finalized as proposed, then a doctor’s
order would no longer be necessary for
the administration of a hepatitis B
vaccine under Part B.
If the physician’s order requirement is
eliminated, then we would also change
our procedures to allow mass
immunizers to use the roster billing
process to submit Medicare Part B
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claims for hepatitis B vaccines and their
administration.
Currently, instructions regarding
hepatitis B vaccine administration
under part B are contained in CMS
manual guidance. If changes to
§ 410.63(a) are finalized, then we would
make corresponding changes to
guidance in the Medicare Benefit Policy
Manual and Medicare Claims Processing
Manual. More information on roster
billing is available on the CMS web page
at https://www.cms.gov/roster-billing.
We note that the current payment
rates for HCPCS code G0010,
‘‘Administration of hepatitis b vaccine,’’
as finalized in the CY 2024 PFS final
rule, can be found on the CMS Vaccine
Pricing website under ‘‘Seasonal Flu
Vaccines’’.550 The payment rates for
G0010, with the annual update applied
for CY 2025, will be made available at
the time of publication of the CY 2025
PFS final rule. Tables 45 and 46 in
section III.H.1.f. of this proposed rule
provide the CY 2025 projected payment
rates for G0010. More information on
other policies related to the
administration of G0010 can be found in
the section preceding this one (section
III.H.1. of this proposed rule), and
proposed revisions to payment policies
for the administration of G0010 in RHCs
and FQHCs can be found in the section
immediately below (section III.H.2.c. of
this proposed rule).
c. Revisions to Payment Policies for
Hepatitis B Vaccinations in Rural Health
Clinics (RHC) and Federally Qualified
Health Centers (FQHC)
When section 2323 of the Deficit
Reduction Act of 1984 added section
1861(s)(10)(B) to the Act to add
Medicare Part B coverage for the
hepatitis B vaccine and its
administration, it limited that coverage
to certain settings. In RHCs and FQHCs,
the law specified at section
1833(a)(3)(A) of the Act that the
vaccines mentioned at section
1861(s)(10)(A) of the Act—namely,
pneumococcal and influenza (and later,
COVID–19) vaccines—are not included
in the all-inclusive payment rate for an
RHC or FQHC visit, but are reimbursed
as a separate payment. Pneumococcal,
influenza and COVID–19 vaccines and
their administration are paid at 100
percent of reasonable cost when
administered in an RHC or FQHC, in
accordance with section 1833(a)(1)(B) of
the Act. By contrast, hepatitis B
vaccines and the cost of administration
550 https://www.cms.gov/medicare/payment/feefor-service-providers/part-b-drugs/average-drugsales-price/vaccine-pricing, under ‘‘Seasonal Flu
Vaccines’’; see links to the relevant year under
‘‘Locality-Adjusted Payment Rates.’’
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are included in the capitated payment
for an RHC or FQHC visit. RHCs and
FQHC visits are generally paid at 80
percent of reasonable costs, and thus,
they are subject to coinsurance for
Medicare Part B enrollees. The Deficit
Reduction Act of 1984 also added
section 1833(k) to the Act, which states
that, for hepatitis B vaccines and their
administration as described at section
1861(s)(10)(B), the Secretary may
provide, instead of the amount of
payment otherwise dictated in statute,
for payment that ‘‘reasonably reflects
the general cost of efficiently providing
such services.’’
In CY 2011 PFS final rule (75 FR
73418), we addressed the issue of
coinsurance for hepatitis B vaccines and
their administration in FQHCs. The CY
2011 PFS final rule, which implemented
the expansion of preventive services in
Medicare as mandated by the ACA,
stated that effective January 1, 2011,
Part B coinsurance on hepatitis B
vaccinations was waived, as the vaccine
and its administration were deemed
‘‘preventive services’’ per section
1861(ddd)(3)(A) of the Act as crossreferenced to section 1861(ww)(2) of the
Act. (More information on preventive
services is provided immediately below
at section III.H.3. of this proposed rule).
The CY 2011 PFS final rule codified this
FQHC policy in regulation at
§ 405.2449. In the CY 2014 FQHC PPS
final rule (79 FR 25474), at
§ 405.2410(b), we codified regulations
regarding coinsurance in RHCs and
FQHCs which exempt from coinsurance
‘‘preventive services for which Medicare
pays 100 percent under § 410.152(l) of
this chapter’’, which explicitly includes
the hepatitis B vaccine. In the CY 2016
PFS final rule (80 FR 71088), we
clarified that these waivers of costsharing (both coinsurance and
deductible) for preventive services
applied to RHCs as well, and we
subsequently clarified in subregulatory
guidance that these waivers apply to the
administration of hepatitis B vaccines in
RHC and FQHCs.551 We note that FQHC
services are always exempt from the
Part B deductible, per section 1833(b)(4)
of the Act.
551 Updates were made to Chapter 13, section
220.1 of Medicare Benefit Policy Manual via
Change Request 9864, R2186CP, December 9, 2016,
‘‘Rural Health Clinic (RHC) and Federally Qualified
Health Center (FQHC) Updates’’: https://
www.cms.gov/Regulations-and-Guidance/
Guidance/Transmittals/Downloads/
R230BP.pdf.Updates were also made to Chapter 9,
section 60.3 of the Medicare Claims Processing
Manual via Change Request 9397, R3434CP,
December 31, 2015, ‘‘Reorganization of Chapter 9’’:
https://www.cms.gov/Regulations-and-Guidance/
Guidance/Transmittals/Downloads/R3434CP.pdf.
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Even though hepatitis B vaccines and
their administration are deemed
preventive services for which
coinsurance (and deductible in RHCs) is
waived, hepatitis B vaccines are still
currently paid differently than other
Part B vaccines in RHCs and FQHCs.
Due to the statutory differences
explained above, pneumococcal,
influenza and COVID–19 vaccines and
their administration are paid at 100 of
reasonable cost in RHCs and FQHCs—
that is, they are paid separately from the
FQHC PPS or the RHC All-Inclusive
Rate (AIR) methodology—while
hepatitis B vaccines and their
administration are paid as part of the
FQHCs PPS or the RHC AIR, which
means that they are paid through
changes to the facilities’ capitated rate.
In light of the proposal to expand
coverage for hepatitis B vaccination in
section III.M. of this proposed rule, we
propose to use the aforementioned
authority at section 1833(k) of the Act
to align payment for hepatitis B
vaccinations in RHCs and FQHCs with
the payment for pneumococcal,
influenza and COVID–19 vaccinations
in those settings. That is, we propose to
pay for hepatitis B vaccines and their
administration in RHCs and FQHCs at
100 percent of reasonable cost, separate
from the FQHCs PPS and the RHC AIR
methodology, for all populations
identified for coverage at § 410.63(a). As
is the case for pneumococcal, influenza
and COVID–19 vaccine administration,
under this proposal, a hepatitis B
vaccine administration would not be
considered an RHC or FQHC visit. If this
policy is finalized, then effective
January 1, 2025, RHCs and FQHCs
would bill for Part B hepatitis B
vaccines in the same manner as they
currently bill for pneumococcal,
influenza and COVID–19 vaccines, that
is, on their cost report. We note that we
proposed above, in section III.B.5 of this
proposed rule, to allow for billing and
payment of all Part B preventive
vaccines and their administration at the
time of service in RHCs and FQHCs,
with annual reconciliation on the
facilities’ cost reports. That policy, if
finalized as proposed, would be
effective for dates of service on or after
July 1, 2025. Both proposals together
support our goal of streamlining
payment for all Part B vaccines across
Part B settings of care. We believe that
streamlining Part B vaccine and vaccine
administration payments among care
settings aligns with the stated goals of
section 1833(k) of the Act, since those
payment policy changes will allow for
increased efficiency in Part B claims
processing on both the part of the RHCs
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and FQHCs and on the part of CMS. We
also believe that the increased efficiency
will promote vaccine access, and thus
health equity in general, in RHCs and
FQHCs that already serve vulnerable
populations.
To implement this proposal regarding
payment for hepatitis B vaccines and
their administration in RHCs and
FQHCs, we also propose to amend the
regulations at § 405.2466(b)(1)(iv), to
add hepatitis B vaccines to the list of
vaccines covered in RHCs and FQHCs at
100 percent of reasonable cost. Upon the
publication of the CY 2025 PFS final
rule, if revisions to § 405.2466(b)(1)(iv)
are finalized as proposed, we would
make corresponding changes to
guidance in the Medicare Benefit Policy
Manual, Chapter 13 and Medicare
Claims Processing Manual, Chapter 9. If
finalized, we also plan to facilitate the
necessary operational systems updates
needed to implement these changes.
d. Regulations Concerning Hepatitis B
Vaccines and their Administration
Listed below are several Medicare
Part B regulations that mention the
hepatitis B vaccine and refer to
§ 410.63(a) for a definition of hepatitis B
vaccine coverage. Since we are
proposing to revise § 410.63(a) in
section III.M. of this proposed rule, we
do not believe additional regulation text
changes are needed to conform to the
coverage proposal, as the update to the
definition at § 410.63(a) will apply to
the use of the definition in these
regulations:
• Section 410.10(p).
• Section 410.57(d).
• Section 411.15(e)(3) and (k)(5).
• Section 414.707(a)(2)(iii).
• Section 414.904(e)(1).
In addition, we note that there are no
conforming regulation text changes
needed to the payment regulations at
§ 410.152, paragraphs (h) and (l)(1), to
conform to the coverage proposal.
3. Payment for Drugs Covered as
Additional Preventive Services
(§ 410.152)
a. Statutory Background
Section 101 of the Medicare
Improvements for Patients and
Providers Act (MIPPA) of 2008 (Pub. L.
110–275) added section 1861(ddd)(1)
and (2) of the Act to effectuate
‘‘improvements to coverage of
preventive services’’ in the Medicare
program. Under section 1861(ddd)(1) of
the Act, Medicare Part B covers
‘‘additional preventive services’’ that
identify medical conditions or risk
factors and that the Secretary
determines are reasonable and necessary
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for: (A) the prevention or early detection
of an illness or disability; (B) that are
recommended with a grade of A or B by
the United States Preventive Services
Task Force; and (C) that are appropriate
for individuals entitled to benefits
under Part A or enrolled under Part B.
Section 1861(ddd)(2) of the Act states
that, in making determinations under
section 1861(ddd)(1) of the Act, the
Secretary should use the process for
making National Coverage
Determinations (NCD) in the Medicare
program.
Section 101 of MIPPA also added
section 1833(a)(1)(W) of the Act, which
provides requirements for payment of
additional preventive services. Section
1833(a)(1)(W)(i) establishes
requirements for payment of additional
preventive services that are clinical
diagnostic laboratory tests, and section
1833(a)(1)(W)(ii) establishes
requirements for payment of all other
services. Section 1833(a)(1)(W)(ii) (as
amended by section 4104 of the
Affordable Care Act (Pub. L. 111–148)
requires that the amount paid for the
provision of all other additional
preventive services is 100 percent of the
lesser of the actual charge for the
service, or the amount determined
under a fee schedule established by the
Secretary for purposes of this
subparagraph.
We note that ‘‘additional preventive
services’’ are a subset of ‘‘preventive
services’’ under Medicare Part B, per
section 1861(ddd)(3) and
1861(ww)(2)(O) of the Act, respectively.
Section 1833(b)(1) of the Act states that
the annual Part B deductible does not
apply to preventive services, and
section 1833(a)(1)(Y) of the Act waives
coinsurance for preventive services that
are recommended with a grade of A or
B by the USPSTF for any indication or
population. Based on all the above
statutory authorities, there is no costsharing under Part B for additional
preventive services for Medicare
enrollees, that is, there is no applicable
beneficiary coinsurance or deductible
for these services.
The term ‘‘preventive services’’ is
defined at § 410.2, and coverage for
‘‘additional preventive services’’ is
delineated at § 410.64. At § 410.152(l),
we list the Part B preventive services
that are paid at 100 percent of the
Medicare payment amount, that is, for
which zero coinsurance is charged.
There, at § 410.152(l)(11), we include
‘‘additional preventive services
identified for coverage through the
national coverage determination (NCD)
process’’. At § 410.160(b), we list the
Part B services that are not subject to the
Part B annual deductible and do not
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count toward meeting that deductible,
and ‘‘additional preventive services
identified for coverage through the
national coverage determination (NCD)
process’’ is included there at
§ 410.160(b)(13).
The payment authority under section
1833(a)(1)(W)(ii) of the Act has not been
utilized to date because CMS has not yet
covered any additional preventive
service that would require use of that
payment authority. While CMS
currently covers certain screenings and
therapies as additional preventive
services under the section 1861(ddd) of
the Act, those screenings and therapies
are currently paid under the existing
PFS fee schedule for physician services.
Furthermore, the Medicare Diabetes
Prevention Program, described at
section III.E of this proposed rule, uses
the section 1833(a)(1)(W)(ii) authority to
waive the coinsurance and deductible as
described above, but its payment policy
is based on separate authorities under
the model.
Specifically, we note that CMS has
not yet covered or paid for any drugs or
biologicals (hereinafter, referred to as
drugs) under the benefit category of
additional preventive services. This was
highlighted when CMS released a
Proposed NCD for Pre-Exposure
Prophylaxis (PrEP) for Human
Immunodeficiency Virus (HIV) Infection
Prevention on July 12, 2023. This
proposed NCD announced CMS’
intention to cover and pay for those
drugs under section 1861(ddd) of the
Act’s additional preventive services
authority, and a decision on the NCD is
forthcoming. We note that CMS covers
and pays for Part B vaccines, which are
also considered preventive services
under sections 1861(ddd)(3) and
1861(ww)(2)(A) of the Act, but they
have unique payment rates specified in
statute at section 1842(o)(1)(A)(iv) of the
Act (for more information, see above at
section III.H.1.a. of this proposed rule).
b. Proposed Fee Schedule for Drugs
Covered as Additional Preventive
Services (DCAPS)
As discussed above, the authority at
section 1833(a)(1)(W)(ii) of the Act
provides for payment for additional
preventive services, including drugs.
This authority differs from the authority
used to pay drugs that are separately
paid as drugs and biologicals under
other Part B payment authorities.
Specifically, payment for most drugs
separately payable under Part B is
authorized at section 1833(a)(1)(S) of the
Act and outlined at section
1842(o)(1)(C) of the Act, and those
payments are generally made according
to the Average Sales Price (ASP)
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61931
methodology that is described at section
1847A of the Act. In addition, because
drugs covered as additional preventive
services (hereinafter, DCAPS; we will
use the term ‘‘DCAPS drugs’’ for the
ease of the reader) are not described in
section 1842(o)(1)(C) of the Act,
provisions under section 1847A of the
Act would not apply, including
requirements for manufacturers to
report ASP to CMS on a quarterly basis
(see sections 1847A(f) and
1927(b)(3)(A)(iii) of the Act). When
manufacturers are not required to report
the manufacturer’s ASP for a drug, they
may do so voluntarily, but the
availability of voluntarily reported ASP
data cannot be guaranteed, and the data
may not reflect all available NDCs for
the drug. However, we emphasize that
DCAPS drugs that are also covered
under Part B for non-preventive
indications (that is, are also used for
diagnosis or treatment) would be subject
to ASP reporting requirements.
Above, we mentioned that section
1833(a)(1)(W)(ii) of the Act requires that
the amount paid for the provision of
additional preventive services is 100
percent of the lesser of the actual charge
for the service, or the amount
determined under a fee schedule
established by the Secretary for
purposes of this subparagraph. For
purposes of this policy, we refer to the
amount determined under the fee
schedule as the payment limit, which
we discuss in detail below.
We are proposing a fee schedule for
DCAPS drugs that uses existing Part B
drug pricing mechanisms, because we
believe that it is preferable to set all
drug payment limits under Part B,
including those for DCAPS, as
consistently as possible. Accordingly,
we propose that the payment limit for
a DCAPS drug be determined using the
methodology described in section
1847A of the Act (also referred to as
ASP methodology), or, if ASP data is not
available for a particular drug, to use an
alternative pricing mechanism, as
described below. We propose to update
the fee schedule quarterly, on the same
schedule as the ASP pricing file, which
is updated each calendar quarter.
(1) Payment Limit Based on Section
1847A of the Act
To determine the payment limit for
the applicable billing and payment code
for a DCAPS drug under the fee
schedule, we propose to apply ASP
methodology described in section
1847A of the Act when ASP data is
available for the drug. We believe the
use of ASP data would be preferable for
determining the payment limit for
DCAPS drug billing and payment codes
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for two reasons. First, this approach
would determine the payment limit for
these drugs in the same way as the
payment limit is usually determined for
other drugs that are separately payable
under Part B, when possible. This
would include the application of
payment limit calculations for multiple
source drugs, single source drugs and
biologicals, and biosimilar biological
products, as is done for products under
section 1847A of the Act, for each
applicable billing and payment code.
Second, because section 1847A(c)(3) of
the Act requires that calculation of the
manufacturer’s ASP for an NDC must
include volume discounts, prompt pay
discounts, cash discounts, free goods
that are contingent on any purchase
requirement, chargebacks, and rebates
(other than rebates under the Medicaid
drug rebate program, discounts under
the 340B Program, and rebates under the
Part B and Part D Medicare inflation
rebate program), this would set a
payment limit that would likely better
reflect acquisition cost of the drug than
list prices in available compendia (such
as Wholesale Acquisition Cost (WAC)).
We propose that CMS would
determine the payment limit for DCAPS
drugs as the amount that would result
from application of ASP methodology in
section 1847A of the Act only if ASP
data for the drug is available for a given
quarter (that is, positive manufacturer’s
ASP data is reported by the drug
manufacturer, as explained in section
III.A.2 of this proposed rule). We
propose that if ASP data is available for
a DCAPS drug, the payment limit would
be the amount described in section
1847A(b) of the Act, which is usually
106 percent of ASP.
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(2) Payment Limit Based on National
Average Drug Acquisition Cost
(NADAC) Pricing
If ASP data for a DCAPS drug (as
described in the previous section) is not
available (as defined in the prior
paragraph), we propose to determine the
payment limit for the applicable billing
and payment code using the most
recently published amount for the drug
in Medicaid’s National Average Drug
Acquisition Cost (NADAC) survey (OMB
control number 0938–1041).552 When
using NADAC data, we propose to
determine the payment limit per billing
unit, which would be an average of
NADAC prices for all NDCs for the drug.
If a drug is available in generic and
brand formulations, we propose all
NDCs will be averaged together to
determine the payment limit.
Since the timing of ASP reporting and
publishing has a two-quarter lag (for
example, payment limits calculated
using data reported from the first
quarter of sales become effective two
quarters later), we propose that ‘‘most
recently published’’ for purposes of this
policy means the most recently updated
NADAC survey available 30 days after
the close of the quarter for which ASP
data would have been reported if it were
available.553 For example, in the
calculation of the payment limit for
dates of service in the third calendar
quarter, if NADAC is used to determine
the payment limit, CMS would use the
most recent NADAC survey update
available on the 30th day after the close
of the first calendar quarter to determine
the payment limit for the third quarter.
The NADAC survey provides a
national drug pricing benchmark for
certain drugs that is adequately
comprehensive to serve as the first
alternative pricing source in the case
that ASP data is not available. CMS
conducts surveys of retail community
pharmacy prices to develop the NADAC
pricing benchmark in the annual
NADAC pricing file. The pricing
benchmark is reflective of the prices
paid by retail community pharmacies to
acquire prescription and over-thecounter covered outpatient drugs.
NADAC data is publicly available and it
can be accessed at https://
data.medicaid.gov/nadac.
In the CY 2020 PFS final rule (84 FR
62655), we similarly finalized the use of
NADAC pricing as a pricing alternative
for oral drugs under the Part B Opioid
Treatment Program (OTP) benefit when
ASP data is not available. There, we
stated that ‘‘[s]urvey data on invoice
prices provide the closest pricing metric
to ASP that we are aware of.’’ Because
the previous statement continues to be
true, it is an appropriate alternative in
the pricing framework for DCAPS drugs
when ASP data is not available.
(3) Payment Limit Based on the Federal
Supply Schedule (FSS)
Since NADAC pricing is only
available for drugs typically dispensed
through retail community pharmacies,
there could be circumstances in which
ASP and NADAC data are not available
for DCAPS drugs. Therefore, if both ASP
and NADAC pricing data are not
available for a DCAPS drug, we propose
to use the most recently published and
listed prices for pharmaceutical
products in the Federal Supply
Schedule (FSS) to calculate the payment
552 https://www.medicaid.gov/medicaid/
prescription-drugs/retail-price-survey/.
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553 42
CFR 414.804(a)(5).
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limit for the applicable billing and
payment code. In the same manner as
discussed in the previous section, we
propose that ‘‘most recently published’’
for purposes of this policy means the
most recently updated FSS survey
available 30 days after the close of the
quarter for which ASP data would have
been reported if it were available.554 For
example, in the calculation of the
payment limit for dates of service in the
third calendar quarter, if FSS is used to
determine the payment limit, CMS
would use the most recent FSS update
available on the 30th day after the close
of the first calendar quarter to determine
the payment limit for the third quarter.
When using the FSS, we would
calculate the average price per billing
unit (as described in the billing and
payment code for the drug) for all NDCs
listed for a drug.
Drug pricing information from the
Veterans Affairs’ (VA’s) FSS
pharmaceutical pricing database is
publicly available at the NDC level and
published at https://www.va.gov/opal/
nac/fss/pharmPrices.asp. We propose to
use FSS data when ASP and NADAC
data are not available because FSS data
is one of the few existing options for
drug pricing that includes a wide
variety of drug formulations, including
both self-administered drugs typically
dispensed through retail community
pharmacies and drugs administered
incident to a physician’s service. We
believe that using FSS data to calculate
the payment limit for DCAPS drugs is
preferable to instructing MACs to
determine DCAPS drug payment limits
according to invoice (as discussed
below), because invoice-based pricing
requires MACs to manually process
claims and is therefore burdensome to
the MACs.
(4) Invoice Pricing
Finally, if ASP, NADAC, and FSS
pricing are not available for a particular
drug covered as an additional
preventive service, then MACs will
determine the payment for that drug
according to invoice. Since one of the
three above pricing mechanisms should
be available in nearly all cases, we
expect that invoice pricing would be
necessary only in rare situations.
Specifically, we believe that invoice
pricing would likely only be necessary
for new drugs before pricing data is
available.
To summarize, we propose to
establish a fee schedule using the
following pricing mechanisms to
determine the payment limit for DCAPS
554 42
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drugs under Part B, which would be
updated quarterly:
(1) If ASP data is available for the
DCAPS drug, the payment limit would
be determined based on the
methodology under section 1847A(b) of
the Act (usually 106 percent of ASP);
(2) If ASP data is not available, the
payment limit would be calculated
using NADAC prices for the drug;
(3) If ASP data and NADAC prices are
not available, the payment limit would
be calculated using the FSS prices for
the drug; and
(4) If ASP data, NADAC prices, and
FSS prices are not available, payment
limit would be the invoice price
determined by the MAC.
We are proposing to amend § 410.152
by adding paragraph (o) to establish the
fee schedule and the pricing
methodologies used to determine the
payment limit for DCAPS drugs under
Part B. In addition, to highlight that
coinsurance does not apply to DCAPS
drugs, we propose to publish the
payment limits for DCAPS drugs along
with other separately payable Part B
drugs on the ASP pricing file.
We invite public comment on the
proposed fee schedule for drugs paid as
additional preventive services.
c. Payment for Supplying and
Administration of Drugs Under the
Additional Preventive Services Benefit
As explained above, DCAPS drugs are
subject to payment under section
1833(a)(1)(W)(ii) of the Act. Because the
fee schedule authorized under such
section has not yet been established,
and since DCAPS drugs are not covered
by Part B under the same authority as
other separately payable Part B drugs
that would provide for administration or
supplying fees, there is no existing
policy regarding payment for the
administration of DCAPS drugs or the
supplying of DCAPS drugs by suppliers
and providers. In a similar manner to
the DCAPS drug pricing mechanisms
described above, we propose
administration and supplying fees for
DCAPS drugs that mirror existing
policies under the PFS and Part B drug
payment. We anticipate that an NCD
that adds drugs to the additional
preventive services benefit would
include coverage for the supplying or
administration of the drug, as
appropriate, and those fees would
therefore be considered payment for
additional preventive services as well.
Therefore, we are proposing payment
limits for the supply and administration
of DCAPS drugs to be included on the
DCAPS fee schedule. As stated above,
section 1833(a)(1)(W)(ii) of the Act
requires that the amount paid for the
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provision of additional preventive
services is 100 percent of the lesser of
the actual charge for the service, or the
amount determined under a fee
schedule established by the Secretary
for purposes of this subparagraph. That
is, the amount paid for the
administration or supplying of the
DCAPS drug will be the lesser of either
the actual charge for the service or the
payment limit.
For drugs that are supplied by a
pharmacy, we propose that the fee
schedule include a payment limit for a
supplying fee that is similar to the
supplying fee for other Part B-covered
drugs dispensed from a pharmacy, to
allow for consistency among similar
payments in Part B. These other groups
of drugs covered under Part B include
immunosuppressives, oral anti-cancer,
and oral anti-emetic drugs, and
supplying fees for these drugs are
described at 42 CFR part 414, subpart L
(§§ 414.1000 and 414.1001). Generally,
Medicare pays $24 for the first
prescription of one of these drugs
supplied by a pharmacy in a 30-day
period, and pays $16 for each
subsequent prescription, after the first
one, supplied in that 30-day period.555
We propose similar payment limits for
supplying fees for DCAPS drugs.
Specifically, we propose that CMS will
establish payment limit of $24 to a
pharmacy for the first DCAPS
prescription that the pharmacy supplies
to a beneficiary in a 30-day period, and
a payment limit of $16 to a pharmacy
for all subsequent DCAPS prescriptions
that the pharmacy supplies to a
beneficiary in that 30-day period. We
are proposing that the same fees would
apply regardless of the number of days’
supply that is dispensed.
As discussed in section III.A.4.c of
this proposed rule, we intend to further
study the supplying fees for certain
drugs paid under Part B (for example,
immunosuppressive drugs) and are not
proposing to make any changes to the
supplying fee amounts at this time
(meaning the current 30-day supplying
fees would apply to any amount of days’
supply). The dispensing and supplying
fees under Part B (§ 414.1001) have been
shown to be higher than dispensing fees
paid in the commercial market.556 So,
until additional study is done regarding
input costs for dispensing drugs billed
555 https://www.cms.gov/regulations-and-
guidance/guidance/manuals/downloads/
clm104c17.pdf.
556 https://www.pcmanet.org/rx-research-corner/
mandating-pharmacy-reimbursement-increasespending/08/31/2021/#::text=
The%20average%20dispensing%20
fee%20in,the%20state’s%20Medicaid
%20FFS%20rate.
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to Medicare Part B and subsequent
notice-and-comment rulemaking can be
done, if appropriate, in response to such
information, we aim to continue the
current fee schedule for such Part B
drugs regardless of the days’ supply
dispensed. Therefore, we propose to use
the same approach for payment limits
that are paid to pharmacies that supply
DCAPS prescriptions.
For drugs that are administered by a
physician or a non-physician
practitioner, we propose that the fee
schedule include a payment limit for
such administration that aligns with the
administration fee for other drugs
provided as incident to physician
services, as paid according to the PFS.
To operationalize this, we propose that
CMS determine the payment limit for
administration of a DCAPS drug
provided incident to a physician service
via a crosswalk to an existing,
corresponding drug administration code
under the PFS. Exact details on coding
and corresponding crosswalks would be
included on the published fee schedule
once DCAPS drugs are finalized for
coverage via the NCD process. The fee
schedule would be published quarterly
on the CMS website and implemented
in the Medicare claims processing
systems.
No cost sharing would apply for the
administration or supplying of DCAPS
drugs, because we are proposing that
such administration or supplying would
be considered an additional preventive
service, and as explained above, there is
no cost-sharing for any additional
preventive services under section
1833(a)(1)(W) of the Act. We propose to
codify these policies at the newly added
§ 410.152(o).
We note that with regard to the July
12, 2023 Proposed NCD for PreExposure Prophylaxis (PrEP) for Human
Immunodeficiency Virus (HIV) Infection
Prevention, in section II.E.4.b. of this
proposed rule, in item 37, we propose
national rates for HCPCS code G0012
(Injection of pre-exposure prophylaxis
(PrEP) drug for HIV prevention, under
skin or into muscle) that are
crosswalked from CPT code 96372
(Therapeutic, prophylactic, or
diagnostic injection (specify substance
or drug); subcutaneous or
intramuscular). Please see that section
for more information.
d. Payment for Drugs Covered as
Additional Preventive Services in RHCs
and FQHCs
Above, we mentioned that section
4104 of the ACA amended payment for
additional preventive services, to
increase payment to the lesser of 100
percent of charges, or the amount
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determined under a fee schedule
established by the Secretary, per Section
1833(a)(1)(W)(ii). This change waived
coinsurance for additional preventive
services. Section 4104 of the ACA also
removed several other barriers to access
to preventive services in Medicare.
Specifically, section 4104 of the ACA
amended section 1833 of the Act to
waive the deductible for preventive
services at section 1833(b)(1) of the Act,
and to waive coinsurance for preventive
services that are recommended with a
grade of A or B by the USPSTF for any
indication or population by adding
section 1833(a)(1)(Y) of the Act. We also
mentioned above that ‘‘additional
preventive services’’ are a subset of
‘‘preventive services’’ under Medicare
Part B, per section 1861(ddd)(3) and
1861(ww)(2)(O) of the Act, respectively.
In the CY 2011 PFS final rule, we
interpreted the above waivers of costsharing for preventive services to apply
to FQHCs (75 FR 73417); we note that
FQHC services were already exempt
from the Part B deductible, per section
1833(b)(4) of the Act. The CY 2011 PFS
final rule codified this FQHC policy in
regulation at § 405.2449 (75 FR 73613),
and in sub-regulatory guidance, we
clarified that these waivers of costsharing for preventive services applied
to RHCs as well.557 In the CY 2014
FQHC PPS final rule (79 FR 25474), at
§ 405.2410(b), we codified regulations
regarding coinsurance in RHCs and
FQHCs, ‘‘[E]xcept for preventive
services for which Medicare pays 100
percent under § 410.152(l) of this
chapter.’’ In the CY 2016 PFS final rule
(80 FR 71088), we clarified explicitly
that these waivers of cost-sharing (that
is, both coinsurance and deductible) for
preventive services applied to RHCs.
In the previous sections of III.H.3. of
this proposed rule, we discussed drugs
covered as additional preventive
services (henceforth ‘‘DCAPS drugs,’’ for
the ease of the reader). In this section,
we are clarifying that drugs covered as
additional preventive services, and any
accompanying administration and
supplying fees, are not subject to costsharing in RHCs and FQHCs. Since
DCAPS drugs and the services to
administer and supply them are all
considered additional preventive
services, as explained in the previous
section, they are paid at 100 percent of
the Medicare payment amount in RHCs
and FQHCs per §§ 405.2410 and
557 Change Request 7208, R2186CP, 03/28/2011
Waiver of Coinsurance and Deductible for
Preventive Services in Rural Health Clinics (RHCs),
Section 4104 of Affordable Care Act (ACA): https://
www.cms.gov/regulations-and-guidance/guidance/
transmittals/downloads/r2186cp.pdf.
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410.152(l) and they are paid on a claimby-claim basis.
In addition, we are proposing that
DCAPS drugs, when administered and
supplied in an RHC or FQHC, as well as
any administration and supply fee for
those drugs, would be paid according to
the fee schedule payment limits
described above at section III.H.3.b. of
this proposed rule. Since regulations at
§ 405.2460 allow the payment
limitations set out in Part 410 to apply
to payment for services provided by
RHCs and FQHCs, we believe it is
consistent with our current RHC and
FQHC payment policies to apply the
proposed DCAPS fee schedule payment
limits, as discussed above, to those same
DCAPS drugs when furnished in an
RHC or FQHC. Those payment limits are
described earlier in section III.H.3.b.,
and if finalized as proposed, they would
be codified at § 410.152(o)(1). We
propose to codify this RHC/FQHC
DCAPS policy in regulation as well, at
a new § 405.2464(h).
We welcome comments on these
proposals.
I. Medicare Prescription Drug Inflation
Rebate Program
1. Background
a. Overview of the Medicare
Prescription Drug Inflation Rebate
Program
The Inflation Reduction Act of 2022
(IRA) (Pub. L. 117–169, enacted August
16, 2022) established new requirements
under which drug 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 a calendar quarter
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 a 12-month period,
starting with the 12-month period that
began October 1, 2022.
Section 11101 of the IRA amended
section 1847A of the Act by adding a
new subsection (i), which establishes a
requirement for drug manufacturers to
pay rebates into the Medicare
Prescription Drug Account in the
Federal Supplementary Medical
Insurance Trust Fund for Part B
rebatable drugs if the specified amount
exceeds the inflation-adjusted payment
amount, which is calculated as set forth
in section 1847A(i)(3)(C) of the Act. The
IRA also provides for an adjustment to
the beneficiary coinsurance amount in
cases where the price of a Part B
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rebatable drug increases faster than the
rate of inflation such that the
beneficiary coinsurance is calculated
based on the lower inflation-adjusted
payment amount instead of the
applicable payment amount. Section
1847A(i)(2) of the Act defines a ‘‘Part B
rebatable drug,’’ in part, as a single
source drug or biological product (as
defined in section 1847A(c)(6)(D) of the
Act), including a biosimilar biological
product (as defined in section
1847A(c)(6)(H) of the Act), but
excluding a qualifying biosimilar
biological product (as defined in section
1847A(b)(8)(B)(iii) of the Act) for which
payment is made under Part B.
Section 11102 of the IRA added
section 1860D–14B of the Act, which
requires drug manufacturers to pay
rebates into the Medicare Prescription
Drug Account in the Federal
Supplementary Medical Insurance Trust
Fund for each 12-month applicable
period, starting with the applicable
period beginning on October 1, 2022, for
Part D rebatable drugs if the annual
manufacturer price (AnMP) of such drug
exceeds the inflation-adjusted payment
amount. Section 1860D–14B(g)(1)(A) of
the Act defines a ‘‘Part D rebatable
drug,’’ in part, as a drug or biological
described at section 1860D–14B(g)(1)(C)
of the Act that is a ‘‘covered Part D
drug’’ as that term is defined in section
1860D–2(e) of the Act. The definition of
a Part D rebatable drug includes drugs
approved under a new drug application
under section 505(c) of the Federal
Food, Drug, and Cosmetic (FD&C) Act
(that is, brand name drugs), generic
drugs approved under section 505(j) of
the FD&C Act that meet certain statutory
criteria (that is, sole source generic
drugs), and biologicals licensed under
section 351 of the Public Health Service
Act (PHS), including biosimilars.
Under the IRA, certain statutory
requirements vary for implementation of
the Medicare Part B Drug Inflation
Rebate Program and the Medicare Part D
Drug Inflation Rebate Program. For
example, section 1847A(i) of the Act
requires CMS to calculate Part B drug
inflation rebates for a calendar quarter,
whereas section 1860D–14B of the Act
requires CMS to calculate Part D drug
inflation rebates for each 12-month
applicable period. With respect to
invoicing manufacturers for the rebate
amount owed, under section 1847A(i)(1)
of the Act, CMS must report rebate
amounts to each manufacturer of a Part
B rebatable drug no later than 6 months
after the end of each calendar quarter,
except that for calendar quarters
beginning in 2023 and 2024, CMS has
until September 30, 2025, to invoice
manufacturer for rebates. In contrast,
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under section 1860D–14B(a) of the Act,
CMS must report rebate amounts to each
manufacturer of a Part D rebatable drug
no later than 9 months after the end of
each applicable period, except that for
the first two applicable periods (that is,
October 1, 2022, to September 30, 2023,
and October 1, 2023, to September 30,
2024), CMS has until December 31,
2025, to invoice manufacturers for Part
D inflation rebates. Additionally, there
are statutory differences in the inputs
used to calculate the rebate amounts for
Part B and Part D. As a result, CMS is
proposing to use different
methodologies to calculate inflation
rebates for Part B rebatable drugs and
Part D rebatable drugs. However, CMS
has attempted to align policies across
the Medicare Part B Drug Inflation
Rebate Program and Medicare Part D
Drug Inflation Rebate Program to the
extent possible.
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b. Summary of Proposed Policies for the
Medicare Prescription Drug Inflation
Rebate Program
CMS is proposing to codify policies
established in the revised guidance for
the Medicare Part B Drug Inflation
Rebate Program and the Medicare Part D
Drug Inflation Rebate Program 558
(collectively referred to as the
‘‘Medicare Prescription Drug Inflation
Rebate Program’’) in regulatory text.
Specifically, CMS is proposing to codify
with limited modification policies set
forth in guidance for the Medicare
Prescription Drug Inflation Rebate
Program by adding new parts 427 and
428 to title 42, chapter IV of the Code
of Federal Regulations for Part B and
Part D, respectively, and welcomes
comments on these proposals.
In addition, CMS is proposing new
policies for the Medicare Part B Drug
Inflation Rebate Program as follows:
• Proposed § 427.201(b) provides that
CMS would compare the payment
amount in the quarterly pricing files
published by CMS to the inflationadjusted payment amount for a given
quarter when determining whether the
558 Medicare Part B Drug Inflation Rebate Revised
Guidance: https://www.cms.gov/files/document/
medicare-part-b-inflation-rebate-program-revisedguidance.pdf; Medicare Part D Drug Inflation
Rebate Revised Guidance: https://www.cms.gov/
files/document/medicare-part-d-inflation-rebateprogram-revised-guidance.pdf (collectively referred
to as the ‘‘revised guidance’’). These revised
guidance documents, published December 14, 2023,
implemented policies relating to the Medicare
Prescription Drug Inflation Rebate Program for
2022, 2023, and 2024. CMS also published guidance
on the use of the 340B modifier to report separately
payable Part B drugs and biologicals acquired under
the 340B program (Revised Part B Inflation Rebate
Guidance: Use of the 340B Modifier, https://
www.cms.gov/files/document/revised-part-binflation-rebate-340b-modifier-guidance.pdf).
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criteria for a coinsurance adjustment are
met.
• Proposed § 427.302(c)(3) provides
that for a Part B rebatable drug first
approved or licensed by the FDA on or
before December 1, 2020 but with a first
marketed date after December 1, 2020,
the payment amount benchmark quarter
for such drug is the third full calendar
quarter after the drug’s first marketed
date. Proposed § 427.302(c)(4) further
provides that for a Part B rebatable drug
that was billed under a NOC code
during the calendar quarter beginning
July 1, 2021, or the third full calendar
quarter after such drug’s first marketed
date, whichever is later, the payment
amount benchmark quarter is the third
full calendar quarter after the drug is
assigned a billing and payment code
other than a NOC code.
• Proposed § 427.303(b)(1)(i) provides
that CMS would remove 340B units for
professional claims with dates of service
during 2024 (in addition to 2023)
submitted by Medicare suppliers that
are listed by the Health Resources and
Services Administration (HRSA) 340B
Office of Pharmacy Affairs Information
System as participating in the 340B
Program, by using National Provider
Identifiers and/or Medicare Provider
numbers to identify these suppliers and
the claims submitted with such
identifiers.
• Proposed § 427.303(b)(5) provides
that CMS would remove units of
refundable single-dose container or
single-use package drugs subject to
discarded drug refunds, from the
calculation of rebate amounts, generally
in the reconciliation process.
• Proposed § 427.501 describes CMS’
method and process for reconciliation of
a rebate amount for a Part B rebatable
drug, including the circumstances that
may trigger such a reconciliation.
• Proposed § 427.600 establishes a
civil money penalty process in
accordance with section 1847A(i)(7) of
the Act to address when a manufacturer
of a Part B rebatable drug fails to pay the
rebate amount in full by the payment
deadline for such drug for such
applicable calendar quarter.
• Proposed § 427.10 provides that,
were any provision of part 427 to be
held invalid or unenforceable by its
terms, or as applied to any person or
circumstance, such provisions would be
severable from part 427 and the
invalidity or unenforceability would not
affect the remainder thereof or any other
part of this subchapter or the
application of such provision to other
persons not similarly situated or to
other, dissimilar circumstances.
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61935
CMS also is proposing new policies
for the Medicare Part D Drug Inflation
Rebate Program as follows:
• Proposed § 428.202(c)(3) provides
that if a Part D rebatable drug first
approved or licensed by the FDA on or
before October 1, 2021, does not have
AMP data reported under section
1927(b)(3) of the Act for any quarters
during the period beginning on January
1, 2021 and ending on September 30,
2021, CMS would identify the payment
amount benchmark period as the first
calendar year, which would be no
earlier than calendar year 2021, in
which such drug has at least 1 quarter
of AMP reported. Proposed
§ 428.202(c)(4) further provides that for
a Part D rebatable drug first approved or
licensed after October 1, 2021 (that is,
a subsequently approved drug), for
which there are no quarters during the
first calendar year beginning after the
drug’s first marketed date for which
AMP has been reported under section
1927(b)(3), the payment amount
benchmark period would be the first
calendar year in which such drug has at
least 1 quarter of AMP reported. CMS is
also soliciting comments on alternative
policies to address certain instances in
which AMP are not reported for certain
NDC–9s of a Part D rebatable drug.
• Proposed § 428.203(b)(2) provides
that, for claims with dates of service on
or after January 1, 2026, and with
respect to an applicable period, CMS
would exclude from the total number of
units used to calculate the total rebate
amount for a Part D rebatable drug those
units of the Part D rebatable drug for
which a manufacturer provided a
discount under the 340B Program. To
determine the total number of such
units for which a manufacturer
provided a discount under the 340B
Program, CMS would use data reflecting
the total number of units of a Part D
rebatable drug for which a discount was
provided under the 340B Program and
that were dispensed during the
applicable period. CMS may apply
adjustment(s) to these data as needed.
CMS is also soliciting comments on
alternative policies for collecting and
using 340B data to calculate rebate
amounts for Part D rebatable drugs.
• Proposed § 428.401 describes CMS’
method and process for reconciliation of
a rebate amount for a Part D rebatable
drug, including the circumstances that
may trigger such a reconciliation.
• Proposed § 428.500 establishes a
civil money penalty process in
accordance with section 1860D–14B(e)
of the Act to address when a
manufacturer of a Part D rebatable drug
fails to pay the rebate amount in full by
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the payment deadline for such drug for
such applicable period.
• Proposed § 428.10 provides that,
were any provision of part 428 to be
held invalid or unenforceable by its
terms, or as applied to any person or
circumstance, such provisions would be
severable from this part and the
invalidity or unenforceability would not
affect the remainder thereof or any other
part of this subchapter or the
application of such provision to other
persons not similarly situated or to
other, dissimilar circumstances.
Unless otherwise specified, CMS
proposes that the provisions herein
would apply, with respect to Part B
rebatable drugs, for all calendar quarters
beginning with January 1, 2023, and
with respect to Part D rebatable drugs,
for all applicable periods beginning
with October 1, 2022. The IRA directs
the Secretary to calculate rebate
amounts for Part B rebatable drugs
beginning on January 1, 2023, and Part
D rebatable drugs beginning on October
1, 2022, using pricing data from past
periods of time, including benchmark
data from periods prior to the statute’s
enactment. In some cases, the time
periods during which prices are subject
to rebates began as early as several
weeks after the IRA was enacted. In
recognition of this timing, section
1860D–14B(h) of the Act specifically
requires CMS to use program instruction
to implement the Medicare Part D Drug
Inflation Rebate Program for 2022, 2023,
and 2024. Similarly, the existing
provision at section 1847A(c)(5)(C) of
the Act, provides authority for CMS to
implement the Medicare Part B Drug
Inflation Rebate Program using program
instruction or other guidance. In
addition, sections 1847A(i)(1)(C) and
1860D–14B(a)(3) of the Act, as added by
the IRA, permit the Secretary to delay
the issuance of Rebate Reports for
certain initial calendar quarters and
applicable periods until 2025.
Section 1871(e)(1)(A) of the Act
provides that a substantive change in
regulations, manual instructions,
interpretative rules, statements of
policy, or guidelines of general
applicability under Title XVIII of the
Act may not apply retroactively unless
the Secretary has determined that such
retroactive application is necessary to
comply with statutory requirements or
that failure to apply such policies
retroactively would be contrary to the
public interest. To the extent any
proposed provisions in this section III.I
of this proposed rule are considered to
apply retroactively, CMS has
determined that such retroactive
application would be both necessary to
establish policies to implement the
statutory requirements that CMS
perform various calculations that
involve pricing activities from prior
periods and also consistent with the
statutory provisions expressly allowing
the agency to delay the issuance of
rebate reports for initial applicable
periods until 2025. In addition, such
retroactive application would be in the
public interest because it would ensure
that the proposed regulations address
the same time periods and manufacturer
pricing conduct Congress sought to
address in the IRA and would promote
consistency and continuity in program
implementation.
c. Timeline of Key Dates for the
Medicare Prescription Drug Inflation
Rebate Program
As sections 1847A(i)(2)(C) and
1860D–14B(a)(3) of the Act allow for
delayed reporting and invoicing of
rebates amounts for applicable calendar
quarters in 2023 and 2024 for Part B
rebatable drugs and the first two
applicable periods for Part D rebatable
drugs, Figures 1 and 2 provide example
timelines for how rebates will be
calculated for applicable calendar
quarters and one applicable period in
calendar year 2025. The figures also
depict how the rebate period and
components of the rebate calculation
may shift based on the marketing and
approval dates for a rebatable drug or
biological product.
BILLING CODE P
FIGURE 1: Summary of Data Timelines for Part B Drug Inflation Rebate Provisions for
Calendar Year 2025 3
Drug Marketed Before 12/1/2020
Rebate Period 1 for CY2025
Average Total Allowed Charges Calru!at!on Perlod
Payment Amount Benchmark Quarter
Benchmark Period CPi-U
Rebate Period 1 CPl-U (Greater of Jan 2021 CPt-U or}
Average Total Allowed Charges Cak:uiat!on Period
Payment Amount Bem::hma,k Quarter
Benchmark Period CPI-U
Rebate Period 1 CP!-U (Greater of Ju~· 2021 CPl-U}
New Drug Approved After 12/1/2020 and Marketed 1/1/2024
• This graphic is an illustrative example of how rebates for quarters in calendar year 2025 will be calculated.
Note: A drug will be included on the six full calendar quarters (denoted with the numbers in the figure) after the
day the drug was first marketed or the first quarter of2023, whichever is later. The Rebate Period CPI-U is the
greater ofthe benchmark period CPI-U or the CPI-U ofthe first month ofthe quarter two quarters prior to the
rebate period
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Rebate Period 1
Average Tota! Allowed Charges Calculation Period
Payment Amount Benchmark Quarter
Benchmark Period CPI-U
Rebate Period 1 CPI-U (Greater
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
61937
FIGURE 2: Summary of Data Timelines for Part D Drug Inflation Rebate Provisions for
Calendar Year 20253
Drug Marketed on or Before 10/1/2021
Applicable Period 1
: : : a : ~ : ~ d Charges Calculation Period •······'······•······'······•······'······•·
Benchmark Period CP!-.U
Ap licable Period CPI-U
!-----------------~=~.
New Drug Marketed 12/1/2023
AppUcable f'ertod 1
Average Tota! Atlowed .Charges Calculation Period •·····<······>······•·····<······>······•·····•······>·····<···
Benchmark Period
Benchmark: Period CPHJ
A llcable Period CPl·U
This graphic is an illustrative example ofhow rebates for one applicable period including months in
calendar year 2025 will be calculated.
a
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calendar quarters in calendar year 2025
and thereafter for Part B rebates and for
the Part D rebate applicable period
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beginning on October 1, 2024, and
applicable periods thereafter.
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Table 47 describes a summary
timeline for inflation rebate amount
reports and deadlines for applicable
61938
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TABLE 47: Summary of Part Band D Drug Inflation Rebate Amount Reports and
Deadlines a
Manufacturer Reviews
Rebate Report sent to Manufacturers
Manufacturer Rebate Amount Due (if applicable)
Preliminary Reconciliation Rebate Report sent to
Manufacturers
Manufacturer Reviews
Manufacturer Suggestion of Error must be submitted to
CMS not later than IO calendar days following receipt of
the Prelimina Reconciliation Rebate Re ort
Not later than 12 months after receipt of the Rebate Report
Not later than 30 calendar days after receipt of the
Reconciliation Rebate Re ort
Not later than 8 months after the end of the applicable
eriod
Manufacturer Reviews
Manufacturer Suggestion of Error must be submitted to
CMS not later than 10 calendar days following receipt of
the Prelimin
Rebate Re ort
Rebate Report sent to Manufacturers
Not later than 9 months after the end of the applicable
eriod
Manufacturer Rebate Amount Due (if applicable)
Not later than 30 calendar days after receipt of the Rebate
Re ort
First Reconciliation Preliminary Rebate Report sent Not later than 11 months after the receipt of the Rebate
Re ort
to Manufacturers
Manufacturer Reviews
Manufacturer Suggestion of Error must be submitted to
CMS not later than IO calendar days following receipt of
the First Reconciliation Prelimina Rebate Re ort
First Reconciliation Rebate Report sent to
Not later than 12 months after the receipt of the Rebate
Manufacturers
Re ort
Manufacturer Reconciled Rebate Amount Due (if
Not later than 30 calendar days after receipt of the First
an
Reconciliation Rebate Re ort
Second Reconciliation Preliminary Rebate Report
Not later than 35 months after the receipt of the Rebate
sent to Manufacturers
Re ort
Manufacturer Reviews
Manufacturer Suggestion of Error should be submitted to
CMS not later than IO calendar days following receipt of
the Second Reconciliation Prelimina Rebate Re ort
Second Reconciliation Rebate Report sent to
Not later than 36 months after the receipt of the Rebate
Re ort
Manufacturers
Manufacturer Reconciled Rebate Amount Due (if
Not later than 30 calendar days after receipt of the Second
an
Reconciliation Rebate Re ort
a The months referred to in these timelines represent calendar months. This means, for example, that (I a
Preliminary Rebate Report is issued on August 15, 202 7, the Rebate Report could be issued up until
September 30, 2027.
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Reconciliation Rebate Report sent to
Manufacturers
Manufacturer Reconciled Rebate Amount Due (if
uarter
Manufacturer Suggestion of Error must be submitted to
CMS not later than 10 calendar days following receipt of
the Prelimin
Rebate Re ort
Not later than 6 months after the end of the calendar
uarter
Not later than 30 calendar days after receipt of the Rebate
Re ort
Not later than 11 months after receipt of the Rebate Report
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
BILLING CODE C
to proposed subpart B (§§ 427.100
through 427.101):
• ‘‘EUA Declaration’’.
• ‘‘Individual who uses such a drug
or biological’’.
2. Medicare Part B Drug Rebates for
Single Source Drugs and Biological
Products With Prices That Increase
Faster Than the Rate of Inflation
a. Definitions (§ 427.20)
In this proposed rule, CMS proposes
to codify the definitions of terms
consistent with the meanings given in
section 1847A(i) of the Act or
established in the revised Medicare Part
B Drug Inflation Rebate Guidance, as
applicable, as well as new definitions
based on policies detailed in this
proposed rule.
At proposed § 427.20, CMS is
proposing that the following terms in
section 1847A of the Act are defined:
• ‘‘Benchmark period CPI–U’’.
• ‘‘Biosimilar biological product’’.
• ‘‘Inflation-adjusted payment
amount’’.
• ‘‘Part B rebatable drug’’.
• ‘‘Payment amount benchmark
quarter’’.
• ‘‘Payment amount in the payment
amount benchmark quarter’’.
• ‘‘Rebate period CPI–U’’.
• ‘‘Single source drug or biological
product’’.
• ‘‘Specified amount’’.
• ‘‘Subsequently approved drug’’.
• ‘‘Unit’’.
Further, in § 427.20 of this proposed
rule, CMS proposes to codify definitions
established in the revised Medicare Part
B Drug Inflation Rebate Guidance and
new definitions based on policies
detailed in this proposed rule for the
following terms:
• ‘‘Allowed charges’’.
• ‘‘Applicable calendar quarter’’.
• ‘‘Applicable threshold’’.
• ‘‘Average sales price (ASP)’’.
• ‘‘Billing and payment code’’.
• ‘‘Billing unit’’.
• ‘‘CPI–U’’.559
• ‘‘FDA application’’.
• ‘‘Final action claim’’.
• ‘‘First marketed date’’.
• ‘‘Grouped billing and payment
code’’.
• ‘‘Manufacturer’’.
• ‘‘National Drug Code’’ (NDC).
• ‘‘Not Otherwise Classified (NOC)
code’’.
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b. Determination of Part B Rebatable
Drugs (§§ 427.100 Through 427.101)
i. Definitions
In proposed § 427.100, CMS proposes
to define the following terms applicable
559 These data are referenced to 1982–84=100—
that is, the average of pricing data for the 36 months
from 1982 through 1984 serve as the basis for the
index and are assigned a value of 100. These data
are not seasonally adjusted.
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ii. Identification of Part B Rebatable
Drugs
Section 1847A(i)(2) of the Act defines
a ‘‘Part B rebatable drug,’’ in part, as a
single source drug or biological product
(as defined in section 1847A(c)(6)(D)),
including a biosimilar biological
product (as defined in section
1847A(c)(6)(H)), but excluding a
qualifying biosimilar biological product
(as defined in section
1847A(b)(8)(B)(iii)), for which payment
is made under Part B. The definitions
for a biosimilar biological product and
a qualifying biosimilar biological
product are codified in § 414.902.
In § 427.101, CMS proposes to codify
the policies established in section 30.1
of the revised Medicare Part B Drug
Inflation Rebate Guidance to identify
Part B rebatable drugs by (1) identifying
the applicable billing and payment code
for each single source drug or biological
product, including biosimilar biological
products, for which payment is made
under Part B and (2) excluding any
billing and payment code corresponding
to a drug or biological product in
excluded product categories or that have
average total allowed charges below an
applicable threshold, to be codified in
proposed § 427.101(b) and (c),
respectively.560
iii. Excluded Product Categories
Section 1847A(i)(2)(A) of the Act
excludes qualifying biosimilar
biological products (as defined in
section 1847A(b)(8)(B)(iii) of the Act)
from the definition of a Part B rebatable
drug. As such, in § 427.101(b)(1) CMS
proposes to codify the policy
established in section 30.2 of the revised
Medicare Part B Drug Inflation Rebate
Guidance to exclude such products from
the definition of a Part B rebatable drug
and not subject them to Part B inflation
rebates.
Section 1847A(i)(2) of the Act defines
a Part B rebatable drug as a ‘‘single
source drug or biological as defined in
section 1847A(c)(6)(D) of the Act’’
which requires that a single source drug
not be a multiple source drug. CMS has
interpreted section 1847A(c)(6)(C)(ii) of
the Act to mean that single source drugs
560 For more information on HCPCS codes and
how they are applied, see ‘‘HEALTHCARE
COMMON PROCEDURE CODING SYSTEM
(HCPCS) LEVEL II CODING PROCEDURESHCPCS’’
at https://www.cms.gov/medicare/coding/
medhcpcsgeninfo/downloads/2018-11-30-hcpcslevel2-coding-procedure.pdf.
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61939
or biological products are treated as
multiple source drugs if they were
within the same billing and payment
code as of October 1, 2003. Accordingly,
in § 427.101(b)(2), we are proposing to
codify the existing policy established in
section 30.1 of the revised Medicare Part
B Drug Inflation Rebate Guidance to
exclude drugs and biological products
described in section 1847A(c)(6)(C)(ii)
of the Act from the definition of a Part
B rebatable drug and not subject them
to Part B inflation rebates.
For drugs and biological products that
are billed using a HCPCS code that
represents a NOC code, CMS has a
process to determine the allowed
payment amount for such billing and
payment codes; however, current
Medicare claims data do not allow CMS
to determine the average total allowed
charges for such drug or biological
product for a year per individual that
uses such a drug or biological product
or to identify units billed. CMS must
perform these steps to determine if a
drug or biological product is a Part B
rebatable drug. Therefore, in
§ 427.101(b)(3), we are proposing to
codify the policy in section 30.1 of the
revised Medicare Part B Drug Inflation
Rebate Guidance to exclude drugs and
biological products that are billed using
a billing and payment code that
represents a NOC code drug or
biological product or claims for such
drugs and biological products when no
other billing and payment code is
applicable. CMS notes that few Part B
drugs and biological products are billed
with such codes and the quarterly
process for updating billing and
payment codes, including establishing
new billing and payment codes,
provides an existing mechanism for
CMS to minimize the number of Part B
rebatable drugs that are billed with such
codes. As discussed in §§ 90.2 and 90.3
in Chapter 17 of the Medicare Claims
Processing Manual, CMS believes NOC
codes are generally used to bill
Medicare for new-to-market, FDAapproved drug products until a specific
billing and payment code is assigned;
and so, CMS expects that the impact of
this exclusion will be limited.561
Consistent with section 303(h) of the
Medicare Prescription Drug,
Improvement, and Modernization Act of
2003, radiopharmaceutical drugs and
biologicals are not paid under section
1847A of the Act. Manufacturers of
radiopharmaceuticals are therefore not
required to report ASP under section
1927(b)(3) of the Act and are not
561 See: https://www.cms.gov/regulations-andguidance/guidance/manuals/downloads/
clm104c17.pdf.
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otherwise required to report ASP data to
CMS for separately payable
radiopharmaceuticals. In addition,
different payment methodologies across
the outpatient setting result in data
variations that could inappropriately
trigger an inflation rebate amount due to
methodological differences in
reimbursement. Therefore, although
some radiopharmaceuticals may appear
on quarterly pricing files, in
§ 427.101(b)(4) CMS proposes to codify
the revised Medicare Part B Drug
Inflation Rebate Guidance policy (as
described in section 30.1) that excludes
separately payable
radiopharmaceuticals for the purposes
of identifying Part B rebatable drugs.
Additionally, CMS proposes to codify
the existing policy not to subject these
units to the inflation-adjusted
beneficiary coinsurance at § 427.201(c)
and described further in the following
section of this preamble.562
CMS aims to create a consistent
coding and payment approach for the
suite of products currently referred to as
skin substitutes as stated in section 30.1
of revised Medicare Part B Drug
Inflation Rebate Guidance. In the CY
2024 PFS proposed rule, CMS solicited
comments on potential changes to
payment for skin substitutes. In the CY
2024 PFS final rule, CMS acknowledged
the comments received in response to
this solicitation and stated that CMS
would take these comments into
consideration for future rulemaking.563
In § 427.101(b)(5) CMS proposes to
codify existing policy to exclude
cellular- and tissue-based products that
would aid wound healing, currently
referred to as skin substitutes, for the
purposes of identifying Part B rebatable
drugs. In addition, CMS proposes not to
subject these products to the beneficiary
coinsurance adjustment at § 427.201(c).
Section 1847A(i)(2)(A) of the Act
excludes from the definition of a Part B
rebatable drug a drug or biological if, as
determined by the Secretary, the average
total allowed charges for such drug or
biological product under Part B for a
year per individual who uses such a
drug or biological product are less than
$100. Section 1847A(i)(2)(B) of the Act
562 In this proposed rule, CMS also is proposing
to clarify how radiopharmaceuticals are paid for in
the physician’s office and to codify these policies
in regulation. Specifically, CMS proposes to clarify
that for radiopharmaceuticals furnished in a setting
other than the hospital outpatient department,
MACs can determine payment limits for
radiopharmaceuticals based on any methodology in
place on or prior to November 2003.
563 See 88 FR 78818, November 16, 2023 (https://
www.federalregister.gov/public-inspection/202324184/medicare-and-medicaid-programs-calendaryear-2024-payment-policies-under-the-physicianfee-schedule).
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provides that the $100 amount for 2023
will be increased for 2024 and
subsequent years by the percentage
change in the CPI–U for the 12-month
period ending with June of the previous
year, rounded to the nearest multiple of
$10. Therefore, in § 427.101(b)(6) CMS
proposes to codify the policy
established in revised Medicare Part B
Drug Inflation Rebate Guidance to
exclude from the definition of a Part B
rebatable drug those drugs and
biologicals for which the Part B average
total allowed charges for a year per
individual who uses such drug or
biological is below the applicable
threshold.
Section 1847A(i)(2)(A)(ii) of the Act
excludes vaccines described in
subparagraph (A) or (B) of section
1861(s)(10) of the Act from the
definition of a Part B rebatable drug.
Such vaccines include the
pneumococcal vaccine, the influenza
vaccine, the COVID–19 vaccine; and the
hepatitis B vaccine when furnished to
an individual who is at high or
intermediate risk of contracting
hepatitis B (as determined by the
Secretary under regulations). As such,
in § 427.101(b)(7), CMS proposes to
codify the existing policy established in
section 30.3 of the revised Medicare Part
B Drug Inflation Rebate Guidance to
exclude vaccines described in
subparagraph (A) or (B) of section
1861(s)(10) of the Act from the
definition of a Part B rebatable drug and
not subject them to Part B inflation
rebates. In addition, with respect to
monoclonal antibodies used for
treatment or post-exposure prophylaxis
of COVID–19, which are covered and
paid for under section 1861(s)(10) of the
Act, CMS proposes to exclude these
products from the definition of Part B
rebatable drugs for applicable quarters
through the end of the calendar year in
which the EUA declaration under
section 564 of the FD&C Act for drugs
and biological products is terminated.
With respect to monoclonal antibodies
that are used for pre-exposure
prophylaxis of COVID–19 that are
covered and paid for under section
1861(s)(10) of the Act, CMS proposes to
exclude these products from the
definition of Part B rebatable drug for
applicable calendar quarters even after
the year in which the EUA Declaration
ends, as long as these products have an
FDA-approved application or license
after the EUA Declaration is terminated.
Finally, Part B drugs approved under
an Abbreviated New Drug Application
(ANDA) submitted under 505(j) of the
FD&C Act do not meet the definition of
‘‘single source drug or biological
product,’’ as defined under section
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1847A(c)(6)(D) of the Act, and thus, are
not Part B rebatable drugs. We propose
to codify this exclusion at
§ 427.101(b)(8).
iv. Drugs and Biological Products With
Average Total Allowed Charges Below
the Applicable Threshold
Pursuant to section 1847A(i)(2) of the
Act, drugs and biological products, for
which the average total allowed charges
for such drug or biological under Part B
for a year per individual who uses such
drug or biological are below the
applicable threshold, as determined by
the Secretary, are excluded from the
definition of Part B rebatable drugs. As
explained in section 30.2 of the revised
Medicare Part B Drug Inflation Rebate
Guidance, CMS uses the term
‘‘applicable threshold’’ to mean $100 for
all four calendar quarters in 2023. For
all four calendar quarters in 2024, the
applicable threshold will be $100 as
increased in accordance with section
1847A(i)(2)(B) of the Act. For calendar
quarters in 2025 and beyond, the
applicable threshold will be equal to the
unrounded applicable threshold
calculated for the prior calendar year,
increased by the percentage increase in
the CPI–U for the 12-month period
ending with June of the previous year.
In § 427.101(c), CMS is proposing to
codify policies from the revised
Medicare Part B Drug Inflation Rebate
Guidance to exclude these drugs from
the definition of a Part B rebatable drug.
To do so, in accordance with the statute,
for each applicable calendar quarter,
CMS proposes to identify drugs and
biological products with Part B average
total allowed charges for a year per
individual that uses such a drug or
biological product below the applicable
threshold.
In § 427.101(c)(1), CMS is proposing
that to identify the average total allowed
charges for a year per individual, for
each Part B rebatable drug, CMS would:
• For single source drugs and
biological products assigned to only one
billing and payment code, sum the
allowed charges from final action claims
greater than $0 and divide the summed
amount by the number of individuals
who use such a drug or biological.
• For single source drugs and
biological products assigned to more
than one billing and payment code, sum
the allowed charges from final action
claims greater than $0 for all billing and
payment codes and divide the summed
amount by the number of individuals
who use such a drug or biological.
CMS may move a drug or biological
product from a grouped billing and
payment code to a unique billing and
payment code in instances where the
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drug is either approved through the
pathway established under section
505(b)(2) of the FD&C Act (hereinafter
‘‘section 505(b)(2) drug products’’) that
CMS initially assigned to the same
billing and payment code as its
reference drug for a period of time, or
the drug was previously a multiple
source drug but is now a single source
drug that was moved to its own billing
and payment code. There may be
instances where a single source drug or
biological product was previously
crosswalked to a grouped billing and
payment code (other than a NOC code)
during the full year. In such instances,
CMS proposes to calculate the average
total allowed charges per individual per
year for the drug using allowed charges
and the number of individuals who
used the drug or biological product
based on claims for the previously
grouped billing and payment code
during the year. Such instances would
apply to section 505(b)(2) drug
products, drugs that were previously
multiple source drugs where all other
drugs under the same billing and
payment code were discontinued
(applicable only if the sole remaining
product was not approved under an
ANDA), and to any other situations
where a drug was previously in a
grouped billing and payment code
(other than a NOC code).
Finally, there may be instances where
a single source drug or biological
product was initially billed under a
grouped billing and payment code
(other than a NOC code) and was later
billed under a unique billing and
payment code for some of the year. In
such instances, CMS proposes to
calculate the average total allowed
charges per individual for a year by:
summing the total allowed charges
billed under the unique billing and
payment code for the drug with dates of
service on or after the Medicare effective
date for this unique billing and payment
code and identifying the individuals on
those claims; summing the total allowed
charges on claims billed under the
previously grouped billing and payment
code and identifying the individuals
with claims prior to the unique billing
and payment code’s effective date; and
then summing the total allowed charges
under both billing and payment codes
across the full year and dividing by the
total number of individuals (deduplicated for those individuals
identified under both the previously
grouped billing and payment code and
the unique billing and payment code). If
the average total allowed charges for a
year per individual who uses such drug
or biological product are less than the
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applicable threshold, CMS proposes to
exclude the billing and payment code
for that calendar quarter. CMS
welcomes comment on the proposed
implementation of the exclusion for
drugs and biologicals with average total
allowed charges below the applicable
threshold.
CMS proposes in § 427.101(c)(2) to
calculate the applicable threshold as
follows:
• For applicable calendar quarters in
2023, the applicable threshold is equal
to $100.
• For applicable calendar quarters in
2024, the applicable threshold is equal
to $100 increased by the percentage
increase in the CPI–U for the 12-month
period ending with June of 2023.
• For applicable calendar quarters in
each subsequent calendar year, the
applicable threshold is equal to the
unrounded applicable threshold
calculated for the prior calendar year
increased by the percentage increase in
the CPI–U for the 12-month period
ending with June of the previous year.
• If the resulting amount from these
calculations is not a multiple of $10,
CMS will round that amount to the
nearest multiple of $10.564
Accordingly, the formula to determine
the applicable threshold for calendar
quarters in 2024 is $100 multiplied by
(CPI–U for June 2023 divided by CPI–U
for June 2022) (apply rounding to the
nearest multiple of $10). To illustrate,
the 2024 threshold is: 100 × (305.109/
296.311) = 102.969178 (which rounds
down to $100 after applying CMS
rounding) so the threshold for calendar
quarters in 2024 = $100.
For the purposes of this calculation,
CMS proposes that ‘‘a year’’ means the
4 consecutive calendar quarters
beginning 6 calendar quarters before the
applicable calendar quarter. CMS also
proposes using final action claims from
the Medicare fee-for-service claims
repository to identify claims where
separate payment was allowed for the
applicable HCPCS code for dates of
service within a year. Drugs and
biological products that do not meet the
applicable threshold are not considered
Part B rebatable drugs. For example, for
the calendar quarter beginning July 1,
2025, CMS would use available final
action Medicare Part B claims with
dates of service beginning January 1,
2024, and ending December 31, 2024,
because January 1, 2024, is the
beginning of the calendar quarter that is
6 quarters before the applicable calendar
quarter beginning on July 1, 2025.
564 CMS will round any amount less than $5 over
a multiple of $10 down to that multiple of $10, and
any amount $5 or more over a multiple of $10 up
to the next multiple of $10.
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61941
In § 427.101(c)(3), CMS proposes to
codify the policies and methodological
steps as described in section 30.2 of the
revised Medicare Part B Drug Inflation
Rebate Guidance for excluding drugs
and biological products with average
total allowed charges below the
applicable threshold at the billing and
payment code level. For each applicable
calendar quarter, CMS would identify
the applicable billing and payment
codes for drugs and biological products
with average total allowed charges for a
year per individual less than the
applicable threshold and exclude such
drugs and biological products from the
definition of Part B rebatable drug in
accordance with proposed
§ 427.101(b)(6). When a single source
drug or biological product with average
total allowed charges below the
applicable threshold is assigned to a
unique billing and payment code, CMS
would exclude the assigned billing and
payment code for the applicable
calendar quarter. There also may be
instances where a single source drug or
biological product is assigned to more
than one billing and payment code
during a year and the average total
allowed charges for a year per
individual that uses such drug or
biological product are less than the
applicable threshold. In such instances,
CMS proposes to exclude all assigned
billing and payment codes for such
single source drug or biological product
for that applicable calendar quarter.
c. Inflation-Adjusted Beneficiary
Coinsurance Adjustment and Adjusted
Medicare Payment for Part B Rebatable
Drugs With Price Increases Faster Than
Inflation (§§ 427.200 Through 427.201)
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 payment
amount described 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 payment
amount described 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 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
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selected drug. In the CY 2024 Hospital
Outpatient Prospective Payment System
(OPPS) final rule and the CY 2024 PFS
final rule, CMS codified this inflationadjusted coinsurance amount at
§§ 419.41(e), 410.152(m), and
489.30(b)(6), respectively.
Beginning with the April 2023
quarterly pricing files, the applicable
beneficiary coinsurance percentage is
shown for each HCPCS code in the
pricing files that are posted on the CMS
website. For example, the ASP Pricing
files are posted at https://www.cms.gov/
medicare/payment/part-b-drugs/asppricing-files. The applicable beneficiary
coinsurance percentage for certain drugs
and biologicals used predominantly in
the hospital outpatient setting are listed
in the Hospital Outpatient Prospective
Payment System (OPPS) Addenda A
and B, which can be found at https://
www.cms.gov/medicare/payment/
prospective-payment-systems/hospitaloutpatient/addendum-a-b-updates. The
applicable beneficiary coinsurance
percentage for certain drugs and
biologicals used predominantly in the
ambulatory surgical center setting are
listed in the ASC Addendum, which can
be found at https://www.cms.gov/
medicare/payment/prospectivepayment-systems/ambulatory-surgicalcenter-asc/asc-payment-rates-addenda.
The percentage is expressed as two
digits with three decimal places, for
example, 18.760. If an adjusted
beneficiary coinsurance does not apply,
the percentage would show as 20.000.
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 payment amount
under section 1847A(i)(3)(A)(ii)(I) of the
Act or, in the case of a selected drug, the
payment amount described in section
1847A(b)(1)(B) of the Act, for that drug
exceeds the inflation-adjusted payment
amount for a Part B rebatable drug, the
Part B payment amount would, subject
to the Part B deductible and
sequestration, equal the difference
between the payment limit and the
inflation-adjusted coinsurance amount.
Consistent with the clarification in
section 40 of the revised Medicare Part
B Drug Inflation Rebate Guidance and
with the application of sequestration in
the context of Medicare payment and
beneficiary coinsurance in general, we
note that the calculation to determine
the applicable beneficiary coinsurance
amount would not be adjusted for
sequestration. CMS codified the
Medicare payment for Part B rebatable
drugs in the CY 2024 PFS final rule by
adding new paragraph (m) to § 410.152.
In this proposed rule, CMS proposes
to adopt new provisions at §§ 427.200
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and 427.201 to codify the policies
regarding the computation of the
inflation-adjusted beneficiary
coinsurance, defined in § 427.200, for
Part B rebatable drugs as required by
section 1847A(i)(5) of the Act. This
proposed new provision includes
references to the existing provisions at
§§ 410.152(m), 419.41(e), and
489.30(b)(6). CMS further proposes at
§ 427.201(c) that any category of
products that is excluded from the
identification of Part B rebatable drugs
at § 427.101(b) is not subject to the
inflation-adjusted beneficiary
coinsurance. Examples of these
excluded products include separately
payable radiopharmaceuticals, skin
substitute products, and qualifying
biosimilar biological products.
Additionally, CMS proposes at
§ 427.201(b) that CMS will use the
published payment amount in quarterly
pricing files565 566 567 to determine if a
Part B rebatable drug should have an
adjusted beneficiary coinsurance equal
to 20 percent of the inflation-adjusted
payment amount as described in section
1847A(i)(3)(C) for a calendar quarter.
This proposed approach deviates from
the rebate calculation approach
proposed in § 427.302, which relies on
the specified amount defined at § 427.20
even when the specified amount and the
published payment amount in quarterly
pricing files differ. The approach
proposed at § 427.201(b) would be used
only to determine whether there should
be a coinsurance adjustment and would
not impact the applicability or
calculation of inflation rebates. CMS
believes this approach is consistent with
the statutory language and appropriately
reflects the differences in the statutory
text of section 1847A(i)(5) of the Act,
which sets forth the payment amount
that is used to determine whether
coinsurance should be adjusted, and
section 1847A(i)(3)(A) of the Act, which
sets forth the ‘‘specified amount’’ used
to determine rebate amounts.
CMS’ intent with this proposed policy
is to hold beneficiaries harmless in
situations where the payment amount is
calculated differently from the specified
amount. Though the payment amount is
generally based on the same provisions
as the specified amount, there may be
situations where the payment amount is
updated or adjusted under other
provisions of 1847A of the Act, such as
565 See: https://www.cms.gov/medicare/payment/
part-b-drugs/asp-pricing-files.
566 See: https://www.cms.gov/medicare/payment/
prospective-payment-systems/hospital-outpatient/
addendum-a-b-updates.
567 See: https://www.cms.gov/medicare/payment/
prospective-payment-systems/ambulatory-surgicalcenter-asc/asc-payment-rates-addenda.
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when ASP data are not available under
section 1847A(c)(5)(B). For example, if
the specified amount is very low due to
negative ASP data and the payment
amount is updated using other available
data resulting in a payment amount that
exceeds the inflation-adjusted payment
amount, beneficiaries would not receive
the benefit of adjusted coinsurance.
There may also be situations where the
payment amount is lower than the
inflation-adjusted payment amount, but
the specified amount is higher than the
inflation-adjusted payment amount. In
such a situation, if the ‘‘specified
amount’’ was used as the comparator to
determine whether coinsurance should
be adjusted, beneficiaries would pay a
coinsurance higher than 20 percent,
because 20 percent of the inflationadjusted payment amount would be
higher than 20 percent of the payment
amount. As such, we propose to codify
at § 427.201(b) that we will compare the
published payment amount in the
quarterly pricing files published by
CMS to determine whether a
coinsurance adjustment applies. This
policy would provide an adjusted
beneficiary coinsurance amount only
when the payment amount for a Part B
rebatable drug exceeds the inflationadjusted payment amount in a given
quarter.
CMS believes this approach is valid
and gives effect to the differing statutory
language in sections 1847A(i)(3)(A),
1847A(i)(5), and 1833(a)(1)(EE) of the
Act, which sets forth the coinsurance
adjustment for Part B rebatable drugs.
Unlike the ‘‘specified amount’’ in
section 1847A(i)(3)(A), sections
1847A(i)(5) and 1833(a)(1)(EE) both
refer to a ‘‘payment amount.’’
Fundamentally, a payment amount
cannot be a negative number; if the
specified amount and payment amount
were the same amount, it would result
in situations where the payment amount
at section 1833(a)(1)(EE) was a negative
number. Rather, we believe that the
term ‘‘payment amount’’ in both
sections 1847A(i)(5) and 1833(a)(1)(EE)
is most naturally read to include the
amount, as updated and adjusted for the
purposes of providing payment to
providers, that CMS publishes as the
payment amount in quarterly pricing
files; and that section 1833(a)(1)(EE)
operates to adjust the percentage of such
payment amount. Furthermore, section
1847A(i)(5)(B) of the Act provides the
Secretary with discretion to apply the
adjusted coinsurance percentage to the
payment amount that would otherwise
apply under section 1847A(b)(1)(B) or
(C) of the Act. Lastly, sections
1847A(i)(8)(D) and (E) of the Act
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preclude administrative and judicial
review of the computation of the
adjusted coinsurance and amounts paid
to the provider under section
1833(a)(1)(EE).
In summary, we are proposing CMS
will use the payment amount in
quarterly pricing files to determine if a
Part B rebatable drug should have an
adjusted beneficiary coinsurance, the
calculation to determine the adjusted
Medicare payment (if applicable) will
not be adjusted for sequestration, and
drugs excluded from the identification
of Part B rebatable drugs will not be
subject to the inflation-adjusted
beneficiary coinsurance. CMS invites
comment on these proposals.
d. Determination of the Rebate Amount
for Part B Rebatable Drugs (§§ 427.300
Through 427.304)
i. Definitions
In proposed § 427.300, CMS proposes
to define the following terms applicable
to subpart D (§§ 427.300 through
427.304):
• ‘‘340B Program’’.
• ‘‘Refundable single-use dose
container or single-use package drug’’.
lotter on DSK11XQN23PROD with PROPOSALS2
ii. Calculation of the Total Part B Rebate
Amount To Be Paid by Manufacturers
Section 1847A(i)(3) of the Act
specifies the calculation of the rebate
amount for a Part B rebatable drug
assigned to a billing and payment code
for an applicable calendar quarter for
which a manufacturer must pay a
rebate. CMS proposes to codify the
rebate calculation, as established in
revised Medicare Part B Drug Inflation
Rebate Guidance, as the estimated
amount is equal to the product of the
total number of billing units determined
in accordance with section
1847A(i)(3)(B) of the Act (proposed at
§ 427.303) and the amount (if any) by
which the specified amount (proposed
at § 427.302(b)) exceeds the inflationadjusted payment amount determined
in accordance with section
1847A(i)(3)(C) of the Act (proposed at
§ 427.302(g)) for the drug or biological
product for an applicable calendar
quarter. The Part B drug inflation rebate
amount calculated in accordance with
this subpart is subject to adjustment
based on any reductions in accordance
with subpart E of this part or any
reconciliations in accordance with
subpart F of the part.
Because Part B rebatable drugs are
single source drugs or biologicals, they
typically will have one manufacturer.
However, a Part B rebatable drug could
have more than one manufacturer. For
example, a Part B rebatable drug could
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be produced by one or more
manufacturer(s) that is a repackager or
relabeler. Multiple manufacturers of a
rebatable drug also could 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 instances, all the
NDCs for the drug typically are assigned
to the same billing and payment code(s),
and each manufacturer is responsible
for reporting ASP data to CMS. When
calculating the rebate owed by
manufacturers for a rebatable drug that
has more than one manufacturer, CMS
proposes to codify the policy from
section 50.13 of the revised Medicare
Part B Drug Inflation Rebate Guidance to
multiply the total rebate amount
calculated for the billing and payment
code by the following quotient:
(Sum of the individual manufacturer’s
billing units sold during the
applicable calendar quarter for all
NDCs of the manufacturer assigned
to the billing and payment code, as
reported in the ASP data
submissions) divided by (Sum of all
manufacturers’ total billing units
sold during the applicable calendar
quarter for all NDCs of the Part B
rebatable drug assigned to the
billing and payment code, as
reported in the ASP data
submissions)
CMS welcomes comment on this
calculation approach.
Based on further review, CMS has
observed that there are several instances
where there are multiple manufacturers
in a billing and payment code and the
ASP data, including the number of units
sold, for all or some manufacturers’
NDCs within a billing and payment
code may be negative, zero, or missing.
To enable CMS to calculate the
respective rebate amounts attributable to
each manufacturer when the ASP units
are negative, zero, or missing, CMS is
soliciting comments on the new
proposed policies outlined below and
any other alternative options.
(1) Scenarios in Which All NDCs Within
a Billing and Payment Code Have
Negative, Zero, or Missing ASP Units
If there are NDCs of multiple
manufacturers in a billing and payment
code, to determine the respective rebate
amount when the manufacturerreported ASP units for all NDCs are
either negative, zero, or missing but
there is a positive rebate amount
calculated for the Part B rebatable drug,
CMS proposes to: (1) apportion a $0
rebate amount when the reported units
for all NDCs are missing for NDCs not
marketed or sold during the applicable
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61943
calendar quarter, negative, and/or zero;
and (2) equally apportion a positive
rebate amount to each NDC with
missing units when the NDCs were
marketed or sold during the applicable
calendar quarter. If the NDCs within a
billing and payment code have a mix of
negative units, zero units, missing units
for NDCs marketed or sold during the
applicable calendar quarter, or missing
units for NDCs not marketed or sold
during the applicable calendar quarter,
CMS will apportion a $0 rebate amount
to the NDCs with missing units that are
not marketed or sold during the
applicable calendar quarter, NDCs with
negative units, and NDCs with zero
units, and will equally apportion the
positive rebate amount across all NDCs
with missing units that are marketed or
sold during the applicable quarter. CMS
understands that this approach would
treat missing units for NDCs not
marketed or sold during the applicable
calendar quarter, negative units, and
zero units as representing zero sales,
and we welcome comments on the
extent to which this approach could
potentially exclude from rebate liability
a manufacturer of a drug that did have
sales in that quarter (for example, if
negative units represent price
concessions). In addition, CMS
welcomes comments on the extent to
which, in a scenario with a billing and
payment code with multiple
manufacturers, a single manufacturer
with missing ASP units could assume
full rebate liability for the entire billing
and payment code if the manufacturer’s
NDCs have missing units and are
marketed or sold during the applicable
calendar quarter.
CMS also considered several
alternative policies for attributing rebate
amounts to each respective
manufacturer in this scenario,
including: (1) using the reported ASP
units from the calendar quarter prior to
the applicable calendar quarter; (2)
using an average of units sold based on
sales data for several calendar quarters
prior to the applicable calendar quarter
(for example, an average of the previous
four calendar quarters); and (3)
validation of ASP data based on review
of AMP data in combination with one of
the aforementioned alternative proposed
policies to determine inflation rebate
amounts. However, CMS has observed
that ASP units are often negative, zero,
or missing for several quarters in a fourquarter lookback, so including
additional quarters may not necessarily
yield additional data that could be used
to apportion inflation rebate amounts
(and could complicate the calculation of
an average by introducing a mix of zero,
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negative, missing, and positive units
within a single NDC). In addition, the
AMP validation of ASP sales could add
another layer of complexity and
potential bias as AMP data represent
only sales to retail community
pharmacies, and ASP data represent all
sales of a drug. CMS welcomes
comments on these alternatives.
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(2) Scenarios in Which Some (But Not
All) NDCs Have Negative, Zero, or
Missing ASP Units
When some manufacturers’ NDCs
within a billing and payment code
report negative, zero, or missing ASP
units, CMS proposes to: (1) treat any
NDCs with missing units that are not
marketed or sold during the applicable
calendar quarter, negative units, or zero
units as not having any sales for the
applicable calendar quarter and
apportion a $0 rebate amount to them;
(2) treat NDCs with missing units that
are marketed or sold during the
applicable calendar quarter as though
they had the same units as that of the
NDC with the lowest positive units; and
(3) apportion rebate amounts across
NDCs with missing units that are
marketed or sold during the applicable
calendar quarter and NDCs with
positive units based on the share of ASP
units sold in accordance with the policy
outlined in section 50.13 of the revised
Medicare Part B Drug Inflation Rebate
Guidance. CMS welcomes comments on
the extent to which, in a scenario where
NDCs of multiple manufacturers are
assigned to the same billing and
payment code, a single manufacturer
that accounts for all positive ASP units
could potentially be responsible for the
full rebate amount for the entire billing
and payment code.
CMS also considered proposing other
alternative policies for attributing rebate
amounts to each respective
manufacturer in this scenario,
including: (1) review of historical ASP
data to identify the most recent calendar
quarter with positive ASP units for any
of the NDCs with negative, zero, or
missing units in the applicable calendar
quarter and allocation of financial
responsibility across NDCs with positive
ASP units in that quarter (excluding
NDCs without positive units in that
quarter); (2) using an average of units
sold based on sales data for several
calendar quarters prior to the applicable
quarter (for example, an average of the
previous four calendar quarters); (3)
apportionment of rebates based on units
at the NDC–9 level rather than the NDC–
11 level; and (4) apportionment of
rebates to only those manufacturers
within a HCPCS code that reported
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positive ASP units for the applicable
calendar quarter.
CMS elected to not propose use of a
historical lookback approach (under
options 1 and 2) since ASP units are
often negative, zero, or missing for the
most recent calendar quarter and/or
over several quarters in a four-quarter
lookback period, and so including
additional quarters may not necessarily
yield additional data that could be used
to apportion inflation rebate amounts
(and could complicate the calculation of
an average by introducing a mix of zero,
negative, missing, and positive units
within a single NDC). CMS also
understands that a historical lookback
approach could create outliers that
could affect the resulting allocation.
When evaluating option 3, CMS
observed that ASP units are often
negative, zero, or missing for several
calendar quarters when aggregating
units sold at the NDC–9 level.
Consequently, this approach may not
necessarily yield additional data that
could be used to apportion inflation
rebate amounts and doing so would
differ from our general policy on using
NDC–11s as set forth in the revised
guidance. Finally, CMS decided not to
propose apportioning the full rebate
amount to only those manufacturers that
reported positive ASP units within a
billing and payment code under option
4, as we questioned whether that policy
could inadvertently disfavor
manufacturers that reported units while
benefiting manufacturers that did not
report ASP data. We continue to
evaluate these alternative policy
approaches for apportioning rebate
liability and may adopt changes to this
proposed policy in the final rule.
CMS reminds manufacturers of their
reporting obligations under sections
1847A(f)(2) and 1927(b) of the Act and
that failure to provide timely
information may result in penalties as
detailed in sections 1847A(d)(4)(B) and
(C) and 1927(b)(3)(C)(i) of the Act.
CMS welcomes comments on these
proposed approaches as well as
alternative policy options on how CMS
could apportion rebate amounts among
multiple manufacturers’ NDCs that
reported negative, zero, and/or missing
units for NDCs.
iii. Calculation of the Per Unit Part B
Drug Rebate Amount
(1) Identification of the Specified
Amount for the Applicable Calendar
Quarter
In the calculation of the rebate
amount for a Part B rebatable drug, CMS
is statutorily required to compare the
inflation-adjusted payment amount to
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the specified amount, which is the
amount set forth in section
1847A(i)(3)(A)(ii)(I) of the Act. Statute
also requires CMS to impose an
inflation rebate if the specified amount
exceeds the inflation-adjusted payment
amount. CMS proposes to codify at
§ 427.302(a) the policy established in
revised Medicare Part B Drug Inflation
Rebate Guidance to calculate the Part B
per unit rebate amount for the
applicable calendar quarter by
determining the amount by which the
specified amount exceeds the inflationadjusted payment amount, after
accounting for exclusions under
§ 427.303(b). CMS proposes to codify
the current operational steps for
calculating Part B inflation rebates as
described in section 50 of the revised
Medicare Part B Drug Inflation Rebate
Guidance.
In § 427.302(b), CMS proposes to
codify the policy established in section
50.2 of the revised Medicare Part B Drug
Inflation Rebate Guidance on how to
calculate the specified amount for the
applicable calendar quarter. The
‘‘specified amount’’ refers to the amount
specified in section
1847A(i)(3)(A)(ii)(I)(aa) or (bb) of the
Act, as applicable. In general, section
1847A(i)(3)(A)(ii)(I)(aa) and (bb) of the
Act cross-reference provisions
governing quarterly payment limits for
single source drugs and biological
products that are typically, but not
always, reflected in the quarterly pricing
files. Specifically, the specified amount
for single source drugs and biological
products is 106 percent of the amount
determined under section 1847A(b)(4)
of the Act—that is, the lesser of ASP or
WAC—for the applicable calendar
quarter. For biosimilar biological
products, the specified amount is the
payment amount under section
1847A(b)(1)(C) of the Act, which is
based on 100 percent of the ASP for the
biosimilar biological product plus 6
percent of the lesser of ASP or WAC for
the reference biological product.
In § 427.302(b)(1), CMS proposes that
the first applicable calendar quarter for
a Part B rebatable drug will be the
earliest applicable calendar quarter that
follows the payment amount benchmark
quarter identified in § 427.302(c)(1)
through (6).
Additionally, for the purposes of
determining the rebate amount for a Part
B rebatable drug, based on further
consideration of data availability in
specific circumstances, CMS proposes
to clarify the policy established in
section 50 of the revised Medicare Part
B Drug Inflation Rebate Guidance and
use the most updated price information
reported by manufacturers, determined
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lotter on DSK11XQN23PROD with PROPOSALS2
in accordance with section
1847A(i)(3)(A)(ii)(I)(aa) or (bb) of the
Act as applicable, as the specified
amount for the applicable calendar
quarter for each HCPCS code identified
in accordance with § 427.101. That is,
CMS would use the most updated price
information reported by manufacturers
to compare whether 106 percent of
WAC or 106 percent of ASP is less, and
would use the lower value for the
specified amount. In circumstances in
which all NDCs in the HCPCS code have
neither manufacturer-reported ASP nor
WAC price data available for the
applicable calendar quarter, CMS
proposes to use WAC price data from
other public sources, if available, to
calculate 106 percent of WAC, which
will serve as the specified amount. CMS
proposes to adopt this approach
regardless of whether there is a price
substitution for Medicare’s payment
during the quarter or whether other
policies cause the published payment
limit to differ from the specified
amount. In circumstances in which
negative or zero manufacturer ASP data
is reported for all NDCs for a given
quarter, that negative or zero ASP
amount would be used to compare 106
percent of WAC to 106 percent of ASP
to determine the lower value for use as
the specified amount. CMS believes
these proposals on treatment of missing
pricing data and treatment of pricing
differences between reported prices and
the published payment limit for a
billing and payment code will further
clarify the application of the specified
amount in the calendar quarter are
consistent with the requirements set
forth in section 1847A(i)(3)(A)(ii)(I) of
the Act. CMS solicits comments on this
policy.
(2) Identification of the Payment
Amount Benchmark Quarter
In § 427.302(c), CMS proposes to
codify policies from section 50.3 of the
revised Medicare Part B Drug Inflation
Rebate Guidance to identify the
applicable payment amount benchmark
quarter. Specifically, for drugs first
approved or licensed by the FDA on or
before December 1, 2020, and with a
first marketed date on or before
December 1, 2020, the payment amount
benchmark quarter would be the
calendar quarter beginning July 1, 2021.
For subsequently approved drugs—that
is, drugs approved or licensed by the
FDA after December 1, 2020—the
payment amount benchmark quarter
would be the third full calendar quarter
after a drug’s first marketed date.
Additionally, there may be cases where
a drug was first approved or licensed on
or before December 1, 2020, but with a
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first marketed date after December 1,
2020, and the drug lacks ASP or WAC
data to calculate the payment amount
for the applicable calendar quarter
beginning July 1, 2021. Under the policy
applicable to drugs approved or
licensed and with a first marketed date
before December 1, 2020, such drugs
would not have data to calculate the
payment amount in the payment
amount benchmark quarter. In these
cases, CMS proposes to treat such drugs
in the same manner as it would treat
subsequently approved drugs and
identify the payment amount
benchmark quarter as the third full
calendar quarter after a drug’s first
marketed date. CMS solicits comments
on this policy proposal and specifically
on our proposal to treat drugs approved
or licensed on or before December 1,
2020, but with a first marketed date after
December 1, 2020 as subsequently
approved drugs.
For Part B rebatable drugs that were
billed under a NOC code during the
payment amount benchmark quarter,
CMS stated in the revised Medicare Part
B Drug Inflation Rebate Guidance that it
would use the third full quarter after a
drug was assigned a unique HCPCS
code as the payment amount benchmark
quarter. In this rulemaking, CMS
proposes to determine the payment
amount benchmark quarter as follows:
For a Part B rebatable drug that was
billed under a NOC code during the
calendar quarter beginning July 1, 2021,
or the third full calendar quarter after
such drug’s first marketed date,
whichever is later, CMS proposes that
the payment amount benchmark quarter
be the third full calendar quarter after
the Part B rebatable drug is assigned a
billing and payment code other than a
NOC code. CMS solicits comments on
these proposals.
CMS continues to consider whether
there is a need to identify additional or
modified methodologies to
appropriately determine the payment
amount benchmark quarter for products
with insufficient pricing data in the
payment amount benchmark quarter or
that otherwise do not fall squarely into
the categories otherwise described in
§ 427.302(c) and in a manner that
enables the calculation of rebate
amounts consistent with section
1847A(i)(3) of the Act.
CMS has determined that ASP data
are the most appropriate for identifying
(1) the day on which the drug was first
marketed and (2) which calendar
quarter is the third full calendar quarter
thereafter as the payment amount
benchmark quarter for drugs first
approved or licensed by the FDA after
December 1, 2020, or licensed on or
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61945
before December 1, 2020, but with a first
marketed date after December 1, 2020.
CMS also has determined that it is most
appropriate and administratively
feasible to identify the first marketed
date as the date of first sale of any NDC–
11 within a billing and payment code
among all products and package sizes
under the same FDA application.
Additionally, CMS believes ASP data
are accurate and reliable because
manufacturers attest to the accuracy of
their submitted data and have the ability
to update these data quarterly.
Therefore, in § 427.302(c), CMS
proposes to codify existing policy from
the revised Medicare Part B Drug
Inflation Rebate Guidance on the
identification of the payment amount
benchmark quarter for each Part B
rebatable drug. CMS would use the
earliest first marketed date of any NDC
ever marketed under any FDA
application under which any NDCs that
have ever been assigned to the billing
and payment code for that Part B
rebatable drug as of the applicable
calendar quarter have ever been
marketed. The earliest first marketed
date would apply to all NDCs within a
billing and payment code and to all
products and package sizes marketed
under the same FDA approved
application. If the original NDC on
which the first marketed date is based
is terminated, the first marketed date for
the associated billing and payment code
would remain the same. By defining the
first marketed date for the Part B
rebatable drug at the level of the
product’s FDA approval, CMS would
retain the same first marketed date for
the billing and payment code even if the
NDCs and/or billing and payment codes
used to bill for the Part B rebatable drug
change over time. In addition, when the
date of first sale is missing from ASP
data, CMS proposes to identify the first
marketed date from alternative public
sources, such as the National Institutes
of Health’s DailyMed.
Table 48 in this section provides an
example, for illustration purposes only,
of the application of first marketed date
based on the earliest date of first sale of
any NDC ever marketed under any NDA
or BLA under which any NDCs that
have ever been assigned to the billing
and payment code as of the applicable
calendar quarter have ever been
marketed. In the example, NDC1
(marketed under NDA 000000) is first
sold on January 15, 2022, and NDC2
(also marketed under NDA 000000) is
first sold on October 15, 2023. Both
NDCs are marketed under an NDA
associated with HCPCS code X0000.
The first marketed date for HCPCS code
X0000 would be January 15, 2022,
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because that date is the earliest date of
first sale for any NDC that has ever been
associated with an NDA or BLA within
that HCPCS code as of the calendar
quarter. If NDC2 were subsequently
assigned to a new HCPCS code Y0000,
the first marketed date for HCPCS
Y0000 would similarly be January 15,
2022. In cases when NDCs that are
marketed under different NDA/BLAs are
assigned to the same HCPCS code, using
the example in the table in this section,
NDC3 (marketed under NDA 111111)
was first sold on November 1, 2024, and
first billed under HCPCS Y0000, and the
first marketed date for HCPCS Y0000
would remain January 15, 2022, as
noted, given that HCPCS Y0000
includes NDC2, associated with NDA
000000. NDC3 was later assigned to a
new HCPCS code Z0000. Following
CMS’ approach, the first marketed date
for HCPCS code Z0000 is November 1,
2024, because that is the earliest date of
first sale for any NDC ever marketed
under NDA 111111, which is the only
NDA ever associated with Z0000 as of
the calendar quarter.
lication of First Marketed Date at the FDA A
xoooo
2024 QI
2024 2
2024 Q3
2024 Q4
xoooo
xoooo
2025 QI
Y0000
Y0000
Y0000
20000
(3) Identification of Payment Amount in
the Payment Amount Benchmark
Quarter
lotter on DSK11XQN23PROD with PROPOSALS2
Section 1847A(i)(3)(C) of the Act
specifies use of the ‘‘payment amount
for the billing and payment code for
such drug in the payment amount
benchmark quarter’’ (‘‘payment amount
in the payment amount benchmark
quarter’’) in the determination of the
inflation-adjusted payment amount.
While the specified amount and the
payment amount in the payment
amount benchmark quarter are similar,
the statutory requirements for
determining these two amounts differ.
The specified amount for a Part B
rebatable drug, as set forth in section
1847A(i)(3)(A)(ii)(I) of the Act, is based
on item (aa) (for example, lesser of
ASP+6 percent or WAC+6 percent) or
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4/1/2023
4/1/2023
4/1/2023
4/1/2023
4/1/2023
4/1/2023
4/1/2023
7/1/2024
7/1/2024
7/1/2024
7/1/2024
1/1/2025
(bb) (that is, 100 percent of the ASP for
the biosimilar biological product plus 6
percent of the lesser of ASP or WAC for
the reference biological product). The
payment amount in the payment
amount benchmark quarter under
section 1847A(i)(3)(C)(i) is based on
various provisions within section 1847A
of the Act (for example, the lesser of 106
percent ASP or WAC, WAC+3 percent,
and price substitutions). To identify the
payment amount in the payment
amount benchmark quarter for the Part
B rebatable drug by billing and payment
code, in § 427.302(d), CMS proposes to
codify the policies established in
section 50.4 of the revised Medicare Part
B Drug Inflation Rebate Guidance. CMS
would use the published payment limit
(as available) for the billing and
payment code for the applicable
payment amount benchmark quarter
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1/15/2022
1/15/2022
1/15/2022
1/15/2022
1/15/2022
1/15/2022
1/15/2022
1/15/2022
1/15/2022
11/1/2024
1/15/2022
11/1/2024
determined in accordance with section
1847A of the Act. If a published
payment limit is not available for the
applicable payment amount benchmark
quarters, CMS would use the lower of
106 percent of manufacturer-reported
ASP or 106 percent of manufacturerreported WAC. If neither a published
payment limit nor manufacturerreported ASP or WAC data are available,
CMS would use WAC data from other
public sources to calculate 106 percent
of WAC, which, solely for the purposes
of identifying the payment amount in
the payment amount benchmark
quarter, CMS would consider to be the
payment amount for the payment
amount benchmark quarter. Table 49
and Figure 3 illustrate the specified
amount and payment amount in the
payment amount benchmark quarter.
BILLING CODE P
E:\FR\FM\31JYP2.SGM
31JYP2
EP31JY24.079
2023 Q4
1/15/2022
1/15/2022
10/15/2023
1/15/2022
10/15/2023
I 0/15/2023
10/15/2023
I 0/15/2023
10/15/2023
11/1/2024
10/15/2023
11/1/2024
000000
000000
000000
000000
000000
000000
000000
000000
000000
111111
000000
111111
NDCI
NDC2
NDCI
NDC2
NDC2
NDC2
NDC2
NDC2
NDC3
NDC2
NDC3
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
61947
TABLE 49: Comparison of Specified Amount and Payment Amount in the Payment
Amount Benchmark Quarter
Specified Amount
Purpose in Rebate
Calculation
Pricing Methodology
Under
1847A(i)(3)(A)(ii)(I)
• Lesser of ASP+6% or
WAC+6%
• In the case of a
biosimilar biological
product, 100% of ASP for
the biosimilar biological
product + 6% of the lesser
of ASP or WAC for the
reference biological
product
Part B amount described
under
1847A(i)(3)(A)(ii)(l) for
the calendar quarter in
which a rebate may be
assessed
Payment Amount in the Payment Amount
Benchmark Quarter
Purpose in Rebate
Pricing Methodology
Calculation
Under 1847A(i)(3)(C)(i)
Part B published payment
limit for the payment
amount benchmark
quarter, which is
generally the quarter
beginning July 1, 2021
• Various Part B pricing
provisions consistent with
section 1847A of the Act
FIGURE 3: Use of the Specified Amount and the Payment Amount in the Benchmark
Quarter in Rebate Calculations
Inflation-
Billing Units in the
Rebate Amount
c::::::::J
c::::::::J
Applicable Calendar
c:::::J
Adjusted
Payment
Quarter
··•Payment Amount ur• •
Inflation-Adjusted
Payment Amount*
c::::::::J
c::::::::J
••·· ~e ~~YmentAmo~t ••
~
Rebate Period CPI-U divided by
Benchmark Period CPI-U
l3encbmarl< ;uarter •
CMS notes that there may be
situations when a Part B rebatable drug
was previously billed under a grouped
billing and payment code during the
benchmark quarter and later billed
under a unique billing and payment
code, such as certain section 505(b)(2)
drug products and single source drugs
that were previously multiple source
drugs. For example, a multiple source
drug approved under an NDA may
become a single source drug if all other
therapeutically equivalent drugs are no
longer marketed and the now-single
source NDA is later shifted into a
separately payable code. To identify the
payment amount in the payment
amount benchmark quarter for such
drugs, CMS proposes to codify policy
established in section 50.4 of the
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Medicare Part B Drug Inflation Rebate
Guidance and identify the grouped
billing and payment code payment limit
used by CMS for the payment amount
in the payment amount benchmark
quarter and use that payment limit for
the benchmark quarter.
Finally, consistent with the policy
established in section 50.4 of the revised
Medicare Part B Drug Inflation Rebate
Guidance, CMS would not apply a
sequestration reduction to the payment
amount in the payment amount
benchmark quarter as part of the
methodology to calculate a Part B
inflation rebate amount.
(4) Identification of the Benchmark
Period CPI–U
For each Part B rebatable drug by
HCPCS code, the statute requires CMS
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to identify the applicable benchmark
period CPI–U. In accordance with
section 1847A(i)(3)(E) of the Act, the
benchmark period CPI–U for drugs first
approved or licensed by the FDA on or
before December 1, 2020, and with a
first marketed date on or before
December 1, 2020, is the CPI–U for
January 2021, which is 261.582.568 CMS
proposes to codify in § 427.302(e)
policies established in section 50.5 of
the revised Medicare Part B Drug
Inflation Rebate Guidance. Specifically,
the benchmark period CPI–U for drugs
first approved or licensed on or before
December 1, 2020, with a first marketed
date after December 1, 2020, would be
the CPI–U for the first month of the
568 CMS retrieved the January 2021 CPI–U from
bls.gov on March 22, 2024.
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BILLING CODE C
EP31JY24.081
* See the next section for information about identification and calculation of the inflation-adjusted payment amount.
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third full calendar quarter after a drug’s
first marketed date. Additionally, CMS
proposes to codify policies in revised
guidance that the benchmark period
CPI–U for subsequently approved drugs
would be the first month of the first full
calendar quarter after a drug’s first
marketed date in accordance with
section 1847A(i)(4)(A) of the Act.
Furthermore, CMS proposes to
determine the benchmark period CPI–U
for certain drugs previously billed under
NOC codes as follows: For a Part B
rebatable drug that was billed under a
NOC code during the calendar quarter
beginning July 1, 2021, or the third full
calendar quarter after such drug’s first
marketed date, whichever is later, CMS
proposes that the benchmark period
CPI–U would be first month of the third
full calendar quarter after the drug is
assigned a billing and payment code
other than a NOC code. CMS solicits
comments on these proposals.
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(5) Identification of the Rebate Period
CPI–U
As specified in section 1847A(i)(3)(F)
of the Act, in § 427.302(f), CMS
proposes to codify the policy described
in section 50.6 of the revised Medicare
Part B Drug Inflation Rebate Guidance,
that the rebate period CPI–U means the
greater of the benchmark period CPI–U
index level and the CPI–U index level
for the first month of the calendar
quarter that is 2 calendar quarters prior
to the applicable calendar quarter in
which the Part B rebatable drug is
furnished. CMS will retrieve the CPI–U
index level information from bls.gov.
(6) Determination of the InflationAdjusted Payment Amount
Section 1847A(i)(3)(C) of the Act
specifies the determination of the
inflation-adjusted payment amount. In
§ 427.302(g), CMS proposes to codify
the policy established in section 50.7 of
revised Medicare Part B Drug Inflation
Rebate Guidance for determining the
inflation-adjusted payment amount in
accordance with this section of the Act.
For each applicable calendar quarter
and for each Part B rebatable drug by
billing and payment code, CMS
proposes to use the payment amount in
the payment amount benchmark quarter
(per § 427.302(d)), benchmark period
CPI–U (per § 427.302(e)), and rebate
period CPI–U (per § 427.302(f)) to
identify the inflation-adjusted payment
amount. Specifically, CMS would
calculate the inflation-adjusted payment
amount by dividing the rebate period
CPI–U by the benchmark period CPI–U
and then multiplying the quotient by
the payment amount in the payment
amount benchmark quarter.
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iv. Determination of Total Number of
Billing Units
For calendar quarters starting on or
after January 1, 2023, CMS proposes in
§ 427.303 to codify policies established
in section 50.8 of the revised Medicare
Part B Drug Inflation Rebate Guidance to
determine the number of billing units
for each Part B rebatable drug by HCPCS
code. Section 1847A(i)(3)(B) describes
the total number of billing units of Part
B rebatable drugs that should be
included in the rebate calculation.
These billing units include the number
of billing units for the HCPCS code of
the Part B rebatable drug furnished
during the relevant calendar quarter
minus billing units of drugs with
respect to which the manufacturer
provides a discount under the 340B
Program, billing units with respect to
which the manufacturer could have
paid a Medicaid rebate, and billing units
that are packaged into the payment
amount for an item or service and are
not separately payable. CMS further
proposes codifying policy set forth in
revised Medicare Part B Drug Inflation
Rebate Guidance in § 427.303 to exclude
billing units when a drug is no longer
a Part B rebatable drug.
After identifying Part B rebatable
drugs by HCPCS code (in accordance
with policy proposed in §§ 427.10,
427.20, and 427.100 through 427.101)
using final action claims in the CMS
Medicare fee-for-service claims
repository, CMS proposes to codify
existing policy in the revised Medicare
Part B Drug Inflation Rebate Guidance
in § 427.303 to determine the total
number of billing units for each HCPCS
code as follows. CMS identifies claim
lines for such HCPCS code for dates of
service in the calendar quarter, excludes
billing units in claim specified in
section 1847A(i)(3)(B)(ii) of the Act, as
applicable, and sums the number of
billing units in the remaining claim
lines for which Medicare payment was
allowed and greater than zero. Including
billing units where Medicare payment
was allowed would ensure that billing
units for which Medicare and some
beneficiaries have financial liability
would be counted in the total number
of billing units.
CMS proposes to codify the policy in
the revised Medicare Part B Drug
Inflation Rebate Guidance in § 427.303
and will perform this process at least 3
months after the end of a calendar
quarter to allow time for claims to be
submitted, processed, and finalized.
Subpart F of this proposed rule
describes the proposed rebate process,
including reports of rebate amounts,
suggestion of error, and restatements.
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CMS welcomes comment on the
following policies and comments on any
additional units that should be excluded
from the rebate amount calculation.
(1) Units of Drugs Acquired Through the
340B Program
Section 1847A(i)(3)(B)(ii)(I) of the Act
specifically excludes billing units of
drugs for which the manufacturer
provides a discount under the 340B
Program from the billing units of drugs
for which a manufacturer may otherwise
have a Part B inflation rebate liability.
CMS proposes codifying the policy
described in section 50.8.1 of the
revised Medicare Part B Drug Inflation
Rebate Guidance in § 427.303 to remove
separately payable billing units in claim
lines that are billed with the ‘‘JG’’ or
‘‘TB’’ modifiers from identified final
action claim lines.
On December 20, 2022, CMS issued
program guidance that requires all 340B
covered entities to include the ‘‘JG’’ or
‘‘TB’’ modifier, as applicable, on
separately payable claim lines for drugs
acquired through the 340B Program
with dates of service beginning no later
than January 1, 2024.569 CMS proposes
to codify this requirement in
§ 427.303(b)(1)(ii). Furthermore, on
November 22, 2023, in the CY 2024
OPPS final rule (88 FR 81791 through
81792), CMS finalized a policy to utilize
a single 340B modifier (‘‘TB’’), requiring
hospitals that currently report the ‘‘JG’’
modifier to use the ‘‘TB’’ modifier
beginning January 1, 2025. As described
in the final rule, in CY 2024, these
hospitals can choose to continue to use
the ‘‘JG’’ modifier or choose to transition
to the use of ‘‘TB’’ modifier during that
year. On December 14, 2023, CMS
updated the December 20, 2022
guidance titled ‘‘Part B Inflation Rebate
Guidance: Use of the 340B Modifiers’’ to
align with the updated single modifier
requirement.570
CMS proposes in § 427.303(b)(1)(i) to
exclude separately payable billing units
in claim lines for professional claims
with dates of service during 2023 from
suppliers that are covered entities listed
by the HRSA 340B Office of Pharmacy
Affairs Information System as
participating in the 340B Program. CMS
will use National Provider Identifier
numbers and/or Medicare Provider
Numbers to identify these suppliers and
the claims submitted with such
identifiers. CMS proposes to continue
this approach for professional claims
569 See: https://www.cms.gov/files/document/
part-b-inflation-rebate-guidance340bmodifierfinal.pdf.
570 See: https://www.cms.gov/files/document/
revised-part-b-inflation-rebate-340b-modifierguidance.pdf.
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with dates of service during 2024.
Consistent with the CMS updated 340B
modifier guidance, CMS proposes in
§ 427.303(b)(1)(ii) excluding separately
payable billing units in claim lines for
institutional providers with the ‘‘JG’’
and ‘‘TB’’ modifiers from identified
final action claims with dates of service
through December 31, 2024. CMS
proposes to codify policies established
in section 50.8.1 of the revised Medicare
Part B Drug Inflation Rebate Guidance
in § 427.303(b)(1)(iii) by excluding
separately payable billing units in claim
lines with the ‘‘TB’’ modifier from
identified final action claims with dates
of service on or after January 1, 2025.
CMS is proposing to use these modifiers
to identify and exclude billing units for
which a discount was acquired under
the 340B Program because the ‘‘TB’’
modifier is an existing mechanism used
to identify drugs acquired through the
340B Program and familiar to most 340B
covered entities paid under the OPPS.
(2) Units With a Rebate Under Section
1927 of the Social Security Act
To receive payment under Medicaid
for covered outpatient drugs,
manufacturers must participate in the
Medicaid Drug Rebate Program (that is,
have a drug rebate agreement in effect
with the Secretary of HHS) and are
required to report certain pricing and
drug product information and pay
Medicaid drug rebates for covered
outpatient drugs furnished and paid for
under the Medicaid State plan. States
invoice manufacturers no later than 60
days after the end of each calendar
quarter on the number of units of each
dosage form and strength of each
covered outpatient drug furnished and
paid for under the State plan. This
invoice includes units of covered
outpatient drugs that are furnished to
dually eligible beneficiaries when the
claim for the drug is paid for by
Medicare Part B and the beneficiary’s
cost sharing is covered by Medicaid. To
determine unit counts for rebate
calculations, at this time, in
§ 427.303(b)(2), CMS proposes codifying
our policy described in revised
Medicare Part B Drug Inflation Rebate
Guidance in section 50.8.2 to exclude
billing units from claims with dates of
service during a month within a
calendar quarter when the Medicare
beneficiary has Medicaid coverage that
may provide cost-sharing assistance.
These are Qualified Medicare
Beneficiary (QMB) Plus, Specified LowIncome Medicare Beneficiary (SLMB)
Plus, QMB-only beneficiaries, and other
full dually eligible beneficiaries. CMS
further proposes codifying the policy in
revised guidance that billing units for
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Part B rebatable drugs furnished to
Medicare beneficiaries with Medicaid
coverage that does not include costsharing assistance (that is, SLMB Only,
Qualified Disabled and Working
Individuals (QDWI), and Qualifying
Individuals (QI) beneficiaries) be
included in rebate calculations. CMS
would identify the months for which a
beneficiary has Medicaid coverage with
cost-sharing assistance using available
information (for example the State
MMA File of dually eligible
beneficiaries) at the time the rebate
amount is being calculated for a
calendar quarter. CMS proposes
codifying this policy as manufacturers
pay rebates through the Medicaid Drug
Rebate Program on units of covered
outpatient drugs that are furnished to
dually eligible beneficiaries when the
claim for the drug is paid for by
Medicare Part B and the beneficiary’s
cost sharing is covered by Medicaid.
CMS also considered excluding all
units furnished to dually eligible
individuals but is not proposing this
alternative as it would result in the over
exclusion of units.
(3) Units That Are Packaged Into the
Payment Amount for an Item or Service
and Are Not Separately Payable
As described earlier in this section,
CMS proposes codifying our policy in
section 50.8.3 of revised Medicare Part
B Drug Inflation Rebate Guidance and
only include claim lines with a
Medicare allowed amount greater than
zero. Because CMS proposes in
§ 427.303(b)(3) identifying billing units
for separately payable claim lines for
Part B rebatable drugs only, no further
action would be necessary to exclude
billing units that are packaged into the
payment amount for an item or service
and are not separately payable, such as
drugs for which payment is packaged
under the OPPS, or the Ambulatory
Surgical Center (ASC) payment system,
or those furnished in the Federally
qualified health centers (FQHC) or rural
health clinics (RHC) setting. CMS notes
that claim lines for drugs for which
payment is bundled under the EndStage Renal Disease (ESRD) prospective
payment system would not have a
Medicare allowed amount that is greater
than zero and such units would
therefore be excluded.
In accordance with policies
established in the CY 2024 OPPS/ASC
final rule and codified in regulatory text
at 88 FR 81540, CMS would except
biosimilar biological products from the
OPPS threshold packaging policy when
their reference biological products are
separately paid. This means that CMS
would pay separately for these
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61949
biosimilar biological products even if
their per-day cost is below the threshold
packaging policy. Because units of these
biosimilar biological products are not
packaged into the payment amount for
an item or service and are separately
payable, they would be included in the
Part B inflation rebate calculation if they
are not qualifying biosimilar biological
products.
(4) Units When a Drug Is No Longer a
Part B Rebatable Drug
As described in section 1847A(i)(2) of
the Act, multiple source drugs are not
Part B rebatable drugs. A single source
drug that is a Part B rebatable drug
could become a multiple source drug at
the start of or during a calendar quarter.
In such cases, in § 427.303(b)(4), CMS
proposes codifying policy in section
50.8.4 of the revised Medicare Part B
Drug Inflation Rebate Guidance to
identify the first marketed date, as
described in § 427.20, of a drug product
that is rated as therapeutically
equivalent to such a drug under FDA’s
most recent publication of Approved
Drug Products with Therapeutic
Equivalence Evaluations (commonly
known as the FDA Orange Book 571) and
determine whether the drug is no longer
a Part B rebatable drug. In
§ 427.303(b)(4), CMS proposes to
exclude billing units of such drug
furnished on and after the first day of
the calendar month in which the
therapeutically equivalent drug was first
sold or marketed during the applicable
calendar quarter. CMS further proposes
codifying policy that it may consult
with the FDA for technical assistance in
instances where there is ambiguity as to
whether a new product is
therapeutically equivalent. Units
furnished on or after the calendar month
of the first marketed date would be
excluded from the units identified in
accordance with § 427.303(b)(4)(iii).
(5) Operational Considerations Related
to the Inclusion of Units Furnished to
Beneficiaries Who Are Enrolled in
Medicare Advantage (MA) Plans
Section 1847A(i) of the Act requires
the manufacturer of a Part B rebatable
drug to pay a rebate that, generally, is
calculated based on the total number of
billing units of that drug that were
furnished in a calendar quarter,
multiplied by the excess specified
amount for the drug over a statutorily
defined inflation-adjusted payment
amount. The inclusion in this
571 Accessible via https://www.fda.gov/drugs/
drug-approvals-and-databases/approved-drugproducts-therapeutic-equivalence-evaluationsorange-book.
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calculation of billing units of drugs that
are furnished to Medicare beneficiaries
who are enrolled in MA plans poses
significant operational complexities. At
this time, CMS is not proposing to
establish a policy on treatment of MA
units in the calculation of Part B
inflation rebates due to operational
considerations, but may establish policy
on this issue in future rulemaking. CMS
solicits comments on this approach.
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(6) Units Subject to Discarded Drug
Refunds
In § 427.303(b)(5), CMS proposes a
policy addressing the interaction
between Part B inflation rebates and
billing units of discarded drugs. Under
the Infrastructure Investment and Jobs
Act of 2021, section 90004,
manufacturers are required to provide a
refund to CMS for certain discarded
amounts from separately payable singledose container or single-use package
drugs beginning January 1, 2023. To
implement the discarded drugs refund
provision of the Infrastructure
Investment and Jobs Act of 2021, in the
CY 2023 PFS final rule (87 FR 69711
through 69719), CMS finalized the
requirement that providers and
suppliers use the ‘‘JW’’ claim modifier
for all separately payable drugs with
discarded amounts of drugs from a
single-dose container or from a singleuse package Part B claims that bill for
drugs and biological products to report
discarded amounts. CMS also finalized
a requirement for providers and
suppliers to use the ‘‘JZ’’ modifier on
claims that bill for drugs from singledose containers that are separately
payable under Medicare Part B when
there are no discarded amounts to attest
that no amount of drug was discarded
and eligible for payment.572 As of
October 1, 2023, claims for drugs from
single-dose containers that do not use
the modifiers as appropriate may be
returned until claims are properly
resubmitted.
Although section 1847A(i)(3)(B)(ii) of
the Act does not require that billing
units of discarded drugs be excluded
from Part B inflation rebates, CMS is
proposing to exclude billing units of
discarded drugs that are subject to
discarded drug refunds from Part B
inflation rebates. CMS believes not
applying Part B inflation rebates to
billing units of discarded drugs for
which a refund is owed would balance
fairness for manufacturers that owe
refunds for billing units of discarded
drugs with the need to fulfill the
572 See 87 FR 2512, November 18, 2022 (https://
www.federalregister.gov/d/2022-23873/p-2512).
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requirements of section 11101 of the
IRA.
As new policy not established in
section 50.8.6 of the revised Medicare
Part B Drug Inflation Rebate Guidance,
CMS proposes to exclude billing units
of a refundable single-dose container or
single-use package drug as defined in
§ 414.902 (hereinafter referred to as
‘‘refundable drug’’) subject to discarded
drug refunds, from the calculation of
rebate amounts during the
reconciliation process except for
calendar quarters in calendar year 2023.
In the CY 2024 PFS final rule (codified
in § 414.940), CMS finalized policy to
send annual refund reports for
discarded drug refunds for the 4
quarters of a calendar year at or around
the time it sends Part B Inflation Rebate
Reports for the first quarter of the
following calendar year. Therefore, CMS
invoices manufacturers for discarded
drug refunds on an annual basis but
CMS is required to invoice
manufacturers for Part B inflation
rebates on a quarterly basis.
Under the timeline for processing
discarded drug refunds, data to
determine which billing units of
discarded drugs are subject to discarded
drug refunds will generally not be
available until after CMS issues the
Rebate Report to the manufacturer. Due
to these data limitations, CMS proposes
to include all discarded billing units,
including units of a refundable drug
subject to the discarded drug refund (as
defined in § 414.940), in the calculation
of billing units for the Preliminary
Rebate Report and the Rebate Report.
CMS proposes to use data available
during the reconciliation process to
exclude billing units of discarded drugs
that are subject to discarded drug
refunds from the calculation of the
rebate amount.
For calendar quarters in calendar year
2023, CMS proposes to exclude billing
units of a refundable drug subject to
discarded drug refunds from the
calculation of the rebate amount before
CMS issues the Rebate Report to the
manufacturer. As permitted by section
1847A(i)(1)(C) of the Act, CMS is
delaying reporting of rebate information
required by section 1847A(i)(1)(A) for
calendar quarters in calendar years 2023
and 2024 until no later than September
30, 2025. Under this timeline for
calendar quarters in calendar year 2023,
CMS will have data available regarding
which billing units are subject to
discarded drug refunds when CMS
sends the Preliminary Rebate Report
and Rebate Report in 2025 for calendar
quarters in calendar year 2023 and can
exclude these billing units from the
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calculation of the rebate amount in
these reports.
CMS solicits comments on the
proposed approach to excluding billing
units of a refundable drug subject to
discarded drug refunds, from the
calculation of Part B inflation rebate
amounts during the reconciliation
process, except for calendar quarters in
calendar year 2023.
v. Adjustments for Changes to Billing
and Payment Codes
Changes to billing and payment
codes, including new code assignments
and dose description changes, may
occur.
When a new billing and payment
code is assigned for a Part B rebatable
drug and the code dose description,
which determines that amount of drug
in each billing unit, remains the same,
CMS proposes to codify in § 427.304(b)
the existing policy set forth in revised
Medicare Part B Drug Inflation Rebate
Guidance to use the benchmark
quarter’s payment amount, the payment
amount benchmark quarter, and the
benchmark quarter CPI–U of the prior
billing and payment code to calculate
the per unit Part B rebate amount. For
example, a single source drug or
biological product may be assigned a
new billing and payment code if it was
initially assigned to a billing and
payment code with other products and
then later assigned a unique billing and
payment code. In this situation, a
multiple source drug in an NDA may
become a single source drug if all its
other therapeutically equivalent drugs
are discontinued and the now-single
source NDA is later shifted into a
separately payable code.
When a Part B rebatable drug’s code
dose description changes, CMS
proposes to codify in § 427.304(a)
policies established in section 50.9 of
the revised Medicare Part B Drug
Inflation Rebate Guidance and apply a
conversion factor within the rebate
calculation, when applicable. For
example, a billing and payment code
dose description that determines the
amount of drug in each billing unit
could be changed from 10mg to 5mg. If
a billing and payment code dose
description changes from 10mg to 5mg,
the payment amount in the payment
amount benchmark quarter for such
drug was $200 based on 10mg, and the
rebate period payment amount is based
on 5mg, then CMS would apply a
conversion factor of 0.5 to the payment
amount in the payment amount
benchmark quarter (yielding $100). In
this example, the conversion factor
would be based on the ratio of the
current billing unit description to the
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prior billing unit description (5mg/10mg
= 0.5). In addition, to ensure
consistency in how CMS is calculating
a rebate when a billing and payment
code’s dose description changes, CMS
proposes to apply a conversion factor
before applying the percentage by which
the rebate period CPI–U for the calendar
quarter exceeds the benchmark period
CPI–U to determine the inflationadjusted payment amount.
In situations where a new billing and
payment code is assigned for a Part B
rebatable drug and the code dose
description changes, CMS would apply
a conversion factor, as appropriate, and
use the benchmark quarter’s payment
amount, the payment amount
benchmark quarter, and the benchmark
quarter CPI–U of the prior billing and
payment code to calculate the per unit
Part B rebate amount—consistent with
the policy in revised guidance that CMS
is proposing to codify in § 427.304(a)
and (b).
To apply the provisions in section
1847A(i) of the Act appropriately, CMS
also proposes in § 427.304(c) to codify
existing policy to maintain a crosswalk
between such changes or codes.
CMS solicits comment on these
proposals.
e. Reducing the Rebate Amount for Part
B Rebatable Drugs in Shortage and
When There Is a Severe Supply Chain
Disruption (§§ 427.400 Through
427.402)
Section 1847A(i)(3)(G) of the Act
requires the Secretary to reduce or
waive the rebate amount owed by a
manufacturer for a Part B rebatable drug
with respect to a calendar quarter in two
cases: (1) when a Part B rebatable drug
is described as currently in shortage on
a shortage list in effect under section
Dru2 Shorta2e
Indefinite for as long as drug is "currently in shortage"
Duration of Reduction
Percent Reduction
First four consecutive
calendar quarters
Second four consecutive
calendar quarters
Subsequent calendar
auarters
Part B rebatable drug
other than a plasmaderived product
25%
Part B rebatable plasmaderived product
61951
506E of the FD&C Act at any point
during the applicable period; and (2)
when CMS determines there is a severe
supply chain disruption during the
applicable quarter for a Part B rebatable
biosimilar biological product, such as a
disruption caused by a natural disaster
or other unique or unexpected event.
The statute does not describe how CMS
should reduce or waive inflation rebates
in each of these cases.
To implement the statutory
requirement under section
1847A(i)(3)(G), CMS proposes to codify
in subpart E of part 427 existing policies
described in sections 50.10, 50.11, and
50.12 of the revised Medicare Part B
Drug Inflation Rebate Guidance to
reduce the total rebate amount owed by
a manufacturer in each of these cases, as
summarized in Table 50 and discussed
later in this section.
Severe Suooly Chain D1@.iiUion
Four calendar quarters; manufacturer
may request an extension for four
additional quarters for up to eight
calendar quarters total
Part B rebatable biosimilar biological
product
75%
75%
10%
50%
75%
2%
25%
Not applicable
As proposed, the rebate amount owed
would not be fully waived in either of
the cases previously described. CMS
believes the proposed rebate reduction
policies balance providing appropriate
financial relief for manufacturers in
certain circumstances, including when
there is a severe supply disruption
resulting from exogenous circumstances
outside of a manufacturer’s control,
while not incentivizing manufacturers
to delay taking appropriate steps to
resolve a drug shortage or severe supply
chain disruption to avoid an obligation
to pay rebates. CMS will continue to
evaluate these policies and may update
them in future years. CMS underscores
that most shortages involve multiple
source generic drugs,573 which are not
573 See: https://www.iqvia.com/insights/the-iqviainstitute/reports-and-publications/reports/drugshortages-in-the-us2023.
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Part B rebatable drugs and thus are not
subject to Part B drug inflation rebates.
CMS solicits comments on the proposed
approach.
i. Definitions
CMS proposes in § 427.400 to define
the following terms applicable to
proposed subpart E (§§ 427.400 through
427.402)—
• ‘‘Drug shortage’’ or ‘‘shortage’’.
• ‘‘Plasma-derived product’’.
Proposed § 427.400 also would codify
definitions established in the revised
Medicare Part B Drug Inflation Rebate
Guidance for the following terms:
• ‘‘Currently in shortage’’.
• ‘‘Natural disaster’’.
• ‘‘Other unique or unexpected
event’’.
• ‘‘Severe supply chain disruption’’.
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ii. Reducing the Rebate Amount for Part
B Rebatable Drugs Currently in Shortage
In proposed § 427.401, CMS proposes
to codify the policy established in
section 50.11 of the revised Medicare
Part B Drug Inflation Rebate Guidance
whereby CMS would reduce the total
rebate amount for a Part B rebatable
drug that is currently in shortage based
on the length of time the drug is in
shortage during a calendar quarter and
decrease the amount of the reduction
over time. CMS intends to use the
shortage lists maintained by the FDA
Center for Biologics Evaluation and
Research (CBER) and Center for Drug
Evaluation and Research (CDER) to
determine whether a Part B rebatable
drug is currently in shortage 574 during
574 For the purposes of this proposed rule, CMS
uses the term ‘‘currently in shortage’’ to refer to Part
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a calendar quarter. CMS will not
consider an NDC–10 in the status of ‘‘to
be discontinued,’’ ‘‘discontinued,’’ or
‘‘resolved’’ to be ‘‘currently in
shortage.’’ At this time, CMS intends to
provide the same reduction in the rebate
amount for Part B rebatable drugs
currently in shortage regardless of the
cause of the shortage.
CMS will not provide a full waiver of
the rebate amount for drugs currently in
shortage on an FDA shortage list, as
providing a full waiver of the rebate
amount could further incentivize
manufacturers to delay taking
appropriate steps that may resolve a
shortage more expeditiously simply to
maintain having the drug listed on
FDA’s drug shortage list to avoid an
obligation to pay rebates for an extended
period. Further, in a report analyzing
the root causes of drug shortages
between 2013 and 2017, FDA found that
more than 60 percent of drug shortages
were the result of manufacturing or
product quality issues, and providing a
full waiver of the rebate amount in
situations that may be within a
manufacturer’s control could be
perceived as rewarding manufacturers
for poor quality management.575
CMS would be responsible for
monitoring the status of a Part B
rebatable drug on an FDA shortage list,
and manufacturers would not need to
submit any information to CMS to be
eligible for a reduction of the rebate
amount for a Part B rebatable drug that
is currently in shortage.
To calculate the reduced total rebate
amount for a Part B rebatable drug, in
§ 427.401(b), CMS proposes the
following formula:
Reduced Total Rebate Amount = total
rebate amount multiplied by (1
minus applicable percent
reduction) multiplied by
(percentage of time drug was
currently in shortage during the
calendar quarter) added to the total
rebate amount multiplied by (1
minus percentage of time drug was
currently in shortage during the
calendar quarter)
For the purpose of this formula, for a
Part B rebatable drug that is a plasmaderived product, in § 427.401(b)(2)(i),
CMS proposes an applicable percent
reduction of 75 percent for the first 4
consecutive calendar quarters such Part
B rebatable drug is currently in shortage,
50 percent for the second 4 consecutive
B rebatable drugs that are in the status of ‘‘currently
in shortage’’ on the CDER shortage list, as well as
biological products listed on CBER’s current
shortages list.
575 See: https://www.fda.gov/media/131130/
download?attachment#page=33.
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calendar quarters, and 25 percent for
each subsequent calendar quarter. For a
Part B rebatable drug (including a
biosimilar biological product) that is not
a plasma-derived product, in
§ 427.401(b)(2)(ii), CMS proposes an
applicable percent reduction of 25
percent for the first 4 consecutive
calendar quarters such Part B rebatable
drug is currently in shortage, 10 percent
for the second 4 consecutive calendar
quarters, and 2 percent for each
subsequent calendar quarter.
Because drugs and biologicals on the
FDA shortage lists are maintained at the
NDC–10 level, and Part B drug inflation
rebates are calculated at the HCPCS
level, CMS proposes in § 427.401(c) that
if any NDC–10 assigned to the HCPCS
code(s) is currently in shortage, CMS
would apply the rebate reduction to all
of the NDCs under the relevant HCPCS
code(s). CMS will closely monitor
market data for the Part B rebatable
drugs for which the rebate is reduced to
ensure the integrity of the application of
the rebate reduction policy.
CMS intends to provide a reduction in
the rebate amount for as long as a Part
B rebatable drug is currently in shortage.
CMS believes the rebate reduction
should be proportional to the time the
drug is currently in shortage and
decrease over time to balance providing
financial relief to manufacturers
experiencing a drug shortage while not
incentivizing manufacturers to delay
taking appropriate steps to resolve a
shortage simply to maintain having the
drug listed on an FDA shortage list to
avoid an obligation to pay rebates for an
extended period.
To determine the percentage of time
a Part B rebatable drug was currently in
shortage during the calendar quarter, as
proposed in § 427.401(b)(3), CMS would
count the number of days such drug is
currently in shortage in a calendar
quarter and divide by the total number
of days in that calendar quarter.
In § 427.401(b)(2), CMS proposes
codifying the policy set forth in section
50.11 of the revised Medicare Part B
Drug Inflation Rebate Guidance to apply
a greater applicable percent reduction
for plasma-derived products than nonplasma derived products because the
former rely on a variable supply of
donated blood plasma that can impact
downstream production and therefore
hamper the ability to promptly resolve
a shortage.
When the status of a Part B rebatable
drug changes from currently in shortage
to resolved during a calendar quarter
and then changes to currently in
shortage during one or more of the
subsequent three calendar quarters,
CMS would apply the shortage
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reduction as if there was a continuous
shortage beginning with the quarter in
which the drug has re-entered a shortage
and move to the percent reduction
applicable for the second four
consecutive quarters. (In this scenario,
once this drug enters its fifth quarter of
shortage from the first quarter in which
it was listed as currently in shortage, the
applicable percent reduction would be
50 percent for the fifth through eighth
calendar quarters for a Part B rebatable
drug that is a plasma-derived product
and 10 percent for a Part B rebatable
drug that is not a plasma-derived
product.) When the status of a Part B
rebatable drug changes from currently in
shortage to resolved and either remains
in the status of resolved or is removed
from the list for at least 4 full
consecutive calendar quarters and then
subsequently reemerges on a shortage
list, CMS would treat the subsequent
shortage as a new shortage and would
apply the applicable percent reduction
for the first 4 consecutive calendar
quarters.
iii. Reducing the Rebate Amount for Part
B Rebatable Biosimilar Biological
Products When There Is a Severe
Supply Chain Disruption
In § 427.402 of this proposed rule,
CMS proposes to codify the policy
established in section 50.12 of the
revised Medicare Part B Drug Inflation
Rebate Guidance for rebate reductions
when CMS determines there is a severe
supply chain disruption during a
calendar quarter. As proposed in
§ 427.402(b)(1), CMS would provide a
time-limited standard reduction of 75
percent in the total rebate amount for a
Part B rebatable biosimilar biological
product when CMS determines there is
a severe supply chain disruption during
the calendar quarter, such as that caused
by a natural disaster or other unique or
unexpected event. To receive a rebate
reduction in accordance with proposed
§ 427.402(b)(1), the manufacturer would
have to submit to CMS a rebate
reduction request 576 that meets the
eligibility requirements in proposed
§ 427.402(c). A rebate reduction request
should specify each NDC–11 and
HCPCS code to which the request
applies and if CMS grants a
manufacturer’s request for an NDC–11,
CMS proposes in § 427.402(b)(3) that the
rebate reduction would apply to all the
NDC–11s under the relevant HCPCS
code. CMS has proposed additional
576 The rebate reduction request forms are
currently going through the Paperwork Reduction
Act approval process under the document identifier
CMS–10858. The proposed collection was
published for a 30-day comment period in the June
3, 2024 Federal Register (89 FR 47563).
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submission requirements for rebate
reduction requests in the information
collection request under OMB control
number: 0938–NEW (CMS–10858).
As proposed in § 427.402(c)(4), CMS
would grant a reduction in the rebate
amount owed if a manufacturer of an
eligible drug submits to CMS a request
in writing demonstrating supply chain
disruption has occurred during the
calendar quarter, (2) the severe supply
chain disruption directly affects the
manufacturer itself, a supplier of an
ingredient or packaging, a contract
manufacturer,577 or a method of
shipping or distribution that the
manufacturer uses in a significant
capacity to make or distribute the Part
B rebatable biosimilar biological
product, and (3) the severe supply chain
disruption was caused by a natural
disaster or other unique or unexpected
event. As proposed in § 427.402(c)(2),
for a natural disaster or other unique or
unexpected event occurring on or after
August 2, 2024, that the manufacturer
believes caused a severe supply chain
disruption, the manufacturer must
submit the rebate reduction request
within 60 calendar days from the first
day that the natural disaster or other
unique or unexpected event occurred or
began in order for CMS to consider a
rebate reduction.
CMS believes that severe supply
chain disruptions generally take time to
resolve and for purposes of this
proposed rule, CMS proposes in
§ 427.402(a) to codify the policy
established in section 50.12 of the
revised Medicare Part B Drug Inflation
Rebate Guidance whereby a
determination that a severe supply
chain disruption has occurred would be
deemed to disrupt the supply chain for
the quarter in which the event occurred
and the three subsequent calendar
quarters. If the manufacturer makes a
timely request that includes all the
supporting documentation and CMS
determines, based on its review of the
reduction request and supporting
documentation, that a reduction should
be granted, CMS would reduce the total
rebate amount owed by a manufacturer
by 75 percent for the calendar quarter in
which the event that caused the severe
supply chain disruption occurred or
began, or the following calendar quarter
if the request is submitted less than 60
577 A contract manufacturer is a party that
performs one or more manufacturing operations on
behalf of a manufacturer(s) of active pharmaceutical
ingredients (APIs), drug substances, in-process
materials, finished drug products, including
biological products, and combination products. See
‘‘Contract Manufacturing Arrangements for Drugs:
Quality Agreements Guidance for Industry,’’
November 2016: https://www.fda.gov/media/86193/
download.
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calendar days before the end of a
calendar quarter, and the three calendar
quarters thereafter.
CMS proposes in § 427.402(c)(5) that
if the manufacturer believes a severe
supply chain disruption continues into
a fifth consecutive calendar quarter after
the start of the natural disaster or other
unique or unexpected event, the
manufacturer may request a reduction of
the rebate amount for the fifth through
eighth calendar quarters by submitting a
rebate reduction extension request to
CMS along with any new supporting
documentation. CMS has proposed
additional submission requirements for
rebate reduction extension requests in
the information collection request under
OMB control number: 0938–NEW
(CMS–10858). As proposed in
§ 427.402(c)(5)(ii), a rebate reduction
extension request and any new
supporting documentation must be
submitted at least 60 calendar days
before the start of the fifth calendar
quarter in order for CMS to consider a
rebate reduction extension.
If the manufacturer submits a
complete and timely extension request,
and CMS determines that the
information submitted warrants an
extension of the rebate reduction, the
total rebate amount would be reduced
by 75 percent for the fifth through
eighth calendar quarters for that
manufacturer’s Part B rebatable
biosimilar biological product, in
accordance with proposed
§ 427.402(b)(2).
Consistent with the policy established
in section 50.12 of the revised Medicare
Part B Drug Inflation Rebate Guidance,
a manufacturer may receive only one
extension of the rebate reduction per
Part B rebatable biosimilar biological
product per CMS determination of a
severe supply chain disruption, as
proposed in § 427.402(c)(5). Said
differently, the severe supply chain
disruption rebate reduction would be
limited to 8 consecutive calendar
quarters total per Part B rebatable
biosimilar biological product per CMS
determination of a severe supply chain
disruption.
As proposed in § 427.402(b)(4)(i), if
the manufacturer believes there are
multiple events causing severe supply
chain disruptions during the same four
calendar quarters for the same Part B
rebatable biosimilar biological product
and submits multiple rebate reduction
requests for the same product, CMS will
grant no more than one rebate reduction
for that Part B rebatable biosimilar
biological product for those 4
consecutive calendar quarters. For
example, if the manufacturer of a Part B
rebatable biosimilar biological product
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61953
is granted a severe supply chain
disruption rebate reduction request for
its product due to a natural disaster that
occurred in January 2025 and then
experiences a second severe supply
chain disruption caused by a second,
distinct natural disaster in July 2025,
CMS would not grant the second rebate
reduction request. That is, the
manufacturer would receive the 75
percent reduction for four calendar
quarters for the severe supply chain
disruption caused by the first natural
disaster but would not receive a
reduction for the second natural
disaster. However, if the second natural
disaster exacerbated the severe supply
chain disruption caused by the first
natural disaster, the manufacturer may
reflect such circumstances in its request
for an extension of the rebate reduction
for the fifth through eighth calendar
quarters.
As proposed in § 427.402(b)(4)(ii), if
CMS grants a severe supply chain
disruption rebate reduction request for a
Part B rebatable biosimilar biological
product, and the product appears as
currently in shortage during one of the
same four calendar quarter(s) as for
which the severe supply chain
disruption reduction was granted, CMS
would apply the 75 percent reduction to
the four calendar quarters for which the
severe supply disruption request was
granted and would not grant any
additional reduction for the shortage
status during those quarters. For any
subsequent calendar quarters that the
Part B rebatable biosimilar biological
product appears as currently in
shortage, CMS would reduce the rebate
amount in accordance with the drug
shortages reduction proposed in
§ 427.401, starting with the highest
reduction (that is, 75 percent for a
plasma-derived product and 25 percent
for a Part B rebatable drug that is not a
plasma-derived product). For example,
if CMS grants a severe supply chain
disruption rebate reduction request for a
Part B rebatable biosimilar biological
product that was submitted on February
15, 2024, and that product is currently
in shortage from December 15, 2024
until May 15, 2025, CMS would apply
a 75 percent reduction in the total rebate
amount to all four calendar quarters in
2024, and then would apply the
shortages reduction as proposed in
§ 427.401, beginning with a reduction of
25 percent for a Part B rebatable
biosimilar biological product or 75
percent in the case of a plasma-derived
product that is a Part B rebatable
biosimilar biological product for the
first two calendar quarters of 2025.
As proposed in § 427.402(b)(4)(iii), if
a Part B rebatable biosimilar biological
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product that is currently in shortage
experiences a severe supply chain
disruption, the manufacturer may
submit a request for a severe supply
chain disruption rebate reduction. If
CMS grants the rebate reduction request,
the rebate amount would be reduced by
75 percent for the duration of 4
consecutive calendar quarters (that is,
the calendar quarter in which the event
that caused the severe supply chain
disruption occurred and the three
calendar quarters thereafter), and CMS
would not grant any additional
reduction under § 427.401 for the
currently in shortage status during those
4 calendar quarters. If CMS receives the
request and all supporting
documentation describing the natural
disaster or other unique or unexpected
event causing the severe supply chain
disruption less than 60 days before the
end of a calendar quarter, CMS would
apply the 75 percent rebate reduction to
the next calendar quarter and to the
three subsequent calendar quarters
thereafter. For example, if a Part B
rebatable biosimilar biological product
that is currently in shortage in the
calendar quarter beginning October 1,
2024, is granted a severe supply chain
disruption rebate reduction request as a
result of a natural disaster that occurs
on October 20, 2024, CMS would apply
a 75 percent reduction in the rebate
amount for the duration of the calendar
quarter in which the natural disaster
occurred and the three subsequent
calendar quarters thereafter (that is,
October 1, 2024, to September 30, 2025).
In this same example, if the natural
disaster instead occurs on November 20,
2024, CMS would apply the shortages
reduction proposed in § 427.401 for the
calendar quarter beginning October 1,
2024, and ending on December 31, 2024,
and then a 75 percent reduction under
the severe supply chain disruptions
policy to the next calendar quarter and
the three subsequent calendar quarters
thereafter (that is, January 1, 2025 to
December 31, 2025).
In proposed § 427.402(c)(6), CMS
proposes to review rebate reduction
requests and rebate reduction extension
requests within 60 calendar days of
receipt of all documentation, if feasible,
beginning with the calendar quarter that
begins on October 1, 2024. CMS will
begin accepting rebate reduction
requests and rebate reduction extension
requests upon completion of the
Paperwork Reduction Act (PRA)
process, including for severe supply
chain disruptions caused by a natural
disaster or other unique or unexpected
event that occurred on or after January
1, 2023, prior to completion of the PRA
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process. If a manufacturer’s rebate
reduction request does not meet the
criteria in proposed § 427.402(c)(4) or if
the rebate reduction request is
incomplete or untimely based on the
requirements in proposed § 427.402(c),
CMS would deny the request. CMS also
proposes that if a manufacturer’s rebate
reduction extension request does not
meet the criteria in proposed
§ 427.402(c)(5), is incomplete or
untimely based on the requirements in
proposed § 427.402(c)(5), or if a
reduction under proposed
§ 427.402(b)(1) was not provided for
such Part B rebatable biosimilar
biological product, CMS would deny the
rebate reduction extension request. As
proposed in § 427.402(c)(6)(iii), CMS’
decisions to deny a request would be
final and not be subject to an appeals
process.
As proposed at § 427.402(c)(7), CMS
would keep confidential, to the extent
allowable under law, any requests for a
rebate reduction, including supporting
documentation. CMS proposes that
information provided as part of a severe
supply chain disruption rebate
reduction request that the submitter
indicates is a trade secret or confidential
commercial or financial information
would be protected from disclosure if
CMS determines the information meets
the requirements set forth under
Exemptions 3 and/or 4 of the Freedom
of Information Act (FOIA). In addition
to the protections under the FOIA for
trade secrets and commercial or
financial information obtained from a
person that is privileged or confidential,
the Trade Secrets Act at 18 U.S.C. 1905
requires executive branch employees to
protect such information. CMS would
protect confidential and proprietary
information as required by applicable
law.
f. Reports of Rebate Amounts,
Reconciliation, Suggestion of Error, and
Payments (§§ 427.500 Through 427.505)
Section 1847A(i)(1)(A) of the Act
requires the Secretary to provide a
report to each manufacturer of a Part B
rebatable drug with the following
information not later than 6 months
after the end of an applicable calendar
quarter: (1) the total number of billing
units for each Part B rebatable drug; (2)
the amount, if any, of the excess average
sales price increase (the amount by
which the specified amount exceeds the
inflation-adjusted payment amount as
calculated in proposed § 427.301(g)) for
an applicable calendar quarter; and (3)
the rebate amount for the Part B
rebatable drug. In compliance with
section 1847A(i)(1)(B) of the Act,
manufacturers of a Part B rebatable drug
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must provide a rebate for each Part B
rebatable drug no later than 30 calendar
days after the receipt of the information
provided by the Secretary in section
1847A(i)(1)(A) of the Act.
To fulfill this statutory requirement,
CMS is proposing to provide a
Preliminary Rebate Report followed by
a Rebate Report, as described in
proposed § 427.501(b) and (c), to all
manufacturers of a Part B rebatable
drug, even if the amount due is $0; all
rebate amounts would be subject to
reconciliation as proposed in
§ 427.501(d). As proposed in
§ 427.501(d)(4), CMS does not intend to
send notice to manufacturers for drugs
that are not considered rebatable
pursuant to proposed § 427.20.
Additionally, to address the
completeness and accuracy of the rebate
amount, CMS proposes to conduct one
regular reconciliation to determine
whether the rebate amount should be
adjusted due to updated claims and
payment data used in the calculation of
such rebate amount (specified in
proposed § 427.501(b)(1)) to occur 12
months after the issuance of the Rebate
Report. The reporting process for
reconciliation will be the same process
described for the original Rebate Report,
with payment due for any outstanding
rebate amount 30 days after receipt of a
report with a reconciled rebate amount.
In addition to regular reconciliation,
CMS proposes a process to conduct
reconciliation of the rebate amount as
needed to correct agency error and
when CMS determines that the
information used by CMS to calculate a
rebate amount was inaccurate due to
manufacturer misreporting.
CMS believes conducting a
reconciliation for the Part B Rebate
Program is important in ensuring the
accuracy of the rebate amount and for
programmatic alignment with the Part D
Rebate Program.
i. Definitions
In proposed § 427.500, CMS proposes
the following term applicable to
proposed subpart F (§§ 427.500 through
427.505):
• ‘‘Date of receipt’’.
For example, if CMS issues a Rebate
Report through the method and process
described in § 427.504 on June 30, 2026,
then July 1, 2026, will be the date of
receipt and day one of the 30-calendarday payment period.
ii. Reports of Rebate Amounts and
Suggestion of Error
Consistent with the process specified
in section 60 of the revised Medicare
Part B Drug Inflation Rebate Guidance
involving preliminary and final reports,
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CMS proposes to codify a multi-step
process to provide a manufacturer as
defined in § 427.20 with the rebate
information specified in section
1847A(i)(1)(A) of the Act. CMS
considered the following factors in
determining a method and process for
providing the rebate information:
meeting statutorily provided deadlines
in section 1847A(i) of the Act (for
example, dates by which to provide the
rebate amount to the manufacturer); the
operational time to acquire the relevant
information specified in the proposed
part 427; the operational time to
calculate the rebate amount specified in
subpart D of the proposed part 427;
clarity of the information provided as
well as potential burden on
manufacturers; and how to ensure
accuracy of the rebate amount.
CMS proposes at proposed § 427.501
the use of an initial Preliminary Rebate
Report and a subsequent Rebate Report,
with an opportunity for manufacturers
to identify certain mathematical errors
(see proposed § 427.503 and discussed
in further detail later in this section)
and one regular reconciliation of the
rebate amount to account for data
revisions 12 months after the Rebate
Report is provided. CMS proposes at
proposed § 427.501(d)(1), to conduct a
reconciliation 12 months after issuance
of the subsequent Rebate Report
specified in § 427.501(c) to include any
restatements that have occurred in the
drug pricing data and claims billing data
reported to CMS and used in the rebate
calculation specified in subpart D of the
part.
CMS proposes in proposed § 427.501
that the multi-step reporting process for
providing rebate information to a
manufacturer would include: (1) an
initial report, which CMS proposes to
entitle the ‘‘Preliminary Rebate Report’’
in proposed § 427.501(b) and (2) a
second report, which CMS proposes to
entitle the ‘‘Rebate Report’’ in proposed
§ 427.501(c). The Rebate Report would
serve as the invoice for the rebate
amount due, if any, for each NDC that
has been assigned to a billing and
payment code for a product determined
to be a Part B rebatable drug for the
applicable calendar quarter, as specified
in proposed § 427.101. Manufacturers of
Part B rebatable drugs would receive a
Rebate Report for their rebatable drugs
even if the amount due is $0. CMS
proposes at proposed § 427.501(d)(1) a
regular reconciliation of the rebate
amount to occur 12 months after
issuance of the subsequent Rebate
Report specified in proposed
§ 427.501(c).
As the first step in the reporting
process, as proposed in proposed
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§ 427.501(b) and consistent with section
60 of the revised Medicare Part B Drug
Inflation Rebate Guidance, CMS would
provide the manufacturer of a Part B
rebatable drug with the preliminary
rebate amount through a Preliminary
Rebate Report that is provided to each
manufacturer of a Part B rebatable drug
at least 1 month prior to the issuance of
the Rebate Report specified in proposed
§ 427.501(c) for an applicable calendar
quarter (that is, at least 5 months after
the end of the applicable calendar
quarter). To facilitate manufacturer
understanding of the Preliminary Rebate
Report, CMS is proposing in proposed
§ 427.501(b)(1) that the Preliminary
Rebate Report would include the
following information: the NDC(s) and
billing and payment code for the Part B
rebatable drug as specified in proposed
§ 427.20, the total number of billing
units as specified in proposed § 427.303;
the payment amount in the payment
amount benchmark quarter as specified
in proposed § 427.302(d); the applicable
calendar quarter specified amount as
specified in proposed § 427.302(b); the
applicable benchmark period and rebate
period CPI-Us as specified in proposed
§ 427.302(e) and (f); the inflationadjusted payment amount as specified
in proposed § 427.302(g); the amount, if
any, by which the specified amount as
described in proposed § 427.302(b)
exceeds the inflation-adjusted payment
amount as described in proposed
§ 427.302(g) for the Part B rebatable drug
for the applicable calendar quarter as
determined under proposed § 427.302;
any applied reduction as described in
proposed §§ 427.401 and 427.402; and
the rebate amount due as specified in
proposed § 427.301(a).
When determining what information
should be included on rebate reports,
CMS considered the statutory
requirements outlined in section
1847A(i)(1)(A) of the Act to determine
which data elements are necessary to
review the Preliminary Rebate Report
for error (described later in this section)
and to protect proprietary information.
In response to comments on the initial
Medicare Part B Drug Inflation Rebate
Guidance, CMS has proposed to
disclose data elements as suggested by
interested parties that are not
enumerated in the statute, such as the
applicable benchmark period and rebate
period CPI-Us. CMS acknowledges
requests from interested parties to
provide additional data elements such
as claims-level data at the NDC–11
level, that are not included in this
proposal. CMS considered these
requests in development of this
proposed rule but does not believe it
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61955
necessary to provide further information
to fulfill its statutory obligation and
believes that the potential benefit to
manufacturers of additional data are
outweighed by the administrative
burdens additional reporting would
impose to the agency. The elements
listed above provide sufficient
information for a manufacturer review
the Preliminary Rebate Report for
mathematical error, while protecting
proprietary information, and these
elements are operationally feasible for
CMS to provide. CMS believes the
elements listed in proposed
§ 427.501(b)(1) satisfy these
considerations.
By structuring the Rebate Report
process to include a Preliminary Rebate
Report before the Rebate Report, CMS is
able to provide manufacturers with an
opportunity to review the Preliminary
Rebate Report before the rebate amount
is invoiced via the Rebate Report. While
CMS is not required to provide a
preliminary report, CMS seeks to
facilitate manufacturer understanding of
the report and believes it would be
beneficial for manufacturers to review
the report for mathematical errors that
can be corrected before invoicing via the
Rebate Report. Further, a Preliminary
Rebate Report would provide additional
notice to manufacturers regarding
whether they may owe a rebate amount.
In proposed § 427.503, CMS proposes
a process in which a manufacturer may
suggest to CMS that the manufacturer
believes the Preliminary Rebate Report
includes a mathematical error within 10
calendar days after the date of receipt of
the Preliminary Rebate Report. For
example, if the Preliminary Rebate
Report is provided on May 31, 2026,
then June 1, 2026, would be the date of
receipt and, therefore, day one of the 10calendar-day period to submit a
Suggestion of Error. In this example,
Suggestions of Error would be due by
11:59 p.m. PT on June 10, 2026. CMS
reviewed comments on the 10-day
Suggestion of Error period submitted in
response to the initial Medicare Part B
Drug Inflation Rebate Guidance, many
of which suggested that manufacturers
receive at least 30 days to review the
Preliminary Rebate Report. CMS
considered a 10-day, 15-day, and 30-day
Suggestion of Error period and believes
a 10-calendar-day period (see proposed
§ 427.503(c)) is sufficient after
considering the volume of the data to be
provided to manufacturers, the narrow
scope of items that may be identified as
a Suggestion of Error, and the
operational time necessary for CMS to
provide a Rebate Report within 6
months of the end of the applicable
calendar quarter as required under
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section 1847A(i)(1)(A) of the Act.
However, CMS proposes in proposed
§ 427.502(c)(1)(ii) to expand the
Suggestion of Error period to 30
calendar days for the Preliminary Rebate
Report for calendar year 2023 and
calendar year 2024. This extended
Suggestion of Error period will provide
additional time and flexibility during
the first invoicing cycle of the Part B
Rebate Program.
Section 1847A(i)(8) of the Act
precludes administrative or judicial
review on the determination of units,
whether a drug is a Part B rebatable
drug, and the calculation of the rebate
amount (see proposed § 427.503(a)(1)).
Therefore, the Suggestion of Error
process will be limited to mathematical
steps involved in determining the rebate
amount and the elements precluded
from administrative or judicial review
will not be considered in-scope for the
Suggestion of Error process.
Additionally, CMS is not providing an
administrative dispute resolution
process. CMS intends to consider all inscope submissions under the Suggestion
of Error process as specified in proposed
§ 427.503(a) (for example, suggestions
regarding a mathematical error). CMS
does not intend to review suggestions of
error that are out-of-scope or
submissions for a rebatable drug with an
amount due of $0.
As the second step in the reporting
process, CMS proposes in proposed
§ 427.501(c) to provide the rebate
amount to the manufacturer through the
Rebate Report no later than 6 months
after the end of the applicable calendar
quarter. As proposed in § 427.501(c)(1),
the Rebate Report would include the
same data elements as the Preliminary
Rebate Report (specified in
§ 427.501(b)(1)) and include any
recalculations based on CMS acceptance
of a manufacturer’s Suggestion of Error
from proposed § 427.503, or any CMSdetermined recalculations from
proposed § 427.501(d)(2), if applicable.
Manufacturers must pay the rebate
amount within 30 calendar days from
the date of receipt of the Rebate Report
(see proposed § 427.505(a)). For
example, if the Rebate Report is
provided on June 30, 2026, then July 1,
2026, would be the date of receipt and
therefore day one of the 30-calendar-day
payment period; payment would be due
no later than 11:59 p.m. PT on July 30,
2026.
In proposed §§ 427.504 and 427.505,
CMS proposes that it will establish a
standard method and process to issue
Rebate Reports and accept manufacturer
rebate payments. This method and
process may include an online portal
administered by a CMS contractor
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which would provide manufacturers
with access to their Rebate Reports,
submit Suggestions of Error, and pay a
rebate amount due. CMS intends to
provide technical instructions separate
from this rulemaking to manufacturers
of Part B rebatable drugs regarding how
to access Rebate Reports and how to
receive notifications alerting the
manufacturer when information is
available. CMS also intends to issue
reminder notices to manufacturers
regarding the due date of rebate
payments. In proposed § 427.504(a),
CMS notes that the manufacturer that
may access Rebate Reports and make
applicable rebate amount payments is
the manufacturer responsible for paying
a rebate and, as stated above, CMS
proposes to identify the manufacturer
that is responsible for paying a rebate
using the same approach used for
reporting ASP and Medicaid Drug
Rebate Program data.
iii. Reconciliation of a Rebate Amount
As discussed in section 60 of the
revised Medicare Part B Drug Inflation
Rebate Guidance, CMS considered
options for establishing a standardized
method and process at regular intervals
to determinate any appropriate
adjustments to the rebate amount for a
Part B rebatable drug for an applicable
calendar quarter to account for revised
information as well as options for
recalculation based on CMS identifying
an agency error or determining
manufacturer data was misreported.
While the provisions in 1847A(i) of the
Act do not expressly provide for
reconciliation in the Medicare Part B
Drug Inflation Rebate Program, CMS has
determined that a process for
reconciling the rebate amount for
updated information is necessary and
appropriate to promote the accuracy of
the rebate amount for each drug for each
applicable calendar quarter. CMS is
proposing policies for reconciliation,
including with respect to enforcement
of payment of any reconciled rebate
amount, consistent with both the
statutory framework for the Part B
Inflation Rebate Program and the
express authority in sections 1102 and
1871 of the Act to adopt regulations for
the proper administration of the
Medicare Prescription Drug Inflation
Rebate Program.
As proposed at § 427.501(d), CMS
believes that it is necessary and
appropriate for CMS to recalculate the
rebate amount for an applicable
calendar quarter at a regular interval to
include updated information about key
data elements included in the
calculation of the rebate amount. These
data elements as set forth in proposed
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§ 427.501(d)(1)(i) include: total units;
the payment amount in the payment
amount quarter; and any applied
reductions as described in proposed
§§ 427.401 and 427.402. Updating these
calculation inputs at a regular
reconciliation interval will result in a
rebate amount that more fully reflects
the majority of shifts in the underlying
data following additional time for
claims run-out, which refers to the
maturation of claims in the claims
processing system. Because the
information accessed represents the
claims’ status in the claims processing
system at that moment in time,
additional claims run-out may yield
different information, either because
more claims with dates of service during
the applicable calendar quarter were
finalized and added to the claims
processing system or because the status
of the existing claims changed. CMS
refers to ‘‘X months of run-out’’ as the
period between the end of the
applicable calendar quarter and the date
when CMS accesses information about
the claims; for example, ‘‘3 months of
run-out’’ means that claims data are
accessed for claims with service dates
during an applicable calendar quarter 3
months after the end of such applicable
calendar quarter. Conducting a
reconciliation of the rebate amount with
additional claims run-out will improve
the accuracy of the rebate amount.
Additionally, reconciliation of payment
amounts is consistent with the approach
to the calculation of payment amounts
in other CMS programs (such as the
Coverage Gap Discount Program) that
provide for a reconciliation period.
CMS notes that the reconciliation of a
rebate amount, whether the regular
reconciliation proposed at
§ 427.501(d)(1) or a discretionary
reconciliation proposed at
§ 427.501(d)(2) discussed further below,
will not create a separately payable and
distinct rebate amount. Rather,
reconciliation updates the prior rebate
amount owed to CMS, if any, by a
manufacturer of a Part B rebatable drug
so that the rebate amount ultimately
reflects a more precise calculation of the
rebate amount, as required by section
1847A(i) of the Act, to account for shifts
in the underlying data following
additional time for claims run-out after
the Rebate Report is issued as well as
subsequently identified data integrity
issues. Moreover, because the
reconciled rebate amount is an
adjustment to the prior rebate amount,
CMS proposes at § 427.501(d)(1)(i)(F) for
the report of a reconciled rebate amount
to also identify the difference between
the rebate amount due as specified on
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the Rebate Report set forth in
§ 427.501(c) and the reconciled rebate
amount. CMS would only collect the net
rebate amount due, if any, upon
reconciliation, so as to prevent any
duplicate payments. CMS also proposes
to refund any overpayment made by a
manufacturer, as determined during
reconciliation, as discussed in proposed
§ 427.505(c).
Additionally, as CMS suggested in
section 60 of the revised Medicare Part
B Drug Inflation Rebate Guidance, CMS
considered multiple options for
establishing a standardized method and
process to occur at regular intervals to
determine any appropriate adjustment
to the rebate amount for a Part B
rebatable drug for an applicable
calendar quarter to account for revised
information prior to adopting the
proposal described here with for
reconciliation of the Part B inflation
rebate amount at 12 months. CMS
considerations included the length of
time needed to capture relevant changes
to data inputs for recalculation, whether
the timing should align with the
reconciliation of Part D rebate amounts,
and manufacturer burden. Specifically,
CMS considered the average time span
needed to ensure submission of the
majority of revisions from claims runout periods for Part B,578 and how such
unit revisions compare to the Part D
plan unit revisions specified in section
1860D–14B(b)(6) of the Act. CMS also
considered the average time span
needed to ensure the majority of Part B
claims submitted would already be
adjudicated and determined to be final
action claims, CMS’ policies related to
the frequency of ASP restatements, the
reporting timeline for refunds on
discarded drug units, and reporting
timelines for 340B claims and claims for
beneficiaries dually eligible for
Medicare and Medicaid. Without a
reconciliation process, the Part B rebate
amount would include units of
discarded drugs on which
manufacturers potentially owe a refund,
thereby potentially requiring
manufacturers to pay both a discarded
drug refund and a rebate amount on
certain units of a Part B rebatable drug
due to the timing of revisions to
discarded drug units discussed in
further detail in section II.2.c.iv of this
proposed rule.
CMS believes a longer period of
claims run-out (at least 12 months of
run-out time in the proposed approach)
would ensure that CMS more fully
accounts for capturing of revised units.
578 See the CCW White Paper: Medicare Claims
Maturity, https://www2.ccwdata.org/documents/
10280/19002256/medicare-claims-maturity.pdf.
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CMS considered that penalties
associated with failure to submit timely
and accurate ASP data (specified in
§ 414.806(b)) encourage timely
submission of ASP data with the
submission timeline in accordance with
§ 414.804(a)(5) when considering the
completeness of 12 months of claims
run-out. While CMS considered a longer
period until a revision is completed,
such as the 36-month period provided
by the Medicaid Drug Rebate Program
(MDRP) for AMP restatements in
§ 447.510(d)(3), CMS believes that a 12month reconciliation period is
appropriate for the Part B rebate
program because of requirements to
submit timely and accurate ASP data
(specified in § 414.806(b)), and it
provides sufficient time to capture the
majority of updates to the data specified
in proposed § 427.301 while closing out
(except for the proposed circumstances
in proposed § 427.501(d)(2) regarding
CMS’ identification of mathematical
errors or manufacturer misreporting) the
calculation of the rebate amount for a
Part B rebatable drug for an applicable
calendar quarter within a reasonable
time period after the Rebate Report is
issued. While CMS proposes a 12- and
36-month reconciliation period in the
Medicare Part D Drug Inflation Rebate
Program, due largely to the 36-month
restatement period provided for MDRP
AMP restatements (specified in
§ 447.510(d)(3)), CMS does not believe a
second or longer restatement process is
needed for Part B rebatable drugs
because, as described previously, the
ASP and claims run-out periods
correspond with sufficient claims runout and ASP restatement timing for Part
B (particularly when considering
penalties associated with failure to
submit timely and accurate ASP data
(specified in § 414.806(b)).
Further, in considering whether
consistency across CMS programs is
critical, CMS believes that consideration
for the completeness of data, as
discussed above, should be prioritized
over consistency across program
timelines. That is, when examining
timelines from other CMS programs that
collect data contributing to calculation
of the rebate amount, CMS prioritized
that, to the extent feasible, completeness
and accuracy of the data elements
contributing to the calculation of the
rebate amount rather than prioritizing
consistency among the data collection
and reconciliation timelines themselves.
Finally, CMS believes that a restatement
of each data element included in
proposed § 427.501(d) to reconcile the
rebate amount provided in the Rebate
Report in proposed § 427.501(c) and
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61957
drugs acquired through the 340B
Program as proposed in
§ 427.303(b)(1)(i) is appropriate to
capture an updated rebate amount and
is in line with other CMS programs that
provide for a reconciliation period,
including ASP restatements (see
§ 414.806). While some data points may
not change, CMS would review the data
to determine if there are any updates in
the data and use the updated data in the
reconciliation to provide a reconciled
rebate amount to the manufacturer.
Based on these considerations, similar
to the multi-step process for the Rebate
Report proposed in § 427.501(b) and (c),
in summary, CMS proposes a multi-step
process to provide each manufacturer of
a Part B rebatable drug with a reconciled
rebate amount on a regular basis. At the
12 month reconciliation, CMS proposes
a reconciliation process will include: (1)
a preliminary reconciliation of the
rebate amount, which CMS would
provide to manufacturers of Part B
rebatable drugs as proposed in
§ 427.501(d)(1) and (2) a reconciled
rebate amount, which CMS would
provide to manufacturers of a Part B
rebatable drug as proposed in
§ 427.501(d)(1)(ii). CMS also proposes to
apply the Suggestion of Error process
specified in proposed § 427.503 to the
preliminary reconciliation.
In detail, first, as specified in
proposed § 427.501(d)(1) and similar to
the Preliminary Rebate Report process
proposed in § 427.501(b), CMS proposes
to provide the manufacturer with
information about the preliminary
reconciliation of the rebate amount at
least 1 month prior to the issuance of
the reconciled rebate amount (see
proposed § 427.501(d)(1)) to each
manufacturer of a Part B rebatable drug
for an applicable calendar quarter. CMS
proposes in § 427.501(d)(1) that the
preliminary reconciliation would
include, at a minimum, the same
information outlined for the Rebate
Report and the following updated
information, if applicable: updated total
number of rebatable units as specified in
proposed § 427.303; the payment
amount in the payment amount
benchmark quarter, if any inputs are
restated within the reconciliation runout period, as specified in proposed
§ 427.302(d); applicable calendar
quarter specified amount (defined in
§ 427.302(b)), if any inputs are restated
within the reconciliation run-out
period; the excess amount by which the
specified amount exceeds the inflationadjusted payment amount, if any inputs
are restated within the reconciliation
run-out period, as specified in
§ 427.302; the reconciled total rebate
amount calculated in accordance with
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§ 427.301; and the difference between
the total rebate amount due as specified
on the Rebate Report set forth in
proposed § 427.501(d)(1)(i)).
In proposed § 427.503(a), similar to
the Suggestion of Error process
proposed for the Preliminary Rebate
Report in proposed § 427.501(a), within
10 calendar days after date of receipt of
the information about the preliminary
reconciliation of the rebate amount,
CMS proposes that a manufacturer may
suggest to CMS that the manufacturer
believes the preliminary reconciled
rebate amount contains a mathematical
error. CMS believes a 10-calendar-day
period is sufficient due to the same
considerations of data volume, the
narrow set of reviewable items, and the
operational time period necessary for
CMS to complete the process to publish
the reconciled rebate amount. The
preclusions in section 1847A(i)(8) of the
Act on administrative and judicial
review apply to the reconciliation
process.
Second, in detail, CMS proposes in
§ 427.501(d) to provide the reconciled
rebate amount to the manufacturer 12
months after the Rebate Report was
issued for an applicable calendar
quarter. As proposed in
§ 427.501(d)(1)(i), the information in the
report for the reconciled rebate amount
would include the same data elements
as provided in the information provided
to the manufacturer of a Part B rebatable
drug regarding the preliminary
reconciliation of a rebate amount
(specified in proposed § 427.501(d)(1))
and include any recalculations based on
CMS acceptance of a manufacturer’s
Suggestion of Error from proposed
§ 427.503. A reconciliation of the rebate
amount may result in an increase,
decrease, or no change to the rebate
amount, compared to the Rebate Report
for an applicable calendar quarter (see
proposed § 427.501(d)(3)).
Additionally, as CMS suggested in
section 60 of the revised Medicare Part
B Drug Inflation Rebate Guidance, CMS
considered options for establishing
circumstances where a recalculation of
the rebate amount may be appropriate
for an applicable calendar quarter after
issuing the Rebate Report and/or a
reconciled rebate amount based on CMS
identifying an error or CMS determining
that the information used by CMS to
calculate a rebate amount was
inaccurate due to false reporting or
similar fault by the manufacturer (for
example, manufacturer pricing or
product data under section 1927(b)(3) of
the Act). CMS also considered potential
time limits for revisions and whether
certain circumstances, such as instances
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of false reporting, should be exempt
from such time limits.
Based on these considerations, CMS
believes that, to capture an accurate
rebate amount and consistent with
reconciliations of pricing data otherwise
submitted to CMS that provide for
revisions when necessary due to errors,
including mathematical errors, and
manufacturer misreporting, certain
circumstances may merit a recalculation
of the rebate amount separate from the
12-month reconciliation proposed in
§ 427.501(d)(1). Specifically, CMS
proposes in § 427.501(d)(2) that CMS
may recalculate a rebate amount, when
CMS identifies either: (1) an agency
error such as a mathematical error or an
error in the information specified in a
Rebate Report as described in proposed
§ 427.501(c) or report of a reconciled
rebate amount as described in proposed
§ 427.501(d)(1) including reporting
system or coding errors, or (2) CMS
determining that information used to
calculate the rebate amount was
inaccurate due to manufacturer
misreporting. Examples of agency errors
could include CMS incorrectly
assigning a billing or payment code or
incorrectly calculating the billing units
per package, or the mechanism that
provides a Rebate Report to the
manufacturer or the Rebate Report
incorrectly displays a rebate amount.
Examples of manufacturer misreporting
could include instances in which the
manufacturer has made a correction to
previously submitted data as well as
instances in which the individual or
entity reporting data or information to
CMS on behalf of the manufacturer
knows or should know is inaccurate or
misleading (for example, inaccurate
ASP data as specified in § 414.806). This
does not include standard restatements
to ASP or other data outside of the
standard process of issuing the
reconciled rebate amount. In addition to
manufacturer-initiated corrections, CMS
may become aware of manufacturer
misreporting based on fact finding and
conclusions of enforcement authorities,
for example, the HHS Office of Inspector
General, the CMS Center for Program
Integrity, or the Department of Justice.
In a situation where an error or
manufacturer misreporting is identified
prior to the 12-month reconciliation of
the rebate amount proposed in
§ 427.501(d)(1), CMS may choose to
include a correction based on the
circumstances proposed in
§ 427.501(d)(2) concurrently with the
12-month reconciliation. When CMS
reconciles data due to an instance of
agency error or manufacturer
misreporting, CMS proposes that the
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agency would limit the scope of the
reconciliation to the specific
information that is the basis for the
reconciliation and not update or
otherwise revise any other data
elements in the Rebate Report (specified
in proposed § 427.501(c)) or the report
of the reconciled rebate amount
(specified in proposed § 427.501(d)(1))
unless the correction directly impacts
additional data fields. For example,
CMS believes corrections to an ASP
quarterly file may not change the
specified amount for the applicable
calendar quarter.
In addition, because reconciling a
rebate amount imposes substantial
administrative burden on CMS to
reprocess the rebate amount, retest the
reporting system, and reissue a rebate
report, CMS proposes in § 427.501(d)(2)
that it may exercise discretion not to
initiate recalculate the rebate amount in
these situations which are outside of the
regular reconciliation process proposed
in § 427.501(d)(1).
CMS proposes that for a recalculation
due to agency error, the error must be
identified within 3 years of the date of
receipt of the reconciled rebate amount
for the applicable calendar quarter (see
proposed § 427.501(d)(2)(i)).
Identification means that CMS has
knowledge of the error; CMS does not
need to have completed its revision of
the impacted data or determined if the
revision impacts the rebate amount
within the 3-year period. CMS would
timely complete these steps and
determine, when the reconciliation does
impact the rebate amount, whether the
reconciliation must be included in a
discretionary revision or within an
upcoming reconciled rebate amount for
an applicable calendar quarter. CMS
believes that a 3-year period dating from
the issuance of a reconciliation aligns
broadly with the timeframe in which
most manufacturers provide Part B ASP
restatements.
CMS proposes in § 427.501(d)(2)(ii)
that for a circumstance in which a
manufacturer misreports data, CMS is
not bound by the 3-year time limit for
revision of the rebate amount. For
example, if a determination is made that
a manufacturer misreported ASP data,
then CMS may recalculate the rebate
amount owed for a Part B rebatable
drug. CMS requests comments on the
proposals related to manufacturer
misreporting.
CMS proposes in § 427.505(a)(1) that
upon receipt of the reconciled rebate
amount manufacturers must pay the
rebate within 30 calendar days from the
date of receipt of the reconciled rebate
amount. A 30-day payment deadline
aligns with the payment period set forth
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in statute at section 1847A(i)(1)(B) of the
Act. As specified in proposed § 427.504,
CMS would use the same method and
process for issuing Rebate Reports and
submission of payments for reports with
a reconciled rebate amount. CMS would
provide notice to manufacturers when a
report with a reconciled rebate amount,
which will include the information
proposed in § 427.501(d), is available for
the manufacturer’s Part B rebatable
drugs. CMS proposes in § 427.505(c)
that if a refund is owed to a
manufacturer based on a reconciled
rebate amount, CMS would initiate the
process to issue such a refund within 60
days from the date of receipt of the
reconciled rebate amount (proposed in
§ 427.501(d)). CMS will issue additional
information on this method and process
through additional program
communications.
iv. Rebate Report for Applicable
Calendar Quarters in CY 2023 and CY
2024
Section 1847A(i)(1)(C) of the Act
provides the CMS with the option to
delay sending the information required
by section 1847A(i)(1)(A) for applicable
calendar quarters in calendar years 2023
and 2024 until not later than September
30, 2025. In § 427.502, consistent with
section 60.2 of the revised Medicare Part
B Drug Inflation Rebate Guidance, CMS
proposes consolidating the Preliminary
Rebate Reports and Rebate Reports for
CYs 2023 and 2024 into two reports: one
report for the four applicable calendar
quarters in CY 2023 and one report for
the four applicable calendar quarters in
CY 2024. This approach allows for 12
months of claims run-out for each
applicable calendar quarter in CY 2023
and at least 3 months of claims run-out
for each applicable calendar quarter in
CY 2024. For these combined reports,
CMS proposes in § 427.502 to provide
an extended 30 calendar day Suggestion
of Error period for the Preliminary
Rebate Report.
CMS intends to send a reconciled
rebate amount for the four applicable
calendar quarters in CY 2024 9 months
after the Rebate Report, to allow for 12
months of claims run-out for each
applicable calendar quarter; CMS does
not intend to conduct reconciliation for
the four applicable calendar quarters in
CY 2023 since the Rebate Report would
already reflect 12 months of claims runout (see proposed § 427.502(b)). This
approach aligns claims and payment
data run-out with the run-out used
during a regular reconciliation cycle.
The Suggestion of Error period for the
report containing the reconciled rebate
amount for applicable calendar quarters
in CY 2024 would be 10 calendar days.
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This approach also minimizes the
number of reports issued to
manufacturers as a result of the delay in
reporting and simplifies payment
procedures, thereby minimizing
manufacturer burden. Starting with the
first applicable calendar quarter of CY
2025, reporting would begin a standard
cadence and follow the procedures
otherwise proposed in subpart F of this
part 427.
CMS proposes that manufacturers that
do not pay the Medicare Part B inflation
rebate amount owed for a Part B
rebatable drug within 30 calendar days
of receiving a Rebate Report, including
reports containing a reconciled rebate
amount, may be subject to a civil money
penalty of 125 percent of the rebate
amount, as applicable, for such drug for
the applicable calendar quarter. The
civil money penalty is in addition to the
rebate amount.
g. Enforcement of Manufacturer
Payment of Rebate Amounts (§ 427.600)
Section 1847A(i)(7) of the Act gives
CMS the authority to impose a civil
money penalty equal to at least 125
percent of the rebate amount for each
drug for each applicable calendar
quarter on a manufacturer that fails to
pay the rebate amount for each rebatable
Part B drug. Subpart G would
implement this section of the Act and
establish the procedures for determining
and collecting a civil money penalty.
In accordance with section
1847A(i)(1)(B) and proposed
§ 427.505(a), manufacturers must
provide to CMS a rebate amount owed
within 30 calendar days of receipt of the
Rebate Report containing the rebate
amount due. As described in proposed
§ 427.600(a), CMS is proposing that it
may impose a civil money penalty when
a manufacturer fails to pay the rebate
amount in full by the payment
deadlines proposed in § 427.505(a). This
means a manufacturer may be subject to
a civil money penalty if the
manufacturer fails to pay the full the
rebate amount as invoiced in the Rebate
Report or any reconciled rebate amount
that is greater than the amount invoiced
in the Rebate Report. More specifically,
a manufacturer could be subject to a
civil money penalty when a
manufacturer fails to pay a rebate
amount due by any payment deadline
proposed in § 427.505(a)(1) and (2) for:
(1) a Rebate Report specified in
proposed § 427.501(c); (2) a reconciled
rebate amount greater than the rebate
amount reflected in the Rebate Report
specified in proposed § 427.501(d); or
(3) a Rebate Report and a reconciled
rebate amount greater than the amount
reflected in the Rebate Report, if
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applicable, for the applicable calendar
quarters in calendar years 2023 and
2024 as specified in proposed § 427.502.
As discussed earlier in subpart e.iii,
CMS notes that the reconciled rebate
amount is not a separately payable and
distinct rebate amount. Rather, the
reconciled rebate amount is an update
to the rebate amount owed to CMS by
a manufacturer of a Part B rebatable
drug.
Civil money penalties are a point-intime penalty tied to the rebate amount
due at the applicable payment deadline,
which occurs 30 days after the date of
receipt of a Rebate Report. In proposed
§ 427.600(b), CMS proposes to establish
the methodology for determining the
amount of the civil money penalty as
equal to 125 percent of the rebate
amount for such drug for such
applicable calendar quarter, and that
this penalty would be due in addition
to the rebate amount due. That is, a
manufacturer would be responsible for
paying the full rebate amount due in
addition to any civil money penalty
imposed because of late payment. While
CMS has the statutory authority to
impose a civil money penalty greater
than 125 percent of the rebate amount
in the Part B Rebate Program under
section 1847(A)(i)(7), CMS is proposing
a penalty amount of 125 percent of the
rebate amount to align with the penalty
amount in the Part D Inflation Rebate
Program. CMS is proposing this
approach to civil money penalties based
on section 1847A(i)(1)(B) of the Act,
which establishes a requirement by the
manufacturer to provide CMS with a
rebate not later than 30 days after
receipt from CMS of the report on the
amount of the excess average sales price
increase. CMS believes that the ability
to assess civil money penalties is
necessary in all circumstances where a
payment is due for a rebate amount to
CMS to ensure compliance with the
rebate program’s requirements. The civil
money penalty would be calculated
based on the outstanding rebate amount
due at the payment deadline, which is
defined in proposed § 427.505(a) as 30
calendar days after the date of receipt of
a Rebate Report containing any rebate
amount due; once a civil money penalty
is assessed due to a late payment, the
penalty would remain in effect even if
the manufacturer pays the outstanding
amount as the penalty is initiated due
to a missed payment deadline. Because
the payment deadline is clearly defined
in section 1847A(i)(1)(B) of the Act, any
late payments of a rebate amount due,
including late payment of any
reconciled rebate amounts greater than
the amount reflected in the Rebate
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Report, would be considered a violation
potentially subject to a civil money
penalty. Any civil money penalty would
be assessed before the next
reconciliation process.
CMS is proposing in § 427.600(b)(2)
that civil money penalties may be
calculated at several points in time
associated with missing a payment
deadline for the rebate amount due
reflected in the Rebate Report or missing
a payment deadline associated with any
rebate amount determined after a
reconciliation to be greater than the
amount invoiced in the Rebate Report.
As these separate events can result in
distinct assessments of civil money
penalties, this means that CMS would
not modify a civil money penalty from
a prior missed payment deadline based
on changes to the rebate amount due
following reconciliation, including
scenarios where the rebate amount is
reduced following reconciliation.
However, in the event that the rebate
amount due on a Rebate Report was not
paid and a civil money penalty was
issued for violation of the payment
deadline, CMS would not issue a second
civil money penalty on a reconciled
rebate amount if reconciliation
decreased the rebate amount stated on
the Rebate Report. CMS believes that
enforcing this requirement after each
payment deadline, regardless of what
rebate amount a manufacturer may or
may not owe at a future payment
deadline, is necessary to maintain the
integrity of the program and consistency
of the implementation of the program.
Further, CMS is proposing this
approach to ensure an enforcement
approach that is operationally feasible
and applied consistently in all cases.
As an example of this approach in
practice, CMS presents a scenario where
the rebate amount due on the Rebate
Report is $100. Following reconciliation
12 months after the Rebate Report was
issued, CMS calculates a reconciled
rebate amount for the applicable
calendar quarter of $120 (an increase of
$20 from the rebate amount identified in
the Rebate Report due to updated claims
run-out and payment data). Under this
scenario, in the event the manufacturer
does not pay the $100 rebate amount
owed within the 30-day deadline
following receipt of the Rebate Report,
a civil money penalty for $125 ($100 ×
1.25) could be assessed against the
manufacturer due to their failure to
meet the payment deadline. If the
manufacturer pays the $100 before the
reconciliation is completed, and then
timely pays the $20 due within the 30day payment deadline following the
reconciliation 12 months after the
Rebate Report or does not pay the $100
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before the reconciliation is completed
but timely pays the $120 due within the
30 day payment deadline following
reconciliation 12 months after the
Rebate Report, no further civil money
penalty would be assessed.
Alternatively, in the event the
manufacturer pays the $100 rebate
amount due within the 30-day deadline
following receipt of the Rebate Report
but fails to meet the payment deadline
for the net $20 rebate amount due
following reconciliation, a civil money
penalty of $25 ($20 × 1.25) could be
assessed against the manufacturer due
to their failure to meet the payment
deadline for the updated rebate amount
due following reconciliation. Finally,
under this scenario in the event the
manufacturer fails to meet any payment
deadline throughout the full
reconciliation cycle of this rebate
amount; that is, the deadline is missed
for the $100 amount due stated in the
Rebate Report, and the $20 net rebate
amount due following reconciliation,
CMS may assess a separate civil money
penalty on the rebate amount due at
each of these missed deadlines. In this
example, violations of each of these
payment deadlines would result in a
penalty of $125 ($100 × 1.25), followed
by a penalty of $25 ($20 × 1.25), each
of which would be assessed following
the manufacturer’s failure to meet the
related payment deadline for the
outstanding rebate amount due.
In an alternative possible scenario,
consider the following. The rebate
amount due on the Rebate Report is
$100. Following reconciliation 12
months after the Rebate Report was
issued, CMS calculates a reconciled
rebate amount owed for the applicable
period of $80 (a decrease of $20 from
the rebate amount identified in the
Rebate Report). In this scenario, if a
manufacturer does not pay the $100 by
the payment deadline for the rebate
amount due in the Rebate Report, a civil
money penalty for $125 ($100 × 1.25)
may be assessed against the
manufacturer due to its failure to meet
the payment deadline for the rebate
amount due identified in the Rebate
Report. This civil money penalty is not
affected if the manufacturer pays the
rebate amount once it is past the
deadline, nor is it impacted by the
reconciled rebate amount, because at the
payment deadline missed by the
manufacturer, the manufacturer owed a
rebate of $100 to CMS and that rebate
amount was not paid timely. As noted
previously, under this scenario, given
that there is no additional rebate
amount due upon reconciliation
compared to the rebate amount stated
on the Rebate Report, there would not
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be a civil money penalty assessed on the
reconciled rebate amount.
Further, note that payment of any
civil money penalty does not obviate the
requirement for the manufacturer to pay
any outstanding rebate amount due,
including any rebate amount due
following a reconciliation. Therefore,
paying a civil money penalty does not
satisfy the obligation to pay the
underlying rebate amount on which the
civil money penalty is calculated. In
addition, CMS is evaluating all available
options to ensure manufacturers’ timely
compliance with their rebate payment
obligations, including, without
limitation, potential recovery
approaches and enforcement actions.
For example, CMS may refer
manufacturers to the Department of
Justice, Department of the Treasury,
and/or the Department of Health and
Human Services Office of Inspector
General for further review and
investigation.
In proposed § 427.600(c), CMS
proposes that if CMS makes a
determination to impose a civil money
penalty on a manufacturer for violation
of a payment deadline, CMS would send
a written notice of the decision to
impose a civil money penalty that
includes a description of the basis for
the determination, the basis for the
penalty, the amount of the penalty, the
date the penalty is due, the
manufacturer’s right to a hearing, and
information about where to file the
request for a hearing. To ensure a
consistent approach to civil money
penalties, CMS proposes applying
existing appeal procedures for civil
money penalties in 42 CFR 423, subpart
T of this title to manufacturers
appealing a civil money penalty
imposed under the Medicare Part B
Drug Inflation Rebate Program. CMS has
utilized this appeals process many years
for civil money penalty determinations
affecting MA organizations and Part D
sponsors. CMS therefore proposes to use
this well-established process for civil
money penalty appeals from
manufacturers that do not make
inflation rebate payments by the
payment deadline. CMS also proposes
in § 427.600(e)(1) that the scope of
appeals is limited to: (1) CMS
determinations relating to whether the
rebate payment was made by the
payment deadline; and (2) the
calculation of the penalty amount.
Section 1847A(i)(8) of the Act precludes
judicial review of specific data inputs or
calculations related to the underlying
Rebate Report and reconciliation;
therefore, such data and calculations are
not appealable through this process.
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Section 1847A(i)(7) of the Act states
that the provisions of section 1128A of
the Act (except subsections (a) and (b))
apply to civil money penalties under
this subpart to the same extent that they
apply to a civil money penalty or
procedure under section 1128A(a) of the
Act. CMS proposes to codify this
requirement in proposed § 427.600(f). In
alignment with the procedure outlined
in section 1128A of the Act, CMS
proposes in § 427.600(d) that collection
of the civil money penalty would follow
expiration of the timeframe for
requesting an appeal, which is 60
calendar days from the civil money
penalty determination in cases where
the manufacturer did not request an
appeal. In cases where a manufacturer
requests a hearing and the decision to
impose the civil money penalty is
upheld, CMS would initiate collection
of the civil money penalty once the
administrative decision is final. CMS is
seeking comment on proposals related
to the violations of payment deadlines
and issuance of a civil money penalty.
CMS proposes in § 427.600(g) that in
the event that a manufacturer declares
bankruptcy, as described in title 11 of
the United States Code, and as a result
of the bankruptcy, fails to pay either the
full rebate amount owed or the total
sum of civil money penalties imposed,
the government reserves the right to file
a proof of claim with the bankruptcy
court to recover the unpaid rebate
amount and/or civil monetary penalties
owed by the manufacturer.
h. Severability (§ 427.10)
In proposed § 427.10, we propose
that, were any provision of part 427 to
be held invalid or unenforceable by its
terms, or as applied to any person or
circumstance, such provisions would be
severable from part 427 and the
invalidity or unenforceability would not
affect the remainder thereof or any other
part of this subchapter or the
application of such provision to other
persons not similarly situated or to
other, dissimilar circumstances. While
the provisions in part 427 are intended
to present a comprehensive approach to
implementing the Medicare Part B Drug
Inflation Rebate Program, we intend that
each of them is a distinct, severable
provision, as proposed, and would not
affect similar provisions in the Medicare
Part D Drug Inflation Rebate Program.
Through this rulemaking, the Part B
drug inflation rebate proposals are
intended to operate independently of
each other, even if each serves the same
general purpose or policy goal. For
example, CMS intends that the
proposed policies related to reducing
the rebate amount for Part B rebatable
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drugs currently in shortage and when
there is a severe supply chain
disruption (§§ 427.401 and 427.402) are
distinct and severable from the
proposals related to the determination
of Part B rebatable drugs subject to
rebates (§ 427.101). As another example,
CMS intends that the proposed policy
for using the payment limit for purposes
of calculating the beneficiary
coinsurance adjustment (§ 427.201(b)) is
distinct and severable from the
proposals to use the specified amount
for purposes of the Part B rebate
calculation (§ 427.301). Even where one
provision makes reference to a second
provision, the preamble and the
regulatory text clarify the intent of the
agency that the two provisions would be
severable if one provision were to be
invalidated in whole or in part. For
example, CMS would still be able to
calculate drugs and biological products
with average total allowed charges
below the applicable threshold as
described in § 427.101(c)(1), for
exclusion from inflation rebate
calculations, even if the provision to
apply the applicable threshold at the
billing and payment code level is
deemed invalid (§ 427.101(c)(3)). We
welcome comments on this severability
policy.
3. Medicare Part D Drug Rebates for
Drugs, Biologicals, and Sole Source
Generic Drugs With Prices That Increase
Faster Than the Rate of Inflation
a. Definitions (§ 428.20)
In this proposed rule, CMS proposes
to codify definitions of terms with
meanings given in section 1860D–14B of
the Act and established in the revised
Medicare Part D Drug Inflation Rebate
Guidance, as well as new definitions
based on policies detailed in this
proposed rule.
At proposed § 428.20, CMS is
proposing that the following terms in
section 1860D–14B of the Act are
defined:
• ‘‘Annual manufacturer price
(AnMP)’’.
• ‘‘Applicable period’’.
• ‘‘Applicable period Consumer Price
Index for All Urban Consumers (CPI–
U)’’.
• ‘‘Benchmark period CPI–U’’.
• ‘‘Part D rebatable drug’’.
• ‘‘Payment amount benchmark
period’’.
• ‘‘Unit’’.
Further, in § 428.20 of this proposed
rule, CMS proposes to codify definitions
established in the revised Medicare Part
D Drug Inflation Rebate Guidance and
new definitions based on policies
detailed in this proposed rule for the
following terms:
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• ‘‘Applicable threshold’’.
• ‘‘Average manufacturer price
(AMP)’’.
• ‘‘Benchmark period manufacturer
price’’.
• ‘‘Covered Part D drug’’.
• ‘‘CPI–U’’.579
• ‘‘First marketed date’’.
• ‘‘Inflation-adjusted payment
amount’’.
• ‘‘Manufacturer’’. CMS intends that
manufacturer identification in the
Medicare Prescription Drug Inflation
Rebate Program, inclusive of
communications and rebate liability,
will be consistent with the policies and
practices adopted under § 447.502 for
purposes of manufacturer obligations
under the Medicaid Drug Rebate
Program. We believe this approach will
provide clarity and allow for
consistency in the agency’s treatment of
financial transactions, including in the
contexts of debt collection, bankruptcy,
and changes in ownership. We welcome
feedback on this proposed approach and
whether there are alternative
approaches that may better achieve the
agency’s goals for application of rebate
liability and collection of rebate
amount, including whether additional
policies and/or a Medicare Prescription
Drug Inflation Rebate Program
agreement are needed to clarify
financial accountability for rebate
amounts in situations where there are
changes in ownership of a manufacturer
or of a rebatable drug.
• ‘‘National Drug Code (NDC)’’.
• ‘‘Subsequently approved drug’’.
b. Determination of Part D Rebatable
Drugs (§§ 428.100 Through 428.101)
i. Definitions
In proposed § 428.100, CMS proposes
to define the following terms applicable
to subpart B (§§ 428.100 through
428.101):
• ‘‘Individual who uses such a drug
or biological’’.
• ‘‘Gross covered prescription drug
costs’’.
ii. Identification of Part D Rebatable
Drugs
Section 1860D–14B(g)(1)(A) of the Act
defines a ‘‘Part D rebatable drug,’’ in
part, as a drug or biological described at
section 1860D–14B(g)(1)(C) that is a
‘‘covered Part D drug’’ as that term is
defined in section 1860D–2(e) of the
Act. A drug or biological described in
section 1860D–14B(g)(1)(C) means a
579 These data are referenced to 1982¥84 = 100—
that is, the average of pricing data for the 36 months
from 1982 through 1984 serve as the basis for the
index and are assigned a value of 100. These data
are not seasonally adjusted.
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drug or biological that, as of the first day
of the applicable period involved, is: (1)
a drug approved under an NDA under
section 505(c) of the FD&C Act (that is,
a brand name drug); (2) a drug approved
under an ANDA under section 505(j) of
the FD&C Act that meets the criteria in
section 1860D–14B(g)(1)(C)(ii) (that is, a
generic drug that meets certain sole
source criteria); or (3) a biological
licensed under section 351 of the PHS
Act (that is, a biological product,
including a biosimilar).
In § 428.101(a), CMS proposes to
identify a Part D rebatable drug 580 for
each applicable period by determining
which covered Part D drugs, as defined
in section 1860D–2(e) of the Act, meet
the requirements in section 1860D–
14B(g)(1)(C) of the Act (that is, are brand
name drugs approved under an NDA,
biologicals licensed under a biologics
license application (BLA), or generic
drugs approved under an ANDA). As
noted, a Part D rebatable drug must meet
the requirements in section 1860D–
14B(g)(1)(C) of the Act as of the first day
of the applicable period.
To evaluate whether a generic drug
approved under an ANDA meets all the
criteria in section 1860D–14B(g)(1)(C)(ii)
of the Act, CMS proposes in
§ 428.101(a)(3) to codify the policy
established in section 30 of the revised
Medicare Part D Drug Inflation Rebate
Guidance whereby CMS would use
specified FDA resources such as the
‘‘Approved Drug Products with
Therapeutic Equivalence Evaluations’’
(commonly known as the Orange
Book) 581 and NDC Directory to
determine whether a generic drug meets
the definition of a Part D rebatable drug.
In § 428.101(a)(3)(i) and (ii), CMS
proposes to clarify the policy
established in revised Medicare Part D
Drug Inflation Rebate Guidance by
adding that, for purposes of § 428.101,
CMS considers historical information
from NDC Directory files, such as
discontinued, delisted, and expired
listings, provided by FDA to CMS or
published by FDA on its website to be
included in the NDC Directory. As
proposed in § 428.101(a)(3)(iii), to
determine whether the manufacturer of
the generic drug is a first applicant
during the 180-day exclusivity period,
or whether the manufacturer of the
generic drug is a first approved
580 For purposes of this proposed rule, CMS uses
the term ‘‘Part D rebatable drug’’ to refer to the
dosage form and strength with respect to such drug
for which Part D drug inflation rebates are
calculated.
581 FDA Orange Book: https://www.fda.gov/drugs/
drug-approvals-and-databases/approved-drugproducts-therapeuticequivalence-evaluationsorange-book.
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applicant for a competitive generic drug
therapy, CMS will refer to FDA website
resources such as the Orange Book and
may consult with FDA for technical
assistance as needed. CMS will
determine whether a generic drug that is
a covered Part D drug meets the
definition of a Part D rebatable drug
based on the status of the drug on the
first day of the applicable period.
While generic drugs that do not meet
the sole source criteria in section
1860D–14B(g)(1)(C)(ii) of the Act (that
is, multiple source generic drugs) are
excluded from the definition of a Part D
rebatable drug, CMS understands that a
generic drug may meet the definition of
a Part D rebatable drug on the first day
of an applicable period and then cease
to meet such definition later in the
applicable period if, for example, the
FDA approves another therapeutically
equivalent generic drug under a 505(j)
ANDA and that drug is marketed during
such applicable period.
CMS will use PDE data with gross
covered drug costs greater than zero that
are available for the drug with dates of
service during that applicable period.
Drugs that are determined to have
average annual total costs under Part D
of less than $100 per individual using
such drug per year, adjusted by changes
in the CPI–U, will be excluded from Part
D drug inflation rebate calculations for
the applicable period in question.
iii. Drugs and Biologicals With Average
Annual Total Cost Under Part D Below
the Applicable Threshold
Under section 1860D–14B(g)(1)(B) of
the Act, a drug or biological is excluded
from the definition of a Part D rebatable
drug if the ‘‘average annual total cost’’
under Part D for such period per
individual who uses such a drug or
biological product is less than $100 per
year, as determined by the Secretary
using the most recent data available, or,
if data are not available, as estimated by
the Secretary. The statute provides that
the $100 annual amount for the
applicable period beginning October 1,
2022, is to be increased by percentage
changes in the CPI–U for subsequent
applicable periods. In § 428.101(b), CMS
proposes to codify the policy
established in section 30.2 of the revised
Medicare Part D Drug Inflation Rebate
Guidance for determining the applicable
threshold and excluding from the
definition of a Part D rebatable drug,
and thus Part D drug inflation rebates,
drugs and biologicals for which the
average annual total cost under Part D
for such applicable period per
individual who uses such drug or
biological product is below that
applicable threshold.
As described in the revised Medicare
Part D Drug Inflation Rebate Guidance,
CMS intends to calculate the average
annual total cost based on gross covered
drug costs for the Part D rebatable drug
at the NDC–9 level. CMS will divide the
gross covered drug costs for the drug by
the number of unique Part D
beneficiaries as described above that
were dispensed the drug in that
applicable period. For this calculation,
ii. Calculation of the Total Rebate
Amount To Be Paid by Manufacturers
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c. Determination of the Rebate Amount
for Part D Rebatable Drugs (§§ 428.200
Through 428.204)
i. Definitions
In proposed § 428.200, CMS proposes
to define the following terms applicable
to subpart C (§§ 428.200 through
428.204):
• ‘‘340B Program’’.
• ‘‘Line extension’’.
• ‘‘New formulation’’.
• ‘‘Oral solid dosage form’’.
Under section 1860D–14B(b)(1) of the
Act, the Part D drug inflation rebate for
each Part D rebatable drug and
applicable period, subject to certain
considerations, is the estimated amount
that is equal to the product of: (1) the
amount, if any, by which the annual
manufacturer price (AnMP) for such
Part D rebatable drug for the applicable
period exceeds the inflation-adjusted
payment amount for the Part D rebatable
drug for the applicable period, and (2)
the total number of units of the Part D
rebatable drug dispensed under Part D
and covered and paid by Part D plan
sponsors during the applicable period.
To calculate the Part D drug inflation
rebate consistent with section 1860D–
14B(b)(1) of the Act, CMS proposes in
§ 428.201(a)(1) to codify the calculation
methodology described in section 40 of
the revised Medicare Part D Drug
Inflation Rebate Guidance, which
provides that the total Part D drug
inflation rebate amount is equal to the
per unit Part D drug inflation rebate
amount, as determined under proposed
§ 428.202(a), multiplied by the total
number of units of a Part D rebatable
drug dispensed under Part D and
covered by Part D plan sponsors, as
determined in accordance with
proposed § 428.203. CMS proposes in
§ 428.201(a)(2) that the total Part D drug
inflation rebate amount for a Part D
rebatable drug that is a line extension of
a Part D rebatable drug that is an oral
solid dosage form is equal to the amount
specified in proposed § 428.204. The
Part D drug inflation rebate amount
calculated in accordance with this
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subpart is subject to adjustment based
on any reductions in accordance with
subpart D of this part or any
reconciliations in accordance with
subpart E of the part.
In § 428.201(b), CMS proposes to
exclude from the calculation performed
under subpart C drugs and biologicals
that meet the definition of a Part D
rebatable drug, but which are missing
AMP data for the entire duration of the
applicable period because, for the
reasons specified below, there were no
quarters during that period in which
their manufacturers were required to
report AMP data under section
1927(b)(3) of the Act. The calculations
for the rebate amount set forth in section
1860D–14B(b) of the Act contemplate
use of AMP and unit data reported by
manufacturers under section 1927 of the
Act. Similarly, section 1860D–14B(d) of
the Act indicates CMS should use, for
purposes of carrying out the Medicare
Part D Drug Inflation Rebate Program,
information submitted by manufacturers
under section 1927(b)(3) of the Act.
Section 1927 requires manufacturers
that participate in the Medicaid Drug
Rebate Program (MDRP) to enter into
agreements with the HHS Secretary and
submit price and drug product
information to CMS for each covered
outpatient drug (COD), as defined in
sections 1927(k)(2)–(4) of the Act and in
§ 447.502.
Not every drug that satisfies the
definition of a Part D rebatable drug may
be marketed by a manufacturer that has
an MDRP agreement in effect with the
Secretary during the applicable period.
Similarly, there may be limited
instances in which a drug or biological
satisfies the definition of a Part D
rebatable drug but is not a COD under
the MDRP. As a result, information may
not be reported under section 1927(b)(3)
of the Act for all Part D rebatable drugs,
and thus may not be available to CMS
for purposes of calculating Part D drug
inflation rebates under section 1860D–
14B of the Act. Said differently, in
limited cases where a Part D rebatable
drug is marketed by a manufacturer that
does not have an obligation to report
pricing and drug product data under
section 1927(b)(3) of the Act for the
reasons noted, the manufacturer does
not currently report information needed
for CMS to be able to calculate Part D
drug inflation rebates.
Due to this operational issue, CMS
proposes in § 428.201(b) to codify the
policy established in section 30.1 of the
revised Medicare Part D Drug Inflation
Rebate Guidance whereby CMS would
exclude from Part D drug inflation
rebate calculations drugs and biologicals
that meet the definition of a Part D
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rebatable drug but for which the
manufacturer does not have an MDRP
agreement in effect with the HHS
Secretary under section 1927 of the Act
at any point during the applicable
period, or the Part D rebatable drug is
one that does not meet the definition of
a COD. This would effectively exclude
from rebate calculations Part D rebatable
drugs for which there is missing AMP
data for the entire duration of the
applicable period for the sole reason
that there were no quarters during that
period in which the manufacturer was
required to report AMP data under
section 1927(b)(3) of the Act. In either
of these situations, a manufacturer does
not have an obligation to report pricing
and drug product data under section
1927(b)(3) of the Act and thus the
information required to calculate Part D
drug inflation rebates for these drugs is
not available to CMS. If a manufacturer
is required to report AMP under section
1927(b)(3) of the Act for any part of the
applicable period for a drug or
biological that meets the definition of a
Part D rebatable drug, CMS would not
exclude such drug or biological from
Part D drug inflation rebate calculations.
We also clarify that the proposed
exclusion at § 428.201(b) relates only to
the calculation of the rebate amount and
does not affect the determination of
whether a drug or biological meets the
definition of a Part D rebatable drug.
When performing the reconciliation
described at § 428.401(d), CMS would
reexamine whether the manufacturer
was required to report AMP for any part
of the applicable period for the Part D
rebatable drug; if at reconciliation the
manufacturer was required to report
AMP for any part of the applicable
period, CMS would calculate a Part D
rebate amount for this Part D rebatable
drug. CMS intends to monitor how these
exclusions from the Part D drug
inflation rebate calculation may impact
manufacturer behavior and may revisit
this exclusion in the future.
In the initial Medicare Part D Drug
Inflation Rebate Guidance, CMS
solicited comments on the proposed
approach and alternative approaches.
CMS continues to be interested in
comments on this topic and welcomes
additional comments on this approach
and alternative approaches—
specifically, how CMS should address
the situations in which the
manufacturer of a Part D rebatable drug
does not have an MDRP agreement in
effect for any part of the applicable
period or when a Part D rebatable drug
may be excluded from the definition of
a COD and manufacturers may not be
required to report pricing and drug
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product information under section
1927(b)(3) of the Act.
iii. Calculation of the Per Unit Part D
Drug Rebate Amount
To calculate the total rebate amount
in accordance with proposed
§ 428.201(a), CMS will first calculate the
per unit Part D drug rebate amount as
proposed in § 428.202. As described in
the revised Medicare Part D Drug
Inflation Rebate Guidance and provided
in proposed § 428.202(a), CMS will
calculate the per unit Part D drug
inflation rebate amount by determining
the amount by which the AnMP for a
Part D rebatable drug exceeds the
inflation-adjusted payment amount for
such drug for the applicable period. To
determine the per unit Part D inflation
rebate amount for a Part D rebatable
drug, CMS must calculate the AnMP for
the drug, identify the payment amount
benchmark period and calculate the
benchmark period manufacturer price
for the drug, identify the benchmark
period CPI–U, and calculate the
inflation-adjusted payment amount for
the drug.
(1) Calculation of the AnMP for the
Applicable Period
To determine the AnMP for a Part D
rebatable drug and applicable period,
CMS proposes in § 428.202(b) to codify
the policy described in the revised
Medicare Part D Drug Inflation Rebate
Guidance whereby CMS would use the
AMP reported by a manufacturer to the
Medicaid Drug Programs system under
sections 1927(b)(3)(A)(i) and (ii) of the
Act for each calendar quarter of the
applicable period, as well as the units
reported by a manufacturer under
section 1927(b)(3)(A)(iv) of the Act for
each month of the applicable period.
The manufacturer-reported AMP units
represent the total units of a drug sold
by the manufacturer each month to
retail community pharmacy and
wholesaler purchasers as described
under section 1927(k)(1)(A) of the Act.
Manufacturers may include under
certain circumstances non-retail
community pharmacy sales units in the
calculation of their AMPs for 5i
drugs.582
582 5i drugs are CODs that are inhaled, infused,
instilled, implanted, or injected. Manufacturers are
instructed to calculate the AMP for 5i drugs that are
not generally dispensed through a retail community
pharmacy using the methodology described at
§ 447.504(d) and (e). Section 447.507(b)(1) provides
that a 5i drug is not generally dispensed through a
retail community pharmacy if 70 percent or more
of the sales (based on units at the NDC–9 level) of
the 5i drug, were to entities other than retail
community pharmacies or wholesalers for drugs
distributed to retail community pharmacies.
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As specified in section 1860D–
14B(b)(2) of the Act, the AnMP for a Part
D rebatable drug for an applicable
period is equal to the sum of the
products of (1) the AMP for the Part D
rebatable drug reported for each
calendar quarter of the applicable
period, and (2) the total units of the Part
D rebatable drug reported for each of the
corresponding calendar quarters of the
applicable period divided by the total
units of the Part D rebatable drug
reported for the 4 calendar quarters in
the applicable period. The following
formula illustrates how CMS would
calculate the AnMP for a Part D
rebatable drug as proposed in
§ 428.202(b):
(AMP for calendar quarter beginning
October) multiplied by (sum of
monthly units for October calendar
quarter divided by total units for 12month applicable period) +
(AMP for calendar quarter beginning
January) multiplied by (sum of
monthly units for January calendar
quarter divided by total units for 12month applicable period) +
(AMP for calendar quarter beginning
April) multiplied by (sum of
monthly units for April calendar
quarter divided by total units for 12month applicable period) +
(AMP for calendar quarter beginning
July) multiplied by (sum of monthly
units for July calendar quarter
divided by total units for 12-month
applicable period)
In § 428.202(b)(2), CMS proposes that
the first applicable period for a Part D
rebatable drug will be the earliest
applicable period that follows the
payment amount benchmark period
identified in proposed § 428.202(c)(1)
through (4). For a Part D rebatable drug
first approved or licensed on or before
October 1, 2021, with a payment
amount benchmark period identified in
§ 428.202(c)(1), the first applicable
period would begin on October 1, 2022
and end on September 30, 2023. For a
Part D rebatable drug first approved or
licensed on or before October 1, 2021
with a payment amount benchmark
period identified in § 428.202(c)(3), or a
subsequently approved drug with a
payment amount benchmark period
identified in § 428.202(c)(2) or (4), the
first applicable period would begin on
October 1 of the year following the
payment amount benchmark period
identified in proposed § 428.202(c)(2)
through (4). As described below, CMS is
soliciting comments on alternative
policies for determining the payment
amount benchmark period in certain
instances of missing AMP. In the case of
a Part D rebatable drug that was
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previously a selected drug as described
in proposed § 428.202(c)(5) for which
the payment amount benchmark period
is reset as the last calendar year of the
price applicability period for such drug,
the earliest applicable period that
follows the reset payment amount
benchmark period would begin on
October 1 of the year following the
payment amount benchmark period
identified in proposed § 428.202(c)(5).
The date that CMS will use to determine
when a drug is first approved or
licensed is the FDA approval date that
the manufacturer reports to the
Medicaid Drug Programs system under
section 1927(b)(3)(A)(v) of the Act.
(2) Identification of the Payment
Amount Benchmark Period
Consistent with section 1860D–
14B(g)(3) of the Act and as described in
sections 40.2.2 and 40.3 of the revised
Medicare Part D Drug Inflation Rebate
Guidance, CMS proposes in
§ 428.202(c)(1) that for a drug first
approved or licensed by the FDA on or
before October 1, 2021, the payment
amount benchmark period is the period
beginning on January 1, 2021 and
ending on September 30, 2021. For a
subsequently approved drug, CMS
proposes in § 428.202(c)(2) that the
payment amount benchmark period
would be the first calendar year
beginning after the drug’s first marketed
date, as specified under section 1860D–
14B(b)(5)(A) of the Act. To identify the
payment amount benchmark period for
a Part D rebatable drug, CMS would use
the FDA approval date or the first
marketed date reported under section
1927(b)(3)(A)(v) of the Act, as
applicable.
(a) Proposal To Establish a Payment
Amount Benchmark Period in Certain
Instances of Missing AMP
Section 1860D–14B of the Act does
not expressly address how CMS should
calculate the benchmark period
manufacturer price for a Part D rebatable
drug when a manufacturer has not
reported AMP during the payment
amount benchmark period identified by
statute. For example, as described in the
revised Medicare Part D Drug Inflation
Rebate Guidance, while section 1860D–
14B(g)(3) of the Act contemplates that
drugs first approved or licensed by the
FDA on or before October 1, 2021,
would have a payment amount
benchmark period of January 1, 2021,
through September 30, 2021, the statute
does not address circumstances in
which such drugs are not marketed until
after October 1, 2021, and thus lack
AMP from January 1, 2021, through
September 30, 2021, to calculate the
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benchmark period manufacturer price.
In response to comments, CMS stated in
section 40.1.2 of the revised Medicare
Part D Drug Inflation Rebate Guidance
that Part D rebatable drugs first
approved or licensed on or before
October 1, 2021, that were not marketed
until after that date and thus did not
have AMP in the statutorily defined
payment amount benchmark period
(that is, January 1, 2021, through
September 30, 2021) would be treated in
the same manner as subsequently
approved drugs for purposes of
establishing the payment amount
benchmark period, benchmark period
CPI–U, first applicable period, and first
applicable period CPI–U. In the revised
guidance, CMS also stated that it
intended to address this policy in future
rulemaking and would solicit comments
on this policy at that time.
Based on further review, CMS has
observed that a number of NDC–9s of
Part D rebatable drugs approved on or
before October 1, 2021, do not have
AMP reported in the period of January
1, 2021, through September 30, 2021,
and a number of NDC–9s of
subsequently approved drugs do not
have AMP reported in the first calendar
year beginning after the drug’s first
marketed date. To enable CMS to
calculate the benchmark period
manufacturer price and inflation rebate
amounts for these NDC–9s, CMS is
proposing in § 428.202(c)(3) that for a
Part D rebatable drug first approved or
licensed on or before October 1, 2021,
for which there are no quarters during
the period beginning on January 1, 2021,
and ending on September 30, 2021, for
which AMP has been reported under
section 1927(b)(3) of the Act, CMS
would identify the payment amount
benchmark period as the first calendar
year, which would be no earlier than
calendar year 2021, in which such drug
has at least 1 quarter of AMP reported.
Said differently, to identify the payment
amount benchmark period for the
purpose of calculating the benchmark
period manufacturer price for a Part D
rebatable drug first approved or licensed
on or before October 1, 2021, CMS
would first look to the period from
January 1, 2021, to September 30, 2021
and if no AMP was reported to the
MDRP for that 3-quarter period, CMS
would then identify the payment
amount benchmark period as the first
calendar year no earlier than calendar
year 2021 in which such drug has at
least 1 quarter of AMP reported.
Similarly, in proposed § 428.202(c)(4),
CMS proposes that for a subsequently
approved drug for which there are no
quarters during the first calendar year
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beginning after the drug’s first marketed
date for which AMP has been reported
under section 1927(b)(3), the payment
amount benchmark period would be the
first calendar year in which such drug
has at least 1 quarter of AMP reported.
To identify the payment amount
benchmark period for the purpose of
calculating the benchmark period
manufacturer price for a subsequently
approved drug, CMS would look to the
first calendar year beginning after the
drug’s first marketed date and if no
AMP was reported to the MDRP for such
NDC–9 for that 4-quarter period, CMS
would then identify the payment
amount benchmark period as the first
calendar year in which such drug has at
least 1 quarter of AMP reported. This
approach (or the alternative approaches
described below), if finalized, would
replace the policy in the revised
Medicare Part D Drug Inflation Rebate
Guidance to treat Part D rebatable drugs
first approved or licensed on or before
October 1, 2021, that were not marketed
until after that date in the same manner
as subsequently approved drugs. As
proposed in § 428.202(b)(2), the first
applicable period for such drug would
begin on October 1 of the year following
the payment amount benchmark period.
This policy would apply to Part D
rebatable drugs first approved or
licensed on or before October 1, 2021,
drugs first approved or licensed on or
before October 1, 2021, but not
marketed until after that date, as well as
subsequently approved drugs.
As an example of how CMS would
identify the payment amount
benchmark period as proposed under
§ 428.202(c)(3), if a Part D rebatable drug
that was first approved or licensed by
the FDA on July 7, 2021, and has a first
marketed date of September 15, 2021,
does not have AMP reported in the
period beginning January 1, 2021 and
ending September 30, 2021, but does
have AMP reported for the second
calendar quarter of 2022, CMS would
identify the payment amount
benchmark period for such drug as
calendar year 2022 (that is, January 1,
2022, through December 31, 2022). In
this example, the benchmark period
CPI–U would be the CPI–U for January
2022, the first applicable period would
be the applicable period beginning
October 1, 2023, and ending September
30, 2024, and the applicable period CPI–
U would be the CPI–U for October 2023.
Similarly, as an example of how CMS
would identify the payment amount
benchmark period as proposed under
§ 428.202(c)(4), if a subsequently
approved drug with a first marketed
date of December 15, 2021, does not
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have AMP reported for any quarters in
calendar year 2022 (that is, the first
calendar year after the drug’s first
marketed date) but does have AMP
reported for the first calendar quarter of
2023, CMS would identify the payment
amount benchmark period as calendar
year 2023 (that is, January 1, 2023,
through December 31, 2023). In this
example, the benchmark period CPI–U
would be the CPI–U for January 2023,
the first applicable period for this drug
would be the applicable period
beginning October 1, 2024, and ending
September 30, 2025, and the applicable
period CPI–U would be the CPI–U for
October 2024.
CMS is soliciting comments on this
approach, as well as the alternatives
described below.
(b) Comment Solicitation on
Alternatives Considered for Calculating
the Benchmark Period Manufacturer
Price When AMP Is Missing
CMS is aware that one reason why a
manufacturer may not report AMP for
any quarters of a payment amount
benchmark period described in
§ 428.202(c)(1) or (2), as applicable, is
that a manufacturer may acquire a Part
D rebatable drug from another
manufacturer and, due to that
acquisition and the use of a new labeler
code, obtain a new NDC–9 for that Part
D rebatable drug. In this instance, the
NDC–9 of the selling manufacturer and
the NDC–9 of the buying manufacturer
belong to the same dosage form and
strength and therefore the same Part D
rebatable drug. Although the buying
manufacturer may not have AMP for the
new NDC–9 to report to the Medicaid
Drug Programs system for the Part D
rebatable drug’s payment amount
benchmark period described in
§ 428.202(c)(1) or (c)(2), the buying
manufacturer is required by the MDRP
to report for the new NDC–9 the base
date AMP associated with the dosage
form and strength to which the new
NDC–9 belongs.583 This base date AMP
is equal to the quarterly AMP that a
manufacturer reports as described in
§ 447.509(a)(7)(ii)(B). There also may be
instances outside of the acquisition
context in which a new NDC–9 for an
existing dosage form and strength is
reported to the MDRP. To prevent a
manufacturer from resetting the
payment amount benchmark period and
therefore the benchmark period
manufacturer price by obtaining a new
NDC–9 for the Part D rebatable drug,
583 Medicaid Drug Rebate Program Notice, Release
No. 90 (April 18, 2014). https://www.medicaid.gov/
medicaid-chip-program-information/by-topics/
prescription-drugs/downloads/rx-releases/mfrreleases/mfr-rel-090.pdf.
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CMS stated in section 40.2.2 of the
revised Medicare Part D Drug Inflation
Rebate Guidance that it will use the
benchmark period manufacturer price of
the earliest NDC–9 of the Part D
rebatable drug.
After further consideration of this
policy and the data that are available to
CMS in the Medicaid Drug Programs
system, CMS does not believe that
calculating the benchmark period
manufacturer price using the three or
four quarters, as applicable, of AMP
reported in the payment amount
benchmark period described in
proposed § 428.202(c)(1) or (2) of the
earliest NDC–9 of the Part D rebatable
drug is operationally feasible at this
time. Although the buying manufacturer
is required by the MDRP to report for
the new NDC–9 the base date AMP
associated with the earliest NDC–9 of
the dosage form and strength, and to
report the first marketed date associated
with the earliest NDC–9 of the dosage
form and strength as the first marketed
date for the new NDC–9,584 the buying
manufacturer is not required to report
which NDC–9 was used to determine
the base date AMP and first marketed
date. CMS may therefore lack the
information necessary to identify the
earliest NDC–9 of the Part D rebatable
drug for purposes of determining the
benchmark period manufacturer price to
be used in calculating the inflation
rebate amount.
CMS understands that statutory
provisions at section 1860D–14B of the
Act require that CMS establish the
payment amount benchmark period at
the dosage form and strength level, and
that resetting the payment amount
benchmark period for a new NDC–9 of
an existing Part D rebatable drug may
not fully align with this directive.
Simultaneously, and as described above
in this section III.I.3.c.2.b, CMS
understands there may be a gap in the
AMP data available to calculate the
benchmark period manufacturer price at
the dosage form and strength level for
certain drugs. To enable CMS to
calculate the benchmark period
manufacturer price when a new NDC–
584 See 88 FR 34238, 34257 (May 26, 2023).
Section 1927(c)(2)(A)(ii)(II) of the Act expressly
provides that the base date AMP quarter, with
respect to a dosage form and strength of a drug, is
established ‘‘without regard to whether or not the
drug has been sold or transferred to an entity,
including a division or subsidiary of the
manufacturer . . .’’ See also the data field
definition of market date: ‘‘For S, I, and N drugs
marketed under an FDA-approved application (for
example, BLA, NDA, ANDA), the earliest date the
drug was first marketed under the application
number by any labeler.’’ https://www.medicaid.gov/
sites/default/files/medicaid-chip-programinformation/by-topics/prescription-drugs/
downloads/recordspecficationanddefinitions.pdf.
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9 of an existing Part D rebatable drug is
reported to the MDRP and that NDC–9
lacks AMP data for the time period
described in proposed § 428.202(c)(1) or
(2), CMS is soliciting comments on
alternative policy options that are
described in more detail below.
First, CMS is soliciting comments on
a modified version of the policy
described in section 40.1.2 of the
revised Medicare Part D Drug Inflation
Rebate Guidance. Under this modified
policy, if a new NDC–9 of an existing
Part D rebatable drug is reported to the
MDRP, CMS would calculate the
benchmark period manufacturer price
for such NDC–9 using the base date
AMP reported by a manufacturer under
section 1927(b)(3) of the Act for such
Part D rebatable drug, if such base date
AMP was reported for a calendar quarter
that overlaps with the time period
described in proposed § 428.202(c)(1) or
(2), as applicable for that Part D
rebatable drug. CMS believes this
modified policy would be operationally
feasible because CMS would calculate
the benchmark period manufacturer
price using the base date AMP that is
reported with the new NDC–9; CMS
therefore would not need to identify the
earliest NDC–9 of the Part D rebatable
drug. Under this policy, CMS would
only use the base date AMP to calculate
the benchmark period manufacturer
price if the base date AMP was
associated with a calendar quarter that
overlapped with the time period
described in proposed § 428.202(c)(1) or
(2), as applicable for that Part D
rebatable drug. If CMS were to adopt
this alternative approach, CMS would
expect to operationalize it through
conforming changes to proposed
§ 428.202(c) and other applicable
proposed regulatory text.
CMS notes that, if CMS were to
finalize this alternative approach, CMS
would be unable to use this approach to
calculate the benchmark period
manufacturer price in the case of a new
NDC–9 of an existing Part D rebatable
drug with base date AMP that does not
overlap with the time period described
in proposed § 428.202(c)(1) or (2). In
such instances, CMS would either
establish a future payment amount
benchmark period using an approach
similar to that described in proposed
§ 428.202(c)(3) and (4) or apply one of
the other alternative policies described
below.
Another alternative CMS is
considering is to require manufacturers
of Part D rebatable drugs to submit to
CMS AMP data for the time period
identified under proposed
§ 428.202(c)(1) or (2) in cases where the
manufacturer did not report AMP to the
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MDRP under section 1927(b)(3) of the
Act for such period but AMP data are
available either for the NDC–9 or for
another NDC–9 within the same dosage
form and strength. For example, if the
quarter for which a manufacturer
reports base date AMP for a new NDC–
9 of an existing dosage form and
strength does not overlap with the time
period identified under proposed
§ 428.202(c)(1) or (2), but the earliest
NDC–9 of the dosage form and strength
that served as the basis for the base date
AMP has AMP data available during any
quarter of that time period, CMS would
require manufacturers to report such
AMP data. For a Part D rebatable drug
with a payment amount benchmark
period identified under proposed
§ 428.202(c)(1), a manufacturer would
be required to submit to CMS AMP data
for the calendar quarters in the period
beginning January 1, 2021, and ending
on September 30, 2021, to the extent
such drug was first marketed before
September 30, 2021. For a subsequently
approved drug with a payment amount
benchmark period identified under
proposed § 428.202(c)(2), a
manufacturer would be required to
submit to CMS AMP data for the first
calendar year beginning after the drug’s
first marketed date. CMS acknowledges
the intersection between a potential
reporting requirement under the
Medicare Part D Drug Inflation Rebate
Program for manufacturers to provide
AMP data and existing AMP data
reporting requirements for
manufacturers under the MDRP. Should
CMS pursue this option, CMS would
explore using existing AMP reporting
processes for the MDRP to
operationalize any new AMP reporting
requirement. This approach of requiring
manufacturers to report such
information would be consistent with
CMS’ understanding of the provisions of
section 1860D–14B of the Act requiring
CMS to establish the payment amount
benchmark period at the dosage form
and strength level, and with CMS’
authority under sections 1102(a) and
1871(a)(1) of the Act to make rules and
regulations as necessary for the efficient
administration of programs, including
the Medicare Part D Drug Inflation
Rebate Program. CMS welcomes
comments on the method by which
CMS could collect such information, the
timing of the potential collection and
deadlines, and whether information
reported by manufacturers should be
taken into account for purposes of
compiling the Rebate Reports for a Part
D rebatable drug or instead only be
included in the reconciliation processes
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specified in proposed § 428.401(d) and
described later in this proposed rule.
CMS is also considering an alternative
policy whereby CMS would calculate
the benchmark period manufacturer
price for a new NDC–9 of an existing
Part D rebatable drug that lacks AMP
data for the time period described in
§ 428.202(c)(1) or (2) using a reasonable
proxy metric. CMS welcomes comments
on potential proxy metrics CMS could
use to calculate the benchmark period
manufacturer price for a new NDC–9 of
an existing dosage form and strength for
which no AMP data are reported for
such periods.
These alternative policy options are
intended to achieve the same goal as the
policy described in section 40.2.2 of the
revised Medicare Part D Drug Inflation
Rebate Guidance (that is, to
disincentivize a manufacturer from
resetting its payment amount
benchmark period by obtaining a new
NDC–9 for an existing Part D rebatable
drug). CMS also welcomes comments on
the alternative policy described in the
revised Medicare Part D Drug Inflation
Rebate Guidance whereby CMS would
treat drugs first approved or licensed on
or before October 1, 2021, that were not
marketed until after that date in the
same manner as subsequently approved
drugs for purposes of establishing the
payment amount benchmark period,
benchmark period CPI–U, first
applicable period, and first applicable
period CPI–U. CMS is soliciting
comments on these alternatives and may
adopt one or more of such alternatives
in the final rule based on comments
received. Additionally, CMS is seeking
comments on other policies that CMS
should consider to prevent
manufacturers from inappropriately
resetting the payment amount
benchmark period by obtaining a new
NDC–9 for an existing Part D rebatable
drug.
Under CMS’ proposed policy to
identify a payment amount benchmark
period in certain instances of missing
AMP as proposed in § 428.202(c)(3) and
(4) and each of these alternatives
considered, CMS would consider any
restatements to the AMP data used to
calculate the benchmark period
manufacturer price during
reconciliation, as specified in proposed
§ 428.401(d) and described later in this
proposed rule. Furthermore, CMS
would also monitor the extent to which
manufacturers obtain a new NDC–9 for
the same Part D rebatable drug in a
manner that could result in
inappropriately resetting the payment
amount benchmark period or otherwise
affect the calculation of the benchmark
period manufacturer price. CMS
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reminds manufacturers of their
reporting obligations under section
1927(b) of the Act and § 447.510 of this
title and that failure to provide timely
information may result in penalties as
detailed in section 1927(b)(3)(C)(i) of the
Act.
If finalized, CMS would apply the
policies described above to rebate
calculations beginning with the
applicable period that began on October
1, 2022. CMS has determined that,
consistent with the policy described in
section III.I.1, in order to calculate
inflation rebates for Part D rebatable
drugs that do not have AMP or other
pricing data available under section
1927(b)(3) on which to base the
benchmark period manufacturer price,
CMS’ proposed policy must apply for
applicable periods beginning with the
applicable period that began on October
1, 2022.
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(c) Identification of the Payment
Amount Benchmark Period for a Part D
Rebatable Drug No Longer Considered
To Be a Selected Drug
In proposed § 428.202(c)(5), CMS
proposes to codify policies described in
section 40.2.2 of the revised Medicare
Part D Drug Inflation Rebate Guidance
relating to the identification of the
payment amount benchmark period for
a selected drug (as defined in section
1192(c) of the Act) with respect to a
price applicability period (as defined in
section 1191(b)(2) of the Act) in the case
such Part D rebatable drug is no longer
considered to be a selected drug. The
Medicare Part D Drug Inflation Rebate
Program applies to selected drugs
notwithstanding the status of the drug
as a selected drug. However, the
calculation of certain components of the
rebate amount formula for selected
drugs depends upon whether the
selected drug has reached the end of its
price applicability period and is no
longer considered to be a selected drug
under section 1192(c) of the Act.
Specifically, section 1860D–14B(b)(5)(C)
of the Act specifies a different payment
amount benchmark period and
benchmark period CPI–U for a Part D
rebatable drug in the case such drug is
no longer considered to be a selected
drug under section 1192(c) of the Act,
for each applicable period beginning
after the price applicability period with
respect to such drug. Accordingly, in
such a case where a Part D rebatable
drug is no longer a selected drug, CMS
proposes in § 428.202(c)(5) that the
payment amount benchmark period will
be reset as the last calendar year of such
price applicability period for such
selected drug.
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(3) Calculation of the Benchmark Period
Manufacturer Price
CMS proposes in § 428.202(d) that,
subject to proposed § 428.202(g), to
determine the benchmark period
manufacturer price for a Part D rebatable
drug, CMS would use the AMP reported
by a manufacturer to the Medicaid Drug
Programs system under sections
1927(b)(3)(A)(i) and (ii) of the Act for
each calendar quarter of the payment
amount benchmark period, as identified
in accordance with proposed
§ 428.202(c), as well as the units
reported by a manufacturer under
section 1927(b)(3)(A)(iv) of the Act for
each month of such payment amount
benchmark period. For a Part D
rebatable drug first approved or licensed
on or before October 1, 2021, section
1860D–14B(b)(4) of the Act specifies
that the benchmark period manufacturer
price is the sum of the products of (1)
the AMP for the Part D rebatable drug
reported for each calendar quarter of the
payment amount benchmark period
(that is, January 1, 2021, through
September 30, 2021), and (2) the total
units reported for each of the
corresponding calendar quarters of the
payment amount benchmark period
divided by the total units of the Part D
rebatable drug reported for the 3
calendar quarters in the payment
amount benchmark period. The
following formula illustrates how CMS
would calculate the benchmark period
manufacturer price for a Part D rebatable
drug with a payment amount
benchmark period identified under
proposed § 428.202(c)(1), as proposed in
§ 428.202(d)(1):
(AMP for calendar quarter beginning
January 2021) multiplied by (sum of
monthly AMP units for January
2021 calendar quarter divided by
sum of the units reported for the 3
quarters of the payment amount
benchmark period) +
(AMP for calendar quarter beginning
April 2021) multiplied by (sum of
monthly AMP units for April 2021
calendar quarter divided by sum of
the units reported for the 3 quarters
of the payment amount benchmark
period) +
(AMP for calendar quarter beginning
July 2021) multiplied by (sum of
monthly AMP units for July 2021
calendar quarter divided by sum of
the units reported for the 3 quarters
of the payment amount benchmark
period)
For a Part D rebatable drug with a
payment amount benchmark period
identified under proposed
§ 428.202(c)(2) through (5), the
following formula illustrates how CMS
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would calculate the benchmark period
manufacturer price for a Part D rebatable
drug as proposed in § 428.202(d)(2):
(AMP for calendar quarter beginning
January) multiplied by (sum of
monthly AMP units for January
calendar quarter divided by sum of
the monthly units reported for the
4 quarters of the payment amount
benchmark period) +
(AMP for calendar quarter beginning
April) multiplied by (sum of
monthly AMP units for April
calendar quarter divided by sum of
the monthly units reported for the
4 quarters of the payment amount
benchmark period) +
(AMP for calendar quarter beginning
July) multiplied by (sum of monthly
AMP units for July calendar quarter
divided by sum of the monthly
units reported for the 4 quarters of
the payment amount benchmark
period) +
(AMP for calendar quarter beginning
October) multiplied by (sum of
monthly AMP units for October
calendar quarter divided by sum of
the monthly units reported for the
4 quarters of the payment amount
benchmark period)
(4) Identification of the Benchmark
Period CPI–U
To calculate the inflation-adjusted
payment amount in accordance with
section 1860D–14B(b)(3), CMS must
identify the benchmark period CPI–U.
As described in the revised Medicare
Part D Drug Inflation Rebate Guidance
and in accordance with section 1860D–
14B(g)(4), CMS proposes in
§ 428.202(e)(1) that the benchmark
period CPI–U for a Part D rebatable drug
first approved or licensed by the FDA
on or before October 1, 2021, would be
the CPI–U for January 2021. For a
subsequently approved drug, CMS
proposes in § 428.202(e)(2) that the
benchmark period CPI–U would be the
CPI–U for January of the first calendar
year beginning after the drug’s first
marketed date, as required under
section 1860D–14B(b)(5)(A).
As described earlier in this proposed
rule, CMS has observed that a number
of NDC–9s of Part D rebatable drugs
approved or licensed on or before
October 1, 2021, do not have AMP
reported in the period beginning
January 1, 2021, and ending September
30, 2021, and a number of NDC–9s of
subsequently approved drugs do not
have AMP reported in the first calendar
year following the drug’s first marketed
date. To enable CMS to calculate the
benchmark period manufacturer price
and inflation rebate amounts for these
NDC–9s, CMS is proposing in
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§ 428.202(c)(3) and (4) to identify the
payment amount benchmark period for
such NDC–9s as the first calendar year,
which would be no earlier than calendar
year 2021, in which such drug has at
least 1 quarter of AMP data reported. As
previously discussed, CMS is soliciting
comments on alternative methodologies
to identify the payment amount
benchmark period and calculate the
benchmark period manufacturer price to
address certain instances in which AMP
has not been reported and, if any such
alternatives are adopted, CMS may
adopt conforming modifications to
proposed § 428.202(e). To identify the
benchmark period CPI–U for an NDC–9
described in proposed § 428.202(c)(3),
CMS further proposes in § 428.202(e)(3)
that for a Part D rebatable drug first
approved on or before October 1, 2021,
for which there are no quarters during
the period beginning on January 1, 2021,
and ending on September 30, 2021, for
which AMP has been reported to the
MDRP, the benchmark period CPI–U
would be the CPI–U for January of the
calendar year in which such drug has at
least 1 quarter of AMP reported. CMS
proposes in § 428.202(e)(4) that for a
subsequently approved drug for which
there are no quarters during the first
calendar year beginning after the drug’s
first marketed date for which AMP has
been reported to the MDRP, the
benchmark period CPI–U is the CPI–U
for January of the calendar year in
which such drug has at least 1 quarter
of AMP reported.
As discussed previously, the
Medicare Part D Drug Inflation Rebate
Program applies to selected drugs
notwithstanding the status of the drug
as a selected drug. However, the
calculation of certain components of the
applicable rebate amount formula for
selected drugs depends upon whether
the selected drug has reached the end of
its price applicability period and is no
longer considered to be a selected drug
under section 1192(c) of the Act. In
accordance with section 1860D–
14B(b)(5)(C) of the Act, in such a case
where a Part D rebatable drug is no
longer a selected drug, CMS proposes in
§ 428.202(e)(5) that the benchmark
period CPI–U will be the CPI–U for
January of the last calendar year of such
price applicability period.
(5) Calculation of the Inflation-Adjusted
Payment Amount
As specified in section 1860D–
14B(b)(3) of the Act and described in
section 40.2.3 of the revised Medicare
Part D Drug Inflation Rebate Guidance,
the inflation-adjusted payment amount
with respect to a Part D rebatable drug
and applicable period is the benchmark
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period manufacturer price increased by
the percentage by which the applicable
period CPI–U exceeds the benchmark
period CPI–U. CMS proposes in
§ 428.202(f) to calculate the inflationadjusted payment amount for a Part D
rebatable drug by dividing the
applicable period CPI–U by the
benchmark period CPI–U and then
multiplying the quotient by the
benchmark period manufacturer price.
The following formula illustrates how
CMS would calculate the inflationadjusted payment amount for a Part D
rebatable drug as proposed in
§ 428.202(f):
(Benchmark period manufacturer price)
multiplied by (applicable period
CPI–U divided by benchmark
period CPI–U)
As described earlier in this proposed
rule and proposed in § 428.202(a), CMS
will use the inflation-adjusted payment
amount to calculate the per unit Part D
drug inflation rebate amount by
determining the amount by which the
AnMP for a Part D rebatable drug
exceeds the inflation-adjusted payment
amount for a Part D rebatable drug for
an applicable period.
(6) Situations in Which Manufacturers
Do Not Report Units Under Section
1927(b)(3)(A)(iv)
Section 1860D–14B of the Act
generally requires CMS to determine the
per unit Part D drug inflation rebate
amount using the monthly units
reported by manufacturers to the
Medicaid Drug Programs system under
section 1927(b)(3)(A)(iv) of the Act.
CMS understands it is possible that a
manufacturer may not have sales or
monthly units of a COD to report to the
Medicaid Drug Programs system for a
calendar quarter because, for example,
there may be a temporary interruption
in sales of the COD, or there may be no
sales immediately after the drug is first
approved or licensed by the FDA. CMS
proposes in § 428.202(g)(1) to codify the
policy described in section 40.1.2 of the
revised Medicare Part D Drug Inflation
Rebate Guidance, whereby in cases
where there are 1 or more quarter(s) in
the payment amount benchmark period
or applicable period for which a
manufacturer has not reported units
under section 1927(b)(3)(A)(iv) of the
Act but has reported AMP under
sections 1927(b)(3)(A)(i) and (ii) of the
Act, CMS would calculate the
benchmark period manufacturer price or
AnMP, as applicable, using data only
from quarter(s) with units. That is,
quarter(s) in the payment amount
benchmark period or applicable period
for which a manufacturer has not
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reported units under section
1927(b)(3)(A)(iv) of the Act would be
excluded from the calculation. CMS
proposes in § 428.202(g)(2) to codify the
policy described in section 40.1.2 of the
revised guidance whereby if there are no
quarters of the payment amount
benchmark period or applicable period
for which a manufacturer has reported
units under section 1927(b)(3)(A)(iv) of
the Act, but the manufacturer has
reported AMP under sections
1927(b)(3)(A)(i) and (ii) of the Act for at
least 1 quarter of such period, CMS
would use the average of the AMP over
the calendar quarters of the payment
amount benchmark period or applicable
period for which AMP is reported to
calculate the benchmark period
manufacturer price or AnMP,
respectively.
iv. Determination of the Total Number
of Units Dispensed Under Part D
In § 428.203(a), CMS proposes to
codify the existing policy established in
the revised Medicare Part D Drug
Inflation Rebate Guidance whereby CMS
would determine the total number of
units of each Part D rebatable drug
dispensed under Part D and covered by
Part D sponsors based on information
reported to CMS by Part D plan
sponsors on the Part D PDE records for
the 12-month applicable period. More
specifically, CMS would determine the
total number of units from the Quantity
Dispensed field on the PDE record for
each Part D rebatable drug with gross
covered prescription drug costs greater
than zero. Because the PDE record does
not provide the unit type used to
determine Quantity Dispensed, CMS
proposes in § 428.203(a)(2) that CMS
would crosswalk the information from
the PDE record to a drug database that
provides the unit type for an NDC, such
as Medi-Span or the FDA’s
Comprehensive NDC Structured Product
Labeling (SPL) Data Element (NSDE)
file, matching on the NDC of the Part D
rebatable drug. CMS understands that in
limited instances, the unit type obtained
from such drug databases may not
match the AMP unit type reported by
manufacturers to the Medicaid Drug
Programs system, and in these cases,
CMS would convert the total units
reported on the PDE record to the AMP
units reported to the Medicaid Drug
Program system.
CMS conducts a thorough review of
PDE records, which includes the
identification of outliers in the quantity
dispensed field of PDE records, as part
of the Part D payment reconciliation
process that occurs between CMS and
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plan sponsors each year.585 CMS
intends to rely on this payment
reconciliation process, through which
Part D plan sponsors have an
opportunity to correct PDE records
flagged by CMS as containing potential
outliers, to resolve outliers that would
otherwise impact the Part D drug
inflation rebate amount calculated
under proposed § 428.201(a). Because
PDE records are not updated to reflect
the resolution of outliers identified
through the Part D payment
reconciliation process for a given
calendar year until after CMS plans to
send Rebate Reports for the applicable
period (capturing data that include the
first three quarters of that calendar
year), the Rebate Report will not reflect
the resolution of unit outliers identified
through the Part D payment
reconciliation process. However,
because CMS intends to conduct a
reconciliation of the rebate amount with
additional PDE run-out (as proposed in
§ 428.401(d) and described later in this
proposed rule), the reconciled rebate
amounts will reflect the resolution of
any unit outliers corrected by Part D
plan sponsors through the Part D
payment reconciliation process. CMS
does not intend to conduct separate
outlier analysis of PDE for the purposes
of the Medicare Part D Drug Inflation
Rebate Program, but CMS did consider
several adjustments to reduce the effect
of outliers not resolved through the Part
D payment reconciliation process,
including removal of PDE records that
were identified by CMS as having
potential outlier quantity dispensed
fields but were neither corrected nor
verified by Part D plan sponsors,
removal of the quantity dispensed field
for certain records at or above a certain
statistically derived threshold, and
imputing quantity dispensed values for
such records. CMS is soliciting
comments on this proposed approach to
rely on CMS’ existing review of PDE
records, as well as on the adjustments
considered to reduce the effect of
outliers not resolved through the Part D
payment reconciliation process.
As proposed in § 428.203(b), CMS
would remove from the total number of
units any units of a generic drug
dispensed on or after the date that such
generic drug no longer meets the
definition of a Part D rebatable drug, as
well as units acquired through the 340B
Program, as described in section III.I.3.c
of this proposed rule. CMS invites
comments on any additional units that
585 See https://www.hhs.gov/guidance/document/
pde-analysis-process-withheld-and-invoicedoutlier-pdes.
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should be excluded from the rebate
amount calculation.
(1) Removal of Units When a Generic
Drug Is No Longer a Part D Rebatable
Drug
In § 428.203(b)(1), CMS proposes to
codify the policy established in section
40.2.8 of the revised Medicare Part D
Drug Inflation Rebate Guidance to
exclude from the rebate calculation any
units of a generic drug dispensed on or
after the date that such generic drug no
longer meets the definition of a Part D
rebatable drug. To determine whether a
generic drug that meets the definition of
a Part D rebatable drug on the first day
of an applicable period ceases to meet
such definition later in the applicable
period, CMS will use the most recent
version of the downloadable FDA
Orange Book to identify whether FDA
has approved a 505(j) ANDA for a drug
that is rated as therapeutically
equivalent to such generic drug. If CMS
determines that FDA has approved such
a therapeutically equivalent drug under
a 505(j) ANDA, CMS will then use the
NDC Directory, including historical
information from NDC Directory files
such as discontinued, delisted, and
expired listings provided by FDA or
published on the FDA website to
determine the marketing status of such
therapeutically equivalent drug and to
determine whether, during the
applicable period, the therapeutically
equivalent drug was marketed.
Similarly, CMS will use the NDC
Directory to identify whether the
reference listed drug, or an authorized
generic of the reference listed drug was
marketed during the applicable period.
CMS will exclude from the rebate
calculation any units dispensed on or
after the first day of the calendar month
that a generic drug no longer meets the
definition of a Part D rebatable drug.
CMS intends to apply this unit
exclusion at the month level and would
exclude all units of a generic drug that
ceases to meet the definition of a Part D
rebatable drug beginning with the first
day of the first month when a
therapeutically equivalent drug
approved under a 505(j) ANDA is
marketed based on the marketing start
date in the NDC Directory or when the
reference listed drug, or an authorized
generic of the reference listed drug is
marketed based on the marketing start
date in the NDC Directory. CMS
proposes to apply this exclusion each
calendar month because the Orange
Book downloadable data files are
updated monthly.
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(2) Exclusion of 340B Acquired Units
From Part D Rebatable Drug
Requirements
Section 1860D–14B(b)(1)(B) of the Act
requires that beginning with plan year
2026, CMS shall exclude from the total
number of units for a Part D rebatable
drug, with respect to an applicable
period, those units for which a
manufacturer provides a discount under
the 340B Program. Because this
requirement starts after the first quarter
of the applicable period that begins on
October 1, 2025, the exclusion of 340B
units would only apply for the last three
quarters of this applicable period. That
is, CMS would exclude 340B units
starting on January 1, 2026.
Data on which units dispensed under
Part D and covered by Part D plan
sponsors were purchased under the
340B Program is unavailable under the
data sources specified at section 1860D–
14B(d) of the Act (that is, information
submitted by manufacturers, States, and
Part D plan sponsors), and CMS does
not currently have access to this data
through other means. CMS understands
that the 340B status of a Part D drug is
usually not known by the dispenser at
the point-of-sale, and that 340B covered
entities (hereinafter ‘‘covered entities’’)
typically identify the 340B status of a
Part D drug retrospectively. Because the
covered entity and CMS do not
exchange dispensed Part D drug
information confirming the 340B status
of a Part D rebatable drug, CMS is
unable to identify 340B units at the
claim-level at this time. For these
reasons, CMS believes it necessary to
establish an estimation methodology to
remove 340B units from the total
number of units for a Part D rebatable
drug, as described in this section.
(a) Estimation Methodology To Remove
340B Units From Rebate Calculations
To fulfill the statutory requirement to
remove 340B units from rebate
calculations beginning on January 1,
2026, CMS is proposing in
§ 428.203(b)(2) a new policy to remove
units from the total number of units
dispensed of a Part D rebatable drug for
each applicable period based on a
calculated percentage that reflects the
portion of 340B purchasing relative to
total sales. CMS proposes the percentage
(hereinafter, ‘‘estimation percentage’’) to
equal the total number of units
purchased by covered entities under the
340B Program for an NDC–9, divided by
the total units sold of that NDC–9. An
example calculation for a Part D
rebatable drug for a given applicable
period is shown below for illustrative
purposes:
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Total number of units dispensed under
Part D determined under
§ 428.203(a), minus the units
determined under § 428.203(b)(1):
1,000
Estimation percentage:
Total number of units purchased by
covered entities under the 340B
Program: 5,000
Total units sold: 50,000
5,000 divided by 50,000 = 10 percent
340B units excluded under
§ 428.204(b)(2): 10 percent
multiplied by 1,000 = 100
The proposed estimation policy is
consistent with CMS’ authority under
section 1860D–14B(b)(1)(B) of the Act
and sections 1102(a) and 1871(a)(1) of
the Act, the latter of which provide the
authority to make rules and regulations
as necessary for the efficient
administration of programs, including
the Medicare Part D Drug Inflation
Rebate Program. Because the statutory
requirement to remove 340B units from
rebate calculations does not begin until
January 1, 2026, for the applicable year
that begins on October 1, 2025, CMS
proposes to apply the estimation
percentage only to those units
associated with claims with dates of
service in the last three quarters of the
applicable period (that is, January 1,
2026, through September 30, 2026).
To identify the numerator of the
estimation percentage (that is, the total
number of units purchased under the
340B Program for an NDC–9), CMS
proposes to use data from HRSA’s Prime
Vendor Program (PVP). Certain supply
chain entities report 340B unit data to
the PVP at the NDC–11 level, and based
on the data received, CMS would
aggregate these data at the NDC–9
level 586 to identify the total number of
340B units of a Part D rebatable drug
that covered entities purchased in a
given time period. CMS proposes to
work with HRSA to obtain the necessary
data from the PVP. CMS understands
that there are limitations of using the
PVP data, including that some covered
entities may choose not to participate in
the PVP, and CMS would not have
access to 340B purchases reported by
supply chain entities for this share of
covered entities. Further, certain 340B
purchases may not be reported to the
PVP if those purchases were made
through alternative distribution models
such as a covered entity purchasing
directly from a manufacturer, certain
specialty distribution channel
586 NDC–9 and NDC–11 numbers are identical
except for two numbers in NDC–11s that indicate
package size. Because of this, NDC–11 is more
granular than NDC–9, and multiple NDC–11
numbers can aggregate under a single NDC–9
number.
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purchases, or drugs that receive a 340B
rebate under the Ryan White HIV/AIDS
Program’s AIDS Drug Assistance
Program. CMS is soliciting comments on
what other data sources may be
available to calculate the numerator of
the estimation percentage. CMS is also
soliciting comments on how it could
account for potential underreporting of
340B units if data are not available on
certain 340B purchases, such as those
described above, that may not be
reported to the PVP.
To identify the denominator of the
estimation percentage (that is, the total
units sold of an NDC–9), CMS proposes
to use existing manufacturer reporting
under the Medicaid Drug Rebate
Program (MDRP) of unit sales.
Specifically, CMS proposes to use the
total number of units that are used to
calculate the monthly AMP and which
manufacturers are required to report to
CMS for each covered outpatient drug
(COD) in accordance with section
1927(b)(3)(A)(iv) of the Act. CMS
believes that using these unit data to
calculate an estimation percentage is
consistent with the use of these same
data to calculate the AnMP in proposed
§ 428.202(b) and the benchmark period
manufacturer price in proposed
§ 428.202(d).
CMS recognizes the importance of
ensuring that the numerator and
denominator of the proposed estimation
percentage reflect the same time period
of sales for units dispensed in the same
settings. CMS acknowledges that the
proposed data source for the numerator
(PVP data) reflects purchases by covered
entities that dispense or administer
340B-eligible drugs in retail community
pharmacies and in outpatient settings.
The proposed data source for the
denominator (unit sales used to
calculate AMP) represents, in
accordance with the definition of AMP
at section 1927(k)(1) of the Act, (1)
manufacturer sales to wholesalers for
drugs distributed to retail community
pharmacies, and (2) manufacturer sales
to retail community pharmacies that
purchase drugs directly from the
manufacturer. Therefore, the numerator
of the proposed estimation percentage
represents 340B units dispensed in
multiple settings, whereas the
denominator represents units typically
dispensed only in the retail community
pharmacy setting. CMS welcomes
evidence demonstrating how 340B
dispensing rates differ between the
retail community pharmacy setting
versus multiple settings and may
consider adjusting the estimation
percentage to reflect variation between
the percentage of 340B units dispensed
in multiple settings (that is, retail
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community pharmacies and outpatient
settings) and the percentage of 340B
units dispensed in only the retail
community pharmacy setting. The
proposed regulatory text at
§ 428.203(b)(2) would be subject to any
such adjustment factor that may be
adopted.
CMS also recognizes that the
proposed estimation percentage
represents the total number of 340B
units dispensed as a proportion of total
units dispensed, irrespective of
insurance/payor type. CMS is soliciting
comments on whether the agency
should further adjust the percentage of
340B units dispensed to the general
population to estimate the percentage of
340B units dispensed to Part D
beneficiaries for claims with dates of
service on or after January 1, 2026,
including comments on how the
percentage of 340B units dispensed to
the general population compares with
the percentage of 340B units dispensed
to Part D beneficiaries. CMS welcomes
evidence that demonstrates how these
percentages differ. CMS will consider
this information in developing its final
policies and may consider adjusting the
estimation percentage to reflect
variation between the percentage of
340B units dispensed to Part D
beneficiaries and the percentage of 340B
units dispensed to the general
population. The proposed regulatory
text at § 428.203(b)(2) would be subject
to any such adjustment factor that may
be adopted. CMS is also soliciting
comments on whether there are other
circumstances for which CMS should
apply an adjustment factor to the
estimation percentage.
CMS considered using alternative
data sources to calculate the estimation
percentage. To identify the total number
of units purchased under the 340B
Program to use in the numerator of the
estimation percentage, CMS considered
requiring other entities throughout the
pharmaceutical supply chain, including
manufacturers, to report these data to
CMS. An advantage of this approach is
that manufacturers could provide data
directly on total 340B units sold; in
other words, this data would capture the
limited 340B sales that the PVP data
does not capture. A disadvantage of this
approach is that not all manufacturers of
Part D rebatable drugs may have existing
mechanisms for tracking 340B sales for
Medicare Part D, which could
necessitate that new tracking and
reporting mechanisms be created. At
this time, CMS is not proposing this
alternative because CMS would prefer to
rely on data that are already reported to
the PVP, as using these data would help
to minimize reporting burdens and may
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result in cleaner and more accurate data
due to the quality checks performed on
the PVP data for purposes of compliance
with the 340B Program. For example,
audit and price integrity checks are
performed on the PVP data to ensure the
distributors submit and code the data
correctly.
To identify the total units sold to use
in the denominator of the estimation
percentage, CMS similarly considered
establishing a new requirement for other
entities throughout the pharmaceutical
supply chain, including manufacturers,
to report these data to CMS. An
advantage of this approach is that the
denominator would represent sales that
are ultimately dispensed in retail
community pharmacy settings and in
outpatient settings (whereas, as
mentioned previously, unit reporting
under the MDRP represents units
typically dispensed only in the retail
community pharmacy setting). A
disadvantage of this approach is that it
could necessitate that new tracking and
reporting mechanisms be created. At
this time, CMS is not proposing this
alternative as CMS believes that relying
upon existing manufacturer reporting of
unit sales reported with AMP under the
MDRP would be preferable to a new
reporting option and would help
minimize reporting burden. Further, the
use of unit sales reported with AMP
may provide cleaner and more accurate
data than establishing a new
manufacturer reporting requirement
since manufacturers must certify their
AMP reporting, in accordance with
§ 447.510(e), and are subject to civil
money penalties for false or inaccurate
reporting, in accordance with section
1927(b)(3)(B) of the Act. CMS also
considered using data on unit sales
available in a nationally representative
and commercially available database but
one disadvantage of this option would
be that CMS would be unable to audit
the quality of data available through
such a database.
(b) Comment Solicitation on a Medicare
Part D Claims Data Repository
In the initial Medicare Part D Drug
Inflation Rebate Guidance, CMS
solicited comments on the best
mechanism to identify 340B units
dispensed under Part D.587 CMS
discussed requiring the dispensing
entity to include a 340B claims
indicator on the Part D drug claim to be
included in PDE records. Many
commenters disagreed that the PDE
record was the most accurate way to
587 See: https://www.cms.gov/files/document/
medicare-part-d-inflation-rebate-program-initialguidance.pdf.
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identify 340B discounts for Part D
drugs. A few commenters highlighted
the operational challenges,
administrative burden, and potential for
increased dispensing fees and
reimbursement issues with both pointof-sale modifiers and retrospective 340B
identifiers. In addition, a wide array of
interested parties recommended that
CMS create a mechanism through which
covered entities would retrospectively
submit data to CMS identifying 340B
claims dispensed under Part D.
Interested parties urged that this
mechanism allow covered entities to
submit these data directly to CMS,
rather than through claims that
dispensers submit via Part D plan
sponsors.
In response to this feedback from
interested parties, CMS is soliciting
comments on establishing a Medicare
Part D claims data repository
(hereinafter, ‘‘repository’’) in a future
year of the Medicare Part D Drug
Inflation Rebate Program to comply with
the requirement under section 1860D–
14B(1)(B) of the Act that CMS shall
exclude from the total number of units
for a Part D rebatable drug those units
for which a manufacturer provides a
discount under the 340B Program. This
approach would require that covered
entities submit certain data elements
from 340B-identified Part D claims to
the repository. CMS solicits comments
on such a requirement later in this
section.
As described later in this section, a
repository could receive data elements
submitted by covered entities from
340B-identified claims for all drugs
covered under Medicare Part D billed to
Medicare. As requested by interested
parties in comments on the initial
Medicare Part D Drug Inflation Rebate
Guidance, the repository could allow
covered entities to submit these data
directly to CMS (or a contractor), rather
than through claims that dispensers
submit to Part D plan sponsors. CMS
could consider all data elements
received by the repository to be
associated with 340B-identified claims;
that is, the repository would not further
verify the 340B status of a claim but
rather would serve solely to store these
data. Under this process, CMS could
require an attestation from covered
entities that the data elements from all
claims submitted to the repository are
from verified 340B claims. CMS is
exploring approaches to confirming
completeness and accuracy of the
submission, and CMS is soliciting
comments on methods to review and
ensure the accuracy of reported data.
CMS could then match the stored data
elements to PDE records for each Part D
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rebatable drug dispensed during the
applicable period. Units associated with
PDE records that match to data elements
stored in the repository could be
considered those for which the
manufacturer provides a discount under
the 340B Program and therefore
removed from the total number of units
used to calculate the total rebate
amount.
(c) Comment Solicitation on Requiring
Covered Entities To Submit 340B
Claims Data to the Repository
CMS is soliciting comments on using
its authority under section 1860D–
14B(b)(1)(B) of the Act, as well as its
authorities under sections 1102(a) and
1871(a)(1) of the Act, to require covered
entities to enroll in a repository and
submit certain data elements from 340Bidentified claims for all covered Part D
drugs billed to Medicare to this
repository. CMS understands covered
entities typically contract with 340B
third-party administrators (340B TPAs)
to determine 340B eligibility of claims
using data submitted by covered entities
and their contract pharmacies.588 CMS
welcomes comments on whether or
how, to the extent a covered entity uses
a 340B TPA, CMS could require or
encourage TPAs to submit certain data
elements to the repository on behalf of
that covered entity.
Requiring covered entities to submit
data elements from 340B-identified Part
D claims to the repository could allow
CMS to receive data directly from the
entities that participate in the 340B
Program to identify 340B units to
exclude from Part D drug inflation
rebate calculations without
intermediary entities needing to develop
processes to capture these data and
relay it to CMS. CMS is considering
requiring covered entities to submit the
following data elements from Part D
claims for covered Part D drugs that are
purchased under the 340B Program and
dispensed to Medicare Part D
beneficiaries: (1) Date of Service (that is,
the date the prescription was filled by
the pharmacy); (2) Prescription or
Service Reference Number; (3) Fill
Number (that is, the code indicating
whether the prescription is an original
or a refill; if a refill, the code indicates
the refill number); and (4) Dispensing
Pharmacy NPI. CMS believes that these
would be the minimum data elements
required to match claims and remove
340B units from Part D drug inflation
rebate calculations. CMS is soliciting
588 Covered entities may elect to dispense 340B
drugs to patients through contract pharmacy
services, an arrangement in which the covered
entity enters a contract with the pharmacy to
provide pharmacy services.
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comments from interested parties on
this list of data elements and whether
these data elements would be accessible
to covered entities to submit to CMS.
(d) Comment Solicitation on Timing
Requirements for Potential Submissions
to a Medicare Part D Claims Data
Repository
CMS is soliciting comments on
requiring covered entities to submit the
fields specified by CMS to the
repository within 3 months of the end
of a given calendar quarter. For
example, for claims with dates of
service between October 1, 2027,
through December 31, 2027, covered
entities would be required to submit
data elements from 340B-identified
claims to CMS no later than March 31,
2028. The 340B units identified from
these quarterly submissions could be
removed from the total number of units
and total rebate amount specified in the
Preliminary Rebate Report and Rebate
Report detailed in proposed § 428.401(b)
and (c), respectively.
In accordance with the proposed
regulation at § 428.401(d) to reconcile
the rebate amount in the case of revised
information, including a reconciliation
of the total number of units detailed at
proposed § 428.401, CMS is soliciting
comments on providing covered entities
with additional time to submit data to
reflect a revision to the 340B
determination of claims with dates of
service throughout an applicable period.
A revision could come in one of two
forms: (1) resubmission of data for a
claim that the covered entity previously
submitted to a repository in error or
with errors in the requested data fields,
or (2) new submission of data for a
claim that the covered entity had
previously determined was not
purchased under the 340B Program, but
later identified was purchased under
such program. For the first type of
revision, CMS is soliciting comments on
requiring that the covered entity
resubmit the data from such claim using
a field to indicate that such data should
be removed from the repository’s dataset
of 340B-identified claims; if applicable,
the covered entity could resubmit the
claim with the correct information. CMS
is soliciting comments on the process
and timing for covered entities to
submit this revised data to the
repository after the end of the applicable
period. Updates to the total number of
units and total rebate amount based on
this revised information from covered
entities would be reflected in the
reconciliation process detailed at
proposed § 428.401(d).
CMS is soliciting comments from
interested parties on the feasibility of
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the proposed quarterly reporting
timeline for covered entities to submit
data elements from Part D 340B claims,
as well as the additional time to submit
data to reflect a revision to the 340B
determination of claims.
(e) Alternative Policy Considered: 340B
Claims Identifier
As described in section 40.2.7 of the
initial Medicare Part D Drug Inflation
Rebate Guidance, CMS considered
requiring that a 340B indicator be
included on the PDE record at the time
of dispense to identify drugs purchased
under the 340B Program that were
dispensed under Medicare Part D. As
described in the ‘‘Summary of Public
Comments on the Initial Medicare Part
D Drug Inflation Rebates Memorandum
and CMS’ Responses’’ in the revised
Medicare Part D Drug Inflation Rebate
Guidance, many commenters—
including covered entities, pharmacies,
Part D plan sponsors, and pharmacy
benefit managers—disagreed that the
PDE record would be the most accurate
way to identify 340B discounts for Part
D drugs. A few commenters highlighted
the operational challenges,
administrative burden, and potential for
increased dispensing fees and
reimbursement issues with 340B claim
identifiers. After further consideration
of comments received in response to the
initial guidance and of the process
through which a claim is determined to
have 340B status, CMS is no longer
pursuing this policy at this time but
may consider it in future rulemaking.
v. Treatment of New Formulations of
Part D Rebatable Drugs
Section 1860D–14B(b)(5)(B)(i) of the
Act requires CMS to determine a
formula for the rebate amount and the
inflation-adjusted payment amount for a
Part D rebatable drug that is a line
extension of a Part D rebatable drug that
is an oral solid dosage form for an
applicable period that is consistent with
the formula applied under section
1927(c)(2)(C) of the Act for determining
a rebate obligation for a rebate period
under such section. Section
1927(c)(2)(C) of the Act provides for an
alternative rebate calculation for line
extension drugs under the MDRP, and
CMS issued guidance on how this
calculation is performed for these
purposes.589
Section 1860D–14B(b)(5)(B)(ii) of the
Act further states that for a Part D
rebatable drug, the term line extension
589 See: https://www.medicaid.gov/medicaid/
prescription-drugs/medicaid-drug-rebate-program/
unit-rebate-calculation/unit-rebate-amountcalculation-for-line-extension-drugs-with-example/
index.html.
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means, ‘‘a new formulation of the drug,
such as extended release formulation,
but does not include an abuse-deterrent
formulation of the drug (as determined
by the Secretary), regardless of whether
such abuse-deterrent formulation is an
extended release formulation.’’ This
language is identical to the definition of
‘‘line extension’’ in section 1927(c)(2)(C)
of the Act. Regulatory definitions of
‘‘line extension’’ and ‘‘new formulation’’
for the MDRP were adopted through
rulemaking 590 and can be found at
§ 447.502. In alignment with CMS’
policy in section 40.4 of the revised
Medicare Part D Drug Inflation Rebate
Guidance, CMS proposes in § 428.200 to
adopt the definitions of ‘‘line extension’’
and ‘‘new formulation’’ at § 447.502 of
this title for the purposes of identifying
new formulations of Part D rebatable
drugs.
In proposed § 428.204, CMS would
determine the total rebate amount to be
paid by manufacturers by taking the
greater of (1) the total rebate amount
calculated in proposed § 428.201(a) for
the applicable period for the Part D
rebatable drug that is a line extension,
or (2) the alternative total rebate
amount. This proposal is a modification
to policy established in revised
Medicare Part D Drug Inflation Rebate
Guidance. While the revised guidance
stated that CMS would compare the per
unit rebate amount to the alternative per
unit rebate amount, as proposed in
§ 428.204, CMS would compare the total
rebate amount calculated in proposed
§ 428.201(a) to the alternative total
rebate amount, which CMS believes is
consistent with the existing regulations
for new formulations at § 447.509(a)(4).
CMS further proposes in § 428.204 to
codify the policy described in section
40.4 of the revised guidance to calculate
the alternative inflation rebate amount
for a Part D rebatable drug that is a line
extension consistent with the formula
applied under section 1927(c)(2)(C) of
the Act. That is, CMS would determine
an inflation rebate amount ratio for the
initial drug identified by the
manufacturer in accordance with
§ 447.509(a)(4)(i)(B) by dividing the
inflation rebate amount for that initial
drug for the applicable period by the
AnMP for that initial drug for the
applicable period, as calculated under
proposed § 428.202(b).
To identify the initial drug for the line
extension, CMS would use information
from the Medicaid Drug Program system
and identify line extensions based on
manufacturer reporting of drugs as line
extensions and related pricing and
product data in that system. CMS notes
590 See:
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that Medicaid rebates are calculated
quarterly, and a different initial drug
may be identified in different quarters
by the manufacturer for a particular line
extension drug. Part D drug inflation
rebates are calculated based on a 12month applicable period, meaning there
may be instances where a Part D
rebatable line extension drug has
multiple potential initial drugs during
the applicable period that could be used
for the alternative inflation rebate
amount calculation. In such situations,
for consistency, CMS will use the initial
drug identified by the manufacturer in
the last quarter of the Part D inflation
rebate applicable period to identify the
initial drug for the line extension drug
alternative inflation rebate calculation.
If an initial drug was not identified in
the last quarter for a drug that is a line
extension, CMS will use the initial drug
identified for a quarter most recently in
that applicable period to identify the
initial drug for the line extension drug
alternative inflation rebate calculation.
d. Reducing the Rebate Amount for Part
D Rebatable Drugs in Shortage and
When There Is a Severe Supply Chain
Disruption or Likely Shortage
(§§ 428.300 Through 428.303)
Section 1860D–14B(b)(1)(C) of the Act
requires the Secretary to reduce or
waive the rebate amount owed by a
manufacturer for a Part D rebatable drug
with respect to an applicable period in
three distinct cases: (1) when a Part D
rebatable drug is described as currently
in shortage on a shortage list in effect
under section 506E of the FD&C Act at
any point during the applicable period;
(2) when CMS determines there is a
severe supply chain disruption during
the applicable period for a generic Part
D rebatable drug or biosimilar, such as
Drug Shortage
Duration of
Reduction
Indefinite for as long as drug is "currently in
shortage"
Percent Reduction
Part D rebatable
drug other than a
plasma-derived
product or generic
Part D rebatable
drug
25%
First applicable
period
Second applicable
period
Subsequent applicable
periods
Part D rebatable
plasma-derived
product or generic
Part D rebatable drug
a disruption caused by a natural disaster
or other unique or unexpected event;
and (3) when CMS determines that
without such a reduction or waiver, a
generic Part D rebatable drug is likely to
be described as in shortage on such
shortage list during a subsequent
applicable period. The statute does not
describe how CMS should reduce or
waive inflation rebates.
To implement the statutory
requirement under section 1860D–
14B(b)(1)(C), CMS proposes to codify in
subpart D of part 428 existing policies
described in sections 40.5, 40.5.1,
40.5.2, and 40.5.3 of the revised
Medicare Part D Drug Inflation Rebate
Guidance to reduce the total rebate
amount owed by a manufacturer in each
of these three cases, as summarized in
Table 51 and discussed later in this
section.
Severe Supply Chain
Likely to J:ld.~
Disruption
Shortage
One applicable period; manufacturer may
request an extension for an additional
applicable period for up to two applicable
periods total
Part D rebatable
Generic Part D
biosimilar or generic
rebatable drug
Part D rebatable drug
75%
75%
75%
10%
50%
75%
75%
2%
25%
Not applicable
Not applicable
As proposed, CMS would not fully
waive the rebate amount owed in any
case. CMS believes the proposed rebate
reduction policies balance providing
appropriate financial relief for
manufacturers in certain circumstances,
including when there is a severe supply
disruption resulting from exogenous
circumstances outside of a
manufacturer’s control, while not
incentivizing manufacturers to delay
taking appropriate steps to resolve a
drug shortage or severe supply chain
disruption, or maintain a situation in
which a generic would be at risk of
shortage to avoid an obligation to pay
rebates. CMS will continue to evaluate
these policies and may update them in
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future years. CMS underscores that most
shortages involve multiple source
generic drugs,591 which are not Part D
rebatable drugs and thus are not subject
to Part D drug inflation rebates. CMS
solicits comments on the proposed
approach.
i. Definitions
CMS proposes in § 428.300 to define
the following terms applicable to
subpart D (§§ 428.300 through 428.303):
• ‘‘Biosimilar’’.
• ‘‘Drug shortage’’ or ‘‘shortage’’.
• ‘‘Generic Part D rebatable drug’’.
https://www.iqvia.com/insights/the-iqviainstitute/reports-and-publications/reports/drugshortages-in-the-us2023.
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• ‘‘Likely to be in shortage’’.
• ‘‘Plasma-derived product’’.
Proposed § 428.300 also would codify
definitions established in the revised
Medicare Part D Drug Inflation Rebate
Guidance for the following terms:
• ‘‘Currently in shortage’’.
• ‘‘Natural disaster’’.
• ‘‘Other unique or unexpected
event’’.
• ‘‘Severe supply chain disruption’’.
ii. Reducing the Rebate Amount for Part
D Rebatable Drugs Currently in Shortage
In proposed § 428.301, CMS proposes
to codify the policy established in
section 40.5.1 of the revised Medicare
Part D Drug Inflation Rebate Guidance
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whereby CMS would reduce the total
rebate amount for a Part D rebatable
drug that is currently in shortage based
on the length of time the drug is in
shortage during an applicable period
and decrease the amount of the
reduction over time. CMS intends to use
the shortage lists maintained by the
FDA Center for Biologics Evaluation and
Research (CBER) and Center for Drug
Evaluation and Research (CDER) to
determine whether a Part D rebatable
drug is currently in shortage 592 during
an applicable period. CMS will not
consider an NDC–10 in the status of ‘‘to
be discontinued,’’ ‘‘discontinued,’’ or
‘‘resolved’’ to be ‘‘currently in
shortage.’’ At this time, CMS intends to
provide the same reduction in the rebate
amount for Part D rebatable drugs
currently in shortage regardless of the
cause of the shortage.
CMS will not provide a full waiver of
the rebate amount for drugs currently in
shortage on an FDA shortage list, as
providing a full waiver of the rebate
amount could further incentivize
manufacturers to delay taking
appropriate steps that may resolve a
shortage more expeditiously simply to
maintain having the drug listed on
FDA’s drug shortage list to avoid an
obligation to pay rebates for an extended
period. Further, in a report analyzing
the root causes of drug shortages
between 2013 and 2017, FDA found that
more than 60 percent of drug shortages
were the result of manufacturing or
product quality issues, and providing a
full waiver of the rebate amount in
situations that may be within a
manufacturer’s control could be
perceived as rewarding manufacturers
for poor quality management.593
CMS would be responsible for
monitoring the status of a Part D
rebatable drug on an FDA shortage list,
and manufacturers would not need to
submit any information to CMS to be
eligible for a reduction of the rebate
amount for a Part D rebatable drug that
is currently in shortage.
To calculate the reduced total rebate
amount for a Part D rebatable drug, in
§ 428.301(b)(1), CMS proposes the
following formula:
Reduced Total Rebate Amount = the
total rebate amount multiplied by (1
minus applicable percent
reduction) multiplied by
(percentage of time drug was
592 For the purposes of this proposed rule, CMS
uses the term ‘‘currently in shortage’’ to refer to Part
D rebatable drugs that are in the status of ‘‘currently
in shortage’’ on the CDER shortage list, as well as
biological products listed on CBER’s current
shortages list.
593 See: https://www.fda.gov/media/131130/
download?attachment#page=33.
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currently in shortage during the
applicable period) added to the
total rebate amount multiplied by (1
minus percentage of time drug was
currently in shortage during the
applicable period)
For the purpose of this formula, for a
Part D rebatable drug that is a generic
drug or a plasma-derived product, in
§ 428.301(b)(2)(i), CMS proposes an
applicable percent reduction of 75
percent for the first applicable period
such Part D rebatable drug is currently
in shortage, 50 percent for the second
applicable period, and 25 percent for
each subsequent applicable period. For
a Part D rebatable drug (including a
biosimilar) that is not a generic drug or
a plasma-derived product, in
§ 428.301(b)(2)(ii), CMS proposes an
applicable percent reduction of 25
percent for the first applicable period
such Part D rebatable drug is currently
in shortage, 10 percent for the second
applicable period, and 2 percent for
each subsequent applicable period.
Because drugs and biologicals on the
FDA shortage lists are maintained at the
NDC–10 level, and Part D drug inflation
rebates are calculated at the NDC–9
level, CMS proposes in § 428.301(c) that
if any NDC–10 for a Part D rebatable
drug is currently in shortage, CMS
would apply the rebate reduction to the
entire Part D rebatable drug at the NDC–
9 level. CMS will closely monitor
market data for the Part D rebatable
drugs for which the rebate is reduced to
ensure the integrity of the application of
the rebate reduction policy.
CMS intends to provide a reduction in
the rebate amount for as long as a Part
D rebatable drug is currently in
shortage. CMS believes the rebate
reduction should be proportional to the
time the drug is currently in shortage
and decrease over time to balance
providing financial relief to
manufacturers experiencing a drug
shortage while not incentivizing
manufacturers to delay taking
appropriate steps to resolve a shortage
simply to maintain having the drug
listed on an FDA shortage list to avoid
an obligation to pay rebates for an
extended period.
To determine the percentage of time
a Part D rebatable drug was currently in
shortage during the applicable period,
as proposed in § 428.301(b)(3), CMS
would count the number of days such
drug is currently in shortage in an
applicable period and divide by the
total number of days in that applicable
period.
In proposed § 428.301(b)(2), CMS
proposes codifying the policy set forth
in section 40.5.1 of the revised Medicare
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Part D Drug Inflation Rebate Guidance
to apply a greater applicable percent
reduction for generic Part D rebatable
drugs, which, by definition, are sole
source generic drugs, compared to
brand-name drugs and biologicals,
including biosimilars. CMS understands
that generic drugs are often low-margin
products whose prices are tied to the
marginal cost of production and thus are
vulnerable to potential market exit and
shortage when input costs increase.
CMS notes that the Medicare Part D
Drug Inflation Rebate Program does not
apply to multiple source generic drugs,
which are the generic drugs most likely
to be in shortage.594 CMS proposes also
applying a greater applicable percent
reduction for plasma-derived products
than non-plasma derived products
because the former rely on a variable
supply of donated blood plasma that
can impact downstream production and
therefore hamper the ability to promptly
resolve a shortage.
When the status of a Part D rebatable
drug changes from currently in shortage
to ‘‘resolved’’ and either remains in the
status of ‘‘resolved’’ or is removed from
the list, and then reemerges on the list
in the status of currently in shortage in
the next applicable period, CMS would
apply the shortage reduction as if there
was a continuous shortage and move to
the applicable percent reduction for the
second applicable period. (In this
scenario, the applicable percent
reduction would be 50 percent for the
second applicable period for a generic
Part D rebatable drug or plasma-derived
product and 10 percent for a Part D
rebatable drug that is not a generic drug
or plasma-derived product.) When the
status of a Part D rebatable drug changes
from currently in shortage to ‘‘resolved’’
and either remains in the status of
‘‘resolved’’ or is removed from the list
for at least one applicable period, and
then subsequently reemerges on a
shortage list, the subsequent shortage
would be treated as a new shortage. In
such case, the applicable percent
reduction for the first applicable period
in which the drug reemerges on the
shortage list would be 75 percent for a
generic Part D rebatable drug or plasmaderived product and 50 percent for a
Part D rebatable drug that is not a
generic or plasma-derived product.
594 See: https://www.iqvia.com/insights/the-iqviainstitute/reports-and-publications/reports/drugshortages-in-the-us2023.
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iii. Reducing the Rebate Amount for
Generic Part D Rebatable Drugs and
Biosimilars When There Is a Severe
Supply Chain Disruption
In § 428.302 of this proposed rule,
CMS proposes to codify existing policy
established in section 40.5.2 of the
revised Medicare Part D Drug Inflation
Rebate Guidance for rebate reductions
when CMS determines there is a severe
supply chain disruption during an
applicable period. As proposed in
§ 428.302(b)(1), CMS would provide a
time-limited standard reduction of 75
percent in the total rebate amount for a
generic Part D rebatable drug or
biosimilar when CMS determines there
is a severe supply chain disruption
during the applicable period, such as
that caused by a natural disaster or other
unique or unexpected event. To receive
a rebate reduction in accordance with
proposed § 428.302(b)(1), the
manufacturer would have to submit to
CMS a rebate reduction request 595 that
meets the eligibility requirements
proposed in § 428.302(c). A rebate
reduction request should specify each
NDC–11 to which the request applies,
and if CMS grants a manufacturer’s
severe supply chain disruption rebate
reduction request for an NDC–11, CMS
proposes in § 428.302(b)(3) that the
rebate reduction would apply to the
entire generic Part D rebatable drug or
biosimilar at the NDC–9 level. CMS has
proposed additional submission
requirements for rebate reduction
requests in the information collection
request under OMB control number:
0938–NEW (CMS–10858).
As proposed in § 428.302(c)(4), CMS
would grant a reduction in the rebate
amount owed if a manufacturer of an
eligible drug submits to CMS a request
in writing demonstrating that (1) a
severe supply chain disruption has
occurred during the applicable period,
(2) the severe supply chain disruption
directly affects the manufacturer itself, a
supplier of an ingredient or packaging,
a contract manufacturer,596 or a method
of shipping or distribution that the
manufacturer uses in a significant
595 The rebate reduction request forms are
currently going through the Paperwork Reduction
Act approval process under the document identifier
CMS–10858. The proposed collection was
published for a 30-day comment period in the June
3, 2024 Federal Register (89 FR 47563).
596 A contract manufacturer is a party that
performs one or more manufacturing operations on
behalf of a manufacturer(s) of active pharmaceutical
ingredients (APIs), drug substances, in-process
materials, finished drug products, including
biological products, and combination products. See
‘‘Contract Manufacturing Arrangements for Drugs:
Quality Agreements Guidance for Industry,’’
November 2016: https://www.fda.gov/media/86193/
download.
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capacity to make or distribute the
generic Part D rebatable drug or
biosimilar, and (3) the severe supply
chain disruption was caused by a
natural disaster or other unique or
unexpected event. CMS will begin
accepting rebate reduction requests and
rebate reduction extension requests
upon completion of the Paperwork
Reduction Act (PRA) process, including
for severe supply chain disruptions
caused by a natural disaster or other
unique or unexpected event that
occurred on or after October 1, 2022, but
before to completion of the PRA
process. As proposed in § 428.302(c)(2),
for a natural disaster or other unique or
unexpected event occurring on or after
August 2, 2024, that the manufacturer
believes caused a severe supply chain
disruption, the manufacturer must
submit the rebate reduction request
within 60 calendar days from the first
day that the natural disaster or other
unique or unexpected event occurred or
began in order for CMS to consider a
rebate reduction.
If the manufacturer makes a timely
request that includes all the supporting
documentation, and CMS determines,
based on its review of the reduction
request and supporting documentation,
that a reduction should be granted, CMS
would reduce the total rebate amount
owed by a manufacturer by 75 percent
for the manufacturer’s generic Part D
rebatable drug or biosimilar for the
applicable period in which the event
that caused the severe supply chain
disruption occurred or began or, the
following applicable period if the
request is submitted less than 60
calendar days before the end of an
applicable period. CMS acknowledges
that the 60-day advance submission
requirement may pose a challenge to
timing of the rebate reduction when the
severe supply chain disruption-causing
event occurs late in one applicable
period, and the request is not submitted
until the next applicable period. In such
circumstances, CMS would apply a
rebate reduction to an applicable period
based on the timing of the natural
disaster or other unique or unexpected
event causing a severe supply chain
disruption and the timing of the
submission of the request and may
adjust the timing of the application of
the rebate reduction as appropriate to
meet the invoicing deadlines specified
in statute and subpart E of proposed
part 428.
CMS proposes in § 428.302(c)(5) that
if a manufacturer believes severe supply
chain disruption continues into a
second, consecutive applicable period
after the start of the natural disaster or
other unique or unexpected event, the
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61975
manufacturer may request a reduction of
the total rebate amount for that second
applicable period by submitting a rebate
reduction extension request to CMS,
along with any new supporting
documentation. CMS has proposed
additional submission requirements for
rebate reduction extension requests in
the information collection request under
OMB control number: 0938–NEW
(CMS–10858). As proposed in
§ 428.302(c)(5)(ii), a rebate reduction
extension request and any new
supporting documentation must be
submitted at least 60 calendar days
before the start of that second applicable
period in order for CMS to consider a
rebate reduction extension, except for
when the initial request is made less
than 60 calendar days before the end of
an applicable period such that the
initial rebate reduction applied to the
next applicable period rather than the
applicable period in which the event
that caused the severe supply chain
disruption occurred or began. In these
cases, the rebate reduction extension
request must be submitted at least 60
calendar days prior to the end of the
applicable period in which the initial
reduction applied.
If the manufacturer submits a
complete and timely extension request,
and CMS determines that the
information submitted warrants an
extension of the rebate reduction, the
total rebate amount would be reduced
by 75 percent for a second consecutive
applicable period for that
manufacturer’s generic Part D rebatable
drug or biosimilar in accordance with
proposed § 428.302(b)(2).
Consistent with the policy established
in section 40.5.2 of the revised Medicare
Part D Drug Inflation Rebate Guidance,
a manufacturer may receive only one
extension of the rebate reduction per
generic Part D rebatable drug or
biosimilar per CMS determination of a
severe supply chain disruption, as
proposed in § 428.302(c)(5). Said
differently, CMS would limit the severe
supply chain disruption rebate
reduction to two consecutive applicable
periods total per generic Part D
rebatable drug or biosimilar per CMS
determination of a severe supply chain
disruption.
As proposed in § 428.302(b)(4)(i), if
the manufacturer believes there are
multiple events causing severe supply
chain disruptions during the same
applicable period for the same generic
Part D rebatable drug or biosimilar and
submits multiple rebate reduction
requests for the same generic drug or
biosimilar, CMS will grant no more than
one rebate reduction for that generic
drug or biosimilar for the applicable
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period. For example, if the manufacturer
of a generic Part D rebatable drug or
biosimilar is granted a severe supply
chain disruption rebate reduction
request for its product due to a natural
disaster that occurred in January 2025
and then experiences a second severe
supply chain disruption caused by a
second, distinct natural disaster in July
2025, CMS would not grant the second
rebate reduction request. That is, the
manufacturer would receive the 75
percent reduction for one applicable
period for the severe supply chain
disruption caused by the first natural
disaster but would not receive a rebate
reduction for the second natural
disaster. However, if the second natural
disaster exacerbated the severe supply
chain disruption caused by the first
natural disaster, the manufacturer may
reflect such circumstances in its request
for an extension of the rebate reduction
for a second applicable period.
As proposed in § 428.302(b)(4)(ii), if
CMS grants a severe supply chain
disruption rebate reduction request for a
generic Part D rebatable drug or
biosimilar, and the drug or biosimilar
appears as currently in shortage during
the same applicable period as the one
for which the severe supply chain
disruption reduction request was
granted, CMS would apply the 75
percent reduction to the entire
applicable period for which the severe
supply disruption request was granted
and would not grant any additional
reduction for the shortage status during
that applicable period. For any
subsequent applicable periods that the
generic Part D rebatable drug or
biosimilar appears as currently in
shortage, CMS would reduce the total
rebate amount in accordance with the
drug shortages reduction proposed in
§ 428.301, starting with the highest
reduction (that is, 75 percent for a
generic Part D rebatable drug or plasmaderived product and 25 percent for a
Part D rebatable drug that is not a
generic drug or plasma-derived
product). For example, if CMS grants a
severe supply chain disruption rebate
reduction request for a generic Part D
rebatable drug or biosimilar that was
submitted on November 15, 2024, and
that generic Part D rebatable drug or
biosimilar is currently in shortage from
September 15, 2025, until May 15, 2026,
CMS would apply a 75 percent
reduction in the total rebate amount for
the duration of the applicable period for
which the severe supply chain
disruption rebate reduction request was
granted (that is, October 1, 2024, to
September 30, 2025), and then would
apply the shortages reduction as
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proposed in § 428.301, beginning with a
reduction of 25 percent for a biosimilar
or 75 percent for a generic Part D
rebatable drug or plasma-derived
product that is a biosimilar for the
applicable period beginning October 1,
2025.
As proposed in § 428.302(b)(4)(iii), if
a generic Part D rebatable drug or
biosimilar that is currently in shortage
experiences a severe supply chain
disruption, the manufacturer may
submit a severe supply chain disruption
rebate reduction request. If CMS grants
the rebate reduction request, the rebate
amount would be reduced by 75 percent
for the applicable period, and CMS
would not grant any additional
reduction under proposed § 428.301 for
the currently in shortage status during
that applicable period. For example, if
a generic Part D rebatable drug or
biosimilar that is currently in shortage
in the applicable period beginning
October 1, 2024 is granted a severe
supply chain disruption rebate
reduction request as a result of a natural
disaster that occurs on April 5, 2025,
CMS would apply a 75 percent
reduction in the rebate amount for the
duration of the applicable period in
which the natural disaster occurred
(that is, October 1, 2024, to September
30, 2025). In this same example, if the
natural disaster instead occurs on
September 5, 2025, CMS would apply
the shortages reduction proposed in
§ 428.301 for the duration of the
applicable period beginning October 1,
2024 (that is, October 1, 2024, to
September 30, 2025), and then a 75
percent reduction under the severe
supply chain disruption policy to the
next applicable period beginning
October 1, 2025 (that is, October 1,
2025, to September 30, 2026).
In § 428.302(c)(6), CMS proposes to
review rebate reduction requests and
rebate reduction extension requests
within 60 calendar days of receipt of all
documentation, if feasible, beginning
with the applicable period that begins
on October 1, 2024. If a manufacturer’s
rebate reduction request does not meet
the criteria in proposed § 428.302(c)(4)
or if the rebate reduction request is
incomplete or untimely based on the
requirements in proposed § 428.302(c),
CMS would deny the request. CMS also
proposes that if a manufacturer’s rebate
reduction extension request does not
meet the criteria in proposed
§ 428.302(c)(5), is incomplete or
untimely based on the requirements in
proposed § 428.302(c)(5), or if a
reduction under proposed
§ 428.302(b)(1) was not provided for
such generic Part D rebatable drug or
biosimilar, CMS would deny the rebate
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reduction extension request. As
proposed in § 428.302(c)(6)(iii), CMS’
decisions to deny a request would be
final and not be subject to an appeals
process.
As proposed at § 428.302(c)(7), CMS
would keep confidential, to the extent
allowable under law, any requests for a
rebate reduction, including supporting
documentation. CMS proposes that
information provided as part of a severe
supply chain disruption rebate
reduction request that the submitter
indicates is a trade secret or confidential
commercial or financial information
would be protected from disclosure if
CMS determines the information meets
the requirements set forth under
Exemptions 3 or 4 of the Freedom of
Information Act (FOIA). In addition to
the protections under the FOIA for trade
secrets and commercial or financial
information obtained from a person that
is privileged or confidential, the Trade
Secrets Act at 18 U.S.C. 1905 requires
executive branch employees to protect
such information. CMS would protect
confidential and proprietary
information as required by applicable
law.
iv. Reducing the Rebate Amount for
Generic Part D Rebatable Drugs Likely
To Be in Shortage
In § 428.303 of this proposed rule,
CMS proposes to codify existing policy
established in section 40.5.3 of the
revised Medicare Part D Drug Inflation
Rebate Guidance for rebate reductions
when a generic Part D rebatable drug is
likely to be in shortage, as defined in
proposed § 428.300. As proposed in
§ 428.303(b)(1), CMS would provide a
time-limited standard reduction of 75
percent in the total rebate amount for a
generic Part D rebatable drug when CMS
determines that the generic Part D
rebatable drug is likely to be in shortage.
To receive a rebate reduction in
accordance with proposed
§ 428.303(b)(1), the manufacturer would
have to submit to CMS a rebate
reduction request 597 that meets the
eligibility requirements proposed in
§ 428.303(c). A rebate reduction request
should specify each NDC–11 to which
the request applies and if CMS grants a
manufacturer’s likely to be in shortage
rebate reduction request for an NDC–11,
CMS proposes in § 428.303(b)(3) that the
rebate reduction would apply to the
entire generic Part D rebatable drug at
the NDC–9 level. CMS has proposed
597 The rebate reduction request forms are
currently going through the Paperwork Reduction
Act approval process under the document identifier
CMS–10858. The proposed collection was
published for a 30-day comment period in the June
3, 2024 Federal Register (89 FR 47563).
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additional submission requirements for
rebate reduction requests in the
information collection request under
OMB control number: 0938–NEW
(CMS–10858).
As proposed in § 428.303(c)(4), CMS
would grant a reduction in the rebate
amount owed if a manufacturer of an
eligible drug submits to CMS a request
in writing demonstrating that (1) the
generic Part D rebatable drug is likely to
be in shortage, (2) the manufacturer is
taking actions to avoid the potential
drug shortage, and (3) the reduction of
the rebate amount would reduce the
likelihood of the drug appearing on an
FDA shortage list. As proposed in
§ 428.303(c)(2), a manufacturer must
submit the rebate reduction request
before the start of the next applicable
period in which the manufacturer
believes the generic Part D rebatable
drug is likely to be in shortage in order
for CMS to consider a rebate reduction.
If the manufacturer makes a timely
request that includes all the supporting
documentation, and CMS determines,
based on its review of the reduction
request and supporting documentation,
that a reduction should be granted, CMS
would reduce the total rebate amount
owed by a manufacturer by 75 percent
for the manufacturer’s generic Part D
rebatable drug for the applicable period
in which the request was submitted or
the following applicable period,
depending on the timing of the
submission of the request.
CMS proposes in § 428.303(c)(5) that
if a manufacturer believes the potential
drug shortage continues for a second,
consecutive applicable period, the
manufacturer may request a reduction of
the total rebate amount for that second
applicable period by submitting a rebate
reduction extension request to CMS,
along with any new supporting
documentation. CMS has proposed
additional submission requirements for
rebate reduction extension requests in
the information collection request under
OMB control number: 0938–NEW
(CMS–10858). As proposed in
§ 428.303(c)(5)(ii), a rebate reduction
extension request and any new
supporting documentation must be
submitted at least 60 calendar days
before the start of the second applicable
period in which the manufacturer
believes the generic Part D rebatable
drug is likely to be in shortage in order
for CMS to consider a rebate reduction
extension.
If the manufacturer submits a
complete and timely extension request,
and CMS determines that the
information submitted warrants an
extension of the rebate reduction, the
total rebate amount would be reduced
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by 75 percent for a second consecutive
applicable period for that
manufacturer’s generic Part D rebatable
drug in accordance with proposed
§ 428.303(b)(2).
Consistent with the policies
established in section 40.5.3 of the
revised Medicare Part D Drug Inflation
Rebate Guidance, a manufacturer may
receive only one extension of the rebate
reduction per generic Part D rebatable
drug per CMS determination of
likelihood of shortage, as proposed in
§ 428.303(c)(5). Said differently, CMS
would limit the likely to be in shortage
rebate reduction to two consecutive
applicable periods total per generic Part
D rebatable drug per CMS determination
of likelihood of shortage.
As proposed in § 428.303(b)(4), if
CMS grants a rebate reduction request
for a generic Part D rebatable drug that
is likely to be in shortage, and the drug
appears as currently in shortage during
the same applicable period as the one
for which the likely to be in shortage
reduction request was granted, CMS
would apply the 75 percent reduction to
the entire applicable period for which
the likely to be in shortage request was
granted and would not grant any
additional reduction for the shortage
status during that applicable period. For
any subsequent applicable periods that
the generic Part D rebatable drug
appears as currently in shortage, CMS
would reduce the total rebate amount in
accordance with the drug shortages
reduction proposed in § 428.301,
starting with the highest reduction (that
is, 75 percent for a generic Part D
rebatable drug). For example, if CMS
grants a likely to be in shortage rebate
reduction request for a generic Part D
rebatable drug that was submitted on
August 15, 2024, and that generic Part
D rebatable drug is currently in shortage
from September 15, 2025, until May 15,
2026, CMS would apply a 75 percent
reduction in the total rebate amount for
the duration of the applicable period for
which the likely to be in shortage rebate
reduction request was granted (that is,
October 1, 2024, to September 30, 2025),
and then would apply the shortages
reduction as proposed in § 428.301,
beginning with a reduction of 75
percent for a generic Part D rebatable
drug for the applicable period beginning
October 1, 2025.
If the manufacturer of a generic Part
D rebatable drug that is currently in
shortage believes such generic drug is
likely to continue to be in shortage in
the next applicable period, the
manufacturer may submit a likely to be
in shortage rebate reduction request to
CMS. If the request meets the criteria
described in proposed in
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61977
§ 428.303(c)(4), CMS would reduce the
total rebate amount owed by a
manufacturer by 75 percent for the
manufacturer’s generic Part D rebatable
drug. Consistent with the evaluation
criteria proposed in § 428.303(c)(4),
CMS does not intend to consider a
generic Part D rebatable drug as likely
to be in shortage based solely upon the
drug being currently in shortage.
However, if the manufacturer believes
there are circumstances that may
exacerbate the current shortage such
that without the reduction the generic
Part D rebatable drug is likely to be in
shortage in the next applicable period,
the manufacturer may reflect such
circumstances in its rebate reduction
request. For example, if a generic Part D
rebatable drug is currently in shortage
during the applicable period beginning
October 1, 2023 because the
manufacturer had trouble meeting
demand for the drug and then in August
2024, the manufacturer faces difficulties
securing the API for such drug and
believes this may worsen the shortage
situation and result in the generic Part
D rebatable drug being currently in
shortage in the next applicable period,
the manufacturer may submit a likely to
be in shortage rebate reduction request
to CMS providing information on the
severity of the likely shortage. CMS
welcomes comments on this approach.
In § 428.303(c)(6), CMS proposes to
review rebate reduction requests and
rebate reduction extension requests
within 60 calendar days of receipt of all
documentation, if feasible, beginning
with the applicable period that begins
on October 1, 2024. If a manufacturer’s
rebate reduction request does not meet
the criteria in proposed § 428.303(c)(4)
or if the rebate reduction request is
incomplete or untimely based on the
requirements in proposed § 428.303(c),
CMS would deny the request. CMS also
proposes that if a manufacturer’s rebate
reduction extension request does not
meet the criteria in proposed
§ 428.303(c)(5), is incomplete or
untimely based on the requirements in
proposed § 428.303(c)(5), or if a
reduction under proposed
§ 428.303(b)(1) was not provided for
such generic Part D rebatable drug, CMS
would deny the rebate reduction
extension request. As proposed in
§ 428.303(c)(6)(iii), CMS’ decisions to
deny a request would be final and not
be subject to an appeals process.
As proposed at § 428.303(c)(7), CMS
would keep confidential, to the extent
allowable under law, any requests for a
rebate reduction, including supporting
documentation. CMS proposes that
information provided as part of a likely
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to be in shortage rebate reduction
request that the submitter indicates is a
trade secret or confidential commercial
or financial information would be
protected from disclosure if CMS
determines the information meets the
requirements set forth under
Exemptions 3 or 4 of FOIA. In addition
to the protections under the FOIA for
trade secrets and commercial or
financial information obtained from a
person that is privileged or confidential,
the Trade Secrets Act at 18 U.S.C. 1905
requires executive branch employees to
protect such information. CMS would
protect confidential and proprietary
information as required by applicable
law.
e. Reports of Rebate Amounts,
Reconciliation, Suggestion of Error, and
Payments (§§ 428.400 Through 428.405)
Section 1860D–14B(a)(1) of the Act
requires the Secretary to report to each
manufacturer of a Part D rebatable drug
the following information not later than
9 months after the end of the applicable
period: (1) the amount, if any, of the
excess AnMP increase described in
section 1860D–14B(b)(1)(A)(ii) for each
Part D rebatable drug and (2) the rebate
amount for each Part D rebatable drug.
In compliance with section 1860D–
14B(a)(2) of the Act, the manufacturer of
a Part D rebatable drug must provide a
rebate for each Part D rebatable drug no
later than 30 calendar days after the
receipt of the information provided by
the Secretary in section 1860D–
14B(a)(1) of the Act.
To fulfill this statutory requirement,
CMS proposes to send a Preliminary
Rebate Report followed by a Rebate
Report, as described in proposed
§ 428.401(b) and (c), to all
manufacturers of a Part D rebatable
drug, even if the amount due is $0; all
rebate amounts would be subject to
reconciliation as proposed in
§ 428.401(d). As proposed in
§ 428.401(b), CMS does not intend to
send notice to manufacturers for drugs
that are not considered rebatable
pursuant to proposed § 428.20.
Additionally, section 1860D–
14B(b)(6) states that CMS shall provide
a method and process under which CMS
adjusts the calculation of the rebate
amount for a Part D rebatable drug for
an applicable period if CMS determines
such an adjustment is necessary based
on revisions to the number of units of
a rebatable covered Part D drug
dispensed submitted by a PDP sponsor
of a prescription drug plan or an MA
organization offering an MA–PD plan.
The statute also specifies that CMS must
reconcile any underpayments in the
rebate amount paid by the manufacturer
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of the applicable Part D rebatable drug
due to such an adjustment and
underpayments must be paid no later
than 30 days from the date of receipt of
information from CMS about the
adjustment. To fulfill this statutory
obligation and to address the
completeness and accuracy of the rebate
amount, CMS proposes to conduct
regular reconciliations at two points in
time to determine whether the rebate
amount must be adjusted due to
updated claims and payment data used
in the calculation of such rebate amount
(specified in proposed § 428.401(d)(1)):
(1) 12 months after the issuance of the
Rebate Report, and (2) 36 months after
the issuance of the Rebate Report. The
reporting process for each reconciliation
will be the same process described for
the original Rebate Report, with
payment due for any outstanding rebate
amount 30 days after receipt of a report
with a reconciled rebate amount. In
addition to regular reconciliations, CMS
proposes a process to conduct
reconciliations of the rebate amount as
needed to correct agency error and
when CMS determines that the
information used by CMS to calculate a
rebate amount was inaccurate due to
manufacturer misreporting.
i. Definitions
In proposed § 428.400, CMS proposes
to define the following term applicable
to subpart E (§§ 428.400 through
428.405):
• ‘‘Date of receipt’’.
For example, if CMS issues a Rebate
Report through the method and process
described in proposed § 428.404 on June
30, 2026, then July 1, 2026, will be the
date of receipt and day one of the 30calendar-day payment period.
ii. Reports of Rebate Amounts and
Suggestion of Error
Consistent with the process specified
in section 50 of the revised Medicare
Part D Drug Inflation Rebate Guidance
involving preliminary and final reports,
CMS proposes to codify a multi-step
process to provide a manufacturer as
defined in proposed § 428.20 with the
rebate information specified under
section 1860D–14B(a) of the Act. CMS
considered the following factors in
determining a method and process for
providing the rebate information:
meeting statutorily provided deadlines
in section 1860D–14B(a) of the Act (for
example, dates by which to provide the
rebate amount owed to the
manufacturer); the operational time to
acquire the relevant information
specified in proposed part 428; the
operational time to calculate the rebate
amount specified in subparts B and C of
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proposed part 428; clarity of the
information provided as well as
potential burden on manufacturers; and
how to ensure the accuracy of the rebate
amount.
CMS proposes at proposed § 428.401
the use of an initial Preliminary Rebate
Report and a subsequent Rebate Report,
with an opportunity for manufacturers
to identify certain mathematical errors
(see proposed § 428.403 and discussed
in further detail later in this section)
and two regular reconciliations of the
rebate amount to account for updates to
claims and payment data at 12 months
and 36 months after the Rebate Report
is issued as described in proposed
§ 428.401(d).
CMS proposes in proposed § 428.401
that the multi-step reporting process for
providing rebate information to a
manufacturer would include: (1) an
initial report, which CMS proposes to
entitle the ‘‘Preliminary Rebate Report’’
in proposed § 428.401(b) and (2) a
second report, which CMS proposes to
entitle the ‘‘Rebate Report’’ in proposed
§ 428.401(c). The Rebate Report would
serve as the invoice for the rebate
amount due, if any, for each product
determined to be a Part D rebatable drug
for the applicable period, as specified in
proposed § 428.101. Manufacturers of
Part D rebatable drugs would receive a
Rebate Report for their rebatable drugs
even if the amount due is $0. CMS
proposes at proposed § 428.401(d)(1)
two regular reconciliations of the rebate
amount to occur 12 months and 36
months after issuance of the subsequent
Rebate Report specified in proposed
§ 428.401(c), which would include any
restatements that have occurred in the
drug pricing data and claims billing data
reported to CMS and used in the rebate
calculation specified in subpart C of this
part.
As the first step in the reporting
process, as proposed in proposed
§ 428.401(b) and consistent with section
50 of the revised Medicare Part D Drug
Inflation Rebate Guidance, CMS would
provide each manufacturer of a Part D
rebatable drug with the preliminary
rebate amount through a Preliminary
Rebate Report at least 1 month prior to
the issuance of the Rebate Report
specified in proposed § 428.401(c) for an
applicable period (that is,
approximately 8 months after the end of
the applicable period unless otherwise
specified). To facilitate manufacturer
understanding of the Preliminary Rebate
Report, CMS is proposing in proposed
§ 428.401(b)(1) that the Preliminary
Rebate Report would include the
following information: the NDC(s) for
the Part D rebatable drug as defined
under proposed § 428.20; the total
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number of units for the Part D rebatable
drug for the applicable period as
determined under proposed § 428.203
(which would remove units when a
generic drug is no longer a Part D
rebatable drug in proposed
§ 428.203(b)(1) and would exclude units
acquired through the 340B Program in
proposed § 428.203(b)(2)); the
benchmark period manufacturer price as
described in proposed § 428.202(d); the
AnMP for the Part D rebatable drug for
the applicable period as determined in
proposed § 428.202(b); the applicable
benchmark period and applicable
period CPI-Us as identified in proposed
§§ 428.202(e) and 428.20; the inflationadjusted payment amount as specified
in proposed § 428.202(f); the amount, if
any, of the excess AnMP for the Part D
rebatable drug for the applicable period
as determined under proposed
§ 428.202(a); any applied reductions as
described in proposed §§ 428.301,
428.302, and 428.303; and the rebate
amount due as specified in proposed
§ 428.201(a). As proposed under
proposed § 428.204, in cases where a
Part D rebatable drug is a line extension,
CMS proposes to include the same
elements described above in the
Preliminary Rebate Report as well as:
the NDC for the initial drug; the
inflation rebate amount ratio for the
initial drug; and the alternative rebate
amount (see proposed § 428.401(b)(2)).
When determining what information
should be included on rebate reports,
CMS considered the statutory
requirements outlined in section
1860D–14B(a)(1) of the Act to determine
which data elements are necessary to
review the Preliminary Rebate Report
for error (described later in this section)
and to protect proprietary information.
In response to comments on the initial
Medicare Part D Drug Inflation Rebate
Guidance, CMS has proposed to
disclose data elements as suggested by
interested parties that are not
enumerated in the statute, such as NDCs
for Part D rebatable drugs and the
applicable period CPI–U. CMS
acknowledges requests from interested
parties to provide additional data
elements including claims-level data
such as days’ supply, fill number, and
prescription ID number on rebate
reports that are not included in this
proposal. CMS considered these
requests in development of this
proposed rule but does not believe it
necessary to provide this further
information to fulfill its statutory
obligation and believes that the
potential benefit to manufacturers of
additional data are outweighed by the
administrative burdens additional
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reporting would impose to the agency.
The elements listed above provide
sufficient information for a
manufacturer to review the Preliminary
Rebate Report for mathematical error,
while protecting proprietary
information, and these elements are
operationally feasible for CMS to
provide. In proposed
§ 428.203(b)(2)(i)(A) and (B), CMS
would exclude 340B units beginning
with January 1, 2026, which is the
second calendar quarter in the
applicable period starting October 1,
2025, and beyond (as discussed in
further detail in section III.I.3.f of this
proposed rule). This exclusion applies
to all Preliminary Rebate Reports,
Rebate Reports, and reconciliations of a
rebate amount that include the
applicable period starting with October
1, 2025, and beyond with claims for
service dates on or after January 1, 2026.
As such, 340B units would not be
excluded from the Rebate Reports for
the applicable periods beginning
October 1, 2022, October 1, 2023, and
October 1, 2024, as discussed in
proposed § 428.402.
By structuring the Rebate Report
process to include a Preliminary Rebate
Report before the Rebate Report, CMS is
able to provide manufacturers with an
opportunity to review the Preliminary
Rebate Report before the rebate amount
is invoiced via the Rebate Report. While
CMS is not required to provide a
preliminary report, CMS seeks to
facilitate manufacturer understanding of
the Rebate Report and believes it would
be beneficial for manufacturers to
review the report for mathematical
errors that could be corrected before
invoicing via the Rebate Report. Further,
a Preliminary Rebate Report would
provide additional notice to
manufacturers regarding whether they
may owe a rebate amount.
In proposed § 428.403, CMS proposes
a process in which a manufacturer may
suggest to CMS that the manufacturer
believes the Preliminary Rebate Report
includes a mathematical error within 10
calendar days after the date of receipt of
the Preliminary Rebate Report. For
example, if the Preliminary Rebate
Report is provided on May 31, 2026,
then June 1, 2026, would be the date of
receipt and, therefore, day one of the 10calendar-day period to submit a
Suggestion of Error; the Suggestion of
Error would be due at 11:59 p.m. PT on
June 10, 2026, in this example. CMS
reviewed comments on the 10-day
Suggestion of Error period submitted in
response to the initial Medicare Part D
Drug Inflation Rebate Guidance, many
of which suggested that manufacturers
receive at least 30 days to review the
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Preliminary Rebate Report. CMS
considered a 10-day, 15-day, and 30-day
Suggestion of Error period and believes
a 10-calendar-day period as (see
proposed § 428.403(c)) is sufficient after
considering the volume of the data to be
provided to manufacturers, the narrow
scope of items that may be identified as
a Suggestion of Error, and the
operational time necessary for CMS to
provide a Rebate Report within 9
months of the end of the applicable
period as required under section
1860D–14B(a)(1) of the Act. However,
CMS proposes in § 428.402(c)(1)(i) to
expand the Suggestion of Error period to
30 calendar days for the Preliminary
Rebate Reports for the first two
applicable periods (beginning October 1,
2022, and October 1, 2023). This
extended Suggestion of Error period will
provide additional time and flexibility
during the first invoicing cycle of the
Medicare Part D Drug Inflation Rebate
Program.
Section 1860D–14B(f) of the Act
precludes administrative or judicial
review on the determination of units,
whether a drug is a Part D rebatable
drug, and the calculation of the rebate
amount (see proposed § 428.403(a)(1)).
Therefore, the Suggestion of Error
process will be limited to mathematical
steps involved in determining the rebate
amount and the elements precluded
from administrative or judicial review
will not be considered in-scope for the
Suggestion of Error process.
Additionally, CMS is not providing an
administrative dispute resolution
process. CMS intends to consider all inscope submissions under the Suggestion
of Error process (for example,
suggestions regarding a mathematical
error) as described in proposed
§ 428.403(a). CMS does not intend to
review suggestions of error that are outof-scope or submissions for a rebatable
drug with an amount due of $0.
As the second step in the reporting
process, CMS proposes in proposed
§ 428.401(c) to provide the rebate
amount to the manufacturer through the
Rebate Report no later than 9 months
after the end of the applicable period.
As proposed in proposed§ 428.401(c)(1),
the Rebate Report would include the
same data elements as the Preliminary
Rebate Report (specified in proposed
§ 428.401(b)(1)) and include any
recalculations based on CMS acceptance
of a manufacturer’s Suggestion of Error
from proposed § 428.403, or any CMSdetermined recalculations from
proposed § 428.401(d)(2), if applicable.
Manufacturers must pay the rebate
amount within 30 calendar days from
the date of receipt of the Rebate Report
(see proposed § 428.405(a)). For
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example, if the Rebate Report is
provided on June 30, 2026, then July 1,
2026, would be the date of receipt and
therefore day one of the 30-calendar-day
payment period; payment would be due
no later than 11:59 p.m. PT on July 30,
2026.
In proposed §§ 428.404 and 428.405,
CMS proposes that it will establish a
standard method and process to issue
Rebate Reports and accept manufacturer
rebate payments. This method and
process may include an online portal
administered by a CMS contractor
which would provide manufacturers
with access to their Rebate Report, the
ability to submit a Suggestions of Error,
and pay a rebate amount due. CMS
intends to provide technical
instructions separate from this
rulemaking to manufacturers of Part D
rebatable drugs regarding how to access
Rebate Reports and how to receive
notifications alerting the manufacturer
when information is available. CMS also
intends to issue reminder notices to
manufacturers regarding the due date of
rebate payments. In proposed
§ 428.404(a), CMS notes that the
manufacturer that may access Rebate
Reports and make applicable rebate
amount payments is the manufacturer
responsible for paying a rebate, and as
stated above, CMS proposes to identify
the manufacturer that is responsible for
paying a rebate using the same approach
used for reporting AMP data.
iii. Reconciliation of a Rebate Amount
As discussed in section 50 of the
revised Medicare Part D Drug Inflation
Rebate Guidance, CMS considered
options consistent with section 1860D–
14B(b)(6) of the Act to establish a
method and process to determine
adjustment to the rebate amount in the
case of a Part D plan sponsor submitting
revisions to the number of units of a
part D rebatable drug. As is also
discussed in section 50, CMS
considered options for establishing a
standardized method and process at
regular intervals to determinate any
appropriate adjustments to the rebate
amount for a Part D rebatable drug for
an applicable period to account for
additional revised information as well
as options for recalculation based on
CMS identifying an agency error or
determining manufacturer data was
misreported. CMS is proposing policies
for reconciliation, including with
respect to enforcement of payment of
any reconciled rebate amount,
consistent with both the statutory
framework for the Part D Drug Inflation
Rebate Program and the express
authority in sections 1102 and 1871 of
the Act to adopt regulations for the
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proper administration of the Medicare
Prescription Drug Inflation Rebate
Program.
As proposed at § 428.401(d), CMS
believes that it is necessary and
appropriate for CMS to recalculate the
rebate amount for an applicable period
at regular intervals to include updated
information about key data elements
included in the calculation of the rebate
amount, not limited to those data
described in section 1860D–14B(b)(6) of
the Act. These data elements as set forth
in proposed § 428.401(d)(1)(i) include:
total units; the benchmark period
manufacturer price; the payment
amount in the payment amount
benchmark period; the AnMP; and
updated data on line extension
calculations. Updating these calculation
inputs at regular reconciliation intervals
will result in a rebate amount that more
fully reflects the majority of shifts in the
underlying data following additional
time for claims run-out, which refers to
the maturation of PDE records in CMS’
internal PDE database. Because the
information extracted represents the
PDE records’ status in CMS’ internal
PDE database at that moment in time,
additional run-out may yield different
information, either because more PDE
records with dispensing dates during
the applicable period were finalized and
added to the database or because the
status of the existing PDE records
changed. CMS refers to ‘‘X months of
run-out’’ as the period between the end
of the applicable period and the date
when CMS accesses information about
the PDE records; for example, ‘‘3
months of run-out’’ means that PDE
records are accessed for PDE records
with dispensing dates during an
applicable period 3 months after the end
of such applicable period. Conducting a
reconciliation of the rebate amount with
additional claims run-out will improve
the accuracy of the rebate amount.
Additionally, reconciliation of payment
amounts is consistent with the approach
to the calculation of the payment
amounts in other CMS programs (such
as the Coverage Gap Discount Program)
that provide for a reconciliation period.
CMS notes that the reconciliation of a
rebate amount, whether during a
reconciliation proposed at
§ 428.401(d)(1) or a discretionary
reconciliation proposed at
§ 428.401(d)(2) discussed further below,
will not create a separately payable and
distinct rebate amount. Rather,
reconciliation updates the prior rebate
amount owed to CMS, if any, by a
manufacturer of a Part D rebatable drug
so that the rebate amount ultimately
reflects a more precise calculation of the
rebate amount, as required by section
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1860D–14B(a)(1) of the Act, to account
for shifts in the underlying data
following additional time for claims
run-out after the Rebate Report is issued
as well as subsequently identified data
integrity issues. Moreover, because the
reconciled rebate amount is an
adjustment of the prior rebate amount,
CMS proposes at § 428.405(a)(1) for a
report of a reconciled rebate amount to
also identify the difference between the
rebate amount due as specified on the
Rebate Report set forth in proposed
§ 428.401(c) and the reconciled rebate
amount. CMS would only collect the net
rebate amount due, if any, upon
reconciliation, so as to prevent any
duplicate payments. CMS also proposes
to refund any overpayment made by a
manufacturer, as determined during
reconciliation, as discussed in proposed
§ 428.405(b).
Additionally, as CMS suggested in
section 50 of the revised Medicare Part
D Drug Inflation Rebate Guidance, CMS
considered multiple options for
establishing a standardized method and
process to occur at regular intervals to
determine an appropriate adjustment to
the rebate amount for a Part D rebatable
drug for an applicable period to account
for revised information prior to adopting
the proposal described here with two
proposed regular reconciliations of the
Part D inflation rebate amount. CMS
considerations included the length of
time needed to capture relevant changes
to data inputs for recalculation, whether
the timing should align with the
reconciliation of Part B rebate amounts,
and manufacturer burden. Specifically,
CMS considered the average time span
needed to ensure submission of the
majority of Part D plan unit revisions
specified in section 1860D–14B(b)(6) of
the Act, and the average time span
needed for the submission of the
majority of manufacturer restatements of
AMP data. CMS also considered the 36month period provided by MDRP for
AMP restatements as described in
§ 447.510(d)(3) of this title and whether
consistency among program
reconciliation timelines is beneficial.
CMS believes a longer period of claims
run-out (at least 12 and 36 months of
run-out time in the proposed approach)
would ensure that CMS more fully
accounts for capturing of revised units.
Further, the first reconciliation would
be performed to include at least 13
months of claims run-out for the
applicable period and would be issued
12 months after the Rebate Report for
the same applicable period. The second
reconciliation would include 37 months
of claims run-out for the applicable
period and would be issued 36 months
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after the Rebate Report for the same
applicable period. The first
reconciliation, issued 12 months after
the Rebate Report, would provide
sufficient time to capture the majority of
updates to the data specified in
proposed § 428.401(b)(1). The second
reconciliation, to be issued 36 months
after the Rebate Report, is sufficient to
capture the remainder of the run-out for
MDRP AMP restatements (that do not
require CMS review in § 447.510) while
also closing out the calculation of the
rebate amount for a Part D rebatable
drug for an applicable period within a
reasonable time period after the Rebate
Report is issued (except for the
circumstances in proposed
§ 428.401(d)(2) regarding CMS’
identification of mathematical errors or
manufacturer misreporting).
Further, in considering whether
consistency across CMS programs is
critical, CMS believes that consideration
for the completeness of data, as
discussed above, should be prioritized
over consistency across program
timelines. That is, when examining
timelines from other CMS programs that
collect data contributing to calculation
of the rebate amount, CMS prioritized
that, to the extent feasible, completeness
and accuracy of the data elements
contributing to the calculation of the
rebate amount rather than prioritizing
consistency among the data collection
and reconciliation timelines themselves.
Finally, CMS believes that solely
updating total units without updating
other elements of the rebate calculation
would lead to an inaccurate rebate
amount, and therefore proposes to
update additional calculation inputs as
described in proposed
§ 428.401(d)(1)(i)(A) through (F). CMS
believes that a restatement of each data
element included in proposed
§ 428.401(d)(1) to reconcile the rebate
amount provided in the Rebate Report
in proposed § 428.401(c) is appropriate
to capture an updated rebate amount
and is in line with other CMS programs
that provide for a reconciliation period.
While some data points may not change,
CMS would review the data to
determine if there are any updates in the
data and use the updated data in the
reconciliation to provide a reconciled
rebate amount to the manufacturer.
Based on these considerations, similar
to the multi-step process for the Rebate
Report proposed in § 428.401(b) and (c),
CMS proposes a multi-step process to
provide each manufacturer of a Part D
rebatable drug with a reconciled rebate
amount on a regular basis. At both the
12 month reconciliation point and the
36 month reconciliation point, CMS
proposes a reconciliation process that
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will include: (1) a preliminary
reconciliation of the rebate amount,
which CMS would provide to
manufacturers of Part D rebatable drugs
as proposed in § 428.401(d)(1)(i) and
(d)(2) a reconciled rebate amount, which
CMS would provide to manufacturers of
a Part D rebatable drug as proposed in
§ 428.401(d)(1)(ii). CMS also proposes to
apply the Suggestion of Error process
specified in proposed § 428.403 to each
preliminary reconciliation.
In detail, first, as specified in
proposed § 428.401(d) and similar to the
Preliminary Rebate Report process
proposed in § 428.401(b), for each
reconciliation CMS proposes to provide
the manufacturer with information
about the preliminary reconciliation of
the rebate amount at least 1 month prior
to the issuance of the reconciled rebate
amount (see proposed § 428.401(d)) to
each manufacturer of a Part D rebatable
drug for an applicable period. CMS
proposes in § 428.401(d)(1) that the
preliminary reconciliation would
include, at a minimum, the same
information outlined for the Rebate
Report and the following updated
information, if applicable: updated total
number of rebatable units, including
updates submitted by a PDP or MA–PD
plan sponsor and updates to 340B units
(as applicable to the dates of service and
applicable periods specified in
proposed § 428.203(b)(2)(i)(A) and (B)),
or units otherwise excluded as specified
in proposed § 428.203(b); the
benchmark period manufacturer price if
any inputs are restated within the
reconciliation run-out period as
specified in proposed § 428.202(d); the
AnMP if any inputs are restated within
the reconciliation run-out period as
specified in proposed § 428.202(b); the
excess amount by which the AnMP
exceeds the inflation-adjusted payment
amount for the applicable period as
specified in proposed § 428.202(a),
using the most recent AMP (if any
inputs are restated within the
reconciliation run-out period); updated
data on line extension calculations,
including the initial drug identified in
accordance with § 447.509(a)(4)(iii)(B),
the inflation rebate amount ratio, and
the alternative total rebate amount as set
forth in proposed § 428.204 if any
inputs are restated within the
reconciliation run-out period; the
reconciled rebate amount as set forth in
proposed § 428.201(a); and the
difference between the total rebate
amount due as specified on the Rebate
Report set forth in proposed § 428.201(a)
and the reconciled rebate amount as set
forth in proposed § 428.201(a). CMS also
notes that changes to status of 5i drugs
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(defined at § 447.507) are captured
through AMP restatements.
In proposed § 428.403(a), similar to
the Suggestion of Error process
proposed for the Preliminary Rebate
Report in proposed § 428.401(b), within
10 calendar days after date of receipt of
the information about the preliminary
reconciliation of the rebate amount,
CMS proposes that a manufacturer may
suggest to CMS that the manufacturer
believes the preliminary reconciliation
of the rebate amount contains a
mathematical error. CMS believes a 10calendar-day period is sufficient due to
the same considerations of data volume,
the narrow set of in-scope items for
review, and the operational time
necessary for CMS to publish the
reconciled rebate amount. The
preclusions in section 1860D–14B(f) of
the Act on administrative and judicial
review apply to the reconciliation
process.
Second, in detail, CMS proposes in
§ 428.401(d)(1)(ii) to provide a
reconciled rebate amount to the
manufacturer within 12 months and 36
months after the Rebate Report was
issued for each applicable period. As
proposed in § 428.401(d)(1)(ii), the
information in the report for a
reconciled rebate amount would include
the same data elements as provided in
the information provided to the
manufacturer of a Part D rebatable drug
regarding the preliminary reconciliation
of a rebate amount (specified in
proposed § 428.401(d)(1)(i)) and would
include any recalculations based on
CMS acceptance of a manufacturer’s
Suggestion of Error from proposed
§ 428.403. A reconciliation of the rebate
amount may result in an increase,
decrease, or no change to the rebate
amount, compared to the Rebate Report
for an applicable period or a previous
reconciliation in the case of
reconciliation conducted 36 months
after issuance of the Rebate Report (see
proposed § 428.401(d)(3)).
Additionally, as suggested in section
50 the revised Medicare Part D Drug
Inflation Rebate Guidance, CMS
considered options for establishing
circumstances where a recalculation of
the rebate amount may be appropriate
for an applicable period after issuing the
Rebate Report and/or a reconciled rebate
amount based on CMS identifying an
error or CMS determining that the
information used by CMS to calculate a
rebate amount was inaccurate due to
false reporting or similar fault by the
manufacturer. CMS also considered
potential time limits for revisions and
whether certain circumstances, such as
instances of false reporting, should be
exempt from such time limits.
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Based on these considerations, CMS
believes that, to capture an accurate
rebate amount and consistent with
reconciliations of pricing data submitted
to CMS that provide for revisions when
necessary due to errors, including
mathematical errors, and manufacturer
misreporting, certain circumstances
merit reconciliation of the rebate
amount separate from the 12-month and
36-month reconciliations proposed at
§ 428.401(d)(1). Specifically, CMS
proposes in § 428.401(d)(2) that CMS
may reconcile a rebate amount of an
issued Rebate Report when CMS
identifies either: (1) an agency error
such as a mathematical error or an error
in the information specified in a Rebate
Report as described in proposed
§ 428.401(c) or report of a reconciled
rebate amount as described in proposed
§ 428.401(d), including reporting system
or coding errors; or (2) CMS determines
that information used to calculate the
rebate amount was inaccurate due to
manufacturer misreporting. Examples of
agency errors could include CMS
incorrectly calculating the billing units
per Part D rebatable drug or the
mechanism that provides a Rebate
Report to the manufacturer or the Rebate
Report incorrectly displays a rebate
amount. Examples of manufacturer
misreporting could include instances in
which the manufacturer has made a
correction to previously submitted data
as well as instances in which the
reporting individual or entity reporting
data or information to CMS on behalf of
the manufacturer knows or should know
is inaccurate or misleading (for
example, inaccurate manufacturer
pricing or product data under section
1927(b)(3) of the Act). This does not
include standard restatements to AMP
or other data outside of the standard
process of issuing the reconciled rebate
amount. In addition to manufacturerinitiated corrections, CMS may become
aware of manufacturer misreporting
based on fact finding and conclusions of
enforcement authorities, for example,
the HHS Office of Inspector General, the
CMS Center for Program Integrity, or the
Department of Justice. In a situation
where an error or manufacturer
misreporting is identified prior to the
12- or 36-month reconciliation of the
rebate amount proposed in
§ 428.401(d)(1), CMS may choose to
include a correction based on the
circumstances proposed in
§ 428.401(d)(2) concurrently with the
12- or 36-month reconciliation. When
CMS reconciles data due to an instance
of agency error or manufacturer
misreporting, CMS proposes that the
agency would limit the scope of the
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reconciliation to the specific
information that is the basis for the
reconciliation and not update or
otherwise revise any other data
elements in the Rebate Report (specified
in proposed § 428.401(c)) or the report
of the reconciled rebate amount
(specified in proposed § 428.401(d))
unless the correction directly impacts
additional data fields. For example,
corrections to an AMP file may not
change the AnMP for the applicable
period.
In addition, because reconciling a
rebate amount imposes substantial
administrative burden on CMS to
reprocess the rebate amount, retest the
reporting system, and reissue a Rebate
Report, CMS proposes in § 428.401(d)(2)
that it may exercise discretion not to
initiate recalculation of the rebate
amount in these situations which are
outside of the regular reconciliation
process proposed in § 428.401(d)(1).
CMS proposes that for a recalculation
due to an agency error, the error must
be identified within 5 years of the date
of receipt of the Rebate Report for the
applicable period (see proposed
§ 428.401(d)(2)(i)). Identification means
that CMS has knowledge of the error;
CMS does not need to have completed
its revision of the impacted data or
determined if the revision impacts the
rebate amount within the 5-year period.
CMS would timely complete these steps
and determine, when reconciliation
does impact the rebate amount, whether
the reconciliation must be included in
a discretionary revision or within an
upcoming reconciled rebate amount for
the applicable period. CMS proposes 5
years for Part D (as opposed to the 3year limit proposed for Part B) to
account for the additional time of the
second reconciliation for Part D
rebatable drugs to be conducted at 36months proposed in § 428.401(d)(1).
CMS believes that a 5-year period dating
from the issuance of the Rebate Report
allows for sufficient time to include
AMP restatements in the MDRP while
also placing a reasonable time limit on
potential discretionary reconciliations,
after which a manufacturer of a Part D
rebatable drug would not receive
additional Rebate Reports for the
applicable period.
CMS proposes in § 428.401(d)(2)(ii)
that for a circumstance in which a
manufacturer misreports data, CMS is
not bound by the 5-year time limit for
revision of the rebate amount. For
example, if a determination is made that
a manufacturer misreported AMP data,
which affected the calculation of the
AnMP, then CMS may recalculate the
rebate amount owed for a Part D
rebatable drug. CMS requests comments
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on the proposals related to manufacturer
misreporting.
CMS proposes in § 428.405(a)(1) that
upon receipt of a reconciled rebate
amount, manufacturers must pay that
reconciled rebate amount within 30
calendar days from the date of receipt of
the reconciled rebate amount. A 30-day
payment deadline aligns with the
payment period set forth in statute at
section 1860D–14B(b)(6) of the Act. As
specified in proposed § 428.404, CMS
would use the same method and process
for issuing Rebate Reports and
submission of payments for reports with
a reconciled rebate amount. CMS would
provide notice to manufacturers for
reports with a reconciled rebate amount.
CMS proposes in § 428.405(b) that if a
refund is owed to a manufacturer based
on a reconciled rebate amount, CMS
would initiate the process to issue such
refund within 60 days from the date of
receipt of the reconciled rebate amount
(proposed in § 428.401(d)). CMS will
issue additional information on this
method and process through additional
program communications.
iv. Rebate Reports for the Applicable
Periods Beginning October 1, 2022, and
October 1, 2023
Section 1860D–14B(a)(3) of the Act
provides the CMS with the option to
delay sending the information required
by section 1860D–14B(a)(1) for the
applicable periods beginning October 1,
2022, and October 1, 2023, until not
later than December 31, 2025. In
§ 428.402, consistent with section 50.2
of the revised Medicare Part D Drug
Inflation Rebate Guidance, CMS
proposes to issue a Preliminary Rebate
Report for each applicable period
followed by issuance of the Rebate
Report for each applicable period no
later than December 31, 2025. For these
reports, CMS proposes in § 428.402 to
provide an extended 30 calendar day
Suggestion of Error period for these
Preliminary Rebate Reports.
Because this approach provides for 13
months of claims run-out for the Rebate
Report for the applicable period
beginning October 1, 2022, CMS intends
to conduct a single reconciliation 21
months after issuance of the Rebate
Report for this applicable period (see
proposed § 428.402(c)(1)(ii)). As
specified in § 428.402(c)(2)(ii), for the
applicable period beginning October 1,
2023, the rebate amount would be
reconciled twice, in alignment with the
reconciliation process discussed
previously. The first reconciliation
would occur 9 months after issuance of
the Rebate Report to include 13 months
of claims run-out and payment data; the
second reconciliation would occur 24
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months after the first reconciliation and
would include 37 months of claims runout and payment data. This approach
aligns claims and payment data run-out
with the run-out used during a regular
invoicing cycle. The Suggestion of Error
period would be 10 calendar days for
the reconciliations of the rebate amount
for the applicable periods beginning
October 1, 2022, and the applicable
period beginning October 1, 2023.
This approach also minimizes the
number of reports issued to
manufacturers as a result of the delay in
reporting and simplifies payment
procedures, thereby minimizing
manufacturer burden. Starting with the
applicable period beginning October 1,
2024, reporting would begin a standard
cadence and follow the procedures
otherwise proposed in subpart E of this
part 428.
CMS proposes that manufacturers that
do not pay the Medicare Part D drug
inflation rebate amount owed for a Part
D rebatable drug within 30 calendar
days of receiving a Rebate Report,
including reports containing a
reconciled rebate amount, may be
subject to a civil money penalty of 125
percent of the rebate amount, as
applicable, for such drug for the
applicable periods. The civil money
penalty is in addition to the rebate
amount.
f. Enforcement of Manufacturer Payment
of Rebate Amounts (§ 428.500)
Section 1860D–14B(e) of the Act gives
CMS the authority to impose a civil
money penalty equal to 125 percent of
the rebate amount for each drug for each
applicable period on a manufacturer
that fails to pay the rebate amount, for
each dosage form and strength for each
rebatable drug. Subpart F would
implement this section of the Act and
establish the procedures for determining
and collecting a civil money penalty.
In accordance with sections 1860D–
14B(a)(2) and 1860D–14B(b) of the Act
and proposed § 428.405(a),
manufacturers must provide to CMS a
rebate amount owed within 30 calendar
days of receipt of the rebate amount
due. As described in proposed
§ 428.500(a), CMS is proposing it may
impose a civil money penalty when a
manufacturer fails to pay the rebate
amount in full by the payment
deadlines in proposed § 428.405(a). This
means a manufacturer may be subject to
a civil money penalty if the
manufacturer fails to pay the full rebate
amount as invoiced in the Rebate Report
or any reconciled rebate amount that is
greater than the amount invoiced in the
Rebate Report. More specifically, a
manufacturer could be subject to a civil
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money penalty when a manufacturer
fails to pay a rebate amount due by any
payment deadline proposed in
§ 428.405(a)(1), for: (1) a Rebate Report
specified in proposed § 428.401(c); (2) a
reconciled rebate amount greater than
the amount reflected in the Rebate
Report specified in proposed
§ 428.401(d); or (3) a Rebate Report and
a reconciled rebate amount greater than
the amount reflected in the Rebate
Report, if applicable, for the applicable
periods beginning October 1, 2022, and
October 1, 2023 specified in proposed
§ 428.402. As discussed earlier in
section III.I.3.e, CMS notes that the
reconciled or corrected rebate amount is
not a separately payable and distinct
rebate amount. Rather, the reconciled
rebate amount is an update to the rebate
amount owed to CMS by a manufacturer
of a Part D rebatable drug.
Civil money penalties are a point-intime penalty tied to the rebate amount
due at the applicable payment deadline,
which occurs 30 days after the date of
receipt of a Rebate Report. In proposed
§ 428.500(b), CMS proposes to establish
the methodology for determining the
amount of the civil money penalty as
equal to 125 percent of the rebate
amount for such drug for such
applicable period, and that this penalty
would be due in addition to the rebate
amount due. That is, a manufacturer
would be responsible for paying the full
rebate amount due in addition to any
civil money penalty imposed because of
late payment. CMS is proposing this
approach to civil money penalties based
on section 1860D–14B(a)(2) of the Act,
which establishes a requirement by the
manufacturer to provide CMS with a
rebate not later than 30 days after
receipt from CMS of the report on the
amount of the excess annual
manufacturer price increase. CMS
believes that the ability to assess civil
money penalties is necessary in all
circumstances where a payment is due
for a rebate amount to CMS to ensure
compliance with the rebate program’s
requirements. The civil money penalty
would be calculated based on the
outstanding rebate amount due at the
payment deadline, which is defined in
proposed § 428.405(a)(1) as 30 calendar
days after the date of receipt of a Rebate
Report containing any rebate amount
due; once a civil money penalty is
assessed due to a late payment, the
penalty would remain in effect even if
the manufacturer pays the outstanding
rebate amount as the penalty is initiated
due to a missed payment deadline.
Because the payment deadline is clearly
defined in section 1860D–14B(a)(2) of
the Act, any late payments of a rebate
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amount due, including late payment of
any reconciled rebate amounts greater
than the amount reflected in the Rebate
Report, would be considered a violation
potentially subject to a civil money
penalty. Any civil money penalty would
be assessed before the next 12- or 36month reconciliation.
CMS is proposing in § 428.500(b) that
civil money penalties may be calculated
at several points in time associated with
missing a payment deadline for the
rebate amount due reflected in the
Rebate Report or missing a payment
deadline associated with any rebate
amount determined after a
reconciliation to be greater than the
amount invoiced in the Rebate Report.
As these separate events can result in
distinct assessments of civil money
penalties, this means that CMS would
not modify a civil money penalty from
a prior missed payment deadline based
on changes to the rebate amount due
following reconciliation, including
scenarios where the rebate amount is
reduced following reconciliation.
However, in the event that the rebate
amount due on a Rebate Report was not
paid and a civil money penalty was
issued for violation of the payment
deadline, CMS would not issue a second
civil money penalty on a reconciled
rebate amount if reconciliation
decreased the rebate amount stated on
the Rebate Report. CMS believes that
enforcing this requirement after each
payment deadline, regardless of what
rebate amount a manufacturer may or
may not owe at a future payment
deadline, is necessary to maintain the
integrity of the program and consistency
of the implementation of the program.
Further, CMS is proposing this
approach to ensure an enforcement
approach that is operationally feasible
and applied consistently in all cases.
For examples of how this approach to
civil money penalties will work in
practice, see section III.I.2.g of this
preamble. CMS is proposing that civil
money penalties will function in the
same way for both the Part B and Part
D rebate programs. Given that the Part
D rebate program has two proposed
regular reconciliations, payment would
be due no later than 30 days after
issuance of a report of a reconciled
rebate amount for each reconciliation
under Part D.
Further, note that payment of any
civil money penalty does not obviate the
requirement for the manufacturer to pay
any outstanding rebate amount due,
including any rebate amount due
following a reconciliation. Therefore,
paying a civil money penalty does not
satisfy the obligation to pay the
underlying rebate amount on which the
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civil money penalty is calculated. In
addition, CMS is evaluating all available
options to ensure manufacturers’ timely
compliance with their rebate payment
obligations, including, without
limitation, potential recovery
approaches and enforcement actions.
For example, CMS may refer
manufacturers to the Department of
Justice, Department of the Treasury,
and/or the Department of Health and
Human Services Office of Inspector
General for further review and
investigation.
In proposed § 428.500(c), CMS
proposes that if CMS makes a
determination to impose a civil money
penalty on a manufacturer for violation
of a payment deadline, CMS would send
a written notice of the decision to
impose a civil money penalty that
includes a description of the basis for
the determination, the basis for the
penalty, the amount of the penalty, the
date the penalty is due, the
manufacturer’s right to a hearing, and
information about where to file the
request for a hearing. To ensure a
consistent approach to civil money
penalties, CMS proposes applying
existing appeal procedures for civil
money penalties in 42 CFR 423, subpart
T of this title to manufacturers
appealing a civil money penalty
imposed under the Medicare Part D
Drug Inflation Rebate Program. CMS has
utilized this appeals process for many
years for civil money penalty
determinations affecting MA
organizations and Part D sponsors. CMS
therefore proposes to use this wellestablished process for civil money
penalty appeals from manufacturers that
do not make inflation rebate payments
by the payment deadline. CMS also
proposes in § 428.500(e)(1) that the
scope of appeals is limited to: (1) CMS
determinations relating to whether the
rebate payment was made by the
payment deadline; and (2) the
calculation of the penalty amount.
Section 1860D–14B(f) of the Act
precludes judicial review of specific
data inputs or calculations related to the
underlying Rebate Report and
reconciliation; therefore, such data and
calculations are not appealable through
this process.
Section 1860D–14B(e) of the Act
states that the provisions of section
1128A of the Act (except subsections (a)
and (b)) apply to civil money penalties
under this subpart to the same extent
that they apply to a civil money penalty
or procedure under section 1128A(a) of
the Act. CMS proposes to codify this
requirement in proposed § 428.500(f). In
alignment with the procedure outlined
in section 1128A of the Act, CMS
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proposes in § 428.500(d) that collection
of the civil money penalty would follow
expiration of the timeframe for
requesting an appeal, which is 60
calendar days from the civil money
penalty determination in cases where
the manufacturer did not request an
appeal. In cases where a manufacturer
requests a hearing and the decision to
impose the civil money penalty is
upheld, CMS would initiate collection
of the civil money penalty once the
administrative decision is final. CMS is
seeking comment on proposals related
to the violations of payment deadlines
and issuance of a civil money penalty.
CMS proposes in § 428.500(g) that in
the event that a manufacturer declares
bankruptcy, as described in title 11 of
the United States Code, and as a result
of the bankruptcy, fails to pay either the
full rebate amount owed or the total
sum of civil monetary penalties
imposed, the government reserves the
right to file a proof of claim with the
bankruptcy court to recover the unpaid
rebate amount and/or civil monetary
penalties owed by the manufacturer.
g. Severability (§ 428.10)
Proposed § 428.10 provides that, were
any provision of part 428 to be held
invalid or unenforceable by its terms, or
as applied to any person or
circumstance, such provisions would be
severable from this part and the
invalidity or unenforceability would not
affect the remainder thereof or any other
part of this subchapter or the
application of such provision to other
persons not similarly situated or to
other, dissimilar circumstances. While
the provisions in part 428 are intended
to present a comprehensive approach to
implementing the Medicare Part D Drug
Inflation Rebate Program, we intend that
each of them is a distinct, severable
provision, as proposed, and would not
affect similar provisions in the Medicare
Part B Drug Inflation Rebate Program.
Through this rulemaking, the Part D
drug inflation rebate proposals are
intended to operate independently of
each other, even if each serves the same
general purpose or policy goal. For
example, CMS intends that the policies
CMS is proposing related to exclusion of
units acquired through the 340B
Program (proposed § 428.203(b)(2)) are
distinct and severable from the
proposals related to Determination of
Part D Rebatable Drugs (proposed
§§ 428.100 and 428.101). Even where
one provision makes reference to a
second provision, the preamble and the
regulatory text clarify the intent of the
agency that the two provisions would be
severable if one provision were to be
invalidated in whole or in part. For
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example, CMS would still be able to
calculate a Part D drug inflation rebate
even if the provision to identify the
payment amount benchmark period for
a Part D rebatable drug as the first
calendar year in which such drug has at
least 1 quarter of AMP in certain
instances of missing AMP is deemed
invalid (proposed § 428.202(c)(3) and
(4)). CMS welcomes comments on this
severability policy.
J. Request for Information: Building
Upon the MIPS Value Pathways (MVPs)
Framework To Improve Ambulatory
Specialty Care
This request for information seeks
input from the public regarding the
design of a future ambulatory specialty
model. Responses to this request for
information may be used to inform
potential future rulemaking and other
policy development.
1. Background
Medicare beneficiaries’ care is
becoming more fragmented as they are
increasingly seeing (1) more specialists
and (2) specialists more often, while the
number of visits with their primary care
clinician remains relatively
constant.598 599 A primary care team
must now coordinate with more
specialists than ever before 600 to
achieve continuity in beneficiary care.
Medicare beneficiaries with chronic
conditions, in particular, are at high risk
of excess emergency department visits
due to fragmented care.601
In 2021, the Innovation Center
announced a strategic refresh with a
vision for a health care system that
achieves equitable outcomes through
high-quality, affordable, person
centered-care. This includes a bold goal
of having 100 percent of Medicare feefor-service (FFS) beneficiaries and the
vast majority of Medicaid beneficiaries
in an accountable care relationship by
598 Barnett ML, Bitton A, Souza J, Landon BE.
Trends in Outpatient Care for Medicare
Beneficiaries and Implications for Primary Care,
2000 to 2019 [published correction appears in Ann
Intern Med. 2022 Oct;175(10): 1492]. Ann Intern
Med. 2021;174(12): 1658–1665. doi: 10.7326/M21–
1523.
599 Timmins L, Urato C, Kern LM, Ghosh A, Rich
E. Primary Care Redesign and Care Fragmentation
Among Medicare Beneficiaries. The American
Journal of Managed Care, March 2022, Volume 28,
Issue 3.
600 Center for Medicare and Medicaid Services.
The CMS Innovation Center’s Strategy to Support
Person-centered, Value-based Specialty Care.
November 7, 2022. https://www.cms.gov/blog/cmsinnovation-centers-strategy-support-personcentered-value-based-specialty-care.
601 Kern, LM, Seirup, JK. Fragmented Ambulatory
Care and Subsequent Healthcare Utilization Among
Medicare Beneficiaries. The American Journal of
Managed Care. 2018;24(9):e278–e284.
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2030.602 To expand accountable care
among specialists and to drive more
person-centered care thereby improving
the quality, clinical outcomes, and
affordability of healthcare for
beneficiaries, the Innovation Center has
created a comprehensive specialty
strategy to test models and innovations.
This strategy includes: (1) enhancing
transparency of specialist data and
performance measures; (2) maintaining
momentum established by episode
payment models by extending the
Bundled Payments for Care
Improvement Advanced (BPCI
Advanced) Model, launching a new
model focusing on beneficiaries with
cancer, and testing a new mandatory
acute episode payment model; (3)
creating financial incentives to improve
coordination and collaboration between
primary care and specialty care in both
advanced primary care models and in
condition-based models; and (4)
creating additional financial incentives
for specialists to affiliate with
population-based models and move to
value-based care.603 604
As part of this strategy, we are
considering a model design that would
increase the engagement of specialists in
value-based payment and encourage
specialty care provider engagement with
primary care providers and
beneficiaries. Specifically, we are
currently exploring developing a model
for specialists in ambulatory settings
that would leverage the Merit-based
Incentive Payment System (MIPS) Value
Pathways, or MVP, framework. As
currently envisioned, participants under
this model would not receive a MIPS
payment adjustment. Instead, a model
participant would receive a payment
adjustment based on (1) a set of
clinically relevant MVP measures that
they are required to report and (2)
comparing the participant’s final score
against a limited pool of clinicians
(other model participants of their same
specialty type and clinical profile, who
are also required to report on those same
clinically relevant MVP measures).
Currently, under MIPS, performance
and the subsequent payment adjustment
602 Centers for Medicare and Medicaid Services.
Driving Health System Transformation—A Strategy
for the CMS Innovation Center’s Second Decade.
October 2021. https://www.cms.gov/priorities/
innovation/strategic-direction-whitepaper.
603 Center for Medicare and Medicaid Services.
The CMS Innovation Center’s Strategy to Support
Person-centered, Value-based Specialty Care.
November 7, 2022. https://www.cms.gov/blog/cmsinnovation-centers-strategy-support-personcentered-value-based-specialty-care.
604 ‘‘The CMS Innovation Center’s Strategy to
Support Person-Centered, Value-Based Specialty
Care: 2024 Update.’’ Health Affairs Forefront, April
2, 2024. DOI: 10.1377/forefront.20240328.868596.
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are based on a range of measures
voluntarily reported by clinicians, who
receive a final score based on the
submitted measures. A clinician’s
performance is assessed against a pool
of all clinicians, regardless of specialty
type or the services they provide. We
expect that a more targeted approach
where clinicians are evaluated (1) on a
set of relevant performance measures
they are required to report, and (2)
among clinicians furnishing similar sets
of services, would produce scores and
subsequent payment adjustments that
are more reflective of clinician
performance. A more targeted approach
to measurement would also offer more
insight into how clinical decisions and
processes, such as care coordination,
affect patient outcomes. We believe this
insight is necessary to support and
incentivize accountable care, increasing
beneficiary access to coordinated
specialty care. Furthermore, equipped
with more specialty-relevant
performance information, we expect
clinicians would be more likely to
invest resources in pursuit of better
outcomes, reducing the incidence of
poor outcomes arising from care
fragmentation, ultimately resulting in
better care for patients.
MVPs are a reporting option under
MIPS, which is one of the two primary
ways a clinician may participate in the
CMS Quality Payment Program. The
Quality Payment Program, which
commenced on January 1, 2017, was
established pursuant to the Medicare
Access and CHIP Reauthorization Act of
2015 (Pub. L. 114–10, April 16, 2015).
The Quality Payment Program rewards
the delivery of high-quality patient care
through two avenues: Advanced
Alternative Payment Models (Advanced
APMs) and MIPS for eligible clinicians
or groups under the Physician Fee
Schedule (81 FR 77008). CMS assesses
performance on measures and activities
in four performance categories to
determine each MIPS eligible clinician’s
performance under MIPS: quality; cost;
clinical practice improvement activities;
and Promoting Interoperability (42 CFR
414.1330, 414.1350, 414.1355, and
414.1375).
In response to concerns made by
interested parties that MIPS
requirements are confusing,
burdensome, and that it is difficult to
choose measures from the several
hundred MIPS and QCDR quality
measures that are meaningful to their
practices and have a direct benefit to
patients, CMS developed the MVP
reporting option to create a simplified
MIPS clinician experience, improve
value, reduce burden, and better inform
patient choice in selecting clinicians (86
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FR 65376). MVPs provide MIPS eligible
clinicians with a more cohesive subset
of measures and activities related to a
specific specialty or condition (86 FR
65420 through 65427). MVPs are
developed in coordination with
interested parties through an established
process in which clinician and patient
perspectives are incorporated (85 FR
84850). The use of MVPs can create
more meaningful performance data,
reduce complexity of the MIPS program
for clinicians, and lower the burden on
participating clinicians. MIPS eligible
clinicians have been able to report on
MVPs beginning with the CY 2023 MIPS
performance period.
Like MIPS eligible clinicians
participating in traditional MIPS, those
who report MVPs receive an adjustment
to their Medicare Part B fee-for-service
payments 2 years after the
corresponding MIPS performance
period based on a total score calculated
from reported measures and activities
across the 4 MIPS performance
categories (see §§ 414.1365, 414.1405(e),
and 414.1305). MVPs are designed to
cover a range of medical conditions,
care settings, and clinician types,
including primary care providers and
specialists. For the 2024 performance
year, 16 MVPs are reportable, allowing
for a range of specialties to report a
streamlined set of measures most
applicable to services they provide (88
FR 79978 through 80047). For
information on the MVPs reportable for
the 2024 performance period we refer
readers to sections IV.A.4 and Appendix
3 of this proposed rule.
Currently, 5 MVPs have quality
measures including patient-reported
outcome measures and chronic
condition episode-based cost measures,
which could be the foundation for
assessing the value of care provided to
chronic care patients. We believe
coordination between primary and
specialty care is particularly critical to
the ongoing management of chronic
conditions with beneficiaries not only
for reasons of quality and cost, but also
in understanding beneficiary goals,
expectations, and experiences with care.
CMS conducts ongoing MVP
development through engagement with
interested parties with the long-term
goal of sunsetting traditional MIPS
reporting and making MVP reporting
mandatory for MIPS eligible clinicians
in the future (86 FR 65395 and 87 FR
70040). For more information on the
long-term goal of sunsetting traditional
MIPS reporting, see section IV.A.3.b. of
this proposed rule. For more
information on CY 2025 MVP reporting
option proposals under the MIPS
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program, see section IV.A.4 of this
proposed rule.
Using the MVP framework as the
foundation for a model has many
benefits. First, the MVP framework
advances value-based care by narrowing
the available measure set based upon
clinician specialty, medical condition,
or patient population, which allows for
meaningful comparisons to be made
across providers and relevant feedback
to be available to participants on their
performance, strengthening the
foundation for accountability in
specialty care. The MVPs provide a
framework for reporting a cohesive set
of measures and activities focused on
the clinician’s performance in rendering
care for their specialty or clinical
condition.
Second, the payment methodology for
the model built on MVPs could address
concerns interested parties have raised
about the MIPS program. For instance,
CMS has heard from interested parties
that the current range of Medicare Part
B payment adjustments resulting from
MIPS participation may be insufficient
to encourage meaningful specialty care
transformation that results in increased
integration between primary and
specialty care. The model could test
ways to enhance existing incentives,
allowing for more specific comparisons
to be made between clinicians of the
same type who are providing similar
services to patients.
Third, such a model could reach a
broad range of clinicians of various
specialty types that have limited
opportunity to participate in Advanced
APMs. There are 16 MVPs for the 2024
performance year spanning numerous
specialties, and CMS is proposing
additional MVPs for the 2025
performance year with the goal of
creating MVPs that would be relevant to
the practices of 80 percent of MIPS
eligible clinicians. Using an existing
framework that is agnostic to specialty
type, as opposed to creating multiple
unique models that are each narrowly
defined by a condition or specialty,
would allow the Innovation Center to
take a more inclusive and unified
approach to increasing specialist
engagement in value-based payment.
While CMS continues to develop
more MVPs for additional health
conditions and specialties, an
ambulatory specialty model leveraging
the MVP framework could focus on a
subset of published MVPs in the initial
years of implementation, with the goal
of increasing the number of MVPs, and
thus the range of health conditions or
specialty areas, included in the model
over time. Using specific MVPs as the
basis for a model would, in part, require
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that selected MVPs cover a sufficient
volume of clinicians, address chronic
conditions with high Medicare
expenditures, align with existing
Innovation Center models (for example,
the Making Care Primary model), and
present an opportunity to strengthen the
integration between specialty care and
primary care.
We are soliciting comments on several
parameters of a potential model,
including considering mandatory
participation of relevant specialty care
providers to overcome challenges such
as selection bias and participant
attrition, and to ensure the model is
reaching a representative group of
providers and beneficiaries to facilitate
scaling of the model test. If CMS were
to propose a mandatory specialty model,
it would be done via notice and
comment rulemaking. We expect this
ambulatory specialty model would be
implemented no earlier than 2026,
ensuring participants have sufficient
time to prepare for the model.
2. Solicitation of Public Comments
The Innovation Center is releasing
this request for information (RFI) to
gather feedback on testing a new model
design to improve clinical outcomes and
reduce or maintain Medicare spending.
We request feedback on the design of a
future ambulatory specialty model,
specifically on the following—
• Participant definition;
• MVP performance assessment;
• Payment methodology;
• Care delivery and incentives for
partnerships with accountable care
entities and integration with primary
care;
• Health information technology and
data sharing;
• Health equity; and
• Multi-payer alignment.
Whenever possible, respondents are
requested to draw their responses from
objective, empirical, and actionable
evidence and to cite this evidence
within their responses.
a. Participant Definition
A key component of this potential
model is to define the Medicare Part B
clinicians that could participate in the
model. Participants in an ambulatory
specialty model using the MVP
framework could be limited to MIPS
eligible clinicians (see § 414.1305) with
specific ambulatory-based specialties for
a specific clinical focus area(s). The
model design must also consider
whether and how clinicians
participating in other APMs and
Advanced APMs (see §§ 414.1305 and
414.1415) would participate in the
model.
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To select participants, an ambulatory
specialty model would need to
determine which clinicians are
specialists and sub-specialists practicing
in the specified clinical areas prioritized
in the model. This process may be
complex as a single specialty often
comprises several sub-specialties, all of
which have specific clinical areas of
expertise and practice. For example, the
specialty of cardiology has
subspecialties, including general
cardiology, interventional cardiology,
electrophysiology, among others; and
interventional cardiologists treat a wide
range of acute and chronic
cardiovascular conditions and may
receive advanced training in the
endovascular treatment of specific
conditions, including coronary artery
disease and peripheral artery disease.
The MVP framework could provide a
natural starting point to identifying
participants within a given specialty or
sub-specialty. Each MVP provides
measures and activities for a range of
specialties and sub-specialties in a
clinical area or health topic, allowing
for specialties and sub-specialists to
select an applicable MVP and report the
measures and activities most relevant to
them.
MVP currently policies do not require
specialists to report specific MVPs but
encourage individuals or groups that are
MIPS eligible clinicians to elect to be an
MVP Participant and report an MVP that
is clinically relevant to them. Beginning
with the CY 2026 performance period,
an MVP Participant is assessed on an
MVP in accordance with § 414.1365 as
an individual MIPS eligible clinician,605
a single specialty group,606 subgroup,607
or APM entity 608 (see § 414.1305, ‘‘MVP
605 A MIPS eligible clinician who is an individual
and elects to report 1 MVP relevant to the
clinician’s clinical practice area(s).
606 A single specialty group that is a MIPS eligible
clinician and reports 1 MVP. Single specialty group
means a group that consists of one specialty type
as determined by CMS using Medicare Part B
claims (see § 414.1305). A groups means a single
TIN with two or more clinicians (including at least
one MIPS eligible clinician), as identified by their
individual NPI, who have reassigned their billing
rights to the TIN (Id.).
607 Subgroups means a subset of a group which
contains at least one MIPS eligible clinicians and
is identified by a combination of the group TIN,
subgroup identifier, and each eligible clinician’s
NPIs (see § 414.1305). Each subgroup consists of 2
or more clinicians from a group that is a MIPS
eligible clinician. Multiple subgroups can form
from a single group, which may be either a single
specialty group or a multispecialty group. Each
subgroup reports 1 MVP. An individual eligible
clinician (as represented by a TIN–NPI
combination) may register for no more than one
subgroup within a group’s TIN. (see
§ 414.1318(a)(3)).
608 An APM entity is a participant in an APM or
other payer arrangement through a direct agreement
with CMS, other payer, or through Federal or State
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participant’’). CMS has encouraged
MIPS eligible clinicians that are
multispecialty groups to participate in
subgroup reporting to allow the group to
report measures more relevant to each of
the group’s constituent specialties.
Multispecialty groups that choose to
report an MVP will be required to form
subgroups for that purpose beginning in
the CY 2026 performance period
(§ 414.1305, ‘‘MVP participant’’).
Within an ambulatory specialty
model, identification of a given
specialty or sub-specialty—including
whether an individual would be
selected to participate in the model at
an individual, group, or subgroup level
based on TIN and NPI combinations—
would need to rely on data sources to
which CMS already has access. Further,
approaches to participant identification
would need to appropriately identify
non-physician clinician types (for
example, physician assistants or nurse
practitioners) that may practice within a
specific specialty or sub-specialty or
both but may not be categorized as
practicing within a specific specialty
within existing data systems.
As multispecialty groups reporting
MVPs in the 2026 MIPS performance
period must divide into subgroups, CMS
finalized a process by which it will
determine whether a MIPS eligible
clinician that is a group practice is a
single specialty group or multispecialty
group. CMS finalized that it will use
Medicare Part B claims data to
determine a group’s specialty type based
on the strong alignment between the
Medicare Provider Enrollment, Chain,
and Ownership System (PECOS) and
Medicare Part B claims data sources,
and historical use of claims data to
identify a clinician or practice’s
specialty (87 FR 70038 through 70040).
Given the different circumstances and
challenges faced by clinicians working
in specific contexts, an ambulatory
specialty model could consider
additional characteristics of clinicians
or practices in addition to the
identification of participants based on
specialty or sub-specialty.609 Additional
law or regulation. An APM Entity can report and
be scored on multiple MVPs that are of clinical
interest or relevance (see § 414.1305).
609 For example, special status designations for
MIPS eligible clinicians confer additional
flexibilities in performance category reporting
requirements and category reweighting within final
score calculations. For the 2024 performance
period, several provider designations can receive
additional flexibilities in MVP reporting.
Ambulatory Surgical Center (ASC)-based, hospitalbased, non-patient facing, and small practice-based
(15 or fewer clinicians) providers are eligible for
automatic reweighting of the Promoting
Interoperability performance category to 0 percent,
with the category weight redistributed to other
performance categories. Small practice-based
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characteristics that could be considered
in participant selection in a model
could be related to factors documented
to be associated with disparities in
access to specialty care and disparities
in specialty-sensitive outcomes. Such
factors could include being a solo
clinician, practicing within a rural area,
serving a higher proportion of Medicare
and Medicaid dually eligible
beneficiaries and patients receiving
Medicare Part D low-income subsidies,
operating within a designated Health
Provider Shortage Area, among others.
For further discussion on additional
health equity considerations for the
model, see section III.J.2.f. of this
proposed rule, Health Equity.
Participant identification approaches
would also need to consider the
heterogeneity of existing specialty group
practices as the variation in clinical
practice across different specialties has
historically presented challenges for
specialists to engage more deeply in
value-based care.
Assuming an ambulatory specialty
model would initially focus on a subset
of specialists and eventually incorporate
additional specialties over time, CMS
would need to identify specialists for
the prioritized clinical areas before the
model begins. CMS seeks feedback on
the following questions:
(1) How should CMS identify single
specialty and multispecialty groups
while accounting for regular clinician
turnover? Which data sources and
methodology should CMS use to
consider identifying specialists and subspecialties that could potentially
participate in an ambulatory specialty
model?
(2) Should CMS consider different
identification approaches to identify
individual clinician specialist type
versus practice- or group-level specialty
types? If so, how?
(3) Are there certain characteristics of
clinicians or practices or both that may
warrant additional policy flexibilities or
exemption from participation in a
mandatory ambulatory specialty model?
What flexibilities should CMS consider
for these participants?
(4) How should CMS collect unbiased
comparison group data on quality and
costs for evaluation purposes? Would
mandating a control group to report
MVPs be appropriate for model
evaluation?
(5) How can CMS support a
multispecialty group’s ability to
successfully participate in MIPS and the
model if a portion of its clinicians are
reporting separate measures pursuant to
the model? What steps could CMS take
to reduce any added administrative
burden that might arise from such
separate reporting?
participants are also eligible for additional scoring
flexibilities in the quality performance category (see
§ 414.1380). MVP policies for the CY 2024
performance period state that special status
determination is determined at the group level for
subgroup participants (see § 414.1365).
610 Pursuant to section 1848(q)(2)(D) of the Act,
CMS selects measures for inclusion in the MIPS
program through notice and comment rulemaking.
To date, CMS has also elected to subject each MIPS
measure to the pre-rulemaking process pursuant to
section 1848(q)(2)(D)(ix) of the Act.
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b. MVP Performance Assessment
CMS adjusts future Medicare Part B
payments to MIPS eligible clinicians
based on the assessment of measures
and activities 610 reported across the 4
MIPS performance categories: Quality
(including Population Health), Cost,
Improvement Activities, and Promoting
Interoperability (see §§ 414.1380 and
414.1405). MVP Participants are
assessed in the same manner (see
§ 414.1365(d)). Scoring policies and
procedures are standardized across
MVPs (see § 414.1365(d)(3)). Resulting
performance category scores are
weighted as defined in regulations (see
§§ 414.1365(e)(1) and 414.1380(c)) and
are aggregated to compute an overall
final MVP score, which ranges from 0 to
100 points.
Quality—Each MVP defines a set of
reportable quality measures relevant to
the specialty or medical condition that
provide meaningful and actionable
results. Quality measure sets are
designed to cover a range of process and
outcomes measures that are applicable
to a range of clinicians working within
a given specialty or medical condition.
As of the CY 2024 performance period,
MVP Participants must report at least 4
quality measures, including at least 1
outcome measure or 1 measure
designated ‘‘high priority’’ if an
outcome measure is not available within
an MVP (see §§ 414.1365(c)(1) and
414.1305). Individual quality measures
must also meet case minimums to be
scored (see § 414.1380(b)(1)). Please
refer to section IV.A.4.c.(1). of this
proposed rule for proposed quality
measure reporting and scoring policies
for the CY 2025 performance period.
MVP participants are also scored on
population health administrative
claims-based measures, which are
factored into the MVP participant’s
overall quality performance category
score (see § 414.1365(c)(4)(ii)) (please
refer to sections IV.A.4.c.(1).(a). and
IV.A.4.c.(1).(b). of this proposed rule for
proposed population health measure
reporting and scoring policies for the CY
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2025 performance period).611 The
population health measures help
indicate the quality of a population or
cohort’s overall health and well-being,
such as, access to care, clinical
outcomes, coordination of care and
community services, health behaviors,
preventive care and screening, health
equity, or utilization of health services
(see § 414.1305).
Cost—Each MVP identifies cost
measures that are relevant and
applicable to the MVP topic or medical
condition. Given the availability of
applicable cost measures, the number of
reportable cost measures varies across
MVPs. An MVP may include the
episode-based cost measures (EBCM)
that are relevant to MVP topic, total per
capita cost (TPCC) measure, and
Medicare Spending Per Beneficiary
Clinician (MSPB Clinician) measure.
Cost measures are calculated by CMS
using administrative claims data, and
CMS scores MVP participants on all cost
measures included in the MVP that they
select and report (see
§ 414.1365(d)(3)(ii)). Please refer to
section IV.A.4.c.(2). of this proposed
rule for proposed cost measure reporting
and scoring policies for the CY 2025
performance period/2027 MIPS
payment year.
Improvement Activities—
Improvement activities (IAs) are
activities that relevant MIPS eligible
clinician, organizations and other
relevant interested parties identify as
improving clinical practice or care
delivery and that are likely to result in
improved outcomes. (see § 414.1305).
Improvement activities may cover
multiple improvement domains,
including expanded patient access,
population management, care
coordination, beneficiary engagement,
patient safety and practice assessment,
health equity, emergency response and
preparedness, and behavioral and
mental health (see § 414.1355(c)). MVP
participants must report IAs included in
a given MVP while meeting overall IA
reporting requirements for the
performance period. Please refer to
section IV.A.4.c.(3). of this proposed
rule for proposed IA reporting and
scoring policies for the CY 2025
performance period.
611 For the CY 2024 performance period, the two
population health measures from which
participants could select to be scored are: HospitalWide, 30-day, All-Cause Unplanned Readmission
Rate for the MIPS Groups and Clinician, or
Clinician Group Risk-standardized Hospital
Admission Rate for Patients with Multiple Chronic
Conditions. If the participant does not meet the case
minimum for either measure, then the population
health measure is excluded from scoring within the
quality performance category.
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Promoting Interoperability—The
Promoting Interoperability requirements
of MVPs are intended to emphasize the
electronic exchange of information
using certified electronic health record
technology (CEHRT), patient access to
health information, exchange of
information among clinicians, and the
systematic collection, analysis, and
interpretation of health care data. As of
the CY 2024 performance period/2026
MIPS payment year, MVP participants
are required to report the entire MIPS
Promoting Interoperability measure set,
which includes measures related to use
of CEHRT for e-prescribing, health
information exchange, public health and
clinical data exchange, and clinician-topatient exchange, as well as required
attestations, as specified by CMS (see
§§ 414.1365(c)(4)(i) and 414.1375(b)).
Please also refer to section IV.A.4.c.(4).
and Table 62 for required objectives and
measures for the MIPS Promoting
Interoperability performance category
for the CY 2025 performance period/
2027 MIPS payment year.
Operating within the MVP measures
framework, an ambulatory specialty
model would collect data on measures
across quality, cost, and improvement
activities performance categories that
would be clinically relevant to
specialties or sub-specialties or both
within an MVP topic specified by the
model. As discussed in III.J.1. of this
proposed rule, the model could use a
subset of measures and activities
included in an MVP that are most
clinically relevant to the model’s
clinical topics and specialties. A
clinically focused measure and activity
set could allow CMS to set performance
standards that are most clinically
relevant to sub-specialties within an
MVP topic under the model.
CMS requests the following feedback
related to incorporating measures and
activities from MVP performance
categories in a possible ambulatory
specialty model:
(6) If CMS were to reduce the number
of measures and activities in an MVP for
clinicians participating in the model to
those measures and activities most
relevant to a specified specialty or
subspecialty, how should CMS select
the measures and activities? Consider
the following prioritization approaches:
(a) measures with a performance gap; (b)
measures with meaningful benchmarks
that can be applied; (c) measures that
are reliable in the model context given
the expected sample size; (d) measures
that are evidence-based and either
strongly linked to outcomes or an
outcome measure; (e) measures that
capture an adequate number and
representativeness of the clinicians
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intended by a possible ambulatory
specialty model; (f) measures that drive
specialty integration with primary care
and meaningful involvement with
accountable entities. Are there other
measure selection principles that should
be prioritized when narrowing
measuring in an MVP?
(7) Are there specific measure focus
areas or objectives that should be
prioritized across MVPs (such as equity,
population health measures, or patientreported outcome-based performance
measures (PRO–PMs) and patientreported experience measures)?
(8) To support improvements in
primary and specialty care integration,
an ambulatory specialty model could
initially focus on specialty types eligible
to become rostered specialty care
partner clinicians in the MCP model,
which include general cardiologists and
physical medicine and rehabilitation
clinicians. Accordingly, which
measures within the Advancing Care for
Heart Disease MVP and the
Rehabilitative Support for
Musculoskeletal Care MVP might be
subset to apply to general cardiology
and physical medicine and
rehabilitation, respectively?
(9) Similar to how other Innovation
Center models may test new measures
during their implementation (for
example, the Comprehensive Joint
Replacement model (80 FR 73358
through 73382 and 86 FR 23543 through
23549) and the Guiding an Improved
Dementia Experience (GUIDE)
Model 612), what role could an
ambulatory specialty model have in
testing potential new measures, such as
relevant PRO–PMs, by gathering data for
consideration in future MVP measure
sets?
(10) What kinds of strategies could be
tested to obtain patient and family
feedback on how they experience care
coordination between primary care and
specialty care for the clinical focus areas
of the model?
(11) What types of peer engagement
would specialists consider valuable to
enhance their performance within a
given sub-specialty or clinical topic?
c. Payment Methodology
MIPS final scores are used to
determine payment adjustments for
future Medicare Part B payments during
the payment year that occurs 2 calendar
years following the MIPS performance
period (for example, scores from the CY
2021 MIPS performance period resulted
in Part B Medicare payment adjustments
for the 2023 calendar year) (see
612 https://www.cms.gov/files/document/guiderfa.pdf.
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§ 414.1305). CMS scores a MIPS eligible
clinician’s performance on measures
and activities in accordance with
section 1848(q)(5) of the Act and
regulations at §§ 414.1317, 414.1365,
414.1367, and 414.1380, as applicable to
determine a final score for each MIPS
eligible clinician.
In accordance with section 1848(q)(6)
of the Act and § 414.1405(b), CMS
compares each MIPS eligible clinician’s
final score against the performance
threshold established for that MIPS
payment year and against one another in
a single comparison pool to determine
whether each MIPS eligible clinician
will receive a positive, negative, or
neutral payment adjustment. CMS
calculates MIPS payment adjustment
factors in accordance with regulations at
§ 414.1405. Scores equal to the defined
performance threshold receive a neutral
(0 percent) payment adjustment. Scores
falling below one-quarter of the
performance threshold receive a
negative adjustment of minus 9 percent,
while scores between one-quarter of the
performance threshold and the
performance threshold receive a
negative payment adjustment less than
0 percent and up to minus 9 percent
based on a linear sliding scale. Scores
above the performance threshold can
receive positive payment adjustments
greater than 0 percent and up to positive
9 percent based on a linear sliding scale.
Depending on the range of scores within
a given performance period, a scaling
factor (ranging from 0 to 3) is applied to
positive adjustments to retain budget
neutrality.
For the CY 2022 performance period/
2024 MIPS payment year, over 624,000
clinicians received MIPS payment
adjustments to their Medicare Part B
payments based on participation in
traditional MIPS: 14 percent of MIPS
eligible clinicians received negative
MIPS payment adjustments, 7 percent
received neutral MIPS payment
adjustments, and 79 percent received
positive MIPS payment adjustments
with a maximum positive payment
adjustment of 8.26 percent.613 MVPs
were not a reporting option for the CY
2022 performance period/2024 MIPS
payment year.
As discussed in III.J.1. of this
proposed rule, an ambulatory specialty
model allow for more specific
comparisons between clinicians of the
613 QPP 2022 Participation Results At-a-Glance
https://qpp-cm-prod-content.s3.amazonaws.com/
uploads/2816/QPP-2022-Participation-andPerformance-Results-At-A-Glance.pdf. Note that for
the CY 2022 performance period, MIPS participants
were eligible for an additional MIPS payment
adjustment factor for exceptional performance (see
§ 414.1405).
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same type who are providing similar
services to patients. Comparing
clinicians that provide a similar type of
specialty care to determine future
Medicare Part B payment adjustments
could lead to payment adjustments that
are more reflective of the range of
performance of similar clinicians caring
for beneficiaries within a given clinical
topic area. Such comparisons could
create financial incentives that drive
quality improvement and care
transformation within a given clinical
topic and specialty. Further, a more
targeted approach to performance
measurement and assessment, including
enhanced data on clinical and financial
performance relative to similar
clinicians, could incentivize shared
accountability for care and lead to
increased beneficiary access to
coordinated specialty care.
In considering an ambulatory
specialty model that leverages the MVP
framework to increase specialist
engagement in value-based care and
transform specialist care delivery, CMS
is requesting feedback on the following
questions:
(12) How could a model for applicable
specialists improve the comparison of
similar specialists to determine future
Medicare Part B payment adjustments?
(13) What range of upside and
downside risk (as measured by the range
of possible payment adjustments to
future Medicare Part B claims) could
incentivize increased and meaningful
participation of specialists in APMs,
care transformation, and strengthened
integration between primary and
specialty care?
(14) What model design features
should CMS consider in designing an
ambulatory specialty care model that
increases risk over time to potentially
qualify the model for Advanced APM
(AAPM) status under the Quality
Payment Program (see § 414.1415)?
d. Care Delivery and Incentives for
Partnerships With Accountable Care
Entities and Integration With Primary
Care
CMS is exploring how an ambulatory
specialty model could encourage model
participants to better engage with
primary care providers engaged in care
coordination activities in the MCP
model, Shared Savings Program, and
other current and future accountable
care models. By promoting coordination
and partnership between specialists and
these accountable entities, CMS seeks to
extend opportunities for specialists to
deliver comprehensive longitudinal care
and improve the quality of care
provided by both parties. For example,
CMS could test the inclusion of new
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improvement activities in model MVPs
that are fulfilled through care
coordination activities with an
accountable care entity or its participant
clinicians. As CMS considers
opportunities to encourage specialist
delivery of comprehensive longitudinal
care, an underlying priority is care
delivery from the beneficiary’s
perspective. To address the issue of
highly fragmented care delivery to the
beneficiary, CMS recognizes the need
for meaningful engagement among those
who deliver care and seeks to create
incentives for partnerships between
specialist clinicians, accountable care
entities, and primary care clinicians. To
help us ensure these accountable
entities reduce fragmentation and
provide patients with the highest value
care, we seek input on the following
questions:
(15) Are there model design features
not discussed here that would
incentivize primary care and specialty
care providers to improve how
beneficiaries experience care
coordination?
(16) How can CMS best encourage
specialist clinicians and accountable
care entities collaborate to establish
clear care pathways and protocols that
optimize patient outcomes while
ensuring efficient resource utilization?
(17) How may CMS identify
specialists who are most engaged in care
management, care coordination, and
care improvement activities with an
accountable care entity?
(18) In what ways can the model
define clear expectations and
performance metrics for specialists,
beyond what exists in the current MVP
measure sets, to foster a collaborative
environment with ACOs and primary
care clinicians to enhance healthcare
outcomes and reduce costs? What
levers, such as the MIPS’s Improvement
Activities, could be used to support
participants to close the care loop back
to accountable care entities or primary
care or both?
(19) What characteristics should CMS
consider in the design of this model to
account for variations between ACOs,
such as whether the ACO is physicianowned versus hospital-owned (or a low
revenue ACO versus a high revenue
ACO), whether or not an ACO identifies
as an integrated delivery system (IDS),
and differences in regional healthcare
landscapes and local dynamics? What
other characteristics should we
consider?
(20) How can the model proactively
address concerns related to increased
consolidation, ensuring that integration
efforts do not lead to reduced
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competition and potential negative
impacts on healthcare quality and costs?
(21) How might risk categorization of
ACOs influence the design of incentive
structures of model participants
engaging with ACOs, and what
adjustments might be necessary to
accommodate different risk levels?
e. Health Information Technology and
Data Sharing
The Quality Payment Program
releases publicly the QPP Experience
Report Public Use Files (with
companion methodology and data
dictionary documentation), which allow
users to review details concerning
participation and performance
information in the MIPS program during
each performance period. These files
cover eligibility and participation,
performance categories, and final score
and payment adjustments, with details
at the TIN/NPI level on each of the
performance categories for the previous
performance period. Data can be sorted
by variables like clinician type, practice
size, scores, and payment adjustments.
Clinicians and authorized
representatives of practices, virtual
groups, and APM Entities (including
Shared Savings Program ACOs) also
have access to summaries of data that
they have submitted and that CMS has
collected on their behalf. This includes
performance category-level scores and
weights, bonus points, measure-level
performance data and scores, activitylevel scores, payment adjustment
information, and patient-level reports.
Clinicians frequently request more
timely and expansive data feedback
through MIPS to help guide continuous
improvement efforts. CMS requests the
following feedback on health
information technology and data
sharing:
(22) What specific issues should CMS
consider when determining whether
additional requirements and objectives
may be necessary beyond those
currently specified in the MVP
framework around the use of health IT
by specialists participating in a
potential model?
(23) What investments in health IT or
information exchange would be most
beneficial to helping specialists succeed
in such a model?
(24) What is your experience with the
integration of health IT systems? Please
highlight any interoperability issues or
opportunities for seamless data
exchange between different systems,
such as electronic health records (EHRs)
and telehealth platforms.
(25) How should CMS structure the
model and any health IT and data
sharing requirements to align with,
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build upon, and otherwise leverage
advances in Federal interoperability
policy (for example, USCDI and USCDI+
or FHIR; TEFCA)?
(26) What data or metrics or both are
important to clinicians in terms of
monitoring performance and improving
patient outcomes? What data or metrics
or both should CMS share publicly to
help inform beneficiaries of clinician
performance?
(27) What additional resources or
support mechanisms could CMS
provide to help clinicians make sense of
the data, enhancing the data’s usability,
effectiveness, and frequency of updates,
so that clinicians acquire actionable
insights for improving patient care and
experience? And to enable data-driven
referrals?
(28) What supports can this new
model provide for decreasing burden of
data collection and measure reporting?
f. Health Equity
Disparities in access to ambulatory
specialty care and chronic condition
outcomes are well documented, such as
racial/ethnic and geographic disparities
in rates of ischemic heart disease (IHD)
among Medicare fee-for-service
beneficiaries.614 For example, Medicare
fee-for-service beneficiaries identifying
as American Indian/Alaska Native (28
percent) had the highest agestandardized prevalence of IHD and
Asian/Pacific Islander (22 percent)
beneficiaries had the lowest prevalence,
compared to the IHD prevalence among
White (27 percent), Black/African
American (26 percent), and Hispanic (25
percent) beneficiaries in 2021.615
Medicare fee-for-service beneficiaries
with complex chronic conditions in
rural areas have also been shown to
have comparable access to primary care
physicians but significantly lower
access to ambulatory specialists and
higher rates of avoidable
hospitalizations for chronic conditions
compared to similar beneficiaries in
urban areas.616 Engaging specialists in
value-based care to create more
integrated and efficient care provides an
for Medicare & Medicaid Services.
Ischemic Heart Disease Disparities in Medicare Feefor-Service Beneficiaries Data Snapshot. April 2021.
https://www.cms.gov/About-CMS/AgencyInformation/OMH/Downloads/OMH_DwnldDataSnashot-Ischemic-Heart-Disease.pdf.
615 Centers for Medicare & Medicaid Services.
Ischemic Heart Disease Disparities in Medicare Feefor-Service Beneficiaries Data Snapshot. April 2021.
https://www.cms.gov/About-CMS/AgencyInformation/OMH/Downloads/OMH_DwnldDataSnashot-Ischemic-Heart-Disease.pdf.
616 Johnston KJ, Wen H, Joynt Maddox KE. Lack
Of Access to Specialists Associated with Mortality
and Preventable Hospitalizations of Rural Medicare
Beneficiaries. Health Aff (Millwood). 2019;38(12):
1993–2002. doi: 10.1377/hlthaff.2019.00838.
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opportunity to expand access to
specialty care for historically
underserved beneficiaries and advance
health equity.
Consistent with President Biden’s
Executive Order 13985 on ‘‘Advancing
Racial Equity and Support for
Underserved Communities Through the
Federal Government’’ (86 FR 7009) and
Executive Order 14091 on ‘‘Further
Advancing Racial Equity and Support
for Underserved Communities Through
the Federal Government’’ (88 FR 10825),
CMS has made advancing health
equity 617 the first pillar in its Strategic
Plan. Health equity is also one of the
five objectives in the Innovation
Center’s 2021 Strategy Refresh.
Improving access to high-quality,
patient-centered care is a goal for the
Innovation Center, and ensuring
historically underserved beneficiaries
are adequately represented in valuebased care models may help reduce
inequities when designed with the
proper incentives.
The Innovation Center is also
committed to prioritizing the unique
needs of clinicians that care for a large
proportion of underserved populations,
such as creating flexibilities clinicians
may need to be successful in models. To
advance health equity goals within
payment models, the Innovation Center
has implemented multiple equityfocused strategies within existing
models, including, but not limited to
development of participant health
equity plans, reporting of aggregated
health-related social need (HRSN)
screening,618 reporting and analysis of
attributed beneficiary sociodemographic
data to support identification and
monitoring of health disparities, and
payment adjustments.
Within the MVP framework, several
MVPs include equity-focused measures
within the quality and improvement
activities performance categories, such
as screening for HRSNs or engaging
community resources to address HRSNs.
MVPs also provide additional reporting
617 We define health equity as the attainment of
the highest level of health for all people, where
everyone has a fair and just opportunity to attain
their optimal health regardless of race, ethnicity,
disability, sexual orientation, gender identity,
socioeconomic status, geography, preferred
language, and other factors that affect access to care
and health outcomes.
618 Health-related social needs are adverse social
conditions that negatively impact a person’s health
or healthcare such as lack of access to
transportation for appointments. See A Guide to
Using the Accountable Health Communities HealthRelated Social Needs Screening Tools: Promising
Practices and Key Insights. CMS. (Updated Aug.
2022). https://www.cms.gov/priorities/innovation/
media/document/ahcm-screeningtool-companion;
Accountable Health Communities Health-Related
Social Needs Screening Tool.
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and scoring flexibilities for certain
special status designations, many of
which may include clinicians caring for
historically underserved beneficiaries.
There may be additional clinician- and
practice-level characteristics, including
the characteristics of beneficiaries
served, that would be important to
account for within an ambulatory
specialty model to support clinicians in
identifying and working to improve
disparities related to access to specialty
care and associated outcomes.
To understand the potential health
equity impacts of a new ambulatory
specialty model and to help ensure the
goals laid out in the CMS Strategic Plan
and the Innovation Center Strategy
Refresh are met, we request feedback on
the following questions:
(29) Similar to how other Innovation
Center models may offer financial and
technical supports to certain qualifying
clinicians (for example, safety net
clinicians) as part of a model’s health
equity strategy (for example, the GUIDE
model 619), how might CMS support the
participation of clinicians in an
ambulatory specialty model that may
serve a higher proportion of
underserved patients (for example,
small practices or clinicians in rural
areas)?
(30) How could an ambulatory
specialty model support participant
efforts to identify health disparities
within their practices, identify
actionable equity goals, and design and
implement strategies to improve
identified disparities?
(31) How could an ambulatory
specialty focused model work
synergistically with other primary care
focused models to improve health
disparities?
(32) How could an ambulatory
specialty model encourage clinicians to
collect and use HRSN screening and
follow-up data collected on patients
attributed to the model?
(33) How can measure stratification
among patient subgroups or use of
composite health equity measures
improve how participants identifies and
quantifies potential disparities in care
and outcomes related to ambulatory
specialty care?
g. Multi-Payer Alignment
Given the Innovation Center’s
strategic goal to make multi-payer
alignment available in all new models
by 2030,620 we are seeking feedback on
619 Center for Medicare and Medicaid Services.
Guiding an Improved Dementia Experience (GUIDE)
Model. https://www.cms.gov/priorities/innovation/
innovation-models/guide.
620 Centers for Medicare and Medicaid Services.
Driving Health System Transformation—A Strategy
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how to best promote multi-payer
alignment between a potential
ambulatory model, established models
and programs, and payers to achieve
sustainable system-wide transformation.
The increased engagement in valuebased care proposed in the model could
support other payers like Medicare
Advantage, Medicaid, and commercial
plans in achieving their goals around
value-based care activities by providing
an onramp for specialists inexperienced
with this form of payment. Also,
leveraging existing design principles
from MIPS promotes directional
alignment as they adhere to the broader
CMS National Quality Strategy,
including an effort to move toward
digital quality measurement,621 and
plans to employ a ‘‘Universal
Foundation’’ of quality measures to
create greater consistency in quality
reporting across payers.622
We request feedback on the following
questions:
(34) Are there opportunities to reduce
clinician burden between this model,
other CMMI models, and beyond
through multi-payer alignment, in areas
such as performance measurement,
quality measurement, and data/
reporting requirements?
(35) How could this model align with
value-based care approaches in the
Medicare Advantage, Medicaid, and
commercial payer space that focus on
specialty integration? What model
components and payment incentives
can be aligned with other payers to
support improvement goals?
(36) How can CMS align with other
payer approaches to equity and
disparity reduction? This could include
alignment on definitions, methods, and
requirements for equity-related data
collection, etc.
(37) What technical assistance can
CMS provide to support alignment and
reduce burden?
K. Expand Colorectal Cancer Screening
Medicare coverage for colorectal
cancer (CRC) screening tests under Part
B are described in statutes (sections
1861(s)(2)(R), 1861(pp), 1862(a)(1)(H)
and 1834(d) of the Social Security Act
(the Act)), regulation (42 CFR 410.37),
and National Coverage Determination
(NCD) (Section 210.3 of the Medicare
for the CMS Innovation Center’s Second Decade.
October 2021. https://www.cms.gov/priorities/
innovation/strategic-direction-whitepaper.
621 Centers for Medicare and Medicaid Services.
dQMs—Digital Quality Measures. dQM Strategic
Roadmap.
622 Jacobs DB, Schreiber M, Seshamani M, Tsai D,
Fowler E, Fleisher LA. Aligning Quality Measures
across CMS—The Universal Foundation. 2023. New
England Journal of Medicine, 388 (9), 776–779. DOI:
10.1056/NEJMp2215539.
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National Coverage Determinations
Manual). The statute and regulations
expressly authorize the Secretary to add
other tests and procedures (and
modifications to tests and procedures)
for colorectal cancer screening with
such frequency and payment limits as
the Secretary finds appropriate based on
consultation with appropriate
organizations. (Section 1861(pp)(1)(D) of
the Act; § 410.37(a)(1)(v)) We are
proposing to exercise our authority at
section 1861(pp)(1)(D) of the Act to
update and expand coverage for CRC
screening by:
• Removing coverage for the barium
enema procedure in regulations at
§ 410.37,
• Adding coverage for the computed
tomography colonography (CTC)
procedure in regulations at § 410.37,
and
• Expanding a ‘‘complete colorectal
cancer screening’’ in § 410.37(k) to
include a follow-on screening
colonoscopy after a Medicare covered
blood-based biomarker CRC screening
test (described and authorized in NCD
210.3).
1. Background
The Center for Disease Control and
Prevention (CDC) describes CRC as ‘‘a
disease in which cells in the colon or
rectum grow out of control . . .
Sometimes abnormal growths, called
polyps, form in the colon or rectum.
Over time, some polyps may turn into
cancer. Screening tests can find polyps
so they can be removed before turning
into cancer. Screening also helps find
colorectal cancer at an early stage, when
treatment works best.’’ 623 The National
Cancer Institute reports that CRC is the
fourth most common type of cancer and
estimates that the United States
experienced 153,020 new cases and
52,550 new deaths from CRC in 2023. In
addition, the rate of new cases and new
deaths from CRC is more common in
men than women and significantly
greater for those of African American
and Non-Hispanic American Indian/
Alaska Native descent compared to all
races.624
At § 410.37(a)(4), we define the
barium enema procedure as a screening
double contrast barium enema of the
entire colorectum (including a
physician’s interpretation of the results
of the procedure); or in the case of an
individual whose attending physician
decides that he or she cannot tolerate a
screening double contrast barium
623 CDC website: https://www.cdc.gov/cancer/
colorectal/basic_info/what-is-colorectal-cancer.htm.
624 NCI website: https://seer.cancer.gov/statfacts/
html/colorect.html.
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enema, a screening single contrast
barium enema of the entire colorectum
(including a physician’s interpretation
of the results of the procedure). The
CDC describes CTC, (also called a
virtual colonoscopy), as ‘‘a screening
test that uses X-rays and computers to
produce images of the entire colon,
which are displayed on a computer
screen for the doctor to analyze.’’ 625
The U.S. Preventative Services Task
Force (USPSTF) included CTC as a CRC
screening method in their June 2016
revised Final Recommendation
Statement which included the topline
recommendations ‘‘[t]he USPSTF
recommends the (CRC screening)
service. There is high certainty that the
net benefit is substantial (Grade A)’’ and
‘‘[t]he USPSTF recommends the (CRC
screening) service. There is high
certainty that the net benefit is
moderate, or there is moderate certainty
that the net benefit is moderate to
substantial) (Grade B)’’.626 The USPSTF
cautioned, ‘‘[t]here is insufficient
evidence about the potential harms of
associated extracolonic findings, which
are common.’’ The USPSTF further
wrote, ‘‘[t]here are numerous screening
tests to detect early-stage colorectal
cancer, including stool-based tests
(gFOBT, FIT, and FIT–DNA), direct
visualization tests (flexible
sigmoidoscopy, alone or combined with
FIT; colonoscopy; and CT
colonography), and serology tests
(SEPT9 DNA test). The USPSTF found
no head-to-head studies demonstrating
that any of these screening strategies are
more effective than others, although
they have varying levels of evidence
supporting their effectiveness, as well as
different strengths and limitations.’’ 627
The USPSTF again included CTC as a
CRC screening method in the most
recent May 2021 revised Final
Recommendation Statement, which
included the topline recommendations
‘‘[t]he USPSTF recommends screening
for colorectal cancer in all adults aged
50 to 75 years (Grade A)’’ and ‘‘[t]he
USPSTF recommends screening for
colorectal cancer in adults aged 45 to 49
years (Grade B)’’.628 CMS describes our
625 CDC website: https://www.cdc.gov/cancer/
colorectal/basic_info/screening/tests.htm.
626 USPSTF June 2016 Revised Final
Recommendation Statement https://
www.uspreventiveservicestaskforce.org/uspstf/
recommendation/colorectal-cancer-screening-june2016.
627 USPSTF June 2016 Revised Final
Recommendation Statement https://
www.uspreventiveservicestaskforce.org/uspstf/
recommendation/colorectal-cancer-screening-june2016.
628 USPSTF January 2021 Revised Final
Recommendation Statement https://
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consultations with additional
organizations and our review of clinical
guidelines later in our proposal.
2. Statutory Authority
Section 4104 of the Balanced Budget
Act of 1997 (Pub. L. 105–33) authorized
the benefit colorectal cancer screening
tests under Medicare Part B. Section
1861(s)(2)(R) of the Act includes CRC
screening tests in the definition of
medical and other health services that
fall within the scope of Medicare Part B
benefits described in section 1832(a)(1)
of the Act. Section 1861(pp) of the Act
defines colorectal cancer screening tests
and specifically names the following
tests:
• Screening fecal-occult blood test;
• Screening flexible sigmoidoscopy;
and
• Screening colonoscopy.
Section 1861(pp)(1)(D) of the Act also
authorizes the Secretary to include in
the definition of CRC screening tests
other tests or procedures and
modifications to the tests and
procedures described under this
subsection, with such frequency and
payment limits as the Secretary
determines appropriate, in consultation
with appropriate organizations.
3. Regulatory and NCD Authority
In the CY 1998 PFS final rule (62 FR
59048), after consulting with
appropriate organizations, we finalized
regulations to cover barium enema
procedures for CRC screening in
§ 410.37. Barium enema screening
examinations have to be ordered by the
beneficiary’s attending physician
(§ 410.37(h)). Currently, the regulations
cover barium enemas as a CRC
screening tests subject to frequency
limitations and whether or not the
individual was at high risk for colorectal
cancer. As described in the CY 1998
PFS final rule (62 FR 59048), CMS
consulted with a number of appropriate
organizations such as the American
Cancer Society, American College of
Physicians, American
Gastroenterological Association and
U.S. Preventive Services Task Force
(USPSTF) and the decision to cover the
barium enema procedure was based on
the prevailing clinical guidelines and
recommendations at the time. In the CY
2023 PFS final rule (87 FR 69404), we
lowered the age limit for barium enema
procedures for CRC screening to age 45
at § 410.37(i)(1).
In May 2009, we established a noncoverage policy for CTC in NCD 210.3
CTC Screening Tests. We noted in the
www.uspreventiveservicestaskforce.org/uspstf/
recommendation/colorectal-cancer-screening.
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Final Decision Memorandum, ‘‘there is
insufficient evidence on the test
characteristics and performance of
screening CT colonography in Medicare
aged individuals and that the evidence
is not sufficient to conclude that
screening CT colonography improves
health benefits for asymptomatic,
average risk Medicare beneficiaries.’’ 629
At that time, the October 2008 USPSTF
revised Final Recommendation
Statement read, ‘‘[t]he USPSTF
concludes that the evidence is
insufficient to assess the benefits and
harms of computed tomographic
colonography and fecal DNA testing as
screening modalities for colorectal
cancer. (Grade I)’’ 630 As described in
the Final Decision Memo, guidelines
from Professional Societies were mixed.
A joint guideline from the American
Cancer Society, the U.S. Multi-Society
Task Force on Colorectal Cancer, and
the American College of Radiology
concluded ‘‘[i]n terms of detection of
colon cancer and advanced neoplasia,
which is the primary goal of screening
for CRC and adenomatous polyps,
recent data suggest CTC is comparable
to Optical Colonoscopy for the detection
of cancer and polyps of significant size
when state-of-the-art techniques are
applied.’’ 631 The American
Gastroenterological Association issued
the following recommendation
statement in 2008, ‘‘[t]he AGA does not
endorse CT colonography as a first-line
colon cancer screening test. While AGA
supports CT colonography as a
screening option, colonoscopy is the
definitive test for colorectal cancer
screening and prevention. Colonoscopy
is the only test that can both detect
cancer at an early curable stage and
prevent cancer by removing precancerous polyps. At this time, while
CT colonography may be another
technology for colorectal cancer
screening, many questions about CT
colonography remain to be
629 National Coverage Analysis CAG–00396N
Screening Computed Tomography Colonography
(CTC) for Colorectal Cancer on Medicare Coverage
Database (https://www.cms.gov/medicare-coveragedatabase/view/ncacal-decisionmemo.aspx?proposed=
N&NCAId=220&NcaName=Screening+
Computed+Tomography+Colonography+
(CTC)+for+Colorectal+Cancer),).
630 USPSTF October 2008 Final Recommendation
Statement: https://
www.uspreventiveservicestaskforce.org/uspstf/
recommendation/colorectal-cancer-screening-2008.
631 National Coverage Analysis CAG–00396N
Screening Computed Tomography Colonography
(CTC) for Colorectal Cancer on Medicare Coverage
Database: https://www.cms.gov/medicare-coveragedatabase/view/ncacal-decisionmemo.aspx?proposed=N&
NCAId=220&NcaName=Screening+
Computed+Tomography+Colonography+
(CTC)+for+Colorectal+Cancer).
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answered.’’ 632 The American Society
for Gastrointestinal Endoscopy
published guidelines in 2006 that
concluded ‘‘virtual colonoscopy is an
evolving technique and is not currently
recommended as the primary method of
screening for CRC.’’ 633
In the 2023 PFS final rule (87 FR
69404) we expanded the regulatory
definition of CRC Screening to include
a complete colorectal cancer screening,
which includes a follow-on screening
colonoscopy after a Medicare covered
non-invasive stool-based colorectal
cancer screening test returns a positive
result. (§ 410.37(k)) Although CMS had
previously viewed a colonoscopy after a
positive non-invasive stool-based CRC
screening test to be a diagnostic
colonoscopy, the clinical
recommendations and guidance of
medical professional societies and
screening experts have since evolved for
stool-based colorectal cancer screening
due to the relative number of false
positive results, low follow-up
colonoscopy rates and patient access
barriers. Published evidence highlighted
that individuals who did not get a
follow-up colonoscopy were about twice
as likely to die of colorectal cancer
compared to individuals who had one.
Since the overall goal of programmatic
cancer screening using any CRC
screening test is to prevent cancer,
allowing for early detection and
treatment and reducing cancer
mortality, the follow-up colonoscopy
was found to be integral with noninvasive stool-based CRC screening,
since improvements in health outcomes
would not be possible without the
follow-up colonoscopy. Our goal was
that the patient and their healthcare
professional make the most appropriate
choice in CRC screening, which
included considerations of the risks,
burdens and barriers presented with an
invasive screening colonoscopy in a
clinical setting as their first step. We
went on to describe that CRC screening
presents a unique scenario where there
are significant differences between
632 National Coverage Analysis CAG–00396N
Screening Computed Tomography Colonography
(CTC) for Colorectal Cancer on Medicare Coverage
Database: https://www.cms.gov/medicare-coveragedatabase/view/ncacal-decisionmemo.aspx?proposed=N&
NCAId=220&NcaName=Screening+
Computed+Tomography+Colonography+
(CTC)+for+Colorectal+Cancer).
633 National Coverage Analysis CAG–00396N
Screening Computed Tomography Colonography
(CTC) for Colorectal Cancer on Medicare Coverage
Database: https://www.cms.gov/medicare-coveragedatabase/view/ncacal-decisionmemo.aspx?proposed=N&
NCAId=220&NcaName=Screening+
Computed+Tomography+Colonography+
(CTC)+for+Colorectal+Cancer).
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screening stool-based tests and
screening colonoscopy tests in terms of
invasiveness and burdens to the patient
and healthcare system. We recognized
there are several advantages to choosing
a non-invasive stool-based CRC
screening test as a first step compared
to a screening colonoscopy, including
relative ease of administering the test
and potentially reducing the experience
of unnecessary burdensome preparation
and invasive procedures.
We noted in preamble of the CY 2023
PFS final rule (87 FR 69404) that many
commenters asked that CMS further
expand our approach of a complete
colorectal cancer screening. Many
requested that we remove the text
‘‘stool-based’’ from our proposed
regulatory text at § 410.37(k), resulting
in a complete CRC screening including
a follow-on screening colonoscopy after
a Medicare covered non-invasive
screening test. Many commenters
requested that a complete CRC
screening include a screening
colonoscopy after a positive result from
a blood-based biomarker test, as well as
a stool-based test. We responded to
these public comments by writing that
‘‘we disagree with the commenters that
requested a further expansion of a
complete colorectal cancer screening
that would include additional first step
tests beyond a non-invasive stool-based
test. We believe the stool-based tests are
unique to other CRC screening tests in
terms of their non-invasiveness, the fact
that stool-based tests can be
implemented by the patient at home and
mailed into the lab, the absence of
bowel preparation and anesthesia and
the comparatively lighter burden and
mitigated potential for over servicing of
the patient and the healthcare system.’’
We further wrote, ‘‘[w]e agree that
blood-based biomarker CRC screening
tests have significant potential and we
expanded coverage to include them in
the reconsidered NCD 210.3, effective
January 2021.’’ We also recognized that
blood-based biomarker CRC screening
tests continue to be an emerging and
quickly evolving technology. However,
we also noted that, as of September
2022, no blood-based Biomarker tests
for CRC screening had achieved the
coverage requirements of NCD 210.3
and that the May 2021 USPSTF revised
Final Recommendation Statement did
not include serum tests.
In the CY 2023 PFS final rule (87 FR
69404) we also established regulatory
text at § 410.37(k) that the frequency
limitations described for screening
colonoscopy shall not apply in the
instance of a follow-on screening
colonoscopy test. We wrote that we
aimed to avoid disruption to the
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existing conditions of coverage and
payment for CRC screening for this
unique scenario and continuum of
screening.
4. Proposed Revisions
We propose to exercise our authority
in section 1861(pp)(1)(D) of the Act to
remove coverage for the barium enema
procedure from CRC screening in
regulations at § 410.37. CMS has
consulted with appropriate
organizations and has heard that, while
the barium enema procedure was
reasonable and necessary for CRC
screening when it was initially covered
in the CY 1998 PFS final rule (62 FR
59048), circumstances have changed.
The organizations have expressed that
barium enema procedures no longer
meet modern clinical standards, are no
longer recommended in clinical
guidelines, and would not be an
appropriate CRC screening test given the
advancement of alternatives such as
Stool-based tests, Colonoscopies, and
CT Colonography. In developing our
proposal, we also considered that June
2016 and the May 2021 USPSTF revised
Final Recommendation Statements did
not include the barium enema
procedure as a CRC screening method in
their revised Final Recommendation
Statements.634 635 We also considered
the 2017 U.S. Multi-Society Task Force
of Colorectal Cancer (MSTF)
recommendation statement, which
reads, ‘‘CT colonography has replaced
double-contrast barium enema as the
test of choice for colorectal imaging for
nearly all indications. CT colonography
is more effective than barium enema
and better tolerated.’’ 636 The 2018
American Cancer Society (ACS)
Colorectal Cancer Screening for
Average-Risk Adults Guideline Update
also reads, ‘‘double-contrast barium
enema is no longer included as an
acceptable screening option.’’ 637
During the CY 2023 PFS, CMS
received a joint public comment from
the American College of
Gastroenterology (ACG), American
Gastroenterological Association (AGA)
and the American Society for
634 USPSTF June 2016 Revised Final
Recommendation Statement, https://
www.uspreventiveservicestaskforce.org/uspstf/
recommendation/colorectal-cancer-screening-june2016.
635 USPSTF January 2021 Revised Final
Recommendation Statement, https://
www.uspreventiveservicestaskforce.org/uspstf/
recommendation/colorectal-cancer-screening.
636 Am J Gastroenterol 2017; 112:1016–1030; doi:
10.1038/ajg.2017.174; published online 6 June
2017.
637 doi: 10.3322/caac.21457. Available online at
cacancerjournal.com.
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Gastrointestinal Endoscopy (ASGE) 638
that brought to our attention that barium
enema is not a recommended CRC
screening modality in guidance from the
USPSTF or the U.S. Multi-Society Task
Force on Colorectal Cancer. The public
comment went on to note that while the
Barium Enema procedure once was
considered a CRC screening modality
and has been included in guidelines in
the past, barium enema is no longer
included in any recent CRC guidelines
and is rarely performed today as it is
considered inadequate for the exclusion
of CRC. They urged CMS to remove
Barium Enema as a covered CRC
screening test for all individuals. An
internal claims analysis indicates that
Medicare only paid claims for barium
enema for CRC screening for 72
beneficiaries in CY 2022.
A 2016 study titled ‘‘[n]ew era of
colorectal cancer screening,’’ states,
‘‘double-contrast barium enema (DCBE)
is a non-invasive radiological test,
which provides a complete evaluation
of the large intestine. The sensitivity
and specificity of barium enema for
polyps of any size is 38 percent and 86
percent, respectively. One study
comparing barium enema to CTC and
colonoscopy showed that DCBE has the
lowest sensitivity and specificity with
sensitivity of 41 percent for lesions ≥6
mm and sensitivity and specificity of 48
and 90 percent respectively for lesions
≥10 mm. These results are consistent
with a meta-analysis comparing the
performance of barium enema to that of
CTC showing CTC is more sensitive and
more specific than barium enema for
large polyps (≥10 mm) and small polyps
(6–9 mm) in average-risk and high-risk
populations. In the United States, CTC
has largely replaced DCBE as a
radiographic option for CRC
screening.’’ 639
In light of the new evidence and our
consultations with appropriate
organizations, we are proposing to
remove barium enema as a colorectal
screening test under 42 CFR
410.37(a)(1)(iv). We look forward to
further consultation with the public and
appropriate organizations through the
public comment period of this proposed
rule. We invite public comment on this
proposal to remove all references to
barium enemas in § 410.37.
We also propose to exercise our
authority in section 1861(pp)(1)(D) of
the Act to add coverage for the CTC
638 CY 2023 PFS Public Comment CMS–2022–
0113–21851_attachment_1.
639 El Zoghbi M, Cummings LC. New era of
colorectal cancer screening. World J Gastrointest
Endosc. 2016 Mar 10;8(5):252–8. doi: 10.4253/
wjge.v8.i5.252. PMID: 26981176; PMCID:
PMC4781905.
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procedure for CRC screening in
regulations at § 410.37. If finalized, we
will also address and revise the current
non-coverage policy for CTC in NCD
210.3. In developing our proposal to
expand coverage for the CTC procedure,
we consulted with appropriate
organizations and considered a number
of potential benefits, risks and tradeoffs
described in guidelines and
recommendations by professional
societies and government bodies.
In developing the proposed rule, we
considered that the USPSTF included
the CTC procedure as a CRC screening
method in their June 2016 and May
2021 revised Final Recommendation
Statements.640 641 In terms of benefits,
the USPSTF wrote in their May 2021
revised Final Recommendation
Statement, that CTC usually allows for
greater colon visualization compared to
Flexible Sigmoidoscopy. In terms of
risks and tradeoffs, USPSTF noted that
CTC, like Colonoscopy and flexible
sigmoidoscopy, requires the burden of
bowel preparation. The USPSTF wrote
‘‘[u]nlike Colonoscopy and Flexible
Sigmoidoscopy, CTC may reveal
extracolonic findings that require
additional workup, which could lead to
other potential benefits or harms.’’ The
USPSTF went on to state, ‘‘[h]arms from
CT colonography are uncommon (19
studies; n = 90,133), and the reported
radiation dose for CT colonography
ranges from 0.8 to 5.3 mSv (compared
with an average annual background
radiation dose of 3.0 mSv per person in
the U.S.). Accurate estimates of rates of
serious harms from colonoscopy
following abnormal CTC results are not
available.’’ Regarding extracolonic
findings, the USPSTF wrote,
‘‘[e]xtracolonic findings on CTC are
common. Based on 27 studies that
included 48,235 participants, 1.3
percent to 11.4 percent of examinations
identified extracolonic findings that
required workup. Three percent or less
of individuals with extracolonic
findings required definitive medical or
surgical treatment for an incidental
finding. A few studies suggest that
extracolonic findings may be more
common in older age groups. Long-term
clinical follow-up of extracolonic
findings was reported in few studies,
making it difficult to know whether it
represents a benefit or harm of CT
640 USPSTF June 2016 Revised Final
Recommendation Statement, https://
www.uspreventiveservicestaskforce.org/uspstf/
recommendation/colorectal-cancer-screening-june2016.
641 USPSTF January 2021 Revised Final
Recommendation Statement, https://
www.uspreventiveservicestaskforce.org/uspstf/
recommendation/colorectal-cancer-screening.
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colonography.’’ The USPSTF
recommends screening CTC frequency
of every 5 years.642
In a study titled ‘‘Incidental
Extracolonic Findings on CT
Colonography: The Impending Deluge
and Its Implications,’’ Lincoln L.
Berland, MD, describes extracolonic
findings as findings on CTC that have
potential deleterious health effects and
are asymptomatic, unsuspected, and
unrelated to the colon. The study goes
on to state, ‘‘as CT image quality has
improved, there has been an increase in
the frequency of detecting ‘incidental
findings,’ defined as findings that are
unrelated to the clinical indication for
the imaging examination performed.
These ‘incidentalomas,’ as they are also
called, often confound physicians and
patients with how to manage them.
Although it is known that most
incidental findings are likely benign and
often have little or no clinical
significance, the inclination to evaluate
them is often driven by physician and
patient unwillingness to accept
uncertainty, even given the rare
possibility of an important
diagnosis.’’ 643 The potential for
extracolonic findings, both clinically
significant and insignificant, is an
important tradeoff to be considered by
the patient and clinician when
considering CTC as a CRC Screening
option.
We also consider the 2018 ACS
Colorectal Cancer Screening for
Average-Risk Adults Guideline Update,
which includes the CTC procedure with
their recommended tests and
procedures for CRC Screening.644 In
terms of benefits, the ACS guideline
describes CTC Sensitivity and
specificity for cancer and advanced
adenomas comparable to colonoscopy,
longer recommended screening intervals
compared to stool-based tests, and no
need for sedation (compared to
colonoscopy). In terms of risks and
tradeoffs, the ACS guideline notes
incidental extracolonic findings may
require workup (with unclear benefitburden balance), exposure to low-dose
radiation and requires full bowel
cleansing. The ACS guidelines
642 USPSTF January 2021 Revised Final
Recommendation Statement, https://
www.uspreventiveservicestaskforce.org/uspstf/
recommendation/colorectal-cancer-screening.
643 Lincoln L. Berland, Incidental Extracolonic
Findings on CT Colonography: The Impending
Deluge and Its Implications, Journal of the
American College of Radiology, Volume 6, Issue 1,
2009, Pages 14–20, ISSN 1546–1440, https://
doi.org/10.1016/j.jacr.2008.06.018.
644 doi: 10.3322/caac.21457. Available online at
cacancerjournal.com.
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recommended screening CTC frequency
of every 5 years.
We also consider the United States
Multi-Society Task Force (MSTF) of
Colorectal Cancer, which represents the
American College of Gastroenterology,
the American Gastroenterological
Association, and The American Society
for Gastrointestinal Endoscopy, 2017
Colorectal Cancer Screening
recommendations,645 which include
CTC as a ‘‘Tier 2’’ procedure alongside
FIT-fecal DNA and Flexible
Sigmoidoscopy. The recommendation
states that ‘‘CRC screening tests are
ranked in 3 tiers based on performance
features, costs, and practical
considerations. The first-tier tests are
colonoscopy every 10 years and annual
fecal immunochemical test (FIT).
Colonoscopy and FIT are recommended
as the cornerstones of screening
regardless of how screening is offered.
Thus, in a sequential approach based on
colonoscopy offered first, FIT should be
offered to patients who decline
colonoscopy. Colonoscopy and FIT are
recommended as tests of choice when
multiple options are presented as
alternatives. A risk-stratified approach
is also appropriate, with FIT screening
in populations with an estimated low
prevalence of advanced neoplasia and
colonoscopy screening in high
prevalence populations. The second-tier
tests include CT colonography every 5
years, the FIT-fecal DNA test every 3
years, and flexible sigmoidoscopy every
5 to 10 years. These tests are appropriate
screening tests, but each has
disadvantages relative to the tier 1
tests.’’ In terms of benefits of CTC, the
MSTF describes lower risk of
perforation compared with colonoscopy
and write, ‘‘CT colonography appeals to
a niche of patients who are willing to
undergo bowel preparation and are
concerned about the risks of
colonoscopy.’’ In terms of risks and
tradeoffs, the MSTF describe the
requirement for bowel preparation,
extracolonic findings, inferior
sensitivity compared to other screening
tests and radiation exposure. The MSTF
writes, ‘‘[e]vidence that CT
colonography reduces CRC incidence or
mortality is lacking.’’
We also consider the online resource
RadiologyInfo,646 which is an online
public information resource developed
by health care professionals in
collaboration with patients.
RadiologyInfo is sponsored by the
645 Am J Gastroenterol 2017; 112:1016–1030; doi:
10.1038/ajg.2017.174; published online 6 June
2017.
646 RadiologyInfo website: https://
www.radiologyinfo.org/.
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Radiological Society of North America
(RSNA) and the American College of
Radiology (ACR). In terms of benefits of
CTC, RadiologyInfo described CTC as
less invasive than a Colonoscopy,
though for CTC a small tube is inserted
into the rectum to allow for inflation
with carbon dioxide or air. In addition,
CTC does not require sedation (and
transportation accommodations) and
carries less risk of bowel perforation
compared to Colonoscopy. In addition,
CTC can identify precancerous polyps
that may not be detected by stool-based
and blood-based tests. CTC may be a
less burdensome first option for patients
who are medically fragile or have
complex or unusual anatomy. In terms
of risks and tradeoffs, RadiologyInfo
describes a very small risk of perforated
bowel (during inflation), a small risk of
secondary cancer due to radiation
exposure and it being not recommended
for individuals who are pregnant.
RadiologyInfo reports that CTC applies
a patient radiation exposure similar to
Barium Enema at 6 millisieverts (mSv),
which is greater than other preventive
screenings, such as CT Lung Cancer
Screening at 1.5mSv and screening
digital mammography at 0.21 mSv.647
After considering the above
recommendations and guidelines from
appropriate organizations, we believe
CTC to be reasonable and necessary as
CRC screening test, especially for
patients and clinicians who seek a
direct visualization procedure as a first
step in CRC screening that is less
invasive and less burdensome on the
patient and healthcare system compared
to Screening Colonoscopy. Our goal is
that the patient and their clinician make
the most appropriate choice in CRC
screening, which includes
considerations of the risks, burdens and
tradeoffs for each covered test or
procedure. We expect that clinicians
who order CTC for CRC Screening will
educate their patients on risks and
context of radiation exposure and
potential extracolonic findings. A
shared decision-making tool is not
mandated but may be helpful for
clinicians and patients to weigh their
options for CRC screening.
We propose to add CTC as a covered
CRC screening test at § 410.37. We
propose to describe in regulatory text
that CTC means a test that uses X-rays
and computers to produce images of the
entire colon (including image
processing and a physician’s
interpretation of the results of the
procedure). We also propose to codify in
regulatory text that Medicare Part B
647 https://www.radiologyinfo.org/en/info/safety-
xray.
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pays for a screening computed
tomography colonography if it is
ordered in writing by the beneficiary’s
attending physician, physician assistant,
nurse practitioner, or clinical nurse
specialist. We also propose the
following limitations of coverage for
CTC:
• In the case of an individual age 45
or over who is not at high risk of
colorectal cancer, payment may be made
for a screening computed tomography
colonography performed after at least 59
months have passed following the
month in which the last screening
computed tomography colonography or
47 months have passed following the
month in which the last screening
flexible sigmoidoscopy or screening
colonoscopy was performed.
• In the case of an individual who is
at high risk for colorectal cancer,
payment may be made for a screening
computed tomography colonography
performed after at least 23 months have
passed following the month in which
the last screening computed tomography
colonography or the last screening
colonoscopy was performed.
Congress has eliminated Part B
coinsurance (section 1833(a)(1)(Y) of the
Act, § 410.152(l)(5)) and deductibles
(section 1833(b)(1) of the Act) for
covered prevention services
recommended with a grade of A or B by
the USPSTF. As described earlier in our
proposal, the USPSTF included CTC as
a screening method in their May 2021
revised Final Recommendation
Statement on CRC screening (Grade A).
Thus, if our proposal is finalized, CTC
will require no Part B coinsurance nor
deductible when furnished as a CRC
screening procedure. We clarify that
CTC will continue to require Part B
coinsurance and deductible when
furnished as a diagnostic or other nonpreventive/screening procedure.
We look forward to further
consultation with the public and
appropriate organizations through the
public comment period of this proposed
rule. We invite public comment on this
proposal.
We also propose to exercise our
authority in section 1861(pp)(1)(D) of
the Act to expand our approach to a
‘‘complete CRC screening’’ finalized in
§ 410.37(k). We propose to add a
Medicare covered Blood-based
Biomarker CRC screening test (described
and authorized in NCD 210.3) alongside
the Medicare covered non-invasive
stool-based CRC screening test within
our approach of a ‘‘complete CRC
screening.’’
Our goal is for the patient and their
healthcare professional to make the
most appropriate choice in CRC
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screening, which include considerations
of the risks, burdens and barriers
presented with an invasive screening
colonoscopy in a clinical setting as their
first step. CRC screening presents a
unique scenario where there are
significant differences between
screening stool-based tests and direct
visualization procedures such as
colonoscopy, flexible sigmoidoscopy
and CTC tests in terms of invasiveness
and burdens to the patient and
healthcare system. We recognize there
are several advantages to choosing a
non-invasive CRC screening test as a
first step compared to a screening
colonoscopy, including relative ease of
administering the test and potentially
reducing the experience of burdensome
preparation and invasive procedures.
Since the CY 2023 PFS final rule we
have heard from many interested
parties, including a number of
professional societies, that Medicare
covered blood-based biomarker tests
would be appropriately placed
alongside covered non-invasive stoolbased tests within a complete colorectal
cancer screening context. We have
reconsidered our position that Medicare
covered blood-based biomarker tests
would not belong alongside covered
non-invasive stool-based tests within
our approach to a complete CRC
screening. We consider that some
patients may consider a blood test less
uncomfortable than administering a
stool-based test, especially if the blood
draw is concurrent to a routine blood
draw for other covered routine
bloodwork. We have also heard that
some patients may prefer a non-invasive
test as their first step but view the stool
sample collection process for stoolbased tests as a meaningful barrier.648
We also consider that a blood test may
be more accessible to many patients in
rural and underserved communities
than facilities that furnish screening
colonoscopies, flexible sigmoidoscopies
and CTC.
NCD 210.3 requires that Blood-based
Biomarker Tests for CRC screening must
have Food and Drug Administration
(FDA) market authorization with an
indication for colorectal cancer
screening; and proven test performance
characteristics for a blood-based
screening test with both sensitivity
greater than or equal to 74 percent and
specificity greater than or equal to 90
percent in the detection of colorectal
cancer compared to the recognized
standard (accepted as colonoscopy at
this time), as minimal threshold levels,
648 Kolata, Gina. ‘‘A Blood Test Shows Promise
for Early Colan Cancer Detection’’ The New York
Times, March 13, 2024.
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based on the pivotal studies included in
the FDA labeling. We have heard from
interested parties that Blood-based
Biomarker tests for CRC screening may
achieve the coverage requirements
described in NCD 210.3 within the near
term and thereafter quickly become
adopted as a non-invasive option within
the healthcare system and patient
community. Given our existing coverage
policy for Blood-based Biomarker Tests
for CRC Screening (NCD 210.3), we
believe our proposal is appropriately
proactive, provides for consistent
regulatory treatment between blood and
stool-based tests, and will ready our
regulatory policies for the quickly
evolving state of medical technology in
methods for CRC screening. We note
that while blood-based biomarker tests
were not included as a screening
method within the May 2021 USPSTF
revised Final Recommendation
Statement on CRC Screening, they do
not require beneficiary cost sharing
(coinsurance and deductible) because
blood-based biomarker tests will be paid
under the Clinical Laboratory Fee
Schedule (CLFS). For additional
information, see the CMS website at
https://www.cms.gov/medicare/
payment/fee-schedules/clinicallaboratory-fee-schedule-clfs.
We propose to revise the regulatory
text describing a complete CRC
screening at § 410.37(k) to state that
colorectal cancer screening tests include
a follow-on screening colonoscopy after
a Medicare covered non-invasive stoolbased colorectal cancer screening test or
a Medicare covered blood-based
biomarker CRC screening test returns a
positive result. We also propose to
revise the regulatory text at § 410.37(k)
to state the instance of the follow-on
colonoscopy in the context of a
complete colorectal cancer screening
shall not apply to the frequency
limitations for colorectal cancer
screenings. We believe this statement in
regulatory text is clearer and recognizes,
outside the context of a complete
colorectal cancer screening, the instance
of a screening colonoscopy is factored
into the calculation of frequency
limitations of other covered CRC
screening tests and procedures in
addition to a subsequent screening
colonoscopy.
We look forward to further
consultation with the public and
appropriate organizations through the
public comment period of this proposed
rule. We invite public comment on this
proposal.
6. Summary
In summary, we are proposing to
exercise our authority at section
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1861(pp)(1)(D) of the Act update and
expand coverage for CRC screening by
(1) removing coverage for the barium
enema procedure for CRC screening; (2)
adding coverage of the CTC procedure
for CRC screening; and (3) expanding
our approach to a ‘‘Complete CRC
Screening’’ to include a covered bloodbased biomarker test alongside a
covered non-invasive stool-based test.
Our proposal to update and expand
CRC screening aligns with the
administration’s strategic pillar to
advance health equity by addressing the
health disparities that underlie our
health system. In addition, our proposal
supports Executive Order 13985 by
advancing racial equity and support for
underserved communities in the
Medicare program. We believe our
proposal will directly advance health
equity by promoting access and
removing barriers for much needed
cancer prevention and early detection
within rural communities and
communities of color that are especially
impacted by the incidence of CRC. Our
proposal to expand colorectal cancer
screening directly supports the
Administration’s Cancer Moonshot Goal
of reducing the deadly impact of cancer
and improving patient experiences in
the diagnosis, treatment, and survival of
cancer.649
Our proposal is also supportive of the
Administration’s Proclamation of March
as National Colorectal Cancer
Awareness Month in 2024, which
includes the statement, ‘‘As a country,
we have made impressive progress in
the struggle to end cancer over the past
several decades due to advancements in
prevention, early-detection measures,
and new medicines and therapies.
Despite remarkable breakthroughs,
every year, more Americans are
diagnosed with cancer under the age of
50. Earlier detection and improved
treatment of colorectal cancer continue
to be critical goals of medical research.
Further progress is also needed to
improve outcomes for those who are
disproportionately impacted by this
disease—including Americans over the
age of 45, Native Americans, Black
Americans, and people with a family
history of colorectal cancer. There is
still more work to be done to ensure
more Americans can prevent, detect,
treat, and survive colorectal cancer.’’ 650
649 https://www.whitehouse.gov/cancermoonshot/.
650 https://www.whitehouse.gov/briefing-room/
presidential-actions/2024/02/29/proclamation-onnational-colorectal-cancer-awareness-month-2024/.
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L. Requirements 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
Section 2003 of the Substance UseDisorder Prevention that Promotes
Opioid Recovery and Treatment for
Patients and Communities (SUPPORT)
Act (Pub. L. 115–271, October 24, 2018)
generally mandates that the prescribing
of a Schedule II, III, IV, or V controlled
substance under Medicare Part D be
done electronically in accordance with
an electronic prescription drug program
beginning January 1, 2021, subject to
any exceptions, which HHS may
specify. In the CY 2021, CY 2022, CY
2023, and CY 2024 PFS final rules, we
finalized policies for the CMS Electronic
Prescribing for Controlled Substances
(EPCS) Program requirements specified
in section 2003 of the SUPPORT Act.
We refer readers to 85 FR 84802 through
84807, 86 FR 65361 through 65370, 87
FR 70008 through 70014, and 88 FR
79285 through 79292 for the details of
those finalized policies. Specifically, in
the CY 2021 PFS final rule, we
established a requirement that all
prescribers conduct electronic
prescribing of Schedule II, III, IV, and V
controlled substances covered under the
Medicare prescription drug program,
subject to any exceptions, which HHS
may specify, using the NCPDP SCRIPT
standard version 2017071 with an
effective date of January 1, 2021, and a
compliance date of January 1, 2022 (85
FR 84807). In the CY 2022 PFS final
rule, we finalized a policy to require
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); and finalized multiple proposals
related to the classes of exceptions
specified by section 2003 of the
SUPPORT Act (86 FR 65366 through
65369). We also extended the earliest
date of compliance actions to no earlier
than January 1, 2023 (86 FR 65364). For
prescribers who do not meet the
compliance threshold based on
prescriptions written for a beneficiary in
a long-term care (LTC) facility, we
extended the earliest date of compliance
actions to no earlier than January 1,
2025 (86 FR 65364 and 65365). We also
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
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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, 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).
In the CY 2024 PFS final rule (88 FR
79285 through 79287), we identified
certain terms that we will use in the
CMS EPCS Program and clarified that,
by virtue of the cross reference in
§ 423.160(a)(5) to ‘‘the applicable
standards in paragraph (b) of this
section,’’ which refers to the standards
in § 423.160(b), the CMS EPCS Program
will automatically adopt the electronic
prescribing standards at § 423.160(b) as
they are updated. Additionally, we
finalized our proposals to remove the
same entity exception 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) (88 FR
79287 through 79288). As a result,
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), and prescribers are not
exempt from the requirement to
prescribe electronically at least 70
percent of their Schedule II through V
controlled substances that are Part D
drugs—but such prescriptions have to
meet the applicable standards in
§ 423.160(b) subject to the exemption in
§ 423.160(a)(3)(iii). We also finalized a
policy to count only the unique
prescriptions in the measurement year
for the purposes of CMS EPCS Program
compliance threshold calculations (88
FR 79288). Furthermore, for the
exceptions that we moved to
§ 423.160(a)(5)(ii) and (iii), we modified
the exceptions to permit prescribers to
apply for waivers in times of an
emergency and disaster and to limit the
emergencies or disasters that will trigger
the recognized emergency exception.
We also modified the duration of both
exceptions and established timing
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requirements for submitting a waiver
application (88 FR 79288 through
79291). Lastly, we stated that we will
send notices of non-compliance for each
measurement year a prescriber is noncompliant and will provide educational
opportunities to support prescribers in
becoming compliant (88 FR 79291
through 79292).
2. Timeline for Including Prescriptions
Written for Beneficiaries in Long-Term
Care (LTC) Facilities in CMS EPCS
Program Compliance Calculation
a. Background
In the CY 2021 PFS final rule (85 FR
84807), we adopted the requirement for
all Schedule II, III, IV, and V controlled
substances for covered Part D drugs
prescribed electronically to be
prescribed using the applicable
standards in § 423.160(b), including the
NCPDP SCRIPT standard version
2017071. In the CY 2022 PFS final rule
(86 FR 65364), we finalized a policy to
extend the date on or after which we
will pursue compliance actions against
prescribers based on Part D controlled
substance prescriptions those
prescribers write for beneficiaries in
long-term care (LTC) facilities to January
1, 2025. We acknowledged that
prescribers who work in LTC facilities
or who provide care to residents in LTC
facilities faced technological barriers
that other prescribers did not face. One
such barrier was that the NCPDP
SCRIPT standard version 2017071
lacked appropriate guidance for EPCS in
LTC facilities. We also noted that
NCPDP was in the process of creating a
new version of the SCRIPT standard that
would be better suited for use by
prescribers serving LTC facilities, which
would allow willing partners to enable
three-way communication between the
prescriber, LTC facility, and pharmacy
to bridge any outstanding gaps that
impede use of the NCPDP SCRIPT
standard version 2017071 for EPCS in
the LTC setting (86 FR 65364).
We received public comments on the
CY 2022 PFS proposed rule requesting
that we exempt prescribers writing Part
D controlled substance prescriptions for
beneficiaries in LTC facilities from
having to conduct EPCS until after
NCPDP SCRIPT standard version
2022011 was adopted. In response to
those comments, in the CY 2022 PFS
final rule, we noted that our intent
when extending the date on or after
which we will pursue compliance
actions against prescribers based on Part
D controlled substance prescriptions
those prescribers write for beneficiaries
in LTC facilities was to strike a balance
between being responsive to stakeholder
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concerns surrounding the increased
implementation barriers faced by LTC
facilities, while at the same time helping
to ensure that these facilities eventually
implement, and receive the benefits of
EPCS (86 FR 65364). Furthermore, we
noted that we were not persuaded to
further delay commencing compliance
actions to await publication of the
NCPDP SCRIPT standard version
2022011. We acknowledged that threeway communication is not as seamless
in the NCPDP SCRIPT standard version
2017071 as it may be in upcoming
versions. We also stated that three-way
communication is still possible with
some modifications to EPCS, and
therefore, we did not believe it would be
appropriate to adopt a further delay on
this basis alone (86 FR 65364).
In the 2024 PFS final rule (88 FR
79286 through 79287), we clarified 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. We noted that in 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 (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 NCPDP
SCRIPT standard version 2017071 by
January 1, 2025.
Although we did not propose any
policy changes regarding the NCPDP
SCRIPT standard version in the CY 2024
PFS proposed rule (88 FR 52532), we
received public comments requesting
clarification on when the new NCPDP
SCRIPT standard version would be
adopted and the implications for
measuring EPCS compliance in LTC. In
response to those comments, in the CY
2024 PFS final rule (88 FR 79286), we
acknowledged that we had not finalized
our proposal regarding the NCPDP
SCRIPT standard version 2022011 that
was proposed in the CY 2024 Medicare
Advantage and Part D Policy and
Technical Changes proposed rule. We
also acknowledged that some
prescribers prescribing for beneficiaries
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in LTC facilities have adopted EPCS, but
that others have waited for the standard
to be updated (88 FR 79286 through
79287). We noted that if the requirement
to use an updated version of the NCPDP
SCRIPT standard is finalized for a date
after January 1, 2025, we may explore
whether a waiver is appropriate for
prescribers who are not compliant
solely as a result of prescriptions they
have written for beneficiaries in LTC
facilities or we may revisit the
compliance start date, if needed,
through future rulemaking (88 FR
79287).
In the ‘‘Medicare Program; Medicare
Prescription Drug Benefit Program;
Health Information Technology
Standards and Implementation
Specifications’’ final rule (89 FR 51242
through 51247), which appeared in the
June 17, 2024 Federal Register
(hereinafter referred to as the June 2024
Part D and Health IT Standards final
rule), we finalized at § 423.160(b)(1) the
requirement that Part D sponsors,
prescribers and dispensers, when
electronically transmitting prescriptions
and prescription-related information for
covered Part D drugs for Part D eligible
individuals, must comply with a
standard in 45 CFR 170.205(b). Taken in
conjunction with the standards and
expiration date adopted by the Office of
the National Coordinator for Health
Information Technology (ONC), as
described in the June 2024 Part D and
Health IT Standards final rule (89 FR
51258 through 51259), § 423.160(b)(1)
will require use of NCPDP SCRIPT
standard version 2023011, which ONC
is adopting at 45 CFR 170.205(b)(2),
beginning January 1, 2028, and retire
use of NCPDP SCRIPT standard version
2017071, which ONC previously
adopted at 45 CFR 170.205(b)(1) and to
which it is applying an expiration date
of January 1, 2028. ONC finalized
January 1, 2028, as the expiration date
for NCPDP SCRIPT standard version
2017071 instead of January 1, 2027, in
consideration of public comments
requesting that the date be delayed. As
a result of these policies being finalized,
the NCPDP SCRIPT standard version
2023011 will be required for the CMS
EPCS Program by January 1, 2028. As
both NCPDP SCRIPT standard version
2017071 and NCPDP SCRIPT standard
version 2023011 will be adopted at 45
CFR 170.205(b) and unexpired as of the
effective date of the June 2024 Part D
and Health IT Standards final rule,
entities subject to the requirement at
§ 423.160(b)(1) may use either version of
the NCPDP SCRIPT standard during the
transition period beginning July 17,
2024, the effective date of the June 2024
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Part D and Health IT Standards final
rule, and ending December 31, 2027,
which is the last day before NCPDP
SCRIPT standard version 2017071 will
expire for the purposes of HHS use.
b. Barriers to Electronic Prescribing of
Controlled Substances for Beneficiaries
in LTC and the Role of Three-Way
Communication in the NCPDP SCRIPT
Standard
We understand the challenges of
conducting EPCS in the LTC setting to
be multifactorial. The specific
challenges include prescribers being
responsible for covering multiple LTC
facilities, each with different electronic
health record (EHR) systems; reliance on
LTC nursing staff to communicate
prescriptions to the pharmacy on behalf
of the prescriber; and with respect to
NCPDP SCRIPT standard version
2017071, lack of three-way (or multiparty) communication between the
prescriber, the LTC facility, and the
pharmacy.
When conducting EPCS using the
NCPDP SCRIPT standard version
2017071, prescribers can submit
prescriptions electronically to the
pharmacy, but the prescriber must
subsequently contact the LTC facility
separately to give an order for the
medication so the LTC facility can
administer the medication to the patient
as prescribed. In cases where EPCS is
being conducted and the prescriber has
not communicated a separate order to
the LTC facility, the pharmacy may
deliver a prescription to the LTC facility
and the facility staff has no record of the
order. Then the LTC facility staff must
contact the prescriber for an order to be
able to administer the drug to the
patient.
To conduct EPCS without having to
separately communicate an order to the
LTC facility, prescribers can use a web
portal to enter an order in the LTC
facility’s EHR and then, if the EHR
supports the necessary EPCS
capability,651 the prescription can be
transferred to the pharmacy. However,
not all LTC facilities have EHRs with
this functionality. Additionally, each
LTC facility may have its own web
portal, making the number of portals
and credentials overly burdensome for
prescribers who treat patients who
651 According to the Drug Enforcement
Administration (DEA), for an electronic prescribing
system to be used to transmit controlled substance
prescriptions, a third party must audit the
electronic prescribing application for compliance
with the requirements of 21 CFR part 1311, or a
certifying organization whose certification process
has been approved by DEA must verify and certify
that the application meets the requirements of 21
CFR part 1311. See https://www.deadiversion
.usdoj.gov/ecomm/thirdparty.html.
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reside in multiple different LTC
facilities. After providing an order to the
LTC facility, prescribers often rely on
LTC facility nursing staff to relay verbal
prescription orders to pharmacies as
permitted under 21 CFR 1306.03(b) and
1306.21(a).
NCPDP SCRIPT standard version
2023011 permits three-way
communication that would better
facilitate LTC workflows in a way that
NCPDP SCRIPT standard version
2017071 does not. In comments NCPDP
submitted in response to the CY 2025
Medicare Advantage and Part D Policy
and Technical Changes proposed rule,
NCPDP confirmed that it attempted to
create guidance on three-way
communication using the NCPDP
SCRIPT standard version 2017071, but it
was not realistic in that version of the
standard.652 In NCPDP SCRIPT standard
version 2023011, through use of a
MessageIndicatorFlag, an RxFill
transaction may be sent as a copy to
inform or synchronize systems.653
Through use of this functionality, a
prescriber can electronically send a
controlled substance prescription
(including for a covered Part D drug) to
a pharmacy, and the pharmacy can use
the MessageIndicatorFlag in an RxFill
transaction when dispensing the
prescription to inform the LTC facility
of the medication order. This
functionality streamlines prescribers’
workflows and ensures that the LTC
facility responsible for providing the
controlled substance to the patient is
aware of the order.
lotter on DSK11XQN23PROD with PROPOSALS2
c. Timeframe for Including Prescriptions
Written for Beneficiaries in LTC in the
CMS EPCS Program Compliance
Calculation
We received multiple public
comments in response to the proposal in
section III.B.4. of the CY 2025 Medicare
Advantage and Part D Policy and
Technical Changes proposed rule (88 FR
78489) to require NCPDP SCRIPT
standard version 2023011 and retire
NCPDP SCRIPT standard version
2017071, requesting that we reconsider
the current January 1, 2025, compliance
date for when we will include
prescriptions written for covered Part D
drugs for Part D eligible individuals in
652 https://standards.ncpdp.org/Standards/
media/pdf/Correspondence/2024/NCPDP-Letter-toCMS-regarding-CMS-4205-P.pdf.
653 National Council for Prescription Drug
Programs (NCPDP) SCRIPT Standard,
Implementation Guide, Version 2023011. Approval
Date for American National Standards Institute
(ANSI): January 17, 2023, April 2023. NCPDP
SCRIPT standard implementation guides are
available to NCPDP members for free and to nonmembers for a fee at https://standards.ncpdp.org/
Access-to-Standards.aspx.
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a LTC facility in the CMS EPCS Program
compliance calculation. Commenters
requested that we align the CMS EPCS
Program compliance date for
prescriptions written for beneficiaries in
LTC with the date that NCPDP SCRIPT
standard 2023011 will be required. In
the June 2024 Part D and Health IT
Standards final rule, we indicated that
we would consider a change to the CMS
EPCS Program compliance date for LTC
through the annual Medicare Physician
Fee Schedule rulemaking process (89 FR
51247).
In this proposed rule, we are
proposing to revise § 423.160(a)(5) to
state that prescriptions written for a
beneficiary in a LTC facility would not
be included in determining compliance
until January 1, 2028, and that
compliance actions against prescribers
who do not meet the compliance
threshold based on prescriptions written
for a beneficiary in a LTC facility would
commence on or after January 1, 2028.
We do not otherwise propose to revise
the text of § 423.160(a)(5).
As of the effective date of the June
2024 Part D and Health IT Standards
final rule, July 17, 2024, Part D
sponsors, prescribers and dispensers,
when electronically transmitting
prescriptions and prescription-related
information for covered Part D drugs for
Part D eligible individuals, may use
NCPDP SCRIPT standard version
2023011. However, as discussed, there
will be a transition period where both
NCPDP SCRIPT standard version
2023011 and NCPDP SCRIPT standard
version 2017071 can be used. ONC
finalized an expiration date for NCPDP
SCRIPT standard version 2017071 of
January 1, 2028 (rather than January 1,
2027, as proposed), in part due to
commenters’ concern about
implementing the new standard in LTC
facilities (89 FR 51247).
We recognize the administrative
burden prescribers could potentially
face when implementing EPCS for
prescriptions written for covered Part D
drugs for Part D eligible individuals in
LTC facilities using NCPDP SCRIPT
standard version 2017071, particularly
with the lack of guidance. We also
believe that even though prescribers can
use NCPDP SCRIPT standard version
2023011 as of July 17, 2024, it may not
be feasible to have electronic
prescribing systems configured to
NCPDP SCRIPT standard version
2023011 by January 1, 2025, the current
date by which prescriptions written for
covered Part D drugs for Part D eligible
individuals in LTC facilities would be
included in the CMS EPCS Program
compliance threshold calculation. By
delaying the inclusion of prescriptions
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61999
written for covered Part D drugs for Part
D eligible individuals in LTC facilities
in the CMS EPCS Program compliance
threshold calculation to January 1, 2028,
we would be aligning CMS EPCS
Program compliance calculations to the
date by which the NCPDP SCRIPT
standard version 2017071 is retired and
the new NCPDP SCRIPT standard
version 2023011 is required for
prescribers when electronically
transmitting prescriptions and
prescription-related information for
covered Part D drugs for Part D eligible
individuals. We believe doing so would
provide sufficient time for prescribers
and pharmacies to adopt the new
standard. Moreover, LTC facilities will
need to configure their EHR systems to
be able to receive the
MessageIndicatorFlag from the
pharmacy, indicating that the
prescription has been filled, and
establish the necessary policies or
operations to convert such a message
into an order for the patient in the LTC
facility.
We considered an alternative where
we would permit prescribers to apply
for a waiver for circumstances beyond
their control rather than modify the date
to include prescriptions for beneficiaries
in LTC in the compliance threshold
calculation. In 2022, approximately 4.7
percent (4.5 million) of Part D Schedule
II, III, IV, and V controlled substance
prescriptions were written for
beneficiaries in LTC facilities, with
roughly 52 percent (2.4 million) of them
not meeting the CMS EPCS Program
standards for e-prescribing. If we kept
the existing start date of January 1, 2025,
as in the current regulatory text at
§ 423.160(a)(5) for the CMS EPCS
Program, we estimate at least 6,800
additional prescribers would become
non-compliant. These estimates are
prior to considering emergency and
disaster exceptions and waivers, which
could reduce these numbers. If we do
not extend the current date by which
prescriptions written for covered Part D
drugs for Part D eligible individuals in
LTC facilities would be included in the
CMS EPCS Program compliance
threshold calculation, then starting with
the CY 2025 measurement year,
thousands of prescribers may become
non-compliant, and those prescribers
would potentially apply for a waiver.
We would expect that by the CY 2028
measurement year, many of these
prescribers would be compliant and
would not need to apply for a waiver
because beginning January 1, 2028,
NCPDP SCRIPT standard version
2023011 will be the required standard
for prescribing and dispensing Part D
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Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
drugs to Part D eligible individuals and
commenters have indicated that this
version of the standard will facilitate
EPCS in LTC. We remind prescribers
that the CMS EPCS Program compliance
rate is calculated using the Prescription
Origin Code data element in the PDE
record (88 FR 79287), and the PDE is a
record of the prescription dispensing
event.654 We believe that the three-way
communication in the NCPDP SCRIPT
standard version 2023011 improves
communication of the controlled
substance prescription as a medication
order to the LTC facility’s EHR when the
pharmacy fills the prescription, but we
seek comment on how the NCPDP
SCRIPT standard version 2023011 will
improve prescribers’ ability to conduct
EPCS to the pharmacy dispensing the
prescription for individuals in LTC
facilities.
Should we finalize our proposal, we
encourage prescribers who write
Schedule II, III, IV, or V controlled
substance prescriptions for covered Part
D drugs for Part D eligible individuals
in LTC facilities to use the additional
time to prepare for when such
prescriptions for beneficiaries in LTC
facilities would be included in the CMS
EPCS Program compliance threshold
calculation by working to adopt the new
standard or investing in technology
necessary to conduct EPCS.
We seek comment on our proposals to
extend the date after which
prescriptions for covered Part D drugs
for Part D eligible individuals in LTC
facilities would be included in our CMS
EPCS Program compliance threshold
calculation from January 1, 2025, to
January 1, 2028, and that related noncompliance actions would commence
on or after January 1, 2028. We
additionally seek comment on how
NCPDP SCRIPT standard version
2023011 is expected to improve
prescribers’ ability to conduct EPCS to
pharmacies dispensing covered Part D
drugs to Part D eligible individuals in
LTC facilities.
lotter on DSK11XQN23PROD with PROPOSALS2
654 CMS Memorandum. ‘‘Updated Instructions:
Requirements for Submitting Prescription Drug
Event Data (PDE).’’ April 27, 2006. Available from:
https://www.csscoperations.com/internet/csscw3_
files.nsf/F/CSSCPDEGuidance.pdf/$FILE/
PDEGuidance.pdf.
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M. Expand Hepatitis B Vaccine
Coverage
Hepatitis B vaccines are currently
covered as a Medicare Part B benefit
under section 1861(s)(10)(B) of the Act.
Medicare beneficiaries who are at high
or intermediate risk of contracting
hepatitis B can receive hepatitis B
vaccines, with no cost to the
beneficiary. The statute expressly
authorizes the Secretary to determine
who is at high or intermediate risk of
contracting hepatitis B by issuing
regulations. The Secretary, through past
rulemaking, defined high and
intermediate risk groups for hepatitis B
vaccine at 42 CFR 410.63. This
definition was last updated in the CY
2013 PFS final rule (77 FR 69363).
Beneficiaries with coverage under
Medicare Part D whose level of risk falls
outside high or intermediate may have
their vaccine covered under the Part D
benefit.655
Medicare coverage of hepatitis B
vaccination is outdated in light of more
recent information about the risks of
contracting hepatitis B. As explained in
more detail in this section, we are
proposing to improve access and
utilization of hepatitis B vaccines by
expanding the list of individuals who
are at high or intermediate risk of
contracting hepatitis B in § 410.63(a).
1. Background
Hepatitis B is a vaccine-preventable
liver disease caused by the hepatitis B
virus.656 The vaccine consists of a series
of typically 2–3 doses depending on the
formulation delivered at various
intervals.657 Hepatitis B virus is
transmitted when body fluid (blood,
semen, or other) from a person infected
655 Sayed, BA, Finegold, K, Ashok, K, Schutz, S,
De Lew, N, Sheingold, S, Sommers, BD. Inflation
Reduction Act Research Series: Medicare Part D
Enrollee Savings from Elimination of Vaccine CostSharing. (Issue Brief No. HP–2023–05). Office of the
Assistant Secretary for Planning and Evaluation,
U.S. Department of Health and Human Services.
September 2023. Retrieved from https://
aspe.hhs.gov/sites/default/files/documents/
407d41b6534e7af6702eb280b3945d00/aspe-iravaccine-part-d.pdf.
656 CDC, 2023. Hepatitis B surveillance 2021.
Retrieved from https://www.cdc.gov/hepatitis/
statistics/2021surveillance/hepatitis-b.htm.
657 CDC. Viral hepatitis. FAQ for health
professionals. Atlanta, GA: U.S. HHS, CDC; 2022.
Retrieved from https://www.cdc.gov/hepatitis/hbv/
hbvfaq.htm.
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with the virus enters the body of
someone who is uninfected.658 This can
happen through sexual contact; sharing
needles, syringes, or other druginjection equipment; transmission from
the gestational parent to baby during
pregnancy or at birth; direct contact
with blood or open sores; or sharing
contaminated items such as
toothbrushes, razors or medical
equipment (such as a glucose monitor)
of a person who has hepatitis B.659
Hepatitis B can be an acute, short-term
illness and it can develop into a longterm, chronic infection. Chronic
hepatitis B can lead to serious health
problems, including cirrhosis, liver
cancer, and death. Treatments for
hepatitis B are available but no cure
exists. There are currently an estimated
2.4 million individuals in the U.S.
living with hepatitis B virus and an
estimated 20,000 new infections every
year.660 Acute hepatitis B infections
among adults leads to chronic hepatitis
B disease in an estimated 2–6 percent of
cases.661 Rates of reported cases of acute
hepatitis B have steadily increased
among persons aged 40–49, 50–59 years,
and 60 years and older from 2015–
2019.662 In 2020, rates declined in all
adult age groups. In 2021, rates among
all age groups remain stable or declined
compared to 2020. The highest rates
were among persons 40–49 years (1.6
cases per 100,000 population) and 50–
59 years (1.0 case per 100,000
population). The rates for people aged
60 years and older were 0.5 cases per
100,000 population.
658 CDC, 2023. Hepatitis B surveillance 2021.
Retrieved from https://www.cdc.gov/hepatitis/
statistics/2021surveillance/hepatitis-b.htm.
659 CDC. 2024. Viral Hepatitis FAQs for the
public. Retrieved from https://www.cdc.gov/
hepatitis/hbv/bfaq.htm.
660 Conners EE, Panagiotakopoulos L, Hofmeister
MG, et al. Screening and testing for hepatitis B virus
infection: CDC recommendations—United States,
2023. MMWR Recomm Rep. 2023;72(1):1–25.
Retrieved from https://www.cdc.gov/mmwr/
volumes/72/rr/rr7201a1.htm.
661 Weng, M., Doshani, M., Khan, M., Frey, S., et
al. Universal hepatitis B vaccination in adults aged
19–59 years: Updated recommendations of the
Advisory Committee on Immunization Practices—
United States, 2022. MMWR, April 1, 2022, Vol
71(13);477–483.
662 CDC. Viral hepatitis. 2021 viral hepatitis
surveillance report. Atlanta, GA: U.S. HHS, CDC;
2023. Retrieved from https://www.cdc.gov/
hepatitis/statistics/2021surveillance/hepatitis-b/
figure-2.4.htm.
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Hepatitis B vaccines are safe and
effective in preventing hepatitis B
virus.663 The number of reported
hepatitis B cases has declined
substantially since the vaccine was
introduced in 1982, which was achieved
through incremental expansion of
groups for whom the vaccine was
recommended. However, vaccination
coverage among adults has been
deficient and further reduction in
hepatitis B infections in the U.S. has
stalled. Approximately 34 percent of
adults aged ≥19 years have been
vaccinated against hepatitis B.664
Furthermore, an estimated 20 percent of
adults aged ≥60 years have been
vaccinated against hepatitis B.
Since 2011, rates of reported cases of
acute hepatitis B decreased among
children and adolescents aged 0–19
years and persons aged 20–29 years.665
The Centers for Disease Control and
Prevention (CDC) states that this is due,
in part, because of the childhood
hepatitis B vaccine recommendations
that were first implemented in 1991.
The Advisory Group for Immunization
Practices (ACIP) is a group of medical
and public health experts that develops
recommendations on how to use
vaccines to control diseases in the U.S.
and the CDC updates the U.S. adult and
childhood immunization schedules
consistent with ACIP
recommendations.666 As the cohort of
persons vaccinated as children have
62001
grown older, rates of acute hepatitis B
among persons aged 30–39 years began
to consistently decrease beginning in
2015.667 Conversely, rates of reported
cases of acute hepatitis B have steadily
increased among persons aged 40–49,
50–59 years, and 60 years and older
from 2015–2019 (see Table 52). Overall,
the rate of acute hepatitis B cases
increased 11 percent from 2014 (0.9 per
100,000) to 2018 (1.0 per 100,000).668
Injection drug use and sexual
transmission are known risk factors
associated with rising acute hepatitis B
cases. For example, acute hepatitis B
infections increased 114 percent from
2006 to 2013 in three states affected by
the opioid epidemic (Kentucky,
Tennessee, and West Virginia).669
TABLE 52: Rates of Reported Acute Hepatitis B Virus Infection, by Age Group- United
States
0-19
0.0
0.0
0.0
0.0
0.0
20-29
0.8
0.6
0.6
0.6
0.5
30-39
2.6
2.4
2.3
2.0
1.8
40--49
2.4
2.2
2.5
2.6
2.7
50-59
1.4
1.5
1.6
1.6
1.6
::,.60
0.5
0.5
0.6
0.6
0.6
2. Statutory Authority
lotter on DSK11XQN23PROD with PROPOSALS2
Section 1861(s)(10)(B) of the Act
provides a benefit category under Part B
for hepatitis B vaccine and its
administration, furnished to an
individual who is at high or
intermediate risk of contracting
hepatitis. The statute expressly
authorizes the Secretary to determine
who is at high or intermediate risk of
663 Weng, M., et al. 2022. Universal hepatitis B
vaccination.
664 CDC. 2023. Vaccination Coverage among
Adults in the United States, National Health
Interview Survey, 2021. Retrieved from https://
www.cdc.gov/vaccines/imz-managers/coverage/
adultvaxview/pubs-resources/vaccination-coverageadults-2021.html#:∼:text=Hepatitis%20B%
20vaccination%20coverage%20in,and%20
Other%20(40.2%25)%20adults.
665 CDC. Viral hepatitis. 2021 viral hepatitis
surveillance report. Atlanta, GA: U.S. HHS, CDC;
2023. Retrieved from https://www.cdc.gov/
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Medicare Part B pays for the hepatitis
B vaccine as defined in § 410.63(a),
which describes individuals who are at
high or intermediate risk of contracting
hepatitis and covered for hepatitis B
vaccinations. In the CY 2013 PFS final
rule (77 FR 69363), CMS expanded the
definition of individuals at risk of
contracting hepatitis B, citing updated
ACIP recommendations about increased
risk for diabetes patients to support the
change. The ACIP stated that the
hepatitis B outbreaks were associated
with adults with diabetes receiving
assisted blood glucose monitoring.670
Today, the regulations are outdated as
these risk categories have been shown
ineffective and are no longer the focus
of how the medical community
discusses hepatitis B infection and
hepatitis/statistics/2021surveillance/hepatitis-b/
figure-2.4.htm.
666 CDC. ACIP. Retrieved from https://
www.cdc.gov/vaccines/acip/.
667 CDC. Viral hepatitis. 2021 viral hepatitis
surveillance report. Atlanta, GA: U.S. HHS, CDC;
2023. Retrieved from https://www.cdc.gov/
hepatitis/statistics/2021surveillance/hepatitis-b/
figure-2.4.htm.
668 CDC 2020. Viral hepatitis surveillance report
2018—Hepatitis B. Retrieved from https://
www.cdc.gov/hepatitis/statistics/2018surveillance/
HepB.htm.
669 HHS. 2016. Viral Hepatitis in the United
States: Data and Trends. Retrieved from https://
www.hhs.gov/hepatitis/learn-about-viral-hepatitis/
data-and-trends/.
670 CDC. 2011. Use of Hepatitis B Vaccination for
Adults with Diabetes Mellitus: Recommendations of
the Advisory Committee on Immunization Practices
(ACIP). MMWR. 60(50);1709–1711. Retrieved from
https://www.cdc.gov/mmwr/preview/mmwrhtml/
mm6050a4.htm#:∼:text=Based%20on%20the%20
Work%20Group,made%20(recommendation
%20category%20A).
contracting hepatitis B for coverage of
the hepatitis B vaccine.
3. Regulation
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EP31JY24.084
Source: CDC, National Notifiable Diseases Surveillance System.
* Rates per 100,000 population. Beginning in 2021, single-race population estimates are used
for rate calculations. For rior ears, brid ed-race o ulation estimates are used.
t Reported confirmed•cases. For the case definition, see
htt s://ndc.services.cdc. ov/conditions/he atitis-b-acute/.
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prevention. In 2019, risk behavior and
exposure data were missing for 37
percent of case reports (1,183 of 3,192)
of acute hepatitis B infections received
by CDC.671 ACIP also cited a large
national survey of family medicine and
internal medicine physicians assessing
barriers to adult hepatitis B vaccination
and found that 68% cited patients’ nondisclosure of risk factors.672
4. Proposed Regulatory Revisions
lotter on DSK11XQN23PROD with PROPOSALS2
Since 1991, hepatitis B vaccination
has been recommended by ACIP and the
CDC for infants at birth, completing the
vaccination series by 16 months of
age.673 This is important because in the
U.S., the age cohorts who have received
the completed series have low to no risk
of contracting the hepatitis B virus, as
evidenced by the rate of zero acute
hepatitis B virus infections for the 0–19
age group.674 The infant and childhood
recommendations were not in place for
most of today’s adults which is
evidenced by no other age group
reaching a rate of zero acute hepatitis B
virus infections. Given this information,
we consider the population of people
who have completed the vaccination
series to be at low risk of contracting the
hepatitis B virus. Individuals who
remain unvaccinated against hepatitis B
are at intermediate risk, at minimum, of
contracting hepatitis B virus.
We conclude that anyone who is not
fully vaccinated to be at intermediate
risk of contracting the hepatitis B virus
as their risk would be above zero.
Additionally, rates of reported cases of
acute hepatitis B steadily increased
among age groups 40 and over between
2015 and 2019, with stabilizing or
declining rates between 2020 and 2021,
which may be due to the COVID–19
pandemic.675 While it is encouraging to
see declining rates, these populations
remain at intermediate risk given their
reported cases remained above zero.
Therefore, we propose to revise
671 Weng, M., et al. 2022. Universal hepatitis B
vaccination.
672 Daley MF, Hennessey KA, Weinbaum CM, et
al. Physician practices regarding adult hepatitis B
vaccination: a national survey. Am J Prev Med
2009;36:491–6. PMID:19362798 https://doi.org/
10.1016/j. amepre.2009.01.037.
673 CDC, 2024. Vaccine safety: Hepatitis B
vaccines. Retrieved from https://www.cdc.gov/
vaccinesafety/vaccines/hepatitis-b-vaccine.html#:∼:
text=CDC%20recommends%20
hepatitis%20B%20vaccine,not%20yet
%20gotten%20the%20vaccine.
674 CDC. Viral hepatitis. 2021 viral hepatitis
surveillance report. Atlanta, GA: U.S. HHS, CDC;
2023. Retrieved from https://www.cdc.gov/
hepatitis/statistics/2021surveillance/hepatitis-b/
figure-2.4.htm.
675 CDC, 2023. Hepatitis B surveillance 2021.
Retrieved from https://www.cdc.gov/hepatitis/
statistics/2021surveillance/hepatitis-b.htm.
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§ 410.63(a)(2), Intermediate Risk
Groups, by adding a new paragraph
(a)(iv) to include individuals who have
not previously received a completed
hepatitis B vaccination series or whose
vaccination history is unknown. We
include the latter group in this proposal
because the CDC has stated that it is not
harmful to receive either extra doses or
a repeat vaccination series.676 This will
allow these individuals to receive a
covered vaccination series when
medical history may not be available.
Also, the CDC states that screening for
hepatitis B virus is not a requirement for
vaccination, and in settings where
screening is not feasible, vaccination of
persons recommended to receive the
vaccine should continue.
We note that § 410.63(a)(3) provides
an exception to individuals considered
intermediate or high risk of contracting
hepatitis B. This includes individuals
who have undergone a prevaccination
screening and have been found to be
currently positive for antibodies to
hepatitis B. We propose that this
exception apply to the proposed
§ 410.63(a)(2)(iv) because individuals
with previous infection would not
benefit from the vaccine. However, it
should be noted that the CDC states that
it is not harmful to vaccinate people
who are immune to hepatitis B virus
because of current or previous infection
or vaccination, nor does it increase the
risk for adverse events.677
5. Summary
This proposal will help protect
Medicare beneficiaries from acquiring
hepatitis B infection, contribute to
eliminating viral hepatitis as a public
health threat in the United States and is
in the best interest of the Medicare
program and its beneficiaries. We look
forward to receiving public comment on
these proposals.
N. Low Titer O+ Whole Blood
Transfusion Therapy During Ground
Ambulance Transport
1. Ambulance Fee Schedule Background
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. Our regulations
relating to coverage for ambulance
676 CDC. Viral hepatitis. FAQ for health
professionals. Atlanta, GA: U.S. HHS, CDC; 2022.
Retrieved from https://www.cdc.gov/hepatitis/hbv/
hbvfaq.htm.
677 CDC. Viral hepatitis. FAQ for health
professionals. Atlanta, GA: U.S. HHS, CDC; 2022.
Retrieved from https://www.cdc.gov/hepatitis/hbv/
hbvfaq.htm.
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services are set forth at 42 CFR part 410,
subpart B. 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 in
§ 414.610(c)(1)(ii) and (c)(5)(ii) to the
base rate and/or mileage rate.
2. Low Titer O+ Whole Blood
Transfusion Therapy During Ground
Ambulance Transport
Under the AFS, Medicare Part B
covers seven levels of service for ground
(including water) ambulance transports
and two levels of service for air
ambulance transports. The levels of
service for ground ambulance transports
include basic life support (emergency);
basic life support (non-emergency);
advanced life support, level 1 (ALS1)
(emergency); ALS1 (non-emergency);
advanced life support, level 2 (ALS2);
paramedic intercept; and specialty care
transport (§ 410.40(c)). Definitions for
the levels of service can be found at
§ 414.605 and in the Medicare Benefit
Policy Manual, Chapter 10, Ambulance
Services, section 30.1.1, Definition of
Ground Ambulance Services.
At § 414.605, ALS2 is defined as
either transportation by ground
ambulance vehicle, medically necessary
supplies and services, and the
administration of at least three
medications by intravenous push/bolus
or by continuous infusion, excluding
crystalloid, hypotonic, isotonic, and
hypertonic solutions (Dextrose, Normal
Saline, Ringer’s Lactate); or
transportation, medically necessary
supplies and services, and the provision
of at least one of the following ALS
procedures: (1) Manual defibrillation/
cardioversion; (2) Endotracheal
intubation; (3) Central venous line; (4)
Cardiac pacing; (5) Chest
decompression; (6) Surgical airway; (7)
Intraosseous line. These procedures
must be performed by ALS personnel
trained to the level of the emergency
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medical technician-intermediate (EMTIntermediate) or paramedic (§ 414.605).
According to the 2020 National
Association of State Emergency Medical
Services Organizations Assessment
(NASEMSO), there are approximately
11,450 ground EMS agencies that
provide 9–1–1 response with transport
to an acute care hospital.678 The
administration of low titer O+ whole
blood transfusions, otherwise referred to
as whole blood transfusion therapy
(WBT), began in 2017 when two
Emergency Medical Services (EMS)
systems in Texas began providing WBT
to patients in hemorrhagic shock during
ambulance transports. Prior to this, use
of blood products in the treatment of
hemorrhagic shock in the form of blood
component therapy was available only
in the hospital setting and by one EMS
system. Low titer O+ whole blood
contains low levels of antibodies that
patients of any blood type can receive
and is provided in EMS settings to
significantly increase these patients’
chances of survival.
By September 2023, over 121 EMS
systems in the United States were using
blood products in the form of either
WBT, packed red blood cells (PRBCs),
plasma, or a combination of PRBCs and
plasma.679 Seventy percent of these
systems were using WBT.680 As of
March 2024, 147 (1.2 percent of the
EMS systems in the United States) now
carry whole blood products, with 200 or
more systems anticipated to provide
some form of blood product transfusion
by the end of 2024.681 Today, nearly 60
percent of those 147 EMS systems carry
low titer O+ whole blood, with the
remainder utilizing other blood
products.682
EMS systems that administer WBT
and other blood products (PRBCs and
plasma) generally utilize it for patients
suffering hemorrhagic shock stemming
from traumatic injury, though it may
also be indicated in certain non678 National Association of State EMS Officials.
2020 National Emergency Medical Services
Assessment 2020. Table 3, p 27. Available from:
www./https://nasemso.org/. Accessed May 1, 2024.
679 Krohmer J. Chairman, steering committee of
the Prehospital Blood Transfusion Initiative
Coalition. Virtual Meeting April 23, 2024.
680 Levy MJ, Garfinkel EM, May R, et al.
Implementation of a prehospital whole blood
program: Lessons. J Am Coll Emerg Physicians
Open. 2024;5: e13142. https://doi.org/10.1002/
emp2.13142.
681 Levy MJ, Garfinkel EM, May ER, et al.
Implementation of a prehospital whole blood
program: Lessons. learned. J Am Coll Emerg
Physicians Open. 2024;5: Apr; 5(2): e13142. https://
doi.org/10.1002/emp2.13142. Krohmer J. Chairman,
steering committee of the Prehospital Blood
Transfusion Initiative Coalition. Virtual Meeting
April 23, 2024.
682 Ibid.
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traumatic medical conditions such as
hemorrhagic shock from a
gastrointestinal bleed.683 Traditional
resuscitation protocol for massive
hemorrhage from trauma and other
medical conditions such as
gastrointestinal bleeding consists of
crystalloid fluids and blood component
transfusions, which consist of a
balanced portion of PBRCs, platelets,
and fresh frozen plasma.684
During the conflicts in Iraq and
Afghanistan, use of this traditional
protocol was difficult due to the austere
combat environment and limited
availability of blood components, which
often necessitated the use of fresh whole
blood (FWB) in traumatic
resuscitation.685 Data collected related
to these conflicts demonstrated
improvements in survival rate and
reductions in transfusion requirements
for military casualties in hemorrhagic
shock who received FWB versus those
receiving traditional blood component
transfusion and spurred research and
interest in the use of WBT in civilian
trauma.686 Additional data
demonstrating an improvement in 24hour and 30-day survival rate among
medically evacuated combat casualties
in Afghanistan who received
prehospital transfusion encouraged
research and interest in these
techniques for possible deployment by
EMS services.687
683 Ibid.
Braverman MA, Smith A, Ciaraglia AV, et al. The
regional whole blood program in San Antonio, TX:
A 3-year update on prehospital and in-hospital
transfusion practices for traumatic and nontraumatic hemorrhage. Transfusion. 2022; 62: S80–
S89.
684 Young PP, Cotton BA, Goodnough LT. Massive
Transfusion Protocols for Patients with Substantial
Hemorrhage. Transfusion Medicine Reviews. 2011,
Vol 25(4). 293–303.
Washington State Department of Health Office of
Community Health Systems Emergency Medical
Services and Trauma Section. Trauma Clinical
Guideline: Massive Transfusion for Trauma.
685 Nessen SC, Eastridge BJ, Cronk D, et al. Fresh
whole blood use by forward surgical teams in
Afghanistan is associated with improved survival
compared to component therapy without platelets.
Transfusion. 2013;53: 107S–13S.
686 Spinella PC, Perkins GJ, Grathwohl KW,
Beekley AC, Holcomb J. Warm Fresh Whole Blood
is Independently Associated with Improved
Survival for Patients with Combat-Related
Traumatic Injuries. J Trauma. 2009 April; 66(4
Suppl): S69–S76. doi:10.1097/
TA.0b013e31819d85fb. Nessen SC, Eastridge BJ,
Cronk D, et al. Fresh whole blood use by forward
surgical teams in Afghanistan is associated with
improved survival compared to component therapy
without platelets. Transfusion. 2013;53: 107S–13S.
Gurney J, Staudt A, Cap A, Shackleford A, et al.
Improved Survival in Critically Injured Combat
Casualties Treated with Fresh Whole Blood by
Forward Surgical Teams in Afghanistan.
Transfusion. 2020;60; S180–S188.
687 Shackelford SA, del Junco DJ, Powell-Dunford
N, Mazuchowski EL, et al. Association of
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In the treatment of civilian patients
with hemorrhagic shock from trauma,
studies have demonstrated that WBT
provides a substantial survival benefit
versus traditional component
therapy,688 especially when provided
early in the prehospital and hospital
settings.689 One study found WBT
increased the survival of such patients
by as much 60 percent and reduced the
need for additional blood products in
the 24-hour period following the initial
transfusion by 7 percent.690 Another
study noted that there was a significant
increase in the 24-hour and 30-day
survival rate in patients suffering from
severe hemorrhage requiring a large
transfusion volume.691
Patients suffering from hemorrhagic
shock require stabilization in the field
and rapid transport to an acute care
hospital to treat the source of
hemorrhage.692 Individuals who are
experiencing hemorrhagic shock
primarily due to blood loss may require
WBT as their only resuscitative
treatment. Each unit of whole blood
takes 5–8 minutes to transfuse.693
Depending on the time needed to
transport and clinical need, patients
generally receive 1–2 units of WBT
during ground transport.694
While there may be variance between
jurisdictions, the protocols for many
EMS systems currently providing WBT
Prehospital Blood Product Transfusion During
Medical Evacuation of Combat Casualties in
Afghanistan with Acute and 30-Day Survival.
JAMA. 2017; 318(16):1581–1591.
688 Hazelton JP, Ssentongo AE, Oh JS, et al. Use
of Cold-Stored Whole Blood is Associated with
Improved Mortality in Hemostatic Resuscitation of
Major Bleeding. A Multicenter Study. 2022. Annals
of Surgery. Vol 276(4). 579–88.
689 b. Torres CM, Kent A, Scantling D, et al.
Association of Whole Blood With Survival Among
Patients Presenting With Severe Hemorrhage in US
and Canadian Adult Civilian Trauma Centers.
JAMA Surg. 2023;158(5):532–540. doi: 10.1001/
jamasurg.2022.6978.
Brill JB, Tang B, Hatton G, Mueck KM, et al.
Impact of incorporating whole blood into
hemorrhagic shock resuscitation: Analysis of 1,377
consecutive trauma patients receiving emergencyrelease uncrossmatched blood products. J Am Coll
Surg. 2022;234(4):408–418.
Guyette FX, Sperry JL, Peitzman AB, et al.
Prehospital blood product and crystalloid
resuscitation in the severely injured patient: a
secondary analysis of the prehospital air medical
plasma trial. Ann Surg. 2021;273:358–364.
690 Ibid.
691 Ibid.
692 Centers for Disease Control and Prevention.
Guidelines for field triage of injured patients.
MMWR. 2009;58 (RR–1):1–34.
693 Vitberg D. Assistant Medical Director. District
of Columbia Fire and EMS Department. Zoom
meeting. February 20, 2024. Bank EA. Assistant
Chief of EMS. Co-Chair of the South East Regional
Advisory Council Trauma Committee. Phone
conversation, May 10, 2024.
694 Krohmer J. Chairman, steering committee of
the Prehospital Blood Transfusion Initiative
Coalition. Virtual Meeting April 23, 2024.
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are designed for patients who require
complex management at the advanced
life support level, demonstrating
suspicion of blood loss along with
evidence of physiologic shock as
indicated by parameters such as low
blood pressure, an elevated pulse rate,
or slow capillary refill.695 Other relevant
factors may include an elevated lactate
level, an EtCO2 waveform capnography
reading <25 as surrogate for elevated
lactate, a shock index (heart rate/
systolic blood pressure) >1, and, where
appropriate and consistent with
protocol, authorization by online or
other medical authority.696
We believe that many ground
ambulance transports providing WBT
already qualify for ALS2 payment, since
patients requiring such transfusions are
generally critically injured or ill and
often suffering from cardio-respiratory
failure and/or shock, and therefore are
likely to receive one or more procedures
currently listed as ALS procedures in
the definition of ALS2, with
endotracheal intubation, chest
decompression, and/or placement of a
central venous line or an intraosseous
line the most probable to be seen in
these circumstances. Patients requiring
WBT are typically suffering from
hemorrhagic shock, for which the usual
course of treatment includes airway
stabilization, control of the hemorrhagic
source, and stabilization of blood
pressure using crystalloid infusion and
the provision of WBT or other blood
product treatments when available, but
not necessarily the administration of
advanced cardiac life support
medications.697 Consequently, we do
not believe it is likely that most patients
who may require WBT would trigger the
other pathway to qualify as ALS2, the
administration of at least three
medications by intravenous push/bolus
or by continuous infusion, excluding
crystalloid, hypotonic, isotonic, and
hypertonic solutions (Dextrose, Normal
Saline, Ringer’s Lactate).
However, not all ground ambulance
transports providing WBT may already
qualify for ALS2 payment. An
ambulance transport would not qualify
for ALS2 payment where a patient
695 Mark H. Yazer, Philip C. Spinella, Eric A.
Bank, Jeremy W. Cannon, Nancy M. Dunbar, John
B. Holcomb, Bryon P. Jackson, Donald Jenkins,
Michael Levy, Paul E. Pepe, Jason L. Sperry, James
R. Stubbs & Christopher J. Winckler (2022) THOR–
AABB Working Party Recommendations for a
Prehospital Blood Product Transfusion Program,
Prehospital Emergency Care, 26:6, 863–875.
Ibid., https://miemss.org/home/Clinicians/WholeBlood.
696 Ibid.
697 Prehospital Hemorrhage Control and
Treatment by Clinicians: A Joint Position
Statement. Ann Emerg Med. 2023;82:e1–e8.
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received only WBT during a ground
ambulance transport, and not one or
more other services that, either by
themselves or in combination, presently
qualify as ALS2. We believe WBT
should independently qualify as an
ALS2 procedure because the
administration of WBT and handling of
low titer O+ whole blood require a
complex level of care beyond ALS1 for
which EMS providers and suppliers at
the EMT-Intermediate or paramedic
level require additional training. In
addition, WBT requires specialized
equipment such as a blood warmer and
rapid infuser.698 While there is no
established national training protocol,
many systems follow the guidelines of
the Association for the Advancement of
Blood and Biotherapies (AABB), which
requires additional training that is 4
hours in length for paramedics and 6
hours in length for EMS supervisory
staff.699 Medicare’s requirements for
ambulance staffing at 42 CFR 410.41(b)
include compliance with state and local
laws, which here would establish
appropriate training requirements with
respect to WBT administration.
Therefore, we believe it is appropriate
to modify the definition of ALS2 to
account for the instances where patients
are administered WBT but do not
otherwise qualify for ALS2 payment. Of
note, we do not have the authority to
provide an additional payment, such as
an add-on payment for the
administration of WBT under the AFS.
We propose to modify the definition
of ALS2 at § 414.605 by adding the
administration of low titer O+ whole
blood transfusion to the current list of
seven ALS2 procedures as a new
number 8. We would also reflect this
change in the Medicare Benefit Policy
Manual, Chapter 10, Ambulance
Services, section 30.1.1, Definition of
Ground Ambulance Services. Under this
proposal, a ground ambulance transport
that provides WBT would itself
constitute an ALS2-level transport.
We are aware that some established
EMS systems may already provide WBT
to treat patients in hemorrhagic shock,
698 Pokorny DM, Braverman MA, Edmundson PM,
et al. The use of prehospital blood products in the
resuscitation of trauma patients; a review of
prehospital transfusion practices and a description
of our regional whole blood program in San
Antionio, TX. ISBT science series, 2018–08, Vol,
14(3), p. 332–42.
Floccare D. Air Medical Director, State of
Maryland. Email communication. May 14, 2024.
Krohmer J. Chairman, steering committee of the
Prehospital Blood Transfusion Initiative Coalition.
Virtual Meeting April 23, 2024.
699 Bank EA. Assistant Chief of EMS. Co-Chair of
the South East Regional Advisory Council Trauma
Committee. Email correspondence and phone
conversation, May 10, 2024.
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while other jurisdictions, including
those in rural areas, will not and often
will rely on alternative blood product
treatments such as PRBCs and plasma.
The availability of WBT in rural areas is
a complex and multifactorial issue.
Fluctuating stock of the ‘‘raw product’’
(blood donations) along with local
healthcare demands for blood products
(PRBCs, platelets, plasma, etc.) affect the
availability of WBT. Other issues in
rural areas include the logistical
challenges and the costs involved in
acquiring fresh units of WBT and
returning any unused units to a
supplier.700
The training, administration and
monitoring is the same for these
alternative blood product treatments as
it is for WBT. While we are not
including alternative blood product
treatments in our proposal, we are
seeking comment on whether we should
add alternative blood product
treatments to the list of ALS2
procedures. We invite comments on this
proposal to add the administration of
low titer O+ whole blood transfusion as
an ALS2 procedure and comments on
whether we should add alternative
blood product treatments such as the
administration of PRBCs or plasma.
O. Medicare Parts A and B
Overpayment Provisions of the
Affordable Care Act
1. Executive Summary
In the proposed rule titled ‘‘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’’, which
appeared in the December 27, 2022
Federal Register, we proposed to amend
our regulations regarding the standard
for an ‘‘identified overpayment’’ under
Medicare Parts A, B, C, and D to align
the regulations with the statutory
language in section 1128J(d)(4)(A) of the
Act, which provides that the terms
‘‘knowing’’ and ‘‘knowingly’’ have the
meaning given those terms in the
Federal False Claims Act (the False
700 Apelseth TO, Strandenes G. Kristofferson K,
Hagen KG. How do I implement a whole bloodbased blood preparedness program in a small rural
hospital? Transfusion. 2020. Vol 60(12) 2793–2800.
Schaefer R, Bank EA, Krohmer J, Haskell A, et al.
Removing the Barriers to Prehospital Blood: A
Roadmap to Success. Journal of Trauma and Acute
Care Surgery. 2024 (manuscript). Currently awaiting
publication.
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Claims Act) at 31 U.S.C. 3729(b)(1)(A)
(87 FR 79452). We refer to that rule as
the ‘‘December 2022 Overpayment
Proposed Rule.’’ In the December 2022
Overpayment Proposed Rule, we
proposed to remove the existing
‘‘reasonable diligence’’ standard and
adopt by reference the False Claims Act
definition of ‘‘knowing’’ and
‘‘knowingly’’ as set forth at 31 U.S.C.
3729(b)(1)(A).
We have not yet finalized our
proposals with respect to overpayments
under Medicare Parts A and B in the
December 2022 Overpayment Proposed
Rule. Instead, after considering the
public comments we received in
connection with the December 2022
Overpayments Proposed Rule, we are
retaining the Parts A and B proposals
published in the December 2022
Overpayment Proposed Rule and we are
now making additional proposals to
revise existing regulations at
§ 401.305(b) regarding the deadline for
reporting and returning overpayments.
2. Provisions of the Proposed Regulation
(Preamble)
Section 6402(a) of the Patient
Protection and Affordable Care Act
(Pub. L. 111–148), as amended by the
Health Care and Education
Reconciliation Act of 2010 (Pub. L. 111–
152) (collectively known as the
Affordable Care Act), established
section 1128J(d) of the Act. Section
1128J(d)(1) of the Act requires a person
who has received an overpayment to
report and return the overpayment to
the Secretary, the State, an
intermediary, a carrier, or a contractor,
as appropriate, and to notify the
Secretary, State, intermediary, carrier or
contractor to which the overpayment
was returned in writing of the reason for
the overpayment. Section 1128J(d)(4)(B)
of the Act defines the term
‘‘overpayment’’ as any funds that a
person receives or retains under title
XVIII or XIX to which the person, after
applicable reconciliation, is not entitled
under such title. For purposes of
Medicare Parts A and B, section
1128J(d)(4)(C) of the Act defines the
term ‘‘person’’ to include providers and
suppliers as those terms are defined in
the Act. Section 1128J(d)(4)(C) of the
Act also defines the term ‘‘person,’’ for
purposes of Medicare Parts C and D, to
also include a Medicare Advantage
organization (MAO) (as defined in
section 1859(a)(1) of the Act) and a Part
D Plan (PDP) sponsor (as defined in
section 1860D–41(a)(13) of the Act).
Section 1128J(d)(2) of the Act requires
that an overpayment be reported and
returned by the later of: (1) the date
which is 60 days after the date on which
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the overpayment was identified; or (2)
the date any corresponding cost report
is due, if applicable. Section 1128J(d)(3)
of the Act specifies that any
overpayment retained by a person after
the deadline for reporting and returning
an overpayment is an obligation (as
defined in 31 U.S.C. 3729(b)(3)) for
purposes of the False Claims Act, 31
U.S.C. 3729.
Section 1128J(d)(4)(A) of the Act
provides that the terms ‘‘knowing’’ and
‘‘knowingly’’ have the meaning given
those terms in the False Claims Act at
31 U.S.C. 3729(b)(1)(A). The False
Claims Act (31 U.S.C. 3729(b)(1)(A))
defines the terms ‘‘knowing’’ and
‘‘knowingly’’ to include information
about which a person ‘‘has actual
knowledge,’’ ‘‘acts in deliberate
ignorance of the truth or falsity of the
information,’’ or ‘‘acts in reckless
disregard of the truth or falsity of the
information.’’
a. Regulations Promulgated Under
Section 1128J(d) of the Act
On May 23, 2014, CMS published a
final rule titled ‘‘Medicare Program;
Contract Year 2015 Policy and
Technical Changes to the Medicare
Advantage and the Medicare
Prescription Drug Benefit Programs’’ (79
FR 29844) (hereinafter referred to as the
‘‘Parts C and D Overpayment Final
Rule’’), which provided, among other
things, that an MAO or PDP sponsor has
identified an overpayment when the
MAO or PDP sponsor has determined,
or should have determined through the
exercise of reasonable diligence, that the
MAO or PDP sponsor has received an
overpayment.
On February 12, 2016, we published
a final rule titled ‘‘Medicare Program;
Reporting and Returning of
Overpayments’’ (81 FR 7654)
(hereinafter referred to as the ‘‘Parts A
and B Overpayment Final Rule’’), which
provided, among other things, that a
provider or supplier has identified an
overpayment when the provider or
supplier has determined, or should have
determined through the exercise of
reasonable diligence, that the provider
or supplier has received an
overpayment and quantified the amount
of the overpayment.
In the December 2022 Overpayment
Proposed Rule, we proposed to amend
the existing regulations for Medicare
Parts A and B, as well as Parts C and
D, regarding the standard for an
‘‘identified overpayment’’ to align the
regulations with the statutory language
in section 1128J(d)(4)(A) of the Act. If
finalized, these regulations would
assign the meaning of the terms
‘‘knowing’’ and ‘‘knowingly’’ in the
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False Claims Act at 31 U.S.C.
3729(b)(1)(A) to our regulations for
purposes of Medicare overpayments.
Specifically, in the December 2022
Overpayment Proposed Rule, we
proposed to remove the existing
‘‘reasonable diligence’’ standard and
adopt by reference the False Claims Act
definition of ‘‘knowing’’ and
‘‘knowingly’’ as set forth at 31 U.S.C.
3729(b)(1)(A). We continue to review
the comments we received on the
December 2022 Overpayment Proposed
Rule, and we plan to respond both to
those comments and the comments we
receive on our new proposals when we
publish the CY 2025 Physician Fee
Schedule final rule.
b. Relevant Litigation
In UnitedHealthcare Insurance Co. v.
Azar, a group of MAOs challenged the
Parts C and D Overpayment Final Rule,
and the District Court held, in relevant
part, that by requiring MAOs to use
‘‘reasonable diligence’’ in searching for
and identifying overpayments, CMS
impermissibly established False Claims
Act liability for mere negligence.
UnitedHealthcare Ins. Co. v. Azar, 330
F. Supp. 3d 173, 191 (D.D.C. 2018),
rev’d in part on other grounds sub nom.
UnitedHealthcare Ins. Co. v. Becerra, 16
F.4th 867 (D.C. Cir. 2021), cert. denied,
142 S. Ct. 2851 (U.S. June 21, 2022) (No.
21–1140). The District Court noted that
‘‘(t)he False Claims Act—which the
ACA refers to for enforcement, see 42
U.S.C. 1320a–7k(d)(3)—imposes
liability for erroneous (‘false’) claims for
payment submitted to the government
that are submitted ‘knowingly’ . . . a
term of art defined in the FCA to
include false information about which a
person ‘has actual knowledge,’ ‘acts in
deliberate ignorance of the truth or
falsity of the information,’ or ‘acts in
reckless disregard of the truth or falsity
of the information.’ ’’ Id. at 190.
Although the court’s ruling applied
only to Medicare Part C, to provide for
consistency in Medicare regulations
related to reporting and returning
overpayments, in the December 2022
Overpayment Proposed Rule, we
proposed to amend the regulations at
current § 401.305(a)(2) to remove the
reference to ‘‘reasonable diligence’’ and
replace it with language incorporating
the terminology of section
1128J(d)(4)(A) of the Act by ascribing
the terms ‘‘knowing’’ and ‘‘knowingly’’
the same meaning given those terms in
the False Claims Act at 31 U.S.C.
3729(b)(1)(A). See UnitedHealthcare,
330 F. Supp. 3d at 191 (finding that this
language would be consistent with a
2000 agency rule, the False Claims Act,
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and the Affordable Care Act’s reference
to the False Claims Act).
c. Provisions of Proposed Regulations
In addition to our earlier proposals,
which remain under consideration, we
make the following new proposals.
Existing § 401.305(b)(1) specifies
when a person who has received an
overpayment must report and return an
overpayment. We propose to amend this
paragraph to reference revised
§ 401.305(b)(2), as well as to reference
newly-proposed § 401.305(b)(3).
Existing § 401.305(b)(2) specifies the
circumstances under which the
deadline for returning overpayments
will be suspended. Overpayments must
be reported no later than the date which
is 60 days after the date on which the
overpayment was identified or the date
any corresponding cost report is due, if
applicable. However, the deadline for
returning a reported overpayment will
be suspended under specified
circumstances, including the
acknowledgement of receipt of a
submission to the OIG Self-Disclosure
Protocol or the CMS Voluntary SelfReferral Disclosure Protocol, or under
specified conditions if a person requests
an extended repayment schedule as
defined in § 401.603. We are proposing
a technical modification to the
introductory language in § 401.305(b)(2)
to acknowledge that this section might
be applicable after the suspension
described in new § 401.305(b)(3) is
complete.
New proposed § 401.305(b)(3) would
specify the circumstances under which
the deadline for reporting and returning
overpayments would be suspended to
allow time for providers to investigate
and calculate overpayments. Proposed
§ 401.305(b)(3)(i) provides that the
deadline to report and return an
overpayment would be suspended if: (1)
a person has identified an overpayment
but has not yet completed a good-faith
investigation to determine the existence
of related overpayments that may arise
from the same or similar cause or reason
as the initially identified overpayment;
and (2) the person conducts a timely,
good-faith investigation to determine
whether related overpayments exist.
Proposed § 401.305(b)(3)(ii) provides
that, if the conditions for proposed
§ 401.305(b)(3)(i) are met, the deadline
for reporting and returning the initially
identified overpayment and related
overpayments that arise from the same
or similar cause or reason as the initially
identified overpayment will remain
suspended until the earlier of the date
that the investigation of related
overpayments has concluded and the
aggregate amount of the initially
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identified overpayments and related
overpayments is calculated, or the date
that is 180 days after the date on which
the initial identified overpayment was
identified.
The following example may elucidate
a hypothetical circumstance. Assume
that, on day 1, a person identifies an
overpayment arising from a physician’s
failure to properly document the
medical record to support the coding of
a specific claim, and the person has
reason to believe that this may be a
common practice of the physician, so
there could be more affected claims. At
this point, the person has up to 180 days
to conduct and conclude a good faith
investigation to determine whether
related overpayments that arise from the
same or similar cause or reason as the
initially identified overpayment exist. If
the person does NOT conduct an
investigation, or the investigation is not
timely or not conducted in good faith,
the identified overpayment must be
reported and returned by day 60. If the
person does conduct a timely, good faith
investigation, suspension of the report
and return obligation under
§ 401.305(b)(3) begins on day 1. The
suspension ends when the investigation
is concluded and the initially identified
overpayment and related overpayments,
if any, are calculated, or by day 180,
whichever is earlier. The overpayment
must be reported and returned within
60 days after either completion of the
investigation or day 180, whichever is
earlier. However, the suspensions
described in § 401.305(b)(2) may also be
applicable. For example, if the person is
reporting the overpayment to the OIG
Self-Disclosure Protocol, as provided for
in § 401.305(b)(2) the overpayment
return requirement may be further
suspended in accordance with that
provision.
We make these proposals because
many of the comments that we received
on the December 2022 Overpayment
Proposed Rule expressed concern that
we proposed to remove the term
‘‘quantified’’ from the original
regulatory text. We believe that our
proposals, especially proposed
§ 401.305(b)(3)(ii)(A), would address
this concern. Other commenters
expressed concern that the December
2022 Overpayment Proposed Rule
proposals removed a perceived 6-month
time period to investigate all
overpayments that was referenced in an
example in the preamble to the original
2016 Parts A and B Overpayment Rule.
The December 2022 Overpayment
Proposed Rule was silent on this point
and did not remove this time period to
investigate overpayments. We
understand the importance of allowing
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time to investigate and calculate
overpayments. Therefore, we propose to
codify this allowance into regulation at
proposed § 401.305(b)(3)(ii).
We solicit comment on these
proposals.
IV. Updates to the Quality Payment
Program
A. CY 2025 Modifications to the Quality
Payment Program
1. Executive Summary
a. Overview
This section of this proposed rule sets
forth proposed changes to the Quality
Payment Program starting January 1,
2025, except as otherwise noted for
specific provisions. We continue to
move the Quality Payment Program
forward, including focusing more on
alignment and new options for
clinicians 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 Meritbased Incentive Payment System (MIPS)
and Advanced Alternative Payment
Models (APMs) for the CY 2025
performance period/2027 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 value-based payment program, by
which the Medicare program rewards
clinicians who provide high-value,
high-quality care to their patients in a
cost-efficient manner. There are two
ways for clinicians who provide
services under the Medicare program to
participate in the Quality Payment
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
§ 414.1305) 701 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 established
performance standards with respect to
701 We note that the term MIPS eligible clinician
is defined in § 414.1305 as including a group of at
least one MIPS eligible clinician billing under a
single tax identification number. We refer readers
to our policies governing group reporting and
scoring under MIPS as set forth in § 414.1310(e).
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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
section 1848(q)(5) of the Act and at
§ 414.1380. Unless we assign a different
scoring weight pursuant to these
exceptions, for CY 2025 performance
period/2027 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 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. In calculating the MIPS
payment adjustment factor for a MIPS
eligible clinician, CMS accounts for
scaling factor and budget neutrality
requirements, as further specified in
section 1848(q)(6) of the Act. CMS then
applies the MIPS payment adjustment
factor to amounts otherwise paid under
Part B with respect to covered
professional services for the MIPS
eligible clinician for the applicable
MIPS payment year such that their
payments for such covered professional
services are increased, decreased, or not
adjusted based on the MIPS eligible
clinician’s final score relative to the
performance threshold.
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.
For the Advanced APM track, 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
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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
CY 2024 performance year receive a
1.88 percent APM Incentive Payment in
the 2026 payment year. Beginning with
the CY 2024 performance year (payment
year 2026), QPs will also receive 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.
We plan to continue developing
policies for the Quality Payment
Program that more effectively reward
high-quality of care for patients and
increase opportunities for Advanced
APM participation. We are continuing
to develop new MIPS Value Pathways
(MVPs) to allow for a more cohesive
participation experience by connecting
activities and measures from the four
MIPS performance categories that are
relevant to a specialty, medical
condition, or a particular population.
As we move into the eighth year of
the Quality Payment Program, we are
proposing the updates set forth in this
section of this proposed rule,
encouraging continued improvement in
clinicians’ performance with each
performance year and driving improved
quality of health care through payment
policy.
b. Summary of Major Proposals
(1) Transforming the Quality Payment
Program
Our National Quality Strategy
(https://www.cms.gov/medicare/quality/
meaningful-measures-initiative/cmsquality-strategy) addresses the urgent
need to advance towards a more
equitable, safe, and outcomes-based
health care system for all individuals.
We have a corresponding cohesive
value-based care strategy for Medicare
along three main pillars: Alignment,
Growth, and Equity.702 We continue to
focus on transforming health care
delivery 703 and our 2030 goal to have
all traditional Medicare beneficiaries in
an accountable care relationship with
702 Update On The Medicare Value-Based Care
Strategy: Alignment, Growth, Equity, Health Affairs
Forefront, March 14, 2024. https://
www.healthaffairs.org/content/forefront/updatemedicare-value-based-care-strategy-alignmentgrowth-equity.
703 Quality in Motion, Acting on the CMS
National Quality Strategy, April 2024. https://
www.cms.gov/files/document/quality-motion-cmsnational-quality-strategy.pdf.
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62007
their health care provider. In pursuit of
this vision, we are driving higher value
care, supporting Advanced APM
participation, increasing alignment to
reduce burden, and promoting health
equity. We are exploring new care
delivery and payment models; for
example, we are considering an
ambulatory care model that would
connect payment to performance for
specialists in the ambulatory setting to
increase the number of specialists who
deliver longitudinal care in an
accountable manner and to support
greater integration between specialty
and primary care. This potential model
would utilize MVPs as a foundation for
assessing specialist performance (refer
to section III.J of this proposed rule). We
are proposing in section II.G.2 of this
proposed rule to make payment for
advanced primary care management
(APCM) services furnished by a
physician or other qualified health care
professional who is responsible for all
primary care (for example, physicians
and non-physician practitioners,
including nurse practitioners, physician
assistants, certified nurse-midwives and
clinical nurse specialists), and serve as
the continuing focal point for all needed
health care services during a calendar
month. This proposed payment would
incorporate several specific, existing
care management and communication
technology-based services into a bundle
and include a performance
measurements requirement that could
be met by reporting the Value in
Primary Care MVP by clinicians billing
for APCM services. We are proposing
that billing practitioners who are not
MIPS eligible clinicians (as defined at
42 CFR 414.1305) would not have to
report the MVP in order to furnish and
bill for APCM services.
Separately, we are implementing
MVPs and subgroup reporting option to
allow clinicians to report on a cohesive
set of measures that more directly reflect
their clinical practice. MVPs allow for
more clinically relevant performance
measurement, engage more specialists
in performance measurement, and help
reduce barriers to APM participation.
While traditional MIPS continues to be
a submission option, we intend to move
to full MVP adoption and to sunset
traditional MIPS in the future.
In section IV.A.3.d of this proposed
rule, we discuss a Request for
Information (RFI) that addresses how we
can best achieve full MVP adoption and
subgroup participation as we plan to
move forward with sunsetting
traditional MIPS and advancing the
three pillars and the National Quality
Strategy. We seek feedback on clinician
readiness to report MVPs, how we
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should ensure there are applicable
MVPs for all clinicians, and what
parameters, including logistical and
regulatory policies, are needed for
multispecialty groups to place clinicians
into subgroups for reporting an MVP
relevant to the scope of care provided.
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(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 six new MVPs around the
following topics: Complete
Ophthalmologic Care, Dermatological
Care, Gastroenterology Care, Optimal
Care for Patients with Urologic
Conditions, Pulmonology Care and
Surgical Care. Complete
Ophthalmologic Care, Dermatological
Care, Gastroenterology Care, Optimal
Care for Patients with Urologic
Conditions, Pulmonology Care, and
Surgical Care.
We are also proposing to modify the
MVP maintenance webinar process to
provide more flexibility on how we
communicate submitted maintenance
recommendations prior to proposing
them formally in rulemaking (refer to
section IV.A.4.a of this proposed rule).
Lastly, 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) MVP Scoring
We are proposing to update the
scoring of population health measures
in MVPs by using the highest score of
all available population health
measures, and we are proposing to
remove the requirement for MVP
Participants to select a population
health measure at the time of MVP
registration. We are also proposing to
modify the MVP scoring policies at
§ 414.1365(d)(3)(ii) with respect to the
cost performance category to refer to,
and therefore align with, our
methodology for scoring cost measures
at § 414.1380(b)(2) under our traditional
MIPS policies.. Additionally, we are
proposing to align MVP scoring with
traditional MIPS policies by removing
references to high- and mediumweighted improvement activities in
MVPs. We are proposing to update MVP
scoring to assign 40 points for each
improvement activity to provide full
credit for the improvement activities
performance category for MVP
Participants who report one
improvement activity. For the MVP
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Promoting Interoperability performance
category, we are proposing to modify
our policy at § 414.1365(c)(4)(i)(A),
requiring a subgroup to submit the
affiliated group’s data for the
performance category, by removing
references to specific performance
periods/MIPS payment years, thereby
permitting subgroups to report data for
this category in this manner for the CY
2025 performance period/2027 MIPS
payment year and beyond.
(c) APM Performance Pathway
We are proposing to create within the
APM Performance Pathway (APP) the
APP Plus quality measure set beginning
with the CY 2025 performance period/
2027 MIPS payment year to align with
the Universal Foundation measures
under the CMS National Quality
Strategy. We are not proposing to
modify the existing APP quality
measure set, which already includes
five of the ten Universal Foundation
measures. Instead, we are proposing to
establish the APP Plus quality measure
set as a second, optional measure set
that would be comprised of all of the
measures in the existing APP quality
measure set and would additionally
incrementally adopt the remaining five
Universal Foundation measures from
the CY 2025 performance period/2027
MIPS payment year through the CY
2028 performance period/2030 MIPS
payment year. Under this proposal, a
MIPS eligible clinician, group, or APM
Entity that reports the APP may choose
to report either the APP quality measure
set or the APP Plus quality measure set.
(d) Data Submission for the Performance
Categories
We are proposing to adopt minimum
criteria for a qualifying data submission
for a MIPS performance period for the
quality, improvement activities, and
Promoting Interoperability performance
categories, which we propose to codify
at § 414.1325(a)(1)(i) through (iii).
Specifically, we are proposing that a
qualifying data submission must
include numerator and denominator
data for at least one MIPS quality
measure from the final list of MIPS
quality measures for the quality
performance category and include a
response of ‘‘yes’’ for at least one
activity in the MIPS improvement
activities Inventory for the improvement
activities performance category. For the
Promoting Interoperability performance
category, we are proposing a qualifying
data submission must include: (1)
performance data, including any claim
of an applicable exclusion, for the
measures in each objective, as specified
by CMS; (2) required attestation
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statements, as specified by CMS; (3)
CMS EHR Certification ID (CEHRT ID)
from the Certified Health IT Product List
(CHPL); and (4) the start date and end
date for the applicable performance
period as set forth in § 414.1320.
We are also proposing to codify our
existing policies governing our
treatment of multiple data submissions
received for the quality and
improvement activities performance
categories at § 414.1325(f)(1). We are
also proposing to modify our policy
governing our treatment of multiple data
submissions received for the Promoting
Interoperability performance category,
which we propose to codify at
§ 414.1325(f)(2). Specifically, for the
quality and improvement activities
performance categories, we are
proposing that for multiple data
submissions received from submitters in
multiple organizations, CMS will
calculate a score for each submission
received and assign the highest of the
scores. For multiple data submissions
received from a submitter in the same
organization, CMS will score the most
recent submission. For the Promoting
Interoperability performance category,
we are proposing to modify our policy
so that, for multiple data submissions
received, CMS would calculate a score
for each data submission received and
assign the highest of the scores.
(e) MIPS Performance Category
Measures and Activities
(i) Quality Performance Category
We are proposing to establish the data
submission criteria for the Alternative
Payment Model (APM) Performance
Pathway (APP) quality measure set;
maintain the data completeness criteria
threshold to at least 75 percent for the
CY 2027 and CY 2028 performance
periods/2029 and 2030 MIPS payment
years; establish a measure set inventory
of 196 MIPS quality measures, of which
193 are available in traditional MIPS
and 3 are available only for utilization
in MVPs; and codify previously
established criteria pertaining to the
removal of MIPS quality measures.
Additionally, in section IV.A.4.e.(1)(e)
of this proposed rule, there are two
quality-related RFIs. The first RFI
pertains to the potential expansion of
the survey modes for the administration
of the Consumer Assessment of
Healthcare Providers and Systems
(CAHPS) for MIPS Survey, particularly
expanding the survey modes from a
mail-phone protocol to a web-mailphone protocol. The second RFI
pertains to the potential development of
a set of guiding principles that would be
utilized for the selection and
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implementation of Patient-Reported
Outcome Measures (PROMs) and
Patient-Reported Outcome Performance
Measures (PRO–PMs).
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(ii) Cost Performance Category
We are proposing to add six new
episode-based measures to the cost
performance category beginning with
the CY 2025 performance period/2027
MIPS payment year: Chronic Kidney
Disease, End-Stage Renal Disease,
Kidney Transplant Management,
Prostate Cancer, Rheumatoid Arthritis,
and Respiratory Infection
Hospitalization. We are also proposing
modifications to two existing episodebased cost measures so that their
specifications reflect re-evaluated
versions: Cataract Removal with
Intraocular Lens (IOL) Implantation
(currently titled Routine Cataract
Removal with IOL Implantation) and
Inpatient (IP) Percutaneous Coronary
Intervention (PCI) (currently titled STElevation Myocardial Infarction
(STEMI) PCI). We are proposing to
adopt a 20-episode case minimum for
the six new episode-based cost
measures. We are also proposing to
maintain the existing case minimums
for the two measures we are proposing
to modify in this rulemaking, which are
a 20-episode case minimum for the IP
PCI measure and a 10-episode case
minimum for the Cataract Removal with
IOL Implantation measure.
Additionally, we are proposing to
update the operational list of care
episode and patient condition groups
and codes to reflect these new and
modified measures that we are
proposing. Lastly, we are proposing to
adopt criteria to specify objective bases
for the removal of any cost measures
from the MIPS cost performance
category, which we are also proposing
to codify at § 414.1350(e).
(iii) Improvement Activities
Performance Category
As part of our regular maintenance of
the improvement activities Inventory,
we are proposing to add two new,
modify two existing, and remove eight
existing improvement activities. The
new activities help fill gaps we have
identified in the Inventory while the
modified and removed activities will
ensure that it includes only the most
meaningful activities that have a clear
path to clinical practice improvement.
In addition, we are proposing two
changes to the traditional MIPS
improvement activities reporting and
scoring policies for the CY 2025
performance period/2027 MIPS
payment year: to eliminate the
weighting of activities and to reduce the
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number of activities to which clinicians
are required to attest to achieve a score
in the improvement activities
performance category. Lastly, we are
proposing to codify seven improvement
activity removal factors to establish
criteria used to identify activities for
potential removal or modification.
(iv) Promoting Interoperability
Performance Category
We do not have any proposals for the
Promoting Interoperability performance
category. We are seeking public
comment on a RFI regarding the Public
Health Reporting and Data Exchange
Objective.
(f) MIPS Final Scoring Methodology
(i) Scoring the Quality Performance
Category
We are proposing to implement
defined topped out benchmarks for
topped out measures in specialty sets
affected by limited measure choice.
Many specialty sets have not had the
measure development that was
envisioned early on the program. As a
result, we have retained topped out
measures to ensure there are applicable
measures. To accommodate for this
limited measure choice and the rising
performance threshold, we are
proposing to remove the 7-point topped
out measure score cap for clinicians
reporting measures included in certain
specialty measures and implement a
benchmarking strategy for affected
measures that would ensure clinicians
with limited measure choice are not
unfairly penalized. Additionally, we are
proposing to apply a Complex
Organization Adjustment for virtual
groups and APM Entities (including SSP
ACOs) reporting eCQMs. We are also
proposing to score Medicare CQMs
using flat benchmarks for their first 2
years in the program consistent with the
Shared Saving Program’s policies.
(ii) Scoring the Cost Performance
Category
We are proposing to modify our
methodology for scoring measures for
the cost performance category beginning
with the CY 2024 performance period/
2026 MIPS payment year. Additionally,
we are proposing to adopt a new cost
measure exclusion policy beginning
with the CY 2025 performance period/
2027 MIPS payment year.
(g) MIPS Payment Adjustments
We are proposing to establish the
mean as the methodology for
determining the performance threshold
for the CY 2025 performance period/
2027 MIPS payment year through the
CY 2027 performance period/2029 MIPS
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payment year. To determine the
performance threshold for the CY 2025
performance period/2027 MIPS
payment year, we are proposing that we
will use the mean of the final scores
from the CY 2017 performance period/
2019 MIPS payment year. Based on the
mean final score from that prior period,
we are proposing to establish a
performance threshold of 75 points for
the CY 2025 performance period/2027
MIPS payment year.
(h) Calculating the Final Score
We are proposing to adopt a new
reweighting policy at
§ 414.1380(c)(2)(i)(A)(10) and
(c)(2)(i)(C)(12). Specifically, we are
proposing that, beginning with the CY
2024 performance period/2026 MIPS
payment year, we may reweight one or
more of the performance categories
(specifically, quality, improvement
activities, or Promoting Interoperability)
where we determine, based on
information submitted to us on or before
November 1st of the year preceding the
relevant MIPS payment year, that data
for a MIPS eligible clinician are
inaccessible or unable to be submitted
due to circumstances outside of the
control of the clinician because the
MIPS eligible clinician delegated
submission of the data to their third
party intermediary, evidenced by a
written agreement between the MIPS
eligible clinician and third party
intermediary, and the third party
intermediary did not submit the data for
the performance category(ies) on behalf
of the MIPS eligible clinician in
accordance with applicable deadlines.
We also are proposing that, to determine
whether to apply reweighting to the
affected performance category(ies), we
will consider: whether the MIPS eligible
clinician knew or had reason to know of
the issue with its third party
intermediary’s submission of the
clinician’s data for the performance
category(ies); whether the MIPS eligible
clinician took reasonable efforts to
correct the issue; and whether the issue
between the MIPS eligible clinician and
their third party intermediary caused no
data to be submitted for the performance
category(ies) in accordance with
applicable deadlines.
(i) Third Party Intermediaries
We are proposing to add a
requirement that CMS-approved survey
vendors must provide information on
the cost of their services beginning with
the CY 2026 performance period/2028
MIPS payment year. These costs will
only be applicable to the CAHPS for
MIPS Survey measure. If this proposal
is finalized, the CAHPS for MIPS Survey
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Vendor Participation Form and the
CAHPS for MIPS Survey Minimum
Business Requirements in the QPP
Resource Library would be updated to
detail the required survey vendor cost
information.
(2) Advanced APM Proposals
(a) Overview of the APM Incentive
Eligible clinicians who meet
threshold levels of participation in
Advanced APMs to become QPs (or
partial QPs) are excluded from MIPS
reporting requirements and payment
adjustments. We assess the level of
participation in Advanced APMs based
on payment amounts or patient counts
as provided in our regulation at
§ 414.1425 using the threshold
percentages specified in § 414.1430. The
threshold percentages are calculated
using the ratio of attributed beneficiaries
to attribution-eligible beneficiaries. A
beneficiary is considered attributioneligible if they meet the six criteria
specified in the definition of
‘‘attribution-eligible beneficiary’’ under
§ 414.1305 of our regulations. We are
proposing to modify the sixth criterion
under the definition of ‘‘attributioneligible beneficiary.’’ Specifically, we
are proposing to include as attributioneligible any beneficiary who has
received a covered professional service
furnished by the eligible clinician
(identified by their National Provider
Identifier (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 All-Payer Option with respect to
payment year 2026 (performance year
2024) in accordance with amendments
made by the CAA, 2024. Relatedly, we
are proposing to amend § 414.1450 to
reflect the statutory APM Incentive
Payment amount for the 2026 payment
year (performance year 2024) of 1.88
percent of the eligible clinician’s
estimated aggregate payments for
covered professional services in
accordance with amendments made by
the CAA, 2024.
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2. Definitions
At § 414.1305, we are proposing to
revise the definition of the following
term:
• Attribution-eligible beneficiary
These terms and definitions are
discussed in detail in the relevant
sections of this proposed rule.
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3. Transforming the Quality Payment
Program
a. Vision and Strategy Overview
Medicare plays a lead role in
transitioning the health care system
away from fee-for-service payment,
which incentivizes the quantity of care,
toward value-based payment, which
incentivizes higher-quality care and
smarter spending. We continue to focus
on transforming health care delivery
and our 2030 goal to have all traditional
Medicare beneficiaries in an
accountable care relationship with their
health care provider. Under accountable
care, a person-centered care team is
responsible for improving quality of
care, care coordination, and health
outcomes for a defined group of
individuals, reducing care
fragmentation, and avoiding
unnecessary costs for individuals and
the health system. We continue to
pursue driving higher value care,
supporting Advanced APM
participation, increasing alignment to
reduce burden, and promoting health
equity. As stated previously (85 FR
50279 and 50284, 86 FR 65394 through
65396), we envision a full transition to
MVP reporting and sunset of traditional
MIPS to support movement towards
value-based payment. Through this
Request for Information (RFI) we seek
feedback on policies to support full
implementation of MVPs.
We have a cohesive value-based care
strategy for Medicare based on three
pillars: Alignment, Growth, and
Equity.704 These pillars are inter-related
and address the following:
• Aligning key aspects of value-based
arrangements across Medicare can help
set the stage for broader synchronization
of our health system and move health
care providers to higher levels of
delivery system transformation.
• Growth of accountable care
relationships in both traditional
Medicare and Medicare Advantage can
improve quality and increase savings for
Medicare beneficiaries by promoting
innovative care delivery that better
provides whole-person care.
• The design of value-based
arrangements in Medicare can be an
important tool for advancing health
equity by encouraging the movement of
care upstream to address the healthrelated social needs and disparities that
can lead to/exacerbate poor health
outcomes.
704 Update On The Medicare Value-Based Care
Strategy: Alignment, Growth, Equity, Health Affairs
Forefront, March 14, 2024. https://
www.healthaffairs.org/content/forefront/updatemedicare-value-based-care-strategy-alignmentgrowth-equity.
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We intend to continue our efforts to
align the Quality Payment Program with
the three pillars and broader CMS
initiatives. One of our CMS National
Quality Strategy goals is to improve
quality and health outcomes across the
health care journey through the
implementation of a ‘‘Universal
Foundation’’ of impactful measures
across all our quality and value-based
programs.705 706 707 Adoption of the
Universal Foundation will focus
clinician attention on specific quality
measures, reduce burden, help identify
disparities in care, prioritize
development of interoperable digital
quality measures, allow for crosscomparisons across programs, and help
identify measurement gaps. We have
identified adult and pediatric measures
for the Universal Foundation to be used
across CMS programs and populations
to the extent they are applicable. For
example, we finalized in the CY 2024
PFS final rule our proposal to
consolidate the previously finalized
Promoting Wellness and Optimizing
Chronic Disease Management MVPs into
a single consolidated Value in Primary
Care MVP which aligns with the adult
Universal Foundation core set of quality
measures (88 FR 80042 through 80047).
In section IV.A.4.c.(2) of this proposed
rule we are proposing the creation of a
new Alternative Payment Model (APM)
Performance Pathway (APP) Plus
quality measure set that incrementally
adopts all ten of the Adult Universal
Foundation measures starting in the CY
2025 performance period/2027 MIPS
payment year. In section
IV.A.4.e.(1)(b)(i) of this proposed rule,
we are proposing MIPS eligible
clinicians, groups, and APM Entities
have the option to report such measures
starting the 2025 performance period/
2027 MIPS payment year. We are
launching the Making Care Primary
(MCP) Model in July 2024 to increase
the number of primary care providers in
value-based care and beneficiaries in
accountable care relationships in eight
States.708 709 The MCP model supports
705 CMS National Quality Strategy. (Centers for
Medicare & Medicaid Services, April 2022). https://
www.cms.gov/files/document/cms-national-qualitystrategy-fact-sheet-april-2022.pdf.
706 The CMS National Quality Strategy: A PersonCentered Approach to Improving Quality. Centers
for Medicare & Medicaid Services, June 2022). The
CMS National Quality Strategy: A Person-Centered
Approach to Improving Quality | CMS (https://
www.cms.gov/blog/cms-national-quality-strategyperson-centered-approach-improving-quality#_
ftn4).
707 Quality in Motion, Acting on the CMS
National Quality Strategy, April 2024. https://
www.cms.gov/files/document/quality-motion-cmsnational-quality-strategy.pdf.
708 https://www.cms.gov/priorities/innovation/
innovation-models/making-care-primary.
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care integration including expected
strengthening of primary care clinicians’
connections with specialists while using
evidence-based behavioral health
screening and evaluation to improve
patient care coordination. This will
include implementation of new modelspecific billing codes that we expect to
result in greater use of e-consults and
expanded ongoing communication
among clinicians with a shared patient.
The quality performance measures
included in the MCP model reflect our
Universal Foundation work to
streamline measures across programs
and test new and innovative measures.
We are proposing in section II.G.2. of
this proposed rule to adopt specific
coding and payment policies for
advanced primary care management
(APCM) services for use by practitioners
who are providing services under this
specific model of ‘‘advanced primary
care’’, beginning January 1, 2025. These
services would be furnished under the
direction of a physician or other
qualified health care professional who is
responsible for all primary care (e.g.,
physicians and non-physician
practitioner, including nurse
practitioner, physician assistant,
certified nurse midwife and clinical
nurse specialist), and serve as the
continuing focal point for all needed
health care services, during a calendar
month. We are proposing three new
APCM codes that would recognize the
resources involved in furnishing
ongoing, beneficiary-centered care
management services under the broad
model of advanced primary care
without paying for each activity
separately while allowing for flexibility
in addressing patient needs. APCM
payment would incorporate several
specific, existing care management and
communication technology-based
services into a bundle and include
performance measurements
requirements that could be met by
reporting the Value in Primary Care
MVP beginning in the CY 2025
performance period/2027 MIPS
payment year. Billing practitioners who
are not MIPS eligible clinicians (as
defined at 42 CFR 414.1305) would not
have to report the MVP in order to
furnish and bill for APCM services. The
Value in Primary Care MVP contains the
Adult Universal Foundation quality
measure set, which is consistent with
the National Quality Strategy goal of
using the Universal Foundation
measures across as many programs as is
709 The CMS Innovation Center’s Strategy to
Support High-quality Primary Care | CMS, https://
www.cms.gov/blog/cms-innovation-centers-strategysupport-high-quality-primary-care.
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feasible.710 The Shared Savings
Program, Innovation Center, and MIPS
continue to collaborate strategically to
develop and elaborate on the long-term
vision and implementation policies for
the Quality Payment Program.
This RFI addresses how we can
achieve full MVP adoption and
subgroup participation as we move
toward the sunsetting of traditional
MIPS and advancing the three pillars
and the National Quality Strategy. We
intend to obtain more meaningful
comparable performance data and to
drive higher value care through MVPs
and to provide as much transparency as
possible as we believe about the timing
for sunsetting traditional MIPS (86 FR
39356). Specifically, we are seeking
feedback on clinician readiness to report
MVPs, how we should ensure there are
applicable MVPs for all clinicians,
including the option of creation of
broadly applicable MVP(s), and what
guidance/parameters are needed for
multispecialty groups to place clinicians
into subgroups for reporting an MVP
relevant to the scope of care provided.
b. The Role of MVPs in Transforming
MIPS
(1) Overview
We are moving towards full
implementation of MVPs, which are a
key component of transforming MIPS.
MVPs connect the MIPS performance
categories to measure quality and
patient experience of care linked to
related costs of care, encourage
improvement of care, simplify MIPS,
and assure accessible health care
performance data and interoperability.
We are implementing MVPs in MIPS to
encourage clinicians to report on
measures that are directly relevant to
their clinical practice and connect the
performance categories to better
measure the value of care and support
care improvements (86 FR 39351).
MVPs may make it easier for MIPS
eligible clinicians to select the measures
and activities that are most relevant to
their practice. Rather than selecting
individual measures and activities from
large inventories to report under
potentially siloed MIPS performance
categories under traditional MIPS,
eligible clinicians who submit an MVP
will have a simplified process of
selecting from a smaller, cohesive set of
measures and activities focused on the
clinician’s performance in rendering
care for a specialty or clinical condition.
MVPs provide a pathway to improve
value, reduce burden, help patients
710 https://www.cms.gov/medicare/quality/cmsnational-quality-strategy/aligning-quality-measuresacross-cms-universal-foundation.
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compare clinician performance to
inform patient choice, and reduce
barriers to movement into Advanced
APMs (86 FR 65391).
In the CY 2024 PFS final rule, we
discussed the potential of developing
policies to raise the bar on quality and
support continuous improvement for
clinicians who consistently perform
well in MIPS (88 FR 79322). At this
time, we are not proposing any changes
related to the continuous improvement
based on feedback received. We are
mindful of changes clinicians are
making to move towards MVP reporting.
MVPs support the measurement and
improvement of specialty and primary
care practice, through a portfolio of
MVPs that address care and clinician
conditions of importance to our
patients. MVPs align the quality
performance category, cost performance
category, and improvement activities
performance category and a
foundational layer of the Promoting
Interoperability performance category
and population health measures. MVPs
encourage the measurement of
performance on a cohesive set of
measures and activities focused on the
clinician’s performance, and over time,
improvement in performance in
rendering care for clinical conditions or
patient populations. Widescale adoption
of MVPs, using a standardized
connected set of measures and activities
for a specialty or medical condition,
may generate important and meaningful
information for patients to be able to
compare performance of clinicians on
the same or similar sets of measures. As
we have greater MVP adoption and
subgroup reporting we expect to obtain
an expanded set of clinical specialty
performance data that will be
meaningful to patients as they choose
clinicians.
(2) Furthering MVP Adoption
We continue to incrementally develop
and maintain MVPs that are relevant
and meaningful for all clinicians who
participate in MIPS to support a full
transition to MVPs. We finalized five
new MVPs in the CY 2024 PFS final rule
(88 FR 79322 through 79323) and
finalized modifications to previously
finalized MVPs (88 FR 79323). We refer
readers to section IV.A.4.a.(1) of this
proposed rule for the discussion of six
additional proposed MVPs addressing a
range of clinical conditions and
specialty care. As we increase the
inventory of MVPs, a greater percentage
of MIPS eligible clinicians may report
MVPs. Based on our internal data the
proposed addition of six MVPs, if
finalized, would allow approximately
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80 percent of specialties participating in
the program to submit applicable MVPs.
In the CY 2022 PFS final rule, we
finalized that voluntary reporting of
MVPs would start in the CY 2023
performance period/2025 MIPS
payment year and to implement MVPs
through a gradual process that allows
MVP Participants and third-party
intermediaries time to adapt to changes
in policy, requirements, and
programming updates that would need
to occur in technology systems (86 FR
65394 through 65396). We support a
gradual movement to MVPs. Existing
flexibility allows organizations and
clinicians to determine whether they are
ready to make the transition to MVP
reporting, and time to familiarize
themselves with MVP policies and
prepare to report MVPs that are relevant
to their practice (86 FR 65396).
Promisingly, based on internal data,
over 750 groups and clinicians
registered to report MVPs for the CY
2023 performance period/2025 MIPS
payment year. We are interested in
learning from early MVP Participants to
understand lessons learned and any
barriers that they encountered or
overcame to enable MVP submission.
We are taking steps to encourage MVP
adoption and expect additional MIPS
eligible clinicians to voluntarily begin
reporting MVPs before the eventual
sunset of traditional MIPS. To engage
clinicians in MVP adoption we provide
MVP webinars and outreach, and our
qpp.cms.gov web page provides
information for clinicians related to
reporting MVPs, our MVP inventory and
MVP development.711 We have
increased our inventory of MVPs
annually and we engage interested
parties in MVP development, including
a 45-day comment period for public
input on MVP candidates each year.712
We are collaborating with the CMS
Innovation Center as new payment
models are explored and developed that
may incorporate specialist or clinical
condition-based MVP reporting. See
section III.J. of this proposed rule for a
Request For Information which seeks
input regarding the design of a future
ambulatory specialty model, which may
leverage MVPs as a foundation for
increasing specialty care provider
engagement in value-based payment.
(3) Sunset of Traditional MIPS
We have discussed in previous PFS
rules our intention to fully transition to
MVPs and sunset traditional MIPS (85
711 MIPS Value Pathways (MVPs) (cms.gov),
https://qpp.cms.gov/mips/mips-value-pathways.
712 MVP Candidate Development & Submission.
https://qpp.cms.gov/mips/mips-value-pathways/
submit-candidate.
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FR 50279 and 50284, 86 FR 65394
through 65396). Continuing to maintain
the traditional MIPS submission option
may impair MVP adoption by clinicians
who have an available MVP. Slow
adoption may delay the benefits of
MVPs which will simplify MIPS and
improve comparable clinician
performance data that helps to drive
value and inform clinician selection by
patients. We solicited public comments
in the CY 2022 PFS proposed rule on
the length of time MVP reporting should
be voluntary and the timing for when
we should sunset traditional MIPS (86
FR 39356). Responding interested
parties supported MVP goals and a
transparent, gradual transition to MVPs
with voluntary MVP reporting, with
adequate time to prepare for reporting
an MVP. Clinicians may take advantage
of voluntary MVP reporting now to gain
experience. We have not proposed a
target year to sunset traditional MIPS;
however, it is critical to develop a plan
to sunset traditional MIPS for the
awareness of all interested parties (such
as MVP Participants, third-party
intermediaries, and health systems) so
they may plan their work accordingly to
coincide with this timeline.
We are developing the timeline for the
full transition to MVPs and are seeking
feedback on clinician readiness for MVP
reporting and MIPS policies needed to
sunset traditional MIPS in the CY 2029
performance period/2031 MIPS
payment year. This timeline would
ensure MVPs may be voluntarily
reported during a period of 6 to 7 years
while traditional MIPS is available,
allowing clinicians time to prepare for
MVP reporting and to engage in the
development of the MVP inventory. As
we plan for the full transition to MVPs,
we appreciate that we must ensure that
any MIPS policies that require
rulemaking to sunset traditional MIPS
are proposed and finalized, and that
adequate prior notice is provided to
clinicians who may need to update their
systems and work processes to report
MVPs. We continue to assess remaining
MVP gaps that must be filled and to
confirm participation options for MIPS
eligible clinicians. We anticipate that
we may be ready to fully transition to
MVPs by the CY 2029 performance
period/2031 MIPS payment year.
Robust MVP availability and clinician
coverage would be a precursor to
sunsetting traditional MIPS. Ideally,
there would be MVPs applicable to a
diverse set of specialties, patient
populations, and clinical conditions;
and we are working towards this. We
acknowledge that, even with a robust
inventory of MVPs, there may be some
clinicians who cannot submit an
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applicable MVP, as currently structured,
due to lack of measures to build a
respective MVP or lack of measure case
counts or specialization that does not
allow reporting of MVP quality
measures and calculation of a cost
measure.
While we are expanding our MVP
portfolio, we are hampered by the
limited number of available quality and
cost measures for certain patient
populations, clinical conditions, and
specialties. We refer readers to section
IV.A.4.a.(1) of this proposed rule which
discusses MVP development and
measure gap areas. We recognize that
resources for measure development are
limited, and measure development must
be prioritized to move forward with
quality and cost measurement for the
greatest impact. We are collaborating
with measure developers and providing
transparency on measure gaps and the
limitations around quality and cost
measure development.
(4) Potential Path Forward
We are aiming to have sufficient
MVPs to meet the goals of the MVP
Framework, allow reporting by all
clinicians in MIPS, sunset traditional
MIPS, and transition fully to MVPs.
Additionally, in the CY 2026
performance period/2028 MIPS
payment year, when subgroup reporting
becomes mandatory for multispecialty
groups that participate in MIPS as MVP
Participants (§ 414.1305; 86 FR 65394
through 65397), we want to ensure there
are opportunities for specialists within
the multispecialty group to submit
MVPs. This will allow us to better
assess the scope of care provided by the
group and provide a wider scope of
clinician performance data to patients.
While we endeavor to create a robust set
of MVPs allowing for participation by
all MIPS eligible clinicians as we sunset
traditional MIPS in the future, we
acknowledge there are constraints,
including measure availability,
hindering attainment of this goal. We
refer readers to section IV.A.4.a.(1). of
this proposed rule for a discussion of
measure gaps and MVP development.
We continue to explore different ways
to increase MVP coverage for as many
MIPS eligible clinicians as possible. The
current MIPS quality and cost measure
inventories contain gaps which affect
both traditional MIPS and MVPs, with
MVPs requiring fewer measures to meet
requirements. Therefore, we are
examining approaches to developing
MVPs to ensure that all MIPS eligible
clinicians have MVPs to report.
Currently, MVPs include performance
measures and activities that are broadly
applicable across specialties in addition
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to quality measures that are specialty/
subspecialty specific. When
subspecialty specific or more focused
measures are implemented, they are
considered for addition to the
corresponding MVP. As stated earlier,
we have made progress with developing
MVPs for the majority of specialties and
priority clinical conditions. However,
we are exploring options of how MVPs
can be further developed to facilitate
greater reporting rates for clinicians
with fewer measures available for their
specialty. We refer readers to the 2025
MVP Needs and Priorities document,713
which identifies measurement gaps and
specialties with limited quality
measures, and often limited outcomes
and high priority measures, and cost
measures.
We are considering approaches that
would assist in making MVPs available
to all MIPS eligible clinicians, however,
all approaches to be more inclusive of
clinicians are hindered by the existing
gaps in quality and cost measures. We
seek comment on approaches that
include expanding finalized MVPs to
include more specialties or
subspecialties related to a care
condition; developing new, broader
MVPs with a different emphasis from
current MVPs focused on a single
specialty or clinical condition; and
developing MVPs for non-patient facing
MIPS eligible clinicians.
• Expand previously finalized MVPs
to include different specialties included
in care delivery for patient population.
The applicability of an MVP could be
expanded through embedding measures
and activities specific to additional
specialties in a relevant MVP, which
may allow a broader array of clinicians
to report the MVP. For example, in
future program years, we may be
interested in expanding the Advancing
Cancer Care MVP to include measures
related to non-patient facing MIPS
eligible clinicians that would support
care to cancer patients, such as
pathologists. A benefit of this approach
would be the expansion of the clinician
specialties who could report a given
MVP, without increasing the number of
stand-alone MVPs. However, the
addition of too many measures and
activities could undermine the goal of
having a smaller, cohesive set of
measures and activities in MVPs.
• Expand previously finalized MVPs
to include subspecialties. The
applicability of an MVP could be
increased by broadening the measures
713 2024 MVP Needs and Priorities. https://qppcm-prod-content.s3.amazonaws.com/uploads/1803/
MIPS%20Value%20Pathways%20(MVPs)
%20Development%20Resources.zip.
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and activities to include additional
subspecialties. For example, we do not
anticipate the development of MVPs for
each surgical subspecialty or type of
surgical procedure, but rather maintain
broader surgical MVPs inclusive of
surgeries that are clinically related yet
support multiple subspecialties and/or
procedures within the surgery specialty.
As an example, lumbar surgical
measures may be included within MVPs
for orthopedic surgeons and
neurosurgeons but would not comprise
a standalone MVP solely focused on
lumbar surgery. Conversely, an
Improving Spine Care MVP could be
developed that encompasses multiple
procedures and aspects of care that
could support use by multiple
specialties, such as orthopedic surgeons
and neurosurgeons. Similar to an
approach that expands MVPs to include
additional specialties, this option
adheres to our goal of having a
meaningful set of MVPs.
• Develop MVPs based on Multiple
Specialty Measure Sets. For specialties
that currently do not have MVP
coverage, we could develop an MVP
applicable to multiple conditions or
specialties that currently do not have
MVP coverage. This approach would
serve as a bridge until new applicable
measures are developed that allow for
creation of individual MVPs for
clinicians without an MVP specific to
their specialty, patient populations
served, or the primary conditions
treated. For example, we do not
currently have an MVP for many nonpatient facing clinicians, but we could
develop an MVP geared towards these
multiple specialty types as a temporary
bridge until more meaningful options
can be finalized. The benefit could be
allowing clinicians early experience in
MVPs until we have additional
specifically specific measures to create
more robust and meaningful MVPs.
However, this approach may replicate
traditional MIPS and fall short of our
MVP vision and goals of a cohesive set
of measures and activities; as clinicians’
performance would still be based upon
the various measures and activities
chosen. Clinicians might repeatedly
choose unlinked measures with high
performance levels rather than
addressing performance areas in need of
improvement and may also lesson the
comparability of performance measures
reported by clinicians providing similar
services.
• Develop MVPs based on CrossCutting and Broadly Applicable
Measures. We may consider building an
MVP which applies to multiple
specialty types by leveraging frequently
reported cross-cutting or broadly
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62013
applicable measures that can be
reported by MIPS eligible clinicians
who currently do not have MVPs
specific to their scope of care. Crosscutting quality measures address
important health issues with clinical
quality actions that can be completed by
a multitude of clinician types, such as
screening and cessation intervention for
tobacco use, screening for high blood
pressure and follow-up and screening
for social drivers of health. Broadly
applicable quality measures can be
submitted by multiple specialties,
including Screening for Depression and
Follow-up Plan; Preventive Care and
Screening: Unhealthy Alcohol Use:
Screening & Brief Counseling, and Use
of High-Risk Medications in Older
Adults. Population-based cost measures,
such as the Total Per Capital Cost
(TPCC) and Medicare Spending per
Beneficiary (MSPB) measures, could be
used in such an MVP. A benefit of
developing new MVPs would be to
create a bridge allowing for early
experience in MVPs for clinicians that
currently have no other MVP reporting
options. MVP development would need
to include examination of approaches to
add additional quality and cost
measures to MIPS. We acknowledge this
is a temporary step towards either a
more robust and meaningful standalone
MVP or expansion of an existing MVP
once specialty specific measures are
developed and finalized for use in
MIPS. We also have concerns that the
MVP would be duplicative in nature to
the Value in Primary Care MVP that
represents concepts related to
promoting wellness and appropriate
chronic disease management, which is
of critical importance in driving positive
health outcomes. However, the broader,
cross-cutting MVP does not appear to
solve the concerns of all specialties
identified in our 2024 MVPs Needs and
Priorities 714 interested in submitting
measures and activities related to their
specialties. Additionally, if we
developed an MVP that relied on
entirely cross-cutting and broadly
applicable measures, we may need
policies to discourage clinicians from
choosing this broad MVP when there is
a more specifically applicable MVP
available. We may explore using claimsbased data to ascertain services
provided and whether a clinical
condition or specialty specific MVP
better matches the type of care delivered
or if a bridge MVP submission fits,
714 2024 MVP Needs and Priorities. https://qppcm-prod-content.s3.amazonaws.com/uploads/1803/
MIPS%20Value%20Pathways%20(MVPs)
%20Development%20Resources.zip.
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potentially within an auditing activity
or tying payment to MVP selection.
• Develop MVPs for Non-Patient
Facing MIPS Eligible Clinicians. We are
considering exploring statutory
flexibilities that could help address
future challenges related to a lack of an
applicable MVP for some clinicians.
Any flexibilities we explore must
support our overall MIPS goals.
Reweighting a performance category, for
example, would mean that the quality
performance category or cost
performance category could be
reweighted in an MVP, and this would
not support performance measurement
to drive value or provide comparable
information for patient use in selecting
clinicians or care teams.
We believe one such flexibility exists
at section 1848(q)(2)(C)(iv) of the Act,
which provides that we must consider
the circumstances of professional types
that typically furnish services that do
not involve face-to-face interaction with
a patient. We refer to these clinicians as
non-patient facing MIPS eligible
clinicians as defined at § 414.1305.
Section 1848(q)(2)(C)(iv) of the Act
further provides that, to the extent
feasible and appropriate, we take into
account such circumstances and apply
to such non-patient facing MIPS eligible
clinicians ‘‘alternative measures or
activities that fulfill the goals of the
applicable performance category.’’ In
doing so, section 1848(q)(2)(C)(iv)(II) of
the Act requires that we consult with
non-patient facing MIPS eligible
clinicians of such professional types or
subcategories. We note that measure
gaps for some non-patient facing MIPS
eligible clinicians, for example
diagnostic radiologists and pathologists,
present challenges in developing a
respective MVP. We refer readers to
section IV.A.4.a.(1) of this proposed rule
for discussion of MVP portfolio
development and specialties with
measure gaps. We are interested in
exploring alternative measures and
activities that would allow us to
measure the performance of non-patient
facing MIPS eligible clinicians.
As we explore various approaches to
enable all MIPS eligible clinicians to
report MVPs, we seek comment on
options, such as expanding previously
finalized MVPs, developing more global
MVPs with broadly applicable measures
as an interim bridge for those clinicians
with too few specialty-specific quality
measures and the potential use of
statutory flexibilities, as we move to full
MVP adoption and sunsetting
traditional MIPS.
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(5) Consideration of MVP Policies and
Requirements
A component of sunsetting traditional
MIPS is examining requirements and
policy that may require revision to
ensure a smooth transition into MVP
reporting. For example, we intend to
assess our current policy which does
not allow virtual groups and opt-in 715
reporters to submit an MVP
(§ 414.1305). We want to understand
additional barriers preventing clinicians
from reporting MVPs, and when
possible, examine MVP policies that
might need to be revised to remove the
barriers. We may undertake these policy
proposals in future rulemaking. We are
interested in feedback on potential
changes required as part of an effort to
accommodate clinicians with few
applicable and available quality and
cost measures, who currently do not
have an MVP available.
We have established a policy which
states that, starting in the CY 2026
performance period/2028 MIPS
payment year, multispecialty groups
must form subgroups to report MVPs (86
FR 65394 through 65397). This policy
will enable a subset of clinicians in a
group to submit measures and activities
in an MVP relevant to the scope of care
provided by the subgroup and will lead
to a more comprehensive evaluation of
services provided by groups. As
described in section IV.A.3.d. of this
proposed rule, we are interested in
feedback on how to balance the MVP
requirement for multispecialty groups to
form multiple subgroups with the
ability of the program to evaluate
specialty care and for patients to have
meaningful information to use when
making care decisions.
c. Mandatory Subgroup Reporting
Requirement
(1) Overview
We have established a voluntary
subgroup participation option for
clinicians choosing to report an MVP
beginning in the CY 2023 performance
period/2025 MIPS payment year. We
have also finalized a mandatory
subgroup reporting requirement for
multispecialty groups choosing to report
as an MVP Participant beginning in the
CY 2026 performance period/2028 MIPS
payment year (§ 414.1305; 86 FR 65394
through 65397). Beginning with the CY
2026 performance period/2028 MIPS
payment year, a single specialty group
may continue to submit data for an MVP
at the group level, and a multispecialty
715 Entities that exceed one or two, but not all
three elements of the low-volume threshold defined
at 42 CFR 414.1305 can opt-in to participate in
MIPS (§ 414.1310(b)(1)(iii) and (b)(2)).
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group must form subgroups to report an
MVP. Under the existing subgroup
reporting policies, a group could place
clinicians providing similar scope of
care into one or more subgroups for
reporting a relevant MVP. The
remaining clinicians under the group
TIN not part of a subgroup could
participate as individuals for reporting
an MVP or traditional MIPS. The entire
group TIN (including the clinicians that
are part of the subgroup) could also
submit data as a group in traditional
MIPS.
Subgroup participation for MVP
reporting will allow group practices to
comprehensively capture the diverse
range of services provided by the
clinicians under a group TIN. We
anticipate subgroup reporting will also
provide clinician information to
patients related to a specific condition
or care needs. Subgroup reporting will
provide specialist information to
primary care clinicians allowing
relevant patient referrals. We finalized
the implementation of the subgroup
reporting option to address public
comments received that the existing
group reporting requirements in MIPS
allow a group to report on broadly
applicable quality measures that are not
representative of the scope of care
provided and do not allow reporting of
quality measures by only a portion of
the clinicians under the group TIN.
(2) Specialty Composition of a Group
We have previously established
definitions for a single specialty group
and a multispecialty group at § 414.1305
(87 FR 70038 through 70040).
Specifically, we stated that a single
specialty group means a group as
defined at § 414.1305 that consists of
one specialty type as determined by
CMS using Medicare Part B claims. A
multispecialty group means a group as
defined at § 414.1305 that consists of
two or more specialty types as
determined by CMS using Medicare Part
B claims. MIPS eligible clinicians can
check their eligibility status (individual,
group, virtual group, APM Entity, optin) on the QPP Participation Status Tool
(https://qpp.cms.gov/participationlookup) to determine their MIPS
participation options and whether they
are subject to MIPS payment adjustment
for the applicable performance period.
Currently, the QPP Participation Status
Tool does not provide information on
group specialty designations informing
a group whether CMS considers its TIN
is composed of a single or multiple
specialties. In the CY 2023 PFS final
rule (87 FR 70039), we discussed that
CMS utilizes different data sources to
identify a clinician’s specialty. For
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purposes of public reporting, we rely on
PECOS as the primary data source, and
for purposes of MIPS eligibility
determination, we use both PECOS and
claims data. Additionally, we use the
information on Medicare Part B claims
to identify clinician specialty when
attributing some of the measures in the
cost and quality performance categories.
Based on CMS analysis of clinician
specialty identification using Medicare
Part B claims data and PECOS data, we
found a variance rate of less than one
percent between the two data sources
and finalized the use of Medicare Part
B claims data as the best data source to
use to determine a group’s specialty
type or types for purposes of
participation in MVPs. We refer readers
to the CY 2023 PFS final rule (87 FR
70038 through 70040) for additional
details on using the Medicare Part B
Claims data to determine a group’s
specialty composition.
We also recognize there are additional
nuances to consider for using the
Medicare Part B claims data to
appropriately implement the current
definitions of a single specialty and
multispecialty group. We acknowledge a
multidisciplinary group practice could
consist of clinicians across multiple
specialties to provide team-based care in
just one clinical area. For example, a
group consisting of internists,
geriatricians, family medicine
practitioners, physician assistants, and
nurse practitioners could be focused on
providing primary care services to
patients, which could be reflected as
multiple specialties in Medicare Part B
claims. Beginning in the CY 2026
performance period/2028 MIPS
payment year, such a group TIN will be
considered a multispecialty group using
the definition described under
§ 414.1305. The internists, geriatricians,
and family medicine practitioners could
inappropriately be identified as unique
specialties resulting in the TIN having
clinicians with more than one primary
specialty designation. Based on our
previously established definition of a
multispecialty group, this TIN will be
required to form subgroups to
participate in MVPs even though all the
clinicians under the group TIN provide
primary care services. This may result
in multiple subgroups under the same
group TIN submitting data for the same
MVP, which would yield redundant
quality measure reporting. Based on the
scope of care provided, all the clinicians
under the TIN could choose to report
the measures and activities in the Value
in Primary Care MVP. Additional
scenarios that we would like to consider
include instances when a primary
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specialty designation of certain clinician
types does not accurately reflect the
scope of care provided. The physician
assistants and nurse practitioners that
are part of a cardiology group would
potentially be involved in care relevant
to stroke, heart failure, and other cardiac
related conditions. The physician
assistants and nurse practitioners that
are part of a large group practice could
be involved in a wide array of services.
In both these instances, the primary
specialty designation of a physician
assistant or nurse practitioner would
only be representative of their education
credentials, and not the scope of care
provided.
One approach we could consider is
providing flexibility for a group practice
to determine and inform CMS of their
specialty composition. We anticipate
that allowing a group TIN to indicate if
they are a single specialty or
multispecialty group could mitigate a
few of the above concerns. We use the
above example of a group consisting of
internists, geriatricians, family medicine
practitioners, physician assistants, and
nurse practitioners focused on
providing primary care services to
patients. By allowing a group TIN to
identify the group’s specialty
composition, the group TIN could
identify as a single specialty group and
report the measures and activities in the
Promoting Wellness MVP as a group.
Providing the ability for groups to
determine their specialty composition
would provide the opportunity for
groups to determine the MVP
participation option that is consistent
with the scope of care. We anticipate it
would eliminate the need for
duplicative reporting, support the teambased care approach, and allow groups
to comprehensively categorize the care
provided by the clinicians in a group.
(3) Establishing Limits on the
Composition of a Subgroup
We envision a future state in the
Quality Payment Program where
specific and highly meaningful clinician
information is available for patients to
determine their care choices while
allowing clinicians to receive targeted
feedback relevant to the scope of care
provided. We anticipate a future state
where a multispecialty group would
only participate as subgroups for
reporting MVPs. We have stated that
one of the long-term goals of MVP and
subgroup reporting is to encourage
team-based care and therefore, have not
established any restrictions on subgroup
formation. Specifically, we do not
expect a subgroup to include only
clinicians from a single specialty as it
might be construed as discouraging
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62015
team-based care. We are also concerned
that the absence of limitations on
subgroup formation would result in a
subgroup mimicking a multispecialty
group in traditional MIPS. A subgroup
of 100 clinicians under a group TIN
could report on an MVP where the
quality measures and activities in the
MVP are applicable only to a subset of
clinicians in the subgroup.
We are considering placing some
limits on the composition of a subgroup
to make subgroups meaningful and meet
the end goals of MVP reporting. We also
believe that a multispecialty group TIN
could use the subgroup formation
criteria as a guidance for placing
clinicians into subgroups relevant to the
scope of care provided. We recognize
that any potential subgroup composition
criteria should not interfere with the
team-based approach for care provided
by clinicians in multispecialty groups.
We are considering whether we could
establish limits on the number of
clinicians per subgroup based on the
size of the overall group TIN. For a
multispecialty group TIN with less than
100 clinicians, should we consider
limiting the maximum size of a
subgroup to 50 clinicians? Similarly for
a multispecialty group TIN with 100+
clinicians, should we consider placing
limits on the minimum size of a
subgroup? We are interested in
approaches that would encourage
multispecialty groups to report more
than one MVP.
We are also considering whether we
could utilize the information on
Medicare claims data to potentially
create subgroup composition
restrictions. For example, we could
identify the care provided by the
clinicians in a group based on the
specific procedures or services
performed by the clinician. We are
considering analyzing subgroups based
on the volume of services billed by the
clinicians in a group practice for a
specific medical condition (for example,
heart failure, joint replacement, etc.) or
a specific procedure (beta blocker
therapy, stent placement, hip and/knee
surgery, etc.). We anticipate this
approach would serve as a guidance for
clinicians such as family practitioners,
physician assistants, internists, etc. who
provide a diverse range of services
across specialty types.
(4) Mandatory Subgroup Reporting for
Small Practice TINs
At § 414.1305, we define a small
practice to mean a TIN consisting of 15
or fewer eligible clinicians during the
MIPS determination period. For a group
of 15 or fewer clinicians, participation
at the group or subgroup level for MVP
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reporting would provide similar
performance information to clinicians
and patients. Therefore, we do not
anticipate additional benefits for
mandating clinicians in a small practice
TIN to split into multiple subgroups for
reporting an MVP. One approach we
could consider is making an exception
for multispecialty small practice TINs
from the mandatory subgroup reporting
requirement for multispecialty practices
beginning in the CY 2026 performance
period/2028 MIPS payment year. This
would alleviate the additional burden
for small practice TINs to form
subgroups and continue to participate as
a group for reporting an MVP. A
multispecialty small practice could
voluntarily participate as subgroups for
comprehensively capturing the diverse
range of services provided by the group.
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d. RFI Questions
We request public comment on
specifically the following questions:
• For those clinicians who submitted
an MVP for the CY 2023 performance
period/2025 MIPS payment year, what
practice level barriers did you overcome
to successfully submit an MVP? How
did you overcome any stated barriers?
For those who did not submit an MVP,
what key barriers impacted your
decision to continue to report
traditional MIPS?
++ For those clinicians who
participated as a subgroup for reporting
an MVP for the CY 2023 performance
period/2025 MIPS payment year, we are
interested to hear the technological
barriers, if any, that impacted the ability
to successfully submit subgroup level
data. We are also interested to hear
feedback from groups on any technical
issues with de-aggregating data
(specifically, the eCQM quality measure
data) at the subgroup level.
• What does meaningful MIPS
participation look like for clinicians
who in the future with the sunset of
traditional MIPS may not have an
applicable MVP, e.g., clinician types
without an MVP due to having less than
four applicable quality performance
measures and less than one cost
measure identified in the 2025 MVP
Needs and Priorities. Should CMS
consider developing a more global MVP
with broadly applicable measures as an
interim bridge for those clinicians with
too few specialty-specific quality
measures, knowing that the measures
may not be as highly relevant to the
clinicians’ scope of care as we would
like? Should flexibilities or alternative
policies such as non-patient facing
clinician policy changes be considered
for clinicians with limited performance
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measures that allow them to participate
in MIPS?
• As subgroup participation becomes
mandatory for multispecialty groups
reporting an MVP beginning in CY 2026,
how can we balance the increase in
burden for groups while allowing
comprehensive reporting on the diverse
range of services provided by the
clinicians in a group? For example,
should we consider limiting the number
of subgroups that a group must form
based on group size and composition?
++ Are there alternative approaches
we could consider for setting limits on
the minimum and maximum number of
subgroups per group TIN?
• Could we consider establishing a
process during MVP registration for
groups to self-identify if the group is
considered a single specialty or
multispecialty group? Are there any
barriers that CMS should be aware of if
we established a process for a group
practice to identify the overall specialty
composition of a group TIN?
• Is it meaningful for a small practice
to form subgroups? What additional
performance information would it
provide to patients and clinicians?
• Are there additional approaches we
should consider for providing guidance
to groups on appropriately placing
clinicians into subgroups based on the
scope of care provided?
Please note, 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.
Respondents are encouraged to
provide complete but concise responses.
This RFI is issued solely for information
and planning purposes; it does not
constitute a Request for Proposal (RFP),
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, CMS is 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
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incurred in response to this RFI; all
costs associated with responding to this
RFI will be solely at the interested
party’s expense. 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.
Please note that CMS will not respond
to questions about the policy issues
raised in this RFI. CMS may or may not
choose to contact individual responders.
Such communications would only serve
to further clarify written responses.
Contractor support personnel may be
used to review RFI responses.
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
U.S. 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. CMS may publicly post the
comments received, or a summary
thereof.
a. CY 2025 MVP Development and
Maintenance
(1) Development of New MIPS Value
Pathways (MVPs)
In the CY 2023 PFS final rule (87 FR
70035 through 70037), we finalized
modifications to the MVP development
process to broaden opportunities for the
general public to provide feedback on
new candidate MVPs prior to the notice
and comment rulemaking process. We
refer readers to the Quality Payment
Program website to review the public
feedback we received for each 2025
MVP candidate (https://qpp.cms.gov/
mips/candidate-feedback).
Through our development processes
for new MVPs (85 FR 84849 through
84856, 87 FR 70035 through 70037), we
aim to gradually develop new MVPs
that are relevant and meaningful for all
MIPS eligible clinicians. In this
proposed rule, we are proposing the
inclusion of six new MVPs titled:
• Complete Ophthalmologic Care;
• Dermatological Care;
• Gastroenterology Care;
• Optimal Care for Patients with
Urologic Conditions;
• Pulmonology Care; and
• Surgical Care.
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We refer readers to Appendix 3 in this
proposed rule for a detailed description
of each proposed new MVP. With the
proposed addition of the six new MVPs,
we estimate approximately 80 percent of
specialties will have applicable MVPs
available for reporting.
Although our intended goal has been
to offer MVPs for all specialties and
subspecialties during the transition from
traditional MIPS to full MVP
implementation (84 FR 40732 through
40740), we acknowledge our existing
portfolio of quality and cost measures
may not be applicable to all specialties
and/or subspecialties. For quality
measures, while most specialties and
subspecialties can report on broadly
applicable quality measures to meet the
reporting requirements for the quality
performance category within an MVP,
some specialties/subspecialties do not
have sufficient robust quality measures
that are specific to their scope of care.
Thus, we continue to explore options
for overcoming challenges to develop
MVPs for those specialties/
subspecialties with limited quality
measures.
For cost measures, while most
specialties have at least one applicable
episode-based cost measure and/or
population-based cost measure, these
measures may not encompass the full
array of care that could be covered by
a given specialty and, in some instances,
some specialties/subspecialties may not
have an applicable cost measure. For
example, the following specialties have
limited cost measures available and
applicable based on the current MIPS
cost measure inventory:
• Diagnostic Radiology;
• Interventional Radiology;
• Optometry;
• Pathology;
• Radiation Oncology; and
• Speech Language Pathology.
Additionally, some specialties have
one or more applicable cost measures,
but subspecialists may not be captured
under these measures. In the case of the
Melanoma Resection measure, it applies
to individual MIPS eligible clinicians,
groups, and subgroups that perform a
sufficient number of melanoma excision
procedures to meet the measure’s case
minimum. Although this measure is
applicable to many dermatologists,
whether a dermatologist is scored on
this measure depends on multiple
factors, including whether they submit
claims on, and are attributed a sufficient
number of qualifying melanoma
excision procedures (minimum of 10
cases as specified under
§ 414.1350(c)(4)) to receive a score on
this cost measure as set forth in
§ 414.1380(b)(2). While there are
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existing policies to reweight the cost
performance category for individual,
groups, and subgroups of MIPS eligible
clinicians that cannot be scored on cost
measures in accordance with
§ 414.1380(b)(2), an MVP cannot be
developed for a specialty/subspecialty if
there is not at least one applicable cost
measure, as finalized in the CY 2021
PFS final rule (85 FR 84472). The intent
of MVPs is to assess MIPS eligible
clinicians, groups, and subgroups across
all performance categories, and
additional cost measures would support
this intent.
We use prioritization criteria from the
CY 2022 PFS final rule (86 FR 65456)
to determine which cost measures to
develop:
• Clinical coherence of measure
concept (to ensure valid comparisons
across clinicians).
• Impact and importance to MIPS
(including cost coverage, clinician
coverage, and patient coverage).
• Opportunity for performance
improvement.
• Alignment with quality measures
and improvement activities to ensure
meaningful assessments of value.
The CY 2022 PFS final rule (86 FR
65457) also established the following
standards for cost measure construction:
• Measures must assign services that
accurately capture the role of attributed
clinicians.
• Measures must have clear, ex ante
attribution to clinicians.
• Measures must be based on episode
definitions that have clinical face
validity and are consistent with practice
standards.
• Measures’ construction
methodology must be readily
understandable to clinicians.
• Measures must hold clinicians
accountable for only the costs they can
reasonably influence.
• Measures must convey clear
information on how clinicians can alter
their practice to improve measured
performance.
• Measures must demonstrate
variation to help distinguish quality of
care across individual clinicians.
• Measure specifications must allow
for consistent calculation and
reproducibility using Medicare claims
data.
As of the CY 2024 performance
period/2026 MIPS payment year, we
have developed and implemented 29
MIPS cost measures, which reflect the
prioritization criteria and input from
interested parties about potential
clinical topics, measure scope, clinically
related services, and potential
challenges or barriers to measurement.
This is a substantial achievement in
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building out the cost measure portfolio
since MIPS began with only two
population-based cost measures, the
Total Per Capita Cost (TPCC) measure
and the Medicare Spending Per
Beneficiary (MSPB) measure.
However, there are still MIPS eligible
clinicians that do not have cost
measures that apply to the major aspects
of their care practice. For example, there
are specialties or clinical topics where
clinically coherent measure concepts
have not yet been identified or where
impact in terms of cost, clinician, or
patient coverage is lower than that of
other measure concepts that were
prioritized for development. Therefore,
we continue to encourage interested
parties to utilize our established prerulemaking processes, such as the Call
for Measures (https://mmshub.cms.gov/
measure-lifecycle/measureimplementation/pre-rulemaking/
overview), to develop and submit
candidate quality and cost measures
relevant to their specialty. Furthermore,
we continue to develop MVPs based on
needs and priorities, as described in the
MVP Needs and Priorities document
(https://qpp-cm-prodcontent.s3.amazonaws.com/uploads/
1803/
MIPS%20Value%20Pathways%20
(MVPs)
%20Development%20Resources.zip). In
section IV.A.3. of this proposed rule, we
discuss our request for information on
Transforming the Quality Payment
Program and solicit feedback on
challenges to adopting MVPs and a
potential path forward for developing
MVPs for MIPS eligible clinicians with
limited measures.
(2) MVP Maintenance Process
In the CY 2023 PFS final rule (87 FR
70037), we finalized a modification to
the annual maintenance process for
MVPs previously finalized in the CY
2022 PFS final rule (86 FR 65410). We
communicated that if we identified any
potentially feasible and appropriate
submitted maintenance
recommendations, we would host a
public facing webinar open to interested
parties and the general public through
which they could offer their feedback on
the potential maintenance updates we
have identified.
In this proposed rule, because we
have had a low volume of submitted
maintenance recommendations in past
years, we are proposing to modify the
MVP maintenance webinar process to
provide us more flexibility in how we
communicate submitted maintenance
recommendations prior to proposing
them formally in rulemaking. Allowing
flexibility in communicating
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recommendations through alternative
webinar formats or other public
communication channels would offer
similar opportunities for public review
and feedback as a live public webinar.
For example, in lieu of a live webinar,
we could choose to communicate
submitted maintenance
recommendations via a pre-recorded
webinar, which will encourage
interested parties to submit their
feedback on the submitted
recommendations in writing by email
before maintenance updates are
formally proposed in rulemaking. It is
important to reiterate this public
webinar process supports our
commitment to consider interested
parties’ feedback when determining
which maintenance updates are
appropriate for inclusion in formal
notice and comment rulemaking. We
request comment on this proposal.
(3) MVP Maintenance Updates to
Previously Finalized MVPs
Between the CY 2022 PFS final rule
(86 FR 65998 through 66031) and the
CY 2023 PFS final rule (87 FR 70037),
we finalized 12 MVPs available for
reporting beginning with the CY 2023
performance period/2025 MIPS
payment year:
• Adopting Best Practices and
Promoting Patient Safety within
Emergency Medicine;
• Advancing Cancer Care;
• Advancing Care for Heart Disease;
• Advancing Rheumatology Patient
Care;
• Coordinating Stroke Care to
Promote Prevention and Cultivate
Positive Outcomes;
• Improving Care for Lower Extremity
Joint Repair;
• Optimizing Chronic Disease
Management;
• Optimal Care for Kidney Health;
• Optimal Care for Neurological
Conditions;
• Patient Safety and Support of
Positive Experiences with Anesthesia;
• Promoting Wellness; and
• Supportive Care for CognitiveBased Neurological Conditions.
In the CY 2024 PFS final rule (88 FR
79978 through 80047), we consolidated
Promoting Wellness and Optimizing
Chronic Disease Management MVPs into
a single primary care MVP titled ‘‘Value
in Primary Care MVP’’ as well as
finalized five additional MVPs available
for reporting beginning with the CY
2024 performance period/2026 MIPS
payment year:
• Focusing on Women’s Health;
• Prevention and Treatment of
Infectious Disorders Including Hepatitis
C and Human Immunodeficiency Virus
(HIV);
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• Quality Care for the Treatment of
Ear, Nose, and Throat Disorders;
• Quality Care in Mental Health and
Substance Use Disorder; and
• Rehabilitative Support for
Musculoskeletal Care.
In this proposed rule, we are
proposing modifications to all 16 MVPs
with the addition and removal of
measures and improvement activities
based on the MVP development criteria
(85 FR 84849 through 84854). Through
these modifications, we can expand
upon the clinical concepts, advance
health equity, address maintenance
requests from the public, and remove
measures and activities that would
either be finalized for removal from
their respective MIPS Inventory or
replaced by more robust measures. In
addition, through the MVP maintenance
process, we are proposing to consolidate
the previously finalized Optimal Care
for Patients with Episodic Neurological
Conditions MVP and the Supportive
Care for Neurodegenerative Conditions
MVP into a single consolidated
neurological MVP titled Quality Care for
Patients with Neurological Conditions
MVP. We refer readers to Appendix 3 of
this proposed rule for the proposed
modifications and detailed descriptions
to the previously finalized MVPs.
b. MVP Requirements and Scoring
In the CY 2022 PFS final rule (86 FR
65411 through 65415), we finalized
policies for MVP reporting
requirements, including subgroup
requirements, which took effect
beginning in the CY 2023 performance
period/2025 MIPS payment year, at
§ 414.1365(c)(1) through (4). We noted
that MVP reporting requirements are
based on the reporting requirements of
traditional MIPS but have some
differences, such as reporting fewer
measures, to reduce MVP reporting
burden and allow for measurement that
is more meaningful by requiring
clinicians to report on measures and
activities that comprehensively reflect
an episode of care or clinical condition
(86 FR 65411).
In the CY 2022 PFS final rule, we
finalized policies for MVP scoring that
took effect beginning in 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 have
adopted the scoring policies from
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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). In this proposed rule, we are
proposing to update the registration
process and scoring policies for
population health measures in the
quality performance category, clarify the
alignment between scoring cost
measures in MVPs and traditional MIPS,
update requirements and scoring
policies for improvement activities in
the improvement activities performance
category, and update the requirements
for subgroup reporting in the Promoting
Interoperability performance category.
We refer readers to section IV.A.4.d.
of this proposed rule for proposed
policies on data submission
requirements; IV.A.4.e.(1)(c)(i) of this
proposed rule for proposed policies on
the data completeness threshold,
IV.A.4.f.(1)(b) of this proposed rule for
proposed policies on scoring of topped
out measures, and scoring virtual groups
and APM Entities (including SSP ACOs)
in the quality performance category;
IV.A.4.f.(1)(d)(ii)(B) of this proposed
rule for proposed benchmarking policies
for scoring the cost performance
category; IV.A.4.e.(3)(b)(iv) of this
proposed rule for proposed policies for
requirements and scoring that remove
medium- and high-weighting from
improvement activities in the
improvement activities performance
category; and IV.A.4.e.(4) of this
proposed rule for current requirements
and a Request for Information (RFI) for
the Promoting Interoperability
performance category.
(1) Quality Performance Category in
MVPs
(a) Background on Population Health
Administrative Claims-Based Measures
In the CY 2021 PFS final rule, we
discussed the inclusion of population
health measures as a part of the
foundational layer of MVPs, to improve
patient outcomes, reduce reporting
burden and costs, and better align with
clinician quality improvement efforts
(85 FR 84856 and 84857). In the CY
2022 PFS final rule we defined a
population health measure as a quality
measure that indicates the quality of a
population or cohort’s overall health
and well-being, such as, access to care,
clinical outcomes, coordination of care
and community services, health
behaviors, preventive care and
screening, health equity, or utilization
of health services (86 FR 65408). We
also discussed in the CY 2022 PFS final
rule the importance of currently
adopted population health measures,
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noting that they capture outcomes
important to patients and thus provide
meaningful information to clinicians so
they can improve their practice, and
discussed the use of population health
measures as the foundational layer in
MVPs to ensure that important areas of
measurement are reflected within all
MVPs (86 FR 65408).
We finalized in the CY 2022 PFS final
rule (86 FR 65414) at § 414.1365(c)(4)(ii)
that an MVP Participant is scored on
one population health measure in
accordance with § 414.1365(d)(1). Since
the MVP population health measures
are administrative claims-based, they do
not require data submission from
clinicians and do not contribute to
reporting burden. To track which
population health measure an MVP
Participant intends to report, we
finalized in the CY 2022 PFS final rule
(86 FR 65417) at § 414.1365(b)(2)(i) that
MVP Participants are required to select
one population health measure at the
time of MVP registration.
(b) Proposal To Use the Highest Score of
All Available Population Health
Measures
In the CY 2022 PFS final rule (86 FR
65421 and 65422) we finalized scoring
rules for population health measures in
MVPs. We finalized at
§ 414.1365(d)(3)(i)(A) that, except as
provided in paragraph (d)(3)(i)(A)(1),
each selected population health
measure that does not have a benchmark
or meet the case minimum requirement
is excluded from the MVP Participant’s
total measure achievement points and
total available measure achievement
points. In cases where an MVP
Participant selects a population health
measure that cannot be scored because
it does not have a benchmark or meet
the case minimum requirement, we do
not score any other population health
measures that may be applicable and
available.
Population health measures are
included in the MVP foundational layer
because they capture outcomes
important to patients (that is,
hospitalizations for acute illness) and
thus provide meaningful information to
clinicians so they can improve their
practice (86 FR 65408). Under the
current policy, we cannot score an MVP
Participant on a population health
measure if the MVP Participant selects
a measure at registration that lacks a
benchmark or if their case volume does
not meet the case minimum requirement
for the selected measure, even if another
measure is applicable and available. In
the CY 2022 PFS final rule (86 FR
65414) we discussed calculating each
population health measure and applying
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the higher score to the quality score,
however, we ultimately proposed and
finalized the current policy to score
only one selected population health
measure to mitigate concerns from
interested parties that not all population
health measures are applicable to all
specialties (86 FR 65414). We now
realize that at the time of registration, an
MVP Participant will not be able to
determine if they will have enough
cases to meet the case minimum
required for scoring the selected
population health measure and will not
know, in advance, how the measure will
score compared to a benchmark.
Requiring an MVP participant to select
the population health measure to be
scored at the time of registration may
penalize an MVP Participant who
selects a population health measure at
MVP registration.
To increase the likelihood that a
population health measure can be
scored, we had considered several
options, including calculating the
population health measure score by
using an average score of all population
health measures that have a benchmark
and meet the case minimum
requirement and using the score of the
population health measure with the
highest number of cases in order to
score the population health measure
that represents the most care provided
by an MVP Participant. However, we
determined these approaches could
result in a lower score for an MVP
Participant that did not correlate to the
MVP Participant’s performance. We also
considered whether an MVP Participant
could select a population health
measure at the time of data submission
when all other measures are reported.
However, population health measures
are calculated by CMS using
administrative claims-based data and
therefore do not require data submission
from clinicians, and administrative
claims-based data is not available for
CMS calculation until at least 60 days
after the end of the reporting period.
Therefore, the MVP Participant would
not know whether they would meet the
case minimum requirement for the
selected population health measure at
the time of data submission.
Because population health measures
in the MVP capture outcomes important
to patients (that is, for example,
hospitalizations for acute illness) and
thus, provide meaningful information to
clinicians so they can improve their
practice, we want to avoid scenarios
where MVP Participants may
inadvertently select a measure that
cannot be scored. As described for
traditional MIPS at § 414.1380(b)(1)(i),
CMS calculates all administrative
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claims-based quality measures and
scores the clinician on each measure for
which there is a benchmark and the
clinician meets the case minimum
requirement. Calculating all population
health measures in MVPs would more
closely align with the policy to calculate
all administrative claims-based quality
measures. Additionally, we have
developed MVPs with a smaller, more
cohesive set of measures and
streamlined reporting requirements. A
policy to take the highest population
health score would increase the
likelihood that an MVP Participant is
scored on a population health measure
and would ensure that MVP Participants
receive the highest possible population
health score that correlates to their
performance.
We are proposing to revise
§ 414.1365(d)(3)(i)(A) to state that for
the CY 2023 through 2024 performance
periods/2025 through 2026 MIPS
payment years, MVP Participants will
be scored on the selected population
health measure and beginning in the CY
2025 performance period/2027 MIPS
payment year, we would use the highest
score of all available population health
measures. If no population health
measure has a benchmark or meets the
case minimum requirement, then the
population health measure is excluded
from the MVP Participant’s total
measure achievement points and total
available measure achievement points.
To apply this policy to subgroups
reporting an MVP, we also propose to
update § 414.1365(d)(3)(i)(A)(1) to
provide that for the CY 2023 through
2024 performance periods/2025 through
2026 MIPS payment years, subgroups
will be scored on the selected
population health measure based on its
affiliated group score, if available, and
beginning in the CY 2025 performance
period/2027 MIPS payment year, a
subgroup is scored on the highest
scoring of all available population
health measures based on its affiliated
group score, if available. If the
subgroup’s affiliated group score is not
available, each such measure is
excluded from the subgroup’s total
measure achievement points and total
available measure achievement points.
We are also proposing to remove the
requirement for an MVP Participant to
select a population health measure at
the time of MVP registration. If we
implement our proposal to calculate
each population health measure for an
MVP Participant and use the
participant’s highest score for
population health measures in MVPs,
there would be no need for the MVP
Participant to select a measure during
registration. We propose to revise
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§ 414.1365(b)(2)(i) to provide that for the
CY 2024 performance period/2026 MIPS
payment year, each MVP Participant
must select an MVP, one population
health measure included in the MVP,
and any outcomes-based administrative
claims-based measure on which the
MVP Participant intends to be scored.
Beginning in the CY 2025 performance
period/2027 MIPS payment year, each
MVP Participant must select an MVP
and any outcomes-based administrative
claims-based measure on which the
MVP Participant intends to be scored.
We seek comment on these proposals.
(2) Cost Performance Category in MVPs
In the CY 2022 PFS final rule, we
finalized at § 414.1365(d)(3)(ii) to use
the methodology established at
§ 414.1380(b)(2)(i) through (v) to score
the cost performance category for MVPs
using the cost measures included in the
MVP that MVP Participants select and
report. The finalized policies at
§ 414.1380(b)(2) score cost measures
based on achievement and improvement
when the case minimum specified
under § 414.1350(c) is met or exceeded
and CMS has determined a benchmark
(86 FR 65422 and 65423). We discussed
in the CY 2022 PFS final rule that
aligning MVP scoring policies with
existing MIPS scoring policies balances
the statutory requirements and goals of
the program with ease of use, stability,
and meaningfulness to MIPS eligible
clinicians (86 FR 65419). We refer
readers to section IV.A.4.f.(1)(d)(ii)(B) of
this proposed rule for proposals to
modify the cost performance category’s
scoring methodology.
To ensure alignment between MVP
and MIPS scoring policies, it is
important that MVP cost performance
category scoring policies refer to the
MIPS policy on how cost measures are
scored. We remind readers that cost
measures are scored based on the
clinician’s performance on the measure
during the performance period
compared to the measure’s benchmark,
as stated at § 414.1380(b)(2). Currently,
§ 414.1365(d)(3)(ii) provides that the
cost performance category score is
calculated for an MVP Participant using
the methodology at § 414.1380(b)(2)(i)
through (v) and the cost measures
included in the MVP that they select
and report. To ensure continued
alignment, we propose to modify
§ 414.1365(d)(3)(ii) to replace the
reference to § 414.1380(b)(2)(i) through
(v) with a broader reference to the cost
performance category scoring policies at
§ 414.1380(b)(2).
We also propose to similarly revise
§ 414.1365(d)(3)(ii)(A). This regulation
currently provides that a subgroup is
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scored on each cost measure included in
the MVP that it selects and reports
based on its affiliated group score for
each such measure, if available. In
addition, § 414.1365(d)(3)(ii)(A)
provides that, if the subgroup’s affiliated
group score is not available for a
measure, the measure is excluded from
the subgroup’s total measure
achievement points and total available
measure achievement points, as
described under § 414.1380(b)(2)(i)
through (v). We propose to modify
§ 414.1365(d)(3)(ii)(A) to replace the
reference to § 414.1380(b)(2)(i) through
(v) with a broader reference to the cost
performance category scoring policies at
§ 414.1380(b)(2).
We seek comment on these proposals.
(3) Improvement Activities Performance
Category in MVPs
The improvement activities
performance category should provide
clinicians with an opportunity to select
from a subset of improvement activities
within an MVP that are relevant to the
clinical topic. In the CY 2022 final PFS
rule (86 FR 65412 and 64513) we
finalized at § 414.1365(c)(3), that an
MVP Participant who reports an MVP
must report one of the following: two
medium-weighted improvement
activities; one high-weighted
improvement activity; or participation
in a certified or recognized patientcentered medical home (PCMH) or
comparable specialty practice as
described at § 414.1380(b)(3)(ii). We
established that MVP Participants
submitting MVPs would report fewer
improvement activities than eligible
clinicians reporting traditional MIPS to
support MVP adoption.
Additionally, in the CY 2022 final
PFS rule (86 FR 65423 and 65424) we
finalized at § 414.1365(d)(3)(iii) that the
improvement activities performance
category score for MVP Participants is
calculated based on the submission of
high- and medium-weighted
improvement activities. We finalized
that MVP Participants would receive 20
points for each medium-weighted
improvement activity and 40 points for
each high-weighted improvement
activity required under § 414.1360 on
which data is submitted in accordance
with § 414.1325 or for participation in a
certified or recognized patient-centered
medical home (PCMH) or comparable
specialty practice, as described at
§ 414.1380(b)(3)(ii). Therefore, to receive
a score of 40 points, or full credit, an
MVP Participant would be required to
submit one high-weighted improvement
activity, or two medium-weighted
improvement activities included in the
MVP. We stated that these requirements
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would provide an incentive for
reporting MVPs, since fewer
improvement activities are required to
receive a full score for the improvement
activities category in an MVP compared
to traditional MIPS (86 FR 65423).
We refer readers to section
IV.A.4.e.(3)(b)(iv) of this proposed rule
for proposals to remove the mediumand high-weighting for improvement
activities in traditional MIPS starting in
the CY 2025 performance period/2027
MIPS payment year. We now propose to
align MVP policies with the traditional
MIPS proposal regarding the weighting
of improvement activities and to reduce
the number of improvement activities
an MVP Participant must submit for an
MVP. Maintaining a lower reporting
burden would encourage reporting
MVPs. We finalized that incentives for
reporting MVPs, including reduced
reporting requirements, allow MVP
Participants to report on a smaller, more
cohesive subset of measures and
activities that are relevant to a given
clinical topic, condition, or episode of
care (86 FR 65419 and 65420).
Therefore, starting in the CY 2025
performance period/2027 MIPS
payment year, MVP Participants would
be required to submit one improvement
activity to achieve 40 points, or full
credit, whereas in traditional MIPS
clinicians would be required to submit
two improvement activities to achieve
full credit for the improvement
activities performance category. We
propose to update reporting
requirements and scoring rules related
to the improvement activities
performance category for MVPs
accordingly.
We propose to revise § 414.1365(c)(3)
to reflect reporting requirements for the
CY 2023 and 2024 performance periods/
2024 through 2026 MIPS payment years
and the reporting requirements
beginning in the CY 2025 performance
period/2027 MIPS payment year. The
revisions proposed at § 414.1365(c)(3)(i)
introductory text and additions
proposed at paragraphs (c)(3)(i)(A)
through (C) would require that an MVP
Participant who reports an MVP, in the
CY 2023 through 2024 performance
periods/2025 through 2026 MIPS
payment years, report one of the
following: two medium-weighted
improvement activities; one highweighted improvement activity; or
participation in a certified or recognized
patient-centered medical home (PCMH)
or comparable specialty practice as
described at § 414.1380(b)(3)(ii).
Additionally, we propose at
§ 414.1365(c)(3)(ii) introductory text and
(c)(3)(ii)(A) and (B), beginning in the CY
2025 performance period/2027 MIPS
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payment year an MVP Participant who
reports an MVP must report either one
improvement activity or participation in
a certified or recognized patientcentered medical home (PCMH), or
comparable specialty practice as
described at § 414.1380(b)(3)(ii). We
seek comment on the proposals.
We also propose to align MVP scoring
with proposed modifications to
traditional MIPS scoring that would
remove the reference to high- and
medium-weighted improvement
activities for scoring and assign 40
points for each improvement activity
submitted by MVP Participants. We
propose at § 414.1365(d)(3)(iii) that in
the CY 2023 through 2024 performance
periods/2025 through 2026 MIPS
payment years, the improvement
activities performance category score is
calculated based on the submission of
high- and medium-weighted
improvement activities. MVP
Participants would receive 20 points for
each medium-weighted improvement
activity and 40 points for each highweighted improvement activity required
under § 414.1360 on which data is
submitted in accordance with
§ 414.1325 or for participation in a
certified or recognized patient-centered
medical home (PCMH) or comparable
specialty practice, as described at
§ 414.1380(b)(3)(ii). Beginning in the CY
2025 performance period/2027 MIPS
payment year, MVP Participants would
receive 40 points for each improvement
activity that is submitted or
participation in a certified or recognized
patient-centered medical home (PCMH)
or comparable specialty practice. We
seek comment on this proposal.
(4) Promoting Interoperability
Performance Category in MVPs
In the CY 2022 PFS final rule, we
finalized at § 414.1365(c)(4)(i) that an
MVP Participant is required to meet the
Promoting Interoperability performance
category’s reporting requirements. We
also finalized at § 414.1365(c)(4)(i)(A)
the requirements for a subgroup
participating in MVP reporting (86 FR
65413 and 65414). Specifically, we
stated that for the CY 2023 and 2024
MIPS performance periods/2025 and
2026 MIPS payment years, an MVP
Participant that is a subgroup is
required to submit its affiliated group’s
data for the Promoting Interoperability
performance category. The submission
of the affiliated group’s data will be on
the subgroup’s behalf. If the affiliated
group chooses to report as a group for
the Promoting Interoperability
performance category, the group will
still be required to submit its own data
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separately and in accordance with the
reporting rules for groups. We refer
readers to the CY 2022 PFS final rule for
additional details (86 FR 65413 and
65414).
We acknowledge the existing
language under § 414.1365(c)(4)(i)(A)
establishes the requirement for a
subgroup to submit its affiliated group’s
data for the Promoting Interoperability
performance category in the
foundational layer of an MVP for only
the CY 2023 and 2024 performance
periods/2025 and 2027 MIPS payment
years. In the CY 2022 PFS final rule, we
stated our intent to assess the
performance of clinicians participating
in subgroups in the Promoting
Interoperability performance category
using subgroup level data to the extent
that it is operationally feasible (86 FR
39371 and 39372). However, as
discussed in the CY 2022 PFS final rule
(86 FR 39371), we heard from interested
parties through the MVP Town Hall (85
FR 84846), that some clinicians would
need additional time to resolve
operational challenges, including
challenges related to configuration of
EHR systems for reporting Promoting
Interoperability data at the subgroup
level. We recognize that clinicians and
interested parties may need additional
time to resolve the technical challenges
related to configuration of EHR systems
for capturing and submitting data at the
subgroup level. We propose that this
subgroup reporting policy for the
Promoting Interoperability performance
category in the MVP they select apply
beyond the CY 2023 performance
period/2025 MIPS payment year and CY
2024 performance period/2026 MIPS
payment years currently specified at
§ 414.1365(c)(4)(i)(A). Specifically, we
propose to modify § 414.1365(c)(4)(i)(A)
by removing the references to the
specific performance periods/MIPS
payment years and provide that an MVP
Participant that is a subgroup is
required to submit its affiliated group’s
data for the Promoting Interoperability
performance category. The proposed
change would allow a subgroup to
continue to submit the affiliated group’s
data for the MVP Promoting
Interoperability performance category
for the CY 2025 performance period/
2027 MIPS payment year and beyond.
We note CMS will continue to monitor
the operational challenges with the EHR
systems and reassess whether subgroups
should be required to submit subgroup
level performance data for the
Promoting Interoperability performance
category.
We request public comment on this
proposal.
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We refer readers to section V.B.8. of
this proposed rule for discussion on the
burden estimates for these proposals.
c. 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 CY 2021
performance period/2023 MIPS
payment year, which was designed as a
reporting and scoring pathway available
only to MIPS APM participants in order
to provide a predictable and consistent
MIPS reporting option to reduce
reporting burden for, and encourage
continued APM participation, by these
clinicians. We also established that,
beginning with the Shared Savings
Program performance year 2021 (CY
2021 performance period/2023 MIPS
payment year), ACOs were required to
report quality data for purposes of the
Shared Savings Program via the APP (42
CFR 425.512(a)(3); 85 FR 84722).
In that same rule, we finalized a
quality measure set (85 FR 84860 and
84861) for purposes of quality
performance category scoring for the
APP. For those MIPS eligible clinicians,
groups, or APM Entities for whom a
given measure is unavailable due to the
size of the available patient population
or who are otherwise unable to meet the
minimum case threshold for a measure,
we established that such measure would
be removed from the quality
performance category score for such
MIPS eligible clinician, group, or APM
Entity (85 FR 84861). The complete
existing APP quality measure set is
shown in Table 53. As indicated in
Table 53, the current APP quality
measure set includes six quality
measures, of which five also are
Universal Foundation measures.
Further, for MIPS eligible clinicians,
groups, and APM Entities reporting
through the APP, we established that we
would not apply the quality measure
scoring cap at § 414.1380(b)(1)(iv) in the
event that a measure in the APP quality
measure set is determined to be topped
out. Because the APP quality measure
set is fixed, we noted that it would not
be appropriate to limit the maximum
quality performance category score
available to APP reporters. Should an
APP quality measure be determined to
be topped out, we would at that time
consider amending the APP quality
measure set through future rulemaking,
if appropriate.
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TABLE 53: Existing APM Performance Pathway Quality Measure Set
Collection T, pe
•
Submitter T, pe
•
Meaningful
Measures 2.0
Area
CAHPS for MIPS
CARPS for MIPS
Survey
Third Party
Intermediary
Patient's
Experience
:001
Diabetes:
Hemoglobin
Ale (HbAlc) Poor
Control
eCQM/MIPS
CQM (a11 APP
reporters)
Web Interface/
Medicare CQM
(SSP ACOs only)
134
Preventive Care
and Screening:
Screening for
Depression and
Fo11ow-up Plan
eCQM/MIPS
CQM (a11 APP
reporters)
Web Interface/
Medicare CQM
(SSP ACOs only)
Controlling High
Blood Pressure
eCQM/MIPS
CQM(allAPP
reporters)
Web Interface/
Medicare CQM
(SSP ACOs only)
Measure Title
321
236
479
484
Hospital-Wide, 30day, All-Cause
Unplanned
Readmission
(HWR) Rate for
MIPS Eligible
MIPS
Clinician Groups
Clinician and
Clinician Group
Risk-standardized
Hospital
Admission Rates
for Patients with
Multiple Chronic
Conditions
Administrative
Claims
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Yes
Mgt. of
Chronic
Conditions
Intermediate
Outcome
Yes
Treatment of
Mental Health
Process
Yes
Mgt. of
Chronic
Conditions
Intermediate
Outcome
NIA
Admissions &
Readmissions
Outcome
No
Administrative
Claims
We stated when finalizing the APP
that the goal of the APP quality measure
set is not necessarily to reflect the
specific quality goals of clinicians
within their respective APMs, but rather
to reduce the burden of reporting on
quality measures twice: once to MIPS
and once to their APMs. We believed
that by using this broadly applicable
population-health-based measure set,
we would enable MIPS APM
participants to focus more of their
energy and attention on the quality
20:32 Jul 30, 2024
UniHrsal
Foundation
Measure
Yes
Yes
BILLING CODE C
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MIPS Eligible
Clinician
Representative of
a Practice
APMEntity
Third Party
Intermediarv
MIPS Eligible
Clinician
Representative of
a Practice
APM Entity
Third Party
Intermediary
MIPS Eligible
Clinician
Representative of
a Practice
APMEntity
Third Party
Intermediarv
M
Teasure
) pe
Patient
Engagement/
Experience
NIA
Admissions &
Readmissions
measures being reported through their
APMs, while relying on a consistent
measure set within the APP from one
year to the next (85 FR 84862).
We also finalized the Web Interface
measure set for the CY 2021 MIPS
performance period within the APP for
Shared Savings Program ACOs only (85
FR 84720 through 84723), and in the CY
2022 PFS final rule, extended this
collection type through CY 2024 (86 FR
65429). In the CY 2024 PFS final rule,
we established the Medicare Clinical
Quality Measure for Accountable Care
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Outcome
Organizations Participating in the
Medicare Shared Savings Program
(Medicare CQM) collection type in the
APP quality measure set and finalized
that the Medicare CQM collection type
would be available to only ACOs
participating in the Shared Savings
Program. Beginning with the 2024
performance year, ACOs in the Shared
Savings Program have the option to
report the Medicare CQM under the
APP on only ‘‘beneficiaries eligible for
Medicare CQMs as defined at § 425.20,
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(2) Establishment of the APP Plus
Quality Measure Set To Align With the
Universal Foundation
Under the goals of the CMS National
Quality Strategy to improve the quality
and safety of healthcare for everyone,716
CMS is implementing a building-block
approach to streamline quality measures
across CMS quality programs for
measuring primary care clinician
performance in the adult and pediatric
populations by leveraging the Universal
Foundation of quality measures. The
Universal Foundation of quality
measures focuses clinicians’ attention
on measures that are meaningful for the
health of broad segments of the
population; reduces provider burden by
streamlining and aligning measures;
advances equity with the use of
measures that will help CMS recognize
and track disparities in care among and
within populations; aids the transition
from manual reporting of quality
measures to seamless, automatic digital
reporting; and permits comparisons
among various quality and value-based
care programs to help the Agency better
understand what drives quality
improvement and what does not.717 The
Universal Foundation, which identifies
a set of key quality measures for use
where relevant throughout CMS
programs, is already reflected in the
Medicaid Core Sets and the Marketplace
Quality Rating System.718 In addition,
in the CY 2024 PFS final rule (88 FR
79321 and 80043), CMS consolidated
the previously finalized Promoting
Wellness and Optimizing Chronic
Disease Management MIPS Value
Pathways (MVPs) into a single
consolidated primary care MVP (Value
in Primary Care MVP) that aligns with
the adult Universal Foundation quality
measures. In the Announcement of CY
2024 Medicare Advantage (MA)
Capitation Rates and Part C and D
Payment Policies, we also solicited
comment on adding the Universal
Foundation measures to Medicare
Advantage and the Part D Star Ratings
Program. We noted that we would take
these comments into consideration in
the future, and that any additional
measures added to the Star Ratings
Program would need to be added
through rulemaking.719 Alignment of
quality measures across CMS programs
allows practitioners to better focus their
quality efforts, reduces administrative
burden, and drives digital
transformation and stratification of a
focused quality measure set to assess
impact on disparities.720
To further advance Medicare’s overall
value-based care strategy, which
emphasizes preventive care and primary
care and to promote greater alignment
within and across CMS’s quality
programs, we are proposing to create the
APP Plus quality measure set within the
APP specifically to incorporate all of the
Adult Universal Foundation measures.
Five of the ten adult Universal
Foundation measures already are
represented in the existing APP quality
measure set for the CY 2025
performance period/2027 MIPS
payment year under policies finalized in
the CY 2024 PFS final rule (88 FR 79113
through 79114). The Universal
Foundation measures included in the
APP quality measure set are listed in
Table 53. The inclusion of half of the
measures in the Universal Foundation
in the existing APP quality measure set
and the recognition that a significant
number of current and potential users of
the APP—those clinicians participating
in MIPS APMs—practice in primary and
preventive care areas that are relevant to
the Universal Foundation make the APP
a meaningful addition to CMS’s efforts
at quality alignment by bringing in
MIPS reporting by MIPS APM
participants and in turn by providing
feedback in the form of their MIPS
quality score to those participants as
they also continue to work towards
advancing the care they provide within
the context of their respective MIPS
APMs.
We note that we are not proposing to
modify the existing APP quality
measure set or the overall framework for
the APP as a reporting and scoring
pathway. For example, the APP will
continue to be available to MIPS eligible
clinicians, groups, and APM Entities
participating in MIPS APMs, meaning
716 https://www.cms.gov/medicare/quality/
meaningful-measures-initiative/cms-qualitystrategy.
717 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.
718 ‘‘Update On The Medicare Value-Based Care
Strategy: Alignment, Growth, Equity’’, Health
Affairs Forefront, March 14, 2024. DOI: 10.1377/
forefront.20240311.141546.
719 Centers for Medicare and Medicaid Services
(2023). Announcement of Calendar Year (CY) 2024
Medicare Advantage (MA) Capitation Rates and Part
C and Part D Payment Policies. Retrieved March 22,
2024 from Announcement of Calendar Year (CY)
2024 Medicare Advantage (MA) Capitation Rates
and Part C and Part D Payment Policies (https://
www.cms.gov/files/document/2024-announcementpdf.pdf).
720 ‘‘Update On The Medicare Value-Based Care
Strategy: Alignment, Growth, Equity’’, Health
Affairs Forefront, March 14, 2024. DOI: 10.1377/
forefront.20240311.141546.
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instead of their all payer/all patient
population’’ (88 FR 79329).
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that only these clinician types will be
able to report and be scored on the APP
Plus quality measure set. We are
proposing that, within the APP, the APP
Plus quality measure set would be a
second measure set distinct from the
existing APP quality measure set that
MIPS eligible clinicians identified on
the Participation List or Affiliated
Practitioner List of an APM Entity
participating in a MIPS APM may
optionally choose to report. Under the
proposal, when an applicable MIPS
eligible clinician, group, or APM Entity
chooses to report the APP beginning in
the CY 2025 performance period/2027
MIPS payment year, they will then
choose whether to report the APP
quality measure set or the APP Plus
quality measure set. For the CY 2025
performance period/2027 MIPS
payment year, the APP Plus quality
measure set would include the current
APP quality measures and two
additional quality measures from the
Adult Universal Foundation measure
set. The measure set would
incrementally add the remaining three
Adult Universal Foundation measures
by the CY 2028 performance period/
2030 MIPS payment year. Specifically,
we are proposing to adopt one new
quality measure beginning with the CY
2026 performance period/2028 MIPS
payment year, and two new quality
measures beginning with the CY 2028
performance period/2030 MIPS
payment year.
We are proposing to revise
§ 414.1367(c)(1) such that each MIPS
eligible clinician, group, or APM Entity
APM that elects to report the APP
would choose to report either the APP
quality measure set or the APP Plus
quality measure set. A MIPS eligible
clinician, group, or APM Entity that
chooses to report the APP Plus quality
measure set for a performance period
would be required to report all available
measures in the APP Plus quality
measure set for that performance period
and would be scored on all such
measures. For example, with respect to
the CY 2026 performance period/2028
MIPS payment year, a MIPS eligible
clinician, group, or APM Entity that
chooses to report the APP Plus quality
measure set would be required to report
all nine MIPS quality measures (to the
extent applicable and available): the
nine measures are the six measures
incorporated from the APP quality
measure set and the three additional
Universal Foundation measures we are
proposing to incrementally adopt in the
APP Plus quality measure set in the CY
2025 and 2026 performance periods/
2027 and 2028 MIPS payment years.
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The clinician would also be scored on
all nine of these measures.
The proposal would incrementally
incorporate into the APP Plus measure
set the Universal Foundation measures
that are not already included in the APP
measure set beginning in the CY 2025
performance period/2027 MIPS
payment year. The Universal
Foundation measure set aligns quality
measures used across CMS programs
and initiatives and is relevant to a
significant subset of the clinicians who
are eligible to report the APP. The APP
Plus quality measure set will allow
MIPS eligible clinicians, groups, and
APM Entities eligible to report the APP
to report Universal Foundation quality
measures, which are used across CMS
programs and initiatives.
The APP Plus quality measure set
would be separate from the APP quality
measure set and would be optional for
a MIPS eligible clinician, group, or APM
Entity to report.721 Although we want to
promote greater familiarity with the
Universal Foundation measures and to
encourage clinicians to use the
Universal Foundation measures through
their MIPS participation, it is important
to continue to allow the APP to serve its
original purpose of offering a
streamlined, stable reporting and
scoring pathway for MIPS APM
participants, who are already
performing practice transformation and
are reporting and being scored on
quality measures within their APMs.
Further, we recognize that while the
Adult Universal Foundation quality
measures are relevant to a significant
portion of clinicians who are eligible to
report the APP, they are not relevant for
all such clinicians. For example, there
are specialists for whom few, if any, of
these measures may be relevant, and we
do not wish to effectively exclude these
clinicians from accessing the benefits of
the APP when they otherwise are
eligible. Moreover, we recognize that as
CMS continues to evolve APM offerings
for specialists, there may be more
clinicians in the future who are
participating in MIPS APMs and would
therefore be eligible for the APP, which
could shift the proportion of clinicians
for whom the Universal Foundation
measures are relevant as compared to
today. For these reasons, we believe it
is important to maintain the existing
APP quality measure set and to continue
to offer it as an option alongside the
proposed APP Plus quality measure set.
721 That said, we note that the Shared Savings
Program is proposing in section [B–G pages].4.(2).a
to require that an ACO report the APP Plus quality
measure set starting with PY 2025.
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For the reasons specified above, we
are proposing to amend § 414.1367(c)(1)
to establish the APP Plus quality
measure set and provide MIPS eligible
clinicians, groups, and APM Entities the
option to report the APP quality
measure set or the APP Plus quality
measure set beginning with the CY 2025
performance period/2027 MIPS
payment year. We request comment on
this proposal.
(3) Measures Proposed for Use in the
APP Quality Measure Set and APP Plus
Quality Measure Sets
In the CY 2021 PFS final rule, we
adopted the current APP quality
measure set (85 FR 84860 and 84861).
Table 53 contains the current APP
quality measure set. We are not
proposing any changes to the existing
APP quality measure set for the CY 2025
performance period/2027 MIPS
payment year or successive years.
We are proposing a phased approach
to establish the APP Plus quality
measure set over four years. By the CY
2028 performance period/2030 MIPS
payment year, the APP Plus quality
measure set would consist of the
measures currently contained in the
APP quality measure set and five
additional quality measures from the
Universal Foundation measure set. We
are proposing to phase in these new
measures over time to allow for both the
eCQM and, for Shared Savings ACOs,
Medicare CQM collection types to be
developed and become available.
Specifically, we are proposing that the
APP Plus quality measure set will
consist of the six measures currently
contained in the APP quality measure
set and the following five new
measures, which will be added
incrementally:
• Beginning with the CY 2025
performance period/2027 MIPS
payment year and subsequent
performance periods: The Breast Cancer
Screening (Quality #: 112) and
Colorectal Cancer Screening (Quality #:
113) measures. These measures are
currently available as eCQMs, MIPS
CQMs, and Medicare Part B Claims
measures. If this proposal is finalized,
we would make the Medicare CQM
collection type available for these
measures prior to the start of
performance year 2025 only for Shared
Savings Program ACOs.
• Beginning with the CY 2026
performance period/MIPS payment year
2028 and continuing for subsequent
performance periods: The Initiation and
Engagement of Substance Use Disorder
Treatment (Quality #: 305) measure.
This measure is currently available as
an eCQM. If this proposal is finalized,
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we would make the Medicare CQM
collection type available for this
measure prior to the start of
performance year 2026 and only for
Shared Savings Program ACOs.
• Beginning with the CY 2028
performance period/2030 MIPS
payment year and continuing for
subsequent performance periods: The
Screening for Social Drivers of Health
(Quality #: 487) and Adult
Immunization Status (Quality #: 493)
measures. These measures are currently
available as MIPS CQMs, but are not
currently available as eCQMs or
Medicare CQMs. Because developing
eCQM specifications typically takes
three years, we are proposing to add
these measures to the APP Plus quality
measure set in the CY 2028 performance
period/2030 MIPS payment year. If this
proposal is finalized, we would make
these measures available prior to the
start of CY 2028 performance period/
2030 MIPS payment year to report as
eCQMs and, for Shared Savings Program
ACOs only, Medicare CQMs.
As discussed above, we intend to
incorporate the Adult Universal
Foundation measures in the APP Plus
quality measure set. We note that the
additional Universal Foundation
measures that we propose to include in
the APP Plus quality measure set align
with national condition-specific
initiatives and CMS priorities. Below,
we briefly discuss each new Universal
Foundation measure that would be
added to the APP Plus quality measure
set and that is not already included in
the APP quality measure set: Breast
Cancer Screening and Colorectal Cancer
Screening Measures.
Our proposed addition of the Breast
Cancer Screening (Quality #: 112) and
Colorectal Cancer Screening (Quality #:
113) measures to the APP Plus quality
measure set for CY 2025 performance
period and subsequent performance
periods aligns with the President and
First Lady’s Cancer Moonshot initiative,
of which a key objective is to ‘‘make
sure everyone has access to cancer
screenings—so more Americans can
catch cancer early, when outcomes are
best.’’ 722 Breast cancer and colorectal
cancer are two of the most common
types of cancers, accounting for an
estimated 23 percent of all new cancer
diagnoses in the United States in
2023.723 Because the risk of developing
722 The White House (n.d.). The President and
First Lady’s Cancer Moonshot. Accessed March 28,
2024. https://www.whitehouse.gov/
cancermoonshot/.
723 Siegel, R.L., Miller, K.D., Wagle, N.S., & Jemal,
A. (2023). Cancer statistics, 2023. CA: a cancer
journal for clinicians, 73(1), 17–48. https://doi.org/
10.3322/caac.21763.
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these types of cancers increases with
age, the Breast Cancer Screening
measure focuses on mammogram
screening for breast cancer every 24
months starting at age 50 and the
Colorectal Cancer Screening measure
focuses on appropriate screening for
colorectal cancer once per performance
period, also starting at age 50.
Additionally, the February 2024
preliminary measure specifications for
the eCQM version of Colorectal Cancer
Screening lower the starting age for
screenings to 45, an update that aligns
with United States Preventive Services
Task Force recommendation that
colorectal cancer screening begin at age
45 to reduce risk of death.724
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(ii) Initiation and Engagement of
Substance Use Disorder Treatment
Measure
An estimated 48.7 million Americans
aged 12 or older (17.3 percent of the
population) were classified as having
had a substance use disorder (SUD) in
the past year in 2022.725 These
individuals are at an increased risk for
having major medical conditions,
injury, overdose, and death.726
Outcomes for individuals with SUDs are
improved through early and regular
treatment.727 The Initiation and
Engagement of Substance Use Disorder
Treatment (Quality #: 305) measure
ensures patients 13 years of age and
older with a new SUD episode have the
initiation of intervention or medication
within 14 days of the new SUD episode
or engage in ongoing treatment,
including two additional interventions
724 eCQI Resource Center (2023). Colorectal
Cancer Screening. Accessed March 29, 2024.
https://ecqi.healthit.gov/ecqm/ec/2024/
cms0130v12?compare=2024to2023. United States
Preventative Task Force (2021). Final
Recommendation on Screening for Colorectal
Cancer. https://
www.uspreventiveservicestaskforce.org/uspstf/sites/
default/files/file/supporting_documents/colorectalcancer-screening-final-rec-bulletin.pdf.
725 Substance Abuse and Mental Health Services
Administration. (2023). Key substance use and
mental health indicators in the United States:
Results from the 2022 National Survey on Drug Use
and Health (HHS Publication No. PEP23–07–01–
006, NSDUH Series H–58). Center for Behavioral
Health Statistics and Quality, Substance Abuse and
Mental Health Services Administration. https://
www.samhsa.gov/data/report/2022-nsduh-annualnational-report. https://www.ncbi.nlm.nih.gov/pmc/
articles/PMC5291754/.
726 Bahorik, A.L., D.D. Satre, A.H. Kline-Simon,
C.M. Weisner, C.L. Campbell. 2017. ‘‘Alcohol,
Cannabis, and Opioid Use Disorders, and Disease
Burden in an Integrated Health Care System.’’ J
Addiction Medicine 11(1),3–9. https://
www.ncbi.nlm.nih.gov/pmc/articles/PMC5291754/.
727 Kampman, K., K. Freedman. 2020. ‘‘American
Society of Addiction Medicine (ASAM) National
Practice Guideline for the Treatment of Opioid Use
Disorder: 2020 Focused Update.’’ Journal of
Addiction Medicine 14, no. 2S: 1–91, https://
doi.org/10.1097/ADM.0000000000000633.
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or short-term medications, or one longterm medication within 34 days of the
initiation of treatment. This measure
also supports CMS efforts to reduce
deaths related to opioid overdoses,
which have significantly increased in
recent years,728 and the CMS Behavioral
Health Strategy.729
(iii) Screening for Social Drivers of
Health Measure
In the CY 2023 PFS proposed rule, we
sought comment on the potential future
inclusion of the Social Drivers of Health
measure in the APP quality measure set
(87 FR 46154 through 46155). While the
majority of commenters were generally
supportive of adding the Screening for
Social Drivers of Health measure,
several raised concerns related to the
undue burden on collection, cost and
resources of implementation, and
holding providers accountable for the
collection of data which could be
beyond their scope or ability. Some
supportive commenters appreciated that
the Screening for Social Drivers of
Health measure could drive the
standardization of measures that
examine social drivers of health in
Federal health care quality and payment
systems, and that this would ultimately
drive the health of our patients and our
Nation, maximize the use of limited
Government resources to support
vulnerable patients, and achieve quality
improvement and equity in health
outcomes. Commenters further stated
that the Screening for Social Drivers of
Health measure is crucial in recognizing
the impact of Social Drivers of Healthrelated issues on patients and providers,
in laying the foundation to invest in
those communities, and in avoiding
fragmentation and provider/patient
burden by supporting alignment across
public and private quality and payment
programs. Some commenters opposed
the addition of the measure and
cautioned CMS to test it before it would
be required. Other opposed commenters
voiced their concern about the undue
burden on data collection among
patients and providers and the costs and
resources associated with implementing
new Social Drivers of Health measures,
and that gathering Social Driver of
Health measure data would lead to
holding providers accountable for
addressing social needs of patients that
is beyond a provider’s scope or ability.
728 National Institute on Drug Abuse (2023). Drug
Overdose Deaths. Accessed March 28, 2024. https://
nida.nih.gov/research-topics/trends-statistics/
overdose-death-rates.
729 Centers for Medicare and Medicaid Services
(2024). CMS Behavioral Health Strategy. Accessed
April 19, 2024. https://www.cms.gov/cmsbehavioral-health-strategy.
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We believe that the benefits of adding
the measure to the APP Plus quality
measure set outweigh these concerns.
For example, while the challenges and
concerns noted previously in this
section associated with implementing
screening for social drivers of health are
voiced by family medicine clinicians,
social workers, and clinical staff,
including the potential negative impact
screening could have on the patientclinician relationship, screening for
social drivers of health uncovers patient
needs, allows clinicians to provide their
patients with resources or referrals,
results in appropriately adapting patient
care, and prioritizes patient safety.730
The addition of the Screening for Social
Drivers of Health (Quality #: 487)
measure also is consistent with our
priorities to advance health equity and
move toward whole-person care
throughout our various programs,
including the MIPS and the Hospital
Inpatient Quality Reporting (HICR)
programs. This measure addresses five
social and economic determinants—
namely, food insecurity, housing
instability, transportation needs, utility
difficulties, and interpersonal
safety 731—that are central to the Health
Equity strategic plan pillar (https://
www.cms.gov/pillar/health-equity) and
have been identified as both a
measurement priority and a
performance gap among CMS programs.
The movement to address
socioeconomic, environmental, and
behavioral health factors (referred to as
drivers of health) has gained traction
after a study estimated that only 20
percent of a person’s health outcomes
are linked to their medical care with the
remaining 80 percent attributable to
drivers of health.732 Because of the
strong relationship between Social
Drivers of Health and physical health
outcome, screening for Social Drivers of
Health would support the goals of
improving health outcomes by
providing clinicians with a more
comprehensive understanding of each
patient’s circumstances to inform
730 Porterfield, L., Jan, Q.H., Jones, F., Cao, T.,
Davis, L., Guillot-Wright, S., & Walcher, C.M.
(2024). Family Medicine Team Perspectives on
Screening for Health-Related Social Needs. Journal
of the American Board of Family Medicine: JABFM,
jabfm.2023.230167R3. Advance online publication.
https://doi.org/10.3122/jabfm.2023.230167R3.
731 https://qpp.cms.gov/docs/QPP_quality_
measure_specifications/CQM-Measures/2023_
Measure_487_MIPSCQM.pdf.
732 Hood, C.M., K.P. Gennuso, G.R. Swain, and
B.B. Catlin. 2016. County health rankings:
Relationships between determinant factors and
health outcomes. American Journal of Preventive
Medicine 50(2):129–135. https://doi.org/10.1016/
j.amepre.2015.08.024.
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clinical decision making and ensure
high-quality care.
In addition, many of these drivers of
health are not only linked to poorer
health, but disproportionately impact
communities of color and underserved
populations. Through screening, once
per performance period, of patients 18
years and older for food insecurity,
housing instability, transportation
needs, utility difficulties, and
interpersonal safety, screening for Social
Drivers of Health and appropriate
referrals can potentially improve health
outcomes and reduce health disparities.
As we indicated when we proposed to
adopt Screening for Social Drivers of
Health in MIPS in the CY 2023 PFS
proposed rule, we believe that
consistently addressing drivers of health
will have two significant benefits. First,
because drivers of health
disproportionately impact individuals
and communities that are disadvantaged
and/or underserved by the healthcare
system, the promotion of screening for
these factors would support clinician
practices and health systems in
actualizing an expressed commitment to
address disparities in care,
implementing associated equity
measures to track progress, and
improving overall health equity.733
Second, patient-level driver of health
data through screening is essential in
the long-term to encourage meaningful
collaboration among clinicians and
community-based organizations, and
implement and evaluate related
innovations in healthcare and social
service delivery. (87 FR 46280)
(iv) Adult Immunization Status Measure
The Adult Immunization Status
measure (Quality #: 493) ensures that
adults are up to date with the
recommended routine vaccines:
influenza; tetanus and diphtheria (Td)
or tetanus, diphtheria and acellular
pertussis (Tdap); zoster; and
pneumococcal. This robust measure
supports the comprehensive evaluation
of compliance with recommended adult
immunizations that improve quality
care and prevent disease.
lotter on DSK11XQN23PROD with PROPOSALS2
733 American
Hospital Association. (December,
2020). Health Equity, Diversity & Inclusion
Measures for Hospitals and Health System
Dashboards. Available at https://ifdhe.aha.org/
system/files/media/file/2020/12/ifdhe_inclusion_
dashboard.pdf.
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(v) Maintaining the Use of the Clinician
and Clinician Group Risk-Standardized
Hospital Admission Rates for Patients
With Multiple Chronic Conditions
Measure in the APP Quality Measure
Set and Including It in the APP Plus
Quality Measure Set
We note that Clinician and Clinician
Group Risk-standardized Hospital
Admission Rates for Patients with
Multiple Chronic Conditions (Quality #
484) is an administrative claims-based
measure that is in the APP quality
measure set for the MIPS CY
performance period 2025/2027 payment
year under policies finalized in the CY
2024 PFS final rule (88 FR 79113 and
79114) but is not one of the ten Adult
Universal Foundation measures. Our
proposal would continue to maintain
this measure in the APP quality measure
set, and therefore also include it in APP
Plus quality measure set, for the CY
2025 performance period/2027 MIPS
payment year and subsequent
performance periods. We continue to
believe that hospital admission rates are
an effective marker of ambulatory care
quality. As noted in our rationale for
adopting the measure in the measure
specifications, ‘‘Hospital admissions
from the outpatient setting reflect a
deterioration in patients’ clinical status
and as such reflect an outcome that is
meaningful to both patients and
providers.734 Patients receiving optimal,
coordinated high-quality care should
use fewer inpatient services than
patients receiving fragmented, lowquality care. Thus, high population rates
of hospitalization may signal poor
quality of care or inefficiency in health
system performance. Furthermore, these
effects may be exacerbated in
disadvantaged areas.735 Patients with
734 Centers for Medicare and Medicaid Services—
Quality Payment Program (2023). Measure
information for the Multiple Chronic Care
Conditions (MCC) Risk-standardized Hospital
Submission Rate for Patients for the Merit-based
incentive Payment System (MIPS) Groups,
Performance Year (PY)2023 MCC Measure Code
Specifications, Retrieved March 22, 2024 from 2023
Clinician and Clinician Group Risk-standardized
Hospital Admission Rates for Patients with
Multiple Chronic Conditions—QPP. https://qppcm-prod-content.s3.amazonaws.com/uploads/2202/
2023%20MIPS%20Multiple
%20Chronic%20Conditions%20Measure
%20Specifications.zip.
735 Jencks, S.F., et al. (2019). ‘‘Safety-Net
Hospitals, Neighborhood Disadvantage, and
Readmissions Under Maryland’s All-Payer Program:
An Observational Study.’’ Ann Intern Med. doi:
10.7326/M16–2671.
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multiple chronic conditions are at high
risk for hospital admission, often for
potentially preventable causes, such as
exacerbation of pulmonary disease.’’ 736
Maintaining this measure in the APP
quality measure set and, as a
consequence, including it in the APP
Plus quality measure set also is
consistent with our previously stated
goals in the CY 2021 PFS final rule to
align the APP with the Meaningful
Measures framework, an initiative to
remove lower value quality measures
across CMS programs while keeping
measures that have less burden and are
the most meaningful with the greatest
impact on patient outcomes. This
measure supports the framework’s goals
as it is identified among the highest
priorities for quality measurement and
improvement while also reducing
burden, promoting alignment, moving
payment toward value, and identifying
key quality performance metrics for
consumers (85 FR 84726).
(vi) The APP and APP Plus Quality
Measure Sets Beginning With the CY
2025 Performance Period/2027 MIPS
Payment Year
Table 54 identifies the measures in
the Adult Universal Foundation
measure set, crosswalks them to
corresponding MIPS measures, and lists
the proposed timeline for their
incorporation into the APP Plus quality
measure set between the CY 2025 and
2028 performance periods/2027 and
2030 MIPS payment years as they
become available for both the eCQM and
Medicare CQM collection types. We
note that Clinician and Clinician Group
Risk-standardized Hospital Admission
Rates for Patients with Multiple Chronic
Conditions (Quality # 484) is not one of
the ten Adult Universal Foundation
measures and is not listed in Table 19;
however, we are maintaining reporting
of this measure in the APP quality
measure set, and, as such, also
proposing to include it in the APP Plus
quality measure set for the CY 2025
performance period/2027 MIPS
payment year and subsequent
performance periods.
BILLING CODE P
736 Abernathy, K., Zhang, J., Mauldin, P., Moran,
W., Abernathy, M., Brownfield, E., & Davis, K.
(2016). Acute Care Utilization in Patients With
Concurrent Mental Health and Complex Chronic
Medical Conditions. Journal of primary care &
community health, 7(4), 226–233. https://doi.org/
10.1177/2150131916656155.
E:\FR\FM\31JYP2.SGM
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Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62027
TABLE 5:4: Alignment of the APP Plus Measure Set with the Adult Universal Foundation
Measure Set a
Qualit~ #
Identification Number
and Name
Domain
l\leasure Title
i,
Performance
Period Measure
Added to the
APP Plus
l\lcasurc Set
158 (varies by program):
Consumer Assessment of
321
Healthcare Providers and (:ARPS for MIPS
Person-centered care
2025
Systems overall rating
measures
561 or 44: Plan all-cause Hospital-Wide, 30-day, All-Cause
Seamless care
479
eadmissions or all-cause Unplanned Readmission (HWR) Rate for
2025
coordination
MIPS Eligible Clinician Groups
hospital readmissions
204: Hemoglobin Ale
Diabetes: Hemoglobin A 1c (HbA 1c)
001
Chronic conditions
2025
poor control (>9%)
Poor Control
672: Screening for
Preventive Care and Screening:
134
depression and follow-up Screening for Depression and Follow-up Behavioral health
2025
Plan
olan
167: Controlling high
236
Controlling High Blood Pressure
Chronic conditions
2025
blood pressure
93: Breast cancer
Wellness and
112
Breast Cancer Screening
2025
screening
prevention
139: Colorectal cancer
Wellness and
113
Colorectal Cancer Screening
2025
screening
prevention
394: Initiation and
OCnitiation and Engagement of Substance
Behavioral health
2026
305
engagement of substance
Use Disorder Treatment
use disorder treatment
Identification number
undetermined: Screening
Equity
2028
487
Screening for Social Drivers of Health
for social drivers of
nealth
26: Adult immunization
Wellness and
493
~dult Immunization Status
2028
prevention
status
a 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/fall/10.1056/NEJMp22l5539. Domains are from Meaningful Measures 2.0. Identification
numbers are CMS Measures Inventory Tool measure family identification numbers; names reflect the descriptions
associated with those numbers.
b Domains are from Meaningful Measures 2.0. Identification numbers are CMS Measures Inventory Tool measure
family identification numbers; names reflect the descriptions associated with those numbers.
VerDate Sep<11>2014
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and the CY 2028 performance period
and subsequent performance periods are
displayed in Tables 55, 56, and 57,
respectively. Under our proposal, there
would be eight measures in the APP
Plus quality measure set in the CY 2025
performance period (Table 55), nine
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measures in the CY 2026 and 2027
performance periods (Table 56), and
eleven measures in the CY 2028 and
subsequent performance periods (Table
57). We refer readers to Appendix 1 of
this proposed rule for additional
measure specification information.
E:\FR\FM\31JYP2.SGM
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EP31JY24.086
lotter on DSK11XQN23PROD with PROPOSALS2
We refer readers to Table 53 for the
APP quality measure set for the CY 2025
performance period/2027 MIPS
payment year and subsequent years. The
proposed APP Plus quality measures for
the CY 2025 performance period, the CY
2026 and 2027 performance periods,
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
TABLE 55 APPPI
Qualit~ #
Measure Title
Q
r
s
M
Collection T~ pe
i
h CY 2025 P rl
Submitter T~pe
I
321
CAHPS for MIPS
001
Diabetes:
Hemoglobin
Ale (HbAlc) Poor
Control
134
Preventive Care and
Screening:
Screening for
Depression and
Fo11ow-up Plan
236
Controlling High
Illood Pressure
479
lotter on DSK11XQN23PROD with PROPOSALS2
484
Hospital-Wide, 30day, All-Cause
Unplanned
Readmission
(HWR) Rate for
MIPS Eligible
MIPS
Clinician Groups
Clinician and
Clinician Group
Risk-standardized
Hospital Admission
Rates for Patients
with Multiple
Chronic Conditions
113
Colorectal Cancer
Screening
112
Breast Cancer
Screening
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I
p
• d
Meaningful
Measures 2.0
Area
Measure T~pe
Patient's
Experience
Patient
Engagement/
Experience
Mgt. of Chronic
Conditions
Intermediate
Outcome
Treatment of
Mental Health
Process
Mgt. of Chronic
Conditions
Intermediate
Outcome
CAHPS for MIPS
Survey
Third Party Intermediary
eCQM/MIPS CQM/Part
B Claims (all APP
reporters)
Medicare CQM (SSP
ACOs only)
eCQM/MIPS CQM/Part
B Claims (a11 APP
reporters)
Medicare CQM (SSP
ACOs only)
eCQM/MIPS CQM/Part
B Claims (all APP
reporters)
Medicare CQM (SSP
ACOs only)
MIPS Eligible Clinician
Representative of a
Practice
APMEntity
Third Partv Intermediary
MIPS Eligible Clinician
Representative of a
Practice
APM Entity
Third Party Intermediarv
MIPS Eligible Clinician
Representative of a
Practice
APMEntity
Third Party Intermediary
Administrative Claims
NIA
Admissions &
Readmissions
Outcome
Administrative Claims
NIA
Admissions &
Readmissions
Outcome
cCQM/MIPS CQM/Part
B Claims (all APP
reporters)
Medicare CQM (SSP
ACOs only)
eCQM/MIPS CQM/Part
B Claims (a11 APP
reporters)
Medicare CQM (SSP
ACOs only)
MIPS Eligible Clinician
Representative of a
Practice
APMEntity
Third Party Intermediary
MIPS Eligible Clinician
Representative of a
Practice
APMEntity
Third Party Intermediarv
Wellness and
Prevention
Process
We11ness and
Prevention
Process
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31JYP2
EP31JY24.087
62028
62029
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
Qualit) #
Q
l\lcasurc Title
I
CAHPS for MIPS
001
Diabetes:
Hemoglobin
Ale (HbAlc) Poor
Control
134
Preventive Care and
Screening:
Screening for
Depression and
Follow-up Plan
236
Controlling High
Blood Pressure
lotter on DSK11XQN23PROD with PROPOSALS2
484
Hospital-Wide, 30day, All-Cause
Unplanned
Readmission
(HWR) Rate for
MIPS Eligible
MIPS
Clinician Groups
Clinician and
Clinician Group
Risk-standardized
Hospital Admission
Rates for Patients
with Multiple
Chronic Conditions
113
Colorectal Cancer
Screening
112
Breast Cancer
Screening
305
Initiation and
Engagement of
Substance Use
Disorder Treatment
VerDate Sep<11>2014
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S fi
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h CY 2026
Collection T) pc
I
321
479
r
p
d 2027 P rfi
Submitter T) pc
I
l\lcaningful
l\lcasurcs 2.0
Arca
• d
l\lcasurc T) pc
I
Patient's
Experience
Patient
Engagement/
Experience
Mgt. of Chronic
Conditions
Intermediate
Outcome
Treatment of
Mental Health
Process
Mgt. of Chronic
Conditions
Intermediate
Outcome
N/A
Admissions &
Readmissions
Outcome
Administrative Claims
N/A
Admissions &
Readmissions
Outcome
eCQM/MTPS
CQM/Part B Claims
(all APP reporters)
Medicare CQM (SSP
ACOs only)
eCQM/MIPS
CQM/Part B Claims
(all APP reporters)
Medicare CQM (SSP
ACOs only)
MIPS Eligible Clinician
Representative of a
Practice
APMEntity
Third Party Intermediarv
MIPS Eligible Clinician
Representative of a
Practice
APMEntity
Third Party Intermediarv
MIPS Eligible Clinician
Representative of a
Practice
APM Entity
Third Party Intcrmcdiarv
Wellness and
Prevention
Process
Wellness and
Prevention
Process
Behavioral
health
Process
CAHPS for MIPS
Survey
Third Party Intermediary
eCQM/MIPS
CQM/Part B Claims
(all APP reporters)
Medicare CQM (SSP
ACOs only)
eCQM/MIPS
CQM/Part B Claims
(all APP reporters)
Medicare CQM (SSP
ACOs onlv)
eCQM/MIPS
CQM/Part B Claims
(all APP reporters)
Medicare CQM (SSP
ACOs only)
MIPS Eligible Clinician
Representative of a
Practice
APM Entity
Third Partv lntermediarv
MIPS Eligible Clinician
Representative of a
Practice
APMEntity
Third Partv Intermediarv
MIPS Eligible Clinician
Representative of a
Practice
APM Entity
Third Party Intermediary
Administrative Claims
eCQM (all APP
reporters)
Medicare CQM (SSP
ACOsonly)
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Sfmt 4725
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31JYP2
EP31JY24.088
TABLE 56 APP Pl
62030
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
TABLE 57: APP Plus Quality Measure Set for the CY2028 Performance Period and
l\k,P,un•Tirk
()ualit~ #
I
tP ti
Cnlll'rfinn T\ 1w
P •d
I
CAHPS for MIPS
001
Diabetes:
Hemoglobin
Ale (HbAlc) Poor
Control
134
Preventive Care and
Screening:
Screening for
Depression and
Follow-up Plan
236
Controlling High
Blood Pressure
484
lotter on DSK11XQN23PROD with PROPOSALS2
I
321
479
Hospital-Wide, 30day, All-Cause
Unplanned
Readmission
(HWR) Rate for
MIPS Eligible
MIPS
Clinician Grouos
Clinician and
Clinician Group
Risk-standardized
Hospital Admission
Rates for Patients
with Multiple
Chronic Conditions
Mgt. of Chronic
Conditions
Intermediate
Outcome
Treatment of
Mental Health
Process
Mgt. of Chronic
Conditions
Intermediate
Outcome
NIA
Admissions &
Readmissions
Outcome
Administrative Claims
NIA
Admissions &
Readmissions
Outcome
eCQMIMIPS
CQM/Part B Claims
(all APP reporters)
Medicare CQM (SSP
ACOsonly)
eCQM/MIPS
CQM/Part B Claims
(all APP reporters)
Medicare CQM (SSP
ACOsonly)
MIPS Eligible Clinician
Representative of a
Practice
APMEntity
Third Party Intermediary
MIPS Eligible Clinician
Representative of a
Practice
APM Entity
Third Party Intermediary
MIPS Eligible Clinician
Representative of a
Practice
APM Entity
Third Partv Intermediary
MWS Eligible Clinician
Representative of a
Practice
APMEntity
Third Partv Intermediarv
MIPS Eligible Clinician
Representative of a
Practice
APM Entity
Third Party lntermediarv
Wellness and
Prevention
Process
Wellness and
Prevention
Process
Behavioral
health
Process
Equity
Process
Wellness and
Prevention
Process
eCQMIMIPS
CQM/Part B Claims
(all APP reporters)
Medicare CQM (SSP
ACOsonly)
eCQM/MlPS
CQM/Part D Claims
(all APP reporters)
Medicare CQM (SSP
ACOsonly)
eCQM/MIPS
CQM/Part B Claims
(all APP reporters)
Medicare CQM (SSP
ACOsonlv)
MIPS Eligible Clinician
Representative of a
Practice
APM Entity
Third Partv Intermediarv
MIPS Eligible Clinician
Representative of a
Practice
APM Entity
Third Party Intermediary
MIPS Eligible Clinician
Representative of a
Practice
APM Entity
Third Partv lntermediarv
Administrative Claims
112
Breast Cancer
Screening
305
Initiation and
Engagement of
Substance Use
Disorder Treatment
eCQM (all APP
reporters)
Medicare CQM (SSP
ACOsonly)
487
Screening for
Social Drivers of
Health
eCQM/MIPS CQM (all
APP reporters)
Medicare CQM (SSP
ACOsonly)
493
Adult Immunization
Status
eCQMIMIPS CQM (all
APP reporters)
Medicare CQM (SSP
ACOsonly)
Under our proposal, scoring for the
APP quality performance category
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I
Patient
Engagement!
Experience
Third Party Intermediary
Colorectal Cancer
Screening
20:32 Jul 30, 2024
l\lea,ure
I~ pe
Patient's
Experience
CARPS for MIPS
Survey
113
BILLING CODE C
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J.rea
Suhmirkr T,1w
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scoring methodology at § 414.1367(c)(1)
would continue to be performed in
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Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
accordance with § 414.1380(b)(1). For
the APP quality measure set, this means
that the scoring methodology would not
change. For the APP Plus quality
measure set, we are proposing to
calculate the MIPS quality performance
category score for a MIPS eligible
clinician, group, or APM Entity that
chooses to report the APP Plus quality
measure set via the APP by summing
the scores for all of the measures, as
applicable, included in the APP Plus
quality measure set for a given year.
Scoring clinicians on all measures, as
applicable, in the APP Plus quality
measure set will promote the best,
safest, and most equitable care and
provide a comprehensive assessment of
the performance of those who choose to
report the measure set.
Because we are proposing that a MIPS
eligible clinician, group, or APM Entity
that chooses to report the APP Plus
quality measure set would be scored on
all of the measures in that set, we are
also proposing a conforming change to
MIPS data submission requirements in
§ 414.1335(b) to require that a MIPS
eligible clinician, group, or APM Entity
that reports the APP Plus quality
measure set via the APP would be
required to report on all measures
included in the APP Plus quality
measure set, except for administrative
claims-based measures, which are
calculated using data from claims
submissions. We solicit comment on
this proposal. For further discussion on
the data submission proposal for the
APP Plus quality measure set, see
section IV.A.4.e.(1)(b) of this proposed
rule.
lotter on DSK11XQN23PROD with PROPOSALS2
d. Data Submission for the Performance
Categories
(1) Overview
For previously established policies
relevant to data submission for the MIPS
performance categories, we refer readers
to § 414.1325 and the CY 2017 Quality
Payment Program final rule (81 FR
77087 through 77097), CY 2018 Quality
Payment Program final rule (82 FR
53619 through 53626), CY 2023 PFS
final rule (86 FR 65438 through 65441)
and CY 2024 PFS final rule (88 FR
79330 through 79332). Specifically, we
finalized at § 414.1325(a)(1) that
individual MIPS eligible clinicians,
groups, virtual groups, subgroups, and
Advanced Payment Model (APM)
Entities must submit data on measures
and activities for the quality,
improvement activities, and Promoting
Interoperability performance categories
in accordance with § 414.1325. We note,
that under the current policies
described at § 414.1325(a)(2), there are
VerDate Sep<11>2014
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Jkt 262001
no data submission requirements for the
cost performance category or
administrative claims-based quality
measures.
In this section, we are proposing to
adopt minimum criteria for a qualifying
data submission for a MIPS performance
period for the quality, improvement
activities, and Promoting
Interoperability performance categories,
which we propose to codify at
§ 414.1325(a)(1)(i) through (iii). We are
also proposing to codify our existing
policies governing our treatment of
multiple data submissions received for
the quality and improvement activities
performance categories at
§ 414.1325(f)(1). We are also proposing
to modify our policy governing our
treatment of multiple data submissions
received for the Promoting
Interoperability performance category,
which we propose to codify at
§ 414.1325(f)(2).
Proposals in this section of this
proposed rule are intended to eliminate
certain issues with the scoring of an
unintended data submission affecting
payment adjustments for individual
MIPS eligible clinicians, groups, virtual
groups, subgroups, and APM Entities.
We are proposing these changes to be
effective beginning with the CY 2024
performance period/2026 MIPS
payment year for the data submission
period in CY 2025. Additionally, we
refer readers to section V.B.8.e. of this
proposed rule for discussion on the
burden estimates for these proposals.
(2) Proposed Minimum Criteria for a
Qualifying Data Submission for the
MIPS Quality, Improvement Activities,
and Promoting Interoperability
Performance Categories
(a) Background
CMS uses the data submitted by (or
on behalf of) individual MIPS eligible
clinicians, groups, virtual groups,
subgroups, or APM Entities in the
quality, improvement activities, and
Promoting Interoperability performance
categories to assess their performance
on the measures and activities in these
three categories and to determine their
MIPS payment adjustments. Under the
previously established data submission
policies at § 414.1325, individual MIPS
eligible clinicians, groups, virtual
groups, subgroups, and APM Entities
generally submit data on measures and
activities for the quality, improvement
activities, and Promoting
Interoperability performance categories
in accordance with the data submission
deadlines at § 414.1325(e)(1). Currently,
we consider any submission of data
received for a MIPS performance
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62031
category during the designated data
submission period for a MIPS
performance period in accordance with
§ 414.1325(e)(1) to be a data submission
for the corresponding MIPS
performance period and assign a score
for the submission.
For the quality and improvement
activities performance categories, under
the current reweighting policies at
§ 414.1380(c)(2)(i)(A)(6) through (8) for
an extreme and uncontrollable
circumstance (EUC) or other type of
exception based on certain
circumstances, we score any data
submitted by (or on behalf of) a MIPS
eligible clinician with an approved
reweighting application. This includes
MIPS eligible clinicians with an
approved application-based EUC
reweighting or an approved reweighting
for a clinician identified in a CMSdesignated region affected by an
automatic EUC event. Under this
current policy, in the event that a MIPS
eligible clinician submits any data for
the quality or improvement activities
performance category, such submission
overrides the approved reweighting for
the applicable performance category and
we will score the performance
categories for which data was
submitted, and include the performance
category scores in the MIPS eligible
clinician’s final score as otherwise
provided in § 414.1380(c).
Similarly, for the Promoting
Interoperability performance category,
under the current reweighting policies
at § 414.1380(c)(2)(i)(C) for a significant
hardship or other type of exception
based on certain circumstances, we
score any data submitted by (or on
behalf of) a MIPS eligible clinician with
an approved reweighting application,
except as provided in
§ 414.1380(c)(2)(i)(C)(10) and (11).
Under this current policy, in the event
that a MIPS eligible clinician submits
any data for the Promoting
Interoperability performance category,
such submission overrides the approved
reweighting for the performance
category and we will score the
Promoting Interoperability performance
category and include the category score
in the MIPS eligible clinician’s final
score as otherwise provided in
§ 414.1380(c).
We have received inquiries from
MIPS eligible clinicians that highlight
unintended consequences associated
with our current data submission
requirements. Several MIPS eligible
clinicians have notified us that there
have been instances where they
unintentionally submitted non-scorable
data for a MIPS performance category,
which overrode an approved
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Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
reweighting or a previously scorable
data submission for the MIPS quality,
improvement activities, or Promoting
Interoperability performance categories.
Data submissions without any scorable
data (non-scorable data submissions)
generally only include limited data that
cannot be scored such as a practice ID,
date, activity ID, measure ID, or CMS
Electronic Health Record (EHR)
Certification ID (CEHRT ID). MIPS
eligible clinicians have also notified us
that, in some instances, the data
submission overriding the prior
approved reweighting or prior scorable
submission was performed by a third
party intermediary or a practice
representative.
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, APM
Entity, as applicable, that submits data
on measures and activities under MIPS
is defined at § 414.1305 as the submitter
type.
The mechanism by which a submitter
type submits data to CMS (including, as
applicable: Direct, log in and upload,
log in and attest, Medicare Part B
claims, and the CMS Web Interface) is
defined at § 414.1305 as the submission
type. The direct submission type allows
users to transmit data through a
computer-to-computer interaction, such
as an API. The log in and upload
submission type allows users to upload
and submit data in the form and manner
specified by CMS with a set of
authenticated credentials. The log in
and attest submission type allows users
to manually attest that certain measures
and activities were performed in the
form and manner specified by CMS with
a set of authenticated credentials. We
refer readers to § 414.1325(b) and (c) for
available data submission types
individual MIPS eligible clinicians,
groups, virtual groups, subgroups, and
APM Entities may utilize to submit data
for the quality, improvement activities,
and Promoting Interoperability
performance categories.
To submit data, a submitter must gain
access to the Quality Payment Program
website (https://qpp.cms.gov/login) for
submitting or viewing data for the
associated individual MIPS eligible
clinician, group, subgroup, virtual
group, or APM Entity. We refer readers
to the Quality Payment Program
Resource Library (https://qpp-cm-prodcontent.s3.amazonaws.com/uploads/
335/QPP%20Access%20
User%20Guide.zip) for additional
information on the MIPS data
submission process and obtaining
access to submit data during the
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designated submission period under
§ 414.1325(e)(1).
After gaining access to the Quality
Payment Program website for the
associated individual MIPS eligible
clinician, group, subgroup, virtual
group, or APM entity, a submitter can
navigate to the ‘‘Eligibility and
Reporting’’ tab and view whether there
is any reweighting applied for one or
more of the MIPS performance
categories for the associated individual
MIPS eligible clinician, group, virtual
group, subgroup, or APM Entity. In
addition, at the time of submission, the
system generates warnings to the
submitter (for all the available
submission types) if there is an existing
approved reweighting for the
performance category in which the data
is being submitted or an existing data
submission for an individual MIPS
eligible clinician, group, virtual group,
subgroup, or APM Entity. For example,
if a group has an approved reweighting
for the Promoting Interoperability
performance category, the system alerts
the submitter prior to completing the
data submission with a message stating:
‘‘This Action Will Impact Your Category
Weights. Currently, Promoting
Interoperability does not count towards
your final score. By choosing to report
Promoting Interoperability data, your
score for this category will be included
in your final score. This action cannot
be undone.’’ The submitter must check
the ‘‘Yes, I agree’’ box prior to
confirming the data submission in the
performance category. We refer readers
to the Quality Payment Program
Resource Library (https://qpp.cms.gov/
resources/resource-library) for
additional details on the process to
submit MIPS data for MIPS eligible
clinicians, groups, virtual groups,
subgroups, and APM Entities.
Under the current process, we assign
a score for any submission received
from an individual MIPS eligible
clinician, group, virtual group, subgroup
or APM Entity for a performance period
during the designated MIPS submission
period regardless of whether the
submission included data on the MIPS
measures and activities. We
implemented the process to recognize
any data submitted as an extension of
the policy that submission of any data
overrides reweighting of the MIPS
performance categories as described at
§ 414.1380(c)(2). We assign a score for
submissions with data on MIPS
measures and activities, and also for
submissions that only include nonscorable data, such that they do not
include any data that allows us to
measure a clinician’s performance on
the applicable measures and activities.
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For example, if we receive a submission
for a MIPS performance category
without any measure or activity data
(for example, without numerator and
denominator data for any quality
measures, without a response of ‘‘yes’’
for any improvement activities, without
a ‘‘yes’’ or ‘‘no’’ response for an
attestation, or responses for the required
objectives and associated measures and
attestation statements for the Promoting
Interoperability performance category),
and the data submission includes only
non-scorable data (such as the practice
ID, measure ID and TIN/NPI
information), we assign a zero score for
the applicable MIPS performance
category in the event we do not receive
a subsequent submission with measure
or activity data.
Despite implementing these system
warnings to alert the submitter of a
potential impact of their entry on the
reweighting status or existing data
submission, we continue to receive nonscorable data submissions, which
override an approved reweighting, or a
previously scored data submission, for
the MIPS quality, improvement
activities, or Promoting Interoperability
performance categories. To help address
the unintentional overriding of an
existing scorable data submission or an
approved reweighting for the MIPS
performance categories, we are
proposing a narrower set of minimum
criteria of what would qualify as a data
submission under our existing policies.
We note that we are not proposing to
change our existing policies to assign a
score for a data submission (meeting the
proposed narrower minimum criteria)
for the applicable MIPS performance
categories, including our policy
governing data submissions from a third
party intermediary, even if the
submission overrides an approved
reweighting or a prior scorable
submission for the MIPS eligible
clinician, group, virtual group,
subgroup, or APM Entity.
We have identified that we could
potentially avoid submissions without
any scorable data on MIPS measures or
activities from overriding previously
approved reweighting or a prior
submission for the MIPS performance
categories if we require a submission to
include certain data on measures or
activities in the MIPS quality,
improvement activities, or Promoting
Interoperability performance categories
in order to assign a score. Therefore, we
are proposing to adopt minimum
criteria for what we would consider to
be a qualifying data submission for
which CMS can assign a score.
Specifically, we are proposing to
consider a submission valid and
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scorable (including, potentially, a score
of zero) for the applicable MIPS
performance category only if the data
submission includes: numerator and
denominator data for at least one MIPS
quality measure in the quality
performance category; a response of
‘‘yes’’ for at least one improvement
activity in the improvement activities
performance category; and all required
elements to report objectives and
associated measures and attestation
statements for the Promoting
Interoperability performance
category.737 We discuss the details of
these proposed data submission criteria
for each performance category in
sections IV.A.4.d.(2)(b), IV.A.4.d.(2)(c),
and IV.A.4.d.(2)(d) of this proposed
rule.
We note that we are not proposing
any changes to the existing scoring or
reweighting policies described under
§ 414.1380 for the MIPS performance
categories in this section of this
proposed rule. If the MIPS eligible
clinician, group, virtual group,
subgroup, or APM Entity does not have
an approved reweighting for one or
more of the MIPS performance
categories and we do not receive a data
submission for a performance category
that has not been reweighted, we will
assign a score of zero for the applicable
performance category.
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(b) Quality Performance Category
We refer readers to §§ 414.1325 and
414.1330 through 414.1340 and the CY
2017 Quality Payment program final
rule (81 FR 77097 through 77162) and
CY 2018 Quality Payment Program final
rule (82 FR 53626 through 53641), the
CY 2019 PFS final rule (83 FR 59754
through 59765), CY 2020 PFS final rule
(84 FR 63949 through 62959), CY 2021
PFS final rule (85 FR 84866 through
84877), CY 2022 PFS final rule (86 FR
65431 through 65445), CY 2023 PFS
final rule (87 FR 70047 through 70057),
and CY 2024 PFS final rule (88 FR
79329 through 79338) for a description
of previously established policies
related to the quality performance
category. The data submitted from the
final list of MIPS quality measures are
used to assess the performance of an
individual MIPS eligible clinician,
737 Attestation is one possible way to for MIPS
eligible clinicians participating in APMs to earn
credit in the improvement activities performance
category but is not required to earn credit.
Consistent with our regulation at § 414.1380(b)(3)(i),
we automatically award 50 percent credit for the
improvement activities performance category to
MIPS eligible clinicians participating in APMs
when they attest to having completed an
improvement activity or submit data for the quality
or Promoting Interoperability performance
categories. We are not proposing to change this.
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group, virtual group, subgroup, or APM
Entity for the quality performance
category, to contribute to their overall
score, and to help determine the
payment adjustment for MIPS eligible
clinicians.
We are proposing that a data
submission in the quality performance
category must include numerator and
denominator data for at least one quality
measure from the list of MIPS quality
measures to be assigned a score in the
quality performance category. Under the
current policies described at § 414.1325,
we finalized data submission types for
MIPS eligible clinicians, groups, virtual
groups, subgroups, and APM Entities. In
the CY 2018 Quality Payment Program
final rule (82 FR 53780), we stated that
we will determine a quality
performance category percent score
whenever a MIPS eligible clinician has
submitted at least one quality measure.
As described previously in this section
of this proposed rule, we currently
assign a score for any data submitted for
the MIPS performance categories and
have implemented operational measures
to limit unintentional overriding of an
approved reweighting or existing
scorable data submitted for a MIPS
performance category. However, we
continue to receive unintentional
submissions without data that can be
scored resulting in the overriding of an
approved reweighting application or a
prior data submission that can be scored
for the quality performance category.
We note that this proposal does not
include any changes to the current
scoring policies described under
§ 414.1380(b)(1) for the quality
performance category. Therefore, we
will still assign a score of zero for the
quality performance category if an
individual MIPS eligible clinician,
group, virtual group, subgroup, or APM
Entity does not submit at least one
available quality measure unless the
performance category has been
reweighted as defined at
§ 414.1380(c)(2).
We propose to specify what we
consider to be a data submission at
§ 414.1325(a)(1)(i) to state that, for the
quality performance category, a data
submission must include numerator and
denominator data for at least one MIPS
quality measure from the final list of
MIPS quality measures. We anticipate
the proposed change would potentially
avoid unintentional overriding of an
approved reweighting or a prior data
submission for the quality performance
category due to submissions without
any quality measure data. We are not
proposing any changes to the data
submission requirements, data
submission criteria, data completeness
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62033
criteria, and scoring for the quality
performance category described under
§§ 414.1325, 414.1335, 414.1440, and
414.1380(b)(1) respectively. We request
public comments on this proposal.
(c) Improvement Activities Performance
Category
We refer readers to §§ 414.1355 and
414.1360 and the CY 2017 Quality
Payment Program final rule (81 FR
77177 and 77178), CY 2018 Quality
Payment Program final rule (82 FR
53648 through 53661), CY 2019 PFS
final rule (83 FR 59776 and 59777), CY
2020 PFS final rule (84 FR 62980
through 62990), CY 2022 PFS final rule
(86 FR 65462) and the CY 2024 PFS
final rule (88 FR 79328) for a
description of previously established
policies related to the improvement
activities performance category.
We previously finalized at
§ 414.1360(a)(2) that MIPS eligible
clinicians, groups, virtual groups, or
subgroups must submit a yes response
for each improvement activity that is
performed for at least a continuous 90day period during the applicable
performance period to receive points in
the improvement activities performance
category described under
§ 414.1360(b)(3). We currently assign a
score for any submission or attestation
received in the improvement activities
performance category via the
submission types described under
§ 414.1325(a)(1) regardless of whether
the submission or attestation included a
yes response or not. In the event of a
submission without yes responses, we
currently assign a score of zero.
Data submitted in the improvement
activities performance category is used
to assess the performance of an
individual MIPS eligible clinician,
group, virtual group, subgroup, or APM
Entity on the attestation or data
submission for the improvement
activities and to determine the payment
adjustment for MIPS eligible clinicians.
We are proposing to specify for
clinicians what we consider to be a data
submission and that we would score a
data submission only if the submission
includes a response of ‘‘yes’’ for at least
one improvement activity included in
the improvement activities inventory for
the MIPS performance period. We
anticipate the proposed change would
potentially avoid unintentional
overriding of an approved reweighting
or a prior data submission for the
improvement activities performance
category due to submissions or
attestations without a response of ‘‘yes’’
for any of the improvement activities.
We propose to specify what we
consider to be a data submission at
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§ 414.1325(a)(1)(ii) to state that for the
improvement activities performance
category, a data submission must
include a response of ‘‘yes’’ for at least
one activity in the MIPS improvement
activities inventory. We note that we are
not proposing any changes to the data
submission criteria and scoring for the
improvement activities performance
category described under §§ 414.1360
and 414.1380(b)(3) respectively. We
request public comments on this
proposal.
(d) Promoting Interoperability
Performance Category
We refer readers to § 414.1375 for our
previously established policies
regarding reporting for the Promoting
Interoperability performance category.
We also refer readers to § 414.1305 for
the definition of attestation, § 414.1325
for data submission requirements, and
§ 414.1380(b)(4) for Promoting
Interoperability performance category
scoring. We refer readers to
§ 414.1380(c)(2)(i)(C) for our previously
finalized policies regarding scoring of
data submission in the Promoting
Interoperability performance category
after an approved reweighting for the
performance category. We also refer
readers to 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, CY 2021, CY 2022, CY
2023, and CY 2024 PFS final rules (83
FR 59785 through 59820, 84 FR 62991
through 63006, 85 FR 84886 through
84895, 86 FR 65466 through 65490, 87
FR 70060 through 70087, and 88 FR
79351 through 79365, respectively) for a
description of previously established
policies related to the Promoting
Interoperability performance category.
We currently consider any
information received for the Promoting
Interoperability performance category in
the Quality Payment Program
Submission environment a data
submission and assign a performance
category score based on the submission.
We assign a score of zero for incomplete
submissions in the Promoting
Interoperability performance category,
for example, submissions that include
only a date and CMS CEHRT ID without
any data that can be scored with respect
to the required objectives, measures, or
attestations, as specified by CMS. Under
§ 414.1375, if we receive a complete
data submission for the Promoting
Interoperability performance category
with responses included for all the
required Promoting Interoperability
objectives, associated measures, and
attestation statements as specified by
CMS and utilizing the CEHRT (meeting
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the definition at § 414.1305) as required,
we score the data submission under our
established scoring policies for the
performance category.
We previously finalized at
§ 414.1380(c)(2)(i)(C) that, if a MIPS
eligible clinician with an approved
reweighting for the Promoting
Interoperability performance category
submits data, they will be scored in this
performance category and the
reweighting will not be applied, except
as provided in § 414.1380(c)(2)(i)(C)(10)
and (11). We also included in the
educational materials available on the
Quality Payment Program resource
library (https://qpp-cm-prod
content.s3.amazonaws.com/uploads/
2602/2023MIPSSubmissionGuide.pdf)
that a MIPS eligible clinician will be
scored in this performance category if
they attest to any data, such as selecting
performance period dates or responding
to attestation statements during the
submission period. As set forth under
§ 414.1380(c)(2)(i)(C), submission of any
data for the Promoting Interoperability
performance category overrides
reweighting, including reweighting due
an approved significant hardship
exception and automatic reweighting for
clinicians that are Ambulatory Surgical
Center (ASC)-based, hospital-based,
non-patient facing, and small practices.
Similarly, under
§ 414.1380(c)(2)(i)(A)(4)(iii), submission
of any data also overrides our automatic
reweighting of the Promoting
Interoperability performance category
for clinical social workers.738
Furthermore, to earn a performance
category score for the Promoting
Interoperability performance category,
we established at § 414.1375 that, for the
performance period established at
§ 414.1320, individual MIPS eligible
clinicians, groups, virtual groups,
subgroups, or APM Entities must use
CEHRT as defined at § 414.1305, report
on objectives and associated measures
as specified by CMS, and submit
attestations as specified by CMS. Under
§ 414.1325(b) and (c), individual MIPS
eligible clinicians, groups, virtual
groups, subgroups and APM entities (or
authorized representatives submitting
on their behalf) can submit data for the
Promoting Interoperability performance
category using the direct, login and
attest, or login and upload submission
types. Specifically, to submit data for
the Promoting Interoperability
performance category, individual MIPS
eligible clinicians, groups, virtual
738 We note that this automatic reweighting policy
for clinical social workers only applies through the
CY 2024 performance period/2026 MIPS payment
year.
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groups, subgroups and APM entities (or
authorized representatives submitting
on their behalf) must use CEHRT as
required (meeting the definition at
§ 414.1305) for the continuous 180-day
performance period (§ 414.1320(i)) to
report the applicable objectives,
measures, and attestations. We refer
readers to section IV.A.4.e.(4) of this
proposed rule for additional details on
CEHRT requirements (including ONC
health IT certification criteria set forth
under 45 CFR 170.315) and objectives,
measures, and attestations required for
the Promoting Interoperability
performance category.
Currently, we receive submissions in
the Promoting Interoperability
performance category without
completed responses for all the required
objectives, measures, and attestations.
For example, if a submission for the
Promoting Interoperability performance
category includes only a date, practice
ID, and/or a CEHRT ID, or the
submission does not include all of the
required objectives, measures, and
attestations, then we consider these to
be incomplete data submissions.
Currently, an incomplete data
submission would void an approved
reweighting of the Promoting
Interoperability performance category in
accordance with § 414.1380(c)(2)(i)(C).
As discussed in this section of this
proposed rule, we believe that we
should not consider data submissions
for the Promoting Interoperability
performance category if the submission
is incomplete, and does not include all
necessary required data. We are
proposing that the minimum criteria for
a qualifying data submission for the
Promoting Interoperability performance
category must include all required
reporting elements for the performance
category, as specified below.
We considered whether CMS should
accept incomplete submissions for the
Promoting Interoperability performance
category. If CEHRT is utilized as
required to collect and report measure
data and submit attestation statements
and other requirements, it would
generally result in only complete
submissions for the Promoting
Interoperability performance category.
We recognize that some of the measures
in the Promoting Interoperability
performance category (such as the
SAFER Guides measure and security
risk analysis) do not directly require the
use of CEHRT, whereas some measures
(such as e-prescribing) directly require
the use of CEHRT. However, all the
requirements for the Promoting
Interoperability performance category
are directly related to a MIPS eligible
clinician demonstrating that whether
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they are a meaningful user of CEHRT in
accordance with sections
1848(q)(2)(A)(iv), (B)(iv) and
1848(o)(2)(A) of the Act. Further,
section 1848(o)(2)(A) requires that all
requirements set forth therein
(meaningful use of CEHRT, electronic
exchange of health information, and
reporting on clinical quality and other
measures using CEHRT) be met for a
MIPS eligible clinician to be treated as
a meaningful EHR user for the
applicable performance period.
Therefore, accepting an incomplete data
submission for the Promoting
Interoperability performance category
would be counterintuitive to a MIPS
eligible clinician demonstrating whether
they are a meaningful user of CEHRT in
accordance with sections
1848(q)(2)(A)(iv), (B)(iv) and
1848(o)(2)(A) of the Act.
We are proposing to adopt minimum
criteria for what we would consider a
qualifying data submission for the
Promoting Interoperability performance
category only if the submission includes
all of the required reporting elements for
the category, including data on all
required measures (including any claim
of an applicable exclusion), required
attestation statements, the CEHRT ID,
and the start and end date for the
applicable performance period. This
proposal would clarify what counts as a
data submission for MIPS eligible
clinicians and it would potentially
avoid partial data submissions from
overriding an approved reweighting or a
previously scored submission for the
Promoting Interoperability performance
category.
Specifically, we propose to specify
minimum criteria as a qualifying data
submission for the Promoting
Interoperability performance category at
§ 414.1325(a)(1)(iii) to provide that a
data submission must include all of the
following elements:
• Performance data, including any
claim of an applicable exclusion, for the
measures in each objective, as specified
by CMS;
• Required attestation statements, as
specified by CMS;
• CMS EHR Certification ID (CEHRT
ID) from the Certified Health IT Product
List (CHPL); and
• The start date and end date for the
applicable performance period as set
forth in § 414.1320.
As discussed previously, we are not
proposing any changes to the existing
scoring or reweighting policies
described under § 414.1380 for the MIPS
performance categories in this section of
this proposed rule. If the MIPS eligible
clinician, group, virtual group,
subgroup, or APM Entity does not have
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an approved reweighting for one or
more of the MIPS performance
categories and we do not receive a data
submission meeting the proposed
minimum criteria for a performance
category that has not been reweighted,
we will assign a score of zero for the
applicable performance category. If we
receive a qualifying data submission
meeting the proposed minimum criteria
for reporting, then we will review the
data submission and score the
Promoting Interoperability performance
category in accordance with our
applicable scoring policies.
We refer readers to section
IV.A.4.e.(4) of this proposed rule for
additional details on the reporting
requirements and scoring of the
objectives, measures, and attestations
the Promoting Interoperability
performance category.
We request public comments on this
proposal.
(3) Treatment of Multiple Data
Submissions
(a) Background
Under the current policies described
at § 414.1325(d), individual MIPS
eligible clinicians, groups, virtual
groups, subgroups, and APM Entities
may submit their MIPS data using
multiple data submission types for any
performance category in accordance
with § 414.1325(a)(1), as applicable;
provided, however, that the individual
MIPS eligible clinician, group, virtual
group, subgroup, or APM Entity uses the
same identifier for all performance
categories and all data submissions. We
established the policy to offer flexibility
for individual MIPS eligible clinicians,
groups, virtual groups, subgroups, and
APM Entities with reporting, as it
provides more options for submission of
data for the applicable performance
categories. We refer readers to the CY
2017 and 2018 Quality Payment
Program final rules (81 FR 77094 and
77095 and 82 FR 53619 through 53626,
respectively) for additional details on
the use of multiple data submission
mechanisms for any MIPS performance
category.
As discussed in this section of this
proposed rule, at § 414.1305, we define
a submitter type as a 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, APM Entity, as applicable,
that submits data on measures and
activities under MIPS. During a
submission period, a submitter
associated with an organization (for
example, registry, practice
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62035
administrator, or EHR vendor) could
submit data for a MIPS eligible
clinician, group, subgroup, virtual
group, or APM Entity. If needed, the
submitter could also review and correct
the data submission resulting in
multiple data submissions for the MIPS
performance categories. Additionally,
there could be instances when a
submitter unintentionally submits data
multiple times. There could also be
instances when we receive data for a
MIPS eligible clinician, group,
subgroup, virtual group, or an APM
Entity from multiple organizations. For
example, both a registry and a QCDR
could submit MIPS data on behalf of a
group practice for a performance period.
Individual MIPS eligible clinicians,
groups, practice representatives, and
third party intermediaries benefit from
the flexibility to submit data multiple
times as it provides opportunities to
correct errors in a prior submission and
allows clinicians to submit data from
multiple sources (qualified registry and
group submission) to increase their
chances to provide the most clinically
relevant data.
For the quality, improvement
activities, and Promoting
Interoperability performance categories,
there is an established policy governing
our treatment of multiple data
submissions received for a performance
period; additional guidance on how we
process and score multiple submissions
received in the MIPS performance
categories via educational and outreach
materials is available on the Quality
Payment Program Resource Library
(https://qpp.cms.gov/resources/
resource-library). However, we have not
codified this policy in prior rules. In
this section, we are proposing to codify
at § 414.1325(f)(1) our existing policies
governing our treatment of multiple data
submissions received for the quality and
improvement activities performance
categories. We are also proposing to
modify our policy governing our
treatment of multiple data submissions
received for the Promoting
Interoperability performance category,
which we also propose to codify at
§ 414.1325(f)(2).
(b) Quality and Improvement Activities
Performance Categories
In the CY 2018 Quality Payment
Program final rule (82 FR 53619 through
53626), we discussed scoring policies
for multiple submissions received in the
MIPS performance categories.
Specifically, we stated that if an
individual MIPS eligible clinician or
group submits the same measure
through two different mechanisms, each
submission would be calculated and
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scored separately and that we do not
have the ability to aggregate data on the
same measure across submission
mechanisms. We would only count the
submission that gives the clinician the
higher score, thereby avoiding double
counting (82 FR 53620). We refer
readers to CY 2019 PFS final rule (83
FR59747 through 59749) for our
discussion of previously finalized
policies related to the use of the term
‘‘submission mechanism.’’
Under the existing process for the
quality and improvement performance
categories, if we receive multiple
submissions for an individual clinician,
group, subgroup, or virtual group from
submitters from separate organizations
(for example, registry, practice
administrator, or EHR vendor), we score
each submission and assign the highest
of the scores for the performance
category. If we receive multiple
submissions for an individual clinician,
group, subgroup, or virtual group from
a submitter or submitters from the same
organization, we will use the most
recent submission. For example, if a
qualified registry submits improvement
activities for a group on Tuesday and a
practice administrator submits
improvement activities data for the
same group on Wednesday, we will
score all the data submissions and
assign the highest of the scores. If the
practice administrator from a group
practice submits improvement activities
data for the group on Tuesday and
either the practice administrator or
another submitter employed by the
group practice submits improvement
activities data for the group again on
Wednesday, we will score only the data
submission received on Wednesday
because a new data submission received
from the same organization on
Wednesday will override the prior data
submission on Tuesday.
To codify the existing process for
multiple data submissions for the
quality and improvement activities
performance categories, we are
proposing to add at § 414.1325(f)(1) that
for multiple data submissions received
in the quality and improvement
activities performance categories in
accordance with paragraphs (a)(1)(i) and
(ii) for an individual MIPS eligible
clinician, group, subgroup, or virtual
group from submitters in multiple
organizations (for example, qualified
registry, practice administrator, or EHR
vendor), CMS will calculate and score
each submission received and assign the
highest of the scores. We are also
proposing to modify our policy
governing our treatment of multiple data
submissions for the quality and
improvement activities performance
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category received for an individual
MIPS eligible clinician, group,
subgroup, or virtual group from one or
multiple submitters in the same
organization and score the most recent
submission. We request public
comments on this proposal.
(c) Promoting Interoperability
Performance Category
For the Promoting Interoperability
performance category, we explained in
the educational materials published on
the Quality Payment Program Resource
Library (https://qpp-cm-prodcontent.s3.amazonaws.com/uploads/
2602/2023MIPSSubmissionGuide.pdf)
that any data submitted through
multiple submission types or multiple
submissions submitted through the
same submission type will result in a
score of zero for the Promoting
Interoperability performance category.
Additionally, we recommended using a
single submission type (file upload, API,
or attestation by an individual MIPS
eligible clinician, group, virtual group,
subgroup or a third party intermediary)
to submit data for the Promoting
Interoperability performance category.
As discussed in section IV.A.4.d.(2)(d)
of this proposed rule, the utilization of
the CEHRT should not generate
conflicting data for measures and
objectives in the Promoting
Interoperability performance category.
However, we have received inquiries
from MIPS eligible clinicians that were
impacted by the existing process to
assign a score of zero for multiple
submissions in the Promoting
Interoperability performance category.
Specifically, we identified scenarios
when a complete submission from an
individual MIPS eligible clinician or
group followed by an incomplete
submission resulted in a score of zero,
either overriding a previous score
greater than zero or voiding an approved
reweighting for the performance
category.
On this basis, we propose to amend
our policy for treatment of multiple data
submissions for the Promoting
Interoperability performance category.
We are proposing that, for multiple data
submissions received, CMS would
calculate a score for each data
submission received and assign the
highest of the scores. We also are
proposing to codify this proposal at
§ 414.1325(f)(2).
We believe this proposal is consistent
with our existing policy for treatment of
multiple data submissions received in
the quality and improvement activities
performance categories, as discussed
previously. Implementing a similar
policy for allowing multiple data
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submissions in the Promoting
Interoperability performance category
may provide flexibility for individual
MIPS eligible clinicians, groups, virtual
groups, subgroups, and APM Entities to
fix errors in a prior data submission.
Additionally, we recognize there may be
instances when a practice switches EHR
vendors during a performance period,
potentially resulting in separate data
submissions for the Promoting
Interoperability performance category.
This proposed policy also aligns with
our intent to maintain consistency in
data submission requirements across all
MIPS performance categories, to the
extent possible, as it significantly
reduces the complexity for MIPS
eligible clinicians participating in MIPS.
We request public comments on this
proposal.
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
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, CY 2023, and
CY 2024 PFS final rules (83 FR 59754
through 59765, 84 FR 63949 through
62959, 85 FR 84866 through 84877, 86
FR 65431 through 65445, 87 FR 70047
through 70055, and 88 FR 79329
through 79338, 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:
• Establish the data submission
criteria for the Alternative Payment
Model (APM) Performance Pathway
(APP) quality measure set.
• Maintain the data completeness
criteria threshold of at least 75 percent
for the CY 2027 and CY 2028
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performance periods/2029 and 2030
MIPS payment years.
• Codify previously established
criteria pertaining to the removal of
MIPS quality measures.
• 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) Data Submission Criteria
lotter on DSK11XQN23PROD with PROPOSALS2
(i) Data Submission Criteria for the
Quality Performance Category
In the CY 2021 PFS final rule (85 FR
84859 through 84866), we established
the APP in § 414.1367 as an available
reporting option starting with the CY
2021 performance period/2023 MIPS
payment year, which was designed to
provide a predictable and consistent
MIPS reporting option to reduce
reporting burden and encourage
continued APM participation.
Additionally, we finalized a quality
measure set (85 FR 84860 through
84861) for purposes of the quality
performance category scoring for the
APP.
The APP and the APP quality measure
set were designed to reduce the
reporting burden and create new scoring
opportunities for MIPS APMs by having
a stable, streamlined pathway for
reporting and scoring in MIPS while
recognizing the reporting burden and
performance scoring that MIPS eligible
clinicians, groups, and APM Entities
already experience in their respective
MIPS APMs. We believed that using a
broadly applicable population healthbased measure set would enable MIPS
APM participants to focus on the quality
measures being reported through their
APMs, while relying on a consistent
measure set within the APP from year
to year. (85 FR 84862).
In section IV.A.4.c.(3) of this
proposed rule, we are proposing to
create a second quality measure set as
an available option under the APP,
specifically the APP Plus quality
measure set, which is a set of measures
that are included in the Adult Universal
Foundation measure set. Of the ten
Adult Universal Foundation measures,
five of the measures are already
included in the APP quality measure set
for the CY 2025 performance period/
2027 MIPS payment year (88 FR 79113
through 79114). The APP Plus quality
measure set would initially consist of all
the measures currently within the APP
quality measure set (five Adult
Universal Foundation measures and a
separate quality measure) plus two
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additional measures from the Adult
Universal Foundation measure set. The
set would incrementally add the
remaining three Adult Universal
Foundation measures by the CY 2028
performance period/2030 MIPS
payment year. (We refer readers to
section IV.A.4.c.(3) of this proposed rule
for further discussion regarding the APP
Plus quality measure set.) Aligning the
APP Plus quality measure set with the
Adult Universal Foundation measure set
serves to advance Medicare’s overall
value-based care strategy and maintain
alignment within and across CMS’s
quality programs. The alignment of
quality measures across CMS programs
allows clinicians to better focus their
quality efforts, reduce administrative
burden, and drive digital transformation
and stratification of a focused quality
measure set to assess the impact on
disparities.739
For the APP Plus quality measure set,
we are proposing in § 414.1335(b) to
require MIPS eligible clinicians, groups,
and APM Entities, including Medicare
Shared Saving Program Accountable
Care Organizations (ACOs), to report on
all measures in the APP Plus quality
measure set (with the exception of the
administrative claims-based quality
measures automatically calculated by
CMS) for the applicable performance
period. As discussed further in sections
IV.A.4.c.(3) of this proposed rule, the
APP Plus quality measure set would be
optional for MIPS eligible clinicians,
groups, and APM Entities (not including
Medicare Shared Savings Program
ACOs) meeting the reporting
requirements under the APP starting
with the CY 2025 performance period/
2027 MIPS payment year. However, for
a Medicare Shared Savings Program
ACOs, they would be required to report
the APP Plus quality measure set to
meet the reporting requirements of the
Medicare Shared Savings Program’s
quality performance standard as
discussed in section IV.A.4.c.(2) of this
proposed rule. Under the proposal in
§ 414.1335(b), the requirement to report
all measures within the APP Plus
quality measure set (with the exception
of the administrative claims-based
quality measures automatically
calculated by CMS) would be the same
regardless of whether a MIPS eligible
clinicians, group or APM Entity is
reporting the APP Plus quality measure
set on a mandatory or optional basis. We
are proposing conforming amendments
in § 414.1335(a).
739 Update On The Medicare Value-Based Care
Strategy: Alignment, Growth, Equity’’, Health
Affairs Forefront, March 14, 2024. DOI: 10.1377/
forefront.20240311.141546.
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Having Medicare Shared Savings
Program ACOs use the APP Plus quality
measure set allows for the
comprehensive incorporation of the
quality measures in the Adult Universal
Foundation measure set by the CY 2028
performance period/2030 MIPS
payment year and the better alignment
of the quality measures reported by
Medicare Shared Savings Program ACOs
with the Medicaid Core Sets and the
Marketplace Quality Rating System,
which have previously adopted the
quality measures in the Adult Universal
Foundation.740 Also, the alignment with
the Adult Universal Foundation would
better align the quality measures
reported by Medicare Shared Savings
Program ACOs with the Value in
Primary Care MIPS Value Pathway
(MVP). Alignment would allow
clinicians to leverage their familiarity
and experience with the Adult
Universal Foundation quality measures
among primary care clinicians
participating in this MVP as they
transition to reporting the APP Plus
quality measure set in the Medicare
Shared Savings Program. Experience
and familiarity with the same quality
measures, redesigned care processes,
and quality improvement activities that
are commonplace in ACOs would
streamline the pathway for clinicians to
join ACOs in the future, which is
consistent with our goal to have all
beneficiaries in an accountable care
relationship by 2030. The Medicare
Shared Savings Program has the
authority under section 1899(b)(3)(C) of
the Act to 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.
Lastly, we note that the existing
reporting requirements and scoring
policies established in § 414.1367(c)(1)
continue to be applicable to the APP
quality measure set. Similarly, the
existing scoring policies established in
§ 414.1367(c)(1) would be applicable to
the APP Plus quality measure set. As
discussed in more detail in section
IV.A.4.c.(3) of this proposed rule we are
proposing to require that all measures
within the APP Plus quality measure set
be reported (with the exception of the
administrative claims-based quality
measures that are automatically
calculated by CMS), and all measures in
the APP Plus quality measure set would
be scored, unless a measure does not
740 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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have a benchmark or meet the case
minimum requirements. If a measure
within the APP Plus quality measure set
does not have a benchmark or meet the
case minimum requirements, the
measure would still be required to be
reported in order to meet the reporting
requirements of the APP and for the
measure to be excluded from scored
(such measure would not contribute to
the quality performance category score
as long as the measure is reported). If
such a measure is not reported, then the
measure would fail to meet the
reporting requirements of the APP and
as a result, it would receive 0
achievement points.
We are seeking public comment on
the proposal to establish the data
submission criteria for the APP Plus
quality measure set, specifically the
proposal to require the reporting of all
measures within the APP Plus quality
measure set (with the exception of the
administrative claims-based quality
measures automatically calculated by
CMS).
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(c) Data Completeness Criteria
(i) Data Completeness Criteria for the
Quality Performance Category
As described in the CY 2017 Quality
Payment Program final rule (81 FR
77125 through 77126), 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
entitled to benefits under Part A or
enrolled under Part B of Medicare. For
the CY 2017 performance period/2019
MIPS payment year (first year of the
implementation of MIPS), we
established the data completeness
criteria threshold to reflect a threshold
of at least 50 percent (81 FR 77125). The
data completeness criteria threshold
means the following: an individual
MIPS eligible clinician, group, virtual
group, or APM Entity submitting
measure data on qualified clinical data
registry (QCDR) measures, MIPS clinical
quality measures (CQMs), or electronic
clinical quality measures (eCQMs) must
submit data on at least a specific percent
(that is, 50 percent as specified above
and 60 percent, 70 percent, and 75
percent as specified in the following
paragraphs) of their patients that meet
the measure’s denominator criteria,
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regardless of payer; an individual MIPS
eligible clinician, group, virtual group,
or APM Entity submitting quality
measure data on Medicare Part B claims
measures must submit data on at least
a specified percent (i.e., 50 percent as
specified above and 60 percent, 70
percent, and 75 percent as specified in
the following paragraphs) of their
Medicare Part B patients seen during the
corresponding performance period; and
an APM Entity, specifically a Medicare
Shared Savings ACO that meets the
reporting requirements under the APP,
submitting quality measure data on
Medicare CQMs must submit data on at
least a specified percent (that is, 70
percent and 75 percent as specified in
the following paragraphs) of the APM
Entity’s applicable beneficiaries eligible
for the Medicare CQM, as defined at
§ 425.20, who meet the measure’s
denominator criteria.
In the CY 2017 and CY 2018 Quality
Payment Program final rules and the CY
2020 PFS final rule, we noted that we
would increase the data completeness
criteria threshold over time (81 FR
77121, 82 FR 53632, and 84 FR 62951).
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
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).
Lastly, we maintained the data
completeness criteria threshold of at
least 75 percent for the CY 2026
performance period/2028 MIPS
payment year (88 FR 79334 through
79337).
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 Alternative
Payment Model (APM) Entities gain
experience with MIPS. The
incorporation of higher data
completeness criteria thresholds in
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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, 87 FR 70049,
and 88 FR 79334). In order to improve
compliance with the data completeness
threshold, 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, 87 FR 70049, and
88 FR 79334) such that all applicable
cases may be used when calculating a
measure. 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.
Increasing the data completeness
criteria threshold provides for a more
accurate assessment of performance. 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,741 it is
generally feasible for eligible clinicians
and groups to achieve a higher data
completeness criteria threshold without
jeopardizing their ability to successfully
participate and perform well in MIPS.
Our approach for increasing the data
completeness criteria threshold slowly
and incrementally over time enhances
the ability for individual MIPS eligible
clinicians, groups, virtual groups,
subgroups, and APM Entities to meet
the data completeness criteria threshold
as it increases and consequently,
enables successful participation under
MIPS. Thus, a data completeness
criteria threshold of less than 100
percent may reduce clinician burden
and accommodate operational issues
that may arise during data collection
during the initial years of the program
(82 FR 53632, 86 FR 65436, 87 FR
70049, and 88 FR 79334).
As MIPS eligible clinicians, groups,
virtual groups, and APM Entities have
gained experience participating in
MIPS, particularly meeting the data
completeness criteria threshold over the
last 8 years (from the CY 2017
performance period to the CY 2024
performance period), such experience
has prepared MIPS eligible clinicians,
groups, virtual groups, subgroups
(participation option available starting
with the CY 2024 performance period),
741 As described in the CY 2020 PFS final rule (84
FR 62951), the average data completeness rates
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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and APM Entities to meet incremental
increases in the data completeness
criteria threshold. We have maintained
a data completeness criteria threshold of
at least 70 percent for 4 years from the
CY 2020 performance period through
the CY 2023 performance period and as
a result, individual MIPS eligible
clinicians, groups, virtual groups, 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 starting with the CY
2024 performance period. We believed
that maintaining the data completeness
criteria threshold of at least 70 percent
for 4 years provided adequate time for
individual MIPS eligible clinicians,
groups, virtual groups, and APM
Entities to adjust to the increase that
went into effect at the onset of the
COVID–19 public health emergency and
account for the implications the
COVID–19 pandemic had on the
healthcare system.
As we assess the timeframe for a
potential future increase to the data
completeness criteria threshold, we
have determined that maintaining the
data completeness criteria threshold of
at least 75 percent for a total of 5 years
would provide sufficient time for MIPS
eligible clinicians, groups, virtual
groups, subgroups, and APM Entities to
adjust to the data completeness criteria
threshold of at least 75 percent. In
response to the proposal in the CY 2023
PFS proposed rule to increase the data
completeness criteria threshold to at
least 80 percent starting with the CY
2026 performance period/2028 MIPS
payment year, interested parties
indicated in the public comments that
increasing the data completeness
threshold from 75 to 80 percent within
two years of increasing the threshold
from 70 to 75 percent would present
various challenges such as the
following, which would make it more
difficult to meet the data completeness
criteria threshold: increased burden (in
particular, disproportionately increase
burden for smaller and rural practices
due to limited resources and staff, and
some practices that are continuing to
recover from the COVID–19 Public
Health Emergency); and exacerbated
technical and interoperability
challenges pertaining to data
aggregation across multiple EHRs,
systems (utilizing different registries,
and EHR developers and vendors), and
sites (including multiple TINs
participating in the Medicare Shared
Savings Program as an ACO) (88 FR
79337). We accept these concerns, and
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we thus believe that MIPS eligible
clinicians, groups, virtual groups,
subgroups, and APM Entities require
more time to adjust and prepare for an
increase. We have implemented the data
completeness criteria threshold of at
least 75 percent for 2 years. Specifically,
we previously established that for the
CY 2024 performance period through
the CY 2026 performance period/2026
MIPS payment year through the 2028
MIPS payment year, we would establish
and maintain the data completeness
threshold of at least 75 percent (87 FR
70049 through 70052, 88 FR 79334
through 79337). Therefore, for the CY
2027 and CY 2028 performance periods/
2029 and 2030 MIPS payment years, we
are proposing to maintain the data
completeness criteria threshold of at
least 75 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 as it
provides sufficient notice of the
expectation and subsequently, allows
such MIPS eligible clinicians, groups,
virtual groups, subgroups, and APM
Entities to prepare for a potential
increase in future years.
In this proposed rule, we are
proposing to maintain the data
completeness criteria threshold of at
least 75 percent for 2 additional years.
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 2027
and CY 2028 performance periods/2029
and 2030 MIPS payment years, 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.
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 2027
and CY 2028 performance periods/2029
and 2030 MIPS payment years, 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,
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subgroup, or APM Entity’s patients seen
during the corresponding performance
period to which the measure applies.
Additionally, 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 2027
and CY 2028 performance periods/2029
and 2030 MIPS payment years, an APM
Entity, specifically a Medicare 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 defined at § 425.20,
who meet the measure’s denominator
criteria.
Lastly, for the data completeness
criteria pertaining to the quality
performance category, we are proposing
a conforming amendment to recognize
that an APM Entity, specifically a
Medicare Shared Savings Program ACO
that meets the reporting requirements
under the APP, must meet the data
completeness criteria requirements
established at § 414.1340(d)(1).
We are seeking public comment on
these proposals.
(d) Selection of Quality Measures
(i) Addition of New Quality Measures
(A) Pre-Rulemaking Process
Prior to introducing a new MIPS
quality measure in a proposed rule,
CMS receives public input on measures
through the pre-rulemaking process
(referred to as the Pre-Rulemaking
Measure Review (PRMR)) established in
accordance with section 1890A of the
Act. Although section 1848(q)(2)(D)(viii)
of the Act provides that the prerulemaking process under section
1890A of the Act is not required to
apply to the selection of MIPS quality
measures, we have found that the prerulemaking process provides a
comprehensive review of measures from
multi-stakeholder workgroups and have
accordingly elected for such measures to
be reviewed utilizing the PRMR process
(87 FR 70048). Pursuant to the
established PRMR process (additional
information regarding the PRMR process
is available at https://p4qm.org/PRMR),
CMS has contracted with a ConsensusBased Entity (CBE), which is
responsible for convening a multistakeholder panel comprised of
clinicians, patients, measure experts,
and health information technology
specialists to provide input on measures
CMS is considering for use in Medicare.
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The pre-rulemaking process begins
with CMS’s publication of measures
under consideration for use in Medicare
(the MUC List). Each measure on the
MUC List is reviewed by one of several
committees convened by the PQM for
the purpose of providing multistakeholder input to the Secretary. The
PRMR process includes opportunities
for public comment through a 21-day
public comment period, as well as
public listening sessions. The PQM
posts the compiled comments and
listening session inputs received during
the public comment period and the
listening sessions within 5 days of the
close of the public comment period.
More details regarding the PRMR
process may be found in the PQM
Guidebook of Policies and Procedures
for Pre-Rulemaking Measure Review
and Measure Set Review.
The final vote of a multistakeholder
committee convened by the CBE may
result in the following disposition of a
measure: recommended, recommended
with conditions, do not recommend, or
no consensus. A ‘‘no consensus’’
recommendation signals continued
disagreement among the committee
despite being presented with
perspectives from public comment,
committee member feedback and
discussion, and highlights the multifaceted assessments of quality measures.
Quality measures that are considered for
potential implementation in MIPS
starting with the CY 2025 performance
period were included on the 2023
Measures Under Consideration (MUC)
List (available at https://
mmshub.cms.gov/sites/default/files/
2023-MUC-List.xlsx). The new MIPS
quality measures proposed are
described in Table Group A of
Appendix 1 of this proposed rule. There
may be cases in which the CBE does not
recommend for a measure to move
forward to the rulemaking process and
eventual implementation due to a
measure not being endorsed by the CBE
or other CBE, but we go forth with
proposing a measure. We note that
section 1848(q)(2)(D)(iii)(v)(III) of the
Act does not preclude the Secretary
from proposing and implementing
measures that are not endorsed by a CBE
as long as the measure is evidencebased.
(ii) Removal of Quality Measures
In this proposed rule, we are
codifying previously established criteria
for the removal of MIPS quality
measures from the MIPS quality
measure inventory. In the CY 2017
Quality Payment Program final rule (81
FR 77136 through 77137), we
established the following criteria for
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measure removal to include: If the
Secretary determines that the MIPS
quality measure is no longer
meaningful, such as MIPS quality
measures that are topped out; and, if a
measure steward is no longer able to
maintain the quality measure. In the CY
2019 PFS final rule (83 FR 59763), we
expanded the criteria for measure
removal to include MIPS quality
measures that reached an extremely
topped out status (for example, a
measure with an average mean
performance within the 98th to 100th
percentile range); the MIPS quality
measure may be proposed 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.
Also, in the CY 2019 PFS final rule
(83 FR 59764), we established other
criteria for measure removal,
specifically MIPS quality measures that
are: duplicative; not maintained or
updated to reflect current clinical
guidelines, which are not reflective of a
clinician’s scope of practice; and lowbar, standard of care process measures.
As described in the CY 2019 PFS final
rule (83 FR 59765), we established an
approach to incrementally remove
process measures where prior to
removal, consideration will be given to,
but will not be limited to the following:
• Whether the removal of the process
measure impacts the number of
measures available for a specific
specialty.
• Whether the MIPS quality measure
addresses a priority area highlighted in
the Measure Development Plan: https://
www.cms.gov/Medicare/QualityPayment-Program/MeasureDevelopment/
Measuredevelopment.html.
• Whether the MIPS quality measure
promotes positive outcomes in patients.
• Considerations and evaluation of
the measure’s performance data.
• Whether the MIPS quality measure
is designated as high priority or not.
• Whether the MIPS quality measure
has reached extremely topped out status
within the 98th to 100th percentile
range, due to the extremely high and
unvarying performance where
meaningful distinctions and
improvement in performance can no
longer be made.
Lastly, in the CY 2020 PFS final rule
(84 FR 62958 through 62959), we
expanded the criteria for measure
removal to include MIPS quality
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measures that do not meet case
minimum and reporting volumes
required for benchmarking after being in
the program for 2 consecutive CY
performance periods and not available
for MIPS quality reporting by or on
behalf of all MIPS eligible clinicians.
For MIPS quality measures that do not
meet case minimum and reporting
volumes required for benchmarking
after being in the program for 2
consecutive CY performance periods,
we noted that we will factor in other
considerations (such as, but not limited
to: The robustness of the measure;
whether it addresses a measurement
gap; if the measure is a patient-reported
outcome; and consideration of the MIPS
quality measure in developing MVPs)
prior to determining whether to remove
the MIPS quality measure.
We are proposing to codify the
aforementioned criteria established for
the removal of MIPS quality measures
from the MIPS quality measure
inventory in § 414.1330(c), respectively.
(iii) Inventory of 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
that the Secretary annually update the
list by removing measures from the list,
as appropriate; adding new measures to
the list, as appropriate; 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 2024
PFS final rule (88 FR 79556 through
79964), 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 inventory, as set
forth in Appendix 1 of this proposed
rule, including the following: the
addition of new measures; updates to
specialty sets (i.e., creation of new
specialty sets; addition and/or removal
of measures; and substantive changes to
existing measures within specialty sets);
removal of existing measures; and
substantive changes to existing
measures. For the CY 2025 performance
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period, we are proposing an inventory
of 196 MIPS quality measures.
The new MIPS quality measures that
we are proposing to include in MIPS for
the CY 2025 performance period and
future years can be found in Table
Group A of Appendix 1 of this proposed
rule. For the CY 2025 performance
period, we are proposing 9 new MIPS
quality measures, which includes 5 high
priority measures, of which 2 are also
patient-reported outcome measures.
On January 3, 2024, we announced
that we would be accepting
recommendations for potential new
specialty measure sets or revisions to
existing specialty measure sets for year
9 (CY 2017 performance period/2019
MIPS payment year through CY 2025
performance period/2027 MIPS
payment year) of MIPS under the
Quality Payment Program.742 The
recommendations we received were
based on the MIPS quality measures
finalized in the CY 2024 PFS final rule
and the 2023 MUC List; the
recommendations include the addition
or removal of current MIPS quality
measures from existing specialty sets,
and/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 are
proposed in this proposed rule. We are
proposing the addition of a new
specialty set and additionally proposing
modifications to existing specialty sets
as described in Table Group B of
Appendix 1 of this proposed rule.
Modifications to specialty sets include
the addition of new measures and/or
existing measures within the MIPS
quality measure inventory, removal of
measures, and/or substantive changes to
previously finalized measures (we refer
readers to Table Group D of Appendix
1 in this proposed rule). Specialty and
subspecialty sets are not inclusive of
every specialty or subspecialty. 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.
In addition to establishing new
individual MIPS quality measures,
modifying existing specialty sets, and
creating 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
742 Message to the Quality Payment Program
listserv on January 3, 2024, 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 2025 Performance Year of the
Merit-based Incentive Payment System (MIPS).’’
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Appendix 1 of this proposed rule for a
list of MIPS quality measures proposed
for removal and applicable rationale for
each measure. 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); and such
criteria is outlined in the proposed
§ 414.1330(c) (as further discussed in
section IV.A.4.e.(1)(d)(ii) of this
proposed rule). For the CY 2025
performance period, we are proposing to
remove 11 MIPS quality measures based
on the previously established criteria.
Of the 11 MIPS quality measures
proposed for removal, 2 MIPS quality
measures are duplicative to a proposed
new MIPS quality measure; 3 MIPS
quality measures are duplicative of
current measures; 1 MIPS quality
measure has reached the topped out
lifecycle; 2 MIPS quality measures are
extremely topped out; 1 MIPS quality
measure is no longer owned/
maintained; and 2 MIPS quality
measures have limited adoption and
consequently, have not been able to
establish benchmarks to provide a
meaningful impact to quality
improvement. 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). Seven of the
MIPS quality measures proposed for
removal are process measures that
would not provide granular information
related to disparities. The proposal to
remove the MIPS quality measures
described in Table Group C of Appendix
1 of this proposed rule would lead to a
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 MIPS
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 66
MIPS quality measures, which includes
2 MIPS quality measures previously
retained for utilization only in MVPs
(we refer readers to Table Group DD of
Appendix 1 of this proposed rule for
such measures). On an annual basis, we
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review the established MIPS quality
measure inventory to consider updates
to the measures. Possible updates to
measures may be minor or substantive.
The aforementioned proposed inventory
of 196 MIPS quality measures includes
193 MIPS quality measure available for
utilization in traditional MIPS and
MVPs, and 3 MIPS quality measures
available only for utilization in MVPs
(as finalized in the CY 2024 PFS final
rule (88 FR 79897 through 77902)). In
the CY 2024 PFS final rule, we removed
the following 3 MIPS quality measures
from traditional MIPS, but retained for
utilization in MVPs: Quality #112:
Breast Cancer Screening; Quality #113:
Colorectal Cancer Screening; and
Quality #128: Preventive Care and
Screening: Body Mass Index (BMI)
Screening and Follow-Up Plan (88 FR
79338 and 79897 through 79902). We
note that some MIPS quality measures
available in traditional MIPS and/or
MVPs are measures adopted by the
Medicare Shared Savings Program for
utilization under the APP, specifically
the APP quality measure set and the
newly established APP Plus quality
measure set, as proposed in section
IV.A.4.c.(3) of this proposed rule. For
the MIPS quality measures available in
the APP quality measure set and APP
Plus quality measure set for the CY 2025
performance period, we refer readers to
section IV.A.4.c.(1) and section
IV.A.4.c.(3) of this proposed rule.
Lastly, it should be noted that in this
proposed rule, we are proposing a
substantive change to the following
administrative claims measure, Quality
#492: Risk-Standardized Acute
Cardiovascular-Related Hospital
Admission Rates for Patients with Heart
Failure under the Merit-based Incentive
Payment System (we refer readers to
Table Group D of Appendix 1 of this
proposed rule), that would be applied
retroactively starting with the CY 2023
performance period/2025 MIPS
payment year. In the CY 2023 PFS final
rule, we inadvertently specified the
measure was availability at the
individual clinician level. The inclusion
of the availability of the measure at the
individual clinician level is a
misrepresentation and erroneously
conveys to MIPS eligible clinicians
reporting at the individual clinician
level that the measure is available to
meet the minimum required number of
measures to report under traditional
MIPS or an MVP. The measure was
tested and developed for
implementation at the group, virtual
group, subgroup via an MVP, and APM
Entity levels. Thus, the measure is
limited to groups, virtual groups,
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subgroups via an MVP, and APM
Entities participating in MIPS. We
believe that a failure to apply this
substantive change retroactively would
be contrary to the public interest.
Prior to the finalization of this
measure as a new measure available
within the MIPS quality measure
inventory in the CY 2023 PFS final rule,
the measure was initially proposed as a
new measure in the CY 2022 PFS
proposed rule. Based on the public
comments received in response to the
initial proposal of this measure in the
CY 2022 PFS proposed rule, there were
concerns regarding the attribution of
certain patients to clinicians,
particularly the risk adjustment for
clinicians with higher caseloads of
patients with more complicated or
severe heart failure. As a result, the
measure was not finalized as part of the
CY 2022 PFS final rule; however, we
noted that we would continue to
consider how to implement conditionspecific measures such as this measure
under MIPS (86 FR 65692 through
65694).
In the CY 2023 PFS proposed rule, we
re-proposed this measure, which
mitigated the concerns regarding the
attribution of such patients to clinicians
by excluding patients at advanced stages
of heart failure and requiring that a
group, virtual group, subgroup via an
MVP, and APM Entity to include at least
1 cardiologist (and a 21-patient case
minimum); and subsequently, the
measure was finalized in the CY 2023
PFS final rule (87 FR 70266 through
70271). The intent of the measure is for
assessment of performance to be
conducted at the group, virtual group,
subgroup via an MVP, and APM Entity
levels. The measure was not tested,
developed, or implemented at the
individual clinician level. In order for
this measure to be available at the
individual clinician level, the measure
would need to be tested at the
individual clinician level to establish
validity, reliability, and risk
adjustments at the individual clinician
level. It is not appropriate for the
measure to be available at the individual
clinician level without further testing.
Consequently, any assessment of data
for this measure at the individual
clinician level would produce invalid
and unreliable results. By retroactively
applying the substantive change to this
measure (modifying the measure to
remove the individual clinician level as
an option) effective starting with the CY
2023 performance period/2025 MIPS
payment year, the level of reporting
available for the measure would align
with the intent, implementation, and
operationalization of the measure, and
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clarify that the measure is not available
at the individual clinician level.
We are seeking public comment on
the proposals to modify the quality
performance category measure
inventory, a set of 196 MIPS quality
measures for the CY 2025 performance
period, which includes the following:
• Implementation of 9 new MIPS
quality measures: 5 high priority
measures, of which 2 are also patientreported outcome measures;
• Removal of 11 MIPS quality
measures: 2 MIPS quality measure are
duplicative to a proposed new quality
measure; 3 MIPS quality measures are
duplicative to current quality measures;
1 MIPS quality measure has reached the
topped-out lifecycle; 2 MIPS quality
measures are extremely topped out; 1
MIPS quality measure is no longer
owned/maintained; and 2 MIPS quality
measures have limited adoption and
consequently, have not been able to
establish benchmarks to provide a
meaningful impact to quality
improvement; and
• Substantive changes to 66 MIPS
quality measures.
We refer readers to Table Groups A
through DD of Appendix 1 of this
proposed rule for the proposed
modifications to the MIPS quality
measure inventory for the CY 2025
performance period.
(e) Quality Performance Category
Requests for Information
In this proposed rule, we are seeking
public comment on the following two
requests for information (RFIs) regarding
to the quality performance category (see
sections IV.A.4.e.(1)(e)(i) and
IV.A.4.e.(1)(e)(ii) of this proposed rule).
In accordance with the implementation
of regulations pertaining to the
Paperwork Reduction Act of 1995
(PRA), specifically 5 CFR 1320.3(h)(4),
the general solicitation of public
comments for the two RFIs are exempt
from the PRA. Facts or opinions
submitted in response to general
solicitations of public comments
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 themself,
other than that which is 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.
Respondents are encouraged to
provide complete, but concise
responses. The following RFIs are
issued solely for information and
planning purposes; they do not
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constitute a Request for Proposal (RFP),
applications, proposal abstracts, or
quotations. The RFIs do not commit the
U.S. Government to contract for any
supplies or services or make a grant
award. Further, CMS is not seeking
proposals through the following RFIs
and will not accept unsolicited
proposals. Respondents are advised that
the U.S. Government will not pay for
any information or administrative costs
incurred in response to the RFIs; all
costs associated with responding to the
RFIs will be solely at the interested
party’s expense. Not responding to the
RFIs do not preclude participation in
any future procurement, if conducted. It
is the responsibility of the potential
respondents to monitor these RFI
announcements for additional
information pertaining to the requests.
Please note that CMS will not respond
to questions about the policy issues
raised in the RFIs. CMS may or may not
choose to contact individual
respondents. Such communications
would only serve to further clarify
written responses. Contractor support
personnel may be used to review
responses for each RFI. Responses to
these notices 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 the
RFIs may be used by the U.S.
Government for program planning on a
non-attribution basis. Respondents
should not include any information that
might be considered proprietary or
confidential. The following RFIs 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. CMS may publicly post the
comments received, or a summary
thereof.
(i) Survey Modes for the Administration
of the Consumer Assessment of
Healthcare Providers and Systems
(CAHPS) for MIPS Survey Request for
Information
We are seeking public comment on
the potential expansion of the survey
modes of the CAHPS for MIPS Survey
from a mail-phone protocol to a webmail-phone protocol. The current
protocol is to administer the survey first
through the mail and then by phone
interview with non-respondents. The
expansion to the protocol would
include an initial administration of the
survey by web, followed by mail, and
then by phone. During the 2023 CAHPS
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groups, subgroups, and APM Entities
(including Medicare Shared Savings
Program ACOs)?
for MIPS Web Mode Field Test,743
adding the web-based survey mode to
the current mail-phone protocol of
CAHPS for MIPS survey administration
resulted in an increased response rate.
Surveys for the field test were
administered to a random sample of
8,613 survey-eligible patients from 20
Medicare Shared Savings Program ACOs
between March 6, 2023, and May 31,
2023, and were compared to survey data
collected from the CY 2022 performance
period CAHPS for MIPS Survey for the
same Medicare Shared Savings Program
ACOs. In total, 3,638 patients completed
a survey during the field test, resulting
in a 43 percent response rate for the
web-mail-phone protocol compared to
28 percent for the mail-phone protocol
from the CY 2022 performance period
CAHPS for MIPS Survey. The
percentage of patients with an email
address varied by ACO, ranging from 40
percent to 88 percent, and 38 percent of
sampled patients had an email address.
Evidence from the 2023 field test
indicates that the use of the web-mailphone protocol results in a higher
response rate. Analysis of this field test
data revealed that 43 percent of surveys
completed via the web-based survey
mode came from patients who did not
have an email address but responded by
entering a URL and patient-specific PIN
code printed in either the prenotification letter or web invitation
letter. The web-mail-phone protocol
also achieved higher response rates
among patients of Latino or Hispanic
ethnicity; no statistically significant
differences in response rates were found
by other demographic characteristics,
including gender, age, or race. Analysis
of the 2023 field test data also showed
that adding the web-based survey mode
reduced the response by mail from 93
percent during the CY 2022
performance period to 73 percent during
the field test timeframe.
Given the potential for an increased
response rate by expanding to a webmail-phone protocol, we are seeking
public comment on the following:
• Would the increase in survey
response rates (as shown from the
results of the 2023 CAHPS field test),
outweigh a possible increase in the cost
of survey administration that would be
associated with a three-mode survey
protocol (web-mail-phone) compared to
the current two-mode survey protocol
(mail-phone)?
• Would providing email addresses to
vendors be feasible for groups, virtual
(ii) Guiding Principles for PatientReported Outcome Measures in Federal
Models, and Quality Reporting and
Payment Programs Request for
Information
We are committed to elevating the
patient voice in healthcare. One critical
approach to elevating the patient voice
that is aligned with the CMS National
Quality Strategy and strategy of the CMS
Innovation Center is to incorporate more
Patient-Reported Outcome Measures
(PROMs) and Patient-Reported Outcome
Performance Measures (PRO–PMs) in
CMS quality reporting and payment
programs and CMS Innovation Center
Models.
CMS had defined a patient-reported
outcome (PRO) as any report of the
status of a patient’s health condition or
health behavior coming directly from
the patient without interpretation of the
patient’s response by a clinician or
anyone else.744 PROs are critical for the
support of person-centered care, as they
provide information from the patient or
caregivers perspective and offer
important information to improve
patient-clinician communication,
decision-making, and care delivery.
PROMs are structured tools used to
collect data on PROs, tested for validity
and reliability in the population of
interest. PRO–PMs aggregate
information collected using PROMs into
a reliable, valid measure of performance
at the measured entity level (for
example, clinician or health system).
Often these measures have established
benchmarks for assessing risk-adjusted
outcomes.
A potential path forward is the
development of an accessible and
unified database of PROMs/PRO–PMs
used in programs and payment systems
in health care by Federal, State-based,
and commercial payers, and healthcare
systems. This database would identify
the measure steward and include
information on the specifications of the
measure. The PROMs in this database
could serve as a resource for the
subsequent development of PRO–PMs.
Separately, considerations for a data
infrastructure that allows PROMs and
PRO–PMs to be integrated into clinical
workflow with minimal cost and
administrative burden, with data
seamlessly shared across different
healthcare settings and systems is
743 Centers for Medicare & Medicaid Services.
(June 2024). 2023 CAHPS for MIPS Web Mode Field
Test. Available at https://qpp-cm-prodcontent.s3.amazonaws.com/uploads/2893/2023_
CAHPS_for_MIPS_WebMode_Field_Test.pdf.
744 Centers for Medicare & Medicaid Services.
(December, 2023). Patient Reported Outcome
Measures. Available at https://mmshub.cms.gov/
sites/default/files/Patient-Reported-OutcomeMeasures.pdf.
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important. Although we recognize there
may be important reasons for not
restricting PROMs/PRO–PMs to a
strictly defined data infrastructure, we
seek to avoid the evolution of multiple
PROM/PRO–PM repositories that may
inhibit the development of these
measures and potentially impose
additional costs on clinicians and
healthcare systems.
One currently existing, unified, nonproprietary PROM repository is the
Patient-Reported Outcomes
Measurement Information System®
(PROMIS®) developed and funded by
the National Institutes of Health (NIH).
PROMIS tools assess patient-reported
health status for physical, social, and
mental wellbeing. NIH supported the
development of PROMIS, and in 2018
PROMIS was made available to the
public through a platform known as
HealthMeasures
(www.healthmeasures.net).
Northwestern University stewards
HealthMeasures and oversees
proprietary and copyright issues, as well
as scientific work using PROMIS
developed data elements and measures.
HealthMeasures also provides several
PRO–PMs for PROMIS available at
https://www.healthmeasures.net/
implement-healthmeasures/evaluatequality-of-care/healthmeasures-propms. As noted previously, this
repository of PROMs and PRO–PMs
could be used in conjunction with a
data infrastructure that integrates
PROMs and PRO–PMs into clinical
workflow and is able to be shared across
multiple healthcare environments.
As we move forward with including
more PROMs and PRO–PMs in CMS
quality reporting and payment programs
and CMS Innovation Center Models, it
is important to develop a set of guiding
principles and considerations for the
selection and implementation of PROMs
or PRO–PMs. An illustrative set of
guiding principles may include:
• Data Infrastructure—Measures
implemented in programs should, to the
extent possible, use existing data
systems for data collection and
reporting to minimize the
administrative burden associated with
collecting PROMs and deriving PRO–
PMs. The PROMs and PRO–PMs should
be deployed in a data infrastructure that
supports necessary interoperability
standards to support sharing across
providers, practices, hospitals, health
systems, health plans and States.
• Measure Testing—The PROMs have
been psychometrically tested and
undergone rigorous reliability and
validity testing (fully developed PRO–
PMs have also been tested for scientific
acceptability including reliability as a
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quality measure for the accountable
entity). Moreover, PROMs have been
tested as digital measures that can be
collected and reported electronically,
making their adaptation as electronic
Patient Reported Outcomes (ePROs)
feasible.
• Feasible Clinical Implementation—
Measures that will be used for clinical
decision making can be integrated into
the clinical workflow with minimal cost
and administrative burden. Further, the
data can be seamlessly shared across
different healthcare settings and payer
systems. The measures can be expected
to have meaningful participation and
response rates to draw conclusions from
measure score results (based on
anticipated sample size from
participating providers).
• Accessible—The measures are
easily accessible to clinicians and care
teams, without the creation of
additional administrative or significant
financial burdens, or the requirement
for additional resources.
• Patient Engagement—The measures
have been tested to show that the
concept is meaningful to patients.
Additionally, there is a validated
feedback loop on how their patientreported data is used to drive
performance improvement. and
improvement in individual patient
outcomes/experience.
• Equity—Measures selection
considers how measurement may
ameliorate or exacerbate disparities
including but not limited to
considerations for language
concordance and response rates.
Measures may be stratified by subgroup
to better understand disparities in
response rates and outcomes.
Through this RFI, we are seeking
comment on principles related to data
infrastructure, selection, feasible
implementation, and patient
engagement of PROMs and PRO–PMs.
We request feedback from the public
regarding the overarching principles
and considerations.
Specifically we are seeking input on
the following areas:
• Are the aforementioned guiding
principles outlined comprehensive or
are there additional guiding principles
and considerations we should consider
for the selection, and implementation of
PROM and PRO–PMs?
• How can CMS accelerate the
development of PRO–PMs and advance
them more rapidly into use? How can
CMS support PRO–PM development
while balancing the goal of accessible
PRO–PMs with the additional time and
resources required to construct PROMs
and PRO–PMs from a PROM?
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• How should CMS balance the use of
broad PRO–PMs that might be
applicable across multiple clinical
contexts compared to condition-specific
PROMs and PRO–PMs measures that
can be more tailored to a given clinical
situation but lead to a greater number of
tools in use across measures and health
care providers?
• How can CMS support making
PROMs broadly accessible without
limiting both innovation and resources
committed to developing new tools? Are
there other examples (beside PROMIS)
of currently existing PROMs/PRO–PMs
repositories that make their tools widely
available to clinicians and healthcare
systems?
(2) Cost Performance Category
Section 1848(q)(2)(A) of the Act
includes resource use as a performance
category under 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 MIPS
are used in determining the MIPS final
score for each MIPS eligible clinician. In
general, MIPS eligible clinicians are
evaluated under all four of the MIPS
performance categories, including the
cost performance category.
We are proposing to add six new
episode-based measures to the cost
performance category beginning with
the CY 2025 performance period/2027
MIPS payment year. These six measures
include:
• Chronic Kidney Disease (CKD),
which assesses MIPS eligible clinicians
on the risk-adjusted and specialtyadjusted cost to Medicare for patients
who receive care to manage and treat
CKD stages 4 and 5;
• End-Stage Renal Disease (ESRD),
which assesses MIPS eligible clinicians
on the risk-adjusted and specialtyadjusted cost to Medicare for patients
who receive medical care to manage
ESRD;
• Kidney Transplant Management,
which assesses MIPS eligible clinicians
on the risk adjusted and specialtyadjusted cost to Medicare for ongoing
kidney transplant-related care and
management starting at least 90 days
after transplant surgery;
• Prostate Cancer, which assesses
MIPS eligible clinicians on the riskadjusted and specialty-adjusted cost to
Medicare for the management and
treatment of prostate cancer;
• Rheumatoid Arthritis, which
assesses MIPS eligible clinicians on the
risk-adjusted and specialty-adjusted cost
to Medicare for the management and
treatment of rheumatoid arthritis; and
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• Respiratory Infection
Hospitalization, which assesses MIPS
eligible clinicians on the risk-adjusted
cost to Medicare for the inpatient
treatment of respiratory infection.
We are proposing modifications to
two existing episode-based measures so
that their specifications reflect
reevaluated versions beginning with the
CY 2025 performance period/2027 MIPS
payment year. These two measures are:
• Cataract Removal with Intraocular
Lens (IOL) Implantation, which assesses
MIPS eligible clinicians on the risk
adjusted cost to Medicare for cataract
removal procedures; and
• Inpatient (IP) Percutaneous
Coronary Intervention (PCI), which
assesses MIPS eligible clinicians on the
risk-adjusted cost to Medicare for the
inpatient PCI treatment of patients who
present with a cardiac event.
We are proposing that MIPS eligible
clinicians must be attributed a
minimum of 20 cases for each of the
proposed six new measures. In addition,
we are proposing to maintain the
existing case minimums for the two
measures we are proposing to modify in
this rulemaking, which are a 20-episode
case minimum for the IP PCI measure
and a 10-episode case minimum for the
Cataract Removal with IOL Implantation
measure. We are also proposing to
update the operational list of care
episode and patient condition groups
and codes to reflect these new and
modified measures we are proposing.
Finally, we are proposing to adopt
criteria to specify objective bases for the
removal of any cost measures from the
MIPS cost performance category, which
we are also proposing to codify at
§ 414.1350(e).
For a description of the statutory
authority 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), CY 2023
PFS final rule (87 FR 70055 through
70057), and CY 2024 PFS final rule (88
FR 79339 through 79349).
More details on the proposals in this
section, which we invite comments on,
are provided in section IV.A.4.e.(2)(a)
through section IV.A.4.e.(2)(d) of this
proposed rule. We also refer readers to
section V.B.8.k. of this proposed rule for
discussion on the burden estimates for
these proposals.
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(a) Proposed Updates to MIPS EpisodeBased Measure Inventory
(i) Background on Episode-Based
Measure Development and Use
Under § 414.1350(a), we specify cost
measures for a performance period to
assess the performance of MIPS eligible
clinicians on the cost performance
category. There are currently 29 cost
measures in the cost performance
category for the CY 2024 performance
period/2026 MIPS payment year,
comprising of 27 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 six new episodebased measures through empirical
analyses and public comment. These
measures cover clinical topics and MIPS
eligible clinicians practicing in certain
specialties for whom there are currently
limited or no applicable cost measures.
As such, these measures would help fill
gaps in the cost performance category’s
measure set.
In addition, these measures would
support the transition from traditional
MIPS to MVPs by allowing new MVPs
to be created and enhancing existing
MVPs. Further, the addition of these
measures would address interested
parties’ feedback about the need for
more clinically refined episode-based
measures in the cost performance
category. The measures would also
increase the cost coverage of care
episode and patient condition 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 the
Medicare Program and beneficiaries for
the items and services furnished to
Medicare beneficiaries during an
episode. They aim to compare MIPS
eligible clinicians on the basis of the
cost of care that is clinically related to
treatment and management of a
Medicare beneficiary 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
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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/2023part-d-rebate-methodology.pdf. We refer
the readers to section IV.A.4.e.(2)(a)(iii)
of this proposed rule for more
information on the six episode-based
measures we are proposing.
In this proposed rule, we provide
detail about the six new measures that
we are proposing to adopt in the cost
performance category beginning with
the CY 2025 performance period/2027
MIPS payment year. In section
IV.A.4.e.(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.e.(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 2025 performance period/
2027 MIPS payment year. In section
IV.A.4.e.(2)(a)(viii) of this proposed
rule, we discuss the pre-rulemaking
review process these measures
underwent. In section IV.A.4.e.(2)(b) of
this proposed rule, we discuss our
proposal that MIPS eligible clinicians
must be attributed a minimum of 20
cases for each of these proposed
measures to be assessed and scored on
such measure.
(ii) Overview of Measure Development
Process for New Episode-Based
Measures
In this section, we describe the
development process for the six
proposed episode-based measures.
Development of episode-based
measures for the cost performance
category must comply with section
1848(q)(2)(B)(ii) of the Act, which
provides that measures and activities
specified for a performance period
include the measurement of resource
use (cost) as provided under section
1848(p)(3) of the Act, using the
methodology under section 1848(r) of
the Act, to collaborate with physicians,
practitioners, and other interested
parties, as appropriate. Section
1848(p)(3) of the Act provides that costs
shall be evaluated, to the extent
practicable, based on a composite of
appropriate measures of costs
established by the Secretary as further
specified therein. We note that the
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measure development contractor 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 six 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.e.(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
Payment Program final rule (82 FR
53644 and 53645), the CY 2019 PFS
final rule (83 FR 59767 through 59769),
the CY 2022 PFS proposed rule (86 FR
39396 and 39397), and the CY 2024 PFS
proposed rule (88 FR 52568 through
52576). 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
conversations between persons with
lived experience and clinical experts.
We began development of the six
episode-based measures across several
of these waves:
• The Prostate Cancer, Rheumatoid
Arthritis, and Kidney Transplant
Management measures were initiated in
Wave 5 in 2022 and followed the typical
18-month process.
• The CKD and ESRD measures were
initiated in 2021 as part of an off-cycle
development process and were
incorporated into Wave 5 in 2022 to be
completed along with the other three
episode-based measures (that is,
Prostate Cancer, Rheumatoid Arthritis,
and Kidney Transplant Management).
• The Respiratory Infection
Hospitalization measure is a revised
version of the Simple Pneumonia with
Hospitalization measure that was
initially developed in Wave 1 in 2018.
The Simple Pneumonia with
Hospitalization measure was adopted in
MIPS in the CY 2019 PFS final rule (83
FR 59767 through 59773) and then
removed from use in MIPS in the CY
2024 PFS final rule (88 FR 79348 and
79349). The measure underwent a
comprehensive reevaluation process
from 2022–2023 to identify and
incorporate refinements based on public
feedback, clinical input, and empiric
testing. Unlike the other five new
measures we are proposing, this
measure did not undergo further
development as part of Wave 5. Because
the Simple Pneumonia with
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Hospitalization measure is no longer in
use in MIPS, we are proposing the
Respiratory Infection Hospitalization
measure as a new measure, and not as
modifications to an existing measure.
More information on the comprehensive
reevaluation process that this measure
underwent is described in sections
IV.A.4.e.(2)(a)(iv) and IV.A.4.e.(2)(a)(v)
of this proposed rule.
This section of this proposed rule will
provide more details on the
development process for the measures
that were developed during Wave 5
(CKD, ESRD, Kidney Transplant
Management, Prostate Cancer, and
Rheumatoid Arthritis measures). We
began developing the CKD and ESRD
measures in 2021 as priority clinical
areas by convening a clinician expert
workgroup and gathering feedback from
persons with lived experience.
However, the clinician expert
workgroup recommended that we
develop a Kidney Transplant
Management measure to fully capture
the care continuum of kidney disease
care before continuing to move forward
with the CKD and ESRD measures. As
a result, we halted measure
development on the CKD and ESRD
measures until 2022, while we gathered
public feedback on the development of
a Kidney Transplant Management
measure, and later incorporated the
CKD and ESRD measures into the Wave
5 development process.
The episode-based measures that were
developed in the Wave 5 cycle of
measure development (CKD, ESRD,
Kidney Transplant Management,
Prostate Cancer, and Rheumatoid
Arthritis measures) underwent an 18month development process. As a first
step, the measure development
contractor held a public comment
period from February to April 2022 to
gather feedback on which clinical areas
to prioritize for measure development.
The public comment period solicited
feedback on the importance and
feasibility of prioritizing kidney
transplant management, prostate cancer,
and rheumatoid arthritis, among other
clinical areas, for measure development.
During the public comment period, the
measure development contractor
received 32 comments on the candidate
episode groups for development in
Wave 5. We used this feedback, in
conjunction with empirical testing by
the measure development contractor, to
inform our decision to develop
measures for three specific clinical
areas—prostate cancer, rheumatoid
arthritis, and kidney transplant
management—into episode-based
measures. The summary of the public
comments is available in this document
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https://www.cms.gov/files/document/
wave-5-public-comment-summaryreport.pdf. We selected these clinical
areas for measure development for
several reasons including:
representation of high priority clinical
areas, potential to improve clinician
performance or patient outcomes,
potential to capture high costs of care
paid by the Medicare Program, and
ability to fill measurement gaps in the
MIPS cost performance category and
MVPs.
Following our decision to develop
measures for prostate cancer,
rheumatoid arthritis, and kidney
transplant management, in addition to
continuing to develop the CKD and
ESRD measures, the measure
development contractor convened four
clinician expert panels, comprised of a
total of 45 members, affiliated with 36
organizations and specialty societies.
The CKD and ESRD measures shared a
clinician expert panel due to the close
clinical overlap of these diseases. Each
panel also incorporated the perspective
of persons with lived experience; 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 17, 2023, to
February 14, 2023 for the Wave 5
measures (CKD, ESRD, Kidney
Transplant Management, Prostate
Cancer, and Rheumatoid Arthritis
measures). During this field testing
period, individual MIPS eligible
clinicians and groups meeting a
minimum threshold of 20 episodes for
each measure could review field test
reports and an episode-level file with
detailed 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 feedback via survey and a
summary of this feedback from the field
testing period is available at https://
www.cms.gov/files/document/2023field-testing-feedback-summaryreport.pdf.
The measure development contractor
also has a standing technical expert
panel (TEP), which is referred to as the
Physician Cost Measures and Patient
Relationship Codes (PCMP) TEP. The
PCMP TEP is composed of 20 members
from different clinical areas, academia,
health care and hospital administration,
and persons with lived experience,
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which provides overarching input on
cross-measure topics, such as testing
approaches and methodology. For
example, the PCMP TEP discussed
general challenges in developing
chronic condition episode-based
measures and ways that the chronic
condition 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, which support the overall
development of episode-based
measures, including, but not limited to
those episode-based measures being
proposed in this rulemaking. This input
helped inform the specifications for the
chronic condition episode-based
measure framework, which serves as the
framework for the chronic condition
episode-based measures (that is,
Prostate Cancer, Rheumatoid Arthritis,
CKD, ESRD, and Kidney Transplant
Management episode-based measures)
developed in Wave 5 and being
proposed in this proposed rule.
More information about the measure
development and interested parties’
engagement process for the six episodebased measures we are proposing for
adoption in the cost performance
category is available in materials on the
QPP Cost Measure Information page at
https://www.cms.gov/medicare/quality/
value-based-programs/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/quality/valuebased-programs/cost-measures.
Descriptions of the methods through
which the measure development
contractor gathered expert input during
measure development and other
interested parties’ engagement activities
is available in the ‘‘2024 MIPS Summary
of Cost Measures’’ document at https://
www.cms.gov/files/document/2024mips-summary-costs-measures.pdf.
(iii) Description of Six New EpisodeBased Measures Proposed for Adoption
Beginning With the CY 2025
Performance Period/2027 MIPS
Payment Year
In this section of this proposed rule,
we discuss the six new episode-based
measures, which we propose to add to
the cost performance category beginning
with the CY 2025 performance period/
2027 MIPS payment year.
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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 six 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
episode-based measures later in this
section of this rulemaking.
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 six proposed episodebased measures.
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, for the Rheumatoid Arthritis
episode-based measure, rheumatoid
arthritis severity, fractures, frailty, and
cognitive status). 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
62047
described in detail in CY 2019 PFS final
rule (83 FR 59767 through 59773). As
mentioned previously in this section, all
six 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 adoption beginning
with the CY 2025 performance period/
2027 MIPS payment year are set forth in
Table 58.
TABLE 58: Proposed Episode-Based Measures Beginning with CY 2025 Performance
Period/2027 MIPS Payment Year
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The five chronic condition episodebased measures assess outpatient
treatment and ongoing management of
the following chronic conditions: CKD,
ESRD, kidney transplant management,
prostate cancer, and rheumatoid
arthritis. These measures assess the
costs of services related to these
conditions, such as physician services,
imaging or diagnostic services,
emergency room care or
hospitalizations, medications, or other
services related to ongoing management
or post-acute care. The measure
construction for these proposed
measures follows the approach
described in the CY 2022 PFS final rule
(86 FR 65445 through 65461), which
also includes detailed discussion of the
attribution methodology and examples
of how episodes are attributed.
To briefly summarize, the attribution
methodology that identifies a clinicianpatient care relationship for these
chronic condition episode-based
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measures 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.
Both claims must have a diagnosis code
indicating the same chronic condition
related to the specific episode-based
measure. For example, for the Prostate
Cancer measure, both claims of the
trigger event must have a diagnosis
indicating prostate cancer. 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
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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.
Note, some measures also use additional
CPT/HCPS codes with a relevant
diagnosis as the initial trigger service.
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
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EP31JY24.090
Episode Type
Chronic condition
Chronic condition
Chronic condition
Chronic condition
Chronic condition
Acute inpatient medical condition
Measure Name
Chronic Kidney Disease (CKD)
End-Stage Renal Disease (ESRD)
Kidney Transplant Management
Prostate Cancer
Rheumatoid Arthritis
Respiratory Infection Hospitalization
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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, for some measures, we
use provider-level prescription billing
patterns to ensure that we are capturing
the MIPS eligible clinicians directly
involved in providing ongoing chronic
care management. Specifically, for some
measures, the MIPS eligible clinician
must also have prescribed at least two
prescriptions claimed under Medicare
Part D and/or Medicare Part B related to
the management of the condition for
two different patients during the
measurement period, plus a one-year
lookback period. These conditions,
which we use to attribute a cost measure
to MIPS eligible clinicians, also apply to
the attribution methodology at the
clinician group level. Specifically, the
clinician group would always meet the
first condition by construction (that is,
there would always be an individual
MIPS eligible clinician under the
clinician group that has provided care to
the patient prior to or on the episode
start date). However, the clinician group
must have at least one potentially
attributable MIPS eligible clinician
under it who meets the second
condition.
More information about the chronic
condition episode-based measures
attribution methodology, including a
one-page summary and a Frequently
Asked Questions (FAQ) document, is
available at https://www.cms.gov/files/
zip/mips-chrcondition-episode-basedcost-measures-attribution-methodology2023-zip.zip. More general information
about the overall chronic condition cost
measure framework is available at
https://www.cms.gov/files/document/
chronic-condition-cost-measureframework-poster.pdf.
The Respiratory Infection
Hospitalization measure is an acute
inpatient medical condition episodebased measure, which focuses on the
inpatient treatment of respiratory
infection and is attributed to clinicians
and clinician groups treating a patient
during the hospitalization. It includes
the cost of services related to the
inpatient treatment of a respiratory
infection, such as initial inpatient
services, subsequent outpatient
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physician visits, and emergency room
care or hospitalizations for related
complications. As noted in section
IV.A.4.e.(2)(a)(ii) of this proposed rule,
the Respiratory Infection
Hospitalization measure is the
reevaluated version of the Simple
Pneumonia with Hospitalization
measure, adopted for MIPS in CY 2019
PFS final rule (83 FR 59767 through
59773) and removed from MIPS in the
CY 2024 PFS final rule (88 FR 79348
and 79349). We developed the Simple
Pneumonia with Hospitalization acute
inpatient medical condition measure in
accordance with the previously
established framework for episodebased measures, which we described in
detail in the CY 2019 PFS final rule (83
FR 59769 through 59771). The Simple
Pneumonia with Hospitalization
measure was reevaluated following the
process described in sections
IV.A.4.e.(2)(a)(iv), IV.A.4.e.(2)(a)(v), and
IV.A.4.e.(2)(a)(viii) of this proposed
rule. We are proposing the Respiratory
Infection Hospitalization measure, the
reevaluated version of the Simple
Pneumonia with Hospitalization
measure, because we continue to believe
it is important to capture pneumonia
and other respiratory infections, as
pneumonia is a leading infectious cause
of hospitalization and death among
adults in the United States.745 This new,
revised measure addresses the concerns
with the previous version of the
measure by expanding the patient
cohort to include beneficiaries
hospitalized for pneumonia and related
respiratory infections, reflecting the
coding changes as described in the CY
2024 PFS final rule (88 FR 79348 and
79349). The revised measure also
incorporates feedback we received from
interested parties about appropriate risk
adjustment and exclusions during the
reevaluation process of the prior Simple
Pneumonia with Hospitalization
measure.
The specifications for all six episodebased measures we are proposing for
adoption in this rulemaking are
available at https://www.cms.gov/
medicare/quality/value-basedprograms/cost-measures. The
specifications documents for each
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
methodology describing each step to
745 Regunath, Hariharan, and Yuji Oba.
‘‘Community-Acquired Pneumonia.’’ National
Library of Information, August 8, 2022. https://
www.ncbi.nlm.nih.gov/books/NBK430749.
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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 episodebased measures is available in the
measure justification forms, which were
posted to support Pre-rulemaking
Measure Review (PRMR) discussions.
These documents provide a
comprehensive characterization of the
measures, their justification, and testing
results of the measures’ specifications at
this time. These documents are
available through the QPP Cost Measure
Information page at https://
www.cms.gov/medicare/quality/valuebased-programs/cost-measures.
(iv) Background on Episode-Based
Measure Reevaluation and Maintenance
In this section, we describe the
measure maintenance process we use, in
conjunction with our measure
development contractor, to monitor,
evaluate, and potentially modify cost
measures. Using this maintenance
process, we holistically reviewed, and
evaluated whether to modify or take
other actions with respect to, certain
measures in the cost performance
category. As a result of this process, we
propose to modify two episode-based
measures currently in use (the Routine
Cataract Removal with Intraocular Lens
(IOL) Implantation and ST-Elevation
Myocardial Infarction (STEMI)
Percutaneous Coronary Intervention
(PCI) measures), and propose the
reevaluated Respiratory Infection
Hospitalization as a new measure,
replacing the Simple Pneumonia with
Hospitalization measure previously
removed from the cost performance
category.
The measure development contractor
routinely conducts three types of
measure maintenance: measure
monitoring, annual measure
specifications updates, and
comprehensive reevaluation.
Comprehensive reevaluation occurs
every 3 years after a measure is
implemented in MIPS. The purpose of
comprehensive reevaluation 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://mmshub.cms.gov/
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blueprint-measure-lifecycle-overview).
In this process, we holistically review
the measure, seek public comment, and
consider whether any changes need to
be made to measure specifications. A
new version of the measure may be
considered for implementation in MIPS
in future years, after undergoing the prerulemaking and the notice-andcomment rulemaking processes. For
more information on recent reevaluation
efforts, 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/quality/valuebased-programs/cost-measures/prior.
For the purpose of assessing
performance of MIPS eligible clinicians
in the cost performance category, we
finalized, in the CY 2019 PFS final rule
(83 FR 59767 through 59773), the
Routine Cataract Removal with
Intraocular Lens (IOL) Implantation, STElevation Myocardial Infarction
(STEMI) Percutaneous Coronary
Intervention (PCI), and Simple
Pneumonia with Hospitalization
measures to be included in MIPS
beginning with the CY 2019
performance period/2021 MIPS
payment year. In this section, we are
proposing to modify the Routine
Cataract Removal with IOL Implantation
and STEMI PCI measures based on
input from interested parties from prior
public comment periods and
recommendations from Clinician Expert
Workgroups.
62049
We also propose to modify the
measure titles. Routine Cataract
Removal with Intraocular Lens (IOL)
Implantation would be revised to
Cataract Removal with Intraocular Lens
(IOL) Implantation to reflect substantive
changes to the measure exclusions. STElevation Myocardial Infarction
(STEMI) Percutaneous Coronary
Intervention (PCI) would be revised to
Inpatient (IP) Percutaneous Coronary
Intervention (PCI) to reflect the
inclusion of patients with a non-STEMI
PCI diagnosis and patients with a PCI
diagnosis but neither STEMI nor nonSTEMI diagnoses.
The episode-based measures that we
propose to modify beginning with the
CY 2025 performance period/2027 MIPS
payment year are listed in the Table 59.
TABLE 59: Proposed Reevaluated Episode-Based Measure Modifications Beginning with
CY 2025 Performance Period/2027 MIPS Payment Year
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(v) Overview of Measure Reevaluation
Process for Episode-Based Measures
As part of the reevaluation process,
we worked with the measure
development contractor to gather
feedback from interested parties on
potential refinements to the measures.
The measure development contractor
worked with a standing TEP, Clinician
Expert Workgroups, and held two
public comment periods.
Initially, a public comment period
was held from February to May 2022 to
gather feedback on which of the Wave
1 measures implemented in MIPS in
2019 that the measure developer should
prioritize reevaluating. A summary of
public comments from the 2022 public
comment period can be found in the
Wave 1 Comprehensive Reevaluation
Public Comment Summary Report at
https://www.cms.gov/files/document/
wave-one-public-comment-summaryreport.pdf.
The measure development contractor
then convened the TEP for a meeting in
August 2022 to provide input on the
comprehensive reevaluation process for
all Wave 1 episode-based measures. In
October 2022, the measure development
contractor convened the Cataract
Removal with IOL Implantation
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Revised Measure Name
Cataract Removal with
lntraocular Lens (IOL)
Implantation
Inpatient (IP) Percutaneous
Coronary Intervention (PCI)
Clinician Expert Workgroup, the IP PCI
Clinician Expert Workgroup, and the
Respiratory Infection Hospitalization
Clinician Expert Workgroup, to provide
detailed clinical input on measure
specifications for each reevaluated
measure. This input was informed by
empiric testing conducted by the
measure development contractor. The
workgroup discussions from October
2022 can be found in the Summary of
Wave 1 Comprehensive Reevaluation
Workgroup meetings at https://
www.cms.gov/files/zip/summary-wave1-comprehensive-reevaluationworkgroup-meetings.zip.
After this, a second public comment
period was held in February 2023 to
gather feedback on the draft revisions
the measure developer made to the
Cataract Removal with IOL
Implantation, IP PCI, and Respiratory
Infection Hospitalization measures. A
summary of public comments from the
2023 public comment period can be
found in the 2023 Revised Cost Measure
Feedback Period Summary Report at
https://www.cms.gov/files/document/
2023-revised-cost-measure-feedbackperiod-summary-report.pdf.
The measure-specific expert
workgroups then reviewed the feedback
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Eoisode Tvoe
Procedural
Acute inpatient medical
condition
received through public comments and
provided input on proposed decisions
regarding the measure specifications.
The workgroup discussions from Spring
2023 are available in the Summary of
Wave 1 Post-Feedback Period
Workgroup meetings at https://
www.cms.gov/files/zip/summary-wave1-post-feedback-period-pfr-workgroupmeetings-23.zip. After the proposed
specifications for each measure were
finalized, we submitted the three
revised measures (Cataract Removal
with IOL Implantation, IP PCI, and
Respiratory Infection with
Hospitalization measures) to the 2023
MUC list and underwent review by the
PRMR Clinician Committee and
Clinician Committee Recommendation
Group, which reviewed the measures for
use in MIPS. We provide more
information about this discussion in
section IV.A.4.e.(2)(a)(viii) of this
proposed rule.
E:\FR\FM\31JYP2.SGM
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EP31JY24.091
Ori2inal Measure Name
Routine Cataract Removal with
Intraocular Lens (IOL)
Implantation
ST-Elevation Myocardial
Infarction (STEM!) Percutaneous
Coronarv Intervention (PCI)
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Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
(vi) Description of Proposed
Modifications to the Routine Cataract
Removal With Intraocular Lens (IOL)
Implantation Measure With the Newly
Titled Cataract Removal With IOL
Implantation Measure
We finalized the Routine Cataract
Removal with Intraocular Lens (IOL)
Implantation cost measure in the CY
2019 PFS final rule (83 FR 59767
through 59773) for use in MIPS as an
important measure of clinician cost
performance, as cataract surgery is the
most common surgical procedure in the
United States.746 We continue to believe
that the existing measure is appropriate
to use in MIPS. When we finalized this
measure for use in MIPS, we noted that
as with all the cost measures, we would
maintain this measure and update its
specifications as appropriate (83 FR
59766 and 59767). As a part of our
routine measure maintenance, we
reevaluated the Routine Cataract
Removal with IOL Implantation
measure with consideration of input
from interested parties and testing. This
feedback from interested parties
included:
• The patient cohort for the measure
should be expanded, while still
accounting for patient heterogeneity, to
expand clinician and beneficiary
coverage.
• The measure should account for
patients with ocular conditions that
impact case complexity to account for
patient heterogeneity.
• Certain Medicare Part B medication
costs related to cataract procedures
should be included in the measure,
while Medicare Part D medication costs
should remain excluded to better
account for more clinically-related
medication costs.
• The measure should more broadly
capture services associated with cataract
removal.
In response to this feedback, CMS and
the measure development contractor
conducted additional empirical analyses
and discussed potential modifications
with the measure-specific expert
workgroup. Summaries of these
discussions are available here: https://
www.cms.gov/medicare/quality/valuebased-programs/cost-measures/prior.
Based on these testing results and the
clinician expert input, we are proposing
to replace the Routine Cataract Removal
with IOL Implantation with the revised
Cataract Removal with IOL Implantation
cost measure. The modifications that we
are proposing to incorporate into the
746 Pershing, S., D.E. Morrison, and T. HernandezBoussard. ‘‘Cataract Surgery Complications and
Revisit Rates among Three States.’’ [In eng]. Am J
Ophthalmol 171 (Nov 2016): 130–38.
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revised Cataract Removal with IOL
Implantation measure and our rationale
is outlined as follows.
First, we propose to modify this cost
measure by expanding the patient
cohort based on changes to the
exclusion criteria. Testing has shown
that many episodes excluded due to
ocular conditions had similar cost
profiles, compared to episodes included
in the measure, and represented a
significant portion of triggered episodes.
The measure-specific expert workgroup
discussed the appropriateness of the
original exclusion criteria and
recommended potential revisions. The
proposed revised measure includes
patients with certain previously
excluded ocular conditions, such as
glaucoma and macular degeneration, in
the measure cohort because of their
similar cost profiles. In response to
expanding the measure cohort, we also
propose updates to the risk adjustment
model to risk adjust for ocular
conditions that are no longer excluded
but may still impact case complexity
and episode costs. We believe that these
changes are appropriate as they further
account for patient heterogeneity in the
more clinically diverse patient cohort.
However, the proposed revised measure
continues to exclude episodes for
patients with significant ocular
conditions impacting surgical
complication rate or visual outcomes
because testing did not suggest they had
similar enough cost profiles for any
expected cost differences to be
accounted for through risk adjustment.
Second, we propose to modify this
cost measure’s service assignment
specifications in two ways, to include:
(1) certain clinically-related telehealth
services, pre-operative testing,
emergency department (ED) visits for
ocular complaints, and postoperative
durable medical equipment (DME); and
(2) certain additional clinically-related
Medicare Part B medication costs that
were not initially included in the
measure. The previous version of the
measure included a smaller subset of
these services. However, testing showed
that additional clinically-related
services within these categories occur
during Cataract Removal episodes and
exclusion of these services from the
measure could result in failure to
capture important costs. We are
proposing to include the additional
services because we believe this change
would retain the original intent of the
measure while capturing a more
complete picture of cost performance
variation. Additionally, we are
proposing to expand the types of Part B
medications assigned to the measure
because we believe it would be
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appropriate to use similar service
assignment rules for all clinicallyrelated Part B medications.
Further details about the revised
Cataract Removal with IOL Implantation
measure are available in the measure
specifications documents, which are
available at https://www.cms.gov/
medicare/quality/value-basedprograms/cost-measures.
(vii) Description of the Proposed
Modifications to the ST-Elevation
Myocardial Infarction (STEMI) With
Percutaneous Coronary Intervention
(PCI) Measure With the Newly Titled
Inpatient (IP) Percutaneous Coronary
Intervention (PCI) Measure
Similar to the Cataract Removal with
IOL Implantation measure, we finalized
the ST-Elevation Myocardial Infarction
(STEMI) Percutaneous Coronary
Intervention (PCI) measure in the CY
2019 PFS final rule (83 FR 59767
through 59773) for use in MIPS as an
important measurement of clinician cost
performance, due to the high frequency
and cost of PCI procedures in the United
States. PCI is one of the most common
procedures for cardiac events (AMIs)
and is associated with $10 billion in
health care costs annually.747 We
continue to believe that the existing
measure is appropriate for use in MIPS.
However, when we finalized this
measure for use in MIPS, we noted that,
as with all the cost measures, we would
maintain this measure and update its
specifications as appropriate (83 FR
59766 and 59767). As a part of our
routine measure maintenance, we
reevaluated the STEMI PCI measure
with consideration of input from
interested parties and testing. This
feedback from interested parties
included:
• The patient cohort for the measure
should be expanded, while still
accounting for patient heterogeneity to
increase clinician coverage and capture
more clinically-related services.
• The measure should account for
patients with cardiac arrest and patients
who smoke tobacco to reduce factors
outside of clinician control that
influence measure performance.
In response to this feedback, CMS and
the measure development contractor
conducted additional empirical analyses
747 Amin, Amit P., Patterson, Mark, House, John
A., Giersiefen, Helmut, Spertus, John A., Baklanov,
Dmitri V., Chhatriwalla, Adnan K., Safley, David
M., Cohen, David J., Rao, Sunil V., Marso, Steven.,
‘‘Cost Associated With Access Site and Same-Day
Discharge Among Medicare Beneficiaries
Undergoing Percutaneous Coronary Intervention:
An Evaluation of the Current Percutaneous
Coronary intervention Care Pathways in the United
States,’’ JACC Cardiovasc Interv 10, no. 4 (2017):
342–351.
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and discussed potential modifications
with the measure-specific Clinician
Expert Workgroup. Summaries of these
discussions are available here: https://
www.cms.gov/medicare/quality/valuebased-programs/cost-measures/prior.
Based on these testing results and the
clinician expert input, CMS is
proposing to replace the STEMI PCI
measure with the revised IP PCI
measure. The modifications that we are
proposing to incorporate into the
revised IP PCI measure and our
rationale is outlined as follows.
First, we propose to modify this cost
measure by expanding the patient
cohort based on changes to the
triggering logic. The previous version of
the measure narrowly defined a subset
of STEMI PCI patients to promote
homogeneity of the patient cohort.
However, testing demonstrated that PCI
episodes with and without STEMI
appear to have similar cost profiles and
involve similar clinician types.
Therefore, it is appropriate to expand
the patient cohort in the proposed
revised measure to include episodes
beyond those with STEMI diagnoses,
such as PCI for non-STEMI diagnoses
and PCI without either STEMI or nonSTEMI diagnoses. As such, we would
no longer use ICD–10 diagnosis
information to restrict assessment of
costs under this measure to only
inpatient PCI procedures with a STEMI
diagnosis. This change would increase
the number of clinicians and
beneficiaries for whom this cost
measure would be applicable.
Second, we are proposing to modify
this cost measure to include additional
sub-groups to stratify the patient cohort
based on diagnosis to account for
variations in cost and treatment
pathways for inpatient procedures.
While there are overall similarities
between the diagnosis for inpatient PCI
episodes (that is, STEMI, non-STEMI,
and other inpatient PCI episodes), there
are still expected differences in
observed costs between these cohorts.
This modification would allow us to
assess variation in clinician cost
performance rather than expected cost
differences due to patient diagnoses. We
believe this is appropriate as testing
shows differences in observed episode
costs among STEMI, non-STEMI, and
other inpatient PCI episodes are
neutralized via sub-grouping and risk
adjustment.
Third, we are proposing that the
proposed revised measure excludes
episodes with cardiac arrest and risk
adjusts for patients with a history of
tobacco use to further address
heterogeneity in the patient cohort, as
these cases can result in more complex
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treatment and higher observed costs for
reasons outside of the control of the
attributed clinician. This was supported
by testing on the expanded patient
cohort.
Further detail about the revised IP PCI
measure is included in the measure
specifications documents, which are
available at https://www.cms.gov/
medicare/quality/value-basedprograms/cost-measures.
(viii) Pre-Rulemaking Measure Review
Process
After these extensive measure
development and refinement activities,
we included the six proposed new
episode-based measures and two
modified episode-based measures on
our 2023 Measures Under Consideration
(MUC) List (available for download at
https://mmshub.cms.gov/sites/default/
files/2023-MUC-List.xlsx) to be
considered for potential use in MIPS.
The measures then underwent PRMR
during the 2023–2024 review cycle.
This process involved reviews by the
PRMR Clinician Committee advisory
and recommendation workgroups, as
well as two public comment periods.
More details on the PRMR process are
available at https://p4qm.org/PRMR.
Although we may pursue
endorsement by the consensus-based
entity (CBE), contracted in accordance
with section 1890 of the Act, for the
proposed measures at a later time, we
are not required to use only CBE
endorsed measures in MIPS. We
emphasize that cost measures undergo
extensive review and testing before they
are implemented in MIPS. As described
in section IV.A.4.e.(2)(a)(ii), the
proposed new and revised cost
measures in this proposed rule were
vetted by clinicians, specialty societies,
persons with lived experience,
consensus panels, and the public at
large without going through the CBE
endorsement process. Cost measures are
developed through a rigorous process
with a Clinician Expert Workgroup
providing detailed input on each aspect
of the specifications, reviewing iterative
empirical testing, and considering the
input from persons with lived
experience. The cost measures undergo
field testing during the development
process where MIPS eligible clinicians
can download feedback reports to
review their performance before
measure implementation, and share
input with the developer to help finalize
the measure specifications. In addition,
the proposed new and revised cost
measures in this proposed rule were
reviewed through the pre-rulemaking
process described in this section of this
proposed rule. We continue to believe
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62051
in the strength of the episode-based
measures, proposed for adoption and
modification in this rulemaking, based
on valid and reliable testing results and
extensive review from interested parties
as part of the measure development and
implementation process.
The PRMR Clinician Committee and
Clinician Committee Recommendation
Group reviewed the measure
information, a preliminary analysis of
the measures and their testing
information developed by the CBE, and
public comments. The PRMR Clinician
Committee Recommendation Group met
in January 2024 to discuss the measures
in more detail and vote on their
recommendations for the
appropriateness of these measures’ use
in MIPS. The final result from the
committee’s vote can be: Recommend,
Recommend with conditions, Do not
recommend, or Consensus not reached.
Consensus not reached signals
continued disagreement among the
committee despite being presented with
perspectives from public comment,
committee member feedback and
discussion, and highlights the multifaceted assessments of measures. More
details regarding the CBE PRMR voting
procedures may be found in Chapter 4
of the Guidebook of Policies and
Procedures for Pre-Rulemaking Measure
Review and Measure Set Review at
https://p4qm.org/sites/default/files/
2023-09/Guidebook-of-Policies-andProcedures-for-Pre-RulemakingMeasure-Review-%28PRMR%29-andMeasure-Set-Review-%28MSR%29Final_0.pdf.
The PRMR had mixed
recommendations for the episode-based
measures we are proposing to adopt and
modify (in section IV.A.4.e.(2)(a)(ix)) in
this rulemaking.
The PRMR Clinician Committee
Recommendation Group voted to
‘‘recommend with conditions’’ for the
revised Cataract Removal with IOL
Implantation and IP PCI measures. For
the Cataract Removal with IOL
Implantation measure, while the
committee did not provide or explain its
conditions, they generally suggested
further examination of how
implementation of cost measures may
impact patient outcomes. We plan to
examine patient outcomes in more
detail as part of routine measure
monitoring. For the IP PCI measure, the
committee recommended with the two
conditions: CBE endorsement and
additional testing to gather performance
data over a longer period. As previously
discussed, CBE endorsement is not
required for measures to be adopted and
used in MIPS. We plan to address these
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conditions by monitoring the IP PCI
measure’s performance over time.
The PRMR Clinician Committee
Recommendation Group did not reach
consensus on the CKD, ESRD, Kidney
Transplant Management, Prostate
Cancer, and Respiratory Infection
Hospitalization measures. Overall, there
was varied levels of support of the
measures across the PRMR Clinician
Committee Recommendation Group.
The main concerns raised were related
to scientific acceptability (for example,
testing results suggesting low reliability
for the CKD, ESRD and Kidney
Transplant Management measures),
appropriateness of risk adjustment, and
potential unintended consequences. We
recognize the Recommendation Group’s
concerns, but emphasize the tradeoffs
between accuracy and reliability, as
described in the CY 2022 PFS final rule
(86 FR 65453 through 65456). However,
we did work with the measure
development contractor to conduct
additional testing to address these
concerns. We identified non-substantive
updates to existing outlier exclusions
applied to cost measures that would
address concerns about measure
reliability for the CKD, ESRD, and
Kidney Transplant Management
measures. These adjusted outlier
exclusions substantially improve
reliability and are reflected in Table 60
of this proposed rule. We note that all
the proposed new and revised measures
meet the 0.4 mean reliability threshold
that CMS typically applies for measures’
use in MIPS. The Recommendation
Group also expressed a strong interest in
the measures undergoing CBE
endorsement. As noted above, we may
pursue CBE endorsement of these
measures in the future, but it is not a
requirement for measures to be adopted
and used in MIPS.
The voting results of the PRMR
Clinician Committee Recommendation
Group for the Rheumatoid Arthritis
measure were ‘‘do not recommend.’’
The PRMR final recommendations state
that the Recommendation Group
supported the measure concept, but
ultimately had reservations about its use
in MIPS and concerns about measure
performance. These concerns aligned
with the concerns the Recommendation
Group raised about cost measures
overall, such as concerns around how
cost measures impact patient outcomes.
More information on the PRMR
recommendations is available in the
PRMR 2023 Final Recommendation
Report: https://p4qm.org/sites/default/
files/2024-02/PRMR-2023-MUCRecommendations-Report-Final-.pdf.
We acknowledge the feedback from
the Recommendation Group regarding
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the Rheumatoid Arthritis measure, but
we disagree that the measure should not
be used in MIPS. We agree with the
Recommendation Group’s feedback
regarding the importance of this
measure to assess and address wide
variation in cost performance for
rheumatoid arthritis treatment and
management. Literature states that
rheumatoid arthritis is highly prevalent
and is most common among older
adults.748 749 Given this high prevalence,
rheumatoid arthritis is costly to the
healthcare system and individual
patients, though costs vary based on
treatment regimen.750 Over the past
decade, Medicare costs associated with
disease-modifying treatments have
increased substantially.751 Additionally,
certain treatment choices for
Rheumatoid Arthritis are associated
with increased costs due to adverse
outcomes associated with these choices,
suggesting room for improvement in
cost performance and patient care. For
example, chronic glucocorticoid use
among rheumatoid arthritis patients is
associated with higher health care costs
due to increased occurrence of adverse
events (e.g., developing diabetes or
osteoporosis, cardiovascular events such
as thrombotic stroke, myocardial
infarction, or death).752 753 754 We believe
that the cost of these adverse events are
important to assess in terms of Medicare
spending and impact on the patient
population. In line with these findings,
the Recommendation Group did express
support for the intent of this measure
from a clinician and patient perspective.
748 Centers for Disease Control and Prevention,
‘‘Rheumatoid Arthritis (RA),’’ 2020, https://
www.cdc.gov/arthritis/basics/rheumatoidarthritis.html.
749 Hunter TM, Boytsov NN, Zhang X, Schroeder
K, Michaud K, Araujo AB. Prevalence of
rheumatoid arthritis in the United States adult
population in healthcare claims databases, 2004–
2014. Rheumatol Int. 2017;37(9):1551–1557.
doi:10.1007/s00296–017–3726–1.
750 Hunter et al., Prevalence of rheumatoid
arthritis.
751 Stolshek BS, Wade S, Mutebi A, De AP, Wade
RL, Yeaw J. Two-year adherence and costs for
biologic therapy for rheumatoid arthritis. Am J
Manag Care. 2018;24(8 Spec No.): SP315–SP321.
752 Black, R.J. et al., ‘‘A Survey of Glucocorticoid
Adverse Effects and Benefits in Rheumatic Diseases:
The Patient Perspective,’’ Journal of Clinical
Rheumatology 23, no. 8 (December 2017): 416–420,
https://doi.org/10.1097/rhu.0000000000000585.
753 Wilson, J.C. et al., ‘‘Incidence and Risk of
Glucocorticoid-Associated Adverse Effects in
Patients With Rheumatoid Arthritis,’’ Arthritis Care
& Research, 71, no. 4, (April 2019): 498–511,
https://doi.org/10.1002/acr.23611.
754 Best, J.H. et al., ‘‘Association Between
Glucocorticoid Exposure and Healthcare
Expenditures for Potential Glucocorticoid-related
Adverse Events in Patients with Rheumatoid
Arthritis,’’ Journal of Rheumatology 45, no. 3
(March 2018): 320–328, https://doi.org/10.3899/
jrheum.170418.
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The Recommendation Group stated
that public comments submitted during
the PRMR process suggest the
Rheumatoid Arthritis measure does not
have support by certain rheumatology
associations. However, the comments
received during PRMR did not include
comments from a major rheumatologic
association that has called for the
development of an episode-based
measure for rheumatologists. Members
of this organization were also involved
in the development of the Rheumatoid
Arthritis measure through the
participation in the Rheumatoid
Arthritis Clinician Expert Workgroup.
As described in section
IV.A.4.e.(2)(a)(ii) of this proposed rule,
the Rheumatoid Arthritis episode-based
cost measure was developed with
extensive engagement from interested
parties (that is, clinicians who treat this
disease, persons with lived experience
with Rheumatoid Arthritis, and the
general public) through several
mechanisms including a TEP, public
comment periods, a clinician expert
workgroup, person and family
engagement opportunities, and national
field testing. During the public comment
period for determining which measures
to prioritize for development, we
received feedback from rheumatology
professional societies that they
supported the development of a
Rheumatoid Arthritis measure, as the
current MIPS cost measure inventory
does not include cost measures specific
to care typically provided by
rheumatologists. Additionally, the
Rheumatoid Arthritis Clinician Expert
Workgroup that advised on the measure
specifications included representatives
from 11 professional societies, including
key rheumatology societies.
The Recommendation Group also
expressed concerns with the scientific
acceptability of the Rheumatoid
Arthritis measure. However, national
field testing indicates the measure is
valid and has high reliability at the
group level, with a mean reliability of
0.74, and has moderate reliability at the
individual level with a mean reliability
of 0.52. At both the group and
individual levels, the measure passes
the 0.4 reliability threshold we typically
apply for a cost measure’s use in MIPS,
as discussed in CY 2022 PFS final rule
(86 FR 65453 through 65455).
Additionally, several commenters
expressed concerns with the
Rheumatoid Arthritis measure, such as
the measure could hold clinicians
accountable for costs that they cannot
control (for example, medications), the
risk adjustment methodology may not
account for differences in the patient
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population, and the measure is not tied
directly to patient outcomes. Testing
also indicates that the cost measure
reflects the cost related to treatment
choices and the cost of adverse
outcomes resulting from care and that
the risk adjustment model is working as
intended. There has not been evidence
to suggest that this cost measure would
impact patient outcomes negatively.
More information is available in the
Measure Justification Form available for
download at https://www.cms.gov/files/
zip/2023-wave-5-measure-justificationforms-zip.zip. The Recommendation
Group also acknowledged that the
measure is already specified to adjust
for expected differences in medication
costs based on whether a patient is
enrolled in Medicare Part D (that is,
stratifying the measure by Part D
enrollment), furthering supporting the
scientific acceptability of this measure.
The Recommendation Group
suggested the measure should undergo
endorsement review and receive CBE
endorsement. As discussed previously,
we may pursue CBE endorsement of
these measures in the future, but CBE
endorsement is not a requirement for
measures to be adopted and used in
MIPS.
We are continuing to propose this
measure despite the ‘‘do not
recommend’’ vote from the PRMR
committee because we continue to
believe in the use of this measure based
on the empiric testing results discussed
in this section, including indications of
moderate to high reliability, and
because of the importance of capturing
this clinical area of care. We originally
selected this measure for development
because of its high impact in terms of
patient population, clinician coverage,
and Medicare spending, and the
opportunity to build a chronic condition
measure that would address a condition
not captured by other episode-based
measures in the MIPS cost performance
category. We believe that there is a
strong rationale for including this
measure in the cost performance
category for these same reasons.
lotter on DSK11XQN23PROD with PROPOSALS2
(ix) Proposal To Adopt Six EpisodeBased Measures and Modify Two
Episode-Based Measures
In consideration of the extensive
development, reevaluation, and pre-
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rulemaking review processes described
in sections IV.A.4.e.(2)(a)(i) through
IV.A.4.e.(2)(a)(viii), we are proposing to
make the following updates to the MIPS
cost performance category:
We are proposing to adopt the six new
episode-based measures in the cost
performance category, outlined in Table
58 and described in section
IV.A.4.e.(2)(a)(iii) of this rulemaking,
beginning with the CY 2025
performance period/2027 MIPS
payment year.
We are proposing to replace the
original Routine Cataract Removal with
Intraocular Lens (IOL) Implantation
with the revised Cataract Removal with
Intraocular Lens (IOL) Implantation
measure, with the modifications
described in section IV.A.4.e.(2)(a)(vi) of
this rulemaking, in the cost performance
category beginning with the CY 2025
performance period/2027 MIPS
payment year.
We are proposing to replace the STElevation Myocardial Infarction
(STEMI) Percutaneous Coronary
Intervention (PCI) with the revised
Inpatient (IP) Percutaneous Coronary
Intervention (PCI) measure, with the
modifications described in section
IV.A.4.e.(2)(a)(vii) of this rulemaking, in
the cost performance category beginning
with the CY 2025 performance period/
2027 MIPS payment year.
We invite comments on the proposals
in this section.
(b) Reliability and Case Minimum
In this section of this proposed rule,
we discuss the case minima we are
proposing for the episode-based
measures we are proposing to adopt and
modify (in section IV.A.4.e.(2)(a)(ix)) in
this rulemaking.
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
continued 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
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62053
2022 PFS final rule (86 FR 65453
through 65455). We also noted 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 MIPS eligible clinicians as
possible to be able to have their costs
evaluated by them. Therefore, we
considered 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 and
at § 414.1350(c)(4) a case minimum of
10 episodes for procedural episodebased 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 episode-based
measures in the CY 2022 final rule (86
FR 65453 through 65455).
We examined the reliability of the
eight episode-based measures (six new
and two modified) we are proposing in
this rulemaking, and Table 60 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
case minimum of 20 for each of the
chronic condition and acute impatient
medical condition episode-based
measures. At a 20-episode case
minimum, the mean reliability for the
measures exceeds 0.4 for both groups
and individual clinicians, and the
majority of groups and individual
clinicians meet the 0.4 reliability
threshold. For the procedural measure,
Cataract Removal with Intraocular Lens
(IOL) Implantation, we applied the case
minimum of 10 episodes. At a 10episode case minimum, the mean
reliability for the measure exceeds 0.4
for both groups and individual
clinicians, and all groups and
individual clinicians meet the 0.4
reliability threshold.
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TABLE 60: Percent of TINs and TIN/NPis that Meet 0.4 Reliability Threshold and TIN
and TIN/NPI Mean Reliability
% TINs meeting
0.4 reliability
threshold
Mean reliability
for TINs
Prostate Cancer
Rheumatoid Arthritis
Chronic Kidney Disease
End-Stage Renal Disease
Kidney Transplant
Management
Respiratory Infection
Hospitalization
Cataract Removal with
Intraocular Lens (101)
Implantation
Inpatient (IP) Percutaneous
Coronary Intervention (PC[)
87.4%
95.0%
lotter on DSK11XQN23PROD with PROPOSALS2
(c) 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. This section of this
proposed rule provides context on the
statutory requirements for care episode
20:32 Jul 30, 2024
Jkt 262001
92.5%
91.2%
0.64
95.8%
0.68
100.0%
0.74
100.0%
0.53
100.0%
0.97
100.0%
0.96
100.0%
0.63
100.0%
0.52
88.8%
We believe that calculating these
proposed episode-based measures with
these case minimums would 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 the
chronic condition (CKD, ESRD, Kidney
Transplant Management, Prostate
Cancer, Rheumatoid Arthritis) and acute
inpatient medical condition
(Respiratory Infection Hospitalization
and IP PCI) measures and a case
minimum of 10 episodes for the
procedural measure (Cataract Removal
with IOL Implantation) listed in Table
60. For the IP PCI and Cataract Removal
with IOL Implantation, these case
minimums remain consistent with the
case minimums for the original
measures (that is, STEMI PCI and
Routine Cataract Removal with IOL
Implantation) that are currently in use.
These proposals are also consistent with
our regulation at § 414.1350(c)(4)
through (6). We do not propose to
modify these regulations establishing
the case minima for these types of cost
measures.
We invite comments on the proposals
in this section.
VerDate Sep<11>2014
Mean reliability
for TIN/NPls
0.68
0.74
0.63
0.65
% TIN/NPls
meeting 0.4
reliability
threshold
84.1%
97.3%
82.3%
90.0%
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,
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
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0.62
0.76
0.57
0.59
episode-based measures, we refer
readers to the CY 2023 PFS final rule
(87 FR 70056 through 70057) and CY
2024 PFS final rule (88 FR 79348). The
current operational list and prior
operational lists are available at the QPP
Cost Measure Information page at
https://www.cms.gov/medicare/quality/
value-based-programs/cost-measures/
about.
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 2025
performance period/2027 MIPS
payment year to include six 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.e.(2)(a) of
this proposed rule. We propose
including Respiratory Infection
Hospitalization as a care episode group
and CKD, ESRD, Kidney Transplant
Management, Prostate Cancer, and
Rheumatoid Arthritis as patient
condition groups. These care episode
and patient condition groups serve as
the basis for the six new episode-based
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measures that we are proposing in
section IV.A.4.e.(2)(a)(ix) of this
proposed rule for the cost performance
category. The codes that define these six
care episode and patient condition
groups align with the trigger codes of
the proposed episode-based measures in
section IV.A.4.e.(2)(a)(ix) of this
proposed rule. As described in section
IV.A.4.e.(2)(a)(ii), these specifications
are developed with extensive input from
interested parties.
Additionally, we propose to revise the
care episode group codes listed to align
with the modifications proposed for
Cataract Removal with Intraocular Lens
(IOL) Implantation and Inpatient (IP)
Percutaneous Coronary Intervention
(PCI) measures.
Our proposed revisions to the
operational list are available on our QPP
Cost Measure Information page at
https://www.cms.gov/medicare/quality/
value-based-programs/cost-measures/
about.
We invite public comment on our
proposals in this section.
lotter on DSK11XQN23PROD with PROPOSALS2
(d) Proposed Removal Criteria for MIPS
Cost Measures
Once adopted, cost measures are
retained in the cost performance
category measure inventory, except
when we specifically propose to remove
a measure. We have identified a need to
establish and codify objective criteria
that can be used to inform the removal
of a cost measure from the MIPS cost
performance category. Specifically,
when removing the Simple Pneumonia
with Hospitalization episode-based
measure from the CY 2024 PFS final
rule (88 FR 79348 through 79349), we
confirmed that, unlike the MIPS quality
performance category, the MIPS cost
performance category did not have clear
guidelines for removing a measure
established through the notice-andcomment rulemaking process.
Establishing such criteria would allow
for more consistency in our evaluation
of the cost measures and our decision
on whether to propose that a cost
measure be removed from the MIPS cost
performance category.
Therefore, we are proposing to adopt
the following factors that can be used to
guide the removal of a cost measure:
• Factor 1: It is not feasible to
implement the measure specifications.
• Factor 2: A measure steward is no
longer able to maintain the cost
measure.
• Factor 3: The implementation costs
or negative unintended consequences
associated with a cost measure outweigh
the benefit of its continued use in the
MIPS cost performance category.
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• Factor 4: The measure
specifications do not reflect current
clinical practice or guidelines.
• Factor 5: The availability of a more
applicable measure, including a
measure that applies across settings,
applies across populations, or is more
proximal in time to desired patient
outcomes for the particular topic.
We selected these factors because they
outline instances that we anticipate
based on previous experience where a
cost measure may not be appropriate to
maintain in a program, but not limited
to these instances. We also worked to
align these criteria with the MIPS
quality removal considerations and
criteria outlined in the CY 2019 PFS
final rule (83 FR 59763 through 59765)
and CY 2020 PFS final rule (84 FR
62957 through 62959), where possible,
and, in part, the Hospital Value-Based
Purchasing (HVBP) Program’s removal
factors that are codified in our
regulations at 42 CFR 412.164(c)(3). We
are proposing these specific criteria to
encourage a degree of alignment
between existing measure removal
policies within MIPS and across
Medicare programs, where appropriate,
for cost measures.
There were some instances where
certain removal criteria used by the
MIPS quality performance category and
the HVBP Program would not be
applicable for cost measures and, in
those instances, we are not proposing to
adopt those factors. For example, we did
not propose to adopt the removal
criterion for measures that do not reach
appropriate reporting volumes. This is
because MIPS eligible clinicians do not
separately report or submit data for cost
measures. Instead, we assess and score
cost measures based on administrative
claims data. In addition, our existing
scoring policies for the cost performance
category at § 414.1380(b)(2) already
address situations where there are
insufficient number of MIPS eligible
clinicians meeting the case minimum,
such that the cost measure is not scored.
If we were to determine that a cost
measure would be unlikely to be scored
moving forwards due to insufficient
number of MIPS eligible clinicians
meeting the case minimum, we believe
that the first factor we are proposing
(that is, it is not feasible to implement
the measure specifications) would be
applicable for removal.
We note that these factors are criteria
that would be used as guidance when
considering whether or not to propose
to remove a measure, rather than firm
requirements. Specifically, there could
be instances when a measure meets one
or multiple measure removal factors, but
would be retained in the cost
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62055
performance category regardless,
provided that we determine that the
benefit of keeping the measure in the
cost performance category would
outweigh the benefit of removing it.
Prior to proposing a measure for
removal in accordance with this policy,
we would carefully review the
specifications of the cost measures by
conducting necessary literature reviews,
empirical testing, or other information
gathering.
Additionally, we propose to codify
this proposed measure removal policy
by amending § 414.1350 by adding the
proposed cost removal criteria in
paragraph (e). Specifically, we are
proposing at § 414.1350(e) that CMS
may remove a cost measure from MIPS
based on one or more of the following
factors, provided however CMS may
retain a cost measure that meets one or
more of the following factors if CMS
determines the benefit of retaining the
measure outweighs the benefit of
removing it.
• It is not feasible to implement the
measure specifications.
• A measure steward is no longer able
to maintain the cost measure.
• The implementation costs or
negative unintended consequences
associated with a cost measure outweigh
the benefit of its continued use in the
MIPS cost performance category.
• The measure specifications do not
reflect current clinical practice or
guidelines.
• The availability of a more
applicable measure, including a
measure that applies across settings,
applies across populations, or is more
proximal in time to desired patient
outcomes for the particular topic.
We invite 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 Physician Fee
Schedule (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), the CY 2023
PFS final rule (87 FR 70057 through
70061), and the CY 2024 PFS final rule
(88 FR 79350 and 88 FR 79351). We also
refer readers to 42 CFR 414.1305 for the
definitions of improvement activities
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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 proposing two changes to the
traditional Merit-based Incentive
Payment System (MIPS) and the MIPS
Value Pathways (MVPs) improvement
activities policies for the CY 2025
performance period/2027 MIPS
payment year. We are also proposing at
§ 414.1355 to codify the seven
improvement activity removal factors,
which were adopted in the CY 2020 PFS
final rule (FR 84 62988 through 62990)
to establish criteria used to identify
activities for potential removal or
modification. In addition, we are
proposing changes to the improvement
activities Inventory for the CY 2025
performance period/2027 MIPS
payment year and future years as
follows: adding two new improvement
activities; modifying two existing
improvement activities; and removing
eight previously adopted improvement
activities.
(b) Improvement Activities Inventory
lotter on DSK11XQN23PROD with PROPOSALS2
(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,
including conducting interviews with
highly performing organizations of all
sizes, conducting an environmental scan
to identify existing models, activities, or
measures that met all or part of the
improvement activities performance
category criteria, and reviewing
comments received in the CY 2016 PFS
final rule with comment period (80 FR
71259) and in response to the MIPS and
Advanced Payment Models (APMs)
Requests for Information (RFIs) in
relation to the improvement activities
performance category.
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
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20:32 Jul 30, 2024
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Inventory for the CY 2018 performance
period/2020 MIPS payment year and
future years through guidance.755 In the
CY 2018 Quality Payment Program final
rule (82 FR 53656 through 53659), for
the CY 2019 performance period/2021
MIPS payment year and for future years,
we finalized a formal Annual Call for
Activities process for the addition of
possible new activities and possible
modifications to current activities in the
improvement activities Inventory. An
interested party must submit a
nomination form regarding a new
activity or a modification to an existing
improvement activity (OMB control #
0938–1314) available at
www.qpp.cms.gov during the Annual
Call for Activities.
(ii) Codification of Improvement
Activity Removal Factors
In the CY 2018 Quality Payment
Program proposed rule (82 FR 30056),
we solicited comments on the criteria
that may be used to identify
improvement activities for removal from
the improvement activities Inventory,
citing that, over time, certain
improvement activities should be
considered for removal to ensure the
Inventory is robust and relevant. In the
CY 2020 PFS final rule (84 FR 62568
through 63563), we established seven
removal factors to identify activities for
potential removal or modification from
the Inventory. In this proposed rule, we
are proposing to codify at § 414.1355 the
following existing seven improvement
activity removal factors:
• Factor 1: Activity is duplicative of
another activity.
• Factor 2: There is an alternative
activity with a stronger relationship to
quality care or improvements in clinical
practice.
• Factor 3: Activity does not align
with current clinical guidelines or
practice.
• Factor 4: Activity does not align
with at least one meaningful measure
area.
• Factor 5: Activity does not align
with the quality, cost, or Promoting
Interoperability performance categories.
• Factor 6: There have been no
attestations of the activity for 3
consecutive years.
• Factor 7: Activity is obsolete.
We note that these factors are criteria
that are used as guidance in determining
removal of an activity, but its use is at
CMS discretion. For example, there may
be instances when an activity meets one
755 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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or multiple activity removal factors but
may be retained in the improvement
activities performance category
Inventory, because the benefit of
retaining outweighs the benefit of
removing. We believe that codifying
these removal factors would provide
transparency and alignment with
removals of improvement activities from
the Inventory. We solicit comment on
this proposal.
(iii) 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),
Tables A, B, and C in the Appendix 2
to the CY 2023 PFS final rule (70633
through 70650), and Tables A, B, and C
in the Appendix 2 to the CY 2024 PFS
final rule (88 FR 79965 through 79977)
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=improvementActivities
&py=2024#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 two new
improvement activities, modify two
existing improvement activities, and
remove eight previously adopted
improvement activities for the CY 2025
performance period/2027 MIPS
payment year and future years. We refer
readers to Appendix 2 of this proposed
rule for more details.
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In response to stakeholder feedback,
we are making efforts to streamline the
Inventory over the coming rulemaking
cycles to include only the most robust
and clinically meaningful improvement
activities. The removal and modification
of 10 total activities is an initial step
toward our goal of reducing the size of
the Inventory and helping to ensure that
it includes only the most meaningful
activities that have a clear path to
clinical practice improvement, while
the two proposed new activities would
help fill gaps we have identified in the
Inventory.
Currently, there are 106 finalized
activities in the improvement activities
Inventory, all of which are assigned
either a high or medium weight. When
each of the activities was added, their
requirements reflected clinical practice
standards of the time, addressed areas of
opportunity for fostering clinical
practice improvements, and aligned
with national public health priorities
and CMS programs. The last seven
performance periods have provided
sufficient time for analysis and review
of submissions data to learn how MIPS
eligible clinicians are choosing activities
to report each year. Over the last several
performance years, we have observed
that some activities have not remained
aligned with the latest updates to
clinical practice standards, have not
incorporated the latest national
priorities, and/or have activity
requirements that are no longer
substantive enough to promote a
sufficient level of clinical practice
improvement in today’s health care
environment. Some activities are
continuing to be highly utilized even
though the goals of the improvement
activity have largely been achieved,
with the completion of these
improvement activities contributing
toward a final score without a
corresponding result of ongoing
improvement. Therefore, we are
proposing to remove several of these
improvement activities and to modify
activities to better promote more
meaningful clinical practice
improvement opportunities. In
proposing activities for removal or
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modification, we are considering the
seven adopted improvement activity
removal factors, discussed in the CY
2020 PFS final rule (84 FR 62568
through 63563) and in section
IV.A.4.e.(3)(b)(ii) of this proposed rule.
We refer readers to Table C of
Appendix 2 of this proposed rule for
details on the proposal of these eight
activity removals.
We are proposing two new
improvement activities in the
Population Management subcategory.
One new activity, IA_PM_XX, titled
‘‘Implementation of Protocols and
Provision of Resources to Increase Lung
Cancer Screening Uptake’’ would allow
MIPS eligible clinicians to receive credit
for establishing a process or procedure
to increase rates of lung cancer
screening. While lung cancer is a
leading cause of cancer-related deaths in
the U.S., lung cancer screening is underutilized. This activity aims to increase
this screening and improve associated
outcomes. Another activity, IA_PM_XX,
titled ‘‘Save a Million Hearts:
Standardization of Approach to
Screening and Treatment for
Cardiovascular Disease Risk’’ would
allow MIPS eligible clinicians to receive
credit for implementing a standardized,
evidence-based cardiovascular disease
risk assessment and care management
plan in their practices. This activity
proposal is informed by the results of
the CMS Innovation Center Million
Hearts Model, which included initial
atherosclerotic cardiovascular disease
(ASCVD) assessment as well as
cardiovascular care management, which
were shown to contribute to improved
identification and treatment of patients
at risk for ASCVD and would expand on
the work of this Model by (1) increasing
flexibility in requirements, allowing
more clinician specialties to participate,
along with increased flexibility in risk
assessment to fit the needs of attesting
clinicians and their patient populations;
and (2) requiring the use of structured
documentation of risk factors and
associated treatment plans with the aim
of addressing all risk factors directly.
We are proposing two modifications
to improvement activities focused on
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strengthening the activities to better
promote more meaningful clinical
practice improvement. We are
proposing to modify IA_PM_XX
(formerly IA–ERP_6), titled ‘‘Vaccine
Achievement for Practice Staff—
COVID–19, Influenza, and Hepatitis B,’’
and its validation criteria to revise its
target goals, and to expand its focus and
promote the vaccination of staff for
COVID–19 as well as Influenza and
Hepatitis B. Adjusting the target goals
for this activity would align with the
latest Centers for Disease Control and
Prevention (CDC) recommendations,
and feedback received indicates that
this could increase its utilization.
Additionally, we are proposing to
expand the focus of this activity to
include influenza and hepatitis B to
highlight the importance of staff
vaccination for vaccine-preventable
diseases prevalent today. We are also
proposing to change the activity’s
subcategory, from Emergency Response
& Preparedness to Population
Management, to emphasize that staff
vaccination is a long-term strategy in
reducing morbidity and mortality rates
for these diseases.
We are proposing to modify IA_BE_4,
currently titled ‘‘Engagement of patients
through implementation of
improvements in patient portal,’’ and its
validation criteria to limit the activity to
new implementations of a patient/
caregiver portal and encourage the
measure’s adoption by clinicians who
do not currently utilize this health
information exchange technology. We
are proposing to modify this activity’s
name, description, and its validation
criteria to better align with current
practices. This activity was originally
created during a time of transition to
EHRs to encourage electronic
information exchange. It has become
standard practice to use patient portals;
therefore, the activity is no longer
driving improvement among clinicians
who have already implemented patient
portals.
We are separately proposing to
remove eight existing activities,
presented in Table 61.
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TABLE 61: Improvement Activities Inventory: Proposed Removals
Proposed Removals Titles
Removal Criteria (Factor)
EPA 1 Provide 24/7 Access to MIPS
Factor 7, activity is obsolete
Eligible Clinicians or Groups Who
Have Real-Time Access to Patient's
Medical Record
PM_12 Population empanelment
Factor 7, activity is obsolete
TABLE 61: Improvement
TABLE 61: Improvement
Activities Inventory: Proposed
Activities Inventory: Proposed
Removals
Removals
CC_2 Implementation of
Factor 7, activity is obsolete
improvements that contribute to more
timely communication oftest results
ERP_4 Implementation of a Personal
Factor 7, activity is obsolete
Protective Equipment (PPE) Plan
Factor 7, activity is obsolete
ERP_5 Implementation of a
Laboratory Preparedness Plan
BMH 8 Electronic Health Record
Factor 2, there is an alternative activity
Enhancements for BH data capture
with a stronger relationship to quality
care or improvements in clinical
practice
Factor 1, activity is duplicative
Surgery Anticoagulation Medication
Management
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We refer readers to Appendix 2 of this
proposed rule for details on the
proposed revisions to the improvement
activities Inventory.
(iv) Improvement Activity Scoring and
Reporting Policies
We are proposing two scoring and
reporting policy changes for the
improvement activities performance
category effective for the CY 2025
performance period/2027 MIPS
payment year and subsequent years.
First, we are proposing to eliminate the
weighting of improvement activities.
This would simplify scoring of the
category, as well as complement our
ongoing efforts to refine and improve
the Inventory. In the CY 2017 Quality
Payment Program final rule (81 FR
77177 and 77178), we codified at 42
CFR 414.1380(b)(3) the scoring policies
for the improvement activities
performance category. We established
there that clinicians (except for nonpatient facing MIPS eligible clinicians,
small practices, and practices located in
rural areas and geographic health
professional shortage areas (HPSAs))
receive 10 points for each mediumweighted improvement activity and 20
points for each high-weighted
improvement activity. Non-patient
facing MIPS eligible clinicians, small
practices, and practices located in rural
areas and geographic HPSAs receive 20
points for each medium-weighted
improvement activity and 40 points for
each high-weighted improvement
activity. We established a differentially
weighted model for the improvement
activities performance category with
two categories, medium and high, to
provide flexible scoring and because
there are no nationally recognized
standards or definitions for these
activities (81 FR 28210). Weights were
assigned based on the level of effort and
resources needed to complete each
activity, as well as alignment with
current national public health priorities
and programs such as the Quality
Innovation Network-Quality
Improvement Organization (QIN/QIO).
We have subsequently determined
that the benefit to categorizing activities
as high or medium weighted has greatly
diminished. Over the last several years
of the Quality Payment Program, we
have made refinements and
enhancements to the improvement
activities Inventory by adding new
activities to incorporate newly
identified opportunities for clinical
improvement and by modifying existing
activities to support changes in practice
standards, while also eliminating
activities that are duplicative or that no
longer promote a sufficient level of
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clinical improvement. In this and
subsequent rulemaking cycles, we are
focusing our efforts on streamlining the
Inventory to retain the highest priority
activities that offer the strongest
promotion of clinical practice
improvement. As the Inventory is
streamlined, each retained activity
highlights a unique and vital aspect of
clinical practice improvement, and
therefore every activity would be
considered high priority.
Second, and related to the proposal in
this section of this proposed rule, we are
proposing to further simplify
improvement activity reporting
requirements by reducing the number of
activities to which clinicians are
required to attest to achieve a full score
in the improvement activities
performance category. Currently, MIPS
eligible clinicians are required to report
two high-weighted activities, four
medium-weighted activities, or one
high-weighted and two mediumweighted activities while MVP
participants are currently required to
report one high-weighted activity or two
medium-weighted activities. We are
proposing that MIPS eligible clinicians
who participate in traditional MIPS
would be required to report two
activities. In addition, we are proposing
that MIPS eligible clinicians who are
categorized as small practice, rural, in a
provider-shortage area, or non-patient
facing would now be required to report
one activity. We are proposing that
these policies would be effective for the
CY 2025 performance period/2027 MIPS
payment year and subsequent years.
We are also proposing that MVP
participants would be required to report
one activity. In the CY 2022 PFS final
rule (86 FR 65412 through 65413), we
established that MVP Participants
submitting MVPs report fewer
improvement activities than eligible
clinicians reporting traditional MIPS to
incentivize and support MVP adoption.
We continue to believe that reduced
reporting requirements are necessary to
support the adoption of and reduce the
burden for implementation of MVPs.
We are proposing to lower the number
of activities that MIPS eligible clinicians
are required to complete in order to
obtain a full score to adjust for the
ongoing reduction of activities in the
Inventory as well as to support eligible
clinicians with simplified reporting as
they engage in fewer but more
demanding activities. If the number of
activities in the Inventory is reduced
after this and subsequent rulemaking,
there would be fewer activities from
which to choose. However, the retained
activities in the Inventory from which to
choose would be the highest priority
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activities that offer the strongest
promotion of clinical practice
improvement. This proposal is also
responsive to commenters who, in the
past, have requested that the number of
required activities be reduced and that
more activities be highly weighted (81
FR 77182). The activity removals and
modifications being proposed would
result in an Inventory of activities that
are meaningful, timely, and rigorous.
While decreasing the number of
required activities would simplify
reporting, MIPS eligible clinicians
would still be required to participate in
meaningful activities that yield
significant practice improvement.
We are requesting comments on our
proposals to remove weighting and to
reduce the number of activities to which
clinicians are required to attest to
achieve a full score in the improvement
activities performance category.
Specifically, we are requesting
comments on our proposal to revise
§ 414.1380(b)(3) to read that, beginning
with the CY 2025 performance period/
2027 MIPS payment year, MIPS eligible
clinicians (except for non-patient facing
MIPS eligible clinicians, small practices,
and practices located in rural areas and
geographic HPSAs) receive 20 points for
each improvement activity, while nonpatient facing MIPS eligible clinicians,
small practices, and practices located in
rural areas and geographic HPSAs
receive 40 points for each improvement
activity. Therefore, to receive a score of
40 points, or full credit, MIPS eligible
clinicians (except for non-patient facing
MIPS eligible clinicians, small practices,
and practices located in rural areas and
geographic HPSAs) must report two
improvement activities, while nonpatient facing MIPS eligible clinicians,
small practices, and practices located in
rural areas and geographic HPSAs must
report one improvement activity.
We are also requesting comment on
our proposal to revise § 414.1365(c)(3)
to state that, beginning with the CY
2025 performance period/2027 MIPS
payment year, MVP participants receive
40 points for each improvement activity.
Therefore, to receive a score of 40
points, or full credit, MVP participants
would be required to report one
improvement activity.
(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
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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 42
CFR 414.1375, 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), CY 2023 PFS final rule (87 FR
70060 through 70087), and CY 2024 PFS
final rule (88 FR 79308 through 79312
and 88 FR 79351 through 79365).
(b) Current Definition of CEHRT for the
Quality Payment Program
In the CY 2024 Medicare Physician
Fee Schedule (PFS) final rule (88 FR
79307 through 79312), we finalized
revisions to the definition of CEHRT for
the Quality Payment Program at 42 CFR
414.1305. In the CY 2024 PFS final rule
(88 FR 79309 and 79310), we amended
the definition of CEHRT to be more
flexible in response to changes proposed
by the Office of the National
Coordinator for Health IT (ONC) in the
‘‘Health Data, Technology, and
Interoperability: Certification Program
Updates, Algorithm Transparency, and
Information Sharing’’ (HTI–1) proposed
rule (88 FR 23746 through 23917).
Specifically, we amended our definition
of CEHRT at § 414.1305 to ensure
references to ONC’s definition of Base
EHR at 45 CFR 170.102 and its health
IT certification criteria at 45 CFR
170.315 were responsive to any changes
ONC makes to its definition and criteria
at any time. Instead of requiring that
CEHRT meet only the ‘‘2015 Edition
Base EHR definition,’’ we added that it
also may meet the ‘‘subsequent Base
EHR definition’’ as defined at 45 CFR
170.102. We also amended our
definition of CEHRT to provide that the
CEHRT must be certified to the ONC
health IT certification criteria ‘‘as
adopted and updated’’ in 45 CFR
170.315. This approach is consistent
with the policies subsequently finalized
in the HTI–1 final rule (89 FR 1205
through 1210). For additional
background and information on this
update, we refer readers to the
discussion in the CY 2024 PFS final rule
on this topic (88 FR 79307 through
79312).
In consideration of the updates
finalized in the CY 2024 PFS final rule
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and the HTI–1 final rule, we refer to
‘‘ONC health IT certification criteria’’
throughout this proposed rule where we
previously would have referred to ‘‘2015
Edition health IT certification criteria.’’
These revisions to the definition of
CEHRT in 42 CFR 414.1305 ensure that
updates to the definition of Base EHR in
45 CFR 170.102, and updates to
applicable ONC health IT certification
criteria in 45 CFR 170.315, are
incorporated into the CEHRT definition
without additional regulatory action by
CMS. For ease of reference, Table 65
sets forth the ONC health IT
certification criteria required to meet the
Promoting Interoperability performance
category objectives and measures.
In the CY 2024 PFS final rule (88 FR
79408 through 79414), we also finalized
changes to the CEHRT definition at 42
CFR 414.1305 for Advanced APMs
requiring use of EHR technology
certified under the ONC Health IT
Certification Program that meets the
ONC Base EHR definition at 45 CFR
170.102 and 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. This CEHRT
definition affords 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, rather
than referring to the same criteria
associated with measures in the
Promoting Interoperability performance
category of MIPS (88 FR 79413).
We highlight certain updates to ONC
health IT certification criteria finalized
in the ONC HTI–1 final rule that impact
certification criteria referenced under
the CEHRT definition. ONC adopted the
certification criterion ‘‘Decision Support
Interventions (DSI)’’ in 45 CFR
170.315(b)(11) to ultimately replace the
‘‘clinical decision support (CDS)’’
certification criterion in 45 CFR
170.315(a)(9) included in the Base EHR
definition (89 FR 1236). The finalized
‘‘DSI’’ criterion ensures that Health IT
Modules certified to 45 CFR
170.315(b)(11) must, among other
functions, enable a limited set of
identified users to select (that is,
activate) certain evidence-based
decision support interventions and
Predictive DSI (as the latter term is
defined in 45 CFR 170.102) (89 FR 1241)
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and support user access to specified
‘‘source attributes’’—categories of
technical performance and quality
information—for both evidence-based
and Predictive DSI (89 FR 1236). ONC
further finalized that a Health IT
Module may meet the Base EHR
definition by either being certified to the
existing CDS certification criterion in 45
CFR 170.315(a)(9) or being certified to
the revised DSI criterion in 45 CFR
170.315(b)(11), for the period up to, and
including, December 31, 2024. On and
after January 1, 2025, ONC finalized that
a Health IT Module must be certified to
the DSI certification criterion in 45 CFR
170.315(b)(11) in order to meet the Base
EHR definition, and the adoption of the
CDS certification criterion in 45 CFR
170.315(a)(9) will expire on January 1,
2025 (89 FR 1281).
In the HTI–1 final rule, ONC also
finalized other updates related to ONC
health IT certification criteria referenced
in the CEHRT definition. ONC finalized
January 1, 2026, as the date when
updates discussed below would take
effect; accordingly, health IT developers
must update and provide certified
Health IT Modules to their customers
consistent with the Maintenance of
Certification requirements in 45 CFR
170.402(b)(3) by this date, including the
following updates:
• ONC updated the ‘‘Transmission to
public health agencies—electronic case
reporting’’ criterion in 45 CFR
170.315(f)(5) to specify the use of
consensus-based, industry-developed
electronic standards and
implementation guides (IGs) to replace
functional, descriptive requirements in
the existing criterion on and after
January 1, 2026 (89 FR 1228).
• ONC adopted the United States
Core Data for Interoperability (USCDI)
version 3 in 45 CFR 170.213(b) and
finalized that USCDI version 1 in 45
CFR 170.213(a) will expire on January 1,
2026 (89 FR 1211 and 1223). This
change impacts ONC health IT
certification criteria that reference the
USCDI, including the ‘‘transitions of
care’’ certification criteria in 45 CFR
170.315(b)(1)(iii)(A)(1) and (2), ‘‘clinical
information reconciliation and
incorporation—Reconciliation’’ (45 CFR
170.315(b)(2)(iii)(D)(1) through (3)); and
‘‘view, download, and transmit to 3rd
party’’ (45 CFR 170.315(e)(1)(i)(A)(1))
(89 FR 1214).
• ONC updated the ‘‘demographics’’
certification criterion (45 CFR
170.315(a)(5)), including renaming the
criterion to ‘‘patient demographics and
observations’’ (89 FR 1295 and 1296).
• ONC updated the ‘‘standardized
API for patient and population services’’
certification criterion in 45 CFR
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170.315(g)(10) including finalizing
references to newer versions of
standards referenced in the criterion,
such as the US Core IG 6.1.0 (89 FR
1285) and the SMART App Launch
Implementation Guide Release 2.0.0 (89
FR 1292).
For complete information about the
updates to ONC health IT certification
criteria finalized in the HTI–1 final rule,
we refer readers to the text of the final
rule (89 FR 1192) as well as resources
available on ONC’s website.756
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(c) Potential Future Update of the
SAFER Guides Measure
(i) Background
ONC developed the Safety Assurance
Factors for EHR Resilience Guides
(SAFER Guides) in 2014, and later
updated in 2016. ONC provided the
SAFER Guides, including the High
Priority Practices SAFER Guide, as a
tool to help organizations at all levels
conduct self-assessments to optimize
the safety and use of EHRs.757 In the CY
2022 PFS final rule (86 FR 65475
through 65477), we adopted the SAFER
Guides measure under the Protect
Patient Health Information objective
beginning with the CY 2022
performance period/2024 MIPS
payment year. For the CY 2022
performance period/2024 MIPS
payment year and the CY 2023
performance period/2025 MIPS
payment year, MIPS eligible clinicians
were required to attest to whether they
have conducted an annual selfassessment using the High Priority
Practices SAFER Guide 758 at any point
during the calendar year in which the
performance period occurs, with one
‘‘yes/no’’ attestation statement. MIPS
eligible clinicians were not scored based
on their answer to the attestation, or
their level of implementation of each of
the practices. However, failure to attest
to this measure would result in earning
a score of zero for the Promoting
Interoperability performance category
for failing to meet the minimum
reporting requirements.
In the CY 2024 PFS final rule (88 FR
79354 through 79356), we modified the
SAFER Guides measure. Beginning with
the CY 2024 performance period/2026
MIPS payment year, this modified
measure requires MIPS eligible
clinicians to conduct, and attest ‘‘yes’’
to having completed, an annual self756 For more information, see https://
www.healthit.gov/topic/laws-regulation-and-policy/
health-data-technology-and-interoperabilitycertification-program.
757 https://www.healthit.gov/topic/safety/saferguides.
758 https://www.healthit.gov/sites/default/files/
safer/guides/safer_high_priority_practices.pdf.
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assessment of their CEHRT, using the
High Priority Practices SAFER Guide.
We remind readers that the SAFER
Guides measure only requires
completion of a self-assessment and
does not require MIPS eligible clinicians
to implement fully each of the practices
identified in their self-assessment.
(ii) Status of Updates to SAFER Guides
As summarized in the CY 2024 PFS
final rule (88 FR 79354 through 79356),
we received comments in response to
our proposal to modify the SAFER
Guides measure, including many
comments recommending that we
collaborate with ONC to update the
SAFER Guides, noting that the SAFER
Guides were last updated in 2016 (88 FR
59264). In response to these comments,
we noted that, while the current SAFER
Guides reflect relevant and valuable
guidelines for safe practices with
respect to current EHR systems, we
would consider exploring updates in
collaboration with ONC. We reminded
readers to visit the CMS resource library
website at https://www.cms.gov/
regulations-guidance/promotinginteroperability/resource-library and the
ONC website at https://
www.healthit.gov/topic/safety/saferguides for resources on the content and
appropriate use of the SAFER Guides
(88 FR 59262). We also noted that future
updates to the SAFER Guides would be
provided with accompanying
educational and promotional materials
to notify participants, in collaboration
with ONC, when available (88 FR
59265).
In this proposed rule, we are seeking
to make readers aware that efforts to
update the SAFER Guides are currently
underway. We anticipate that updated
versions of the SAFER Guides may
become available as early as CY 2025.
We would consider proposing a change
to the SAFER Guides measure, as soon
as feasible, potentially beginning in the
CY 2026 performance period/2028 MIPS
payment year to permit use of an
updated versions of the SAFER Guides
at that time. We encourage MIPS eligible
clinicians to become familiar with the
updated versions of the SAFER Guides
when they become available and
consider them as they implement
appropriate EHR safety practices.
(d) Modification of the Definition of
Meaningful EHR User for Healthcare
Providers That Have Committed
Information Blocking
The Department of Health and Human
Services (HHS) final rule ‘‘21st Century
Cures Act: Establishment of
Disincentives for Health Care Providers
That Have Committed Information
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Blocking’’ (hereafter referred to as the
Disincentives final rule), was displayed
for public inspection by the Office of the
Federal Register on June 26, 2024, and
appeared in the Federal Register on July
1, 2024.759 The final rule implements
the provision of the 21st Century Cures
Act specifying that a healthcare
provider, determined by the HHS Office
of the Inspector General (OIG) to have
committed information blocking, shall
be referred to the appropriate agency to
be subject to appropriate disincentives
set forth through notice and comment
rulemaking. In the Disincentives final
rule, we finalized that a MIPS eligible
clinician (other than a qualified
audiologist) will not be considered a
meaningful EHR user in a performance
period if the OIG refers, during the
calendar year of the performance period,
a determination that the MIPS eligible
clinician committed information
blocking as defined at 45 CFR 171.103.
Information blocking, in the case of a
health care provider as defined in 45
CFR 171.102, is a practice that is likely
to interfere with the access, exchange, or
use of electronic health information,
except as required by law or specified
in an information blocking exception in
45 CFR part 171, subpart B, C, or D, and
that the health care provider knows is
unreasonable and is likely to interfere
with access, exchange, or use of
electronic health information.
Furthermore, we finalized to revise the
definition of ‘‘meaningful EHR User for
MIPS’’ at § 414.1305 to state that a MIPS
eligible clinician (other than a qualified
audiologist) is not a meaningful EHR
user for a performance period if the OIG
refers a determination that the MIPS
eligible clinician committed information
blocking, as defined at 45 CFR 171.103,
during the calendar year of the
performance period. We also finalized
amending the requirements at
§ 414.1375(b) to specify that a MIPS
eligible clinician must be a meaningful
EHR user for MIPS (as defined at
§ 414.1305) to earn a score for MIPS
Promoting Interoperability performance
category. Under the final policies, a
MIPS eligible clinician that OIG
determines has committed information
blocking would not be a meaningful
EHR user, and therefore would be
unable to earn a score (instead earning
a score of zero) for the Promoting
Interoperability performance category.
Additional regulatory provisions were
finalized at 45 CFR part 171, subpart J,
759 88 FR 54662. Available at https://
www.govinfo.gov/content/pkg/FR-2024-07-01/pdf/
2024-13793.pdf. See also https://www.healthit.gov/
topic/information-blocking#Disincentives.
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related to the application of
disincentives.
We note that, as finalized, the revised
definition of ‘‘meaningful EHR user for
MIPS’’ at § 414.1305 and the revisions to
§ 414.1375(b) would become effective
when the final rule takes effect on July
31, 2024. For additional background and
information, we refer readers to the
discussion in the ‘‘21st Century Cures
Act: Establishment of Disincentives for
Health Care Providers That Have
Committed Information Blocking’’
proposed rule (88 FR 74957 through
74962), as well as the Disincentives
final rule.
(e) Future Goals of the Promoting
Interoperability Performance Category
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(i) Future Goals With Respect to Fast
Healthcare Interoperability Resources®
(FHIR) APIs for Patient Access
In partnership with ONC, we envision
a future where patients have timely,
secure, and easy access to their health
information through the health
application of their choice. We are
working with ONC to enable this type
of access to health information by
requiring the use of APIs that utilize the
Health Level Seven International® (HL7)
FHIR standard. We work with ONC and
other Federal partners to improve timely
and accurate data exchange, partner
with industry to enhance digital
capabilities, advance adoption of FHIR,
support enterprise transformation efforts
that increase our technological
capabilities, and promote
interoperability.
In the CY 2021 PFS proposed rule (85
FR 50303), we described our future
vision for the Promoting Interoperability
performance category and stated that we
will continue to consider changes that
support a variety of HHS goals,
including supporting alignment with
the 21st Century Cures Act, advancing
interoperability and the exchange of
health information, and promoting
innovative uses of health IT. We also
described plans to continue to align the
Promoting Interoperability performance
category with policies finalized in the
‘‘21st Century Cures Act:
Interoperability, Information Blocking,
and the ONC Health IT Certification
Program’’ final rule (85 FR 25642),
including finalization of a new
certification criterion for a standardsbased API using FHIR, among other
health IT topics.
ONC finalized the HTI–1 final rule (89
FR 1192), effective March 11, 2024, to
further implement the 21st Century
Cures Act, among other policy goals.
ONC finalized revisions to the
‘‘standardized API for patient and
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population services’’ certification
criterion at § 170.315(g)(10). It also
adopted the HL7 FHIR US Core
Implementation Guide (IG) Standard for
Trial Use version 6.1.0 at
§ 170.215(b)(1)(ii), which provides the
latest consensus-based capabilities
aligned with the USCDI version 3 760
data elements for FHIR APIs. The HTI–
1 final rule also created the Insights
Condition and Maintenance of
Certification requirements (Insights
Condition) within the ONC Health IT
Certification Program to provide
transparent reporting on certified health
IT (89 FR 1199). This Insights Condition
will require developers of certified
health IT subject to the requirements to
report on measures that provide
information about the use of specific
certified health IT functionalities by end
users. One such measure calculates the
number of unique individuals who
access their electronic health
information overall and by different
methods such as through a standardized
API for patient and population services
(89 FR 1313 and 1314).
By adopting these new and updated
standards, implementation
specifications, certification criteria, and
conditions of certification, provisions in
the HTI–1 final rule advance
interoperability, improve transparency,
and support the access, exchange, and
use of electronic health information. We
aim to further advance the use of FHIR
APIs through policies in the Promoting
Interoperability performance category to
advance interoperability, encourage the
exchange of health information, and
promote innovative uses of health IT.
We also hope to gain insights into the
adoption and use of FHIR APIs by MIPS
eligible clinicians due to the ONC
Health IT Certification Program’s
Insights Condition. We believe
maintaining our focus on promoting
interoperability, alignment, and
simplification would reduce healthcare
provider burden while allowing
flexibility to pursue innovative
applications that improve care delivery.
For additional background and
information, we refer readers to the
discussion in the ONC HTI–1 final rule
on this topic (89 FR 1192).
(ii) Improving Cybersecurity Practices
The Promoting Interoperability
performance category encourages the
advancement of EHR safety by
promoting appropriate cybersecurity
practices through the Security Risk
Analysis and SAFER Guides measures.
On February 14, 2023, the National
760 https://www.healthit.gov/isa/united-statescore-data-interoperability-uscdi#uscdi-v3.
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Institute of Standards and Technology
(NIST) published updated guidance for
health care entities implementing
requirements of the Health Insurance
Portability and Accountability of 1996
(HIPAA) Security Rule (45 CFR part 160
and subparts A and C of 45 CFR part
164). The guidance, NIST SP 800–66r2,
provides information and resources to
HIPAA-covered entities to improve their
cybersecurity risk practices.761 We also
wish to alert readers of additional HHS
resources and activities regarding
cybersecurity best practices as recently
summarized in an HHS strategy
document that provides an overview of
HHS recommendations to help the
health care sector address cyber
threats.762 HHS has also recently
published a website detailing
recommended cybersecurity
performance goals.763 We intend to
consider how the Promoting
Interoperability performance can
promote cybersecurity best practices for
MIPS eligible clinicians in the future.
(iii) Improving Prior Authorization
Processes
We recently released the CMS
Interoperability and Prior Authorization
final rule, which appeared in the
Federal Register on February 8, 2024
(89 FR 8758). The final rule aims to
enhance health information exchange
and access to health records for patients,
healthcare providers, and payers, and
improve prior authorization processes.
In the final rule, we finalized the
addition of a new measure, the
‘‘Electronic Prior Authorization’’
measure, under the HIE objective for the
MIPS Promoting Interoperability
performance category beginning with
the CY 2027 performance period/2029
MIPS payment year (89 FR 8909 through
8927).
(f) Requirements for the Promoting
Interoperability Performance Category
for the CY 2025 Performance Period/
2027 MIPS Payment Year
(i) Objectives and Measures for the CY
2025 Performance Period/2027 MIPS
Payment Year
For ease of reference, Table 62 lists
the objectives and measures for the
Promoting Interoperability performance
category required for the CY 2025
performance period/2027 MIPS
payment year as revised to reflect the
761 https://csrc.nist.gov/pubs/sp/800/66/r2/final.
762 https://aspr.hhs.gov/cyber/Documents/HealthCare-Sector-Cybersecurity-Dec2023-508.pdf.
763 https://hphcyber.hhs.gov/performancegoals.html.
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policies we will finalize in the final
rule.
BILLING CODE P
TABLE 62: Objectives and Measures for the Promoting Interoperability
Performance Category for the CY 2025 Performance Period/2027 MIPS Payment Year
Measure
e-Prescribing: At least
one permissible
prescription written by
the MIPS eligible
clinician is transmitted
electronically using
CEHRT.
Numerator
Number of
prescriptions in the
denominator
generated and
transmitted
electronically using
CEHRT.
Electronic Prescribing
Query ofPDMP: For
at least one Schedule
II opioid or Schedule
III or IV drug
electronically
prescribed using
CEHRT during the
performance period,
the MIPS eligible
clinician uses data
from CEHRT to
conduct a query of a
POMP for prescription
drug history.
Support Electronic
Referral Loops by
Sending Health
Information: For at
least one transition of
care or referral, the
MIPS eligible
clinician that
transitions or refers
their patient to another
setting of care or
healthcare provider (1)
creates a summary of
NIA (measure is
Yes/No and requires
an affrrmative
attestation to fulfill)
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Health Information
Exchange:TheMIPS
eligible clinician
provides a summary of
care record when
transitioning or
referring their patient
to another setting of
care, receives or
retrieves a summary of
care record upon the
receipt of a transition
or referral or upon the
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Number of
transitions of care
and referrals in the
denominator where
the summary of care
record was created
using CEHRT and
exchanged
electronically
Frm 00469
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Denominator
Number of
prescriptions written
for drugs requiring a
prescription in order
to be dispensed other
than controlled
substances during the
performance period;
or number of
prescriptions written
for drugs requiring a
prescription in order
to be dispensed
during the
performance period.
N/A (measure is
Yes/No and requires
an affrrmative
attestation to fulfill)
Number of transitions
of care and referrals
during the
performance period
for which the MIPS
eligible clinician was
the transferring or
referring clinician
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31JYP2
Exclusion
Any MIPS eligible clinician
who writes fewer than 100
permissible prescriptions
during the performance
period.
Any MIPS eligible clinician
who: 1. is unable to
electronically prescribe
Schedule II opioids and
Schedule Ill and IV drugs in
accordance with applicable
law during the performance
period; or 2. Any MIPS
eligible clinician who does
not electronically prescribe
any Schedule II opioids or
Schedule Ill or IV drugs
during the performance
period.
Any MIPS eligible clinician
who transfers a patient to
another setting or refers a
patient fewer than 100 times
during the performance
period.
EP31JY24.094
Objective
Electronic Prescribing:
Generate and transmit
permissible
prescriptions
electronically
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
Objective
first patient encounter
with a new patient,
and reconciles
summary of care
information from other
healthcare providers
into their EHR using
the functions of
CEHRT
Health Infonnation
Exchange
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Health Information
Exchange
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Mea.'iure
care using CEHRT;
and (2) electronically
exchanges the
summary of care
record.
Support Electronic
Referral Loops by
Receiving and
Reconciling Health
Information: For al
least one electronic
summary of care
record received for
patient encounters
during the
performance period
for which a MIPS
eligible clinician was
the receiving party of
a transition of care or
referral, or for patient
encounters during the
performance period in
which the MIPS
eligible clinician has
never before
encountered the
patient, the MIPS
eligible clinician
conducts clinical
information
reconciliation for
medication, mediation
allergy, and current
problem list.
HIE Bi-Directional
Exchange:
Statement I: I
participate in an HIE
to enable secure, bidirectional exchange
to occur for every
patient encounter,
transition or referral
and record stored or
maintained in the EHR
during the
performance period in
accordance with
applicable law and
policy.
Statement 2: The HIE
that I participate in is
capable of exchanging
information across a
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Numerator
Denominator
Exclusion
Number of
electronic summary
of care records in
the denominator for
which clinical
information
reconciliation is
completed using
CEHR T for the
following three
clinical information
sets: (1) Medication
- Review of the
patient's medication,
including the name,
dosage, frequency,
and route of each
medication; (2)
Medication a11ergy Review of the
patient's known
medication allergies;
and (3) Current
Problem List Review of the
patient's current and
active diagnoses.
Number of electronic
summary of care
records received
using CEHRT for
patient encounters
during the
performance period
for which a MIPS
eligible clinician was
the receiving party of
a transition of care or
referral, and for
patient encounters
during the
performance period
in which the MIPS
eligible clinician has
never before
encountered the
patient.
Any MIPS eligible clinician
who receives transitions of
care or referrals or has
patient encounters in which
the MIPS eligible clinician
has never before
encountered the patient
fewer than 100 times during
the performance period.
NIA (measure is
Yes/No and requires
an affirmative
attestation to fulfill)
NIA (measure is
Yes/No and requires
an affirmative
attestation to fulfi11)
NIA
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Health Information
Exchange
Provider to Patient
Exchange: The MIPS
eligible clinician
provides patients (or
patient-authorized
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Mea.'iure
broad network of
unallilialed exchange
partners including
those using disparate
EHRs, and not
engaging in
exclusionary behavior
when determining
exchange partners.
Statement 3: Tuse the
functions ofCEHRT
to support bidirectional exchange
with an HIE.
Enabling Exchange
Under TEFCA MIPS
eligible clinicians
would attest to the
following:
• Participating as a
signatory to a
Framework
Agreement (a<. that
term is defined by the
Common Agreement
for Nationwide Health
Information
Interoperability as
published in the
Federal Register and
on ONC's website) in
good standing (i.e. not
suspended) and
enabling secure, bidirectional exchange
of information to
occur, in production,
for every patient
encounter, transition
or referral, and record
stored or maintained in
the EHR during the
performance period, in
accordance with
applicable law and
policy.
• Using the functions
of CEHRT to support
bi-directional
exchange of patient
information, in
production, under this
Framework
Agreement.
Provide Patients
Electronic Access to
Their Health
Information: For at
least one unique
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Numerator
Denominator
Exclusion
NIA (measure is
Yes/No and requires
an affirmative
attestation to fulfill)
NIA (measure is
Yes/No and requires
an affinnative
attestation to fulfill)
NIA
Number of patients
in the denominator
(or patient
authorized
representative) who
Number of unique
patients seen by the
MIPS eligible
clinician during the
performance period.
NIA
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Objective
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Objective
representative) with
timely electronic
access lo their health
information.
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Public I Iealth and
Clinical Data
Exchange: The MIPS
eligible clinician is in
active engagement
with a public health
agency or clinical data
registry to submit
electronic public
health data in a
meaningful way using
CEHRT, except where
prohibited, and in
accordance with
applicable law and
practice.
Public Health and
Clinical Data
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Mea.'iure
patient seen by the
MIPS eligible
clinician: 1. The
patient (or the patientauthorized
representative) is
provided timely access
to view on line,
download, and
transmit his or her
health information;
and 2. The MIPS
eligible clinician
ensures the patient's
health information is
available for the
patient (or patientauthorized
representative) to
access using any
application of their
choice that is
configured to meet the
technical
specifications of the
Application
Programming
Interface (API) in the
MIPS eligible
clinician's CEHRT.
Immunization Registry
Reporting: The MIPS
eligible clinician is in
active engagement
with a public health
agency to submit
immunization data and
receive immunization
forecasts and histories
from the public health
immunization
registry/immunization
information system
(IIS).
Electronic Case
Reporting: The MIPS
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PO 00000
Numerator
are provided timely
access to health
information to view
online, download,
and transmit to a
third party and to
access using an
application of their
choice that is
configured meet the
technical
specifications of the
API in the MIPS
eligible clinician's
CEHRT.
Denominator
Exclusion
NIA (measure is
Yes/No and requires
an a:ffrrm.ative
attestation to fulfill)
NIA (measure is
Yes/No and requires
an a:ffrrm.ative
attestation to fulfill)
N/A (measure is
Yes/No and reauires
NIA (measure is
Yes/No and requires
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The MIPS eligible clinician:
I .does not administer any
immunizations to any of the
populations for which data
is collected by its
jurisdiction's immunization
registry or immunization
information system during
the performance period; OR
2.operates in ajurisdiction
for which no immunization
registry or immunization
information system is
capable of accepting the
specific standards required
to meet the CEHRT
definition at the start of the
performance period; OR 3.
Operates in a jurisdiction
where no immunization
registry or immunization
information system has
declared readiness to
receive immunization data
as of 6 months prior to the
start of the performance
period.
The MIPS eligible clinician:
I .Does not treat or diagnose
31JYP2
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Objective
Exchange
Measure
eligible clinician is in
active engagement
with a public health
agency to
electronically submit
case reporting of
reportable conditions.
Numerator
an affirmative
attestation to fulfill)
Denominator
an affirmative
attestation to fulfill)
Public Health and
Clinical Data
Exchange
Public Health Registry
Reporting: (bonus)
The MIPS eligible
clinician is in active
engagement with a
public health agency
to submit data to
public health
registries.
Clinical Data Registry
Reporting: (bonus)
The MIPS eligible
clinician is in active
engagement to submit
data to a clinical data
registry.
Syndromic
Surveillance
Reporting: (bonus)
The MIPS eligible
clinician is in active
engagement with a
public health agency
to submit syndromic
surveillance data from
an uni:ent care setting
Security Risk
Assessment:
Conduct or review a
security risk analysis
in accordance with the
requirements in 45
CFR 164.308(a)(l),
including addressing
the security (to include
encryption) of ePHI
NIA (measure is
Yes/No and requires
an affirmative
attestation to fulfill)
NIA (measure is
Yes/No and requires
an affirmative
attestation to fulfill)
NIA (measure is
Yes/No and requires
an affirmative
attestation to fulfill)
NIA (measure is
Yes/No and requires
an affirmative
attestation to fulfill)
none
NIA (measure is
Yes/No and requires
an aITrrmative
attestation to fulfill)
NIA (measure is
Yes/No and requires
an aITrrmative
attestation to fulfill)
none
NIA (measure is
Yes/No and requires
an affirmative
attestation to fulfill)
NIA (measure is
Yes/No and requires
an affirmative
attestation to fulfill)
none
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Public Health and
Clinical Data
Exchange
Protect Patient Health
Information: Protect
electronic protected
health information
(ePHl) created or
maintained by the
CEHRT through the
implementation of
appropriate technical,
administrntive, and
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Exclusion
any reportable diseases for
which data is collected by
their jurisdiction's
reportable disease system
during the performance
period; OR 2.operates in a
jurisdiction for which no
public health agency is
capable ofreceiving
electronic case reporting
data in the specific
standards required to meet
the CEHRT definition at the
start of the performance
period; OR 3. Operates in a
jurisdiction where no public
health agency has declared
readiness to receive
electronic case reporting
data as of 6 months prior to
the start of the performance
period:
none
31JYP2
EP31JY24.098
Public I lealth and
Clinical Data
Exchange
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Obiective
physical safeguards.
Protect Patient Health
Information
Measure
data created or
maintained by
certified electronic
health record
technology (CEHRT)
in accordance with
requirements in 45
CFR 164.312(a)(2)(iv)
and45 CFR
164.306(d)(3),
implement security
updates as necessary,
and correct identified
security deficiencies
as part of the MIPS
eligible clinician's risk
management process.
SAFER Guides
High Priority Practices
Guide: Conduct an
annual assessment of
the High Priority
Practices Guide
SAFER Guides
(ii) Scoring Methodology for the CY
2025 Performance Period/2027 MIPS
Payment Year
Numerator
NIA (measure is
Yes/No and requires
an affirmative
attestation to fulfill)
Denominator
Exclusion
NIA (measure is
Yes/No and requires
an affirmative
attestation to fulfill)
none
Interoperability performance category
for the CY 2025 performance period/
2027 MIPS payment year.
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Table 63 reflects the scoring
methodology for the Promoting
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62069
TABLE 63: Scoring Methodology for the CY 2025 Performance Period/2027 MIPS
Payment Year
Objective
Maximum
Points
10 points
IO points
Measure
Required/Optional
e-Prescribing
Required
Query of POMP
Required
Support Electronic Referral Loops by Sending Health
15 points
Information
15 points
Support Electronic Referral Loops by Receiving and
Health Information Reconciling Health Information
Required (MIPS
Exchange
eligible clinician's
-ORchoice of one of the
Health Information Exchange Bi-Directional Exchange
30 points
three reporting
-ORoptions)
Enabling Exchange under TEFCA
30 points
Provider to Patient Provide Patients Electronic Access to Their Health
Required
25 points
Exchange
Information
Report the following two measures:
Required
Immunization
Registry
Reporting
25
points
•
• Electronic Case Reporting
Public Health and Report one of the following measures:
Optional
Clinical Data
• Public Health Registry Reporting
5 points (bonus)
Exchange
• Clinical Data Registry Reporting
• Syndromic Surveillance Reporting
Notes: The Security Risk Analysis measure and the SAFER Guides measure are required but will not be assigned
points. Failure to submit an affirmative ("yes") attestation will result in a zero score for the Promoting
Interoperability performance category.
In addition, MIPS eligible clinicians must submit an affirmative ("yes") attestation regarding ONC direct review,
and an affirmative ("yes") attestation that they did not knowingly and willfully take action to limit or restrict the
compatibility or interoperability ofCEHRT, as required by§ 414.1375(b)(3).
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(iii) Exclusion Redistribution
Many required measures have
exclusions associated with them as
shown in Table 62. If a MIPS eligible
clinician believes that an exclusion for
a particular measure applies to them,
they may claim it when they submit
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their data. The maximum points
available in Table 63 do not include the
points that will be redistributed if a
MIPS eligible clinician claims an
exclusion for a specific measure. For
ease of reference, Table 64 shows how
points will be redistributed among the
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objectives and measures specified for
the Promoting Interoperability
performance category for the CY 2025
performance period/2027 MIPS
payment year in the event a MIPS
eligible clinician claims an exclusion for
a given measure.
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Electronic
Prescribing
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TABLE 64: Exclusion Redistribution for CY 2025 Performance Period/2027 MIPS
Payment Year
Objective
Electronic Prescribing
Redistribution if exclusion is
claimed
10 points to HIE objective
10 points toe-Prescribing
measure
15 points to Provide Patients
Electronic Access to Their
Health Information measure
15 points to the Support
Electronic Referral Loops by
Sending Health Information
measure
Measure
e-Prescribing
Query of PDMP
Support Electronic Referral Loops by Sending Health
Information
Health Information
Exchange
Provider to Patient
Exchange
Support Electronic Referral Loops by Receiving and
Reconciling Health Information
-ORHealth Information Exchange Bi-Directional Exchange
-OREnabling Exchange under TEFCA
Provide Patients Electronic Access to Their Health Information
No exclusion
No exclusion
No exclusion
Report the following two measures:
• Electronic Case Reporting
Immunization Registry Reporting
If an exclusion is claimed for
both measures, 25 points are
redistributed to the Provide
Public Health and
Patients Electronic Access to
Clinical Data Exchange
their Health Information
measure
Notes: The Security Risk Analysis measure and the SAFER Guides measure are required but will not be assigned points.
Failure to submit an affirmative ("yes") attestation will result in a zero score for the Promoting Interoperability
performance category.
In addition, MIPS eligible clinicians must submit an affirmative ("yes") attestation regarding ONC direct review, and an
affirmative ("yes") attestation that they did not knowingly and willfully take action to limit or restrict the compatibility or
interoperability ofCEHRT, as required by§ 414.1375(b)(3).
•
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For ease of reference, Table 65 lists
the objectives and measures for the
Promoting Interoperability performance
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category for the CY 2025 performance
period/2027 MIPS payment year and the
associated ONC health IT certification
criteria set forth at 45 CFR 170.315, as
is currently applicable. We refer readers
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to the CY 2024 PFS final rule (88 FR
79307 through 79312) for our discussion
of and amendments to the definition of
CEHRT at § 414.1305.
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TABLE 65: Promoting Interoperability Performance Category Objectives and
Measures and ONC Health IT Certification Criteria
Support electronic referral loops by receiving
and reconciling health information
Health Information
Exchange
(alternative)
Health Information Exchange (HIE BiDirectional Exchange
Safety Assurance Factors for EHR Resilience
Guides SAFER Guides
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Provide patients electronic access to their health
information
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BILLING CODE C
(g) Request for Information (RFI)
Regarding Public Health Reporting and
Data Exchange
Please note, 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.
Respondents are encouraged to
provide complete but concise responses.
This RFI is issued solely for information
and planning purposes; it does not
constitute a Request for Proposal (RFP),
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, CMS is 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
costs associated with responding to this
RFI will be solely at the interested
party’s expense. 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.
Please note that CMS will not respond
to questions about the policy issues
raised in this RFI. CMS may or may not
choose to contact individual responders.
Such communications would only serve
to further clarify written responses.
Contractor support personnel may be
used to review RFI responses.
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
U.S. 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
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reimbursement would be required or
sought. All submissions become U.S.
Government property and will not be
returned. CMS may publicly post the
comments received, or a summary
thereof.
(i) Background
The COVID–19 public health
emergency (PHE) highlighted the
interdependencies of public health and
healthcare, and the importance of
timely, integrated, and interoperable
data exchange across the health
ecosystem to protect the health and
safety of patients, populations, and the
broader public. It also called attention to
the distance between where we are as a
nation, and where we want to be, with
the interoperability of data between
healthcare providers and Public Health
Agencies (PHAs), especially in the event
of a fast-evolving pandemic or other
type of PHE. While many jurisdictions
were able to demonstrate the advantages
of capabilities such as electronic
laboratory reporting for reportable
conditions, surveillance systems to
support case investigations,
immunization registries to track
COVID–19 immunizations, and
syndromic surveillance data for
situational awareness, exchange across
jurisdictions remains inconsistent and,
in some cases, burdensome.
The Promoting Interoperability
performance category plays an
important role in advancing the
exchange of health information between
PHAs and MIPS eligible clinicians,
using certified Health IT Modules that
meet criteria and standards established
under the ONC Health IT Certification
Program. Measures under the Public
Health and Clinical Data Exchange
objective focus on a key set of exchange
capabilities for healthcare providers that
have evolved over time to incorporate
new priorities and technical
approaches. In recent years, we have
also focused on expanding and
strengthening the Public Health and
Clinical Data Exchange objective to
further support the exchange of data
that ultimately supports better patient
and public health outcomes.
Efforts across HHS to advance the
public health information infrastructure
offer opportunities to further evolve the
Promoting Interoperability performance
category. In 2020, Centers for Disease
Control and Prevention (CDC) launched
the Data Modernization Initiative
(DMI),764 a multi-year, billion-plus
dollar public health ecosystem initiative
aimed at moving the public health
764 https://www.cdc.gov/surveillance/datamodernization/.
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community from a siloed and brittle
public health data system to connected,
resilient, adaptable, and sustainable
‘‘response-ready’’ systems capable of
meeting present and future health
challenges. CDC’s vision for public
health data expands on modernization
efforts and focuses on critical
components to advance data for public
health action to equitably protect health,
safety and security.765 To establish
clear, near-term priorities and
milestones that complement that longer
term vision and improve alignment of
data modernization efforts at all levels
of public health and across partners,
CDC released its first Public Health Data
Strategy (Ph.D.S) in 2023 and recently
updated it.766 The Ph.D.S outlines the
data, technology, policy, and
administrative actions essential to
exchange critical core data efficiently
and securely across healthcare and
public health and sets ambitious goals
against which CDC will measure
progress over the next two years.
In tandem with these efforts to chart
a new strategic direction for
improvements to the nation’s public
health infrastructure, evolving technical
approaches are offering opportunities to
automate and expand information
exchange between healthcare providers
and PHAs. ONC is exploring updates to
existing health IT certification criteria
that support current measures in the
Promoting Interoperability performance
category’s Public Health and Clinical
Data Exchange objective, new criteria
that incorporate modern approaches to
exchange, support additional types of
information needed by PHAs, and
criteria that focus on entities receiving
public health data. In the HTI–1 final
rule, ONC finalized updates to the
health IT certification criterion for
electronic case reporting in 45 CFR
170.315(f)(5) incorporating standardsbased approaches to existing functional
requirements in accordance with the
HL7 FHIR Electronic Case Report (eCR)
Implementation Guide (IG) or HL7
Clinical Document Architecture (CDA)
Electronic Initial Case Report (eICR) IG
(89 FR 1226). ONC is also considering
recent recommendations from Federal
advisory committees that have focused
on issues related to public health
interoperability. These include the
Public Health Data Systems Task Force,
which was charged by the Health
Information Technology Advisory
Committee (HITAC) to inform ONC’s
continued collaborative work with CDC
765 https://www.cdc.gov/ophdst/about/advancingdata-for-public-health-action.html.
766 https://www.cdc.gov/ophdst/public-healthdata-strategy/.
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on improving public health data
systems, and in support of CDC’s greater
DMI efforts. In November 2022, the
Public Health Data Systems Task Force
issued recommendations to the
HITAC,767 which included a focus on
new criteria for Health IT modules that
support public health use cases that aim
to standardize technology that receives
information from healthcare providers.
In addition, the CDC Advisory
Committee to the Director (ACD) Data
and Surveillance Workgroup adopted a
report on November 3, 2022, which
addressed standards for public health
data systems and implementing a
certification program for public health
IT as well as other issues.768
We are working in partnership with
the CDC and ONC to explore how the
Promoting Interoperability performance
category could advance public health
infrastructure through more advanced
use of health IT and data exchange
standards. This RFI describes a series of
goals and principles for the Promoting
Interoperability performance category’s
Public Health and Clinical Data
Exchange objective, provides
information about recommended
updates to health IT certification criteria
under consideration that may impact
MIPS eligible clinicians, and seeks
public comment on potential updates
that could help achieve these goals.
(ii) Goals for Public Health Reporting
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As we look toward the future of the
Public Health and Clinical Data
Exchange objective of the Promoting
Interoperability performance category,
we believe decision-making and
prioritization about policy change
should adhere to four goals:
(1) The meaningful use of CEHRT
enables continuous improvement in the
quality, timeliness, and completeness of
public health data being reported;
(2) The meaningful use of CEHRT
allows for flexibility to respond to new
public health threats and meet new data
needs without requiring new and
substantial regulatory and technical
development;
(3) The meaningful use of CEHRT
supports mutual data sharing between
public health and healthcare providers;
and
767 See ‘‘Final Report of the Health Information
Technology Advisory Committee on Public Health
Data Systems’’ https://www.healthit.gov/sites/
default/files/page/2022-11/2022-11-10_PHDS_TF_
Recommendations_Report_Transmittal_Letter_
508.pdf.
768 See ‘‘Data and Surveillance Workgroup
Report,’’ CDC Advisory Committee to the Director
(ACD) Data and Surveillance Workgroup (DSW).
www.cdc.gov/about/pdf/advisory/DSWRecommendations-Report.pdf.
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(4) Reporting burden on MIPS eligible
clinicians is significantly reduced.
These goals inform the questions
provided at the end of this RFI. We
invite public comment on these four
goals.
(iii) Public Health in the ONC Health IT
Certification Program
We continue to collaborate closely
with ONC on policy changes in the ONC
Health IT Certification Program that
either impact existing functionality
reflected in the Promoting
Interoperability performance category’s
measures or represent new capabilities
for MIPS eligible clinicians that could
offer opportunities to achieve our goals
for the Public Health and Clinical Data
Exchange objective in the Promoting
Interoperability performance category.
In this section, we describe specific
topics we are discussing through this
collaboration with ONC.
(1) Making available new capabilities
for exchanging data with PHAs using
the FHIR standard.
Current public health certification
related criteria at 45 CFR 170.315(f)(1)
through (7) generally reference HL7
version 2 and CDA standards that
support single-patient, event-based
submission of data from healthcare
providers to PHAs, such as electronic
transmission of laboratory results (HL7®
Version 2.5.1 Implementation Guide for
Electronic Laboratory Reporting to
Public Health, Release 1 with Errata and
Clarifications) or electronic initial case
reports (HL7 CDA® R2 Implementation
Guide: Public Health Case Report—the
Electronic Initial Case Report (eICR)
Release 2). However, these standards
may not adequately support more
complex data exchange use cases, such
as bulk exchange of data for patients
who received a specific vaccine.
Approaches using FHIR could more
effectively support a wide-scale public
health response and reduce burden of
implementation and maintenance for
data exchange between and among
healthcare providers and PHAs.
Increased availability of FHIR-based
APIs across systems used by PHAs and
healthcare providers could help to
create an ecosystem where PHAs could
use health IT to securely query data
directly from the source, in real time,
based on an initial push of relevant data
when needed. Availability of a FHIR
API in a healthcare provider’s certified
health IT could enable a PHA to query
a MIPS eligible clinician’s CEHRT for
data on any patient with a specific
condition when needed, avoiding the
need for a MIPS eligible clinician to take
action to submit additional information.
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As noted, ONC has already finalized
an update to the electronic case
reporting criterion in 45 CFR
170.315(f)(5), which provides an option
to implement the HL7 FHIR eCR IG as
part of a Health IT Module certified to
the criterion (89 FR 1226). The Public
Health Data Systems Task Force report
stated that ‘‘FHIR-based query may offer
public health additional avenues to
meet the needs of case investigation to
supplement electronic case reporting
and emerging public health threats’’ and
that ‘‘FHIR may support a more focused
and relevant response by providers to
meet public health queries.’’ 769
While FHIR specifications are not
available for all the use cases currently
supported in the public health criteria at
§ 170.315(f)(1) through (7), ONC
continues to evaluate standards
development activities around the use
of FHIR for public health data exchange
that could be incorporated into existing
or new certification criteria, such as
replacing HL7 version 2 and CDA
exchange specifications with a FHIR
approach over time.
(2) Expanding the scope of public
health exchange supported by certified
health IT capabilities.
Existing health IT certification criteria
are linked to measures under the
Promoting Interoperability performance
category, covering use cases from
transmission to immunization registries
and syndromic surveillance, and
electronic case reporting.
The Public Health Data Systems Task
Force report recommended the addition
of several additional certification
criteria reflecting exchange of
information such as birth and death
data, the results of newborn screening
services, and situational awareness.
ONC is monitoring these and other areas
of importance to public health that are
not reflected in the current certification
criteria.
(3) Introducing health IT certification
criteria for systems that receive public
health data.
To date, ONC health IT certification
criteria have been designed with
systems that send data to PHAs in mind,
particularly health IT systems used by
healthcare providers, that exchange data
with PHAs. Misalignment between
certified health IT products and
technology and systems used by PHAs
has created challenges for both
healthcare providers and PHAs,
including reliance on complex
769 See ‘‘Final Report of the Health Information
Technology Advisory Committee on Public Health
Data Systems,’’ https://www.healthit.gov/sites/
default/files/page/2022-11/2022-11-10_PHDS_TF_
Recommendations_Report_Transmittal_Letter_
508.pdf.
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workflows to accommodate nonharmonized and variable data elements
and exchange standards. Inefficiencies
associated with workarounds and
custom processes can lead to further
reductions in data quality,
completeness, consistency, and
interoperability.
The HITAC Public Health Data
Systems Task Force’s report includes a
recommendation that ONC establish
certification criteria for public health
technologies used by Public Health
Authorities in support of their
responsibilities in exchanging data for
public health purposes including those
defined in the existing (f) criteria.770
By establishing minimum functional
capabilities and exchange standards to
both send and receive public health
data, health IT certification criteria
could enhance interoperability across
healthcare providers and PHAs and
provide a long-term mechanism for
alignment as data exchange matures
over time. An expansion of the ONC
Health IT Certification Program to focus
on the receiving side could also bolster
CDC’s public health infrastructure
modernization efforts, described above,
by helping PHAs to align with
healthcare provider data sources using
the same certification criteria and
standards, enabling these entities to
move together on a common timeline for
updating technology requirements.
(iv) RFI Questions
Section 1848(q)(2)(B)(iv) of the Act
requires that we must apply the
requirements under section 1848(o)(2)
of the Act for our assessment of whether
a MIPS eligible clinician is a meaningful
EHR user under the Promoting
Interoperability performance category.
Section 1848(o)(2)(A) of the Act sets
forth three criteria for determining
whether a MIPS eligible clinician is a
meaningful EHR user. One of these
criteria at section 1848(o)(2)(A)(ii) of the
Act requires that the MIPS eligible
clinician demonstrate to the satisfaction
of the Secretary that during the
performance period their CEHRT is
connected in a manner that provides, in
accordance with law and standards
applicable to the exchange of
information, for the electronic exchange
of health information to improve the
quality of health care, such as
promoting care coordination. We
request that commenters consider this
criterion in responding to our questions
for this RFI.
770 Public Health Data Systems Task Force,
Recommendation 23, p. 11 https://
www.healthit.gov/sites/default/files/page/2022-11/
2022-11-10_PHDS_TF_Recommendations_Report_
Transmittal_Letter_508.pdf.
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(1) Questions for Goal #1: Quality,
Timeliness, and Completeness of Public
Health Reporting
The Promoting Interoperability
performance category’s requirement that
MIPS eligible clinicians report the level
of ‘‘active engagement’’ between the
MIPS eligible clinician, and a PHA, as
well as the recently established one-year
limitation in how long a MIPS eligible
clinician may spend in Pre-Production
and Validation for measures under the
Public Health and Clinical Data
Exchange objective, has provided a basis
to broadly incentivize the exchange of
EHR data (87 FR 49339 through 49340).
It has helped to identify barriers that
prevent MIPS eligible clinicians from
moving from Pre-Production and
Validation (Option 1) to Validated Data
Production (Option 2), and it has helped
the development of solutions to
overcome identified barriers. However,
because active engagement reporting
only requires an attestation of whether
a MIPS eligible clinician is reporting
production data or still in the process of
validation, this approach does not allow
us to assess MIPS eligible clinicians on
the comprehensiveness, quality, or
timeliness of the data they provide to
PHAs.
We are considering whether
alternatives to the ‘‘active engagement’’
approach for the measures under the
Public Health and Clinical Data
Exchange objective could better allow
us to assess MIPS eligible clinician’s
performance, meet the data needs of
PHAs, and ultimately allow us to
incentivize increased performance in
these areas. We are interested in how we
could recommend alternatives to the
‘‘active engagement’’ approach in the
context of the evolving technical
infrastructure described above. We are
also interested in the increasing focus
on leveraging FHIR-based data exchange
for public health reporting. Finally, we
are interested in ensuring that any
changes to the active engagement
approach are implemented in a way that
takes advantage of opportunities to
further automate reporting and
minimize administrative burden for
MIPS eligible clinicians.
• To date, all the measures in the
Public Health and Clinical Data
Exchange objective assess whether there
is active engagement between a MIPS
eligible clinician, but they do not
measure the level of performance the
MIPS eligible clinician has achieved in
sending information. Specifically, we
are seeking public comment on the
following questions:
++ Should CMS shift to numerator/
denominator reporting requirements for
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current and future measures in the
Public Health and Clinical Data
Exchange objective? If so, should CMS
prioritize only certain measures for
numerator/denominator reporting?
++ New technical approaches such as
the use of FHIR APIs to support
information exchange with PHAs could
enable PHAs to query healthcare
provider systems directly, after an
initial trigger, rather than relying on a
healthcare provider to take action to
share information. Healthcare providers
having to take action to share
information adds burden to the
healthcare providers and increases the
time it takes for the PHA to receive the
information. How could performance be
measured under approaches such as the
use of FHIR APIs to support information
exchange with PHAs? Would
numerator/denominator reporting be
appropriate under such approaches?
• Continued expansion of the
measures under the Public Health and
Clinical Data Exchange objective to
address different reporting use cases can
incentivize MIPS eligible clinicians to
make more comprehensive information
available to PHAs. We are seeking
public comment on the following
questions:
++ Should CMS continue add
measures under the Public Health and
Clinical Data Exchange objective to
include additional system-specific
requirements (for example, vital
records)? If so, which ones and why?
++ Should CMS create a new measure
for each new type of data or use case
added to the Public Health and Clinical
Data Exchange objective? What are the
risks of including too many measures
under the objective?
++ Alternatively, should CMS explore
ways to group data types and use cases
under a more limited set of Public
Health and Clinical Data Exchange
objective measure? If so, are there
specific scenarios where doing so would
make sense? Anecdotal reports suggest
that some healthcare providers are
attesting to active engagement with
public health for the eCR measure if
they report cases for at least one
notifiable condition (for example,
COVID–19).
++ How can CMS incentivize more
complete electronic case reporting to
PHAs? For example, should CMS
update the measure to require
healthcare providers to meet a certain
threshold for conditions reported?
++ What potential benefit versus
burden trade-offs CMS should consider?
How should CMS account for varying
levels of public health readiness and
capacity for expanding conditions
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reported electronically, such as in rural
areas?
++ What additional levers besides the
Promoting Interoperability performance
category should CMS explore to
improve the completeness of reporting
to public health? How should CMS
work with other partners to incentivize
or require reporting?
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(2) Questions for Goal #2: Flexibility
and Adaptability of the Public Health
Reporting Enterprise
During the COVID–19 and Mpox
PHEs, healthcare providers and PHAs
often had to quickly update their
systems to report case, laboratory, and
vaccination data related to these novel
pathogens and interventions devised in
response to them. In this section, we are
seeking information about how the
Promoting Interoperability performance
category could improve the ability for
public health infrastructure 771 to
quickly adapt to new threats.
Specifically, we are seeking public
comment on the following questions:
• How can the Promoting
Interoperability performance category
support or incentivize response ready
reporting capabilities for healthcare
providers? What, if any, challenges exist
around sharing data with PHAs?
• How can CMS and ONC work with
EHR vendors to ensure that provider
systems are being continually updated
to meet new data needs, such as those
in rural areas?
(3) Questions for Goal #3: Increasing BiDirectional Exchange With Public
Health Agencies
The transition to, and use of more
modern, flexible approaches and
networks that support data exchange
between and across public health and
healthcare is a key goal of HHS efforts
to modernize the public health
information infrastructure. We are
interested in ways that the Promoting
Interoperability performance category
can support this transition. Specifically,
we are seeking public comment on the
following questions:
• Both CDC’s ACD and ONC’s HITAC
have recommended that CDC and ONC
work together to establish certification
criteria for public health technologies
used by PHAs and implement a
coordinated, phased approach to
incentivize and eventually require their
adoption.772 How, if at all, could the
Promoting Interoperability performance
category support or incentivize PHA
771 https://www.cdc.gov/infrastructure/pdfs/
PHIC-Overview.pdf.
772 https://www.healthit.gov/sites/default/files/
page/2023-03/2023-02 08_HITAC_Annual_Report_
for_FY22_508_1.pdf.
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adoption of certified systems and
technologies?
• How can CMS use the Public Health
and Clinical Data Exchange objective to
incentivize early adoption of FHIRbased APIs for public health data
exchange?
• CMS previously finalized the
Enabling Exchange under TEFCA
measure under the HIE objective for
MIPS eligible clinicians to attest to
engaging in health information
exchange. Should CMS introduce an
additional measure to allow MIPS
eligible clinicians to receive credit for
the HIE objective by exchanging public
health data through participation in
TEFCA?
(4) Questions for Goal #4: Significantly
Reduce Reporting Burden for Healthcare
Providers
We are committed to continuing to
reduce reporting burden for healthcare
providers, such as in rural areas, as part
of any updates to the Promoting
Interoperability performance category
undertaken to support the priorities
described above. Specifically, we are
seeking public comment on the
following questions:
• Under the current Public Health
and Clinical Data Exchange objective,
which measures, or other requirements
result in the most administrative burden
for MIPS eligible clinicians?
• How can the Promoting
Interoperability performance category
balance robust Public Health and
Clinical Data Exchange objective
requirements with our desire to reduce
burden on MIPS eligible clinicians?
• How can new technical approaches
to data exchange with PHAs, such as the
use of FHIR APIs, reduce burden for
MIPS eligible clinicians? What are
potential barriers to achieving burden
reduction as these new approaches are
implemented?
f. 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 and, using such
methodology, provide for a final score
for each MIPS eligible clinician. Section
1848(q)(6)(A) of the Act specifies that, to
then determine a MIPS payment
adjustment factor for each MIPS eligible
clinician for an applicable MIPS
payment year, we must compare the
MIPS eligible clinician’s final score for
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62075
the given year to the performance
threshold we established for that same
year in accordance with section
1848(q)(6)(D) of the Act. We refer
readers to section IV.A.4.g.(2) of this
proposed rule for further discussion of
the performance threshold, and our
calculation of MIPS payment
adjustment factors, and our proposals
with respect thereto.
Section 1848(q)(2)(A) of the Act
provides that the Secretary must assess
each MIPS eligible clinician with
respect to four performance categories
in determining each MIPS eligible
clinician’s final score: quality, resource
use (referred to as ‘‘cost’’), clinical
practice improvement activities
(referred to as ‘‘improvement
activities’’), and meaningful use of
certified EHR technology (referred to as
‘‘Promoting Interoperability’’). Section
1848(q)(2)(B) of the Act describes the
measures and activities that must be
specified under each performance
category, including the quality
performance category and cost
performance category. Section
1848(q)(3) of the Act provides that we
must establish performance standards
with respect to the measures and
activities specified under the four
performance categories for a
performance period, considering
historical performance standards,
improvement, and the opportunity for
continued improvement. To calculate a
final score for each MIPS eligible
clinician for the performance period of
an applicable MIPS payment year,
section 1848(q)(5)(A) of the Act
provides that we must develop a
methodology for assessing the total
performance of each MIPS eligible
clinician according to the performance
standards we have established with
respect to applicable measures and
activities specified for each performance
category, using a scoring scale of 0 to
100.
In calculating the final score, we must
apply different weights for the four
performance categories, subject to
certain exceptions, as set forth in
section 1848(q)(5) of the Act and at
§ 414.1380. Unless we assign a different
scoring weight pursuant to these
exceptions, for the CY 2025
performance period/2027 MIPS
payment year, the scoring weights for
each performance category 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.
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For the CY 2025 performance period/
2027 MIPS payment year, we propose to
update our scoring methodologies to
respond to statutory requirements and
impacts observed in performance data.
In this proposed rule, we are proposing
to update our scoring policies consistent
with these goals. Specifically, we
propose to—
• Establish defined topped out
benchmarks for certain topped out
measures for clinicians impacted by
limited measure choice;
• Establish Complex Organization
Adjustment for eCQMs reported by
Virtual Groups and APM Entities.
• Score Medicare CQMs using flat
benchmarks for their first two
performance periods in the program.
• Modify the benchmarking
methodology for scoring measures in the
cost performance category;
• Adopt a new cost measure
exclusion policy;
• Eliminate the weighting of activities
in the improvement activities
performance category; and
• Reduce the number of activities to
which clinicians are required to attest.
We do not propose any changes to
scoring policies for the Promoting
Interoperability performance category.
We refer readers to section
IV.A.4.e.(3)(b)(iv) for discussion of
scoring proposals in the Improvement
Activities performance category.
We refer readers to section
IV.A.4.f.(1)(d) for discussion of
proposals for scoring the cost
performance category.
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(b) 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 the CY 2017, CY
2018, and CY 2019 Quality Payment
Program final rules, the CY 2020, CY
2021, CY 2022, and CY 2023 PFS final
rules, and § 414.1380(b)(1) for our
current policies regarding, among other
things, quality measure benchmarks,
calculating total measure achievement
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 2024 PFS
final rule, we finalized updates to our
scoring flexibilities policy at
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§ 414.1380(b)(1)(vii)(A) (88 FR 79368
through 79369).
(i) Scoring for Topped Out Measures in
Specialty Measure Sets With Limited
Measure Choice
We refer readers to the CY 2017, CY
2018, and CY 2019 Quality Payment
Program final rules, the CY 2023 PFS
final rule (81 FR 77282 through 77287,
82 FR 53721 through 53727, 83 FR
59761 through 59765, and 88 FR 70090
through 70091), and § 414.1380(b)(1)(iv)
for our established topped out measure
scoring policies.
Topped out measures are measures for
which measure performance is
considered so high and unvarying that
meaningful distinctions and
improvements in performance can no
longer be made (81 FR 77136). We
define topped out measures in
§ 414.1305 differently for process
measures and non-process measures. A
topped out process measure means a
measure with a median performance
rate of 95 percent or higher. A topped
out non-process measure means a
measure where the Truncated
Coefficient of Variation is less than 0.01
and the 75th and 90th percentile are
with 2 standard errors. For MIPS
eligible clinicians electing to report on
measures where they expect to perform
well, we anticipated many measures
would have performance distributions
clustered near the top. (81 FR 77282).
Section 1848(q)(3)(B) of the Act requires
that in establishing performance
standards with respect to measures and
activities, we consider, among other
things, the opportunity for continued
improvement. Topped out measures do
not provide an opportunity for
continued improvement nor, more
broadly, do payment adjustments based
on topped out measures incentivize
clinicians to improve their care. As a
result, we finalized policies to identify
and cap the scoring potential of such
measures. Additionally, we established
practices for the removal of such
measures, such as establishing the
topped out measure lifecycle, to
continue to drive quality improvement
in areas where such improvement is
possible and necessary.
The topped out measure lifecycle is
described in the CY 2018 PFS final rule
(82 FR 53721 and 53727). We
established at § 414.1380(b)(1)(iv)(B)
that we would cap scoring for topped
out measures at 7 points in the second
consecutive year that it is identified as
topped out. If a measure has been
identified as topped out for 3
consecutive years after being originally
identified through the benchmarks, such
measure may then be proposed for
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removal through notice-and-comment
rulemaking (83 FR 59761). This
timeline, however, is not fixed. We
noted our concern where removal of
topped out measures would leave
clinicians with fewer than 6 applicable
measures to report and that such
removal in those instances would
impact some specialties more than
others (82 FR 53721). We stated that
consideration for ensuring available
applicable measures would be made
when considering measure removals (83
FR 59763).
The topped out scoring cap and the
topped out measure lifecycle were
established with the intention to drive
continued quality improvement by
providing clinicians with the ability to
plan for optimal quality measurement
and reporting and by providing measure
developers time to develop and submit
alternative measures for use in the
program (82 FR 53727). However, the
pace of measure development has not
matched the rate at which topped out
measures would ideally be removed
under the established topped out
lifecycle policy. Since the CY 2017
performance period/2019 MIPS
payment year, the MIPS final list of
quality measures has decreased from
271 to 198 including the removal of 34
topped out measures that had reached
the end of the topped out measure
lifecycle.
We have received feedback from
interested parties and independently
verified that clinicians reporting
specialty sets in which there is high
presence of topped out measures
receiving the 7-point cap are often
facing both limited measure choice and
limited scoring opportunities. Analysis
of data from the CY 2022 performance
period/2024 MIPS payment year
showed that only 7 percent of quality
measure submissions were for topped
out measures. However, of those
submissions, clinicians representing
five specialties accounted for 54 percent
of the submissions of topped out
measures that contributed to the final
score. When we analyzed the data from
the CY2022 performance period/2024
MIPS payment year, we found that
clinicians in these specialties were
facing limited measure choice, with an
overrepresentation of topped out
measures among their measure
selection. Some such topped out
measures have been retained in the
program to ensure specialists will have
applicable measures in the absence of
more robust measure development.
We acknowledge that certain clinician
specialists have limited measure choice
and that their opportunities to maximize
their MIPS performance score may be
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particularly affected by the current
topped out measure scoring policy. We
appreciate that, as the performance
threshold increases, it may become
more difficult for these clinician
specialists to maximize their MIPS
performance score and secure positive
payment adjustments for reasons
entirely outside of their control,
primarily the topped-out measure
scoring cap. 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. In the CY 2024 PFS final rule,
we finalized the performance threshold
at a score of 75 points for the CY 2024
performance period/2026 MIPS
payment year at § 414.1405(b)(9)(iii) (88
FR 79319). We are proposing in section
IV.A.4.g.(2)(c) to maintain the
performance threshold at 75 points for
the CY 2025 performance year/2027
MIPS payment year. As the number of
topped out measures a clinician reports
increases, a clinician who must report
topped out measures will see their
maximum potential quality performance
category score decrease and the
clinician must score as close to perfect
as possible on the topped out measures
to mitigate the effect of the 7-point cap
on the clinician’s final score. Affected
clinicians face additional difficulty
should they be subject to additional
scoring policies, including reweighting
of performance categories and reporting
quality measures that lack benchmarks.
Reweighting of the Promoting
Interoperability, cost, or both
performance categories increases the
62077
weighting of the quality performance
category in the final score from 30
percent to 55 or 85 percent.
We want to address scoring scenarios
in which limited measure choice
compels clinicians to report topped out
measures with scoring caps consistent
with our desire to facilitate fairer
scoring of all specialties. For this
reason, we are proposing that beginning
with the CY 2025 performance period/
2027 MIPS payment year CMS could
remove the 7-point cap for certain
topped out measures that we would
select based on evaluating the factors
discussed below. This would allow
clinicians who practice in specialties
impacted by limited measure choice to
be scored according to defined topped
out measure benchmarks that do not cap
scores at 7 measure achievement points.
Table 66 is an illustrative example of
the defined topped out measure
benchmark.
TABLE 66: Example Defined Topped Out Measure Benchmark
Measure Achievement Points
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As discussed above, given that
clinicians reporting specialty measure
sets with limited measure choice are
disproportionately hindered by the 7point topped out measure scoring cap,
we would, in accordance with the
methodology discussed below, focus on
identifying the topped out measures
within specialty measure sets which
clinicians with limited measure choice
report. We propose to identify the
measures for which we would apply the
defined topped out measure benchmark
on a yearly basis. Measures receiving
the defined topped out measure
benchmarks would be proposed and
adopted through notice-and-comment
rulemaking concurrent with our
adoption of the MIPS final list of quality
measures.
This proposed performance standard
would aim, for clinicians with limited
measure availability, to continue to
require high performance, but would
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98-99.9%
•'•
not cap scoring potential for exceptional
performers and would offer better
scoring opportunities for those
performing below the median in the
distribution than under our current
policy. Under the proposed topped out
measure benchmarking methodology,
those achieving high performance rates
would be rewarded for high
performance. Scores between 9–9.9
were intentionally left out. We
considered inclusion of scores in the 9th
decile, but ultimately excluded them to
necessitate exceptional clinical quality
performance to achieve maximum
scores. This approach would ameliorate
the challenge of reporting on measures
with a scoring cap while maintaining a
high performance standard for topped
out measures.
In addition to addressing the scoring
limit of the cap, we are also proposing
to address the scoring limits caused by
the heavily skewed distribution of
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6-6.9
.
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topped out measures. Previously,
because median clinician performance
was heavily skewed towards the top of
distribution for many topped out
measures the second highest achievable
decile after the 7th decile may be the
3rd or 4th decile. We therefore propose
to specify a topped out measure
benchmark that would set an even
performance standard. Such a
benchmark policy would facilitate
clinician efforts to improve clinical
quality among clinicians for whom
improvement is still possible. The
proposed distribution would allow
those performing at or above the 97th
percentile to achieve a score of 7.5
measure achievement points or greater
to reward high performance and
encourage clinical quality improvement
for those who perform below the
median.
We propose to conduct an analysis
annually to determine which specialty
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measure sets are impacted by limited
measure choice and which measures
should be subject to the scoring cap
exemption. Our analysis would evaluate
all specialty measure sets by collection
type to assess the impact of limited
measure choice taking into account the
influence of several scoring
considerations including the number of
capped topped out measures, the
number of measures in the specialty set
without historical benchmarks, and the
scoring potential to meet or exceed the
performance threshold. We would then
consider each capped topped out
measure in the corresponding specialty
measure sets on a case-by-case basis for
application of the defined topped out
measure benchmark. Additionally,
annual consideration of which measures
would have the defined topped out
measure benchmark applied would take
into account any changes to the
availability of applicable measures and
changes in the topped out status of
measures that previously had the
defined topped out measure applied. A
measure would not have a defined
topped out measure benchmark applied
until it was identified as topped out for
2 consecutive performance periods, the
point at which point the 7-point cap
would be applied. If suppression of a
measure or removal of a benchmark
impacts a measure scored according to
the defined topped out measure
benchmark, it would not be proposed
again for the application of the defined
topped out measure benchmark and the
performance standard would return to
the standard scoring policy at
§ 414.1380(b)(1)(i).
Measures that are identified as topped
out for 3 consecutive performance
periods may still be proposed for
removal through notice-and-comment
rulemaking and extremely topped out
measures, those with an average mean
performance within the 98th to 100th
percentile range, can also still be
proposed for removal in the next
rulemaking cycle, regardless of whether
or not they are in the midst of the
topped out measure lifecycle (83 FR
59763). If a measure that is scored
according to a defined topped out
measure benchmark later shows
extremely topped out status, it will be
subject to this policy. Any such measure
removal would continue to occur
through notice-and-comment
rulemaking. While we aim to be
responsive to those facing limited
measure choice, we do not believe that
measures with topped out performance
have the same value in the program as
measures that are not topped out, and
they should be scored accordingly in
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instances where doing so does not
unfairly limit a clinician’s scoring
opportunity. We believe these
parameters identify those most
impacted by limited measure choice
while continuing to encourage high
clinical quality measure performance.
This proposal would remain
consistent with our current topped out
measure lifecycle, program goals, and
historical approaches to scoring
scenarios with limited measure choice.
In the CY 2017 Quality Payment
Program final rule, we exempted
measures reported via the CMS Web
Interface from the 7-point measure cap.
The CMS Web Interface requires that
MIPS eligible clinicians submitting via
the CMS Web Interface must submit all
measures included in the CMS Web
Interface (81 FR 77116). Their lack of
ability to select alternative measures
made the application of the 7-point
measure cap inappropriate. Instead, we
finalized a proposal at
§ 414.1380(b)(1)(ii)(A) to use
benchmarks from the corresponding
year of the Shared Saving Program as
the Shared Savings Program
incorporates a methodology for
measures with high performance into
the benchmark (82 FR 53721). The
defined topped out measure benchmark
similarly aims to score clinicians facing
limited measure choice on topped out
measures using a methodology that
adjusts for high performance.
We considered several policy options
to address topped out measure scoring
for clinicians facing limited measure
choice. These included removing all
topped out measures at the end of the
topped out measure lifecycle, exempting
all topped out measures in specialty
measure sets from application of the 7point cap, applying a denominator
reduction for those scoring 7 out of 10
measure achievement points on topped
out measures in specialty measure sets,
and adopting a new reweighting policy
for the quality performance category for
clinicians impacted by limited measure
choice that score below the performance
threshold. These approaches would not
appropriately address the barriers to fair
scoring posed by limited measure
choice, nor would they incentivize and
reward improvement in clinical quality
measure performance. Additionally,
these alternatives would introduce
additional scoring complexity and in
one case, require clinicians’ additional
submission of a reweighting application
to access potential benefits. The
proposed approach of applying defined
topped out measure benchmarks for
certain topped out measures selected in
accordance with the methodology set
forth above avoids the additional
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complexity of the other approaches by
building on historical and current
quality measure scoring policies to
topped out measures that does not
require additional steps to access and is
applicable as we transition to MVPs.
For the reasons stated above, we are
proposing to add § 414.1380(b)(1)(iv)(C)
to state that beginning with the CY 2025
performance period/2027 MIPS
payment year, measures impacted by
limited measure choice as specified in
paragraph (b)(1)(ii)(E) are not subject to
the 7 measure achievement point cap
specified in paragraph (b)(1)(iv)(B). We
propose a conforming change to
§ 414.1380(b)(1)(iv)(B).
We also propose to add
§ 414.1380(b)(1)(ii)(E) to state that,
beginning with the CY 2025
performance period/2027 MIPS
payment year, CMS will publish a list
in the Federal Register of topped out
measures determined to be impacted by
limited measure choice. Measures
included in the list are scored from 1 to
10 measure achievement points
according to defined topped out
measure benchmarks calculated from
performance data in the baseline period
in which a performance rate in the 97th
percentile corresponds to 7.5 measure
achievement points. Accordingly, we
also propose to update
§ 414.1380(b)(1)(ii) to state that except
as provided in paragraphs (b)(1)(ii)(B)
through (F), benchmarks will be based
on performance by collection type, from
all available sources, including MIPS
eligible clinicians and APMs, to the
extent feasible, during the applicable
baseline or performance period. We are
also proposing to make conforming
changes to this section to include a
previous inadvertent omission of
paragraph (b)(1)(ii)(D) in addition the
proposed new exceptions in paragraphs
(b)(1)(ii)(E) and (F) corresponding to
policies discussed in sections
IV.A.4.f.(1)(b)(i) and IV.A.4.f.(1)(c)(i)
respectively.
(ii) Proposed Approach for Determining
Topped Out Measures Impacted by
Limited Measure Choice and Subject to
the Proposed Defined Topped Out
Measure Benchmark and the Proposed
List of Measures That Would Be Subject
to the Defined Topped Out Measure
Benchmark for the CY 2025
Performance Period/2027 MIPS
Payment Year
Under this proposal, we would
annually determine and publish a list of
topped out measures that would have
the 7-point cap removed and be subject
to the proposed defined topped out
measure benchmark. To identify which
topped out measures would be added to
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the list, we would review each specialty
measure set by collection type and
identify if the prevalence of topped out
measures within such a set hinders a
clinician’s ability to successfully
participate in the MIPS quality
performance category. To make such a
determination, we would analyze the
ability of clinicians reporting the
specialty measure sets under review to
reasonably achieve 75 percent of
available quality achievement points
based upon the measures available to
them and program requirements. As
stated, the analysis would be conducted
for each specialty measure set and
would be further broken down by
collection type. At the collection type
level, each measure would be assigned
points based upon the current
benchmarking data: new measures
receive 7 or 5 points based on year in
the program, measures with benchmarks
are given points based upon the highest
decile achievable with a less than
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perfect score (less than 100 percent or
greater than 0 percent for inverse
measures), and measures with no
available historic benchmark are given 0
points. All measure set points would be
added together to get an output of
scoring potential; the Medicare Part B
claims collection type measure sets have
an additional 6 points added to the
output to account for the small practice
bonus. The sum of quality achievement
points for each measure set would be
compared to the analysis threshold,
which is 75 percent of available quality
achievement points, based upon number
of available measures. Any measure sets
that are not able to meet or exceed the
threshold would be flagged as ‘at-risk.’
Additional factors that we would take
into consideration would include
whether or not:
• A measure within the specialty
measure set is considered a cross cutting
measure;
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62079
• A measure within the specialty
measure set is a broadly applicable
measure, which we would consider to
be a measure included in three or more
specialty sets; and
• There are more than ten measures,
by collection type, available in the
specialty set. We request comment on
our proposal to score topped out
measures impacted by limited measure
choice using specialty defined topped
out measures including the proposed
defined topped out measure benchmark.
Table 67 contains the list of measures
that meet the criteria specified above
and for which we are proposing to apply
the defined topped out measure
benchmark for the CY 2025 performance
period/2027 MIPS payment year.
Specialty sets impacted by limited
measure choice include Pathology,
Anesthesiology, Diagnostic Radiology,
and Radiation Oncology.
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TABLE 67: Proposed topped out measures impacted by limited measure choice and subject
to defined topped out measure benchmark for the CY 2025 performance period/2027 MIPS
Payment Year by Specialty Set
Measure ID
Collection Type
eCQM, MIPS CQM
249
Medicare Part B Claims, MIPS CQM
250
Medicare Part B, MIPS CQM
360
MIPSCQM
364
MIPSCQM
395
Medicare Part 8, MIPS CQM
396
MIPSCQM
397
Medicare Part B, MIPS CQM
405
MIPSCQM
406
MIPSCQM
424
MIPSCQM
430
MIPSCQM
436
MIPSCQM
440
MIPSCQM
463
MIPSCQM
477
MIPSCQM
Barret's Esophagus
We request comment on the proposed
approach that we would use each year
to identify the list of measures subject
to the defined topped out measure
benchmark, as well as the proposed list
of topped out measures impacted by
limited measure choice and subject to
defined topped out measure benchmark
for CY 2025 performance period/2027
MIPS Payment Year.
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Radical Prostatectomy Pathology
Reporting
Optimizing Patient Exposure to Ionizing
Radiation: Count of Potential High Dose
Radiation Imaging Studies: Computed
Tomography (CT) and Cardiac Nuclear
Medical Studies
Optimized Patient Exposure to Ionizing
Radiation: Appropriateness: Follow-up
CT imaging for Incidentally Detected
Pulmonary Nodules According to
Recommended Guidelines
Lung Cancer Reporting
(Biopsy/Cytology Specimens)
Lung Cancer Reporting (Resection
Specimens
Melanoma Reporting
Appropriate Follow-up Imaging for
Incidental Abdominal Lesions
Appropriate Follow-up Imaging for
Incidental Thyroid Nodules in Patients
Perioperative Temperature Management
Prevention of Post-Operative Nausea
and Vomiting (PONY) - Combination
Therapy
Radiation Consideration for Adult CT:
Utilization of Dose Lowering
Techniques
Skin Cancer: Biopsy Reporting Time Pathologist to Clinician
Prevention of Post-Operative (POV) Combination Therapy (Pediatrics)
Multimodal Pain Management
(iii) Complex Organization Adjustment
for Virtual Groups and APM Entities
Section 1848(q)(5)(B)(ii)(I) of the Act
requires the Secretary to encourage
MIPS eligible clinicians to report on
applicable quality measures through the
use of Certified Electronic Health
Record Technology (CEHRT) and
qualified clinical data registries. Section
1848(q)(5)(B)(ii)(II) of the Act provides
that the Secretary shall treat such
clinicians as satisfying the clinical
quality measures reporting requirement
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described in section 1848(o)(2)(A)(iii) of
the Act if they report such measures
through the use of such EHR technology
for a given performance period.773 In the
CY 2017 Quality Payment Program final
rule (81 FR 77297), we established the
measure bonus point and bonus cap for
773 Section 1848(o)(2)(A)(iii) of the Act requires a
meaningful EHR user to demonstrate to the
satisfaction of the Secretary that the eligible
professional, among other things, has not
knowingly and willfully taken action to limit or
restrict the compatibility or interoperability of the
certified EHR technology.
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using CEHRT for end-to-end electronic
reporting. We refer readers to
§ 414.1380(b)(1)(v)(B) for our previously
finalized policies regarding measure
bonus points for end-to-end electronic
reporting.
In the CY 2022 PFS final rule, we
finalized our proposal to end measure
bonus points for end-to-end electronic
reporting. We noted that as we move to
MVPs we are simplifying scoring by
removing many of the transition policies
that we established in the early years of
the program in order to develop a
stronger MVP program and promote
alignment between MIPS and MVPs. As
stated in previous rulemaking, we are
working to develop ways to encourage
the use of CEHRT for electronic
reporting without offering measure
bonus points. We stated that we
believed that we could fulfill the
statutory requirement at section
1848(q)(5)(B)(ii)(I) of the Act to
encourage the usage of CEHRT, through
other means. Accordingly, over the past
few years, we have reduced the
availability and limited who can submit
data for the Medicare Part B claims
collection type to only small practices
noting that the Medicare Part B claims
collection type is not an electronic
means of submission.
In the current state, satisfying quality
reporting requirements is not equally
attainable for each MIPS eligible
clinician or entity in the Quality
Payment Program (QPP). As the QPP
and its components (MIPS and
Advanced APMs) has matured, reliance
on and subsequent requirements
necessitating the use of CEHRT have
increased (88 FR 79331). The adoption
of CEHRT has been slower than
anticipated, indicating additional
support for quality reporting may
further support attainment of program
goals while also addressing the observed
and reported challenges faced by
complex entities and organizations
working to meet new requirements.
Virtual Groups and APM Entities may
experience technological barriers to
electronic report, including challenges
aggregating patient data across multiple
TINs, data deduplication, and
interoperability between different health
IT/EHR systems. In the CY 2018 Quality
Payment Program final rule,
commenters indicated that data
aggregation across multiple TINs for
Virtual Groups would be burdensome
for rural and small practices and that
this burden could be prohibitive for
Virtual Groups’ successful participation
in MIPS (82 FR 53610). Commenters
stated that the requirement for Virtual
Groups to aggregate data across the
Virtual Group could be a potential
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barrier for Virtual Group participation
and would not likely occur without
error (82 FR 53610). Commenters noted
that the potential penalty for failure to
overcome technical challenges in data
aggregation was, at that time, a severe 5
percent decrease to the payment
adjustment for TINs that are already
operating on small margins (82 FR
53610). Commenters noted that the
aggregation of data across various TINs
and health IT systems may be
logistically difficult and complex, as
groups and health IT systems have
different ways of collecting and storing
data and stated that data aggregation
across various systems for measures and
activities under each performance
category may not be possible if qualified
registries do not have the option to
assist Virtual Groups (82 FR 53610).
Additionally, commenters stated that
practices already have an issue of not
being able to deduplicate patient data
across different health IT systems/
multiple EHRs and indicated that
Virtual Groups need clear guidelines
regarding how to achieve accurate
reporting (82 FR 53613).
Furthermore, commenters expressed
concerns that registries supporting
Virtual Group reporting would be
opening themselves to potential
penalties as a result of technical
challenges in data aggregation across
multiple EHR systems (82 FR 53610).
The commenters indicated that
registries may not be able to support
Virtual Group reporting due to legal and
operational complexity. Certain
registries have internal data governance
standards, including patient safety
organization requirements, that they
must follow when contracting with
single TIN participants that may
complicate their ability to support
Virtual Group reporting due to
necessary legal agreements between solo
practitioners and small groups within a
Virtual Group (82 FR 53611).
Commenters requested that CMS
provide guidance to registries regarding
how to handle data sharing among
Virtual Groups with respect to patient
safety organization requirements and
provide guidance regarding the
expectations for registries supporting
virtual group reporting (82 FR 53611).
APM Entities are organizations that
participate in CMS’s various APMs,
including the Medicare Shared Savings
Program and CMS Innovation Center
models. APM Entities face similar
organizational challenges reporting
eCQMs because of their complex
structures, new and innovative
partnerships under their respective
APMs, and utilization of multiple EHR
technologies (88 FR 79097). For ACOs
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62081
in the Shared Savings Program, and
ACOs and other large organizations in
CMS Innovation Center models, these
issues are further exacerbated by scale
and patient volume, as discussed in
more detail further in this section. In the
CY 2023 PFS proposed rule,
commenters noted issues for ACOs
participating in the Shared Savings
Program reporting all payer/all patient
eCQMs/MIPS CQMs related to meeting
all-payer data requirements, data
completeness requirements, and data
aggregation (87 FR 69837). ACOs also
noted the financial burden of
aggregating, deduplicating, and
exporting eCQM data across multiple
TINs and EHRs (88 FR 79097). As
summarized in the CY 2024 PFS final
rule, commenters noted that the current
state of data standards and
interoperability will not yet fully enable
Shared Saving Programs ACOs to meet
the eCQM reporting requirements
successfully and encouraged CMS to
continue working with providers to
facilitate the transition to all-payer/allpatient measures even as/if the provider
or ACO chooses to report Medicare
CQMs (88 FR 79107). In the CY 2024
PFS final rule (88 FR 79098), we stated
that our long-term goal continues to be
to support Shared Savings Program
ACOs in the adoption of all payer/all
patient measures and transition to
digital quality measurement reporting.
These challenges also can be faced by
other large APM Entities participating in
CMS Innovation Center models.
Additionally, APM Entities in CMS
Innovation Center models, regardless of
size, are participating in innovative
payment and delivery designs through
which they may forging new
partnerships among different providers
and provider types to provide care to
attributed beneficiaries to meet the
APM’s care delivery requirements. For
example, the Making Care Primary
(MCP) Model includes several payment
innovations to support participants in
delivering advanced primary care and
aims to strengthen coordination
between patients’ primary care
clinicians, specialists, social service
providers, and behavioral health
clinicians, ultimately leading to chronic
disease prevention, fewer emergency
room visits, and better health outcomes.
The model will operate through three
progressive tracks, with the first track
being designed for organizations with
no prior value-based care experience.
Additionally, the model includes State
partnerships and multi-payer alignment
objectives. Participation in this model
will involve forming new relationships
to provide whole-person care to
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beneficiaries, which is likely to
necessitate bridging data across multiple
technologies and involve new and
complex administrative burdens in the
provision of this advanced primary care.
Based on our assessment and
understanding over the past 2 years, we
have learned that there are complexities
and challenges for Virtual Groups and
APM Entities in adopting all-payer/allpatient collection types, and as a result,
the widespread adoption of the allpayer/all patient collection types
requires further time and support. We
have come to understand that further
support is needed for complex
organizations. As an example, Shared
Saving Program ACOs provide a high
volume of services, particularly those
related to preventative screening
measures. An internal analysis of
performance year 2022 submission data
indicates that Shared Savings Program
ACOs reported on 33 times more
denominator eligible patients for eCQM
001—Diabetes: HbA1c Poor Control
(>9%), 53 times more denominator
eligible patients for eCQM 134—
Preventative Care and Screening:
Screening for Depression and FollowUp Plan, and 25 times more
denominator eligible patients for eCQM
236—Controlling High Blood Pressure
than other MIPS reporters. In
performance year 2022, one ACO
reported on over 700,000 denominator
eligible beneficiaries for a single eCQM.
The requirement to aggregate patient
data collected across multiple health
records into a single data stream before
sending to CMS poses administrative
challenges and the need for additional
resources for Virtual Groups and APM
Entities, including Shared Savings
Program ACOs. Additionally, data
deduplication is resource intensive and
requires the development of new
workflows to ensure accuracy.
Stakeholders have also noted that
patient files exist in multiple, disparate
EHRs since each EHR system collects
and stores data differently. This is
important as moving to reporting
eCQMs requires building new processes
to fill data gaps and ensure data
accuracy and causes participants often
to customize workflows for data
processing, such as using Quality
Reporting Document Architecture
(QRDA) I (individual patient) and
QRDA III (measured entity’s aggregate)
data submission approaches for quality
reporting. EHR vendors have also
expressed concerns regarding the need
for more time to develop new features
that can facilitate eCQM reporting
processes. Some interested parties have
also voiced concerns that clinician
specialty or patient population could
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yield lower quality scores when
reporting eCQMs and create resistance
to switching to this collection type.
We noted in the CY 2024 PFS final
rule that a few commenters agreed that
Medicare CQMs would address most of
ACOs’ concerns regarding all payer/all
patient reporting in the Shared Saving
Program, such as difficulties reporting
for those ACOs with a higher proportion
of specialty practices or groups with
multiple EHRs, beneficiaries with no
primary care relationship, and
shouldering a greater burden when
matching and deduplicating patient
records (88 FR 79101). Other
commenters noted Medicare CQMs
reduce concerns about specialists
reporting on primary care focused
measures. Commenters shared that
Medicare CQMs were responsive to
several key concerns raised by Shared
Savings Program ACOs regarding
feasibility of implementing eCQMs/
MIPS CQMs, including equity concerns
(88 FR 79101). However, we maintain
that consistent with section
1848(q)(5)(B)(ii)(I) we support and
encourage providers as they perform
any necessary bridging of data across
multiple technologies, which can
involve new and complex
administrative burdens.
To account for the organizational
complexities faced by Virtual Groups
and APM Entities, including ACOs in
the Shared Savings Program, we are
proposing to establish a Complex
Organization Adjustment beginning in
the CY 2025 performance period/2027
MIPS Payment Year. Virtual Group and
APM Entities would receive one
measure achievement point for each
submitted eCQM that meets the data
completeness at § 414.1380(b)(1)(iii) and
case minimum requirements at
§ 414.1340. Each reported eCQM may
not receive more than 10 measure
achievement points and the total
achievement points (numerator) may
not exceed the total available measure
achievement points (denominator) for
the quality performance category. The
Complex Organization Adjustment for a
Virtual Group or APM Entity may not
exceed 10 percent of the total available
measure achievement points in the
quality performance category. The
adjustment would be added for each
measure submitted at the individual
measure level.
Adding one point for each eCQM
would help complex organizations to
overcome barriers to reporting eCQMs
while not masking overall quality
performance. By limiting the Complex
Organization Adjustment to Virtual
Groups and APM Entities, we can limit
scoring inflation and target this
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intervention to those facing challenges
to eCQM implementation. Moreover,
while acknowledging the Complex
Organization Adjustment is a
recognition of current challenges to
eCQM reporting we believe that
adoption of the Fast Healthcare
Interoperability Resources (FHIR)
Application Programing Interface (API)
would reduce or eliminate the barriers
posed by organizational complexities to
eCQM reporting and will revisit and end
this Adjustment as uptake of FHIR API
increases, requirements surrounding the
use of FHIR API are established, or other
barriers posed by organizational
complexity are otherwise reduced. This
Adjustment differs from the previous
end-to-end electronic reporting bonus in
that it does not merely award measure
achievement points for reporting but
provides an adjustment for clinicians
facing complex organizational barriers
for adopting the eCQM collection type.
We propose to add
§ 414.1380(b)(1)(vii)(C) to provide that,
beginning in the CY 2025 performance
period/2027 payment year, a Virtual
Group and an APM Entity receives one
measure achievement point for each
eCQM submitted that meets the case
minimum requirement at paragraph
(b)(1)(iii) and the data completeness
requirement at § 414.1340. Each
measure may not to exceed 10 measure
achievement points. The total
adjustment to the Virtual Group or APM
Entity’s quality performance category
score under this paragraph may not
exceed 10 percent of the total available
measure achievement points.
Accordingly, we proposed to update
§ 414.1380(b)(1)(vii) to state a MIPS
eligible clinician’s quality performance
category score is the sum of all the
measure achievement points assigned
for the measures required for the quality
performance category criteria plus the
measure bonus points in paragraph
(b)(1)(v) and Complex Organization
Adjustment in paragraph (b)(1)(vii)(C).
The sum is divided by the sum of total
available measure achievement points.
The improvement percent score in
paragraph (b)(1)(vi) is added to that
result. The quality performance category
score cannot exceed 100 percentage
points.
We request comment on our proposal
to implement a Complex Organization
Adjustment for Virtual Groups and APM
Entities, including ACOs in the Shared
Savings Program.
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(c) Scoring the Quality Performance
Category Through MIPS for ACOs in the
Shared Saving Program.
(i) Proposal To Score for Shared Savings
Program ACOs Reporting Medicare
CQMs Using Flat Benchmarks
In section III.G.4.c.2.c of this
proposed rule we are proposing to score
Shared Savings Program ACOs reporting
Medicare CQMs in the APP Plus quality
measure set using flat benchmarks for
their first two performance periods in
MIPS. Consistent with this discussion,
we are proposing to add
§ 414.1380(b)(1)(ii)(F) to state that
beginning in the CY 2025 performance
period/2027 MIPS payment year,
measures of the Medicare CQM
collection type would be scored using
flat benchmarks for their first two
performance periods in MIPS. We
request comment on our proposal to
score Medicare CQMs using flat
benchmarks for their first two
performance periods in MIPS.
(d) Cost Performance Category Score
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(i) Scoring the Cost Performance
Category Background
As discussed previously, to calculate
a final score for each MIPS eligible
clinician for the performance period of
an applicable MIPS payment year,
section 1848(q)(5)(A) of the Act requires
that we must develop a methodology for
assessment of the total performance of
each MIPS eligible clinician, according
to the performance standards we have
established in accordance with section
1848(q)(3) of the Act, with respect to
applicable measures and activities
specified for each performance category.
For the final score, we must use a
scoring scale of 0 to 100.
We refer readers to § 414.1380(b)(2)
for our policies regarding scoring for the
cost performance category and to
previous rules where these policies
were finalized, including the CY 2017
Quality Payment Program final rule (81
FR 77308 through 77311), the CY 2018
Quality Payment Program final rule (82
FR 53748 through 53752), the CY 2019
PFS final rule (83 FR 59856), the CY
2021 PFS final rule (85 FR 84877
through 84880), the CY 2022 PFS final
rule (86 FR 65507 through 65509), the
CY 2023 PFS final rule (87 FR 70091
through 70093), and the CY 2024 PFS
final rule (88 FR 79369 through 79373).
We are proposing to: (1) modify the
benchmark methodology for scoring
measures specified for the cost
performance category beginning with
the CY 2024 performance period/2026
MIPS payment year; and (2) adopt a new
cost measure exclusion policy beginning
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with the CY 2025 performance period/
2027 MIPS payment year.
(ii) Benchmark Methodology for Scoring
the Cost Performance Category
(A) Background on Methodology for
Scoring the Cost Performance Category
Under § 414.1350(a), we specify cost
measures for a performance period to
assess the performance of MIPS eligible
clinicians on the cost performance
category. Under § 414.1380(b)(2), we
score each MIPS eligible clinician 774 on
each cost measure attributed to them in
accordance with § 414.1350(b) so long
as the MIPS eligible clinician meets the
minimum case volume specified under
§ 414.1350(c) to be scored on that cost
measure. Cost performance category
measures are attributed to MIPS eligible
clinicians through, and scored based on,
claims data; we do not require MIPS
eligible clinicians to submit any
additional data on cost measures to
CMS (§ 414.1325(a)). We have codified
our cost performance category scoring
policies at § 414.1380(b)(2).
Specifically, we finalized at
§ 414.1380(b)(2) that we will score each
cost measure attributed to a MIPS
eligible clinician (meeting or exceeding
the minimum case volume) by assigning
achievement points between one and
ten based on the MIPS eligible
clinician’s performance on the cost
measure during the performance period
compared to the measure’s benchmark.
We award the achievement points
(including partial points) based on
which benchmark decile range the MIPS
eligible clinician’s performance on the
measure is between. The MIPS eligible
clinician’s cost performance category
score (to be added to the final score) is
the sum (not to exceed 100 percent) of:
(1) the total number of achievement
points earned by the MIPS eligible
clinician divided by the total number of
available achievement points; and (2)
the cost improvement score, as
determined under § 414.1380(b)(2)(iv)
(§ 414.1380(b)(2)(iii)). We will not
calculate a cost performance category
score if the MIPS eligible clinician is not
attributed any cost measures for the
performance period because the MIPS
eligible clinician has not met the
minimum case volume as specified
under § 414.1350(c) for any of the cost
774 As noted previously, the term MIPS eligible
clinician is defined in § 414.1305 as including a
group of at least one MIPS eligible clinician billing
under a single tax identification number. A cost
measure therefore may be attributed to a group that
includes at least one MIPS eligible clinician and the
group may therefore be scored on the cost
performance category as a whole. We refer readers
to our policies governing group reporting and
scoring under MIPS as set forth in § 414.1310(e).
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62083
measures or a benchmark has not been
created for any of the cost measures that
would otherwise be attributed to the
MIPS eligible clinician
(§ 414.1380(b)(2)(v)).
As set forth in § 414.1380(b)(2)(i), we
determine cost measure benchmark
ranges based on all MIPS eligible
clinicians’ performance on each
attributed cost measure during the
performance period. We determine a
benchmark for a cost measure only if at
least 20 MIPS eligible clinicians are
attributed and meet the minimum case
volume for that measure, as specified
under § 414.1350(c). If we cannot
determine a benchmark for a cost
measure because an insufficient number
of MIPS eligible clinicians were
attributed the measure (that is, less than
20 MIPS eligible clinicians meet the
minimum case volume), then we will
not assign any score for the measure for
any MIPS eligible clinician
(§ 414.1380(b)(2)(i) and (v)). We refer
readers to our prior rulemakings,
including the CY 2017 Quality Payment
Program final rule (81 FR 77308 through
77311), for detailed discussion of our
previously finalized policies for
determining a benchmark for each cost
measure and then assignment of
achievement points based on
comparison of a MIPS eligible
clinician’s performance to that
established benchmark.
Specifically, under our current
scoring policy at § 414.1380(b)(2) and
benchmark methodology, MIPS eligible
clinicians with the lowest average cost
per episode or per beneficiary would be
in the top decile (Decile 10) and receive
the highest number of available
achievement points (10). On the other
end of the spectrum, MIPS eligible
clinicians with the highest average cost
per episode or per beneficiary would be
in the bottom decile (Decile 1) and
receive the lowest number of
achievement points (1). More
information about how average cost per
beneficiary or per episode are calculated
and translated to MIPS achievement
points is available in the 2023 MIPS
Cost User Guide.775
Table 68 provides an example of
using benchmark deciles along with
partial achievement points to assign
achievement points for a sample cost
measure under our current
methodology. The following formula is
used to determine the number of partial
points awarded to the MIPS eligible
clinician:
Benchmark Decile # + [(measure score,
expressed as a dollar amount¥bottom
775 https://qpp.cms.gov/resources/document/
fac61617-20ef-4d31-9f0f-4a0e76620ca3.
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of benchmark decile range)/(top of
benchmark decile range¥bottom of
benchmark decile range)] = Cost
Measure Achievement Points.776
TABLE 68: Example of Using Benchmark Deciles and Partial Points to Assign
Achievement Points for Performance on the Screening/Surveillance Colonoscopy Cost
Measure
Cost per Episode
$1330.65-$1126.35
$1126.34-$1062.93
$1062.92-$1025.75
$1025.74-$997.78
$997.77-$969.73
$969.72-$940.03
$940.02-$904.83
$904.82-$860.44
$860.43-$779 .69
$779.68 and lower
Percentile
99 th
90 th
80 th
70 th
60 th
50 th
40 th
30th
20 th
10th
Possible Points
1.0-1.9
2.0-2.9
3.0-3.9
4.0-4.9
5.0-5.9
6.0-6.9
7.0-7.9
8.0-8.9
9.0-9.9
10
In the CY 2021 PFS final rule (85 FR
84877 through 84880), we finalized at
§ 414.1350(d)(4) the weight of the cost
performance category to be 20 percent of
the MIPS final score for the 2023 MIPS
payment year and at § 414.1350(d)(5)
the weight of the cost performance
category to be 30 percent of the MIPS
final score for the 2024 MIPS payment
year and each subsequent MIPS
payment year. We noted that such an
approach would allow us to reach the
statutorily required weight of 30 percent
by the 2024 MIPS payment year (see
section 1848(q)(5)(E)(i)(II) of the Act)
while reducing the impact of
experiencing an increase in the weight
of the cost performance category too
much in any one year and providing
clinicians with an eased gradual and
incremental transition starting with the
2023 MIPS payment year.
Since, MIPS eligible clinicians have
raised concerns about cost performance
category scoring having a negative
impact on their final MIPS score.
Multiple factors have likely contributed
to clinician concerns.
First, there has been an increase in
weight for the cost performance category
over time. Particularly, due to the
COVID–19 Public Health Emergency
(PHE) which ended on May 11, 2023,
we reweighted the cost performance
category’s score to zero percent of the
final score for many MIPS eligible
clinicians. Specifically, we announced
on April 6, 2020 that, due to the
COVID–19 PHE, we would apply our
extreme and uncontrollable
circumstances reweighting policies
described under § 414.1380(c)(2)(i) to
MIPS eligible clinicians nationwide and
extend the deadline to submit an
application for reweighting the quality,
cost, improvement activities or
Promoting Interoperability reporting
categories for the CY 2019 performance
period/2021 MIPS payment year (85 FR
19277 and 19278). Also, for the CY 2020
performance period/2022 MIPS
payment year and the CY 2021
performance period/2023 MIPS
payment year, we extensively applied
our reweighting policies, described
under § 414.1380(c)(2)(i), to MIPS
eligible clinicians nationwide due to the
COVID–19 PHE.777 778 As a result, the
CY 2022 performance period/2024 MIPS
payment year was the first MIPS
payment year that the cost performance
category score generally constituted 30
percent of MIPS eligible clinicians’ final
scores (section 1848(q)(5)(E)(i)(II) of the
Act). Second, the number of cost
measures has increased over time, and
therefore, more MIPS eligible clinicians
are being measured on the cost
performance category and on new
measures.
Additionally, based on our
calculation of cost performance category
scores for the CY 2022 performance
period/2024 MIPS payment year, we
observed lower scores for the cost
performance category than for the
quality performance category, even
though they each generally constitute 30
percent of the final score. Recent
analyses of CY 2022 performance
period/2024 MIPS payment year data
have identified the unweighted mean
cost performance category score was 59
out of 100, while the unweighted mean
score for the quality performance
category was 74 out of 100. We also note
that the unweighted mean scores were
95 out of 100 for the improvement
activities performance category and 94
out of 100 for the Promoting
Interoperability performance category.
There are several factors that may
have contributed to a significantly lower
score in the cost performance category,
compared to the other categories. First,
measures in the cost performance
category are scored against a benchmark
determined based on average
performance of all MIPS eligible
clinicians during that same performance
period (§ 414.1380(b)(2) introductory
text and (b)(2)(i)) rather than a
benchmark determined based on
historical data, which is used, wherever
possible, for non-administrative claimsbased quality measures in the quality
performance category. Benchmarks
determined based on historical data for
the quality performance category
provide MIPS eligible clinicians with
helpful performance targets in advance
of or during the performance period.
Meanwhile, the performance period
benchmarks for the cost performance
category do not provide MIPS eligible
clinicians with information about
performance targets before or during the
performance period. We believe that
using benchmarks based in the
performance period is a better approach
for the cost performance category than
using benchmarks based on historical
data because different payment policies
776 https://qpp-cm-prodcontent.s3.amazonaws.com/uploads/2378/
2023%20MIPS%20Cost%20User%20Guide.pdf.
777 https://qpp-cm-prodcontent.s3.amazonaws.com/uploads/816/
2020%20Cost%20Quick%20Start%20Guide.pdf.
778 https://qpp-cm-prodcontent.s3.amazonaws.com/uploads/1298/
2021%20MIPS%20Cost%20Quick%20
Start%20Guide.pdf.
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Benchmark Decile
Benchmark Decile 1
Benchmark Decile 2
Benchmark Decile 3
Benchmark Decile 4
Benchmark Decile 5
Benchmark Decile 6
Benchmark Decile 7
Benchmark Decile 8
Benchmark Decile 9
Benchmark Decile 10
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may apply during the historical period
than during the performance period,
which may affect the cost of care for
patients treated by MIPS eligible
clinicians.
Second, in traditional MIPS
(compared to MVP reporting), MIPS
eligible clinicians are scored on each
cost measure for which they meet the
established case minimum and a
benchmark can be calculated. In the
quality performance category, if a
clinician reports more than the required
number of quality measures, we use the
highest scored outcome measure and
then the next highest scored measures to
reach a total of 6 sored quality measures
to calculate the clinician’s MIPS quality
performance category score. The current
cost benchmark methodology uses a
decile range based on linear percentile
distributions and assigns 5.0 to 6.9
achievement points to clinicians with
cost measure scores within the 50th to
60th percentiles (Table 68).
For the example cost measure
presented in Table 68, the cost measure
median, the 50th percentile, is $969.72.
If a MIPS eligible clinician’s average
cost per episode for the measure is
$1,104 (about $135 above the median),
the MIPS eligible clinician’s cost falls
within Benchmark Decile 2, for which
the MIPS eligible clinician may receive
between 2.0 and 2.9 achievement
points. We then use the following
formula to determine the number of
partial points awarded to the MIPS
eligible clinician:
Benchmark Decile # + [(measure score,
expressed as a dollar
amount¥bottom of benchmark
decile range)/(top of benchmark
decile range¥bottom of benchmark
decile range)] = Cost Measure
Achievement Points.779
Based on this partial points
calculation formula, the clinician would
receive 0.3 partial points, resulting in a
cost measure score of 2.3 out of 10
achievement points for the Screening/
Surveillance Colonoscopy cost measure
under this example.
This score may have the effect of
lowering the MIPS eligible clinician’s
final score, as discussed previously. If
the MIPS eligible clinician is only
attributed and scored on this single cost
measure and does not receive a cost
improvement score, then their score for
the cost performance category would be
based on the cost measure’s score of 2.3
out of 10 achievement points. Their
score for the cost performance category
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2023%20MIPS%20Cost%20User%20Guide.pdf.
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would be 0.23 (2.3/10 = 0.23), equal to
the total number of achievement points
earned by the MIPS eligible clinician
divided by the total number of available
achievement points under
§ 414.1380(b)(2)(iii)(A). Based on the
final score calculation under
§ 414.1380(c), the contribution of the
cost performance category score to the
final score for this MIPS eligible
clinician would be equal to the cost
performance category score multiplied
by the cost performance category weight
(30 percent if the MIPS eligible clinician
has not received any reweighting) and
would be 6.9 out of 30 (0.23 × 30 = 6.9),
which would be 23 out of 100 points for
the cost performance category’s
contribution to the final score.
To illustrate how this cost
performance category score could lower
the final score, if this MIPS eligible
clinician received perfect scores in each
of the other three performance
categories, based on the final score
calculation under § 414.1380(c) and the
respective performance category weights
when all four performance categories
are scored without reweighting, we
would use the formula as described
below. For this example, we have not
included the complex patient bonus.
MIPS Final score = [(60/60 × 30 for
quality) + (2.3/10 × 30 for cost) +
(40/40 × 15 for improvement
activities) + (100/100 × 25 for
Promoting Interoperability)] × 100 =
76.9.
In this example, MIPS final score of
76.9 for the MIPS eligible clinician is
just above the 2024 MIPS payment year
performance threshold of 75. Therefore,
under the current cost scoring
methodology, a MIPS eligible clinician
scoring near the median on a cost
measure would need to score perfectly
(or nearly perfectly) within the other
three performance categories to receive
a final score slightly above the
performance threshold and to avoid a
negative payment adjustment. The
unweighted cost performance category
score of 23 out of 100 noticeably lowers
the MIPS eligible clinician’s MIPS final
score.
(B) Proposed Modification to Scoring
Methodology for the Cost Performance
Category Beginning With CY 2024
Performance Period/2026 MIPS
Payment Year
In light of the concerns identified
with our current cost scoring policies,
we are proposing to modify the
methodology for scoring the cost
performance category beginning with
the CY 2024 performance period/2026
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MIPS payment year. The proposed cost
scoring methodology would be based on
standard deviation, median, and an
achievement point value that is derived
from the performance threshold.
Specifically, for a MIPS eligible
clinician whose average costs attributed
under a cost measure would be equal to
the median cost for all MIPS eligible
clinicians attributed that measure, we
would assign an achievement point
value equal to 10 percent of the
performance threshold. For example, for
the CY 2024 performance period/2026
MIPS payment year, the median would
have an achievement point value of 7.5,
based on a performance threshold of 75
as finalized at § 414.1405(b)(9)(iii). For
each cost measure, the cut-offs for
benchmark ranges would be calculated
based on standard deviations, expressed
in dollars, from the median.
The benchmark ranges, the median,
and the performance threshold-derived
achievement point values aligned with
the median would be dynamic and
responsive to changes in average costs
per episode or per beneficiary assessed
by cost measures and performance
thresholds for each CY performance
period/MIPS payment year. The
performance threshold-derived point
values could change based on the
performance threshold established for
each performance period/MIPS payment
year. The standard deviations from the
median used to determine cutoffs for
benchmark ranges for each year would
be reviewed for any necessary updates
annually based on performance across
MIPS eligible clinicians within the cost
performance category and the
performance threshold established for
the performance period/MIPS payment
year. We would perform analyses when
the performance threshold changes to
set the benchmark ranges. To determine
the benchmark ranges, we would adhere
to the following principles: (1) center
the majority of average costs per episode
or per beneficiary around the
performance threshold-derived point
value; (2) determine benchmark ranges
according to the statistical distribution
curve of the average cost per episode or
per beneficiary; and (3) distribution of
achievement points for cost measures
should be reflective of overall program
performance. We refer readers to Table
69 for an example of how the proposed
cost scoring methodology could be
implemented for a specific cost measure
when the performance threshold is set
to 75.
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TABLE 69: Example of Implementation of the Proposed Cost Scoring Methodology for
Assignment of Achievement Points for Performance on the Screening/Surveillance
Colonoscopy cost measure
Median
Median
Median
Median
Median
Median cost Median cost - 1 x standard deviation
Median cost -
Continuing with the example of the
Screening/Surveillance Colonoscopy
cost measure, now presented in Table
69 as an example of implementation of
the proposed cost scoring methodology,
the median (50th percentile) cost would
remain $969.72. Under the proposed
cost scoring methodology, for the CY
2024 performance period/2026 MIPS
payment year, a MIPS eligible clinician
with a cost per episode equal to the
median cost of all cases attributed to all
MIPS eligible clinicians would receive
7.5 achievement points out of 10
possible achievement points.
Using the same example as previously
presented in section IV.A.4.f.(1)(d)(ii)(A)
of this proposed rule, we would apply
the proposed cost scoring benchmark
methodology as shown in Table 69 to a
MIPS eligible clinician with an average
cost per episode for this measure that is
$1,104 (about $135 above the median).
Based on the analysis of data in this
example, the standard deviation for the
Screening/Surveillance Colonoscopy
cost measure would be $135.35. This
value for the standard deviation would
then be used to calculate the benchmark
ranges in Table 69 by plugging in this
value for the standard deviation for each
benchmark range. For example,
‘‘Median cost + (1 × $135.35)’’ would be
calculated for ‘‘Median cost + (1
standard deviation)’’ for the bottom of
Benchmark range 6. As shown with the
example in Table 69, under our
proposed cost scoring methodology, the
MIPS eligible clinician’s average cost
per episode of $1,104 would fall within
Benchmark Range 6 for the Screening/
Surveillance Colonoscopy cost measure,
for which the MIPS eligible clinician
may receive between 6.0 and 6.9
achievement points.
Under our proposal to modify the cost
performance category’s scoring
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$1341.93 -$1308.10
$1308.09 - $1.274.26
$1274.25 - $1240.43
$1240.42- $1172.75
$1172.74 - $1105.08
$1105.07 - $1037.40
$ I 037.39 - $902.05
$902.04 - $834.38
$834.37 - $766.70
$766.69 and below
cost +
cost+
cost + 2 x standard deviation
cost+ 1.5 x standard deviation
cost + 1 standard deviation
methodology for individual cost
measures, we would continue to use our
established formula to assign partial
achievement points:
Benchmark Range # + [(measure score,
expressed as a dollar
amount¥bottom of benchmark
range)/(top of benchmark
range¥bottom of benchmark
range)] = Cost Measure
Achievement Points.
As a result, using the example shown
in Table 69, under our proposed cost
scoring methodology, the MIPS
clinician would receive 6.02 cost
measure achievement points (6 +
[($1,104¥$1,105.07)/
($1,037.40¥$1,105.07)] = 6.02). The
assignment of 6.02 achievement points
under the proposed cost scoring
methodology would be closer to the
performance threshold equivalent of 7.5
than the assignment of 2.3 achievement
points under the current cost scoring
methodology, as discussed in our
previous example in section
IV.A.4.f.(1)(d)(ii)(A) of this proposed
rule.
In this example, the MIPS eligible
clinician’s score for the cost
performance category would be 0.602
(6.02/10 = 0.602), equal to the total
number of achievement points earned
by the MIPS eligible clinician divided
by the total number of available
achievement points under
§ 414.1380(b)(2)(iii)(A). Based on the
final score calculation under
§ 414.1380(c), the contribution of the
cost performance category score to the
final score for this MIPS eligible
clinician would be equal to the cost
performance category score multiplied
by the cost performance category weight
(30 percent if the MIPS eligible clinician
has not received any reweighting) and
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would be 18.06 out of 30 (0.602 × 30 =
18.06) or 60.2 out of 100.
If this MIPS eligible clinician received
perfect scores in each of the other three
performance categories, based on the
final score calculation under
§ 414.1380(c) and the respective
performance category weights when all
four performance categories are scored
without reweighting, we would use the
formula as described below. For this
example, we have not included the
complex patient bonus.
MIPS Final score = [(60/60 × 30 for
quality) + (6.02/10 × 30 for cost) +
(40/40 × 15 for improvement
activities) + (100/100 × 25 for
Promoting Interoperability)] × 100 =
88.06.
This MIPS final score of 88.06 for the
MIPS eligible clinician would be well
above the 2024 MIPS payment year
performance threshold of 75. The cost
performance category score of 60.2 out
of 100 would not noticeably lower the
MIPS eligible clinician’s MIPS final
score.
This proposed modification in our
scoring methodology for cost measures
would align the assignment of
achievement points for cost measures so
that clinicians with costs near the
measure’s 50th percentile (median)
would not receive a disproportionately
low score. Based on our analyses
utilizing data from the CY 2022
performance period/2024 MIPS
payment year, this proposed
methodology would increase the mean
cost performance category score
(unweighted) for clinicians with a cost
performance category score from 59 out
of 100 to 71 out of 100 (an increase of
11.9 points). Further, this proposed cost
scoring methodology would increase the
means for each cost measure score by
amounts ranging from 0.04 to 2.52
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points. Our analysis showed that, under
our proposed methodology, the mean
final score for MIPS eligible clinicians
assessed on at least one cost measure
and receiving a cost performance
category score would increase by 3.89
points. Under our analysis, our
proposed scoring methodology would
not negatively impact MIPS eligible
clinicians whose average costs for a
specific cost measure are around the
median.
Specifically, our analysis supports our
intended goal for the proposed
modification to the scoring
methodology: MIPS eligible clinicians
who deliver care at an average cost near
the median costs for all MIPS eligible
clinicians attributed the measure would
receive scores at, or very close to, the
performance threshold-derived score.
Additionally, this proposed
modification would address MIPS
eligible clinicians’ concerns that cost
measure scoring negatively impacts
their final scores more than other
performance categories, including
disparate negative effects for MIPS
eligible clinicians who are scored on the
cost performance category compared to
clinicians not scored on the cost
performance category.
To codify this proposed policy, we
propose to modify § 414.1380(b)(2) to
specify that achievement points are
awarded based on which benchmark
range the MIPS eligible clinician’s
performance on the measure is in. We
also propose to specify that CMS assigns
partial points based on where the MIPS
eligible clinician’s performance falls
between the top and the bottom of the
benchmark ranges. The terms ‘‘decile’’
and ‘‘percentile distribution’’ are
currently used in § 414.1380(b)(2) to
describe the scoring methodology used
to award achievement points and assign
partial points. However, under the
proposed methodology, the term
‘‘decile’’ no longer accurately describes
how the benchmark ranges would be
constructed. We believe the more
general term ‘‘benchmark range’’
accurately describes both the current
and the proposed cost scoring
methodology, and therefore propose to
modify § 414.1380(b)(2) to use
‘‘benchmark range’’ in lieu of ‘‘decile’’
and ‘‘percentile distribution.’’ We are
not proposing any modifications to the
remainder of the language currently at
§ 414.1380(b)(2), which provides that,
for each cost measure attributed to a
MIPS eligible clinician, the clinician
receives one to ten achievement points
based on the clinician’s performance on
the measure during the performance
period compared to the measure’s
benchmark.
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We are also not proposing any
modifications to the language currently
at § 414.1380(b)(2)(i), generally
governing if and how CMS determines
a cost measure’s benchmark. However,
we are proposing to codify our current
cost scoring policy, previously finalized
in the CY 2017 QPP final rule (81 FR
77308 through 77311), with
modification by adding language at
§ 414.1380(b)(2)(i)(A). We propose to
specify at § 414.1380(b)(2)(i)(A) that, for
the 2019 through 2025 MIPS payment
years, CMS determines cost measure
benchmark ranges based on linear
percentile distributions.
We are also proposing to codify our
proposed benchmarking methodology at
§ 414.1380(b)(2)(i)(B). We propose to
specify at § 414.1380(b)(2)(i)(B) that,
beginning with the 2026 MIPS payment
year, for each cost measure, CMS
determines 10 benchmark ranges based
on the median cost of all MIPS eligible
clinicians attributed the measure, plus
or minus standard deviations and that
CMS awards achievement points based
on which benchmark range a MIPS
eligible clinician’s average cost for a
cost measure corresponds. We also
propose to codify at
§ 414.1380(b)(2)(i)(B) that, beginning
with the 2026 MIPS payment year, CMS
awards achievement points equivalent
to 10 percent of the performance
threshold for a MIPS eligible clinician
whose average cost attributed under a
cost measure is equal to the median cost
for all MIPS eligible clinicians
attributed the measure.
We request public comments on this
proposal to modify our scoring
methodology for measures specified
under the cost performance category.
(iii) Proposed Adoption of Additional
Cost Measure Exclusion Policy
(A) Background on Cost Measure
Exclusion Policy
We refer readers to
§ 414.1380(b)(2)(v)(A) and the CY 2022
PFS final rule (86 FR 65507 through
65509) for our previously established
policy for excluding a single cost
measure from a MIPS eligible clinician’s
score for the cost performance category.
As described at § 414.1380(b)(2)(v)(A),
we established that, beginning with the
2024 MIPS payment year, if data used
to calculate a score for a cost measure
are impacted by significant changes
during the performance period, such
that calculating the cost measure score
would lead to misleading or inaccurate
results, then the affected cost measure is
excluded from the MIPS eligible
clinician’s or group’s cost performance
category score. We also established at
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§ 414.1380(b)(2)(v)(A) that ‘‘significant
changes’’ are changes external to the
care provided, and that CMS determines
may lead to misleading or inaccurate
results. We specified at
§ 414.1380(b)(2)(v)(A) that significant
changes include, but are not limited to,
rapid or unprecedented changes to
service utilization, and will be
empirically assessed by CMS to
determine the extent to which the
changes impact the calculation of a cost
measure score that reflects clinician
performance.
As described in the CY 2022 PFS final
rule (86 FR 65507 through 65509), we
finalized the policy at
§ 414.1380(b)(2)(v)(A) to provide scoring
flexibility in instances where changes
during a performance period impede the
effective measurement of cost. We
identified that there is a need for
additional flexibility in calculating the
scores for cost measures to account for
the impact of changing conditions that
are beyond the control of individual
MIPS eligible clinicians and groups. We
noted that this flexibility would allow
us to ensure that clinicians are not
impacted negatively when performance
is affected not due to the care provided,
but due to external factors. We noted
that we would determine whether such
external changes impede the effective
measurement of cost by considering
factors including: The extent and
duration of the changes, and the
conceptual and empirically tested
relationship between the changes and
each measure’s ability to accurately
capture clinician cost performance (86
FR 65508). Empirical testing could
include assessing whether there are
rapid or unprecedented changes to
patient case volume or case mix, and the
extent to which this could lead to
misleading or inaccurate results (86 FR
65508).
(B) Proposal To Permit Exclusion of a
Cost Measure When Impacted by Errors
and When Significant Changes Occur
Outside of the Performance Period
In the CY 2022 PFS final rule, for the
quality performance category, we
modified the quality measure exclusion
policy at § 414.1380(b)(1)(vii)(A) to
change ‘‘significant changes’’ to
‘‘significant changes or errors’’ (86 FR
65492) and to include the omission of
codes or inclusion of inactive or
inaccurate codes to provide that for each
measure submitted, if applicable, and
impacted by significant changes or
errors prior to the applicable data
submission deadline at § 414.1325(e),
performance is based on data for 9
consecutive months of the applicable
CY performance period. Currently, for
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the cost performance category, we do
not include ‘‘errors’’ in addition to
‘‘significant changes’’ within our cost
measure exclusion policy at
§ 414.1380(b)(2)(v)(A). To provide CMS
with greater flexibilities to be
responsive to any errors or significant
changes outside of the control of MIPS
eligible clinicians that negatively impact
the ability of specific cost measure(s) to
assess clinician performance, we are
proposing to add a new cost measure
exclusion policy at
§ 414.1380(b)(2)(v)(B) similar to the
quality measure exclusion policy.
Additionally, to further align our
measure exclusion policies among the
performance categories, we propose to
include ‘‘errors’’ for the cost
performance category. Specifically, we
are proposing that, beginning with the
2027 MIPS payment year, if data used
to calculate a score for a cost measure
are impacted by significant changes or
errors affecting the performance period,
such that calculating the cost measure
score would lead to misleading or
inaccurate results, then the affected cost
measure is excluded from the MIPS
eligible clinician’s or group’s cost
performance category score.
For purposes of this cost measure
exclusion policy at
§ 414.1380(b)(2)(v)(B), we are proposing
to define ‘‘significant changes or errors’’
as changes or errors external to the care
provided, and that CMS determines may
lead to misleading or inaccurate results
that negatively impact the measure’s
ability to reliably assess performance.
While we are proposing to include
‘‘errors’’ within this policy for the cost
performance category, as the quality
performance category already does, the
list of what ‘‘significant changes or
errors’’ includes would differ by
performance category to capture
differences in how cost measures and
quality measures are calculated and
measured. For instance, unlike quality
measures for which MIPS eligible
clinicians generally must submit data to
CMS to be assessed, cost measures are
calculated by CMS solely based on the
review of administrative claims data
and should not be impacted by
reporting errors. However, cost
measures could be impacted by CMS
calculation errors. Further, under our
proposed cost measure exclusion policy,
errors would be external to the care
provided, and such that CMS
determines may lead to misleading or
inaccurate results that negatively impact
the measure’s ability to reliably assess
performance. Under our proposed
exclusion policy for cost measures,
significant changes or errors would
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include, but would not be limited to,
rapid or unprecedented changes to
service utilization, the inadvertent
omission of codes or inclusion of codes,
or changes to clinical guidelines or
measure specifications. Additionally,
these would not automatically result in
cost measure exclusion. Instead, we
would determine whether there is a
negative impact from the significant
change or error when deciding if a cost
measure will be excluded.
Specifically, before applying this cost
measure exclusion policy, we are
proposing that CMS would empirically
assess the affected cost measure to
determine the extent to which the
changes or errors impact the calculation
of a cost measure score such that
calculating the cost measure score
would lead to misleading or inaccurate
results that negatively impact the
measure’s ability to reliably assess
performance. We believe that it is
important to clarify that a change or
error would not automatically result in
measure exclusion, but instead, that we
would need to determine whether there
is a negative impact from the change or
error that would affect cost measure
scoring.
Because significant changes or errors
can have an ongoing impact on a
measure beyond a single performance
period, we are proposing that the new
cost measure exclusion policy at
§ 414.1380(b)(2)(v)(B) allow us to
exclude cost measures when such
changes and errors occur outside of the
performance period, but otherwise affect
the performance period. For example, if
a cost measure is impacted by a coding
change or guidance that requires
substantive changes to a measure, we
may not be able to modify the measure
within one performance period. In such
circumstances, we would want to
exclude the cost measure for the
affected performance periods due to the
ongoing impact on the measure. We
would ensure that if data used to
calculate a score for a cost measure are
impacted by significant changes or
errors affecting one or more
performance periods delivering
misleading or inaccurate results, then
the affected cost measure could be
excluded from the MIPS eligible
clinician’s or group’s cost performance
category score. We believe that the cost
measure should be able to be excluded
regardless of when we become aware of
the issue, when the significant change
came into effect, or when the error first
occurred. Therefore, we are proposing
language at § 414.1380(b)(2)(v)(B) to
address data used to calculate a score
for a cost measure being impacted by
significant changes and errors affecting
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a performance period, even if they do
not occur during the performance
period.
We are proposing that this cost
measure exclusion policy would be
effective beginning with the CY 2025
performance period/2027 MIPS
payment year so this policy would be in
place as soon as feasible after the
opportunity for notice-and-comment
rulemaking.
This proposal would add language at
§ 414.1380(b)(2)(v)(B) to specify that,
beginning with the 2027 MIPS payment
year, if data used to calculate a score for
a cost measure are impacted by
significant changes or errors affecting
the performance period, such that
calculating the cost measure score
would lead to misleading or inaccurate
results, then the affected cost measure
would be excluded from the MIPS
eligible clinician’s or group’s cost
performance category score. We propose
to specify that ‘‘significant changes or
errors’’ are changes or errors external to
the care provided, and that CMS
determines may lead to misleading or
inaccurate results that negatively impact
the measure’s ability to reliable assess
performance. We also propose to specify
that significant changes or errors would
include, but are not limited to, rapid or
unprecedented changes to service
utilization, the inadvertent omission of
codes or inclusion of codes, or changes
to clinical guidelines or measure
specifications. We propose that CMS
would empirically assess the affected
cost measure to determine the extent to
which the changes or errors impact the
calculation of a cost measure score such
that calculating the cost measure score
would lead to misleading or inaccurate
results that negatively impact the
measure’s ability to reliably assess
performance.
We request public comments on this
proposal.
g. MIPS Payment Adjustments
(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
payments such that MIPS eligible
clinicians with final scores above the
performance threshold receive a
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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), CY 2023 PFS
final rule (87 FR 70096 through 70102),
and CY 2024 PFS final rule (88 FR
79373 through 79380).
(2) Establishing the Performance
Threshold
(a) Statutory Authority and Background
As discussed above, 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
application of the performance
threshold for our determination of MIPS
payment adjustment factors. These
special rules are no longer applicable for
establishing the performance threshold
for the CY 2025 performance period/
2027 MIPS payment year. We refer
readers to the CY 2024 PFS proposed
rule (88 FR 52596) for further
information on these previously
applicable requirements as they explain
our prior computations of the
performance threshold.
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 performance period/
2024 MIPS payment year through CY
2024 performance period/2026 MIPS
payment year. We also established in
our regulation at § 414.1405(g) that, for
each of the 2024, 2025, and 2026 MIPS
payment years, the performance
threshold would be the mean of the
final scores for all MIPS eligible
clinicians from a prior period. As
discussed under section IV.A.4.g.(2)(b)
of this proposed rule, we are proposing
to continue using the mean as the
methodology for determining the
performance threshold for the 2027,
2028, and 2029 MIPS payment years.
In the CY 2024 PFS final rule (88 FR
79373 through 79380), we established
the performance threshold for the CY
2024 performance period/2026 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.
As further discussed under section
IV.A.4.g.(2)(c), we are proposing to
continue using the mean of the final
scores for all MIPS eligible clinicians
from the CY 2017 performance period/
2019 MIPS payment year to establish
the performance threshold as 75 points
for the CY 2025 performance period/
2027 MIPS payment year.
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), CY 2023
PFS final rule (87 FR 70096 through
70100), and CY 2024 PFS final rule (88
FR 79373 through 79380).
We codified the performance
thresholds for each of the first 8 years
of MIPS at § 414.1405(b)(4) through (9).
These performance thresholds are
shown in Table 71.
TABLE 71: Performance Thresholds for the CY 2017 Performance Period/2019 MIPS
Payment Year through the CY 2024 Performance Period/ 2026 MIPS Payment Years
Year of
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MIPS
Performanc
e Threshold
Change
from prior
year
I
llCT
llCT
llCT
llCT
llCT
llCT
Period
Period
Period
Period
Period
Period
2023
MIPS
Perform a
nee
Period
Year 1
Year2
Year3
Year4
Year5
Year6
Year7
Year8
3 points
15 points
30 points
45 points
60 points
75 points
75 Points
75 Points
NIA
12 points
15 points
15 points
15 points
15 points
0 points
2017
MIPS
Performa
I
2018
MIPS
Performa
2019
MIPS
Performa
I
2020
MIPS
Perfonna
I
2021
MIPS
Perfonna
I
2022
MIPS
Performa
I
2024
MIPS
Perform a
nee
Period
0 points
(b) Establishing the Performance
Threshold Methodology for the 2027,
2028, and 2029 MIPS Payment Years
Section 1848(q)(6)(D)(i) of the Act
requires that we compute the
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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
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Secretary. That section also provides
that the Secretary may reassess the
selection of the mean or median every
three years. In accordance with section
1848(q)(6)(D)(i) of the Act, we are
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proposing to continue using the mean of
the final scores for all MIPS eligible
clinicians to compute the performance
threshold for the 2027, 2028, and 2029
MIPS payment years.
In the CY 2022 PFS final rule (86 FR
65527 through 65532), we selected the
mean (rather than the median) as the
methodology for determining the
performance threshold for the 2024,
2025, and 2026 MIPS payment years.
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
were no longer applicable for
establishing the performance threshold
for the CY 2024 performance period/
2026 MIPS payment year, these
previously applicable statutory
requirements explained prior
computations of the performance
threshold that impacted our policy
considerations for establishing the
performance threshold for MIPS going
forward. Based on our review of
possible values for the CY 2022
performance period/2024 MIPS
payment year, we believed that using
the mean as our methodology for setting
the performance threshold for the CY
2022 performance period/2024 MIPS
payment year through the CY 2024
performance period/2026 MIPS
payment year would continue the
‘‘gradual and incremental transition’’
that was previously required under
section 1848(q)(6)(D)(iv) of the Act, as
well as to provide consistency to our
stakeholders. Therefore, we finalized
the proposal to use the mean as our
methodology for setting the performance
threshold for that 3-year period. We also
codified this methodology in our
regulation at § 414.1405(g), providing
that, for each of the 2024, 2025, and
2026 MIPS payment years, the
performance threshold would be the
mean of the final scores for all MIPS
eligible clinicians from a prior period as
specified.
At the time of this proposed rule, we
have data available on MIPS eligible
clinicians’ final scores from the CY 2017
performance period/2019 MIPS
payment year through CY 2022
performance period/2024 MIPS
payment year, as shown in Table 72.
These values represent all available
computations of mean and median final
scores for those performance periods/
MIPS payment years. As discussed
previously, we may use either the mean
or median of the final scores from a
prior period for computing the
performance threshold for the next three
years, beginning with the CY 2025
performance period/2027 MIPS
payment year. At the time of this
proposed rule, we do not have available
MIPS eligible clinicians’ final scores
from performance periods after the CY
2022 performance period/2024 MIPS
payment year, which may inform the
performance thresholds for the CY 2026
performance period/2028 MIPS
payment year and CY 2027 performance
period/2029 MIPS payment year. As
provided in section 1848(q)(6)(D)(i) of
the Act, we must select whether we will
use the mean or median of MIPS eligible
clinicians’ final scores from a prior
period, which we may reassess after
three years. We assess these selection
options based on the data we currently
have available.
TABLE 72: Possible Values for the 2027 MIPS Payment Year Performance Threshold
2019MIPS
Payment
Year
74.65
89.71
2020MIPS
Payment
Year
87.00
99.63
As shown in Table 72, using the
median final score gives a possible
range of performance thresholds from
85.17 points to 99.63 points (rounded to
85 points and 100 points, respectively).
Given our performance threshold of 75
points for the CY 2024 performance
period/2026 MIPS payment year, these
values would result in an increase of 10
points to 25 points for the CY 2025
performance period/2027 MIPS
payment year, and potentially the CY
2026 performance period/2028 MIPS
payment year and CY 2027 performance
period/2029 MIPS payment year.
Selecting the median of final scores as
our methodology would, at a minimum,
result in a 13 percent increase in the
performance threshold of 75 points,
which we had established for the CY
2022 performance period/2024 MIPS
payment year through the CY 2024
performance period/2026 MIPS
payment year. Further, as shown in
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2021 MIPS
Payment
Year
85.65
92.32
2022MIPS
Payment
Year
89.47
96.82
Table 71, 75 points is the highest
performance threshold we have
established for any MIPS payment year
to date.
As shown in Table 72, using the mean
final score as the methodology would
yield a possible range of performance
thresholds from 74.65 points to 89.47
points (rounded to 75 points and 89
points, respectively). Given our
performance threshold of 75 points in
the CY 2024 performance period/2026
MIPS payment year, these values would
result in an increase of zero to 14 points
for the CY 2025 performance period/
2027 MIPS payment year, and
potentially the CY 2026 performance
period/2028 MIPS payment year and CY
2027 performance period/2029 MIPS
payment year. Selecting the mean of
final scores as our methodology would,
at a maximum, result in a 19 percent
increase in the performance threshold of
75 points, which we had established for
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2023MIPS
Payment
Year
89.22
97.22
2024MIPS
Payment
Year
82.71
85.17
the CY 2022 performance period/2024
MIPS payment year through the CY
2024 performance period/2026 MIPS
payment year.
We believe that it is appropriate to
incentivize performance improvement
while also ensuring that it is reflective
of true clinician performance. Moreover,
we believe that where possible, it is
important to offer stability and
consistency for clinicians. After
evaluating the possible values for mean
and median shown in Table 72 and our
prior policies for consistently selecting
a performance threshold value of 75
points for the CY 2022 performance
period/2024 MIPS payment year
through the CY 2024 performance
period/2026 MIPS payment year, we
believe that using the mean as our
methodology for the 2027 through 2029
MIPS payment years would offer the
most consistent and predictable
approach for MIPS eligible clinicians.
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On this basis, we are proposing to
continue using the mean of the final
scores for all MIPS eligible clinicians
from a prior period as specified to
compute the performance threshold for
each of the 2027 through 2029 MIPS
payment years.
We also are proposing to codify this
proposal by amending our regulation
text at § 414.1405. We propose to amend
§ 414.1405 by: (1) revising paragraph (g)
to read only ‘‘Performance Threshold
Methodology’’; (2) redesignating, with
minor technical modification, the
substantive provision at paragraph (g) as
a new paragraph (g)(1) to reflect the
performance threshold methodology we
established and used to specify the
performance threshold for the 2024,
2025 and 2026 MIPS payment years
under § 414.1405(b)(9); and (3) adding
paragraph (g)(2) to provide that, for each
of the 2027, 2028, and 2029 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
§ 414.1405(b)(10).
We request public comments on this
proposal.
(c) Establishing the Performance
Threshold for the CY 2025 Performance
Period/2027 MIPS Payment Year
We believe using the mean of 75
points from the CY 2017 performance
period/2019 MIPS payment year
continues to be the most appropriate
option for establishing the performance
threshold for the CY 2025 performance
period/2027 MIPS payment year for
various reasons described in this
section, including: providing
consistency for MIPS eligible clinicians
while allowing additional time for more
recent data to become available,
continuing to provide opportunities for
MIPS eligible clinicians to gain
experience with cost measure scoring
(particularly if the methodology
proposed in section IV.A.4.f.(1)(d)(ii)(B)
of this proposed rule is finalized), and
ensuring that we do not inadvertently
disadvantage certain clinician types,
such as small practices and solo
practitioners, as we increase the
performance threshold.
As shown in Table 72, we calculated
the mean values for the CY 2017
performance period/2019 MIPS
payment year through the CY 2022
performance period/2024 MIPS
payment year, and we believe that the
mean of 75 points from the CY 2017
performance period/CY 2019 MIPS
payment year continues to be the most
appropriate option that would provide
stability for MIPS eligible clinicians
while still encouraging high quality of
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care. The final scores for the CY 2023
performance period/2025 MIPS
payment year were not finalized in time
for this proposed rule and, therefore, the
mean final score for the CY 2023
performance period/2025 MIPS
payment year was not included for
consideration as a potential
performance threshold value for the CY
2025 performance period/2027 MIPS
payment year.
Though we did consider the mean of
87 points from the CY 2018 performance
period/2020 MIPS payment year, we
believe a substantial increase of 12
points could unfairly impact clinicians
as they continue to recover from the
COVID–19 public health emergency
(PHE), which ended on May 11, 2023.
We also considered using the means of
the final scores from the CY 2019
performance period/2021 MIPS
payment year through the CY 2022
performance period/2024 MIPS
payment year for establishing the CY
2025 performance period/2027 MIPS
payment year performance threshold.
However, we decided they would not be
appropriate for measuring future
clinician performance given the impact
of the COVID–19 PHE on data for MIPS,
as described below.
Given issues with underlying data in
prior periods due to the COVID–19
pandemic, we believe that we should
wait for more recent data that better
reflects clinicians’ performance and
continue to rely on data from the CY
2017 performance period/2019 MIPS
payment year, which predated the
COVID–19 PHE. Due to the timing of the
COVID–19 PHE and our announcement
on March 22, 2020, extending the
deadline for MIPS data submission,780
we are still evaluating the usability of
data from the CY 2019 performance
period/2021 MIPS payment year. While
data collection occurred during the CY
2019 performance period prior to the
start of the COVID–19 PHE, data
submission for the CY 2019
performance period (occurring during
the first quarter of CY 2020) was
impacted. Specifically, in addition to
extending the deadline for submitting
MIPS data, we announced on April 6,
2020, that, due to the COVID–19 PHE,
we would apply our extreme and
uncontrollable circumstances
reweighting policies described under
§ 414.1380(c)(2)(i) to MIPS eligible
clinicians nationwide and extend the
deadline to submit an application for
reweighting the quality, cost,
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62091
improvement activities or Promoting
Interoperability reporting categories for
the CY 2019 performance period/2021
MIPS payment year (85 FR 19277 and
19278). These flexibilities for the
submission of MIPS data occurring in
the first quarter of CY 2020 were
intended to alleviate reporting burden
on clinicians that were responding to
the onset of the COVID–19 pandemic.
We believe the geographic differences of
COVID–19 incidence rates along with
different impacts resulting from Federal,
state, and local laws and policy changes
implemented in response to COVID–19
may have affected which MIPS eligible
clinicians were able to submit data for
the CY 2019 performance period. This
may have led to final scores that were
not wholly representative of
performance for all MIPS eligible
clinicians. Also, for the CY 2020
performance period/2022 MIPS
payment year and the CY 2021
performance period/2023 MIPS
payment year, we extensively applied
our reweighting policies, described
under § 414.1380(c)(2)(i), to MIPS
eligible clinicians nationwide due to the
COVID–19 PHE. We believe these
actions, particularly reweighting the
performance categories, skewed the
final scores from those years such that
they are not an appropriate indicator for
future performance of MIPS eligible
clinicians. Specifically, we are
concerned that the final scores during
the COVID–19 PHE reflect the
performance of only MIPS eligible
clinicians that may have been less
impacted by the pandemic, and do not
accurately represent MIPS eligible
clinician performance overall during
this period.
As discussed further in section
IV.A.4.f.(1)(d)(ii) of this proposed rule,
MIPS eligible clinicians have expressed
concern that the cost performance
category scoring has a negative impact
on their MIPS final score. The CY 2022
performance period/2024 MIPS
payment year was the first MIPS
payment year that the cost performance
category score generally constituted 30
percent of MIPS eligible clinicians’ final
scores (section 1848(q)(5)(E)(i)(II) of the
Act). We have observed lower category
scores for the cost performance category
as compared to the quality performance
category. In light of these concerns,
which are supported by our analysis of
cost performance category scores as
discussed in section IV.A.4.f.(1)(d)(ii) of
this proposed rule, we believe that
maintaining a performance threshold of
75 points for the CY 2025 performance
period/2027 MIPS payment year would
provide stability for MIPS eligible
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clinicians as they become acquainted
with the cost performance category
(particularly if the scoring methodology
proposed in section IV.A.4.f.(1)(d)(ii)(B)
of this proposed rule is finalized)
without unfairly and negatively
impacting their final scores and MIPS
payment adjustments. We also believe
maintaining the performance threshold
at 75 points for the 2027 MIPS payment
year would provide us time to
incorporate the impacts of this proposed
cost performance category scoring
methodology (if finalized) as we
establish future performance thresholds.
As discussed in section
IV.A.4.f.(1)(d)(ii) of this proposed rule,
we believe multiple factors have likely
contributed to MIPS eligible clinicians’
concerns, including increases in the
weight for the cost performance category
over time (see section 1848(q)(5)(E)(i)(II)
of the Act), the number of cost
measures, and the number of MIPS
eligible clinicians that are being
attributed new cost measures and
receiving a score for the cost
performance category. This increase in
weight for the cost performance category
over time has been particularly notable
because, as discussed previously, due to
the application of our reweighting
policies described under
§ 414.1380(c)(2)(i) for the COVID–19
PHE, many MIPS eligible clinicians
were not scored on the cost performance
category for the CY 2019 performance
period/2021 MIPS payment year
through the CY 2021 performance
period/2023 MIPS payment year (85 FR
19277 through 19278).781 782 We believe
that our proposal to maintain a
performance threshold of 75 points for
the CY 2025 performance period/2027
MIPS payment year may help alleviate
some of MIPS eligible clinicians’
concerns related to the cost performance
category and its impact on their MIPS
final score.
We are also concerned that any
increase in the performance threshold
may inadvertently and unfairly
disadvantage certain clinician types,
specifically small practices and solo
practitioners. As we stated in the CY
2024 PFS final rule, we want to consider
the impacts of the performance
threshold and its related policies on
small practices (88 FR 79377). We have
received feedback that many small
practices and solo practitioners face
781 https://qpp-cm-prodcontent.s3.amazonaws.com/uploads/1198/2020%
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20MIPS%20Automatic%20EUC%20
Fact%20Sheet.pdf.
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challenges in their ability to participate
in MIPS, including the costs to
implement and maintain certified
electronic health record (EHR)
technology (CEHRT), staff and training
costs, and limited staff capacity to
manage the complexity of the program.
We have also heard that increases in the
performance threshold add
administrative and financial burden for
small practices that discourage their
participation in MIPS. Though we have
several policies within MIPS that
continue to support small and solo
practices, including scoring and
reweighting policies, we are interested
in understanding how to best support
small practices and enhance their ability
to successfully participate in MIPS as
MIPS continues to evolve. As such, we
have performed qualitative analysis
through engagement with small
practices, third party intermediaries,
and other interested parties to gather
information about the experience of
small practices participating in the
program. We are also planning to reach
out to small practices and solo
practitioners in CY 2024 to gather
additional information about barriers for
actively engaging with MIPS. On this
basis, we believe establishing a
performance threshold of 75 points for
the CY 2025 performance period/2027
MIPS payment year would allow us
time to gather additional data on the
impacts of new policies on small and
rural practices, and to develop strategies
to reduce barriers for small practices
and solo practitioners participating in
MIPS.
We refer readers to the Regulatory
Impact Analysis in section VII.E.17.d.(4)
of this proposed rule for an estimate of
the percent of MIPS eligible clinicians
that would receive a negative payment
adjustment for the CY 2025 performance
period/2027 MIPS payment year if the
policies proposed in this proposed rule
are finalized and the performance
threshold is established at 75 points.
As discussed in this section
IV.A.4.g.(2)(c), we believe that
maintaining a performance threshold of
75 points allows additional time for
more data to become available,
continues to provide opportunities for
clinicians to become familiar with the
cost measure scoring, and ensures that
we do not inadvertently disadvantage
certain clinician types, such as small
practices and solo practitioners.
Therefore, we are proposing to establish
a performance threshold of 75 points for
the CY 2025 performance period/2027
MIPS payment year based on the mean
of MIPS eligible clinicians’ final scores
from the CY 2017 performance period/
2019 MIPS payment year, and to codify
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this performance threshold in our
regulation by adding paragraphs at
§ 414.1405(b)(10) introductory text and
(b)(10)(i).
We request public comments on this
proposal.
(3) Example of Adjustment Factors
Figure 4 provides an illustrative
example of how various final scores
would be converted to a MIPS payment
adjustment factor using the statutory
formula and based on our proposed
policies for the CY 2025 performance
period/2027 MIPS payment year. In
Figure 4, the performance threshold is
set at 75 points, as we have proposed in
section IV.A.4.g.(2)(c) of this 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 2025 performance
period/2027 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
18.75 points based on the proposed
performance threshold of 75 points for
the CY 2025 performance period/2027
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 75
points (the performance threshold
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proposed for the CY 2025 performance
period/2027 MIPS payment year) will
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 4 does
62093
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.
FIGURE 4: Illustrative Example of MIPS Payment Adjustment Factors Based on Final
Scores and Performance Threshold for the CY 2025 performance period/2027 MIPS
Payment Year
Calculated Payment
o
2
4
6
Final Score
a 10 12 :t4 1s 1s 20 22 24 26 :rn 10 32 3-4 so 38 40 42 44 415 4S so 52 :1,4 ss .58 60 62 64 66 6S 70
n
74 76
1s
a:o a2 84 Sfi as 90, 92 94 9,5 98 um
FINAL St'ORE
Note: The adjustment factor for final score values above the performance threshold is illustrative. For MIPS eligible
clinicians with a fmal score of 100, the adjustment factor will be 9 percent times a scaling factor greater than zero
and less than or equal to 3.0. The scaling factor is intended to ensure budget neutrality (BN) but cannot be higher
than 3.0. This example is illustrative as the actual payment adjustments may vary based on the distribution offmal
scores for MIPS eligible clinicians.
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2024 performance period/2026 MIPS
payment year and the proposed policies
for the CY 2025 performance period/
2027 MIPS payment year, as well as the
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applicable percent required by section
1848(q)(6)(B) of the Act.
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Table 73 illustrates the changes in
payment adjustment based on the final
policies from the CY 2024 PFS final rule
(88 FR 52599 through 56001) for the CY
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TABLE 73: Illustration of Point System and Associated Adjustments Comparison between
the CY 2024 Performance Period/2026 MIPS Payment Year and the CY 2025 Performance
Period/2027 MIPS Payment Year
MIPS Adjustment for 2024
Performance Period
Negative MIPS payment
adjustment greater than
negative 9% and less than 0%
on a linear sliding scale
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75.01-100
75.00
Positive MIPS payment
adjustment greater than 0% on
a linear sliding scale. The
linear sliding scale ranges from
greater than 0% to 9% for
scores from 75.01 to 100.00.
This sliding scale is multiplied
by a scaling factor greater than
zero but not exceeding 3.0 to
preserve budget neutrality.
h. Review and Correction of MIPS Final
Score—Feedback and Information To
Improve Performance
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; for the CY 2021
performance period/2023 MIPS
payment year on August 22, 2022; and
for the CY 2022 performance period/
2024 MIPS payment year on August 10,
2023. Although we aim to provide
feedback for the CY 2023 performance
period/2025 MIPS payment year on or
around July 1, 2024, it is possible the
release date could be later depending on
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Points
75.01-100
circumstances. We direct readers to
qpp.cms.gov for more information.
i. Calculating the Final Score
For a description of the statutory basis
and our previously finalized policies for
calculating the final score for each MIPS
eligible clinician, including
performance category weights and
reweighting the performance categories,
we refer readers to § 414.1380(c) and the
discussion in the CY 2017 and CY 2018
Quality Payment Program final rules,
and the CY 2019, CY 2020, CY 2021, CY
2022 and CY 2023 PFS final rules (81
FR 77319 through 77329, 82 FR 53769
through 53785, 83 FR 59868 through
59878, 84 FR 63020 through 63031, 85
FR 84908 through 84917, 86 FR 65509
through 65527, and 87 FR 70093
through 70096, respectively).
As described in more detail in the
following sections, we propose to
supplement our current policies for
reweighting one or more performance
categories (that is, quality, improvement
activities, and Promoting
Interoperability) to permit reweighting
in circumstances where we determine
that data for a MIPS eligible clinician
are inaccessible or unable to be
submitted due to circumstances outside
of the control of the clinician because
the MIPS eligible clinician delegated
submission of the data to their third
party intermediary, evidenced by a
written agreement between the MIPS
eligible clinician and third party
intermediary, and the third party
intermediary did not submit the data for
the performance category(ies) on behalf
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MIPS Adjustment for
2025 Performance
Period
Negative9%
Negative MIPS payment
adjustment greater than
negative 9% and less than
0% on a linear sliding
scale
0% adjustment
Positive MIPS payment
adjustment greater than
0% on a linear sliding
scale. The linear sliding
scale ranges from greater
than 0% to 9% for scores
from 75.01 to 100.00.
This sliding scale is
multiplied by a scaling
factor greater than zero
but not exceeding 3.0 to
preserve budget
neutralitv.
of the MIPS eligible clinician in
accordance with applicable deadlines.
We note that we are only proposing
that this reweighting policy be available
for the quality, improvement activities,
and Promoting Interoperability
performance categories because a MIPS
eligible clinician may delegate data
submission to a third party intermediary
only with respect to these three
performance categories, and not the cost
performance category. MIPS eligible
clinicians do not submit data separately
for measures for the cost performance
category; we score cost measures based
solely on Medicare claims data.
(1) Background
Section 1848(q)(5)(A) of the Act
requires the Secretary to develop a
methodology for assessing the total
performance of each MIPS eligible
clinician according to the performance
standards for the applicable measures
and activities for each performance
category applicable to such clinician for
a performance period and, using the
methodology, provide for a final score
(using a scoring scale of 0 to 100) for
each MIPS eligible clinician for the
performance period.
Additionally, section 1848(q)(5)(E) of
the Act specifies how we must weigh
the scores for each performance category
in our calculation of the MIPS eligible
clinician’s final score. We have codified
these weights at § 414.1380(c)(1).
Meanwhile, section 1848(q)(5)(F) of the
Act provides that, if there are not
sufficient measures and activities
applicable and available to each type of
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MIPS eligible clinician involved, the
Secretary shall assign different scoring
weights (including a weight of 0). We
previously finalized at § 414.1380(c)
that if a MIPS eligible clinician is scored
on fewer than two performance
categories, they will receive a final score
equal to the performance threshold (81
FR 77326 through 77328 and 82 FR
53778 through 53779).
We also have finalized at
§ 414.1380(c)(2) several policies
addressing on what basis we may
reweight one or more performance
categories, and how those weights will
be redistributed to the remaining
performance categories. For example, in
the CY 2020 PFS final rule (84 FR 63023
through 63026), we finalized a
reweighting policy at
§ 414.1380(c)(2)(i)(A)(9) and
(c)(2)(i)(C)(10) for the four MIPS
performance categories. Under this
policy, we may reweight one or more of
the performance categories for a MIPS
eligible clinician if we determine, based
on information known to us prior to the
beginning of the relevant MIPS payment
year, that data for a MIPS eligible
clinician for the applicable performance
category(ies) are inaccurate, unusable,
or otherwise compromised due to
circumstances outside of the control of
the clinician and its agents. Under this
policy, we are able to address
circumstances where submitted data are
inaccurate, unusable, or otherwise
compromised.
However, we have found this policy,
and our other reweighting policies at
§ 414.1380(c)(2), do not address
circumstances where data are
inaccessible or unable to be submitted
due to circumstances outside of the
control of the MIPS eligible clinician,
particularly where the clinician has
delegated submission of the data to a
third party intermediary and that third
party intermediary does not submit the
data in accordance with applicable
deadlines. In accordance with our
regulations governing third party
intermediaries at § 414.1400(a)(3)(iv)
and (e)(1), we may take remedial action
in the event a third party intermediary
fails to meet the criteria necessary for
their approval as a third party
intermediary, fails to comply with other
requirements applicable to third party
intermediaries, has submitted a false
certification, or discontinues their
services and do not assist MIPS eligible
clinicians in connecting with a different
third party intermediary. However, our
regulations do not address the impact of
a third party intermediary’s action or
inaction resulting in failure to submit
the MIPS eligible clinician’s data as
required, over which the MIPS eligible
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clinician has little to no control, on a
MIPS eligible clinician’s final score.
Currently, if we determine that data
for a MIPS eligible clinician were not
submitted during the MIPS data
submission period for reasons outside
the clinician’s control, we assign the
clinician a score of zero for the
performance category or categories for
which data were not submitted.783
Because an excusable failure to submit
data is not currently a basis for
reweighting, the lack of data may reduce
the MIPS eligible clinician’s final score
and therefore may reduce the clinician’s
MIPS payment adjustment. However,
we believe that reweighting of the
applicable performance categories may
be appropriate in these rare cases as
described in this section IV.A.4.i. of this
proposed rule.
Specifically, we believe that a MIPS
eligible clinician should not be
penalized in cases where the MIPS
eligible clinician enters into an
agreement with a third party
intermediary to submit data on their
behalf, and the data are not submitted
due to reasons outside of the control of
the MIPS eligible clinician. While we
encourage the impacted MIPS eligible
clinician to take steps to ensure data
submission for subsequent years, by, for
example, selecting an alternate third
party intermediary, there may be cases
where there is insufficient time for the
MIPS eligible clinician to submit the
data through an alternative mechanism
in time for the data to be considered for
the relevant performance period. For
instance, the MIPS eligible clinician
may become aware that their third party
intermediary did not submit data on
their behalf after the data submission
period closes. In these cases, we believe
it is appropriate to provide relief to the
MIPS eligible clinician so that they are
not unfairly penalized for their third
party intermediary’s inaction.
(2) Proposal To Adopt Reweighting
Performance Category(ies) Policy When
a Third Party Intermediary Did Not
Submit Data Due to Reasons Outside the
MIPS Eligible Clinician’s Control
We are proposing to adopt a new
reweighting policy at
§ 414.1380(c)(2)(i)(A)(10) and
(c)(2)(i)(C)(12) to address this
783 As set forth in § 414.1325(a), data is only
required to be submitted for certain measures and
activities as specified for certain performance
categories. For example, MIPS eligible clinicians are
not required to submit data for the cost performance
category to receive a score for that category because
cost measures are scored based on Medicare claims
data. We refer readers to our data submission
requirements at § 414.1325 and our proposal to
modify these requirements in section IV.A.4.d. of
this proposed rule.
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circumstance. Specifically, beginning
with the CY 2024 performance period/
2026 MIPS payment year, we are
proposing that we may reweight one or
more of the quality, improvement
activities, and Promoting
Interoperability performance categories
where we determine, based on
documentation submitted to us through
a reweighting request on or before
November 1st of the year preceding the
relevant MIPS payment year, that data
for a MIPS eligible clinician are
inaccessible or unable to be submitted
due to circumstances outside of the
control of the clinician because the
MIPS eligible clinician delegated
submission of their data to a third party
intermediary, evidenced by a written
agreement between the MIPS eligible
clinician and the third party
intermediary, and the third party
intermediary did not submit the data for
the performance category(ies) on behalf
of the MIPS eligible clinician in
accordance with applicable deadlines.
We also are proposing that, to determine
whether to apply reweighting to the
affected performance category(ies), we
will consider: whether the MIPS eligible
clinician knew or had reason to know of
the issue with its third party
intermediary’s submission of the
clinician’s data for the performance
category(ies); whether the MIPS eligible
clinician took reasonable efforts to
correct the issue; and whether the issue
between the MIPS eligible clinician and
their third party intermediary caused no
data to be submitted for the performance
category(ies) in accordance with
applicable deadlines. We believe these
factors are necessary to ensure we are
only granting these requests in
circumstances where MIPS eligible
clinicians would otherwise be unfairly
penalized due to the actions or inactions
of a third party intermediary. MIPS
eligible clinicians could request
reweighting under this proposed policy
in circumstances where no data was
submitted on their behalf by their third
party intermediary through the help
desk at QPP@cms.hhs.gov.
Under this proposed policy, MIPS
eligible clinicians would be able to
request reweighting for each
performance category for which their
third party intermediary, to which the
MIPS eligible clinician delegated
submission of their data, did not submit
data for reasons outside of the control of
the MIPS eligible clinician. We note that
we are only proposing that this
reweighting policy be available for the
quality, improvement activities, and
Promoting Interoperability performance
categories because a MIPS eligible
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clinician may delegate data submission
to a third party intermediary only with
respect to these three performance
categories, and not the cost performance
category. MIPS eligible clinicians do not
submit data separately for measures for
the cost performance category; we score
cost measures based solely on Medicare
claims data.
Under this proposed reweighting
policy, the MIPS eligible clinician must
submit reweighting requests beginning
with the close of a relevant performance
period’s data submission period, only
after it is confirmed that no data has
been submitted in accordance with
applicable deadlines. MIPS eligible
clinicians would be able to submit
reweighting requests on or before
November 1st of the year preceding the
associated MIPS payment year in order
to allow time for CMS to re-calculate
their final score and MIPS payment
adjustment factor.
We would only approve reweighting
requests with evidence of a written
agreement between the MIPS eligible
clinician and a third party intermediary.
Such written agreement must provide
that the MIPS eligible clinician
delegated submission of their data to the
third party intermediary, and that the
third party intermediary agreed to
submit data on their behalf in
accordance with applicable deadlines,
for the performance category or
performance categories in question.
We would review requests and make
determinations to reweight based on our
assessment that data were not submitted
outside the control of the MIPS eligible
clinician. As discussed in this section of
this proposed rule, we are proposing
that we would determine whether to
apply reweighting to the affected
performance category(ies) under this
policy based on our consideration of the
following criteria: whether the MIPS
eligible clinician knew or had reason to
know of the issue with its third party
intermediary’s submission of the
clinician’s data for the performance
category(ies); whether the MIPS eligible
clinician took reasonable efforts to
correct the issue; and whether the issue
between the MIPS eligible clinician and
their third party intermediary caused no
data to be submitted for the performance
category(ies) in accordance with
applicable deadlines. These criteria
would inform whether we would grant
reweighting requests under our
proposed policy at
§ 414.1380(c)(2)(i)(A)(10) and
(c)(2)(i)(C)(12). Circumstances resulting
in a clinician’s data being inaccessible
or unable to be submitted that would
merit reweighting could include, but are
not limited to, a critical systems failure,
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the third party intermediary going out of
business, the third party intermediary
having collected data on a MIPS eligible
clinicians behalf and refusing to hand it
over for the MIPS eligible clinician to
submit, or other circumstances CMS
determines to be outside the control of
the MIPS eligible clinician.
This proposed reweighting policy is
solely intended to mitigate the
potentially adverse financial impact of
no data being submitted during the
MIPS data submission period for one or
more performance categories on behalf
of the MIPS eligible clinician due to the
failure of a third party intermediary to
fulfill its contractual responsibilities.
Our determination to grant a
reweighting request under this proposed
policy does not indicate, and should not
be interpreted to suggest, that the third
party intermediary could not be held
liable for the failure to perform the task
as delegated, that is, to submit data on
the performance category(ies) on behalf
of the MIPS eligible clinician. In these
circumstances where we determine that
a third party intermediary failed to
fulfill its agreement with the MIPS
eligible clinician to submit their data,
we believe it is appropriate to give the
MIPS eligible clinician the opportunity
to request reweighting of the affected
performance category(ies), provided that
all elements of our proposed policy are
met.
We propose to apply reweighting only
in cases when we receive
documentation of a third party
intermediary failing to submit data on
behalf of a MIPS eligible clinician
demonstrating that all elements of our
proposed policy are met.
We propose that this policy would be
effective beginning with CY 2024
performance period/2026 MIPS
payment year. If finalized, this policy
change would become effective
prospectively, prior to the beginning of
the data submission period for the CY
2024 performance period/2026 MIPS
payment year, which will occur January
2, 2025, through March 31, 2025. We are
proposing this effective date to provide
relief to MIPS eligible clinicians, whose
circumstances meet all requirements set
forth in this proposed reweighting
policy, as soon as feasible.
We propose to codify this new
reweighting policy, including all
proposed elements as described in
section IV.A.4.i.(2) of this proposed
rule, at § 414.1380(c)(2)(i)(A)(10) for the
quality and improvement activities
performance categories and at
§ 414.1380(c)(2)(i)(C)(12) for the
Promoting Interoperability performance
category.
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We request public comments on this
proposal.
j. Third Party Intermediaries General
Requirements
(1) Requirements for CMS-Approved
Survey Vendors
(a) Background
As codified at § 414.1305, a CMSapproved survey vendor means a survey
vendor that is approved by CMS for a
particular performance period to
administer the Consumer Assessment of
Healthcare Providers & Systems
(CAHPS) for MIPS survey and to
transmit survey measures data to CMS.
We refer readers to § 414.1400(d), the
CY 2017 Quality Payment Program final
rule (81 FR 77386), the CY 2018 Quality
Payment Program final rule (82 FR
53818 and 53819), the CY 2019 PFS
final rule (83 FR 59907 and 59908), and
the CY 2022 PFS final rule (86 FR 65538
and 65539) for previously finalized
standards and criteria for CMSapproved survey vendors.
(b) Requirement To Submit Cost of
Services
In the CY 2017 Quality Payment
Program final rule (81 FR 77386 and
77387), we established that CMSapproved survey vendors may transmit
data collected from the CAHPS for MIPS
survey to CMS for use in MIPS. Section
414.1400(d)(2) requires that CMSapproved survey vendors submit a
survey vendor application to CMS in a
form and manner specified by CMS for
each MIPS performance period for
which it wishes to transmit such data.
We implemented this requirement
through the Vendor Participation Form,
which is available at https://
qpp.cms.gov/resources/resource-library.
The CY 2017 Quality Payment
Program final rule contained
requirements applicable to other types
of third party intermediaries, which
varied based on whether the third party
intermediary was a Qualified Clinical
Data Registry (QCDR) or qualified
registry. For example, we established
requirements for QCDRs and qualified
registries to ‘‘sign a document verifying
the QCDR’s name, contact information,
cost for MIPS eligible clinicians or
groups to use the QCDR or qualified
registry’’ (81 FR 77368 and 77369; 81 FR
77385 and 77386). If QCDRs and
qualified registries do not provide this
information, CMS may exclude them
from MIPS in a subsequent year. This
requirement helps eligible clinicians
determine which vendors to use prior to
registration and provides transparency
on the cost of program participation.
Currently, CMS-approved survey
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vendors are not required to provide cost
information even though other third
party intermediaries (QCDRs and
qualified registries) are required to do
so.
We are proposing under the current
application submission requirement at
§ 414.1400(d)(2) that beginning with the
CY 2026 performance period/2028 MIPS
payment year, a survey vendor must
include on its application the range of
costs of its third party intermediary
services. Ranges of cost estimates would
vary based on different levels of service
(i.e., number of survey respondents,
languages provided, etc.). With respect
to a third party intermediary that is
solely a CMS-approved survey vendor,
the publishable costs would be limited
to the cost of services related to the
CAHPS for MIPS survey. CMS has
received inquiries from MIPS
participants regarding survey vendor
costs but has not been able to provide
any specific information in response to
those requests. The cost information
from survey vendors is not easily
available to the MIPS eligible clinicians
who are considering contracting for
services. Having such information in the
publicly-accessible QPP Resource
Library (as part of the list of approved
vendors) would make it easier for MIPS
eligible clinicians to contract for
services and educate themselves about
the cost of using a third party
intermediary survey vendor. In recent
years, some participants who registered
for the CAHPS for MIPS survey later
withdrew their participation once they
learned the costs of survey
administration. Providing information
on the cost of CMS-approved CAHPS for
MIPS survey vendor services may
support MIPS participants who are
interested in the CAHPS for MIPS
Survey but want to know what the costs
of administering the survey would be,
thus allowing them to make more
informed decisions about whether to
participate in the CAHPS for MIPS
survey. This would also increase the
consistency in requirements across
different types of third party
intermediaries.
If this proposal is finalized, the
CAHPS for MIPS Survey Vendor
Participation Form 784 and the CAHPS
for MIPS Survey Minimum Business
Requirements 785 in the QPP Resource
Library would be updated to detail the
784 2024 CAHPS for MIPS Survey Vendor
Participation Form, March 25, 2024. https://
qpp.cms.gov/resources/document/6386fe4b-49b942c8-9a2b-a1149f7b142a.
785 2024 CAHPS for MIPS Survey Vendor
Minimum Business Requirements, March 11, 2024.
https://qpp.cms.gov/resources/document/02e6e59651de-4336-a6a6-ab63fc639dbc.
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required survey vendor cost estimate
information. The CAHPS for MIPS
Survey Vendor Participation Form
submitted by vendors seeking CMS
approval would be updated to include
fields to report the cost information. The
vendor-specific cost information would
then be published in the list of CAHPS
for MIPS Survey Approved Vendors
which is also posted in the Resource
Library. We refer readers to section
V.B.8.c.(5) of this proposed rule for
discussion on the burden estimates for
this proposal.
We request comment on this proposal.
k. 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 the Department to
advance accountability and encourage
improvements in care. The Secretary
has also adopted the closely related goal
that all people with Original Medicare
be in an accountable care relationship
by 2030, so that their needs can be
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 the belief
that integrating individuals’ clinical
needs across a spectrum of clinicians
and settings will improve patient care
and population health.
As we continue to make
improvements to the Quality Payment
Program, we seek to develop, propose,
and implement policies that encourage
broad and meaningful clinician
participation, including by specialists,
in Advanced APMs.
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.
An attributed beneficiary is a
beneficiary attributed to the APM Entity
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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. 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.
In this section, we propose to modify
the definition of ‘‘attribution-eligible
beneficiary’’ to include any beneficiary
who has received a covered professional
service (section 1833(z)(3)(A) of the Act;
42 CFR 414.1305; section 1848(k)(3)(A)
of the Act) furnished by the eligible
clinician (NPI) for whom we are making
the QP determination. By no longer
specifying evaluation and management
(E/M) services as the default attribution
basis, we also would eliminate the need
to develop customized attribution bases
for Advanced APMs that do not use E/
M services as the basis for attribution.
Therefore, our proposal would
standardize the attribution methodology
for QP determinations by making
covered professional services the basis
for attribution across all Advanced
APMs.
(2) Payment Amount and Patient Count
Methods
The payment amount method for
calculating threshold scores 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
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‘‘attribution-eligible beneficiaries,’’ as
defined at § 415.1305.786
Attributed beneficiaries are those who
are attributed to the APM Entity (or
individual eligible clinician) 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 (listed below) 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, we
begin by calculating Threshold Scores
using the payment amount and patient
count methodologies. 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) calculated at the APM Entity or
individual eligible clinician level, as
applicable, meets or exceeds the
relevant QP threshold described at
§ 414.1430(a), the relevant eligible
clinician or clinicians (either the
individual eligible clinician or all those
on the APM Entity’s Participation List)
achieve QP status for such year.
FIGURE 5: QP Determination Calculation
Attributed beneficiaries
Our 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) provides
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 attribution-eligible
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 both 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 denominator when the terms of an
Advanced APM do not permit such
beneficiary to be attributed to such APM
Entity.
(a) Attributed Beneficiary
Under our regulation at § 414.1305,
we define an attribution-eligible
beneficiary as 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.
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 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
786 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 ‘‘2024 Learning Resources for
QP Status and APM Incentive Payment’’ materials
on the Quality Payment Program Resource Library
at qpp.cms.com.
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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 align with
the Advanced APM’s performance
period or attribution period, or for other
reasons. There may also 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
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methodologies and rules for our thencontemporaneous 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. We
chose to refer to E/M services as the
primary basis for purposes of
attribution-eligibility because many
Advanced APMs use E/M claims to
attribute beneficiaries to their APM
Entity groups. 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 ‘‘2024
Learning Resources for QP Status and
APM Incentive Payment’’ materials on
the Quality Payment Program Resource
Library at qpp.cms.gov.
We also included an exception in this
sixth criterion to allow us to use an
alternative approach for Advanced
APMs that do not base attribution 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 an 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 ‘‘2024
Learning Resources for QP Status and
APM Incentive Payment’’ materials on
the Quality Payment Program Resource
Library at qpp.cms.gov.
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
beneficiary populations and, ultimately,
so that our way of identifying
beneficiaries for purposes of Threshold
Score calculations for QP
determinations would be appropriate for
such Advanced APMs. That said, our
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thinking when we developed these
approaches was shaped by the form and
nature of the Advanced APMs that
existed at that time. We believed that,
by affording sufficient flexibility within
the program, we could both foster
innovation in Advanced APMs and
simplify our execution of the program.
However, with our more narrowly
defined default approach to beneficiary
attribution (relying on claims for E/M
services), we have increasingly needed
to exercise the flexibility to identify an
alternative approach to attribution
eligibility for Advanced APMs that fell
into the exception, which meant that we
identified several individually-tailored
ways of performing the attribution
methodology for specific Advanced
APMs. We anticipate that Advanced
APMs will continue to evolve and use
novel approaches to value-based care
that may emphasize a broad range of
covered professional services, and in
that event the application of our current
regulations may result in increased
variability among the ways we define
attribution-eligible when making QP
determinations, which frustrates our
goal of a consistent approach.
Further, we recognize that primary
care practitioners generally furnish a
higher proportion of E/M services than
do specialists for the same beneficiary.
The current reliance on E/M services for
attribution in our Threshold Score
calculations means that primary care
practitioners may contribute more
significantly to achieving QP status for
an APM Entity group. As such, our
current policy may have inadvertently
encouraged APM Entities to prefer
primary care practitioners over
specialists in their Participation Lists.
As discussed in the CY 2024 PFS final
rule (88 FR 79400 through 79406), we
proposed but did not finalize to revise
the definition of ‘‘attribution-eligible
beneficiary’’ at § 414.1305 to use
covered professional services as the
basis for attribution for purposes of
Threshold Score calculations for all
Advanced APMs regardless of the
attribution methodology used under the
specific Advanced APMs in which the
eligible clinician participates. We
expressed concern that the current
policy to use E/M services as the default
basis for attribution, and to use an
alternative approach for Advanced
APMs that use a different attribution
basis, could result in a complex set of
unique attribution approaches for
various Advanced APMs.
After further consideration and
consultation with interested parties, we
believe it would be appropriate to create
a uniform basis for beneficiary
attribution for purposes of Threshold
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Score calculations across all Advanced
APMs. We are once again 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,
beginning with the 2025 QP
performance period. By no longer
specifying a claim for E/M services as
the default attribution basis in the sixth
criterion, we also would eliminate the
need to create unique attribution bases
that are tied to a specific Advanced
APM’s attribution methodology. This
would standardize the attribution
methodology by basing attribution on
covered professional services across all
Advanced APMs.
The proposal would address the issue
discussed earlier in this section
whereby, under our current policy,
beneficiary attribution for purposes of
QP determinations in the default
methodology is contingent upon the
beneficiary receiving an E/M service,
and as a result, beneficiaries who are
actually furnished covered professional
services by eligible clinicians on an
APM Entity’s Participation List are not
attribution-eligible for purposes of the
QP determination if none of the services
are E/M services. Under our proposal,
we would consider all covered
professional services for purposes of
attribution, and not solely the limited
range of E/M services currently used for
attribution. As a result, we would be
able to include as attributed
beneficiaries those who are receiving
any services within the entire range of
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 and
would be consistent across all
Advanced APMs. Further, we believe
that the proposal better aligns the QP
determination methodology with the
universe of services to which the
Quality Payment Program (MIPS and
APMs) applies, noting that its
provisions generally pertain to covered
professional services (for example, its
financial incentives for both MIPS
eligible clinicians and QPs are applied
to covered professional services
payments).
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
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August 31, respectively) will 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. 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. Finally, we believe that the
proposal would standardize the
approach to QP determinations across
all Advanced APMs and conform more
closely with the scope of services that
are subject to the Quality Payment
Program. We also acknowledge that,
while this proposal would represent
significant progress toward rationalizing
attribution for the broader range of
Advanced APMs, our continued
analysis suggests there may be more
work to be done in this area. We believe
there still may be situations in which
the proposed change in attribution
policy would limit QP determinations
in certain Advanced APMs, particularly
in situations where an Advanced APM
is focused on a limited set of services.
We recognize the need to provide,
consistent with statutory requirements,
equitable opportunities to achieve QP
status for participants in Advanced
APMs that have different focus areas,
goals, scopes, and design features.
Further, in the case of CMS Innovation
Center models, we recognize that there
will be ongoing evolution and
innovation in the model tests that are
Advanced APMs, including the
development of new approaches to
attribution that apply within the
models. We will continue to analyze
these developments and issues with the
goal to provide for an equitable,
rational, transparent, and meaningful
methodology for QP determinations
across the full range of Advanced APMs.
We seek comment on this proposal to
revise the sixth criterion of the
definition of ‘‘attribution-eligible
beneficiary’’ at § 414.1305 to include a
beneficiary who has at least one claim
for a covered professional service
furnished by an eligible clinician who is
on the Participation List for the APM
Entity (or by the individual eligible
clinician, as applicable) at any
determination date during the QP
Performance Period. We also invite
comment more generally on potential
approaches we could consider to make
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QP determinations in the most
equitable, rational, transparent, and
meaningful way for eligible clinicians
across the broad range of Advanced
APMs, including Advanced APMs that
are focused on a limited set of services.
(3) 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 period 2017). The
All-Payer Combination Option, through
which QP status is calculated using the
Medicare Option in addition to an
eligible clinician’s participation in
Other Payer Advanced APMs, has been
applicable since payment year 2021
(performance period 2019). In the CY
2017 Quality 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 304(a)(2) of Division G, Title
I, Subtitle C, of the Consolidated
Appropriations Act, 2024 (CAA, 2024)
(Pub. L. 118–42, March 9, 2024)
amended section 1833(z)(2) of the Act
by extending for payment years 2025
and 2026 (performance periods 2023
and 2024) the applicable payment
amount and patient count thresholds for
an eligible clinician to achieve QP
status. Specifically, section 304(a)(2) of
the CAA, 2024, amended section
1833(z)(2) of the Act to continue the QP
payment amount thresholds that
applied in payment year 2025
(performance period 2023) to payment
year 2026 (performance period 2024).
Additionally, section 304(a)(2) of the
CAA, 2024, amended section 1833(z)(2)
of the Act to require that, for payment
year 2026, 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
2026 will remain at 50 percent for the
payment amount method and 35 percent
for the patient count method. Section
304(b) of the CAA, 2024, also amended
section 1848(q)(1)(C)(iii) of the Act to
extend through payment year 2026 the
Partial QP thresholds that were
established beginning for payment year
2021 under the Medicare Option.
Therefore, the Partial QP thresholds for
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payment year 2026 (performance period
2024) 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 2026 (performance period 2025)
will remain at 50 percent for the
payment amount method and 35 percent
for the patient count method. The
Partial QP thresholds for payment year
2026 (performance period 2024) will
continue at 40 percent for the payment
amount method and 25 percent for the
patient count method. 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 2026 (performance
period 2024), 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 for 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
for the payment amount method or 10
percent for the patient count method.
To conform our regulation with the
amendments made by the CAA, 2024,
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 2026 (performance period 2024).
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:
• Paragraph (a)(1)(v) to state that for
2026 the amount is 50 percent, and a
new paragraph (a)(1)(vi) to state that for
2027and later, the amount is 75 percent.
• Paragraph (a)(2)(v) to state that for
2026 the amount is 40 percent, and a
new paragraph (a)(2)(vi) to state that for
2027 and later, the amount is 50
percent.
• Paragraph (a)(3)(v) to state that for
2026 the amount is 35 percent, and a
new paragraph (a)(3)(vi) to state that for
2027 and later, the amount is 50
percent.
• Paragraph (a)(4)(v) to state that for
2026 the amount is 25 percent, and a
new paragraph (a)(4)(vi) to state that for
2027 and later, the amount is 35
percent.
• Paragraph (b)(1)(i)(A) to state that
for 2021 through 2026 the amount is 50
percent, and paragraph (b)(1)(i)(B) to
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• Paragraph (b)(3)(i)(A) to state that
for 2021 through 2026 the amount is 35
percent, and paragraph (b)(3)(i)(B) to
state that for 2027 and later, the amount
is 50 percent.
• Paragraph (b)(4)(i)(A) to state that
for 2021 through 2026 the amount is 25
state that for 2027 and later, the amount
is 75 percent.
• Paragraph (b)(2)(i)(A) to state that
for 2021 through 2026 the amount is 40
percent and paragraph (b)(2)(i)(B) to
state that for 2027 and later, the amount
is 50 percent.
percent, and paragraph (b)(4)(i)(B) to
state that for 2027 and later, the amount
is 35 percent.
TABLE 74: QP Threshold Score Updates
Medicare Ootion - Payment Amount Method
QP Performance
Period / Payment
Year
QPPayment
Amount Threshold
Partial QP Payment
Amount Threshold
2022/2024
(Percent)
2023/2025
(Percent)
2024/2026
(Percent)
2025/2027 and later
(Percent)
50
50
50
75
40
40
40
50
Medicare Ootion - Patient Count Method
QP Performance
Period / Payment
Year
QP Patient Count
Threshold
Partial QP Patient
Count Threshold
2022/2024
(Percent)
2023/2025
(Percent)
2024/2026
(Percent)
2025/2027 and later
(Percent)
35
35
35
50
25
25
25
35
All-Payer Combination Option - Pavment Amount Method
2022/2024
(Percent)
50
25
50
25
75
25
40
20
40
20
40
20
50
20
Medicare
Medicare
Medicare
Total
Total
Total
Minimum
Minimum
Minimum
All-Payer Combination Option - Patient Count Method
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2023/2025
(Percent)
2022/2024
(Percent)
Medicare
Minimum
2025/2027 and later
(Percent)
2024/2026
(Percent)
35
20
35
20
35
20
50
20
25
10
25
10
25
10
35
10
Total
Medicare
Minimum
Total
Medicare
Minimum
Prior to amendments made by section
304(a)(1) of the CAA, 2024, 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 2025. 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
20:32 Jul 30, 2024
2025/2027 and later
(Percent)
25
(4) APM Incentive Payment
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(Percent)
50
Total
QP Performance
Period / Payment
Year
QP Patient Count
Threshold
Partial QP Patient
Count Threshold
2023/2025
(Percent)
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Total
eligible clinician who is determined to
be a QP for such year, 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’’) in each
payment year from 2019 through 2024,
and 3.5 percent of such amounts in
payment year 2025. Covered
professional services is defined at
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Medicare
Minimum
Total
Medicare
Minimum
§ 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).
Section 304(a) of the CAA, 2024
amended section 1833(z)(1) of the Act to
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QP Performance
Period/ Payment
Year
QP Patient Count
Threshold
Partial QP Patient
Count Threshold
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provide that eligible clinicians who are
QPs with respect to payment year 2026
(performance period 2024) will receive
an APM Incentive Payment equal to
1.88 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 1.88
percent.
Accordingly, we propose to
incorporate the change made by the
CAA, 2024, by amending the regulation
text at § 414.1450 to add the payment
year 2026 APM Incentive Payment
amount of 1.88 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,
for payment year 2025, 3.5 percent, and
for payment year 2026, 1.88 percent of
the estimated aggregate payments for
covered professional services furnished
during the calendar year immediately
preceding the payment year.
Beginning with 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 an eligible
clinician who is a QP for the year (the
qualifying APM conversion factor), and
the other for other items and services
not furnished by a QP (the
nonqualifying APM conversion factor).
Each conversion factor will be equal to
the conversion factor for the previous
year multiplied by the applicable
update for the year specified in section
1848(d)(20) of the Act. The update
specified for the qualifying APM
conversion factor for CY 2025 is 0.75
percent, while the update for the
nonqualifying APM conversion factor is
0.25 percent.
V. Collection of Information
Requirements
Under the Paperwork Reduction Act
of 1995 (PRA) (44 U.S.C. 3501 et seq.),
we are required to provide 60-day notice
in the Federal Register and solicit
public comment before a ‘‘collection of
information’’ requirement (as defined
under 5 CFR 1320.3(c) of the PRA’s
implementing regulations) is submitted
to the Office of Management and Budget
(OMB) for review and approval. To
fairly evaluate whether a collection of
information should be approved by
OMB, section 3506(c)(2)(A) of the PRA
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 estimate of the
information collection burden.
• The quality, utility, and clarity of
the information to be collected.
• Recommendations to minimize the
information collection burden on the
affected public, including automated
collection techniques.
We are soliciting public comment (see
section VI. of this proposed rule) on
each of the aforementioned issues for
the following sections of this document
that contain information collection
requirements (ICRs). Comments, if
received, will be responded to within
the subsequent final rule.
A. Wage Estimates
To derive average costs, we used data
from the U.S. Bureau of Labor Statistics’
(BLS) May 2023 National Occupational
Employment and Wage Estimates for all
salary estimates (https://bls.gov/oes/
2023/may/oes_nat.htm). In this regard,
Tables 75 and 76 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.
We note that the May 2023 BLS data
does not include median hourly wage
rates for a number of the physician
occupation types listed in Table 76; in
these cases, the BLS identifies that the
median wage rate is equal to or greater
than $115.00/hr or $239,200 per year.
BLS data for prior years, such as the
May 2021 and May 2022 data, provide
similar notes for median wage rates for
occupations that are above a given
threshold ($100.00/hr or $208.000 per
year for the May 2021 BLS data (https://
www.bls.gov/oes/2021/may/oes_
nat.htm), and $115.00/hr or $239,200
per year for the May 2022 BLS data
(https://www.bls.gov/oes/2022/may/
oes_nat.htm)). Therefore, for
consistency with previous years for
estimating physician wage rates, we
have continued to use mean hourly
wage rates across our wage estimates.
TABLE 75: National Occupational Employment and Wage Estimates
(Excluding Physicians)
Occupation Title
Fringe Benefits
and Other
Indirect Costs
Occupation Code
Mean Hourly
Wage ($/hr)
Adjusted Hourly
Wage ($/hr)
43-3021
15-1211
11-1011
23-1011
29-2061
22.66
53.27
124.47
84.84
29.23
22.66
53.27
124.47
84.84
29.23
45.32
106.54
248.94
169.68
58.46
11-9111
64.64
64.64
129.28
29-1051
64.81
64.81
129.62
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Computer System Analysts
Chief Executives
Lawyers
Licensed Practical and
Licensed Vocational Nurses
Medical and Health Services
Managers
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For our purposes, BLS’ May 2023
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
62103
average conglomerate wage of $291.64/
hr as demonstrated below in Table 76.
TABLE 76: National Occupational Employment and Wage Estimates
(Physicians)
Occupation Code
Mean Hourly
Wage ($/hr)
29-1211
29-1215
163.21
115.77
Anesthesiologists
Family Medicine
Physicians
General Internal
Medicine Physicians
Obstetricians and
Gynecologists
Orthopedic Surgeons,
Except Pediatric
Pediatric Surgeons
Pediatricians, General
Physicians, All Other
Psychiatrists
Surgeons
Surgeons, All Other
Total
Average Physician
Wage (3,207.98/11)
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326.42
231.54
118.01
118.01
236.02
133.97
133.97
267.94
181.85
216.02
98.97
119.54
123.53
167.74
165.38
181.85
216.02
98.97
119.54
123.53
167.74
165.38
363.7
432.04
197.94
239.08
247.06
335.48
330.76
3,207.98
291.64
29-1218
29-1242
29-1243
29-1221
29-1229
29-1223
29-1240
29-1249
1. ICRs Regarding Clinical Laboratory
Fee Schedule: Revised Data Reporting
Period and Phase-In of Payment
Reductions (§ 414.504)
On November 17, 2023, section 502 of
the Further Continuing Appropriations
and Other Extensions Act, 2024 (Pub. L.
118–22) (FCAOEA, 2024) was passed
and delayed data reporting requirements
for CDLTs that are not ADLTs, and it
also delayed the phase-in of payment
reductions under the CLFS from private
payor rate implementation under
section 1834A of the Act. 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.’’ We are proposing to
revise § 414.504(a)(1) to account for a
delay in reporting until January 1, 2025,
through March 31, 2025. 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,
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Adjusted Houri~
Wage ($/hr)
29-1216
B. Proposed Information Collection
Requirements (ICRs)
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Fringe Benefits
and Other Indirect
Costs ($/hr)
163.21
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we are not setting out any proposed
burden estimates under this section of
this proposed rule. Please refer to
section VII.XX. of this proposed rule for
a discussion of the impacts associated
with the proposed changes described in
section III.D. of this proposed rule.
2. ICRs Regarding the Updates to the
Medicare Diabetes Prevention Program
In section § 410.79(b), we are
proposing to make conforming changes
to our regulation Conditions of Coverage
to align with the 2024 Centers for
Disease Control and Prevention (CDC)
Diabetes Prevention Recognition
Program (DPRP) Standards.787 We are
proposing to amend § 410.79(b) to add
a new term for MDPP, ‘‘in-person with
a distance learning component.’’ The
proposed ‘‘in-person with a distance
learning component’’ code will reduce
administrative burden and allow MDPP
suppliers to streamline data reporting to
CDC because they will only have to
maintain one code if they are providing
in-person and distance learning
787 Centers for Disease Control and Prevention
Diabetes Prevention Recognition Program.
Standards and Operating Procedures. Requirements
for CDC Recognition. June 2024. https://
nationaldppcsc.cdc.gov/s/article/DPRP-Standardsand-Operating-Procedures.
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delivery. To further align with 2024
CDC DPRP Standards, we are also
adding the term ‘‘combination with an
online component’’ and revising the
current ‘‘online’’ definition. We are also
clarifying in § 410.79(d)(1) that MDPP
make-up sessions can only be furnished
using distance learning and in-person
delivery modes, in alignment with the
Extended flexibilities as defined in the
CY 2024 PFS final rule (88 FR 79528).
We are also proposing to amend
§ 410.79(e)(3)(iii)(C) in response to
comments that beneficiaries are unable
to take a picture while standing on their
home scales due to risk of injury and
physical health limitations (88 FR
79249). We are proposing revised
language to specify that a beneficiary
can self-report their weight for an MDPP
distance learning session by sending 2
(two) date-stamped photos: one with
their weight on the digital scale and one
of the beneficiary visible in their home.
Additionally, at § 414.84(c), to make it
possible for Medicare Administrative
Contractors (MACs) to process claims
for same day make-up sessions in
MDPP, we are proposing that suppliers
be required to append an existing claim
modifier (Current Procedural
Terminology (CPT) Modifier 79) to any
claim for G9886 or G9887 to indicate a
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make-up session that was held on the
same day as a regularly scheduled
MDPP session. We are proposing to
remove the MDPP bridge payment in
§ 414.84(a), (d), and (e). This payment is
no longer necessary in MDPP’s CY 2024
fee for service payment structure and
could introduce the potential for fraud,
waste, or abuse. Finally, we are
proposing to make minor edits
throughout §§ 410.79, 424.205, and
414.84 to update outdated references
and align with previous rulemaking
pertaining to MDPP terminology,
payment structure, and requirements.
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, including the
collection of weights, per the CY 2024
PFS final rule.
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.11. 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 Rebate Reduction
Requests Submitted Under Sections
11101 and 11102 of the Inflation
Reduction Act
The following proposed changes will
be submitted to OMB for review under
control number 0938–NEW (CMS–
10858).
As described in section III.I. of this
proposed rule, to receive consideration
for an inflation rebate reduction for a
specific rebatable drug when the
manufacturer believes there is a severe
supply chain disruption or likely
shortage, we are proposing that a
manufacturer must submit a rebate
reduction request form along with
supporting documentation. We are
proposing this because manufacturers
hold some of the information and
documentation that is needed to
determine whether the rebate amount
for a Part B or Part D rebatable drug
should be reduced due to either a severe
supply chain disruption or a likely
shortage as required by sections
1847A(i)(3)(G)(ii), 1860D–
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14B(b)(1)(C)(ii), and 1860D–
14B(b)(1)(C)(iii) of the Act.
In §§ 427.402(c)(4) and 428.302(c)(4),
we are proposing the criteria that a Part
B or Part D rebatable drug would have
to meet for CMS to grant a severe supply
chain disruption rebate reduction
request. In §§ 427.402(c)(5) and
428.302(c)(5), we propose that if a
manufacturer believes a severe supply
chain disruption continues into a fifth
consecutive calendar quarter for a Part
B rebatable biosimilar biological
product, or a second applicable period
for a generic Part D rebatable drug or
biosimilar after the start of the natural
disaster or other unique or unexpected
event, the manufacturer may request an
extension of the rebate reduction one
time by submitting a rebate reduction
extension request and supporting
documentation. In § 428.303(c)(4), we
propose the criteria that a generic Part
D rebatable drug would have to meet for
CMS to grant a rebate reduction request
because the generic Part D rebatable
drug is likely to be in shortage,
including the requirements for a onetime extension of a rebate reduction.
Outside of this proposed rule we have
proposed additional submission
requirements for rebate reduction
requests under OMB control number:
0938–NEW (CMS–10858). At this time,
the rebate reduction request forms are
currently going through the PRA review
and approval process. The 30-day notice
appeared in the Federal Register on
June 3, 2024 (89 FR 47563).
We believe that few manufacturers
will submit a rebate reduction request
form due to the statutory specifications
regarding eligible rebatable drugs, as
well as the policy criteria proposed in
this proposed rule. Using the wage rates
in Table 75 of this proposed rule, we
anticipate collecting a total of 10 rebate
reduction request forms per year. We
estimate a total annual burden of 310
hours (31 hrs per form * 10 forms) and
total annual cost of $37,378 ((160 hrs ×
$84.66/hr) + (80 hrs × $129.62/hr) + (50
hrs × $169.68/hr) + (20 hrs × $248.94/
hr)).
Using the wage rates in Table 75 of
this proposed rule, we also anticipate
collecting a total of 10 rebate reduction
extension request forms per year, and a
total annual burden estimate of 310
hours (31 hr per form * 10 forms) at a
cost of $37,378 ((160 hrs × $84.66/hr) +
(80 hrs × $129.62/hr) + (50 hrs ×
$169.68/hr) + (20 hrs × $248.94/hr)).
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5. ICRs Regarding Medicare Parts A and
B Overpayment Provisions of the
Affordable Care Act (§ 401.305(b)(1), (2),
and (3))
Existing § 401.305(b)(1) specifies
when a person who has received an
overpayment must report and return an
overpayment. We propose to amend this
regulation to reference revised
§ 401.305(b)(2) and new § 401.305(b)(3).
We are proposing a technical
modification to the introductory
language in § 401.305(b)(2) to
acknowledge that this paragraph may be
applicable after the suspension
described in new § 401.305(b)(3) is
complete. New proposed § 401.305(b)(3)
would identify the circumstances under
which the deadline for reporting and
returning overpayments would be
suspended to allow time for providers to
investigate and calculate overpayments.
The proposed amendments for
Medicare Parts A and B are associated
with OMB control number 0938–1323
(CMS–10405); however, we are not
making any revisions to the currently
approved requirements and burden
under this control number since we
cannot predict if there will be any
change to the number of overpayments
identified or reported based on this
rulemaking’s proposed changes. We
solicit comment on this assumption.
6. The Quality Payment Program (42
CFR Part 414 and Section IV of This
Proposed Rule)
The following Quality Payment
Program-specific ICRs reflect changes to
our currently approved burden to
capture proposed policy changes in this
CY 2025 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), and the CY
2019, CY 2020, CY 2021, CY 2022, CY
2023, and CY 2024 Physician Fee
Schedule (PFS) final rules (83 FR 59452,
84 FR 62568, 85 FR 84472, 86 FR 64996,
87 FR 70131, and 88 FR 78818,
respectively) due to revised
assumptions based on updated data
available at the time of the publication
of this proposed rule.
As described in the CY 2017 and CY
2018 Quality Payment Program final
rules (81 FR 77008 and 82 FR 53568,
respectively), and the CY 2019, CY
2020, CY 2021, CY 2022, CY 2023, and
CY 2024 Physician Fee Schedule (PFS)
final rules (83 FR 59452, 84 FR 62568,
85 FR 84472, 86 FR 64996, 87 FR 70131,
and 88 FR 78818, respectively), we have
used an exhaustive approach for
describing the burden associated with
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the MIPS requirements for the Quality
Payment Program. With the maturity
and stabilization of the Quality Payment
Program, we believe there may be
opportunities to present streamlined
annual burden estimates to account for
changes, including changes due to
proposed policies. We are soliciting
public comment as part of this proposed
rule on our exhaustive approach to
presenting burden estimates associated
with the Quality Payment Program.
a. Background
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(1) ICRs Associated With Merit-Based
Incentive Payment System (MIPS) and
Advanced Alternative Payment Models
(APMs)
In this section of this proposed rule,
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 2025 PFS
proposed rule and proposed revisions to
our currently approved information
requests for MIPS and Advanced APM
ICRs. The proposed changes will be
submitted to OMB for review under
control number 0938–1314 (CMS–
10621). In the CY 2024 PFS final rule
(88 FR 79446 and 79447), we provided
updated burden estimates for the
information collections under the
Consumer Assessment of Healthcare
Providers and Systems (CAHPS) for
MIPS Survey PRA package. We have
submitted these burden estimates to
OMB for approval under control number
0938–1222 (CMS–10450): the 60-day
notice appeared in the Federal Register
on October 17, 2023 (88 FR 71573),
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while the 30-day notice appeared on
January 16, 2024 (89 FR 2622). The
updated information collections for the
CAHPS for MIPS Survey discussed in
section IV.A.4.j. of this proposed rule
will be submitted to OMB for review
under control number 0938–1222
(CMS–10450) if the related policy
proposal is finalized in the CY 2025 PFS
final rule, to be a requirement for
CAHPS for MIPS survey vendors
beginning with the CY 2026
performance period/2028 MIPS
payment year. We note that we have
received approval for the collection of
information associated with the virtual
election process under OMB control
number 0938–1343 (CMS–10652).
(a) Summary of Annual Quality
Payment Program Burden Estimates
Table 77 summarizes this proposed
rule’s total burden estimates for the
Quality Payment Program for the CY
2025 performance period/2027 MIPS
payment year. We provide details of the
proposed policies, updated
assumptions, and ICRs beginning in
section V.B.8. of this proposed rule.
In the CY 2024 PFS final rule (87 FR
70169), the total estimated burden for
the CY 2024 performance period/2026
MIPS payment year was 724,212 hours
at a cost of $81,322,556 (see Table 77,
row a). Accounting for updated wage
rates and the subset of all Quality
Payment Program ICRs outlined in this
proposed rule compared to the CY 2024
PFS final rule, the total estimated
annual burden of continuing policies
and information set forth in the CY 2024
PFS final rule into the CY 2025
performance period/2027 MIPS
payment year is 727,906 hours at a cost
of $85,867,252 (see Table 77, row b).
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62105
These represent an increase of 3,694
hours and an increase of $4,544,696.
To understand the burden
implications of the policies proposed in
this rulemaking, we provided an
estimate of the total burden associated
with continuing the policies and
information collections set forth in the
CY 2024 PFS final rule into the CY 2025
performance period/2027 MIPS
payment year. The estimated burden of
657,110 hours at a cost of $77,779,594
(see Table 77, row c) reflects the
availability of more accurate data to
account for all potential respondents
and submissions across all the
performance categories and represents a
decrease of 70,796 hours and $8,087,658
(see Table 77, row d).
Our total proposed burden estimate
for the CY 2025 performance period/
2027 MIPS payment year is 649,540
hours and $76,866,418 (see Table 77,
row e), which represents a decrease of
78,366 hours and $9,000,834 from the
CY 2024 PFS final rule estimate with
updated wage rates and ICRs (see Table
77, row f). From these estimates,
updated data and assumptions not
related to policies proposed in this
proposed rule would reduce burden by
70,796 hours and $8,087,658. We
estimate that the policies proposed in
this proposed rule would further reduce
burden by 7,570 hours (¥78,366 hours
¥¥70,796 hours) and $913,176
(¥$9,000,834 ¥¥$8,087,658) (see
Table 77, row g) between this estimate
and the total burden shown in Table 78
is the decrease in burden associated
with impacts of the policies proposed
for the CY 2025 performance period/
2027 MIPS payment year.
BILLING CODE P
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Burden Estimate Description
Time (Hours)
Cost
Currently Approved Burden in CY 2024 PFS Final Rule (a)
724,212
$81,322,556
CY 2024 PFS Final Rule w/ Updated Wage Rates and ICRs (b)
727,906
$85,867,252
CY 2024 PFS Final Rule w/ Updated Data and Assumptions (c)
657,110
$77,779,594
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TABLE 77: Summary of Burden Estimates and Requirements from the CY 2025
PFS Proposed Rule
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Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
TABLE 78: Summary of Quality Payment Program Burden Estimates and Requirements
CMS-10621 (0MB 0938-1314)
Currently
Approved
Responses
Responses
44
39
-5
418
Total
Time
(Hours)
467
12
17
+5
138
238
+100
84
76
-8
42
38
-4
27
30
+3
54
60
+6
126
89
-37
499
472
-27
6,500
6,237
-263
6,500
6,237
-263
13,413
12,197
-1,216
190,465
173,197
-17,268
16,632
17,008
+376
151,068
154,484
+3,416
28,714
27,179
-1,535
229,712
217,432
-12,280
9,585
6,285
-3,300
2,396
1,571
-825
9,585
6,285
-3,300
61,662
40,193
-21,469
31
16
-15
171
88
-83
§ 414.1400 Qualified Clinical
Data Registry (QCDR)
Simplified Self-Nomination and
other Requirements (see Tables
81 and 82)
§ 414.1400 QCDRFull SelfNomination and other
Requirements (see Tables 83 and
84)
§ 414.1400 Qualified Registry
Simplified Self-Nomination and
other Requirements (see Tables
85 and 86)
§ 414.1400 Qualified Registry
Full Self-Nomination and other
Requirements (see Tables 87 and
88)
§ 414.1400 Third Party
Intermediary Plan Audits (see
Tables 90 and 91)
Quality Payment Program
Identity Management
Application Process (see Tables
95 and 96)
§§ 414.1325 and414.1335
Quality Performance Category:
Medicare Part B Claims
Collection Type (see Tables 97
and 98)
§§ 414.1325 and414.1335
Quality Performance Category:
QCDR/MIPS Clinical Quality
Measure CQM Collection Type
(see Tables 99 and I 00)
§§ 414.1325 and414.1335
Quality Performance Category:
electronic Clinical Quality
Measure eCQM Collection Type
(see Tables 10 I and I 02)
§414.1365 MVP Registration
(see Tables 103 and 104)
MVP Quality Submission (see
Tables I 05 and I 06)
Call for Quality Measures (see
Tables I 07 and I 08)
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1807-P
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Change in
Responses
Currently
Approved
Total Time
(Hours)
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1807-P
Change
in Total
Time
(Hours)
+49
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Requirement
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Requirement
Currently
Approved
Responses
CMS1807-P
Responses
Change in
Responses
Currently
Approved
Total Time
(Hours)
§ 414.13 80(c)(2) Reweighting
Applications for MIPS
Performance Categories (see
Tables 109 and 110
§ 414.1375 Data Submission for
Promoting Interoperability
Performance Category (see
Tables 112 and 113
§ 414.1360 Data Submission for
the Improvement Activities
Performance Category (see
Tables 115 and 116
§§ 414.1310(b) and 414.1430
Partial Qualifying APM
Participant (QP) Elections (see
Tables 117 and 118
§ 414.1445 Other Payer
Advanced APM Determinations:
Payer-Initiated Process (see
Tables 119 and 120
§ 414.1445 Other Payer
Advanced APM Determinations:
Eligible Clinician-Initiated
Process (see Tables 121 and
122
§ 414.1440 Submission of Data
for QP Determinations under the
All-Payer Combination Option
see Tables 123 and 124
29,227
3,297
-25,930
25,990
18,609
50,289
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-7,381
70,173
50,244
-19,929
38,433
-11,856
4,174
3,190
-984
287
18
-269
72
5
-67
15
10
-5
150
100
-50
15
10
-5
150
100
-50
551
120
-431
2,755
600
-2, 155
Program segment of this proposed rule.
We divided the reasons for our change
in burden into those related to proposed
policies in the CY 2025 PFS proposed
rule and those related to adjustments in
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-6,483
burden continued from the CY 2024 PFS
final rule policies that reflect updated
data and revised methods.
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Table 79 provides the reasons for
changes in the estimated burden for the
CY 2025 performance period/2027 MIPS
payment year for information
collections in the Quality Payment
Change
in Total
Time
(Hours)
7,307
CMS1807-P
Total
Time
(Hours)
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62109
TABLE 79: Reasons for Proposed Change in Burden Compared to The Currently
Approved CY 2024 Information Collection Burden
Changes in Burden Due to CY
2025 Proposed Ruic Policies
Adjustments in Burden Continued
from CY 2024 PF'S Final Ruic
Policies Due to Revised Methods or
lJ pdated Data
Decrease in number of respondents and
increase in the number of hours per
respondent due to updated data.
Net increase in the total number of
hours due to updated data.
Increase in number of respondents and
increase in the number of hours per
respondent due to updated data.
Net increase in the total number of
hours due to updated assumptions for
the CY 2025 performance period/2027
MIPS payment year.
Decrease in number of respondents due
to updated data.
QCDR Simplified SelfNomination and other
Requirements (See Table 82)
None
QCDR Full Self-Nomination and
other Requirements (See Table
84)
None
Qualified Registry Simplified SelfNomination and other
Requirements (See Table 86)
None
Qualified Registry Full SelfNomination and other
Requirements (See Table 88)
Third Party Intermediary Plan
Audits (see Table 91)
Quality Payment Program Identity
Management Application Process
(see Table 96)
Quality Performance Category:
Medicare Part B Claims Collection
Type (see Table 98)
None
Increase in number of respondents due
to updated data.
None
Decrease in number of respondents due
to updated data.
Decrease in number of respondents due
to updated data.
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None
Decrease in number of
respondents due to the estimated
increase in the number of
respondents submitting for the
MVP quality performance
category via the claims
collection type due to the
proposed addition of 6 new
MVPs.
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Decrease in the number of respondents
due to updated data.
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Changes in Burden Due to CY
2025 Proposed Rule Policies
Decrease in number of
respondents due to the estimated
increase in the number of
respondents submitting for the
MVP quality performance
category via the QCDR and
MIPS CQM collection type due
to proposed addition of new
MVPs.
Decrease in number of
respondents due to the estimated
increase in the number of
respondents submitting for the
MVP quality performance
category via the eCQM
collection type due to proposed
addition of 6 new MVPs.
Increase in number of
respondents due to proposed
addition of 6 new MVPs.
Increase in number of
respondents due to proposed
addition of 6 new MVPs.
None
Quality Performance Category:
QCDR/MIPS CQM Collection
Type (see Table 100)
Quality Performance Category:
eCQM Collection Type (see Table
102)
MVP Registration (see Table 104)
MVP Quality Submission (see
Table 106)
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Call for Quality Measures (see
Table 108)
Reweighting Applications for
MIPS Performance Categories (see
Table 110)
Data Submission for the Promoting
Interoperability Performance
Category (see Table 113)
Data Submission for the
Improvement Activities
Performance Category (see Table
116)
Partial QP Elections (see Table
118)
Other Payer Advanced APM
Determinations: Payer-Initiated
Process (see Table 120)
Other Payer Advanced APM
Detenninations: Eligible ClinicianInitiated Process (see Table 122)
Submission of Data for QP
Determinations under the AllPayer Combination Option (see
Table 124)
BILLING CODE C
(2) Summary of Proposed Changes for
the Quality Payment Program: MIPS
We have included the change in the
estimated burden for the CY 2025
performance period/2027 MIPS
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None
Adjustments in Burden Continued
from CY 2024 PFS Final Rule
Policies Due to Revised Methods or
Updated Data
Increase in the number of respondents
due to updated data.
Decrease in the number of respondents
due to updated data.
Decrease in the number of respondents
due to updated data.
Decrease in the number of respondents
due to updated data.
Decrease in number ofrespondents due
to updated data.
Decrease in number of respondents due
to updated data.
None
Decrease in number ofrespondents due
to updated data.
None.
Decrease in number of respondents due
to updated data.
None
Decrease in number of respondents due
to uodated data.
Decrease in number of respondents due
to updated data.
None
None
Decrease in number of respondents due
to updated data.
None
Decrease in number of respondents due
to updated data.
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 2025
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performance period/2027 MIPS
payment year.
The following five MIPS ICRs show
changes in burden due to the proposed
policies in this proposed rule: (1)
Quality performance category data
submission by Medicare Part B claims
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ICR Title
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collection type; (2) Quality performance
category data submission by qualified
clinical data registry (QCDR) and MIPS
clinical quality measure (CQM)
collection type; (3) Quality performance
category data submission by electronic
clinical quality measure (eCQM)
collection type; (4) MIPS Value
Pathways (MVP) quality performance
category submission, and (5) MVP
registration. In aggregate, we estimate
the proposed policies would result in a
net decrease in burden of 7,570 hours
and $913,176 for the CY 2025
performance period/2027 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 preparation of this proposed
rule.
We are not proposing any changes or
adjustments to the following ICRs:
Registration for virtual groups; CAHPS
survey vendor requirements; CAHPS
beneficiary burden; group registration
for the CAHPS survey; call for
Improvement Activities; Open
Authorization (OAuth) credentialing
and token request process; nomination
of MVPs; subgroup registration; and optout of performance data display on
Compare Tools for voluntary
participants. See section V.B.8.a.(1). 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.
We incorporate submission data from
CY 2022 performance period/2024 MIPS
payment year to calculate the total
burden for data submission under the
quality, Promoting Interoperability, and
improvement activities performance
categories. The accuracy of our
estimates of the total burden for data
submission for those performance
categories may be impacted by several
primary factors. First, we are unable to
predict with absolute certainty who will
be a Qualifying APM Participant (QP)
for the CY 2025 performance period/
2027 MIPS payment year. Newly
eligible clinician participants in
Advanced APMs who become QPs will
be excluded from MIPS 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 2025
performance period/2027 MIPS
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payment year compared to the CY 2022
performance period/2024 MIPS
payment year. Therefore, the actual
number of Advanced APM participants
and how they elect to submit data may
differ from our estimates. However, we
believe our estimates are the most
appropriate given the available data. We
will continue to revise our estimates as
updated data becomes available.
In the CY 2024 PFS final rule, we
finalized requirements to align the
Shared Savings Program’s certified
electronic health record technology
(CEHRT) requirements with MIPS
Promoting Interoperability (88 FR 79124
through 79131), codified at § 425.507(a)
and (b). For performance years
beginning on or after January 1, 2025,
unless otherwise excluded, an
Accountable Care Organization (ACO)
participant, ACO provider/supplier, and
(ACO) professional that is a MIPS
eligible clinician, Qualifying APM
Participant (QP) and Partial Qualifying
APM Participant (Partial QP), regardless
of track must report the MIPS Promoting
Interoperability measures and
requirements to MIPS according to
§ 414(o) at the individual, group, virtual
group, or APM entity level, and earn a
MIPS performance category score for the
MIPS Promoting Interoperability
performance category at the individual,
group, virtual group, or APM entity
level, barring an applicable exclusion
defined at § 425.507(b). We refer readers
to the CY 2024 PFS final rule (88 FR
79124 through 79131) for details. We
note we are not updating burden
estimates for the Promoting
Interoperability performance category to
reflect requirements for ACO
participants who are not MIPS eligible
clinicians. Section 1899(e) of the Act
provides that chapter 35 of title 44 of
the U.S.C., which includes such
provisions as the PRA, shall not apply
to the Shared Savings Program. In
section V.B.8.e.(7). of this proposed
rule, we provide our burden estimates
for the Promoting Interoperability
performance category for MIPS eligible
clinicians.
(3) Summary of Quality Payment
Program Changes: Advanced APMs
For these ICRs, we are proposing
adjustments to the currently approved
burden estimates for the CY 2025
performance period/2027 MIPS
payment year based on updated
submission trends: Partial QP elections;
Other Payer Advanced APM
determinations: Payer-Initiated and
Eligible Clinician-initiated processes;
and submission of Data for QP
Determinations under the All-Payer
Combination Option.
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62111
(4) Framework for Understanding the
Burden of MIPS Data Submission
Because of the wide range of
information collection requirements
under MIPS, Table 80 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 80, MIPS eligible clinicians and
other clinicians voluntarily submitting
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 for the CY 2023 and 2024 MIPS
performance periods/2025 and 2026
MIPS payment years, 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 and
65414). As discussed in section
IV.A.4.b.(1)(4). of this proposed rule, we
are proposing to clarify that we intend
for the policy to apply beyond the CY
2023 and 2024 performance periods/
2025 and 2026 MIPS payment years. We
refer readers to section V.B.8.g.(3). of
this proposed rule for our burden
estimates for the Promoting
Interoperability performance category.
Because MIPS eligible clinicians are
not required to submit any additional
information for assessment under the
cost performance category, the
administrative claims data used to
calculate the scores for the cost
performance category is not represented
in Table 80.
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 (APP) is available
for clinicians who participate in a MIPS
APM for both 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 APP versus
the traditional MIPS submission
mechanism for the CY 2025
performance period/2027 MIPS
payment year, we assume Shared
Savings Program ACO APM Entities will
submit quality data through the APP as
required, and MIPS eligible clinicians in
non-Shared Savings Program ACO APM
Entities will participate through
traditional MIPS or MVPs, submitting as
an individual or group rather than as an
APM Entity. Per section 1899(e) 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. Accordingly, this burden is not
included in Quality Payment Program
burden estimates.
In the CY 2021 PFS final rule (85 FR
84860 and 84861), we adopted the
current APP quality measure set. As
discussed in section IV.A.4.c.(2). of this
proposed rule, we are proposing to
create the APP Plus quality measure set
that would allow for alignment of the
APP with the Adult Universal
Foundation measures. Under this
proposal, Shared Savings Program ACOs
would be required to report the APP
Plus quality measure beginning with the
CY 2025 performance period/2027 MIPS
payment year. We are not proposing to
modify the existing APP quality
measure set of six quality measures;
instead, we are proposing to create the
APP Plus measure set that would be
optional, with exception to the Shared
Savings Program ACOs, beginning in the
CY 2025 performance period/2027 MIPS
payment year. Under this proposal, each
MIPS eligible clinician, group, or APM
Entity that elects to report the APP may
choose to report either the APP quality
measure set or the APP Plus quality
measure set. MIPS APM participants
may also elect to report via traditional
MIPS or MVPs.
We are proposing to adopt five new
quality measures for the APP Plus
quality measure set incrementally over
several performance periods/MIPS
payment years, as detailed in Tables 55,
56, and 57 in section IV.A.4.c.(3)(f): two
new quality measures beginning with
the CY 2025 performance period; one
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new quality measure beginning with the
CY 2026 performance period, and two
new quality measures beginning with
the CY 2028 performance period. We
refer readers to section IV.A.4.c.(3). of
this proposed rule for additional details
on the proposed measures and
collection types of the APP Plus quality
measure set. As noted in section
IV.A.4.c.(3). of this proposed rule, we
are proposing to establish that all
measures in the APP Plus quality
measure set must be reported. As
detailed in Table 53, the current APP
quality measure set consists of six
measures: two administrative claims
measures, the CAHPS for MIPS survey,
and three measures that MIPS eligible
clinicians reporting the APP must
actively report to CMS via the Medicare
CQM (Shared Savings Program ACOs
only), eCQM, CQM, or Part B claims
collection types. MIPS eligible
clinicians, groups, or APM Entities
reporting the proposed APP Plus quality
measure set would report via the
available collection types: eight
measures for the CY 2025 performance
period/2027 MIPS payment year; nine
measures for the CY 2026 and 2027
performance periods/2028 and 2029
MIPS payment years; and eleven
measures for the CY 2028 performance
period/2030 MIPS payment period.
The quality performance category
burden for MIPS eligible clinicians who
elect to report the proposed APP Plus
quality measure set varies compared to
the current APP quality measure set,
traditional MIPs, and MVPs. We assume
MIPS eligible clinicians incur no burden
for reporting the two administrative
claims quality measures currently
required under the APP quality measure
set, as similar to cost measures, we
automatically calculate scores from
administrative claims reporting.
Additionally, burden estimates for the
CAHPS for MIPS registration and
patient reporting are provided in the
CAHPS for MIPS PRA package under
OMB control number 0938–1222 (CMS–
10450); we do not assume that MIPS
eligible clinicians incur additional
reporting burden for reporting this
measure under the current APP quality
measure set. Therefore, we assume that
MIPS eligible clinicians reporting the
proposed APP Plus quality measure set
would incur burden for actively
submitting their quality performance
category data via the available collection
types—eCQM, CQM/QCDR, and
Medicare Part B claims. We note, these
assumptions for actively submitting to
assess clinician reporting burden may
differ from MIPS scoring policy. This
active submission of quality
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performance data would include five of
the eight quality measures for the CY
2025 performance period/2027 MIPS
payment year, six of the nine quality
measures for the CY 2026 and 2027
performance periods/2028 and 2029
MIPS payment years, and eight of the
eleven measures for the CY 2028
performance period/2030 MIPS
payment year. Continuing this burden
comparison for MIPS eligible clinicians
reporting the proposed APP Plus quality
measure set for the CY 2025
performance period/2027 MIPS
payment year, clinicians would need to
actively submit quality performance
category data for one less quality
measure than clinicians participating in
traditional MIPS (six measures), two
more quality measures than clinicians
participating via the APP (three
measures), and one more quality
measure than clinicians participating
via MVPs (four measures). For the CY
2026 and 2027 performance periods/
2028 and 2029 MIPS payment years,
clinicians reporting the proposed APP
Plus quality measure set would need to
actively submit quality performance
category data for the same number of
quality measures as clinicians
participating in traditional MIPS (six
measures); they would need to report
three more quality measures than
clinicians participating via the APP
(three measures), and two more quality
measures than clinicians participating
via MVPs (four measures). Beginning in
the CY 2028 performance period/2030
MIPS payment year, clinicians reporting
the proposed APP Plus quality measure
set would need to actively submit
quality performance category data for
two more quality measures than
clinicians reporting via traditional MIPS
(six measures), five more quality
measures that clinicians participating
via the APP (three measures), and four
more measures than clinicians
participating via MVPs (four measures).
For this comparison of MIPS reporting
requirements, we assume that clinicians
reporting via traditional MIPS and
MVPs will report eCQM, CQM, and Part
B Claims measures, and will not elect to
report the CAHPS for MIPS survey. As
proposed in section IV.A.4.c.(2). of this
proposed rule, all Shared Savings
Program ACOs would be required to
report the APP Plus measure set for the
CY 2025 performance period/2027 MIPS
payment year. Per section 1899(e) 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
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PRA. As the APP Plus is a new measure
set, and optional, with exception to the
Shared Savings Program ACOs, we are
unable to estimate how many MIPS
eligible clinicians would submit quality
measures via the APP Plus at this time
via individual, group, or non-Shared
Savings Program ACO Entity reporting.
We will update these estimates as
additional data are available. We refer
readers to section VII.E.17.e.(2)(h). of
this proposed rule for additional
discussion.
For the Promoting Interoperability
performance category, group TINs may
submit data on behalf of eligible
clinicians in MIPS APMs, or eligible
clinicians in MIPS APMs may submit
data individually. Additionally, APM
Entities may report the Promoting
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Interoperability performance category at
the APM Entity level beginning with the
CY 2023 performance period/2025 MIPS
payment year (87 FR 70087 and 70088).
In the CY 2017 Quality Payment
Program final rule (81 FR 30132), we
codified at § 414.1380(b)(3)(i) that
individual MIPS eligible clinicians
participating in APMs (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. We also stated
that MIPS eligible clinicians
participating in an APM for a
performance period may receive an
improvement activity score higher than
50 percent (81 FR 30132). To provide
clarity for APM participants not scored
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62113
under the APP in the CY 2024 PFS final
rule (88 FR 79365 through 79367), we
revised § 414.1380(b)(3)(i) to state that a
MIPS eligible clinician participating in
an APM receives an improvement
activities performance category score of
at least 50 percent if the MIPS eligible
clinician reports a completed
improvement activity or submits data
for the quality and Promoting
Interoperability performance categories.
MIPS 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).
BILLING CODE P
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TABLE 80: Clinicians or Organizations Submitting MIPS Data on Behalf of Clinicians,
by Type of Data and Category of Clinician
Promoting Interoperability
Performance Category
Improvement Activities
Performance Category
Reweighting Applications for
extreme and uncontrollable
circumstances, significant
hardship, or other exceptions
MVP and Subgroup
Registration
Partial QP Election
Registration for the CARPS
for MIPS Survey
Virtual Group Registration
APM Performance Pathway
(APP)
Categor~ of Clinician
Individual clinician (MIPS eligible, voluntary, opt-in), group, virtual group,
subgroup, or APM Entity.
Subgroup reporting is only available for clinicians participating in MVP reporting.
Voluntary reporting and virtual group reporting are only available for clinicians
participating in traditional MIPS.
Opt-in reporting is only available for clinicians participating in traditional MIPS
and the APM Performance Pathway.
Individual clinician (MIPS eligible, voluntary, opt-in), group, virtual group,
subgroup, or APM Entity.
Each eligible clinician in an APM Entity could report data for the Promoting
Interoperability performance category at the individual level, or as part of their
group TIN, or under their APM Entity TIN. The burden estimates for this
proposed rule assume group TIN-level reporting.
Individual clinician (MIPS eligible, voluntary, opt-in), group, virtual group,
subgroup, or APM Entity.
For eligible clinicians in an APM Entity, the burden estimates for this proposed
rule assume individual or group TIN-level reporting.
Clinicians who submit an application may be eligible for a reweighting of the
approved performance category to zero percent under specific circumstances as
set forth in § 414.1380(c)(2), including, but not limited to, extreme and
uncontrollable circumstances, significant hardship, or another exception.
Certain types of MIPS eligible clinicians are automatically eligible reweighting
for the Promoting Interoperability performance category to zero percent as
described in§ 414.1380(c)(2)(i)(C).
An MVP participant, as described at§ 414.1305, electing to submit data for the
measures and activities in an MVP must register. Clinicians who choose to
participate as a subgroup for reporting an MVP must also register.
Eligible clinicians who attain Partial QP status and choose to participate in MIPS
must submit a partial OP election form.
Groups electing to use a CMS-approved survey vendor to administer the CAHPS
for MIPS Survey must register.
Virtual groups must register via email. Virtual group participation is limited to
MIPS eligible clinicians, specifically, solo practitioners who are MIPS eligible
and groups consisting of 10 eligible clinicians or fewer that have at least one
MIPS eligible clinician.
Clinicians in MIPS APMs electing the APP. The burden estimates for this
proposed rule assume that Shared Savings ACO APM Entities will submit data
through the APP via the APP Plus measure set beginning in CY 2025
performance period/2027 MIPS payment year, and non-Shared Savings Program
ACO APM Entities will participate through traditional MIPS, submitting as an
individual or group rather than as an APM Entity.
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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, CY 2023, and CY 2024 PFS
final rules (83 FR 59452, 84 FR 62568,
85 FR 84472, 86 FR 64996, 87 FR 70131,
and 88 FR 78818), and continued in this
proposed rule create some additional
data collection requirements not listed
in Table 80. These additional data
collections, some of which are currently
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approved by OMB under the control
number 0938–1314 (Quality Payment
Program/MIPS, CMS–10621) or pending
renewal under 0938–1222 (CAHPS for
MIPS, CMS–10450), are as follows:
Additional ICRs related to MIPS third
party intermediaries (see sections
V.B.8.c. and V.B.8.d. of this proposed
rule):
• Self-nomination of new QCDRs (81
FR 77507 and 77508, 82 FR 53906
through 53908, and 83 FR 59998
through 60000) (OMB 0938–1314).
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• Simplified self-nomination process
of returning QCDRs (88 FR 79426 and
79427) (OMB 0938–1314).
• Self-nomination of new qualified
registries (81 FR 77507 and 77508, 82
FR 53906 through 53908, and 83 FR
59997 and 59998) (OMB 0938–1314),
• Simplified self-nomination process
of returning qualified registries (88 FR
79429) (OMB 0938–1314).
• Third party intermediary plan
audits (87 FR 70140 through 70144)
(OMB 0938–1314).
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T~ pe of Data Submitted
Quality Performance Category
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• 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 and 84970).
Additional ICRs related to the data
submission and the quality performance
category (see section V.B.8.e. of this
proposed rule):
• CAHPS for MIPS Survey
completion by beneficiaries (81 FR
77509, 82 FR 53916 and 53917, and 83
FR 60008 and 60009) (OMB 0938–1222).
• Quality Payment Program Identity
Management Application Process (82 FR
53914 and 83 FR 60003 and 60004)
(OMB 0938–1314).
Additional ICRs related to the
Promoting Interoperability performance
category (see section V.B.8.g. of this
proposed rule):
• Reweighting Applications for MIPS
performance categories (82 FR 53918
and 83 FR 60011 and 60012) (OMB
0938–1314).
Additional ICRs related to call for
new MIPS measures and activities (see
sections V.B.8.i., V.B.8.f., and V.B.8.j. of
this proposed rule):
• Nomination of improvement
activities (82 FR 53922 and 83 FR 60017
and 60018) (OMB 0938–1314).
• Call for MIPS quality measures (83
FR 60010 and 60011) (OMB 0938–1314).
• Nomination of MVPs (85 FR 84990
through 84991) (OMB 0938–1314).
Additional ICRs related to MIPS (see
section V.B.8.n. of this proposed rule):
• Opt out of performance data display
on Compare Tools for voluntary
reporters under MIPS (82 FR 53924 and
53925 and 83 FR 60022) (OMB 0938–
1314).
Additional ICRs related to APMs (see
sections V.B.8.l. and V.B.8.m. of this
proposed):
• Partial QP Election (81 FR 77512
and 77513, 82 FR 53922 and 53923, and
83 FR 60018 through 60019) (OMB
0938–1314).
• Other Payer Advanced APM
determinations: Payer Initiated Process
(82 FR 53923 and 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 rulemaking is not proposing any
new or revised collection of information
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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)
In sections V.B.8.c.(2)., V.B.8.c.(3).,
V.B.8.c.(4)., and V.B.8.c.(5). of this
proposed rule, we identify proposed
adjustments to the estimated burden for
ICRs regarding third party
intermediaries that will be submitted to
OMB for review under control number
0938–1314 (CMS–10621), as
summarized in Tables 78 and 79. We
note that these proposed adjustments to
estimated burden are due to the
availability of updated data and related
assumptions as identified per ICR,
rather than proposed policies or statute
changes in section IV.A.4. of this
proposed rule.
(1) Background
Under MIPS, the quality, Promoting
Interoperability, and improvement
activities performance category data
may be submitted via relevant third
party intermediaries, such as QCDRs
and qualified registries. Data on the
CAHPS for MIPS Survey, which counts
as either one quality performance
category measure, or towards an
improvement activity, can be submitted
via CMS-approved survey vendors. We
refer readers to § 414.1400 for details on
third party intermediary requirements.
Entities seeking approval to submit data
on behalf of clinicians as a QCDR,
qualified registry, or survey vendor
must complete a self-nomination
process annually. The processes for selfnomination of entities seeking approval
as QCDRs and qualified registries are
similar with the exception that QCDRs
have the option to nominate QCDR
measures for CMS consideration for the
reporting of quality performance
category data. Therefore, the difference
between the QCDR and qualified
registry self-nomination is associated
with the preparation of QCDR measures
for CMS consideration. As established
in the CY 2024 PFS final rule (88 FR
79425), we continue to estimate burden
separately for the simplified and full
self-nominations of QCDRs and
qualified registries, to more accurately
capture the distinct number of estimated
respondents and burden per selfnomination for the different processes.
In the CY 2024 PFS final rule (88 FR
79390 and 79391), we eliminated the
category of health information
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technology (IT) vendors from MIPS
third party intermediaries beginning
with the CY 2025 performance period/
2027 MIPS payment period.
(2) QCDR Self-Nomination Applications
We refer readers to the CY 2017 and
CY 2018 Quality Payment Program final
rules (81 FR 77507 and 77508, and 82
FR 53906 through 53908, respectively),
and the CY 2019, CY 2020, CY 2021, CY
2022, CY 2023, and CY 2024 PFS final
rules (83 FR 59998 through 60000, 84
FR 63116 through 63121, 85 FR 84964
through 84969, 86 FR 65569 through
65573, 87 FR 70138 and 70139, and 88
FR 79426 through 79429 respectively)
for our previously finalized
requirements and estimated burden for
self-nomination of QCDRs and
nomination of QCDR measures.
We are proposing to adjust burden for
QCDR self-nomination applications
based on updated assumptions for the
number of applications and QCDR
measure submissions that we expect to
receive during the CY 2024 selfnomination period for the CY 2025
performance period/2027 MIPS
payment year. As discussed later in this
section, we are proposing to adjust our
estimates for: (1) the number of QCDRs
that will submit applications under the
simplified and full self-nomination
processes; (2) the number of QCDR
measures (existing or borrowed and new
measures) submitted by a QCDR; and (3)
the average time required for a QCDR to
submit the QCDR measure information.
(a) Simplified Self-Nomination Process
and Other Requirements
We estimate that 39 existing QCDRs
will submit applications under the
simplified self-nomination process for
the CY 2025 performance period/2027
MIPS payment year. We derive this
estimate from the number of
applications received during the CY
2023 QCDR self- nomination period for
the CY 2024 performance period/2026
MIPS payment year, while anticipating
that: (1) some QCDRs may face remedial
action or termination during the CY
2024 performance period/2026 MIPS
payment year, and (2) some
intermediaries may electively
discontinue participating as a QCDR.
This estimate is a decrease of 5
respondents from the currently
approved estimate of 44 for the QCDR
simplified self-nomination process (88
FR 79426 and 79427).
In line with these assumptions and
QCDR measure submission trends, we
estimate that simplified QCDR
applicants will propose 14 QCDR
measures, on average, for the CY 2025
performance period/2027 MIPS
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payment year, consisting of
approximately 3 new QCDR measures
and 11 existing or borrowed QCDR
measures per QCDR. This is an increase
of 1 new QCDR measure and 1 borrowed
QCDR measure per QCDR from the
currently approved aggregated estimate
of 12 QCDR measures in the CY 2024
PFS final rule (88 FR 79426). Due to this
change, we propose to adjust the
estimated weighted average time
required for each QCDR to submit a
QCDR measure from 0.75 hours to 0.82
hours [((3 new QCDR measures × 2 hr)
+ (11 existing or borrowed QCDR
measures × 0.5 hr)) ÷ total # of QCDR
measures (14)]. We are continuing our
currently approved estimated response
times to submit a new QCDR measure (2
hr/response) and an existing or
borrowed QCDR measure (0.5 hr/
response). We are also continuing our
currently approved response time of 0.5
hours required for existing QCDRs that
do not submit QCDR measures under
the simplified self-nomination process.
For existing QCDRs that submit QCDR
measures as part of their selfnomination application, we estimate
that it will take 11.98 hours [0.5 hr for
the simplified self-nomination process +
(14 QCDR measures × 0.82 hr/measure
for QCDR measure submission)] for a
QCDR to submit an application under
the simplified self-nomination process.
We note that this proposed change will
result in an increase of 2.48 hours (11.98
hr adjusted estimate ¥9.5 hr currently
approved estimate) for each applicant to
complete the simplified QCDR selfnomination process (88 FR 79426 and
79427).
From these assumptions, we estimate
the total annual burden associated with
a QCDR self-nominating to be
considered ‘‘qualified’’ to submit data
on behalf of MIPS eligible clinicians. As
shown in Table 81, 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 $106.54/hr. We
estimate the burden per application will
be $1,276.35 (11.98 hr × $106.54/hr). In
aggregate and inclusive of the 2.48 hr
adjustment for the CY 2025 performance
period/2027 MIPS payment year, we
estimate an annual burden of 467 hours
(39 applications × 11.98 hr/application)
at a cost of $49,778 (39 applications ×
$1,276.35/application) for the simplified
QCDR self-nomination process.
TABLE 81: Adjusted Burden for Simplified QCDR Self-Nomination and QCDR
Measure Submission
final rule (88 FR 79426 and 79427). In
aggregate, using our currently approved
estimates for responses and time per
response, the proposed decrease in the
number of simplified QCDR selfnomination applications and the
In Table 82, we illustrate the
proposed net change in estimated
burden for simplified QCDR selfnomination and QCDR measure
submission using the currently
approved burden in the CY 2024 PFS
increase in the estimated burden hours
per simplified QCDR self-nomination
will result in a total annual adjustment
of +49 hours at a cost of +$5,244 for the
CY 2025 performance period/2027 MIPS
payment year.
We estimate that 17 QCDRs will
submit applications under the full selfnomination process for the CY 2025
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performance period/2027 MIPS
payment year. We derive this estimate
from the number of applications
received during the CY 2023 QCDR selfnomination period for the CY 2024
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payment year, while anticipating that:
(1) some existing QCDRs may face
remedial action and would need to
complete the full self-nomination
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(b) Full QCDR Self-Nomination Process
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TABLE 82: Change in Estimated Burden for Simplified QCDR Self-Nomination and
QCDR Measure Submission
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
process for the CY 2025 performance
period/2027 MIPS payment year, and (2)
several new QCDR self-nominations.
This estimate is an increase of 5
respondents (17 revised¥12 active
applications) for the QCDR full selfnomination process (88 FR 79427).
As estimated for the QCDR simplified
self-nomination process in section
V.B.8.c.(2)(a). of this proposed rule, we
estimate that QCDR applicants
completing the full self-nomination
process will propose on average 14
QCDR measures for the CY 2025
performance period/2027 MIPS
payment year, consisting of
approximately 3 new QCDR measures
and 11 existing or borrowed QCDR
measures per QCDR. This is an increase
of 1 new QCDR measure and 1 borrowed
QCDR measure per QCDR from the
currently approved aggregated estimate
of 12 QCDR measures in the CY 2024
PFS final rule (88 FR 79427). Due to this
change, we also propose to adjust the
estimated weighted average time
required for each QCDR to submit a
QCDR measure from 0.75 hours (10
existing QCDR measures × 0.5 hr + 2
new QCDR measures × 2 hr) ÷ 12 total
QCDR measures) to 0.82 hours (11
existing QCDR measures × 0.5 hours +
3 new QCDR measures × 2 hours) ÷ 14
total QCDR measures). We are
continuing our currently approved time
of 2.5 hours required for new QCDRs
that do not submit QCDR measures
under the full self-nomination process,
and our estimated per response times
for a QCDR to submit a new QCDR
measure (2 hr/response) and an existing
or borrowed QCDR measure (0.5 hr/
response).
Due to the estimated (¥5 applications
= 44 active¥39 new estimate) increase
in the average number of existing or
borrowed QCDR measures (+1) and new
QCDR measures (+1) submitted with the
full self-nomination application, we
estimate that it will take 13.98 hours
[2.5 hr for the full self-nomination
process + (14 QCDR measures × 0.82 hr/
measure for QCDR measure
submission)] for a QCDR to submit an
application under the full selfnomination process. This proposed
62117
change will result in an overall increase
of 2.48 hours (13.98 hr revised¥11.5 hr
active) required for the full QCDR selfnomination application (88 FR 79428
and 79429).
From these updated 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 83, 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 $106.54/
hr. We estimate the burden per
application will be $1,489.43 (13.98 hr
× $106.54/hr). In aggregate, for the CY
2025 performance period/2027 MIPS
payment year, we estimate an annual
burden of 238 hours (17 applications ×
13.98 hr) at a cost of $25,320 (17
applications × $1,489.43/application)
for the full QCDR self-nomination
process.
TABLE 83: Estimated Burden for Full QCDR Self-Nomination and QCDR
Measure Submission
In Table 84, we use the currently
approved burden as the baseline for
calculating the proposed net change in
burden for the full QCDR selfnomination process (88 FR 79427). For
the CY 2025 performance period/2027
MIPS payment year, the proposed
adjustment in the number of applicants
and time per applicant results in a total
annual adjustment of +100 hours at a
cost of +$10,617 for the CY 2025
performance period/2027 MIPS
payment year.
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$25,320
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TABLE 84: Change in Estimated Burden for Full QCDR Self-Nomination and QCDR
Measure Submission
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(3) Qualified Registry Self-Nomination
Process and Other Requirements
We refer readers to the CY 2017 and
CY 2018 Quality Payment Program final
rules (81 FR 77507 and 77508, and 82
FR 53906 through 53908, respectively),
and the CY 2019, CY 2020, CY 2021, CY
2022, CY 2023, and CY 2024 PFS final
rules (83 FR 59997 and 59998, 84 FR
63114 through 63116, 85 FR 84968 and
84969, 86 FR 65573 through 65576, 87
FR 70139 and 70140, and 88 FR 79429
and 79430 respectively) for our
previously finalized requirements and
estimated burden for self-nomination of
qualified registries.
In the CY 2024 PFS final rule (88 FR
79390 through 79391), we established
the elimination of the health IT vendor
category amid MIPS third party
intermediary beginning with the CY
2025 performance period/2027 MIPS
payment year. We believe that many
third party intermediaries serve as both
health IT vendors and qualified
registries for the purposes of submitting
data for MIPS eligible clinicians. As
with our burden assumptions in the CY
2024 PFS final rule (88 FR 79425), we
are not proposing any adjustments to
the number of qualified registries that
will submit applications for the
qualified registry self-nomination
process during the CY 2025
performance period/2027 MIPS
payment year.
We are proposing to adjust burden for
qualified registry self-nomination
applications based on the number of
applications we expect to receive for the
CY 2025 performance period/2027 MIPS
payment year. We note these proposed
changes are not due to proposed
policies discussed in section IV.A. of
this proposed rule.
(a) Simplified Qualified Registry SelfNomination Process
For this proposed rule, we estimate
that 76 qualified registries will complete
the simplified self-nomination process
in CY 2025 performance period/2027
MIPS payment year. We derive this
estimate from the number of
applications received during the CY
2023 qualified registry self- nomination
period for the CY 2024 performance
period/2026 MIPS payment year, while
anticipating that: (1) some qualified
registries may face remedial action or
termination during the CY 2024
performance period/2026 MIPS
payment year, and (2) some
intermediaries may electively
discontinue participating as a qualified
registry. This estimate is a decrease of
eight applications from the currently
approved estimate of 84 in the CY 2024
PFS final rule (88 FR 79429). We note
that we are continuing the currently
approved time of 0.5 hours for the
simplified qualified registry selfnomination process.
Based on these assumptions, we
estimate the total annual burden
associated with a qualified registry selfnominating to be considered ‘‘qualified’’
to submit data on behalf of MIPS
eligible clinicians. In Table 85, we
assume that the staff involved in the
simplified qualified registry selfnomination process will continue to be
computer systems analysts or their
equivalent, who have an average
adjusted labor rate of $106.54/hr. We
estimate the burden per response will be
$53.27 (0.5 hr × $106.54/hr) for the
simplified self-nomination process. In
aggregate, we estimate that the annual
burden for the simplified qualified
registry self-nomination process will be
38 hours (76 applications × 0.5 hr) at a
cost of $4,049 (76 applications × $53.27/
application) for the CY 2025
performance period/2027 MIPS
payment year.
TABLE 85: Estimated Burden for Simplified Qualified Registry Self-Nomination
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2024 PFS final rule (88 FR 79429). In
aggregate, using our proposed
adjustment to the number of
applications results in a total annual
change of minus 4 hours (42 hr
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active¥38 hr revised) and minus $426
($4,475¥$4,049) for the CY 2025
performance period/2027 MIPS
payment year.
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In Table 86, we illustrate the
proposed net change in estimated
burden for the simplified qualified
registry self-nomination using the
currently approved burden in the CY
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62119
TABLE 86: Change in Estimated Burden for Simplified Qualified Registry SelfNomination
025 PFS Proposed Rule
FS Proposed Rule (e)
(b) Full Qualified Registry SelfNomination Process
We estimate that 30 qualified
registries will submit applications under
the full self-nomination process for the
CY 2025 performance period/2027 MIPS
payment year. We derive this estimate
from the number of applications
received during the CY 2023 qualified
registry self- nomination period for the
CY 2024 performance period/2026 MIPS
payment year, while anticipating: (1)
that some existing qualified registries
may face remedial action during the CY
2025 performance period/2026 MIPS
payment year and may need to submit
full self-nomination applications, and
(2) several new qualified registry
applicants. This is an increase of 3
respondents from the currently
approved estimate of 27 in the CY 2024
PFS final rule (88 FR 79430). We note
we are continuing our currently
approved per response time estimate of
2 hours for the full qualified registry
self-nomination process.
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 87, we assume the staff
involved in the qualified registry selfnomination process will continue to be
computer systems analysts or their
equivalent, who have an average labor
rate of $106.54/hr. We estimate the
burden per response will be $213.08 (2
hr × 106.54/hr) for the full qualified
registry self-nomination process. In
aggregate, for the CY 2025 performance
period/2027 MIPS payment year, we
estimate that the annual burden for the
full qualified registry self-nomination
process will be 60 hours (30
applications × 2 hr) at a cost of $6,392
(30 applications × $213.08/application).
TABLE 87: Estimated Burden for Full Qualified Registry Self-Nomination
$213.08/application) for the full
qualified registry self-nomination
process for the CY 2025 performance
period/2027 MIPS payment year.
EP31JY24.127
2024 PFS final rule (88 FR 79429). In
aggregate, the proposed adjustments
result in a total annual adjustment of +6
hours (+3 applications × 2 hr/response)
at a cost of +$639 (3 applications ×
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In Table 88, we illustrate the
proposed net change in estimated
burden for the full qualified registry
self-nomination process using the
currently approved burden in the CY
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TABLE 88: Change in Estimated Burden for Full Qualified Registry Self-Nomination
(a) Targeted Audits
In the CY 2022 PFS final rule (86 FR
65547 and 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, CY
2023 PFS, and CY 2024 PFS final rules
for the QCDRs (86 FR 65574, 87 FR
70141, and 88 FR 79431 and 79432
respectively) and qualified registries (86
FR 65571, 87 FR 70141, and 88 FR
79431 and 79432 respectively) that
would submit the results of targeted
audits, we estimate that 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 self-nomination
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
$106.54/hr.
Due to an increase in data issues
among third party intermediaries during
the CY 2023 performance period/2025
MIPS payment year, we estimate that 35
third party intermediaries will submit
targeted audits for the CY 2025
performance period/2027 MIPS
payment year (see Table 89). We
estimate that the cost for a QCDR or a
qualified registry to submit a targeted
audit will range from $532.70 (5 hr ×
$106.54/hr) to $1,065.40 (10 hr ×
$106.54/hr). In aggregate for the CY
2025 performance period/2027 MIPS
payment year, we estimate an annual
burden ranging from 175 hours (35
responses × 5 hr/audits × 5 hr/audit)
and $18,645 (35 targeted audits ×
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$532.70/audit) to 350 hours (35 audits ×
10 hr/audit) and $37,289 (35 targeted
audits × $1,065.40/audit) (see Table 90
for the cost per audit).
(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 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. In the CY 2020 PFS final
rule (82 FR 63074), we finalized
requirements for QCDRs to submit a
QCDR measure participation plan in
instances where a QCDR believes the
low-reported QCDR measure that did
not meet benchmarking thresholds is
still important and relevant to a
specialist’s practice. We refer readers to
§ 414.1400(b)(4)(iii)(B)(10) for additional
details on policies for QCDR measure
participation plans.
Consistent with our assumptions in
the CY 2024 PFS final rule (88 FR
79431), we estimate that it will take 2
hours for a QCDR or qualified registry
to submit a participation plan. We
assume the staff involved in submitting
the participation plans will continue to
be computer systems analysts or their
equivalent, who have an average labor
rate of $106.54/hr.
As shown in Table 89, following
additional review of the MIPS data
submission reports, we estimate that 28
third party intermediaries will submit
self-nomination or QCDR measure
participation plans for the CY 2025
performance period/2027 MIPS
payment year. This is a decrease of 36
participation plans from the currently
approved estimate of 64 (88 FR 79431).
Many QCDRs submitted a QCDR
measure participation plan in their self-
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nomination for CY 2024 performance
period/2026 MIPS payment year, and
therefore we anticipate limited QCDR
measure participation plan for QCDR
self-nominations for the CY 2025
performance period/2027 MIPS
payment year.
In Table 90, we estimate that the cost
for a QCDR or a qualified registry to
submit a participation plan is $213.08 (2
hr × $106.54/hr). In aggregate for the CY
2025 performance period/2027 MIPS
payment year, we estimate the total
impact associated with QCDRs and
qualified registries to submit
participation plans will be 56 hours (28
participation plans × 2 hr/plan) at a cost
of $5,966 ((28 participation plans ×
$213.08/plan) (see Table 90 for the cost
per audit).
(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).
We refer readers to § 414.1400(e)(1)(i)
for third party intermediary
requirements for submitting CAPs.
We have observed a decrease in the
number of CAPs required from third
party intermediaries due to noncompliance with MIPS program
requirements. Accordingly, we estimate
20 third party intermediaries will
submit CAPs for the CY 2025
performance period/2027 MIPS
payment year. This is a decrease of 4
respondents from the currently
approved estimate of 24 (88 FR 79431).
We are continuing 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 $106.54/hr. In Table 90, we
estimate that the cost for a QCDR or a
qualified registry to submit a CAP is
$319.62 (3 hr × $106.54/hr). In aggregate
for the CY 2025 performance period/
2027 MIPS payment year, we estimate
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(4) Third Party Intermediary Plan
Audits
The following proposed burden
adjustments are due to the availability
of updated data and assumptions, rather
than proposed policy changes.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
the total impact associated with QCDRs
and qualified registries to CAPs would
be 60 hours (20 CAPs × 3 hr/plan) at a
cost of $6,392 (20 CAPs × $319.62/plan).
(d) Transition Plans
We established a policy at
§ 414.1400(a)(3)(iv) that states a
condition of approval for the third party
intermediary is to agree that prior to
discontinuing services to any MIPS
eligible individual 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. In this proposed rule, we estimate
that we will receive 6 transition plans
for the CY 2025 performance period/
2027 MIPS payment year. This
adjustment would result in a decrease of
3 transition plans from the currently
approved estimate of 9 transition plans
(88 FR 79431). We continue to estimate
it will take 1 hour for a computer system
analyst or their equivalent at a labor rate
of $106.54/hr to develop a transition
plan on behalf of each QCDR or
qualified registry during the selfnomination period. However, we are
unable to estimate the burden for
implementing the actions in the
transition plan because the level of
62121
effort may vary for each QCDR or
qualified registry. In aggregate for the
CY 2025 performance period/2027 MIPS
payment year, we estimate the impact
associated with QCDRs and qualified
registries completing transition plans is
6 hours (6 transition plans × 1 hr/plan)
at a cost of $639 (6 transition plans ×
$106.54/plan).
(e) Estimated Burden for Third Party
Intermediary Plan Audits
In aggregate, as shown in Table 89, we
assume that 89 third party
intermediaries will submit plan audits
for the CY 2025 performance period/
2027 MIPS payment year (35 targeted
audits, 28 participation plans, 20 CAPs,
and 6 transition plans).
TABLE 89: Estimated Number of Respondents to Submit Plan Audits
Burden and Respondent Descriptions
# of Respondents
# of Targeted Audits (a)
# of Participation Plans (b)
# of Corrective Action Plans (CAPs) (c)
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analysts or their equivalent, who have
an average labor rate of $106.54/hr. For
the CY 2025 performance period/2027
MIPS payment year, in aggregate, the
proposed estimated annual burden for
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the submission of third party
intermediary plan audits will range
from 297 hours to 472 hours at a cost
ranging from $31,642 and $50,286.
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As shown in in Table 90, 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
35
28
20
62122
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TABLE 90: Estimated Burden for Third Party Intermediary Plan Audits
. .
Burden and Respondent Descnpt,ons
Simplified
p
rocess
5
# of Hours per Completion of Targeted Audit (a)
# of Hours per Submission of Participation Plan (c)
p
Full
rocess
10
2
2
3
3
$213.08
$213.08
$319.62
$319.62
$106.54
$106.54
•Total Annul/ti IIoursJor Sµblllission of 28 Participation. Plans (d) ·.· •
# of Hours per Submission CAP (e)
TotaLAnnu.al Hours. for Subndssion of:20 CAPs (f) . .• •
# of Hours per Submission of Transition Plan (g)
Cost Per Targeted Audit (Computer Systems Analyst's Labor Rate of$106.54/hr) U) =
a x $106.54/hr
Cost Per Participation Plan (Computer Systems Analyst's Labor Rate of$106.54/hr) (k)
= C X $106.54/hr
Cost per CAP (Computer Systems Analyst's Labor Rate of$106.54/hr)) (1) = (e) x
$106.54/hr
Cost per Transition Plan (Computer Systems Analyst's Labor Rate of $106.54/hr (m) =
x $106.54/hr
As shown in Table 91, for the CY
2025 performance period/2027 MIPS
payment year, the change in the number
of respondents for third party
intermediary plan audits results in an
adjustment of ¥57 hours at a cost of
¥$12,303 under the simplified selfnomination process and ¥27 hours at a
cost of ¥$2,878 under the full selfnomination process. We note for the
purposes of calculating estimated
change in burden in Tables 77 through
79 of this proposed rule, we use only
estimated burden for the plan audits
submitted under the full selfnomination process.
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–
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10450) if the policy proposal described
in section IV.A.4.j. of this proposed rule
is finalized in the CY 2025 PFS final
rule. We would plan to make the revised
files available for public review under
the standard non-rule PRA process
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which includes the publication of 60and 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.
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In section IV.A.4.j.(1)(b). of this
proposed rule, we are proposing under
the current application submission
requirement at § 414.1400(d)(2) that
beginning with the CY 2026
performance period/2028 MIPS
payment year, a survey vendor must
include on its application the range of
cost of its third party intermediary
services (cost estimates would vary
based on the level of services provided).
With respect to a third party
intermediary that is solely a CMSapproved survey vendor, the
publishable costs would be limited to
the cost of services related to the
CAHPS for MIPS survey. If this proposal
is finalized, we would update the
CAHPS for MIPS Survey Vendor
Participation Form. We would also
update the CAHPS for MIPS Survey
Minimum Business Requirements to
detail the required survey vendor cost
information. We refer readers to section
IV.A.4.j.(1). of this proposed rule for
additional detail.
We anticipate that the proposed fields
for cost information would request cost
information that is readily available to
survey vendors. Therefore, we are not
proposing any adjustments in burden
because we assume the additional cost
requirement would not add significant
burden to the currently approved 10
hours per application first established in
the CY 2018 Quality Payment Program
final rule (82 FR 30216). We also
assume this change would not affect
survey vendor participation. We note
that we proposed updates to our
estimated burden under control number
0938–1222 (CMS–10450) as discussed
in the CY 2024 PFS final rule (88 FR
79433 and 79434). The 60-day notice
appeared in the Federal Register on
October 17, 2023 (88 FR 71573), while
the 30-day notice appeared on January
16, 2024 (89 FR 2622). The status for
OMB’s approval of the changes can be
monitored at: https://www.reginfo.gov/
public/do/PRAOMBHistory?ombControl
Number=0938-1222. We are not
proposing any additional updates under
this control number due to policies
proposed in this rulemaking. We refer
readers to section VII.E.17.e(2)(a) of this
proposed rule for additional discussion.
The proposed change, if finalized,
would result in updates to the CAHPS
for MIPS Survey Vendor Participation
Form and the CAHPS for MIPS Survey
Minimum Business Requirements. The
instrument and requirements guide are
currently approved by OMB under
control number 0938–1222 (CMS–
10450). The CAHPS for MIPS Survey
Vendor Participation Form and the
CAHPS for MIPS Survey Minimum
Business Requirements guide reflecting
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these proposed changes will be updated
if the policy proposal is finalized in the
CY 2025 PFS final rule as a requirement
for CAHPS for MIPS survey vendors
beginning in the CY 2026 performance
period/2028 MIPS payment year. We
will make the updated files available for
public review through a stand-alone
non-rule Federal Register notice that is
expected to appear in the Federal
Register in CY 2025 performance
period/2027 MIPS payment period.
d. ICRs Regarding Open Authorization
(OAuth) Credentialing and Token
Request Process
This rulemaking is not proposing any
new or revised collection of information
requirements or burden related to the
OAuth credentialing and token request
process for the CY 2025 performance
period/2027 MIPS payment year. 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 burden for
the OAuth credentialing and token
request process under that control
number.
e. ICRs Regarding Quality Data
Submission (§§ 414.1318, 414.1325,
414.1335, and 414.1365)
(1) Background
We refer readers to the CY 2017 and
CY 2018 Quality Payment Program final
rules (81 FR 77502 and 77503 and 82 FR
53908 through 53912, respectively), the
CY 2019, CY 2020, CY 2021, CY 2022,
CY 2023, and CY 2024 PFS final rules
(83 FR 60000 through 60003, 84 FR
63121 through 63124, 85 FR 84970
through 84974, 86 FR 65576 through
65588, 87 FR 70145 through 70154, and
88 FR 79434 through 79442,
respectively) for our previously
finalized estimated burden associated
with data submission for the quality
performance category.
Under our current policies, two
groups of clinicians submit data for the
quality performance category 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.
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(2) Changes and Adjustments to Quality
Performance Category Respondents
To determine QPs that are excluded
from MIPS, we used the Advanced APM
payment and patient percentages from
the APM Participant List for the final
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 2025 performance period/
2027 MIPS payment year. Due to data
limitations, we could not identify
specific clinicians who have not yet
enrolled in Advanced APMs, but who
may become QPs in the future for the
CY 2025 performance period/2027 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 this proposed rule, we use
submissions data from the CY 2022
performance period/2024 MIPS
payment year to estimate the number of
respondents that will submit data for
the CY 2025 performance period/2027
MIPS payment year. We have adjusted
the estimated number of respondents
that will submit data for the CY 2025
performance period/2027 MIPS
payment year from the currently
approved estimates, as our burden
estimates for the CY 2024 PFS final rule
(88 FR 79434) did not incorporate all
data updates in the CY 2024 PFS final
rule regulatory impact analysis model
(88 FR 79503 through 79505) due to the
timing of data availability. These
estimates in this proposed rule reflect
updated performance category
submissions for the CY 2022
performance period/2024 MIPS
payment year. We refer readers to
sections V.B.8.e., V.B.8.g.(3)., and
V.B.8.h. of this proposed rule for
additional details per performance
category and collection type.
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
quality reporting for ACO APM entities,
consistent with assumptions used in the
CY 2021, CY 2022, CY 2023, and CY
2024 PFS final rules (85 FR 84972, 86
FR 65567, 87 FR 70145, and 88 FR
79434, respectively), 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.8.a.(4). of this proposed
rule, we assume non-Shared Savings
Program ACO APM Entities will
participate through traditional MIPS or
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MVPs and submit as an individual or
group rather than as an entity. To
estimate who will be a MIPS APM
participant in the CY 2025 performance
period/2027 MIPS payment year, we
used the Advanced APM payment and
patient percentages from the APM
Participant List for the final snapshot
date for the 2022 QP performance
period. We elected to use this data
source because the overlap with the data
submissions for the CY 2022
performance period/2024 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 2022 performance period/
2024 MIPS payment year.
Our burden estimates for the quality
performance category do not include the
burden for the quality data that Shared
Savings Program 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.788
For the CY 2025 performance period/
2027 MIPS payment year, respondents
would 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. We
do not estimate burden for
administrative claims quality measures;
similar to cost measures, we
automatically calculate scores for
individuals, groups, virtual groups, or
APM Entities that meet requirements to
be scored on individual measures due to
their administrative claims reporting.
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
788 Our estimates do reflect the burden on MIPS
APM participants of submitting Promoting
Interoperability or improvement activities
performance category data, which is outside the
requirements of their APMs.
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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. In the CY 2019 PFS final
rule (83 FR 59752), we finalized
proposals to limit the Medicare Part B
claims collection type to small practices
beginning with the CY 2019
performance period/2021 MIPS
payment year and to allow clinicians in
small practices to report Medicare Part
B claims as a group or as individuals.
Because MIPS eligible clinicians may
submit data for multiple collection
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 2022
performance period/2024 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.
We are not proposing changes to the
quality performance category
submission burden due to the proposals
discussed in section IV.A. of this
proposed rule. We discuss below in this
section these proposed policies and our
reasons for not changing the currently
approved burden for the relevant ICRs.
For the quality performance category,
we are proposing to adopt minimum
criteria for a qualifying data submission
for a MIPS performance period.
Specifically, we are proposing to specify
what we consider to be a data
submission at § 414.1325(a)(1)(i) to state
that, for the quality performance
category, a data submission must
include numerator and denominator
data for at least one MIPS quality
measure from the final list of MIPS
quality measures. Additionally, we are
proposing to codify our existing policies
governing our treatment of multiple data
submissions received for the quality
performance category at § 414.1325(f)(1).
We refer readers to sections
IV.A.4.d.(2)(b) and IV.A.4.d.(3)(b) for
details. These proposals, if finalized,
would not affect the requirements for
MIPS eligible clinicians and groups that
submit data for the quality performance
category. We assume these proposals, if
finalized, would not affect the number
of quality submissions, as the intent is
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to eliminate certain issues with the
scoring of an unintended data
submission affecting payment
adjustments for individual MIPS eligible
clinicians, groups, virtual groups,
subgroups, and APM Entities. Therefore,
we are not proposing any adjustments to
our currently approved estimated
burden for this ICR due to these policy
proposals.
As described in the CY 2017 Quality
Payment Program final rule (81 FR
77125 and 77126), 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. 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 maintained the data
completeness criteria threshold of at
least 75 percent for the CY 2026
performance period/2028 MIPS
payment year (88 FR 79334 through
79337). In section IV.A.4.e.(1)(c)(i). of
this proposed rule, we are proposing to
maintain the data completeness criteria
threshold of at least 75 percent for the
CY 2027 and CY 2028 performance
periods/2029 and 2030 MIPS payment
years. As this data completeness
threshold proposal is consistent with
the existing data completeness criteria,
this proposal will not affect burden for
the applicable interested parties. We
refer readers to section IV.A.4.e.(1)(c)(i).
of this proposed rule for additional
information on this proposal.
In this proposed rule, we are not
proposing any new or revised collection
of information requirements or burden
related to the submission of Medicare
Part B claims data, QCDR and MIPS
CQMs, and eCQMs for the quality
performance category. Several factors
drive the proposed changes and
adjustments for the number of clinicians
submitting quality data for MIPS using
each collection type. First, we
incorporated the updated submission
data available for the CY 2022
performance period/2024 MIPS
payment year as discussed in section
V.B.8.e.(7)(a). of this proposed rule.
Second, our updated estimates for MVP
participation impact the number of
estimated clinicians submitting quality
data using each collection type. In
section V.B.8.e.(7)(a) of this rulemaking,
we propose to adjust our estimates for
the number of participants in previously
finalized MVPs, due to the availability
of updated data. We then propose to
update this estimate to account for
increased MVP participation due to the
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proposed addition of six new MVPs.
With this approach, any proposed
adjustments to increase the number of
MVP participants will reduce the
number of estimated submissions for
each quality performance category
collection type via traditional MIPS.
Similarly, any proposed decreases to the
number of MVP participants will
increase the number of estimated
submissions for each quality
performance category collection type via
traditional MIPS. We refer readers to
sections V.B.8.e.(4)., V.B.8.e.(5)., and
V.B.8.e.(6). of this proposed rule for
estimated burden on each quality
performance category collection type.
Table 92 uses similar methods to
estimate the number of MIPS eligible
clinicians that will submit data as
individual clinicians via each collection
type in the CY 2025 performance
period/2027 MIPS payment year. For
the CY 2025 performance period/2027
MIPS payment year, we estimate that
approximately 13,522 clinicians will
submit data as individuals using the
Medicare Part B claims collection type;
approximately 12,056 clinicians will
submit data as individuals using MIPS
CQM and QCDR collection type; and
approximately 23,600 clinicians will
submit data as individuals using eCQMs
collection type. Based on the
62125
availability of updated data for the CY
2022 performance period/2024 MIPS
payment year and updated assumptions
for MVP reporting as described in
section V.B.8.e.(7)(a). of this proposed
rule, these are decreases of 1,216 and
1,657 respondents from the currently
approved estimates of 13,413 and
22,897 for the Medicare Part B claims
and eCQM collection types, respectively
and an increase of 168 respondents for
MIPS CQM and QCDR collection type
from the currently approved estimate of
10,682.
TABLE 92: Estimated Number of Clinicians Submitting Quality Performance Category
Data as Individuals by Collection Type
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that will submit quality data on behalf
of clinicians for each collection type in
the CY 2025 performance periods/2027
MIPS payment year. We assume
clinicians who submitted quality data as
groups in the CY 2022 performance
period/2024 MIPS payment year will
continue to submit data for the quality
performance category either as groups,
or virtual groups for the same collection
types for the CY 2025 performance
period/2027 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
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CMS Web Interface collection type for
the CY 2022 performance period/2024
MIPS payment year.
As shown in Table 93, for the CY
2025 performance period/2027 MIPS
payment year, we estimate that 6,158
groups and virtual groups will submit
data for the MIPS CQM and QCDR
collection type and 5,939 groups and
virtual groups will submit for the eCQM
collection type. These are increases of
208 and 122 respondents from the
currently approved estimates of 5,950,
and 5,817 for the groups and virtual
groups that will submit data using MIPS
CQM and QCDR, and eCQM collection
types, respectively.
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Consistent with the policy finalized in
the CY 2018 Quality Payment Program
final rule, we established 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 and 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 92 are not mutually
exclusive.
Table 93 provides our estimates for
the number of groups or virtual groups
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TABLE 93: Estimated Number of Groups and Virtual Groups Submitting Quality
Performance Category Data by Collection Type
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
details on MVP quality reporting
requirements (86 FR 65411 and 65412).
In terms of the quality measures
available for clinicians and groups to
report for the CY 2025 performance
period/2027 MIPS payment year, we are
proposing a measure set of 196 quality
measures. The new MIPS quality
measures proposed for inclusion in
MIPS for the CY 2025 performance
period/2027 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 94,
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 of this
proposed rule for additional
information.
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 intermediary. As such, we
separately estimate the burden for
clinicians, groups, and third party
intermediaries 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 tax identification
numbers (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
TABLE 94: Summary of Quality Measure Inventory Proposed for the CY 2025
Performance Period
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*A measure may be specified under multiple collection types but is only counted once in the total.
**Note that one new measure and one measure removal included above were finalized in the CY 2024 PFS final
rule with a I-year delay to the CY 2025 performance period/2027 MIPS payment year.
***Three of the 196 quality measures are only available in MVPs.
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For the CY 2025 performance period/
2027 MIPS payment year, we are
proposing 196 measures, a net decrease
of 2 quality measures compared to the
currently approved estimate of 198
measures. Specifically, as discussed in
section IV.A.4.e.(1)(d). of this
rulemaking, we are proposing to add 9
new MIPS quality measures, remove 11
MIPS quality measures, and make
substantive updates to 66 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 in
traditional MIPS reporting or submit
quality data for 4 measures in an MVP.
(3) Quality Payment Program Identity
Management Application Process
This rulemaking does not propose any
new or revised collection of information
requirements or burden related to the
identity management application
process. We are adjusting our currently
approved estimates based on updated
data and assumptions. The proposed
changes will be submitted to OMB for
review under control number 0938–
1314 (CMS–10621).
In the CY 2023 and CY 2024 PFS final
rules (87 FR 70148 and 88 FR 79437),
we estimated the number of eligible
clinicians, groups, or third party
intermediaries that register for new
accounts by applying a rolling average
of the number of respondents registering
for new accounts. The Quality Payment
Program requires users to utilize HCQIS
Access Roles and Profiles (HARP), a
secure identity management portal, to
log into the Quality Payment Program
portal. To assess the incremental change
for new Quality Payment Program
Identity Management application
registrations, we will assess the number
of unique TINs associated with new
Quality Payment Program user accounts
62127
that signed into the Quality Payment
Program portal for the first time in a
given year. Based on this approach and
new data available from March 2022 to
February 2023, we propose to adjust our
estimates from 6,500 to 6,237 for the
number of unique TINs accessing the
Quality Payment Program portal for the
first time in the CY 2025 performance
period/2027 MIPS payment year. This
proposed adjustment will result in a
decrease of 263 registrations. We do not
propose to adjust the currently
approved estimated time of 1 hour per
response to obtain a new account. As
shown in Table 95, it will take 1 hour
at $106.54/hr for a computer systems
analyst (or their equivalent) to obtain a
HARP account, required to access the
Quality Payment Program portal. In
aggregate we estimate an annual burden
of 6,237 hours (6,237 registrations × 1
hr/registration) at a cost of $664,490
(6,237 registrations × $106.54/
registrations).
TABLE 95: Estimated Burden for Quality Payment Program Identity Management
Application Process
In Table 96, we illustrate the
proposed net change in estimated
burden for the Quality Payment Program
Identity Management Application
Process using the currently approved
burden in the CY 2023 PFS final rule
(87 FR 70148 and 70149). In aggregate,
using the currently approved per
response time estimate, the proposed
decrease of respondents results in a total
annual adjustment of ¥263 hours
(¥263 responses × 1 hr/response) at a
cost of ¥$28,020 (¥263 responses ×
$106.54/response) for the CY 2025
performance period/2027 MIPS
payment year.
TABLE 96: Change in Estimated Burden for Quality Payment Program Identity
Management Application Process
Burden anti Respondent Descriptions
Burden Estimate
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6,500
6,237
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Total CurrentI A roved Annual Time hr a
Total Annual Time (hr) for Respondents in CY 2025 PFS Proposed
Rule b See Table 95, row c
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(4) Quality Data Submission by
Clinicians: Medicare Part B ClaimsBased Collection Type
lotter on DSK11XQN23PROD with PROPOSALS2
The following proposed changes will
be submitted to OMB for review under
control number 0938–1314 (CMS–
10621). In this section of this proposed
rule, we propose updates to the
estimated burden for the Quality Data
Submission by Individuals and Groups
Using Medicare Part B Claims-Based
Collection Type that will be submitted
to OMB for review under control
number 0938–1314 (CMS–10621). As
noted in Table 79, the proposed change
in burden reflects adjustments for
updated data and assumptions, and as
well as the proposal for additional
MVPs as outlined in section V.B.8.e.(4).
of this proposed rule. In Table 95, we
identify the changes in burden to this
ICR due to the proposed policies.
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, CY 2023,
and CY 2024 PFS final rules (83 FR
60004 and 60005, 84 FR 63124 through
63126, 85 FR 84975 and 84976, 86 FR
65582 through 65584, 87 FR 70149
through 70151, and 88 FR 79437
through 79439 respectively) for our
previously finalized requirements and
burden for quality data submission via
the Medicare Part B claims collection
type.
In this proposed rule, we are not
proposing any new or revised collection
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of information requirements related to
the submission of Medicare Part B
claims data for the quality performance
category. We refer readers to section
V.B.8.e.(2). of this proposed rule for the
factors affecting the proposed changes
and adjustments for each quality
performance collection type. We refer
readers to Table 92 of this section for
the estimated change in associated
burden for quality data submissions
using Medicare Part B claims data
related to MVP and subgroup reporting
in CY 2025 performance period/2027
MIPS payment year.
As noted in Table 92, based on
updated data available for the CY 2022
performance period/2024 MIPS
payment year and updated MVP
reporting assumptions, we estimate that
12,197 individual clinicians will collect
and submit quality data via the
Medicare Part B claims collection type,
a decrease of 1,216 from the currently
approved estimate of 13,413 (88 FR
79437 and 79438).
In Table 97, consistent with our
currently approved per response time
figures and using the updated wage
rates in Table 75 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 $15.98 (0.15 hr
× $106.54) for a computer systems
analyst to 7.2 hours at a cost of $767.09
(7.2 hr × $106.54/hr). The burden
estimate also accounts for the effort to
become familiar with MIPS quality
measure specifications.
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Consistent with our currently
approved per response time estimates
and using the updated wage rates in
Table 75 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 $129.28/hr, 1 hour for a
computer systems analyst at $106.54/hr,
1 hour for a Licensed Practical Nurse
(LPN) at $58.46/hr, 1 hour for a billing
and posting clerk at $45.32/hr, and 1
hour for a physician at $291.64/hr.
In Table 97, considering both data
submission and start-up requirements
for our adjusted number of clinicians,
the estimated time (per clinician using
the Medicare Part B claims collection
type) 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 estimated total annual time for the
CY 2025 performance period/2027 MIPS
payment year ranges from 87,209 hours
(7.15 hr/response × 12,197 responses) to
173,197 hours (14.2 hr/response ×
12,197 responses). The total annual cost
for the CY 2025 performance period/
2027 MIPS payment year ranges from a
minimum of $11,047,799 (12,197
responses × $905.78/response) to a
maximum of $20,209,087 (12,197
responses × $1,656.89/response). For
purposes of calculating total burden
associated with this proposed rule as
shown in Tables 77 through 79, only the
maximum burden is used.
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TABLE 97: Estimated Burden for Quality Performance Category: Clinicians Using the
Medicare Part B Claims Collection Type
Hours Per Computer Systems Analyst to Submit
ualit Data b
# of Hours Medical and Health Services Manager
Review Measure S ecifications c
# of Hours Computer Systems Analyst Review
Measure S ecifications d
# of Hours LPN Review Measure Specifications
e
# of Hours Billing Clerk Review Measure
0.15
7.2
3
3
3
7.15
8.05
14.2
$15.98
$111.87
$767.09
$387.84
$387.84
$387.84
$106.54
$106.54
$106.54
$58.46
$58.46
$58.46
$45.32
$45.32
$45.32
$291.64
$291.64
$291.64
$905.78
$1,001.67
$1,656.89
s
# of Hours Physician Review Measure
s
Annual Hours per Clinician (h) = (b) + (c) + (d) +
'"
Cost to Submit Quality Data (Computer Systems
Analyst's Labor Rate of$106.54/hr at varying
times
Cost to Review Measure Specifications (Medical
and Health Services Manager's Labor Rate of
$129.28/hrfor3 hr k
Cost to Review Measure Specifications
(Computer Systems Analyst's Labor Rate of
$106.54/hr for 1 hr 1
Cost to Review Measure Specifications (LPN's
Labor Rate of$58.46/hr for 1 hr m
Cost to Review Measure Specifications (Billing
Clerk's Labor Rate of$45.32/hr n
Cost to Review Measure Specifications
Ph sician's Labor Rate of$291.64/hr o
Total Annual Cost Per Clinician (p) = (j) + (k) +
l+m+n+o
:,':Tq;tat\l)i'huit'Vf., ~$tr,,·•
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aggregate, using our currently approved
per response time estimates, the
decrease in number of responses from
13,413 to 12,197 (¥1,216) (Table 92)
will result in a total maximum
adjustment of ¥17,268 hours at a cost
of ¥$2,014,779 for the CY 2025
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performance period/2027 MIPS
payment year. For purposes of
calculating total burden associated with
this proposed rule as shown in Tables
77 through 79, only the maximum
burden is used.
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In Table 98, we illustrate the net
change in estimated burden for quality
data submissions from clinicians using
the Medicare Part B Claims-based
collection type using the currently
approved burden in the CY 2024 PFS
final rule (88 FR 79438 and 79439). In
62130
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
TABLE 98: Change in Estimated Burden for Quality Performance Category: Clinicians
Using the Medicare Part B Claims Collection Type
Burden and Respondent Descdptions
Burden Estimate
Total Currently Approved Annual Hours (a)
190,465
Total Annual Hours for Respondents in CY 2025 PFS Proposed Rule (b) (see Table 97,
(5) Quality Data Submission by
Individuals and Groups Using MIPS
CQM and QCDR Collection Types
In this section, we identify proposed
updates to the estimated burden for the
Quality Data Submission by Individuals
and Groups Using MIPS CQM and
QCDR Collection Types ICR that will be
submitted to OMB for review under
control number 0938–1314 (CMS–
10621). As noted in Table 79, the
proposed change in burden reflects
adjustments for updated data and
assumptions, and as well as the
proposal for additional MVPs as
outlined in section V.B.8.e.(4). of this
proposed rule. In Table 146 (section
VII.E.17.e.(1).), we identify the changes
in burden to this ICR due to the
proposed policies.
We refer readers to the CY 2017 and
CY 2018 Quality Payment Program final
rules (81 FR 77504 and 77505 and 82 FR
53912 and 53914, respectively), the CY
2019, CY 2020, CY 2021, CY 2022, CY
2023, and CY 2024 PFS final rules (83
FR 60005 and 60006, 84 FR 63127 and
63128, 85 FR 84977 through 84979, 86
FR 65584 through 65586, and 87 FR
70151 through 70153, and 88 FR 79439
through 79441, 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 105 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 2025 performance
period/2027 MIPS payment year. We
refer readers to section V.B.8.e.(2). of
this proposed rule for the factors
affecting the proposed changes and
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adjustments for each quality
performance collection type.
As noted in Tables 92 and 93, based
on updated data available from the CY
2022 performance period/2024 MIPS
payment year and updated MVP
reporting assumptions, for the CY 2025
performance period/2027 MIPS
payment year, we estimate that 17,008
clinicians (10,850 individuals and 6,158
groups and virtual groups) will submit
quality data as individuals or groups
using MIPS CQM or QCDR collection
types. This is an increase of 376
clinicians from the currently approved
estimate of 16,632 clinicians provided
in the CY 2024 PFS final rule (88 FR
79439 through 79441). 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 collection
types together. 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
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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 $1,088.98 per
response. This consists of 3 hours at
$106.54/hr for a computer systems
analyst (or their equivalent) to submit
quality data along with 2 hours at
$129.28/hr for a medical and health
services manager, 1 hour at $106.54/hr
for a computer systems analyst, 1 hour
at $58.46/hr for a LPN, 1 hour at $45.32/
hr for a billing clerk, and 1 hour at
$291.64/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 $106.54/hr for a computer systems
analyst at a cost of $8.84 (0.083 hr ×
$106.54/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
$1,088.98/response [(3 hr × $106.54/hr)
+ (2 hr × $129.28/hr) + (1 hr × $106.54/
hr) + (1 hr × $58.46/hr) + (1 hr × $45.32/
hr) + (1 hr × $291.64/hr) + (0.083 hr ×
$106.54/hr)].
In Table 99, for the CY 2025
performance period/2027 MIPS
payment year, in aggregate, we estimate
a burden of 154,484 hours (9.083 hr/
response × 17,008 responses) at a cost of
$18,521,372 (17,008 responses ×
$1,088.98/response).
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Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62131
TABLE 99: Estimated Burden for Quality Performance Category: Clinicians
(Participating Individually or as Part of a Group) Using the MIPS CQM and QCDR
Collection Type
# of Hours per Medical and Health Services Manager to Review Measure Specifications
2
# of Hours for Com uter S stems Anal
# of Hours Per Respondent to Authorize Qualified Registry to Report on Respondent's
Behalf •
0.083
9.083
Cost Per Respondent to Submit Quality Data (at Computer Systems Analyst's Labor
Rate of $106.54/hr m = $106.54/hr x d
Cost to Review Measure Specifications (at Medical and Health Services Manager's
Labor Rate of$129.28/hr n = $129.28/hr x e
Cost per Computer System's Analyst Review of Measure Specifications (at Computer
S stems Anal st's Labor Rate of $106.54/hr o = $106.54/hr x
Cost per LPN to Review Measure Specifications (at LPN's Labor Rate of$58.46/hr) (p)
= $58.46/hr x
Cost per Billing Clerk to Review Measure Specifications at Clerk's Labor Rate of
$45.32/hr
= $45.32/hr x h
Cost for Physician to Review Measure Specifications (at Physician's Labor Rate of
$291.64/hr r = $291.64/hf X i
Cost for Respondent to Authorize Qualified Registry/QCDR to Report on Respondent's
Behalf
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burden in the CY 2024 PFS final rule
(88 FR 79439 through 79441). In
aggregate, using the unchanged
currently approved time per response
estimate, the increase of 376
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$258.56
$106.54
$58.46
$45.32
$291.64
$8.84
respondents from 16,632 to 17,008 for
the CY 2025 performance period/2027
MIPS payment year results in an
increase of 3,416 hours at a cost of
+$409,457.
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lotter on DSK11XQN23PROD with PROPOSALS2
In Table 100, 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
$319.62
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TABLE 100: Change in Estimated Burden for Quality Performance Category: Clinicians
(Participating Individually or as Part of a Group) Using the MIPS CQM and QCDR
Collection Type
. .
Bur d en an d R espon d ent Descnptmns
Total Current] A roved Annual Hours a
Total Annual Hours for Respondents in CY 2025 PFS Proposed Rule (b) (see Table 99,
row I
Total Annual Cost for Respondents in CY 2025 PFS Proposed Rule (e) (see Table 99,
row (u))
lotter on DSK11XQN23PROD with PROPOSALS2
(6) Quality Data Submission by
Clinicians and Groups: eCQM
Collection Type
In this section, we identify proposed
updates to the estimated burden for the
Quality Data Submission by Individuals
and Groups Using eCQM Collection
Type ICR that will be submitted to OMB
for review under control number 0938–
1314 (CMS–10621). As noted in Table
79, this proposed change in burden
reflects adjustments for updated data
and assumptions, and as well as the
proposal for additional MVPs as
outlined in section V.B.8.e.(4). of this
proposed rule. In Table 146 (section
VII.E.17.e.(1).of this proposed rule), we
identify the changes in burden to this
ICR due to the proposed policies.
We refer readers to the CY 2017 and
CY 2018 Quality Payment Program final
rules (81 FR 77505 and 77506 and 82 FR
53914 and 53915), CY 2019, CY 2020,
CY 2021, the CY 2022 PFS, the CY 2023,
and the CY 2024 PFS final rule (83 FR
60006 and 60007, 84 FR 63128 through
63130, 85 FR 84979 and 84980, 86 FR
65586 through 65588, 87 FR 70153 and
70154, and 88 FR 79441 through 79443
respectively) 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 2025
performance period/2027 MIPS
payment year, we refer readers to Table
105. We refer readers to section
V.B.8.e.(2). of this proposed rule for the
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factors affecting the proposed changes
and adjustments for each quality
performance collection type.
As noted in Tables 92 and 93, based
on updated data available from the CY
2022 performance period/2024 MIPS
payment year and updated MVP
reporting assumptions, we assume that
27,179 clinicians (21,240 individual
clinicians and 5,939 groups and virtual
groups) will submit quality data using
the eCQM collection type for the CY
2025 performance period/2027 MIPS
payment year. This is a decrease of
1,535 clinicians from the currently
approved estimate of 28,714 clinicians
in the CY 2024 PFS final rule (88 FR
78818)). 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 electronic health record
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 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
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$18,111,915
$18,521,372
and groups who submit their data
directly to us from their CEHRT and
clinicians and groups who use a QCDR
or qualified registry 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
note that the CY 2024 PFS final rule
eliminated the category of health IT
vendors for the Quality Payment
Program beginning in the CY 2025
performance period/2027 MIPS
payment period (88 FR 79390 and
79391).
We estimate that it will take no more
than 2 hours at $106.54/hr for a
computer systems analyst or their
equivalent to submit the 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 $129.28/hr for a medical and
health services manager, 1 hour at
$291.64/hr for a physician, 1 hour at
$106.54/hr for a computer systems
analyst, 1 hour at $58.46/hr for an LPN,
and 1 hour at $45.32/hr for a billing
clerk. Overall, we estimate a cost of
$973.60/response [(2 hr × $106.54/hr) +
(2 hr × $129.28/hr) + (1 hr × $106.54/
hr) + (1 hr × $58.46/hr) + (1 hr × $45.32/
hr) + (1 hr × $4291.64/hr)].
In Table 101, for the CY 2025
performance period/2027 MIPS
payment year, in aggregate, we estimate
a burden of 217,432 hours (8 hr × 27,179
responses) at a cost of $26,461,474
(27,179 responses × $973.60/response).
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Burden
E t'
t
s 1ma e
151,068
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Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62133
TABLE 101: Estimated Burden for Quality Performance Category: Clinicians (Submitting
Individually or as Part of a Group) Using the eCQM Collection Type
# of Hours Per Medical and Health Services Manager to Review Measure Specifications
# of Hours Per Billin Clerk to Review Mea
# of Hours Per Ph sic
Annual Hours Per Res ondent • = d + e +
l1lijt~l;~iiju3~::Q~'.u~F • ·. >,:.¥; i
Cost Per Respondent to Submit Quality Data (at Computer Systems Analyst's Labor Rate
of $106.54/hr) I = $106.54/hr x d)
Cost to Review Measure Specifications (at Medical and Health Services Manager's Labor
Rate of $129 .28/hr m = $129 .28/hr x e
Cost to Review Measure Specifications (at Computer System's Analyst's Labor Rate of
$106.54/hr) (n) = $106.54/hr x t)
Cost to Review Measure Specifications (at LPN's Labor Rate of$58.46/hr) (o) = $58.46/hr
$213.08
$258.56
$106.54
$58.46
X
Cost to Review Measure Specifications (at Clerk's Labor Rate of$45.32/hr) (p) =
$45.32/hr) x (h)
Cost to Review Measure Specifications (at Physician's Labor Rate of$29l.64/hr) (q) =
$291.64/hr X i
In Table 102, 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 2024 PFS
final rule (88 FR 79441 and 79442). In
aggregate, using our currently approved
time per response burden estimate, the
decrease of 1,535 respondents from
28,714 to 27,179 for the CY 2025
performance period/2027 MIPS
payment year results in a decrease of
$45.32
$291.64
12,280 hours (1,535 responses × 8 hr/
response) at a cost of ¥$1,494,476
(¥1,535 response) at a cost of
¥$1,494,476 (¥1,535 responses ×
$973.60/response).
Bun.fen
E .
t
st1ma e
Total Current) A roved Annual Hours a
Total Annual Hours for respondents in CY 2025 PFS Proposed Rule (b) (see Table IO 1,
229,712
217,432
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. .
Burden and Respondent Descnptions
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TABLE 102: Change in Estimated Burden for Quality Performance Category: Clinicians
(Participating Individually or as Part of a Group) Using the eCQM Collection Type
62134
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
(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).
lotter on DSK11XQN23PROD with PROPOSALS2
(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,
CY 2023, and CY 2024 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
2024 performance period/2026 MIPS
payment year (86 FR 65590 through
65592, 87 FR 70155, and 88 FR 79443).
As discussed in section II.G.2. of this
proposed rule, we are proposing to
make payment for advanced primary
care management(APCM) services
furnished by a physician or other
qualified health care professional who is
responsible for all primary care (for
example, physicians and non-physician
practitioners, including nurse
practitioners, physician assistants,
certified nurse-midwives and clinical
nurse specialists), and serve as the
continuing focal point for all needed
health care services during a calendar
month. This proposed payment would
incorporate several specific, existing
care management and communication
technology-based services into a bundle
and require reporting the Value in
Primary Care MVP by clinicians billing
for APCM services beginning in the CY
2025 performance period/2027 MIPS
payment year. We are proposing that
billing practitioners who are not MIPS
eligible clinicians (as defined at
§ 414.1305) would not be required to
report the MVP in order to furnish and
bill for APCM services. Based on our
approach for estimating MVP as a
percentage of previous traditional MIPS
quality submissions discussed in
section V.B.8.e.(7)(a)(i).of this proposed
rule, we are unable to determine how
many additional clinicians or practices
would report the Value in Primary Care
MVP for the CY 2025 performance
period/2027 MIPS payment year above
our current MVP submission estimates.
Similarly, we cannot assess what
participation levels clinicians or
practices who may use these APCM
codes, if finalized, have reported MIPS
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in the past (for example, eligibility
requirements and special statuses,
participation at the individual, group,
virtual group, or Alternative Payment
Model (APM) Entity level, or reporting
via traditional MIPS, the APM
Performance Pathway (APP), or MVPs),
or if they will be MIPS eligible
clinicians in future years. We refer
readers to section II.G.2. of this
proposed rule for details on this
proposal, and section VII.E.17.e.(2)(f) for
additional discussion on burden
impacts to the Quality Payment
Program.
In the CY 2024 PFS final rule (88 FR
79442), we conducted an analysis to
calculate the average quality measure
submission rate for each newly
proposed MVP for the CY 2024
performance period/2026 MIPS
payment period, using measures
submissions in the CY 2021
performance period/2023 MIPS
payment year for clinicians with
relevant clinical specialties for each
proposed MVP. 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 added this
incremental increase of 2 percentage
points to the previously approved
estimate in the CY 2023 PFS final rule
that 12 percent of clinicians who
participated in MIPS for the CY 2021
performance period/2023 MIPS
payment year will submit data for the
quality performance category through
MVP reporting in the CY 2023
performance period/2025 MIPS
payment year (88 FR 79443).
With updated submission data
available for the CY 2022 performance
period/2024 MIPs payment year as
discussed in section V.B.8.e.(3). of this
proposed rule and updated quality
measure list revisions within the MVP
inventory for the CY 2024 performance
period/2026 MIPS payment year (88 FR
79978 through 80047), we conducted
the analysis identified in the preceding
paragraph for the 16 MVPs approved for
the CY 2024 performance period/2026
MIPS payment year. The total of these
average quality measure submissions for
each approved MVP was equivalent to
6 percent of the total quality measure
submissions in the CY 2022
performance period/2024 MIPS
payment year. This is a decrease from
the 14 percent estimate provided in the
CY 2024 PFS final rule (88 FR 79443).
As discussed in section IV.A.4.a.(1).
of this proposed rule, we are proposing
modifications to the 16 MVPs approved
for the CY 2024 performance period/
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2026 MIPS payment year reporting with
the addition and removal of measures
and improvement activities based on the
MVP development criteria (85 FR 84849
through 84854). We are proposing to
consolidate the previously finalized
Optimal Care for Patients with Episodic
Neurological Conditions MVP and
Supportive Care for Neurodegenerative
Conditions MVP into a consolidated
neurological MVP titled Quality Care for
Patients with Neurological Conditions.
We are also proposing to add six (6) new
MVPs to the MVP inventory. These
proposals would provide 21 MVPs for
the CY 2025 performance period/2027
MIPS payment year.
For each newly proposed MVP, we
similarly calculated the average quality
measure submission rate across the
measures available in each MVP for the
CY 2022 performance period/2024 MIPS
payment year. Using updated data
available from the CY 2022 performance
period/2024 MIPS payment year, we
calculated that the total of these average
quality measure submissions for each
proposed MVP was equivalent to about
4 percent of total quality measure
submissions. We assume there would
not be any changes to MVP submissions
due to the proposal to consolidate the
measures in the Optimal Care for
Patients with Episodic Neurological
Conditions MVP and Supportive Care
for Neurodegenerative Conditions MVP
into the Quality Care for Patients with
Neurological Conditions MVP. That is,
we assume clinicians who would have
submitted the Optimal Care for Patients
with Episodic Neurological Conditions
MVP or the Supportive Care for
Neurodegenerative Conditions MVP
would instead submit the Quality Care
for Patients with Neurological
Conditions MVP. Therefore, we estimate
the proposed changes to the MVP
inventory in this proposed rule will
result in an additional 4 percent of
MIPS clinicians moving from traditional
MIPS to MVP reporting.
Taking together the aforementioned
analyses where we assessed the MVP
participation rate for the 16 established
MVPs at 6 percent using updated
quality measure submission data from
the CY 2022 performance period/2024
MIPS payment year, and the assessment
that 4 percent of MIPS clinicians may
move to the six proposed MVPs due to
quality measure submission trends for
the CY 2022 performance period/2024
MIPS payment year, we estimate that a
total of 10 percent of the clinicians will
participate in MVP reporting in the CY
2025 performance period/2027 MIPS
payment year. This is a decrease of 4
percentage points from the currently
approved estimate of 14 percent in the
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CY 2024 PFS final rule (88 FR 79443).
This decrease reflects the updated
analysis of MVP submissions for
established MVPs (from 14 percent to 4
percent) to account for the latest
available MIPS submission data, and the
additional 6 percent of MIPS clinicians
we believe may report the 6 newly
proposed MVPs due to updated quality
measure submission data.
Continuing our approach used in the
CY 2022, CY 2023, and CY 2024 PFS
final rules (86 FR 65589 and 65590, 87
FR 70156 and 701566, and 88 FR 79443
and 79444, respectively), we assume
that the number of MVP registrations
will equal our estimated MVP quality
submissions. We note the MVP
registration window for the 12 MVPs
available for the CY 2023 performance
period/2025 MIPS payment year closed
on November 30, 2023. As noted in
section IV.A.3.b.(2). of this proposed
rule, we received over 750 MVP
registrations for the CY 2023
performance period/2025 MIPS
payment year. MIPS submission data for
the CY2023 performance period/2025
MIPS payment year was unavailable
while preparing these burden estimates.
We will reassess our approach as
needed in future rules when both MVP
registration and submission data are
available for the same performance
period.
(i) Burden for MVP Registration:
Individuals, Groups and APM Entities
We refer readers to the CY 2024 PFS
final rule (88 FR 79443 and 79444) for
our previously finalized burden relevant
to MVP registration for clinicians
participating as an individual and/or
group for MVP reporting.
In the CY 2022 PFS final rule (86 FR
65414), we finalized at
§ 414.1365(c)(4)(ii) that an MVP
Participant is scored on one population
health measure in accordance with
§ 414.1365(d)(1). Since the MVP
population health measures are
administrative claims-based, they do not
require data submission from clinicians
and do not contribute to reporting
burden. To track which population
health measure an MVP Participant
intends to report, we finalized in the CY
2022 PFS final rule (86 FR 65417) at
§ 414.1365(b)(2)(i) that MVP
Participants are required to select one
population health measure at the time of
MVP registration.
MVP Participants currently select one
population measure during registration
(86 FR 65589), via a drop-down list. In
section IV.A.4.b.(1)(b) of this proposed
rule, we are proposing to update the
registration process and scoring policies
for population health measures in the
quality performance category. We are
proposing to revise
§ 414.1365(d)(3)(i)(A) to state that for
the CY 2023 through 2024 performance
periods/2025 through 2026 MIPS
payment years, MVP Participants will
be scored on the selected population
health measure and beginning in the CY
2025 performance period/2027 MIPS
payment year, we would use the highest
score of all available population health
measures. To apply this policy to
subgroups reporting an MVP, we also
propose to update
§ 414.1365(d)(3)(i)(A)(1) to provide that
for the CY 2023 through 2024
performance periods/2025 through 2026
MIPS payment years, subgroups will be
scored on the selected population health
measure based on its affiliated group
score, if available, and beginning in the
CY 2025 performance period/2027 MIPS
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payment year a subgroup is scored on
the highest score of all available
population health measures based on its
affiliated group score, if available. We
propose to revise § 414.1365(b)(2)(i) to
provide that beginning in the CY 2025
performance period/2027 MIPS
payment year, each MVP Participant
must select an MVP and any outcomesbased administrative claims-based
measure on which the MVP Participant
intends to be scored. We refer readers to
section IV.A.4.b.(1) of this rulemaking
for details on this proposal and scoring
implications. This proposal would
remove the requirement for the MVP
Participant to select a population health
measure during MVP registration. We
assume the associated reduction in
burden per application would be
minimal. Therefore, we are not
adjusting the burden per MVP
registration from the currently approved
registration time of 15 minutes (0.25 hr)
(88 FR 79443 and 79444).
As discussed, we estimate that
approximately 10 percent of the
clinicians that currently participate in
MIPS will submit data for the measures
and activities in an MVP. For the CY
2025 performance period/2027 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 6,285. In Table 103, we estimate that
it will take 1,571 hours (6,285 responses
× 0.25 hr/response) at a cost of $167,432
(6,285 registrations × $26.64/
registration) for individual clinicians,
groups and APM Entities to register for
MVP reporting in the CY 2025
performance period/2027 MIPS
payment year.
TABLE 103: Estimated Burden for MVP Registration (Individuals, Groups, Subgroups,
and APM Entities)
In Table 104, we illustrate the net
change in burden for MVP registration
using the currently approved burden in
the CY 2024 PFS final rule (88 FR 79443
and 79444). In aggregate, for the CY
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2025 performance period/2027 MIPS
payment year, the change in the number
of respondents expected to register for
MVP reporting from 9,585 to 6,285 will
result in a decrease of 3,300 responses.
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Burden Estimate
6,285
In aggregate, when combined with the
currently approved per response time
estimate, this will result in a decrease of
825 hours (¥3,300 responses × 0.25hr/
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Estimated# of Individual Clinicians, Groups, Subgroups and APM Entities
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response) at a cost of ¥$87,912 (¥3,300
responses × $26.64/response).
TABLE 104: Change in Estimated Burden for MVP Registration (Individuals, Groups,
Subgroups, and APM Entities)
Burden and Respondent Descriptions
Burden Estimate
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(ii) Burden for Subgroup Registration
We are not proposing any changes to
our currently approved subgroup
registration burden (86 FR 65590) of 10
annual hours (20 responses at 0.5hr/
response). As discussed in section
V.B.8.e.(7)(a) of this proposed rule, we
assume the proposal to remove the
selection of a population health measure
at the time of registration, as detailed in
section IV.A.4.b.(1)(b). of this proposed
rule, will not significantly impact the
currently approved burden for MVP
registration. We continue this
assumption to subgroup registration.
Therefore, we are continuing our
currently approved burden for subgroup
registration time of 30 minutes (0.5 hr).
We expect clinician participation in
subgroups will be relatively low for the
CY 2025 performance period/2027 MIPS
payment year due to the voluntary
subgroup reporting option and the
additional burden involved for groups
to organize clinicians into subgroups.
Therefore, we are not proposing any
adjustments to our previously finalized
estimate in the CY 2022 PFS final rule
(86 FR 65590) that 20 subgroups will
participate in MVP reporting.
As identified in section IV.A.3.c.(1) of
this proposed rule, we finalized a
mandatory subgroup reporting
requirement for multispecialty groups
choosing to report as an MVP
Participant beginning in the CY 2026
performance period/2028 MIPS
payment year (§ 414.1305; 86 FR 65394
through 65397). Section IV.A.3.d. of this
proposed rule includes a Request for
Information (RFI) to obtain feedback on
what guidance/parameters are needed
for multispecialty groups to place
clinicians into subgroups for reporting
an MVP relevant to the scope of care
provided. Absent available submission
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data on MVP reporting as discussed in
section V.B.8.e.(7)(a). of this proposed
rule, we are unable to estimate the effect
of this established policy on reporting
for the CY 2026 performance period/
2028 MIPS payment. We refer readers to
section VII.E.17.e.(2)(g). of this proposed
rule for additional discussion on burden
impacts of this established policy to the
Quality Payment Program.
The burden relevant to the subgroup
registration requirement is currently
approved by OMB under control
number 0938–1314 (CMS–10621). Since
this rulemaking is not proposing any
new or revised subgroup registration
requirements or burden, we are not
proposing any changes under that
control number.
(iii) Burden for MVP Quality
Performance Category Submission
In the CY 2022 PFS final rule (86 FR
65411 through 65415), we finalized the
reporting requirements for the MVP
quality performance category at
§ 414.1365(c)(1)(i).
In sections IV.A.4.d.(2)(b). and
IV.A.4.d.(3).(b). of this proposed rule,
we are proposing to adopt minimum
criteria for a qualifying data submission
for a MIPS performance period for the
quality performance category and to
codify our existing policies governing
our treatment of multiple submissions
received for the quality performance
category. In accordance with our
discussion of this policy proposal
relevant to traditional MIPS quality
reporting in section V.B.8.e.(2). of this
proposed rule, these proposed policies
will not introduce new requirements to
submit data for the quality performance
category of MVPs. Therefore, we are
continuing our currently approved per
response time estimates for submitting
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the MVP quality performance category
data due to this proposal.
As described in section V.B.8.e.(7)(a)
of this proposed rule, we estimate that
10 percent of the clinicians who
participated in MIPS for the CY 2022
performance period/2024 MIPS
payment year will submit data for the
quality performance category of MVP in
the CY 2025 performance period/2027
MIPS payment year. We also estimate
there will be 20 subgroup reporters in
the CY 2025 performance period/2027
MIPS payment year. In Table 105, we
estimate that 3,020 clinicians and 10
subgroups will submit data using
eCQMs collection type at $644.93/
response (see line q for eCQMs); 1,890
clinicians and 10 subgroups will submit
data using MIPS CQM and QCDR
collection type at $716.31/response (see
line q for CQM and QCDRs); and 1,355
clinicians and 0 subgroups will submit
data for the MVP quality performance
category using the Medicare Part B
claims collection type at $1,101.24/
response (see line q for claims). For the
CY 2025 performance period/2027 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 16,059 hours [5.3 hr × 3,030
(3,020 + 10) responses] at a cost of
$1,954,138 (3,030 responses × $644.93/
response) for the eCQM collection type,
11,343 hours [5.97 hr × 1,900 (1,890 +
10 responses)] at a cost of $1,360,989
(1,900 responses × $716.31/response) for
the MIPS CQM and QCDR collection
type, and 12,791 hours (9.44 hr × 1,355
clinician responses) at a cost of
$1,492,180 (1,355 responses ×
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2,396
1,571
Total Currentl A roved Annual Hours a
Total Annual Hours for Respondents in CY 2025 PFS Proposed Rule (b) (See
Table 103, row c
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$1,101.24/response) for the Medicare
Part B claims collection type.
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BILLING CODE P
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TABLE 105: Estimated Burden for MVP Quality Performance Category
Submission
Burden and Respondent
Descriptions
# of Submissions from Pre-existing
collec
eCQM Collection
Type
3,020
CQM and QCDR
Collection Type
1,890
Claims Collection
Type
1,355
Hours Per Computer Systems
Anal st to Sub
Data d
# of Hours Medical and Health
Services Manager Review Measure
1.33
2
4.8
1.33
1.33
2
0.66
0.66
0.66
0.66
0.66
0.66
# of Hours Billing Clerk Review
Measure S ecifications h
# of Hours Physician Review
Measure S
Annual Hours per Clinician
Submitting Data for MVPs U) = (d) +
0.66
0.66
0.66
0.66
0.66
0.66
5.3
5.97
9.44
Cost to Submit Quality Data (at
Computer Systems Analyst's Labor
Rate of $106.54/hr) (I) = $106.54/hr
x d va in times
Cost to Review Measure
Specifications (at Medical and
Health Services Manager's Labor
Rate of$129.28/hr) (m) = $129.28/hr
x e va in times
Cost to Review Measure
Specifications (at Computer Systems
Analyst's Labor Rate of$106.54/hr)
n = $106.54/hr X
Cost to Review Measure
Specifications (at LPN's Labor Rate
of $58.46/hr o = $58.46/hr x
Cost to Review Measure
Specifications (at Billing Clerk's
Labor Rate of$45.32/hr) (p) =
$45.32/hr x (h)
Cost to Review Measure
Specifications (at Physician's Labor
Rate of$291.64/hr) (q) = $291.64/hr
X (i)
Total Annual Cost Per Submission
(r =(I +(m)+ n)+ o)+
$141.70
$213.08
$511.39
$171.94
$171.94
$258.56
$70.32
$70.32
$70.32
$38.58
$38.58
$38.58
$29.91
$29.91
$29.91
$192.48
$192.48
$192.48
$644.93
$716.31
$1,101.24
s
# of Hours Computer Systems
Analyst Review Measure
s
# of Hours LPN Review Measure
$1360,989
BILLING CODE C
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Table 106 illustrates the changes in
estimated burden for clinicians who
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will submit the MVP quality
performance category utilizing the
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eCQM, MIPS CQM and QCDR, and
Medicare Part B claims collection types
in the CY 2025 performance period/
2027 MIPS payment year. We note we
used the currently approved burden in
the CY 2024 PFS final rule (88 FR 79444
through 79446) as the baseline to
determine the net change in burden. In
aggregate, when combined with our
currently approved per response time
estimate, the decrease in 3,300
respondents who will submit data for
the MVP quality performance category
will result in a change of ¥8,766 hours
62139
and ¥$1,066,714 for the eCQM
collection type, ¥4,877 hours and
¥$585,225 for the CQM and QCDR
collection type, and ¥7,826 hours and
¥$912,928 for the Medicare Part B
claims collection type.
TABLE 106: Change in Estimated Burden for MVP Quality Performance Category
Submission
CQM
C II c t· T
o cc 1011 ypc
CQM and
QCDR
C 0 11 CC t·IOU T ypc
Cl •
C II t~imsT
o cc IOU ypc
16,059
11,343
12,791
Total Annual Hours for Respondents in CY 2025
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(8) Beneficiary Responses to CAHPS for
MIPS Survey
We are not proposing any new or
revised collection of patient experience
information from survey respondents
during the administration of the CAHPS
for MIPS Survey for the CY 2025
performance period/2027 MIPS
payment year. We note that we
proposed updates to our estimated
burden under control number 0938–
1222 (CMS–10450) as discussed in the
CY 2024 PFS final rule (88 FR 79446
and 79447), which were submitted
under the standard non-rule PRA
package. The 60-day notice for public
comment for this PRA package appeared
in the Federal Register on October 17,
2023 (88 FR 71573), and the 30-day
notice for public comment appeared in
the Federal Register on January 16,
2024 (89 FR 2622). Since this
rulemaking is not proposing any new or
revised CAHPS for MIPS survey
requirements or burden for this ICR, we
are not proposing any changes for this
ICR under that control number.
(9) Group Registration for CAHPS for
MIPS Survey
We are not proposing any new or
revised collection of information
requirements or burden related to group
registration for the CAHPS for MIPS
Survey for the CY 2025 performance
period/2027 MIPS payment year. We
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note that we proposed updates to our
estimated burden under control number
0938–1222 (CMS–10450) as discussed
in the CY 2024 PFS final rule (88 FR
79447 and 79448), which were
submitted under the standard non-rule
PRA package. The 60-day notice for this
PRA package appeared in the Federal
Register on October 17, 2023 (88 FR
71573), while the 30-day notice
appeared on January 16, 2024 (89 FR
2622). Since this rulemaking is not
proposing any new or revised CAHPS
for MIPS survey requirements or burden
for this ICR, we are not proposing any
changes for this ICR under that control
number.
f. ICRs Regarding the Call for MIPS
Quality Measures
In this section of this proposed rule,
we identify proposed adjustments to the
estimated burden for the Call for MIPS
Quality Measures ICR, that will be
submitted to OMB for review under
control number 0938–1314 (CMS–
10621). These proposed adjustments are
summarized in Tables 78 and 79. We are
not proposing any new or revised
collection of information requirements
related to the call for MIPS quality
measures. However, based on quality
measure submissions received for CMS’
consideration during the 2023 MIPS
Annual Call for Quality Measures, we
are adjusting our burden estimates for
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the CY 2025 performance period/2027
MIPS payment year. In the CY 2024 PFS
proposed rule (88 FR 52662) and the CY
2024 PFS final rule (88 FR 79448), we
inadvertently noted we that we derived
our estimates of 31 responses from
submissions during the 2023 MIPS
Annual Call for Quality Measures; we
derived these estimated response from
data for the 2022 MIPS Annual Call for
Quality Measures. The proposed
estimates in this proposed rule reflect
submission changes from the 2022 and
2023 MIPS Annual Call for Quality
Measures, and do not reflect proposed
policies or statute changes in this
proposed rule.
In this proposed rule, we estimate that
we will receive 16 quality measure
submissions during the 2025 MIPS
Annual Call for Quality Measures, a
decrease of 15 from the currently
approved number of quality measure
submissions for consideration (88 FR
79448 and 79449). 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 107, we estimate an annual
burden of 88 hours (16 measure
submissions × 5.5 hr/measure) at a cost
of $19,430 (16 measure submissions ×
$1,214.35/submission for the CY 2025
performance period/2027 MIPS
payment year).
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TABLE 107: Estimated Burden for Call for Quality Measures
Burden and Respondent Descriptions
Burden Estimate
Cost to Identify and Submit Measure (at Medical and Health Services Manager's Labor Rate
of$129.28/hr ( ) = $129.28/hr x
Cost to Identify Quality Measure and Complete Peer Review Article Form (at Clinician's
Labor Rate of$291.64/hr) (h) = $291.64/hr x [(c) + (d)]
Total Annual Cost Per Submitted Measure
In Table 108, we illustrate the net
change in estimated burden for the call
for quality measures using the currently
approved burden in the CY 2024 PFS
final rule (88 FR 79448 and 79449). In
aggregate, the estimated decrease in the
number of quality measure submissions
will result in an adjustment of ¥83
hours (¥15 measure submissions × 5.5
hr/measure submission) at a cost of
$310.27
$904.08
¥$18,215 (¥15 measure submissions ×
$1,214.35/measure submission) for the
CY 2025 performance period/2027 MIPS
payment year.
TABLE 108: Change in Estimated Burden for Call for Quality Measures
Burden and Respondent Descriptions
Burden Estimate
171
88
Total Annual Hours for Respondents in CY 2025 PFS Proposed
Rule
See Table 107, row
For the CY 2025 performance period/
2027 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
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analyzed data submitted by MIPS
eligible clinicians, groups, subgroups
and APM Entities, and assessed
clinician performance based on all the
four MIPS performance categories, as
applicable.
(2) Reweighting Applications for MIPS
Performance Categories
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
Quality Payment Program final rule (81
FR 77240 through 77243), CY 2018
Quality Payment Program final rule (82
FR 53918 and 53919), and the CY 2019,
CY 2020, CY 2021, CY 2022, CY 2023,
and CY 2024 PFS final rules (83 FR
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(1) Background
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
EP31JY24.147
g. ICRs Regarding Promoting
Interoperability Data (§§ 414.1375 and
414.1380)
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60011 and 60012, 84 FR 63134 and
63135, 85 FR 84984 and 84985, 86 FR
65596 through 65598, 87 FR 70160
through 70162, and 88 FR 79449 and
97450, respectively) for our previously
finalized requirements for, and our
analysis of the information collection
and reporting burden associated with,
reweighting applications for the four
MIPS 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, significant hardship, or
other exceptions (81 FR 77240 through
77243, 82 FR 53680 through 53686, and
82 FR 53783 through 53785).
Respondents (MIPS eligible
individual clinicians, groups, or APM
Entities) who apply for 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
online form. We assume respondents
applying for a reweighting of the
Promoting Interoperability performance
category due to extreme and
uncontrollable circumstances 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.i.(2) of this proposed
rule, we are proposing to adopt a new
reweighting policy at
§ 414.1380(c)(2)(i)(A)(10) and
(c)(2)(i)(C)(12). Specifically, we are
proposing that, beginning with the CY
2024 performance period/2026 MIPS
payment year, that we may reweight one
or more of the performance categories
(that is, quality, improvement activities,
or Promoting Interoperability) where we
determine, based on information
submitted to us on or before November
1st of the year preceding the relevant
MIPS payment year, that data for a MIPS
eligible clinician are inaccessible or
unable to be submitted due to
circumstances outside of the control of
the clinician because the MIPS eligible
clinician delegated submission of the
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data to their third party intermediary,
evidenced by a written agreement
between the MIPS eligible clinician and
third party intermediary, and the third
party intermediary did not submit the
data for the performance category(ies)
on behalf of the MIPS eligible clinician
in accordance with applicable
deadlines. Since MIPS eligible
clinicians do not submit data separately
for measures in the cost performance
category and we score cost measures
based solely on Medicare claims data,
the proposed reweighting policy does
not apply to the cost performance
category. We also are proposing that, to
determine whether to apply reweighting
to the affected performance
category(ies), we would consider:
whether the MIPS eligible clinician
knew or had reason to know of the issue
with its third party intermediary’s
submission of the clinician’s data for the
performance category(ies); whether the
MIPS eligible clinician took reasonable
efforts to correct the issue; and whether
the issue between the MIPS eligible
clinician and their third party
intermediary caused no data to be
submitted for the performance
category(ies) in accordance with
applicable deadlines. Because we
believe these occurrences would be rare
based on our experience with related
requests for reweighting, and the extent
and source of documentation provided
to us for each event may vary
considerably, we are not proposing any
changes to our currently approved
burden estimates for this proposal. We
refer readers to section VII.E.17.e.(2)(e).
of this proposed rule for additional
discussion on these burden estimates.
Table 109 summarizes our analysis of
the estimated burden, including for
MIPS eligible clinicians to apply for
reweighting of one or more of the MIPS
performance categories to zero percent
due to an extreme or controllable
circumstance, significant hardship, or
other exception as provided in
§ 414.1380(c)(2)(i).
We are updating our burden estimates
relevant to this ICR based on the
number of reweighting applications
received for the CY 2023 performance
period/2025 MIPS payment year by
January 2, 2024, that do not cite the
public health emergency (PHE) for
COVID–19 (PHE for COVID–19) as the
basis for reweighting. The Federal PHE
for COVID–19 under section 319 of the
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Public Health Service Act ended on May
11, 2023.789 As a result of the end of the
PHE, MIPS eligible clinicians will no
longer be able to submit a reweighting
application citing hardships from the
PHE for COVID–19; therefore, we are
excluding reweighting applications
citing the PHE for COVID–19 in our
estimate for CY 2025 performance
period/2027 MIPS payment year
reweighting applications. In this
proposed rule, we estimate that we will
receive a total of 3,297 applications to
request reweighting for any or all of the
four MIPS performance categories for
the CY 2025 performance period/2027
MIPS payment year. Of the 3,297, we
estimate that 2,490 MIPS eligible
clinicians or groups will submit a
request that includes reweighting 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).
and we estimate that 802 MIPS eligible
clinicians or groups will submit a
request to reweight one or more of the
MIPS performance categories as
provided in § 414.1380(c)(2)(i).
Additionally, we estimate 5 APM
Entities will submit an extreme and
uncontrollable circumstances exception
application to reweight one or more
MIPS performance category for the CY
2025 performance period/2027 MIPS
payment year. This adjustment, due to
both updated data and the end of the
PHE for COVID–19, results in a decrease
of 25,930 respondents compared to our
currently approved estimate of 29,227
respondents (88 FR 79449 and 79450).
We note the currently approved
estimate included reweighting
applications citing the PHE for COVID–
19.
Consistent with our assumptions in
the CY 2024 PFS final rule (88 FR 79449
and 79450), we continue to estimate it
will take 0.25 hours at $106.54/hr for a
computer system analyst to complete
and submit the reweighting application.
In Table 109, we estimate an annual
burden of 824 hours (3,297 applications
× 0.25 hr/application) at a cost of
$87,832 (3,297 applications × $26.64/
application) for the CY 2025
performance period/2027 MIPS
payment year.
789 https://www.hhs.gov/coronavirus/covid-19public-health-emergency/.
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TABLE 109: Estimated Burden for Reweighting Applications for MIPS Performance
Categories
Burden and Respondent Descriptions
Burden Estimate
# of Eligible Clinicians or Groups Applying Due to Significant Hardship and Other
Exce tions or Extreme and Uncontrollable Circumstances a
In Table 110, we illustrate the net
change in estimated burden for
submission of reweighting applications
for MIPS performance categories using
the currently approved burden in the
CY 2024 PFS final rule (88 FR 79449
and 79450). The adjustment in the
estimated number of respondents, from
29,227 to 3,297 respondents, results in
a decrease of 25,930 respondents. In
aggregate, using our currently approved
per response time estimate, as shown in
3,292
Table 110, the decrease in 25,930
respondents results in an adjustment of
¥6,483 hours and ¥$690,775 the CY
2025 performance period/2027 MIPS
payment year.
Burden Estimate
Total Currentl A roved Annual Hours in CY 2024 PFS Final Rule a
Total Annual Hours for Respondents in CY 2025 PFS Proposed Rule (b) (See
Table 1
7,307
824
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(3) Submitting Promoting
Interoperability Data
The following proposed changes
relevant to the submission of Promoting
Interoperability data requirements and
burden will be submitted to OMB for
review under OMB under control
number 0938–1314 (CMS–10621).
We note that we adjusted the burden
estimates from the currently approved
CY 2024 PFS final rule (88 FR 79451
through 79453) to incorporate updated
available MIPS submission data for the
CY 2022 performance period/2024 MIPS
payment year, as discussed in section
V.B.8.e.(3). of this proposed rule. We are
not proposing changes based on the
proposals discussed in section IV.A. of
this proposed rule. In the following
paragraphs, we discuss these proposed
policies and our rationale for
maintaining the currently approved
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burden for the submission of Promoting
Interoperability data requirements.
We refer readers to the CY 2017 and
CY 2018 Quality Payment Program final
rules (81 FR 77509 through 77511, and
82 FR 53919 and 53920, respectively),
and the CY 2019, CY 2020, CY 2021, CY
2022, CY 2023, and CY 2024 PFS final
rules (83 FR 60013 and 60014, 84 FR
63135 through 63137, 85 FR 84985
through 84987, 86 FR 65598 through
65600, 87 FR 70162 through 70164, and
88 FR 79451 through 79453,
respectively) for our previously
finalized requirements and burden for
submission of data for the Promoting
Interoperability performance category.
We refer readers to § 414.1375 for our
previously established policies
regarding reporting for the Promoting
Interoperability performance category.
We also refer readers to § 414.1305 for
the definition of attestation, § 414.1325
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for data submission requirements, and
§ 414.1380(b)(4) for Promoting
Interoperability performance category
scoring. We refer readers to
§ 414.1380(c)(2)(i)(C) for our previously
finalized policies regarding scoring of
data submission in the Promoting
Interoperability performance category
after an approved reweighting for the
performance category.
In section IV.A.4.d.(2)(d) of this
proposed rule, we are proposing to
adopt minimum criteria for a qualifying
data submission for the Promoting
Interoperability performance category at
§ 414.1325(a)(1)(iii). Currently, an
incomplete data submission would void
an approved reweighting of the
Promoting Interoperability performance
category in accordance with
§ 414.1380(c)(2)(i)(C). This proposal
would clarify what counts as a data
submission for MIPS eligible clinicians
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Burden and Respondent Descriptions
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TABLE 110: Change in Estimated Burden for Reweighting Applications for MIPS
Performance Categories
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and it would potentially avoid partial
data submissions from overriding an
approved reweighting or a previously
scored submission for the Promoting
Interoperability performance category.
Specifically, we propose that a
qualifying data submission for the
Promoting Interoperability performance
category must include all the following
elements: (1) performance data,
including any claim of an applicable
exclusion, for the measures in each
objective, as specified by CMS; (2)
required attestation statements, as
specified by CMS; specified by CMS; (3)
CMS EHR Certification ID (CEHRT ID)
from the Certified Health IT Product List
(CHPL); and (4) the start date and end
date for the applicable performance
period as set forth in § 414.1320. If we
receive a qualifying data submission
meeting the proposed minimum criteria
for reporting, then we will review the
data submission and score the
Promoting Interoperability performance
category in accordance with our
applicable scoring policies. We refer
readers to section IV.A.4.d.(2)(d) of this
proposed rule for additional background
and details on this proposal. We are not
proposing any changes to the existing
scoring or reweighting policies
described under § 414.1380 for the MIPS
performance categories in this section
IV.A.4.d. Our current estimates assume
that PI submissions include all
requirements for scoring; therefore, we
are not adjusting our established per
response time estimate.
In section IV.A.4.d.(3)(c). of this
proposed rule, we are also proposing to
modify our policy governing our
treatment of multiple data submissions
received for the Promoting
Interoperability performance category,
which we propose to codify at
§ 414.1325(f)(2). Specifically, we are
proposing that, in cases where CMS
receives multiple submissions for the
Promoting Interoperability performance
category, CMS would calculate a score
for each data submission received and
assign the highest of the scores.
In our analysis of the information
collection and reporting burden, we are
not adjusting our estimated number of
respondents submitting Promoting
Interoperability data. These proposals
intend to significantly reduce certain
issues with the scoring of unintended
data submissions affecting MIPS
payment adjustments for individual
MIPS eligible clinicians, groups, virtual
groups, subgroups, and APM Entities.
These two proposals may limit the
unintentional overriding of an approved
reweighting or an existing scoreable
submission. Our currently approved per
response estimates incorporate the
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required measures and attestations and
other required data elements identified
in sections IV.A.4.d.(2)(d). and
IV.A.4.d.(3)(c). of this proposed rule.
In the CY 2022 PFS final rule, we
finalized at § 414.1365(c)(4)(i) that an
MVP Participant is required to meet the
Promoting Interoperability reporting
requirements. We also finalized at
§ 414.1365(c)(4)(i)(A) the requirements
for a subgroup participating in MVP
reporting (86 FR 65413 and 65414).
Specifically, we stated that for the CY
2023 and 2024 MIPS performance
periods/2025 and 2026 MIPS payment
years, an MVP Participant that is a
subgroup is required to submit its
affiliated group’s data for the Promoting
Interoperability performance category.
The submission of the affiliated group’s
data will be on the subgroup’s behalf. If
the affiliated group chooses to report as
a group for the Promoting
Interoperability performance category,
the group will still be required to submit
its own data separately and in
accordance with the reporting rules for
groups. In section IV.A.4.b.(4). of this
rulemaking, we are proposing to modify
§ 414.1365(c)(4)(i)(A) by removing the
references to the specific MIPS
performance periods/payment years to
state that an MVP Participant that is a
subgroup is required to submit its
affiliated group’s data for the Promoting
Interoperability performance category.
The proposed change would allow a
subgroup to submit the affiliated group’s
data for the MVP Promoting
Interoperability performance category
for the CY 2025 performance period/
2027 MIPS payment year and beyond.
As this proposal would not create new
reporting requirements, there are no
burden implications for this proposal.
The Department of Health and Human
Services (HHS) final rule, 21st Century
Cures Act: Establishment of
Disincentives for Health Care Providers
That Have Committed Information
Blocking (hereafter referred to as the
Disincentives final rule) was released on
June 24, 2024 (https://www.healthit.gov/
topic/informationblocking#Disincentives). Section
IV.A.4.e.(4)(d). of this proposed rule
summarizes several policies in the
Disincentives final rule under which a
MIPS eligible clinician that the Office of
Inspector General determines has
committed information blocking would
not be a meaningful EHR user, and
therefore would be unable to earn a
score (instead earning a score of zero)
for the Promoting Interoperability
performance category. We note the
Disincentives final rule described in
section IV.A.4.e.(4)(d). of this proposed
rule would not create any additional
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62143
reporting, recordkeeping, or third party
disclosure requirements. Consequently,
we are not proposing any updates in
this proposed rule.
In sections IV.A.4.e (4)(e)(iii) of this
proposed rule, we note that we recently
released the CMS Interoperability and
Prior Authorization final rule which
appeared in the Federal Register on
February 8, 2024 (89 FR 8758). In the
CMS Interoperability and Prior
Authorization final rule final rule, we
finalized the addition of a new measure,
the ‘‘Electronic Prior Authorization’’
measure, under the Health Information
Exchange (HIE) objective for the MIPS
Promoting Interoperability performance
category beginning with the CY 2027
performance period/2029 MIPS
payment year (89 FR 8909 through
8927). The burden estimate for MIPS
clinicians to report the ‘‘Electronic Prior
Authorization measure’’ was provided
in the CMS Interoperability and Prior
Authorization final rule (89 FR 8953
through 8956). In the CMS
Interoperability and Prior Authorization
final rule final rule, we identified that
this measure will be included in a PRA
package related to the CMS
Interoperability and Prior Authorization
final rule (89 FR 8946). Consequently,
we are not proposing any updates in
this proposed rule.
Due to the availability of updated data
on the Promoting Interoperability
submissions during the CY 2022
performance period/2024 MIPS
payment year, we are adjusting our
currently approved estimated burden for
the submission of data in Promoting
Interoperability performance category
(88 FR 79451 and 79452). In Table 111,
we estimate that a total number of
18,609 respondents, consisting of 14,500
individual MIPS eligible clinicians,
4,089 groups and virtual groups, and 20
subgroups will submit data for the
Promoting Interoperability performance
category in the CY 2025 performance
period/2027 MIPS payment year.
As noted in section V.B.8.a.(1)(a) of
this proposed rule, we have not updated
our Quality Payment Program burden
estimates to reflect MIPS Promoting
Interoperability reporting requirements
of non-MIPS eligible clinicians due to
requirements for the Shared Savings
Program. For MIPS eligible clinicians
participating in an APM, we continue
our assumption from the CY 2023 PFS
final rule (87 FR 70163) and CY 2024
PFS final rule (88 FR 79451) that each
MIPS eligible clinician in an APM
Entity reports data for the Promoting
Interoperability performance category
through either their group TIN or
individual reporting in the CY 2019 PFS
final rule, we established that MIPS
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eligible clinicians who participate in the
Shared Savings Program are no longer
limited to reporting for the Promoting
Interoperability performance category
through their ACO participant TIN (83
FR 59822 and 59823). Burden estimates
for this proposed rule assume group
TIN-level reporting as we believe this is
the most reasonable assumption for
MIPS eligible clinicians in the Shared
Savings Program, which requires that
ACOs include full TINs as ACO
participants. Accordingly, we assume
that any Promoting Interoperability data
submitted at the APM-Entity level
adheres to APM or Shared Savings
Program requirements. Sections 1899
and 1115A of the Act (42 U.S.C. 1395jjj
and 42 U.S.C. 1315a, respectively) state
that the Shared Savings Program and the
testing, evaluation, and expansion of
Innovation Center models are not
subject to the PRA.
TABLE 111: Estimated Number of Respondents to Submit Promoting
Interoperability Performance Data
Burden and Respondent Descriptions
# of Respondents
# of Individual Clinicians to Submit Promoting Interoperability in CY 2025 Performance
Period (a)
# of Groups to Submit Promoting Interoperability in CY 2025 Performance Period (b)
14,500
4,089
20
# of Subgroups to Submit Promoting Interoperability in MVPs during the CY 2025
erformance Period c
18,609•
25,990
Currently Approved Respondents (2024 PFS Final Rule) (e)
iffereuce ill# of Respondents (t)
As shown in Table 112, we are
continuing our currently approved
estimated time of 2.70 hours per
response. Therefore, we estimate that it
will result in a total burden of 50,244
hours (18,609 respondents × 2.70
={d)-(e) •
incremental hours for a computer
analyst’s time above and beyond the
physician, medical and health services
manager, and computer system’s analyst
time required to submit quality data)
and $5,353,065 (18,609 responses ×
$287.66/response) to submit data for the
Promoting Interoperability performance
category in the CY 2025 performance
period/2027 MIPS payment year.
TABLE 112: Estimated Burden for Promoting Interoperability Performance Category
Data Submission
Burden and Respondent Description
Burden Estimate
umber oflndividual Clinicians to Submit Promoting Interoperability (a)
14,500
umber of Groups to Submit Promoting Interoperability (b)
4,089
umber of Subgroups to Submit Promoting Interoperability (c)
performance period/2027 MIPS
payment year. In aggregate, we estimate
that the decrease in the number of
respondents from 25,990 to 18,609 will
result in an adjustment of ¥19,929
hours (¥7,381 respondents × 2.70 hr/
response) and ¥$2,123,218.
EP31JY24.152
In Table 113, we illustrate the change
in burden for clinicians to submit data
in the Promoting Interoperability
performance category for the CY 2025
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TABLE 113: Change in Estimated Burden for Promoting Interoperability Performance
Category Data Submission
Burden and Respondent Description
Burden Estimate
Total Currently Approved Annual Hours (a)
70,173
Total Annual Hours for Respondents in CY 2025 PFS Proposed Rule (b) (see
Table I
50,244
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h. ICRs Regarding Improvement
Activities Submission (§§ 414.1305,
414.1355, 414.1360, and 414.1365)
The following proposed changes will
be submitted to OMB for review under
control number 0938–1314 (CMS–
10621)
We are not proposing changes due to
the improvement activities proposals
discussed in section IV.A. of this
proposed rule. In the following
paragraphs, we discuss these proposed
policies and our reasons for not
changing the currently approved per
response burden for improvement
activities submission.
In section IV.A.4.e.(3)(b)(iv) of this
proposed rule, we are proposing two
scoring and reporting policy changes for
the improvement activities performance
category effective for the CY 2025
performance period/2027 MIPS
payment year and subsequent years.
First, we are proposing to eliminate the
weighting of improvement activities. In
the CY 2017 Quality Payment Program
final rule, we established a differentially
weighted model for the improvement
activities performance category with
two categories, medium and high, to
provide flexible scoring (81 FR 28210).
In that rule (81 FR 77177 and 77178),
we codified at § 414.1380(b)(3) that
clinicians (except for non-patient facing
MIPS eligible clinicians, small practices,
and practices located in rural areas and
geographic health professional shortage
areas (HPSAs)) receive 10 points for
each medium-weighted improvement
activity and 20 points for each highweighted improvement activity. Nonpatient facing MIPS eligible clinicians,
small practices, and practices located in
rural areas and geographic HPSAs
receive 20 points for each mediumweighted improvement activity and 40
points for each high-weighted
improvement activity.
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Second, we are proposing to further
simplify improvement activity reporting
requirements by reducing the number of
activities to which clinicians are
required to attest to achieve a score in
the improvement activities performance
category, beginning in the CY 2025
performance period/2027 MIPS
payment year. Currently, MIPS eligible
clinicians are required to report two
high-weighted activities, four mediumweighted activities, or one highweighted and two medium-weighted
activities while MVP participants are
currently required to report one highweighted activity or two mediumweighted activities. We are proposing
that MIPS eligible clinicians who
participate in traditional MIPS would be
required to report two activities and
MVP participants would be required to
report one activity to achieve 40 points,
or full credit. In addition, we are
proposing that MIPS eligible clinicians
who are categorized as small practice,
rural, in a provider-shortage area, or
non-patient facing would now be
required to report one activity (for either
traditional MIPS or MVPs).
We established our currently
approved estimate that it will take a
computer analyst 5 minutes to log in
and manually attest that improvement
activities were completed in the CY
2019 PFS final rule (83 FR 60016). We
believe the proposed removal of
weighting for improvement activities
will decrease burden for MIPS eligible
clinicians who previously reported
medium-weighted activities. As MIPS
eligible clinicians who previously only
reported high-weighted activities will
have the same attestation requirements
under this proposal, we are not
proposing a change to our currently
estimated per response burden. We refer
readers to section VII.E.17.e.(2)(c). of
this proposed rule where we discuss our
impact analysis for this proposal.
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In section IV.A.4.e.(3)(b)(iii) of this
rulemaking, we are also proposing
changes to the improvement activities
inventory for the CY 2025 performance
period/2027 MIPS payment year and
future years as follows: adding two new
improvement activities; modifying two
existing improvement activities; and
removing eight previously adopted
improvement activities. In the CY 2023
PFS final rule (87 FR 70211) and the
2024 PFS final rule (88 FR 79519), we
anticipated that most clinicians
performing improvement activities, to
comply with existing MIPS policies,
will continue to perform the same
activities because previously finalized
improvement activities continue to
apply for the current and future years
unless otherwise modified per
rulemaking (82 FR 54175). We believe
this proposal will not significantly affect
burden because the majority of activities
are not revised. We refer readers to
section VII.E.17.e.(2)(b) of this proposed
rule where we discuss our impact
analysis for this proposal, and section
VII.E.17.e.(2)(c) where we discuss the
impact analysis for modifications to
modifications to improvement activities
scoring and reporting policies. As
discussed in section IV.A.4.d.(2)(c) in
this proposed rule, we previously
finalized at § 414.1360(a)(2) that MIPS
eligible clinicians, groups, virtual
groups, or subgroups must submit a yes
response for each improvement activity
that is performed for at least a
continuous 90-day period during the
applicable performance period to
receive points in the improvement
activities performance category
described under § 414.1360(b)(3). We
currently assign a score for any
submission or attestation received in the
improvement activities performance
category via the submission types
described under § 414.1325(a)(1)
regardless of whether the submission or
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attestation included a yes response or
not. Several MIPS eligible clinicians
have notified us that there have been
instances where they unintentionally
submitted non-scorable data for a MIPS
performance category, which overrode
an approved reweighting or a previously
scorable data submission for a
performance categories. In the event of
a submission without yes responses, we
currently assign a score of zero. In
section IV.A.4.d.(2)(c). of this proposed
rule, we are proposing to adopt
minimum criteria for a qualifying data
submission for a performance period for
the improvement activities performance
category. We are proposing to specify
what we consider to be a data
submission at § 414.1325(a)(1)(ii) to
state that for the improvement activities
performance category, a data submission
must include a response of ‘‘yes’’ for at
least one activity in the MIPS
improvement activities inventory. We
anticipate the proposed change would
potentially avoid unintentional
overriding of an approved reweighting
or a prior data submission for the
improvement activities performance
category due to submissions or
attestations without a response of ‘‘yes’’
for any of the improvement activities.
We note that we are not proposing any
changes to the data submission criteria
and scoring for the improvement
activities performance category
described under §§ 414.1360 and
414.1380(b)(3) respectively.
Additionally, we are proposing to
codify our existing policies governing
multiple data submissions received for
the improvement activities performance
category at § 414.1325(f)(1). We refer
readers to section IV.A.4.d.(3)(b) of this
proposed rule for details. These
proposals, if finalized, would not affect
the requirements for MIPS eligible
clinicians and groups that submit data
for the improvement activities
performance category. We assume these
proposals would not affect the number
improvement activities submissions, as
the intent is to eliminate certain issues
with the scoring of an unintended data
submission affecting payment
adjustments for individual MIPS eligible
clinicians, groups, virtual groups,
subgroups, and APM Entities. Therefore,
we are not proposing any adjustments to
our currently approved estimated
burden due to these policy proposals.
As shown in Table 114, we are
adjusting the currently approved burden
estimates (88 FR 79454 and 79455) due
to available updated submission data for
the CY 2022 performance period/2024
MIPS payment year, as discussed in
section V.B.8.e.(3). of this proposed
rule. As identified in Table 79, the
proposed change in burden reflects
adjustments for updated data, rather
than proposed requirements or statues
in this proposed rule. We estimate that
a total of 38,433 respondents consisting
of 29,017 individual clinicians, 9,396
groups and 20 subgroups will submit
improvement activities during the CY
2025 performance period/2027 MIPS
payment year. This adjustment
represents a decrease of 11,856
respondents from the currently
approved estimate of 50,289
respondents in the CY 2024 PFS final
rule (88 FR 79454 and 79455). We did
not include in our estimates clinicians
who participated in an APM Entity and
are determined to be QPs for the CY
2022 performance period/2024 MIPS
payment year as we assume they are not
required to submit improvement
activities data.
TABLE 114: Estimated Number of Respondents to Submit Improvement Activities Data
Burden and Respondent Descriptions
Count
# of Clinicians to Participate in Improvement Activities Data Submission as During the
CY 2025 Performance Period a
# of Groups to Submit Improvement Activities on Behalfof During the CY 2025 Performance
Period b
# of Subgroups to Submit Improvement Activities in MVPs During the CY 2025 Performance
eriod c
29,017
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attesting that certain activities were
performed in the form and manner
specified by CMS with a set of
authenticated credentials. Therefore, we
estimate an annual burden of 3,190
hours (38,433 respondents × 0.083 hr/
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20
response) at a cost of $339,748 (38,433
respondents × $8.84/response) for the
CY 2025 performance period/2027 MIPS
payment year.
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In Table 115, we continue to estimate
that the time required per response per
individual or group is 5 minutes or
0.083 hours for a computer system
analyst at a labor rate of $106.54/hr to
submit by logging in and manually
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62147
TABLE 115: Estimated Burden for Improvement Activities Data Submission
Burden and Respondent Descriptions
Burden Estimate
Total# of Respondents (Groups, Subgroups, Virtual Groups, and Individual Clinicians) to
Submit Improvement Activities Data on Behalf of Clinicians During the CY 2025
Performance Period a
Total Annual Hours Per Respondent (b)
As shown in Table 116, using our
unchanged currently approved per
respondent burden estimate, the
decrease in the number of respondents
results in an adjustment of ¥984 hours
and ¥$104,807 for the CY 2025
38,433
0.083
performance period/2027 MIPS
payment year.
TABLE 116: Change in Estimated Burden for Improvement Activities Submission
Burden and Respondent Descriptions
Burden Estimate
Total Currently Approved Annual Hours (a)
4,174
Total Annual Hours for Respondents in CY 2025 PFS Proposed Rule (b) (See Table
115 row c
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any new or revised requirements or
burden outside of providing CMS with
flexibility in how we communicate, we
are not proposing any changes to the
nomination of MVPs under that control
number.
k. ICRs Regarding the Cost Performance
Category (§ 414.1350)
The cost performance category relies
on administrative claims data. The
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 following proposals in
section IV.A.4.e.(2). of this proposed
rule would not result in the need to add
or revise or delete any claims data
fields: (1) add 6 new episode-based cost
measures; (2) modify 2 existing episodebased measures; (3) update the
operational list of care episode and
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j. ICRs Regarding the Nomination of
MVPs
In section IV.A.4.a.(2) of this
proposed rule, we are proposing a
modification to the MVP maintenance
webinar process previously finalized in
the CY 2022 PFS final rule (86 FR
65410) and modified in the CY 2023
PFS final rule (87 FR 70037).
Specifically, we are proposing to modify
the MVP maintenance webinar process
to provide us more flexibility in how we
communicate submitted maintenance
recommendations prior to proposing
them formally in rulemaking. We
believe this flexibility in
communicating recommendations
through alternative webinar formats or
other public communication channels
would offer similar opportunities for
public review and feedback as a live
public webinar. As this proposal would
not require additional steps to the MVP
nomination process described in the CY
2021 PFS final rule (85 FR 84990 and
84991), we are continuing our currently
approved 12 hours per response burden
estimate for the CY 2025 performance
period/2027 MIPS payment year. We
refer readers to section VII.E.17.e.(2)(d).
of this proposed rule where we discuss
our impact analysis for this proposal.
The requirements and burden for the
nomination of MVPs are currently
approved by OMB under control
number 0938–1314 (CMS–10621). Since
the proposed change does not set out
EP31JY24.155
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i. ICRs Regarding the Nomination of
Improvement Activities (§ 414.1360)
In this rulemaking, we are not
proposing any new or revised collection
of information requirements or burden
related to the Nomination of
Improvement Activities for the CY 2025
performance period/2027 MIPS
payment year. 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
Nomination of Improvement Activities
under that control number.
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patient condition groups and codes to
reflect new and modified measures we
are proposing; (4) and adopt criteria to
specify objective bases for the removal
of any cost measures from the MIPS cost
performance category. Consequently, we
are not proposing any changes under the
aforementioned control number. We
refer readers to section IV.A.4.e.(2).for
details on these proposals.
l. ICRs Regarding Partial QP Elections
(§§ 414.1310(b) and 414.1430)
We are not proposing any new or
revised collection of information
requirements or related to the Partial QP
Elections to participate in MIPS as a
MIPS eligible clinician in the CY 2025
performance period/2027 MIPS
payment year. In this section of this
proposed rule, we identify proposed
adjustments to the estimated burden for
partial QP elections that will be
submitted to OMB for review under
control number 0938–1314 (CMS–
10621), as summarized in Tables 78 and
79. These proposed adjustments to
estimated burden for the CY 2025
performance period/2027 MIPS
payment year are due to the availability
of updated data, rather than proposed
policies or statute changes in section
IV.A.4. of this proposed rule.
Based on the number of QP elections
submitted for the CY 2023 performance
period/2025 MIPS payment year, we
estimate in this proposed rule that we
will receive a total of 18 partial QP
elections from 18 APM respondents
(representing 333 distinct national
provider identifiers (NPIs) and 363
distinct TIN/NPIs). We do not estimate
any partial QP elections at the eligible
clinician level, as no individual eligible
clinicians elected to report as partial
QPs for the CY 2023 performance
period/2025 MIPS payment year. This
estimate is a decrease of 269
submissions from the currently
approved estimate of 287 (87 FR 70167
and 70168). We continue to estimate it
will take 0.25 hours for a computer
system analyst or equivalent to
complete and submit the election
process.
In Table 117, we estimate an annual
burden of 5 hours (18 responses × 0.25
hr/response) at a cost of $480 (18
responses × $26.64/response) for the CY
2025 performance period/2027 MIPS
payment year.
TABLE 117: Estimated Burden for Partial QP Elections
Burden and Respondent Descriptions
Burden Estimate
Total Annual Hours per Other Payer Arrangement (b)
In Table 118, we illustrate the net
change in estimated burden for the
Partial QP Election Process using the
currently approved burden in the CY
2023 PFS final rule (87 FR 70167 and
70168). In aggregate, the estimated
change in responses will result in an
adjustment of ¥67 hours and ¥$7,166
for the CY 2025 performance period/
2027 MIPS payment year.
TABLE 118: Change in Estimated Burden for Partial QP Elections
Burden and Respondent Descriptions
Burden Estimate
Total Current! A roved Annual Hours for Res ondents a
Total Annual Hours for Respondents in CY 2025 PFS Proposed Rule (b) (See
Table 117, row c )
72
5
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Total Current! A roved Annual Cost for Res ondents
Total Annual Cost for Respondents in CY 2025 PFS Proposed Rule (e) (See
Table 117, row e )
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
m. ICRs Regarding Other Payer
Advanced APM Determinations: PayerInitiated Process (§ 414.1445) and
Eligible Clinician-Initiated Process
(§ 414.1445)
In this section, we identify proposed
adjustments to the estimate burden for
ICRs regarding other payer advanced
APM determinations. These proposed
adjustments, summarized in Tables 78
and 79, reflect the availability of
updated data rather than proposed
policies or statutory requirements, and
will be submitted to OMB for review
under control number 0938–1314
(CMS–10621).
(1) Payer-Initiated Process (§ 414.1445)
We are not proposing any new or
revised collection of information
requirements related to the PayerInitiated Process for the CY 2025
performance period/2027 MIPS
payment year. Due to declining requests
in recent years, we are adjusting our
burden estimates for the CY 2025
performance period/2027 MIPS
payment year. In this proposed rule, we
estimate that we will receive 10
62149
submissions for the Payer-Initiated
Process for the CY 2025 performance
period/2027 MIPS payment year, a
decrease of 5 submissions from the
currently approved estimate of 15
responses (86 FR 65607 and 65608). We
continue to estimate it will take 10
hours for a computer system analyst per
arrangement.
In Table 119, we estimate an annual
burden of 100 hours (10 responses × 10
hr/response) at a cost of $10,654 (10
responses × $1,065.40/response) for the
CY 2025 performance period/2027 MIPS
payment year.
TABLE 119: Estimated Burden for Other Payer Advanced APM Identification
Determinations: Payer-Initiated Process
Burden and Respondent Descriptions
Burden Estimate
Total # of Other Payer Arrangements (2 Medicaid, 6 Medicare Advantage Organizations, 2
Remainin Other Pa ers a
Total Annual Hours per Other Payer Arrangement (b)
In Table 120, we illustrate the net
change in estimated burden for the
Payer-Initiated Process using the
currently approved responses in the CY
2022 PFS final rule (86 FR 65606 and
65607). In aggregate, the estimated
change in the number of responses will
result in an adjustment of ¥50 hours
and ¥$5,327 for the CY 2025
performance period/2027 MIPS
payment year.
TABLE 120: Change in Estimated Burden for Other Payer Advanced APM
Identification Determinations: Payer-Initiated Process
Burden and Respondent Descriptions
Burden Estimate
Total Currentl A roved Annual Hours for Res ondents a
Total Annual Hours for Respondents in CY 2025 PFS Proposed
Rule b See Table 1
150
100
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in recent years, we are adjusting our
burden estimates for the CY 2025
performance period/2027 MIPS
payment year. In this proposed rule, we
estimate that we will receive 10
submissions for the Eligible ClinicianInitiated Process for the CY 2025
performance period/2027 MIPS
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payment year, a decrease of 5
submissions from the currently
approved estimate of 15 (86 FR 65607
and 65608). We continue to estimate it
will take 10 hours for a computer
system analyst to complete and submit
the payment arrangement.
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(2) Eligible Clinician-Initiated Process
(§ 414.1445)
We are not proposing any new or
revised collection of information
requirements related to the Eligible
Clinician-Initiated Process for the CY
2025 performance period/2027 MIPS
payment year. Due to declining requests
EP31JY24.160
$15,981
$10,654
Total Annual Cost for Respondents in CY 2025 PFS Proposed Rule
e See Table 119, row e
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In Table 121, we estimate an annual
burden of 100 hours (10 responses × 10
hr/response) at a cost of $10,654 (10
responses × $1,065.40/response) for the
CY 2025 performance period/2027 MIPS
payment year.
TABLE 121: Estimated Burden for Other Payer Advanced APM Identification
Determinations: Eligible Clinician-Initiated Process
In Table 122, we illustrate the net
change in estimated burden for the
Eligible Clinician-Initiated Process
using the currently approved responses
in the CY 2022 PFS final rule (86 FR
65607 and 65608). In aggregate, the
estimated change in the number of
responses will result in an adjustment of
¥50 hours and ¥$5,327 for the CY
2025 performance period/2027 MIPS
payment year.
TABLE 122: Change in Estimated Burden for Other Payer Advanced APM
Identification Determinations: Clinician-Initiated Process
Burden and Respondent Descriptions
Burden Estimate
Total Currentl A roved Annual Hours for Res ondents a
Total Annual Hours for Respondents in CY 2025 PFS Proposed Rule (b) (See Table
121 row c
150
100
Rule (e) (
submissions from our currently
approved estimate of 551 in the CY 2020
PFS final rule (84 FR 63113 and 63114).
We continue to estimate it will take 5
hours for a medical or health systems to
prepare and submit an arrangement.
In Table 123, we estimate an annual
burden of 600 hours (120 responses × 5
hr/response) at a cost of $77,568 (120
responses × $646.40/response) for the
CY 2025 performance period/2027 MIPS
payment year.
EP31JY24.162
arrangements from outside parties.
Therefore, we are adjusting our
estimates downward for the CY 2025
performance period/2027 MIPS
payment year. In this proposed rule, we
estimate that 10 APM Entities, 100 TINs,
and 10 eligible clinicians will submit
data for QP determinations under the
All-Payer Combination Option in CY
2025 performance period/2027 MIPS
payment year. Our aggregated estimate
of 120 submissions is a decrease of 431
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(3) Submission of Data for QP
Determinations Under the All-Payer
Combination Option (§ 414.1440)
We are not proposing any new or
revised collection of information
requirements related to the Submission
of Data for QP Determinations under the
All-Payer Combination Option for the
CY 2025 performance period/2027 MIPS
payment year. In the past few years, we
have observed a significant drop in the
number of submissions from payment
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TABLE 123: Estimated Burden for the Submission of Data for AU-Payer QP
Determinations
Burden and Respondent Descriptions
Burden Estimate
Total# of APM Entities Submitting Data for All-Payer QP Determinations (a)
10
Total# ofTINs Submitting Data for All-Payer QP Determinations (b)
100
Total # of Eligible Clinicians Submitting Data for All-Payer QP Determinations (c)
In Table 124, we illustrate the net
change in estimated burden for the
submission of data for all-payer QP
determinations using the currently
approved responses in the CY 2020 PFS
final rule (84 FR 63113 and 63114). In
aggregate, the estimated change in the
number of responses will result in an
adjustment of ¥2,155 hours and
¥$278,598 for the CY 2025 performance
period/2027 MIPS payment year.
TABLE 124: Change in Estimated Burden for the Submission of Data for All-Payer QP
Determinations
Burden and Respondent Descriptions
Burden Estimate
Total Current! A roved Annual Hours for Res ondents a
Total Annual Hours for Respondents in CY 2025 PFS Proposed Rule (b) (See Table
123, row
2,755
600
':~1,,t~: ......·
Total Current!
Total Annual C
row h
es
u.t,,~~~.'.fjt,~&~ij1ifie'~··
; 11
C. Summary of Proposed Annual
Burden Estimates
Table 125 sets out the burden for this
rulemaking’s proposed provisions that
are subject to the PRA. It does not score
burden adjustments that are strictly
based on updated data and are unrelated
to any of the proposed provisions.
EP31JY24.164
period/2027 MIPS payment year. 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.
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n. ICRs Regarding Voluntary
Participants Election to Opt-Out of
Performance Data Display on Compare
Tools (§ 414.1395)
This rulemaking 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 for the CY 2025 performance
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TABLE 125: Annual Requirements and Burden Estimates
01\IB
01
-+-
t·
o t 11e
Control
, ,1
1>er
,. 1" .,11111
(C'1S ID
'lo.)
('L
§§ 414.1318, 414.1325, 414.1335,
14.1360, 414.1365, 414.1375,
14.1380, 414.1400, 414.1430,
14.1440, and 414.1445
uality Payment Program
'lo.
T
per Total \nnual Labor
1 \ nnua 1 Time
,
,
('
1,esponc
1ents R ota
1,esponse
1..1111e
ost
esponses
(hours) (hours)
(S/hr)
0938-1314
(CMS10621)
57,247
(56,981
clinicians
and groupslevel
T1Ns;218
APMs, 10
payers, 218
third part
intermediarie
s or entities
esponding t
calls for
nomination
§§ 427.402(c)(4) and (5), 428.302(c)(4) 0938-NEW
20
d (5), and 428.303(c)(4) and (5)
(CMSRegarding Rebate Reduction Requests
10858)
Submitted Under Sections 11101 and
11102 of the Inflation Reduction Act
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(35,357)
Varies
(78,366)
Varies
(9,000,834)
20
31
620
Varies
74,756
D. Submission of PRA-Related
Comments
respond to the comments in the
preamble to that document.
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
previously, please visit the CMS website
at https://www.cms.gov/regulationsand-guidance/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 sections of this
proposed rule and identify the rule
(CMS–1807–P), the ICR’s CFR citation,
and OMB control number.
VII. Regulatory Impact Analysis
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
this preamble, and, when we proceed
with a subsequent document, we will
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A. Statement of Need
In this proposed rule, we are
proposing payment and policy changes
under the Medicare PFS and changes to
implement amendments made under the
section 502 of the Further Continuing
Appropriations and Other Extensions
Act, 2024 (Pub. L. 118–22) (FCAOEA,
2024). Our proposed policies in this
rulemaking specifically address:
changes to the PFS; and 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 to the Quality
Payment Program (MIPS and Advanced
APMs); changes to payment policies for
drugs and biologicals products paid
under Medicare Part B, changes to the
Clinical Laboratory Fee Schedule
requirements, other changes to Medicare
Part B payment policies for Rural Health
Clinics and Federally Qualified Health
Centers, the Medicare coverage of
opioid use disorder services furnished
by opioid treatment programs and
coverage and payment for certain
preventive services; updates to
electronic prescribing for controlled
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T
('
ota 1 ost
S)
(
Sfmt 4702
substances for a covered Part D drug
under a prescription drug plan or an
MA–PD plan (section 2003 of the
SUPPORT Act); and proposed change to
the regulations associated with the
Ambulance Fee Schedule. 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. Clinical Laboratory Fee Schedule
(CLFS)—Proposed Revisions Consistent
With Recent Statutory Changes
In section III.F. of this proposed rule,
we propose the conforming regulations
text changes for CLFS data reporting
requirements due to the enactment of
section 502 of the Further Continuing
Appropriations and Other Extensions
Act, 2024 (Pub. L. 118–22) (FCAOEA,
2024). For clinical diagnostic laboratory
tests (CDLTs) that are not advanced
diagnostic laboratory tests (ADLTs),
section 502(b) of the FCAOEA, 2024
delayed the next data reporting period
by one year. Instead of taking place from
January 1, 2024, through March 31,
2024, data reporting will now take place
from January 1, 2025, through March 31,
2025, 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. Additionally, section 502(a) of the
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FCAOEA, 2024 amended the statutory
provisions for the phase-in of payment
reductions resulting from private payor
rate implementation to specify that the
applicable percent for CY 2024 is 0
percent, meaning that the payment
amount determined for a CDLT for CY
2024 shall not result in any reduction in
payment as compared to the payment
amount for that test for CY 2023.
Section 502(a) of the FCAOEA, 2024
further amended the statutory phase-in
provisions to provide that for CYs 2025
through 2027, 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.
b. Medicare Prescription Drug Inflation
Rebate Program
Section III.I. of this proposed rule
proposes regulations to implement
provisions of the Inflation Reduction
Act (IRA) that establish the Medicare
Prescription Drug Inflation Rebate
Program. Section 11101 of the IRA adds
new section 1847A(i) to the Act, which
establishes a requirement for
manufacturers to pay Medicare Part B
rebates for certain single source drugs
and biological products with prices that
increase faster than the rate of inflation,
beginning on January 1, 2023. Section
11102 of the IRA adds new section
1860D–14B to the Act, which
established a requirement for
manufacturers to pay Medicare Part D
rebates for certain Part D drugs and
biological products with prices that
increase faster than the rate of inflation,
beginning on October 1, 2022.
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c. Requirement for Electronic
Prescribing for Controlled Substances
for a Covered Part D Drug Under a
Prescription Drug Plan or an MA–PD
Plan
In section III.L. of this rulemaking, we
propose a change to the electronic
prescribing for controlled substances
(EPCS) requirement specified in
§ 423.160(a)(5) (referred to as the CMS
EPCS Program). The provision in
section III.L. of this proposed rule
proposes to revise § 423.160(a)(5) to
specify that prescriptions written for a
beneficiary in a long-term care (LTC)
facility would not be included in
determining CMS EPCS Program
compliance until January 1, 2028, and
that compliance actions against
prescribers who do not meet the
compliance threshold based on
prescriptions written for a beneficiary in
a LTC facility would commence on or
after January 1, 2028.
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d. Quality Payment Program
This proposed rule is also necessary
to make changes to the Quality Payment
Program to move the program forward to
focus more on measurement efforts,
refine how clinicians would 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 would
provide a better picture of clinicians’
performance.
2. Discretionary Provisions
a. Drugs and Biological Products Paid
Under Medicare Part B
In Section III.A.1. of this proposed
rule, as part of our continued
implementation of section 90004 of the
Infrastructure Investment and Jobs Act
(Pub. L. 117–58, 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 (hereinafter, refundable
drug), we are proposing a change in how
we would identify certain drugs that are
excluded from the definition of
refundable drug for those which
payment has been made under Part B for
fewer than 18 months; how we identify
drugs from a single-dose container; to
require the JW modifier if a billing
supplier is not administering a drug, but
there are discarded amounts during the
preparation process before supplying
the drug to the patient; and we discuss
an application received for increased
applicable percentage.
In section III.A.2 of this proposed
rule, we are proposing how payment
limits would be calculated when
manufacturers report negative or zero
ASP data to CMS. Generally, we are
proposing that negative and zero ASP
data be considered ‘‘not available’’
under section 1847A(c)(5)(B) of the Act
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and that positive ASP data be
considered available. In circumstances
in which negative or zero ASP data is
reported for some, but not all National
Drug Codes (NDCs) associated with a
billing and payment code for a drug, we
are proposing to calculate the payment
limit using only NDCs with positive
ASP data. In certain circumstances, we
are proposing to carryover the most
recent positive ASP data for the drug to
calculate a payment limit when the
manufacturer’s ASP is negative or zero.
For biosimilars with negative or zero
ASP data for all NDCs, we are proposing
to use positive ASP data from other
biosimilars with the same reference
product, when available, to calculate the
payment limit.
In section III.A.3. of this proposed
rule, we are proposing to clarify how
Medicare Administrative Contractors
(MACs) pay for radiopharmaceuticals
that are furnished in the physician’s
office. We are proposing to codify in
regulations at § 414.904(e)(6) that, for
radiopharmaceuticals furnished in a
setting other than the hospital
outpatient department, MACs shall
determine payment limits for
radiopharmaceuticals based on any
methodology used to determine
payment limits for
radiopharmaceuticals in place on or
prior to November 2003. Such
methodology may include, but is not
limited to, the use of invoice-based
pricing.
In section III.A.4. of this proposed
rule, we are proposing policies to
reduce barriers faced by beneficiaries
receiving immunosuppressive drugs
under the Medicare Part B
immunosuppressive drug benefit. That
is, we are proposing at § 410.30 to
include orally and enterally
administered compounded formulations
with active ingredients derived only
from FDA-approved drugs that have
approved immunosuppressive
indications or FDA-approved drugs that
have been determined by a MAC to be
reasonable and necessary for specific
purposes in immunosuppressive
treatment in the immunosuppressive
drug benefit. In addition, we are
proposing changes regarding supplying
fees and refills for immunosuppressive
drugs. These proposals include allowing
payment of a supply fee for a
prescription of a supply of up to 90 days
and allowing prescriptions for
immunosuppressive drugs to be
refillable.
In section III.A.5. of this proposed
rule, we are proposing to update
§ 410.63(b) to clarify existing CMS
policy that blood clotting factors must
be self-administered to be considered
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clotting factors for which the furnishing
fee applies. Additionally, we are
proposing to clarify at § 410.63(c) that
the furnishing fee is only available to
entities that furnish blood clotting
factors, unless the costs associated with
furnishing the clotting factor are paid
though another payment system,
including the PFS. That is, we are
proposing to clarify through revisions to
§ 410.63 that clotting factors (as
specified in section 1861(s)(2)(I) of the
Act) and those eligible to receive the
clotting factor furnishing fee (as
specified in section 1842(o)(5) of the
Act) are the same subset of products.
b. RHCs and FQHCs
In section III.B.2. of this proposed
rule, we are proposing several changes
to the furnishing of care coordination
services in RHCs and FQHCs. We are
proposing to require RHCs and FQHCs
to report the individual HCPCS codes
that make up the general care
management HCPCS code G0511 and to
utilize the same codes as those billing
under the PFS. RHCs and FQHCs would
no longer be required to report the
general care management HCPCS code
(G0511). We are also proposing to
permit billing of the add-on codes
associated with these services. In
addition, beginning in CY 2025, we are
proposing to adopt the coding and
policies regarding Advanced Primary
Care Management (APCM) services, as
discussed in section II.G of this
proposed rule.
For all of the care coordination
services, we are proposing to allow
separate payment at the national nonfacility PFS payment rate when the
individual code is on an RHC or FQHC
claim, either alone or with other payable
services. Payment rates would be
updated annually based on the PFS
amounts for these codes. We are also
seeking comment on how we can
improve the transparency and
predictability regarding which HCPCS
codes are considered care coordination
services to automate processes
downstream for RHCs and FQHCs.
In section III.B.3. of this proposed
rule, we are proposing the policy to
continue to adopt the definition
‘‘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, 2025, for
RHCs and FQHCs. We are also
proposing, on a temporary basis, to
allow payment for non-behavioral
health visits furnished via
telecommunication technology in a
manner that would closely align with
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the payment mechanisms mandated by
statute through December 31, 2024, that
is, RHCs and FQHCs would continue to
bill for RHC and FQHC services
furnished using telecommunication
technology services by reporting HCPCS
code G2025 on the claim through
December 31, 2025. In addition, we are
proposing to continue to delay the inperson visit requirement for mental
health services furnished via
communication technology by RHCs
and FQHCs to beneficiaries in their
homes until January 1, 2026.
In section III.B.4. of this proposed
rule, we discuss the implementation of
section 4124 of the CAA, 2023. Section
4124 of the CAA, 2023 established
Medicare coverage for intensive
outpatient program (IOP) services
furnished by a hospital to its
outpatients, or by a community mental
health center, a RHC or a FQHC, as a
distinct and organized intensive
ambulatory treatment service offering
less than 24-hour daily care in a
location other than an individual’s
home or inpatient or residential setting,
effective January 1, 2024 (88 FR 81838).
We are proposing to provide a payment
rate for 4 or more services per day in the
RHC and FQHC setting.
In section III.B.5. of this rulemaking,
we are proposing to allow RHCs and
FQHCs to bill for Part B preventive
vaccines and the administration at the
time of service. We propose that
payments for these claims will be made
according to Part B preventive vaccine
payment rates in other settings, to be
annually reconciled with the facilities’
actual vaccine costs on their cost
reports. Due to the operational systems
changes needed to facilitate payment
through claims, we propose that RHCs
and FQHCs begin billing for preventive
vaccines and their administration at the
time of service, for dates of service on
or after July 1, 2025.
In section III.B.6. of this proposed
rule, we discuss our proposal relating to
RHC productivity standards. We are
proposing to remove productivity
standards for RHCs.
In section III.B.7. of this proposed
rule, we discuss proposals relating to
the FQHC market basket. We are
proposing to rebase and revise the
FQHC PPS market basket to reflect a
2022 base year.
In section III.B.8. of this proposed
rule, we are clarifying that when RHCs
and FQHCs furnish dental services that
align with the inextricably linked
policies and operational requirements in
the physician setting, we would
consider those services to be a
qualifying visit and the RHC would be
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paid at the RHC AIR and the FQHC
would be paid under the FQHC PPS.
c. Modifications Related to Medicare
Coverage for Opioid Use Disorder (OUD)
Treatment Services Furnished by
Opioid Treatment Programs (OTPs)
In section III.F.2 of this proposed rule,
we are proposing telecommunication
flexibilities related to periodic
assessments and initiation of treatment
with methadone. We are proposing to
allow periodic assessments to be
furnished via audio-only
communications when two-way audiovideo communications technology is not
available to the beneficiary on a
permanent basis, to the extent that this
flexibility is authorized by SAMHSA
and DEA at the time the service is
furnished, and all other applicable
requirements are met. We believe that
making this current flexibility
permanent is appropriate, as it would
allow a beneficiary to decide with their
provider the best modality for receiving
care, and evidence has shown that
audio-only visits produce many of the
same benefits as video-based visits.790
Additionally, permanently extending
the flexibility to allow periodic
assessments to be furnished via audioonly communications would further
contribute towards health equity,
especially among Medicare beneficiaries
who are from underserved
populations.791 We are also proposing to
allow OTPs to use audio-visual
telecommunications for initiation of
treatment with methadone for any new
patient who will be treated by the OTP
with methadone if the OTP determines
that an adequate evaluation of the
patient can be accomplished via an
audio-visual telehealth platform. We
would allow the OTP intake add-on
code (HCPCS code G2076) to be paid for
two-way audio-video communications
technology when it is billed for the
initiation of treatment with methadone
to the extent that the use of audio-video
telecommunications technology to
initiate treatment with methadone is
authorized by DEA and SAMHSA at the
time the service is furnished, and all
other applicable requirements are met.
We believe this flexibility is needed to
align with new policy amendments
finalized by SAMHSA for initiation of
treatment with methadone at
§ 8.12(f)(2)(v)(A), and it would help
reduce barriers for many individuals
790 https://www.ncbi.nlm.nih.gov/pmc/articles/
PMC9446840.
791 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://
pubmed.ncbi.nlm.nih.gov/34534186/.
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beginning treatment with methadone
who often experience at least one barrier
to accessing treatment (for example,
reliable transportation, work schedule
conflicts, distance to treatment, etc.).792
In section III.F.3 of this proposed rule,
we are proposing payment updates to
intake activities (HCPCS code G2076)
furnished by OTPs in response to recent
regulatory reforms finalized by
SAMHSA at 42 CFR part 8 that aim to
recognize more patient-centered and
evidence-based paradigms of care for
OUD treatment (for example, harm
reduction interventions, recovery
support services, etc.). Specifically, we
are proposing to update the payment for
intake activities (HCPCS code G2076) to
include payment for social determinants
of health risk assessments (HCPCS code
G0136) in order to adequately reflect
additional effort for OTPs to identify a
patient’s unmet health-related social
needs (HRSNs), or the need and interest
for harm reduction interventions and
recovery support services that are
critical to the treatment of an OUD.
These would be consistent with new
revisions to standards for initial
assessment service activities required by
SAMHSA under § 8.12(f)(4)(i). CMS is
further requesting information to
understand how OTPs currently
coordinate care and make referrals to
community-based organizations (CBOs)
that address unmet HRSNs, provide
harm reduction services, and/or offer
recovery support services. Altogether,
we believe these proposals are necessary
to help OTPs address key issues during
initial assessments that may increase the
risk of a patient leaving OUD treatment
prematurely or that pose as barriers to
treatment engagement. For example,
patients with an OUD are more likely to
have lower educational attainment, be
food insecure, encounter financial
hardship, and housing instability, and
they often report financial and logistical
barriers (for example, lack of access to
transportation) as reasons for not
receiving treatment.793 However,
providers (including SUD treatment
facilities) who coordinate care with
CBOs, including peer support
organizations, housing agencies, and
educational and employment agencies,
to address unmet HRSNs (for example,
housing, transportation, etc.) identified
during assessments can positively
influence health outcomes and better
792 https://ascpjournal.biomedcentral.com/
articles/10.1186/s13722-022-00316-3.
793 https://www.sciencedirect.com/science/
article/pii/S1544319123000560?via%3Dihub.
https://www.sciencedirect.com/science/article/pii/
S0749379722001040?via%3Dihub.
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support a patient’s engagement in SUD
treatment.794
Furthermore, in section III.F.4 of this
proposed rule, we are proposing to
establish payment for new opioid
agonist and antagonist medications that
were recently approved by the FDA. We
would create a new add-on code to the
bundled payment to reflect take-home
supplies for nalmefene hydrochloride
(nalmefene) nasal spray (Opvee®),
which is indicated for the emergency
treatment of known or suspected opioid
overdose induced by natural or
synthetic opioids. The add-on code
would include payment for a carton of
two 2.7 mg nasal sprays of nalmefene
and overdose education furnished in
conjunction with distributing
nalmefene. We are also proposing
payment for a new extended-release
injectable buprenorphine product
(Brixadi®), indicated to treat moderate
to severe OUD and that comes in a
weekly (8 mg, 16 mg, 24 mg, 32 mg) and
monthly formulation (64 mg, 96 mg, and
128 mg). We would create a new weekly
bundled payment code (including both
a non-drug and drug component) for
weekly injectable buprenorphine to
reflect the weekly formulation of
Brixadi®. In addition, we are proposing
to update payment for the drug
component of the existing bundled
payment under the Medicare OTP
benefit for monthly injectable
buprenorphine (HCPCS G2069) in order
to reflect payment for the monthly
formulation of Brixadi®. We believe
these proposals are consistent with our
statutory authority under sections
1861(jjj)(1)(A) and 1834(w) of the Act,
which allow the Secretary to establish
Medicare bundled payment for opioid
agonist and antagonist treatment
medications that are approved by the
FDA. These proposals would expand
access to new opioid agonist and
antagonist medications that are
important to help prevent additional
opioid overdose deaths, reduce illicit
opioid use, and retain more individuals
with an OUD in treatment.795
Lastly, in section III.F.5 of this
proposed rule, we are clarifying a billing
requirement that an OUD diagnosis code
is required on claims submitted under
the Medicare OTP benefit for OUD
treatment services. This clarification is
needed to ensure payments made to
OTPs are in alignment with statutory
794 https://www.commonwealthfund.org/sites/
default/files/202209/ROI_calculator_evidence_
review_2022_update_Sept_2022.pdf; https://
aspe.hhs.gov/sites/default/files/private/pdf/260791/
BestSUD.pdf.
795 https://www.cdc.gov/drugoverdose/pdf/pubs/
2018-evidence-based-strategies.pdf; https://
pubmed.ncbi.nlm.nih.gov/24247147/.
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requirements under sections
1861(s)(2)(HH), 1861(jjj)(1), and 1834(w)
of the Act, which all specify that
services paid to OTPs under Medicare
Part B must be for the treatment of
opioid use disorder.
d. 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 value-based care
strategy of growth, alignment, and
equity, and to make changes that would
allow for timely improvements to
program policies and operations.
The proposed changes to the Shared
Savings Program include the following:
Proposed changes to the quality
performance standard and other quality
reporting requirements, including to (1)
require Shared Savings Program ACOs
to report the APP Plus quality measure
set that would incrementally grow to
comprise of 11 measures, consisting of
the 6 measures in the existing APP
quality measure set and 5 newly
proposed measures from the Adult
Universal Foundation measure set that
would be incrementally incorporated
into the APP Plus quality measure set
over performance years 2025 through
2028, (2) focus the collection types
available to Shared Savings Program
ACOs for reporting the APP Plus quality
measure set to all payer/all patient
eCQMs and Medicare CQMs, (3) require
Shared Savings Program ACOs that
report the APP Plus quality measure set,
to report on all measures in the APP
Plus quality measure set, as applicable,
(4) establish a Complex Organization
Adjustment for Virtual Groups and APM
Entities, including Shared Savings
Program ACOs, when reporting eCQMs,
(5) score Medicare CQMs using flat
benchmarks in their first 2 performance
periods in MIPS, and (6) extend the
eCQM reporting incentive in order to
promote the adoption of eCQMs.
Proposed changes to establish a new
‘‘prepaid shared savings’’ option to
assist eligible ACOs, with a history of
earning shared savings, with cash flow
and encourage investments that would
provide additional services for
beneficiaries, and proposed refinements
to recently-established advance
investment payment policies.
Proposed modifications to the Shared
Savings Program’s financial
methodology including to (1) ensure the
benchmarking methodology includes
sufficient incentive for ACOs providing
care to underserved communities to
enter and remain in the program
through the application of a proposed
health equity benchmark adjustment, (2)
specify a calculation methodology to
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account for the impact of improper
payments in recalculating expenditures
and payment amounts used in Shared
Savings Program financial calculations,
upon reopening a payment
determination pursuant to § 425.315(a),
(3) establish a methodology for
excluding payment amounts for HCPCS
and CPT codes exhibiting significant,
anomalous, and highly suspect (SAHS)
billing activity during CY 2024 or
subsequent calendar years that warrant
adjustment, and (4) technical changes
for consistency and clarity in provisions
of the Shared Savings Program
regulations on financial calculations, to
align and clarify the language we used
to describe weights applied to the
growth in ACO and regional risk scores
for each Medicare enrollment type, as
part of the calculation for capping ACO
and regional risk score growth,
respectively.
Proposed changes to other
programmatic areas, including: a
proposal in connection with the Shared
Savings Program compliance
requirements to permit continued
participation by ACOs whose number of
assigned beneficiaries falls below 5,000
during their agreement period; proposed
updates to provisions of the Shared
Savings Program regulations on
application procedures to reflect the
latest approach Antitrust Agencies use
to evaluate ACOs and enforce antitrust
measures; proposed updates to the
beneficiary assignment methodology
including to (1) revise the definition of
primary care services to align with
payment policy proposals and include,
among other services for the purposes of
beneficiary assignment, Safety Planning
Interventions, Post-Discharge
Telephonic Follow-up Contacts
Intervention, Virtual Check-in Services,
Advanced Primary Care Management
Services, Cardiovascular Risk
Assessment and Risk Management
Services, Interprofessional Consultation
Services, Direct Care Caregiver Training
Services, and Individual Behavior
Management/Modification Caregiver
Training Services, and (2) broaden the
existing exception to the program’s
voluntary alignment policy to allow for
additional beneficiaries to be claimsbased assigned to entities participating
in certain disease- or condition-specific
Innovation Center ACO models; and
proposed modifications to the
beneficiary notification requirements.
e. Medicare Part B Payment for
Preventive Services
Section III.H.1 of this proposed rule
outlines the implementation of policies
that impact the payment amount for
administration of preventive vaccines
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paid under the Part B vaccine benefit, as
well COVID–19 monoclonal antibodies
and the in-home additional payment for
Part B vaccine administration. These
provisions are necessary to provide
stable payment for preventive vaccine
administration and related policies, and
to allow predictability for providers and
suppliers to rely on for building and
sustaining robust vaccination programs.
Section III.H.2 of this proposed rule
addresses two items related to payment
for hepatitis B vaccine administration
under Part B. In section III.M. of this
proposed rule, we propose to expand
coverage of hepatitis B vaccinations by
revising existing regulations. If that
coverage expansion of hepatitis B
vaccines under Part B is finalized, we
would clarify that a physician’s order is
no longer required for the
administration of a hepatitis B vaccine
in Part B, which will facilitate roster
billing by mass immunizers for hepatitis
B vaccine administration. We are also
proposing that payment for hepatitis B
vaccines and their administration be
made at 100 percent of reasonable cost
in RHCs and FQHCs, separate from the
FQHC PPS or the RHC All-Inclusive
Rate (AIR) methodology, to streamline
payment for all Part B vaccines in those
settings.
In section III.H.3. of this proposed
rule, we are proposing a fee schedule for
Drugs Covered as Additional Preventive
Services (DCAPS), per section
1833(a)(1)(W)(ii) of the Act. We propose
to determine payment limits for DCAPS
drugs based on the ASP payment
methodology set forth under section
1847A of the Act if possible, and we
propose alternative payment mechanism
for calculating payment limits for
DCAPS drugs if ASP data is not
available. We also propose payment
limits for supplying and administration
fees for DCAPS drugs that are similar to
those fees for drugs paid under the ASP
payment methodology set forth under
section 1847A of the Act. Finally, we
propose to determine payment limits for
DCAPS drugs in RHCs and FQHCs, and
any supply and administration fee,
using this same fee schedule, and to pay
for DCAPS drugs and their
administration on a claim-by-claim
basis.
f. Expand Colorectal Cancer Screening
In section III.K. of this rulemaking, we
propose to update and expand coverage
for CRC screening by (1) removing
coverage for the barium enema
procedure in regulations at § 410.37, (2)
adding coverage for the CTC procedure
in regulations at § 410.37, and (3)
expanding a ‘‘complete colorectal
cancer screening’’ in § 410.37(k) to
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include a follow-on screening
colonoscopy after a Medicare covered
blood-based biomarker CRC screening
test (described and authorized in NCD
210.3) returns a positive result. The
Center for Disease Control and
Prevention (CDC) describes CRC as ‘‘a
disease in which cells in the colon or
rectum grow out of control . . .
Sometimes abnormal growths, called
polyps, form in the colon or rectum.
Over time, some polyps may turn into
cancer. Screening tests can find polyps
so they can be removed before turning
into cancer. Screening also helps find
colorectal cancer at an early stage, when
treatment works best.’’ 796 The National
Cancer Institute reports that CRC is the
fourth most common type of cancer and
estimates that the United States
experienced 153,020 new cases and
52,550 new deaths from CRC in 2023. In
addition, the rate of new cases and new
deaths from CRC is more common in
men than women and significantly
greater for those of African American
and Non-Hispanic American Indian/
Alaska Native descent compared to all
races.797
g. Expand Hepatitis B Vaccine Coverage
In section III.M. of this rulemaking,
we propose to expand Hepatitis B
vaccine coverage by revising our
regulatory definition for intermediate
risk groups by adding a new paragraph
to include individuals who have not
previously received a completed
hepatitis B vaccination series or whose
vaccination history is unknown
(§ 410.63(a)(2)). Hepatitis B is a vaccinepreventable liver disease caused by the
hepatitis B virus.798 The vaccine
consists of a series of typically 3 doses
delivered at various intervals.799
Hepatitis B virus is transmitted when
body fluid (blood, semen, or other) from
a person infected with the virus enters
the body of someone who is
uninfected.800 This can happen through
sexual contact; sharing needles,
syringes, or other drug-injection
equipment; transmission from the
gestational parent to baby during
pregnancy or at birth; direct contact
with blood or open sores; or sharing
796 CDC website: https://www.cdc.gov/cancer/
colorectal/basic_info/what-is-colorectal-cancer.htm.
797 NCI Website: https://seer.cancer.gov/statfacts/
html/colorect.html.
798 CDC, 2023. Hepatitis B surveillance 2021.
Retrieved from https://www.cdc.gov/hepatitis/
statistics/2021surveillance/hepatitis-b.htm.
799 CDC. Viral hepatitis. FAQ for health
professionals. Atlanta, GA: U.S. HHS, CDC; 2022.
Retrieved from https://www.cdc.gov/hepatitis/hbv/
hbvfaq.htm.
800 CDC, 2023. Hepatitis B surveillance 2021.
Retrieved from https://www.cdc.gov/hepatitis/
statistics/2021surveillance/hepatitis-b.htm.
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contaminated items such as
toothbrushes, razors or medical
equipment (such as a glucose monitor)
of a person who has hepatitis B.801
Hepatitis B can be an acute, short-term
illness and it can develop into a longterm, chronic infection. Chronic
hepatitis B can lead to serious health
problems, including cirrhosis, liver
cancer, and death. Treatments for
hepatitis B are available but no cure
exists. There are currently an estimated
2.4 million individuals in the U.S.
living with hepatitis B virus and an
estimated 20,000 new infections every
year.802 We believe our proposal will
help protect Medicare beneficiaries from
acquiring hepatitis B infection,
contribute to eliminating viral hepatitis
as a public health threat in the United
States and is in the best interest of the
Medicare program and its beneficiaries.
h. Medicare Parts A and B Overpayment
Provisions of the Affordable Care Act
(§ 401.305(b)(1) Through (3))
Section III.O. of this proposed rule
discusses existing § 401.305(b)(1),
which specifies when a person who has
received an overpayment must report
and return an overpayment. We propose
to amend this regulation to reference
revised § 401.305(b)(2) and new
§ 401.305(b)(3). We are proposing a
technical modification to the
introductory language in § 401.305(b)(2)
to acknowledge that this paragraph
might be applicable after the suspension
described in new § 401.305(b)(3) is
complete. New proposed § 401.305(b)(3)
would identify the circumstances under
which the deadline for reporting and
returning overpayments would be
suspended to allow time for providers to
investigate and calculate overpayments.
We do not have a basis for estimating
the impact associated with this
amendment. We solicit comment on the
analysis and conclusions provided in
the RIA.
B. Overall Impact
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We have examined the impacts of this
proposed 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
801 CDC. 2024. Viral Hepatitis FAQs for the
public. Retrieved from https://www.cdc.gov/
hepatitis/hbv/bfaq.htm.
802 Conners EE, Panagiotakopoulos L, Hofmeister
MG, et al. Screening and testing for hepatitis B virus
infection: CDC recommendations—United States,
2023. MMWR Recomm Rep. 2023;72(1):1–25.
Retrieved from https://www.cdc.gov/mmwr/
volumes/72/rr/rr7201a1.htm.
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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
(including potential economic,
environmental, public health and safety
effects, distributive impacts, and
equity). 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 the Office of
Information and Regulatory Affairs
(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
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62157
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.
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 suppliers, and
providers 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, Medicare payment is made
under the PFS 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
rulemaking will not have a significant
E:\FR\FM\31JYP2.SGM
31JYP2
62158
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
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 2024, that
threshold is approximately $183
million. This proposed rule will impose
no mandates on State, local, or tribal
governments or on the private sector.
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
rulemaking 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 proposed
rule, meets all assessment requirements.
The analysis explains the rationale for
and purposes of this proposed rule;
details the costs and benefits of this
rulemaking; 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 various 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 policy change 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 rulemaking describe
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 2024 with
payment rates for CY 2025 using CY
2023 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
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 2025, as
specified in section 1848(d)(19) of the
Act, is 0.00 percent before applying
other adjustments.
To calculate the estimated CY 2025
PFS conversion factor (CF), we took the
CY 2024 conversion factor without the
payment increase of 1.25 percent
provided by the CAA, 2023 that applied
to services furnished from January 1,
2024 through March 8, 2024, and the
2.93 percent payment increase provided
by the CAA, 2024 that replaced the
previous 1.25 percent increase and
applies to services furnished from
March 9, 2024 through December 31,
2024 and multiplied it by the budget
neutrality adjustment required as
described in the preceding paragraphs.
We estimate the CY 2025 PFS CF to be
32.3562 which reflects a 0.05 percent
positive budget neutrality adjustment
required 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 removal of the
temporary 2.93 percent payment
increase for services furnished from
March 9, 2024 through December 31,
2024, as provided in the CAA, 2024. We
estimate the CY 2025 anesthesia CF to
be 20.3340, reflecting the same overall
PFS adjustments with the addition of
anesthesia-specific PE and MP
adjustments.
TABLE 126: Calculation of the CY 2025 PFS Conversion Factor
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33.2875
32.3400
0.00 percent (1.0000)
0.05 percent (1.0005)
32.3562
Sfmt 4725
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31JYP2
EP31JY24.166
lotter on DSK11XQN23PROD with PROPOSALS2
CY 2024 Conversion Factor
Conversion Factor without the CAA, 2024 (2.93 Percent
Increase for CY 2024)
CY 2025 Statutorv Update Factor
CY 2025 RYU Budget Neutrality Adiustment
CY 2025 Conversion Factor
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Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
TABLE 127: Calculation of the CY 2025 Anesthesia Conversion Factor
lotter on DSK11XQN23PROD with PROPOSALS2
Table 128 shows the impact on PFS
payment for physicians’ services based
on the proposed policies included this
proposed rule. 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 128 (CY
2025 PFS Estimated Impact on Total
Allowed Charges by Specialty). The
following is an explanation of the
information represented in Table 128.
• 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
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20.7739
20.1826
0.00 percent (1.0000)
0.05 percent (1.0005)
0.70 percent (1.0070)
20.3340
2023 utilization and CY 2024 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 2025 impact on total
allowed charges of the changes in the
work RVUs, including the impact of
changes due to potentially misvalued
codes.
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• Column D (Impact of PE RVU
Changes): This column shows the
estimated CY 2025 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 2025 impact on total
allowed charges of the changes in the
MP RVUs.
• Column F (Combined Impact): This
column shows the estimated CY 2025
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.
BILLING CODE P
E:\FR\FM\31JYP2.SGM
31JYP2
EP31JY24.167
CY 2024 National Average Anesthesia Conversion Factor
Conversion Factor without the CAA, 2024 (2.93 Percent
Increase for CY 2024)
CY 2025 Statutory Update Factor
CY 2025 RVU Budget Neutrality Adjustment
CY 2025 Anesthesia Fee Schedule Practice Expense and
Malpractice Adjustment
CY 2025 Conversion Factor
62160
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
TABLE 128: CY 2025 PFS Estimated Impact on Total Allowed Charges by Specialty
Impact
(C)
of Work
Allowed
Charges
(mil)
I
I
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Impact
(D)
of PE
I
Impact
(E)
of MP
RYU
RYU
RYU
Changes
Changes
Changes
0%
1%
0%
0%
0%
0%
3%
3%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
-1%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
-1%
0%
0%
-1%
0%
0%
0%
0%
0%
0%
1%
0%
0%
0%
1%
1%
1%
1%
0%
0%
-2%
0%
1%
0%
0%
0%
0%
1%
0%
0%
0%
0%
0%
0%
-2%
0%
1%
0%
0%
0%
1%
0%
0%
-1%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
$207
$1,488
$70
$155
$5,748
$616
$680
$794
$143
$309
$3,717
$875
$2,240
$491
$5,133
$1,372
$341
$1,484
$193
$251
$1,501
$512
$513
$8,771
$792
$418
$142
$1,571
$1,252
$658
$47
$987
$6,531
$531
$4,469
$1,280
$57
$3,239
$54
$1,095
$1,090
$51
$1,054
Allergy/Immunology
Anesthesiology
Audiologist
Cardiac Surgery
Cardiology
Chiropractic
Clinical Psychologist
Clinical Social Worker
Colon And Rectal Surgery
Critical Care
Dennatolo2:v
Diagnostic Testing Facility
Emergency Medicine
Endocrinology
Family Practice
Gastroenterology
General Practice
General Surgery
Geriatrics
Hand Surgery
Hematology/Oncology
Independent Laboratory
Infectious Disease
Internal Medicine
lnterventional Pain Mgmt
lnterventional Radiology
Multispecialtv Clinic/Other Phys
Nephrology
Neurology
Neurosurgery
Nuclear Medicine
Nurse Anes/ Anes Asst
Nurse Practitioner
Obstetrics/Gynecology
Ophthalmology
Optometry
Oral/Maxillofacial Surgery
Orthopedic Surgery
Other
Otolarvngology
Pathology
Pediatrics
Physical Medicine
I
Sfmt 4725
E:\FR\FM\31JYP2.SGM
31JYP2
I
(F)
Combined
Impact
0%
2%
0%
0%
0%
1%
3%
4%
0%
1%
0%
-2%
0%
1%
1%
0%
0%
0%
1%
-1%
0%
0%
0%
1%
0%
-2%
0%
1%
0%
0%
0%
1%
0%
-1%
-1%
-1%
0%
-1%
0%
0%
0%
1%
0%
EP31JY24.168
(B)
(A)
Specialty
62161
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
I
I
Impact
(C)
of Work
RVlJ
Changes
I
Impact
(D)
of PE
RVlJ
Changes
Physical/Occupational Therapy
$5,607
0%
Physician Assistant
$3,472
0%
Plastic Surgery
$280
0%
Podiatry
$1,780
0%
Portable X-Ray Sunnlier
$69
0%
Psychiatry
$795
1%
Pulmonarv Disease
$1,188
0%
Radiation Oncology and Radiation Therapy
$1,458
Centers
0%
Radiology
$4,273
0%
Rheumatology
$496
0%
Thoracic Surgery
$277
0%
Urology
$1,532
0%
Vascular Surgery
$937
0%
$106,413
Total
0%
* Column F may not equal the sum of columns C, D, and E due to rounding.
lotter on DSK11XQN23PROD with PROPOSALS2
In recent years, we have received
requests from interested parties to
provide more granular information that
separates the specialty-specific impacts
by site of service. These interested
parties have presented us with highlevel information suggesting that
Medicare payment policies are directly
responsible for consolidating 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 healthcare delivery,
especially concerning independent
versus facility-based 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 the CY 2023 PFS final rule (87 FR
69429 through 69438). As part of our
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holistic review of how best to 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 2025 PFS proposed rule at https://
www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/
PhysicianFeeSched/PFS-FederalRegulation-Notices.html.
We provided an additional impact
table for this rulemaking cycle that
includes a facility/non-facility breakout
of payment changes. The following is an
explanation of the information
represented in Table 129.
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I
Impact
(E)
of MP
RYU
Changes
I
(F)
Combined
Impact
0%
0%
0%
0%
1%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
-1%
0%
1%
1%
1%
0%
0%
0%
0%
-1%
-2%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
-1%
-2%
0%
• 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
2023 utilization and CY 2024 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 2025
combined impact on total allowed
charges.
E:\FR\FM\31JYP2.SGM
31JYP2
EP31JY24.169
(B)
Allowed
Charges
(mil)
(A)
Specialty
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TABLE 129: CY 2025 PFS Estimated Impact on Total Allowed Charges by Setting
Allergy/Immunology
Anesthesiology
Audiologist
Cardiac Surgery
Cardiology
0%
0%
Chiropractic
1%
Clinical Psychologist
Clinical Social Worker
Colon And Rectal Surgery
Critical Care
•• >
'ro}Ji, •••••
1%
·
0%
$3,580
0%
$137
0%
Diagnostic Testing Facility
Emergency Medicine
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E:\FR\FM\31JYP2.SGM
31JYP2
EP31JY24.170
lotter on DSK11XQN23PROD with PROPOSALS2
Dermatology
$259
f.3111
62163
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
. . (;\:)· ..•. ·.•.
•• • • • Specialty •
.•
.> .. (B)
> .
(C) · • · ... (0) ..• • ••.· .
•• • Total:.Norl~ •• .· <. Allowed, .· Combined '.
Paci.lity/Facility
• •\ Charges.
·• •
.. •.... ·.· . . .
(rni)J ..
. ·..
Rndocrinology
Family Practice
Non-Facilitv
$186
0%
Facilitv
$2,054
0%
Non-Facilitv
$395
1%
Facility
$96
0%
Non-Facility
$4 131
1%
002
0%
Facilitv
Gastroenterology
General Practice
General Surgery
impact
$1
Non-Facility
$505
1%
Facilitv
$868
0%
Non-Facilitv
$273
0%
Facility
$68
0%
Non-Facility
$438
0%
Facilit)I
..
$1,045
0%
\'.'
1%',
1%
'·$193 ...
Geriatrics
Hand Surgery
Hematology/Oncology
Independent Laboratory
Infectious Disease
lotter on DSK11XQN23PROD with PROPOSALS2
Internal Medicine
Intcrvcntional Pain Mgmt
Non-Facility
$125
Facilit:v
$68
0%
$25l
. ,J¾
Non-Facilitv
$134
0%
Facilitv
$116
$l;SOJ
·o¾.
$976
-1%
Facility
$525
0%
Non-Facility
$499
0%
Facilitv
$13
0%
. TOTAL.
• ··••· $513 .\
Non-Facilitv
$81
.0%
0%
Facility
TOTAL
$432
$8,771
Non-Facility
$4,373
Facilitv
$4,397
TOTAL
$792
$624
Facilitv
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TOTAL
Fmt 4701
Sfmt 4725
-3%
Non-Facilitv
Non-Facility
Jnterventional Radiology
..
E:\FR\FM\31JYP2.SGM
$168
$418
31JYP2
•
0%
1%
1%
0%
0%
0%
1%
-2%
EP31JY24.171
..
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
•.
. .(A)
...·.·. (C) ..·• ........ (D) . ••··
• Total: Non- •• .·•· Allowed
Combined .
Facflity/Facility . . •· Charges · • Imp~c(i •
·~mil) ··t ••
·•·.· .. ·.· . .(B) ·.··• .. ·•••···•·
.Specialty .• •
i.
Multispecialty Clinic/Other Phys
Nephrology
Non-Facilitv
$259
-3%
Facilitv
$159
1%
Non-Facilitv
$71
0%
Facilitv
$71
0%
Non-Facility
$934
1%
Facilitv
$636
0%
1--__:_1\'-'ro:.:.:n:__:-F:__:a::.:c:..::il:..::itvL___ _j__----=c$-=-80.:..:8=-----1-----=0-'--%.:__------l
Neurology
Facilitv
1---__:_1\'-'ro:.:. ,n:__:-F:__:a::.:c:..::il:..::it'.Lv,_-+_
Neurosurgery
Nuclear Medicine
Nurse Anes/ Anes Asst
Nurse Practitioner
Obstetrics/Gynecology
Ophthalmology
Optometry
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Oral/Maxillofacial Surgery
Orthopedic Surgery
Other
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$444
0%
.:..:15=----+----=0-'--%.:__------1
_.,,$_,_1
Facility
$543
0%
Non-Facility
$22
-1%
Facilitv
$24
1%
Non-Facilitv
$20
1%
Facilitv
$968
1%
Non-Facilitv
$4 295
0%
Facilitv
$2,236
0%
Non-Facilitv
$364
-1%
Facility
$167
0%
Non-Facilitv
$3,153
-2%
Facilitv
$1 315
-1%
Non-Facililv
$1,223
-1%
Facility
$56
0%
TOTAL
$57
0%
Non-Facility
$46
0%
Facilitv
$11
1%
TOTAL
$3,239
-1%
Non-Facilitv
$1,4?4
0%
Facilitv
$1,815
-2%
TOTAL
$54
0%
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31JYP2
EP31JY24.172
62164
Otolaryngology
Pathology
Pediatrics
Physical Medicine
Physical/Occupational Therapy
Physician Assistant
Plastic Surgery
Podiatry
Portable X-Ray Supplier
Psychiatry
Non-Facility
$43
0%
Facility
$11
1%
Non-Facility
$874
1%
Facility
$221
0%
Non-Facility
$583
0%
Facility
$507
0%
Non-Facility
$32
0%
Facility
$18
1%
Non-Facilitv
$520
0%
Facilitv
$534
0%
Nun-Facility
$5,607
0%
FacilitJi
$
4%
Non-Facility
$2,389
0%
Facilitv
$1,083
0%
Non-Facilitv
$127
Facilitv
$153
-1%
-1%
Non-Facilitv
$1,586
0%
Facilitv
$195
0%
Non-Facility
$67
1%
Facility
$3
1%
Non-Facility
$466
1%
Facilitv
Non-Facilitv
$329
$1,188
$523
1%
1%
1%
Facility
$665
0%
T01Al
$1,458
Non-Facility
$1,002
0%
-1%
Facilitv
$457
$4,273
2%
0%
TOTAL
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Radiation Oncology and Radiation Therapy Centers
Radiology
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Rheumatology
Thoracic Surgery
Urology
Vascular Surgery
BILLING CODE C
2. CY 2025 PFS Impact Discussion
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a. Changes in RVUs
The most widespread specialty-level
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 clinical social workers and
clinical psychologists, geriatrics,
anesthesiology, and nurse anesthetists,
psychiatry, and family practice, reflect
increases relative to other specialties.
These increases can largely be attributed
to the Year 4 update to clinical labor
pricing and/or the proposed
adjustments to transfer of postoperative
care for global surgical procedures.
These increases are also due to increases
in values 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
supply and equipment pricing updates.
The estimated impacts for several
specialties, including diagnostic testing
facilities, vascular surgery,
interventional radiology,
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ophthalmology, and orthopedic surgery,
reflect decreases in payments relative to
payment to other specialties, largely
resulting from the redistributive effects
of the implementation of the Year 4
update to clinical labor pricing and/or
the proposed adjustments to transfer of
postoperative care for global surgical
procedures. The services furnished by
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
4 clinical labor pricing under budget
neutrality. These decreases are also due
to the revaluation of individual
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 supply and equipment pricing
updates. The estimated impacts also
reflect decreases due to the 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
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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 128),
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 128 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 the specialty, and compared
to the same summed total from the
previous calendar year. Therefore, they
are averages and may not necessarily
represent what is happening to the
particular services furnished by a single
practitioner within any given specialty.
As discussed previously, we have
reviewed our suite of public use files
and have worked on new ways to offer
interested parties additional information
that addresses concerns about the lack
of granularity in our impact tables. To
illustrate how impacts can vary within
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specialties, we created a public use file
that models the expected percentage
change in total RVUs per practitioner.
Using CY 2023 utilization data, Total
RVUs change between ¥1 percent and
1 percent for more than 80 percent of
practitioners, representing
approximately 75 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 128 (CY 2025 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 98 percent of
these practitioners will experience a
change in Total RVUs between ¥1
percent and 1 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 128 indicates a 1 percent increase
in RVUs for the physical/occupational
therapy specialty as a whole; however,
24 percent of physical/occupational
therapy specialty practitioners—
representing over 21 percent of Total
RVUs for the specialty—will experience
a 1 percent or more increase in Total
RVUs. Meanwhile, 13 percent of
physical/occupational therapy specialty
practitioners will experience 1 percent
or more decreases in Total RVUs, and
these practitioners account for 14
percent 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 (see https://
www.cms.gov/medicare/payment/
prospective-payment-systems/hospitaloutpatient/addendum-a-b-updates).
The specialty impacts displayed in
Table 128 reflect changes within the
pool of total RVUs. The specialty
impacts table, therefore, includes any
changes in spending that result from
finalized policies that are subject to the
statutory budget neutrality requirement
at section 1848(c)(2)(B)(ii)(II) (such as
the updated proposals associated with
the transfer of postoperative care for
global surgical procedures in CY 2025 or
the clinical labor pricing update phasein that began in CY 2022) but does not
include any changes in spending which
result from finalized policies that are
not subject to the statutory budget
neutrality adjustment, and therefore,
have a neutral impact across all
specialties. The 2.50 and 2.93 percent
temporary payment increases for CY
2023 and CY 2024, respectively, are
statutory changes that take place outside
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of BN, and therefore, are not captured in
the specialty impacts displayed in Table
128. Section 1848(t)(2)(C) specifies that
these temporary payment increases are
not to be taken into account in
determining fee schedules for
physicians’ services furnished in years
after the respective increases end. As
such, these temporary increases are not
subject to the PFS budget neutrality
adjustment.
b. Impact
Column F of Table 128 displays the
estimated CY 2025 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 2025 PFS
proposed rule website at https://
www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/
PhysicianFeeSched/. We selected these
procedures for the sake of illustration
from among the procedures most
commonly furnished by a broad
spectrum of specialties. The change in
both facility rates and 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/.
D. Impact of Changes Related to
Telehealth Services
We are proposing to add several codes
to the Medicare Telehealth Services List
on a provisional basis, including HCPCS
codes G0011, G0013, G0248, GCTD1–3,
and GCTB1–2, and CPT Codes 97550,
97551, 97552, 96202, and 96203. We are
proposing to maintain certain
Telecommunications technology-related
flexibilities through 2025, including that
we will continue to use a definition of
direct supervision that allows
‘‘immediate availability’’ of the
supervising practitioner using real-time
audio and video interactive
telecommunications. We are also
proposing to delay implementation of
the telehealth frequency limitations for
subsequent nursing facility and
inpatient hospital visits for an
additional year, to include two-way,
real-time audio-only communication
technology for any telehealth service
furnished to a beneficiary in their home,
and to continue to permit the distant
site practitioner to use their currently
enrolled practice location instead of
their home address when providing
telehealth services from their home.
While we note that certain other
Medicare telehealth flexibilities related
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to the PHE for COVID–19 are expiring,
including the removal of statutory
geographic and location limitations for
most Medicare telehealth services, the
beneficiary’s home continues to be a
permissible originating site for certain
types of services including those
furnished for the diagnosis, evaluation,
or treatment of a mental health disorder,
including a Substance Use Disorder
(SUD), and for monthly End Stage Renal
Disease (ESRD) related clinical
assessments described in section
1881(b)(3)(B). However, expiration of
certain flexibilities for Medicare
telehealth services is not expected to
impact broader utilization of these
services because reasonable and
necessary services for the diagnosis or
treatment of an illness or injury
continue to be covered. Please see our
request for comment in section II.E. of
this proposed rule with regard to what
impact, if any, the expiration of the
current flexibilities would be expected
to have on overall service utilization for
CY 2025. Despite the fact that some
services will no longer be furnished
under telehealth, we expect that they
will continue to be furnished in-person.
We therefore anticipate that our
proposed provisions will result in
continued utilization of services that
can be furnished as Medicare telehealth
services during CY 2025 at levels
comparable to observed utilization of
these services during CY 2024.
E. Other Provisions of the Regulation
1. Impact of Proposals for Medicare
Parts A and B Payment for Dental
Services Inextricably Linked to Specific
Covered Medical Services
In section II.J.2. of this proposed rule,
we are proposing to add to the list in
§ 411.15(i)(3)(i) of clinical scenarios
under which FFS Medicare payment
may be made for dental services
inextricably linked to covered services
to now include certain dental services
associated with dialysis services for
beneficiaries with end-stage renal
disease (ESRD). Specifically, we are
proposing that Medicare Parts A and B
payment may be made for dental or oral
examination performed as part of a
comprehensive workup prior to
Medicare-covered dialysis services
when used in the treatment of ESRD;
and medically necessary diagnostic and
treatment services to eliminate an oral
or dental infection prior to, or
contemporaneously with covered
dialysis services in the treatment of
ESRD. By proposing to provide payment
for these dental services, we would
respond to the interested parties’
request that we focus on the ESRD
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patient population. We are also
soliciting comment on the potential
connection between dental services and
covered services used in the treatment
of diabetes as well as covered services
for individuals with sickle cell disease,
hemophilia, or autoimmune diseases
receiving immunosuppressive therapies.
We do not anticipate any significant
increase in utilization or payment
impact for additional dental services
given the historically low utilization of
these therapies.
Based on the Renal Management
Information System (REMIS) and
Enrollment Data Base (EDB) gathered
from the Integrated Data Repository
(IDR) we estimate Fee-For-Service (FFS)
Part B ESRD enrollment to have
averaged roughly 240 thousand
enrollees during CY 2023. Based on
United States Renal Data System
(USRDS) from the NIH, we estimate that
roughly 40,000 of these enrollees are on
the kidney transplant waitlist in any
given year and that roughly 10,000 of
these patients on the waitlist would
typically receive a transplant. Since we
already include dental services
associated with kidney transplant
patients in § 411.15(i)(3)(i)(A) as an
example of services for which payment
can be made for certain dental services,
we removed these patients from the
estimate, which left roughly 30,000 FFS
beneficiaries.
For a variety of reasons outlined
previously, we have historically
observed low FFS dental utilization in
instances when coverage could apply
(<1 percent of potential users). FFS
dental billing patterns have shown a
cost per covered utilizer of about $525
in recent years. To illustrate the
potential cost of the proposed payment
for dental services inextricably linked to
dialysis services for beneficiaries with
ESRD we applied three scenarios of
utilization (0.1 percent, 1 percent, 3
percent) and cost per patient of
approximately $525 to the 30,000
patients. Under all of these scenarios the
policy is projected to represent a
negligible cost to the Medicare program
(<$1,000,000) in any given year.
Therefore, we do not anticipate a
significant payment impact for these
provisions. It is important to note that
there is some uncertainty in these takeup rate assumptions, but they are
consistent with the current utilization of
dental services, including after the
regulation changes made in the CYs
2023 and 2024 PFS final rules.
Additionally, given that our proposed
addition to the list of clinical scenarios
under which payment may be made for
dental services inextricably linked to
covered services is not a change in
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coverage or payment policy, the cost
impact of this proposal is negligible and
therefore it is not necessary to adjust the
conversion factor under the PFS budget
neutrality requirement.
2. Impact of Proposed Changes Related
to Supervision of Outpatient Therapy
Services in Private Practices
As discussed in section II.H. of this
proposed rule, we are proposing to
change our regulatory requirements for
OTs and PTs who are enrolled as
suppliers in Medicare as OTs and PTs
in private practice (OTPPs and PTPPs,
respectively) to allow for general
supervision of their occupational
therapy assistants (OTAs) and physical
therapist assistants (PTAs) to the extent
permitted under State law. The
requirement for OTPPs and PTPPs to
provide direct supervision of OTAs and
PTAs, which has been in place since
2005, requires the OTPP/PTPP to be
present in the office suite or in the
patient’s home, and immediately
available to furnish assistance and
direction throughout the performance of
the procedure performed by the OTA/
PTA (or by an OT or PT they are
supervising who is not enrolled in
Medicare as a supplier). In contrast, the
proposal to allow for general
supervision would mean that the
procedure is furnished under the
OTPP’s/PTPP’s overall direction and
control, but the OTPP/PTPP need not be
present in the treatment location or
immediately available.
Should we finalize this proposal, we
believe that the change to allow for
general supervision of OTAs/PTAs by
OTPPs and PTPPs will have a positive
impact on patient access to outpatient
therapy services; and will align with the
currently required general supervision
of PTAs/OTAs by PTs and OTs who
work for Medicare institutional
providers, such as rehabilitation
agencies, outpatient hospitals, and
SNFs. It would also reflect the
supervision level specified in 44 State
physical therapy practice acts 803 and all
but one State occupational therapy
practice act.
3. Impacts of Proposed Changes Related
to Advanced Primary Care Management
Services
In section II.G.2 of this proposed rule,
‘‘Advanced Primary Care Management
(APCM) Services,’’ we are proposing to
create three HCPCS codes to use for
reporting the proposed APCM services
(HCPCS codes GPCM1, GPCM2, and
803 Federation of State Boards of Physical Therapy
Jurisdiction Licensure Reference Guide, https://
www.fsbpt.net/lrg/Home/
SupervisionRequirementLevelsBySetting.
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GPCM3) to recognize the resources
involved in furnishing services using an
advanced primary care delivery model
under the PFS. As described in sections
II.G.2.b and II.G.2.c of this proposed
rule, the proposed APCM services
incorporate elements of existing services
with the understanding that some
patients will require more resources and
some fewer based on variability in
patient complexity and needs. As we
ordinarily do, we are proposing to base
the PFS valuation for APCM codes on
the resources involved in furnishing the
typical case of the service which may
not necessarily reflect the actual
resources involved in furnishing every
individual service. To value APCM, we
compared the service elements
described by the proposed APCM codes
to the values we have established for the
specific care management services and
communication technology-based
services (CTBS) codes on which we
modeled the proposed service elements
of the APCM codes and which we built
into the service descriptors for GPCM1,
GPCM2, and GPCM3 (see also Table 129
and sections II.G.2.b. through II.G.2.d. of
this proposed rule). Specifically, the
proposed APCM services incorporate
elements of chronic care management
(CPT codes 99487, 99489, 99490, 99491,
99439, 99437), principal care
management (CPT codes 99424, 99425,
99426, 99427)), transitional care
management (CPT codes 99495 and
99496), interprofessional internet
consultation furnished by treating/
requesting practitioner (CPT code
99452), remote evaluation of patient
videos/images (HCPCS code G2250),
virtual check-ins (HCPCS code G2251
and G2252), and online digital E/M or
e-visits (CPT codes 98970, 98971,
98972, 99421, 99422, 99423) into this
new bundled PFS payment beginning
for CY 2025.
As discussed throughout section
II.G.2 of this proposed rule, we believe
that the proposed elements of APCM
services reflect the comprehensive
approach to care management involved
in care delivery using the advanced
primary care model. This is a model of
primary care that is being integrated
into current medical practice. As such,
we believe that it would be appropriate
to use the current valuation and uptake
of the codes on which we modeled the
APCM codes to inform our valuation of
APCM services. Using Medicare FFS
claims data and evidence from the CMS
Innovation Center’s testing of a series of
advanced primary care models (see
discussion in section II.G.2.a.(1) of this
proposed rule), we sought to understand
how these different services have been
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used historically and relate that
information to the way we are thinking
about the service elements for APCM
and the valuation of the three APCM
code levels. As discussed in section
II.G.2.e. of this proposed rule, for
Medicare beneficiaries who receive care
management services during a year, the
non-complex CCM base code is billed
on average for five months and with
three add-on codes during those five
months. However, this does not account
for the care management services that
are provided beyond one time-based
billing interval and without reaching the
next; nor does it account for the
resources involved in maintaining
certain advanced primary care practice
capabilities and readiness, including
patient population monitoring and care
needs assessment, to fully furnish and
bill APCM services as is medically
reasonable and necessary for any
individual patient during any calendar
month. Finally, this does not account
for changes to utilization of APCM that
may occur as a result of the billing and
documentation requirements for APCM
services when compared to the current
coding and payment for care
management and CTBS services.
We are estimating a utilization of
approximately 300,000 claims for the
proposed HCPCS code GPCM1, 1.3
million claims for the proposed HCPCS
code GPCM2, and 400,000 claims for the
proposed HCPCS code GPCM3, and are
seeking comment on our assumptions.
To estimate utilization for GPCM1, we
first calculated an eligible GPCM1
population by estimating the number of
Medicare beneficiaries without multiple
chronic conditions who have an
established relationship with a primary
care provider using Welcome to
Medicare and Annual Wellness Visit
claims and estimating the uptake of
APCM Level 1 based on average uptake
of CCM/PCM/TCM in CY 2022 claims
data; then, we adjusted this estimate to
account for increased frequency of
billing (multiplied by 12 to account for
12 months of assumed practitioner
billing for the proposed APCM service).
To estimate utilization for GPCM2, we
first calculated estimated ratios to
represent the average utilization of
CCM/PCM/TCM services in the first
year of policy implementation
compared to CY 2022 claims; then, we
applied a reduced utilization ratio to CY
2022 claims for CPT codes 99490 and
99487 (10.4 percent) and multiplied by
the eligible GPCM2 population of
Medicare beneficiaries with multiple
chronic conditions who are non-QMB;
finally, as described for GPCM1, we
adjusted this estimate to account for
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increased frequency of billing (increase
from an average of five months of CCM
claims per beneficiary to 12 months of
assumed practitioner billing for the
proposed APCM service, or 237.3
percent). To estimate utilization for
GPCM3, we took the estimated number
of GPCM2 claims for CPT codes 99490
and 99487 and multiplied by the
eligible GPCM3 population of Medicare
beneficiaries with multiple chronic
conditions who are QMB; again, we
adjusted this estimate to account for
increased frequency of billing (same
percentage applied to GPCM2).
We anticipate that these proposed
coding and payment policies for APCM
services would result in slight
reductions in utilization of existing care
management and CTBS services during
CY 2025 when compared to observed
utilization of these services during CY
2024. Specifically, we are estimating an
approximate 11.4 percent reduction in
utilization from CY 2024 across the 20
service codes which are incorporated
into the APCM services (see previously).
The estimated total net increase is
approximately 700,000 claims, and we
do not anticipate a significant payment
impact for these provisions. We believe
that the cost impact of this proposal is
negligible and therefore it is not
necessary to adjust the conversion factor
under the PFS budget neutrality
requirement.
4. Impact of Proposed Changes Related
to Strategies for Improving Global
Surgery Payment Accuracy
In section II.G.5 of this proposed rule,
‘‘Strategies for Improving Global
Surgery Payment Accuracy,’’ we discuss
our current policy to require the use of
modifiers to help us identify and adjust
payment for a global package when
there is a formal transfer of care (that is,
a written agreement) between the
practitioner who furnishes the
procedure (proceduralist) and another
practitioner. The transfer of care
modifiers identify and adjust the global
package payment for cases where the
pre-operative, operative, and postoperative portions of the global package
are furnished by different practitioners.
We are proposing to require the use of
the appropriate transfer of care modifier
(modifier –54, –55, or –56) for all 90-day
global surgical packages in any case
when a practitioner (or another in the
same group practice) expects to furnish
only a portion of a global package
(including but not limited to when there
is a formal, documented transfer of care
as under current policy, or an informal,
non-documented but expected, transfer
of care. This could result in more
application of, and therefore more
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62169
impact on spending from the
appropriate usage of the transfer of care
modifiers (modifiers –54, –55, and –56).
As noted earlier, we are proposing to
require the use of the existing modifier
(–54) for all 90-day global surgical
packages in any case when a
practitioner (or group practice) expects
to furnish only the procedure portion of
a global package (including when there
is a formal, documented transfer of care
as under current policy). Since we
believe that this will result in expanded
use of the transfer of care modifiers,
which will have a corresponding effect
on the payment for the affected services,
we have reflected this in our utilization
estimates accordingly (see download file
for this proposed rule titled CY 2025
PFS final rule 2023 Utilization Data
Crosswalked to 2025 at https://
www.cms.gov/medicare/payment/feeschedules/physician/federal-regulationnotices?DLSort=2&DLEntries=10&
DLPage=1&DLSortDir=descending) and
anticipate more global surgical packages
and post-op care to be billed separately
using the modifiers, which could have
payment consequences for a selection of
high-volume global surgery codes. We
assume that the same number of global
surgery codes would be billed; however,
we anticipate more codes would be
billed using the transfer of care
modifiers. We do not expect the
utilization of separately billable postoperative E/M services would change.
Rather than modify our utilization
estimates for these codes, our utilization
estimate in this proposal includes only
90-day high volume and/or high-cost
procedure codes where reporting postoperative visits with CPT code 99024
(Postoperative follow-up visit, normally
included in the surgical package, to
indicate that an evaluation and
management service was performed
during a postoperative period for a
reason(s) related to the original
procedure) is required. This is a
relatively small set of codes
(approximately 180) versus the full
range of approximately 4,000 global
surgical codes; however, this subset of
codes accounts for about 73 percent of
total Medicare 90-day procedure
volume. The full list of affected codes is
available in the file titled ‘‘CY 2024
Analytic Crosswalk to CY 2025’’ on the
CMS website under downloads for the
CY 2025 PFS proposed rule at https://
www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/
PhysicianFeeSched/PFS-FederalRegulation-Notices.html.
For this select list of global surgical
codes, we are estimating that the
transfer of care modifier, modifier –54,
will be employed 20 percent of the time.
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We believe that this is a conservative
estimate given the frequency with
which these global surgical services
involve a transfer of postoperative care.
RAND’s research has indicated that a
post-operative transfer of care is
common for 90-day global surgical
procedures but that these transfers of
care are almost never reported with the
appropriate –54 or –55 modifiers. Then,
for the 20 percent of cases where we
believe the transfer of care modifier will
be employed, we are proposing to apply
the payment reduction associated with
the modifier –54 for postoperative care
and apply it to the utilization estimate
for the associated procedures billed
using the transfer of care modifiers.
These percentages can be found in the
PFS Relative Value Files under the
columns labeled ‘‘pre op, intra op, post
op’’ at https://www.cms.gov/medicare/
payment/fee-schedules/physician/pfsrelative-value-files. For example, CPT
code 27447 (Arthroplasty, knee, condyle
and plateau; medial AND lateral
compartments with or without patella
resurfacing (total knee arthroplasty)) is
a high-volume knee replacement
procedure where the postoperative
portion of the total payment is 21
percent. We are proposing that there
will be a postoperative transfer of care
20 percent of the time for CPT code
27447, and in those 20 percent of cases,
there will be a corresponding 21 percent
decrease in payment. This is reflected in
a utilization crosswalk of 0.958 for CPT
code 27447 as a result of this 4.2 percent
reduction (20 percent times 21 percent)
to capture this estimated reduction in
spending associated with our proposal
to require the use of these transfer of
care modifiers.
We note that for purposes of
estimating the utilization of the transfer
of care modifiers, our estimates include
increased reporting of the transfer of
care modifier for codes that are subject
to the RAND data collection exercise,
with the exception of cases where the
modifier is already used 5% of the time
or more. We recognize that this policy
will apply more broadly and seek
comment on this.
We note that the impact of the
conversion factor on this proposed
reduction in spending associated with
this policy is redistributed across the
PFS via an increase in the budget
neutrality adjustment to the conversion
factor. We are soliciting comments from
interested parties on our proposed
implementation of this postoperative
transfer of care policy.
We are also proposing a new HCPCS
code, GPOC1, to capture the additional
practitioner time and resources spent in
providing follow up post-operative care
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by a practitioner who did not perform
the surgical procedure. Additionally, we
expect the proposed global surgical addon code, HCPCS code GPOC1, will be
billed during the post-operative period
of 90 days following the procedure. We
expect that this code will be billed once
during the global period when the
patient is seen for an office/outpatient
(O/O) evaluation and management (E/
M) visit that is related to the recent
surgical procedure. We believe that this
code will be billed by a physician or
other practitioner (other than the
proceduralist or another practitioner in
the same practice) who is seeing the
patient for a visit during the postoperative period and did not furnish the
surgical procedure. We believe that
there is additional time, resources, and
complexity involved in the first O/O E/
M visit following a procedure that
should be captured during the postoperative period and may be billed in
certain instances when a transfer of care
modifier was not appended to the claim.
We are estimating a utilization of
approximately 40,000 total claims in the
first year for the proposed add-on code,
HCPCS code GPOC1. We calculated this
utilization estimate based on claims
data for procedure codes with a postoperative diagnosis code and an
observed to expected ratio (that is the
ratio of visits that are included in the
global surgical package compared to the
number of visits actually furnished) of
less than 25 percent. We anticipate that
uptake of HCPCS code GPOC1 would be
low initially, consistent with initial
uptake of other new services we have
finalized under the PFS. We are seeking
comment on these assumptions and
welcome input from the public.
5. Drugs and Biological Products Paid
Under Medicare Part B
a. Requiring Manufacturers of Certain
Single-Dose Container or Single-Use
Package Drugs To Provide Refunds With
Respect to Discarded Amounts
Section 90004 of the Infrastructure
Investment and Jobs Act (Pub. L. 117–
58, 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
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(subject to certain exclusions) for the
drug in a given calendar quarter. In the
CY 2023 and 2024 final rules, we
finalized several policies to implement
the provision. These policies are
described in section III.A.1 of this
proposed rule.
In section III.A.1 of this proposed
rule, we are proposing additional
policies for implementing the provision
including: a change in how we would
identify certain drugs that are excluded
from the definition of refundable drug
for those which payment has been made
under Part B for fewer than 18 months;
how we identify drugs from a singledose container; to require the JW
modifier if a billing supplier is not
administering a drug, but there are
discarded amounts during the
preparation process before supplying
the drug to the patient; and we discuss
an application for increased applicable
percentage (CMS 10835, OMB 0938–
1435).
In the CY 2024 PFS final rule (88 FR
79485 through 79490), we analyzed 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).804 Similar to our regulatory
impact analysis in the CY 2023 PFS
final rule (87 FR 70187 through 70188),
we used the 2021 JW modifier data to
estimate refund amounts as described in
section 1847A(h)(3) of the Act. In this
proposed rule, we performed the same
analysis on the 2022 JW modifier data.
First, we subtracted the percent units
discarded by 10 percent (the applicable
percentage for most refundable drugs),
except for drugs with an increased
applicable percentage as described in
§ 414.940(d). We note that since the data
indicating which drugs will have an
increased applicable percentage of 26
percent for the unique circumstances of
rarely utilized orphan drugs
(§ 414.940(d)(5)) will not be available
until the data is analyzed for the initial
report, we entered 26 percent for orphan
drugs furnished to fewer than 100
beneficiaries in CY 2022 based on data
on the CMS website.805 Therefore, the
drugs with increased applicable
percentage under § 414.940(d)(5) may
change each year based on claims data;
it is applied in this analysis for
estimation purposes only. Then, we
multiplied that percentage by the CY
2022 total allowed amount to estimate
the annual refund for a given billing and
804 https://data.cms.gov/summary-statistics-onuse-and-payments/medicare-medicaid-spendingby-drug/medicare-part-b-discarded-drug-units.
805 https://data.cms.gov/summary-statistics-onuse-and-payments/medicare-medicaid-spendingby-drug/medicare-part-b-spending-by-drug.
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payment code. The quarterly refund was
estimated by dividing the annual
estimate by 4. This analysis remains
appropriate for this proposed rule
because we are applying the finalized
policies from the CY 2023 and 2024 PFS
final rules to the most recent publicly
available data for the JW modifier data
from 2022.
Overall, according to data on the CMS
website 806 for Medicare Part B
discarded drug units in the 2022
calendar year, Medicare paid over $800
million for discarded amounts of drugs
from a single-dose container or singleuse package paid under Part B. In that
year, there were 55 billing and payment
codes with 10 percent or more
discarded units based on JW modifier
data. Of these, 10 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 not single source drugs or
biologicals; 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,
which were removed because we
anticipate making changes to coding
and payment policies regarding those
products in future rulemaking. After
these exclusions, there were 35 billing
and payment codes that met the
definition of refundable single-dose
container or single-use package drug. Of
these, 29 codes have discarded units
above the relevant finalized applicable
percentage, and 6 codes have discarded
units that would fall below increased
applicable percentages finalized 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
discarded by 10 percent (the applicable
percentage), except for drugs with
higher applicable percentages finalized
in the CY 2023 or 2024 final rules.
Then, we multiplied the appropriate
percentage by the CY 2022 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 $98.7 million in refunds
due from manufacturers for the calendar
year of 2022 ($24.7 million each
calendar quarter).
There are several limitations to this
analysis that could substantially affect
the total quarterly refund. Since new
drugs are continually being approved,
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
noted that this estimate is based on CY
2022 data for discarded drug amounts,
which, for reasons discussed in the CY
2023 PFS final rule (87 FR 69716), we
believe to be an underestimate due to
the frequent omission of the JW
modifier Claims edits for both the JW
and JZ modifiers will likely increase
accurate reporting of discarded drug
amounts. 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 807 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.
806 https://data.cms.gov/summary-statistics-onuse-and-payments/medicare-medicaid-spendingby-drug/medicare-part-b-discarded-drug-units.
807 https://www.cms.gov/Medicare/Medicare-Feefor-Service-Part-B-Drugs/
McrPartBDrugAvgSalesPrice.
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b. Impacts Related to the Payment Limit
Calculation When Manufacturers Report
Negative or Zero Average Sales
In section III.A.2 of this proposed
rule, CMS is proposing how payment
limits would be calculated when
manufacturers report negative or zero
ASP data to CMS. We are proposing to
amend § 414.904(i) to reflect CMS’
approach to setting a payment limit for
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circumstances in which negative or zero
ASP data is reported by a manufacturer
for a single source drug.
Specifically, we are proposing to
codify that in cases where negative or
zero ASP data is reported for some, but
not all, NDCs of a multiple source drug,
we would calculate the payment limit
using the positive ASP data reported for
the drug, except for the existing
carryover policy for multiple source
drugs that we would apply when
missing data results in a significant
change in the ASP payment limit. We
are proposing to move this carryover
policy for multiple source drugs within
§ 414.904(i) to fit within the structure of
the proposed new set of payment limit
methodologies. We are also proposing to
codify that in the case of a multiple
source drug for which negative or zero
ASP data is reported for all NDCs, we
would set the payment limit using the
most recent available positive ASP data
from a previous quarter until at least
one NDC for the drug has positive ASP
data for a quarter.
We are proposing to codify that in
cases where negative or zero ASP data
is reported for some, but not all, NDCs
of a single source drug that is not a
biosimilar, we would calculate the
payment limit using the positive ASP
data reported for the drug. We are
proposing to codify that for single
source drugs that are not biosimilars
with all negative or zero ASP data for
a given quarter, the payment limit
would be, until at least one NDC for the
drug has positive manufacturer ASP
data for a quarter, the lesser of 106
percent of the volume-weighted average
of the most recent available positive
manufacturer ASP data for at least one
NDC from a previous quarter and 106
percent of the wholesale acquisition
cost, and we would use 106 percent of
the lowest wholesale acquisition cost
per billing unit if there is more than one
wholesale acquisition cost per billing
unit.
We are also proposing to codify that
in cases where negative or zero ASP
data is reported for some, but not all,
NDCs of a biosimilar, we would
calculate the payment limit using the
positive ASP data reported for the
biosimilar. Lastly, we are proposing to
codify two scenarios when the
manufacturer reports negative or zero
ASP for all NDCs for a biosimilar for a
given quarter: (1) when positive ASP
data is available for another
biosimilar(s) with the same reference
product for the given quarter, we are
proposing to set the payment limit equal
to the sum of the volume-weighted
average of the positive ASP data from all
other biosimilars referencing the same
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reference product plus 6 percent (or 8
percent for a qualifying biosimilar
biological) of the amount determined
under section 1847A(b)(4) of the Act for
the reference biological product for the
given quarter; and (2) when either no
other biosimilars have been approved
for the same reference product or no
other biosimilars with the same
reference product report positive ASP
data for the given quarter, we are
proposing to set the payment limit equal
to the sum of the volume-weighted
average of the most recent available
positive ASP data from a previous
quarter plus 6 percent (or 8 percent for
a qualifying biosimilar biological) of the
amount determined under section
1847A(b)(4) of the Act for the reference
biological product for the given quarter.
With regard to estimating changes in
expenditures for CY 2025, because
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drugs and biologicals that report
negative or zero ASP data vary by
quarter and we cannot predict those that
will report such data, we used historic
claims data to perform an illustrative
analysis of how program spending
would have changed had the proposed
policies been in place in CY 2023. In the
analysis, we identified single source and
multiple source billing and payment
codes associated with negative or zero
ASP data for which we published
payment limits based on other
applicable pricing data (that is, the
manufacturer or published wholesale
acquisition cost) in the four calendar
quarters of 2023. For each such billing
and payment code, we used claims data
to identify: (1) the number of allowed
billing units in a calendar quarter (that
is, the number of billing units of a drug
or biological paid for by Medicare); (2)
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the payment limit per billing unit we
applied to that drug or biological under
our current policies; and (3) the
payment limit per billing unit our
proposal would apply to the billing and
payment code. We then subtracted the
product of the allowed billing units for
the payment limit under current
policies by the product of the allowed
billing units and the payment limit
under our proposal, and the difference
between the two is what the difference
between what Medicare spending on the
billing and payment codes would have
been if our proposed payment limit
methodologies were used in that
calendar quarter of 2023 and what
Medicare actually spent. These data and
net reductions (or increases) in program
spending are illustrated in Table 130.
BILLING CODE P
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TABLE 130: Theoretical Changes in Medicare Spending on Drugs and Biologicals with Negative or
Zero ASP Data Based on CY 2023 Claims Data
Allowed Billing
Current Policy
1 2023
Units
WAC+6
Pro osal
A Between Current and Pro osal
12770
15
$493.9695
J1020
47.111
J0600
406
10641
741,697
$337.4653
$2 347.56
$4.6110
$1.4914
$146 966.53
$5,708.5940
$5,592.5623
$47,108.84
$0.3456
$0.2660
$58,985.13
10720
116
S41.2552
$40.4146
$97.51
JlOOO
1,445
S29.6991
$26.4542
$4 688.84
J3300
360,762
$4.1851
$3.9035
$101,596.03
19214
62
S32.5738
$31.8462
$45.11
19302
601
S63.9572
$62.2336
$1,035.92
19320
0
$370.1838
$332.9778
$0.00
2 2023
Allowed Billing
Units
J1952
83.802
Current Policy
WAC+6
Pro osal
S98.4290
A Between Current and Pro osal
$88.7509
$811 044.34
10285
79
S46.3220
$41.8181
$355.81
10287
408
Sll.1300
$10.2985
$339.24
10600
435
$5 708.5940
$5 592.5623
$50 473.78
J1020
51,393
$4.6110
$3.1920
$72,927.54
13300
381,643
$4.1850
$3.9035
$107 421.25
19071
69,165
$3.8690
$3.5744
$20,374.38
19214
31
19268
114
19320
0
S32.5740
$31.8462
$22.56
$2,585.4140
$2,320.1163
$30,243.93
$370.1840
$332.9778
$0.00
Total
Allowed Billing
Units
Current Policy
WAC+6
Pro osal
A Between Current and Pro osal
10216
67
2.565
$2.23
$22.12
10636
74,355
0.795
$0.76
$2 503.99
19214
21
32.574
$31.85
$15.28
10287
154
11.13
$10.30
$128.05
J1572
1,991
56.1164
$44.54
$23,049.18
J1738
242
3.321333333
$3.13
$46.94
12360
13,633
16.536
$5.38
$152,117.66
13300
342,992
4.268885
$3.90
$125,314.01
J7342
23
30.0192
$30.01
$0.25
19046
42,252
48.54739429
$8.65
$1,685,649.00
19198
406
40.28
$24.67
$6,330.93
19296
3,417
9.655727059
$9.74
-$273.00
19393
27,650
21.2
$3.07
$501,318.72
Total
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Allowed Billing
Units
4 2023
Current Policy
WAC+6
A Between Current and Pro osal
Pro osal
J9071
140,721
3.869
$1.19
$377,386.29
JlOOO
1,003
32.6692
$30.68
$1 993.04
J1980
1,085
35.46442
$33.23
$2,421.54
10595
272
2.54347
$5.05
-$681.42
J0893
12,457
2.12
$2.24
-$1,495.80
J9198
237
40.28
$24.67
$3,700.20
J9394
56,602
53
$1.65
$2,906,338.93
Total
$3,289,662.78
BILLING CODE C
As illustrated in Table 131, the
application of the proposed payment
limit calculation approaches would
have reduced program spending for all
but three drugs that reported negative or
zero ASP data in calendar quarters in
2023 and reduced spending by a total of
$7,241,960.21 over the year.
We separately analyzed theoretical
changes in program spending for one
biosimilar product (ZIEXTENZO®,
Q5120) that has reported negative ASP
data for all NDCs for three consecutive
quarters beginning with the second
calendar quarter of 2022, and calculated
the payment limit under our proposed
method for biosimilars with negative or
zero ASP data and changes in program
spending for the three impacted quarters
had our proposed payment approach
been applied. We also analyzed
payment limits and theoretical changes
in program spending under two
alternatives considered under the
proposed rule. Under the first
alternative, we would include the ASP
data and billing units sold of the
reference biological for a given quarter
along with those of the other biosimilars
in the volume-weighted average
calculation. Under the second
alternative, we would set the payment
limit for a given quarter using the
biosimilar’s most recent available
positive ASP data and either 6 percent
(or 8 percent for qualifying biosimilar
biologicals) of the amount determined
under section 1847A(b)(4) of the Act for
the reference biological product (as
defined in § 414.902) for the given
quarter. The calculated payment limits
under the proposal and the two
alternatives, as well as the estimate
reductions in program expenditures, are
illustrated in Table 131.
• Md"
TABLE 131 : Theoref1caIChane;es m
e 1care S pend"me; on Q5120 tior 4Q 2023 th rou21h2Q2024
402023
Allowed
Billing
Units
2,299
$346.755
$118.369
$95.267
$29.24
102024
1179
$346.755
$117.313
$86.053
$27.40
202024
132
$346.755
$149.574
$127.623
$31.86
Payment limit:
Proposal
Spending A:
Proposal
Spending A:
First
Alternative
Payment limit:
Second Alternative
Spending A:
Second Alternative
402023
$525,058.988
$578,171.42
$729,975.52
102024
$270,512.618
$307,367.11
$376,513.91
202024
$26,027.867
$28,925.38
$41,565.72
$821,599.473
$914,463.917
$1,148,055.145
Total Savine:s
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Payment limit:
First
Alternative
We note that the spending change
estimates reflect preliminary claims
data. Providers and suppliers have a 12month period to submit Medicare Part B
claims, including claims for drugs
payable under Part B, so a lag exists
between the date of service when a drug
is administered and when the claim is
submitted and adjudicated. Because of
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this lag in finalized claims, there may
also be a lag in available JW modifier
data for any given date of service
quarter. An evaluation of July 2010
Medicare Part B claims in the
Physician/Supplier-Carrier setting
showed that 91.68, 96.84, and 98.32,
and 99.13 percent of claims were final
at 3, 6, 9, and 12 months, respectively,
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following the date of service. At 24 and
48 months, 99.83 and 100 percent of the
claims, respectively, were considered to
be final. Therefore, for the allowed
billing units and estimated program
expenditure reduction for the first 2
calendar quarters of CY 2024 are
significantly lower than we would
expect after claims mature for a full
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year. Over the 3 calendar quarters
(4Q2023, 1Q2024, and 2Q2024), our
proposed approach for calculating the
payment limit for biosimilars with only
negative or zero ASP and the two
alternative approaches would have
reduced program expenditures by at
least $821,599.473, $914,463.917, and
$1,148,055.145, respectively.
After assessing the effect of applying
the proposed alternative payment limit
calculation approaches to recent
Medicare FFS claims experience over
2023 and 2024, we estimate an average
annual gross Part B effect of $10 million
dollars in reduced program spending for
2025 and approximately $100 million
over 2025 to 2034, as shown in Table
134. Historically we have observed that
negative or zero ASP pricing data may
occasionally occur for a drug when it is
discontinued or substituted away for
another product and assume this to
occur in the future. Moreover, given the
infrequency of negative or zero ASP
data, we do not expect in all years that
alternative pricing approaches will be
necessary or to affect drugs with
material levels of utilization. Therefore,
for a low estimate we project the policy
to have a negligible effect on program
spending for the projection window. To
illustrate a potential high impact
estimate scenario, the affected
utilization from 2023 was doubled
relative to the observed data. Please note
that the actual effect of the policy will
be specific to the affected drugs in any
given year and considerations that affect
their utilization and pricing, therefore
actual experience may deviate
considerably from these projections.
c. Impacts Related to the Payment of
Radiopharmaceuticals in the Physician
Office
In section III.A.3. of this proposed
rule, while we evaluate our broader
policies in this space for future
rulemaking, we are proposing to codify
in regulations at § 414.904(e)(6) that, for
radiopharmaceuticals furnished in a
setting other than the hospital
outpatient department, MACs shall
determine payment limits for
radiopharmaceuticals based on any
methodology used to determine
payment limits for
radiopharmaceuticals in place on or
prior to November 2003. Such
methodology may include, but is not
limited to, the use of invoice-based
pricing. The proposal does not
necessarily change the payment
methodology in place for a MAC but
rather clarifies that any payment
methodology that was being used by any
MAC prior to the enactment of the
MMA can continue to be used by any
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MAC. Therefore, we believe that this
proposal will have no impact on
Medicare spending.
d. Impacts Related to
Immunosuppressive Therapy
In section III.A.4 of this proposed
rule, we are proposing to modify
regulations to include orally or enterally
administered compounded formulations
of FDA-approved drugs that have
approved immunosuppressive
indications, or that have been
determined by a Medicare
Administrative Contractor (MAC) to be
reasonable and necessary for specific
purposes in immunosuppressive
treatment in the immunosuppressive
drug benefit. In addition, we are
proposing two changes regarding
supplies of immunosuppressive drugs to
align with current standards of practice
and reduce barriers to medication
adherence: to allow payment of a supply
fee for a prescription of a supply of up
to 90 days and to allow prescriptions for
these immunosuppressive drugs to be
refillable.
CMS has limited insight into how
many patients who are currently
prescribed compounded
immunosuppressive drugs would have
their immunosuppressive medication
paid for under Part B if the proposed
changes to the immunosuppressive drug
benefit are finalized. Medicare Part D
claims data for CY 2023 indicates there
were 2,662 prescriptions filled that year
for compounded immunosuppressive
drugs that could have been
administered through oral or enteral
routes (that is, that would likely be paid
under Part B if the immunosuppressive
drug benefit revision is finalized as
proposed). We estimate that this number
of prescriptions correlates to up to 2,000
Part D enrollees that were prescribed
compounded immunosuppressive drugs
that would be covered if the proposal is
finalized. However, we do not know
how many Part B beneficiaries currently
have their compounded
immunosuppressive drugs paid for by
means other than a Part D policy. And
finally, and perhaps most importantly,
compounded drugs are priced by each
A/B and DME MAC and have no
estimable payment limit. Thus, we are
unable to estimate the cost shift from
Part D and other plans to Part B that
would result from a finalization of the
immunosuppressive drug benefit
proposed policies, including allowing
payment of supply fees for prescriptions
fills for supplies of up to 90 days and
for immunosuppressive drugs to be
refillable.
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e. Impacts Related to Clotting Factors
In section III.A.5. of this proposed
rule, we are proposing to update
§ 410.63(b) to clarify existing CMS
policy that blood clotting factors must
be self-administered to be considered
clotting factors for which the furnishing
fee applies. Additionally, we are
proposing to clarify at § 410.63(c) that
the furnishing fee is only available to
entities that furnish blood clotting
factors, unless the costs associated with
furnishing the clotting factor are paid
though another payment system,
including the PFS. That is, we are
proposing to clarify through revisions to
§ 410.63 that clotting factors (as
specified in section 1861(s)(2)(I) of the
Act) and those eligible to receive the
clotting factor furnishing fee (as
specified in section 1842(o)(5) of the
Act) are the same subset of products.
Accordingly, the clarification will not
be adding a furnishing fee to any new
products. Therefore, we believe that this
clarification will have no impact on
Medicare spending.
6. Impacts Related to Rural Health
Clinics (RHCs) and Federally Qualified
Health Centers (FQHCs)
In section III.B.2. of this proposed
rule, we are proposing to require RHCs
and FQHCs to bill the individual codes
that make up the general care
management HCPCS code, G0511.
Payment amounts for some services that
comprise HCPCS code G0511 are less
than the payment amount for G0511 and
if an RHC or FQHC mostly furnishes
these services, they could see a potential
decline in payment. We are also
proposing to allow RHCs and FQHCs to
bill the add-on codes for additional time
spent once the minimum threshold of
time was met to account for a complete
encounter. This could potentially offset
any decrease in payments. In addition,
beginning in CY 2025, we are proposing
to adopt the coding and policies
regarding Advanced Primary Care
Management (APCM) services proposed
under the PFS, as discussed in section
II.G of this proposed rule. In terms of
estimated impacts to the Medicare
program, we believe that the proposals
discussed in section III.B.2 of this
proposed rule would have no impact on
Medicare spending.
In section III.B.3. of this proposed
rule, we are proposing the policy to
continue to adopt the definition
‘‘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, 2025, for
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RHCs and FQHCs. We are also
proposing, on a temporary basis, to
allow payment for non-behavioral
health visits furnished via
telecommunication technology in a
manner that would closely align with
the payment mechanisms mandated by
statute through December 31, 2024, that
is, RHCs and FQHCs would continue to
bill for RHC and FQHC services
furnished using telecommunication
technology services by reporting HCPCS
code G2025 on the claim through
December 31, 2025. In addition, we are
proposing to continue to delay the inperson visit requirement for mental
health services furnished via
communication technology by RHCs
and FQHCs to beneficiaries in their
homes until January 1, 2026. We believe
these RHC/FQHC proposals related to
telecommunication technology would
have a negligible impact on Medicare
spending.
In section III.B.4. of this proposed
rule, we discuss the implementation of
section 4124 of the CAA, 2023. Section
4124 of the CAA, 2023 established
Medicare coverage for intensive
outpatient (IOP) services furnished by a
hospital to its outpatients, or by a
community mental health center, a RHC
or a FQHC, as a distinct and organized
intensive ambulatory treatment service
offering less than 24-hour daily care in
a location other than an individual’s
home or inpatient or residential setting,
effective January 1, 2024 (88 FR 81838).
We are proposing to provide a payment
rate for 4 or more services per day in the
RHC and FQHC setting. In terms of
impact, we believe that this proposal
would have negligible impact on
Medicare spending.
In section III.B.5. of this rulemaking,
we are proposing to allow RHCs and
FQHCs to bill for Part B preventive
vaccines and the administration at the
time of service. We propose that
payments for these claims will initially
be made according to Part B preventive
vaccine payment rates in other settings,
but that they will be annually
reconciled with the facilities’ actual
vaccine costs on their cost reports,
which is current practice and statutorily
mandated. Therefore, we believe that
this proposal would have no impact on
Medicare spending.
In section III.B.6. of this proposed
rule, we discuss our proposal relating to
RHC productivity standards. We are
proposing to remove productivity
standards for RHCs and therefore
believe that the proposal discussed in
this section III.B.6. of this proposed rule
would have no impact on Medicare
spending.
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In section III.B.8. of this proposed
rule, we are clarifying that when RHCs
and FQHCs furnish dental services that
align with the inextricably linked
policies and operational requirements in
the physician setting, we would
consider those services to be a
qualifying visit and the RHC would be
paid at the RHC AIR and the FQHC
would be paid under the FQHC PPS. We
believe this clarification related to
dental services furnished in RHCs and
FQHCs would have a negligible impact
on Medicare spending. Even though this
is a new benefit, it would only cover
dental services inextricably linked to
specific medical services as described in
section II.J. of this proposed rule.
7. Changes in the RHC and FQHC CfCs:
Provision of Services (§ 491.9(a)(2) and
(c)(2)(ii) and (vi))
Provision of Services (§ 491.9)
At § 491.9(a)(2), we are proposing to
explicitly state that an RHC and FQHC
must provide primary care services and
an RHC cannot be a rehabilitation
agency or a facility that is primarily for
the care and treatment of mental
diseases. We believe this proposal
would result in real, but difficult to
estimate, long-term benefits to patients
receiving services at RHCs and FQHCs,
as well as economic benefits to the
clinic or center. Regarding the estimated
impacts on the Medicare program, the
proposals discussed in section III.C.2 of
this proposed rule would have no
impact on Medicare spending.
This proposed change would provide
RHCs with additional flexibility to
provide outpatient specialty services onsite or hire additional providers with
specialized expertise to meet the needs
of their community, including internal
medicine, pediatrics, geriatrics,
obstetrics and gynecology, dermatology,
cardiology, neurology, endocrinology,
and ear, nose and throat. As a result,
RHCs would be able to improve access
to care by serving more patients in
communities served by RHCs and
FQHCs, including rural communities,
and not requiring patients to travel
longer distances to receive specialty
services. Patients could have access to
specialists within their own
communities, improving overall access
for Medicare beneficiaries. Moreover, if
this policy were to be finalized, CMS
would no longer determine or enforce
the standard of RHCs ‘‘being primarily
engaged in furnishing primary care
services.’’ 808 which has been enforced
808 Centers for Medicare & Medicaid Services.
(2020, February 21). State Operations Manual
Appendix G—Guidance for Surveyors: Rural Health
Clinics (RHCs) (pp. 63–64). https://www.cms.gov/
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via the sub-regulatory guidance
contained in the State Operations
Manual Appendix G—Guidance for
Surveyors: Rural Health Clinics (RHCs).
Resources that clinics are currently
using to evaluate if they are meeting this
requirement could be devoted to other
administrative tasks. Therefore, we
believe that there would be no burden
imposed on RHCs or FQHCs related to
this proposal.
We are also proposing to remove
hemoglobin and hematocrit (H&H) lab
tests from the list of specific tests RHCs
must provide, as well as update the
language regarding the primary
culturing requirement to reflect current
standards of practice at § 491.9(c)(2)(ii)
and (vi), respectively. As discussed in
section III.C.2.b of this proposed rule,
RHCs report the H&H lab requirement is
particularly burdensome and costly for
clinics due to purchasing and
maintaining the equipment, even if it is
seldom or never used.
This proposed change would reduce
the overall burden for RHCs by reducing
the number of diagnostic tests they must
provide. RHCs would no longer be
required to purchase or maintain H&H
lab test equipment or supplies, freeing
up resources for other essential services.
H&H lab tests are most often ordered as
part of a larger panel of labs that is not
provided at the RHC. When this is the
case, patients will receive the H&H as
part of that larger panel at an outside lab
that offers the larger panel of labs. These
patients may be inconvenienced by
having to travel to another laboratory,
but this limits the number of specimens
they must provide for the laboratory
tests, reducing the number of times a
patient’s veins must be accessed for
blood draws. RHCs report that when
laboratory tests are ordered that are not
provided by the RHC, such as a
comprehensive blood count (CBC), their
patients are often sent to the nearest
hospital that would have a full-service
laboratory available to perform the test.
A CBC test looks at a patient’s overall
health and can detect a wide range of
conditions that the hemoglobin and
hematocrit tests cannot. This ensures
comprehensive patient care and may
result in a decreased need for follow-up
testing and decreased patient
turnaround time.809
Currently, there are approximately
5,462 Medicare-certified RHCs.
Applying the most recent data from
Regulations-and-Guidance/Guidance/Manuals/
downloads/som107ap_g_rhc.pdf.
809 Mayo Foundation for Medical Education and
Research. (2023, January 14). Complete blood count
(CBC). Mayo Clinic. https://www.mayoclinic.org/
tests-procedures/complete-blood-count/about/pac20384919.
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2021, 66 percent (3,605) of RHCs are
designated as ‘‘provider-based,’’ which
are owned and operated as an integral
part of a hospital, nursing home, or
home health agency.810 The remaining
34 percent (1,857) of RHCs are
‘‘independent clinics’’ and, though
uncommon, may be owned and/or
operated by a healthcare system.
Therefore, we assume that at most, half
of the independent clinics, for a total of
929 RHCs, would continue to provide
H&H tests because it is less likely that
they are a part of a healthcare system.
As a result, we assume that 4,534 (3,605
provider-based RHCs + 929 independent
clinics) RHCs will continue to refer
patients to a fully certified laboratory
rather than directly provide the H&H
test. Because the regulatory
requirements at § 491.9 States that RHCs
must provide H&H lab tests on-site,
RHCs must have and maintain the
appropriate equipment to perform these
tests, even if the equipment is not
utilized. There are variations in the
H&H testing equipment RHCs may use;
however, we note that the average cost
of an H&H meter or analyzer costs
approximately $1,200 for the system
and is replaced on average every 3
years. The systems also have an
approximate $100 annual maintenance
fee. We estimate that over the next 3
years, 4,534 RHCs will each save
approximately $1,500. This would
result in a total annual savings of
$2,267,000 ((4,534 RHCs that typically
refer patients to a fully certified
laboratory × $1,500)/3). After 3 years,
the RHC program would save a total of
$6,801,000 (4,534 × $1,500).
8. Clinical Laboratory Fee Schedule
In section III.D. of this proposed rule,
we outline statutory revisions to the
data reporting period and phase-in of
payment reductions under the CLFS. In
accordance with section 502 of the
FCAOEA, 2024, 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 2025. Section 502(b) of the
FCAOEA, 2024 delays the next data
810 Gale, J.A., Croll, Z., Croom, J., Munk, L., &
Jonk, Y. (2022). Community Characteristics and
Financial and Operational Performance of Rural
Health Clinics in the United States: A Chartbook.
University of Southern Maine, Muskie School of
Public Service, Maine Rural Health Research
Center. https://digitalcommons.usm.maine.edu/cgi/
viewcontent.cgi?article=1016&context=clinics.
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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,
2025, through March 31, 2025.
Subsequently, the next private payor
rate-based CLFS update for these tests
will be effective January 1, 2026, instead
of January 1, 2025. In addition, we are
proposing conforming changes to our
requirements for the phase-in of
payment reductions to reflect section
502(a) of the FCAOEA, 2024.
Specifically, we are proposing to revise
§ 414.507(d) to indicate that for CY
2024, payment may not be reduced by
more than 0.0 percent as compared to
the amount established for CY 2023, and
for CYs 2025 through 2027, 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 outlined 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 FCAOEA, 2024 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
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.
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Regarding the proposed conforming
changes to our requirements for the
phase-in of payment reductions, we
note that for CYs 2025 through 2027,
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 phasein reduction in CY 2025.
9. Effects of Proposals Relating to the
Medicare Diabetes Prevention Program
Expanded Model
a. Effects on Beneficiaries
We are proposing to modify certain
Medicare Diabetes Prevention Program
(MDPP) expanded model policies to: (1)
align MDPP terminology and definitions
with the proposed 2024 Centers for
Disease Control and Prevention (CDC)
Diabetes Prevention Recognition
Program (DPRP) Standard 811 definitions
for ‘‘in-person with a distance learning
component,’’ ‘‘combination with an
online component,’’ and ‘‘online’’; (2)
remove the MDPP bridge payment; (3)
provide a more effective option for a
beneficiary to self-report their weight in
an MDPP distance learning session, by
submitting 2 photos; (4) facilitate
Medicare Administrative Contractors
(MACs) in processing claims for a MDPP
make-up session held on the same day
as a regularly scheduled session by
requiring use of an existing HCPCS
modifier; and (5) align current rule
language with previous rulemaking.
MDPP is a non-pharmacological
behavioral intervention consisting of up
to 22 sessions using a CDC approved
National Diabetes Prevention Program
(National DPP) curriculum.812 CDC
administers a national quality assurance
program recognizing eligible
organizations that furnish the National
DPP through its evidence based DPRP
Standards, which are updated every
three years. The 2024 CDC DPRP
Standards replace the 2021 CDC DPRP
Standards in June 2024.813
The Calendar Year (CY) 2021 PFS
final rule allowed virtual delivery of
MDPP during the COVID–19 Public
811 Centers for Disease Control and Prevention
Diabetes Prevention Recognition Program.
Standards and Operating Procedures. Requirements
for CDC Recognition. June 2024. https://
nationaldppcsc.cdc.gov/s/article/DPRP-Standardsand-Operating-Procedures.
812 https://www.cdc.gov/diabetes/prevention/
resources/curriculum.html.
813 Centers for Disease Control and Prevention
Diabetes Prevention Recognition Program.
Standards and Operating Procedures. Requirements
for CDC Recognition. June 2024. https://
nationaldppcsc.cdc.gov/s/article/DPRP-Standardsand-Operating-Procedures.
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Health Emergency (PHE) (85 FR 84830).
Improvements to MDPP in the Calendar
Year 2024 final rule included a
simplified payment structure to allow
for fee-for-service (FFS) payments for
beneficiary attendance, while retaining
the performance-based payments for
diabetes risk reduction (that is, weight
loss) (88 FR 79241). This policy also
extended certain PHE flexibilities
including the option to deliver some or
all MDPP sessions via distance learning,
until December 31, 2027 (88 FR 79241).
Another PHE flexibility extended
through December 31, 2027, at 42 CFR
410.79(e)(3)(iii), is for MDPP suppliers
to obtain weight measurements for
beneficiaries using one of the following
options: (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.
The 2024 CDC DPRP Standards were
proposed after the CY 2024 PFS was
finalized. To align with 2024 CDC DPRP
Standards, we are proposing to update
the MDPP definition for ‘‘online’’
delivery to align with the proposed 2024
CDC DPRP definition. We are also
proposing to add terms and definitions
for CDC’s new modalities including ‘‘inperson with a distance learning
component’’ and ‘‘combination with an
online component’’ and to remove the
existing ‘‘combination’’ term and
definition. Lastly, we are specifying that
MDPP make-up sessions must be
provided in-person or via distance
learning delivery, as required by the CY
2024 PFS final rule.4
Furthermore, the MDPP bridge
payment (G9880), which is a payment
made to the subsequent supplier for the
first session when a beneficiary
switches MDPP suppliers, is no longer
necessary in MDPP’s CY 2024 FFS
payment structure and may increase risk
for fraud, waste, or abuse. We are
proposing to remove the bridge payment
from the MDPP CY 2025 Fee Schedule.
In addition, we have identified a more
effective option for a beneficiary to selfreport their weight in an MDPP distance
learning session. We have also
identified the need to require suppliers
to use Current Procedural Terminology
(CPT) Modifier 79 to allow Medicare
Administrative Contractors (MACs) to
identify a claim for an MDPP make-up
session held on the same day as a
regularly scheduled session. Finally, we
are proposing to align current rule
language with previous rulemaking
pertaining to MDPP terminology,
requirements, and payment structure.
All the proposed changes for MDPP in
CY 2025 are conforming or
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administrative and expected to have a
modest impact on beneficiaries’ access
to MDPP services. Aligning with 2024
CDC DPRP Standards for MDPP delivery
modes may help expand beneficiary
access by streamlining data submission
for MDPP suppliers and increasing the
number of MDPP eligible organizations
that enroll in Medicare as MDPP
suppliers. Additionally, allowing for
MDPP make-up sessions to be
scheduled on the same day as regularly
scheduled sessions would increase
flexibility for both MDPP suppliers and
beneficiaries and may help expand
access for beneficiaries with
transportation and other scheduling
issues that prevent scheduling sessions
more than one day a week or month.
Increased flexibility in scheduling
MDPP sessions may help to address a
lack of MDPP suppliers in certain
communities and challenges related to
beneficiary logistics concerning course
attendance.
Additionally, we are proposing to
provide a more effective option to
beneficiaries to self-report weight for a
MDPP distance learning session, by
allowing beneficiaries to submit 2 (two)
photos to capture both the beneficiary
weight on the digital scale and the
beneficiary visible in their home.
Current MDPP supplier standards at
§ 424.205 require beneficiary weight to
be reported at each MDPP session
attended. This proposed change would
help to address concerns voiced by
MDPP suppliers who have reported that
many of their beneficiaries are unable to
take a picture while standing on their
home scales due to risk of injury and
physical health limitations. This new
flexibility may promote more consistent
collection of weight for MDPP sessions.
Lastly, we do not expect removing the
MDPP bridge payment to have an
impact on beneficiary access. This
payment for the first session attended
with a new supplier when a beneficiary
switches MDPP suppliers is not
necessary in MDPP’s CY 2024 FFS
payment structure that includes
payment for every session attended and
historically has been submitted by few
MDPP suppliers.
Overall, these modifications address
MDPP supplier and beneficiary needs
based upon available monitoring and
evaluation data received to date,
feedback from Medicare Advantage
plans and existing MDPP suppliers, and
feedback from beneficiary focus groups.
The changes are also in response to
comments from interested parties made
through public comments in response to
prior rulemaking.
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b. Effects on the Market
We anticipate that the conforming and
administrative changes proposed in this
rulemaking are likely to result in modest
increases of MDPP suppliers and
beneficiary access to the set of MDPP
services. We anticipate that this would
assist in contributing to a reduction of
the incidence of diabetes among eligible
Medicare beneficiaries. As of April
2024, there are approximately 810 inperson organizations nationally that are
eligible to become MDPP suppliers
based on their preliminary or full CDC
Diabetes DPRP status. However, only 36
percent of these eligible in-person
organizations are participating in
MDPP.814 Aligning with CDC DPRP
delivery modes, particularly adding the
new ‘‘in-person with a distance learning
component’’ mode, is expected to help
increase recruitment of new DPRP
organization as MDPP suppliers, who
currently would need to obtain both inperson and distance learning CDC DPRP
recognition to deliver sessions via both
modalities. Furthermore, only about
one-third of MDPP suppliers have
submitted MDPP-related claims.815 Our
proposed change to remove the MDPP
bridge payment would help to further
simplify the payment structure, which
is expected to have a positive impact on
supplier claim submissions. While
requiring MDPP suppliers to add a
modifier to indicate that a claim is for
a MDPP same day make-up session does
add complexity because we have
proposed to use an existing CPT
modifier in use and recognized by the
MACs, we expect this addition to
require minimal changes in claim
processing systems. Additionally, this
modifier is only to be used for same day
make-up sessions, which are only
allowed once per week, and, while an
important tool to increase access for
beneficiaries with barriers to
participation in MDPP, are not expected
to be used for most session attendance
claims. In summary, we believe that
having more flexibility in how the set of
MDPP services are delivered would
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 that
MDPP suppliers may be eligible to
receive payments for furnishing MDPP
services and meeting performance
814 Centers for Disease Control and Prevention.
Diabetes Prevention Recognition Program
Application. Registry of All Recognized
Organizations. https://dprp.cdc.gov/Registry.
815 Unpublished MDPP monitoring data. 2023.
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targets related to beneficiary weight loss
and attendance. We anticipate that the
proposed change to the MDPP payment
structure would have minimal impact
on total payment for MDPP services. A
smaller proportion of MDPP suppliers,
only 9.8 percent since the start of the
program through April 2024, have
submitted claims for the MDPP bridge
payment, with an even smaller
proportion of 2.7 percent having
received payment for a bridge payment
claim. According to CDC DPRP data,
less than 1 percent of MDPP sessions are
same day make-up sessions.816 The total
maximum payment per beneficiary for
MDPP of $768 would remain unchanged
by our proposals.
d. Effects on the Medicare Program
(a) Estimated 10-Year Impact of MDPP
The changes proposed this year for
implementation in the CY PFS 2025 are
expected to have no impact on Medicare
spending.
lotter on DSK11XQN23PROD with PROPOSALS2
10. Modifications Related to Medicare
Coverage for Opioid Use Disorder (OUD)
Treatment Services Furnished by
Opioid Treatment Programs (OTPs)
As outlined in section III.F.2 of this
proposed rule, we are proposing to
permanently allow periodic assessments
to be furnished via audio-only
communication when two-way audiovideo communications technology is not
available to the beneficiary, 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 are also proposing to allow
the OTP intake add-on code to be
furnished via two-way audio-video
communications technology when
billed for the initiation of treatment
with methadone to the extent that the
use of audio-video telecommunications
technology to initiate treatment with
methadone is authorized by DEA and
SAMHSA at the time the service is
furnished, an OTP determines that an
adequate evaluation of the patient can
be accomplished via a via an audiovisual telehealth platform, and all other
applicable requirements are met. We
believe the Part B cost impact of these
flexibilities for the use of
telecommunications will be minimal
because we do not expect that these
flexibilities will significantly increase
the frequency with which medically
necessary intake activities and periodic
assessments are furnished, and since the
payment rate for these services will be
the same regardless of if an OTP
816 Diabetes Prevention Recognition Program.
Unpublished data. April 2024.
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furnishes these services via
telecommunications or in-person.
In section III.F.3 of this proposed rule,
CMS is proposing to update the
payment rate for intake activities
(HCPCS code G2076) by adding in the
value of the non-facility rate for SDOH
risk assessments described by HCPCS
code G0136 (Administration of a
standardized, evidence-based Social
Determinants of Health Risk
Assessment, 5–15 minutes, not more
often than every 6 months). We believe
updating the payment amount for intake
activities with an addition of HCPCS
code G0136 would serve as a reasonable
proxy to reflect the value and resources
required by new SAMHSA standards for
initial assessment service activities at
§ 8.12(f)(4)(i) that OTPs are required to
provide, including an assessment to
identify a patient’s unmet HRSNs or the
need for harm reduction intervention
and recovery support services that are
critical to the treatment of an OUD.
Currently, the CY 2024 payment rate for
the intake add-on code (G0276) is
$201.73 and adding the value of a
crosswalk to the CY 2024 non-facility
rate of $18.66 would result in a payment
rate of approximately $220.39. The
payment rate would also continue to be
updated annually by the percentage
increase in the Medicare Economic
Index (MEI) and the Geographic
Adjustment Factor (GAF) as codified in
§ 410.67(d)(4)(ii) through (iii).
According to historical claims data for
intake activities (HCPCS code G2076)
furnished by OTPs from the beginning
of CY 2020 through the end of CY 2023,
the number of claims for intake
activities is low. Due to low utilization
of the intake activities add-on code
(HCPCS code G2076), CMS estimates
that an increase in the add-on payment
amount to HCPCS code G2076 by $18.66
per claim would still result in a
negligible cost to the Medicare program.
Lastly, in section III.F.4 of this proposed
rule, we are proposing to establish
payment for new opioid agonist and
antagonist medications that were
recently approved by the FDA. We
proposed to include a new add-on code
to the bundled payment for a new
opioid overdose reversal product,
nalmefene hydrochloride nasal spray
product (Opvee®), which includes one
carton of two, 2.7 mg nasal sprays of
nalmefene. We proposed to price the
drug component of this add-on code for
nalmefene according to the ASP
payment methodology set forth in
section 1847A, except that the payment
amount shall be ASP + 0. The non-drug
component of this add-on code would
also include overdose education
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62179
furnished in conjunction with
nalmefene, and it would be updated
annually by the percentage increase in
the MEI and GAFs consistent with other
opioid antagonist medications in
§ 410.67(d)(4)(ii) through (iii). We are
limiting Medicare payment to OTPs for
nalmefene to one add-on code every 30
days, however, we will allow exceptions
to this limit in the case where the
beneficiary overdoses and uses the
initial supply of nalmefene dispensed
by the OTP, to the extent that it is
medically reasonable and necessary to
furnish additional doses of nalmefene.
We are also proposing payment for the
weekly formulation of the new
extended-release injectable
buprenorphine product Brixadi®, via a
new weekly bundled payment code that
includes a drug and non-drug
component. We proposed to price the
drug component consistent with our
payment methodology for implantable
and injectable medications codified
§ 410.67(d)(2)(i)(A), and we proposed to
limit the payment amount to 100percent of ASP and to use a crosswalk
to the weekly Brixadi® formulation
described by HCPCS code J0577
(Injection, buprenorphine extended
release (brixadi), less than or equal to 7
days of therapy). The non-drug
component (individual and group
therapy, SUD counseling, toxicology
testing) would also include
administration of an injection based on
CPT code 96372 (Therapeutic,
prophylactic, or diagnostic injection
(specify substance or drug);
subcutaneous or intramuscular);
updated annually by the percentage
increase in MEI and GAFs. CMS is
further proposing to update the drugcomponent of the existing HCPCS code
(G2069) for monthly injectable
buprenorphine to include the monthly
formulation of Brixadi® based on a
crosswalk to HCPCS code J0578
(Injection, buprenorphine extended
release (brixadi), greater than 7 days
and up to 28 days of therapy). We
proposed to continue to use the existing
payment methodology for both the drug
and non-drug component of G2069 after
averaging in payment for the monthly
formulation of Brixadi®. Since the
proposed payment methodology for the
new add-on code for Opvee® (GOTP1),
the weekly bundled payment for weekly
Brixadi® (GOTP2), and the update to the
monthly bundled payment for injectable
buprenorphine (HCPCS code G2069) is
based on comparable and existing drugs
billed under the Medicare OTP benefit,
and assuming an OTP may provide
these new drugs to a Medicare
beneficiary in lieu of the comparable
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and existing drugs under the Medicare
OTP benefit (e.g., Opvee® instead of
Narcan® or Kloxxado®, or the weekly or
monthly formulation of Brixadi® instead
of Sublocade®), then CMS estimates the
financial impacts of these new drugs
would be negligible.
lotter on DSK11XQN23PROD with PROPOSALS2
11. Medicare Shared Savings Program
a. General Impacts
As of January 1, 2024, 10.8 million
Medicare beneficiaries receive care from
a health care provider in one of the 480
ACOs participating in the Shared
Savings Program, one of the largest
value-based care programs in the
country. The Shared Savings Program
proposed policies in this proposed rule
would advance Medicare’s value-based
care strategy of growth, alignment, and
equity, with many proposals supporting
more than one of these goals. The
proposed policies in this proposed rule
are designed, in part, to further improve
the quality of care furnished by ACOs
by revising the quality performance
standard and reporting requirements,
broaden program participation
particularly in underserved
communities, and promote the
continued integrity and fairness of
Shared Savings Program financial
calculations.
As described in section III.G.7.b of
this proposed rule, under the
benchmarking methodology for
agreement periods beginning on January
1, 2024, and in subsequent years, CMS
calculates two adjustments in
establishing the historical benchmark, a
regional adjustment (refer to § 425.656)
and a prior savings adjustment (refer to
§ 425.658). We determine which
adjustment is applied to the benchmark,
either the regional adjustment, prior
savings adjustment, or no adjustment
(refer to § 425.652(a)(8) and (c)). One of
the changes to the Shared Savings
Program financial methodology
finalized with the CY 2024 PFS final
rule (see 88 FR 79185 through 79195,
see also 88 FR 79494 and 79495) was to
mitigate the impact of the negative
regional adjustment on the benchmark
for ACOs in agreement periods
beginning on January 1, 2024, and in
subsequent years. We explained our
belief that this change would further
encourage continued participation
among high-cost ACOs that serve
medically complex beneficiaries by
eliminating the potential of a lower
benchmark due to an overall negative
regional adjustment, and may also
encourage ACOs serving such
populations that may have otherwise
been discouraged from participating in
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the Shared Savings Program by the
prospect of a lower benchmark to join
(see 88 FR 79188, see also 88 FR 79494
and 79495). Under this approach, an
ACO with an overall negative regional
adjustment that was not eligible for a
prior savings adjustment would
ultimately receive no adjustment,
upward or downward, to its benchmark
(see § 425.652(a)(8)(iii) and see also 88
FR 79190). The proposed Health Equity
Benchmark Adjustment (HEBA)
described in section III.G.7.b of this
proposed rule would add a third avenue
for ACOs to receive a positive
adjustment to their historical
benchmark, and would be most
impactful for new ACOs serving
medically complex, high-cost
populations in underserved
communities.
We combined an analysis of the
impact of the HEBA on currently
participating ACOs with the projected
impact of HEBA on new ACOs not yet
participating in the Shared Savings
Program, to generate an overall impact
estimate of the HEBA. The HEBA would
likely have a limited impact on
currently participating ACOs. Only
about 20 percent of the 456 ACOs
participating in performance year 2023
were estimated to have a proportion of
assigned beneficiaries who were
enrolled in the Medicare Part D LIS or
dually eligible for Medicare and
Medicaid equal to or greater than 20
percent. That 20 percent threshold
would have to be met for an ACO to be
eligible for the HEBA under the HEBA
proposal (as discussed in section
III.G.7.b. of this proposed rule, and
specified in proposed § 425.662(b)(3)).
Of that 20 percent of ACOs participating
in performance year 2023 that were
estimated to have a proportion of
assigned beneficiaries who were
enrolled in the Medicare Part D LIS or
dually eligible for Medicare and
Medicaid equal to or greater than 20
percent, only about one quarter of such
ACOs were estimated to not already be
eligible for a higher benchmark
adjustment from either a positive
regional adjustment or a prior savings
adjustment. That is, about 5 percent of
ACOs participating in performance year
2023 were estimated to benefit from the
proposed HEBA policy at rebasing
(median effect about 1 percent increase
to the benchmark), because an ACO
would receive the proposed HEBA only
if the HEBA adjustment were higher
than the existing ‘‘higher of’’ adjustment
method (see discussion in section
III.G.7.b of this proposed rule, and
proposed §§ 425.652(a)(8)(ii)(B)(1) and
PO 00000
Frm 00586
Fmt 4701
Sfmt 4702
425.662(c)). The proposed HEBA is
projected to increase program spending
for existing ACOs by about $140 million
over 10 years.
The number of ACOs that would be
incentivized to participate in the Shared
Savings Program by the HEBA is
uncertain. Changes to the Shared
Savings Program finalized in the CY
2023 CY 2024 PFS final rules were
already projected to increase program
participation among ACOs with higher
spending and provide more
opportunities for improving care and
reducing spending (see 87 FR 70191
through 70196, and 88 FR 79494 and
79495). Therefore, we can reasonably
estimate that at least some new ACOs
may join and succeed in the Shared
Savings Program regardless of the
benefit afforded to them by the
proposed HEBA (if finalized). Savings to
the Shared Savings Program are
expected to grow to the extent that the
HEBA were to cause new, highspending ACOs to participate—that is,
ACOs serving populations with riskadjusted spending that is significantly
higher than corresponding regional
benchmark spending at baseline. We
project in the 2034 performance year,
the proposed HEBA would likely
increase program participation by 25
additional ACOs (but our estimates of
increased program participation range
from 0 to 100 additional ACOs), as
compared to program participation
today, and on net increase Federal
Medicare program savings by $460
million over the 2025–2034 period
because of this new participation.
The estimated impact of the proposed
HEBA, accounting for both its impact on
currently participating ACOs that are
assumed to renew their participation in
the Shared Savings Program over the
next 5 years and new ACOs that are
expected to participate in the program
for the first time over the next 10 years,
is shown in Table 132. Mean Shared
Savings Program spending is expected
to be reduced by $320 million over the
next ten years as a result of the HEBA,
if finalized. However, uncertainty
regarding the number of high spending
ACOs that would participate in
response to a HEBA, combined with
uncertainty regarding high spending
ACOs’ savings potential, results in a
wide range of potential impacts in total
over that 10 year period, from $2.3
billion in net savings at the 10th
percentile (that is, only 10 percent of
stochastic trials reduced Federal
spending by a greater magnitude than
$2.3 billion) to $1.2 billion in net
spending at the 90th percentile.
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TABLE 132: Projected Impact of Proposed Health Equity Benchmark Adjustment ($ Millions;
Negative Values Represent Savings to the Program)
2025
Impact
Estimate
Estimate ..
R!Ui
•.
2026
20
2027
20
2028
30
2029
2030
20
2031
-20
-60
2032
2033
-IOO
-120
2034
Total
-320
-120
l;lt . .
Law..... •.
\·. >
•.·. Estimate •
.(lqth .
•Pl:lrcentile •..
High
. Estimate ..
(9Qth
•.•.• ~40
--
>
.•......··•
50
flercentlle
•... ·.
••••• 70
For the proposed calculation
methodology to account for the impact
of improper payments in recalculating
expenditures and payment amounts
used in Shared Savings Program
financial calculations, upon reopening a
payment determination pursuant to
§ 425.315(a) (described in section
III.G.7.c of this proposed rule), some
ACOs would selectively elect to request
reopening for a prior performance year.
As a result, we project at least some
degree of higher program spending for
increased shared savings payments (or
_-,-:''\
·.•·
',,:,,-_-
,,
•• i;Q\
90
reduced loss recoupments) in cases for
which CMS decides to reopen the
payment determination and issue a
revised initial determination to account
for the impact of improper payments.
However, because reopening would not
be limited to adjusting performance year
and benchmark year expenditures for
ACO assigned beneficiaries but would
also impact other potentially offsetting
calculations including regional and
national expenditure trends used to
update ACO benchmarks, and because,
in addition to the reopening, CMS
-'
,','
,'
18·0 ••. t ,20()
would also adjust the historical
benchmark calculated for a potential
subsequent agreement period, the
frequency of requests, and the net
impact of any given request, are likely
to be limited. The proposed reopening
policy is projected to increase program
spending by $60 million in total over
the 2025 to 2034 period, ranging from
$30 million at the 10th percentile to $90
million at the 90th percentile, as shown
in Table 133.
TABLE 133: Projected Impact for Modifications to Specify the Calculation Methodology to
Account for Improper Payments in Recalculating Expenditures and Payment Amounts used in
Financial Calculations, Upon Reopening a Payment Determination($ Millions; Negative Values
Represent Savings to the Program)
2025
2026
2027
2028
2029
2030
2031
2032
2033
2034
Total
IO
0
0
0
0
IO
IO
IO
IO
IO
60
Impact
Estimate
Estimate·
. Rane:
.. Law ..
.Esthn~fo
•· .• ·.(10th •••
..
30
Petcentile· •. ·.
High
Estimate·.
(9Qth
•• 90
The proposed methodology for
excluding payment amounts for HCPCS
and CPT codes exhibiting SAHS billing
activity, as described in section III.G.7.d
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of this proposed rule, is anticipated to
be utilized only in rare and extreme
cases where a number of criteria are
satisfied, including that the level of
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billing represents a significant claims
increase representing a deviation from
historical utilization trends that is
unexpected and not clearly attributable
E:\FR\FM\31JYP2.SGM
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EP31JY24.179
Note: Projections at the 10th and 90 th percentile are shown in aggregate but not at the annual level because scenarios
contributing to the high estimate projection generally involve elevated spending in a limited number of years rather
than consistently higher spending across the projection period.
EP31JY24.178
lotter on DSK11XQN23PROD with PROPOSALS2
• Percentile)
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Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
to reasonably explained changes in
policy or the supply or demand for
covered items or services during a
limited time period. Even in cases
where CMS may apply the adjustment
to Shared Savings Program calculations
for SAHS billing activity (if finalized),
for CY 2024 or subsequent calendar
years, there is no expectation that it
would necessarily increase or decrease
overall shared savings or shared losses
because the policy would be applied
systematically across all ACOs in the
Shared Savings Program in a method
that adjusts both performance year and
benchmark year expenditures for ACO
assigned beneficiaries and regional and
national expenditures used in
benchmark calculations. However, this
policy would have the benefit of
reducing potential costs generated by
selective reopening requests under the
reopening proposal, because it would
prevent extreme cases of SAHS billing
activity from injecting variation in the
distribution of ACO shared savings and
loss calculations which could lead to an
elevated number of selective reopening
requests from ACOs predicting that
reopening would improve their
financial outcome. For this reason,
without the proposal to adjust Shared
Savings Program calculations for SAHS
billing activity during CY 2024 or
subsequent calendar years, the
estimated impact shown in Table 133
would have included between $100 to
$300 million in additional projected
spending from selective reopening
requests.
We estimate that there would be no
additional program expenditures
stemming from the implementation of
the prepaid shared savings payment
option, which we proposed to provide
eligible ACOs with additional cash flow
to encourage their investment in
activities that could potentially reduce
costs for the Medicare program and
beneficiaries and improve the quality of
care furnished to their assigned
beneficiaries. Any risk of higher
program spending as a result of
finalization of our prepaid shared
savings proposal would be fully
mitigated by the fact that eligibility
would be limited to ACOs that CMS
estimates are most likely to earn shared
savings, and any prepaid shared savings
payments an ACO receives would have
to be repaid to CMS. CMS would be
protected by the ACOs’ repayment
mechanisms in the event that an ACO
does not earn shared savings or cannot
otherwise repay the amount owed to
CMS. On the other hand, there is a high
degree of uncertainty regarding whether
(a) a meaningful number of ACOs would
choose this option given the
requirements for how prepayments must
be spent, and (b) the potential impact (if
any) that participation in this option
would have on the cost of care.
As to this uncertainty, our analysis
assumed that up to 30 ACOs would opt
to receive prepaid shared savings per
year (with the probability distribution
skewed toward zero participants), with
a 33 percent chance that ACOs receiving
prepaid shared savings would respond
by reducing spending for assigned
beneficiaries by between 0 to 2
percentage points (with the probability
distribution skewed toward zero impact)
as compared to their current spending
on assigned beneficiaries.817 This
projection accounts for annual prepaid
shared savings (offset by eventual
recoupments and/or repayments) of
roughly $2 million per ACO
participating in the payment option.
The associated impact on ACO spending
was projected to be nominal. Both at the
mean and at the 90th percentile the
projected net impacts on Medicare
spending round to zero. At the 10th
percentile (the optimistic end of the
range), we project small net savings of
$20 million in total to the Medicare
Program over 10 years.
TABLE 134: Projected Impact for the Prepaid Shared Savings Option($ Millions; Negative Values
Represent Savings to the Program)
2025
2026
2027
2028
2029
2030
2031
2032
2033
2034
Total
0
0
0
0
0
0
0
0
0
0
0
Impact
E~m~
Estimate
Rane: •
Low
Estimate
(10th
Nrcentile
... Hign
Estimate
-20 .·
.··(9Qlh
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
requiring Shared Savings Program ACOs
to report the APP Plus quality measure
set beginning in performance year 2025,
that would incrementally grow to
comprise of 11 measures, consisting of
the 6 measures in the existing APP
quality measure set and 5 newly
proposed measures from the Adult
Universal Foundation measure set that
would be incrementally incorporated
817 The assumptions allow for a limited
possibility that performance by ACOs receiving
prepaid shared savings could generate shared
savings comparable to the savings generated by
certain ACOs in the ACO Investment Model. Abt
Associates, Evaluation of the Accountable Care
Organization Investment Model, Final Report
(September 2020), available at https://
www.cms.gov/priorities/innovation/data-andreports/2020/aim-final-annrpt.
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31JYP2
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lotter on DSK11XQN23PROD with PROPOSALS2
Percentll~
Q
Note: Projections at the 10th and 90 th percentiles are shown in aggregate but not at the annual level because scenarios
contributing to the $20 million savings at the 10th percentile are too small to round above zero in any given year.
62183
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
into the APP Plus quality measure set
over performance years 2025 through
2028; focusing the collection types
available to Shared Savings Program
ACOs for reporting the APP Plus quality
measure set to all payer/all patient
eCQMs and Medicare CQMs; requiring
Shared Savings Program ACOs that
report the APP Plus quality measure set
to report on all measures in the APP
Plus quality measure set, as applicable;
establishing a Complex Organization
Adjustment for Virtual Groups and APM
Entities, including Shared Savings
Program ACOs, when reporting eCQMs;
providing clarity and consistency in
provisions of the Shared Savings
Program regulations on calculation of
the ACO risk score growth cap in risk
adjusting the benchmark each
performance year and the regional risk
score growth cap in calculating the
regional component of the three-way
blended benchmark update factor; and
modifying beneficiary notification
requirements.
The combined impacts for all Shared
Savings Program proposals are shown in
Table 135.
scoring Medicare CQMs using flat
benchmarks in their first 2 performance
periods in MIPS; and promoting the
adoption of eCQMs by extending the
eCQM reporting incentive. Additional
proposed changes include permitting
continued participation by ACOs whose
number of assigned beneficiaries falls
below 5,000 during their agreement
period; ensuring clarity of provisions on
application procedures; revisions to the
definition of primary care services
under § 425.400(c) for purposes of
beneficiary assignment; refining
advance investment payment policies;
TABLE 135: Projected Impact of Medicare Shared Savings Program Proposals (Individually
Shown in Tables 132, 133 and 134) ($ Millions; Negative Values Represent Savings to the Program)
2025
2026
2027
2028
2029
2030
2031
30
20
30
20
10
-10
-50
Impact
Estimate
Estimate
RaA ~; ...... •
·. Low ..
2032
-90
..
''\
:'i
,\'
~2q
;;49.
,,,,'
,.9Q
·330
-:--
...
2033
2034
Total
-110
-110
-260
..
'-':-,'•
,,_,
..
,,::-,,._
..
••.
.410
..
·•.
~480
..
.•
..
..
,$30 .• ~2,260
Estimate
(10th·........
.......
Percen.tlle ••
lotter on DSK11XQN23PROD with PROPOSALS2
b. Compliance With Requirements of
Section 1899(i)(3) of the Act
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 proposal to allow ACOs to
receive prepaid shared savings as
described in section III.G.5 of this
proposed rule; the proposal to use a
calculation methodology to account for
the impact of improper payments in
recalculating expenditures and payment
amounts for certain Shared Savings
Program financial calculations, upon
reopening an ACO’s payment
determination and issuing a revised
initial determination pursuant to
§ 425.315(a) as described in section
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III.G.7.c of this proposed rule; the
proposal to use a methodology for
certain Shared Savings Program
calculations to mitigate the impact of
SAHS billing activity occurring in CY
2024 or subsequent calendar years, as
described in section III.G.7.d of this
proposed rule; and the proposed
technical changes to the provision
describing how we calculate the weights
applied when capping growth in
regional risk scores as part of the
regional component of the three-way
blended benchmark update factor, as
described in section III.G.7.f of this
proposed rule. When considered
together these proposed 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
particularly in serving medically
complex, high-cost populations in
underserved communities, and
promoting integrity and fairness and
ensuring the accuracy of Shared Savings
Program financial calculations. These
proposed changes are not expected to
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result in a situation in which the
payment methodology under the Shared
Savings Program, including all policies
proposed to be 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 policies finalized by
that final rule would result in $4.9
billion in greater program savings
compared to a hypothetical baseline
payment methodology that excluded the
policies that required section 1899(i)(3)
of the Act authority (see 87 FR 70195
and 70196). The marginal impact of the
proposed changes in the CY 2024 PFS
final rule were estimated to lower net
spending by $330 million over the
subsequent ten-year period for all new
policies combined, including the cap an
ACO’s regional service area risk score
growth, the addition of a new third step
to the beneficiary assignment
methodology, and the revised approach
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to identify the assignable beneficiary
population (88 FR 79496). The marginal
impact of the proposed changes in this
proposed rule are estimated to lower net
spending by an additional $260 million
in total through 2034. Although the
provisions in this proposed rule that
require section 1899(i) of the Act
authority are estimated to increase
spending by only $60 million over 10
years, the cumulative impact of all
policies (including those in this
proposed rule) are estimated to result in
more than $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. Therefore, we estimate that
the implementation of the proposals
made in this proposed rule would not
be greater than those that would result
under the statutory payment model,
consistent with 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. Additional
Shared Savings Program data beginning
to accumulate after the end of the
COVID–19 public health emergency,
along with emerging information on the
characteristics of new entrants in the
Shared Savings Program for agreement
periods beginning on January 1, 2024
and January 1, 2025, are anticipated to
gradually improve our ability to
reevaluate program impacts in a
comprehensive fashion. 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.
12. Medicare Part B Payment for
Preventive Services
In section III.H.2. of this proposed
rule, based on the proposals in section
III.M of this proposed rule, we propose
to clarify that a physician’s order is no
longer required for the administration of
a hepatitis B vaccine in Part B, which
would facilitate roster billing by mass
immunizers for hepatitis B vaccine
administration. We also propose that
payment for hepatitis B vaccines and
their administration be made at 100 of
reasonable cost in RHCs and FQHCs,
separate from the FQHC PPS or the RHC
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All-Inclusive Rate (AIR) methodology,
in order to streamline payment for all
Part B vaccines in those settings. We
believe that Medicare spending impacts
from both of these proposals will be
negligible, as hepatitis B vaccines are
already available to all Medicare
enrollees under either Part B or Part D.
While we believe that there will be an
uptake of hepatitis B vaccines under
Part B as shifted from Part D, we believe
that this impact on the Part B program
will be negligible for several reasons,
including the fact that a portion of
current beneficiaries have already
received the hepatitis B vaccine through
either Part B or Part D, and since a
significant number of individuals will
likely receive this vaccine by the time
they are Medicare age due to current
CDC recommendations (please see
section III.M of this proposed rule for
more information).
In section III.H.3. of this proposed
rule, we propose a fee schedule for
Drugs Covered as Additional Preventive
Services (DCAPS), per section
1833(a)(1)(W)(ii) of the Act. We also
propose payment limits for supply and
administration fees for DCAPS drugs
that are similar to those fees for drugs
paid under the ASP payment
methodology set forth in section 1847A
of the Act, and we propose payment
limits for DCAPS drugs and any supply
and administration fees in RHCs and
FQHCs according to this same fee
schedule. We believe impacts from
these proposed policies will be minimal
as well. While no drugs are currently
covered as DCAPS, DCAPS drugs are
likely to be covered under Part D before
coverage under the Part B additional
preventive services benefit would
commence.
13. Impact of Provisions for Medicare
Prescription Drug Inflation Rebate
Program
We are proposing regulations in
section III.I. to codify existing policies
established in program guidance as well
as revised and new policies to
implement the Medicare Part B Drug
Inflation Rebate Program, including the
requirement for manufacturers to pay
rebates for certain single source drugs
and biological products with prices that
increase faster than the rate of inflation;
criteria for the identification of Part B
rebatable drugs; computation of the
beneficiary coinsurance adjustment for
Part B rebatable drugs; determination of
the rebate amount for Part B rebatable
drugs; reduction of the rebate amount
for Part B rebatable drugs in shortage
and when there is a severe supply chain
disruption; provision of reports to each
manufacturer of a Part B rebatable drug;
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and establishment of enforcement
provisions via civil money penalties.
Additionally, we are proposing
regulations in section III.I. to codify
existing policies established in program
guidance as well as revised and new
policies to implement the Medicare Part
D Drug Inflation Rebate Program,
including the requirement for
manufacturers to pay rebates for certain
Part D drugs and biological products;
criteria for the identification of Part D
rebatable drugs; determination of the
rebate amount for Part D rebatable
drugs; reduction of the rebate amount
for shortages and when there is a severe
supply chain disruption or likely
shortage; provision of reports to each
manufacturer of a Part D rebatable drug;
and establishment of enforcement
provisions via civil money penalties.
We do not expect these proposals to
have a material impact on inflation
rebates. The majority of proposals
codify existing guidance. Proposed new
policies or changes to existing policies
in guidance are technical provisions
that we do not expect to have a material
impact on the calculation of total
rebates in aggregate.
As discussed in section III.I. of this
proposed rule, for Part D drug inflation
rebates, we are proposing to implement
section 1860D–14B (b)(1)(B) of the Act
which requires the Secretary to exclude
340B units from the total number of
units used to calculate the total rebate
amount owed by a manufacturer,
beginning on January 1, 2026. For the
first three quarters of 2026, we are
proposing use an estimation policy that
would remove a percentage of units
from the total number of units used to
calculate the total rebate amount to
remove 340B units from Part D drug
inflation rebate calculations. That
percentage would be equal to the total
number of units purchased under the
340B Drug Pricing Program for an NDC–
9, divided by the number of total units
sold of that NDC–9.
CMS does not currently have data on
340B claims for the Part D program or
at the drug level in general, which
prevents CMS from quantifying the
impact of this provision. While we
expect that the exclusion of 340B units
from Part D inflation rebates will reduce
the amount of rebates collected through
this program, the magnitude of this
reduction is unknown due to the lack of
data on 340B claims for the Part D
program. The use of a temporary
estimation policy will allow CMS to
implement the exclusion of 340B units
from Part D inflation rebates by January
2026. It also alleviates the burden from
interested parties to modify existing
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processes to provide 340B claims
information.
14. Expand Colorectal Cancer Screening
In section III.K. of this rulemaking we
propose to update and expand coverage
for CRC screening by (1) removing
coverage for the barium enema
procedure in regulations at § 410.37, (2)
adding coverage for the CT
colonography procedure in regulations
at § 410.37, and (3) expanding a
‘‘complete colorectal cancer screening’’
in § 410.37(k) to include a follow-on
screening colonoscopy after a Medicare
covered blood-based biomarker CRC
screening test (described and authorized
in NCD 210.3) returns a positive result.
We do not anticipate our proposal to
remove coverage for the barium enema
procedure to result in a significant
financial impact on the Medicare
program. An internal claims analysis
found that Medicare Fee for Service
only paid 62 claims for the screening
barium enema procedure in calendar
year 2021 and only 72 claims for the
screening barium enema procedure in
calendar year 2022.
We do not anticipate our proposal to
add coverage for the CTC procedure for
CRC screening to result in a significant
financial impact on the Medicare
program. CTC could be an appropriate
option for patients and clinicians who
seek a direct visualization procedure as
a first step in CRC screening that is less
invasive and less burdensome on the
patient (including those who are
medically fragile or have complex or
usual anatomy) compared to Screening
Colonoscopy. We expect that patients
will most often choose CTC as an
alternative to colonoscopy for CRC
screening and that future increased
utilization of CTC will be balanced, in
part, by avoided screening
colonoscopies. Our goal is that the
patient and their clinician make the
most appropriate choice in CRC
screening, which includes
considerations of the risks, burdens and
tradeoffs for each covered test or
procedure. We expect that utilization of
CTC for CRC screening will be modest,
especially considering that CTC requires
bowel preparation and travel to an
outpatient clinical services site (similar
to a colonoscopy) and also considering
the availability of non-invasive stoolbased tests that can be administered at
home and mailed to a lab. A 2015 study
titled ‘‘Medicare cost of colorectal
cancer screening: CT colonography vs.
optical colonoscopy’’ concluded that
CTC is 29 percent less expensive than
colonoscopy (accounting for related
procedures) for the Medicare population
in the base scenario. Although the CTC
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cost advantage is increased or reduced
under alternative scenarios, it is always
positive.818
We do not anticipate our proposal for
expanding a ‘‘complete colorectal
cancer screening’’ in § 410.37(k) to
include a follow-on screening
colonoscopy after a Medicare covered
blood-based biomarker CRC screening
test returns a positive result to produce
a significant financial impact on the
Medicare program. We expect that
patients will choose either a stool-based
test or a blood-based biomarker test for
a non-invasive first option in CRC
screening and that patients who choose
a blood-based biomarker test within the
context of a complete colorectal cancer
screening under our proposal will be
offset, in part, by the avoided utilization
of a stool-based test.
In conclusion, we anticipate that our
proposal to update and expand coverage
for CRC screening will result in some
additional utilization, but that
additional utilization will be balanced,
in part or in whole, by avoided
utilization of alternative types of tests as
well as benefits and savings resulting
from increased prevention and early
detection (allowing for less invasive and
more effective treatment).
15. Requirement for Electronic
Prescribing for Controlled Substances
for a Covered Part D Drug Under a
Prescription Drug Plan or an MA–PD
Plan
In section III.L of this proposed rule,
we propose one update to the CMS
EPCS Program. We are proposing that
prescriptions written for a beneficiary in
a LTC facility would not be included in
determining compliance under the CMS
EPCS Program until January 1, 2028,
and that compliance actions against
prescribers who do not meet the
compliance threshold based on
prescriptions written for a beneficiary in
a LTC facility would commence on or
after January 1, 2028. Without this
provision, if we keep the existing date
of January 1, 2025, as in the current
regulatory text at § 423.160(a)(5) for the
CMS EPCS Program, we estimate at least
6,800 prescribers would become noncompliant due to CMS including
prescriptions written for beneficiaries in
LTC in the CMS EPCS Program
compliance threshold calculation. This
estimate is based on data from calendar
year 2022 and is prior to considering
emergency and disaster exceptions and
waivers, which could reduce these
818 Pyenson, B., Pickhardt, P.J., Sawhney, T.G. et
al. Medicare cost of colorectal cancer screening: CT
colonography vs. optical colonoscopy. Abdom
Imaging 40, 2966–2976 (2015). https://doi.org/
10.1007/s00261-015-0538-1.
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62185
numbers. This proposal, should we
finalize it, would allow prescribers
additional time to adopt the new eprescribing standard, NCPDP SCRIPT
standard version 2023011, and utilize
EPCS. Additionally, this proposal
would prevent an increased number of
prescribers from potentially applying for
a waiver for circumstances beyond their
control due to difficulty of reliably
conducting EPCS for beneficiaries in
LTC facilities by the current deadline of
January 1, 2025.
We do not believe this proposal
would cause additional costs as we are
only extending the deadline by which
we would include prescriptions written
for patients in LTC facilities in the CMS
EPCS Program compliance threshold
calculation and not modifying the
requirement to become compliant. We
also note that beneficiaries in LTC
facilities may not receive the full
benefits of EPCS, which we describe in
the CY 2022 PFS final (86 FR 65362),
until a later date, but we believe the
delay is necessary due to the logistical
challenges of prescribers electronically
prescribing controlled substances
prescriptions for beneficiaries in LTC
facilities.
We seek public comments on our
impact assumptions.
16. Expand Hepatitis B Vaccine
Coverage
In section III.M. of this rulemaking,
we propose to expand Hepatitis B
vaccine coverage by revising our
regulatory definition for intermediate
risk groups by adding a new paragraph
to include individuals who have not
previously received a completed
hepatitis B vaccination series or whose
vaccination history is unknown
(§ 410.63(a)(2)).
Hepatitis B vaccine is currently
covered under Medicare Part B for
enrollees who are at intermediate or
high risk of contracting hepatitis B
virus, and, for Part D enrollees who do
not fall into those categories the vaccine
may be covered under Medicare Part
D.819 In 2021, about 51 million of 65
million Medicare beneficiaries were
enrolled in Part D and 21,629 received
the vaccine. In 2019, Part B covered
300,000 doses of hepatitis B vaccine for
beneficiaries who were at high or
819 Sayed, BA, Finegold, K, Ashok, K, Schutz, S,
De Lew, N, Sheingold, S, Sommers, BD. Inflation
Reduction Act Research Series: Medicare Part D
Enrollee Savings from Elimination of Vaccine CostSharing. (Issue Brief No. HP–2023–05). Office of the
Assistant Secretary for Planning and Evaluation,
U.S. Department of Health and Human Services.
September 2023. Retrieved from https://
aspe.hhs.gov/sites/default/files/documents/
407d41b6534e7af6702eb280b3945d00/aspe-iravaccine-part-d.pdf.
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intermediate risk for the disease.820
Since the vaccine has been available for
several decades, we are not able to
determine how many Medicare
beneficiaries have already received the
vaccine.
Overall vaccination rates among
adults, including older adults, are
generally low.821 822 A Centers for
Disease Control and Prevention (CDC)
analysis of data from the National
Health Interview Survey found that
fewer than half of all adults (less than
45 percent) received age-appropriate
recommended vaccinations in 2019.823
An estimated 20 percent of adults aged
≥60 years have been vaccinated against
hepatitis B; and approximately 34
percent of adults aged ≥19 years have
been vaccinated against hepatitis B.824
We do not anticipate our proposal to
result in significant economic impact on
the Medicare program.
As of January 1, 2023, the Inflation
Reduction Act (IRA) eliminated out-ofpocket costs for vaccines covered under
Medicare Part D that are recommended
by the Advisory Committee on
Immunization Practices (ACIP).825
Before the Inflation Reduction Act
(IRA), beneficiaries incurred out of
pocket costs for Part D vaccines. While
we would expect that after the IRA,
more beneficiaries would receive
covered vaccines because of eliminating
820 Medpac 2021. Report to the Congress:
Medicare and the Health Care Delivery System.
Chapter 7. Medicare vaccine coverage and payment.
Retrieved from https://www.medpac.gov/wpcontent/uploads/import_data/scrape_files/docs/
default-source/default-document-library/jun21_
ch7_medpac_report_to_congress_sec.pdf.
821 CDC. (2022, February 17). Vaccination
Coverage among Adults in the United States,
National Health Interview Survey, 2019–2020.
Centers for Disease Control and Prevention.
Retrieved February 27, 2023, from https://
www.cdc.gov/vaccines/imz-managers/coverage/
adultvaxview/pubs-resources/vaccination-coverageadults-2019-2020.html.
822 Gellin, B.G., Shen, A.K., Fish, R., Zettle, M.A.,
Uscher-Pines, L., & Ringel, J.S. (2016). The National
Adult Immunization Plan: Strengthening Adult
Immunization Through Coordinated Action.
American journal of preventive medicine, 51(6),
1079–1083. https://doi.org/10.1016/
j.amepre.2016.04.014.
823 CDC. (2022, February 17). Vaccination
Coverage among Adults in the United States,
National Health Interview Survey, 2019–2020.
Centers for Disease Control and Prevention.
Retrieved February 27, 2023, from https://
www.cdc.gov/vaccines/imz-managers/coverage/
adultvaxview/pubs-resources/vaccination-coverageadults-2019-2020.html.
824 CDC. 2023. Vaccination Coverage among
Adults in the United States, National Health
Interview Survey, 2021. Retrieved from https://
www.cdc.gov/vaccines/imz-managers/coverage/
adultvaxview/pubs-resources/vaccination-coverageadults-2021.html#:∼:text=Hepatitis%20B%20
vaccination%20coverage%20in,and%20Other%20
(40.2%25)%20adults.
825 Sayed, BA, et al. 2023. Inflation Reduction Act
Research Series.
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out of pocket costs, existing research
shows that cost-sharing is only one
factor among other determinants. Trust
in vaccines, access to health care, health
literacy, perceived risk, sociodemographic factors and awareness of
vaccine recommendations, all shape
whether individuals obtain a
recommended vaccine.826 If the number
of people receiving the hepatitis B
vaccine under Part D is any indication,
we assume that even by increasing
access, there will not be immediate or
significant change in the number of
covered hepatitis B vaccines paid under
Medicare Part B. For these reasons, we
do not anticipate that expanding the
definition of intermediate risk for
hepatitis B vaccine will result in a
significant financial impact to the
Medicare Program.
17. Low Titer O+ Whole Blood
Transfusion Therapy During Ground
Ambulance Transport
As discussed in section III.N of this
proposed rule, we propose to modify the
definition of ALS2 at § 414.605 by
adding the administration of low titer
O+ whole blood transfusion therapy
(WBT) to the list of ALS2 procedures as
a new number 8. We would also reflect
this change in the Medicare Benefit
Policy Manual, Chapter 10, Ambulance
Services, section 30.1.1, Definition of
Ground Ambulance Services. Under this
proposal, a ground ambulance transport
that provides WBT would itself
constitute an ALS2-level transport.
We believe that many ground
ambulance transports providing WBT
already qualify for ALS2 payment, given
that patients requiring such transfusions
are generally critically injured or ill and
often suffering from cardio-respiratory
failure and/or shock and are therefore
likely to receive one or more procedures
currently listed as ALS procedures in
the definition of ALS2, such as
endotracheal intubation, central venous
line, chest decompression, and
placement of an intraosseous line. For
impact analysis, for ground ambulance
transports that provide WBT only and
currently do not qualify for ALS2
payment, we are assuming that these
transports are reported as ALS1
(advanced life support, level 1)
emergencies.
In order to help identify the number
of ground ambulance transports that
could potentially be affected by this
proposal, we analyzed inpatient
hospital claims related to multipletrauma that started with an ALS1
emergency ambulance transport and
826 Sayed, BA, et al. 2023. Inflation Reduction Act
Research Series.
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also included a blood transfusion done
in the hospital. The inpatient
admissions were identified by DRG code
‘‘813’’ and diagnosis code of ‘‘24,’’ the
ambulance transport is identified by
HCPCS ‘‘A0427,’’ and the blood
transfusion administered to these
patients in the hospital setting is
identified by the presence of covered
charges, patient liability amounts, and
replacement units for blood.
Since payments vary for urban, rural,
and super-rural ground ambulance
transports, we calculated the average
Medicare payment amount for ALS2
(HCPCS A0433) and ALS1 (HCPCS
A0427) over the last several years. The
average payment differential over
calendar years 2019 and 2023 is
estimated to be roughly $162 per
transport. It is difficult to make an
assumption for the number of transports
that will be impacted by this proposal,
but the potential number over the last
several years, based on an analysis of
actual experience, is very few. Even if
all of these ALS1 emergency transports
shifted to being ALS2 transports, which
is very unlikely, the impact would be
negligible.
18. Updates to the Quality Payment
Program
In this section of this proposed rule,
we estimated the overall and
incremental impacts of the Quality
Payment Program policies. We
estimated participation, final scores,
and payment adjustment for eligible
clinicians participating through
traditional MIPS, MVPs, and the
Advanced APMs. We also presented 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.
A. Overall MIPS Modeling Approach
and Data Assessment
(1) MIPS Modeling Approach
For this proposed rule, we used a
similar modeling approach as the CY
2024 PFS final rule (88 FR 79504
through 79506). We created two MIPS
RIA models: a baseline and proposed
policy model. Our baseline model
includes previously finalized policies
that will be in effect for the CY 2024
performance period/2026 MIPS
payment year in the absence of any of
the newly proposed policies in this
proposed rule. Examples of previously
finalized policies included in the
baseline model include: updated QP
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and partial QP thresholds, and the
previously finalized list of MVPs.
The proposed policies model builds
off the baseline model and incorporates
the MIPS policies for the CY 2025
performance period/2027 MIPS
payment year included in this proposed
rule. By comparing the baseline model
to the proposed policies model, we are
able to estimate the incremental impact
of the specific policies in this proposed
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. These
limitations of our model are discussed
later in this RIA.
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(2) Data Used To Estimate Future MIPS
Performance
In the CY 2024 PFS final rule (88 FR
79504), we explained our decision to
use CY 2022 performance period
submissions data. We noted that using
CY 2022 performance data presents the
most current data and aligns our
participation, final scoring, and
payment adjustment analysis around the
same common data set. CY 2022
performance data were the most
recently available data in time for us to
construct our simulation model for this
proposed rule and for the same reasons
discussed in the CY 2024 PFS final rule
(88 FR 79504), we are considering it to
construct the baseline and proposed
policies model in this proposed rule. As
more data becomes available, we will
assess the feasibility and validity of that
data for use in RIA simulations.
b. 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
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
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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,
there are two separate PFS CFs—one for
eligible clinicians who are QPs for the
year (the qualifying APM CF), and the
other for all non-QP eligible clinicians
and other suppliers paid under the PFS
(the non-qualifying APM CF). The
update to the qualifying APM CF for a
year is 0.75 percent, while the update to
the non-qualifying APM CF for a year is
0.25 percent.
In addition, the thresholds to achieve
QP status beginning in the 2025 QP
Performance Period will increase to 75
percent for the payment amount
method, and 50 percent for the patient
count method. Overall, we estimated
that for the 2025 QP Performance Period
between 339,561 and 436,579 eligible
clinicians will become QPs, and
therefore be excluded from MIPS
reporting requirements and payment
adjustments.
In section IV.A.4.k.(2) of this
proposed rule, we propose to modify the
definition of ‘‘attribution-eligible
beneficiary’’ 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 evaluation and management
(E/M) services as the default attribution
basis, we also would eliminate the need
to develop customized attribution bases
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62187
for Advanced APMs that do not use E/
M services as the basis for attribution.
Therefore, our proposal would
standardize the attribution methodology
for QP determinations by making
covered professional services the basis
for attribution across all Advanced
APMs.
We projected the number of eligible
clinicians who 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 2025 QP Performance Period,
as well as some Advanced APMs
anticipated to be operational during the
2025 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 2025 QP Performance
Period:
• Bundled Payments for Care
Improvement Advanced Model;
• 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); and
• Enhancing Oncology Model (EOM);
and
• Primary Care First (PCF) Model.
We used the Participation Lists and
Affiliated Practitioner Lists, as
applicable, (see § 414.1425(a) for
information on the APM Participant
Lists and QP determinations) for the
2023 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 2025 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 in the CY 2025 Performance
Period/2027 MIPS Payment Year
(1) Initial Population of Clinicians
Included in the RIA Baseline and
Proposed Policies Models
For this proposed rule, we applied the
same assumptions as in the CY 2024
PFS final rule (88 FR 79505) to estimate
our initial population of clinicians
based on CY 2022 performance period/
2024 MIPS payment year data.
We used the same CY 2022 final
reconciled eligibility determination file
described in the CY 2024 PFS final rule
(88 FR 79505). This file reconciles
eligibility from two determination
periods and aligns with the CY 2022
performance period submissions data on
which we based this model. Our
analysis included 1,820,899 clinicians
with PFS claims in this initial
population. This initial population of
clinicians was used to determine
eligibility using the methodology
described in the following sections.
(2) Estimated Number of MIPS Eligible
Clinicians After Applying Eligibility
Assumptions
lotter on DSK11XQN23PROD with PROPOSALS2
(a) Methods and Assumptions Used To
Estimate Eligibility
After identifying the clinician
population with PFS claims we applied
the same eligibility assumptions and
determination process described in the
CY 2024 PFS final rule (88 FR 79505).
We are not proposing any modifications
to MIPS eligibility requirements and the
same eligibility assumptions apply to
both the baseline and final policies
model.
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 MIPS payment adjustment.
We base this estimate on the CY 2022
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performance period data described in
this section of this proposed rule, which
includes the three low volume criteria.
Within this category we divide
clinicians into two groups- clinicians
who report data and clinicians who do
not report data.
Our next two eligibility assumptions
concern clinicians and groups who may
participate in MIPS but are not required
to participate. First, we estimate group
eligibility. These are the clinicians who
have a group submission and their
group exceeds the low-volume
threshold in all 3 criteria. Next, we
apply our opt-in eligibility assumptions.
Individuals or groups who exceed the
low-volume threshold in 1 criterion but
not all 3 may elect to opt-in. Based on
the CY 2022 data we determine which
individuals opted-in to MIPS and for the
purposes of our model estimate that
these clinicians will continue to opt-in
to MIPS.
After applying the process outlined in
this section of this proposed rule, we
next estimate the number of ‘‘Potentially
MIPS Eligible’’ clinicians. These
clinicians are not included in our total
number of MIPS eligible clinicians.
These are clinicians who are not MIPS
eligible individually but who may either
opt-in because they exceed the low
volume threshold in at least one
criterion but not all three or who could
report as part of a group which exceeds
all three low volume criteria.
Finally, we estimate the number of
clinicians who are neither MIPS eligible
nor potentially MIPS eligible. First, we
estimate the number of MIPS eligible
clinicians who are below all three lowvolume criteria (both as an individual
and as a group) again using the CY 2022
performance period data as described in
this section of this proposed rule.
Next, we estimate the number of QPs
(not MIPS eligible). In section
VII.E.17.b. of this proposed rule, we
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estimated a range of QPs. For the
purposes of our RIA population, we
estimate a specific number of QPs. This
is because it is necessary to establish a
specific population of clinicians to use
to simulate the impacts of our final
policies on participation, final scores,
and payment adjustments. Finally, we
estimate the number of clinicians who
are excluded for other reasons including
that they are a non-eligible clinician
type or newly enrolled in Medicare.
After applying these assumptions to
our initial population, we estimate
686,645 MIPS eligible clinicians with
$5.5 billion in allowed charges.
However, this number may be as high as
1,270,806 MIPS eligible clinicians and
$7 billion allowed charges if all
potentially MIPS eligible 827 clinicians
either opt-in or report as a group. This
is an unlikely scenario but it establishes
the full range of possible MIPS eligible
clinicians in our initial population.
(b) MIPS Eligibility Estimates
Eligibility among many clinicians is
contingent on submission to MIPS as a
group or election to opt-in: therefore, we
would not know the number of MIPS
eligible clinicians who submit until the
submission period for the CY 2023
performance period is closed. For the
remaining analysis, we use the
estimated population of 686,645 MIPS
eligible clinicians described in
previously in this section of this
proposed rule. Table 136 summarizes
our eligibility estimates for the proposed
policies model after applying our
assumptions discussed in this section of
this proposed rule.
827 We define potentially MIPS eligible clinicians
as those clinicians who are not required to
participate in 13MIPS but may either opt-in or join
a group that exceeds the low-volume threshold in
all three criteria.
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Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
TABLE 136: Description of MIPS Eligibility Status for CY 2025 Performance Period/2027 MIPS
Payment Year Using the CY 2025 PFS Proposed Rule Assumptions**
Predicted Participation
Status in MIPS Among
Clinicians *
Number of
Clinicians
PFS allowed
charges ($ in
mil~
Reported to MIPS
105,843
$29,530
Did not Report to MIPS
40,813
$11,951
Group eligibility
(only subject to payment adjustment because clinicians' groups Had a group submission
exceed low-volume threshold in all 3 criteria)
533,473
$13,108
6,516
$350
Eligibility Status
MIPS eligible
(always subject to a MIPS payment adjustment because
individual clinicians exceed the low-volume threshold in all 3
criteria)
MIPS eligible
Opt-In eligibility assumptions
(only subject to a positive, neutral, or negative adjustment
because the individual or group exceeds the low-volume
threshold in at least 1 criterion but not all 3, and they elect to
opt-in to MIPS)
Opted-in To MIPS
Total Number of MIPS Eligible Clinicians and the
associated PFS allowed char es
686,645
Potentially MIPS Eligible
(not subject to payment adjustment for non-participation; could
Opt-in Eligible; Do not opt-in
be eligible for one of two reasons: (1) meet group eligibility; or
(2) opt-in eligibility criteria)
Group Eligible; Did not
Potentially MIPS Eligible
Report
Below the low-volume threshold
(never subject to payment adjustment; both individual and group
Not applicable
is below all 3 low-volume threshold criteria)
Excluded for other reasons
(Non-eligible clinician type, newly enrolled)
Qualified Participant (QP)***
178,216
405,945
129,806
Not applicable
60,471
Not applicable
359,816
1,134,254
Total Number of Clinicians Not MIPS Eligible
1,820,899
Total Number of Clinicians (MIPS and Not MIPS Eligible)
$5,517
$9,502
$795
$501
$17,602
$33,916
$88,481
d. Modeling Approach and Methods for
MIPs Value Pathways (MVPs) and
Traditional MIPS
(1) Summary of Approach
In this proposed rule, we present
several proposals which impact the
measures and activities, the
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performance category scores, final score
calculation, and the MIPS payment
adjustment of MIPS eligible clinicians.
We outline these changes in more detail
in section VII.E.17.d.(3). Of this
proposed rule as we describe our
methodology to estimate MIPS payment
adjustments for the CY 2025
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performance period/2027 MIPS
payment year. We then present the
impact of the proposed policies in the
CY 2025 performance period/2027 MIPS
payment year and compare select
metrics to the baseline model. By
comparing the baseline model to the
policies model, we are able to estimate
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lotter on DSK11XQN23PROD with PROPOSALS2
* Participation excludes facility-based clinicians who do not have scores in the 2022 MIPS submission data.
** Allowed charges estimated in 2022 dollars. Low-volume threshold is calculated using allowed charges. MIPS payment adjustments
are applied to the paid amount.
*** Our QP estimate differs from that reported in section Vll.E.17.b of this proposed rule because, for purposes of establishing the
population used in our modeling, we estimate an absolute number of QPs rather than a range.
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the incremental impact of the policies
for the CY 2025 performance period/
2027 MIPS payment year.
MIPS eligible clinician’s final scores
are 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 in the four MIPS
performance categories as an individual,
group, virtual group, APM Entity,
clinicians participating in MIPS through
the APM Performance Pathway (APP),
or through an MVP. 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. Our
simulation applies the proposed and
previously finalized policies to the
existing MIPS scoring engine.
In the CY 2022 PFS final rule (86 FR
65394 through 65397), we finalized
policies at § 414.1365 for implementing
MIPS Value Pathways beginning in the
CY 2023 performance period/2025 MIPS
payment year. We incorporate MVP
participation and scoring rules in this
RIA where applicable as described in
the following section.
(2) Methodology To Assess Impact for
MIPS Value Pathways
lotter on DSK11XQN23PROD with PROPOSALS2
(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. We
assessed whether to use CY 2024 MVP
registration data to estimate MVP
participation but elected to again use
the approach described in the CY 2024
PFS final rule (88 FR 79507) for two
reasons. First, we do not presently have
MVP scoring data, thus do not know the
information of MVP registrants that may
submit MVP data to MIPS. Secondly,
our model is based on CY 2022
performance data. This data does not
contain MVP scores and reconciliation
between multiple years introduces
uncertainty and complexity into our
model. As MVP scoring data becomes
available in the future, we will reassess
our methodology for estimating MVP
participation and final scores.
We assume for purposes of this
model, that MVP Participants are MIPS
eligible individual clinicians or groups
that submit the required MVP measures.
For the baseline model, we used the
measures from the 16 MVPs finalized in
the CY 2024 PFS final rule Appendix 3
(88 FR 79978 through 80047).
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In section IV.A.4.a. and Appendix 3 of
this proposed rule, we propose
modifications to 7 existing MVPs and
proposed 6 new MVPs. The 6 new
proposed MVPs are:
• Complete Ophthalmologic Care
• Dermatological Care
• Gastroenterology Care
• Optimal Care for Patients with
Urologic Conditions
• Pulmonology Care
• Surgical Care
For the proposed policies model, we
incorporated the measure revisions for
the existing MVPs described in
Appendix 3 of this proposed rule. Due
to data availability, we are unable to
simulate scores for the following
measures: 487, 488, 489, 490, 492, 493,
496, 497, 502, 503, 504, 505, ABG44,
PIMSH13, UREQA10, 485, 486, 487,
488, 489, 490, 492, 493, 495, 496, 497,
499, 500, 501, 502, 503, 504, 505,
AAD16, AAD17, AAD18, ABG44,
GIQIC26, IA_PM_XX, IRIS61, MSK6,
MSK7, MSK8, MSK9, MUC2023–141,
MUC2023–161, MUC2023–162,
MUC2023–190, MUC2023–211,
PIMSH13, UREQA10.
For these MVP Participants, we
calculate both an MVP and a traditional
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).
Our MVP Participant assumptions
have limitations: the measure list used
to simulate MVP participation does not
align completely with what is proposed
in section IV.A.4.a. of this proposed
rule, 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 (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 2022 performance period (upon
which our model is based). Therefore,
we scored any improvement activities
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the MVP Participants submitted in 2022
as if those improvement activities are in
the MVP inventory. Additionally, in
section IV.A.4.b.(1)(b) of this proposed
rule, we proposed to score all available
population health measures for a
clinician participating in an MVP and
select the highest scoring of those
measures for use in determining their
category score. We incorporated this
proposal into our simulation.
(3) Methodology To Assess Impact for
Traditional MIPS
To estimate the impact of the policies
on MIPS eligible clinicians, we
generally used the CY 2022 performance
period’s data, including data submitted
or calculated for the quality, cost,
improvement activities, and Promoting
Interoperability performance categories.
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 2025
performance period/2027 MIPS
payment year for the baseline and
policies scoring models for each MIPS
eligible clinician using score estimates
for quality, cost, Promoting
Interoperability, and improvement
activities performance categories, and
the application of our final scoring
policies.
(a) Methodology To Estimate the Quality
Performance Category Score
We used the CY 2024 PFS final rule
final policies model as the starting point
of our baseline model. Since there are
no previously finalized policies
impacting the quality performance
category that were not already included
in the CY 2024 PFS final rule policies
model, we did not make any
modifications to the quality
performance category and the baseline
model is identical to the CY 2024 PFS
final rules policies model with respect
to the quality category.
Our proposed policies model
incorporates the following proposals
from this proposed rule as outlined in
section IV.A.4.e.(1) of this proposed
rule:
In section IV.A.4.f.(1)(b)(i) of this
proposed rule, to facilitate fairer
scoring, we propose to remove the
scoring cap and change the
benchmarking approach for certain
topped out measures applicable to
clinicians facing both limited measure
choice and limited scoring
opportunities. We did not simulate the
addition of quality measures described
in section IV.A.4.e.(1)(d)(i) since we use
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existing quality measure data from the
CY 2022 performance period which
does not include new measures. We do
not simulate the removal of quality
measures described in section
IV.A.4.e.(1)(d)(ii) since we cannot
predict how clinician behavior and
measure selection would change in
response.
lotter on DSK11XQN23PROD with PROPOSALS2
(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
the CY 2024 PFS final rule (88 FR
79508) for the baseline and the
proposed policies RIA models with the
modifications described below.
For this proposed rule, the baseline
policies RIA model used the same
methodology as the final policies RIA
model in the CY 2024 PFS final rule (88
FR 79508). The proposed policies RIA
model incorporated and implemented
the following changes:
• In section IV.A.4.e.(2)(a) of this
proposed rule, we are proposing to
adopt 6 new episode-based cost
measures and modify 2 existing
episode-based cost measures . We
incorporated measure test data with the
specifications for the new and modified
measures.
• In section IV.A.4.f.(1)(d) of this
proposed rule, we are proposing to
modify our cost scoring methodology.
The median cost for a measure would be
assigned achievement points equal to 10
percent of the performance threshold
(7.5 in the CY 2024 performance period/
CY 2026 payment year). The cut-offs for
benchmark ranges would be calculated
as standard deviations from the median.
This proposal is incorporated into our
model based on the specifications
explained in section IV.A.4.f.(1)(d)(ii)(B)
of this proposed rule.
(c) Methodology To Estimate the
Promoting Interoperability Performance
Category Score
We estimated Promoting
Interoperability performance category
score by using the same methodology
that we used in the CY 2024 PFS final
rule (88 FR 79508). We did not
incorporate any changes to this category
in our model. In section IV.A.4.e.(4)(f) of
this proposed rule, we are proposing
minimum criteria for a qualifying data
submission for the Promoting
Interoperability performance category.
We conducted an analysis of this
proposal and determined that the
impact on final scores and payment
adjustments was negligible and
therefore did not incorporate it into our
model.
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(d) Methodology To Estimate the
Improvement Activities Performance
Category Score
For the baseline and policies model
we used the same method to estimate
the improvement activities performance
category score as described in the CY
2024 PFS final rule (88 FR 79508)
including alignment with the
clarification provided regarding IA
automatic weighting for APM
participants (88 FR 79366).
In section IV.A.4.e.(3)(b)(IV) of this
proposed rule, we proposed to remove
weighting of improvement activities. We
conducted an analysis of this proposal
and determined that the impact on final
scores and payment adjustments was
negligible and therefore did not
incorporate it into our model.
(e) Methodology To Estimate the
Complex Patient Bonus Points
For the baseline and 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).
(f) Methodology To Estimate the Final
Score
We are not proposing any changes for
how we calculated the MIPS final score.
Our baseline and 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 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).
For the purposes of this model, if a
MIPS eligible clinician was approved
for reweighting of one or more
performance category to zero percent of
their final score, and the category’s
weight redistributed to other
performance category(ies), for the CY
2022 performance period/2024 MIPS
payment year (which was the data
source used in our model) in accordance
with our reweighting policies under
§ 414.1380(c)(2), then we continue to
apply that reweighting in our model by
assigning them a neutral score equal to
the performance threshold if all
categories were reweighted or assigning
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the applicable weights to the categories
which were reweighted. Although it is
unlikely (but possible) that the exact
same clinicians would apply for and
receive reweighting in both the CY 2022
performance period/2024 MIPS
payment year (which our data is based
on) and the CY 2025 performance
period/2027 MIPS payment year (which
we are simulating), we believe that this
assumption accurately reflects future
clinician behavior for two reasons. First,
while the exact same clinicians may not
receive reweighting 2 years in a row, we
believe that this assumption allows us
to quantify the impact of the
reweighting on a population level. In
other words, even if the same clinicians
do not apply for and receive reweighting
2 years in a row, the absolute number
of reweighting and the characteristic of
practices who receive reweighting is
likely to remain similar. Secondly, if we
were to not assign reweighting to those
clinicians, many of them would receive
a very low final score because they did
not submit data for one or more
performance categories during the year
in which they received reweighting. We
do not believe that it is realistic to
assume that, in the absence of
reweighting, those clinicians would
continue to not submit data. For these
reasons, clinicians who received
reweighting in the CY 2022 performance
period/2024 MIPS payment year also are
approved for reweighting in the CY
2025 performance period/2027 MIPS
payment year. These clinicians are
assigned a score of the performance
threshold (75) in our model because this
corresponds with a neutral (0 percent)
payment adjustment.
(g) 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 2024 PFS final rule
(88 FR 79373). In section IV.A.4.g.(2)(c)
of this proposed rule, we are proposing
to again set the performance threshold
at 75. Therefore, for both the baseline
and final policies models we used a
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performance threshold of 75 to calculate
the exchange function used for MIPS
payment adjustments. We note that the
results of this exchange are not identical
between the baseline and final policies
model. This is because the scaling factor
used to determine positive adjustments
is dependent on the total dollar amount
of negative payment adjustments and
those adjustments differ as final scores
are not identical between both models.
For both the baseline and 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) Simulation Results and Projected
Impact to MIPS Eligible Clinicians
Based on the methodology described
in the preceding sections we created a
baseline and proposed policies
simulation. Using this simulation, we
estimate the impact of the policies
proposed.
(a) Impact to Clinician Eligibility
In section VII.E.17.c.(2) of this
proposed rule, we noted that we are not
proposing any modification to clinician
eligibility and therefore there is no
difference in the total number of MIPS
eligible clinicians between our models.
(b) Impact to Clinician’s Final Scores
Table 137 shows the median final
score by practice size and the
percentage of MIPS eligible clinicians of
each practice size with a positive or
neutral or negative adjustment.
TABLE 137: CY 2025 Final Score Estimates by Practice Size
Practice
Size*
Total
Number
of MIPS
Eligible
Clinicians
Median
Final Score
Estimate**
Percent Eligible
Clinicians with
Positive Payment
Adjustment
Percent
Eligible
Clinicians
with Neutral
Payment
Adiustment
Percent Eligible
Clinicians with
Negative
Payment
Adjustment
Baseline
31.05%
22.00%
46.95%
60.47%
14.97%
24.56%
64.79%
10.32%
24.89%
74.84%
4.32%
20.84%
69.93%
7.23%
22.84%
Proposed Policies
1) Solo
18,867
32.41%
21.94%
45.65%
75.00
64.29%
14.78%
20.93%
2) 2-15
71 908
86.02
3) 16-99
72.41%
9.98%
17.61%
150.377
85.87
4) 100+
445,493
83.28%
4.13%
12.59%
87.19
77.51%
7.02%
15.47%
Overall
686,545
86.42
*Practice size is defmed as the number ofNPls in a TIN
** The median fmal score includes clinicians who receive reweighting for all MIPS performance categories our
policies at§ 414.1380(c)(2). These clinicians who have all performance categories reweighted are assigned a score
of75 (neutral payment adjustment) in our model.
18,867
71,908
150,377
445,493
686,645
75.00
81.79
81.76
82.80
82.20
lotter on DSK11XQN23PROD with PROPOSALS2
The median final score is 82.20 in our
baseline model and 86.42 in our
proposed policies model. There is an
increase in the number of clinicians
receiving a positive payment adjustment
for all practice sizes and an increase in
the median final score for all practice
sizes except for solo practitioners.828 We
project that 69.93 percent of MIPS
eligible clinicians will receive a positive
adjustment in our baseline model and
77.51 percent of MIPS eligible clinicians
will receive a positive adjustment in our
proposed policies model. This increase
is largely due to our proposed change to
the cost scoring methodology discussed
in section IV.A.4.f.(1)(d)(ii)(B) of this
proposed rule. Table 138 shows the
median cost score for MIPS eligible
clinicians who are scored on the cost
performance category for our baseline
and final policies model. There is a
substantial difference in median cost
scores between our two models. This is
true across all practice sizes. The
median cost category score is 59.16 in
our baseline model and 73.85 in our
proposed policies model.
828 See section VII.E.17.d.(b)(b)(i) of this proposed
rule for a discussion of the performance of solo
practitioners specifically.
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I) Solo
2) 2-15
3) 16-99
4) 100+
Overall
62193
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
TABLE 138: CY 2025 Cost Score Estimates by Practice Size
Practice Size
MIPS Eligible
Clinicians
Receiving Cost
Score
I) Solo
2)2-15
3) 16-99
4) 100+
Overall
7,380
32,476
65,428
226,035
331,319
1) Solo
2)2-15
3) 16-99
4) 100+
Overall
7,636
33 242
66,311
227.601
334,790
Figure 6 shows the distribution of
final scores for all MIPS eligible
clinicians. Note that there are a
relatively large number of MIPS eligible
clinicians with a final score of 75. As
stated in section VII.E.17.d.(3)(f) of this
proposed rule MIPS eligible clinicians
whom we approved for reweighting of
all MIPS performance categories in
Total Number
of MIPS
Eligible
Clinicians
Proportion of
MIPS Eligible
Clinicians
Receiving Cost
Score
Baseline
18,867
71,908
150,377
445,493
686,645
Proposed
Policies
18,867
71 908
150,377
445.493
686,545
Median Cost
Score Estimate
39.12%
45.16%
43.51%
50.74%
48.25%
62.15
59.89
60.30
59.02
59.16
40.47%
46.23%
44.10%
51.09%
48.76%
75.24
74.34
74.35
73.78
73.85
accordance with our reweighting
policies at § 414.1380(c)(2) are assigned
a final score of exactly the performance
threshold (75). Overall, the distribution
is skewed to the right indicating that
clinicians tend to receive final scores on
the higher end of the distribution with
many final scores clustered near the
performance threshold of 75. Our
proposed policies have the effect of
shifting final scores to the right. Many
clinicians with final scores just below
the performance threshold in the
baseline model see their scores
increased to a value just above the
performance threshold in the proposed
policies model.
FIGURE 6: Count of MIPS Eligibles Clinicians by Final Score
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lotter on DSK11XQN23PROD with PROPOSALS2
=Eligible Clinicians - Proposed
(i) Impact to Small and Solo Practices
18,867 MIPS eligible clinicians or 2.7
percent of all MIPS eligible clinicians
are solo practitioners in both the
baseline and final policies models. The
median final score for solo practitioners
VerDate Sep<11>2014
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62194
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
Section VII.E.17.d.(3)(f) of this
proposed rule, clinicians receiving
reweighting under our policies at
§ 414.1380(c)(2) are assigned a final
score exactly equal to the performance
threshold if we approved for
reweighting of all MIPS performance
categories.
These practitioners have a lower
median final score than other practice
sizes. This is largely due to the fact that
many of these solo practitioners do not
submit data to MIPS despite being MIPS
eligible clinicians. Our analysis
indicates that 49.45 percent of solo
practitioners submit data to MIPS
compared to 93.68 percent of all
clinicians. The median final score in our
baseline and proposed policies model is
75.00 for all solo practitioners, but for
solo practitioners who submit data the
median final score is 84.35 in the
baseline and 87.03 in the proposed
policies model. These findings indicate
that the lower final scores among solo
practitioners is likely due to not
reporting data to MIPS. Figure 7 shows
the distribution of final scores for solo
practitioners as a box plot. While the
median final score is 75 in both models,
the bottom quartile increases from 17.52
to 22.33 between the baseline and
proposed policies model. Figure 8
shows the final score distribution for all
practice sizes. The first quartile of final
scores is 75 in the baseline model and
77.45 in the proposed policies model.
The range between Q1 and Q3 is
significantly narrower for all practice
sizes than it is for solo practitioners.
Figure 9 shows the distribution of final
scores for solo practitioners who submit
data to MIPS. This distribution is much
closer to the distribution of final scores
in the overall population with the first
quartile at 73.45 in the baseline and
75.00 in the proposed policies model.
This is similar to the median final score
for all practice sizes which is 86.42.
This indicates that, while many solo
practitioners do not submit data to
MIPS, those who do submit data
perform similarly or better than the
overall population of MIPS eligible
clinicians. This is further evidence that
the main factor causing low final scores
among solo practitioners is the high
proportion who do not submit data.
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E:\FR\FM\31JYP2.SGM
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FIGURE 7: Distribution of Final Scores for Solo Practitioners
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
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FIGURE 8: Distribution of Final Scores for All Practice Sizes
62196
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
FIGURE 9: Distribution of Final Scores for Solo Practitioners who Submit Data
80
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Small practices, defined as groups
with a range between 2 and 15
clinicians, have a median final score of
81.79 in the baseline and 86.02 in the
proposed policies model. This is similar
but slightly lower than the median final
score for all practice sizes of 86.42.
Among small practices who submit data
the median final score is 89.81 in the
proposed policies model (and 86.83 in
the baseline). This is significantly
higher than the median final score for
all clinicians who submit data which is
87.53. This indicates that small
practices perform similarly to other
practice sizes although a slightly larger
proportion of small practices do not
submit data. Table 141 shows the
VerDate Sep<11>2014
20:32 Jul 30, 2024
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z
percentage of clinicians by practice size
who either do or do not submit data to
MIPS and the corresponding median
final score. Note that the median final
score for clinicians who do not submit
data is 75 for all practice sizes except for
solo practitioners. This indicates that
many clinicians belonging to small,
medium, or large practices (but not solo
practitioners) who do not submit data to
MIPS have been approved for
reweighting of all of their MIPS
performance categories under our
policies at § 414.1380(c)(2). In contrast,
many solo practitioners who do not
submit data do so despite not being
eligible for application of our
PO 00000
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reweighting policies or not applying for
reweighting under those policies.
A large majority of all practice sizes
except solo practitioners submit data to
MIPS. It is possible that the small
percentage of MIPS eligible clinicians in
those practice sizes who do not submit
data to MIPS are primarily MIPS eligible
clinicians who have received
reweighting under our policies at
§ 414.1380(c)(2). It should be noted that
median final scores increase for solo
and small practitioners between our
baseline and proposed policies model
indicating that the net effect of our
proposed policies is an increase in their
final scores.
E:\FR\FM\31JYP2.SGM
31JYP2
EP31JY24.188
lotter on DSK11XQN23PROD with PROPOSALS2
.:z
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62197
TABLE 139: Percentage of MIPS Eligible Clinicians who Submit Data and Median Final
Score
Percentage of
MIPS Eligible
Clinicians who
Submit Data (by
practice size)
Median Final Score of
MIPS Eligible
Clinicians who Do not
submit data.
Median Final Score of
MIPS Eligible Clinicians
who Submit Data
Baseline
1) Solo
2) Small (2-15)
3) Medium (16-99)
4) Large(lO0+)
Overall
49.39%
79.32%
91.69%
98.23%
93.47%
84.35
86.83
83.42
83.15
83.46
19.35
75
75
75
75
I) Solo
49.45%
79.46%
92.03%
98.41%
93.68%
Proposed Policies
87.03
89.81
87.27
87.31
87.53
22.89
75
75
75
75
2) Small (2-15)
3) Medium (16-99)
4) Large(l 00+)
Overall
(ii) Impact to Rural Providers
In our data we assign rural
practitioners a special status. Analysis
of this group of clinicians indicates that
their final scores are similar to the
overall population of MIPS Eligible
Clinicians across all practice sizes.
Table 140 shows the median final score
and the percentage of eligible clinicians
with a positive or neutral or negative
adjustment by practice size.
Total
Number
of MIPS
Eligible
Clinicians
Median
Final Score
Estimate
1) Solo
2) 2-15
3) 16-99
4) 100+
Overall
2,694
11,760
30,444
43,286
88,184
75.00
83.89
85.05
80.43
81.29
1) Solo
2) 2-15
3) 16-99
4) 100+
Overall
2,694
11,762
30,409
43,281
88,146
75.00
87.34
87.53
84.27
85.41
The median final score for all rural
practitioners is 81.29 in our baseline
model and 85.41 in our proposed
policies model. This is slightly lower
than the median final score for all
practitioners which is 82.20 in our
baseline model and 86.42 in our
proposed policies model. However, the
median final score is identical for solo
practitioners and higher for small and
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Percent Eligible
Clinicians with
Positive Payment
Adjustment
Baseline
34.89%
65.94%
71.38%
69.02%
68.38%
Proposed Policies
36.53%
69.82%
76.90%
81.78%
77.12%
Percent
Eligible
Clinicians
with Neutral
Payment
Adjustment
Percent Eligible
Clinicians with
Negative
Payment
Adjustment
17.37%
10.48%
6.80%
5.08%
6.77%
47.74%
23.58%
21.82%
25.90%
24.85%
17.33%
10.42%
6.37%
4.94%
6.54%
46.14%
19.76%
16.73%
13.28%
16.34%
medium practices. Large rural providers
have a slightly lower median final score
compared to large practices generally.
The lower overall median final scores
for rural practitioners are driven by
large rural practices who perform
slightly worse than other practice sizes
and when compared to large practices
generally. It should be noted that
median final scores increase for rural
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providers of all practice sizes between
our baseline and proposed policies
model indicating that the net effect of
our proposed policies is an increase in
their final scores.
E:\FR\FM\31JYP2.SGM
EP31JY24.190
Practice
Size
31JYP2
EP31JY24.189
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TABLE 140: CY 2025 Final Score Estimates by Practice Size for Rural Practitioners Only
62198
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
(iii) Impact to Safety Net Providers
(a) Updated Definition of Safety Net
Providers
In the CY 2023 PFS final rule (87 FR
70094), we finalized our complex
patient bonus methodology. This bonus
is composed of two distinct calculations
which are added together: Medical
Complexity and Social Risk. Medical
Complexity is determined based on a
MIPS eligible clinicians Hierarchical
Conditions Categories risk score and
social risk is determined based on the
proportion of a MIPS eligible clinicians
Medicare patient population who are
dually eligible for both Medicare and
Medicaid.
In the CY 2024 PFS final rule (88 FR
79513), we compared the performance
of clinicians who received the complex
patient bonus with our overall
population. As we further developed
our model, we decided to adopt a more
precise definition of safety net
providers. We believe that by narrowing
our definition of safety net providers to
the top 20 percent (80th percentile) of
social risk we can identify the providers
who are caring for the largest proportion
of low-income or otherwise socially
vulnerable individuals.
Table 143 shows the final score
estimates for safety net providers under
this new definition. Safety net provers
have higher median final scores than the
overall population of MIPS eligible
clinicians across all practice sizes with
the exception of small and solo
practitioners. When our analysis is
restricted to providers who submit data
to MIPS this discrepancy disappears
and small and solo safety net providers
who submit data have higher median
final scores than the overall population
of small and solo MIPS eligible
clinicians who submit data. However,
only 43.65 percent of solo and 72.90
percent of small safety net providers
submit data compared to 49.45 percent
and 79.46 percent of the overall
population of solo and small MIPS
eligible clinicians respectively. These
results are shown in Table 141. This
indicates that the lower scores among
small and solo safety net practitioners is
likely due to a larger number of these
practitioners not submitting data. It
should be noted that median final scores
increase for solo and small safety net
providers between our baseline and
proposed policies model indicating that
the net effect of our proposed policies
is an increase in their final scores.
VerDate Sep<11>2014
Practice
Size
Total
Number
of MIPS
Eligible
Clinicians
Median
Final Score
Estimate
1) Solo
2) 2-15
3) 16-99
4) 100+
Overall
5,347
14,202
37,246
82,916
139,711
62.31
80.84
85.12
86.18
85.35
1) Solo
2) 2-15
3) 16-99
4) 100+
Overall
5,347
14,208
37,212
82,839
139,606
65.78
84.50
88.31
89.23
88.59
20:32 Jul 30, 2024
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Percent Eligible
Clinicians with
Positive Payment
Adjustment
Baseline
26.95%
55.01%
66.77%
83.59%
74.04%
Proposed Policies
27.70%
57.18%
70.48%
87.11%
77.36%
Frm 00604
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Sfmt 4725
Percent
Eligible
Clinicians
with Neutral
Payment
Adiustment
Percent Eligible
Clinicians with
Negative
Payment
Adjustment
20.07%
15.56%
12.97%
5.64%
9.15%
52.98%
29.43%
20.26%
10.77%
16.81%
20.05%
15.52%
12.79%
5.53%
9.03%
52.25%
27.30%
16.73%
7.36%
13.61%
E:\FR\FM\31JYP2.SGM
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EP31JY24.191
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TABLE 141: CY 2025 Final Score Estimates by Practice Size
for Safety Net Practitioners Only
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62199
TABLE 142: CY 2025 Median Final Scores for Safety Net Practitioners who Submit Data
Percent of
MIPS
Eligible
Clinicians
who
Submit
Data
Median Final
Score
Estimate
1) Solo
2) 2-15
3) 16-99
4) 100+
Overall
43.63%
72.90%
91.73%
98.47%
91.97%
86.12
89.51
86.54
86.18
86.37
1) Solo
2) 2-15
3) 16-99
4) 100+
Overall
43.65%
72.94%
91.90%
98.58%
92.08%
89.06
92.29
89.53
89.31
89.57
Baseline
61.77%
75.46%
72.78%
84.88%
80.48%
Proposed Policies
63.45%
78.39%
76.67%
88.35%
83.99%
Percent
Eligible
Clinicians with
Neutral
Payment
Adjustment
Percent Eligible
Clinicians with
Negative Payment
Adjustment
10.84%
7.06%
8.45%
4.45%
5.85%
27.39%
17.48%
18.77%
10.67%
13.67%
10.84%
7.04%
8.44%
4.45%
5.83%
25.71%
14.57%
14.89%
7.20%
10.18%
We are not proposing an increase in
the performance threshold in this
proposed rule. However, payment
adjustments differ between the baseline
and final policies model. This is
because our proposed policies increase
final scores of MIPS eligible
clinicians 829 and therefore a larger
proportion of MIPS eligible clinicians
receive a final score greater than the
performance threshold and thus a
positive payment adjustment. The
parameters of the exchange function
used to determine payment adjustments
depends on the final score distribution
of MIPS eligible clinicians. As the
proportion of MIPS eligible clinicians
829 This increase is largely due to the change in
our cost performance category scoring policies
discussed in section IV.A.4.f.(1)(d)(ii)(B) of this
proposed rule.
(c) Impact to MIPS Eligible Clinicians’
Payment Adjustments
lotter on DSK11XQN23PROD with PROPOSALS2
Percent Eligible
Clinicians with
Positive Payment
Adjustment
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receiving a negative payment
adjustment decreases the budget neutral
funds available for redistribution also
decrease. In the baseline model we
project redistributing $517 million and
in the proposed policies model we
project redistributing $458 million. This
decrease means that the scaling factor
for positive adjustments is reduced.
E:\FR\FM\31JYP2.SGM
31JYP2
EP31JY24.192
Practice
Size
62200
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
FIGURE 10: Payment Adjustment Function
4.00%
2.00%
o.ooria..,
-2.00%
-4.00%
-6.00%
,\
-8.00%
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-
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Payment Adjustment(%) - Baseline
We also report the median positive
and negative payment adjustments by
practice size in Table 143.
TABLE 143: CY 2025 Median Positive and Negative Payment Adjustment
Estimates By Practice Size
Practice Size
Median Positive Payment Adjustment*
Solo (1)
Small (2-15)
Medium (16-99)
Large (>99)
Overall
2.06%
1.82%
1.65%
1.59%
1.65%
Median Negative Payment
Ad_justment*
Baseline
-9.00%
-4.69%
-1.25%
-0.88%
-1.10%
For all practices sizes except for solo
practitioners the median negative
VerDate Sep<11>2014
20:32 Jul 30, 2024
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payment adjustment increases in
magnitude. This is because many MIPS
PO 00000
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Sfmt 4702
eligible clinician’s final scores are
clustered near the performance
E:\FR\FM\31JYP2.SGM
31JYP2
EP31JY24.194
Solo (1)
1.55%
-6.42%
Small (2-15)
1.46%
-5.88%
Medium (16-99)
1.35%
-1.44%
Large (>99)
1.28%
-1.08%
Overall
1.31%
-1.48%
*The median positive payment adjustment is defined as the medium payment adjustment among clinicians with a
final score above the performance threshold. The median negative adjustment is defined as the medium payment
adjustment among clinicians with a final score below the performance threshold. Neither median includes clinicians
with a final score equal the performance threshold.
EP31JY24.193
lotter on DSK11XQN23PROD with PROPOSALS2
Proposed Policies Model
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
threshold. An increase in median final
scores will cause many of those
clinicians who have a minor negative
adjustment to meet or exceed the
performance threshold and therefore be
removed from the population of
clinicians with a negative adjustment.
The remaining population of MIPS
eligible clinicians with negative
adjustments are more likely to have
negative payment adjustments higher in
magnitude. In contrast to other practice
sizes. fewer solo practitioners with
negative payment adjustments have a
final score near the performance
threshold and an increase in the final
score of these MIPS eligible clinicians
will reduce the size of their negative
payment adjustment but is less likely to
shift their final scores above the
performance threshold in the manner
described earlier. As discussed in
section VII.E.17.d.(4)(b)(i) of this
proposed rule, this is largely because
62201
many of these solo practitioners do not
submit data to MIPS despite being MIPS
eligible clinicians. Our analysis
indicates that 49.45 percent of solo
practitioners submit data to MIPS in our
proposed policies model compared to
93.70 percent of all MIPS eligible
clinicians. In Table 144, we report the
proportion of MIPS eligible clinicians
who either did or did not submit data
with the maximum negative adjustment
(¥9 percent).
TABLE 144: CY 2024 CY 2024 Clinicians With The Maximum Negative Adjustment
Percent of Clinicians who Did NOT
Submit Data with Maximum
Negative Adjustment
Baseline (-9%)
Practice Size
48.94%
35.75%
17.88%
11.71 %
29.35%
Solo (1)
Small (2-15)
Medium (16-99)
Large (>99)
Overa11
Percent of Clinicians Who
Submit Data With Maximum
Negative Adjustment
2.90%
0.84%
0.37%
0.12%
0.28%
Proposed Policies Model (-9%)
35.57%
25.23%
12.52%
5.50%
20.77%
lotter on DSK11XQN23PROD with PROPOSALS2
Across all practice sizes the
proportion of clinicians who do not
submit data who receive the max
negative payment adjustment decreased
between the baseline and proposed
policies model. A larger proportion of
solo practitioners (2.26 percent) who
submit data receive the maximum
negative adjustment.
The median positive adjustment for
solo practitioners is 1.55 percent which
is higher than the median positive
adjustment for all practice sizes overall.
This indicates that, while many solo
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2.26%
0.72%
0.35%
0.10%
0.24%
practitioners do not submit data to
MIPS, those solo practitioners who do
report data to MIPS and receive a
positive adjustment receive a similar
median adjustment to other practice
sizes.
e. Additional Impacts From Outside
Payment Adjustments
(1) Burden Overall
In addition to policies affecting
payment adjustments, we are proposing
several policies that have an impact on
burden in the CY 2025 performance
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period/2027 MIPS payment year. In
section V.B.8. of this proposed rule, we
outline estimates of the costs of data
collection that include both the effect of
proposed policy updates and
adjustments due to the use of updated
data sources. For each proposed
provision included in this proposed rule
that impacts our estimate of collection
burden, we summarize the incremental
burden in Table 145. We also provide
proposed additional burden discussions
that we are not able to quantify.
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Solo (1)
Sma11 (2-15)
Medium (16-99)
Large (>99)
Overa11
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TABLE 145: Incremental Estimated Burden from Associated Proposed Policies
(A stens
• k s re fier to paragrap h d'trect I1" fio II owmg ta bl:)
e
Burden Description and Associated Proposed Provisions
Burden Hours
Total burden associated with the provision to continue the
policies and ICRs set forth in the CY 2024 PFS final rule into the
CY 2025 performance period/2027 MIPS payment year with
657,110
updated data and assumptions (as outlined in section V.B.8. of
this proposed rule).
Burden change for MVP registration ICR due to the provision of
additional MVPs (as outlined in section V.B.8.e.(7)(a)(i). of this
+626
proposed rule). *
Burden change for Quality Data Submission by Clinicians:
Medicare Part B Claims-Based Collection Type ICR for
-7,697
capturing reduced number of quality submissions due to the
provision of additional MVPs (as outlined in section V.B.8.e.( 4).
of this proposed rule). *
Burden change for Quality Data Submission by Clinicians:
CQM/QCDR Collection Type ICR for capturing reduced number
-6,866
of quality submissions due to the provision of additional MVPs
(as outlined in section V.B.8.e.(5). of this proposed rule). *
Burden change for Quality Data Submission by Clinicians:
eCQM Collection Type ICR for capturing reduced number of
-9,664
quality submissions due to the provision of additional MVPs (as
outlined in section V.B.8.e.(6). of this proposed rule). *
Burden change for MVP Quality Submission ICR submissions
+16,031
due to the provision of additional MVPs (as outlined in section
V.B.8.e.(7)(a)(iii). of this proposed rule). *
Total change in burden due to policy for CY 2025
-7,570
Total burden set forth in the CY 2025 PFS proposed rule
649,540
Burden Dollars
$77,779,594
+$66,759
-$898,035
-$823,269
-$1,176,109
+$1,917,478
-$913,176
$76,866,418
* The total change in burden due to this proposed provision includes an increase in burden due to an anticipated increase in the
number of respondents that will participate in MVP reporting based on the proposed addition of 6 new MVPs. Therefore, there
will be a decrease in burden in the "Quality Data Submission: MIPS CQM and QCDR collection type," "Quality Data
Submission: eCQM collection type," and "Quality Data Submission: Claims collection type" ICRs due to respondents who
previously submitted MIPS through those collection types submitting data with reduced Quality submission requirements as a
MVP participant. Total change in burden also includes the increase in submission burden due to the increase in the number of
respondents for "MVP registration." See section V.B.8.e.(2).ofthis proposed rule.
lotter on DSK11XQN23PROD with PROPOSALS2
(a) Impact on Third Party Intermediaries
In section IV.A.4.j.(1)(b). of this
rulemaking, we are proposing that as
part of the Consumer Assessment of
Healthcare Providers & Systems
(CAHPS) vendor registration process, in
addition to the previously established
registration requirements, CAHPS
vendors would provide information on
the range of costs for their services
beginning with the CY 2026
performance period/2028 MIPS
payment year. We recognize that there
may be additional minimal burden
associated with the proposed cost
information requirement for the CAHPS
vendor registration. However, we
assume that this information is brief and
readily available to vendors completing
the registration process. We are unable
to quantify the additional impact for the
proposed CAHPS vendor cost
requirement.
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(b) Modifications to the Improvement
Activities Inventory
As discussed in section
IV.A.4.e.(3)(b)(iii). of this proposed rule,
we are proposing changes to the
improvement activities inventory for the
CY 2025 performance period/2027 MIPS
payment year and future years as
follows: adding two new improvement
activities; modifying two existing
improvement activity; and removing
eight previously adopted improvement
activities. We refer readers to Appendix
2 of this proposed rule for further
details. We do not expect these changes
to the improvement activities inventory
to affect our currently approved
information collection burden for the
number of estimated respondents. Most
of the improvement activities in the
Inventory remain unchanged for the CY
2025 performance period/2027 MIPS
payment year. We refer readers to
section IV.A.4.e.(3)(b)(iii). of this
proposed rule for additional information
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on changes to the improvement
activities Inventory.
(c) Modifications to Improvement
Activities Scoring and Reporting
Policies
As discussed in section
IV.A.4.e.(3)(b)(iv)., we are proposing
two scoring and reporting policy
changes for the improvement activities
performance category effective for the
CY 2025 performance period/2027 MIPS
payment year and subsequent years. As
noted in section V.B.8.h., we established
our currently approved estimate that it
will take a computer analyst 5 minutes
to log in and manually attest that
improvement activities were completed
in the CY 2019 PFS final rule (83 FR
60016). In the CY 2024 PFS final rule
(88 FR 79454 and 79455), this estimate
included scenarios where participants
might submit 1, 2, 3, or 4 activities for
the improvement activities category,
based on medium- or high-weighted
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lotter on DSK11XQN23PROD with PROPOSALS2
activities and any additional weighting
scenarios such as for MIPs Value
Pathways (MVP) Participants. We
believe this proposal would decrease
burden for MIPS participants who
previously reported medium-weighted
activities. As MIPS participants who
previously only reported high weighted
activities would have the same
attestation requirements under this
proposal, we propose to continue our
currently approve estimates of 5
minutes to log in and attest that
improvement activities are completed.
We expect reduced reporting burden for
clinicians who previously reported at
least one medium-weighted activity;
however, we are unable to estimate the
aggregated impact of this proposal given
the current weighting and scoring rules
that affect the number of activities each
clinician submits to receive full credit
for the improvement activities
performance category.
(d) MVP Maintenance Process
In section VII.E.17.e.(2)(d). of this
proposed rule, we are proposing a
modification to the MVP maintenance
webinar process previously finalized in
the CY 2022 PFS final rule (86 FR
65410) and modified in the CY 2023
PFS final rule (87 FR 70037). We
communicated that if we identified any
potentially feasible and appropriate
submitted maintenance
recommendations, we would host a
public facing webinar open to interested
parties and the general public through
which they could offer their feedback on
the potential maintenance updates we
have identified.
Due to the low volume of submitted
maintenance recommendations in past
years, we are proposing to provide us
more flexibility in how we
communicate maintenance
recommendations prior to proposing
them in rulemaking. Allowing flexibility
in communicating recommendations
through alternative webinar formats or
other public communication channels
would offer similar opportunities for
public review and feedback as a live
public webinar. For example, in lieu of
a live webinar, we could choose to
communicate submitted maintenance
recommendations via a pre-recorded
webinar, which will encourage
interested parties to submit their
feedback on the submitted
recommendations in writing by email
before maintenance updates are
formally proposed in rulemaking.
As with the CY 2023 PFS final rule
(87 FR 70210 through 70211), we
acknowledge that there is administrative
burden associated with the monitoring
and review of the candidate MVPs. We
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are uncertain on the number of
interested parties and members of the
general public that will submit their
recommendations for potential revisions
to established MVPs for an applicable
performance period. We are also
uncertain if CMS will host a public
webinar, webinar alternative, or other
communications based on the review of
the recommendations. In summary, we
are unable to quantify the impact
associated with the proposed changes to
the MVP development and maintenance
process.
(e) Reweighting Performance Categories
When Data Is Not Submitted Due to
Reasons Outside the Clinician’s Control
In section IV.A.4.i.(2) of this
rulemaking, we are proposing to adopt
a new reweighting policy at 42 CFR
414.1380(c)(2)(i)(A)(10) and
(c)(2)(i)(C)(12). Specifically, we are
proposing that, beginning with the CY
2024 performance period/2026 MIPS
payment year, we may reweight one or
more of the performance categories
(specifically, quality, improvement
activities, or Promoting
Interoperability), where we determine,
based on information submitted to us on
or before November 1st of the year
preceding the relevant MIPS payment
year, that data for a MIPS eligible
clinician are inaccessible or unable to be
submitted due to circumstances outside
of the control of the clinician because
the MIPS eligible clinician delegated
submission of the data to their third
party intermediary, evidenced by a
written agreement between the MIPS
eligible clinician and third party
intermediary, and the third party
intermediary did not submit the data for
the performance category(ies) on behalf
of the MIPS eligible clinician in
accordance with applicable deadlines.
We also are proposing that, to determine
whether to apply reweighting to the
affected performance category(ies), we
will consider: whether the MIPS eligible
clinician knew or had reason to know of
the issue with its third party
intermediary’s submission of the
clinician’s data for the performance
category(ies); whether the MIPS eligible
clinician took reasonable efforts to
correct the issue; and whether the issue
between the MIPS eligible clinician and
their third party intermediary caused no
data to be submitted for the performance
category(ies) in accordance with
applicable deadlines. More details on
this proposed reweighting policy are
provided in section V.B.8.g.(2) of this
proposed rule.
Because this is a new policy and we
believe these occurrences would be rare
based on our experience, we are unable
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62203
to estimate the number of clinicians,
groups, or third party intermediaries
that may apply for reweighting based on
this policy. Similarly, the extent and
source of documentation provided to us
for each event may vary considerably.
Therefore, we are not proposing any
changes to our currently approved
burden estimates as a result of this
proposal.
(f) Advanced Primary Care Management
As discussed in section II.G.2. of this
proposed rule, we are proposing to
adopt specific coding and payment
policies for advanced primary care
management (APCM) services for use by
practitioners who are providing services
under this specific model of ‘‘advanced
primary care,’’ beginning January 1,
2025. These services would be
furnished under the direction of a
physician or other qualified health care
professional who is responsible for all
primary care (e.g., physicians and nonphysician practitioner, including nurse
practitioner, physician assistant,
certified nurse midwife and clinical
nurse specialist), and serve as the
continuing focal point for all needed
health care services, during a calendar
month. We are proposing three new
APCM codes that would recognize the
resources involved in furnishing
ongoing, beneficiary-centered care
management services under the broad
model of advanced primary care
without paying for each activity
separately while allowing for flexibility
in addressing patient needs. APCM
payment would incorporate several
specific, existing care management and
communication technology-based
services into a bundle and require
reporting the Value in Primary Care
MVP beginning in the CY 2025
performance period/2027 MIPS
payment year. Billing practitioners who
are not MIPS eligible clinicians (as
defined at 42 CFR 414.1305) would not
be required to report the MVP in order
to furnish and bill for APCM services.
As discussed in section V.B.8.e.(7)(a) of
this proposed rule, we are unable to
estimate the effect of this proposal on
MVP submissions and registrations for
the CY 2025 performance period/2027
MIPS payment year as the codes are
newly proposed. Specifically, we are
unable to determine how many
additional clinicians or practices would
submit the Value in Primary Care MVP
measures for the CY 2025 performance
period/2027 MIPS payment year above
our current estimates. Similarly, we
cannot assess what participation levels
clinicians or practices who might use
these APCM codes, if finalized, have
reported MIPS in the past (for example,
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eligibility requirements and special
statuses, participation at the individual,
group, virtual group, or Alternative
Payment Model (APM) Entity level, or
reporting via traditional MIPS, the APM
Performance Pathway (APP), or MVPs),
or if they will be MIPS eligible
clinicians in future years. For MIPS
eligible clinicians who move from
reporting traditional MIPS to MVPs, we
expect a decrease in overall program
burden due to the reduced number of
measures required for reporting the
quality performance category. We will
update these assumptions for MVP
quality performance category reporting
and MVP registration as more
information is available.
lotter on DSK11XQN23PROD with PROPOSALS2
(g) Mandatory Subgroup Registration
As summarized in section
IV.A.3.c.(1). we established a voluntary
subgroup participation option for
clinicians choosing to report an MVP
beginning in the CY 2023 performance
period/2025 MIPS payment year. We
finalized a mandatory subgroup
reporting requirement for multispecialty
groups choosing to report as an MVP
Participant beginning in the CY 2026
performance period/2028 MIPS
payment year (§ 414.1305; 86 FR 65394
through 65397). Beginning with the CY
2026 performance period/2028 MIPS
payment year, a single specialty group
may continue to submit data for an MVP
at the group level, and a multispecialty
group must form subgroups to report an
MVP. Under the existing subgroup
reporting policies, a group could place
clinicians providing similar scope of
care into one or more subgroups for
reporting a relevant MVP. Each clinician
may participate in one subgroup per tax
identification number (TIN). The
remaining clinicians under the group
TIN not part of a subgroup could
participate as individuals to report an
MVP or traditional MIPS. The entire
group TIN (including the clinicians that
are part of the subgroup) could also
submit data as a group in traditional
MIPS. We note section IV.A.3.d.
includes a Request for Information (RFI)
to obtain feedback on what guidance/
parameters are needed for
multispecialty groups to place clinicians
into subgroups for reporting an MVP
relevant to the scope of care provided.
Absent available submission data on
MVP and subgroup reporting as
discussed in section V.B.8.e.(7)(a)(ii),
we are unable to estimate the effect of
this established policy on reporting for
the CY 2026 performance period/2028
MIPS payment year.
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(h) APM Performance Pathway Plus
Quality Measure Set
In section IV.A.4.c.(2). of this
proposed rule, we are proposing to
establish the APP Plus quality measure
set beginning in the CY 2025
performance period/2027 MIPS
payment year. As described in section
V.B.8.a.(4)., clinicians reporting the
proposed APP Plus quality measure set
would report via one of the available
collection types per measure: eight
measures for the CY 2025 performance
period/2027 MIPS payment year; nine
measures for the CY 2026 and 2027
performance periods/2028 and 2029
MIPS payment years; and eleven
measures for the CY 2028 performance
period/2030 MIPS payment period. For
the available collection types per
measure, please see Tables 55, 56, and
57 in section IV.A.4.c.(3)(f).
In section V.B.8.a.(4). of this proposed
rule, we compare the quality
performance category burden for MIPS
eligible clinicians who elect to report
the proposed APP Plus quality measure
set compared to the current APP quality
measure set, traditional MIPS, and
MVPs. We focus these analyses on
quality measures required for MIPS
eligible clinicians under the eCQM,
CQM/QCDR, and Medicare Part B
claims collection types. We note, these
assumptions for actively submitting to
assess clinician burden may differ from
MIPS scoring policy. In that
comparison, we assume MIPS eligible
clinicians incur no burden for reporting
the two administrative claims quality
measures currently required under the
APP quality measure set. Additionally,
burden estimates for the CAHPS for
MIPS registration and patient reporting
are provided in the CAHPS for MIPS
PRA package under OMB control
number 0938–1222 (CMS–10450); we do
not assume that MIPS eligible clinicians
incur additional reporting burden for
reporting the CAHPS for MIPS quality
measure under the current APP quality
measure set. Therefore, MIPS eligible,
clinicians reporting the proposed APP
Plus quality measure set beginning in
the CY 2025 performance period/2027
MIPS payment year would need to
actively submit performance data for
more quality measures than clinicians
reporting via MVPs or the APP.
Compared to clinicians reporting via
traditional MIPS, clinicians reporting
the proposed APP Plus quality measure
set would actively submit performance
data for fewer quality measures for the
CY 2025 performance period/2027 MIPS
payment year; the same number of
quality measures for the CY 2026 and
2027 performance periods/2028 and
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2029 MIPS payment years, and more
measures for the CY 2028 performance
period/2030 MIPS payment year.
As noted in the CY 2021 PFS final
rule, one goal of the APP quality
measure set was to reduce the reduce
the burden of reporting quality
measures twice; once to MIPS and once
to their APMs; therefore, clinicians
reporting the APP and APP Plus who
are require by their APMs to submit the
same measure sets incur limited
additional burden (88 FR 84862). We
assume that all Shared Savings Program
ACOs will report the APP via the APP
Plus measure set for the CY 2025
performance period/2027 MIPS
payment year. Per section 1899(e) 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. As the APP Plus is a new and
optional quality measure set for nonShared Savings Program ACOs with
greater reporting burden than the
current APP quality measure set and
APM specific requirements may vary,
we are unable to estimate how many
individual MIPS eligible clinicians,
groups, or APM Entities would submit
quality measures via the APP Plus at
this time. Our burden estimates
currently assume MIPS eligible
clinicians in non-Shared Savings ACO
APM Entities will participate through
traditional MIPS or MVPs, submitting as
an individual or group rather than as an
APM Entity. We will update these
estimates and assumptions as additional
data are available.
i. Assumptions & Limitations
In our MIPS eligible clinician
assumptions, we assumed that
clinicians who elected to opt-in for the
CY 2022 Quality Payment Program and
submitted data will continue to elect to
opt-in for the CY 2025 performance
period/2027 MIPS payment year.
As discussed in section V.B.8. of this
proposed rule, we are unable to predict
which specific MIPS eligible clinicians
would receive reweighting for one or
more performance categories under
policies at § 414.1380(c)(2) in the CY
2025 performance period/2027 MIPS
payment rear. On this basis, we assume
that those MIPS eligible clinicians for
whom we approved reweighting of one
or more performance categories under
our policies are representative of the
number and attributes of MIPS eligible
clinicians who will receive reweighting
under these policies in the future.
In addition to the limitations
described throughout the methodology
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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 137.
F. Alternatives Considered
This proposed rule contains a range of
policies, including some proposals
related to specific statutory provisions.
The preceding preamble provides
descriptions of the statutory provisions
that are addressed, identifies those
policies when we 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.
lotter on DSK11XQN23PROD with PROPOSALS2
1. Alternatives Considered Related to
Strategies for Improving Global Surgery
Payment Accuracy
As discussed previously and in
section II.G. of this proposed rule,
beginning for services furnished in
2025, we are proposing to broaden the
applicability of the transfer of care
modifiers for the 90-day global
packages. We are proposing to require
the use of the appropriate transfer of
care modifier (modifier –54, –55, or –56)
for all 90-day global surgical packages in
any case when a practitioner (or another
within the same group practice) expects
to furnish only a portion of a global
package (including but not limited to
when there is a formal, documented
transfer of care as under current policy
or an informal, non-documented but
expected, transfer of care). Practitioners
billing for a global package procedure
code with modifier –54 and other
practitioners in the same group practice
as that practitioner would still be able
to bill during the global period for any
separately identifiable E/M services they
furnish to the patient that are unrelated
to the global package procedure.
Additionally, we are proposing a global
surgical add-on code, HCPCS code
GPOC1, which we expect will be billed
during the postoperative period of 90
days following the procedure. We
expect that this code will be billed once
during that timeframe when the patient
is seen for an office/outpatient (O/O)
evaluation and management (E/M) visit
that is related to the recent surgical
procedure. We believe that this code
will be billed by a physician or
practitioner who is seeing the patient for
a visit during the post-operative period
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and did not furnish the surgical
procedure.
As we were developing this proposal,
we analyzed a few different policy
options to best achieve our goal of
improving the payment accuracy of the
global packages. We considered whether
to propose to revalue the 10 and 90-day
global packages on the PFS utilizing our
findings and data under the MACRA
requirement to improve payment
accuracy on the fee schedule, however
we are precluded from doing so under
MACRA. We also considered revaluing
services specifically included in the
RAND study,830 which looked at claims
for which reporting of follow up visits
was requested. We also considered
proposing requiring separate billing,
which would result in separate
payments for the procedures and post
operative visits in global packages,
based on our current research and
analysis of how practitioners may be
furnishing care described by global
packages. We considered this alternative
policy as an initial step towards more
accurately paying for global packages,
specifically for services including high
utilization global packages discussed in
the RAND study. We also considered
proposing revisions to all global surgical
packages in a phased approach starting
with the subset of packages described
above and gradually revising other
global packages over time, to manage
payment predictability and stability
within the PFS, rec.
2. Alternatives Considered Related to
the Supervision of Outpatient Therapy
Services in Private Practices
As discussed in section II.H of this
proposed rule, we are proposing to
allow for the general supervision of
occupational therapy assistants (OTAs)
and physical therapist assistants (PTAs),
by OT’s and PT’s in private practice
(OTPPs and PTPPs, respectively) who
are enrolled as suppliers in Medicare.
Currently, and since 2005, OTPPs and
PTPPs are required to provide direct
supervision of their OTAs and PTAs
which requires the OTPP/PTPP to be
immediately available to furnish
assistance and direction throughout the
performance of the procedure in the
office suite or in the patient’s home
when Medicare patients are treated in
order to bill for therapy services
furnished by their supervised OTAs and
PTAs.
In developing our proposal to allow
for general supervision in these private
830 Using Claims-Based Estimates of PostOperative Visits to Revalue Procedures with 10- and
90-Day Global Periods; Updated Results Using
Calendar Year 2019 Data.
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62205
practice settings, we considered the
possibility of allowing for virtual direct
supervision by the OTPP/PTPP instead,
as we have included OTPPs/PTPPs as
‘‘supervising practitioners’’ in the
application of our virtual direct
supervision policy since October 6,
2021, which is now extended through
CY 2024. Due to the private practice
direct supervision regulatory
requirement, when using virtual direct
supervision, this means (per our
clarification in the CY 2021 PFS final
rule (85 FR 84539)) that the OTPP or
PTPP could meet the virtual direct
supervision requirement by being
immediately available to engage via
audio/video technology (excluding
audio-only), and would not require realtime presence or observation of the
service via interactive audio and video
technology throughout the performance
of the service.
However, if this alternative policy
were selected, it would leave the direct
supervision requirement in place for
OTPPs and PTPPs and they’d still have
to be immediately available to engage
via audio/video technology and ensure
their availability to do so. On the other
hand, with general supervision, the
OTPP’s/PTPP’s physical or virtual
presence is not required when the OTA/
PTA furnishes services, although the
services continue to be furnished under
their overall direction and control
allowing the OTPP/PTPP, for example,
to provide an evaluative service in the
office while the OTA/PTA is off-site
furnishing therapy services in a
patient’s home.
3. 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. In section
IV.A.4.g.(2)(c) of this proposed rule, we
proposed to set the performance
threshold to 75 points for the CY 2025
MIPS performance period/CY 2027
MIPS payment year. Eighty-six (86) is a
possible alternative value (mean of the
CY 2019 performance period/2021 MIPS
payment year) which we did not
propose. To assess this alternative
value, we ran a separate RIA model with
a performance threshold of 86. This
model has the same mean and median
final score as our proposed policies RIA
model since the alternative performance
threshold which we are assessing in this
model does not change the final score.
In our analysis of the alternative
performance threshold of 86, which we
considered but did not propose, 55.98
percent of MIPS eligible clinicians who
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submitted data would receive a negative
payment adjustment in the baseline and
45.08 percent of MIPS eligible clinicians
who submit data would receive a
negative adjustment in the proposed
policies model.
We also reported the findings for the
baseline RIA model which describes the
impact for the CY 2025 performance
period/2027 MIPS payment year if this
proposal is not finalized. The baseline
RIA model has a median final score of
82.20. We estimated that $517 million
would be redistributed based on the
budget neutrality requirement in the
baseline model. The baseline includes a
maximum payment adjustment of 2.98
percent and 22.84 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 proposed HEBA would mainly
provide upwards adjustments to
benchmarks for—and likely draw
increased participation from—new
ACOs with particular focus on
coordinating care for beneficiaries in
underserved communities. New ACOs
of this type are therefore projected to
ultimately increase assignment to the
Shared Savings Program by roughly
500,000 beneficiaries per year, ranging
from 50,000 to 1.0 million at the low
and high ends of this projection range.
ACOs have been found to perform
better on certain patient-experience and
performance measures than physician
groups participating in the MIPS. In
performance year 2022, ACOs had a
higher average performance on quality
measures they are required to report in
order to share in savings compared to
other similarly sized clinician groups
not in the Shared Savings Program.831
This includes statistically significant
higher performance for quality measures
related to diabetes and blood pressure
control; breast cancer and colorectal
cancer screening; tobacco screening and
smoking cessation; and depression
screening and follow-up.832 We
anticipate that ACOs will continue to
improve the quality of care for their
Medicare fee-for-service beneficiaries
through the reporting of Medicare
CQMs, and that ACOs will continue to
831 CMS, Press Release, ‘‘Medicare Shared
Savings Program Saves Medicare More Than $1.8
Billion in 2022 and Continues to Deliver High-
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improve the quality of care for their all
payer/all patient population through the
reporting of eCQMs.
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 policies in this proposed rule would
improve the quality and value of care
provided to Medicare beneficiaries. For
example, several of the new quality
measures include patient-reported
outcome-based measures, which could
be used to help patients make more
informed decisions about treatment
options. Patient-reported outcome-based
measures provide information on a
patient’s health status from the patient’s
point of view and could also provide
valuable insights on factors such as
quality of life, functional status, and
overall disease experience, which
would 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.
H. Estimating Regulatory
Familiarization Costs
If regulations impose administrative
costs on private entities, such as the
time needed to read and interpret this
rulemaking, 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
quality Care’’ (August 24, 2023). Available at
https://www.cms.gov/newsroom/press-releases/
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year’s proposed rule. We acknowledged
that this assumption may understate or
overstate the costs of reviewing this
rulemaking. 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
this year’s proposed rule.
We also recognized that different
types of entities are in many cases
affected by mutually exclusive sections
of this proposed rule, and therefore for
the purposes of our estimate we assume
that each reviewer reads approximately
50 percent of the rulemaking.
Using the wage information from the
BLS for medical and health service
managers (Code 11–9111), we estimate
that the cost of reviewing this
rulemaking 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 proposed 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 21,677,265 ($984.48 ×
22,019 reviewers on this year’s
proposed rule).
As for the Medicare Diabetes
Prevention Program, given that we tried
to align this rulemaking as much as
possible with the CDC DPRP Standards,
there should be minimal regulatory
familiarization costs. This rulemaking
impacts only enrolled MDPP suppliers
and eligible beneficiaries who have
started the MDPP program or are
interested in enrolling in MDPP.
I. Accounting Statement
As required by OMB Circular A–4
(available at https://
www.whitehouse.gov/wp-content/
uploads/legacy_drupal_files/omb/
circulars/A4/a-4.pdf), in Tables 146
through 148 (Accounting Statements),
we have prepared an accounting
statement. This estimate includes
growth in incurred benefits from CY
2024 to CY 2025 based on the FY 2025
President’s Budget baseline.
medicare-shared-savings-program-saves-medicaremore-18-billion-2022-and-continues-deliver-high.
832 Id.
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62207
TABLE 146: Accounting Statement: Classification of Estimated Expenditures
CY 2025 Annualized Monetized Transfers
Estimated decrease in expenditures of $1.8 billion for
PFS CF u date.
Federal Government to physicians, other practitioners
and providers and suppliers who receive payment
under Medicare.
From Whom To Whom?
TABLE 147: Accounting Statement: Classification of Estimated Costs, Transfer, and
Savings
-$0.4 billion
CY 2025 Annualized Monetized Transfers of
beneficia cost coinsurance.
From Whom to Whom?
Beneficiaries to Federal Government.
TABLE 148: Accounting Statement for Provisions for Medicare Shared Savings Program
(CYs 2025-2034) ($ Millions)
Category
BENEFITS
Annualized monetized:
Discount rate: 2%
Primary
Estimate
Minimum
Estimate
-$12.6 million
-$148.9 million
Maximum
Estimate
Source Citation
Tables 132 through
134; summarized in
total in Table 135
Notes: Negative values reflect reduction in Federal net cost resulting from care management by ACOs. Estimates
may be a combination of benefits and transfers. To the extent that the incentives created by Medicare payments
change the amount ofresources society uses in providing medical care, the more accurate categorization of effects
would be as costs (positive values) or benefits/cost savings (negative values), rather than as transfers.
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42 CFR Part 401
Claims, Freedom of information,
Health facilities, Medicare, Privacy.
42 CFR Part 405
Administrative practice and
procedure, Diseases, Health facilities,
Health professions, Medical devices,
Medicare, Reporting and recordkeeping
requirements, Rural areas, and X-rays.
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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 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
Emergency medical services, Health
facilities, Health professions, Medicare,
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42 CFR Part 425
Administrative practice and
procedure, Health facilities, Health
professions, Medicare, Reporting and
recordkeeping requirements.
42 CFR Part 427
Administrative practice and
procedure, Biologics, Inflation rebates,
Medicare, Prescription drugs.
42 CFR Part 428
Administrative practice and
procedure, Biologics, Inflation rebates,
Medicare, Prescription drugs.
42 CFR Part 491
Grant programs—health, Health
facilities, Medicaid, Medicare,
Reporting and recordkeeping
requirements, Rural areas.
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:
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EP31JY24.199
List of Subjects
42 CFR Part 411
Diseases, Medicare, Reporting and
recordkeeping requirements.
Reporting and recordkeeping
requirements.
EP31JY24.198
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 June 25,
2024.
42 CFR Part 410
Diseases, Health facilities, Health
professions, Laboratories, Medicare,
Reporting and recordkeeping
requirements, Rural areas, X-rays.
EP31JY24.197
J. Conclusion
$92.6 million
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PART 401—GENERAL
ADMINISTRATIVE REQUIREMENTS
Authority: 42 U.S.C. 263a, 405(a), 1302,
1320b–12, 1395x, 1395y(a), 1395ff, 1395hh,
1395kk, 1395rr, and 1395ww(k).
1. The authority citation for part 401
is revised to read as follows:
■
■
Authority: 42 U.S.C. 1302, 1395hh,
1395w–5, and 1395kk–2.
2. Section 401.305 is amended by
revising paragraphs (b)(1) introductory
text and (b)(2) introductory text and
adding paragraph (b)(3) to read as
follows:
■
§ 401.305 Requirements for reporting and
returning of overpayments.
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*
*
*
*
*
(b) * * *
(1) Except as provided in paragraphs
(b)(2) and (3) of this section, a person
who has received an overpayment must
report and return the overpayment by
the later of either of the following:
*
*
*
*
*
(2) The deadline for returning
overpayments will be suspended (or
will continue to be suspended following
the completion of a timely, good faith
investigation in accordance with
paragraph (b)(3) of this section) when
any of the following occurs:
*
*
*
*
*
(3)(i) The deadline for reporting and
returning overpayments will be
suspended when both of the following
occurs:
(A) A person has identified an
overpayment but has not yet completed
a good-faith investigation to determine
the existence of related overpayments
that may arise from the same or similar
cause or reason as the initially
identified overpayment; and
(B) The person conducts a timely,
good-faith investigation to determine
whether related overpayments exist.
(ii) If the conditions of paragraph
(b)(3)(i) of this section are satisfied, the
deadline for reporting and returning the
initially identified overpayment and
related overpayments that arise from the
same or similar cause or reason as the
initially identified overpayment will
remain suspended until the earlier of:
(A) The date that the investigation of
related overpayments has concluded
and the aggregate amount of the initially
identified overpayments and related
overpayments is calculated; or
(B) The date that is 180 days after the
date on which the initial identified
overpayment was identified.
*
*
*
*
*
PART 405—FEDERAL HEALTH
INSURANCE FOR THE AGED AND
DISABLED
3. The authority citation for part 405
continues to read as follows:
■
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4. Section 405.2410 is amended by
revising paragraphs (c)(1) and (2) to read
as follows:
§ 405.2410 Application of Part B
deductible and coinsurance.
*
*
*
*
*
(c) * * *
(1) For RHCs, the coinsurance amount
is determined as described in paragraph
(b)(1) of this section; or
(2) For FQHCs, the coinsurance
amount is 20 percent of the lesser of—
(i) The FQHC’s actual charge; or
(ii) The payment determined under
§ 405.2462(j)(2).
■ 5. Section 405.2462 is amended by—
■ a. In paragraphs (f) heading, (f)(1)
introductory text, (f)(2), and (g)(1)(ii),
removing ‘‘grandfathered’’ and adding
in its place ‘‘historically excepted’’; and
■ b. Revising and republishing
paragraph (j).
The revisions and republications read
as follows:
§ 405.2462
services.
Payment for RHC and FQHC
*
*
*
*
*
(j) Payment amount for intensive
outpatient services. (1) An RHC is paid
the payment rate determined under
§ 419.21(a) of this chapter for services
described under § 410.44 of this chapter.
There are no adjustments to this rate.
(i) If the deductible has been fully met
by the beneficiary prior to the RHC
service, Medicare pays eighty (80)
percent of the payment amount
determined under this paragraph (j)(1).
(ii) If the deductible has not been fully
met by the beneficiary prior to the RHC
service, Medicare pays eighty (80)
percent of the difference between the
remaining deductible and the payment
amount determined under this
paragraph (j)(1); or
(iii) If the deductible has not been
fully met by the beneficiary prior to the
RHC service, no payment is made to the
RHC if the deductible is equal to or
exceeds the payment amount
determined under this paragraph (j)(1).
(2) FQHCs are paid the payment rate
determined under § 419.21(a) of this
chapter for services described under
§ 410.44 of this chapter. There are no
adjustments to this rate, except that
historically excepted tribal FQHCs are
paid pursuant to paragraph (j)(2)(ii) of
this section.
(i) Medicare pays eighty (80) percent
of the lesser of the FQHC’s actual charge
or the payment rate determined under
paragraph (j)(1)(ii) of this section; or
(ii) Medicare pays eighty (80) percent
of the lesser of a historically excepted
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tribal FQHC’s actual charge or the
amount described under paragraphs
(f)(2) and (3) of this section.
(iii) No deductible is applicable to
FQHC services.
■ 6. Section 405.2463 is amended by—
■ a. Revising paragraph (b)(3)
introductory text;
■ b. In paragraph (c)(4) introductory
text, removing ‘‘grandfathered’’ and
adding in its place ‘‘historically
excepted’’.
The revision reads as follows:
§ 405.2463
What constitutes a visit.
*
*
*
*
*
(b) * * *
(3) Visit-Mental health. A mental
health visit is a face-to-face 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 in-person mental health
service, beginning January 1, 2026,
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:
*
*
*
*
*
■ 7. Section 405.2464 is amended by
revising paragraphs (c) and (d) and
adding paragraphs (g) and (h) to read as
follows:
§ 405.2464
*
Payment rate.
*
*
*
*
(c) Payment for care coordination
services. RHCs and FQHCs are paid for
the non-face-to-face care management
work involved in coordinating care.
(1) For Chronic Care Management
(CCM) services furnished between
January 1, 2016, and December 31, 2017,
payment to RHCs and FQHCs is based
on the physician fee schedule national
non-facility payment rate.
(2) For psychiatric collaborative care
model (CoCM) services furnished on or
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after January 1, 2018, payment is based
on the average of the national nonfacility PFS payment rate set for each
psychiatric CoCM service and updated
annually based on the PFS amounts.
(3) For CCM and general Behavioral
Health Integration (BHI) services
furnished between January 1, 2018, and
December 31, 2020, payment is based on
the average of the national non-facility
PFS payment rate set for each CCM and
general BHI service and updated
annually based on the PFS amounts.
(4) For CCM, general BHI, and
Principal Care Management (PCM)
services furnished between January 1,
2021, and December 31, 2022, payment
is based on the average of the national
non-facility PFS payment rate set for
each CCM, general BHI, and PCM
service and updated annually based on
the PFS amounts.
(5) For CCM, general BHI, PCM,
Chronic Pain Management (CPM)
services furnished between January 1,
2023, and December 31, 2023, payment
is based on the average of the national
non-facility PFS payment rate set for
each CCM, general BHI, PCM and CPM
service and updated annually based on
the PFS amounts.
(6) For CCM, general BHI, PCM, CPM,
Remote Physiologic Monitoring (RPM),
Remote Therapeutic Monitoring (RTM),
Community Health Integration (CHI),
Principal Illness Navigation (PIN), and
PIN—Peer Support services furnished
between January 1, 2024, and December
31, 2024, the payment amount is based
on a weighted average of each CCM,
general BHI, PCM, CPM, RPM, RTM,
CHI, PIN, and PIN—Peer Support
service using the most recently available
PFS utilization data.
(7) For CCM, general BHI, PCM, CPM,
RPM, RTM, CHI, PIN, PIN—Peer
Support, and Advance Primary Care
Management services furnished on or
after January 1, 2025, payment is based
on the PFS national non-facility
payment rate.
(d) Payment for FQHCs that are
authorized to bill as historically
excepted tribal FQHCs. Historically
excepted tribal FQHCs are paid at the
outpatient per visit rate for Medicare as
set annually by the Indian Health
Service for each beneficiary visit for
covered services. There are no
adjustments to this rate.
*
*
*
*
*
(g) Payment for non-behavioral health
telecommunication technology services.
For an encounter furnished using
interactive, real-time, audio and video
telecommunications technology or for
certain audio-only interactions in cases
where the patient is not capable of, or
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does not consent to, the use of video
technology services that are not
described in § 405.2463(b)(3), payment
to RHCs and FQHCs are subject to the
national average payment rates for
comparable services under the
physician fee schedule (PFS) and costs
associated with these services shall not
be used in determining payments under
the RHC all-inclusive rate or the FQHC
prospective payment system.
(h) Payment for drugs covered as
additional preventive services (DCAPS).
For drugs covered as additional
preventive services, as defined at
§ 410.64 of this subchapter, and for the
administration and supplying fees for
those drugs, payment to RHCs or FQHCs
is 100 percent of the Medicare payment
amount per § 405.2410(b) and
§ 410.152(l)(11) of this chapter, subject
to the payment limitations described at
§ 410.152(o) of this chapter.
■ 8. Section 405.2466 is amended by
revising paragraph (b)(1)(iv) to read as
follows:
§ 405.2466
Annual reconciliation.
*
*
*
*
*
(b) * * *
(1) * * *
(iv) For RHCs and FQHCs, payment
for pneumococcal, influenza, hepatitis B
and COVID–19 vaccine and their
administration is 100 percent of
Medicare reasonable cost.
*
*
*
*
*
§ 405.2469
[Amended]
9. Section 405.2469 is amended in
paragraph (a)(2) by removing
‘‘grandfathered’’ and adding in its place
‘‘historically excepted’’.
■
PART 410—SUPPLEMENTARY
MEDICAL INSURANCE (SMI)
BENEFITS
10. The authority citation for part 410
continues to read as follows:
■
Authority: 42 U.S.C. 1302, 1395m,
1395hh, 1395rr, and 1395ddd.
11. Section 410.26 is amended by
revising paragraph (a)(2) to read as
follows:
■
§ 410.26 Services and supplies incident to
a physician’s professional services:
Conditions.
(a) * * *
(2) Direct supervision means, except
as provided in paragraphs (a)(2)(i) and
(ii) of this section, the level of
supervision by the physician (or other
practitioner) of auxiliary personnel as
defined in § 410.32(b)(3)(ii). For the
following services furnished after
December 31, 2025, the presence of the
physician (or other practitioner)
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62209
required for direct supervision shall
include virtual presence through audio/
video real-time communications
technology (excluding audio-only):
(i) Services furnished incident to a
physician of other practitioner’s service
provided by auxiliary personnel
employed by the billing practitioner and
working under their direct supervision
and for which the underlying
Healthcare Common Procedure Coding
System (HCPCS) code has been assigned
a PC/TC indicator of ‘5’.
(ii) Office or other outpatient visits for
the evaluation and management of an
established patient that may not require
the presence of a physician or other
qualified health care practitioner.
*
*
*
*
*
■ 12. Section 410.30 is amended by
revising paragraph (a) to read as follows:
§ 410.30 Prescription drugs used in
immunosuppressive therapy.
(a) Scope. Payment may be made for
prescription drugs used in
immunosuppressive therapy that meet
one of the following conditions:
(1) The drug has been approved for
marketing by the FDA and—
(i) The approved labeling includes an
indication for preventing or treating the
rejection of a transplanted organ or
tissue; or
(ii) The approved labeling includes
the indication for use in conjunction
with immunosuppressive drugs to
prevent or treat rejection of a
transplanted organ or tissue.
(2) The drug has been approved for
marketing by FDA and determined by a
Medicare Administrative Contractor
(MAC) (in accordance with part 421,
subpart C, of this chapter), in processing
a Medicare claim, to be reasonable and
necessary for the specific purpose of
preventing or treating the rejection of a
patient’s transplanted organ or tissue, or
for use in conjunction with
immunosuppressive drugs for the
purpose of preventing or treating the
rejection of a patient’s transplanted
organ or tissue. (In making these
determinations, the MACs may consider
factors such as authoritative drug
compendia, current medical literature,
recognized standards of medical
practice, and professional medical
publications.)
(3) The drug is a compounded
formulation with active ingredients
derived only from a drug described in
paragraph (a)(1) or (2) of this section
and is orally or enterally administered.
*
*
*
*
*
■ 13. Section 410.32 is amended by
revising paragraph (b)(3)(ii) to read as
follows:
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§ 410.32 Diagnostic x-ray tests, diagnostic
laboratory tests, and other diagnostic tests:
Conditions.
*
*
*
*
*
(b) * * *
(3) * * *
(ii) Direct supervision in the office
setting means that 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 service. It does not
mean that the physician (or other
supervising practitioner) must be
present in the room when the service is
performed. Through December 31, 2025,
the presence of the physician (or other
practitioner) includes virtual presence
through audio/video real-time
communications technology (excluding
audio-only).
*
*
*
*
*
■ 14. Section 410.37 is amended by—
■ a. In paragraph (a)(1)(iv), removing the
text ‘‘barium enemas’’ and adding in its
place ‘‘computed tomography
colonography’’;
■ b. Revising paragraph (a)(4);
■ c. In paragraph (e)(2), removing the
text ‘‘barium enema’’ and adding in its
place ‘‘computed tomography
colonography’’;
■ d. In paragraph (g)(2), removing the
text ‘‘barium enema’’ and adding in its
place ‘‘computed tomography
colonography’’;
■ e. Revising paragraphs (h), (i), and (k).
The revisions read as follows:
§ 410.37 Colorectal cancer screening
tests: Conditions for and limitations on
coverage.
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*
*
*
*
*
(a) * * *
(4) Screening computed tomography
colonography means a test that uses Xrays and computers to produce images
of the entire colon (including image
processing and a physician’s
interpretation of the results of the
procedure).
*
*
*
*
*
(h) Conditions for coverage of
screening computed tomography
colonography. Medicare Part B pays for
a screening computed tomography
colonography if it is ordered in writing
by the beneficiary’s attending physician
who is a doctor of medicine or
osteopathy (as defined in section
1861(r)(1) of the Act); or by a physician
assistant, nurse practitioner, or clinical
nurse specialist (as defined in section
1861(aa)(5) of the Act).
(i) Limitations on coverage of
screening computed tomography
colonography. (1) In the case of an
individual age 45 or over who is not at
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high risk of colorectal cancer, payment
may be made for a screening computed
tomography colonography performed
after at least 59 months have passed
following the month in which the last
screening computed tomography
colonography or 47 months have passed
following the month in which the last
screening flexible sigmoidoscopy or
screening colonoscopy was performed.
(2) In the case of an individual who
is at high risk for colorectal cancer,
payment may be made for a screening
computed tomography colonography
performed after at least 23 months have
passed following the month in which
the last screening computed tomography
colonography or the last screening
colonoscopy was performed.
*
*
*
*
*
(k) A complete colorectal cancer
screening. Effective January 1, 2025,
colorectal cancer screening tests include
a follow-on screening colonoscopy after
a Medicare covered non-invasive stoolbased colorectal cancer screening test or
blood-based biomarker colorectal cancer
screening test returns a positive result.
The instance of the follow-on screening
colonoscopy in the context of a
complete colorectal cancer screening
must not apply to the frequency
limitations for colorectal cancer
screening.
■ 15. 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 general
supervision (or as specified otherwise)
of, an occupational therapist in private
practice as described in paragraph (c) of
this section; or
*
*
*
*
*
(c) * * *
(2) Supervision of occupational
therapy services. Except as otherwise
provided in this paragraph (c)(2),
occupational therapy services are
performed by, or under the general
supervision of, an occupational
therapist in private practice. All services
not performed personally by the
therapist must be performed by
employees of the practice, generally
supervised by the therapist, and
included in the fee for the therapist’s
services. Occupational therapy 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
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the direct supervision of the
occupational therapist.
*
*
*
*
*
■ 16. 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 general
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 (c)(2), physical
therapy services are performed by, or
under the general supervision of, a
physical therapist in private practice.
All services not performed personally
by the therapist must be performed by
employees of the practice, generally
supervised by the therapist, and
included in the fee for the therapist’s
services. Physical therapy 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.
*
*
*
*
*
■ 17. Section 410.63 is amended by—
■ a. Revising paragraph (a) introductory
text;
■ b. Removing the word ‘‘and’’ at the
end of paragraph (a)(2)(ii);
■ c. Removing the period at the end of
paragraph (a)(2)(iii) and adding in its
place ‘‘; and’’;
■ d. Adding paragraph (a)(2)(iv); and
■ e. Revising paragraphs (b) and (c)(1).
The revisions and addition read as
follows:
§ 410.63 Hepatitis B vaccine and blood
clotting factors: Conditions.
*
*
*
*
*
(a) Hepatitis B vaccine: Conditions.
Effective January 1, 2025, hepatitis B
vaccinations are reasonable and
necessary for the prevention of illness
for those individuals who are at high or
intermediate risk of contracting
hepatitis B as listed in paragraphs (a)(1)
through (3) of this section:
*
*
*
*
*
(2) * * *
(iv) Individuals who have not
previously received a completed
hepatitis B vaccination series or whose
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unknown.
*
*
*
*
*
(b) Blood clotting factors: Conditions.
Effective July 18, 1984, blood clotting
factors that are self-administered and
control bleeding for hemophilia patients
competent to use these factors without
medical or other supervision, and items
related to the administration of those
factors. The amount of clotting factors
covered under this provision is
determined by the carrier based on the
historical utilization pattern or profile
developed by the carrier for each
patient, and based on consideration of
the need for a reasonable reserve supply
to be kept in the home in the event of
emergency or unforeseen circumstance.
(c) * * *
(1) Effective January 1, 2005, a
furnishing fee of $0.14 per unit of
clotting factor is paid to entities that
furnish blood clotting factors, as
described in paragraph (b) of this
section, unless the costs associated with
furnishing the clotting factor are paid
through another payment system, for
example, hospitals that furnish clotting
factor to patients during a Part A
covered inpatient hospital stay, or
practitioners that furnish clotting factor
to patients in an outpatient setting and
are paid for under the Physician Fee
Schedule.
*
*
*
*
*
■ 18. Section 410.67 is amended in
paragraph (b), in the definition of
‘‘Opioid use disorder treatment
service,’’ by revising paragraphs (vi) and
(vii) to read as follows:
§ 410.67 Medicare coverage and payment
of Opioid use disorder treatment services
furnished by Opioid treatment programs.
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*
*
*
*
(b) * * *
Opioid use disorder treatment service
* * *
(vi) Intake activities, including initial
medical examination services required
under § 8.12(f)(2) of this title and initial
assessment services required under
§ 8.12(f)(4) of this title.
(A) For intake activities furnished via
communications technology, the
following flexibilities apply:
(1) Services to initiate treatment with
buprenorphine may be furnished via
two-way interactive audio-video
communication technology, as clinically
appropriate, and in compliance with all
applicable requirements. In cases where
audio-video communications
technology is not available to the
beneficiary, services to initiate
treatment with buprenorphine may be
furnished using audio-only telephone
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calls if all other applicable requirements
are met.
(2) Services to initiate treatment with
methadone may be furnished via twoway interactive audio-video
communication technology, as clinically
appropriate, and in compliance with all
applicable requirements, if an OTP
determines that an adequate evaluation
of the patient can be accomplished
through audio-video communication
technology.
(B) [Reserved]
(vii) Periodic assessment services
required under § 8.12(f)(4) of this title,
that are furnished during a face-to-face
encounter, including services furnished
via two-way interactive audio-video
communication technology, as clinically
appropriate, and in compliance with all
applicable requirements. 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.
*
*
*
*
*
■ 19. Section 410.78 is amended by
revising paragraph (a)(3) read as follows:
§ 410.78
Telehealth services.
(a) * * *
(3) Interactive telecommunications
system means, except as otherwise
provided in this paragraph (a)(3),
multimedia communications equipment
that includes, at a minimum, audio and
video equipment permitting two-way,
real-time interactive communication
between the patient and distant site
physician or practitioner. Interactive
telecommunications system may also
include two-way, real-time audio-only
communication technology for any
telehealth service furnished to a patient
in their home if the distant site
physician or practitioner is technically
capable of using an interactive
telecommunications system as defined
in the previous sentence, but the patient
is not capable of, or does not consent to,
the use of video technology. The
following modifiers must be appended
to a claim for telehealth services
furnished using two-way, real-time
audio-only communication technology
to verify that the conditions set forth in
the prior sentence have been met:
(i) Current Procedural Terminology
(CPT) modifier ‘‘93’’; and
(ii) For rural health clinics (RHCs) and
federally qualified health centers
(FQHCs), Medicare modifier ‘‘FQ’’.
*
*
*
*
*
■ 20. Section 410.79 is amended by—
■ a. In paragraph (b):
■ i. Removing the definition of
‘‘Combination delivery’’;
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ii. Adding the definitions of
‘‘Combination with an online
component,’’ ‘‘In-person with a distance
learning component,’’ and ‘‘Online’’ in
alphabetical order;
■ iii. Removing the definition of
‘‘Online delivery’’; and
■ iv. Revising the definition of ‘‘Set of
MDPP services’’; and
■ b. Revising paragraphs (d)(1)
introductory text, (e)(3)(iii)(C),
(e)(3)(iv)(F)(3), and (e)(3)(v)(F)(2).
The additions and revisions read as
follows:
■
§ 410.79 Medicare Diabetes Prevention
Program expanded model: Conditions of
coverage.
*
*
*
*
*
(b) * * *
Combination with an online
component refers to sessions that are
delivered as a combination of online
(non-live) with in-person or distance
learning.
*
*
*
*
*
In-person with a distance learning
component refers to DPP sessions that
are delivered in person by trained
Coaches where participants have the
option of attending sessions via MDPP
distance learning.
*
*
*
*
*
Online means sessions that are
delivered 100 percent through the
internet via phone, tablet, or laptop in
an asynchronous (non-live) classroom
where participants are experiencing the
content on their own time without a live
(including non-artificial intelligence
(AI)) Coach teaching the content. These
sessions must be furnished in a manner
consistent with the DPRP Standards for
online sessions. Live Coach interaction
must be offered to each participant
during weeks when the participant has
engaged with content. Emails and text
messages can count toward the
requirement for live Coach interaction if
there is bi-directional communication
between the Coach and participant. Chat
bots and AI forums do not count as live
Coach interaction.
*
*
*
*
*
Set of MDPP services means the series
of MDPP sessions, composed of core
sessions and core maintenance sessions,
and subject to paragraph (c)(3) of this
section offered over the course of the
MDPP services period.
*
*
*
*
*
(d) * * *
(1) An MDPP supplier may offer a
make-up session to an MDPP
beneficiary who missed a regularly
scheduled session. MDPP make-up
sessions may only use in-person or
distance learning delivery. If an MDPP
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supplier offers one or more make-up
sessions to an MDPP beneficiary, each
such session must be furnished in
accordance with the following
requirements:
*
*
*
*
*
(e) * * *
(3) * * *
(iii) * * *
(C) Self-reported weight
measurements from the at-home digital
scale of the MDPP beneficiary. Selfreported 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,
or the MDPP supplier receives 2 (two)
date-stamped photos or a video
recording of the beneficiary’s weight,
with the beneficiary visible on the scale,
submitted by the MDPP beneficiary to
the MDPP supplier. Photo or video must
clearly document the weight of the
MDPP beneficiary as it appears on their
digital scale on the date associated with
the billable MDPP session. If choosing
to submit 2 photos, one photo must
show the beneficiary’s weight on the
digital scale, the second photo must
show the beneficiary visible in their
home, and both photos must be datestamped.
*
*
*
*
*
(iv) * * *
(F) * * *
(3) No more than 12 virtual sessions
offered monthly during the ongoing
maintenance session intervals, months
13 through 24 for beneficiaries enrolled
before January 1, 2022.
*
*
*
*
*
(v) * * *
(F) * * *
(2) For an MDPP beneficiary who
began receiving the Set of MDPP
services on or after January 1, 2021, has
suspended services during an applicable
1135 waiver event, the MDPP supplier
must use the baseline weight recorded
at the beneficiary’s first core session.
*
*
*
*
*
■ 21. Section 410.152 is amended by
adding paragraph (o) to read as follows:
§ 410.152
Amounts of payment.
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*
*
*
*
(o) Amount of payment: Drugs
covered as additional preventive
services (DCAPS). For a drug covered as
an additional preventive service, as
defined at § 410.64, payment must be
made as follows:
(1) Payment for a drug covered as an
additional preventive service, per
section 1861(a)(1)(W)(ii) of the Act and
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paragraphs (l)(11) of this section and
§ 410.160(b)(13), is 100 percent of the
lesser of—
(i) The actual charge on the claim for
program benefits; or
(ii) The amount determined under the
fee schedule as described in paragraph
(o)(3) of this section.
(2) Payment for the supplying or
administration of a drug covered as an
additional preventive service per
section 1861(a)(1)(W)(ii) of the Act and
paragraphs (l)(11) of this section and
§ 410.160(b)(13), is 100 percent of the
lesser of—
(i) The actual charge on the claim for
program benefits; or
(ii) The amount determined under the
fee schedule as described in paragraph
(o)(4) of this section.
(3) The payment limit for a drug
covered as an additional preventive
service, as defined at § 410.64, appears
on the DCAPS fee schedule and is
determined as follows:
(i) If Average Sales Price (ASP) data
is available for the drug, consistent with
part 414, subpart J, of this chapter, then
the payment limit is determined using
the methodology set forth in section
1847A of the Act and according to the
provisions in part 414, subpart K, of this
chapter.
(ii) If ASP data is not available, then
the payment limit is determined
according to an average of the most
recently published National Average
Drug Acquisition Cost (NADAC) prices
for the drug.
(iii) If ASP data and NADAC prices
are not available, then the payment limit
is determined according to an average of
the most recently published
pharmaceutical pricing data for the drug
as included in the Federal Supply
Schedule (FSS), as managed by the
Department of Veterans Affairs per 48
CFR part 38.
(iv) If ASP data, NADAC prices, and
FSS pharmaceutical prices are not
available, then the payment limit is the
invoice price determined by the MAC.
(4) The payment limits for supplying
and administering a drug covered as an
additional preventive service, as defined
at § 410.64, appear on the DCAPS fee
schedule and are determined as follows:
(i) For a drug that is supplied by a
pharmacy, the payment limit for a
supplying fee is as follows:
(A) For the first prescription that the
pharmacy provides to a beneficiary in a
30-day period for a drug covered as an
additional preventive service, $24.
(B) For all subsequent prescriptions
that the pharmacy provides to a
beneficiary in a 30-day period for a drug
covered as an additional preventive
service, $16.
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(ii) For a drug that is administered by
a physician or a non-physician
practitioner, the payment limit for
administration is set in accordance with
part 414, subpart B, of this chapter. This
fee is not subject to the Part B
deductible, per § 410.160(b)(13). This
fee is equal to 100 percent of the
Medicare payment amount established
under the applicable payment
methodology, per paragraph (l)(11) of
this section.
PART 411—EXCLUSIONS FROM
MEDICARE AND LIMITATIONS ON
MEDICARE PAYMENT
22. 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.
23. Section 411.15 is amended by
revising paragraph (i)(3)(i)(A) to read as
follows:
■
§ 411.15 Particular services excluded from
coverage.
*
*
*
*
*
(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,
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 dialysis services in the
treatment of end stage renal disease.
*
*
*
*
*
PART 414—PAYMENT FOR PART B
MEDICAL AND OTHER HEALTH
SERVICES
24. The authority citation for part 414
continues to read as follows:
■
Authority: 42 U.S.C. 1302, 1395hh, and
1395rr(b)(l).
25. Section 414.84 is amended by—
a. In paragraph (a), removing the
definition of ‘‘Bridge payment’’;
■ b. Revising paragraphs (b)(1)
introductory text and (b)(2) introductory
text;
■ c. Adding paragraph (c)(4);
■ d. Removing paragraph (d);
■
■
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e. Redesignating paragraph (e) as
paragraph (d); and
■ f. Revising newly redesignated
paragraph (d).
The revisions and addition read as
follows:
■
§ 414.84
Payment for MDPP services.
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*
*
*
*
(b) * * *
(1) Performance Goal 1: Achieves the
required minimum 5-percent weight
loss. CMS makes a performance
payment to an MDPP supplier for an
MDPP beneficiary who achieves the
required minimum weight loss as
measured in-person or during a distance
learning session during a core session or
core maintenance session furnished by
that supplier. The amount of this
performance payment is determined as
follows:
*
*
*
*
*
(2) Performance Goal 2: Achieves 9percent weight loss. CMS makes a
performance payment to an MDPP
supplier for an MDPP beneficiary who
achieves at least a 9-percent weight loss
as measured in-person or in a distance
learning session during a core session or
core maintenance session furnished by
that supplier. The amount of this
performance payment is determined as
follows:
*
*
*
*
*
(c) * * *
(4) Current Procedural Terminology
(CPT) Modifier 79 (repeat services by
same physician) must be appended to
any claim for G9886 or G9887 to
identify a MDPP make-up session that
was held on the same day as a regularly
scheduled MDPP session.
(d) Updating performance payments
and attendance payments. The
performance payments and attendance
payments 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 (BLS) and
applied based on one decimal place of
precision. The annual MDPP services
payment update will be published by
CMS transmittal.
■ 26. Section 414.502 is amended by
revising the definitions of ‘‘Data
collection period’’ and ‘‘Data reporting
period’’ to read as follows:
§ 414.502
Definitions.
*
*
*
*
Data collection period is the 6 months
from January 1 through June 30, during
20:32 Jul 30, 2024
§ 414.504
[Amended]
27. Section 414.504 is amended in
paragraph (a)(1) by removing the
reference ‘‘January 1, 2024’’ and adding
in its place the reference ‘‘January 1,
2025’’.
■ 28. Section 414.507 is amended by
revising paragraphs (d) introductory text
and (d)(7) and adding paragraph (d)(10)
to read as follows:
■
§ 414.507 Payment for clinical diagnostic
laboratory tests.
*
*
*
*
*
(d) Phase-in of payment reductions.
For years 2018 through 2027, 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—
*
*
*
*
*
(7) 2024—0.0 percent of the payment
rate established in 2023.
*
*
*
*
*
(10) 2027—15 percent of the payment
rate established in 2026.
*
*
*
*
*
■ 29. Section 414.605 is amended in the
definition of ‘‘Advanced life support,
level 2 (ALS2)’’ by adding paragraph (8)
to read as follows:
§ 414.605
Definitions.
*
*
*
*
*
Advanced life support, level 2 (ALS2)
* * *
(8) Administration of low titer O+
whole blood transfusion.
*
*
*
*
*
■ 30. Section 414.902 is amended by
revising the definition ‘‘Refundable
single-dose container or single-use
package drug’’ to read as follows:
§ 414.902
Definitions.
*
*
VerDate Sep<11>2014
which applicable information is
collected and that precedes the data
reporting period, except that for the data
reporting period of January 1, 2025,
through March 31, 2025, 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, 2025,
through March 31, 2025.
*
*
*
*
*
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*
*
*
*
Refundable single-dose container or
single-use package drug, as used in this
subpart:
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(1) Means a single source drug or
biological or a biosimilar biological
product for which payment is made
under this part and is—
(i) Furnished from a single-dose
container or single-use package based
on Food and Drug Administration
(FDA)-approved labeling or product
information; or
(ii) Furnished from an ampule for
which product labeling does not have
discard statement or language indicating
if the container is single-dose container,
single-use package, multiple-dose
container, or single-patient-use
container; or
(iii) Furnished from a container with
a total labeled volume of 2 mL or less
for which product labeling does not
have language indicating if the
container is single-dose container,
single-use package, multiple-dose
container, or single-patient-use
container.
(2) And excludes—
(i) A drug that is a therapeutic
radiopharmaceutical, a diagnostic
radiopharmaceutical, or an imaging
agent as identified in the drug’s FDAapproved labeling.
(ii) A drug for which the FDAapproved labeling for any National Drug
Code assigned to a billing and payment
code of such drug requires filtration
during the drug preparation process,
prior to dilution and administration and
that any unused portion of such drug
after the filtration process be discarded
after the completion of such filtration
process.
(iii) A drug approved or licensed by
the FDA on or after November 15, 2021,
until the last day of the sixth full quarter
for which the drug has been marketed
(as reported to CMS) for the first
National Drug Code assigned to the
billing and payment code of such drug.
(iv) A drug approved or licensed by
FDA on or after November 15, 2021 and
for which the date of first sale as
reported to CMS does not adequately
approximate the date of first payment
under Part B due to an applicable
national coverage determination, until
the last day of the sixth full quarter for
which the drug has been covered and
paid under Medicare Part B for the first
National Drug Code assigned to the
billing and payment code of such drug.
*
*
*
*
*
■ 31. Section 414.904 is amended by
adding paragraph (e)(6) and revising
paragraph (i) to read as follows:
§ 414.904 Average sales price as the basis
for payment.
*
*
*
(e) * * *
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(6) Radiopharmaceuticals furnished
in settings other than the hospital
outpatient department. Medicare
administrative contractors must
determine payment limits for
radiopharmaceuticals based on any
methodology used to determine
payment limits for
radiopharmaceuticals in place on or
prior to November 2003. Such
methodology may include, but is not
limited to, the use of invoice-based
pricing.
*
*
*
*
*
(i) Manufacturer’s average sales price
(ASP) data not available prior to the
publication deadline for quarterly
payment limits. For circumstances in
which manufacturer’s ASP data is not
available prior to the publication
deadline for quarterly payment limits as
described in this section, payment limit
must be determined as follows:
(1) For a multiple source drug (as
defined in § 414.902)—
(i) In circumstances in which negative
or zero manufacturer’s ASP data is
reported for one or more, but not all,
National Drug Codes (NDCs) associated
with a billing and payment code for that
drug for a given quarter, the payment
limit for the given quarter is calculated
using only NDCs for that drug with
positive manufacturer’s ASP data,
except in circumstances described in
paragraph (i)(1)(iii) of this section.
(ii) In circumstances in which
negative or zero manufacturer’s ASP
data is reported for all NDCs associated
with a billing and payment code for that
drug for a given quarter, the payment
limit for the given quarter is calculated
by carrying over all positive
manufacturer’s ASP data from the most
recently available previous quarter with
positive manufacturer’s ASP data for at
least one NDC until at least one NDC for
the drug has positive manufacturer’s
ASP data for a quarter.
(iii) In circumstances in which
manufacturer’s ASP data is not available
and the unavailability of the
manufacturer’s ASP data results in a
significant change in the ASP payment
limit compared to the previous quarter,
the payment limit is calculated by
carrying over the most recent available
ASP data for the individual NDC(s),
adjusted by the weighted average of the
change in the manufacturer’s ASP data
for the NDCs that were reported for both
the most recently available previous
quarter and the current quarter.
(2) For a single source drug, excluding
biosimilar biological products (both as
defined in § 414.902)—
(i) In circumstances in which negative
or zero manufacturer’s ASP data is
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reported for one or more, but not all,
NDCs associated with a billing and
payment code for that drug for a given
quarter, the payment limit for the given
quarter is calculated using only NDCs
for that drug with positive
manufacturer’s ASP data.
(ii) In circumstances in which
negative or zero manufacturer’s ASP
data is reported for all NDCs associated
with a billing and payment code for that
drug for a given quarter, the payment
limit for the given quarter is the lesser
of the following until at least one NDC
for the drug has positive manufacturer’s
ASP data for a quarter:
(A) 106 percent of the volumeweighted average of the most recent
available positive manufacturer’s ASP
data from a previous quarter in which
at least one NDC for the drug has
positive manufacturer’s ASP data for the
quarter. If the payment limit from such
quarter was based on 106 percent of the
wholesale acquisition cost because of
the application of paragraph (d)(1) of
this section, that payment limit is
carried over; or
(B) 106 percent of the wholesale
acquisition cost. If there is more than
one WAC per billing unit for the drug,
the payment limit is set using the lowest
WAC per billing unit.
(3) For a biosimilar biological product
(as defined in § 414.902)—
(i) In circumstances in which negative
or zero manufacturer’s ASP data is
reported for one or more, but not all,
NDCs for a given quarter, the payment
limit for the given quarter is calculated
using only NDCs with positive
manufacturer’s ASP data.
(ii) In circumstances in which
negative or zero manufacturer’s ASP
data is reported for all NDCs for a given
quarter, and other biosimilars
referencing the same reference product
report positive ASP data for the given
quarter, the payment limit for the given
quarter is the sum of the following until
at least one NDC for the drug has
positive manufacturer’s ASP data for a
quarter:
(A) the volume-weighted average of
the ASP data from all other biosimilars
of the same reference product; and
(B) Either:
(1) If the biosimilar is not a qualifying
biosimilar (as both are defined at
§ 414.902), 6 percent of the amount
determined under section 1847A(b)(4)
of the Act for the reference biological
product (as defined in § 414.902) for the
given quarter; or
(2) If the biosimilar is a qualifying
biosimilar (as both are defined at
§ 414.902), 8 percent of the amount
determined under section 1847A(b)(4)
of the Act for the reference biological
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product (as defined in § 414.902) for the
given quarter.
(iii) In circumstances in which
negative or zero manufacturer’s ASP
data is reported for all NDCs for a given
quarter and either no other biosimilars
have been approved for the same
reference product or no other
biosimilars of the same reference
product report positive manufacturer’s
ASP data for the given quarter, the
payment limit for the given quarter is
the sum of the following until at least
one NDC for the drug has positive
manufacturer’s ASP data for a quarter:
(A) The volume-weighted average of
the most recent available positive
manufacturer’s ASP data from a
previous quarter; and
(B) Either:
(1) If the biosimilar is not a qualifying
biosimilar (as both are defined at
§ 414.902), 6 percent of the amount
determined under section 1847A(b)(4)
of the Act for the reference biological
product (as defined in § 414.902) for the
given quarter; or
(2) If the biosimilar is a qualifying
biosimilar (as both are defined at
§ 414.902), 8 percent of the amount
determined under section 1847A(b)(4)
of the Act for the reference biological
product (as defined in § 414.902) for the
given quarter.
*
*
*
*
*
■ 32. Section 414.1001 is amended by—
■ a. Revising paragraph (a);
■ b. Removing paragraph (b);
■ c. Redesignating paragraphs (c) and
(d) as paragraphs (b) and (c),
respectively;
■ d. In newly redesignated paragraph
(b)(2), removing ‘‘(c)(1)’’ and adding in
its place ‘‘(b)(1)’’.
The revision reads as follows:
§ 414.1001
Basis of payment.
(a) Supplying fees. Beginning in CY
2006—
(1) A supplying fee of $24 is paid to
a pharmacy (no more often than once
every 30 days) for the first prescription
of drugs and biologicals described in
sections 1861(s)(2)(J), 1861(s)(2)(Q), and
1861(s)(2)(T) of the Act, that the
pharmacy provided to a beneficiary,
except as provided in paragraph (a)(2) of
this section.
(2) A supplying fee of $50 is paid to
pharmacy for the initial supplied
prescription of drugs and biologicals
described in section 1861(s)(2)(J) of the
Act, that the pharmacy provided to a
patient during the first 30-day period
following a transplant.
(3) A supplying fee of $16 is paid to
a pharmacy (no more often than once
every 30 days) for each prescription
following the first prescription (as
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specified in paragraphs (a)(1) and (2) of
this section) of drugs and biologicals
described in sections 1861(s)(2)(J),
1861(s)(2)(Q), and 1861(s)(2)(T) of the
Act, that the pharmacy provided to a
beneficiary.
(4) A separate supplying fee is paid to
a pharmacy for each prescription of
drugs and biologicals described in
sections 1861(s)(2)(J), 1861(s)(2)(Q), and
1861(s)(2)(T) of the Act.
*
*
*
*
*
■ 33. Section 414.1305 is amended in
the definition of ‘‘Attribution-eligible
beneficiary’’ by revising paragraph (6) to
read as follows:
§ 414.1305
Definitions.
*
*
*
*
*
Attribution-eligible beneficiary * * *
(6) Has a minimum of one claim for
any covered professional service
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.
*
*
*
*
*
■ 34. Section 414.1325 is amended by
adding paragraphs (a)(1)(i) through (iii)
and (f) to read as follows:
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§ 414.1325
Data submission requirements.
(a) * * *
(1) * * *
(i) For the quality performance
category, a data submission must
include numerator and denominator
data for at least one MIPS quality
measure from the final list of MIPS
quality measures.
(ii) For the improvement activities
performance category, a data submission
must include a response of ‘‘yes’’ for at
least one activity in the MIPS
improvement activities inventory.
(iii) For the Promoting
Interoperability performance category, a
data submission must include all of the
following elements:
(A) Performance data, including any
claim of an applicable exclusion, for the
measures in each objective, as specified
by CMS;
(B) Required attestation statements, as
specified by CMS;
(C) CMS EHR Certification ID (CEHRT
ID) from the Certified Health IT Product
List (CHPL); and
(D) The start date and end date for the
applicable performance period as set
forth in § 414.1320.
*
*
*
*
*
(f) Treatment of multiple data
submissions. (1) For multiple data
submissions received in the quality and
improvement activities performance
categories in accordance with
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paragraphs (a)(1)(i) and (ii) of this
section for an individual MIPS eligible
clinician, group, subgroup, or virtual
group from submitters in multiple
organizations (for example, qualified
registry, practice administrator, or EHR
vendor), CMS will calculate and score
each submission received and assign the
highest of the scores. For multiple data
submissions received for an individual
MIPS eligible clinician, group,
subgroup, or virtual group from one or
multiple submitters in the same
organization, CMS will score the most
recent submission.
(2) For multiple data submissions
received for the Promoting
Interoperability performance category,
CMS will calculate a score for each data
submission received and assign the
highest of the scores.
■ 35. Section 414.1330 is amended by
adding paragraph (c) to read as follows.
§ 414.1330
Quality performance category.
*
*
*
*
*
(c)(1) CMS uses the following criteria
to determine the removal of a quality
measure:
(i) If the Secretary determines that the
quality measure is no longer
meaningful, such as measures that are
topped out.
(ii) If a measure steward is no longer
able to maintain the quality measure.
(iii) If the quality measure reached
extremely topped out status.
(iv) If the quality measure does not
meet case minimum and reporting
volumes required for benchmarking
after being in the program for 2
consecutive CY performance periods.
(v) If the quality measure is
duplicative.
(vi) If the quality measure is not
updated to reflect current clinical
guidelines, which are not reflective of a
clinician’s scope of practice.
(vii) If the quality measure is a
process measure.
(viii) If the quality measure addresses
a measurement gap.
(ix) If the quality measure is a patientreported outcome.
(x) If the quality measure is not
available for MIPS quality reporting by
or on behalf of all MIPS eligible
clinicians.
(xi) The robustness of the quality
measure.
(xii) Consideration of the quality
measure in developing MIPS Value
Pathways (MVPs).
(2) A quality measure that otherwise
meets the criteria for removal in
paragraph (c)(1) of this section may
nonetheless be retained based on the
following considerations:
(i) Whether the removal of the process
measure impacts the number of
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measures available for a specific
specialty.
(ii) Whether the quality measure
addresses a priority area.
(iii) Whether the quality measure
promotes positive outcomes in patients.
(iv) Whether the quality measure is
designated as high priority or not.
(v) Whether the quality measure has
reached extremely topped out status.
(vi) Evaluation of the quality
measure’s performance data.
■ 36. Section 414.1335 is amended by
revising paragraph (a) introductory text
and adding paragraph (b) to read as
follows.
§ 414.1335 Data submission criteria for the
quality performance category.
(a) Criteria. Except as provided in
paragraph (b) of this section, 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:
*
*
*
*
*
(b) Special rule for the APM
Performance Pathway (APP) Plus
measure set. A MIPS eligible clinician,
group, or APM Entity that reports the
APP Plus measure set via the APP must
report on all measures included in the
APP Plus measure set, except for
administrative claims-based quality
measures as provided in
§ 414.1325(a)(2)(i).
■ 37. Section 414.1340 is amended by
revising paragraphs (a)(4), (b)(4), (d)
introductory text, and (d)(1) to read as
follows:
§ 414.1340 Data completeness criteria for
the quality performance category.
(a) * * *
(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, 2028, 2029,
and 2030.
(b) * * *
(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, 2028, 2029, and 2030.
*
*
*
*
*
(d) APM Entities, specifically
Medicare Shared Savings Program
Accountable Care Organizations that
meet 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 of
this chapter, who meet the measure’s
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denominator criteria for MIPS payment
years 2026, 2027, 2028, 2029, and 2030.
*
*
*
*
*
■ 38. Section 414.1350 is amended by
adding paragraph (e) to read as follows:
§ 414.1350
Cost performance category.
*
*
*
*
*
(e) Cost measure removal criteria.
CMS may remove a cost measure from
MIPS based on one or more of the
following factors, provided however
CMS may retain a cost measure that
meets one or more of the following
factors if CMS determines the benefit of
retaining the measure outweighs the
benefit of removing it.
(1) It is not feasible to implement the
measure specifications.
(2) A measure steward is no longer
able to maintain the cost measure.
(3) The implementation costs or
negative unintended consequences
associated with a cost measure outweigh
the benefit of its continued use in the
MIPS cost performance category.
(4) The measure specifications do not
reflect current clinical practice or
guidelines.
(5) The availability of a more
applicable measure, including a
measure that applies across settings,
applies across populations, or is more
proximal in time to desired patient
outcomes for the particular topic.
■ 39. Section 414.1355 is amended by
adding paragraph (d) to read as follows:
§ 414.1355 Improvement activities
performance category.
lotter on DSK11XQN23PROD with PROPOSALS2
*
*
*
*
*
(d) CMS may remove an improvement
activity from MIPS based on one or
more of the following factors, provided
however CMS may retain an
improvement activity that meets one or
more of the following factors if CMS
determines the benefit of retaining the
activity outweighs the benefit of
removing it:
(1) Factor 1: Activity is duplicative of
another activity.
(2) Factor 2: There is an alternative
activity with a stronger relationship to
quality care or improvements in clinical
practice.
(3) Factor 3: Activity does not align
with current clinical guidelines or
practice.
(4) Factor 4: Activity does not align
with at least one meaningful measures
area.
(5) Factor 5: Activity does not align
with the quality, cost, or Promoting
Interoperability performance categories.
(6) Factor 6: There have been no
attestations of the activity for 3
consecutive years.
(7) Factor 7: Activity is obsolete.
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40. Section 414.1365 is amended by
revising paragraphs (b)(2)(i), (c)(3)(i) and
(ii), (c)(4)(i)(A), (d)(3)(i)(A) introductory
text, (d)(3)(i)(A)(1), (d)(3)(ii)
introductory text, (d)(3)(ii)(A), and
(d)(3)(iii) to read as follows:
■
§ 414.1365
MIPS Value Pathways.
*
*
*
*
*
(b) * * *
(2) * * *
(i) For the CY 2023 through 2024
performance periods/2025 through 2026
MIPS payment years, each MVP
Participant must select an MVP, one
population health measure included in
the MVP, and any outcomes-based
administrative claims measure on which
the MVP Participant intends to be
scored. Beginning in the CY 2025
performance period/2027 MIPS
payment year, each MVP Participant
must select an MVP and any outcomesbased administrative claims measure on
which the MVP Participant intends to
be scored.
*
*
*
*
*
(c) * * *
(3) * * *
(i) For the CY 2023 and 2024
performance periods/2025 through 2026
MIPS payment years:
(A) Two medium-weighted
improvement activities.
(B) One high-weighted improvement
activity.
(C) Participation in a certified or
recognized patient-centered medical
home (PCMH) or comparable specialty
practice, as described at
§ 414.1380(b)(3)(ii).
(ii) Beginning in the CY 2025
performance period/2027 MIPS
payment year:
(A) One improvement activity.
(B) Participation in a certified or
recognized patient-centered medical
home (PCMH) or comparable specialty
practice, as described at
§ 414.1380(b)(3)(ii).
*
*
*
*
*
(4) * * *
(i) * * *
(A) An MVP Participant that is a
subgroup is required to submit its
affiliated group’s data for the Promoting
Interoperability performance category.
*
*
*
*
*
(d) * * *
(3) * * *
(i) * * *
(A) Population health measures.
Except as provided in paragraph
(d)(3)(i)(A)(1) of this section, for the CY
2023 through 2024 performance
periods/2025 through 2026 MIPS
payment years, each selected population
health measure that does not have a
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benchmark or meet the case minimum
requirement is excluded from the MVP
participant’s total measure achievement
points and total available measure
achievement points. Beginning in the
CY 2025 performance period/2027 MIPS
payment year, except as provided in
paragraph (d)(3)(i)(A)(1), the highest
score of all applicable and available
population health measures will be
used. If no population health measure
has a benchmark or meet the case
minimum requirement, each such
measure is excluded from the MVP
participant’s total measure achievement
points and total available measure
achievement points.
(1) For the CY 2023 through 2024
performance periods/2025 through 2026
MIPS payment years, a subgroup is
scored on each selected population
health measure based on its affiliated
group score, if available. Beginning in
the CY 2025 performance period/2027
MIPS payment year, a subgroup is
scored on the highest scoring of all
available population health measures
based on its affiliated group score, if
available. If the subgroup’s affiliated
group score is not available, each such
measure is excluded from the
subgroup’s total measure achievement
points and total available measure
achievement points.
*
*
*
*
*
(ii) Cost performance category. The
cost performance category score is
calculated for an MVP Participant using
the methodology at § 414.1380(b)(2) and
the cost measures included in the MVP
that they select and report.
(A) A subgroup is scored on each cost
measure included in the MVP that it
selects and reports based on its affiliated
group score for each such measure, if
available. If the subgroup’s affiliated
group score is not available for a
measure, the measure is excluded from
the subgroup’s total measure
achievement points and total available
measure achievement points, as
described under § 414.1380(b)(2).
*
*
*
*
*
(iii) Improvement activities
performance category. In the CY 2023
through 2024 performance periods/2025
through 2026 MIPS payment years, the
improvement activities performance
category score is calculated based on the
submission of high- and mediumweighted improvement activities. MVP
Participants will receive 20 points for
each medium-weighted improvement
activity and 40 points for each highweighted improvement activity required
under § 414.1360 on which data is
submitted in accordance with
§ 414.1325 or for participation in a
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certified or recognized patient-centered
medical home (PCMH) or comparable
specialty practice, as described at
§ 414.1380(b)(3)(ii). Beginning in the CY
2025 performance period/2027 MIPS
payment year, MVP Participants will
receive 40 points for each improvement
activity required under § 414.1360 on
which data is submitted in accordance
with § 414.1325 or for participation in a
certified or recognized PCMH or
comparable specialty practice, as
described at § 414.1380(b)(3)(ii).
*
*
*
*
*
■ 41. Section 414.1367 is amended by
revising paragraph (c)(1) introductory
text and adding paragraph (c)(1)(iii) to
read as follows:
§ 414.1367
APM performance pathway.
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*
*
*
*
*
(c) * * *
(1) Quality. Except as provided in
paragraphs (c)(1)(i) and (ii) of this
section, the quality performance
category score is calculated for a MIPS
eligible clinician, group, or APM Entity
group in accordance with
§ 414.1380(b)(1) based on the quality
measure set applicable to the MIPS
eligible clinician, group, or APM Entity
group under paragraph (c)(1)(iii) of this
section and established by CMS through
rulemaking for a MIPS payment year.
*
*
*
*
*
(iii)(A) For performance periods
beginning prior to CY 2025 and MIPS
payment years beginning prior to 2027,
a MIPS eligible clinician, group, or APM
Entity group must report the APM
Performance Pathway quality measure
set.
(B) Beginning with the CY 2025
performance period/2027 MIPS
payment year, a MIPS eligible clinician,
group, or APM Entity group may choose
to report either the APM Performance
Pathway quality measure set or the APP
Plus quality measure set.
*
*
*
*
*
■ 42. Section 414.1380 is amended by
—
■ a. Revising paragraph (b)(1)(ii)
introductory text;
■ b. Adding paragraphs (b)(1)(ii)(E) and
(F);
■ c. Revising paragraph (b)(1)(iv)(B);
■ d. Adding paragraph (b)(1)(iv)(C);
■ e. Revising paragraph (b)(1)(vii)
introductory text;
■ f. Adding paragraph (b)(1)(vii)(C);
■ g. Revising paragraph (b)(2)
introductory text;
■ h. Adding paragraphs (b)(2)(i)(A) and
(B) and (b)(2)(v)(B);
■ i. Revising paragraph (b)(3)
introductory text; and
■ j. Adding paragraphs (c)(2)(i)(A)(10)
and (c)(2)(i)(C)(12).
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The revisions and additions read as
follows:
§ 414.1380
Scoring.
*
*
*
*
*
(b) * * *
(1) * * *
(ii) Benchmarks. Except as provided
in paragraphs (b)(1)(ii)(B) through (F) of
this section, benchmarks will be based
on performance by collection type, from
all available sources, including MIPS
eligible clinicians and APMs, to the
extent feasible, during the applicable
baseline or performance period.
*
*
*
*
*
(E) Beginning with the CY 2025
performance period/2027 MIPS
payment year, CMS will publish a list
in the Federal Register of topped out
measures determined to be impacted by
limited measure choice. Measures
included on the list are scored from 1
to 10 measure achievement points
according to defined topped out
measure benchmarks calculated from
performance data in the baseline period
in which a performance rate in the 97th
percentile corresponds to 7.5 measure
achievement points.
(F) Beginning in the CY 2025
performance period/2027 MIPS
payment year, measures of the Medicare
CQM collection type use flat
benchmarks for their first two
performance periods in MIPS.
*
*
*
*
*
(iv) * * *
(B) Beginning with the 2021 MIPS
payment year, except as provided for in
paragraph (b)(1)(iv)(C) of this section,
each measure (except for measures in
the CMS Web Interface) for which the
benchmark for the applicable collection
type is identified as topped out for 2 or
more consecutive years receives no
more than 7 measure achievement
points in the second consecutive year it
is identified as topped out, and beyond.
(C) Beginning with the CY 2025
performance period/2027 MIPS
payment year, measures impacted by
limited measure choice as specified in
paragraph (b)(1)(ii)(E) of this section are
not subject to the 7 measure
achievement point cap specified in
paragraph (b)(1)(iv)(B) of this section.
*
*
*
*
*
(vii) Quality performance category
score. A MIPS eligible clinician’s
quality performance category score is
the sum of all the measure achievement
points assigned for the measures
required for the quality performance
category criteria plus the measure bonus
points in paragraph (b)(1)(v) of this
section and Complex Organization
Adjustment in paragraph (b)(1)(vii)(C) of
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62217
this section. The sum is divided by the
sum of total available measure
achievement points. The improvement
percent score in paragraph (b)(1)(vi) of
this section is added to that result. The
quality performance category score
cannot exceed 100 percentage points.
*
*
*
*
*
(C) Beginning in the CY 2025
performance period/2027 MIPS
payment year, a Virtual Group and an
APM Entity receives one measure
achievement point for each eCQM
submitted that meets the case minimum
requirement at paragraph (b)(1)(iii) of
this section and the data completeness
requirement at § 414.1340. Each
measure may not exceed 10 measure
achievement points. The total
adjustment to the Virtual Group or APM
Entity’s quality performance category
score under this paragraph (b)(1)(vii)(C)
may not exceed 10 percent of the total
available measure achievement points.
(2) Cost performance category. For
each cost measure attributed to a MIPS
eligible clinician, the clinician receives
one to ten achievement points based on
the clinician’s performance on the
measure during the performance period
compared to the measure’s benchmark.
Achievement points are awarded based
on which benchmark range the MIPS
eligible clinician’s performance on the
measure is in. CMS assigns partial
points based on where the MIPS eligible
clinician’s performance falls between
the top and bottom of the benchmark
ranges.
(i) * * *
(A) For the 2019 through 2025 MIPS
payment years, CMS determines cost
measure benchmark ranges based on
linear percentile distributions.
(B) Beginning with the 2026 MIPS
payment year, for each cost measure,
CMS determines 10 benchmark ranges
based on the median cost of all MIPS
eligible clinicians attributed the
measure, plus or minus standard
deviations. CMS awards achievement
points based on which benchmark range
a MIPS eligible clinician’s average cost
for a cost measure corresponds.
Additionally, CMS awards achievement
points equivalent to 10 percent of the
performance threshold for a MIPS
eligible clinician whose average cost
attributed under a cost measure is equal
to the median cost for all MIPS eligible
clinicians attributed the measure.
*
*
*
*
*
(v) * * *
(B) Beginning with the 2027 MIPS
payment year, if data used to calculate
a score for a cost measure are impacted
by significant changes or errors affecting
the performance period, such that
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calculating the cost measure score
would lead to misleading or inaccurate
results, then the affected cost measure is
excluded from the MIPS eligible
clinician’s or group’s cost performance
category score. For purposes of this
paragraph (b)(2)(v)(B), ‘‘significant
changes or errors’’ are changes or errors
external to the care provided, and that
CMS determines may lead to misleading
or inaccurate results that negatively
impact the measure’s ability to reliably
assess performance. Significant changes
or errors include, but are not limited to,
rapid or unprecedented changes to
service utilization, the inadvertent
omission of codes or inclusion of codes,
or changes to clinical guidelines or
measure specifications. CMS will
empirically assess the affected cost
measure to determine the extent to
which the changes or errors impact the
calculation of a cost measure score such
that calculating the cost measure score
would lead to misleading or inaccurate
results that negatively impact the
measure’s ability to reliably assess
performance.
(3) Improvement activities
performance category. Subject to
paragraphs (b)(3)(i) and (ii) of this
section, the improvement activities
performance category score equals the
total points for all submitted
improvement activities divided by 40
points, multiplied by 100 percent. In the
CY 2023 through 2024 performance
periods/2025 through 2026 MIPS
payment years, MIPS eligible clinicians
(except for non-patient facing MIPS
eligible clinicians, small practices, and
practices located in rural areas and
geographic HPSAs) receive 10 points for
each medium-weighted improvement
activity and 20 points for each highweighted improvement activity required
under § 414.1360 on which data is
submitted in accordance with
§ 414.1325. Non-patient facing MIPS
eligible clinicians, small practices, and
practices located in rural areas and
geographic HPSAs receive 20 points for
each medium-weighted improvement
activity and 40 points for each highweighted improvement activity required
under § 414.1360 on which data is
submitted in accordance with
§ 414.1325. Beginning in the CY 2025
performance period/2027 MIPS
payment year, MIPS eligible clinicians
(except for non-patient facing MIPS
eligible clinicians, small practices, and
practices located in rural areas and
geographic HPSAs) receive 20 points for
each improvement activity required
under § 414.1360 on which data is
submitted in accordance with
§ 414.1325. Non-patient facing MIPS
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eligible clinicians, small practices, and
practices located in rural areas and
geographic HPSAs receive 40 points for
each improvement activity required
under § 414.1360 on which data is
submitted in accordance with
§ 414.1325.
*
*
*
*
*
(c) * * *
(2) * * *
(i) * * *
(A) * * *
(10) Beginning with the 2026 MIPS
payment year, for the quality and
improvement activities performance
categories, CMS determines, based on
documentation provided to the agency
on or before November 1st of the year
preceding the relevant MIPS payment
year, that data for a MIPS eligible
clinician are inaccessible or unable to be
submitted due to circumstances outside
of the control of the clinician because
the MIPS eligible clinician delegated
submission of the data to their third
party intermediary, evidenced by a
written agreement between the MIPS
eligible clinician and third party
intermediary, and the third party
intermediary did not submit the data for
the performance category(ies) on behalf
of the MIPS eligible clinician in
accordance with applicable deadlines.
To determine whether to apply
reweighting to the affected performance
category(ies), CMS will consider:
whether the MIPS eligible clinician
knew or had reason to know of the issue
with its third party intermediary’s
submission of the clinician’s data for the
performance category(ies); whether the
MIPS eligible clinician took reasonable
efforts to correct the issue; and whether
the issue between the MIPS eligible
clinician and their third party
intermediary caused no data to be
submitted for the performance
category(ies) in accordance with
applicable deadlines.
*
*
*
*
*
(C) * * *
(12) Beginning with the 2026 MIPS
payment year, CMS determines, based
on documentation provided to the
agency on or before November 1st of the
year preceding the relevant MIPS
payment year, that data for a MIPS
eligible clinician are inaccessible or
unable to be submitted due to
circumstances outside of the control of
the clinician because the MIPS eligible
clinician delegated submission of the
data to their third party intermediary,
evidenced by a written agreement
between the MIPS eligible clinician and
third party intermediary, and the third
party intermediary did not submit the
data for the performance category on
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behalf of the MIPS eligible clinician in
accordance with applicable deadlines.
To determine whether to apply
reweighting to the Promoting
Interoperability performance category,
CMS will consider: whether the MIPS
eligible clinician knew or had reason to
know of the issue with its third party
intermediary’s submission of the
clinician’s data for the performance
category; whether the MIPS eligible
clinician took reasonable efforts to
correct the issue; and whether the issue
between the MIPS eligible clinician and
their third party intermediary caused no
data to be submitted for the performance
category in accordance with applicable
deadlines.
*
*
*
*
*
■ 43. Section 414.1405 is amended by
adding paragraph (b)(10) and revising
paragraph (g) to read as follows:
§ 414.1405
Payment.
*
*
*
*
*
(b) * * *
(10) Pursuant to the methodology
established at paragraph (g)(2) of this
section:
(i) The performance threshold for the
2027 MIPS payment year is 75 points.
The prior period used to determine the
performance threshold is the 2019 MIPS
payment year.
(ii) [Reserved]
*
*
*
*
*
(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)(9) of this
section.
(2) For each of the 2027, 2028, and
2029 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)(10) of this
section.
■ 44. Section 414.1430 is amended by—
■ a. Revising paragraph (a)(1)(v);
■ b. Adding paragraph (a)(1)(vi);
■ c. Revising paragraph (a)(2)(v);
■ d. Adding paragraph (a)(2)(vi);
■ e. Revising paragraph (a)(3)(v);
■ f. Adding paragraph (a)(3)(vi);
■ g. Revising paragraph (a)(4)(v);
■ h. Adding paragraph (a)(4)(vi); and
■ i. Revising paragraphs (b)(1)(i)(A) and
(B), (b)(2)(i)(A) and (B), (b)(3)(i)(A) and
(B), and (b)(4)(i)(A) and (B).
The revisions and additions read as
follows:
§ 414.1430 Qualifying APM participant
determination: QP and partial QP
thresholds.
(a) * * *
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(1) * * *
(v) 2026: 50 percent.
(vi) 2027 and later: 75 percent.
(2) * * *
(v) 2026: 40 percent.
(vi) 2027 and later: 50 percent.
(3) * * *
(v) 2026: 35 percent.
(vi) 2027 and later: 50 percent.
(4) * * *
(v) 2026: 25 percent.
(vi) 2027 and later: 35 percent.
(b) * * *
(1) * * *
(i) * * *
(A) 2021 through 2026: 50 percent.
(B) 2027 and later: 75 percent.
*
*
*
*
*
(2) * * *
(i) * * *
(A) 2021 through 2026: 40 percent.
(B) 2027 and later: 50 percent.
*
*
*
*
*
(3) * * *
(i) * * *
(A) 2021 through 2026: 35 percent.
(B) 2027 and later: 50 percent.
*
*
*
*
*
(4) * * *
(i) * * *
(A) 2021 through 2026: 25 percent.
(B) 2027 and later: 35 percent.
*
*
*
*
*
■ 45. Section 414.1450 is amended by
revising paragraph (a)(1)(i) and the first
sentence of paragraph (b)(1) to read as
follows:
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§ 414.1450
APM incentive payment.
(a) * * *
(1) * * *
(i) For payment years 2019 through
2026, 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.
*
*
*
*
*
(b) * * *
(1) For payment years 2019 through
2024, the amount of the APM Incentive
Payment is equal to 5 percent, with
respect to payment year 2025, 3.5
percent, or with respect to payment year
2026, 1.88 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. * * *
*
*
*
*
*
PART 423—VOLUNTARY MEDICARE
PRESCRIPTION DRUG BENEFIT
46. The authority citation for part 423
continues to read as follows:
■
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Authority: 42 U.S.C. 1302, 1306, 1395w–
101 through 1395w–152, and 1395hh.
47. Section 423.160 is amended by
revising paragraph (a)(5) introductory
text to read as follows:
■
§ 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, 2028. 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, 2028. 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:
*
*
*
*
*
PART 424—CONDITIONS FOR
MEDICARE PAYMENT
48. The authority citation for part 424
continues to read as follows:
■
Authority: 42 U.S.C. 1302 and 1395hh.
49. Section 424.24 is amended by
revising paragraphs (c) heading, (c)(1)(i),
and (c)(3)(ii) and adding paragraph
(c)(5) to read as follows:
■
§ 424.24 Requirements for medical and
other health services furnished by
providers under Medicare Part B.
*
*
*
*
*
(c) Outpatient physical therapy,
occupational therapy, and speechlanguage pathology services—
(1) * * *
(i) The individual needs, or needed,
physical therapy, occupational therapy,
or speech-language pathology services.
*
*
*
*
*
(3) * * *
(ii) If the plan of treatment is
established by a physical therapist,
occupational therapist, or speechlanguage pathologist, the certification
must be signed by a physician or by a
nurse practitioner, clinical nurse
specialist, or physician assistant who
has knowledge of the case, except as
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specified in paragraph (c)(5) of this
section.
*
*
*
*
*
(5) Treatment plan. If the plan of
treatment is established by a physical
therapist, occupational therapist, or
speech-language pathologist, and there
is a written order or referral from the
individual’s physician, nurse
practitioner (NP), physician assistant
(PA), or clinical nurse specialist (CNS)
in the patient’s record and the therapist
has documented evidence that the plan
of care has been delivered to the
physician, NP, PA, or CNS within 30
days of completion of the initial
evaluation, the certification does not
need to be signed by a physician, NP,
CNS, or PA who has knowledge of the
case. If there is no written order or
referral from the individual’s physician,
NP, CNS, or PA, in the patient’s record,
the therapist must obtain the signature
of the physician, NP, PA, or CNS on the
plan of treatment in accordance with
paragraph (c)(3) of this section. No
references to an order or referral in this
subsection shall be construed to require
an order or referral for outpatient
physical therapy, occupational therapy,
or speech-language pathology services.
*
*
*
*
*
■ 50. Section 424.205 is amended by
revising paragraphs (c)(10), (f)(1)(ii),
(f)(2)(i), and (f)(5) to read as follows:
§ 424.205 Requirements for Medicare
Diabetes Prevention Program suppliers.
*
*
*
*
*
(c) * * *
(10) Except as allowed under
paragraph (d)(8) of this section, the
MDPP supplier must offer an MDPP
beneficiary no fewer than all of the
following:
(i) 16 in-person or distance learning
core sessions no more frequently than
weekly for the first 6 months of the
MDPP services period, which begins on
the date of attendance at the first such
core session.
(ii) 1 in-person or distance learning
core maintenance session each month
during months 7 through 12 (6 months
total) of the MDPP services period.
*
*
*
*
*
(f) * * *
(1) * * *
(ii) Basic beneficiary information for
each MDPP beneficiary in attendance,
including but not limited to beneficiary
name, Medicare Beneficiary Identifier
(MBI), and age.
*
*
*
*
*
(2) * * *
(i) Documentation of the type of
session (in-person or distance learning).
*
*
*
*
*
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(5) The MDPP supplier’s records must
include an attestation from the MDPP
supplier that, as applicable, the MDPP
beneficiary for which it is submitting a
claim—
(i) Has achieved the required
minimum 5-percent weight loss as
measured in accordance with
§ 410.79(e)(3)(iii) of this chapter during
a core session or core maintenance
session furnished by that supplier, if the
claim submitted is for a performance
payment under § 414.84(b)(1) of this
chapter.
(ii) Has achieved the required
minimum 5-percent weight loss as
measured in-person during a core
session or core maintenance session
furnished by that supplier, if the claim
submitted is for a performance payment
under § 414.84(b)(1) of this chapter.
(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
that supplier, if the claim submitted is
for a performance payment under
§ 414.84(b)(2) of this chapter.
(iv) Has achieved at least a 9-percent
weight loss percentage as measured inperson during a core session or core
maintenance session furnished by that
supplier, if the claim submitted is for a
performance payment under
§ 414.84(b)(2) of this chapter.
*
*
*
*
*
PART 425—MEDICARE SHARED
SAVINGS PROGRAM
51. The authority citation for part 425
continues to read as follows:
■
Authority: 42 U.S.C. 1302, 1306, 1395hh,
and 1395jjj.
52. Section 425.100 is amended by
adding paragraph (e) to read as follows:
■
§ 425.100
General.
*
*
*
*
*
(e) An ACO is eligible to receive
prepaid shared savings if it meets the
criteria under § 425.640(b).
■ 53. Section 425.110 is amended by
revising paragraph (b)(2) to read as
follows:
§ 425.110 Number of ACO professionals
and beneficiaries.
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*
*
*
*
*
(b) * * *
(2) For performance years starting
before January 1, 2025, if the ACO’s
assigned population is not at least 5,000
by the end of the performance year
specified by CMS in its request for a
corrective action plan (CAP), CMS
terminates the participation agreement
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and the ACO is not eligible to share in
savings for that performance year.
*
*
*
*
*
■ 54. Section 425.202 is amended by
revising paragraph (a)(3) to read as
follows:
§ 425.202
Application procedures.
(a) * * *
(3) An ACO that seeks to participate
in the Shared Savings Program must
agree that CMS can share a copy of their
application with the Antitrust Agencies.
*
*
*
*
*
■ 55. Section 425.204 is amended by—
■ a. Revising paragraphs (f)(1) and (f)(3)
introductory text;
■ b. In paragraphs (f)(3)(iv), (f)(4)(iv)(A),
and (f)(6)(ii) introductory text, removing
the phrase ‘‘any shared losses incurred’’
and adding in its place the phrase ‘‘any
shared losses incurred and prepaid
shared savings determined to be owed’’;
■ c. In paragraphs (f)(5) and (f)(6)(iv)(A),
removing the phrase ‘‘shared losses
owed’’ and adding in its place the
phrase ‘‘shared losses owed or prepaid
shared savings determined to be owed’’;
■ d. In paragraph (f)(6)(iii), removing
the phrase ‘‘shared losses’’ and adding
in its place the phrase ‘‘shared losses or
prepaid shared savings determined to be
owed’’; and
■ e. In paragraph (f)(6)(iv)(C), removing
the phrase ‘‘owe any shared losses’’ and
adding in its place the phrase ‘‘owe any
shared losses or prepaid shared
savings’’.
The revisions read as follows:
§ 425.204
Content of the application.
*
*
*
*
*
(f) * * *
(1) An ACO must have the ability to
repay all shared losses for which it may
be liable under a two-sided model and
any prepaid shared savings determined
to be owed.
*
*
*
*
*
(3) An ACO that will participate
under a two-sided model of the Shared
Savings Program must submit for CMS
approval documentation that it is
capable of repaying shared losses that it
may incur during its agreement period,
including details supporting the
adequacy of the repayment mechanism.
If the ACO will receive prepaid shared
savings, the repayment mechanism must
also support repayment of prepaid
shared savings in accordance with
§ 425.640.
*
*
*
*
*
■ 56. Section 425.224 is amended by
revising paragraph (a)(3) to read as
follows:
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§ 425.224 Application procedures for
renewing ACOs and re-entering ACOs.
(a) * * *
(3) An ACO that seeks to enter a new
participation agreement under the
Shared Savings Program must agree that
CMS can share a copy of its application
with the Antitrust Agencies.
*
*
*
*
*
■ 57. Section 425.304 is amended by
adding paragraph (d) to read as follows:
§ 425.304
Beneficiary incentives.
*
*
*
*
*
(d) Application of the CMS-sponsored
model patient incentives safe harbor.
CMS has determined that the Federal
anti-kickback statute safe harbor for
CMS-sponsored model patient
incentives (§ 1001.952(ii)(2) of this title)
is available to protect remuneration
furnished in the prepaid shared savings
option of the Shared Savings Program in
the form of direct beneficiary services
that meets all safe harbor requirements
set forth in § 1001.952(ii) of this title.
■ 58. Section 425.308 is amended by
adding paragraph (b)(10) to read as
follows:
§ 425.308 Public reporting and
transparency.
*
*
*
*
*
(b) * * *
(10) Information updated annually
about the ACO’s use of prepaid shared
savings under § 425.640, for each
performance year, including the
following:
(i) Total amount of any prepaid
shared savings received from CMS.
(ii) The ACO’s spend plan.
(iii) An itemization of how prepaid
shared savings were spent during the
year, including expenditure categories,
the dollar amounts spent on the various
categories, information about which
groups of beneficiaries received direct
beneficiary services that were purchased
with prepaid shared savings and
investments that were made in the ACO
with prepaid shared savings, how these
direct beneficiary services were
provided to beneficiaries and how the
direct beneficiary services and
investments supported the care of
beneficiaries, any changes to the spend
plan as submitted under § 425.640(d)(2)
(if applicable), and such other
information as may be specified by
CMS.
*
*
*
*
*
■ 59. Section 425.312 is amended by
revising paragraphs (a)(2)(iii) and
(a)(2)(v)(A) to read as follows:
§ 425.312
Beneficiary notifications.
(a) * * *
(2) * * *
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(iii) In the case of an ACO that has
selected preliminary prospective
assignment with retrospective
reconciliation, by the ACO or ACO
participant providing each beneficiary
who received at least one primary care
service during the assignment window
or applicable expanded window for
assignment (as defined in § 425.20) from
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), a
FQHC or RHC that is part of the ACO,
or an ACO professional in the ACO
whom the beneficiary designated as
responsible for coordinating their
overall care under § 425.402(e) with a
standardized written notice at least once
during an agreement period in the form
and manner specified by CMS. The
standardized written notice must be
furnished to all of these beneficiaries
prior to or at the first primary care
service visit during the first
performance year in which the
beneficiary receives a primary care
service from an ACO participant.
*
*
*
*
*
(v) * * *
(A) The follow-up communication
must occur no later than 180 days from
the date the standardized written notice
was provided.
*
*
*
*
*
■ 60. Section 425.315 is amended by
revising paragraph (a)(4) and adding
paragraph (b) to read as follows:
§ 425.315 Reopening determinations of
ACO shared savings or shared losses to
correct financial reconciliation calculations.
(a) * * *
(4) CMS has the sole discretion to
determine whether to reopen a payment
determination under this section.
(b) Reopening requests. An ACO may
request a reopening in a form and
manner specified by CMS and
consistent with the timeframes for a
reopening specified in paragraphs
(a)(1)(i) and (ii) of this section.
■ 61. Section 425.316 is amended by
adding paragraph (f) to read as follows:
§ 425.316
Monitoring of ACOs.
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*
*
*
*
*
(f) Monitoring ACO eligibility for and
use of prepaid shared savings. (1) CMS
monitors an ACO that receives prepaid
shared savings pursuant to § 425.640 to
ensure ACO compliance with
§ 425.640(e) and to determine whether it
would be appropriate to withhold or
terminate an ACO’s prepaid shared
savings under § 425.640(h).
(2) If CMS determines that an ACO
receiving prepaid shared savings is
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using the funds for a prohibited use
under § 425.640(e)(2), fails to spend the
funding in accordance with
§ 425.640(e)(1)(i) and (ii), or spends
more than 50 percent of the estimated
annual payment amount on staffing and
healthcare infrastructure CMS:
(i) Will require the ACO to reallocate
the funding as permitted by § 425.640(e)
and submit an updated spend plan
demonstrating the reallocation by a
deadline specified by CMS.
(ii) May take compliance action as
specified in §§ 425.216, 425.218, and
425.640(h)(1).
(3) If an ACO fails to reallocate
prepaid shared savings it received as
described in paragraph (f)(2)(i) of this
section by a deadline specified by CMS,
the ACO must repay all prepaid shared
savings it received and may be subject
to compliance action as specified in
§§ 425.216 and 425.218. 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.
■ 62. Section 425.400 is amended by
revising paragraph (c)(1)(viii)
introductory text and adding paragraph
(c)(1)(ix) to read as follows:
§ 425.400
General.
*
*
*
*
*
(c) * * *
(1) * * *
(viii) For the performance year
starting on January 1, 2024, as follows:
*
*
*
*
*
(ix) For the performance year starting
on January 1, 2025, 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) 97550, 97551, and 97552 (codes
for caregiver training services).
(4) 99201 through 99215 (codes for
office or other outpatient visit for the
evaluation and management of a
patient).
(5) 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 skilled
nursing facility (SNF)).
(6) 99319 through 99340 (codes for
patient domiciliary, rest home, or
custodial care visit).
(7) 99341 through 99350 (codes for
evaluation and management services
furnished in a patient’s home).
(8) 99354 and 99355 (add-on codes,
for prolonged evaluation and
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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)(ix)).
(9) 99406 and 99407 (codes for
smoking and tobacco-use cessation
counseling services).
(10) 99421, 99422, and 99423 (codes
for online digital evaluation and
management).
(11) 99424, 99425, 99426, and 99427
(codes for principal care management
services).
(12) 99437, 99487, 99489, 99490 and
99491 (codes for chronic care
management).
(13) 99439 (code for non-complex
chronic care management).
(14) 99446, 99447, 99448, 99449,
99451, 99452 (codes for
interprofessional consultation services).
(15) 99483 (code for assessment of
and care planning for patients with
cognitive impairment).
(16) 99484, 99492, 99493 and 99494
(codes for behavioral health integration
services).
(17) 99495 and 99496 (codes for
transitional care management services).
(18) 99497 and 99498 (codes for
advance care planning; services
identified by these codes furnished in
an inpatient setting are excluded).
(19) 9X091 (code for virtual check-in).
(B) HCPCS codes:
(1) G0019 and G0022 (codes for
community health integration services).
(2) G0023 and G0024 (codes for
principal illness navigation services).
(3) G0101 (code for cervical or vaginal
cancer screening).
(4) G0136 (code for social
determinants of health risk assessment
services).
(5) G0317, G0318, and G2212 (codes
for prolonged office or other outpatient
visit for the evaluation and management
of a patient).
(6) G0402 (code for the Welcome to
Medicare visit).
(7) G0438 and G0439 (codes for the
annual wellness visits).
(8) G0442 (code for alcohol misuse
screening service).
(9) G0443 (code for alcohol misuse
counseling service).
(10) G0444 (code for annual
depression screening service).
(11) G0463 (code for services
furnished in electing teaching
amendment (ETA) hospitals).
(12) G0506 (code for chronic care
management).
(13) G2010 (code for the remote
evaluation of patient video/images).
(14) G2012 and G2252 (codes for
virtual check-in).
(15) G2058 (code for non-complex
chronic care management).
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(16) G2064 and G2065 (codes for
principal care management services).
(17) G2086, G2087, and G2088 (codes
for office-based opioid use disorder
services).
(18) G2211 (code for visit complexity
inherent to evaluation and management
services add-on).
(19) G2214 (code for psychiatric
collaborative care model).
(20) G3002 and G3003 (codes for
chronic pain management).
(21) GCDRA and GCDRM (codes for
cardiovascular risk assessment and risk
management services).
(22) GCTB1 and GCTB2 (codes for
individual behavior management/
modification caregiver training
services).
(23) GCTD1, GCTD2, and GCTD3
(codes for direct care caregiver training
services).
(24) GFCI1 (code for post-discharge
telephonic follow-up contacts
intervention).
(25) GPCM1, GPCM2, and GPCM3
(codes for advanced primary care
management services).
(26) GSPI1 (code for safety planning
interventions when the base code is also
a primary care service code under this
paragraph (c)(1)(ix)).
(C) Primary care service codes include
any CPT code identified by CMS that
directly replaces a CPT code specified
in paragraph (c)(1)(ix)(A) of this section
or a HCPCS code specified in paragraph
(c)(1)(ix)(B) of this section, when the
assignment window or expanded
window for assignment (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.
*
*
*
*
*
■ 63. Section 425.402 is amended by
revising paragraph (e)(2)(ii) introductory
text and adding paragraph (e)(2)(iii) to
read as follows:
§ 425.402
Basic assignment methodology.
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*
*
*
*
*
(e) * * *
(2) * * *
(ii) For performance years starting on
January 1, 2019, through 2024:
*
*
*
*
*
(iii) For performance year 2025 and
subsequent performance years:
(A) The beneficiary meets the
eligibility criteria established at
§ 425.401(a) and must not be excluded
by the criteria at § 425.401(b). 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
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an ACO professional as responsible for
coordinating their overall care under
paragraph (e) of this section, regardless
of the ACO’s assignment methodology
selection under § 425.226(a)(1).
(B) The beneficiary must have
designated an ACO professional as
responsible for coordinating their
overall care.
(C) If a beneficiary has designated a
provider or supplier outside the ACO as
responsible for coordinating their
overall care, the beneficiary is not added
under the assignment methodology in
paragraph (b) of this section to the
ACO’s list of assigned beneficiaries for
a 12-month performance year.
(D) The beneficiary is not assigned to
an entity participating in a model tested
or expanded under section 1115A of the
Act under which claims-based
assignment is based solely on:
(1) Claims for primary care and/or
other services related to treatment of
one or more specific diseases or
conditions targeted by the model; or
(2) Claims for services other than
primary care services, and for which
there has been a determination by the
Secretary that waiver of the requirement
in section 1899(c)(2)(B) of the Act is
necessary solely for purposes of testing
the model.
*
*
*
*
*
■ 64. Section 425.508 is amended by
revising paragraph (b) and adding
paragraph (c) to read as follows:
§ 425.508 Incorporating quality reporting
requirements related to the Quality Payment
Program.
*
*
*
*
*
(b) For performance years beginning
in 2021–2024. ACOs must submit the
quality data via the APM Performance
Pathway (APP) established under
§ 414.1367 of this chapter to
satisfactorily report on behalf of the
eligible clinicians who bill under the
TIN of an ACO participant for purposes
of the MIPS Quality performance
category of the Quality Payment
Program.
(c) For performance years beginning
on or after January 1, 2025. ACOs must
submit the quality data via the APM
Performance Pathway (APP) on the
quality measures contained in the APP
Plus quality measure set established
under § 414.1367 of this chapter to
satisfactorily report on behalf of the
eligible clinicians who bill under the
TIN of an ACO participant for purposes
of the MIPS Quality performance
category of the Quality Payment
Program.
■ 65. Section 425.510 is amended by
revising the section heading and
paragraph (b) to read as follows:
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§ 425.510 Application of the APM
Performance Pathway (APP) quality
measure set or the APP Plus quality
measure set (as applicable) to Shared
Savings Program ACOs for performance
years beginning on or after January 1, 2021.
*
*
*
*
*
(b) Quality reporting. (1) For
performance years beginning in 2021–
2024, ACOs must report quality data on
the APP quality measure set established
under § 414.1367 of this chapter,
according to the method of submission
established by CMS.
(2) For performance years beginning
on or after January 1, 2025, ACOs must
report quality data on the APP Plus
quality measure set established under
§ 414.1367 of this chapter, according to
the method of submission established
by CMS.
*
*
*
*
*
■ 66. Section 425.512 is amended by—
■ a. Revising paragraphs (a)(2)(iii),
(a)(5)(i) introductory text, (a)(5)(i)(A)
introductory text, (a)(5)(i)(B), (a)(5)(ii),
(a)(5)(iii)(B), and (a)(7);
■ b. Revising and republishing
paragraph (b);
■ c. In paragraph (c)(3) introductory
text, removing the phrase ‘‘via the APP’’
and adding in its place the phrase ‘‘on
the APP quality measure set or the APP
Plus quality measure set (as
applicable)’’;
■ d. In paragraph (c)(3)(iii), removing
the phrase ‘‘and subsequent
performance years’’ after ‘‘For
performance year 2024’’; and
■ e. Adding paragraph (c)(3)(iv).
The revisions, republication, and
addition read as follows:
§ 425.512 Determining the ACO quality
performance standard for performance
years beginning on or after January 1, 2021.
(a) * * *
(2) * * *
(iii) For performance year 2025 and
subsequent performance years, if the
ACO reports the APP Plus quality
measure set and meets the data
completeness requirement at § 414.1340
of this subchapter on all eCQMs/
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) Except as specified in paragraphs
(a)(2) and (7) of this section, CMS
designates the quality performance
standard as:
(A) For performance year 2024, the
ACO reporting quality data on the APP
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quality measure set established under
§ 414.1367 of this subchapter, according
to the method of submission established
by CMS and—
*
*
*
*
*
(B) For performance year 2025 and
subsequent performance years, the ACO
reporting quality data on the APP Plus
quality measure set established under
§ 414.1367 of this subchapter, according
to the method of submission established
by CMS and—
(1) Achieving 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 facilitybased scoring; or
(2) If the ACO reports all of the
eCQMs in the APP Plus quality measure
set applicable for a performance year,
meeting the data completeness
requirement at § 414.1340 of this
subchapter for all eCQMs, and achieving
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 Plus quality 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 measures in the APP
Plus quality measure set.
(ii) CMS designates an alternative
quality performance standard for an
ACO that does not meet the criteria
described in paragraph (a)(2) or (a)(5)(i)
of this section as the following:
(A) For performance year 2024, the
ACO reports quality data on the APP
quality measure set established under
§ 414.1367 of this subchapter according
to the method of submission established
by CMS and 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 quality measure set.
(B) For performance year 2025 and
subsequent performance years, the ACO
reports quality data on the APP Plus
quality measure set established under
§ 414.1367 of this subchapter according
to the method of submission established
by CMS and 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 Plus quality measure set.
(iii) * * *
(B) For performance year 2025 and
subsequent performance years, the ACO
does not report any of the eCQMs/
Medicare CQMs in the APP Plus quality
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measure set and does not administer a
CAHPS for MIPS survey (except as
specified in § 414.1380(b)(1)(vii)(B) of
this subchapter).
*
*
*
*
*
(7) Facility-based scoring. 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 when—
(i) For performance year 2024, if an
ACO reports all of the required
measures, meeting the data
completeness requirement at § 414.1340
of this subchapter for each measure in
the APP quality measure set and
receiving a MIPS Quality performance
category score as described at
§ 414.1380(b)(1) of this subchapter and
the ACO meets either of the following:
(A) The ACO’s total available measure
achievement points used to calculate
the ACO’s MIPS Quality performance
category score are reduced under
§ 414.1380(b)(1)(vii)(A) of this
subchapter.
(B) At least one of the eCQMs/MIPS
CQMs/Medicare CQMs does not have a
benchmark as described at
§ 414.1380(b)(1)(i)(A) of this subchapter.
(ii) For performance year 2025 and
subsequent performance years, if an
ACO reports all of the required
measures in the APP Plus quality
measure set, meeting the data
completeness requirement at § 414.1340
of this subchapter for each measure in
the APP Plus quality measure set, and
receiving a MIPS Quality performance
category score as described at
§ 414.1380(b)(1) of this subchapter, for
the relevant performance year, and the
ACO meets either of the following:
(A) The ACO’s total available measure
achievement points used to calculate
the ACO’s MIPS Quality performance
category score are reduced under
§ 414.1380(b)(1)(vii)(A) of this
subchapter.
(B) At least one of the eCQMs/
Medicare CQMs does not have a
benchmark as described at
§ 414.1380(b)(1)(i)(A) of this subchapter.
(b) Calculation of ACO’s health equity
adjusted quality performance score for
performance year 2023 and subsequent
performance years—(1) For performance
year 2023. For an ACO that reports the
three eCQMs/MIPS CQMs in the APP
quality measure set, meeting the data
completeness requirement at § 414.1340
of this subchapter for all three eCQMs/
MIPS CQMs, and administers the
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62223
CAHPS for MIPS survey, 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 quality measure set
and the ACO’s health equity adjustment
bonus points calculated in accordance
with paragraph (b)(4) of this section.
The sum of these values may not exceed
100 percent.
(2) For performance year 2024. For an
ACO that reports the three eCQMs/MIPS
CQMs/Medicare CQMs in the APP
quality measure set, meeting the data
completeness requirement at § 414.1340
of this subchapter 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
subchapter), 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 quality measure set and the ACO’s
health equity adjustment bonus points
calculated in accordance with paragraph
(b)(4) of this section. The sum of these
values may not exceed 100 percent.
(3) For performance year 2025 and
subsequent performance years. For an
ACO that reports all of the eCQMs/
Medicare CQMs in the APP Plus quality
measure set, meeting the data
completeness requirement at § 414.1340
of this subchapter for all of the eCQMs/
Medicare CQMs, and administers the
CAHPS for MIPS survey (except as
specified in § 414.1380(b)(1)(vii)(B) of
this subchapter), 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 Plus quality measure set and the
ACO’s health equity adjustment bonus
points calculated in accordance with
paragraph (b)(4) of this section. The sum
of these values may not exceed 100
percent.
(4) Calculation of ACO’s health equity
adjustment bonus points. CMS
calculates the ACO’s health equity
adjustment bonus points as follows:
(i) For each measure in the APP
quality measure set, CMS groups an
ACO’s performance into the top,
middle, or bottom third of ACO measure
performers by reporting mechanism.
(ii) CMS assigns values to the ACO for
its performance on each measure as
follows:
(A) Values of four, two, or zero for
each measure for which the ACO’s
performance places it in the top,
middle, or bottom third of ACO measure
performers, respectively.
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(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.
(iii) CMS sums the values assigned to
the ACO according to paragraph
(b)(4)(ii) of this section, to calculate the
ACO’s measure performance scaler.
(iv) CMS calculates an underserved
multiplier for the ACO.
(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)(4)(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.
(B) If the proportion determined in
accordance with paragraph (b)(4)(iv)(A)
of this section is lower than 20 percent,
the ACO is ineligible for health equity
adjustment bonus points.
(v) Except as specified in paragraph
(b)(4)(iv)(B) of this section, CMS
calculates the ACO’s health equity
adjustment bonus points as the product
of the measure performance scaler
determined under paragraph (b)(4)(iii)
of this section and the underserved
multiplier determined under paragraph
(b)(4)(iv) of this section. If the product
of these values is greater than 10, the
value of the ACO’s health equity
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adjustment bonus points is set equal to
10.
(5) Use of ACO’s health equity
adjusted quality performance score. The
ACO’s health equity adjusted quality
performance score, determined in
accordance with paragraphs (b)(1)
through (4) of this section, is used as
follows:
(i) In determining whether the ACO
meets the quality performance standard
as specified under paragraphs
(a)(4)(i)(A), (a)(5)(i)(A)(1), (a)(5)(i)(B),
and (a)(7) of this section.
(ii) In determining the final sharing
rate for calculating shared savings
payments under the BASIC track in
accordance with § 425.605(d), and
under the ENHANCED track in
accordance with § 425.610(d), for an
ACO that meets the alternative quality
performance standard by meeting the
criteria specified in paragraph (a)(4)(ii)
or (a)(5)(ii) of this section.
(iii) In determining the shared loss
rate for calculating shared losses under
the ENHANCED track in accordance
with § 425.610(f), for an ACO that meets
the quality performance standard
established in paragraphs (a)(2), (a)(4)(i),
and (a)(5)(i) of this section or the
alternative quality performance
standard established in paragraph
(a)(4)(ii) or (a)(5)(ii) of this section.
(iv) In determining the quality
performance score for an ACO affected
by extreme and uncontrollable
circumstances as described in
paragraphs (c)(3)(ii) through (iv) of this
section.
(c) * * *
(3) * * *
(iv) For performance year 2025 and
subsequent performance years, if the
ACO reports the APP Plus quality
measure set and meets the data
completeness requirement at § 414.1340
of this subchapter and receives a MIPS
Quality performance category score
under § 414.1380(b)(1) of this
subchapter, 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.
*
*
*
*
*
■ 67. Section 425.601 is amended by
revising paragraph (a)(9) introductory
text and adding paragraphs (a)(9)(iii)
and (iv) to read as follows:
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§ 425.601 Establishing, adjusting, and
updating the benchmark for agreement
periods beginning on or after July 1, 2019,
and before January 1, 2024.
(a) * * *
(9) 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 changes in values used in
benchmark calculations as a result of
issuance of a revised initial
determination under § 425.315, and for
changes in values used in benchmark
calculations as a result of the
performance year being affected by
significant, anomalous, and highly
suspect billing under § 425.672. To
adjust the benchmark, CMS does the
following:
*
*
*
*
*
(iii) Recalculates benchmark year
expenditures to account for the impact
of improper payments, for the
benchmark year corresponding to a
performance year for which CMS issued
a revised initial determination under
§ 425.315. In recalculating expenditures
for the benchmark year, CMS applies
the calculation methodology applied in
recalculating expenditures for the
corresponding performance year in
accordance with § 425.674.
(iv) Recalculates expenditures used in
Shared Savings Program benchmark
calculations under this section, to
exclude the same HCPCS or CPT codes
identified as displaying significant,
anomalous, and highly suspect billing
patterns in calculation of performance
year expenditures, in accordance with
§ 425.672.
*
*
*
*
*
■ 68. Section 425.605 is amended by
revising paragraph (a)(1)(ii)(C) to read as
follows:
§ 425.605 Calculation of shared savings
and losses under the BASIC track.
(a) * * *
(1) * * *
(ii) * * *
(C) The aggregate growth in
demographic risk scores for purposes of
paragraph (a)(1)(ii)(A) of this section
and the aggregate growth in prospective
hierarchical condition category (HCC)
risk scores for purposes of paragraph
(a)(1)(ii)(B) of this section is calculated
by taking a weighted average of the
growth in demographic risk scores or
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prospective HCC risk scores, as
applicable, across the populations
described in paragraph (a)(2) of this
section. When calculating the weighted
average growth in demographic risk
scores or prospective HCC risk scores, as
applicable, the weight applied to the
growth in risk scores (expressed as a
ratio of the ACO’s performance year risk
score to the ACO’s BY3 risk score) for
each Medicare enrollment type is equal
to the product of the ACO’s historical
benchmark expenditures, adjusted in
accordance with § 425.652(a)(8), for that
enrollment type and the ACO’s
performance year assigned beneficiary
person years for that enrollment type.
*
*
*
*
*
■ 69. Section 425.610 is amended by
revising paragraph (a)(2)(ii)(C) to read as
follows:
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§ 425.610 Calculation of shared savings
and losses under the ENHANCED track.
(a) * * *
(2) * * *
(ii) * * *
(C) The aggregate growth in
demographic risk scores for purposes of
paragraph (a)(2)(ii)(A) of this section
and the aggregate growth in prospective
HCC risk scores for purposes of
paragraph (a)(2)(ii)(B) of this section is
calculated by taking a weighted average
of the growth in demographic risk
scores or prospective HCC risk scores, as
applicable, across the populations
described in paragraph (a)(3) of this
section. When calculating the weighted
average growth in demographic risk
scores or prospective HCC risk scores, as
applicable, the weight applied to the
growth in risk scores (expressed as a
ratio of the ACO’s performance year risk
score to the ACO’s BY3 risk score) for
each Medicare enrollment type is equal
to the product of the ACO’s historical
benchmark expenditures, adjusted in
accordance with § 425.652(a)(8), for that
enrollment type and the ACO’s
performance year assigned beneficiary
person years for that enrollment type.
*
*
*
*
*
■ 70. Section 425.630 is amended by—
■ a. In paragraph (g)(3), removing the
phrase ‘‘paragraphs (g)(4) of this
section’’ and adding in its place the
phrase ‘‘paragraphs (g)(4) through (6) of
this section’’;
■ b. Redesignating paragraph (g)(5) as
paragraph (g)(7);
■ c. Adding new paragraph (g)(5) and
paragraph (g)(6);
■ d. In paragraph (h)(1)(ii), removing
‘‘or’’ at the end of the paragraph;
■ e. In paragraph (h)(1)(iii), removing
the period at the end of paragraph and
adding ‘‘; or’’ in its place; and
■ f. Adding paragraph (h)(1)(iv).
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The additions read as follows:
§ 425.630 Option to receive advance
investment payments.
*
*
*
*
*
(g) * * *
(5) If an ACO notifies CMS that it no
longer wants to participate in the
advance investment payment option but
does want to continue its participation
in the Shared Savings Program, the ACO
must repay all outstanding advance
investment payments it received. CMS
will provide written notice 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.
(6) If CMS terminates the
participation agreement of an ACO that
has an outstanding balance of advance
investment payments owed to CMS, the
ACO must repay any outstanding
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.
*
*
*
*
*
(h) * * *
(1) * * *
(iv) Voluntarily terminates payments
of advance investment payments but
continues its participation in the Shared
Savings Program.
*
*
*
*
*
■ 71. Section 425.640 is added to read
as follows:
§ 425.640
savings.
Option to receive prepaid shared
(a) Purpose. Prepaid shared savings
provide an additional cash flow option
to ACOs with a history of earning
shared savings that will encourage their
investment in activities that reduce
costs for the Medicare program and
beneficiaries and improve the quality of
care provided to their assigned
beneficiaries.
(b) Eligibility. An ACO is eligible to
receive prepaid shared savings in an
agreement period as specified in this
section if CMS determines that all of the
following criteria are met:
(1) The ACO is a renewing ACO as
defined under § 425.20 entering an
agreement period beginning on January
1, 2026, or in subsequent years.
(2) The ACO must have received a
shared savings payment for the most
recent performance year that:
(i) Occurred prior to the agreement
period for which the ACO has applied
to receive prepaid shared savings; and
(ii) CMS has conducted financial
reconciliation.
(3) The ACO must have a positive
prior savings adjustment for the
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agreement period for which the ACO
has applied to receive prepaid shared
savings as calculated pursuant to
§ 425.658.
(4) The ACO does not have any
outstanding shared losses or advance
investment payments that have not yet
been repaid to CMS after reconciliation
for the most recent performance year for
which CMS completed financial
reconciliation.
(5) If the ACO received prepaid
shared savings in the current agreement
period or a prior agreement period, the
ACO must have fully repaid the amount
of prepaid shared savings received
through the most recent performance
year for which CMS has completed
financial reconciliation.
(6) The ACO is participating in Levels
C through E of the BASIC track or the
ENHANCED track during the agreement
period in which it would receive
prepaid shared savings.
(7) The ACO has in place an adequate
repayment mechanism in accordance
with § 425.204(f) that can be used to
recoup outstanding prepaid shared
savings.
(8) During the agreement period
immediately preceding the agreement
period in which the ACO would receive
prepaid shared savings, the ACO:
(i) Met the quality performance
standard as specified under § 425.512;
and
(ii) Has not been determined by CMS
to have avoided at-risk beneficiaries as
specified under § 425.316(b)(2).
(c) Application procedure. To obtain
a determination regarding whether an
ACO may receive prepaid shared
savings, the ACO must submit to CMS
a complete supplemental application
with its application to renew for a new
agreement period in the Shared Savings
Program (submitted pursuant to
§ 425.202) in the form and manner and
by a deadline specified by CMS.
(d) Application contents and review—
(1) General. An ACO must submit to
CMS supplemental application
information sufficient for CMS to
determine whether the ACO is eligible
to receive prepaid shared savings. In
addition, the ACO must submit a
proposed spend plan as part of the
supplemental application information.
(2) Spend plan. The ACO’s spend
plan must:
(i) Describe how an ACO receiving
prepaid shared savings will spend the
payments during the first performance
year in which it will receive prepaid
shared savings. The spend plan must be
updated annually for each performance
year of the agreement period during
which the ACO receives prepaid shared
savings.
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(ii) Identify the categories of items
and services that will be purchased and
investments that will be made in the
ACO with prepaid shared savings
(consistent with the allowable uses
under paragraph (e) of this section), the
dollar amounts to be spent on such
categories, information about which
groups of beneficiaries the ACO expects
to receive direct beneficiary services
that will be purchased with prepaid
shared savings, how direct beneficiary
services will be distributed to
beneficiaries and how such services
support the care of beneficiaries,
descriptions of the investments that will
be made in the ACO with prepaid
shared savings, and such other
information as may be specified by
CMS.
(iii) Include an attestation that the
ACO will not discriminate on the basis
of race, color, religion, sex, national
origin, disability, or age with respect to
their use of prepaid shared savings.
(iv) Include the ACO’s
communication strategy for notifying
CMS and any impacted beneficiaries if
an ACO will no longer be providing any
direct beneficiary services that had
previously been provided by the ACO
using prepaid shared savings.
(3) CMS review. CMS will review the
supplemental application information to
determine whether an ACO meets the
eligibility criteria and other
requirements necessary to receive
prepaid shared savings and will approve
or deny the ACO’s prepaid shared
savings application accordingly. CMS
may review an ACO’s spend plan at any
time and require the ACO to modify its
spend plan to comply with the
requirements of this paragraph (d) and
paragraph (e) of this section.
(e) Use and management of prepaid
shared savings—(1) Allowable uses. An
ACO must use prepaid shared savings to
improve the quality and efficiency of
items and services furnished to
beneficiaries by investing in staffing,
healthcare infrastructure, and direct
beneficiary services. Expenditures of
prepaid shared savings must comply
with paragraph (e)(2) of this section, the
beneficiary incentive provision at
§ 425.304(a), (b), and (d), and all other
applicable laws and regulations.
(i) An ACO may spend up to 50
percent of its estimated annual prepaid
shared savings on staffing and
healthcare infrastructure in each
performance year.
(ii) An ACO may spend up to 100
percent, but not less than 50 percent, of
its estimated annual prepaid shared
savings on direct beneficiary services in
each performance year.
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(2) Prohibited uses. An ACO may not
use prepaid shared savings for any
expense other than those allowed under
paragraph (e)(1) of this section.
Prohibited uses include the following—
(i) Management company or parent
company profit;
(ii) Performance bonuses;
(iii) Provision of medical services
covered by Medicare;
(iv) Cash or cash equivalent payments
to patients;
(v) Items or activities unrelated to
ACO operations or care of beneficiaries;
and
(vi) In the case of an ACO
participating in Levels C through E of
the BASIC track or the ENHANCED
track, the repayment of any shared
losses incurred as specified in a written
notice in accordance with
§ 425.605(e)(2) or § 425.610(h)(2),
respectively.
(3) Duration for spending payments.
An ACO must spend all prepaid shared
savings in the agreement period in
which they are received. An ACO must
repay to CMS any unspent funds
remaining at the end of each agreement
period. Any unspent funds received for
a performance year must be reallocated
in the spend plan for the ACO’s next
performance year. When reallocated in
the spend plan for the next performance
year, the total unspent funds in each
category must be reallocated within
their originally indicated category
specified in accordance with paragraph
(d)(2) of this section. If an ACO fails to
spend a majority of the prepaid shared
savings they receive in a performance
year, CMS may withhold future
quarterly payments until the ACO
spends the funding they have already
received and reports this spending to
CMS through an updated spend plan.
(f) Payment & payment methodology.
An ACO determined eligible pursuant to
paragraph (b) of this section receives
quarterly prepaid shared savings
payments equal to the maximum
quarterly payment amount calculated
pursuant to the methodology specified
in paragraphs (f)(2) through (4) of this
section unless the ACO elects to receive
a lesser amount pursuant to paragraph
(f)(6) of this section. CMS notifies in
writing each ACO of its determination
of the amount of prepaid shared savings
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 prepaid
shared savings payment, the notice will
specify the reason(s) why and inform
the ACO of its right to request
reconsideration review in accordance
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with the procedures specified in subpart
I.
(1) Frequency of payments. An ACO
will receive quarterly prepaid shared
savings payments for the entirety of the
ACO’s agreement period unless the
payment is withheld or terminated
pursuant to paragraph (h) of this
section. If an ACO’s quarterly payment
is withheld or terminated pursuant to
paragraph (h), the ACO will not receive
additional or catch-up payments if
quarterly prepaid shared savings
payments are later resumed.
(2) Calculating the prepaid shared
savings multiplier. (i) Calculate total per
capita savings or losses for each
performance year that constitutes BY1
and BY2 of the agreement period in
which the ACO receives prepaid shared
savings. Per capita savings or losses will
be set to zero for a performance year if
the ACO was not reconciled for the
performance year.
(ii) Take the simple average of the per
capita savings or losses calculated in
paragraph (f)(2)(i) of this section,
including values of zero, if applicable.
(iii) Apply a proration factor to
account for any upward growth in the
ACO’s assigned population in BY1 and
BY2 of the agreement period in which
the ACO receives prepaid shared
savings as compared to the size of the
assigned population when the ACO was
reconciled for the corresponding
performance years in its prior agreement
period.
(iv) Adjust the pro-rated average per
capita amount computed in paragraph
(f)(2)(iii) of this section by multiplying
by 50 percent.
(v) The prepaid shared savings
multiplier is the lesser of the following:
(A) Two-thirds of the pro-rated,
adjusted average per capita amount
computed in paragraph (f)(2)(iv) of this
section.
(B) 5 percent of national per capita
expenditures for Parts A and B services
under the original Medicare fee-forservice program in BY2 for assignable
beneficiaries identified for the 12-month
calendar year corresponding to BY2
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.
(3) Recalculation of the prepaid
shared savings multiplier during an
agreement period. For the first
performance year during the term of the
agreement period in which the ACO
receives prepaid shared savings, the
ACO’s prepaid shared savings
multiplier is recalculated for changes in
per capita shared savings or losses for
the performance years used in the
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calculation of the prepaid shared
savings multiplier 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 in which
the ACO receives prepaid shared
savings, the ACO’s prepaid shared
savings multiplier is recalculated 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, and
for changes in per capita shared savings
or losses for the performance years used
in the calculation of the prepaid shared
savings multiplier as a result of issuance
of a revised initial determination under
§ 425.315. To recalculate the prepaid
shared savings multiplier, CMS does the
following:
(i) Takes into account changes to the
ACO’s savings or losses for a
performance year for either of the 2
years that constitute BY1 and BY2 of the
agreement period for which the ACO
receives prepaid shared savings under
paragraph (f)(2)(i) of this section,
including values of zero, if applicable,
as a result of issuance of a revised initial
determination under § 425.315, when
calculating the simple average of the per
capita savings or losses calculated in
paragraph (f)(2)(ii) of this section.
(ii) Redetermines the proration factor
used in calculating the prepaid shared
savings multiplier under paragraph
(f)(2)(iii) of this section to account for
changes in the ACO’s assigned
beneficiary population in the
benchmark years of the ACO’s
agreement period in which the ACO
receives prepaid shared savings 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), or changes to the
beneficiary assignment methodology
under subpart E of this part.
(4) Calculating the maximum
quarterly payment amount. For each
quarter for each performance year, the
maximum quarterly prepaid shared
savings amount is equal to the product
of one-fourth of the prepaid shared
savings multiplier calculated in
paragraph (f)(2)(v) of this section or
recalculated according to paragraph
(f)(3) of this section and the ACO’s
performance year assigned beneficiary
person years calculated from the ACO’s
most recent assignment list.
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(5) Estimated annual payment
amount calculation methodology. For
the purposes of determining the amount
of prepaid shared savings permitted to
be allocated to the uses specified in
paragraph (e) of this section during each
performance year, the estimated annual
prepaid shared savings amount can be
calculated by multiplying the first
quarterly payment amount the ACO
receives in each performance year by
four. If an ACO’s maximum quarterly
payments decrease over the
performance year, the ACO will not be
subject to compliance action solely
because it spent more than 50 percent
of the actual annual amount of prepaid
shared savings it received during that
PY on staffing and healthcare
infrastructure, as long as it did not
spend more than 50 percent of the
originally estimated annual maximum
prepaid shared savings amount on
staffing and healthcare infrastructure.
(6) ACO selection of quarterly
payment amount. An ACO may request
a smaller quarterly payment amount
from CMS in a form and manner and by
a deadline specified by CMS.
(g) Recoupment and recovery of
prepaid shared savings; notice of
bankruptcy. (1) CMS will recoup
prepaid shared savings made to an ACO
from any shared savings the ACO earns
until CMS has recouped in full the
amount of prepaid shared savings made
to the ACO. CMS will carry forward any
remaining balance owed to subsequent
performance year(s) in which the ACO
achieves shared savings.
(2) If the amount of shared savings
earned by the ACO is revised upward by
CMS for any reason, CMS will reduce
the redetermined amount of shared
savings by the amount of prepaid shared
savings made to the ACO as of the date
of the redetermination. If the amount of
shared savings earned by the ACO is
revised downward by CMS for any
reason, the ACO will not receive a
refund of any portion of the prepaid
shared savings previously recouped or
otherwise repaid, and any prepaid
shared savings that are now outstanding
due to the revision in earned shared
savings must be repaid to CMS upon
request.
(3) If an ACO has an outstanding
balance of prepaid shared savings after
the calculation of shared savings or
losses for the final performance year of
an agreement period in which an ACO
receives prepaid shared savings, the
ACO must repay any outstanding
amount of prepaid shared savings it
received in full upon request from CMS.
CMS will provide written notification to
the ACO of the amount due and the
ACO must pay such amount no later
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than 90 days after the receipt of
notification. If the ACO fails to repay
any outstanding amount of prepaid
shared savings within 90 days of that
written notification, CMS will recoup
any outstanding balance of prepaid
shared savings from the ACO’s
repayment mechanism established
under § 425.204(f). CMS may also
recover any outstanding amount of
prepaid shared savings owed by
recouping from any future shared
savings the ACO may be eligible to
receive in a subsequent agreement
period.
(4) Except as provided in paragraph
(g)(4)(ii) of this section, if an ACO or
CMS terminates the ACOs participation
agreement during the agreement period
in which it received prepaid shared
savings, the ACO must repay all
outstanding prepaid shared savings it
received in full upon request from CMS.
(i) 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
notification. If the ACO fails to repay
within 90 days, CMS will recoup any
outstanding balance from the ACO’s
repayment mechanism established
under § 425.204(f).
(ii) If the ACO terminates its current
participation agreement under § 425.220
and immediately enters a new
agreement period to continue its
participation in the program, CMS may
recover the amount owed by recouping
from any future shared savings the ACO
may be eligible to receive in subsequent
agreement periods.
(5)(i) If an ACO has filed a bankruptcy
petition, whether voluntary or
involuntary, the ACO must provide
written notice of the bankruptcy to CMS
and to the U.S. Attorney’s Office in the
district where the bankruptcy was filed,
unless final payment for the agreement
period has been made by either CMS or
the ACO and all administrative or
judicial review proceedings relating to
any payments under the Shared Savings
Program have been fully and finally
resolved.
(ii) The notice of bankruptcy must be
sent by certified mail no later than 5
days after the petition has been filed
and must contain a copy of the filed
bankruptcy petition (including its
docket number). The notice to CMS
must be addressed to the CMS Office of
Financial Management at 7500 Security
Boulevard, Mailstop C3–01–24,
Baltimore, MD 21244 or such other
address as may be specified on the CMS
website for purposes of receiving such
notices.
(h) Withholding or termination of
prepaid shared savings—(1) General.
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Except as provided in paragraph (h)(2)
of this section, CMS may withhold or
terminate an ACO’s prepaid shared
savings during an agreement period if—
(i) The ACO fails to comply with the
requirements of this section;
(ii) The ACO meets any of the grounds
for ACO termination set forth in
§ 425.218(b);
(iii) The ACO fails to earn sufficient
shared savings in a performance year to
repay the prepaid shared savings they
received during that performance year;
(iv) CMS determines that the ACO is
not expected to earn shared savings in
a performance year during the
agreement period in which the ACO
received prepaid shared savings based
on a rolling 12-month window of
beneficiary claims data or year to date
beneficiary claims data;
(v) The ACO falls below 5,000
assigned beneficiaries;
(vi) The ACO fails to spend the
majority of prepaid shared savings they
receive in a performance year; or
(vii) The ACO requests that CMS
withhold a future quarterly prepaid
shared savings payment.
(2) Eligibility sanction. CMS must
terminate an ACO’s prepaid shared
savings if—
(i) The ACO fails to maintain an
adequate repayment mechanism in
accordance with § 425.204(f); or
(ii) The ACO fails to meet the quality
performance standard as specified
under § 425.512 or is subject to a pretermination action after CMS
determined the ACO avoided at-risk
beneficiaries as specified under
§ 425.316(b)(2).
(3) No additional payments. If CMS
withholds or terminates a quarterly
payment pursuant to this paragraph (h),
the ACO will not receive additional or
catch-up payments if quarterly
payments of prepaid shared savings are
later resumed.
(4) No pre-termination actions. CMS
may immediately terminate an ACO’s
prepaid shared savings under
paragraphs (h)(1) and (2) of this section
without taking any of the pretermination actions set forth in
§ 425.216.
(i) Reporting information on prepaid
shared savings. The ACO must report
information on its receipt of and use of
prepaid shared savings, as follows:
(1) The ACO must publicly report
information about the ACO’s use of
prepaid shared savings for each
performance year, in accordance with
§ 425.308(b)(10).
(2) In a form and manner and by a
deadline specified by CMS, the ACO
must report to CMS the same
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information it is required to publicly
report under § 425.308(b)(10).
§ 425.650
[Amended]
72. Section 425.650 is amended in
paragraph (a) by removing the reference
‘‘425.660’’ and adding in its place the
reference ‘‘425.662’’.
■ 73. Section 425.652 is amended by—
■ a. Revising paragraph (a)(8) and
paragraph (a)(9) introductory text;
■ b. Redesignating paragraphs (a)(9)(v)
and (vi) as paragraphs (a)(9)(vi) and
(vii), respectively;
■ c. Adding new paragraph (a)(9)(v);
■ d. Revising newly redesignated
paragraph (a)(9)(vi); and
■ e. Adding paragraphs (a)(9)(viii) and
(ix).
The revisions and additions read as
follows:
■
§ 425.652 Establishing, adjusting, and
updating the benchmark for agreement
periods beginning on January 1, 2024, and
in subsequent years.
(a) * * *
(8) Adjusts the historical benchmark,
if applicable:
(i) For agreement periods beginning
on January 1, 2024, except as provided
in paragraph (a)(8)(i)(C) of this section,
CMS 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:
(A) Computes the regional adjustment
in accordance with § 425.656 and the
prior savings adjustment in accordance
with § 425.658.
(B) 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 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.
(C) 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 value
as described in § 425.656(d), is negative
or zero, the ACO will not receive an
adjustment to its benchmark.
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(D) 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:
(1) 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.
(2) 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.
(E) 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.
(ii) For agreement periods beginning
on January 1, 2025, and in subsequent
years, except as provided in paragraph
(a)(8)(ii)(B)(2) of this section, CMS
adjusts the historical benchmark based
on the ACO’s regional service area
expenditures (as specified under
§ 425.656), 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), or to
account for the ACO serving higher
proportions of underserved beneficiaries
(as specified in § 425.662). CMS does all
of the following to determine the
adjustment, if any, applied to the
historical benchmark:
(A) Computes the regional adjustment
in accordance with § 425.656, the prior
savings adjustment in accordance with
§ 425.658, and the health equity
benchmark adjustment (HEBA) in
accordance with § 425.662.
(B) Compares the regional adjustment,
expressed as a single value as described
in § 425.656(d), the per capita prior
savings adjustment determined in
§ 425.658(c), if any, and the HEBA
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determined in § 425.662(b), if any, to
determine the adjustment applied to the
historical benchmark.
(1) The ACO will receive the highest
of the positive adjustments for which it
is eligible. The adjustment will be
calculated as described in § 425.656(c),
§ 425.658(c), or § 425.662(b),
respectively, 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.
(2) If an ACO is not eligible to receive
a prior savings adjustment under
§ 425.658(b)(3)(i) or the HEBA under
§ 425.662(b)(3), and the regional
adjustment, expressed as a single value
as described in § 425.656(d), is negative
or zero, the ACO will not receive an
adjustment to its benchmark.
(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, and for changes in values
used in benchmark calculations as a
result of the performance year being
affected by significant, anomalous, and
highly suspect billing under § 425.672.
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, 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, and for
changes in values used in benchmark
calculations as a result of the
performance year being affected by
significant, anomalous, and highly
suspect billing under § 425.672. To
adjust the benchmark, CMS does the
following:
*
*
*
*
*
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(v) Redetermines the HEBA scaler
used in calculating the HEBA under
§ 425.662(b)(2) to account for changes in
the ACO’s regional adjustment or prior
savings adjustment in accordance with
paragraphs (a)(9)(ii) through (iv) of this
section.
(vi) In accordance with paragraph
(a)(8) of this section, CMS redetermines
the adjustment to the historical
benchmark based on the redetermined
regional adjustment (as specified under
§ 425.656), the prior savings adjustment
(as specified under § 425.658), or the
HEBA (as specified under § 425.662) if
applicable.
*
*
*
*
*
(viii) Recalculates benchmark year
expenditures to account for the impact
of improper payments, for the
benchmark year corresponding to a
performance year for which CMS issued
a revised initial determination under
§ 425.315. In recalculating expenditures
for the benchmark year, CMS applies
the calculation methodology applied in
recalculating expenditures for the
corresponding performance year in
accordance with § 425.674.
(ix) Recalculates expenditures used in
Shared Savings Program benchmark
calculations under this section, and as
applicable under §§ 425.654 through
425.662, to exclude the same HCPCS or
CPT codes identified as displaying
significant, anomalous, and highly
suspect billing patterns in calculation of
performance year expenditures, in
accordance with § 425.672.
*
*
*
*
*
■ 74. Section 425.655 is amended by
revising paragraph (d)(2) to read as
follows:
§ 425.655 Calculating the regional risk
score growth cap adjustment factor.
*
*
*
*
*
(d) * * *
(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 historical benchmark
expenditures, adjusted in accordance
with § 425.652(a)(8), for that enrollment
type and the ACO’s performance year
assigned beneficiary person years for
that enrollment type.
*
*
*
*
*
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62229
75. Section 425.658 by revising
paragraph (d) to read as follows:
■
§ 425.658 Calculating the prior savings
adjustment to the historical benchmark.
*
*
*
*
*
(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), and the HEBA as
determined in § 425.662(b), if any, to
determine the adjustment, if any, that
will be applied to the ACO’s benchmark
in accordance with § 425.652(a)(8).
*
*
*
*
*
■ 76. Section 425.662 is added to read
as follows:
§ 425.662 Calculating the health equity
adjustment to the historical benchmark.
(a) General. For agreement periods
beginning on January 1, 2025, and in
subsequent years, CMS calculates a
health equity adjustment to the
historical benchmark (HEBA) to account
for ACOs serving higher proportions of
underserved beneficiaries.
(b) Calculation of the health equity
benchmark adjustment. To calculate the
adjustment described in paragraph (a) of
this section, CMS does all of the
following:
(1) Calculates the weighted average of
the ACO’s third benchmark year (BY3)
national per capita expenditure amounts
across the following populations of
beneficiaries, where the weights are the
ACO’s BY3 proportion of assigned
beneficiaries for that enrollment type:
(i) ESRD.
(ii) Disabled.
(iii) Aged/dual eligible Medicare and
Medicaid beneficiaries.
(iv) Aged/non-dual eligible Medicare
and Medicaid beneficiaries.
(2) Calculates the HEBA scaler as the
difference between 5 percent of the
national per capita expenditure amount,
expressed as single value as calculated
in paragraph (b)(1) of this section, and
the higher of: the regional adjustment,
expressed as a single value as described
in § 425.656(d); the per capita prior
savings adjustment determined in
§ 425.658(c); or no adjustment, in the
case where the regional adjustment is
negative and the ACO is not eligible for
the prior savings adjustment under
§ 425.658(b)(3)(i).
(3) Determines the ACO’s eligibility
for the HEBA based on the proportion
of the ACO’s assigned beneficiaries for
the performance year who are enrolled
in the Medicare Part D low-income
subsidy (LIS) or dually eligible for
Medicare and Medicaid. An ACO is
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only eligible for the HEBA if this
proportion is greater than or equal to 20
percent. An ACO with a proportion less
than 20 percent is ineligible to receive
a HEBA.
(4) Calculates the HEBA. If the ACO
is eligible for the HEBA as determined
in paragraph (b)(3) of this section, the
HEBA is equal to the product of the
HEBA scaler calculated in paragraph
(b)(2) of this section and the proportion
of the ACO’s assigned beneficiaries for
the performance year who are enrolled
in the Medicare Part D LIS or dually
eligible for Medicare and Medicaid.
(c) Applicability of the HEBA. CMS
compares the HEBA determined in
paragraph (b)(4) of this section with the
regional adjustment, expressed as a
single value as described in
§ 425.656(d), and the per capita prior
savings adjustment determined in
§ 425.658(c), if any, to determine the
adjustment, if any, that will be applied
to the ACO’s benchmark in accordance
with § 425.652(a)(8)(ii).
§ § 425.664
Reserved]
through 425.669 [Added and
77. Sections 425.664 through 425.669
are added and reserved.
■ 78. Section 425.672 is added to read
as follows:
■
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§ 425.672 Adjustments to mitigate the
impact of significant, anomalous, and
highly suspect billing activity on Shared
Savings Program financial calculations
involving calendar year 2024 or subsequent
calendar years.
(a) General. This section describes
adjustments CMS may make to Shared
Savings Program calculations to mitigate
the impact of significant, anomalous,
and highly suspect billing activity
occurring in calendar year 2024 or
subsequent calendar years.
(b) Significant, anomalous, and highly
suspect billing activity for a HCPCS or
CPT code impacting Shared Savings
Program calculations. CMS, at its sole
discretion, may determine that the
billing of one or more specified HCPCS
or CPT codes represents significant,
anomalous, and highly suspect billing
activity for a calendar year that warrants
adjustment to calculations made under
this part.
(c) Applicability of adjustments to
performance year and benchmark year
calculations. Notwithstanding any other
provision in this part, CMS adjusts the
following Shared Savings Program
calculations, as applicable, to exclude
all Medicare Parts A and B fee-forservice payment amounts on claims for
the specified claim types associated
with a HCPCS or CPT code identified
pursuant to paragraph (b) of this section
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for the periods identified in paragraph
(d) of this section:
(1) Calculation of Medicare Parts A
and B fee-for-service expenditures for an
ACO’s assigned beneficiaries for all
purposes including the following:
Establishing, adjusting, updating, and
resetting the ACO’s historical
benchmark and determining
performance year expenditures.
(2) Calculation of fee-for-service
expenditures for assignable beneficiaries
as used in determining county-level feefor-service expenditures and national
Medicare fee-for-service expenditures,
including the following calculations:
(i) Determining average county feefor-service expenditures based on
expenditures for the assignable
population of beneficiaries in each
county in the ACO’s regional service
area according to §§ 425.601(c) and
425.654(a) for purposes of calculating
the ACO’s regional fee-for-service
expenditures.
(ii) Determining the 99th percentile of
national Medicare fee-for-service
expenditures for assignable beneficiaries
for purposes of the following:
(A) Truncating assigned beneficiary
expenditures used in calculating
benchmark expenditures under
§§ 425.601(a)(4) and 425.652(a)(4), and
performance year expenditures under
§§ 425.605(a)(3) and 425.610(a)(4).
(B) Truncating expenditures for
assignable beneficiaries in each county
for purposes of determining county feefor-service expenditures according to
§§ 425.601(c)(3) and 425.654(a)(3).
(C) Truncating expenditures for
assignable beneficiaries for purposes of
determining truncated national per
capita fee-for service expenditures for
purposes of calculating the ACPT
according to § 425.660(b)(3).
(iii) Determining truncated national
per capita fee-for-service Medicare
expenditures for assignable beneficiaries
for purposes of calculating the ACPT
according to § 425.660(b)(3).
(iv) Determining national per capita
expenditures for Parts A and B services
under the original Medicare fee-forservice program 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 § 425.658(c)(1)(ii), capping
the prepaid shared savings multiplier
according to § 425.640(f)(2)(v), and
calculating the HEBA scaler according
to § 425.662(b)(2).
(v) Determining national growth rates
that are used as part of the blended
growth rates used to trend forward BY1
and BY2 expenditures to BY3 according
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to §§ 425.601(a)(5)(ii) and
425.652(a)(5)(ii) and as part of the
blended growth rates used to update the
benchmark according to §§ 425.601(b)(2)
and 425.652(b)(2)(i).
(3) Calculation of Medicare Parts A
and B fee-for-service revenue of ACO
participants for purposes of calculating
the ACO’s loss recoupment limit under
the BASIC track as specified in
§ 425.605(d).
(4) Calculation of total Medicare Parts
A and B fee-for-service revenue of ACO
participants and total Medicare Parts A
and B fee-for-service expenditures for
the ACO’s assigned beneficiaries for
purposes of identifying whether an ACO
is a high revenue ACO or low revenue
ACO, as defined under § 425.20,
determining an ACO’s eligibility to
receive advance investment payments
according to § 425.630, and determining
whether an ACO qualifies for a shared
savings payment under § 425.605(h).
(5) Calculation or recalculation of the
amount of the ACO’s repayment
mechanism arrangement according to
§ 425.204(f)(4).
(d) Periods of adjustment. CMS
adjusts the Shared Savings Program
calculations identified in paragraph (c)
of this section for significant,
anomalous, and highly suspect billing
activity identified for calendar year
2024 or subsequent calendar years as
follows:
(1) The calendar year for which the
significant, anomalous, and highly
suspect billing activity was identified
pursuant to paragraph (b) of this section,
when it is either a performance year or
a benchmark year.
(2) The 3 most recent years prior to
the start of the ACO’s agreement period
used in establishing the historical
benchmark, when such a benchmark is
used to reconcile the ACO for a
performance year adjusted in
accordance with paragraph (d)(1) of this
section.
(e) Adjustments for growth rates used
in calculating the ACPT. In addition to
adjustments described in paragraph (c)
of this section, CMS makes adjustments
for payments associated with a HCPCS
or CPT code identified pursuant to
paragraph (b) of this section for any
calendar year corresponding to BY3 in
projecting per capita growth in Parts A
and B fee-for-service expenditures,
according to § 425.660(b)(1), for
purposes of calculating the ACPT for
agreement periods beginning on January
1, 2024, and in subsequent years.
■ 79. Section 425.674 is added to read
as follows:
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§ 425.674 Accounting for the impact of
improper payments on Shared Savings
Program financial calculations.
(a) General rule. Upon the reopening
of an initial determination pursuant to
§ 425.315(a)(4), CMS will use the
methodology specified in this section to
account for the impact of improper
payments when:
(1) Determining savings or losses for
the relevant performance year in
accordance with § 425.315 in order to
issue a revised initial determination.
(2) Adjusting the benchmark by
recalculating benchmark year
expenditures under §§ 425.601(a)(9)(iii)
and 425.652(a)(9)(viii) in the event that
CMS recalculates a payment
determination and issues a revised
initial determination for the
corresponding performance year in a
prior agreement period, in accordance
with paragraph (a)(1) of this section.
(b) Improper payment. For the
purpose of this section, improper
payment includes:
(1) An amount associated with a
demanded overpayment determination.
(2) An amount identified in a
settlement agreement or judgment,
pursuant to conduct by individuals or
entities performing functions or services
related to an ACO’s activities, less any
penalties or damages.
(c) Accounting for improper
payments. To adjust Medicare Parts A
and B fee-for-service expenditures for
improper payments CMS does the
following:
(1) Identify each Shared Savings
Program expenditure calculation for a
performance year or benchmark year, as
calculated according to the standard
methodology described in this subpart
and expressed as a per capita dollar
amount, that will be adjusted for the
impact of improper payments.
(2) Determine each specific
population of Medicare fee-for-service
beneficiaries used to calculate the
expenditure amount identified in
paragraph (c)(1) of this section. The
populations relevant for a specific
expenditure calculation may include:
(i) The population of beneficiaries
assigned to the ACO for calculating the
ACO’s performance year or benchmark
year expenditures.
(ii) The population of assignable
beneficiaries in each county in the
ACO’s regional service area for
calculating county-level expenditures.
(iii) The national population of
assignable beneficiaries for calculating
national assignable expenditures.
(iv) The national population of
Medicare fee-for-service beneficiaries
for calculating national expenditures.
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(3) Determine the per capita amount
of improper payments for the
performance year or benchmark year
included in the per capita Medicare
Parts A and B fee-for-service
expenditure amount for a population
identified in paragraph (c)(2) of this
section in accordance with paragraph
(d) of this section for all providers or
suppliers with identified improper
payments.
(4) Subtract the per capita amount
determined in paragraph (c)(3) of this
section from the expenditure calculation
identified in paragraph (c)(1) of this
section for the population identified in
paragraph (c)(2) of this section 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.
(5) If applicable, CMS will do the
following to adjust regional
expenditures for improper payments:
(i) Adjust county-level fee-for-service
expenditures determined under
paragraph (c)(4) of this section, for each
county in the ACO’s regional service
area, for severity and case mix of
assignable beneficiaries in the county
using prospective HCC risk scores. This
calculation is made for each of the
populations of beneficiaries identified
in paragraphs (c)(4)(i) through (iv) of
this section.
(ii) Weight the risk adjusted countylevel fee-for-service expenditures
determined under paragraph (c)(5)(i) of
this section according to the ACO’s
proportion of assigned beneficiaries in
the county, determined in accordance
with § 425.601(d)(1), § 425.603(f)(1), or
§ 425.654(b)(1), as applicable, for each
of the populations of beneficiaries
identified in paragraphs (c)(4)(i) through
(iv) of this section.
(iii) Aggregate the values determined
in paragraph (c)(5)(ii) of this section for
each of the populations of beneficiaries
identified in paragraphs (c)(4)(i) through
(iv) of this section across all counties
within the ACO’s regional service area.
(d) Determining the per capita
amount of improper payments. CMS
may use one or more of the following
approaches to determine the per capita
amount that will be used to adjust
expenditure calculations identified in
paragraph (c)(1) of this section:
(1) Calculate aggregate improper
payments attributable to a population
identified in paragraph (c)(2) of this
section for each provider or supplier
that had improper payments.
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(i) For improper payments associated
with specific claims, CMS will do the
following:
(A) For improper payments to a
provider or supplier that correspond to
payment amounts on claims or line
items that were used in a Shared
Savings Program calculation identified
in paragraph (c)(1) of this section, and
subsequently adjusted after the 3-month
claims run out period, CMS will sum
the improper payment amounts across
all such claims or line items with dates
of service during the period used to
calculate performance year or
benchmark year expenditures for the
population identified in paragraph (c)(2)
of this section.
(B) In the event CMS determines it is
necessary to account for the impact of
improper payments on Shared Savings
Program financial calculations by
adjusting the payment amounts for a
specific HCPCS or CPT code billed by
the provider or supplier for the
population identified in paragraph (c)(2)
of this section, CMS will do the
following—
(1) Identify the applicable claims or
line items with dates of service during
the period used to calculate
performance year or benchmark year
expenditures processed before the end
of the applicable 3-month claims run
out period;
(2) Sum the claim or line item
payment amounts, on the claims or line
items identified in paragraph
(d)(1)(i)(B)(1) of this section; and
(3) If applicable, multiply the sum
calculated in paragraph (d)(1)(i)(B)(2) of
this section by a scaling factor to
compute the payment differential
between the HCPCS or CPT code that
was improperly billed and a CMSidentified alternate code.
(ii) For aggregate improper payment
amounts that are not linked to specific
claims or line items, CMS will calculate
the amount attributable to the
population identified in paragraph (c)(2)
of this section by applying a proration
factor to the aggregate improper
payment amount identified for that
provider or supplier. CMS calculates the
proration factor as follows:
(A) The denominator of the proration
factor is total Medicare Parts A and B
claim or line item payment amounts to
the provider or supplier for all fee-forservice beneficiaries on claims of
specified claim types for the time period
associated with the aggregate improper
payment amount identified for the
provider or supplier that were made
before the end of the applicable 3-month
claims run out period.
(B) The numerator of the proration
factor is the portion of the total from the
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denominator, in paragraph (d)(1)(ii)(A)
of this section, that CMS determines is
attributable to the population identified
in paragraph (c)(2) of this section with
dates of service during the period used
to calculate expenditures for the
applicable performance year or
benchmark year.
(2) Sum the amounts calculated
pursuant to paragraph (d)(1) of this
section attributable to a population
identified in paragraph (c)(2) of this
section across all providers or suppliers
that had identified improper payments.
(3) Take the lesser of the following
two values—
(i) The sum from paragraph (d)(2) of
this section; or
(ii) Total Medicare Parts A and B
claim or line item payment amounts to
all providers or suppliers that had
improper payments for the population
identified in paragraph (c)(2) of this
section on claims of specified claim
types with dates of service within the
performance year or benchmark year
made before the end of the applicable 3month claims run out period.
(4) Express the lesser-of amount from
paragraph (d)(3) of this section as a per
capita value by dividing by the total
beneficiary person years in the
population identified in paragraph (c)(2)
of this section for the applicable
performance year or the benchmark
year.
■ 80. Part 427 is added to read as
follows:
PART 427—MEDICARE PART B DRUG
INFLATION REBATE PROGRAM
Subpart A—General Provisions
Sec.
427.10 Basis and scope.
427.20 Definitions.
Subpart B—Determination of Part B
Rebatable Drugs
427.100 Definitions.
427.101 Identification of Part B rebatable
drugs.
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Subpart C—Coinsurance Adjustment and
Adjusted Medicare Payment for Part B
Rebatable Drugs With Price Increases
Faster Than Inflation
427.200 Definitions.
427.201 Computation of beneficiary
coinsurance and adjusted Medicare
Payment for Part B rebatable drugs with
price increases faster than inflation.
Subpart D—Determination of the Rebate
Amount for Part B Rebatable Drugs
427.300 Definitions.
427.301 Calculation of the total Part B
rebate amount to be paid by
manufacturers.
427.302 Calculation of the per unit Part B
drug rebate amount.
427.303 Determination of total number of
billing units.
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427.304 Adjustments for changes to billing
and payment codes.
Subpart E—Reducing the Rebate Amount
for Part B Rebatable Drugs in Shortage and
When There Is a Severe Supply Chain
Disruption
427.400 Definitions.
427.401 Reducing the rebate amount for
Part B rebatable drugs currently in
shortage.
427.402 Reducing the rebate amount for
certain Part B rebatable drugs when there
is a severe supply chain disruption.
Subpart F—Reports of Rebate Amounts,
Reconciliation, Suggestion of Error, and
Payments
427.500 Definitions.
427.501 Rebate Reports and reconciliation.
427.502 Rebate Reports for applicable
calendar quarters in calendar years 2023
and 2024.
427.503 Suggestion of Error.
427.504 Manufacturer access to Rebate
Reports.
427.505 Deadline and process for payment
of rebate amount.
Subpart G—Enforcement of Manufacturer
Payment of Rebate Amounts
427.600 Civil money penalty notice and
appeals procedures.
Authority: 42 U.S.C. 1395w–3a(i), 1302,
and 1395hh.
Subpart A—General Provisions
§ 427.10
Basis and scope.
(a) Basis. This part implements
section 1847A(i) of the Social Security
Act (‘‘the Act’’).
(b) Scope. This part sets forth the
requirements of the Medicare Part B
Drug Inflation Rebate Program, which
requires, for each calendar quarter,
manufacturers to pay rebates for certain
single source drugs and biological
products with prices that increase faster
than the rate of inflation.
(c) Severability. Were any provision of
this part to be held invalid or
unenforceable by its terms, or as applied
to any person or circumstance, such
provisions would be severable from this
part and the invalidity or
unenforceability would not affect the
remainder thereof or any other part of
this subchapter or the application of
such provision to other persons not
similarly situated or to other, dissimilar
circumstances.
§ 427.20
Definitions.
As used in this part, the following
definitions apply:
Allowed charges means the amount
that is inclusive of the beneficiary
coinsurance and Medicare payment for
the covered Part B item or service.
Applicable calendar quarter means a
calendar quarter (January 1 to March 31,
April 1 to June 30, July 1 to September
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30, or October 1 to December 31) in
which an inflation rebate is applied,
starting with January 1, 2023.
Applicable threshold means the
amount calculated in accordance with
§ 427.101(c)(2).
Average sales price (ASP) means the
manufacturer’s price for a quarter for a
drug represented by a particular 11-digit
National Drug Code (NDC–11)
calculated in accordance with § 414.804
of this chapter.
Benchmark period Consumer Price
Index for All Urban Consumers (CPI–U)
means the CPI–U identified in
§ 427.302(e).
Billing and payment code means the
specific code used to classify and report
a drug or biological for purposes of
Medicare Part B payment. A Healthcare
Common Procedure Coding System
(HCPCS) code, as established by CMS, is
an example of a billing and payment
code used to describe a drug or
biological and for which CMS publishes
a payment amount.
Billing unit means the identifiable
quantity of a drug or biological product
associated with a billing and payment
code (for example, a HCPCS code), as
established by CMS.
Biosimilar biological product has the
meaning set forth in section
1847A(c)(6)(H) of the Act.
CPI–U means the monthly Consumer
Price Index for All Urban Consumers
(United States city average) index level
for all items from the Bureau of Labor
Statistics.
Food and Drug Administration (FDA)
application means, for the purposes of
calculating the Part B rebate amount, a
New Drug Application (NDA) or
Biologics License Application (BLA)
approved by the FDA.
Final action claim means a nonrejected claim for which a Medicare
payment has been made, and for which
all disputes and adjustments have been
resolved.
First marketed date means the earliest
date of first sale of any NDC–11 within
a billing and payment code among all
products and package sizes under the
same FDA application. The first
marketed date will be identified using
ASP data reported by NDC–11 to CMS
by a manufacturer as required under
sections 1927(b)(3)(A)(iii)(I) and
1847A(f)(2) of the Act, if available.
Grouped billing and payment code,
for the purposes of Part B rebate
calculations, means a billing and
payment code, such as a HCPCS code,
other than a Not Otherwise Classified
(NOC) code, that typically contains
multiple drug products approved under
multiple NDAs or BLAs and may be
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inclusive of, but are not limited to,
multiple source billing codes.
Inflation-adjusted payment amount
means the amount calculated in
§ 427.302(g).
Manufacturer has the meaning set
forth in section 1847A(c)(6)(A) of the
Act.
National Drug Code (NDC) means the
unique identifying prescription drug
product number that is listed with FDA
identifying the product and package size
and type.
Not Otherwise Classified (NOC) code
means a billing and payment code,
including an unclassified, unspecified,
or unlisted code, for drugs and
biological products for which no
specific billing and payment code is
assigned.
Part B rebatable drug means, subject
to the exclusions described in
§ 427.101(b), a single source drug or
biological product, including a
biosimilar biological product but
excluding a qualifying biosimilar
biological product, for which payment
is made under Part B.
Payment amount benchmark quarter
means the calendar quarter identified in
§ 427.302(c).
Payment amount in the payment
amount benchmark quarter means the
amount identified in § 427.302(d).
Rebate period CPI–U means the CPI–
U identified in § 427.302(f).
Single source drug or biological
product has the meaning set forth in
section 1847A(c)(6)(D) of the Act.
Specified amount refers to the amount
identified in § 427.302(b).
Subsequently approved drug means a
drug first approved or licensed by the
FDA after December 1, 2020.
Unit means, with respect to a Part B
rebatable drug, with respect to each
National Drug Code (including package
size) associated with a drug or
biological, the lowest identifiable
quantity (such as a capsule or tablet,
milligram of molecules, or grams) of the
drug or biological that is dispensed,
exclusive of any diluent without
reference to volume measures pertaining
to liquids as reported under section
1847A(b)(2)(B) of the Act.
Subpart B—Determination of Part B
Rebatable Drugs
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§ 427.100
Definitions.
As used in this subpart, the following
definitions apply:
EUA Declaration refers to the March
27, 2020, Emergency Use Authorization
(EUA) Declaration for Drugs and
Biological Products under section 564 of
the Food, Drug, and Cosmetic (FD&C)
Act.
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and tissue-based products that aid
wound healing.
(6) Drugs with average total allowed
charges under the applicable threshold.
Drugs and biological products for which
the Medicare Part B average total
allowed charges for a year per
individual that uses such drug or
biological are below the applicable
threshold, as described in paragraph (c)
of this section.
§ 427.101 Identification of Part B rebatable
(7) Certain vaccines and other
drugs.
products. The following products:
(i) The vaccines described in section
(a) Determination of Part B rebatable
1861(s)(10) of the Act, which includes
drugs. (1) For each applicable calendar
the influenza, pneumococcal, hepatitis
quarter, CMS will:
B, and COVID–19 vaccines.
(i) Identify single source drugs or
(ii) Monoclonal antibodies used for
biological products, including
treatment or post-exposure prophylaxis
biosimilar biological products, covered
of COVID–19 that are covered and paid
under Part B; and
(ii) Identify the applicable billing and for under section 1861(s)(10) of the Act.
This exclusion will apply to applicable
payment code for each drug or
quarters until the end of the calendar
biological product identified in
year in which the EUA Declaration
paragraph (a)(1)(i) of this section.
ends.
(2) For a drug or biological product
(iii) Monoclonal antibodies that are
identified under paragraph (a)(1) of this
used for pre-exposure prophylaxis of
section, CMS will determine whether
the drug or biological product meets the COVID–19 that are covered and paid for
under section 1861(s)(10) of the Act.
exclusion criteria described in
This exclusion will apply to applicable
paragraph (b) or (c) of this section as of
calendar quarters even after the year in
the first day of the applicable calendar
which the EUA Declaration ends, as
quarter.
long as after the EUA Declaration is
(3) To determine whether a drug or
terminated, these products have an
biological product is a Part B rebatable
FDA-approved application or license.
drug under this section, CMS will use
(8) Generic drugs. Part B drugs
the most recent available data submitted
approved under an Abbreviated New
to CMS by manufacturers pursuant to
Drug Application (ANDA) submitted
section 1927(b)(3)(A)(iii) of the Act or
under section 505(j) of the Federal Food,
section 1847A(f)(2), as applicable, and
Drug, and Cosmetic Act (FD&C Act).
other available data, including but not
(c) Drugs and biological products with
limited to information available at
average total allowed charges below the
FDA.gov and information in drug
applicable threshold. For each
pricing compendia, as applicable.
applicable calendar quarter, CMS will
(b) Excluded product categories. The
identify drugs and biological products
following categories of products are not
with Part B average total allowed
considered Part B rebatable drugs:
charges for a year per individual that
(1) Qualifying biosimilar biological
uses such a drug or biological product
products. Biological products as defined that are below the applicable threshold
under section 1847A(b)(8)(B)(iii) of the
in accordance with the calculations
Act.
described in this section. Such drugs
(2) Products with historically excepted and biological products are not
grouped billing and payment codes.
considered Part B rebatable drugs and
Single source drugs or biological
will be excluded from the identification
products that were within the same
of Part B rebatable drugs in paragraph
billing and payment code as of October
(a) of this section.
1, 2003, and which, as required under
(1) Average total allowed charges for
section 1847A(c)(6)(C)(ii) of the Act, are a year per individual. For each drug or
treated as multiple source drugs.
biological that is identified in
(3) Products billed under a NOC code. accordance with paragraph (a) of this
A drug or biological product billed
section, CMS will calculate average total
under a NOC code.
allowed charges for a year per
(4) Radiopharmaceutical drugs and
individual as follows:
biological products. A separately
(i) For single source drugs and
payable radiopharmaceutical drug or
biological products assigned to only one
biological product not paid under
billing and payment code, CMS will
section 1847A of the Act.
sum the allowed charges from final
action claims greater than $0 and divide
(5) Skin substitutes. A product
the summed amount by the number of
included within the suite of cellularIndividual who uses such a drug or
biological means a unique Medicare Part
B beneficiary who was furnished the
Part B drug or biological that was
covered under Part B during the
applicable calendar quarter, identified
using final action claims data with dates
of service during the calendar year
described in § 427.101(b)(6) and with
allowed charges greater than zero.
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individuals who use such a drug or
biological with allowed charges for this
billing and payment code.
(ii) For single source drugs and
biological products assigned to more
than one billing and payment code,
CMS will sum the allowed charges from
final action claims greater than $0 for all
billing and payment codes and divide
the summed amount by the number of
individuals who use such a drug or
biological with allowed charges for
these billing and payment codes.
(iii) For single source drugs and
biological products previously
crosswalked to a grouped billing and
payment code:
(A) If crosswalked to a grouped billing
and payment code during the full year,
CMS will calculate the average total
allowed charges per individual per year
for the drug using allowed charges and
the number of individuals who used the
drug or biological product based on
claims for the previously grouped
billing and payment code during the
year.
(B) If crosswalked to a grouped billing
and payment code and later assigned to
a unique billing and payment code for
part of the year, CMS will calculate
average total allowed charges per
individual per year by:
(1) Summing the total allowed charges
billed under the unique billing and
payment code for the drug with dates of
service on or after the Medicare effective
date for this unique billing and payment
code and identifying the individuals on
those claims.
(2) Summing the total allowed charges
on claims billed under the previously
grouped billing and payment code and
identifying individuals with claims
prior to the unique billing and payment
code’s effective date.
(3) Summing the total allowed charges
as determined in paragraphs
(c)(1)(iii)(B)(1) and (2) of this section
and dividing by the total number of
individuals, de-duplicated for
individuals identified under paragraphs
(c)(1)(iii)(B)(1) and (2).
(2) Applicable threshold. CMS will
calculate the applicable threshold for an
applicable calendar quarter as follows:
(i) For applicable calendar quarters in
2023, the applicable threshold is equal
to $100.
(ii) For applicable calendar quarters in
2024, the applicable threshold is equal
to $100 increased by the percentage
increase in the CPI–U for the 12-month
period ending with June of 2023.
(iii) For applicable calendar quarters
in each subsequent calendar year, the
applicable threshold is equal to the
unrounded applicable threshold
calculated for the prior calendar year
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increased by the percentage increase in
the CPI–U for the 12-month period
ending with June of the previous year.
(iv) If the resulting amount under
paragraphs (c)(2)(i) through (iii) of this
section is not a multiple of $10, CMS
will round that amount to the nearest
multiple of $10.
(3) Application of the applicable
threshold at the billing and payment
code level. For each applicable calendar
quarter, CMS will apply the exclusion of
drugs and biological products identified
in paragraph (c)(1) of this section, with
average total allowed charges for a year
per individual less than the applicable
threshold described in paragraph (c)(2)
of this section, to applicable billing and
payment codes as follows:
(i) For single source drugs or
biological products assigned to a unique
billing and payment code, CMS will
exclude the assigned billing and
payment code for an applicable calendar
quarter if the average total allowed
charges for a year per individual are less
than the applicable threshold.
(ii) For a single source drug or
biological product that is assigned to
more than one billing and payment code
during a year, CMS will exclude all
such assigned billing and payment
codes for an applicable calendar quarter.
(4) Definition of year. For purposes of
the calculations described in this
section, a year is defined as the 4
consecutive calendar quarters beginning
6 calendar quarters before the applicable
calendar quarter. CMS will use final
action claims from the Medicare fee-forservice claims repository where separate
payment was allowed for the applicable
billing and payment code for dates of
service within a year to calculate Part B
average total allowed charges for that
year.
Subpart C—Coinsurance Adjustment
and Adjusted Medicare Payment for
Part B Rebatable Drugs With Price
Increases Faster Than Inflation
§ 427.200
Definitions.
As used in this subpart, inflationadjusted beneficiary coinsurance means
the coinsurance adjustment as
calculated in accordance with this
subpart.
§ 427.201 Computation of beneficiary
coinsurance and adjusted Medicare
payment for Part B rebatable drugs with
price increases faster than inflation.
(a) Methodology. CMS must use the
methodology set forth in this section to
calculate the inflation-adjusted
beneficiary coinsurance and associated
adjusted Medicare payment percentage
for Part B rebatable drugs as set forth in
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§§ 410.152(m), 419.41(e), and
489.30(b)(6) of this chapter.
(b) Calculation of inflation-adjusted
beneficiary coinsurance. To calculate
the inflation-adjusted beneficiary
coinsurance for Part B rebatable drugs
with respect to a calendar quarter, CMS
compares the payment amount, as
described in paragraph (b)(3) of this
section, to the inflation-adjusted
payment amount for the applicable
calendar quarter.
(1) If the payment amount exceeds the
inflation-adjusted payment amount, the
inflation-adjusted beneficiary
coinsurance is calculated by
multiplying the inflation-adjusted
payment amount by 0.20.
(2) If the inflation-adjusted payment
amount does not exceed the payment
amount, the adjustment to the
beneficiary coinsurance described in
paragraph (b)(1) of this section is not
applied.
(3) CMS will use the published
payment amount in quarterly pricing
files published by CMS as the payment
amount in this determination.
(c) Exclusions. Any drug that is
excluded from Part B rebatable drugs in
accordance with § 427.101(b) is not
subject to inflation-adjusted beneficiary
coinsurance.
Subpart D—Determination of the
Rebate Amount for Part B Rebatable
Drugs
§ 427.300
Definitions.
As used in this subpart, the following
definitions apply:
340B Program is the program under
section 340B of the Public Health
Service (PHS) Act.
Refundable single-dose container or
single-use package drug has the
meaning set forth in § 414.902 of this
chapter.
§ 427.301 Calculation of the total Part B
rebate amount to be paid by manufacturers.
(a) Total rebate. Subject to paragraph
(b) of this section, the total rebate
amount to be paid for a Part B rebatable
drug, as identified under § 427.101, for
an applicable calendar quarter is equal
to the product of the per unit Part B
rebate amount of such drug, as
determined under § 427.302, and the
billing units of the Part B rebatable drug
furnished during the applicable
calendar quarter, as identified in
accordance with § 427.303. The rebate
amount may be reduced in accordance
with subpart E of this part or adjusted
in accordance with subpart F of this
part.
(b) Apportionment of the Part B rebate
amount. CMS will identify billing and
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payment codes for which multiple
manufacturers report ASP, in
accordance with sections 1927(b)(3) and
1847A(f) of the Act, for NDCs assigned
to the billing and payment code. CMS
will calculate the rebate amount owed
by each manufacturer by:
(1) Determining the total billing units
sold for each NDC assigned to the
billing and payment code, by
multiplying the number of units
reported by a manufacturer in ASP data
submissions at the NDC–11 package
level by the number of billing units per
NDC–11 reporting unit.
(2) Summing the individual
manufacturer’s total billing units sold
during the applicable calendar quarter
(for all NDCs of the manufacturer
assigned to the billing and payment
code).
(3) Summing all manufacturers’ total
billing units sold during the applicable
calendar quarter for all NDCs of the Part
B rebatable drug assigned to the billing
and payment code.
(4) Dividing the resulting amount
from paragraph (b)(2) of this section by
the resulting amount from paragraph
(b)(3) of this section.
(5) Multiplying the resulting amount
from paragraph (b)(4) of this section by
the total rebate amount as determined
under paragraph (a) of this section.
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§ 427.302 Calculation of the per unit Part B
drug rebate amount.
(a) Formula for calculating the per
unit Part B rebate amount. CMS will
calculate the per unit Part B rebate
amount for a Part B rebatable drug and
applicable calendar quarter by
determining the amount by which the
specified amount, as calculated in
accordance with paragraph (b) of this
section, exceeds the inflation-adjusted
payment amount, as calculated in
accordance with paragraph (g) of this
section.
(b) Identification of the specified
amount for the applicable calendar
quarter. For each applicable calendar
quarter, subject to paragraph (b)(2) of
this section, the specified amount is
equal to the amount determined in
accordance with section
1847A(i)(3)(A)(ii)(I)(aa) or (bb) of the
Act, as applicable, for the calendar
quarter.
(1) The first applicable calendar
quarter for a Part B rebatable drug will
be the earliest applicable calendar
quarter that follows the payment
amount benchmark quarter identified in
paragraphs (c)(1) through (5) of this
section.
(2) If all NDCs in the billing and
payment code have neither
manufacturer-reported ASP nor
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Wholesale Acquisition Cost (WAC)
price data available for the applicable
calendar quarter, CMS will use WAC
price data from other public sources, if
available, to calculate 106 percent of
WAC, which will serve as the specified
amount.
(c) Identification of the payment
amount benchmark quarter. For each
Part B rebatable drug, CMS will identify
the applicable payment amount
benchmark quarter using the earliest
first marketed date of any NDC ever
marketed under any FDA application
under which any NDCs that have ever
been assigned to the billing and
payment code as of the applicable
calendar quarter have been marketed, as
set forth in paragraphs (c)(1) through (3)
of this section, as applicable, subject to
paragraphs (c)(4) and (5) of this section:
(1) For a Part B rebatable drug first
approved or licensed by the FDA on or
before December 1, 2020, and with a
first marketed date on or before
December 1, 2020, the payment amount
benchmark quarter is the calendar
quarter beginning July 1, 2021.
(2) For a Part B rebatable drug first
approved or licensed by the FDA after
December 1, 2020, the payment amount
benchmark quarter is the third full
calendar quarter after a drug’s first
marketed date.
(3) For a Part B rebatable drug first
approved or licensed by the FDA on or
before December 1, 2020, but with a first
marketed date after December 1, 2020,
the payment amount benchmark quarter
is the third full calendar quarter after a
drug’s first marketed date.
(4) Notwithstanding paragraph (c)(3)
of this section, for a Part B rebatable
drug that was billed under a NOC code
during the calendar quarter beginning
July 1, 2021, or the third full calendar
quarter after such drug’s first marketed
date, whichever is later, the payment
amount benchmark quarter is the third
full calendar quarter after the Part B
rebatable drug is assigned a billing and
payment code other than a NOC code.
(5) For a Part B rebatable drug that is
a selected drug (as defined in section
1192(c) of the Act) with respect to a
price applicability period (as defined in
section 1191(b)(2) of the Act), in the
case such Part B rebatable drug is no
longer considered to be a selected drug,
for each applicable quarter beginning
after the price applicability period with
respect to such drug, the payment
amount benchmark quarter is the
calendar quarter beginning January 1 of
the last year during such price
applicability period with respect to such
selected drug.
(d) Identification of the payment
amount in the payment amount
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62235
benchmark quarter. CMS will identify
the payment amount in the payment
amount benchmark quarter using the
published payment limit for the billing
and payment code for the applicable
payment amount benchmark quarter
identified in accordance with paragraph
(c) of this section.
(1) For a Part B rebatable drug, subject
to paragraphs (d)(1)(i) and (ii) of this
section and except as provided in
paragraph (d)(2) of this section, CMS
will identify the payment amount in the
payment amount benchmark quarter
using the published payment limit for
the billing and payment code for the
applicable payment amount benchmark
quarter determined in accordance with
section 1847A of the Act.
(i) If a published payment limit is not
available for the applicable payment
amount benchmark quarter, CMS will
use the lower of 106 percent of
manufacturer-reported ASP or 106
percent of manufacturer-reported WAC.
(ii) If neither a published payment
limit nor manufacturer-reported ASP or
WAC data are available, CMS will use
WAC data from other public sources to
calculate 106 percent of WAC, which,
solely for the purposes of this section,
CMS will consider to be the payment
amount for the payment amount
benchmark quarter.
(2) For a Part B rebatable drug
previously billed under a grouped
billing and payment code during the
payment amount benchmark quarter
and later billed under a unique billing
and payment code, CMS will use the
grouped billing and payment code
payment limit as the payment amount
in the payment amount benchmark
quarter.
(e) Identification of the benchmark
period CPI–U. For each Part B rebatable
drug, CMS will identify the applicable
benchmark period CPI–U at the billing
and payment code level as set forth in
paragraphs (e)(1) and (2) of this section,
subject to paragraphs (e)(3) through (5)
of this section:
(1) For a Part B rebatable drug first
approved or licensed by the FDA on or
before December 1, 2020, and with a
first marketed date on or before
December 1, 2020, the benchmark
period CPI–U is the CPI–U for January
2021.
(2) For a Part B rebatable drug first
approved or licensed by the FDA after
December 1, 2020, the benchmark
period CPI–U is the CPI–U for the first
month of the first full calendar quarter
after a drug’s first marketed date.
(3) Notwithstanding paragraph (e)(2)
of this section, for a Part B rebatable
drug first approved or licensed by FDA
on or before December 1, 2020, and with
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a first marketed date after December 1,
2020, the benchmark period CPI–U is
the CPI–U for the first month of the
third full calendar quarter after a drug’s
first marketed date.
(4) Notwithstanding paragraph (e)(3)
of this section, for a Part B rebatable
drug that was billed under a NOC code
during the calendar quarter beginning
July 1, 2021, or the third full calendar
quarter after such drug’s first marketed
date, whichever is later, the benchmark
period CPI–U is the CPI–U for the first
month of the third full calendar quarter
after the Part B rebatable drug is
assigned a billing and payment code
other than a NOC code.
(5) Notwithstanding paragraph (e)(4)
of this section, for a Part B rebatable
drug that is a selected drug (as defined
in section 1192(c) of the Act) with
respect to a price applicability period
(as defined in section 1191(b)(2) of the
Act), in the case such Part B rebatable
drug is no longer considered to be a
selected drug, the benchmark period
CPI–U is the CPI–U for the July of the
year preceding the last year during such
price applicability period.
(f) Identification of the rebate period
CPI–U. For each Part B rebatable drug by
billing and payment code, CMS will
identify and use the greater of the
benchmark period CPI–U index level or
the CPI–U index level for the first
month of the calendar quarter that is
two calendar quarters before the
applicable calendar quarter in which the
Part B rebatable drug is furnished.
(g) Determination of inflationadjusted payment amount. For each
applicable calendar quarter and for each
Part B rebatable drug by billing and
payment code, CMS will calculate the
inflation-adjusted payment amount by
dividing the rebate period CPI–U by the
benchmark period CPI–U and then
multiplying the quotient by the payment
amount in the payment amount
benchmark quarter, determined in
accordance with paragraph (d) of this
section.
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§ 427.303 Determination of total number of
billing units.
(a) General. For each Part B rebatable
drug, CMS will determine the total
number of billing units of the billing
and payment code subject to a rebate in
the applicable calendar quarter using
final action Medicare fee-for-service
claims for which Medicare payment was
allowed and greater than zero.
(b) Total billing units. Using final
action claims in the Medicare fee-forservice claims repository, at least 3
months after the end of the applicable
calendar quarter, CMS will determine
the total number of billing units for a
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Part B rebatable drug in an applicable
calendar quarter by identifying
separately payable claim lines for such
billing and payment code for dates of
service in that applicable calendar
quarter and excluding the following
billing units in claim lines as
applicable:
(1) Billing units of drugs acquired
through the 340B Program. CMS will
exclude billing units acquired under the
340B Program as identified through—
(i) Separately payable billing units in
claim lines for professional claims with
dates of service during 2023 and 2024
from suppliers that are associated with
covered entities listed by the Health
Resources and Services Administration
(HRSA) 340B Office of Pharmacy Affairs
Information System as participating in
the 340B Program. CMS will use
National Provider Identifiers and/or
Medicare Provider Numbers to identify
these suppliers and the claims
submitted with such identifiers;
(ii) Separately payable billing units in
claim lines for institutional claims that
are billed with the ‘‘JG’’ or ‘‘TB’’
modifiers for claims with dates of
service through December 31, 2024; and
(iii) Separately payable billing units
in claim lines billed with the ‘‘TB’’
modifier for claims with dates of service
on or after January 1, 2025.
(2) Billing units with a rebate under
section 1927 of the Social Security Act.
Subject to paragraph (b)(2)(i) of this
section, CMS will exclude billing units
from claims with dates of service during
a month within an applicable calendar
quarter if the units are furnished to a
dually eligible Medicare beneficiary
who has Medicaid coverage that may
provide cost-sharing assistance.
(i) CMS will not exclude billing units
from claims when the Medicare
beneficiary has Medicaid coverage that
does not include cost-sharing assistance,
including Specified Low-Income
Medicare Beneficiaries (SLMB),
Qualified Disabled and Working
Individuals (QDWI), and Qualifying
Individuals (QI) beneficiaries.
(ii) [Reserved]
(3) Billing units that are packaged
into the payment amount for an item or
service and are not separately payable.
CMS will exclude billing units that are
packaged into the payment amount for
an item or service and are not separately
payable.
(4) Billing units when a drug is no
longer a Part B rebatable drug. In
situations where a Part B rebatable drug
that is a single source drug becomes a
multiple source drug during an
applicable calendar quarter, CMS will:
(i) Determine if such drug has become
a multiple source drug by reviewing
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FDA’s most recent publication of
‘‘Approved Drug Products with
Therapeutic Equivalence Evaluations’’
(commonly known as the Orange Book)
for a drug that is that is rated as
therapeutically equivalent to such drug;
and,
(ii) If a therapeutically equivalent
drug is identified in accordance with
paragraph (b)(4)(i) of this section,
determine if the therapeutically
equivalent drug was sold or marketed
during the applicable calendar quarter;
and
(iii) Exclude billing units of such drug
furnished on and after the first day of
the calendar month in which the
therapeutically equivalent drug was first
sold or marketed during the applicable
calendar quarter.
(5) Billing units subject to discarded
drug refunds. CMS will exclude billing
units of discarded refundable singledose container or single-use package
drugs for which a refund has been paid
in accordance with § 414.940 of this
chapter from the calculation of rebate
amounts. For applicable calendar
quarters beginning on or after January 1,
2024, these billing units will be
excluded as part of the reconciliation
process described at § 427.501(d).
§ 427.304 Adjustments for changes to
billing and payment codes.
(a) Changes in billing unit dose
description. If there has been a change
to the dose description for a Part B
rebatable drug (causing a new billing
and payment code to be assigned), CMS
will calculate a conversion factor based
on the ratio of the billing unit dose
description for the current billing and
payment code to the billing unit dose
description for the prior billing and
payment code. CMS will apply the
conversion factor to the payment
amount in the payment amount
benchmark quarter, as described in
§ 427.302(d), before applying the
percentage by which the rebate period
CPI–U for the calendar quarter exceeds
the benchmark period CPI–U.
(b) Instances when a new billing and
payment code is assigned. If a new
billing and payment code is assigned for
a Part B rebatable drug, CMS will use
the payment amount in the payment
amount benchmark quarter, the
payment amount benchmark quarter,
and the benchmark quarter CPI–U of the
prior billing and payment code to
calculate the per unit Part B rebate
amount under § 427.302.
(c) Documentation. CMS will
maintain a crosswalk reflecting the
changes in billing and payment codes
and dose descriptions as applicable.
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Subpart E—Reducing the Rebate
Amount for Part B Rebatable Drugs in
Shortage and When There Is a Severe
Supply Chain Disruption
§ 427.400
Definitions.
As used in this subpart, the following
definitions apply:
Currently in shortage means that at
least one NDC–10 assigned to the billing
and payment code of a Part B rebatable
drug with the status ‘‘currently in
shortage’’ is on a shortage list
maintained by the FDA under section
506E of the FD&C Act.
Drug shortage or shortage means a
period of time when the demand or
projected demand for the drug within
the United States exceeds the supply of
the drug (see section 506C(h)(2) of the
FD&C Act).
Natural disaster means any natural
catastrophe, including, but not limited
to any of the following: hurricane,
tornado, storm, high water, wind-driven
water, tidal wave, tsunami, earthquake,
volcanic eruption, landslide, mudslide,
snowstorm, or drought, or regardless of
cause, any fire, flood, or explosion.
Other unique or unexpected event
means any exogenous, unpredictable
event outside of a manufacturer’s
control, including, but not limited to, a
geopolitical disruption, pandemic, or
act of terror.
Plasma-derived product means a
licensed biological product that is
derived from human whole blood or
plasma, as indicated on the approved
product labeling.
Severe supply chain disruption means
a change in production or distribution
that is reasonably likely to lead to a
significant reduction in the U.S. supply
of a Part B rebatable biosimilar
biological product by a manufacturer
and significantly affects the ability of
the manufacturer of the biosimilar
biological product to fill orders or meet
expected demand for its product in the
United States for at least 90 days. This
definition does not include
interruptions in manufacturing due to
matters such as routine maintenance,
manufacturing quality issues, or
insignificant changes made in the
manufacturing process for the drug.
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§ 427.401 Reducing the rebate amount for
Part B rebatable drugs currently in
shortage.
(a) General. As required under section
1847A(i)(3)(G)(i) of the Act, CMS will
reduce the total rebate amount
calculated under § 427.301(a), if any is
owed, for a Part B rebatable drug that is
currently in shortage, as defined in
§ 427.400, at any point during the
applicable calendar quarter.
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(b) Calculation of the reduced rebate
amount. (1) For each applicable
calendar quarter beginning on or after
January 1, 2023, the reduced total rebate
amount for a Part B rebatable drug
currently in shortage will be calculated
using the following formula:
Equation 1 to Paragraph (b)(1)
Reduced Total Rebate Amount = the
total rebate amount multiplied by (1
minus applicable percent
reduction) multiplied by
(percentage of time drug was
currently in shortage during the
applicable calendar quarter) added
to the total rebate amount
multiplied by (1 minus percentage
of time drug was currently in
shortage during the applicable
calendar quarter)
(2) For purposes of paragraph (b)(1) of
this section, the applicable percent
reduction is:
(i) For a Part B rebatable drug that is
a plasma-derived product:
(A) 75 percent for the first 4
consecutive applicable calendar
quarters such drug is currently in
shortage.
(B) 50 percent for the second 4
consecutive applicable calendar
quarters such drug is currently in
shortage.
(C) 25 percent for each subsequent
applicable calendar quarter such drug is
currently in shortage.
(ii) For a Part B rebatable drug that is
not a plasma-derived product:
(A) 25 percent for the first 4
consecutive applicable calendar
quarters such drug is currently in
shortage.
(B) 10 percent for the second 4
consecutive applicable calendar
quarters such drug is currently in
shortage.
(C) 2 percent for each subsequent
applicable calendar quarter such drug is
currently in shortage.
(3) For purposes of paragraph (b)(1) of
this section, the percentage of time the
drug is currently in shortage during the
applicable calendar quarter is equal to
the number of days such drug is
currently in shortage in an applicable
calendar quarter, divided by the total
number of days in the applicable
calendar quarter.
(c) Application of reduction. CMS will
apply a reduction of the rebate amount
as determined under paragraph (b) of
this section to all the NDCs under the
relevant billing and payment code.
§ 427.402 Reducing the rebate amount for
certain Part B rebatable drugs when there
is a severe supply chain disruption.
(a) General. As required under section
1847A(i)(3)(G)(ii) of the Act, CMS will
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reduce the total rebate amount
calculated under § 427.301(a), if any is
owed, for a Part B rebatable biosimilar
biological product when CMS
determines there is a severe supply
chain disruption during the applicable
calendar quarter such as that caused by
a natural disaster or other unique or
unexpected event.
(b) Calculation of the reduced rebate
amount—(1) Initial reduction. If CMS
determines the criteria described in
paragraph (c)(4) of this section are met,
then CMS will reduce the total rebate
amount owed by the manufacturer for a
Part B rebatable biosimilar biological
product by 75 percent for the quarter in
which the event occurred and the 3
subsequent applicable calendar
quarters.
(2) Extension of reduction. If CMS
determines a severe supply chain
disruption continues into a fifth
applicable calendar quarter as described
in paragraph (c)(5) of this section, then
CMS will reduce the total rebate amount
owed by the manufacturer for a Part B
rebatable biosimilar biological product
by 75 percent for that fifth quarter and
an additional 3 consecutive applicable
calendar quarters.
(3) Application of reduction. If CMS
determines there is a severe supply
chain disruption for an NDC–11
assigned to a billing and payment code,
CMS will apply any reduction of the
rebate amount as described in
paragraphs (b)(1) and (2) of this section
to all the NDCs under the relevant
billing and payment code.
(4) Limitation on rebate reductions.
CMS will not apply multiple rebate
reductions for the same Part B rebatable
drug and applicable calendar quarter.
(i) If a manufacturer believes there are
multiple events causing severe supply
chain disruptions during the same 4
applicable calendar quarters for the
same Part B rebatable biosimilar
biological product and submits multiple
rebate reduction requests for the same
product, CMS will grant no more than
1 rebate reduction under paragraph
(b)(1) or (2) of this section for that
product for those consecutive applicable
calendar quarters.
(ii) If CMS grants a rebate reduction
request under this section, and the Part
B rebatable biosimilar biological
product subject to the reduction is
currently in shortage during the same
four applicable calendar quarters as the
ones for which the severe supply chain
disruption reduction request was
granted, CMS will reduce the rebate
amount as described in paragraph (b)(1)
of this section and will not grant a
reduction under § 427.401 during those
applicable calendar quarters.
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(iii) If a Part B rebatable biosimilar
biological product that is currently in
shortage experiences a severe supply
chain disruption, CMS will reduce the
rebate amount as described in paragraph
(b)(1) of this section and will not grant
a reduction under § 427.401 during
those applicable calendar quarters.
(c) Eligibility for a rebate reduction—
(1) Eligible drug. Subject to paragraph
(b)(3) of this section, eligibility for a
rebate reduction under this section is
limited to Part B rebatable biosimilar
biological products for which a
manufacturer submits a rebate reduction
request under this section.
(2) Timing. For a natural disaster or
other unique or unexpected event
occurring on or after August 2, 2024,
that the manufacturer believes caused a
severe supply chain disruption, the
manufacturer must submit the rebate
reduction request within 60 calendar
days from the first day that the natural
disaster or other unique or unexpected
event occurred or began in order to
receive consideration for a reduction in
the rebate amount owed in accordance
with paragraph (b)(1) of this section.
(3) Required elements of a rebate
reduction request. To receive
consideration for a reduction in the
rebate amount owed in accordance with
paragraph (b)(1) of this section, the
manufacturer must submit to CMS
information and supporting
documentation to substantiate the
evaluation criteria described in
paragraph (c)(4) of this section. Such
information and supporting
documentation include the following:
(i) Evidence that the severe supply
chain disruption directly affects the
manufacturer itself, a supplier of an
ingredient or packaging, a contract
manufacturer, or a method of shipping
or distribution that the manufacturer
uses to make or distribute the Part B
rebatable biosimilar biological
product(s), such as a change in the
production or distribution of the Part B
rebatable biosimilar biological
product(s) that is reasonably likely to
lead to a significant reduction in the
U.S. supply of product and significantly
affects the manufacturer’s ability to fill
orders or meet expected demand for the
Part B rebatable biosimilar biological
product(s) for at least 90 days;
(ii) Information about when the
manufacturer expects supply of the Part
B rebatable biosimilar biological
product(s) to meet expected demand;
(iii) Evidence that the natural disaster
or other unique or unexpected event
caused the severe supply chain
disruption, including when the natural
disaster or other unique or unexpected
event occurred or began occurring, and
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the expected or actual duration of the
severe supply chain disruption; and
(iv) Evidence of the manufacturer’s
physical presence related to
manufacturing the Part B rebatable
biosimilar biological product(s) in a
geographic area where a natural disaster
or other unique or unexpected event
occurred. If the manufacturer is not
physically present in a geographic area
where a natural disaster or other unique
or unexpected event occurred, but
believes there is a severe supply chain
disruption caused by a natural disaster
or other unique or unexpected event
that affects the manufacturer’s Part B
rebatable biosimilar biological
product(s), the information and
supporting documentation may include
evidence of the impact of the natural
disaster or other unique or unexpected
event on the supply chain of the Part B
rebatable drug or biosimilar, on a
supplier of an ingredient or packaging,
or method of shipping or distribution
that the manufacturer uses.
(4) Evaluation criteria. In accordance
with paragraph (b)(1) of this section,
CMS will grant a reduction in the rebate
amount owed if a manufacturer submits
to CMS a request in writing for an
eligible drug, in accordance with the
timing specified in paragraph (c)(2) of
this section, demonstrating that:
(i) A severe supply chain disruption
has occurred during the applicable
calendar quarter;
(ii) The severe supply chain
disruption directly affects the
manufacturer itself, a contract
manufacturer, a supplier of an
ingredient or packaging, or a method of
shipping or distribution that the
manufacturer uses in a significant
capacity to make or distribute the Part
B rebatable biosimilar biological
product; and
(iii) The severe supply chain
disruption was caused by a natural
disaster or other unique or unexpected
event.
(5) Rebate reduction extensions. If
CMS determines that a Part B rebatable
biosimilar biological product that
received a reduction of the rebate
amount under paragraph (b)(1) of this
section continues to be affected by a
severe supply chain disruption, CMS
will grant a single extension of the
reduction for 4 additional consecutive
applicable calendar quarters and reduce
the rebate amount owed in accordance
with paragraph (b)(2) of this section.
(i) To receive consideration for a
rebate reduction extension, a
manufacturer must submit a request
with updated or new information and
supporting documentation on why the
Part B rebatable biosimilar biological
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product continues to be affected by the
severe supply chain disruption during
the fifth through eighth applicable
calendar quarters.
(ii) A manufacturer must submit the
rebate reduction extension request at
least 60 calendar days before the start of
the fifth applicable calendar quarter to
receive consideration for a reduction in
the rebate amount owed, if any, in
accordance with paragraph (b)(2) of this
section.
(6) Decision to grant or deny a
request. CMS will review rebate
reduction requests and rebate reduction
extension requests within 60 calendar
days of receipt of all documentation, if
feasible, beginning with the applicable
calendar quarter that begins on October
1, 2024.
(i) CMS will deny a rebate reduction
request that does not meet the criteria in
paragraph (c)(4) of this section or that is
incomplete or untimely based on the
requirements of this paragraph (c).
(ii) CMS will deny a rebate reduction
extension request that does not meet the
criteria in paragraph (c)(5) of this
section, that is incomplete or untimely
based on the requirements of paragraph
(c)(5), or if a reduction under paragraph
(b)(1) of this section was not provided
for such biosimilar biological product.
(iii) CMS’ decisions to deny a request
are final and will not be subject to an
appeals process.
(7) Public disclosure of information.
CMS will keep confidential, to the
extent allowable under law, any
requests for a rebate reduction,
including supporting documentation.
Information provided as part of a
request for a rebate reduction that the
submitter indicates is a trade secret or
confidential commercial or financial
information will be protected from
disclosure if CMS determines the
information meets the requirements set
forth under Exemptions 3 and/or 4 in 5
U.S.C. 552.
Subpart F—Reports of Rebate
Amounts, Reconciliation, Suggestion
of Error, and Payments
§ 427.500
Definitions.
As used in this subpart, date of
receipt is the calendar day following the
day on which a report of a rebate
amount (as set forth in §§ 427.501(b)
through (d) and 427.502(c)) is made
available to the manufacturer of a Part
B rebatable drug by CMS.
§ 427.501 Rebate Reports and
reconciliation.
(a) General. This section applies to
Part B rebatable drugs for all applicable
calendar quarters except as otherwise
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set forth in § 427.502 regarding the
applicable calendar quarters in calendar
years 2023 and 2024.
(b) Preliminary Rebate Report. A
Preliminary Rebate Report will be
provided to each manufacturer of a Part
B rebatable drug at least 1 month prior
to the issuance of the Rebate Report as
set forth in paragraph (c) of this section
for an applicable calendar quarter.
(1) The Preliminary Rebate Report for
each Part B rebatable drug will include
the following information:
(i) The NDC(s) and billing and
payment codes for the Part B rebatable
drug as defined under § 427.20.
(ii) Total number of billing units as
specified in § 427.303.
(iii) Payment amount in the payment
amount benchmark quarter as specified
in § 427.302(d).
(iv) Applicable calendar quarter
specified amount as specified in
§ 427.302(b).
(v) Applicable benchmark period and
rebate period CPI–Us as specified in
§ 427.302(e) and (f).
(vi) Inflation-adjusted payment
amount as specified in § 427.302(g).
(vii) The amount, if any, by which the
specified amount as described in
§ 427.302(b) exceeds the inflationadjusted payment amount as described
in § 427.302(g) for the Part B rebatable
drug for the applicable calendar quarter
as determined under § 427.302.
(viii) Any applied reductions as
described in §§ 427.401 and 427.402.
(ix) Rebate amount due as specified in
§ 427.301(a).
(2) [Reserved]
(c) Rebate Report. A Rebate Report
will be provided to each manufacturer
of a Part B rebatable drug no later than
6 months after the end of each
applicable calendar quarter.
(1) The Rebate Report will include the
information specified in paragraph
(b)(1) of this section, with the inclusion
of any revisions to such information
resulting from CMS’ review of a
Suggestion of Error as set forth in
§ 427.503, if applicable, and any CMSdetermined recalculations from
paragraph (d)(2) of this section.
(2) The Rebate Report is the invoice
of a manufacturer’s rebate amount due
as calculated in § 427.301, if any, for a
Part B rebatable drug for an applicable
calendar quarter.
(d) Reconciliation of the rebate
amount. CMS will perform
reconciliation of a rebate amount
provided in a Rebate Report specified in
paragraph (c) of this section for an
applicable calendar quarter in the
following circumstances:
(1) Regular reconciliation. Except as
otherwise described in § 427.502, CMS
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will perform one regular reconciliation
of the rebate amount within 12 months
of the date of receipt of the Rebate
Report specified in paragraph (c) of this
section for each applicable calendar
quarter in order to include revisions to
the information used to calculate the
rebate amount as specified in paragraph
(b)(1) of this section.
(i) Preliminary reconciliation. At least
1 month prior to the issuance of a report
with the reconciled rebate amount
specified in paragraph (d)(1)(ii) of this
section, CMS will conduct a preliminary
reconciliation of a rebate amount for an
applicable calendar quarter specified in
paragraph (d)(3) of this section based on
the information specified in this
paragraph (b)(1)(i) and paragraphs
(d)(1)(ii) through (ix) of this section and
provide the information specified in this
paragraph (b)(1)(i) and paragraphs
(d)(1)(ii) through (ix) to the
manufacturer of a Part B rebatable drug
for the applicable calendar quarter, if
applicable:
(A) Updated total number of rebatable
units, as specified in § 427.303.
(B) Payment amount in the payment
amount benchmark quarter, as specified
in § 427.302(d) if any inputs are restated
within the reconciliation run-out
period.
(C) Applicable calendar quarter
specified amount as specified in
§ 427.302(b), if any inputs are restated
within the reconciliation run-out
period.
(D) The excess amount by which the
specified amount exceeds the inflationadjusted payment amount as specified
in § 427.302, if any inputs are restated
within the reconciliation run-out
period.
(E) Reconciled total rebate amount as
specified in § 427.301(a).
(F) The difference between the total
rebate amount due as specified on the
Rebate Report set forth in paragraph (c)
of this section and the reconciled rebate
amount as set forth in this paragraph
(d)(1)(i).
(ii) Report with reconciled rebate
amount. With the inclusion of any
additional revisions to such information
resulting from CMS’ review of a
Suggestion of Error as set forth in
§ 427.503, if applicable, a report with
the reconciled rebate amount will be
provided to each manufacturer of a Part
B rebatable drug within 12 months after
the issuance of the Rebate Report
described in paragraph (c) of this
section.
(2) CMS identification of error and
manufacturer misreporting. CMS may
recalculate a rebate amount and provide
the manufacturer of a Part B rebatable
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drug a report with a reconciled rebate
amount when:
(i) CMS identifies an agency error in
the information specified in paragraphs
(c) and (d)(1) of this section, including
reporting system or coding errors, not
later than 3 years from the date of
receipt by a manufacturer of a
reconciled rebate amount for the
applicable calendar quarter; or
(ii) CMS determines at any time that
the information used by CMS to
calculate the rebate amount was
inaccurate due to manufacturer
misreporting.
(3) Impact of reconciliation on rebate
amount. A reconciliation as set forth in
this paragraph (d) could result in an
increase, decrease, or no change to the
rebate amount as calculated in § 427.301
owed by a manufacturer for the
applicable calendar quarter for the Part
B rebatable drug.
(i) A report with a reconciled rebate
amount that is an increase to the rebate
amount is the invoice for such
additional amount due on the
manufacturer’s rebate amount as set
forth in § 427.301 for a Part B rebatable
drug for an applicable calendar quarter.
(ii) [Reserved]
(4) Drugs included in a reconciliation.
A drug covered under Part B that does
not meet the requirements of a rebatable
drug specified in subpart B for an
applicable period will not be included
in a reconciliation under this paragraph
(d).
§ 427.502 Rebate Reports for applicable
calendar quarters in calendar years 2023
and 2024.
(a) Transition rule for reporting.
Section 1847A(i)(1)(C) of the Act allows
CMS to delay the timeframe for
reporting the information and rebate
amount described in § 427.501(c) for
applicable calendar quarters in calendar
years 2023 and 2024 until not later than
September 30, 2025.
(b) Rebate Report information for
applicable calendar quarters in
calendar years 2023 and 2024. The
Rebate Reports for applicable calendar
quarters in calendar years 2023 and
2024 will include the information
described in § 427.501(b)(1).
(c) Rebate Report procedures for
applicable calendar quarters in
calendar years 2023 and 2024. Rebate
amounts for the applicable calendar
quarters in calendar year 2023 and 2024
will be reported as follows:
(1) The four applicable calendar
quarters in calendar year 2023 will be
consolidated into a single report and
manufacturers will receive a single
Preliminary Rebate Report followed by
a single Rebate Report.
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(i) Discarded drug units for which a
refund has been paid will be removed
from the total number of billing units in
the single Preliminary Rebate Report for
the applicable calendar quarters in
calendar year 2023.
(ii) For this single Preliminary Rebate
Report for the applicable calendar
quarters in calendar year 2023, the
Suggestion of Error period as described
in § 427.503 will be 30 calendar days.
(iii) No regular reconciliation of the
rebate amount as described in
§ 427.501(d)(1) will be conducted for the
rebate amount in the single Rebate
Report for the applicable calendar
quarters in calendar year 2023.
(2) The four applicable calendar
quarters in calendar year 2024 will be
consolidated into a single report and
manufacturers will receive a single
Preliminary Rebate Report followed by
a single Rebate Report.
(i) For this single Preliminary Rebate
Report for the applicable calendar
quarters in calendar year 2024, the
Suggestion of Error period as described
in § 427.503 will be 30 calendar days.
(ii) Nine months after issuance of the
single Rebate Report, CMS will perform
one regular reconciliation for the
applicable calendar quarters in calendar
year 2024 in order to include revisions
to the information used, specified in
§ 427.501(b)(1), to calculate the rebate
amount. Such reconciliation will be as
described in § 427.501(d) inclusive of a
preliminary reconciliation and a report
with the reconciled rebate amount.
(iii) The Suggestion of Error period for
the preliminary reconciliation for the
applicable calendar quarters in calendar
year 2024 will be 10 calendar days.
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§ 427.503
Suggestion of Error.
(a) General. The manufacturer of a
Part B rebatable drug may submit a
Suggestion of Error about the
information in their Preliminary Rebate
Report and the report detailing the
preliminary reconciliation of the rebate
amount to CMS, for its discretionary
consideration, if the manufacturer
believes that there is a mathematical
error or errors to be corrected before the
Rebate Report or a subsequent
reconciliation of the rebate amount, as
applicable, is finalized.
(1) Section 1847A(i)(8) of the Act
precludes administrative or judicial
review on the determination of units as
set forth in § 427.303, the determination
of whether a drug is a Part B rebatable
drug as set forth in§ 427.101, and the
calculation of the rebate amount as set
forth in § 427.301, inclusive of any
reconciled rebate amount.
(2) [Reserved]
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(b) Process of submission. Subject to
the scope and timing requirements
specified in paragraphs (a) and (c) of
this section, manufacturers may submit
the Suggestion of Error and provide
supporting documentation (if
applicable).
(c) Timing. Except as specified in
§ 427.502 for applicable calendar
quarters in calendar year 2023 and 2024,
a manufacturer must submit its
Suggestion of Error for the applicable
calendar quarter within 10 calendar
days from the date of receipt of a
Preliminary Rebate Report or a
preliminary reconciliation of a rebate
amount using the method and process
established by CMS in paragraph (b) of
this section.
(d) Notice. (1) CMS will include any
revisions to the calculation of the rebate
amount, if determined necessary by
CMS based on the Suggestion of Error
submitted under this section prior to
issuance of the Rebate Report as set
forth in § 427.501(c) or § 427.502(c) as
well as any report of reconciled rebate
amount as set forth in § 427.501(d) or
§ 427.502(c)(2)(ii).
(2) CMS will notify the manufacturer
whether CMS revised its calculation of
the rebate amount based on the
Suggestion of Error.
§ 427.504
Reports.
Manufacturer access to Rebate
(a) General. CMS will establish a
method and process for a manufacturer
of the Part B rebatable drug to:
(1) Access the manufacturer’s Rebate
Report as set forth in §§ 427.501 and
427.502, including any report of
reconciled rebate amount as set forth in
§§ 427.501(d) and 427.502(c)(2)(ii);
(2) Submit a Suggestion of Error as set
forth in §§ 427.502(c)(1)(ii) and (c)(2)(i)
and 427.503; and
(3) Pay a rebate amount as set forth in
§ 427.505.
(b) [Reserved]
§ 427.505 Deadline and process for
payment of rebate amount.
(a) Rebate amounts owed by a
manufacturer. For a rebate amount
owed by a manufacturer, payment is
due no later than 11:59 p.m. Pacific
Time (PT) on the 30th calendar day after
the date of receipt of information
regarding the rebate amount on—
(1) A Rebate Report specified in
§ 427.501(c) or § 427.502(c)(1) or (2); or
(2) A report of a reconciled rebate
amount specified in § 427.501(d) or
§ 427.502(c)(2)(ii).
(b) Failure to pay a rebate amount.
Failure to pay a rebate amount due
timely and in full may result in an
enforcement action as described in
subpart G of this part.
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(c) Refund to the manufacturer. If a
reconciled rebate amount for an
applicable calendar quarter as specified
in § 427.501(d) or § 427.502(c)(2)(ii) is
less than what the manufacturer paid for
that applicable calendar quarter, CMS
will initiate the process to provide a
refund equal to the excess amount paid
within 60 days of the date of receipt of
the report with such reconciled rebate
amount.
Subpart G—Enforcement of
Manufacturer Payment of Rebate
Amounts
§ 427.600 Civil money penalty notice and
appeals procedures.
(a) General. CMS may impose a civil
money penalty on a manufacturer that
fails to pay the rebate amount set forth
in § 427.301(a) on a Part B rebatable
drug identified at § 427.101, by the
payment deadline as set forth in
§ 427.505(a) for such drug for such
applicable calendar quarter.
(b) Determination of the civil money
penalty amount. CMS may impose a
civil money penalty for each failure by
a manufacturer to provide an inflation
rebate for an applicable calendar quarter
equal to 125 percent of the rebate
amount determined in § 427.301(a).
(1) The civil money penalty is in
addition to the rebate amount due.
(2) If a reconciled rebate amount as set
forth in § 427.501(d) or
§ 427.502(c)(2)(ii) results in an increase
to the rebate amount due, a separate
civil money penalty may be imposed for
the failure by a manufacturer to provide
an inflation rebate for the applicable
quarter for the increase to the rebate
amount due.
(c) Notice of imposition of civil money
penalties. If CMS makes a determination
to impose a civil money penalty
described in paragraph (b) of this
section, CMS will send a written notice
of its decision to impose a civil money
penalty to include the following:
(1) A description of the basis for the
determination.
(2) The basis for the penalty.
(3) The amount of the penalty.
(4) The date the penalty is due.
(5) The manufacturer’s right to a
hearing as specified in paragraph (e)(3)
of this section.
(6) Information about where to file the
request for a hearing.
(d) Collection. (1) A manufacturer
must pay the civil money penalty in full
within 60 calendar days after the date of
the notice of imposition of a civil money
penalty from CMS under paragraph (c)
of this section.
(2) In the event a manufacturer
requests a hearing, pursuant to 42 CFR
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part 423, subpart T, the manufacturer
must pay the amount in full within 60
calendar days after the date of a final
decision by the Departmental Appeal
Board, to uphold, in whole or in part,
the civil money penalty.
(3) If the 60th calendar day described
in paragraphs (d)(1) and (2) of this
section is a weekend or a Federal
holiday, then the timeframe is extended
until the end of the next business day.
(e) Appeal procedures for civil money
penalties. Section 1128A(c)(2) of the Act
provides that CMS may not collect a
civil money penalty until the affected
party has had notice and the
opportunity for a hearing.
(1) Manufacturers may appeal the
following determinations:
(i) A CMS determination that the
rebate amount was not paid by the
applicable payment deadline as
described in § 427.505.
(ii) The calculation of the amount of
the civil money penalty.
(2) The notice provided to a
manufacturer if CMS decides to impose
a civil money penalty is paragraph (c) of
this section.
(3) A manufacturer has a right to a
hearing following a decision by CMS to
impose a civil money penalty following
the administrative appeal process and
procedures established in 42 CFR part
423, subpart T.
(f) Other applicable provisions. The
provisions of section 1128A of the Act
(except subsections (a) and (b) of section
1128A of the Act) apply to civil money
penalties under this section to the same
extent that they apply to a civil money
penalty or procedures under section
1128A of the Act.
(g) Bankruptcy. In the event that a
manufacturer declares bankruptcy, as
described in title 11 of the United States
Code, and as a result of the bankruptcy,
fails to pay either the full rebate amount
owed or the total sum of civil money
penalties imposed, the Government
reserves the right to file a proof of claim
with the bankruptcy court to recover the
unpaid amount of the rebates and civil
money penalties owed by the
manufacturer.
■ 81. Part 428 is added to read as
follows:
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PART 428—MEDICARE PART D DRUG
INFLATION REBATE PROGRAM
Subpart A—General Provisions
Sec.
428.10 Basis and scope.
428.20 Definitions.
Subpart B—Determination of Part D
Rebatable Drugs
428.100 Definitions.
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428.101 Identification of Part D rebatable
drugs.
Subpart C—Determination of the Rebate
Amount for Part D Rebatable Drugs
428.200 Definitions.
428.201 Calculation of the total rebate
amount to be paid by manufacturers.
428.202 Calculation of the per unit Part D
drug rebate amount.
428.203 Determination of the total number
of units dispensed under Part D.
428.204 Treatment of new formulations of
Part D rebatable drugs.
Subpart D—Reducing the Rebate Amount
for Part D Rebatable Drugs in Shortage and
When There is a Severe Supply Chain
Disruption or Likely Shortage
428.300 Definitions.
428.301 Reducing the rebate amount for
Part D rebatable drugs currently in
shortage.
428.302 Reducing the rebate amount for
certain Part D rebatable drugs when there
is a severe supply chain disruption.
428.303 Reducing the rebate amount for
generic Part D rebatable drugs likely to
be in shortage.
Subpart E—Reports of Rebate Amounts,
Reconciliation, Suggestion of Error, and
Payments
428.400 Definitions.
428.401 Rebate Reports and reconciliation.
428.402 Rebate Reports for applicable
periods beginning October 1, 2022, and
October 1, 2023.
428.403 Suggestion of Error.
428.404 Manufacturer access to Rebate
Reports.
428.405 Deadline and process for payment
of rebate amount.
Subpart F—Enforcement of Manufacturer
Payment of Rebate Amounts
428.500 Civil money penalty notice and
appeals procedures.
Authority: 42 U.S.C. 1395w–114b, 1302,
and 1395hh.
Subpart A—General Provisions
§ 428.10
Basis and scope.
(a) Basis. This part implements
section 1860D–14B of the Social
Security Act (‘‘the Act’’).
(b) Scope. This part sets forth the
requirements of the Medicare Part D
Drug Inflation Rebate Program, which
requires, for each 12-month applicable
period, manufacturers to pay rebates for
certain drugs and biological products
with prices that increase faster than the
rate of inflation.
(c) Severability. Were any provision of
this part to be held invalid or
unenforceable by its terms, or as applied
to any person or circumstance, such
provisions would be severable from this
part and the invalidity or
unenforceability would not affect the
remainder thereof or any other part of
this subchapter or the application of
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such provision to other persons not
similarly situated or to other, dissimilar
circumstances.
§ 428.20
Definitions.
As used in this part, the following
definitions apply:
Annual manufacturer price (AnMP)
refers to the amount calculated in
§ 428.202(b).
Applicable period means a 12-month
period beginning with October 1 of a
year (beginning with October 1, 2022).
Applicable period Consumer Price
Index for All Urban Consumers (CPI–U)
means, with respect to an applicable
period, the CPI–U for the first month of
such applicable period (that is,
October).
Applicable threshold means the
amount calculated in accordance with
§ 428.101(b)(2).
Average manufacturer price (AMP)
means the average price paid to the
manufacturer for the drug by
wholesalers for drugs distributed to
retail community pharmacies and retail
community pharmacies that purchase
drugs directly from the manufacturer,
calculated in accordance with § 447.504
of this chapter.
Benchmark period CPI–U means the
CPI–U identified in § 428.202(e).
Benchmark period manufacturer price
refers to the amount calculated in
§ 428.202(d).
Covered Part D Drug has the meaning
set forth in section 1860D–2(e) of the
Act and § 423.100 of this chapter.
CPI–U means the monthly Consumer
Price Index for All Urban Consumers
(United States city average) index level
for all items from the Bureau of Labor
Statistics.
First marketed date means the date
that a manufacturer is required to report
for a Part D rebatable drug as its ‘‘market
date’’ under section 1927(b)(3)(A)(v) of
the Act.
Inflation-adjusted payment amount
means the amount calculated in
§ 428.202(f).
Manufacturer has the meaning set
forth in section 1927(k)(5) of the Act.
National Drug Code (NDC) means the
unique identifying prescription drug
product number that is listed with FDA
identifying the product and package size
and type.
Part D rebatable drug means, subject
to the exclusion described in
§ 428.101(b), a drug or biological that is
a covered Part D drug that, as of the first
day of the applicable period, is:
(1) A drug approved under a New
Drug Application (NDA) under section
505(c) of the Federal Food, Drug, and
Cosmetic (FD&C) Act;
(2) A generic drug approved under an
Abbreviated New Drug Application
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(ANDA) under section 505(j) of the
FD&C Act (‘‘section 505(j) ANDA’’), in
the case where:
(i) The reference listed drug approved
under an NDA under section 505(c) of
the FD&C Act, including any authorized
generic drug as defined in section
505(t)(3) of the FD&C Act, is not being
marketed, as identified in the Food and
Drug Administration’s (FDA) NDC
Directory;
(ii) There is no other drug approved
under section 505(j) of the FD&C Act
that is rated as therapeutically
equivalent in FDA’s most recent
publication of ‘‘Approved Drug
Products with Therapeutic Equivalence
Evaluations’’ (commonly known as the
Orange Book), and that is being
marketed, as identified in FDA’s NDC
Directory;
(iii) The manufacturer is not a ‘‘first
applicant’’ during the ‘‘180-day
exclusivity period,’’ as those terms are
defined in section 505(j)(5)(B)(iv) of the
FD&C Act; and
(iv) The manufacturer is not a ‘‘first
approved applicant’’ for a competitive
generic therapy, as that term is defined
in section 505(j)(5)(B)(v) of the FD&C
Act; or
(3) A biological licensed under
section 351 of the Public Health Service
(PHS) Act, including a biosimilar.
Payment amount benchmark period
means the period identified in
§ 428.202(c).
Subsequently approved drug means a
Part D rebatable drug first approved or
licensed by the FDA after October 1,
2021.
Unit means, with respect to a Part D
rebatable drug, the lowest dispensable
amount (such as a capsule or tablet,
milligram of molecules, or grams) of the
Part D rebatable drug, as reported under
section 1927 of the Act.
Subpart B—Determination of Part D
Rebatable Drugs
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§ 428.100
Definitions.
As used in this subpart, the following
definitions apply:
Individual who uses such a drug or
biological means a unique Medicare Part
D beneficiary who was dispensed the
Part D drug or biological that was
covered by their Part D plan sponsor
during the applicable period, identified
using Prescription Drug Event (PDE)
data with dates of service during the
applicable period and with gross
covered prescription drug costs greater
than zero.
Gross covered prescription drug costs
has the meaning set forth in § 423.308
of this chapter.
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§ 428.101
drugs.
Identification of Part D rebatable
(a) Determination of Part D rebatable
drugs. (1) For each applicable period,
CMS will use PDE data to identify all
covered Part D drugs.
(2) CMS will match the covered Part
D drugs identified in the PDE data with
application numbers using FDA sources
to determine whether each covered Part
D drug is a drug or biological approved
under an NDA under section 505(c) of
the FD&C Act, approved under an
ANDA under section 505(j) of the FD&C
Act, or licensed under a Biologics
License Application (BLA) under
section 351 of the PHS Act, as of the
first day of the applicable period.
(3) For a covered Part D drug
identified in the PDE that is approved
under an ANDA under section 505(j) of
the FD&C Act, CMS will determine
whether such drug meets the criteria in
section 1860D–14B(g)(1)(C)(ii) of the Act
as of the first day of the applicable
period as follows:
(i) To determine whether the
reference listed drug or an authorized
generic of the reference listed drug is
being marketed, as required under
section 1860D–14B(g)(1)(C)(ii)(I) of the
Act, CMS will use FDA’s NDC
Directory, including historical
information from NDC Directory files
such as discontinued, delisted, and
expired listings, provided by the FDA or
published on the FDA website.
(ii) To determine whether another
drug has been approved under an
ANDA that is therapeutically equivalent
to the Part D rebatable drug identified in
this paragraph (a)(3), CMS will use
FDA’s Orange Book. To determine if this
therapeutically equivalent drug is being
marketed, as required under section
1860D–14B(g)(1)(C)(ii)(II) of the Act,
CMS will use FDA’s NDC Directory,
including historical information from
NDC Directory files, such as
discontinued, delisted, and expired
listings, provided by the FDA or
published on the FDA website.
(iii) To determine whether the
manufacturer of the drug identified in
this paragraph (a)(3) is a first applicant
during the 180-day exclusivity period,
or whether the manufacturer of this
drug is a first approved applicant for a
competitive generic drug therapy, CMS
will refer to publicly available FDA
sources such as the Orange Book and
may consult with FDA for technical
assistance as needed.
(b) Drugs and biologicals with average
annual total cost below the applicable
threshold. For each applicable period,
CMS will identify drugs and biologicals
with average annual total costs under
Part D for such applicable period, per
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individual who uses such drug or
biological, that are below the applicable
threshold in accordance with the steps
described in this paragraph (b). Such
drugs and biologicals are not considered
Part D rebatable drugs and will be
excluded from the identification of Part
D rebatable drugs in paragraph (a) of
this section.
(1) Average annual total cost. For
each drug or biological that is identified
in accordance with paragraph (a) of this
section, CMS will calculate average
annual total costs under Part D per
individual who uses such drug or
biological by dividing the gross covered
prescription drug costs for the drug or
biological by the number of individuals
who use such drug or biological in the
applicable period.
(2) Applicable threshold. CMS will
calculate the applicable threshold for an
applicable period as follows:
(i) For the applicable period
beginning October 1, 2022, the
applicable threshold is equal to $100.
(ii) For the applicable period
beginning October 1, 2023, the
applicable threshold is equal to $100
increased by the percentage increase in
CPI–U for the 12-month period
beginning October 1, 2023.
(iii) For subsequent applicable
periods, the applicable threshold is
equal to the applicable threshold for the
prior applicable period increased by the
percentage increase in the CPI–U for the
12-month period beginning with
October of the previous period.
(iv) If the resulting amount under
paragraph (b)(2)(ii) or (iii) of this section
is not a multiple of $10, CMS will round
that amount to the nearest multiple of
$10.
Subpart C—Determination of the
Rebate Amount for Part D Rebatable
Drugs
§ 428.200
Definitions.
As used in this subpart, the following
definitions apply:
340B Program is the program under
section 340B of the PHS Act.
Line extension has the meaning set
forth in § 447.502 of this chapter.
New formulation has the meaning set
forth in § 447.502 of this chapter.
Oral solid dosage form has the
meaning set forth in § 447.502 of this
chapter.
§ 428.201 Calculation of the total rebate
amount to be paid by manufacturers.
(a) Total rebate. (1) Subject to
paragraph (b) of this section, the total
rebate amount to be paid by a
manufacturer for a Part D rebatable
drug, as identified under § 428.101, for
an applicable period is equal to:
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(i) The product of the per unit Part D
rebate amount of such drug, as
determined under § 428.202(a), and the
total number of units dispensed of such
drug under Part D, as determined under
§ 428.203; or
(ii) In the case of a Part D rebatable
drug that is a line extension of a Part D
rebatable drug that is an oral solid
dosage form, the amount specified in
§ 428.204.
(2) The rebate amount may be reduced
in accordance with subpart D of this
part or adjusted in accordance with
subpart E of this part.
(b) Drugs and biologicals excluded
from Part D rebate calculations. CMS
will exclude from the Part D drug
inflation rebate calculations described
in this subpart—
(1) Drugs and biologicals that meet the
definition of a Part D rebatable drug but
whose manufacturers do not have an
agreement in effect with the HHS
Secretary under section 1927 of the Act
at any point during the applicable
period, as determined by CMS through
consultation with Medicaid Drug Rebate
Program staff and review of the
Medicaid Drug Programs system.
(2) Drugs and biologicals that meet the
definition of a Part D rebatable drug but,
for the entire duration of the applicable
period, are excluded from the definition
of covered outpatient drugs as defined
in section 1927(k)(2)–(4) of the Act and
§ 447.502 of this chapter, as determined
by CMS through consultation with
Medicaid Drug Rebate Program staff and
review of the Medicaid Drug Programs
system.
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§ 428.202 Calculation of the per unit Part D
drug rebate amount.
(a) Formula for calculating the per
unit Part D rebate amount. CMS will
calculate the per unit Part D drug
inflation rebate amount for a Part D
rebatable drug and applicable period by
determining the amount by which the
AnMP for the Part D rebatable drug, as
calculated in accordance with paragraph
(b) of this section, exceeds the inflationadjusted payment amount, as calculated
in accordance with paragraph (f) of this
section.
(b) Calculation of the AnMP for the
applicable period. Subject to paragraph
(g) of this section, CMS will calculate
the AnMP for a Part D rebatable drug
using the AMP reported by a
manufacturer under sections
1927(b)(3)(A)(i) and (ii) of the Act for
each calendar quarter of the applicable
period and units reported by a
manufacturer under section
1927(b)(3)(A)(iv) of the Act for each
month of the applicable period.
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(1) CMS will calculate the AnMP for
a Part D rebatable drug as the sum of the
following:
(i) The product of—
(A) The AMP for the Part D rebatable
drug reported for the calendar quarter
beginning October of the applicable
period; and
(B) The sum of the monthly units
reported for the calendar quarter
beginning October of the applicable
period divided by the sum of the
monthly units reported for the 4
calendar quarters in the applicable
period.
(ii) The product of—
(A) The AMP for the Part D rebatable
drug reported for the calendar quarter
beginning January of the applicable
period; and
(B) The sum of the monthly units
reported for the calendar quarter
beginning January of the applicable
period divided by the sum of the
monthly units reported for the 4
calendar quarters in the applicable
period.
(iii) The product of—
(A) The AMP for the Part D rebatable
drug reported for the calendar quarter
beginning April of the applicable
period; and
(B) The sum of the monthly units
reported for the calendar quarter
beginning April of the applicable period
divided by the sum of the monthly units
reported for the 4 calendar quarters in
the applicable period.
(iv) The product of—
(A) The AMP for the Part D rebatable
drug reported for the calendar quarter
beginning July of the applicable period;
and
(B) The sum of the monthly units
reported for the calendar quarter
beginning July of the applicable period
divided by the sum of the monthly units
reported for the 4 calendar quarters in
the applicable period.
(2) The first applicable period for a
Part D rebatable drug will be the earliest
applicable period that follows the
payment amount benchmark period
identified in paragraphs (c)(1) through
(4) of this section.
(c) Identification of the payment
amount benchmark period. For each
Part D rebatable drug, CMS will identify
the payment amount benchmark period
using the date of FDA approval or
licensure or the first marketed date as
set forth in paragraphs (c)(1) and (2) of
this section, subject to paragraphs (c)(3)
through (5) of this section:
(1) For a Part D rebatable drug first
approved or licensed by the FDA on or
before October 1, 2021, the payment
amount benchmark period is the period
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beginning on January 1, 2021, and
ending on September 30, 2021;
(2) For a subsequently approved drug,
the payment amount benchmark period
is the first calendar year beginning after
the drug’s first marketed date;
(3) Notwithstanding paragraph (c)(2)
of this section, for a Part D rebatable
drug first approved or licensed by the
FDA on or before October 1, 2021, for
which there are no quarters during the
period beginning on January 1, 2021,
and ending on September 30, 2021, for
which AMP has been reported under
section 1927(b)(3) of the Act, the
payment amount benchmark period is
the first calendar year no earlier than
calendar year 2021 in which such drug
has at least 1 quarter of AMP reported;
(4) Notwithstanding paragraph (c)(3)
of this section, for a subsequently
approved drug for which there are no
quarters during the first calendar year
beginning after the drug’s first marketed
date for which AMP has been reported
under section 1927(b)(3) of the Act, the
payment amount benchmark period is
the first calendar year in which such
drug has at least 1 quarter of AMP
reported; and
(5) Notwithstanding paragraph (c)(4)
of this section, for a Part D rebatable
drug that is a selected drug (as defined
in section 1192(c) of the Act) with
respect to a price applicability period
(as defined in section 1191(b)(2) of the
Act), in the case such Part D rebatable
drug is no longer considered to be a
selected drug, for each applicable period
beginning after the price applicability
period with respect to such drug, the
payment amount benchmark period is
the last calendar year of such price
applicability period with respect to such
selected drug.
(d) Calculation of benchmark period
manufacturer price. Subject to
paragraph (g) of this section, CMS will
calculate the benchmark period
manufacturer price for a Part D rebatable
drug using the AMP reported by a
manufacturer under sections
1927(b)(3)(A)(i) and (ii) of the Act for
each calendar quarter of the payment
amount benchmark period and the
monthly units reported by a
manufacturer under section
1927(b)(3)(A)(iv) of the Act during the
payment amount benchmark period.
(1) For a Part D rebatable drug with a
payment amount benchmark period
identified under paragraph (c)(1) of this
section, CMS will calculate the
benchmark period manufacturer price as
the sum of the following:
(i) The product of—
(A) The AMP reported for the
calendar quarter beginning January
2021; and
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(B) The sum of the monthly units
reported for the calendar quarter
beginning January 2021 divided by the
sum of the monthly units reported for
the 3 quarters of the payment amount
benchmark period.
(ii) The product of—
(A) The AMP reported for the
calendar quarter beginning April 2021;
and
(B) The sum of the monthly units
reported for the calendar quarter
beginning April 2021 divided by the
sum of the monthly units reported for
the 3 quarters of the payment amount
benchmark period.
(iii) The product of—
(A) The AMP reported for the
calendar quarter beginning July 2021;
and
(B) The sum of the monthly units
reported for the calendar quarter
beginning July 2021 divided by the sum
of the units reported for the 3 quarters
of the payment amount benchmark
period.
(2) For a Part D rebatable drug with a
payment amount benchmark period
identified under paragraphs (c)(2)
through (5) of this section, CMS will
calculate the benchmark period
manufacturer price as the sum of the
following:
(i) The product of—
(A) The AMP reported for the
calendar quarter beginning January of
the payment amount benchmark period;
and
(B) The sum of the monthly units
reported for the calendar quarter
beginning January of the payment
amount benchmark period divided by
the sum of the monthly units reported
for the 4 quarters of the payment
amount benchmark period.
(ii) The product of—
(A) The AMP reported for the
calendar quarter beginning April of the
payment amount benchmark period;
and
(B) The sum of the monthly units
reported for the calendar quarter
beginning April of the payment amount
benchmark period divided by the sum
of the monthly units reported for the 4
quarters of the payment amount
benchmark period.
(iii) The product of—
(A) The AMP reported for the
calendar quarter beginning July of the
payment amount benchmark period;
and
(B) The sum of the monthly units
reported for the calendar quarter
beginning July of the payment amount
benchmark period divided by the sum
of the monthly units reported for the 4
quarters of the payment amount
benchmark period.
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(iv) The product of—
(A) The AMP reported for the
calendar quarter beginning in October of
the payment amount benchmark period;
and
(B) The sum of the monthly units
reported for the calendar quarter
beginning October of the payment
amount benchmark period divided by
the sum of the monthly units reported
for the 4 quarters of the payment
amount benchmark period.
(e) Identification of the benchmark
period CPI–U. For each Part D rebatable
drug, CMS will identify the benchmark
period CPI–U as set forth in paragraphs
(e)(1) and (2) of this section, subject to
paragraphs (e)(3) through (5) of this
section:
(1) For a Part D rebatable drug first
approved or licensed by the FDA on or
before October 1, 2021, the benchmark
period CPI–U is the CPI–U for January
2021.
(2) For a subsequently approved drug,
the benchmark period CPI–U is the CPI–
U for January of the first calendar year
beginning after a drug’s first marketed
date.
(3) Notwithstanding paragraph (e)(2)
of this section, for a Part D rebatable
drug first approved or licensed by the
FDA on or before October 1, 2021, for
which there are no quarters during the
period beginning on January 1, 2021,
and ending on September 30, 2021, for
which AMP has been reported under
section 1927(b)(3) of the Act, the
benchmark period CPI–U is the CPI–U
for January of the payment amount
benchmark period identified under
paragraph (c)(3) of this section.
(4) Notwithstanding paragraph (e)(3)
of this section, for a subsequently
approved drug for which there are no
quarters during the first calendar year
beginning after the drug’s first marketed
date for which AMP has been reported
under section 1927(b)(3) of the Act, the
benchmark period CPI–U is the CPI–U
for January of the payment amount
benchmark period identified under
paragraph (c)(4) of this section.
(5) Notwithstanding paragraph (e)(5)
of this section, for a drug that is a
selected drug (as defined in section
1192(c) of the Act) with respect to a
price applicability period (as defined in
section 1191(b)(2) of the Act), in the
case such Part D rebatable drug is no
longer considered to be a selected drug,
the benchmark period CPI–U is the CPI–
U for January of the last calendar year
of such price applicability period.
(f) Calculation of inflation-adjusted
payment amount. For an applicable
period for each Part D rebatable drug,
CMS will calculate the inflationadjusted payment amount by dividing
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the applicable period CPI–U by the
benchmark period CPI–U and then
multiplying the quotient by the
benchmark period manufacturer price.
(g) Situations in which manufacturers
do not report units under section
1927(b)(3)(A)(iv) of the Act. For the
purpose of calculating the AnMP in
accordance with paragraph (b) of this
section and the benchmark period
manufacturer price in accordance with
paragraph (d) of this section—
(1) If there is 1 or more quarter(s) in
the payment amount benchmark period
or applicable period for which a
manufacturer has not reported units
under section 1927(b)(3)(A)(iv) of the
Act but has reported AMP under
sections 1927(b)(3)(A)(i) and (ii) of the
Act, CMS will calculate the benchmark
period manufacturer price or AnMP, as
applicable, using data only from
quarter(s) with units. Quarter(s) in the
payment amount benchmark period or
applicable period for which a
manufacturer has not reported units
under section 1927(b)(3)(A)(iv) of the
Act will be excluded from the
calculation.
(2) If there are no quarters of the
payment amount benchmark period or
applicable period for which a
manufacturer has reported units under
section 1927(b)(3)(A)(iv) of the Act, but
the manufacturer but has reported AMP,
under sections 1927(b)(3)(A)(i) and (ii)
of the Act for at least 1 quarter of such
period, CMS will use the average of the
AMP over the calendar quarters of the
payment amount benchmark period or
applicable period for which AMP is
reported to calculate the benchmark
period manufacturer price or AnMP,
respectively.
§ 428.203 Determination of the total
number of units dispensed under Part D.
(a) General. For each Part D rebatable
drug, CMS will determine the total
number of units as follows:
(1) Use of PDE data to determine total
units dispensed. To determine the total
number of units of each Part D rebatable
drug dispensed under Part D and
covered by Part D plan sponsors during
an applicable period, CMS will use the
quantity dispensed reported on the PDE
record for each Part D rebatable drug
with gross covered prescription drug
costs greater than zero.
(2) Crosswalk to AMP units. CMS will
crosswalk the information from the PDE
record to database(s) that includes the
unit type (for example, each, capsule)
for the Part D rebatable drug, matching
on the NDC of the Part D rebatable drug.
If the unit type obtained from such
database does not match the AMP unit
type reported by a manufacturer to the
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Medicaid Drug Programs system, CMS
will convert the total units reported on
the PDE to the AMP units reported.
(b) Removal of certain units. CMS will
exclude certain units from the total
number of units dispensed of a Part D
rebatable drug, with respect to an
applicable period, as follows:
(1) Removal of units when a generic
drug is no longer a Part D rebatable
drug. To determine whether a generic
drug that meets the definition of a Part
D rebatable drug on the first day of an
applicable period ceases to meet such
definition later in the applicable period,
CMS will—
(i) Review FDA’s NDC Directory,
including historical information from
NDC Directory files such as
discontinued, delisted, and expired
listings provided by the FDA or
published on the FDA website to
determine whether the reference listed
drug or an authorized generic of the
reference listed drug is being marketed;
(ii) Review the most recent version of
the downloadable FDA Orange Book to
determine whether another drug has
been approved under a section 505(j)
ANDA that is therapeutically equivalent
to such generic drug. If CMS determines
that FDA has approved such a
therapeutically equivalent drug under a
section 505(j) ANDA, CMS will then:
use the FDA’s NDC Directory, including
historical information from NDC
Directory files such as discontinued,
delisted, and expired listings provided
by the FDA or published on the FDA
website to determine the marketing
status of such therapeutically equivalent
drug and whether, during the applicable
period, the therapeutically equivalent
drug was marketed; and
(iii) Exclude from the total number of
units determined under paragraph (a) of
this section any units dispensed on or
after the first day of the calendar month
that a generic drug no longer meets the
definition of a Part D rebatable drug.
(2) Exclusion of units acquired
through the 340B Program. (i) For the
applicable period beginning October 1,
2025, and subsequent applicable
periods, CMS will exclude from the
total number of units determined under
paragraph (a) of this section units for
which a manufacturer provided a
discount under the 340B Program
(‘‘340B units’’) as follows:
(A) For the applicable period
beginning October 1, 2025, 340B units
will be excluded from the total number
of units dispensed for claims with a date
of service on or after January 1, 2026.
(B) For the applicable period
beginning October 1, 2026, and
applicable periods thereafter, 340B units
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will be excluded from the total number
of units dispensed.
(ii) To determine the total number of
such units for which a manufacturer
provided a discount under the 340B
Program, CMS will use data reflecting
the total number of units of a Part D
rebatable drug for which a discount was
provided under the 340B Program and
that were dispensed during the
applicable period.
§ 428.204 Treatment of new formulations
of Part D rebatable drugs.
In the case of a Part D rebatable drug
that is a line extension of a Part D
rebatable drug that is an oral solid
dosage form, the rebate amount for an
applicable period is equal to the amount
computed under § 428.201(a) for such
new drug or, if greater, the alternative
total rebate amount. CMS will
determine the alternative total rebate
amount for such new formulations
according to the following:
(a) Identification of the initial drug.
The initial drug that CMS will use to
calculate the inflation rebate amount
ratio is the initial drug identified in
accordance with § 447.509(a)(4)(iii)(B)
of this chapter for the last quarter of the
applicable period or, if an initial drug
was not identified in the last quarter,
the initial drug identified for a quarter
most recently in that applicable period.
(b) Calculation of the inflation rebate
amount ratio. The inflation rebate
amount ratio is equal to the per unit Part
D drug inflation rebate amount for the
initial drug, as calculated in
§ 428.202(a), divided by the AnMP for
that initial drug for the applicable
period.
(c) Calculation of the alternative total
rebate amount. The alternative total
rebate amount is equal to the product of
all of the following:
(1) The AnMP for the applicable
period, as calculated in § 428.202(b), of
the Part D rebatable drug that is a line
extension of a Part D rebatable drug that
is an oral solid dosage form.
(2) The inflation rebate amount ratio
as determined in paragraph (b) of this
section.
(3) The total number of units
dispensed under Part D identified in
§ 428.203.
Subpart D—Reducing the Rebate
Amount for Part D Rebatable Drugs in
Shortage and When There Is a Severe
Supply Chain Disruption or Likely
Shortage
§ 428.300
Definitions.
As used in this subpart, the following
definitions apply:
Biosimilar has the meaning set forth
in section 351(i) of the PHS Act.
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Currently in shortage means that at
least one NDC–10 of a Part D rebatable
drug with the status ‘‘currently in
shortage’’ is on a shortage list
maintained by the FDA under section
506E of the FD&C Act.
Drug shortage or shortage means a
period of time when the demand or
projected demand for the drug within
the United States exceeds the supply of
the drug (see section 506C(h)(2) of the
FD&C Act).
Generic Part D rebatable drug means
a generic drug approved under an
ANDA under section 505(j) of the FD&C
Act that meets the sole source criteria
specified in § 428.101(a)(3).
Likely to be in shortage means that a
generic Part D rebatable drug is likely to
be described as currently in shortage
during a subsequent applicable period
without such rebate reduction.
Natural disaster means any natural
catastrophe, including, but not limited
to any of the following: hurricane,
tornado, storm, high water, wind-driven
water, tidal wave, tsunami, earthquake,
volcanic eruption, landslide, mudslide,
snowstorm, or drought, or regardless of
cause, any fire, flood, or explosion.
Other unique or unexpected event
means any exogenous, unpredictable
event outside of a manufacturer’s
control, including, but not limited to, a
geopolitical disruption, pandemic, or
act of terror.
Plasma-derived product means a
licensed biological product that is
derived from human whole blood or
plasma, as indicated on the approved
product labeling.
Severe supply chain disruption means
a change in production or distribution
that is reasonably likely to lead to a
significant reduction in the U.S. supply
of a generic Part D rebatable drug or
biosimilar by a manufacturer and
significantly affects the ability of the
manufacturer of the generic drug or
biosimilar to fill orders or meet
expected demand for its product in the
United States for at least 90 days. This
definition does not include
interruptions in manufacturing due to
matters such as routine maintenance,
manufacturing quality issues, or
insignificant changes made in the
manufacturing process for the drug.
§ 428.301 Reducing the rebate amount for
Part D rebatable drugs currently in
shortage.
(a) General. As required under section
1860D–14B(b)(1)(C)(i) of the Act, CMS
will reduce the total rebate amount
calculated under § 428.201(a), if any is
owed, for a Part D rebatable drug that is
currently in shortage, as defined in
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§ 428.300, at any point during the
applicable period.
(b) Calculation of the reduced rebate
amount. (1) For each applicable period
beginning on or after October 1, 2022,
the reduced rebate amount for a Part D
rebatable drug currently in shortage will
be calculated using the following
formula:
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Equation 1 to Paragraph (b)(1)
Reduced Total Rebate Amount = the
total rebate amount multiplied by (1
minus applicable percent
reduction) multiplied by
(percentage of time drug was
currently in shortage during the
applicable period) added to the
total rebate amount multiplied by (1
minus percentage of time drug was
currently in shortage during the
applicable period)
(2) For purposes of paragraph (b)(1) of
this section, the applicable percent
reduction is:
(i) For a Part D rebatable drug that is
a generic drug or plasma-derived
product:
(A) 75 percent for the first applicable
period such drug is currently in
shortage.
(B) 50 percent for the second
applicable period such drug is currently
in shortage.
(C) 25 percent for each subsequent
period such drug is currently in
shortage.
(ii) For a Part D rebatable drug that is
not a generic drug or plasma-derived
product:
(A) 25 percent for the first applicable
period such drug is currently in
shortage.
(B) 10 percent for the second
applicable period such drug is currently
in shortage.
(C) 2 percent for each subsequent
applicable period such drug is currently
in shortage.
(3) For purposes of paragraph (b)(1) of
this section, the percentage of time the
drug is currently in shortage during the
applicable period is equal to the number
of days such drug is currently in
shortage in an applicable period,
divided by the total number of days in
the applicable period.
(c) Application of reduction. CMS will
apply a reduction of the rebate amount
as determined under paragraph (b) of
this section to the Part D rebatable drug
at the NDC–9 level.
§ 428.302 Reducing the rebate amount for
certain Part D rebatable drugs when there
is a severe supply chain disruption.
(a) General. As required under section
1860D–14B(b)(1)(C)(ii) of the Act, CMS
will reduce the total rebate amount
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calculated under § 428.201(a), if any is
owed, for a generic Part D rebatable drug
or biosimilar when CMS determines
there is a severe supply chain
disruption, as defined in § 428.300,
during the applicable period such as
that caused by a natural disaster or other
unique or unexpected event.
(b) Calculation of the reduced rebate
amount—(1) Initial reduction. If CMS
determines the criteria described in
paragraph (c)(4) of this section are met,
then CMS will reduce the total rebate
amount owed by the manufacturer for a
generic Part D rebatable drug or
biosimilar by 75 percent for an
applicable period.
(2) Extension of reduction. If CMS
determines a severe supply chain
disruption continues into a second
consecutive applicable period as
described in paragraph (c)(5) of this
section, then CMS will reduce the total
rebate amount owed by the
manufacturer for a generic Part D
rebatable drug or biosimilar by 75
percent for that second applicable
period.
(3) Application of reduction. If CMS
determines there is a severe supply
chain disruption for an NDC–11, CMS
will apply any reduction of the rebate
amount as described in paragraphs
(b)(1) and (2) of this section to a Part D
rebatable drug at the NDC–9 level.
(4) Limitation on rebate reductions.
CMS will not apply multiple rebate
reductions for the same Part D rebatable
drug and applicable period.
(i) If a manufacturer believes there are
multiple events causing severe supply
chain disruptions during the same
applicable period for the same generic
Part D rebatable drug or biosimilar and
submits multiple rebate reduction
requests for the same drug or biosimilar,
CMS will grant no more than 1 rebate
reduction under paragraph (b)(1) or (2)
of this section for that product for the
applicable period.
(ii) If CMS grants a rebate reduction
request under this section and the
generic Part D rebatable drug or
biosimilar subject to the reduction is
currently in shortage during the same
applicable period as the one for which
the severe supply chain disruption
reduction request was granted, CMS
will reduce the rebate amount as
described in paragraph (b)(1) of this
section and will not grant a reduction
under § 428.301 during that applicable
period.
(iii) If a generic Part D rebatable drug
or biosimilar that is currently in
shortage experiences a severe supply
chain disruption, CMS will reduce the
rebate amount as described in paragraph
(b)(1) of this section, and will not grant
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a reduction under § 428.301 during that
applicable period.
(c) Eligibility for a rebate reduction—
(1) Eligible drug. Subject to paragraph
(b)(3) of this section, eligibility for a
rebate reduction under this section is
limited to Part D rebatable drugs and
biosimilars for which a manufacturer
submits a rebate reduction request
under this section.
(2) Timing. For a natural disaster or
other unique or unexpected event
occurring on or after August 2, 2024 that
the manufacturer believes caused a
severe supply chain disruption, the
manufacturer must submit the rebate
reduction request within 60 calendar
days from the first day that the natural
disaster or other unique or unexpected
event occurred or began to receive
consideration for a reduction in the
rebate amount owed in accordance with
paragraph (b)(1) of this section.
(3) Required elements of a rebate
reduction request. To receive
consideration for a reduction in the
rebate amount owed in accordance with
paragraph (b)(1) of this section, the
manufacturer must submit to CMS
information and supporting
documentation to substantiate the
evaluation criteria described in
paragraph (c)(4) of this section. Such
information and supporting
documentation include the following:
(i) Evidence that the severe supply
chain disruption directly affects the
manufacturer itself, a supplier of an
ingredient or packaging, a contract
manufacturer, or a method of shipping
or distribution that the manufacturer
uses to make or distribute the generic
Part D rebatable drug(s) or biosimilar(s),
such as a change in the production or
distribution of the generic Part D
rebatable drug(s) or biosimilar(s) that is
reasonably likely to lead to a significant
reduction in the U.S. supply of product
and significantly affects the
manufacturer’s ability to fill orders or
meet expected demand for the generic
Part D rebatable drug(s) or biosimilar(s)
for at least 90 days;
(ii) Information about when the
manufacturer expects supply of the
generic Part D rebatable drug(s) or
biosimilar(s) to meet expected demand;
(iii) Evidence that the natural disaster
or other unique or unexpected event
caused the severe supply chain
disruption, including when the natural
disaster or other unique or unexpected
event occurred or began occurring, and
the expected or actual duration of the
severe supply chain disruption; and
(iv) Evidence of the manufacturer’s
physical presence related to
manufacturing the generic Part D
rebatable drug(s) or biosimilar(s) in a
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geographic area where a natural disaster
or other unique or unexpected event
occurred. If the manufacturer is not
physically present in a geographic area
where a natural disaster or other unique
or unexpected event occurred, but
believes there is a severe supply chain
disruption caused by a natural disaster
or other unique or unexpected event
that affects the manufacturer’s generic
Part D rebatable drug(s) or biosimilar(s),
the information and supporting
documentation may include evidence of
the impact of the natural disaster or
other unique or unexpected event on the
supply chain of the generic Part D
rebatable drug or biosimilar, on a
supplier of an ingredient or packaging,
or method of shipping or distribution
that the manufacturer uses.
(4) Evaluation criteria. In accordance
with paragraph (b)(1) of this section,
CMS will grant a reduction in the rebate
amount owed if a manufacturer submits
to CMS a request in writing for an
eligible drug, in accordance with the
timing specified in paragraph (c)(2) of
this section, demonstrating that:
(i) A severe supply chain disruption
has occurred during the applicable
period;
(ii) The severe supply chain
disruption directly affects the
manufacturer itself, a contract
manufacturer, a supplier of an
ingredient or packaging, or a method of
shipping or distribution that the
manufacturer uses in a significant
capacity to make or distribute the
generic Part D rebatable drug or
biosimilar; and
(iii) The severe supply chain
disruption was caused by a natural
disaster or other unique or unexpected
event.
(5) Rebate reduction extensions. If
CMS determines that a generic Part D
rebatable drug or biosimilar that
received a reduction of the rebate
amount under paragraph (b)(1) of this
section continues to be affected by the
severe supply chain disruption, CMS
will grant a single extension of the
reduction for 1 additional consecutive
applicable period and reduce the rebate
amount owed in accordance with
paragraph (b)(2) of this section.
(i) To receive consideration for a
rebate reduction extension, a
manufacturer must submit a request
with updated or new information and
supporting documentation on why the
generic Part D rebatable drug or
biosimilar continues to be affected by
the severe supply chain disruption
during the second applicable period.
(ii) A manufacturer must submit the
rebate reduction extension request at
least 60 calendar days before the start of
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the second consecutive applicable
period to receive consideration for a
reduction in the rebate amount owed, if
any, in accordance with paragraph (b)(2)
of this section, except for when the
initial request is made less than 60
calendar days before the end of an
applicable period such that the initial
rebate reduction is applied to the next
applicable period rather than the
applicable period in which the event
that caused the severe supply chain
disruption occurred or began. In these
cases, the rebate reduction extension
request must be submitted at least 60
calendar days prior to the end of the
applicable period in which the initial
reduction under paragraph (b)(1) of this
section is applied.
(6) Decision to grant or deny a
request. CMS will review rebate
reduction requests and rebate reduction
extension requests within 60 calendar
days of receipt of all documentation, if
feasible, beginning with the applicable
period that begins on October 1, 2024.
(i) CMS will deny a rebate reduction
request that does not meet the criteria in
paragraph (c)(4) of this section or that is
incomplete or untimely based on the
requirements of this paragraph (c).
(ii) CMS will deny a rebate reduction
extension request that does not meet the
criteria in paragraph (c)(5) of this
section, that is incomplete or untimely
based on the requirements of paragraph
(c)(5) of this section, or if a reduction
under paragraph (b)(1) of this section
was not provided for such generic Part
D rebatable drug or biosimilar.
(iii) CMS’ decisions to deny a request
are final and will not be subject to an
appeals process.
(7) Public disclosure of information.
CMS will keep confidential, to the
extent allowable under law, any
requests for a rebate reduction,
including supporting documentation.
Information provided as part of a
request for a rebate reduction request
that the submitter indicates is a trade
secret or confidential commercial or
financial information will be protected
from disclosure if CMS determines the
information meets the requirements set
forth under Exemption 3 or Exemption
4 in 5 U.S.C. 552.
§ 428.303 Reducing the rebate amount for
generic Part D rebatable drugs likely to be
in shortage.
(a) General. As required under section
1860D–14B(b)(1)(C)(iii) of the Act, CMS
will reduce the total rebate amount
calculated under § 428.201, if any is
owed, for a generic Part D rebatable drug
when CMS determines that the generic
Part D rebatable drug is likely to be in
shortage, as defined in § 428.300.
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(b) Calculation of the reduced rebate
amount—(1) Initial reduction. If CMS
determines the criteria described in
paragraph (c)(4) of this section are met,
then CMS will reduce the total rebate
amount owed by the manufacturer for a
generic Part D rebatable drug by 75
percent for an applicable period.
(2) Extension of reduction. If CMS
determines the generic Part D rebatable
drug is likely to be in shortage in a
second applicable period as described
in paragraph (c)(5) of this section, then
CMS will reduce the total rebate amount
owed by the manufacturer for a generic
Part D rebatable drug by 75 percent for
a second consecutive applicable period.
(3) Application of reduction. If CMS
determines that an NDC–11 is likely to
be in shortage, CMS will apply any
reduction of the rebate amount as
described in paragraphs (b)(1) and (2) of
this section to the generic Part D
rebatable drug at the NDC–9 level.
(4) Limitation on rebate reductions. If
CMS grants a rebate reduction request
under this section, and the generic Part
D rebatable drug subject to the reduction
is currently in shortage during the same
applicable period as the one for which
the request was granted, CMS will
reduce the rebate amount as described
in paragraph (b)(1) of this section and
will not grant a reduction under
§ 428.301 during that applicable period.
(c) Eligibility for a rebate reduction—
(1) Eligible drug. Subject to paragraph
(b)(3) of this section, eligibility for a
rebate reduction under this section is
limited to generic Part D rebatable drugs
for which a manufacturer submits a
rebate reduction request under this
section.
(2) Timing. The manufacturer must
submit the rebate reduction request
before the start of the next applicable
period in which the manufacturer
believes the generic Part D rebatable
drug is likely to be in shortage to receive
consideration for a reduction in the
rebate amount owed in accordance with
paragraph (b)(1) of this section.
(3) Required elements of a rebate
reduction request. To receive
consideration for a reduction in the
rebate amount owed in accordance with
paragraph (b)(1) of this section, the
manufacturer must submit to CMS
information and supporting
documentation to substantiate the
evaluation criteria described in
paragraph (c)(4) of this section. Such
information and supporting
documentation include the following:
(i) Evidence that demonstrates a
generic Part D rebatable drug is likely to
be in shortage, including anticipated
cause(s) of the shortage and information
about why the manufacturer believes
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the generic Part D rebatable drug is
likely to be in shortage; and
(ii) Evidence of the anticipated start
date and duration of the potential drug
shortage, the actions the manufacturer is
taking to avoid the potential drug
shortage, and how the reduction of the
rebate amount would reduce the
likelihood of the drug appearing on an
FDA shortage list.
(4) Evaluation criteria. In accordance
with paragraph (b)(1) of this section,
CMS will grant a reduction in the rebate
amount owed if a manufacturer submits
to CMS a request in writing for an
eligible drug, in accordance with the
timing specified in paragraph (c)(2) of
this section, demonstrating that:
(i) The generic Part D rebatable drug
is likely to be in shortage;
(ii) The manufacturer is taking actions
to avoid the potential drug shortage; and
(iii) The reduction of the rebate
amount would reduce the likelihood of
the drug appearing on an FDA shortage
list.
(5) Rebate reduction extensions. If
CMS determines that a generic Part D
rebatable drug that received a reduction
of the rebate amount under paragraph
(b)(1) of this section continues to be
affected by the potential drug shortage,
CMS will grant a single extension of the
reduction for 1 additional consecutive
applicable period and reduce the rebate
amount owed in accordance with
paragraph (b)(2) of this section.
(i) To receive consideration for a
rebate reduction extension, a
manufacturer must submit a request
with updated or new information and
supporting documentation on why the
generic Part D rebatable drug continues
to be affected by the potential drug
shortage during the second applicable
period.
(ii) A manufacturer must submit the
rebate reduction extension request at
least 60 calendar days before the start of
the second consecutive applicable
period in which the manufacturer
believes the generic Part D rebatable
drug is likely to be in shortage to receive
consideration for a reduction in the
rebate amount owed, if any, in
accordance with paragraph (b)(2) of this
section.
(6) Decision to grant or deny a
request. CMS will review rebate
reduction requests and rebate reduction
extension requests within 60 calendar
days of receipt of all documentation, if
feasible, beginning with the applicable
period that begins on October 1, 2024.
(i) CMS will deny a rebate reduction
request that does not meet the criteria in
paragraph (c)(4) of this section or that is
incomplete or untimely based on the
requirements of this paragraph (c).
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(ii) CMS will deny a rebate reduction
extension request that does not meet the
criteria in paragraph (c)(5) of this
section, that is incomplete or untimely
based on the requirements of paragraph
(c)(5) of this section, or if a reduction
under paragraph (b)(1) of this section
was not provided for such generic Part
D rebatable drug.
(iii) CMS’ decisions to deny a request
are final and will not be subject to an
appeals process.
(7) Public disclosure of information.
CMS will keep confidential, to the
extent allowable under law, any
requests for a rebate reduction,
including supporting documentation.
Information provided as part of a
request for a rebate reduction that the
submitter indicates is a trade secret or
confidential commercial or financial
information will be protected from
disclosure if CMS determines the
information meets the requirements set
forth under Exemption 3 or Exemption
4 in 5 U.S.C. 552.
Subpart E—Reports of Rebate
Amounts, Reconciliation, Suggestion
of Error, and Payments
§ 428.400
Definitions.
For the purposes of this subpart, date
of receipt is the calendar day following
the day in which a report of a rebate
amount (as set forth in §§ 428.401(b),
(c), and (d) and 428.402(b) and (c)) is
made available to the manufacturer of a
Part D rebatable drug by CMS.
§ 428.401 Rebate Reports and
reconciliation.
(a) General. This section applies to
Part D rebatable drugs for all applicable
periods except as otherwise set forth in
§ 428.402 for the applicable periods
beginning October 1, 2022, and October
1, 2023.
(b) Preliminary Rebate Report. A
Preliminary Rebate Report will be
provided to each manufacturer of a Part
D rebatable drug at least 1 month prior
to the issuance of the Rebate Report as
set forth in paragraph (c) of this section
for an applicable period.
(1) The Preliminary Rebate Report for
each Part D rebatable drug will include
the following information:
(i) The NDC(s) for the Part D rebatable
drug as defined under § 428.20;
(ii) The total number of units
dispensed under Part D for the Part D
rebatable drug for the applicable period
as determined under § 428.203;
(iii) The benchmark period
manufacturer price as described in
§ 428.202(d).
(iv) The AnMP for the Part D rebatable
drug for the applicable period as
determined in § 428.202(b);
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(v) The amount, if any, of the excess
AnMP for the Part D rebatable drug for
the applicable period as set forth under
§ 428.202(a);
(vi) The benchmark period and
applicable period CPI-Us as set forth in
§§ 428.202(e) and 428.20, respectively;
(vii) Inflation-adjusted payment
amount as set forth in § 428.202(f);
(viii) Any applied reductions
described in §§ 428.301, 428.302, and
428.303; and
(ix) Rebate amount due as set forth in
§ 428.201(a).
(2) If the Part D rebatable drug is a line
extension, the Preliminary Rebate
Report will also include the following
information described in § 428.204:
(i) The NDC for the initial drug;
(ii) The inflation rebate amount ratio
for the initial drug; and
(iii) The alternative total rebate
amount.
(c) Rebate Report. A Rebate Report
will be provided to each manufacturer
of a Part D rebatable drug no later than
9 months after the end of each
applicable period.
(1) The Rebate Report will include the
information described in paragraphs
(b)(1) and (2) of this section, if
applicable, with the inclusion of any
revisions to such information resulting
from CMS’ review of a Suggestion of
Error as set forth in § 428.403, if
applicable, and any CMS-determined
recalculations from paragraph (d)(2) of
this section.
(2) The Rebate Report is the invoice
of a manufacturer’s rebate amount due
as calculated in § 428.201(a), if any, for
a Part D rebatable drug for an applicable
period.
(d) Reconciliation of the rebate
amount. CMS will perform
reconciliation of the rebate amount
provided in a Rebate Report specified in
paragraph (c) of this section for an
applicable period in the following
circumstances:
(1) Regular reconciliation. Except as
otherwise described in § 428.402, CMS
will perform a reconciliation of the
rebate amount within 12 months of the
date of receipt of the Rebate Report for
an applicable period and a second
reconciliation approximately 24 months
thereafter to include revisions to the
information used to calculate the rebate
amount as specified in paragraph (c)(1)
of this section.
(i) Preliminary reconciliation. At least
1 month prior to the issuance of a report
with the reconciled rebate amount for
an applicable period specified in
paragraph (d)(1)(ii) of this section, CMS
will conduct a preliminary
reconciliation of the rebate amount for
an applicable period based on the
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information specified in paragraphs
(d)(1)(i)(A) through (G) of this section,
and CMS will provide the information
specified in paragraphs (d)(1)(i)(A)
through (G) to the manufacturer of a Part
D rebatable drug for the applicable
period, if applicable:
(A) Updated total number of rebatable
units, including updates submitted by a
prescription drug plan (PDP) or
Medicare Advantage Prescription Drug
(MA–PD) plan sponsor and updates to
340B units (as applicable to the dates of
service and applicable periods specified
in § 428.203(b)(2)(i)(A) and (B)), or units
otherwise excluded as specified in
§ 428.203(b);
(B) Inflation-adjusted payment
amount as specified in § 428.202(f) if
any inputs are restated within the
reconciliation run-out period;
(C) Updated benchmark period
manufacturer price as specified in
§ 428.202(d);
(D) The excess amount by which the
AnMP exceeds the inflation-adjusted
payment amount for the applicable
period as specified in § 428.202(a),
using the most recent AMP (if any
inputs are restated within the
reconciliation run-out period);
(E) Updated data on line extension
calculations, including the initial drug
identified as set forth in
§ 447.509(a)(4)(iii)(B) of this chapter, the
inflation rebate amount ratio, and the
alternative total rebate amount as set
forth in § 428.204 if any inputs are
restated within the reconciliation runout period;
(F) Reconciled rebate amount as
specified in § 428.201(a); and
(G) The difference between the total
rebate amount due as specified on the
Rebate Report set forth in paragraph (c)
of this section and the reconciled rebate
amount as set forth in this paragraph
(d)(1)(i).
(ii) Report with a reconciled rebate
amount. With the inclusion of any
additional revisions to such information
resulting from CMS’ review of a
Suggestion of Error as set forth in
§ 428.403, if applicable, a report with
the reconciled rebate amount will be
provided to each manufacturer of a Part
D rebatable drug within 12 months and
36 months after the issuance of the
Rebate Report described in paragraph (c)
of this section.
(2) CMS identification of an error or
manufacturer misreporting. CMS may
recalculate a rebate amount and provide
the manufacturer of a Part D rebatable
drug a report with a reconciled rebate
amount when:
(i) CMS identifies an error in the
information specified in paragraphs (c)
and (d)(1) of this section, including
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reporting system or coding errors, not
later than 5 years from the date of
receipt by a manufacturer of a
reconciled rebate amount for the
applicable period; or
(ii) CMS determines at any time that
the information used by CMS to
calculate the rebate amount was
inaccurate due to manufacturer
misreporting.
(3) Impact of reconciliation on rebate
amount. A reconciliation as set forth in
this paragraph (d) could result in an
increase, decrease, or no change to the
rebate amount as calculated under
§ 428.201(a) owed by a manufacturer for
the applicable period for the Part D
rebatable drug.
(i) A report with a reconciled rebate
amount that is an increase to the rebate
amount is the invoice for such
additional amount due on the
manufacturer’s rebate amount as set
forth in § 428.201 for a Part D rebatable
drug for an applicable period.
(ii) [Reserved]
(4) Drugs included in a reconciliation.
A drug covered under Part D that does
not meet the requirements of a rebatable
drug specified in § 428.101 for an
applicable period will not be included
in a reconciliation under this paragraph
(d).
§ 428.402 Rebate Reports for applicable
periods beginning October 1, 2022, and
October 1, 2023.
(a) Transition rule for reporting.
Section 1860D–14B(a)(3) of the Act
allows CMS to delay the timeframe for
reporting the information and rebate
amount described in § 428.401 for the
applicable periods beginning October 1,
2022, and October 1, 2023, until not
later than December 31, 2025.
(b) Rebate Report information for
applicable periods beginning October 1,
2022, and October 1, 2023. The Rebate
Reports for the applicable periods
beginning October 1, 2022, and October
1, 2023, will include the information
described in § 428.401(b)(1).
(c) Rebate Report procedures for
applicable periods beginning October 1,
2022, and October 1, 2023. Rebate
amounts for the applicable periods
beginning October 1, 2022, and October
1, 2023, will be reported as follows:
(1) The Rebate Report for the
applicable period beginning October 1,
2022, will be issued no later than
December 31, 2025. The Preliminary
Rebate Report for such applicable
period will be issued at least 1 month
prior to the Rebate Report.
(i) For this single Preliminary Rebate
Report for the applicable period, the
Suggestion of Error period as described
in § 428.403 will be 30 calendar days.
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62249
(ii) The rebate amount will be
reconciled 21 months after the Rebate
Report specified in paragraph (b)(1) of
this section is issued to include the
information specified in
§ 428.401(d)(1)(i)(A) through (G).
(iii) The Suggestion of Error period for
the reconciliation described in
paragraph (b)(1)(ii) of this section will
be 10 calendar days.
(2) The Rebate Report for the
applicable period beginning October 1,
2023, will be issued no later than
December 31, 2025. The Preliminary
Rebate Report for such applicable
period will be issued at least 1 month
prior to the Rebate Report.
(i) For this single Preliminary Rebate
Report for the applicable period, the
Suggestion of Error period as described
in § 428.403 will be 30 calendar days.
(ii) The rebate amount will be
reconciled 9 months after the Rebate
Report and 33 months after the Rebate
Report specified in paragraph (b)(2) of
this section is issued to include the
information specified in
§ 428.401(d)(1)(i)(A) through (G).
§ 428.403
Suggestion of Error.
(a) General. Manufacturers of Part D
rebatable drugs may submit a
Suggestion of Error about the
information in their Preliminary Rebate
Report and the report detailing the
preliminary reconciliation of the rebate
amount to CMS, for its discretionary
consideration, if the manufacturer
believes that there is a mathematical
error or errors to be corrected before the
Rebate Report or a subsequent
reconciliation, as applicable, is
finalized.
(1) Section 1860D–14B(f) of the Act
precludes administrative or judicial
review on the determination of units as
set forth in § 428.203, the determination
of whether a drug is a Part D rebatable
drug as set forth in § 428.101, and the
calculation of the rebate amount as set
forth in § 428.201(a) inclusive of any
reconciled rebate amount.
(2) [Reserved]
(b) Process of submission. Subject to
the scope and timing requirements
specified in paragraphs (a) and (c) of
this section, manufacturers may submit
the Suggestion of Error and provide
supporting documentation (if
applicable).
(c) Timing. Except as specified in
§ 428.402 for the applicable periods
beginning on October 1, 2022, and
October 1, 2023, a manufacturer must
submit its Suggestion of Error for the
applicable period within 10 calendar
days from the date of receipt of a
Preliminary Rebate Report or a
preliminary reconciliation of a rebate
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amount using the method and process
established by CMS in paragraph (b) of
this section.
(d) Notice. (1) CMS will include any
revisions to the calculation of the rebate
amount, if determined necessary by
CMS based on the Suggestion of Error
submitted under this section prior to
issuance of the Rebate Report as set
forth in § 428.401(c) or § 428.402(c) as
well as any report of a reconciled rebate
amount as set forth in § 428.401(d) or
§ 428.402(c)(1)(ii) and (c)(2)(ii).
(2) CMS will notify the manufacturer
whether CMS revised its calculation of
the rebate amount based on the
Suggestion of Error.
§ 428.404
Reports.
Manufacturer access to Rebate
(a) General. CMS will establish a
method and process for a manufacturer
of the Part D rebatable drug to:
(1) Access the Rebate Report as set
forth in §§ 428.401 and 428.402,
including any report of a reconciled
rebate amount as set forth in §§ 428.401
and 428.402;
(2) Submit a Suggestion of Error as set
forth in §§ 428.402(c) and 428.403; and
(3) Pay a rebate amount as set forth in
§ 428.405.
(b) [Reserved]
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§ 428.405 Deadline and process for
payment of rebate amount.
(a) Rebate amounts owed by a
manufacturer. For payment of a rebate
amount owed by a manufacturer:
(1) Upon receipt of a rebate amount,
payment is due no later than 11:59 p.m.
Pacific Time (PT) on the 30 calendar
days after the date of receipt of
information regarding the rebate amount
on—
(i) A Rebate Report specified in
§ 428.401(c) or § 428.402; or
(ii) A report of a reconciled rebate
amount specified in § 428.401(d) or
§ 428.402.
(2) Failure to pay a rebate amount due
timely and in full may result in an
enforcement action as described in
subpart F of this part.
(b) Refund to the manufacturer. If a
reconciled rebate amount for an
applicable period as specified in
§ 428.401(d) or § 428.402 is less than
what the manufacturer paid for that
applicable period, CMS will initiate the
process to provide a refund equal to the
excess amount paid within 60 days of
the date of receipt of the report with
such reconciled rebate amount.
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Subpart F—Enforcement of
Manufacturer Payment of Rebate
Amounts
§ 428.500 Civil money penalty notice and
appeals procedures.
(a) General. CMS may impose a civil
money penalty on a manufacturer that
fails to pay the rebate amount set forth
in § 428.201(a) on a Part D rebatable
drug defined at § 428.20, by the
payment deadline as set forth in section
§ 428.405(a) for such drug for such
applicable period.
(b) Determination of the civil money
penalty amount. CMS may impose a
civil money penalty for each failure by
a manufacturer to provide an applicable
inflation rebate equal to 125 percent of
the rebate amount determined in
§ 428.201(a).
(1) The civil money penalty is in
addition to the rebate amount due.
(2) If a reconciled rebate amount as set
forth in § 428.401(d) or
§ 428.402(c)(1)(ii) or (c)(2)(ii) results in
an increase to the rebate amount due, a
separate civil money penalty may be
imposed for the failure by a
manufacturer to provide an inflation
rebate for the applicable period for the
increase to the rebate amount due.
(c) Notice of imposition of civil money
penalties. If CMS makes a determination
to impose a civil money penalty
described in paragraph (b) of this
section, CMS will send a written notice
of its decision to impose a civil money
penalty to include the following:
(1) A description of the basis for the
determination.
(2) The basis for the penalty.
(3) The amount of the penalty.
(4) The date the penalty is due.
(5) The manufacturer’s right to a
hearing as specified in paragraph (e) of
this section.
(6) Information about where to file the
request for a hearing.
(d) Collection. (1) A manufacturer
must pay the civil money penalty in full
within 60 calendar days after the date of
the notice of imposition of a civil money
penalty from CMS under paragraph (c)
of this section.
(2) In the event a manufacturer
requests a hearing, pursuant to 42 CFR
part 423, subpart T, the manufacturer
must pay the amount in full within 60
calendar days after the date of a final
decision by the Departmental Appeal
Board, to uphold, in whole or in part,
the civil money penalty.
(3) If the 60th calendar day described
in paragraphs (d)(1) and (2) of this
section is a weekend or a Federal
holiday, then the timeframe is extended
until the end of the next business day.
(e) Appeal procedures for civil money
penalties. Section 1128A(c)(2) of the Act
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provides that CMS may not collect a
civil money penalty until the affected
party has had notice and the
opportunity for a hearing.
(1) Manufacturers may appeal the
following determinations:
(i) A CMS determination that the
rebate amount was not paid by the
applicable payment deadline as
described in § 428.405.
(ii) The calculation of the amount of
the civil money penalty.
(2) The notice provided to a
manufacturer if CMS decides to impose
a civil money penalty is described in
paragraph (c) of this section.
(3) A manufacturer has a right to a
hearing following a decision by CMS to
impose a civil money penalty following
the administrative appeal process and
procedures established in 42 CFR part
423, subpart T.
(f) Other applicable provisions. The
provisions of section 1128A of the Act
(except subsections (a) and (b) of section
1128A of the Act) apply to civil money
penalties under this section to the same
extent that they apply to a civil money
penalty or procedures under section
1128A of the Act.
(g) Bankruptcy. In the event that a
manufacturer declares bankruptcy, as
described in title 11 of the United States
Code, and as a result of the bankruptcy,
fails to pay either the full rebate amount
owed or the total sum of civil money
penalties imposed, the government
reserves the right to file a proof of claim
with the bankruptcy court to recover the
unpaid amount of the rebates and civil
money penalties owed by the
manufacturer.
PART 491—CERTIFICATION OF
CERTAIN HEALTH FACILITIES
82. The authority citation for part 491
continues to read as follows:
■
Authority: 42 U.S.C. 263a and 1302.
83. Section 491.9 by—
a. Adding paragraphs (a)(2)(i) and (ii);
b. Removing paragraph (c)(2)(ii);
c. Redesignating paragraphs (c)(2)(iii)
through (vi) as paragraphs (c)(2)(ii)
through (v), respectively; and
■ d. Revising newly designated
paragraph (c)(2)(v).
The additions and revisions read as
follows:
■
■
■
■
§ 491.9
Provision of services.
(a) * * *
(2) * * *
(i) The clinic or center must provide
primary care services.
(ii) The clinic is not a rehabilitation
agency or a facility primarily for the
care and treatment of mental diseases.
*
*
*
*
*
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(c) * * *
(2) * * *
(v) Collection of patient specimens for
transmittal to a certified laboratory for
culturing.
*
*
*
*
*
Xavier Becerra,
Secretary, Department of Health and Human
Services.
Note: The following Appendices will not
appear in the Code of Federal Regulations.
Appendix 1: MIPS Quality Measures
Note: Except as otherwise noted in this
proposed rule, previously finalized measures
and specialty measure sets will continue to
apply for the CY 2025 performance period/
2027 MIPS payment year and future years.
Previously finalized measures and specialty
measure sets are in the CY 2017 through CY
2024 PFS final rules: 81 FR 77558 through
77816, 82 FR 53966 through 54174, 83 FR
60097 through 60285, 84 FR 63205 through
63513, 85 FR 85045 through 85369, 86 FR
65687 through 65968, 87 FR 70250 through
70633, and 88 FR 79556 through 79964. In
addition, electronic clinical quality measures
(eCQMs) that are endorsed by a ConsensusBased Entity (CBE) are shown in Table A of
62251
this Appendix as follows: CBE #/eCQM CBE
#.
Table Group A: New MIPS Quality
Measures Proposed for the CY 2025
Performance Period/2027 MIPS
Payment Year and Future Years
Note: In the CY 2024 PFS final rule,
measure Q494: Excessive Radiation Dose or
Inadequate Image Quality for Diagnostic
Computed Tomography (CT) in Adults
(Clinician Level), was finalized with a 1-year
delay to the CY 2025 performance period (88
FR 79556 through 79560) and does not have
a new measure table in this proposed rule.
BILLING CODE P
A.1. Positive PD-Ll Biomarker Expression Test Result Prior to First-Line Immune Checkpoint Inhibitor Therapy
Measure Steward:
Numerator:
Denominator:
Exclusions:
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Measure Tvoe:
Hi!!h Prioritv Measure:
Collection Tvoe:
Measure-Specific Case
Minimum/Performance
Period:
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Description
NIA/NIA
TBD
Percentage of patients, aged 18 years and older, with a diagnosis of metastatic non-small cell lung cancer
(NSCLC) or squamous cell carcinoma of head and neck (HNSCC) on first-line immune checkpoint inhibitor
(ICT) therapy, who had a positive PD-LI biomarker expression test result prior to giving TCT therapy,
Society for lmmunotherapy of Cancer (SITC)
Patients who had a positive PD-LI biomarker expression test result prior to the initiation of first-line immune
checkpoint inhibitor therapy.
Patients aged 18 years and older with a diagnosis of metastatic non-small cell lung cancer (NSCLC) or squamous
cell carcinoma of head and neck (HNSCC) and on first-line immune checkpoint inhibitors without
chemotherapy.
Patients with NSCLC with epidermal growth factor receptor (EGFR) mutations, ALK genomic tumor
aberrations, or other targetable genomic abnormalities with approved first-line targeted therapy, such as NSCLC
with ROS 1 rearrangement, BRAF V600E mutation, NTRK 1/2/3 gene fusion, MET exl4 skipping mutation, and
RET rearrangement.
Process
Yes
MIPS COM Soecifications
N/A for this measure.
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EP31JY24.204
Category
CBE #/
eCQMCBE#:
Quality#:
Description:
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Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
Rationale:
We are proposing this process measure because it addresses timely biomarker testing, which impacts treatment
decisions for patients with a diagnosis of metastatic non-small cell lung cancer or squamous cell carcinoma of the
head and neck. In addition, this measure aligns with CMS priorities of improving patient outcomes and safety,
while promoting efficacy of timely treatment. Appropriate intervention and timeliness of PD-LI biomarker
expression testing prior to initiation of first-line treatment for metastatic non-small cell lung cancer or squamous
cell carcinoma of the head and neck can lead to improvements in mortality and morbidity rates. 1 Untimely
biomarker testing could lend to negative clinical implications or outcomes, including delayed care and treatment
and/or ineffective or incorrect prescribed therapies leading to chemotherapy toxicity, decreased quality of life,
and unnecessary healthcare costs. 2 3
Immunotherapy remains a new realm for oncology and health care clinicians; therefore, opportunities exist to
improve care provided to patients receiving immune checkpoint inhibitor therapy. In 2017, a survey conducted
by the Association of Community Cancer Centers (ACCC) indicated only 24 percent of respondents reported
they had a deep familiarity with checkpoint inhibitors, 32 percent with monoclonal antibody therapy, and only 17
percent with combination treatment regimens. 4
This measure is predicated on two evidence-based clinical guidelines that address the measure's quality actions
of a positive PD-L 1 biomarker expression test prior to giving first-line immune checkpoint inhibitor therapy in
the metastatic non-small cell lung cancer or squamous cell carcinoma of the head and neck population. 5 6 The
measure would enhance compliance with the clinical guidelines by incentivizing clinicians to address timely
biomarker testing, positively influencing treatment decisions and improving patient outcomes.
The Pre-Rulemaking Measure Review (PRMR) Clinician Recommendation Committee conditionally supported
this measure and requested additional testing examining measure performance and feasibility. This measure has
been fully developed and tested at the clinician level with high reliability based upon signal-to-noise scores, and
adequate face validity. As a part of the MERIT submission, the measure developer reported adequate reliability
testing of the individual data elements via Cohen's kappa coefficient, which substantiates the feasibility for
implementation in MIPS. Testing of measure performance indicated a large gap in care for conducting timely
biomarker testing, with an average performance rate of 19.6 percent, which allows significant room for
improvement among clinicians treating this patient population and conducting the biomarker testing for this
measure. This measure is not currently CBE endorsed. Although CBE endorsement is preferred, it is still
recommended this measure be added to MIPS because it is an evidence-based measure, satisfying the
requirement set forth at section 1848(qX2)(DXv) of the Act, stating that any measure selected for inclusion in
MIPS that is not endorsed by a CBE shall have a focus that is evidenced-based. This measure aligns with the
National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines. 7 •
We recognize that not all measures within MIPS are applicable or appropriate for all clinicians due to the nuances
for each clinician specialization, scope of care, or regional location. However, this measure fills a gap in MIPS
quality measures for treatment of patients with non-small cell lung cancer and squamous cell carcinoma of the
head and neck. In addition, it would provide a specialty specific measure for the MIPS Oncology/Hematology
specialty set under Table B.27a of this Appendix. Furthermore, this measure could be added to the Advancing
Cancer Care MVP in the future and would fill a current quality measure inventory gap within the oncologic
clinical topic.
1 Lim, C., Tsao, M. S., Le, L. W., Shepherd, F. A., Feld, R., Burkes, R. L., Liu, G., Kamel-Reid, S., Hwang, D., Tanguay, J.,
da Cunha Santos, G., & Leighl, N. B. (2015). Biomarker Testing and Time to Treatment Decision in Patients with
Advanced Nonsmall-cell Lung Cancer. Annals of Oncology: Official Journal of the European Society for Medical
Oncology, 26(7), 1415-1421. https://doi.org/10.1093/annonc/mdv208.
2 Pai, S., Blaisdell, D., Brodie, R., Carlson, R., Finnes, H., Galioto, M., Jensen, R. E., Valuck, T., Sepulveda, A. R., &
Kaufman, H. L. (2020). Defining Current Gaps in Quality Measures for Cancer lmmunotherapy: Consensus Report
from the Society for lmmunotherapy of Cancer (SITC) 2019 Quality Summit. Journal for lmmunotherapy of
Cancer, 8(1), e000112. https://doi.org/10.1136/jitc-2019-000112.
3 See footnote Lim et al., 2015.
4 Association of Community Cancer Centers (ACCC). (2017-2018). lmmuno-Oncology: Transforming the Delivery of
Cancer Care in the Community [White paper].
https://www. i nformz. net/ACCC/ data/images/Attachments/2017%201O%20Wh ite%20Paper.pdf.
5 Ettinger, D. S., Wood, D. E., Aisner, D. L., Akerley, W., Bauman, J. R., Bharat, A., Bruno, D. S., Chang, J. Y., Chirieac,
L. R., D'Amico, T. A., Decamp, M., Dilling, T. J., Dowell, J., Gettinger, S., Grotz, T. E., Gubens, M.A., Hegde, A.,
Lackner, R. P., Lanuti, M., Lin, J., ... Hughes, M. (2022). Non-Small Cell Lung Cancer, Version 3.2022, NCCN Clinical
Practice Guidelines in Oncology. Journal of the National Comprehensive Cancer Network: JNCCN, 20(5), 497-530.
https://doi.org/10.6004/jnccn.2022.0025.
6 Pfister, D. G., Spencer, S., Adelstein, D., Adkins, D., Anzai, Y., Brizel, D. M., Bruce, J. Y., Busse, P. M., Caudell, J. J.,
Cmelak, A. J., Colevas, A. D., Eisele, D. W., Fenton, M., Foote, R. L., Galloway, T., Gillison, M. L., Haddad, R. I., Hicks,
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20:32 Jul 30, 2024
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Note: Refer to the PRMR Clinician Recommendation Committee Spreadsheet of Final Recommendations to
CMS and HHS at https:l/p4qm.orglsites/defaultlfiles/2024-02/PRMR-Final-MUC-RecommendationSvreadsheet%20%283%29.xlsx.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62253
W. L., Hitchcock, Y. J., Jimeno, A., ... Darlow, S. D. (2020). Head and Neck Cancers, Version 2.2020, NCCN Clinical
Practice Guidelines in Oncology. Journal of the National Comprehensive Cancer Network: JNCCN, 18(7), 873-898.
https://doi.org/10.6004/jnccn.2020.0031.
7 National Comprehensive Cancer Network (2021). NCCN Clinical Practice Guidelines in Oncology: Head and Neck
Cancer. https ://www.nccn.org/professiona Is/physician _gls/pdf/head-and-neck. pdf.
8 National Comprehensive Cancer Network (2021). NCCN Clinical Practice Guidelines in Oncology: Non-Small Cell
Lung Cancer. https://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf.
A.2. Appropriate Germline Testing for Ovarian Cancer Patients
Cate1wrv
CBE #/
eCQMCBE#:
Qnalitv#:
Description:
Measure Steward:
Numerator:
Denominator:
Exclusions:
TBD
Percentage of patients aged 18 and older diagnosed with epithelial ovarian. fallopian tube, or primary peritoneal
cancer who undergo germline testing within 6 months of diagnosis.
American Society of Clinical Oncology
Patients who receive germline genetic testing for BRCAI and BRCA2 (ideally within the context of a multigene
panel) or who have genetic counseling completed within 6 months of diagnosis.
All patients, aged 18 and older, with epithelial ovarian. fallopian tube, or primary peritoneal cancer newly
diagnosed between July 1st of the previous calendar year through June 30th of the current performance period
with two encounters during the performance period.
Patients who have germline BRCA testing completed before diagnosis of epithelial ovarian. fallopian tube, or
primary peritoneal cancer.
Process
No
MIPS CQM Specifications
EP31JY24.207
N/A for this measure
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Measure Type:
Hi2h Prioritv Measure:
Collection Tvpe:
Measure-Specific Case
Minimum/Performance
Period:
Description
NIA/NIA
62254
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
Descriotion
Cate1wrv
Rationale:
We are proposing this process measure because it addresses patients diagnosed with epithelial ovarian, fallopian
tube, or primary peritoneal cancer who undergo germline testing within 6 months of their diagnosis to guide the
most appropriate treatment. In addition, this measure addresses the CMS priority of promoting more personalized
diagnostic, predictive, prognostic, and therapeutic options for the patient. According to the American Cancer
Society, estimates indicate that there will be about 19,680 new cases ofovarian cancer diagnosed and an
estimated 12,740 women will die of the disease, in 2024 in the U.S. 9 "Knowledge about underlying molecular
alterations in ovarian cancer could allow for more personalized diagnostic, predictive, prognostic, and therapeutic
strategies for the patient but also have clinical implications for her family members." 10 Despite current
recommendations for all women diagnosed with ovarian cancer to receive genetic testing, only approximately 30
percent of those women undergo any genetic testing. 11
Germline mutations in BRCA I and BRCA2 have been identified in 13 to 15 percent of women diagnosed with
ovarian cancer, with somatic mutations found in an additional 7 percent of women. The high incidence of these
mutations, in conjunction with the advent of therapy targeting BRCA mutations, warrants testing in all
individuals diagnosed with ovarian cancer. 12 This testing serves multiple purposes, including determination of
appropriate and best treatment recommendations, risk of other cancers, and need for cascade testing of family
members. "Testing for germline mutations should be performed at the time of initial diagnosis. Presence of a
germline mutation in a woman with advanced cancer designates her as eligible for maintenance therapy with a
poly (ADP-ribose) polymerase (PARP) inhibitor (Olaparib) after response to initial chemotherapy." 13
Although the FDA recently approved frontline maintenance therapy for patients independent of mutation status
following the publication of the ASCO evidence-based guidelines, emerging evidence is expected to indicate an
overall survival benefit in ovarian cancer patients with gem1line mutations, based upon prognostic information
from these patients. Germline mutations testing allows for more personalized therapeutic strategies, therefore,
ovarian cancer patients with germline mutations are expected to derive greater benefit from therapy, thereby
increasing the survival rate in this patient population. 14 Additionally, germline testing informs potential clinical
implications for the relatives of ovarian cancer patients with germline mutations who should be offered
individualized genetic risk evaluation, counseling, and genetic testing as reflected in Recommendation 1.5 in the
ASCO germline testing guidelines. 15 Furthermore, NCCN evidence-based guidelines 16 indicate all patients with
histologically confirmed ovarian, fallopian tube, or primary peritoneal cancer should undergo genetic risk
evaluation as well as germline and somatic testing ifnot previously performed due to germline and/or somatic
BRCA l and BRCA2 statuses delineating future options for maintenance therapy.
This measure could be added to the Advancing Cancer Care MVP in the future and would fill a current quality
measure inventory gap within the oncologic clinical topic. In addition, it would provide a specialty specific
measure for the MIPS Oncology/Hematology specialty set under Table B.27a of this Appendix.
The PRMR Clinician Recommendation Committee conditionally supported this measure for rulemaking pending
endorsement of the measure by a CBE. Although CBE endorsement is preferred, it is still recommended this
measure be added to MIPS because it is an evidence-based measure, satisfying the requirement set forth at
section 1848(q)(2)(D)(v) of the Act, stating that any measure selected for inclusion in MIPS that is not endorsed
by a CBE shall have a focus that is evidenced-based. As mentioned above, this measure aligns with ASCO and
NCCN evidence-based clinical guidelines. 17 18
Note: Refer to the PRMR Clinician Recommendation Committee Spreadsheet of Final Recommendations to
CMS and HHS at https:l/p4qm.org/sites/dejault/files/2024-02/PRMR-Final-MUC-RecommendationSvreadsheet%20%283%29.xlsx.
A.3. Patient-Reported Pain Interference Following Chemotherapy among Adults with Breast Cancer
American Cancer Society (ACS). (2024). Key Statistics for Ovarian Cancer.
https ://www .cancer. o rg/ cancer/types/ ovarian-cancer/ a bout/keystatistics. htm I# :~:text=Th e%20Ame rica n%20Ca n cer%20Society%20esti m ates%20fo r%20ova ria n%20ca ncer,About
%2012%2C740%20women%20will%20die%20from%20ovarian%20cancer.
1 Konstantinopoulos, P.A., Norquist, B., Lacchetti, C., Armstrong, D., Grisham, R. N., Goodfellow, P. J., Kohn, E. C.,
Levine, D. A., Liu, J. F., Lu, K. H., Sparacio, D., & Annunziata, C. M. (2020). Germ line and Somatic Tumor Testing in
Epithelial Ovarian Cancer: ASCO Guideline. Journal of Clinical Oncology: Official Journal of the American Society of
Clinical Oncology, 38(11), 1222-1245. https://doi.org/10.1200/JC0.19.02960.
11 See footnote Konstantinopoulos et al., 2020.
12 See footnote Konstantinopoulos et al., 2020.
13 See footnote Konstantinopoulos et al., 2020.
14 See footnote Konstantinopoulos et al., 2020.
15 See footnote Konstantinopoulos et al., 2020.
16 NCCN. (2024). NCCN Guidelines: Detection, Prevention, and Risk Reduction.
https://www .nccn.org/guidelines/category_2.
17 See footnote Konstantinopoulos et al., 2020.
18 See footnote NCCN, 2024.
9
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Hh!h Priority Measure:
Collection Tvoe:
Measure-Specific Case
Minimum/Performance
Period:
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Description
CBE 3718 /N/A
TBD
The PRO-PM will assess pain interference following chemotherapy administered with curative intent to adult
female patients with breast cancer.
Purchaser Business Group on Health
The mean of the patient-level PROMIS Pain Interference scores at the follow-up survev.
Adult patients with stages I-Ill female breast cancer receiving an initial chemotherapy regimen.
• Patients on a therapeutic clinical trial
• Patients with recurrence/disease progression
• Patients who leave the practice during the follow-up period
• Patients who died during the follow-up period
Patient-Reported Outcome-based Performance Measure (PRO-PM)
Yes
MIPS CQM Specifications
NIA for this measure
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Description:
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Rationale:
············································-·Descriotion
We are proposing this measure because it addresses a CMS high priority as a PRO-PM and fills a gap in
providing the patient's experience of care related to breakthrough pain after chemotherapy for breast cancer
lending to performance improvement. Common persistent symptoms following chemotherapy include pain,
fatigue, and detriments to health-related quality of life. Data from this measure would provide insight into the
effectiveness of minimizing the persistent symptoms following treatment(s), thereby driving quality improvement
leading to practice changes and better patient outcomes.
This oncology PRO-PM's conceptual development is grounded in the evidence-based premise that medical
oncologists who provide the highest quality care (including medical and non-medical support services) to patients
receiving curative-intent cytotoxic therapy can reduce longer-tenn symptom burden, thus improving a patient's
transition into the cancer survivorship period. 19 20 21 Additionally, research suggests collecting and using patientreported symptoms during cancer care can improve patient outcomes, such as increased survival, reduced
symptom burden and improved patient experience. 22 23 Using a standardized symptom assessment process would
facilitate appropriate follow-up to ensure patient needs are addressed, while supporting and improving patientprovider communication.
This measure could be added to the Advancing Cancer Care MVP in the future and would fill a current quality
measure inventory gap within the oncologic clinical topic. In addition, it would provide a specialty specific
measure for the MIPS Oncology/Hematology specialty set under Table B.27a of this Appendix. This would be
the first outcome specialty specific oncology measure to address the patient experience of care. There is potential
consideration for adding broader cancer diagnoses, such as colon and lung cancer, to this measure in the future.
The PRMR Clinician Recommendation Committee conditionally supported this measure for rulemaking with the
condition of implementation at the group level. This measure was endorsed by the CBE as CBE 3718. We are
proposing this measure for implementation at the individual clinician level in addition to the group level. As part
of the MERIT submission, testing was completed at the clinician level with a small sample size due to
accessibility to data. However, the measure steward estimated that measure score reliability given an average
sample size of26 would yield a measure score reliability of0.7. The measure was found during the MERIT
submission to be feasible at the clinician level and data element testing was completed showing exact agreement
values between 71.63 to 100 percent, with the lowest sensitivity variable being 'recurrence,' which would
correlate to a small subset of the patient population. The requirements for quality measure scoring include a case
minimum threshold; therefore, we are proposing to allow this measure for group and clinician level
implementation as it is an important concept and meets all testing and development criteria for MIPS quality
measures.
Note: Refer to the PRMR Clinician Recommendation Committee Spreadsheet of Final Recommendations to
CMS and HHS at https://p4qm.orglsites/default/jiles/2024-02/PRMR-Fina/-MUC-RecommendationSvreadsheet%20%283%29.xlsx.
NCCN. (2024). Clinical Practice Guidelines in Oncology, Cancer-Related Fatigue, Version 2.2024.
https ://www.nccn.org/guidelines/gu idel i nes-deta i I?category=3& i d=1424.
20 Smith, T. G., Troeschel, A. N., Castro, K. M., Arora, N. K., Stein, K., Lipscomb, J., Brawley, 0. W., McCabe, R. M.,
Cl auser, S. B., & Ward, E. (2019). Perceptions of Patients With Breast and Colon Cancer of the Management of
Cancer-Related Pain, Fatigue, and Emotional Distress in Community Oncology. Journal of Clinical Oncology: Official
Journal of the American Society of Clinical Oncology, 37(19), 1666-1676. https://doi.org/10.1200/JCO.18.01579.
21 Bubis, L. D., Davis, L., Mahar, A., Barbera, L., Li, Q., Moody, L., Karanicolas, P., Sutradhar, R., & Coburn, N. G.
(2018). Symptom Burden in the First Year After Cancer Diagnosis: An Analysis of Patient-Reported
Outcomes. Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology, 36(11), 11031111. https://doi.org/10.1200/JCO.2017 .76.0876.
22 Basch, E., Deal, A. M., Kris, M. G., Scher, H. I., Hudis, C. A., Sabbatini, P., Rogak, L., Bennett, A. V., Dueck, A. C.,
Atkinson, T. M., Chou, J. F., Dulko, D., Sit, L., Barz, A., Novotny, P., Fruscione, M., Sloan, J. A., & Schrag, D. (2016).
Symptom Monitoring With Patient-Reported Outcomes During Routine Cancer Treatment: A Randomized
Controlled Trial. Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology, 34(6),
557-565. https://doi.org/10.1200/JC0.2015.63.0830.
23 Papageorgiou, L., Le Provost, J.B., Di Palma, M., Langlois, M., Salma, I., Lopes, M., Minvielle, E., Abbas, M., &
Scotte, F. (2024). Supportive Care Needs of Newly Diagnosed Cancer Patients in a Comprehensive Cancer Center:
Identifying Care Profiles and Future Perspectives. Cancers, 16(5), 1017. https://doi.org/10.3390/cancers16051017.
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A.4. Patient-Reported Fatigue Following Chemotherapy among Adults with Breast Cancer
Measure Steward:
Numerator:
Denominator:
Exclusions:
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Measure Tvoe:
Hi!!h Prioritv Measure:
Collection Tvoe:
Measure-Specific Case
Minimum/Performance
Period:
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Description
CBE 3720 !NIA
TBD
The PRO-PM will assess fatigue following chemotherapy administered with curative intent to adult female
patients with breast cancer.
Purchaser Business Group on Health
The mean of the patient-level PROMlS Fatigue scores at the follow-up survey.
Adult patients with stages 1-lll female breast cancer receiving an initial chemotherapy regimen.
• Patients on a therapeutic clinical trial
• Patients with recurrence/disease progression
• Patients who leave the practice during the follow-up period
• Patients who died during the follow-up period
Patient-Reported Outcome-based Performance Measure (PRO-PM)
Yes
MIPS COM Specifications
N/A for this measure
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Qnalitv#:
Description:
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Rationale:
Descriotion
We are proposing this measure because it addresses a CMS high priority as a PRO-PM and fills a gap in
providing the patient reported symptom of fatigue experienced following chemotherapy for breast cancer, lending
to performance improvement. This measure is an important addition to MIPS for those patients diagnosed with
and receiving treatment for breast cancer. Based on a recent study, stakeholder generated recommendations for
performance measures on how adults with cancer feel and function included depression/anxiety, pain, and fatigue
as top priorities. 24
This oncology PRO-PM's conceptual development is grounded in the evidence-based premise that medical
oncologists who provide the highest quality care (including medical and non-medical support services) to patients
receiving curative-intent cytotoxic therapy can reduce longer-term symptom burden, thus improving a patient's
transition into the cancer survivorship period. 25 26 27 Additionally, research suggests collecting and using patientreported symptoms during cancer care can improve patient outcomes, such as increased survival, reduced
symptom burden and improved patient experience." Using a standardized symptom assessment process would
facilitate appropriate follow-up to ensure patient needs are addressed, while supporting and improving patientprovider communication.
Evidence from one study indicated 30 to 50 percent of breast cancer patients reported not discussing, nor
receiving advice or desired help for three common symptoms including pain, fatigue, and emotional distress. 29
Fatigue was the most common symptom reported in the study (74 percent) with many patients reporting they
discussed the symptom (78 percent)."' However, patients who experienced fatigue were least likely to report
receiving the desired help for it (40 percent). 11 Appropriate use of patient-reported outcome measures (PROMs),
which measure cancer symptoms and patients' perceptions of their care, can improve the collection of clinically
actionable data, supporting clinical improvement in the treatment of common symptoms and the overall care of
patients with cancer, ultimately improving their quality oflife. 32
This measure could be added to the Advancing Cancer Care MVP in the future and would fill a current quality
measure inventory gap within the oncologic clinical topic. In addition, it would provide a specialty specific
measure for the MIPS Oncology/Hematology specialty set under Table B.27a of this Appendix. This measure
would address the patient voice/experience of care for those with breast cancer with fatigue experienced
following chemotherapy. There is potential consideration for adding broader cancer diagnoses, such as colon and
lung cancer, to this measure in the future.
The PRMR Clinician Recommendation Committee did not reach consensus for this measure. This measure was
endorsed by the CBE as CBE 3720. While concerns were discussed regarding electronic health record
implementation, patient survey fatigue and low response impact, this measure is an important clinical topic for
oncology clinicians in conjunction with the pain PRO-PM. More specifically, the measure provides a means to
capture the patient voice while driving quality of care and improving patient outcomes. We are proposing this
measure for implementation at the individual clinician level in addition to the group level. Testing was completed
at the clinician level with a small sample size due to accessibility to data. The measure was found during the
MERIT submission process to be feasible at the clinician level and data element testing was completed showing
exact agreement values between 71.63 to 100 percent, with the lowest sensitivity variable being 'recurrence,'
which would correlate to a small subset of the patient population. The requirements for quality measure scoring
include a case minimum threshold; therefore, we are proposing to allow this measure for group and clinician
level implementation as it is an important concept and meets all testing and development criteria for MIPS
quality measures.
Note: Refer to the PRMR Clinician Recommendation Committee Spreadsheet of Final Recommendations to
CMS and HHS at https:l/p4qm.org/sites/default/fi/es/2024-02/PRMR-Final-MUC-RecommendationSpreadsheet%20%283%29.xlsx.
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25
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Smith et al., 2019 in Table A.3 of this Appendix.
Smith et al., 2019 in Table A.3 of this Appendix.
NCCN, 2024 in Table A.3 of this Appendix.
Bubis et al., 2018 in Table A.3 of this Appendix.
Basch et al., 2016 in Table A.3 of this Appendix.
Smith et al., 2019 in Table A.3 of this Appendix.
Smith et al., 2019 in Table A.3 of this Appendix.
Smith et al., 2019 in Table A.3 of this Appendix.
Smith et al., 2019 in Table A.3 of this Appendix.
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See footnote
See footnote
26 See footnote
27 See footnote
28 See footnote
29 See footnote
30 See footnote
31 See footnote
32 See footnote
24
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A.5. Adult COVID-19 Vaccination Status
Description:
Measure Steward:
Numerator:
lotter on DSK11XQN23PROD with PROPOSALS2
Denominator:
Exclusions:
Measure Tvne:
High Priority Measure:
Collection Type:
Measure-Specific Case
Minimum/Performance
Period:
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Description
NIA/NIA
TBD
Percentage of patients aged 18 years and older seen for a visit during the performance period that are up-to-date
on their COVTD-19 vaccinations as defined by Centers for Disease Control and Prevention (CDC)
recommendations on current vaccination.
Centers for Medicare & Medicaid Services
Patients that are up to date on their COVID-19 vaccinations as defined by CDC recommendations on current
vaccination as of the date of the encounter.
All patients aged 18 years and older seen for a visit during the performance period.
Patient received hospice services any time during the performance period.
Process
No
MIPS CQM Specifications
NIA for this measure
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Quality#:
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We are proposing this process measure because it represents an important clinical topic following the recently
ended Public Health Emergency (PHE) for COVTD-19. This process measure represents a CMS high priority
clinical topic and fills a gap in MIPS by addressing COVID-19 vaccination status for all patients and ensuring
clinician vaccination efforts at the point of care (for example, care for wellness and prevention against COVTD19). Widespread vaccination to prevent a severe COVID-19 infection is critically important to stemming the
morbidity and mortality caused by this virus. The CDC reports millions of cases and deaths caused by COVTD19. 33 ln 2020 and 2021, COVID-19 was the third leading cause of death in the U.S., exceeded only by cancer and
heart disease.3 4 The percent of the population reporting receipt of the updated 2023-24 COVTD-19 vaccine is 13.1
percent (95 percent confidence interval: 12.5-13. 7) for children and 22.5 percent (21. 7-22. 7) for adults 18 years
and older, including 41.5 percent (40.2-42.9) among adults age 65 years and older. 35 36 This recent data suggests a
considerable gap in care for patients in the measure population and allows clinicians the opportunity to positively
affect vaccination rates. Additionally, during measure testing, the measure developer found even the 75th
percentile of performance yielded only 58 percent ofa clinician's patient load being vaccinated with one booster.
The measure was initially submitted to the CY 2022 Call for Quality Measures and included on the Measures
under Consideration (MUC) list for review. During the 2022 cycle, the Measure Applications Partnership (MAP)
recommended not to support the measure and requested the measure be revised before resubmitting for
consideration to, among other things, include the most recent CDC recommendations for the numerator and use
the current CDC definition of"up-to-date" for assessment of the quality action for each denominator eligible
patient. These requests were addressed, and the measure was resubmitted to the CY 2023 Call for Quality
Measures. We acknowledge the recommendations for boosters have continued to evolve; however, the quality
action in this measure is aligned with current and potential future recommendations. Since December 2020, there
have been 19 ACIP recommendations relating to COVTD-19 vaccination. On September 12, 2023, ACIP
recommended all persons aged 6 months and older receive an updated COVTD-19 vaccine.3 7 Updated COVTD-19
vaccines are considered the 2023-2024 formula developed by the pharmaceutical and biotechnology companies
Moderna, Ptizer-BioNTech, and Novavax. Because this measure uses the CDC's definition of"up-to-date,"
please refer to the CDC's website 38 to confirm the current definition of"up-to-date."
Based on clinical recommendations and systemic reviews, there is general agreement about the safety and
efficacy of the COVTD-19 vaccine, preventing costly and potentially harmful hospitalizations. 39 40 41 While this
measure does not meet the definition of a fully developed measure as outlined in the Measures Management
System (MMS),4 2 MIPS currently includes several quality measures that assess for vaccine administration, which
have been implemented for multiple years. 43
Rationale:
We request interested parties consider whether the measure is "beyond the measure concept phase of
development and [has] started testing, at a minimum, with strong encouragement and preference for measures
that have completed or are near completion ofreliability and validity testing" when submitting a quality measure
for possible inclusion (83 FR 53636; 84 FR 62954 ). While we take under consideration whether a measure is
fully tested, it is not the only relevant standard for MIPS. Nevertheless, we believe this consideration reinforces
the importance of all clinicians actively addressing vaccination against the COVID-19 virus. According to the
World Health Organization (WHO), getting vaccinated is one of the most important steps an individual can take
to not only to protect oneself, but to help end the pandemic and stop the emergence of new variants. 44
The PRMR Clinician Recommendation Committee did not reach consensus on this measure for rulemaking,
expressing concerns about data collection for vaccines administered through off-site locations (for example,
pharmacies), as well as vaccine hesitancy that may vary across geography, political affiliation, ethnicity, and
income. The committee considered the measure's importance to patients, with emphasis on those at higher risk
for complications from COVID-19. ACIP recommendations support the measure, all of which are evidencebased. 45 This measure is not currently CBE endorsed. Although CBE endorsement is preferred, it is still
recommended this measure be added to MIPS because it is an evidence-based measure, satisfying the
requirement set forth at section 1848(q)(2)(D)(v) of the Act, stating that any measure selected for inclusion in
MIPS that is not endorsed by a CBE shall have a focus that is evidenced-based. The CDC COVID-19
Immunization Schedule, based on ACIP recommendations, can be referenced at the following webpage:
https:/lwww.cdc.gov/vaccines/schedufes/index.htmf. Clinical recommendations are in universal agreement that
COVID-19 vaccines are safe, effective, and may prevent costly and harmful hospitalizations.
We acknowledge this measure may not be selected by all clinicians, but this factor aligns with MIPS allowing for
clinician choice in choosing quality measures that best represent their scope of care. Clinicians are uniquely
positioned to encourage uptake ofCOVID-19 vaccination. As with all quality measures within MIPS, we
continue to monitor all updates to the clinical recommendations and guidelines and address changes as needed
utilizing the current annual revision cycle.
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The MIPS quality measure set includes several vaccine administration quality measures that have been
implemented for several years; however, such measures do not include the COVID-19 vaccination. 46 This
measure could also be considered for potential inclusion in the Primary Care MVP as it would fill a current
quality measure inventory gap within the vaccination clinical topic for primary care settings. This measure, along
with other activities, are a part ofa larger Federal effort to promote and track vaccine uptake. 47 Since vaccine
uptake is partially driven by patients requesting the vaccine followed by clinicians administering it to eligible
patients, the patient/clinician relationship is a vital aspect for ensuring patients are vaccinated. This clinicianlevel measure would provide useful information regarding the success of vaccination efforts at the point of care,
and, again, represents a priority topic to engage clinicians in quality improvements that drive positive health
outcomes for their patients.
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Descriotion
33 CDC. (2024). COVID Data Tracker. Atlanta, GA: U.S. Department of Health and Human Services.
https://covid. cdc. gov/covid-data-tracker.
34 Ahmad, F.B., Cisewski, J.A., Anderson, R.N. (2022). Provisional Mortality Data - United States, 2021. MMWR
Morb Mortal Wkly Rep 71,597-600. https://dx.doi.org/10.15585/mmwr.mm7117e1.
35 CDC. (2024). Vaccination Trends - Children. https://www.cdc.gov/respiratory-viruses/dataresea rch/ dash boa rd/va cci nation-trends-chi Id ren. htm I.
36 CDC. (2024). Vaccination Trends -Adults. https://www.cdc.gov/respiratory-viruses/dataresea rch/ dash boa rd/va cci nation-trends-ad uIts. htm I.
37 Centers for Disease Control and Prevention (CDC). (2023). Use of Updated COVID-19 Vaccines 2023-2024
Formula for Persons Aged ~6 Months: Recommendations of the Advisory Committee on Immunization Practices United States. https://www.cdc.gov/m mwr/vol umes/72/wr/mm 7242el.htm.
38 CDC. (2024). Stay Up to Date with COVID-19 Vaccines. https://www.cdc.gov/coronavirus/2019ncov/vaccines/stay-up-to-date.html.
39 Fitzpatrick, M. C., Moghadas, S. M., Pandey, A., & Galvani, A. P. (2022). Two Years of US COVID-19 Vaccines Have
Prevented Millions of Hospitalizations and Deaths. To the Point (blog), Commonwealth Fund. December 13.
https://doi.org/10.26099/whsf-fp90.
40 Polack, F. P., Thomas, S. J., Kitchin, N., Absalon, J., Gurtman, A., Lockhart, S., Perez, J. L., Perez Marc, G., Moreira,
E. D., Zerbini, C., Bailey, R., Swanson, K. A., Roychoudhury, S., Koury, K., Li, P., Kalina, W. V., Cooper, D., Frenck, R.
W., Jr, Hammitt, L. L., Ti.ireci, 0., ... C4591001 Clinical Trial Group. (2020). Safety and Efficacy of the BNT162b2
mRNA Covid-19 Vaccine. The New England Journal of Medicine, 383(27), 2603-2615.
https://doi.org/10.1056/NEJMoa20345 77.
41 Grana, C., Ghosn, L., Evrenoglou, T., Jarde, A., Minozzi, S., ... & Boutron, I. (2022). Efficacy and Safety of COVID-19
Vaccines. Cochrane Database of Systematic Reviews, 2023(3).
https://www .cochranelibrary.com/cdsr/doi/10.1002/14651858.CD0154 77 /fu II.
42 CMS. (2023). Measure Implementation - Measure Selection. https://mmshub.cms.gov/measurelifecycle/measure-implementation/selection.
43 See 2024 MIPS Quality Measures List: https://qpp-cm-prodcontent.s3.amazonaws.com/uploads/2632/2024%20MIPS%20Quality%20Measures%20List.xlsx.
44 World Health Organization. (2021, July). Vaccine Efficacy, Effectiveness and Protection.
https ://www.who.int/ news-room/feature-stories/ deta i 1/vacci n e-effi cacy-effectiveness-a nd-protecti on.
45 CDC. (2023, December 12). Vaccine Recommendations and Guidelines of the ACIP: COVID-19 ACIP Vaccine
Recommendations. https ://www.cdc.gov/vaccines/hcp/acip-recs/vacc-specific/covid-19. html.
46 See 2024 MIPS Quality Measures List: https://qpp-cm-prodcontent.s3.amazonaws.com/uploads/2632/2024%20MIPS%20Quality%20Measures%20List.xlsx.
47 Department of Health & Human Services. Vaccines Federal Implementation Plan for the United States: 20212025. https://www.hhs.gov/sites/ d efa u lt/fi les/vacci nes-federa I-i m plementatio n-pl an-2021-2025. pdf.
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Note: Refer to the PRMR Clinician Recommendation Committee Spreadsheet of Final Recommendations to
CMS and HHS at https://p4qm.orglsites/default/flles/2024-02/PRMR-Final-MUC-RecommendationSvreadsheet%20%283%29.xlsx.
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A.6. Melanoma: Trackin2 and Evaluation of Recurrence
Measure Steward:
Numerator:
Denominator:
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Minimum/Performance
Period:
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Description
NIA/NIA
TBD
Percentage of patients who had an excisional surgery for melanoma or melanoma in situ with initial American
Joint Committee on Cancer (AJCC) staging of 0, I, or TT, in the past 5 years in which the operating clinician
examines and/or diagnoses the patient for recurrence of melanoma.
American Academy of Dermatology
NUMERATOR CRITERIA 1: Documentation by the clinician who performed the surgery that an exam for
recurrence of melanoma was performed on the patient within the performance period.
NUMERATOR CRITERIA 2: All patients that were diagnosed with a recurrent melanoma in the current
performance period.
DENOMINATOR CRITERIA 1 & 2: All patients that the clinician has performed a type ofexcisional surgery
for melanoma or melanoma in situ in the past 5 vears with an initial AJCC staging of 0, I or TT.
Patients who died during the performance period
Process
Yes
MIPS CQM Specifications
NIA for this measure
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Qualitv #:
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We are proposing this measure because it evaluates the frequency of recurrence for melanoma along with the
type of recurrence after an excisional procedure, in addition to driving communication regarding the recurrence
status of melanoma patients. The measure also addresses a CMS high priority process measure for care
coordination on the clinical topic as miscommunication between the excising clinician and the clinician
continuing care has been identified as a gap. This measure allows for and promotes the development of a system
in which melanomas can be accurately tracked to increase the effectiveness of understanding melanoma
recurrence and follow-up care.
Melanoma recurrence requires precise evaluation. As indicated by one study, patients who have undergone
treatment of primary melanoma, early detection ofa local recurrence has important implications. An isolated
local recurrence in a patient with favorable features can be treated with repeat wide local excision, with good
oncologic outcomes. For these patients, long-term prognosis is not adversely affected by the local recurrence if it
is detected and treated early, and 5-year survival continues to be a function of primary tumor thickness. 48 49 so 51
Regular clinical examination offers the highest diagnostic yield in detecting melanoma recurrences. 52
Common follow-up recommendations for all patients indicate the follow-up schedule is influenced by risk of
recurrence, prior primary melanoma, and family history of melanoma. It also includes other factors such as
atypical moles/dysplastic nevi. 53 For patients who present with stage I-II melanoma and are rendered free of
disease after initial treatment, recurrence rates are distributed as follows: approximately 15 to 20 percent are local
or in transit. 54 Data suggests the time between the risk of recurrence to reach its low plateau depends on the stage
of disease at first presentation. 55 In a retrospective study of patients who initially presented with stage l
melanoma (N = 1568), 80 percent of the 293 recurrences developed within the first 3 years, but some recurrences
(<8 percent) were detected 5 to IO years after the initial treatment. 56 A prospective study found that for patients
with stage I or II at initial presentation, the risk of recurrence reached a low level by 4.4 years after initial
diagnosis. 57 Therefore, we are proposing this measure to incentivize clinicians who treat patients with melanoma
to perform these potentially lifesaving exams.
The PRMR Clinician Recommendation Committee did not reach consensus in recommending the measure for
inclusion in MIPS. The committee agreed with the importance of the measure's intent. There was significant
concern raised about the burden of tracking and reporting, reliability of the measure and interpretation of testing
results, and the impact of lower reliability on clinician compensation. However, the measure was fully tested at
the clinician level and has been determined to be implementable in MIPS. The measure has been available for
MIPS reporting as a QCDR measure since 2022, which attests to its feasibility as no implementation issues have
been identified. This measure is not currently CBE endorsed. Although CBE endorsement is preferred, it is still
recommended this measure be added to Ml PS because it is an evidence-based measure, satisfying the
requirement set forth at section 1848(q)(2XD)(v) of the Act, stating that any measure selected for inclusion in
MIPS that is not endorsed by a CBE shall have a focus that is evidenced-based. This measure aligns with NCCN
guidelines.
This measure fills a gap in MIPS within the dermatologic clinical topic, as there are no other dermatology
measures related to the outcome of melanoma recurrence. There is potential to replace current structure measure
Q137: Melanoma: Continuity of Care with this more robust outcome measure as indicated in Table C.2 of this
Appendix. While the MIPS Dermatology specialty set includes 13 measures, only 6 are specialty specific. This
measure is relevant to specialty clinicians and could provide a new measure option for a specialty area that
currently encompasses many topped-out measures, while also potentially aiding in the development of a
meaningful MVP.
Note: Refer to the PRMR Clinician Recommendation Committee Spreadsheet of Final Recommendations to
CMS and HHS at https:/lp4qm.orglsites/default(files/2024-02/PRMR-Final-MJJC-RecommendationSpreadsheet%20%283%29.xlsx.
Rueth, N. M., Cromwell, K. D., & Cormier, J. N. (2015). Long-term Follow-up for Melanoma Patients: Is There Any
Evidence of a Benefit? Surgical Oncology Clinics of North America, 24(2), 359-377.
https://doi.org/10.1016/j .soc.2014.12.012.
49 Benvenuto-Andrade, C., Oseitutu, A., Agere, A. L., & Marghoob, A. A. (2005). Cutaneous Melanoma: Surveillance
of Patients for Recurrence and New Primary Melanomas. Dermatologic Therapy, 18(6), 423-435.
https://doi.org/10.1111/j.1529-8019 .2005.00049.x.
50 Garbe, C., Paul, A., Kohler-Spath, H., Ellwanger, U., Stroebel, W., Schwarz, M., Schlagenhauff, B., Meier, F.,
Schittek, B., Blaheta, H.J., Blum, A., & Rassner, G. (2003). Prospective Evaluation of a Follow-up Schedule in
Cutaneous Melanoma Patients: Recommendations for an Effective Follow-up Strategy. Journal of Clinical Oncology:
Official Journal of the American Society of Clinical Oncology, 21(3), 520-529.
https://doi.org/10.1200/JCO.2003.01.091.
51 Rhodes A. R. (2006). Cutaneous Melanoma and Intervention Strategies to Reduce Tumor-related Mortality: What
we know, what we don't know, and what we think we know that isn't so. Dermatologic Therapy, 19(1), 50-69.
https://doi.org/10.1111/j.1529-8019.2005.00056.x.
52 See footnote Rueth et al., 2015.
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Trotter, S. C., Sroa, N., Winkelmann, R. R., Olencki, T., & Bechtel, M. (2013). A Global Review of Melanoma
Follow-up Guidelines. The Journal of Clinical and Aesthetic Dermatology, 6(9), 18-26.
54 See footnote Trotter et al., 2013.
55 See footnote Trotter et al., 2013.
56 See footnote Trotter et al., 2013.
57 NCCN. NCCN Guidelines - Melanoma: Cutaneous. https://www.nccn.org/guidelines/guidelinesdetail?category=l&id=1492.
53
A.7. First Year Standardized Waitlist Ratio (FYSWR)
Cateiwrv
CBE#/
eCQMCBE#:
Qualitv #:
Description:
Measure Steward:
Numerator:
Denominator:
Exclusions:
NIA/NIA
TBD
The number of newly initiated patients on dialysis in a practitioner group who are under the age of75 and were either listed on
the kidney or kidney-pancreas transplant waitlist or received a living donor transplant within the first year of initiating dialysis.
The practitioner group is inclusive of physicians and advanced practice providers. The measure is the ratio-observed number of
waitlist events in a practitioner group to its expected number ofwaitlist events. The measure uses the expected waitlist events
calculated from a Cox model, which is adiusted for age, oatient comorbidities and other risk factors at the time of dialvsis.
Centers for Medicare & Medicaid Services
Numerator I. Patients who initiated dialysis and had documentation of status at the end of the first year after initiating dialysis.
Numerator 2. The ratio of the observed number ofwaitlist events in a practitioner group to the model-based expected number of
waitlist events.
Denominator 1. Patients aged 75 years of age or less who have initiated dialysis during January 1st December 31st of the
previous performance period.
Denominator 2. The denominator for the First Year Standardized Waitlist Ratio (FYSWR) is the total number of patients under
the age of 75 in the practitioner group according to each patient's treatment history for patients within the first year following
initiation of dialysis.
Patients admitted to a skilled nursing facility (SNF).
Patients in hospice on their initiation of dialysis date or during the month of evaluation.
Patients that were on the kidney or kidney-pancreas waitlist prior to initiation of dialysis.
Patients who had a transolant orior to initiation of dialvsis.
Process
No
MIPS CQM Specifications
EP31JY24.219
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from reporting outcomes.
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Collection Type:
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This measure was originally proposed in the CY 2024 PFS proposed rule (88 FR 52771 through 52772) but was not finalized in
the CY 2024 PFS final rule (88 FR 79565 through 88 FR 79566) due to implementation issues within MIPS regarding timing
and application of the risk adjustment methodology. We are again proposing this measure because it addresses a CMS high
priority clinical topic: patients with end-stage renal disease (ESRD). We indicated we would allow further refinement and
streamlining of the measure analytic for future MlPS implementation. The measure and measure analytic have been revised to
include two submission criteria, allowing for determination of data completeness and the full utilization of the risk-adjusted
model in the second submission criterion to create a continuous variable analytic, assessing the ratio of observed to expected
waitlist events.
ESRD affects nearly 786,000 Americans, and dialysis for ESRD patients represents a significant portion of annual Medicare
expenditures. 58 While dialysis is a treatment for ESRD, it is associated with increased mortality and lower quality oflife for
ESRD patients when compared to kidney transplant. 59 This measure assesses whether patients who are in their first year of
dialysis, and are found to be an expected waitlist event based upon the Cox model, were placed on either the kidney or kidneypancreas transplant waitlist or received a living donor kidney transplant. Data submitted by the measure developer indicates a
performance gap for a process that can be directly linked to improved patient outcomes. This measure is separate from the other
transplant waitlist measure, proposed under Table A.8 of this Appendix, as it is limited to assessing the first year after initiation
of dialysis and the timely addition of those patients to the transplant waitlist-a crucial step in driving positive outcomes in the
patient population.
National and large regional studies provide strong empirical support for the association between processes within the clinical
scope and control of dialysis practitioners followed by subsequent patient transplant wait listing. For example, the clinical
assessments, provisions and/or referrals made by a dialysis practitioner are contributing factors for consideration in patient
transplant wait listing. In one large regional study conducted on facilities in the state of Georgia, a standardized dialysis facility
referral ratio was developed, adjusted for age, demographics, and comorbidities. 60 There was substantial variability across
dialysis facilities in referral rates, and a Spearman correlation performed between ranking on the referral ratio and dialysis
facility waitlist rates was highly significant (r=0.35, p<0.001). 61 A national study using registry data (United States Renal Data
System) from 2005-2007 examined the association between whether patients were informed about kidney transplantation based
on reporting on the Medical Evidence Form 2728 (https:llwww.cms.gov/Medicare/CMS-Forms/CMSForms/Downloads/CMS2728.pdj) and subsequent access to kidney transplantation (wait listing or receipt ofa live donor
transplant).62 Approximately 30 percent of patients were uninformed about kidney transplantation, which was associated with
half the rate of access to transplantation compared to patients who were informed."' In a related survey study of 388
hemodialysis patients, whether provision of information about transplantation by nephrologists or dialysis staff occurred was
directly confirmed with patients.64 The provision of such information was associated with a near threefold increase in likelihood
of wait listing. 65
The intent of this measure is to track the initial placement on the kidney or kidney-pancreas transplantation waitlist or receipt of
a living donor transplant within the first year after dialysis initiation, with the intended objective of improving the overall health
of patients on dialysis. Being waitlisted or receiving a living donor kidney transplant represents a desirable change in health
status for patients on dialysis, indicating achievement of a health condition conducive to kidney transplantation. Waitlisting is a
direct step in the process of transplantation which drives quality by progressing patients towards the goal of transplantation and
better health outcomes. Being waitlisted for kidney transplantation is the culmination of a variety of preceding preparatory
activities, which may include providing education to patients about the option(s) of transplantation, referral of patients to a
transplant center for evaluation, completion of the evaluation process, and optimizing the health of the patient while on dialysis.
These efforts depend heavily and, in many cases, primarily, on dialysis practitioner groups. Aspects that are not directly in the
clinician/groups control can be influenced through coordination of care, strong communication with transplant centers, and
advocacy for patients. All clinicians should be involved and actively work towards providing patients with high quality care
including ensuring placement on the transplant list as quickly as possible.
The PRMR (formerly the MAP), did not support this measure for rulemaking with the potential for mitigation to update the
measure and address the concern from the Renal Standing Committee regarding the evidence base and specifications, and thus
recommended this measure be resubmitted for endorsement by a CBE. Although CBE endorsement is preferred, it is still
recommended this measure be added to MlPS because it is an evidence-based measure, satisfying the requirement set forth at
section 1848(qX2)(D)(v) of the Act, stating that any measure selected for inclusion in MlPS that is not endorsed by a CBE shall
have a focus that is evidenced-based. As discussed above, studies suggest a significant positive correlation between the clinician
activities and the addition of patients to a transplant waitlist, which are necessary for patients to receive the improved outcomes
associated with kidney transplant.
Note: Refer to the 2022 MUC List-Final Recommendations to CMS and HHS at
https:/lview.officeapps.live.comloplview.aspx?src=https%3A%2F"/42Fmmshub.cms.gov%2Fsites%2Fdefault%2Ffiles%2F2022MUC-List.xlsx&wdOriJ!in=BROWSELINK.
National Institute of Diabetes and Digestive and Kidney Diseases {NIDDK). {2023). Kidney Disease Statistics for
the United States. https://www.niddk.nih.gov/hea Ith-information/health-statistics/kidney-disease.
59 Wouk N. {2021). End-Stage Renal Disease: Medical Management. American Family Physician, 104(5), 493-499.
60 Paul, S., Plantinga, L. C., Pastan, S. 0., Gander, J. C., Mohan, S., & Patzer, R. E. (2018). Standardized
Transplantation Referral Ratio to Assess Performance of Transplant Referral among Dialysis Facilities. Clinical
Journal of the American Society of Nephrology, 13(2), 282-289. https://doi.org/l0.2215/CJN.04690417.
61 See footnote Paul et al., 2018.
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Kucirka, L. M., Grams, M. E., Bal hara, K. S., Jaar, B. G., & Segev, D. L. (2012). Disparities in Provision of Transplant
Information Affect Access to Kidney Transplantation. American Journal ofTransplantation, 12(2), 351-357.
https:// doi.org/10.1111/j.1600-6143.2011.03865.x.
63 See footnote Kucirka et al., 2012.
64 Salter, M. L., Orandi, B., McAdams-DeMarco, M.A., Law, A., Meoni, L.A., Jaar, B. G., ... & Segev, D. L. (2014).
Patient-and Provider-Reported Information about Transplantation and Subsequent Waitlisting. Journal of the
American Society of Nephrology, 25(12), 2871-2877. https://doi.org/10.1681/ASN.2013121298.
65 See footnote Salter et al., 2014.
62
A.8. Percentage of Prevalent Patients Waitlisted (PPPW) and Percentage of Prevalent Patients Waitlisted in Active Status
(aPPPW)
Cate1rnrv
CBE#/
eCQMCBE#:
Qualitv#:
Description:
Measure Steward:
Numerator:
Denominator:
Exclusions:
NIA/NIA
TBD
The measure tracks dialysis patients who are under the age of75 in a practitioner group and on the kidney or kidney-pancreas
transplant waitlist (all patients or patients in active status). This measure is a risk-adjusted percentage ofwaitlist events among
dialvsis oatients.
Centers for Medicare & Medicaid Services
Numerator I: Percentage of Prevalent Patients Waitlisted (PPPW): Patients in the practitioner group's denominator with
observed months on the waitlist for each month.
Numerator 2: Percentage of Prevalent Patients Waitlisted in Active (aPPPW): Patients in the practitioner group's denominator
with observed months on the waitlist in active status for each month.
Denominator I and 2: All risk-adjusted patient-months for patients who are under the age of 75 in the reporting month and who
are assigned to a dialysis practitioner or practitioner group practice according to each patient's treatment history on the last day
of each reporting month during the performance vear.
Patients who were admitted to a skilled nursing facility (SNF) during the month of evaluation were excluded from that month.
Patients who were admitted to a skilled nursing facility (SNF) within one year of dialysis initiation according to the CMS-2728
form.
Patients determined to be in hospice were excluded from month of evaluation and the remainder ofreporting period.
Patients with dementia at any time prior to or during the month.
Process
No
MIPS CQM Specifications
EP31JY24.222
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excluded from reporting outcomes.
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Hi!!h Priority Measure:
Collection Tvoe:
Measure-Specific Case
Minimum/Performance
Period:
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Catee:orv
62267
Descriotion
This measure was originally proposed in the CY 2024 PFS proposed rule (88 FR 52773 through 52774) but was not finalized in
the CY 2024 PFS final rule (88 FR 79567 through 79568) due to implementation issues within MIPS regarding timing and
application of the risk adjustment methodology. We are again proposing this measure because it addresses a CMS high priority
clinical topic: patients with ESRD. We indicated we would allow further refmement and streamlining of the measure analytic
for future MI PS implementation. The measure, including component calculations, was revised to allow for a proportional
analytic to be used for the purposes of determining measure performance, while still incorporating the risk-adjusted model to
ensure the appropriate denominator eligible patient population for numerator assessment.
ESRD affects nearly 786,000 Americans, and dialysis for ESRD patients represents a significant portion of annual Medicare
expenditures.''° While dialysis is a treatment for ESRD, it is associated with increased mortality and lower quality of life for
ESRD patients when compared to kidney transplant. 67 This measure would capture the adjusted count of patient months on the
kidney and kidney-pancreas transplant waitlists for all dialysis patients in a dialysis practitioner or group practice by assessing
patient status on the last day of each month during the reporting year, and those on the transplant waitlist in active status as of
the last day of the month during the reporting year. This process measure is directly linked to driving positive outcomes and
measure data indicates a performance gap.
Most ESRD patients have to wait for access to a deceased donor transplant, with the national median being roughly 4 years. 68
Maintenance of 'active status' on the transplant list requires ongoing collaboration between dialysis practitioners, transplant
centers, and transplant networks, thereby ensuring sustained suitability for a transplant while optimizing the health ofpatients. 69
This maintenance process is associated with higher transplantation rates and lowered mortality rates while on the waitlist. 70 In
addition, the maintenance of'active status' is an important health equity issue. Research has found disparities in access to
kidney transplant by race. 71 Race-neutral efforts by clinicians to encourage maintenance of patients on the waitlist may reduce
such disparities while improving their performance on this measure. 72
Rationale:
This measure and the previously proposed measure under Table A.7, the First Year Standardized Waitlist Ratio measure, work
in tandem to assess initial and on-going care. This measure would assess monthly wait listing in active status of patients. It also
would evaluate and encourage maintenance of patients on the waitlist. This is an important area to which dialysis practitioners
can contribute through ensuring patients remain healthy and complete any ongoing testing activities required to remain active
on the waitlist. In contrast to this measure, the First Year Standardized Waitlist Ratio measure would focus solely on new wait
listings and living donor kidney transplants to incentivize early action, rather than ongoing maintenance on the waitlist, which
this measure assesses.
The PRMR conditionally supported this measure for rulemaking pending an update of the measure's specifications to include
only the PPPW (CBE 3695) rate that was recommended for endorsement by the CBE's Renal Standing Committee. Although
CBE endorsement is preferred, it is still recommended this measure be added to MIPS because it is an evidence-based measure,
satisfying the requirement set forth at section 1848(q)(2)(DXv) of the Act, stating that any measure selected for inclusion in
MTPS that is not endorsed by a CBE shall have a focus that is evidenced-based. The CBE recommended endorsement for the
PPPW subset of this measure. It is important to include the aPPPW rate in this measure as well to capture patients in active
waitlist status, and the full scope of the transplant list with movement of patients between active and inactive status. The studies
cited above provide the evidentiary basis for the adoption of this measure. After review, it was determined that the testing
provided by the measure steward demonstrated statistically sufficient results for the reliability and validity of each of the
numerator actions, meeting requirements described within the CMS MMS Hub (https:llmmshub.cms.govl) regarding quality
measure testing.
Note: Refer to the 2022 MUC List-Final Recommendations to CMS and HHS at
https:llview.officeapps.live.comloplview.aspx?src=https%3A%2F"/o2Fmmshub.cms.gov%2Fsites%2Fdefault%2Ffiles%2F2022MUC-List.xlsx&wdOrif!in=BROWSELINK.
See footnote NIDDK, 2023.
See footnote Wouk, 2021.
68 Johansen, K. L., Chertow, G. M., Foley, R. N., Gilbertson, D. T., Herzog, C. A., lshani, A., ... & Wetmore, J. B.
(2021). US Renal Data System 2020 Annual Data Report: Epidemiology of Kidney Disease in the United
States. American Journal of Kidney Diseases, 77(4), A7-A8. https://www.ajkd.org/article/S0272-6386(21)00024X/fulltext.
69 Grams, M. E., Massie, A. B., Schold, J. 0., Chen, B. P., & Segev, D. L. (2013). Trends in the Inactive Kidney
Transplant Waitlist and Implications for Candidate Survival. American Journal ofTransplantation, 13(4), 1012-1018.
https://on linelibrary. wi ley .com/doi/pdf/10.1111/ajt.12143.
70 See footnote Grams et al., 2013.
71 Kulkarni, S., Ladin, K., Haakinson, 0., Greene, E., Li, L., & Deng, Y. (2019). Association of Racial Disparities with
Access to Kidney Transplant after the Implementation of the New Kidney Allocation System. JAMA surgery, 154(7),
618-625. https://jamanetwork.com/journals/jamasurgery/fullarticle/2729436.
72 See footnote Kulkarni et al., 2019.
66
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Table Group B: New Specialty Measure Sets Proposed for Addition and Modifications to
Previously Finalized Specialty Measure Sets Proposed for the CY 2025 Performance
Period/2027 MIPS Payment Year and Future Years
We are proposing to add one new specialty measure set: Optometry. In the CY 2023 PFS final rule, we finalized a combined
Ophthalmology/Optometiy specialty set (87 FR 70275 and 87 FR 70434 through 70439). Based on interested parties' request, we
are proposing to revert this combined specialty set to "Ophthalmology" under Table 8.28 of this Appendix with all measures
retained as finalized under the CY 2024 PFS final rule (88 FR 79777 through 79784). We are simultaneously proposing to create a
separate Optometry specialty set with a more limited number of quality measures based on differences in scope of practice to
ophthalmology. The Optometiy specialty set is proposed for comment under Table B.29 of this Appendix.
We are proposing to modify the below previously finalized specialty measure sets based upon review of updates made to existing
quality measure specifications, the proposed addition of new measures for inclusion in MIPS, and feedback provided by specialty
societies. There may be instances where the quality measures within a specialty set remain static, but the individual measures
have proposed substantive changes in Table Group D of this Appendix. In the first column, existing measures with substantive
changes described in Table Group D of this Appendix are noted with an asterisk(*), core measures that align with Core Quality
Measure Collaborative (CQMC) core measure set(s) are noted with the symbol(§), and high priority measures are noted with an
exclamation point(!). The Indicator column includes a "high priority type" in parentheses after each high priority indicator(!) to
represent the regulatory definition of high priority measures. In addition, eCQMs that are endorsed by a CBE are shown in Table
Group B of this Appendix as follows: CBE # / eCQM CBE #.
Under§ 414.1305, a high priority measure means an outcome (including intermediate-outcome and patient-reported outcome),
appropriate use, patient safety, efficiency, patient experience, care coordination, opioid, or health equity-related quality measure.
Further details of these types of measures may be found in the CMS Measures Management System Hub
(https:/lmmshub.cms.govl).
Previously finalized measures that have no substantive changes are not open for comment under this proposed rule. We seek
comment on proposed additions and proposed removals under applicable specialty sets in Table Group B of this Appendix.
The following specialty sets have no measures added, no measures removed, and no substantive changes proposed for the CY
2025 performance period/2027 MIPS payment year: Anesthesiology and Dentistry.
The following specialty sets have no measures added and no measures removed, but have substantive changes proposed as
addressed under Table Group D: Audiology, Electrophysiology Cardiac Specialist, Certified Nurse Midwife, Chiropractic
Medicine, Diagnostic Radiology, General Surgery, Hospitalists, Mental/Behavioral Health and Psychiatry, Neurology,
Nutrition/Dietician, Ophthalmology, Orthopedic Surgery, Pathology, Pediatrics, Physical Medicine, Physical
Therapy/Occupational Therapy, Plastic Surgery, Podiatry, and Thoracic Surgery.
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Note: In the CY 2024 PFS final rule, new measure Q494: Excessive Radiation Dose or Inadequate Image Quality for Diagnostic
Computed Tomography (CT) in Adults (Clinician Level) was finalized with a I-year delay to the 2025 performance period (88
FR 79556 through 79560). As a result, measure Q436: Radiation Consideration for Adult CT: Utilization of Dose Lowering
Techniques was finalized for removal with a I-year delay to the 2025 performance period (88 FR 79896). These decisions are
reflected within table B. l ODiagnostic Radiology specialty set of this Appendix.
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B.1. Allergy/Immunology
In addition to the considerations discussed in the introductory language of Table Group B of this Appendix to this proposed rule,
the Allergy/Immunology specialty set takes additional criteria into consideration, which includes, but is not limited to: whether a
measure reflects current clinical guidelines, and the coding of the measure includes relevant clinician types. We may reassess the
appropriateness of individual measures, on a case-by-case basis, to ensure appropriate inclusion in the specialty set. Measure
tables in this set include previously finalized measures we are maintaining within the set, measures proposed to be added, and
measures proposed for removal, as applicable. We request comment on the measures available in the proposed Allergy/
Immunology specialty set.
8.1. Allergy/Immunology
§
!
(Patient
Safety)
§
*
!
(Patient
Safe
*
*
!
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Medicaid
Services
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Committee
for Quality
Assurance
National
Committee
for Quality
Assurance
Centers for
Medicare&
Medicaid
Services
Process
Adult Sinusitis: Antibiotic Prescribed
for Acute Viral Sinusitis (Overuse):
Percentage of patients, aged 18 years and
older, with a diagnosis of acute viral
sinusitis who were prescribed an antibiotic
within 10 days after onset of symptoms.
American
Academy
of
Otolaryngo
logyHead and
Neck
Surgery
Foundation
Process
Adult Sinusitis: Appropriate Choice of
Antibiotic: Amoxicillin With or
Without Clavulanate Prescribed for
Patients with Acute Bacterial Sinusitis
(Appropriate Use):
Percentage of patients aged 18 years and
older with a diagnosis of acute bacterial
sinusitis that were prescribed amoxicillin,
with or without clavulanate, as a first line
antibiotic at the time of di nosis.
American
Academy
of
Otolaryngo
logyHead and
Neck
Surgery
Foundation
Sfmt 4725
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31JYP2
EP31JY24.225
*
Documentation of Current Medications
in the Medical Record:
Percentage of visits for patients aged 18
years and older for which the eligible
clinician attests to documenting a list of
current medications using all immediate
resources available on the date of the
encounter.
Preventive Care and Screening:
Tobacco Use: Screening and Cessation
Intervention:
Percentage of patients aged 12 years and
older who were screened for tobacco use
one or more times during the measurement
period AND who received tobacco
cessation intervention during the
measurement period or in the 6 months
prior to the measurement period if
identified as a tobacco user.
Use of High-Risk Medications in Older
Adults:
Percentage of patients 65 years of age and
older who were ordered at least two highrisk medications from the same dru class.
Preventive Care and Screening:
Screening for High Blood Pressure and
Follow-Up Documented:
Percentage of patient visits for patients
aged 18 years and older seen during the
measurement period who were screened
for high blood pressure AND a
recommended follow-up plan is
documented, as indicated, if blood
ressure is elevated or h ertensive.
62270
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B.1. Allergy/Immunology
!
(Outcome)
*
§
!
(Efficiency)
*
!
(Care
Coordination)
!
(Outcome)
(Equity)
•
*
!
(Equity)
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Process
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-Based
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Health
Resources
and
Services
Admioistrat
ion
Health
Resources
and
Services
Admioistrat
ion
Centers for
Medicare &
Medicaid
Services
Minnesota
Community
Measureme
nt
Centers for
Medicare &
Medicaid
Services
National
Committee
for Quality
Assurance
OCHTN
Insignia
Health,
LLC,a
wholly
owned
subsidiary
of Phreesia
EP31JY24.226
§
eCQM
Specifications,
MTPSCQM
Specifications
HIV Viral Suppression:
Percentage of patients, regardless of age,
diagnosed with illV prior to or during the
first 90 days of the performance period,
with an eligible encounter io the frrst 240
days of the performance period, whose
last HIV viral load test result was less than
200 copieslmL during the performance
eriod.
HIV Medical Visit Frequency:
Percentage of patients, regardless of age
with a diagnosis of HIV who had at least
one medical visit in each 6-month period
of the 24-month measurement period, with
a minimum of60 days between medical
visits.
Closing the Referral Loop: Receipt of
Specialist Report:
Percentage of patients with referrals,
regardless of age, for which the referring
clinician receives a report from the
clinician to whom the atient was referred.
Optimal Asthma Control:
Composite measure of the percentage of
pediatric and adult patients whose asthma
is well-controlled as demonstrated by one
of three age appropriate patient reported
outcome tools and not at risk for
exacerbation.
Screening for Social Drivers of Health:
Percent of patients 18 years and older
screened for food insecurity, housing
instability, transportation needs, utility
difficulties and iote ersonal safe
Adult Immunization Status:
Percentage of patients 19 years of age and
older who are up-to-date on recommended
routine vaccioes for iofluenza; tetanus and
diphtheria (Td) or tetanus, diphtheria and
acellular pertussis (Tdap); zoster; and
neumococcal.
Connection to Community Service
Provider:
Percent of patients 18 years or older who
screen positive for one or more of the
following health related social needs
(HRSNs): food insecurity, housing
instability, transportation needs, utility
help needs, or interpersonal safety; and
had contact with a Community Service
Provider (CSP) for at least one of their
HRSNs within 60 da s after screenin .
Gains in Patient Activation Measure
(PAM®) Scores at 12 Months:
The Patient Activation Measure®
(PAM®) is a 10-or 13 - item
questionnaire that assesses an iodividual •s
knowledge, skills and confidence for
managing their health and health care. The
measure assesses individuals on a 0-100
scale that converts to one of four levels of
activation, from low ( 1) to high (4 ). The
PAM® performance measure (PAM®PM) is the change in score on the PAM®
from baseline to follow-u measurement.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62271
B.1. Allergy/Immunology
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Services
lkeokwu, A. E., Lawrence, R., Osieme, E. D., Gidado, K. M., Guy, C., & Dolapo, 0. (2023). Unveiling the Impact of
COVID-19 Vaccines: A Meta-Analysis of Survival Rates Among Patients in the United States Based on Vaccination
Status. Cureus, 15(8), e43282. https://doi.org/10.7759/cureus.43282.
74 See footnotes Fitzpatrick et al., 2022; Polack et al., 2020; and Grana et al., 2022 in Table A.5 of this Appendix.
73
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AdultCOVID-19
Vaccination
Status:
Percentage of
patients aged 18
years and older
seen for a visit
during the
performance
period that are upto-date on their
COVID-19
vaccinations as
defined by CDC
recommendations
on current
vaccination.
We are proposing to include
this measure in the Allergy/
Immunology specialty set as it
would be clinically relevant to
this clinician type. Widespread
vaccination against SARSCo V-2, the virus that causes
COVJD-19, is critically
important to stemming the
morbidity and mortality caused
by this disease. 73 Clinicians are
uniquely positioned to
encourage uptake ofCOVID19 vaccination, and clinicians
are still a major driving force
in promoting patient
vaccination. The addition of
this quality measure in this
specialty set would help
strengthen compliance with
recommended COVID-19
vaccination, leading to
improvement in the quality of
patient care and prevention of
disease for the general
population. This quality
measure aligns with clinical
guidelines and the evidencebased recommendations of the
ACIP, where there is general
agreement about the safety and
efficacy of the COVlD-19
vaccine, preventing costly and
potentially harmful
hospitalizations. 74 Broadening
vaccination status awareness to
this clinician type is valuable
as it can help drive an increase
in the adult vaccination rates.
The COVJD-19 vaccination
included within this measure
would reduce the prevalence of
severe diseases that may be
associated with hospitalization
and decrease overall health
care costs. The measure being
added to this specialty set
would be contingent on the
inclusion ofapplicable coding
by the time of the CY 2025
PFS final rule. ln the event
appropriate coding is not
included in the final
specification, this measure
would not be finalized for
inclusion within this specialty
measure set. See Table A.5 of
this Appendix for rationale,
includin clinical evidence
62272
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B.1. Allergy/Immunology
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62273
B.2. Anesthesiology
In addition to the considerations discussed in the introductory language of Table Group B of this Appendix to this proposed rule,
the Anesthesiology specialty set takes additional criteria into consideration, which includes, but is not limited to: whether a
measure reflects current clinical guidelines, and the coding of the measure includes relevant clinician types. We may reassess the
appropriateness of individual measures, on a case-by-case basis, to ensure appropriate inclusion in the specialty set. Measure
tables in this set include previously finalized measures we are maintaining within the set, as applicable. This specialty set has no
proposed changes.
B.2. Anesthesiology
(Outcome)
!
(Outcome)
!
(Patient
Safety)
!
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(Patient
Safety)
VerDate Sep<11>2014
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404
NIA
MIPS CQM
Specifications
Intermediate
Outcome
NIAi
NIA
424
NIA
MIPSCQM
Specifications
Outcome
NIAi
NIA
430
NIA
MIPSCQM
Specifications
Process
NIA
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Specifications
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of
Anesthesiologists
American Society
of
Anesthesiologists
American
Society of
Anesthesiologists
American
Society of
Anesthesiologists
EP31JY24.229
!
Anesthesiology Smoking
Abstinence:
The percentage of current
smokers who abstain from
cigarettes prior to anesthesia on
the day of elective surgery or
rocedure.
Perioperative Temperature
Management: Percentage of
patients, regardless of age, who
undergo surgical or therapeutic
procedures under general or
neuraxial anesthesia of60
minutes duration or longer for
whom at least one body
temperature greater than or equal
to 35.5 degrees Celsius (or 95.9
degrees Fahrenheit) was
achieved within the 30 minutes
immediately before or 15
minutes immediately after
anesthesia end time.
Prevention of Post-Operative
Nausea and Vomiting (PONY)
- Combination Therapy:
Percentage of patients, aged I 8
years and older, who undergo a
procedure under an inhalational
general anesthetic, AND who
have three or more risk factors
for post-operative nausea and
vomiting (PONY), who receive
combination therapy consisting
ofat least two prophylactic
pharmacologic anti-emetic
agents of different classes
preoperatively and/or
intrao rativel .
Prevention of Post-Operative
Vomiting (POV)Combination Therapy
(Pediatrics):
Percentage of patients aged 3
through 17 years, who undergo a
procedure under general
anesthesia in which an
inhalational anesthetic is used for
maintenance AND who have two
or more risk factors for postoperative vomiting (POV), who
receive combination therapy
consisting of at least two
prophylactic pharmacologic antiemetic agents of different classes
preoperatively and/or
intrao rativel •.
62274
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B.2. Anesthesiology
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Society of
Anesthesiologists
EP31JY24.230
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Multimodal Pain Management:
Percentage of patients, aged 18
years and older, undergoing
selected surgical procedures that
were managed with multimodal
ain medicine.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62275
B.3. Audiology
In addition to the considerations discussed in the introductory language of Table Group B of this Appendix to this proposed rule,
the Audiology specialty set takes additional criteria into consideration, which includes, but is not limited to: whether a measure
reflects current clinical guidelines, and the coding of the measure includes relevant clinician types. We may reassess the
appropriateness of individual measures, on a case-by-case basis, to ensure appropriate inclusion in the specialty set. Measure
tables in this set include previously finalized measures we are maintaining within the set, measures proposed to be added, and
measures proposed for removal, as applicable. We request comment on the measures available in the proposed Audiology
specialty set that have proposed substantive changes in Table Group D of this Appendix as indicated by an* in the Indicator
column.
B.3. Audiology
§
!
(Patient
Safety)
§
NIAi
NIA
NIAi
NIA
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134
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Specifications,
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Measure
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Process
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*
!
(Care
Coordination)
*
!
(Patient
Safety)
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§
(Care
Coordination)
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Falls: Plan of Care:
Percentage of patients aged 65
years and older with a history of
falls who had a plan of care for falls
documented within 12 months.
Elder Maltreatment Screen and
Follow-Up Plan:
Percentage of patients aged 60
years and older with a documented
elder maltreatment screen using an
Elder Maltreatment Screening tool
on the date of encounter AND a
documented follow-up plan on the
date of the ositive screen.
Functional Outcome Assessment:
Percentage of visits for patients
aged 18 years and older with
documentation of a current
functional outcome assessment
using a standardized functional
outcome assessment tool on the
date of the encounter AND
documentation of a care plan based
on identified functional outcome
deficiencies within 2 days of the
date of the identified deficiencies.
E:\FR\FM\31JYP2.SGM
31JYP2
Centers for
Medicare &
Medicaid
Services
Centers for
Medicare&
Medicaid
Services
National
Committee for
Quality
Assurance
Centers for
Medicare &
Medicaid
Services
Centers for
Medicare&
Medicaid
Services
EP31JY24.231
*
Documentation of Current
Medications in the Medical
Record:
Percentage of visits for patients
aged 18 years and older for which
the eligible clinician attests to
documenting a list of current
medications using all immediate
resources available on the date of
the encounter.
Preventive Care and Screening:
Screening for Depression and
Follow-Up Plan:
Percentage of patients aged 12
years and older screened for
depression on the date of the
encounter or up to 14 days prior to
the date of the encounter using an
age-appropriate standardized
depression screening tool AND if
positive, a follow-up plan is
documented on the date of or up to
two days after the date of the
uali in encounter.
62276
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
B.3. Audiology
. J?RltVt0LJ$LYFll'IALIZED!\1EASlJ.«ES1N THEAUDIOL6GY.81'ECIALn: $ET
..
. lndicatrii
·. · .i ....
(Patient
Safety)
NA!
NA
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B Claims
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B Claims
Measure
Specifications,
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Specifications,
MIPS CQM
Specifications
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0101 /
NIA
318
CMS139vl
3
eCQM
Specifications
NIA
MIPS CQM
Specifications
NIA
MIPS CQM
Specifications
2152/
NIA
!
(Equity)
226
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B Claims
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Preventive Care and Screening:
Tobacco lJse: Screening and
Cessation Intervention:
Percentage of patients aged 12
years and older who were screened
for tobacco use one or more times
during the measurement period
AND who received tobacco
cessation intervention during the
measurement period or in the 6
months prior to the measurement
period if identified as a tobacco
user.
Referral for Otologic Evaluation
for Patients with Acnte or
Chronic Dizziness:
Percentage of patients aged birth
and older referred to a physician
(preferably a physician specially
trained in disorders of the ear) for
an otologic evaluation subsequent
to an audiologic evaluation after
presenting with acute or chronic
dizziness.
Preventive Care and Screening:
Screening for High Blood
Pressure and Follow-Up
Documented: Percentage of patient
visits for patients aged 18 years and
older seen during the measurement
period who were screened for high
blood pressure AND a
recommended follow-up plan is
documented, as indicated, if blood
pressure is elevated or
hvoertensive.
Falls: Screening for Future Fall
Risk:
Percentage of patients 65 years of
age and older who were screened
for future fall risk during the
measurement oeriod.
Preventive Care and Screening:
Unhealthy Alcohol Use:
Screening & Brief Counseling:
Percentage of patients aged 18
years and older who were screened
for unhealthy alcohol use using a
systematic screening method at
least once within the last 12 months
AND who received brief counseling
if identified as an unhealthy alcohol
user.
Screening for Social Drivers of
Health:
Percent of patients 18 years and
older screened for food insecurity,
housing instability, transportation
needs, utility difficulties, and
interoersonal safetv.
E:\FR\FM\31JYP2.SGM
31JYP2
•···
.
National
Committee
for Quality
Assurance
Audiology
Quality
Consortium
Centers for
Medicare &
Medicaid
Services
National
Committee
for Quality
Assurance
National
Committee
for Quality
Assurance
Centers for
Medicare &
Medicaid
Services
EP31JY24.232
!
...
·s1:ewa.r4
'••
NIAi
N/A
!
(Care
Coordination)
.
Measu.re ... ·•·
62277
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B.3. Audiology
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(Equity)
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OCHIN
EP31JY24.233
*
Connection to Community
Service Provider:
Percent of patients 18 years or older
who screen positive for one or more
of the following health related
social needs (HRSNs): food
insecurity, housing instability,
transportation needs, utility help
needs, or interpersonal safety; and
had contact with a Community
Service Provider (CSP) for at least
one of their HRSNs within 60 days
after screenin .
62278
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
B.4a. Cardiology
In addition to the considerations discussed in the introductory language of Table Group B of this Appendix to this proposed rule,
the Cardiology specialty set takes additional criteria into consideration, which includes, but is not limited to: whether a measure
reflects current clinical guidelines, and the coding of the measure includes relevant clinician types. We may reassess the
appropriateness of individual measures, on a case-by-case basis, to ensure appropriate inclusion in the specialty set. Measure
tables in this set include previously finalized measures we are maintaining within the set, measures proposed to be added, and
measures proposed for removal, as applicable. We request comment on the measures available in the proposed Cardiology
specialty set.
B.4a. Cardiology
0081 I
0081e
005
CMS13
5v13
eCQM
Specifications,
MIPSCQM
Specifications
Process
§
0067 I
NIA
006
NIA
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Specifications
Process
007
CMS14
5v13
eCQM
Specifications,
MIPSCQM
Specifications
Process
008
CMS14
4vl3
eCQM
Specifications,
MIPSCQM
Specifications
Process
§
lotter on DSK11XQN23PROD with PROPOSALS2
§
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American Heart
Association
American Heart
Association
American Heart
Association
American Heart
Association
EP31JY24.234
§
Heart Failure (HF):
Angiotensin-Converting
Enzyme (ACE) Inhibitor or
Angiotensin Receptor Blocker
(ARB) or Angiotensin
Receptor-Neprilysin Inhibitor
(ARNI) Therapy for Left
Ventricular Systolic
Dysfunction (LVSD):
Percentage of patients aged 18
years and older with a diagnosis
of heart failure (HF) with a
current or prior left ventricular
ejection fraction (L VEF) :S 40%
who were prescribed ACE
inhibitor or ARB or ARNI
therapy either within a 12-month
period when seen in the
outpatient setting OR at each
hos ital dischar e.
Coronary Artery Disease
(CAD): Antiplatelet Therapy:
Percentage of patients aged 18
years and older with a diagnosis
ofcoronary artery disease (CAD)
seen within a 12-month period
who were prescribed aspirin or
clo ido el.
Coronary Artery Disease
(CAD): Beta-Blocker TherapyPrior Myocardial Infarction
(Ml) or Left Ventricular
Systolic Dysfunction (LVEF :S
40%):
Percentage of patients aged 18
years and older with a diagnosis
of coronary artery disease seen
within a 12-month period who
also have a prior Ml or a current
or prior LVEF :S 40% who were
rescribed beta-blocker thera
Heart Failure (HF): BetaBlocker Therapy for Left
Ventricular Systolic
Dysfunction (LVSD):
Percentage of patients aged 18
years and older with a diagnosis
of heart failure (HF) with a
current or prior left ventricular
ejection fraction (L VEF) <:: 40%
who were prescribed beta-blocker
therapy either within a 12-month
period when seen in the
outpatient setting OR at each
hos ital dischar e.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62279
B.4a. Cardiology
!
(Care
Coordination)
§
0326
/NIA
047
NIA
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B Claims
Measure
Specifications,
MIPS CQM
Specifications
0066 I
NIA
118
NIA
MIPS CQM
Specifications
Process
NIA/NIA
130
CMS68
vl4
eCQM
Specifications,
MIPS CQM
Specifications
Process
NIA/NIA
187
NIA
MIPS CQM
Specifications
Process
CMS13
8vl3
Medicare Part
B Claims
Measure
Specifications,
eCQM
Specifications,
MIPS CQM
Specifications
*
§
!
(Patient
Safety)
§
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31JYP2
National
Committee for
Quality
Assurance
American
Heart
Association
Centers for
Medicare &
Medicaid
Services
American Heart
Association
National
Committee for
Quality
Assurance
EP31JY24.235
*
Advance Care Plan:
Percentage of patients aged 65
years and older who have an
advance care plan or surrogate
decision maker documented in the
medical record or documentation
in the medical record that an
advance care plan was discussed
but the patient did not wish or
was not able to name a surrogate
decision maker or provide an
advance care Ian.
Coronary Artery Disease
(CAD): Angiotensin-Converting
Enzyme (ACE) Inhibitor or
Angiotensin Receptor Blocker
(ARB) Therapy - Diabetes or
Left Ventricular Systolic
Dysfunction (LVEF :5 40%):
Percentage of patients aged 18
years and older with a diagnosis
of coronary artery disease seen
within a 12-month period who
also have diabetes OR a current
or prior Left Ventricular Ejection
Fraction (L VEF) :5 40% who
were prescribed ACE inhibitor or
ARB thera
Documentation of Current
Medications in the Medical
Record:
Percentage of visits for patients
aged 18 years and older for which
the eligible clinician attests to
documenting a list of current
medications using all immediate
resources available on the date of
the encounter.
Stroke and Stroke
Rehabilitation: Thrombolytic
Therapy:
Percentage of patients aged 18
years and older with a diagnosis
of acute ischemic stroke who
arrive at the hospital within 3.5
hours of time last known well and
for whom TV thrombolytic
therapy was initiated within 4.5
hours of time last known well.
Preventive Care and Screening:
Tobacco Use: Screening and
Cessation Intervention:
Percentage of patients aged 12
years and older who were
screened for tobacco use one or
more times during the
measurement period AND who
received tobacco cessation
intervention during the
measurement period or in the 6
months prior to the measurement
period if identified as a tobacco
user.
62280
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B.4a. Cardiology
CMSl6
5vl3
0022/
NIA
238
CMSl5
6vl3
eCQM
Specifications,
MIPSCQM
Specifications
Process
0643 /
NIA
243
NIA
MlPSCQM
Specifications
Process
CMS22
vl3
Medicare Part
BClaims
Measure
Specifications,
eCQM
Specifications,
MIPSCQM
Specifications
Process
NIA
MJPSCQM
Specifications
*
§
!
NIA/NIA
(Outcome)
*
!
(Patient
Safety)
!
(Care
Coordination)
NIAi
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*
*
!
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322
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National
Committee for
Quality
Assurance
National
Committee for
Quality
Assurance
American Heart
Association
Centers for
Medicare&
Medicaid
Services
American
College of
Cardiology
Foundation
EP31JY24.236
236
Medicare Part
BClaims
Measure
Specifications,
eCQM
Specifications,
MlPSCQM
Specifications
Controlling High Blood
Pressure:
Percentage of patients 18-85
years of age who had a diagnosis
of essential hypertension starting
before and continuing into, or
starting during the first 6 months
of the measurement period, and
whose most recent blood pressure
was adequately controlled
(2014
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American Heart
Association
Society for
Vascular
Surgeons
Centers for
Medicare &
Medicaid
Services
National
Committee for
Quality
Assurance
EP31JY24.237
§
Atrial Fibrillation and Atrial
Flutter: Chronic
Anticoagulation Therapy:
Percentage of patients aged 18
years and older with atrial
fibrillation (AF) or atrial flutter
who were prescribed an FDAapproved oral anticoagulant drug
for the prevention of
thromboembolism during the
measurement eriod.
Rate of Carotid Artery Sten ting
(CAS) for Asymptomatic
Patients, Without Major
Complications (Discharged to
Home by Post-Operative Day
#2):
Percent of asymptomatic patients
undergoing CAS who are
discharged to home no later than
ost-o erative da #2.
Closing the Referral Loop:
Receipt of Specialist Report:
Percentage of patients with
referrals, regardless of age, for
which the referring clinician
receives a report from the
clinician to whom the patient was
referred.
Preventive Care and Screening:
Unhealthy Alcohol Use:
Screening & Brief Counseling:
Percentage of patients aged 18
years and older who were
screened for unhealthy alcohol
use using a systematic screening
method at least once within the
last 12 months AND who
received brief counseling if
identified as an unhealthy alcohol
user.
62282
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B.4a. Cardiology
NIAINIA
438
CMS34
7v8
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Specifications,
MIPSCQM
Specifications
Process
NIAINIA
441
NIA
MIPS CQM
Specifications
Intermedi
ate
Outcome
NIA
MIPSCQM
Specifications
§
!
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Centers for
Medicare &
Medicaid
Services
Wisconsin
Collaborative
for Healtl1care
Quality
Centers for
Medicare &
Medicaid
Services
EP31JY24.238
§
Statin Therapy for the
Prevention and Treatment of
Cardiovascular Disease:
Percentage of the following
patients - all considered at high
risk of cardiovascular events who were prescribed or were on
statin therapy during the
performance period:
• All patients who were previously
diagnosed with or currently have
a diagnosis of clinical
atherosclerotic cardiovascular
disease (ASCVD), including an
ASCVD procedure; OR
•Patients aged 20 to 75 years who
have ever had a low-density
lipoprotein cholesterol (LDL-C)
level 2: 190 mg/dL or were
previously diagnosed with or
currently have an active diagnosis
of familial hypercholesterolemia;
OR;
•Patients aged 40 to 75 years with
a diagnosis of diabetes; OR;
•Patients aged 40 to 75 with a 10year ASCVD risk score of::: 20
ercent.
Ischemic Vascular Disease
(IVD) All or None Outcome
Measure (Optimal Control):
The IVD All-or-None Measure is
one outcome measure (optimal
control). The measure contains
four goals. All four goals within a
measure must be reached in order
to meet that measure. The
numerator for the all-or-none
measure should be collected from
the organization's total IVD
denominator. All-or-None
Outcome Measure (Optimal
Control) - Using the IVD
denominator optimal results
include:
• Most recent blood pressure
(BP) measurement is less than or
equal to 140190 mm Hg--AND
• Most recent tobacco status is
Tobacco Free -- AND
• Daily Aspirin or Other
Antiplatelet Unless
Contraindicated -- AND
• Slatin Use Unless
Contraindicated.
Screening for Social Drivers of
Health:
Percent of patients 18 years and
older screened for food
insecurity, housing instability,
transportation needs, utility
difficulties, and interpersonal
safe
62283
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
B.4a. Cardiology
.
•
,'Jndiciitor
.·
••
JN TH'..E; CARJ>IOLOGYSPJ?,CIALTY .SET
.·: PR:EViOUSLY FJNALIZEl) MEASURES
••.
. .
·.
(:BE#!
CMS
Measut"e
Quality
Collection
.Measure Title
Typ~
••
: eCQM
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eCQM I .••• Type
CijE.#.
*
*
!
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.
•.. ·•
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PatientReported
OutcomeBased
Performan
ce
Measure
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• and Descriptiofl .. .•·
Adult Immunization Status:
Percentage of patients 19 years of
age and older who are up-to-date
on recommended routine vaccines
for influenza; tetanus and
diphtheria (Td) or tetanus,
diphtheria and acellular pertussis
(Tdap); zoster; and
pneumococcal.
Connection to Community
Service Provider:
Percent of patients 18 years or
older who screen positive for one
or more of the following health
related social needs (HRSNs):
food insecurity, housing
instability, transportation needs,
utility help needs, or interpersonal
safety; and had contact with a
Community Service Provider
( CSP) for at least one of their
HRSNs within 60 days after
screening.
Gains in Patient Activation
Measure (PAM®) Scores at 12
Months:
The Patient Activation Measure®
(PAM®) is a 10- or 13 - item
questionnaire that assesses an
individual's knowledge, skills and
confidence for managing their
health and health care. The
measure assesses individuals on a
0-100 scale that converts to one
of four levels of activation, from
low (1) to high (4). The PAM®
performance measure (PAM®PM) is the change in score on the
PAM® from baseline to followup measurement.
E:\FR\FM\31JYP2.SGM
31JYP2
...
.·
.·
:
:Measurr
..
Steward'
National
Committee for
Quality
Assurance
OCHTN
Insignia Health,
LLC, a wholly
owned
subsidiary of
Phreesia
EP31JY24.239
.·•··
..
62284
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
8.4a. Cardiology
!
(Outcome
495
NIA
MIPSCQM
Specifications
American
Academy
of Hospice
and
Palliative
Medicine
(AAHPM)
75 Kilic, Y., Smer, A., & Goldstein, N. (2020). The Importance of Palliative Care in Cardiology: Differences Between
Countries. JACC. Case Reports, 2(2), 326-329. https://doi.org/10.1016/j.jaccas.2019.11.069.
76 National Consensus Project for Quality Palliative Care. (2018). Clinical Practice Guidelines for Quality Palliative
Care, 4th edition. https://www.nationalcoalitionhpc.org/ncp.
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PatientReported
Outcome
-Based
Perform
ance
Measure
Ambulatory
Palliative Care
Patients'
Experience of
Feeling Heard
and
Understood:
The percentage
of top-box
responses among
patients aged 18
years and older
who had an
ambulatory
palliative care
visit and report
feeling heard and
understood by
their palliative
care clinician and
team within 2
months (60 days)
ofthe
ambulatory
palliative care
visit.
We are proposing to include
this measure in the Cardiology
specialty set as it would be
clinically relevant to this
clinician type. This PRO-PM
would help to fill a gap for
patients receiving palliative
care by capturing the patient's
voice and experience of care by
assessing communication and
shared decision making with
the clinician. This is an
important patient-centered
measure that helps patients feel
heard and understood which
can effectively improve the
quality of care received and
outcomes for patients in
palliative care. Allowing
patients to feel heard and
understood adds an important
dimension to the care planning
for this unique patient
population commonly cared for
by clinicians in this specialty.
As more patients are living
longer with multiple
comorbidities, especially true
for the advanced heart disease
patient population, early
emergence of palliative care
into the overall care of cardiac
patients can notably improve
their quality oflife, patient
satisfaction, and reduction in
symptoms. 75 This measure is
predicated on existing
guidelines and conceptual
models76 and can facilitate and
improve effective patientclinician communication that
engenders trust,
acknowledgement, and a
whole-person orientation to the
care that is provided. Through
the benefits of enhanced
patient-provider
communication, this measure
would improve the quality of
care received and outcomes for
patients receiving palliative
care. The measure being added
to this specialty set would be
contingent on the inclusion of
applicable coding by the tin1e
of the CY 2025 PFS final rule.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62285
B.4a. Cardiology
Adult COVID19 Vaccination
Status:
77
78
TBD
NIA
MIPSCQM
Specifications
Process
Centers for
Medicare&
Medicaid
Services
See footnote lkeokwu et al., 2023 in Table B.l of this Appendix.
See footnotes Fitzpatrick et al., 2022; Polack et al., 2020; and Grana et al., 2022 in Table A.5 of this Appendix.
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Percentage of
patients aged 18
years and older
seen for a visit
during the
performance
period that are
up-to-date on
their COVTD-19
vaccinations as
defined by CDC
recommendation
son current
vaccination.
We are proposing to include
this measure in the Cardiology
specialty set as it would be
clinically relevant to this
clinician type. Widespread
vaccination against SARSCo V-2, the virus that causes
COVID-19, is critically
important to stemming the
morbidity and mortality caused
by this disease. 77 Clinicians are
uniquely positioned to
encourage uptake ofCOVID19 vaccination, and clinicians
are still a major driving force
in promoting patient
vaccination. The addition of
this quality measure in this
specialty set would help
strengthen compliance with
recommended COVTD-19
vaccination, leading to
improvement in the quality of
patient care and prevention of
disease for the general
population. This quality
measure aligns with clinical
guidelines and the evidencebased recommendations of the
ACTP, where there is general
agreement about the safety and
efficacy of the COVID-19
vaccine, preventing costly and
potentially harmful
hospitalizations. 78 Broadening
vaccination status awareness to
this clinician type is valuable
as it can help drive an increase
in the adult vaccination rates.
The COVJD-19 vaccination
included within this measure
would reduce the prevalence of
severe diseases that may be
associated with hospitalization
and decrease overall health
care costs. The measure being
added to this specialty set
would be contingent on the
inclusion ofapplicable coding
by the time of the CY 2025
PFS final rule. In the event
appropriate coding is not
included in the final
specification, this measure
would not be finalized for
inclusion within this specialty
measure set. See Table A.5 of
this Appendix for rationale,
including clinical evidence
supporting the inclusion of this
measure in MIPS.
62286
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
B.4b. Electrophysiology Cardiac Specialist
In addition to the considerations discussed in the introductory language of Table Group B of this Appendix to this proposed rule,
the Electrophysiology Cardiac Specialist specialty set takes additional criteria into consideration, which includes, but is not
limited to: whether a measure reflects current clinical guidelines, and the coding of the measure includes relevant clinician types.
We may reassess the appropriateness of individual measures, on a case-by-case basis, to ensure appropriate inclusion in the
specialty set. Measure tables in this set include previously finalized measures we are maintaining within the set, measures
proposed to be added, and measures proposed for removal, as applicable. We request comment on the measures available in the
proposed Electrophysiology Cardiac Specialist specialty set that have proposed substantive changes in Table Group D of this
Appendix as indicated by an * in the Indicator column.
B.4b. Electrophysiology Cardiac Specialist
PREVIOUSLY· FINALIZED MEA.SlJRJ,;S.IN THE
ELEtt~OPH.YSlOLOGY C:ARDIAC SPECIALlST SPEC:JA.LTY Sli:'f .• ..•·· ·...•
.
.
·.
:·: .·
•• :· :
•··
..
CBE#/ Quality·•.·.
CMS
Me!ls!lr
Measure Title
Collil~tion .
i\feasure Steward
··JudicMor
e<::QM
e
.
e<::Ql\:i
:••#. ,·:
!l.nd J).e$C)"q,tiort
..
ID • . • Typ~
. • •<:
.
(
. . . I\
Tvrie .ii.:
.·.
CBE#
I
§
!
(Outcome)
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!
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"'.
-,'."
·.'
• Submission Age Criteria 4: Males
65 years of age and older
Infection within 180 Days of
Cardiac Implantable Electronic
Device (C:IED) Implantation,
Replacement, or Revision:
Infection rate following CTED
device implantation, replacement,
or revision.
E:\FR\FM\31JYP2.SGM
31JYP2
:
American College
of Cardiology
Foundation
American College
of Cardiology
Foundation
EP31JY24.242
',.
Cardiac Tamponade and/or
Pericardiocentesis Following
Atrial Fibrillation Ablation:
Rate of cardiac tamponade and/or
pericardiocentesis following atrial
fibrillation ablation. This measure
is submitted as four rates stratified
by age and gender:
• Submission Age Criteria 1:
Females 18-64 years of age
• Submission Age Criteria 2: Males
18-64 years of age
• Submission Age Criteria 3:
Females 65 years of age and older
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62287
8.5. Certified Nurse Midwife
In addition to the considerations discussed in the introductory language of Table Group B of this Appendix to this proposed rule,
the Certified Nurse-Midwife specialty set takes additional criteria into consideration, which includes, but is not limited to:
whether a measure reflects current clinical guidelines, and the coding of the measure includes relevant clinician types. We may
reassess the appropriateness of individual measures, on a case-by-case basis, to ensure appropriate inclusion in the specialty set.
Measure tables in this set include previously finalized measures we are maintaining within the set, measures proposed to be
added, and measures proposed for removal, as applicable. We request comment on the measures available in the proposed
Certified Nurse Midwife specialty set that have proposed substantive changes in Table Group D of this Appendix as indicated by
an * in the Indicator column.
8.5. Certified Nurse-Midwife
!
(Care
Coordination)
0326 I
NIA
NIA
130
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vl4
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Specifications,
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Specifications
Process
CMS13
8v13
Medicare Part
B Claims
Measure
Specifications,
eCQM
Specifications,
MIPS CQM
Specifications
Process
NIA
MIPS CQM
Specifications
Outcome
*
§
!
NIAi
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(Patient
Safety)
§
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National
Committee for
Quality Assurance
Centers for
Medicare &
Medicaid Services
National
Committee for
Quality Assurance
Centers for
Medicare &
Medicaid Services
EP31JY24.243
047
Medicare Part
B Claims
Measure
Specifications,
MIPS CQM
Specifications
*
Advance Care Plan:
Percentage of patients aged 65
years and older who have an
advance care plan or surrogate
decision maker documented in the
medical record or documentation in
the medical record that an advance
care plan was discussed but the
patient did not wish or was not able
to name a surrogate decision maker
or rovide an advance care Ian.
Documentation of Current
Medications in the Medical
Record:
Percentage of visits for patients
aged 18 years and older for which
the eligible clinician attests to
documenting a list of current
medications using all immediate
resources available on the date of
the encounter.
Preventive Care and Screening:
Tobacco Use: Screening and
Cessation Intervention:
Percentage of patients aged 12
years and older who were screened
for tobacco use one or more times
during the measurement period
AND who received tobacco
cessation intervention during the
measurement period or in the six
months prior to the measurement
period if identified as a tobacco
user.
Maternity Care: Elective
Delivery (Without Medical
Indication) at< 39 Weeks
(Overuse):
Percentage of patients, regardless
of age, who gave birth during a 12month period, delivered a live
singleton at < 39 weeks of
gestation, and had elective
deliveries (without medical
indication) by cesarean birth or
induction of labor.
62288
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B.5. Certified Nurse-Midwife
§
NIAi
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336
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Specifications
Process
2152 I
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431
NIA
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Specifications
Process
§
NIAi
NIA
475
CMS34
9v7
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Specifications
!
NIAi
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487
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Specifications
Process
NIA I
NIA
496
NIA
MIPS CQM
Specifications
Process
!
(Care
Coordination)
§
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Centers for
Medicare &
Medicaid Services
National
Committee for
Quality Assurance
Centers for
Disease Control
and Prevention
Centers for
Medicare &
Medicaid Services
University of
California, Irvine
EP31JY24.244
*
Maternity Care: Postpartum
Follow-up and Care
Coordination:
Percentage of patients, regardless
of age, who gave birth during a 12month period who were seen for
postpartum care before or at 12
weeks of giving birth and received
the following at a postpartum visit:
breast-feeding evaluation and
education, postpartum depression
screening, postpartum glucose
screening for gestational diabetes
patients, family and contraceptive
planning counseling, tobacco use
screening and cessation education,
healthy lifestyle behavioral advice,
and an immunization review and
u date.
Preventive Care and Screening:
Unhealthy Alcohol Use: Screening
& Brief Counseling:
Percentage of patients aged 18
years and older who were screened
for unhealthy alcohol use using a
systematic screening method at
least once within the last 12 months
AND who received brief
counseling if identified as an
unhealth alcohol user.
HIV Screening:
Percentage of patients aged 15-65
at the start of the measurement
period who were between 15-65
years old when tested for Human
Immunodeficienc Virus HIV).
Screening for Social Drivers of
Health:
Percent of patients 18 years and
older screened for food insecurity,
housing instability, transportation
needs, utility difficulties, and
inter ersonal safe
Cardiovascular Disease
(CVD) Risk Assessment
Measure - Proportion of
Pregnant/Postpartum Patients
that Receive CVD Risk
Assessment with a Standardized
Instrument: Percentage of
pregnant or postpartum patients
who received a cardiovascular
disease (CVD) risk assessment with
a standardized instrument.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62289
B.5. Certified Nurse-Midwife
*
!
(Equity)
*
!
(Outcome)
!
(Safety)
*
!
498
NIA
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Specifications
Process
PatientReported
OutcomeBased
Performan
ce
Measure
2483 I
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503
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Specifications
NIAi
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504
NIA
MIPSCQM
Specifications
Process
MIPSCQM
Specifications
PatientReported
OutcomeBased
Performan
ce
Measure
NIAi
NIA
505
NIA
OCHIN
Insignia Health,
LLC, a wholly
owned subsidiary
of Phreesia
American
Psychiatric
Association
American
Psychiatric
Association
B.6. Chiropractic Medicine
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Connection to Community
Service Provider:
Percent of patients I 8 years or older
who screen positive for one or more
of the following health related
social needs (HRSNs): food
insecurity, housing instability,
transportation needs, utility help
needs, or interpersonal safety; and
had contact with a Community
Service Provider (CSP) for at least
l of their HRSNs within 60 days
after screenin .
Gains in Patient Activation
Measure (PAM®) Scores at 12
Months:
The Patient Activation Measure®
(PAM®) is a 10-or 13 - item
questionnaire that assesses an
individual's knowledge, skills and
confidence for managing their
health and health care. The measure
assesses individuals on a 0-100
scale that converts to one of four
levels of activation, from low ( l) to
high (4). The PAM® performance
measure (PAM®-PM) is the change
in score on the PAM® from
baseline to follow-u measurement.
Initiation, Review, And/Or
Update To Suicide Safety Plan
For Individuals With Suicidal
Thoughts, Behavior, Or Suicide
Risk:
Percentage of adult aged 18 years
and older with suicidal ideation or
behavior symptoms (based on
results of a standardized assessment
tool or screening tool) or increased
suicide risk (based on the
clinician's evaluation or clinicianrating tool) for whom a suicide
safety plan is initiated, reviewed,
and/or updated in collaboration
between the patient and their
clinician.
Reduction in Suicidal Ideation or
Behavior Symptoms:
The percentage of patients aged 18
and older with a mental and/or
substance use disorder AND
suicidal thoughts, behaviors or risk
symptoms who demonstrated a
reduction in suicidal ideation and/or
behavior symptoms based on
results from the Columbia-Suicide
Severity Rating Scale (C-SSRS)
'Screen Version' or 'Since Last
Visit' within 120 days after an
index assessment.
62290
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
In addition to the considerations discussed in the introductory language of Table Group B of this Appendix to this proposed rule,
the Chiropractic Medicine specialty set takes additional criteria into consideration, which includes, but is not limited to: whether
a measure reflects current clinical guidelines, and the coding of the measure includes relevant clinician types. We may reassess
the appropriateness of individual measures, on a case-by-case basis, to ensure appropriate inclusion in the specialty set. Measure
tables in this set include previously finalized measures we are maintaining within the set, measures proposed to be added, and
measures proposed for removal, as applicable. We request comment on the measures available in the proposed Chiropractic
Medicine specialty set that have proposed substantive changes in Table Group D of this Appendix as indicated by an* in the
Indicator column.
B.6. Chiropractic Medicine
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Outcomes,
Inc.
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Outcomes,
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Inc.
EP31JY24.246
*
Functional Outcome Assessment:
Percentage of visits for patients aged 18
years and older with documentation of a
current functional outcome assessment
using a standardized functional outcome
assessment tool on the date of the
encounter AND documentation of a care
plan based on identified functional
outcome deficiencies within 2 days of the
date of the identified deficiencies.
Functional Status Change for Patients
with Knee Impairments:
A patient-reported outcome measure
(PROM) of risk-adjusted change in
functional status (FS) for patients 14
years+ with knee impairments. The
change in FS is assessed using the FOTO
Lower Extremity Physical Function
(LEPF) PROM. The measure is adjusted
to patient characteristics known to be
associated with FS outcomes (riskadjusted) and used as a performance
measure at the patient, individual
clinician, and clinic levels to assess
uali
Functional Status Change for Patients
with Hip Impairments:
A patient-reported outcome measure
(PROM) ofrisk-adjusted change in
functional status (FS) for patients 14
years+ with hip impairments. The change
in FS is assessed using the FOTO Lower
Extremity Physical Function (LEPF)
PROM. The measure is adjusted to patient
characteristics known to be associated
with FS outcomes (risk adjusted) and used
as a performance measure at the patient,
individual clinician, and clinic levels to
assess uali
Functional Status Change for Patients
with Lower Leg, Foot or Ankle
Impairments:
A patient-reported outcome measure
(PROM) ofrisk-adjusted change in
functional status (FS) for patients I4
years+ with foot, ankle or lower leg
impairments. The change in FS is assessed
using the FOTO Lower Extremity
Physical Function (LEPF) PROM. The
measure is adjusted to patient
characteristics known to be associated
with FS outcomes (risk-adjusted) and used
as a performance measure at the patient,
individual clinician, and clinic levels to
assess uali •.
62291
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8.6. Chiropractic Medicine
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(Outcome)
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(Outcome)
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Outcomes,
Inc.
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Therapeutic
Outcomes,
Inc.
Focus on
Therapeutic
Outcomes,
Inc.
Focus on
Therapeutic
Outcomes,
Inc.
Centers for
Medicare &
Medicaid
Services
EP31JY24.247
!
Functional Status Change for Patients
with Low Back Impairments:
A patient-reported outcome measure
(PROM) of risk-adjusted change in
functional status (FS) for patients 14
years+ with low back impairments. The
change in FS is assessed using the FOTO
Low Back FS PROM. The measure is
adjusted to patient characteristics known
to be associated with FS outcomes (risk
adjusted) and used as a performance
measure at the patient, individual
clinician, and clinic levels to assess
uali
Functional Status Change for Patients
with Shoulder Impairments:
A patient-reported outcome measure
(PROM) of risk-adjusted change in
functional status (FS) for patients 14
years+ with shoulder impairments. The
change in FS is assessed using the FOTO
Shoulder FS PROM. The measure is
adjusted to patient characteristics known
to be associated with FS outcomes (risk
adjusted) and used as a performance
measure at the patient, individual
clinician, and clinic levels to assess
ualit .
Functional Status Change for Patients
with Elbow, Wrist or Hand
Impairments:
A patient-reported outcome measure
(PROM) of risk-adjusted change in
functional status (FS) for patients 14
years+ with elbow, wrist, or hand
impairments. The change in FS is assessed
using the FOTO Elbow/Wrist/Hand FS
PROM. The measure is adjusted to patient
characteristics known to be associated
with FS outcomes (risk adjusted) and used
as a performance measure at the patient,
individual clinician, and clinic levels to
assess uali
Functional Status Change for Patients
with Neck Impairments:
A patient-reported outcome measure
(PROM) ofrisk-adjusted change in
functional status (FS) for patients 14
years+ with neck impairments. The
change in FS is assessed using the FOTO
Neck FS PROM. The measure is adjusted
to patient characteristics known to be
associated with FS outcomes (riskadjusted) and used as a performance
measure at the patient, individual
clinician, and clinic levels to assess
uali
Screening for Social Drivers of Health:
Percent of patients 18 years and older
screened for food insecurity, housing
instability, transportation needs, utility
difficulties, and inter ersonal safe! .
62292
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
B.6. Chiropractic Medicine
JZED MEASURES IN THE. CHIR
Measur~
Tyr:>e
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OCHIN
EP31JY24.248
*
Connection to Community Service
Provider:
Percent of patients 18 years or older who
screen positive for one or more of the
following health related social needs
(HRSNs): food insecurity, housing
instability, transportation needs, utility
help needs, or interpersonal safety; and
had contact with a Community Service
Provider (CSP) for at least 1 of their
HRSNs within 60 da s after screenin
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62293
B.7. Clinical Social Work
In addition to the considerations discussed in the introductory language of Table Group B of this Appendix to this proposed rule,
the Clinical Social Work specialty set takes additional criteria into consideration, which includes, but is not limited to: whether a
measure reflects current clinical guidelines, and the coding of the measure includes relevant clinician types. We may reassess the
appropriateness of individual measures, on a case-by-case basis, to ensure appropriate inclusion in the specialty set. Measure
tables in this set include previously finalized measures we are maintaining within the set, measures proposed to be added, and
measures proposed for removal, as applicable. We request comment on the measures available in the proposed Clinical Social
Work specialty set.
B.7. Clinical Social Work
!
(Care
Coordination
)
0326 I
NIA
NIA
130
CMS68
vl4
eCQM
Specifications,
MIPS CQM
Specifications
Process
CMS2v
14
Medicare Part
B Claims
Measure
Specifications,
eCQM
Specifications,
MIPS CQM
Specifications
Process
NIA
Medicare Part
B Claims
Measure
Specifications,
MIPS CQM
Specifications
Process
*
§
!
(Patient
Safety)
§
NIAi
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*
!
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National
Committee for
Qua] ity Assurance
Centers for
Medicare &
Medicaid Services
Centers for
Medicare &
Medicaid Services
Centers for
Medicare &
Medicaid Services
EP31JY24.249
047
Medicare Part
B Claims
Measure
Specifications,
MIPS CQM
Specifications
*
Advance Care Plan:
Percentage of patients aged 65
years and older who have an
advance care plan or surrogate
decision maker documented in
the medical record or
documentation in the medical
record that an advance care plan
was discussed but the patient did
not wish or was not able to name
a surrogate decision maker or
rovide an advance care Ian.
Documentation of Current
Medications in the Medical
Record:
Percentage of visits for patients
aged 18 years and older for
which the eligible clinician
attests to documenting a list of
current medications using all
immediate resources available on
the date of the encounter.
Preventive Care and
Screening: Screening for
Depression and Follow-Up
Plan:
Percentage of patients aged 12
years and older screened for
depression on the date of the
encounter or up to 14 days prior
to the date of the encounter using
an age-appropriate standardized
depression screening tool AND if
positive, a follow-up plan is
documented on the date of or up
to two days after the date of the
uali in encounter.
Elder Maltreatment Screen
and Follow-lip Plan:
Percentage of patients aged 60
years and older with a
documented elder maltreatment
screen using an Elder
Maltreatment Screening tool on
the date of encounter AND a
documented follow-up plan on
the date of the ositive screen.
62294
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
B.7. Clinical Social Work
*
*
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CMS13
8vl3
NIAi
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281
CMS14
9vl3
eCQM
Specifications
NIAi
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282
NIA
MIPS CQM
Specifications
Process
Process
Process
*
!
(Patient
Safety)
NIAi
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NIA
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Specifications
Process
*
!
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National
Committee for
Qua] ity Assurance
American
Academy of
Neurology
American
Academy of
Neurology/
American
Psychiatric
Association
American
Psychiatric
Association/
American
Academy of
Neurology
American
Academy of
Neurology/
American
Psychiatric
Association
EP31JY24.250
§
Medicare Part
B Claims
Measure
Specifications,
eCQM
Specifications,
MIPS CQM
Specifications
Preventive Care and
Screening: Tobacco Use:
Screening and Cessation
Intervention:
Percentage of patients aged 12
years and older who were
screened for tobacco use one or
more times during the
measurement period AND who
received tobacco cessation
intervention during the
measurement period or in the six
months prior to the measurement
period if identified as a tobacco
user.
Dementia: Cognitive
Assessment:
Percentage of patients, regardless
of age, with a diagnosis of
dementia for whom an
assessment of cognition is
performed and the results
reviewed at least once within a
12-month eriod.
Dementia: Functional Status
Assessment:
Percentage of patients with
dementia for whom an
assessment of functional status
was performed at least once in
the last 12 months.
Dementia: Safety Concern
Screening and Follow-Up for
Patients with Dementia:
Percentage of patients with
dementia or their caregiver(s) for
whom there was a documented
safety concerns screening in two
domains of risk: I)
dangerousness to self or others
and 2) environmental risks; and
if safety concerns screening was
positive in the last 12 months,
there was documentation of
mitigation recommendations,
including but not limited to
referral to other resources.
Dementia: Education and
Support of Caregivers for
Patients with Dementia:
Percentage of patients with
dementia whose caregiver(s)
were provided with education on
dementia disease management
and health behavior changes
AND were referred to additional
resources for support in the last
12 months.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62295
B.7. Clinical Social Work
Indicator
!
(Opioid)
§
!
(Outcome)
!
(Patient
Safety)
*
§
!
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PREVIOUSLY FINALIZED MEASURES IN THE CLINICAL SOCIAL WORK SPECIALTY SET
CSE#
CMS
Quality
I
Collection
Measure
.Measure Title
eCQM
Measure Steward
#
Type
Type
eCQM
and Description
ID
CBE#
.·
Initiation and Engagement of
Substance Use Disorder
Treatment:
Percentage of patients 13 years
of age and older with a new
substance use disorder (SUD)
episode who received the
following (Two rates are
reported):
a. Percentage of patients who
initiated treatment, including
National
NIAi
CMSl3
eCQM
Process
either an intervention or
Committee for
305
NIA
Specifications
7v13
medication for the treatment of
Quality Assurance
SUD, within 14 days of the new
SUD episode.
b. Percentage of patients who
engaged in ongoing treatment,
including two additional
interventions or medication
treatment events for SUD, or one
long-acting medication event for
the treatment of SUD, within 34
days of the initiation.
Depression Remission at
Twelve Months:
The percentage of adolescent
eCQM
Minnesota
patients 12 to 17 years of age and
CMS15
Specifications,
0710 I
Outcome
adult patients 18 years of age or
Community
370
MIPS CQM
0710e
9vl3
older with major depression or
Measurement
Specifications
dysthymia who reached
remission 12 months (+I- 60
days) after an index event date.
Child and Adolescent Major
Depressive Disorder (MOD):
Suicide Risk Assessment:
Percentage of patient visits for
CMS17 eCQM
those patients aged 6 through 16
NIAi
Mathematica
382
Process
NIA
7vl3
Specifications
years at the start of the
measurement period with a
diagnosis of major depressive
disorder (MDD) with an
assessment for suicide risk.
Adherence to Antipsychotic
Medications for Individuals
with Schizophrenia:
Percentage of individuals at least
18 years of age as of the
beginning of the performance
Centers for
MIPS CQM
1879 I
Intermediate period with schizophrenia or
NIA
Medicare &
383
NIA
Specifications
Outcome
schizoaffective disorder who had
Medicaid Services
at least two prescriptions filled
for any antipsychotic medication
and who had a Proportion of
Days Covered (PDC) of at least
0.8 for antipsychotic medications
during the performance period.
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62296
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B.7. Clinical Social Work
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!
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Specifications
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OutcomeBased
Performance
Measure
(Safety)
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National
Committee for
Quality Assurance
Centers for
Medicare &
Medicaid Services
OCHIN
American
Psychiatric
Association
American
Psychiatric
Association
EP31JY24.252
§
Preventive Care and Screening:
Unhealthy Alcohol Use:
Screening & Brief Connseling:
Percentage of patients aged 18
years and older who were
screened for unhealthy alcohol
use using a systematic screening
method at least once within the
last 12 months AND who
received briefcounseling if
identified as an unhealthy alcohol
user.
Screening for Social Drivers of
Health:
Percent of patients 18 years and
older screened for food insecurity,
housing instability, transportation
needs, utility difficulties, and
inte ersonal safe
Connection to Community
Service Provider:
Percent of patients 18 years or
older who screen positive for one
or more of the following health
related social needs (HRSNs):
food insecurity, housing
instability, transportation needs,
utility help needs, or
interpersonal safety; and had
contact with a Community
Service Provider (CSP) for at
least l of their HRSNs within 60
da s after screenin .
Improvement or Maintenance
of Fnnctioning for Individuals
with a Mental and/or
Substance Use Disorder:
The percentage of patients aged
18 and older with a mental and/or
substance use disorder who
demonstrated improvement or
maintenance of functioning
based on results from the 12-item
World Health Organization
Disability Assessment Schedule
(WHODAS 2.0) or Sheehan
Disability Scale (SDS) 30 to 180
da s after an index assessment.
Initiation, Review, And/Or
Update To Suicide Safety Plan
For Individuals With Suicidal
Thoughts, Behavior, Or
Suicide Risk: Percentage of
adult aged 18 years and older
with suicidal ideation or behavior
symptoms (based on results of a
standardized assessment tool or
screening tool) or increased
suicide risk (based on the
clinician's evaluation or
clinician-rating tool) for whom a
suicide safety plan is initiated,
reviewed, and/or updated in
collaboration between the patient
and their clinician.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62297
B.7. Clinical Social Work
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American
Psychiatric
Association
EP31JY24.253
*
Reduction in Suicidal Ideation
or Behavior Symptoms: The
percentage of patients aged 18
and older with a mental and/or
substance use disorder AND
suicidal thoughts, behaviors or
risk symptoms who demonstrated
a reduction in suicidal ideation
and/or behavior symptoms based
on results from the ColumbiaSuicide Severity Rating Scale (CSSRS) 'Screen Version' or
'Since Last Visit' within 120
da s atler an index assessment.
62298
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
8.7. Clinical Social Work
Gains in Patient
Activation
Measure (PAM
®) Scores at 12
Months:
24831
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)
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MlPS
CQM
Specificati
ons
PatientReported
OutcomeBased
Performanc
eMeasure
The Patient
Activation
Measure® (PAM
®) is a 10- or 13item
questionnaire
that assesses an
individual's
knowledge, skills
and confidence
for managing
their health and
health care. The
measure assesses
individuals on a
0-100 scale that
converts to one
of four levels of
activation, from
low(l)to high
(4). The PAM®
performance
measure
(PAM®-PM) is
the change in
score on the
PAM®from
baseline to
follow-up
measurement.
Insignia
Health,
LLC,a
wholly
owned
subsidiary of
Phreesia
We are proposing to include
this measure in the Clinical
Social Work specialty set as it
would be clinically relevant to
this clinician type. The addition
of this measure to this specialty
set would be feasible given its
use through the continuum of
care and across different
clinical settings. This measure
addresses chronic conditions
and outcomes, both of which
are high priority areas for
measure consideration for
MlPS. It is utilized in research
within the U.S. and
internationally and has also
been shown to be valid and
reliable in different clinical
settings and under different
payment models. 79 The
measure being added to this
specialty set would be
contingent on the inclusion of
applicable coding by the time
of the CY 2025 PFS final rule.
Phreesia. (2024). Patient Activation Measure (PAM). https://www.phreesia.com/patient-activationmeasure/?utm_source=google&utm_%20medium=paid_%20search&utm_%20destinationmedium=mql_form&ut
m_ca mpa ign=payer_care_management_paid_ search&utm _vendor=phreesia&utm_audience l=payer&utm _ conte
nt=648172611574&utm_destinationco.
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62299
B.8. Dentistry
In addition to the considerations discussed in the introductory language of Table Group B of this Appendix to this proposed rule,
the Dentistry specialty set takes additional criteria into consideration, which includes, but is not limited to: whether a measure
reflects current clinical guidelines, and the coding of the measure includes relevant clinician types. We may reassess the
appropriateness of individual measures, on a case-by-case basis, to ensure appropriate inclusion in the specialty set. Measure
tables in this set include previously finalized measures we are maintaining within the set, measures proposed to be added, and
measures proposed for removal, as applicable. This specialty set has no proposed changes.
B.8. Dentistry
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Centers for Medicare
& Medicaid Services
Centers for Medicare
& Medicaid Services
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(Outcome)
Children Who Have Dental
Decay or Cavities:
Percentage ofchildren, 1 - 20 years
of age at the start of the
measurement period, who have had
tooth decay or cavities during the
measurement period as determined
b a dentist.
Primary Caries Prevention
Intervention as Offered by
Dentists:
Percentage of children, 1 - 20 years
of age, who received two fluoride
varnish applications during the
measurement period as determined
b a dentist.
62300
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
B.9. Dermatology
In addition to the considerations discussed in the introductory language of Table Group B of this Appendix to this proposed rule,
the Dermatology specialty set takes additional criteria into consideration, which includes. but is not limited to: whether a measure
reflects current clinical guidelines, and the coding of the measure includes relevant clinician types. We may reassess the
appropriateness of individual measures, on a case-by-case basis, to ensure appropriate inclusion in the specialty set. Measure
tables in this set include previously finalized measures we are maintaining within the set, measures proposed to be added, and
measures proposed for removal, as applicable. We request comment on the measures available in the proposed Dermatology
specialty set.
B.9. Dermatology
§
!
(Patient
Safety)
*
§
NIAi
NIA
NIAi
NIA
NIAi
NIA
130
CMS68
v14
eCQM
Specifications,
MIPSCQM
Specifications
Process
176
NIA
MIPSCQM
Specifications
Process
CMS13
8v13
Medicare Part
B Claims
Measure
Specifications,
eCQM
Specifications,
MIPSCQM
Specifications
Process
Medicare Part
B Claims
Measure
Specifications,
eCQM
Specifications,
MIPSCQM
Specifications
Process
eCQM
Specifications.
MIPSCQM
Specifications
Process
226
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Centers for
Medicare &
Medicaid Services
American College
ofRheumatology
National
Committee for
Qua! ity Assurance
Centers for
Medicare &
Medicaid Services
Centers for
Medicare &
Medicaid Services
EP31JY24.256
*
Documentation of Current
Medications in the Medical
Record:
Percentage of visits for patients
aged 18 years and older for which
the eligible clinician attests to
documenting a list ofcurrent
medications using all immediate
resources available on the date of
the encounter.
Tuberculosis Screening Prior to
:First Course of Biologic and/or
Immune Response Modifier
Therapy:
Ifa patient has been newly
prescribed a biologic and/or
immune response modifier that
includes a warning for potential
reactivation of a latent infection,
then the medical record should
indicate TB testing in the preceding
12-month eriod.
Preventive Care and Screening:
Tobacco Use: Screening and
Cessation Intervention:
Percentage of patients aged 12
years and older who were screened
for tobacco use one or more times
during the measurement period
AND who received tobacco
cessation intervention during the
measurement period or in the 6
months prior to the measurement
period if identified as a tobacco
user.
Preventive Care and Screening:
Screening for High Blood
Pressure and Follow-Up
Documented:
Percentage of patient visits for
patients aged 18 years and older
seen during the measurement
period who were screened for high
blood pressure AND a
recommended follow-up plan is
documented, as indicated, if blood
pressure is elevated or
hy ertensive.
Closing the Referral Loop:
Receipt of Specialist Report:
Percentage of patients with
referrals, regardless of age, for
which the referring clinician
receives a report from the clinician
to whom the atient was referred.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
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B.9. Dermatology
!
(Care
Coordinatio
n)
•
!
(Outcome)
•
!
(Outcome)
!
(Equity)
*
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VerDate Sep<11>2014
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NIA
410
NIA
M!PSCQM
Specifications
Outcome
NIAi
NIA
440
NIA
MIPS CQM
Specifications
Process
M!PSCQM
Specifications
PatientReported
Outcome
-Based
Performa
nee
Measure
MfPSCQM
Specifications
PatientReported
Outcome
-Based
Performa
nee
Measure
NIAi
NIA
485
NIA
NIAi
NIA
486
NIA
NIAi
NIA
487
NIA
MIPSCQM
Specifications
Process
NIAi
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498
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Process
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American
Academy of
Dermatology
American
Academy of
Dermatology
American
Academy of
Dermatology
American
Academy of
Dermatology
Centers for
Medicare &
Medicaid Services
OCHTN
EP31JY24.257
!
(Outcome)
Psoriasis: Clinical Response to
Systemic Medications:
Percentage of psoriasis vulgaris
patients receiving systemic
medication who meet minimal
physician-or patient- reported
disease activity levels. It is implied
that establishment and maintenance
ofan established minimum level of
disease control as measured by
physician-and/or patient-reported
outcomes will increase patient
satisfaction with and adherence to
treatment.
Skin Cancer: Biopsy Reporting
Time - Pathologist to Clinician:
Percentage of biopsies with a
diagnosis of cutaneous basal cell
carcinoma (BCC) and squamous
cell carcinoma (SCC), or melanoma
(including in situ disease) in which
the pathologist communicates
results to the clinician within 7 days
from the time when the tissue
specimen was received by the
atholo ist.
·Psoriasis - Improvement in
Patient-Reported Itch Severity:
The percentage of patients, aged 8
years and older, with a diagnosis of
psoriasis where at an initial (index)
visit have a patient reported itch
severity assessment performed,
score greater than or equal to four,
and who achieve a score reduction
of three or more points at a follow
U visit.
Dermatitis - Improvement in
Patient-Reported Itch Severity:
The percentage of patients, aged 8
years and older, with a diagnosis of
dermatitis where at an initial
(index) visit have a patient reported
itch severity assessment performed,
score greater than or equal to 4, and
who achieve a score reduction of 3
or more oints at a follow u visit.
Screening for Social Drivers of
Health:
Percent of patients 18 years and
older screened for food insecurity,
housing instability, transportation
needs, utility ditricu !ties, and
inter ersonal safet .
Connection to Community
Service Provider:
Percent of patients 18 years or older
who screen positive for one or more
of the following health related
social needs (HRSNs ): food
insecurity, housing instability,
transportation needs, utility help
needs, or interpersonal safety; and
had contact with a Community
Service Provider (CSP) for at least
1 of their IIRSNs within 60 days
after screenin
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B.9. Dermatology
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Insignia Health,
LLC, a wholly
owned subsidiary
of Phreesia
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!
(Outcome)
24831
PatientReported
Outcome
-Based
Performa
nee
Measure
Gains in Patient Activation
Measure (PAM®) Scores at 12
Months:
The Patient Activation Measure®
(PAM®) is a 10- or 13 - item
questionnaire that assesses an
individual's knowledge, skills and
confidence for managing their
health and health care. The measure
assesses individuals on a 0-100
scale that converts to one of four
levels of activation, from low ( 1) to
high (4). The PAM® performance
measure (PAM®-PM) is the change
in score on the PAM® from
baseline to follow-u measurement.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
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B.9. Dermatology
!
(Care
Coordinatio
n)
NIAi
NIA
TBD
NIA
MIPS
CQM
Specificati
ons
Process
Melanoma:
Tracking and
Evaluation of
Recurrence:
Percentage of
patients who had
an excisional
surgery for
melanoma or
melanoma in situ
with initial
American Joint
Committee on
Cancer (AJCC)
staging of 0, I, or
II in the past S
years in which
the operating
provider
examines and/or
diagnoses the
patient for
recurrence of
melanoma.
American
Academy
of
Dermatol
ogy
We are proposing to include this
measure in the Dermatology
specialty set as it would be
clinically relevant to this clinician
type. Clinicians within this
specialty care for patients
diagnosed with melanoma and are
most likely to be the clinician to
evaluate the frequency of
melanoma recurrence following
excisional procedures for this
patient population. 80 This measure
addresses the CMS high priority
outcome for care coordination, as
a lack of communication has been
recognized between the excising
clinician and clinician continuing
care. This measure would allow
for the development of a system in
which melanomas can be
accurately tracked to increase the
understanding of the effectiveness
of care. The incorporation of this
measure in this specialty set
would help promote
communications between the
dermatologist treating the
melanoma and the clinicians
continuing care. Melanoma
recurrence is an outcome that
needs precise evaluation. 81 The
measure being added to this
specialty set would be contingent
on the inclusion of applicable
coding by the time of the CY
2025 PFS final rule. See Table
A.6 of this Appendix for rationale,
including clinical evidence
supporting the inclusion of this
measure in MIPS.
Rebecca, V. W., Sondak, V. K., & Smalley, K. S. (2012). A Brief History of Melanoma: From Mummies to
Mutations. Melanoma Research, 22(2), 114-122. https://doi.org/10.1097/CMR.0b013e328351fa4d.
81 Freeman, M., & Laks, S. (2019). Surveillance Imaging for Metastasis in High-Risk Melanoma: Importance in
Individualized Patient Care and Survivorship. Melanoma Management, 6(1), MMT12.
https://doi.org/10.2217/mmt-2019-0003.
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B.9. Dermatology
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PREVIOUSLY FINALIZED MEASURES PROPOSED FOR REMOVAL FROM THE DERMATOLOGY SPECIALTV SET
Note:.Tn this proposed rule, we are proposing the removal of the followingmeasure(s) below fro111 thi.s specific specialty measure set based
upon u:view of updates made to existing quality measure specifications, the proposed addition ofnew measures for inclusion in MlPS, and the
feedb1tck provided b sbecialtv societies:
CBE.#
CMS
Measure
I
Quality
Collection
Measure Title
Measure
eCQM
Rationale for Removal
Type
..
Type
And Description
Steward
eCQM
#
m
CBE#
·.
Melanoma: Continuity of
This measure is being
Care - Recall System:
proposed for removal
Percentage of patients,
beginning with the CY
2025 performance
regardless of age, with a
current diagnosis of
periodl2027 MIPS
melanoma or a history of
payment year. See Table
melanoma whose
Group C for rationale.
information was entered, at
least once within a 12American
NIAi
MIPS CQM
month period, into a recall
Structure
Academy of
137
NIA
NIA
Specifications
system that includes:
Dermatology
• A target date for the next
complete physical skin
exam,AND
• A process to follow up
with patients who either did
not make an appointment
within the specified
timeframe or who missed a
scheduled appointment
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62305
8.10. Diagnostic Radiology
In addition to the considerations discussed in the introductory language of Table Group B of this Appendix to this proposed rule,
the Diagnostic Radiology specialty set takes additional criteria into consideration, which includes, but is not limited to: whether a
measure reflects current clinical guidelines, and the coding of the measure includes relevant clinician types. We may reassess the
appropriateness of individual measures, on a case-by-case basis, to ensure appropriate inclusion in the specialty set. Measure
tables in this set include previously finalized measures we are maintaining within the set, measures proposed to be added, and
measures proposed for removal, as applicable. As indicated in the Table Group B introduction, measure Q494 has been added to
the previously finalized measure set below and measure Q436 has been removed under this proposed rule as previously finalized
through the CY 2024 PFS final rule (88 FR 79556 through 79560 and 88 FR 79896). We request comment on the measures
available in the proposed Diagnostic Radiology specialty set that have proposed substantive changes in Table Group D of this
Appendix as indicated by an * in the Indicator column.
8.10. Diagnostic Radiology
(Patient
Safety)
NIAi
NIA
145
NIA
Medicare Part
B Claims
Measure
Specifications,
MIPS CQM
S ecifications
NIAi
NIA
360
NIA
MIPS CQM
Specifications
Process
NIAi
NIA
364
NIA
MIPS CQM
Specifications
Process
Process
*
!
(Appropriate
Use)
!
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Radiology: Exposure Dose
ludices Reported for
Procedures Using Fluoroscopy:
Final reports for procedures using
fluoroscopy that document
radiation ex osure indices.
Optimizing Patient Exposure to
Ionizing Radiation: Count of
Potential High Dose Radiation
Imaging Studies: Computed
Tomography (CT) and Cardiac
Nuclear Medicine Studies:
Percentage of computed
tomography (CT) and cardiac
nuclear medicine (myocardial
perfusion studies) imaging
reports for all patients, regardless
of age, that document a count of
known previous CT (any type of
CT) and cardiac nuclear medicine
(myocardial perfusion) studies
that the patient has received in
the 12-month period prior to the
current stud .
Optimizing Patient Exposure to
Ionizing Radiation:
Appropriateness: Follow-up
CT Imaging for Incidentally
Detected Pulmonary Nodules
According to Recommended
Guidelines:
Percentage of final reports for CT
imaging studies with a finding of
an incidental pulmonary nodule
for patients aged 35 years and
older that contain an impression
or conclusion that includes a
recommended interval and
modality for follow-up (e.g., type
of imaging or biopsy) or for no
follow-up, and source of
recommendations (e.g.,
guidelines such as Fleischner
Society, American Lung
Association, American College
of Chest Ph sicians).
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American College of
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American College of
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American College of
Radiology
EP31JY24.261
!
62306
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B.10. Diagnostic Radiology
PREVJOlJSLY FINALIZED MEASURES...lNTll:tOIAGNOSTIC
RAOIOLOGY
SPECIALTY.SET
.
..
CBE.#
I
. Jndicator .· • . eCQM·
.
·.·.
!
(Appropriate
Use)
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..•
.·
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406
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eCQM
\
.•
m.
Collett1t;1n
Type
'Me~s11re.
Type
..·
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••··
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Measure Title
.
•~it~ 1-)!)si:riptitjn
·.
31JYP2
..·
Measure Steward
.
Appropriate Follow-up
Imaging for Incidental
Abdominal Lesions:
Percentage of final reports for
imaging studies for patients aged
18 years and older with one or
more of the following noted
incidentally with a specific
recommendation for no followup imaging recommended based
on radiological findings:
• Cystic renal lesion that is
simple appearing* (Bosniak I or
11)
• Adrenal lesion less than or
equal to LO cm
• Adrenal lesion greater than 1.0
cm but less than or equal to 4.0
cm classified as likely benign or
diagnostic benign by unenhanced
CT or washout protocol CT, or
MRI with in- and opposed-phase
sequences or other equivalent
institutional imaging protocols
Appropriate Follow-Up
Imaging for Incidental Thyroid
Nodules in Patients:
Percentage of final reports for
computed tomography (CT), CT
angiography (CTA) or magnetic
resonance imaging (MRI) or
magnetic resonance angiogram
(MRA) studies of the chest or
neck for patients aged 18 years
and older with no known thyroid
disease with a thyroid nodule <
LO cm noted incidentally with
follow-up imaging
recommended.
E:\FR\FM\31JYP2.SGM
·•.
.
American College of
Radiology
American College of
Radiology
EP31JY24.262
•.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
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B.10. Diagnostic Radiology
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Outcome
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Alara Imaging, Inc.
in collaboration with
the University of
California, San
Francisco (UCSF)
EP31JY24.263
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!
(Outcome)
Excessive Radiation Dose or
Inadequate Image Quality for
Diagnostic Computed
Tomography (CT) in Adults
(Clinician Level):
This measure provides a
standardized method for
monitoring the performance of
diagnostic CT to discourage
unnecessarily high radiation
doses, a risk factor for cancer,
while preserving image quality. It
is expressed as a percentage of
patients with CT exams that are
out-of-range based on having
either excessive radiation dose or
inadequate image quality relative
to evidence-based thresholds
based on the clinical indication
for the exam. All diagnostic CT
exams of specified anatomic sites
performed in inpatient, outpatient
and ambulatory care settings are
eligible. This measure is not
telehealth eligible. This eCQM
requires the use of additional
software to access primary data
elements stored within radiology
electronic health records and
translate them into data elements
that can be ingested by this
eCQM. Additional details are
included in the Guidance field.
62308
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
B.11. Emergency Medicine
In addition to the considerations discussed in the introductory language of Table Group B of this Appendix to this proposed rule,
the Emergency Medicine specialty set takes additional criteria into consideration, which includes, but is not limited to: whether a
measure reflects current clinical guidelines, and the coding of the measure includes relevant clinician types. We may reassess the
appropriateness of individual measures, on a case-by-case basis, to ensure appropriate inclusion in the specialty set. Measure
tables in this set include previously finalized measures we are maintaining within the set, measures proposed to be added, and
measures proposed for removal, as applicable. We request comment on the measures available in the proposed Emergency
Medicine specialty set.
B.11. Emergency Medicine
§
!
(Appropriate
Use)
§
!
(Appropriate
Use)
§
!
(Appropriate
Use)
§
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Indicator
PREVIOUSLY FINALIZED MEASURES IN.THE EMERGENCY MEDICINE SPECIALTY SET
CBE#
CMS
Quality
Collection
Measure
I
Me11sure Title
Measure
eCQM
Type
and Description
Steward
eCQM
#
Type
ID
CBE#
'
Appropriate Treatment for
lipper Respiratory Infection
(URI):
eCQM
National
CMS15
Specifications,
Percentage of episodes for patients
00691
Committee for
065
Process
MIPS CQM
N/A
4v13
3 months of age and older with a
Quality Assurance
Specifications
diagnosis of upper respiratory
infection (URI) that did not result in
an antibiotic order.
Appropriate Testing for
Pharyngitis:
The percentage of episodes for
patients 3 years and older with a
eCQM
diagnosis of pharyngitis that
National
Specifications,
NIAi
CMS14
resulted in an antibiotic order on or
Committee for
Process
066
NIA
MIPS CQM
within 3 days after the episode date
6v13
Quality Assurance
and a group A Streptococcus (Strep)
Specifications
test in the 7-day period from three
days prior to the episode date
through three days after the episode
date.
Avoidance of Antibiotic
Treatment for Acute
Bronchitis/Bronchiolitis:
The percentage of episodes for
National
MIPS CQM
0058 I
116
N/A
Process
patients ages 3 months and older
Committee for
N/A
Specifications
Quality Assurance
with a diagnosis of acute
bronchitis/bronchiolitis that did not
result in an antibiotic dispensing
event.
Stroke and Stroke Rehabilitation:
Thrombolytic Therapy:
Percentage of patients aged 18 years
and older with a diagnosis of acute
MIPS CQM
NIAi
ischemic stroke who arrive at the
American Heart
187
N/A
Process
N/A
Specifications
hospital within 3.5 hours of time
Association
last known well and for whom TV
thrombolytic therapy was initiated
within 4.5 hours of time last known
well.
Preventive Care and Screening:
Screening for High Blood
Medicare Part
Pressure and Follow-l! p
B Claims
Documented:
Measure
Percentage of patient visits for
Centers for
NIAi
CMS22
Specifications,
patients aged 18 years and older
317
Process
Medicare &
NIA
vl3
eCQM
seen during the measurement period
Medicaid Services
Specifications,
who were screened for high blood
MIPS CQM
pressure AND a recommended
Specifications
follow-up plan is documented, as
indicated, if blood pressure is
elevated or hypertensive.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
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!
(Appropriate
Use)
!
(Appropriate
Use)
!
(Efficiency)
!
(Efficiency)
!
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Specifications
Process
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MIPS CQM
Specifications
Process
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415
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MIPS CQM
Specifications
Efficiency
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Efficiency
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American
Academy of
Otolaryngology Head and Neck
Surgery
Foundation
American
Academy of
Otolaryngology Head and Neck
Surgery
Foundation
American College
of Emergency
Physicians
American College
of Emergency
Physicians
Centers for
Medicare &
Medicaid Services
EP31JY24.265
*
Adult Sinusitis: Antibiotic
Prescribed for Acute Viral
Sinusitis (Overuse):
Percentage of patients, aged 18
years and older, with a diagnosis of
acute viral sinusitis who were
prescribed an antibiotic within I 0
da s after onset of s m toms.
Adult Sinusitis: Appropriate
Choice of Antibiotic: Amoxicillin
With or Without Clavulanate
Prescribed for Patients with
Acute Bacterial Sinusitis
(Appropriate Use):
Percentage of patients aged 18 years
and older with a diagnosis of acute
bacterial sinusitis that were
prescribed amoxicillin, with or
without clavulanate, as a first line
antibiotic at the time of dia nosis.
Emergency Medicine: Emergency
Department Utilization of CT for
Minor Blunt Head Trauma for
Patients Aged 18 Years and
Older:
Percentage of emergency
department visits for patients aged
18 years and older who presented
with a minor blunt head trauma who
had a head CT for trauma ordered
by an emergency care provider who
have an indication for a head CT.
Emergency Medicine: Emergency
Department Utilization of CT for
Minor Blunt Head Trauma for
Patients Aged 2 through 17
Years:
Percentage of emergency
department visits for patients aged 2
through 17 years who presented
with a minor blunt head trauma who
had a head CT for trauma ordered
by an emergency care provider who
are classified as low risk according
to the Pediatric Emergency Care
Applied Research Network
(PECARN) prediction rules for
traumatic brain in'u
Screening for Social Drivers of
Health:
Percent of patients 18 years and
older screened for food insecurity,
housing instability, transportation
needs, utility difficulties, and
inter ersonal safe
62310
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Connection to Community
Service Provider:
Percent of patients 18 years or older
who screen positive for one or more
of the following health related
social needs (HRSNs): food
insecurity, housing instability,
transportation needs, utility help
needs, or interpersonal safety; and
had contact with a Community
Service Provider (CSP) for at least
1 of their HRSNs within 60 days
after screenin .
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62311
B.11. Emergency Medicine
Elder
Maltreatment
Screen and
Follow-Up Plan:
*
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Medicare&
Medicaid
Services
Rosen, T., Platts-Mills, T. F., & Fulmer, T. (2020). Screening for Elder Mistreatment in Emergency Departments:
Current Progress and Recommendations for Next Steps. Journal of Elder Abuse & Neglect, 32(3), 295-315.
https://doi.org/10.1080/08946566.2020.1768997.
82
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(Patient
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Medicare
PartB
Claims
Measure
Specificati
ons,MIPS
CQM
Specificati
ons
Percentage of
patients aged 60
years and older
with a
documented
elder
maltreatment
screen using an
Elder
Maltreatment
Screening tool on
the date of
encounter AND a
documented
follow-up plan
on the date of the
positive screen.
We are proposing to include
this measure in the Emergency
Medicine specialty set as it
would be clinically relevant to
this clinician type. "Emergency
departments (EDs) are a
potentially important setting
for elder mistreatment
identification because they
provide care for a large number
of older adults who may be
elder mistreatment victims
especially given that the ED is
sometimes the only clinical
setting that the patient may
visit. " 82 The process of
standardized screening using
one or a combination of
validated assessment(s) and/or
instrument(s) should be done to
ensure that signs of abuse or
ne lect are not overlooked.
62312
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B.11. Emergency Medicine
REMOVAL
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PREVIOUSLY FINALIZED MEASURES PROPOSED FOR
FROM TRE EMERGENCY MEDICINE
SPECIALTY SET
N:ote: ln this proposed rule, we are proposing the removal of the following measure(s) below from.this specific specialty measure set based
upon review of updates made to existing quality measure specifications; the proposed addition of new measures for inclusion in MIPS, and the
feedback provided b specialty societies,
'
CBE#
CMS
.Measure
Quality
Collection
Measure Title
Measure
l
eCQM
Type
Rationale for. Removal
Type
And Description
Steward
eCQM
#
ID
·.
·.
CBE#
Preventive Care and
We are proposing to
Screening: Screening for
remove this measure from
Depression and Follow-Up
the Emergency Medicine
Medicare
Plan:
specialty set beginning
Part B
Percentage of patients aged
with the CY 2025
Claims
12 years and older screened
performance periodl2027
MIPS payment year.
Measure
for depression on the date of
Centers for
Specification
the encounter or up to 14
Complete emergency
NIAi
CMS2v
Medicare &
134
s, eCQM
Process
days prior to the date of the
medicine applicable coding
NIA
14
Medicaid
Specification
encounter using an ageis not available within this
Services
s, MIPS
appropriate standardized
quality measure.
CQM
depression screening tool
Therefore, this measure
AND if positive, a follow-up
has minimal eligibility for
Specification
s
plan is documented on the
this clinician type.
date of or up to 2 days after
the date of the qualifying
encounter.
Ultrasound Determination
This measure is being
of Pregnancy Location for
proposed for removal
Pregnant Patients with
beginning with the CY
Abdominal Pain:
2025 performance
Percentage of pregnant
periodl2027 MIPS
female patients aged 14 to
payment year. See Table
American
MIPS CQM
50 who present to the
Group C for rationale.
College of
NIAi
emergency department (ED)
254
NIA
Specification
Process
Emergency
NIA
s
with a chief complaint of
Physicians
abdominal pain or vaginal
bleeding who receive a
trans-abdominal or transvaginal ultrasound to
determine pregnancy
location.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62313
B.12. Endocrinology
In addition to the considerations discussed in the introductory language of Table Group B of this Appendix to this proposed rule,
the Endocrinology specialty set takes additional criteria into consideration, which includes, but is not limited to: whether a
measure reflects current clinical guidelines, and the coding of the measure includes relevant clinician types. We may reassess the
appropriateness of individual measures, on a case-by-case basis, to ensure appropriate inclusion in the specialty set. Measure
tables in this set include previously finalized measures we are maintaining within the set, measures proposed to be added, and
measures proposed for removal, as applicable. We request comment on the measures available in the proposed Endocrinology
specialty set.
B.12. Endocrinology
039
NIA
Medicare Part
B Claims
Measure
Specifications,
MIPSCQM
Specifications
117
CMSl3
lv13
eCQM
Specifications,
MIPSCQM
Specifications
118
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§
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Diabetes: Hemoglobin Ale
(HbAlc) Poor Control
(>9%):
Intermediat Percentage of patients 18-75
e Outcome years of age with diabetes
who had hemoglobin Ale >
9.0% during the measurement
eriod.
Screening for Osteoporosis
for Women Aged 65-85 Years
of Age:
Percentage of women aged
Process
65-85 years of age who ever
had a central dual-energy Xray absorptiometry (DXA) to
check for osteo orosis.
Diabetes: Eye Exam:
Percentage of patients 18-75
years of age with diabetes and
an active diagnosis of
retinopathy in any part of the
measurement period who had
a retinal or dilated eye exam
by an eye care professional
during the measurement
Process
period or diabetics with no
diagnosis ofretinopathy in
any part of the measurement
period who had a retinal or
dilated eye exam by an eye
care professional during the
measurement period or in the
12 months prior to the
measurement eriod.
Coronary Artery Disease
(CAD): AngiotensinConverting Enzyme (ACE)
Inhibitor or Angiotensin
Receptor Blocker (ARB)
Therapy - Diabetes or Left
Ventricular Systolic
Dysfunction (LVEF :;:: 40% ):
Percentage of patients aged I 8
Process
years and older with a
diagnosis of coronary artery
disease seen within a 12month period who also have
diabetes OR a current or prior
Left Ventricular Ejection
Fraction (L VEF):;:: 40% who
were prescribed ACE inhibitor
or ARB thera
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S ecifications
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Medical Association
Centers for Medicare
& Medicaid Services
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& Medicaid Services
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for Quality Assurance
National Committee
for Quality Assurance
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Diabetes Mellitus: Diabetic
Foot and Ankle Care,
Peripheral Neuropathy Neurological Evaluation:
Percentage of patients aged 18
Process
years and older with a
diagnosis of diabetes mellitus
who had a neurological
examination of their lower
extremities within 12 months.
Documentation of Current
Medications in the Medical
Record:
Percentage of visits for
patients aged 18 years and
older for which the eligible
Process
clinician attests to
documenting a list of current
medications using all
immediate resources available
on the date of the encounter.
Preventive Care and
Screening: Screening for
Depression and Follow-Up
Plan:
Percentage of patients aged 12
years and older screened for
depression on the date of the
encounter or up to 14 days
prior to the date of the
Process
encounter using an ageappropriate standardized
depression screening tool
AND if positive, a follow-up
plan is documented on the
date of or up to 2 days after
the date of the qualifying
encounter.
Preventive Care and
Screening: Tobacco Use:
Screening and Cessation
Intervention:
Percentage of patients aged 12
years and older who were
screened for tobacco use one
or more times during the
Process
measurement period AND
who received tobacco
cessation intervention during
the measurement period or in
the 6 months prior to the
measurement period if
identified as a tobacco user.
Controlling High Blood
Pressure:
Percentage of patients 18-85
years of age who had a
diagnosis of essential
hypertension starting before
lntermediat and continuing into, or
eOutcome starting during the first 6
months of the measurement
period, and whose most recent
blood pressure was adequately
controlled (<140/90mmHg)
during the measurement
riod.
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62315
B.12. Endocrinology
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Measure
Specifications,
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Process
eCQM
Specifications,
MIPSCQM
Specifications
Process
eCQM
Specifications
Process
374
*
0053 I
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Centers for Medicare
& Medicaid Services
National Committee
for Quality Assurance
Centers for Medicare
& Medicaid Services
Oregon Urology
Institute
EP31JY24.271
•
Closing the Referral Loop:
Receipt of Specialist Report:
Percentage of patients with
referrals, regardless of age, for
which the referring clinician
receives a report from the
clinician to whom the patient
was referred.
Osteoporosis Management
in Women Who Had a
Fracture:
The percentage of women 50-85 years ofage who suffered a
fracture and who had either a
hone mineral density (BMD)
test or prescription for a drug
to treat osteoporosis in the 6
months after the fracture.
Statin Therapy for the
Prevention and Treatment
of Cardiovascular
Disease:
Percentage of the following
patients - all considered at
high risk of cardiovascular
events - who were prescribed
or were on statin therapy
during the performance
period:
•All patients who were
previously diagnosed with or
currently have a diagnosis of
clinical atherosclerotic
cardiovascular disease
(ASCVD), including an
ASCVD procedure; OR
•Patients aged 20 to 75 years
who have ever had a lowdensity lipoprotein cholesterol
(LDL-C) level 2: 190 mg/dL
or were previously diagnosed
with or currently have an
active diagnosis of familial
hypercholesterolemia; OR
•Patients aged 40 to 75 years
with a diagnosis of diabetes;
OR
•Patients aged 40 to 75 with a
IO-year ASCVD risk score of
2:20 rcent.
Bone Density Evaluation for
Patients with Prostate
Caneer and Receiving
Androgen Deprivation
Therapy:
Patients determined as having
prostate cancer who are
currently starting or
undergoing androgen
deprivation therapy (ADT),
for an anticipated period of 12
months or greater and who
receive an initial bone density
evaluation. The bone density
evaluation must be prior to the
start of ADT or within 3
months of the start of ADT.
62316
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B.12. Endocrinology
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Performan
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Measure
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& Medicaid Services
National Kidney
Foundation
National Committee
for Quality Assurance
OCHIN
Insignia Health, LLC,
a wholly owned
subsidiary of Phreesia
EP31JY24.272
!
(Equity)
Screening for Social Drivers
of Health:
Percent of patients 18 years
and older screened for food
insecurity, housing instability,
transportation needs, utility
difficulties, and interpersonal
safe
Kidney Health Evaluation:
Percentage of patients aged
18-75 years with a diagnosis
of diabetes who received a
kidney health evaluation
defined by an Estimated
Glomerular Filtration Rate
(eGFR) AND Urine AlbuminCreatinine Ratio (uACR)
within the measurement
riod.
Adnlt Immunization Status:
Percentage of patients 19
years of age and older who are
up-to-date on recommended
routine vaccines for influenza;
tetanus and diphtheria (Td) or
tetanus, diphtheria and
acellular pertussis (Tdap );
zoster; and neumococcal.
Connection to Community
Service Provider:
Percent of patients 18 years or
older who screen positive for
one or more of the following
health related social needs
(HRSNs): food insecurity,
housing instability,
transportation needs, utility
help needs, or interpersonal
safety; and had contact with a
Community Service Provider
(CSP) for at least 1 of their
HRSNs within 60 days after
screenin .
Gains in Patient Activation
Measure (PAM®) Scores at
12 Months:
The Patient Activation
Measure® (PAM®) is a 10or 13 - item questionnaire that
assesses an individual's
knowledge, skills and
confidence for managing their
health and health care. The
measure assesses individuals
on a 0-100 scale that converts
to one of four levels of
activation, from low (1) to
high (4). The PAM®
performance measure
(PAM®-PM) is the change in
score on the PAM® from
baseline to follow-up
measurement.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62317
B.12. Endocrinology
83
84
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Centers
for
Medicare
&
Medicaid
Services
See footnote lkeokwu et al., 2023 in Table B.l of this Appendix.
See footnotes Fitzpatrick et al., 2022; Polack et al., 2020; and Grana et al., 2022 in Table A.5 of this Appendix.
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CQM
Specificati
ons
Adult COVID19 Vaccination
Status:
Percentage of
patients aged 18
years and older
seen for a visit
during the
performance
period that are
up-to-date on
their COVID-19
vaccinations as
defined by CDC
recommendation
son current
vaccination.
We are proposing to include this
measure in the Endocrinology
specialty set as it would be
clinically relevant to this clinician
type. Widespread vaccination
against SARS-CoV-2, the virus
that causes COVID-19, is
critically important to stemming
the morbidity and mortality
caused by this disease_._,
Clinicians are uniquely positioned
to encourage uptake ofCOVID19 vaccination, and clinicians are
still a major driving force in
promoting patient vaccination.
The addition of this quality
measure in this specialty set
would help strengthen compliance
with recommended COVID-19
vaccination, leading to
improvement in the quality of
patient care and prevention of
disease for the general population.
This quality measure aligns with
clinical guidelines and the
evidence-based recommendations
of the ACIP, where there is
general agreement about the
safety and efficacy of the
COVID-19 vaccine, preventing
costly and potentially harmful
hospitalizations. 84 Broadening
vaccination status awareness to
this clinician type is valuable as it
can help drive an increase in the
adult vaccination rates. The
COVID-19 vaccination included
within this measure would reduce
the prevalence of severe diseases
that may be associated with
hospitalization and decrease
overall health care costs. The
measure being added to this
specialty set would be contingent
on the inclusion of applicable
coding by the time of the CY
2025 PFS final rule. In the event
appropriate coding is not included
in the final specification, this
measure would not be finalized
for inclusion within this specialty
measure set. See Table A.5 of this
Appendix for rationale, including
clinical evidence supporting the
inclusion of this measure in
MIPS.
62318
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8.13. Family Medicine
In addition to the considerations discussed in the introductory language of Table Group B of this Appendix to this proposed rule,
the Family Medicine specialty set takes additional criteria into consideration, which includes, but is not limited to: whether a
measure reflects current clinical guidelines, and the coding of the measure includes relevant clinician types. We may reassess the
appropriateness ofindividual measures, on a case-by-case basis, to ensure appropriate inclusion in the specialty set. Measure
tables in this set include previously finalized measures we are maintaining within the set, measures proposed to be added, and
measures proposed for removal, as applicable. We request comment on the measures available in the proposed Family Medicine
specialty set.
8.13. Family Medicine
§
!
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008Ie
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Specifications
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§
00671
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006
NIA
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Specifications
Process
§
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007
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Outcome
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Diabetes: Hemoglobin Ale
(HbAtc) Poor Control
(>9%):
Percentage of patients 18-75
years of age with diabetes who
had hemoglobin Ale> 9.0%
during the measurement
eriod.
Heart Failure (HF):
Angiotensin-Converting
Enzyme (ACE) Inhibitor or
Angiotensin Receptor
Blocker (ARB) or
Angiotensin ReceptorNeprilysin Inhibitor (ARNI)
Therapy for Left Ventricular
Systolic Dysfunction
(LVSD):
Percentage of patients aged 18
years and older with a
diagnosis of heart failure (HF)
with a current or prior left
ventricular ejection fraction
(LVEF) :::: 40% who were
prescribed ACE inhibitor or
ARB or ARNI therapy either
within a 12-month period
when seen in the outpatient
setting OR at each hospital
dischar e.
Coronary Artery Disease
(CAD): Antiplatelet
Therapy:
Percentage of patients aged 18
years and older with a
diagnosis of coronary artery
disease (CAD) seen within a
12-month period who were
prescribed aspirin or
clo ido el.
Coronary Artery Disease
(CAD): Beta-Blocker
Therapy - Prior Myocardial
Infarction (Ml) or Left
Ventricular Systolic
Dysfunction (LVEF :5 40%):
Percentage of patients aged 18
years and older with a
diagnosis of coronary artery
disease seen within a 12month period who also have a
prior Ml or a current or prior
LVEF S 40% who were
prescribed beta-blocker
thera
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American Heart
Association
National
Committee for
Quality Assurance
National
Committee for
QuaIity Assurance
National
Committee for
Qua! ity Assurance
EP31JY24.275
§
0083 /
0083e
Heart Failure (HF): BetaBlocker Therapy for Left
Ventricular Systolic
Dysfunction (LVSD):
Percentage of patients aged 18
years and older with a
diagnosis of heart failure (HF)
with a current or prior left
ventricular ejection fraction
(L VEF)::: 40% who were
prescribed beta-blocker
therapy either within a 12month period when seen in the
outpatient setting OR at each
hos ital dischar e.
Antidepressant Medication
Management:
Percentage of patients 18 years
ofage and older who were
treated with antidepressant
medication, had a diagnosis of
major depression, and who
remained on an antidepressant
medication treatment. Two
rates are reported.
A. Percentage of patients who
remained on an antidepressant
medication for at least 84 days
(12 weeks).
b. Percentage of patients who
remained on an antidepressant
medication for at least 180
da s 6 months .
Communication with the
Physician or Other Clinician
Managing On-Going Care
Post-Fracture for Men and
Women Aged 50 Years and
Older:
Percentage of patients aged 50
years and older treated for a
fracture with documentation of
communication, between the
physician treating the fracture
and the physician or other
clinician managing the
patient's on-going care, that a
fracture occurred and that the
patient was or should be
considered for osteoporosis
treatment or testing. This
measure is submitted by the
physician who treats the
fracture and who therefore is
held accountable for the
communication.
Screeuing for Osteoporosis for
Women Aged 65-85 Years of
Age:
Percentage of women aged 6585 years of age who ever had a
central dual-energy X-ray
absorptiometry (DXA) to
check for osteo orosis.
62320
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National
Committee for
Quality Assurance
National
Committee for
Quality Assurance
National
Committee for
Quality Assurance
National
Committee for
Quality Assurance
National
Committee for
Quality Assurance
National
Committee for
Quality Assurance
EP31JY24.276
047
Medicare Part B
Claims Measure
Specifications,
MIPSCQM
Specifications
*
Advance Care Plan:
Percentage of patients aged 65
years and older who have an
advance care plan or surrogate
decision maker documented in
the medical record or
documentation in the medical
record that an advance care plan
was discussed but the patient did
not wish or was not able to nam
a surrogate decision maker or
rovide an advance care Ian.
Urinary Incontinence:
Assessment of Presence or
Absence of Urinary
Incontinence in Women
Aged 65 Years and Older:
Percentage offemale patients
aged 65 years and older who
were assessed for the presence
or absence of urinary
incontinence within 12 months.
Urinary Incontinence: Plan of
Care for Urinary Incontinence
in Women Aged 65 Years and
Older:
Percentage offemale patients
aged 65 years and older with a
diagnosis of urinary
incontinence with a
documented plan of care for
urinary incontinence at least
once within 12 months.
Appropriate Treatment for
Upper Respiratory Infection
(URI):
Percentage of episodes for
patients 3 months of age and
older with a diagnosis of upper
respiratory infection (URI) that
did not result in an antibiotic
order.
Appropriate Testing for
Pharyngitis:
The percentage of episodes for
patients 3 years and older with a
diagnosis of pharyngitis that
resulted in an antibiotic order on
or within 3 days after the
episode date and a group A
Streptococcus (Strep) test in the
7-day period from three days
prior to the episode date through
three davs after the e isode date.
Avoidance of Antibiotic
Treatment for Acute
Brouchitis/Brouchiolitis:
The percentage of episodes for
patients ages 3 months and
older with a diagnosis of acute
bronchitis/bronchiolitis that
did not result in an antibiotic
dis ensin event.
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Specifications,
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Specifications
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Specifications,
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National
Committee for
Quality Assurance
American
Podiatric Medical
Association
Centers for
Medicare &
Medicaid Services
Centers for
Medicare &
Medicaid Services
National
Committee for
Quality Assurance
EP31JY24.277
*
Diabetes: Eye Exam:
Percentage of patients 18-75
years ofage with diabetes and
an active diagnosis of
retinopathy in any part of the
measurement period who had a
retinal or dilated eye exam by
an eye care professional during
the measurement period or
diabetics with no diagnosis of
retinopathy in any part of the
measurement period who had a
retinal or dilated eye exam by
an eye care professional during
the measurement period or in
the 12 months prior to the
measurement eriod.
Diabetes Mellitus: Diabetic
Foot and Ankle Care,
Peripheral Neuropathy Neurological Evaluation:
Percentage of patients aged 18
years and older with a
diagnosis of diabetes mellitus
who had a neurological
examination of their lower
extremities within 12 months.
Documentation of Current
Medications in the Medical
Record:
Percentage of visits for patients
aged 18 years and older for
which the eligible clinician
attests to documenting a list of
current medications using all
immediate resources available
on the date of the encounter.
Preventive Care and
Screening: Screening for
Depression and Follow-Up
Plan:
Percentage of patients aged 12
years and older screened for
depression on the date of the
encounter or up to 14 days
prior to the date of the
encounter using an ageappropriate standardized
depression screening tool
AND if positive, a follow-up
plan is documented on the date
of or up to 2 days after the date
ofthe uali in encounter.
Falls: Plan of Care:
Percentage of patients aged 65
years and older with a history
of falls who had a plan of care
for falls documented within 12
months.
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American College
of Rheumatology
Centers for
Medicare &
Medicaid Services
Centers for
Medicare &
Medicaid Services
National
Committee for
Quality Assurance
National
Committee for
Quality Assurance
EP31JY24.278
*
Tuberculosis Screening Prior
to First Course of Biologic
and/or Immune Response
Modifier Therapy:
If a patient has been newly
prescribed a biologic and/or
immune response modifier that
includes a warning for
potential reactivation of a
latent infection, then the
medical record should indicate
TB testing in the preceding 12month eriod.
Elder Maltreatment Screen
and Follow-Up Plan:
Percentage of patients aged 60
years and older with a
documented elder
maltreatment screen using an
Elder Maltreatment Screening
tool on the date of encounter
AND a documented follow-up
plan on the date of the positive
screen.
Functional Outcome
Assessment:
Percentage of visits for
patients aged 18 years and
older with documentation of a
current functional outcome
assessment using a
standardized functional
outcome assessment tool on
the date of the encounter AND
documentation of a care plan
based on identified functional
outcome deficiencies within 2
days of the date of the
identified deficiencies.
Controlling High Blood
Pressure:
Percentage of patients 18-85
years of age who had a
diagnosis of essential
hypertension starting before
and continuing into, or starting
during the first 6 months of the
measurement period, and
whose most recent blood
pressure was adequately
controlled (<140/90mmHg)
during the measurement
eriod.
Use of High-Risk
Medications in Older Adults:
Percentage of patients 65 years
of age and older who were
ordered at least two high-risk
medications from the same
dru class.
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Association
National
Committee for
Quality Assurance
National
Committee for
Quality Assurance
EP31JY24.279
!
(Care
Coordination)
Cardiac Rehabilitation
Patient Referral from an
Outpatient Setting:
Percentage of patients
evaluated in an outpatient
setting who within the
previous 12 months have
experienced an acute
myocardial infarction (MI),
coronary artery bypass graft
(CABG) surgery, a
percutaneous coronary
intervention (PCI}, cardiac
valve surgery, or cardiac
transplantation, or who have
chronic stable angina (CSA)
and have not already
participated in an early
outpatient cardiac
rehabilitation/secondary
prevention (CR) program for
the qualifying event/diagnosis
who were referred to a CR
ro ram.
Initiation and Engagement of
Substance Use Disorder
Treatment:
Percentage of patients 13 years
of age and older with a new
substance use disorder (SUD)
episode who received the
following (Two rates are
reported):
a. Percentage of patients who
initiated treatment, including
either an intervention or
medication for the treatment of
SUD, within 14 days of the
new SUD episode.
b. Percentage of patients who
engaged in ongoing treatment,
including two additional
interventions or medication
treatment events for SUD, or
one long-acting medication
event for the treatment of
SUD, within 34 days of the
initiation.
Cervical Cancer Screening:
Percentage ofwomen 21-64
years of age who were
screened for cervical cancer
using either of the following
criteria:
• Women age 21-64 who had
cervical cytology performed
within the last 3 years
• Women age 30-64 who had
cervical human papillomavirus
(HPV) testing performed
within the last 5 ears
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Committee for
Quality Assurance
Centers for
Medicare &
Medicaid Services
American Heart
Association
EP31JY24.280
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Safety)
Falls: Screening for Future
Fall Risk:
Percentage of patients 65 years
of age and older who were
screened for future fall risk
during the measurement
eriod.
CAHPS for MIPS
Clinician/Group Survey:
The Consumer Assessment of
Healthcare Providers and
Systems (CAHPS) for MIPS
Clinician/Group Survey is
comprised of 10 Summary
Survey Measures (SSMs) and
measures patient experience of
care within a group practice.
The CBE endorsement status
and endorsement id (if
applicable) for each SSM
utilized in this measure are as
follows:
• Getting Timely Care,
Appointments, and
Information; (Not endorsed by
CBE)
• How well Providers
Communicate; (Not endorsed
byCBE)
• Patient's Rating of Provider;
(CBE endorsed# 0005)
• Access to Specialists; (Not
endorsed by CBE)
• Health Promotion and
Education; (Not endorsed by
CBE)
• Shared Decision-Making;
(Not endorsed by CBE)
• Health Status and Functional
Status; (Not endorsed by CBE)
• Courteous and Helpful Office
Staff; (CBE endorsed# 0005)
• Care Coordination; (Not
endorsed by CBE)
• Stewardship of Patient
Resources. (Not endorsed by
CBE
Atrial Fibrillation and Atrial
Flutter: Chronic
Anticoagulation Therapy:
Percentage of patients aged 18
years and older with atrial
fibrillation (AF) or atrial
flutter who were prescribed an
FDA-approved oral
anticoagulant drug for the
prevention of
thromboembolism during the
measurement eriod.
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American
Academy of
Otolaryngology Head and Neck
Surgery
Foundation
American
Academy of
Otolaryngology Head and Neck
Surgery
Foundation
Health Resources
and Services
Administration
Minnesota
Community
Measurement
Centers for
Medicare &
Medicaid Services
Centers for
Medicare &
Medicaid Services
EP31JY24.281
*
Adult Sinusitis: Antibiotic
Prescribed for Acute Viral
Sinusitis (Overuse):
Percentage of patients, aged 18
years and older, with a
diagnosis of acute viral
sinusitis who were prescribed
an antibiotic within 10 days
after onset of s m toms.
Adult Sinusitis: Appropriate
Choice of Antibiotic:
Amoxicillin With or Without
Clavulanate Prescribed for
Patients with Acute Bacterial
Sinusitis (Appropriate Use):
Percentage of patients aged 18
years and older with a
diagnosis of acute bacterial
sinusitis that were prescribed
amoxicillin, with or without
clavulanate, as a first line
antibiotic at the time of
dia nosis.
HIV Viral Suppression:
Percentage of patients,
regardless of age, diagnosed
with HIV prior to or during the
first 90 days of the
performance period, with an
eligible encounter in the first
240 days of the performance
period, whose last HIV viral
load test result was less than
200 copieslmL during the
erformance eriod.
Depression Remission at
Twelve Months:
The percentage of adolescent
patients 12 to 17 years of age
and adult patients 18 years of
age or older with major
depression or dysthymia who
reached remission 12 months
(+I- 60 days) after an index
event date.
Closing the Referral Loop:
Receipt of Specialist Report:
Percentage of patients with
referrals, regardless of age, for
which the referring clinician
receives a report from the
clinician to whom the patient
was referred.
Functional Status
Assessments for Heart
Failure:
Percentage of patients 18 years
of age and older with heart
failure who completed initial
and follow-up patient-reported
functional status assessments.
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Medicare &
Medicaid Services
American
Gastroenterologic
al Association
National
Committee for
Quality Assurance
Minnesota
Community
Measurement
American
Gastroenterologic
al Association
EP31JY24.282
*
Adherence to Antipsychotic
Medications for Individuals
with Schizophrenia:
Percentage of individuals at
least 18 years of age as of the
beginning of the performance
period with schizophrenia or
schizoaffective disorder who
had at least two prescriptions
filled for any antipsychotic
medication and who had a
Proportion of Days Covered
(PDC) of at least 0.8 for
antipsychotic medications
durin the erformance eriod.
Annual Hepatitis C Virus
(HCV) Screening for
Patients who are Active
Injection Drug Users:
Percentage of patients,
regardless of age, who are
active injection drug users who
received screening for HCV
infection within the 12-month
re ortin eriod.
Immunizations for
Adolescents:
The percentage of adolescents
13 years of age who had one
dose ofmeningococcal vaccine
(serogroups A, C, W, Y), one
tetanus, diphtheria toxoids and
acellular pertussis (Tdap)
vaccine, and have completed
the Human Papillomavirus
(HPV) vaccine series by their
13 th birthda .
Optimal Asthma Control:
Composite measure of the
percentage of pediatric and
adult patients whose asthma is
well-controlled as
demonstrated by one of three
age appropriate patient
reported outcome tools and not
at risk for exacerbation.
One-Time Screening for
Hepatitis C Virus (HCV) and
Treatment Initiation:
Percentage of patients age>=
18 years have never been
tested for Hepatitis C Virus
(HCV) infection who receive
an HCV infection test AND
who have treatment initiated
within three months or who are
referred to a clinician who
treats HCV infection within
one month if tested positive for
HCV.
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Hepatitis C: Screening for
Hepatocellular Carcinoma
(HCC) in Patients with
Cirrhosis:
Percentage of patients aged 18
years and older with a
diagnosis of chronic Hepatitis
C cirrhosis who underwent
imaging with either
ultrasound, contrast enhanced
CT or MRI for hepatocellular
carcinoma (HCC) at least once
within the 12-month
submission eriod.
Osteoporosis Management in
Women Who Had a
Fracture:
The percentage of women 5085 years of age who suffered a
fracture and who had either a
bone mineral density (BMD)
test or prescription for a drug
to treat osteoporosis in the 6
months after the fracture.
Preventive Care and
Screening: Unhealthy
Alcohol Use: Screening &
Brief Counseling:
Percentage of patients aged 18
years and older who were
screened for unhealthy alcohol
use using a systematic
screening method at least once
within the last 12 months AND
who received brief counseling
if identified as an unhealthy
alcohol user.
E:\FR\FM\31JYP2.SGM
31JYP2
American
Gastroenterologic
al Association
National
Committee for
Quality Assurance
National
Committee for
Quality Assurance
EP31JY24.283
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Centers for
Medicare &
Medicaid Services
Wisconsin
Collaborative for
Healthcare Quality
EP31JY24.284
§
Statin Therapy for the
Prevention and Treatment of
Cardiovascular Disease:
Percentage of the following
patients - all considered at
high risk of cardiovascular
events - who were prescribed
or were on statin therapy
during the performance period:
•All patients who were
previously diagnosed with or
currently have a diagnosis of
clinical atherosclerotic
cardiovascular disease
(ASCVD), including an
ASCVD procedure; OR
•Patients aged 20 to 75 years
who have ever had a lowdensity lipoprotein cholesterol
(LDL-C) level 2> 190 mgldL or
were previously diagnosed
with or currently have an
active diagnosis of familial
hypercholesterolemia; OR
•Patients aged 40 to 75 years
with a diagnosis of diabetes;
OR
•Patients aged 40 to 75 with a
I 0-year ASCVD risk score of
2> 20 ercent.
Ischemic Vascular Disease
(IVD) All or None Outcome
Measure (Optimal Control):
The TVD All-or-None Measure
is one outcome measure
(optimal control). The measure
contains four goals. All four
goals within a measure must
be reached in order to meet
that measure. The numerator
for the all-or-none measure
should be collected from the
organization's total TVD
denominator. All-or-None
Outcome Measure (Optimal
Control) - Using the TVD
denominator optimal results
include:
• Most recent blood pressure
(BP) measurement is less than
or equal to 140/90 mm Hg AND
• Most recent tobacco status is
Tobacco Free - AND
• Daily Aspirin or Other
Antiplatelet Unless
Contraindicated - AND
• Statin Use Unless
Contraindicated.
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Non-Recommended Cervical
Cancer Screening in
Adolescent Females:
The percentage of adolescent
females 16--20 years of age
who were screened
unnecessarily for cervical
cancer.
Otitis Media with Effusion:
Systemic Antimicrobials Avoidance of Inappropriate
Use:
Percentage of patients aged 2
months through 12 years with
a diagnosis ofOME who were
not prescribed systemic
antimicrobials.
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Use)
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Specifications
eCQM
Specifications
Process
Process
Continuity of
Pharmacotherapy for Opioid
Use Disorder (OUD):
Percentage of adults aged 18
years and older with
pharmacotherapy for opioid
use disorder (OUD) who have
at least 180 days of continuous
treatment.
Process
HIV Screening:
Percentage of patients aged
15-65 at the start of the
measurement period who were
between 15-65 years old when
tested for Human
Immunodeficiency Virus
PatientReported
OutcomeBased
Performance
Measure
Urinary Symptom Score
Change 6-12 Months After
Diagnosis of Benign Prostatic
Hyperplasia:
Percentage of patients with an
office visit within the
measurement period and with
a new diagnosis of clinically
significant Benign Prostatic
Hyperplasia who have
Intemational Prostate
Symptoms Score (IPSS) or
American Urological
Association (AUA) Symptom
Index (SI) documented at time
of diagnosis and again 6-12
months later with an
Centers for
Medicare &
Medicaid Services
American
Academy of
Otolaryngology Head and Neck
Surgery
Foundation
University of
Southern
California
Centers for
Disease Control
and Prevention
HIV.
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Large Urology
Group Practice
Association and
Oregon Urology
Institute
EP31JY24.285
!
(Outcome)
CMS7
7lv6
62330
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!
(Equity)
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487
NIA
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Specifications
Process
488
CMS9
51v3
eCQM
Specifications,
MIPSCQM
Specifications
Process
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NIA
MIPSCQM
Specifications
Process
MIPSCQM
Specifications
PatientReported
OutcomeBased
Performance
Measure
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The American
Board of Family
Medicine
Centers for
Medicare&
Medicaid Services
National Kidney
Foundation
National
Committee for
Quality Assurance
American
Academy of
Hospice and
Palliative
Medicine
(AAHPM)
EP31JY24.286
!
(Outcome)
PatientReported
OutcomeBased
Performance
Measure
Person-Centered Primary
Care Measure Patient
Reported Outcome
Performance Measure
(PCPCM PRO-PM):
The Person-Centered Primary
Care Measure Patient Reported
Outcome Performance
Measure (PCPCM PRO-PM)
uses the PCPCM Patient
Reported Outcome Measure
(PROM) a comprehensive and
parsimonious set of 11 patientreported items - to assess the
broad scope of primary care.
Unlike other primary care
measures, the PCPCM PROPM measures the high value
aspects of primary care based
on a patient's relationship with
the clinician or ractice.
Screening for Social Drivers
of Health:
Percent of patients 18 years
and older screened for food
insecurity, housing instability,
transportation needs, utility
difficulties, and interpersonal
safe
Kidney Health Evaluation:
Percentage of patients aged
18-75 years with a diagnosis of
diabetes who received a
kidney health evaluation
defined by an Estimated
Glomerular Filtration Rate
(eGFR) AND Urine AlbuminCreatinine Ratio (uACR)
within the measurement
eriod.
Adult Immunization Status:
Percentage of patients 19 years
of age and older who are upto-date on recommended
routine vaccines for influenza;
tetanus and diphtheria (Td) or
tetanus, diphtheria and
acellular pertussis (Tdap);
zoster- and neumococcal.
Ambulatory Palliative Care
Patients' Experience of
Feeling Heard and
Understood: The percentage
of top-box responses among
patients aged 18 years and
older who had an ambulatory
palliative care visit and report
feeling heard and understood
by their palliative care
clinician and team within 2
months (60 days) of the
ambulatory palliative care
visit.
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!
(Equity)
!
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Centers for
Medicare and
Medicaid Services
OCHTN
American
Psychiatric
Association
EP31JY24.287
*
Preventive Care and
Wellness (composite):
Percentage of patients who
received age- and sexappropriate preventive
screenings and wellness
services. This measure is a
composite of seven component
measures that are based on
recommendations for
preventive care by the U.S.
Preventive Services Task
Force (USPSTF), ACIP),
American Association of
Clinical Endocrinology
(AACE), and American
College of Endocrinology
ACE.
Connection to Community
Service Provider:
Percent of patients 18 years or
older who screen positive for
one or more of the following
health related social needs
(HRSNs): food insecurity,
housing instability,
transportation needs, utility
help needs, or interpersonal
safety; and had contact with a
Community Service Provider
(CSP) for at least 1 of their
HRSNs within 60 days after
screenin .
Improvement or
Maintenance of Functioning
for Individuals with a
Mental and/or Substance Use
Disorder:
The percentage of patients
aged 18 and older with a
mental and/or substance use
disorder who demonstrated
improvement or maintenance
of functioning based on results
from the 12-item World Health
Organization Disability
Assessment Schedule
(WHODAS 2.0) or Sheehan
Disability Scale (SDS) 30 to
180 days after an index
assessment.
62332
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!
(Safety)
*
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Measure
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Insignia Health,
LLC,awholly
owned subsidiary
ofPhreesia
American
Psychiatric
Association
American
Psychiatric
Association
EP31JY24.288
*
PatientReported
OutcomeBased
Performance
Measure
Gains in Patient Activation
Measure (PAM®) Scores at
12 Months:
The Patient Activation
Measure® (PAM®) is a 10or 13 - item questionnaire that
assesses an individual's
knowledge, skills and
confidence for managing their
health and health care. The
measure assesses individuals
on a 0-100 scale that converts
to one of four levels of
activation, from low (1) to
high (4). The PAM®
performance measure (PAM®PM) is the change in score on
the PAM® from baseline to
follow-u measurement.
Initiation, Review, And/Or
Update To Suicide Safety
Plan For Individuals With
Suicidal Thoughts, Behavior,
Or Suicide Risk:
Percentage of adult aged 18
years and older with suicidal
ideation or behavior symptoms
(based on results of a
standardized assessment tool
or screening tool) or increased
suicide risk (based on the
clinician's evaluation or
clinician-rating tool) for whom
a suicide safety plan is
initiated, reviewed, and/or
updated in collaboration
between the patient and their
clinician.
Reduction in Suicidal
Ideation or Behavior
Symptoms: The percentage of
patients aged 18 and older with
a mental and/or substance use
disorder AND suicidal
thoughts, behaviors or risk
symptoms who demonstrated a
reduction in suicidal ideation
and/or behavior symptoms
based on results from the
Columbia-Suicide Severity
Rating Scale (C-SSRS)
'Screen Version' or 'Since
Last Visit' within 120 days
after an index assessment.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62333
B.13. Family Medicine
85
86
TBD
NIA
MIPS
CQM
Specificati
ons
Process
Centers for
Medicare&
Medicaid
Services
See footnote lkeokwu et al., 2023 in Table B.l of this Appendix.
See footnotes Fitzpatrick et al., 2022; Polack et al., 2020; and Grana et al., 2022 in Table A.5 of this Appendix.
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Adult COVID19 Vaccination
Status:
Percentage of
patients aged 18
years and older
seen for a visit
during the
performance
period that are
up-to-date on
their COVTD-19
vaccinations as
defined by CDC
recommendation
son current
vaccination.
We are proposing to include
this measure in the Family
Medicine specialty set as it
would be clinically relevant to
this clinician type. Widespread
vaccination against SARSCo V-2, the virus that causes
COVID-19, is critically
important to stemming the
morbidity and mortality caused
by this disease. 85 Clinicians are
uniquely positioned to
encourage uptake ofCOVID19 vaccination, and clinicians
are still a major driving force
in promoting patient
vaccination. The addition of
this quality measure in this
specialty set would help
strengthen compliance with
recommended COVTD- I 9
vaccination, leading to
improvement in the quality of
patient care and prevention of
disease for the general
population. This quality
measure aligns with clinical
guidelines and the evidencebased recommendations of the
ACIP, where there is general
agreement about the safety and
efficacy of the COVID-19
vaccine, preventing costly and
potentially harmful
hospitalizations. 86 Broadening
vaccination status awareness to
this clinician type is valuable
as it can help drive an increase
in the adult vaccination rates.
The COVID-19 vaccination
included within this measure
would reduce the prevalence of
severe diseases that may be
associated with hospitalization
and decrease overall health
care costs. The measure being
added to this specialty set
would be contingent on the
inclusion ofapplicable coding
by the time of the CY 2025
PFS final rule. In the event
appropriate coding is not
included in the final
specification, this measure
would not be fmalized for
inclusion within this specialty
measure set. See Table A.5 of
this Appendix for rationale,
including clinical evidence
supporting the inclusion of this
measure in MIPS.
62334
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This measure is being
proposed for removal
beginning with the CY
2025 performance
periodl2027 MIPS
payment year. See Table
Group C for rationale.
EP31JY24.290
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3475e
Appropriate Use of DXA
Scans in Women Under 65
Years Who Do Not Meet
the Risk Factor Profile for
Osteoporotic Fracture:
Percentage of female
patients 50 to 64 years of
age without select risk
factors for osteoporotic
fracture who received an
order for a dual-energy xray absorptiometry (DXA)
scan during the
measurement eriod.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62335
8.14. Gastroenterology
In addition to the considerations discussed in the introductory language of Table Group B of this Appendix to this proposed rule,
the Gastroenterology specialty set takes additional criteria into consideration, which includes, but is not limited to: whether a
measure reflects current clinical guidelines, and the coding of the measure includes relevant clinician types. We may reassess the
appropriateness of individual measures, on a case-by-case basis, to ensure appropriate inclusion in the specialty set. Measure
tables in this set include previously finalized measures we are maintaining within the set, measures proposed to be added, and
measures proposed for removal, as applicable. We request comment on the measures available in the proposed Gastroenterology
specialty set.
B.14. Gastroenterology
!
(Care
Coordinatio
n)
047
NIA
NIA/NIA
130
CMS68v
14
eCQM
Specifications,
MIPSCQM
Specifications
Process
N/A/N/A
185
NIA
MIPSCQM
Specifications
Process
CMS138
v13
Medicare Part
BClaims
Measure
Specifications,
eCQM
Specifications,
MIPSCQM
Specifications
Process
*
§
!
(Patient
Safety)
Process
*
§
!
(Care
Coordinatio
n)
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National Committee
for Quality Assurance
Centers for Medicare
& Medicaid Services
American
Gastroenterological
Association
National Committee
for Quality Assurance
EP31JY24.291
0326 I
NIA
Medicare Part
BClaims
Measure
Specifications,
MIPSCQM
Specifications
*
Advance Care Plan:
Percentage of patients aged
65 years and older who have
an advance care plan or
surrogate decision maker
documented in the medical
record or documentation in
the medical record that an
advance care plan was
discussed but the patient did
not wish or was not able to
name a surrogate decision
maker or provide an advance
care Ian.
Documentation of Current
Medications in the Medical
Record:
Percentage of visits for
patients aged 18 years and
older for which the eligible
clinician attests to
documenting a list of current
medications using all
immediate resources
available on the date of the
encounter.
Colonoscopy Interval for
Patients with a History of
Adenomatous Polyps Avoidance of Inappropriate
Use:
Percentage of patients aged
18 years and older receiving
a surveillance colonoscopy,
with a history of prior
adenomatous polyp(s) in
previous colonoscopy
findings, which had an
interval of 3 or more years
since their last colonosco
Preventive Care and
Screening: Tobacco Use:
Screening and Cessation
Intervention:
Percentage of patients aged
12 years and older who were
screened for tobacco use one
or more times during the
measurement period AND
who received tobacco
cessation intervention during
the measurement period or in
the 6 months prior to the
measurement period if
identified as a tobacco user.
62336
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
B.14. Gastroenterology
.
NA/NIA
NIA/NIA
NIA
MIPSCQM
Specifications
Process
CMS22v
13
Medicare Part
BClaims
Measure
Specifications,
eCQM
Specifications,
MIPSCQM
Specifications
Process
320
NIA
Medicare Part
BClaims
Measure
Specifications,
MIPSCQM
Specifications
Process
eCQM
Specifications,
MIPSCQM
Specifications
Process
MIPSCQM
Specifications
Process
275
317
*
§
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(Care
Coordinatio
n)
0658 f
NIA
*
!
(Care
Coordinatio
n)
N/A/N/A
374
CMS50v
13
§
NIA/NIA
401
NIA
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American
Gastroenterological
Association
Centers for Medicare
& Medicaid Services
American
Gastroenterological
Association
Centers for Medicare
& Medicaid Services
American
Gastroenterological
Association
EP31JY24.292
§
Inflammatory Bowel
Disease (IBD): Assessment
of Hepatitis B Virus (HBV)
Status Before Initiating
Anti-TNF (Tumor Necrosis
Factor) Therapy:
Percentage of patients with a
diagnosis of inflammatory
bowel disease (IBD) who had
Hepatitis B Virus (HBV)
status assessed and results
interpreted prior to initiating
anti-TNF (tumor necrosis
factor thera
Preventive Care and
Screening: Screening for
High Blood Pressure and
Follow-Up Documented:
Percentage of patient visits
for patients aged 18 years
and older seen during the
measurement period who
were screened for high blood
pressure AND a
recommended follow-up plan
is documented, as indicated,
if blood pressure is elevated
orh ertensive.
Appropriate Follow-Up
Interval for Normal
Colonoscopy in Average
Risk Patients:
Percentage of patients aged
45 to 75 years of age
receiving a screening
colonoscopy without biopsy
or polypectomy who had a
recommended follow-up
interval of at least IO years
for repeat colonoscopy
documented in their
colonosco re ort.
Closing the Referral 1,oop:
Receipt of Specialist
Report:
Percentage of patients with
referrals, regardless of age,
for which the referring
clinician receives a report
from the clinician to whom
the tient was referred.
Hepatitis C: Screening for
Hepatocellular Carcinoma
(HCC) in Patients with
Cirrhosis:
Percentage of patients aged
18 years and older with a
diagnosis of chronic
Hepatitis C cirrhosis who
underwent imaging with
either ultrasound, contrast
enhanced CT or MRI for
hepatocellular carcinoma
(HCC) at least once within
the 12-month submission
eriod.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62337
B.14. Gastroenterology
!
(Equity
21521
NIA
431
NIA
MTPSCQM
Specifications
Process
NIAINIA
487
NIA
MIPSCQM
Specifications
Process
NIAINIA
498
NIA
*
!
(Equity)
*
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!
(Outcome)
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Performan
ce
Measure
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National Committee
for Quality Assurance
Centers for Medicare
& Medicaid Services
OCHIN
Insignia Health, LLC,
a wholly owned
subsidiary of Phreesia
EP31JY24.293
§
Preventive Care and
Screening: Unhealthy
Alcohol Use: Screening &
Brief Counseling:
Percentage of patients aged
18 years and older who were
screened for unhealthy
alcohol use using a
systematic screening method
at least once within the last
12 months AND who
received brief counseling if
identified as an unhealthy
alcohol user.
Screening for Social
Drivers of Health:
Percent of patients 18 years
and older screened for food
insecurity, housing
instability, transportation
needs, utility difficulties, and
inte ersonal safe
Connection to Community
Service Provider:
Percent of patients 18 years
or older who screen positive
for one or more of the
following health related
social needs (HRSNs): food
insecurity, housing
instability, transportation
needs, utility help needs, or
interpersonal safety; and had
contact with a Community
Service Provider (CSP) for at
least 1 of their HRSNs within
60 da s after screenin .
Gains in Patient Activation
Measure (PAM®) Scores at
12 Months:
The Patient Activation
Measure® (PAM®) is a 10 or 13 - item questionnaire
that assesses an individual's
knowledge, skills and
confidence for managing
their health and health care.
The measure assesses
individuals on a 0-100 scale
that converts to one of four
levels of activation, from low
(l)tohigh(4). The PAM®
performance measure
(PAM®-PM) is the change in
score on the PAM® from
baseline to follow-up
measurement.
62338
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8.14. Gastroenterology
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Gastroenterological
Association
E:\FR\FM\31JYP2.SGM
31JYP2
This measure is being
proposed for removal
beginning with the
CY 2025
performance
periodl2027 MIPS
payment year. See
Table Group C for
rationale.
EP31JY24.294
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Age Appropriate
Screening Colonoscopy:
The percentage of
screening colonoscopies
performed in patients
greater than or equal to 86
years of age from January
I to December 31.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62339
B.15. General Surgery
In addition to the considerations discussed in the introductory language of Table Group B of this Appendix to this proposed rule,
the General Surgery specialty set takes additional criteria into consideration, which includes, but is not limited to: whether a
measure reflects current clinical guidelines, and the coding of the measure includes relevant clinician types. We may reassess the
appropriateness of individual measures, on a case-by-case basis, to ensure appropriate inclusion in the specialty set. Measure
tables in this set include previously finalized measures we are maintaining within the set, measures proposed to be added, and
measures proposed for removal, as applicable. We request comment on the measures available in the proposed General Surgery
specialty set that have proposed substantive changes in Table Group D of this Appendix as indicated by an* in the Indicator
column.
B.15. General Surgery
*
!
(Care
Coordination)
*
§
!
(Patient
Safety)
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EP31JY24.295
Indicator
PREVIOUSLY FINALIZED MEASURES IN THE GENERAL SURGERY SPECIALTY SET
CBE
#I
CMS
eCQ
Quality
Collection
Measure
Measure Title
eCQM
Measure Steward
Type
M
#
and Description
Type
ID
CBE
#
Advance Care Plan:
Percentage of patients aged 65
years and older who have an
advance care plan or surrogate
Medicare Part
decision maker documented in
B Claims
the medical record or
0326 I
Measure
National Committee
Process
documentation in the medical
047
NIA
Specifications,
for Quality Assurance
NIA
record that an advance care plan
MIPS CQM
was discussed but the patient
Specifications
did not wish or was not able to
name a surrogate decision
maker or provide an advance
care plan.
Documentation of Current
Medications in the Medical
Record:
eCQM
Percentage of visits for patients
NIAi
Centers for Medicare
CMS68
Specifications,
aged 18 years and older for
130
Process
NIA
vl4
MIPS CQM
which the eligible clinician
& Medicaid Services
Specifications
attests to documenting a list of
current medications using all
immediate resources available
on the date of the encounter.
Preventive Care and
Screening: Tobacco Use:
Screening and Cessation
Intervention:
Medicare Part
Percentage of patients aged 12
B Claims
years and older who were
Measure
screened for tobacco use one or
NIAi
CMS13
Specifications,
National Committee
226
Process
more times during the
for Quality Assurance
NIA
8v13
eCQM
measurement period AND who
Specifications,
received tobacco cessation
MIPS CQM
intervention during the
Specifications
measurement period or in the 6
months prior to the
measurement period if identified
as a tobacco user.
Sentinel Lymph Node Biopsy
for Invasive Breast Cancer:
The percentage of clinically
node negative (clinical stage
NIAi
MIPS CQM
American Society of
TlN0M0 or T2N0M0) breast
264
NIA
Process
Breast Surgeons
NIA
Specifications
cancer patients before or after
neoadjuvant systemic therapy,
who undergo a sentinel lymph
node (SLN) orocedure.
62340
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8.15. General Surgery
NIAi
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317
CMS22
v13
!
(Outcome)
NIAi
NIA
354
NIA
MIPSCQM
Specifications
Outcome
§
!
(Outcome)
NIAi
NIA
355
NIA
MIPSCQM
Specifications
Outcome
!
(Outcome)
NIAi
NIA
356
NIA
MIPSCQM
Specifications
Outcome
!
(Outcome)
NIAi
NIA
357
NIA
MIPSCQM
Specifications
Outcome
!
(Patient
Experience)
NIAi
NIA
358
NIA
MIPSCQM
Specifications
Process
374
CMS50
vl3
eCQM
Specifications,
MIPSCQM
Specifications
Process
Process
*
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!
(Care
Coordination)
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Centers for Medicare
& Medicaid Services
American College of
Surgeons
American College of
Surgeons
American College of
Surgeons
American College of
Surgeons
American College of
Surgeons
Centers for Medicare
& Medicaid Services
EP31JY24.296
*
Medicare Part
BClaims
Measure
Specifications,
eCQM
Specifications,
MIPSCQM
Specifications
Preventive Care and
Screening: Screening for High
Blood Pressure and FollowUp Documented:
Percentage of patient visits for
patients aged 18 years and older
seen during the measurement
period who were screened for
high blood pressure AND a
recommended follow-up plan is
documented, as indicated, if
blood pressure is elevated or
h ertensive.
Anastomotic Leak
Intervention:
Percentage of patients aged 18
years and older who required an
anastomotic leak intervention
following gastric bypass or
colectom sur e
Unplanned Reoperation
within the 30-Day
Postoperative Period:
Percentage of patients aged 18
years and older who had any
unplanned reoperation within
the 30-da osto erative eriod.
Unplanned Hospital
Readmission within 30 Days
of Principal Procedure:
Percentage of patients aged 18
years and older who had an
unplanned hospital readmission
within 30 days of principal
rocedure.
Surgical Site Infection (SSI):
Percentage of patients aged 18
years and older who had a
sur ical site infection SSI .
Patient-Centered Surgical
Risk Assessment and
Communication:
Percentage of patients who
underwent a non-emergency
surgery who had their
personalized risks of
postoperative complications
assessed by their surgical team
prior to surgery using a clinical
data-based, patient-specific risk
calculator and who received
personal discussion of those
risks with the sur eon.
Closing the Referral Loop:
Receipt of Specialist Report:
Percentage of patients with
referrals, regardless of age, for
which the referring clinician
receives a report from the
clinician to whom the patient
was referred.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
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!
(Equity)
Screening for Social Drivers
of Health:
Percent of patients 18 years and
older screened for food
insecurity, housing instability,
transportation needs, utility
difficulties, and interpersonal
safet .
Connection to Community
Service Provider:
Percent of patients 18 years or
older who screen positive for
one or more of the following
health related social needs
(HRSNs): food insecurity,
housing instability,
transportation needs, utility help
needs, or interpersonal safety;
and had contact with a
Community Service Provider
(CSP) for at least one of their
HRSNs within 60 days after
screenin .
62342
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8.16. Geriatrics
In addition to the considerations discussed in the introductory language of Table Group B of this Appendix to this proposed rule,
the Geriatrics specialty set takes additional criteria into consideration, which includes, but is not limited to: whether a measure
reflects current clinical guidelines, and the coding of the measure includes relevant clinician types. We may reassess the
appropriateness of individual measures, on a case-by-case basis, to ensure appropriate inclusion in the specialty set. Measure
tables in this set include previously finalized measures we are maintaining within the set, measures proposed to be added, and
measures proposed for removal, as applicable. We request comment on the measures available in the proposed Geriatrics
specialty set.
B.16. Geriatrics
NIA
039
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Process
03261
NIA
047
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Medicare Part
BClaims
Measure
Specifications,
MIPSCQM
Specifications
NIAi
NIA
048
NIA
MIPSCQM
Specifications
Process
NIAi
NIA
050
NIA
MIPSCQM
Specifications
Process
NIAi
NIA
!30
CMS68v
14
eCQM
Specifications,
MfPSCQM
Specifications
*
!
(Care
Coordination
)
!
(Patient
Experience)
*
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!
(Patient
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Screening for Osteoporosis
for Women Aged 65-85
Years of Age:
Percentage of women aged
65-85 years of age who ever
had a central dual-energy Xray absorptiometry (DXA) to
check for osteo orosis.
Advance Care Plan:
Percentage of patients aged
65 years and older who have
an advance care plan or
surrogate decision maker
documented in the medical
record or documentation in
the medical record that an
advance care plan was
discussed but the patient did
not wish or was not able to
name a surrogate decision
maker or provide an advance
care Ian.
Urinary Incontinence:
Assessment of Presence or
Absence of Urinary
Incontinence in Women
Aged 65 Years and Older:
Percentage of female patients
aged 65 years and older who
were assessed for the
presence or absence of
urinary incontinence within
12months.
Urinary Incontinence: Plan
of Care for Urinary
Incontinence in Women
Aged 65 Years and Older:
Percentage of female patients
aged 65 years and older with
a diagnosis of urinary
incontinence with a
documented plan of care for
urinary incontinence at least
once within 12 months.
Documentation of Current
Medications in the Medical
Record:
Percentage of visits for
patients aged 18 years and
older for which the eligible
clinician attests to
documenting a list of current
medications using all
immediate resources
available on the date of the
encounter.
E:\FR\FM\31JYP2.SGM
31JYP2
National Committee
for Quality Assurance
National Committee
for Quality Assurance
National Committee
for Quality Assurance
National Committee
for Quality Assurance
Centers for Medicare &
Medicaid Services
EP31JY24.298
00461
Medicare Part
B Claims
Measure
Specifications,
MIPSCQM
Specifications
62343
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B.16. Geriatrics
· PREVJOUSLY F.INALIZED MEASURES lN THE.GERIATRICS SPECIA;LTY SET .
'
lnditator
.
.
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Qilality
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•.··
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eCQM
•
.
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*
!
(Patient
Safety)
*
0022
I
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Specifications,
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Specifications
Process
181
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Medicare Part
B Claims
Measure
Specifications,
MIPS CQM
Specifications
Process
238
CMS156
v13
eCQM
Specifications,
MIPS CQM
Specifications
Process
281
CMS149
vl3
eCQM
Specifications
Process
282
NIA
MIPS CQM
Specifications
Process
CMS2vl
4
155
*
NIAi
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Type··
Process
134
)
!
(Patient
Safety)
Meijsur¢ .•
Medicare Part
B Claims
Measure
Specifications,
eCQM
Specifications,
MIPS CQM
Specifications
*
!
(Care
Coordination
.C:otleet.ion
Type.
.
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.••
•'
>
.
.
•.•
Measitr~ Title.
and Des1:riptlou
·..
.
Preventive Care and
Screening: Screening for
Depression and Follow-Up
Plan:
Percentage of patients aged
12 years and older screened
for depression on the date of
the encounter or up to 14
days prior to the date of the
encounter using an ageappropriate standardized
depression screening tool
AND if positive, a follow-up
plan is documented on the
date of or up to 2days after
the date of the qualifying
encounter.
Falls: Plan of Care:
Percentage of patients aged
65 years and older with a
history of falls who had a
plan of care for falls
documented within 12
months.
Elder Maltreatment Screen
and Follow-lip Plan:
Percentage of patients aged
60 years and older with a
documented elder
maltreatment screen using an
Elder Maltreatment
Screening tool on the date of
encounter AND a
documented follow-up plan
on the date of the positive
screen.
lJ se of High-Risk
Medications in Older
Adults:
Percentage of patients 65
years of age and older who
were ordered at least two
high-risk medications from
the same drug class.
Dementia: Cognitive
Assessment:
Percentage of patients,
regardless of age, with a
diagnosis of dementia for
whom an assessment of
cognition is performed and
the results reviewed at least
once within a 12-month
period.
Dementia: Functional
Status Assessment:
Percentage of patients with
dementia for whom an
assessment of functional
status was performed at least
once in the last 12 months.
E:\FR\FM\31JYP2.SGM
31JYP2
'
.,.
'
..·
·.. •
' .•• .
Measu:te Steward
·.. •..
..
Centers for Medicare &
Medicaid Services
National Committee
for Quality Assurance
Centers for Medicare &
Medicaid Services
National Committee
for Quality Assurance
American Academy of
Neurology
American Academy of
Neurology/ American
Psychiatric Association
EP31JY24.299
.•··. •.
62344
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8.16. Geriatrics
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(Patient
Safety)
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Depression Remission at
Twelve Months:
The percentage of adolescent
patients 12 to 17 years ofage
and adult patients 18 years of
age or older with major
depression or dysthymia who
reached remission 12 months
(+I- 60 days) after an index
event date.
Urinary Symptom Score
Change 6-12 Months After
Diagnosis of Benign
Prostatic Hyperplasia:
Percentage of patients with
an office visit within the
measurement period and with
a new diagnosis of clinically
significant Benign Prostatic
Hyperplasia who have
International Prostate
Symptoms Score (IPSS) or
American Urological
Association (AUA)
Symptom Index (SI)
documented at time of
diagnosis and again 6-12
months later with an
im rovement of 3 oints.
E:\FR\FM\31JYP2.SGM
31JYP2
American Psychiatric
Association/ American
Academy of Neurology
American Academy of
Neurology I American
Psychiatric Association
National Committee for
Quality Assurance
Minnesota Community
Measurement
Large Urology Group
Practice Association
and Oregon Urology
Institute
EP31JY24.300
•
Dementia: Safety Concern
Screening and Follow-Up
for Patients with Dementia:
Percentage of patients with
dementia or their caregiver(s)
for whom there was a
documented safety concerns
screening in two domains of
risk: (1) dangerousness to
self or others and (2)
environmental risks; and if
safety concerns screening
was positive in the last 12
months, there was
documentation of mitigation
recommendations, including
but not limited to referral to
other resources.
Dementia: Education and
Support of Caregivers for
Patients with Dementia:
Percentage of patients with
dementia whose caregiver(s)
were provided with education
on dementia disease
management and health
behavior changes AND were
referred to additional
resources for support in the
last 12 months.
Falls: Screening for Future
Fall Risk:
Percentage of patients 65
years of age and older who
were screened for future fall
risk during the measurement
period.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
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B.16. Geriatrics
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Centers for Medicare &
Medicaid Services
National Kidney
Foundation
Renal Physicians
Association
National Committee
for Quality Assurance
Centers for Medicare
and Medicaid Services
EP31JY24.301
NIAi
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!
(Equity
Screening for Social
Drivers of Health:
Percent of patients 18 years
and older screened for food
insecurity, housing
instability, transportation
needs, utility difficulties, and
inte ersonal safe
Kidney Health Evaluation:
Percentage of patients aged
18-75 years with a diagnosis
of diabetes who received a
kidney health evaluation
defined by an Estimated
Glomerular Filtration Rate
(eGFR) AND Urine
Albumin-Creatinine Ratio
(uACR) within the
measurement riod.
Adult Kidney Disease:
Angiotensin Converting
Enzyme (ACE) Inhibitor or
Angiotensin Receptor
Blocker (ARB) Therapy:
Percentage of patients aged
18 years and older with a
diagnosis of chronic kidney
disease (CKD) (Stages 1-5,
not receiving Renal
Replacement Therapy
(RRT)) and proteinuria who
were prescribed ACE
inhibitor or ARB therapy
within a 12-month eriod.
Adult Immunization
Status:
Percentage of patients 19
years of age and older who
are up-to-date on
recommended routine
vaccines for influenza;
tetanus and diphtheria (Td)
or tetanus, diphtheria and
acellular pertussis (Tdap );
zoster and neumococcal.
Preventive Care and
Wellness (composite):
Percentage of patients who
received age- and sexappropriate preventive
screenings and wellness
services. This measure is a
composite of seven
component measures that are
based on recommendations
for preventive care by the
U.S. Preventive Services
Task Force (USPSTF),
ACIP, American Association
of Clinical Endocrinology
(AACE), and American
College of Endocrinology
ACE.
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OCHIN
EP31JY24.302
*
Connection to Community
Service Provider:
Percent of patients 18 years
or older who screen positive
for one or more of the
following health related
social needs (HRSNs): food
insecurity, housing
instability, transportation
needs, utility help needs, or
interpersonal safety; and had
contact with a Community
Service Provider (CSP) for at
least 1 of their HRSNs within
60 da s after screenin .
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62347
B.16. Geriatrics
!
87
88
VerDate Sep<11>2014
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N/A
495
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PatientReported
OutcomeBased
Performance
Measure
America
n
Academy
of
Hospice
and
Palliative
Medicine
(AAHP
M)
See footnote Ki lie et al., 2020 in Table B.4a of this Appendix.
See footnote National Consensus Project for Quality Palliative Care, 2018 in Table B.4a of this Appendix.
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)
MIPS
CQM
Specificati
ons
Ambulatory
Palliative
Care Patients'
Experience of
Feeling Heard
and
Understood:
The percentage
of top-box
responses
among patients
aged 18 years
and older who
had an
ambulatory
palliative care
visit and report
feeling heard
and understood
by their
palliative care
clinician and
team within 2
months (60
days) of the
ambulatory
palliative care
visit.
We are proposing to include this
measure in the Geriatrics specialty
set as it would be clinically
relevant to this clinician type.
This PRO-PM would help to fill a
gap for patients receiving
palliative care by capturing the
patient's voice and experience of
care by assessing communication
and shared decision making with
the clinician. This is an important
patient-centered measure that
helps patients feel heard and
understood which can effectively
improve the quality of care
received and outcomes for
patients in palliative care.
Allowing patients to feel heard
and understood adds an important
dimension to the care planning for
this unique patient population
commonly cared for by clinicians
in this specialty. As more patients
are living longer with multiple
comorbidities, especially true for
the advanced heart disease patient
population, early emergence of
palliative care into the overall
care of cardiac patients can
notably improve their quality of
life, patient satisfaction, and
reduction in symptoms. 87 This
measure is predicated on existing
guidelines and conceptual
models 88 and can facilitate and
improve effective patient-clinician
communication that engenders
trust, acknowledgement, and a
whole-person orientation to the
care that is provided. Through the
benefits of enhanced patientprovider communication, this
measure would improve the
quality of care received and
outcomes for patients receiving
palliative care. The measure being
added to this specialty set would
be contingent on the inclusion of
applicable coding by the time of
the CY 2025 PFS final rule.
62348
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B.16. Geriatrics
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!
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CQM
Specificati
ons
PatientReported
OutcomeBased
Performance
Measure
Insignia
Health,
LLC,a
wholly
owned
subsidiar
yof
Phreesia
We are proposing to include this
measure in the Geriatrics specialty
set as it would be clinically
relevant to this clinician type. The
addition of this measure to this
specialty set would be feasible
given its use through the
continuum of care and across
different clinical settings. This
measure addresses chronic
conditions and outcomes, both of
which are high priority areas for
measure consideration for MIPS.
It is utilized in research within the
U.S. and internationally and has
also been shown to be valid and
reliable in different clinical
settings and under different
payment models. 89 The measure
being added to this specialty set
would be contingent on the
inclusion ofapplicable coding by
the time of the CY 2025 PFS final
rule.
See footnote Phreesia, 2024 in Table B.7 of this Appendix.
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Gains in
Patient
Activation
Measure
(PAM®)
Scores at 12
Months:
The Patient
Activation
Measure®
(PAM®) is a
10-or13item
questionnaire
that assesses an
individual's
knowledge,
skills and
confidence for
managing their
health and
health care.
The measure
assesses
individuals on
a 0-100 scale
that converts to
one of four
levels of
activation,
from low (I) to
high (4). The
PAM®
performance
measure
(PAM®-PM) is
the change in
score on the
PAM®from
baseline to
follow-up
measurement.
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90
91
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for
Medicare
&
Medicaid
Services
See footnote lkeokwu et al., 2023 in Table B.l of this Appendix.
See footnotes Fitzpatrick et al., 2022; Polack et al., 2020; and Grafia et al., 2022 in Table A.5 of this Appendix.
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Specificati
ons
Adult
COVID-19
Vaccination
Status:
Percentage of
patients aged
18 years and
older seen for a
visit during the
performance
period that are
up-to-date on
their COVID19 vaccinations
as defined by
CDC
recommendatio
ns on current
vaccination.
We are proposing to include this
measure in the Geriatrics specialty
set as it would be clinically
relevant to this clinician type.
Widespread vaccination against
SARS-CoV-2, the virus that
causes CO VlD-19, is critically
important to stemming the
morbidity and mortality caused by
this disease. 90 Clinicians are
uniquely positioned to encourage
uptake of COVID-19 vaccination,
and clinicians are still a major
driving force in promoting patient
vaccination. The addition of this
quality measure in this specialty
set would help strengthen
compliance with recommended
COVID-19 vaccination, leading to
improvement in the quality of
patient care and prevention of
disease for the general population.
This quality measure aligns with
clinical guidelines and the
evidence-based recommendations
of the ACIP, where there is
general agreement about the
safety and efficacy of the
COVID-19 vaccine, preventing
costly and potentially harmful
hospitalizations. 91 Broadening
vaccination status awareness to
this clinician type is valuable as it
can help drive an increase in the
adult vaccination rates. The
COVID-19 vaccination included
within this measure would reduce
the prevalence of severe diseases
that may be associated with
hospitalization and decrease
overall health care costs. The
measure being added to this
specialty set would be contingent
on the inclusion of applicable
coding by the time of the CY
2025 PFS final rule. In the event
appropriate coding is not included
in the final specification, this
measure would not be finalized
for inclusion within this specialty
mea~ure set. See Table A.5 of this
Appendix for rationale, including
clinical evidence supporting the
inclusion of this measure in
MIPS.
62350
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B.17. Hospitalists
In addition to the considerations discussed in the introductory language of Table Group B of this Appendix to this proposed rule,
the Hospitalists specialty set takes additional criteria into consideration, which includes, but is not limited to: whether a measure
reflects current clinical guidelines, and the coding of the measure includes relevant clinician types. We may reassess the
appropriateness of individual measures, on a case-by-case basis, to ensure appropriate inclusion in the specialty set. Measure
tables in this set include previously finalized measures we are maintaining within the set, measures proposed to be added, and
measures proposed for removal, as applicable. We request comment on measures available in the proposed Hospitalists specialty
set that have proposed substantive changes in Table Group D of this Appendix as indicated by an * in the Indicator column.
B.17. Hospitalists
0081 /
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American Heart
Association
American Heart
Association
National Committee
for Quality Assurance
EP31JY24.306
§
Heart Failure (HF):
Angiotensin-Converting
Enzyme (ACE) Inhibitor or
Angiotensin Receptor
Blocker (ARB) or
Angiotensin ReceptorNeprilysin Inhibitor (ARNI)
Therapy for Left
Ventricular Systolic
Dysfunction (LVSD):
Percentage of patients aged
18 years and older with a
diagnosis of heart failure
(HF) with a current or prior
left ventricular ejection
fraction (L VEF) :5 40% who
were prescribed ACE
inhibitor or ARB or ARNI
therapy either within a 12month period when seen in
the outpatient setting OR at
each hos ital dischar e.
Heart Failure (HF): BetaBlocker Therapy for Left
Ventricular Systolic
Dysfunction (LVSD):
Percentage of patients aged
18 years and older with a
diagnosis of heart failure
(HF) with a current or prior
letl ventricular ejection
fraction (L VEF) :5 40% who
were prescribed beta-blocker
therapy either within a 12month period when seen in
the outpatient setting OR at
each hos ital dischar e.
Advance Care Plan:
Percentage of patients aged 65
years and older who have an
advance care plan or surrogate
decision maker documented in
the medical record or
documentation in the medical
record that an advance care
plan was discussed but the
patient did not wish or was not
able to name a surrogate
decision maker or provide an
advance care Ian.
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Medicaid Services
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§
!
(Patient
Safety)
Documentation of Current
Medications in the Medical
Record:
Percentage of visits for
patients aged 18 years and
older for which the eligible
clinician attests to
documenting a list of current
medications using all
immediate resources available
on the date of the encounter.
62352
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
B.18. Infectious Disease
In addition to the considerations discussed in the introductory language of Table Group B of this Appendix to this proposed rule,
the Infectious Disease specialty set takes additional criteria into consideration, which includes, but is not limited to: whether a
measure reflects current clinical guidelines, and the coding of the measure includes relevant clinician types. We may reassess the
appropriateness of individual measures, on a case-by-case basis, to ensure appropriate inclusion in the specialty set. Measure
tables in this set include previously finalized measures we are maintaining within the set, measures proposed to be added, and
measures proposed for removal, as applicable. We request comment on the measures available in the proposed Infectious Disease
specialty set.
8.18. Infectious Disease
0069 I
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National Committee for
Quality Assurance
National Committee for
Quality Assurance
Centers for Medicare &
Medicaid Services
American College of
Rheumatology
Health Resources and
Services Administration
National Committee for
Quality Assurance
EP31JY24.308
§
!
(Appropria
te Use)
Appropriate Treatment for
Upper Respiratory Infection
(URI):
Percentage of episodes for
patients 3 months ofage and
older with a diagnosis of upper
respiratory infection (URI) that
did not result in an antibiotic
order.
Appropriate Testing for
Pharyngitis:
The percentage of episodes for
patients 3 years and older with a
diagnosis of pharyngitis that
resulted in an antibiotic order on
or within 3 days after the
episode date and a group A
Streptococcus (Strep) test in the
7-day period from three days
prior to the episode date through
3 da s after the e isode date.
Documentation of Current
Medications in the Medical
Record:
Percentage of visits for patients
aged 18 years and older for
which the eligible clinician
attests to documenting a list of
current medications using all
immediate resources available
on the date of the encounter.
Tuberculosis Screening Prior
to First Course of Biologic
and/or Immune Response
Modifier Therapy:
Ifa patient has been newly
prescribed a biologic and/or
immune response modifier that
includes a warning for potential
reactivation of a latent infection,
then the medical record should
indicate TB testing in the
recedin 12-month riod.
Sexually Transmitted
Infection (STI) Testing for
People with HIV:
Percentage of patients 13 years
of age and older with a diagnosis
of HIV who had tests for
syphilis, gonorrhea, and
chlamydia performed within the
erforrnance eriod.
Preventive Care and
Screening: Tobacco Use:
Screening and Cessation
Intervention:
Percentage of patients aged 12
ears and older who were
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
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Specifications
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4v2
eCQM
Specifications,
MIPSCQM
Specifications
Outcome
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NIA
MIPSCQM
Specifications
Process
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screened for tobacco use one or
more times during the
measurement period AND who
received tobacco cessation
intervention during the
measurement period or in the 6
months prior to the measurement
period if identified as a tobacco
user.
Childhood Immunization
Status:
Percentage of children 2 years of
age who had four diphtheria,
tetanus and acellular pertussis
(DtaP); three polio (IPV), one
measles, mumps and rubella
(MMR); three or four H
influenza type B (HiB); three
hepatitis B (HepB); one chicken
pox (VZV); four pneumococcal
conjugate (PCV); one hepatitis
A (HepA); two or three rotavirus
(RV); and two influenza (flu)
vaccines by their second
birthda .
HIV Viral Suppression:
Percentage of patients,
regardless of age, diagnosed
with HIV prior to or during the
first 90 days of the performance
period, with an eligible
encounter in the fust 240 days of
the performance period, whose
last HIV viral load test result
was less than 200 copies/mL
durin the erformance eriod.
HIV Medical Visit Frequency:
Percentage of patients,
regardless of age with a
diagnosis of HIV who had at
least one medical visit in each 6month period of the 24-month
measurement period, with a
minimum of60 days between
medical visits.
Annual Hepatitis C Virus
(HCV) Screening for Patients
who are Active Injection Drug
Users:
Percentage of patients,
regardless of age, who are active
injection drug users who
received screening for HCV
infection within the 12-month
re ortin eriod.
Immunizations for
Adolescents:
The percentage of adolescents
13 years of age who had one
dose ofmeningococcal vaccine
(serogroups A, C, W, Y}, one
tetanus, diphtheria toxoids and
acellular pertussis (Tdap)
vaccine, and have completed the
Human Papillomavirus (HPV)
vaccine series by their 13••
birthda .
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National Committee for
Quality Assurance
Health Resources and
Services Administration
Health Resources and
Services Administration
American
Gastroenterological
Association
National Committee for
Quality Assurance
EP31JY24.309
MIPSCQM
Specifications
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B.18. Infectious Disease
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HIV Screening:
Percentage of patients aged 1565 at the start of the
measurement period who were
between 15-65 years old when
tested for Human
Immunodeficiency Virus (HIV).
Screening for Social Drivers of
Health:
Percent of patients 18 years and
older screened for food
insecurity, housing instability,
transportation needs, utility
difficulties, and interpersonal
safetv.
Adult Immunization Status:
Percentage of patients 19 years
of age and older who are up-todate on recommended routine
vaccines for influenza; tetanus
and diphtheria (Td) or tetanus,
diphtheria and acellular pertussis
(T dap ); zoster; and
pneumococcaL
Connection to Community
Service Provider:
Percent of patients 18 years or
older who screen positive for
one or more of the following
health related social needs
(HRSNs): food insecurity,
housing instability,
transportation needs, utility help
needs, or interpersonal safety;
and had contact with a
Community Service Provider
(CSP) for at least 1 of their
HRSNs within 60 days after
screening.
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..
Centers for Disease
Control and Prevention
Centers for Medicare &
Medicaid Services
National Committee for
Quality Assurance
OCHIN
EP31JY24.310
Indicator .•
PREVIOl/SLY FINALIZED MEASURES IN THE INFECTlOl/S DISEASE SPECIALTY SET
Measur
CBE#/
CMS
Collection
e
Meas.ure Title
Quality
Measure Steward
eCQM
eCQM
Type
Type
aud Description
#
CBE#
ID
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62355
B.18. Infectious Disease
(Outcome
24831
NIA
503
92
PatientReported
OutcomeBased
Performanc
e Measure
Insignia
Health,
LLC,a
wholly
owned
subsidiar
yof
Phreesia
We are proposing to include this
measure in the Infectious Disease
specialty set as it would be
clinically relevant to this clinician
type. The addition of this measure
to this specialty set would be
feasible given its use through the
continuum of care and across
different clinical settings. This
measure addresses chronic
conditions and outcomes, both of
which are high priority areas for
measure consideration for MIPS.
It is utilized in research within the
U.S. and internationally and has
also been shown to be valid and
reliable in different clinical
settings and under different
payment models. 92 The measure
being added to this specialty set
would be contingent on the
inclusion of applicable coding by
the time of the CY 2025 PFS final
rule.
See footnote Phreesia, 2024 in Table B.7 of this Appendix.
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)
NIA
MIPS
CQM
Specificati
ons
Gains in Patient
Activation
Measure
(PAM®) Scores
at 12 Months:
The Patient
Activation
Measure®
(PAM®) is a 10
-or 13-item
questionnaire
that assesses an
individual's
knowledge, skills
and confidence
for managing
their health and
health care. The
measure assesses
individuals on a
0-100 scale that
converts to one
of four levels of
activation, from
low(l)to high
(4). The PAM®
performance
measure
(PAM®-PM) is
the change in
score on the
PAM®from
baseline to
follow-up
measurement.
62356
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B.18. Infectious Disease
93
94
TBD
NIA
Process
Centers
for
Medicare
&
Medicaid
Services
See footnote lkeokwu et al., 2023 in Table B.l of this Appendix.
See footnotes Fitzpatrick et al., 2022; Polack et al., 2020; and Grana et al., 2022 in Table A.5 of this Appendix.
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MIPS
CQM
Specificati
ons
Adult COVID19 Vaccination
Status:
Percentage of
patients aged 18
years and older
seen for a visit
during the
performance
period that are
up-to-date on
their COVJD-19
vaccinations as
defined by CDC
recommendation
son current
vaccination.
We are proposing to include this
measure in the Infectious Disease
specialty set as it would be
clinically relevant to this clinician
type. Widespread vaccination
against SARS-CoV-2, the virus
that causes COVID-19, is
critically important to stemming
the morbidity and mortality
caused by this disease. 93
Clinicians are uniquely positioned
to encourage uptake ofCOVID19 vaccination, and clinicians are
still a major driving force in
promoting patient vaccination.
The addition of this quality
measure in this specialty set
would help strengthen compliance
with recommended COVID-19
vaccination, leading to
improvement in the quality of
patient care and prevention of
disease for the general population.
This quality measure aligns with
clinical guidelines and the
evidence-based recommendations
of the ACIP, where there is
general agreement about the
safety and efficacy of the
COVID-19 vaccine, preventing
costly and potentially harmful
hospitalizations. 94 Broadening
vaccination status awareness to
this clinician type is valuable as it
can help drive an increase in the
adult vaccination rates. The
COVID-19 vaccination included
within this measure would reduce
the prevalence of severe diseases
that may be associated with
hospitalization and decrease
overall health care costs. The
measure being added to this
specialty set would be contingent
on the inclusion of applicable
coding by the time of the CY
2025 PFS final rule. In the event
appropriate coding is not included
in the final specification, this
measure would not be fmalized
for inclusion within this specialty
measure set. See Table A.5 of this
Appendix for rationale, including
clinical evidence supporting the
inclusion of this measure in
MIPS.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62357
B.19. Internal Medicine
In addition to the considerations discussed in the introductory language of Table Group B of this Appendix to this proposed rule,
the Internal Medicine specialty set takes additional criteria into consideration, which includes, but is not limited to: whether a
measure reflects current clinical guidelines, and the coding of the measure includes relevant clinician types. We may reassess the
appropriateness of individual measures, on a case-by-case basis, to ensure appropriate inclusion in the specialty set. Measure
tables in this set include previously finalized measures we are maintaining within the set, measures proposed to be added, and
measures proposed for removal, as applicable. We request comment on the measures available in the proposed Internal Medicine
specialty set.
B.19. Internal Medicine
Intermediate
Outcome
eCQM
CMS135v Specifications,
MIPS CQM
13
Specifications
Process
MIPS CQM
Specifications
Process
eCQM
CMS145v Specifications.
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Diabetes: Hemoglobin Ale
(HbAJc) Poor Control
(>9%):
Percentage of patients 18-75
years of age with diabetes
who had hemoglobin Ale >
9.0% during the
measurement eriod.
Heart Failure (HF):
Angiotensin-Converting
Enzyme (ACE) Inhibitor or
Angiotensin Receptor
Blocker (ARB) or
Angiotensin ReceptorNeprilysin Inhibitor
(ARNI) Therapy for Left
Ventricular Systolic
Dysfunction (LVSD):
Percentage of patients aged
I 8 years and older with a
diagnosis of heart failure
(HF) with a current or prior
left ventricular ejection
fraction (L VEF) S 40% who
were prescribed ACE
inhibitor or ARB or ARNT
therapy either within a 12month period when seen in
the outpatient setting OR at
each hos ital dischar e.
Coronary Artery Disease
(CAD): Antiplatelet
Therapy:
Percentage of patients aged
18 years and older with a
diagnosis of coronary artery
disease (CAD) seen within a
12-month period who were
prescribed aspirin or
clo ido rel.
Coronary Artery Disease
(CAD): Beta-Blocker
Therapy - Prior
Myocardial Infarction
(MI) or Left Ventricular
Systolic Dysfunction
(LVEF S 40%):
Percentage of patients aged
18 years and older with a
diagnosis of coronary artery
disease seen within a 12month period who also
have a prior MI or a current
or prior LVEF S 40% who
were prescribed betablocker thcra
E:\FR\FM\31JYP2.SGM
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American Heart
Association
American Heart
Association
American Heart
Association
EP31JY24.313
001
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Claims Measure
Specifications,
CMS122v
eCQM
13
Specifications,
MIPS CQM
Specifications
*
62358
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American Heart
Association
National Committee
for Quality Assurance
National Committee for
Quality Assurance
EP31JY24.314
§
0083 I
0083e
Heart Failure (HF): BetaBlocker Therapy for Left
Ventricular Systolic
Dysfunction (LVSD):
Percentage of patients aged
18 years and older with a
diagnosis of heart failure
(HF) with a current or prior
left ventricular ejection
fraction (LVEF) ::; 40%
who were prescribed betablocker therapy either
within a 12-month period
when seen in the outpatient
setting OR at each hospital
dischar e.
Antidepressant
Medication Management:
Percentage of patients 18
years of age and older who
were treated with
antidepressant medication,
had a diagnosis of major
depression, and who
remained on an
antidepressant medication
treatment. Two rates are
reported.
a. Percentage of patients
who remained on an
antidepressant medication
for at least 84 days (12
weeks).
b. Percentage of patients
who remained on an
antidepressant medication
for at least 180 days (6
months.
Communication with the
Physician or Other
Clinician Managing OnGoing Care Post-Fracture
for Men and Women Aged
50 Years and Older:
Percentage of patients aged
50 years and older treated
for a fracture with
documentation of
communication, between
the physician treating the
fracture and the physician
or other clinician managing
the patient's on-going care,
that a fracture occurred and
that the patient was or
should be considered for
osteoporosis treatment or
testing. This measure is
submitted by the physician
who treats the fracture and
who therefore is held
accountable for the
communication.
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62359
B.19. Internal Medicine
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Specifications,
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Process
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*
!
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Coordinat
ion)
!
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Experienc
e)
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047
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Claims Measure
Specifications,
MIPSCQM
Specifications
NIAi
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MTPSCQM
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Process
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Specifications
Process
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Quality Assurance
National Committee
for Quality Assurance
National Committee
for Quality Assurance
National Committee
for Quality Assurance
National Committee
for Quality Assurance
EP31JY24.315
00461
NIA
Screening for
Osteoporosis for Women
Aged 65-85 Years of Age:
Percentage of women aged
65-85 years ofage who
ever had a central dualenergy X-ray
absorptiometry (DXA) to
check for osteo orosis.
Advance Care Plan:
Percentage of patients aged
65 years and older who
have an advance care plan
or surrogate decision maker
documented in the medical
record or documentation in
the medical record that an
advance care plan was
discussed but the patient
did not wish or was not
able to name a surrogate
decision maker or provide
an advance care Ian.
Urinary Incontinence:
Assessment of Presence or
Absence of Urinary
Incontinence in Women
Aged 65 Years and Older:
Percentage of female
patients aged 65 years and
older who were assessed
for the presence or absence
of urinary incontinence
within 12 months.
Urinary Incontinence: Plan
of Care for Urinary
Incontinence in Women
Aged 65 Years and Older:
Percentage of female
patients aged 65 years and
older with a diagnosis of
urinary incontinence with a
documented plan of care
for urinary incontinence at
least once within 12
months.
Avoidance of Antibiotic
Treatment for Acute
Bronchitis/Bronchiolitis:
The percentage of episodes
for patients ages 3 months
and older with a diagnosis
of acute
bronchitis/bronchiolitis that
did not result in an
antibiotic dis ensin event.
62360
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14
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Specifications,
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4
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Claims Measure
Specifications,
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Specifications,
MIPSCQM
Specifications
Process
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National Committee
for Quality Assurance
American Podiatric
Medical Association
Centers for Medicare
& Medicaid Services
Centers for Medicare
& Medicaid Services
National Committee
for Quality Assurance
EP31JY24.316
*
§
CMS131
vl3
0055 I
NIA
Diabetes: Eye Exam:
Percentage of patients 1875 years of age with
diabetes and an active
diagnosis of retinopathy in
any part of the
measurement period who
had a retinal or dilated eye
exam by an eye care
professional during the
measurement period or
diabetics with no diagnosis
ofretinopathy in any part of
the measurement period
who had a retinal or dilated
eye exam by an eye care
professional during the
measurement period or in
the 12 months prior to the
measurement eriod.
Diabetes Mellitus:
Diabetic Foot and Ankle
Care, Peripheral
Neuropathy Neurological Evaluation:
Percentage of patients aged
18 years and older with a
diagnosis of diabetes
mellitus who had a
neurological examination
of their lower extremities
within 12 months.
Documentation of
Current Medications in
the Medical Record:
Percentage of visits for
patients aged 18 years and
older for which the eligible
clinician attests to
documenting a list of
current medications using
all immediate resources
available on the date of the
encounter.
Preventive Care and
Screening: Screening for
Depression and FollowUp Plan:
Percentage of patients aged
12 years and older screened
for depression on the date
of the encounter or up to 14
days prior to the date of the
encounter using an ageappropriate standardized
depression screening tool
AND if positive, a followup plan is documented on
the date of or up to two
days after the date of the
uali in encounter.
.Falls: Plan of Care:
Percentage of patients aged
65 years and older with a
history of falls who had a
plan of care for falls
documented within 12
months.
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Specifications
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Outcome
Process
*
!
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Safety)
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181
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236
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v13
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Claims Measure
Specifications,
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Specifications,
MlPSCQM
Specifications
0022 I
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238
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American College of
Rheumatology
Centers for Medicare
& Medicaid Services
National Committee
for Quality Assurance
National Committee
for Quality Assurance
EP31JY24.317
*
Tuberculosis Screening
Prior to First Course of
Biologic and/or Immune
Response Modifier
Therapy:
If a patient has been newly
prescribed a biologic and/or
immune response modifier
that includes a warning for
potential reactivation of a
latent infection, then the
medical record should
indicate TB testing in the
recedin 12-month eriod.
Elder Maltreatment
Screen and Follow-Up
Plan:
Percentage of patients aged
60 years and older with a
documented elder
maltreatment screen using
an Elder Maltreatment
Screening tool on the date
of encounter AND a
documented follow-up plan
on the date of the positive
screen.
Controlling High Blood
Pressure:
Percentage of patients 1885 years of age who had a
diagnosis of essential
hypertension starting before
and continuing into, or
starting during the first six
months of the measurement
period, and whose most
recent blood pressure was
adequately controlled
(<140/90mmHg) during the
measurement eriod.
Use of High-Risk
Medications in Older
Adults:
Percentage of patients 65
years of age and older who
were ordered at least two
high-risk medications from
the same dru class.
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American Heart
Association
American Academy of
Sleep Medicine
American Academy of
Sleep Medicine
EP31JY24.318
!
(Care
Coordinat
ion)
Cardiac Rehabilitation
Patient Referral from an
Outpatient Setting:
Percentage of patients
evaluated in an outpatient
setting who within the
previous 12 months have
experienced an acute
myocardial infarction (MT),
coronary artery bypass graft
(CABG) surgery, a
percutaneous coronary
intervention (PCI), cardiac
valve surgery, or cardiac
transplantation, or who
have chronic stable angina
(CSA) and have not already
participated in an early
outpatient cardiac
rehabilitation/secondary
prevention (CR) program
for the qualifying
event/diagnosis who were
referred to a CR ro ram.
Sleep Apnea: Severity
Assessment at Initial
Diagnosis:
Percentage of patients aged
18 years and older with a
diagnosis of obstructive
sleep apnea who had an
apnea hypopnea index
(Al-Il), a respiratory
disturbance index (RDI), or
a respiratory event index
(REI) documented or
measured within 2 months
of initial evaluation for
suspected obstructive sleep
a nea.
Sleep Apnea: Assessment
of Adherence to
Obstructive Sleep Apnea
(OSA) Therapy:
Percentage of patients aged
18 years and older with a
diagnosis of obstructive
sleep apnea (OSA) that
were prescribed an
evidence-based therapy that
had documentation that
adherence to therapy was
assessed at least annually
through an objective
informatics system or
through self-reporting ( if
objective reporting is not
available.
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National Committee
for Quality Assurance
National Committee
for Quality Assurance
National Committee
for Quality Assurance
EP31JY24.319
NIA/NIA
!
(Opioid)
Initiation and
Engagement of Substance
Use Disorder Treatment:
Percentage of patients 13
years of age and older with
a new substance use
disorder (SUD) episode
who received the following
(Two rates are reported):
a. Percentage of patients
who initiated treatment,
including either an
intervention or medication
for the treatment of SUD,
within 14 days of the new
SUD episode.
b. Percentage of patients
who engaged in ongoing
treatment, including two
additional interventions or
medication treatment
events for SUD, or one
long-acting medication
event for the treatment of
SUD, within 34 days of the
initiation.
Cervical Cancer
Screening:
Percentage ofwomen 21-64
years of age who were
screened for cervical cancer
using either of the
following criteria:
• Women age 21-64 who
had cervical cytology
performed within the last 3
years
• Women age 30-64 who
had cervical human
papillomavirus (HPV)
testing performed within
the last 5 ears
Falls: Screening for
Future Fall Risk:
Percentage of patients 65
years of age and older who
were screened for future
fall risk during the
measurement eriod.
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Experience
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Centers for Medicare &
Medicaid Services
American Heart
Association
American Academy of
OtolaryngologyHead and Neck
Surgery Foundation
EP31JY24.320
§
!
CAHPS for MIPS
Clinician/Group Survey:
The Consumer Assessment
of Healthcare Providers and
Systems (CAHPS) for
MIPS Clinician/Group
Survey is comprised of 10
Summary Survey Measures
(SSMs) and measures
patient experience of care
within a group practice.
The CBE endorsement
status and endorsement id
( if applicable) for each
SSM utiliz.ed in this
measure are as follows:
• Getting Timely Care,
Appointments, and
Information; (Not endorsed
byCBE)
• How well Providers
Communicate; (Not
endorsed by CBE)
• Patient's Rating of
Provider; (CBE endorsed #
0005)
• Access to Specialists;
(Not endorsed by CBE)
• Health Promotion and
Education; (Not endorsed
byCBE)
• Shared Decision-Making;
(Not endorsed by CBE)
• Health Status and
Functional Status; (Not
endorsed by CBE)
• Courteous and Helpful
Office Staff; (CBE
endorsed # 0005)
• Care Coordination; (Not
endorsed by CBE)
• Stewardship of Patient
Resources. (Not endorsed
b CBE
Atrial Fibrillation and
Atrial Flutter: Chronic
Anticoagulation Therapy:
Percentage of patients aged
18 years and older with
atrial fibrillation (AF) or
atrial flutter who were
prescribed an FDAapproved oral anticoagulant
drug for the prevention of
thromboembolism during
the measurement eriod.
Adult Sinusitis: Antibiotic
Prescribed for Acute
Viral Sinusitis (Overuse):
Percentage of patients, aged
18 years and older, with a
diagnosis of acute viral
sinusitis who were
prescribed an antibiotic
within 10 days after onset
ofs m toms.
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§
!
(Outcome)
0710 I
0710e
370
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v13
eCQM
Specifications,
MIPSCQM
Specifications
Outcome
NIA/NIA
374
CMS50v
13
eCQM
Specifications,
MTPSCQM
Specifications
Process
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377
CMS90v
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Process
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American Academy of
Otolaryngology Head and Neck
Surgery Foundation
Health Resources and
Services
Administration
Minnesota
Community
Measurement
Centers for Medicare
& Medicaid Services
Centers for Medicare
& Medicaid Services
EP31JY24.321
!
(Appropri
ate Use)
Adult Sinusitis:
Appropriate Choice of
Antibiotic: Amoxicillin
With or Without
Clavulanate Prescribed
for Patients with Acute
Bacterial Sinusitis
(Appropriate Use):
Percentage of patients aged
18 years and older with a
diagnosis of acute bacterial
sinusitis that were
prescribed amoxicillin, with
or without clavulanate, as a
first line antibiotic at the
time of dia nosis.
HIV Viral Suppression:
Percentage of patients,
regardless of age,
diagnosed with HIV prior
to or during the first 90
days of the performance
period, with an eligible
encounter in the first 240
days of the performance
period, whose last HIV
viral load test result was
less than 200 copies/mL
during the performance
eriod.
Depression Remission at
Twelve Months:
The percentage of
adolescent patients 12 to 17
years of age and adult
patients 18 years of age or
older with major depression
or dysthymia who reached
remission 12 months(+/60 days) after an index
event date.
Closing the Referral
Loop: Receipt of
Specialist Report:
Percentage of patients with
referrals, regardless of age,
for which the referring
clinician receives a report
from the clinician to whom
the atient was referred.
Functional Status
Assessments for Heart
Failure:
Percentage of patients 18
years of age and older with
heart failure who completed
initial and follow-up
patient-reported functional
status assessments.
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Centers for Medicare
& Medicaid Services
American
Gastroenterological
Association
Minnesota Community
Measurement
American
Gastroenterological
Association
EP31JY24.322
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(Outcome
)
Adherence to
Antipsychotic
Medications for
Individuals with
Schizophrenia:
Percentage of individuals at
least 18 years of age as of
the beginning of the
performance period with
schizophrenia or
schizoaffective disorder
who had at least two
prescriptions filled for any
antipsychotic medication
and who had a Proportion
of Days Covered (PDC) of
at least 0.8 for
antipsychotic medications
during the performance
eriod.
Annual Hepatitis C Virus
(HCV) Screening for
Patients who are Active
Injection Drug Users:
Percentage of patients,
regardless of age, who are
active injection drug users
who received screening for
HCV infection within the
12-month re ortin eriod.
Optimal Asthma Control:
Composite measure of the
percentage of pediatric and
adult patients whose asthma
is well-controlled as
demonstrated by one of
three age appropriate
patient reported outcome
tools and not at risk for
exacerbation.
One-Time Screening for
Hepatitis C Virus (HCV)
and Treatment Initiation:
Percentage of patients age
>= 18 years have never
been tested for Hepatitis C
Virus (HCV) infection who
receive an HCV infection
test AND who have
treatment initiated within
three months or who are
referred to a clinician who
treats HCV infection within
one month if tested positive
forHCV.
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American
Gastroenterological
Association
National Committee
for Quality Assurance
National Committee
for Quality Assurance
EP31JY24.323
§
Hepatitis C: Screening for
Hepatocellnlar
Carcinoma (HCC) in
Patients with Cirrhosis:
Percentage of patients aged
18 years and older with a
diagnosis of chronic
Hepatitis C cirrhosis who
underwent imaging with
either ultrasound, contrast
enhanced CT or MRI for
hepatocellular carcinoma
(HCC) at least once within
the 12-month submission
eriod.
Osteoporosis
Management in Women
Who Had a Fracture:
The percentage of women
50-85 years of age who
suffered a fracture and who
had either a bone mineral
density (BMD) test or
prescription for a drug to
treat osteoporosis in the six
months after the fracture.
Preventive Care and
Screening: Unhealthy
Alcohol Use: Screening &
Brief Counseling:
Percentage of patients aged
18 years and older who
were screened for
unhealthy alcohol use using
a systematic screening
method at least once within
the last 12 months AND
who received brief
counseling if identified as
an unhealth alcohol user.
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eCQM
Specifications,
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Outcome
§
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Centers for Medicare
& Medicaid Services
Wisconsin
Collaborative for
Healthcare Quality
EP31JY24.324
§
Statin Therapy for the
Prevention and
Treatment or
Cardiovascular Disease:
Percentage of the following
patients - all considered at
high risk ofcardiovascular
events - who were
prescribed or were on statin
therapy during the
performance period:
• All patients who were
previously diagnosed with
or currently have a
diagnosis of clinical
atherosclerotic
cardiovascular disease
(ASCVD), including an
ASCVD procedure; OR
• Patients aged 20 to 75
years who have ever had a
low-density Iipoprotein
cholesterol (LDL-C) level:::
190 mg/dL or were
previously diagnosed with
or currently have an active
diagnosis of familial
hypercholesterolemia; OR
•Patients aged 40 to 75
years with a diagnosis of
diabetes; OR
• Patients aged 40 to 75
with a I 0-year ASCVD risk
score of::: 20 ercent.
Ischemic Vascular
Disease (IVD) All or None
Ontcome Measure
(Optimal Control):
The IVD All-or-None
Measure is one outcome
measure (optimal control).
The measure contains four
goals. All four goals within
a measure must be reached
in order to meet that
measure. The numerator for
the all-or-none measure
should be collected from
the organization's total IVD
denominator. All-or-None
Outcome Measure (Optimal
Control) - Using the TVD
denominator optimal results
include:
• Most recent blood
pressure (BP) measurement
is less than or equal to
140/90 mm Hg-- AND
• Most recent tobacco status
is Tobacco Free -- AND
• Daily Aspirin or Other
Antiplatclet Unless
Contraindicated -- AND
• Statin Use Unless
Contraindicated.
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Centers for Medicare
& Medicaid Services
University of Southern
California
Centers for Disease
Control and Prevention
Large Urology Group
Practice Association
and Oregon Urology
Institute
EP31JY24.325
§
!
(Appropri
ate Use)
Non-Recommended
Cervical Cancer
Screening in Adolescent
Females:
The percentage of
adolescent females 16--20
years of age who were
screened unnecessarily for
cervical cancer.
Continuity of
Pharmacotherapy for
Opioid Use Disorder
(OUD):
Percentage of adults aged
18 years and older with
pharmacotherapy for opioid
use disorder (OUD) who
have at least 180 days of
continuous treatment.
HIV Screening:
Percentage of patients aged
15-65 at the start of the
measurement period who
were between 15-65 years
old when tested for Human
Immunodeficiency Virus
HIV.
Urinary Symptom Score
Change 6-12 Months
After Diagnosis of Benign
Prostatic Hyperplasia:
Percentage of patients with
an office visit within the
measurement period and
with a new diagnosis of
clinically significant
Benign Prostatic
Hyperplasia who have
International Prostate
Symptoms Score (IPSS) or
American Urological
Association (AUA)
Symptom Index (SI)
documented at time of
diagnosis and again 6-12
months later with an
im rovement of 3 oints.
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Screening for Social
Drivers of Health:
Percent of patients 18 years
and older screened for food
insecurity, housing
instability, transportation
needs, utility difficulties,
and inte ersonal safe
Kidney Health
Evaluation:
Percentage of patients aged
18-75 years with a
diagnosis of diabetes who
received a kidney health
evaluation defmed by an
Estimated Glomerular
Filtration Rate (eGFR)
AND Urine AlbuminCreatinine Ratio (uACR)
within the measurement
eriod.
Adult Immunization
Status:
Percentage of patients 19
years of age and older who
are up-to-date on
recommended routine
vaccines for influenza;
tetanus and diphtheria (T d)
or tetanus, diphtheria and
acellular pertussis (Tdap);
zoster; and neumococcal.
E:\FR\FM\31JYP2.SGM
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The American Board
of Family Medicine
Centers for Medicare
& Medicaid Services
National Kidney
Foundation
National Committee
for Quality Assurance
EP31JY24.326
!
Person-Centered Primary
Care Measure Patient
Reported Outcome
Performance Measure
(PCPCM PRO-PM):
The Person-Centered
Primary Care Measure
Patient Reported Outcome
Performance Measure
(PCPCM PRO-PM) uses
the PCPCM Patient
Reported Outcome
Measure (PROM) a
comprehensive and
parsimonious set of 11
patient-reported items - to
assess the broad scope of
primary care. Unlike other
primary care measures, the
PCPCM PRO-PM
measures the high value
aspects of primary care
based on a patient's
relationship with the
clinician or practice.
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American Academy of
Hospice and Palliative
Medicine (AAHPM)
Centers for Medicare
and Medicaid Services
OCHTN
EP31JY24.327
!
(Outcome
)
PatientReported
OutcomeBased
Performance
Measure
Ambulatory Palliative
Care Patients' Experience
of Feeling Heard and
Understood:
The percentage of top-box
responses among patients
aged 18 years and older
who had an ambulatory
palliative care visit and
report feeling heard and
understood by their
palliative care clinician and
team within 2 months (60
days) of the ambulatory
alliative care visit.
Preventive Care and
Wellness (composite):
Percentage of patients who
received age- and sexappropriate preventive
screenings and wellness
services. This measure is a
composite of seven
component measures that
are based on
recommendations for
preventive care by the U.S.
Preventive Services Task
Force (USPSTF), ACTP,
American Association of
Clinical Endocrinology
(AACE), and American
College of Endocrinology
ACE.
Connection to
Community Service
Provider:
Percent of patients 18 years
or older who screen
positive for one or more of
the following health related
social needs (HRSNs): food
insecurity, housing
instability, transportation
needs, utility help needs, or
interpersonal safety; and
had contact with a
Community Service
Provider (CSP) for at least
1 of their HRSNs within 60
da s after screenin .
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American Psychiatric
Association
Insignia Health, LLC,
a wholly owned
subsidiary of Phreesia
American Psychiatric
Association
EP31JY24.328
!
(Outcome
)
PatientReported
OutcomeBased
Performance
Measure
Improvement or
Maintenance of
Functioning for
Individuals with a Mental
and/or Substance Use
Disorder:
The percentage of patients
aged 18 and older with a
mental and/or substance use
disorder who demonstrated
improvement or
maintenance of functioning
based on results from the
12-item World Health
Organization Disability
Assessment Schedule
(WHODAS 2.0) or
Sheehan Disability Scale
(SDS) 30 to 180 days after
an index assessment.
Gains in Patient
Activation Measure
(PAM®) Scores at 12
Months:
The Patient Activation
Measure® (PAM®) is a 10
- or 13 - item questionnaire
that assesses an individual· s
knowledge, skills and
confidence for managing
their health and health care.
The measure assesses
individuals on a 0-100 scale
that converts to one of four
levels of activation, from
low (I) to high (4). The
PAM® performance
measure (PAM®-PM) is
the change in score on the
PAM® from baseline to
follow-u measurement.
Initiation, Review,
And/Or Update To
Suicide Safety Plan For
Individuals With Suicidal
Thoughts, Behavior, Or
Suicide Risk: Percentage
ofadult aged 18 years and
older with suicidal ideation
or behavior symptoms
(based on results of a
standardized assessment
tool or screening tool) or
increased suicide risk
(based on the clinician's
evaluation or clinicianrating tool) for whom a
suicide safety plan is
initiated, reviewed, and/or
updated in collaboration
between the patient and
their clinician.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62373
B.19. Internal Medicine
Adult COVID-
95
96
TBD
NIA
Process
Centers
for
Medicare
&
Medicaid
Services
See footnote lkeokwu et al., 2023 in Table B.l of this Appendix.
See footnotes Fitzpatrick et al., 2022; Polack et al., 2020; and Grana et al., 2022 in Table A.5 of this Appendix.
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MIPS
CQM
Specificati
ons
19 Vaccination
Status:
Percentage of
patients aged 18
years and older
seen for a visit
during the
performance
period that are up
to date on their
COVID-19
vaccinations as
defined by CDC
recommendation
son current
vaccination.
We are proposing to include this
measure in the Internal Medicine
specialty set as it would be
clinically relevant to this clinician
type. Widespread vaccination
against SARS-CoV-2, the virus
that causes COVID-19, is
critically important to stemming
the morbidity and mortality
caused by this disease. 95
Clinicians are uniquely positioned
to encourage uptake ofCOVID19 vaccination, and clinicians are
still a major driving force in
promoting patient vaccination.
The addition of this quality
measure in this specialty set
would help strengthen compliance
with recommended COVID-19
vaccination, leading to
improvement in the quality of
patient care and prevention of
disease for the general population.
This quality measure aligns with
clinical guidelines and the
evidence-based recommendations
of the (ACIP, where there is
general agreement about the
safety and efficacy of the
COVTD-19 vaccine, preventing
costly and potentially harmful
hospitalizations. 96 Broadening
vaccination status awareness to
this clinician type is valuable as it
can help drive an increase in the
adult vaccination rates. The
COVID-19 vaccination included
within this measure would reduce
the prevalence of severe diseases
that may be associated with
hospitalization and decrease
overall health care costs. The
measure being added to this
specialty set would be contingent
on the inclusion of applicable
coding by the time of the CY
2025 PFS fmal rule. In the event
appropriate coding is not included
in the final specification, this
measure would not be fmalized
for inclusion within this specialty
measure set. See Table A.5 of this
Appendix for rationale, including
clinical evidence supporting the
inclusion of this measure in
MIPS.
62374
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8.19. Internal Medicine
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Services
E:\FR\FM\31JYP2.SGM
31JYP2
This measure is being
proposed for removal
beginning with the CY
2025 performance
periodl2027 MIPS
payment year. See Table
Group C for rationale.
EP31JY24.330
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3475e
Appropriate Use of DXA
Scans in Women Under 65
Years Who Do Not Meet
the Risk Factor Profile for
Osteoporotic Fracture:
Percentage of female
patients 50 to 64 years of
age without select risk
factors for osteoporotic
fracture who received an
order for a dual-energy xray absorptiometry (DXA)
scan during the
measurement eriod.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62375
B.20. lnterventional Radiology
In addition to the considerations discussed in the introductory language of Table Group B of this Appendix to this proposed rule,
the lnterventional Radiology specialty set takes additional criteria into consideration, which includes, but is not limited to:
whether a measure reflects current clinical guidelines, and the coding of the measure includes relevant clinician types. We may
reassess the appropriateness of individual measures, on a case-by-case basis, to ensure appropriate inclusion in the specialty set.
Measure tables in this set include previously finalized measures we are maintaining within the set, measures proposed to be
added, and measures proposed for removal, as applicable. We request comment on the measures available in the proposed
lnterventional Radiology specialty set.
B.20. lnterventional Radiology
(Patient
Safety)
*!
(Care
Coordinatio
n)
*!
(Outcome)
*!
(Outcome)
!
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(Patient
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NIAi
NIA
NIAi
NIA
NIAi
NIA
145
374
413
NIA
CMS
50v13
eCQM
Specificatio
ns, MIPS
CQM
Specificatio
ns
Process
NIA
MIPS
CQM
Specificatio
ns
Interrnedi
ate
Outcome
Radiology: Exposure Dose
Indices Reported for Procedures
Using Fluoroscopy:
Final reports for procedures using
fluoroscopy that document
radiation exposure indices.
Process
NIAi
NIA
420
NIA
MIPS
CQM
Specificatio
ns
PatientReported
OutcomeBased
Perforrnan
ce
Measure
NIAi
NIA
421
NIA
MIPS
CQM
Specificatio
ns
Process
NIAi
NIA
465
NIA
MIPS
CQM
Specificatio
ns
Process
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Closing the Referral Loop:
Receipt of Specialist Report:
Percentage of patients with
referrals, regardless of age, for
which the referring clinician
receives a report from the clinician
to whom the atient was referred.
Door to Puncture Time for
Endovascular Stroke Treatment:
Percentage of patients undergoing
endovascular stroke treatment who
have a door to puncture time of 90
minutes or less.
Varicose Vein Treatment with
Saphenous Ablation: Outcome
Survey:
Percentage of patients treated for
varicose veins (CEAP C2-S) who
are treated with saphenous ablation
(with or without adjunctive
tributary treatment) that report an
improvement on a disease specific
patient reported outcome survey
instrument after treatment.
Appropriate Assessment of
Retrievable Inferior Vena Cava
(IVC) Filters for Removal:
Percentage of patients in whom a
retrievable IVC filter is placed who,
within 3 months post-placement,
have a documented assessment for
the appropriateness of continued
filtration, device removal or the
inability to contact the patient with
at least two attem ts.
Uterine Artery Embolization
Technique: Documentation of
Angiographic Endpoints and
Interrogation of Ovarian
Arteries:
The percentage of patients with
documentation of angiographic
endpoints of embolization AND the
documentation of embolization
strategies in the presence of
unilateral or bilateral absent uterine
arteries.
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American College of
Radiology
Centers for Medicare &
Medicaid Services
Society of
Interventional
Radiology
Society of
lnterventional
Radiology
Society of
Interventional
Radiology
Society of
lnterventional
Radiology
EP31JY24.331
!
Medicare
Part B
Claims
Measure
Specificatio
ns, MIPS
CQM
Specificatio
ns
62376
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
8.20. lnterventional Radiology
!
(Equity)
*
!
(Equity)
NIAi
NIA
NIA
487
NIAi
NIA
NIA
498
MIPS
CQM
Specificatio
ns
MIPS
CQM
Specificatio
ns
Process
Process
Screening for Social Drivers of
Health:
Percent of patients 18 years and
older screened for food insecurity,
housing instability, transportation
needs, utility difficulties, and
inter ersonal safe! .
Connection to Community
Service Provider:
Percent of patients 18 years or older
who screen positive for one or more
of the following health related
social needs (HRSNs): food
insecurity, housing instability,
transportation needs, utility help
needs, or interpersonal safety; and
had contact with a Community
Service Provider ( CSP) for at least
1 of their HRSNs within 60 days
atler screenin .
Centers for Medicare &
Medicaid Services
OCHTN
8.20. lnterventional Radiology
NIA
MIPS CQM
Specification
Outcome
Centers for
Medicare &
Medicaid
Services
EP31JY24.333
409
This measure is being
proposed for removal
beginning with the CY
2025 performance
periodl2027 MIPS
payment year. See Table
Group C for rationale.
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Clinical Outcome Post
Endovascular Stroke
Treatment: Percentage of
patients with a Modified
Rankin Score (mRS) score
of0 to 2 at 90 days
following endovascular
stroke intervention.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62377
B.21. Mental/Behavioral Health and Psychiatry
In addition to the considerations discussed in the introductory language of Table Group B of this Appendix to this proposed rule,
the Mental/Behavioral Health and Psychiatry specialty set takes additional criteria into consideration, which includes, but is not
limited to: whether a measure reflects current clinical guidelines, and the coding of the measure includes relevant clinician types.
We may reassess the appropriateness of individual measures, on a case-by-case basis, to ensure appropriate inclusion in the
specialty set. Measure tables in this set include previously finalized measures we are maintaining within the set, measures
proposed to be added, and measures proposed for removal, as applicable. We request comment on measures available in the
proposed Mental/Behavioral Health and Psychiatry specialty set that have proposed substantive changes in Table Group D of this
Appendix as indicated by an * in the Indicator column.
B.21. Mental/Behavioral Health and Psychiatry
009
CMSl2
8vl3
eCQM
Specifications
Process
130
CMS68
v14
eCQM
Specifications,
MIPS CQM
Specifications
Process
CMS2v
14
Medicare Part
B Claims
Measure
Specifications,
eCQM
Specifications,
MIPS CQM
Specifications
Process
181
NIA
Medicare Part
B Claims
Measure
Specifications,
MIPS CQM
Specifications
Process
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*
§
!
(Patient
Safety)
NIAi
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§
*
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(Patient
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National Committee
for Quality Assurance
Centers for Medicare
& Medicaid Services
Centers for Medicare
& Medicaid Services
Centers for Medicare
& Medicaid Services
EP31JY24.334
NIAi
NIA
*
Antidepressant Medication
Management:
Percentage of patients 18 years of
age and older who were treated
with antidepressant medication,
had a diagnosis of major
depression, and who remained on
an antidepressant medication
treatment. Two rates are reported.
a. Percentage of patients who
remained on an antidepressant
medication for at least 84 days
(12 weeks).
b. Percentage of patients who
remained on an antidepressant
medication for at least 180 days
6 months .
Documentation of Current
Medications in the Medical
Record:
Percentage of visits for patients
aged 18 years and older for which
the eligible clinician attests to
documenting a Iist of current
medications using all immediate
resources available on the date of
the encounter.
Preventive Care and Screening:
Screening for Depression and
Follow-Up Plan:
Percentage of patients aged 12
years and older screened for
depression on the date of the
encounter or up to 14 days prior
to the date of the encounter using
an age-appropriate standardized
depression screening tool AND if
positive, a follow-up plan is
documented on the date of or up
to two days after the date of the
uali in encounter.
Elder Maltreatment Screen and
Follow-Up Plan:
Percentage of patients aged 60
years and older with a
documented elder maltreatment
screen using an Elder
Maltreatment Screening tool on
the date of encounter AND a
documented follow-up plan on the
date of the ositive screen.
62378
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
B.21. Mental/Behavioral Health and Psychiatry
*
*
*
!
(Patient
Safety)
*
!
(Care
Coordinatio
NIAi
NIA
226
CMSl3
8vl3
NIAi
2872e
281
CMS14
9v13
eCQM
Specifications
Process
NIAi
NIA
282
NIA
MIPS CQM
Specifications
Process
NIA
MIPS CQM
Specifications
288
NIA
MIPS CQM
Specifications
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n)
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National Committee
for Quality Assurance
American Academy of
Neurology
American Academy of
Neurology/ American
Psychiatric
Association
American Psychiatric
Association/ American
Academy of
Neurology
American Academy of
Neurology/ American
Psychiatric
Association
EP31JY24.335
§
Medicare Part
B Claims
Measure
Specifications,
eCQM
Specifications,
MIPS CQM
Specifications
Preventive Care and Screening:
Tobacco Use: Screening and
Cessation Intervention:
Percentage of patients aged 12
years and older who were
screened for tobacco use one or
more times during the
measurement period AND who
received tobacco cessation
intervention during the
measurement period or in the six
months prior to the measurement
period if identified as a tobacco
user.
Dementia: Cognitive
Assessment:
Percentage of patients, regardless
of age, with a diagnosis of
dementia for whom an assessment
of cognition is performed and the
results reviewed at least once
within a 12-month eriod.
Dementia: Functional Status
Assessment:
Percentage of patients with
dementia for whom an assessment
of functional status was
performed at least once in the last
12 months.
Dementia: Safety Concern
Screening and Follow-Up for
Patients with Dementia:
Percentage of patients with
dementia or their caregiver(s) for
whom there was a documented
safety concerns screening in two
domains of risk: (1)
dangerousness to self or others
and (2) environmental risks; and
if safety concerns screening was
positive in the last 12 months,
there was documentation of
mitigation recommendations,
including but not limited to
referral to other resources.
Dementia: Education and
Support of Caregivers for
Patients with Dementia:
Percentage of patients with
dementia whose caregiver(s) were
provided with education on
dementia disease management
and health behavior changes AND
were referred to additional
resources for support in the last
12 months.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62379
8.21. Mental/Behavioral Health and Psychiatry
*
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CMSl3
7v13
eCQM
Specifications
NIAi
NIA
317
CMS22
v13
Medicare Part
B Claims
Measure
Specifications,
eCQM
Specifications,
MIPS CQM
Specifications
NIAi
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Specifications
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Preventive Care and Screening:
Screening for High Blood
Pressure and Follow-Up
Documented:
Percentage of patient visits for
patients aged 18 years and older
seen during the measurement
period who were screened for
high blood pressure AND a
recommended follow-up plan is
documented, as indicated, if blood
pressure is elevated or
h ertensive.
Follow-Up Care for Children
Prescribed ADHD Medication
(ADD):
Percentage of children 6-12 years
of age and newly prescribed a
medication for attentiondeficit/hyperactivity disorder
(ADHD) who had appropriate
follow-up care. Two rates are
reported.
(a) Percentage of children who
had one follow-up visit with a
practitioner with prescribing
authority during the 30-Day
Initiation Phase.
(b) Percentage of children who
remained on ADHD medication
for at least 210 days and who, in
addition to the visit in the
Initiation Phase, had at least two
additional follow-up visits with a
practitioner within 270 days (9
months) after the Initiation Phase
ended.
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National Committee
for Quality Assurance
Centers for Medicare
and Medicaid Services
National Committee
for Quality Assurance
EP31JY24.336
!
(Opioid)
Initiation and Engagement of
Substance Use Disorder
Treatment:
Percentage of patients 13 years of
age and older with a new
substance use disorder (SUD)
episode who received the
following (Two rates are
reported):
a. Percentage of patients who
initiated treatment, including
either an intervention or
medication for the treatment of
SUD, within 14 days of the new
SUD episode.
b. Percentage of patients who
engaged in ongoing treatment,
including two additional
interventions or medication
treatment events for SUD, or one
long-acting medication event for
the treatment of SUD, within 34
days of the initiation.
62380
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
B.21. Mental/Behavioral Health and Psychiatry
·,., · PREVIOlJSL \' FINALIZED MEASURES lNTHE MENTAUBEI.IAVJORAL :HEALTHAND l?SYClUATRY SPECIALTY SET
.
.....
··.·.·.·CMS
i
Measut
CBE#/
Collection
•
Meai,11re
Title
,.
..
.•.•
Quality
••·
.C.
Q.
•
•.M·
Measure
Steward
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.
e
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.'
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370
eCQM
Specifications,
MIPS CQM
Specifications
Outcome
NIAi
NIA
382
CMS17
7vl3
eCQM
Specifications
Process
18791
NIA
383
NIA
MIPS CQM
Specifications
Intermed
iate
Outcome
2152 I
NIA
431
NIA
MIPS CQM
Specifications
Process
NIAi
NIA
468
NIA
MIPS CQM
Specifications
Process
NIAi
NIA
487
NIA
MIPS CQM
Specifications
Process
Jkt 262001
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!
(Patient
Safety)
*
§
!
(Outcome)
§
!
(Opioid)
!
(Equity)
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0710 I
0710e
§
!
(Outcome)
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Depression Remission at Twelve
Months:
The percentage of adolescent
patients 12 to 17 years of age and
adult patients 18 years of age or
older with major depression or
dysthymia who reached remission
12 months (+I- 60 days) after an
index event date.
Child and Adolescent Major
Depressive Disorder (MOD):
Suicide Risk Assessment:
Percentage of patient visits for
those patients aged 6 through 16
years at the start of the
measurement period with a
diagnosis of major depressive
disorder (MDD) with an
assessment for suicide risk.
Adherence to Antipsychotic
Medications for Individuals
with Schizophrenia:
Percentage of individuals at least
18 years of age as of the
beginning of the performance
period with schizophrenia or
schizoaffective disorder who had
at least two prescriptions filled for
any antipsychotic medication and
who had a Proportion of Days
Covered (PDC) of at least 0.8 for
antipsychotic medications during
the performance period.
Preventive Care and Screening:
Unhealthy Alcohol Use:
Screening & Brief Counseling:
Percentage of patients aged 18
years and older who were screened
for unhealthy alcohol use using a
systematic screening method at
least once within the last 12 months
AND who received brief
counseling if identified as an
unhealthy alcohol user.
Continuity of Pharmacotherapy
for Opioid Use Disorder (OUD):
Percentage of adults aged 18 years
and older with pharmacotherapy for
opioid use disorder (OUD) who
have at least 180 days of
continuous treatment.
Screening for Social Drivers of
Health:
Percent of patients 18 years and
older screened for food insecurity,
housing instability, transportation
needs, utility difficulties, and
interpersonal safetv.
Sfmt 4725
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31JYP2
..•.
Minnesota Community
Measurement
Mathematica
Centers for Medicare
& Medicaid Services
National Committee
for Qua] ity Assurance
University of Southern
California
Centers for Medicare
& Medicaid Services
EP31JY24.337
•,·
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62381
B.21. Mental/Behavioral Health and Psychiatry
*
!
(Equity)
!
(Outcome)
!
(Safety)
*
498
NIA
NIAi
NIA
502
NIA
MIPS CQM
Specifications
NIAi
NIA
504
NIA
MIPS CQM
Specifications
NIAi
NIA
505
NIA
MIPS CQM
Specifications
OCHIN
American Psychiatric
Association
American Psychiatric
Association
American Psychiatric
Association
B.22. Nephrology
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(Outcome)
MIPS CQM
Specifications
NIAi
NIA
Connection to Community
Service Provider:
Percent of patients 18 years or
older who screen positive for one
or more of the following health
related social needs (HRSNs):
food insecurity, housing
Process
instability, transportation needs,
utility help needs, or interpersonal
safety; and had contact with a
Community Service Provider
(CSP) for at least 1 of their
HRSNs within 60 days after
screenin .
Improvement or Maintenance
of Functioning for Individuals
with a Mental and/or Substance
Use Disorder:
PatientThe percentage of patients aged
18 and older with a mental and/or
Reported
Outcome- substance use disorder who
Based
demonstrated improvement or
Performan maintenance of functioning based
ce
on results from the 12-item World
Measure
Health Organization Disability
Assessment Schedule (WHODAS
2.0) or Sheehan Disability Scale
(SDS) 30 to 180 days after an
index assessment.
Initiation, Review, And/Or
Update To Suicide Safety Plan
For Individuals With Suicidal
Thoughts, Behavior, Or Suicide
Risk:
Percentage of adult aged 18 years
and older with suicidal ideation or
behavior symptoms (based on
Process
results of a standardized
assessment tool or screening tool)
or increased suicide risk (based on
the clinician's evaluation or
clinician-rating tool) for whom a
suicide safety plan is initiated,
reviewed, and/or updated in
collaboration between the patient
and their clinician.
Reduction in Suicidal Ideation
or Behavior Symptoms:
The percentage of patients aged
18 and older with a mental and/or
Patientsubstance use disorder AND
Reported
suicidal thoughts. behaviors or
Outcomerisk symptoms who demonstrated
Based
a reduction in suicidal ideation
Performan
and/or behavior symptoms based
ce
on results from the ColumbiaMeasure
Suicide Severity Rating Scale (CSSRS) ·screen Version' or •Since
Last Visit' within 120 days after
an index assessment.
62382
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
In addition to the considerations discussed in the introductory language of Table Group B of this Appendix to this proposed rule,
the Nephrology specialty set takes additional criteria into consideration, which includes, but is not limited to: whether a measure
reflects current clinical guidelines, and the coding of the measure includes relevant clinician types. We may reassess the
appropriateness of individual measures, on a case-by-case basis, to ensure appropriate inclusion in the specialty set. Measure
tables in this set include previously finalized measures we are maintaining within the set, measures proposed to be added, and
measures proposed for removal, as applicable. We request comment on the measures available in the proposed Nephrology
specialty set.
B.22. Nephrology
PREVJOUSLY FINALIZED MEASURES IN THE NEPHROLOGY SPECIALTY SET
Quality
#
CBE#
CMS
eCQM
ID
·•·
!
(Outcome)
*
!
(Care
Coordination
0059 I
NIA
001
CMS12
2v13
Intermediate
Outcome
Process
0326 I
NIA
047
NIA
Medicare Part
B Claims
Measure
Specifications,
MIPS CQM
Specifications
NIAi
NIA
130
CMS68
v14
eCQM
Specifications,
MIPS CQM
Specifications
Process
NIAi
NIA
182
NIA
MIPS CQM
Specifications
Process
)
*
§
!
(Patient
Safety)
*
§
!
(Care
Coordination
Measure
Type
Medicare Part
B Claims
Measure
Specifications,
eCQM
Specifications,
MIPS CQM
Specifications
*
§
Collection
Type
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)
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Measure Title
and Oescrjption
Diabetes: Hemoglobin Ale
(HbAlc) Poor Control
(>9%):
Percentage of patients 18-75
years of age with diabetes who
had hemoglobin Ale> 9.0%
during the measurement
period.
Advance Care Plan:
Percentage of patients aged 65
years and older who have an
advance care plan or surrogate
decision maker documented in
the medical record or
documentation in the medical
record that an advance care
plan was discussed but the
patient did not wish or was not
able to name a surrogate
decision maker or provide an
advance care plan.
Documentation of Current
Medications in the Medical
Record:
Percentage of visits for patients
aged 18 years and older for
which the eligible clinician
attests to documenting a list of
current medications using all
immediate resources available
on the date of the encounter.
Functional Outcome
Assessment:
Percentage of visits for patients
aged 18 years and older with
documentation of a current
functional outcome assessment
using a standardized functional
outcome assessment tool on the
date of the encounter AND
documentation of a care plan
based on identified functional
outcome deficiencies within
two days of the date of the
identified deficiencies.
E:\FR\FM\31JYP2.SGM
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Measure Steward
National Committee
for Quality
Assurance
National Committee
for Quality
Assurance
Centers for Medicare
& Medicaid Services
Centers for Medicare
& Medicaid Services
EP31JY24.339
Indicator
t:BE#
1
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National Committee
for Quality
Assurance
Centers for Medicare
& Medicaid Services
National Committee
for Quality
Assurance
American
Gastroenterological
Association
Centers for Medicare
& Medicaid Services
Centers for Medicare
& Medicaid Services
EP31JY24.340
Medicare Part
B Claims
Preventive Care and
Screening: Tobacco llse:
Screening and Cessation
Intervention:
Percentage of patients aged 12
years and older who were
screened for tobacco use one or
more times during the
measurement period AND who
received tobacco cessation
intervention during the
measurement period or in the
six months prior to the
measurement period if
identified as a tobacco user.
Preventive Care and
Screening: Screening for
High Blood Pressure and
Follow-Up Documented:
Percentage of patient visits for
patients aged 18 years and
older seen during the
measurement period who were
screened for high blood
pressure AND a recommended
follow-up plan is documented,
as indicated, if blood pressure
is elevated or h ertensive.
Falls: Screening for Future
Fall Risk:
Percentage of patients 65 years
of age and older who were
screened for future fall risk
during the measurement
eriod.
One-Time Screening for
Hepatitis C Virus (HCV) and
Treatment Initiation:
Percentage of patients age >=
18 years have never been tested
for Hepatitis C Virus (HCV)
infection who receive an HCV
infection test AND who have
treatment initiated within three
months or who are referred to a
clinician who treats HCV
infection within one month if
tested ositive for HCV.
Hemodialysis Vascular
Access: Practitioner Level
Long-term Catheter Rate:
Percentage of adult
hemodialysis (HD) patientmonths using a catheter
continuously for three months
or longer for vascular access
attributable to an individual
ractitioner or rou ractice.
Screening for Social Drivers
of Health:
Percent of patients 18 years
and older screened for food
insecurity, housing instability,
transportation needs, utility
difficulties, and interpersonal
safe!
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National Kidney
Foundation
Renal Physicians
Association
National Committee
for Quality
Assurance
OCHIN
EP31JY24.341
*
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Kidney Health Evaluation:
Percentage of patients aged 1875 years with a diagnosis of
diabetes who received a kidney
health evaluation defined by an
Estimated Glomerular
Filtration Rate (eGFR) AND
Urine Albumin-Creatinine
Ratio (uACR) within the
measurement eriod.
Adult Kidney Disease:
Angiotensin Converting
Enzyme (ACE) Inhibitor or
Angiotensin Receptor
Blocker (ARB) Therapy:
Percentage of patients aged 18
years and older with a
diagnosis of chronic kidney
disease (CKD) (Stages 1-5, not
receiving Renal Replacement
Therapy (RRT)) and
proteinuria who were
prescribed ACE inhibitor or
ARB therapy within a 12month eriod.
Adult Immunization Status:
Percentage of patients 19 years
of age and older who are up-todate on recommended routine
vaccines for influenza; tetanus
and diphtheria (Td) or tetanus,
diphtheria and acellular
pertussis (Tdap); zoster; and
neumococcal.
Connection to Community
Service Provider:
Percent of patients 18 years or
older who screen positive for
one or more of the following
health related social needs
(HRSNs): food insecurity,
housing instability,
transportation needs, utility
help needs, or interpersonal
safety; and had contact with a
Community Service Provider
(CSP) for at least I of their
HRSNs within 60 days after
screenin .
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Type
Measqre
Type
Measure Title
and Description
MIPS CQM
Specifications
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Measure Steward
.·
·.
PatientReported
OutcomeBased
Performanc
e Measure
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Gains in Patient Activation
Measure (PAM®) Scores at
12 Months:
The Patient Activation
Measure® (PAM®) is a 10or 13 - item questionnaire that
assesses an individual's
knowledge, skills and
confidence for managing their
health and health care. The
measure assesses individuals
on a 0-100 scale that converts
to one of four levels of
activation, from low (I) to high
(4). The PAM® performance
measure (PAM®-PM) is the
change in score on the PAM®
from baseline to follow-up
measurement
E:\FR\FM\31JYP2.SGM
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Insignia Health,
LLC, a wholly
owned subsidiary of
Phreesia
EP31JY24.342
CBE#.
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8.22. Nephrology
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)
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98
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CQM
Specificati
ons
PatientReported
OutcomeBased
Performanc
e Measure
American
Academy
of Hospice
and
Palliative
Medicine
(AAHPM)
Process
Adult COVID19 Vaccination
Status:
Percentage of
patients aged 18
years and older
seen for a visit
Centers for
Medicare
&
Medicaid
Services
See footnote Kilic et al., 2020 in Table B.4a of this Appendix.
See footnote National Consensus Project for Quality Palliative Care, 2018 in Table B.4a of this Appendix.
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MIPS
CQM
Specificati
ons
Ambulatory
Palliative Care
Patients'
Experience of
Feeling Heard
and
Understood:
The percentage
of top-box
responses among
patients aged 18
years and older
who had an
ambulatory
palliative care
visit and report
feeling heard and
understood by
their palliative
care clinician and
team within 2
months (60 days)
ofthe
ambulatory
palliative care
visit.
We are proposing to include this
measure in the Nephrology
specialty set as it would be
clinically relevant to this
clinician type. This PRO-PM
would help to fill a gap for
patients receiving palliative care
by capturing the patient's voice
and experience of care by
assessing communication and
shared decision making with the
clinician. This is an important
patient-centered measure that
helps patients feel heard and
understood which can
effectively improve the quality
of care received and outcomes
for patients in palliative care.
Allowing patients to feel heard
and understood adds an
important dimension to the care
planning for this unique patient
population commonly cared for
by clinicians in this specialty. As
more patients are living longer
with multiple comorbidities,
especially true for the advanced
heart disease patient population,
early emergence of palliative
care into the overall care of
cardiac patients can notably
improve their quality of life,
patient satisfaction, and
reduction in symptoms. 97 This
measure is predicated on
existing guidelines and
conceptual models98 and can
facilitate and improve effective
patient-clinician communication
that engenders trust,
acknowledgement, and a wholeperson orientation to the care
that is provided. Through the
benefits of enhanced patientprovider communication, this
measure would improve the
quality of care received and
outcomes for patients receiving
palliative care. The measure
being added to this specialty set
would be contingent on the
inclusion of applicable coding
by the time of the CY 2025 PFS
fmalrule.
We are proposing to include this
measure in the Nephrology
specialty set as it would be
clinically relevant to this
clinician type. Widespread
vaccination against SARS-CoV2, the virus that causes COVID-
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62387
8.22. Nephrology
99
19, is critically important to
stemming the morbidity and
mortality caused by this
disease. 99 Clinicians are
uniquely positioned to
encourage uptake ofCOVTD-19
vaccination, and clinicians are
still a major driving force in
promoting patient vaccination.
The addition of this quality
measure in this specialty set
would help strengthen
compliance with recommended
COVTD-19 vaccination, leading
to improvement in the quality of
patient care and prevention of
disease for the general
population. This quality measure
aligns with clinical guidelines
and the evidence-based
recommendations of the ACTP,
where there is general agreement
about the safety and efficacy of
the COVTD-19 vaccine,
preventing costly and potentially
harmful hospitalizations. 100
Broadening vaccination status
awareness to this clinician type
is valuable as it can help drive
an increase in the adult
vaccination rates. The COVID19 vaccination included within
this measure would reduce the
prevalence of severe diseases
that may be associated with
hospitalization and decrease
overall health care costs. The
measure being added to this
specialty set would be
contingent on the inclusion of
applicable coding by the time of
the CY 2025 PFS final rule. In
the event appropriate coding is
not included in the final
specification, this measure
would not be finalized for
inclusion within this specialty
measure set. See Table A.5 of
this Appendix for rationale,
including clinical evidence
supporting the inclusion of this
measure in MIPS.
See footnote lkeokwu et al., 2023 in Table B.l of this Appendix.
See footnotes Fitzpatrick et al., 2022; Polack et al., 2020; and Grana et al., 2022 in Table A.5 of this Appendix.
100
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during the
performance
period that are up
to date on their
COVID-19
vaccinations as
defined by CDC
recommendation
son current
vaccination.
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Medicaid
Services
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We are proposing to include this
measure in the Nephrology
specialty set as it would be
clinically relevant to this
clinician type. The measure's
intended objective consists of
improving the overall health of
patients on dialysis, with
nephrologists at the forefront of
caring for this patient
population. Clinicians within
this specialty are responsible for
the education of patients about
the option of transplantation,
referral of patients to a
transplant center for evaluation,
completion of the evaluation
process, and optimizing the
health of the patient while on
dialysis. All clinicians should be
involved and actively work
towards providing patients with
high quality care including
ensuring placement on the
transplant list as quickly as
possible. The measure being
added to this specialty set would
be contingent on the inclusion of
applicable coding by the time of
the CY 2025 PFS final rule. See
Table A.7 of this Appendix for
rationale, including clinical
evidence supporting the
inclusion of this measure in
MIPS.
31JYP2
EP31JY24.345
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MIPS
CQM
Specificati
ons
First Year
Standardized
Waitlist Ratio
(FYSWR):
The number of
incident (newly
initiated on
dialysis) patients
in a practitioner
(inclusive of
physicians and
advanced
practice
providers) group
who are under
the age of75,
and were listed
on the kidney or
kidney-pancreas
transplant
waitlistor
received a living
donor transplant
within the first
year of initiating
dialysis. The
measure 1s
calculated to
compare the
observed number
of waitlist events
in a practitioner
group to its
expected number
ofwaitlist events.
The measure
uses the expected
waitlist events
calculated from a
Cox model,
adjusted for age,
patient
comorbidities,
and other risk
factors at
incidence of
dial sis.
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We are proposing to include this
measure in the Nephrology
specialty set as would be
clinically relevant to this
clinician type. The maintenance
of end stage renal disease
patients on active status on the
waitlist is additionally important
given demonstrated disparities
and positive association with
subsequent transplantation.
These practices are important for
nephrologists who are at the
forefront of caring for this
patient population. This is an
important area to which dialysis
practitioners can contribute
through ensuring patients remain
healthy and complete any
ongoing testing activities
required to remain active on the
waitlist. The measure being
added to this specialty set would
be contingent on the inclusion of
applicable coding by the time of
the CY 2025 PFS final rule. See
Table A.8 of this Appendix for
rationale, including clinical
evidence supporting the
inclusion of this measure in
MIPS.
31JYP2
EP31JY24.346
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Percentage of
Prevalent
Patients
Waitlisted
(PPPW)and
Percentage of
Prevalent
Patients
Waitlisted in
Active Status
(aPPPW):
The percentage
of patients in
each dialysis
practitioner
group practice
who were on the
kidney or
kidney-pancreas
transplant
waitlist (all
patients or
patients in active
status). Results
are averaged
across patients
prevalent on the
last day of each
month during the
reporting year.
The measure is a
directly
standardized
percentage,
which is adjusted
for covariates
(e.g., age and
risk factors).
62390
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B.23. Neurology
In addition to the considerations discussed in the introductory language of Table Group B of this Appendix to this proposed rule,
the Neurology specialty set takes additional criteria into consideration, which includes, but is not limited to: whether a measure
reflects current clinical guidelines, and the coding of the measure includes relevant clinician types. We may reassess the
appropriateness of individual measures, on a case-by-case basis, to ensure appropriate inclusion in the specialty set. Measure
tables in this set include previously finalized measures we are maintaining within the set, measures proposed to be added, and
measures proposed for removal, as applicable. We request comment on the measures available in the proposed Neurology
specialty set that have proposed substantive changes in Table Group D of this Appendix as indicated by an* in the Indicator
column.
8.23. Neurology
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B Claims
Measure
Specifications,
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BClaims
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Specifications
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National
Committee for
Quality Assurance
Centers for
Medicare &
Medicaid Services
Centers for
Medicare &
Medicaid Services
National
Committee for
Quality Assurance
Centers for
Medicare &
Medicaid Services
EP31JY24.347
047
Medicare Part
BClaims
Measure
Specifications,
MIPSCQM
Specifications
*
Advance Care Plan:
Percentage of patients aged 65
years and older who have an
advance care plan or surrogate
decision maker documented in
the medical record or
documentation in the medical
record that an advance care plan
was discussed but the patient did
not wish or was not able to name
a surrogate decision maker or
rovide an advance care Ian.
Documentation of Current
Medications in the Medical
Record:
Percentage of visits for patients
aged 18 years and older for
which the eligible clinician
attests to documenting a list of
current medications using all
immediate resources available on
the date of the encounter.
Preventive Care and
Screening: Screening for
Depression aud Follow-Up
Plan:
Percentage of patients aged 12
years and older screened for
depression on the date of the
encow1ter or up to 14 days prior
to the date of the encounter using
an age-appropriate standardized
depression screening tool AND if
positive, a follow-up plan is
documented on the date of or up
to two days after the date of the
ualir in encounter.
Falls: Plan of Care:
Percentage of patients aged 65
years and older with a history of
falls who had a plan of care for
falls documented within 12
months.
Elder Maltreatment Screen
and Follow-Up Plan:
Percentage of patients aged 60
years and older with a
documented elder maltreatment
screen using an Elder
Maltreatment Screening tool on
the date of encounter AND a
documented follow-up plan on
the date of the ositive screen.
62391
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.···•
,·,
.
•,
·indicator
.•..
i
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·. Type
•.. • •··
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.
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B Claims
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Specifications,
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Specifications,
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Specifications
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•
Process
Sfmt 4725
..•.
·,•
•
... ·
..
i
•,
Measure•Steward
....·
,·
Preventive Care and
Screening: Tobacco Use:
Screening and Cessation
Intervention:
Percentage of patients aged 12
years and older who were
screened for tobacco use one or
more times during the
measurement period AND who
received tobacco cessation
intervention during the
measurement period or in the six
months prior to the measurement
period if identified as a tobacco
user.
Epilepsy: Counseling for
Women of Childbearing
Potential with Epilepsy:
Percentage of all patients of
childbearing potential ( 12 years
and older) diagnosed with
epilepsy who were counseled at
least once a year about how
epilepsy and its treatment may
affect contraception and
oregnancv.
Sleep Apnea: Severity
Assessment at Initial Diagnosis:
Percentage of patients aged 18
years and older with a diagnosis
of obstructive sleep apnea who
had an apnea hypopnea index
(AHT), a respiratory disturbance
index (RDI), or a respiratory
event index (REI) documented or
measured within 2 months of
initial evaluation for suspected
obstructive sleep apnea.
Sleep Apnea: Assessment of
Adherence to Obstructive Sleep
Apnea (OSA) Therapy:
Percentage of patients aged 18
years and older with a diagnosis
of obstructive sleep apnea (OSA)
that were prescribed an evidencebased therapy that had
documentation that adherence to
therapy was assessed at least
annually through an objective
informatics system or through
self-reporting (if objective
reporting is not available).
Dementia: Cognitive
Assessment:
Percentage of patients, regardless
of age, with a diagnosis of
dementia for whom an
assessment of cognition is
performed and the results
reviewed at least once within a
12-month period.
E:\FR\FM\31JYP2.SGM
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\
31JYP2
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National
Committee for
Quality Assurance
American
Academy of
Neurology
American
Academy of Sleep
Medicine
American
Academy of Sleep
Medicine
American
Academy of
Neurology
EP31JY24.348
•.•·
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American
Academy of
Neurology/
American
Psychiatric
Association
American
Psychiatric
Association/
American
Academy of
Neurology
American
Academy of
Neurology/
American
Psychiatric
Association
American
Academy of
Neurology
American
Academy of
Neurology
American
Academy of
Neurology
EP31JY24.349
*
Dementia: Functional Status
Assessment:
Percentage of patients with
dementia for whom an
assessment of functional status
was performed at least once in
the last 12 months.
Dementia: Safety Concern
Screening and Follow-lip for
Patients with Dementia:
Percentage of patients with
dementia or their caregiver(s) for
whom there was a documented
safety concerns screening in two
domains of risk: ( 1)
dangerousness to self or others
and (2) environmental risks; and
if safety concerns screening was
positive in the last 12 months,
there was documentation of
mitigation recommendations,
including but not limited to
referral to other resources.
Dementia: Education and
Support of Caregivers for
Patients with Dementia:
Percentage of patients with
dementia whose caregiver(s)
were provided with education on
dementia disease management
and health behavior changes
AND were referred to additional
resources for support in the last
12 months.
Assessment of Mood Disorders
and Psychosis for Patients with
Parkinson's Disease:
Percentage of all patients with a
diagnosis of Parkinson's Disease
(PD) who were assessed for
depression, anxiety, apathy, AND
psychosis once during the
measurement eriod.
Assessment of Cognitive
Impairment or Dysfunction for
Patients with Parkinson's
Disease:
Percentage of all patients with a
diagnosis of Parkinson's Disease
(PD) who were assessed for
cognitive impairment or
dysfunction once during the
measurement eriod.
Rehabilitative Therapy
Referral for Patients with
Parkinson's Disease:
Percentage of all patients with a
diagnosis of Parkinson's Disease
(PD) who were referred to
physical, occupational, speech, or
recreational therapy once during
the measurement eriod.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62393
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317
CMS22
vl3
NIAi
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CMS50
vl3
eCQM
Specifications,
MIPSCQM
Specifications
Process
NIAi
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386
NIA
MIPSCQM
Specifications
Process
NIAi
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419
NIA
MIPSCQM
Specifications
Process
§
21521
NIA
431
NIA
MIPSCQM
Specifications
Process
!
(Equity)
NIAi
NIA
487
NIA
MTPSCQM
Specifications
Process
*
*
!
(Care
Coordination)
Process
*
!
(Patient
Experience)
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Centers for
Medicare and
Medicaid Services
Centers for
Medicare&
Medicaid Services
American
Academy of
Neurology
American
Academy of
Neurology
National
Committee for
Quality Assurance
Centers for
Medicare&
Medicaid Services
EP31JY24.350
NIAi
NIA
Medicare Part
BClaims
Measure
Specifications,
eCQM
Specifications,
MIPSCQM
Specifications
Preventive Care and
Screening: Screening for High
Blood Pressure and Follow-Up
Documented:
Percentage of patient visits for
patients aged 18 years and older
seen during the measurement
period who were screened for
high blood pressure AND a
recommended follow-up plan is
documented, as indicated, if
blood pressure is elevated or
h ertensive.
Closing the Referral Loop:
Receipt of Specialist Report:
Percentage of patients with
referrals, regardless of age, for
which the referring clinician
receives a report from the
clinician to whom the patient was
referred.
Amyotrophic Lateral Sclerosis
(ALS) Patient Care
Preferences:
Percentage of patients diagnosed
with Amyotrophic Lateral
Sclerosis (ALS) who were
offered assistance in planning for
end oflife issues (e.g., advance
directives, invasive ventilation,
lawful physician-hastened death,
or hospice) or whose existing end
oflife plan was reviewed or
updated at least once annually or
more frequency as clinically
indicated i.e. ra id ro ession.
Overuse oflmaging for the
Evaluation of Primary
Headache:
Percentage of patients for whom
imaging of the head (CT or MRI)
is obtained for the evaluation of
primary headache when clinical
indications are not
sent.
Preventive Care and
Screening: Unhealthy Alcohol
Use: Screening & Brief
Counseling:
Percentage of patients aged 18
years and older who were
screened for unhealthy alcohol
use using a systematic screening
method at least once within the
last 12 months AND who
received brief counseling if
identified as an unhealthy alcohol
user.
Screening for Social Drivers of
Health:
Percent of patients 18 years and
older screened for food
insecurity, housing instability,
transportation needs, utility
difficulties, and interpersonal
safe
62394
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B.23. Neurology
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(Equity)
*
!
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Specifications
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PatientReported
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ce
Measure
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OCHIN
Insignia Health,
LLC, a wholly
owned subsidiary
of Phreesia
EP31JY24.351
*
Connection to Community
Service Provider:
Percent of patients 18 years or
older who screen positive for one
or more of the following health
related social needs (HRSNs):
food insecurity, housing
instability, transportation needs,
utility help needs, or
interpersonal safety; and had
contact with a Community
Service Provider (CSP) for at
least 1 of their HRSNs within 60
da s atler screenin .
Gains in Patient Activation
Measure (PAM®) Scores at 12
Months:
The Patient Activation Measure®
(PAM®)isa 10-or 13-item
questionnaire that assesses an
individual's knowledge, skills
and confidence for managing
their health and health care. The
measure assesses individuals on a
0-100 scale that converts to one
of four levels of activation, from
low (1) to high (4). The PAM®
performance measure (PAM®PM) is the change in score on the
PAM® from baseline to followu measurement.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62395
B.24. Neurosurgical
In addition to the considerations discussed in the introductory language of Table Group B of this Appendix to this proposed rule,
the Neurosurgical specialty set takes additional criteria into consideration, which includes, but is not limited to: whether a
measure reflects current clinical guidelines, and the coding of the measure includes relevant clinician types. We may reassess the
appropriateness of individual measures, on a case-by-case basis, to ensure appropriate inclusion in the specialty set. Measure
tables in this set include previously finalized measures we are maintaining within the set, measures proposed to be added, and
measures proposed for removal, as applicable. We request comment on the measures available in the proposed Neurosurgical
specialty set.
B.24. Neurosurgical
§
§
NIAi
NIA
130
CMS68
vl4
eCQM
Specifications,
MIPSCQM
Specifications
Process
NIAi
NIA
187
NIA
MlPSCQM
Specifications
Process
Process
NIAi
NIA
226
CMS13
8v13
Medicare Part
BClaims
Measure
Specifications,
eCQM
Specifications,
MlPSCQM
Specifications
NIAi
NIA
344
NIA
MIPSCQM
Specifications
Outcome
NIAi
NIA
413
NIA
MlPSCQM
Specifications
lnterrnediat
eOutcome
*
!
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!
(Outcome)
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Centers for Medicare
& Medicaid Services
American Heart
Association
National Committee
for Quality Assurance
Society for Vascular
Surgeons
Society of
lnterventional
Radiology
EP31JY24.352
*
§
!
(Patient
Safety)
Documentation ofCnrrent
Medications in the Medical
Record:
Percentage of visits for patients
aged l 8 years and older for
which the eligible clinician
attests to documenting a list of
current medications using all
immediate resources available
on the date of the encounter.
Stroke and Stroke
Rehabilitation:
Thrombolytic Therapy:
Percentage of patients aged 18
years and older with a
diagnosis of acute ischemic
stroke who arrive at the
hospital within 3 .5 hours of
time last known well and for
whom IV thrombolytic therapy
was initiated within 4.5 hours
of time last known well.
Preventive Care and
Screening: Tobacco Use:
Screening and Cessation
Intervention:
Percentage of patients aged 12
years and older who were
screened for tobacco use one or
more times during the
measurement period AND who
received tobacco cessation
intervention during the
measurement period or in the
six months prior to the
measurement period if
identified as a tobacco user.
Rate of Carotid Artery
Stenting (CAS) for
Asymptomatic Patients,
Without Major
Complications (Discharged to
Home by Post-Operative Day
#2):
Percent of asymptomatic
patients undergoing CAS who
are discharged to home no later
than ost-o erative da #2.
Door to Puncture Time for
Endovascular Stroke
Treatment:
Percentage of patients
undergoing endovascular stroke
treatment who have a door to
puncture time of90 minutes or
less.
62396
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B.24. Neurosurgical
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§
!
(Outcome)
§
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Performan
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Specifications
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OutcomeBased
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Minnesota
Community
Measurement
Minnesota
Community
Measurement
Minnesota
Commnnity
Measurement
EP31JY24.353
§
PatientReported
OutcomeBased
Performan
ce Measure
Back Pain After Lumbar
Surgery:
For patients 18 years of age or
older who had a lumbar
discectomyllaminectomy or
fusion procedure, back pain is
rated by the patients as less
than or equal to 3.0 OR an
improvement of5.0 points or
greater on the Visual Analog
Scale (VAS) Pain scale or a
numeric pain scale at three
months (6 to 20 weeks)
postoperatively for
discectomy/laminectomy or at
one year (9 to 15 months)
postoperatively for lumbar
fusion patients. Rates are
stratified by procedure type;
lumbar
discectomy/laminectomy or
fusion rocedure.
Leg Pain After Lumbar
Surgery:
For patients 18 years of age or
older who had a lumbar
discectomy/laminectomy or
fusion procedure, leg pain is
rated by the patient as less than
or equal to 3.0 OR an
improvement of 5.0 points or
greater on the Visual Analog
Scale (VAS) Pain scale or a
numeric pain scale at three
months (6 to 20 weeks) for
discectomy/laminectomy or at
one year (9 to 15 months)
postoperatively for lumbar
fusion patients. Rates are
stratified by procedure type;
lumbar
discectomy/laminectomy or
fusion rocedure.
Functional Status After
Lumbar Surgery:
For patients age 18 and older
who had lumbar
discectomy/laminectomy or
fusion procedure, functional
status is rated by the patient as
less than or equal to 22 OR an
improvement of 30 points or
greater on the Oswestry
Disability Index (ODI version
2.la) at three months (6 to 20
weeks) postoperatively for
discectomy/laminectomy or at
one year (9 to 15 months)
postoperatively for lumbar
fusion patients. Rates are
stratified by procedure type;
lumbar discectomy or fusion
rocedure.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62397
B.24. Neurosurgical
!
(Equity)
NIAi
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487
NIA
*
NIAi
NIA
498
NIA
!
(Equity)
MIPS CQM
Specifications
MIPS CQM
Specifications
Process
Process
Screening for Social Drivers
of Health:
Centers for Medicare
Percent of patients 18 years and
older screened for food insecurit & Medicaid Services
housing instability, transportation
needs, utility difficulties, and
inter ersonal safet .
Connection to Community
Service Provider:
Percent of patients 18 years or
older who screen positive for
one or more of the following
health related social needs
(HRSNs): food insecurity,
housing instability,
OCHIN
transportation needs, utility
help needs, or interpersonal
safety; and had contact with a
Community Service Provider
(CSP) for at least I of their
HRSNs within 60 days after
screenin .
B.24. Neurosurgical
NA/
NA
NIA
MIPS CQM
Specification
MIPS CQM
Specification
Outcome
Outcome
Society for
Vascular
Surgeons
Centers for
Medicare &
Medicaid
Services
This measure is being
proposed for removal
beginning with the CY
2025 performance
periodl2027 MIPS
payment year. See Table
Group C for rationale.
EP31JY24.355
409
NIA
This measure is being
proposed for removal
beginning with the CY
2025 performance
period/2027 MIPS
payment year. See Table
Group C for rationale.
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Rate of Carotid
Endarterectomy (CEA) for
Asymptomatic Patients,
without Major
Complications (Discharged
to Home by PostOperative Day #2):
Percent of asymptomatic
patients undergoing Carotid
Endarterectomy (CEA) who
are discharged to home no
later than post-operative day
#2.
Clinical Outcome Post
Endovascular Stroke
Treatment: Percentage of
patients with a Modified
Rankin Score (mRS) score
of0 to 2 at 90 days
following endovascular
stroke intervention.
62398
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
B.25. Nutrition/Dietician
In addition to the considerations discussed in the introductory language of Table Group B of this Appendix to this proposed rule,
the Nutrition/Dietician specialty set takes additional criteria into consideration, which includes, but is not limited to: whether a
measure reflects current clinical guidelines, and the coding of the measure includes relevant clinician types. We may reassess the
appropriateness of individual measures, on a case-by-case basis, to ensure appropriate inclusion in the specialty set. Measure
tables in this set include previously finalized measures we are maintaining within the set, measures proposed to be added, and
measures proposed for removal, as applicable. We request comment on the measures available in the proposed Nutrition/
Dietician specialty set that have proposed substantive changes in Table Group D of this Appendix as indicated by an* in the
Indicator column.
B.25. Nutrition/Dietician
§
!
(Outcome)
0059 I
NIA
001
CMS12
2v13
130
CMS68
v14
eCQM
Specifications,
MIPS CQM
Specifications
Process
CMS2v
14
Medicare Part
B Claims
Measure
Specifications,
eCQM
Specifications,
MIPS CQM
Specifications
Process
NIA
Medicare Part
B Claims
Measure
Specifications,
MIPS CQM
Specifications
Process
*
§
!
(Patient
Safety)
§
NA/
NIA
*
!
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Outcome
Sfmt 4725
Diabetes: Hemoglobin Ale
(HbAlc) Poor Control
(>9%):
Percentage of patients 18-75
years of age with diabetes
who had hemoglobin Ale >
9.0% during the
measurement eriod.
Documentation of Current
Medications in the
Medical Record:
Percentage of visits for
patients aged 18 years and
older for which the eligible
clinician attests to
documenting a list of current
medications using all
immediate resources
available on the date of the
encounter.
Preventive Care and
Screening: Screening for
Depression and Follow-lip
Plan:
Percentage of patients aged
12 years and older screened
for depression on the date of
the encounter or up to 14
days prior to the date of the
encounter using an ageappropriate standardized
depression screening tool
AND if positive, a followup plan is documented on
the date ofor up to two days
after the date of the
uali in encounter.
Elder Maltreatment
Screen and Follow-Up
Plan:
Percentage of patients aged
60 years and older with a
documented elder
maltreatment screen using
an Elder Maltreatment
Screening tool on the date of
encounter AND a
documented follow-up plan
on the date of the positive
screen.
E:\FR\FM\31JYP2.SGM
31JYP2
National
Committee for
Quality Assurance
Centers for
Medicare &
Medicaid Services
Centers for
Medicare &
Medicaid Services
Centers for
Medicare &
Medicaid Services
EP31JY24.356
*
Medicare Part
B Claims
Measure
Specifications,
eCQM
Specifications,
MIPS CQM
S ecifications
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62399
B.25. Nutrition/Dietician
226
CMS13
8vl3
§
NIAi
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239
CMS15
5vl3
eCQM
Specifications
Process
§
2152 /
NIA
431
NIA
MIPS CQM
Specifications
Process
!
(Equity)
NIAi
NIA
487
NIA
MIPS CQM
Specifications
Process
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National
Committee for
Qua! ity Assurance
National
Committee for
Quality Assurance
National
Committee for
Qua! ity Assurance
Centers for
Medicare &
Medicaid Services
EP31JY24.357
Process
NIAi
NIA
§
lotter on DSK11XQN23PROD with PROPOSALS2
Medicare Part
B Claims
Measure
Specifications,
eCQM
Specifications,
MIPS CQM
Specifications
Preventive Care and
Screening: Tobacco Use:
Screening and Cessation
Intervention:
Percentage of patients aged
12 years and older who were
screened for tobacco use one
or more times during the
measurement period AND
who received tobacco
cessation intervention
during the measurement
period or in the six months
prior to the measurement
period if identified as a
tobacco user.
Weight Assessment and
Counseling for Nutrition
and Physical Activity for
Children/Adolescents:
Percentage of patients 3-17
years ofage who had an
outpatient visit with a
Primary Care Physician
(PCP) or
Obstetrician/Gynecologist
(OB/GYN) and who had
evidence of the following
during the measurement
period.
• Percentage of patients
with height, weight, and
body mass index (BMT)
percentile documentation
• Percentage of patients
with counseling for nutrition
• Percentage of patients
with counseling for physical
activi
Preventive Care and
Screening: Unhealthy
Alcohol Use: Screening &
Brief Counseling:
Percentage of patients aged
18 years and older who were
screened for unhealthy
alcohol use using a
systematic screening method
at least once within the last
12 months AND who
received brief counseling if
identified as an unhealthy
alcohol user.
Screening for Social
Drivers of Health:
Percent of patients 18 years
and older screened for food
insecurity, housing
instability, transportation
needs, utility difficulties,
and inter ersonal safe
62400
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
B.25. Nutrition/Dietician
.·cMs·
Measure Titl~
Md I)eseripti91i
*
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Connection to Community
Service Provider:
Percent of patients 18 years
or older who screen positive
for one or more of the
following health related
social needs (HRSNs): food
insecurity, housing
instability, transportation
needs, utility help needs, or
interpersonal safety; and had
contact with a Community
Service Provider (CSP) for
at least I of their HRSNs
within 60 days after
screenin .
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EP31JY24.358
eCQM
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Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62401
B.26. Obstetrics/Gynecology
In addition to the considerations discussed in the introductory language of Table Group B of this Appendix to this proposed rule,
the Obstetrics/Gynecology specialty set takes additional criteria into consideration, which includes, but is not limited to: whether
a measure reflects current clinical guidelines, and the coding of the measure includes relevant clinician types. We may reassess
the appropriateness of individual measures, on a case-by-case basis, to ensure appropriate inclusion in the specialty set. Measure
tables in this set include previously finalized measures we are maintaining within the set, measures proposed to be added, and
measures proposed for removal, as applicable. We request comment on the measures available in the proposed Obstetrics/
Gynecology specialty set.
B.26. Obstetrics/Gynecology
039
NIA
Process
Process
0326 /
NIA
047
NIA
Medicare Part
BClaims
Measure
Specifications,
MIPSCQM
Specifications
NIA/NIA
048
NIA
MIPSCQM
Specifications
Process
NIA/NIA
050
NIA
MIPSCQM
Specifications
Process
eCQM
Specifications,
MIPSCQM
Specifications
Process
*
(Care
Coordinatio
n)
!
(Patient
Experience)
*
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!
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Safety)
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Screening for Osteoporosis
for Women Aged 6S-8S
Years of Age:
Percentage of women aged
65-85 years of age who ever
had a central dual-energy Xray absorptiometry (DXA) to
check for osteo orosis.
Advance Care Plan:
Percentage of patients aged
65 years and older who have
an advance care plan or
surrogate decision maker
documented in the medical
record or documentation in
the medical record that an
advance care plan was
discussed but the patient did
not wish or was not able to
name a surrogate decision
maker or provide an advance
care Ian.
Urinary Incontinence:
Assessment of Presence or
Absence of Urinary
Incontinence in Women
Aged 65 Years and Older:
Percentage offemale patients
aged 65 years and older who
were assessed for the
presence or absence of
urinary incontinence within
12 months.
Urinary Incontinence: Plan
of Care for Urinary
Incontinence in Women
Aged 65 Years and Older:
Percentage offemale patients
aged 65 years and older with
a diagnosis of urinary
incontinence with a
documented plan of care for
urinary incontinence at least
once within 12 months.
Documentation of Current
Medications in the Medical
Record:
Percentage of visits for
patients aged 18 years and
older for which the eligible
clinician attests to
documenting a list of current
medications using all
immediate resources
available on the date of the
encounter.
E:\FR\FM\31JYP2.SGM
31JYP2
National
Committee for
Quality Assurance
National
Committee for
Quality Assurance
National
Committee for
Quality Assurance
National
Committee for
Quality Assurance
Centers for
Medicare&
Medicaid Services
EP31JY24.359
0046 I
NIA
Medicare Part
BClaims
Measure
Specifications,
MIPSCQM
Specifications
62402
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
8.26. Obstetrics/Gynecology
236
CMS165v
13
NIA/NIA
309
CMS124v
13
eCQM
Specifications
Process
NIA/NIA
310
CMS153v
13
eCQM
Specifications
Process
NIA/NIA
335
NIA
MIPS CQM
Specifications
Outcome
*
§
!
(Outcome)
§
§
!
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ate
Outcome
Sfmt 4725
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National
Committee for
Quality Assurance
National
Committee for
Quality Assurance
National
Committee for
Quality Assurance
Centers for
Medicare &
Medicaid Services
EP31JY24.360
NIA/NIA
Medicare Part
B Claims
Measure
Specifications,
eCQM
Specifications,
MIPS CQM
Specifications
Controlling High Blood
Pressure:
Percentage of patients 18-85
years of age who had a
diagnosis of essential
hypertension starting before
and continuing into, or
starting during the first six
months of the measurement
period, and whose most
recent blood pressure was
adequately controlled
(<140/90mmHg) during the
measurement eriod.
Cervical Cancer Screening:
Percentage of women 21-64
years of age who were
screened for cervical cancer
using either of the following
criteria:
• Women age 21-64 who had
cervical cytology performed
within the last 3 years
• Women age 30-64 who had
cervical human
papillomavirus (HPV) testing
performed within the last 5
ears
Chlamydia Screening in
Women:
Percentage of women 16-24
years of age who were
identified as sexually active
and who had at least one test
for chlamydia during the
measurement eriod.
Maternity Care: Elective
Delivery (Without Medical
Indication) at< 39 Weeks
(Overuse):
Percentage of patients,
regardless of age, who gave
birth during a 12-month
period, delivered a live
singleton at < 39 weeks of
gestation, and had elective
deliveries (without medical
indication) by cesarean birth
or induction of labor.
62403
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
B.26. Obstetrics/Gynecology
• < . tREVl(UiSLl;' FINAUZEllM.EASllIU:S IN tl:IEOBST£TRtCS/CVN£COLOCY SPECIALTY SEt
•.. ..
' CBE#f · Q11.alil:y
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Type
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336
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Process
CMS50vl
3
eCQM
Specifications,
MIPS CQM
Specifications
Process
NIA
Medicare Part
B Claims
Measure
Specifications,
MIPS CQM
Specifications
Process
NIA
Medicare Part
B Claims
Measure
Specifications,
MIPS CQM
Specifications
Process
*
!
(Care
Coordinatio
n)
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.
,''
and Desctlption.··
·
•• ..
,·'
''
.','
Maternity Care:
Postpartum Follow-up and
Care Coordination:
Percentage of patients,
regardless of age, who gave
birth during a 12-month
period who were seen for
postpartum care before or at
12 weeks of giving birth and
received the following at a
postpartum visit: breastfeeding evaluation and
education, postpartum
depression screening,
postpartum glucose screening
for gestational diabetes
patients, family and
contraceptive planning
counseling, tobacco use
screening and cessation
education, healthy lifestyle
behavioral advice, and an
immunization review and
update.
Closing the Referral Loop:
Receipt of Specialist
Report:
Percentage of patients with
referrals, regardless of age,
for which the referring
clinician receives a report
from the clinician to whom
the patient was referred.
Osteoporosis Management
in Women Who Had a
Fracture:
The percentage of women
50-85 years of age who
suffered a fracture and who
had either a bone mineral
density (BMD) test or
prescription for a drug to
treat osteoporosis in the six
months after the fracture.
Performing Cystoscopy at
the Time of Hysterectomy
for Pelvic Organ Prolapse
to Detect Lower Urinary
Tract Injury:
Percentage of patients who
undergo cystoscopy to
evaluate for lower urinary
tract injury at the time of
hysterectomy for pelvic
organ prolapse.
E:\FR\FM\31JYP2.SGM
31JYP2
·•·
...
Centers for
Medicare &
Medicaid Services
Centers for
Medicare &
Medicaid Services
National
Committee for
Quality Assurance
American
Urogynecologic
Society
EP31JY24.361
lodk!ttor
62404
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
8.26. Obstetrics/Gynecology
*
!
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Specifications
Process
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432
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MIPS CQM
Specifications
Outcome
NIA/NIA
443
NIA
MIPS CQM
Specifications
Process
NIA/NIA
448
NIA
MIPS CQM
Specifications
NIA/NIA
475
CMS349v
7
eCQM
Specifications
Process
NIA/NIA
487
NIA
MIPS CQM
Specifications
Process
(Outcome)
§
!
(Appropriat
e Use)
*
!
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National
Committee for
Quality Assurance
American
Urogynecologic
Society
Centers for
Medicare &
Medicaid Services
Centers for
Medicare &
Medicaid Services
Centers for Disease
Control and
Prevention
Centers for
Medicare &
Medicaid Services
EP31JY24.362
§
Preventive Care and
Screening: Unhealthy
Alcohol Use: Screening &
Brief Counseling:
Percentage of patients aged
18 years and older who were
screened for unhealthy
alcohol use using a
systematic screening method
at least once within the last
12 months AND who
received brief counseling if
identified as an unhealthy
alcohol user.
Proportion of Patients
Sustaining a Bladder
Injury at the Time of any
Pelvic Organ Prolapse
Repair:
Percentage of patients
undergoing pelvic organ
prolapse repairs who sustain
an injury to the bladder
recognized either during or
within 30 da s after sur er .
Non-Recommended
Cervical Cancer Screening
in Adolescent Females:
The percentage of adolescent
females 16-20 years of age
who were screened
unnecessarily for cervical
cancer.
Appropriate Workup Prior
to Endometrial Ablation:
Percentage of patients, aged
18 years and older, who
undergo endometrial
sampling or hysteroscopy
with biopsy and results are
documented before
undergoing an endometrial
ablation.
HIV Screening:
Percentage of patients aged
15-65 at the start of the
measurement period who
were between 15-65 years
old when tested for Human
Immunodeficiency Virus
HIV).
Screening for Social
Drivers of Health:
Percent of patients 18 years
and older screened for food
insecurity, housing
instability, transportation
needs, utility difficulties, and
inter ersonal safe! .
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62405
B.26. Obstetrics/Gynecology
493
NIA
MIPS CQM
Specifications
Process
NIA/NIA
496
NIA
MIPS CQM
Specifications
Process
*
NIA/NIA
497
NIA
MIPS CQM
Specifications
Process
*
!
(Equity)
NIA/NIA
498
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31JYP2
National
Committee for
Quality Assurance
University of
California, Irvine
Centers for
Medicare and
Medicaid Services
OCHIN
EP31JY24.363
3620 I
NIA
Adult Immunization
Status:
Percentage of patients 19
years of age and older who
are up-to-date on
recommended routine
vaccines for influenza;
tetanus and diphtheria (Td)
or tetanus, diphtheria and
acellular pertussis (Tdap);
zoster; and neumococcal.
Cardiovascular Disease
(CVD) Risk Assessment
Measure - Proportion of
Pregnant/Postpartum
Patients that Receive CVD
Risk Assessment with a
Standardized Instrument:
Percentage of pregnant or
postpartum patients who
received a cardiovascular
disease (CVD) risk
assessment with a
standardized instrument.
Preventive Care and
Wellness (composite):
Percentage of patients who
received age- and sexappropriate preventive
screenings and wellness
services. This measure is a
composite of seven
component measures that are
based on recommendations
for preventive care by the
U.S. Preventive Services
Task Force (USPSTF),AClP,
American Association of
Clinical Endocrinology
(AACE), and American
College of Endocrinology
ACE.
Connection to Community
Service Provider:
Percent of patients 18 years
or older who screen positive
for one or more of the
following health related
social needs (HRSNs): food
insecurity, housing
instability, transportation
needs, utility help needs, or
interpersonal safety; and had
contact with a Community
Service Provider (CSP) for at
least 1 of their HRSNs within
60 da s atler screen in .
62406
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
B.26. Obstetrics/Gynecology
PREVIO.lJSLY FTNALJZE:.)) MEASllRES
Indlca.tor
..
• •
*
!
(Outcome)
!
(Safety)
*
!
(Outcome)
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ill! THE OBS1'ETRICS/GYNECOLOGVSPECIAt1'\'SET
.
CoUeedon
Type·
eCQMJJ)
•·.·.
Measure
Type ..
PatientReported
OutcomeBased
Performan
ce
Measure
2483 /
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503
NIA
MIPS CQM
Specifications
NIA/NIA
504
NIA
MIPS CQM
Specifications
Process
MIPS CQM
Specifications
PatientReported
OutcomeBased
Performan
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Measure
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••. Melt$11re Tide
and De~cr/ptiou
Gains in Patient Activation
Measure (PAM®) Scores at
12 Months:
The Patient Activation
Measure® (PAM®) is a IOor 13 - item questionnaire
that assesses an individual's
knowledge, skills and
confidence for managing
their health and health care.
The measure assesses
individuals on a 0-100 scale
that converts to one of four
levels of activation, from low
(I) to high (4). The PAM®
performance measure
(PAM®-PM) is the change in
score on the PAM® from
baseline to follow-up
measurement.
Initiation, Review, And/Or
Update To Suicide Safety
Plan For Individuals With
Suicidal Thoughts,
Behavior, Or Suicide Risk:
Percentage of adult aged 18
years and older with suicidal
ideation or behavior
symptoms (based on results
of a standardized assessment
tool or screening tool) or
increased suicide risk (based
on the clinician's evaluation
or clinician-rating tool) for
whom a suicide safety plan is
initiated, reviewed, and/or
updated in collaboration
between the patient and their
clinician.
Reduction in Suicidal
Ideation or Behavior
Symptoms:
The percentage of patients
aged 18 and older with a
mental and/or substance use
disorder AND suicidal
thoughts, behaviors or risk
symptoms who demonstrated
a reduction in suicidal
ideation and/or behavior
symptoms based on results
from the Columbia-Suicide
Severity Rating Scale (CSSRS) 'Screen Version' or
'Since Last Visit' within 120
days after an index
assessment.
E:\FR\FM\31JYP2.SGM
31JYP2
I.
.·
..•.
Measure Steward .
Insignia Health,
LLC, a wholly
owned subsidiary
of Phreesia
American
Psychiatric
Association
American
Psychiatric
Association
EP31JY24.364
.•·
·· ......
•·
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62407
B.26. Obstetrics/Gynecology
101
102
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CQM
Specificati
ons
Process
Centers for
Medicare &
Medicaid
Services
See footnote lkeokwu et al., 2023 in Table B.l of this Appendix.
See footnotes Fitzpatrick et al., 2022; Polack et al., 2020; and Grana et al., 2022 in Table A.5 of this Appendix.
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NIA
Adult COVID-19
Vaccination
Status:
Percentage of
patients aged 18
years and older
seen for a visit
during the
performance
period that are up
to date on their
COVID-19
vaccinations as
defined by CDC
recommendations
on current
vaccination.
We are proposing to include this
measure in the Obstetrics/
Gynecology specialty set as it
would be clinically relevant to
this clinician type. Widespread
vaccination against SARS-CoV2, the virus that causes COVID19, is critically important to
stemming the morbidity and
mortality caused by this
disease. 101 Clinicians are
uniquely positioned to
encourage uptake of COVID-19
vaccination, and clinicians are
still a major driving force in
promoting patient vaccination.
The addition of this quality
measure in this specialty set
would help strengthen
compliance with recommended
COVID-19 vaccination, leading
to improvement in the quality of
patient care and prevention of
disease for the general
population. This quality measure
aligns with clinical guidelines
and the evidence-based
recommendations of the ACIP,
where there is general agreement
about the safety and efficacy of
the COVID-19 vaccine,
preventing costly and potentially
harmful hospitalizations. 102
Broadening vaccination status
awareness to this clinician type
is valuable as it can help drive
an increase in the adult
vaccination rates. The COVID19 vaccination included within
this measure would reduce the
prevalence of severe diseases
that may be associated with
hospitalization and decrease
overall health care costs. The
measure being added to this
specialty set would be
contingent on the inclusion of
applicable coding by the time of
the CY 2025 PFS final rule. In
the event appropriate coding is
not included in the fmal
specification, this measure
would not be finalized for
inclusion within this specialty
measure set. See Table A.5 of
this Appendix for rationale,
including clinical evidence
supporting the inclusion of this
measure in MIPS.
62408
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
B.26. Obstetrics/Gynecology
PREViotrsLY FINALT2:"ED J\,fEA$URESPRQfOSED. FOR RE.MOYALFROM tnE.Qll$TRETRTCS/<;Y~coLQGY
SPECIALT'.\' SET
•
Note:,J~_·thi.s p,oposed 11Jle, y\'~ ~re proppsin~the retnov~tofthefoifowin~ me;sute(s)hefow ftOJl\this specifrc'·speeialtr rne~sµre set base!!
upon.review .of updaws ml!de to ex:isting quality meas11re. specificatio:ns, the. proposed addition. qfnew ll)ea1i1;1res for inclµsior, in MIPS, ii.nd the
feedback rovided b s ecialt societies.
• • • • • •• • •
•. '
• ••• •
• ••••
••
••
CBE.#
I
eCQM
CBE#
NIAi
NIA
NIA
433
MIPS CQM
Specification
Outcome
Percentage of patients
undergoing surgical repair
of pel vie organ prolapse that
is complicated by a bowel
injury at the time of index
surgery that is recognized
intraoperatively or within 30
da s after sur e .
American
Urogynecologic Society
Appropriate Use of DXA
Scans in Women Under 65
Years Who Do Not Meet
the Risk Factor Profile for
Osteoporotic Fracture:
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Percentage of female
patients 50 to 64 years of
age without select risk
factors for osteoporotic
fracture who received an
order for a dual-energy xray absorptiometry (DXA)
scan during the
measurement eriod.
Fmt 4701
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Medicaid
Services
E:\FR\FM\31JYP2.SGM
31JYP2
This measure is being
proposed for removal
beginning with the CY
2025 performance
periodl2027 MIPS
payment year. See Table
Group C for rationale.
This measure is being
proposed for removal
beginning with the CY
2025 performance
periodl2027 MIPS
payment year. See Table
Group C for rationale.
EP31JY24.366
Proportion of Patients
Sustaining a Bowel Injury
at the time of any Pelvic
Organ Prolapse Repair:
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62409
B.27a. Oncology/Hematology
In addition to the considerations discussed in the introductory language of Table Group B of this Appendix to this proposed rule,
the Oncology/Hematology specialty set takes additional criteria into consideration, which includes, but is not limited to: whether
a measure reflects current clinical guidelines, and the coding of the measure includes relevant clinician types. We may reassess
the appropriateness of individual measures, on a case-by-case basis, to ensure appropriate inclusion in the specialty set. Measure
tables in this set include previously finalized measures we are maintaining within the set, measures proposed to be added, and
measures proposed for removal, as applicable. We request comment on the measures available in the proposed
Oncology/Hematology specialty set.
B.27a. Oncology/Hematology
!
(Care
Coordinati
on)
0326 I
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(Appropria
te Use)
NIAi
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102
CMSl
29v14
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Specifications,
MIPS CQM
Specifications
Process
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CMS6
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Specifications,
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Specifications
Process
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Claims Measure
Specifications,
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Specifications
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National
Committee for
Quality Assurance
Centers for
Medicare &
Medicaid Services
Centers for
Medicare &
Medicaid Services
Centers for
Medicare &
Medicaid Services
EP31JY24.367
*
Advance Care Plan:
Percentage of patients aged 65
years and older who have an
advance care plan or surrogate
decision maker documented in
the medical record or
documentation in the medical
record that an advance care plan
was discussed but the patient did
not wish or was not able to name
a surrogate decision maker or
rovide an advance care Ian.
Prostate Cancer: Avoidance of
Overuse of Bone Scan for
Staging Low Risk Prostate
Cancer Patients:
Percentage of patients,
regardless of age, with a
diagnosis of prostate cancer at
low (or very low) risk of
recurrence receiving interstitial
prostate brachytherapy, OR
external beam radiotherapy to
the prostate, OR radical
prostatectomy who did not have
a bone scan performed at any
time since diagnosis of prostate
cancer.
Documentation of Current
Medications in the Medical
Record:
Percentage of visits for patients
aged 18 years and older for which
the eligible clinician attests to
documenting a list of current
medications using all immediate
resources available on the date of
the encounter.
Preventive Care and
Screening: Screening for
Depression and Follow-lip
Plan:
Percentage of patients aged 12
years and older screened for
depression on the date of the
encounter or up to 14 days prior
to the date of the encounter using
an age-appropriate standardized
depression screening tool AND
if positive, a follow-up plan is
documented on the date of or up
to two days after the date of the
uali m encounter.
62410
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
8.27a. Oncology/Hematology
§
!
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Experience
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Specifications,
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Specifications,
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NIA
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Claims Measure
Specifications,
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Process
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American Society
of Clinical
Oncology
National
Committee for
Quality Assurance
National
Committee for
Quality Assurance
College of
American
Pathologists
Centers for
Medicare &
Medicaid Services
EP31JY24.368
*
Oncology: Medical and
Radiation - Pain Intensity
Quantified:
Percentage of patient visits,
regardless of patient age, with a
diagnosis of cancer currently
receiving chemotherapy or
radiation therapy in which pain
intensi is uantified.
Preventive Care and
Screening: Tobacco Use:
Screening and Cessation
Intervention:
Percentage of patients aged 12
years and older who were
screened for tobacco use one or
more times during the
measurement period AND who
received tobacco cessation
intervention during the
measurement period or in the six
months prior to the measurement
period if identified as a tobacco
user.
Use of High-Risk Medications
in Older Adults:
Percentage of patients 65 years
of age and older who were
ordered at least two high-risk
medications from the same drug
class.
Radical Prostatectomy
Pathology Reporting:
Percentage of radical
prostatectomy pathology reports
that include the pT category, the
pN category, the Gleason score
and a statement about margin
status.
Preventive Care and
Screening: Screening for High
Blood Pressure and Follow-Up
Documented:
Percentage of patient visits for
patients aged 18 years and older
seen during the measurement
period who were screened for
high blood pressure AND a
recommended follow-up plan is
documented, as indicated, if
blood pressure is elevated or
h ertensive.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62411
B.27a. Oncology/Hematology
!
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Survey Vendor
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Centers for
Medicare &
Medicaid Services
Centers for
Medicare &
Medicaid Services
National
Committee for
Quality Assurance
EP31JY24.369
§
CARPS for MIPs
Clinician/Group Survey:
The Consumer Assessment of
Healthcare Providers and
Systems (CAHPS) for MIPS
Clinician/Group Survey is
comprised of IO Summary
Survey Measures (SSMs) and
measures patient experience of
care within a group practice. The
CBE endorsement status and
endorsement id (if applicable)
for each SSM utilized in this
measure are as
follows:
• Getting Timely Care,
Appointments, and Information;
(Not endorsed by CBE)
• How well Providers
Communicate; (Not endorsed by
CBE)
• Patient's Rating of Provider;
(CBE endorsed # 0005)
• Access to Specialists; (Not
endorsed by CBE)
• Health Promotion and
Education; (Not endorsed by
CBE)
• Shared Decision-Making; (Not
endorsed by CBE)
• Health Status and Functional
Status; (Not endorsed by CBE)
• Courteous and Helpful Office
Staff; (CBE endorsed# 0005)
• Care Coordination; (Not
endorsed by CBE)
• Stewardship of Patient
Resources. (Not endorsed by
CBE.
Closing the Referral Loop:
Receipt of Specialist Report:
Percentage of patients with
referrals, regardless of age, for
which the referring clinician
receives a report from the
clinician to whom the patient
was referred.
Preventive Care and
Screening: Unhealthy Alcohol
Use: Screening & Brief
Counseling:
Percentage of patients aged 18
years and older who were
screened for unhealthy alcohol
use using a systematic screening
method at least once within the
last 12 months AND who
received brief counseling if
identified as an unhealthy
alcohol user.
62412
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8.27a. Oncology/Hematology
(Appropria
te Use)
*
§
§
!
(Appropria
te Use)
1858 I
NIA
1859 I
NIA
02101
NIA
450
NIA
MIPSCQM
Specifications
Process
451
NIA
MIPSCQM
Specifications
Process
453
NIA
MIPSCQM
Specifications
Process
457
NIA
MIPSCQM
Specifications
Process
462
CMS6
45v8
eCQM
Specifications
Process
487
NIA
MIPSCQM
Specifications
Process
§
!
0216 I
(Appropriat
e Use)
NIA
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*
(Equity)
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American Society
of Clinical
Oncology
American Society
of Clinical
Oncology
American Society
of Clinical
Oncology
American Society
of Clinical
Oncology
Oregon Urology
Institute
Centers for
Medicare&
Medicaid Services
EP31JY24.370
*
§
!
Appropriate Treatment for
Patients with Stage I (Tlc) III HER2 Positive Breast
Cancer:
Percentage offemale patients
aged 18 to 70 with stage I (Tl c)
- III HER2 positive breast
cancer for whom appropriate
treatment is initiated.
RAS (KRAS and NRAS) Gene
Mutation Testing Performed
for Patients with Metastatic
Colorectal Cancer who receive
Anti-epidermal Growth Factor
Receptor (EGFR) Monoclonal
Antibody Therapy: Percentage
ofadult patients (aged 18 or
over) with metastatic colorectal
cancer who receive antiepidermal growth factor receptor
monoclonal antibody therapy for
whom RAS (KRAS and NRAS)
gene mutation testing was
erformed.
Percentage of Patients Who
Died from Cancer Receiving
Systemic Cancer-Directed
Therapy in the Last 14 Days of
Life (lower score - better):
Percentage of patients who died
from cancer receiving systemic
cancer-directed therapy in the
last 14 da s oflife.
Percentage of Patients who
Died from Cancer Admitted to
Hospice for Less than 3 Days
(lower score - better):
Percentage of patients who died
from cancer and admitted to
hospice and spent less than 3
da s there.
Bone Density Evaluation for
Patients with Prostate Cancer
and Receiving Androgen
Deprivation Therapy:
Patients determined as having
prostate cancer who are currently
starting or undergoing androgen
deprivation therapy (ADT), for
an anticipated period of 12
months or greater and who
receive an initial bone density
evaluation. The bone density
evaluation must be prior to the
start of ADT or within 3 months
of the start of ADT.
Screening for Social Drivers of
Health:
Percent of patients 18 years and
older screened for food
insecurity, housing instability,
transportation needs, utility
difficulties, and interpersonal
safe
62413
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
B.27a. Oncology/Hematology
•,
· •· :PREVIOUStV.FINALTZED MEASURES IN THE ()N(:()LOGVtR}':lVJAT()LOGVSJ>.E:CJALTY SET
.,
.
CMS ·.•
CBE#/ . . .
I
Measure·····
Qu,lity
MeasnreTitle
.
.
eCQM
Mea~11rii Stewitrd ••
eCQ!\f .•
Collection''J::ype
> # ', •
'fype··
,•
• ·Indlcator
,·
.•
.
.
490
NIA
MIPS CQM
Specifications
*
3620 I
NIA
493
NIA
MIPS CQM
Specifications
!
(Equity)
3665 I
NIA
495
NIA
NIAi
NIA
498
NIA
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.
.
'· .TD
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.CBE#
*
!
(Outcome)
VerDate Sep<11>2014
.
,•
MIPS CQM
Specifications
MIPS CQM
Specifications
Frm 00819
Fmt 4701
.
,•
,,•·
and Descriptioll
Appropriate Intervention of
Immune-Related Diarrhea
and/or Colitis in Patients
Treated with Immune
Checkpoint Inhibitors:
Percentage of patients, aged 18
years and older, with a diagnosis
Process
of cancer, on immune checkpoint
inhibitor therapy, and grade 2 or
above diarrhea and/or grade 2 or
above colitis, who have immune
checkpoint inhibitor therapy held
and corticosteroids or
immunosuppressants prescribed
or administered.
Adult Immunization Status:
Percentage of patients 19 years
of age and older who are up-todate on recommended routine
vaccines for influenza; tetanus
Process
and diphtheria (Td) or tetanus,
diphtheria and acellular pertussis
(Tdap); zoster; and
oneumococcal.
Ambulatory Palliative Care
Patients' Experience of Feeling
Heard and Understood:
PatientThe percentage of top-box
Reported
responses among patients aged
Outcome18 years and older who had an
Based
ambulatory palliative care visit
Performance and report feeling heard and
Measure
understood by their pal Iiative
care clinician and team within 2
months (60 days) of the
ambulatory palliative care visit.
Connection to Community
Service Provider:
Percent of patients 18 years or
older who screen positive for
one or more of the following
health related social needs
(HRSNs): food insecurity,
Process
housing instability,
transportation needs, utility help
needs, or interpersonal safety;
and had contact with a
Community Service Provider
(CSP) for at least 1 of their
HRSNs within 60 days after
screening.
Sfmt 4725
E:\FR\FM\31JYP2.SGM
31JYP2
•• ..
Society for
lmmunotherapy of
Cancer (STTC)
National
Committee for
Quality Assurance
American
Academy of
Hospice and
Palliative
Medicine
(AAHPM)
OCHTN
EP31JY24.371
•
•,
62414
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
B.27a. Oncology/Hematology
.·
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*
!
(Outcome)
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EP31JY24.372
Indicator ..
PREVIOUSLY FINALIZED MEASURES IN THE ONCOLOGY/HEMATOL()GY SPECIALTY SET
CBE#/
CMS
. Quality
Measure
Measure Title
eCQM
eCQM C1>1lection Type
.· Measure Steward
Type
and Description
#
ID
CBE#
Gains in Patient Activation
Measure (PAM®) Scores at 12
Months:
The Patient Activation
Measure® (PAM®) is a 10- or
13 - item questionnaire that
Patientassesses an individual's
Insignia Health,
Reported
knowledge, skills and confidence
OutcomeLLC, a wholly
2483 I
MIPS CQM
for managing their health and
NIA
Based
owned subsidiary
503
NIA
Specifications
health care. The measure
of Phreesia
Performan
assesses individuals on a 0-100
ce Measure
scale that converts to one of four
levels of activation, from low (l)
to high (4). The PAM®
performance measure (PAM®PM) is the change in score on
the PAM® from baseline to
follow-up measurement.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62415
B.27a. Oncology/Hematology
!
103
104
VerDate Sep<11>2014
NIAi
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TBD
NIA
Process
Society
for
Immunot
herapy of
Cancer
(SITC)
See footnote Pai et al., 2020 in Table A.l of this Appendix
See footnotes Lim et al., 2015 and Pai et al., 2020 in Table A.l of this Appendix.
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(Appropri
ate Use)
MIPS
CQM
Specificati
ons
Positive PD-L1
Bio marker
Expression Test
Result Prior to
First-Line
Immune
Checkpoint
Inhibitor
Therapy:
Percentage of
patients, aged 18
years and older,
with a diagnosis
of metastatic
non-small cell
lung cancer or
squamous cell
carcinoma of
head and neck on
first-line immune
checkpoint
inhibitor (ICI)
therapy, who had
a positive PD-Ll
biomarker
expression test
result prior to
giving ICI
therapy.
We are proposing to include this
measure in the Oncology/
Hematology specialty set as it
would be clinically relevant to this
clinician type. Tmmunotherapy is
a rapidly developing and changing
subspecialty in the realm of
oncology, and this measure would
fill a gap within the oncologic
clinical topic. The incorporation
of this measure in this specialty
set would help promote
appropriate intervention and
timeliness of PD-LI biomarker
expression testing prior to
initiation of first-line treatment for
the metastatic non-small cell lung
cancer or squamous cell
carcinoma of head and neck. This
timeliness of treatment initiation
can lead to improvements in
patient mortality and morbidity. 103
It's important to address the
proper diagnosis of metastatic
non-small cell lung cancer or
squamous cell carcinoma that may
impact treatment decisions so that
appropriate treatment delivery is
not delayed, nor ineffective
therapies prescribed which could
both result in poor clinical
outcomes and unnecessary
healthcare costs. 104 See Table A. I
of this Appendix for rationale,
including clinical evidence
supporting the inclusion of this
measure in MIPS.
62416
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
B.27a. Oncology/Hematology
105
VerDate Sep<11>2014
TBD
NIA
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CQM
Specificati
ons
Process
American
Society
of
Clinical
Oncology
See footnote Konstantinopoulos et al., 2020 in Table A.2 of this Appendix.
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Appropriate
Germline
Testing for
Ovarian Cancer
Patients:
Percentage of
patients, aged 18
and older,
diagnosed with
epithelial
ovarian, fallopian
tube, or primary
peritoneal cancer
who undergo
germline testing
within 6 months
of diagnosis.
We are proposing to include this
measure in the Oncology/
Hematology specialty set as it
would be clinically relevant to this
clinician type and would fill a gap
within the oncologic clinical
topic. This measure addresses
patients diagnosed with epithelial
ovarian, fallopian tube, or primary
peritoneal cancer who undergo
germline testing within 6 months
of their diagnosis and is
predicated on existing clinical
guidelines and recommendations.
It also addresses a CMS priority
that could allow for more
personalized diagnostic,
predictive, prognostic, and
therapeutic strategies for the
patient. Current recommendations
for all women diagnosed with
ovarian cancer is to receive
genetic testing, however, only
approximately 30 percent of
women undergo any genetic
testing. 105 The high incidence of
these mutations and the advent of
therapy targeted toward BRCA
mutations warrant testing in all
individuals diagnosed with
ovarian cancer for the purpose of
determining treatment
recommendations, risk of other
cancers, and need for cascade
testing of family members. See
Table A.2 of this Appendix for
rationale, including clinical
evidence supporting the inclusion
of this measure in MIPS.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62417
8.27a. Oncology/Hematology
!
(Outcome
)
CBE
3720 /
NIA
TBD
TBD
NIA
NIA
MIPS
CQM
Specificati
ons
MIPS
CQM
Specificati
ons
Purchaser
Business
Group on
Health
PatientReported
Outcomebased
Performanc
e Measure
(PRO-PM)
PatientReported
Fatigue
Following
Chemotherapy
among Adults
with Breast
Cancer:
The PRO-PM
will assess
fatigue following
chemotherapy
administered
with curative
intent to adult
patients with
breast cancer.
Purchaser
Business
Group on
Health
106 Tegegn, H.K., & Gebreyohannes, E. A. (2017). Adequacy of Cancer Pain Management and Pain Interference
With Daily Functioning Among Patients Visiting the Oncology Ward of an Ethiopian University. Journal of Global
Oncology, 3(2). https://ascopubs.org/doi/10.1200/JGO.2017 .009738.
107 See footnote Tegegn & Gebreyohannes, 2017.
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!
(Outcome
)
CBE
3718 /
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PatientReported
Outcomebased
Performanc
e Measure
(PRO-PM)
PatientReported Pain
Interference
Following
Chemotherapy
among Adults
with Breast
Cancer: The
PRO-PM will
assess pain
interference
following
chemotherapy
administered
with curative
intent to adult
patients with
breast cancer.
We are proposing to include this
measure in the Oncology/
Hematology specialty set as it
would be clinically relevant to this
clinician type and would fill a gap
within the oncologic clinical
topic. This measure addresses a
CMS high priority as a patientreported outcome-based
performance quality measure
accounting for patient experience
of care for this patient population.
It is predicated on existing clinical
guidelines and
recommendations. 106 For the
breast cancer patient population,
it's important to routinely assess
pain to properly identify barriers
to acceptable pain management
and to intervene appropriately,
which can improve the patient's
health outcome and quality of
life_ rn7 See Table A.3 of this
Appendix for rationale, including
clinical evidence supporting the
inclusion of this measure in MIPS.
We are proposing to include this
measure in the Oncology/
Hematology specialty set as it
would be clinically relevant to this
clinician type, addresses a CMS
high priority as a PRO-PM, and
would fill a gap within the
oncologic clinical topic. It takes
into consideration the patient
voice/experience of care for those
patients with breast cancer with
fatigue experienced following
chemotherapy. PRO assessment in
routine care remains
underutilized, and very few PROPMs have been validated for the
cancer population. By taking into
consideration patient voice,
necessary interventions can be
completed to help improve their
quality oflife during cancer
treatment. See Table A.4 of this
Appendix for rationale, including
clinical evidence supporting the
inclusion of this measure in MIPS.
62418
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
B.27a. Oncology/Hematology
Adult COVTD-
108
109
VerDate Sep<11>2014
TBD
NIA
Process
Centers
for
Medicare
&
Medicaid
Services
See footnote lkeokwu et al., 2023 in Table B.l of this Appendix.
See footnotes Fitzpatrick et al., 2022; Polack et al., 2020; and Grana et al., 2022 in Table A.5 of this Appendix.
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MIPS
CQM
Specificati
ons
19 Vaccination
Status:
Percentage of
patients aged 18
years and older
seen for a visit
during the
performance
period that are up
to date on their
COVID-19
vaccinations as
defined by CDC
recommendation
son current
vaccination.
We are proposing to include this
measure in the Oncology/
Hematology specialty set as it
would be clinically relevant to this
clinician type. Widespread
vaccination against SARS-CoV-2,
the virus that causes COVlD-19,
is critically important to stemming
the morbidity and mortality
caused by this disease. 108
Clinicians are uniquely positioned
to encourage uptake ofCOVlD-19
vaccination, and clinicians are still
a major driving force in
promoting patient vaccination.
The addition of this quality
measure in this specialty set
would help strengthen compliance
with recommended COVID-19
vaccination, leading to
improvement in the quality of
patient care and prevention of
disease for the general population.
This quality measure aligns with
clinical guidelines and the
evidence-based recommendations
of the ACIP, where there is
general agreement about the
safety and efficacy of the COVID19 vaccine, preventing costly and
potentially harmful
hospitalizations. 109 Broadening
vaccination status awareness to
this clinician type is valuable as it
can help drive an increase in the
adult vaccination rates. The
COVID-19 vaccination included
within this measure would reduce
the prevalence of severe diseases
that may be associated with
hospitalization and decrease
overall health care costs. The
measure being added to this
specialty set would be contingent
on the inclusion of applicable
coding by the time of the CY
2025 PFS final rule. In the event
appropriate coding is not included
in the final specification, this
measure would not be finalized
for inclusion within this specialty
measure set. See Table A.5 of this
Appendix for rationale, including
clinical evidence supporting the
inclusion of this measure in MIPS.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62419
B.27a. Oncology/Hematology
PRtVIO(JSl,Y Ji'JNALTZED MEAStJRES P~OPOSED FOR: REMQVAL·FROl\f TJJE ONCOtOGV!HliMATOLOQY
SPECIALTY SE.T
Not~: In.this propo~ed i;ule, w~ are proposi~g the rempv~loftl:i~ following fue11s~re(~)bel6wtrom thissp~~.itic~pecl~lty meaSllfy s~t based •
• upon reyievv of updates made tp existingquaj ity 11')easµre specifications, the prQposed addition ofne;v .IT!easutes for i11clt1sion in MJf'.S;. andJh¢
feedback tovided b s e.cialt societies,·
CBE#
I
•
•
•
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NIA
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N/A
VerDate Sep<11>2014
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MIPS CQM
Specification
MIPS CQM
Specification
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Oncology: Medical and
Radiation - Plan of Care
for Pain:
Percentage of visits for
patients, regardless of age,
with a diagnosis of cancer
currently receiving
chemotherapy or radiation
therapy who report having
pain with a documented plan
of care to address ain.
Patients with Metastatic
Colorectal Cancer and
RAS (KRAS or NRAS)
Gene Mutation Spared
Treatment with Antiepidermal Growth Factor
Receptor (EGFR)
Monoclonal Antibodies:
Percentage of adult patients
(aged 18 or over) with
metastatic colorectal cancer
and RAS (KRAS or NRAS)
gene mutation spared
treatment with anti-EGFR
monoclonal antibodies.
Fmt 4701
Sfmt 4725
American
Society of
Clinical
Oncology
This measure is being
proposed for removal
beginning with the CY
2025 performance
period/2027 MIPS
payment year. See Table
Group C for rationale.
American
Society of
Clinical
Oncology
This measure is being
proposed for removal
beginning with the CY
2025 performance
period/2027 MIPS
payment year. See Table
Group C for rationale.
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CBE#
62420
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
B.27b. Radiation Oncology
In addition to the considerations discussed in the introductory language of Table Group B of this Appendix to this proposed rule,
the Radiation Oncology specialty set takes additional criteria into consideration, which includes, but is not limited to: whether a
measure reflects current clinical guidelines, and the coding of the measure includes relevant clinician types. We may reassess the
appropriateness of individual measures, on a case-by-case basis, to ensure appropriate inclusion in the specialty set. Measure
tables in this set include previously finalized measures we are maintaining within the set, measures proposed to be added, and
measures proposed for removal, as applicable. We request comment on the measures available in the proposed Radiation
Oncology specialty set.
B.27b. Radiation Oncology
!
(Appropriat
e Use)
NIAi
NIA
102
143
CMS
157vl
3
eCQM
Specifications,
MIPS CQM
Specifications
Process
CMS
138vl
3
Medicare Part
B Claims
Measure
Specifications,
eCQM
Specifications,
MIPS CQM
Specifications
Process
*
§
!
(Patient
Experience)
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VerDate Sep<11>2014
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0384e
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Specifications,
MIPS CQM
Specifications
CMS
129vl
4
226
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Centers for Medicare &
Medicaid Services
American Society of
Clinical Oncology
National Committee for
Quality Assurance
EP31JY24.378
§
Prostate Cancer: Avoidance of
Overuse of Bone Scan for
Staging Low Risk Prostate
Cancer Patients:
Percentage of patients, regardless
of age, with a diagnosis of
prostate cancer at low (or very
low) risk of recurrence receiving
interstitial prostate
brachytherapy, OR external beam
radiotherapy to the prostate, OR
radical prostatectomy who did
not have a bone scan performed
at any time since diagnosis of
rostate cancer.
Oncology: Medical and
Radiation - Pain Intensity
Quantified:
Percentage of patient visits,
regardless of patient age, with a
diagnosis of cancer currently
receiving chemotherapy or
radiation therapy in which pain
intensi IS uantified.
Preventive Care and Screening:
Tobacco Use: Screening and
Cessation Intervention:
Percentage of patients aged 12
years and older who were
screened for tobacco use one or
more times during the
measurement period AND who
received tobacco cessation
intervention during the
measurement period or in the six
months prior to the measurement
period if identified as a tobacco
user.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62421
8.27b. Radiation Oncology
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Specification
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This measure is being
proposed for removal
beginning with the CY
2025 performance
periodl2027 MIPS
payment year. See Table
Group C for rationale.
American
Society of
Clinical
Oncology
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0383 I
NIA
Oncology: Medical and
Radiation - Plan of Care
for Pain:
Percentage of visits for
patients, regardless of age,
with a diagnosis of cancer
currently receiving
chemotherapy or radiation
therapy who report having
pain with a documented plan
of care to address ain.
62422
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
B.28. Ophthalmology
In addition to the considerations discussed in the introductory language of Table Group B of this Appendix to this proposed rule,
the Ophthalmology specialty set takes additional criteria into consideration, which includes, but is not limited to: whether a
measure reflects current clinical guidelines, and the coding of the measure includes relevant clinician types. We may reassess the
appropriateness of individual measures, on a case-by-case basis, to ensure appropriate inclusion in the specialty set. Measure
tables in this set include previously finalized measures we are maintaining within the set, measures proposed to be added, and
measures proposed for removal, as applicable. We request comment on the measures available in the proposed Ophthalmology
specialty set that have proposed substantive changes in Table Group D of this Appendix as indicated by an* in the Indicator
column. As indicated in the Table Group B Introduction, we are proposing to rename this specialty set from "Ophthalmology/
Optometry" to "Ophthalmology" under this proposed rule. We are also proposing a new Optometry specialty set under Table
B.29 of this Appendix.
B.28. Ophthalmology
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!
(Care
Coordination)
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012
019
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3vl3
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Specifications
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CMS14
2v13
eCQM
Specifications,
MIPS CQM
Specifications
Process
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American Academy of
Ophthalmology
American Academy of
Ophthalmology
EP31JY24.380
NIAi
0086e
Primary Open-Angle
Glaucoma (POAG):
Optic Nerve
Evaluation:
Percentage of patients
aged 18 years and older
with a diagnosis of
primary open-angle
glaucoma (POAG) who
have an optic nerve
head evaluation during
one or more visits
within 12 months.
Diabetic Retinopathy:
Communication with
the Physician
Managing Ongoing
Diabetes Care:
Percentage of patients
aged 18 years and older
with a diagnosis of
diabetic retinopathy
who had a dilated
macular or fundus exam
performed with
documented
communication to the
physician who manages
the ongoing care of the
patient with diabetes
mellitus regarding the
findings of the macular
or fundus exam at least
once during the
erformance eriod.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62423
B.28. Ophthalmology
0055
§
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American Academy of
Ophthalmology
EP31JY24.381
*
Diabetes: Eye Exam:
Percentage of patients
18-75 years of age with
diabetes and an active
diagnosis ofretinopathy
in any part of the
measurement period
who had a retinal or
dilated eye exam by an
eye care professional
during the measurement
period or diabetics with
no diagnosis of
retinopathy in any part
of the measurement
period who had a retinal
or dilated eye exam by
an eye care professional
during the measurement
period or in the 12
months prior to the
measurement eriod.
Documentation of
Current Medications
in the Medical Record:
Percentage of visits for
patients aged 18 years
and older for which the
eligible clinician attests
to documenting a list of
current medications
using all immediate
resources available on
the date of the
encounter.
Primary Open-Angle
Glaucoma (POAG):
Reduction of
Intraocnlar Pressure
(TOP) by 20% OR
Documentation of a
Plan of Care:
Percentage of patients
aged 18 years and older
with a diagnosis of
primary open-angle
glaucoma (POAG)
whose glaucoma
treatment has not failed
(the most recent TOP
was reduced by at least
20% from the preintervention level) OR if
the most recent !OP was
not reduced by at least
20% from the preintervention level, a
plan ofcare was
documented within the
12 month performance
eriod.
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National Committee for
Quality Assurance
National Committee for
Quality Assurance
EP31JY24.382
!
(Outcome)
Cataracts: 20140 or
Better Visual Acuity
within 90 Days
Following Cataract
Surgery:
Percentage of cataract
surgeries for patients age
18 years and o Ider with a
diagnosis of
uncomplicated cataract
and no significant ocular
conditions impacting the
visual outcome of surgery
and had best-corrected
visual acuity of 20140 or
better (distance or near)
achieved in the operative
eye within 90 days
following the cataract
sur e
Preventive Care and
Screening: Tobacco
Use: Screening and
Cessation
Intervention:
Percentage of patients
aged 12 years and older
who were screened for
tobacco use one or more
times during the
measurement period
AND who received
tobacco cessation
intervention during the
measurement period or in
the six months prior to the
measurement period if
identified as a tobacco
user.
Use of High-Risk
Medications in Older
Adults:
Percentage of patients
65 years of age and
older who were ordered
at least two high-risk
medications from the
same dru class.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
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Ophthalmology
American Academy of
Ophthalmology
Centers for Medicare &
Medicaid Services
American Academy of
Ophthalmology
EP31JY24.383
!
(Outcome)
Cataracts:
Improvement in
Patient's Visual
Function within 90
Days Following
Cataract Surgery:
Percentage of patients
Patientaged 18 years and older
Reported
who had cataract
Outcomesurgery and had
Based
improvement in visual
Performanc
function achieved
eMeasure
within 90 days
following the cataract
surgery, based on
completing a preoperative and postoperative visual
function surve .
Cataracts: Patient
Satisfaction within 90
Days Following
Cataract Surgery:
Percentage of patients
aged 18 years and older
who had cataract
Patient
surgery and were
Engagement/ satisfied with their care
Experience
within 90 days
following the cataract
surgery, based on
completion of the
Consumer Assessment
of Healthcare Providers
and Systems Surgical
Care Surve .
Closing the Referral
Loop: Receipt of
Specialist Report:
Percentage of patients
with referrals,
regardless of age, for
Process
which the referring
clinician receives a
report from the clinician
to whom the patient was
referred.
Adult Primary
Rhegmatogenous
Retinal Detachment
Surgery: No Return to
the Operating Room
Within 90 Days of
Surgery:
Outcome
Patients aged 18 years
and older who had
surgery for primary
rhegmatogenous retinal
detachment who did not
require a return to the
operating room within
90 da s ofsur e
62426
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B.28. Ophthalmology
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American Academy of
Ophthalmology
American Academy of
Ophthalmology
Centers for Medicare &
Medicaid Services
OCHTN
EP31JY24.384
!
(Outcome)
Adult Primary
Rhegmatogenous
Retinal Detachment
Surgery: Visual Acuity
Improvement Within
90 Days of Surgery:
Patients aged 18 years
and older who had
surgery for primary
rhegmatogenous retinal
detachment and
achieved an
improvement in their
visual acuity, from their
preoperative level,
within 90 days of
surgery in the operative
e e.
Cataract Surgery:
Difference Between
Planned and Final
Refraction:
Percentage of patients
aged 18 years and older
who had cataract
surgery performed and
who achieved a final
refraction within +I- 1.0
diopters of their planned
tar et refraction.
Screening for Social
Drivers of Health:
Percent of patients 18
years and older screened
for food insecurity,
housing instability,
transportation needs,
utility difficulties, and
inte ersonal safe
Connection to
Community Service
Provider:
Percent of patients 18
years or older who
screen positive for one
or more of the following
health related social
needs (HRSNs): food
insecurity, housing
instability,
transportation needs,
utility help needs, or
interpersonal safety; and
had contact with a
Community Service
Provider (CSP) for at
least 1 of their HRSN s
within 60 days after
screenin .
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Appropriate Screening
and Plan of Care for
Elevated lntraocular
Pressure Following
lntravitreal or
Periocular Steroid
Therapy:
Percentage of patients
who had an intravitreal
or periocular
corticosteroid injection
(e.g., triamcinolone,
preservative-free
triamcinolone,
dexamethasone,
dexamethasone
intravitreal implant, or
fluocinolone intravitreal
implant) who, within
seven (7) weeks
following the date of
injection, are screened
for elevated intraocular
pressure OOP) with
tonometry with
documented TOP =<25
mm Hg for injected eye
OR if the IOP was >25
mm Hg, a plan of care
was documented.
Acute Posterior
Vitreous Detachment
Appropriate
Examination and
Follow-up:
Percentage of patients
with a diagnosis of
acute posterior vitreous
detachment (PVD) in
either eye who were
appropriately evaluated
during the initial exam
and were re-evaluated
no later than 8 weeks.
Acute Posterior
Vitreous Detachment
and Acute Vitreous
Hemorrhage
Appropriate
Examination and
Follow-up:
Percentage of patients
with a diagnosis of
acute posterior vitreous
detachment (PVD) and
acute vitreous
hemorrhage in either
eye who were
appropriately evaluated
during the initial exam
and were re-evaluated
no later than 2 weeks.
E:\FR\FM\31JYP2.SGM
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Retina Specialists
American Society of
Retina Specialists
American Society of
Retina Specialists
EP31JY24.385
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62428
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
B.29. Optometry
As indicated in the introductory language of Table Group B of this Appendix to this proposed rule, we are proposing to add a
new Optometry specialty set. In addition to the considerations discussed in the introductory language of Table Group B, the
Optometry specialty set takes additional criteria into consideration, which includes, but is not limited to: whether a measure
reflects current clinical guidelines, and the coding of the measure includes relevant clinician types. We may reassess the
appropriateness of individual measures, on a case-by-case basis, to ensure appropriate inclusion in the specialty set. Measure
tables in this set include previously finalized measures we are proposing to add to this specialty set. We request comment on the
measures available in the proposed Optometry specialty set.
B.29. Optometry
*
!
(Care
Coordinat
ion)
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142vl
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eCQM
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s,MIPS
CQM
Specification
Process
Diabetic
Retinopathy:
Communicati
on with the
Physician
Managing
Ongoing
Diabetes
Care:
Percentage of
patients aged
18 years and
older with a
diagnosis of
diabetic
retinopathy
who had a
dilated
macularor
fundus exam
performed
with
documented
communicatio
n to the
physician who
manages the
ongoing care
of the patient
with diabetes
mellitus
regarding the
findings of the
macularor
fundusexam
at least once
during the
performance
period.
American
Academy of
Ophthalmolog
y
We are proposing to include
this measure in the Optometry
specialty set as it would be
clinically relevant to this
clinician type. An
Optometrist is needed to
inform a primary care
clinician about a particular
patient's retinopathy severity,
possible diabetic macular
edema, or other ocular comorbidities. Retinopathy
serves as a strong predictor of
other serious medical
conditions such as heart
attack, stroke, kidney failure,
amputation, and others. uo
Without regular reporting
from the optometrist on this
issue, the primary care
clinician lacks valuable
information key to the overall
management of the patient.
This measure is essential to
patient safety and completes
the feedback essential for
treating a deadly, common
disease. 111 Better
communication between eye
specialists and primary care
clinicians can play a critical
role in patient care, as it's an
important mechanism for
clinicians to communicate
with one another about a
patients' disease symptoms,
adherence to care plan, and
treatment plans. 112 The
measure being added to this
specialty set would be
contingent on the inclusion of
applicable coding by the time
of the CY 2025 PFS final
rule.
Nag, S., Bilous, R., Kelly, W., Jones, S., Roper, N., & Connolly, V. (2007). All-cause and Cardiovascular Mortality in
Diabetic Subjects Increases Significantly with Reduced Estimated Glomerular Filtration Rate (eGFR): 10 Years' Data
from the South Tees Diabetes Mortality Study. Diabetic Medicine: A Journal of the British Diabetic
Association, 24(1), 10-17. https://doi.org/10.llll/j.1464-5491.2007 .02023.x.
111 Reutens A. T. (2013). Epidemiology of Diabetic Kidney Disease. The Medical Clinics of North America, 97{1), 118. https://doi.org/10.1016/j.mcna.2012.10.001.
112 Storey, P., and Haller, J. (2016). The Significance of Physician Communication in the Care of Patients With
Diabetes. Retina Today. https://retinatoday.com/articles/2016-sept/the-significance-of-physician-communicationin-the-care-of-patients-with-diabetes.
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62429
B.29. Optometry
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Documentati
on of Current
Medications
in the
Medical
Record:
Percentage of
visits for
patients aged
18 years and
older for
which the
eligible
clinician
attests to
documenting a
list of current
medications
using all
immediate
resources
available on
the date of the
encounter.
Sfmt 4725
National
Committee for
Quality
Assurance
Centers for
Medicare&
Medicaid
Services
E:\FR\FM\31JYP2.SGM
We are proposing to include
this measure in the Optometry
specialty set as it would be
clinically relevant to this
clinician type. This measure
could help accurately assess a
clinician's ability to diagnose
and treat patients safely and
efficiently. We believe the
numerator options, give more
granular data can be captured
to discern between patients
with and without evidence of
retinopathy. This information
could give insight into those
patients with controlled blood
sugar and those with
uncontrolled blood sugar The
measure being added to this
specialty set would be
contingent on the inclusion of
applicable coding by the time
of the CY 2025 PFS final
rule.
We are proposing to include
this measure in the Optometry
specialty set as it is clinically
relevant to this clinician type.
Documentation of current
medications in the medical
record facilitates the process
of medication review and
reconciliation by the
clinician, which is necessary
for reducing ADEs and
promoting medication safety.
The need for clinician-toclinician coordination
regarding medication records,
and the existing gap in
implementation, is
highlighted in the American
Medical Association's
Physician's Role in
Medication Reconciliation,
which states that "critical
patient information, including
medical and medication
histories, current medications
the patient is receiving and
taking, and sources of
medications, is essential to
31JYP2
EP31JY24.387
*
CMS
131v1
Diabetes: Eye
Exam:
Percentage of
patients 18-75
years of age
with diabetes
and an active
diagnosis of
retinopathy in
any part of the
measurement
period who
had a retinal
or dilated eye
exam by an
eye care
professional
during the
measurement
period or
diabetics with
no diagnosis
of retinopathy
in any part of
the
measurement
period who
had a retinal
or dilated eye
exam by an
eye care
professional
during the
measurement
period or in
the 12 months
prior to the
measurement
riod.
62430
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
B.29. Optometry
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Specification
s,MIPS
CQM
Specification
Process
Process
Use of HighRisk
Medications
in Older
Adults:
Percentage of
patients 65
years of age
and older who
were ordered
at least two
high-risk
medications
from the same
drug class.
National
Committee for
Quality
Assurance
National
Committee for
Quality
Assurance
We are proposing to include
this measure in the Optometry
specialty set as it is clinically
relevant to this clinician type.
Treating patients with highrisk medications such as antidepressants or pain
medications, may be
associated with increased risk
of harm from drug sideeffects and toxicity. ll5
Medication errors can occur
anywhere throughout the
many steps in the medication
management process, with
one of the most common
113 American Medical Association. {2007). The Physician's Role in Medication Reconciliation: Issues, Strategies, and
Safety Principles. Retrieved from https://brucelambert.soc.northwestern.edu//book_reviews/med-recmonograph.pdf.
114 CDC. (2023). Smoking and Tobacco Use -Adult Data.
https://www.cdc.gov/tobacco/data_statistics/fact_sheets/adult_data/cig_smoking/index.htm.
115 Zhan, C., Sangi, J., Bierman, A. S., Miller, M. R., Friedman, B., Wickizer, S. W., & Meyer, G. S. (2001). Potentially
Inappropriate Medication Use in the Community-Dwelling Elderly: Findings from the 1996 Medical Expenditure
Panel Survey. JAMA, 286(22), 2823-2829. https://doi.org/10.1001/jama.286.22.2823.
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CMS
138vl
3
Medicare
Part B
Claims
Measure
Specification
s,eCQM
Specification
s,MIPS
CQM
Specification
s
Preventive
Care and
Screening:
Tobacco Use:
Screening
and
Cessation
Intervention:
Percentage of
patients aged
12 years and
older who
were screened
for tobacco
use one or
more times
during the
measurement
period AND
who received
tobacco
cessation
intervention
during the
measurement
period or in
the six months
prior to the
measurement
period if
identified as a
tobacco user.
the delivery of safe medical
care. " 113 The measure being
added to this specialty set
would be contingent on the
inclusion ofapplicable coding
by the time of the CY 2025
PFS final rule.
We are proposing to include
this measure in the Optometry
specialty set as it is clinically
relevant to this clinician type.
Tobacco use is the leading
preventable cause of disease,
disability, and death in the
U.S. cigarette smoking results
in more than 480,000
premature deaths each year
and accounts for
approximately 1 in every 5
deaths. 114 Due to the harmful
effect tobacco use can have
on patients' health, we
believe that clinicians should
engage with their patients to
screen for tobacco use and, if
positive, provide tobacco
cessation counseling
annually. The measure being
added to this specialty set
would be contingent on the
inclusion of applicable coding
by the time of the CY 2025
PFS final rule.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62431
B.29. Optometry
*
!
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50vl3
Process
Centers for
Medicare&
Medicaid
Services
Pereira, F., Bieri, M., Del Rio Carral, M., Martins, M. M., & Verloo, H. (2022}. Collaborative Medication
Management for Older Adults After Hospital Discharge: A Qualitative Descriptive Study. BMC Nursing, 21(1), 284.
https://doi.org/10. l 186/s12912-022-01061-3.
116
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eCQM
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s, MIPS
CQM
Specification
s
Closing the
Referral
Loop:
Receipt of
Specialist
Report:
Percentage of
patients with
referrals,
regardless of
age, for which
the referring
clinician
receives a
report from
the clinician to
whom the
patient was
referred.
error sources being poor
interprofessional
communication resulting in
poor collaborative medication
management. 116 The measure
being added to this specialty
set would be contingent on
the inclusion of applicable
coding by the time of the CY
2025 PFS final rule.
We are proposing to include
this measure in the Optometry
specialty set as it is clinically
relevant to this clinician type.
Including this measure would
ensure patients referred to
Optometrist for a consultation
complete the encounter with a
consult report being returned
to the referring physician.
The measure being added to
this specialty set would be
contingent on the inclusion of
applicable coding by the time
of the CY 2025 PFS final
rule.
62432
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
8.30. Orthopedic Surgery
In addition to the considerations discussed in the introductory language of Table Group B of this Appendix to this proposed rule,
the Orthopedic Surgery specialty set takes additional criteria into consideration, which includes, but is not limited to: whether a
measure reflects current clinical guidelines, and the coding of the measure includes relevant clinician types. We may reassess the
appropriateness of individual measures, on a case-by-case basis, to ensure appropriate inclusion in the specialty set. Measure
tables in this set include previously finalized measures we are maintaining within the set, measures proposed to be added, and
measures proposed for removal, as applicable. We request comment on the measures available in the proposed Orthopedic
Surgery specialty set that have proposed substantive changes in Table Group D of this Appendix as indicated by an* in the
Indicator column.
8.30. Orthopedic Surgery
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Process
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!
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Coordination
)
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National Committee for
Quality Assurance
National Committee for
Quality Assurance
Centers for Medicare &
Medicaid Services
EP31JY24.390
!
(Care
Coordination
)
Communication with the
Physician or Other
Clinician Managing OnGoing Care Post-Fracture
for Men and Women Aged
50 Years and Older:
Percentage of patients aged
50 years and older treated
for a fracture with
documentation of
communication, between
the physician treating the
fracture and the physician
or other clinician managing
the patient's on-going care,
that a fracture occurred and
that the patient was or
should be considered for
osteoporosis treatment or
testing. This measure is
submitted by the physician
who treats the fracture and
who therefore is held
accountable for the
communication.
Advance Care Plan:
Percentage of patients aged
65 years and older who
have an advance care plan
or surrogate decision
maker documented in the
medical record or
documentation in the
medical record that an
advance care plan was
discussed but the patient
did not wish or was not
able to name a surrogate
decision maker or provide
an advance care Ian.
Documentation of
Current Medications in
the Medical Record:
Percentage of visits for
patients aged 18 years and
older for which the eligible
clinician attests to
documenting a list of
current medications using
all immediate resources
available on the date of the
encounter.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62433
B.30. Orthopedic Surgery
§
*
!
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PREVIOUSLY FINALIZED -MEASURES IN THE ORTHOPEDlCSURGERYSPECIALTY SET
CBE#
CMS
Measure Title a:nd
Quality
I
Collection
Measure
eCQM
Measure Steward
Type
#
Type
Description
eCQM
JD
CBE#
Preventive Care and
Screening: Screening for
Depression and FollowUp Plan:
Percentage of patients aged
Medicare Part
12 years and older
B Claims
screened for depression on
Measure
the date of the encounter or
Specifications,
NIAi
up to 14 days prior to the
Centers for Medicare &
CMS2v
134
Process
NIA
14
eCQM
date of the encounter using
Medicaid Services
Specifications,
an age-appropriate
MIPS CQM
standardized depression
Specifications
screening tool AND if
positive, a follow-up plan
is documented on the date
of or up to two days after
the date of the qualifying
encounter.
Falls: Plan of Care:
Medicare Part
Percentage of patients aged
B Claims
65 years and older with a
0101 I
National Committee for
Measure
155
NIA
Process
history of falls who had a
Quality Assurance
NIA
Specifications,
plan of care for falls
MIPS CQM
documented within 12
Specifications
months.
Rheumatoid Arthritis
(RA): Functional Status
Assessment:
Percentage of patients aged
18 years and older with a
American College of
MIPS CQM
NIAi
178
NIA
Process
diagnosis of rheumatoid
Rheumatology
NIA
Specifications
arthritis (RA) for whom a
functional status
assessment was performed
at least once during the
performance period.
Rheumatoid Arthritis
(RA): Glucocorticoid
Management:
Percentage of patients aged
18 years and older with a
diagnosis of rheumatoid
arthritis (RA) who have
been assessed for
MIPS CQM
glucocorticoid use and, for
NIAi
American College of
180
NIA
Process
NIA
Specifications
those on prolonged doses
Rheumatology
ofprednisone > 5 mg daily
(or equivalent) with
improvement or no change
in disease activity,
documentation of
glucocorticoid
management plan during
the performance period.
62434
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Performance
Measure
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Performance
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Outcomes, Inc.
EP31JY24.392
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Functional Outcome
Assessment:
Percentage of visits for
patients aged 18 years and
older with documentation
of a current functional
outcome assessment using
a standardized functional
outcome assessment tool
on the date of the
encounter AND
documentation of a care
plan based on identified
functional outcome
deficiencies within two
days of the date of the
identified deficiencies.
Functional Status
Change for Patients with
Knee Impairments:
A patient-reported
outcome measure (PROM)
of risk-adjusted change in
functional status (FS) for
patients 14 years+ with
knee impairments. The
change in FS is assessed
using the FOTO Lower
Extremity Physical
Function (LEPF) PROM.
The measure is adjusted to
patient characteristics
known to be associated
with FS outcomes (riskadjusted) and used as a
performance measure at
the patient, individual
clinician, and clinic levels
to assess uali
Functional Status
Change for Patients with
Hip Impairments:
A patient-reported
outcome measure (PROM)
ofrisk-adjusted change in
functional status (FS) for
patients 14 years+ with hip
impairments. The change
in FS is assessed using the
FOTO Lower Extremity
Physical Function (LEPF)
PROM. The measure is
adjusted to patient
characteristics known to be
associated with FS
outcomes (risk adjusted)
and used as a performance
measure at the patient,
individual clinician, and
clinic levels to assess
uali
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MIPSCQM
Specifications
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Performance
Measure
MIPSCQM
Specifications
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Performance
Measure
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Outcomes, Inc.
EP31JY24.393
!
(Outcome)
PatientReported
OutcomeBased
Performance
Measure
Functional Status
Change for Patients with
Lower Leg, Foot or
Ankle Impairments:
A patient-reported
outcome measure (PROM)
of risk-adjusted change in
functional status (FS) for
patients 14 years+ with
foot, ankle or lower leg
impainnents. The change
in FS is assessed using the
FOTO Lower Extremity
Physical Function (LEPF)
PROM. The measure is
adjusted to patient
characteristics known to be
associated with FS
outcomes (risk-adjusted)
and used as a performance
measure at the patient,
individual clinician, and
clinic levels to assess
uali
Functional Status
Change for Patients with
Low Back Impairments:
A patient-reported
outcome measure (PROM)
ofrisk-adjusted change in
functional status (FS) for
patients 14 years+ with
low back impairments. The
change in FS is assessed
using the FOTO Low Back
FS PROM. The measure is
adjusted to patient
characteristics known to be
associated with FS
outcomes (risk adjusted)
and used as a performance
measure at the patient,
individual clinician, and
clinic levels to assess
uali
Functional Status
Change for Patients with
Shoulder Impairments:
A patient-reported
outcome measure (PROM)
of risk-adjusted change in
functional status (FS) for
patients 14 years+ with
shoulder impairments. The
change in FS is assessed
using the FOTO Shoulder
FS PROM. The measure is
adjusted to patient
characteristics known to be
associated with FS
outcomes (risk adjusted)
and used as a performance
measure at the patient,
individual clinician, and
clinic levels to assess
ualit
62436
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B.30. Orthopedic Surgery
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Safety)
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Centers for Medicare &
Medicaid Services
National Committee for
Quality Assurance
EP31JY24.394
!
(Outcome)
PatientReported
OutcomeBased
Performance
Measure
Functional Status
Change for Patients with
Elbow, Wrist or Hand
Impairments:
A patient-reported
outcome measure (PROM)
ofrisk-adjusted change in
functional status (FS) for
patients 14 years+ with
elbow, wrist, or hand
impairments. The change
in FS is assessed using the
FOTO Elbow/Wrist/Hand
FS PROM. The measure is
adjusted to patient
characteristics known to be
associated with FS
outcomes (risk adjusted)
and used as a performance
measure at the patient,
individual clinician, and
clinic levels to assess
uali
Preventive Care and
Screening: Tobacco Use:
Screening and Cessation
Intervention:
Percentage of patients aged
12 years and older who
were screened for tobacco
use one or more times
during the measurement
period AND who received
tobacco cessation
intervention during the
measurement period or in
the six months prior to the
measurement period if
identified as a tobacco
user.
Preventive Care and
Screening: Screening for
High Blood Pressure and
Follow-Up Documented:
Percentage of patient visits
for patients aged 18 years
and older seen during the
measurement period who
were screened for high
blood pressure AND a
recommended follow-up
plan is documented, as
indicated, if blood pressure
is elevated or h ertensive.
Falls: Screening for
Future Fall Risk:
Percentage of patients 65
years of age and older who
were screened for future
fall risk during the
measurement eriod.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
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8.30. Orthopedic Surgery
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!
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Experience)
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Specifications
Process
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351
NIA
MIPS CQM
Specifications
Process
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358
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Specifications
Process
374
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American Association
of Hip and Knee
Surgeons
American Association
of Hip and Knee
Surgeons
American College of
Surgeons
Centers for Medicare &
Medicaid Services
EP31JY24.395
!
(Care
Coordination
)
Total Knee or Hip
Replacement: Shared
Decision-Making: Trial of
Conservative (Nonsurgical) Therapy:
Percentage of patients
regardless of age
undergoing a total knee or
total hip replacement with
documented shared
decision- making with
discussion of conservative
(non-surgical) therapy
(e.g., non-steroidal antiinflammatory drug
(NSA!Ds), analgesics,
weight loss, exercise,
injections) prior to the
rocedure.
Total Knee or Hip
Replacement: Venous
Thromboembolic and
Cardiovascular Risk
Evaluation:
Percentage of patients
regardless ofage undergoing
a total knee or total hip
replacement who are
evaluated for the presence or
absence of venous
thromboembolic and
cardiovascular risk factors
within 30 days prior to the
procedure (e.g., History of
Deep Vein Thrombosis
(DVT), Pulmonary
Embolism (PE), Myocardial
Infarction (MI), Arrhythmia
and Stroke .
Patient-Centered
Surgical Risk Assessment
and Communication:
Percentage of patients who
underwent a nonemergency surgery who
had their personalized risks
of postoperative
comp Iications assessed by
their surgical team prior to
surgery using a clinical
data-based, patient-specific
risk calculator and who
received personal
discussion of those risks
with the sur eon.
Closing the Referral
Loop: Receipt of
Specialist Report:
Percentage of patients with
referrals, regardless of age,
for which the referring
clinician receives a report
from the clinician to whom
the atient was referred.
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National Committee for
Quality Assurance
Minnesota
Community
Measurement
EP31JY24.396
*
Functional Status
Assessment for Total Hip
Replacement:
Percentage of patients 19
years of age and older who
received an elective primary
total hip arthroplasty (THA)
and completed a functional
status assessment within 90
days prior to the surgery and
in the 300 - 425 days after
the sur er .
Osteoporosis
Management in Women
Who Had a Fracture:
The percentage of women
50-85 years of age who
suffered a fracture and who
had either a bone mineral
density (BMD) test or
prescription for a drug to
treat osteoporosis in the six
months after the fracture.
Back Pain After Lumbar
Surgery:
For patients 18 years of
age or older who had a
lumbar
discectomyllaminectomy
or fusion procedure, back
pain is rated by the patients
as less than or equal to 3 .0
OR an improvement of 5 .0
points or greater on the
Visual Analog Scale
(VAS) Pain scale or a
numeric pain scale at three
months (6 to 20 weeks)
postoperatively for
discectomyllaminectomy
or at one year (9 to 15
months) postoperatively
for lumbar fusion patients.
Rates are stratified by
procedure type; lumbar
discectomyllaminectomy
or fusion rocedure.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
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Minnesota
Community
Measurement
Minnesota Community
Measurement
Minnesota Community
Measurement
EP31JY24.397
§
!
(Outcome)
PatientReported
OutcomeBased
Performance
Measure
Leg Pain After Lumbar
Surgery:
For patients 18 years of
age or older who had a
lumbar
discectomyllaminectomy
or fusion procedure, leg
pain is rated by the patient
as less than or equal to 3.0
OR an improvement of 5 .0
points or greater on the
Visual Analog Scale
(VAS) Pain scale or a
numeric pain scale at three
months (6 to 20 weeks) for
discectomyllaminectomy
or at one year (9 to 15
months) postoperatively
for lumbar fusion patients.
Rates are stratified by
procedure type; lumbar
discectomyllaminectomy
or fusion rocedure.
Functional Status After
Primary Total Knee
Replacement:
For patients age 18 and olde
who had a primary total
knee replacement procedure,
functional status is rated by
the patient as greater than or
equal to 37 on the Oxford
Knee Score (OKS) or a 71 o
greater on the KOOS, JR
tool at one year (9 to 15
months osto erativel .
Functional Status After
Lumbar Surgery:
For patients age 18 and olde
who had lumbar
discectomyllaminectomy or
fusion procedure, functional
status is rated by the patient
as less than or equal to 22
OR an improvement of30
points or greater on the
Oswestry Disability Index
(ODl version 2. la) at three
months (6 to 20 weeks)
postoperatively for
discectomyllaminectomy or
at one year (9 to 15 months)
postoperatively for lumbar
fusion patients. Rates are
stratified by procedure type;
lumbar discectomy or fusion
rocedure.
62440
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B.30. Orthopedic Surgery
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Centers for Medicare &
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EP31JY24.398
§
Functional Status Change
for Patients with Neck
Impairments:
A patient-reported
outcome measure (PROM)
ofrisk-adjusted change in
functional status (FS) for
patients 14 years+ with
neck impairments. The
change in FS is assessed
using the FOTO Neck FS
PROM. The measure is
adjusted to patient
characteristics known to be
associated with FS
outcomes (risk-adjusted)
and used as a performance
measure at the patient,
individual clinician, and
clinic levels to assess
uali
Risk-standardized
complication rate
(RSCR) following elective
primary total hip
arthroplasty (THA)
and/or total knee
arthroplasty (TKA) for
Merit-based Incentive
Payment System (MIPS):
This measure is a respecified version of the
measure, "Hospital-level
Risk-standardized
Complication rate (RSCR)
following Elective Primary
Total Hip Arthroplasty
(THA) and/or Total Knee
Arthroplasty (TKA)"
(National Quality Forum
1550), which was
developed for patients 65
years and older using
Medicare claims. This respecified measure
attributes outcomes to
Merit-based Incentive
Payment System
participating clinicians
and/or clinician groups
("provider") and assesses
each provider's
complication rate, defined
as any one of the specified
complications occurring
from the date of index
admission to up to 90 days
post date of the index
rocedure.
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Screening for Social
Drivers of Health:
Percent of patients 18
years and older screened
for food insecurity,
housing instability,
transportation needs, utility
difficulties, and
interpersonal safety.
Centers for Medicare &
Medicaid Services
Process
Connection to
Community Service
Provider:
Percent of patients 18
years or older who screen
positive for one or more of
the following health related
social needs (HRSNs):
food insecurity, housing
instability, transportation
needs, utility help needs, or
interpersonal safety; and
had contact with a
Community Service
Provider (CSP) for at least
1 of their HRSNs within
60 da s after screenin .
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8.31. Otolaryngology
In addition to the considerations discussed in the introductory language of Table Group B of this Appendix to this proposed rule,
the Otolaryngology specialty set takes additional criteria into consideration, which includes, but is not limited to: whether a
measure reflects current clinical guidelines, and the coding of the measure includes relevant clinician types. We may reassess the
appropriateness of individual measures, on a case-by-case basis, to ensure appropriate inclusion in the specialty set. Measure
tables in this set include previously finalized measures we are maintaining within the set, measures proposed to be added, and
measures proposed for removal, as applicable. We request comment on the measures available in the proposed Otolaryngology
specialty set.
B.31. Otolaryngology
(Care
Coordination)
§
!
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Use)
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BClaims
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Specifications
Process
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Specifications,
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Specifications
Process
NIA
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B Claims
Measure
Specifications,
MIPSCQM
S ecifications
Process
CMS13
8vl3
Medicare Part
BClaims
Measure
Specifications,
eCQM
Specifications,
MIPSCQM
Specifications
Process
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•
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National Committee
for Quality
Assurance
National Committee
for Quality
Assurance
Centers for Medicare
& Medicaid Services
National Committee
for Quality
Assurance
National Committee
for Quality
Assurance
EP31JY24.400
*
Advance Care Plan:
Percentage of patients aged 65
years and older who have an
advance care plan or surrogate
decision maker documented in
the medical record or
documentation in the medical
record that an advance care
plan was discussed but the
patient did not wish or was not
able to name a surrogate
decision maker or provide an
advance care Ian.
Appropriate Testing for
Pharyngitis:
The percentage of episodes for
patients 3 years and older with
a diagnosis of pharyngitis that
resulted in an antibiotic order
on or within 3 days after the
episode date and a group A
Streptococcus (Strep) test in
the seven-day period from
three days prior to the episode
date through three days after
the e isode date.
Documentation of Current
Medications in the Medical
Record:
Percentage of visits for patients
aged 18 years and older for
which the eligible clinician
attests to documenting a list of
current medications using all
immediate resources available
on the date of the encounter.
Falls: Plan of Care:
Percentage of patients aged 65
years and older with a history
of falls who had a plan of care
for falls documented within 12
months.
Preventive Care and
Screening: Tobacco Use:
Screening and Cessation
Intervention:
Percentage of patients aged 12
years and older who were
screened for tobacco use one or
more times during the
measurement period AND who
received tobacco cessation
intervention during the
measurement period or in the
six months prior to the
measurement period if
identified as a tobacco user.
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B.31. Otolaryngology
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Use of High-Risk
Medications in Older Adults:
Percentage of patients 65 years
of age and older who were
ordered at least two high-risk
medications from the same
dru class.
Sleep Apnea: Severity
Assessment at Initial
Diagnosis:
Percentage of patients aged 18
years and older with a
diagnosis of obstructive sleep
apnea who had an apnea
hypopnea index (AID), a
respiratory disturbance index
(RDl), or a respiratory event
index (REI) documented or
measured within 2 months of
initial evaluation for suspected
obstructive slee a nea.
Sleep Apnea: Assessment of
Adherence to Obstructive
Sleep Apnea (OSA) Therapy:
Percentage of patients aged 18
years and older with a
diagnosis of obstructive sleep
apnea (OSA) that were
prescribed an evidence-based
therapy that had documentation
that adherence to therapy was
assessed at least annually
through an objective
informatics system or through
self-reporting (if objective
re rtin is not available .
Preventive Care and
Screening: Screening for
High Blood Pressure and
Follow-Up Documented:
Percentage of patient visits for
patients aged 18 years and
older seen during the
measurement period who were
screened for high blood
pressure AND a recommended
follow-up plan is documented,
as indicated, if blood pressure
is elevated or h ertensive.
Falls: Screening for Future
Fall Risk:
Percentage of patients 65 years
of age and older who were
screened for future fall risk
during the measurement
eriod.
Adult Sinusitis: Antibiotic
Prescribed for Acute Viral
Sinusitis (Overuse):
Percentage of patients, aged 18
years and older, with a
diagnosis of acute viral
sinusitis who were prescribed
an antibiotic within 10 days
after onset of s -m toms.
E:\FR\FM\31JYP2.SGM
31JYP2
National Committee
for Quality
Assurance
American Academy
of Sleep Medicine
American Academy
of Sleep Medicine
Centers for Medicare
& Medicaid Services
National Committee
for Quality Assurance
American Academy
of
OtolaryngologyHead and Neck
Surgery Foundation
EP31JY24.401
*
eCQM
Specifications,
MIPSCQM
Specifications
62444
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8.31. Otolaryngology
(Appropriate
Use)
NIAi
NIA
332
NIAi
NIA
NIA
MIPS CQM
Specifications
Process
355
NIA
MIPS CQM
Specifications
Outcome
NIAi
NIA
357
NIA
MIPS CQM
Specifications
Outcome
NIAi
NIA
358
NIA
MIPS CQM
Specifications
Process
NIAi
NIA
374
CMS50
v13
eCQM
Specifications,
MIPS CQM
Specifications
Process
NIAi
NIA
398
NIA
MIPS CQM
Specifications
Outcome
*
§
!
(Outcome)
!
(Outcome)
!
(Patient
Experience)
*
!
(Care
Coordination)
!
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American
Academy of
OtolaryngologyHead and Neck
Surgery Foundation
American College of
Surgeons
American College
of Surgeons
American
College
of Surgeons
Centers for Medicare
Medicaid Services
Minnesota Community
Measurement
EP31JY24.402
!
Adult Sinusitis: Appropriate
Choice of Antibiotic:
Amoxicillin With or Without
Clavulanate Prescribed for
Patients with Acute Bacterial
Sinusitis (Appropriate Use):
Percentage of patients aged 18
years and older with a
diagnosis of acute bacterial
sinusitis that were prescribed
amoxicillin, with or without
clavulanate, as a first line
antibiotic at the time of
dia nosis.
Unplanned Reoperation
within the 30-Day
Postoperative Period:
Percentage of patients aged 18
years and older who had any
unplanned reoperation within
the 30-day postoperative
eriod.
Surgical Site Infection (SST):
Percentage of patients aged 18
years and older who had a
sur ical site infection SST .
Patient-Centered Surgical Risk
Assessment and
Communication:
Percentage of patients who
underwent a non-emergency
surgery who had their
personalized risks of
postoperative complications
assessed by their surgical team
prior to surgery using a clinical
data-based, patient-specific risk
calculator and who received
personal discussion of those
risks with the sur eon.
Closing the Referral Loop:
Receipt of Specialist Report:
Percentage of patients with
referrals, regardless of age, for
which the referring clinician
receives a report from the
clinician to whom the patient
was referred.
Optimal Asthma Control:
Composite measure of the
percentage of pediatric and adult
patients whose asthma is wellcontrolled as demonstrated by
one of three age appropriate
patient reported outcome tools
and not at risk for exacerbation.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62445
8.31. Otolaryngology
2152 I
NIA
*
0657 I
NIA
!
(Equity)
*
!
(Appropriate
Use)
*
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!
(Equity)
VerDate Sep<11>2014
NIA
MIPS CQM
Specifications
464
NIA
MIPS CQM
Specifications
Process
NIAi
NIA
487
NIA
MIPS CQM
Specifications
Process
3620 I
NIA
493
NIA
MIPS CQM
Specifications
Process
NIAi
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National Committee
for Quality
Assurance
American Academy
ofOtolaryngologyHead and Neck
Surgery Foundation
Centers for Medicare
& Medicaid Services
National Committee
for Quality
Assurance
OCHTN
EP31JY24.403
§
Preventive Care and
Screening: Unhealthy
Alcohol Use: Screening &
Brief Counseling:
Percentage of patients aged 18
years and older who were
screened for unhealthy alcohol
use using a systematic screening
method at least once within the
last 12 months AND who
received brief counseling if
identified as an unhealthy
alcohol user.
Otitis Media with Effusion:
Systemic Antimicrobials Avoidance of Inappropriate
Use:
Percentage of patients aged 2
months through 12 years with a
diagnosis ofOME who were
not prescribed systemic
antimicrobials.
Screening for Social Drivers
of Health: Percent of patients
18 years and older screened for
food insecurity, housing
instability, transportation
needs, utility difficulties, and
inter ersonal safe
Adult Immunization Status:
Percentage of patients 19 years
of age and older who are up-todate on recommended routine
vaccines for influenza; tetanus
and diphtheria (Td) or tetanus,
diphtheria and acellular
pertussis (Tdap); zoster; and
neumococcal.
Connection to Community
Service Provider:
Percent of patients 18 years or
older who screen positive for
one or more of the following
health related social needs
(HRSNs): food insecurity,
housing instability,
transportation needs, utility
help needs, or interpersonal
safety; and had contact with a
Community Service Provider
(CSP) for at least I of their
HRSNs within 60 days after
screenin
62446
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B.31. Otolaryngology
NIAi
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TBD
NIA
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CQM
Specificati
ons
Process
Adult COVID19 Vaccination
Status:
Percentage of
patients aged 18
years and older
seen for a visit
during the
performance
period that are up
to date on their
COVID-19
vaccinations as
defined by CDC
recommendation
son current
vaccination.
Centers for
Medicare
&
Medicaid
Services
We are proposing to include this
measure in the Otolaryngology
specialty set as it would be
clinically relevant to this
clinician type. Widespread
vaccination against SARS-CoV2, the virus that causes COVIDl 9, is critically important to
stemming the morbidity and
mortality caused by this
disease. 117 Clinicians are
uniquely positioned to
encourage uptake of COVID-19
vaccination, and clinicians are
still a ma,jor driving force in
promoting patient vaccination.
The addition of this quality
measure in this specialty set
would help strengthen
compliance with recommended
COVID-19 vaccination, leading
to improvement in the quality of
patient care and prevention of
disease for the general
population. This quality measure
aligns with clinical guidelines
and the evidence-based
recommendations of the ACIP,
where there is general agreement
about the safety and efficacy of
the COVID-19 vaccine,
preventing costly and potentially
harmful hospitalizations. 118
Broadening vaccination status
awareness to this clinician type
is valuable as it can help drive
an increase in the adult
vaccination rates. The COVID19 vaccination included within
this measure would reduce the
prevalence of severe diseases
that may be associated with
hospitalization and decrease
overall health care costs. The
measure being added to this
specialty set would be
contingent on the inclusion of
applicable coding by the time of
the CY 2025 PFS final rule. In
the event appropriate coding is
not included in the fmal
specification, this measure
would not be finalized for
inclusion within this specialty
measure set. See Table A.5 of
this Appendix for rationale,
including clinical evidence
supporting the inclusion of this
measure in MIPS.
117
118
VerDate Sep<11>2014
See footnote lkeokwu et al., 2023 in Table B.l of this Appendix.
See footnotes Fitzpatrick et al., 2022; Polack et al., 2020; and Grana et al., 2022 in Table A.5 of this Appendix.
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B.32. Pathology
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62447
In addition to the considerations discussed in the introductory language of Table Group B of this Appendix to this proposed rule,
the Pathology specialty set takes additional criteria into consideration, which includes, but is not limited to: whether a measure
reflects current clinical guidelines, and the coding of the measure includes relevant clinician types. We may reassess the
appropriateness of individual measures, on a case-by-case basis, to ensure appropriate inclusion in the specialty set. Measure
tables in this set include previously finalized measures we are maintaining within the set, measures proposed to be added, and
measures proposed for removal, as applicable. We request comment on the measures available in the proposed Pathology
specialty set that have proposed substantive changes in Table Group D of this Appendix as indicated by an* in the Indicator
column.
B.32. Pathology
§
!
(Care
Coordination)
!
(Care
Coordination)
!
(Care
Coordination)
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(Care
Coordination)
!
(Care
Coordination)
VerDate Sep<11>2014
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NIA
NIAi
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N/A/
NIA
N/A/
NIA
249
250
395
396
NIA
NIA
Medicare Part
B Claims
Measure
Specifications,
MIPSCQM
Specifications
Process
NIA
Medicare Part
B Claims
Measure
Specifications,
MIPSCQM
Specifications
Process
NIA
Medicare Part
B Claims
Measure
Specifications,
MIPSCQM
Specifications
Process
Process
Process
NIAi
NIA
397
NIA
Medicare Part
B Claims
Measure
Specifications,
MIPSCQM
Specifications
NIAi
NIA
440
NIA
MIPSCQM
Specifications
Process
491
NIA
MIPSCQM
Specifications
Process
3661 /
N/A
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Barrett's Esophagus:
Percentage of esophageal biopsy reports
that document the presence of Barrett's
mucosa that also include a statement
about dysplasia.
Radical Prostatectomy Pathology
Reporting:
Percentage ofradical prostatectomy
pathology reports that include the pT
category, the pN category, the Gleason
score and a statement about margin
status.
Lung Cancer Reporting
(Biopsy/Cytology Specimens):
Pathology reports based on lung biopsy
and/or cytology specimens with a
diagnosis of primary non-small cell lung
cancer classified into specific histologic
type following the International
Association for the Study of Lung
Cancer (IASLC) guidance or classified
as non-small cell lung cancer not
otherwise specified (NSCLC-NOS) with
an explanation included in the pathology
re art.
Lung Cancer Reporting (Resection
Specimens):
Pathology reports based on lung
resection specimens with a diagnosis of
primary lung carcinoma that include the
pT category, pN category and for nonsmall cell lung cancer (NSCLC),
e.
histolo ic
Melanoma Reporting:
Pathology reports for primary malignant
cutaneous melanoma that include the pT
category, thickness, ulceration and
mitotic rate, peripheral and deep margin
status and presence or absence of
microsatellitosis for invasive tumors.
Skin Cancer: Biopsy Reporting Time Pathologist to Clinician:
Percentage of biopsies with a diagnosis
of cutaneous basal cell carcinoma (BCC)
and squamous cell carcinoma ( SCC). or
melanoma (including in situ disease) in
which the pathologist communicates
results to the clinician within 7 days
from the time when the tissue specimen
was received b the atholo ist.
Mismatch Repair (MMR) or
Microsatellite Instability (MST)
Biomarker Testing Status:
Sfmt 4725
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31JYP2
College of
American
Pathologists
College of
American
Pathologists
College of
American
Pathologists
College of
American
Pathologists
College of
American
Pathologists
American
Academy of
Dermatology
College of
American
Pathologists
EP31JY24.405
•
Medicare Part
B Claims
Measure
Specifications,
MIPSCQM
S ecifications
62448
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B.32. Pathology
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Percentage of surgical pathology reports
for primary colorectal, endometrial,
gastroesophageal or small bowel
carcinoma, biopsy or resection, that
contain impression or conclusion of or
recommendation for testing of mismatch
repair (MMR) by immunohistochemistry
(biomarkers MLHI, MSH2, MSH6, and
PMS2), or microsatellite instability
(MSI) by DNA-based testing status, or
both.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62449
B.33. Pediatrics
In addition to the considerations discussed in the introductory language of Table Group B of this Appendix to this proposed rule,
the Pediatrics specialty set takes additional criteria into consideration, which includes, but is not limited to: whether a measure
reflects current clinical guidelines, and the coding of the measure includes relevant clinician types. We may reassess the
appropriateness of individual measures, on a case-by-case basis, to ensure appropriate inclusion in the specialty set. Measure
tables in this set include previously finalized measures we are maintaining within the set, measures proposed to be added, and
measures proposed for removal, as applicable. We request comment on the measures available in the proposed Pediatrics
specialty set that have proposed substantive changes in Table Group D of this Appendix as indicated by an* in the Indicator
column.
B.33. Pediatrics
.·
PREVIOUSLV FINALIZED MEASURES IN THE PEDIATRIC$ SPECIALTY SET
.·
Qulllity
#
CMS
eCQM
lD
065
eCQM
Specifications,
MIPS CQM
Specifications
Process
NIAi
NIA
066
CMS14
6v13
eCQM
Specifications,
MIPS CQM
Specifications
Process
0058 I
NIA
116
NIA
MIPS CQM
Specifications
Process
CMS2v
14
Medicare Part
B Claims
Measure
Specifications,
eCQM
Specifications,
MIPS CQM
Specifications
Process
0069 I
NIA
§
!
(Appropriate
Use)
§
!
(Appropriate
Use)
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§
VerDate Sep<11>2014
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Type
CMS15
4v13
§
!
(Appropriate
Use)
Collection
Type
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Measure Title
and Description
Appropriate Treatment for
Upper Respiratory Infection
(l!Rl):
Percentage of episodes for
patients 3 months of age and
older with a diagnosis of upper
respiratory infection ( URl) that
did not result in an antibiotic
order.
Appropriate Testing for
Pharyngitis:
The percentage of episodes for
patients 3 years and older with
a diagnosis of pharyngitis that
resulted in an antibiotic order
on or within 3 days after the
episode date and a group A
Streptococcus (Strep) test in
the seven-day period from
three days prior to the episode
date through three days after
the episode date.
Avoidance of Antibiotic
Treatment for Acute
Bronchitis/Bronchiolitis:
The percentage of episodes for
patients ages 3 months and
older with a diagnosis of acute
bronchitis/bronchiolitis that did
not result in an antibiotic
dispensing event.
Preventive Care and
Screening: Screening for
Depression and Follow-Up
Plan:
Percentage of patients aged 12
years and older screened for
depression on the date of the
encounter or up to 14 days
prior to the date of the
encounter using an ageappropriate standardized
depression screening tool AND
if positive, a follow-up plan is
documented on the date ofor
up to two days after the date of
the qualifying encounter.
E:\FR\FM\31JYP2.SGM
31JYP2
Meas.ure. Steward
National Committee
for Quality Assurance
National Committee
for Quality Assurance
National Committee
for Quality Assurance
Centers for Medicare
& Medicaid Services
EP31JY24.407
Indicator
CBE#
I
eCQM
C:BE#
62450
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
B.33. Pediatrics
§
§
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VerDate Sep<11>2014
205
CMSII
88v2
eCQM
Specifications,
MIPSCQM
Specifications
Process
Medicare Part
BClaims
Measure
Specifications,
eCQM
Specifications,
MIPSCQM
Specifications
Process
NIAi
NIA
226
CMSl3
8vl3
NIAi
NIA
239
CMSIS
5v13
NIAi
NIA
240
CMSII
7v13
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Specifications
eCQM
Specifications
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Health Resources and
Services
Administration
National Committee
for Quality Assurance
National Committee
for Quality Assurance
National Committee
for Quality Assurance
EP31JY24.408
§
NIAi
NIA
Sexually Transmitted
Infection (STI) Testing for
People with HIV:
Percentage of patients 13 years
of age and older with a
diagnosis of HIV who had tests
for syphilis, gonorrhea, and
chlamydia performed within
the rformance eriod.
Preventive Care and
Screening: Tobacco Use:
Screening and Cessation
Intervention: Percentage of
patients aged 12 years and
older who were screened for
tobacco use one or more times
during the measurement period
AND who received tobacco
cessation intervention during
the measurement period or in
the six: months prior to the
measurement period if
identified as a tobacco user.
Weight Assessment and
Counseling for Nutrition and
Physical Activity for
Children/Adolescents:
Percentage of patients 3-17
years of age who had an
outpatient visit with a Primary
Care Physician (PCP) or
Obstetrician/Gynecologist
(OB/GYN) and who had
evidence of the following
during the measurement
period.
• Percentage of patients with
height, weight, and body mass
index: (BMI) percentile
documentation.
• Percentage of patients with
counseling for nutrition.
• Percentage of patients with
counseling for physical
activi
Childhood Immunization
Status:
Percentage ofchildren 2 years
of age who had four diphtheria,
tetanus and acellular pertussis
(DtaP); three polio ()PY), one
measles, mumps and rubella
(MMR); three or four H
influenza type B (Hib ); three
hepatitis B (HepB); one
chicken pox (VZV); four
pneumococcal conjugate
(PCV); one hepatitis A
(HepA); two or three rotavirus
(RV); and two influenza (flu)
vaccines by their second
birthdav.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62451
B.33. Pediatrics
305
CMS13
7v13
eCQM
Specifications
Process
NIAi
NIA
310
CMSl5
3v\3
eCQM
Specifications
Process
§
NIAi
NIA
366
CMS13
6vl4
eCQM
Specifications
Process
§
!
(Outcome)
07101
0710e
CMS15
9v13
eCQM
Specifications,
MIPSCQM
Specifications
Outcome
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National Committee
for Quality Assurance
National Committee
for Quality Assurance
National Committee
for Quality Assurance
Minnesota Community
Measurement
EP31JY24.409
NIAi
NIA
!
(Opioid)
Initiation and Engagement of
Substance Use Disorder
Treatment:
Percentage of patients 13 years
of age and older with a new
substance use disorder (SUD)
episode who received the
following (Two rates are
reported):
a. Percentage of patients who
initiated treatment, including
either an intervention or
medication for the treatment of
SUD, within 14 days of the
new SUD episode.
b. Percentage of patients who
engaged in ongoing treatment,
including two additional
interventions or medication
treatment events for SUD, or
one long-acting medication
event for the treatment of SUD,
within 34 da s of the initiation.
Chlamydia Screening in
Women:
Percentage of women 16-24
years of age who were
identified as sexually active
and who had at least one test
for chlamydia during the
measurement eriod.
Follow-Up Care for Children
Prescribed ADHD
Medication (ADD):
Percentage of children 6-12
years of age and newly
prescribed a medication for
attention-deficit/hyperactivity
disorder (ADHD) who had
appropriate follow-up care.
Two rates are reported.
(a) Percentage of children who
had one follow-up visit with a
practitioner with prescribing
authority during the 30-Day
Initiation Phase.
(b) Percentage of children who
remained on ADHI)
medication for at least 210
days and who, in addition to
the visit in the Initiation Phase,
had at least two additional
follow-up visits with a
practitioner within 270 days (9
months) after the Initiation
Phase ended.
Depression Remission at
Twelve Months:
The percentage of adolescent
patients 12 to 17 years of age
and adult patients 18 years of
age or older with major
depression or dysthymia who
reached remission 12 months
(+I- 60 days) after an index
event date.
62452
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
B.33. Pediatrics
Child and Adolescent Major
Depressive Disorder (MOD):
Suicide Risk Assessment:
!
(Patient
Safety)
NIA I
NIA
382
CMS17
7vl3
eCQM
Specifications
Process
Percentage of patient visits for
those patients aged 6 through
16 years at the start of the
measurement period with a
diagnosis of major depressive
disorder (MOD) with an
assessment for suicide risk.
Mathematica
Immunizations for
Adolescents:
§
NIA I
NIA
394
NIA
MIPSCQM
Specifications
Process
The percentage of adolescents
13 years of age who had one
dose of meningococcal vaccine
(serogroups A, C, W, Y), one
tetanus, diphtheria toxoids and
acellular pertussis (Tdap)
vaccine, and have completed
the Human Papillomavirus
(HPV) vaccine series by their
13 th birthda .
National Committee
for Quality Assurance
Optimal Asthma Control:
!
(Outcome)
*
!
(Appropriate
Use)
NIAi
NIA
0657
I
NIA
398
464
NIA
NIA
MIPSCQM
Specifications
MIPSCQM
Specifications
Outcome
Composite measure of the
percentage of pediatric and
adult patients whose asthma is
well-controlled as
demonstrated by one of three
age appropriate patient
reported outcome tools and not
at risk for exacerbation.
Otitis Media with Effusion:
Systemic Antimicrobials Avoidance of Inappropriate
Use:
Process
Percentage of patients aged 2
months through 12 years with a
diagnosis ofOME who were
not prescribed systemic
antimicrobials.
Minnesota Community
Measurement
American Academy of
Otolaryngology Head and Neck
Surgery Foundation
Screening for Social Drivers
of Health:
!
(Equity)
NIAi
NIA
487
NIA
MIPSCQM
Specifications
Process
Percent of patients 18 years
and older screened for food
insecurity, housing instability,
transportation needs, utility
difficulties, and interpersonal
safe
Centers for Medicare
& Medicaid Services
Connection to Community
Service Provider:
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31JYP2
OCHIN
EP31JY24.410
*
Percent of patients 18 years or
older who screen positive for
one or more of the following
health related social needs
(HRSNs): food insecurity,
housing instability,
transportation needs, utility
help needs, or interpersonal
safety; and had contact with a
Community Service Provider
(CSP) for at least 1 of their
HRSNs within 60 days after
screenin .
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62453
B.34. Physical Medicine
In addition to the considerations discussed in the introductory language of Table Group B of this Appendix to this proposed rule,
the Physical Medicine specialty set takes additional criteria into consideration, which includes, but is not limited to: whether a
measure reflects current clinical guidelines, and the coding of the measure includes relevant clinician types. We may reassess the
appropriateness of individual measures, on a case-by-case basis, to ensure appropriate inclusion in the specialty set. Measure
tables in this set include previously finalized measures we are maintaining within the set, measures proposed to be added, and
measures proposed for removal, as applicable. We request comment on the measures available in the proposed Physical Medicine
specialty set that have proposed substantive changes in Table Group D of this Appendix as indicated by an* in the Indicator
column.
B.34. Physical Medicine
*
!
(Care
Coordination)
*
§
!
(Patient
Safety)
*
!
(Care
Coordination)
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!
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Indicator
PQEVIOL!SLY FINALIZED MEA.Sl/RESIN THE PHYSICAL MEDICINE SPECIALTY SET
..
CBE#
CMS
f
Quality
Measure
Measure Title
Collection
eCQM
Measure Steward
eCQM
Type
Type
and Description
#
ID
CBE#
Advance Care Plan:
Percentage of patients aged 65
years and older who have an
advance care plan or surrogate
Medicare Part
decision maker documented in
B Claims
the medical record or
Measure
National Committee for
0326 I
047
NIA
Process
documentation in the medical
Specifications,
Quality Assurance
NIA
record that an advance care
MIPS CQM
plan was discussed but the
Specifications
patient did not wish or was
not able to name a surrogate
decision maker or provide an
advance care plan.
Documentation of Current
Medications in the Medical
Record:
Percentage of visits for
eCQM
patients aged 18 years and
NIAi
CMS
Specifications,
Centers for Medicare &
130
Process
older for which the eligible
MIPS CQM
NIA
68v14
Medicaid Services
clinician attests to
Specifications
documenting a list of current
medications using all
immediate resources available
on the date of the encounter.
Medicare Part
Falls: Plan of Care:
B Claims
Percentage of patients aged 65
Measure
years and older with a history
National Committee for
0101 I
155
NIA
Process
Specifications,
Quality Assurance
NIA
of falls who had a plan of care
MIPS CQM
for falls documented within
12 months.
Specifications
Functional Outcome
Assessment:
Percentage of visits for
patients aged 18 years and
older with documentation of a
current functional outcome
assessment using a
NIAi
MIPS CQM
standardized functional
Centers for Medicare &
182
NIA
Process
NIA
Specifications
outcome assessment tool on
Medicaid Services
the date of the encounter
AND documentation of a care
plan based on identified
functional outcome
deficiencies within two days
of the date of the identified
deficiencies.
62454
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
8.34. Physical Medicine
CMS
138vl
3
CMS
22v13
Process
Medicare Part
BClaims
Measure
Specifications,
eCQM
Specifications,
MIPSCQM
Specifications
Process
NIAi
NIA
317
*
!
NIAi
NIA
374
CMS
50v13
eCQM
Specifications,
MIPSCQM
Specifications
Process
21521
NIA
431
NIA
MIPSCQM
Specifications
Process
NIAi
NIA
468
NIA
MIPSCQM
Specifications
Process
NIAi
NIA
487
NIA
MlPSCQM
Specifications
Process
§
!
(Opioid)
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*
(Care
Coordination)
!
(Equity)
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National Committee for
Quality Assurance
Centers for Medicare &
Medicaid Services
Centers for Medicare &
Medicaid Services
National Committee for
Quality Assurance
University of Southern
California
Centers for Medicare &
Medicaid Services
EP31JY24.412
§
Medicare Part
BClaims
Measure
Specifications,
eCQM
Specifications,
MlPSCQM
Specifications
Preventive Care and
Screening: Tobacco Use:
Screening and Cessation
Intervention:
Percentage of patients aged 12
years and older who were
screened for tobacco use one
or more times during the
measurement period AND
who received tobacco
cessation intervention during
the measurement period or in
the six months prior to the
measurement period if
identified as a tobacco user.
Preventive Care and
Screening: Screening for
High Blood Pressure and
Follow-Up Documented:
Percentage of patient visits for
patients aged 18 years and
older seen during the
measurement period who
were screened for high blood
pressure AND a
recommended follow-up plan
is documented, as indicated, if
blood pressure is elevated or
h ertensive.
Closing the Referral Loop:
Receipt of Specialist Report:
Percentage of patients with
referrals, regardless of age, for
which the referring clinician
receives a report ft-om the
clinician to whom the patient
was referred.
Preventive Care and
Screening: Unhealthy
Alcohol Use: Screening &
Brief Counseling:
Percentage of patients aged 18
years and older who were
screened for unhealthy
alcohol use using a systematic
screening method at least once
within the last 12 months
AND who received brief
counseling if identified as an
unhealth alcohol user.
Continuity of
Pharmacotherapy for
Opioid Use Disorder (OUD):
Percentage ofadults aged 18
years and older with
pharmacotherapy for opioid
use disorder (OUD) who have
at least 180 days of
continuous treatment.
Screening for Social Drivers
of Health:
Percent of patients 18 years
and older screened for food
insecurity, housing instability,
transportation needs, utility
difficulties, and interpersonal
safi
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62455
B.34. Physical Medicine
PREVIOUSLY FINAL
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EP31JY24.413
*
Connection to Community
Service Provider:
Percent of patients 18 years or
older who screen positive for
one or more of the following
health related social needs
(HRSNs): food insecurity,
housing instability,
transportation needs, utility
help needs, or interpersonal
safety; and had contact with a
Community Service Provider
(CSP) for at least I of their
HRSNs within 60 days after
screenin .
62456
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
8.35. Physical Therapy/Occupational Therapy
In addition to the considerations discussed in the introductory language of Table Group B of this Appendix to this proposed rule,
the Physical Therapy/Occupational Therapy specialty set takes additional criteria into consideration, which includes, but is not
limited to: whether a measure reflects current clinical guidelines, and the coding of the measure includes relevant clinician types.
We may reassess the appropriateness of individual measures, on a case-by-case basis, to ensure appropriate inclusion in the
specialty set. Measure tables in this set include previously finalized measures we are maintaining within the set, measures
proposed to be added, and measures proposed for removal, as applicable. We request comment on the measures available in the
proposed Physical Therapy/Occupational Therapy specialty set that have proposed substantive changes in Table Group D of this
Appendix as indicated by an * in the Indicator column.
B.35. Physical Therapy/Occupational Therapy
(Patient
Experience)
*
§
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NIA
MIPSCQM
Specifications
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NIAi
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126
NIA
MIPSCQM
Specifications
Process
NIAi
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127
NIA
MIPSCQM
Specifications
Process
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National
Committee for
Quality Assurance
National
Committee for
Quality Assurance
American Podiatric
Medical
Association
American Podiatric
Medical
Association
Centers for
Medicare &
Medicaid Services
EP31JY24.414
!
NIAi
NIA
Urinary Incontinence:
Assessment of Presence or
Absence of Urinary
Incontinence in Women
Aged 65 Years and Older:
Percentage of female patients
aged 65 years and older who
were assessed for the presence
or absence of urinary
incontinence within 12
months.
Urinary Incontinence: Plan
of Care for Urinary
Incontinence in Women
Aged 65 Years and Older:
Percentage of female patients
aged 65 years and older with a
diagnosis of urinary
incontinence with a
documented plan of care for
urinary incontinence at least
once within 12 months.
Diabetes Mellitus: Diabetic
Foot and Ankle Care,
Peripheral Neuropathy Neurological Evaluation:
Percentage of patients aged 18
years and older with a
diagnosis of diabetes mellitus
who had a neurological
examination of their lower
extremities within 12 months.
Diabetes Mellitus: Diabetic
Foot and Ankle Care, Ulcer
Prevention - Evaluation of
Footwear:
Percentage of patients aged 18
years and older with a
diagnosis of diabetes mellitus
who were evaluated for proper
footwear and sizin .
Documentation of Current
Medications in the Medical
Record:
Percentage of visits for
patients aged I 8 years and
older for which the eligible
clinician attests to
documenting a list of current
medications using all
immediate resources available
on the date of the encounter.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62457
B.35. Physical Therapy/Occupational Therapy
*
!
(Care
Coordination)
*
!
(Patient
Safety)
NIAi
NIA
0101 I
NIA
134
155
CMS2v
14
Process
NIA
Medicare Part
B Claims
Measure
Specifications,
MIPS CQM
S ecifications
Process
Process
Process
NIAi
NIA
181
NIA
Medicare Part
B Claims
Measure
Specifications,
MIPS CQM
Specifications
NIAi
NIA
182
NIA
MIPS CQM
Specifications
*
§
!
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Centers for
Medicare &
Medicaid Services
National
Committee for
Quality Assurance
Centers for
Medicare &
Medicaid Services
Centers for
Medicare &
Medicaid Services
EP31JY24.415
§
Medicare Part
B Claims
Measure
Specifications,
eCQM
Specifications,
MIPS CQM
Specifications
Preventive Care and
Screening: Screening for
Depression and Follow-Up
Plan:
Percentage of patients aged 12
years and older screened for
depression on the date of the
encounter or up to 14 days
prior to the date of the
encounter using an ageappropriate standardized
depression screening tool
AND if positive, a follow-up
plan is documented on the
date of or up to two days after
the date of the qualifying
encounter.
Falls: Plan of Care:
Percentage of patients aged 65
years and older with a history
of falls who had a plan of care
for falls documented within
12 months.
Elder Maltreatment Screen
and Follow-Up Plan:
Percentage of patients aged 60
years and older with a
documented elder
maltreatment screen using an
Elder Maltreatment Screening
tool on the date of encounter
AND a documented follow-up
plan on the date of the
ositive screen.
Functional Outcome
Assessment:
Percentage of visits for
patients aged 18 years and
older with documentation of a
current functional outcome
assessment using a
standardized functional
outcome assessment tool on
the date of the encounter AND
documentation of a care plan
based on identified functional
outcome deficiencies within
two days of the date of the
identified deficiencies.
62458
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
B.35. Physical Therapy/Occupational Therapy
(Outcome)
!
(Outcome)
!
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PatientReported
OutcomeBased
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Measure
MIPS CQM
Specifications
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OutcomeBased
Performance
Measure
MIPS CQM
Specifications
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OutcomeBased
Performance
Measure
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Focus on
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Outcomes, Inc.
Focus on
Therapeutic
Outcomes, Inc.
Focus on
Therapeutic
Outcomes, Inc.
EP31JY24.416
!
Functional Status Change
for Patients with Knee
Impairments:
A patient-reported outcome
measure (PROM) of riskadjusted change in functional
status (FS) for patients 14
years+ with knee
impairments. The change in
FS is assessed using the
FOTO Lower Extremity
Physical Function (LEPF)
PROM. The measure is
adjusted to patient
characteristics known to be
associated with FS outcomes
(risk-adjusted) and used as a
performance measure at the
patient, individual clinician,
and clinic levels to assess
uali
Functional Status Change
for Patients with Hip
Impairments:
A patient-reported outcome
measure (PROM) of riskadjusted change in functional
status (FS) for patients 14
years+ with hip impairments.
The change in FS is assessed
using the FOTO Lower
Extremity Physical Function
(LEPF) PROM. The measure
is adjusted to patient
characteristics known to be
associated with FS outcomes
(risk adjusted) and used as a
performance measure at the
patient, individual clinician,
and clinic levels to assess
ualit .
Functional Status Change
for Patients with Lower Leg,
Foot or Ankle Impairments:
A patient-reported outcome
measure (PROM) of riskadjusted change in functional
status (FS) for patients 14
years+ with foot, ankle or
lower leg impairments. The
change in FS is assessed using
the FOTO Lower Extremity
Physical Function (LEPF)
PROM. The measure is
adjusted to patient
characteristics known to be
associated with FS outcomes
(risk-adjusted) and used as a
performance measure at the
patient, individual clinician,
and clinic levels to assess
uali
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
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B.35. Physical Therapy/Occupational Therapy
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!
(Outcome)
!
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MIPS CQM
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OutcomeBased
Performance
Measure
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OutcomeBased
Performance
Measure
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Focus on
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Outcomes, Inc.
Focus on
Therapeutic
Outcomes, Inc.
Focus on
Therapeutic
Outcomes, Inc.
EP31JY24.417
!
Functional Status Change
for Patients with Low Back
Impairments:
A patient-reported outcome
measure (PROM) of riskadjusted change in functional
status (FS) for patients 14
years+ with low back
impairments. The change in
FS is assessed using the
FOTO Low Back FS PROM.
The measure is adjusted to
patient characteristics known
to be associated with FS
outcomes (risk adjusted) and
used as a performance
measure at the patient,
individual clinician, and clinic
levels to assess uali
Functional Status Change
for Patients with Shoulder
Impairments:
A patient-reported outcome
measure (PROM) of riskadjusted change in functional
status (FS) for patients 14
years+ with shoulder
impairments. The change in
FS is assessed using the
FOTO Shoulder FS PROM.
The measure is adjusted to
patient characteristics known
to be associated with FS
outcomes (risk adjusted) and
used as a performance
measure at the patient,
individual clinician, and clinic
levels to assess ualit .
Functional Status Change
for Patients with Elbow,
Wrist or Hand
Impairments:
A patient-reported outcome
measure (PROM) of riskadjusted change in functional
status (FS) for patients 14
years+ with elbow, wrist, or
hand impairments. The
change in FS is assessed using
the FOTO Elbow/Wrist/Hand
FS PROM. The measure is
adjusted to patient
characteristics known to be
associated with FS outcomes
(risk adjusted) and used as a
performance measure at the
patient, individual clinician,
and clinic levels to assess
uali
62460
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B.35. Physical Therapy/Occupational Therapy
*
NIAi
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9vl3
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Specifications
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Specifications
Process
Process
Process
Process
*
!
(Patient
Safety)
*
!
(Care
Coordination)
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National
Committee for
Quality Assurance
American Academy
of Neurology
American
Psychiatric
Association/
American Academy
of Neurology
American Academy
of Neurology I
American
Psychiatric
Association
American Academy
ofNeurology
EP31JY24.418
§
Medicare Part
BClaims
Measure
Specifications,
eCQM
Specifications,
MIPSCQM
Specifications
Preventive Care and
Screening: Tobacco Use:
Screening and Cessation
Intervention: Percentage of
patients aged 12 years and
older who were screened for
tobacco use one or more times
during the measurement
period AND who received
tobacco cessation intervention
during the measurement
period or in the six months
prior to the measurement
period if identified as a
tobacco user.
Dementia: Cognitive
Assessment: Percentage of
patients, regardless of age,
with a diagnosis of dementia
for whom an assessment of
cognition is performed and the
results reviewed at least once
within a 12-month eriod.
Dementia: Safety Concern
Screening and Follow-Up
for Patients with Dementia:
Percentage of patients with
dementia or their caregiver(s)
for whom there was a
documented safety concerns
screening in two domains of
risk: (I) dangerousness to self
or others and (2)
environmental risks; and if
safety concerns screening was
positive in the last 12 months,
there was documentation of
mitigation recommendations,
including but not limited to
referral to other resources.
Dementia: Education and
Support of Caregivers for
Patients with Dementia:
Percentage of patients with
dementia whose caregiver(s)
were provided with education
on dementia disease
management and health
behavior changes AND were
referred to additional
resources for support in the
last 12 months.
Assessment of Cognitive
Impairment or Dysfunction
for Patients with
Parkinson's Disease:
Percentage of all patients with
a diagnosis of Parkinson's
Disease (PD) who were
assessed for cognitive
impairment or dysfunction
once during the measurement
riod.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62461
8.35. Physical Therapy/Occupational Therapy
§
!
(Outcome)
!
(Equity)
*
(Equity)
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Specifications
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Performance
Measure
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478
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Specifications
Process
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National
Committee for
Quality Assurance
Focus on
Therapeutic
Outcomes, Inc.
Centers for
Medicare&
Medicaid Services
OCHIN
American
Psychiatric
Association
EP31JY24.419
!
(Patient
Safety)
Falls: Screening for Future
Fall Risk:
Percentage of patients 65
years of age and older who
were screened for future fall
risk during the measurement
eriod.
Functional Status Change
for Patients with Neck
Impairments:
A patient-reported outcome
measure (PROM) ofriskadjusted change in functional
status (FS) for patients 14
years+ with neck
impairments. The change in
FS is assessed using the
POTO Neck FS PROM. The
measure is adjusted to patient
characteristics known to be
associated with FS outcomes
(risk-adjusted) and used as a
performance measure at the
patient, individual clinician,
and clinic levels to assess
uali
Screening for Social Drivers
of Health:
Percent of patients 18 years
and older screened for food
insecurity, housing instability,
transportation needs, utility
difficulties, and interpersonal
safe
Connection to Community
Service Provider:
Percent of patients 18 years or
older who screen positive for
one or more of the following
health related social needs
(HRSNs): food insecurity,
housing instability,
transportation needs, utility
help needs, or interpersonal
safety; and had contact with a
Community Service Provider
(CSP) for at least 1 of their
HRSNs within 60 days after
screenin .
Improvement or
Maintenance of Functioning
for Individuals with a
Mental and/or Substance
Use Disorder:
The percentage of patients
aged 18 and older with a
mental and/or substance use
disorder who demonstrated
improvement or maintenance
offunctioning based on
results from the 12-item
World Health Organization
Disability Assessment
Schedule (WHODAS 2.0) or
Sheehan Disability Scale
(SDS) 30 to 180 days after an
index assessment.
62462
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
B.35. Physical Therapy/Occupational Therapy
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Insignia Health,
LLC, a wholly
owned subsidiary
of Phreesia
EP31JY24.420
*
PatientReported
OutcomeBased
Performance
Measure
Gains in Patient Activation
Measure (PAM®) Scores at
12 Months:
The Patient Activation
Measure® (PAM®) is a 10or 13 - item questionnaire that
assesses an individual's
knowledge, skills and
confidence for managing their
health and health care. The
measure assesses individuals
on a 0-100 scale that converts
to one of four levels of
activation, from low (I) to
high (4). The PAM®
performance measure
(PAM®-PM) is the change in
score on the PAM® from
baseline to follow-up
measurement.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62463
B.36. Plastic Surgery
In addition to the considerations discussed in the introductory language of Table Group B of this Appendix to this proposed rule,
the Plastic Surgery specialty set takes additional criteria into consideration, which includes, but is not limited to: whether a
measure reflects current clinical guidelines, and the coding of the measure includes relevant clinician types. We may reassess the
appropriateness of individual measures, on a case-by-case basis, to ensure appropriate inclusion in the specialty set. Measure
tables in this set include previously finalized measures we are maintaining within the set, measures proposed to be added, and
measures proposed for removal, as applicable. We request comment on the measures available in the proposed Plastic Surgery
specialty set that have proposed substantive changes in Table Group D of this Appendix as indicated by an* in the Indicator
column.
8.36. Plastic Surgery
§
!
(Patient
Safety)
NIAi
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*
*
§
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317
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B Claims
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Centers for Medicare &
Medicaid Services
National Committee for
Quality Assurance
Centers for Medicare &
Medicaid Services
American College of
Surgeons
EP31JY24.421
*
Documentation of Current
Medications in the Medical
Record:
Percentage of visits for
patients aged 18 years and
older for which the eligible
clinician attests to
documenting a list of current
medications using all
immediate resources
available on the date of the
encounter.
Preventive Care and
Screening: Tobacco Use:
Screening and Cessation
Intervention:
Percentage of patients aged
12 years and older who were
screened for tobacco use one
or more times during the
measurement period AND
who received tobacco
cessation intervention during
the measurement period or in
the six months prior to the
measurement period if
identified as a tobacco user.
Preventive Care and
Screening: Screening for
High Blood Pressure and
Follow-lip Documented:
Percentage of patient visits
for patients aged 18 years and
older seen during the
measurement period who
were screened for high blood
pressure AND a
recommended follow-up plan
is documented, as indicated,
if blood pressure is elevated
or hypertensive.
Unplanned Reoperation
within the 30-Day
Postoperative Period:
Percentage of patients aged
18 years and older who had
any unplanned reoperation
within the 30-day
osto erative eriod.
62464
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
8.36. Plastic Surgery
!
(Outcome)
!
(Patient
Experience)
!
(Equity)
*
!
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American College of
Surgeons
American College of
Surgeons
American College of
Surgeons
Centers for Medicare &
Medicaid Services
OCHIN
EP31JY24.422
!
(Outcome)
Unplanned Hospital
Readmission within 30
Days of Principal
Procedure:
Percentage of patients aged
18 years and older who had
an unplanned hospital
readmission within 30 days
of rinci al rocedure.
Surgical Site Infection
(SST):
Percentage of patients aged
18 years and older who had a
sur ical site infection SST .
Patient-Centered Surgical
Risk Assessment and
Communication: Percentage
of patients who underwent a
non-emergency surgery who
had their personalized risks
of postoperative
complications assessed by
their surgical team prior to
surgery using a clinical databased, patient-specific risk
calculator and who received
personal discussion of those
risks with the sur eon.
Screening for Social
Drivers of Health:
Percent of patients 18 years
and older screened for food
insecurity, housing
instability, transportation
needs, utility difficulties, and
inter ersonal safet .
Connection to Community
Service Provider:
Percent of patients 18 years
or older who screen positive
for one or more of the
following health related
social needs (HRSNs): food
insecurity, housing
instability, transportation
needs, utility help needs, or
interpersonal safety; and had
contact with a Community
Service Provider (CSP) for at
least 1 of their HRSN s within
60 da s after screenin
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62465
B.37. Podiatry
In addition to the considerations discussed in the introductory language of Table Group B of this Appendix to this proposed rule,
the Podiatry specialty set takes additional criteria into consideration, which includes, but is not limited to: whether a measure
reflects current clinical guidelines, and the coding of the measure includes relevant clinician types. We may reassess the
appropriateness of individual measures, on a case-by-case basis, to ensure appropriate inclusion in the specialty set. Measure
tables in this set include previously finalized measures we are maintaining within the set, measures proposed to be added, and
measures proposed for removal, as applicable. We request comment on the measures available in the proposed Podiatry specialty
set that have proposed substantive changes in Table Group D of this Appendix as indicated by an * in the Indicator column.
B.37. Podiatry
126
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B Claims
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Specifications,
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Process
MIPS CQM
Specifications
PatientReported
OutcomeBased
Performanc
e Measure
*
!
0101
(Care
Coordination)
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American Podiatric
Medical Association
American Podiatric
Medical Association
National Committee
for Quality Assurance
Focus on Therapeutic
Outcomes, Inc.
EP31JY24.423
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Diabetes Mellitus: Diabetic
Foot and Ankle Care,
Peripheral NeuropathyNeurological Evaluation:
Percentage of patients aged 18
years and older with a
diagnosis of diabetes mellitus
who had a neurological
examination of their lower
extremities within 12 months.
Diabetes Mellitus: Diabetic
Foot and Ankle Care, Ulcer
Prevention - Evaluation of
Footwear:
Percentage of patients aged 18
years and older with a
diagnosis of diabetes mellitus
who were evaluated for proper
footwear and sizin .
Falls: Plan of Care:
Percentage of patients aged 65
years and older with a history
of falls who had a plan of care
for falls documented within 12
months.
Functional Status Change
for Patients with Lower Leg,
Foot or Ankle Impairments:
A patient-reported outcome
measure (PROM) of riskadjusted change in functional
status (FS) for patients 14
years+ with foot, ankle or
lower leg impairments. The
change in FS is assessed using
the FOTO Lower Extremity
Physical Function (LEPF)
PROM. The measure is
adjusted to patient
characteristics known to be
associated with FS outcomes
(risk-adjusted) and used as a
performance measure at the
patient, individual clinician,
and clinic levels to assess
uali
62466
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
B.37. Podiatry
*
!
(Patient
Safety)
!
(Patient
Experience)
!
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138vl
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B Claims
Measure
Specifications,
eCQM
Specifications,
MIPS CQM
Specifications
Process
317
CMS
22v13
318
CMS
139vl
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Specifications
Process
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National Committee
for Quality Assurance
Centers for Medicare &
Medicaid Services
National Committee
for Quality Assurance
American College of
Surgeons
Centers for Medicare &
Medicaid Services
EP31JY24.424
§
Medicare Part
B Claims
Measure
Specifications,
eCQM
Specifications,
MIPS CQM
Specifications
Preventive Care and
Screening: Tobacco Use:
Screening and Cessation
Intervention:
Percentage of patients aged 12
years and older who were
screened for tobacco use one
or more times during the
measurement period AND
who received tobacco
cessation intervention during
the measurement period or in
the six months prior to the
measurement period if
identified as a tobacco user.
Preventive Care and
Screening: Screening for
High Blood Pressure and
Follow-Up Documented:
Percentage of patient visits for
patients aged 18 years and
older seen during the
measurement period who were
screened for high blood
pressure AND a recommended
follow-up plan is documented,
as indicated, if blood pressure
is elevated or h ertensive.
Falls: Screening for Future
Fall Risk:
Percentage of patients 65 years
of age and older who were
screened for future fall risk
during the measurement
eriod.
Patient-Centered Surgical
Risk Assessment and
Communication:
Percentage of patients who
underwent a non-emergency
surgery who had their
personalized risks of
postoperative complications
assessed by their surgical team
prior to surgery using a
clinical data-based, patientspecific risk calculator and
who received personal
discussion of those risks with
the sur eon.
Screening for Social Drivers
of Health:
Percent of patients 18 years
and older screened for food
insecurity, housing instability,
transportation needs, utility
difficulties, and interpersonal
safe
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62467
B.37. Podiatry
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PatientReported
OutcomeBased
Performan
ce
Measure
Sfmt 4725
E:\FR\FM\31JYP2.SGM
31JYP2
OCHIN
Insignia Health, LLC, a
wholly owned
subsidiary of Phreesia
EP31JY24.425
*
!
(Equity)
Connection to Community
Service Provider:
Percent of patients 18 years or
older who screen positive for
one or more of the following
health related social needs
(HRSNs): food insecurity,
housing instability,
transportation needs, utility
help needs, or interpersonal
safety; and had contact with a
Community Service Provider
(CSP) for at least 1 of their
HRSNs within 60 days after
screenin .
Gains in Patient Activation
Measure (PAM®) Scores at
12 Months:
The Patient Activation
Measure® (PAM®) is a 10or 13 - item questionnaire that
assesses an individual's
knowledge, skills and
confidence for managing their
health and health care. The
measure assesses individuals
on a 0-100 scale that converts
to one of four levels of
activation, from low (I) to
high (4). The PAM®
performance measure (PAM®PM) is the change in score on
the PAM® from baseline to
follow-u measurement.
62468
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
B.38. Preventive Medicine
In addition to the considerations discussed in the introductory language of Table Group B of this Appendix to this proposed rule,
the Preventive Medicine specialty set takes additional criteria into consideration, which includes, but is not limited to: whether a
measure reflects current clinical guidelines, and the coding of the measure includes relevant clinician types. We may reassess the
appropriateness of individual measures, on a case-by-case basis, to ensure appropriate inclusion in the specialty set. Measure
tables in this set include previously finalized measures we are maintaining within the set, measures proposed to be added, and
measures proposed for removal, as applicable. We request comment on the measures available in the proposed Preventive
Medicine specialty set.
B.38. Preventive Medicine
§
0059
!
NIA
I
001
(Outcome)
!
(Care
Coordination)
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I
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!
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Claims Measure
Specifications,
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Specifications
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Claims Measure
Specifications,
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Specifications
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Diabetes: Hemoglobin Ale
(HbAlc) Poor Control(> 9%):
Percentage of patients 18-75
years of age with diabetes who
had hemoglobin Ale> 9.0%
during the measurement period.
Communication with the
Physician or Other Clinician
Managing On-Going Care PostFracture for Men and Women
Aged 50 Years and Older:
Percentage of patients aged 50
years and o Ider treated for a
fracture with documentation of
communication, between the
physician treating the fracture
and the physician or other
clinician managing the patient's
on-going care, that a fracture
occurred and that the patient was
or should be considered for
osteoporosis treatment or testing.
This measure is submitted by the
physician who treats the fracture
and who therefore is held
accountable for the
communication.
Screening for Osteoporosis for
Women Aged 65-85 Years of
Age:
Percentage of women aged 65-85
years of age who ever had a
central dual-energy X-ray
absorptiometry (DXA) to check
for osteo orosis.
Advance Care Plan:
Percentage of patients aged 65
years and older who have an
advance care plan or surrogate
decision maker documented in
the medical record or
documentation in the medical
record that an advance care plan
was discussed but the patient did
not wish or was not able to name
a surrogate decision maker or
rovide an advance care Ian.
E:\FR\FM\31JYP2.SGM
31JYP2
National
Committee for
Quality
Assurance
National
Committee for
Quality
Assurance
National
Committee for
Quality
Assurance
National
Committee for
Quality
Assurance
EP31JY24.426
*
Medicare Part B
Claims Measure
Specifications,
eCQM
Specifications,
MIPS CQM
S ecifications
62469
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
B.38. Preventive Medicine
•·
Tndfoa_tor •
.
',
PREVIOUSiY FTNALIZEJJ MEJ\SURESJN THE PREVENTJVE MtDI.CiNE SPECIALTY-Sift
..
..
.
'.
.CBE#
.
CMS
f
·
Measure··,.
.Measure Ti(le
~uality
eCQM (:ollection 'fype •
••••
Type
#
an_d Description
C:CQM
.
CBE#
NIAi
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§
!
(Appropriate
Use)
*
§
!
(Patient
Safety)
§
0058 I
NIA
...
048
116
TU
MIPS CQM
Specifications
N/A
MIPS CQM
Specifications
Process
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68v14
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Specifications,
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CMS
2vl4
Medicare Part B
Claims Measure
Specifications,
eCQM
Specifications,
MIPS CQM
Specifications
Process
155
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Ste:war
.
62470
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
B.38. Preventive Medicine
Indicator
*
§
!
(Care
Coordination)
!
(Care
Coordination)
*
!
(Care
Coordination)
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VerDate Sep<11>2014
PREVIOUSLY FINALIZED MEASURES IN THE PREVENTIVE MEDICINE SPECIALTY SET
CBE#
CMS
..
I
Quality
Measure
Measure Title
eCQM Collection Type
#
eCQM
Type
and Description
ID
CBE#
Functional Outcome
Assessment:
Percentage of visits for patients
aged 18 years and older with
documentation of a current
functional outcome assessment
MIPS CQM
using a standardized functional
NIAi
Process
182
NIA
NIA
Specifications
outcome assessment tool on the
date of the encounter AND
documentation of a care plan
based on identified functional
outcome deficiencies within two
days of the date of the identified
deficiencies.
Cardiac Rehabilitation Patient
Referral from an Outpatient
Setting:
Percentage of patients evaluated
in an outpatient setting who
within the previous 12 months
have experienced an acute
myocardial infarction (Ml),
coronary artery bypass graft
MIPS CQM
(CABG) surgery, a percutaneous
0643 I
243
N/A
Process
coronary intervention (PCI),
N/A
Specifications
cardiac valve surgery, or cardiac
transplantation, or who have
chronic stable angina (CSA) and
have not already participated in
an early outpatient cardiac
rehabilitation/secondary
prevention (CR) program for the
qualifying event/diagnosis who
were referred to a CR program.
Closing the Referral Loop:
Receipt of Specialist Report:
eCQM
Percentage of patients with
NIAi
CMS
Specifications,
referrals, regardless of age, for
374
Process
MIPS CQM
N/A
50v13
which the referring clinician
Specifications
receives a report from the
clinician to whom the patient was
referred.
Preventive Care and Screening:
Unhealthy Alcohol Use:
Screening & Brief Counseling:
Percentage of patients aged 18
years and older who were
MIPS CQM
screened for unhealthy alcohol
2152 I
431
N/A
Process
NIA
Specifications
use using a systematic screening
method at least once within the
last 12 months AND who
received brief counseling if
identified as an unhealthy alcohol
user.
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Measure
Ste"'.ard
Centers for
Medicare &
Medicaid
Services
American Heart
Association
Centers for
Medicare &
Medicaid
Services
National
Committee for
Quality
Assurance
EP31JY24.428
'
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62471
B.38. Preventive Medicine
eCQM
Specifications,
MIPS CQM
Specifications
Process
NIAi
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475
CMS
349v7
eCQM
Specifications
Process
!
(Equity)
NIAi
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487
NIA
MIPS CQM
Specifications
Process
*
NIAi
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488
CMS
951v3
eCQM
Specifications,
MIPS CQM
Specifications
Process
NIA
493
NIA
MIPS CQM
Specifications
Process
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VerDate Sep<11>2014
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Centers for
Medicare &
Medicaid
Services
Centers for
Disease Control
and Prevention
Centers for
Medicare &
Medicaid
Services
National Kidney
Foundation
National
Committee for
Quality
Assurance
EP31JY24.429
438
CMS
347v8
§
Statin Therapy for the
Prevention and Treatment of
Cardiovascular
Disease:
Percentage of the following
patients - all considered at high
risk of cardiovascular events who were prescribed or were on
statin therapy during the
performance period:
•All patients who were previously
diagnosed with or currently have
a diagnosis of clinical
atherosclerotic cardiovascular
disease (ASCVD), including an
ASCVD procedure; OR
•Patients aged 20 to 75 years who
have ever had a low-density
lipoprotein cholesterol (LDL-C)
level 2: 190 mgldL or were
previously diagnosed with or
currently have an active diagnosis
of familial hypercholesterolemia;
OR
•Patients aged 40 to 75 years with
a diagnosis of diabetes; OR
•Patients aged 40 to 75 with a 10year ASCVD risk score of 2: 20
ercent.
HIV Screening:
Percentage of patients aged 15-65
at the start of the measurement
period who were between 15-65
years old when tested for Human
Immunodeficienc Virus HIV.
Screening for Social Drivers of
Health:
Percent of patients 18 years and
older screened for food
insecurity, housing instability,
transportation needs, utility
difficulties, and interpersonal
safet .
Kidney Health Evaluation:
Percentage of patients aged 18-75
years with a diagnosis of diabetes
who received a kidney health
evaluation defined by an
Estimated Glomerular Filtration
Rate (eGFR) AND Urine
Albumin-Creatinine Ratio
(uACR) within the measurement
eriod.
Adult Immunization Status:
Percentage of patients 19 years of
age and older who are up-to-date
on recommended routine
vaccines for influenza; tetanus
and diphtheria (Td) or tetanus,
diphtheria and acellular pertussis
(Tdap); zoster; and
neumococcal.
62472
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
B.38. Preventive Medicine
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*
!
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PatientReported
OutcomeBased
Performanc
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Sfmt 4725
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Centers for
Medicare and
Medicaid
Services
OCHIN
Insignia Health,
LLC, a wholly
owned
subsidiary of
Phreesia
EP31JY24.430
*
Preventive Care and Wellness
(composite):
Percentage of patients who
received age- and sex-appropriate
preventive screenings and
wellness services. This measure
is a composite of seven
component measures that are
based on recommendations for
preventive care by the U.S.
Preventive Services Task Force
(USPSTF), ACIP, American
Association of Clinical
Endocrinology (AACE), and
American College of
ACE).
Endocrinolo
Connection to Community
Service Provider:
Percent of patients 18 years or
older who screen positive for one
or more of the following health
related social needs (HRSNs):
food insecurity, housing
instability, transportation needs,
utility help needs, or
interpersonal safety; and had
contact with a Community
Service Provider ( CSP) for at
least 1 of their HRSNs within 60
da s after screenin .
Gains in Patient Activation
Measure (PAM®) Scores at 12
Months:
The Patient Activation Measure®
(PAM®) is a 10- or 13 - item
questionnaire that assesses an
individual's knowledge, skills
and confidence for managing
their health and health care. The
measure assesses individuals on a
0-100 scale that converts to one
of four levels of activation, from
low (1) to high (4). The PAM®
performance measure (PAM®PM) is the change in score on the
PAM® from baseline to followu measurement.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62473
B.38. Preventive Medicine
119
120
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for
Medicare
&
Medicaid
Services
See footnote lkeokwu et al., 2023 in Table B.l of this Appendix.
See footnotes Fitzpatrick et al., 2022; Polack et al., 2020; and Grana et al., 2022 in Table A.5 of this Appendix.
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CQM
Specificati
ons
Adult COVID19 Vaccination
Status:
Percentage of
patients aged 18
years and older
seen for a visit
during the
performance
period that are up
to date on their
COVID-19
vaccinations as
defined by CDC
recommendation
son current
vaccination.
We are proposing to include this
measure in the Preventive
Medicine specialty set as it would
be clinically relevant to this
clinician type. Widespread
vaccination against SARS-CoV-2,
the virus that causes CO VID-19,
is critically important to stemming
the morbidity and mortality
caused by this disease. 119
Clinicians are uniquely positioned
to encourage uptake ofCOVID19 vaccination, and clinicians are
still a major driving force in
promoting patient vaccination.
The addition of this quality
measure in this specialty set
would help strengthen compliance
with recommended COVID-19
vaccination, leading to
improvement in the quality of
patient care and prevention of
disease for the general population.
This quality measure aligns with
clinical guidelines and the
evidence-based recommendations
of the ACIP, where there is
general agreement about the
safety and efficacy of the
COVID-19 vaccine, preventing
costly and potentially harmful
hospitalizations. 120 Broadening
vaccination status awareness to
this clinician type is valuable as it
can help drive an increase in the
adult vaccination rates. The
COVID-19 vaccination included
within this measure would reduce
the prevalence of severe diseases
that may be associated with
hospitalization and decrease
overall health care costs. The
measure being added to this
specialty set would be contingent
on the inclusion of applicable
coding by the time of the CY
2025 PFS final rule. In the event
appropriate coding is not included
in the final specification, this
measure would not be finalized
for inclusion within this specialty
measure set. See Table A.5 of this
Appendix for rationale, including
clinical evidence supporting the
inclusion of this measure in
MIPS.
62474
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
B.39. Pulmonology
In addition to the considerations discussed in the introductory language of Table Group B of this Appendix to this proposed rule,
the Pulmonology specialty set takes additional criteria into consideration, which includes, but is not limited to: whether a measure
reflects current clinical guidelines, and the coding of the measure includes relevant clinician types. We may reassess the
appropriateness of individual measures, on a case-by-case basis, to ensure appropriate inclusion in the specialty set. Measure
tables in this set include previously finalized measures we are maintaining within the set, measures proposed to be added, and
measures proposed for removal, as applicable. We request comment on the measures available in the proposed Pulmonology
specialty set.
B.39. Pulmonology
•·.·
·•
*
§
!
(Patient
Safety)
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VerDate Sep<11>2014
i
..
·
li1.die11tor
*
!
(Care
Coordination)
PREVIOUSLYFtNALIZ.EI>
MEAStJRES
IN. THE PULMONOLOGY SPECIAL TY.SET
..
..
.·.
.•
I<
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CBE#
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Measure
CoHeetion
l
Q1111lity
Meitsure
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.
.
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.. ·•·•·•
0326 I
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047
NIA
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Specifications,
MIPS CQM
Specifications
0102 I
NIA
052
NIA
MIPS CQM
Specifications
130
CMS68
vl4
eCQM
Specifications,
MIPS CQM
Specifications
Process
CMS13
8vl3
Medicare Part
B Claims
Measure
Specifications,
eCQM
Specifications,
MIPS CQM
Specifications
Process
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Process
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Advance Care Plan:
Percentage of patients aged 65
years and older who have an
advance care plan or surrogate
decision maker documented in the
medical record or documentation
in the medical record that an
advance care plan was discussed
but the patient did not wish or was
not able to name a surrogate
decision maker or provide an
advance care plan.
Chronic Obstructive Pulmonary
Disease (COPD): Spirometry
Evaluation and Long-Acting
Inhaled Bronchodilator
Therapy:
Percentage of patients aged 18
years and older with a diagnosis of
COPD with a documented
FEVl/FVC < 70% measured by
spirometry, who are symptomatic
and were prescribed a long-acting
inhaled bronchodilator.
Documentation of Current
Medications in the Medical
Record:
Percentage of visits for patients
aged 18 years and older for which
the eligible clinician attests to
documenting a list of current
medications using all immediate
resources available on the date of
the encounter.
Preventive Care and Screening:
Tobacco l!se: Screening and
Cessation Intervention:
Percentage of patients aged 12
years and older who were screened
for tobacco use one or more times
during the measurement period
AND who received tobacco
cessation intervention during the
measurement period or in the six
months prior to the measurement
period if identified as a tobacco
user.
E:\FR\FM\31JYP2.SGM
31JYP2
I·
..
·.
.·
. Measure
Stewa.rd
•
..··
I•
National
Committee for
Quality
Assurance
American
Thoracic
Society
Centers for
Medicare &
Medicaid
Services
National
Committee for
Quality
Assurance
EP31JY24.432
..
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62475
B.39. Pulmonology
§
!
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0022 I
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Specifications,
MIPS CQM
Specifications
Process
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Specifications
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(Outcome)
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Outcome
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Specifications
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CMS50
vl3
eCQM
Specifications,
MIPS CQM
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Specifications
Outcome
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National
Committee for
Quality
Assurance
National
Committee for
Quality
Assurance
American
Academy of
Sleep
Medicine
American
Academy of
Sleep
Medicine
Centers for
Medicare &
Medicaid
Services
Minnesota
Community
Measurement
EP31JY24.433
*
Medicare Part
B Claims
Measure
Specifications,
eCQM
Specifications,
MIPS CQM
Specifications
Controlling High Blood
Pressure:
Percentage of patients 18-85 years
of age who had a diagnosis of
essential hypertension starting
before and continuing into, or
starting during the first six months
of the measurement period, and
whose most recent blood pressure
was adequately controlled
(<140190mmHg) during the
measurement eriod.
Use of High-Risk Medications in
Older Adults:
Percentage of patients 65 years of
age and older who were ordered at
least two high-risk medications
from the same dru class.
Sleep Apnea: Severity
Assessment at Initial Diagnosis:
Percentage of patients aged 18
years and older with a diagnosis of
obstructive sleep apnea who had
an apnea hypopnea index (AHI), a
respiratory disturbance index
(RD!), or a respiratory event index
(REI) documented or measured
within 2 months of initial
evaluation for suspected
obstructive slee a nea.
Sleep Apnea: Assessment of
Adherence to Obstructive Sleep
Apnea (OSA) Therapy:
Percentage of patients aged 18
years and older with a diagnosis of
obstructive sleep apnea (OSA) that
were prescribed an evidence-based
therapy that had documentation
that adherence to therapy was
assessed at least annually through
an objective informatics system or
through selt:reporting (ifobjective
re ortin is not available .
Closing the Referral Loop:
Receipt of Specialist Report:
Percentage of patients with
referrals, regardless of age, for
which the referring clinician
receives a report from the clinician
to whom the atient was referred.
Optimal Asthma Control:
Composite measure of the
percentage of pediatric and adult
patients whose asthma is wellcontrolled as demonstrated by one
of three age appropriate patient
reported outcome tools and not at
risk for exacerbation.
62476
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
B.39. Pulmonology
2152
I
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!
(Equity)
*
*
!
(Equity)
*
!
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(Outcome)
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431
NIA
MIPS CQM
Specifications
Process
487
NIA
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Specifications
Process
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NIA
MIPS CQM
Specifications
Process
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Specifications
Process
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Specifications
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PatientReported
OutcomeBased
Performance
Measure
Sfmt 4725
E:\FR\FM\31JYP2.SGM
31JYP2
National
Committee for
Quality
Assurance
Centers for
Medicare &
Medicaid
Services
National
Committee for
Quality
Assurance
OCHIN
Insignia
Health, LLC, a
wholly owned
subsidiary of
Phreesia
EP31JY24.434
§
Preventive Care and Screening:
Unhealthy Alcohol Use:
Screening & Brief Counseling:
Percentage of patients aged 18
years and older who were screened
for unhealthy alcohol use using a
systematic screening method at
least once within the last 12
months AND who received brief
counseling if identified as an
unhealth alcohol user.
Screening for Social Drivers of
Health:
Percent of patients 18 years and
older screened for food insecurity,
housing instability, transportation
needs, utility difficulties, and
inter ersonal safe! .
Adult Immunization Status:
Percentage of patients 19 years of
age and older who are up-to-date
on recommended routine vaccines
for influenza; tetanus and
diphtheria (Td) or tetanus,
diphtheria and acellular pertussis
Tda ; zoster; and neumococcal.
Connection to Community
Service Provider:
Percent of patients 18 years or
older who screen positive for one
or more of the following health
related social needs (HRSNs):
food insecurity, housing
instability, transportation needs,
utility help needs, or interpersonal
safety; and had contact with a
Community Service Provider
(CSP) for at least 1 of their HRSNs
within 60 da s after screenin .
Gains in Patient Activation
Measure (PAM®) Scores at 12
Months:
The Patient Activation Measure®
(PAM®) is a 10- or 13 - item
questionnaire that assesses an
individual's knowledge, skills and
confidence for managing their
health and health care. The
measure assesses individuals on a
0-100 scale that converts to one of
four levels of activation, from low
(1) to high (4). The PAM®
performance measure (PAM®PM) is the change in score on the
PAM® from baseline to follow-up
measurement.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62477
B.39. Pulmonology
NIAi
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TBD
NIA
MIPS
CQM
Specificati
ons
Process
Adult COVID19 Vaccination
Status:
Percentage of
patients aged 18
years and older
seen for a visit
during the
performance
period that are up
to date on their
COVID-19
vaccinations as
defined by CDC
recommendation
son current
vaccination.
Centers
for
Medicare
&
Medicaid
Services
We are proposing to include this
measure in the Pulmonology
Medicine specialty set as it would
be clinically relevant to this
clinician type. Widespread
vaccination against SARS-CoV-2,
the virus that causes CO VID-19,
is critically important to stemming
the morbidity and mortality
caused by this disease. 121
Clinicians are uniquely positioned
to encourage uptake ofCOVID19 vaccination, and clinicians are
still a major driving force in
promoting patient vaccination.
The addition of this quality
measure in this specialty set
would help strengthen compliance
with recommended COVID-19
vaccination, leading to
improvement in the quality of
patient care and prevention of
disease for the general population.
This quality measure aligns with
clinical guidelines and the
evidence-based recommendations
of the ACIP, where there is
general agreement about the
safety and efficacy of the
COVID-19 vaccine, preventing
costly and potentially harmful
hospitalizations. 122 Broadening
vaccination status awareness to
this clinician type is valuable as it
can help drive an increase in the
adult vaccination rates. The
COVID-19 vaccination included
within this measure would reduce
the prevalence of severe diseases
that may be associated with
hospitalization and decrease
overall health care costs. The
measure being added to this
specialty set would be contingent
on the inclusion of applicable
coding by the time of the CY
2025 PFS fmal rule. In the event
appropriate coding is not included
in the final specification, this
measure would not be fmalized
for inclusion within this specialty
measure set. See Table A.5 of this
Appendix for rationale, including
clinical evidence supporting the
inclusion of this measure in
MIPS.
121
122
VerDate Sep<11>2014
See footnote lkeokwu et al., 2023 in Table B.l of this Appendix.
See footnotes Fitzpatrick et al., 2022; Polack et al., 2020; and Grana et al., 2022 in Table A.5 of this Appendix.
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B.40. Rheumatology
62478
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
In addition to the considerations discussed in the introductory language of Table Group B of this Appendix to this proposed rule,
the Rheumatology specialty set takes additional criteria into consideration, which includes, but is not limited to: whether a
measure reflects current clinical guidelines, and the coding of the measure includes relevant clinician types. We may reassess the
appropriateness of individual measures, on a case-by-case basis, to ensure appropriate inclusion in the specialty set. Measure
tables in this set include previously finalized measures we are maintaining within the set, measures proposed to be added, and
measures proposed for removal, as applicable. We request comment on the measures available in the proposed Rheumatology
specialty set.
B.40. Rheumatology
NIAi
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I
NIA
*
!
(Care
Coordination)
0326
I
NIA
NIA
Process
NIA
Medicare Part
B Claims
Measure
Specifications,
MIPS CQM
Specifications
Process
047
NIA
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B Claims
Measure
Specifications,
MIPS CQM
Specifications
Process
130
CMS68
vl4
eCQM
Specifications,
MIPS CQM
Specifications
Process
024
039
*
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Safety)
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National Committee
for Quality Assurance
National Committee
for Quality Assurance
National Committee
for Quality Assurance
Centers for Medicare
& Medicaid Services
EP31JY24.436
!
(Care
Coordination)
Medicare Part
B Claims
Measure
Specifications,
MIPS CQM
Specifications
Communication with the
Physician or Other Clinician
Managing On-Going Care
Post-Fracture for Men and
Women Aged 50 Years and
Older:
Percentage of patients aged 50
years and older treated for a
fracture with documentation
of communication, between
the physician treating the
fracture and the physician or
other clinician managing the
patient's on-going care, that a
fracture occurred and that the
patient was or should be
considered for osteoporosis
treatment or testing. This
measure is submitted by the
physician who treats the
fracture and who therefore is
held accountable for the
conununication.
Screening for Osteoporosis
for Women Aged 65-85
Years of Age:
Percentage of women aged
65-85 years of age who ever
had a central dual-energy Xray absorptiometry (DXA) to
check for osteo orosis.
Advance Care Plan:
Percentage of patients aged 65
years and older who have an
advance care plan or surrogate
decision maker documented in
the medical record or
documentation in the medical
record that an advance care
plan was discussed but the
patient did not wish or was
not able to name a surrogate
decision maker or provide an
advance care Ian.
Documentation of Current
Medications in the Medical
Record:
Percentage of visits for
patients aged 18 years and
older for which the eligible
clinician attests to
documenting a list of current
medications using all
immediate resources available
on the date of the encounter.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62479
B.40. Rheumatology
.
,•
*
*
*
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Indicator
PREVIOUSLY FINALIZED MEASURES IN THE RHEUMATOLOGY SPECIALTY SET
CBE#
CMS
Quality
Collection
Measµre Title. and
I
Measure
eCQM
Measure Steward
Type
#
Type
Description
eCQM
TD
CBE#
Tuberculosis Screeuiug
Prior to First Course of
Biologic and/or Immune
Response Modifier Therapy:
If a patient has been newly
prescribed a biologic and/or
NIAi
MIPS CQM
Process
American College of
176
N/A
immune response modifier
Specifications
Rheumatology
NIA
that includes a warning for
potential reactivation of a
latent infection, then the
medical record should indicate
TB testing in the preceding
12-month period.
Rheumatoid Arthritis (RA):
Periodic Assessment of
Disease Activity:
Percentage of patients aged 18
years and older with a
diagnosis of rheumatoid
MIPS CQM
Process
2523 I
American College of
177
NIA
arthritis (RA) who have an
NIA
Specifications
Rheumatology
assessment of disease activity
using an ACR-preferred RA
disease activity assessment
tool at ::>50% of encounters for
RA for each patient during the
performance period.
Rheumatoid Arthritis (RA):
Functional Status
Assessment:
Percentage of patients aged 18
years and older with a
American College of
NIAi
MIPS CQM
178
NIA
Process
diagnosis ofrheumatoid
Rheumatology
NIA
Specifications
arthritis (RA) for whom a
functional status assessment
was performed at least once
during the performance
period.
Rheumatoid Arthritis (RA):
Glucocorticoid
Management:
Percentage of patients aged 18
years and older with a
diagnosis ofrheumatoid
arthritis (RA) who have been
assessed for glucocorticoid
NIAi
MIPS CQM
American College of
Process
use and, for those on
180
NIA
NIA
Specifications
Rheumatology
prolonged doses ofprednisone
> 5 mg daily (or equivalent)
with improvement or no
change in disease activity,
documentation of
glucocorticoid management
plan during the performance
period.
62480
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
B.40. Rheumatology
•
§
!
(Outcome)
*
!
(Patient
Safety)
*
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*
!
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NIAi
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CMSl3
8vl3
Process
236
CMS16
5v13
Medicare Part
B Claims
Measure
Specifications,
eCQM
Specifications,
MIPSCQM
Specifications
lntermedi
ate
Outcome
238
CMS15
6v13
eCQM
Specifications,
MIPSCQM
Specifications
Process
317
CMS22
v13
Medicare Part
B Claims
Measure
Specifications,
eCQM
Specifications,
MIPSCQM
Specifications
Process
374
CMS50
v13
eCQM
Specifications,
MIPSCQM
Specifications
Process
487
NIA
MIPSCQM
Specifications
Process
226
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National Committee
for Quality Assurance
National Committee
for Quality Assurance
National Committee
for Quality Assurance
Centers for Medicare
& Medicaid Services
Centers for Medicare
& Medicaid Services
Centers for Medicare
& Medicaid Services
EP31JY24.438
§
Medicare Part
B Claims
Measure
Specifications,
eCQM
Specifications,
MIPSCQM
Specifications
Preventive Care and
Screening: Tobacco Use:
Screening and Cessation
Intervention:
Percentage of patients aged 12
years and older who were
screened for tobacco use one
or more times during the
measurement period AND
who received tobacco
cessation intervention during
the measurement period or in
the six months prior to the
measurement period if
identified as a tobacco user.
Controlling High Blood
Pressure:
Percentage of patients 18-85
years of age who had a
diagnosis of essential
hypertension starting before
and continuing into or starting
during the first six months of
the measurement period, and
whose most recent blood
pressure was adequately
controlled (<140190mmHg)
during the measurement
eriod.
Use of High-Risk
Medications in Older
Adults:
Percentage of patients 65
years of age and older who
were ordered at least two
high-risk medications from
the same dru class.
Preventive Care and
Screening: Screening for
High Blood Pressure and
Follow-Up Documented:
Percentage of patient visits for
patients aged 18 years and
older seen during the
measurement period who were
screened for high blood
pressure AND a
recommended follow-up plan
is documented, as indicated, if
blood pressure is elevated or
h ertensive.
Closing the Referral Loop:
Receipt of Specialist Report:
Percentage of patients with
referrals, regardless ofage, for
which the referring clinician
receives a report from the
clinician to whom the patient
was referred.
Screening for Social Drivers
of Health:
Percent of patients I 8 years
and older screened for food
insecurity, housing instability,
transportation needs, utility
difficulties, and interpersonal
safe
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62481
8.40. Rheumatology
*
!
(Equity)
*
!
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(Outcome)
VerDate Sep<11>2014
3620 I
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493
NIA
MIPS CQM
Specifications
Process
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498
NIA
MIPS CQM
Specifications
Process
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Specifications
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PatientReported
OutcomeBased
Performan
ce
Measure
Sfmt 4725
E:\FR\FM\31JYP2.SGM
31JYP2
National Committee
Quality Assurance
OCHTN
Insignia Health, LLC,
a wholly owned
subsidiary of Phreesia
EP31JY24.439
*
Adult Immunization Status:
Percentage of patients 19
years of age and older who are
up-to-date on recommended
routine vaccines for influenza;
tetanus and diphtheria (Td) or
tetanus, diphtheria and
acellular pertussis (Tdap);
zoster; and neumococcal.
Connection to Community
Service Provider:
Percent of patients 18 years or
older who screen positive for
one or more of the following
health related social needs
(HRSNs): food insecurity,
housing instability,
transportation needs, utility
help needs, or interpersonal
safety; and had contact with a
Community Service Provider
(CSP) for at least I of their
HRSNs within 60 days after
screenin .
Gains in Patient Activation
Measure (PAM®) Scores at
12 Months:
The Patient Activation
Measure® (PAM®) is a 10or 13 - item questionnaire that
assesses an individual's
knowledge, skills and
confidence for managing their
health and health care. The
measure assesses individuals
on a 0-100 scale that converts
to one of four levels of
activation, from low (I) to
high (4). The PAM®
performance measure
(PAM®-PM) is the change in
score on the PAM® from
baseline to follow-up
measurement.
62482
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
B.40. Rheumatology
Adult COVID-
123
124
VerDate Sep<11>2014
TBD
NIA
Process
Centers
for
Medicare
&
Medicaid
Services
See footnote lkeokwu et al., 2023 in Table B.l of this Appendix.
See footnotes Fitzpatrick et al., 2022; Polack et al., 2020; and Grana et al., 2022 in Table A.5 of this Appendix.
20:32 Jul 30, 2024
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NIAi
NIA
MIPS
CQM
Specificati
ons
19 Vaccination
Status:
Percentage of
patients aged 18
years and older
seen for a visit
during the
performance
period that are up
to date on their
COVID-19
vaccinations as
defined by CDC
recommendation
son current
vaccination.
We are proposing to include this
measure in the Rheumatology
Medicine specialty set as it would
be clinically relevant to this
clinician type. Widespread
vaccination against SARS-CoV-2,
the virus that causes CO VID-19,
is critically important to stemming
the morbidity and mortality
caused by this disease. 123
Clinicians are uniquely positioned
to encourage uptake ofCOVID19 vaccination, and clinicians are
still a major driving force in
promoting patient vaccination.
The addition of this quality
measure in this specialty set
would help strengthen compliance
with recommended COVID-19
vaccination, leading to
improvement in the quality of
patient care and prevention of
disease for the general population.
This quality measure aligns with
clinical guidelines and the
evidence-based recommendations
of the ACIP, where there is
general agreement about the
safety and efficacy of the
COVID-19 vaccine, preventing
costly and potentially harmful
hospitalizations. 124 Broadening
vaccination status awareness to
this clinician type is valuable as it
can help drive an increase in the
adult vaccination rates. The
COVID-19 vaccination included
within this measure would reduce
the prevalence of severe diseases
that may be associated with
hospitalization and decrease
overall health care costs. The
measure being added to this
specialty set would be contingent
on the inclusion of applicable
coding by the time of the CY
2025 PFS final rule. In the event
appropriate coding is not included
in the final specification, this
measure would not be fmalized
for inclusion within this specialty
measure set. See Table A.5 of this
Appendix for rationale, including
clinical evidence supporting the
inclusion of this measure in
MIPS.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62483
8.41. Skilled Nursing Facility
In addition to the considerations discussed in the introductory language of Table Group B of this Appendix to this proposed rule,
the Skilled Nursing Facility specialty set takes additional criteria into consideration, which includes, but is not limited to: whether
a measure reflects current clinical guidelines, and the coding of the measure includes relevant clinician types. We may reassess
the appropriateness of individual measures, on a case-by-case basis, to ensure appropriate inclusion in the specialty set. Measure
tables in this set include previously finalized measures we are maintaining within the set, measures proposed to be added, and
measures proposed for removal, as applicable. We request comment on the measures available in the proposed Skilled Nursing
Facility specialty set.
8.41. Skilled Nursing Facility
§
§
*
!
(Care
Coordinat
ion)
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§
VerDate Sep<11>2014
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00701
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00831
0083e
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NIA
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006
NIA
MIPSCQM
Specifications
Process
007
CMSl
45vl3
eCQM
Specifications,
MIPSCQM
Specifications
Process
008
CMSl
44vl3
eCQM
Specifications,
MIPSCQM
Specifications
Process
047
NIA
Medicare Part
BC!aims
Measure
Specifications,
MIPS CQM
Specifications
Process
118
NIA
MIPSCQM
Specifications
Process
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American Heart
Association
American Heart
Association
American Heart
Association
National Committee
for Quality Assurance
American Heart
Association
EP31JY24.441
§
Coronary Artery Disease (CAD):
Antiplatelet Therapy:
Percentage of patients aged 18 years
and older with a diagnosis of
coronary artery disease (CAD) seen
within a 12-month period who were
rescribed as irin or clo ido rel.
Coronary Artery Disease (CAD):
Beta-Blocker Therapy- Prior
Myocardial Infarction (Ml) or
Left Ventricular Systolic
Dysfunction (LVEF :5 40%):
Percentage of patients aged 18 years
and older with a diagnosis of
coronary artery disease seen within
a 12-month period who also have a
prior Ml or a current or prior LVEF
:5 40% who were prescribed betablocker thera
Heart Failure (HF): Beta-Blocker
Therapy for Left Ventricular
Systolic Dysfunction (LVSD):
Percentage of patients aged 18 years
and older with a diagnosis of heart
failure (HF) with a current or prior
left ventricular ejection fraction
(LVEF) :5 40% who were prescribed
beta-blocker therapy either within a
12-month period when seen in the
outpatient setting OR at each
hos ital dischar e.
Advance Care Plan:
Percentage of patients aged 65 years
and older who have an advance care
plan or surrogate decision maker
documented in the medical record
or documentation in the medical
record that an advance care plan
was discussed but the patient did not
wish or was not able to name a
surrogate decision maker or provide
an advance care Ian.
Coronary Artery Disease (CAD):
Angiotensin-Converting Enzyme
(ACE) Inhibitor or Angiotensin
Receptor Blocker (ARB) Therapy
- Diabetes or Left Ventricular
Systolic Dysfunction (LVEJ<" :5
40%):
Percentage of patients aged 18 years
and older with a diagnosis of
coronary artery disease seen within
a 12-month period who also have
diabetes OR a current or prior Left
Ventricular Ejection Fraction
(L VEF) :5 40% who were prescribed
ACE inhibitor or ARB thera
62484
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
8.41. Skilled Nursing Facility
!
(Care
Coordinat
ion)
0101 I
NIA
155
NIA
NIAi
NIA
181
NIA
Medicare Part
B Claims
Measure
Specifications,
MIPS CQM
Specifications
0022 I
NIA
238
CMSl
56v13
eCQM
Specifications,
MIPS CQM
Specifications
*
!
(Patient
Safety)
*
!
(Patient
Safety)
*
NIAi
NIA
NIAi
NIA
§
!
(Equity)
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*
VerDate Sep<11>2014
Medicare Part
B Claims
Measure
Specifications,
MIPS CQM
S ecifications
317
326
CMS2
2vl3
Medicare Part
B Claims
Measure
Specifications,
eCQM
Specifications,
MIPS CQM
Specifications
Process
Process
Process
Process
NIA
MIPS CQM
Specifications
Process
NIAi
NIA
487
NIA
MIPS CQM
Specifications
Process
3620 I
NIA
493
NIA
MIPS CQM
Specifications
Process
20:32 Jul 30, 2024
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Falls: Plan of Care:
Percentage of patients aged 65 years
and older with a history of falls who
had a plan of care for falls
documented within 12 months.
Fmt 4701
Elder Maltreatment Screen and
Follow-Up Plan:
Percentage of patients aged 60 years
and older with a documented elder
maltreatment screen using an Elder
Maltreatment Screening tool on the
date of encounter AND a
documented follow-up plan on the
date of the ositive screen.
Use of High-Risk Medications in
Older Adults:
Percentage of patients 65 years of
age and older who were ordered at
least two high-risk medications
from the same dru class.
Preventive Care and Screening:
Screening for High Blood
Pressure and Follow-lip
Documented:
Percentage of patient visits for
patients aged 18 years and older
seen during the measurement period
who were screened for high blood
pressure AND a recommended
follow-up plan is documented, as
indicated, if blood pressure is
elevated or h ertensive.
Atrial Fibrillation and Atrial
Flutter: Chronic Anticoagulation
Therapy:
Percentage of patients aged 18 years
and older with atrial fibrillation
(AF) or atrial flutter who were
prescribed an FDA-approved oral
anticoagulant drug for the
prevention ofthromboembolism
durin the measurement eriod.
Screening for Social Drivers of
Health:
Percent of patients 18 years and
older screened for food insecurity,
housing instability, transportation
needs, utility difliculties, and
inte ersonal safe
Adult Immunization Status:
Percentage of patients 19 years of
age and older who are up-to-date on
recommended routine vaccines for
influenza; tetanus and diphtheria
(Td) or tetanus, diphtheria and
acellular pertussis (Tdap); zoster;
and neumococcal.
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National Committee
for Quality Assurance
Centers for Medicare
& Medicaid Services
National Committee
for Quality
Assurance
Centers for
Medicare &
Medicaid Services
American Heart
Association
Centers for
Medicare &
Medicaid Services
National Committee
for Quality
Assurance
EP31JY24.442
*
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62485
8.41. Skilled Nursing Facility
E
1
t'CQ
('.BF;#
*
!
(Equity)
NIAi
NIA
NIA
498
MIPS CQM
Specifications
Process
Connection to Community
Service Provider:
Percent of patients 18 years or older
who screen positive for one or more
of the following health related
social needs (HRSNs): food
insecurity, housing instability,
transportation needs, utility help
needs, or interpersonal safety; and
had contact with a Community
Service Provider (CSP) for at least I
of their HRSNs within 60 days after
screenin .
OCHIN
8.41. Skilled Nursing Facility
We are proposing to include this
measure in the Skilled Nursing
Facility specialty set as it would
be clinically relevant to this
NIAi
NIA
TBD
NIA
MIPS
CQM
Speciticati
seen for a visit
during the
Process
perfonnance
period that are up
to date on their
COVID-19
ons
vaccinations as
defined by CDC
recommendation
lotter on DSK11XQN23PROD with PROPOSALS2
son current
vaccination.
VerDate Sep<11>2014
22:49 Jul 30, 2024
Centers
for
Medicare
&
Medicaid
Services
125
See footnote lkeokwu et al., 2023 in Table B.1 of this Appendix.
126
See footnotes Fitzpatrick et al., 2022; Polack et al., 2020; and Graiia et al., 2022 in Table A.5 of this Appendix.
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EP31JY24.444
Percentage of
patients aged 18
years and older
EP31JY24.443
AdoltCOVTD-
19 Vaccination
Status:
clinician type. Widespread
vaccination against SARS-Co V-2,
the virus that causes COVID-19,
is critically important to stemming
the morbidity and mortality
caused by this disease. 125
Clinicians are uniquely positioned
to encourage uptake ofCOVID19 vaccination, and clinicians are
still a major driving force in
promoting patient vaccination.
The addition of this quality
measure in this specialty set
would help strengthen compliance
with recommended COVJD-19
vaccination, leading to
improvement in the quality of
patient care and prevention of
disease for the general population.
This quality measure aligns with
clinical guidelines and the
evidence-based recommendations
of the ACIP, where there is
general agreement about the
safety and efficacy of the
COVID-19 vaccine, preventing
costly and potentially harmful
hospitalizations. 126 Broadening
vaccination status awareness to
this clinician type is valuable as it
can help drive an increase in the
adult vaccination rates. The
COVlD-19 vaccination included
within this measure would reduce
the prevalence of severe diseases
that may be associated with
hospitalization and decrease
overall health care costs. The
measure being added to this
specialty set would be contingent
on the inclusion of applicable
coding by the time of the CY
2025 PFS final rule. In the event
appropriate coding is not included
in the final specification, this
measure would not be fmalized
for inclusion within this specialty
measure set. See Table A.5 of this
Appendix for rationale, including
clinical evidence supporting the
inclusion of this measure in
MIPS.
62486
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
B.42. Speech Language Pathology
In addition to the considerations discussed in the introductory language of Table Group B of this Appendix to this proposed rule,
the Speech Language Pathology specialty set takes adclitional criteria into consideration, which includes, but is not limited to:
whether a measure reflects current clinical guidelines, and the coding of the measure includes relevant clinician types. We may
reassess the appropriateness of individual measures, on a case-by-case basis, to ensure appropriate inclusion in the specialty set.
Measure tables in this set include previously finalized measures we are maintaining within the set, measures proposed to be
added, and measures proposed for removal, as applicable. We request comment on the measures available in the proposed Speech
Language Pathology specialty set.
B.42. Speech Language Pathology
§
*
!
(Patient
Safety)
*
§
!
(Care
Coordinat
ion)
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§
VerDate Sep<11>2014
NIAi
NIA
NIAi
NIA
130
134
CMS68
v14
eCQM
Specifications,
MIPSCQM
Specifications
Process
CMS2v
14
Medicare Part
BClaims
Measure
Specifications,
eCQM
Specifications,
MlPSCQM
Specifications
Process
Process
NIAi
NIA
181
NIA
Medicare Part
BClaims
Measure
Specifications,
MIPSCQM
Specifications
NIAi
NIA
182
NIA
MIPSCQM
Specifications
Process
CMS13
8v13
Medicare Part
BClaims
Measure
Specifications,
eCQM
Specifications,
MIPSCQM
Specifications
Process
NIAi
NIA
20:32 Jul 30, 2024
226
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Centers for Medicare
& Medicaid Services
Centers for Medicare
& Medicaid Services
Centers for Medicare
& Medicaid Services
Centers for Medicare
& Medicaid Services
National Committee
for Quality Assurance
EP31JY24.445
*
§
!
(Patient
Safety)
Documentation of Current
Medications in the Medical
Record:
Percentage of visits for patients
aged 18 years and older for which
the eligible clinician attests to
documenting a list of current
medications using all immediate
resources available on the date of
the encounter.
Preventive Care and Screening:
Screening for Depression and
Follow-Up Plan:
Percentage of patients aged 12 years
and older screened for depression on
the date of the encounter or up to 14
days prior to the date of the
encounter using an age-appropriate
standardized depression screening
tool AND if positive, a follow-up
plan is documented on the date of or
up to two days after the date of the
uali in encounter.
Elder Maltreatment Screen and
Follow-Up Plan:
Percentage of patients aged 60 years
and older with a documented elder
maltreatment screen using an Elder
Maltreatment Screening tool on the
date of encounter AND a
documented follow-up plan on the
date of the ositive screen.
Functional Outcome Assessment:
Percentage of visits for patients
aged 18 years and older with
documentation of a current
functional outcome assessment
using a standardized functional
outcome assessmenttool on the date
of the encounter AND
documentation of a care plan based
on identified functional outcome
deficiencies within two days of the
date of the identified deficiencies.
Preventive Care and Screening:
Tobacco Use: Screening and
Cessation Intervention:
Percentage of patients aged 12 years
and older who were screened for
tobacco use one or more times
during the measurement period
AND who received tobacco
cessation intervention during the
measurement period or in the six
months prior to the measurement
period if identified as a tobacco
user.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62487
B.42. Speech Language Pathology
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PREVIOUSLY FINALIZED MEASURES IN THE SPEECH LANGUAGE PATHOLOGY SPECIALTY SET
CBE#
CMS
Measure
Measure Title
Quality
Collectiou
I
Type
eCQM
Measure Steward
Indicator
and Description
eC'QM
#
Type
ID
..
CBE#
Assessment of Cognitive
Impairment or Dysfunction for
Patients with Parkinson's Disease:
Percentage of all patients with a
American Academy
NIAi
MIPS CQM
diagnosis of Parkinson's Disease
291
NIA
Process
*
NIA
Specifications
of Neurology
(PD) who were assessed for
cognitive impairment or dysfunction
once during the measurement
period.
Screening for Social Drivers of
Health:
NIAi
MIPS CQM
Percent of patients 18 years and
Centers for Medicare
NIA
!
NIA
487
Specifications
Process
older screened for food insecurity,
(Equity)
& Medicaid Services
housing instability, transportation
needs, utility difficulties, and
interpersonal safety.
Connection to Community Service
Provider:
Percent of patients 18 years or older
who screen positive for one or more
of the following health related social
MIPS CQM
*
needs (HRSNs): food insecurity,
NIAi
498
NIA
Specifications
Process
OCHIN
!
NIA
housing instability, transportation
(Equity)
needs, utility help needs, or
interpersonal safety; and had contact
with a Community Service Provider
(CSP) for at least I of their HRSNs
within 60 days after screening.
62488
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
8.42. Speech Language Pathology
*
*
NIAi
2872e
NIAi
NIA
281
282
CM
Sl4
9v13
NIA
eCQM
Specificati
Process
Dementia:
Cognitive
Assessment:
Percentage of
patients,
regardless of age,
with a diagnosis
of dementia for
whom an
assessment of
cognition is
performed and the
results reviewed
at least once
within a 12-month
period.
American
Academy
of
Neurology
Process
Dementia:
Functional
Status
Assessment:
Percentage of
patients with
dementia for
whom an
assessment of
functional status
was performed at
least once in the
last 12 months.
American
Academy
of
Neurology/
American
Psychiatric
Association
ODS
MIPS
CQM
Specificati
ons
We are proposing to include
this measure in the Speech
Language Pathology specialty
set as it would be clinically
relevant to this clinician type.
Speech language pathologists
(SLPs) utilize standardized
instruments with demonstrated
reliability for dementia
screening. These instruments
typically assess orientation to
time, place, and person. 127
Other tests (for example, story
recall/story retelling) assess
episodic memory and can be
useful for screening early
dementia. 128 If screening
reveals cognitive impairment,
the individual is referred to an
SLP for a comprehensive
evaluation of communicative
function. The measure being
added to this specialty set
would be contingent on the
inclusion ofapplicable coding
by the time of the CY 2025
PFS final rule.
We are proposing to include
this measure in the Speech
Language Pathology specialty
set as it would be clinically
relevant to this clinician type.
SLPs play a critical role in
diagnosis and management of
dysphagia in patients with
dementia through
comprehensive assessment,
diet consistency modifications,
educating their caregiver on the
use of compensatory strategies,
prescribing exercise programs,
and referring them to other
professionals as needed. The
measure being added to this
specialty set would be
contingent on the inclusion of
applicable coding by the time
of the CY 2025 PFS fmal rule.
Rabin, L. A., Pare, N., Saykin, A. J., Brown, M. J., Wishart, H. A., Flashman, L.A., & Santulli, R. B. (2009).
Differential Memory Test Sensitivity for Diagnosing Amnestic Mild Cognitive Impairment and Predicting Conversion
to Alzheimer's Disease. Aging, Neuropsycho/ogy, and Cognition, 16(3), 357376. https://doi.org/10.1080/13825580902825220.
128 See footnote Rabin et al., 2009.
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Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62489
8.42. Speech Language Pathology
*
!
(Patient
Safety)
NIAi
NIA
286
NIA
*
!
(Care
Coordinat
ion)
NIAi
NIA
288
NIA
MIPS
CQM
Specificati
ons
MIPS
CQM
Specificati
ons
Process
Dementia: Safety
Concern
Screening and
Follow-Up for
Patients with
Dementia:
Percentage of
patients with
dementia or their
caregiver(s) for
whom there was a
documented
safety concerns
screening in two
domains of risk:
( I ) dangerousness
to self or others
and (2)
environmental
risks; and if safety
concerns
screening was
positive in the last
12 months, there
was
documentation of
mitigation
recommendations,
including but not
limited to referral
to other resources.
Process
Dementia:
Education and
Support of
Caregivers for
Patients with
Dementia:
Percentage of
patients with
dementia whose
caregiver(s) were
provided with
education on
dementia disease
management and
health behavior
changes AND
were referred to
additional
resources for
support in the last
12 months.
American
Psychiatric
Association
I American
Academy
of
Neurology
American
Academy
of
Neurology I
American
Psychiatric
Association
We are proposing to include
this measure in the Speech
Language Pathology specialty
set as it would be clinically
relevant to this clinician type.
Dementia patients are at high
risk for safety concerns due to
underlying cognitive
communication impairment
which may impactjudgment,
reasoning, and memory as well
as physical weakness resulting
from other medical
conditions. 129 SLPs work
directly with individuals with
dementia and their caregivers
to screen, assess, and establish
care plans to address these
issues through cognitivecommunication exercises, use
of compensatory strategies,
environmental modifications,
referrals to other professionals,
and providing caregiver
training. The measure being
added to this specialty set
would be contingent on the
inclusion ofapplicable coding
by the time of the CY 2025
PFS final rule.
We are proposing to include
this measure in the Speech
Language Pathology specialty
set as it would be clinically
relevant to this clinician type.
SLPs provide information
about the nature of dementia
and its course of progression.
SLPs make recommendations
for environmental
modifications, such as using
alarms and pill boxes for
medication reminders, visual
aids, and provide education on
common ication strategies and
modifications to caregiver
behaviors to ensure the safety
of the patient and compliance
with the plan of care. The
measure being added to this
specialty set would be
contingent on the inclusion of
applicable coding by the time
of the CY 2025 PFS final rule.
Thyrian, J. R., Hertel, J., Wucherer, D., Eichler, T., Michalowsky, B., Dreier-Wolfgramm, A., Zwingmann, I.,
Kilimann, I., Teipel, S., & Hoffmann, W. {2017). Effectiveness and Safety of Dementia Care Management in Primary
Care: A Randomized Clinical Trial. JAMA Psychiatry, 74(10), 996-1004.
https://doi.org/10.1001/jamapsychiatry.2017 .2124.
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62490
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
8.42. Speech Language Pathology
Amyotrophic
*
!
NIAi
NIA
386
NIA
MIPS
CQM
Specificati
ons
Process
American
Academy
of
Neurology
We are proposing to include
this measure in the Speech
Language Pathology specialty
set as it would be clinically
relevant to this clinician type.
Over the course of the disease,
individuals with ALS exhibit
difficulty producing intelligible
speech to communicate basic
needs and wants. 130 SLPs are
trained to address
communication deficits via
exercise programs, use of
communication strategies, and
introducing augmentative and
alternative communication
(AAC) methods. The measure
being added to this specialty
set would be contingent on the
inclusion of applicable coding
by the time of the CY 2025
PFS final rule.
National Institute of Neurological Disorders and Stroke. (2024). Amyotrophic Lateral Sclerosis.
https://www.ninds.ni h.gov/hea Ith-information/disorders/amyotrophic-lateral-sclerosis-a Is.
130
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(Patient
Experienc
e)
Lateral Sclerosis
(ALS) Patient
Care
Preferences:
Percentage of
patients diagnosed
with Amyotrophic
Lateral Sclerosis
(ALS) who were
offered assistance
in planning for
end oflife issues
(e.g., advance
directives,
invasive
ventilation, lawful
physicianhastened death, or
hospice) or whose
existing end oflife
plan was reviewed
or updated at least
once annually or
more frequency as
clinically
indicated (i.e.,
ra id ro ssion .
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62491
8.43. Thoracic Surgery
In addition to the considerations discussed in the introductory language of Table Group B of this Appendix to this proposed rule,
the Thoracic Surgery specialty set takes additional criteria into consideration, which includes, but is not limited to: whether a
measure reflects current clinical guidelines, and the coding of the measure includes relevant clinician types. We may reassess the
appropriateness of individual measures, on a case-by-case basis, to ensure appropriate inclusion in the specialty set. Measure
tables in this set include previously finalized measures we are maintaining within the set, measures proposed to be added, and
measures proposed for removal, as applicable. We request comment on the measures available in the proposed Thoracic Surgery
specialty set that have proposed substantive changes in Table Group D of this Appendix as indicated by an * in the Indicator
column.
B.43. Thoracic Surgery
047
NIA
*
§
!
(Patient
Safety)
NIA/NIA
130
CMS
68vl4
eCQM
Specifications,
MIPSCQM
Specifications
Process
!
(Outcome)
01291
NIA
164
NIA
MIPSCQM
Specifications
Outcome
!
(Outcome)
0114 I
NIA
167
NIA
MIPSCQM
Specifications
Outcome
*
0115 I
NIA
168
NIA
MIPSCQM
Specifications
Outcome
!
(Care
Coordination)
lotter on DSK11XQN23PROD with PROPOSALS2
!
(Outcome)
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National Committee
for Quality
Assurance
Centers for Medicare
& Medicaid Services
Society of Thoracic
Surgeons
Society of Thoracic
Surgeons
Society of Thoracic
Surgeons
EP31JY24.450
0326 I
NIA
Medicare Part
BClaims
Measure
Specifications,
MIPSCQM
Specifications
*
Advance Care Plan:
Percentage of patients aged 65
years and older who have an
advance care plan or surrogate
decision maker documented in
the medical record or
documentation in the medical
record that an advance care
plan was discussed but the
patient did not wish or was not
able to name a surrogate
decision maker or provide an
advance care Ian.
Documentation of Current
Medications in the Medical
Record:
Percentage of visits for patients
aged l 8 years and older for
which the eligible clinician
attests to documenting a list of
current medications using all
immediate resources available
on the date of the encounter.
Coronary Artery Bypass
Graft (CABG): Prolonged
Intubation:
Percentage of patients aged 18
years and older undergoing
isolated CABG surgery who
require postoperative
intubation > 24 hours.
Coronary Artery Bypass
Graft (CABG): Postoperative
Renal Failure:
Percentage of patients aged I 8
years and older undergoing
isolated CABG surgery
(without pre-existing renal
failure) who develop
postoperative renal failure or
re uire dial sis.
Coronary Artery Bypass
Graft (CABG): Surgical ReExploration:
Percentage of patients aged I 8
years and older undergoing
isolated CABG surgery who
require a return to the operating
room (OR) during the current
hospitalization for mediastinal
bleeding with or without
tamponade, graft occlusion,
valve dysfunction, or other
cardiac reason.
62492
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
B.43. Thoracic Surgery
!
(Outcome)
!
(Patient
Experience)
NIA/NIA
226
CMS
138vl
3
NIA/NIA
356
NIA
MIPSCQM
Specifications
Outcome
NIA/NIA
358
NIA
MIPSCQM
Specifications
Process
NIA/NIA
374
CMS
50v13
eCQM
Specifications,
MIPSCQM
Specifications
Process
0119 /
NIA
445
NIA
MIPSCQM
Specifications
Outcome
NIA/NIA
487
NIA
*
!
(Care
Coordination)
lotter on DSK11XQN23PROD with PROPOSALS2
§
!
(Outcome)
(Equity)
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31JYP2
National Committee
for Quality
Assurance
American College of
Surgeons
American College of
Surgeons
Centers for Medicare
& Medicaid Services
Society of Thoracic
Surgeons
Centers for Medicare
& Medicaid Services
EP31JY24.451
§
Medicare Part
BClaims
Measure
Specifications,
eCQM
Specifications,
MIPSCQM
Specifications
Preventive Care and
Screening: Tobacco Use:
Screening and Cessation
Intervention:
Percentage of patients aged 12
years and older who were
screened for tobacco use one or
more times during the
measurement period AND who
received tobacco cessation
intervention during the
measurement period or in the
six months prior to the
measurement period if
identified as a tobacco user.
Unplanned Hospital
Readmission within 30 Days
of Principal Procedure:
Percentage of patients aged 18
years and older who had an
unplanned hospital readmission
within 30 days of principal
rocedure.
Patient-Centered Surgical
Risk Assessment and
Communication:
Percentage of patients who
underwent a non-emergency
surgery who had their
personalized risks of
postoperative complications
assessed by their surgical team
prior to surgery using a clinical
data-based, patient-specific risk
calculator and who received
personal discussion of those
risks with the su eon.
Closing the Referral Loop:
Receipt of Specialist Report:
Percentage of patients with
referrals, regardless ofage, for
which the referring clinician
receives a report from the
clinician to whom the patient
was referred.
Risk-Adjusted Operative
Mortality for Coronary
Artery Bypass Graft
(CABG):
Percent of patients aged I 8
years and older undergoing
isolated CABG who die,
including both all deaths
occurring during the
hospitalization in which the
CABG was performed, even if
after 30 days, and those deaths
occurring after discharge from
the hospital, but within 30 days
ofthe rocedure.
Screeniug for Social Drivers
of Health:
Percent of patients I 8 years
and older screened for food
insecurity, housing instability,
transportation needs, utility
difficulties, and interpersonal
safe
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62493
B.43. Thoracic Surgery
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!
(Equity)
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PO 00000
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Specifications
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31JYP2
OCHIN
EP31JY24.452
*
Connection to Community
Service Provider:
Percent of patients 18 years or
older who screen positive for
one or more of the following
health related social needs
(HRSNs): food insecurity,
housing instability,
transportation needs, utility
help needs, or interpersonal
safety; and had contact with a
Community Service Provider
(CSP) for at least 1 of their
HRSNs within 60 days after
screenin .
62494
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
8.44. Urgent Care
In addition to the considerations discussed in the introductory language of Table Group B of this Appendix to this proposed rule,
the Urgent Care specialty set takes additional criteria into consideration, which includes, but is not limited to: whether a measure
reflects current clinical guidelines, and the coding of the measure includes relevant clinician types. We may reassess the
appropriateness of individual measures, on a case-by-case basis, to ensure appropriate inclusion in the specialty set. Measure
tables in this set include previously finalized measures we are maintaining within the set, measures proposed to be added, and
measures proposed for removal, as applicable. We request comment on the measures available in the proposed Urgent Care
specialty set.
B.44. Urgent Care
§
!
(Appropria
te Use)
§
!
(Appropria
te Use)
00691
NIA
065
CMSl5
4vl3
eCQM
Specifications,
MIPSCQM
Specifications
Process
NIAi
NIA
066
CMSl4
6vl3
eCQM
Specifications,
MIPSCQM
Specifications
Process
0058 /
NIA
I 16
NIA
MJPSCQM
Specifications
Process
NIAi
NIA
130
CMS68
vl4
eCQM
Specifications,
MlPSCQM
Specifications
Process
CMS13
8vl3
Medicare Part B
Claims Measure
Specifications,
eCQM
Specifications,
MIPSCQM
Specifications
*
§
!
(Patient
Safety)
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§
VerDate Sep<11>2014
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31JYP2
National Committee
for Quality Assurance
National Committee
for QuaIity Assurance
National Committee
for Quality Assurance
Centers for Medicare
& Medicaid Services
National Committee
for Quality Assurance
EP31JY24.453
§
!
(Appropria
te Use)
Appropriate Treatment for
Upper Respiratory Infection
(URI):
Percentage of episodes for
patients 3 months of age and
older with a diagnosis of upper
respiratory infection (URI) that
did not result in an antibiotic
order.
Appropriate Testing for
Pharyngitis:
The percentage of episodes for
patients 3 years and older with
a diagnosis of pharyngitis that
resulted in an antibiotic order
on or within 3 days after the
episode date and a group A
Streptococcus (Strep) test in the
seven-day period from three
days prior to the episode date
through three days after the
e isode date.
Avoidance of Antibiotic
Treatment for Acute
Bronchitis/Bronchiolitis:
The percentage of episodes for
patients ages 3 months and
older with a diagnosis of acute
bronchitis/bronchiolitis that did
not result in an antibiotic
dis ensin event.
Documentation of Current
Medications in the Medical
Record:
Percentage of visits for patients
aged 18 years and older for
which the eligible clinician
attests to documenting a list of
current medications using all
immediate resources available
on the date of the encounter.
Preventive Care and
Screening: Tobacco Use:
Screening and Cessation
lutervention:
Percentage of patients aged 12
years and older who were
screened for tobacco use one or
more times during the
measurement period AND who
received tobacco cessation
intervention during the
measurement period or in the
six months prior to the
measurement period if
identified as a tobacco user.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62495
8.44. Urgent Care
•
!
(Appropria
te Use)
!
(Appropria
te Use)
NIAi
NIA
317
331
CMS22
vl3
Process
NIA
MIPSCQM
Specifications
Process
Process
NIAi
NIA
332
NIA
MIPSCQM
Specifications
2152 I
NIA
431
NIA
MIPSCQM
Specifications
Process
!
(Appropria
le Use)
0657 I
NIA
464
NIA
MIPS CQM
Specifications
Process
!
(Equity)
NIAi
N/A
487
NIA
MIPSCQM
Specifications
Process
§
*
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31JYP2
Centers for Medicare
& Medicaid Services
American Academy of
Otolaryngology - Head
and Neck Surgery
Foundation
American Academy of
Otolaryngology - Head
and Neck Surgery
Foundation
National Committee
for Quality Assurance
American Academy of
Otolaryngology - Head
and Neck Surgery
Foundation
Centers for Medicare
& Medicaid Services
EP31JY24.454
*
Medicare Part B
Claims Measure
Specifications,
eCQM
Specifications,
MIPSCQM
Specifications
Preventive Care and
Screening: Screening for
High Blood Pressure and
Follow-Up Documented:
Percentage of patient visits for
patients aged 18 years and
older seen during the
measurement period who were
screened for high blood
pressure AND a recommended
follow-up plan is documented,
as indicated, if blood pressure
is elevated or h ertensive.
Adult Sinusitis: Antibiotic
Prescribed for Acute Viral
Sinusitis (Overuse):
Percentage of patients, aged 18
years and older, with a
diagnosis of acute viral
sinusitis who were prescribed
an antibiotic within IO days
after onset of s m toms.
Adult Sinusitis: Appropriate
Choice of Antibiotic:
Amoxicillin With or Without
Clavulanate Prescribed for
Patients with Acute Bacterial
Sinusitis (Appropriate Use):
Percentage of patients aged 18
years and older with a
diagnosis of acute bacterial
sinusitis that were prescribed
amoxicillin, with or without
clavulanate, as a first line
antibiotic at the time of
dia nosis.
Preventive Care and
Screening: Unhealthy Alcohol
Use: Screening & Brief
Counseling:
Percentage of patients aged 18
years and older who were
screened for unhealthy alcohol
use using a systematic
screening method at least once
within the last 12 months AND
who received brief counseling
if identified as an unhealthy
alcohol user.
Otitis Media with Effusion:
Systemic Antimicrobials Avoidance of Inappropriate
Use:
Percentage of patients aged 2
months through 12 years with a
diagnosis ofOME who were
not prescribed systemic
antimicrobials.
Screening for Social Drivers
of Health:
Percent of patients 18 years and
older screened for food
insecurity, housing instability,
transportation needs, utility
difficulties, and interpersonal
safe
62496
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
B.44. Urgent Care
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31JYP2
OCHIN
EP31JY24.455
*
Connection to Community
Service Provider:
Percent of patients 18 years or
older who screen positive for
one or more of the following
health related social needs
(HRSNs): food insecurity,
housing instability,
transportation needs, utility
help needs, or interpersonal
safety; and had contact with a
Community Service Provider
(CSP) for at least 1 of their
HRSNs within 60 days after
screenin .
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62497
8.44. Urgent Care
*
NIAi
NIA
488
CM
S95
lv3
eCQM
Specificati
ons,MIPS
CQM
Specificati
ons
Process
Kidney Health
Evaluation:
Percentage of
patients aged 1875 years with a
diagnosis of
diabetes who
received a kidney
health evaluation
defined by an
Estimated
Glomerular
Filtration Rate
(eGFR)AND
Urine AlbuminCreatinine Ratio
(uACR) within
the measurement
period.
National
Kidney
Foundation
We are proposing to include
this measure in the Urgent Care
specialty set as it would be
clinically relevant to this
clinician type. This measure
encourages an estimated
glomerular filtration rate
(eGFR) and urinary albuminto-creatinine ratio ( uACR)
evaluation annually for patients
diagnosed with diabetes. The
measure aims for early
detection which can reduce
associated health risk of the comorbidities of diabetes and
CKD. Having an established
source of care is important in
this high-risk population,
however, in the general US
population, approximately 15
percent of adults do not have a
primary care physicianY 1
According to the American
Diabetes Association annual
assessment of glomerular
filtration rate (GFR) in
adolescents, in addition to
adults, with diabetes is
necessaty to appropriately
screen for early diabetic
nephropathy, and the
assessment of GFR is essential
to accurately diagnose diabetic
kidney disease early in the
disease process. 132 Including
this measure in this specialty
set could assist in capturing atrisk patients who may lack a
rima care h sician.
Toth-Manikowski, S. M., Hsu, J. Y., Fischer, M. J., Cohen, J. B., Lora, C. M., Tan, T. C., He, J., Greer, R. C., Weir, M.
R., Zhang, X., Schrauben, S. J., Saunders, M. R., Ricardo, A. C., Lash, J.P., & Chronic Renal Insufficiency Cohort (CRIC)
Study Investigators (2022). Emergency Department/Urgent Care as Usual Source of Care and Clinical Outcomes in
CKD: Findings From the Chronic Renal Insufficiency Cohort Study. Kidney Medicine, 4(4), 100424.
https://doi.org/10.1016/j.xkme.2022.100424.
132 Bjornstad, P., Cherney, D. Z., & Maahs, D. M. (2015). Update on Estimation of Kidney Function in Diabetic Kidney
Disease. Current Diabetes Reports, 15(9), 57. https://doi.org/10.1007/s11892-015-0633-2.
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62498
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
B.45. Urology
In addition to the considerations discussed in the introductory language of Table Group B of this Appendix to this proposed rule,
the Urology specialty set takes additional criteria into consideration, which includes, but is not limited to: whether a measure
reflects current clinical guidelines, and the coding of the measure includes relevant clinician types. We may reassess the
appropriateness of individual measures, on a case-by-case basis, to ensure appropriate inclusion in the specialty set. Measure
tables in this set include previously finalized measures we are maintaining within the set, measures proposed to be added, and
measures proposed for removal, as applicable. We request comment on the measures available in the proposed Urology specialty
set.
B.45. Urology
...
·
...
•.·
. ·...•.
,. Iri.di.eat()r ••.
•
.
.
.
PREVIOtlSLYFINALIZEDMEASURESINTH.E IJROLOGV SPECIALTY SET
•.. •..
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l
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102
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Specifications,
MIPS CQM
Specifications
20:32 Jul 30, 2024
.
.M~asUr~
Medicare Part
B Claims
Measure
Specifications,
MIPS CQM
Specifications
*
!
(Care
Coordination)
.
.
.
···.
CBE#
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>
·...
.·
.
.•·
•
.
L'
•·
Advance Care Plan:
Percentage of patients aged 65
years and older who have an
advance care plan or surrogate
decision maker documented in
the medical record or
documentation in the medical
record that an advance care
plan was discussed but the
patient did not wish or was
not able to name a surrogate
decision maker or provide an
advance care plan.
Urinary Incontinence:
Assessment of Presence or
Absence of Urinary
Incontinence in Women
Aged 65 Years and Older:
Percentage offemale patients
aged 65 years and older who
were assessed for the presence
or absence of urinary
incontinence within 12
months.
Urinary Incontinence: Plan of
Care for Urinary
Incontinence in Women Aged
65 Years and Older:
Percentage offemale patients
aged 65 years and older with a
diagnosis of urinary
incontinence with a
documented plan of care for
urinary incontinence at least
once within 12 months.
Prostate Cancer: Avoidance
of Overuse of Bone Scan for
Staging Low Risk Prostate
Cancer Patients:
Percentage of patients,
regardless of age, with a
diagnosis of prostate cancer at
low (or very low) risk of
recurrence receiving interstitial
prostate brachytherapy, OR
external beam radiotherapy to
the prostate, OR radical
prostatectomy who did not have
a bone scan performed at any
time since diagnosis of prostate
cancer.
E:\FR\FM\31JYP2.SGM
31JYP2
·.··•·
.·
:.
.• ..
Measure··.
Steward
·..
·•·
..
.
·.
.·
National
Committee
for Quality
Assurance
National
Committee
for Quality
Assurance
National
Committee
for Quality
Assurance
Centers for
Medicare &
Medicaid
Services
EP31JY24.457
•
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62499
B.45. Urology
§
!
(Patient
Safety)
§
§
•
!
(Patient
Safety)
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VerDate Sep<11>2014
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134
CMS68vl4
CMS2vl4
eCQM
Specifications,
MIPSCQM
Specifications
Medicare Part
BClaims
Measure
Specifications,
eCQM
Specifications,
MIPSCQM
Specifications
Process
Process
NIAi
NIA
226
CMS138vl3
Medicare Part
BClaims
Measure
Specifications,
eCQM
Specifications,
MIPSCQM
Specifications
00221
NIA
238
CMS156v13
eCQM
Specifications,
MIPSCQM
Specifications
Process
CMS22vl3
Medicare Part
BClaims
Measure
Specifications,
eCQM
Specifications,
MIPSCQM
Specifications
Process
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Centers for
Medicare&
Medicaid
Services
Centers for
Medicare&
Medicaid
Services
National
Committee for
Quality
Assurance
National
Committee for
Quality
Assurance
Centers for
Medicare&
Medicaid
Services
EP31JY24.458
*
Documentation of Current
Medications in the Medical
Record:
Percentage of visits for
patients aged 18 years and
older for which the eligible
clinician attests to
documenting a list of current
medications using all
immediate resources available
on the date of the encounter.
Preventive Care and
Screening: Screening for
Depression and Follow-Up
Plan:
Percentage of patients aged 12
years and older screened for
depression on the date of the
encounter or up to 14 days
prior to the date of the
encounter using an ageappropriate standardized
depression screening tool
AND if positive, a follow-up
plan is documented on the
date of or up to two days after
the date of the qualifying
encounter.
Preventive Care and
Screening: Tobacco Use:
Screening and Cessation
Intervention:
Percentage of patients aged 12
years and older who were
screened for tobacco use one
or more times during the
measurement period AND
who received tobacco
cessation intervention during
the measurement period or in
the six months prior to the
measurement period if
identified as a tobacco user.
Use of High-Risk
Medications in Older
Adults:
Percentage of patients 65
years of age and older who
were ordered at least two
high-risk medications from
the same dru class.
Preventive Care and
Screening: Screening for
High Blood Pressure and
Follow-Up Documented:
Percentage of patient visits for
patients aged 18 years and
older seen during the
measurement period who
were screened for high blood
pressure AND a
recommended follow-up plan
is documented, as indicated, if
blood pressure is elevated or
h ertensive.
62500
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
8.45. Urology
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CMS-approved
Survey Vendor
Patient
Engagement/
Experience
358
NIA
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Process
374
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eCQM
Specifications,
MIPS CQM
Specifications
Process
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Centers for
Medicare &
Medicaid
Services
American
College of
Surgeons
Centers for
Medicare &
Medicaid
Services
EP31JY24.459
§
CARPS for MIPS
Clinician/Group Survey:
The Consumer Assessment of
Healthcare Providers and
Systems (CAHPS) for MIPS
Clinician/Group Survey is
comprised of 10 Summary
Survey Measures (SSMs) and
measures patient experience
of care within a group
practice. The CBE
endorsement status and
endorsement id (if applicable)
for each SSM utilized in this
measure are as
follows:
• Getting Timely Care,
Appointments, and
Information; (Not endorsed by
CBE)
• How well Providers
Communicate; (Not endorsed
by CBE)
• Patient's Rating of Provider;
(CBE endorsed# 0005)
• Access to Specialists; (Not
endorsed by CBE)
• Health Promotion and
Education; (Not endorsed by
CBE)
• Shared Decision-Making;
(Not endorsed by CBE)
• Health Status and Functional
Status; (Not endorsed by
CBE)
• Courteous and Helpful
Office Staff; (CBE endorsed#
0005)
• Care Coordination; (Not
endorsed by CBE)
• Stewardship of Patient
Resources. (Not endorsed by
CBE)
Patient-Centered Surgical
Risk Assessment and
Communication:
Percentage of patients who
underwent a non-emergency
surgery who had their
personalized risks of
postoperative complications
assessed by their surgical
team prior to surgery using a
clinical data-based, patientspecific risk calculator and
who received personal
discussion of those risks with
the sur eon.
Closing the Referral Loop:
Receipt of Specialist Report:
Percentage of patients with
referrals, regardless of age, for
which the referring clinician
receives a report from the
clinician to whom the patient
was referred.
62501
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
B.45. Urology
\
.
.
lndkato~
§
*
!
(Outcome)
§
!
(Appropriate
Use)
§
!
(Appropriate
Use)
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*
VerDate Sep<11>2014
r
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•
•
.
.\
.
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.
.
•.•...
••.·
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M~sure Title
C~lfottiOJI
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Type)
and l)e~\:rij)ti~11 •
•·.
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CBE#
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...
Preventive Care and
Screening: Unhealthy
Alcohol Use: Screening &
Brief Counseling:
Percentage of patients aged 18
National
years and older who were
MIPS CQM
21521
Committee
431
NIA
Process
screened for unhealthy
Specifications
for Quality
NIA
alcohol use using a systematic
Assurance
screening method at least once
within the last 12 months
AND who received brief
counseling if identified as an
unhealthy alcohol user.
Proportion of Patients
Sustaining a Bladder lnj ury
at the Time of any Pelvic
Organ Prolapse Repair:
American
MIPS CQM
NIAi
Percentage of patients
Urogyneco432
NIA
Outcome
NIA
Specifications
undergoing pelvic organ
logic Society
prolapse repairs who sustain
an injury to the bladder
recognized either during or
within 30 days after surgery.
Percentage of Patients Who
Died from Cancer Receiving
Systemic Cancer-Directed
Therapy in the Last 14 Days
American
of Life (lower score Society of
02101
MIPS CQM
Process
better):
453
NIA
NIA
Specifications
Clinical
Percentage of patients who
Oncology
died from cancer receiving
systemic cancer-directed
therapy in the last 14 days of
life.
Percentage of Patients Who
Died from Cancer Admitted
to Hospice for Less than 3
American
MIPS CQM
days (lower score - better):
Society of
02161
457
NIA
Process
NIA
Specifications
Percentage of patients who
Clinical
died from cancer, and
Oncology
admitted to hospice and spent
less than 3 davs there.
Bone Density Evaluation for
Patients with Prostate
Cancer and Receiving
Androgen Deprivation
Therapy:
Patients determined as having
prostate cancer who are
currently starting or
Oregon
NIA I
eCQM
462
CMS645v8
Process
undergoing androgen
Urology
NIA
Specifications
deprivation therapy (ADT),
Institute
for an anticipated period of 12
months or greater and who
receive an initial bone density
evaluation. The bone density
evaluation must be prior to the
start of ADT or within 3
months of the start of ADT.
CBE#
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62502
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
B.45. Urology
476
CMS77lv6
eCQM
Specifications
NIAi
NIA
481
CMS646v5
eCQM
Specifications
Process
!
(Equity)
NIAi
NIA
487
NIA
MIPSCQM
Specifications
Process
*
NIAi
NIA
488
CMS95lv3
eCQM
Specifications,
MIPSCQM
Specifications
Process
NIAi
NIA
498
NIA
!
(Outcome)
!
(Appropriate
Use)
*
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31JYP2
Large
Urology
Group
Practice
Association
and Oregon
Urology
Institute
Oregon
Urology
Centers for
Medicare&
Medicaid
Services
National
Kidney
Foundation
OCHTN
EP31JY24.461
NIAi
NIA
PatientReported
OutcomeBased
Performance
Measure
Urinary Symptom Score
Change 6-12 Months After
Diagnosis of Benign
Prostatic Hyperplasia:
Percentage of patients with an
office visit within the
measurement period and with
a new diagnosis of clinically
significant Benign Prostatic
Hyperplasia who have
International Prostate
Symptoms Score (!PSS) or
American Urological
Association (AUA) Symptom
Index (ST) documented at time
of diagnosis and again 6-12
months later with an
im rovement of 3 ints.
Intravesical BacillusCalmette Guerin for NonMuscle Invasive Bladder
Cancer:
Percentage of patients initially
diagnosed with non-muscle
invasive bladder cancer and
who received intravesical
Bacillus-Calmette-Guerin
(BCG) within 6 months of
bladder cancer sta in .
Screening for Social Drivers
of Health:
Percent of patients 18 years
and older screened for food
insecurity, housing instability,
transportation needs, utility
difficulties, and interpersonal
safe
Kidney Health Evaluation:
Percentage of patients aged
18-75 years with a diagnosis
of diabetes who received a
kidney health evaluation
defined by an Estimated
Glomerular Filtration Rate
(eGFR) AND Urine AlbuminCreatinine Ratio (uACR)
within the measurement
riod.
Connection to Community
Service Provider:
Percent of patients 18 years or
older who screen positive for
one or more of the following
health related social needs
(HRSNs): food insecurity,
housing instability,
transportation needs, utility
help needs, or interpersonal
safety; and had contact with a
Community Service Provider
(CSP) for at least 1 of their
HRSNs within 60 days after
screenin .
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62503
8.45. Urology
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Insignia
Health, LLC,
a wholly
owned
subsidiary of
Phreesia
EP31JY24.462
*
PatientReported
OutcomeBased
Performance
Measure
Gains in Patient Activation
Measure (PAM®) Scores at
12 Months:
The Patient Activation
Measure® (PAM®) is a 10or 13 - item questionnaire that
assesses an individual's
knowledge, skills and
confidence for managing their
health and health care. The
measure assesses individuals
on a 0-100 scale that converts
to one of four levels of
activation, from low (I) to
high (4). The PAM®
performance measure
(PAM®-PM) is the change in
score on the PAM® from
baseline to follow-up
measurement.
62504
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
8.45. Urology
133
134
VerDate Sep<11>2014
TBD
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Process
Centers
for
Medicare
&
Medicaid
Services
See footnote lkeokwu et al., 2023 in Table B.l of this Appendix.
See footnotes Fitzpatrick et al., 2022; Polack et al., 2020; and Grana et al., 2022 in Table A.5 of this Appendix.
20:32 Jul 30, 2024
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lotter on DSK11XQN23PROD with PROPOSALS2
NIAi
NIA
MIPS
CQM
Specificati
ons
Adult COVID19 Vaccination
Status:
Percentage of
patients aged 18
years and older
seen for a visit
during the
performance
period that are up
to date on their
COVID-19
vaccinations as
defined by CDC
recommendation
son current
vaccination.
We are proposing to include this
measure in the Urology specialty
set as it would be clinically
relevant to this clinician type.
Widespread vaccination against
SARS-CoV-2, the virus that
causes COVID-19, is critically
important to stemming the
morbidity and mortality caused by
this disease. 133 Clinicians are
uniquely positioned to encourage
uptake of COVID-19 vaccination,
and clinicians are still a major
driving force in promoting patient
vaccination. The addition of this
quality measure in this specialty
set would help strengthen
compliance with recommended
COVID-19 vaccination, leading to
improvement in the quality of
patient care and prevention of
disease for the general population.
This quality measure aligns with
clinical guidelines and the
evidence-based recommendations
of the ACIP, where there is
general agreement about the
safety and efficacy of the
COVTD-19 vaccine, preventing
costly and potentially harmful
hospitalizations. 134 Broadening
vaccination status awareness to
this clinician type is valuable as it
can help drive an increase in the
adult vaccination rates. The
COVID-19 vaccination included
within this measure would reduce
the prevalence of severe diseases
that may he associated with
hospitalization and decrease
overall health care costs. The
measure being added to this
specialty set would he contingent
on the inclusion ofapplicable
coding by the time of the CY
2025 PFS fmal rule. In the event
appropriate coding is not included
in the final specification, this
measure would not be fmalized
for inclusion within this specialty
measure set. See Table A.5 of this
Appendix for rationale, including
clinical evidence supporting the
inclusion of this measure in
MIPS.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62505
B.45. Urology
PREVlotJSLY FlNAUZ.EOMEASURES rao.ros'Eo FOR·REMOVALFROM l'HE UROLOGY sr.ec1ALTYSJn'
Note: Tl) this proposed role, we ire µropo~ing: the remo~al of the fol]6\vihg measure(s) b.elow from this specific spepialty ~easur~ set based ..•
upon .review of \lpdate$ inade.to. existing quaJ.ity m~asui-e sp~ifications, .the propq~ed add(tl()U 2014
104
433
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MIPS CQM
Specifications
MIPS CQM
Specifications
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American
Urological
Association
Education and
Research
American
Urogynecologic
Society
E:\FR\FM\31JYP2.SGM
31JYP2
This measure is being
proposed for removal
beginning with the CY
2025 performance
periodl2027 MIPS
payment year. See Table
Group C for rationale.
This measure is being
proposed for removal
beginning with the CY
2025 performance
periodl2027 MIPS
payment year. See Table
Group C for rationale.
EP31JY24.464
NIAi
Prostate Cancer:
Combination Androgen
Deprivation Therapy for
High Risk or Very High
Risk Prostate Cancer:
Percentage of patients,
regardless of age, with a
diagnosis of prostate cancer
at high or very high risk of
recurrence receiving
external beam radiotherapy
to the prostate who were
prescribed androgen
deprivation therapy in
combination with external
beam radiotherapy to the
rostate.
Proportion of Patients
Sustaining a Bowel Injury
at the time of any Pelvic
Organ Prolapse Repair:
Percentage of patients
undergoing surgical repair
of pelvic organ prolapse that
is complicated by a bowel
injury at the time of index
surgery that is recognized
intraoperatively or within 30
da s after sur e .
62506
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
B.46. Vascular Surgery
In addition to the considerations discussed in the introductory language of Table Group B of this Appendix to this proposed rule,
the Vascular Surgery specialty set takes additional criteria into consideration, which includes, but is not limited to: whether a
measure reflects current clinical guidelines, and the coding of the measure includes relevant clinician types. We may reassess the
appropriateness of individual measures, on a case-by-case basis, to ensure appropriate inclusion in the specialty set. Measure
tables in this set include previously finalized measures we are maintaining within the set, measures proposed to be added, and
measures proposed for removal, as applicable. We request comment on the measures available in the proposed Vascular Surgery
specialty set.
B.46. Vascular Surgery
!
(Care
Coordinatio
n)
047
NIA
NIAi
NIA
130
CMS
68v14
eCQM
Specifications,
MIPS CQM
Specifications
Process
CMS
138vl
3
Medicare Part
B Claims
Measure
Specifications,
eCQM
Specifications,
MIPS CQM
Specifications
Process
CMS
165vl
3
Medicare Part
B Claims
Measure
Specifications,
eCQM
Specifications,
MIPS CQM
Specifications
Intermediate
Outcome
*
§
!
(Patient
Safety)
NIAi
NIA
§
*
§
NIAi
NIA
226
236
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National Committee
for Quality
Assurance
Centers for Medicare
& Medicaid Services
National Committee
for Quality
Assurance
National Committee
for Quality
Assurance
EP31JY24.465
0326 I
NIA
Medicare Part
B Claims
Measure
Specifications,
MIPS CQM
Specifications
*
Advance Care Plan:
Percentage of patients aged 65
years and older who have an
advance care plan or surrogate
decision maker documented in
the medical record or
documentation in the medical
record that an advance care plan
was discussed but the patient did
not wish or was not able to
name a surrogate decision maker
or rovide an advance care Ian.
Documentation of Current
Medications in the Medical
Record:
Percentage of visits for patients
aged 18 years and older for
which the eligible clinician
attests to documenting a list of
current medications using all
immediate resources available
on the date of the encounter.
Preventive Care and
Screening: Tobacco Use:
Screening and Cessation
Intervention:
Percentage of patients aged 12
years and older who were
screened for tobacco use one or
more times during the
measurement period AND who
received tobacco cessation
intervention during the
measurement period or in the six
months prior to the
measurement period if identified
as a tobacco user.
Controlling High Blood
Pressure:
Percentage of patients 18-85
years ofage who had a
diagnosis of essential
hypertension starting before and
continuing into, or starting
during the first six months of the
measurement period, and whose
most recent blood pressure was
adequately controlled
(<140190mmHg) during the
measurement eriod.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62507
B.46. Vascular Surgery
259
NIA
MIPSCQM
Specifications
Outcome
Process
*
NIAi
NIA
317
CMS
22vl3
Medicare Part
BClaims
Measure
Specifications,
eCQM
Specifications,
MIPSCQM
Specifications
*
NIAi
NIA
344
NIA
MIPSCQM
Specifications
Outcome
!
(Outcome)
NIAi
NIA
357
NIA
MIPSCQM
Specifications
Outcome
!
(Patient
Experience)
NIAi
NIA
358
NIA
MIPSCQM
Specifications
Process
*
!
(Care
Coordinatio
n)
NIAi
NIA
374
CMS
50v13
eCQM
Specifications,
MIPSCQM
Specifications
Process
!
(Outcome)
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31JYP2
Society for Vascular
Surgeons
Centers for Medicare
& Medicaid Services
Society for Vascular
Surgeons
American College of
Surgeons
American College
of Surgeons
Centers for
Medicare &
Medicaid Services
EP31JY24.466
!
(Outcome)
Rate of Endovascular
Aneurysm Repair (EVAR) of
Small or Moderate NonRuptured Infrarenal
Abdominal Aortic Aneurysms
(AAA) without Major
Complications (Discharged to
Home by Post Operative Day
#2):
Percent of patients undergoing
endovascular repair of small or
moderate non-ruptured
infrarenal abdominal aortic
aneurysms (AAA) that do not
experience a major complication
(discharged to home no later
than ost-o erative da #2.
Preventive Care and
Screening: Screening for High
Blood Pressure and Follow-Up
Documented:
Percentage of patient visits for
patients aged 18 years and older
seen during the measurement
period who were screened for
high blood pressure AND a
recommended follow-up plan is
documented, as indicated, if
blood pressure is elevated or
h ertensive.
Rate of Carotid Artery
Stenting (CAS) for
Asymptomatic Patients,
Without Major Complications
(Discharged to Home by PostOperative Day #2):
Percent of asymptomatic
patients undergoing CAS who
are discharged to home no later
than ost-o erative da #2.
Surgical Site Infection (SSI):
Percentage of patients aged 18
years and older who had a
sur ical site infection SSI .
Patient-Centered Surgical
Risk Assessment and
Communication:
Percentage of patients who
underwent a non-emergency
surgery who had their
personalized risks of
postoperative complications
assessed by their surgical team
prior to surgery using a clinical
data-based, patient-specific risk
calculator and who received
personal discussion of those
risks with the sur eon.
Closing the Referral Loop:
Receipt of Specialist Report:
Percentage of patients with
referrals, regardless of age, for
which the referring clinician
receives a report from the
clinician to whom the patient
was referred.
62508
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
B.46. Vascular Surgery
!
(Outcome)
§
!
(Outcome)
!
(Equity)
*
!
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(Equity)
VerDate Sep<11>2014
NIAi
NIA
420
NIA
MIPS CQM
Specifications
NIAi
NIA
441
NIA
MIPS CQM
Specifications
Intermediate
Outcome
NIAi
NIA
487
NIA
MIPS CQM
Specifications
Process
NIAi
NIA
498
NIA
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31JYP2
Society of
Interventional
Radiology
Wisconsin
Collaborative for
Healthcare Quality
Centers for
Medicare &
Medicaid Services
OCHIN
EP31JY24.467
*
PatientReported
OutcomeBased
Performance
Measure
Varicose Vein Treatment with
Saphenous Ablation: Outcome
Survey:
Percentage of patients treated
for varicose veins (CEAP C2-S)
who are treated with saphenous
ablation (with or without
adjunctive tributary treatment)
that report an improvement on a
disease specific patient reported
outcome survey instrument after
treatment.
Ischemic Vascular Disease
(IVD) All or None Outcome
Measure (Optimal Control):
The IVD All-or-None Measure
is one outcome measure
(optimal control). The measure
contains four goals. All four
goals within a measure must be
reached in order to meet that
measure. The numerator for the
all-or-none measure should be
collected from the organization's
total IVD denominator. All-orNone Outcome Measure
(Optimal Control) - Using the
IVD denominator optimal
results include:
• Most recent blood pressure
(BP) measurement is less than
or equal to 140190 mm Hg -AND
• Most recent tobacco status is
Tobacco Free -- AND
• Daily Aspirin or Other
Antiplatelet Unless
Contraindicated -- AND
• Statin Use Unless
Contraindicated.
Screening for Social Drivers of
Health:
Percent of patients 18 years and
older screened for food
insecurity, housing instability,
transportation needs, utility
difficulties, and interpersonal
safe
Connection to Community
Service Provider:
Percent of patients 18 years or
older who screen positive for
one or more of the following
health related social needs
(HRSNs): food insecurity,
housing instability,
transportation needs, utility help
needs, or interpersonal safety;
and had contact with a
Community Service Provider
(CSP) for at least 1 of their
HRSNs within 60 days after
screenin .
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62509
B.46. Vascular Surgery
PllEYJO~SI,;fFlNALIZ~DJ\tEASUJµ:SPROP~Sil)F.()RIUJ;MOVALFROJM'fHEVM¢llLAR~UR.GER\I
SPECIALTY SET
N()te; liHllis propo,s~drtth\ \\I~ ll,ff propo~ingt!ie remoyal ofthe foll~wing rne~sure{~}.b~fowfroi:n thisspecific ~pectalty measure set based
11pon nwiew.;of update~ 111ad~ w.ex.isting.q11ality. me~sure specifications; tJie prop9$ed additjo!l of new measures .for inclusion in MtpS, rmd .tlte
feedback rovided.b s ecial societies..
•
••
•
•
c.nE#
I
e<'.:QM
CBE#
NA/
NA
260
NIA
MIPS CQM
Specification
Outcome
Rate of Carotid
Endarterectomy (CEA) for
Asymptomatic Patients,
without Major
Complications (Discharged
to Home by PostOperative Day #2):
Percent of asymptomatic
patients undergoing Carotid
Endarterectomy (CEA) who
are discharged to home no
later than post-operative day
#2.
Society for
Vascular
Surgeons
This measure is being
proposed for removal
beginning with the CY
2025 performance
period/2027 MIPS
payment year. See Table
Group C for rationale.
Table Group C: Previously Finalized Quality Measures Proposed for Removal for the CY
2025 Performance Period/2027 MIPS Payment Year and Future Years
In this proposed rule, we are proposing to remove 11 previously finalized MIPS quality measures for the CY 2025 performance
period/2027 MIPS payment year and future years which are discussed in detail in the removal tables below. We note measure
Q436: Radiation Consideration for Adult CT: Utilization of Dose Lowering Techniques was already finalized for removal with a
I-year delay to the CY 2025 performance period as noted in the Table Group B introduction (88 FR 79896); therefore, measure
Q436 does not have a removal table in this proposed rule and there are 10 removal tables under Table Group C.
The CY 2019 PFS final rule (83 FR 59763 through 59765) and CY 2020 PFS final rule (84 FR 62957 through 62959) discusses
our incremental approach to removing process measures.
Under our measure removal criteria, consideration is given to the following, but is not limited to:
•
Whether the removal of the process measure impacts the number of measures available for a specific specialty.
•
Whether the measure addresses a priority area highlighted in the Measure Development Plan at
https:/lwww.cms.gov/Medicare/Quality-Payment-Program/Measure-Development/Measure-development.
•
Whether the measure promotes positive outcomes in patients.
•
Considerations and evaluation of the measure's performance data.
•
Whether the measure is designated as high priority or not.
If they do not meet case minimum and reporting volumes required for benchmarking after being in the program
•
for two consecutive CY performance periods.
•
After factoring in other considerations (such as, but not limited to: the robustness of the measure; whether it
addresses a measurement gap; if the measure is a patient-reported outcomes; consideration of the measure in
developing MVPs).
If we determine the measure is not available for MIPS reporting by or on behalf of all MIPS eligible clinicians.
•
Further considerations are given in the evaluation of the measure's performance data to determine whether there is or no longer is
variation in performance. As discussed in the CY 2019 PFS final rule (83 FR 59761 through 59763), an additional criterion we
use for the removal of measures includes extremely topped-out measures, which refers to measures topped out with an average
(mean) performance rate between 98-100 percent.
EP31JY24.469
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For a measure proposed for removal due to criteria relating to the benchmark and performance data, further information
regarding 2024 MIPS benchmarking data can be located at https:llqpp.cms.gav/benchmarks.
62510
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
C.t. Prostate Cancer: Combination Androeen Deorivation Theranv for Hieh Risk or Verv Hieh Risk Prostate Cancer
Category
CBE# I eCQM CBE #:
Quality#:
CMSeCQMID:
Collection Tvpe:
Measure Description:
Description
N/A/N/A
104
N/A
MIPS CQM Specifications
Percentage of patients, regardless of age, with a diagnosis of prostate cancer at high or
very high risk of recurrence receiving external beam radiotherapy to the prostate who
were prescribed androgen deprivation therapy in combination with external beam
radiotherapy to the prostate.
American Urological Association Education and Research
No
Process
We are proposing the removal of this quality measure from MIPS (finalized in 81 FR
77558 through 77675) because the limited patient population as well as adoption of this
quality measure does not allow for the creation of a benchmark. For more information on
benchmarks, see the MIPS 2024 Quality Benchmarks User Guide
Measure Steward:
High Prioritv Measure:
Measure Type:
Rationale for Removal:
https:llwww.cms.gov/files/document/2024-qua/ity-benchmarks-user-guide-scoringexamples-pdfpdf The current 2024 MIPS benchmarking data is located at
httf)s :IIann. cms.52014
20:32 Jul 30, 2024
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N/A/N/A
137
N/A
MIPS CQM Specifications
Percentage of patients, regardless of age, with a current diagnosis of melanoma or a
history of melanoma whose information was entered, at least once within a 12 month
period, into a recall system that includes:
• A target date for the next complete physical skin exam, AND
• A process to follow up with patients who either did not make an appointment within the
specified timeframe or who missed a scheduled appointment.
American Academy of Dermatology
Yes
Structure
We are proposing the removal of this quality measure from MIPS (finalized in 81 FR
77558 through 77675) because this measure is duplicative of the Melanoma: Tracking and
Evaluation of Recurrence measure being proposed in Table A.6 of this Appendix.
Measure Q 13 7 establishes a recall system linked to the process of notifying patients, with
a current diagnosis or history of melanoma, when their next physical exam is due, as well
as to follow up with patients who did not make an appointment within the specified
timeframe or who missed a scheduled appointment. It does not assess whether the patient
completed an annual skin exam nor if the process to follow up for those patients who
missed an appointment is effective. The new measure proposed in Table A.6 of this
Appendix is a process measure that not only assesses a significantly similar patient
population, but also assesses patients who had excisional surgery for melanoma or
melanoma in situ in the past 5 years for completion of an exam and/or diagnosed for
recurrence of melanoma. We believe the new measure provides a more meaningful impact
to quality improvement for this patient population.
There are no substantive changes or specialty set movement proposed for this measure. If
the measure is not finalized for removal in the CY 2025 PFS final rule, it would be added
back into the applicable previously finalized specialty set(s) under Table Group B of this
Appendix and the reason for its retention would be addressed under Table Group C of this
Appendix.
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CBE# I eCQM CBE #:
Quality#:
CMSeCQMID:
Collection Tvpe:
Measure Description:
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62511
C3
.. 0 nco 02:: Md.
e 1ca I an dRad.18t'I0n- Planore are tior p.
am
Catee:orv
CBE# / eCQM CBE #:
Quality#:
CMSeCQMID:
Collection Type:
Measure Description:
Measure Steward:
Hi!!h Prioritv Measure:
Measure Type:
Rationale for Removal:
In the Circumstance the Measure Was
Retained:
Description
0383 /N/A
144
NIA
MIPS CQM Specifications
Percentage of visits for patients, regardless of age, with a diagnosis of cancer currently
receiving chemotherapy or radiation therapy who report having pain with a documented
plan of care to address pain.
American Societv of Clinical Oncology
Yes
Process
We are proposing the removal of this quality measure from MIPS (finalized in 81 FR
77558 through 77675) because this measure is duplicative of measure Q143: Oncology:
Medical and Radiation- Pain Intensity Quantified. Measure Ql43 specifically questions
cancer patients, currently receiving chemotherapy or radiation therapy, to quantify their
pain intensity at each visit using a standardized tool. This measure is more robust than
measure Q 144 as it encourages the clinician to initiate a discussion regarding pain
intensity with the patient at every denominator eligible visit. Measure Q 144 is narrower in
scope focusing on cancer patients identified with pain. To identify this patient population,
a clinician would still need to screen their patients. Measure Q 143 promotes screening of a
broader patient population for pain, which still allows clinicians to administer care if pain
is present. Additionally, measure Ql43 is available for reporting within the eCQM
Specifications collection type, allowing clinicians more measure options if reporting via
eCQMs.
There are no substantive changes or specialty set movement proposed for this measure. If
the measure is not finalized for removal in the CY 2025 PFS final rule, it would be added
back into the applicable previously finalized specialty set(s) under Table Group B of this
Appendix and the reason for its retention would be addressed under Table Group C of this
Appendix.
C.4. Ultrasound Determination of Pre2nancv Location for Pre2nant Patients with Abdominal Pain
Cate2ory
Description
CBE# / eCQM CBE #:
NIA/NIA
Qualitv#:
254
CMScCQMID:
NIA
Collection Tvpe:
MIPS COM Specifications
Measure Description:
Percentage of pregnant female patients aged 14 to 50 who present to the emergency
department (ED) with a chief complaint ofabdominal pain or vaginal bleeding who
receive a trans-abdominal or trans-vaginal ultrasound to determine oregnancv location.
Measure Steward:
American Colle2e ofEmernencv Phvsicians
Hi2h Priority Measure:
No
Measure Tvne:
Process
We are proposing the removal of this quality measure from MIPS (finalized in 81 FR
Rationale for Removal:
77558 through 77675) because this measure has reached the end of the topped-out
lifecycle (82 FR 53640) and has a limited opportunity to improve clinical outcomes.
Topped-out process measures are those with a median performance rate of95 percent or
higher (81 FR 77286). 135 This measure's continued topped-out status is based on the
current 2024 MIPS benchmarking data located at https:llqpp.cms.govlbenchmarks, in
addition to previous years MIPS benchmarking data. For more information on
benchmarks, see the MIPS 2024 Quality Benchmarks User Guide at
https:llwww.cms.gov/filesldocumenl/2024-quality-benchmarks-user-guide-scoringexamples-pdfr;df.
In the Circumstance the Measure Was
There are no substantive changes or specialty set movement proposed for this measure. If
Retained:
the measure is not finalized for removal in the CY 2025 PFS final rule, it would be added
back into the applicable previously finalized specialty set(s) under Table Group B of this
Appendix and the reason for its retention would be addressed under Table Group C of this
Appendix.
135 See the 2024 MIPS Call for Measures Fact Set: https://qpp-cm-prodcontent.s3.amazonaws.com/uploads/2711/2024-MIPS-Call-for-Measures-and-Activities.zip.
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C.5. Rate of Carotid Endarterectomy (CEA) for Asymptomatic Patients, without Major Complications (Discharged to
Home b Post-O erative Da #2 :
Cate orv
Descri tion
N/A/N/A
CBE# / eCQM CBE #:
62512
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
Category
Quality#:
CMSeCQMID:
Collection Tvpe:
Measure Description:
Measure Steward:
High Priority Measure:
Measure Tvpe:
Rationale for Removal:
In the Circumstance the Measure Was
Retained:
Description
260
NIA
MIPS CQM Specifications
Percent of asymptomatic patients undergoing Carotid Endarterectomy (CEA) who are
discharged to home no later than post-operative day #2.
Society for Vascular Surgeons
Yes
Outcome
We are proposing the removal of this quality measure from MIPS (finalized in 81 FR
77558 through 77675) because this measure would be duplicative of measure Q344: Rate
of Carotid Artery Stenting (CAS) for Asymptomatic Patients, Without Major
Complications (Discharged to Home by Post-Operative Day #2) if the proposed changes
to the measure are finalized. We are proposing in Table D.34 of this Appendix substantive
changes to measure Q344, which describe the inclusion of the measure concept
represented in Q260. Measure Q260 is focused on performing CEA on asymptomatic
patients who are at low risk for morbidity and therefore are expected to have very low
complication rates as indicated by patients being discharged to home by post-operative
day #2. As a result, we are proposing to maintain measure Q344 and remove measure
0260 from MIPS.
There are no substantive changes or specialty set movement proposed for this measure. If
the measure is not finalized for removal in the CY 2025 PFS final rule, it would be added
back into the applicable previously finalized specialty set(s) under Table Group B of this
Appendix and the reason for its retention would be addressed under Table Group C of this
Aooendix.
C.6. Clinical Outcome Post Endovascular Stroke Treatment
Measure Steward:
Hil!h Priority Measure:
Measure Tvne:
Rationale for Removal:
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In the Circumstance the Measure Was
Retained:
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Description
NIA/NIA
409
NIA
MIPS CQM Soecifications
Percentage of patients with a Modified Rankin Score (mRS) score of0 to 2 at 90 days
following endovascular stroke intervention.
Society of Interventional Radiology
Yes
Outcome
We are proposing the removal of this quality measure from MIPS (finalized in 81 FR
77558 through 77675) at the measure steward's request as it is no longer being maintained
for inclusion.
There are no substantive changes or specialty set movement proposed for this measure. If
the measure is not finalized for removal in the CY 2025 PFS final rule, it would be added
back into the applicable previously finalized specialty set(s) under Table Group B of this
Appendix and the reason for its retention would be addressed under Table Group C of this
Appendix.
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CBE# I eCQM CBE #:
Quality#:
CMSeCQMID:
Collection Tvoe:
Measure Description:
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62513
C.7. Proportion of Patients Sustainin2: a Bowel Iniurv at the time ofanv Pelvic Or2:an Prolapse Repair
Catei:wrv
CBE# I eCQM CBE #:
Quality#:
CMSeCQMID:
Collection Type:
Measure Description:
Descriotion
NIA/NIA
433
N/A
MIPS CQM Specifications
Percentage of patients undergoing surgical repair of pelvic organ prolapse that is
complicated by a bowel injury at the time of index surgery that is recognized
intraoperativelv or within 30 davs after surgerv.
American Urogvnecologic Society
Yes
Outcome
We are proposing the removal of this quality measure from MIPS (finalized in 81 FR
77558 through 77675) because this measure would be duplicative of measure Q432:
Proportion of Patients Sustaining a Bladder Injury at the Time of any Pelvic Organ
Prolapse Repair, if the proposed changes to the measure are finalized. We are proposing in
Table D.46 of this Appendix substantive changes to measure Q432, which describe the
inclusion of the measure concept represented in measure Q433. ln addition, we are
proposing to update the measure title and description for measure Q432 to include patients
who sustain a bowel iniurv at the time of anv oelvic organ orolaose reoair.
There are no substantive changes or specialty set movement proposed for this measure. If
the measure is not finalized for removal in the CY 2025 PFS final rule, it would be added
back into the applicable previously finalized specialty set(s) under Table Group B of this
Appendix and the reason for its retention would be addressed under Table Group C of this
Appendix.
Measure Steward:
High Prioritv Measnre:
Measure Tvoe:
Rationale for Removal:
In the Circumstance the Measure Was
Retained:
C.8. Age Appropriate Screening Colonoscopy
Measure Steward:
High Prioritv Measure:
Measure Tvoe:
Rationale for Removal:
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In the Circumstance the Measure Was
Retained:
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Description
NIA/NIA
439
NIA
MIPS CQM Specifications
The percentage of screening colonoscopies performed in patients greater than or equal to
86 years of age from Januarv I to December 31.
American Gastroenterological Association
Yes
Efficiency
We are proposing the removal of this quality measure from MIPS (finalized in 81 FR
77558 through 77675) because the quality action being measured has become standard of
care, based upon MIPS performance data, and thus has limited opportunity to improve
clinical outcomes. Performance on this measure is extremely high and unvarying, making
this measure extremely topped out as discussed in the CY 2019 PFS final rule ( 83 FR
59761 through 59763). The average performance for this inverse measure is 0.15 percent
for the MIPS CQM Specifications collection type. For an inverse measure, a lower
calculated performance rate indicates better clinical care or control. As such, the MIPS
CQM Specifications collection type is considered extremely topped out. The average
performance rate is based on the current 2024 MIPS benchmarking data located at
https:l/qpp.cms.gov/benchmarks. For more information on benchmarks, see the MIPS
2024 Quality Benchmarks User Guide at https:l/www.cms.govijiles/document/2024auafitv-benchmarks-user-£Uide-scorinz-examoles-odfodf
There are no substantive changes or specialty set movement proposed for this measure. If
the measure is not finalized for removal in the CY 2025 PFS final rule, it would be added
back into the applicable previously finalized specialty set(s) under Table Group B of this
Appendix and the reason for its retention would be addressed under Table Group C of this
Appendix.
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CBE# I eCQM CBE #:
Qualitv #:
CMSeCQMID:
Collection Tvpe:
Measure Description:
62514
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
C.9. Patients with Metastatic Colorectal Cancer and RAS (KRAS or NRAS) Gene Mutation Spared Treatment with Antiepidermal Growth Factor Receptor (EGFR) Monoclonal Antibodies
Descrintion
1860/N/A
452
NIA
MIPS COM Soecifications
Percentage of adult patients (aged 18 or over) with metastatic colorectal cancer and RAS
(KRAS or NRAS) gene mutation spared treatment with anti-EGFR monoclonal
antibodies.
American Societv of Clinical Oncology
Yes
Process
We are proposing the removal of this quality measure from MIPS (finalized in 81 FR
77558 through 77675) because this measure is duplicative of measure Q451: RAS (KRAS
and NRAS) Gene Mutation Testing Performed for Patients with Metastatic Colorectal
Cancer who receive Anti-epidermal Growth Factor Receptor (EGFR) Monoclonal
Antibody Therapy. Measures Q451 and Q452 ask the same clinical question but approach
questioning from different clinical perspectives. Measure Q45 l assesses patients who
have already received anti-EGFR monoclonal therapy to determine if they received RAS
gene mutation testing prior to initiation of therapy, while measure Q452 is a standard-ot:
care measure, as well as the counter clinical perspective to measure Q45 l. Measure Q452
only evaluates for patients who received anti-EGFR monoclonal treatment. Therefore,
measure Q452 is a component of the quality action within measure Q45 l. The molecular
biomarkers for the evaluation ofcolorectal cancer guidelines 136 strongly recommend
"Patients with colorectal carcinoma being considered for anti-EGFR therapy must receive
RAS mutational testing," which is the standard of care being evaluated by this measure.
Cate!!orv
CBE# / eCOM CBE #:
Quality#:
CMSeCQMID:
Collection Tvne:
Measure Description:
Measure Steward:
Hi!!h Prioritv Measure:
Measure Tyne:
Rationale for Removal:
In the Circumstance the Measure Was
Retained:
Measure Q45 l provides an opportunity for a retrospective review and has the potential to
improve clinical outcomes. For example, if the performance rates show there is a gap in
medical care or high incidence of initiating therapy without first testing for the RAS gene
mutation, clinical processes can be revised to improve practice. "Clinical care review is
the process of retrospectively examining potential errors or gaps in medical care, with a
goal of future practice improvement." 137
If the measure is not finalized for removal in the CY 2025 PFS final rule, we are
proposing to apply the following substantive changes to the measure specifications: ( 1)
add denominator instructions to clarify the denominator eligible timeframe for diagnosis
and (2) only patients who have been newly diagnosed with Stage IV colorectal cancer, or
patients who have distant metastases at the time of colon cancer diagnosis, are to be
included in the denominator of the measure to ensure the appropriate patient population is
assessed for the numerator action.
If the measure is not finalized for removal in the CY 2025 PFS final rule, it would be
added back into the applicable previously finalized specialty set(s) under Table Group B
and the reason for its retention would be addressed under Table Group C. The substantive
changes outlined above would be applied to the measure soecifications.
Sepulveda, A. R., Hamilton, S. R., Allegra, C. J., Grody, W., Cushman-Vokoun, A. M., Funkhouser, W. K., Kopetz, S.
E., lieu, C., lindor, N. M., Minsky, 8. 0., Monzon, F. A., Sargent, 0. J., Singh, V. M., Willis, J., Clark, J., Colasacco, C.,
Rumble, R. 8., Temple-Smolkin, R., Ventura, C. 8., & Nowak, J. A. (2017). Molecular 8iomarkers for the Evaluation
of Colorectal Cancer: Guideline From the American Society for Clinical Pathology, College of American Pathologists,
Association for Molecular Pathology, and the American Society of Clinical Oncology. Journal of Clinical Oncology:
Official Journal of the American Society of Clinical Oncology, 35(13), 1453-1486.
https://doi.org/10.1200/JC0.2016. 71.9807.
137 Walker, LE., Nestler, o. M., Laack, T. A., Clements, C. M., Erwin, P. J., Scanlan-Hanson, L, & 8ellolio, M. F.
(2018). Clinical Care Review Systems in Healthcare: A Systematic Review. International Journal of Emergency
Medicine, 11(1), 6. https://doi.org/10.1186/s12245-018-0166-y.
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62515
C.10. Appropriate Use of DXA Scans in Women Under 65 Years Who Do Not Meet the Risk Factor Profile for
Osteoporotic Fracture
Measure Steward:
Hi!!h Priority Measure:
Measure Type:
Rationale for Removal:
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In the Circumstance the Measure Was
Retained:
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Description
NIA/ 3475e
472
CMS249v7
eCQM Soecifications
Percentage of female patients 50 to 64 years of age without select risk factors for
osteoporotic fracture who received an order for a dual-energy x-ray absorptiometry
(DXA) scan during the measurement period.
Centers for Medicare & Medicaid Services
Yes
Process
We are proposing the removal of this quality measure from MIPS (finalized in 83 FR
60104 through 60105) because the quality action being measured has become standard of
care, based upon MIPS performance data, and thus has limited opportunity to improve
clinical outcomes. Performance on this measure is extremely high and unvarying, making
this measure extremely topped out as discussed in the CY 2019 PFS final rule (83 FR
59761 through 59763 ). The average performance for this inverse measure is 1.1 percent
for the eCQM Specifications collection type. For an inverse measure, a lower calculated
performance rate indicates better clinical care or control. As such, the eCQM
Specifications collection type is considered extremely topped out. The average
performance rate is based on the current 2024 MIPS benchmarking data located at
https://qpp.cms.gov/benchmarks. For more information on benchmarks, see the MIPS
2024 Quality Benchmarks User Guide at https:/lwww.cms.gov/files/document/2024Qualitv-benchmarks-user-flttide-scorin,;-examvles-vdfvdf
There are no substantive changes or specialty set movement proposed for this measure. If
the measure is not finalized for removal in the CY 2025 PFS final rule, it would be added
back into the applicable previously finalized specialty set(s) under Table Group B of this
Appendix and the reason for its retention would be addressed under Table Group C of this
Aooendix.
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Catel!orv
CBE# I eCQM CBE #:
Qualitv #:
CMSeCQMID:
Collection Tvoe:
Measure Description:
62516
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
Table Group D: Proposed Substantive Changes to Previously Finalized MIPS Quality
Measures for the CY 2025 Performance Period/2027 MIPS Payment Year and Future
Years
The D Tables within this proposed rule provide the substantive changes proposed for the MIPS quality measures in CY 2025. We
note that some MIPS quality measures available in traditional MIPS and MVPs are adopted by the Medicare Shared Savings
Program for utilization in the Alternative Payment Model (APM) Performance Pathway (APP) and/or APP Plus, as proposed in
section IV.A.4.c.(3) of this proposed rule. For such measures, the collection type applicable for purposes of the APP and/or APP
Plus (Medicare CQM for Accountable Care Organizations Participating in the Medicare Shared Savings Program (Medicare
CQM)) is also specified as a collection type available for such measures described in Table Group D.
The changes that are made to the denominator codes sets are generalizations of the revisions communicated from the measure
stewards to CMS. Additionally, International Classification of Diseases Tenth Edition (ICD-10) and Current Procedural
Terminology (CPT) codes that are identified as invalid for CY 2025 may not be identified within this proposed rule due to the
availability of these changes to the public. If coding revisions to the denominator are impacted due to the timing of 2025 CPT and
ICD-10 updates and assessment of these codes' inclusion by the Measure Steward, these changes may be postponed until CY
2025. The 2025 Quality Measure Release Notes provide a comprehensive, detailed reference of exact code changes to the
denominators of the quality measures. The Quality Measure Release Notes are available for each of the collection types in the
Quality Payment Program website at https://qpp.cms.gov. In addition, eCQMs that are endorsed by a CBE are shown in Table D
ofthis Appendix as follows: CBE # / eCQM CBE #.
In addition to the proposed substantive changes, there may be changes to the coding utilized within the denominator that are not
considered substantive in nature, but they are important to communicate to interested parties. These changes align with the scope
of the current coding; however, though not substantive in nature, these changes would expand or contract the measure's current
eligible population. Therefore, please refer to the current year measure specification and the 2025 Quality Measure Release Notes
or the eCQM Technical Release Notes once posted to review all coding changes to ensure correct implementation. Language has
also been added, to all applicable 2025 quality measure specifications, in the form ofan 'Instructions Note' to clarify that
telehealth encounters are allowed for determination of denominator eligibility. Only where telehealth encounters previously were
not allowed as denominator eligible would the D table corresponding to a measure reflect an update to the denominator allowing
for telehealth encounters in the 'Substantive Change' cell.
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The eCQM Technical Release Notes should also be carefully reviewed for revisions within the logic portion of the measure. In
addition to the proposed substantive changes, there may be revisions within the logic that are not considered substantive in
nature, however, it is important to review to ensure proper implementation of the measure. As not all systems and clinical
workflows are the same, it is important to review these changes in the context of a specific system and/or clinical workflow.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62517
D.1. Diabetes: Hemo1dobin Ale (HbAlc) Poor Control (>9%)
Catee:orv
CBE # / eCQM CBE #:
Quality#:
CMSeCQMID:
Current Collection Type:
Current Measure Description:
Substantive Change:
Descriotion
0059 /N/A
001
CMS122vl3
Medicare Part B Claims Measure Specifications/ eCQM Specifications/ MIPS CQM Specifications/
Medicare COM Soecifications (collection tvoe available onlv in the APP and/or APP Plus)
Percentage of patients 18-75 years of age with diabetes who had hemoglobin Ale> 9.0% during the
measurement period.
The measure title is revised from "Diabetes: Hemoglobin Ate (HbAlc) Poor Control (>9%)" to:
Diabetes: Glycemic Status Assessment Greater Than 9%.
The measure description is revised to read: For all collection types: Percentage of patients 18-75
years of age with diabetes who had a glycemic status assessment (hemoglobin A I c [HbA l c] or
glucose management indicator [GM!])> 9.0% during the measurement period.
Updated denominator exclusion: For all collection types: Removed: specific encounter
requirements from the frailty/advanced illness exclusion.
The measure numerator is revised to read: For all collection types: Patients whose most recent
glycemic status assessment (HbA le or GM!) (performed during the measurement period) is> 9.0%
or is missing, or was not performed during the measurement period.
Updated guidance: For the eCQM Specifications collection type: Revised: If the glycemic status
assessment (HbA l c or GMT) is in the medical record, the test can be used to determine numerator
compliance.
Added: Glycemic status assessment (HbAlc or GM!) must be reported as a percentage(%).
If multiple glycemic status assessments were recorded for a single date, use the lowest result.
Updated numerator instructions: For the MIPS CQM Specifications and the Medicare Part B
Claims Measure Specifications collection types: Added: GM! as an assessment option.
Updated numerator options: For the MIPS CQM Specifications and the Medicare Part B
Claims Measure Specifications collection types: Added: GMI as an assessment option.
Measure Steward:
High Priority Measure:
Measure Tvoe:
Rationale
Updated numerator note: For the MlPS CQM Specifications and the Medicare Part B Claims
Measure Specifications collection types: Added: If multiple glycemic status assessments were
recorded for a single date, use the lowest result.
National Committee for Oualitv Assurance
Yes
Intermediate Outcome
We are proposing to revise this measure to include glucose management indicators (GM!) to broaden
the acceptable methods for monitoring the glycemic status of patients with diabetes. This measure
revision supports those clinicians that are using this monitoring method lo ensure management of
persons with diabetes using continuous glucose monitoring_l38
EISayed, N. A., Aleppo, G., Aroda, V. R., Bannuru, R.R., Brown, F. M., Bruemmer, D., Collins, B. S., Hilliard, M. E.,
Isaacs, D., Johnson, E. L., Kahan, S., Khunti, K., Leon, J., Lyons, S. K., Perry, M. L, Prahalad, P., Pratley, R. E., Seley, J.
J., Stanton, R. C., Gabbay, R. A., ... on behalf of the American Diabetes Association (2023). 7. Diabetes Technology:
Standards of Care in Diabetes-2023. Diabetes Care, 46(Suppl 1), S111-S127. https://doi.org/10.2337 /dc23-S007.
138
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We are also proposing to update the denominator exclusion by removing the requirement for patients
to have had at least one inpatient or two outpatient encounters to recognize a diagnosis of advanced
illness. The removal ofthi~ requirement within the denominator exclusion reduces the burden of
identifying applicable encounters, while still identifying patients with an indication of frailty. This is
particularly applicable for those patients seen outside of their reporting clinician's medical record.
This revision would update the denominator exclusion to remove any patient 66 years of age and
older who has a diagnosis of advanced illness during the measurement period or the year prior from
the denominator of measure QO0I. Decreasing complexity and burden of this element ensures
consistent implementation allowing for more comparable data.
62518
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
D.2. Anti-Depressant Medication Management
Category
CBE # I eCQM CBE #:
Quality#:
CMSeCQMID:
Current Collection Tvoe:
Current Measure Description:
Substantive Change:
Description
NIA/NIA
009
CMS128vl3
eCQM Soecifications
Percentage of patients 18 years of age and older who were treated with antidepressant medication,
had a diagnosis of major depression, and who remained on an antidepressant medication treatment.
Two rates are reported.
a. Percentage of patients who remained on an antidepressant medication for at least 84 days (12
weeks).
b. Percentage of patients who remained on an antidepressant medication for at least 180 days (6
months).
The measure initial patient population is revised to read: Patients 18 years of age and older as of
the IPSD who were dispensed antidepressant medications during the Intake Period, and were
diagnosed with major depression 60 days prior to, or 60 days after the dispensing event and had a
visit 60 days prior to, or 60 days after the dispensing event.
Updated logic and logic definition: Revised: logic to base it on age and TPSD.
National Committee for Quality Assurance
No
Process
We are proposing to revise the initial patient population look-back window to evaluate the age of the
patient when medication is dispensed during the intake period. The updated timeframe distinguishes
between a new prescription and a continuing prescription to ensure the measure logic is more
accurate in determining the antidepressant treatment has met the numerator's quality action. We are
also proposing to update the logic to look at the age and IPSD so that the look-back window allows
all oatients to be assessed for the exclusion criteria related to orevious anti-deoression medication.
Measure Steward:
High Prioritv Measure:
Measure Tvne:
Rationale
D.3. Diabetic Retinopathy: Communication with the Physician Managing Ongoing Diabetes Care
Category
CBE # I eCQM CBE #:
Quality#:
CMSeCQMID:
Current Collection Tvoe:
Current Measure Description:
Substantive Change:
Description
NIA/NIA
019
CMS142vl3
eCQM Soecifications / MIPS CQM Specifications
Percentage of patients aged 18 years and older with a diagnosis of diabetic retinopathy who had a
dilated macular or fundus exam performed with documented communication to the physician who
manages the ongoing care of the patient with diabetes mellitus regarding the findings of the macular
or fundus exam at least once during the performance period.
Modified collection type: eCQM Specifications collection type.
Updated Guidance: Revised: The communication ofresults, including the level of severity of
diabetic retinopathy and presence or absence of macular edema to the primary care physician
providing ongoing care of a patient's diabetes should be completed soon after the dilated exam is
performed.
American Academy of Ophthalmology
Yes
Process
We are proposing to remove the MIPS CQM Specifications collection type as it has reached the end
of the topped-out lifecycle (82 FR 53640). The average performance rate and topped-out status is
based on the current MIPS benchmarking data located at https://qpp.cms.gov/benchmarks. However,
the benchmarking data continues to show a gap for the eCQM Specifications collection type and as
such, we are proposing to retain that collection type.
Measure Steward:
Hi!!:h Prioritv Measure:
Measure Tvne:
Rationale
EP31JY24.479
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Additionally, we are proposing to revise the measure guidance to define required information to be
included within the report for the purposes of numerator compliance. This ensures all appropriate
information is being communicated for oatient care coordination.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62519
D.4. Advance Care Plan
Catel!orv
CBE # I eCQM CBE #:
Qualitv#:
CMSeCQMID:
Current Collection TvPe:
Current Measure Description:
Substantive Change:
Measure Steward:
Hil!h Prioritv Measure:
Measure Tvpe:
Rationale
Description
0326 I NIA
047
NIA
Medicare Part B Claims Socifications, MIPS COM Soecifications
Percentage of patients aged 65 years and older who have an advance care plan or surrogate decision
maker documented in the medical record or documentation in the medical record that an advance care
plan was discussed but the patient did not wish or was not able to name a surrogate decision maker or
orovide an advance care olan.
Updated the denominator criteria: For the MIPS CQM Specifications and the Medicare Part B
Specifications collection types: Added: coding for neuropsychologv.
National Committee for Quality Assurance
Yes
Process
We are proposing to update denominator criteria to include coding for neuropsychology as this
measure is applicable to their scope of care.
D.5. Diabetes: Eye Exam
Catel!orv
CBE # I eCQM CBE #:
Qualitv #:
CMSeCQMID:
Current Collection Type:
Current Measure Description:
Substantive Change:
EP31JY24.481
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Measure Steward:
Hi!!h Priority Measure:
Measure Type:
Rationale
Description
0055 /N/A
117
CMSl31vl3
eCQM Specifications/ MIPS CQM Specifications
Percentage of patients 18-75 years of age with diabetes and an active diagnosis of retinopathy in any
part of the measurement period who had a retinal or dilated eye exam by an eye care professional
during the measurement period or diabetics with no diagnosis ofretinopathy in any part of the
measurement period who had a retinal or dilated eye exam by an eye care professional during the
measurement period or in the 12 months prior to the measurement period.
Updated denominator exclusion: For all collection types: Removed: specific encounter
requirements from the frailty/advanced illness exclusion.
National Committee for Quality Assurance
No
Process
We are proposing to update the denominator exclusion by removing the requirement for patients to
have had at least one inpatient or two outpatient encounters to recognize a diagnosis of advanced
illness. The removal of this requirement within the denominator exclusion reduces the burden of
identifying applicable encounters, while still identifying patients with an indication of frailty. This is
particularly applicable for those patients seen outside of their reporting clinician's medical record.
This revision would update the denominator exclusion to remove any patient 66 years of age and
older who has a diagnosis of advanced illness during the measurement period or the year prior from
the denominator of measure Ql 17. Decreasing complexity and burden of this element ensures
consistent implementation allowing for more comparable data.
62520
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
D.6. Documentation of Current Medications in the Medical Record
Catee:ory
CBE # / eCQM CBE #:
Quality#:
CMSeCOMID:
Current Collection Tvne:
Current Measure Description:
Substantive Change:
Description
NIA/NIA
130
CMS68vl4
eCOM Snecifications / MIPS COM Snecifications
Percentage of visits for patients aged 18 years and older for which the eligible clinician attests to
documenting a list of current medications using all immediate resources available on the date of the
encounter.
The measure description is revised to read: For all collection types: Percentage of visits for which
the eligible clinician attests to documenting a list of current medications using all immediate
resources available on the date of the encounter.
Updated guidance: For the eCQM specifications collection type: Revised: allows for
documentation to be completed on the day of the encounter.
Updated initial patient population: For the eCQM specifications collection type: Removed: age
criteria.
Updated denominator: For the MIPS CQM Specifications collection type: Removed: age
criteria.
Updated denominator criteria: For the MIPS CQM Specifications collection type: Removed:
age criteria.
Added: coding for pediatric audiology services.
Measure Steward:
Hil!h Prioritv Measure:
Measure Type:
Rationale
Updated numerator note: For the MIPS CQM Specifications collection type: Revised: allows for
documentation to be completed on the day of the encounter.
Centers for Medicare & Medicaid Services
Yes
Process
We are proposing to update multiple components of the measure to remove the age criteria so that all
patients, regardless of age, are assessed for having a list of their current medications documented in
their medical record. This revision broadens the denominator., supporting assessment of current
medications for all patient age ranges. Assessing for missing information about the dosage, route, or
frequency of a medication supports clinical communication and may assist in avoiding patient
harm. 119
Additionally, we are proposing to update the measure to allow for the quality action to occur on the
day of the encounter rather than limiting to during the encounter. This allows for flexibility to align
with the clinician's workflows and systems.
139 Owen, M. C., Chang, N. M., Chong, D. H., & Vawdrey, D. K. (2011). Evaluation of Medication List Completeness,
Safety, and Annotations. AM/A Annual Symposium Proceedings. AM/A Symposium, 2011, 1055-1061.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3243276/.
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We are also proposing to update the denominator criteria to include coding for pediatric audiology
services as this measure is applicable to their scope of care.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62521
D.7. Oncology: Medical and Radiation - Pain Intensity Quantified
Cate1wrv
CBE # I eCQM CBE #:
Quality#:
CMSeCQMID:
Current Collection Type:
Current Measure
Description:
Substantive Change:
Measure Steward:
Hi2h Prioritv Measure:
Measure Tvpe:
Rationale
Description
0384 / 0384e
143
CMSl57vl3
eCQM Specifications/ MIPS CQM Specifications
Percentage of patient visits, regardless of patient age, with a diagnosis of cancer currently receiving
chemotherapv or radiation therapv in which pain intensitv is auantified.
Updated initial patient population: For the eCQM Specifications collection type: Revised:
Population I: All patient visits, regardless of patient age, with a diagnosis of cancer currently receiving
chemotherapy.
Population 2: All patient visits, regardless of patient age, with a diagnosis of cancer currently receiving
radiation therapy
American Society of Clinical Oncology
Yes
Process
We are proposing to revise this measure to split the initial patient population to delineate between patients
who are receiving radiation therapy and are assessed for pain intensity and their pain level quantified. This
additional patient population would allow clinicians reporting this measure the ability to distinguish their
performance between patients receiving chemotherapy and those receiving radiation services. It would also
align the measure across all collection types.
D.8. Falls: Plan of Care
Cate2orv
CBE # I eCQM CBE #:
Qualitv#:
CMSeCQMID:
Current Collection Type:
Current Measure Description:
EP31JY24.484
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Substantive Chan!!e:
Measure Steward:
Hi2h Priority Measure:
Measure Type:
Rationale
Description
0101 / N/A
155
N/A
Medicare Part B Claims Measure Specifications/ MIPS CQM Specifications
Percentage of patients aged 65 years and older with a history of falls who had a plan of care for falls
documented within 12 months.
Modified collection tvne: MIPS COM Snecifications collection !voe.
National Committee for Quality Assurance
Yes
Process
We are proposing to revise this measure by removing the Medicare Part B Claims Measure
Specifications collection type for this measure as it has reached the end of the topped-out lifecycle
(82 FR 53640). The average performance rate is based on the current 2024 MIPS benchmarking data
located at https://avv.cms.,1:ov/benchmarks.
62522
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
D.9. Coronary Artery Bypass Graft (CABG): Surgical Re-Exploration
Cate2ory
Description
CBE # / eCOM CBE #:
0115 !NIA
Quality#:
168
CMSeCOMID:
NIA
Current Collection Tvne:
MIPS COM Soecifications
Current Measure Description:
Percentage of patients aged 18 years and older undergoing isolated CABG surgery who require a
return to the operating room (OR) during the current hospitaliwtion for mediastinal bleeding with or
without tamnonade. !!raft occlusion, valve dvsfunction or other cardiac reason.
The measure description is revised to read: Percentage of patients aged 18 years and older
undergoing isolated CABG surgery who require a return to the operating room (OR) for mediastinal
bleeding with or without tamponade, unplanned coronary artery intervention (native vessel, graft or
both), valve dysfunction, aortic reintervention or other cardiac reason during the current
hospitaliwtion.
Substantive Change:
The measure numerator is revised to read: Patients undergoing isolated CABG surgery who
require a return to the OR for mediastinal bleeding with or without tamponade, unplanned coronary
artery intervention (native vessel, graft or both), valve dysfunction, aortic reintervention or other
cardiac reason during the current hospitalization.
140 Tran, Z., Williamson, C., Hadaya, J., Verma, A., Sanaiha, Y., Chervu, N., Gandjian, M., & Benharash, P. (2022).
Trends and Outcomes of Surgical Reexploration After Cardiac Operations in the United States. The Annals of
Thoracic Surgery, 113(3), 783-792. https://doi.org/10.1016/j.athoracsur.2021.04.011.
141 See footnote Tran et al., 2022.
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Measure Steward:
Hi!i:h Prioritv Measure:
Measure Type:
Rationale
Updated numerator options: Added: unplanned coronary artery intervention (native vessel, graft,
or both) and aortic reintervention
Society of Thoracic Surgeons
Yes
Outcome
We are proposing to revise this measure to broaden the scope of cardiac complications that may
require a return to the operating room following isolated CABG surgery. These revisions support the
measure to decrease surgical re-exploration following CABG surgery, which is a serious complication
and impacts length of stay, efficient use of resources, and increases risk for additional injury and
death. 140 Although rates ofre-exploration after cardiac surgery have significantly declined recently, it
has been linked to much hi2her comolications. mortalitv. and hosoitalizations. 141
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62523
D.10. Tuberculosis Screening Prior to First Course of Biologic and/or Immune Response Modifier Therapy
Description
Catee:ory
CBE # / eCQM CBE #:
Quality#:
CMSeCOMID:
Current Collection Tvne:
Current Measure Description:
MIPS COM Snecifications
If a patient has been newly prescribed a biologic and/or immune response modifier that includes a
warning for potential reactivation of a latent infection, then the medical record should indicate TB
testing in the orecedine 12-month oeriod.
Undated denominator instructions: Added: new biosimilar medications.
American College ofRheurnatologv
No
Process
We are proposing to update the list of medications by adding new biosimilar medications to the
existing list in the denominator instructions. This expansion would provide an up-to-date list of
appropriate biologics and/or immune response modifiers that clinicians may have prescribed for their
patients, thereby ensuring that the right patients are identified in the denominator of this measure.
These targeted immunotherapies are associated with a high risk of progression to active TB infection,
therefore screening for latent TB prior to initiating first course therapy is highly recommended since
it has been shown to effectively reduce the incidence of progression in patients with latent TB. 142
CDC. (2020). Latent Tuberculosis Infection -A Guide for Primary Health Care Providers.
https://www.cdc.gov/tb/ media/pdfs/Latent-TB-lnfection-A-G uide-for-Primary-Health-Ca re-Providers.pd(
142
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Substantive Chaoe:e:
Measure Steward:
ffigh Prioritv Measure:
Measure Tvne:
Rationale
NIA/NIA
176
NIA
62524
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
D.11. Rheumatoid Arthritis (RA): Periodic Assessment of Disease Activity
Cate2ory
Description
CBE # / eCQM CBE #:
2523 /N/A
Quality#:
177
CMSeCOMID:
NIA
Current Collection Tvne:
Ml PS COM Snecifications
Current Measure Description:
Percentage of patients aged 18 years and older with a diagnosis of rheumatoid arthritis (RA) who
have an assessment of disease activity using an A CR-preferred RA disease activity assessment tool at
>50% of encollllters for RA for each oatient durin!! the measurement vear.
Substantive Change:
The measure description is revised to read: Percentage of patients aged 18 years and older with
two or more diagnoses of rheumatoid arthritis (RA) at least 90 days apart who have an assessment of
disease activity using an ACR-preferred RA disease activity assessment tool at ,::50% of encounters
for RA for each patient during the performance period.
The measure denominator is revised to read: Patients aged 18 years and older with two or more
RA diagnoses documented at least 90 days apart with at least one encounter with an RA diagnosis
occurring during the performance period and an additional encounter with an RA diagnosis occurring
in the performance period or prior performance period.
Updated denominator definition: Added:
Encounter -An encounter during the performance period where one of the CPT or HCPCS codes
listed in the patient encounter criteria is used without a telehealth modifier (i.e., only non-telehealth
visits are to be considered for this measure).
Additional encounter -An additional encounter during the performance period or prior performance
period where one of the CPT or HCPCS codes listed in the patient encollllter is used to confirm an
RA diagnosis with ICD-10-CM diagnosis codes as listed in the Denominator criteria.
Updated denominator criteria: Added: An additional encounter with an RA diagnosis during the
performance period or prior performance period that is at least 90 days before or after an encounter
with an RA diagnosis during the performance period.
Measure Steward:
Hi!!h Prioritv Measure:
Measure TYJJe:
Rationale
Updated numerator definition: Revised: A result within the valid range of the selected tool
qualifies for meeting numerator performance as long as a result is captured at 2:50% of each patient's
qualified encounters. If the result ofa recorded disease activity assessment is outside the valid range
of scores for the tool (e.g., a CDAI score of 101 when the maximum possible score is 76.0) or is only
recorded as a disease activity level (e.g., low, moderate, or high) in place ofa calculated numerical
score this score should not be included in the count to meet the >50% requirement in the numerator.
American College of Rheumatologv
No
Process
We are proposing to revise the denominator to provide greater specificity on the timeframc and
criteria for denominator coding and how it should be captured to ensure the appropriate patients are
being identified for this measure. Diagnosing RA requires "a combination of physical exams., blood
tests for inflammatory markers, and imaging tests (like X-rays and MRis), in addition to patientreported symptoms," which can take multiple visits to determine an accurate assessment of RA
disease activity. 143 Therefore, this change would align more closely with the worktlow of clinicians
and allows the assessment of a patient for RA disease activity during more than one clinical visit.
These changes support a comprehensive perspective of the patient's disease activity level and should
promote optimal treatment outcomes.
Brody, B. (2020). The American College of Rheumatology Updated Its Approved Disease Activity Measures for
Rheumatoid Arthritis - Here's What That Means. https://creakyjoints.org/living-witharthritis/symptoms/approved-disease-activity-measures-for-rheumatoid-arthritis/.
143
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We are proposing to revise the definition for 'Assessment of Disease Activity' to confirm that only
those assessments where the disease activity is correctly recorded are included in the numerator
quality action for the purposes of meeting performance. Not only do the results need to be within the
range of the selected validated qualifying tool, but also a calculated numeric score and not simply a
disea~e activity level. This ensures that all assessment information is correctly captured to drive
appropriate care.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62525
D.12. Rheumatoid Arthritis (RA): Functional Status Assessment
Catee:ory
CBE # / eCQM CBE #:
Quality#:
CMSeCOMID:
Current Collection Tvne:
Current Measure Description:
Substantive Change:
Description
NIA/NIA
178
NIA
Ml PS COM Snecifications
Percentage of patients aged 18 years and older with a diagnosis ofrheumatoid arthritis (RA) for
whom a functional status assessment was performed at least once within 12 months.
The measure description is revised to read: Percentage of patients aged 18 years and older with
two or more diagnoses of rheumatoid arthritis (RA) at least 90 days apart for whom a functional
status assessment was performed at least once during the performance period.
The measure denominator is revised to read: Patients aged 18 years and older with two or more
RA diagnoses documented at least 90 days apart with at least one encounter with an RA diagnosis
occurring during the performance period and an additional encounter with an RA diagnosis occurring
in the performance period or prior performance period.
Updated denominator definition: Added:
Encounter - An encounter during the performance period where one of the CPT or HCPCS codes
listed in the patient encounter criteria is used.
Additional encounter - An additional encounter during the performance period or prior performance
period where one of the CPT or HCPCS codes listed in the patient encounter is used to confirm an
RA diagnosis with ICD-10-CM diagnosis codes as listed in the Denominator criteria.
144
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Measure Steward:
Hhzh Prioritv Measure:
Measure Type:
Rationale
Updated denominator criteria: Added: an additional encounter with an RA diagnosis during the
performance period or prior performance period that is at least 90 days before or after an encounter
with an RA diagnosis during the performance period.
American College of Rheumatologv
No
Process
We are proposing to revise the denominator to provide greater specificity on the timeframe and
criteria for denominator coding and how it should be captured to ensure the appropriate patients are
being identified for this measure. Diagnosing RA requires "a combination of physical exams, blood
tests for inflammatory markers, and imaging tests (like X-rays and MRls), in addition to patientreported symptoms," which can take multiple visits to determine an accurate assessment of RA
disease activity. 144 Therefore, this change would align more closely with the worktlow of clinicians
and allows assessment of a patient for RA disease activity during more than one clinical visit. These
changes support a comprehensive perspective of the patient's disease activity level and should
oromote ootimal treatment outcomes.
62526
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
D.13. Rheumatoid Arthritis (RA): Glucocorticoid Management
Cate2ory
CBE # / eCQM CBE #:
Quality#:
CMSeCOMID:
Current Collection Tv11e:
Current Measure Description:
Substantive Change:
Description
NIA/NIA
180
NIA
MIPS COM Snecilications
Percentage of patients aged 18 years and older with a diagnosis of rheumatoid arthritis (RA) who
have been assessed for glucocorticoid use and, for those on prolonged doses ofprednisone > 5 mg
daily (or equivalent) with improvement or no change in disease activity, documentation of
gJucocorticoid management olan within 12 months.
The measure description is revised to read: Percentage of patients aged 18 years and older with
two or more diagnoses of rheumatoid arthritis (RA) at least 90 days apart who have been assessed for
glucocorticoid use and, for those on prolonged doses of prednisone >5 mg daily (or equivalent) with
improvement or no change in disease activity, documentation ofglucocorticoid management plan
during the performance period.
The measure denominator is revised to read: Patients aged 18 years and older with two or more
RA diagnoses documented at least 90 days apart with at least one encounter with an RA diagnosis
occurring during the performance period and an additional encounter with an RA diagnosis occurring
in the performance period or prior performance period.
Updated denominator definition: Added:
Encounter -An encounter during the performance period where one of the CPT or HCPCS codes
listed in the patient encounter criteria is used.
Additional encounter -An additional encounter during the performance period or prior performance
period where one of the CPT or HCPCS codes listed in the patient encounter is used to confirm an
RA diagnosis with ICD-10-CM diagnosis codes as listed in the Denominator criteria.
145
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Measure Steward:
Hi2h Prioritv Measure:
Measure Tvoe:
Rationale
ll pdated denominator criteria: Added: An additional encounter with an RA diagnosis during the
performance period or prior performance period that is at least 90 days before or after an encounter
with an RA diagnosis during the oerformance neriod.
American Collel!;e ofRheumatoloJl;Y
No
Process
We are proposing to revise the denominator to provide greater specificity on the timeframe and
criteria for denominator coding and how it should be captured to ensure the appropriate patients are
being identified for this measure. Diagnosing RA requires "a combination of physical exams, blood
tests for inflammatory markers, and imaging tests (like X-rays and MR!s), in addition to patientreported symptoms," which can take multiple visits to determine an accurate assessment of RA
disease activity. 145 Therefore, this change would align more closely with the worktlow of clinicians
and allows assessment of a patient for RA disease activity during more than one clinical visit. These
changes support a comprehensive perspective of the patient's disease activity level and should
promote optimal treatment outcomes.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
Catee:ory
CBE # I eCQM CBE #:
Quality#:
CMSeCOMID:
Current Collection Tvne:
Current Measure Description:
146
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D.14. Elder Maltreatment Screen and Follow-Up Plan
Description
NIA/NIA
181
NIA
Medicare Part B Claims Measure Snecifications I MIPS COM Soecifications
Percentage of patients aged 60 years and older with a documented elder maltreatment screen using an
Elder Maltreatment Screening tool on the date of encounter AND a documented follow-up plan on
the date of the oositive screen.
Undated denominator criteria: For all collection tvoes: Added: coding for emergency department.
Centers for Medicare & Medicaid Services
Yes
Process
We are proposing to add encounter codes for emergency department (ED) visits to the denominator
criteria as the emergency department is an appropriate setting for screening for elder maltreatment.
"EDs arc a potentially important setting for elder mistreatment identification hecausc they provide
care for a large number of older adults who may be elder mistreatment victims" especially given that
the ED is sometimes the only clinical setting that the patient may visit. 146 Expanding the denominator
to include ED visits ensures a more complete denominator patient population and provides support
and delivery of interventions that could prevent actual abuse.
See footnote Rosen et al., 2020 in Table 8.11 of this Appendix.
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Substantive Chane:e:
Measure Steward:
Hi!!h Prioritv Measure:
Measure Tvne:
Rationale
62527
62528
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
Catee:ory
CBE # / eCQM CBE #:
Quality#:
CMSeCOMID:
Current Collection Tvue:
Current Measure Description:
Substantive Change:
NIA/NIA
182
NIA
MIPS COM Snecifications
Percentage of visits for patients aged 18 years and older with documentation of a current functional
outcome assessment using a standardized functional outcome assessment tool on the date of the
encounter AND documentation of a care plan based on identified functional outcome deficiencies
within two davs of the date of the identified deficiencies.
Updated numerator definition: Revised:
Measure Steward:
Hie:h Priority Measure:
Measure Tv11e:
Rationale
Functional Outcome Assessment: Patient completed questionnaires designed to measure a patient's
limitations in performing the usual human tasks ofliving and to directly quantify functional and
behavioral symptoms. lf a patient is unable to complete a questionnaire, a standardized clinical
assessment tool may be used to measure a patient's limitations.
Added: To Table 1. Definitions for Magnitude ofEflects, Based on Mean Between-Group
Differences - Modified*: clarification that list of standardized tools is not exhaustive.
Centers for Medicare & Medicaid Services
Yes
Process
We are proposing to update the numerator definition to clarify that clinicians may use a standardized
clinical assessment tool to measure a patient's limitation if they are unable to complete a
questionnaire. This change would allow flexibility in performing the quality action and clarify that
the list of standardized tools named in the measure are only examples, not an exhaustive list. The
National Institute of Health indicates that it supports the use of standardized tools, stating they offer a
clinician-designed approach to promoting care standardization that accommodates patients' individual
differences, respects clinicians' clinical judgement, and keeps pace with the rapid growth of medical
knowledge. 147
147 Farias, M., Jenkins, K., Lock, J., Rathod, R., Newburger, J., Bates, D. W., Safran, D. G., Friedman, K., & Greenberg,
J. (2013). Standardized Clinical Assessment and Management Plans (SCAMPs) Provide a Better Alternative to
Clinical Practice Guidelines. Health Affairs (Project Hope), 32(5), 911-920.
https://doi.org/10.1377/hlthaff.2012.0667.
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D.15. Functional Outcome Assessment
Description
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62529
D.16. Colonoscopy Interval for Patients with a History of Adenomatous Polyps -Avoidance oflnappropriate Use
Category
CBE # I eCQM CBE #:
Quality#:
CMSeCQMID:
Current Collection Tvoe:
Current Measure Description:
Substantive Change:
Measure Steward:
High Prioritv Measure:
Measure Type:
Rationale
Description
NIA/NIA
185
NIA
MIPS CQM Soecifications
Percentage of patients aged 18 years and older receiving a surveillance colonoscopy, with a history of
prior adenomatous polyp(s) in previous colonoscopy findings, which had an interval of3 or more
years since their last colonoscopy.
Updated denominator exception: Added: To the 'Documentation of system reasons(s): patient
cannot provide precise date or details from previous colonoscopv,
American Gastroenterological Association
Yes
Process
We are proposing to update the denominator exception to exclude patients that are unable to provide
the precise date or details from a previous colonoscopy. This addition would assist with data
collection when a patient with a history of adenomatous polyps is unable to provide information
regarding their last colonoscoPv.
D.17. Controlling High Blood Pressure
Category
CBE # I eCQM CBE #:
Quality#:
CMSeCQMID:
Current Collection Type:
Current Measure Description:
Substantive Change:
EP31JY24.493
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Measure Steward:
Hi!!h Prioritv Measure:
Measure Tvne:
Rationale
Description
NIA/NIA
236
CMSl65vl3
Medicare Part B Claims Measure Specifications/ eCQM Specifications/ MIPS CQM Specifications/
Medicare CQM Specifications (collection type available only in the APP and/or APP Plus)
Percentage of patients 18-85 years of age who had a diagnosis of essential hypertension starting
before and continuing into, or starting during the first six months of the measurement period, and
whose most recent blood pressure was adequately controlled (<140/90mmHg) during the
measurement Period.
Updated denominator exclusion: For all collection types: Removed: specific encounter
requirements from the frailtv/advanced illness exclusion.
National Committtee for Qualitv Assurance
Yes
Intermediate Outcome
We are proposing to update the denominator exclusion by removing the requirement for patients to
have had at least one inpatient or two outpatient encounters to recognize a diagnosis of advanced
illness. The removal of this requirement within the denominator exclusion reduces the burden of
identifying applicable encounters, while still identifying patients with an indication of frailty. This is
particularly applicable for those patients seen outside of their reporting clinician's medical record.
This revision would update the denominator exclusion to remove any patient 66 years of age and
older who has a diagnosis of advanced illness during the measurement period or the year prior from
the denominator of measure Q236. Decreasing complexity and burden of this element ensures
consistent implementation allowing for more comparable data.
62530
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
D.18. Use of High-Risk Medications in Older Adults
Catel!ory
CBE # / eCQM CBE #:
Oualitv#:
CMSeCQMID:
Current Collection Tvne:
Current Measure Description:
Substantive Change:
Description
0022/N/A
238
CMS156vl3
eCOM Soecifications / MIPS COM Soecifications
Percentage of patients 65 years of age and older who were ordered at least two high-risk medications
from the same dru!! class.
Updated numerator definition: For the MIPS CQM Specifications collection type:
Numerator (Submission Criteria I): Table I - High-Risk Medications at any Dose or Duration
Removed:
From Anticholinergics, first-generation antihistamines: Carbinoxamine, Clemastine,
Dexbrompheniramine, Dexchlorpheniramine, Pyrilamine
From Antispasmodics: Belladonna alkaloids, Metbscopolamine, Propantheline
From Cardiovascular, alpha agonists, central: Methyldopa
From Cardiovascular, other: Disopyramide
From Central nervous system, antidepressants: Protriptyl ine Trimipramine
From Central nervous system, barbiturates: Amobarbital, Butabarbital, Pentobarbital, Secobarbital
From Central nervous system, vasodilators: lsoxsuprine
From Endocrine system, sulfonylureas, long-duration: Chlorpropamide
From Endocrine system, other: Mcgestrol
From Pain medications, other: Meperidine
Added: A row with one medication is considered a group (or drug class) ofone; therefore, two orders
of that same medication are numerator compliant.
Added:
To Central nervous system, barbiturates: Primidone
Endocrine system, megestrol: Megestrol
Pain medications, meperidine: Meperidine
To Pain medications, other: Ketorolac, includes parenteral and oral
Table 3 - High-Risk Medications With Average Daily Dose Criteria
Removed:
Alpha agonists, central: Reserpine >0.1 mg per day
Numerator (Submission Criteria 2): Table 4- High-Risk Medications
Removed:
From Benzodiazepines, long, short and intermediate acting: Flurazepam, Quazepam
Added:
The 2023 American Geriatrics Society Beers Criteria Update Expert Panel. (2023). American Geriatrics Society
2023 updated AGS Beers Criteria for potentially inappropriate medication use in older adults. Journal of the
American Geriatrics Society, 71(7), 2052-2081. https://doi.org/10.1111/jgs.18372.
148
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Measure Steward:
Hi!!h Prioritv Measure:
Measure Type:
Rationale
To Benzodiazepines long, short and intermediate acting: Clobazam
National Committee for Qualitv Assurance
Yes
Process
We are proposing to update the list of high-risk medications to align with 2023 AGS Beers Criteria 148
and ensure that older adults are not prescribed inappropriate medications. This change would also
align with PY 2025 eCQM version (CMS I56vl 3), which supports alignment between the collection
types. We are also proposing to add clarification that the medications found within a single row of
table one, within the specification, represent a unique group or drug class. Therefore, two orders from
that group or drug class would be consider numerator compliant for this measure, which has an
inverse analvtic for the calculation ofoerformance.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62531
D.19. Barrett's Esophagus
Cateeorv
CBE # I eCQM CBE #:
Qualitv #:
CMSeCQMID:
Current Collection Tvpe:
Current Measure Description:
Substantive Change:
Description
NIA/NIA
249
NIA
Medicare Part B Claims Measure Specifications/ MIPS CQM Specifications
Percentage of esophageal biopsy reports that document the presence of Barrett's mucosa that also
include a statement about dvsplasia.
Updated denominator exception: For all collection types: Added: Specimen site other than
anatomic location of esophagus.
Updated denominator exclusion: For all collection types: Removed: Specimen site other than
anatomic location of esophagus.
College of American Pathologists
No
Process
We are proposing to remove the denominator exclusion so that all patients with a diagnosis for
Barrett's Esophagus are included in the denominator of the measure and are proposing to add a
denominator exception for specimen sites other than the anatomic location of the esophagus.
Revising the measure to include this element as a denominator exception would allow for an
automated capture of the relevant cases with less manual intervention reducing overall burden of
measure reporting.
Measure Steward:
Hieb Prioritv Measure:
Measure Tvpe:
Rationale
D.20. Sleep Apnea: Severity Assessment at Initial Diagnosis
Cateeorv
CBE # I eCQM CBE #:
Qualitv #:
CMSeCQMID:
Current Collection Tvpe:
Current Measure Description:
Substantive Change:
EP31JY24.496
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Measure Steward:
Hieb Prioritv Measure:
Measure Tvpe:
Rationale
Description
NIA/NIA
277
NIA
MIPS CQM Specifications
Percentage of patients aged 18 years and older with a diagnosis ofobstructive sleep apnea who had
an apnea hypopnea index (AHI), a respiratory disturbance index (RDT), or a respiratory event index
(REI) documented or measured within 2 months of initial evaluation for suspected obstructive sleep
apnea.
Updated denominator exception: Added: patients previously diagnosed with OSA and severity
assessed by another provider.
American Academy of Sleep Medicine
No
Process
We are proposing to update the denominator exception by adding that patients previously diagnosed
with obstructive sleep apnea (OSA), with severity assessed by another clinician and documented
would not need to have the testing completed again. This denominator exceptions allows clinician
judgement as to whether repeat testing is needed, as we don't want to promote overutilization. This
revision increases clarity of this element and ensures consistent implementation allowing for more
comparable data.
62532
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
D.21. Dementia: Cognitive Assessment
Cate2ory
CBE # / eCQM CBE #:
Quality#:
CMSeCOMID:
Current Collection Tvne:
Current Measure Description:
Substantive Change:
Office of the Assistance Secretary for Planning and Evaluation. (2016). Examining Models of Dementia Care:
Fina I Report. https://aspe.hhs.gov/reports/exam i ni ng-models-dementia-care-final-report-0.
149
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Measure Steward:
High Prioritv Measure:
Measure Tvne:
Rationale
Description
N/A/2872e
281
CMSl49vl3
eCOM Snecifications
Percentage of patients, regardless of age, with a diagnosis of dementia for whom an assessment of
cognition is performed and the results reviewed at least once within a 12-month period.
Updated guidance: Added: The measure requires a diagnosis of dementia is present before the
routine assessment of cognition once in a 12-month period.
American Academv of Neurology
No
Process
We are proposing to update the measure guidance to clarify that the diagnosis of dementia must be
present prior to the cognitive assessment. This would ensure that any cognitive assessments
perfonned prior to the dementia diagnosis but occurred during the 12-month lookback period would
not be attributed to this measure numerntor. 149 This change would ensure consistency in the
abstrnction of the measure's numerntor elements based upon a specific timeframe that support
rigorous data for the calculation of MIPS performance rates.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62533
D.22. Dementia: Functional Status Assessment
Catee:orv
CBE # / eCQM CBE #:
Quality#:
CMSeCQMID:
Current Collection Type:
Current Measure Description:
Substantive Change:
American Speech-Language-Hearing Association (ASHA). Dementia.
https://www.asha.org/public/speech/disorders/dementia/.
150
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Measure Steward:
Hie:h Priority Measure:
Measure Tvoe:
Rationale
Description
NIA/NIA
282
NIA
Ml PS CQM Specifications
Percentage of patients with dementia for whom an assessment of functional status was performed at
least once in the last 12 months.
Updated denominator criteria: Added: coding for speech language pathology and nuclear
medicine.
American Academv ofNeurolo2v/American Psvchiatric Association
No
Process
We are proposing to add encounter codes for speech language pathologists and nuclear medicine to
the denominator criteria as these are appropriate specialties to identify changes in functional status in
patients diagnosed with dementia. Dementia, which can be caused by "different brain diseases,"
affects a person's activities of daily living including, but not limited to eating and swallowing, and
soeech. 150
62534
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
D.23. Dementia:
C11te2orv
CBE # / eCQM CBE #:
Qualitv#:
CMSeCQMID:
Current Collection Type:
Current Measure Description:
Substantive Change:
151
VerDate Sep<11>2014
NIA /NIA
286
NIA
MIPS CQM Specifications
Percentage of patients with dementia or their caregiver(s) for whom there was a documented safety
concerns screening in two domains of risk: I) dangerousness to self or others and 2) environmental
risks; and if safety concerns screening was positive in the last 12 months, there was documentation of
mitigation recommendations including but not limited to referral to other resources.
Updated denominator criteria: Added: coding for speech language pathology and nuclear
medicine.
American Academv ofNeuroloe:v/American Psvchiatric Association
Yes
Process
We are proposing to update the denominator criteria to include coding for speech language pathology
and nuclear medicine as this measure is applicable to their scope of care. Dementia, which can be
caused by "different brain diseases," affects a person's activities of daily living including, but not
limited to eating and swallowing, and soeech. 151
See footnote ASHA in Table D.22 of this Appendix.
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Measure Steward:
Hie:h Priority Measure:
Measure Tvne:
Rationale
Safety Concern Screening and Follow-Up for Patients with Dementia
Description
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62535
D.24. Dementia: Education and Support of Caregivers for Patients with Dementia
Catee:orv
CBE # / eCQM CBE #:
Quality#:
CMSeCQMID:
Current Collection Type:
Current Measure Description:
Substantive Change:
152
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Measure Steward:
Hie:h Priority Measure:
Measure Tvue:
Rationale
Description
NIA /NIA
288
NIA
MIPS CQM Specifications
Percentage of patients with dementia whose caregiver(s) were provided with education on dementia
disease management and health behavior changes AND were referred to additional resources for
support in the last 12 months.
llpdated denominator criteria: Added: coding for speech language pathology and nuclear
medicine.
American Academv of Neurology/American Psvchiatric Association
Yes
Process
We are proposing to update the denominator criteria to include coding for speech language pathology
and nuclear medicine as this measure is applicable to their scope of care. Dementia, which can be
caused by "different brain diseases," affects a person's activities of daily living including, but not
limited to eating and swallowing, and soeech. 152
62536
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
D.25. Assessment
Cate1rnrv
CBE # I eCQM CBE #:
Quality#:
CMSeCQMID:
Current Collection Tyoe:
Current Measure Description:
Substantive Change:
Measure Steward:
High Priority Measure:
Measure Tyoe:
Rationale
of Mood Disorders and Psvchosis for Patients with Parkinson's Disease
Descriotion
NIA/NIA
290
NIA
MIPS CQM Soecifications
Percentage of all patients with a diagnosis of Parkinson's Disease [PD] who were assessed for
deoression, anxietv, aoathv. AND osvchosis once during the measurement oeriod.
Updated denominator criteria: Added: coding for neuropsychology and behavioral health.
American Academy ofNeurology
No
Process
We are proposing to update the denominator criteria to include coding for neuropsychology and
behavioral health as it's clinically appropriate for these clinician types to assess for depression,
anxietv, aoathv, and osvchosis.
D.26. Assessment of Cognitive Impairment or Dysfunction for Patients with Parkinson's Disease
Category
Descriotion
CBE # I eCQM CBE #:
NIA/NIA
Qualitv#:
291
CMSeCQMID:
NIA
Current Collection Tvoe:
MIPS COM Soecifications
Percentage of all patients with a diagnosis of Parkinson's Disease [PD] who were assessed for
Current Measure Description:
cognitive imoairment or dvsfunction once during the measurement oeriod.
Substantive Change:
Updated denominator criteria: Added: coding for neuropsychology, behavioral health, and
ohvsical and occupational therapy,
Measure Steward:
American Academy ofNeurology
High Priority Measure:
No
Measure Tvoe:
Process
Rationale
We are proposing to update the denominator criteria to include coding for neuropsychology,
behavioral health, and physical and occupational therapy as it's clinically appropriate for these
clinician tvoes to assess for cognitive imoairment or dvsfunction.
EP31JY24.503
EP31JY24.502
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D.27. Rehabilitative Theraov Referral for Patients with Parkinson's Disease
Categorv
Descriotion
NIA/NIA
CBE # I eCQM CBE #:
Quality#:
293
CMSeCQMID:
NIA
MIPS CQM Specifications
Current Collection Type:
Current Measure Description:
Percentage of all patients with a diagnosis of Parkinson's Disease who were referred to physical,
occuoational soeech or recreational theraov once during the measurement oeriod.
Substantive Change:
Updated denominator criteria: Added: coding for neuropsychology, behavioral health, and speech
language oathologv.
American Academv ofNeurologv
Measure Steward:
Hi!!h Prioritv Measure:
Yes
Measure Tvoe:
Process
Rationale
We are proposing to update the denominator criteria to include coding for neuropsychology,
behavioral health, and soeech language oathology as this measure is aoolicable to their scone of care.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62537
D.28. Preventive Care and Screening: Screening for High Blood Pressure and Follow-Up Documented
Catee:ory
CBE # / eCOM CBE #:
Quality#:
CMSeCOMID:
Cnrrent Collection Tvne:
Current Measure Description:
Substantive Change:
Measure Steward:
Hie:h Prioritv Measure:
Measure Tvne:
Rationale
Description
NIA/NIA
317
CMS22v13
Medicare Part B Claims Measure Snecifications / eCOM Soecifications / MIPS COM Soecifications
Percentage of patient visits for patients aged 18 years and older seen during the measurement period
who were screened for high blood pressure AND a recommended follow-up plan is documented, as
indicated if blood oressure is elevated or hvoertensive.
lJpdated denominator criteria: For the MIPS CQM Specifications and the Medicare Part B
Claims Measure Specifications collection types: Added: coding for nutrition/dietitian clinician
type,
Updated numerator definition: For all collection types: Revised: intervals for rescreening for first
and second hvnertensive BP readings_
Centers for Medicare & Medicaid Services
No
Process
We are proposing to add encounter codes for nutrition therapy to the denominator criteria for the
MIPS CQM Specifications and the Medicare Part B Claims Measure Specifications collection types
as this is an appropriate setting to identify people who may have elevated blood pressure (BP)
readings. Nutritional approaches play a pivotal role in helping to reduce the risk of hypertension or
control blood pressure in people with hypertension. 153
153 Physicians Committee for Responsible Medicine. (2023). Nutrition Guide for Clinicians: Hypertension.
https://nutritionguide .perm .org/nutritiongu ide/view/Nutrition_Guide_for_Clin icians/1342053/all/Hypertension.
154 Whelton, P. K., Carey, R. M., Aronow, W. S., Casey, D. E., Jr, Collins, K. J., Dennison Himmelfarb, C., DePalma, S.
M., Gidding, S., Jamerson, K. A., Jones, D. W., Maclaughlin, E. J., Muntner, P., Ovbiagele, B., Smith, S. C., Jr,
Spencer, C. C., Stafford, R. S., Taler, S. J., Thomas, R. J., Williams, K. A., Sr, Williamson, J. D., ... Wright, J. T., Jr
(2018). 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention,
Detection, Evaluation, and Management of High Blood Pressure in Adults: A Report of the American College of
Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Journal of the American College
of Cardiology, 71(19), e127-e248. https://doi.org/10.1016/j.jacc.2017.11.006.
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We are proposing to remove the minimum timeframe for follow-up screenings for patients with
elevated BP readings for all collection types. This change allows clinician discretion to recommend a
follow-up plan based on the patient's current health status. Additionally, this supports stability of this
measure component, as the frequency is each visit, within the specification over time, while still
maintaining consistency with the current guidelines. 154
62538
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
D 29 Aooropriate Follow-Up Interval for Normal Colonoscopy in Avera2e Risk Patients
Catee:orv
CBE # / eCQM CBE #:
Quality#:
CMSeCQMID:
Current Collection Tvne:
Current Measure Description:
Substantive Change:
Description
0658/N/A
320
NIA
Medicare Part B Claims Measure Specifications/ MIPS CQM Specifications
Percentage of patients aged 45 to 75 years of age receiving a screening colonoscopy without biopsy
or polypectomy who had a recommended follow-up interval of at least l O years for repeat
colonoscopy documented in their colonoscopy report.
The measure description is revised to read: For all collection types: Percentage of patients aged
45 to 75 years of age receiving a screening colonoscopy without biopsy or polypectomy who had a
recommended follow-up interval of 10 years for repeat colonoscopy documented in their
colonoscopy report.
Updated numerator: For all collection types: Revised: Patients who had recommended follow-up
interval of IO years for repeat colonoscopy documented in their colonoscopy report.
Updated numerator note: For all collection types: Added: To meet the numerator, patients with a
negative screening colonoscopy should have documentation that they received counseling or
instruction to have a follow-up or repeat colonoscopy in 10 years. A 6 month period before or after
10 years is considered within the recommended follow-up interval.
155 Gupta, S., Lieberman, D., Anderson, J. C., Burke, C. A., Dominitz, J. A., Kaltenbach, T., Robertson, D. J., Shaukat,
A., Syngal, S., & Rex, D. K. (2020). Recommendations for Follow-Up After Colonoscopy and Polypectomy: A
Consensus Update by the US Multi-Society Task Force on Colorectal Cancer. Gastrointestinal Endoscopy, 91(3),
463-485.eS. https://doi.org/10.1016/j.gie.2020.01.014.
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Measure Steward:
Hi2h Prioritv Measure:
Measure Type:
Rationale
Updated numerator options: l<'or all collection types: Revised:
Performance Met: Recommended follow-up interval for repeat colonoscopy of 10 years
documented in colonoscopy report and communicated with patient.
Denominator Exception: Documentation of medical reason(s) for not recommending a 10 year
follow-up interval (e.g., inadequate prep, familial or personal history of colonic polyps, patient had
no adenoma and age is ?: 66 years old, or life expectancy < 10 years, other medical reasons)
Performance Not Met: A 10 year follow-up interval for colonoscopy not recommended, reason not
otherwise specified.
American Gastroenterological Association
Yes
Process
We are proposing to update the measure description, numerator, and numerator options to ensure the
time frame for recommended follow up after a normal colonoscopy for the average risk patient
accurately reflects current guidelines which states "[n]ew observational and modeling studies of
colonoscopy confirm and strengthen the evidence base to support the conclusion that individuals with
normal colonoscopy are at lower-than-average risk for CRC. Based on this reduced risk, we
recommend CRC screening in average-risk individuals be repeated 10 years after a normal
examination complete to the cecum with bowel preparation adequate to detect polyps >5 mm in
size." 155 Additionally, we are proposing to add a numerator note to indicate inclusion of
documentation that the patient has received counseling and instruction on when a repeat colonoscopy
should he scheduled. This change would ensure the patient is aware of clinical recommendations to
drive healthv outcomes.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62539
D.30. Cardiac Stress Imaging Not Meeting Appropriate Use Criteria: Preoperative Evaluation in Low-Risk Surgery
Patients
Catee;ory
CBE # I eCQM CBE #:
Qnalitv #:
CMSeCQMID:
Current Collection Tvoe:
Current Measure Description:
Substantive Change:
Description
NIA/NIA
322
NIA
MIPS COM Soecifications
Percentage of stress single-photon emission computed tomography (SPECT) myocardial perfusion
imaging (MPI), stress echocardiogram (ECHO), cardiac computed tomography angiography (CCTA),
or cardiac magnetic resonance (CMR) perfom1ed in low-risk surgery patients 18 years or older for
oreooerative evaluation during the 12-month submission oeriod.
The measure description is revised to read: Percentage of stress single-photon emission computed
tomography (SPECT) myocardial perfusion imaging (MP[), stress echocardiogram (ECHO),
multigated acquisition scan (MUGA), cardiac computed tomography angiography (CCTA), or cardiac
magnetic resonance (CMR) performed in low-risk surgery patients 18 years or older for preoperative
evaluation during the 12-month submission period.
Updated instructions: Added: multigated acquisition scan (MUGA).
Updated denominator: Added: multigated acquisition scan (MUGA).
Updated denominator criteria: Added: coding for multigated acquisition scan (MUGA).
Measure Steward:
Hie;h Priority Measure:
Measure 'l'vne:
Rationale
Undated numerator: Added: multigated accmisition scan (MUGA).
American College ofCardiolo!!v Foundation
Yes
Efficiencv
We are proposing to update multiple components of the measure to add MUGA. Even though MUGA
scanning allows a clinician to evaluate many heart parameters and can be done while resting or under
stress, this diagnostic imaging test would ensure this type of imaging isn't performed on low-risk
surgery patients since the risks of the procedure exceed the expected clinical benefit for the
denominator eligible patient population. 156 The MUGA scan is primarily used for assessing
mvocardial function in oaticnts on cardiotoxic chemotheraov. 157
Winchester, D. E., Maron, D. J., Blankstein, R., Chang, I. C., Kirtane, A. J., Kwong, R. Y., Pellikka, P.A., Prutkin, J.
M., Russell, R., & Sandhu, A. T. (2023). ACC/AHA/ASE/ASNC/ASPC/HFSA/HRS/SCAI/SCCT/SCMR/STS 2023
Multimodality Appropriate Use Criteria for the Detection and Risk Assessment of Chronic Coronary
Disease. Journal of Cardiovascular Magnetic Resonance: Official Journal of the Society for Cardiovascular Magnetic
Resonance, 25(1), 58. https://doi.org/10.1186/s12968-023-00958-5.
157 Odak, M., & Kayani, W. T. (2023). MUGA Scan. In StatPearls. StatPearls Publishing.
https://www.ncbi.nlm.nih.gov/books/NBK564365/.
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D.31. Adult Sinusitis: Antibiotic Prescribed for Acute Viral Sinusitis (Overuse)
Substantive Change:
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Measure Steward:
High Priority Measure:
Measure Type:
Rationale
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Description
N/A/N/A
331
N/A
MIPS CQM Specifications
Percentage of patients, aged 18 years and older, with a diagnosis of acute viral sinusitis who were
prescribed an antibiotic within 10 davs after onset of symptoms.
Updated the instructions: Revised: This measure is to be submitted once for each occurrence of
acute viral sinusitis (AVS) during the performance period. Each unique occurrence starts with the
onset of AVS symptoms and concludes with the resolution of AVS symptoms or after 90 days if a
resolution ofAVS symptoms is not documented. If multiple encounters are documented within an
occurrence, Merit-based Incentive Payment System (MIPS) eligible clinicians should submit the most
recent encounter during that occurrence. A new occurrence of AVS cannot start until the previous
occurrence during the performance period has concluded.
American Academy ofOtolaryngology-Head and Neck Surgery Foundation
Yes
Process
We are proposing to update the measure instructions to clarify what constitutes an occurrence for the
purposes of this measure. This additional guidance would further clarify how patients are attributed to
the denominator of this measure for each eligible occurrence. This change would ensure consistency
in the abstraction of the measure's elements that support rigorous data for the calculation of MIPS
performance rates.
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Category
CBE # I eCQM CBE #:
Quality#:
CMSeCQMID:
Current Collection Tvoe:
Current Measure Description:
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62541
D.32. Maternity Care: Postpartum Follow-up and Care Coordination
Catee:ory
Description
CBE # / eCOM CBE #:
NIA/NIA
Quality#:
336
CMSeCOMID:
NIA
Current Collection Tvne:
MIPS COM Soecifications
Current Measure Description:
Percentage of patients, regardless of age, who gave birth during a 12-month period who were seen for
postpartum care before or at 12 weeks of giving birth and received the following at a postpartum
visit: breast-feeding evaluation and education, postpartum depression screening, postpartum glucose
screening for gestational diabetes patients, family and contraceptive planning counseling, tobacco use
screening and cessation education, healthy lifestyle behavioral advice, and an immunization review
and uodate.
The measure description is revised to read: Percentage of patients, regardless of age, who gave
birth during a 12-month period who were seen for postpartum care before or at 12 weeks of giving
birth and received the following at a postpartum visit: breastfeeding evaluation and education,
postpartum depression screening, intimate partner violence screening, postpartum glucose screening
for gestational diabetes patients, family and contraceptive planning counseling, tobacco use screening
and cessation education, healthy lifestyle behavioral advice, and an immunization review and update.
Substantive Change:
Updated numerator: Added: intimate partner violence screening.
Updated numerator definition: Added: Intimate Partner Violence Screening - Patients who were
screened for intimate partner violence before or at 12 weeks postpartum. Questions may be asked
either directly by a health care provider or in the form of self-completed paper-or computeradministered questionnaires, and results should be documented in the medical record. Intimate
partner violence screening should include a self-reported validated intimate partner violence
screening tool ( e.g., Abuse Assessment Screen (AAS), Extended - Hurt, Insult, Threaten, Scream (EHlTS), Humiliation, Afraid, Rape, Kick (HARK)).
Measure Steward:
Hi!!h Prioritv Measure:
Measure Tvne:
Rationale
Updated numerator instructions: Added: intimate partner violence screening.
Centers for Medicare & Medicaid Services
Yes
Process
We are proposing to update multiple measure components to include intimate partner violence
screening. "The effects of intimate partner violence (IPV) on maternal and neonatal outcomes are
multifaceted and largely preventable. " 158 This type of abuse has maternal and neonatal consequences
on mental and physical health that could be far reaching beyond the perinatal period; 159 therefore,
intimate partner violence screening is being proposed for inclusion. This revision would support
clinicians currently screening and would encourage others to begin screening for this risk within this
patient population as lPV may escalate during the postpartum period."'' The American College of
Obstetricians and Gynecologists recommend including screening for IPV at the postpartum checkup
to help identify patients experiencing lPV so that support may be offered to break this cycle, leading
to oositive outcomes for both maternal and neonatal health. 161
Alhusen, J. L., Ray, E., Sharps, P., & Bullock, L. {2015). Intimate Partner Violence During Pregnancy: Maternal and
Neonatal Outcomes. Journal of Women's Health (2002), 24(1), 100-106. https://doi.org/10.1089/jwh.2014.4872.
159 Chisholm, C. A., Bullock, L., & Ferguson, J.E. J., 2nd (2017). Intimate Partner Violence and Pregnancy:
Epidemiology and Impact. American Journal of Obstetrics and Gynecology, 217(2), 141-144.
https://doi.org/10.1016/j.ajog.2017 .05.042.
160 American College of Obstetricians and Gynecologists (ACOG). (2012). Committee on Health Care for
Underserved Women Opinion: Intimate Partner Violence. https://www.acog.org//media/project/acog/acogorg/clinical/files/committee-opinion/articles/2012/02/intimate-partner-violence.pdf.
161 See footnote ACOG, 2012.
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Catee:ory
CBE # / eCQM CBE #:
Quality#:
CMSeCOMID:
Current Collection Tvne:
Current Measure Descriptiou:
Substantive Change:
D.33. HIV Medical Visit Frequency
Description
NIA/NIA
340
NIA
MIPS COM Snecifications
Percentage of patients, regardless of age with a diagnosis of HIV who had at least one medical visit in
each 6 month period of the 24 month measurement period, with a minimum of60 days between
medical visits.
Modified collection type: eCQM Specifications, MIPS CQM Specifications collection type.
The measure title is revised from "HIV Medical Visit Frequency" to: HIV Annual Retention in
Care.
The measure description is revised to read: Percentage of patients, regardless ofage, with a
diagnosis of Human Immunodeficiency Virus (HIV) before or during the first 240 days of the
performance period who had at least two eligible encounters or at least one eligible encounter and
one HIV viral load test that were at least 90 days apart within the measurement period.
The measure denominator is revised to read: Patients, regardless of age, with a diagnosis of HIV
before or during the first 240 days of the performance period who had at least one eligible encounter
during the first 240 days of the performance period.
The measure denominator note is revised to read: Only patients with an eligible encounter in the
first 240 days are included in this measure to allow for sufficient time to complete a second eligible
encounter or viral load laboratory at least 90 days after the initial encounter during the performance
period.
Updated denominator criteria: Added: coding for telephone and home visit patient encounters.
Updated denominator exclusion: Removed: Patient died at any time during the 24-month
measurement period.
The measure numerator is revised to read: Number of patients who had at least one eligible
encounter and one HIV viral load test at least 90 days apart during the performance period, or who
had at least two eligible encounters at least 90 days apart during the performance period.
Updated numerator note: Added: A patient would be included in the measure numerator if they
have either 1) two eligible encounters at least 90 days apart, or 2) one eligible encounter and one viral
load test at least 90 days apart from each other. The encounter or encounters that cause a patient to be
included in the numerator do not need to include the encounter that caused the patient to be included
in the denominator.
Measure Steward:
Hie:h Prioritv Measure:
Measure Tvne:
Rationale
The measure numerator options are revised to read:
Performance Met: Patient had two eligible encounters at least 90 days apart or one eligible
encounter and one HIV viral load test at least 90 days apart
Performance Not Met: Patient did not have two eligible encounters at least 90 days apart or one
eli!!ible encounter and one HIV viral load test at least 90 days anart
Health Resources and Services Administration
Yes
Process
We are proposing to update the collection types available for this measure to include the eCQM
Specifications collection type to allow choice in submission method. We are also proposing to revise
multiple components of the measure allowing for improved quality outcome which is to engage
persons who are infected with HIV in regular HIV care that promote test-and-treat strategies. 162
In the event the proposed substantive change(s) are finalized, the substantive changes would not
allow for a direct comparison of performance data from prior years to performance data submitted
after the implementation of these substantive changes. As such, if the performance data submitted
meets the criteria for creation of a performance period benchmark, a new benchmark would be used
for scorin!!.
Gardner, E. M., Mclees, M. P., Steiner, J. F., Del Rio, C., & Burman, W. J. (2011). The Spectrum of Engagement in
HIV Care and its Relevance to Test-and-treat Strategies for Prevention of HIV Infection. Clinical Infectious Diseases:
An Official Publication of the Infectious Diseases Society of America, 52(6), 793-800.
https://doi.org/10.1093/cid/ciq243.
162
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D.34. Rate of Carotid Artery Stenting (CAS) for Asymptomatic Patients, Without Major Complications (Discharged to
Horne by Post-Operative Day #2)
Descri tion
Cate orv
CBE # / eCQM CBE #:
NIA/NIA
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
··-···-·-······················- ··-····-·········--······-···············-················-
Catel!orv
Quality#:
CMSeCQMID:
Current Collection !voe:
Current Measure Description:
··········-·······
Substantive Change:
62543
·················-·-·-···-····-·-··- ··-··-····-·······--················--·····- ···-····-···············-···········- ·······················-·- ·······-· ·······-··············-······--·············- -···········-··············-············-···- ·······-··-
Descriotion
344
NIA
MIPS COM Soecifications
Percent of asymptomatic patients undergoing CAS who are discharged to home no later than postooerative dav #2.
The measure title is revised from Rate of Carotid Artery Sten ting (CAS) for Asymptomatic
Patients, Without Major Complications (Discharged to Home by Post-Operative Day #2) to:
Rate of Carotid Endarterectomy (CEA) or Carotid Artery Stenting (CAS) for Asymptomatic Patients,
Without Major Complications (Discharged to Home by Post-Operative Day #2)
The measure description is revised to read: Percent of asymptomatic patients undergoing Carotid
Endarterectomy (CEA) or Carotid Artery Stenting (CAS) without major complication who are
discharged to home no later than post-operative day #2.
Updated instructions: Added: CEA.
Updated denominator: Added: CEA.
Updated denominator criteria: Added: coding for carotid endarterectomy.
Updated numerator: Added: CEA.
Updated numerator definition: Added: procedure for CEA or CAS.
Uodated numerator ootions: Added: CEA.
Measure Steward:
Hil!h Priority Measure:
Measure Tvoe:
Rationale
Societv for Vascular Surgeons
Yes
Outcome
We are proposing to revise this measure to include Carotid Endarterectomy (CEA) to assess for postoperative complications for asymptomatic patients who had CEA. CEA for asymptomatic carotid
stenosis reduces the risk ofipsilateral stroke, and any stroke, by approximately 30% over 3 years. 163
Previously, assessment of outcomes for CEA procedures was a separate measure. As both procedures
are appropriate for treating asymptomatic carotid artery stenosis, these measures are being combined
so that a full picture of positive outcomes can be captured for this patient population. 164 Additionally,
by combining these measures the denominator eligible patient population may increase allowing for
more robust data for participating MIPS clinicians.
In the event the proposed substantive change(s) are finalized, the substantive changes would not
allow for a direct comparison of performance data from prior years to performance data submitted
after the implementation of these substantive changes. As such, if the performance data submitted
meets the criteria for creation of a performance period benchmark, a new benchmark would be used
for scoring.
Chambers, B. R., & Donnan, G. A. (2005). Carotid Endarterectomy for Asymptomatic Carotid Stenosis. The
Cochrane Database of Systematic Reviews, 2005(4), CD001923.
https://doi.org/10.1002/14651858.CD001923. pub 2.
164 Wang, J., Bai, X., Wang, T., Dmytriw, A. A., Patel, A. B., & Jiao, L. (2022). Carotid Stenting Versus Endarterectomy
for Asymptomatic Carotid Artery Stenosis: A Systematic Review and Meta-Analysis. Stroke, 53(10), 3047-3054.
https://doi.org/10.1161/STROKEAHA.122.038994.
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D.35. Unplanned Reoperation within the 30-Day Postoperative Period
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Substantive Change:
Measure Steward:
High Prioritv Measure:
Measure Tvpe:
Rationale
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Descriotion
NIA/NIA
355
NIA
MIPS CQM Specifications
Percentage of patients aged 18 years and older who had any unplanned reoperation within the 30 day
oostooerative oeriod.
Updated denominator criteria: Revised: coding for fissurectomy, including sphincterotomy.
American College of Surgeons
Yes
Outcome
We are proposing to update denominator criteria to revise coding for fissurectomy, including
sphincterotomy as this is an operative procedure that could have complications requiring unplanned
reooeration within 30 davs oostooerativelv.
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CBE # / eCQM CBE #:
Quality#:
CMSeCQMID:
Current Collection Tvpe:
Current Measure Description:
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62545
D.36. Optimizing Patient Exposure to Ionizing Radiation: Count of Potential High Dose Radiation Imaging Studies:
Computed Tomography (CT) and Cardiac Nuclear Medicine Studies
Catee;ory
Description
CBE # / eCOM CBE #:
N/A/N/A
Qnalitv II:
360
CMSeCQMID:
N/A
Current Collection Tvoe:
MIPS COM Soecifications
Current Measure Description:
Percentage of computed tomography (CT) and cardiac nuclear medicine (myocardial perfusion
studies) imaging reports for all patients, regardless of age, that document a count of known previous
CT (any type of CT) and cardiac nuclear medicine (myocardial perfusion) studies that the patient has
received in the 12-month oeriod nrior to the current studv.
The measure description is revised to read: Percentage of computed tomography (CT) and cardiac
nuclear medicine (myocardial perfusion or infarct avid imaging) reports for all patients, regardless of
age, that document a count of known previous CT (any type of CT) and cardiac nuclear medicine
(myocardial perfusion or infarct avid imaging) studies that the patient has received in the 12-month
period prior to the current study.
Substantive Change:
The measure denominator is revised to read: All final reports for patients, regardless of age,
undergoing a CT or cardiac nuclear medicine (myocardial perfusion or infarct avid imaging)
procedure.
Updated denominator criteria: Added: coding for cardiology infarct imaging.
The measure numerator is revised to read: CT and cardiac nuclear medicine (myocardial perfusion
or infarct avid imaging) reports that document a count of known previous CT (any type of CT) and
cardiac nuclear medicine (myocardial perfusion or infarct avid imaging) studies that the patient has
received in the 12-month period prior to the current study.
Updated numerator instructions: Added: infarct avid imaging.
The measure numerator options are revised to read:
Performance Met: Count of previous CT (any type of CT) and cardiac nuclear medicine (myocardial
Measure Steward:
High Prioritv Measure:
Measure Type:
Rationale
perfusion or infarct avid imaging) studies documented in the 12-month period prior to the current
study.
Performance Not Met: Count of previous CT and cardiac nuclear medicine (myocardial perfusion or
infarct avid imaging) studies not documented in the 12-month period prior to the current study,
reason not given.
American College of Radiologv
Yes
Process
We are proposing to revise multiple components of this measure to include infarct avid imaging in the
cardiac nuclear medicine imaging study that involves the use of radiation, including a radiotracer or
contrast agent and/or Imaging modalities, such as positron emission tomography (PET), singlephoton emission computed tomography (SPECT), or magnetic resonance imaging (MRl). 165 Given
that this imaging can expose a patient to potentially high doses of radiation, 166 including it in the
denominator of this measure requires the clinician to document a more complete count of previous
cardiac nuclear medicine imaging studies, increasing patient safety by preventing continued exposure
to radiation.
Enabnit, A. & Warren, A. (2023). Infarct Avid Imaging Study: Purpose, Procedure, and Applications.
https://www.dovemed.com/hea lth-topics/focused-health-topics/infarct-avid-imaging-study-purpose-procedu reand-applications.
166 Salah, H., Alkhorayef, M., Jambi, L., Almuwannis, M., & Sulieman, A. (2023). Radiation Dose to Patients and
Public Exposure in Cardiac Rest and Stress Single Photon Emission Computed Tomography Examinations. Radiation
Physics and Chemistry. https://doi.org/10.1016/j.radphyschem.2023.111383.
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D.37. Closing the Referral Loop: Receipt of Specialist Report
Category
CBE # I eCQM CBE #:
Quality#:
CMSeCQMID:
Current Collection Tvoe:
Current Measure Description:
Description
NIAi NIA
374
CMS50vl3
eCOM Soecifications / MIPS COM Specifications
Percentage of patients with referrals, regardless of age, for which the referring clinician
receives a report from the clinician to whom the patient was referred.
Updated denominator criteria: For all collection types: Added: coding for psychology and
neuropsychology.
Substantive Change:
The measure numerator definition is revised to read: For the MIPS CQM Specifications
collection type: Revised: A written document prepared by the eligible clinician (and staff) to
whom the patient was referred and that accounts for their findings, provides summary of care
information about findings, diagnostics, assessments and/or plans of care, or states the patient
did not attend the appointment, and is provided to the referring eligible clinician.
Centers for Medicare & Medicaid Services
Yes
Process
We are proposing to add psychology and neuropsychology encounter codes to the denominator
criteria as this measure is applicable to their scope of care. This expansion of the denominator
would allow more clinician types to submit the measure leading to an increase in denominator
eligibility, capturing a more complete patient population, as it is clinically appropriate for
these clinician types to complete the quality action for a patient referred to a specialist.
Measure Steward:
High Prioritv Measure:
Measure Tvpe:
Rationale
We are proposing to revise the numerator definitions for the MIPS CQM Specifications
collection type to clarify which information should be included in the referring clinician's
report to successfully close the referral loop. This revision increases clarity of this element and
ensures consistent implementation allowing for more comparable data.
D.38. Functional Status Assessment for Total Hip Replacement
Category
CBE # I eCQM CBE #:
Quality#:
CMSeCQMID:
Current Collection Tvpe:
Current Measure Description:
Substantive Change:
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Measure Steward:
Hil!h Prioritv Measure:
Measure Type:
Rationale
Description
NIA/NIA
376
CMS56v13
eCQM Specifications
Percentage of patients 19 years of age and older who received an elective primary total hip
arthroplasty (THA) and completed a functional status assessment within 90 days prior to the surgery
and in the 300 - 425 days after the surgery.
Updated initial patient population: Revised: encounter timeframe from November of the year prior
to August of the vear prior.
Centers for Medicare & Medicaid Services
Yes
Process
We are proposing to revise initial patient population by changing the timing of the encounter to better
align with the post-surgical assessment timeframe of 300 to 425 days atler the original THA surgery.
This would also harmonize the timeframe of the patient encounter with the administrative claims
measure "Hospital-Level Risk-Standardized Complication Rate (RSCR) Following Elective Primary
Total Hip Arthroplasty (THA) and/or Total Knee Arthroplasty (TKA)" available for Hospital
Inpatient Quality Reporting (88 FR 59067 through 59070), thereby aligning timing specificity and
patterns across similar measures. Measure alignment, in accordance with clinical recommendations,
guidelines, and best practices, allows for consistent and comparable data points, which leads to
actionable data to drive quality care, through understanding where the gaps in care are within a
patient population or along the continuum of care.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
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D.39. Adherence to Antipsychotic Medications For Individuals with Schizophrenia
Cate2ory
CBE # / eCOM CBE #:
Quality#:
CMSeCOMID:
Current Collection Tvne:
Current Measure Description:
Substantive Change:
Measure Steward:
Hi!!h Prioritv Measure:
Measure Tvne:
Rationale
Description
1879/N/A
383
NIA
MIPS COM Snecifications
Percentage of individuals at least 18 years of age as of the beginning of the performance period with
schizophrenia or schizoaffcctive disorder who had at least two prescriptions filled for any
antipsychotic medication and who had a Proportion of Days Covered (PDC) of at least O.8 for
antinsvchotic medications during the nerformance neriod.
Updated denominator note: Removed: distinction of typical versus atypical, 'days' supply' notation,
and medication HCPCS codes.
Undated denominator criteria: Removed: HCPCS coding from nrescrintion criteria.
Centers for Medicare & Medicaid Services
Yes
Intermediate Outcome
We are proposing to remove "days' supply" and HCPCS (J codes) from the list of anti psychotic
medications in the measure. This revision would ensure inclusion for any duration of the listed long
acting injectables permitting the clinician, or site, to obtain days' supply infonnation from any
appropriate clinical or administrative source, thus aligning the calculation of PDC with all
appropriate medications listed in the measure. This revision reduces the burden of collecting this
aspect of the measure from medical records. Decreasing complexity and burden of this element
ensures consistent implementation allowing for more comparable data.
Cleveland Clinic. (2023). Antipsychotic Medications. https://my.clevelandclinic.org/health/treatments/24692antipsychotic-medications.
167
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Finally, we are proposing to remove "typical" and "atypical" as part of the subheadings of the lists of
antipsychotic medications as this distinction does not apply to the list of oral and long-acting
injectable antipsychotic medications listed under each of the categories which include both typical
and atypical medications. 167
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D.40. Adult Primary Rhegmatogenous Retinal Detachment Surgery: No Return to the Operating Room Within 90 Days
of Surgery
Category
CBE # I eCQM CBE #:
Quality#:
CMSeCQMID:
Current Collection Type:
Current Measure Description:
Substantive Change:
Description
NIA/NIA
384
NIA
MIPS COM Specifications
Patients aged 18 years and older who had surgery for primary rhegmatogenous retinal detachment
who did not require a return to the operating room within 90 days of surgery.
Updated instructions: Revised: timeframe for when surgery for primary rhegmatogenous retinal
detachment must have occurred to meet the denominator criteria.
Updated numerator note: Added: For the purposes of meeting the numerator, complications are
onlv those related to the following procedures: 67107, 67108, 67110.
American Academv of Ophthalmology
Yes
Outcome
We are proposing to update the instructions to clarify that surgery for primary rhegmatogenous retinal
detachment must occur between January 1st and September 30 th of the performance period to allow 90
days after the surgery to assess for the numerator action for patients who have surgeries performed by
September 30 th . We are also proposing to add a numerator note to clarify that the numerator is not
required to capture only procedures covered by the three original procedure codes in the denominator,
but rather anv procedure that is related to complications arising from the original procedures listed.
Measure Steward:
High Prioritv Measure:
Measure Tvpe:
Rationale
D.41. Amvotroohic Lateral Sclerosis (ALS) Patient Care Preferences
Categorv
CBE # I eCQM CBE #:
Qualitv#:
CMSeCQMID:
Current Collection Type:
Current Measure Description:
Substantive Change:
Measure Steward:
High Priority Measure:
Measure Type:
Rationale
Description
NIA/NIA
386
NIA
MIPS CQM Specifications
Percentage of patients diagnosed with Amyotrophic Lateral Sclerosis (ALS) who were offered
assistance in planning for end of life issues (e.g., advance directives, invasive ventilation, lawful
physician-hastened death, or hospice) or whose existing end of life plan was reviewed or updated at
least once annually or more frequency as clinically indicated (i.e., rapid progression)
Updated denominator criteria: Added: coding for speech language pathology.
American Academy ofNeurology
Yes
Process
We are proposing to update the denominator criteria to include coding for speech language pathology
and nuclear medicine as this measure is applicable to their scope of care.
D.42. Infection within 180 Days of Cardiac Implantable Electronic Device (CIED) Implantation, Replacement, or
Revision
Categorv
CBE # I eCQM CBE #:
Qualitv #:
CMSeCQMID:
Current Collection Type:
Current Measure Description:
Substantive Change:
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Measure Steward:
High Priority Measure:
Measure Type:
Rationale
Description
NIA/NIA
393
NIA
MIPS CQM Specifications
Infection rate following CIED device implantation, replacement or revision.
Updated instructions: Added: A new device would be either the first device OR a device implanted
with new functionalitv.
American College ofCardiologv Foundation
Yes
Outcome
We are proposing to update the measure instructions to clarify the definition of a new device. This
change would ensure alignment and consistency in the abstraction of the measure's elements that
support rigorous data for the calculation of MIPS performance rates.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62549
D.43. Door to Puncture Time for Endovascular Stroke Treatment
Catee:ory
CBE # I eCQM CBE #:
Quality#:
CMSeCOMID:
Current Collection Tvne:
Current Measure Description:
Substantive Change:
Esenwa, C., & Gutierrez, J. (2015). Secondary Stroke Prevention: Challenges and Solutions. Vascular Health and
Risk Management, 11, 437-450. https://doi.org/10.2147/VHRM.563791.
169 Medical News Today. (2023). Recurrent Strokes: What to Know.
https://www. medica lnewstoday.com/articles/recurrent-strokes.
168
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Measure Steward:
Hil!:b Prioritv Measure:
Measure Tvne:
Rationale
Description
NIA/NIA
413
NIA
MIPS COM Snecifications
Percentage of patients undergoing endovascular stroke treatment who have a door to puncture time of
90 minutes or less.
Updated denominator exclusion: Added: Patients with secondary stroke within 5 days of the initial
procedure.
Societv oflnterventional Radiology
Yes
Intermediate Outcome
We are proposing to add a denominator exclusion to remove patients with secondary stroke, such as
those which may occur with vasospasm in the setting of subarachnoid hemorrhage. Treatment for an
initial stroke is most effective when administered very shortly after the onset ofsymptoms. 168
However, the same is not the case for secondary stroke which is more challenging to manage as
patients with secondary stroke may already be on "blood thinners or aspirin, medication to control
cholesterol, or drugs to lower blood pressure" as a result of the initial stroke and "experience more
severe and long-lasting disability." 169 This additional exclusion would more precisely reflect the time
to reperfusion for obtaining favorable outcomes in cerebral revascularization within the target patient
population.
62550
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
D.44. Osteoporosis Management in Women Who Had a Fracture
Cateeorv
CBE # I eCQM CBE #:
Qualitv #:
CMSeCQMID:
Current Collection Tvoe:
Current Measure Description:
Substantive Change:
Description
0053 !NIA
418
NIA
Medicare Part B Claims Measure Specifications/ MIPS CQM Specifications
The percentage of women 50-85 years of age who suffered a fracture and who had either a bone
mineral density (BMD) test or prescription for a drug to treat osteoporosis in the six months after the
fracture.
The measure description is revised to read: For all collection types: The percentage of women 5085 years of age who suffered a fracture and who had either a bone mineral density (BMD) test or
prescription for a drug to treat osteoporosis in the 180 days after the fracture.
Updated instructions: For all collection types: Revised: from six months to 180 days.
Updated denominator exclusion: For all collection types: Removed: specific encounter
requirements from the frailty/advanced illness exclusion.
The measure numerator is revised to read: For all collection types: Patients who received either a
bone mineral density test or a prescription for a drug to treat osteoporosis in the 180 days after the
fracture.
National Committee for Oualitv Assurance
No
Process
Measure Steward:
Hie;h Priority Measure:
Measure Type:
We are proposing to use both 6 months and 180 days within the measure denominator and numerator
to allow for the appropriate time anchors. In the denominator, 6 months is used so that the
measurement period to identify a fracture is always July I - June 30 (during the 6 months prior to the
performance period through June 30 of the performance period). The numerator action of
administration ofa bone mineral density test or a prescription for a drug to treat osteoporosis within a
specific number of days (180 days after the date of a fracture) rather than months with varying
number of days (e.g., 28- 31 days).
Rationale
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We are proposing to update the denominator exclusion by removing the requirement for patients to
have had at least one inpatient or two outpatient encounters to recognize a diagnosis of advanced
illness. The removal of this requirement within the denominator exclusion reduces the burden of
identifying applicable encounters, while still identifying patients with an indication of frailty. This is
particularly applicable for those patients seen outside of their reporting clinician's medical record.
This revision would update the denominator exclusion to remove any patient 66-80 years of age and
older who has a diagnosis of advanced illness during the measurement period or the year prior from
the denominator of measure Q418. Decreasing complexity and burden of this element ensures
consistent imolementation allowing for more comoarable data.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62551
Paty, J., Turner-Bowker, D. M., Elash, C. A., & Wright, D. (2016). The WSymQ® Instrument: Use of a New
Patient-Reported Outcome Measure for Assessment of Varicose Vein Symptoms. Phlebo/ogy, 31(7), 481-488.
https://doi.org/10.1177/0268355515595193.
170
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D.45. Varicose Vein Treatment with Saphenous Ablation: Outcome Survey
Catee:ory
Description
CBE # I eCQM CBE #:
NIA/NIA
Quality#:
420
NIA
CMSeCOMID:
Current Collection Tvne:
MIPS COM Snecifications
Current Measure Description:
Percentage of patients treated for varicose veins (CEAP C2-S) who are treated with saphenous
ablation (with or without adjunctive tributary treatment) that report an improvement on a disease
soecific oatient reoorted outcome survev instrument after treatment
Substantive Change:
Updated numerator definition: Added: Varicose Veins Symptom Questionnaire (VVSymQ) and
Venous Clinical Severity Score (VCSS).
Measure Steward:
Society of lnterventional Radiology
Hil!h Prioritv Measure:
Yes
Measure Type:
Patient-Reoorted Outcome-Based Performance Measure
Rationale
We are proposing to revise the definition of an 'Outcome Survey' to include the VVSymQ and VCSS.
These outcome surveys measure improvement for saphenous vein ablation and would allow
clinicians more choices for meeting the numerator, which may encourage further adoption of this
measure. 170
62552
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
D.46. Proportion of Patients Sustaininl! a Bladder Iniurv at the Time of anv Pelvic Orl!an Prolapse Repair
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Descrintion
NIA/NIA
432
NIA
MIPS CQM Specifications
Percentage of patients undergoing pelvic organ prolapse repairs who sustain an injury to the bladder
reco!!nized either during or within 30 davs after surgerv.
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Cate!!orv
CBE # I eCQM CBE #:
Qualitv#:
CMSeCQMID:
Current Collection Type:
Current Measure Description:
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
-························-··········-
Substantive Change:
62553
························································-·--·················-··························-·····-······················--·-·················-·····
The measure title is revised from Proportion of Patients Sustaining a Bladder Injury at the
Time of any Pelvic Organ Prolapse Repair to: Proportion of Patients Sustaining a Bladder or
Bowel Injury at the time of any Pelvic Organ Prolapse Repair.
The measure description is revised to read: Percentage of patients undergoing surgical repair of
pelvic organ prolapse that is complicated by a bladder or bowel injury at the time of index surgery
that is recognized intraoperatively or within 30 days after surgery.
The measure instructions are revised to read: This measure is to be submitted each time an
anterior, posterior, or apical prolapse repair surgery is performed from December 1st of the previous
performance period through November 30th of the current performance period. There is no diagnosis
associated with this measure. This measure may be submitted by Merit-based Incentive Payment
System (MIPS) eligible clinicians who perform the quality actions described in the measure based on
the services provided and the measure-specific denominator coding.
This measure will be calculated with 2 performance rates:
I) Percentage of patients undergoing prolapse repair who sustain a bladder injury that necessitates
repair either intraoperatively or within 30 days after surgery.
2) Percentage of patients undergoing prolapse repair who sustain a bowel injury that necessitates
repair either intraoperatively or within 30 days after surgery.
Submission of the two performance rates is required for this measure. A simple average, which is the
sum of the performance rates divided by the number of the performance rates will be used to
calculate performance.
THERE ARE TWO SUBMISSION CRITERIA FOR THIS MEASURE:
I) All patients undergoing anterior or apical pelvic organ prolapse (POP) surgery who sustain a
bladder injury.
2) All patients undergoing anterior, posterior, or apical pelvic organ prolapse (POP) surgery who
sustain a bowel injury.
This measure contains two submission criteria which together ensure that the proper evaluation and
treatment is provided for patients who undergo pelvic organ prolapse repair. Submission Criteria I
evaluates whether patients sustained a bladder injury intraoperatively or within 30 days after surgery.
Submission Criteria 2 evaluates whether patients sustained a bowel injury intraoperatively or within
30 days after surgery. Patients who undergo a procedure that meets the denominator of both
submission criteria should be included in both and assessed for each clinical outcome.
Updated denominator: Added: SUBMISSION CRITERIA 2:
All patients undergoing anterior, posterior, or apical pelvic organ prolapse (POP) surgery.
Updated denominator criteria: Added: SUBMISSION CRITERIA 2:
All patients, regardless of age
AND
Patient procedure during the denominator identification period
WITHOUT
Telehealth Modifier
Updated definition: Added: SUBMISSION CRITERIA I & 2: Denominator identification period-
the twelve month period in which eligible patients have a procedure, which December 1st of the
previous performance period through November 30th of the current performance period.
Updated numerator:
Revised: SUBMISSION CRITERIA 1:
Percentage of patients undergoing prolapse repair who sustain a bladder injury that necessitates repair
either intraoperatively or within 30 days after surgery.
Added: SUBMISSION CRITERIA 2:
Percentage of patients undergoing prolapse repair who sustain a bowel injury that necessitates repair
either intraoperatively or within 30 days after surgery.
Update numerator instructions: Added: SUBMISSION CRITERIA 2:
INVERSE MEASURE - A lower calculated performance rate for this measure indicates better
clinical care or control. The "Performance Not Met" numerator option for this measure is the
representation of the better clinical quality or control. Submitting that numerator option will produce
a performance rate that trends closer to 0%, as quality increases. For inverse measures, a rate of
!00% means all of the denominator eligible patients did not receive the appropriate care or were not
in proper control.
Updated numerator options: Added: SUBMISSION CRITERIA 2:
Performance Met: Patient sustained bowel injury at the time of surgery or discovered subsequently up
to 30 days post-surgery
_ _ _ _ _ _ _ _ _ _ _ _ _,.L
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Updated numerator note: Added: SUBMISSION CRITERIA 2:
In order to meet the measure, bowel injury is sustained as a result of the prolapse surgery.
62554
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
Catee;ory
Description
Denominator Exception: Docwnented medical reasons for not reporting bowel injury (e.g.
gynecologic or other pelvic malignancy documented, planned (e.g. not due to an unexpected bowel
injury) resection and/or re-anastomosis of bowel, or patient death from non-medical causes not
related to surgery, patient died during procedure without evidence of bowel injury)
OR
Performance Not Met:Patient did not sustain a bowel injury at the time of surgery nor discovered
subsequently up to 30 days post-surgery
American Urogynecologic Society
Yes
Outcome
We are proposing to revise this measure to add a submission criteria and performance rate for
patients who retain a bowel injury at the time of any pelvic organ prolapse repair. We are proposing
to add submission criteria two to evaluate all patients undergoing anterior, posterior, or apical pelvic
organ prolapse surgery who sustain a bowel injury.
Measure Steward:
Hieh Priority Measure:
Measure Type:
Rationale
Previously, assessment of bowel injury outcomes for POP procedures was a separate measure. As
both measures are assessing for adverse outcomes following POP procedures, these measures are
being combined so that a full picture of adverse outcomes can be captured for this patient population.
Additionally, by combining these measures, the denominator eligible patient population may increase
allowing for more robust data for participating MIPS clinicians.
We are also proposing to add a definition for the denominator identification period of December I st
of the previous performance period through November 30th of the current performance period.
In the event the proposed substantive change(s) are finalized, the substantive changes would not
allow for a direct comparison of performance data from prior years to performance data submitted
after the implementation of these substantive changes. As such, if the performance data submitted
meets the criteria for creation of a performance period benchmark, a new benchmark would be used
for scoring.
D.47. Appropriate Workup Prior to Endometrial Ablation
Category
CBE # I eCQM CBE #:
Quality#:
CMSeCQMID:
Current Collection Tvpe:
Current Measure Description:
Substantive Change:
448
N/A
MIPS CQM Specifications
Percentage of patients, aged 18 years and older, who undergo endometrial sampling or hysteroscopy
with biopsy and results are documented before undergoing an endometrial ablation.
Updated the instructions: Revised: submission of the measure to once per performance period.
EP31JY24.525
Centers for Medicare & Medicaid Services
Yes
Process
We are proposing to change the frequency of this measure from each time a procedure for
endometrial ablation is performed to once per performance period, as this is more aligned with the
clinical action being assessed for this measure.
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Measure Steward:
High Priority Measure:
Measure Type:
Rationale
Description
N/A/N/A
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62555
D.48. Appropriate Treatment for Patients with Stage I (Tlc) - III HER2 Positive Breast Cancer
Catee:ory
CBE # / eCQM CBE #:
Quality#:
CMSeCOMID:
Current Collection Tvne:
Current Measure Description:
Substantive Change:
Description
1858/N/A
450
NIA
MIPS COM Snecifications
Percentage offemale patients aged 18 to 70 with stage I (Tlc) - Ill HER2 positive breast cancer for
whom appropriate treatment is initiated.
The measure description is revised to read: Percentage of patients aged 18 to 70 with stage I (Tlc)
- III HER2 positive breast cancer for whom appropriate treatment is initiated.
The measure denominator is revised to read: All breast cancer patients aged 18 to 70 with
pathologic stage 1 (Tlc)- Ill HER2 positive breast cancer diagnosed between July 1st of the previous
performance period through June 30th of the current performance period.
Updated denominator instructions: Added: For the purposes of this measure, only pathologic
staging and HER-2 testing performed between July 1st of the previous performance period through
June 30th of the current performance period will be included in the denominator of this measure.
Updated denominator note: Added: This measure includes both female and male breast cancers.
While treatment recommendations for males have largely been extrapolated from results of clinical
trials focused on breast cancer in females, management of breast cancer in males is similar in overall
management to breast cancer in females. Consistent with guidance in NCCN guideline
recommendations for aqjuvant systemic therapy, chemotherapy with/without HERZ-targeted therapy
should be recommended for males with breast cancer according to guidelines for females with breast
cancer.
Updated denominator criteria: Revised: Patients age 18-70 years on date of encounter
Added: diagnosis codes for male breast cancer.
Added: Diagnosis of breast cancer between July 1st of the previous performance period through June
30th of the current performance period.
Measure Steward:
High Priority Measure:
Measure Tvoe:
Rationale
Updated numerator note: Added: The timeframe to identify the adjuvant treatment course is within
six months of breast cancer pathologic staging. To satisfy the numerator, both chemotherapy and
HERZ-taroeted therapy must occur within six months of pathologic staging.
American Societv of Clinical Oncolol!v
Yes
Process
We are proposing to update multiple components of this measure to ensure that all patients diagnosed
with breast cancer are included in the measure's denominator. While treatment recommendations for
males have largely been extrapolated from results of clinical trials focused on breast cancer in
females, 171 management of breast cancer in males is similar in overall management to breast cancer in
females. Consistent with guidance in NCCN reeommendations for adjuvant systemic therapy,
chemotherapy with/without HERZ-targeted therapy should be recommended for males with breast
cancer according to guidelines for females with breast cancer. 172
Additionally, revisions to the denominator definition would clarify the timeframe in which pathologic
staging and HER-2 testing should be performed for patient to be included in the denominator. We are
also proposing revisions to the numerator note to further clarify definition of and timeframe for when
adiuvant treatment, for the ourooses of this measure, should occur relative to oatholol!ic stal!inl!.
Hassett, M. J., Somerfield, M. R., & Giordano, S. H. (2020). Management of Male Breast Cancer: ASCO Guideline
Summary. JCO Oncology Practice, 16(8), e839-e843. https://doi.org/10.1200/JOP.19.00792.
172 Gradishar, W. J., Moran, M. S., Abraham, J., Abramson, V., Aft, R., Agnese, D., Allison, K. H., Anderson, B.,
Burstein, H.J., Chew, H., Dang, C., Elias, A. D., Giordano, S. H., Goetz, M. P., Goldstein, L. J., Hurvitz, S. A.,
Jankowitz, R. C., Javid, S. H., Krishnamurthy, J., Leitch, A. M., ... Kumar, R. (2023). NCCN Guidelines® Insights: Breast
Cancer, Version 4.2023. Journal of the National Comprehensive Cancer Network: JNCCN, 21(6), 594-608.
https://doi.org/10.6004/jnccn.2023.0031.
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171
62556
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
D.49. RAS (KRAS and NRAS) Gene Mutation Testing Performed for Patients with Metastatic Colorectal Cancer who
Receive Anti-eoidermal Growth Factor Receotor (EGFR) Monoclonal Antibodv Theraov
Substantive Change:
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Hil!h Prioritv Measure:
Measure Type:
Rationale
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Description
1859/N/A
451
NIA
MIPS COM Specifications
Percentage of adult patients (aged 18 or over) with metastatic colorectal cancer who receive antiepidermal growth factor receptor monoclonal antibody therapy for whom RAS (KRAS and NRAS)
gene mutation testing was performed.
Updated denominator instructions: Added: The denominator of this measure is intended to capture
newly diagnosed stage IV patients or patients who have distant metastases at the time of colon cancer
diagnosis. For the purposes of this measure, the patient's initial diagnosis may occur between
December 1 of the prior year through November 30 of the performance period, and anti-EGFR
monoclonal antibody therapy may occur between December 1 of the prior year through December 31
of the performance period.
American Societv of Clinical Oncology
No
Process
We are proposing to add denominator instructions to clarify that only patients who have been newly
diagnosed with Stage IV colorectal cancer or patients who have distant metastases at the time of
colon cancer diagnosis are to be captured in the denominator of the measure. This would ensure that
the aPProPriate Patient POPUiation is assessed for the numerator action.
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Category
CBE # I eCQM CBE #:
Quality#:
CMSeCQMID:
Current Collection Type:
Current Measure Description:
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62557
D.50. Bone Density Evaluation for Patients with Prostate Cancer and Receiving Androgen Deprivation Therapy
Cate2orv
CBE # / eCQM CBE #:
Quality#:
CMSeCOMID:
Current Collection Tvne:
Current Measure Description:
Substantive Change:
462
CMS645v8
eCOM Snecifications
Patients determined as having prostate cancer who are currently starting or undergoing androgen
deprivation therapy (ADT), for an anticipated period of 12 months or greater and who receive an
initial bone density evaluation. The bone density evaluation must be prior to the start of ADT or
within 3 months of the start of ADT.
The measure denominator is revised to read: Patients with a qualifying encounter in the
measurement period AND with a diagnosis of prostate cancer AND with an order for ADT or an
active medication of ADT with an intent for treatment greater than or equal to 12 months during the
measurement period AND order for ADT in 3 months before to 9 months after the start of the
measurement oeriod.
Orel!;on UroloJ!;y Institute
No
Process
We are proposing to expand the denominator to include all patients regardless of gender. This
revision broadens the denominator population to capture all patients with a diagnosis of prostate
cancer who are receiving androgen deprivation therapy and ensure a bone density evaluation is
completed prior to the start of treatment. As significantly lower PSA screening rates were seen among
transgender individuals for ages 40-54 and 55-69, but higher rates within the age group 70-80
(P.B<.B.001 for all), 173 broadening the denominator would ensure these patient populations are being
screened in accordance with current clinical guidelines.
173 Premo, H., Gordee, A., Lee, H.J., Scales, C. D., Moul, J. W., & Peterson, A. {2023). Disparities in Prostate Cancer
Screening for Transgender Women: An Analysis of the MarketScan Database. Urology, 176, 237-242.
https://doi .org/10.1016/j .urology .2023.03.016.
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Measure Steward:
Hil!h Prioritv Measure:
Measure Tvne:
Rationale
Description
NIA/NIA
62558
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
D.51. Otitis Media with Effusion: Systemic Antimicrobials -Avoidance oflnappropriate Use
Category
CBE # I eCQM CBE #:
Quality#:
CMSeCQMID:
Current Collection Type:
Current Measure Description:
Description
0657 !NIA
464
NIA
MIPS CQM Specifications
Percentage of patients aged 2 months through 12 years with a diagnosis of OME who were not
prescribed systemic antimicrobials.
The measure instructions are revised to read: This measure is to be submitted once for each
occurrence ofotitis media with effusion (OME) in children seen during the performance period. Each
unique occurrence starts with the onset ofOME symptoms and concludes with the resolution ofOME
or after 90 days if a resolution of OME symptoms is not documented. If multiple encounters are
documented within an occurrence, Merit-based Incentive Payment System (MIPS) eligible clinicians
should submit the most recent encounter during that occurrence. A new occurrence of OME cannot
start until the previous occurrence during the performance period has concluded.
Substantive Change:
American Academy ofOtolarvngology- Head and Neck Surgery Foundation
Yes
Process
We are proposing to update the measure instructions to clarify what constitutes an occurrence for the
purposes of this measure. This additional guidance would further clarify how patients are attributed to
the denominator of this measure for each eligible occurrence. This change would ensure consistency
in the abstraction of the measure's elements that support rigorous data for the calculation of MIPS
performance rates.
Measure Steward:
Hi!!h Prioritv Measure:
Measure Tvne:
Rationale
D.52. Functional Status After Primary Total Knee Replacement
Cate2ory
CBE # I eCQM CBE #:
Qualitv#:
CMSeCQMID:
Current Collection Tvne:
Current Measure Description:
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Substantive Change:
Measure Steward:
Hil!h Priority Measure:
Measure Tvpe:
Rationale
Description
NIA/NIA
470
NIA
MIPS COM Soecifications
For patients age 18 and older who had a primary total knee replacement procedure, functional status
is rated by the patient as greater than or equal to 37 on the Oxford Knee Score (OKS) or a 71 or
greater on the KOOS, JR. tool at one year (9 to 15 months) postoperatively.
Updated numerator note: Revised: list of situations that denote performance not met.
Minnesota Community Measurement
Yes
Patient-Reported Outcome-Based Performance Measure
We are proposing to revise the numerator note by clarifying that if a tool other than the Oxford Knee
Score (OKS) or Knee injury/Osteoarthritis Outcome Score Joint Replacement (KOOS, JR.) is used to
assess a patient's functional status for this measure, it would result in a performance not met. The
requirements for meeting this measure require use of the specific tools referenced in the measure
specification, as they have been tested, validated, and determined to be most appropriate for capturing
the numerator action.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62559
D.53. Psoriasis - Improvement in Patient-Reported Itch Severity
Category
CBE # I eCQM CBE #:
Quality#:
CMSeCQMID:
Current Collection Type:
Current Measure Description:
Substantive Change:
Description
NIA/NIA
485
NIA
MIPS CQM Specifications
The percentage of patients aged 8 years and older, with a diagnosis of psoriasis where at an initial
(index) visit have a patient-reported itch severity assessment performed, score greater than or equal to
4, and who achieve a score reduction of 3 or more points at a follow-up visit.
Updated denominator note: Added: The initial (index) visit assessment and the follow-up visit for
assessment must occur during the performance period. The initial (index) visit is the first encounter
with the patient during the performance period. Every visit after the initial (index) visit during the
performance period is a follow-up visit. An assessment should be completed at each visit.
Updated numerator instructions: Removed: lfa patient has multiple follow-up visits within the
measurement period the last (most recent) visit should be used.
American Academy of Dermatology
Yes
Patient-reported Outcome-based Performance Measure
We are proposing to update the denominator note to clarify encounter timing by including language
outlining that a patient's first visit during the measurement period is considered the initial (index)
encounter. Each visit after the initial (index) visit during the measurement period would be deemed a
follow-up visit used to determine the outcome of the measure. This change would ensure consistency
in the abstraction of the measure's elements that support rigorous data for the calculation of MIPS
performance rates.
Measure Steward:
Hi!!h Prioritv Measure:
Measure Tvne:
Rationale
D.54. Dermatitis - Improvement in Patient-Reported Itch Severity
Cate2ory
CBE # I eCQM CBE #:
Qnalitv#:
CMSeCQMID:
Current Collection Tvne:
Current Measure Description:
Substantive Change:
Description
NIA/NIA
486
NIA
MIPS COM SPecifications
The percentage of patients aged 8 years and older, with a diagnosis of dermatitis where at an initial
(index) visit have a patient-reported itch severity assessment performed, score greater than or equal to
4, and who achieve a score reduction of 3 or more points at a follow-up visit.
Updated denominator note: Added: The initial (index) assessment and the follow-up visit for
assessment must occur during the performance period. The initial (index) visit is the first encounter
with the patient during the performance period. Every visit after the initial (index) visit during the
performance period is a follow-up visit. An assessment should be completed at each visit.
Updated numerator instructions: Removed: If a patient has multiple follow-up visits within the
measurement period, the last (most recent) visit should be used.
American Academy of Dermatology
Yes
Patient-Reported Outcome-based Performance Measure
We are proposing to update the denominator note to clarify encounter timing by including language
outlining that a patient's first visit during the measurement period is considered the initial (index)
encounter. Each visit after the initial (index) visit during the measurement period would be deemed a
follow-up visit used to determine the outcome of the measure. This change would ensure consistency
in the abstraction of the measure's elements that support rigorous data for the calculation of MIPS
performance rates.
EP31JY24.532
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Hi!!h Prioritv Measure:
Measure Tvne:
Rationale
62560
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Catee:ory
CBE # / eCOM CBE #:
Quality#:
CMSeCOMID:
Current Collection Tvne:
Current Measure Description:
Substantive Change:
D.55. Kidney Health Evaluation
Description
NIA/NIA
488
CMS951v3
eCOM Snecifications / MlPS COM Snecifications
Percentage of patients aged 18-75 years with a diagnosis of diabetes who received a kidney health
evaluation defined by an Estimated Glomerular Filtration Rate ( eGFR) AND Urine AlbuminCreatinine Ratio ( uACR) within the measurement oeriod
Updated description: For all collection types: Revised: patients aged 18-85 years.
Updated denominator: For all collection types: Revised: patients aged 18-85 years.
Updated denominator criteria: For the MIPS CQM Specifications collection type: Revised:
natients aged 18-85 vears.
National Kidney Foundation
No
Process
We are proposing to update the age from 18-75 to 18-85 years of age for denominator eligibility.
Based on information from National Institutes of Health states, "A high proportion of older CKD
patients are usually affected by multimorbidity, polypharmacy, frailty, functional and cognitive
impairment, and disability." 174 "The benefits of preventing/slowing the progression ofCKD has the
potential to impact different social and health domains, for ex.ample, reducing the need for long-term
care and the cost related to caregiving." 175 Increasing the denominator age criteria support the
reoorting of clinicians currently screening a broader elderlv nooulation for this oreventable disease.
174 Corsonello, A., Freiberger, E., & Lattanzio, F. (2020). The Screening for Chronic Kidney Disease Among Older
People across Europe (SCOPE) Project: Findings from Cross-Sectional Analysis. BMC Geriatrics, 20{Suppl 1), 316.
https://doi.org/10.1186/s12877-020-01701-w.
175 See footnote Corsonello et al., 2020.
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Hie:h Prioritv Measure:
Measure Tvne:
Rationale
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62561
D.56. Appropriate Intervention of Immune-Related Diarrhea and/or Colitis in Patients Treated with Immune Checkpoint
Inhibitors
Cate2ory
CBE # / eCQM CBE #:
Oualitv #:
CMSeCQMID:
Current Collection Tvne:
Current Measure Description:
Substantive Change:
176 FDA. (2022). FDA Approves Tremelimumab in Combination with Durvalumab and Platinum-based
Chemotherapy for Metastatic Non-small Cell Lung Cancer. https://www.fda.gov/drugs/resources-informationapproved-drugs/fda-approves-tremelimumab-combination-durvalumab-and-platinum-based-chemotherapymetastatic-non.
177 FDA. (2022). FDA Approves Opdualag for Unresectable or Metastatic Melanoma.
https://www.fda.gov/d rugs/resou rces-i nformation-approved-drugs/fda-approves-opdualag-u nresectable-ormetastatic-melanoma.
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Measure Steward:
Hil!h Prioritv Measure:
Measure Type:
Rationale
Description
N/A/N/A
490
N/A
MIPS COM Soecifications
Percentage of patients, aged 18 years and older, with a diagnosis of cancer, on immune checkpoint
inhibitor therapy, and grade 2 or above diarrhea and/or grade 2 or above colitis, who have immune
checkpoint inhibitor therapy held and corticosteroids or immunosuppressants prescribed or
administered.
Updated denominator definition: For the MIPS CQM Specifications collection type: Added:
immune checkpoint inhibitors Lag-3 inhibitor drug: Relatlimab; and Tremelimumab to CTLA-4
inbibitor drugs.
Societv for Immunotherapv of Cancer (SITC)
No
Process
We are proposing to update the denominator definition to add new Food and Drug Administration
(FDA) approved checkpoint inhibitors, Relatlimab and Tremelimumab. These inhibitors are clinically
appropriate to include in the denominator of this measure. 176 177
62562
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
D.57. Risk-Standardized Acute Cardiovascular-Related Hospital Admission Rates for Patients with Heart Failure under
the Merit-based Incentive Payment System
Category
CBE # I eCQM CBE #:
Quality#:
CMSeCQMID:
Current Collection Tvne:
Current Measure Description:
Substantive Chan2e:
Measure Steward:
High Prioritv Measure:
Measure Type:
Rationale
Description
NIA/NIA
492
NIA
Administrative Claims
Annual risk-standardized rate of acute, unplanned cardiovascular-related admissions among Medicare
Fee-for-Service (FFS) patients aged 65 years and older with heart failure (HF) or cardiomyopathv.
Updated: Reporting Requirements: Removed: individual reporting.
Centers for Medicare & Medicaid Services
Yes
Outcome
We are proposing a substantive change to this measure that would be applied retroactively starting
with the CY 2023 performance period/2025 MIPS payment year. In the CY 2023 PFS final rule, we
inadvertently specified the measure was availability at the individual clinician level. The inclusion of
the availability of the measure at the individual clinician level is a misrepresentation and erroneously
conveys to MIPS eligible clinicians reporting at the individual clinician level that the measure is
available to meet the minimum required number of measures to report under traditional MIPS or an
MVP. The measure was tested and developed for implementation at the group, virtual group,
subgroup via an MVP, and APM Entity levels. Thus, the measure is limited to groups, virtual groups,
subgroups via an MVP, and APM Entities participating in MIPS. We believe that a failure to apply
this substantive change retroactively would be contrary to the public interest.
Prior to the finalization of this measure as a new measure available within the MIPS quality measure
inventory in the CY 2023 PFS final rule, the measure was initially proposed as a new measure in the
CY 2022 PFS proposed rule. Based on the public comments received in response to the initial
proposal of this measure in the CY 2022 PFS proposed rule, there were concerns regarding the
attribution of certain patients to clinicians, particularly the risk adjustment for clinicians with higher
caseloads of patients with more complicated or severe heart failure. As a result, the measure was not
finalized as part of the CY 2022 PFS final rule; however, we noted that we would continue to
consider how to implement condition-specific measures such as this measure under MIPS (86 FR
65692 through 65694).
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In the CY 2023 PFS proposed rule, we re-proposed this measure, which mitigated the concerns
regarding the attribution of such patients to clinicians by excluding patients at advanced stages of
heart failure and requiring that a group, virtual group, subgroup via an MVP, and APM Entity to
include at least I cardiologist (and a 2I-patient case minimum); and subsequently, the measure was
finalized in the CY 2023 PFS final rule (87 FR 70266) through 70271 ). The intent of the measure is
for assessment of performance to be conducted at the group, virtual group, subgroup via an MVP, and
APM Entity levels. The measure was not tested, developed, or implemented at the individual
clinician level. In order for this measure to be available at the individual clinician level, the measure
would need to be tested at the individual clinician level to establish validity, reliability, and risk
adjustments at the individual clinician level. It is not appropriate for the measure to be available at the
individual clinician level without further testing. Consequently, any assessment of data for this
measure at the individual clinician level would produce invalid and unreliable results. By
retroactively applying the substantive change to this measure (modifying the measure to remove the
individual clinician level as an option) effective starting with the CY 2023 performance period/2025
MIPS payment year, the level of reporting available for the measure would align with the intent,
implementation, and operationalization of the measure, and clarify that the measure is not available at
the individual clinician level.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
Catee:ory
CBE # / eCQM CBE #:
Quality#:
CMSeCOMID:
Current Collection Tvne:
Current Measure Description:
Substantive Change:
62563
D.58. Adult Immunization Status
Description
3620/N/A
493
NIA
Ml PS COM Snecifications
Percentage of patients 19 years of age and older who are up-to-date on recommended routine
vaccines for influenza; tetanus and diphtheria (Td) or tetanus, diphtheria and acellular pertussis
(Tdan )· zoster and oneurnococcal.
Updated instructions: Revised: pneumococcal vaccine on or alter their 19th birthday.
Updated numerator: Revised: Submission Criteria 4: pneumococcal vaccine on or after their 19th
Measure Steward:
Hie:h Prioritv Measure:
Measure Tvne:
Rationale
birthdav.
National Committee for Quality Assurance
No
Process
We are proposing to update the measure instructions and numerator to lower the minimum age from
60 years of age to 19 years of age. This revision aligns with the updatedACIP pneumococcal
vaccination guidelines 178 that recommend administering conjugate vaccines to all adults with certain
underlying medical conditions.
178 Kobayashi, M., Pilishvili, T., Farrar, J. L., Leidner, A. J., Gierke, R., Prasad, N., Moro, P., Campos-Outcalt, D.,
Morgan, R. L., Long, S.S., Poehling, K. A., & Cohen, A. L. (2023). Pneumococcal Vaccine for Adults Aged ~19 Years:
Recommendations of the Advisory Committee on Immunization Practices, United States, 2023. MMWR.
Recommendations and Reports: Morbidity and Mortality Weekly Report. Recommendations and Reports, 72(3), 139. https://doi.org/10.15585/mmwr.rr7203al.
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In the CY 2023 PFS final rule, this measure was finalized, and it was noted that the scoring of the
measure would use a weighted average for the first 2 years of implementation; and starting with the
CY 2025 performance period/2027 MIPS payment year, the measure would be scored as an all-ornone composite measure to ensure a more thorough assessment ofa patient's vaccination status (87
FR 70272 through 70274). However, based upon an analysis of preliminary data submitted for the
CY 2023 performance period, low measure adoption, and feedback received through Quality
Payment Program Service Now tickets regarding burden of implementation and ability to meet
performance on all four components, we are proposing to maintain the weighted average analytic for
the CY 2025 performance period and subsequent years as determined by CMS. The utilization of the
weighted average metric/analytic beyond 2 years would provide clinicians with more time to prepare
for the transition to a more stringent all-or-none metric/analytic, which would require a complete
vaccination historv to meet numerator compliance.
62564
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
Catee:ory
CBE # / eCQM CBE #:
Quality#:
CMSeCOMID:
Current Collection Tvne:
Current Measure Descl"iption:
Substantive Change:
D.59. Preventive Care and Wellness (composite)
Description
NIA/NIA
497
NIA
MIPS COM Snecifications
Percentage of patients who received age- and sex-appropriate preventive screenings and wellness
services. This measure is a composite of seven component measures that are based on
recommendations for preventive care by the U.S. Preventive Services Task Force (USPSTF),
Advisory Committee on Immunization Practices (ACIP), American Association of Clinical
EndocrinoJogv (AACE). and American College of Endocrinologv (ACE).
Updated instructions: Updated: Percentage of patients 65 years of age or older who received a
pneumococcal vaccination on or after their 19th birthday.
Updated denominator exclusion: Removed: (Submission Criteria 3 and Submission Criteria 4):
specific encounter requirements from the frailty/advanced illness exclusion.
Updated denominator criteria: Added: (Submission Criteria 7) coding for nutrition/dietitian
clinician type.
Measure Steward:
Hi!!h Prioritv Measure:
Measure Tvne:
Rationale
ll pdated numerator definition: Revised: intervals for rescreening for first and second hypertensive
BP readin!!s.
Centers for Medicare & Medicaid Services
No
Process
We are proposing to update the measure instructions for patients 65 years of age and older who have
received a pneumoeoccal vaccination on or after their 19th birthday. This update would allow for the
identification of patients 65 years of age and older who may have a clinical condition that would
make them a candidate to receive the pneumococcal vaccine prior to 65 years of age. 179
We are proposing to add encounter codes for nutrition therapy to U1e denominator criteria as this is an
appropriate setting to identify people who may have elevated blood pressure (BP) readings.
Nutritional approaches play a pivotal role in helping to reduce the risk of hypertension or control
blood pressure in people with hypertension. 180
We are proposing to remove the minimum timeframe for follow-up screenings for patients with
elevated BP readings. This change allows clinician discretion to recommend a follow-up plan based
on the patient's current health status. Additionally, this supports stability of this measure component,
as the frequency is each visit, within the specification over time, while still maintaining consistency
with the current guidelines. 181
See footnote Kobayashi et al., 2023 in Table 0.58 of this Appendix.
See footnote Physicians Committee for Responsible Medicine, 2023 in Table 0.28 of this Appendix.
181 See footnote Whelton et. al., 2018 in Table 0.28 of this Appendix.
179
180
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We are proposing to update the denominator exclusion by removing the requirement for patients to
have had at least one inpatient or two outpatient encounters to recognize a diagnosis of advanced
illness. The removal of this requirement within the denominator exclusion reduces the burden of
identifying applicable encounters, while still identifying patients with an indication of frailty. This is
particularly applicable for those patients seen outside of their reporting clinician's medical record.
This revision would update the denominator exclusion to remove any patient 66 years of age and
older who has a diagnosis of advanced illness during the measurement period or the year prior from
the denominator for submission criteria 3 and submission criteria 4 of measure Q497.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62565
D.60. Connection to Community Service Provider
Cate2orv
CBE # / eCQM CBE #:
Quality#:
CMSeCQMID:
Current Collection Type:
Current Measure Description:
Substantive Change:
Ml PS CQM Specifications
Percent of patients 18 years or older who screen positive for one or more of the following health
related social needs (HRSNs): food insecurity, housing instability, transportation needs, utility help
needs, or interpersonal safety; and had contact with a Community Service Provider (CSP) for at least
l of their HRSNs within 60 days after screening.
Updated denominator criteria: Added: coding for Dentistry, Emergency Medicine, Inpatient,
Nuclear Medicine, lnterventional Radiology, Psychiatry, Mental and Behavioral Health, Nephrology,
Nutrition, Dietician, Obstetrics/Gynecology, Ophthalmology, Otolaryngology, Physical
Therapy/Occupational Therapy, Home Care and Skilled Nursing.
OCHlN
Yes
Process
We are proposing to update the denominator criteria lo include coding for multiple patient services as
this measure is applicable to the scope of care associated with these services. Clinicians treating
patients within these services have an opportunity for screening for HRSNs and connecting with an
appropriate CSP. Addressing the social determinants is an important and emerging area of practice
that entails starting earlier and broadening the scope of interventions, thus making entire families and
communities healthier. 182
Andermann, A., & CLEAR Collaboration (2016). Taking Action on the Social Determinants of Health in Clinical
Practice: A Framework for Health Professionals. CMAJ: Canadian Medical Association Journal, 188(17-18), E474E483. https://doi.org/10.1503/cmaj.160177.
182
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Measure Steward:
Hi2b Prioritv Measure:
Measure Type:
Rationale
Description
NIA/NIA
498
NIA
62566
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
D.61. Acute Posterior Vitreous Detachment Appropriate Examination and Follow-up
Category
CBE # / eCQM CBE #:
Quality#:
CMSeCQMID:
Current Collection Tvpe:
Current Measure Description:
Substantive Change:
Measure Steward:
High Prioritv Measure:
Measure Tvoe:
Rationale
Description
NIA/NIA
500
NIA
MIPS CQM Specifications
Percentage of patients with a diagnosis of acute posterior vitreous detachment (PVD) in either eye
who were appropriately evaluated during the initial exam and were re-evaluated no later than 8
weeks.
Updated denominator criteria: Added: acute PVD.
Removed: coding for non-acute disorders related to PVD.
American Societv of Retina Specialists
No
Process
We are proposing to revise the denominator criteria by removing diagnosis codes for non-acute PVD
and adding acute PVD within the criteria of the denominator. The TCD-10-CM PVD diagnosis codes
do not differentiate between acute and non-acute disorders of vitreous detachment; therefore, to
ensure the intended patient population is identified, the denominator criteria must be specific to acute
PVD.
D.62. Acute Posterior Vitreous Detachment and Acute Vitreous Hemorrhage Appropriate Examination and Follow-up
Categorv
CBE # / eCQM CBE #:
Qualitv#:
CMSeCQMID:
Current Collection Type:
Current Measure Description:
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Substantive Change:
Measure Steward:
High Prioritv Measure:
Measure Tvne:
Rationale
Descrintion
NIA/NIA
501
NIA
MIPS CQM Specifications
Percentage of patients with a diagnosis of acute posterior vitreous detachment (PVD) and acute
vitreous hemorrhage in either eye who were appropriately evaluated during the initial exam and were
re-evaluated no later than 2 weeks
Updated denominator criteria: Removed: coding for non-acute disorders related to PVD.
American Societv of Retina Specialists
No
Process
We are proposing to revise the denominator criteria by removing diagnosis codes for non-acute PVD
and adding acute PVD within the criteria of the denominator. The lCD-10-CM PVD diagnosis codes
do not differentiate between acute and non-acute disorders of vitreous detachment; therefore, to
ensure the intended patient population is identified, the denominator criteria must be specific to acute
PVD.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62567
D.63. Gains in Patient Activation Measure (PAM®) Scores at 12 Months
Cateiwrv
CBE # I eCQM CBE #:
Qualitv#:
CMSeCQMID:
Current Collection Type:
Current Measure Description:
Substantive Change:
Descrintion
2483 I NIA
503
N/A
MIPS CQM Specifications
The Patient Activation Measure® (PAM®) is a I 0- or 13- item questionnaire that assesses an
individual's knowledge, skills and confidence for managing their health and health care. The measure
assesses individuals on a 0-100 scale that converts to one of four levels of activation, from low (I) to
high (4). The PAM® performance measure (PAM®-PM) is the change in score on the PAM® from
baseline to follow-up measurement.
Updated instructions: Revised: follow-up PAM® survey collected on at least 25% of all eligible
patients within 4 to 12 months of the baseline during the performance period.
The measure denominator is revised to read:
For Submission Criteria 1: Patients aged 14 years and older with at least two qualifying visits
during the performance period.
For Submission Criteria 2, 3 & 4: Patients aged 14 years and older with Performance Met for
Submission Criteria 1 who had a baseline PAM® score and a second score within 4 to 12 month of
baseline PAM® score and who were seen for a qualifying visit at least twice during the performance
period.
Updated denominator criteria: Revised: For Submission Criteria 2, 3, & 4: follow-up PAM®
survey collected on at least 25% of all eligible patients within 4 to 12 months of the baseline during
the performance period.
Updated denominator exception: Revised: For Submission Criteria I: to remove patients with
excessive missing responses or patients who were not seen for the second PAM survey within 4
months of the baseline.
Updated denominator exclusion: Added: For ALL Submission Criteria: Patients who died during
the performance period.
Updated numerator: Revised: for ALL Submission Criteria: timing of follow-up PAM® survey to
occur 4 to 12 months after baseline.
Updated numerator definition: Added: For Submission Criteria I: clarification as to what denotes
excessive missing responses for each PAM survey.
Insignia Health, LLC, a whollv owned subsidiary of Phreesia
Yes
Patient-Reported Outcome-Based Performance Measure
We are proposing to revise multiple components of this measure to allow re-administration of the
PAM® survey no less than 4 months after the baseline survey is administered as opposed to 6
months. This change would allow a higher percentage of patients to complete the survey and be
included in the measure denominator.
Measure Steward:
Hil!:h Prioritv Measure:
Measure Tvne:
Rationale
In addition, we are proposing to lower the minimum performance threshold for collected follow-up
PAM® surveys from 50 percent to 25 percent and remove patients who were missing more than 3
responses on the PAM- IO® surveys or more than 4 responses on the PAM-13® surveys. Revising the
threshold for the collected follow-up PAM® survey reduces clinician burden by lowering the number
of survey responses that need to be collected to meet the measure denominator. We are also proposing
to add a definition to clarify what denotes excessive for missing responses. Removing patients with
excessive missing responses allows for a more complete assessment of an individual's knowledge,
skills, and confidence for managing their health and health care.
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We are also proposing to increase the number of qualifying visits to two during the performance
period and add an exclusion to remove patients who may have died during the performance period.
These revisions to the denominator ensure a patient is established within that clinician's patient
population which supports the completion of the baseline and follow-up of the survey.
62568
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
D.64. lnitiation, Review, and/or Update to Suicide Safety Plan for Individuals with Suicidal Thoughts, Behavior, or
Suicide Risk
Catee;ory
Description
CBE # / eCOM CBE #:
N/A/N/A
Qualitv#:
504
CMSeCQMID:
NIA
Current Collection Tvne:
MIPS COM Snecifications
Current Measure Description:
Percentage of adult aged 18 years and older with suicidal ideation or behavior symptoms (based on
results ofa standardized assessment tool or screening tool) or increased suicide risk (based on the
clinician's evaluation or clinician-rating tool) for whom a suicide safety plan is initiated, reviewed,
and/or undated in collaboration between the oatient and their clinician.
The measure description is revised to read: Percentage of patients aged 12 years and older with
suicidal ideation or behavior symptoms (based on results of a standardized assessment tool or
screening tool) or increased suicide risk (based on the clinician's evaluation or clinician-rating tool)
for whom a suicide safety plan is initiated, reviewed, and/or updated in collaboration between the
patient and their clinician.
Substantive Change:
The measure denominator is revised to read: For denominator submission criteria l & 2:
183 Hua, L L, Lee, J., Rahmandar, M. H., Sigel, E. J., Committee on Adolescence, & Council on Injury, Violence, and
Poison Prevention. (2024). Suicide and Suicide Risk in Adolescents. Pediatrics, 153(1), e2023064800.
https://doi.org/10.1542/peds.2023-064800.
184 See footnote Hua et al., 2024.
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Measure Steward:
Hi!!h Prioritv Measure:
Measure Tvne:
Rationale
Patients aged 12 years and older with a mental and/or substance use disorder with suicidal ideation
and/or behavior symptoms or suicide risk at a clinical encounter during the denominator
identification period.
American Psvchiatric Association
Yes
Process
We are proposing to revise the age from 18 years and older to 12 years and older for denominator
eligibility as suicide risk assessment is an important part of child and adolescent mental health. As
noted in an American Academy of Pediatrics publication. 183 "Suicide is the second leading cause of
death for 10- to 24-year-olds in the United States and is a global public health issue, with a recent
declaration ofa National State of Emergency in Children's Mental Health by the American Academy
of Pediatrics, American Academy of Child and Adolescent Psychiatry, and Children's Hospital
Association." 184
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62569
Table Group DD: Proposed Substantive Changes to Previously Finalized MIPS Quality
Measures Available Only for Use in Relevant MVPs for the CY 2025 Performance
Period/2027 MIPS Payment Year and Future Years
As finalized for the CY 2024 performance period/2026 MIPS payment year and future years, the following three MIPS quality
measures were retained for utilization in MVPs only while removed from traditional MIPS: Q 112: Breast Cancer Screening,
Q 113: Colorectal Cancer Screening, and Q 128: Preventive Care and Screening: Body Mass Index (BMI) Screening and FollowUp Plan (88 FR 79897 through 79902). We note that some MIPS quality measures available only in MVPs are adopted by the
Medicare Shared Savings Program for utilization in the Alternative Payment Model (APM) Performance Pathway (APP) and/or
APP Plus, as proposed in section XX of this proposed rule. For such measures, the collection type applicable for purposes of the
APP and/or APP Plus (Medicare CQM for Accountable Care Organizations Participating in the Medicare Shared Savings
Program (Medicare CQM)) is also specified as a collection type available for such measures described in Table Group DD.
Table Group DD within this proposed rule provides substantive changes proposed for the CY 2025 performance period/2027
MIPS payment year for MIPS quality measures available only in a relevant MVP. Two of the aforementioned MIPS quality
measures, Q 112 and Q 113, have proposed substantive changes under Table Group DD. The changes that are made to the
denominator codes sets are generalizations of the revisions communicated from the measure stewards to CMS. Additionally,
International Classification of Diseases Tenth Edition (ICD-10) and Current Procedural Terminology (CPT) codes that are
identified as invalid for CY 2025 may not be identified within this proposed rule due to the availability of these changes to the
public. If coding revisions to the denominator are impacted due to the timing of 2025 CPT and ICD-10 updates and assessment of
these codes inclusion by the Measure Steward, these changes may be postponed until CY 2026. The 2025 Quality Measure
Release Notes provide a comprehensive, detailed reference of exact codes changes to the denominators of the quality
measures. The Quality Measure Release Notes are available for each of the collection types in the Quality Payment Program
website at https:/lqpp.cms.gov.
Note: Electronic clinical quality measures (eCQMs) that are endorsed by a CBE are shown in Table DD of this Appendix as
follows: CBE # / eCQM CBE #.
In addition to the proposed substantive changes, there may be changes to the coding utilized within the denominator that are not
considered substantive in nature, but they are important to communicate to interested parties. These changes align with the scope
of the current coding; however, though not substantive in nature, these changes would expand or contract the measure's current
eligible patient population. Therefore, please refer to the current year measure specification and the 2025 Quality Measure
Release Notes or the eCQM Technical Release Notes once posted to review all coding changes to ensure correct implementation.
The eCQM Technical Release Notes should also be carefully reviewed for revisions within the logic portion of the measure. In
addition to the proposed substantive changes, there may be revisions within the logic that are not considered substantive in
nature, however, it is important to review to ensure proper implementation of the measure. As not all systems and clinical
workflows are the same, it is important to review these changes in the context of a specific system and/or clinical workflow.
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We request comments on these substantive changes.
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DD.1. Breast Cancer Screening
Cate!!orv
CBE # I eCQM CBE #:
Qualitv#:
CMSeCQMID:
Current Collection Type:
Current Measure Description:
Substantive Change:
Description
2372 / NIA
112
CMSI25vl3
Medicare Part B Claims Measure Specifications / eCQM Specifications/ MIPS CQM Specifications
Percentage of women 40 - 74 years of age who had a mammogram to screen for breast cancer in the
27 months Prior to the end of the measurement period.
Modified collection type: Medicare Part B Claims Measure Specifications, eCQM Specifications,
MIPS CQM Specifications, and Medicare CQM Specifications (collection type available only in the
APP and/or APP Plus).
Updated denominator exclusion: For all collection types: Removed: specific encounter
requirements from the frailtv/advanced illness exclusion.
National Committee for Oualitv Assurance
No
Process
We are proposing to update the denominator exclusion by removing the requirement for patients to
have had at least one inpatient or two outpatient encounters to recognize a diagnosis of advanced
illness. The removal of this requirement within the denominator exclusion reduces the burden of
identifying applicable encounters, while still identifying patients with an indication of frailty. This is
particularly applicable for those patients seen outside of their reporting clinician's medical record.
This revision would update the denominator exclusion to remove any patient 66 years of age and
older who has a diagnosis of advanced illness during the measurement period or the year prior from
the denominator of measure Q112. Decreasing complexity and burden of this element ensures
consistent imPlementation allowing for more comparable data.
Measure Steward:
Hi!!h Priority Measure:
Measure Type:
Rationale
DD.2. Colorectal Cancer Screening
Cate2ory
CBE # I eCQM CBE #:
Quality#:
CMSeCQMID:
Current Collection Tvpe:
Current Measure Description:
Substantive Change:
Updated denominator exclusion: For all collection types: Removed: specific encounter
requirements from the frailtv/advanced illness exclusion.
National Committee for Qualitv Assurance
No
Process
We are proposing to update the denominator exclusion by removing the requirement for patients to
have had at least one inpatient or two outpatient encounters to recognize a diagnosis of advanced
illness. The removal of this requirement within the denominator exclusion reduces the burden of
identifying applicable encounters, while still identifying patients with an indication of frailty. This is
particularly applicable for those patients seen outside of their reporting clinician's medical record.
This revision would update the denominator exclusion to remove any patient 66 years of age and
older who has a diagnosis of advanced illness during the measurement period or the year prior from
the denominator of measure Q113. Decreasing complexity and burden of this element ensures
consistent imolementation allowing for more comparable data.
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Hi!!h Prioritv Measure:
Measure TvPe:
Rationale
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Description
0034 / NIA
113
CMSl30vl3
Medicare Part B Claims Measure Specifications/ eCQM Specifications/ MIPS CQM Specifications
Percenta!!e of patients 45-75 vears ofa!!e who had appropriate screenin!! for colorectal cancer.
Modified collection type: Medicare Part B Claims Measure Specifications, eCQM Specifications,
MIPS CQM Specifications, and Medicare CQM Specifications (collection type available only in the
APP and/or APP Plus)
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62571
APPENDIX 2: IMPROVEMENT ACTIVITIES
In this proposed rule, for the CY 2025 performance period/2027 MIPS payment year
and future years, we are proposing to add two new improvement activities, modify two
previously adopted improvement activities, and remove eight previously adopted improvement
activities. These proposals are discussed in section IV.A.4.e.(3)(b)(iii) of this proposed rule and
in more detail below. We request comment on our proposals.
TABLE A: New Improvement Activities
for the CY 2025 Performance Period/2027 MIPS Pa ment Year and for Future Years
Proposed Activity
ID:
Proposed
Subcate o
Proposed Activity
Title:
Proposed Activity
Description:
Population Management
Implementation of Protocols and Provision of Resources to Increase Lung Cancer
Screenin U take
Establish a process or procedure to increase rates of lung cancer screening through one or
more of the following interventions:
• Implementation of protocols that support enhanced documentation methods to
identify eligible patients for lung cancer screening.
++ Example: A practice could embed electronic health record (EHR)
prompts to flag insufficient patient smoking history (for example, total
pack-years) and increase practice awareness around patient eligibility for
screening
++ Example: A practice could implement documentation processes or
procedures (for example, retrospective chart review, lung cancer screening
eligibility questionnaire) to improve patient lung cancer screening eligibility
data in the medical record
• Development of a patient outreach and activation plan consisting of educational
materials and resources for patients at high-risk of lung cancer for improved
patient engagement and decision-making.
++ Example: Providers or clinic staff could provide culturally and
linguistically appropriate patient-directed educational or care navigation
materials related to lung cancer screening, eligibility criteria for low-dose
computed tomography (LDCT), and the purpose and benefits of screening
++ Example: Providers or clinic staff could provide tools to prepare patients
for shared decision-making (SOM) clinical encounters and promote
patient/provider communication on lung cancer screening decision-making
• Establishment ofa navigation program to improve uptake and adherence oflung
cancer screening and increase rates of LDCT referral completion.
++ Example: A practice could designate and train existing clinic staff or
hire an additional staff member to counsel patients on the importance of
lung cancer screening and refer them to existing resources (for example,
transportation assistance, translator, financial services, appointment
scheduling) to support ability to obtain LDCT
++ Example: A practice could create a process to follow up with referred
patients via telephone reminders or virtual notifications (for example, email,
atient charts)
Lung cancer is a leading cause of cancer-related deaths (21 %) in the U.S., more than
colon and breast cancers combined. 1•2 While there are established guidelines for the
targeted use of LDCT for eligible patients, including particular criteria for age and
smoking history3•4, national lung cancer screening (LCS) rates are estimated at only 6.5%
as of 2020, compared to 63% for colon and 64% for breast cancer screening in 2019. 5•6
Evidence demonstrates that screening for lung cancer can improve patient outcomes. The
im lementation of rotocols that su ort enhanced documentation methods to identify
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Evidence also demonstrates the outcomes-improvement potential of the establishment of
a navigation program to improve uptake and adherence of LCS and to increase rates of
LDCT referral completion:
• In a patient navigator-led program including patient outreach to determine LCS
eligibility, SDM discussions, and appointment-scheduling with patient's PCPs,
23.5 percent ofLDCTs were performed in the intervention group compared to
8.6 percent in the control group among high-risk current smokers across 5
community health centers. 14
• An oncology nurse navigator-led provider education program resulted in
improved provider knowledge ofLDCT and documented tobacco cessation
discussions, as well as increased LDCT ordering for eligible patients. 15
• A nurse-practitioner-led LCS clinic observed a 60 percent increase in the total
number of LDCTs conducted and 85 percent of stakeholder participants noted
the clinic was effective at addressing barriers to LCS. 16
Exemplifying the importance of efforts seeking to increase LCS and follow up, guidelines
and recommendations on expanded LCS eligibility criteria and SDM
requirements by the Centers for Medicare & Medicaid Services (CMS) have recently
been implemented:
• In 2021, leading LCS clinical guideline developers, including USPSTF and the
AAFP lowered the starting age of LCS with LDCT from 55 to 50 years and
patient pack-year history from 30 to 20 years, resulting in a larger eligible
screening population. 17,3
•
In 2022, under the Medicare National Coverage Determination, CMS expanded
LCS eligibility criteria for age and pack-year history for beneficiaries receiving
LDCT in ali!mment with clinical guidelines (for examole USPSTF, AAFP).
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eligible patients for LCS has been found to increase early-stage lung cancer detection, in
one study by 24 percent (Russel et al., 2022). 7 Other studies have also shown benefits
from enhancing documentation to allow for more appropriate LCS:
• Following a retrospective chart review of existing patient smoking history and
implementation ofa notification system for primary care providers (PCPs), a
community hospital identified 82 percent of patients who were eligible for LCS
not yet referred for screening, and of that, 31 percent completed an LDCT
referral. 8
• Implementation of a clinical reminder system in an EHR to refer eligible patients
to an LCS program, increased the number of LDCTs performed from 54 percent
to 79 percent in one Veterans Affairs (VA) medical center.9
• EHR prompts generating a notification for providers to order LDCT screening
for eligible patients, increased documentation of complete patient smoking
history by 31 percent. 10
• Updating patient pack-year data in the EHR through a patient questionnaire on
smoking history and implementation of an EHR screen assessing pack-year data
in alignment with evidence-based guidelines; development of a patient outreach
and activation plan consisting of educational materials and resources for patients
at high-risk of lung cancer for improved patient engagement and decisionmaking: among patients from a tobacco quit-line utilizing a video-based LCS
decision aid, 50 percent reported feeling well-prepared to make screening
decisions than with traditional materials and 68 percent reported being clear
about their values related to the harms and benefits of screening. Additionally,
patients using the decision-aid were more knowledgeable about LCS than
participants using standard educational materials at each follow-up assessment. 11
• A web-based tool developed for SDM led to improved patient engagement,
knowledge ofLDCT, and preparation for SDM discussions among veterans in a
primary care setting. 12
• A computer tailored decision-support tool developed in alignment with the U.S.
Preventive Services Task Force (USPSTF) LCS guidelines, increased LCS
knowledge scores (2.33 mean change) and patient-perceived self-efficacy and
benefits of LCS in a community-based clinic. 13
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62573
•
In addition to the expanded eligibility criteria, CMS requires a counseling and
SDM visit to be appropriately documented in a patient's medical record and be
inclusive of determination of beneficiary eligibility and the use of one or more
decision-aids. 18
There is also published evidence that cost-effectiveness of care can improve as a result of
expanded eligibility screening. Research has found downstream effects linked to early
detection and prevention in LCS to be associated with long-term cost-effectiveness in
LCS care delivery:
• In 2021, the USPSTF expanded screening recommendations to include
individuals at an earlier age of 50 from 55 years, and minimum cumulative
smoking exposure from 30 to 20 pack-years. An economic evaluation of this
guideline change indicated that the updated recommendations were cost
effective compared to the earlier recommendations, with a mean incremental
cost-effectiveness ratio of $72,564 per quality-adjusted life-year (QALY)
gained. 19
• One study demonstrates the cost-savings of earlier diagnosis of lung cancer. In a
review of patients with non-small cell lung cancer (NSCLC), it was revealed that
the total per-patient per-month health care costs after diagnosis were
significantly higher among those diagnosed at a Stage IV and lower among
those diagnosed at Stage I ($7,239 Stage I, $9,484 Stage II, $11,193 Stage Illa,
$17,415 Stage Illb, and $21,441 Stage IV). 20
• One modeling study of costs and outcomes associated with lung cancer found
that implementation of a patient navigation program is cost-effective for lung
cancer patients in Medicare, including that the program was cost-effective at a
probability of 0.91 at $100,000/QALY. 21
•
Given the significant impact oflung cancer in the U.S.--and the effectiveness of
LCS and related interventions--as noted above, this activity has a high likelihood
.
Proposed Activity
ID:
Proposed
Subcate o
Proposed Activity
Title:
Proposed Activity
Description:
.. .
. .
...
.
IA PM XX
Population Management
Save a Million Hearts: Standardization of Approach to Screening and Treatment for
Cardiovascular Disease Risk
Implement standardized, evidence-based cardiovascular disease risk assessment and care
management for a defined population in the clinician's practice.
The clinician or clinician group will apply standardized risk assessment and care
management to a broad, clinician-defined patient population in the practice. The
population can be defined by 1) patient age and/or atherosclerotic cardiovascular disease
(ASCVD) risk factors; or 2) the constraints of the risk assessment tool (for example, the
American College of Cardiology (ACC)/American Heart Association {AHA) ASCVD
Risk Calculator is validated for patients over age 40).
The results of screening and the plan for treatment and follow up will be documented
using a standardized method in the patient's medical record. Care management plan and
follow up intervals will be influenced by the degree of patient risk.
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Cardiovascular care management should be defined by risk assessment and lead to the
development of individualized care plans with specific goals. Shared decision making
atient care lan.
should be art of the develo ment of ev
Heart disease is the leading cause of death in the United States. Stroke is the fifth most
common cause of death in the United States.22This activity is informed by the results of
the CMS Innovation Center Million Hearts Model, which included initial ASCVD
assessment as well as cardiovascular care management. 23 The Million Hearts Model used
the ACC/AHA ASCVD Risk Calculator: ASCVD Risk Estimator (acc.org). 24
62574
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
The proposed new activity supports improved identification and treatment of patients at
risk for ASCVD, and would expand on the work of the model in two ways: (l) increasing
flexibility in requirements, allowing more clinician specialties to participate, along with
increased flexibility in risk assessment to fit the needs of attesting clinicians and their
patient populations; (2) requiring the use of structured documentation of risk factors and
associated treatment plans with the aim of addressing all risk factors directly.
This activity accommodates the use of any evidence-based approach to risk evaluation
and patient care management that is implemented using standardized methods and across
an entire patient population. The ASCVD Risk Estimator used by the Million Hearts
Model is evidence based and simple to implement but may not be appropriate for every
practice scenario or patient population. There is strong published evidence validating the
ACC/AHA ASCVD Risk Calculator; describing optimal care for coronary artery disease
(including making comparisons to European Union best practices); and providing
guidelines for primary prevention of coronary artery disease. 25 ,26 ,27 ,28
1 American
Cancer Society. (2021) Can Lung Cancer Be Found Early?, https://www.cancer.org/cancer/lungcancer/detection-diagnosis-staging/detection.html.
2 NIH National Cancer Institute. Cancer Stat Facts: Lung and Bronchus Cancer. (2022).
https://seer.cancer.gov/statfacts/html/lungb.html.
3 American Academy of Family Physicians (AAFP). AAFP Updates Recommendation on Lung Cancer Screening.
(2021 ). https://www .aafp.org/news/health-of-the-public/20210406lungcancer.html.
4 National Comprehensive Cancer Network. NCCN Guidelines for Patients. (2020) Lung Cancer Screening.
https://www.nccn.org/patients/guide Iines/content/PDF /lung_ screen ing-patient.pdf.
5 Fedewa, S. A., Bandi, P., Smith, R. A., Silvestri, G. A., & Jemal, A. (2022). Lung Cancer Screening Rates During the
COVID-19 Pandemic. Chest, 161(2), 586-589. https://doi.org/10.1016/j.chest.2021.07.030.
6 National Cancer Institute (2023). Lung Cancer Screening. https://progressreport.cancer.gov/detection/lung_cancer;
accessed May 2023, last updated March 2024.
7Russel, C., McNeill, M. (2022). Improving Lung Cancer Screening Rates Through and Evidence-Based Electronic
Health Record Smoking History. Journal ofnursing care quality, 37(3), 263-268.
https://doi.org/l 0.1097/NCQ.0000000000000623.
8 Sheppard, R., Joseph, J., Achi, S., Ayinla, R. (2021). Bridging the Gap to Improve the Rate of Lung Cancer
Screening in a Minority Population: A Quality Improvement Initiative in a Community Hospital. American
College of Chest Physicians._https://doi.org/10.1016/j.chest.2021.07 .14 74.
9 Miotke, L., York, A., Bowles, A., Lewis-Williams, F., BeckJ E. (2022). Quality Initiative to Improve Lung Cancer
Screening in a Veterans Affairs Medical Center. Journal of Clinical Oncology, 40:28_suppl, 108-108.
https://doi.org/10.1200/JCO.2022.40.28.
10 Puskoor, S., Mooneyham, J., Nguyen., J, Todd, R., Germanos G., and Surapaneni, R. (2022). Improving Lung
Cancer Screening in a Community Healthcare System by Electronic Health Record (EHR) Optimization.
Journal of Clinical Oncology, 40:28_suppl, 437-437. https://doi.org/10.1200/JCO.2022.40.28.
Volk, R. J., Lowenstein, L. M., Leal, V. B., Escoto, K. H., Cantor, S. B., Munden, R. F., Rabius, V. A., Bailey, L.,
Cinciripini, P. M., Lin, H., Housten, A. J., Luckett, P. G., Esparza, A., Godoy, M. C., & Bevers, T. B. (2020).
Effect ofa Patient Decision Aid on Lung Cancer Screening Decision-Making by Persons Who Smoke: A
Randomized Clinical Trial. JAMA network open, 3(1), el 920362.
https://doi.org/10.100 l/jamanetworkopen.2019.20362.
12 Schapira, M. M., Chhatre, S., Prigge, J.M., Meline, J., Kaminstein, D., Rodriguez, K. L., Fraenkel, L., Kravetz, J.
D., Whittle, J., Bastian, L.A., Vachani, A., Akers, S., Schrand, S., Ibarra, J. V., & Asan, 0. (2022). A
Veteran-Centric Web-Based Decision Aid for Lung Cancer Screening: Usability Analysis. JMIR formative
research, 6(4), e29039. https://formative.jmir.org/2022/4/e29039.
13 Carter-Harris, L., Comer, R. S., Slaven Ii, J.E., Monahan, P. 0., Vode, E., Hanna, N. H., Ceppa, D. P., & Rawl, S.
M. (2020). Computer-Tailored Decision Support Tool for Lung Cancer Screening: Community-Based Pilot
Randomized Controlled Trial. Journal of medical Internet research, 22(11 ), e 17050.
https://pubmed.ncbi.nlm.nih.gov/33141096/.
14 Percac-Lima, S., Ashburner, J.M., Rigotti, N. A., Park, E. R., Chang, Y., Kuchukhidze, S., & Atlas, S. J. (2018).
Patient navigation for lung cancer screening among current smokers in community health centers a
randomized controlled trial. Cancer medicine, 7(3), 894-902. https://doi.org/10.1002/cam4. I297.
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J., Broome, M. E., & Schneider, S. M. (2020). Low-Dose Computed Tomography: Effects of Oncology
Nurse Navigation on Lung Cancer Screening. Clinical journal of oncology nursing, 24(4), 421-429.
https://doi.org/10.1188/20.CJON.42 l-429.
16 Schlabach, T., King, T. S., Browning, K. K., & Kue, J. (2022). Nurse practitioner-led lung cancer screening clinic:
An evidence-based quality improvement evaluation. Worldviews on evidence-based nursing, 19(3), 227-234.
https://doi.org/10.1111/wvn.12578.
17 U.S. Preventive Services Task Force (USPSTF). Final Recommendation Statement Lung Cancer: Screening. (2021).
https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/lung-cancer-screening.
18 Centers for Medicare and Medicaid Services (CMS). (2022). Screening for Lung Cancer with Low-Dose Computed
Tomography (LDCT). https://www.cms.gov/medicare-coverage-database/view/ncacaldecisionmemo.aspx?proposed=N&ncaid=304#:~:text=Beneficiary%20eligibility%20cri
teria%3A, 1%20pack%20%3D%2020%20cigarettes)%3B.
19 Toumazis, I., de Nijs, K., Cao, P., Bastani, M., Munshi, V., Ten Haaf, K., Jeon, J., Gazelle, G. S., Feuer, E. J., de
Koning, H.J., Meza, R., Kong, C. Y., Han, S.S., & Plevritis, S. K. (2021). Cost-effectiveness Evaluation of
the 2021 US Preventive Services Task Force Recommendation for Lung Cancer Screening. JAMA oncology,
7(12), 1833-1842. https://doi.org/10.1001/jamaoncol.2021.4942.
20 Gildea, T. R., DaCosta Byfield, S., Hogarth, D. K., Wilson, D.S., & Quinn, C. C. (2017). A retrospective analysis of
delays in the diagnosis oflung cancer and associated costs. ClinicoEconomics and outcomes research :
CEOR, 9, 261-269. https://doi.org/10.2147/CEOR.S132259.
21 Shih, Y. C., Chien, C.R., Moguel, R., Hernandez, M., Hajek, R. A., & Jones, L.A. (2016). Cost-Effectiveness
Analysis of a Capitated Patient Navigation Program for Medicare Beneficiaries with Lung Cancer. Health
services research, 51(2), 746-767. https://doi.org/10.l l l l/1475-6773.12333.
22 Centers for Disease Control and Prevention (n.d.). Leading Causes of Death. Retrieved from:
https://www.ems.gov/priorities/innovation/data-and-reports/202 3/mhcvdrrm-finalannevalrpt-fg. Last
reviewed January 17, 2024.
23 American College of Cardiology (n.d. ). Million Hearts Cardiovascular Disease Reduction Model (Million Hearts
Model). https://www.cms.gov/priorities/innovation/data-and-reports/2023/mhcvdrrm-finalannevalrpt-fg.
24American Co11ege of Cardiology (n.d.). ASCVD Risk Estimator:
https :I!tools. acc. org/ldl/ascvd_risk_estimator/index. html#!/calulate/estimator/.
25 Muntner, P., Colantonio, L. D., Cushman, M., Goff, D. C., Howard, G., Howard, V. J., ... & Safford, M. M. (2014).
Validation of the atherosclerotic cardiovascular disease Pooled Cohort risk equations. Jama, 311 (14 ), 14061415.
26Rodriguez-Ariza, C. D., Cabrera-Villamizar, A., Rodriguez-Pulido, A. L., Callegari, S., Ossa Rodriguez, N. A.,
Pinilla-Roncancio, M., ... & Sanchez-Vallejo, C. A. (2023). External validation of the ACC/AHA ASCVD
risk score in a Colombian population cohort. Scientific Reports, 13(1), 6139. 27Reed, S. C., Dhir, N., &
Widmer, R. J. (2022, September). Optimal cardiovascular medical therapy: current guidelines and new
developments. In Baylor University Medical Center Proceedings (Vol. 35, No. 5, pp. 636-642). Taylor &
Francis.
28 Amett, D. K., Blumenthal, R. S., Albert, M.A., Buroker, A. 8., Goldberger, Z. D., Hahn, E. J., ... & Ziaeian, 8.
(2019). 2019 ACC/AHA guideline on the primary prevention of cardiovascular disease: a report of the
American Co11ege of Cardiology/American Heart Association Task Force on Clinical Practice
Guidelines. Circulation, 140(11 ), e596-e646.
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TABLE B: Changes to Previously Adopted Improvement Activities
for the CY 2025 Performance Period/2027 MIPS Payment Year and for Future Years
In this proposed rule, we are proposing to modify two previously finalized improvement
activities for the CY 2025 performance period/2027 MIPS payment year and future years.
These proposals are discussed in section IV.A.4.e.(3)(b)(iii) of this proposed rule and in more
detail below.
Current Activity
Description:
Current Wei htin :
Proposed Activity
ID:
Proposed
Subcate or
Proposed Revised
Activi Title:
Proposed Revised
Activity Description:
Proposed Change and
Rationale:
Current Wei htin :
Proposed Activity
ID:
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Population Management
Vaccine Achievement for Practice Staff: COVID-19, Influenza, and Hepatitis B
Demonstrate that the MIPS eligible clinician's practice has achieved and/or maintained
a vaccination rate of 60 percent of clinical practice staff for COVID-19, and 80 percent
for influenza. Demonstrate vaccination, immunity, or non-responder status to hepatitis
B for 95 percent of clinical practice staff. Vaccination recommendations are from
Centers for Disease Control and Prevention; staff with contraindications to the
vaccinations, as determined by the CDC, are excluded from the requirements.
Vaccines and Immunizations CDC.
Adjusting the target goals for this activity would align with the latest CDC
recommendations and feedback received indicates that the proposal could increase the
activity's utilization. Additionally, we are expanding the focus of this activity to include
influenza and hepatitis B to highlight the importance of staff vaccination for vaccinepreventable diseases prevalent today. We are also proposing a change in this activity's
subcategory, from Emergency Response & Preparedness to Population Management, to
emphasize that staff vaccination is a long-term strategy in reducing morbidity and
mortali rates for these diseases.
lementation of im rovements in atient ortal
To receive credit for this activity, MIPS eligible clinicians must provide access to an
enhanced patient/caregiver portal that allows users (patients or caregivers and their
clinicians) to engage in bidirectional information exchange. The primary use of this
portal should be clinical and not administrative. Examples of the use of such a portal
include but are not limited to: brief patient reevaluation by messaging; communication
about test results and follow up; communication about medication adherence, side
effects, and refills; blood pressure management for a patient with hypertension; blood
sugar management for a patient with diabetes; or any relevant acute or chronic disease
mana ement.
Medium
IA BE 4
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Current Activity
Description:
COVID-19 Vaccine Achievement for Practice Staff
Demonstrate that the MIPS eligible clinician's practice has maintained or achieved a
rate of 100 percent of office staff staying up to date with COVID vaccines according to
the Centers for Disease Control and Prevention. 29 Please note that those who are
determined to have a medical contraindication specified by CDC recommendations are
excluded from this activi
Medium
IA PM XX
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Proposed
Subcategory:
Proposed Revised
Activitv Title:
Proposed Revised
Activity Description:
Proposed Change and
Rationale:
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Beneficiary Engagement
Engagement of Patients through Implementation of New Patient Portal
To receive credit for this activity, MIPS eligible clinicians must implement and provide
access to a new patient/caregiver portal that allows users (patients or caregivers and
their clinicians) to engage in bidirectional information exchange. The primary use of
this portal should be clinical and not administrative. Examples of the use of such a
portal include, but are not limited to, the following: brief patient reevaluation by
messaging; communication about test results and follow up; communication about
medication adherence, side effects, and refills; blood pressure management for a patient
with hypertension; blood sugar management for a patient with diabetes; and/or any
relevant acute or chronic disease management.
We are proposing to modify this activity's description and its validation criteria to
specify the implementation of a new patient/caregiver portal by clinicians who were not
previously using a patient portal. This activity was originally created during a time of
transition to EHRs to encourage electronic information exchange. It has become
standard practice to use patient portals; therefore, the activity is likely no longer driving
improvement among clinicians who have already implemented a patient portal. This
activity has been highly utilized year over year and continues to be in the top ten
activities reported. Limiting the activity to clinicians that implement new patient portals
in practices that previously did not use them would refocus the measure on its original
purpose and encourage clinicians who have previously implemented patient portals to
report other improvement activities that may offer meaningful opportunities for
improvement.
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29 Centers for Disease Control and Prevention (2024). Stay Up to Date with COVID-19 Vaccines. Last Updated
April 25, 2024. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/stay-up-to-date.html
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TABLE C: Improvement Activities Proposed for Removal
for the CY 2025 Performance Period/20267MIPS Payment Year and for Future Years
In this proposed rule, we are proposing to remove eight previously finalized improvement
activities beginning with the CY 2025 performance period/2027 MIPS payment year. These
proposals are discussed in section IV.A.4.e.(3)(b)(iii) of this proposed rule and in more detail
below; activity removal factors are discussed in the CY 2020 PFS final rule (84 FR 62568
through 63563).
Current Activity Title:
Current Activity
Description:
Ex anded Practice Access
Provide 24/7 Access to MIPS Eligible Clinicians or Groups Who Have Real-Time
Access to Patient's Medical Record
Provide 24/7 access to MIPS eligible clinicians, groups, or care teams for advice about
urgent care (for example, MIPS eligible clinician and care team access to medical
record, cross-coverage with access to medical record, or protocol-driven nurse line with
access to medical record) that could include one or more of the following:
• Expanded hours in evenings and weekends with access to the patient medical
record for example, coordinate with small practices to provide alternate hour office
visits and urgent care);
• Use of alternatives to increase access to care team by MIPS eligible clinicians and
groups, such as e-visits, phone visits, group visits, home visits and alternate locations
(for example, senior centers and assisted living centers); and/or
• Provision of same-day or next-day access to a MIPS eligible clinician, group or
care team when needed for ur ent care or transition mana ement.
We are proposing to remove this activity under removal factor seven, activity is
obsolete; this activity was created, in part, to incentivize utilization ofEHRs to increase
access to clinicians in off hours and decrease emergency room (ER) visits. Today,
EH Rs are highly utilized, and this activity has become standard of care. This is
supported by the fact that this activity continues to be in the top ten activities reported,
indicating that it is overutilized and that the clinical practice improvement promoted by
the activity has been achieved. We are proposing the removal of this activity in the
context of our regular review of the Inventory. In conducting this review recently, we
concluded that the goal of this activity has been widely achieved by eligible clinicians
and ractices.
Current Activity
Description:
Empanel (assign responsibility for) the total population, linking each patient to a MIPS
eligible clinician or group or care team.
Empanelment identifies the patients and population for whom the MIPS eligible
clinician or group and/or care team is responsible and is the foundation for the
relationship continuity between patient and MIPS eligible clinician or group /care team
that is at the heart of comprehensive primary care. Effective empanelment requires
identification of the "active population" of the practice: those patients who identify and
use your practice as a source for primary care. There are many ways to define "active
atients" o erationall , but enerall , the definition of"active atients" includes
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Empanelment is a series of processes that assign each active patient to a MIPS eligible
clinician or group and/or care team, confirm assignment with patients and clinicians,
and use the resultant patient panels as a foundation for individual patient and population
health management.
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Removal Rationale:
Current Activity Title:
Current Activity
Description:
Current Wei htin :
Removal Rationale:
Current Activity Title:
Current Activity
Description:
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patients who have sought care within the last 24 to 36 months, allowing inclusion of
oun er atients who have minimal acute or reventive health care.
Medium
We propose to remove this activity under removal factor seven, activity is obsolete; this
activity was designed in the early years of the MIPS program to highlight the
importance of patient population empanelment to drive patient-centered care and, over
time, to drive quality improvement. Empanelment is now more widely accepted and/or
used as an option to drive and/or measure comprehensive care, and this activity has no
requirement for implementation or improvement beyond the empanelment; therefore,
we are recommendin its removal.
Care Coordination
Implementation of use of specialist reports back to referring clinician or group to close
referral loo
Performance of regular practices that include providing specialist reports back to the
referring individual MIPS eligible clinician or group to close the referral loop or where
the referring individual MIPS eligible clinician or group initiates regular inquiries to
specialist for specialist reports which could be documented or noted in the EHR
technolo .
Medium
We propose to remove this activity under removal factor one, this activity is
duplicative, and factor five, this activity does not align with the quality, cost, or
Promoting Interoperability performance categories. This activity provides credit for
ensuring that consultation reports are communicated between an ordering and a
consulting provider, and this is now standard of care. Also, this concept is redundant
with some quality and Quality Clinical Data Registry (QCDR) measures, including
QM#374. Our recommendation for removal is supported by the fact that this activity
continues to be in the top ten activities reported, indicating that it is overutilized and
that the clinical practice improvement promoted by the activity has been achieved. We
are proposing the removal of this activity in the context of our regular review of the
Inventory. In conducting this review recently, we concluded that the goal of this activity
has been widel achieved b eli ible clinicians and ractices.
Care Coordination
Implementation of improvements that contribute to more timely communication oftest
results
Timely communication oftest results defined as timely identification of abnormal test
results with timel follow-u .
Medium
We propose to remove this activity under removal factor seven, activity is obsolete.
This activity was created, in part, to encourage strategies for timely communication and
to improve upon those strategies. This process has become widely used with the use of
EHRs and the adoption of patient portals, and is now standard of care. This is supported
by the fact that this activity continues to be in the top ten activities reported, indicating
that it is overutilized. We are proposing the removal of this activity in the context of our
regular review of the Inventory. In conducting this review recently, we concluded that
the oal of this activi has been widel achieved b eli ible clinicians and ractices.
Implement a plan to acquire, store, maintain, and replenish supplies of personal
protective equipment (PPE) for all clinicians or other staff who are in physical
proximity to patients.
In accordance with guidance from the Centers for Disease Control and Prevention
CDC the PPE Ian should address:
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Current Activity
Descri •
Curre
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Current Wei tin :
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Current Su
Current Acti
Current Activity
Description:
• Conventional capacity: PPE controls that should be implemented in general
infection prevention and control plans in healthcare settings, including training in
proper PPE use.
• Contingency capacity: actions that may be used temporarily during periods of
expected PPE shortages.
• Crisis capacity: strategies that may need to be considered during periods of known
PPE shortages.
The PPE plan should address all of the following types of PPE:
• Standard precautions (for example, hand hygiene, prevention of needle-stick or
sharps injuries, safe waste management, cleaning and disinfection of the environment)
• Eye protection
• Gowns (including coveralls or aprons)
• Gloves
• Facemasks
• Res irators includin N95 res irators
Medium
We propose to remove this activity under removal factor seven, activity is obsolete;
since the COVID-19 pandemic, most clinicians are well prepared in PPE safety, as PPE
enhancements have been made throughout patient care settings. It is unlikely that this
activity will drive new improvements. We acknowledge the ongoing importance of
PPE, and will work to ensure that, going forward, improvement activities that support
continued enhancement and maintenance of PPE rotocols are reflected in MIPS.
Develop, implement, update, and maintain a preparedness plan for a laboratory intended
to support continued or expanded patient care during COVID-19 or another public
health emergency. The plan should address how the laboratory would maintain or
expand patient access to health care services to improve beneficiary health outcomes
and reduce healthcare disparities.
For laboratories without a preparedness plan, MIPS eligible clinicians would meet with
stakeholders, record minutes, and document a preparedness plan, as needed. The
laboratory must then implement the steps identified in the plan and maintain them.
For laboratories with existing preparedness plans, MIPS eligible clinicians should
review, revise, or update the plan as necessary to meet the needs of the current PHE,
implement new procedures, and maintain the plan.
Current Activity
Descri tion:
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Behavioral and Mental Health
Electronic Health Record Enhancements for BH data ca ture
Enhancements to an electronic health record to capture additional data on behavioral
health BH o ulations and use that data for additional decision-makin u oses for
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Current Wei tin :
Removal Rationale:
Maintenance of the plan in this activity could include additional hazard assessments,
drills, training, and/or developing checklists to facilitate execution of the plan.
Participation in debriefings to evaluate the effectiveness of plans are additional
exam les of en a ement in this activi .
Medium
We propose to remove this activity under removal factor seven, activity is obsolete;
since the COVID-19 pandemic, most clinicians are now well prepared in COVID-19related patient safety and laboratory-preparedness enhancements have been made
throughout patient care settings. It is unlikely that this activity will drive new
improvements. We acknowledge the ongoing importance oflaboratory preparedness,
and will work to ensure that, going forward, improvement activities that support
continued enhancement and maintenance of lab preparedness protocols are reflected in
MIPS.
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Current Sub
Current Activi
Current Activity
Description:
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example, capture of additional BH data results in additional depression screening for atrisk atient not reviousl identified .
Medium
We propose to remove this activity under removal factor two, there is an alternative
activity with a stronger relationship to quality care or improvements in clinical practice.
This activity was created, in part, to assist in the transition from paper charts to EHRs.
While the use of EHRs is now highly prevalent and has become part of current basic
standards of care, there is still much progress to be made in terms of adoption and use
of EH Rs and other health information technologies in a behavioral health context. This
activity, though, allows attestation with a low level of effort and with vague
requirements related to clinical outcomes. Because there are other, more potentially
impactful, behavioral health activities in the current Inventory, we are recommending
that this activity be removed. IA_BMH_7, Implementation oflntegrated Patient
Centered Behavioral Health Model, which includes 'use of a registry or health
information technology functionality to support active care management and outreach
to patients in treatment,' is a strong alternative activity. We also intend, in future
rulemaking, to develop a new activity (or to modify an existing activity) to promote the
effective use of health information technolo ies in behavioral health.
For an anticoagulated patient undergoing a planned invasive procedure for which
interruption in anticoagulation is anticipated, including patients taking vitamin K
antagonists (warfarin), target specific oral anticoagulants (such as apixaban, dabigatran,
and rivaroxaban), and heparins/low molecular weight heparins, documentation,
including through the use of electronic tools, that the plan for anticoagulation
management in the periprocedural period was discussed with the patient and with the
clinician responsible for managing the patient's anticoagulation. Elements of the plan
should include the following: discontinuation, resumption, and, if applicable, bridging,
laboratory monitoring, and management of concomitant antithrombotic medications
(such as antiplatelets and nonsteroidal anti-inflammatory drugs (NSAIDs)). An invasive
or surgical procedure is defined as a procedure in which skin or mucous membranes and
connective tissue are incised, or an instrument is introduced through a natural body
orifice.
Medium
We propose to remove this activity under removal factor one, this activity is
duplicative. We recommend removal of this activity as its focus is duplicative with
IA_CC_15: PSH [Perioperative-Surgical Home] Care Coordination. lA_CC_l5
requires coordination of patient care through the perioperative period and includes
anticoagulant management as one part of its requirements. This activity, IA_PSPA_27,
is more tightly focused in an area that is high risk and, therefore, is not likely changing
clinical practice widely. We acknowledge the ongoing importance of care coordination
and medication management as a patient safety goal, and will work to ensure that, going
forward, improvement activities that support enhancement and maintenance of
medication management activities (for example, anticoagulation) are reflected in MIPS.
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APPENDIX 3: MVP INVENTORY
MVP Development: Background
In the CY 2021 PFS final rule (85 FR 84849 through 84854), the CY 2022 PFS final rule (86 FR 65998 through
66031 ), and the CY 2023 PFS final rule (87 FR 70210 through 70211) we finalized a set of criteria to use in the
development ofMVPs, including MVP reporting requirements, MVP maintenance, and the selection of measures
and activities within an MVP.
This appendix contains two groups of proposed MVP tables: Group A: proposed new MVPs and Group B: proposed
modifications to previously finalized MVPs. Group A includes six new proposed MVPs. Group B includes 16
previously finalized MVPs with proposed modifications.
Each MVP includes measures and activities from the quality performance category, improvement activities
performance category, and the cost performance category relevant to the clinical theme of the MVP. Each MVP also
includes a foundational layer comprised of population health measures and Promoting Interoperability performance
category measures.
MVP Development: Performance Category Sources
The MVP tables contain a set of MIPS quality measures, QCDR measures (as applicable), improvement activities,
cost measures, and foundational measures based on clinical topics. For further reference, the sources of the measures
and activities in the MVP tables are as follows:
• Existing MIPS quality measures are in the 2024 MIPS Quality Measures List on the Quality Payment
Program website. 1017 See Appendix I: MIPS Quality Measures of this proposed rule for any proposed additions
(Table Group A), proposed removals (Table Group B), or proposed modifications to existing quality measures
(Table Groups D and DD).
• Existing QCDR measures are based on the most recent publication of the 2024 QCDR Measure
Specification file, located on the Quality Payment Program website. 1018 We plan to modify the list of2025 QCDR
measures around December 2024.
• Improvement activities are in the 2024 Improvement Activities Inventory and the 2024 MIPS Data
Validation Criteria, located on the Quality Payment Program website. 1019 See Appendix 2: Improvement Activities
of this proposed rule for any proposed additions (Table Group A), proposed modifications to existing improvement
activities (Table Group B), or proposed removals (Table Group C).
• Existing cost measures are in the 2024 Cost Measures Inventory. 1020 See section IV.A.4.e.(2) of this
proposed rule for any proposed removals, additions, or modifications to existing cost measures.
• For further details on the population health measures (attributed to the Quality Performance Category)
included in the foundational layer, see the CY 2022 PFS final rule (86 FR 65408 through 65409).
• Existing Promoting Interoperability measures adopted in prior rulemaking and included in the
foundational layer are located on the Quality Payment Program website. 1021 There were policy updates to the
Promoting Interoperability performance category but no proposed new, modifications, or removed Promoting
Interoperability measures for the CY 2025 performance period/2027 MIPS payment year (for policy updates on this
category see section IV.A.4.e. of this proposed rule.
MVP Development: Improvement Activity Policy Update and Global Inclusion of an Improvement Activity
1017 See the 2024 MIPS Quality Measures List: https:/lqpp-cm-prodcontent.s3.amazonaws.comluploads/2632/2024%20MJPS%20Quality%20Measures%20List.xlsx.
1018 See https://qpp-cm-prod-content.s3.amazonaws.com/uploads/2617/2024%20QCDR%20Measure%20Speciflcations.xlsx for
QCDR measures.
1019 See the 2024 Improvement Activities Inventory: https:llqpp-cm-prodfor improvement activity details.
1020 See the 2024 Cost Measures Inventory: https://qpp.cms.gov/mipslexplore-measures?tab=costMeasures&py=2024.
1021 Sec the 2024 Promoting Interoperability Measure Specifications: https://qpp-cm-prodcontent.s3.amazonaws.comluploads/2223/2024%20M!PS%20Promoting%20lnteroperability%20Measure%20Speciflcations.zip
for Promoting Interoperability measure details.
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content.s3.amazonaws.com/uploads/2644/2024lmprovementActivitieslnv.zip and 2024 MIPS Data Validation Criteria:
https:l/qpp-cm-prod-content.s3.amazonaws.comluploads/2666/2024MIPSDataValidationCriteria.zip.
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We are proposing to eliminate the weighting from improvement activities and provide full credit for the
improvement activities performance category when an MVP participant attests to one improvement activity
option within the selected MVP. See section IV.A.4.e.(3)(b)(iv)ofthis proposed rule for detailed
information regarding the proposed removal of weighting from improvement activities and for detailed
information regarding our proposed reporting requirement changes for improvement activities.
We are proposing to modify IA_ERP_6: COVID-19 Vaccine Achievement for Practice Staff to expand the
focus and importance of vaccination status to drive improvement across the practice. We are proposing to add
the proposed modified IA_ERP_6 to all new and previously fmalized MVPs because of the importance of
vaccination status in practice settings. See Appendix 2, Improvement Activities: Table B of this proposed rule
for detailed information regarding the proposed modifications to TA_ERP_6: COVTD-19 Vaccine
Achievement for Practice Staff, including a proposed activity ID and title update.
MVP Table Symbol Information and Definitions
Please note the following symbols and definitions used within the MVP tables in the Group A and Group B tables
below:
• Quality measures, improvement activities, and cost measures proposed for addition to a previously
finalized MVP are identified with a plus sign(+) within the Group B MVP tables in this appendix.
• New quality measures, improvement activities, and cost measures proposed for inclusion in MIPS
beginning with the CY 2025 performance period/2027 MIPS payment year and future years are identified with a
caret symbol("). See Appendix 1, MIPS Quality Measures: Table Group A of this proposed rule for further
information regarding new MIPS quality measures. See Appendix 2: Improvement Activities: Table A of this
proposed rule for further information regarding new improvement activities. See section IV.A.4.e.(2)(a)(iii)ofthis
proposed rule for further information regarding new cost measures.
• Existing measures and improvement activities with proposed revisions are identified with a single
asterisk(*). See Appendix 1, MIPS Quality Measures: Table Group D of this proposed rule for further information
regarding proposed revisions to MIPS quality measures. See Appendix 2: Improvement Activities: Table B of this
proposed rule for further information regarding proposed revisions to improvement activities. See section
IV.A.4.e.(2)(a)(vi) and IV.A.4.e.(2)(a)(vii)ofthis proposed rule for further information regarding proposed revisions
to cost measures. We intend to include existing measures or activities with proposed revisions in MVPs (as
applicable) regardless of whether the proposed revisions are fmalized beginning with the CY 2025 performance
period/2027 MIPS payment year.
• Quality measures and improvement activities identified with a double asterisk(**) can only be submitted
when included in an MVP.
• Quality measures considered high priority (as defmed in§ 414.1305) are identified with a single
exclamation point(!) while outcome measures (as defined in § 414. 1305) are identified with a double exclamation
point(!!). Further details of these types of measures are in the CMS Measures Management System Hub. 1022
• QCDR measures identified with a pound sign(#) indicate testing data is still pending and due on or
before September 1, 2024. We refer readers to the CY 2022 PFS final rule for additional details regarding
requirements for QCDR measures considered for an MVP (86 FR 65407 through 65408).
• Quality measures and improvement activities that include a health equity component are identified with a
tilde(-) within the MVP table.
• IA PCMH: Electronic submission of Patient Centered Medical Home accreditation is identified with a
percent(%) to indicate attestation to this improvement activity provides full credit for the improvement activity
performance category within an MVP.
• Quality measure collection types are identified in parentheses after each quality measure title, and
improvement activity medium/high weight designations are identified in parentheses after each improvement
activity
Group A: New MVPs Proposed for the CY 2025 Performance Period/2027 MIPS Payment
Year and Future Years
The proposed Complete Ophthalmologic Care MVP assesses meaningful outcomes in cataract, glaucoma, retinal detachment, and
broadly applicable ocular care. This MVP would be most applicable to clinicians who treat patients within the practice of
ophthalmology and optometry.
1022
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A.1 Complete Ophthalmologic Care MVP
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Quality Measures
The following quality measures provide a meaningful and comprehensive assessment of the clinical care for clinicians who
specialize in ocular care:
0012: Primary Open-Angle Glaucoma (POAG): Optic Nerve Evaluation: This MIPS quality measure evaluates
•
changes in the optic nerve which define the progression and worsening of glaucoma disease status.
•
0019: Diabetic Retinopathy: Communication with the Physician Managing Ongoing Diabetes Care: This MIPS quality
measure focuses on the communication between the primary physician managing ongoing care and the physician
performing the dilated macular or fundus exam on patients with diabetic retinopathy.
•
0117: Diabetes: Eye Exam: This MIPS quality measure supports eye screening for diabetic retinal disease.
•
0141: Primary Open-Angle Glaucoma (POAG): Reduction ofintraocular Pressure 2014
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We are proposing to include 18 MIPS quality measures and 6 QCDR measures within the quality performance category of this
MVP, which are specific to the clinical topic of ocular care by assessing ocular health and treatment of disorders attributed to
diabetes related disease, glaucoma, retinal detachment, and cataracts. We reviewed the MIPS quality measure inventory and
considered feedback received during the 2025 MVP candidate feedback period to determine which quality measures best
represent the clinical topic of this MVP.
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0130: Documentation of Current Medications in the Medical Record: This MIPS quality measure bases performance
on clinicians documenting the list of current medications using all immediate resources for capture of this important
clinical topic.
0226: Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention: This MIPS quality measure
ensures patients are screened for tobacco use and if screened positive receive tobacco cessation intervention.
0374: Closing the Referral Loop: Receipt of Specialist Report: This MIPS quality measure is attributable to the
clinician referring the patient and ensures report receival from the referred to clinician, closing the communication
loop.
0487: Screening for Social Drivers of Health: This MIPS quality measure ensures adults are screened for food
insecurity, housing instability, transportation needs, utility difficulties, and interpersonal safety.
0503: Gains in Patient Activation Measure (PAM®) Scores at 12 Months: This MIPS quality measure ensures capture
of the patient voice and experience of care related to the patient's understanding and confidence in the clinician's
ability to manage their health and be an active partner in the health care journey.
Improvement Activities
We reviewed the Improvement Activities Inventory and considered feedback received during the 2025 MVP candidate feedback
period to determine the set of improvement activities to include in this MVP. We are proposing to include 14 improvement
activities that reflect actions and processes undertaken by clinicians who specialize in ocular care, as well as activities that
promote patient engagement and patient-centeredness, health equity, shared decision making, and care coordination. These
improvement activities provide opportunities for clinicians, in collaboration with patients, to drive outcomes and improve quality
of care. The following improvement activities are proposed for inclusion in this MVP:
•
IA_AHE_I: Enhance Engagement of Medicaid and Other Underserved Populations
•
IA_AHE_9: lmplement Food Insecurity and Nutrition Risk Identification and Treatment Protocols
•
IA_BE_4: Engagement of patients through implementation of improvements in patient portal
•
IA_BE_6: Regularly Assess Patient Experience of Care and Follow Up on Findings
•
IA_BE_25: Drug Cost Transparency
•
IA_CC_9: Implementation of practices/processes for developing regular individual care plans
•
IA_CC_l0: Care transition documentation practice improvements
•
IA_CC_13: Practice improvements to align with OpenNotes principles
•
IA ERP 6: COVID-19 Vaccine Achievement for Practice Staff
•
IA_MVP: Practice-Wide Quality Improvement in MIPS Value Pathways
•
IA PCMH: Electronic submission of Patient Centered Medical Home accreditation
•
IA_PM_ 13: Chronic care and preventative care management for empaneled patients
•
IA_PM_l6: Implementation of medication management practice improvements
•
IA_PSPA_7: Use ofQCDR data for ongoing practice assessment and improvements
We are proposing to modify the IA_BE_4: Engagement of patients through implementation of improvements in patient portal
improvement activity, which includes a proposed activity title update. Please see Appendix 2, Improvement Activities: Table
Group B of this proposed rule for all proposed revisions to this activity.
Cost Measures
We are proposing to include one MIPS cost measure within the cost performance category of this MVP, which applies to the
clinical topic of ocular care. We reviewed the MIPS cost measure inventory and considered feedback received during the 2025
MVP candidate feedback period to determine the set of cost measures to include in this MVP. The following cost measure
provides a meaningful assessment of the clinical care for clinicians who specialize in ocular care, specifically cataract removal,
and aligns with other measures and activities within this MVP:
•
Routine Cataract Removal with Intraocular Lens (IOL) Implantation: This MIPS episode-based cost measure assesses
costs associated with routine cataract removal. The addition of this measure aligns with included quality measures, such
as Ql91: Cataracts: 20/40 or Better Visual Acuity within 90 Days Following Cataract Surgery and Q303: Cataracts:
Improvement in Patient's Visual Function within 90 Days Following Cataract Surgery.
We are proposing to modify the Routine Cataract Removal with Intraocular Lens (IOL) Implantation cost measure, which
includes a proposed measure title update. Please see section IV.A.4.e(2)(a)(vi) of this proposed rule for all proposed revisions to
this measure.
As stated in the introduction of this appendix, we considered measures and improvement activities available within the MIPS
inventory and selected those we determined best fit the clinical concept of the proposed Complete Ophthalmologic Care MVP.
We request comment on the measures and activities included in this MVP.
Symbol Key:
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62586
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
Single asterisk(*): existing measures and improvement activities with proposed revisions
Double asterisk(**): measures and improvement activities only available when included in an MVP
Single exclamation point(!): high priority measures
Double exclamation point(!!): outcome measures
Tilde(-): measures and improvement activities that include a health equity component
Percent(%): attestation to IA_PCMH: Electronic submission of Patient Centered Medical Home accreditation provides full credit
for the improvement activity performance category
Pound sign(#): QCDR measures pending testing data
Q012: Primary Open-Angle Glaucoma
(POAG): Optic Nerve Evaluation
(Collection Type: eCQM Specifications)
(~) IA_AHE_l: Enhance Engagement of
Medicaid and Other Underserved Populations
(High)
(*)(!) Q019: Diabetic Retinopathy:
Communication with the Physician Managing
Ongoing Diabetes Care
(Collection Type: eCQM Specifications,
MIPS CQMs Specifications)
(~) IA~AHE_9: Implement Food Insecurity
and Nutrition Risk Identification and
Treatment Protocols
(Medium)
(*) Q117: Diabetes: Eye Exam
(Collection Type: eCQM Specifications,
MIPS CQMs Specifications)
(*) IA_BE_4: Engagement of patients
through implementation of improvements in
patient portal
(Medium)
(*)(!) Q130: Documentation of Current
Medications in the Medical Record
(Collection Type: eCQM Specifications,
MIPS CQMs Specifications)
IA_BE_6: Regularly Assess Patient
Experience of Care and Follow Up on
Findings
(High)
(!!) Ql41: Primary Open-Angle Glaucoma
(POAG): Reduction of Intraocular Pressure
(TOP) by 20% OR Documentation of a Plan of
Care
(Collection Type: Medicare Part B Claims
Specifications, MIPS CQMs Specifications)
IA_BE_25: Drug Cost Transparency
(High)
(!!) Q191: Cataracts: 20/40 or Better Visual
Acuity within 90 Days Following Cataract
Surgery
(Collection Type: eCQM Specifications,
MIPS CQMs Specifications)
Q226: Preventive Care and Screening:
Tobacco Use: Screening and Cessation
Intervention
(Collection Type: Medicare Part B Claims,
eCQM Specifications, MIPS CQMs
Specifications)
(!!) Q303: Cataracts: Improvement in
Patient's Visual Function within 90 Days
Following Cataract Surgery
(Collection Type: MIPS CQMs
Specifications)
(!) Q304: Cataracts: Patient Satisfaction
within 90 Days Following Cataract Surgery
(Collection Type: MIPS CQMs
Specifications)
(~) IA_CC_9: Implementation of
practices/processes for developing regular
individual care plans
(Medium)
H IA_CC_l0: Care transition
documentation practice improvements
(Medium)
IA_CC_13: Practice improvements to align
with OpenNotes principles
(Medium)
(*) 1A_ERP_6: COVTD-19 Vaccine
Achievement for Practice Staff
(Medium)
(**) IA_MVP: Practice-Wide Quality
Improvement in MIPS Value Pathways
(High)
(%) JA_PCMH: Electronic submission of
Patient Centered Medical Home accreditation
IA_PM_ 13: Chronic care and preventative
care management for empaneled patients
(Medium)
IA_PM_l6: Implementation of medication
management practice improvements
(Medium)
(~) IA_PSPA_7: Use ofQCDR data for
(*)(!!) Q384: Adult Primary Rhegmatogenous ongoing practice assessment and
Retinal Detachment Surgery: No Return to
improvements
the Operating Room Within 90 Days of
(Medium)
Surgery
(Collection Type: MIPS CQMs
Specifications)
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(*)(!) Q374: Closing the Referral Loop:
Receipt of Specialist Report
(Collection Type: eCQM Specifications,
MIPS CQMs Specifications)
(*) Routine Cataract Removal with
lntraocular Lens (IOL) Implantation
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62587
(!!) Q385: Adult Primary Rhegmatogenous
Retinal Detachment Surgery: Visual Acuity
Improvement Within 90 Days of Surgery
(Collection Type: MIPS CQMs
Specifications)
(!!) Q389: Cataract Surgery: Difference
Between Planned and Final Refraction
(Collection Type: MIPS CQMs
Specifications)
(~)(!) Q487: Screening for Social Drivers of
Health
(Collection Type: MIPS CQMs
Specifications)
Q499: Appropriate Screening and Plan of
Care for Elevated lntraocular Pressure
Following lntravitreal or Periocular Steroid
Therapy
(Collection Type: MIPS CQMs
Specifications)
(*) QS00: Acute Posterior Vitreous
Detachment Appropriate Examination and
Follow-up
(Collection Type: MIPS CQMs
Specifications)
(*) Q501: Acute Posterior Vitreous
Detachment and Acute Vitreous Hemorrhage
Appropriate Examination and Follow-up
(Collection Type: MIPS CQMs
Specifications)
(*)(!!) Q503: Gains in Patient Activation
Measure (PAM®) Scores at 12 Months
(Collection Type: MIPS CQMs
Specifications)
(!!)(#) IRIS2: Glaucoma- lntraocular
Pressure Reduction
(Collection Type: QCDR)
(!!)(#) IRIS13: Diabetic Macular EdemaLoss of Visual Acuity
(Collection Type: QCDR)
(!!)(#) IRIS39: Intraocular Pressure
Reduction Following Trabeculectomy or an
Aqueous Shunt Procedure
(Collection Type: QCDR)
(!!)(#) IRIS54: Complications after Cataract
Surgery
(Collection Type: QCDR)
(!!)(#) IRIS61: Visual Acuity Improvement
Following Cataract Surgery and Minimally
Invasive Glaucoma Surgery
Collection T
: CDR
TABLE A.lb: Complete Ophthalmologic Care MVP Foundational Layer
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(!!)(#) IRIS58: Improved Visual Acuity after
Vitrectomy for Complications of Diabetic
Retinopathy within 120 Days
(Collection Type: QCDR)
62588
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
(!!) Q479: Hospital-Wide, 30-Day, All-Cause Unplanned
Readmission (HWR) Rate for the Merit-Based Incentive Payment
Systems (MIPS) Groups
(Collection Type: Administrative Claims)
(!!) Q484: Clinician and Clinician Group Risk-standardized Hospital
Admission Rates for Patients with Multiple Chronic Conditions
(Collection Type: Administrative Claims)
Security Risk Analysis
High Priority Practices Safety Assurance Factors for EHR Resilience
Guide (SAFER Guide)
e-Prescribing
Query of Prescription Drug Monitoring Program (POMP)
Provide Patients Electronic Access to Their Health Information
Support Electronic Referral Loops By Sending Health Information
AND
Support Electronic Referral Loops By Receiving and Reconciling
Health Information
OR
Health Information Exchange (HIE) Bi-Directional Exchange
OR
Enabling Exchange Under the Trusted Exchange Framework and
Common Agreement (TEFCA)
Immunization Registry Reporting
Syndromic Surveillance Reporting (Optional)
Electronic Case Reporting
Public Health Registry Reporting (Optional)
Clinical Data Registry Reporting (Optional)
Actions to Limit or Restrict Compatibility or Interoperability of
CEHRT
ONC Direct Review Attestation
A.2 Dermatological Care MVP
The proposed Dermatological Care MVP focuses on the clinical theme of providing treatment and management of dermatologic
care. This MVP would be most applicable to clinicians who treat patients within the practice of dermatology, including
nonphysician practitioners (NPPs) such as nurse practitioners and physician assistants.
Quality Measures
The following quality measures provide a meaningful and comprehensive assessment of the clinical care for clinicians who
specialize in dermatology:
0176: Tuberculosis Screening Prior to First Course of Biologic and/or Immune Response Modifier Therapy: This
•
MIPS quality measure ensures TB testing is completed prior to the first course of biologic and/or immune response
modifier therapy.
0397: Melanoma Reporting: This MIPS quality measure assesses that the pathology report for primary malignant
•
cutaneous melanoma includes reporting identifiers needed for microsatellitosis of invasive tumors.
•
0410: Psoriasis: Clinical Response to Svstemic Medications: This MIPS quality measure ensures patients with
psoriasis vulgaris who are being treated with systemic medications maintain disease control by evaluating documented
body surface assessments meet at least one of the specified benchmarks.
•
0440: Skin Cancer: Biopsy Reporting Time - Pathologist to Clinician: This MIPS quality measure ensures pathology
reports diagnosing carcinoma or melanoma are communicated from the Pathologist/Dermatopathologist within 7 days
from the Pathologist receiving the specimen.
•
0485: Psoriasis - Improvement in Patient-Reported Itch Severity: This MIPS quality measure evaluates patients with a
diagnosis of psoriasis for a reduction in itch severity of 3 or more points at follow up visits.
•
0486: Dermatitis - Improvement in Patient-Reported Itch Severity: This MIPS quality measure evaluates patients with
a diagnosis of dermatitis for a reduction in itch severity of 3 or more points at follow up visits.
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We are proposing to include 11 MIPS quality measures and 6 QCDR measure within the quality performance category of this
MVP, which are specific to the clinical topic of dermatology. We reviewed the MIPS quality measure inventory and considered
feedback received during the 2025 MVP candidate feedback period to determine which quality measures best represent the
clinical topic of this MVP.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
•
•
•
•
•
•
•
62589
TBD: Melanoma: Tracking and Evaluation of Recurrence: This proposed MIPS quality measure ensures patients who
undergo excisional surgery for melanoma or melanoma in situ within the previous 5 years have documentation that an
exam for recurrence of melanoma was performed within the performance period and results captured.
AAD6: Skin Cancer Biopsy Reporting Time - Clinician to Patient: This QCDR measure ensures timely communication
from the clinician to the patient when they have a positive finding for carcinoma, melanoma, or primary cutaneous
malignancies.
AAD8: Chronic Skin Conditions: Patient Reported Quality-of-Life: This QCDR measure ensures a patient- reported
quality-of-life assessment is completed and recorded in the medical record with a plan of care at least once in the
performance period.
AAD 12: Melanoma: Appropriate Surgical Margins: This QCDR measure ensures the initial biopsy and surgical
margins are documented in the medical record and are in compliance with the minimum margin recommended in the
current National Comprehensive Cancer Network (NCCN) guideline.
AAD16: Avoidance of Post-operative Systemic Antibiotics for Office-based Closures and Reconstruction After Skin:
This QCDR measure assesses for the appropriate use of post operative antibiotics for patients with skin cancer
undergoing an office-based closure or reconstruction procedure.
AAD17: Continuation of Anticoagulation Therapy in the Office-based Setting for Closure and Reconstruction After
Skin Cancer Resection Procedures: This QCDR measure assesses the percentage of patients who had their
anticoagulation therapy continued prior to an in-office procedure for intermediate layer and/or complex linear closures
OR reconstruction after skin cancer resection performed.
AAD18: Avoidance of Opioid Prescriptions for Closure and Reconstruction After Skin Cancer Resection: This QCDR
measure identifies the number of patients diagnosed with skin cancer who were prescribed an opioid/narcotic therapy
as a first line pain management option post-operative by the reconstructing surgeon.
The following broadly applicable MIPS quality measures are relevant to clinicians who specialize in dermatology. The quality
measures below assess for age-specific screenings, and follow-up actions for select measures:
0130: Documentation of Current Medications in the Medical Record: This MIPS quality measure bases performance
•
on clinicians documenting the list of current medications using all immediate resources for capture of this important
clinical topic.
0226: Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention: This MIPS quality measure
•
ensures patients are screened for tobacco use and if screened positive receive tobacco cessation intervention.
0487: Screening for Social Drivers of Health: This MIPS quality measure ensures adults are screened for food
•
insecurity, housing instability, transportation needs, utility difficulties, and interpersonal safety.
0503: Gains in Patient Activation Measure (PAM®) Scores at 12 Months: This MIPS quality measure ensures capture
•
of the patient voice and experience of care related to the patient's understanding and confidence in the clinician's
ability to manage their health and be an active partner in the health care journey.
Improvement Activities
We reviewed the Improvement Activities Inventory and considered feedback received during the 2025 MVP candidate feedback
period to determine the set of improvement activities to include in this MVP. We are proposing to include 11 improvement
activities that reflect actions and processes undertaken by clinicians who specialize in dermatology, as well as activities that
promote patient engagement and patient-centeredness, health equity, shared decision making, and care coordination. These
improvement activities provide opportunities for clinicians, in collaboration with patients, to drive outcomes and improve quality
of care. The following improvement activities are proposed for inclusion in this MVP:
•
IA_AHE_I: Enhance Engagement of Medicaid and Other Underserved Populations
•
IA_AHE_6: Provide Education Opportunities for New Clinicians
•
IA_BE_4: Engagement of patients through implementation of improvements in patient portal
•
IA_BE_6: Regularly Assess Patient Experience of Care and Follow Up on Findings
•
IA_BE_ 15: Engagement of patients, family and caregivers in developing a plan of care
•
IA_EPA_2: Use oftelehealth services that expand practice access
•
IA_ERP_6: COVJD-19 Vaccine Achievement for Practice Staff
•
IA_MVP: Practice-Wide Quality Improvement in MIPS Value Pathways
•
IA_PCMH: Electronic submission of Patient Centered Medical Home accreditation
•
IA_PM_16: Implementation of medication management practice improvements
IA_PSPA_ 8: Use of Patient Safety Tools
•
We are proposing to modify the IA_BE_4: Engagement of patients through implementation of improvements in patient portal
improvement activity, which includes a proposed activity title update. Please see Appendix 2, Improvement Activities: Table
Group B of this proposed rule for all proposed revisions to this activity.
We are proposing to include one MIPS cost measure within the cost performance category ofthis MVP, which applies to the
clinical topic of dermatology. We reviewed the MIPS cost measure inventory and considered feedback received during the 2025
MVP candidate feedback period to determine the set of cost measures to include in this MVP. The following cost measure
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Cost Measures
62590
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
provides a meaningful assessment of the clinical care for clinicians who specialize in dermatology, specifically melanoma
resection, and aligns with other measures and activities within this MVP:
•
Melanoma Resection: This MIPS episode-based cost measure assesses costs associated with excision procedures to
remove a cutaneous melanoma. The addition of this measure aligns with Q397: Melanoma Reporting and TBD:
Melanoma: Tracking and Evaluation of Recurrence.
Dermatological Care MVP Tables
As stated in the introduction of this appendix, we considered measures and improvement activities available within the MIPS
inventory and selected those we determined best fit the clinical concept of the proposed Dermatological Care MVP. We request
comment on the measures and activities included in this MVP.
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Symbol Key:
Carat symbol("): new proposed measures and improvement activities
Single asterisk (*): existing measures and improvement activities with proposed revisions
Double asterisk(**): measures and improvement activities only available when included in an MVP
Single exclamation point(!): high priority measures
Double exclamation point ( !!): outcome measures
Tilde(-): measures and improvement activities that include a health equity component
Percent(%): attestation to IA_PCMH: Electronic submission of Patient Centered Medical Home accreditation provides full credit
for the improvement activity performance category
Pound sign(#): QCDR measures pending testing data
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
(*)(!) QlJO: Documentation of Current
Medications in the Medical Record
(Collection Type: eCQM Specifications,
MIPS CQMs Specifications)
(*) Ql 76: Tuberculosis Screening Prior to
First Course of Biologic and/or Immune
Response Modifier Therapy
(Collection Type: MlPS CQMs
Specifications)
Q226: Preventive Care and Screening:
Tobacco Use: Screening and Cessation
Intervention
(Collection Type: Medicare Part B Claims
Specifications, eCQM Specifications, MIPS
CQMs Specifications)
(~) IA_AHE_l: Enhance Engagement of
Medicaid and Other Underserved Populations
(High)
(*) IA_BE_4: Engagementofpatients
through implementation of improvements in
patient portal
(Medium)
IA_BE_6: Regularly Assess Patient
Experience of Care and Follow Up on
Findings
(High)
IA_BE_15: Engagement of patients, family
and caregivers in developing a plan of care
(Medium)
(!!) Q410: Psoriasis: Clinical Response to
Systemic Medications
(Collection Type: MIPS CQMs
Specifications)
IA_EPA_2: Use oftelehealth services that
expand practice access
(Medium)
(*)(!!) Q485: Psoriasis - Improvement in
Patient-Reported Itch Severity
(Collection Type: MIPS CQMs
Specifications)
(*)(!!) Q486: Dermatitis - Improvement in
Patient-Reported Itch Severity
(Collection Type: MIPS CQMs
Specifications)
(~)(!) Q487: Screening for Social Drivers of
Health
(Collection Type: MIPS CQMs
Specifications)
Melanoma Resection
(-) IA_AHE_6: Provide Education
Opportunities for New Clinicians
(High)
(!) Q397: Melanoma Reporting
(Collection Type: Medicare Part B Claims,
MIPS CQMs Specifications)
(!) Q440: Skin Cancer: Biopsy Reporting
Time - Pathologist to Clinician
(Collection Type: MIPS CQMs
Specifications)
62591
(*) IA_ERP_6: COVID-19 Vaccine
Achievement for Practice Staff
(Medium)
(**) IA_MVP: Practice-Wide Quality
Improvement in MIPS Value Pathways
(High)
(%) IA_PCMH: Electronic submission of
Patient Centered Medical Home accreditation
IA_PM_16: Implementation of medication
management practice improvements
(Medium)
IA_PSPA_8: Use of Patient Safety Tools
(Medium)
(*)(!!) Q503: Gains in Patient Activation
Mea~ure (PAM®) Scores at 12 Months
(Collection Type: MIPS CQMs
Specifications)
(A)(!) TBD: Melanoma: Tracking and
Evaluation of Recurrence
(Collection Type: MIPS CQMs
Specifications)
(!)(#) AAD6: Skin Cancer Biopsy Reporting
Time - Clinician to Patient
(Collection Type: QCDR)
(!!)(#) AAD12: Melanoma: Appropriate
Surgical Margins
(Collection Type: QCDR)
(!)(#) AAD16: Avoidance of Post-operative
Systemic Antibiotics for Office-based
Closures and Reconstruction After Skin
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(!) AAD8: Chronic Skin Conditions: Patient
Reported Quality-of-Life
(Collection Type: QCDR)
62592
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
Cancer Procedures
(Collection Type: QCDR)
(!)(#) AAD17: Continuation of
Anticoagulation Therapy in the Office-based
Setting for Closure and Reconstruction After
Skin Cancer Resection Procedures
(Collection Type: QCDR)
(!)(#) AAD18: Avoidance of Opioid
Prescriptions for Closure and Reconstruction
After Skin Cancer Resection
Collection T e: QCDR)
(!!) Q479: Hospital-Wide, 30-Day, All-Cause Unplanned
Readmission (HWR) Rate for the Merit-Based Incentive Payment
Systems (MIPS) Groups
(Collection Type: Administrative Claims)
(!!) Q484: Clinician and Clinician Group Risk-standardized Hospital
Admission Rates for Patients with Multiple Chronic Conditions
(Collection Type: Administrative Claims)
Security Risk Analysis
High Priority Practices Safety Assurance Factors for EHR Resilience
Guide (SAFER Guide)
e-Prescribing
Query of Prescription Drug Monitoring Program (PDMP)
Provide Patients Electronic Access to Their Health Information
Support Electronic Referral Loops By Sending Health Information
AND
Support Electronic Referral Loops By Receiving and Reconciling
Health Information
OR
Health Information Exchange (HIE) Bi-Directional Exchange
OR
Enabling Exchange Under the Trusted Exchange Framework and
Common Agreement (TEFCA)
Immunization Registry Reporting
Syndromic Surveillance Reporting (Optional)
Electronic Case Reporting
Public Health Registry Reporting (Optional)
Clinical Data Registry Reporting (Optional)
Actions to Limit or Restrict Compatibility or Interoperability of
CEHRT
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Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62593
A.3 Gastroenterology Care MVP
The proposed Gastroenterology Care MVP focuses on the clinical theme of providing treatment and management of the digestive
system and the liver. This MVP would be most applicable to clinicians who treat patients within the practice of gastroenterology,
including nonphysician practitioners (NPPs) such as nurse practitioners and physician assistants.
Quality Measures
We are proposing to include 11 MIPS quality measures and 3 QCDR measures within the quality performance category of this
MVP, which are specific to the clinical topic of gastroenterology. We reviewed the MIPS quality measure inventory and
considered feedback received during the 2025 MVP candidate feedback period to determine which quality measures best
represent the clinical topic of this MVP.
The following quality measures provide a meaningful and comprehensive assessment of the clinical care for clinicians who
specialize in gastroenterology:
•
0113: Colorectal Cancer Screening: This MIPS quality measure ensures appropriate screening of patients for colorectal
cancer.
•
0185: Colonoscopy Interval for Patients with a History of Adenomatous Polyps - Avoidance oflnaooropriate Use:
This MIPS quality measure ensures appropriate follow-up, an interval of 3 or more years, for patients with a history of
prior adenomatous polyp(s) in previous colonoscopy.
0275: Inflammatory Bowel Disease (IBD): Assessment of Hepatitis B Virus /HBV) Status Before Initiating Anti-TNF
•
(Tumor Necrosis Factor) Therapy: This MIPS quality measure requires patients with a diagnosis of inflammatory
bowel disease (IBD) have Hepatitis B Virus (HBV) status assessed prior to initiating anti-TNF (tumor necrosis factor)
therapy.
0320: Appropriate Follow-Up Interval for Normal Colonoscopy in Average Risk Patients: This MIPS quality measure
•
ensures appropriate follow-up for patients receiving a screening colonoscopy without biopsy or polypectomy.
•
0400: One-Time Screening for Hepatitis C Virus (HCV) and Treatment Initiation: This MIPS quality measure requires
patients have received a one-time screening for hepatitis C virus (HCV) infection as well as treatment initiation or
referral if screening is positive.
•
0401: Hepatitis C: Screening for Hepatocellular Carcinoma (HCC) in Patients with Cirrhosis: This MIPS quality
measure ensures patients with a diagnosis of chronic Hepatitis C cirrhosis have appropriate surveillance imaging for
hepatocellular carcinoma at least once during the performance period.
•
GIOIC23: Appropriate follow-up interval based on pathology findings in screening colonoscopy: This QCDR measure
ensures appropriate follow-up consistent with US Multi-Society Task Force (USMSTF) recommendations based upon
pathology findings from screening colonoscopy with biopsy or polypectomy documented in colonoscopy report.
•
GIOIC26: Screening Colonoscopy Adenoma Detection Rate: This QCDR measure evaluates patients who had a
screening colonoscopy and at least one conventional adenoma or colorectal cancer was detected.
•
NHCR4: Repeat screening or surveillance colonoscopy recommended within one year due to inadequate bowel
preparation: This QCDR measure ensures patients with inadequate bowel prep receive a repeat screening or
surveillance colonoscopy or an alternate tier I or tier 2 colorectal cancer screening modality within one year.
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The following broadly applicable MIPS quality measures are relevant to clinicians who specialize in gastroenterology. The
quality measures below assess for age-specific screenings, and follow-up actions for select measures:
•
0130: Documentation of Current Medications in the Medical Record: This MIPS quality measure bases performance
on clinicians documenting the list of current medications using all immediate resources for capture of this important
clinical topic.
•
0226: Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention: This MIPS quality measure
ensures patients are screened for tobacco use and if screened positive receive tobacco cessation intervention.
•
0374: Closing the Referral Loop: Receipt of Specialist Report: This MIPS quality measure is attributable to the
clinician referring the patient and ensures report receival from the referred to clinician, closing the communication
loop.
0487: Screening for Social Drivers of Health: This MIPS quality measure ensures adults are screened for food
•
insecurity, housing instability, transportation needs, utility difficulties, and interpersonal safety.
0503: Gains in Patient Activation Measure (PAM®) Scores at 12 Months: This MIPS quality measure ensures capture
•
of the patient voice and experience of care related to the patient's understanding and confidence in the clinician's
ability to manage their health and be an active partner in the health care journey.
62594
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
Improvement Activities
We reviewed the Improvement Activities Inventory and considered feedback received during the 2025 MVP candidate feedback
period to determine the set of improvement activities to include in this MVP. We are proposing to include 11 improvement
activities that reflect actions and processes undertaken by clinicians who specialize in gastroenterology, as well as activities that
promote patient engagement and patient-centeredness, health equity, shared decision making, and care coordination. These
improvement activities provide opportunities for clinicians, in collaboration with patients, to drive outcomes and improve quality
of care. The following improvement activities are proposed for inclusion in this MVP:
•
IA_AHE_3: Promote Use of Patient-Reported Outcome Tools
•
IA_AHE_ 6: Provide Education Opportunities for New Clinicians
•
IA_AHE_9: Implement Food Insecurity and Nutrition Risk Identification and Treatment Protocols
•
IA_BE_4: Engagement of patients through implementation of improvements in patient portal
•
IA_CC_7: Regular training in care coordination
•
IA_CC_9: Implementation of practices/processes for developing regular individual care plans
•
IA_CC_ I 0: Care transition documentation practice improvements
•
IA_CC_13: Practice improvements to align with OpenNotes principles
•
IA ERP 6: COVID-19 Vaccine Achievement for Practice Staff
•
IA_MVP: Practice-Wide Quality Improvement in MIPS Value Pathways
•
IA PCMH: Electronic submission of Patient Centered Medical Home accreditation
We are proposing to modify the IA_BE_4: Engagement of patients through implementation of improvements in patient portal
improvement activity. which includes a proposed activity title update. Please see Appendix 2, Improvement Activities: Table
Group B of this proposed rule for all proposed revisions to this activity.
Cost Measures
We are proposing to include two MIPS cost measures within the cost performance category of this MVP, which apply to the
clinical topic of gastroenterology. We reviewed the MIPS cost measure inventory and considered feedback received during the
2025 MVP candidate feedback period to determine the set of cost measures to include in this MVP. The following cost measures
provide a meaningful assessment of the clinical care for clinicians who specialize in gastroenterology, including colonoscopies
and broader gastroenterology care, and align with other measures and activities within this MVP:
•
Screening/Surveillance Colonoscopy: This MIPS episode-based cost measure assesses costs associated with screening
or surveillance colonoscopy procedures. This measure aligns with quality measures such as Q 113: Colorectal Cancer
Screening or Q320: Appropriate Follow-Up Interval for Normal Colonoscopy in Average Risk Patients.
•
Total Per Capita Cost (TPCC): This MIPS cost measure assesses the overall cost of care delivered to a Medicare
patient with a focus on the primary care the patient receives from their providers. Gastroenterologists are included in
attribution for the TPCC measure as they may provide broad, ongoing care to their patients, which is in line with the
intent of the TPCC measure.
Gastroenterology Care MVP Tables
As stated in the introduction of this appendix, we considered measures and improvement activities available within the MIPS
inventory and selected those we determined best fit the clinical concept of the proposed Gastroenterology Care MVP. We request
comment on the measures and activities included in this MVP.
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Symbol Key:
Single asterisk(*): existing measures and improvement activities with proposed revisions
Double asterisk(**): measures and improvement activities only available when included in an MVP
Single exclamation point(!): high priority measures
Double exclamation point(!!): outcome measures
Tilde(-): measures and improvement activities that include a health equity component
Percent(%): attestation to IA_pCMH: Electronic submission of Patient Centered Medical Home accreditation provides full credit
for the improvement activity performance category
Pound sign (#): QCDR measures pending testing data
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
(*) Qt 13: Colorectal Cancer Screening
(Collection Type: Medicare Part B Claims
Specifications, eCQM Specifications, MIPS
CQMs Specifications)
(*)(!) Q130: Documentation of Current
Medications in the Medical Record
(Collection Type: eCQM Specifications,
MIPS CQMs Specifications)
(*)(!) Q185: Colonoscopy Interval for
Patients with a History of Adenomatous
Polyps - Avoidance oflnappropriate Use
(Collection Type: MIPS CQMs
Specifications)
Q226: Preventive Care and Screening:
Tobacco Use: Screening and Cessation
Intervention
(Collection Type: Medicare Part B Claims
Specifications, eCQM Specifications, MIPS
CQMs Specifications)
Q275: Inflammatory Bowel Disease (IBD):
Assessment of Hepatitis B Virus (HBV)
Status Before Initiating Anti-TNF (Tumor
Necrosis Factor) Therapy
(Collection Type: MIPS CQMs
Specifications)
(*)(!) Q320: Appropriate Follow-Up Interval
for Normal Colonoscopy in Average Risk
Patients
(Collection Type: Medicare Part B Claims
Specifications, Ml PS CQMs Specifications)
(*)(!) Q374: Closing the Referral Loop:
Receipt of Specialist Report
(Collection Type: eCQM Specifications,
MIPS CQMs Specifications)
Q400: One-Time Screening for Hepatitis C
Virus (HCV) and Treatment Initiation
(Collection Type: MIPS CQMs
Specifications)
(~) IA_AHE_3: Promote use of PatientReported Outcome Tools
(High)
62595
Screening/Surveillance Colonoscopy
Total Per Capita Cost (TPCC)
(~) IA_AHE_6: Provide Education
Opportunities for New Clinicians
(High)
(~) IA_AHE_9: Implement Food Insecurity
and Nutrition Risk Identification and
Treatment Protocols
(Medium)
(*) IA_BE_4: Engagement of patients
through implementation of improvements in
patient portal
(Medium)
IA_CC_7: Regular training in care
coordination
(Medium)
(~) IA_CC_9: Implementation of
practices/processes for developing regular
individual care plans
(Medium)
(~) IA_CC_lO: Care transition
documentation practice improvements
(Medium)
IA_CC_13: Practice improvements to align
with OpenNotes principles
(Medium)
(*) IA_ERP_6: COVID-19 Vaccine
Achievement for Practice Staff
(Medium)
(**) IA_MVP: Practice-Wide Quality
Improvement in MIPS Value Pathways
(High)
(%) IA_PCMH: Electronic submission of
Patient Centered Medical Home accreditation
Q401: Hepatitis C: Screening for
Hepatocellular Carcinoma (HCC) in Patients
with Cirrhosis
(Collection Type: MIPS CQMs
Specifications)
(~)(!) Q487: Screening for Social Drivers of
Health
(Collection Type: MIPS CQMs
Specifications)
(*)(!!) Q503: Gains in Patient Activation
Measure (PAM®) Scores at 12 Months
(Collection Type: MIPS CQMs
Specifications)
(!!)(#) GIQIC26: Screening Colonoscopy
Adenoma Detection Rate
(Collection Type: QCDR)
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(!) GIQIC23: Appropriate follow-up interval
based on pathology findings in screening
colonoscopy
(Collection Type: QCDR)
62596
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
(!) NHCR4: Repeat screening or surveillance
colonoscopy recommended within one year
due to inadequate bowel preparation
DR
Collection T
(!!) Q479: Hospital-Wide, 30-Day, All-Cause Unplanned
Readmission (HWR) Rate for the Merit-Based Incentive Payment
Systems (MIPS) Groups
(Collection Type: Administrative Claims)
(!!) Q484: Clinician and Clinician Group Risk-standardized Hospital
Admission Rates for Patients with Multiple Chronic Conditions
(Collection Type: Administrative Claims)
Security Risk Analysis
High Priority Practices Safety Assurance Factors for EHR Resilience
Guide (SAFER Guide)
e-Prescribing
Query of Prescription Drug Monitoring Program (PDMP)
Provide Patients Electronic Access to Their Health Information
Support Electronic Referral Loops By Sending Health Information
AND
Support Electronic Referral Loops By Receiving and Reconciling
Health Information
OR
Health Information Exchange (HIE) Bi-Directional Exchange
OR
Enabling Exchange Under the Trusted Exchange Framework and
Common Agreement (TEFCA)
Immunization Registry Reporting
Syndromic Surveillance Reporting (Optional)
Electronic Case Reporting
Public Health Registry Reporting (Optional)
Clinical Data Registry Reporting (Optional)
Actions to Limit or Restrict Compatibility or Interoperability of
CEHRT
ONC Direct Review Attestation
A.4 Optimal Care for Patients with Urologic Conditions MVP
The proposed Optimal Care for Patients with Urologic Conditions MVP focuses on assessing optimal care for patients treated for
a broad range of urologic conditions, including kidney stones, urinary incontinence, bladder cancer, and prostate cancer. This
MVP would be most applicable to clinicians who treat patients within the practice urology including general urologists, urology
oncologists, and sub-specialists focused on urology care for women, including nonphysician practitioners (NPPs) such as nurse
practitioners and physician assistants.
Quality Measures
The following quality measures provide a meaningful and comprehensive assessment of the clinical care for clinicians who
specialize in urology:
•
0050: Urinarv Incontinence: Plan of Care for Urinary Incontinence in Women Aged 65 Years and Older: This MIPS
quality measure ensures patients have a documented plan of care for urinary incontinence at least once within 12
months.
•
0462: Bone Density Evaluation for Patients with Prostate Cancer and Receiving Androgen Deprivation Therapy: This
MIPS quality measure ensures patients with prostate cancer currently on or starting androgen deprivation therapy
(ADT), with an intent for treatment greater than or equal to 12 months, have a bone density evaluation prior to starting
or within 3 months after the start of ADT.
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We are proposing to include nine MIPS quality measures and five QCDR measure within the quality performance category of
this MVP, which are specific to the clinical topic of urology. We reviewed the MIPS quality measure inventory and considered
feedback received during the 2025 MVP candidate feedback period to determine which quality measures best represent the
clinical topic of this MVP.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
•
•
•
•
•
•
•
62597
0476: Urinary Symptom Score Change 6-12 Months After Diagnosis of Benign Prostatic Hypemlasia: This MIPS
quality measure assesses for improvement in urinary symptoms for patients with a diagnosis of benign prostatic
hyperplasia based upon the International Prostate Symptoms Score (IPSS) or American Urological Association (AUA)
Symptom Index (SI).
0481: Intravesical Bacillus-Calmette Guerin for Non-muscle Invasive Bladder Cancer: This MIPS quality measure
ensures patients initially diagnosed with non-muscle invasive bladder cancer have treatment initiated within 6 months
of the cancer staging.
AQUAS: Hospital Admissions or Infectious Complications Within 30 days of Prostate Biopsy: This QCDR measure
assesses the number of patients who have urinary retention, infection, or a new antibiotic prescription at least 24 hours
after and within 30 days of a prostate biopsy or inpatient consultation or require hospitalization within 30 days of
prostate biopsy.
AOUA14: Stones: Repeat Shock Wave Lithotripsy (SWL) Within 6 Months of Initial Treatment: This QCDR measure
assesses the number of patients who had a repeat shock wave lithotripsy procedure within the 6 months of the initial
treatment.
AOUA15: Stones: Urinalysis or Urine Culture Performed Before Surgical Stone Procedures: This QCDR measure
ensures patients have a urinalysis or culture within 14 days prior to surgical stone procedures.
AOUAI 6: Non-Muscle Invasive Bladder Cancer: Repeat Transurethral Resection of Bladder Tumor (TURBT) for Tl
disease: This QCDR measure assesses the number of patients who undergo a second TURBT within 6 weeks of the
initial procedure.
MUSIC4: Prostate Cancer: Active Surveillance/Watchful Waiting for Newly Diagnosed Low-Risk Prostate Cancer
Patients: This QCDR measure ensures newly diagnosed low-risk prostate cancer patients are managed via active
surveillance or watchful waiting to maintain the patient's quality of life.
The following broadly applicable MIPS quality measures are relevant to clinicians who specialize in urology. The measures
assess for age-specific screenings, and follow-up actions for select measures, in addition to recommended vaccinations:
•
0318: Falls: Screening for Future Fall Risk: This MIPS quality measure ensures patients are screened each
performance period for future fall risk.
0321: CAHPS for MIPS Clinician/Group Survey: This survey provides direct input from patients and their experience
•
regarding timely care, effective communication, shared decision making, care coordination, promotion of health and
education, completion of health status/functionality, and courtesy of office staff.
•
0358: Patient-Centered Surgical Risk Assessment and Communication: This MIPS quality measure ensures a
personalized surgical risk assessment is completed on each patient using a validated risk calculator or multiinstitutional clinical data prior to the surgery along with discussion of the identified risks with the surgeon.
0487: Screening for Social Drivers of Health: This MIPS quality measure ensures adults are screened for food
•
insecurity, housing instability, transportation needs, utility difficulties, and interpersonal safety.
•
0503: Gains in Patient Activation Measure (PAM®) Scores at 12 Months: This MIPS quality measure ensures capture
of the patient voice and experience of care related to the patient's understanding and confidence in the clinician's
ability to manage their health and be an active partner in the health care journey.
We reviewed the Improvement Activities Inventory and considered feedback received during the 2025 MVP candidate feedback
period to determine the set of improvement activities to include in this MVP. We are proposing to include 17 improvement
activities that reflect actions and processes undertaken by clinicians who specialize in urology, as well as activities that promote
patient engagement and patient-centeredness, health equity, shared decision making, and care coordination. These improvement
activities provide opportunities for clinicians, in collaboration with patients, to drive outcomes and improve quality of care. The
following improvement activities are proposed for inclusion in this MVP:
•
IA_AHE_3: Promote Use of Patient-Reported Outcome Tools
•
IA_AHE_12: Practice Improvements that Engage Community Resources to Address Drivers of Health
•
IA_BE_6: Regularly Assess Patient Experience of Care and Follow Up on Findings
•
IA_BE_15: Engagement of patients, family and caregivers in developing a plan of care
•
IA_CC_7: Regular training in care coordination
•
IA_CC_13: Practice improvements to align with OpenNotes principles
•
IA_CC_17: Patient Navigator Program
•
IA_EPA_2: Use oftelehealth services that expand practice access
•
IA ERP 6: COVID-19 Vaccine Achievement for Practice Staff
•
IA_MVP: Practice-Wide Quality Improvement in MIPS Value Pathways
•
IA PCMH: Electronic submission of Patient Centered Medical Home accreditation
•
IA_PM_17: Participation in Population Health Research
•
IA_PM_21: Advance Care Planning
•
IA_PSPA_7: Use ofQCDR data for ongoing practice assessment and improvements
•
IA_PSPA _ 12: Participation in private payer CPIA
•
IA_PSPA_19: Implementation of formal quality improvement methods, practice changes or other practice
improvement processes
•
IA_PSPA _ 21: Implementation of fall screening and assessment programs
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Improvement Activities
62598
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
Cost Measures
We are proposing to include three MIPS cost measures within the cost performance category of this MVP, which apply to the
clinical topic of urology. We reviewed the MIPS cost measure inventory and considered feedback received during the 2025 MVP
candidate feedback period to determine the set of cost measures to include in this MVP. The following cost measures provide a
meaningful assessment of the clinical care for clinicians who specialize in urology and align with other measures and activities
within this MVP:
•
Medicare Spending Per Beneficiary (MSPB) Clinician: This MIPS cost measure applies to clinicians providing care in
inpatient hospitals, including those who treat patients with urology-related conditions or procedures.
•
Renal or Ureteral Stone Surgical Treatment: This MIPS episode-based cost measure assesses costs associated with
surgical treatment for renal or ureteral stones. This also aligns with quality measures such as AQUA14: Stones: Repeat
Shock Wave Lithotripsy (SWL) Within 6 Months oflnitial Treatment or AQUA15: Stones: Urinalysis or Urine
Culture Performed Before Surgical Stone Procedures.
•
Prostate Cancer: This proposed MIPS episode-based cost measure would assess costs associated with prostate cancer.
This also aligns with quality measures such as Q462: Bone Density Evaluation for Patients with Prostate Cancer and
Receiving Androgen Deprivation Therapy or MUSIC4: Prostate Cancer: Active Surveillance/Watchful Waiting for
Newly Diagnosed Low-Risk Prostate Cancer Patients. We note that this is a new cost measure we are proposing to
adopt as described in section IV.A.4.e.(2)(a)(iii)ofthis proposed rule.
Optimal Care for Patients with Urologic Conditions MVP Tables
As stated in the introduction of this appendix, we considered measures and improvement activities available within the MIPS
inventory and selected those we determined best fit the clinical concept of the proposed Optimal Care for Patients with Urologic
Conditions MVP. We request comment on the measures and activities included in this MVP.
Symbol Key:
Carat symbol("): new proposed measures and improvement activities
Single asterisk(*): existing measures and improvement activities with proposed revisions
Double asterisk(**): measures and improvement activities only available when included in an MVP
Single exclamation point(!): high priority measures
Double exclamation point(!!): outcome measures
Tilde(~): measures and improvement activities that include a health equity component
Percent(%): attestation to IA_PCMH: Electronic submission of Patient Centered Medical Home accreditation provides full credit
for the improvement activity performance category
TABLE A.4a: 0 timal Care for Patients with Urolo ic Conditions MVP Measures and Im
(!) Q318: Falls: Screening for Future Fall
Risk
(Collection Type: eCQM Specifications)
(!) Q321: CAHPS for MIPS Clinician/Group
Survey
(Collection Type: CSV)
(!) Q358: Patient-Centered Surgical Risk
Assessment and Communication
(Collection Type: MIPS CQMs
Specifications)
lotter on DSK11XQN23PROD with PROPOSALS2
(*) Q462: Bone Density Evaluation for
Patients with Prostate Cancer and Receiving
Androgen Deprivation Therapy
(Collection Type: eCQM Specifications)
(!!) Q476: Urinary Symptom Score Change
6-12 Months After Diagnosis of Benign
Prostatic Hyperplasia
(Collection Type: eCQM Specifications)
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(~) IA_AHE_3: Promote use of PatientReported Outcome Tools
(High)
(~) IA_AHE_12: Practice Improvements that
Engage Community Resources to Address
Drivers of Health
(High)
Renal or Ureteral Stone Surgical
Treatment
Medicare Spending Per Beneficiary
(MSPB) Clinician
(") Prostate Cancer
IA_BE_6: Regularly Assess Patient
Experience of Care and Follow Up on
Findings
(High)
IA_BE_l5: Engagement of patients, family
and caregivers in developing a plan of care
(Medium)
IA_CC_7: Regular training in care
coordination
(Medium)
IA_CC_13: Practice improvements to align
with OpenNotes principles
(Medium)
IA_CC_17: Patient Navigator Program
(High)
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(!) Q050: Urinary Incontinence: Plan of Care
for Urinary Incontinence in Women Aged 65
Years and Older
(Collection Type: MIPS CQMs
Specifications)
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
H(!) Q487: Screening for Social Drivers of
Health
(Collection Type: MIPS CQMs
Specifications)
(*)(!!) Q503: Gains in Patient Activation
Measure (PAM®) Scores at 12 Months
(Collection Type: MIPS CQMs
Specifications)
(!!) AQUAS: Hospital Admissions or
Infectious Complications Within 30 days of
Prostate Biopsy
(Collection Type: QCDR)
(!!) AQUA14: Stones: Repeat Shock Wave
Lithotripsy (SWL) Within 6 Months of Initial
Treatment
(Collection Type: QCDR)
(!) AQUA 15: Stones: Urinalysis or Urine
Culture Performed Before Surgical Stone
Procedures
(Collection Type: QCDR)
AQlJA16: Non-Muscle Invasive Bladder
Cancer: Repeat Transurethral Resection of
Bladder Tumor (TURBT) for Tl disease
(Collection Type: QCDR)
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(!) MUSIC4: Prostate Cancer: Active
Surveillance/Watchful Waiting for Newly
Diagnosed Low-Risk Prostate Cancer Patients
(Collection Type: QCDR)
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IA_EPA_2: Use oftelehealth services that
expand practice access
(Medium)
(*) IA_ERP_6: COVID-19 Vaccine
Achievement for Practice Staff
(Medium)
(**) IA_MVP: Practice-Wide Quality
Improvement in MIPS Value Pathways
(High)
(%) IA_PCMH: Electronic submission of
Patient Centered Medical Home accreditation
IA_PM_l 7: Participation in Population
Health Research
(Medium)
IA_PM_21: Advance Care Planning
(Medium)
H IA_PSPA_7: Use ofQCDR data for
ongoing practice assessment and
improvements
(Medium)
IA_PSPA_12: Participation in private payer
CPIA
(Medium)
IA_PSPA_19: Implementation of formal
quality improvement methods, practice
changes or other practice improvement
processes
(Medium)
IA_PSPA_21: Implementation of fall
screening and assessment programs
(Medium)
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(!) Q481: Intravesical Bacillus-Calmette
Guerin for Non-muscle Invasive Bladder
Cancer
(Collection Type: eCQM Specifications)
62599
62600
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
(!!) Q479: Hospital-Wide, 30-Day, All-Cause Unplanned
Security Risk Analysis
Readmission (HWR) Rate for the Merit-Based Incentive Payment
Systems (MIPS) Groups
(Collection Type: Administrative Claims)
High Priority Practices Safety Assurance Factors for EHR Resilience
Guide (SAFER Guide)
(!!) Q484: Clinician and Clinician Group Risk-standardized Hospital
Admission Rates for Patients with Multiple Chronic Conditions
(Collection Type: Administrative Claims)
e-Prescribing
Query of Prescription Drug Monitoring Program (POMP)
Provide Patients Electronic Access to Their Health Information
Support Electronic Referral Loops By Sending Health Information
AND
Support Electronic Referral Loops By Receiving and Reconciling
Health Information
OR
Health Information Exchange (HIE) Bi-Directional Exchange
OR
Enabling Exchange Under the Trusted Exchange Framework and
Common Agreement (TEFCA)
Immunization Registry Reporting
Syndromic Surveillance Reporting (Optional)
Electronic Case Reporting
Public Health Registry Reporting (Optional)
Clinical Data Registry Reporting (Optional)
Actions to Limit or Restrict Compatibility or Interoperability of
CEHRT
ONC Direct Review Attestation
A.5 Pulmonology Care MVP
The proposed Pulmonology Care MVP focuses on assessing optimal care for patients treated for a broad range of pulmonology
conditions including COPD, asthma, sleep apnea, and general pulmonology. This MVP would be most applicable to clinicians
who treat patients within the practice ofpulmonology and sleep medicine, including nonphysician practitioners (NPPs) such as
nurse practitioners, and physician assistants.
Quality Measures
The following quality measures provide a meaningful and comprehensive assessment of the clinical care for clinicians who
specialize in pulmonology:
0052: Chronic Obstructive Pulmonary Disease (COPD): Spirometry Evaluation for Long-Acting Inhaled
•
Bronchodilator Therapy: This MIPS quality measure ensures adults 18 and older diagnosed with COPD have
spirometry results documented airflow obstruction confirming diagnosis, and have been prescribed a long-acting
bronchodilator to provide proper treatment if symptomatic.
•
0277: Sleep Apnea: Severity Assessment at Initial Diagnosis: This MIPS quality measure ensures adults diagnosed
with obstructive sleep apnea have an appropriate assessment completed and documented at the time of diagnosis or
measured within 2 months of initial evaluation for suspected obstructive sleep apnea.
•
0279: Sleep Apnea: Assessment of Adherence to Obstructive Sleep Apnea (OSA) Therapy: This MIPS quality
measure ensures patients with a diagnosis of obstructive sleep apnea (OSA) who were prescribed an evidence-based
therapy with documentation that adherence to the therapy was assessed annually.
•
0398: Optimal Asthma Control: This MIPS quality measure assesses pediatric and adult patients to ensure their asthma
is well-controlled as demonstrated by one of three age-appropriate patient reported outcome tools and not at risk for
exacerbation.
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We are proposing to include nine MIPS quality measures and one QCDR measure within the quality performance category of this
MVP, which are specific to the clinical topic ofpulmonology. We reviewed the MIPS quality measure inventory and considered
feedback received during the 2025 MVP candidate feedback period to determine which quality measures best represent the
clinical topic of this MVP.
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
•
62601
ACEP25: Tobacco Use: Screening and Cessation Intervention for Patients with Asthma and COPD: This QCDR
measure ensures patients with asthma or COPD seen in the emergency department receive tobacco cessation if screened
positive for tobacco use.
The following broadly applicable MIPS quality measures are relevant to clinicians who specialize in pulmonology care. The
measures assess for age-specific screenings, and follow-up actions for select measures, in addition to recommended vaccinations:
•
0047: Advance Care Plan: This MIPS quality measure assesses for medical record documentation of an advance care
plan or surrogate decisions maker.
0128: Preventive Care and Screening: Body Mass Index (BMI) Screening and Follow-Up Plan: This MIPS quality
•
measure assesses patients for a BMI documented with a follow-up plan documented if their most recent documented
BMI was outside of normal parameters.
•
0226: Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention: This MIPS quality measure
ensures patients are screened for tobacco use and if screened positive receive tobacco cessation intervention.
0487: Screening for Social Drivers of Health: This MIPS quality measure ensures adults are screened for food
•
insecurity, housing instability, transportation needs, utility difficulties, and interpersonal safety.
•
0503: Gains in Patient Activation Measure (PAM®) Scores at 12 Months: This MIPS quality measure ensures capture
of the patient voice and experience of care related to the patient's understanding and confidence in the clinician's
ability to manage their health and be an active partner in the health care journey.
Improvement Activities
We reviewed the Improvement Activities Inventory and considered feedback received during the 2025 MVP candidate feedback
period to determine the set of improvement activities to include in this MVP. We are proposing to include 11 improvement
activities that reflect actions and processes undertaken by clinicians who specialize in pulmonology care, as well as activities that
promote patient engagement and patient-centeredness, health equity, shared decision making, and care coordination. These
improvement activities provide opportunities for clinicians, in collaboration with patients, to drive outcomes and improve quality
of care. The following improvement activities are proposed for inclusion in this MVP:
•
IA_AHE_3: Promote Use of Patient-Reported Outcome Tools
•
IA_AHE_9: Implement Food Insecurity and Nutrition Risk Identification and Treatment Protocols
•
IA_AHE_ 12: Practice Improvements that Engage Community Resources to Address Drivers of Health
•
IA_BE_23: Integration of patient coaching practices between visits
•
IA_CC_9: Implementation of practices/processes for developing regular individual care plans
•
IA_EPA_2: Use oftelehealth services that expand practice access
•
IA_ERP_6: COVID-19 Vaccine Achievement for Practice Staff
•
IA_MVP: Practice-Wide Quality Improvement in MIPS Value Pathways
IA PCMH: Electronic submission of Patient Centered Medical Home accreditation
•
•
IA_PM_13: Chronic care and preventative care management for empaneled patients
•
IA_PM_l6: Implementation of medication management practice improvements
Cost Measures
We are proposing to include two MIPS cost measures within the cost performance category of this MVP, which apply to the
clinical topic ofpulmonology care. We reviewed the MIPS cost measure inventory and considered feedback received during the
2025 MVP candidate feedback period to determine the set of cost measures to include in this MVP. The following cost measures
provide a meaningful assessment of the clinical care for clinicians who specialize in pulmonology and align with other measures
and activities within this MVP:
•
Inpatient Chronic Obstructive Pulmonary Disease (COPD) Exacerbation: This MIPS episode-based cost measure
assesses costs associated with inpatient treatment for an acute exacerbation ofCOPD. This also aligns with quality
measures such as Q052: Chronic Obstructive Pulmonary Disease (COPD): Spirometry Evaluation for Long-Acting
Inhaled Bronchodilator Therapy.
•
Asthma/Chronic Obstructive Pulmonary Disease (COPD}: This MIPS episode-based cost measure assesses costs
associated with medical care to manage and treat asthma or COPD. This also aligns with quality measures such as
Q398: Optimal Asthma Control or ACEP25: Tobacco Use: Screening and Cessation Intervention for Patients with
Asthma and COPD.
Pulmonology Care MVP Tables
Symbol Key:
Single asterisk(*): existing measures and improvement activities with proposed revisions
Double asterisk(**): measures and improvement activities only available when included in an MVP
Single exclamation point(!): high priority measures
Double exclamation point(!!): outcome measures
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As stated in the introduction of this appendix, we considered measures and improvement activities available within the MIPS
inventory and selected those we determined best fit the clinical concept of the proposed Pulmonology Care MVP. We request
comment on the measures and activities included in this MVP.
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Tilde(-): measures and improvement activities that include a health equity component
Percent(%): attestation to IA_PCMH: Electronic submission of Patient Centered Medical Home accreditation provides full credit
for the improvement activity performance category
(*)(!) Q047: Advance Care Plan
(Collection Type: Medicare Part B Claims,
MIPS CQMs Specifications)
(~) IA_AHE_3: Promote use of PatientReported Outcome Tools
(High)
Q052: Chronic Obstructive Pulmonary
Disease (COPD): Spirometry Evaluation and
Long-Acting Inhaled Bronchodilator Therapy
(Collection Type: MIPS CQMs
Specifications)
(~) IA_AHE_9: Implement Food Insecurity
and Nutrition Risk Identification and
Treatment Protocols
(Medium)
(**) Q128: Preventive Care and Screening:
Body Mass Index (BMI) Screening and
Follow-Up Plan
(Collection Type: Medicare Part B Claims
Specifications, eCQM Specifications, MIPS
CQMs Specifications)
IA_BE_23: Integration of patient coaching
practices between visits
(Medium)
(~) IA_CC_9: Implementation of
practices/processes for developing regular
individual care plans
(Medium)
(*) Q277: Sleep Apnea: Severity Assessment
IA_EPA_2: Use oftelehealth services that
expand practice access
(Medium)
Q279: Sleep Apnea: Assessment of
Adherence to Obstructive Sleep Apnea (OSA)
Therapy
(Collection Type: MIPS CQMs
Specifications)
(!!) Q398: Optimal Asthma Control
(Collection Type: MIPS CQMs
Specifications)
Asthma/Chronic Obstructive Pulmonary
Disease (COPD)
(~) IA_AHE_12: Practice Improvements that
Engage Community Resources to Address
Drivers of Health
(High)
Q226: Preventive Care and Screening:
Tobacco Use: Screening and Cessation
Intervention
(Collection Type: Medicare Part B Claims
Specifications, eCQM Specifications, MIPS
CQMs Specifications)
at Initial Diagnosis
(Collection Type: MIPS CQMs
Specifications)
Inpatient Chronic Obstructive Pulmonary
Disease (COPD) Exacerbation
(*) IA_ERP_6: COVID-19 Vaccine
Achievement for Practice Staff
(Medium)
(**) IA_MVP: Practice-Wide Quality
Improvement in MIPS Value Pathways
(High)
(%) IA_PCMH: Electronic submission of
Patient Centered Medical Home accreditation
(~)(!) Q487: Screening for Social Drivers of
Health
(Collection Type: MIPS CQMs
Specifications)
(*)(!!) Q503: Gains in Patient Activation
Measure (PAM®) Scores at 12 Months
(Collection Type: MIPS CQMs
Specifications)
IA_PM_13: Chronic care and preventative
care management for empaneled patients
(Medium)
IA_PM_16: Implementation of medication
management practice improvements
(Medium)
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ACEP25: Tobacco Use: Screening and
Cessation Intervention for Patients with
Asthma and COPD
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(!!) Q479: Hospital-Wide, 30-Day, All-Cause Unplanned
Readmission (HWR) Rate for the Merit-Based Incentive Payment
Systems (MIPS) Groups
(Collection Type: Administrative Claims)
(!!) Q484: Clinician and Clinician Group Risk-standardized Hospital
Admission Rates for Patients with Multiple Chronic Conditions
(Collection Type: Administrative Claims)
62603
Security Risk Analysis
High Priority Practices Safety Assurance Factors for EHR Resilience
Guide (SAFER Guide)
e-Prescribing
Query of Prescription Drug Monitoring Program (POMP)
Provide Patients Electronic Access to Their Health Information
Support Electronic Referral Loops By Sending Health Information
AND
Support Electronic Referral Loops By Receiving and Reconciling
Health Information
OR
Health Information Exchange (IDE) Bi-Directional Exchange
OR
Enabling Exchange Under the Trusted Exchange Framework and
Common Agreement (TEFCA)
Immunization Registry Reporting
Syndromic Surveillance Reporting (Optional)
Electronic Case Reporting
Public Health Registry Reporting (Optional)
Clinical Data Registry Reporting (Optional)
Actions to Limit or Restrict Compatibility or Interoperability of
CEHRT
ONC Direct Review Attestation
A.6 Surgical Care MVP
The proposed Surgical Care MVP focuses on the clinical theme of surgery. This MVP would be most applicable to clinicians
who treat patients within the surgical settings of general surgery, neurosurgery, cardiothoracic surgery, anesthesiologists,
including nonphysician practitioners (NPPs) such as certified registered nurse anesthetists (CRNAs), nurse practitioners, and
physician assistants.
Quality Measures
The following quality measures provide a meaningful and comprehensive assessment of the clinical care for clinicians who
specialize in surgery:
•
0164: Coronary Artery Bypass Graft (CABG}: Prolonged Intubation: This MIPS quality measure identifies patients
who undergo an isolated CABG and require intubation > 24 hours following exit from the operating room.
•
0167: Coronary Artery Bypass Graft (CABG}: Postoperative Renal Failure: This MIPS quality measure assesses
patients for postoperative renal failure or who require dialysis after CABG.
•
0168: Coronary Artery Bypass Graft (CABG}: Surgical Re-Exploration: This MIPS quality measure identifies patients
who return to the operating room for surgical re-exploration following an isolated CABG surgery during the current
hospitalization.
•
0264: Sentinel Lymph Node Biopsy for Invasive Breast Cancer: This MIPS quality measure assesses the percentage of
patients with a diagnosis of primary invasive breast cancer who undergo a sentinel lymph node procedure.
•
0354: Anastomotic Leak Intervention: This MIPS quality measure evaluates for anastomotic leak intervention
following gastric bypass or colectomy surgery.
•
0355: Unplanned Reoperation within the 30-Day Postoperative Period: This MIPS quality measure evaluates for an
unplanned reoperation within 30 days of a denominator eligible procedure.
•
0357: Surgical Site Infection (SSI): This MIPS quality measure evaluates for SSI within 30 days of a denominator
eligible procedure.
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We are proposing to include 15 MIPS quality measures within the quality performance category of this MVP, which are specific
to the clinical theme of surgery. We reviewed the MIPS quality measure inventory and considered feedback received during the
2025 MVP candidate feedback period to determine which quality measures best represent the clinical topic of this MVP.
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•
•
•
•
•
0358: Patient-Centered Surgical Risk Assessment and Communication: This MIPS quality measure ensures a
personalized surgical risk assessment is completed on each patient using a validated risk calculator or multiinstitutional clinical data prior to the surgery along with discussion of the identified risks with the surgeon.
0445: Risk-Adjusted Operative Mortality for Coronary Artery Bypass Graft (CABG}: This MIPS quality measure
assesses patients undergoing isolated CABG for quality outcomes by identifying the percentage of patients who die,
including all deaths occurring during CABG hospitalization and deaths occurring after discharge up to 30 days post
CABG surgery.
0459: Back Pain After Lumbar Surgery: This MIPS quality measure evaluates patients for a decrease in back pain post
lumbar surgery based upon predetermined benchmarks.
0461: Leg Pain After Lumbar Surgery: This MIPS quality measure evaluates patients for a decrease in leg pain post
lumbar surgery based upon predetermined benchmarks.
0471: Functional Status After Lumbar Surgery: This MIPS quality measure evaluates patients for an increase in
functional status post lumbar surgery based upon predetermined benchmarks.
The following broadly applicable MIPS quality measures are relevant to clinicians who treat patients in surgical settings. The
measures assess for age-specific screenings, and follow-up actions for select measures, in addition to recommended vaccinations:
•
0047: Advance Care Plan: This MIPS quality measure assesses for medical record documentation of an advance care
plan or surrogate decisions maker.
•
0226: Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention: This MIPS quality measure
ensures patients are screened for tobacco use and if screened positive receive tobacco cessation intervention.
•
0487: Screening for Social Drivers of Health: This MIPS quality measure ensures adults are screened for food
insecurity, housing instability, transportation needs, utility difficulties, and interpersonal safety.
Improvement Activities
We reviewed the Improvement Activities Inventory and considered feedback received during the 2025 MVP candidate feedback
period to determine the set of improvement activities to include in this MVP. We are proposing to include 12 improvement
activities that reflect actions and processes undertaken by surgical care clinicians, as well as activities that promote patient
engagement and patient-centeredness, health equity, shared decision making, and care coordination. These improvement
activities provide opportunities for clinicians, in collaboration with patients, to drive outcomes and improve quality of care. The
following improvement activities are proposed for inclusion in this MVP:
•
IA_AHE_3: Promote Use of Patient-Reported Outcome Tools
•
IA_AHE_9: Implement Food Insecurity and Nutrition Risk Identification and Treatment Protocols
•
IA~BE_12: Use evidence-based decision aids to support shared decision-making
•
IA CC 15: PSH Care Coordination
•
IA_CC_ 17: Patient Navigator Program
•
IA_CC_18: Relationship-Centered Communication
•
IA_ERP_6: COVID-19 Vaccine Achievement for Practice Staff
•
IA_MVP: Practice-Wide Quality Improvement in MIPS Value Pathways
•
IA_PCMH: Electronic submission of Patient Centered Medical Home accreditation
•
IA_PM_ 11: Regular review practices in place on targeted patient population needs
•
IA_PSPA_7: Use ofQCDR data for ongoing practice assessment and improvements
IA_pSPA_8: Use of Patient Safety Tools
•
We are proposing to include six MIPS cost measures within the cost performance category of this MVP, which apply to the
clinical theme of surgical care. We reviewed the MIPS cost measure inventory and considered feedback received during the 2025
MVP candidate feedback period to determine the set of cost measures to include in this MVP. The following cost measures
provide a meaningful assessment of the clinical care for clinicians who specialize in surgical care and align with other measures
and activities within this MVP:
•
Colon and Rectal Resection: This MIPS episode-based cost measure assesses costs associated with colon or rectal
resections for either benign or malignant indications.
•
Femoral or Inguinal Hernia Repair: This MIPS episode-based cost measure assesses costs associated with surgical
procedures to repair a femoral or inguinal hernia
•
Lumbar Spine Fusion for Degenerative Disease, 1-3 Levels: This MIPS episode-based cost measure assesses costs
associated with surgery for lumbar spine fusion. This also aligns with quality measures such as Q4 71: Functional
Status After Lumbar Surgery or Q461: Leg Pain After Lumbar Surgery.
•
Lumpectomy, Partial Mastectomy, Simple Mastectomy: This MIPS episode-based cost measure assesses costs
associated with partial or total mastectomy for breast cancer.
•
Medicare Spending Per Beneficiary {MSPB) Clinician: This MIPS cost measure applies to clinicians providing care in
inpatient hospitals, including those who treat patients within the surgical settings of general surgery, neurosurgery, and
cardiothoracic surgery.
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•
62605
Non-Emergent Coronary Artery Bypass Graft {CABG): This MIPS episode-based cost measure assesses costs
associated with CABG. This also aligns with quality measures such as Ql64: Coronary Artery Bypass Graft (CABG):
Prolonged Intubation or Ql68: Coronary Artery Bypass Graft (CABG): Surgical Re-Exploration.
Surgical Care MVP Tables
As stated in the introduction of this appendix, we considered measures and improvement activities available within the MIPS
inventory and selected those we determined best fit the clinical concept of the proposed Surgical Care MVP. We request
comment on the measures and activities included in this MVP.
Symbol Key:
Single asterisk (*): existing measures and improvement activities with proposed revisions
Double asterisk(**): measures and improvement activities only available when included in an MVP
Single exclamation point(!): high priority measures
Double exclamation point(!!): outcome measures
Tilde(-): measures and improvement activities that include a health equity component
Percent(%): attestation to IA_PCMH: Electronic submission of Patient Centered Medical Home accreditation provides full credit
for the improvement activity performance category
(*)(!) Q047: Advance Care Plan
(Collection Type: Medicare Part B Claims
Specifications, MIPS CQMs Specifications)
(~) IA_AHE_3: Promote use of PatientReported Outcome Tools
(High)
Colon and Rectal Resection
(!!) Q164: Coronary Artery Bypass Graft
(CABG): Prolonged Intubation
(Collection Type: MIPS CQMs
Specifications)
(~) IA_AHE_9: Implement Food Insecurity
and Nutrition Risk Identification and
Treatment Protocols
(Medium)
Lumbar Spine Fusion for Degenerative
Disease, 1-3 Levels
(!!) Q167: Coronary Artery Bypass Graft
(CABG): Postoperative Renal Failure
(Collection Type: MIPS CQMs
Specifications)
IA_BE_12: Use evidence-based decision aids
to support shared decision-making
(Medium)
Medicare Spending Per Beneficiary
(MSPB) Clinician
IA_CC_15: PSH Care Coordination
(High)
Non-Emergent Coronary Artery Bypass
Graft (CABG)
Q226: Preventive Care and Screening:
Tobacco Use: Screening and Cessation
Intervention
(Collection Type: Medicare Part B Claims
Specifications, eCQM Specifications, MIPS
CQMs Specifications)
Q264: Sentinel Lymph Node Biopsy for
Invasive Breast Cancer
(Collection Type: MIPS CQMs
Specifications)
(!!) Q354: Anastomotic Leak Intervention
(Collection Type: MIPS CQMs
Specifications)
(*)(!!) Q355: Unplanned Reoperation within
the 30-Day Postoperative Period
(Collection Type: MIPS CQMs
Specifications)
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(!!) Q357: Surgical Site Infection (SSI)
(Collection Type: MIPS CQMs
Specifications)
(!) Q358: Patient-Centered Surgical Risk
Assessment and Communication
(Collection Type: MIPS CQMs
Specifications)
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Lumpectomy, Partial Mastectomy, Simple
Mastectomy
IA_CC_17: Patient Navigator Program
(High)
IA_CC_18: Relationship-Centered
Communication
(Medium)
(*) IA_ERP_6: COVID-19 Vaccine
Achievement for Practice Staff
(Medium)
(**) IA_MVP: Practice-Wide Quality
Improvement in MIPS Value Pathways
(High)
(%) IA_PCMH: Electronic submission of
Patient Centered Medical Home accreditation
(~) IA_PM_ 11: Regular review practices in
place on targeted patient population needs
(Medium)
H IA_PSPA_7: Use ofQCDR data for
ongoing practice assessment and
improvements
(Medium)
IA_PSPA_8: Use of Patient Safety Tools
(Medium)
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(*)(!!) Q168: Coronary Artery Bypass Graft
(CABG): Surgical Re-Exploration
(Collection Type: MIPS CQMs
Specifications)
Femoral or Inguinal Hernia Repair
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(!!) Q445: Risk-Adjusted Operative Mortality
for Coronary Artery Bypass Graft (CABG)
(Collection Type: MIPS CQMs
Specifications)
(!!) Q459: Back Pain After Lumbar Surgery
(Collection Type: MIPS CQMs
Specifications)
(!!) Q461: Leg Pain After Lumbar Surgery
(Collection Type: MIPS CQMs
Specifications)
(!!) Q471: Functional Status After Lumbar
Surgery
(Collection Type: MIPS CQMs
Specifications)
H(!) Q487: Screening for Social Drivers of
Health
(Collection Type: MIPS CQMs
Specifications)
(!!) Q479: Hospital-Wide, 30-Day, All-Cause Unplanned
Readmission (HWR) Rate for the Merit-Based Incentive Payment
Systems (MIPS) Groups
(Collection Type: Administrative Claims)
(!!) Q484: Clinician and Clinician Group Risk-standardized Hospital
Admission Rates for Patients with Multiple Chronic Conditions
(Collection Type: Administrative Claims)
Security Risk Analysis
High Priority Practices Safety Assurance Factors for EHR Resilience
Guide (SAFER Guide)
e-Prescribing
Query of Prescription Drug Monitoring Program (PDMP)
Provide Patients Electronic Access to Their Health Information
Support Electronic Referral Loops By Sending Health Information
AND
Support Electronic Referral Loops By Receiving and Reconciling
Health Information
OR
Health Information Exchange (HIE) Bi-Directional Exchange
OR
Enabling Exchange Under the Trusted Exchange Framework and
Common Agreement (TEFCA)
Immunization Registry Reporting
Syndromic Surveillance Reporting (Optional)
Electronic Case Reporting
Public Health Registry Reporting (Optional)
Clinical Data Registry Reporting (Optional)
Actions to Limit or Restrict Compatibility or Interoperability of
CEHRT
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62607
Group B: Modifications to Previously Finalized MVPs for the CY 2025 Performance
Period/2027 MIPS Payment Year and Future Years
B.1: Adopting Best Practices and Promoting Patient Safety within Emergency Medicine
MVP
The B. l tables represent the measures and activities finalized within the Adopting Best Practices and Promoting Patient Safety
within Emergency Medicine MVP (88 FR 88029 through 80032) with modifications proposed for the CY 2025 performance
period/2027 MIPS payment year and future years. We request comment on the proposed modifications included in this MVP.
Quality Measures
We are proposing to modify the previously finalized Adopting Best Practices and Promoting Patient Safety within Emergency
Medicine MVP to remove one MIPS quality measure as it is a process measure and has become standard of care, based upon
MIPS performance data showing continued high performance.
•
Q254: Ultrasound Determination of Pregnancy Location for Pregnant Patients with Abdominal Pain
Improvement Activities
For the reasons stated in the introduction of this appendix 1023 , we are proposing the following: add the proposed modified
IA_ERP_6 to all new and previously finalized MVPs because of the importance of vaccination status in practice settings; remove
the weights associated with the improvement activities contained in this MVP; and remove one improvement activity being
proposed for removal from MIPS:
•
IA_CC_2: Implementation of improvements that contribute to more timely communication of test results
We are proposing to modify the IA_BE_4: Engagement of patients through implementation of improvements in patient portal
improvement activity, which includes a proposed activity title update. Please see Appendix 2, Improvement Activities: Table
Group B of this proposed rule for all proposed revisions to this activity.
Symbol Key:
1023
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Plus sign(+): proposed additions ofMIPS quality measures, improvement activities, or cost measures
Single asterisk(*): existing measures and improvement activities with proposed revisions
Double asterisk(**): measures and improvement activities only available when included in an MVP
Single exclamation point(!): high priority measures
Double exclamation point(!!): outcome measures
Tilde(-): measures and improvement activities that include a health equity component
Percent(%): attestation to IA_PCMH: Electronic submission of Patient Centered Medical Home accreditation provides full credit
for the improvement activity performance category
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TABLE B.la: Adopting Best Practices and Promoting Patient Safety within Emergency Medicine MVP Measures and
Im rovement Activities
(!) Q065: Appropriate Treatment for Upper
Respiratory Infection (URI)
(Collection Type: eCQM Specifications,
MIPS CQMs Specifications)
(~) IA_AHE_l2: Practice Improvements
that Engage Community Resources to
Address Drivers of Health
(High)
(!) Q 116: Avoidance of Antibiotic
Treatment for Acute Bronchitis/Bronchiolitis
(Collection Type: MIPS CQMs
Specifications)
(*) IA_BE_4: Engagement of patients
through implementation of improvements in
patient portal
(Medium)
(!) Q321: CAHPS for MIPs Clinician/Group
Survey
(Collection Type: CAHPS Survey Vendor)
IA_BE_6: Regularly Assess Patient
Experience of Care and Follow Up on
Findings
(High)
(*)(!) Q331: Adult Sinusitis: Antibiotic
Prescribed for Acute Viral Sinusitis
(Overuse)
(Collection Type: MIPS CQMs
Specifications)
(!) Q415: Emergency Medicine: Emergency
Department Utilization of CT for Minor
Blunt Head Trauma for Patients Aged 18
Years and Older
(Collection Type: MIPS CQMs
Specifications)
(!) Q416: Emergency Medicine: Emergency
Department Utilization of CT for Minor
Blunt Head Trauma for Patients Aged 2
Through 17 Years
(Collection Type: MIPS CQMs
Specifications)
(~)(!) Q487: Screening for Social Drivers of
Health
(Collection Type: MIPS CQMs
Specifications)
(!!) ACEP50: ED Median Time from ED
arrival to ED departure for all Adult Patients
(Collection Type: QCDR)
Emergency Medicine
IA_BMH_l2: Promoting Clinician WellBeing
(High)
(+)(*) IA_ERP_6: COVID-19 Vaccine
Achievement for Practice Staff
(Medium)
(**) IA_MVP: Practice-Wide Quality
Improvement in MIPS Value Pathways
(High)
(%) IA_PCMH: Electronic submission of
Patient Centered Medical Home
accreditation
IA_PSPA_l: Participation in an AHRQlisted patient safety organization
(Medium)
H IA_PSPA_7: Use ofQCDR data for
ongoing practice assessment and
improvements
(Medium)
IA_PSPA_l5: Implementation ofan
Antimicrobial Stewardship Program (ASP)
(Medium)
(!) ACEP52: Appropriate Emergency
Department Utilization of Lumbar Spine
Imaging for Atraumatic Low Back Pain
(Collection Type: QCDR)
(!) ECPR46: Avoidance of Opiates for Low
Back Pain or Migraines
(Collection Type: QCDR)
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(!) HCPR24: Appropriate Utilization of
Vancomycin for Cellulitis
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TABLE B.lb: Adopting Best Practices and Promoting Patient Safety within Emergency Medicine MVP Foundational
La
(!!) Q479: Hospital-Wide, 30-Day, All-Cause Unplanned
Readmission (HWR) Rate for the Merit-Based Incentive Payment
Systems (MIPS) Groups
(Collection Type: Administrative Claims)
(!!) Q484: Clinician and Clinician Group Risk-standardized Hospital
Admission Rates for Patients with Multiple Chronic Conditions
(Collection Type: Administrative Claims)
Security Risk Analysis
High Priority Practices Safety Assurance Factors for EHR Resilience
Guide (SAFER Guide)
e-Prescribing
Query of Prescription Drug Monitoring Program (PDMP)
Provide Patients Electronic Access to Their Health Information
Support Electronic Referral Loops By Sending Health Information
AND
Support Electronic Referral Loops By Receiving and Reconciling
Health Information
OR
Health Information Exchange (HIE) Bi-Directional Exchange
OR
Enabling Exchange Under the Trusted Exchange Framework and
Common Agreement (TEFCA)
Immunization Registry Reporting
Syndromic Surveillance Reporting (Optional)
Electronic Case Reporting
Public Health Registry Reporting (Optional)
Clinical Data Registry Reporting (Optional)
Actions to Limit or Restrict Compatibility or Interoperability of
CEHRT
ONC Direct Review Attestation
B.2: Advancing Cancer Care MVP
The B.2 tables represent the measures and activities finalized within the Advancing Cancer Care MVP (88 FR 80008 through
80011) with modifications proposed for the CY 2025 performance period/2027 MIPS payment year and future years. We request
comment on the proposed modifications included in this MVP.
Quality Measures
The following quality measures proposed within this MVP provide a meaningful and comprehensive assessment of the clinical
care for clinicians providing care to patients with cancer:
•
0102: Prostate Cancer: Avoidance of Overuse of Bone Scan for Staging Low Risk Prostate Cancer Patients: This MIPS
quality measure assesses overuse of bone scans for patients with prostate cancer with low incidence of recurrence
receiving treatment.
•
TBD: Positive PD-Ll Biomarker Expression Test Result Prior to First-Line Immune Checkpoint Inhibitor Therapy:
This proposed MIPS quality measure ensures timely biomarker testing for patients with a diagnosis of metastatic nonsmall cell lung cancer or squamous cell carcinoma of head and neck on first-line immune checkpoint inhibitor (TCI)
therapy.
•
TBD: Appropriate Germline Testing for Ovarian Cancer Patients: This proposed MIPS quality measure assesses
patients with a diagnosed with epithelial ovarian, fallopian tube, or primary peritoneal cancer for completion germ line
testing within 6 months of diagnosis.
•
TBD: Patient-Reported Pain Interference Following Chemotherapy among Adults with Breast Cancer: This proposed
MIPS quality measure assesses pain interference following chemotherapy administered with curative intent to adult
patients with breast cancer.
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We are proposing to modify the previously finalized Advancing Cancer Care MVP within the quality performance category of
this MVP to include six additional MIPS quality measures and one additional QCDR measure that address appropriate cancer
care treatment. We reviewed the MIPS quality measure inventory and considered feedback received during the 2025 MVP
maintenance period to determine which quality measures to include in this MVP.
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•
•
TBD: Patient-Reported Fatigue Following Chemotherapy among Adults with Breast Cancer: This proposed MIPS
quality measure assess fatigue following chemotherapy administered with curative intent to adult patients with breast
cancer.
TBD: Utilization of Prophylactic GCSF for Cancer Patients Receiving Low-Risk Chemotherapy /inverse measure):
The intent of this QCDR measure is to assess prophylactic use of granulocyte colony stimulating factor (G-CSF) when
it is not indicated for low-risk chemotherapy and is not restricted to metastatic colorectal cancer.
In addition, we arc proposing the following broadly applicable MIPS quality measure, which is relevant to patients receiving
cancer care and their experience of their health care treatment journey:
0495: Ambulatory Palliative Care Patients' Experience of Feeling Heard and Understood: This MIPS quality measure
•
ensures palliative care clinicians and/or teams arc actively engaged to ensure patients are understood in a significant
and empowering way.
Wc are proposing to modify the previously finalized Advancing Cancer Care MVP to remove two MIPS quality measures as they
arc duplicative in concept to current MIPS quality measures and arc being proposed for removal from MIPS:
•
Q144: Oncology: Medical and Radiation - Plan of Care for Pain
•
Q452: Patients with Metastatic Colorcctal Cancer and RAS (KRAS or NRAS) Gene Mutation Spared Treatment with
Anti-epidermal Growth Factor Receptor (EGFR) Monoclonal Antibodies
We are also proposing to remove one QCDR measure which will be replaced by TBD: Utilization of Prophylactic GCSF for
Cancer Patients Receiving Low-Risk Chemotherapy (inverse measure), which has a broader denominator and is not restricted to
metastatic colorcctal cancer.
•
PIMSH2: Oncology: Utilization ofGCSF in Metastatic Colorectal Cancer
Improvement Activities
For the reasons stated in the introduction of this appendix1°24, we are proposing the following: add the proposed modified
IA_ERP_6 to all new and previously finalized MVPs because ofthc importance of vaccination status in practice settings; and add
an additional improvement activity that addresses maintenance requests from the public, as well as addresses priority areas
including food insecurity and the incorporation of patient voices into health care decision making:
•
IA_AHE_9: Implement Food Insecurity and Nutrition Risk Identification and Treatment Protocols
For the reasons stated in the introduction of this appendix, we are proposing the following: remove the weights associated with
the improvement activities contained in this MVP; and remove three improvement activities being proposed for removal from
MIPS:
•
IA_CC_ 1: Implementation of Use of Specialist Reports Back to Referring Clinician or Group to Close Referral Loop
•
IA_EPA_I: Provide 24/7 Access to MIPS Eligible Clinicians or Groups Who Have Real-Time Access to Patient's
Medical Record
•
IA_ERP_ 4: Implementation ofa Personal Protective Equipment (PPE) Plan
We are proposing to modify the IA_BE_4: Engagement of patients through implementation of improvements in patient portal
improvement activity, which includes a proposed activity title update. Please sec Appendix 2, Improvement Activities: Table
Group B of this proposed rule for all proposed revisions to this activity.
Cost Measures
Symbol Key:
Plus sign (+ ): proposed additions of MIPS quality measures, improvement activities, or cost measures
Carat symbol(''): new proposed measures and improvement activities
Single asterisk(*): existing measures and improvement activities with proposed revisions
Double asterisk(**): measures and improvement activities only available when included in an MVP
Single exclamation point(!): high priority measures
Double exclamation point(!!): outcome measures
1024 Sec MVP Development: Improvement Activity Policy Update and Global Inclusion ofan Improvement Activity
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We arc proposing to add one MIPS cost measure within the cost performance category of this MVP, which applies to the clinical
topic of cancer care. We reviewed the MIPS cost measure inventory and considered feedback received from interested parties
through the MVP maintenance process to determine the cost measures to include in this MVP. The following cost measure
provides a meaningful assessment of the clinical care for clinicians who specialize in cancer care and aligns with other measures
and activities included within this MVP:
•
Prostate Cancer: This proposed MIPS episode-based cost measure would assess costs associated with prostate cancer.
This also aligns with quality measures such as Q102: Prostate Cancer: Avoidance of Overuse of Bone Scan for Staging
Low Risk Prostate Cancer Patients. We note that this is a new cost measure we are proposing to adopt as described in
section IV.A.4.e.(2)(a)(iii)ofthis proposed rule.
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62611
Tilde(-): measures and improvement activities that include a health equity component
Percent(%): attestation to IA_pCMH: Electronic submission of Patient Centered Medical Home accreditation provides full credit
for the improvement activity performance category
(*)(!) Q047: Advance Care Plan
(Collection Type: Medicare Part B Claims
Measure Specifications, MIPS CQMs
Specifications)
(+)(-) IA_AHE_9: Implement Food
Insecurity and Nutrition Risk Identification
and Treatment Protocols
(Medium)
(+)(!) Q102: Prostate Cancer: Avoidance of
Overuse of Bone Scan for Staging Low Risk
Prostate Cancer Patients
(Collection Type: eCQM Specifications,
MIPS CQMs Specifications)
(*) IA_BE_4: Engagement of patients
through implementation of improvements in
patient portal
(Medium)
Q134: Preventive Care and Screening:
Screening for Depression and Follow-Up
Plan
(Collection Type: Medicare Part B Claims
Measure Specifications, eCQM
Specifications, MIPS CQMs Specifications)
(*)(!) Q143: Oncology: Medical and
Radiation - Pain Intensity Quantified
(Collection Type: eCQM Specifications,
MIPS CQMs Specifications)
(!) Q321: CAHPS for MIPS Clinician/Group
Survey
(Collection Type: CAHPS Survey Vendor)
(*)(!) Q450: Appropriate Treatment for
Patients with Stage I (Tlc)-III HER2
Positive Breast Cancer
(Collection Type: MIPS CQMs
Specifications)
(*) Q451: RAS (KRAS and NRAS) Gene
Mutation Testing Performed for Patients
with Metastatic Colorectal Cancer who
receive Anti-epidermal Growth Factor
Receptor (EGFR) Monoclonal Antibody
Therapy
(Collection Type: MIPS CQMs
Specifications)
IA_BE_6: Regularly Assess Patient
Experience of Care and Follow Up on
Findings
(High)
IA_BE_15: Engagement of patients, family
and caregivers in developing a plan of care
(Medium)
IA_BE_24: Financial Navigation Program
(Medium)
IA_BMll_12: Promoting Clinician WellBeing
(High)
IA_CC_13: Practice Improvements to align
with OpenNotes principles
(Medium)
IA_CC_l 7: Patient Navigator Program
(High)
IA_EPA_2: Use oftelehealth services that
expand practice access
(Medium)
(+)(*) IA_ERP_6: COVID-19 Vaccine
Achievement for Practice Staff
(Medium)
(**) IA_MVP: Practice-Wide Quality
Improvement in MIPS Value Pathways
(High)
(%) IA_PCMII: Electronic submission of
Patient Centered Medical Home
accreditation
(!) Q457: Percentage of Patients Who Died
from Cancer Admitted to Hospice for Less
than 3 days (lower score - better)
(Collection Type: MIPS CQMs
Specifications)
H IA_PM_14: Implementation of
methodologies for improvements in
longitudinal care management for high risk
patients
(Medium)
(*) Q462: Bone Density Evaluation for
Patients with Prostate Cancer and Receiving
Androgen Deprivation Therapy
(Collection Type: eCQM Specifications)
IA_PM_ 15: Implementation of episodic
care management practice improvements
(Medium)
(~)(!) Q487: Screening for Social Drivers of
Health
(Collection Type: MIPS CQMs
Specifications)
Total Per Capita Cost (TPCC)
IA_PM_l6: Implementation of medication
management practice improvements
(Medium)
IA_PM_21: Advance Care Planning
(Medium)
(*) Q490: Appropriate Intervention of
Immune-related Diarrhea and/or Colitis in
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(!) Q453: Percentage of Patients Who Died
from Cancer Receiving Systemic CancerDirected Therapy in the Last 14 Days of Life
(lower score - better)
(Collection Type: MIPS CQMs
Specifications)
(A)(+) Prostate Cancer
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Patients Treated with Immune Checkpoint
Inhibitors
(Collection Type: MIPS CQMs
Specifications)
(+)(!!) Q495: Ambulatory Palliative Care
Patients' Experience of Feeling Heard and
Understood
(Collection Type: MIPS CQMs
Specifications)
(*)(!!) Q503: Gains in Patient Activation
Measure (PAM®) Scores at 12 Months
(Collection Type: MIPS CQMs
Specifications)
IA_PSPA_13: Participation in Joint
Commission Evaluation Initiative
(Medium)
IA_PSPA_16: Use decision supportideally platform-agnostic, interoperable
clinical decision support (CDS) tools -and
standardized treatment protocols to manage
workflow on the care team to meet patient
needs
(Medium)
IA_PSPA_28: Completion ofan Accredited
Safety or Quality Improvement Program
(Medium)
(+)(A)(!) TBD: Positive PD-LI Biomarker
Expression Test Result Prior to First-Line
Immune Checkpoint Inhibitor Therapy
(Collection Type: MIPS CQMs
Specifications)
(+)(A) TBD: Appropriate Germline Testing
for Ovarian Cancer Patients
(Collection Type: MIPS CQMs
Specifications)
(+)(A)(!!) TBD: Patient-Reported Pain
Interference Following Chemotherapy
among Adults with Breast Cancer
(Collection Type: MIPS CQMs
Specifications)
(+)(A)(!!) TBD: Patient-Reported Fatigue
Following Chemotherapy among Adults
with Breast Cancer
(Collection Type: MIPS CQMs
Specifications)
(!) PIMSH13: Oncology: Mutation testing
for Stage TV Lung Cancer Completed Prior
to start of Targeted Therapy
(Collection Type: QCDR)
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(+)(!) TBD: Utilization of Prophylactic
GCSF for Cancer Patients Receiving LowRisk Chemotherapy (inverse measure)
(Collection Type: QCDR)
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TABLE B.2b: Adopting Best Practices and Promoting Patient Safety within Emergency Medicine MVP Foundational
La er
(!!) Q479: Hospital-Wide, 30-Day, All-Cause Unplanned
Readmission (HWR) Rate for the Merit-Based Incentive Payment
Systems (MIPS) Groups
(Collection Type: Administrative Claims)
(!!) Q484: Clinician and Clinician Group Risk-standardized Hospital
Admission Rates for Patients with Multiple Chronic Conditions
(Collection Type: Administrative Claims)
Security Risk Analysis
High Priority Practices Safety Assurance Factors for EHR Resilience
Guide (SAFER Guide)
e-Prescribing
Query of Prescription Drug Monitoring Program (POMP)
Provide Patients Electronic Access to Their Health Information
Support Electronic Referral Loops By Sending Health Information
AND
Support Electronic Referral Loops By Receiving and Reconciling
Health Infonnation
OR
Health Information Exchange (HIE) Bi-Directional Exchange
OR
Enabling Exchange Under the Trusted Exchange Framework and
Common Agreement (TEFCA)
Immunization Registry Reporting
Syndromic Surveillance Reporting (Optional)
Electronic Case Reporting
Public Health Registry Reporting (Optional)
Clinical Data Registry Reporting (Optional)
Actions to Limit or Restrict Compatibility or Interoperability of
CEHRT
ONC Direct Review Attestation
B.3: Advancing Care for Heart Disease MVP
The B.3 tables represent the measures and activities finalized within the Advancing Care for Heart Disease MVP (88 FR 80022
through 80025) with modifications proposed for the CY 2025 perfonnance period/2027 MIPS payment year and future years. We
request comment on the proposed modifications included in this MVP.
Quality Measures
We are proposing to modify the previously finalized Advancing Care for Heart Disease MVP within the quality performance
category of this MVP to include one additional broadly applicable MIPS quality measure relevant to patients receiving care for
heart disease. We reviewed the quality measure inventory and considered feedback received during the 2025 MVP maintenance
period to determine which quality measures to include in this MVP.
•
0495: Ambulatory Palliative Care Patients' Experience of Feeling Heard and Understood: This MIPS quality measure
ensures palliative care clinicians and/or teams empathize to ensure patients are understood in a significant and
empowering way.
Improvement Activities
For the reasons stated in the introduction of this appendix 1025, we are proposing the following: add the proposed modified
IA_ERP_6 to all new and previously finalized MVPs because of the importance of vaccination status in practice settings; and
remove the weights associated with the improvement activities contained in this MVP.
1025 See MVP Development Improvement Activity Policy Update and Global Inclusion ofan Improvement Activity
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We are not proposing to modify the MIPS cost measures included within the cost performance category of this previously
finalized Advancing Care for Heart Disease MVP by proposing to add or remove cost measures from the MVP.
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However, we are proposing to modify the ST-Elevation Myocardial Infarction (STEM!) with Percutaneous Coronary
Intervention (PCI) cost measure, which includes a proposed measure title update. Please see section IV.A.4.e.(2)(a)(vii) of this
proposed rule for all proposed revisions to this cost measure.
Symbol Key:
Plus sign (+ ): proposed additions of MIPS quality measures, improvement activities, or cost measures
Single asterisk(*): existing measures and improvement activities with proposed revisions
Double asterisk(**): measures and improvement activities only available when included in an MVP
Single exclamation point(!): high priority measures
Double exclamation point(!!): outcome measures
Tilde(~): measures and improvement activities that include a health equity component
Percent(%): attestation to IA_PCMH: Electronic submission of Patient Centered Medical Home accreditation provides full credit
for the improvement activity performance category
Converting Enzyme (ACE) Inhibitor or
Angiotensin Receptor Blocker (ARB) or
Angiotensin Receptor-Neprilysin Inhibitor
(ARNI) Therapy for Left Ventricular
Systolic Dysfunction (LVSD)
(Collection Type: eCQM Specifications,
MIPS CQMs Specifications)
Q006: Coronary Artery Disease (CAD):
Antiplatelet Therapy
(Collection Type: MIPS CQMs
Specifications)
Q007: Coronary Artery Disease (CAD):
Beta-Blocker Therapy- Prior Myocardial
Infarction (MI) or Left Ventricular Systolic
Dysfunction (LVEF :;:: 40%)
(Collection Type: eCQM Specifications,
MIPS CQMs Specifications)
Q008: Heart Failure (HF): Beta-Blocker
Therapy for Left Ventricular Systolic
Dysfunction (L VSD)
(Collection Type: eCQM Specifications,
MIPS CQMs Specifications)
(*)(!) Q047: Advance Care Plan
(Collection Type: Medicare Part B Claims
Measure Specifications, MIPS CQMs
Specifications)
Q118: Coronary Artery Disease (CAD):
Angiotensin-Converting Enzyme (ACE)
Inhibitor or Angiotensin Receptor Blocker
(ARB) Therapy - Diabetes or Left
Ventricular Systolic Dysfunction (L VEF
:;::40%)
(Collection Type: MIPS CQMs
Specifications)
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(**) Qt 28: Preventive Care and Screening:
Body Mass Index (BM!) Screening and
Follow-Up Plan
(Collection Type: Medicare Part B Claims
Measure Specifications, eCQM
Specifications, MIPS CQMs Specifications)
Q134: Preventive Care and Screening:
Screening for Depression and Follow-Up
Plan
(Collection Type: Medicare Part B Claims
Measure Specifications, eCQM
S ecifications, MIPS CQMs S cifications
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H IA_AHE_9: Implement Food Insecurity
and Nutrition Risk Identification and
Treatment Protocols
(Medium)
Elective Outpatient Percutaneous
Coronary Intervention (PCI)
H IA_AHE_12: Practice Improvements
that Engage Community Resources to
Address Drivers of Health
(High)
(*) ST-Elevation Myocardial Infarction
(STEMI) with Percutaneous Coronary
Intervention (PCI)
IA_BE_6: Regularly Assess Patient
Experience of Care and Follow Up on
Findings
(High)
Heart Failure
Medicare Spending Per Beneficiary
(MSPB) Clinician
Total Per Capita Cost (TPCC)
IA_BE_12: Use evidence-based decision
aids to support shared decision-making
(Medium)
IA_BE_l5: Engagement of patients, family
and caregivers in developing a plan of care
(Medium)
IA_BE_24: Financial Navigation Program
(Medium)
IA_BE_25: Drug Cost Transparency
(High)
(~) IA_CC_9: Implementation of
practices/processes for developing regular
individual care plans
(Medium)
(+)(*) IA_ERP_6: COVID-19 Vaccine
Achievement for Practice Staff
(Medium)
(**) IA_MVP: Practice-Wide Quality
Improvement in MIPS Value Pathways
(High)
(%) IA_PCMH: Electronic submission of
Patient Centered Medical Home
accreditation
IA_PM_ 13: Chronic care and preventative
care management for empaneled patients
(Medium)
(~) IA_PM_l4: Implementation of
methodologies for improvements in
longitudinal care management for high-risk
atients
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QOOS: Heart Failure (HF): Angiotensin-
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62615
(Medium)
(*)(!) Q238: Use of High-Risk Medications
in Older Adults
(Collection Type: eCQM Specifications,
MIPS CQMs Specifications)
IA_pSPA_4: Administration of the AHRQ
Survey of Patient Safety Culture
(Medium)
(!) Q243: Cardiac Rehabilitation Patient
Referral from an Outpatient Setting
(Collection Type: MIPS CQMs
Specifications)
(-) IA_PSPA_7: Use ofQCDR data for
ongoing practice assessment and
improvements
(Medium)
Q326: Atrial Fibrillation and Atrial Flutter:
Chronic Anticoagulation Therapy
(Collection Type: MIPS CQMs
Specifications)
(!) Q377: Functional Status Assessments for
Heart Failure
(Collection Type: eCQM Specifications)
(!!) Q392: Cardiac Tamponade and/or
Pericardiocentesis Following Atrial
Fibrillation Ablation
(Collection Type: MIPS CQMs
Specifications)
(*)(!!) Q393: Infection within 180 Days of
Cardiac Implantable Electronic Device
(CIED) Implantation, Replacement, or
Revision
(Collection Type: MIPS CQMs
Specifications)
(!!) Q441: Ischemic Vascular Disease (IVD)
All or None Outcome Measure (Optimal
Control)
(Collection Type: MIPS CQMs
Specifications)
(-)(!) Q487: Screening for Social Drivers of
Health
(Collection Type: MIPS CQMs
Specifications)
(*)(!!) Q492: Risk-Standardized Acute
Cardiovascular-Related Hospital Admission
Rates for Patients with Heart Failure under
the Merit-based Incentive Payment System
(Collection Type: Administrative Claims)
(+)(!!) Q495: Ambulatory Palliative Care
Patients' Experience of Feeling Heard and
Understood
(Collection Type: MIPS CQMs
Specifications)
(*)(!!) Q503: Gains in Patient Activation
Measure (PAM®) Scores at 12 Months
(Collection Type: MIPS CQMs
S ecifications)
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TABLE 8.3b: Advancing Care for Heart Disease MVP Foundational Layer
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(!!) Q479: Hospital-Wide, 30-Day, All-Cause Unplanned
Readmission (HWR) Rate for the Merit-Based Incentive Payment
Systems (MIPS) Groups
(Collection Type: Administrative Claims)
(!!) Q484: Clinician and Clinician Group Risk-standardized Hospital
Admission Rates for Patients with Multiple Chronic Conditions
(Collection Type: Administrative Claims)
Security Risk Analysis
High Priority Practices Safety Assurance Factors for EHR Resilience
Guide (SAFER Guide)
e-Prescribing
Query of Prescription Drug Monitoring Program (POMP)
Provide Patients Electronic Access to Their Health Information
Support Electronic Referral Loops By Sending Health Information
AND
Support Electronic Referral Loops By Receiving and Reconciling
Health Information
OR
Health Information Exchange (HIE) Bi-Directional Exchange
OR
Enabling Exchange Under the Trusted Exchange Framework and
Common Agreement (TEFCA)
Immunization Registry Reporting
Syndromic Surveillance Reporting (Optional)
Electronic Case Reporting
Public Health Registry Reporting (Optional)
Clinical Data Registry Reporting (Optional)
Actions to Limit or Restrict Compatibility or Interoperability of
CEHRT
ONC Direct Review Attestation
B.4: Advancing Rheumatology Patient Care MVP
The B.4 tables represent the measures and activities finalized within the Advancing Rheumatology Patient Care MVP (88 FR
80026 through 80029) with modifications proposed for the CY 2025 performance period/2027 MIPS payment year and future
years. We request comment on the proposed modifications included in this MVP.
Quality Measures
We are proposing to modify the previously finalized Advancing Rheumatology Patient Care MVP within the quality performance
category of this MVP to include one additional MIPS quality measure and two QCDR measures that are relevant to patients
receiving rheumatology care. We reviewed the MIPS quality measure inventory and considered feedback received during the
2025 MVP maintenance period to determine which quality measures to include in this MVP.
The following quality measures proposed within this MVP provide address appropriate clinical care for patients with
rheumatological conditions:
•
0039: Screening for Osteoporosis for Women Aged 65-85 Years of Age: This MIPS quality measure assesses women
who have ever received a dual-energy x-ray absorptiometry (DXA) test to evaluate for the disease osteoporosis.
•
UREOA2: Ankylosing Spondylitis: Appropriate Pharmacologic Therapy: This QCDR measure assesses patients newly
diagnosed with ankylosing spondylitis for appropriate pharmacologic therapy by ensuring a course ofNSAIDs is
prescribed before initiation of biologics during the first six months of treatment.
•
UREOA9: Screening for Osteoporosis for Men Aged 70 Years and Older: This QCDR measure identifies male patients
who have ever had a central dual-energy X-ray absorptiometry (DXA) to screen for osteoporosis to identify
osteoporotic risk for fracture.
For the reasons stated in the introduction of this appendix 1026, we are proposing the following: add the proposed modified
IA_ERP_6 to all new and previously finalized MVPs because of the importance of vaccination status in practice settings; remove
1026
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Improvement Activities
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62617
the weights associated with the improvement activities contained in this MVP; and remove one improvement activities being
proposed for removal from MIPS:
•
IA_EPA_1: Provide 24/7 Access to MIPS Eligible Clinicians or Groups Who Have Real-Time Access to Patient's
Medical Record
We are proposing to modify the IA_BE_4: Engagement of patients through implementation of improvements in patient portal
improvement activity, which includes a proposed activity title update. Please see Appendix 2, Improvement Activities: Table
Group B ofthis proposed rule for all proposed revisions to this activity.
Cost Measures
We are proposing to add one MIPS cost measure within the cost performance category of this MVP, which applies to the clinical
topic ofrheumatology care. We reviewed the MIPS cost measure inventory and considered feedback received from interested
parties through the MVP maintenance process to determine the cost measures to include in this MVP. The following cost
measure provides a meaningful assessment of the clinical care for clinicians who specialize in rheumatology care and aligns with
the other measures and activities included within this MVP:
•
Rheumatoid Arthritis: This proposed MIPS episode-based cost measure would assess costs associated with medical
care to manage and treat rheumatoid arthritis. This also aligns with quality measures such as Ql 77: Rheumatoid
Arthritis (RA): Periodic Assessment of Disease Activity or Q 178: Rheumatoid Arthritis (RA): Functional Status
Assessment. We note that this is a new cost measure we are proposing to adopt as described in section IV.A.4.e.(2)(a)
(iii) of this proposed rule.
Symbol Key:
Plus sign(+): proposed additions ofMIPS quality measures, improvement activities, or cost measures
Carat symbol("): new proposed measures and improvement activities
Single asterisk(*): existing measures and improvement activities with proposed revisions
Double asterisk(**): measures and improvement activities only available when included in an MVP
Single exclamation point(!): high priority measures
Double exclamation point(!!): outcome measures
Tilde(-): measures and improvement activities that include a health equity component
Percent(%): attestation to IA_PCMH: Electronic submission of Patient Centered Medical Home accreditation provides full credit
for the improvement activity performance category
(*)(!) QlJO: Documentation of Current
Medications in the Medical Record
(Collection Type: eCQM Specifications,
MIPS CQMs Specifications)
Q134: Preventive Care and Screening:
Screening for Depression and Follow-Up
Plan
(Collection Type: Medicare Part B Claims
Measure Specifications, eCQM
Specifications, MIPS CQMs Specifications)
(*) Qt 76: Tuberculosis Screening Prior to
First Course of Biologic and/or Immune
Response Modifier Therapy
(Collection Type: MIPS CQMs
Specifications)
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(*) Ql 77: Rheumatoid Arthritis (RA):
Periodic Assessment of Disease Activity
(Collection Type: MIPS CQMs
Specifications)
(*) Q178: Rheumatoid Arthritis (RA):
Functional Status Assessment
(Collection Type: MIPS CQMs
Specifications)
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(~) IA_AHE_J: Promote use of PatientReported Outcome Tools
(High)
(")(+) Rheumatoid Arthritis
Total Per Capita Cost (TPCC)
H IA_BE_l: Use of certified EHR to
capture patient reported outcomes
(Medium)
(*) IA_BE_4: Engagement of patients
through implementation of improvements in
patient portal
(Medium)
IA_ BE_6: Regularly Assess Patient
Experience of Care and Follow Up on
Findings
(High)
IA_BE_l5: Engagementofpatients, family
and caregivers in developing a plan of care
(Medium)
L~_BE_24: Financial Navigation Program
(Medium)
IA_BE_25: Drug Cost Transparency
(High)
IA_BMH_2: Tobacco use
(Medium)
IA_EPA_2: Use oftelehealth services that
expand practice access
(Medium
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(+) Q039: Screening for Osteoporosis for
Women Aged 65-85 Years of Age
(Collection Type: Medicare Part B Claims
Measure Specifications, MIPS CQMs
Specification)
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(*) Q180: Rheumatoid Arthritis (RA):
Glucocorticoid Management
(Collection Type: MIPS CQMs
Specifications)
(~)(!) Q487: Screening for Social Drivers of
Health
(Collection Type: MIPS CQMs
Specifications)
(+)(*) IA_ERP_6: COVID-19 Vaccine
Achievement for Practice Staff
(Medium)
(**) IA_MVP: Practice-Wide Quality
Improvement in MIPS Value Pathways
(High)
(%) IA_PCMH: Electronic submission of
Patient Centered Medical Home
accreditation
(*) Q493: Adult Immunization Status
(Collection Type: MIPS CQMs
Specifications)
(*)(!!) Q503: Gains in Patient Activation
Measure (PAM®) Scores at 12 Months
(Collection Type: MIPS CQMs
Specifications)
ACR12: Disease Activity Measurements for
Patients with PsA
(Collection Type: QCDR)
IA_PM_l6: Implementation of medication
management practice improvements
(Medium)
IA_PSPA_28: Completion ofan Accredited
Safety or Quality Improvement Program
(Medium)
(!!) ACR14: Gout Serum Urate Target
(Collection Type: QCDR)
(!) ACR15: Safe Hydroxychloroquine
Dosing
(Collection Type: QCDR)
(+)(!) lJREQA2: Ankylosing Spondylitis:
Appropriate Pharmacologic Therapy
(Collection Type: QCDR)
(+) UREQA9: Screening for Osteoporosis
for Men Aged 70 Years and Older
(Collection Type: QCDR)
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(!!) UREQAIO: Ankylosing Spondylitis:
Controlled Disease Or Improved Disease
Function
Collection T e: QCDR)
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(!!) Q479: Hospital-Wide, 30-Day, All-Cause Unplanned
Readmission (HWR) Rate for the Merit-Based Incentive Payment
Systems (MIPS) Groups
(Collection Type: Administrative Claims)
(!!) Q484: Clinician and Clinician Group Risk-standardized Hospital
Admission Rates for Patients with Multiple Chronic Conditions
(Collection Type: Administrative Claims)
62619
Security Risk Analysis
High Priority Practices Safety Assurance Factors for EHR Resilience
Guide (SAFER Guide)
e-Prescribing
Query of Prescription Drug Monitoring Program (PDMP)
Provide Patients Electronic Access to Their Health Information
Support Electronic Referral Loops By Sending Health Information
AND
Support Electronic Referral Loops By Receiving and Reconciling
Health Information
OR
Health Information Exchange (HIE) Bi-Directional Exchange
OR
Enabling Exchange Under the Trusted Exchange Framework and
Common Agreement (TEFCA)
Immunization Registry Reporting
Syndromic Surveillance Reporting (Optional)
Electronic Case Reporting
Public Health Registry Reporting (Optional)
Clinical Data Registry Reporting (Optional)
Actions to Limit or Restrict Compatibility or Interoperability of
CEHRT
ONC Direct Review Attestation
B.5: Coordinating Stroke Care to Promote Prevention and Cultivate Positive Outcomes
MVP
The B.5 tables represent the measures and activities finalized within the Coordinating Stroke Care to Promote Prevention and
Cultivate Positive Outcomes MVP (88 FR 80039 through 80041) with modifications proposed for the CY 2025 performance
period/2027 MIPS payment year and future years. We request comment on the proposed modifications included in this MVP.
Quality Measures
We are proposing to modify the previously finalized Coordinating Stroke Care to Promote Prevention and Cultivate Positive
Outcomes MVP to include one additional broadly applicable MIPS quality measure relevant to patients receiving stroke care and
their experience of their health care treatment journey. We reviewed the MIPS quality measure inventory and considered
feedback received during the 2025 MVP maintenance period to determine which quality measures to include in this MVP.
0495: Ambulatory Palliative Care Patients' Experience of Feeling Heard and Underntood: This MIPS quality measure
•
ensures palliative care clinicians and/or teams empathize to ensure patients are understood in a significant and
empowering way.
We are also proposing to modify the previously finalized Coordinating Stroke Care to Promote Prevention and Cultivate Positive
Outcomes MVP to remove one MIPS quality measure as this measure is proposed for removal from MIPS:
•
Q409: Clinical Outcome Post Endovascular Stroke Treatment
Improvement Activities
For the reasons stated in the introduction of this appendix 1027, we arc proposing the following: add the proposed modified
IA_ERP_6 to all new and previously finalized MVPs because of the importance of vaccination status in practice settings; remove
1027 Sec MVP Development Improvement Activity Policv Update and Global Inclusion ofan Improvement Activity
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We are proposing to modify the Q344: Rate of Carotid Artery Stenting (CAS) for Asymptomatic Patients, Without Major
Complications (Discharged to Home by Post-Operative Day #2) quality measure, which includes a proposed measure title update.
Please see Appendix l: MIPS Quality Measures, Table Group D of this proposed rule for all proposed revisions to this measure.
62620
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the weights associated with the improvement activities contained in this MVP; and remove one improvement activity being
proposed for removal from MIPS:
•
IA_CC_2: Implementation of improvements that contribute to more timely communication of test results
We are proposing to modify the IA_BE_4: Engagement of patients through implementation of improvements in patient portal
improvement activity, which includes a proposed activity title update. Please see Appendix 2, Improvement Activities: Table
Group B of this proposed rule for all proposed revisions to this activity.
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Symbol Key:
Plus sign (+ ): proposed additions of MIPS quality measures, improvement activities, or cost measures
Single asterisk(*): existing measures and improvement activities with proposed revisions
Double asterisk(**): measures and improvement activities only available when included in an MVP
Single exclamation point (!): high priority measures
Double exclamation point(!!): outcome measures
Tilde (-): measures and improvement activities that include a health equity component
Percent(%): attestation to IA_PCMH: Electronic submission of Patient Centered Medical Home accreditation provides full credit
for the improvement activity performance category
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62621
TABLE 8.5a: Coordinating Stroke Care to Promote Prevention and Cultivate Positive Outcomes MVP Measures and
Im rovement Activities
(*)(!) Q047: Advance Care Plan
(Collection Type: Medicare Part B Claims
Measure Specifications, MIPS CQMs
Specifications)
(~) IA_AHE_9: Implement Food Insecurity
and Nutrition Risk Identification and
Treatment Protocols
(Medium)
Q187: Stroke and Stroke Rehabilitation:
Thrombolytic Therapy
(Collection Type: MIPS CQMs
Specifications)
(-) IA_BE_l: Use ofcertified EHR to
capture patient reported outcomes
(Medium)
Q326: Atrial Fibrillation and Atrial Flutter:
Chronic Anticoagulation Therapy
(Collection Type: MIPS CQMs
Specifications)
(*)(!!) Q344: Rate of Carotid Artery
Stenting (CAS) for Asymptomatic Patients,
Without Major Complications (Discharged
to Home by Post-Operative Day #2)
(Collection Type: MIPS CQMs
Specifications)
(*)(! !) Q413: Door to Puncture Time for
Endovascular Stroke Treatment
(Collection Type: MIPS CQMs
Specifications)
Q438: Slatin Therapy for the Prevention and
Treatment of Cardiovascular Disease
(Collection Type: eCQM Specifications,
MIPS CQMs Specifications)
(!!) Q441: Ischemic Vascular Disease (IVD)
All or None Outcome Measure (Optimal
Control)
(Collection Type: MIPS CQMs
Specifications)
(-)(!) Q487: Screening for Social Drivers of
Health
(Collection Type: MIPS CQMs
Specifications)
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(+)(!!) Q495: Ambulatory Palliative Care
Patients' Experience of Feeling Heard and
Understood
(Collection Type: MIPS CQMs
S ecifications
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(*) IA_BE_4: Engagement of patients
through implementation of improvements in
patient portal
(Medium)
IA_BE_6: Regularly Assess Patient
Experience of Care and Follow Up on
Findings
(High)
IA_BE_24: Financial Navigation Program
(Medium)
(-) IA_BMH_15: Behavioral/Mental Health
and Substance Use Screening and Referral
for Older Adults
(High)
IA_CC_lJ: Practice improvements to align
with OpenNotes principles
(Medium)
IA_CC_l 7: Patient Navigator Program
(High)
(+)(*) IA_ERP_6: COVTD-19 Vaccine
Achievement for Practice Staff
(Medium)
(**) IA_MVP: Practice-Wide Quality
Improvement in MIPS Value Pathways
(High)
(%) IA_PCMH: Electronic submission of
Patient Centered Medical Home
accreditation
IA_PM_IJ: Chronic care and preventative
care management for empaneled patients
(Medium)
IA_PM_l5: Implementation of episodic
care management practice improvements
(Medium)
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(*)(!!) Q236: Controlling High Blood
Pressure
(Collection Type: Medicare Part B Claims
Measure Specifications, eCQM
Specifications, MIPS CQMs Specifications)
lntracraniaI Hemorrhage or Cerebral
Infarction
62622
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TABLE B.Sb: Coordinating Stroke Care to Promote Prevention and Cultivate Positive Outcomes MVP Foundational
La er
(!!) Q479: Hospital-Wide, 30-Day, All-Cause Unplanned
Readmission (HWR) Rate for the Merit-Based Incentive Payment
Systems (MIPS) Groups
(Collection Type: Administrative Claims)
(!!) Q484: Clinician and Clinician Group Risk-standardized Hospital
Admission Rates for Patients with Multiple Chronic Conditions
(Collection Type: Administrative Claims)
Security Risk Analysis
High Priority Practices Safety Assurance Factors for EHR Resilience
Guide (SAFER Guide)
e-Prescribing
Query of Prescription Drug Monitoring Program (POMP)
Provide Patients Electronic Access to Their Health Information
Support Electronic Referral Loops By Sending Health Information
AND
Support Electronic Referral Loops By Receiving and Reconciling
Health Information
OR
Health Information Exchange (HIE) Bi-Directional Exchange
OR
Enabling Exchange Under the Trusted Exchange Framework and
Common Agreement (TEFCA)
Immunization Registry Reporting
Syndromic Surveillance Reporting (Optional)
Electronic Case Reporting
Public Health Registry Reporting (Optional)
Clinical Data Registry Reporting (Optional)
Actions to Limit or Restrict Compatibility or Interoperability of
CEHRT
ONC Direct Review Attestation
B.6: Focusing on Women's Health MVP
The B.6 tables represent the measures and activities finalized within the Focusing on Women's Health MVP (88 FR 79981
through 79986) with modifications proposed for the CY 2025 performance period/2027 MIPS payment year and future years. We
request comment on the proposed modifications included in this MVP.
Quality Measures
We are proposing to modify the previously finalized Focusing on Women's Health MVP within the quality performance category
of this MVP to include to include one additional MIPS quality measure that is relevant to women's health. We reviewed the
MWS quality measure inventory and considered feedback received during the 2025 MVP maintenance period to determine which
quality measures to include in this MVP.
The following quality measure proposed within this MVP provides a meaningful and comprehensive assessment of the clinical
care for clinicians providing women's health care to patients:
•
0039: Screening for Osteoporosis for Women Aged 65-85 Years of Age: This MWS quality measure assesses women
who have ever received a dual-energy x-ray absorptiometry (DXA) test to evaluate for the disease osteoporosis.
We are proposing to modify the Q432: Proportion of Patients Sustaining a Bladder Injury at the Time of any Pelvic Organ
Prolapse Repair quality measure, which includes a proposed measure title update. Please see Appendix 1: MIPS Quality
Measures, Table Group D of this proposed rule for all proposed revisions to this measure.
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We are also proposing to modify the previously fmalized Focusing on Women's Health MVP to remove one MIPS quality
measure as it is a process measure that has become standard of care, based on MIPS performance data as demonstrated by the
measure's high performance in the PY2024 MIPS Historical Quality Benchmarks file, as well as previous year's benchmark data,
and is being proposed for removal from MIPS:
•
Q472: Appropriate Use ofDXA Scans in Women Under 65 Years Who Do Not Meet the Risk Factor Profile for
Osteoporotic Fracture
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62623
Improvement Activities
For the reasons stated in the introduction of this appendix1028, we are proposing the following: add the modified proposed
IA_ERP_6 to all new and previously finalized MVPs because of the importance of vaccination status in practice settings; and
remove the weights associated with the improvement activities contained in this MVP.
We are proposing to modify the IA_BE_4: Engagement of patients through implementation of improvements in patient portal
improvement activity, which includes a proposed activity title update. Please see Appendix 2, Improvement Activities: Table
Group B of this proposed rule for all proposed revisions to this activity.
Symbol Key:
Plus sign(+): proposed additions of MIPS quality measures, improvement activities, or cost measures
Single asterisk(*): existing measures and improvement activities with proposed revisions
Double asterisk(**): measures and improvement activities only available when included in an MVP
Single exclamation point(!): high priority measures
Double exclamation point(!!): outcome measures
Tilde(-): measures and improvement activities that include a health equity component
Percent(%): attestation to IA_PCMH: Electronic submission of Patient Centered Medical Home accreditation provides full credit
for the improvement activity performance category
(+) Q039: Screening for Osteoporosis for
Women Aged 65-85 Years of Age
(Collection Type: Medicare Part B Claims
Measure Specifications, MIPS CQMs
Specification)
Q048: Urinary Incontinence: Assessment of
Presence or Absence of Urinary Incontinence in
Women Aged 65 Years and Older
(Collection Type: MIPS CQMs Specifications)
(*)(**) Q112: Breast Cancer Screening
(Collection Type: Medicare Part B Claims
Measure Specifications, eCQM Specifications,
MIPS CQMs Specification)
Q134: Preventive Care and Screening:
Screening for Depression and Follow-Up Plan
(Collection Type: Medicare Part B Claims
Measure Specifications, eCQM Specifications,
MIPS CQMs Specification)
Total Per Capita Cost (TPCC)
(~) IA_AHE_9: Implement Food Insecurity
and Nutrition Risk Identification and
Treatment Protocols
(Medium)
(~) IA_AHE_12: Practice Improvements that
Engage Community Resources to Address
Drivers of Health
(High)
(*) IA_BE_4: Engagement of patients through
implementation of improvements in patient
portal
(Medium)
(~) IA_BE_16: Promote Self-management in
Usual Care
(Medium)
Q309: Cervical Cancer Screening
(Collection Type: eCQM Specifications)
(~) IA_BMH_ll: Implementation ofa
Trauma-Informed Care (TIC) Approach to
Clinical Practice
(Medium)
(!!) Q335: Maternity Care: Elective Delivery
(Without Medical Indication) at< 39 Weeks
(Overuse)
(Collection Type: MIPS CQMs Specifications)
(*)(!) Q336: Maternity Care: Postpartum
Follow-up and Care Coordination
(Collection Type: MIPS CQMs Specifications)
Q400: One-Time Screening for Hepatitis C
Virus HCV) and Treatment Initiation
Medicare Spending Per Beneficiary
(MSPB) Clinician
(~) IA_AHE_3: Promote use of PatientReported Outcome Tools
(High)
Q226: Preventive Care and Screening: Tobacco
Use: Screening and Cessation Intervention
(Collection Type: Medicare Part B Claims
Measure Specifications, eCQM Specifications,
MIPS CQMs Specification)
Q310: Chlamydia Screening in Women
(Collection Type: eCQM Specifications)
(~) IA_BMH_14: Behavioral/Mental Health
and Substance Use Screening and Referral for
Pregnant and Postpartum Women
(High)
(~) IA_CC_9: Implementation of
practices/processes for developing regular
individual care plans
(Medium)
L\_EPA_2: Use oftelehealth services that
expand practice access
Medium)
1028 See MVP Development: Improvement Activitv Policy Update and Global Inclusion of an Improvement Activitv
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(~) IA_AHE_l: Enhance Engagement of
Medicaid and Other Underserved Populations
(High)
62624
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
(Collection Type: MIPS CQMs Specifications)
(!) Q422: Performing Cystoscopy at the Time
of Hysterectomy for Pelvic Organ
Prolapse to Detect Lower Urinary
Tract Injury
(Collection Type: Medicare Part B Claims
Measure Specifications, MIPS CQMs
Specifications)
Q43 I: Preventive Care and Screening:
Unhealthy Alcohol Use: Screening & Brief
Counseling
(Collection Type: MIPS CQMs Specifications)
(*)(!!) Q432: Proportion of Patients Sustaining
a Bladder Injury at the Time of any Pelvic
Organ Prolapse Repair
(Collection Type: MIPS CQMs Specifications)
(*)(!) Q448: Appropriate Workup Prior to
Endometrial Ablation
(Collection Type: MIPS CQMs Specifications)
(+)(*) IA_ERP_6: COVID-19 Vaccine
Achievement for Practice Staff
(Medium)
(**) IA_MVP: Practice-Wide Quality
Improvement in MIPS Value Pathways
(High)
(%) IA_PCMH: Electronic submission of
Patient Centered Medical Home accreditation
(-) IA_PM_6: Use oftoolsets or other
resources to close healthcare disparities across
communities
(Medium)
H TA_PM_23: Use of Computable
Guidelines and Clinical Decision Support to
Improve Adherence for Cervical Cancer
Screening and Management Guidelines
(High)
Q475: HIV Screening
(Collection Type: eCQM Specifications)
H(!) Q487: Screening for Social Drivers of
Health
(Collection Type: MIPS CQMs Specifications)
(*) Q493: Adult Immunization Status
(Collection Type: MIPS CQMs Specifications)
Q496: Cardiovascular Disease (CVD) Risk
Assessment Measure - Proportion of
Pregnant/Postpartum Patients that Receive
CVD Risk Assessment with a Standardized
Instrument
(Collection Type: MIPS CQMs Specifications)
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(!!) UREQAS: Vitamin D level: Effective
Control of Low Bone Mass/Osteopenia and
Osteoporosis: Therapeutic Level Of25 OH
Vitamin D Level Achieved
(Collection Type: QCDR)
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
(!!) Q479: Hospital-Wide, 30-Day, All-Cause Unplanned
Readmission (HWR) Rate for the Merit-Based Incentive
Payment Systems (MIPS) Groups
(Collection Type: Administrative Claims)
(!!) Q484: Clinician and Clinician Group Risk-standardized
Hospital Admission Rates for Patients with Multiple Chronic
Conditions
(Collection Type: Administrative Claims)
62625
Security Risk Analysis
High Priority Practices Safety Assurance Factors for EHR Resilience Guide
(SAFER Guide)
e-Prescribing
Query of Prescription Drug Monitoring Program (PDMP)
Provide Patients Electronic Access to Their Health Information
Support Electronic Referral Loops By Sending Health Information
AND
Support Electronic Referral Loops By Receiving and Reconciling Health
Information
OR
Health Information Exchange (HIE) Bi-Directional Exchange
OR
Enabling Exchange Under the Trusted Exchange Framework and Common
Agreement (TEFCA)
Immunization Registry Reporting
Syndromic Surveillance Reporting (Optional)
Electronic Case Reporting
Public Health Registry Reporting (Optional)
Clinical Data Registry Reporting (Optional)
Actions to Limit or Restrict Compatibility or Interoperability ofCEHRT
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62626
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B.7: Improving Care for Lower Extremity Joint Repair MVP
The B. 7 tables represent the measures and activities finalized within the Improving Care for Lower Extremity Joint Repair MVP
(88 FR 80033 through 80035) with modifications proposed for the CY 2025 performance period/2027 MIPS payment year and
future years. We request comment on the proposed modifications included in this MVP.
Improvement Activities
For the reasons stated in the introduction of this appcndix1029, we are proposing the following: add the proposed modified
IA_ERP_6 to all new and previously finalized MVPs because of the importance of vaccination status in practice settings; and add
an additional improvement activity that addresses maintenance requests from the public, as well as addresses priority areas
including food insecurity and the incorporation of patient voices into health care decision making:
•
IA_AHE_9: Implement Food Insecurity and Nutrition Risk Identification and Treatment Protocols
In addition, we are proposing the following: remove the weights associated with the improvement activities contained in this
MVP; and remove one improvement activity being proposed for removal from MIPS:
•
1A_PSPA_27: Invasive Procedure or Surgery Anticoagulation Medication Management
1029 See MVP Development: Improvement Activity Policy Update and Global Inclusion of an Improvement Activity
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Symbol Key:
Plus sign(+): proposed additions of MIPS quality measures, improvement activities, or cost measures
Single asterisk(*): existing measures and improvement activities with proposed revisions
Double asterisk(**): measures and improvement activities only available when included in an MVP
Single exclamation point(!): high priority measures
Double exclamation point(!!): outcome measures
Tilde(-): measures and improvement activities that include a health equity component
Percent(%): attestation to IA_PCMH: Electronic submission of Patient Centered Medical Home accreditation provides full credit
for the improvement activity performance category
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
(!) Q024: Communication with the
Physician or Other Clinician Managing OnGoing Care Post-Fracture for Men and
Women Aged 50 Years and Older
(Collection Type: Medicare Part B Claims
Measure Specifications, MIPS CQMs
Specifications)
(**) Q128: Preventive Care and Screening:
Body Mass Index (BMI) Screening and
Follow-Up Plan
(Collection Type: Medicare Part B Claims
Measure Specifications, eCQM
Specifications, MIPS CQMs Specifications)
(!) Q350: Total Knee or Hip Replacement:
Shared Decision-Making: Trial of
Conservative (Non-surgical) Therapy
(Collection Type: MIPS CQMs
Specifications)
(-) IA_AHE_3: Promote use of PatientReported Outcome Tools
(High)
IA BE 12 Use evidence-based decision
aids to support shared decision-making
(Medium)
IA_CC_7: Regular training in care
coordination
(Medium)
(*)(!) Q376: Functional Status Assessment
for Total Hip Replacement
(Collection Type: eCQM Specifications)
IA_ CC_ 13: Practice improvements to align
with OpenNotes principles
(Medium)
(*)(!!) Q470: Functional Status After
Primary Total Knee Replacement
(Collection Type: MIPS CQMs
Specifications)
IA_CC_15: PSH Care Coordination
(High)
Health
(Collection Type: MIPS CQMs
Specifications)
Knee Arthroplasty
IA_BE_6: Regularly Assess Patient
Experience of Care and Follow Up on
Findings
(High)
(-) IA_CC_9: Implementation of
practices/processes for developing regular
individual care plans
(Medium)
(-)(!) Q487: Screening for Social Drivers of
Elective Primary Hip Arthropiasty
(+)(-) IA_AHE_9: Implement Food
Insecurity and Nutrition Risk Identification
and Treatment Protocols (Medium Weight)
(Medium)
(!) Q351: Total Knee or Hip Replacement:
Venous Thromboembolic and
Cardiovascular Risk Evaluation
(Collection Type: MIPS CQMs
Specifications)
(!!) Q480: Risk-standardized complication
rate (RSCR) following elective primary total
hip arthroplasty (THA) and/or total knee
arthroplasty (TKA) for Merit-based
Incentive Payment System (MIPS)
(Collection Type: Administrative Claims)
62627
(+)(*) IA_ERP_6: COVTD-19 Vaccine
Achievement for Practice Staff
(Medium)
(**) IA_MVP: Practice-Wide Quality
Improvement in MIPS Value Pathways
(High)
(%) IA_PCMH: Electronic submission of
Patient Centered Medical Home
accreditation
H IA_PSPA_7: Use ofQCDR data for
ongoing practice assessment and
improvements
(Medium)
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(-) IA_PSPA_18: Measurement and
improvement at the practice and panel level
Medium)
62628
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
(!!) Q479: Hospital-Wide, 30-Day, All-Cause Unplanned
Readmission (HWR) Rate for the Merit-Based Incentive Payment
Systems (MIPS) Groups
(Collection Type: Administrative Claims)
(!!) Q484: Clinician and Clinician Group Risk-standardized Hospital
Admission Rates for Patients with Multiple Chronic Conditions
(Collection Type: Administrative Claims)
Security Risk Analysis
High Priority Practices Safety Assurance Factors for EHR Resilience
Guide (SAFER Guide)
e-Prescribing
Query of Prescription Drug Monitoring Program (POMP)
Provide Patients Electronic Access to Their Health Information
Support Electronic Referral Loops By Sending Health Information
AND
Support Electronic Referral Loops By Receiving and Reconciling
Health Information
OR
Health Information Exchange (HIE) Bi-Directional Exchange
OR
Enabling Exchange Under the Trusted Exchange Framework and
Common Agreement (TEFCA)
Immunization Registry Reporting
Syndromic Surveillance Reporting (Optional)
Electronic Case Reporting
Public Health Registry Reporting (Optional)
Clinical Data Registry Reporting (Optional)
Actions to Limit or Restrict Compatibility or Interoperability of
CEHRT
ONC Direct Review Attestation
B.8: Optimal Care for Kidney Health MVP
The B.8 tables represent the measures and activities finalized within the Optimal Care for Kidney Health MVP (88 FR 80012
through 80015) with modifications proposed for the CY 2025 performance period/2027 MIPS payment year and future years. We
request comment on the proposed modifications included in this MVP.
Quality Measures
We are proposing to modify the Q00l: Diabetes: Hemoglobin Ale (HbAlc) Poor Control (>9%) quality measure, which includes
a proposed measure title update. Please see Appendix 1: MIPS Quality Measures, Table Group D of this proposed rule for all
proposed revisions to this measure.
Improvement Activities
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We are proposing to modify the previously finalized Optimal Care for Kidney Health MVP within the quality performance
category of this MVP to include three additional broadly applicable MIPS quality measures that are relevant to patients receiving
care for kidney health. We reviewed the quality measure inventory and considered feedback received during the 2025 MVP
maintenance period to determine which quality measures to include in this MVP.
•
0495: Ambulatory Palliative Care Patients' Experience of Feeling Heard and Understood: This MIPS quality measure
ensures palliative care clinicians and/or teams empathize to ensure patients are understood in a significant and
empowering way.
•
TBD: First Year Standardized Waitlist Ratio (FYSWR): This MIPS quality measure measures number of incident
(newly initiated on dialysis) patients in a practitioner (inclusive of physicians and advanced practice providers) groups
who were listed on the kidney or kidney-pancreas transplant waitlist or received a living donor transplant within the
first year of initiating dialysis.
•
TBD: Percentage of Prevalent Patients Waitlisted (PPPW) and Percentage of Prevalent Patients Waitlisted in Active
Status {aPPPW): This MIPS quality measure tracks dialysis patients who at a practitioner group practice who were on
the kidney or kidney-pancreas transplant waitlist (all patients or patients in active status).
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62629
For the reasons stated in the introduction of this appendix1030, we are proposing the following: add the proposed modified
IA_ERP_6 to all new and previously finalized MVPs because of the importance of vaccination status in practice settings; remove
the weights associated with the improvement activities contained in this MVP; and remove one improvement activity being
proposed for removal from MIPS:
•
IA_CC_2: Implementation of improvements that contribute to more timely communication oftest results
We are proposing to modify the IA_BE_4: Engagement of patients through implementation of improvements in patient portal
improvement activity, which includes a proposed activity title update. Please see Appendix 2, Improvement Activities: Table
Group B of this proposed rule for all proposed revisions to this activity.
Cost Measures
We are proposing to add three MIPS cost measures within the cost performance category of this MVP, which apply to the clinical
topic of kidney health. We reviewed the MIPS cost measure inventory and considered feedback received from interested parties
through the MVP maintenance process to determine the cost measures to include in this MVP. The following proposed new cost
measures provide a meaningful assessment of the clinical care for clinicians who specialize in kidney care and align with the
other measures and activities included within this MVP and are described in section IV.A.4.e(2)(a)(iii) of this proposed rule:
•
Chronic Kidney Disease (CKD): This proposed MIPS episode-based cost measure would assess costs associated with
medical care to manage and treat stage 4 or 5 chronic kidney disease.
•
End-Stage Renal Disease 9%)
(Collection Type: Medicare Part B Claims
Measure Specifications, eCQM
Specifications, MIPS CQMs Specifications)
(*)(!) Q047: Advance Care Plan
(Collection Type: Medicare Part B Claims
Measure Specifications, MIPS CQMs
Specifications)
(*)(!) QtJO: Documentation of Current
Medications in the Medical Record
(Collection Type: eCQM Specifications,
MIPS CQMs Specifications)
(*)(!!) Q236: Controlling High Blood
Pressure
(Collection Type: Medicare Part B Claims
Measure Specifications, eCQM
Specifications, MIPS CQMs Specifications)
Acute Kidney Injury Requiring New
Inpatient Dialysis (AKI)
(A)(+) Chronic Kidney Disease (CKD)
H
IA_AHE_9: Implement Food Insecurity
and Nutrition Risk Identification and
Treatment Protocols
(Medium)
(*) IA_BE_4: Engagementofpatients
through implementation of improvements in
patient portal
(Medium)
(A)(+) End-Stage Renal Disease (ESRD)
(A)(+) Kidney Transplant Management
Total Per Capita Cost (TPCC)
IA_BE_6: Regularly Assess Patient
Experience of Care and Follow Up on
Findings
(High)
(~) IA_BE_l4: Engage Patients and
Families to Guide Improvement in the
System of Care
(High)
IA_ BE_ 15: Engagement of patients, finni!y
and caregivers in developing a plan of care
(Medium)
(~)(!) Q487: Screening for Social Drivers of
Health
1030 Sec MVP Development: Improvement Activity Policy Update and Global Inclusion ofan Improvement Activity
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(!!) Q482: Hemodia!ysis Vascular Access:
Practitioner Level Long-term Catheter Rate
(Collection Type: MIPS CQMs
Specifications)
(~) IA_AHE_3: Promote use of PatientReported Outcome Tools
(High)
62630
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(~) IA_BE_16: Promote Self-management
in Usual Care
(Medium)
(Collection Type: MIPS CQMs
Specifications)
(*) Q488: Kidney Health Evaluation
(Collection Type: eCQM Specifications,
MIPS CQMs Specifications)
Q489: Adult Kidney Disease: Angiotensin
Converting Enzyme (ACE) Inhibitor or
Angiotensin Receptor Blocker (ARB)
Therapy
(Collection Type: MIPS CQMs
Specifications)
(*) Q493: Adult Immunization Status
(Collection Type: MIPS CQMs
Specifications)
(+)(!!) Q495: Ambulatory Palliative Care
Patients' Experience of Feeling Heard and
Understood
(Collection Type: MIPS CQMs
Specifications)
(*)(!!) Q503: Gains in Patient Activation
Measure (PAM®) Scores at 12 Months
(Collection Type: MIPS CQMs
Specifications)
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(**) IA_MVP: Practice-Wide Quality
Improvement in MIPS Value Pathways
(High)
(%) IA_PCMH: Electronic submission of
Patient Centered Medical Home
accreditation
(-) IA_PM_11: Regular review practices in
place on targeted patient population needs
(Medium)
IA_PM_13: Chronic care and preventative
care management for empaneled patients
(Medium)
PO 00000
IA_PSPA_l6: Use decision supportideally platform-agnostic, interoperable
clinical decision support (CDS) tools -and
standardized treatment protocols to manage
workflow on the care team to meet patient
needs
(Medium)
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(+)(") TBD: Percentage of Prevalent
Patients Waitlisted (PPPW) and Percentage
of Prevalent Patients Waitlisted in Active
Status (aPPPW)
(Collection Type: MIPS CQMs
Specifications)
20:32 Jul 30, 2024
(+)(*) IA_ERP_6: COVID-19 Vaccine
Achievement for Practice Staff
(Medium)
IA_PM_t6: Implementation of medication
management practice improvements
(Medium)
(+)(") TBD: First Year Standardized
Waitlist Ratio (FYSWR)
(Collection Type: MIPS CQMs
Specifications)
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IA_CC_13: Practice improvements to align
with OpenNotes principles
(Medium)
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(!!) Q479: Hospital-Wide, 30-Day, All-Cause Unplanned
Readmission (HWR) Rate for the Merit-Based Incentive Payment
Systems (MIPS) Groups
(Collection Type: Administrative Claims)
Security Risk Analysis
(!!) Q484: Clinician and Clinician Group Risk-standardized Hospital
Admission Rates for Patients with Multiple Chronic Conditions
(Collection Type: Administrative Claims)
e-Prescribing
62631
High Priority Practices Safety Assurance Factors for EHR
Resilience Guide (SAFER Guide)
Query of Prescription Drug Monitoring Program (POMP)
Provide Patients Electronic Access to Their Health Information
Support Electronic Referral Loops By Sending Health Information
AND
Support Electronic Referral Loops By Receiving and Reconciling
Health Information
OR
Health Information Exchange (HIE) Bi-Directional Exchange
OR
Enabling Exchange Under the Trusted Exchange Framework and
Common Agreement (TEFCA)
Immunization Registry Reporting
Syndromic Surveillance Reporting (Optional)
Electronic Case Reporting
Public Health Registry Reporting (Optional)
Clinical Data Registry Reporting (Optional)
Actions to Limit or Restrict Compatibility or Interoperability of
CEHRT
ONC Direct Review Attestation
B.9: Patient Safety and Support of Positive Experiences with Anesthesia MVP
The B.9 tables represent the measures and activities finalized within the Patient Safety and Support of Positive Experiences with
Anesthesia MVP (88 FR 80036 through 80038) with modifications proposed for the CY 2025 performance period/2027 MIPS
payment year and future years. We request comment on the proposed modifications included in this MVP.
Improvement Activities
For the reasons stated in the introduction of this appendix 103 1, we are proposing the following: add the proposed modified
IA_ERP_6 to all new and previously finalized MVPs because of the importance of vaccination status in practice settings; remove
the weights associated with the improvement activities contained in this MVP; and remove two improvement activities being
proposed for removal from MIPS:
•
IA_CC_2: Implementation of improvements that contribute to more timely communication oftest results
•
IA_EPA_ 1: Provide 24/7 Access to MIPS Eligible Clinicians or Groups Who Have Real-Time Access to Patient's
Medical Record
TABLE B.9a: Patient Safety and Support of Positive Experiences with Anesthesia MVP Measures and Improvement
Activities
1031 See MVP Development: Improvement Activity Policv Update and Global Inclusion ofan Improvement Activity
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Symbol Key:
Plus sign(+): proposed additions of MIPS quality measures, improvement activities, or cost measures
Single asterisk(*): existing measures and improvement activities with proposed revisions
Double asterisk(**): measures and improvement activities only available when included in an MVP
Single exclamation point(!): high priority measures
Double exclamation point(!!): outcome measures
Tilde ( ~): measures and improvement activities that include a health equity component
Percent(%): attestation to IA_PCMH: Electronic submission of Patient Centered Medical Home accreditation provides full credit
for the improvement activity performance category
62632
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(!!) Q404: Anesthesiology Smoking
Abstinence
(Collection Type: MIPS CQMs
Specifications)
IA_BE_6: Regularly Assess Patient
Experience of Care and Follow Up on
Findings
(High)
(!!) Q424: Perioperative Temperature
Management
(Collection Type: MIPS CQMs
Specifications)
IA_BE_22: Improved practices that engage
patients pre-visit
(Medium)
(!) Q463: Prevention of Post-Operative
Vomiting (POV)- Combination Therapy
(Pediatrics)
(Collection Type: MIPS CQMs
Specifications)
(!) Q477: Multimodal Pain Management
(Collection Type: MIPS CQMs
Specifications)
(-)(!) Q487: Screening for Social Drivers of
Health
(Collection Type: MIPS CQMs
Specifications)
(!) ABG44: Low Flow Inhalational General
Anesthesia
(Collection Type: QCDR)
(!!) AQI48: Patient-Reported Experience
with Anesthesia
(Collection Type: QCDR)
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(!!) EPREOPJI: lntraoperative
Hypotension (TOH) among Non-Emergent
Noncardiac Surgical Cases
(Collection Type: QCDR)
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IA_BMH_2: Tobacco use
(Medium)
IA_CC_l5: PSH Care Coordination
(High)
IA_CC_l9: Tracking of clinician's
relationship to and responsibility for a
patient by reporting MACRA patient
relationship codes
(High)
(+)(*) IA_ERP_6: COVID-19 Vaccine
Achievement for Practice Staff
(Medium)
(**) IA_MVP: Practice-Wide Quality
Improvement in MIPS Value Pathways
(High)
(%) IA_PCMH: Electronic submission of
Patient Centered Medical Home
accreditation
IA_PSPA_l: Participation in an AHRQlisted patient safety organization
(Medium)
H IA_PSPA_7: Use ofQCDR data for
ongoing practice assessment and
improvements
(Medium)
IA_PSPA_l6: Use decision supportideally platform-agnostic, interoperable
clinical decision support (CDS) tools -and
standardized treatment protocols to manage
workflow on the care team to meet patient
needs
Medium
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(!) Q430: Prevention of Post-Operative
Nausea and Vomiting (PONV)Combination Therapy
(Collection Type: MIPS CQMs
Specifications)
Medicare Spending Per Beneficiary
(MSPB) Clinician
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(!!) Q479: Hospital-Wide, 30-Day, All-Cause Unplanned
Readmission (HWR) Rate for the Merit-Based Incentive Payment
Systems (MIPS) Groups
(Collection Type: Administrative Claims)
(!!) Q484: Clinician and Clinician Group Risk-standardized Hospital
Admission Rates for Patients with Multiple Chronic Conditions
(Collection Type: Administrative Claims)
62633
Security Risk Analysis
High Priority Practices Safety Assurance Factors for EHR Resilience
Guide (SAFER Guide)
e-Prescribing
Query of Prescription Drug Monitoring Program (PDMP)
Provide Patients Electronic Access to Their Health Information
Support Electronic Referral Loops By Sending Health Information
AND
Support Electronic Referral Loops By Receiving and Reconciling
Health Information
OR
Health Information Exchange (HIE) Bi-Directional Exchange
OR
Enabling Exchange Under the Trusted Exchange Framework and
Common Agreement (TEFCA)
Immunization Registry Reporting
Syndromic Surveillance Reporting (Optional)
Electronic Case Reporting
Public Health Registry Reporting (Optional)
Clinical Data Registry Reporting (Optional)
Actions to Limit or Restrict Compatibility or Interoperability of
CEHRT
ONC Direct Review Attestation
B.10: Prevention and Treatment oflnfectious Disorders Including Hepatitis C and mv
MVP
The B. l 0 tables represent the measures and activities finalized within the Prevention and Treatment of Infectious Disorders
Including Hepatitis C and HIV MVP (88 FR 79991 through 79995) with modifications proposed for the CY 2025 performance
period/2027 MIPS payment year and future years. We request comment on the proposed modifications included in this MVP.
Quality Measures
We are not proposing to modify the previously finalized Prevention and Treatment oflnfcctious Disorders Including Hepatitis C
and HIV MVP within the quality performance category of this MVP by proposing to add or remove quality measures from the
MVP. However, we are proposing to modify the Q340: HIV Medical Visit Frequency quality measure, which includes a
proposed measure title update. Please see Appendix l: MIPS Quality Measures, Table Group D of this proposed rule for all
proposed revisions to this measure.
Improvement Activities
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For the reasons stated in the introduction of this appendix 1032, we are proposing the following: add the proposed modified
IA_ERP_6 to all new and previously finalized MVPs because of the importance of vaccination status in practice settings; remove
the weights associated with the improvement activities contained in this MVP; and remove one improvement activity being
proposed for removal from MIPS:
•
IA_EPA_l: Provide 24/7 Access to MIPS Eligible Clinicians or Groups who Have Real-Time Access to Patient's
Medical Record
We are proposing to modify the IA_BE_4: Engagement of patients through implementation of improvements in patient portal
improvement activity, which includes a proposed activity title update. Please see Appendix 2, Improvement Activities: Table
Group B of this proposed rule for all proposed revisions to this activity.
62634
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Symbol Key:
Plus sign(+): proposed additions of MIPS quality measures, improvement activities, or cost measures
Single asterisk(*): existing measures and improvement activities with proposed revisions
Double asterisk(**): measures and improvement activities only available when included in an MVP
Single exclamation point(!): high priority measures
Double exclamation point(!!): outcome measures
Tilde(-): measures and improvement activities that include a health equity component
Percent(%): attestation to IA_PCMH: Electronic submission of Patient Centered Medical Home accreditation provides full credit
for the improvement activity performance category
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62635
TABLE B.10a: Prevention and Treatment oflnfectious Disorders Including Hepatitis C and HIV MVP Measures and
Im rovement Activities
(!) Q065: Appropriate Treatment for Upper
Respiratory Infection (URI)
(Collection Type: eCQM Specifications,
MIPS CQMs Specifications)
(~) IA_AHE_l: Enhance Engagement of
Medicaid and Other Underserved
Populations
(High)
(*)(!) Q130: Documentation of Current
Medications in the Medical Record
(Collection Type: eCQM Specifications,
MIPS CQMs Specification)
(~) IA_AHE_S: MIPS Eligible Clinician
Leadership in Clinical Trials or CBPR
(Medium)
Q134: Preventive Care and Screening:
Screening for Depression and Follow-Up
Plan
(Collection Type: Medicare Part B Claims
Measure Specifications, eCQM
Specifications, MIPS CQMs Specification)
Q205: Sexually Transmitted Infection (STI)
Testing for People with HIV
(Collection Type: eCQM Specifications,
MIPS CQMs Specifications)
Q240: Childhood Immunization Status
(Collection Type: eCQM Specifications)
QJlO: Chlamydia Screening in Women
(Collection Type: eCQM Specifications)
(!!) Q338: HIV Viral Suppression
(Collection Type: eCQM Specifications,
MIPS CQMs Specifications)
(*)(!) Q340: HIV Medical Visit Frequency
(Collection Type: MIPS CQMs
Specifications)
Q387: Annual Hepatitis C Virus (HCV)
Screening for Patients who are Active
Injection Drug Users
(Collection Type: MIPS CQMs
Specifications)
Q400: One-Time Screening for Hepatitis C
Virus (HCV) and Treatment Initiation
(Collection Type: MIPS CQMs
Specifications)
Q401: Hepatitis C: Screening for
Hepatocellular Carcinoma (HCC) in Patients
with Cirrhosis
(Collection Type: MIPS CQMs
Specifications)
Q475: HIV Screening
(Collection Type: eCQM Specifications)
(*) Q493: Adult Immunization Status
(Collection Type: MIPS CQMs
S ecifications
(~) IA_AHE_12: Practice Improvements
that Engage Community Resources to
Address Drivers of Health
(High)
(*) IA_BE_4: Engagement of patients
through implementation of improvements in
patient portal
(Medium)
IA_BE_15: Engagement of patients, family
and caregivers in developing a plan of care
(Medium)
(+)(*) IA_ERP_6: COVID-19 Vaccine
Achievement for Practice Staff
(Medium)
(**) IA_MVP: Practice-Wide Quality
Improvement in MIPS Value Pathways
(High)
(%) IA_PCMII: Electronic submission of
Patient Centered Medical Home
accreditation
(~) IA_PM_6: Use oftoolsets or other
resources to close healthcare disparities
across communities
(Medium)
(~) IA_PM_t 1: Regular review practices in
place on targeted patient population needs
(Medium)
(~) IA_PM_14: Implementation of
methodologies for improvements in
longitudinal care management for high risk
patients
(Medium)
H IA_PM_22: Improving Practice
Capacity for Human Immunodeficiency
Virus (HIV) Prevention Services
(Medium)
IA_PSPA_23: Completion of CDC Training
on Antibiotic Stewardship
(High)
IA_PSPA_32: Use of CDC Guideline for
Clinical Decision Support to Prescribe
Opioids for Chronic Pain via Clinical
Decision Support
i h
TABLE B.lOb: Prevention and Treatment of Infectious Disorders Including Hepatitis C and HIV MVP Foundational
Layer
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(~)(!) Q487: Screening for Social Drivers of
Health
(Collection Type: MIPS CQMs
Specifications)
Total Per Capita Cost (TPCC)
62636
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(!!) Q479: Hospital-Wide, 30-Day, All-Cause Unplanned
Readmission (HWR) Rate for the Merit-Based Incentive Payment
Systems (MIPS) Groups
(Collection Type: Administrative Claims)
(!!) Q484: Clinician and Clinician Group Risk-standardized Hospital
Admission Rates for Patients with Multiple Chronic Conditions
(Collection Type: Administrative Claims)
Security Risk Analysis
High Priority Practices Safety Assurance Factors for EHR Resilience
Guide (SAFER Guide)
e-Prescribing
Query of Prescription Drug Monitoring Program (POMP)
Provide Patients Electronic Access to Their Health Information
Support Electronic Referral Loops By Sending Health Information
AND
Support Electronic Referral Loops By Receiving and Reconciling
Health Information
OR
Health Information Exchange (HIE) Bi-Directional Exchange
OR
Enabling Exchange Under the Trusted Exchange Framework and
Common Agreement (TEFCA)
Immunization Registry Reporting
Syndromic Surveillance Reporting (Optional)
Electronic Case Reporting
Public Health Registry Reporting (Optional)
Clinical Data Registry Reporting (Optional)
Actions to Limit or Restrict Compatibility or Interoperability of
CEHRT
ONC Direct Review Attestation
B.11: Quality Care for Patients with Neurological Conditions MVP
We are proposing to modify the previously finalized Optimal Care for Patients with Episodic Neurological Conditions and the
Supportive Care for Neurodegenerative Conditions MVPs into a single consolidated neurological MVP titled Quality Care for
Patient~ with Neurological Conditions. This modification is being proposed because the QCDR measures previously included
will no longer be available for use within both of the previously finalized MVPs. As such, due to the removal of these specialty
specific QCDR measures we believe the Episodic Neurological Conditions MVP no longer provides a meaningful representation
of the care provided by the clinicians identified for reporting this MVP. Therefore, we are proposing to combine the previously
finalized MVPs to ensure the availability of a robust and meaningful MVP capturing a broad scope of care provided by
neurologists. The 8.11 tables represent the measures and activities finalized within the Optimal Care for Patients with Episodic
Neurological Conditions MVP (88 FR 80015 through 80018) and the Supportive Care for Neurodegenerative Conditions MVP
(88 FR 80019 through 80021) with modifications proposed for the CY 2025 performance period/2027 MIPS payment year and
future years. We request comment on the proposed modifications included in this MVP.
We are proposing to modify the previously finalized neurology MVPs within the quality performance category of this MVP to
include two additional broadly applicable MIPS quality measures relevant to patients receiving care for neurodegenerative
disorders. We reviewed the MIPS quality measure inventory and considered feedback received during the 2024 MVP
maintenance period to determine which quality measures to include in this MVP.
•
0155: Falls: Plan of care: This MIPS quality measure ensures adult patients, with a history of falls, have a plan of care
for falls.
0495: Ambulatory Palliative Care Patients' Experience of Feeling Heard and Understood: This MIPS quality measure
•
ensures palliative care clinicians and/or teams empathize to ensure patients are understood in a significant and
empowering way.
We are proposing to modify the previously finalized MVPs to remove six QCDR measures no longer being supported by Axon
Registry QCDR:
•
AAN5: Treatment Prescribed for Acute Migraine Attack
•
AAN9: Querying and Follow-Up About Symptoms of Autonomic Dysfunction for Patients with Parkinson's Disease
•
AAN22: Quality of Life Outcome for Patients with Neurologic Conditions
•
AAN3 l: Acute Treatment Prescribed for Cluster Headache
•
AAN32: Preventive Treatment Prescribed for Cluster Headache
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•
62637
AAN34: Patient reported falls and plan of care
Improvement Activities
For the reasons stated in the introduction of this appendix 1033 , we are proposing the following: add the proposed modified
IA_ERP_6 to all new and previously finalized MVPs because of the importance of vaccination status in practice settings; remove
the weights associated with the improvement activities contained in this MVP; and remove three improvement activities being
proposed for removal from MIPS:
•
IA_BMH_8: Electronic Health Record Enhancements for BH data capture
•
IA_CC_1: Implementation of Use of Specialist Reports Back to Referring Clinician or Group to Close Referral Loop
•
IA_EPA_ I : Provide 24/7 Access to MIPS Eligible Clinicians or Groups Who Have Real-Time Access to Patient's
Medical Record
We are proposing to modify the IA_BE_4: Engagement of patients through implementation of improvements in patient portal
improvement activity, which includes a proposed activity title update. Please see Appendix 2, Improvement Activities: Table
Group B of this proposed rule for all proposed revisions to this activity.
Symbol Key:
Plus sign(+): proposed additions of MIPS quality measures, improvement activities, or cost measures
Single asterisk(*): existing measures and improvement activities with proposed revisions
Double asterisk(**): measures and improvement activities only available when included in an MVP
Single exclamation point(!): high priority measures
Double exclamation point(!!): outcome measures
Tilde (-): measures and improvement activities that include a health equity component
Percent(%): attestation to IA_PCMH: Electronic submission of Patient Centered Medical Home accreditation provides full credit
for the improvement activity performance category
(*)(!) Q047: Advance Care Plan
(Collection Type: Medicare Part B Claims
Measure Specifications, MIPS CQMs
Specifications)
(*)(!) Q130: Documentation of Current
Medications in the Medical Record
(Collection Type: eCQM Specifications,
MIPS CQMs Specifications)
(+)(*)(!) Q155: Falls: Plan of Care
(Collection Type: Medicare Part B Claims
Measure Specifications, MIPS CQMs
Specifications)
(*)(!) Q238: Use of High-Risk Medications
in Older Adults
(Collection Type: eCQM Specifications,
MIPS CQMs Specifications)
Q268: Epilepsy: Counseling for Women of
Childbearing Potential with Epilepsy
(Collection Type: MIPS CQMs
Specifications)
(*) Q281: Dementia: Cognitive Assessment
(Collection Type: eCQM Specifications)
(*)(!) Q286: Dementia: Safety Concern
Screening and Follow-Up for Patients with
Dementia
(Collection Type: MIPS CQMs
S ecifications)
Medicare Spending Per Beneficiary
(MSPB) Clinician
(*) IA_BE_4: Engagement of patients
through implementation of improvements in
patient portal
(Medium)
IA_BE_6: Regularly Assess Patient
Experience of Care and Follow Up on
Findings
(High)
(~) IA_BE_16: Promote Self-management
in Usual Care
(Medium)
IA_BE_24: Financial Navigation Program
(Medium)
IA_BMH_4: Depression screening
(Medium)
IA_EPA_2: Use oftelehealth services that
expand practice access
(Medium)
(+)(*) IA_ERP_6: COVID-19 Vaccine
Achievement for Practice Staff
(Medium)
(**) IA_MVP: Practice-Wide Quality
Improvement in MIPS Value Pathways
(High)
1033 See MVP Development Improvement Activity Policy Update and Global Inclusion of an Improvement Activity
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(*) Q282: Dementia: Functional Status
Assessment
(Collection Type: MIPS CQMs
Specifications)
(~) IA_AHE_3: Promote use of PatientReported Outcome Tools
(High)
62638
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
(*)(!) Q288: Dementia: Education and
Support of Caregivers for Patients with
Dementia
(Collection Type: MIPS CQMs
Specifications)
(*) Q290: Assessment of Mood Disorders
and Psychosis for Patients with Parkinson's
Disease
(Collection Type: MIPS CQMs
Specifications)
(*) Q291: Assessment of Cognitive
Impairment or Dysfunction for Patients with
Parkinson's Disease
(Collection Type: MIPS CQMs
Specifications)
(%) IA_PCMH: Electronic submission of
Patient Centered Medical Home
accreditation
(-) IA_PM_l 1: Regular review practices in
place on targeted patient population needs
(Medium)
IA_PM_l6: Implementation of medication
management practice improvements
(Medium)
IA_PM_21: Advance Care Planning
(Medium)
IA_PSPA_21: Implementation of fall
screening and assessment programs
(Medium)
(*)(!) Q293: Rehabilitative Therapy Referral
for Patients with Parkinson's Disease
(Collection Type: MIPS CQMs
Specifications)
(*)(!) Q386: Amyotrophic Lateral Sclerosis
(ALS) Patient Care Preferences
(Collection Type: MIPS CQMs
Specifications)
(!) Q419: Overuse of Imaging for the
Evaluation of Primary Headache
(Collection Type: MIPS CQMs
Specifications)
(~)(!) Q487: Screening for Social Drivers of
Health
(Collection Type: MIPS CQMs
Specifications)
(+)(!!) Q495: Ambulatory Palliative Care
Patients' Experience of Feeling Heard and
Understood
(Collection Type: MIPS CQMs
Specifications)
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(*)(!!) Q503: Gains in Patient Activation
Measure (PAM®) Scores at 12 Months
(Collection Type: MIPS CQMs
S ecifications)
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(!!) Q479: Hospital-Wide, 30-Day, All-Cause Unplanned
Readmission (HWR) Rate for the Merit-Based Incentive Payment
Systems (MIPS) Groups
(Collection Type: Administrative Claims)
(!!) Q484: Clinician and Clinician Group Risk-standardized Hospital
Admission Rates for Patients with Multiple Chronic Conditions
(Collection Type: Administrative Claims)
62639
Security Risk Analysis
High Priority Practices Safety Assurance Factors for EHR Resilience
Guide (SAFER Guide)
e-Prescribing
Query of Prescription Drug Monitoring Program (PDMP)
Provide Patients Electronic Access to Their Health Information
Support Electronic Referral Loops By Sending Health Information
AND
Support Electronic Referral Loops By Receiving and Reconciling
Health lnfom1ation
OR
Health Information Exchange (HIE) Bi-Directional Exchange
OR
Enabling Exchange Under the Trusted Exchange Framework and
Common Agreement (TEFCA)
Immunization Registry Reporting
Syndromic Surveillance Reporting (Optional)
Electronic Case Reporting
Public Health Registry Reporting (Optional)
Clinical Data Registry Reporting (Optional)
Actions to Limit or Restrict Compatibility or Interoperability of
CEI-IRT
ONC Direct Review Attestation
B.12: Quality Care for the Treatment of Ear, Nose, and Throat Disorders MVP
The B.12 tables represent the measures and activities finalized within the Quality Care for the Treatment of Ear, Nose, and
Throat Disorders MVP (88 FR 79986 through 79990) with modifications proposed for the CY 2025 performance perlod/2027
MIPS payment year and future years. We request comment on the proposed modifications included in this MVP.
Quality Measures
We are proposing to modify the previously finalized Quality Care for the Treatment of Ear, Nose, and Throat Disorders MVP
within the quality performance category of this MVP to remove two QCDR measures whose quality actions reflect a standard of
care based upon clinical guidelines recognized as best practices by health care clinicians. Based upon MIPS performance data,
AAO16 is high performing and AAO23 has had minimal variation in its historical benchmark. Though allergic rhinitis falls
within the spectrum of care otolaryngologists provide, the complexity of caring for the condition is typically low. Many nonsurgical clinician specialties, including primary care, treat allergic rhinitis regularly. Further, measure AAO23 requires the use of
medications that all are available over the counter. Removal of AAO23 will encourage u_~e of other measures within the MVP
that represent the complexity of care otolaryngologists provide.
•
AAO16: Age-Related Hearing Loss: Audiometric Evaluation
•
AAO23: Allergic Rhinitis: Intranasal Corticosteroids or Oral Antihistamines
For the reasons stated in the introduction of this appendix 1034, we are proposing the following: add the proposed modified
IA_ERP_6 to all new and previously finalized MVPs because of the importance of vaccination status in practice settings; remove
the weights associated with the improvement activities contained in this MVP; and remove two improvement activities being
proposed for removal from MIPS:
•
IA_CC_ I: Implementation of Use of Specialist Reports Back to Referring Clinician or Group to Close Referral Loop
•
1A_EPA_ 1: Provide 24/7 Access to MIPS Eligible Clinicians or Groups Who Have Real-Time Access to Patient's
Medical Record
1034 See MVP Development: Improvement Activity Policy Update and Global Inclusion of an Improvement Activity
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Improvement Activities
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We are proposing to modify the IA_BE_4: Engagement of patients through implementation of improvements in patient portal
improvement activity, which includes a proposed activity title update. Please see Appendix 2, Improvement Activities: Table
Group B of this proposed rule for all proposed revisions to this activity.
Symbol Key:
Plus sign (+ ): proposed additions of MIPS quality measures, improvement activities, or cost measures
Single asterisk(*): existing measures and improvement activities with proposed revisions
Double asterisk(**): measures and improvement activities only available when included in an MVP
Single exclamation point(!): high priority measures
Double exclamation point(!!): outcome measures
Tilde(-): measures and improvement activities that include a health equity component
Percent(%): attestation to IA_PCMH: Electronic submission of Patient Centered Medical Home accreditation provides full credit
for the improvement activity performance category
TABLE B.12a: Quality Care for the Treatment of Ear, Nose, and Throat Disorders MVP Measures and Improvement
Activities
(**) Q128: Preventive Care and Screening:
Body Mass Index (BMI) Screening and
Follow-Up Plan
(Collection Type: Medicare Part B Claims
Measure Specifications, eCQM
Specifications, MIPS CQMs Specification)
Q226: Preventive Care and Screening:
Tobacco Use: Screening and Cessation
Intervention
(Collection Type: Medicare Part B Claims
Measure Specifications, eCQM
Specifications, MIPS CQMs Specification)
(*) Q277: Sleep Apnea: Severity Assessment
at Initial Diagnosis
(Collection Type: MIPS CQMs
Specifications)
(*)(!) Q331: Adult Sinusitis: Antibiotic
Prescribed for Acute Viral Sinusitis (Overuse)
(Collection Type: MIPS CQMs
Specifications)
(!) Q332: Adult Sinusitis: Appropriate Choice
of Antibiotic: Amoxicillin With or Without
Clavulanate Prescribed for Patients with
Acute Bacterial Sinusitis (Appropriate Use)
(Collection Type: MIPS CQMs
Specifications)
(*)(!!) Q355: Unplanned Reoperation within
the 30 Day Postoperative Period
(Collection Type: MIPS CQMs
Specifications)
(!!) Q357: Surgical Site Infection (SSI)
(Collection Type: MIPS CQMs
Specifications)
(~) IA_AHE_3: Promote use of PatientReported Outcome Tools
(High)
Medicare Spending Per Beneficiary
(MSPB) Clinician
H IA_AHE_5: MIPS Eligible Clinician
Leadership in Clinical Trials or CBPR
(Medium)
(*) IA_BE_4: Engagement of patients
through implementation of improvements in
patient portal
(Medium)
IA_BE_15: Engagement of patients, family
and caregivers in developing a plan of care
(Medium)
IA_CC_13: Practice improvements to align
with OpenNotes principles
(Medium)
(+)(*) IA_ERP_6: COVID-19 Vaccine
Achievement for Practice Staff
(Medium)
(**) IA_MVP: Practice-Wide Quality
Improvement in MIPS Value Pathways
(High)
(%) IA_PCMH: Electronic submission of
Patient Centered Medical Home accreditation
IA_PM_16: Implementation of medication
management practice improvements
(Medium)
H IA_pSPA_7: Use ofQCDR data for
ongoing practice assessment and
improvements
(Medium)
EP31JY24.618
AAO20: Tympanostomy Tubes:
Comprehensive Audiometric Evaluation
(Collection Type: QCDR)
AAO21: Otitis Media with Effusion (OME):
Comprehensive Audiometric Evaluation for
Chronic OME > or= 3 months
Collection T e: CDR
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(-)(!) Q487: Screening for Social Drivers of
Health
(Collection Type: MIPS CQMs
Specifications)
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(!!) Q479: Hospital-Wide, 30-Day, All-Cause Unplanned
Readmission (HWR) Rate for the Merit-Based Incentive Payment
Systems (MIPS) Groups
(Collection Type: Administrative Claims)
(!!) Q484: Clinician and Clinician Group Risk-standardized Hospital
Admission Rates for Patients with Multiple Chronic Conditions
(Collection Type: Administrative Claims)
62641
Security Risk Analysis
High Priority Practices Safety Assurance Factors for EHR Resilience
Guide (SAFER Guide)
e-Prescribing
Query of Prescription Drug Monitoring Program (PDMP)
Provide Patients Electronic Access to Their Health Information
Support Electronic Referral Loops By Sending Health Information
AND
Support Electronic Referral Loops By Receiving and Reconciling
Health Information
OR
Health Information Exchange (HIE) Bi-Directional Exchange
OR
Enabling Exchange Under the Trusted Exchange Framework and
Common Agreement (TEFCA)
Immunization Registry Reporting
Syndromic Surveillance Reporting (Optional)
Electronic Case Reporting
Public Health Registry Reporting (Optional)
Clinical Data Registry Reporting (Optional)
Actions to Limit or Restrict Compatibility or Interoperability of
CEHRT
ONC Direct Review Attestation
B.13: Quality Care in Mental Health and Substance Use Disorders MVP
The B.13 tables represent the measures and activities finalized within the Quality Care in Mental Health and Substance Use
Disorders MVP (88 FR 79986 through 8000 l) with modifications proposed for the CY 2025 performance period/2027 MIPS
payment year and future years. We request comment on the proposed modifications included in this MVP.
Improvement Activities
For the reasons stated in the introduction of this appendix 1°35, we are proposing the following: add the proposed modified
TA_ERP_6 to all new and previously finalized MVPs because of the importance of vaccination status in practice settings; and
remove the weights associated with the improvement activities contained in this MVP.
1035 Sec MVP Development: Improvement Activity Policy Update and Global Inclusion ofan Improvement Activity
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Symbol Key:
Plus sign(+): proposed additions ofMWS quality measures, improvement activities, or cost measures
Single asterisk(*): existing measures and improvement activities with proposed revisions
Double asterisk(**): measures and improvement activities only available when included in an MVP
Single exclamation point(!): high priority mea~ures
Double exclamation point(!!): outcome measures
Tilde(-): measures and improvement activities that include a health equity component
Percent(%): attestation to IA_PCMH: Electronic submission of Patient Centered Medical Home accreditation provides full credit
for the improvement activity performance category
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(*) Q009: Antidepressant Medication
Management
(Collection Type: eCQM Specifications)
(~) IA_AHE_l: Enhance Engagement of
Medicaid and Other Underserved Populations
(High)
Q134: Preventive Care and Screening:
Screening for Depression and Follow-Up
Plan
(Collection Type: Medicare Part B Claims
Measure Specifications, eCQM
Specifications, MIPS CQMs Specification)
H IA_AHE_J: Promote use of Patient-
Medicare Spending Per Beneficiary
(MSPB) Clinician
Depression
Q366: Follow-Up Care for Children
Prescribed ADHD Medication (ADD)
(Collection Type: eCQM Specifications)
(!!) Q370: Depression Remission at Twelve
Months
(Collection Type: eCQM Specifications,
MIPS CQMs Specification)
(!) Q382: Child and Adolescent Major
Depressive Disorder (MDD): Suicide Risk
Assessment
(Collection Type: eCQM Specifications)
(*)(! !) QJSJ: Adherence to Antipsychotic
Medications For Individuals with
Schizophrenia
(Collection Type: MIPS CQMs
Specifications)
(!) Q468: Continuity of Pharmacotherapy
for Opioid Use Disorder (OUD)
(Collection Type: MIPS CQMs
Specifications)
(~)(!) Q487: Screening for Social Drivers of
Health
(Collection Type: MIPS CQMs
Specifications)
(!!) Q502: Improvement or Maintenance of
Functioning for Individuals with a Mental
and/or Substance Use Disorder
(Collection Type: MIPS CQMs
Specifications)
(!) Q504: Initiation, Review, And/Or Update
To Suicide Safety Plan For Individuals With
Suicidal Thoughts, Behavior, Or Suicide
Risk
(Collection Type: MIPS CQMs
Specifications)
(*)(!!) Q505: Reduction in Suicidal Ideation
or Behavior Symptoms
(Collection Type: MIPS CQMs
Specifications)
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(!!) MBHR2: Anxiety Response at 6-months
(Collection Type: QCDR)
(!!) MBHR7: Posttraumatic Stress Disorder
(PTSD) Outcome Assessment for Adults and
Children
Collection T ' e: QCDR)
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(~) IA_AHE_5: MIPS Eligible Clinician
Leadership in Clinical Trials or CBPR
(Medium)
H IA_AHE_9: Implement Food Insecurity
and Nutrition Risk Identification and
Treatment Protoco Is
(Medium)
(~) IA_AHE_t2: Practice Improvements that
Engage Community Resources to Address
Drivers of Health
(High)
IA_BE_12: Use evidence-based decision aids
to support shared decision-making.
(Medium)
(~) IA_BE_16: Promote Self-management in
Usual Care
(Medium)
IA_Blc_23: Integration of patient coaching
practices between visits
(Medium)
IA_BMH_2: Tobacco use
(Medium)
IA_BMH_5: MDD prevention and treatment
interventions
(Medium)
H
lA_BMH_7: Implementation of
Integrated Patient Centered Behavioral Health
Model
(High)
(~) IA_BMH_14: Behavioral/Mental Health
and Substance Use Screening and Referral for
Pregnant and Postpartum Women
H IA_BMH_15: Behavioral/Mental Health
and Substance Use Screening and Referral for
Older Adults
(High)
IA_EPA_2: Use oftelehealth services that
expand practice access
(Medium)
(+)(*) IA_ERP_6: COVID-19 Vaccine
Achievement for Practice Staff
(Medium)
(**) IA_MVP: Practice-Wide Quality
Improvement in MIPS Value Pathways
(High)
(%) IA_PCMH: Electronic submission of
Patient Centered Medical Home accreditation
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(!) Q305: Initiation and Engagement of
Substance Use Disorder Treatment
(Collection Type: eCQM Specifications)
Psychoses and Related Conditions
Reported Outcome Tools
(High)
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(~) IA_PM_6: Use oftoolsets or other
resources to close healthcare disparities
across communities
(Medium)
IA_PSPA_32: Use of CDC Guideline for
Clinical Decision Support to Prescribe
Opioids for Chronic Pain via Clinical
Decision Support
Hi h)
(!!) Q479: Hospital-Wide, 30-Day, All-Cause Unplanned
Readmission (HWR) Rate for the Merit-Based Incentive Payment
Systems (MIPS) Groups
(Collection Type: Administrative Claims)
(!!) Q484: Clinician and Clinician Group Risk-standardized Hospital
Admission Rates for Patients with Multiple Chronic Conditions
(Collection Type: Administrative Claims)
Security Risk Analysis
High Priority Practices Safety Assurance Factors for EHR Resilience
Guide (SAFER Guide)
e-Prescribing
Query of Prescription Drug Monitoring Program (POMP)
Provide Patients Electronic Access to Their Health Information
Support Electronic Referral Loops By Sending Health Information
AND
Support Electronic Referral Loops By Receiving and Reconciling
Health Information
OR
Health Information Exchange (HIE) Bi-Directional Exchange
OR
Enabling Exchange Under the Trusted Exchange Framework and
Common Agreement (TEFCA)
Irnrnuniz.ation Registry Reporting
Syndromic Surveillance Reporting (Optional)
Electronic Case Reporting
Public Health Registry Reporting (Optional)
Clinical Data Registry Reporting (Optional)
Actions to Limit or Restrict Compatibility or lnteroperability of
CEHRT
ONC Direct Review Attestation
B.14: Rehabilitative Support for Musculoskeletal Care MVP
The B.14 tables represent the measures and activities finalized within the Rehabilitative Support for Musculoskeletal Care MVP
(88 FR 80002 through 80007) with modifications proposed for the CY 2025 performance period/2027 MIPS payment year and
future years. We request comment on the proposed modifications included in this MVP.
We are proposing to modify the previously finalized Rehabilitative Support for Musculoskeletal Care MVP within the quality
performance category of this MVP to include one additional MIPS quality measure and four QCDR measures that are relevant to
patienl~ receiving rehabilitative support for Musculoskeletal Care. We reviewed the MIPS quality measure inventory and
considered feedback received during the 2024 MVP maintenance period to determine which quality measures to include in this
MVP.
•
0050: Urinary Incontinence: Plan of Care for Urinarv Incontinence in Women Aged 65 Ycars and Older: This MIPS
quality measure ensures that female patients with a diagnosis of urinary incontinence have a documented plan of care
regarding rehabilitative treatment for urinary incontinence at least once within 12 months. A rehabilitation plan of care
for these patients would address the musculoskclctal impairments of the pelvic floor related to urinary incontinence in
women.
•
MSK6: Patients Suffering From a Neck Injury who Improve Pain: This QCDR measure evaluates patients with a neck
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•
•
•
injury for achieving the minimal clinically important difference (MCTD) improvement in pain by the end of treatment.
MSK7: Patients Suffering From an Upper Extremity Injury who Improve Pain: This QCDR measure evaluates patients
with an upper extremity injury for achieving the minimal clinically important difference (MCID) improvement in pain
by the end of treatment.
MSK8: Patients Suffering From a Back Injury who Improve Pain: This QCDR measure evaluates patients with a back
injury for achieving the minimal clinically important difference (MCTD) improvement in pain by the end of treatment.
MSK9: Patients Suffering From a Lower Extremity Injury who Improve Pain: This QCDR measure evaluates patients
with a lower extremity injury for achieving the minimal clinically important difference (MCID) improvement in pain
by the end of treatment.
Improvement Activities
For the reasons stated in the introduction of this appendix1036, we are proposing the following: add the proposed modified
IA_ERP_6 to all new and previously finalized MVPs because of the importance of vaccination status in practice settings; remove
the weights associated with the improvement activities contained in this MVP; and remove two improvement activities being
proposed for removal from MIPS:
•
IA_CC_ I : Implementation of Use of Specialist Reports Back to Referring Clinician or Group to Close Referral Loop
•
IA_EPA_I: Provide 24/7 Access to MIPS Eligible Clinicians or Groups Who Have Real-Time Access to Patient's
Medical Record
(~) IA_AHE_J: Promote use of Patient(+)(!) Q050: Urinary Incontinence: Plan of
Low Back Pain
Care for Urinary Incontinence in Women Aged Reported Outcome Tools
(High)
65 Years and Older
(Collection Type: MIPS CQMs Specifications)
(~) IA_AHE_6: Provide Education
(**) Q128: Preventive Care and Screening:
Opportunities for New Clinicians
Body Mass Index (BMI) Screening and
(High)
Follow-Up Plan
(Collection Type: Medicare Part B Claims
(~) IA_AHE_9: Implement Food Insecurity
Measure Specifications, eCQM Specifications, and Nutrition Risk Identification and
MIPS CQMs Specification)
Treatment Protocols
(Medium)
(*)(!) Q155: Falls: Plan of Care
(Collection Type: Medicare Part B Claims
(~) IA_AHE_12: Practice Improvements that
Measure Specifications, MIPS CQMs
Engage Community Resources to Address
Specification)
Drivers of Health
(High)
(!!) Q217: Functional Status Change for
Patients with Knee Impairments
IA_BE_6: Regularly Assess Patient
(Collection Type: MIPS CQMs Specifications) Experience of Care and Follow Up on
Findings
(!!) Q218: Functional Status Change for
(High)
Patients with Hip Impairments
(Collection Type: MIPS CQMs Specifications) IA_BMH_12: Promoting Clinician WellBeing
(High)
(!!) Q219: Functional Status Change with
Lower Leg, Foot or Ankle Impairments
(Collection Type: MIPS CQMs Specifications) (~)IA_BMH_l5: Behavioral/Mental Health
and Substance Use Screening and Referral for
(!!) Q220: Functional Status Change for
Older Adults
(High)
Patients with Low Back Impairments
(Collection Type: MIPS CQMs Specifications)
IA CC 8: Im lementation of documentation
1036 See MVP Development: Improvement Activity Policy Update and Global Inclusion of an Improvement Activity
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Symbol Key:
Plus sign(+): proposed additions ofMIPS quality measures, improvement activities, or cost measures
Single asterisk (*): existing measures and improvement activities with proposed revisions
Double asterisk(**): measures and improvement activities only available when included in an MVP
Single exclamation point(!): high priority measures
Double exclamation point(!!): outcome measures
Tilde(-): measures and improvement activities that include a health equity component
Percent(%): attestation to IA_PCMH: Electronic submission of Patient Centered Medical Home accreditation provides full credit
for the improvement activity performance category
Pound sign (#): QCDR measures pending testing data
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
62645
(!!) Q221: Functional Status Change for
improvements for practice/process
Patients with Shoulder Impairments
improvements
(Collection Type: MIPS CQMs Specifications) (Medium)
(!!) Q222: Functional Status Change for
Patients with Elbow, Wrist or Hand
Impairments
(Collection Type: MIPS CQMs Specifications)
IA_CC_12: Care coordination agreements
that promote improvements in patient
tracking across settings
(Medium)
(!!) Q478: Functional Status Change for
IA_EPA_2: Use oftelehealth services that
Patients with Neck Impairments
expand practice access
(Collection Type: MIPS CQMs Specifications) (Medium)
(-)(!) Q487: Screening for Social Drivers of
(-) IA_EPA_3: Collection and use of patient
Health
experience and satisfaction data on access
(Collection Type: MIPS CQMs Specifications) (Medium)
(+)(!!)(#) MSK6: Patients Suffering From a
Neck Injury who Improve Pain
(Collection Type: QCDR)
(+)(*) IA_ERP_6: COVTD-19 Vaccine
Achievement for Practice Staff
(Medium)
(+)(!!)(#) MSK7: Patients Suffering From an
Upper Extremity Injury who Improve Pain
(Collection Type: QCDR)
(**) IA_MVP: Practice-Wide Quality
Improvement in MIPS Value Pathways
(High)
(+)(!!)(#) MSK8: Patients Suffering From a
Back Injury who Improve Pain
(Collection Type: QCDR)
(%) IA_PCMH: Electronic submission of
Patient Centered Medical Home accreditation
(+)(!!)(#) MSK9: Patients Suffering From a
Lower Extremity Injury who Improve Pain
(Collection Type: QCDR)
IA_PSPA_16: Use decision support-ideally
platform-agnostic, interoperable clinical
decision support (CDS) tools -and
standardized treatment protocols to manage
workflow on the care team to meet patient
needs
(Medium)
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IA_PSPA_21: Implementation offal!
screening and assessment programs
(Medium)
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(!!) Q479: Hospital-Wide, 30-Day, All-Cause Unplanned Readmission
(HWR) Rate for the Merit-Based Incentive Payment Systems (MIPS)
Groups
(Collection Type: Administrative Claims)
(!!) Q484: Clinician and Clinician Group Risk-standardized Hospital
Admission Rates for Patients with Multiple Chronic Conditions
(Collection Type: Administrative Claims)
Security Risk Analysis
High Priority Practices Safety Assurance Factors for EHR
Resilience Guide (SAFER Guide)
e-Prescribing
Query of Prescription Drug Monitoring Program (PDMP)
Provide Patients Electronic Access to Their Health Information
Support Electronic Referral Loops By Sending Health Information
AND
Support Electronic Referral Loops By Receiving and Reconciling
Health Information
OR
Health Information Exchange (HIE) Bi-Directional Exchange
OR
Enabling Exchange Under the Trusted Exchange Framework and
Common Agreement (TEFCA)
Immunization Registry Reporting
Syndromic Surveillance Reporting (Optional)
Electronic Case Reporting
Public Health Registry Reporting (Optional)
Clinical Data Registry Reporting (Optional)
Actions to Limit or Restrict Compatibility or Interoperability of
CEHRT
ONC Direct Review Attestation
B.15: Value in Primary Care MVP
The B.15 tables represent the measures and activities finalized within the Value in Primary Care MVP (88 FR 80042 through
80047) with modifications proposed for the CY 2025 performance period/2027 MWS payment year and future years. We request
comment on the proposed modifications included in this MVP.
Quality Measures
We are not proposing to modify the previously finalized Value in Primary Care MVP within the quality performance category of
this MVP by proposing to add or remove quality measures from the MVP. However, we are proposing to modify the Q00l:
Diabetes: Hemoglobin Ale (HbAlc) Poor Control (>9%) quality measure, which includes a proposed measure title update.
Please see Appendix 1: MIPS Quality Measures, Table Group D of this proposed rule for all proposed revisions to this measure.
Improvement Activities
In addition, we are proposing the following: remove the weights associated with the improvement activities contained in this
MVP; and remove two improvement activities being proposed for removal from MIPS:
•
IA_CC_2: Implementation of improvements that contribute to more timely communication of test results
1037 See MVP Development: Improvement Activity Policy Update and Global Inclusion of an Improvement Activity
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For the reasons stated in the introduction of this appendix1037, we are proposing the following: add the proposed modified
IA_ERP_6 to all new and previously finalized MVPs because of the importance of vaccination status in practice settings; and add
a proposed improvement activity that addresses risk for heart disease, the leading cause of death in the United States, as well as
risk for stroke, which is the fifth most common cause of death. Promoting the implementation of standardized, evidence-based
cardiovascular disease risk assessment and care management in the primary care setting has the potential to impact patient
outcomes sizably and positively. This new activity, IA_PM_XX, is based on the results of the CMS Innovation Center Million
Hearts Model:
•
IA_PM_XX: Save a Million Hearts: Standardization of Approach to Screening and Treatment for Cardiovascular
Disease Risk
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Proposed Rules
•
62647
IA_EPA_ 1: Provide 24/7 Access to MIPS Eligible Clinicians or Groups Who Have Real-Time Access to Patient's
Medical Record
We are proposing to modify the IA_BE_4: Engagement of patients through implementation of improvements in patient portal
improvement activity, which includes a proposed activity title update. Please see Appendix 2, Improvement Activities: Table
Group B of this proposed rule for all proposed revisions to this activity.
Symbol Key:
Plus sign(+): proposed additions of MIPS quality measures, improvement activities, or cost measures
Carat symbol("): new proposed measures and improvement activities
Single asterisk(*): existing measures and improvement activities with proposed revisions
Double asterisk(**): measures and improvement activities only available when included in an MVP
Single exclamation point(!): high priority measures
Double exclamation point(!!): outcome measures
Tilde(-): measures and improvement activities that include a health equity component
Percent(%): attestation to IA_PCMH: Electronic submission of Patient Centered Medical Home accreditation provides full credit
for the improvement activity performance category
(*)(!) Q047: Advance Care Plan
(Collection Type: Medicare Part B Claims
Measure Specifications, MIPS CQMs
Specifications)
Q 134: Preventive Care and Screening:
Screening for Depression and Follow-Up
Plan
(Collection Type: Medicare Part B Claims
Measure Specifications, eCQM
Specifications, MIPS CQMs Specifications)
(*)(!!) Q236: Controlling High Blood
Pressure
(Collection Type: Medicare Part B Claims
Measure Specifications, eCQM
Specifications, MIPS CQMs Specifications)
(!) Q305: Initiation and Engagement of
Substance Use Disorder Treatment
(Collection Type: eCQM Specifications)
(!) Q321: CARPS for MIPS Clinician/Group
Survey
(Collection Type: CARPS Survey Vendor)
Q438: Stalin Therapy for the Prevention and
Treatment of Cardiovascular Disease
(Collection Type: eCQM Specifications,
MIPS CQMs Specifications)
Q475: HIV Screening
(Collection Type: eCQM Specifications)
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(!!) Q483: Person-Centered Primary Care
Measure Patient Reported Outcome
Performance Measure (PCPCM PRO-PM)
(Collection Type: MIPS CQMs
Specifications)
(~)(!) Q487: Screening for Social Drivers of
Health
(Collection Type: MIPS CQMs
S cifications
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(~) IA_AHE_3: Promote use of PatientReported Outcome Tools
(High)
Asthma/Chronic Obstructive
Pulmonary Disease (COPD)
Diabetes
(~) JA_AHE_9: Implement Food Insecurity
and Nutrition Risk Identification and
Treatment Protocols
(Medium)
(~) IA_AHE_12: Practice Improvements that
Engage Community Resources to Address
Drivers of Health
(High)
Depression
Heart Failure
Total Per Capita Cost (TPCq
(*) IA_BE_4: Engagement of patients through
implementation of improvements in patient
portal
(Medium)
IA_BE_6: Regularly Assess Patient
Experience of Care and Follow Up on Findings
(High)
IA_BE_12: Use evidence-based decision aids
to support shared decision-making
(Medium)
IA_CC_13: Practice improvements to align
with OpenNotes principles
(Medium)
(+)(*) IA_ERP_6: COVID-19 Vaccine
Achievement for Practice Staff
(Medium)
(**) IA_MVP: Practice-Wide Quality
Improvement in MIPS Value Pathways
(High)
(%) IA_PCMH: Electronic submission of
Patient Centered Medical Home accreditation
(~) IA_PM_ 11: Regular review practices in
place on targeted patient population needs
(Medium)
L.\_PM_l3: Chronic care and preventative
care management for empaneled patient
(Medium)
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(*)(!!) QOOl: Diabetes: Hemoglobin Ale
(HbAlc) Poor Control (>9%)
(Collection Type: Medicare Part B Claims
Measure Specifications, eCQM
Specifications, MIPS CQMs Specifications)
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IA_PM_16: Implementation of medication
management practice improvements
(Medium)
(*) Q493: Adult Immunization Status
(Collection Type: MIPS CQMs
Specifications)
(*) Q497: Preventive Care and Wellness
(composite)
(Collection Type: MIPS CQMs
Specifications)
(!) Q504: Initiation, Review, And/Or Update
To Suicide Safety Plan For Individuals With
Suicidal Thoughts, Behavior, Or Suicide
Risk
(Collection Type: MIPS CQMs
Specifications)
(-) IA_PM_22: Improving Practice Capacity
for Human Immunodeficiency Virus (HIV)
Prevention Services
(Medium)
(-) IA_PM_23: Use of Computable Guidelines
and Clinical Decision Support to Improve
Adherence for Cervical Cancer Screening and
Management Guidelines
(High)
C')(+) IA_pM_XX: Save a Million Hearts:
Standardization of Approach to Screening and
Treatment for Cardiovascular Disease Risk
(Hi h)
(!!) Q479: Hospital-Wide, 30-Day, All-Cause Unplanned
Readmission (HWR) Rate for the Merit-Based Incentive Payment
Systems (MIPS) Groups
(Collection Type: Administrative Claims)
(!!) Q484: Clinician and Clinician Group Risk-standardized Hospital
Admission Rates for Patients with Multiple Chronic Conditions
(Collection Type: Administrative Claims)
Security Risk Analysis
High Priority Practices Safety Assurance Factors for EHR Resilience
Guide (SAFER Guide)
e-Prescribing
Query of Prescription Drug Monitoring Program (PDMP)
Provide Patients Electronic Access to Their Health Information
Support Electronic Referral Loops By Sending Health Information
AND
Support Electronic Referral Loops By Receiving and Reconciling
Health Information
OR
Health Information Exchange (HIE) Bi-Directional Exchange
OR
Enabling Exchange Under the Trusted Exchange Framework and
Common Agreement (TEFCA)
Immunization Registry Reporting
Syndromic Surveillance Reporting (Optional)
Electronic Case Reporting
Public Health Registry Reporting (Optional)
Clinical Data Registry Reporting (Optional)
Actions to Limit or Restrict Compatibility or Interoperability of
CEHRT
ONC Direct Review Attestation
EP31JY24.627
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[FR Doc. 2024–14828 Filed 7–10–24; 4:15 pm]
Agencies
[Federal Register Volume 89, Number 147 (Wednesday, July 31, 2024)]
[Proposed Rules]
[Pages 61596-62648]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-14828]
[[Page 61595]]
Vol. 89
Wednesday,
No. 147
July 31, 2024
Part II
Book 2 of 2 Books
Pages 61595-62652
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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42 CFR Parts 401, 405, et al.
Medicare and Medicaid Programs; CY 2025 Payment Policies Under the
Physician Fee Schedule and Other Changes to Part B Payment and Coverage
Policies; Medicare Shared Savings Program Requirements; Medicare
Prescription Drug Inflation Rebate Program; and Medicare Overpayments;
Proposed Rule
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 /
Proposed Rules
[[Page 61596]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 401, 405, 410, 411, 414, 423, 424, 425, 427, 428, and
491
[CMS-1807-P]
RIN 0938-AV33
Medicare and Medicaid Programs; CY 2025 Payment Policies Under
the Physician Fee Schedule and Other Changes to Part B Payment and
Coverage Policies; Medicare Shared Savings Program Requirements;
Medicare Prescription Drug Inflation Rebate Program; and Medicare
Overpayments
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; codification of, and proposing policies for, the Medicare
Prescription Drug Inflation Rebate Program under the Inflation
Reduction Act of 2022; updates to the Medicare Diabetes Prevention
Program expanded model; payment for dental services inextricably linked
to specific covered medical services; updates to drugs and biological
products paid under Part B including immunosuppressive drugs and
clotting factors; 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
policies for Rural Health Clinics and Federally Qualified Health
Centers; electronic prescribing for controlled substances for a covered
Part D drug under a prescription drug plan or a Medicare Advantage
Prescription Drug (MA-PD) plan under the Substance Use-Disorder
Prevention that Promotes Opioid Recovery and Treatment for Patients and
Communities Act (SUPPORT Act); update to the Ambulance Fee Schedule
regulations; codification of the Inflation Reduction Act and
Consolidated Appropriations Act, 2023 provisions; updates to Clinical
Laboratory Fee Schedule regulations; updates to the diabetes payment
structure and PHE flexibilities; expansion of colorectal cancer
screening and Hepatitis B vaccine coverage and payment; establishing
payment for drugs covered as additional preventive services; Medicare
Parts A and B Overpayment Provisions of the Affordable Care Act.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. on September 9,
2024.
ADDRESSES: In commenting, please refer to file code CMS-1807-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-1807-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-1807-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, Morgan Kitzmiller, (410) 786-1623,
or [email protected], for issues related to
practice expense, work RVUs, conversion factor, and PFS specialty-
specific impacts.
Kris Corwin, (410) 786-8864, or
[email protected], for issues related to
strategies for updates to practice expense data collection and
methodology.
Hannah Ahn, (814) 769-0143, or
[email protected], for issues related to
potentially misvalued services under the PFS.
Kris Corwin, (410) 786-8864, Patrick Sartini, (410) 786-9252,
Mikayla Murphy, (667) 414-0093, or
[email protected], 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, or
[email protected], for issues related to
teaching physician billing for services involving residents in teaching
settings.
Sarah Leipnik, (410) 786-3933, Mikayla Murphy, (667) 414-0093,
Regina Walker-Wren, (410) 786-9160, or
[email protected], for issues related to payment
for caregiver training services and addressing health-related social
needs (community health integration, principal illness navigation, and
social determinants of health risk assessment).
Erick Carrera, (410) 786-8949, or
[email protected], for issues related to office/
outpatient evaluation and management visit inherent complexity add-one.
Sarah Irie, (410) 786-1348, Emily Parris (667) 414-0418, or
[email protected], for issues related to payment
for advanced primary care management service.
Sarah Leipnik, (410) 786-3933, or
[email protected], for issues related to global
surgery payment accuracy.
Pamela West, (410) 786-2302, for issues related to supervision of
outpatient therapy services in private practices, certification of
therapy plans of care, and KX modifier threshold.
Lindsey Baldwin, (410) 786-1694, Regina Walker-Wren, (410) 786-
9160, Erick Carrera, (410) 786-8949, Mikayla Murphy, (667) 414-0093, or
[email protected], for issues related to
advancing access to behavioral health 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.
Zehra Hussain, (214) 767-4463, or
[email protected], for issues related to payment
of skin substitutes.
Laura Kennedy, (410) 786-3377, Adam Brooks, (202) 205-0671, Rachel
Radzyner, (410) 786-8215, Rebecca Ray, (667) 414-0879, and Jae Ryu,
(667) 414-0765 for issues related to Drugs and Biological Products Paid
Under Medicare Part B.
[email protected], for issues related to
complex drug administration.
[[Page 61597]]
Glenn McGuirk, (410) 786-5723, 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.
Heidi Oumarou, (410) 786-7942, for issues related to the FQHC
market basket.
Michele Franklin, (410) 786-9226, or [email protected], for issues
related to RHC payments.
Kianna Banks (410) 786-3498 and Cara Meyer (667) 290-9856, for
issues related to RHCs and FQHCs and Conditions for Certification or
Coverage.
Colleen Barbero (667) 290-8794, for issues related to Medicare
Diabetes Prevention Program.
Ariana Pitcher, (667) 290-8840, or [email protected], for
issues related to Medicare coverage of opioid use 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 [email protected],
for issues related to Shared Savings Program beneficiary assignment and
benchmarking methodology.
Richard (Chase) Kendall, (410) 786-1000, or
[email protected], for issues related to reopening ACO
payment determinations, and mitigating the impact of significant,
anomalous, and highly suspect billing activity on Shared Savings
Program financial calculations.
Lucy Bertocci, (410) 786-3776, or [email protected],
for issues related to Shared Savings Program prepaid shared savings,
advance investment payments, beneficiary notice and eligibility
requirements.
Rachel Radzyner, (410) 786-8215, for issues related to payment for
preventative services, including preventive vaccine administration and
drugs covered as additional preventive services.
Elisabeth Daniel, (667) 290-8793, for issues related to the
Medicare Prescription Drug Inflation Rebate Program.
Genevieve Kehoe, [email protected], or 1-844-711-
2664 (Option 4) for issues related to the Request for Information:
Building upon the MIPS Value Pathways (MVPs) Framework to Improve
Ambulatory Specialty Care.
Kimberly Long, (410) 786-5702, for issues related to expanding
colorectal cancer screening.
Rachel Katonak, (410) 786-8564, for issues related to expanding
Hepatitis B vaccine coverage.
Mei Zhang, (410) 786-7837, 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).
Katie Parker, (410) 786-0537, for issues related to Parts A and B
overpayment provisions of the Affordable Care Act.
Amy Gruber, (410) 786-1542, for issues related to low titer O+
whole blood transfusion therapy during ground ambulance transport.
Renee O'Neill, (410) 786-8821, or Sophia Sugumar, (410) 786-1648,
for inquiries related to Merit-based Incentive Payment System (MIPS)
track of the Quality Payment Program.
Danielle Drayer, (516) 965-6630, for inquiries related to
Alternative Payment Models (APMs).
SUPPLEMENTARY INFORMATION:
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
2025 PFS proposed rule, refer to item CMS-1807-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
A. Purpose
This major annual rule proposes to revise payment policies under
the Medicare PFS and makes other policy changes, including proposals to
implement certain provisions of the Further Continuing Appropriations
and Other Extensions Act of 2024 (Pub. L. 118-22, November 16, 2023),
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.
This rulemaking also proposes to codify policies previously
established in guidance for the Medicare Prescription Drug Inflation
Rebate Program at new parts 427 and 428, including clarifications to
certain existing policies, consistent with sections 1847A(i) and 1860D-
14B of the Act. This rulemaking also proposes new policies for the
Medicare Prescription Drug Inflation Rebate Program, including removal
of units of drugs subject to discarded drug refunds from the Part B
rebate amounts, exclusion of units for which a manufacturer provides a
discount under the 340B Program from the Part D inflation rebate amount
starting on January 1, 2026, the process for reconciliation of a Part B
or Part D rebate amount to incorporate certain revised information, and
procedures for imposing civil money penalties on manufacturers that do
not pay Part B or Part D inflation rebate amounts within a specified
period of time.
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, by
clarifying the requirements and intent of the program regarding the
provision of services. We also aim to ensure RHCs are provided
flexibility in the services they offer, including specialty and
laboratory services.
[[Page 61598]]
This rulemaking also proposes to further advance Medicare's overall
value-based care strategy of growth, alignment, and equity through the
Medicare Shared Savings Program (Shared Savings Program) and the
Quality Payment Program. 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 also proposes changes to Medicare regulations
regarding requirements for reporting and returning Parts A and B
overpayments.
B. Summary of the Major Provisions
Please note, some sections of this proposed rule contain a request
for information (RFI). In accordance with the implementing regulations
of the Paperwork Reduction Act of 1995 (PRA), specifically 5 CFR
1320.3(h)(4), these general solicitations are 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. Respondents are encouraged to provide complete but concise
responses. These RFIs are issued solely for information and planning
purposes; they do not constitute a Request for Proposal (RFP),
applications, proposal abstracts, or quotations. These RFIs do not
commit the U.S. Government to contract for any supplies or services or
make a grant award. Further, CMS is not seeking proposals through these
RFIs 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 these RFIs; all costs
associated with responding to these RFIs will be solely at the
interested party's expense. Not responding to these RFIs does not
preclude participation in any future procurement, if conducted. It is
the responsibility of the potential responders to monitor these RFI
announcements for additional information pertaining to these requests.
Please note that CMS will not respond to questions about the policy
issues raised in these RFIs. CMS may or may not choose to contact
individual responders. Such communications would only serve to further
clarify written responses. Contractor support personnel may be used to
review RFI responses. 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 these RFIs may be
used by the U.S. Government for program planning on a non-attribution
basis. Respondents should not include any information that might be
considered proprietary or confidential. These RFIs 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. CMS may publicly post the
comments received, or a summary thereof.
Section 1848 of the Social Security Act (the Act) 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.
In this major proposed rule, we are proposing to establish RVUs for
CY 2025 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 Act (section II.D.)
Valuation of Specific Codes (section II.E.)
Evaluation and Management (E/M) Visits (section II.F.)
Enhanced Care Management (section II.G.)
Supervision of Outpatient Therapy Services in Private
Practices, Certification of Therapy Plans of Care with a Physician or
NPP Order, and KX Modifier Thresholds (section II.H.)
Advancing Access to Behavioral Health Services (section II.I.)
Proposals on Medicare Parts A and B Payment for Dental
Services Inextricably Linked to Specific Covered Services (section
II.J.)
Payment for Skin Substitutes (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 Clinic (RHC) and Federally Qualified Health
Center (FQHC) Conditions for Certification and Conditions for Coverage
(CfCs) (section III.C.)
Clinical Laboratory Fee Schedule: Revised Data Reporting
Period and Phase-in of Payment Reductions (section III.D.)
Medicare Diabetes Prevention Program (MDPP) (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 Services (Sec. Sec.
410.10, 410.57, 410.64, 410.152) (section III.H.)
Medicare Prescription Drug Inflation Rebate Program (section
III.I.)
Request for Information: Building upon the MIPS Value Pathways
(MVPs) Framework to Improve Ambulatory Specialty Care (section III.J.)
Expand Colorectal Cancer Screening (section III.K.)
Requirements for Electronic Prescribing for Controlled
Substances for a Covered Part D Drug under a Prescription Drug Plan or
an MA-PD Plan (section III.L.)
Expand Hepatitis B Vaccine Coverage (section III.M.)
Low Titer O+ Whole Blood Transfusion Therapy During Ground
Ambulance Transport (section III.N.)
Medicare Parts A and B Overpayment Provisions of the
Affordable Care Act (section III.O.)
Updates to the Quality Payment Program (section IV.)
[[Page 61599]]
Collection of Information Requirements (section V.)
Response to Comments (section VI.)
Regulatory Impact Analysis (section VII.)
C. Summary of Costs and Benefits
We have determined that this proposed rule is economically
significant. We estimate the CY 2025 PFS conversion factor to be
32.3562 which reflects a 0.05 percent positive budget neutrality
adjustment required 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 removal of the temporary 2.93 percent
payment increase for services furnished from March 9, 2024, through
December 31, 2024, as provided in the CAA, 2024. 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 Social Security Act (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 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 American Medical Association (AMA) 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 to
develop the indirect portion of the PE RVUs. Prior to CY 2010, we
primarily used the PE/HR by specialty 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 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 or how the PE/HR data are used. 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 are not
[[Page 61600]]
separately recognized by Medicare, nor do we have a method to blend the
PPIS data with Medicare-recognized specialty data.
Previously, we established PE/HR values for various specialties
without SMS or supplemental survey data by crosswalking them to other
similar specialties to estimate a proxy PE/HR. For specialties that
were part of the PPIS for which we previously used a crosswalked PE/HR,
we instead used the PPIS based PE/HR. We use crosswalks for specialties
that did not participate in the PPIS. These crosswalks have been
generally established through notice and comment rulemaking and are
available in the file titled ``CY 2025 PFS proposed rule PE/HR'' on the
CMS website under downloads for the CY 2025 PFS proposed rule at
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
For CY 2025, we have incorporated the available utilization data
for two new specialties, Marriage and Family Therapist (MFT) and Mental
Health Counselor (MHC), which we recognized effective January 1, 2024,
in accordance with section 4121 of the CAA, 2023. We are proposing to
use proxy PE/HR values for these new specialties, as there are no PPIS
data for these specialties, by crosswalking the PE/HR as follows from
specialties that furnish similar services in the Medicare claims data:
Marriage and Family Therapist (MFT) from Licensed Clinical
Social Workers; and
Mental Health Counselor (MHC) from Licensed Clinical Social
Workers
These updates are reflected in the ``CY 2025 PFS proposed rule PE/
HR'' file available on the CMS website under the supporting data files
for the CY 2025 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 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 healthcare 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 2025 PFS
proposed rule at https://www.cms.gov/
[[Page 61601]]
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 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 three most recent years of
available Medicare claims data to determine the specialty mix assigned
to each code. Codes with low Medicare service volume require special
attention since billing or enrollment irregularities for a given year
can result in significant changes in specialty mix assignment. We
finalized a policy in the CY 2018 PFS final rule (82 FR 52982 through
59283) to use the most recent year of claims data to determine which
codes are low volume for the coming year (those that have fewer than
100 allowed services in the Medicare claims data). For codes that fall
into this category, instead of assigning a specialty mix based on the
specialties of the practitioners reporting the services in the claims
data, we use the expected specialty that we identify on a list
developed based on medical review and input from expert interested
parties. We display this list of expected specialty assignments as part
of the annual set of data files we make available as part of notice and
comment rulemaking and consider recommendations from the RUC and other
interested parties on changes to this list annually. 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.
[[Page 61602]]
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: To
calculate the PE and MP RVUs, we exclude certain specialties, such as
NPPs paid at a percentage of the PFS and low volume specialties, from
the calculation. These specialties are included to calculate the BN
adjustment. They are displayed in Table 1.
BILLING CODE P
[[Page 61603]]
[GRAPHIC] [TIFF OMITTED] TP31JY24.000
BILLING CODE C
Crosswalk certain low volume physician specialties:
Crosswalk the utilization of certain specialties with relatively low
PFS utilization to the associated specialties.
Physical therapy utilization: Crosswalk the utilization
associated with all physical therapy services to the specialty of
physical therapy.
Identify professional and technical services not
identified under the usual TC and 26 modifiers: Flag the services that
are PC and TC services but do not use TC and 26 modifiers (for example,
electrocardiograms). This flag associates the PC and TC with the
associated global code for use in creating the indirect PE RVUs. For
example, the professional service, CPT code 93010 (Electrocardiogram,
routine ECG with at least 12 leads; interpretation and report only), is
associated with the global service, CPT code 93000 (Electrocardiogram,
routine ECG with at least 12 leads; with interpretation and report).
Payment modifiers: Payment modifiers are accounted for in
creating the file consistent with the current payment policy as
implemented in claims processing. For example, services billed with the
assistant at surgery modifier are paid 16 percent of the PFS amount for
that service; therefore, the utilization file is modified to only
account for 16 percent of any service that contains the assistant at
surgery modifier. Similarly, for those services to which volume
adjustments are made to account for the payment modifiers, time
adjustments are applied as well. For time adjustments to surgical
services, the intraoperative portion in the work time file is used;
where it is not present, the intraoperative percentage from the payment
files used by contractors to process Medicare claims is used instead.
Where neither is available, we use the payment adjustment ratio to
adjust the time accordingly. Table 2 details the
[[Page 61604]]
manner in which the modifiers are applied.
[GRAPHIC] [TIFF OMITTED] TP31JY24.001
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.
We note that for CY 2025, we are proposing mandatory use of the 54
and 55 modifiers when practitioners furnishing global surgery
procedures share in patient care and intend only to furnish
preoperative/intraoperative or postoperative portions of the total
global procedure. If finalized, this proposal will likely increase the
number of claims subject to the adjustment described in the discussion
above. We discuss this proposal in section II.G. of this proposed rule.
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)[supcaret] life of equipment)))) + maintenance)
Where:
minutes per year = maximum minutes per year if usage were continuous
(that is, usage=1); generally, 150,000 minutes.
usage = variable, see discussion 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
[[Page 61605]]
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 types of equipment, the vast
majority of which fall in the range of 5 to 10 years, and none of which
are lower than two 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 data sources containing equipment maintenance rates,
commenters could not identify an auditable, robust data source that CMS
could use 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] TP31JY24.002
We are not proposing any changes to the equipment interest rates
for CY 2025.
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 ensure 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 cost
share weights in 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 in 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 MEI to reflect more current market
conditions faced by physicians in furnishing physicians' services
(referred to as the ``2017-based MEI''). We also finalized a delay of
the adjustments to the PE pools in steps 3
[[Page 61606]]
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 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 the AMA's intent to collect practice cost data
from physician practices, which could be used to derive cost share
weights for the MEI and RVU shares.
In light of the AMA's current data collection efforts 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,
similar to our discussion of this topic in the CY 2024 PFS rulemaking
cycle (88 FR 78829 through 78831), we continue to believe that delaying
the implementation of the finalized 2017-based MEI cost share weights
for the RVUs is consistent with our efforts to balance payment
stability and predictability with incorporating new data through more
routine updates. For these reasons, we did not propose to incorporate
the 2017-based MEI in PFS ratesetting for CY 2024. As we noted in the
CY 2024 PFS final rule, many commenters on the CY 2024 PFS proposed
rule supported our continued delayed implementation of the 2017-based
MEI in PFS ratesetting (88 FR 78830). Most of these commenters urged us
to pause consideration of other sources for the MEI until the AMA's
efforts to collect practice cost data from physician practices have
concluded, although a few commenters recommended that we implement the
MEI for PFS ratesetting as soon as possible. We agree with the
commenters that it would be prudent, and avoid potential duplication of
effort, to wait to consider other data sources for the MEI while the
AMA's data collection activities are ongoing. As we discussed in the CY
2024 PFS final rule, we continue to monitor the data available related
to physician services' input expenses, but we are not proposing to
update the data underlying the MEI cost weights at this time. Given our
previously described policy goal to balance PFS payment stability and
predictability with incorporating new data through more routine updates
to the MEI, we are not proposing to incorporate the 2017-based MEI in
PFS ratesetting for CY 2025. We invite comments on this approach as
well as any information on the timing of the AMA's practice cost data
collection efforts and other sources of data we could consider for
updating the MEI.
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 2025 direct PE input public use files, which are
available on the CMS website under downloads for the CY 2025 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 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 the relativity of values among codes. For
example, as medical practice and technologies change over time,
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
[[Page 61607]]
case, 4 minutes as the standard for the complex case, and 5 minutes as
the standard for the highly complex case. These values were based upon
a review of the existing minutes assigned for this clinical labor
activity; we determined that 2 minutes is the duration for most
services and a small number of codes with more complex forms of digital
imaging have higher values. We also finalized standard times for a
series of clinical labor tasks associated with pathology services in
the CY 2016 PFS final rule with comment period (80 FR 70902). We do not
believe these activities would be dependent on number of blocks or
batch size, and we believe that the finalized standard values
accurately reflect the typical time it takes to perform these clinical
labor tasks.
In reviewing the RUC-recommended direct PE inputs for CY 2019, we
noticed that the 3 minutes of clinical labor time traditionally
assigned to the ``Prepare room, equipment and supplies'' (CA013)
clinical labor activity were split into 2 minutes for the ``Prepare
room, equipment and supplies'' activity and 1 minute for the ``Confirm
order, protocol exam'' (CA014) activity. We proposed to maintain the 3
minutes of clinical labor time for the ``Prepare room, equipment and
supplies'' activity and remove the clinical labor time for the
``Confirm order, protocol exam'' activity wherever we observed this
pattern in the RUC-recommended direct PE inputs. Commenters explained
in response that when the new version of the PE worksheet introduced
the activity codes for clinical labor, there was a need to translate
old clinical labor tasks into the new activity codes, and that a prior
clinical labor task was split into two of the new clinical labor
activity codes: CA007 (Review patient clinical extant information and
questionnaire) in the preservice period, and CA014 (Confirm order,
protocol exam) in the service period. Commenters stated that the same
clinical labor from the old PE worksheet was now divided into the 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 believe that the three 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. We direct readers to the
discussion in the CY 2019 PFS final rule (83 FR 59463 through 59464)
for additional details.
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 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 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 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. We direct readers to the discussion in the CY 2020 PFS
final rule (84 FR 62584) for additional details.
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 the RUC's development and our review of code values
for individual codes. Beginning with its recommendations for CY 2019,
the RUC mandated the use of a new PE worksheet for its 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
helps us simplify and standardize the hundreds of clinical labor tasks
currently listed in our direct PE database. As in previous calendar
years, to facilitate rulemaking for CY 2025, we are continuing to
display two versions of the Labor Task Detail public use file: one
version with the old listing of clinical labor tasks and one with the
same tasks crosswalked to the new listing of clinical labor activity
codes. These lists are available on the CMS website under downloads for
the CY 2025 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 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 2025, we are proposing to update the price of 17 supplies
and one equipment item in response to the public submission of invoices
following the publication of the CY 2024 PFS final rule. The 18 supply
and equipment items with proposed updated prices are listed in the
valuation of specific codes section of the preamble under Table 16, CY
2025 Invoices Received for Existing Direct PE Inputs.
An interested party submitted 30 invoices to update pricing for the
human amniotic membrane allograft
[[Page 61608]]
mounted on a non-absorbable self-retaining ring (SD248) supply. We
previously updated the price of this supply in the CY 2024 final rule
(88 FR 78901) based on averaging together the price of the Prokera
Slim, Prokera Classic, and Prokera Plus devices. The interested party
submitted new invoices for all three of these devices which averaged to
a new price of $1149.00 which we are proposing for the SD248 supply. We
are soliciting additional comments from interested parties regarding
the price of the SD248 supply as well as any information as far as
whether one of these three devices (the Prokera Slim, Prokera Classic,
and Prokera Plus) would be more typical than the other two for use as a
supply in CPT code 65778.
In the case of the indocyanine green (25ml uou) (SL083) supply, we
noticed that there was a clear bimodal distribution of prices on the
eight submitted invoices, clustered around $91.00 and $141.67,
respectively, with no pricing in between $100 and $140. We are
proposing the updated total average price of $125.11 based on the eight
submitted invoices for the SL083 supply, however, we are soliciting
comments on why there was such divergence in the pricing on the
submitted invoices, as well as whether these may represent pricing for
two different supplies.
Regarding the Reaction buffer 10X (Ventana 950-300) (SL478) supply,
we are proposing to update the price from $0.037 to $0.045, which is
less than the $0.075 contained on the invoice submitted by interested
parties. We were able to find this product readily available for
purchase online at a quantity of 10 liters for $453 or a price of
$0.045. We do not believe that it would be typical for providers to pay
a higher price based on smaller unit quantities; therefore, we are
proposing to update the price of the SL478 supply but only to $0.045,
which is the price to purchase this supply online, as stated above.
Interested parties also alerted CMS to a technical correction for
pricing the Atomizer tips (disposable) (SL464) supply. We previously
finalized a price of $2.66 for the SL464 supply, which was included in
the table of Invoices Received for Existing Direct PE Inputs in the CY
2018 final rule (82 FR 53162). However, due to a technical error, the
updated pricing for the SL464 supply was never implemented. We are
proposing to make this correction for CY 2025; the corrected price of
$2.66 for the SL464 supply is included in Table 16.
We are not proposing to update the price of another ten supplies,
which were the subject of public submission of invoices. Our reasons
for not proposing updates to these prices are detailed below, and we
are seeking additional information from interested parties for
assistance in pricing these supplies:
Liposorber supplies: Tubing set (SC083), Plasma LDL
adsorption column (SD186), and Plasma separator (SD188): We received
invoices for these three Liposorber supplies from an interested party.
However, it was unclear from the invoice submissions what the unit
quantity size is for each product. We require additional information
regarding the unit size of each supply included on these invoices to
establish updated pricing, and therefore, we are not proposing updates
to the prices for these supplies. We are seeking additional comments
regarding the pricing of these supplies and whether the pricing has
increased so dramatically, as it seems unlikely that prices have
tripled in the five years since we most recently updated the pricing
for these supplies.
Congo Red kits (SA110): We received three invoices from
interested parties requesting an increase in the price of the SA110
supply from $6.80 to $18.78. However, we were able to find Congo Red
staining kits readily available online at a price of 100 for $410 or
$4.10 per kit. The unit size of these kits was also unclear, which made
price comparisons with the submitted invoices difficult. Based on the
three invoices and the online price of 100 for $410 or $4.10 per kit,
we do not believe there is enough pricing data to support an increase
in the price of the SA110 supply from $6.80 to $18.78, and we are not
proposing an increase in the price of this supply.
Gauze, non-sterile 4in x 4in (SG051): We received one
invoice from interested parties requesting an increase in the price of
the SG051 supply from $0.03 to $0.04. However, the submitted invoice
price appeared to be for surgical gauze, not non-sterile gauze. We were
able to find the 4x4 non-sterile gauze readily available online at less
than the invoice price. Based on this information, we do not believe
there is enough pricing data to support an increase in the price of the
SG051 supply from $0.03 to $0.04, and we are not proposing an increase
in the price of this supply.
Permanent marking pen (SL477): We received one invoice
from interested parties requesting an increase in the price of the
SL477 supply from $2.81 to $4.62. However, we found black marking pens,
such as Sharpies, widely available at unit prices around $2.00 when
purchased in larger quantities. Based on this information, we do not
believe there is enough pricing data to support an increase in the
price of the SL477 supply from $2.81 to $4.62, and we are not proposing
an increase in the price of this supply.
Hematoxylin II (Ventana 790-2208) (SL483): We received
four invoices from interested parties requesting an increase in the
price of the SL483 supply from $0.780 to $2.722. However, we were able
to find hematoxylin II stains readily available online at cheaper
prices, such as $52.00 for 500 ml ($0.104 per ml). Based on this
information, we do not believe there is enough pricing data to support
an increase in the price of the SL483 supply from $0.780 to $2.722, and
we are not proposing an increase in the price of this supply.
Bluing reagent (Ventana 760-2037) (SL484): We received
three invoices from interested parties requesting an increase in the
price of the SL484 supply from $4.247 to $6.130. While researching the
pricing of the SL484 supply, we were unable to determine the unit
quantity size on invoices, which made it difficult to evaluate if the
requested price accurately reflected market pricing. As best we could
tell, the requested price increase to $6.130 was more expensive than
comparable online bluing reagents available for purchase. Based on this
information, we do not believe there is enough pricing data to support
an increase in the price of the SL484 supply from $4.247 to $6.130, and
we are not proposing an increase in the price of this supply.
EZ Prep (10X) (Ventana 950-102) (SL481) and 250 Test Prep
Kit # 78 (Ventana 786-3034) (SL486): In each of these cases, we
received invoices from interested parties requesting substantial
increases in the price of the associated supplies, from $0.034 to
$0.509 for the SL481 supply and from $0.309 to $2.134 for the SL486
supply. We do not believe that it is reasonable to expect that the
typical market prices for these supplies have increased by 1400 percent
and 600 percent, respectively, in the 5 years since we most recently
updated the pricing for these supplies. The limited pricing information
we could find online for each product also failed to support these
drastic increases in pricing. Based on this information, we do not
believe there is enough pricing data to support the requested increases
for the SL481 and SL486 supplies, and we are not proposing increases to
the prices for these supplies.
(1) Invoice Submission
We remind readers that we routinely accept public submissions of
invoices as part of our process for developing payment rates for new,
revised, and
[[Page 61609]]
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].
In recent years, we have noticed a growing number of invoice
submissions for use in updating supply and equipment pricing. Although
we continue to believe in the importance of using the most recent and
accurate invoice data to reflect current market pricing, we do have
some concerns that the increased use of these submissions may distort
relativity across the fee schedule. Relying on voluntary invoice
submissions to update pricing for a small subset of the total number of
supply and equipment items in our database, while leaving the
overwhelming majority of prices untouched, could be distorting pricing
in favor of the most recent submissions. We believe that it may be more
efficient, and more accurate, to update supply and equipment pricing in
a more comprehensive fashion similar to the pricing update that took
place from CY 2019 to CY 2022. For example, future updates to supply
and equipment pricing could take place in tandem with updates to
clinical labor pricing after the current clinical labor update
concludes in CY 2025. We welcome public comments on this general topic
of more comprehensive updates to supply and equipment pricing, and we
may consider comments we receive to inform future rulemaking.
(2) Supply Pack Pricing Update
Interested parties previously notified CMS that they identified
numerous discrepancies between the aggregated cost of some supply packs
and the individual item components contained within. The interested
parties indicated that CMS should rectify these mathematical errors as
soon as possible to ensure that the sum correctly matches the totals
from the individual items, and they recommended that we resolve these
pricing discrepancies in the supply packs during CY 2024 rulemaking.
The AMA RUC convened a workgroup on this subject and submitted
recommendations to update pricing for a series of supply packs along
with the RUC's comment letter for the CY 2024 rule cycle.
We appreciated the additional information and RUC workgroup
recommendations regarding discrepancies in the aggregated cost of some
supply packs. However, due to the projected significant cost revisions
in the pricing of supply packs and because we did not propose to
address supply pack pricing in the CY 2024 proposed rule, we stated
that this issue would be better addressed in future rulemaking. For
example, the cleaning and disinfecting endoscope pack (SA042) is
included as a supply input in more than 300 HCPCS codes, which could
have a sizable impact on the overall valuation of these services, and
which was not incorporated into the proposed RVUs published for the CY
2024 proposed rule. We stated that interested parties would be better
served if we comprehensively addressed this topic during future
rulemaking in which commenters could provide feedback in response to
proposed pricing updates (88 FR 78833 through 78834).
For CY 2025, we are proposing to implement the supply pack pricing
update and associated revisions as recommended by the RUC's workgroup.
We are proposing to update the pricing of the ``pack, cleaning and
disinfecting, endoscope'' (SA042) supply from $19.43 to $31.29, to
update the pricing of the ``pack, drapes, cystoscopy'' (SA045) supply
from $17.33 to $14.99, to update the pricing of the ``pack, ocular
photodynamic therapy'' (SA049) supply from $16.35 to $26.35, to update
the pricing of the ``pack, urology cystoscopy visit'' (SA058) supply
from $113.70 to $37.63, and to update the pricing of the ``pack,
ophthalmology visit (w-dilation)'' (SA082) supply from $3.91 to $2.33.
As recommended by the RUC workgroup, we are also proposing to delete
the ``pack, drapes, laparotomy (chest-abdomen)'' (SA046) supply
entirely. The proposed updated prices for these supply packs are listed
in the valuation of specific codes section of the preamble under Table
16, CY 2025 Invoices Received for Existing Direct PE Inputs.
In accordance with the RUC workgroup's recommendations, we are also
proposing to create eight new supply codes, including components
contained within previously existing supply packs. Aside from the SB056
supply, which is a replacement in several HCPCS codes for the deleted
SA046 supply pack, all of these new supplies are not included as
standalone direct PE inputs in any current HCPCS codes, as they are,
again, components contained within previously existing supply packs. We
are proposing to add:
The kit, ocular photodynamic therapy (PDT) (SA137) supply
at a price of $26.00 as a component of the SA049 supply pack;
The Abdominal Drape Laparotomy Drape Sterile (100 in x 72
in x 124 in) (SB056) supply at a price of $8.049 as a replacement for
the SA046 supply pack;
The drape, surgical, legging (SB057) supply at a price of
$3.284 as a component of the SA045 supply pack;
The drape, surgical, split, impervious, absorbent (SB058)
supply at a price of $8.424 as a component of the SA045 supply pack;
The post-mydriatic spectacles (SB059) supply at a price of
$0.328 as a component of the SA082 supply pack;
The y-adapter cap (SD367) supply at a price of $0.352 as a
component of the SA049 supply pack;
The ortho-phthalaldehyde 0.55% (e.g., Cidex OPA) (SM030)
supply at a price of $0.554 as a component of the SA042 supply pack;
and
The ortho-phthalaldehyde test strips (SM031) supply at a
price of $1.556 as a component of the SA042 supply pack.
The proposed new supply pack component items are listed in the
valuation of specific codes section of the preamble under Table 17, CY
2025 New Invoices.
We are also proposing the following additional supply substitutions
based on the recommendations of the RUC workgroup. We are proposing to
remove the deleted SA046 supply pack and replace it with the drape,
sterile, fenestrated 16in x 29in (SB011) supply for CPT codes 19020,
19101, 19110, 19112, 20101, and 20102. We are proposing to remove the
deleted SA046 supply pack and replace it with two supplies--the drape,
sterile, three-quarter sheet (SB014) and the drape, towel, sterile 18in
x 26in (SB019)--for CPT codes 19000 and 60300. We are proposing to
remove the deleted SA046 supply pack and replace it with two supplies--
the drape, towel, sterile 18in x 26in (SB019) and the newly created
Abdominal Drape Laparotomy Drape Sterile (100 in x 72 in x 124 in)
(SB056) supply--for CPT codes 22510, 22511, 22513, and 22514. We are
proposing to remove the deleted SA046 supply pack without replacing it
with anything for CPT code 22526; the RUC workgroup
[[Page 61610]]
did not make a recommendation on what to do with CPT code 27278, which
also previously contained the SA046 supply pack. Therefore, we are also
proposing not to replace the SA046 supply pack with any supplies for
this code. The RUC workgroup also recommended removing the SA046 supply
pack from CPT code 64595 with no replacement; however, this code was
recently reviewed at the April 2022 RUC meeting and it no longer
includes the SA046 supply.
The RUC workgroup also reviewed the issue of skin adhesives and
identified several generic alternatives to using the skin adhesive
(Dermabond) (SG007) supply. The workgroup stated that there are
multiple skin adhesive products, at different price points, available
that work similarly to Dermabond and requested that generic
alternatives be used overall in place of brand names in the CMS direct
PE database. The workgroup made a series of suggestions for CMS to
create new medical supply item codes to encompass the generic
formulations of cyanoacrylate skin adhesive in multidose form and
single use sterile application.
We appreciate the recommendations from the RUC workgroup and concur
that generic alternatives be used in place of brand names, where
appropriate, in the CMS direct PE database. However, we have no pricing
information or submitted invoices for the four generic formulations of
cyanoacrylate skin adhesive requested by the RUC workgroup (2-Octyl-
cyanoacrylate, n-Butyl-2-cyanoacrylate, Combined n-Butyl and 2-
Octylcyanoacrylate, and Ethyl-2-cyanoacrylate). Since these four
potential new supplies have no pricing information and are not
currently included as direct PE inputs for any HCPCS codes, we have not
added them to our direct PE database for the CY 2025 proposed rule due
to lack of available information.
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, several 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 updating the
clinical labor pricing was important 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 setting PE RVUs under the PFS. We used the most current BLS
survey data (2019) as the main source of wage data for our CY 2022
clinical labor proposal.
We recognized that the BLS survey of wage data does not cover all
the staff types contained in our direct PE database. Therefore, we
crosswalked or extrapolated the wages for several staff types using
supplementary data sources for verification whenever possible. In
situations where the price wages of clinical labor types were not
referenced in the BLS data, we used the national salary data from the
Salary Expert, an online project of the Economic Research Institute
that surveys national and local salary ranges and averages for
thousands of job titles using mainly government sources. (A detailed
explanation of the methodology used by Salary Expert to estimate
specific job salaries can be found at www.salaryexpert.com.) We
previously used Salary Expert information as the primary backup source
of wage data during the last update of clinical labor pricing in CY
2002. If we did not have direct BLS wage data available for a clinical
labor type, we used the wage data from Salary Expert as a reference for
pricing, then crosswalked these clinical labor types to a proxy BLS
labor category rate that most closely matched the reference wage data,
similar to the crosswalks used in our PE/HR allocation. For example,
there is no direct BLS wage data for the Mammography Technologist
(L043) clinical labor type; we used the wage data from Salary Expert as
a reference and identified the BLS wage data for Respiratory Therapists
as the best proxy category. We calculated rates for the ``blend''
clinical labor categories by combining the rates for each labor type in
the blend and then dividing by the total number of labor types in the
blend.
As in the CY 2002 clinical labor pricing update, the proposed cost
per minute for each clinical staff type was derived by dividing the
average hourly wage rate by 60 to arrive at the per minute cost. In
cases where an hourly wage rate was not available for a clinical staff
type, the proposed cost per minute for the clinical staff type was
derived by
[[Page 61611]]
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 instead of 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 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 clinical labor pricing update implementation over four 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] TP31JY24.003
(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).
(2) CY 2024 Clinical Labor Pricing Updates
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 was 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. Based on comments received on
the CY 2024 proposed rule, we finalized an update in the clinical labor
pricing of the cytotechnologist (L045A) clinical labor type from $0.76
to $0.85 based on submitted data from the 2021 American Society of
Clinical Pathologists (ASCP) Wage Survey of Medical Laboratories (88 FR
78838).
(3) CY 2025 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 2025 PFS proposed rule. Therefore, our proposed
clinical labor pricing for CY 2025 in Table 5 is based on the clinical
labor pricing that we finalized in the CY 2024 PFS final rule,
incremented an additional step for the final Year 4 of the update:
BILLING CODE P
[[Page 61612]]
[GRAPHIC] [TIFF OMITTED] TP31JY24.004
[[Page 61613]]
[GRAPHIC] [TIFF OMITTED] TP31JY24.005
BILLING CODE C
As was the case for the market-based supply and equipment pricing
update, the clinical labor rates will remain open for public comment
during the 60-day comment period for this CY 2025 PFS proposed rule. We
expect to set the updated clinical labor rates for CY 2025 in the final
rule. We updated the pricing of some clinical labor types in the CY
2022, CY 2023, and CY 2024 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).
5. Development of 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 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 (Pub. L. 106-
113, November 29, 1999) (BBRA) 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
through 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 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 through 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
[[Page 61614]]
on strategies to update PE data collection and methodology (87 FR 69429
through 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 reminded
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 previous rulemaking, 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 our CY
2023 and CY 2024 rules 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.
b. Preparation for Incorporating Refreshed Data and Request for
Information on Timing To Effectuate Routine Updates
In the CY 2024 PFS proposed rule, we continued 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. Considering our ratesetting
methodology and prior experiences implementing new data, we issued a
follow-up from the CY 2023 comment solicitation for general
information. We solicited 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 sought 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 the 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 response to last year's RFI, most commenters stated that CMS
should defer significant changes until the AMA PPIS results become
available. For further background, refer to 88 FR 78841 to 78843. In
responding to our RFI, the AMA RUC provided a set of responses, which
many other commenters repeated in their separate, individual comments.
In summary, the AMA RUC letter submission from CY 2024 suggested that
CMS should not consider further changes until PPIS data collection and
analysis is complete. Overall, the AMA comments generally do not
support any change to the methodology and stated that CMS should wait
to consider any further changes until PPIS updates become available.
Further, we noted that through its contractor, Mathematica, the AMA
secured an endorsement for the PPIS updates from each State society,
national medical specialty society, and others prior to fielding the
survey (88 FR 78843). Refer to the AMA's summary of the PPIS, available
at https://www.ama-assn.org/system/files/physician-practice-information-survey-summary.pdf. The AMA expects analysis, reporting,
and documentation to complete by the end of CY 2024, and the AMA would
share data with CMS when results become available.
We believe the AMA's approach may possibly mitigate nonresponse
bias, which created challenges using previous PPIS data. However, we
remain uncertain about whether endorsements prior to fielding the
survey may inject other types of bias in the validity and reliability
of the information collected. We believe it remains important to
reflect on the challenges with our current methodology, and to continue
to consider alternatives that improve the stability and accuracy of our
overall PE methodology. We reiterate our discussion summarizing the
responses to previous years' RFIs in each of the CY 2023 and CY 2024
final rules (refer to 87 FR 69429 through 69432 and 88 FR 78841 to
78843). We have started new work under contract with the RAND
Corporation to analyze and develop alternative methods for measuring PE
and related inputs for implementation of updates to payment under the
PFS. We continue to study possible alternatives, and would include
analysis of updated PPIS data, as part of our ongoing work. In the
meantime, we request general information from the public on ways that
CMS may continue work to improve the stability and predictability of
any future updates. Specifically, we request feedback from interested
parties regarding scheduled, recurring updates to PE inputs for supply
and equipment costs.
We believe that establishing a cycle of timing to update supply and
equipment cost inputs every 4 years may be one means of advancing
shared goals of stability and predictability. CMS would collect
available data, including, but not limited to, submissions and
independent third-party data sources, and propose a phase-in period
over the following 4 years. The phase-in approach maps to our
experience with previous updates. Additionally, we believe that more
frequent updates may have the unintended consequence of
disproportionate effects of various supplies and equipment that have
newly updated costs.
Further, we seek feedback on possible mechanisms to establish a
balance whereby our methodology would account for inflation and
deflation in supply and equipment costs. We remain uncertain how
economies of scale (meaning a general principle that cost per unit of
production decreases as the scale of production increases) should or
should not factor into future adjustments to our methodology. There
remains a diversity of perspectives among interested parties about such
effects. We seek information about specific mechanisms that may be
appropriate, and in particular, approaches that would leverage
verifiable and independent, third-party data that is not managed or
controlled by active market participants.
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
[[Page 61615]]
certain criteria and to review and make appropriate adjustments to the
relative values for those services. Section 1848(c)(2)(L) of the Act
also requires the Secretary to develop a process to validate the RVUs
of certain potentially misvalued codes under the PFS, using the same
criteria used to identify potentially misvalued codes, and to make
appropriate adjustments.
As discussed in section II.E. of this proposed rule, 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 (RBRVS) 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 the Veterans Health Administration (VHA), National Surgical
Quality Improvement Program (NSQIP), the Society for Thoracic Surgeons
(STS), and the Merit-based Incentive Payment System (MIPS) data. In
addition to considering the most recently available data, we assess the
results of physician surveys and specialty recommendations submitted to
us by the RUC for our review. We also consider information provided by
other interested parties such as from the general medical-related
community and the public. We conduct a review to assess the appropriate
RVUs in the context of contemporary medical practice. We note that
section 1848(c)(2)(A)(ii) of the Act authorizes the use of
extrapolation and other techniques to determine the RVUs for
physicians' services for which specific data are not available and
requires us to take into account the results of consultations with
organizations representing physicians who provide the services. In
accordance with section 1848(c) of the Act, we determine and make
appropriate adjustments to the RVUs.
In its March 2006 Report to the Congress (https://www.medpac.gov/document/report-to-the-congress-2006-medicare-payment-policy/), 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 current processes for consideration of
coding changes), which may involve consolidating 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
[[Page 61616]]
misvalued codes established in the CY 2012 PFS final rule with comment
period (76 FR 73026, 73058 through 73059), other individuals and groups
submit nominations for review of potentially misvalued codes as well.
Individuals and groups may submit codes for review under the
potentially misvalued codes initiative to CMS in one of two ways.
Nominations may be submitted to CMS via email or through postal mail.
Email submissions should be sent to the CMS emailbox at
[email protected], with the phrase ``Potentially
Misvalued Codes'' and the referencing CPT code number(s) and/or the CPT
descriptor(s) in the subject line. Physical letters for nominations
should be sent via the U.S. Postal Service to the Centers for Medicare
& Medicaid Services, Mail Stop: C4-01-26, 7500 Security Blvd.,
Baltimore, Maryland 21244. Envelopes containing the nomination letters
must be labeled ``Attention: Division of Practitioner Services,
Potentially Misvalued Codes.'' Nominations for consideration in our
next annual rule cycle should be received by our February 10th
deadline. Since CY 2009, as a part of the annual potentially misvalued
code review and Five-Year Review process, we have reviewed over 1,700
potentially misvalued codes to refine work RVUs and direct PE inputs.
We have assigned appropriate work RVUs and direct PE inputs for these
services as a result of these reviews. A more detailed discussion of
the extensive prior reviews of potentially misvalued codes is included
in the CY 2012 PFS final rule with comment period (76 FR 73052 through
73055). In the same CY 2012 PFS final rule with comment period, we
finalized our policy to consolidate the review of physician work and PE
at the same time and established a process for the annual public
nomination of potentially misvalued services.
In the CY 2013 PFS final rule with comment period (77 FR 68892,
68896 through 68897), we built upon the work we began in CY 2009 to
review potentially misvalued codes that have not been reviewed since
the implementation of the PFS (so-called ``Harvard-valued codes'' \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 2025 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, their
associated organization, and the submitted studies 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 2025, we received 5 nominations concerning
various codes. The nominations are as follows:
(1) CPT Codes 22210, 22212, 22214, 22216
An interested party nominated CPT codes 22210 (Osteotomy of spine,
posterior or posterolateral approach, 1 vertebral segment; cervical)
(090 day global code), 22212 (Osteotomy of spine, posterior or
posterolateral approach, 1 vertebral segment; thoracic) (090 day global
code), 22214 (Osteotomy of spine, posterior or posterolateral approach,
1 vertebral segment; lumbar) (090 day global code), and 22216
(Osteotomy of
[[Page 61617]]
spine, posterior or posterolateral approach, 1 vertebral segment; each
additional vertebral segment (List separately in addition to primary
procedure) (add-on ZZZ) as potentially misvalued for six reasons: (1)
incorrect global period; (2) incorrect inpatient days; (3) incorrect
intraservice work description; (4) overvalued intraservice times; (5)
changed surgical practice; and (6) incorrect use of posterior osteotomy
codes. The posterior osteotomy codes were last valued by the RUC in
1995. Currently, CPT code 22210 has a work RVU of 25.38, CPT code 22212
has a work RVU of 20.99, CPT code 22214 has a work RVU of 21.02, and
CPT code 22216 has a work RVU of 6.03. CPT codes 22210, 22212, and
22214 have 7 inpatient days each, while CPT code 22216 has 0 inpatient
days, and it is an add-on code.
First, the nominator stated that these posterior osteotomies are
always performed as an optional addition to a spinal fusion and should
be valued as add-on services and not as 90-day global services. We note
that no references are provided to support the statement that the
service is always performed as an optional addition to a spinal fusion.
Second, the nominator explained that the average hospital stay for
scoliosis fusion with osteotomy is 4 to 5 days according to the current
literature,2 3 4 in contrast with the currently included 7
inpatient days. We note that the majority of the medical literature
submitted by the nominator presented outcome information on adolescent
patients, which may be different from the Medicare population.
Furthermore, the nominator stated that the intraservice work
description for CPT code 22216 describes removal of the pedicle, which
is not a typical part of a Ponte/Schwab II osteotomy. Among the
posterior osteotomy codes, only CPT code 22216 had vignettes and we do
not have information to decide whether the code descriptor is correct.
We believe this issue would benefit from further review by the medical
community and welcome comments and considerations, including from the
AMA CPT.
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\2\ Halanski, Matthew Aaron, and Jeffrey A Cassidy. ``Do
multilevel Ponte osteotomies in thoracic idiopathic scoliosis
surgery improve curve correction and restore thoracic kyphosis?''
Journal of spinal disorders & techniques vol. 26,5 (2013): 252-5.
doi:10.1097/BSD.0b013e318241e3cf.
\3\ Floccari, Lorena V et al. ``Ponte osteotomies in a matched
series of large AIS curves increase surgical risk without improving
outcomes.'' Spine deformity vol. 9,5 (2021): 1411-1418. doi:10.1007/
s43390-021-00339-x.
\4\ Buckland, Aaron J et al. ``Ponte Osteotomies Increase the
Risk of Neuromonitoring Alerts in Adolescent Idiopathic Scoliosis
Correction Surgery.'' Spine vol. 44,3 (2019): E175-E180.
doi:10.1097/BRS.0000000000002784.
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The nominator also asserted that intraservice times were too high,
particularly for these osteotomy services furnished with scoliosis
fusion procedures. The nominator explained that a typical scoliosis
fusion would be billed with an intraservice time of up to 840 minutes
for pediatric scoliosis fusion and 915 minutes for adult cases.
However, referencing current literature, they observed that a typical
scoliosis fusion in a child requires approximately 278 minutes (243-296
minutes),5 6 7 which contrasts significantly with the
durations indicated for the current codes. The nominator provided no
studies to support a typical scoliosis fusion time in adults. Drawing
from the literature, the nominators assert that intraservice times are
overvalued for these services and propose that these times should be
adjusted to align more closely with average and/or typical surgery
times.
---------------------------------------------------------------------------
\5\ Samdani, Amer F et al. ``Do Ponte Osteotomies Enhance
Correction in Adolescent Idiopathic Scoliosis? An Analysis of 191
Lenke 1A and 1B Curves.'' Spine deformity vol. 3,5 (2015): 483-488.
doi:10.1016/j.jspd.2015.03.002.
\6\ Pizones, Javier et al. ``Ponte osteotomies to treat major
thoracic adolescent idiopathic scoliosis curves allow more effective
corrective maneuvers.'' European spine journal: official publication
of the European Spine Society, the European Spinal Deformity
Society, and the European Section of the Cervical Spine Research
Society vol. 24,7 (2015): 1540-6. doi:10.1007/s00586-014-3749-1.
\7\ Feng, Jing et al. ``Clinical and radiological outcomes of
the multilevel Ponte osteotomy with posterior selective segmental
pedicle screw constructs to treat adolescent thoracic idiopathic
scoliosis.'' Journal of orthopaedic surgery and research vol. 13,1
305. 29 Nov. 2018, doi:10.1186/s13018-018-1001-0.
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The nominator further asserted that this code family is potentially
misvalued because surgical practice for these procedures has evolved
since 1995. Approximately 30 years ago, osteotomies were infrequently
performed and usually reserved for addressing completely ankylosed or
fused spinal segments.\8\ However, according to the nominator,
contemporary surgical techniques often involve posterior osteotomies to
release multiple stiff vertebral segments, thereby enhancing coronal
correction and reducing thoracic hypokyphosis. In addition to changes
in surgical techniques over time, there are notable shifts in the
trends regarding the utilization of osteotomies. For instance, between
2007 and 2015, the use of posterior osteotomies in scoliosis cases
nearly doubled, increasing from 17 percent to 35 percent.\9\
Additionally, 73 percent of patients undergoing scoliosis surgery
received posterior osteotomies.\4\ This information supports the
nominator's assertion that there have been notable changes in the
surgical practice for these codes over time.
---------------------------------------------------------------------------
\8\ Ponte, Alberto et al. ``The True Ponte Osteotomy: By the One
Who Developed It.'' Spine deformity vol. 6,1 (2018): 2-11.
doi:10.1016/j.jspd.2017.06.006.
\9\ Shaheen, Mohammed et al. ``Complication risks and costs
associated with Ponte osteotomies in surgical treatment of
adolescent idiopathic scoliosis: insights from a national
database.'' Spine deformity vol. 10,6 (2022): 1339-1348.
doi:10.1007/s43390-022-00534-4.
---------------------------------------------------------------------------
Lastly, the nominator highlighted incorrect usage of posterior
osteotomy codes. They noted instances where facet/soft tissue releases,
such as Schwab type I osteotomies, are inaccurately reported with these
codes. According to the nominator, isolated partial facetectomy and
soft tissue release are already included in spinal fusion procedures
and should not be separately billed with an osteotomy code.
Additionally, CMS in reviewing data for these services identified
potential bundling of services within this code family. For instance,
CPT code 22210 is frequently billed alongside CPT code 22600
(Arthrodesis, posterior or posterolateral technique, single interspace;
cervical below C2 segment) (090-day global code), approximately 83
percent of the time. This indicates a common billing pattern,
suggesting potential for coding revisions, including the consideration
of consolidating individual services into bundled codes. Overall, based
on the six reasons provided by the nominator, along with the fact that
these codes were last valued almost 30 years ago, and given the
identified billing practices, we concur that CPT codes 22210, 22212,
22214, and 22216 are potentially misvalued. The nominator suggested two
options to address this concern: (1) developing add-on codes to
differentiate between the number of vertebral segments involved in the
osteotomy procedure and whether it occurs in the cervical, thoracic, or
lumbar regions; and (2) removing the current posterior osteotomy codes
and incorporating osteotomies into new deformity fusion codes, both
with and without osteotomy. We are proposing to consider this code
family as potentially misvalued and we appreciate the detailed
information submitted by the nominator with sufficient supporting
evidence. We believe that this code family would benefit from a
comprehensive review by the RUC, and we welcome comments on a broader
understanding of these codes. Additionally, we seek input on current
standard billing practices. For example, information on whether the
standard of
[[Page 61618]]
practice has evolved over time, and if so, how it has evolved, could
aid in identifying potential coding issues related to this matter.
(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 re-nominated as
potentially misvalued based on the absence of separate direct PE inputs
for this 090 day global code in the nonfacility setting. Currently, CPT
code 27279 is only priced under the PFS in the facility setting, but
the nominator is requesting that we establish separate direct PE inputs
for this service to value the service when performed in the
nonfacility/office setting (for example, in an office-based lab). The
nominator stated that establishing payment for direct PE inputs in the
nonfacility/office setting would increase access to this service for
Medicare patients.
We did not nominate CPT code 27279 as potentially misvalued in the
CY 2024 PFS final rule, mainly due to a lack of consensus on whether
these services may be safely and effectively furnished in the
nonfacility/office setting. In this year's submission, the nominator
provided three post-market surveillance publications and two
independent reviews of minimally invasive sacroiliac (SI) joint fusion
procedures to support their assertion that this 90-day surgical service
could be safely and effectively furnished in the nonfacility/office
setting. Based on the studies, the nominator stated that the current
medical literature provides evidence supporting the conclusion that
percutaneous or minimally invasive SI joint arthrodesis (CPT code
27279) carries a complication rate that is acceptably low, comparable
to other spinal procedures commonly performed in the office-based lab
(OBL). For instance, the risk of major complications during lateral
trans iliac (LTI) SI joint fusion (CPT code 27279) is lower than the
risks associated with other OBL procedures. These include the risk of
iliac perforation during angioplasty, the risk of death, myocardial
infarction (MI), and stroke during diagnostic cardiac catheterization.
The nominator did not reference literature regarding the rates of major
complications for other OBL procedures in their submission.
Based on the information submitted we recognize the possibility
that CPT code 27279 may be potentially misvalued, given the nominator's
assertion that its complication rate is acceptably low based on the
five studies they submitted. The results of the studies may suggest
that CPT code 27279 can be safely performed in the office-based lab
setting, as asserted by the nominator, with a relatively low
complication rate. However, upon reviewing the submitted information,
we also note that these studies collectively report heterogeneous
safety outcomes. The large variabilities in safety outcomes reported in
the studies, coupled with several unreported outcomes, may indicate
that we have little knowledge about the effect of the service on safety
outcomes, prompting the need for further investigation. Therefore, we
are not proposing to consider this code as potentially misvalued, and
we are instead seeking comments and additional studies from the broader
medical community regarding whether this code should be priced under
the PFS for the non-facility/office setting.
(3) CPT code 95800
An interested party re-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) to update practice expenses that were last reviewed in
2017. This code was nominated as potentially misvalued in the CY 2024
PFS proposed rule (88 FR 52283). For the CY 2024 final rule, we stated
that we were unable to properly assess whether CPT code 95800 is
potentially misvalued based on the evidence submitted with the original
nominations and subsequent comments that CMS received (88 FR 78849-
78850). This year, an interested party re-nominated CPT code 59800
noting two significant changes: (1) in the technologies available to
perform home sleep apnea testing (HSAT) services; and (2) in clinical
practice that leads to the typical procedure reported with the CPT code
95800. According to the nominator, the current practice utilizes
disposable HSAT technology, such as the WatchPat One device, more often
than the reusable equipment currently included in the procedure's
direct practice expense (PE) inputs.
To account for these changes, the nominator requested the deletion
of three direct PE input codes: (1) equipment code EQ335 (WatchPAT 200
Unit with strap, cables, charger, booklet, and patient video); (2)
equipment code EQ336 (Oximetry and Airflow Device); and (3) supply code
SD263 (WatchPAT pneumo-opt sleep probes), which are WatchPAT probes
used with the reusable WatchPAT unit. Instead, the nominator requested
the addition of a supply code SD362 (the WatchPAT ONE device), a
disposable HSAT technology, as a replacement. According to our PE
supply list, the combined price of the items that the nominator
requested to delete (EQ335, EQ336, and SD263) is $4.71 + $4.55 + $73.32
= $82.58, which is $15.62 less than the price of the item that the
nominator requested to add (SD362), priced at $98.20. The price of
$98.20 is mentioned in the nomination letter without an accompanying
specific invoice. Last year, the nominator submitted invoices, showing
a price of $99.00 each (a case of 12 totaling $1,188.00) for the
WatchPat One Device (SD362) (see Table 6).
[[Page 61619]]
[GRAPHIC] [TIFF OMITTED] TP31JY24.006
The nominator asserted that testing trends have shifted away from
traditional airflow-based tests, with a noticeable rise in peripheral
arterial tone (PAT)-based (non-airflow) tests. The traditional airflow-
based tests use the reusable supplies and equipment, whereas the PAT-
based non-airflow tests use the disposable HSAT device. While
describing these changes in trends, the nominator did not provide us
with their internal data, thus we are unable to verify its validity.
The nominator also stated that disposable HSAT devices were used for
nearly 50 percent of CPT code 95800 services in 2023 and attributed the
increased use of disposable devices to the COVID-19 public health
emergency (PHE). Furthermore, the nominator projected that over 50
percent of CPT code 95800 services will be furnished using disposable
devices in 2024 and 2025. Explaining the patterns and predictions, the
nominator concluded that the pandemic significantly altered the
delivery of HSAT services, with many sleep physicians transitioning to
single-use, disposable sleep tests as an alternative to the reusable
testing equipment that is shipped from patient-to-patient after post-
use cleaning. The nominator believes that, going forward, the typical
procedure described by CPT code 95800 in CY 2024 and beyond will be
furnished using disposable HSAT devices rather than reusable equipment.
Since the COVID-19 PHE ended in 2023, we are still unclear as to
whether the typical procedure reported with CPT code 95800 involves the
use of a reusable or disposable HSAT device. Given that we only have
access to the nominator's summary of their internal data to observe
changes in usage trends, which may not be generalizable, we propose to
maintain the current direct PE supply and equipment inputs for CPT code
95800. While we are not currently proposing to review CPT code 95800 as
potentially misvalued for CY 2025, we seek public comments on this
nomination. In particular, we seek comments on whether the typical
procedure described by CPT code 95800 now involves the use of a
disposable HSAT device rather than reusable equipment.
(4) CPT codes 10021, 10004, 10005, 10006
An interested party nominated the CPT code 10021 (Fine needle
aspiration biopsy, without imaging guidance; first lesion), CPT code
10004 (Fine needle aspiration biopsy, without imaging guidance; each
additional lesion), CPT code 10005 (Fine needle aspiration biopsy,
including ultrasound guidance; first lesion) and CPT code 10006 (Fine
needle aspiration biopsy, including ultrasound guidance; each
additional lesion) as potentially misvalued. We note that this code
family has been nominated several times in recent years. We discussed
our review of these codes and our rationale for finalizing the current
values extensively in the CY 2019 PFS final rule (83 FR 59517), and CY
2021 PFS final rule (85 FR 84602). Furthermore, this code family was
nominated as potentially misvalued and discussed in the CY 2020 PFS
final rule (84 FR 62625). For more information we encourage the
interested parties to go to our previous PFS final rules.
The nominator specifically requested that we revisit our work RVU
decisions for these codes, stating that the underpinnings of the
reduction in work RVUs from the RUC-recommended values were flawed. The
nominator suggested that CMS should adopt the RUC-recommended work
RVUs. For CPT code 10021, the RUC recommended a work RVU of 1.20, but
we adopted a lower value of 1.03. Similarly, for CPT code 10005, the
RUC recommended a work RVU of 1.63, but we adopted 1.46. The nominator
disagreed with these reductions from the RUC-recommended values by CMS,
raising particular concerns about our choice for the RVU crosswalk for
CPT code 36440 (Push blood transfusion, patient 2 years or younger).
According to the nominator, the CPT code we chose is not comparable to
fine needle aspiration in any respect other than service time. The
nominator raised several points, including that CPT code 36440 is
rarely utilized and is almost never billed to Medicare because it
pertains to a pediatric procedure conducted on neonates, while CPT code
10021 is never performed on neonates. They further asserted that the
training and experience levels required to properly perform these
procedures differ significantly; neonatal transfusions can be conducted
by less experienced personnel, while performing a thyroid fine needle
aspiration demands more experience. Specifically, they argued that
there is a notable difference in the work intensity between the two
procedures. The thyroid is closely positioned to vital structures such
as the carotid artery, jugular vein, lymphatic vessels, nerves,
trachea, and esophagus. When sampling thyroid nodules, they are often
in proximity to the carotid artery, jugular vein, or both. According to
the nominator, even a slight deviation of 1-2 millimeters during the
sampling procedure can result in accidental puncture of these critical
blood vessels or other nearby structures. Factors such as respiratory
movements, patient swallowing, or anxiety may cause the thyroid to
move, further increasing the
[[Page 61620]]
risk during the procedure. In contrast, neonatal phlebotomy does not
require such measures. Also, the CPT code 36440 is designated as
facility-only, meaning it does not include any clinical staff pre-
service time and has no associated practice expense inputs. According
to the nominator, fine needle aspiration is a very complex and high-
risk procedure that may require significant physician work and a higher
level of clinical expertise to furnish the service, which is very
different from CPT code 36440. We appreciated the survey (N=74) results
that the nominator submitted to support their statements. The
nominator-conducted survey, and their survey questions aimed to gather
information on the practitioners' experiences, opinions, and practices
related to fine needle aspiration procedures. However, no other
references such as peer reviewed medical literature or other nationally
representative survey data were provided to reinforce their argument.
The nominator further stated that thyroid fine needle aspiration
should exclusively be performed as an outpatient procedure and does not
require hospitalization. The nominator emphasized that the reduction in
payment for the code family due to the reduction in work RVUs from the
RUC-recommended values has led endocrinologists in office-based
practices, those who are not affiliated with facilities, to discontinue
furnishing this service. According to the nominator, as a consequence
of this payment decrease, patients are now being referred to hospital-
based radiology practices, despite the fact that thyroid fine needle
aspiration should ideally be conducted exclusively in nonfacility
outpatient settings. The nominator asserted that radiologists in
hospital settings are often unfamiliar with the patient's medical
history and risk factors for suspected thyroid cancer. The nominator
further noted that radiologists' training in thyroid cancer primarily
emphasizes imaging and procedures, rather than considering the
patient's overall health perspective. This result may further lead to
an increase in medically unnecessary procedures. Additionally, the
nominator believes that the payment reduction for this code family has
the potential to diminish the specialist workforce trained to perform
these procedures, thereby presenting future challenges in patient care
and access to specialized services.
Overall, we appreciate the comprehensive information and level of
detail provided by the nominator. The nominator disagreed with the
choice of crosswalk CPT code 36440 made by CMS, emphasizing the
differences in provider training, procedure risk, and patient
population. They noted the rarity of Medicare billing for this code.
Additionally, they emphasized the importance of outpatient thyroid fine
needle aspiration being performed by endocrinologists. The shift to
facility settings, prompted by reduced work RVUs, could raise Medicare
costs. This, along with a potential decline in specialist workforce,
may hinder patient access. However, in discussing this group of codes,
we must note that these codes have been recently reviewed multiple
times through the annual PFS rulemaking process. We would like to
clarify once again that we disagree with the nominator that this code
family is potentially misvalued. We acknowledge the possibility that
there could be significant changes in the practice of delivering
services described by these codes that were not fully reflected in the
current work RVU. In such cases, it would be appropriate to refer the
codes to the RUC to conduct a new survey to capture these changes
accurately. However, we note that these codes underwent thorough RUC
survey and review processes during the October 2017 and January 2018
RUC meetings. Based on these considerations, we disagree with the
assertion that this code family is potentially misvalued. Nevertheless,
we welcome comments on whether these codes should be re-reviewed in
light of the arguments made by the nominator.
(5) Tympanostomy codes
CMS routinely interacts with interested parties, and in our most
recent review, we have observed several new devices that could be
beneficial for populations but are not currently included in our coding
system. While there are variations in the described devices, they
commonly share the following descriptions. This device uses an
innovative surgical technology that combines the separate functions of
creating a myringotomy (incision in the eardrum), and positioning and
placing a ventilation tube across the tympanic membrane. The new device
is intended to deliver a tympanostomy tube (also referred to as a
ventilation tube) through the tympanic membrane of the patient and is
indicated to be used in office settings for pediatric patients 6 months
and older. This device allows the tympanostomy service to be furnished
to patients without general anesthesia and the service could therefore
be performed in the office setting.
Regarding the delivery of this service using innovative surgical
technology, CMS recognizes that CPT code 69433 (Tympanostomy (requiring
insertion of ventilating tube), local or topical anesthesia) (010-day
global code) may serve as a sufficient base code, adequately describing
the majority of the surgeon's work and facility resources. However, a
practitioner may incur additional resources, due to the higher expected
intraservice work driven by both time and intensity factors, especially
when furnishing a service to a child, and the cost of the device when
using these devices as part of the performed procedure. While the
existing CPT code 69433 is not age-specific, both the vignette and the
RVU associated with this procedure are established for adult patients
who can respond to surgeon direction, and do not have risk of movement
during the procedure. We believe that potentially establishing
additional coding and payment for tympanostomy services may enable the
provision of these services utilizing new technologies to a broader
patient population who may benefit from innovative surgical technology.
To improve the accuracy of the payment for these services, we are
soliciting comments on several alternatives that we are considering for
adoption in the CY 2025 PFS final rule or future rulemaking. First, we
are seeking comment on whether to establish a new G code that accounts
for the work and practice expense for a procedure involving the
positioning and placement of a ventilation tube across the tympanic
membrane using an innovative surgical technology that combines the
separate functions of creating a myringotomy (incision in the eardrum).
We could assign contractor pricing to this potential G code for
generalizable innovative tympanostomy tube delivery devices and/or
systems falling under emerging technology and services categories.
Alternatively, we are seeking comment on whether we should establish an
add-on payment for the service using inputs from CPT code 69433 as a
crosswalk reference, plus direct costs from invoices for the surgical
devices referenced above. We are seeking comments regarding these
potential approaches, particularly on whether there is additional
information we should consider if we were to establish additional
coding and payment for these services.
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
[[Page 61621]]
further details and full discussion of the scope of Medicare telehealth
services in the CY 2018 PFS final rule (82 FR 53006), the CY 2021 PFS
final rule (85 FR 84502) and the CY 2024 PFS final rule (88 FR 78861
through 78866) and in 42 CFR 410.78 and 414.65. For a discussion of
Telemedicine Evaluation and Management (E/M) Services, we refer readers
to section II.E.4.18 of this proposed rule.
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. 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. Under the process we established
beginning in CY 2003, we evaluated whether a service meets the
following criteria:
Category 1: Services similar to professional
consultations, office visits, and office psychiatry services currently
on the Medicare Telehealth Services List. In reviewing these requests,
we looked 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 was present
with the beneficiary in the originating site. We also looked 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
included assessing whether the service was accurately described by the
corresponding code when furnished via telehealth and whether using a
telecommunications system to furnish the service produces demonstrated
clinical benefit to the patient. Submitted evidence should have
included both a description of relevant clinical studies that
demonstrated 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 did not include minor or incidental
benefits. Some examples of other clinical benefits that we considered
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.
In the CY 2021 PFS final rule (85 FR 84507), we created a third
category of criteria for adding services to the Medicare Telehealth
Services List on a temporary basis following the end of the PHE for the
COVID-19 pandemic. This new category described services that were added
to the Medicare Telehealth Services List during the PHE, for which
there was likely to be clinical benefit when furnished via telehealth,
but there was 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 ultimately
needed 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 would conduct a clinical
assessment to identify those services for which we could foresee a
reasonable potential likelihood of clinical benefit when furnished via
telehealth.
In the CY 2024 PFS final rule (88 FR 78861 through 78866), we
consolidated these three categories and implemented a revised 5-step
process for making additions, deletions, and changes to the Medicare
Telehealth Services List (5-step process), beginning for the CY 2025
Medicare Telehealth Services List. Rather than categorizing a service
as ``Category 1'' or ``Category 2,'' each service is now assigned a
``permanent'' or ``provisional'' status. As described further below, a
service is assigned a ``provisional'' status if there is not enough
evidence to demonstrate that the service is of clinical benefit, but
there is enough evidence to suggest that further study may demonstrate
such benefit. The 5-step process review criteria are set forth in the
CY 2024 PFS final rule (88 FR 78861 through 78866), listed at https://www.cms.gov/medicare/coverage/telehealth/criteria-request, and
summarized below. Consistent with the deadline for our receipt of code
valuation recommendations from the American Medical Association's
Relative Value Scale Update Committee (AMA RUC) and other interested
parties (83 FR 59491) and with the process set forth in prior calendar
years, for CY 2025, requests to add services to the Medicare Telehealth
Services List must have been submitted to and received by CMS by
February 10, 2024. 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 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 to add services to the Medicare Telehealth
Services List, including where to send these requests, and to view the
current Medicare Telehealth Service List, see our website at https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/.
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 first determine
whether the service, as described by the individual HCPCS code, is
separately payable under the PFS because, as further discussed in CY
2024 PFS final rule (88 FR 78861 through 78866), Medicare telehealth
services are limited to those services for which separate Medicare
payments can be made under the PFS. Before gathering evidence and
preparing to submit a request to add a service to the Medicare
Telehealth Services List, the submitter should therefore 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).
Step 2. Determine whether the service is subject to the provisions
of section 1834(m) of the Act.
[[Page 61622]]
If we determine at Step 1 that a service is separately payable
under the PFS, we apply Step 2 under which we determine whether the
service at issue is subject to the provisions of section 1834(m) of the
Act. Section 1834(m) of the Act provides for payment to a physician (or
other 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 have historically interpreted this to
mean that only services that are ordinarily furnished with the
furnishing practitioner and patient in the same location can be
classified as a ``telehealth service'' for which payment can be made
under section 1834(m) of the Act. Given that there may be a range of
services delivered using certain telecommunications technology that,
though they are separately payable under the PFS, do not fall within
the definition of telehealth service set forth in section 1834(m) of
the Act, the aim of Step 2 is therefore to determine whether the
service at issue is, in whole or in part, inherently a face-to-face
service. 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 therefore review during this Step 2
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.
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).
Step 3 is corollary to Step 2, and is 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 requesters 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 clinical actions, or patient interaction, would not
be of similar content as an in-person visit, or could not be completed.
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 Step 4 is to simplify and reduce the administrative
burden of submission and review. For Step 4, we review 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 is assigned
permanent status. Any code that satisfies this criterion would require
no further analysis. If the service elements of a code maps to the
service elements of a code that is already included on the Medicare
Telehealth Services List and is assigned permanent basis, we will add
the code to the Medicare Telehealth Services List and assign it
permanent status. While we have not previously found that the service
elements of a code we are considering for addition to the list map to
the elements of a service that was previously added to the list and
assigned permanent basis, we believe that it is 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. When Step 4 is
met, further evidence review is not necessary. We continue to Step 5 if
Step 4 is not met.
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 Step
5, we review the evidence provided with a submission to determine the
clinical benefit of a service. We 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. If there is enough
evidence to suggest that further study may demonstrate that the
service, when provided via telehealth, is of clinical benefit, CMS will
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 will 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 reminded readers that our evidentiary
standard of demonstrated clinical benefit does not include minor or
incidental benefits (81 FR 80194). We 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. General evidence
may also answer the question of whether a certain 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
[[Page 61623]]
reflecting practitioner services furnished to Medicare beneficiaries
are helpful in our considerations.
b. Requests To Add Services to the Medicare Telehealth Services List
for CY 2025
We received several requests to permanently add various services to
the Medicare Telehealth Services List, effective for CY 2025. The
requested services are listed in Table 7.
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Many services were added to the Medicare Telehealth Services List
on a temporary basis as discussed in the March 31st COVID-19 interim
final rule with comment period (IFC) (85 FR 19235 through 19237) for
the PHE for Covid-19, and we subsequently retained these services on a
provisional basis. All of the received submissions were requests for
addition on a permanent basis. We believe that, rather than selectively
adjudicating only those services for which we received requests for
potential permanent status, it would be appropriate to complete a
comprehensive analysis of all provisional codes currently on the
Medicare Telehealth Services List before determining which codes should
be made permanent. We are therefore not making determinations to
recategorize provisional codes as permanent until such time as CMS can
complete a comprehensive analysis of all such provisional codes which
we expect to address in future rulemaking.
The following is a discussion of the requests received for addition
of services to the Medicare Telehealth Services List:
(1) Continuous Glucose Monitoring
We received a request to add CPT code 95251 (Ambulatory continuous
glucose monitoring of interstitial tissue fluid via a subcutaneous
sensor for a minimum of 72 hours; analysis, interpretation and report)
to the Medicare Telehealth Services List and assign it permanent
status. This code is not on the Medicare Telehealth Services List, nor
had it been previously added and removed. The requester stated that the
ability of the practitioner to interpret continuous glucose monitoring
data and communicate changes in the diabetes care plan to our patients
is enhanced by the availability of video visits, and the code should
therefore be added to the Medicare Telehealth Services List. This
service does not meet the criteria described by Step 2 of the 5-step
process: determination of whether the service is subject to the
provisions of section 1834(m) of the Act. Section 1834(m) of the Act
limits the definition of Medicare telehealth services to those services
that would ordinarily be furnished with the furnishing practitioner and
patient in the same location (88 78863). In other words, as stated
above, for a service to be considered a Medicare telehealth service
subject to and payable under section 1834(m) of the Act, the service
must be so analogous to in-person care such that the telehealth
service, as defined in Sec. 410.78, is essentially a substitute for a
face-to-face encounter. We do not consider this service a Medicare
telehealth service because it is not an inherently face-to-face
service; the patient does not need to be present for the service to be
furnished in its entirety. CPT code 95251 describes sensor placement
and monitoring over a 72-hour period. We do not consider CPT code 95251
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.
(2) Cardiovascular and Pulmonary Rehabilitation
We received requests to permanently add cardiovascular
rehabilitation services (CPT codes 93797 and 93798) and pulmonary
rehabilitation services (CPT codes 94625 and 94626) to the Medicare
Telehealth Services List. These services are currently on the Medicare
Telehealth List and are assigned provisional status. We had originally
added CPT codes 93797 and 93798 and HCPCS codes G0422 and G0423 on a
temporary basis in the CY 2022 PFS final rule (FR 86 65054 through
65055). A requester cited studies that they say demonstrate that the
availability of these services via telehealth enhances access and
patient equity. Another requester cited evidence of improved outcomes
for patients that had access to these services via telehealth. As
explained previously, we are not proposing to revise the status of
codes from provisional to permanent in this proposed rule because we
intend to conduct a comprehensive review. While considering these
issues for future rulemaking, we are not proposing to assign CPT codes
93797 and 93798 or CPT codes 94625 and 94626 permanent status on the
Medicare Telehealth Services List and would instead maintain the
services on the Medicare Telehealth Services List on a provisional
basis for CY 2025.
(3) Health and Well Being-Coaching
We received a request to add Health and Well-Being Coaching (CPT
codes 0591T-0593T) to the Medicare Telehealth Services List with
permanent status. These services are currently on the Medicare
Telehealth Services List and are assigned a provisional status. We
originally added these codes on a provisional basis in the CY 2024 PFS
final rule (FR 88 78859 and 78860). One requester stated that health
and well-being coaching, including content education, delivered in a
telehealth modality is an evidence-based, cost-
[[Page 61626]]
effective, sustainable, and common sense approach to facilitating
lifestyle/behavioral intervention and treating the Medicare population
with or at heightened risk for chronic diseases. As explained
previously, we are not proposing to revise the status of codes from
provisional to permanent in this proposed rule because we intend to
conduct a comprehensive review. Therefore, we are not proposing to
assign them to the Medicare Telehealth Services List with permanent
status.
(4) Psychological Testing and Developmental Testing
We received a request to add Psychological Testing and
Developmental Testing (CPT codes 96112, 96113, 96130, 96136, and 96137)
to the Medicare Telehealth Services List on a permanent basis. These
services are currently on the Medicare Telehealth Services List and are
assigned provisional status. In the March 31, 2020 interim final rule
with comment period (IFC-1) (85 FR 19239), we originally added CPT
codes 96130, 96136, and 96137 to the Medicare Telehealth Services List
for the duration of the PHE for COVID-19, and in the CY 2021 PFS final
rule (85 FR 85003), we stated we were retaining them on the list on a
category 3 basis. In the CY 2023 PFS final rule (87 FR 69460), we added
CPT codes 96112 and 96113 on a temporary basis.
As explained previously, we are not proposing to revise the status
of codes from provisional to permanent in this proposed rule because we
intend to conduct a comprehensive review. Therefore, we are not
proposing to either remove these services from or to assign them
permanent status on the Medicare Telehealth Services List.
(5) Therapy/Audiology/Speech Language Pathology
We received multiple requests to add the Therapy services described
by CPT codes 97110, 97112, 97116, 97161 through 97164, 97530 and 97535,
97165 through 97168, and Audiology and Speech Language Pathology
services CPT codes 92507, 92508, 92521 through 92524, 92526, 92607
through 92610, 96105 92626, 92627, 96125, 97129, 97130, 92607 through
92609 92550 through 92557, 92563, 92565 92567, 92568, 92570, 92587,
92588, 92601 through 92604, 92625 through 92627, and 92651 and 92652 to
the Medicare Telehealth Services List on a permanent basis stating that
continuing Telehealth flexibilities for these services could lead to
reduced health care expenditures, increased patient access, and
improved management of chronic disease and quality of life. These
services are currently available on the Medicare Telehealth Services
List and are assigned provisional status, and we refer readers to
section II.D.1. for further discussion of these services. In the CY
2023 PFS final rule (87 FR 69451), we originally added CPT codes 90901,
97150, 97530, 97537, 97542, 97763, and 98960-98962 to the Medicare
Telehealth Services List on a Category 3 basis. As explained
previously, we are not proposing to revise the status of codes from
provisional to permanent in this proposed rule because we intend to
conduct a comprehensive review. Therefore, we are not proposing to
assign them permanent status on the Medicare Telehealth Services List.
(6) Care Management
We received a request to permanently add General Behavioral Health
Integration (CPT code 99484) and Principal Care Management (CPT codes
99424-99427) to the Medicare Telehealth Services List. These services
are not on the Medicare Telehealth Services List, nor have they been
previously added and removed. These services do not meet the criteria
described by Step 2 of the 5-step process: determination of whether the
service is subject to the provisions of section 1834(m) of the Act. As
stated above, 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 (88 78863), and for a
service to be considered a telehealth service subject to and payable
under section 1834(m) of the Act, the service must be so analogous to
in-person care such that the telehealth service, as defined in Sec.
410.78, is essentially a substitute for a face-to-face encounter. We do
not consider these services to be Medicare telehealth services because
they are not inherently face-to-face services, and the patient need not
be present for the services to be furnished in its entirety. Therefore,
we do not consider CPT codes 99484 and 99424-99427 to be telehealth
services 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.
(7) Posterior Tibial Nerve Stimulation for Voiding Dysfunction
We received a request to permanently add Posterior tibial
neurostimulation (CPT code 64566) to the Medicare Telehealth Services
List. This code is not on the Medicare Telehealth Services List, nor
had it been previously added and removed. This service does not meet
the criteria for addition described by Step 3 of the 5-step process,
namely the 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). The requestor describes the services underlying CPT code
64566 as the continual or recurring treatments over a period of time
consisting of the remote monitoring of device utilization and bladder
diary for the generation of reports for review by the care provider.
Based on our review, this description does not align with the elements
of the service as described by CPT code 64566. CPT code 64566 describes
a single treatment provided by a clinician who has direct contact with
the patient and inserts an electrode into the skin overlying the
posterior tibial nerve. Upon conclusion of the treatment, the clinician
removes the electrode and examines and dresses the puncture wound.
Providing these services would require in-person interaction. We are
therefore not proposing to add the service to the Medicare Telehealth
Services List because we do not believe the service elements can be met
in full using two-way audio-video telecommunications technology.
(8) Radiation Treatment Management
We received requests to permanently add Radiation Treatment
Management (CPT code 77427) to the Medicare Telehealth Services List.
The code is currently on the Medicare Telehealth List with provisional
status. In the March 31, 2020 IFC (85 FR 9240), we originally added CPT
code 77427 on the Medicare Telehealth Services List for the duration of
the PHE for Covid-19. A requester stated that data collected during the
PHE demonstrates that the telehealth option is as safe as the in-person
equivalent. We also received a request that we remove this code from
the Medicare Telehealth Services List, citing the importance of in-
person physical examination to ensure quality of care and stating that
a telehealth modality presents patient safety concerns such as those
related to the ability of the practitioner to address side effects of
radiation therapy. Given the safety concerns raised by members of the
practitioner community, we believe this service may not be safely and
effectively furnished, and therefore believe that such concerns merit
removing this item from the telehealth list. We are therefore proposing
to remove this code from the Medicare Telehealth Services List, and we
are
[[Page 61627]]
soliciting comment on these quality of care concerns.
(9) Home International Normalized Ratio (INR) Monitoring
We received a request to permanently add Home INR Monitoring (HCPCS
code G0248) to the Medicare Telehealth Services List. This service is
not on the Medicare Telehealth Services List, nor had it been
previously added and removed. We are proposing to add HCPS code G0248
to the Medicare Telehealth Services List with provision status because
our clinical analyses of these services indicate that they can be
furnished in full using two-way, audio and video technology, and
information provided by requesters indicates that there may be clinical
benefit; however, there is not yet sufficient evidence available to
consider the services for permanent status. This service as described
by the HCPCS code describes face-to-face demonstration of use and care
of the INR monitor, obtaining at least one blood sample, provision of
instructions for reporting home INR test results, and documentation of
patient's ability to perform testing and report results, and we believe
each of these service elements the elements is capable of being
furnished using an interactive telecommunications system. Adding this
service on a provisional basis will allow additional time for the
development of evidence of clinical benefit when this service is
furnished via telehealth for CMS to consider when evaluating this
service for potential permanent addition to the Medicare Telehealth
Services List.
(10) Caregiver Training
We received a request to permanently add Caregiver Training
services, as described by HCPCS codes 97550 (Caregiver training in
strategies and techniques to facilitate the patient's functional
performance in the home or community (eg, 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 CPT code 97551
(Caregiver training in strategies and techniques to facilitate the
patient's functional performance in the home or community (eg,
activities of daily living [ADLs], instrumental ADLs [iADLs],
transfers, mobility, communication, swallowing, feeding, problem
solving, safety practices) (without the patient present), face to face;
each additional 15 minutes (List separately in addition to code for
primary service)) to the Medicare Telehealth Services List. These codes
do not currently appear on the Medicare Telehealth Services List nor
had they previously been added or removed. We are proposing to add
these services to the Medicare Telehealth List with provisional status
for CY 2025, in addition to the other currently payable caregiver
training service codes (CPT codes 97550, 97551, 97552, 96202, 96203).
These codes are new services that were added to the PFS beginning in
2024. Given the limited utilization of those codes added for 2024,
there are not peer-reviewed studies supporting these codes' ability to
be furnished remotely. Adding these services on a provisional basis
will allow additional time for the development of evidence of clinical
benefit when these services are furnished via telehealth for CMS to
consider when evaluating these services for potential permanent
addition to the Medicare Telehealth Services List. Contingent upon
finalizing the service code descriptions that we propose in section
II.E. of this proposed rule, we also propose that HCPCS code GCTD1-3
and GCTB1-2 be added to the Medicare Telehealth Services list for CY
2025 on a provisional basis. We believe that these codes are similar to
other services already available on the Medicare Telehealth Services
List, including education and training for patient self-management (CPT
codes 98960-98962), self-care/home management training (CPT codes
97535), and caregiver-focused health risk assessment (CPT code 96161).
Further, it appears that all elements of these services may be
furnished when using two-way interactive communications technology.
Adding these services on a provisional basis will allow additional time
for the development of evidence of clinical benefit when this service
is furnished via telehealth for CMS to consider when evaluating these
services for potential permanent addition to the Medicare Telehealth
Services List.
c. Other Services Proposed for Addition to the Medicare Telehealth
Services List
(1) Preexposure Prophylaxis (PrEP) of Human Immunodeficiency Virus
(HIV)
As discussed in Section II.E. of this proposed rule, we are
proposing national rates for HCPCS codes G0011 (Individual counseling
for pre-exposure prophylaxis (PrEP) by physician or QHP to prevent
human immunodeficiency virus (HIV), includes: HIV risk assessment
(initial or continued assessment of risk), HIV risk reduction and
medication adherence, 15-30 minutes) and G0013 (Individual counseling
for pre-exposure prophylaxis (PrEP) by clinical staff to prevent human
immunodeficiency virus (HIV), includes: HIV risk assessment (initial or
continued assessment of risk), HIV risk reduction and medication
adherence) pending the future finalization of the NCD for Pre-Exposure
Prophylaxis (PrEP) for Human Immunodeficiency Virus (HIV) Infection. We
believe these services are similar to services currently on the
Medicare Telehealth Services list, specifically HCPCS codes G0445 (High
intensity behavioral counseling to prevent sexually transmitted
infection; face-to-face, individual, includes: education, skills
training and guidance on how to change sexual behavior; performed semi-
annually, 30 minutes) and 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) as these codes are the codes from which HCPCS codes
G0011 and G0013 were unbundled, respectively. As similarity to services
currently on the Medicare telehealth list is one of our criteria for
permanent addition, we are proposing to add HCPCS codes G0011 and G0013
to the Medicare Telehealth Services List with a permanent status.
The services that we are proposing to add to the Medicare
Telehealth Services List are listed in Table 8.
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[GRAPHIC] [TIFF OMITTED] TP31JY24.012
BILLING CODE C
d. 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 frequency restrictions on how
often practitioners may furnish the service via Medicare telehealth.
These include a limitation of one subsequent hospital care service
furnished through telehealth every 3 days, added in the CY 2011 PFS
final rule (75 FR 73317 through 73318), one subsequent nursing facility
visit furnished through telehealth every 14 days, added in the CY 2011
PFS final rule (75 FR73318), and one critical care consultation service
furnished through telehealth per day, added in the CY 2017 final rule
(81 FR 80198). In establishing these limits, we cited concerns
regarding the potential acuity and complexity of these patients.
We temporarily removed these frequency restrictions during the PHE
for COVID-19. In the March 31, 2020 COVID-19 interim final rule with
comment period (IFC) (85 FR 19241), we stated that we did not believe
the frequency limitations for certain subsequent inpatient visits,
subsequent NF visits, and critical care consultations furnished via
Medicare telehealth were appropriate or necessary for the duration of
the PHE because this would have been a patient population who would
have otherwise not had access to clinically appropriate in-person
treatment. Although the frequency limitations resumed effect on May 12,
2023 (upon expiration of the PHE), through enforcement discretion
during the remainder of CY 2023 and notice-and-comment rulemaking for
CY 2024, Medicare telehealth frequency limitations have been suspended
for CY 2024 (88 FR 78876 through 78878) for the following codes
relating to Subsequent Inpatient Visits, Subsequent Nursing Facility
Visits, and Critical Care Consultation Services:
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 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 CY 2025.
In the CY 2024 PFS final rule (88 FR 78877), we solicited comments
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. As discussed in that final rule, many
commenters supported permanently removing these frequency limitations,
stating that they are arbitrary and re-imposing the limitations would
result in decreased access to care; that practitioners should be
allowed to use
[[Page 61632]]
their clinical judgment to determine the type of visit, how many
visits, and the type of treatment that is the best fit for the patient
so long as the standard of care is met; and that lifting these
limitations during the PHE has been instructive and demonstrates the
value of continuing such flexibilities. Many commenters urged us to
permanently remove them. That said, some commenters did not support
removing these frequency limitations citing patient acuity and safety,
some commenters cited the importance of in-person care for patients in
acute care settings. Some commenters stated that telehealth patient
assessments and evaluations are never the same as in-person, hands on
visits and should not be considered a viable replacement with no
limitations for in-person care. We are continuing to consider what
changes we should be making to how telehealth services are reimbursed
under Medicare in light of the way practice patterns may have changed
following the PHE for COVID-19. Taking into account the information
received from commenters in the CY 2024 PFS final rule, we believe it
is reasonable to continue to pause certain pre-pandemic restrictions,
such as the frequency limitations for the abovementioned codes for CY
2025. Removing such restrictions for CY 2025 will allow us to gather an
additional year of data to determine how practice patterns are evolving
and what changes, if any, to frequency limitations should be made. We
do not believe pausing such frequency limitations for another year
presents a level of safety risk requiring us to immediately reinstate
the limitations. Our analysis of claims data indicates that the volume
of services that would be affected by implementing these limitations is
relatively low; in other words, these services are not being furnished
via telehealth with such frequency that frequency limits are being met
or exceeded very often or for many beneficiaries (claims data from
2020--2023 suggest that less than five percent received one or more of
these services as a telehealth service). Therefore, while claims data
does not suggest that lifting these limitations during the PHE has led
to an increase in utilization, we continue to be interested in
information from interested parties on our concerns regarding the
potential acuity and complexity of these patients and how such acuity
and complexity should complexity should influence our implementation of
frequency limitations.
e. Audio-Only Communication Technology To Meet the Definition of
``Telecommunications System''
Through our regulation at Sec. 410.78(a)(3), we define
``interactive telecommunications system'' as multimedia communications
equipment that includes, at a minimum, audio and video equipment
permitting two-way, real-time interactive communication between the
patient and distant site physician or practitioner. Through emergency
regulations and waiver authority under section 1135(b)(8) of the Act,
in response to the PHE for COVID-19, we allowed the use of audio-only
communications technology to furnish services described by the codes
for audio-only telephone evaluation and management services and
behavioral health counseling and educational services. Section 4113 of
the CAA, 2023, extended the availability of telehealth services that
can be furnished using audio-only technology and provided for the
extension of other PHE-related flexibilities including removal of the
geographic and location limitations under section 1834(m) of the Act
through December 31, 2024.
In the CY 2022 PFS final rule (86 FR 65060), in part to recognize
the changes made by section 123 of the CAA, 2021 that removed the
geographic restrictions for Medicare telehealth services for the
diagnosis, evaluation, or treatment of a mental health disorder and the
addition of the patient's home as a permissible originating site for
these services, we revisited our regulatory definition of ``interactive
telecommunications system'' beyond the circumstances of the PHE.
Specifically, we finalized a policy to allow for audio-only services
under certain circumstances and revised the regulation at Sec.
410.78(a)(3) to permit the use of audio-only equipment for telehealth
services furnished to established patients in their homes for purposes
of diagnosis, evaluation, or treatment of a mental health disorder
(including substance use disorders) if the distant site physician or
practitioner is technically capable of using an interactive
telecommunications system as defined previously, but the patient is not
capable of, or does not consent to, the use of video technology. We
also established this policy in part because mental health services are
different from most other services on the Medicare telehealth services
list in that many of the services primarily involve verbal conversation
where visualization between the patient and furnishing physician or
practitioner may be less critical to the provision of the service.
However, with the successive statutory extensions of the telehealth
flexibilities implemented in response to the PHE for COVID-19, most
recently by the CAA, 2023, and our adoption of other extensions where
we have had authority to do so, we have come to believe that it would
be appropriate to allow interactive audio-only telecommunications
technology when any telehealth service is furnished to a beneficiary in
their home (when the patient's home is a permissible originating site)
and when the distant site physician or practitioner is technically
capable of using an interactive telecommunications system as defined
previously, but the patient is not capable of, or does not consent to,
the use of video technology. While practitioners should always use
their clinical judgment as to whether the use of interactive audio-only
technology is sufficient to furnish a Medicare telehealth service, we
recognize that there is variable broadband access in patients' homes,
and that even when technologically feasible, patients simply may not
always wish to engage with their practitioner in their home using
interactive audio and video. Under current statute, with the expiration
of the PHE-related telehealth flexibilities on December 31, 2024, the
patient's home is a permissible originating site only for services for
the diagnosis, evaluation, or treatment of a mental health or substance
use disorder, and for the monthly ESRD-related clinical assessments
described in section 1881(b)(3)(B) of the Act.
We are proposing to revise the regulation at Sec. 410.78(a)(3) to
state that an interactive telecommunications system may also include
two-way, real-time audio-only communication technology for any
telehealth service furnished to a beneficiary in their home if the
distant site physician or practitioner is technically capable of using
an interactive telecommunications system as defined as multimedia
communications equipment that includes, at a minimum, audio and video
equipment permitting two-way, real-time interactive communication, but
the patient is not capable of, or does not consent to, the use of video
technology. Additionally, a modifier designated by CMS must be appended
to the claim for services described in this paragraph to verify that
these conditions have been met. These are CPT modifier ``93'' and, for
RHCs and FQHCs, Medicare modifier ``FQ'' (Medicare telehealth service
was furnished using audio-only communication technology).
[[Page 61633]]
Practitioners have the option to use the ``FQ'' or the ``93'' modifiers
or both where appropriate and true, since they are identical in
meaning.
f. Distant Site Requirements
In the CY 2024 PFS final rule (88 FR 78873 through 78874) we
discussed that many commenters expressed concerns regarding the
expiring flexibility for telehealth practitioners to bill from their
currently enrolled location instead of their home address when
providing telehealth services from their home. CMS issued an FAQ,
available at https://www.cms.gov/files/document/physicians-and-other-clinicians-cms-flexibilities-fight-covid-19.pdf, which extended the
flexibility for telehealth practitioners to bill from their currently
enrolled location instead of their home address when providing
telehealth services from their home through December 31, 2023.
Interested parties suggested that the expiration of this flexibility
poses a potential and imminent threat to the safety and privacy of
health professionals who work from home and furnish telehealth
services. Commenters cited recent examples of workplace violence in
health care facilities, where direct harm to nurses and other medical
staff occurred. In addition to safety and privacy concerns, interested
parties explained that a significant number of practitioners would need
to change their billing practices or add their home address to the
Medicare enrollment file, coordinating with the appropriate Medicare
Administrative Contractor in their jurisdiction, and this would present
administrative burden. To address these concerns, commenters requested
that CMS take steps to protect telehealth practitioners by adjusting
enrollment requirements so that individual practitioners do not have to
list their home addresses on enrollment forms.
In response, CMS finalized, through CY 2024, that we would continue
to permit a distant site practitioner to use their currently enrolled
practice location instead of their home address when providing
telehealth services from their home.
We have continued to hear from interested parties who have stressed
the importance of continuing this flexibility for the safety and
privacy of health care professionals. Given the shift in practice
patterns toward models of care that include the practitioner's home as
the distant site, we believe it would be appropriate to continue this
flexibility as CMS considers various proposals that may better protect
the safety and privacy of practitioners. We are therefore proposing
that through CY 2025 we will continue to permit the distant site
practitioner to use their currently enrolled practice location instead
of their home address when providing telehealth services from their
home.
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 described under Sec. 410.32 and services incident to
a physician's (or other practitioner's) professional service described
under Sec. 410.26 (incident-to services), are required to be furnished
under specific minimum levels of supervision by a physician or other
practitioner. We define three levels of supervision in our regulation
at Sec. 410.32(b)(3): General Supervision, Direct Supervision, and
Personal Supervision. Notwithstanding the temporary measures
implemented in response to the PHE for COVID-19, direct supervision
requires the physician (or other supervising practitioner) to be
present in the office suite and immediately available to furnish
assistance and direction throughout the performance of the service. It
does not mean that the physician (or other supervising practitioner)
must be present in the room when the service is performed. Again,
notwithstanding the temporary measures implemented in response to the
PHE for COVID-19, 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)).
Direct supervision is required for various types of services,
including most incident-to services under Sec. 410.26, many diagnostic
tests under Sec. 410.32, pulmonary rehabilitation services under Sec.
410.47, cardiac rehabilitation and intensive cardiac rehabilitation
services under Sec. 410.49, and certain hospital outpatient services
as provided under Sec. 410.27(a)(1)(iv). In the March 31, 2020 COVID-
19 IFC, we amended the definition of ``direct supervision'' for the
duration of the PHE for COVID-19 (85 FR 19245 through 19246) at Sec.
410.32(b)(3)(ii) to state that the necessary presence of the physician
(or other practitioner) for direct supervision includes virtual
presence through audio/video real-time communications technology.
Instead of requiring the supervising physician's (or other
practitioner's) physical presence, the amendment permitted a
supervising physician (or other practitioner) to be considered
``immediately available'' through virtual presence using two-way, real-
time audio/visual technology for diagnostic tests, incident-to
services, pulmonary rehabilitation services, and cardiac and intensive
cardiac rehabilitation services. We made similar amendments at Sec.
[thinsp]410.27(a)(1)(iv) to specify that direct supervision for certain
hospital outpatient services may include virtual presence through
audio/video real-time communications. The CY 2021 PFS final rule (85 FR
84538 through 84540) and the CY 2024 PFS final rule (88 FR 78878)
subsequently extended these policies through December 31, 2024. As
stated in the CY 2024 PFS final rule, we extended this definition of
direct supervision through December 31, 2024, in order to align the
timeframe of the policy with other PHE-related telehealth policies that
were extended most recently under the provisions of the CAA, 2023.
We note that in the CY 2021 PFS final rule (85 FR 84539) we
clarified 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 service. We
noted that this was the case during the PHE and would continue to be
the case following the PHE. While flexibility to provide direct
supervision through audio/video real-time communications technology was
adopted to be responsive to critical needs during the PHE for COVID-19
to ensure beneficiary access to care, reduce exposure risk and to
increase the capacity of practitioners and physicians to respond to
COVID-19, we expressed concern that direct supervision through virtual
presence may not be sufficient to support PFS payment on a permanent
basis, beyond the PHE for COVID-19, due to issues of patient safety.
For instance, in complex, high-risk, surgical, interventional, or
endoscopic procedures, or anesthesia procedures, a patient's clinical
status can quickly change; in-person supervision would be necessary for
such services to allow for rapid on-site decision-making in the event
of an
[[Page 61634]]
adverse clinical situation. In addition to soliciting comment in the CY
2021 PFS proposed rule on whether there should be any additional
``guardrails'' or limitations to ensure patient safety/clinical
appropriateness, beyond typical clinical standards, as well as
restrictions to prevent fraud or inappropriate use, we solicited
comment in the CY 2024 PFS proposed rule on whether we should consider
extending the definition of direct supervision to permit virtual
presence beyond December 31, 2024. Specifically, we stated that we were
interested in input from interested parties on potential patient safety
or quality concerns when direct supervision occurs virtually; for
instance, if direct supervision of certain types of services with
virtual presence of the supervising practitioner 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 were
also interested in potential program integrity concerns that interested
parties may have regarding this policy, such as overutilization or
fraud and abuse.
(1) Proposal To Extend Definition of ``Direct Supervision'' To Include
Audio-Video Communications Technology Through 2025
As discussed in the CY 2024 PFS final rule (88 FR 78878), in the
absence of evidence that patient safety is compromised by virtual
direct supervision, we are concerned about an abrupt transition to our
pre-PHE policy that defines direct supervision to require the physical
presence of the supervising practitioner. We noted 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 incident-to services, and that
physicians and/or other supervising practitioners, in certain
instances, would 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. We
acknowledge the utilization of this flexibility and recognize that many
practitioners have stressed the importance of maintaining it, however
we seek additional information regarding potential patient safety and
quality of care concerns. This flexibility has been available and
widely utilized since the beginning of the PHE, and we recognize that
may enhance patient access. However, given the importance of certain
services being furnished under direct supervision in ensuring quality
of care and patient safety, and in particular the ability of the
supervising practitioner to intervene if complications arise, we
believe an incremental approach is warranted, particularly in instances
where unexpected or adverse events may arise for procedures which may
be riskier or more intense. In light of these potential safety and
quality of care implications, and exercising an abundance of caution,
we are extending this flexibility for all services on a temporary basis
only. We are therefore proposing to 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, 2025.
(2) Proposal To Permanently Define ``Direct Supervision'' To Include
Audio-Video Communications Technology for a Subset of Services
In the CY 2024 PFS proposed rule, we solicited comment on extending
or permanently establishing the virtual presence flexibility for
certain services valued under the PFS given that these services
typically are performed in their entirety by auxiliary personnel as
defined at Sec. 410.26(a)(1). We stated such services would include
incident-to services wholly furnished by auxiliary personnel, Level I
office or other outpatient E/M visits for established patients. We also
mentioned Level I Emergency Department (ED) visits in this list, but
have since concluded that ED services would not be wholly furnished by
auxiliary personnel and, for that reason, have excluded them from the
discussion in this proposed rule. Based on our review, these specific
services present less of a patient safety concern than services for
which there may be a need for immediate intervention of the supervising
practitioner; as noted in the CY 2024 PFS proposed rule, allowing
virtual presence for direct supervision of these services could 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. After
reviewing the various comments in response to this solicitation,
additional feedback provided by interested parties, and conducting our
own independent review, we believe these services are low risk by their
nature, do not often demand in-person supervision, are typically
furnished entirely by the supervised personnel, and allowing virtual
presence for direct supervision of these services would balance patient
safety concerns with the interest of supporting access and preserving
workforce capacity.
We are proposing to adopt a definition of direct supervision that
allows ``immediate availability'' of the supervising practitioner using
audio/video real-time communications technology (excluding audio-only),
but only for the following subset of incident-to services described
under Sec. 410.26: (1) services furnished incident to a physician or
other practitioner's service when provided by auxiliary personnel
employed by the billing practitioner and working under their direct
supervision, and for which the underlying HCPCS code has been assigned
a PC/TC indicator of `5'; \10\ and (2) services described 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). As
provided in the code descriptor for CPT code 99211, an office or other
outpatient visit for the evaluation and management of an established
patient may not require the presence of a physician or other
practitioner and may be furnished incident to a physicians' service by
a nonphysician employee of the physician under direct supervision. The
service described by CPT code 99211 and the services that are
identified with a PC/TC indicator of `5' as listed in the PFS Relative
Value Files are services that are nearly always performed in entirety
by auxiliary personnel. The vignette for CPT code 99211 describes the
provision of supervision and guidance to the clinical staff as
necessary. The code descriptor for this service specifies an E/M
service that may not require the presence of a physician or other
professional; and the current valuation, which is relatively low
compared to other office and outpatient E/M services, suggests that
this service would primarily be provided by auxiliary personnel.
---------------------------------------------------------------------------
\10\ For a full list of all PFS payment status indicators and
descriptions, see the Medicare Claims Processing Manual (IOM Pub.
100-04, chapter 23, sections 30.2.2). For a full list of all PFS
payment status indicators and descriptions, see the Medicare Claims
Processing Manual (IOM Pub. 100-04, chapter 23, sections 30.2.2 and
50.6). Specific indicators by service are listed in the PFS Relative
Value files at https://www.cms.gov/medicare/payment/fee-schedules/physician/pfs-relative-value-files).
---------------------------------------------------------------------------
We are proposing an incremental approach whereby we will adopt
without any time limitation the definition of direct supervision
[[Page 61635]]
permitting virtual presence for services that are inherently lower
risk: that is, services that do not ordinarily require the presence of
the billing practitioner, do not require direction by the supervising
practitioner to the same degree as other services furnished under
direct supervision, and are not services typically performed directly
by the supervising practitioner.
For all other services required to be furnished under the direct
supervision of the supervising physician or other practitioner, we are
proposing, as described above, to continue to define ``immediate
availability'' to include real-time audio and visual interactive
telecommunications technology only through December 31, 2025.
We are proposing to revise the regulations at Sec.
410.32(b)(3)(ii) to state that through December 31, 2025, the presence
of the physician (or other practitioner) would include virtual presence
through audio/video real-time communications technology (excluding
audio-only).
We are proposing to revise the regulation at Sec. 410.26(a)(2) to
state that for the following services furnished after December 31,
2025, the presence of the physician (or other practitioner) required
for direct supervision shall continue to include virtual presence
through audio/video real-time communications technology (excluding
audio-only): services furnished incident to a physician's service when
they are provided by auxiliary personnel employed by the physician and
working under his or her direct supervision and for which the
underlying HCPCS code has been assigned a PC/TC indicator of `5'; and
office and other outpatient visits for the evaluation and management of
an established patient that may not require the presence of a physician
or other qualified health care professional.
(3) Teaching Physician Billing for Services Involving Residents With
Virtual Presence
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
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 in increasing beneficiary
access to Medicare-covered services in rural areas. We 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,
under 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. We refer readers to the CY 2021 PFS final rule
(85 FR 84577 through 84584) for a more detailed description of our
specific concerns. 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 applied
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 expressed concerns regarding the requirement that the teaching
physician be physically present with the resident when a service is
furnished virtually (as a Medicare telehealth service) within an MSA.
Some interested parties 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 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. After review of the public comments, we finalized a policy that
allowed the teaching physician to have a virtual presence in all
teaching settings, only in clinical instances when the service was
furnished virtually (for example, a 3-way telehealth visit, with all
parties in separate locations). This permitted teaching physicians to
have a virtual presence during the key portion of the Medicare
telehealth service for which payment was sought, through audio/video
real-time communications technology, in all residency training
locations through December 31, 2024.
As stated in the CY 2024 PFS final rule (88 FR 78880), we are
concerned that an abrupt transition to our pre-PHE policy may present a
barrier to access to many services. We also understand that teaching
physicians have gained clinical experience providing services involving
residents with virtual presence during the PHE for COVID-19 and could
help us to identify circumstances where the teaching physician can
routinely provide sufficient personal and identifiable services to the
patient through their virtual presence during the key portion of the
Medicare telehealth service. We sought comment and information to help
us consider other clinical treatment situations where it may be
appropriate to continue to permit the virtual presence of the teaching
physician, while continuing to support patient safety, meeting the
clinical needs for all patients, and ensuring burden reduction without
creating risks to patient care or increasing opportunities for fraud.
As summarized in the CY 2024 PFS final rule (88 FR 78881 through
78882), commenters encouraged us to establish this policy permanently
and include in-person services to promote access to care, stated that
teaching physicians should be allowed to determine when their virtual
presence would be clinically appropriate, based on their assessment of
the patient's needs and the competency level of the resident. While we
continue to consider clinical scenarios where it may be appropriate to
permit the virtual presence of the teaching physician, we are proposing
to continue our current policy to allow teaching physicians to have a
virtual presence for purposes of billing for services furnished
involving residents in all teaching settings, but only when the service
is furnished virtually (for example, a 3-way telehealth visit, with the
patient, resident, and teaching physician 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 in any residency training location through December 31, 2025.
The teaching physician's virtual presence would continue to require
real-time observation (not mere availability) and
[[Page 61636]]
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 Medicare telehealth
service, which includes documenting the specific portion of the service
for which the teaching physician was present through audio/video real-
time communications technology.
(a) Request for Information for Teaching Physician Services Furnished
Under the Primary Care Exception
The so-called primary care exception set forth at Sec. 415.174
permits the teaching physician to bill for certain lower and mid-level
complexity physicians' services furnished by residents in certain types
of residency training settings even when the teaching physician is not
present with the resident during the services as long as certain
conditions are met, including that the services are furnished by
residents with more than 6 months of training in the approved residency
program; and that the teaching physician directs the care of no more
than four residents at a time, remains immediately available and has no
other responsibilities while directing the care, assumes management
responsibility for beneficiaries seen by the residents, ensures that
the services furnished are appropriate, and reviews certain elements of
the services with each resident during or immediately after each visit.
For a more detailed description of the list of services currently
allowed under the primary care exception policy, we refer readers to
the CY 2021 PFS final rule (85 FR 84585 through 84590).
We have received feedback from interested parties requesting that
we permanently expand the list of services that can be furnished under
the primary care exception to include all levels of E/M services and
additional preventive services. These interested parties have stated
that the fact that high-value primary care and preventive services are
not included in the scope of the primary care exception discourages
their integration in residency training in these primary care settings,
which has a negative impact on physician training, patient access, and
longer-term outcomes. Additionally, these interested parties have
suggested that including all levels of E/M services under the primary
care exception could support primary care workforce development and
improve patient continuity of care without compromising patient safety;
furthermore, including additional preventive services within the
primary care exception would increase the utilization of high-value
services.
We believe the primary care exception was intended to broaden
opportunities for teaching physicians to involve residents in
furnishing services under circumstances that preserve the direction of
the care by the teaching physician and promote safe, high-quality
patient care. As such, we are requesting information to help us
consider whether and how best to expand the array of services included
under the primary care exception in future rulemaking. We are
interested in hearing more about the types of services that could be
allowed under the primary care exception, specifically preventive
services, and whether the currently required six months of training in
an approved program is sufficient for residents to furnish these types
of services without the presence of a teaching physician. We are
seeking comment to help us consider whether adding certain preventive
services or higher level E/M services to the primary care exception
would hinder the teaching physician from maintaining sufficient
personal involvement in the care to warrant PFS payment for the
services being furnished by up to four residents at any given time.
Similarly, we are requesting information on whether the inclusion in
the primary care exception of specific higher-level or preventive
services would impede the teaching physician's ability to remain
immediately available for up to four residents at any given time, while
directing and managing the care furnished by these residents.
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 2025 is 3.6 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 2025
based on historical data through the second quarter of 2024. Therefore,
for CY 2025, the proposed payment amount for HCPCS code Q3014
(Telehealth originating site facility fee) is $31.04. Table 9 shows the
Medicare telehealth originating site facility fee and the corresponding
MEI percentage increase for each applicable time period.
BILLING CODE P
[[Page 61637]]
[GRAPHIC] [TIFF OMITTED] TP31JY24.013
BILLING CODE C
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
For information related to outpatient physical therapy,
occupational therapy, speech-language pathology, diabetes self-
management training (DSMT) and medical nutritional therapy (MNT)
services furnished by institutional staff in hospitals and other
institutional settings to beneficiaries in their homes through
communication technology, please refer to section X.A. in the CY 2025
Hospital Outpatient Prospective Payment System (OPPS) proposed rule (FR
Doc. 2024-15087), on public inspection July 10, 2024, and publishing in
the Federal Register of July 22, 2024.
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 outlined 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
[[Page 61638]]
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 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 discuss our approach to reviewing RUC
recommendations and developing
[[Page 61639]]
proposed values for specific codes. When they exist, we also include a
summary of interested party reactions to our approach. We noted 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
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 suggested that
our actions in adjusting the recommended work RVUs are 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 we are proposing work RVUs for CY 2025; this
includes all codes for which we received RUC recommendations by
February 10, 2024. The proposed work RVUs, work time and other payment
information for all CY 2025 payable codes are available on the CMS
website under downloads for the CY 2025 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
[[Page 61640]]
comparative databases, as well as a comparison with other codes within
the PFS, and consultation with physicians and health care professionals
within CMS and the Federal Government, as well as Medicare claims data.
We also assess the methodology and data used to develop the
recommendations submitted to us by the RUC and other public commenters
and the rationale for the recommendations. When we determine that the
RUC's recommendations appropriately estimate the direct PE inputs
(clinical labor, disposable supplies, and medical equipment) required
for the typical service, are consistent with the principles of
relativity, and reflect our payment policies, we use those direct PE
inputs to value a service. If not, we refine the recommended PE inputs
to better reflect our estimate of the PE resources required for the
service. We also confirm whether CPT codes should have facility and/or
nonfacility direct PE inputs and refine the inputs accordingly.
Our review and refinement of the RUC-recommended direct PE inputs
includes many refinements that are common across codes, as well as
refinements that are specific to particular services. Table 14 details
our refinements of the RUC's direct PE recommendations at the code-
specific level. In section II.B. of this proposed rule, Determination
of 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. In this proposed rule, we also note that many of the
refinements listed in Table 14 result in changes under the $0.35
threshold and would be unlikely to result in a change to the RVUs.
We note that the direct PE inputs for CY 2025 are displayed in the
CY 2025 direct PE input files, available on the CMS website under the
downloads for the CY 2025 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 2025 PE RVUs as displayed in Addendum B (see
https://www.cms.gov/medicare/payment/prospective-payment-systems/hospital-outpatient/addendum-a-b-updates).
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 referred 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
[[Page 61641]]
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 2025 we received invoices for several new supply and
equipment items. Tables 17 and 18 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 17 and 18 also include the number of
invoices received and the number of nonfacility allowed services for
procedures that use these equipment items. We provide the nonfacility
allowed services so that interested parties will note the impact the
particular price might have on PE relativity, as well as to identify
items that are used frequently, since we believe that interested
parties are more likely to have better pricing information for items
used more frequently. A single invoice may not be reflective of typical
costs, and we encourage interested parties to provide additional
invoices so that we might identify and use accurate prices in the
development of PE RVUs.
In some cases, we do not use the price listed on the invoice that
accompanies the recommendation because we identify publicly available
alternative prices or information that suggests a different price is
more accurate. In these cases, we include this in the discussion of
these codes. In other cases, we cannot adequately price a newly
recommended item due to inadequate information. Sometimes, no
supporting information regarding the price of the item has been
included in the recommendation. In other cases, the supporting
information does not demonstrate that the item has been purchased at
the listed price (for example, vendor price quotes instead of paid
invoices). In cases where the information provided on the item allows
us to identify clinically appropriate 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
2025 are available on the CMS website under downloads for the CY 2025
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 section 1833(t)(2)(D), 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 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 2025, we identified new and revised codes to determine which
services meet the definition of ``imaging services'' as defined at
section 1848(b)(4)(B) of the Act for purposes of this cap. Beginning
for CY 2025, we are proposing to include the following services on the
list of codes to which the OPPS cap applies: CPT codes 0868T (High-
resolution gastric electrophysiology mapping with simultaneous patient-
symptom profiling, with interpretation and
[[Page 61642]]
report), 0876T (Duplex scan of hemodialysis fistula, computer-aided,
limited (volume flow, diameter, and depth, including only body of
fistula)), 74263 (Computed tomographic (ct) colonography, screening,
including image postprocessing), 9X059 (Computerized ophthalmic
diagnostic imaging (eg, optical coherence tomography [OCT]), posterior
segment, with interpretation and report, unilateral or bilateral;
retina including OCT angiography), 93X94 (Vasoreactivity study
performed with transcranial Doppler study of intracranial arteries,
complete (List separately in addition to code for primary procedure)),
93X95 (Emboli detection without intravenous microbubble injection
performed with transcranial Doppler study of intracranial arteries,
complete (List separately in addition to code for primary procedure)),
and 93X96 (Venous-arterial shunt detection with intravenous microbubble
injection performed with transcranial Doppler study of intracranial
arteries, complete (List separately in addition 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.
In the CY 2024 PFS final rule (88 FR 78894), we noted that in
response to the CY 2024 PFS proposed rule, commenters requested that
CMS remove CPT code 92229 (Imaging of retina for detection or
monitoring of disease; point-of-care autonomous analysis and report,
unilateral or bilateral) from the OPPS cap list because it does not
include an associated PC or physician interpretation and it is
primarily utilized in the physician office setting. We are soliciting
comment on the appropriateness of applying the OPPS cap to services
such as this for which the interpretation component is not captured by
work RVUs, and the service is not split into technical and professional
components. We are more broadly evaluating how services involving
assistive technologies are most accurately valued. We note that the
OPPS rate for this service is currently higher than what would be paid
in a physician office setting, and therefore the OPPS cap does not
currently apply to CPT code 92229 as of 2024.
4. Valuation of Specific Codes for CY 2025
(1) Skin Cell Suspension Autograft (CPT codes 15XX1, 15XX2, 15XX3,
15XX4, 15XX5, 15XX6, 15XX7, and 15XX8)
In September 2023, the CPT Editorial Panel approved the creation of
eight new CPT codes to describe skin cell suspension autograft (SCSA)
procedures. The code set includes a 000-day global base code (CPT code
15XX1 (Harvest of skin for skin cell suspension autograft; first 25 sq
cm or less)) and an add-on code (CPT code 15XX2 (Harvest of skin for
skin cell suspension autograft; each additional 25 sq cm or part
thereof (List separately in addition to code for primary procedure)))
describing the harvesting component of the procedure, an XXX global
base code (CPT code 15XX3 (Preparation of skin cell suspension
autograft, requiring enzymatic processing, manual mechanical
disaggregation of skin cells, and filtration; first 25 sq cm or less of
harvested skin) and an add-on code (CPT code 15XX4 (Preparation of skin
cell suspension autograft, requiring enzymatic processing, manual
mechanical disaggregation of skin cells, and filtration; each
additional 25 sq cm of harvested skin or part thereof (List separately
in addition to code for primary procedure))) describing the preparation
component of the procedure, and two 090-day global base codes and two
add-on codes for the application component to distinguish between body
areas: trunk, arms, and legs with CPT codes 15XX5 (Application of skin
cell suspension autograft to wound and donor sites, including
application of primary dressing, trunk, arms, legs; first 480 sq cm or
less) and 15XX6 (Application of skin cell suspension autograft to wound
and donor sites, including application of primary dressing, trunk,
arms, legs; each additional 480 sq cm or part thereof (List separately
in addition to code for primary procedure)); and face, scalp, eyelids,
mouth, neck, ears, orbits, genitalia, hands, feet, or multiple digits
with CPT codes 15XX7 (Application of skin cell suspension autograft to
wound and donor sites, including application of primary dressing, face,
scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/
or multiple digits; first 480 sq cm or less) and 15XX8 (Application of
skin cell suspension autograft to wound and donor sites, including
application of primary dressing, face, scalp, eyelids, mouth, neck,
ears, orbits, genitalia, hands, feet, and/or multiple digits; each
additional 480 sq cm or part thereof (List separately in addition to
code for primary procedure)).
We disagree with the RUC-recommended work RVUs of 3.00, 2.00, 2.51,
2.00, 10.97, 2.50, 12.50, and 3.00 for CPT codes 15XX1 through 15XX8,
respectively, and are proposing contractor-pricing for these CPT codes
due to concerns with the coding structure of the code family and the
total physician time that results when these codes are billed multiple
times on the same date of service for the typical patient.
We note that our concerns with these CPT codes are expansive.
Firstly, we note that these CPT codes represent a segmentation of a
single service that is performed sequentially on the same date of
service. We are seeking comment on whether the segmentation of the
harvest, preparation, and application is necessary when these are
sequential service parts of one episode of care, and could be
simplified by having just two codes that encompass all three service
parts (harvest, preparation, and application), to differentiate the two
different application areas. We also are soliciting comment on the base
and add-on codes' incremental square centimeters, considering that the
typical size treatment area described in the vignettes could result in
the add-on codes being billed multiple times, particularly for the base
application CPT code 15XX5 and add-on CPT code 15XX6. Based on the
meeting notes from the September 2023 CPT Editorial Panel meeting, the
specialty society initially structured their coding request to
``bundle'' the service components into fewer codes, but it is unclear
to us why these codes were further segmented. We believe that the very
large range of intraservice times from the 33 burn surgeons may have
been exacerbated by the harvest, preparation, and application
components of the service being segmented in this manner. Most notably,
CPT code 15XX1, which describes the first 25 sq cm of harvest, base
code, had an intraservice survey time range of 5 to 480 minutes, and
CPT code 15XX7, which describes the first 480 sq cm of application to
the face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands,
feet, and/or multiple digits, had an intraservice survey time range of
10 to 360 minutes.
We note that the survey median intraservice times for CPT codes
15XX1 through 15XX8 contradict numerous publicly available sources that
describe much lower times for this service or specific service parts.
Most notably, the manufacturer of the RECELL Autologous Cell Harvesting
Device (RECELL[supreg] System) used in this service, indicates
[[Page 61643]]
that a suspension of Spray-On SkinTM Cells using a small
sample of the patient's own skin for the treatment of thermal burn
wounds and full-thickness skin defects is ``prepared and applied at the
point of care in as little as 30 minutes.'' \11\ Additionally, Temple
University Hospital published a news article on December 20, 2019, just
11 months after the U.S. Food and Drug Administration (FDA) approval of
the RECELL[supreg] System for the treatment of acute thermal second and
third-degree burns in adult patients in January 2019, stating that the
entire process of skin sample collection, enzyme solution preparation,
and suspension spraying/application ``can take as little as 30
minutes'' and ``treat a wound up to 80 times the size of the donor skin
sample.'' \12\ Additionally, an article published in Europe PubMed
Central states that the procedure takes approximately 30 minutes and is
performed by a burn surgeon trained in how to use RECELL[supreg]
System, and does not require specialized laboratory staff.\13\
Additionally, a 2007 study aimed at comparing the results from the
RECELL[supreg] System and the classic skin grafting for epidermal
replacement in deep partial thickness burns showed a total procedure
time of 594 minutes for the RECELL[supreg] System
group.\14\
---------------------------------------------------------------------------
\11\ https://avitamedical.com/.
\12\ Temple Burn Center Using Spray-On SkinTM Cells Technology
to Offer Patients a New, Less Invasive Option for the Treatment of
Severe Burns. (2019, December 20). https://medicine.temple.edu/news/temple-burn-center-using-spray-skin-cells-technology-offer-patients-new-less-invasive-option.
\13\ Cooper-Jones B, Visintini S. A Noncultured Autologous Skin
Cell Spray Graft for the Treatment of Burns. In: CADTH Issues in
Emerging Health Technologies. Canadian Agency for Drugs and
Technologies in Health, Ottawa (ON); 2016. PMID: 30855772.
\14\ G. Gravante, M.C. Di Fede, A. Araco, M. Grimaldi, B. De
Angelis, A. Arpino, V. Cervelli, A. Montone, A randomized trial
comparing ReCell[supreg] system of epidermal cells delivery versus
classic skin grafts for the treatment of deep partial thickness
burns, Burns, Volume 33, Issue 8, 2007, Pages 966-972, ISSN 0305-
4179, https://doi.org/10.1016/j.burns.2007.04.011.
---------------------------------------------------------------------------
More granularly, the FDA's Instructions for Use of the
RECELL[supreg] Autologous Cell Harvesting Device state that ``if a skin
sample is harvested and processed according to these instructions, it
should require between 15 and 30 minutes of contact with the
Enzyme''.\15\ Additionally, the National Institute for Health and Care
Excellence (NICE) produced guidance on using the RECELL[supreg] System
based on the consideration of evidence submitted and the views of
expert advisers, and stated that the harvested skin is added to the
proprietary enzyme solution in a processing unit and heated for 15 to
30 minutes to disaggregate the cells. The skin is then removed and
scraped with a scalpel to develop a plume of cells. These cells are
added to a buffer solution, aspirated and filtered to create a cell
suspension that contains keratinocytes, melanocytes, fibroblasts and
Langerhans cells.\16\ This correlates to the preparation component of
the service described by CPT codes 15XX3 and 15XX4, for which the RUC
recommended the survey median time of 33 and 28 minutes, respectively.
---------------------------------------------------------------------------
\15\ https://www.fda.gov/media/169630/download.
\16\ National Institute for Health and Care Excellence. The
ReCell Spray-On Skin system for treating skin loss, scarring and
depigmentation after burn injury. Medical technologies guidance
[MTG21] [internet]. 2014. [Accessed 16 Nov 2017]. https://www.nice.org.uk/guidance/mtg21/documents/the-recell-sprayon-skin-system-for-treating-skin-loss-scarring-and-depigmentation-after-burn-injury-medical-technology-consultation-document.
---------------------------------------------------------------------------
We believe that the publicly available sources that make
representations about the total service and preparation times
contradict the RUC-recommended median times based on the survey of 33
burn surgeons. Moreover, when we considered how the add-on CPT codes
15XX2, 15XX4, 15XX6, and 15XX8 would be billed based on the typical
patient described in the vignettes, we believe the survey times are
inflated compared to the publicly available sources, likely due to how
the survey respondents considered the service given the segmentation of
the code set. For example, the vignette for CPT code 15XX5 describing
the application to the trunk, arms, and legs says ``A 35-year-old male
sustained partial-thickness thermal burns on his trunk and arms
measuring 3,600 sq cm. A skin cell suspension autograft is applied to
480 sq cm of the wound bed.'' Of the 33 burn surgeons surveyed, 96
percent found this vignette to be typical. Given the typical sq cm
application area of 3,600 sq cm and the expansion ratio of harvested
and prepared skin to treatment skin for application of 1:80, the
typical episode of care would constitute 1 unit of both CPT codes 15XX1
and 15XX2 for harvesting, 1 unit of both CPT codes 15XX3 and 15XX4 for
preparation, 1 unit of CPT code 15XX5 for the first 480 sq cm of
application, and 7 units of CPT code 15XX6 for the remaining 3,120 sq
cm of application area. When the RUC-recommended intraservice and total
times (not including the post-operative visit time for CPT code 15XX5)
for all the units billed on the same date of service as sequential
service parts are summed, the intraservice time totals to 399 minutes
and total time (not including the post-operative visit time included in
the global period for CPT code 15XX5) totals to 529 minutes. The
intraservice time total alone is nearly 6 and 2/3 hours.
We note the RUC recommended that CPT codes 15XX1 through 15XX8 be
placed on the New Technology list to be re-reviewed by the RUC for both
work and PE for the September 2026 or January 2027 RUC meeting when
2025 Medicare utilization data is available, and at that time, the RUC
would consider if other specialties were performing the service and if
the service was performed in the non-facility setting. We look forward
to re-reviewing these CPT codes when recommendations are re-submitted
with more robust and inclusive survey data. In the meantime, we
encourage the reconsideration of the family's coding structure by the
CPT Editorial Panel given the challenging aspects of this service,
including the fact that the current coding structure represents a
severely segmented single episode of care with troublesome billing
patterns for the typical patient, particularly for the add-on CPT code
15XX6 describing the additional 480 sq cm increments of application on
the trunk, arms, and legs. This code is particularly concerning because
the coding structure of the family requires 7 units of add-on CPT code
15XX6 to be billed for the typical patient. Similarly, the typical
patient described in the vignettes for this family of codes would
require 3 units of add-on CPT code 15XX8 due to the coding structure.
We are also seeking feedback on the recommended global period for
CPT code 15XX3. The RUC recommended an XXX global period, which
indicates that the global concept does not apply, but we believe a 000-
day global period, indicating an endoscopic or minor procedure with
related preoperative and postoperative relative values on the day of
the procedure only in the fee schedule payment amount, may be more
appropriate given the nature of the service (which is intertwined with
the other codes in the series) and that the entire service cannot be
completed without 15XX3. This would allow the entire service to run
within a surgical global period.
We note that we believe contractor-pricing is appropriate for CPT
codes 15XX1 through 15XX8 until reconsideration of the coding structure
and re-survey is complete, given the concerning aspects of the CPT
codes. We note that this service is currently billed for using
contractor-priced CPT code 17999 (Unlisted procedure, skin, mucous
membrane and subcutaneous
[[Page 61644]]
tissue) and the eight new codes are expected to be a very low
utilization.
(2) Hand, Wrist, & Forearm Repair & Recon (CPT Codes 25310, 25447,
2X005, and 26480)
In September 2022, the RUC referred CPT codes 26480 and 25447 to
the CPT Editorial Panel for a code bundling solution. In May 2023, the
CPT Editorial Panel approved a new bundled code (CPT code 2X005) to
report intercarpal or carpometacarpal joint suspension arthroplasty,
including transfer or transplant of tendon, with interposition when
performed while CPT code 25447 was revised to clarify that the code
only included interposition of a tendon and not suspension. This family
of codes was surveyed for the September 2023 RUC meeting.
We disagree with the RUC-recommended work RVU of 9.50 for CPT code
25310 (Tendon transplantation or transfer, flexor or extensor, forearm
and/or wrist, single; each tendon) and we are instead proposing a work
RVU of 9.00 based on the survey 25th percentile result. In reviewing
CPT code 25310, we noted that the recommended intraservice time was
unchanged at 60 minutes in the new survey; however, the RUC-recommended
work RVU is increasing from the current 8.08 to 9.50. Although we do
not imply that changes in work time as reflected in survey values must
equate to a one-to-one or linear change in the valuation of work RVUs,
we believe that since the two components of work are time and
intensity, increases in the recommended work RVU should typically be
reflected in increases in the surveyed work time. We recognize that the
total time for CPT code 25310 is increasing from 235 minutes to 263
minutes (an increase of 12 percent) due to changes in the code's post-
operative office visits which will now take place at a higher level.
However, this again does not match the increase in the recommended work
RVU, which is increasing from 8.08 to 9.50 (approximately 18 percent).
We believe that it would be more accurate to propose the survey 25th
percentile work RVU of 9.00 for CPT code 25310 which matches this
increase in the total work time. We also note that the intensity of CPT
code 25310 is decreasing, not increasing, as recommended by the RUC
which further suggests that a work RVU of 9.50 would not be appropriate
for this code given the surveyed work times.
We disagree with the RUC-recommended work RVU of 11.14 for CPT code
25447 (Arthroplasty, intercarpal or carpometacarpal joints;
interposition (eg, tendon)) and we are instead proposing a work RVU of
10.50 based on the survey 25th percentile result. In reviewing CPT code
25447, we noted that the recommended intraservice time was decreasing
from 100 minutes to 75 minutes in the new survey; however, the RUC
recommended maintaining the current work RVU of 11.14. Although we do
not imply that changes in work time as reflected in survey values must
equate to a one-to-one or linear change in the valuation of work RVUs,
we believe that since the two components of work are time and
intensity, decreases in the surveyed work time should typically be
reflected in decreases to the work RVU. We recognize that the total
time for CPT code 25447 is slightly increasing from 278 minutes to 281
minutes (an increase of about 1 percent) due to changes in the code's
post-operative office visits which will now take place at a higher
level. However, we believe that the sizable decrease in surveyed
intraservice work time (a reduction of approximately 33 percent) better
supports proposing the survey 25th percentile work RVU of 10.50 instead
of maintaining the current work RVU of 11.14. We also disagree with the
RUC that the intensity of CPT code 25447 is unchanged due to increases
in the post-operative work; we believe that the sizable decrease in
surveyed intraservice work time indicates a modest decrease in
intensity. We note again that the intensity of CPT code 25310 is
decreasing, not increasing, as recommended by the RUC which suggests
that a similar pattern is likely taking place with clinically similar
procedures elsewhere in the same code family.
We disagree with the RUC-recommended work RVU of 13.90 for CPT code
2X005 (Arthroplasty, intercarpal or carpometacarpal joints; suspension,
including transfer or transplant of tendon, with interposition, when
performed) and we are instead proposing a work RVU of 11.85 based on
the survey 25th percentile result. We note that the RUC typically
values new codes such as CPT code 2X005 using this survey 25th
percentile work RVU as opposed to the survey median work RVU that it
recommended. The RUC's recommendations stated that CPT code 2X005
should be valued higher than CPT code 25447 due to having higher
intensity, a relationship which is preserved at our proposed work RVUs
of 11.85 and 10.50 respectively. The RUC also stated in its
recommendations that CPT code 2X005 should be valued higher than
reference CPT code 29828 (Arthroscopy, shoulder, surgical; biceps
tenodesis) because it has more intraservice time and total work time.
However, the RUC also stated elsewhere in its recommendations that the
arthroscopy described by CPT code 29828 is more intense than the
arthroplasty procedures described by this family of codes, which we
believe supports CPT code 29828 having a higher work RVU despite its
lower work times. Based on this information, we believe that proposing
the survey 25th percentile work RVU of 11.85 is the most accurate
valuation for CPT code 2X005.
We disagree with the RUC-recommended work RVU of 9.50 for CPT code
26480 (Transfer or transplant of tendon, carpometacarpal area or dorsum
of hand; without free graft, each tendon) and we are instead proposing
a work RVU of 9.00 based on the survey 25th percentile result. In
reviewing CPT code 26480, we noted that the recommended intraservice
time was unchanged at 60 minutes in the new survey; however, the RUC-
recommended work RVU is increasing from the current 6.90 to 9.50.
Although we do not imply that changes in work time as reflected in
survey values must equate to a one-to-one or linear change in the
valuation of work RVUs, we believe that since the two components of
work are time and intensity, increases in the recommended work RVU
should typically be reflected in increases in the surveyed work time.
We recognize that the total time for CPT code 26480 is increasing from
227 minutes to 263 minutes (an increase of 16 percent) due to changes
in the code's post-operative office visits which will now take place at
a higher level. However, this again does not match the increase in the
recommended work RVU, which is increasing from 6.90 to 9.50
(approximately 38 percent). We believe that it would be more accurate
to propose the survey 25th percentile work RVU of 9.00 for CPT code
26480 which more closely matches this increase in the total work time.
We also note that CPT codes 25310 and 26480 were surveyed as having
identical work times and identical survey 25th percentile and survey
median work RVUs. We concur with the RUC that these two codes should be
valued at the same work RVU, however we continue to believe that the
survey 25th percentile work RVU of 9.00 is a more accurate choice in
both cases. We are proposing the RUC-recommended direct PE inputs for
all four codes in the family without refinement.
[[Page 61645]]
(3) CAR-T Therapy Services (CPT Codes 3X018, 3X019, 3X020, and 3X021)
In September 2023, the CPT Editorial Panel deleted four category
III codes (0537T-0540T) and approved the addition of four new codes
(3X018-3X021) that describe only steps of the complex CAR-T Therapy
process performed and supervised by physicians. The RUC recommended
four different work RVUs for codes 3X018, 3X019, 3X020, and 3X021 and
only recommended direct PE values for code 3X021.
For CPT code 3X018 (Chimeric antigen receptor T-cell (CAR-T)
therapy; harvesting of blood-derived T lymphocytes for development of
genetically modified autologous CAR-T cells, per day) the RUC
recommended a work RVU of 1.94. For CPT code 3X019 (Chimeric antigen
receptor T-cell (CAR-T) therapy; preparation of blood-derived T
lymphocytes for transportation (eg, cryopreservation, storage)) the RUC
recommended a work RVU of 0.79. For CPT code 3X021 (Chimeric antigen
receptor T-cell (CAR-T) therapy; CAR-T cell administration, autologous)
the RUC recommended a work RVU of 3.00. For CPT code 3X020 (Chimeric
antigen receptor T-cell (CAR-T) therapy; receipt and preparation of
CAR-T cells for administration) the RUC recommended a work RVU of 0.80
and for CPT code 3X020, we are proposing the RUC-recommended work RVU
of 0.80. We are proposing the RUC-recommended work RVUs for CPT codes
3X018, 3X019, and 3X021 respectively.
As mentioned previously, the RUC recommended direct PE values for
only one code, CPT code 3X021, and the RUC recommended that the non-
facility PE RVU for CPT codes 3X018-3X020 should be contractor-priced.
However, contractor pricing can only be applied at the whole code
level, not to a single component of the valuation. Therefore, for CPT
codes 3X018-3X020 we are treating these codes as having no recommended
direct PE values and are seeking comment on direct PE values for these
codes. We are proposing the RUC-recommended direct PE inputs for CPT
code 3X021.
(4) Therapeutic Apheresis and Photopheresis (CPT Codes 36514, 36516,
and 36522)
In the CY 2024 PFS final rule, we finalized 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) as potentially misvalued, as we
believed there may have been a possible disparity with the clinical
labor type (88 FR 78848). As a result, the PE clinical labor type was
reviewed for these three codes at the January 2024 RUC meeting, with no
work review. The PE Subcommittee and the RUC agreed that clinical staff
code L042A (RN/LPN) did not appropriately represent the work of an
Apheresis Nurse Specialist. There is not a clinical staff code for an
Apheresis Nurse Specialist; however, the RUC agreed with the specialty
societies' recommendation that the training and experience of an
oncology nurse (clinical staff code L056A, RN/OCN) would more
accurately reflect the work of an apheresis nurse for these CPT codes.
The RUC submitted new PE recommendations for these three codes based on
the use of the L056A clinical labor type.
We are proposing the RUC-recommended direct PE inputs for CPT codes
36514, 36516, and 36522 without refinement. The RUC did not make
recommendations and we are not proposing any changes to the work RVU
for CPT codes 36514, 36516, and 36522.
(5) Intra-Abdominal Tumor Excision or Destruction (CPT Codes 4X015,
4X016, 4X017, 4X018, and 4X019)
In May 2023, the CPT Editorial Panel created five new codes to
describe the sum of the maximum length of intra-abdominal (that is,
peritoneal, mesenteric, retroperitoneal), primary or secondary tumor(s)
or cyst(s) excised or destroyed: CPT code 4X015 (Excision or
destruction, open, intra-abdominal (i.e., peritoneal, mesenteric,
retroperitoneal), primary or secondary tumor(s) or cyst(s), sum of the
maximum length of tumor(s) or cyst(s); 5 cm or less), CPT code 4X016
(Excision or destruction, open, intra-abdominal (i.e., peritoneal,
mesenteric, retroperitoneal), primary or secondary tumor(s) or cyst(s),
sum of the maximum length of tumor(s) or cyst(s); 5.1 to 10 cm), CPT
code 4X017 (Excision or destruction, open, intra-abdominal (i.e.,
peritoneal, mesenteric, retroperitoneal), primary or secondary tumor(s)
or cyst(s), sum of the maximum length of tumor(s) or cyst(s); 10.1 to
20 cm), CPT code 4X018 (Excision or destruction, open, intra-abdominal
(i.e., peritoneal, mesenteric, retroperitoneal), primary or secondary
tumor(s) or cyst(s), sum of the maximum length of tumor(s) or cyst(s);
20.1 to 30 cm), and CPT code 4X019 (Excision or destruction, open,
intra-abdominal (i.e., peritoneal, mesenteric, retroperitoneal),
primary or secondary tumor(s) or cyst(s), sum of the maximum length of
tumor(s) or cyst(s); greater than 30 cm). These new CPT codes will
replace existing CPT codes 49203 (Excision or destruction, open, intra-
abdominal tumors, cysts or endometriomas, 1 or more peritoneal,
mesenteric, or retroperitoneal primary or secondary tumors; largest
tumor 5 cm diameter or less), 49204 (Excision or destruction, open,
intra-abdominal tumors, cysts or endometriomas, 1 or more peritoneal,
mesenteric, or retroperitoneal primary or secondary tumors; largest
tumor 5.1-10.0 cm diameter), and 49205 (Excision or destruction, open,
intra-abdominal tumors, cysts or endometriomas, 1 or more peritoneal,
mesenteric, or retroperitoneal primary or secondary tumors; largest
tumor greater than 10.0 cm diameter) that described tumor excision or
destruction based on the size of the single largest tumor, cyst, or
endometrioma removed, no matter the number of tumors. For CY 2025, the
RUC recommended a work RVU of 22.00 for CPT code 4X015, a work RVU of
28.65 for CPT code 4X016, a work RVU of 34.00 for CPT code 4X017, a
work RVU of 45.00 for CPT code 4X018, and a work RVU of 55.00 for CPT
code 4X019.
We are proposing the RUC-recommended work RVUs of 22.00 for CPT
code 4X015, 28.65 for CPT code 4X016, and 34.00 for CPT code 4X017.
We disagree with the RUC-recommended work RVU of 45.00 for CPT code
4X018 and we are proposing a work RVU of 40.00 based on the survey 25th
percentile. Compared to the predecessor CPT code 49205, the intra-
service time ratio for CPT code 4X018 suggests a work RVU of 41.51 and
the total time ratio suggests a work RVU of 38.02. These changes in
surveyed work time as compared with predecessor CPT code 49205 suggest
that the recommended work RVU of 45.00 is inappropriately high. We also
note that the RUC recommended the survey 25th percentile work RVU for
CPT codes 4X015, 4X016, and 4X017. Therefore, we believe that proposing
a work RVU of 40.00 for CPT code 4X018 keeps the valuation consistent
with the other CPT codes in this family. Our proposed work RVU of 40.00
for CPT code 4X018 is supported by the following reference CPT codes
with similar intra-service time (310 minutes) and similar total time
(814 minutes): reference CPT code 69970 (Removal of tumor, temporal
bone) with a work RVU of 32.41 with 330 minutes intra-service time and
793 minutes of total time, and reference CPT code 33864 (Ascending
aorta graft, with cardiopulmonary bypass with valve suspension, with
coronary reconstruction and valve-sparing aortic root remodeling (e.g.,
David Procedure,
[[Page 61646]]
Yacoub Procedure)) with a work RVU of 60.80 with 300 minutes of intra-
service time and 838 minutes of total time. We believe the proposed
work RVU of 40.00 is a more appropriate value overall than 45.00 when
compared to the range of codes with similar intra-service time and
similar total time.
We disagree with the RUC-recommended work RVU of 55.00 for CPT code
4X019 and we are proposing a work RVU of 50.00 based on the survey 25th
percentile. Compared to the predecessor CPT code 49205, the intra-
service time ratio for CPT code 4X019 suggests a work RVU of 48.21 and
the total time ratio suggests a work RVU of 48.86. These changes in
surveyed work time as compared with predecessor CPT code 49205 suggest
that the recommended work RVU of 55.00 is inappropriately high. We also
note again that the RUC recommended the survey 25th percentile work RVU
for CPT codes 4X015, 4X016, and 4X017. Therefore, we believe that
proposing a work RVU of 50.00 for CPT code 4X019 keeps the valuation
consistent with the other CPT codes in this family. Our proposed work
RVU of 50.00 for CPT code 4X019 is supported by the following reference
CPT codes with similar intra-service time (360 minutes) and similar
total time (1,046 minutes): reference CPT code 61598 (Transpetrosal
approach to posterior cranial fossa, clivus or foramen magnum,
including ligation of superior petrosal sinus and/or sigmoid sinus)
with a work RVU of 36.53 with 377.7 minutes intra-service time and
1,048.1 minutes of total time, and reference CPT code 47140 (Donor
hepatectomy (including cold preservation), from living donor; left
lateral segment only (segments II and III)) with a work RVU of 59.40
with 355 minutes of intra-service time and 1,073 minutes of total time.
We believe the proposed RVU of 50.00 is a more appropriate value
overall than 55.00 when compared to the range of codes with similar
intra-service time and similar total time.
We also note that the RUC's recommendations for the first three
codes in the family (CPT codes 4X015-4X017) maintained the same amount
of intensity as their respective predecessor codes, and in fact
slightly decreased in intensity in the case of CPT codes 4X015 and
4X016. However, the RUC recommended a notable increase in intensity for
CPT codes 4X018 and 4X019 over predecessor code 49205 due to its
selection of the survey median work RVU in both cases. We do not
believe that this increase in intensity for CPT codes 4X018 and 4X019
is warranted due to their clinical similarities to the previous coding
in the family, especially given that CPT code 49205 had the lowest
intensity in the family. We believe that this intensity argument
further supports our choice to propose the survey 25th percentile work
RVU for these two codes, matching the RUC recommendations for CPT code
4X015-4X017.
We are proposing the RUC-recommended direct PE inputs for CPT codes
4X015, 4X016, 4X017, 4X018, and 4X019 without refinement.
(6) Bladder Neck and Prostate Procedures (CPT Codes 5XX05 and 5XX06)
In September 2023, the CPT Editorial Panel created two Category I
CPT codes to describe the insertion or removal of a temporary device to
remodel the bladder neck and prostate using pressure to create necrosis
and relieve lower urinary tract symptoms (LUTS) secondary to benign
prostate hyperplasia (BPH). These two new 000-day global Category I
codes were surveyed and reviewed for the January 2024 RUC meeting.
At the January 2024 RUC meeting, the specialty society indicated
that CPT code 5XX05's survey 25th percentile work RVU of 3.91 was too
high for this procedure compared to other services in the physician fee
schedule with similar intra-service time. The specialty society
recommended, and the RUC agreed that the recommended work RVU for CPT
code 5XX05 should be crosswalked to CPT code 52284 (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). Because these
procedures are similar in intensity and both require precise placement
of an intraurethral device, we concur with the RUC and we are proposing
the RUC recommended work RVU of 3.10 for CPT code 5XX05.
At the January 2024 RUC meeting, the specialty society indicated
that CPT code 5XX06's survey 25th percentile work RVU of 2.00 was too
high for this procedure compared to other services in the physician fee
schedule with similar intra-service time. The specialty society
recommended, and the RUC agreed, that CPT code 5XX06 should have a
direct work RVU crosswalk to CPT code 27096 (Injection procedure for
sacroiliac joint, anesthetic/steroid, with image guidance (fluoroscopy
or CT) including arthrography when performed). We are proposing the RUC
recommended work RVU of 1.48 for CPT code 5XX06.
We are also proposing the RUC-recommended direct PE inputs for CPT
codes 5XX05 and 5XX06 without refinement. However, we note possible
duplications in two of the supply items within CPT code 5XX05.
Specifically, supply item SB027 (gown, staff, impervious) is already
included in supply item SA042 (pack, cleaning and disinfecting,
endoscope), and supply item SB024 (gloves, sterile) is included in
supply items SA058 (pack, urology cystoscopy visit). We are seeking
comments on whether a total of three SB027 impervious staff gowns and
two SB024 pairs of sterile gloves would be typical and necessary when
providing this procedure.
(7) MRI-Monitored Transurethral Ultrasound Ablation of Prostate (CPT
Codes 5X006, 5X007, and 5X008)
At the April 2023 CPT Editorial Panel meeting, three new CPT codes
were approved for MRI-monitored transurethral ultrasound ablation
(TULSA). These codes were surveyed for the September 2023 RUC meeting
and recommendations submitted to CMS for inclusion in the CY 2025 PFS
proposed rule.
For CY 2025, we are proposing the RUC-recommended work RVUs for all
three CPT codes. However, we note that interested parties may have
concerns regarding the experience of the survey respondents and the
intra-service times provided in the survey data. We welcome commenters
to provide additional data that we could consider in the valuation of
the work and direct PE inputs for these CPT codes. We are proposing a
work RVU of 4.05 for CPT code 5X006 (Insertion of transurethral
ablation transducers for delivery of thermal ultrasound for prostate
tissue ablation, including suprapubic tube placement during the same
session and placement of an endorectal cooling device, when performed),
a work RVU of 9.80 for CPT code 5X007 (Ablation of prostate tissue,
transurethral, using thermal ultrasound, including magnetic resonance
imaging guidance for, and monitoring of, tissue ablation), and a work
RVU of 11.50 for CPT code 5X008 (Ablation of prostate tissue,
transurethral, using thermal ultrasound, including magnetic resonance
imaging guidance for, and monitoring of, tissue ablation; with
insertion of transurethral ultrasound transducers for delivery of the
thermal ultrasound, including suprapubic tube placement and placement
of an endorectal cooling device, when performed). We are also proposing
the RUC-recommended direct PE inputs for CPT codes 5X006, 5X007, and
5X008 without refinement.
[[Page 61647]]
(8) Insertion of Cervical Dilator (CPT Code 59200)
In the CY 2024 PFS final rule, we finalized CPT Code 59200
(Insertion of cervical dilator (e.g., laminaria, prostaglandin)
(separate procedure)) as potentially misvalued. The code is to be used
to report the total duration of time spent on a patient history and
physical, reviewing lab resulting, discussing risk and benefits of the
procedure, obtaining consent, performing the procedure, and assessing
the patient post-procedure. The RUC reviewed the work RVU and PE inputs
for CPT code 59200 at their January 2024 meeting. We are proposing the
RUC-recommended work RVU of 1.20 for CPT code 59200. We are also
proposing the RUC-recommended direct PE inputs for CPT code 59200
without refinements.
(9) Guided High Intensity Focused Ultrasound (CPT Code 6XX00)
In September 2023, the CPT Editorial Panel created a new Category I
code to describe magnetic resonance image guided high intensity focused
ultrasound intracranial ablation for treatment of a severe central
tremor that is recalcitrant to other medical treatments. This service
is typically performed by a neurosurgeon without the involvement of a
separate radiologist. This new code replaces the existing Category III
code 0398T.
We are not proposing the RUC-recommended work RVU of 18.95 for CPT
code 6XX00 and are instead proposing a work RVU of 16.60 based on a
crosswalk to CPT code 61626 (Transcatheter permanent occlusion or
embolization (e.g., for tumor destruction, to achieve hemostasis, to
occlude a vascular malformation), percutaneous, any method; non-central
nervous system, head or neck (extracranial, brachiocephalic branch)),
which describes a similar tumor destruction service that has similar
time and intensity values to this service, and we support this value by
referencing CPT code 33889 (Open subclavian to carotid artery
transposition performed in conjunction with endovascular repair of
descending thoracic aorta, by neck incision, unilateral) and 33894
(Endovascular stent repair of coarctation of the ascending, transverse,
or descending thoracic or abdominal aorta, involving stent placement;
across major side branches). We do not believe that this service is
significantly more intense than the key reference codes, CPT codes
61736 (Laser interstitial thermal therapy (LITT) of lesion,
intracranial, including burr hole(s), with magnetic resonance imaging
guidance, when performed; single trajectory for 1 simple lesion) and
61737 (Laser interstitial thermal therapy (LITT) of lesion,
intracranial, including burr hole(s), with magnetic resonance imaging
guidance, when performed; multiple trajectories for multiple or complex
lesion(s)), as the RUC-recommended work value implies. Our proposed
work RVU of 16.60 for CPT code 6XX00 largely matches the intensity of
CPT code 61736 which we believe is a more accurate valuation for this
service, as opposed to the RUC recommendation which would have
significantly more intensity.
We are proposing the RUC-recommended direct PE inputs for CPT code
6XX00 without refinement.
(10) Percutaneous Radiofrequency Ablation of Thyroid (CPT Codes 6XX01
and 6XX02)
In January 2024, the RUC surveyed codes 6XX01 (Ablation of 1 or
more thyroid nodule(s), one lobe or the isthmus, percutaneous,
including imaging guidance, radiofrequency) and its respective add-on
code 6XX02 (Ablation of 1 or more thyroid nodule(s), additional lobe,
percutaneous, with imaging guidance, radiofrequency (List separately in
addition to code for primary service) and recommended both work RVUs
and PE values for this code family.
For CPT code 6XX01, the RUC recommended a work RVU of 5.75 and we
are proposing the RUC-recommended work RVU of 5.75.
For add-on code CPT 6XX02, the RUC recommended a work RVU of 4.25
and we are proposing the RUC-recommended work RVU for this code. We are
also proposing the RUC-recommended direct PE values for both codes
6XX01 and 6XX02.
(11) Fascial Plane Blocks (CPT Codes 6XX07, 6XX08, 6XX09, 6XX10, 6XX11,
6XX12, 64486, 64487, 64488, and 64489)
In September 2023, the CPT Editorial Panel created six new Category
I CPT codes, CPT code 6XX07 (Thoracic fascial plane block, unilateral;
by injection(s), including imaging guidance, when performed), 6XX08
(Thoracic fascial plane block, unilateral; by continuous infusion(s),
including imaging guidance, when performed), 6XX09 (Thoracic fascial
plane block, bilateral; by injection(s), including imaging guidance,
when performed), 6XX10 (Thoracic fascial plane block, bilateral; by
continuous infusion(s), including imaging guidance, when performed),
6XX11 (Lower extremity fascial plane block, unilateral; by
injection(s), including imaging guidance, when performed), and 6XX12
(Lower extremity fascial plane block, unilateral; by continuous
infusion(s), including imaging guidance, when performed) to report
thoracic or lower extremity fascial plane blocks, typically used for
post-operative pain management. Four existing CPT codes describing
transversus abdominis plane (TAP) blocks, 64486 (Transversus abdominis
plane (TAP) block (abdominal plane block, rectus sheath block)
unilateral; by injection(s) (includes imaging guidance, when
performed)), 64487 (Transversus abdominis plane (TAP) block (abdominal
plane block, rectus sheath block) unilateral; by continuous infusion(s)
(includes imaging guidance, when performed)), 64488 (Transversus
abdominis plane (TAP) block (abdominal plane block, rectus sheath
block) bilateral; by injections (includes imaging guidance, when
performed)) 64489 (Transversus abdominis plane (TAP) block (abdominal
plane block, rectus sheath block) bilateral; by continuous infusions
(includes imaging guidance, when performed)), were included as part of
this code family for RUC review in January 2024.
We are proposing the RUC-recommended work RVU for all ten codes in
this family. We are proposing a work RVU of 1.50 for CPT code 6XX07,
1.74 for CPT code 6XX08, 1.67 for CPT code 6XX09, 1.83 for CPT code
6XX10, 1.34 for CPT code 6XX11, 1.67 for CPT code 6XX12, 1.20 for CPT
code 64486, 1.39 for CPT code 64487, 1.40 for CPT code 64488, and 1.75
for CPT code 64489.
We are also proposing the RUC recommended direct PE inputs for CPT
codes 6XX08, 6XX09, 6XX10, 6XX12, 64487, 64488, and 64489. We disagree
with one of the RUC recommended direct PE inputs for CPT codes 6XX07,
6XX11, and 64486. The RUC stated they believe that there is a rounding
error in the CA019 clinical labor time, ``Assist physician or other
qualified healthcare professional--directly related to physician work
time (67%)'', for these three codes. We disagree with the RUC that
there are rounding errors in these codes and we are proposing to
maintain the current 7 minutes of CA019 clinical labor time for CPT
codes 6XX07, 6XX11, and 64486. We note that this matches the pattern of
CA019 clinical labor time for the rest of the codes in the family,
which remained the same or slightly decreased in each case. This
refinement to the CA019 clinical labor time also means that we are
proposing a decrease of 0.5 minutes to the equipment time for the
stretcher (EF018) and 3-channel ECG
[[Page 61648]]
(EQ011) which decreases from 25.5 to 25 minutes for these three codes.
We are proposing all of the other RUC-recommended direct PE inputs for
CPT codes 6XX07, 6XX11, and 64486 without refinement.
(12) Skin Adhesives (CPT Codes 64590 and 64595 and HCPCS Codes G0168,
G0516, G0517, and G0518)
In April 2022, the RUC approved the use of SG007 (adhesive, skin
(Dermabond)) for CPT code 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). In April
2023, the PE Subcommittee reviewed the following six codes on the
Medicare Physician Fee Schedule 64590, 64595, G0168, G0516, G0517,
G0518 that utilize Dermabond (supply code S6007) in order to identify
justification for its use versus the generic version and present its
findings to the RUC for approval. The RUC reviewed all six codes for PE
only and did not submit work recommendations.
For CPT codes 64590 and 64595 and HCPCS code G0168 (Wound closure
utilizing tissue adhesive(s) only), the RUC recommends that CMS remove
the supply input SG007 adhesive, skin (Dermabond) and add one unit of
SH076 adhesive, cyanoacrylate (2ml uou). We are proposing the RUC-
recommended direct PE inputs for CPT codes 64590 and 64595 and HCPCS
code G0168. Similarly, for HCPCS codes G0516 (Insertion of non-
biodegradable drug delivery implants, 4 or more (services for subdermal
rod implant), G0517 (Removal of non-biodegradable drug delivery
implants, 4 or more (services for subdermal implants), and G0518
(Removal with reinsertion, non-biodegradable drug delivery implants, 4
or more (services for subdermal implants), the RUC recommends that CMS
remove the supply input SG007 adhesive, skin (Dermabond) and add one
unit of SH076 adhesive, cyanoacrylate (2ml uou). We are proposing the
RUC-recommended direct PE inputs for HCPCS codes G0516-G0518.
(13) Iris Procedures (CPT Codes 66680, 66682, and 6X004)
In April 2023, the CPT Editorial Panel deleted three related
Category III CPT codes, CPT code 0616T (Insertion of iris prosthesis,
including suture fixation and repair or removal of iris, when
performed; without removal of crystalline lens or intraocular lens,
without insertion of intraocular lens), CPT code 0617T (with removal of
crystalline lens and insertion of intraocular lens), and CPT code 0618T
(with secondary intraocular lens placement or intraocular lens
exchange). At the same time, CPT created a new Category I code 6X004
(Implantation of iris prosthesis, including suture fixation and repair
or removal of iris, when performed) which describes insertion of an
artificial iris into an eye with a partial or complete iris defect due
to a congenital defect or surgical or non-surgical trauma. The new
Category I CPT code 6X004 replaced the three Category III codes to
simplify reporting. Concurrent with these updates, the RUC surveyed the
two other 90-day global iris repair codes, CPT code 66680 (Repair of
iris, ciliary body (as for iridodialysis)) and CPT code 66682 (Suture
of iris, ciliary body (separate procedure) with retrieval of suture
through small incision (e.g., McCannel suture)).
We disagree with the RUC-recommended work RVU of 10.25 for CPT code
66680. We are proposing a work RVU of 7.97 for CPT code 66680 based on
a crosswalk to CPT code 67904 (Repair of blepharoptosis; (tarso)
levator resection or advancement, external approach). When we reviewed
CPT code 66680, we found that the RUC recommended work RVU does not
maintain relativity with other 90-day global period codes with the same
intraservice time of 45 minutes and similar total time around 182
minutes. The total time ratio between the current time of 159 minutes
and the recommended time established by the RUC survey of 182 minutes
equals 1.145 percent. This ratio, 1.145 percent, when applied to the
current work RVU of 6.39 would suggest a work RVU of 7.31 which is far
below the RUC's recommended work RVU of 10.25. Based on this total time
ratio, we believe a more appropriate work valuation for CPT code 66680
is 7.97 based on a crosswalk to CPT code 67904.
We disagree with the RUC-recommended work RVU of 10.87 for CPT code
66682. We are proposing a work RVU of 8.74 based on the total time
ratio between the current time of 169.5 minutes and the recommended
time established by the RUC survey of 202 minutes. This ratio equals
1.192 percent, and 1.192 percent of the current work RVU of 7.33
suggests a work RVU of 8.74 for CPT code 66682. When we reviewed CPT
code 66682, we found that the recommended work RVU was higher than
nearly all of the other 90-day global codes with similar time values.
The RUC's recommended work RVU does not maintain relativity with other
90-day global period codes with the same intraservice time value of 45
minutes and similar total time of 202. We found that work RVU
crosswalks to CPT codes of similar intraservice and total time were too
low, such as CPT code 45171 with a work RVU of 8.13. A more appropriate
work RVU for CPT code 66682 is 8.74 based on the total time ratio.
The RUC recommended a work RVU of 12.80 for CPT 6X004, the RUC
survey 25th percentile result, with an intraservice time of 60 minutes
and a total time of 224 minutes. We disagree with the RUC-recommended
work RVU of 12.80 for CPT code 6X004. Although we disagree with the
RUC-recommended work RVU, we concur that the relative difference in
work between CPT codes 66682 and 6X004 is equivalent to the recommended
interval of 1.93 RVUs. Therefore, we are proposing a work RVU of 10.67
for CPT code 6X004, based on the recommended interval of 1.93
additional RVUs above our proposed work RVU of 8.74 for CPT code 66682.
This proposed work RVU of 10.67 falls between the work RVU values of
existing codes with similar intraservice and total time values. For
example, CPT code 65850 (60 minutes of intraservice time and 233
minutes of total time) has a work RVU of 11.39 and CPT code 24164 with
the same intraservice time and 228 minutes of total time has a work RVU
of 10.00. We believe that the work valuation of these CPT codes, which
bracket our proposed work RVU of 10.67, provide additional support for
our proposed valuation.
We also disagree with the RUC's recommended work RVUs for the codes
in this family because they suggest that there has been a tremendous
increase in intensity as compared to how these services have
historically been valued. CPT code 66680 is more than doubling in
intensity at the RUC's recommended work RVU of 10.25, which we do not
believe to be the case given that the code descriptor remains unchanged
and the surveyed intraservice work time is unchanged at 45 minutes.
This same pattern holds true for CPT code 66682, which would be
increasing in intensity by more than 50% at the RUC's recommended work
RVU of 10.87, and which similarly has no change in its code descriptor
and a modest increase in its surveyed work time. We concur that the
intensity of these services has likely gone up over time, which is why
we are proposing modest intensity increases for both codes, however we
continue to disagree that the very
[[Page 61649]]
substantial intensity increases recommended by the RUC would be
accurate for this code family. We believe that our proposed work RVUs
are more in line with how these services have historically been valued
and better maintain relativity with the rest of the fee schedule.
We are proposing the direct PE inputs as recommended by the RUC for
all three codes in the family without refinement.
(14) Magnetic Resonance Examination Safety Procedures (CPT Codes 7XX00,
7XX01, 7XX02, 7XX03, 7XX04, and 7XX05)
In September 2023, the CPT Editorial Panel created a new code
family to describe magnetic resonance (MR) examination safety
procedures and capture the physician work involving patients with
implanted medical devices that require access to MR diagnostic
procedures: CPT code 7XX00 (MR safety implant and/or foreign body
assessment by trained clinical staff, including identification and
verification of implant components from appropriate sources (e.g.,
surgical reports, imaging reports, medical device databases, device
vendors, review of prior imaging), analyzing current MR conditional
status of individual components and systems, and consulting published
professional guidance with written report; initial 15 minutes), CPT
code 7XX01 (MR safety implant and/or foreign body assessment by trained
clinical staff, including identification and verification of implant
components from appropriate sources (e.g., surgical reports, imaging
reports, medical device databases, device vendors, review of prior
imaging), analyzing current MR conditional status of individual
components and systems, and consulting published professional guidance
with written report; each additional 30 minutes (List separately in
addition to code for primary procedure)), CPT code 7XX02 (MR safety
determination by a physician or other qualified health care
professional responsible for the safety of the MR procedure, including
review of implant MR conditions for indicated MR exam, analysis of risk
versus clinical benefit of performing MR exam, and determination of MR
equipment, accessory equipment, and expertise required to perform
examination with written report), CPT code 7XX03 (MR safety medical
physics examination customization, planning and performance monitoring
by medical physicist or MR safety expert, with review and analysis by
physician or qualified health care professional to prioritize and
select views and imaging sequences, to tailor MR acquisition specific
to restrictive requirements or artifacts associated with MR conditional
implants or to mitigate risk of non-conditional implants or foreign
bodies with written report), CPT code 7XX04 (MR safety implant
electronics preparation under supervision of physician or other
qualified health care professional, including MR-specific programming
of pulse generator and/or transmitter to verify device integrity,
protection of device internal circuitry from MR electromagnetic fields,
and protection of patient from risks of unintended stimulation or
heating while in the MR room with written report), and CPT code 7XX05
(MR safety implant positioning and/or immobilization under supervision
of physician or qualified health care professional, including
application of physical protections to secure implanted medical device
from MR-induced translational or vibrational forces, magnetically
induced functional changes, and/or prevention of radiofrequency burns
from inadvertent tissue contact while in the MR room with written
report). For CY 2025, new CPT codes 7XX00 and 7XX01 are PE only
services that represent the preparatory research and review completed
by clinical staff (that is, MRI technologist and/or a medical
physicist) that will be utilized by the physician or qualified health
professional for the other four services (CPT codes 7XX02, 7XX03,
7XX04, and 7XX05) in this code family.
We are proposing the RUC-recommended work RVU of 0.60 for CPT code
7XX02, the work RVU of 0.76 for CPT code 7XX03, the work RVU of 0.75
for CPT code 7XX04, and the work RVU of 0.60 for CPT code 7XX05.
We are proposing the following refinements to the direct PE inputs.
For CPT codes 7XX00, 7XX01, 7XX02, 7XX04, and 7XX05, we are proposing
to refine the clinical labor for the CA034 activity (Document procedure
(nonPACS) (e.g., mandated reporting, registry logs, EEG file, etc.))
performed by the MRI Technologist from 2 minutes to 1 minute. We note
that the clinical labor for the CA032 activity (Scan exam documents
into PACS. Complete exam in RIS system to populate images into work
queue.) included in the direct PE inputs for reference CPT code 70543
(Magnetic resonance (e.g., proton) imaging, orbit, face, and/or neck;
without contrast material(s), followed by contrast material(s) and
further sequences) is a similar clinical labor activity and has 1
minute of time. We also note that the Medical Physicist has 1 minute of
recommended clinical labor time for the CA034 activity for CPT code
7XX03. Therefore, we believe that the MRI Technologist should have the
same time (1 minute) for the CA034 activity for the remaining codes in
the family to maintain consistency across these services.
For CPT code 7XX01, we are proposing to refine the clinical labor
for the CA021 activity (Perform procedure/service--NOT directly related
to physician work time) from 27 minutes to 14 minutes. We believe this
clinical labor time should be double the 7 minutes assigned to the
CA021 activity for CPT code 7XX00. The description for CPT code 7XX00
is for the ``initial 15 minutes'' and CPT code 7XX01 is for ``each
additional 30 minutes,'' that is, double the time of CPT code 7XX00. We
believe that the clinical labor associated with the CA021 activity
should match this pattern in which CPT code 7XX01 contains double the
time of CPT code 7XX00. This proposed refinement to the CA021 clinical
labor also results in a proposed decrease to the equipment time for the
Technologist PACS workstation (ED050) from 45 minutes to 32 minutes.
For CPT code 7XX03, the RUC recommended 13 minutes of equipment
time for the Professional PACS Workstation (ED053) listed as a Facility
PE input. We believe this was an unintended technical error and we are
proposing to remove this time from the direct PE inputs for CPT code
7XX03.
For CPT codes 7XX04 and 7XX05, we proposing to refine the clinical
labor time for the CA024 activity (Clean room/equipment by clinical
staff) from 2 minutes to 1 minute. According to the PE recommendations,
only the new equipment code EQ412 (Vitals monitoring system (MR
Conditional)) is being cleaned and not the entire room. We believe that
1 minute of clinical labor time would be typical for cleaning the EQ412
equipment. Our proposed clinical labor refinement also results in a
proposed decrease to the equipment time for EL008 (room, MR) and EQ412
by 1 minute for these two codes.
For CPT code 7XX05, we are proposing to remove supply item SL082
(impression material, dental putty (per bite block)). We believe this
was an error since the PE recommendations did not list SL082 as one of
the included supplies for CPT code 7XX05 and it does not appear as a
supply input for any of the other codes in the family.
(15) Screening Virtual Colonoscopy (CPT Code 74263)
As discussed in section III.K. of this proposed rule, we are
proposing to exercise our authority at section
[[Page 61650]]
1861(pp)(1)(D) of the Act to update and expand coverage for colorectal
cancer screening and adding coverage for the computed tomography
colonography procedure. Accordingly, we are assigning an active payment
status for CPT code 74263 (Computed tomographic (ct) colonography,
screening, including image postprocessing). We note that, as proposed
above, the OPPS cap would apply to this code, and payment for the TC of
this service would be capped at the OPPS payment rate.
(16) Ultrasound Elastography (CPT Codes 76981, 76982, and 76983)
This code family was flagged for re-review at the April 2023 RUC
meeting by the new technology/new services screen. Due to increased
utilization of CPT code 76981 (Ultrasound, elastography; parenchyma
(e.g., organ)), the entire code family was resurveyed for the September
2023 RUC meeting. We are proposing the RUC-recommended work RVUs of
0.59, 0.59, and 0.47 for CPT codes 76981, 76982 (Ultrasound,
elastography; first target lesion), and 76983 (Ultrasound,
elastography; each additional target lesion (List separately in
addition to code for primary procedure)), respectively. We are
proposing the RUC-recommended direct PE inputs for CPT codes 76981,
76982, and 76983 without refinement.
(17) CT Guidance Needle Placement (CPT Code 77012)
CPT code 77012 (Computed tomography guidance for needle placement
(e.g., biopsy, aspiration, injection, localization device),
radiological supervision and interpretation) was reviewed at the
September 2023 RUC meeting to account for deferred updates to the
vignette to reflect the typical patient until updated utilization data
was available to reflect coding changes that occurred in 2019. We are
proposing the RUC-recommended work RVU of 1.50 for CPT code 77012.
We are proposing to refine the equipment time for the CT room
(EL007) to maintain the current time of 9 minutes. CPT code 77012 is a
radiological supervision and interpretation (RS&I) procedure and there
has been a longstanding convention in the direct PE inputs, shared by
38 other codes, to assign an equipment time of 9 minutes for the
equipment room in these procedures. We made the same refinement in the
CY 2019 PFS final rule (83 FR 59553 through 59554) and continue to
believe that it would not serve the interests of relativity to increase
the equipment time for the CT room in CPT code 77012 without also
addressing the equipment room time for the other radiological
supervision and interpretation procedures. In response to the CY 2019
proposal, several commenters stated that they agreed with CMS that
other RS&I codes use the 9 minutes for room time as a precedent, but
that it is specific to angiographic rooms. We agreed with the
commenters that at least some portion of the procedure is performed in
the CT room, but we continue to believe that it would not serve the
interests of relativity to increase the equipment time for the CT room
in CPT code 77012 without also addressing the equipment room time for
the other radiological supervision and interpretation procedures in a
more comprehensive fashion. We also disagreed with the commenters that
this policy is specific to angiography rooms, as CPT codes 75989
(Radiological guidance (i.e., fluoroscopy, ultrasound, or computed
tomography), for percutaneous drainage (e.g., abscess, specimen
collection), with placement of catheter, radiological supervision and
interpretation) and 77012 both employ CT rooms and currently utilize
the standardized 9 minutes of equipment time, and CPT code 76080
(Radiologic examination, abscess, fistula or sinus tract study,
radiological supervision and interpretation) employs a radiographic-
fluoroscopic room with the 9 minute standard equipment time. We
continue to believe that 9 minutes for EL007 is appropriate for this
RS&I code, therefore, we are proposing to maintain the current
equipment room time of 9 minutes for EL007 until this group of
procedures can be subject to a more comprehensive review. We are
proposing all other RUC-recommended direct PE inputs for CPT code
77012.
(18) Telemedicine Evaluation and Management (E/M) Services (CPT Codes
9X075, 9X076, 9X077, 9X078, 9X079, 9X080, 9X081, 9X082, 9X083, 9X084,
9X085, 9X086, 9X087, 9X088, 9X089, 9X090, and 9X091)
In February 2023, the CPT Editorial Panel added a new Evaluation
and Management (E/M) subsection to the draft CPT codebook for
Telemedicine Services. The Panel added 17 codes for reporting
telemedicine E/M services: CPT code 9X075 (Synchronous audio-video
visit for the evaluation and management of a new patient, which
requires a medically appropriate history and/or examination and
straightforward medical decision making. When using total time on the
date of the encounter for code selection, 15 minutes must be met or
exceeded.); CPT code 9X076 (Synchronous audio-video visit for the
evaluation and management of a new patient, which requires a medically
appropriate history and/or examination and low medical decision making.
When using total time on the date of the encounter for code selection,
30 minutes must be met or exceeded.); CPT code 9X077 (Synchronous
audio-video visit for the evaluation and management of a new patient,
which requires a medically appropriate history and/or examination and
moderate medical decision making. When using total time on the date of
the encounter for code selection, 45 minutes must be met or exceeded.);
CPT code 9X078 (Synchronous audio-video visit for the evaluation and
management of a new patient, which requires a medically appropriate
history and/or examination and high medical decision making. When using
total time on the date of the encounter for code selection, 60 minutes
must be met or exceeded. (For services 75 minutes or longer, use
prolonged services code 99417)); CPT code 9X079 (Synchronous audio-
video visit for the evaluation and management of an established
patient, which requires a medically appropriate history and/or
examination and straightforward medical decision making. When using
total time on the date of the encounter for code selection, 10 minutes
must be met or exceeded.); CPT code 9X080 (Synchronous audio-video
visit for the evaluation and management of an established patient,
which requires a medically appropriate history and/or examination and
low medical decision making. When using total time on the date of the
encounter for code selection, 20 minutes must be met or exceeded.); CPT
code 9X081 (Synchronous audio-video visit for the evaluation and
management of an established patient, which requires a medically
appropriate history and/or examination and moderate medical decision
making. When using total time on the date of the encounter for code
selection, 30 minutes must be met or exceeded.); CPT code 9X082
(Synchronous audio-video visit for the evaluation and management of an
established patient, which requires a medically appropriate history
and/or examination and high medical decision making. When using total
time on the date of the encounter for code selection, 40 minutes must
be met or exceeded.); CPT code 9X083 (Synchronous audio-only visit for
the evaluation and management of a new patient, which requires a
medically appropriate history and/or examination, straightforward
medical decision making, and more
[[Page 61651]]
than 10 minutes of medical discussion. When using total time on the
date of the encounter for code selection, 15 minutes must be met or
exceeded.)); CPT code 9X084 (Synchronous audio-only visit for the
evaluation and management of a new patient, which requires a medically
appropriate history and/or examination, low medical decision making,
and more than 10 minutes of medical discussion. When using total time
on the date of the encounter for code selection, 30 minutes must be met
or exceeded.)); CPT code 9X085 (Synchronous audio-only visit for the
evaluation and management of a new patient, which requires a medically
appropriate history and/or examination, moderate medical decision
making, and more than 10 minutes of medical discussion. When using
total time on the date of the encounter for code selection, 45 minutes
must be met or exceeded.); CPT code 9X086 (Synchronous audio-only visit
for the evaluation and management of a new patient, which requires a
medically appropriate history and/or examination, high medical decision
making, and more than 10 minutes of medical discussion. When using
total time on the date of the encounter for code selection, 60 minutes
must be met or exceeded. (For services 75 minutes or longer, use
prolonged services code 99417)); CPT code 9X087 (Synchronous audio-only
visit for the evaluation and management of an established patient,
which requires a medically appropriate history and/or examination,
straightforward medical decision making, and more than 10 minutes of
medical discussion. When using total time on the date of the encounter
for code selection, 10 minutes must be exceeded.)); CPT code 9X088
(Synchronous audio-only visit for the evaluation and management of an
established patient, which requires a medically appropriate history
and/or examination, low medical decision making, and more than 10
minutes of medical discussion. When using total time on the date of the
encounter for code selection, 20 minutes must be met or exceeded.));
CPT code 9X089 (Synchronous audio-only visit for the evaluation and
management of an established patient, which requires a medically
appropriate history and/or examination, moderate medical decision
making, and more than 10 minutes of medical discussion. When using
total time on the date of the encounter for code selection, 30 minutes
must be met or exceeded.)) CPT code 9X090 (Synchronous audio-only visit
for the evaluation and management of an established patient, which
requires a medically appropriate history and/or examination, high
medical decision making, and more than 10 minutes of medical
discussion. When using total time on the date of the encounter for code
selection, 40 minutes must be met or exceeded. (For services 55 minutes
or longer, use prolonged services code 99417)); CPT code 9X091 (Brief
communication technology-based service (e.g., virtual check-in) by a
physician or other qualified health care professional who can report
evaluation and management services, provided to an established patient,
not originating from a related evaluation and management service
provided within the previous 7 days nor leading to an evaluation and
management service or procedure within the next 24 hours or soonest
available appointment, 5-10 minutes of medical discussion)).
In April 2023, the AMA-RUC noted that the survey instrument they
used to develop valuation recommendations for the telemedicine E/M
codes did not include the time (when time is used for code selection)
in the new telemedicine E/M services descriptors, or the E/M services
displayed on the reference service list. The AMA-RUC made interim
valuation recommendations and conducted a new survey for September
2023, which included the minimum required times in the code
descriptors, and those minimum times were the same as appear in
existing O/O E/M services code descriptors (CPT codes 99202-99205,
99212-99215); the new survey in September 2023 included code
descriptors and times approved by the CPT Editorial Panel in May 2023.
Also, additional specialties who perform E/M services participated in
the second round of this survey. For CY 2025, the RUC recommended the
following work RVUs: a work RVU of 0.93 for CPT code 9X075, a work RVU
of 1.6 for CPT code 9X076, a work RVU of 2.6 for CPT code 9X077, a work
RVU of 3.50 for CPT code 9X078, a work RVU of 0.70 for CPT code 9X079,
a work RVU of 1.30 for CPT code 9X080, a work RVU of 1.92 for CPT code
9X081, a work RVU of 2.60 for CPT code 9X082, a work RVU of 0.90 for
CPT code 9X083, a work RVU of 1.60 for CPT code 9X084, a work RVU of
2.42 for CPT code 9X085, a work RVU of 3.20 for CPT code 9X086, a work
RVU of 0.65. for CPT code 9X087, a work RVU of 1.20 for CPT code 9X088.
In April 2023, the AMA-RUC Practice Expense Subcommittee approved
the direct practice expense inputs as recommended by the specialty
societies without modification, and CMS received these inputs as
recommendations from the RUC. The specialty societies detailed their
methodology for making some changes to specific clinical activity codes
to adapt those clinical activity codes for telemedicine. The AMA edited
both CA009 and CA013. The AMA revision to CA009 deletes, ``greet
patient, provide gowning''; the AMA revision to CA013 deletes,
``Prepare room, equipment and supplies''. CA009 now reads, ``Ensure
appropriate medical records are available'' and CA013 now reads,
``Prepare patient for the visit (i.e., check audio and/or visual''. The
RUC, using the Practice Expense subcommittee recommendations, also
recommended to CMS that a camera and microphone ``should be considered
typical in the computer contained in the indirect overhead expense.''
This determination is consistent with CMS' longstanding position that
items that are not specifically attributable to the individual services
should not be included for valuation of specific codes.
The AMA-RUC recommended the direct practice expense inputs as
submitted by the AMA-member specialty societies, and as affirmed by the
AMA-RUC Practice Expense Subcommittee. All supply and equipment costs
were zeroed out from the reference services, and as a result, the new
telemedicine E/M codes did not include any supply or equipment costs in
the recommended direct practice expense inputs that the AMA submitted
to CMS. The direct PE inputs removed from the reference services to
create the new telemedicine E/M codes are: CA010 (obtain vital signs),
CA024 (clean room/equipment by clinical staff), SA047 (pack, EM visit),
SM022 sanitizing cloth-wipe (surface, instruments, equipment), EQ189
(otoscope-ophthalmoscope [wall unit]), EF048 (Portable stand-on scale),
and EF023 (table, exam).
Sixteen of the telemedicine E/M codes describe use of either audio-
video or audio-only telecommunications technology to furnish the
individual service. The CPT Editorial Panel finalized eight codes for
synchronous audio-video services (CPT codes 9X075 to 9X082), and eight
codes for synchronous audio-only services (CPT codes 9X083 to 9X0890),
and one code for an asynchronous service (CPT code 9X091). The audio-
video and audio-only code family subsets have parallel codes for new
patients and established patients. Like other E/M codes, these codes
may be reported based on the level of medical decision making (MDM) or
total time on the date of the encounter. For each set of four codes,
there is a code that may be reported for a straightforward, low,
moderate and high level of MDM.
[[Page 61652]]
The CPT Editorial Panel also established new CPT code 9X091
describing a brief virtual check-in encounter that is intended to
evaluate the need for a more extensive visit (that is, a visit
described by one of the office/outpatient E/M codes). The code
descriptor for CPT code 9X091 mirrors existing HCPCS code G2012 (Brief
communication technology-based service, e.g., virtual check-in, by a
physician or other qualified health care professional who can report
evaluation and management services, provided to an established patient,
not originating from a related e/m service provided within the previous
7 days nor leading to an e/m service or procedure within the next 24
hours or soonest available appointment; 5-10 minutes of medical
discussion) and, per the CPT Editorial Panel materials, is intended to
replace that code. As described in CPT Editorial Panel final edits, CPT
code 9X091 does not require the use of audio or video technology and is
expected to be patient-initiated. Furnishing the complete service
described by CPT code 9X091 must involve 5-10 minutes of medical
discussion (and the code descriptor does not include MDM as means of
code selection). CPT code 9X091 should not be reported if it originates
from a related E/M service furnished within the previous 7 days, or, if
the clinical interaction leads to another E/M or procedure within the
next 24 hours or the soonest available appointment. The final CPT
Editorial Panel draft language explains that if the virtual check-in
described by CPT 9X091 leads to an E/M visit in the next 24 hours, and
if that E/M is reported based on time, then the time from the virtual
check-in may be added to the time of the resulting E/M visit to
determine the total time on the date of encounter for the resulting E/
M. The RUC recommended a work RVU of 0.30 for 9X091.
The CPT Editorial Panel also deleted three codes (99441-99443) for
reporting telephone E/M services. We note that CPT codes 99441, 99442,
and 99443, each are assigned provisional status on the Medicare
telehealth services list, and would return to bundled status when the
telehealth flexibilities expire on December 31, 2024. For further
background, we refer readers to our discussions in previous rulemaking,
where CMS explains the rationale for this policy (88 FR 78871-78878).
CMS has a long-standing interpretation of section 1834(m) of the
Act as specifying the circumstances under which Medicare makes payment
for services that would otherwise be furnished in person but are
instead furnished via telecommunications technology. Specifically,
section 1834(m)(2)(A) of the Act expressly requires payment to the
distant site physician or practitioner of an amount equal to the amount
that such physician or practitioner would have been paid had such
service been furnished without the use of a telecommunications system.
This means that we must pay an equal amount for a service furnished
using a ``telecommunications system'' as for a service furnished in
person (without the use of a telecommunications system). In the CY 2019
PFS final rule, we stated that ``[w]e have come to believe that section
1834(m) of the Act does not apply to all kinds of physicians' services
whereby a medical professional interacts with a patient via remote
communication technology. Instead, we believe that section 1834(m) of
the Act applies to a discrete set of physicians' services that
ordinarily involve, and are defined, coded, and paid for as if they
were furnished during an in-person encounter between a patient and a
health care professional'' (83 FR 59483). Under this interpretation,
services that are coded and valued based on the understanding that they
are not ordinarily furnished in person, such as remote monitoring
services and communication technology-based services, are not
considered Medicare telehealth services under section 1834(m) of the
Act and thus not subject to the geographic, site of service, and
practitioner restrictions included therein.
Information provided to CMS from the RUC indicates that CPT codes
9X075-9X090 describe services that would otherwise be furnished in
person, and as such the services described by these codes are subject
to section 1834(m) of the Act. In the summary of the coding changes,
the AMA states that these services are ``patterned after the in-person
office visit codes.'' The draft CPT prefatory language states that
``[t]elemedicine services are used in lieu of an in-person service when
medically appropriate to address the care of the patient and when the
patient and/or family/caregiver agree to this format of care.'' The
draft CPT prefatory language likewise states that when a telemedicine
E/M is billed on the same day as another E/M service ``the elements and
time of these services are summed and reported in aggregate, ensuring
that any overlapping time is only counted once,'' which indicates that
the work of the telemedicine E/M service is identical to the work
associated with an in-person, non-telehealth E/M. The code descriptors
and requirements for billing the codes generally mirror the existing
office/outpatient E/M codes with the exception of the technological
modality used to furnish the service. The audio-video telemedicine E/M
codes have nearly identical recommended work RVUs to parallel office/
outpatient E/M codes. In general, the audio-only telemedicine E/M codes
have lower recommended work RVUs than parallel office/outpatient E/M
codes. The RUC stated that this is because, when surveyed, specialty
societies indicated that ``the audio-video and in-person office visits
require more physician work than the audio-only office visits.''
Table 10 describes the similarities between 16 of 17 telemedicine
E/M codes and the parallel office/outpatient E/M codes. The table shows
that except for the element of ``modality'' (that is, audio-video or
audio-only), the service elements of the new telemedicine E/M code
family are no different than the O/O E/M codes (for each enumerated row
1 through 16 the columns display the analogous elements). When
comparing code descriptors, as described at the start of this section,
the only difference (as represented in Table 10 when comparing the
elements of E/M services represented by columns C, D, E, and F) is that
these new telemedicine E/M code descriptors lead with the phrase
``synchronous audio-video'' or ``synchronous audio only'' before
describing the visit in full exactly as the existing office/outpatient
E/M visit codes describe a visit in the long descriptor of the
analogous service.
BILLING CODE P
[[Page 61653]]
[GRAPHIC] [TIFF OMITTED] TP31JY24.014
BILLING CODE C
There are services already describing audio-video and audio-only
telemedicine E/M codes on the Medicare telehealth services list--the
office/outpatient E/M code set--that can be furnished via synchronous
two-way, audio/video communication technology generally and via audio-
only communication technology under certain circumstances to furnish
Medicare telehealth services in the patient's home for the purpose of
diagnosis and treatment of a mental health disorder or SUD.
Additionally, as stated above, section 1834(m)(2)(A) of the Act
requires us to pay an equal amount for a service furnished using a
``telecommunications system'' as for a service furnished in person
(without the use of a telecommunications system). Were we to accept the
AMA's recommendations and add the telemedicine E/M codes to the
Medicare telehealth services list, we would need to establish RVUs for
the telemedicine E/M codes to equal the corresponding non-telehealth
services to satisfy the requirements for payment under section
1834(m)(2)(A) of the Act.
We do not believe that there is a programmatic need to recognize
the audio/video and audio-only telemedicine E/M codes for payment under
Medicare. We are proposing to assign CPT codes 9X075-9X090 a Procedure
Status indicator of ``I'', meaning that there is a more specific code
that should be used for purposes of Medicare, which in this case would
be the existing office/outpatient E/M codes currently on the Medicare
telehealth services list when billed with the appropriate POS code to
identify the location of the beneficiary and, when applicable, the
appropriate modifier to identify the service as being furnished via
audio-only communication technology.
Section 4113 of the Consolidated Appropriations Act (CAA), 2023
extended the availability of Medicare telehealth services to
beneficiaries regardless of geographic location or site of service by
temporarily removing such statutory restrictions under section 1834(m)
of the Act until the end of 2024. Under the current statute, the
geographic location and site of service restrictions on Medicare
telehealth services will once again take effect for services furnished
beginning January 1, 2025. Although there are some important
exceptions, including for behavioral health services and ESRD-related
clinical assessments, most
[[Page 61654]]
Medicare telehealth services will once again, in general, be available
only to beneficiaries in rural areas and only when the patient is
located in certain types of medical settings. As previously discussed,
the introduction of new CPT coding to describe telemedicine E/M
services does not change our authority to pay for visits furnished
through interactive communications technology in accordance with
section 1834(m) of the Act. We recognize that there are significant
concerns about maintaining access to care through the use of Medicare
telehealth services with the expiration of the statutory flexibilities
that were successively extended by legislation following the PHE for
COVID-19. We understand that millions of Medicare beneficiaries have
utilized interactive communications technology for visits with
practitioners for a broad range of health care needs for almost 5
years. We are seeking comment from interested parties on our
understanding of the applicability of section 1834(m) of the Act to the
new telemedicine E/M codes, and how we might potentially mitigate
negative impact from the expiring telehealth flexibilities, preserve
some access, and assess the magnitude of potential reductions in access
and utilization. On the latter point, we note that we have developed
proposed PFS payment rates for CY 2025, including the statutory budget
neutrality adjustment, based on the presumption that changes in
telehealth utilization will not affect overall service utilization. We
also note that historically we have not considered changes in the
Medicare telehealth policies to result in significant impact on
utilization such that a budget neutrality adjustment would be
warranted. However, we are unsure of the continuing validity of that
premise under the current circumstances where patients have grown
accustomed over several years to broad access to services via
telehealth. We are seeking comment on what impact, if any, the
expiration of the current flexibilities would be expected to have on
overall service utilization for CY 2025. We refer readers to section
IV.B. of this proposed rule for our discussion of budget neutrality
adjustments.
Given the similarity between CPT code 9X091 and HCPCS code G2012,
we are proposing to accept the RUC-recommended values for CPT code
9X091, and we are proposing to delete HCPCS code G2012. For CPT code
9X091, we propose to accept the RUC- recommended work RVU of 0.30, and
are proposing the RUC-recommended direct PE inputs. We note that our
proposal does maintain the same direct PE inputs, which the RUC
recommendations leave unchanged from the current G2012 in total amount,
and allocate the same 3 minutes of time to the same level of staff
(Clinical Staff code L037D, RN/LPN/MTA). We believe that the coding and
payment recommendations for CPT code 9X091, submitted to CMS by the AMA
RUC, accurately reflect the resources associated with this service and
believe that maintaining separate coding for purposes of Medicare
payment could create confusion. We note that, similar to our current
policy for payment of HCPCS code G2012, CPT code 9X091 would be
considered a communication technology-based service that is not subject
to the requirements in section 1834(m) of the Act applicable to
Medicare telehealth services.
(19) Genetic Counseling Services (CPT Code 9X100)
In September 2023, the CPT Editorial Panel deleted CPT code 96040
(Medical genetics and genetic counseling services, each 30 minutes
face-to-face with patient/family) and created CPT code 9X100 (Medical
genetics and genetic counseling services, each 30 minutes of total time
provided by the genetic counselor on the date of the encounter) for
medical genetics and genetic counseling services to be provided by the
genetic counselor. Prior to its deletion, CPT code 96040 would only be
reported by genetic counselors for genetic counseling services, though
genetic counselors are not among the practitioners who can bill
Medicare directly for their professional services. As we stated in the
CY 2012 PFS final rule (76 FR 73096 through 73097), physicians and NPPs
who may independently bill Medicare for their services and who are
counseling individuals would generally report office or other
outpatient E/M CPT codes for office visits that involve significant
counseling, including genetic counseling; therefore CPT code 96040 was
considered bundled into O/O E/M visits.
For CPT code 9X100, we are proposing the RUC-recommended direct PE
inputs. We note that the code descriptor now specifies that the service
is provided by a genetic counselor, therefore we considered assigning
Procedure Status ``X'' to CPT code 9X100. Because the PE RVUs would not
display for the code with that assignment and that may impact access to
the service with other payors, we are instead proposing bundled status
(Procedure Status ``B'') for CPT code 9X100 to maintain the status of
predecessor CPT code 96040, and we are seeking feedback from interested
parties regarding the appropriate procedure status for this code. CPT
guidelines for CPT code 9X100 state that a physician or other qualified
healthcare professional (QHP) who may report evaluation and management
services would not be able to report CPT code 9X100. Instead, these
physicians and QHPs would use the appropriate evaluation and management
code.
(20) COVID Immunization Administration (CPT Code 90480)
On August 14, 2023, new CPT codes were created to consolidate over
50 previously implemented codes and streamline the reporting of
immunizations for the novel coronavirus (SARS-CoV-2, also known as
COVID-19). The CPT Editorial Panel approved the addition of a single
administration code (CPT code 90480) for administration of new and
existing COVID-19 vaccine products. The RUC reviewed the specialty
societies' recommendations for this code at the September 2023 RUC
meeting.
We are proposing the RUC-recommended work RVU of 0.25 for CPT code
90480 (Immunization administration by intramuscular injection of severe
acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus
disease [COVID-19]) vaccine, single dose). We are also proposing the
RUC-recommended direct PE inputs for CPT code 90480 without refinement.
(21) Optical Coherence Tomography (CPT Codes 92132, 92133, 92134, and
9X059)
At the February 2023 CPT Editorial Panel meeting, CPT code 9X059
(Computerized ophthalmic diagnostic imaging (eg, optical coherence
tomography [OCT]), posterior segment, with interpretation and report,
unilateral or bilateral; retina including OCT angiography) was created
in response to new technology that allows imaging of the retina using
optical coherence tomography (OCT) with and without non-dye OCT
angiography (OCT-A). This code family also includes CPT code 92132
(Computerized ophthalmic diagnostic imaging (eg, optical coherence
tomography [OCT]), anterior segment, with interpretation and report,
unilateral or bilateral), CPT code 92133 (Computerized ophthalmic
diagnostic imaging (eg, optical coherence tomography [OCT]), posterior
segment, with interpretation and report, unilateral or bilateral; optic
nerve), and CPT code 92134 (Computerized
[[Page 61655]]
ophthalmic diagnostic imaging (eg, optical coherence tomography [OCT]),
posterior segment, with interpretation and report, unilateral or
bilateral; retina). These codes were reviewed at the April 2023 RUC
meeting. The RUC determined the survey results were inaccurate due to
underestimation of time, so the entire code family was re-surveyed and
reviewed at the September 2023 RUC meeting.
We are proposing the RUC-recommended work RVUs for all codes within
the Optical Coherence Tomography code family. We are proposing a work
RVU of 0.29 for CPT code 92132, a work RVU of 0.31 for CPT code 92133,
a work RVU of 0.32 for CPT code 92134, and a work RVU of 0.64 for CPT
code 9X059. We are also proposing the RUC-recommended direct PE inputs
for all four codes in the family.
(22) Transcranial Doppler Studies (CPT Codes 93886, 93888, 93892,
93893, 93X94, 93X95, 93X96, and 93890)
The RUC's Relativity Assessment Workgroup (RAW) requested action
plans in September 2022 to determine if specific code bundling
solutions should occur for CPT codes 93890/93886, 93890/93892, 93892/
93886, and 93892/93890. The RAW referred this issue to the CPT
Editorial Panel which created three new add-on codes to report when
additional studies are performed on the same date of services as a
complete transcranial Doppler study. The RUC reviewed these three new
add-on codes, as well as CPT codes 93886, 93888, 93892 and 93893 for
the September 2023 RUC meeting.
We are proposing the RUC-recommended work RVU for all seven codes
in the Transcranial Doppler Studies code family. We are proposing a
work RVU of 0.90 for CPT code 93886 (Transcranial Doppler study of the
intracranial arteries; complete study), a work RVU of 0.73 for CPT code
93888 (Transcranial Doppler study of the intracranial arteries; limited
study), a work RVU of 1.15 for CPT code 93892 (Transcranial Doppler
study of the intracranial arteries; emboli detection without
intravenous microbubble injection), a work RVU of 1.15 for CPT code
93893 (Transcranial Doppler study of the intracranial arteries; venous-
arterial shunt detection with intravenous microbubble injection), a
work RVU of 0.81 for CPT code 93X94 (Vasoreactivity study performed
with transcranial Doppler study of intracranial arteries, complete), a
work RVU of 0.73 for CPT code 93X95 (Emboli detection without
intravenous microbubble injection performed with transcranial Doppler
study of intracranial arteries, complete), and a work RVU of 0.85 for
CPT code 93X96 (Venous-arterial shunt detection with intravenous
microbubble injection performed with transcranial Doppler study of
intracranial arteries, complete). We are also proposing the direct PE
inputs as recommended by the RUC for all seven codes in this family.
We note that the billing instructions for this code family specify
that the three new add-on codes should be used in conjunction with CPT
code 93886, and that CPT code 93888 should not be used in conjunction
with CPT codes 93886, 93892, 93893, 93X94, 93X95, and 93X96. However,
we believe that it would be beneficial for the CPT Editorial Panel to
state more explicitly that CPT code 93X95 should not be used in
conjunction with CPT code 93892 and that CPT code 93X96 should not be
used in conjunction with CPT code 93893. The work performed in the add-
on codes would be duplicative of the base codes in these situations and
result in unnecessary overbilling of services.
(23) RSV Monoclonal Antibody Administration (CPT Codes 96380 and 96381)
At the September 2023 CPT meeting, the CPT Editorial Panel created
two codes to report passive administration of respiratory syncytial
virus, monoclonal antibody, seasonal dose, with and without counseling.
CPT codes 96380 and 96381 were reviewed the following week at the
September 2023 RUC meeting and the RUC submitted recommendations to
CMS.
We are proposing the RUC-recommended work RVU of 0.24 for CPT code
96380 (Administration of respiratory syncytial virus, monoclonal
antibody, seasonal dose by intramuscular injection, with counseling by
physician or other qualified health care professional) and the RUC-
recommended work RVU of 0.17 for CPT code 96381 (Administration of
respiratory syncytial virus, monoclonal antibody, seasonal dose by
intramuscular injection). We understand that these are interim work
recommendations from the RUC, and that the RUC intends to conduct a
more complete review at a future RUC meeting which we would then
consider in future rulemaking. We are also proposing the direct PE
inputs as recommended by the RUC for both codes.
(24) Hyperthermic Intraperitoneal Chemotherapy (CPT Codes 96547 and
96548)
In September 2022, the CPT Editorial Panel created two time-based
add-on Category I codes, CPT code 96547 (Intraoperative hyperthermic
intraperitoneal chemotherapy (HIPEC) procedure, including separate
incision(s) and closure, when performed; first 60 minutes (List
separately in addition to code for primary procedure)) and CPT code
96548 (Intraoperative hyperthermic intraperitoneal chemotherapy (HIPEC)
procedure, including separate incision(s) and closure, when performed;
each additional 30 minutes (List separately in addition to code for
primary procedure)), to report HIPEC procedures for 2024. At the
January 2023 RUC meeting, the RUC reached the conclusion that the
survey data was flawed due to a lack of work definition and guidelines,
and the RUC recommended contractor pricing for CPT codes 96547 and
96548 for CY 2024 with further clarification from the CPT editorial
panel. CMS proposed and finalized contractor pricing for CPT codes
96547 and 96548 for 2024. At the May 2023 CPT Editorial Panel meeting,
new guidelines and descriptions of work activities were approved and
the codes were resurveyed for the September 2023 RUC meeting with
recommendations for national pricing.
We are proposing the RUC-recommended work RVU of 6.53 for CPT code
96547 and the RUC-recommended work RVU of 3.00 for CPT code 96548. The
RUC did not recommend, and we are not proposing, any direct PE inputs
for the Hyperthermic Intraperitoneal Chemotherapy codes (CPT codes
96547 and 96548).
(25) Laser Treatment--Skin (CPT Codes 96920, 96921, and 96922)
In April 2022, the RUC referred CPT codes 96920 (Excimer laser
treatment for psoriasis; total area less than 250 sq cm), 96921
(Excimer laser treatment for psoriasis; 250 sq cm to 500 sq cm), and
96922 (Excimer laser treatment for psoriasis; over 500 sq cm) to the
CPT Editorial Panel to capture expanded indications beyond what was
currently noted in the codes' descriptions to include laser treatment
for other inflammatory skin disorders such as vitiligo, atopic
dermatitis, and alopecia areata, which could result in changed
physician work based on the expanded indications. The coding change
application was subsequently withdrawn from the September 2023 CPT
Editorial meeting when it was determined that existing literature was
insufficient and did not support expanded indications at that time.
Therefore, these CPT codes were re-surveyed and reviewed at the April
[[Page 61656]]
2023 RUC meeting without any revisions to their code descriptors.
We disagree with the RUC-recommended work RVUs for CPT codes 96920,
96921, and 96922 of 1.00, 1.07, and 1.32, respectively. The RUC noted
that there have been multiple reviews of these CPT codes, and the
valuation of the codes is currently based on the original valuation
over two decades ago in 2002 where the physician time values were lower
than the current times. A subsequent review in 2012 adopted new survey
times while maintaining the work RVUs from 2002 for CPT codes 96920 and
96922. The RUC noted that, for both CPT code 96920 and 96922 with the
largest treatment area, the total times have not changed since first
implemented more than 20 years ago. While we understand that the
physician times have fluctuated over the course of several years and
several reviews, yet the work RVUs have remained mostly constant as
shown in Table 11, this was not addressed in the 2012 recommendations,
and we believe that our operating assumption regarding the validity of
the existing values as a point of comparison is critical to the
integrity of the relative value system as currently constructed. The
work times currently associated with codes play a very important role
in PFS ratesetting, both as points of comparison in establishing work
RVUs and in the allocation of indirect PE RVUs by specialty. If we were
to operate under the assumption that previously recommended work times
had been routinely over or underestimated, this would undermine the
relativity of the work RVUs on the PFS in general, in light of the fact
that codes are often valued based on comparisons to other codes with
similar work times. We also 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.
[GRAPHIC] [TIFF OMITTED] TP31JY24.015
For CPT code 96920, we are proposing a work RVU of 0.83 based on a
crosswalk to CPT code 11104 (Punch biopsy of skin (including simple
closure, when performed); single lesion), which has the same 10 minutes
of intraservice time and 23 minutes of total time as CPT code 96920. We
note that of the 15 other 000-day global codes with a total time of 20
to 25 minutes, only four codes fall above the RUC-recommended work RVU
of 1.00. While we understand that commenters will dispute the validity
of the current time values, we note that the 2002 intraservice time was
17 minutes, which yields an intraservice time ratio between the 2002
intraservice time and the recommended intraservice time of 10 minutes
of 0.68 work RVUs ((10 minutes/17 minutes) * 1.15). We note our
proposed work RVU of 0.83 maintains the intensity associated with the
2002 review of CPT code 96920, which we believe to be more appropriate
than the significant increase in intensity that results from the RUC-
recommended work RVU of 1.00 which nearly doubles the current intensity
of the code. We have no evidence to indicate that the intensity of CPT
code 96920 is increasing to this degree given how the surveyed work
time is substantially decreasing.
For CPT code 96921, we are proposing a work RVU of 0.90 based on a
total time ratio to CPT code 96920 ((25/23) * 0.83) and a crosswalk to
CPT code 11301 (Shaving of epidermal or dermal lesion, single lesion,
trunk, arms or legs; lesion diameter 0.6 to 1.0 cm), which has 3
additional minutes of intraservice time and 1 additional minute of
total time compared to CPT code 96921. We also note that our proposed
work RVU of 0.90 for CPT code 96921 maintains the RUC-recommended
incremental difference between CPT codes 96920 and 96921 of 0.07 work
RVUs. Like CPT code 96920, we understand that commenters will dispute
the validity of the current time values, but we note that the 2002
intraservice time was 20 minutes, which yields an intraservice time
ratio between the 2002 intraservice time and the recommended
intraservice time of 12 minutes of 0.70 work RVUs ((12 minutes/20
minutes) * 1.17). Like CPT code 96920, we note that proposed work RVU
of 0.90 for CPT code 96921 maintains the intensity associated with the
2002 review of CPT code 96921, which we believe is more appropriate
than the intensity increase that results from the RUC-recommended work
RVU of 1.07 which again nearly doubles the current intensity of the
code.
For CPT code 96922, we are proposing a work RVU of 1.15 based on
the RUC-recommended incremental difference between CPT codes 96921 and
96922 of 0.25 work RVUs. Like CPT code 96920 and 96921, we understand
that commenters will dispute the validity of the current time values,
but we note that the 2002 intraservice time was 30 minutes, which
yields an intraservice time ratio between the 2002 intraservice time
and the recommended intraservice time of 18 minutes of 1.26 work RVUs
((18 minutes/30 minutes) * 2.10). We note that the RUC recommended CPT
code 96922 as having the lowest intensity of the three codes in this
family and that our proposed work RVU of 1.15 maintains in relationship
to the other codes.
For the direct PE inputs, we are proposing to refine the clinical
staff
[[Page 61657]]
time for the CA024 activity ``Clean room/equipment by clinical staff''
to the standard of 3 minutes for CPT codes 96920, 96921, and 96922. We
note that 3 minutes is the current CA024 time for these three CPT
codes. A rationale for extending clinical staff beyond the standard 3
minutes for the CA024 activity was absent from the PE Summary of
Recommendations, therefore we believe the current and standard 3
minutes is more appropriate than the RUC-recommended 5 minutes. We are
also proposing equipment times of 36, 38, and 44 minutes for the power
table (EF031) and exam light (EQ168) equipment for CPT codes 96920,
96921, and 96922, respectively, to account for the proposed refinement
for CA024 to the standard 3 minutes.
We also disagree with the RUC-recommended creation of new supply
items for the excimer laser and are proposing to re-include the
equipment time for the excimer laser (EQ161) using the current
methodology where its cost is accounted for in the equipment of these
CPT codes' direct PE. The RUC submitted recommendations to change this
equipment item to new supply items to account for the per-use cost to
rent the equipment, stating that the business model has changed from
the standard equipment ownership that CMS recognizes using standardized
equipment formulas to a per-use rental or subscription model. While we
understand that there may have been a change in business model, we do
not believe a rental, subscription, or per-use fee of an equipment item
that is still available to be purchased and is already accounted for
with our equipment methodology is appropriate, especially given its
implications for direct PE costs for these CPT codes. Therefore, we are
proposing reincorporating equipment times of 36, 38, and 44 minutes for
the EQ161 equipment for CPT codes 96920, 96921, and 96922,
respectively, based on the refined service period clinical labor times.
We are proposing to remove the three pay-per-use excimer lasers listed
as supplies and recommended by the RUC for these three codes.
We have repeatedly stated in past rulemaking that rental and
licensing fees are typically considered forms of indirect PE under our
methodology. In the CY 2020 PFS final rule, we omitted the inclusion of
several invoices for the monthly rental price of a PET infusion cart
(ER109), and only accounted for the four purchase invoices for the
equipment. We noted as well for future reference that although we
appreciated the submission of the rental invoices, we were unable to
use invoices for a monthly rental fee to determine the typical purchase
price for equipment. We believe that invoices for a monthly rental fee
would not be representative of the purchase price for equipment, in the
same fashion that the rental fee for a car differs from its purchase
price (84 FR 62771). Similarly, while we appreciate the submission of
per-use, rental, and partnership invoices for the excimer laser, we
believe that the excimer laser is appropriately and adequately
accounted for in the equipment formula, and note that EQ161 has a very
high cost per minute of $0.5895/minute. Compared to the nearly 700
other equipment items in our database, only 55 equipment items have
higher costs per minute (based on our standardized formula which
accounts for years of useful life, utilization rate, purchase price,
and minutes per year of use, discussed in detail in section II.B. of
this proposed rule, Determination of PE RVUs) and only 53 equipment
items have higher purchase prices than the excimer laser at $151,200.
We do not believe that CPT codes 96920 through 96922 should be valued
based on a significantly more expensive pay-per-use rental version of
the excimer laser when the same treatment is cheaper and available as a
purchasable form of equipment.
Therefore, we are seeking comment on the difference in direct PE
costs between the purchase and per-use rental of the laser. We note
that using the equipment cost per minute formula, discussed in detail
of section II.B. of this proposed rule, Determination of PE RVUs,
yields direct PE costs of about $21.22, $22.40, and $25.94 for CPT
codes 96920, 96921, 96922, respectively. Alternatively, the new supply
items for the per-use fee of the laser yielded direct PE costs of $80,
$83, and $100 for CPT codes 96920, 96921, 96922, respectively. These
direct PE disparities represent a 277 percent, 270.5 percent, and 285.5
percent increase for CPT codes 96920, 96921, 96922, respectively. Given
this, we are interested in feedback from interested parties on the
payment disparity between this equipment as a per-use or rental versus
how we currently account for the purchase of equipment using the
standard equipment formula, as we understand that both manufacturers
and physicians may be inclined to shift to a per-use or rental business
models to limit overhead for purchase and maintenance of expensive
equipment.
(26) Physical Medicine and Rehabilitation (CPT Codes 97012, 97014,
97016, 97018, 97022, 97032, 97033, 97034, 97035, 97110, 97112, 97113,
97116, 97140, 97530, 97533, 97535, 97537, and 97542 and HCPCS Code
G0283)
The RUC's Health Care Professionals Advisory Committee (HCPAC)
previously reviewed 19 physical medicine and rehabilitation codes in
February 2017. In the CY 2024 PFS proposed rule, CMS received public
nominations on these same 19 therapy codes as potentially misvalued (88
FR 78851-78852). An interested party asserted that the direct PE
clinical labor minutes reflected inappropriate multiple procedure
payment reductions (MPPR), which were duplicative of the CMS MPPR
policy implemented in CMS' claims processing systems. CMS reviewed the
clinical labor time entries for these 19 therapy codes and concluded
that a payment reduction should not have been applied in some instances
to the 19 nominated therapy codes' clinical labor time entries since
the payment valuation reduction would be duplicative of the MPPR
applied during claims processing. CMS indicated that the valuation of
these services would benefit from additional review through the RUC's
HCPAC valuation process; they were therefore reviewed by the HCPAC for
PE only, with no work review, at the January 2024 RUC meeting for
inclusion in the CY 2025 PFS proposed rule.
The HCPAC's direct PE recommendations were based on the typical
number of services reported per session, which was 3.5 units according
to CMS data, to ensure that there was no duplication in the standard
inputs for preservice and postservice time. To account for the MPPR,
the HCPAC determined that 3.5 codes are billed per session, with the
first paid at 100% and the second and subsequent units paid at half and
so forth for PE (for example, 1.00 + 0.5 + 0.5 + 0.25 = 2.25). This
resulted in the HCPAC recommending that many of the standard clinical
labor times be divided by 2.25 to account for the MPPR, such as taking
the standard 3 minutes for greeting and gowning the patient and
dividing it by 2.25 to arrive at the recommended time of 1.33 minutes
(1.33 + 0.67 + 0.67 + 0.34 = 3 minutes). In most cases, the HCPAC
recommended using the standard equipment time formula aside from a few
exceptions such as the use of the whirlpool in CPT code 97022 which
would require additional time for the cleaning of the equipment.
[[Page 61658]]
Following the January 2024 RUC meeting, representatives from the
American Physical Therapy Association (APTA) and the American
Occupational Therapy Association (AOTA) met with CMS to express concern
with the HCPAC's recommended direct PE inputs for this family of codes.
Representatives from these trade associations stated that the HCPAC had
inappropriately recommended too few equipment minutes for these
procedures. These interested parties requested utilizing an alternate
equipment time formula for the 19 reviewed therapy codes based on
adding together the intraservice work time together with the clinical
labor for the preservice and postservice portion of the service period.
For 17 of the 19 reviewed therapy codes, this alternate equipment time
formula would result in an increase over the HCPAC's equipment time
recommendations. Table 12 lists the direct PE costs of each HCPCS code
under their current pricing, under the HCPAC recommendations, and the
alternate APTA and AOTA recommendations:
[GRAPHIC] [TIFF OMITTED] TP31JY24.016
After consideration of these recommendations, we are proposing the
direct PE inputs as recommended by the HCPAC for all 19 codes in the
Physical Medicine and Rehabilitation code family. We believe that the
HCPAC's equipment time recommendations better maintain relativity with
the rest of the fee schedule through primarily using standard equipment
time formulas, along with limited exceptions for additional equipment
time in cases where more time for equipment cleaning or patient
positioning would be typical. We also believe that the alternate
equipment time formula recommended by APTA and AOTA leads to
inconsistent equipment times for many of these procedures, such as
recommending 23.98 equipment minutes for CPT code 97110 which is a
timed code billed in 15-minute increments. Although we agree that some
additional equipment time beyond the timed 15 minutes would be typical
for setup and cleaning, 9 additional minutes for each billing of CPT
code 97110 would not appear to reflect typical equipment usage.
Given the complexity of determining appropriate direct PE inputs
across multiple billings of these therapy codes, and the need to factor
in the MPPR, we believe that this code family may benefit from
additional review, specifically review focused on the subject of
appropriate equipment minutes. The HCPAC review of these codes was
primarily focused on the clinical labor portion of the PE inputs and
the equipment times did not receive the same degree of scrutiny as the
clinical labor. We believe that the HCPAC's recommended direct PE
inputs are the most accurate values based on the current information
that we have available, however this is a topic that may warrant
additional review to ensure that this family of codes is properly
valued.
(27) Acupuncture--Electroacupuncture (CPT Codes 97810, 97811, 97813,
and 97814)
In September 2022, the RUC's Relativity Assessment Workgroup
identified the acupuncture codes with 2020 Medicare utilization over
10,000 where the service was surveyed by one specialty but is now
performed by a different specialty. CPT codes 97810-97814 were selected
and surveyed for the April 2023 RUC meeting.
For CY 2025, we are proposing the RUC-recommended work RVUs for all
four CPT codes. We are proposing a work RVU of 0.61 for CPT code 97810
(Acupuncture, 1 or more needles; without electrical stimulation,
initial 15 minutes of personal one-on-one contact with the patient), a
work RVU of 0.46 for CPT code 97811 (Acupuncture, 1 or more needles;
without electrical stimulation, each additional 15 minutes of personal
one-on-one contact with the patient, with re-insertion of needle(s)
(List separately in addition to code for
[[Page 61659]]
primary procedure)), a work RVU of 0.74 for CPT Code 97813
(Acupuncture, 1 or more needles; with electrical stimulation, initial
15 minutes of personal one-on-one contact with the patient), and a work
RVU of 0.47 for CPT code 97814 (Acupuncture, 1 or more needles; with
electrical stimulation, each additional 15 minutes of personal one-on-
one contact with the patient, with re-insertion of needle(s) (List
separately in addition to code for primary procedure)). We are also
proposing the RUC-recommended direct PE inputs for CPT codes 97810,
97811, 97813 and 97814 without refinement.
(28) Annual Alcohol Screening (HCPCS Codes G0442 and G0443)
In April 2022, the Relativity Assessment Workgroup identified
services with Medicare utilization of 10,000 or more that have
increased by at least 100 percent from 2015 through 2020, including
HCPCS codes G0442 (Annual alcohol misuse screening, 5 to 15 minutes)
and G0443 (Brief face-to-face behavioral counseling for alcohol misuse,
15 minutes). In September 2022, the RUC recommended that these services
be surveyed for April 2023 after CMS published the revised code
descriptor for HCPCS code G0442 in the CY 2023 PFS final rule (87 FR
69523).
We are proposing the RUC-recommended work RVU of 0.18 for HCPCS
code G0442 (Annual alcohol misuse screening, 5 to 15 minutes). We are
also proposing the RUC-recommended work RVU of 0.60 for HCPCS code
G0443 (Brief face-to-face behavioral counseling for alcohol misuse, 15
minutes).
The RUC recommended an increase in the work RVU for HCPCS code
G0443 from 0.45 to 0.60 which we believe is warranted based on time and
intensity of the service in preventing alcohol misuse. In valuing this
code, the time and work valuation is for separate and distinct services
from same-day E/M services since HCPCS codes G0442 and G0443 are
typically billed with an annual wellness visit (AWV) or office visit.
We believe that the codes in the adjacent Behavioral Counseling &
Therapy family, which includes HCPCS codes G0445 (High intensity
behavioral counseling to prevent sexually transmitted infection; face-
to-face, individual, includes: education, skills training and guidance
on how to change sexual behavior; performed semi-annually, 30 minutes),
G0446 (Annual, face-to-face intensive behavioral therapy for
cardiovascular disease, individual, 15 minutes), and G0447 (Face-to-
face behavioral counseling for obesity, 15 minutes), may be undervalued
as their respective intensities may be lower than what is warranted for
these services. We believe that the intensity for these G-codes may be
more in line with the intensity of HCPCS code G0443 which we noted had
an increase in intensity as recommended by the RUC. As such, we believe
that the Behavioral Counseling & Therapy codes may benefit from
additional review in the future to recognize the intensity of these
services.
We are proposing to maintain the current 15 minutes of clinical
labor time for the CA021 ``Perform procedure/service--NOT directly
related to physician work time'' activity for HCPCS code G0442. This
clinical labor activity is specifically noted as not corresponding to
the surveyed work time of 5 minutes, and we do not believe that it
would be typical for the clinical staff to administer the
questionnaire, clarify questions as needed, and record the answers in
the patient's electronic medical record in the RUC-recommended 5
minutes. We believe that the current 15 minutes of clinical labor time
would be more typical to ensure the accuracy of this screening
procedure. We are also proposing to maintain 15 minutes of
corresponding equipment time for the EF023 exam table as a result of
our proposed clinical labor time refinement. We are proposing the RUC-
recommended direct PE inputs for HCPCS code G0443 without refinement.
We thank the RUC for their review of this code family and for
highlighting an important consideration specifically for services that
fall under the Medicare preventive services benefit. We are now
considering how best to implement and maintain payment for preventive
services and may develop new payment policies in future rulemaking to
address this issue more comprehensively to ensure consistent access to
these services. We considered the recommended PE inputs for this code
family, as well as for the Annual Depression Screening (HCPCS code
G0444) and Behavioral Counseling & Therapy services (HCPCS codes G0445,
G0446, and G0447) within this context, as noted below.
(29) Annual Depression Screening (HCPCS Code G0444)
In 2012, HCPCS code G0444 (Annual depression screening, 5 to 15
minutes) was added to the PFS (77 FR 68955 and 68956) to report annual
depression screening for adults in primary care settings that have
staff-assisted depression care supports in place to assure accurate
diagnosis, treatment and follow up. In April 2022, the Relativity
Assessment Workgroup identified this service with Medicare utilization
of 10,000 or more that have increased by at least 100 percent from 2015
through 2020. In September 2022, the RUC recommended that this service
be surveyed for April 2023 after CMS published the revised code
descriptor in the CY 2023 PFS final rule (87 FR 69523).
We are proposing the RUC-recommended work RVU of 0.18 for HCPCS
code G0444.
We are proposing to maintain the current 15 minutes of clinical
labor time for the CA021 ``Perform procedure/service--NOT directly
related to physician work time'' activity for HCPCS code G0444. This
clinical labor activity is specifically noted as not corresponding to
the surveyed work time of 5 minutes, and we do not believe that it
would be typical for the clinical staff to administer the
questionnaire, clarify questions as needed, and record the answers in
the patient's electronic medical record in the RUC-recommended 5
minutes. We believe that the current 15 minutes of clinical labor time
would be more typical to ensure the accuracy of this screening
procedure. We are also proposing to maintain 15 minutes of
corresponding equipment time for the EF023 exam table as a result of
our proposed clinical labor time refinement.
(30) Behavioral Counseling & Therapy (HCPCS Codes G0445, G0446, and
G0447)
CMS created HCPCS codes G0445 (High intensity behavioral counseling
to prevent sexually transmitted infection; face-to-face, individual,
includes education, skills training and guidance on how to change
sexual behavior; performed semi-annually, 30 minutes), G0446 (Annual,
face-to-face intensive behavioral therapy for cardiovascular disease,
individual, 15 minutes), and G0447 (Face-to-face behavioral counseling
for obesity, 15 minutes) effective with the 2012 Medicare PFS (77 FR
68892). HCPCS codes G0445-G0447 were identified to be reviewed at the
April 2023 RUC meeting because they were services with Medicare
utilization of 10,000 or more that had increased by at least 100% from
2015 through 2020.
The specialty societies surveyed HCPCS codes G0445-G0447 for the
April 2023 RUC meeting but did not obtain the required number of survey
responses. After the resurvey, which occurred after the April 2023 RUC
meeting, the specialty societies were again unable to achieve the
required minimum number of survey responses
[[Page 61660]]
for any of the codes in this family for the September 2023 RUC meeting.
The RUC reviewed HCPCS codes G0445-G0447 at the September 2023 RUC
meeting. Given the insufficient number of survey responses and
considering that these are CMS-created time-based codes, the RUC
determined it would be most appropriate to maintain the current work
values and flagged these codes for review in 3 years. We are proposing
the RUC-recommended work RVU of 0.45 for each of these three HCPCS
codes, G0445-G0447.
We are not proposing the RUC-recommended direct PE inputs for these
codes because of the insufficient number of survey responses, and
further, we do not agree with some of the RUC's refinements to the
direct PE inputs for this service. We are not proposing the RUC-
recommended direct PE inputs for G0445, G0446, and G0447, which include
the SK062 patient education booklet being eliminated in favor of the
SK057 paper, laser printing (each sheet) in the amount of 10 sheets and
the equipment minutes being modified to equal the sum of clinical staff
time plus the physician/QHP time as reflected by the survey median. We
do not agree that these changes are substantiated given the
insufficient number of survey responses and we are proposing to
maintain the current values for each of these direct PE inputs.
We are proposing the RUC recommended refinements to clinical staff
time for HCPCS code G0445. We are proposing to move two minutes from
CA021 Perform procedure/service--NOT directly related to physician work
time to CA035 Review home care instructions, coordinate visits/
prescriptions. We agree with the RUC that this more accurately reflects
the clinical work involved in arranging follow-up and/or referrals with
clinical and community resources and providing educational materials.
Currently, for HCPCS code G0445, PE includes a whip mixer (EP086) and
biohazard hood (EP016) among the equipment assigned to the code. We are
also proposing the RUC recommendations to eliminate both of these
pieces of equipment from the PE for HCPCS code G0445.
We note that the Behavioral Counseling & Therapy code family (HCPCS
codes G0445-G0447) should be reviewed in the future by the RUC and we
anticipate the recommendations that will come from the review for this
family.
(31) Autologous Platelet Rich Plasma (HCPCS Code G0465)
HCPCS code G0465 (Autologous platelet rich plasma (prp) or other
blood-derived product for diabetic chronic wounds/ulcers, using an fda-
cleared device for this indication, (includes as applicable
administration, dressings, phlebotomy, centrifugation or mixing, and
all other preparatory procedures, per treatment)) was created for CY
2022 (retroactively dated back to the effective date of the policy,
April 13, 2021) and assigned contractor pricing (NCD 270.3, CR 12403).
Following the publication of the CY 2023 PFS proposed rule, we
received two comments on the pricing of HCPCS code G0465, and the 3C
patch system supply which is topically applied for the management of
exuding cutaneous wounds, such as leg ulcers, pressure ulcers, and
diabetic ulcers and mechanically or surgically debrided wounds (87 FR
69420). One commenter submitted invoices associated with the pricing of
the 3C patch system (SD343) supply for which we established a price of
$625.00 in the CY 2021 PFS final rule (85 FR 84498). The commenter
requested that CMS update its supply database based on invoices
submitted for SD343 to reflect an updated price of $750.00 per unit.
The commenter also requested national pricing for HCPCS code G0465,
expressing concern that insufficient payment disproportionately impacts
vulnerable populations. The commenter requested a payment rate of
$1,408.90 for HCPCS G0465 in the office setting, stating that this rate
would appropriately account for the purchase of the 3C patch, as well
as the other related costs and supply inputs required for point of care
creation and administration.
In response, we stated in the CY 2023 PFS final rule that we did
not have enough information to establish national pricing at this time
for HCPCS code G0465 (87 FR 69420). We stated that we would consider
the commenters' feedback for future rulemaking while maintaining
contractor pricing for CY 2023, which would allow for more flexibility
for contractors to establish appropriate pricing using available
information. We appreciated the invoice submission with additional
pricing information for the SD343 supply and we updated our supply
database for supply code SD343 at a price of $678.57 based on an
average of the submitted invoices.
Since the publication of the CY 2023 PFS final rule, interested
parties have continued to request national pricing for HCPCS code G0465
due to their perception of inconsistent and insufficient payment for
this service by the MACs. CMS has asked the interested parties to
engage with the MACs to establish adequate payment for HCPCS code
G0465. The interested parties have continued to state that most MACs
have not established consistent payment rates and the rates are
heterogeneous; some are significantly below the cost of performing this
service, leading to an unpredictable process and inadequate rates,
creating barriers to access this service.
Due to these concerns, we are therefore proposing to establish
national pricing for HCPCS code G0465 for CY 2025. We are proposing to
value HCPCS code G0465 using a crosswalk to CPT code 15271 (Application
of skin substitute graft to trunk, arms, legs, total wound surface area
up to 100 sq cm; first 25 sq cm or less wound surface area), drawing
from a selection of relevant studies.17 18 19 20 We are
proposing a work RVU of 1.50 for HCPCS code G0465 based on the
crosswalk to CPT code 15271 because wound surface area sizes in current
literature appear to be less than 100 sq cm for patients with diabetes
and/or chronic ulcers. We are also proposing to use the direct PE
inputs included with CPT code 15271 for valuing HCPCS code G0465, with
the additional inclusion of the 3C patch system (SD343) supply that we
priced in CY 2023. We note that the payment includes debridement, which
may involve a wound reaching the bone. Therefore, debridement may not
be billed separately. In addition, we are currently seeking comments on
other available crosswalks from the broader medical community. For
example, CPT code 15277 (Application of skin substitute graft to face,
scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/
or multiple digits, total wound surface area greater than or equal to
100 sq cm; first 100 sq cm wound surface area, or 1% of body area of
infants and children) with a work RVU of 4.00 and CPT code 15273
(Application of skin substitute graft to
[[Page 61661]]
trunk, arms, legs, total wound surface area greater than or equal to
100 sq cm; first 100 sq cm wound surface area, or 1% of body area of
infants and children) with a work RVU of 3.50 could also be viable
crosswalk options. We are soliciting comments regarding our selection
of CPT code 15271 as a crosswalk code, as well as general comments and
available studies regarding the appropriate valuation of HCPCS code
G0465.
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\17\ Gethin, G et al. ``The profile of patients with venous leg
ulcers: A systematic review and global perspective.'' Journal of
tissue viability vol. 30,1 (2021): 78-88. doi:10.1016/
j.jtv.2020.08.003.
\18\ Sheehan, Peter et al. ``Percent change in wound area of
diabetic foot ulcers over a 4-week period is a robust predictor of
complete healing in a 12-week prospective trial.'' Plastic and
reconstructive surgery vol. 117,7 Suppl (2006): 239S-244S.
doi:10.1097/01.prs.0000222891.74489.33.
\19\ Oyibo, S O et al. ``The effects of ulcer size and site,
patient's age, sex and type and duration of diabetes on the outcome
of diabetic foot ulcers.'' Diabetic medicine: a journal of the
British Diabetic Association vol. 18,2 (2001): 133-8. doi:10.1046/
j.1464-5491.2001.00422.x.
\20\ Patry, J[eacute]r[ocirc]me et al. ``Outcomes and prognosis
of diabetic foot ulcers treated by an interdisciplinary team in
Canada.'' International wound journal vol. 18,2 (2021): 134-146.
doi:10.1111/iwj.13505.
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(32) Temporary Female Intraurethral Valve-Pump (CPT Codes 0596T and
0597T)
In the CY 2024 PFS proposed rule, an interested party nominated two
Category III CPT codes, 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. The nominator
expressed concern about variability in MAC pricing for the contractor-
priced service. Additionally, the nominator highlighted that the
payment amounts determined by MACs were inadequately low and did not
account for the time and effort required to furnish the services. In
their submission, the nominator discussed their anticipated inputs for
both codes. For CPT code 0596T, the nominator stated that a physician
typically spends 60 minutes inserting the Vesiflo inFlow System. The
nominator stated that CPT code 0596T included various supplies,
equipment, and clinical labor time totaling $1,902.76, with the inflow
supply items making up about 99 percent of the total cost of supplies.
For CPT code 0597T, the nominator stated that a physician spends 25
minutes replacing the Vesiflo inFlow System and PE items were similar,
with supplies, equipment and clinical labor time costing $505.30, with
the inflow supply items making up about 98 percent of the total cost of
supplies. We direct interested parties to the CY 2024 PFS final rule
(88 FR 78850) for more detailed submission information regarding CPT
codes 0596T and 0597T. After reviewing, we concluded that these codes
were not potentially misvalued because they are Category III codes
describing relatively new and low-volume services. Category III codes
are contractor priced under the PFS, meaning that each MAC can
establish pricing for the code within its jurisdiction, resulting in
variability in payments.
This year, the nominator newly informed CMS that their analysis of
national payment rates showed that in most CMS jurisdictions, not only
are these codes misvalued, but in most cases, they are not valued at
all, with fee schedule amounts in most CMS jurisdictions at or near
zero dollars. The nominator further emphasized that three physician
experts, all employed in major university medical centers, have
highlighted the challenges posed by the combination of high supply
costs and inadequate fee schedule payments, which have hindered their
ability to provide services covered by these codes over several years.
According to the nominator, these selected physicians also expressed
frustration with the reluctance of MACs to address or discuss this
issue. Moreover, the nominator highlighted high access barriers as a
significant concern. These barriers primarily affect Medicare's most
vulnerable beneficiaries, particularly women experiencing permanent
urinary retention (PUR), although we note that no quantifiable evidence
was provided to support these statements. We acknowledge and appreciate
the nominator's efforts in reaching out to experts in the field and
patients who rely on these services to elucidate their significant
needs.
Since these two Category III CPT codes were not identified as
potentially misvalued and were consequently priced by contractors, each
MAC can set pricing for the code within its jurisdiction. This could
result in inevitable variability in MAC pricings until they receive a
higher number of claims, as stated by the nominator. Through our
engagement with MACs, we found that claims for the two Category III CPT
codes are reviewed on a case-by-case basis for medical necessity. If
the claim is payable, the price will be determined at that time by the
MAC. Additionally, these codes were a topic of discussion within the
MAC pricing workgroup, and we observed that there was not a significant
difference among the MACs in terms of allowances based on the proposed
pricing methodologies. However, there is variance in how MACs load
pricing for Category III codes. For instance, some MACs publish the
price for the service before they receive any claims, while others set
the price only after they receive claims that help determine the
appropriate pricing. If a MAC does not load a price for a code before
receiving any claims, the service can still be paid, but the allowance
has not been published.
We continue to hear concerns about these payment inconsistencies
for CPT codes 0596T and 0597T. As a result, we are recommending that
the MACs establish more consistency in pricing, enabling the
appropriate inclusion of the Vesiflo system in the code's PE valuation.
Therefore, for CY 2025, we encourage interested parties to provide more
accurate and appropriate cost data, along with additional information
regarding work RVU, work time, indicators, and utilization estimates
for the MACs. This should complement the information provided by the
nominator in the CY 2024 final rule (88 FR 78850) and will facilitate
the process. To aid in this process, we are adding three new supplies
to our direct PE database based on invoices submitted by interested
parties: the inFlow Measuring Device at a price of $140 (SD370), the
inFlow Valve-Pump Device at a price of $495 (SD371), and the inFlow
Activator Kit at a price of $1,250 (SD372). Although we are not
proposing national pricing for these two Category III codes, we do note
for the benefit of the MACs that CPT code 0596T would typically include
one of each of these supplies, whereas CPT code 0597T would typically
include only one of the supplies (SD371).
We encourage the MACs to continue to engage with interested parties
by providing information on how they price these services. We welcome
additional comments from the broader medical community regarding the
usage of this service, particularly concerning its safety and
effectiveness, as well as potential factors contributing to its low
utilization.
(33) PE-Only Replacement Code for Heart Failure System
Interested parties have expressed concern about the lack of coding
and a billing mechanism when practitioners incur costs replacing
identified components of the CardioMEMSTM Heart Failure
System used in the physician service described by CPT code 33289
(Transcatheter implantation of wireless pulmonary artery pressure
sensor for long-term hemodynamic monitoring, including deployment and
calibration of the sensor, right heart catheterization, selective
pulmonary catheterization, radiological supervision and interpretation,
and pulmonary artery angiography, when performed).
The CardioMEMSTM Heart Failure System furnished during
this service allows practitioners treating heart failure patients to
wirelessly monitor and measure pulmonary artery pressure and heart rate
in patients with heart failure and transmit the information to the
physician to inform the treatment plan for the patient. The system
includes two critical components: first, a miniaturized, wireless
monitor, which is implanted into a patient's pulmonary artery, and
second, a smart pillow (the CardioMEMSTM Patient Electronics
System), which captures and transmits
[[Page 61662]]
readings via safe radio frequency from the patient's implanted
CardioMEMSTM Heart Failure System. Overall, the
CardioMEMSTM Heart Failure System enables patients to
transmit critical heart failure status information to clinicians
regularly, potentially eliminating the need for frequent clinic or
hospital visits.
Interested parties have highlighted the critical importance of the
device for heart failure patients who require close monitoring of
weight and blood pressure to prevent fluid buildup around the heart,
and have requested that CMS establish coding to describe when
practitioners incur costs during clinical scenarios when crucial
components of the system require replacement. Given that these
components are crucial for system functionality and there is no
existing coding framework to address their replacement, we believe that
establishing appropriate coding and payment mechanisms can facilitate
the provision of these services more effectively in the office and
hospital settings. Given provided information, we propose assigning
contractor pricing to this PE-only code for CY 2025. We are proposing a
new code, HCPCS code GMEM1 (Provision of replacement patient
electronics system (for example, system pillow) for home pulmonary
artery pressure monitoring including provision of materials for use in
the home and reporting of test results to physician or qualified health
care professional). We are seeking feedback from interested parties on
our contractor pricing approach with the aim of establishing national
pricing through future rulemaking that can be billed under the OPPS and
PFS specifying an ongoing care visit for the CardioMEMSTM
Heart Failure System along with the provision of the replacement part.
We are specifically looking for information from the broader medical
community regarding direct costs from invoices for the replacement
component referenced above, utilization estimates, and potential
indicators. Additionally, we solicit comments on additional direct PE
inputs that we should consider.
(34) Portable X-Ray (HCPCS Codes R0070-R0075)
Several Portable X-Ray (PXR) suppliers and trade organizations
continue to express longstanding concerns with how payment is
established for transportation related to these services (HCPCS codes
R0070-R0075). CMS has worked with interested parties over the past
several years to understand the costs of these services while taking
into consideration the MACs perspective on pricing of these costs.
Through recent ongoing discussions with interested parties, we learned
that interested parties are concerned with the recognition of costs
incurred from PXR services and are wanting more consistency in the
pricing of these services, including the application of an inflation
factor.
We acknowledge the interested parties' concerns and clarify that
interested parties may best engage with the MACs through appropriate
reporting of cost data in the MAC requested format. This information
provided by interested parties can help MACs establish payment rates
that are more reflective of costs incurred. MACs are then able to
consider this cost information and apply an inflation factor to update
changes in costs year over year.
However, CMS recognizes that we should maintain consistency in
pricing these services that are more indicative of changes in costs
that occur yearly. While still preserving MAC discretion, CMS
highlights the usage of an ambulance inflation factor (AIF) that is
typically used to adjust ambulance services, which include
transportation costs. The AIF is updated annually, and we believe MACs
may consider using the AIF to price PXR services when establishing
payment rates that are more consistent and reflective of costs
incurred.
Additionally, interested parties highlighted inconsistency with
language found in our manual and program memoranda policies related to
transportation costs. Therefore, to remain consistent and transparent
in the pricing of PXR services, we are proposing to revise language in
our Medicare Claims Processing manual (Chapter 13, 90.3 and Chapter 23,
30.5) to reflect any updates to our guidance for these services.
(35) Non-Chemotherapy Administration
CMS received inquiries from several external parties with concerns
that MACs have developed local coverage determinations (LCDs) and local
coverage articles (LCAs) that down code or restrict payment for complex
and non-chemotherapeutic drug administration for CPT code series 96401-
96549, when used for the administration of several biologic and
infusion drugs, including drugs furnished to treat, for example,
rheumatology related conditions.
CMS requested information in the CY 2024 PFS proposed rule (88 FR
52837) seeking public feedback regarding the concerns of down coding or
denials for the administration of non-chemotherapeutic infusion drugs.
We received comments that asked for additional clarification from CMS
regarding the payment guidelines for the complex non-chemotherapeutic
administration code series and updates to the IOM. Commenters urged CMS
to provide additional guidance clarifying the conditions under which
these complex infusion drugs should be payable.
In response to the comments received, and in response to continuing
inquiries on downcoding and or restrictions on payment for non-
chemotherapy complex infusion services, we are proposing an updated
policy based largely on the IOM Medicare Claims Processing Manual,
Chapter 12, section 30.5, to include language currently consistent with
CPT code definitions for the complex non-chemotherapy infusion code
series stating that the administration of infusion for particular kinds
of drugs and biologics can be considered complex and may be
appropriately reported using the chemotherapy administration CPT codes
96401-96549. We note that CPT guidance describes requirements for these
non-chemotherapy complex drugs or biologic agents to include the need
for staff with advanced practice training and competency, such as, a
physician or other qualified health care professional to monitor the
patient during these infusions due to the incidence of severe adverse
reactions. There are also special considerations for preparation,
dosage, or disposal for these infusion drugs. These services do involve
serious patient risk which requires frequent consults with a physician
or other qualified healthcare professional. Based on these facts and
comments, we are proposing to update our subregulatory guidance
accordingly.
This will also provide complex clinical characteristics for the
MACs to consider as criteria when determining payment of claims for
these services. The current IOM language does not include the unique
characteristics of the administration of these drugs that could provide
additional context to the MACs when they are determining appropriate
payment. Updating the IOM with the increased detail of these codes
would be responsive to the concerns and requests of external parties
and will ensure the IOM is consistent with published guidance.
Therefore, we are soliciting and welcome comments on our proposal
to revise the IOM to better reflect how complex non-chemotherapeutic
drug administration infusion services are furnished and billed.
[[Page 61663]]
(36) Hospital Inpatient or Observation (I/O) Evaluation and Management
(E/M) Add-On for Infectious Diseases (HCPCS Code GIDXX)
Interested parties have continued to engage with CMS and provide
recommendations to recognize the increased work associated with
diagnosis, management, and treatment of infectious diseases that may
not be adequately accounted for in current hospital inpatient or
observation E/M codes. Infectious diseases are unique in that they
present infection control risks for the patient and close contacts,
including healthcare staff, that require attention to safely care for
the patient. They present unique challenges in diagnosis in that any
previous healthcare interaction could affect the individual resistance
patterns of pathogens infecting the individual patient and require
close contact with public health agencies since resistance patterns are
constantly changing, so a much more extensive medical review is
required. Additionally, individual decisions regarding treatment are
unique in that use in one patient affects resistance patterns of the
entire population, which requires additional expertise to inform
antimicrobial selection and management.
We believe that the timing is appropriate for establishing a
payment rate for infectious disease physician services since the COVID-
19 PHE has ignited a hypervigilance for infectious diseases. Therefore,
for CY 2025, we are proposing a new HCPCS code to describe intensity
and complexity inherent to hospital inpatient or observation care
associated with a confirmed or suspected infectious disease performed
by a physician with specialized training in infectious diseases. The
full proposed descriptor for the hospital I/O E/M visit complexity add-
on code is HCPCS code GIDXX (Visit complexity inherent to hospital
inpatient or observation care associated with a confirmed or suspected
infectious disease by an infectious diseases consultant, including
disease transmission risk assessment and mitigation, public health
investigation, analysis, and testing, and complex antimicrobial therapy
counseling and treatment. (add-on code, list separately in addition to
hospital inpatient or observation evaluation and management visit,
initial, same day discharge, or subsequent). We anticipate that HCPCS
code GIDXX would be reported by physicians with specialized infectious
disease training.
We do not believe we should limit the scope of codes with which
this proposed add-on HCPCS code could be billed based on visit level;
or initial, same day discharge, or subsequent hospital inpatient or
observation codes. We are proposing HCPCS code GIDXX as an add-on code
(ZZZ global period) separately reportable in addition to CPT codes
99221 (Initial hospital inpatient or observation care, per day, for the
evaluation and management of a patient, which requires a medically
appropriate history and/or examination and straightforward or low level
medical decision making. When using total time on the date of the
encounter for code selection, 40 minutes must be met or exceeded.),
99222 (Initial hospital inpatient or observation care, per day, for the
evaluation and management of a patient, which requires a medically
appropriate history and/or examination and moderate level of medical
decision making. When using total time on the date of the encounter for
code selection, 55 minutes must be met or exceeded.), 99223 (Initial
hospital inpatient or observation care, per day, for the evaluation and
management of a patient, which requires a medically appropriate history
and/or examination and high level of medical decision making. When
using total time on the date of the encounter for code selection, 75
minutes must be met or exceeded.), 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.), 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.), 99234 (Hospital inpatient or observation care,
for the evaluation and management of a patient including admission and
discharge on the same date, which requires a medically appropriate
history and/or examination and straightforward or low level of medical
decision making. When using total time on the date of the encounter for
code selection, 45 minutes must be met or exceeded.), 99235 (Hospital
inpatient or observation care, for the evaluation and management of a
patient including admission and discharge on the same date, which
requires a medically appropriate history and/or examination and
moderate level of medical decision making. When using total time on the
date of the encounter for code selection, 70 minutes must be met or
exceeded.), and 99236 (Hospital inpatient or observation care, for the
evaluation and management of a patient including admission and
discharge on the same date, which requires a medically appropriate
history and/or examination and high level of medical decision making.
When using total time on the date of the encounter for code selection,
85 minutes must be met or exceeded.). Based on feedback from commenters
on the CY 2022 PFS proposed rule comment solicitation regarding
infectious diseases (86 FR 65125 through 65126) and feedback from
interested parties, HCPCS code GIDXX would include the following
proposed service elements:
1. Disease Transmission Risk Assessment and Mitigation
Developing, following, and supervising specialized,
individualized infection control protocols for an individual patient
based on their diagnosis and risks in order to reduce risk of disease
transmission.
Coordinating with human resources regarding infection
prevention and control measures to enable healthcare facility staff to
safely care for patient.
Counseling patients, family members and caregivers
regarding infection prevention.
Managing infection prevention and treatment protocols
associated with transitions of care for complex patients.
2. Public Health Investigation, Analysis, and Testing
In-depth patient chart review that entails going back
farther in time and assessing the complete breadth of all health care
interactions, with higher-level synthesis for complex diagnoses.
Communicating with the clinical microbiology lab and
directly reviewing specimens.
Coordinating specialized diagnostic evaluations (for
example, identifying and facilitating diagnostic laboratory tests only
available at specialized laboratories, the state health
[[Page 61664]]
department, and/or the Centers for Disease Control & Prevention).
Coordinating with Federal, State and local public health
agencies and laboratories to assist with contact tracing, obtaining
specimens for specialized testing, and/or identifying prior testing and
treatment for communicable diseases in other jurisdictions.
3. Complex Antimicrobial Therapy Counseling & Treatment
Counseling patients, family members, and caregivers
regarding antimicrobial stewardship and resistance for the patient.
Engaging in complex medical decision-making associated
with antimicrobial prescribing including considerations such as
antimicrobial resistance patterns, emergence of new variants/strains,
recent antibiotic exposure, interactions/complications from
comorbidities including concurrent infections, public health
considerations to minimize development of antimicrobial resistance, and
emerging and re-emerging infections.
For HCPCS code GIDXX, we are proposing a work RVU of 0.89 based on
the work RVU for 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)), which is 0.33, multiplied
by a ratio of the work RVUs for CPT codes 99223 and 99213 (Office or
other outpatient visit for the evaluation and management of an
established patient, which requires a medically appropriate history
and/or examination and low level of medical decision making. When using
total time on the date of the encounter for code selection, 20 minutes
must be met or exceeded.), 3.50 and 1.30, respectively. (This ratio is
the work RVU of CPT code 99223 divided by the work RVU of CPT code
99213, 3.50 divided by 1.30, which equals 2.69. Multiplying the 0.33
work RVU of HCPCS code G2211 times 2.69 results in our proposed work
RVU of 0.89.) We believe the relationship between the complexity add-on
HCPCS code G2211 and a common base code for the add-on code, CPT code
99213, would strike the correct balance to estimate the time and
complexity associated with the new HCPCS code GIDXX, compared to what
we believe will be a common base code for this new add-on code, CPT
code 99223. HCPCS code G2211 has a total time of 11 minutes, therefore,
we are proposing a total time of 30 minutes for HCPCS code GIDXX based
on the same ratio (11 minutes times the same 2.69 ratio equals 30
minutes). HCPCS code G2211 has no direct PE inputs, and we are
proposing the same for HCPCS code GIDXX.
We believe that the proposed work RVU appropriately falls between
the following bracket add-on codes: HCPCS code G0316 (Prolonged
hospital inpatient or observation care evaluation and management
service(s) beyond the total time for the primary service (when the
primary service has been selected using time on the date of the primary
service); each additional 15 minutes by the physician or qualified
healthcare professional, with or without direct patient contact (list
separately in addition to CPT codes 99223, 99233, and 99236 for
hospital inpatient or observation care evaluation and management
services). (do not report g0316 on the same date of service as other
prolonged services for evaluation and management 99358, 99359, 99418,
99415, 99416). (do not report g0316 for any time unit less than 15
minutes)) with a work RVU of 0.61 and the professional principal care
management, chronic care management, and complex chronic care
management CPT codes 99425 (Principal care management services, for a
single high-risk disease, with the following required elements: one
complex chronic condition expected to last at least 3 months, and that
places the patient at significant risk of hospitalization, acute
exacerbation/decompensation, functional decline, or death, the
condition requires development, monitoring, or revision of disease-
specific care plan, the condition requires frequent adjustments in the
medication regimen and/or the management of the condition is unusually
complex due to comorbidities, ongoing communication and care
coordination between relevant practitioners furnishing care; each
additional 30 minutes provided personally by a physician or other
qualified health care professional, per calendar month (List separately
in addition to code for primary procedure)), 99437 (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 30
minutes by a physician or other qualified health care professional, per
calendar month (List separately in addition to code for primary
procedure)), and 99489 (Complex chronic care management services with
the following required elements: multiple (two or more) chronic
conditions expected to last at least 12 months, or until the death of
the patient, chronic conditions that place the patient at significant
risk of death, acute exacerbation/decompensation, or functional
decline, comprehensive care plan established, implemented, revised, or
monitored, moderate or high complexity medical decision making; each
additional 30 minutes of clinical staff time directed by a physician or
other qualified health care professional, per calendar month (List
separately in addition to code for primary procedure)) with work RVUs
of 1.00.
To help inform whether our proposed descriptor is appropriate and
reflects the typical service, we are seeking comment on the typical
amount of time infectious disease physicians spend on the proposed
service elements and the relative intensity compared to similar service
elements of other CPT codes. We note that the valuation of HCPCS code
GIDXX is meant to capture the visit complexity inherent to hospital
inpatient or observation care associated with a confirmed or suspected
infectious disease by an infectious diseases consultant that is not
accounted for in the appropriate hospital inpatient or observation E/M
base code billed by the infectious disease physician.
Interested parties have stated that consultations are a common E/M
service performed by infectious disease clinicians, particularly in the
inpatient setting, but stated that these services are no longer
recognized by Medicare. Interested parties have also stated that this
has resulted in a significant reduction in reporting and payment for
infectious disease physician services. We note that we address this in
the CMS Claims Processing Manual, Chapter 12, section 30.6.9 F, stating
that ``Physicians may bill initial hospital care service codes (99221-
99223), for services that were reported with CPT consultation codes
(99241-99255) prior to January 1, 2010, when the furnished service and
documentation meet the minimum key component work and/or medical
necessity requirements. Physicians may report a subsequent hospital
care CPT code for services that were reported as CPT consultation codes
(99241-99255)
[[Page 61665]]
prior to January 1, 2010, where the medical record appropriately
demonstrates that the work and medical necessity requirements are met
for reporting a subsequent hospital care code (under the level
selected), even though the reported code is for the provider's first E/
M service to the inpatient during the hospital stay.'' Accordingly, we
are seeking comment on any potential barriers for infectious disease
physicians to use the initial and subsequent day hospital inpatient or
observation codes, CPT codes 99221 through 99223 and 99231 through
99233, for consultations if they meet the coding requirements for time
and/or medical decision making (MDM). We note that understanding the
barriers to utilizing these codes is important, as these codes will
serve as the base codes for HCPCS code GIDXX, and will need to be
billed by the infectious disease physician prior to billing HCPCS code
GIDXX.
Finally, we recognize that historically, the CPT Editorial Panel
has frequently created CPT codes describing services that we originally
established using G codes and adopted them through the CPT Editorial
Panel process. We note that we would consider using any newly available
CPT coding to describe services similar to those described here in
future rulemaking.
(37) Preexposure Prophylaxis (PrEP) of Human Immunodeficiency Virus
(HIV)
To facilitate prompt beneficiary access to PrEP for CY 2024, we
established 3 HCPCS G codes that describe the service of counseling and
administration of Human Immunodeficiency Virus (HIV) pre-exposure
prophylaxis drugs. Specifically, HCPCS codes G0011 (Individual
counseling for pre-exposure prophylaxis (PrEP) by physician or QHP to
prevent human immunodeficiency virus (HIV), includes: HIV risk
assessment (initial or continued assessment of risk), HIV risk
reduction and medication adherence, 15-30 minutes) and G0013
(Individual counseling for pre-exposure prophylaxis (PrEP) by clinical
staff to prevent human immunodeficiency virus (HIV), includes: HIV risk
assessment (initial or continued assessment of risk), HIV risk
reduction and medication adherence) describe the counseling portion of
the service, and G0012 (Injection of pre-exposure prophylaxis (PrEP)
drug for HIV prevention, under skin or into muscle) describes the
injection of the medication.
CMS released a Proposed NCD for Pre-Exposure Prophylaxis (PrEP) for
Human Immunodeficiency Virus (HIV) Infection Prevention on July 12,
2023. This proposed NCD announced CMS' intent to cover and pay for
those drugs under the 1861(ddd) additional preventive services
authority, and a final decision on the NCD is forthcoming. For CY 2025,
we are proposing national rates for these HCPCS codes that reflect the
relative resource costs associated with the counseling and drug
administration portions of the service, pending finalization of the
NCD. For HCPCS code G0011, we are proposing a work RVU of 0.45 based
off work and direct PE inputs crosswalked from HCPCS code G0445 (High
intensity behavioral counseling to prevent sexually transmitted
infection; face-to-face, individual, includes: education, skills
training and guidance on how to change sexual behavior; performed semi-
annually, 30 minutes). For HCPCS code G0012, we are proposing a work
RVU of 0.17 based on the work and direct PE crosswalked from CPT code
96372 (Therapeutic, prophylactic, or diagnostic injection (specify
substance or drug); subcutaneous or intramuscular), and for HCPCS code
G0013 we are proposing a work RVU of 0.18 based on the work and direct
PE inputs crosswalked from 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). We appreciate having this opportunity for
interested parties to provide feedback on the most accurate way to
value these services.
(38) Opfolda
For CY 2024, to facilitate beneficiary access to treatment of late-
onset Pompe disease with miglustat in combination with cipaglucosidae
alfa-atga, we created a new HCPCS code, G0138, describing the service
of administration of cipaglucosidase alfa-atga (Pombiliti), which
includes the intravenous administration of cipaglucosidase alfa-atga,
the provider or supplier's acquisition cost of miglustat, clinical
supervision, and oral administration of miglustat. HCPCS code G0138
(Intravenous infusion of cipaglucosidase alfaatga, including provider/
supplier acquisition and clinical supervision of oral administration of
miglustat in preparation of receipt of cipaglucosidase alfa-atga) was
added to the PFS effective April 1, 2024, as a contractor priced
service. More information regarding the creation of HCPCS code G0138
can be found at https://www.cms.gov/files/document/2023-hcpcs-application-summary-quarter-4-2023-drugs-and-biologicals-updated-1/30/2024.pdf.
For CY 2025, we are proposing national pricing for this service
that reflects the relative resource costs associated with the infusion
administration of Cipaglucosidae alfa-atga and clinical supervision and
provision of Miglustat oral with acquisition costs. We are proposing a
work RVU of 0.21 for HCPCS code G0138 based on a crosswalk from CPT
code 96365 (Intravenous infusion, for therapy, prophylaxis, or
diagnosis (specify substance or drug); initial, up to 1 hour). This
includes a crosswalked total time of 9 minutes and an intraservice time
of 5 minutes. We are also proposing to crosswalk the direct PE inputs
from CPT code 96365 for use in valuing HCPCS code G0138. However, we
are adding 1 minute of L056A clinical staff time during the preservice
portion of the service period to capture the RN/OCN observation of the
patient during administration of the Opfolda pill. In addition, to
account for the cost of the provision of the self-administered Opfolda
as a direct PE input, we are incorporating the wholesale acquisition
cost (WAC) data from the most recent available quarter. We are
proposing a price of $32.50 for the supply input that describes a 65mg
capsule of Opfolda (supply code SH111). We are seeking feedback from
interested parties on our proposal of national pricing, as well as our
proposed work RVU and direct PE inputs for HCPCS code G0138 to ensure
proper payment for this service.
(39) Payment for Caregiver Training Services
a. Background
In the CY 2017 PFS final rule (81 FR 80330 through 80331), we
finalized payment for new CPT code(s) describing administration of a
patient-focused health risk assessment instrument as well as
administration of a caregiver-focused health risk assessment
instrument. In the CY 2024 PFS final rule (88 FR 78914), we finalized
the assignment of a payable status for caregiver training services
(CTS) for therapy and behavior management/modification services
(without the patient present) and finalized the RUC-recommended
valuations for these services to better recognize the role that
caregivers play in reasonable and necessary care for Medicare
beneficiaries. 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
[[Page 61666]]
strategies and specific activities to assist the patient in carrying
out the treatment plan.
We finalized in the CY 2024 PFS final rule 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 also finalized 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. Additionally, we
finalized 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. These
finalized policies apply to current CTS coding and we are also
proposing for them to apply to the newly proposed CTS coding that
follows. We continue to receive questions and requests from interested
parties about how we can refine payment for these services.
b. Caregiver Assessment
In response to interested parties' requests for assessment of a
caregiver's knowledge to be included in caregiver training, we are
clarifying that when reasonable and necessary, assessing the
caregiver's skills and knowledge for the purposes of caregiver training
services could be included in the service described by CPT code 96161
(Administration of caregiver-focused health risk assessment instrument
(e.g., depression inventory) for the benefit of the patient, with
scoring and documentation, per standardized instrument) to determine if
caregiver training services are needed. We also note that CPT code
96161 is currently on the Medicare Telehealth list.
We note that, as specified in the CY 2017 PFS final rule (81 FR
80330), in particular cases, caregiver-focused health risk assessments
can be necessary components of services furnished to Medicare
beneficiaries. Examples where this service may be reasonable and
necessary may include assessment of maternal depression in the active
care of infants, assessment of parental mental health as part of
evaluating a child's functioning, assessment of caretaker conditions as
indicated where atypical parent/child interactions are observed during
care, and assessment of caregivers as part of care management for
adults whose physical or cognitive status renders them incapable of
independent living and dependent on another adult caregiver. Commenters
cited that some examples of such individuals might include
intellectually disabled adults, seriously disabled military veterans,
and adults with significant musculoskeletal or central nervous system
impairments (81 FR 80331).
We are proposing that because the caregiver-focused health risk
assessment may be furnished outside the patient's presence, the
treating practitioner must obtain the patient's (or representative's)
consent for the caregiver to receive the assessment. We are also
proposing that the definition of ``caregiver'' specified in the CY 2024
PFS final rule (88 FR 78917) will be the same for caregiver training
services and the caregiver-focused health risk assessment.
We are seeking comment on these proposals and clarifications.
c. Proposals and New Coding
(A) Proposed Direct Care Caregiver Training Services
i. Coding
We are proposing to establish new coding and payment for caregiver
training for direct care services and supports. The topics of training
could include, but would not be limited to, techniques to prevent
decubitus ulcer formation, wound dressing changes, and infection
control. Unlike other caregiver training codes that are currently paid
under the PFS, the caregiver training codes for direct care services
and support focus on specific clinical skills aimed at the caregiver
effectuating hands-on treatment, reducing complications, and monitoring
the patient. For example, in the direct care CTS codes, a caregiver
could be taught how to properly change wound dressings to promote
healing and prevent infection. This skill, among other direct care
services, would not fall into the categories of CTS codes that
currently exist (behavior management/modification or strategies and
techniques to facilitate the patient's functional performance in the
home or community) but is integral in effectuating the patient's
treatment plan. Like other codes describing caregiver training
services, these proposed new codes would reflect 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. 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
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.
We are proposing three new HCPCS codes: GCTD1 (Caregiver training
in direct care strategies and techniques to support care for patients
with an ongoing condition or illness and to reduce complications
(including, but not limited to, techniques to prevent decubitus ulcer
formation, wound dressing changes, and infection control) (without the
patient present), face-to-face; initial 30 minutes), GCTD2 (Caregiver
training in direct care strategies and techniques to support care for
patients with an ongoing condition or illness and to reduce
complications (including, but not limited to, techniques to prevent
decubitus ulcer formation, wound dressing changes, and infection
control) (without the patient present), face-to-face; each additional
15 minutes (List separately in addition to code for primary service)
(Use GCTD2 in conjunction with GCTD1)), and GCTD3 (Group caregiver
training in direct care strategies and techniques to support care for
patients with an ongoing condition or illness and to reduce
complications (including, but not limited to, techniques to prevent
decubitus ulcer formation, wound dressing changes, and infection
control) (without the patient present), face-to-face with multiple sets
of caregivers)).
We continue to believe that CTS may be reasonable and necessary
when they are integral to a patient's overall treatment and furnished
after the treatment plan is established. The medical or direct care 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. Direct care
training for caregivers of Medicare beneficiaries 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 training activity should be clearly identified
and documented in the treatment plan. Additionally, this would not be
billable for patients under home
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health plan of care, receiving at-home therapy, or receiving DME
services for involved medical equipment and supplies.
We are seeking additional information from commenters about
potential service overlaps and potential examples of direct care
services to receive caregiver training to inform our final policy. We
are soliciting public comment on each of our proposals for direct care
CTS.
ii. Valuation
For GCTM1, we propose a direct crosswalk to CPT Code 97550
(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), with a work RVU of 1.00 as we believe this service
reflects the resource costs associated when the billing practitioner
performs HCPCS code GCTM1. CPT code 97550 has an intraservice time of
30 minutes, and the physician work is of similar intensity to our
proposed HCPCS code GCTM1. Therefore, we are proposing a work time of
30 minutes intraservice time (40 minutes of total time) for HCPCS code
GCTM1 based on this same crosswalk to CPT 97550. We are also proposing
to use this crosswalk to establish the direct PE inputs for HCPCS code
GCTM1.
For GCTM2, we are proposing a direct crosswalk to CPT Code 97551
(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;
each additional 15 minutes (List separately in addition to code for
primary service)), with a work RVU of 0.54 as we believe this service
reflects the resource costs associated when the billing practitioner
performs HCPCS code GCTM2. CPT code 97551 has an intraservice time of
17 minutes, and the physician work is of similar intensity to our
proposed HCPCS code GCTM2. Therefore, we are proposing a work time of
17 minutes for HCPCS code GCTM2 based on this same crosswalk to CPT
97551. We also propose to use this crosswalk to establish the direct PE
inputs for HCPCS code GCTM2.
For GCTM3, we propose a direct crosswalk to CPT Code 97552 (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), with a work RVU of 0.23 as we
believe this service reflects the resource costs associated when the
billing practitioner performs HCPCS code GCTM3. CPT code 97552 has an
intraservice time of 9 minutes, and the physician work is of similar
intensity to our proposed HCPCS code GCTM1. Therefore, we are proposing
a work time of 9 minutes intraservice time (14 minutes total time) for
HCPCS code GCTM3 based on this same crosswalk to CPT 97552. We are also
proposing to use this crosswalk to establish the direct PE inputs for
HCPCS code GCTM3.
We are seeking comment on supplies/equipment that would be typical
for the newly created direct care strategies and techniques CTS codes.
We believe these services would largely involve contact between the
billing practitioner and the caregiver through in-person interactions,
which could be conducted via telecommunications, as appropriate.
Therefore, we are proposing to add these codes to the Medicare
Telehealth Services List to accommodate a scenario in which the
practitioner completes the caregiver training service via telehealth.
Please see section II.D. for more information on Medicare Telehealth
Services.
We are seeking comments on these proposals.
(B) Individual Behavior Management/Modification Caregiver Training
Services
i. Coding
We are proposing to establish new coding and payment for caregiver
behavior management and modification training that could be furnished
to the caregiver(s) of an individual patient. Current CPT coding (CPT
96202 and 96203) allows for ``multiple-family group behavior
management/modification training services,'' meaning that this
caregiver training service can only be furnished in a group setting
with multiple sets of caregivers of multiple beneficiaries (please
reference 88 FR 78818 for discussion of CPT 96202 and 96203). We are
proposing two new HCPCS codes: GCTB1 (Caregiver training in behavior
management/modification for caregiver(s) of a patient with a mental or
physical health diagnosis, administered by physician or other qualified
health care professional (without the patient present), face-to-face;
initial 30 minutes) and GCTB2 (Caregiver training in behavior
management/modification for caregiver(s) of a patient with a mental or
physical health diagnosis, administered by physician or other qualified
health care professional (without the patient present), face-to-face;
each additional 15 minutes (List separately in addition to code for
primary service) (Use GCTB2 in conjunction with GCTB1)).
We continue to believe that CTS may be reasonable and necessary
when they are integral to a patient's overall treatment and furnished
after the treatment plan is established. The behavior management/
modification 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. Behavior management/modification training for caregivers of
Medicare beneficiaries 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
training activity should be clearly identified and documented in the
treatment plan. All other policies and procedures surrounding CPT 96202
and 96203 will also apply to these services (88 FR 78914-78920).
We are seeking comment on these proposals.
ii. Valuation
For GCTB1, we propose a direct crosswalk to CPT Code 97550
(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), with a work RVU of 1.00 as we believe this service
reflects the resource costs associated when the billing practitioner
performs HCPCS code GCTB1. CPT code 97550 has an intraservice time of
30 minutes, and the physician work is of similar intensity to our
proposed HCPCS code GCTB1. Therefore, we are proposing a work time of
30 minutes
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intraservice time (40 minutes of total time) for HCPCS code GCTB1 based
on this same crosswalk to CPT 97550. We also propose to use this
crosswalk to establish the direct PE inputs for HCPCS code GCTB1. We
are seeking comment on supplies/equipment that would be typical for the
newly created individual behavior management/modification CTS codes.
For GCTB2, we propose a direct crosswalk to CPT Code 97551
(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;
each additional 15 minutes (List separately in addition to code for
primary service)), with a work RVU of 0.54 as we believe this service
reflects the resource costs associated when the billing practitioner
performs HCPCS code GCTB2. CPT code 97551 has an intraservice time of
17 minutes, and the physician work is of similar intensity to our
proposed HCPCS code GCTB2. Therefore, we are proposing a work time of
17 minutes for HCPCS code GCTB2 based on this same crosswalk to CPT
97551. We also propose to use this crosswalk to establish the direct PE
inputs for HCPCS code GCTB2.
We are seeking comment on supplies/equipment that would be typical
for the newly created individual behavior management/modification CTS
codes.
We believe these services would largely involve contact between the
billing practitioner and the caregiver through in-person interactions,
which could be conducted via telecommunications as appropriate.
Therefore, we are proposing to add these codes to the Medicare
Telehealth Services List to accommodate a scenario in which the
practitioner completes the caregiver training service via telehealth.
Please see section II.D. for more information on Medicare Telehealth
Services.
We are seeking comments on these proposals.
(C) Patient Consent
In the CY 2024 PFS final rule (88 FR 78916), we finalized a
requirement that the treating practitioner must obtain the patient's
(or representative's) consent for the caregiver to receive the CTS and
that the identified need for CTS and the patient's (or
representative's) consent for one or more specific caregivers to
receive CTS be documented in the patient's medical record.
We are proposing that consent for CTS can be provided verbally by
the patient (or representative). This would align consent requirements
with other services paid under the PFS that may be furnished without
the patient present, such as certain care management services. This
proposal would apply to CPT codes 97550, 97551, 97552, 96202, and
96203, as well as any caregiver training services HCPCS codes finalized
in this year's rule, and any subsequently created caregiver training
service codes. We are seeking comment on this proposal.
(D) Addition to Telehealth List
Please see section II.D. of this proposed rule, Payment for
Medicare Telehealth Services, for the discussion related to proposals
to add CTS to the Medicare Telehealth list.
(40) Request for Information for Services Addressing Health-Related
Social Needs (Community Health Integration (G0019, G0022), Principal
Illness Navigation (G0023, G0024), Principal Illness Navigation--Peer
Support (G0140, G0146), and Social Determinants of Health Risk
Assessment (G0136))
a. Background
In the CY 2024 PFS final rule (88 FR 78920), we finalized G-codes
to reflect new coding and payment for services describing Community
Health Integration (CHI), G0019 (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), and G0022 (Community
health integration services, each additional 30 minutes per calendar
month), which may include a community health worker (CHW), incident to
the professional services and under the general supervision of the
billing practitioner. We finalized a new stand-alone G code describing
a SDOH Risk Assessment, G0136 (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 also finalized PIN services, described by HCPCS code
G0023 (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) and G0024 (Principal Illness
Navigation services, additional 30 minutes per calendar month); G0140
(Principal Illness Navigation--Peer Support by certified or trained
auxiliary personnel under the direction of a physician or other
practitioner, including a certified peer specialist; 60 minutes per
calendar month) and G0146 (Principal Illness Navigation--Peer Support,
additional 30 minutes per calendar month), 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 support 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.
b. Request for Information on Services Addressing Health-Related Social
Needs
For CY 2025 we are issuing a broad request for information (RFI) on
the newly implemented Community Health Integration (CHI) (HPCCS codes
G0019, G0022), Principal Illness Navigation (PIN) (HCPCS codes G0023,
G0024), Principal Illness Navigation--Peer Support (PIN-PS) (HCPCS
codes G0140, G0146), and Social Determinants of Health Risk Assessment
(SDOH RA) (HCPCS code G0136) services to engage interested parties on
additional policy refinements for CMS to consider in future rulemaking.
We are interested in better addressing the social needs of
beneficiaries and requesting information on the codes we created and
finalized beginning in CY 2024 to fully encompass what interested
parties and commenters believe should be included in the coding and
payment we recently established. We are seeking comment on any related
services that may not be described by the current coding that we
finalized in the CY 2024 PFS final rule and that are medically
reasonable and necessary ``for the diagnosis or treatment of illness or
injury'' under section 1862(a)(1)(A) of the Act. We believe we can work
within the current coding framework and explore additional
opportunities to create codes that describe reasonable and necessary
services furnished by billing practitioners and the auxiliary personnel
under their general supervision. We are interested in feedback
regarding any barriers to furnishing the services addressing health-
related social needs, and if the
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service described by the codes we established are allowing
practitioners to better address unmet social needs that interfere with
the practitioners' ability to diagnose and treat the patient. This
could include barriers specific to certain populations, including rural
and tribal communities, residents of the U.S. Territories, individuals
with disabilities, individuals with limited English proficiency, or
other populations who experience specific unmet social needs.
In response to the CY 2024 PFS proposed rule, we heard from
commenters that CSWs often connect individuals with community-based
resources to address unmet social needs that affect the diagnosis and
treatment of medical problems. CSWs can bill Medicare directly for
services they personally perform for the diagnosis or treatment of
mental illness but are not authorized by statute to bill for services
that are provided by auxiliary personnel incident to their professional
services. Since CHI and PIN codes are typically provided by auxiliary
personnel supervised by the billing practitioner, CSWs could serve as
the auxiliary personnel. CSWs could not directly bill Medicare for CHI
and PIN services if they were provided by auxiliary personnel, as they
are not authorized to supervise, bill, and be paid directly by Medicare
for services that are provided by auxiliary personnel incident to their
professional services. We believe the current CHI and PIN coding
accurately captures the services CSWs currently provide, including the
work involved in connecting beneficiaries with community-based
resources for unmet social needs that affect the diagnosis or treatment
of medical problems. As we stated previously in the CY 2024 PFS final
rule (88 FR 78926), ``the codes do not limit the types of other health
care professionals, such as registered nurses and social workers, that
can perform CHI services (and PIN services, as we discuss in the next
section) incident to the billing practitioner's professional services,
so long as they meet the requirements to provide all elements of the
service included in the code, consistent with the definition of
auxiliary personnel at Sec. 410.26(a)(1).'' We are clarifying that
when we refer to ``certified or trained auxiliary personnel'' in the
following codes: G0019, G0022, G0023, G0024, G0140, G0146, this also
includes CSWs.
We are requesting information if there are other types of auxiliary
personnel, other certifications, and/or training requirements that are
not adequately captured in current coding and payment for these
services. We are also interested in hearing more about what types of
auxiliary personnel are typically furnishing these services, including
the certifications and/or licensure that they have. We are also
interested in whether there are nuances or considerations that CMS
should understand related to auxiliary personnel and training,
certifications or licensure barriers or requirements that are
specifically experienced by practitioners serving underserved
communities. This could include settings such as community mental
health centers, community health clinics including FQHCs and RHCs,
tribal health centers, migrant farmworker clinics, or facilities
located in and serving rural and geographically isolated communities
including the U.S. Territories.
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.
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. We stated
that, 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 and PIN services. We
stated that we understood that many community-based organizations
(CBOs) provide social services and do other work that is beyond the
scope of CHI and PIN services, but we believed they are well-positioned
to develop relationships with practitioners for providing reasonable
and necessary CHI and PIN services.
We are interested in hearing more about CBOs and their
collaborative relationships with billing practitioners. The new codes
for CHI and PIN services recognized CBOs and their role in providing
auxiliary personnel under the general supervision of the billing
practitioners. We are seeking comment regarding the extent to which
practitioners are contracting with CBOs (including current or planned
contracting arrangements) for auxiliary personnel purposes, and if
there is anything else CMS should do to clarify services where
auxiliary personnel can be employed by the CBO, so long as they are
under the general supervision of the billing practitioner. Given that
the CHI and PIN services may be provided incident to the billing
practitioner's professional services, we are also seeking comment on
whether the incident to billing construct is appropriate for CBOs to
supplement pre-existing staffing arrangements and the CBO/provider
interface. We are also seeking comment on CBOs' roles, the extent to
which practitioners are contracting with CBOs, incident to billing, and
auxiliary personnel employed by CBOs under general supervision of
practitioners serving and located in rural, tribal and geographically
isolated communities, including the U.S. Territories.
We are also interested in any comments from interested parties
across provider types and from practitioners in geographically isolated
communities (for example, rural, tribal, and island communities) and
otherwise underserved communities about coding Z codes on claims
associated with billing for CHI, PIN, and SDOH risk assessment codes.
We recognize that when screening for social needs, such needs may be
identified and are interested in learning whether practitioners are
also capturing unmet social needs on claims using Z codes for social
risk factors or in some other way, and any barriers or opportunities to
increase coding of Z codes when social risk factors screen positive.
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 and
addressing unmet social needs that affect the diagnosis and treatment
of medical problems. Given the Agency's broader policy goals of
increasing access to care, we are requesting information from
interested parties and commenters on anything else that we should
consider in the context of these codes and what else we could consider
to be included in this newly established code set.
We are seeking comments on ways to identify specific services and
to recognize possible barriers to improved access to these kinds of
high-value,
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potentially underutilized services by Medicare beneficiaries.
We are seeking public comment to understand more clearly how often
evidence-based care for persons with fractures, for example, is not
provided and the reasons for this, and how recent or new PFS codes, or
their revaluation, might help resolve specific barriers to its
provision. The PFS currently includes many codes that pay for various
components of care to manage patients with fractures over a course of
treatment, such as transitional care management (TCM) and other care
management services, evaluation and management visits (including the
inherent complexity add-on for office/outpatient visits), principal
illness navigation services, community health integration services, and
the social determinants of health risk assessment. We refer readers to
our recent guidance on these services on the CMS website at https://www.cms.gov/files/document/health-related-social-needs-faq.pdf.
Medicare also pays for bone mass measurement/density tests (MLN006559--
https://www.cms.gov/medicare/prevention/prevntiongeninfo/medicare-preventive-services/mps-quickreferencechart-1.html#BONE_MASS, and for
outpatient osteoporosis medication under Part D and, in some cases,
Part B (https://www.medicare.gov/coverage/osteoporosis-drugs). These
services can be billed on their own, or in combination, where
applicable. We note that in the CY 2020 PFS final rule (84 FR 62685)
and CY 2021 PFS final rule (85 FR 84547), CMS indicated that TCM may be
billed concurrently with other care management codes when relevant,
medically necessary, and not duplicative.
We are proposing new coding in other sections of this CY 2025
proposed rule that might be used to bill for managing fractures under a
treatment plan, including the global post-operative add-on code, HCPCS
code GPOC1, in section II.G.5 of this proposed rule and the advanced
primary care management codes in section II.G.2 of this proposed rule.
Interested parties have indicated that orthopedic surgeons, skilled
nursing facilities (SNFs), and other practitioners and providers may
not be providing comprehensive patient centered fracture management
care for quality, payment, or administrative reasons, and that there is
inadequate ``hand-off'' when post-discharge fracture care is
transferred to practitioners in the community. They indicate a systemic
disconnect on which provider and/or specialty is responsible for
osteoporosis diagnosis and treatment, and that global surgical periods
focus on acute fracture recovery rather than addressing osteoporosis.
We are interested in hearing if the proposed global postop add-on code
could help resolve these issues.
BILLING CODE P
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F. Evaluation and Management (E/M) Visits
1. Office/Outpatient (O/O) Evaluation and Management (E/M) Visit
Complexity Add-On
In the CY 2024 PFS final rule (88 FR 78970 through 78982), we
finalized separate payment for the O/O E/M visit complexity add-on
code. The full descriptor for the O/O E/M visit complexity add-on code,
HCPCS code G2211, is (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)).
The O/O E/M visit complexity add-on code ``reflects the time,
intensity, and PE resources involved when practitioners furnish the
kinds of O/O E/M visit services that enable them to build longitudinal
relationships with all patients (that is, not only those patients who
have a chronic condition or single high-risk disease) and to address
the majority of a patient's health care needs with consistency and
continuity over longer periods of time.'' (88 FR 78970
[[Page 61697]]
through 78971). We explained in the CY 2024 PFS final rule that it is
the relationship between the patient and the practitioner that is the
determining factor for when the add-on code should be billed. The add-
on code captures the inherent complexity of the visit that is derived
from the longitudinal nature of the practitioner and patient
relationship. The first part of the code descriptor, the ``continuing
focal point for all needed health care services,'' describes a
relationship between the patient and the practitioner when the
practitioner is the continuing focal point for all health care services
that the patient needs. The second part of the add-on code also
describes a relationship involving medical services that are part of
ongoing care related to a patient's single, serious condition or a
complex condition. There is previously unrecognized but important
cognitive effort of utilizing the longitudinal relationship in making a
diagnosis, developing a treatment plan, and weighing the factors that
affect a longitudinal doctor-patient relationship. The practitioner
must decide what course of action and choice of words in the visit
itself would lead to the best health outcome in the single visit while
simultaneously building up an effective, trusting longitudinal
relationship with the patient. Weighing these various factors, even for
a seemingly simple condition, makes the entire visit inherently
complex, which is what this add-on code is intended to capture (88 FR
78973 through 78974).
We responded to concerns raised by commenters about potential
duplicative payment and potential misreporting of the code, noting that
when procedures or other services are reported on the same day by the
same billing practitioner as a significant, separately identifiable O/O
E/M visit (the base codes that the visit complexity add-on code can be
billed with), we believed that the services involve resources that are
sufficiently distinct from the costs associated with furnishing stand-
alone O/O E/M visits to warrant a different payment policy (88 FR
78971). We finalized our proposal that the O/O E/M visit complexity
add-on code is not payable when the O/O E/M visit is reported with CPT
Modifier-25, which denotes a significant, separately identifiable O/O
E/M visit by the same physician or other qualified health care
professional on the same day as a procedure or other service (88 FR
78974).
Some commenters expressed concern about our proposal to exclude
payment for the visit complexity add-on code when the O/O E/M base code
is reported with Modifier-25 because some preventive services such as
the annual wellness visit (AWV) or a preventive vaccine are often
provided on the same day as a separately identifiable O/O E/M visit,
appropriately billed with Modifier-25. The commenters were concerned
that practitioners might avoid the policy by not providing a preventive
service on the same day as another O/O E/M service. We acknowledged
that immunizations and AWVs were sometimes furnished on the same day as
an O/O E/M visit and that our policy would prevent payment of the add-
on code with such office visits billed with Modifier-25 and indicated
that we would monitor utilization of the visit complexity add-on code
and continue engagement with interested parties as the policy is
implemented (88 FR 78975).
We have begun to monitor utilization of HCPCS code G2211 and are
continuing to engage with interested parties. We continue to hear from
some practitioners that our non-payment of the O/O E/M visit complexity
add-on code when the O/O E/M base code is reported on the same day as a
preventive immunization or other Medicare preventive service is
disruptive to the way such care is usually furnished and contrary to
our policy objective for establishing the add-on payment. An early
analysis of practitioner claims from the first few months of 2024 shows
relatively few Medicare preventive services being billed on the day
preceding or following an O/O E/M visit. We cannot conclude from this
analysis that our policy to deny payment of the O/O E/M visit
complexity add-on code when the O/O E/M base code is reported on the
same day as a preventive immunization or other Medicare preventive
service is disruptive to the way such care is usually furnished.
However, we do agree with practitioners expressing concerns that the
current policy is not well-aligned with our policy objective for
establishing the add-on payment.
In response to these concerns, we are proposing to refine our
current policy for services furnished beginning in CY 2025. We are
proposing to allow payment of the O/O E/M visit complexity add-on code
when the O/O E/M base code is reported by the same practitioner on the
same day as an AWV, vaccine administration, or any Medicare Part B
preventive service furnished in the office or outpatient setting.
Allowing payment for the O/O E/M visit complexity add-on code in this
scenario as proposed would support our policy aims, which include
paying for previously unaccounted resources inherent in the complexity
of all longitudinal primary care office visits. In part, the O/O E/M
visit complexity add-on code recognizes the inherent costs of building
trust in the practitioner-patient relationship. We believe that trust-
building in the longitudinal relationship is more significant than ever
in making decisions about the administration of immunizations and other
Medicare Part B preventive services. We welcome comments on this
proposal.
G. Enhanced Care Management
1. Background
The CMS Center for Medicare and Medicaid Innovation (CMS Innovation
Center) tests innovative payment and service delivery models to reduce
program expenditures while preserving or enhancing quality of care. CMS
Innovation Center models are assessed for their impact on quality of
care and expenditures under Medicare, Medicaid, and the Children's
Health Insurance Program (CHIP) and the scope and duration of the model
test may be expanded through rulemaking if expected to either reduce
spending without compromising quality of care or enhance quality of
care without increasing spending (section 1115A of the Act). After more
than a decade of testing over 50 innovative payment and service
delivery models, the CMS Innovation Center has enabled broad
transformative changes to service delivery and payment in the Medicare,
Medicaid, and CHIP programs which inspire additional transformation
throughout the health care delivery system. Participants in CMS
Innovation Center models have demonstrated improvements in care
delivery and patient experience. The CMS Innovation Center undertook a
retrospective review and synthesis of select model evaluations where
care delivery changes have been observed, and the review indicated
demonstrable evidence of enhanced care delivery in several areas, such
as care coordination, team-based care, and leveraging data to risk-
stratify patients.\21\
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\21\ Fowler, Ph.D., JD, E., Rudolph, MPH, N., Davidson, LCSW,
MSW, K., Finke, MD, B., Flood, S., Bernheim, MD, Ph.D., S. M., &
Rawal, Ph.D., P. (2023). Accelerating Care Delivery Transformation--
The CMS Innovation Center's Role in the Next Decade. New England
Journal of Medicine, 4(11). https://doi.org/10.1056/cat.23.0228.
CMS. Synthesis of Evaluation Results across 21 Medicare Models,
2012-2020. Fowler, Ph.D. 2022. https://www.cms.gov/priorities/innovation/data-and-reports/2022/wp-eval-synthesis-21models.
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Under the Medicare Physician Fee Schedule (PFS) statute at section
1848 of the Act, we establish payment
[[Page 61698]]
amounts for covered physicians' services, and update our payment
policies to address changes, including changes in medical practice. In
this proposed rule, we are proposing to incorporate key payment and
service delivery elements from CMS Innovation Center models tested and
evaluated over the prior decade into permanent coding and payment under
the PFS. Specifically, we are proposing to recognize a primary care
practice delivery model trend which we will refer to as ``advanced
primary care'' and which we propose to define using the 2021 National
Academies of Sciences, Engineering, and Medicine (NASEM) report on
Implementing High-Quality Care as: ``whole-person, integrated,
accessible, and equitable health care by interprofessional teams that
are accountable for addressing the majority of an individual's health
and wellness needs across settings and through sustained relationships
with patients, families, and communities.'' \22\ Using this definition,
we are proposing to recognize the resources involved in furnishing
services using an ``advanced primary care'' approach to care under the
PFS.\23\ Under this approach, the delivery of care is supported by a
team-based care structure and involves a restructuring of the primary
care team, which includes the billing practitioner and the auxiliary
personnel under their general supervision, within practices. This
restructuring creates several advantages for patients, and provides
more broad accessibility and alternative methods for patients to
communicate with their care team/practitioner about their care outside
of in-person visits (for example, virtual, asynchronous interactions,
such as online chat), which can lead to more timely and efficient
identification of, and responses to, health care needs (for example,
practitioners can route patients to the optimal clinician and setting--
to a synchronous visit, an asynchronous chat, or a direct referral to
the optimal site of care).\24\ Practitioners using an advanced primary
care delivery model can more easily collaborate across clinical
disciplines through remote interprofessional consultations with
specialists as well as standardize condition management into evidence-
based clinical workflows, which allow for closed-loop follow-up and
more real-time management for patients with acute or evolving complex
issues. Practitioners can then use synchronous interactions to build
rapport with patients and families, partner on complex decisions, and
personalize their patients' care plans.
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\22\ National Academies of Sciences, Engineering, and Medicine.
2021. Implementing high-quality primary care: Rebuilding the
foundation of health care. Washington, DC: The National Academies
Press. https://doi.org/10.17226/25983.
\23\ Team-based approaches to care can achieve improved provider
and care team satisfaction, improved team communication, improved
patient safety, and improved patient and family engagement in care.
Coleman, M. Dexter. D., & Nankivill, N. (2015, August). Factors
affecting physician satisfaction and Wisconsin Medical Society
strategies to drive change. Wisconsin Medical Journal. 114(4), 135-
142. Retrieved from https://www.wisconsinmedicalsociety.org/professional/wmj/archives/volume-114-issue-4-august-2015/.
\24\ Ellner, A., Basu, N. & Phillips, R.S. From Revolution to
Evolution: Early Experience with Virtual-First, Outcomes-Based
Primary Care. J GEN INTERN MED 38, 1975-1979 (2023). https://doi.org/10.1007/s11606-023-08151-1.
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Specifically, we are proposing to adopt coding and payment policies
to recognize advanced primary care management (APCM) services for use
by practitioners who are providing services under this specific model
of advanced primary care, when the practitioner is the continuing focal
point for all needed health care services and responsible for all
primary care services. This new proposed coding and payment makes use
of lessons learned from the CMS Innovation Center's testing of a series
of advanced primary care models, such as Comprehensive Primary Care
(CPC),\25\ Comprehensive Primary Care Plus (CPC+),\26\ and Primary Care
First (PCF) 27 28 (see discussion in section II.G.2.a.(1) in
this proposed rule) to inform the elements upon which the delivery of
APCM services under an advanced primary care delivery model depend. As
detailed below in sections II.G.2.b. through II.G.2.d., this proposed
coding and payment will incorporate elements of several specific,
existing care management and communication technology-based services
(CTBS) into a bundle of services, that reflects the essential elements
of the delivery of advanced primary care, for payment under the PFS
starting in 2025.
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\25\ https://www.cms.gov/priorities/innovation/innovation-models/comprehensive-primary-care-initiative.
\26\ https://www.cms.gov/priorities/innovation/innovation-models/comprehensive-primary-care-plus.
\27\ https://www.cms.gov/priorities/innovation/innovation-models/primary-care-first-model-options.
\28\ Finke, Bruce, et al. ``Addressing Challenges in Primary
Care--Lessons to Guide Innovation.'' JAMA Health Forum, vol. 3, no.
8, 19 Aug. 2022, p. e222690, https://doi.org/10.1001/jamahealthforum.2022.2690.
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In the context of the proposal, we are also interested in feedback
on other related policies for our consideration in future rulemaking.
To gather information from interested parties to inform potential
future proposals, we have included an Advanced Primary Care Hybrid
Payment Request for Information (RFI) (Advanced Primary Care RFI) in
this proposed rule. The Advanced Primary Care RFI seeks feedback on
whether and how we should consider additional payment policies that
reflect our efforts to recognize the delivery of advanced primary care,
including bundling of additional individual services, which may
currently be furnished together as primary care services but paid
separately. This focused approach to seeking feedback on advanced
primary care payment policies is an important step in our ongoing
efforts to emphasize accountable care and supports CMS' goal of having
100 percent of Traditional Medicare beneficiaries in accountable care
relationships by 2030.\29\
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\29\ CMS White Paper on CMS Innovation Center's Strategy:
Driving Health System Transformation--A Strategy for the CMS
Innovation Center's Second Decade (https://www.cms.gov/priorities/innovation/strategic-direction-whitepaper).
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In addition to recognizing advanced primary care, this proposed
rule also recognizes physician and practitioner work that draws from
evidence generated by the CMS Innovation Center's Million
Hearts[supreg] model.\30\ The Million Hearts[supreg] model found that
quantitative assessment of patients' atherosclerotic cardiovascular
disease (ASCVD) risk and providing high-risk beneficiaries with
cardiovascular-focused care management services improved quality of
care, including mortality.\31\ We discuss a proposal in this section to
establish coding and PFS payment for these services based in part on
the evidence generated by the Million Hearts[supreg] model.
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\30\ https://www.cms.gov/priorities/innovation/innovation-models/million-hearts-cvdrrm.
\31\ Peterson G, Steiner A, Powell R, et al. Evaluation of the
Million Hearts[supreg] Cardiovascular Disease Risk Reduction Model:
Fourth Annual Report. Mathematica. February 2022. https://www.cms.gov/priorities/innovation/data-and-reports/2022/mhcvdrrm-fourthannevalrpt.
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2. Advanced Primary Care Management (APCM) Services (HCPCS Codes GPCM1,
GPCM2, and GPCM3)
a. Background
We have been analyzing opportunities to strengthen and invest in
primary care in alignment with the goals of the U.S. Department of
Health and Human Services (HHS) Initiative to Strengthen Primary
Care.\32\ Research has
[[Page 61699]]
demonstrated that greater primary care physician supply is associated
with improved population-level mortality and reduced disparities,\33\
and also, that establishing a long-term relationship with a primary
care provider leads to reduced emergency department (ED) visits,\34\
improved care coordination, and increased patient satisfaction.\35\ HHS
recognizes that effective primary care is essential for improving
access to healthcare, for the health and wellbeing of individuals,
families, and communities, and for achieving health equity. The first
coordinated set of HHS-wide actions to strengthen primary care, as part
of the Initiative, is in primary care payment; for example, adjusting
payment to ensure it supports delivery of advanced primary care. CMS
Innovation Center models, described in section II.G.2.a.(1) in this
proposed rule, reflect the ongoing work within HHS and the unified,
comprehensive approach to HHS primary care activities that we are
accomplishing through our current statutory authorities and funding.
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\32\ U.S. Department of Health and Human Services. (2023).
Primary Care: Our First Line of Defense. https://www.hhs.gov/sites/default/files/primary-care-issue-brief.pdf.
\33\ Basu S, Berkowitz SA, Phillips RL, Bitton A, Landon BE,
Phillips RS. Association of Primary Care Physician Supply With
Population Mortality in the United States, 2005-2015. JAMA Intern
Med. 2019;179(4):506-514. doi:10.1001/jamainternmed.2018.7624.
https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2724393.
\34\ Willemijn L.A. Sch[auml]fer et al, ``Are People's Health
Care Needs Better Met When Primary Care Is Strong? A Synthesis of
the Results of the QUALICOPC Study in 34 Countries,'' Primary Health
Care Research and Development 20 (2019): e104. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6609545/.
\35\ Michael J. van den Berg, Tessa van Loenen, and Gert P
Westert, ``Accessible and Continuous Primary Care May Help Reduce
Rates of Emergency Department Use: An International Survey in 34
Countries,'' Family Practice 33, no. 1 (Feb. 2016): 42-50. https://academic.oup.com/fampra/article/33/1/42/2450446.
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Over the last decade, we have updated PFS payment policies as
appropriate, and we remain committed to improving how Medicare payment
recognizes the resources involved in furnishing covered services that
encompass aspects of advanced primary care furnished by
interprofessional care teams and typically concentrating on the
delivery of appropriate preventive care to patients and the management
of individuals' chronic conditions as they progress over time. As part
of the CY 2014 PFS final rule, we reaffirmed our support of primary
care and recognized care management as one of the critical components
of primary care that contributes to better health outcomes for
individuals and reduced expenditure growth, and explained our
prioritization of the development and implementation of several
initiatives (such as those discussed in section II.G.2.a.(1) in this
proposed rule) (77 FR 68978). Since then, we have implemented coding
and payment for many care management services to better recognize the
resources involved in furnishing medically necessary care management
activities that generally are performed outside the context of a face-
to-face, in-person visit--most often by the billing practitioner's
clinical staff on behalf of patients with complex health care needs,
including transitional care management in the CY 2013 PFS final rule
(77 FR 68979); non-complex and complex chronic care management (CCM) in
the CY 2015, 2017, and 2019 PFS final rules (78 FR 74414, 83 FR 58577,
and 81 FR 80244); and principal care management (PCM) in the CY 2020
PFS final rule (84 FR 62962). The CCM and PCM code families now include
5 sets of codes which are reported monthly on a timed basis, each set
with a base code of 20 to 60 minutes and an add-on code for each
additional 30 minutes. The code sets vary by the degree of complexity
of patient conditions (that is, non-complex and complex CCM for
multiple chronic conditions or PCM for a single high-risk condition),
and whether the number of minutes spent by clinical staff or the
physician or non-physician practitioner (NPP) is used to meet time
thresholds for billing.
Additionally, we have established coding and payment for certain
services where a medical professional evaluates a patient's medical
information remotely using communication technology. As discussed in
the CY 2019 PFS final rule, this set of services is defined by and
inherently involves the use of communications technology, and includes
certain remote patient monitoring services, virtual check-in services,
remote evaluation of pre-recorded patient information, remote
interpretations of diagnostic imaging tests, and interprofessional
consultations. We recognize that technological advances have changed
and continue to change the practitioner-patient care delivery
interaction. We have recognized these technology-enabled interactions
through separately billable CTBS over the last several years. However,
we acknowledge, as we learn more about how advanced primary care
services are furnished to patients, that in some clinical care delivery
scenarios, practitioners furnishing the type of care highlighted in
this discussion may furnish certain aspects of the CTBS services in
complement to care management services (for example, by allowing
interprofessional care teams to answer patient questions, refer
patients to higher levels of care, view and interpret patient images,
order needed treatments, and offer reassurance or advice), in an effort
to more efficiently manage the quantity and quality of medical
information that is necessary to support effective patient-centered
treatment plans.
Despite these important steps to pay separately for these care
management services, there has been limited uptake of care management
services and Medicare still overwhelmingly pays for primary care
through traditional office/outpatient (O/O) Evaluation and Management
(E/M) visit codes, which describe a broad range of physicians' services
but do not fully distinguish and account for the resources associated
with primary care and other longitudinal care. As we stated in the CY
2024 PFS final rule, we believe that because E/M visit codes are
intended to be used very broadly, the complexity of services required
to provide this type of care is not fully incorporated as part of the
valuation of the work RVUs when the E/M code itself is used as the
primary way to report the work of the professional (88 FR 78972). In
the CY 2024 PFS final rule, we took steps to better recognize the
inherent complexity of visits associated with primary and longitudinal
care of patients by finalizing a new add-on code (HCPCS code G2211) for
use by practitioners furnishing services as the continuing focal point
for all the patient's needed health care services, such as a primary
care practitioner (88 FR 78969). When furnishing primary and
longitudinal care, practitioners must be attuned to the factors that
develop and maintain trusting practitioner-patient relationships that
enable effective diagnosis, management, and treatment on an ongoing
basis. In finalizing the O/O E/M visit complexity add-on code, we
recognized the feedback from interested parties indicating that the
care management codes alone may not have mitigated the deficiencies in
the ability of existing E/M codes to reflect the time and resources
involved in furnishing visits in the context of longitudinal care--of
which, advanced primary care is one model. Many commenters responded,
as reflected in the CY 2024 PFS final rule, that they did not view the
coding and payment currently available under the PFS as capable of
recognizing the broad range of elements that define primary care (88 FR
52326). Other commenters responded that they did not believe that the
existing E/M service codes alone reflect the work and resources
involved in furnishing non-
[[Page 61700]]
procedural care to Medicare beneficiaries (88 FR 78976).
Over the years, interested parties have focused attention on the
ongoing need to improve how practitioners are paid, in and outside of
payment bundles, including but not limited to the possibility of E/M
codes designed specifically to be billed in conjunction with care
management codes and the elimination of multiple disparities between
the payment for E/M services in global periods and those furnished
individually. Based on feedback from the physician and practitioner
community, we understand that advanced primary care encompasses the
work of interprofessional teams who are accountable for addressing the
majority of an individual's health and wellness needs across settings
and through sustained relationships, which necessarily involves time
spent by primary care practitioners and their clinical staff outside of
individual E/M visits.
As with many services paid under the PFS, we balance making payment
that recognizes and supports technological developments in healthcare
and the resources involved in evolving medical practice to allow for
appropriate and expanded access to innovative technologies and newer
services with promoting stability and efficiency in coding and billing
rules for practitioners and institutions. We recognize the important
role of gathering input and information from the CMS Innovation Center
models (described in more detail in section II.G.2.a.(1) in this
proposed rule), comment solicitations, research from other public and
private entities, the work of all parties involved in furnishing
primary care, and from the public at large. As previously noted,
interested parties have given ample feedback over the years to inform
our recognition of care management services; for example, as part of
the CY 2022 PFS rulemaking, interested parties specifically requested
our consideration of a ``30-day global period bundling care management
services'' and we responded that we would consider this suggestion for
future rulemaking (86 FR 65118). We have continued to incorporate
feedback into our rulemaking and strengthen our care management code
sets with the goal of better recognizing the elements of advanced
primary care as part of a multi-year strategy. Based on this feedback,
we are proposing to establish a set of codes to better describe
advanced primary care management services broadly, to provide more
stability in payment and coding for practitioners in the context of
continued evolution in advanced primary care, as well as to provide us
with a mechanism for continued and intentional improvements to advanced
primary care payment.
(1) Key Care Delivery Methods in Select CMS Innovation Center Models
We have prioritized the implementation or testing of a series of
initiatives designed to improve payment for, and encourage long-term
investment in, primary care and care management services. By supporting
enhanced care management and coordination, these initiatives
contributed to the growing practice of advanced primary care and have
also provided valuable lessons learned that we are incorporating into
our proposals.
Several CMS Innovation Center models address payment for care
management services and CTBS. The CPC initiative,\36\ the CPC+
model,\37\ and the PCF model \38\ all included payments for care
management services that closely aligned with the care management
services included in the PFS. In these initiatives, primary care
practices received risk-adjusted, per beneficiary per month (PBPM)
payments for care management services furnished to Medicare FFS
beneficiaries attributed to their practices. These model payments were
designed to offer practices a stable, predictable revenue stream that
supported required infrastructure and appropriately compensated
practices for the enhanced services they would provide. Practices
participating in CPC+ consistently cited these payments as the most
useful type of model payment support they received; these stable,
prospectively paid payments typically served as the main funding source
for compensating care managers, behavioral health providers, and other
staff hired to improve care delivery.\39\ Because these payments were
paid prospectively and could be used to support a range of care
management and coordination activities, they provided participants with
greater financial stability and flexibility to develop and expand
capabilities to meet patients' care needs.\40\ Table 19 identifies a
number of CMS Innovation Center models and key care delivery methods
from each.\41\
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\36\ https://downloads.cms.gov/files/cmmi/CPC-initiative-fourth-annual-report.pdf.
\37\ https://www.cms.gov/priorities/innovation/data-and-reports/2023/cpc-plus-fifth-annual-eval-report.
\38\ Evaluation of the Primary Care First Model. February 2024.
https://www.cms.gov/priorities/innovation/data-and-reports/2024/pcf-second-eval-rpt.
\39\ O'Malley A, Singh P, Fu N, et al. Independent Evaluation of
the Comprehensive Primary Care Plus (CPC+): Final Report.
Mathematica. December 2023. https://www.cms.gov/priorities/innovation/data-and-reports/2023/cpc-plus-fifth-annual-eval-report.
\40\ O'Malley A, Singh P, Fu N, et al. Independent Evaluation of
the Comprehensive Primary Care Plus (CPC+): Final Report.
Mathematica. December 2023. https://www.cms.gov/priorities/innovation/data-and-reports/2023/cpc-plus-fifth-annual-eval-report.
\41\ For more information on how the Innovation Center is
supporting primary care, https://www.cms.gov/files/document/primary-care-infographic.pdf.
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BILLING CODE P
[[Page 61701]]
[GRAPHIC] [TIFF OMITTED] TP31JY24.041
[[Page 61702]]
[GRAPHIC] [TIFF OMITTED] TP31JY24.042
BILLING CODE C
b. Proposed HCPCS G-Codes for Advanced Primary Care Management (APCM)
We are proposing to establish coding and make payment under the PFS
for a newly defined set of APCM services described and defined by three
new HCPCS G-codes. To recognize the resource costs associated with
furnishing APCM services to Medicare beneficiaries, we are proposing to
establish and pay for three new G-codes that describe a set of care
management services and CTBS furnished under a broader application of
advanced primary care. This new coding and payment would reflect the
recognized effectiveness and growing adoption of the advanced primary
care approach to care.\42\ It would also encompass a broader range of
services and simplify the billing and documentation requirements, as
compared to existing care management and CTBS codes, for clinicians who
care for their patients using an advanced primary care model. We
recognize that there are primary care physicians, practitioners, and
practices beyond those that have participated in CMS Innovation Center
primary care models (such as those discussed in section II.G.2.a.(1) in
this proposed rule), that may incur resource costs associated with
their treatment of patients based on the advanced primary care delivery
model. Providing care using an advanced primary care delivery model
involves resource costs associated with maintaining certain practice
capabilities and continuous readiness and monitoring activities to
support a team-based approach to care, where significant resources are
used on virtual, asynchronous patient interactions, collaboration
across clinical disciplines, and real-time management of patients with
acute and complex concerns, that are not fully recognized or paid for
by the existing care management codes. We have observed medical
practice trends in primary care for several years. We note that in
prior rulemaking, for example, in the CY 2013 PFS final rule, we
stated, ``we further consider[ed] how advanced primary care practices
can fit within a fee-for-service model'' (77 FR 68987), and in the CY
2015 PFS final rule, we stated our commitment ``to supporting advanced
primary care, including the recognition of care management as one of
the critical components of primary care that contributes to better
health for individuals and reduced expenditure growth'' (79 FR 67715).
In the CY 2017 PFS final rule, we discussed changes to retain elements
of the CCM service that are ``most characteristic of the changes in
medical practice toward advanced primary care'' (81 FR 80251). As the
delivery of primary care has evolved to embrace advanced primary care
more fully, we believe that it is prudent to now adopt specific coding
and payment policy to better recognize the resources involved in care
management under an advanced primary care delivery model.
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\42\ National Academies of Sciences, Engineering, and Medicine
(NASEM). 2021. Implementing high-quality primary care: Rebuilding
the foundation of health care. Washington, DC: The National
Academies Press. https://doi.org/10.17226/25983.; Maeng DD et al.
Reducing long-term cost by transforming primary care: evidence from
Geisinger's medical home model. Am J Manag Care. 2012 Mar;18(3):149-
55. PMID: 22435908. Available here: https://pubmed.ncbi.nlm.nih.gov/22435908.;/ Jones C et al. Vermont's Community-Oriented All-Payer
Medical Home Model Reduces Expenditures and Utilization While
Delivering High-Quality Care. Popul Health Manag. 2016;19(3):196-
205. Available here: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4913508/.
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Below, we explain the proposed new codes and their descriptors. In
the next section, we propose to define the elements of the scope of
service for APCM that would be required for a practitioner to bill
Medicare for the APCM service, and we explain the proposed standards
for practices that furnish APCM services to ensure that the physicians
and practitioners who bill for these services have the capability to
fully furnish advanced primary care, including APCM services (see
section II.G.2.c. of this proposed rule). At this time, we are
proposing to identify specific care management and CTBS services that
are a part of advanced primary care delivery and would be bundled into
the PFS payment for the APCM services. As such, we will identify the
services that we are proposing would overlap substantially with the new
codes and which would not be separately billable with the APCM codes
under our proposal (see section II.G.2.d. of this proposed rule).
Finally, we propose to establish relative values for these codes for
purposes of payment under the PFS (see section II.G.2.e. of this
proposed rule).
We are proposing to establish the following G-codes and descriptors
for APCM services, and as explained in the next section, due to the
similar scope of APCM and other care management and CTBS services, we
are proposing to include some of the same language from the CCM and PCM
service elements in the APCM code descriptors, as well as emphasize
that certain practice capabilities and requirements are inherent in
these elements and must be met in order to bill for APCM services:
HCPCS code GPCM1 (Advanced primary care management services
provided by clinical staff and directed by a physician or other
qualified health care professional who is responsible for all primary
care and serves as the continuing focal point for all needed health
care services, per calendar
[[Page 61703]]
month, with the following elements, as appropriate:
Consent;
++ Inform the patient of the availability of the service; that only
one practitioner can furnish and be paid for the service during a
calendar month; of the right to stop the services at any time
(effective at the end of the calendar month); and that cost sharing may
apply.
++ Document in patient's medical record that consent was obtained.
Initiation during a qualifying visit for new patients or
patients not seen within 3 years;
Provide 24/7 access for urgent needs to care team/
practitioner, including providing patients/caregivers with a way to
contact health care professionals in the practice to discuss urgent
needs regardless of the time of day or day of week;
Continuity of care with a designated member of the care
team with whom the patient is able to schedule successive routine
appointments;
Deliver care in alternative ways to traditional office
visits to best meet the patient's needs, such as home visits and/or
expanded hours;
Overall comprehensive care management;
++ Systematic needs assessment (medical and psychosocial).
++ System-based approaches to ensure receipt of preventive
services.
++ Medication reconciliation, management and oversight of self-
management.
Development, implementation, revision, and maintenance of
an electronic patient-centered comprehensive care plan;
++ Care plan is available timely within and outside the billing
practice as appropriate to individuals involved in the beneficiary's
care, can be routinely accessed and updated by care team/practitioner,
and copy of care plan to patient/caregiver;
Coordination of care transitions between and among health
care providers and settings, including referrals to other clinicians
and follow-up after an emergency department visit and discharges from
hospitals, skilled nursing facilities or other health care facilities
as applicable;
++ Ensure timely exchange of electronic health information with
other practitioners and providers to support continuity of care.
++ Ensure timely follow-up communication (direct contact,
telephone, electronic) with the patient and/or caregiver after an
emergency department visit and discharges from hospitals, skilled
nursing facilities, or other health care facilities, within 7 calendar
days of discharge, as clinically indicated.
Ongoing communication and coordinating receipt of needed
services from practitioners, home- and community-based service
providers, community-based social service providers, hospitals, and
skilled nursing facilities (or other health care facilities), and
document communication regarding the patient's psychosocial strengths
and needs, functional deficits, goals, preferences, and desired
outcomes, including cultural and linguistic factors, in the patient's
medical record;
Enhanced opportunities for the beneficiary and any
caregiver to communicate with the care team/practitioner regarding the
beneficiary's care through the use of asynchronous non-face-to-face
consultation methods other than telephone, such as secure messaging,
email, internet, or patient portal, and other communication-technology
based services, including remote evaluation of pre-recorded patient
information and interprofessional telephone/internet/EHR referral
service(s), to maintain ongoing communication with patients, as
appropriate;
++ Ensure access to patient-initiated digital communications that
require a clinical decision, such as virtual check-ins and digital
online assessment and management and E/M visits (or e-visits).
Analyze patient population data to identify gaps in care
and offer additional interventions, as appropriate;
Risk stratify the practice population based on defined
diagnoses, claims, or other electronic data to identify and target
services to patients;
Be assessed through performance measurement of primary
care quality, total cost of care, and meaningful use of Certified EHR
Technology.).
HCPCS code GPCM2 (Advanced primary care management services for a
patient with multiple (two or more) chronic conditions expected to last
at least 12 months, or until the death of the patient, which place the
patient at significant risk of death, acute exacerbation/
decompensation, or functional decline, provided by clinical staff and
directed by a physician or other qualified health care professional who
is responsible for all primary care and serves as the continuing focal
point for all needed health care services, per calendar month, with the
elements included in GPCM1, as appropriate) and HCPCS code GPCM3
(Advanced primary care management services for a patient that is a
Qualified Medicare Beneficiary with multiple (two or more) chronic
conditions expected to last at least 12 months, or until the death of
the patient, which place the patient at significant risk of death,
acute exacerbation/decompensation, or functional decline, provided by
clinical staff and directed by a physician or other qualified health
care professional who is responsible for all primary care and serves as
the continuing focal point for all needed health care services, per
calendar month, with the elements included in GPCM1, as appropriate).
HCPCS codes GPCM1 through GPCM3 would describe APCM services
furnished per calendar month, following the initial qualifying visit
(see section II.G.2.c.(1) for more on the initiating visit). Physicians
and NPPs, including nurse practitioners (NPs), physician assistants
(PAs), certified nurse midwives (CNMs) and clinical nurse specialists
(CNSs), could bill for APCM services. As we will describe in more
detail in section II.G.2.c., within the code descriptors for GPCM1,
GPCM2, and GPCM3, we are including the elements of the scope of service
for APCM as well as the practice capabilities and requirements that we
believe to be inherent to care delivery by the care team/practitioner
who is billing under a practice using an advanced primary care delivery
model, and necessary to fully furnish and, therefore, bill for APCM
services.
As described in more detail below, within the code descriptors for
GPCM1, GPCM2, and GPCM3, we are proposing that the practitioner who
bills for APCM services intends to be responsible for the patient's
primary care and serves as the continuing focal point for all needed
health care services. We anticipate that most practitioners furnishing
APCM services will be managing all the patient's health care services
over the month and have either already been providing ongoing care for
the beneficiary or have the intention of being responsible for the
patient's primary care and serving as the continuing focal point for
all the patient's health care services. We anticipate that these codes
will mostly be used by the primary care specialties, such as general
medicine, geriatric medicine, family medicine, internal medicine, and
pediatrics, but we are also aware that, in some instances, certain
specialists function as primary care practitioners--for example, an OB/
GYN or a cardiologist. In contrast to situations where the patient's
overall, ongoing care is being managed, monitored, and/or observed by a
practitioner, we believe that there are situations when care is
provided by a practitioner who would not serve as
[[Page 61704]]
``the continuing focal point for all needed health care services.''
Similarly, there are some time- or condition-limited practitioner-
patient relationships that are clearly not indicative of the ongoing
care that we anticipate practitioners would be responsible for when
furnishing APCM services. As we stated in the CY 2021 PFS proposed rule
and CY 2024 PFS final rule in the context of our policies for the O/O
E/M visit complexity add-on code (HCPCS code G2211), a practitioner
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 of 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, 88 FR
78971). For example, a patient who spends one month of the year in
another location could require physicians' services in that location if
they experience exacerbation of one of their chronic conditions, but
the practitioner who treats them would not intend to manage or monitor
that patient's overall, ongoing care. Finally, HCPCS code G2211 can
also be billed when medical services are ``part of ongoing care related
to a patient's single, serious condition or complex condition,'' but
this is different from the APCM requirement. A practitioner's
management of one or more serious conditions (as is often the case with
specialty care), without more, does not mean that the practitioner is
also responsible for all primary care services and the focal point for
all needed care (the requirement for APCM), and thus would not
necessarily mean that the practitioner could bill for APCM.
As is our current policy for other care management services, and
consistent with both CPT guidance and Medicare rules for CPT codes
99487, 99489, 99490, we are proposing that HCPCS codes GPCM1, GPCM2,
and GPCM3 may only be reported once per service period (calendar month)
and only by the single practitioner who assumes the care management
role with a particular beneficiary for the service period. That is,
based on a patient's status, a physician or practitioner would identify
the patient to receive Level 1, Level 2, or Level 3 APCM services
during a given service period (calendar month), and we would make
payment for only one claim for APCM services for that service period.
At this time, we do not see the need or value of proposing restrictions
or complex operational mechanisms to identify a single physician or NPP
who may bill for APCM services for a specific beneficiary. However, we
recognize that other initiatives, such as the Medicare Shared Savings
program, have operational mechanisms in place to attribute patients to
certain ACOs (Sec. 425.400). While a similar approach could be used to
attribute patients for APCM services, we are reluctant to introduce
unnecessary complexity for these services. As we continue to develop
our policies in this area, we are seeking feedback from interested
parties on methodologies that could allow for identification of the
beneficiary's primary care practitioner. We are also seeking comment on
whether there should be additional requirements to prevent potential
care fragmentation or service duplication.
We anticipate that APCM services would ordinarily be provided by
clinical staff incident to the professional services of the billing
practitioner in accordance with our regulation at Sec. 410.26. We are
proposing that APCM services would be considered a ``designated care
management service'' under Sec. 410.26(b)(5) and, as such, could be
provided by auxiliary personnel under the general supervision of the
billing practitioner.
Unlike the current coding to describe care management services, we
are further proposing that the code descriptors for GPCM1, GPCM2, and
GPCM3 would not be time-based. Based on feedback from the physician and
practitioner community, we understand that ongoing care management and
coordination services are standard parts of advanced primary care, even
in months when documented clinical staff or billing professional
minutes may not reach the required thresholds for billing or the
patient's condition does not meet the clinical conditions for care
management services under the existing code set. In consideration of
the extensive feedback from interested parties, we have learned that
practitioners who currently furnish monthly care management services
may already be providing APCM services in a variety of clinical
circumstances, documenting all necessary aspects of the patient-
centered care furnished monthly to the patient without meeting the
requirements to bill for care management services, such as satisfying
the administrative requirement to count clinical staff minutes to reach
specific time-based thresholds. As we stated in the CY 2024 PFS final
rule in the context of the O/O E/M visit complexity add-on code (HCPCS
code G2211), primary care physicians may diagnose and treat a condition
in an O/O E/M visit that is not expected to last as long as three
months or would not reasonably be expected to result in a risk of
hospitalization, and the practitioner's clinical staff may provide
significant care management and coordination services relating to that
condition. For example, COVID-19 cases are clinical circumstances that
generally do not last three months but may require significant acute
management, care coordination, and follow-up within a given month,
particularly for patients with comorbidities (88 FR 78973).
Practitioners may also provide care management and coordination
services to a patient whose condition meets the criteria in one or more
care management codes, but the documented minutes of service may not
reach the minimum time threshold to bill for a care management service.
For example, the practitioner might provide care coordination for a
month that includes 20 minutes of consulting with the patient's other
healthcare providers and modifying medications to address an acute
exacerbation of hypertension, but would not meet the requirements for
billing the PCM service. We also note that, unlike the current coding
to describe certain CTBS services, we are proposing that the code
descriptors for GPCM1, GPCM2, and GPCM3 would not include the timeframe
restrictions for billing certain CTBS (for example, the restriction for
virtual check-in services that there is not a related E/M service
provided within the previous 7 days or an E/M service or procedure
within the next 24 hours or the soonest available appointment). As
addressed in the CY2019 Final Rule, we have heard from interested
parties that the timeframe restrictions for billing certain CTBS are
administratively burdensome (83 FR 59686).
We are also proposing that not all elements included in the code
descriptors for APCM services must be furnished during any given
calendar month for which the service is billed. APCM services are
largely designed to be person-centered and focused on the individual
patient, such that the elements that are provided depend on medical
necessity and individual patient need. Therefore, we anticipate that
all the APCM scope of service
[[Page 61705]]
elements (for example, comprehensive care management and care
coordination) will be routinely provided, as deemed appropriate for
each patient, acknowledging that not all elements may be necessary for
every patient during each month (for example, the beneficiary may have
no hospital admissions that month, so there is no management of a care
transition after hospital discharge). We also anticipate that there may
be some months where it may be appropriate for some service elements to
be performed more than once for the patient. For example, in one month
a patient with heart failure and chronic kidney disease receiving APCM
Level 2 services (GPCM2) may be on a stable medication regimen, receive
communication about their care plan, but no virtual check-ins. The next
month, the patient may experience a heart failure exacerbation
requiring inpatient admission, and then receive as part of their APCM
service timely communication and follow-up with new labs ordered,
multiple virtual check-ins ensuring that the patient understands their
new medications, a phone call to help the patient understand the lab
results, and an interprofessional consultation with the patient's
cardiologist to help decide if the patient's diuretic dosage should be
changed.
However, even if not all elements of the APCM service are furnished
each month for which APCM is billed, we propose that billing
practitioners and auxiliary personnel must have the ability to furnish
every service element and furnish these elements as is appropriate for
any individual patient during any calendar month. As described in more
detail in section II.G.2.c. of this proposed rule, we believe that
maintaining certain advanced primary care practice capabilities and
requirements is inherent in these elements and must be met to fully
furnish and bill APCM. For example, if in our previous example, the
patient with heart failure and chronic kidney disease receiving Level 2
APCM experiences swollen legs, the patient should be able to submit a
photo or video to the practitioner via a secure communications system,
and the practitioner must be able to interpret and communicate remotely
with the patient about those images.
While we are proposing that specific minutes spent furnishing APCM
services for purposes of billing HCPCS codes GPCM1-GPCM3 need not be
documented in the patient's medical record, we would expect that any
actions or communications that fall within the APCM elements of service
would be described in the medical record and, as appropriate, its
relationship to the clinical problem(s) they are intended to resolve
and the treatment plan, just as all clinical care is documented in the
medical record.
We are seeking feedback on these service descriptions, and on
whether there are elements of other care management services that
should be removed or altered for purposes of APCM services.
Finally, while the service descriptors above are consistent across
all three APCM levels because the scope of service elements are
consistent across all levels of APCM and the elements that are provided
depend on medical necessity and individual patient need, we are
proposing that the APCM codes would be stratified into three levels
based on certain patient characteristics that are broadly indicative of
patient complexity and the consequent resource intensity involved in
the provision of these services in the context of advanced primary
care. We are proposing that the new APCM coding schema would be
stratified based on APCM services being furnished using the advanced
primary care model to patients with one or fewer chronic conditions
(``Level 1''); patients with two or more chronic conditions (``Level
2''); and Qualified Medicare Beneficiaries (QMBs) \43\ with two or more
chronic conditions (``Level 3'') (see Table 20 for the three APCM code
levels). This stratification of APCM into three levels allows us to
distinguish among different levels of patient complexity and more
accurately reflect the resources required to furnish APCM services for
certain categories of beneficiaries. We anticipate that a practitioner
using the advanced primary care model would bill for APCM services for
all or nearly all the patients for whom they intend to assume
responsibility for primary care.
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\43\ See 42 CFR 435.123. The proposal includes both individuals
in the QMB eligibility group who also have full scope Medicaid
coverage (``QMB-plus'') and individuals in the QMB eligibility group
who do not have Medicaid eligibility under any other Medicaid
coverage group (``QMB-only''). However, this proposal would not
include those QMBs who are in the Medicare Part B Immunosuppressive
Drug benefit, which provides coverage of immunosuppressive drugs
based on eligibility requirements described in Sec. 407.55, because
such individuals would not qualify for Medicare coverage of the
services described in this rulemaking. See 42 CFR 435.123(c)(2).
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Furthermore, we recognize the ways in which this new APCM coding
intersects with current care management codes around number of chronic
conditions. We note that the current care management codes are
generally stratified in a similar, though more granular way, by the
degree of complexity of care based on the presence of chronic
conditions and complexity of medical decision making, who directly
performs the service, and the time spent furnishing the service. In
establishing separate payment for CCM services in the CY 2014 PFS final
rule, we recognized that the resources involved in furnishing
comprehensive, coordinated care management services to patients with
multiple (two or more) chronic conditions were greater than those
included in a typical non-face-to-face care management service, which
we continued to consider as bundled into the payment for face-to-face
E/M visits (78 FR 43337). In the CY 2017 PFS final rule, based on
robust feedback from interested parties indicating that the new CCM
codes did not fully capture the service time required to furnish care
to beneficiaries with more complex conditions, we finalized new codes
for patients with complex care management needs. In the CY 2016 PFS
final rule, in considering how to improve the accuracy of our payments
for care coordination, particularly for patients requiring more
extensive care management, we stated that we believe the care
coordination and management for Medicare beneficiaries with multiple
chronic conditions, a particularly complicated disease or acute
condition, or certain behavioral health conditions often requires
extensive discussion, information-sharing, and planning between a
primary care physician and a specialist (for example, with a
neurologist for a patient with Alzheimer's disease plus other chronic
diseases) (80 FR 70919).
[[Page 61706]]
[GRAPHIC] [TIFF OMITTED] TP31JY24.043
(1) Level 1 APCM
We are proposing the Level 1 APCM code for patients with one or
fewer chronic conditions because of the increased import and use of
non-face-to-face interactions in advanced primary care even for
patients with relatively fewer health needs, which has increased over
time for several observable reasons, including broad evolution in
information and communication technology in everyday life, diffusion of
practices first adopted for higher-acuity patients, and continuing
practices widely adopted during the COVID-19 pandemic that reduce
reliance on in-person interactions. We believe APCM services for a
patient diagnosed with one or fewer chronic conditions will require
significantly less time and resources than one with two or more chronic
conditions since, in general, there would be fewer ongoing health needs
and other health care resources to coordinate, a lower risk of drug
interactions, and less complicated physiology. Based on CY 2010
Medicare claims data, the difference in annual expenditures per
beneficiary between patients with one or fewer chronic conditions and
those with two or three chronic conditions was $3,673.\44\ Our current
care management coding similarly delineates patient complexity between
patients with a single serious chronic condition (PCM codes) and those
with two or more serious chronic conditions (CCM codes). We anticipate
that practitioners who would furnish APCM services may have already had
experience with care management services coding and payment for much of
this population. The Level 1 APCM code would also address the current
gap in coding and payment for care management services furnished using
an advanced primary care model for patients without multiple chronic
conditions.
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\44\ Centers for Medicare and Medicaid Services. Chronic
Conditions among Medicare Beneficiaries, Chartbook, 2012 Edition.
Baltimore, MD. 2012. https://www.cms.gov/research-statistics-data-and-systems/statistics-trends-and-reports/chronic-conditions/downloads/2012chartbook.pdf.
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(2) Level 2 APCM
We are proposing the Level 2 APCM code for patients with two or
more chronic conditions because of the frequency of chronic conditions
in the Medicare population. In fact, nearly four in five Medicare
beneficiaries have two or more chronic conditions.\45\ Furthermore, as
noted previously, our current care management coding delineates patient
complexity for the CCM codes for patients with two or more serious
chronic conditions, and we anticipate that practitioners who would
furnish APCM services may have already had experience with care
management services coding and payment for much of this population.
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\45\ Lochner, K., Goodman, R., Posner, S., & Parekh, A. (n.d.).
Multiple Chronic Conditions Among Medicare Beneficiaries. CMS.
https://www.cms.gov/mmrr/Downloads/MMRR2013_003_03_b02.pdf.
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For example, someone with chronic kidney disease and heart failure
requires regular check-ins, coordination with specialty care, follow-up
after hospital admissions for heart failure exacerbations, regular
modifications of the care plan, and more. These services are typically
described by the existing CCM services. The patient may also typically
need to reach out more often to their primary care practitioner with
questions or new symptoms via the patient portal. For instance, the
person sends a message through the patient portal to ask whether or not
they should come into the primary care office after gaining ten pounds
in the last week--which could be a sign of increased fluid retention
and the need for increased diuretic dosages to avoid pleural edema (an
accumulation of fluid in the lungs). The primary care team books the
patient for a same-day urgent care appointment to assess for signs of
swelling and pleural edema. Again, this on-demand access to their
primary care team can help treat the patient's chronic conditions in a
patient-centered way and avoid unnecessary complications.
(3) Level 3 APCM
We are proposing the Level 3 APCM code for patients with QMB status
and two or more chronic conditions based on our understanding that
people with both multiple chronic conditions and social risk factors
generally require even more time and resources from primary care
practitioners and their teams to ensure that the patient's chronic
conditions are managed appropriately and effectively. We are proposing
to use a patient's QMB status as a method to identify beneficiaries
with social risk factors that generally necessitate relatively greater
resource requirements to effectively furnish advanced primary care than
people without such risk factors. There is significant evidence that
such dually eligible beneficiaries, on average, are more medically
complex and have higher healthcare needs; \46\ for example, dually
eligible beneficiaries are more likely to have poor functional status
\47\ and recent expenditure data found that the difference in Medicare
spending on a per person per year basis between dually eligible and
non-dually eligible Medicare beneficiaries was $13,198 in CY 2021.\48\
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\46\ Kaiser Family Foundation. (n.d.). A primer on Medicare:
What is the role of Medicare for dual-eligible beneficiaries?
Retrieved June 24, 2024, from https://www.kff.org/report-section/a-
primer-on-medicare-what-is-the-role-of-medicare-for-dual-eligible-
beneficiaries/
#:~:text=A%20larger%20share%20of%20dual,beneficiaries%3B%20and%20more
%20than%20half%20(.
\47\ ASPE. Report to Congress: Social Risk Factors and
Performance Under Medicare's Value-Based Purchasing Programs.
December 2016. https://aspe.hhs.gov/reports/report-congress-social-risk-factors-performance-under-medicares-value-based-purchasing-programs.
\48\ https://www.macpac.gov/wp-content/uploads/2024/01/Jan24_MedPAC_MACPAC_DualsDataBook-508.pdf.
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QMBs are the largest eligibility group within the Medicare-Medicaid
dually eligible enrollee population, comprising of 66 percent of the
12.8 million individuals per the most recent available data.\49\ For
the approximately 8.5 million dually eligible beneficiaries who are
QMBs, Medicaid provides assistance for patients to meet Medicare's
cost-sharing requirements. The QMB eligibility group helps to ensure
full access to the Medicare benefit for the lowest income enrollees by
covering these costs. Individuals can qualify for QMB status if their
income is below 100 percent of the Federal Poverty Level ($15,300/year
in 2024) and assets are no more than $9,430/$14,130 (one person/married
couple in 2024), although states can request CMS approval to disregard
certain income and assets.\50\ Beneficiaries apply for this
[[Page 61707]]
benefit with their State's Medicaid program and must be redetermined
eligible at least annually.
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\49\ Beneficiaries Dually Eligible for Medicare and Medicaid.
Data from CY 2021. (January 2024). Medpac and Macpac. https://www.macpac.gov/wp-content/uploads/2024/01/Jan24_MedPAC_MACPAC_DualsDataBook-508.pdf.
\50\ Access to Care Issues Among Qualified Medicare
Beneficiaries (QMB). (2015). Centers for Medicare & Medicaid
Services. https://www.cms.gov/Medicare-Medicaid-Coordination/Medicare-and-Medicaid-Coordination/Medicare-Medicaid-Coordination-Office/Downloads/Access_to_Care_Issues_Among_Qualified_Medicare_Beneficiaries.pdf.
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There is growing recognition that social risk factors--such as
income, education, access to food and housing, and employment status--
play a major role in health,\51\ such that social risk factors may
affect a person's ability to reach their health goals, as well as the
diagnosis and treatment of their medical problems. A report submitted
to Congress by the Office of the Assistant Secretary for Planning and
Evaluation (ASPE) in response to the Improving Medicare Post-Acute Care
Transformation (IMPACT) Act of 2014 (Pub. L. 113-185) found that dual
Medicare-Medicaid enrollment as a marker for low income was typically
the most powerful predictor of poor outcomes on quality measures among
social risk factors examined.\52\ Beneficiaries with social risk
factors may have worse health outcomes due to a host of factors,
including higher levels of medical risk, worse living environments (for
example, availability of community services, pollution, safety),
greater challenges in adherence to medication regimens and medical
recommendations (for example, diet/lifestyle), and/or bias or
discrimination. Evidence suggests that many health outcomes are related
more to social, environmental, and economic factors (which may be
beyond practitioners' control) than to clinical interventions.\53\ Dual
enrollees, and more specifically, QMBs, are therefore a category of
Medicare beneficiaries who we believe to be the most socially at-risk
of poorer clinical outcomes. As stated in the ASPE report, ``Some of
the observed relationship between social risk factors and outcomes may
be the result of underlying differences in medical complexity, frailty,
disability, and/or functional status. For example, dually-enrolled
beneficiaries are more likely to have poor functional status, and
therefore, may be more likely to be readmitted after a
hospitalization.'' As another example, a patient with diabetes, heart
failure, and QMB status may experience food, transportation, or housing
insecurity that contributes to difficulty maintaining blood glucose
control which can contribute to medical complications including
potentially preventable heart failure exacerbations. The primary care
practitioner's team may need to check-in regularly to ensure, for
example, that the patient gets needed specialty care such as an
ophthalmologic examination to avoid the ocular manifestations of
diabetes; and consider the availability of transportation vouchers so
the patient can attend the ophthalmology appointment. We are proposing
the Level 3 APCM code to recognize the unique characteristics of QMBs
as beneficiaries with social risk factors for whom significantly more
resources are involved in comprehensive care management by
practitioners that furnish advanced primary care services to them.
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\51\ Long P, Abrams M, Milstein A, Anderson G, Apton KL,
Dahlberg M, Whicher D. Effective care for high-need patients.
Washington, DC: National Academy of Medicine. 2017. https://nam.edu/wp-content/uploads/2017/06/Effective-Care-for-High-Need-Patients.pdf; Schroeder, S. (2007, September 20). We Can Do Better--
Improving the Health of the American People. New England Journal of
Medicine, 357(12), 1221-1228. https://www.nejm.org/doi/full/10.1056/NEJMsa073350.
\52\ ASPE. Report to Congress: Social Risk Factors and
Performance Under Medicare's Value-Based Purchasing Programs.
December 2016. https://aspe.hhs.gov/reports/report-congress-social-risk-factors-performance-under-medicares-value-based-purchasing-programs.
\53\ World Health Organization. (2018). Health Impact Assessment
(HIA): The determinants of health. https://www.who.int/hia/evidence/doh/en/.
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Additionally, we note that patients with QMB status are not
responsible for the Medicare cost-sharing associated with covered
Medicare Part A or B services, including for any APCM services.
Generally, States cover such cost-sharing on behalf of QMBs, although
many states use a ``lesser-of'' policy through which states pay less
than the full cost sharing amounts.\54\ We solicit comments from States
on how they would cover cost sharing for the proposed APCM bundle,
considering lesser-of policies.
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\54\ Under the ``lesser of'' policy, a State caps its payment of
Medicare cost-sharing at the Medicaid rate for a particular service.
For example, if the Medicare rate for a service is $100, of which
$20 is beneficiary coinsurance, and the Medicaid rate for the
service is $90, the state would only pay $10. If the Medicaid rate
is $80 or lower, the state would make no payment.
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We are also seeking feedback on the use of QMB status and multiple
(two or more) chronic conditions as the basis to bill for APCM Level 3
(GPCM3), whether QMB status is an appropriate indicator to identify
beneficiaries with added social risk, and whether there is an
equivalent marker of social deprivation for use in commercial markets
that might be a possible alternative identifier.
c. APCM Service Elements and Practice-Level Capabilities
All the elements within the scope of APCM services are included in
the service descriptors for GPCM1, GPCM2, and GPCM3, listed in Table
22, and described in this section. As described above, we are proposing
that APCM services would include nearly the same scope of service
elements and conditions we established for CCM and PCM services
(including elements of 24/7 access and care continuity, care management
and care plan, care coordination, management of care transitions, and
enhanced communication). We believe this is appropriate because care
management is a key component of care delivery using an advanced
primary care model. The proposed phrasing in the code descriptors for
APCM services generally tracks the code descriptors for CCM and PCM
services, except for references to ``time spent'' or ``minutes'' of
service.
We are seeking to ensure that the APCM codes would fully and
appropriately capture the care management and CTBS services that are
characteristic of the changes in medical practice toward advanced
primary care, as demonstrated in select CMS Innovation Center models.
As we do for CCM and PCM services, we propose to require for APCM
services that the practitioner provide an initiating visit and obtain
beneficiary consent (see section II.G.2.c.(1) and II.G.2.c.(2) of this
proposed rule). As described in more detail below, we are proposing to
incorporate as elements of APCM services ``Management of Care
Transitions'' and ``Enhanced Communications Opportunities.'' For the
``Management of Care Transitions'' APCM service element, we are
proposing to specify timely follow-up during care transitions (see
section II.G.2.c.(6) of this proposed rule). For the ``Enhanced
Communications Opportunities'' APCM service element, we are proposing
to incorporate access to CTBS services, including remote evaluation of
pre-recorded patient information and interprofessional telephone/
internet/EHR referral service(s), to maintain ongoing communication
with the patient, as well as access to patient-initiated digital
communications that require a clinical decision, such as virtual check-
ins and digital online assessment and management and E/M visits (or e-
visits) (see section II.G.2.c.(8) of this proposed rule).
We are also proposing to specify for APCM services the practice-
level characteristics and capabilities that are
[[Page 61708]]
inherent to, and necessarily present when a practitioner is providing
covered services using an advanced primary care delivery model. As
described in more detail below, included in the service descriptors for
GPCM1, GPCM2, and GPCM3, and listed in Table 22, our proposed practice-
level capabilities that reflect care delivery using an advanced primary
care model are focused around 24/7 access and continuity of care (see
section II.G.2.c.(3) of this proposed rule), patient population-level
management (see section II.G.2.c.(9) of this proposed rule), and
performance measurement (see section II.G.2.c.(10) of this proposed
rule). These practice capabilities are indicative of, and necessary to,
care delivery using an advanced primary care model. Further, APCM
services, as we propose to define them, could not be fully performed in
the absence of these practice capabilities; and, in such cases, APCM
services should not be billed.
We are proposing that practitioners participating in the ACO REACH
model, the Making Care Primary model, and the Primary Care First model
would satisfy the proposed initiating visit, patient population-level
management, and performance measurement APCM service elements and
practice-level capabilities by virtue of their model participation.
These CMS Innovation Center models promote advanced primary care
delivery consistent with the proposed APCM service elements and
practice-level capabilities described in Table 21. The models all
utilize attribution methods that review the most recently available two
years of Medicare claims to identify whether a model participant is
responsible for a Medicare beneficiary's primary care, aligning with
the initiating visit requirements for APCM services. Additionally,
these three models also include risk stratification and quality and
cost performance metrics that are aligned or overlap with the Value in
Primary Care MVP.\55\ Around-the-clock access and continuity of care,
patient population-level management, and performance measurement are
indicative of, and necessary to, care delivery using an advanced
primary care model. We are also considering whether certain
practitioners in other types of CMS Innovation Center models also
satisfy the proposed service elements and requirements and seek
comments on this question.
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\55\ See, e.g., ACO Realizing Equity, Access, and Community
Health (REACH) Model Request for Applications. Available at https://www.cms.gov/priorities/innovation/media/document/aco-reach-rfa, ACO
Realizing Equity, Access, and Community Health (REACH) Model PY 2024
Quality Measurement Methodology. Available at https://www.cms.gov/files/document/aco-reach-quality-msr-meth-py24.pdf; Making Care
Primary Payment and Attribution Methodologies. Available at https://www.cms.gov/files/document/mcp-pymt-att-methodologies.pdf, Primary
Care First Payment and Attribution Methodologies PY 2024. Available
at https://www.cms.gov/files/document/pcf-py24-payment-meth.pdf.
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BILLING CODE P
[[Page 61709]]
[GRAPHIC] [TIFF OMITTED] TP31JY24.044
[[Page 61710]]
[GRAPHIC] [TIFF OMITTED] TP31JY24.045
BILLING CODE C
We are seeking comment on whether the proposed elements and
requirements are appropriately reflective of care management services
for advanced primary care, and whether there are proposed elements of
APCM services or proposed practice capabilities that should be modified
or removed. We are also seeking feedback on ways to align the APCM
services with other Medicare programs and initiatives, such as the
Shared Savings Program, ACO REACH, and advanced primary care models,
and the Quality Payment Program, including MIPS and Advanced
Alternative Payment Models (Advanced APMs). We seek to create a low
burden way for practitioners to furnish APCM services by appropriately
recognizing ways in which they may meet APCM billing requirements as
part of these programs and initiatives. We note that under the Quality
Payment Program, practitioners who are MIPS eligible clinicians would
report measures and activities as specified by CMS under the four MIPS
performance categories: quality, cost, improvement activities, and
Promoting Interoperability (PI). To report to MIPS for a performance
period (Sec. 414.1320(i)) for the PI performance category, a MIPS
eligible clinician must use Certified EHR Technology (CEHRT), as
defined at paragraph (2) under CEHRT at Sec. 414.1305, report on the
objectives and associated measures as specified by CMS, and submit
required attestations as specified in Sec. 414.1375(b)(3) (Sec.
414.1375(b)). Eligible clinicians who participate in Advanced APMs
under the Quality Payment Program are required under the terms of those
APMs to use CEHRT as specified in Sec. 414.1415(a)(1)(iii); and are
paid under the terms of those APMs based on MIPS-comparable quality
measures as specified in Sec. 414.1415(b).
As described in the sections below, we are proposing that a billing
practitioner who is part of a Shared Saving Program ACO, or CMS
Innovation Center ACO or participating in Making Care Primary or
Primary Care First would already satisfy the proposed practice-level
requirements for patient population-level management (see section
II.G.2.c.(9) of this proposed rule), and performance measurement (see
section II.G.2.c.(10) of this proposed rule) by meeting separately
applicable participation requirements within the Shared Savings
Programs and models. As noted previously, we are considering whether
practitioners in other types of CMS Innovation Center models also
satisfy certain proposed service elements and practice-level
requirements through their participation in the models, and seek
comments on this question.
(1) Beneficiary Consent
Consistent with other care management services, we are proposing
that the beneficiary's consent to receive APCM services must be
documented in the medical record as a condition of payment for APCM
services, as not all Medicare beneficiaries for whom APCM services
would be medically necessary may want to receive these services. As we
do for CCM and PCM services, we are proposing to require billing
practitioners to inform the beneficiary of the availability of APCM
services, and ensure the beneficiary is aware that Medicare cost-
sharing usually applies (though these costs may be covered through
supplemental health coverage). The practitioner should also inform the
beneficiary that, by providing APCM services, they intend to assume
responsibility for all of the patient's primary care services and serve
as the continuing focal point for all needed health care services; and
that only one
[[Page 61711]]
practitioner can furnish and be paid for APCM services during a
calendar month, but that their consent to receive APCM services does
not limit their option to receive Medicare covered health care services
from other practitioners. The practitioner should inform the
beneficiary that APCM is an ongoing, monthly service and of their right
to stop APCM services at any time (effective at the end of the calendar
month), and that they only need to provide consent once to receive APCM
services from the practitioner. We are proposing that the practitioner
would document in the beneficiary's medical record that this
information was explained and note whether the beneficiary accepted or
declined APCM services. We note that practitioners can still elect to
obtain written consent rather than verbal consent.
Practitioners have informed us that beneficiary cost sharing is a
significant barrier to provision of similar care management services,
such as CCM services. The proposed patient consent requirement is
intended to ensure that patients do not incur unexpected expenses for
care that is largely, or in significant part, non-face-to-face in
nature. The proposed requirement for patient consent would also help to
avoid duplicative practitioner billing, as the patient would understand
that the practitioner intends to serve as the focal point for all their
care, and that only one practitioner can furnish and be paid for APCM
services in any particular month.
We seek feedback on these proposed requirements, including how best
to effectively educate both practitioners and beneficiaries on the
benefits of APCM, especially as it reflects a new bundle of services
that may have previously been separately billed, and whether a CMS-
provided template to facilitate patient consent would be helpful. We
also seek feedback on whether CMS should require practitioners to
revisit consent for APCM services on an ongoing basis with patients.
(2) Initiating Visit
Consistent with CCM services (CPT codes 99437, 99439, 99487, and
99489-99491) and PCM services (CPT codes 99424-99427), we are proposing
to require an initiating visit for APCM services only for new patients
instead of for all beneficiaries receiving APCM services. Consistent
with the definition of ``new patient'' as described in the CPT[supreg]
2024 Professional Edition Code Book on page 4, we are proposing to
define a ``new patient'' as a person who did not receive any
professional services from the physician or other qualified health care
professional or another practitioner in the same group practice within
the previous 3 years.\56\ The initiating visit furnished in advance of
APCM services establishes the beneficiary's relationship with the
billing practitioner, ensures the billing practitioner assesses the
beneficiary prior to initiating APCM services, facilitates collection
of comprehensive health information to inform the care plan, and
provides an opportunity to obtain beneficiary consent (although
beneficiary consent can be obtained outside of the initiating visit).
We are proposing that the same services that can serve as the
initiating visit for CCM services could serve as the initiating visit
for APCM, including a Level 2 through 5 E/M visit, initial preventive
physician exam (IPPE), or TCM service, and we propose that the
initiating visit could be provided in person or as a Medicare
telehealth service.
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\56\ American Medical Association. CPT Professional 2024.
American Medical Association, 2023.
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We are proposing that an initiating visit would not be required for
``established patients'' based on certain circumstances that we believe
demonstrate an established patient-practitioner relationship in advance
of furnishing APCM services: (1) if the beneficiary is not a new
patient (has been seen by the practitioner or another practitioner in
the same practice within the past three years) or (2) if the
beneficiary received another care management service (including an APCM
service, non-complex or complex CCM service (CPT codes 99487, 99489,
99490, 99491, 99439, 99437), or PCM service (CPT codes 99424, 99425,
99426, 99427)) within the previous year with the practitioner or
another practitioner in the same practice. We do not believe there
necessarily is a need for an initiating visit for APCM services for
patients with whom the practitioner (or another in the same practice)
has an established relationship; and we would not want to require an
initiating visit under circumstances where a visit may not be medically
necessary. The proposed policy not to require an initiating visit for
beneficiaries who have received any professional service from the
physician or other qualified health care professional or another
practitioner in the same group practice within the previous 3 years is
consistent with CPT's definition of the term ``established patient,''
such that we believe this captures patients who have been seen
relatively recently and who have an existing relationship with the
practice. In the case of beneficiaries who have received care
management services from a practitioner within the practice in the past
year, we believe this indicates that the patient is also an
``established patient'' in that the patient has an existing
relationship with the practice, and the patient previously has
consented to the receipt of care management services, which have
overlapping service elements with APCM services.
We note that these standards would be consistent with applicable
Shared Savings Program and CMS Innovation Center patient attribution
standards in ACO REACH, Making Care Primary, and Primary Care First.
Any beneficiary eligible to be assigned to an ACO because of an
established care relationship between the beneficiary and a billing
practitioner who would be billing for APCM services under the ACO
participant's TIN, including beneficiaries who voluntarily aligned to a
practitioner in the ACO, would not be considered a new patient and
would not require an initiating visit. Medicare rules governing patient
attribution to an ACO on the basis of care provided by an ACO-
participating clinician similarly establishes where an existing care
relationship exists. Similarly, beneficiaries eligible to be assigned
to a REACH ACO, or a Making Care Primary or Primary Care First practice
because of an established care relationship between the beneficiary and
a billing practitioner who would be billing for APCM services under the
model participant's TIN, including beneficiaries who voluntarily
aligned to a practitioner participating in one of these three models
would not be considered a new patient and would not require an
initiating visit. While we are proposing certain exceptions to the
initiating visit requirement for APCM services, we note that an
initiating visit may still be needed even when not required, and the
billing practitioner can always furnish and bill for medically
necessary visits, including before initiating APCM services.
We seek feedback on these proposed requirements, including whether
additional services could serve as the initiating visit and whether a
different period of time (for example, patients not seen within one or
two years) would be more appropriate.
(3) 24/7 Access and Continuity of Care
Access and continuity build on the patient-practitioner
relationship to ensure patients receive the right care at the right
time from the right care team member. We are proposing to include for
APCM services the same scope of service elements we established for CCM
and PCM services for 24/7 Access
[[Page 61712]]
and Continuity of Care with some modifications. For 24/7 Access to
Care, the scope of the service element we propose for APCM services
would be to provide 24/7 access for urgent needs to the care team/
practitioner with real-time access to patient's medical records,
including providing patients/caregivers with a way to contact health
care professionals in the practice to discuss urgent needs regardless
of the time of day or day of week.
As described in the CY 2017 PFS final rule, this accurately
reflects the potential role of clinical staff or call-sharing services
in addressing after-hours care needs, and that after-hours services
typically would and should address any urgent needs and not only those
explicitly related to the beneficiary's chronic conditions (79 FR
67722). In advanced primary care models of care, primary care practices
should be at the center of that care--providing an effective ``first
contact'' for patients, supporting patients in their management of
care, and coordinating across different settings of care. Achieving
this level of access to primary care requires timeliness and an
effective relationship with those in the practice who are providing
that care. True access is fully informed by knowledge about the patient
and their care, which is only possible through real-time access to the
patient's electronic health information. Access to primary care,
informed by health information technology (IT), makes the right care at
the right time possible, potentially avoiding costly urgent and
emergent care. Practices can achieve 24/7 access to care informed by
health IT through call coverage by a practitioner with health IT system
access. This can be a practitioner from the practice or a covering
practitioner who has system access. Many practices and systems use
nurse call lines or answering services working with standard protocols
to provide the initial point of contact after hours and effectively
address common problems. In this situation, an escalation protocol will
engage a practitioner with system access when needed for decision
making. Other successful practices expand hours, add urgent care
services or partner with other practices to provide these services, or
contract with existing urgent care providers to manage and coordinate
care after regular office hours.
For Continuity of Care, the scope of service element would be to
provide continuity of care with a designated member of the care team
with whom the patient is able to schedule successive routine
appointments. Continuity of care refers to the ability of patients to
receive care from practitioners who know them and are known by them.
This continuity builds and reinforces a relationship based in trust and
shared experience that is highly valued by both practitioners and
patients. Practice focus on continuity of care can translate to
improved preventive and chronic care, patient and practitioner
satisfaction, lower hospital utilization, and lower costs.\57\
Depending on the type and setting of care, there are three components
of continuity that improve patient outcomes and experience: \58\
relational continuity (defined as the ``ongoing therapeutic
relationship between a patient (and often their family/caregiver)''
which is foundational in advanced primary care), informational
continuity (where practitioners have access to information on patients'
past events and personal circumstances to inform current care
decisions); and longitudinal continuity (which refers to ongoing
patterns of healthcare visits that occur with the same practice over
time). A key strategy to optimize continuity is ensuring that all
practitioners and/or the care team have access to the same patient
information to guide care within health IT, and successful practices
start with a review and discussion of the practice-level data developed
through measurement of continuity.\59\ Practices can develop the
capability to measure continuity of care between the patient and the
practitioner/care team using health IT, practice management software,
or other tracking mechanisms, allowing them to track improvements over
time.
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\57\ Hussey, P.S., Schneider, E.C., Rudin, R.S., Fox, D.S., Lai,
J., & Pollack, C.E. (2014). Continuity and the costs of care for
chronic disease. JAMA Internal Medicine, 174(5), 742-748; Bayliss,
E.A., Ellis, J.L., Shoup, J.A., Zeng, C., McQuillan, D.B., &
Steiner, J.F. (2015). Effect of continuity of care on hospital
utilization for seniors with multiple medical conditions in an
integrated health care system. The Annals of Family Medicine, 13(2),
123-129; Nyweide, D.J., Anthony, D.L., Bynum, J.P., Strawderman,
R.L., Weeks, W.B., Casalino, L.P., & Fisher E.S. (2013). Continuity
of care and the risk of preventable hospitalization in older adults.
JAMA Internal Medicine, 173(20), 1879-1885; Haggerty, J.L., Reid,
R.J., Freeman, G.K., Starfield, B.H., & Adair, C.E. (2003).
Continuity of care: a multidisciplinary review. BMJ, 327, 1219.
doi:10.1136/bmj.327.7425.1219; Gupta, R., & Bodenheimer, T. (2013).
How primary care practices can improve continuity of care. JAMA
Internal Medicine, 173(20), 1885-1886. doi:10.1001/
jamainternmed.2013.7341; Willard R., & Bodenheimer T. (2012, April).
The building blocks of high-performing primary care: Lessons from
the field. California Healthcare Foundation. https://www.chcf.org/publications/2012/04/building-blocks-primary-care.
\58\ Haggerty, J.L., Reid, R.J., Freeman, G.K., Starfield, B.H.,
& Adair, C.E. (2003). Continuity of care: a multidisciplinary
review. BMJ, 327, 1219. doi:10.1136/bmj.327.7425.1219.
\59\ Gupta, R., & Bodenheimer, T. (2013). How primary care
practices can improve continuity of care. JAMA Internal Medicine,
173(20), 1885-1886. doi:10.1001/jamainternmed.2013.7341; Willard R.,
& Bodenheimer T. (2012, April). The building blocks of high-
performing primary care: Lessons from the field. California
Healthcare Foundation. https://www.chcf.org/publications/2012/04/building-blocks-primary-care.
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As included in the APCM code descriptors, we are proposing to
specify for the ``24/7 Access to Care'' APCM service element that the
practice would maintain the capability to deliver care in alternative
ways to traditional office visits to best meet the patient population's
needs, such as e-visits, phone visits, home visits, and/or expanded
hours. This proposed standard for alternatives to office visits is
similar to several requirements tested in CMS Innovation Center models
(such as the CPC+ model's requirement that participating practices
regularly offer at least one alternative to traditional office visits
\60\), and reflects the understanding that providing alternatives to
traditional office visits is an essential element of the delivery of
care under an advanced primary care model of care. Moving care out of
traditional office visits can reduce demand and open supply for
prioritized visits. By changing where and how care is delivered,
practices may have increased availability for patients with complex
needs who may be better served by more time-intensive visits in the
office, at home, or in a nursing home. We are not proposing that a
practice would need to regularly deliver care in all these alternative
ways--for example, a practice may routinely offer e-visits and phone
visits, but not regularly furnish home visits, and still demonstrate
this primary care practice capability. Another practice might offer
extended hours on certain days to help patients who may find it hard to
take off work to see their clinician, and this would satisfy this
practice requirement.
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\60\ https://www.cms.gov/priorities/innovation/innovation-models/comprehensive-primary-care-plus.
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We seek feedback on these proposed requirements.
(4) Comprehensive Care Management
We are proposing for APCM services the ``Comprehensive Care
Management'' service element we established for CCM and PCM services
with some modifications. Rather than ``care management for chronic
conditions,'' the APCM service element would be ``overall comprehensive
care management'' which, like the element for CCM and PCM services, may
include, as applicable, ``systematic assessment of the patient's
medical, functional, and psychosocial needs;
[[Page 61713]]
system-based approaches to ensure timely receipt of all recommended
preventive care services; medication reconciliation with review of
adherence and potential interactions; and oversight of patient self-
management of medications.'' This care management standard is similar
to several requirements tested in CMS Innovation Center models (such as
the CPC+ model's requirement that participating practices provide
targeted, proactive, relationship-based care management to all patients
identified as at increased risk and likely to benefit from intensive
care management and provide short-term care management, including
medication reconciliation, to patients following hospital admission/
discharge/transfer, including observation stays, and, as appropriate,
following an ED discharge) \61\ and is an essential element of the
delivery of care under an advanced primary care model of care. Care
management is a resource-intensive process of working with patients,
generally outside of face-to-face office visits, to help them
understand and manage their health, navigate the health system, and
meet their health goals. Practices working with patients who have
complex care needs have found care management to be an effective and
necessary strategy for mitigating risk and improving health outcomes.
Practices have found it valuable to think in terms of two broad types
of patients who might benefit from different approaches to care
management: patients with some combination of multiple comorbidities,
complex treatment regimens, frailty and functional impairment,
behavioral and social risks, and serious mental illness who would often
benefit from long-term, proactive, and relationship-based longitudinal
care management; and patients who are otherwise stable and will benefit
from short-term, goal-oriented episodic care management during periods
of increased risk like transitions of care; diagnosis of a new, serious
illness or injury involving complex treatment regimens; or newly
unstable chronic illness.
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\61\ https://www.cms.gov/priorities/innovation/innovation-models/comprehensive-primary-care-plus.
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Successful practices use on-site, non-physician, practice-based, or
integrated shared care managers to provide longitudinal care management
for the highest risk cohort of patients, with assistance from other
practice staff, as needed. Multiple team members may engage in care
management, but each patient identified as eligible should have a
clinically trained individual in the practice who is accountable for
active, ongoing care management that goes beyond office-based clinical
diagnosis and treatment.\62\ Longitudinal care management is captured
in health IT and includes providing proactive care that moves beyond
traditional office visits or crisis-driven care (for example, ED care
or hospitalization) and is not primarily visit-based. Although office
visits are opportunities to define goals, plan patient care, engage in
shared decision making, and build a trusting relationship, most care
management activities take place by phone, patient portal, email, mail,
or home visits (and through visits to skilled nursing facilities or
hospitals to support transitional care).
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\62\ Taylor, E.F., Machta, R.M., Meyers, D.S., Genevro, J., &
Peikes, D.N. (2013). Enhancing the primary care team to provide
redesigned care: The roles of practice facilitators and care
managers. Annals of Family Medicine, 11(1), 80-83. doi:10.1370/
afm.1462.
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Practices use the concept of episodic care management to identify
patients who have acute or urgent needs using ``triggering events''
(for example, hospital discharge, new diagnoses, medical crisis, major
life event, decompensation in otherwise controlled chronic condition)
for short-term, problem-focused care management services. Episodic care
management is generally time-limited and problem focused and most often
includes coordination of services and follow-up, patient education and
support for self-management, and medication reconciliation.
We seek feedback on these proposed requirements.
(5) Patient-Centered Comprehensive Care Plan
We are proposing for APCM services the ``Comprehensive Electronic
Care Plan'' service element we established for CCM and PCM services
with some modifications. As included in the APCM code descriptors, we
are proposing to specify that the care plan is ``patient-centered''
which, as for CCM and PCM services, ``is available timely within and
outside the billing practice'' as appropriate to individuals involved
in the beneficiary's care, can be routinely accessed and updated by
care team/practitioner, and ``copy of care plan to patient/caregiver.''
Providing longitudinal care management, which is an essential
element of the delivery of care under an advanced primary care model of
care, includes the process of personalized care planning. The
personalized care planning process helps practices engage and
collaborate with patients to ensure that their care aligns with patient
preferences, goals, and values.\63\ A care plan is a mutually agreed-
upon document that outlines the patient's health goals, needs, and
self-management activities and is accessible to all team members
providing care for the patient. The care plan should be patient-
friendly, accessible to the patient, and should limit use of unfamiliar
medical jargon and acronyms. The care plan should also be structured
and standardized, documented in health IT to enable sharing among
patient, caregivers, and care team members. All high-risk patients
receiving longitudinal care management should have a personalized care
plan developed in a joint, open-ended conversation between the patient
and care team. Personalized care planning is a dynamic process;
therefore, the care plan document should be updated at regularly
defined intervals by the care team and patient. In addition, when
patients' health status, preferences, goals, and values change, their
plans of care should, too.
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\63\ Coulter A., Entwistle, V.A., Eccles, A., Ryan, S.,
Shepperd, S., & Perera, R. (2015). Personalised care planning for
adults with chronic or long-term health conditions. Cochrane
Database System Review, 3, CD010523; Edwards, S.T., Dorr, D.A., &
Landon, B.E. (2017). Can personalized care planning improve primary
care? JAMA, 318(1), 25-26.
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As described in the CY 2020 final rule, we proposed language to
describe the ``typical'' care plan elements which do not comprise a set
of strict requirements that must be included in a care plan for purpose
of billing but are intended to reflect those that are typically
included in a care plan as medically appropriate for a particular
beneficiary. The comprehensive care plan for all health issues
typically includes, but is not limited to, the following elements:
problem list; expected outcome and prognosis; measurable treatment
goals; cognitive and functional assessment; symptom management; planned
interventions; medical management; environmental evaluation; caregiver
assessment; interaction and coordination with outside resources and
practitioners and providers; requirements for periodic review; and when
applicable, revision of the care plan.
We seek feedback on these proposed requirements.
(6) Management of Care Transitions
We are proposing to adopt for APCM services the ``Management of
Care Transitions'' service element we established for CCM and PCM
services with some modifications. Rather than
[[Page 61714]]
requiring that the practice must facilitate communication of relevant
patient information through electronic exchange of continuity of care
documents with other health care providers regarding these transitions,
we are proposing more simply to require the billing practitioner to
``ensure timely exchange of electronic health information'' with other
practitioners and providers. As included in the APCM code descriptors,
we are also proposing to specify for the ``Management of Care
Transitions'' APCM service element that the care team/practitioner
would follow up with the patient and/or caregiver within 7 days after
each ED visit and hospital discharge. This proposed timely follow-up
standard is similar to several requirements tested in CMS Innovation
Center models (such as the CPC+ model's requirement that participating
practices ensure patients with ED visits received a follow-up
interaction within one week of discharge \64\ and the MCP model's
requirement that participating practices implement episodic care
management to provide timely follow-ups for high-risk patients post ED
visit and hospitalization \65\), and we patterned the timely follow-up
element after our policy for TCM services which requires, for example,
``communication (direct contact, telephone, electronic) with the
patient and/or caregiver with 2 business days of discharge'' and a
``face-to-face visit within 7 calendar days of discharge.'' Providing
timely follow-ups for patients is an essential element of the delivery
of care under an advanced primary care model of care, and we believe
this will help achieve timely, seamless care across settings especially
after discharge from a facility. Key aspects of follow-up after ED
visits and hospitalizations include identifying and partnering with
target hospitals and EDs where the majority of a practice's patients
receive services to achieve timely notification and transfer of
information following hospital discharge and ED visits.\66\ When
developing a standardized process for data exchange and timely follow-
up, successful practices include the following processes: information
and data exchange about patients seen in an ED or admitted to/
discharged from a hospital (for example, via HIE, hospital portal,
hospital-generated report, EHR, or additional health IT system);
definition for ``timely'' follow-up after discharge (for example, no
later than within 2 days of discharge from hospital admission or
observation stay and within 1 week of discharge from the ED); protocols
for when follow-up will be done (for example, before discharge or
following a standardized follow-up protocol); process of incorporating
into the patient's medical record so the information is available at
the time of the follow-up visit or other patient contact; and
standardized processes and protocols for data exchange and formalized
partnerships to develop an efficient workflow to ensure timely follow-
up and facilitate efficient and safe transitions of care.
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\64\ https://www.cms.gov/priorities/innovation/files/x/cpcplus-practicecaredlvreqs.pdf.
\65\ https://www.cms.gov/priorities/innovation/innovation-models/making-care-primary.
\66\ Carrier, E., Yee, T., & Holzwart, R.A. (2011). Coordination
Between Emergency and Primary Care Physicians (NIHCR Research Brief
No. 3). National Institute for Health Care Reform. https://nihcr.org/analysis/improving-care-delivery/prevention-improving-health/ed-coordination/; Ventura, T., Brown, D., Archibald, T., et al. (2010,
January-February). Improving care transitions and reducing hospital
readmissions: establishing the evidence for community-based
implementation strategies through the care transitions theme. https://www.communitysolutions.com/assets/2012_Institute_Presentations/caretransitioninterventions051812.pdf.
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Practices use a variety of scheduling strategies to prioritize
same-day or next-day access for acutely ill patients and to provide
timely follow-up for patients experiencing care transitions. Successful
practices are those that can strike the right balance between timely
access to visits and the offering patients a provider of their choice
(Continuity of Care). Establishing standardized protocols and pathways
to improve and ensure responsiveness and timely callbacks to patients
is an effective way to impact patient-practitioner/care team
communication and to ensure a safeguard for addressing emergent and
urgent patient phone calls. Successful practices routinely evaluate the
degree to which patients' phone calls are answered promptly or returned
within a practices' established guidelines (for example, non-urgent,
emergent, urgent) and routed to the appropriate practitioner or care
team member, incorporating patients' clinical needs and
preferences.\67\ Such strategies are paramount for practices whose
patients may be contacting the practice with care needs that require
care team prioritization and urgent reply.
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\67\ Hempel, S., Stockdale, S., Danz, M., Rose, D.E., Kirsh, S.,
Curtis, I., & Rubenstein, L.V. (2018). Access management in primary
care: Perspectives from an expert panel (Research Report No. RR-
2536-DVA). Rand Corporation. https://www.rand.org/content/dam/rand/pubs/research_reports/RR2500/RR2536/RAND_RR2536.pdf; O'Brien, L.K.,
Drobnick, P., Gehman, M., Hollenbeak, C., Iantosca, M.R., Luchs, S.,
Manning, M., Palm, S.K., Potochny, J., Ritzman, A., Tetro-Viozzi,
J., Trauger, M., & Armstrong, A.D. (2017). Improving responsiveness
to patient phone calls: A pilot study. Journal of Patient
Experience, 4(3), 101-107. doi:10.1177/2374373517706611.
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We seek feedback on these proposed requirements.
(7) Practitioner, Home-, and Community-Based Care Coordination
We are proposing to adopt for APCM services the ``Home- and
Community-Based Care Coordination'' service element we established for
CCM and PCM services with some modifications. As included in the APCM
code descriptors, we are proposing to specify that the ``ongoing
communication and coordinating receipt of needed services'' is with not
only with home- and community-based service providers, but also with
``practitioners,'' ``community-based social service providers,
hospitals, and skilled nursing facilities (or other health care
facilities), as applicable.'' We are also proposing to add more detail
about the communication documented in the patient's medical record in
that it would include ``the patient's psychosocial strengths and needs,
and functional deficits, goals, preferences, and desired outcomes,
including cultural and linguistic factors.''
Coordinated referral management with specialty groups and other
community or healthcare organizations ensures referrals are properly
managed, coordinated, and communicated. These efforts help practices
achieve goals of enhancing the quality of patient care, improving the
patient's care experience, and lowering cost, particularly for
practices serving high-risk patient populations. Evidence suggests that
the development of formal relationships (for example, collaborative
care agreements) between the primary care practice and referred groups/
organizations that define shared goals and responsibilities, facilitate
the coordinated referral management process.\68\ The foundation of
successful coordinated referral management with specialty groups and
other community or healthcare organizations is the development of
processes and procedures to ensure high-value referrals, such as
collaborative care agreements and electronic consultations (e-
Consults). Establishing clear and agreed-upon expectations regarding
communication and clinical responsibilities with specialty practices
and other care organizations, through a collaborative care agreement,
improves the process. Collaborative care agreements often
[[Page 61715]]
include the following elements: defining the types of referrals,
consultation, and co-management arrangements available; specifying who
is accountable for which processes and outcomes for care within the
referral, consultation, or co-management arrangement; and specifying
what clinical and other information should be provided, how the
information is transferred, and timeliness expectations. The electronic
e-Consults process is typically conducted through a system-wide EHR or
a secure, web-based system by which a practice receives guidance from a
specialty provider or other care organization.\69\ In this process, a
practitioner sends a clinical question and relevant clinical
information to the specialist (or other care organization), who
responds by providing a clinical opinion and guidance and/or confirms
the need for a face-to-face appointment with the patient. This tool and
process has the potential to streamline consultations, reduce cost and
burden for patients, and improve access to specialty care for high-
value referrals. As part of the CY 2019 PFS final rule, we finalized
interprofessional consultation services codes, which support payment
both to the treating, requesting (primary care) practitioner (CPT code
99452) and the receiving, consultative specialist (CPT codes 99446-
99449 and 99451) who engage in e-Consults, and so some practitioners
have already become accustomed to providing and billing for these
services.
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\68\ Medicare Payment Advisory Commission (MedPAC). (2012,
June). Report to the Congress: Medicare and the Health Care Delivery
System. https://medpac.gov/docs/default-source/reports/jun18_medpacreporttocongress_sec.pdf?sfvrsn=0.
\69\ Vimalananda, V., Gupte, G., Seraj, S., Orlander, J.,
Berlowitz, D., Fincke, B., & Simon, S. (2015, September). Electronic
consultations (e-consults) to improve access to specialty care: A
systematic review and narrative synthesis. Journal of Telemedicine
and Telecare 21(6), 323-330. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4561452/.
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Strategies for addressing common health-related social needs
(HRSNs) for a practice's high-risk patients include conducting needs
assessments at regular intervals, creating a resource inventory for the
most pressing needs of the patient population, and establishing
relationships with key community organizations. Practices can focus on
developing relationships with community-based organizations that
support patients' most significant HRSNs. Practices can also seek to
find common ground with community and social service organizations,
focus on the structure and process of referrals, and develop a
bidirectional flow of information. Successful practices work with their
patients to ensure there is a shared understanding of the purpose of
the referral and aim to understand bottlenecks and barriers to meeting
their needs through the process. Many practices identify a care team
member to be a community referral resource for their patients.
Successful referrals can help practices determine the most useful and
available resources in their community.
We seek feedback on these proposed requirements.
(8) Enhanced Communications Opportunities
We are proposing to include for APCM services the element of
``Enhanced Communications Opportunities'' we established for CCM and
PCM services with some modifications. Specifically, we would add
``internet and patient portal'' as examples of asynchronous non-face-
to-face consultation methods and specify that the practitioner would
provide ``other communication technology-based services, including
remote evaluation of pre-recorded patient information and
interprofessional telephone/internet/EHR referral service(s), to
maintain ongoing communication with patients, as appropriate'' as well
as specify ``access to patient-initiated digital communications that
require a clinical decision, such as virtual check-ins and digital
online assessment and management and E/M visits (or e-visits).''
Providing asynchronous non-face-to-face consultation methods and other
CTBS services is an essential element of the delivery of care under an
advanced primary care model of care, and we believe this will allow
patients to access their usual source of care more conveniently (see
section II.G.2.c.(3) of this proposed rule). There is growing consensus
that incorporating telehealth into primary care will allow patients to
access their usual source of care more conveniently.\70\ Patients using
telehealth visits have reported high satisfaction, identifying
convenience and perceived high quality of care as contributors,\71\
such that these may be a good alternative and, in some cases,
preferable to in-person communication.\72\ Expansion of telehealth to
address episodic and chronic conditions has been a significant trend in
the evolution of telehealth applications, and there is some evidence
that video visits may enable more timely communication of test results
than in-person appointments.
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\70\ Levine DM, Linder JA. Retail Clinics Shine a Harsh Light on
the Failure of Primary Care Access. J Gen Intern Med.
2016;31(3):260-262.; Dorsey ER, Topol EJ. State of Telehealth. N
Engl J Med. 2016;375(2): 154-161.; Powell, Rhea E., et al. ``Patient
perceptions of telehealth primary care video visits.'' The Annals of
Family Medicine 15.3 (2017): 225-229.
\71\ Polinski JM, Barker T, Gagliano N, Sussman A, Brennan TA,
Shrank WH. Patients' Satisfaction with and Preference for Telehealth
Visits. J Gen Intern Med. 2016;31(3):269-275.
\72\ Krishnan N, Fagerlin A, Skolarus TA. Rethinking Patient-
Physician Communication of Biopsy Results--The Waiting Game. JAMA
Oncol. 2015;1(8):1025-1026.; Cusack CM, Pan E, Hook JM, Vincent A,
Kaelber DC, Middleton B. The value proposition in the widespread use
of telehealth. J Telemed Telecare. 2008;14(4):167-168.
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As noted in section II.G.2.b. of this proposed rule, we are not
proposing timeframe restrictions for this proposed element, which
includes access to certain CTBS (for example, the restriction for
virtual check-in services that there is not a related E/M service
provided within the previous 7 days or an E/M service or procedure
within the next 24 hours or the soonest available appointment).
We seek feedback on these proposed requirements.
(9) Patient Population-Level Management
As specified in the proposed APCM code descriptors, we are
proposing to establish an APCM service element for Patient Population-
Level Management that would include practice capabilities for
population-based, data-driven approaches to manage preventive and
chronic care for their patient population and to plan and implement
strategies to improve care and outcomes. We are proposing that all
practices would use data to develop clear improvement strategies and
analytic processes to proactively manage population health, including
analyzing patient population data to identify gaps in care and risk-
stratifying the practice population based on defined diagnoses, claims,
or other electronic data to identify and target services to patients
(such as those at risk for poor health outcomes), and then would offer
additional interventions, as appropriate.
These proposed patient population-level management standards are
similar to several requirements tested in CMS Innovation Center models,
including CPC+, which found that model participants used data to
identify and resolve gaps in care. We have modeled the proposed patient
population-level management standards on the CPC+ care delivery
requirements. In the CPC+ Model, participating practices were required,
for example, to ``use a two-step risk stratification process for all
empaneled patients, addressing medical need, behavioral diagnoses, and
health-related social needs'' and ``define at least one subpopulation
of patients with specific complex needs, develop capabilities necessary
to better address
[[Page 61716]]
those needs, and measure and improve the quality of care and
utilization of this subpopulation.'' \73\ Central to the delivery of
advanced primary care is the organization of the practice into care
teams that have the data they need to manage their patient populations
and that have time allocated to plan and implement practice improvement
strategies.\74\ Using evidence-based protocols, registries, and the
registry functionality of the EHR, reminders and outreach help
practices deliver appropriate preventive care and consistent evidence-
based management of chronic conditions for the entire patient
population.\75\ Measurement of clinically relevant data at the
practice-level guides testing and implementing strategies to improve
care and outcomes. Patient population-level management capabilities are
essential to the delivery of care under an advanced primary care model
of care and enable practices to meet the preventive and chronic care
needs of their entire patient population. Regular use of data to
identify populations or groups of patients with similar needs allows
practices and care teams to use streamlined strategies, including
setting goals with measurable outcomes, to positively impact their
patient populations. Evidence shows that primary care teams supported
with real-time, population-level clinical outcomes data effectively
manage population health and address care gaps which eliminates
external costs to close gaps in care.\76\ More specifically, risk
stratification allows practitioners to identify beneficiaries for
longitudinal care management, track beneficiaries with higher levels of
need and manage their conditions, and prevent beneficiaries from
falling through the cracks, while developing strategies to address
those patients who are at increased and rising risk and most likely to
benefit from targeted, proactive, relationship-based care management
and other strategies essential to APCM.\77\ Empanelment, which assigns
each active patient to a practitioner and/or care team with
consideration of patient and caregiver preferences, allows practices to
build responsive care teams to optimize patient care and to address the
preventive, chronic, and acute needs of all patients, and provides a
way for practices to identify care gaps and proactively reach out to
patients who have not been seen or contacted in a while.\78\ For
example, we believe these elements of advanced primary care management
could increase screening rates and ultimately improve care of chronic
conditions, such as hypertension and diabetes.
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\73\ CPC+ Care Delivery Resource. January 2019.
\74\ CPC+ Care Delivery Resource. January 2019.
\75\ O'Malley AS, Draper K, Gourevitch R, Cross DA, Scholle SH.
Electronic health records and support for primary care teamwork. J
Am Med Inform Assoc. 2015 Mar;22(2):426-34. doi: 10.1093/jamia/
ocu029. Epub 2015 Jan 27. PMID: 25627278; PMCID: PMC4394968.
\76\ https://www.cms.gov/priorities/innovation/files/x/cpcplus-practicecaredlvreqs.pdf.
\77\ Hayes, S.L., & McCarthy, D. (2016, December 7). Care
Management Plus: Strengthening Primary Care for Patients with
Multiple Chronic Conditions. The Commonwealth Fund. https://www.commonwealthfund.org/publications/case-studies/2016/dec/care-management-plus; Hong, C.S., Siegel, A.L., & Ferris, T.G. (2014,
August). Caring for High-Need, High-Cost Patients: What Makes for a
Successful Care Management Program? The Commonwealth Fund https://
www.commonwealthfund.org/~/media/files/publications/issue-brief/
2014/aug/
1764_hong_caring_for_high_need_high_cost_patients_ccm_ib.pdf; Lakin,
J.R., Robinson, M.G., Obermeyer, Z., Powers, B.W., Block, S.D.,
Cunningham, R., Tumblin, J. M.m Vogeli, c., & Bernacki, R.E. (2019).
Prioritizing primary care patients for a communication intervention
using the ``Surprise Question'': A prospective cohort study. Journal
of General Internal Medicine, 8.
\78\ Grumbach, K., & Olayiwola, N.J. (2015). Patient
empanelment: The importance of understanding who is at home in the
medical home. Journal of the American Board of Family Medicine,
28(2), 170-272.; Altschuler, J., Margolius, D., Bodenheimer, T., &
Grumbach, K. (2012). Estimating a reasonable patient panel size for
primary care physicians with team-based task delegation. Annals of
Family Medicine, 10(5), 396-400. doi:10.1370/afm.1400.
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We note that this Patient Population-Level Management requirement
of the APCM services would be met for practitioners billing for APCM
services through a TIN that is participating in an ACO in the Shared
Savings Program by virtue of the practitioner's participation in the
ACO which must meet eligibility requirements for population management,
care coordination and quality improvement, including required processes
and patient-centeredness criteria in Sec. 425.112. We note that ACOs
in the Shared Savings Program and their practitioners are already
engaged in analyzing the patient population for care gaps, risk-
stratifying patients to further identify those at risk for poor health
outcomes, and identifying patients for whom additional interventions
are appropriate. Similarly, the ACO REACH, Making Care Primary, and
Primary Care First CMS Innovation Center Models all require their
participants to deploy population health strategies to identify and
offer interventions to mitigate health risks.\79\ Participants in these
models and their practitioners are already engaged in population health
management as described in Table 21.
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\79\ ACO Realizing Equity, Access, and Community Health (REACH)
Model Request for Applications. Available a: https://www.cms.gov/priorities/innovation/media/document/aco-reach-rfa, Making Care
Primary Request for Applications. Available at https://www.cms.gov/files/document/mcp-rfa.pdf, Primary Care First Request for
Applications Cohort 2. Available at https://www.cms.gov/priorities/innovation/media/document/pcf-cohort2-rfa.
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We seek feedback on these proposed requirements.
(10) Performance Measurement
We are proposing for the APCM services a practice-level requirement
of performance measurement of primary care quality, total cost of care,
and meaningful use of CEHRT. Performance measurement is a critical
element of care management services delivered in the context of
advanced primary care, and it forms the basis for practice improvement
efforts by enabling practices to identify key measures for improvement
activities (for example, cost and utilization data, clinical quality
measures, patient experience of care data). Quality measurement
improves care delivery, including prevention of heart attacks,
increasing vaccination rates, and improving patient safety,\80\ and
quality measures are also effective tools to ensure that high-quality
advanced primary care, including care management, is being delivered.
Several performance measurement requirements were tested in CMS
Innovation Center models (such as the CPC+ model's requirement that
participating practices use data at both the practice- and panel-level
to set goals to improve population health management and to
continuously improve patients' health, experience, and quality of care,
and decrease cost). Using data resources and developing workflows and
analytics to guide practice changes can help practices achieve
reductions in total utilization and cost of care, and improvements in
patient experience and quality of care. Improving upon key outcome
measures requires engaged clinical and administrative leadership and a
commitment to continuous, data-driven improvement.\81\ In the context
of the PFS, performance management through quality measurement as a
practice-level requirement also ensures integrity to the provision of
advanced primary care because it holds billing practitioners
accountable to factors that are affected by several service elements of
APCM coding. For example, effective patient-population level management
can mean the practices close care gaps in diabetes management, and the
billing practitioner would perform better on diabetes quality measures
that assess for a patient's control of hemoglobin A1c.
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\80\ https://www.ahrq.gov/patient-safety/quality-measures/21st-century/challenges.html.
\81\ https://www.cms.gov/priorities/innovation/innovation-models/comprehensive-primary-care-plus.
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[[Page 61717]]
We are proposing that this performance measurement practice-level
requirement can be met in several ways. For MIPS-eligible clinicians,
the requirement would be met by registering for and reporting the
``Value in Primary Care'' MIPS Value Pathway (MVP). A practitioner who
is part of a TIN that is participating as a Shared Savings Program ACO
or a REACH ACO, or a Primary Care First or Making Care Primary practice
would meet these requirements by virtue of the Shared Savings Program
and CMS Innovation Center quality reporting, assessment of quality
performance, accountability for total cost of care, and other program
and model requirements.
In the CY 2024 PFS final rule (88 FR 80042 through 80047), we
finalized ``The Value in Primary Care'' Merit-based Incentive Payment
System (MIPS) Value Pathway (MVP), which focuses on the clinical theme
of promoting quality care for patients in order to reduce the risk of
diseases, disabilities, and death; and it includes cost measures,
Promoting Interoperability (PI) measures, improvement activities, and
quality measures for common chronic conditions (for example,
hypertension, diabetes, depression).\82\ The Value in Primary Care MVP
contains the Adult Universal Foundation quality measure set, which is
consistent with the National Quality Strategy goal of using the
Universal Foundation measures across as many programs as is
feasible.\83\ This MVP is especially well-suited to reflect the
delivery of care using the advanced primary care model as it was
developed to include quality metrics that reflect clinical actions that
should be considered the foundations of primary care. The quality
measures include key elements such as cancer screening, immunization,
blood pressure management, behavioral health, care coordination,
person-centered care, and screening for social drivers of health. The
improvement activities include engaging community resources to address
drivers of health, implementing changes in the practice's patient
portal to improve communication and patient engagement, reviewing
practices in place on targeted patient population needs, and chronic
care and preventive care management for empaneled patients, aspects of
advanced primary care already discussed in this proposal. The cost
measures include costs for common chronic conditions, such as asthma/
chronic obstructive pulmonary disease (COPD), diabetes, depression, and
heart failure, as well as the Total Per Capita Cost (TPCC) measure,
which assesses the overall cost of care delivered to a patient with a
focus on the primary care they receive from their provider(s) and
captures the broader healthcare costs influenced by primary care.\84\
The Value in Primary Care MVP serves to demonstrate performance
measurement that is reflective of the care furnished using advanced
primary care delivery. To ensure performance measurement consistent
with the delivery of advanced primary care services, we are proposing
as an element of the APCM services that a practitioner who is a MIPS
eligible clinician as defined in Sec. 414.1305 can satisfy the
performance measurement requirement by registering for and reporting
the Value in Primary Care MVP for the performance year in which they
bill for APCM services. A MIPS eligible clinician can report to MIPS as
an individual, subgroup, group, APM Entity, or in any combination of
these four participation options, and can participate in multiple ways
to report MVPs.\85\
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\82\ Value in Primary Care. Quality Payment Program. https://qpp.cms.gov/mips/explore-mips-value-pathways/2024/M0005.
\83\ https://www.cms.gov/medicare/quality/cms-national-quality-strategy/aligning-quality-measures-across-cms-universal-foundation.
\84\ https://qpp.cms.gov/docs/cost_specifications/2023-12-13-mif-tpcc.pdf.
\85\ https://qpp.cms.gov/mips/mvps/learn-about-mvp-reporting-option?option=Group.
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MIPS-eligible clinicians who report the MVP are also required to
report the PI performance category measures and attestations throughout
the performance period in which they bill for APCM services,\86\ as
required under Sec. 414.1375(b) (Sec. 414.1365(c)(4)(i)) (see section
IV of this proposed rule for details on reporting the objectives and
measures for the MIPS PI performance category for CY 2025 performance
period/2027 MIPS payment year). The measures in the MIPS PI performance
category include measures such as electronic referral loops, receiving
and reconciling health information, and providing patients with
electronic access to their health information, all of which are
reflective of important communication and coordination channels between
primary care, other specialist practitioners caring for the patient,
and the patient themselves. In addition, as set forth in 42 CFR
414.1375(b)(3), the MIPS PI performance category also requires
submission of affirmative attestations: (1) regarding their cooperation
in good faith with ONC direct review of their CEHRT; and (2) that they
did not knowingly and willfully take action (such as to disable
functionality) to limit or restrict the compatibility or
interoperability of CEHRT.\87\
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\86\ The MIPS PI performance period is a minimum of 180
consecutive days in the calendar year that occurs 2 years prior to
the MIPS payment year (see 42 CFR 414.1320(i)).
\87\ Note that, under the Quality Payment Program, CMS may
reweight the MIPS PI performance category to zero percent of the
MIPS final score, and not require an individual, group, or virtual
group to use CEHRT and demonstrate whether they are a meaningful
user of CEHRT, by granting a significant hardship exception or other
type of exception based on certain circumstances as set forth in 42
CFR 414.1380(c)(2)(i)(C).
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For CCM services (CPT codes 99437, 99439, 99487, and 99489-99491)
and PCM services (CPT codes 99424-99427), we established that
practitioners must use CEHRT to record certain patient health
information in a structured format, provide patients with access to
their health information, and exchange all relevant patient health
information, including in providing the ``Management of Care
Transitions'' element of CCM services. For the APCM services, which are
furnished as part of a practitioner's care delivery using the advanced
primary care model, we are proposing for practitioners who are MIPS
eligible clinicians a practice-level requirement to register for and
report the MVP, including but not limited to the PI performance
category measures which focus on meaningful use of CEHRT, ensuring that
patients/caregivers and physicians or other qualified practitioners or
clinical staff have real-time access to patient's medical information.
We believe that comprehensive CEHRT use is a critical element of care
management services delivered in the context of advanced primary care.
As we stated in adopting the CEHRT use element for CCM and PCM
services, we believe that the meaningful use of CEHRT is vital to
ensure that practitioners are capable of providing the full scope of
services, such as timely care coordination and continuity of care (see
our prior discussion of this issue at 79 FR 67723 and 84 FR 62696), and
we believe that flexibility in how practices can provide the requisite
24/7 access to care, continuity of care, and management of care
transitions, can facilitate appropriate access to these services for
Medicare beneficiaries. The meaningful use of CEHRT helps ensure that
members of the care team have timely access to the patient's most
updated health information and offer an integrated view of a patient's
clinical history from different points of care, supporting continuing,
quality, and integrated healthcare while avoiding duplication of
efforts and costs, such as
[[Page 61718]]
repeated exams.\88\ For example, practices use EHRs to identify high-
risk patients with chronic conditions to better coordinate care and can
supplement the practice's EHR data with data from external sources (for
example, State-level quality organizations) to obtain a more
comprehensive view of patients. Practices can also integrate clinical
data from EHRs, health plan claims data, and county-level social
services data to evaluate population needs, stratify by risk, and
assess what programs would be most effective for supporting at-risk
patients.\89\ Standardized communication methods, enabled by CEHRT, are
a significant part of the advanced primary care delivery model. Health
IT systems that include remote access to the care plan or the full EHR
after hours, or a feedback loop that communicates back to the primary
care physician and others involved in the beneficiary's care regarding
after-hours care or advice provided, are extremely helpful.\90\ They
help ensure that the beneficiary receives necessary follow up,
particularly if the patient is referred to the ED, and follow up after
an ED visit is required under the element of ``Management of Care
Transitions.'' Accordingly, we believe the use of CEHRT or remote
access to the care plan is fundamental to providing the APCM service
elements of 24/7 Access to Care, Continuity of Care, and Management of
Care Transitions under an advanced primary care delivery model.
Requiring performance of the requirements in these measures and
attestations to the meaningful use of CEHRT is similar to several
requirements tested in CMS Innovation Center models (such as the PCF
model's requirement that participating practices adopt and maintain
CEHRT for electronic clinical quality measure reporting, support data
exchange with other providers and health systems, and connect to their
regional health information exchange (HIE),\91\ and the MCP model's
requirement that participating practices use EHR technology that has
been certified under the ONC Health IT Certification Program \92\).
Furthermore, the Shared Savings Program requires practitioners (that
is, MIPS eligible clinicians, QPs and Partial QPs) in all ACOs to
demonstrate meaningful CEHRT use through the reporting of the MIPS
Promoting Interoperability annually beginning in 2025.
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\88\ McDonald, C.J., Tang, P.C., Hripcsak, G. and In: (eds)
Biomedical Informatics. Springer, L. (2014), ``Electronic Health
Record Systems,'' in Biomedical Informatics, Shortliffe, E.H. and
Cimino, J.J., eds. London: Springer, pp. 391-421.
\89\ Harvey, Jillian B., et al. ``Understanding how health
systems facilitate primary care redesign.'' Health Services Research
55 (2020): 1144-1154.
\90\ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3475839/#CR25.
\91\ https://www.cms.gov/priorities/innovation/innovation-models/primary-care-first-model-options.
\92\ https://www.cms.gov/priorities/innovation/innovation-models/making-care-primary.
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We recognize that many practitioners who are not MIPS eligible
clinicians for a year would be excluded from MIPS by achieving
Qualifying APM Participant (QP) status based on their levels of
participation in an Advanced APM. Based on the characteristics of
Advanced APMs detailed in Sec. 414.1415, including the requirement
that payment is based on MIPS or MIPS-comparable quality measures,
practitioners who with QP status are necessarily engaging in
performance measurement through the Advanced APMs in which they
participate in a way that is consistent with advanced primary care. We
also recognize there are other practitioners who are not MIPS eligible
clinicians for other reasons, such as practitioners who are newly
enrolled in Medicare or bill a low volume of Medicare services. These
practitioners technically could bill for APCM services. However, newly
enrolled practitioners are only excluded from MIPS for one year, after
which the practitioner would either be a MIPS eligible clinician who
would need to report the MVP in order to bill for APCM services, or
excluded from MIPS on another basis such as QP status. In the case of
practitioners with low Medicare volume, we anticipate that they would
be unlikely to bill for APCM services since the delivery of advanced
primary care generally involves time and resources to establish
practice-level infrastructure, and the economies of scale usually make
this a more likely investment if the infrastructure can be utilized
across a larger patient panel.
We are also proposing that the performance measurement element of
the APCM services would be satisfied for practitioners billing for APCM
services through a TIN that is participating in a Shared Savings
Program ACO for a performance year in which they furnish APCM services.
ACOs are currently required to report the APP quality measure set on
behalf of their practitioners, and would be required to report the APP
Plus quality measure set as proposed in Section III.G. of this proposed
rule. Practitioners in ACOs are also already being held accountable for
reporting and performance and outcomes on many of the Universal
Foundation measures already, which are used in the Value in Primary
Care MVP, and the APP Plus quality measure set would fully align the
Shared Savings Program's quality performance standard with the
Universal Foundation measures upon the complete implementation of the
APP Plus measure set.
We propose to include the performance measurement requirement as an
element of APCM services furnished by practitioners. MIPS eligible
clinicians who intend to report on the Value in Primary Care MVP for
the CY 2025 must register to report the Value in Primary Care MVP as
described under Sec. 414.1365(b), a MIPS eligible clinician must
register for an MVP during between April 1 and November 30 of the
applicable CY performance period to report the MVP. MIPS eligible
clinicians submit data on measures and activities in the first quarter
of the year following (CY 2026) the MIPS performance period. Under this
proposal, a MIPS eligible clinician billing for APCM services furnished
in 2025 and who is satisfying the performance measurement requirement
through reporting the Value in Primary Care MVP, would need to register
for the MVP between April and November of 2025 and report data between
January and March 2026 on measures and activities in the Value in
Primary Care MVP relating to services furnished in 2025. A MIPS
eligible clinician billing for APCM services furnished in 2026 and who
is satisfying the performance measurement requirement through reporting
the Value in Primary Care MVP, would need to register for the Value in
Primary Care MVP between April and November of 2026, and report data
between January and March of 2027 on measures and activities in the
Value in Primary Care MVP relating to services furnished in 2026, and
so on in subsequent years.
As described above, we are seeking feedback on ways to align the
APCM services with other Medicare programs and initiatives, such as the
Shared Savings Program and the Quality Payment Program, including MIPS
and Advanced APMs. We seek to create a low burden way for practitioners
to furnish APCM services by appropriately recognizing ways in which
they may meet APCM billing requirements as part of these programs and
initiatives, including other ways that practitioners may be fulfilling
these performance measurement requirements. We are seeking feedback on
whether there are areas of duplication within the APCM service elements
and practice capabilities that we should consider addressing. We are
also seeking comment on how to appropriately align
[[Page 61719]]
the time period for which the practitioner bills the monthly APCM code
with the calendar year reporting period covered by the MVP, and how we
would verify and enforce the performance measurement requirement of the
APCM service.
We seek feedback on these proposed requirements.
d. Duplicative Services and Concurrent Billing Restrictions
In this section, we identify the services that would overlap
substantially with APCM services based on the proposed elements of the
scope of service for APCM which we have built into the service
descriptors for GPCM1, GPCM2, and GPCM3 (see sections II.G.2.b. and
II.G.2.c. of this proposed rule). As such, we are proposing that APCM
services could not be billed by the same practitioner or another
practitioner within the same practice for the same patient concurrent
with these other services: CCM, PCM, TCM, interprofessional
consultation, remote evaluation of patient videos/images, virtual
check-in, and e-visits. Given that we have intentionally designed the
proposed elements of APCM services to track closely with the elements
of several other care management service and CTBS codes, these services
are substantially duplicative of APCM services. Further, these specific
services (shown in Table 19) are duplicative with APCM services because
there is significant overlap in the patient populations included in the
code descriptors for these services and APCM services, such as patients
who have chronic conditions, high-risk conditions, or both complex and
chronic conditions.
BILLING CODE P
[[Page 61720]]
[GRAPHIC] [TIFF OMITTED] TP31JY24.046
BILLING CODE C
As we have described in the sections above, comprehensive care
management services are essential to providing advanced primary care in
the context of this proposal, and many of the service elements for CCM/
PCM/TCM shown in Table 19 are substantially the same as the elements we
are proposing for APCM services.
Also described above, providing CTBS is an essential element of the
delivery of care under an advanced primary care model of care.
Recognizing this, we designed the proposed APCM service elements to
substantially overlap with the elements of the CTBS (for example,
interprofessional consultation and e-Visits) shown in Table 22. CTBS
are used in delivery of advanced primary care to maintain ongoing
communication with patients and enable interprofessional care teams to
provide comprehensive support to manage chronic conditions over time,
which we believe will allow patients to access their usual source of
care more
[[Page 61721]]
conveniently.\93\ We also believe that interprofessional consultation
can help promote integration of behavioral health and primary care.\94\
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\93\ Levine DM, Linder JA. Retail Clinics Shine a Harsh Light on
the Failure of Primary Care Access. J Gen Intern Med.
2016;31(3):260-262.; Dorsey ER, Topol EJ. State of Telehealth. N
Engl J Med. 2016;375(2):154-161.; Powell, Rhea E., et al. ``Patient
perceptions of telehealth primary care video visits.'' The Annals of
Family Medicine 15.3 (2017): 225-229.
\94\ We are planning a separate proposal on expanding who can
bill for IPC, including clinical psychologists, LCSWs, marriage and
family therapists (MFTs), and MHCs; see further discussion in
section II.I of this proposed rule.
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We also considered whether other care management services (such as
Behavioral Health Integration (BHI)), services addressing HRSNs
(Community Health Integration (CHI), Social Determinants of Health Risk
Assessment, and Principal Illness Navigation (PIN)), and/or other CTBS
(Remote Physiologic Monitoring (RPM) and Remote Therapeutic Monitoring
(RTM)) would be duplicative of the proposed APCM services. We believe
that these services, when appropriate, may complement APCM services
rather than substantially overlap or duplicate services, and that these
other services are sufficiently different from the APCM services in the
nature and extent of the interventions and the qualifications of
individuals providing the services, to allow concurrent billing for
services when appropriate. While these may be services that a
practitioner using the advanced primary care model would be likely to
furnish, when appropriate, they are not part of the core, routinely and
universally essential elements of the advanced primary care model. We
also believe that several of these other services (such as BHI, CHI,
SDOH Risk Assessment, and PIN) could be supplemental to APCM for
patients that have very specific identified health care needs.
We are seeking more information from interested parties through our
Advanced Primary Care RFI about whether to consider incorporating
additional service elements into the APCM service elements and
valuation for APCM codes; and whether and, if so, how to best
incorporate E/M services into future coding (see section II.G.3. of
this proposed rule). We note that, for BHI services, there is an
established evidence base for approaches to caring for beneficiaries
with behavioral health conditions which involve integration in the
primary care setting, are typically provided by a primary care team,
and include structured care management with regular assessments of
clinical status and modification of treatment. BHI is a term that
refers broadly to collaborative care that integrates behavioral health
services with primary care. BHI is a team-based approach to care that
focuses on integrative treatment of patients with medical and mental or
behavioral health conditions. For BHI in particular, including CPT
codes 99492, 99493, 99494, and 99484 and HCPCS code G0323, we are also
seeking information regarding how evolving changes in practice may
warrant reconsideration of payment and coding policies.
We propose that the care management and CTBS codes that are
identified in Table 19 could not be separately billed with the APCM
codes for the same beneficiary by the same practitioner, or a different
one within the same practice, for the same service period. This would
prevent duplicative payments for substantially similar services and is
consistent with how we have paid for potentially overlapping care
management services in the past.
As we refine our APCM policies, we note that we are not currently
proposing to make changes to the coding and payment policies for the
existing care management and CTBS services, other than to prohibit
concurrent billing for the same patient during the same month by the
same practitioner or another in the same practice. For CY 2025, those
codes would still be available for practitioners who do not furnish
care using the advanced primary care model or who may prefer to
document the existing care management and CTBS codes rather than use
the new proposed APCM codes.
We are also seeking comment on potential overlap between APCM
services and other services currently paid under the PFS, including but
not limited to care management and care coordination and other CTBS. If
interested parties identify overlaps between APCM and other services,
we are seeking comment on whether the degree of overlap would warrant a
policy to restrict the services from being billed concurrently with
APCM. We also seek comment on whether any overlap would depend upon
whether the same or a different practitioner reports the services.
As we test new CMS Innovation Center models that include payments
for the services defined above, including CCM, PCM, TCM,
interprofessional consultation, remote evaluation of patient videos/
images, virtual check-in, and e-visits, or as changes in the advanced
primary care model of care or more general changes to Medicare payment
policy take place that affect existing CMS Innovation Center models,
consistent with existing policy, we will address potential overlaps
between payments made to model participants with our proposed payment
for APCM, elements of the proposed APCM service, and these duplicative
services, and seek to implement appropriate payment policies.
e. Valuation of APCM Services--GPCM1, GPCM2, and GPCM3
To improve the accuracy of payment for the kinds of services
furnished as part of advanced primary care and reduce the
administrative burden associated with current coding and billing rules,
we are proposing to create three HCPCS codes to use for reporting the
proposed APCM service (GPCM1, GPCM2, and GPCM3) (sections II.G.2.b. and
II.G.2.c. of this proposed rule). Although these codes are unique in
that they would be created to differentially pay for advanced primary
care management, the proposed APCM services incorporate elements of
existing services with the understanding that some patients will
require more resources and some fewer based on variability in patient
complexity and needs (see section II.G.2.b of this proposed rule). As
we ordinarily do, we are proposing to base the PFS valuation for APCM
codes on the resources involved in furnishing the typical case of the
service which may not necessarily reflect the actual resources involved
in furnishing every individual service.
In this section, we detail our proposed methods to identify a
typical case and set of resources involved in furnishing APCM, and the
proposed valuation of these codes. To value APCM, we compared the
service elements described by the proposed APCM codes to the values we
have established for the specific care management and CTBS codes on
which we modeled the proposed the service elements of the APCM codes
and which we built into the service descriptors for GPCM1, GPCM2, and
GPCM3 (see Table 19 and sections II.G.2.b. through II.G.2.d. of this
proposed rule). As stated above, we believe that the proposed elements
of APCM services reflect the comprehensive approach to care management
involved in care delivery using the advanced primary care model. This
is a model of primary care that is being integrated into current
medical practice. As such, we believe that it would be appropriate to
use the current valuation and uptake of the codes on which we modeled
the APCM codes to inform our valuation of APCM services. Using Medicare
FFS claims data and evidence from our primary care models, we sought to
understand how these
[[Page 61722]]
different services have been used historically and relate that
information to the way we are thinking about the service elements for
APCM and the valuation of the three APCM code levels. We know that for
Medicare beneficiaries who receive care management services during a
year, the non-complex CCM base code is billed on average for five
months and with three add-on codes during those five months. We also
know that initial information from practitioner interviews conducted as
part of our CCM evaluation efforts indicates that practitioners
overwhelmingly meet and exceed the 20-minute threshold time for billing
the non-complex CCM base code; typically, these practitioners reported
spending between 45 minutes and an hour per month on CCM services for
each patient, with times ranging between 20 minutes and several hours
per month (81 FR 80244). However, this does not account for the care
management services that are provided beyond one time-based billing
interval and without reaching the next; nor does it account for the
resources involved in maintaining certain advanced primary care
practice capabilities and continuous readiness and monitoring
activities, including patient population monitoring and care needs
assessment, to fully furnish and bill APCM services as is medically
reasonable and necessary for any individual patient during any calendar
month. Finally, this does not account for changes to utilization of
APCM that may occur as a result of the billing and documentation
requirements for APCM services when compared to the current coding and
payment for care management and CTBS services. While our aim is to
value APCM services based on refined assumptions that we believe better
recognize likely utilization of the new proposed codes and the work
required to furnish APCM services, this is challenging without more
information. We welcome comments on ideas for other sources of data
that would help us to assess APCM services valuation.
We considered various alternatives for valuing the APCM services
and how these may impact the broader health care landscape given that
primary care is of such import across the country. We are proposing to
set baseline APCM code values for this first year based on historical
utilization of the care management services we have drawn upon in
designing the APCM codes. We note that utilization of the care
management services has been significantly higher than CTBS, and we
found that CTBS are not typically billed for a patient in the same
month as care management services. It is unclear whether the kinds of
services described by the CTBS are not typically provided during these
months or whether they are being provided but not separately reported.
We will continue to seek information, including from public comments on
this proposed rule, to help us identify the best approach to reflecting
the proposed CTBS elements incorporated into the APCM monthly bundle,
and we are particularly interested in data that could illuminate
differences between what services are furnished and what is being
reported separately. We will continue to consider refinements to the
valuation of APCM codes to reflect available information about changes
in the volume and mix of care management and communication activities
being furnished as part of APCM services in the delivery of advanced
primary care.
For APCM Level 1, we assumed the typical case would involve fewer
resources than the current care management services based upon the
proposed GPCM1 code descriptor and a broad eligible population that
would require limited monthly APCM services; however, it would also
involve certain resources inherent to maintaining advanced primary care
practice capabilities and continuous readiness and monitoring
activities, including patient population monitoring and care needs
assessment, to fully furnish and bill APCM. As described in sections
II.G.2.b. and II.G.2.c. above, certain elements of the APCM service
require resources to maintain continuous readiness and monitoring
activities to furnish covered services consistent with the advanced
primary care model of care. We concluded that the APCM Level 1 services
would be similar in work to that of two billing units of the non-
complex code for CCM services (CPT code 99490 (CCM services provided by
clinical staff per calendar month)) over the course of a year, and
therefore based the proposed inputs on CPT code 99490 multiplied by \1/
6\ (or 2 units over 12 months). Specifically, we proposed a work RVU
for GPCM1 of 0.17, which is the work RVU for CPT code 99490 multiplied
by \1/6\. The resulting proposed PE and MP RVUs are proportionately
similar to those for CPT code 99490 and are available in Addendum B
(see https://www.cms.gov/medicare/payment/prospective-payment-systems/hospital-outpatient/addendum-a-b-updates).\95\ Table 23 displays
payment amount estimates using the 2024 PFS Conversion Factor.
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\95\ https://www.cms.gov/medicare/payment/fee-schedules/physician/federal-regulation-notices?DLSort=2&DLEntries=10&DLPage=1&DLSortDir=descending.
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For APCM Level 2, which describes APCM services to patients with
two or more chronic conditions we assumed the typical, higher intensity
work associated with managing a patient with multiple chronic
conditions would involve significantly more resources and require more,
and more frequent, APCM service elements. We concluded that the APCM
Level 2 services would be similar to current utilization assumptions of
five billing units of the non-complex CCM code (CPT codes 99490) (CCM
services provided by clinical staff per calendar month) and three
billing units of add-on codes annually, given that, for Medicare
beneficiaries who receive these CCM services during a year, the non-
complex CCM base code is billed on average for five months and with
three add-on codes during those 5 months. Additionally, we are
proposing to account for what we believe to be continued
underutilization of CCM services in this patient population by adding
one billing unit of the complex CCM code (CPT code 99490 (CCM services
provided by clinical staff per calendar month) annually. As we noted in
the CY 2020 PFS final rule, ``utilization [of CCM services] has reached
approximately 75 percent of the level we initially assumed under the
PFS when we began paying for CCM services separately under the PFS;
while these are positive results, we believe that CCM services
(especially complex CCM services) continue to be underutilized'', 81 FR
80244 and 84 FR 62688, considering the number of eligible Medicare
beneficiaries. In 2019, approximately 22.6 million FFS beneficiaries
were identified as being potentially eligible for CCM (or 63.4 percent
of the 35.6 million Medicare FFS beneficiaries); however, the use of
CCM services was low among potentially eligible beneficiaries, such
that just 4.0 percent of beneficiaries potentially eligible for CCM
received any CCM services.\96\ Therefore, we based the proposed inputs
on CPT code 99490 multiplied by \5/12\ (or, five units
[[Page 61723]]
over 12 months), plus CPT add-on code 99439 (CCM services each
additional 30 minutes by clinical staff directed by a physician or
other qualified health care professional, per calendar month)
multiplied by \1/6\ (or two units), plus CPT add-on code 99489 (Complex
CCM services each additional 30 minutes by clinical staff directed by a
physician or other qualified health care professional, per calendar
month) multiplied by \1/12\ (one unit), plus CPT code 99487 (Complex
CCM services provided by clinical staff directed by a physician or
other qualified health care professional, per calendar month)
multiplied by \1/12\ (one unit). Specifically, we proposed a work RVU
for GPCM2 of 0.77, which is the sum of the work RVU for CPT codes
99490, 99439, 99489, and 99487 multiplied by their respective
proportions above. The resulting proposed PE and MP RVUs are
proportionately similar and are available in Addendum B (see https://www.cms.gov/medicare/payment/prospective-payment-systems/hospital-outpatient/addendum-a-b-updates).\97\ Table 23 displays payment amount
estimates using the 2024 PFS Conversion Factor.
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\96\ The determination of potential eligibility for CCM was
based on presence of two or more Chronic Condition Warehouse (CCW)
chronic condition flags, one of which was hypertension,
hyperlipidemia, or diabetes. Beneficiaries on Medicare Advantage,
with end stage renal disease (ESRD) or using the hospice benefit
were excluded. ASPE. Analysis of 2019 Medicare Fee-for-Service (FFS)
Claims for Chronic Care Management (CCM) and Transitional Care
Management (TCM) Services. March 2022. https://aspe.hhs.gov/sites/default/files/documents/31b7d0eeb7decf52f95d569ada0733b4/CCM-TCM-Descriptive-Analysis.pdf.
\97\ https://www.cms.gov/medicare/payment/fee-schedules/physician/federal-regulation-notices?DLSort=2&DLEntries=10&DLPage=1&DLSortDir=descending.
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For APCM Level 3 (HCPCS code GPCM3), which describes APCM services
to patients with QMB status and two or more chronic conditions, we are
proposing to value the service as a relative increase to the valuation
of APCM Level 2 based on recent Medicare expenditure data for dually
eligible Medicare beneficiaries. In CY 2021, per person per year
spending on dually eligible beneficiaries was $24,370 and for non-
dually eligible beneficiaries was $11,172. The difference between these
two amounts is 218 percent. We have considered the likely resource
demands and intensity of the practitioner-patient interaction for this
patient population, consistent with our coding and valuation policies
that reflect variations in resource cost and patient-centered care
delivery policies.\98\ By taking into consideration the difference in
Medicare spending on a per person per year basis between dually
eligible and non-dually eligible Medicare beneficiaries, we believe
that we can capture the increased resources involved in furnishing APCM
services to patients with QMB status and multiple chronic conditions.
Therefore, we based the proposed inputs for the APCM Level 3 code on
the APCM Level 2 inputs multiplied by 218 percent. Specifically, we
proposed a work RVU for GPCM3 of 1.67, which is the proposed work RVU
for GPCM2 multiplied by 218 percent. The resulting proposed PE and MP
RVUs are proportionately similar to those and are available in Addendum
B (see https://www.cms.gov/medicare/payment/prospective-payment-systems/hospital-outpatient/addendum-a-b-updates).\99\ Table 23
displays payment amount estimates using the 2024 PFS Conversion Factor.
---------------------------------------------------------------------------
\98\ https://www.macpac.gov/wp-content/uploads/2024/01/Jan24_MedPAC_MACPAC_DualsDataBook-508.pdf.
\99\ https://www.cms.gov/medicare/payment/fee-schedules/physician/federal-regulation-notices?DLSort=2&DLEntries=10&DLPage=1&DLSortDir=descending.
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Table 23 includes the proposed placeholder codes (which, if
finalized, will be replaced with numeric G-codes announced in the final
rule), short descriptors, crosswalk codes, proposed RVUs (work, PE, and
MP), and approximate payment rate. For illustration purposes, we
multiplied the proposed APCM relative values for work, practice expense
(PE), and malpractice (MP), without geographic adjustment, by the CY
2024 conversion factor (CF) ($32.7442) to convert the proposed relative
value units (RVUs) into approximate national payment rates.
[GRAPHIC] [TIFF OMITTED] TP31JY24.047
We are seeking feedback on whether these proposed values
appropriately reflect the resource costs involved in furnishing these
services, or whether adjustments to the proposed values or additional
coding may be needed. We are broadly interested in public comments and
input from interested parties on potential refinements in code and
service definitions, including how we might refine our utilization
assumptions for these codes, and other important information involving
coding and payment for APCM services to better reflect the current
practice of advanced primary care, including elements of CTBS and care
management services. We are interested in developing a better
understanding of the resource costs involved in furnishing
comprehensive care management as part of advanced primary care to
various patient populations, including specifically QMBs.
We intend to engage in further discussions with the public over the
next several years to potentially refine our policies for 2025 and
future years, and we expect that having APCM utilization data, once the
proposed codes are established, would inform future refinement of the
valuations for these codes.
Finally, as described in the Advanced Primary Care RFI that
follows, we note that there is potential for the valuation of these
codes and future related codes to change and/or scale into larger units
if we expand them to incorporate more
[[Page 61724]]
service elements (see section II.G.3. of this proposed rule). As we
receive more information about how these codes are being used and
implemented in medical practice, we anticipate that these codes and
future related codes will be refined over time. We note that the
development of payment and coding policies for these and other kinds of
services under the PFS is typically an iterative process that responds
to changes in medical practice and may be best refined over several
years through annual rulemaking for the PFS, and through the
development of CPT codes by the AMA's CPT Editorial Committee.
As described in the next section, we believe that this new proposed
APCM code set could serve as a chassis to incorporate primary care
model learnings over time under the PFS and an additional pathway to
accountable care for primary care practitioners.
3. Request for Information: Advanced Primary Care Hybrid Payment
a. Background
Recent evidence reviews show that while primary care is the only
part of the health system in which investments routinely result in not
only improved outcomes but also increased equity,\100\ the practice and
sustainability of the primary care sector is under significant
strain.\101\ The NASEM found that many of these challenges relate to a
primary care payment system that principally rewards visit volume
versus creation and maintenance of longitudinal \102\ care
relationships over time.\103\ We have set a goal of having 100 percent
of traditional Medicare beneficiaries and the vast majority of Medicaid
beneficiaries in accountable care relationships by 2030. Accountable
care occurs when a person-centered care team takes responsibility for
improving quality of care, care coordination and health outcomes for a
defined group of individuals, to reduce care fragmentation and avoid
unnecessary costs for individuals and the health system.\104\ Advanced
primary care is a core mechanism for achieving this goal. With this
goal, we acknowledge the need to increase the capability of primary
care clinicians to engage, maintain, and promote longitudinal and
accountable relationships with beneficiaries through incentives and
flexibilities to manage quality and total cost of care.
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\100\ National Academies of Sciences, Engineering, and Medicine
(NASEM); Implementing High-Quality Primary Care (https://nap.nationalacademies.org/read/25983).
\101\ Milbank Memorial Fund, The Health of US Primary Care: 2024
Scorecard (https://www.milbank.org/wp-content/uploads/2024/02/Milbank-Scorecard-2024-ACCESS_v06.pdf).
\102\ Longitudinal care management is long-term, proactive,
relationship-based care management that augments routine and acute
visits with intentional, proactive outreach, especially during times
of illness and transitions of care.
\103\ NASEM, Implementing High-Quality Primary Care (https://nap.nationalacademies.org/read/25983).
\104\ https://www.cms.gov/priorities/innovation/key-concepts/accountable-care-and-accountable-care-organizations.
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Over the past 11 years, the CMS Innovation Center has tested a
number of primary care models: CPC, CPC+, Maryland Primary Care
Program, PCF, as well as the upcoming MCP and ACO Primary Care Flex.
Each of these primary care models has focused on testing what happens
when we pay for primary care services with hybrid payments (a mix of
fee-for-service and population-based payments), as described earlier.
While these models have not met the criteria for expansion to date, the
findings suggest advanced primary care may reduce unnecessary
utilization and improve diabetes care and cancer screening rates.
In addition to testing new approaches to improve care for
beneficiaries by supporting primary care, we have focused on approaches
to incorporating these innovations into Medicare programs. For example,
lessons learned from the CMS Innovation Center's ACO models may be
incorporated into the Shared Savings Program. As such, part of the
intent of our proposal to create new APCM payment and coding is that we
would have a similar foundation to scale advanced primary care model
learnings over time.
Previous Innovation Center primary care model tests have helped us
learn lessons to inform our current and future work. For example,
participants in primary care models have indicated difficulty investing
in and maintaining primary care redesign activities due to a range of
challenges. First, additional non-visit-based primary care payments
have been generally layered upon base payments still predominantly FFS
in structure. As such, the incentives and abilities of practices to
focus on proactive, population-based non-visit activities may be
limited if the funding stream for these activities is limited in scope
and duration.105 106 (Examples of non-visit-based activities
include, but are not limited to: activities to improve care
coordination, implement data-driven quality improvement, or enhance
targeted care management for beneficiaries identified as high-risk.)
Further, model funding for the clinical and administrative staff needed
to accomplish advanced primary care coordination and population health
functions is contingent on continued participation in these
models.\107\ Once the models end, practices are left without the
funding that they received under the models for the clinical and
administrative staff that had supported population health functions
under the model. Moreover, because these models involve additional
payments tied to performance rather than changes to base primary care
payment, practices report that the funding they use to support non-
visit activities is sometimes received well after the non-visit
services have occurred, leading to further challenges sustaining these
efforts fiscally. Solving these challenges is a key goal of future
Innovation Center model work.\108\
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\105\ Independent Evaluation of Comprehensive Primary Care Plus
(CPC+): Final Report. https://www.cms.gov/priorities/innovation/data-and-reports/2023/cpc-plus-fifth-annual-eval-report.
\106\ Schurrer J, Timmins L, Gruszczynski M, et al. Evaluation
of the Primary Care First Model: Second Annual Report. Mathematica.
February 2024. https://www.cms.gov/priorities/innovation/data-and-reports/2024/pcf-second-eval-rpt.
\107\ CMS defines population health as health behaviors and
outcomes of a broad group of individuals, including the distribution
of such outcomes affected by the contextual factors within the
group.
\108\ https://www.cms.gov/about-cms/what-we-do/cms-strategic-plan.
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To strengthen the primary care infrastructure within FFS Medicare,
we are exploring opportunities to create new sustainable pathways to
support advanced primary care, equitable access to high-quality primary
care, and continued transformation among a wide variety of practices.
One potential strategy to increase access to advanced primary care and
prepare practitioners in traditional Medicare to engage in more
accountable care is through the creation and ongoing refinement of
specific billing and coding under the PFS that better recognizes
advanced primary care and incorporates the resources involved in
furnishing longitudinal care and maintaining relationships with
patients over time. In section II.G.2. of this proposed rule, we are
proposing a set of APCM services that make use of lessons learned from
the CMS Innovation Center's primary care models, grouping existing care
management and CTBS service elements into a bundle for use starting in
CY 2025.
We are seeking feedback regarding potential further evolution in
coding and payment policies to better recognize advanced primary care.
Through this Advanced Primary Care RFI, we are committed to
collaborating with
[[Page 61725]]
interested parties to lay the path for a more transparent movement to
value-based care. Specifically, we are requesting input on a broader
set of questions related to care delivery and incentive structure
alignment and five foundational components:
Streamlined Value-Based Care Opportunities
Billing Requirements
Person-Centered Care
Health Equity, Clinical, and Social Risk
Quality Improvement and Accountability
We encourage input on the questions below from diverse voices,
including beneficiaries and advocates, community-based organizations,
providers, clinicians, researchers, unions, and all other interested
parties.
b. Solicitation of Public Comments
We are seeking feedback regarding potential changes to coding and
payment policies for advanced primary care services to be incorporated
in traditional Medicare. For example, in the future, coding for APCM
services (proposed in section II.G.2. of this proposed rule) could be
revised to include additional service elements, including traditional
E/M services. This Advanced Primary Care RFI is designed to solicit
feedback on how we can further the goals of reducing administrative
burden to refocus time on patient care; better recognizing the relative
resources involved in furnishing care; recognizing interdisciplinary,
team-based primary care; and supporting primary care sustainability and
stability (especially for underserved communities). Whenever possible,
respondents are requested to draw their responses from objective,
empirical, and actionable evidence and to cite this evidence within
their responses. We anticipate potential changes to primary care coding
and payment policies, such as use of coding that recognizes groups of
services furnished over a fixed time period, that would offer a new
opportunity within the PFS for primary care clinicians to move to
payment structures that are not fully dependent on billing for each
discrete component of overall care and act as a step toward
accountability for the cost and quality of patient care. Therefore, we
are seeking feedback on building advanced primary care payment
mechanisms that create pathways to recognize how primary care practice
has moved away from an encounter-based orientation toward population-
based care. This Advanced Primary Care RFI is the first step in
ensuring ample opportunity for public input, followed by notice and
comment rulemaking in subsequent years.
(1) Streamlined Value-Based Care Opportunities
We are seeking to create a steppingstone for primary care
clinicians, including those new to value-based care, to move away from
either encounters or other discrete components of overall care as the
dominant method of primary care payment and toward payments in larger
units that are better tied to the relative resource costs involved in
population-based, longitudinal care. Feedback from interested parties
has been helpful when considering how to scale the availability of
payments into larger units, and incorporate population-based
variability in resources, all while driving toward accountability, and
person-centered care. Ultimately, to create more opportunities for
beneficiaries to receive high-quality, accountable primary care, we are
focused on creating multiple pathways to recognize delivery of
integrated care across settings, and engagement in comprehensive, team-
based, longitudinal care.
When considering the evolution of a hybrid payment system within
the PFS, we seek input on the following questions:
How can CMS better support primary care clinicians and
practices who may be new to population-based and longitudinal care
management?
What are the primary barriers to providing particular
strategies or supports needed for pediatric clinicians and practices?
How can CMS ensure that potential future advanced primary
care payment will not induce clinicians to leave effective accountable
care relationships and clinician networks that already produce positive
results? Additionally, how can CMS support growth over time in existing
effective accountable care relationships and clinician networks?
Should CMS evolve the proposed APCM services into an
advanced primary care payment that includes E/M and other relevant
services, or maintain a separate code set for APCM?
If E/M services are bundled together for advanced primary
care payments, how can CMS ensure that there is not a disincentive for
primary care clinicians to continue to provide E/M visits, or increase
accountability to E/M visits as warranted?
As many codes depend on E/M visits (for example, as the
base code for an add-on code, or to initiate specific care management
activities), how should CMS consider the downstream impacts of
incorporating E/M visits into advanced primary care payments?
Should CMS consider incorporating other CTBS services into
advanced primary care hybrid payments, such as Remote Physiologic
Monitoring and/or Remote Therapeutic Monitoring?
Should CMS consider incorporating other services that
involve comprehensive care management and care coordination, such as
Behavioral Health Integration, End-Stage Renal Disease Monthly
Capitation Payment (ESRD MCP), Assessment/Care Planning for Cognitive
Impairment, and/or Advance Care Planning?
Should CMS consider incorporating other services while the
patient is under care of home health agencies or hospices, such as Care
Plan Oversight?
Newly finalized HCPCS codes are eligible for use by other
payers, including commercial insurers, state Medicaid agencies, and
others. We note that value-based alignment is a key goal of CMS. If the
APCM codes are finalized, they would be eligible for use by these other
payers as well. To what extent are other payers interested in adopting
the APCM codes? Are there any other changes that would be necessary for
other payers to adopt the codes?
CMS has historically used information presented by the
Relative Value Scale Update Committee to determine PFS payment rates.
Are there other sources of data on the relative value of primary care
services that CMS should consider when setting hybrid payment rates?
(2) Billing Requirements
Previous CMS Innovation Center primary care models have provided
key lessons learned about how to increase comfort with population-based
payments, the importance of reducing the administrative burden of
billing, and how to begin addressing gaps in equitable access to
population-based payments.\109\ Specifically, we have learned through
Innovation Center initiatives that retrospective reconciliation or
adjustment of payments for services rendered can be especially
frustrating for practitioners, as it reduces the predictability and
stability of payments.\110\
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\109\ Independent Evaluation of Comprehensive Primary Care Plus
(CPC+): Final Report. https://www.cms.gov/priorities/innovation/data-and-reports/2023/cpc-plus-fifth-annual-eval-report; Independent
Evaluation of Primary Care First: Second Annual Report. https://www.cms.gov/priorities/innovation/data-and-reports/2024/pcf-second-eval-rpt.
\110\ Independent Evaluation of Primary Care First: Second
Annual Report. https://www.cms.gov/priorities/innovation/data-and-reports/2024/pcf-second-eval-rpt.
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[[Page 61726]]
For these reasons, we are seeking to understand how advanced
primary care hybrid payments can balance program integrity, high-
quality care, payment stability, and clinician burden.
We seek input on the following questions:
How can CMS reduce the potential burden of billing for
population-based and longitudinal care services?
Are there particular types of items or services that
should be excluded from the advanced primary care bundle?
Are there particular services paid under the PFS today
that should be included in the advanced primary care bundle?
Care management activities are currently billed monthly.
What episode lengths should CMS consider when thinking about an
advanced primary care bundle of services for hybrid payment? Include
evidence to support the proposed episode length.
Should CMS attribute the advanced primary care clinical
episode to a single clinician, or consider weighted attribution and
payment for multiple entities or clinicians? How could weighted
attribution and payment work? What rules or processes should CMS
consider to attribute the episode?
Care management coding and payment have historically
required an initiating visit prior to starting monthly billing, to
ensure that the services are medically reasonable and necessary and
consistent with the plan of care. Are there other ways that CMS could
ensure the clinician billing APCM is responsible for the primary care
of the Medicare beneficiary?
Care management coding and payment require beneficiary
cost sharing. Has beneficiary cost sharing been a barrier to
practitioners providing such services?
Consistent with the initiating visit requirement in the
APCM proposal, should CMS require the billing of specific qualifying
services for billing of an advanced primary care bundle that is larger
in scale and scope than APCM?
Are there Health IT functions beyond what is proposed for
APCM services that clinicians should be required to have to bill for an
advanced primary care bundle? What should CMS consider in the design of
the advanced primary care bundle to effectively incorporate Health IT
standards and functionality, to support interoperability and the aims
of advanced primary care?
Should CMS limit the types of non-physician clinicians
that can bill for an advanced primary care bundle that is larger in
scale and scope than APCM? If so, include evidence to support the
restriction.
How should CMS reconcile instances where an advanced
primary care bundle is billed, but primary care services are then
billed for and provided by separate entities?
(3) Person-Centered Care
Person-centered care integrates individuals' clinical needs across
providers and settings, while addressing their social needs.\111\ We
strive for better, more affordable care and improved health outcomes.
Key to this mission are care innovations that empower beneficiaries and
clinicians, while reducing the administrative burden of providing
episode-based and longitudinal care management. We are seeking comment
on how an advanced primary care code(s) could be structured to both
increase efficiency and promote the use of high-value services.
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\111\ CMS White Paper on CMS Innovation Center's Strategy:
Driving Health System Transformation--A Strategy for the CMS
Innovation Center's Second Decade (https://www.cms.gov/priorities/innovation/strategic-direction-whitepaper).
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We seek input on the following questions:
What activities that support the delivery of care that is
coordinated across clinicians, support systems, and time should be
considered for payment in an advanced primary care bundle that are not
currently captured in the PFS?
How can CMS structure advanced primary care hybrid
payments to improve patient experience and outcomes?
How can CMS structure advanced primary care hybrid
payments to ensure appropriate access to telephonic and messaging
primary care services?
What is the best reporting structure to ensure that
targeted services are delivered without causing undue or excessive
documentation?
How can CMS facilitate coordination between primary care
clinicians that bill for advanced primary care bundles and specialists
to reduce costs and improve patient outcomes?
(4) Health Equity, Social and Clinical Risk
We define health equity as, ``the attainment of the highest level
of health for all people, where everyone has a fair and just
opportunity to attain their optimal health regardless of race,
ethnicity, disability, sexual orientation, gender identity,
socioeconomic status, geography, preferred language, or other factors
that affect access to care and health outcomes.'' \112\ The CMS
Framework for Health Equity lays out how we are working to advance
health equity by designing, implementing, and operationalizing policies
and programs that support health for all the people served by our
programs, eliminating avoidable differences in health outcomes
experienced by people who are disadvantaged or underserved, and
providing the care and support that our beneficiaries need to
thrive.\113\ For advanced primary care hybrid payments, this may mean
incorporating different types of social and clinical risk into the
payment than have typically been considered in traditional E/M or care
management codes.
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\112\ https://www.cms.gov/pillar/health-equity.
\113\ Centers for Medicare & Medicaid Services, The CMS
Framework for Health Equity (2022-2032). April 2022. https://www.cms.gov/files/document/cms-framework-health-equity-2022.pdf.
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Recent models such as ACO REACH \114\ and Making Care Primary \115\
have incorporated risk adjustment for social risk factors, such as Part
D Low Income Subsidy enrollment status and Area Deprivation Index, to
better capture factors relevant to care of the patient. We seek input
on how advanced primary care billing and payment policy could be used
to reduce health disparities and social risk. Furthermore, we are
seeking to balance a simple payment structure that encourages the
uptake of advanced primary care services, while ensuring that the risk
adjustment method used to develop the payment rates incentivizes the
appropriate coding of patient conditions and needs, including those
that have previously been under-documented, such as dementia and
patient frailty.\116\
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\114\ https://www.cms.gov/priorities/innovation/innovation-models/aco-reach.
\115\ https://www.cms.gov/priorities/innovation/innovation-models/making-care-primary.
\116\ National Academies of Sciences, Engineering, and Medicine
(NASEM); Committee on the Decadal Survey of Behavioral and Social
Science Research on Alzheimer's Disease and Alzheimer's Disease-
Related Dementias. Reducing the Impact of Dementia in America: A
Decadal Survey of the Behavioral and Social Sciences. National
Academies Press. July 26, 2021. https://nap.nationalacademies.org/catalog/26175/reducing-the-impact-of-dementia-in-america-a-decadal-survey.
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We seek input on the following questions:
What non-claims-based indicators could be used to improve
payment accuracy and reduce health disparities, and how can CMS ensure
that they are collected uniformly and documented consistently without
unduly increasing administrative burden?
What risk factors, including clinical or social, should be
considered in developing payment for advanced primary care services?
[[Page 61727]]
How can CMS account for apparent changes in risk that are
due to changes in coding patterns rather than changes in health status?
What risk adjustments should be made to proposed payments
to account for higher costs of traditionally underserved populations?
What indicators are used to capture added social risk in
commercial insurance? Should CMS consider using these?
What metrics should be used or monitored to adjust payment
to ensure that health disparities are not worsened as an unintended
consequence?
How can CMS ensure that advanced primary care hybrid
payment increases access to health care services for patients without a
usual source of primary care?
Are there steps CMS can take to ensure advanced primary
care billing and coding is utilized for dually eligible beneficiaries,
and by safety net providers?
Should CMS incorporate Community Health Integration and/or
Principal Illness Navigation services and payment into an advanced
primary care bundle?
(5) Quality Improvement and Accountability
We are committed to affordable quality health care for all people
with Medicare. We seek feedback regarding how we can continue to
strengthen beneficiary access to high-quality health services within
FFS Medicare. One goal of the CMS Innovation Center Strategy Refresh is
to increase the capability of practitioners furnishing advanced primary
care to engage in accountable care relationships with beneficiaries
through incentives and flexibilities to manage clinical quality,
outcomes, patient experience, and total cost of care. As such, part of
the intent of evolving and creating over time advanced primary care
hybrid payments is that the practitioners who bill for these services
are engaged in a relationship where they are responsible for the
quality and cost of care for the beneficiary, counting toward the
overall 2030 goal of every person with Traditional Medicare being in an
accountable care relationship. This Advanced Primary Care RFI seeks
input from beneficiaries and their caregivers, primary care and other
clinicians, and health plans on how advanced primary care bundles could
support that goal.
We seek input on the following questions:
How can CMS ensure clinicians will remain engaged and
accountable for their contributions to managing the beneficiary's care?
What are key patient-centered measures of quality,
outcomes and experience that would help ensure that hybrid payment
enhances outcome and experience for patients?
How could measures of quality, outcomes, and experience
guard against and decrement in access or quality?
As described in the APCM proposal, reporting of the
``Value in Primary Care'' MVP would be an APCM service element for MIPS
eligible clinicians beginning in 2026. Since this MVP contains measures
focused on both the total cost and quality of care, would its inclusion
as an APCM service element be sufficient to count as ``accountable
care?'' If not, what other service delivery or quality reporting would
be expected in ``accountable care?''
What should CMS consider so that that advanced primary
care bundles could be used to promote accountable care across payers,
both commercial and Medicaid?
What quality measures are other payers using to drive
improvements in primary care?
What utilization measures are other payers using to drive
improvements in primary care?
What patient experience measures are other payers using to
drive improvements in primary care?
Should CMS consider flexibilities for smaller practices to
bill the advanced primary care bundle? Should CMS consider
flexibilities for entities exempt from MIPS to bill the advanced
primary care bundle?
Would clinicians be willing to take on more accountability
to further reduce the frequency and/or administrative burden of
billing?
For APCM services, are there other key practice-level
elements of the service that should be considered for advanced primary
care practices to bill for advanced primary care?
4. Cardiovascular Risk Assessment and Risk Management
a. Background
Cardiovascular disease (CVD) is a leading cause of death,
disability, and health care expenditures in the U.S.\117\ The burden of
CVD is unequal, with black Americans experiencing higher rates of CVD-
related morbidity than white Americans.\118\ Atherosclerotic CVD \119\
is also distinct among leading causes of death for Americans in the
proportion of CVD attributable to behavioral causes,\120\ making
improvement in modifiable CVD risk factors (for example, diet,
exercise, smoking cessation) is a key treatment target to reduce the
burden of CVD across populations.\121\
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\117\ Heart Disease and Stroke Statistics--2023 Update: A Report
from the American Heart Association Connie W. Tsao, MD, MPH, FAHA
et. al. Circulation. 2023;147:e93-e621.
\118\ Cardiovascular Health in African Americans: A Scientific
Statement From the American Heart Association Mercedes R. Carnethon,
Ph.D., FAHA et al. Circulation. 2017;136:e393-e423.
\119\ What is Atherosclerosis? NIH NHLBI. https://www.nhlbi.nih.gov/health/atherosclerosis.
\120\ Libby, P., Buring, J.E., Badimon, L. et al.
Atherosclerosis. Nat Rev Dis Primers 5, 56 (2019). https://doi.org/10.1038/s41572-019-0106-z.
\121\ Ebrahim S, Taylor F, Ward K, Beswick A, Burke M, Davey
Smith G. Multiple risk factor interventions for primary prevention
of coronary heart disease. Cochrane Database Syst Rev.
2011;(1):CD001561 https://pubmed.ncbi.nlm.nih.gov/21249647/.
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The CMS Innovation Center's Million Hearts[supreg] Cardiovascular
Disease (CVD) Risk Reduction model \122\ (hereafter referred to as
Million Hearts[supreg] model) was launched in 2017 as part of the
ongoing HHS Million Hearts[supreg] Initiative.\123\ The model's goals
were to decrease the incidence of first-time heart attacks and strokes
among medium and high-risk Medicare beneficiaries over five years and
reduce Medicare spending on cardiovascular events. The model was
implemented as a randomized design where participant organizations in
the intervention group agreed to (1) calculate traditional Medicare
beneficiaries' risk of having a heart attack or stroke over 10 years,
and (2) provide cardiovascular care management services to high-risk
patients (defined as a risk of a cardiovascular event in the next
decade of greater than thirty percent). The model also identified
medium-risk patients (more than fifteen percent risk of an event in the
next decade) in its evaluation. In exchange for doing so, CMS paid
participant organizations $10 for each eligible traditional Medicare
beneficiary for whom the organizations assessed risk, and in the first
year of the model, $10 for each high-risk beneficiary during each month
when cardiovascular care management services were provided.\124\ In
[[Page 61728]]
subsequent years of the model (2018 to 2022) participants were expected
to reassess cardiovascular risk and were paid based on cardiovascular
risk reduction ($0 to $10 per beneficiary per month) for high-risk
beneficiaries.
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\122\ Sanghavi DM, Conway PH. Paying for prevention: a novel
test of Medicare value-based payment for cardiovascular risk
reduction. JAMA. 2015;314(2):123-124. https://jamanetwork.com/journals/jama/fullarticle/2300705.
\123\ Frieden TR, Berwick DM. The ``Million Hearts'' initiative:
preventing heart attacks and strokes. N Engl J Med.
2011;365(13):e27. https://pubmed.ncbi.nlm.nih.gov/21913835/.
\124\ Blue L, Kranker K, Markovitz AR, et al. Effects of the
Million Hearts Model on Myocardial Infarctions, Strokes, and
Medicare Spending: A Randomized Clinical Trial. JAMA.
2023;330(15):1437-1447. doi:10.1001/jama.2023.19597.
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All CMS Innovation Center models are independently evaluated \125\
and the evaluation of the Million Hearts[supreg] model found the model
reduced the rate of death from any cause for medium and high-risk
beneficiaries by four percent, as well as reduced the risk of death
from a cardiovascular event (that is, heart attack or stroke) by eleven
percent.\126\ We consider this to be due to increased rates of
cardiovascular risk assessment, discussion of cardiovascular risk by
participants' clinicians, and the use of appropriate medications to
reduce cardiovascular risk (for example, aspirin and statins).\127\
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\125\ Evaluation of the Million Hearts Cardiovascular Disease
Risk Reduction Model. Final Report. August 2023. Mathematica.
https://www.cms.gov/priorities/innovation/data-and-reports/2023/mhcvdrrm-finalannevalrpt.
\126\ Evaluation of the Million Hearts Cardiovascular Disease
Risk Reduction Model, p. 43. Final Report. August 2023. Mathematica.
https://www.cms.gov/priorities/innovation/data-and-reports/2023/mhcvdrrm-finalannevalrpt.
\127\ Evaluation of the Million Hearts Cardiovascular Disease
Risk Reduction Model, p. 26. Final Report. August 2023. Mathematica.
https://www.cms.gov/priorities/innovation/data-and-reports/2023/mhcvdrrm-finalannevalrpt.
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During the Million Hearts[supreg] (MH) model (which was tested from
2017-2022), there was a recently-introduced ASCVD risk assessment tool
to incorporate demographic (age, sex, race), clinical (blood pressure,
cholesterol, history of diabetes), and risk behavior (smoking status,
use of anti-hypertensives, use of statins, use of aspirin) established
by the American College of Cardiology (ACC),\128\ as well as a
longitudinal re-assessment tool used within the model.\129\ This tool
calculated the 10-year risk of a cardiovascular event for beneficiaries
ages 40-79. Subsequently, additional ASCVD risk assessment tools have
been developed.\130\
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\128\ Grundy SM, Stone NJ, Bailey AL, Beam C, Birtcher KK,
Blumenthal RS, Braun LT, de Ferranti S, Faiella-Tommasino J, Forman
DE, Goldberg R, Heidenreich PA, Hlatky MA, Jones DW, Lloyd-Jones D,
Lopez-Pajares N, Ndumele CE, Orringer CE, Peralta CA, Saseen JJ,
Smith SC, Sperling L, Virani SS, Yeboah J. 2018 ACC guideline on the
management of blood cholesterol: a report of the American College of
Cardiology Foundation/American Heart Association Task Force on
Clinical Practice Guidelines. J Am Coll Cardiol. 2018. https://tools.acc.org/ldl/ascvd_risk_estimator/#!/calulate/estimator/.
\129\ Lloyd-Jones DM, Huffman MD, Karmali KN, Sanghavi DM,
Wright JS, Pelser C, Gulati M, Masoudi FA, Goff DC Jr. Estimating
Longitudinal Risks and Benefits From Cardiovascular Preventive
Therapies Among Medicare Patients: The Million Hearts Longitudinal
ASCVD Risk Assessment Tool: A Special Report From the American Heart
Association and American College of Cardiology. Circulation. 2017
Mar 28;135(13):e793-e813.
\130\ Leading Cardiologists reveal new cardiovascular disease
prevention risk calculator. https://newsroom.heart.org/news/leading-
cardiologists-reveal-new-heart-disease-risk-
calculator#:~:text=The%20American%20Heart%20Association%20PREVENT,CKM
%20syndrome%20into%20CVD%20prevention.
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Today in clinical practice, ASCVD risk is generally calculated
using a tool combining demographic data, personal history (risk
behaviors and medical history), and laboratory data (lipid panel).\131\
This information is used to calculate into a 10-year estimate of a
patient's ASCVD risk for use in determining treatment advice provided
by the treating practitioner. This determination requires both data
collection at a visit and laboratory data, which may not be available
at an initial visit. This change in clinical practice occurred over
time after a series of guidelines from the American Heart Association
(AHA) recommended using ASCVD risk in determining treatment decisions
for patients without a prior history of CVD.\132\ This treatment
guideline also includes recommendations for lifestyle modifications for
all patients. The CMS Innovation Center Million Hearts[supreg] model
contributed to this change in clinical practice by demonstrating
through a rigorous randomized control trial that the quantitative
assessment of 10-year cardiovascular risk improves quality of care,
including mortality, compared to prior practice.\133\
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\131\ 2019 ACC/AHA Primary Prevention of Cardiovascular Disease.
https://www.ahajournals.org/doi/pdf/10.1161/CIR.0000000000000678.
\132\ Arnett DK et al. 2019 ACC/AHA Guideline on the Primary
Prevention of Cardiovascular Disease: A Report of the American
College of Cardiology/American Heart Association Task Force on
Clinical Practice Guidelines. Circulation. 2019 Sep 10;140(11):e596-
e646. doi: 10.1161/CIR.0000000000000678.
\133\ Blue L, Kranker K, Markovitz AR, et al. Effects of the
Million Hearts Model on Myocardial Infarctions, Strokes, and
Medicare Spending: A Randomized Clinical Trial. JAMA.
2023;330(15):1437-1447. doi:10.1001/jama.2023.19597.
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In the Million Hearts[supreg] model, cardiovascular-focused care
management services included an initiating visit where an ASCVD risk
assessment is performed, structured recording of patient health
information using CEHRT, and a comprehensive care plan focused on
cardiovascular risk reduction (including the ABCS focused on in the
Million Hearts[supreg] model), but did not require 24/7 access to care,
management of care transitions, or home and community-based
coordination because these services are necessary for the management of
complex conditions placing a beneficiary at high risk of death, acute
exacerbation/decompensation, or functional decline, and these services
are provided to prevent the development of these complex chronic
conditions. In the Million Hearts[supreg] model, cardiovascular-focused
risk management services were provided to beneficiaries at high risk
for CVD (more than a thirty percent risk of a cardiovascular event in
the next 10 years).
We interpret the findings of the Million Hearts[supreg] model to be
both reflective of and perhaps augmenting an evolution in clinical
practice toward quantitative ASCVD risk assessment. We also do not
believe the resources involved in these activities are appropriately
reflected in current coding and payment policies. As such, we are
proposing to establish codes to describe a separately billable
cardiovascular disease risk assessment that is furnished in conjunction
with an E/M visit and cardiovascular-focused risk management, when
reasonable and necessary due to the presence of increased
cardiovascular risk factors identified for the individual patient.
b. ASCVD Risk Assessment
We are proposing a new stand-alone G-code, HCPCS code GCDRA,
Administration of a standardized, evidence-based Atherosclerotic
Cardiovascular Disease (ASCVD) Risk Assessment for patients with ASCVD
risk factors on the same date as an E/M visit, 5-15 minutes, not more
often than every 12 months. Atherosclerotic Cardiovascular Disease
(ASCVD) Risk Assessment refers to a review of the individual's
demographic factors, modifiable risk factors for CVD, and risk
enhancers for CVD. We are proposing this new code to identify and value
the work involved in administering an ASCVD risk assessment when
medically reasonable and necessary in relation to an E/M visit.
We further propose that the ASCVD risk assessment must be furnished
by the practitioner on the same date they furnish an E/M visit, as the
ASCVD risk assessment would be reasonable and necessary when used to
inform the patient's diagnosis, and treatment plan established during
the visit. ASCVD risk assessment is reasonable and necessary for a
patient who has at least one predisposing condition to cardiovascular
disease that may put them at increased risk for future ASCVD diagnosis.
These conditions could include but are not limited to, obesity, a
family history of CVD, a history of high blood pressure, a history of
high cholesterol, a history of smoking/
[[Page 61729]]
alcohol/drug use, pre-diabetes, or diabetes. We further propose that
the ASCVD risk assessment would not be separately billable for patients
with a cardiovascular disease diagnosis or those who have history of a
heart attack or stroke.
We are not proposing any specific tool that would have to be used
for the ASCVD risk assessment, although the assessment tool must be
standardized and evidence-based. Proposed elements of the ASCVD risk
assessment service would include:
Current (from the last 12 months) laboratory data (lipid
panel) for inputs needed for the risk assessment tool.
Administration of a standardized, evidence-based ASCVD
risk assessment tool that has been tested and validated through
research, and includes the following domains:
++ The output of the tool must include a 10-year estimate of the
patient's ASCVD risk. This output must be documented in the patient's
medical record.
++ Demographic factors (such as age, sex).
++ Modifiable risk factors for CVD (such as blood pressure &
cholesterol control, smoking status/history, alcohol and other drug
use, physical activity and nutrition, obesity).
++ Possible risk enhancers (such as pre-eclampsia, pre-diabetes,
family history of CVD).
++ Billing practitioners may choose to assess for additional
domains beyond those listed above if the tool used requires additional
domains. Examples of tools include but are not limited to, the ACC
ASCVD Risk Estimator \134\ and the ACC PREVENT tool.\135\ CMS expects
that the tool that is used would not introduce discriminatory bias,
consistent with Section 1557 final rule.
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\134\ Lloyd-Jones DM, Huffman MD, Karmali KN, Sanghavi DM,
Wright JS, Pelser C, Gulati M, Masoudi FA, Goff DC Jr. Estimating
Longitudinal Risks and Benefits From Cardiovascular Preventive
Therapies Among Medicare Patients: The Million Hearts Longitudinal
ASCVD Risk Assessment Tool: A Special Report From the American Heart
Association and American College of Cardiology. Circulation. 2017
Mar 28;135(13):e793 e813.
\135\ Leading Cardiologists reveal new cardiovascular disease
prevention risk calculator. https://newsroom.heart.org/news/leading-
cardiologists-reveal-new-heart-disease-risk-
calculator#:~:text=The%20American%20Heart%20Association%20PREVENT,CKM
%20syndrome%20into%20CVD%20prevention.
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We are proposing for HCPCS code GCDRA to have a duration of 5-15
minutes for the administration of an ASCVD risk assessment tool, billed
no more often than once every 12 months.
We are requesting comments on these proposals, as well as
information pertaining to potential clinician education for these
proposed codes.
(1) Proposed Valuation for ASCVD Risk Assessment GCDRA
We propose a direct crosswalk to HCPCS Code G0136 (Administration
of a standardized, evidence-based SDOH assessment, 5-15 minutes, not
more often than every 6 months), with a work RVU of 0.18 as we believe
this service reflects the resource costs associated when the billing
practitioner performs the service described. HCPCS code G0136 has an
intra-service time of 15 minutes, and the physician work is of similar
intensity to proposed HCPCS code GCDRA. Therefore, we are proposing a
work time of 15 minutes for HCPCS code GCDRA based on this same
crosswalk to G0136. We are also proposing to use this crosswalk to
establish the direct PE inputs for HCPCS code GCDRA.
We are seeking comments on these proposals.
c. Atherosclerotic Cardiovascular Disease Risk Management Services
(GCDRM)
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 healthcare
professionals, especially in the context of evolving changes in medical
practice using evidence-based models of care, such as the Million
Hearts[supreg] model. We are proposing to establish a G-code to
describe ASCVD risk management services that incorporate the ``ABCS''
of CVD risk reduction (aspirin, blood pressure management, cholesterol
management, and smoking cessation) for beneficiaries at medium or high
risk for ASCVD (>15 percent in the next 10 years) as previously
identified through an ASCVD risk assessment. We believe that ASCVD risk
management services include continuous care and coordination to reduce
or eliminate further elevation of ASCVD risk over time, and potentially
prevent the development of future cardiovascular disease diagnoses or
first-time heart attacks or strokes.
We are proposing new G-code, GCDRM, Atherosclerotic Cardiovascular
Disease (ASCVD) risk management services with the following required
elements: patient is without a current diagnosis of ASCVD, but is
determined to be at medium or high risk for CVD (15 percent
in the next 10 years) as previously determined by the ASCVD risk
assessment; ASCVD-Specific care plan established, implemented, revised,
or monitored that addresses risk factors and risk enhancers and must
incorporate shared decision-making between the practitioner and the
patient; clinical staff time directed by physician or other qualified
health care professional; per calendar month. Atherosclerotic
Cardiovascular Disease (ASCVD) risk management services refer to the
development, implementation, and monitoring of individualized care
plans for reducing cardiovascular risk, including shared decision-
making and the use of the ABCS of cardiovascular risk reduction, as
well as counseling and monitoring to improve diet and exercise. We
propose that the elements of the Atherosclerotic Cardiovascular Disease
(ASCVD) risk management service would include:
ASCVD Specific Risk Management, which may include:
++ Promoting receipt of preventive services (including tobacco
cessation counseling, diabetes screening, diabetes self-management
training)
++ Medication management (including aspirin or statins to maintain
or decrease risk of CVD)
++ Ongoing communication and care coordination via certified
electronic health record (EHR) technology
--Synchronous, non-face-to-face communication methods must be
offered
ASCVD-Specific, Individualized, Electronic Care Plan
++ Must address modifiable risk factors and risk enhancers specific
to CVD, as applicable, such as:
--blood pressure and cholesterol control
--smoking, alcohol, and other drug use status, history, and
cessation
--physical activity and nutrition
--obesity
++ Plan must be established, implemented, and monitored and must
incorporate shared decision-making between the practitioner and the
patient
Although there is no minimum service time requirement for ASCVD
risk management services in a month, each of the proposed elements must
be addressed to bill for the service, unless a particular element is
not medically indicated or necessary at that time for that specific
patient. For example, the element of smoking cessation would not be
addressed for a patient who does not use tobacco. Documentation of each
service element in the patient's medical record is required.
Physicians and non-physician practitioners (NPPs) who can furnish
E/M services could bill for ASCVD risk
[[Page 61730]]
management services. We anticipate that ASCVD risk management services
would ordinarily be provided by clinical staff incident to the
professional services of the billing practitioner in accordance with
our regulation at Sec. 410.26. We are proposing that ASCVD risk
management services would be considered a ``designated care management
service'' under Sec. 410.26(b)(5) and, as such, could be provided by
auxiliary personnel under the general supervision of the billing
practitioner.
We are proposing that patient consent must be obtained before
starting ASCVD risk management services. Like other care management
services, ASCVD risk management services would typically be provided by
clinical staff outside of face-to-face patient visits. Consent can be
written or verbal and must be documented in the medical record. Consent
should also include informing the patient about these services, as well
as potentially applicable Medicare cost-sharing.
We are proposing that ASCVD risk management services could be
billed no more often than once per calendar month, and that payment is
limited to one practitioner per beneficiary per month. Patients must be
determined to be at medium or high risk for CVD (>15 percent in the
next 10 years) as previously determined by the ASCVD risk assessment
and must not have a current diagnosis of cardiovascular disease or have
a history of heart attack or stroke.
We are seeking comments on each of these proposals.
(1) Proposed Valuation for ASCVD Risk Management Services (GCDRM)
We propose a direct crosswalk to 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), with a work RVU of 0.18 as we
believe this service reflects the resource costs associated when the
billing practitioner performs HCPCS code GCDRM. CPT code 99211 has a
physician intraservice time of 5 minutes, and the physician work is of
similar intensity to our proposed HCPCS code GCDRM. Therefore, we are
proposing a work time of 5 minutes for HCPCS code GCDRM based on this
same crosswalk to CPT 99211. We are also proposing to use this
crosswalk to establish the direct PE inputs for HCPCS code GCDRM, with
modifications to reflect non-face-to-face services. These modifications
include eliminating PE inputs used in face-to-face services such as
preparing and cleaning the room. We are seeking comments on these
proposals.
5. Strategies for Improving Global Surgery Payment Accuracy
a. Background
Currently, there are approximately 4,100 physicians' services that
are coded and valued under the PFS as global surgical packages (herein
``global packages''). Global packages are single codes that are valued
to include all services provided during a specified period of days (0-
day, 10-day, or 90-day global packages) by a physician (or another
practitioner in the same group practice (as defined at 42 CFR 411.352))
for a specific surgical procedure. The Medicare Physician Fee Schedule
(MPFS) look-up tool provides information on each procedure code,
including the global surgery indicator. This tool is available at
https://www.cms.gov/medicare/physician-fee-schedule/search/overview.
The global packages include:
The surgical procedure itself, including day-of pre-
service activities and day-of recovery care;
Post-operative evaluation and management (E/M) visits and
discharge services provided during specified post-operative periods
(10- or 90-day periods for most minor and major procedures,
respectively; 0-day global packages do not include post-operative
visits);
Pre-operative visits on the day of the procedure (for
services with 10- and 90-day periods) and pre-operative visits on the
day prior to the procedure (for major procedures with 90-day periods
only);
Services provided during the post-operative period (for
services with 10- and 90-day periods) related to the procedure (for
example, treatment of complications, pain management).
Any medical care that requires a return to the operating room
during the global period is paid separately and starts a new global
period. Like other services paid under the PFS, post-operative visits
that are part of the global packages can vary by level and site of
service. Global packages, including the pre-operative, day-of, and
post-operative visits associated with the surgical procedure, are
valued using our annual PFS rulemaking process.
As we discussed in the CY 2015 PFS final rule, we have identified
and articulated several concerns with the global packages related to
the accuracy of valuation and payment under the PFS. Foremost, we have
longstanding concerns regarding whether the packages are valued based
on estimates consistent with the number and kind of services actually
being furnished. Findings from multiple OIG reports suggest that
practitioners perform fewer post-operative visits than are expected and
accounted for in the valuation of the global packages. We provided a
detailed discussion of these concerns in the CY 2015 PFS final rule (79
FR 67582 through 67591). Similarly, we described concerns that global
packages as currently constructed may cause potential distortions in
valuation among PFS services, and that the structure of the current
packages assumes a single model of care delivery (a single practitioner
or other practitioners in the same group practice furnishing the
surgical procedure and all associated care) and does not appropriately
address scenarios where the surgical procedure and follow-up care are
provided by different practitioners in different group practices.
Taking these findings and concerns into account, we finalized a policy
to transition all 10-day and 90-day global packages to 0-day global
packages, which would allow any post-operative visits furnished after
the day of the procedure to be billed separately as standalone visits
by any practitioner who furnishes them. However, in 2015, through
amendments made by section 523 of the Medicare Access and CHIP
Reauthorization Act of 2015 (MACRA; Pub. L. 114-10, enacted April 16,
2015), we were prohibited under section 1848(c)(8)(A) of the Act from
implementing this finalized policy. Further, under section
1848(c)(8)(B), we were required to collect data beginning in 2017 on
the number and level of post-operative visits typically provided to
patients during 10- and 90-day global periods and to use this newly
collected data and other data beginning in 2019 to improve the accuracy
of global package valuation.
In response to these requirements, over the past 9 years, we have:
Initiated research contracts and implemented a data-
collection process to analyze data to understand the extent to which
post-operative visits are furnished to patients and improve the
accuracy of payment rates for the global surgical packages. This
research contract was funded by CMS (HHSM-500-2014-00036I) and carried
out within the Payment, Cost, and Coverage Program in RAND Health Care.
Released three reports (located at https://www.cms.gov/medicare/payment/fee-schedules/physician/global-surgery-data-collection) on the number of E/M visits furnished during post-operative
periods, the most recent finding that only 4 percent of expected post-
operative visits in 10-day global
[[Page 61731]]
packages and 38 percent of expected post-operative visits following 90-
day global packages were furnished to patients.
Fielded and released a report on a survey of selected
global packages, collecting information related to the level and
complexity of medical visits furnished during post-operative periods.
This research contract was funded by CMS (HHSM-500-2014-00036I) and
carried out within the Payment, Cost, and Coverage Program in RAND
Health Care.
Released two reports on potential approaches for revaluing
the global packages based on these findings.
Analyzed the prevalence of transfer of care modifiers (-54
for surgical care only; -55 for post-operative management only; and -56
pre-operative management only) applied to global packages.
More recently, in the CY 2023 PFS proposed and final rules, we
reviewed the prior work and conversations around the accuracy of global
package valuations and solicited comments from the public on (1)
suggested strategies for revaluing these services, (2) information on
how changes to healthcare delivery and payment may be impacting the
relevance or accuracy of global package payments, and (3) possible
impact of changes to global packages on health care access for
beneficiaries (see 87 FR 69432 through 69437). In response to the
comment solicitation in the CY 2023 PFS proposed rule, some commenters
generally disagreed with our findings that the post-operative visits in
the global packages are not performed as frequently as assumed in our
valuation of global surgical packages. However, opposition from
commenters was based on anecdotal assertions rather than alternative
data. Many of these commenters' specific points restated earlier
comments submitted in response to our request for feedback in the CY
2020 PFS proposed rule on claims-based reporting of post-operative
visits, survey findings on the level of visits, and potential
revaluation approaches. Some commenters supported eliminating 10-day
global package periods and requested that the AMA RUC review these
services. However, these commenters also acknowledged that the AMA RUC
review process could take years. In addition to the comments we
received in response to the CY 2023 PFS proposed rule, we have received
feedback over several years from many interested parties regarding the
findings from claims-based reporting of post-operative visits and
considered revaluation methodologies presented in our prior reports.
Overall, we have continued exploring ways to improve the accuracy
of valuation and payment for global packages to ensure appropriate
payments to the practitioners providing pre-operative, surgery, and
post-operative care to Medicare beneficiaries while considering
feedback from interested parties. In addition, commenters have not
proposed specific alternative strategies to revalue global surgical
packages.
Separately, we continue to review approaches to better describe
physicians' services in the context of the evolving care delivery
landscape and to allow practitioners to furnish patient-centered care.
Our review work includes considering care delivery models discussed
with interested parties (and developed though our CMS Innovation Center
work), reviewing our policies and billing requirements, identifying
care elements that could serve as the building blocks for describing
newer, impactful services, and seeking opportunities to reduce
administrative burdens for practitioners while ensuring accurate
payment. Through this lens, we have also recently reviewed our billing
requirements and payment policies for the global packages, concurrent
with continued analysis of the Medicare claims data.
While ongoing, our review highlights opportunities for us to
clarify or revise longstanding policy and billing instructions for
global packages, using data and experience gathered over the last
several years, consistent with our overall objectives to pay more
accurately for services and to right-size the valuation of PFS services
based on how practitioners currently furnish these services. In this
proposed rule, we discuss proposals (1) to revise our transfer of care
policy for global packages to address instances where one practitioner
furnishes the surgical procedure and another practitioner furnishes
related post-operative E/M visits during the global period, and (2) to
develop a new add-on code that would account for resources involved in
post-operative care provided by a practitioner who did not furnish the
surgical procedure. We believe that addressing the use of transfer of
care modifiers, and the resources involved when practitioners who do
not furnish the surgical procedure provide post-operative care, are
essential steps in aligning payment with the way in which surgical
procedures are currently furnished as evidenced in our data, and would
make meaningful progress toward more accurate payment for these
services in particular and improve relative valuation for PFS services
overall.
b. Clarifying the Scope of Global Surgical Packages
We have valued global packages to include the surgical procedure
and services furnished during the specified global period related to
the surgical procedure when furnished by the practitioner who performs
the surgery (hereafter in this section, the proceduralist) or by
another practitioner in the same group practice as the proceduralist.
Under current Medicare payment policy, certain services furnished
during the global period by the proceduralist or by another
practitioner in the same group practice may be separately billed with
an appropriate modifier:
Initial decision for surgery: E/M service billed with
modifier -57 (Decision for Surgery).
E/M services unrelated to the procedure: billed with
modifier -24 (Unrelated E/M Service During a Global Period).
Other services unrelated to the procedure (including
underlying condition treatment, diagnostic tests, distinct procedures)
not including care for complications/returns to the operating room: no
modifier required.
Failure of a less extensive procedure requiring a more
extensive procedure: no modifier required.
Organ transplant immunosuppressive therapy: no modifier
required.
Critical care services unrelated to surgery: billed with
modifier -FT if in the post-operative period.
In general, except where a formal transfer of care modifier
applies, a practitioner other than the proceduralist or a practitioner
in the same group practice as the proceduralist can bill separately for
an E/M visit for services they furnish during the global period for a
global package, including post-operative E/M visits related to the
procedure. We established formal transfer of care modifiers to apply in
cases where the work, time, and resources involved in furnishing
services included in the global packages are split between the
proceduralist (or another practitioner in the same group practice) and
other practitioners providing related post-operative visits during the
global period. Under our current transfer of care policy, transfer of
care modifiers must be reported when a formal transfer of care
arrangement is documented by both the proceduralist and another
practitioner providing the related post-operative visits. Based on our
analysis of Medicare fee-for-service
[[Page 61732]]
claims data, these formal transfer of care modifiers are rarely used
and, when they are, it is often with respect to certain ophthalmologic
procedures (for example, cataract surgery).
Based on our analysis of claims data, we believe that it may be
helpful to review our current policy regarding the applicability of
transfer of care modifiers for the medical and billing communities.
Under our current policy, the scope of the global package extends to
services furnished by the entire group practice of the proceduralist,
including services furnished by practitioners in the group practice who
are a different specialty from the proceduralist. In other words, the
PFS payment for post-operative visits and other services furnished
during the global period that are related to the surgical procedure and
provided by the proceduralist or a practitioner in the same group
practice as the proceduralist is bundled into the global package, and
those services are not separately billable. If the proceduralist or a
practitioner in the same group practice as the proceduralist wants to
bill during the global period for a service furnished to the surgical
patient, but unrelated to the global package, the correct modifier must
be used to indicate that the service is not related to the global
package. Without a modifier to indicate otherwise, during the global
period for a global package, all E/M services furnished to the patient
by the proceduralist or another practitioner in the same group practice
as the proceduralist are presumed to be related to, and included in the
payment for, the global package. Modifiers for separate payment (such
as modifier -24) are required when services unrelated to the global
package are billed by the proceduralist or a practitioner in the same
group practice as the proceduralist during the global period.
c. Strategies To Address Global Package Valuation
We recognize that we are precluded under section 1848(c)(8)(A) of
the Act from revisiting the policy we established in the CY 2015 PFS
final rule to revalue all 10-day and 90-day global packages to 0-day
global packages (79 FR 67582-67591). Further, we note that
transitioning all global packages to 0-day global periods could take
several years and require substantial CMS resources (see CY 2014 PFS
final rule (77 FR 44737 through 44738) for previous discussion). We
have also considered revaluing 10-day and 90-day global packages to
reflect the observed number of post-operative visits furnished to
patients based on data we have collected over nearly a decade and note
that this approach would be quicker to implement, assuming there would
be straightforward ways to revalue the services with the data. However,
interested parties have continued to express uncertainty about the
validity of claims-based counts of post-operative visits. This
uncertainty stems primarily from CMS not having complete information
surrounding the use of the transfer of care modifiers since they are
not currently routinely used. The same interested parties also object
conceptually to revaluing the 10-day and 90-day global packages using
the ``building block'' framework, where each component of a service,
including bundled post-operative visits, contributes to total valuation
to align valuation with the number of post-operative visits typically
provided to patients. Some interested parties have expressed larger
concerns about the redistributive impacts across the PFS among
specialties if we were to implement and revalue all global packages.
We acknowledge the practical challenges involved in revaluing 10-
day and 90-day global packages, whether they remain as 10-day and 90-
day periods with fewer post-operative visits or are transitioned to 0-
day global packages, and continue to carefully consider how to best
improve global package valuation given access to administrative claims
data and other inputs that help us understand the scope of services
provided to patients within global packages. Ultimately, we want to
ensure payments to practitioners and the relative values assigned to
global surgical packages are accurate and, to the extent possible,
driven by real-world objective and updatable information regarding the
relative resources involved in furnishing the services.
For CY 2025, we are focused on different aspects of our policy
objectives for global packages and propose the following policies,
which are not mutually exclusive, to obtain information and allow for
more accurate payment to reflect time and resources spent on post-
operative care associated with the current global packages. We will
continue to assess and monitor for potential future opportunities to
improve our payment approach for the global packages more broadly.
Additionally, in developing our proposed policies to pay more
accurately for the global packages, we also considered whether, when,
or how our policies may be affected when services are provided by the
proceduralist, versus another practitioner who did not perform the
procedure but is providing follow up care. We also recognize that there
may be multiple practitioners in the same or different specialties in
the same group practice and considered how our policies should apply to
practitioners in a range of specialties within the same group practice.
We are seeking comment on these considerations in the context of our
proposed policies and welcome feedback that may further inform our
payment policy for global packages. Additionally, as we continue to
better understand what services are being furnished in the global
period, by whom, and how the global surgical packages are valued and
billed, we are seeking comment on how remote monitoring and other types
of new technologies represent new resource costs and/or produce
efficiencies and effectiveness of post-operative care. This information
could be useful both for purposes of valuation for surgical and post-
operative care, as well as for policies regarding when specific PFS
codes should be reported during global periods for global packages.
d. Expand Applicability of Transfer of Care Modifiers
We created transfer of care payment modifiers at the inception of
the PFS. Under our current policy, these modifiers are required to be
appended to the relevant global package code when billing for services
that are within the scope of the global package (within the global
period and related to the surgical procedure) only when the
proceduralist and one or more other practitioners who are not in the
same group practice as the proceduralist formally document their
agreement to provide distinct portions of the global package.
The following transfer of care modifiers describe the different
portions of the global surgical package that could be provided by
different practitioners:
Modifier -54 Surgical Care Only: this modifier is appended
to the relevant global package code to indicate that the proceduralist
performed only the surgical procedure portion of the global package.
Modifier -55 Post-operative Management Only: this modifier
is appended to the relevant global package code to indicate that the
practitioner performed only the post-operative management portion of
the global package.
Modifier -56 Pre-operative Management Only: this modifier
is appended to the relevant global package code to indicate that the
practitioner performed only the pre-operative portion of the global
package.
[[Page 61733]]
For each of these modifiers, the payment for the global package is
adjusted based on the applicable percentage noted in the PFS Relative
Value files (https://www.cms.gov/medicare/payment/fee-schedules/physician/pfs-relative-value-files).
As previously noted, we currently require the transfer of care
modifiers (-56 pre-operative care, -54 for procedures, and -55 for
post-operative care) to be appended in cases where there is a formal
documented transfer of care agreement, that is, ``in the form of a
letter or an annotation in the discharge summary, hospital record, or
Ambulatory Surgical Center (ASC) record'' (CMS Manual System, Pub 100-
04 Medicare Claims Processing, Transmittal 11287). In our recent
analyses of 2022 Medicare claims data, we identified that these
modifiers were rarely used other than for certain ophthalmology global
packages. We found over 99 percent of claim lines for 90-day surgical
procedures billed with modifier -54 were ophthalmology services
(primarily cataract-related procedures). We also identified a
difference in the number of claim lines annually for a given 90-day
global package with modifier -54 and with modifier -55. In other words,
there are sometimes more claim lines billed with modifier -54 than
there are corresponding lines with modifier -55 and vice versa during a
year. We note that modifier -56 (pre-operative management only) is only
very rarely used in practice. These recent observations suggest (1) the
overwhelming concentration of reported transfer of care modifiers is in
ophthalmology procedures, and (2) a potential mismatch in billing for
formal transfer of care cases between proceduralists and other
practitioners providing post-operative care.
While we recognize the benefits to continuity of care when the
proceduralist also provides pre-operative and follow-up care for the
procedure, we also recognize that it is not always feasible, or even
perhaps typical practice for the same practitioner to furnish all
portions of the global package; for example, in instances when the
practitioner furnishing the procedure does not schedule a post-
operative visit(s) on the day of the procedure or plans for the patient
to follow up with their primary care provider, or when the practitioner
performing the surgery arranges alternative follow-up care because it
would be difficult for the beneficiary to travel to return for follow-
up care. Because our current policies require use of the transfer of
care modifiers only where there is a formal documented agreement
between practitioners to provide specific portions of the global
package, we believe there are many practical and potentially common
circumstances under which the transfer of care modifiers would not be
required or used.
Beginning for services furnished in 2025, we are proposing to
broaden the applicability of the transfer of care modifiers for the 90-
day global packages. We are proposing to require the use of the
appropriate transfer of care modifier (modifier -54, -55, or -56) for
all 90-day global surgical packages in any case when a practitioner
plans to furnish only a portion of a global package (including but not
limited to when there is a formal, documented transfer of care as under
current policy, or an informal, non-documented but expected, transfer
of care). Practitioners billing for a global package procedure code
with modifier -54 and other practitioners in the same group practice as
that practitioner would still be able to bill during the global period
for any separately identifiable E/M services they furnish to the
patient that are unrelated to the global package procedure. To do so,
the practitioner would append modifier -24 to the claim line for the E/
M service.
This proposed policy, which would be a first step toward improved
valuation and payment while retaining the fundamental structure of the
global packages, would provide us with more accurate information on the
resources involved in furnishing components of global surgical
packages. This proposal would prevent duplicative Medicare payment for
post-operative care because the global surgical package payment would
be adjusted based on the appended modifier, and payment for post-
operative care would not be made both as part of a global surgical
package and through separately billed E/M visits. We also anticipate
that the proposed policy would provide us with insight into changes in
standards of practice and post-operative patient care for services that
are not billed with transfer of care modifiers pursuant to our current
policy (that is, services other than certain ophthalmology procedures).
We acknowledge the potential challenge associated with anticipating
whether other practitioners will furnish portions of the global package
and, accordingly, appending the appropriate modifier when billing
global package services.
We are interested in understanding and are seeking comment on the
circumstances under which practitioners in separate group practices
furnish different portions of the care included in global packages, and
what that means for reporting the transfer of care modifiers. While we
are making proposals related to the 90-day global periods beginning for
services furnished in 2025, we are also seeking comment on whether we
should consider proposing these changes for the 10-day global packages
in future rulemaking.
e. Payment for Global Packages
Under our current policy for global packages where the transfer of
care modifiers are used (required only where there is a formal transfer
of care arrangement), the total combined PFS payment made for the
global package during the global period does not exceed the total
global surgical package payment established for the procedure when
billed without any transfer of care modifier. In general, we continue
to believe this is the appropriate result when more than one
practitioner furnishes portions of a global package. Under our
proposal, we would require that practitioners performing the surgical
procedure but not intending to furnish the post-operative portions of a
90-day global service would appropriately append the -54 modifier that
we have previously discussed, which would adjust the portion of payment
received to accurately reflect the service furnished.
More specifically, as noted in the discussion above, the transfer
of care modifiers correspond to three distinct portions of the global
package (pre-operative services, the surgical procedure itself, and
post-operative care). We have assigned a proportion of the global
package payment to each portion of the service based on longstanding
assumptions. Under our current policy, the payment for the entire
global package is paid to the billing practitioner unless a transfer of
care modifier is included on the claim. Payment is only adjusted if a
transfer of care modifier is included on the claim. We are requesting
comments, as we further develop our payment policies for global
packages, on how best to determine the appropriate payment proportions
for the three portions of the global package, which impact payment to
the different practitioners who furnish the different portions of the
service.
We are continuing to consider approaches to establishing the
payment allocations for portions of the global package when the
transfer of care modifiers are used, and anticipate revising the
allocations through future rulemaking. We are seeking comment on
[[Page 61734]]
potential approaches to revise these payment allocations and how they
could be established to better reflect current medical practice and
conventions for post-operative follow-up care. We seek to identify a
procedure-specific, data-driven method for assigning shares to portions
of the global package payment to more appropriately reflect the
resources involved in each portion. We would appreciate and carefully
consider recommendations from interested parties, including the AMA
RUC, on what those allocation percentages should be, based on how the
global package codes are valued and any other relevant information.
We have contracted with RAND to support data collection and
analysis in the past and, as identified in RAND's prior reports and
described in detail, we surmise that the policy to apportion and pay
for the three portions of the global package based on the presence of
transfer of care modifiers does not always work smoothly. In
considering RAND's reports, one reason for this is that fewer post-
operative visits are provided to patients compared to the number of
visits reflected in the valuation of global packages. The global
packages reflect a certain number of post operative visits (noted in
the Physician Time File) that typically occur during the post-operative
global period. However, there is no easy way within a global package to
separate the RVUs for the procedure itself from the RVUs for post-
operative visits that are not typically provided to patients. If our
allocation of the global package payment based on the presence of
transfer of care modifiers were to undervalue the surgical procedure
portion or the post-operative care portion of the global package, we
are concerned that we could unintentionally introduce incentives that
influence current medical practice for transfers of care. This gets at
RAND's prior recommendation that we revalue global packages to reflect
the actual number of post-operative visits provided to patients. After
revaluation, separating the procedure and post-operative payments would
reflect observed data and mitigate any possible inappropriate
incentives in place for practitioners to initiate transfers of care and
support use of transfer of care modifiers as medically appropriate.
This approach has the advantage of anchoring the valuation of separate
-54 and -55 components using real-world information on post-operative
visits reported to CMS rather than on historical assumptions or current
survey data reflecting estimates of the typical number and level of
visits.
In our internal review of the percentages assigned for the pre-
operative, surgical care, and post-operative portions of the global
package, we found that there are a small number of codes that do not
have any assigned percentages in our files even though these codes are
identified as global packages. HCPCS codes 77750 (Infusion or
instillation of radioelement solution (includes 3-month follow-up
care)), HCPCS code 77761 (Intracavitary radiation source applic
simple), HCPCS code 77762 (Intracavitary radiation source applic
intermed), and HCPCS code 77763 (Intracavitary radiation source applic
complex) do not have assigned percentages in our RVU files. It is our
understanding, however, that the MACs have local edits in place to
ensure appropriate payment for these services when billed with the
transfer of care modifiers. We are seeking comment on whether we should
consider, first, whether these codes are appropriately categorized as
90-day global package codes. If these are appropriately considered to
be 90-day global package codes, we are seeking comment on what the
assigned percentages should be for the pre-operative, surgical care,
and post-operative portions of the service.
f. Post-Operative Care Services Add-On Code
We recognize the importance of continuity in surgical and post-
operative care. However, we recognize that there are instances where
post-operative care is not furnished by the proceduralist or another
practitioner in the same group practice, or even by a practitioner who
is in the same specialty as the proceduralist, despite there being no
formal transfer of care. We also recognize that there is an extra level
of complexity involved when a practitioner sees a patient post-
operatively after a surgical procedure performed by another
practitioner in those circumstances. The practitioner providing the
post-operative care may not be involved in creating the surgical plan,
and may not have access to the operative notes to know how the surgery
went or be abreast of any particular considerations related to the
procedure that may factor in medical care decisions for the post-
operative care. As such, we recognize that there are comparatively more
resource costs incurred when a practitioner who did not furnish the
surgical procedure in a global package provides the follow-up care. We
are proposing to address these scenarios, which can occur in a few
different ways, by establishing a new add-on code that would account
for resources involved in post-operative care for a global package
provided by a practitioner who did not furnish the surgical procedure
and does not have the benefit of a formal transfer of care. However, we
note that when a patient is seen by practitioners in the same group
practice or specialty as the surgeon, the same resources are not
incurred during follow-up and therefore, the add-on code should not be
billed by another practitioner in the same group practice as the
practitioner who performed the surgical procedure, or in the same
specialty as the practitioner who performed the surgical procedure. In
the case of a practitioner providing follow up care who is of a
different specialty and not within the same group practice as the
proceduralist, researching the procedure to determine expected post-
operative course and potential complications may be needed, which would
warrant using the add-on code. We also acknowledge that sometimes the
proceduralist does not schedule the patient to follow up with them
post-operatively and directs the patient to follow up with other
practitioners as needed, such as with the patient's primary care
provider. The patient may independently choose to follow up with their
primary care provider or another practitioner based on other
considerations such as convenience of the practice location or ease of
scheduling. We understand and acknowledge that the patient can choose
to see another practitioner without the knowledge of the practitioner
who performed the procedure.
To more appropriately reflect the time and resources involved in
these kinds of visits, we are proposing to make payment using a new
add-on code to be billed with an office/outpatient E/M visit for post-
operative follow-up care during the global period of a global package
to capture additional resources associated with practitioners who were
not involved in furnishing the surgical procedure. This follow-up care
may include, but is not limited to, obtaining and reviewing the
surgical notes and surgical history, monitoring for signs and symptoms
of infection, taking into account any considerations from the surgical
procedure that may affect the medical care, and monitoring for any
potential post-operative complications that may arise. It is often
difficult in these circumstances for the practitioner who did not
perform the surgical procedure to know how the wound looked after the
procedure, and so it is more challenging to recognize possible changes
that may have occurred since
[[Page 61735]]
the time of the procedure (when this is something the operating surgeon
would have been able to know). This new code would be billed by the
practitioner who furnishes the post-operative office/outpatient E/M
visits when that practitioner is not the proceduralist and is not in
the same specialty or group practice as the proceduralist.
Documentation in the medical record must justify use of the add-on code
and that the E/M visit was, as clinically understood by the reporting
practitioner, related to a post-operative visit furnished during the
90-day post operative period. As noted earlier, we are proposing to
expand the required use of the transfer of care modifiers as a first
step toward improving payment for the global packages to promote
improved valuation and payment for these services. Instituting an add-
on code to capture the time and intensity of post-operative work absent
a formal transfer of care, would be an essential step in recognizing
how the services are currently furnished and make meaningful progress
toward `right-sizing' the structure of the global packages.
Given the history of the global packages since data collection
began, as specified in section 1848(c)(8) of the Act, and in
consideration of our policies for post-operative care and our proposal
requiring the use of the transfer of care modifiers in a broader set of
circumstances, we believe that the timing is appropriate to establish
an add-on code and payment for post-operative care provided in the
office/outpatient setting by a practitioner other than the
proceduralist (or another practitioner in the same specialty) to
account for the additional time, intensity, and resources that are
involved in post-operative care. We are proposing a new HCPCS code,
GPOC1, to capture the additional time and resources spent in providing
follow up post-operative care by a practitioner who did not perform the
surgical procedure and who has not been involved in a formal transfer
of care agreement.
We propose the following code and descriptor for the proposed add-
on code: GPOC1 (Post-operative follow-up visit complexity inherent to
evaluation and management services addressing surgical procedure(s),
provided by a physician or qualified health care professional who is
not the practitioner who performed the procedure (or in the same group
practice), and is of a different specialty than the practitioner who
performed the procedure, within the 090-day global period of the
procedure(s), once per 090-day global period, when there has not been a
formal transfer of care and requires the following required elements,
when possible and applicable:
Reading available surgical note to understand the relative
success of the procedure, the anatomy that was affected, and potential
complications that could have arisen due to the unique circumstances of
the patient's operation.
Research the procedure to determine expected post-
operative course and potential complications (in the case of doing a
post-op for a procedure outside the specialty).
Evaluate and physically examine the patient to determine
whether the post-operative course is progressing appropriately.
Communicate with the practitioner who performed the
procedure if any questions or concerns arise. (List separately in
addition to office/outpatient evaluation and management visit, new or
established)).
We are proposing that HCPCS code GPOC1 would be reported by a
physician or other practitioner who did not perform the surgical
procedure for a global package and provides related post-operative
visits during the global period despite the absence of a formal
transfer of care. We are proposing that the add-on code (HCPCS code
GPOC1) would only be reported with an office or other outpatient E/M
visit for the evaluation and management of a new or established
patient. We would expect the documentation in the medical record to
indicate the relevant surgical procedure, to the extent the billing
practitioner can readily identify it, in order to aid in our
understanding of the post-operative care being furnished and when there
is no transfer of care modifier appended on the claim.
We are proposing that this code could be billed only once during
the 90-day global period for the global package because we believe the
practitioner would only have additional resource costs upon the first
visit following the procedure. We are proposing to assign a ZZZ global
period payment indicator for HCPCS code GPOC1, as this allows the add-
on code to be billed during the post-operative time frame that applies
to payment for each surgical procedure and, under our proposed policy,
this code would be reportable with an E/M visit. The ZZZ global period
payment indicator would identify this code as a service that is related
to another service paid under the PFS and is always included in the
global period of the other service.
g. Proposed Valuation for GPOC1 Add-On Code
We note that the proposed valuation of HCPCS code GPOC1 is meant to
capture the additional resource costs, including for visit complexity
inherent to office/outpatient care associated with a post-operative
visit that is not accounted for in the appropriate office/outpatient E/
M base code billed by the physician or practitioner. Therefore, we
believe that CPT code 90785 (Interactive complexity (List separately in
addition to the code for primary procedure)) serves as an appropriate
reference for the purposes of valuing HCPCS code GPOC1. CPT code 90785
was created to capture additional work that occurs during diagnostic
psychiatric evaluation, psychotherapy, psychotherapy performed with an
E/M service and group psychotherapy sessions, and the service refers to
specific communication factors that complicate the delivery of a
psychiatric/psychotherapy procedure. However, we believe there may be
relatively less work involved for GPOC1 when compared to the work of
CPT code 90785, considering the amount of time needed to gather the
operative history and conduct the elements discussed above. Therefore,
we are proposing a work RVU of 0.16, which represents approximately
half of the assigned work for minutes of CPT code 90785. Additionally,
we are proposing a work time of 5.5 minutes (or half of the 11 minutes
established for CPT code 90785), personally performed by the billing
practitioner including the elements discussed above during the post-
operative E/M visit furnished during the global period, that is, no
later than 90-days following a 90-day global code, respectively. CPT
code 90785 has no direct PE inputs, and we are proposing the same for
HCPCS code GPOC1.
To help inform whether our proposed valuation reflects the typical
service, we are seeking comment the typical time and intensity
physicians and practitioners spend over and above a separately billed
E/M visit when providing post-operative care to a patient when they did
not perform the surgical procedure, gathering the surgical history as
well as the pre-operative, intra-operative, and post-operative, and on
the proposed service elements and the relative intensity compared to
similar service elements of other CPT codes. For the individual
practitioner, not having an intimate knowledge of the procedure itself
and not having a before/after comparison to look at for the wound can
all complicate
[[Page 61736]]
their E/M visit. The proposed work RVUs are intended to account for the
additional relative resource costs in time and intensity in addition to
those involved in the E/M visit.
Finally, we recognize that historically, the CPT Editorial Panel
has frequently created CPT codes describing services for which we
originally established G-codes and adopted them through the CPT
Editorial Panel process. We note that we would consider using any newly
available CPT coding to describe services similar to those described
here in future rulemaking.
For discussion of our expected utilization assumptions for this
service, see the discussion in the Regulatory Impact Analysis section
of this proposed rule.
H. Supervision of Outpatient Therapy Services in Private Practices,
Certification of Therapy Plans of Care With a Physician or NPP Order,
and KX Modifier Thresholds
1. Supervision of Outpatient Therapy Services in Private Practices
In the CY 2024 PFS final rule, we finalized our proposal to allow
remote therapeutic monitoring (RTM) services to be furnished by
occupational therapy assistants (OTAs) and physical therapy assistants
(PTAs) under the general supervision of occupational therapists (OTs)
and physical therapists (PTs) in private practice, in an effort to
align with the general supervision policy for these services for
physicians and other practitioners described in the CY 2023 final rule
(88 FR 78990). We also noted that we would consider for possible future
rulemaking the commenters' responses to our request for information
(RFI) on changing the supervision of therapy assistants in the private
practice setting to general supervision for all therapy services (88 FR
78990 through 78992).
In the CY 2024 PFS proposed rule, we reviewed the statutory
provisions at sections 1861(p) and 1861(g) (by cross-reference to
section 1861(p)) of the Act that describe outpatient physical therapy
and occupational therapy services furnished to individuals by physical
therapists (PTs) and occupational therapists (OTs) meeting licensing
and other standards prescribed by the Secretary if the services meet
the necessary conditions for health and safety. These statutory
provisions refer separately to outpatient therapy services furnished by
a provider of services (such as a rehabilitation agency) and those
services furnished in the therapist's office or the individual's home,
thus distinguishing therapists who work for an institutional provider
of therapy services from therapists who furnish and bill independently
for these outpatient therapy services (88 FR 52358 through 52359). In
regulations, we have addressed these therapists as physical or
occupational therapists in private practice (PTPPs and OTPPs) (63 FR
58868 through 58870). The regulations specific to services furnished by
occupational or physical therapists in private practice are found at
Sec. Sec. 410.59(c) and 410.60(c), respectively.
We also summarized a history of related regulatory provisions in
the CY 2024 PFS proposed rule. In the CY 2005 PFS final rule with
comment period (69 FR 66236, 66351 through 66354), we explained that
the personnel requirements that are applicable for Home Health Agencies
(HHAs) at 42 CFR part 484 for therapists, therapy assistants and
speech-language pathologists (SLPs) apply to all outpatient physical
therapy, occupational therapy, and speech-language pathology services.
In the CY 2005 PFS final rule, we also added a basic rule at Sec. Sec.
410.59(a) and 410.60(a), respectively, by cross-referencing 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.
Later, 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, and SLPs.
In the CY 2024 PFS proposed rule, through our RFI on general
supervision of OTAs and PTAs by OTPPs and PTPPs, respectively, we
solicited public comment, along with supporting data, for our
consideration for possible future rulemaking about the following: (a)
the questions and concerns we highlighted related to access, patient
safety, and utilization; (b) revising Sec. Sec. 410.59(a)(3)(ii) and
(c)(2) and 410.60(a)(3)(ii) and (c)(2) to permit general supervision of
OTAs and PTAs by the OTPP and PTPP, respectively, when furnishing
therapy services; and (c) any appropriate exceptions to allowing
general supervision in the furnishing of therapy services (88 FR 52358
through 52359).
In the CY 2024 PFS final rule, we reviewed the comments we received
in response to the proposed rule (please refer to (88 FR 78990 through
78992)). We noted that we would consider these comments for possible
future rulemaking--see our review of comments on the RFI in the CY 2024
PFS final rule (88 FR 78992).
Over the past several years and again more recently, we have heard
from interested parties that the direct supervision requirements in the
private practice setting are problematic for OTPPs and PTPPs who must
remain on-site and immediately available when Medicare patients are
treated in order to bill for therapy services furnished by their
supervised OTAs and PTAs. As a remedy to this situation, interested
parties have requested that we revise our requirement for PTPPs and
OTPPs to provide direct supervision of OTAs and PTAs to align with the
general supervision policies for OTs and PTs that work in Medicare
institutional settings that provide therapy services (for example,
rehabilitation agencies, outpatient hospitals, SNFs and comprehensive
outpatient rehabilitation facilities (CORFs), etc.), to allow for the
general supervision of their therapy assistants. These interested
parties tell us that their respective State laws and policies allow
general supervision of therapy assistants (most often requiring the OT
or PT to be in touch with their therapy assistants via
telecommunication) in at least 44 States for PTAs,\136\ and all but one
State for OTAs.
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\136\ Federation of State Boards of Physical Therapy
Jurisdiction Licensure Reference Guide https://www.fsbpt.net/lrg/Home/SupervisionRequirementLevelsBySetting.
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Some interested parties have reported that allowing for general
supervision of OTAs and PTAs by OTPPs and PTPPs, respectively, would
allow for patients to have increased access to outpatient therapy
services, even with ongoing healthcare workforce shortages. The
shortages of OTs \137\ and OTAs,\138\ PTs,\139\ and PTAs,\140\ are
noted by the United States Bureau of Labor Statistics, which shows
thousands of open positions in all of these fields. Interested parties
noted that over 22,000 PTs left the workforce in 2021.\141\
Additionally,
[[Page 61737]]
these interested parties noted that workforce shortages have greater
impact on private practices in rural and underserved areas where hourly
wages are lower, and the OTPPs and PTPPs in these areas tend to have
small practices. The interested parties stated that Medicare's direct
supervision policy, which requires the PTPP and the PTA to both be
present when a Medicare patient is treated, does not allow small
practices with one PT and one or two PTAs, for example, to work
different or overlapping schedules in order to accommodate all
patients' availability by allowing the OTA/PTA to work before or after
the OTPP/PTPP normal hours. The interested parties also stated that the
direct supervision requirement can unfairly delay care for Medicare
patients when, for example, a PTPP or OTPP is out sick, the practice
does not have alternative coverage, and appointments for Medicare
patients must be canceled.
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\137\ Bureau of Labor Statistics, U.S. Department of Labor,
Occupational Outlook Handbook, Occupational Therapists, at https://www.bls.gov/ooh/healthcare/occupational-therapists.htm (visited
April 17, 2024).
\138\ Bureau of Labor Statistics, U.S. Department of Labor,
Occupational Outlook Handbook, Occupational Therapy Assistants and
Aides, at https://www.bls.gov/ooh/healthcare/occupational-therapy-assistants-and-aides.htm (visited April 17, 2024).
\139\ Bureau of Labor Statistics, U.S. Department of Labor,
Occupational Outlook Handbook, Physical Therapists, at https://www.bls.gov/ooh/healthcare/physical-therapists.htm (visited April
17, 2024).
\140\ Bureau of Labor Statistics, U.S. Department of Labor,
Occupational Outlook Handbook, Physical Therapist Assistants and
Aides, at https://www.bls.gov/ooh/healthcare/physical-therapist-assistants-and-aides.htm (visited April 17, 2024).
\141\ See the report by Definitive Healthcare dated October 2022
at https://www.definitivehc.com/sites/default/files/resources/pdfs/Addressing-the-healthcare-staffing-shortage.pdf.
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In light of this input, we believe that the direct supervision
requirement for OTPPs and PTPPs of OTAs and PTAs, respectively, may
have had an unintended consequence of limiting access to needed therapy
services. As noted by interested parties, both the OTPP/PTPP and their
respective OTA/PTA must be present in the office in order to bill and
receive Medicare payment for therapy services furnished by OTAs and
PTAs. This means, for example, that an OTPP/PTPP cannot bill and
receive payment for therapy services furnished to a Medicare patient in
their home when furnished by an OTA/PTA, without the presence of the
OTPP/PTPP. The direct supervision requirement for OTAs and PTAs in the
private practice setting is more stringent than the supervision
requirements for OTAs and PTAs in institutional settings. For example,
as we noted in the CY 2024 PFS proposed rule, 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 also cited Table 4 in our 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,'' \142\ in the CY 2024 PFS proposed rule to
demonstrate that the minimum level of supervision by PTs and OTs for
services performed by PTAs and OTAs working in institutional settings
is a general level of supervision, in accordance with various
regulations (88 FR 52359). Therefore, we believe that a change from
direct to general supervision would allow OTPPs and PTPPs the
flexibility to better accommodate patients' availability and act to
ensure access to necessary therapy services. A change from direct to
general supervision would also allow OTPPs and PTPPs to bill and
receive Medicare payment for therapy services furnished by their OTAs
and PTAs when they are not in the office or patient's home at the same
time.
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\142\ See Table 4 of 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 at https://www.cms.gov/Medicare/Billing/TherapyServices/Downloads/61004ptartc.pdf.
---------------------------------------------------------------------------
We also believe that it is important to better align our
supervision policies for OTPPs and PTPPs with the majority of state-
established supervision levels for therapy assistants providing
occupational therapy and physical therapy services. We note that the
majority of states allow OTs and PTs to provide general supervision of
their respective OTAs and PTAs when furnishing occupational therapy and
physical therapy services. We believe that States are well aware of the
health and safety needs for their residents who receive therapy
services from OTs and their supervised OTAs, and PTs and their
supervised PTAs. Given these beliefs and the input from interested
parties, we are proposing to revise our regulations at Sec. Sec.
410.59(a)(3)(ii) and (c)(2) and 410.60(a)(3)(ii) and (c)(2) to allow
for general supervision of OTAs and PTAs by OTPPs and PTPPs, when the
OTAs and PTAs are furnishing outpatient occupational and physical
therapy services, respectively. We expect that this proposal would both
increase access to therapy services and more closely align Medicare
policy with the majority of State practice acts for occupational
therapy and physical therapy. This will parallel the 44 States that
allow general supervision of PTAs and the 49 States that allow general
supervision of OTAs (most often described as requiring the PT or OT to
be in touch via telecommunication). For the States with more
restrictive supervision levels, such as direct supervision, those
therapy services are always furnished to the extent that is permitted
under State law. We note that while we are proposing to allow for
general supervision by OTPPs and PTPPs of their OTAs/PTAs, an OTPP or
PTPP would still be required to provide direct supervision to
unenrolled OTs and PTs, respectively, in accordance with Sec. Sec.
410.59(c)(2) and 410.60(c)(2).
We are soliciting comment on our proposals.
2. Certification of Therapy Plans of Care With a Physician or NPP Order
Sections 1861(p), (g), and (ll)(2) of the Act require that an
individual outpatient is under the care of a physician and for whom a
plan for the physical therapy, occupational therapy, or speech-language
pathology services that are to be furnished has been established by a
physician or by a qualified PT, OT, or SLP and is periodically reviewed
by a physician. Sections 1835(a)(2)(C) and 1835(a)(2)(D) of the Act
require that payment for Medicare therapy services may be made for
outpatient physical therapy, occupational therapy, and speech-language
pathology services only if a physician certifies (and recertifies,
where such services are furnished over a period of time) that: (a) the
services are or were required because the patient needs or needed
therapy services; (b) a plan for furnishing such services was
established by a physician or qualified therapist providing such
services, and is periodically reviewed by the physician; and (c) the
services are or were furnished while the individual was under the care
of a physician.
In accordance with the statute and Sec. 424.24(b), Medicare Part B
pays for outpatient physical therapy and speech-language pathology
services furnished by providers only if a physician certifies the
content specified in Sec. 424.24(c)(1) or (4). We recognize that it
may not be clear that Sec. 424.24(c) applies to the occupational
therapy services furnished by providers, since occupational therapy
services are currently only explicitly mentioned in the recertification
requirements at Sec. 424.24(c)(4).
We note that there are multiple references to Sec. 424.24(c) in
the Medicare Benefit Policy Manual, Pub. 100-02, chapter 15, sections
220.1--Conditions of Coverage and Payment for Outpatient Physical
Therapy, Occupational Therapy, or Speech-Language Pathology Services,
220.1.2--Plans of Care for Outpatient Physical Therapy, Occupational
Therapy, or Speech-Language Pathology Services, and 220.1.3--
Certification and Recertification of Need for Treatment and Therapy
Plans of Care, which convey our current policy that all outpatient
physical therapy, occupational therapy, and speech-
[[Page 61738]]
language pathology services are subject to requirements for
certification and recertification at Sec. 424.24, whether furnished by
providers or by suppliers such as therapists in private practice
(TPPs). We note that while section 1835 of the Act explicitly refers to
services furnished by providers of services, which would include
hospitals and other institutional providers as defined in section
1861(u) of the Act, and clinics, rehabilitation agencies, or public
health agencies as further described in section 1835(a) of the Act, we
have interpreted the requirements of section 1835(a)(2)(C) and
1835(a)(2)(D) as applying to therapy services furnished by both
providers and suppliers. See Medicare Benefit Policy Manual, Pub. 100-
02, chapter 15, sections 220.1, 220.1.2, and 220.1.3. We believe that
this interpretation is based on the certification and recertification
requirements under section 1835(a) of the Act as a way to effectuate
the requirement in sections 1861(p), (g), and (ll)(2) of the Act that
the patient is under the care of a physician, and that the plan of
treatment/care for the physical therapy, occupational therapy, or
speech-language pathology services has been established by a physician
or by a qualified PT, OT, or SLP and is periodically reviewed by a
physician. Additionally, we thought it was important to establish
conforming policies for these therapy services in both the outpatient
provider and private practice settings.
Due to the foregoing concerns, we are proposing to revise the
headings of paragraphs (c) introductory text and (c)(1)(i) to include
the term ``occupational therapy'' after physical therapy. We propose to
replace the term speech pathology with the accepted term speech-
language pathology in 42 CFR 424.24(c)(1)(i). We are also proposing to
add the term ``occupational therapist'' to 42 CFR 424.24(c)(3)(ii)
between physical therapist and speech-language pathologist.
The regulations at 42 CFR 424.24(c) require that a physician, nurse
practitioner (NP), physician assistant (PA), or clinical nurse
specialist (CNS) who has knowledge of the case sign the initial
certification for the patient's plan of treatment. We remind readers
that plan of treatment is synonymous with the ``plan of care''
mentioned above. This terminology appears in several sections of Pub.
100-02, chapter 15, and both terms may be used interchangeably. In
accordance with Sec. 424.24(c)(2), the initial certification must be
obtained as soon as possible after the plan is established by a PT, OT,
or SLP. In Pub. 100-02, chapter 15, section 220.1.3 for Certification
and Recertification of Need for Treatment and Therapy Plans of Care, we
specify that the physician or nonphysician practitioner (NPP) must sign
the initial plan of care (POC) with a dated signature or verbal order
within 30 days from the first day of treatment, including evaluation
(or 14 days if a verbal order), in order for the PT, OT, or SLP to be
paid for the services. For this reason, the manual also states that the
therapist should forward the treatment plan to the physician/NPP as
soon as it is established rather than waiting to do so. The manual
allows for a delayed certification when the physician or NPP completes
certification and includes a reason for the delay, and delayed
certifications are accepted without justification up to 30 days after
the due date.
The regulations at Sec. 424.24(c)(4) require recertification at
least every 90 days, and the plan or other documentation in the
patient's medical record must indicate the continuing need for physical
therapy, occupational therapy, or speech-language pathology services.
The physician, nurse practitioner, clinical nurse specialist, or
physician assistant who reviews the plan must recertify the plan by
signing the medical record. Pub. 100-02, chapter 15, section 220.1.4.C
clarifies that payment and coverage conditions require that the plan of
care be reviewed as often as necessary but at least whenever it is
certified or recertified, in order to meet the certification
requirements. We explained in the CY 2008 PFS final rule, when changing
the plan of care recertification interval from 30 to 90 days, this was
done in order to allow more flexibility to the physician/NPP to order
the appropriate amount of therapy for each patient's needs (72 FR
66333). Thus, a physician or non-physician practitioner (NPP) may
certify or recertify a plan of care at an interval the physician or NPP
determines is appropriate, as long as the amount of time between each
recertification does not exceed 90 calendar days. As many episodes of
therapy treatment are completed in less than 30 calendar days, we
expect that physicians and NPPs will continue to certify plans of care
that appropriately estimate the duration of needed therapy treatment
for a patient, even if the duration is less than 90 days.
Over the past two years, representatives of several therapy-related
organizations have requested that CMS reduce the administrative burden
involved with attempting to obtain signed plans of treatment from the
physician/NPP. They expressed concern that therapists are held
accountable for the action or inaction of physicians/NPPs who may be
overwhelmed with paperwork. These interested parties report that
therapists make exhaustive efforts to obtain the physician/NPP's
signature--some reporting that they contact physician offices (via
phone, email, or fax, etc.) more than 30 times. Without the required
signature, the therapist will not meet the conditions to be paid for
the services they deliver. These interested parties recommend that
payment for therapy services should be determined by the medical
necessity of the service and whether the therapist has met their
statutory and regulatory requirements. Some of these interested parties
have noted that Pub. 100-02, chapter 15, section 220.1.1, states that
the physician/NPP order provides evidence that the patient is under the
care of a physician and that the services are medically necessary.
Interested parties told us that while CMS allows treatment to begin
before the physician's/NPP's signature is obtained, PTs, OTs, and SLPs
in private practice do so at their own risk, knowing that they might
not be paid for the services if the physician's office does not send
back the signed plan of treatment. Accordingly, such interested parties
have said that care is delayed while awaiting a physician's signature,
which could place the beneficiary's health at risk due to the delay in
obtaining outpatient therapy services.
While we do not require an order or referral for a Medicare patient
to see a PT, OT, or SLP, we have explained that the presence of a
signed order from the treating physician satisfies statutory
requirements that therapy is/was medically necessary and the patient
is/was under the care of a physician (Pub. 100-02, chapter 15, section
220.1.1). However, with this order documented in the medical record,
after the therapist evaluates the patient and establishes the plan of
treatment, based on the evaluation's findings, the therapist forwards
the patient's plan of treatment back to the referring physician/NPP to
obtain a dated signature for the same patient with the same diagnosis
to meet coverage and payment conditions to satisfy the initial
certification requirement--creating an administrative burden for both
the physician/NPP and the therapist. Interested parties have reported
to us that most patients seeking outpatient therapy services have
written orders from their physician, not to be confused with a written
plan of treatment. These interested parties have suggested that we
amend the regulation
[[Page 61739]]
at Sec. 424.24(c) to permit the presumption of a physician/NPP
signature for purposes of certification and recertification in cases
where a signed written order or referral from the patient's physician/
NPP is on file and there is written documentation in the patient's
medical record to substantiate the method and date (such as a fax,
email, etc.) that the therapist forwarded the plan of care to the
physician/NPP.
Additionally, interested parties representing all therapy
disciplines requested that CMS allot time for plan of treatment
changes. Interested parties requested that when a physician/NPP orders
the therapy services, the physician/NPP be allotted ten business days
to modify the plan of treatment by contacting the therapist directly
after receiving it from the therapist. For patients without a
physician/NPP order, interested parties requested that physician/NPPs
be given 30 days after receipt of the plan of treatment to modify the
treatment plan.
After reviewing our current regulatory requirements and considering
the suggestions of interested parties, we believe it would be
appropriate to propose to amend the regulation at Sec. 424.24(c) for
those cases when a patient has a signed and dated order/referral from a
physician/NPP for outpatient therapy services. Since our policy has
been to accept the physician or NPP's signature on the plan of
treatment to be their certification of the treatment plan's conditions
in the content requirements of Sec. 424.24(c)(1)--that the patient
needs or needed physical therapy, occupational therapy or speech-
language pathology services, the services were furnished while the
individual was under the care of a physician, NP, PA, or CNS, and the
services were furnished under a plan of treatment that meets the
requirements of Sec. 410.61--we propose that a signed and dated order/
referral from a physician/NPP combined with documentation of such
order/referral in the patient's medical record along with further
evidence in the medical record that the therapy plan of treatment was
transmitted/submitted to the ordering/referring physician or NPP is
sufficient to demonstrate the physician or NPP's certification of these
required conditions. Rather than characterizing this proposal as a
``presumption,'' we are taking the view that when the patient's medical
record includes a signed and dated written order or referral indicating
the type of therapy needed, CMS (and our contractors) would treat the
signature on the order or referral as equivalent to a signature on the
plan of treatment. We believe our proposal would be reflective of the
intent of the ordering/referring physician/NPP when that order/referral
is on file in the patient's medical record. We further believe that
this would still be consistent with the initial certification required
under section 1835(a) of the Act for providers of therapy services and
our current policy for therapy in the private practice setting. When
the ordering/referring physician writes the referral for the type of
therapy services they determine their patient needs or needed, they
also review the treatment plan the therapist established at the time it
is forwarded to them, and they verify that the services are or were
furnished while the patient is or was under their care. As such, we
propose to carve out an exception to the physician signature
requirement at Sec. 424.24(c) by adding a new paragraph (c)(5). The
proposed policy would be an exception to the physician signature
requirement for purposes of an initial certification in cases where a
signed and dated order/referral from a physician, NP, PA, or CNS is on
file and the therapist has documented evidence that the plan of
treatment has been delivered to the physician, NP, PA, or CNS within 30
days of completion of the initial evaluation. However, at this time, we
are not proposing and do not intend to establish an exception to the
signature requirement for purposes of recertification of the therapy
plan of treatment. We believe that physicians and NPPs should still be
required to sign a patient's medical record to recertify their therapy
treatment plans, in accordance with Sec. 424.24(c)(4), to ensure that
a patient does not receive unlimited therapy services without a
treatment plan signed and dated by the patient's physician/NPP.
Under our proposal, CMS or its contractors would be able to treat
the physician/NPP signature on the order or referral as equivalent to a
signature on the plan of treatment for purposes of the initial
certification if that physician/NPP has not signed and returned the
patient's plan of treatment to the therapist within 30 days of the
initial evaluation, but only in cases where the patient's physician/NPP
has signed and dated the written order or referral and indicated the
type of therapy needed, and that written order or referral is on file
in the medical record. This proposed policy would not affect a
contractor's ability or authority to determine whether therapy services
are reasonable and necessary for a given beneficiary. Lastly, because
there is no requirement for a physician/NPP order or referral for
patients to obtain outpatient therapy services, we propose to make
clear in proposed Sec. 424.24(c)(5) that the references to an order or
referral in Sec. 424.24(c)(5) shall not be construed to require an
order or referral for outpatient physical therapy, occupational
therapy, or speech-language pathology services. We welcome comments on
this proposal.
In addition, we are soliciting comments to gather more information
about the need for a regulation that would address the amount of time
for changes to plans of treatment. Our regulations at 42 CFR 410.61(d),
which are further clarified in our manual provisions in Pub. 100-02,
chapter 15, section 220.1.2.C, currently allow for changes to the
treatment plan by the physician/NPP without time restrictions.
Interested parties have suggested that CMS allow physicians/NPPs to
have just ten business days from the date of receipt of a plan of care
to modify that plan of care (in the case of a patient with an order for
the therapy services). Additionally, we are also soliciting comment as
to whether there should be a 90 calendar day time limit on the order/
referral for outpatient therapy services in cases where the order/
referral is intended to be used in relation to the proposed regulatory
amendment for the initial certification of the treatment plan at Sec.
424.24(c)(5) discussed above--that 90-day limit would span from the
order/referral date until the initial treatment of the patient,
including the evaluation furnished by the PT, OT, or SLP. We also seek
feedback about whether this limit, or one of a different duration,
should be incorporated into the regulatory provision we proposed above
for Sec. 424.24(c)(5).
We want to clarify that we are not proposing to amend Sec. 424.27
for CORF physical therapy, occupational therapy, and speech-language
pathology treatment plans to align with our proposed amendments at
Sec. 424.24 because section 1861(cc) of the Act and regulation at 42
CFR 410.105(c) require these treatment plans to be established by a
physician.
We are soliciting comments on these proposals and comment
solicitations.
3. KX Modifier Thresholds
The KX modifier thresholds were established through section 50202
of the Bipartisan Budget Act of 2018 (Pub. L. 115-123, February 9,
2018) (BBA) and were formerly referred to as the therapy cap amounts.
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
[[Page 61740]]
each year based on the percentage increase in the Medicare Economic
Index (MEI). 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
2025, we propose to increase the CY 2024 KX modifier threshold amount
by the most recent forecast of the 2017-based MEI. For CY 2025, the
proposed MEI increase is estimated to be 3.6 percent and is based on
the expected historical percentage increase of the 2017-based MEI.
Multiplying the CY 2024 KX modifier threshold amount of $2,330 by the
proposed CY 2025 percentage increase in the MEI of 3.6 percent ($2,330
x 1.036) and rounding to the nearest $10.00 results in a proposed CY
2025 KX modifier threshold amount of $2,410 for physical therapy and
speech-language pathology services combined and $2,410 for occupational
therapy services. We propose to update the MEI increase for CY 2025
based on historical data through the second quarter of 2024, and we
would use such data, if appropriate, to determine the final MEI
percentage increase and the CY 2025 KX modifier threshold amounts in
the CY 2025 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 through CY 2027. Effective beginning with CY
2028, the MR threshold levels would be annually updated by the
percentage increase in the MEI, per section 1833(g)(7)(B) of the Act.
Consequently, for CY 2025, 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 billing pattern 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 exceed one or both of the KX modifier
thresholds, therapy suppliers and providers use the KX modifier on
claims for subsequent medically necessary services. Using 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.
I. Advancing Access to Behavioral Health Services
1. Safety Planning Interventions and Post-Discharge Telephonic Follow-
up Contacts
a. Background
In the CY 2024 PFS proposed rule, we sought comment on whether
there is a need for potential separate coding and payment for
interventions initiated or furnished in the emergency department (ED)
or other crisis settings 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. Several
commenters encouraged CMS to enable wider implementation under Medicare
of the Safety Planning Intervention (SPI) and the Post-Discharge
Telephonic Follow-up Contacts Intervention (FCI) and expressed that the
current payment mechanisms are not sufficient, noting that the lack of
adequate payment mechanisms and suitable billing codes for these
interventions are barriers that are essential to address. The
commenters noted that EDs are not the only care setting where there is
need and opportunity to enhance suicide prevention, but that elevated
suicide risk is particularly prevalent among ED patients. One commenter
noted that a designated code for SPI would make it significantly easier
to document that SPI was furnished, including in quality reporting and
value-based payment programs.
More than 49,000 people died by suicide in 2022 and death by
suicide is growing significantly in older adults, who comprise most of
the Medicare population. We recognize data showing that suicide by
intentional overdose is a growing concern, particularly among young
people, older people, and Black women, although researchers acknowledge
the complexities of distinguishing intentional from unintentional
death.\143\
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\143\ https://www.nih.gov/news-events/news-releases/suicides-drug-overdose-increased-among-young-people-elderly-people-black-women-despite-overall-downward-tren.
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b. Safety Planning Interventions (SPI)
Safety planning interventions involve a patient working with a
clinician to develop a personalized list of coping strategies and
sources of support that the person can use in the event of experiencing
thoughts of harm to themselves or others. This is not a suicide risk
assessment, but rather, an intervention provided to people determined
to have elevated risk. Safety planning interventions have also been
used to reduce the risk of overdose. The basic components of a safety
plan include the following: (1) recognizing warning signs of an
impending suicidal crisis or actions that increase the risk of suicide;
(2) employing internal coping strategies; (3) utilizing social contacts
and social settings as a means of distraction from suicidal thoughts
and/or taking steps to reduce the risk of suicide; (4) utilizing family
members, significant others, caregivers, and/or friends to help resolve
the crisis; (5) contacting mental health professionals, crisis
services, or agencies; and (6) making the environment safe, including
restricting access to lethal means, as applicable.\144\ One important
aspect of making an environment safe could be,
[[Page 61741]]
for example, addressing a person's access to lethal means, such as
firearms.
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\144\ Barbara Stanley, Gregory K. Brown, Safety Planning
Intervention: A Brief Intervention to Mitigate Suicide Risk,
Cognitive and Behavioral Practice, Volume 19, Issue 2, 2012, Pages
256-264, ISSN 1077-7229, https://doi.org/10.1016/j.cbpra.2011.01.001.
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We understand that safety planning is consistent with current
practice standards and that many hospitals and clinicians in other
settings are already providing some or all of these services to the
people who need them, including through the Department of Veterans
Affairs (VA).\145\ \146\ However, in one survey of EDs, only 15.3
percent could confirm routinely implementing safety planning with all
of the structured elements mentioned above. Provision of individual
safety planning elements ranged from 24.8 percent (n = 492) to 79.2
percent (n = 1710), with 2 of 6 elements being routinely provided more
than 50 percent of the time: lists of professionals or agencies to
contact in a crisis (1710 [79.2 percent]) and helping patients to
recognize warning signs of suicide (1075 [52.2 percent]).\147\ Suicide
risk among people with substance use disorders who also are at high
risk for or may have experienced an intentional overdose is not well
recognized.\148\
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\145\ https://www.mentalhealth.va.gov/docs/vasafetyplancolor.pdf.
\146\ https://www.mirecc.va.gov/visn19/research/our-research/implementation.asp.
\147\ Bridge JA, Olfson M, Caterino JM, Cullen SW, Diana A,
Frankel M, Marcus SC. Emergency Department Management of Deliberate
Self-harm: A National Survey. JAMA Psychiatry. 2019 Jun 1;76(6):652-
654. doi: 10.1001/jamapsychiatry.2019.0063. PMID: 30865243; PMCID:
PMC6552299.
\148\ Ries RK, Livengood AL, Huh D, et al. Effectiveness of a
Suicide Prevention Module for Adults in Substance Use Disorder
Treatment: A Stepped-Wedge Cluster-Randomized Clinical Trial. JAMA
Netw Open. 2022;5(4):e222945. doi:10.1001/jamanetworkopen.2022.2945.
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Therefore, we are proposing to establish separate coding and
payment under the PFS describing safety planning interventions.
Specifically, we are proposing to create an add-on G-code that would be
billed along with an E/M visit or psychotherapy when safety planning
interventions are personally performed by the billing practitioner in a
variety of settings. We recognize that training and expertise are
needed to perform these interventions safely and appropriately and are
seeking comment regarding whether clinical staff who meet the
definition of auxiliary personnel defined at 42 CFR 410.26(a)(1) or who
are employed by a hospital could participate in furnishing this service
under the supervision of the billing practitioner in certain settings
with the relevant training needed to perform the service as well as
what sort of training would be needed.
The proposed G-code is HCPCS code GSPI1: Safety planning
interventions, including assisting the patient in the identification of
the following personalized elements of a safety plan: recognizing
warning signs of an impending suicidal crisis; employing internal
coping strategies; utilizing social contacts and social settings as a
means of distraction from suicidal thoughts; utilizing family members,
significant others, caregivers, and/or friends to help resolve the
crisis; contacting mental health professionals or agencies; and making
the environment safe; (List separately in addition to an E/M visit or
psychotherapy). We welcome comments on the proposed elements of the
safety planning code.
We are proposing to value HCPCS code GSPI1 based on the valuation
for CPT code 90839 (Psychotherapy for crisis), which describes 60
minutes, and which we believe describes a similar level of intensity as
HCPCS code GSPI1. For HCPCS code GSPI1, we are assuming a typical time
of 20 minutes, resulting in a proposed work RVU of 1.09 (based on one
third of the work value currently assigned to CPT code 90839, which is
3.28). We welcome comments on whether 20 minutes accurately captures
the typical amount of time spent with a patient on safety planning
interventions, including all six elements enumerated in this section.
Additionally, we welcome comments on whether these interventions
typically occur in the context of an encounter, such as an E/M visit or
psychotherapy, or whether there may be times when they may be furnished
as a standalone service and whether we should consider allowing this
code to be billed on its own. We also welcome comments regarding which
clinician types might be most likely to bill such a code on its own.
c. Post-Discharge Telephonic Follow-Up Contacts Intervention (FCI)
Some research suggests that patients seen in the ED with deliberate
self-harm, intentional overdose, and/or suicidal ideation have been
associated with substantially increased risk of suicide and other
mortality during the year following their visit to the ED.\149\ FCI is
a specific protocol of services for individuals with suicide risk
involving a series of telephone contacts between a provider and patient
in the weeks and sometimes months following discharge from the
emergency department and other relevant care settings, that occurs when
the person is in the community and is designed to reduce the risk for
subsequent adverse outcomes. FCI calls are typically 10-20 minutes in
duration and aim to encourage use of the Safety Plan (as needed in a
crisis) and updating it to optimize effectiveness, expressing
psychosocial support, and helping to facilitate engagement in any
indicated follow-up care and services. We note that this service would
not be within the scope of Medicare telehealth services and not subject
to the restrictions described in Section 1834(m) because these services
are specifically structured to be delivered via audio-only phone calls
and are not a substitute for an in-person service.
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\149\ Goldman-Mellor S, Olfson M, Lidon-Moyano C, Schoenbaum M.
Association of Suicide and Other Mortality With Emergency Department
Presentation. JAMA Netw Open. 2019 Dec 2;2(12):e1917571. doi:
10.1001/jamanetworkopen.2019.17571. PMID: 31834399; PMCID:
PMC6991205.
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In a recent study led by the Joint Commission, which surveyed a
national sample of hospitals to assess the prevalence of SPI and
several other recommended suicide prevention services, fewer than half
of responding hospitals reported furnishing any post-discharge follow-
up contacts. Of these, only 33 percent (16 percent of responding
hospitals overall) reported reaching discharged patients ``most of the
time.'' Further, among hospitals that furnish follow-up contacts, fewer
than half reported covering any of the main aims of FCI, for example,
41 percent review the Safety Plan, 49 percent provide psychosocial
support, and 38 percent facilitate outpatient care.\150\
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\150\ https://www.sciencedirect.com/science/article/pii/S1553725024000679?via%3Dihub.
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However, some studies have demonstrated that SPI and other services
may be able to reduce suicidal behaviors. For example, in the ED-SAFE
trial for emergency department (ED) patients identified with elevated
suicide risk, the intervention included SPI and up to seven post-
discharge follow-up calls with the patient ``focused on identifying
suicide risk factors, clarifying values and goals, safety and future
planning, facilitating treatment engagement/adherence, and facilitating
patient-significant other problem-solving.'' \151\ In the SAFE VET
study \152\ of ED patients identified with elevated suicide risk, the
intervention included SPI and at least two follow-up calls with
patients ``to monitor suicide risk, review and revise the SPI, and
[[Page 61742]]
support treatment engagement.'' \153\ Each of these studies reported
significantly lower suicide behaviors--attempts and/or deaths--among
intervention patients compared to the respective control conditions.
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\151\ Miller IW, Camargo CA Jr, Arias SA, Sullivan AF, Allen MH,
Goldstein AB, Manton AP, Espinola JA, Jones R, Hasegawa K, Boudreaux
ED; ED-SAFE Investigators. Suicide Prevention in an Emergency
Department Population: The ED-SAFE Study. JAMA Psychiatry. 2017 Jun
1;74(6):563-570. doi: 10.1001/jamapsychiatry.2017.0678. PMID:
28456130; PMCID: PMC5539839.
\152\ https://pubmed.ncbi.nlm.nih.gov/29998307/.
\153\ Stanley B, Brown GK, Brenner LA, Galfalvy HC, Currier GW,
Knox KL, Chaudhury SR, Bush AL, Green KL. Comparison of the Safety
Planning Intervention With Follow-up vs Usual Care of Suicidal
Patients Treated in the Emergency Department. JAMA Psychiatry. 2018
Sep 1;75(9):894-900. doi: 10.1001/jamapsychiatry.2018.1776. PMID:
29998307; PMCID: PMC6142908.
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In light of this, we are proposing to create a monthly billing code
to describe the specific protocols involved in furnishing post-
discharge follow-up contacts that are performed in conjunction with a
discharge from the emergency department for a crisis encounter, as a
bundled service describing four calls in a month, each lasting between
10-20 minutes. The proposed G-code is HCPCS code GFCI1: Post discharge
telephonic follow-up contacts performed in conjunction with a discharge
from the emergency department for behavioral health or other crisis
encounter, per calendar month. We seek comment on whether we should
consider finalizing a specified duration that HCPCS code GFCI1 could be
billed) following discharge, for example, allowing this code to be
billed for up to two months following discharge or whether a longer
duration would be appropriate, the number of calls per month, the
billing structure (for example, four calls for each discharged
patient), and any other relevant feedback.
We are proposing to price this service based on a direct crosswalk
to CPT code 99426 (Principal care management; first 30 minutes of
clinical staff time directed by a physician or other qualified
healthcare professional), which is assigned a work value of 1.00 work
RVUs. Since CPT code 99426 describes care management for a single
condition, we believe the work would be similar in nature and
intensity. We note that under this proposal, proposed HCPCS code GFCI1
could be billed regardless of whether proposed HCPCS code GSPI1 was
also furnished and billed for the same patient. We propose that the
billing practitioner would need to meet a threshold of at least one
real-time telephone interaction with the patient in order to bill HCPCS
code GFCI1, and that unsuccessful attempts to reach the patient would
not qualify as a real-time telephone interaction. We welcome comments
on this proposed threshold to bill HCPCS code GFCI1, recognizing that
while practitioners may attempt to reach the patient, there may be
times when the patient cannot be reached. We are also proposing that
the billing practitioner could not count time or effort more than once
for the purposes of billing this code and another service.
Additionally, as we recognize that behavioral health practitioners,
training programs, and institutions have worked conscientiously to have
risk assessment and safety planning for high-risk patients integrated
into their workflows for many years and that discharge instructions and
after visit planning may represent one of many final products from the
synthesis of all the steps involved in these encounters, we note that
we do not intend to unnecessarily disaggregate aspects of streamlined
clinical workflows that providers are successfully using to treat high
risk patients. Moreover, we also recognize that practitioners may
currently be billing for safety planning activities using existing
coding, such as E/M visits, psychotherapy, and crisis management codes
or potentially for follow-up calls using existing care management
services. However, to the extent that this intervention is part of the
standard of care, we believe that Medicare payment should accurately
reflect the additional resource costs involved in furnishing this
service.
Lastly, as applicable Part B cost sharing would apply for HCPCS
code GFCI1, we are proposing to require the treating practitioner to
obtain verbal (or written) beneficiary consent in advance of furnishing
the services described by GFCI1, which would be documented by the
treating practitioner in the medical record, similar to the conditions
of payment associated with care management and other non-face-to-face
services paid under the PFS. We note that under this proposal,
obtaining advance consent would include: (1) ensuring that the patient
is aware that Medicare cost sharing applies to these services; (2)
furnishing and receiving the necessary information to enable the
patient to receive these services (for example, obtaining the patient's
telephone number(s)); and (3) confirming that the patient consents to
the contacts.
2. Digital Mental Health Treatment (DMHT)
We are proposing Medicare payment to billing practitioners for
digital mental health treatment (DMHT) devices furnished incident to or
integral to professional behavioral health services used in conjunction
with ongoing behavioral health care treatment under a behavioral health
treatment plan of care. We are refining the digital cognitive
behavioral therapy ``digital CBT'' terminology that we have used
previously (88 FR 52262, 52370 through 52371, 88 FR 78818, 79012 and
79013). We are proposing Medicare payment to billing practitioners for
digital mental health treatment (DMHT) devices furnished incident to or
integral to professional behavioral health services used in conjunction
with ongoing. In this proposed rule we use the term ``digital mental
health treatment (DMHT) device'' to include the term ``digital CBT'' we
used in prior rulemaking and in general to refer to software devices
cleared by the Food and Drug Administration (FDA) that are intended to
treat or alleviate a mental health condition, in conjunction with
ongoing behavioral health care treatment under a behavioral health
treatment plan of care, by generating and delivering a mental health
treatment intervention that has a demonstrable positive therapeutic
impact on a patient's health. We note first that the Diagnostic and
Statistical Manual of Mental Disorders-5 (DSM) does not refer to
psychiatric disorders but to mental disorders. In this section,
following the DSM, we use the term behavioral health conditions and
mental disorders interchangeably and to mean psychiatric disorders as
referenced in FDA regulation, 21 CFR 882.5801. Second, we note that FDA
guidance refers to computerized behavioral therapy by the acronym CBT.
We aim to both provide access to vital behavioral health services and
gather further information about the delivery of digital behavioral
health therapies, their effectiveness, their adoption by practitioners
as complements in the care they furnish, and their use by patients for
the treatment of behavioral health conditions. We also recognize that
there are certain statutory limitations on payment for products under
the broader category of ``digital health interventions.'' We
acknowledge that the field of digital therapeutics is evolving and are
open to feedback from the public on this topic, including the CPT
Editorial Panel. Additionally, we recognize that historically, the CPT
Editorial Panel has frequently created CPT codes describing services
that we originally established using G codes and adopted them through
the CPT Editorial Panel process. We note that we would consider using
any newly available CPT coding to describe services similar to those
described here in future rulemaking.
a. Background
Over the last 5 years the AMA CPT Editorial Panel and CMS have
[[Page 61743]]
developed coding and separate payment for monitoring physiologic status
using software enabled devices that capture and record or transmit data
that may be reported to and interpreted by practitioners to manage a
patient under a specific treatment plan. (83 FR 59452, 59574) Medicare
payment has long been available for practitioner provision of
monitoring equipment and other kinds of devices provided incident to or
integral to the practitioner's professional services. Most recently we
have finalized payment for devices which record data related to signs,
symptoms, and functions of a therapeutic response (typically for use in
association with physical or occupational therapy care) (86 FR 64996,
65114-65116).
However, technologies that rely primarily on software, licensing,
and analysis fees, with minimal costs in equipment and hardware may not
have been typical and are not well accounted for in our practice
expense (PE) methodology. PE resources involved in furnishing services
are characterized as either direct or indirect costs. Direct costs of
the PE resources involved in furnishing a service are estimated for
each HCPCS code and include clinical labor, medical supplies, and
medical equipment. Indirect costs include administrative labor, office
expenses, and all other expenses. Indirect PE is allocated to each
service based on physician work, direct costs, and a specialty-specific
indirect percentage. The source of the specialty specific indirect
percentage is the Physician Practice Information Survey (PPIS), last
administered in 2007 and 2008, prior to the adoption of digital therapy
technologies (86 FR 65037). Nevertheless, in past rulemaking, we have
recognized that in some cases practitioners do incur resource costs for
the purchase and ongoing use of software (86 FR 65038).
In the CY 2023 PFS final rule, we finalized our proposal to accept
the RUC recommendation to contractor price CPT code 98978 (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), a PE-only device code (86 FR 69523, 69646). At the time,
specialty societies indicated that the technologies for this service
are still evolving, and that 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. There was no
professional work associated with the code.
In the CY 2024 PFS proposed rule, we requested information on
digital therapeutics for behavioral health. Among many questions, we
asked how practitioners determine which patients might be best served
by digital therapeutics and how practitioners monitor the effectiveness
of prescribed interventions on an ongoing basis once the intervention
has begun. We also asked how the treating clinician was involved in the
services received. We asked what scientific and clinical evidence of
effectiveness CMS should consider when determining whether digital
therapeutics for behavioral health, including care for substance use
disorders, depression, sleep disorders and other conditions are
reasonable and necessary. We asked whether DMHT devices were used as
incident to supplies or independent of a patient visit with a
practitioner and if practitioners in such cases issued an order for
such devices (88 FR 52262, 52370 through 52371). These factors related
to the nature of this treatment compared to other PFS services pose
challenges for fitting DMHT services into the existing benefit
structure under the PFS.
Setting appropriate pricing under the PFS has also presented
challenges. As noted previously, technologies that rely primarily on
software, licensing, and analysis fees, with minimal costs in equipment
and hardware are not well accounted for in our practice expense (PE)
methodology, even though these items may be appropriately considered
practice expenses. Consequently, over the past several years, we have
relied on a crosswalk methodology to approximate relative resource
costs for these kinds of services relative to other PFS services, or
contractor pricing.
Interested parties requested that we adopt coding specifically for
DMHT devices, where the digital software device is the actual therapy/
intervention (the algorithm software is the DMHT) as opposed to a
therapeutic monitoring device that transmits patient data as described
by CPT code 98978 for which we finalized contractor pricing in CY 2023.
Interested parties have also asked us to set national pricing for the
service to supply the DMHT device and education/onboarding that
reflects the direct practice expense incurred by practitioners when
furnishing DMHT. One of the interested parties submitted invoices to
provide data we could use as the basis to set payments for DMHT coding.
The interested party submitted four invoices reflecting considerable
variation in the cost of the DMHT treatment over 30-day and 90-day
periods. There is still more variation in pricing for comparable
products that are available for considerably lower prices in various
markets, with prices ranging from free to $140 per year, based on an
online search (https://www.carepatron.com/app/cbt-therapy-apps,
accessed March 20, 2024).
As the field of innovative products including digital therapeutics
and computerized behavioral therapy devices for psychiatric or mental
disorders develops and expands, the FDA and Substance Abuse and Mental
Health Services Administration (SAMHSA) among other agencies such as
the Veterans Health Administration (VHA) are also monitoring the
development of the field of digital therapeutic devices, including for
behavioral health purposes. For example, VHA is providing digital
behavioral health applications as self-help tools, not independent
treatment interventions. The FDA has a regulatory framework, discussed
below in this section, to classify devices and review computerized
behavioral therapy devices for psychiatric disorders.
b. Payment for Digital Mental Health Treatment (DMHT) Devices
We recognize that digital therapeutics may offer innovative means
to access certain behavioral health care services. The FDA definition
of devices encompasses software intended by the manufacturer to be
used, alone or in combination for the specific medical purpose of
diagnosis, prevention monitoring treatment or alleviation of disease
and does not achieve its primary intended action by pharmacological,
immunological or metabolic means.\154\ SAMHSA has defined digital
therapeutics (DTx) in the behavioral health context as ``health
software intended to treat or alleviate a disease, disorder, condition,
or injury by generating and delivering a medical intervention that has
a demonstrable positive therapeutic impact on a patient's health.''
\155\ SAMHSA also notes that ``DTx may be used independently or in
concert with medications, devices, or other therapies to optimize
patient care and health outcomes.'' Given nationwide behavioral health
workforce shortages combined with increasing demand for behavioral
health care services, some Medicare beneficiaries may have limited
[[Page 61744]]
access to these services.\156\ This proposal encompasses only part of
what may be a spectrum of broadly similar products, most of which might
require a new statutory Medicare benefit category. Our proposed coding
and payment policy only applies to DMHT devices that have been cleared
by the FDA. Many digital platforms and applications are marketed as
behavioral health and wellness interventions; this proposal does not
extend to such platforms and applications in part because other than
some DTx, few have evidence demonstrating improved behavioral health
outcomes.\157\
---------------------------------------------------------------------------
\154\ https://www.imdrf.org/sites/default/files/docs/imdrf/final/technical/imdrf-tech-131209-samd-key-definitions-140901.pdf.
\155\ https://store.samhsa.gov/product/advisory-digital-therapeutics-management-and-treatment-behavioral-health/pep23-06-00-001.
\156\ https://bhw.hrsa.gov/sites/default/files/bureau-health-workforce/data-research/behavioral-health-2013-2025.pdf.
\157\ https://store.samhsa.gov/product/advisory-digital-therapeutics-management-and-treatment-behavioral-health/pep23-06-00-001.
---------------------------------------------------------------------------
We propose to create three new HCPCS codes for DMHT devices modeled
on coding for RTM services. Effective beginning in CY 2025, we propose
that physicians and practitioners who are authorized to furnish
services for the diagnosis and treatment of mental illness would be
able to bill a new HCPCS code: GMBT1 (Supply of digital mental health
treatment device and initial education and onboarding, per course of
treatment that augments a behavioral therapy plan) for furnishing a
DMHT device. GMBT1 would be payable only if the DMHT device has been
FDA cleared and the billing practitioner is incurring the cost of
furnishing the DMHT device to the beneficiary. Furnishing of the DMHT
device must be incident to the billing practitioner's professional
services in association with ongoing treatment under a plan of care by
the billing practitioner. The billing practitioner must diagnose the
patient and prescribe or order the DMHT device. The patient could then
use the DMHT device at home or perhaps in an office or other outpatient
setting, if that is how the device has been cleared by FDA for use
under 21 CFR 882.5801. The DMHT device furnished must have demonstrated
a reasonable assurance of safety and effectiveness. The FDA makes a
determination of safety and effectiveness under 21 CFR 860.7. When
making this determination, the FDA will consider a variety of factors
including users, conditions of use, probable benefit to health weighed
against probable injury, and reliability. The regulation at 21 CFR
860.7, states that ``[t]here is reasonable assurance that a device is
safe when it can be determined, based upon valid scientific evidence,
that the probable benefits to health from use of the device for its
intended uses and conditions of use, when accompanied by adequate
directions and warnings against unsafe use, outweigh any probable
risks.'' GMBT1 would not be payable in cases where the billing
practitioner incurs no cost in acquiring and furnishing the DMHT
device, or a patient procures the DMHT device independent of the
practitioner. We will continue to monitor how DMHT devices are used as
part of overall care.
We seek comment about other parameters that we should consider
regarding the services described by GMBT1:
Whether payment should be made if the practitioner
furnishes a digital device that has not been cleared by FDA for mental
health treatment for a specific use, even if the digital device has
been cleared by the FDA for another specific use;
Whether payment should be made for DMHT devices cleared by
the FDA not only under 21 CFR 882.5801 but also under other
regulations;
Whether and how payment might be limited if a patient
discontinues use of the DMHT device before completing a course of
treatment; and
Whether and how payment might be limited to a set number
of DMHT devices per calendar month per patient.
In light of the pricing variability, as discussed above, we are
proposing contractor pricing for code GMBT1. We seek comment regarding
what national pricing methodology we might consider, including what
potential crosswalks would be appropriate.
We are also proposing to establish payment for two additional new
codes. These proposed codes are GMBT2 (First 20 minutes of monthly
treatment management services directly related to the patient's
therapeutic use of the digital mental health treatment (DMHT) device
that augments a behavioral therapy plan, physician/other qualified
health care professional time reviewing data generated from the DMHT
device from patient observations and patient specific inputs in a
calendar month and requiring at least one interactive communication
with the patient/caregiver during the calendar month) and GMBT3 (Each
additional 20 minutes of monthly treatment management services directly
related to the patient's therapeutic use of the digital mental health
treatment (DMHT) device that augments a behavioral therapy plan,
physician/other qualified health care professional time reviewing data
generated from the DMHT device from patient observations and patient
specific inputs in a calendar month and requiring at least one
interactive communication with the patient/caregiver during the
calendar month). Under this proposal, GMBT1 requires that the billing
practitioner who diagnosed the patient and prescribed or ordered the
DMHT device or that billing practitioner's clinical staff must monitor
the patient's therapeutic response to the DMHT device and adjust the
behavioral health therapy plan as needed. GMBT2 and GMBT3 should only
be billed when there is ongoing use of the DMHT device and should not
be billed in cases where the patient discontinues use of the DMHT
device.
For GMBT2 (first 20 minutes of monthly treatment management
services directly related to use of the DMHT device), we propose
valuing the first 20 minutes of treatment management services based on
a direct crosswalk to CPT code 98980 (remote therapeutic monitoring
first 20 minutes), which is assigned a work RVU of .62. For GMBT3 (each
additional 20 minutes of monthly treatment management services directly
related to DMHT device), we propose to value this code based on a
crosswalk to CPT code 98981 (remote therapeutic monitoring each
additional 20 minutes), which is assigned a work RVU of .61. We believe
that the work and PE described by these crosswalk codes are analogous
to the services described in GMBT2 and GMBT3, respectively, because
they include similar physician/other qualified health care professional
time in a calendar month requiring at least one interactive
communication with the patient/caregiver during the calendar month. We
welcome comments on the proposed RVUs.
3. Interprofessional Consultation Billed by Practitioners Authorized by
Statute To Treat Behavioral Health Conditions
a. Background
In the CY 2019 PFS final rule (83 FR 59489), we finalized payment
for six CPT codes regarding interprofessional consultations (99451,
99452, 99446, 99447, 99448, 99449). The six codes describe assessment
and management services conducted through telephone, internet, or
electronic health record consultations furnished when a patient's
treating physician or other qualified healthcare professional requests
the opinion and/or treatment advice of a consulting physician or
qualified healthcare professional with specific specialty expertise to
assist with the diagnosis and/or management of the patient's condition
without the need for the patient's face-to-face contact with the
consulting physician or qualified healthcare professional. We
established coding and payment for
[[Page 61745]]
these services to reflect changing healthcare practices, technology,
and the shift to treatment of chronic conditions in the Medicare
population. In the CY 2019 PFS final rule (83 FR 59491), we established
a policy to limit billing of these codes to the types of practitioners
who can independently bill Medicare for E/M visits. We did not finalize
the expansion of practitioners beyond those who can furnish E/M visits
in the CY 2019 PFS final rule due to our belief that interprofessional
consultations are primarily for the ongoing evaluation and management
of the patient, including collaborative medical decision making among
practitioners (83 FR 59491).
In the CY 2024 PFS proposed rule (88 FR 52369), we sought comment
on expanding access to behavioral health services, including whether we
should consider new coding to allow interprofessional consultation to
be billed by practitioners in specialties whose covered services are
limited by statute (Clinical psychologists at section 1861(ii) of the
Act, Clinical social workers at section1861(hh) of the Act, Marriage
and Family Therapists and Mental Health Counselors at sections
1861(lll)(1) and 1861(lll)(3) of the Act, respectively) to services for
the diagnosis and treatment of mental illness (which includes substance
use disorders). The CPT codes describing interprofessional consultation
(CPT codes 99451, 99452, 99446, 99447, 99448, 99449) are currently
limited to being billed by practitioners who can independently bill
Medicare for E/M visits. As such, they cannot be billed by clinical
psychologists, clinical social workers, marriage and family therapists,
or mental health counselors because these practitioners cannot
independently bill Medicare for E/M visits. We are proposing new codes
that would allow clinical psychologists, clinical social workers,
marriage and family therapists, and mental health counselors to bill
for interprofessional consultations with other practitioners whose
practice is similarly limited, as well as with physicians and
practitioners who can bill Medicare for E/M services and would use the
current CPT codes to bill for interpersonal consultations. These new
codes would facilitate interprofessional consultations between
treating/requesting practitioners and consultant practitioners, whether
one or both of the practitioners is in a specialty whose practice is
limited to the diagnosis and treatment of mental illness. When the
treating/requesting practitioner or consultant practitioner is a
physician or practitioner authorized to bill Medicare for E/M services,
the practitioner would continue to bill using the current CPT codes
that describe interprofessional consultation, listed previously in this
section. Depending on which practitioner type is billing, and assuming
all service requirements of the code descriptors are met, the
consulting practitioner could bill the applicable codes, either HCPCS
code (GIPC1-5) or CPT code (99451, 99452, 99446, 99447), determined by
the amount of time spent on the consultation and whether a written and
verbal consultation is provided or only a written consultation is
provided. Similarly, depending on which practitioner type is billing,
and assuming all service requirements of the code descriptors are met,
the treating/requesting practitioner could bill either HCPCS code GIPC6
or CPT code 99449 for the time spent on their referral service.
We believe that proposing payment for these interprofessional
consultations performed via communications technology such as telephone
or internet (including videoconference) is consistent with our ongoing
efforts to appropriately recognize and reflect behavioral health care
within the PFS. Currently, there is no payment mechanism to recognize
the time and effort of performing these services by clinical
psychologists, clinical social workers, marriage and family therapists,
or mental health counselors. We have also previously received comments
from interested parties that by not making separate payment for these
services, CMS would not be accurately paying for the work of both the
treating and consulting practitioner in a consultative scenario. With
the proliferation of team-based approaches to care that are often
facilitated by electronic medical record technology, we believe that
making separate payment for interprofessional consultations undertaken
for the benefit of treating a patient will contribute to payment
accuracy under the PFS for behavioral health services.
b. Coding
To further expand access to behavioral health services, we are
proposing payment for six new G codes: GIPC1 (Interprofessional
telephone/internet/electronic health record assessment and management
service provided by a practitioner in a specialty whose covered
services are limited by statute to services for the diagnosis and
treatment of mental illness, including a verbal and written report to
the patient's treating/requesting practitioner; 5-10 minutes of medical
consultative discussion and review), GIPC2 (Interprofessional
telephone/internet/electronic health record assessment and management
service provided by a practitioner in a specialty whose covered
services are limited by statute to services for the diagnosis and
treatment of mental illness, including a verbal and written report to
the patient's treating/requesting practitioner; 11-20 minutes of
medical consultative discussion and review), GIPC3 (Interprofessional
telephone/internet/electronic health record assessment and management
service provided by a practitioner in a specialty whose covered
services are limited by statute to services for the diagnosis and
treatment of mental illness, including a verbal and written report to
the patient's treating/requesting practitioner; 21-30 minutes of
medical consultative discussion and review), GIPC4 (Interprofessional
telephone/internet/electronic health record assessment and management
service provided by a practitioner in a specialty whose covered
services are limited by statute to services for the diagnosis and
treatment of mental illness, including a verbal and written report to
the patient's treating/requesting practitioner; 31 or more minutes of
medical consultative discussion and review), GIPC5 (Interprofessional
telephone/internet/electronic health record assessment and management
service provided by a practitioner in a specialty whose covered
services are limited by statute to services for the diagnosis and
treatment of mental illness, including a written report to the
patient's treating/requesting practitioner, 5 minutes or more of
medical consultative time), and GIPC6 (Interprofessional telephone/
internet/electronic health record referral service(s) provided by a
treating/requesting practitioner in a specialty whose covered services
are limited by statute to services for the diagnosis and treatment of
mental illness, 30 minutes). We welcome comments on this proposal.
Additionally, since these codes describe services that are
furnished by the treating/requesting practitioner and the consultant
practitioner without the involvement of the patient, we are proposing
to require the treating practitioner to obtain the patient's consent in
advance of these services, which would be documented by the treating
practitioner in the medical record, similar to the conditions of
payment associated with the CPT interprofessional consultation codes
and certain other non-face-to-face services paid under the PFS.
Obtaining advance patient consent includes ensuring that
[[Page 61746]]
the patient is aware that Medicare cost sharing applies to these
services, including informing the patient that there may be cost
sharing for two services (one for the treating/requesting
practitioner's service and another for the consultant practitioner's
service). We welcome comments on this proposal.
c. Valuation
We are proposing to value the six proposed new G codes based on
crosswalks to the six CPT codes for interprofessional consultations for
practitioners who can independently bill Medicare for E/M visits (CPT
codes 99451, 99452, 99446, 99447, 99448, 99449). We are proposing a
work RVU of 0.35 for GIPC1 based on a crosswalk to CPT code 99446, a
work RVU of 0.70 for GIPC2 based on a crosswalk to CPT code 99447, a
work RVU of 1.05 for GIPC3 based on a crosswalk to CPT code 99448), a
work RVU of 1.40 for GIPC4 based on a crosswalk to CPT code 99449, a
work RVU of 0.70 for GIPC5 based on a crosswalk to CPT code 99451, and
a work RVU of 0.70 for GIPC6 based on a crosswalk to 99452. Since there
are no direct PE inputs assigned to the six CPT codes describing
interprofessional consultation services on which we are basing the
proposed valuation for the new HCPCS codes GIPC1 through GIPC6, we are
not proposing any direct PE inputs for these codes. We welcome comments
on this proposal.
4. Comment Solicitation on Payment for Services Furnished in Additional
Settings, Including Freestanding SUD Treatment Facilities, Crisis
Stabilization Units, Urgent Care Centers, and Certified Community
Behavioral Health Clinics (CCBHCs)
In the CY 2024 OPPS final rule (88 FR 81809 through 81858), we
finalized payment for IOP services furnished in hospital outpatient
departments (HOPDs), Community Mental Health Centers (CMHCs), Federally
Qualified Health Centers (FQHCs), and Rural Health Clinics (RHCs), and
Opioid Treatment Programs (OTPs). We note that Section 4124 of the
Consolidated Appropriations Act (CAA), 2023, authorized payment for IOP
services in HOPDs, CMHCs, FQHCs, RHCs, and that we additionally used
existing statutory authority to propose and finalize payment for IOP
services furnished in OTPs. CMS is monitoring utilization and uptake of
IOP services in these settings. We have heard from other treatment
settings that furnish IOP services that do not fall into the categories
of HOPDs, CMHCs, FQHCs, RHCs, or OTPs, such as freestanding SUD
facilities, that have an interest in billing Medicare for these
services. In light of this, we are seeking comment on whether IOP
services are furnished in other settings in order to determine whether
potential coding and payment for IOP services under the PFS would
facilitate these services being billed in additional settings.
In particular, we are interested in feedback on the following
questions, as well as any other relevant feedback:
To what extent do freestanding SUD facilities or other
entities that furnish IOP services employ practitioner types who can
supervise auxiliary personnel and bill Medicare for their services? For
example, do they typically employ physicians, clinical psychologists,
nurse practitioners, clinical nurse specialists, certified nurse
midwives and physician assistants who are eligible to provide general
supervision to auxiliary personnel who furnish behavioral health
services?
Would bundled payments under the PFS similar to those
finalized in the CY 2024 OPPS final rule (88 FR 81809-81858) better
facilitate billing for IOP services in a broader range of settings?
If CMS outlined how freestanding SUD facilities could bill
Medicare under the PFS, would there be an impact in underserved areas?
To what extent do freestanding SUD facilities see patients
with Medicare or who are dually eligible for Medicare and Medicaid?
Additionally, we are seeking comment on entities that offer
community-based crisis stabilization, including 24/7 receiving and
short-term stabilization centers, that provide immediate access to
voluntary and/or involuntary care, without the need for a referral.
Regarding such crisis stabilization units, we are interested in
feedback on the following questions, as well as any other relevant
feedback:
++ What kind of services do crisis stabilization units provide? Do
crisis stabilization units provide services similar to those described
by the psychotherapy for crisis codes (CPT codes 90839 and 90840)?
++ Does the definition of crisis stabilization unit vary by State?
If so, what are the variations and similarities across States?
++ If CMS outlined how crisis stabilization units could bill
Medicare under the PFS, would there be an impact in underserved areas?
++ To what extent do crisis stabilization units see patients with
Medicare or who are dually eligible for Medicare and Medicaid?
++ To what extent do crisis stabilization units employ practitioner
types who can supervise auxiliary personnel and bill Medicare for their
services. For example, do crisis stabilization units typically employ
physicians, clinical psychologists, nurse practitioners, clinical nurse
specialists, certified nurse midwives and physician assistants who are
eligible to provide general to auxiliary personnel who furnish
behavioral health services?
Additionally, as a separate example, we've received information
from interested parties that there is a similar concern regarding
urgent care centers more broadly. These interested parties note that
hospital emergency departments are often used by beneficiaries to
address non-emergent urgent care needs that could be appropriately
served in less acute settings, but where other settings, such as
physician offices, urgent care centers or other clinics, are not
available or readily accessible. Patients enter EDs to treat common
conditions like allergic reactions, lacerations, sprains and fractures,
common respiratory illnesses (for example, flu or RSV), and bacterial
infections (for example, strep throat, urinary tract infections or
foodborne illness). Conditions like these often can be treated in less
acute settings. We are interested in system capacity and workforce
issues broadly and are interested in hearing more on those issues,
including how entities such as urgent care centers can play a role in
addressing some of the capacity issues in emergency departments. In
particular, we are interested in feedback on the following questions,
as well as any other relevant feedback:
What types of services would alternative settings to EDs
need to offer to meet beneficiaries' non-emergent, urgent care needs?
Does the current ``Urgent Care Facility'' Place of Service
code (POS 20) adequately identify and define the scope of services
furnished in such settings? Is this place of service code sufficiently
distinct from others such as ``Walk-in Retail Health Clinic (POS 17)
and ``Office'' (POS 11)? If not, how might these Place of Service code
definitions be modified?
Does the existing code set accurately describe and value
services personally performed by professionals and costs incurred by
the facility in these settings?
How might potential strategies to reduce overcrowding and
wait times in EDs advance equity in access to health care services?
Lastly, we are seeking comment regarding Certified Community
Behavioral Health Clinics (CCBHCs).
[[Page 61747]]
Specifically, we are interested in feedback on the following questions:
++ What kind of services do CCBHCs provide? Do they provide IOP
services, services for the treatment of substance use disorders,
psychotherapy, behavioral health integration, community health
integration, or principal illness navigation services to patients with
either Medicare or another payer?
++ If CMS outlined how CCBHCs could bill Medicare under the PFS,
would there be an impact in underserved areas?
++ To what extent do CCBHCs see patients with Medicare or who are
dually eligible for Medicare and Medicaid?
++ To what extent do CCBHCs employ practitioner types who can
supervise auxiliary personnel and bill Medicare for their services? For
example, do CCBHCs employ physicians, clinical psychologists, nurse
practitioners, clinical nurse specialists, certified nurse midwives and
physician assistants who are eligible to provide general supervision to
auxiliary personnel who furnish behavioral health services?
J. 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.'') That section of the statute also includes an
exception to allow payment to be made for inpatient hospital services
in connection with the provision of such dental services if the
individual, because of their underlying medical condition and clinical
status or because of the severity of the dental procedure, requires
hospitalization in connection with the provision of such services. Our
regulation at Sec. 411.15(i) similarly excludes payment for dental
services except for inpatient hospital services in connection with
dental services when hospitalization is required because of: (1) the
individual's underlying medical condition and clinical status; or (2)
the severity of the dental procedure.
Fee for service (FFS) Medicare Parts A and B also make payment 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. In the CY 2023 PFS final rule (87 FR
69663 through 69688), we clarified and codified at Sec. 411.15(i)(3)
that Medicare payment under Parts A and B could be made when dental
services are furnished in either the inpatient or outpatient setting
when the dental services are inextricably linked to, and substantially
related and integral to the clinical success of, other covered
services. We also added several examples of clinical scenarios that are
considered to meet that standard under Sec. 411.15(i)(3) and amended
that regulation to add more examples in the CY 2024 PFS final rule (88
FR 79022 through 79029).
In the CY 2023 PFS final rule, we also established a process
whereby we accept and consider submissions from the public (the
``public submission process'') to assist us to identify additional
dental services that are inextricably linked to, and substantially
related and integral to the clinical success of, other covered services
(87 FR 69663 through 69688). Hereafter in this section we will refer to
these services as dental services that are ``inextricably linked to
other covered services.''
We also note that the examples provided in our regulation at Sec.
411.15(i)(3)(i) are not exclusive. Medicare administrative contractors
(MACs) retain discretion to determine on a claim-by-claim basis whether
a patient's circumstances do or do not fit within the terms of the
preclusion or exceptions specified in section 1862(a)(12) of the Act
and Sec. 411.15(i).
In the CY 2024 PFS final rule, we discussed our plans to issue
educational and outreach materials to inform billing and payment for
finalized policies for dental services. We reiterated our commitment to
review submissions we receive through the public submissions process.
We also expressed our intention to continue to engage in discussions
with the public on a wide spectrum of issues relating to Medicare
payment for dental services that may be inextricably linked to other
covered services. We also described our partnership with the Agency for
Healthcare Research and Quality (AHRQ) to assist us to review available
clinical evidence and consider the relationship between dental services
and specific covered medical services and to identify other potential
clinical circumstances in which dental services are inextricably linked
to other covered services (88 FR 79029).
In this proposed rule, we (1) describe recent literature review
conducted by our partner agency, AHRQ, on the potential connection
between sickle cell disease and hemophilia and dental services; (2)
summarize submissions we received through the public submission process
for consideration in CY 2025 rulemaking; (3) propose 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 other
covered services (certain dental services for patients receiving
dialysis services to treat end-stage renal disease (ESRD)); (4) request
public comment and information related to other clinical scenarios that
may involve dental services that are inextricably linked to other
covered services; and (5) include proposals related to Medicare billing
and payment policy for dental services. We also include a request for
information regarding oral sleep apnea appliances.
b. Consideration of Dental Services That May Be Inextricably Linked to
Other Covered Services
We have partnered with AHRQ to help us consider the relationship
between dental services and other specific covered services.
Specifically, AHRQ reviews available clinical evidence regarding this
relationship, and provides analysis of clinical scenarios where dental
services may be inextricably linked to other covered services. To
better address the public's immediate dental needs, AHRQ conducted
rapid response reports instead of comprehensive assessments. With these
rapid response reports, we can better specify which payments can be
made under Medicare Parts A and B for certain dental services that are
inextricably linked to other covered services.
Through the public submissions process for consideration in CY 2024
rulemaking, interested parties nominated dental services for
individuals living with sickle cell disease (SCD) or hemophilia, urging
us to consider adding payment for these services (88 FR 52374). The
submissions included information and references supporting the
inclusion of dental services that are inextricably linked to, and
substantially related and integral to the clinical success of, the
covered services used in the treatment of SCD or hemophilia, because
such dental services serve to mitigate the substantial risk to the
success of the medical services. Submissions supported the importance
of preventing dental
[[Page 61748]]
infections among individuals with SCD to reduce the need for the
extensive procedures that may lead to bleeding complications and
hospitalization. They also provided information detailing increased
dental caries and periodontal disease in people with SCD,\158\ many of
whom lose a number of teeth, which greatly limits nutrition, general
well-being, and overall quality of life. Interested parties recommended
that we adopt a policy to allow payment for dental services for
individuals with hemophilia (88 FR 79032). They emphasized that
periodic dental care reduces the risks of dental complications that may
require hemostatic therapy or oral surgeries requiring clotting factor
replacement treatment.159 160 161 Many submitters suggested
that maintaining good oral health leads to improved outcomes for
patients with these two conditions.
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\158\ 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.
\159\ 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.
\160\ Srivastava A, Santagostino E, Dougall A, Kitchen S,
Sutherland M, Pipe SW, Carcao M, Mahlangu J, Ragni MV, Windyga J,
Llina[acute]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.
\161\ 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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Acknowledging the importance of dental health to overall well-being
of patients with these two types of diseases, in the CY 2024 proposed
rule, we summarized information provided by submitters utilizing the
public submission process and solicited comment on whether certain
dental services are inextricably linked to covered services in the
treatment of SCD (88 FR 52374). In the CY 2024 PFS final rule, we noted
that several commenters suggested expanding dental service coverage for
individuals with SCD. They supported covering dental services essential
for treating SCD, including hydroxyurea therapy. Another commenter
advocated for expanding coverage for dental services in cases of pain
crises or dental abscesses in individuals with SCD. They emphasized
that improved access to dental care could improve the quality of life
for individuals with SCD and reduce healthcare costs by enabling more
suitable treatment options and decreasing hospital stays. One commenter
questioned the clinical basis for providing dental benefits for SCD or
hemophilia due to their low prevalence in the Medicare population.
Ultimately, after consideration of public comments, we did not expand
the examples under Sec. 411.15(i)(3)(i) to include additional covered
medical services for SCD. We concluded that the information provided by
commenters did not sufficiently demonstrate that dental services are
essential to the clinical success of hydroxyurea therapy or other
treatments for SCD (88 FR 79032). Please refer to CY 2024 final rule
(88 FR 79031 through 79032) for more detailed information.
In the CY 2024 PFS proposed rule, we similarly solicited comments
on hemophilia regarding 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 for
individuals with hemophilia (88 FR 52382). Several commenters advocated
for allowing Medicare Part A and Part B payment for dental services for
individuals with hemophilia citing guidelines from Hemophilia Treatment
Centers (HTCs), the Centers for Disease Control and Prevention (CDC),
and the World Federation of Hemophilia (WFH). They emphasized the
importance of good oral health to prevent complications like gum
bleeding and major dental surgeries, especially in those with severe/
moderate hemophilia. Another commenter supported this perspective,
noting that regular dental care reduces the need for clotting factor
replacement therapy. While we acknowledged the importance of
maintaining oral health to prevent complications such as serious gum
bleeding, especially problematic for those with hemophilia, we also
reiterated that for the purposes of the PFS payment policy for dental
services inextricably linked to covered medical services, our statute
and regulations require that specific evidence supports the integral
connection between dental services and clinical success in managing
hemophilia-related medical services, and, therefore, we did not expand
the examples under Sec. 411.15(i)(3)(i) to include additional covered
medical services for hemophilia. Please refer to CY 2024 final rule (88
FR 79032 through 79033) for more detailed information.
While interested parties have suggested the interaction of oral
health care for SCD or hemophilia, we noted that further research is
necessary to find specific evidence supporting specific medical
services for which dental services are inextricably linked to their
clinical success. To gain further understanding of any potential
relationship between dental services and specific covered SCD or
hemophilia medical services, we again partnered with researchers at the
Agency for Healthcare Research and Quality (AHRQ) to review available
clinical evidence regarding the relationship between dental services
and covered SCD or hemophilia medical services. AHRQ created two rapid
response reports, which summarized recent evidence, aiming to inform
CMS policy development related to the possible linkage between dental
services and treatment modalities and services for SCD or hemophilia
patients. For more detailed information about the search strategies and
findings, please refer to the two AHRQ rapid response reports available
at https://effectivehealthcare.ahrq.gov/products/sickle-cell-dental/research and https://effectivehealthcare.ahrq.hgov/products/hemophilia-dental/research.
1. Consideration of Dental Services That May Be Inextricably Linked to
Covered Services for the Treatment of Sickle Cell Disease
As stated in the AHRQ rapid response report, SCD is a genetic
hematologic disorder affecting approximately 100,000 individuals in the
U.S.,\162\ characterized by abnormal hemoglobin formation in red blood
cells, leading to complications such as pain, infection, acute chest
syndrome, and stroke. Hydroxyurea, a commonly used therapeutic
measure,\163\ which increases fetal hemoglobin levels, which has a
higher affinity for oxygen than adult hemoglobin. This therapy can
prevent sickling or curvature of red blood cells and help SCD patients.
SCD patients can experience dental complications due to
[[Page 61749]]
ischemia,\164\ including delayed tooth eruption, enamel disorders, and
tongue cell changes. Ischemic and inflammation affects enamel, gums,
and jawbones that can cause paresthesia and tooth pain. In response to
a producing more red blood cells to make up for anemia, bone marrow
expansion can lead to malocclusion and reduced bone
density.165 166 The AHRQ's rapid response report highlights
that despite hydroxyurea's long-term use to treat SCD, uncertainty
remains regarding whether dental care before, during, or after
treatment of SCD with hydroxyurea (and other lesser prescribed
treatments) influences clinical outcomes in patients.
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\162\ Prevention CDC. Learn more about sickle cell disease,
Centers for Disease Control and Prevention. (Available at https://www.cdc.gov/ncbddd/sicklecell/.)
\163\ U.S. Food and Drug Administration. FDA approves
hydroxyurea for treatment of pediatric patients with sickle cell
anemia, U.S. Food and Drug Administration. (Available at https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-hydroxyurea-treatment-pediatric-patients-sickle-cell-anemia.)
\164\ da Fonseca M, Oueis HS, Casamassimo PS. Sickle cell
anemia: a review for the pediatric dentist. Pediatr Dent
2007;29(2):159-69. (In eng).
\165\ Hsu LL, Fan-Hsu J. Evidence-based dental management in the
new era of sickle cell disease: A scoping review. J Am Dent Assoc
2020;151(9):668-677.e9. (In eng). DOI: 10.1016/j.adaj.2020.05.023.
\166\ Kane SF. The effects of oral health on systemic health.
Gen Dent 2017;65(6):30-34. (In eng).
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In their rapid response, the Preferred Reporting Items for
Systematic Reviews and Meta-Analyses (PRISMA) flow diagram, a flow
diagram used in systematic reviews and meta-analyses intended to
describe findings of the review, revealed that initially, 762 records
were identified from large databases, and 934 records were identified
from grey literature sources covering 57 years. Following the exclusion
of ineligible studies, a total of five unique records were included,
extracted, and evaluated in the rapid response report. The rapid
response report found that no studies examined the specific impact of
dental care on SCD treatment outcomes; however, the rapid response
identified three relevant clinical practice guidelines and two reviews
with recommendations for dental care for patients with SCD. According
to the rapid response, all guidelines and reviews highlighted the
importance of preventive dental measures, with the Sickle Cell Society
in the UK recommending the inclusion of a hematologist in the dental
care team for SCD patients. However, these guidelines primarily focused
on managing SCD during dental services rather than the impact of dental
care on the improvement of SCD treatment outcomes, which differs from
the regulatory standard in Sec. 411.15(i)(3)(i) that the dental
services are inextricably linked to, and substantially related and
integral to the clinical success of, other covered services.
The two rapid reviews with recommendations highlighted several key
areas of dental management for SCD patients. They emphasized the
importance of preventive dental care to reduce the risk of oral
infections, periodontal diseases, and major dental procedures.
Additionally, the studies recommended that a complete blood count
should be evaluated prior to invasive dental procedures to mitigate
infection risks in SCD patients.167 168 Overall, the
findings from the AHRQ rapid response reports underscore the gaps in
the current literature concerning the management of oral health care
for individuals with SCD. The body of evidence evaluating dental
services before, during, or after the treatment of SCD is lacking in
primary clinical data and is limited to available clinical practice
guidelines and reviews with recommendations. While guidelines and
reviews have addressed particular aspects of dental care, such as early
intervention and the importance of collaboration between dentists and
hematologists, there is an absence of primary evidence that informed
the potential effect of dental care on SCD treatment outcomes.
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\167\ Kawar N, Alrayyes S, Yang B, Aljewari H. Oral health
management considerations for patients with sickle cell disease. Dis
Mon 2018;64(6):296-301. (In eng). DOI: 10.1016/
j.disamonth.2017.12.005.
\168\ Kakkar M, Holderle K, Sheth M, Arany S, Schiff L,
Planerova A. Orofacial Manifestation and Dental Management of Sickle
Cell Disease: A Scoping Review. Anemia 2021;2021:5556708. (In eng).
DOI:10.1155/021/5556708.
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2. Consideration of Dental Services That May Be Inextricably Linked to
Covered Services for the Treatment of Hemophilia
As stated in their report, hemophilia is a rare inherited disorder
characterized by the deficiency or absence of blood-clotting proteins,
affecting approximately 20,000-33,000 males in the U.S.\169\ There are
three distinct types of hemophilia (A, B, and C) according to the
specific clotting factor that is deficient or missing (VIII, IX, and
XI, respectively). Treatment for all three types of hemophilia is
similar but may vary based on the severity of disease, and typically
involves replacing the deficient or missing clotting factor.\170\
Anticoagulation issues in hemophilia patients can pose challenges for
dental specialists due to the increased risk of secondary bleeding
after oral surgery.\171\ Severe hemophilia patients face spontaneous
bleeding in joints, muscles, or soft tissues, sometimes life-
threatening, while mild to moderate cases may experience excessive
bleeding, including after dental extractions.\172\
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\169\ Prevention CfDCa. Hemophilia Treatment. (https://
www.cdc.gov/ncbddd/hemophilia/
treatment.html#:~:text=The%20best%20way%20to%20treat,concentrates%2C%
20into%20a%20person's%20vein.)
\170\ Ibid.
\171\ Givol N, Hirschhorn A, Lubetsky A, Bashari D, Kenet G.
Oral surgery-associated postoperative bleeding in haemophilia
patients--a tertiary centre's two decade experience. Haemophilia
2015;21(2):234-240. (In eng). DOI: 10.1111/hae.12573.
\172\ Oomen I, Camelo RM, Rezende SM, et al. Determinants of
successful immune tolerance induction in hemophilia A: systematic
review and meta-analysis. Res Pract Thromb Haemost 2023;7(1):100020.
(In eng). DOI: 10.1016/j.rpth.2022.100020.
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According to the rapid response reports provided by AHRQ, clotting
factor replacement therapy is the standard treatment for individuals
with hemophilia. Replacement therapy, which can be self-administered or
given at a hemophilia treatment center, can be used to stop a
spontaneous bleeding episode (episodic care), or to prevent bleeding
from occurring (prophylactic care). However, consistent/prolonged
factor replacement can cause antibody inhibitor development.\173\ While
clotting factor replacement therapy remains the standard treatment for
hemophilia, uncertainty persists regarding whether dental care before,
during, or after treatment of hemophilia improves clinical outcomes in
patients. Excessive bleeding, often associated with invasive or
traumatic dental procedures, poses challenges when treating patients
with hemophilia. Hence, the timing of dental treatment in relation to
factor replacement therapy may influence outcomes.
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\173\ Castaman G, Matino D. Hemophilia A and B: molecular and
clinical similarities and differences. Haematologica
2019;104(9):1702-1709. (In eng). DOI: 10.3324/haematol.2019.221093.
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In AHRQ's rapid response, a total of 1,414 records from large
databases and 2,238 records from grey literature, spanning 73 years,
were identified. Strictly following the exclusion criteria depicted in
the PRISMA diagram, the response included, extracted, and evaluated a
total of four unique publications in this rapid response. The rapid
response report identified four publications: two practice guidelines
and two reviews with recommendations. The included publications advised
hemophilia patients to consult hematologists or hemophilia treatment
centers before dental procedures. They emphasized interdisciplinary
collaboration between dentists and hematologists for treatment
planning. Included guidelines recommended performing dental services
during hemophilia treatment with coagulation factor replacement
therapy. However, all four reviewed publications mainly addressed
hemophilia A and B, with little mention
[[Page 61750]]
of hemophilia C. Similar to the findings related to SCD, the body of
evidence evaluating dental services before, during, or after the
treatment of hemophilia is lacking in primary clinical data and is
currently limited to available guidelines. These guidelines emphasize
the importance of professional dental care during hemophilia treatment
with clotting factor replacement therapy to reduce bleeding
complications, rather than the inextricable link between certain dental
services and covered services for hemophilia, which is the regulatory
standard in Sec. 411.15(i)(3)(i) for clinical scenarios under which
payment can be made for dental services under Medicare Parts A and B.
After reviewing AHRQ's comprehensive rapid reviews for both SCD and
hemophilia, we found the evidence related to the linkage between dental
services and outcomes for covered medical services for both SCD and
hemophilia lacking in the current research and literature. Both rapid
responses noted a limited number of studies examining the impact of
dental care on outcomes for individuals with SCD or hemophilia.
Currently, the evidence base does not appear to support that dental
services may be inextricably linked to covered services for SCD or
hemophilia. Also, the body of evidence evaluating dental services
before, during, or after the treatment of SCD and hemophilia lacks
primary clinical data and relies on available guidelines and reviews.
Given limited information, however, both the SCD and hemophilia rapid
responses support the need for preventive care and patient education as
essential practices for both SCD and hemophilia patients to minimize
the likelihood of oral infections, periodontal disease, and major
dental procedures. In addition, both rapid response reports recommend
collaborative efforts between dentists, hematologists, and specialized
clinics as crucial for improved patient care, despite the lack of
primary evidence informing the potential effect of dental care on
treatment. While both rapid response reports discuss their findings on
the importance of a multidisciplinary approach, both rapid response
reports also found that the current reviews and guidelines do not
address dental care as a standard of care that is inextricably linked
to hemophilia or SCD treatment. Instead, their focus was on managing
the respective conditions during dental services, not on the
inextricable linkage between the dental and medical services.
In conclusion, interested parties, including industry
organizations, public commenters, and organizations submitting through
the public submissions process, requested that CMS consider the
conditions of SCD and hemophilia for the purposes of the Medicare Parts
A and B payment policy for dental services that are inextricably linked
to other covered services. As part of our commitment to exploring the
inextricable link between dental and covered services associated with
SCD and hemophilia, we partnered with AHRQ to generate comprehensive
rapid responses on these topics. However, the AHRQ's rapid response
reports show that the current evidence base does not appear to support
that dental services may be inextricably linked to services for SCD or
hemophilia within the meaning of the standard at Sec. 411.15(i)(3),
and we are not proposing to add these conditions to our regulation.
Moreover, the findings of the AHRQ rapid response reports highlight
that this area merits further study by researchers and industry in
order to further explore potential connections between dental services
and improved outcomes for individuals with SCD or hemophilia. Given the
new and evolving therapies and treatments in this space, we will
consider conducting additional evaluations as new studies are carried
out to examining the impact of dental services on SCD and hemophilia
outcomes and will take any future studies into consideration.
We continue to seek clinical evidence demonstrating the integral
connection between dental services and other covered services for SCD
and hemophilia, and we welcome any comments or literature regarding
these two conditions. We are not proposing to amend Sec.
411.15(i)(3)(i) as we have not identified additional dental services
that are inextricably linked to certain services associated with SCD or
hemophilia. However, we remain open to considering any such services
identified by public commenters, and, if sufficient evidence is
presented, we may consider adding such services to our regulations in
the final rule. In addition, we encourage interested parties to supply
additional submissions for consideration in future PFS rulemaking
through the public submission process, which may include relevant
medical evidence, peer-reviewed literature, clinical guidelines, or
supporting documentation as described in section II.J.1.c. of this
proposed rule.
c. Submissions Received Through Public Submission Process
As we have in the CY 2023 and CY 2024 PFS final rules, we continue
to encourage interested parties to engage with us regularly and to
submit recommendations through our public submissions process for our
consideration of additional clinical scenarios where dental services
may be inextricably linked to covered services under Sec.
411.15(i)(3)(i). Through our annual public submissions process,
interested parties should provide clinical evidence and other
documentation to support their recommendations (87 FR 69685). We are
using the PFS annual rulemaking process to discuss public submissions
and to consider whether the clinical scenario described in the
submissions should be added to Sec. 411.15(i)(3)(i) as an example of a
circumstance where payment can be made for dental services inextricably
linked to other covered services. Using our annual notice and comment
rulemaking process to discuss submitted recommendations allows the
public to comment and submit further medical evidence and important
feedback 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.
We review clinical evidence included in submissions and public
comments in rulemaking, as well as information and analysis provided by
AHRQ in rapid response reports, to assess whether there is an
inextricable link between certain dental services and certain covered
services. We would find that there is an inextricable link where the
standard of care for a service is such that the practitioner would not
proceed with the procedure or service without performing the dental
service(s), for example, 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. As such, documentation accompanying recommendations
should include medical evidence to support that certain dental services
are inextricably linked to certain covered services. Specifically, as
we specified in the CY 2023 PFS final rule, we request that the medical
evidence included in submissions through the public submissions process
should:
(1) Provide support that the provision of certain dental services
leads to improved healing, improved quality of surgery outcomes, and
the reduced likelihood of readmission and/or surgical revisions because
an infection has interfered with the integration of the
[[Page 61751]]
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 other 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).
This evidence should include at least one 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).
Submissions should focus on the inextricably linked relationship
between dental services and other services necessary to diagnose and
treat the individual's underlying medical condition and clinical
status, and whether it would not be clinically advisable to move
forward with the other covered services without performing certain
dental services. To be considered for purposes of CY 2026 PFS
rulemaking, submissions through our public submissions process should
be received by February 10, 2025, via email at
[email protected]. To facilitate processing,
interested parties should include the words ``dental recommendations
for CY 2026 review'' in the subject line of their email submission. We
continue to stress to submitters that recommendations must include at
least one of the types of evidence listed earlier. We further note that
we may also consider recommendations that are submitted as public
comments during the comment period following the annual publication of
the PFS proposed rule.
We thank all those who submitted recommendations for additional
clinical scenarios for which they believe Medicare payment for dental
services will be consistent with the policies we codified at Sec.
411.15(i)(3)(i), under which Medicare payment may be made for dental
services when they are inextricably linked to other covered services.
We received thirteen submissions from various organizations and
individuals on or before February 10, 2024. Several submitters
represented dozens or hundreds of other organizations in making these
recommendations. We received one submission after the deadline that
presented nominations for clinical scenarios addressed by other
submitters, and a proposal outside the scope of clinical scenarios
where dental services may be inextricably linked to covered medical
services under Sec. 411.15(i)(3)(i).
One submitter recommended that oral health care is essential to the
success of treatments for individuals with sickle cell disease and
other hematologic disorders. The submitter asserted that providing
appropriate and timely dental care is a crucial component for the
successful treatment of many hematologic diseases, including SCD,
hemophilia, and many blood cancers, such as acute myeloid leukemia,
acute lymphoblastic leukemia, chronic lymphocytic leukemia, chronic
myeloid leukemia, and multiple myeloma. The submitter noted that we
finalized that payment can be made for certain dental services prior to
or contemporaneously with chemotherapy, CAR T-Cell therapy, and the
administration of high-dose bone-modifying agents (anti-resorptive
therapy), when used in the treatment of cancer. The evidence submitted
showed that among individuals with a sickle cell crisis, those with
dental infections were 72% more likely to be admitted to the hospital
than those without dental infections. The same submitter also requested
that we consider payment of dental services following organ
transplantations (including bone marrow or hematopoietic stem cell
transplantation (HSTC)) because maintenance of oral hygiene after HSCT
minimizes the severity of oral and dental infections, which is
important because chronic graft versus host disease (cGVHD) is common
following allogeneic HSCT. The submitter stated that frequent dental
evaluations of patients with cGVHD are critical because of the
increased rate of dental caries associated with this disease;
furthermore, gingivitis and periodontal disease should be monitored and
managed appropriately to avoid additional infection. Finally, the
submitter also stated that multiple tooth extractions without
replacement of dentition leave patients with a poor capacity to eat and
may negatively impact the success of the transplant and quality of
life. This submitter also recommended including cell and gene therapy
for SCD as a clinical treatment scenario for future consideration of
potentially inextricably linked dental services.
Another submitter asserted that patients frequently present with
complications extending three years or more following the direct
treatment of not only head and neck cancers but also other cancer
types. The submitter also asserted that a comparable trend may be seen
in patients experiencing complications following anti-resorptive drug
therapy, for non-cancer-related conditions. They recommended that
payment be available for specific dental services during a minimum of 2
years post-treatment for head and neck cancer and up to 5 years for
those who have received radiotherapy. They emphasized the current
evidence and literature as supporting the provision of Medicare payment
for a minimum of 2 years, with the understanding that some patients may
require dental or oral healthcare beyond this period due to delayed or
late-onset complications, and that the timeline for the emergence of
oral or dental complications post- treatment is not uniformly linear
and can significantly vary among patients. They also stated that
literature supports the extension of Medicare payment to include
certain dental services furnished post-anti-resorptive therapy, when
used in the treatment of cancer for at least two years following
treatment. Lastly, this submitter stated there is an inextricable risk
of the development of severe dental and oral complications, such as
osteoradionecrosis/medication-related osteonecrosis of the jaw, in
patients who have undergone the specific treatments for which we have
identified certain inextricably linked dental services. They suggested
that once patients receive these treatments, patients are perpetually
at risk for developing such complications and recommended that current
Medicare payment for dental services should align with the long-term
healthcare needs of these patients.
We are not accepting the commenters' suggestion to include specific
time limits within the exception in Sec. 411.15(i)(3). We note again
that MACs have the flexibility to determine on a claim-by-claim basis
whether payment can be made for certain dental services for
beneficiaries, such as those receiving other immunotherapies that may
involve a lymphodepleting component, consistent with Sec.
411.15(i)(3). That regulation states the general rule that
[[Page 61752]]
Medicare Parts A and B payment can be made for certain dental services
that are inextricably linked to, and substantially related and integral
to the clinical success of, covered services; and then provides a non-
exclusive list of examples of clinical scenarios under which payment
can be made. Thus, a MAC has discretion to decide on a case-by-case
basis that payment can be made for certain dental services in other
circumstances not specifically addressed under Sec. 411.15(i)(3)(i)
Several submitters recommended that we provide for payment of
medically necessary dental services for individuals with autoimmune
diseases who are initiating or undergoing immunosuppressive or
immunomodulator therapy (``immunosuppressive therapy''). They stated
that immunosuppressive therapy can be severely complicated and
compromised by oral/dental disease and conditions. The submitters
provided references to numerous clinical studies and other supporting
documentation in support of dental services in these clinical
circumstances being inextricably linked to immunosuppressive therapies
for which payment may be made in accordance with Sec. 411.15(i)(3).
They noted that while higher dosing is used for cancer chemotherapy and
organ transplant rejection prevention, the therapy's duration is
generally much shorter than when used in autoimmune disease therapy and
that the longer-term duration of use for managing symptoms of
autoimmune disease can expose patients to ongoing serious risk of
complicating infections for decades. They relayed that the American
College of Rheumatology states it is vital for patients to receive
appropriate dental evaluation and prompt treatment so they can continue
their immune suppressant medications. The submitter explained that
dental infections could spread more easily, and therefore faster, when
host immunity is compromised by immunosuppressing/immunomodulating
drugs via three pathways for the bacteria to spread: locally through
facial spaces, through the bloodstream, and by aspiration. They stated
that outcomes similar to systemic infection or sepsis and other
complications can follow for those receiving immunosuppressive therapy
to treat autoimmune diseases. They recommended immunosuppressive
therapy to treat autoimmune diseases should not proceed until a dental
or oral exam is performed to address the oral complications and/or
clear the patient of an oral or dental infection. We discuss these
recommendations and supporting evidence in section II.J.4. of this
proposed rule.
Several submitters recommended that dental treatments can be
integral to the clinical success of covered nephrology-related medical
services including services received by beneficiaries who are
immunocompromised by end-stage renal disease (ESRD), chronic kidney
disease (CKD), other renal diseases, as well as kidney transplant
candidates maintained on immunosuppressive medications. They stated
that all of these patients are at increased risk of infection,
complications, and malnutrition from dentally sourced pathogens.
Submitters stated that Medicare ESRD beneficiaries on dialysis are at
greater risk for developing complications such as cardiovascular
conditions, malnutrition, anemia, and infections, making dental
services more critical to the success of kidney care treatments. They
further stated that pre-transplantation dental care involves
eliminating possible sources of oral infection that can lead to a
systemic infection following transplant and that without access to
dental services, individuals on dialysis may not qualify for kidney
transplantation or may have severe complications after the transplant.
One of the submitters noted that dialysis clinicians report that many
bloodstream infections (BSI) begin with bacteria in the mouth and that
regular dental visits could have a positive impact on reducing BSI.
They added that the Society for Vascular Surgery has noted that
transient bacteremia from dental infections can seed hemodialysis
access grafts. Among strategies to prevent infection of vascular
grafts, recommended preoperative measures include identifying and
treating remote site infections, including dental sites. We discuss
these recommendations and supporting evidence in section II.J.2. of
this proposed rule.
More than half of the submissions expressed support for almost
identical proposals from a couple of other submitters, recommending
that dental services are inextricably linked to covered medical
services used for the treatment of Medicare beneficiaries with
diabetes. They agreed that the delivery of appropriate dental services
in accordance with clinical guidelines and standard of care is
substantially related and integral to the optimal outcome of these
covered medical services. They offered clinical studies documenting
that treatment of oral infections, such as periodontitis and its
related inflammation, meaningfully improves the treatment and
management of diabetes. They stated, by contrast, the absence of
treatment of chronic dental infections complicates covered medical
treatment for the management of diabetes and exacerbates insulin
resistance, worsens glycemic control, and other diabetes related
complications. They noted that the relationship between oral diseases
and diabetes mellitus is complex. Diabetes is known to increase the
risk and severity of oral diseases, such as periodontitis (gum
inflammation and bone loss), tooth loss, dry mouth, and oral fungal
infections. Additionally, oral diseases are documented as affecting
blood glucose control and contributing to the development of diabetes
complications, such as retinopathy, neuropathy, cardiovascular disease,
and kidney disease. They believe reciprocal management of glycemic
control and periodontal disease decreases risk for and actual cases and
severity of diabetes and periodontal disease. We discuss these
recommendations and the supporting clinical evidence in section II.J.3
of this proposed rule.
2. Proposed Additions to Current Policies Permitting Payment for Dental
Services Inextricably Linked to Other Covered Services
We have received information and requests from interested parties,
including entities submitting information through the public
submissions process as well as organizations providing comments in
response to prior rulemaking efforts, that an inextricable linkage
exists between dental services and dialysis treatment services for
individuals diagnosed with end-stage renal disease (ESRD) who are
receiving dialysis services, particularly those experiencing
comorbidities. Commenters and submitters have stated that dental
treatment is inextricably linked and integral, and substantially
related to the clinical success and outcomes of covered dialysis
medical services.
In the CY 2024 PFS final rule, we stated that commenters had
provided comments in response to the CY 2024 PFS proposed rule
supporting the coverage of annual dental examinations, and treatment as
clinically indicated, for individuals with chronic kidney disease and
ESRD. The commenters stated that chronic immunosuppression increases
the risk of dental infections leading to potentially deadly
complications including BSI, peritoneal dialysis-associated
peritonitis, and the exacerbation of chronic cardiovascular conditions.
They also stated that when established by patient-specific medical and
dental parameters, dental services can be unquestionably integral to
the
[[Page 61753]]
outcome of covered medical procedures. We thanked the commenters for
the information they submitted regarding these suggestions; however, at
that time, commenters did not provide sufficient evidence to support an
inextricable link between certain dental services and certain covered
services for chronic kidney disease and ESRD (88 FR 79034).
Additionally, submitters provided information through the public
submissions process as described in section II.J.1.c. of this proposed
rule for our consideration in CY 2025 rulemaking. The submitters stated
that there is a connection between dental services to identify and
address dental or oral infections and covered medical services for
individuals receiving dialysis in the treatment of ESRD.
ESRD is a medical condition in which a person's kidneys
successively experience loss of functionality on a permanent basis,
leading to the need for a regular course of long-term dialysis or a
kidney transplant to maintain life.\174\
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\174\ https://www.cms.gov/medicare/coordination-benefits-recovery/overview/end-stage-renal-disease-esrd.
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Chronic kidney disease (CKD) is a progressively debilitating
disease and is marked by the presence of kidney damage or reduction in
the kidneys' filtration rate. CKD is a state of progressive loss of
kidney function, in that the disease worsens over time and cannot be
reversed, ultimately resulting in the need for renal replacement
therapy, generally dialysis or transplantation.\175\ The Kidney Disease
Improving Global Outcomes (KDIGO) Foundation established guidelines
that define five stages of CKD using kidney damage markers, including
factors that determine proteinuria (level of protein in the urine) and
glomerular filtration rate (level of kidney function/filtration) in its
KDIGO 2012 Clinical Practice Guideline for the Evaluation and
Management of Chronic Kidney Disease.\176\ Chronic kidney disease is
generally defined as the presence of two factors (glomerular filtration
rate [GFR] less than 60 mL/min and albumin greater than 30 mg per gram
of creatinine) along with abnormalities of kidney structure or function
for greater than three months. Stage 5 of CKD is labeled end-stage
renal disease (ESRD) with a GFR of less than 15 mL/min.\177\ According
to the NIH, more than 500,000 people in the United States live with
ESRD.\178\
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\175\ https://www.ncbi.nlm.nih.gov/books/NBK535404/.
\176\ https://kdigo.org/wp-content/uploads/2017/02/KDIGO_2012_CKD_GL.pdf.
\177\ https://www.ncbi.nlm.nih.gov/books/NBK499861/.
\178\ https://www.ncbi.nlm.nih.gov/books/NBK499861/.
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Per the American Academy of Family Physicians, individuals with
ESRD are typically referred to nephrologists for the development of
treatment plans. Collectively the various modalities utilized to
replicate kidney function are referred to as renal replacement therapy
(RRT). Most ESRD patients are treated with dialysis, regardless of
whether transplantation ultimately occurs. Generally, kidney
transplantation typically yields the best patient outcomes; however,
not all patients with ESRD are eligible for or able to undergo
transplantation, and therefore continue dialysis treatment.\179\
Standards of medical care for CKD outline the need for monitoring for
signs of progression of the disease and early referral to specialists
for RRT.\180\ Dialysis is generally supplied via two primary modes:
hemodialysis or peritoneal dialysis. In hemodialysis, blood is filtered
through a dialyzer, outside of the body. A dialyzer is sometimes
referred to as an ``artificial kidney.''\181\ To access the circulatory
system, several access points may be placed and utilized, including an
arteriovenous (AV) fistula, AV graft, and in some cases a central
venous catheter.182 183 184 In peritoneal dialysis, a fixed
catheter is placed in the abdomen, and dialysis solution is
administered into the abdomen. The solution absorbs wastes and excess
fluid from the patient's body. 185 186
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\179\ Am Fam Physician. 2021;104(5):493-499. https://www.aafp.org/pubs/afp/issues/2021/1100/p493.html.
\180\ https://pubmed.ncbi.nlm.nih.gov/29763036/.
\181\ https://www.niddk.nih.gov/health-information/kidney-disease/kidney-failure/hemodialysis.
\182\ https://www.ncbi.nlm.nih.gov/books/NBK563296/.
\183\ https://www.mayoclinic.org/tests-procedures/hemodialysis/about/pac-20384824.
\184\ https://www.cdc.gov/dialysis/patient/.
\185\ https://www.mayoclinic.org/tests-procedures/peritoneal-dialysis/about/pac-20384725
\186\ https://www.niddk.nih.gov/health-information/kidney-disease/kidney-failure/peritoneal-dialysis.
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Submissions we received through the public submissions process for
consideration in CY 2025 rulemaking provided information regarding the
potential linkage between dental services and specific covered medical
services associated with ESRD and dialysis including:
CPT codes 36901-36906: Dialysis circuit procedures;
CPT codes 90935, 90937, 90940: Hemodialysis procedures;
CPT code 90961: Physician or other qualified healthcare
professional visits for ESRD;
CPT codes 90989-90999: Other dialysis procedures; and,
DRG code 872: Hospitalization for septicemia or severe
sepsis.
We note that Medicare provides coverage for individuals with ESRD,
regardless of age, when certain requirements are met.\187\
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\187\ https://www.cms.gov/medicare/coordination-benefits-recovery/overview/end-stage-renal-disease-esrd.
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We also note that dialysis procedures may be utilized for
individuals who do not have ESRD in the treatment of acute intoxication
or poisoning. For example, in the case of a patient experiencing
poisoning, dialysis hemoperfusion may be employed, which passes the
blood through a column packed with granules that include a resin that
act as absorbents. In this procedure, physicochemical properties of an
absorbent are used to remove toxins. Conversely, in hemodialysis
utilized in the treatment of ESRD, there is a concentration gradient
between the blood and the solvent across the dialysis membrane.\188\ We
note that the patient accessing dialysis treatment for the treatment of
acute intoxication or poisoning would not present with the same
diagnostic profile, treatment needs, nor face the same risks of
immunodeficiency and infection as individuals with ESRD as described
below.\189\
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\188\ Durakovic Z. Combined hemoperfusion and hemodialysis
treatment of poisoning with cholinesterase inhibitors. Korean J
Intern Med. 1993 Jul;8(2):99-102. doi: 10.3904/kjim.1993.8.2.99.
PMID: 8031730; PMCID: PMC4532091. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4532091.
\189\ Ouellet G, Bouchard J, Ghannoum M, Decker BS. Available
extracorporeal treatments for poisoning: overview and limitations.
Semin Dial. 2014 Jul;27(4):342-9. https://pubmed.ncbi.nlm.nih.gov/24697909/.
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Periodontal diseases and dental caries are the main chronic
infectious diseases of the oral cavity. Periodontal diseases include a
group of chronic inflammatory diseases that affect the periodontal
supporting tissues of teeth and encompass destructive and
nondestructive diseases. Gingivitis is inflammation of the soft tissue
without apical migration of the junctional epithelium. It is a
reversible, nondestructive disease that does not involve loss of
periodontal tissues. Periodontitis is inflammation of the periodontium
that is accompanied by apical migration of the junctional epithelium,
leading to destruction of the
[[Page 61754]]
connective tissue attachment and alveolar bone loss.\190\
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\190\ Albandar, J.M. (2005). Epidemiology and risk factors of
periodontal diseases. Dent Clin North Am, 49(3), 517-532, v-vi.
doi:10.1016/j.cden.2005.03.003.
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Periodontitis serves as a prime example of a disrupted balance
between the local microbiome and the host's inflammatory response, a
condition known as dysbiosis. Although the inflammatory response is
ostensibly triggered to manage the microbial threat, it proves to be
ineffective and inadequately regulated in individuals prone to the
condition. This leads to the inflammatory destruction of the
periodontium, which encompasses the tissues that encase and support the
teeth, including the gingiva, periodontal ligament, and alveolar bone.
Without appropriate treatment, this disease can progress to tooth loss,
adversely affecting chewing, appearance, and overall quality of
life.\191\
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\191\ Hajishengallis, G., & Chavakis, T. (2021). Local and
systemic mechanisms linking periodontal disease and inflammatory
comorbidities. Nature Reviews Immunology, 21(7), 426-440.
doi:10.1038/s41577-020-00488-6.
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In 2017, the American Academy of Periodontology (AAP) and the
European Federation of Periodontology (EFP) co-presented the 2017
Classification of Periodontal and Peri-Implant Diseases and Conditions.
This disease classification framework serves to guide treatment
planning for periodontitis and aims to support customized approaches to
patient care. The revised classification includes a multi-dimensional
staging and grading system for periodontitis classification, a
recategorization of various forms of periodontitis, and a
classification for peri-implant diseases and conditions.\192\
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\192\ https://www.perio.org/wp-content/uploads/2019/08/Staging-and-Grading-Periodontitis.pdf.
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Individuals with ESRD experience compromised immune systems as the
immune system and the kidneys are closely integrated and
interdependent. In healthy individuals, the kidneys contribute to
immune homeostasis and regulation, while components of the immune
system mediate many acute forms of renal disease and play a central
role in the progression of chronic kidney disease. A dysregulated
immune system can have either direct or indirect renal effects.\193\
Moreover, uremia, the buildup of waste products in the blood that
occurs as a result of declining or decreasing kidney function, can lead
to inflammation and reduction in the immune system's ability to
function as evidenced by an increased risk of viral-associated cancers,
increased susceptibility to infections, and decreased vaccination
responses in patients with ESRD.\194\ ESRD is also characterized by
diminished endocrine and metabolic functions of the kidney with
subsequent retention and accumulation of toxic metabolites.\195\
Additionally, the presence of indwelling catheters and grafts utilized
for the administration of dialysis, malnutrition, dysregulated
inflammation, and acquired immune dysfunction due to uremia contribute
to the immune deficiency in ESRD and increase susceptibility to
infection.\196\ Notably, infection is the second leading cause of death
in hemodialysis patients.197 198
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\193\ Tecklenborg J, Clayton D, Siebert S, Coley SM. The role of
the immune system in kidney disease. Clin Exp Immunol. 2018
May;192(2):142-150. doi: 10.1111/cei.13119. Epub 2018 Mar 24. PMID:
29453850; PMCID: PMC5904695.
\194\ Betjes MG. Immune cell dysfunction and inflammation in
end-stage renal disease. Nat Rev Nephrol. 2013 May;9(5):255-65. doi:
10.1038/nrneph.2013.44. Epub 2013 Mar 19. PMID: 23507826. https://pubmed.ncbi.nlm.nih.gov/23507826/.
\195\ Costantinides F, Castronovo G, Vettori E, Frattini C,
Artero ML, Bevilacqua L, Berton F, Nicolin V, Di Lenarda R. Dental
Care for Patients with End-Stage Renal Disease and Undergoing
Hemodialysis. Int J Dent. 2018 Nov 13;2018:9610892. doi: 10.1155/
2018/9610892. PMID: 30538746; PMCID: PMC6258100.
\196\ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7404977/.
\197\ U.S. Renal Data System. USRDS 2015 Annual Data Report:
Atlas of End-Stage Renal Disease in the United States, Bethesda,
National Institutes of Health, National Institute of Diabetes and
Digestive and Kidney Diseases, 2015.
\198\ Dalrymple LS, et al. Infection-related hospitalizations in
older patients with ESRD. Am. J. Kidney Dis. 2010;56:522-530. doi:
10.1053/j.ajkd.2010.04.016.
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Several submitters providing information through the public
submissions process stated that comorbidities frequently occur in the
ESRD patient population and can cause complications for the patient,
potentially jeopardizing the outcomes of the dialysis treatment. For
example, submitters stated that comorbid diabetes can result in
clinical complications for individuals receiving dialysis services in
the treatment of ESRD, stating that periodontitis can worsen blood
glucose control in diabetics by increasing levels of inflammatory
mediators and may interfere with insulin, resulting in clinical
complications. Additionally, periodontitis is associated with oral
health-related quality of life in individuals with ESRD. One study
evaluated whether periodontitis may be independently associated with
oral health-related quality of life (OHRQoL) in individuals with ESRD.
Researchers assessed 180 adults with ESRD and evaluated for impacts on
various domains, and found that periodontitis exerts an influence on
OHRQoL in individuals with ESRD, with a more severe condition impacting
different domains.\199\ Moreover, a prospective cohort study aimed to
determine the association between an index of radiographically assessed
oral health, Panoramic Tomographic Index (PTI), and cardiovascular and
all-cause mortality, major adverse cardiovascular events (MACEs) and
episodes of bacteremia and laboratory measurements during a three-year
prospective follow-up in chronic kidney disease (CKD) stage 4-5
patients not on maintenance dialysis at baseline. The study showed that
radiographically assessed and indexed dental health is independently
associated with all-cause and cardiovascular mortality and MACEs in CKD
stage 4-5 patients transitioning to maintenance dialysis and renal
transplantation during follow-up (but not with the incidence of
bacteremia).\200\
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\199\ Oliveira, L.M., Sari, D., Schoffer, C., Santi, S.S.,
Antoniazzi, R.P., & Zanatta, F.B. (2020). Periodontitis is
associated with oral health-related quality of life in individuals
with end-stage renal disease. Journal of Clinical Periodontology,
47(3), 319-329. doi:10.1111/jcpe.13233.
\200\ Jarvisalo, M.J., Jokihaka, V., Hakamaki, M., Lankinen, R.,
Helin, H., Koivuviita, N.S., . . . Metsarinne, K. (2021). Dental
health assessed using panoramic radiograph and adverse events in
chronic kidney disease stage 4-5 patients transitioning to dialysis
and transplantation-A prospective cohort study. PLOS ONE, 16(9),
e0258055. doi:10.1371/journal.pone.0258055.
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Submitters providing information through the public process also
stated that BSI, poor glycemic control, and other complications arising
from dental infection can jeopardize the clinical success of medical
therapies employed to manage ESRD. Research provided by submitters
described that issues and changes in the mouth and oral cavity, such as
periodontitis and other consequences of poor oral health, frequently
occur in patients with CKD and may contribute to increased morbidity
and mortality because of systemic consequences such as inflammation,
infections, protein-energy wasting, and atherosclerotic
complications.\201\
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\201\ Harun Akar, Gulcan Coskun Akar, Juan Jesus Carrero, Peter
Stenvinkel, and Bengt Lindholm. Systemic Consequences of Poor Oral
Health in Chronic Kidney Disease Patients, Clin J Am Soc Nephrol 6:
218-226, 2011. doi: 10.2215/CJN.05470610.
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Several submitters also stated that addressing oral health issues,
including identifying and resolving dental infections through the
provision of dental and oral services, can be inextricably linked and
integral and related to the clinical success of Medicare covered
dialysis services for the treatment of ESRD. The submitters
[[Page 61755]]
stated that the consequences of poor oral health are worse for ESRD
patients than the general population due to ESRD patient
characteristics such as advanced age, higher prevalence of comorbid
diabetes, polypharmacy, and impaired immune function, and that
medically necessary dental care may improve the clinical success of the
dialysis services.
A few submitters supplied a general position paper on the need for
dental care and services in the ESRD patient population receiving
dialysis services, describing the unique risks for individuals with
ESRD and the increased risk of infection from oral sources.
Specifically, the position paper states that ``oral diseases represent
a potential and preventable cause of poor health outcomes in people
with ESRD due to their relation to infection, inflammation, and
malnutrition. Oral health represents a potential determinant of health
outcomes in patients with end-stage renal diseases (ESRD).''\202\
Several submitters also provided a cohort outcomes study of 675
randomly selected individuals receiving peritoneal dialysis
services.\203\ The study outcomes described that ``poor oral health was
associated with lower educational levels, diabetes, older age,
marriage, and worse nutritional indicators (including lower time-
averaged serum albumin and phosphate concentrations).''\204\
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\202\ Costantinides F, Castronovo G, Vettori E, Frattini C,
Artero ML, Bevilacqua L, Berton F, Nicolin V, Di Lenarda R. Dental
Care for Patients with End-Stage Renal Disease and Undergoing
Hemodialysis. Int J Dent. 2018 Nov 13;2018:9610892. doi: 10.1155/
2018/9610892. PMID: 30538746; PMCID: PMC6258100.
\203\ Sirirat Purisinsith, Patnarin Kanjanabuch, Jeerath
Phannajit, Bruce Robinson, Kriang Tungsanga, et al. ``Oral Health-
Related Quality of Life, A Proxy of Poor Outcomes in Patients on
Peritoneal Dialysis.'' doi: https://doi.org/10.1016/j.ekir.2022.07.008 (August 5, 2022).
\204\ Ibid.
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The research further isolated that poor oral health is
independently associated with an increased risk of peritonitis, an
infection of the peritoneum where the peritoneal access graft is
placed, and mortality in patients receiving peritoneal dialysis. The
authors describe that ``after adjusting for age, sex, comorbidities,
serum albumin, shared frailty by study sites, and PD vintage, poor oral
health was associated with increased risks of peritonitis (adjusted
hazard ratio [HR] = 1.45, 95 percent confidence interval [CI]: 1.06-
2.00) and all-cause mortality (adjusted HR = 1.55, 95 percent CI: 1.04-
2.32) but not hemodialysis (HD) transfer (adjusted HR = 1.89, 95
percent CI: 0.87-4.10) compared to participants with good oral
health.'' Furthermore, the study explained that ``poor oral health
status was present in one-fourth of peritoneal dialysis patients and
was independently associated with a higher risk of peritonitis and
death.''\205\ Moreover, submitters provided information that suggests
that patients with ESRD receiving hemodialysis services and receiving
preventive oral and dental services experience increased survival while
those not receiving dental services were associated with increased
mortality. A prospective cohort outcomes study of 4,205 hemodialysis
patients assessed the impact of dental health on mortality from 2010 to
2012. The study described that ``in adults treated with hemodialysis,
poorer dental health was associated with early death, whereas
preventive dental health practices were associated with longer
survival.''\206\
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\205\ Ibid.
\206\ See, e.g., Palmer S.C., Ruospo M., Wong G., et al. Oral-D
study investigators. Dental health and mortality in people with end-
stage kidney disease treated with hemodialysis: a multinational
cohort study. American Journal of Kidney Diseases. 2015;66:666-676.
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Additionally, in a systematic review supplied by several
submitters, studies show that patients on RRT (for example
hemodialysis, peritoneal dialysis, and/or transplantation) experience a
high prevalence of dental caries, common chronic infection resulting
from tooth-adherent cariogenic bacteria.\207\ The observational data
presented in the review suggests a link between oral health and
mortality in patients on RRT.\208\ The review highlighted the need for
further research in this area but also stated that improved,
multidisciplinary, patient-centered dental care concepts are required
to support dental and overall oral health in individuals on RRT.
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\207\ https://www.ncbi.nlm.nih.gov/books/NBK551699/.
\208\ Deborah Kreher et.al., Prevalence of Dental Caries in
Patients on Renal Replacement Therapy--A Systematic Review J. Clin.
Med. 2023, 12, 1507. https://doi.org/10.3390/jcm12041507.
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Several submitters also noted that the Society for Vascular Surgery
has stated that transient bacteremia from dental infections can seed
hemodialysis access grafts. Among strategies to prevent infection of
vascular grafts, recommended preoperative measures include identifying
and treating remote site infections, including dental or oral sites of
infection.209 210 Statements regarding best practices for
managing infection control advise that sources of infection, including
those within the oral cavity, should be addressed in order to minimize
the risk of broader infection in the ESRD patient receiving
hemodialysis.\211\
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\209\ Surgical Site Infection Toolkit, CDC, SSI Toolkit Activity
C: ELC Prevention Collaboratives (cdc.gov).
\210\ Pear S, Patient Risk Factors and Best Practices for
Surgical Site Infection Prevention, https://www.halyardhealth.com/wp-content/uploads/patient_risk_factors_best_practices_ssi.pdf.
\211\ Ibid.
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In conclusion, the evidence base indicates that evaluation for and
treatment of oral infection leads to improved outcomes and reduced risk
of mortality for individuals with ESRD receiving covered dialysis
services.
In the CY 2023 PFS final rule, we agreed with commenters that there
is clinical evidence to support that medically necessary dental care
may advance the clinical success of organ transplants and finalized
that payment can be made under Medicare Parts A and B for dental
services such as dental examinations, including necessary treatment,
performed as part of a comprehensive workup prior to organ transplant
surgery and medically necessary diagnostic and treatment services
immediately necessary to eliminate or eradicate the infection or its
source that are provided before transplantation because such services
are inextricably linked to, and substantially related and integral to
the clinical success of, the organ transplant procedure (87 FR 69676).
Furthermore, we stated that we appreciated commenters' feedback
regarding those individuals who are awaiting organ transplantation and
the commenters' request that Medicare provide payment for medically
necessary dental services prior to transplantation. We described that
in a case where an individual is awaiting organ transplantation, we
believe that it is appropriate for Medicare to provide payment for,
including but not limited to, an oral or dental examination, and
medically necessary diagnosis and treatment for only those services
that are considered immediately necessary to eliminate or eradicate the
infection or its source prior to the organ transplant (87 FR 69676).
In consideration of research and 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
dialysis services for individuals with ESRD, we believe that dental
services to diagnose and treat infection prior to dialysis services in
the treatment of ESRD represent a clinically analogous scenario to
dental services for which Medicare payment under Parts A and B is
currently permitted when furnished in the
[[Page 61756]]
inpatient or outpatient setting, such as prior to organ transplant. The
clinical evidence supports that the medically necessary dental care may
similarly advance the clinical success of dialysis services in the
treatment of ESRD because an oral or dental infection can present
substantial risk to the success and outcomes of these procedures
(including the risk of systemic infection, BSI, sepsis, and death).
As such, we believe that if a patient requiring dialysis services
in the treatment of ESRD has an oral infection, the success of those
dialysis services could be compromised if the infection is not properly
diagnosed and treated prior to the covered medical services. Without an
oral or dental examination to identify such an infection and the
provision of necessary treatment, such as restorative dental services,
to eradicate the infection prior to the dialysis procedure, the
patient's ability to complete the dialysis services could be seriously
complicated or compromised and the risk of infection would further
increase the risk of mortality for the patient.
Examples of restorative dental services to eradicate infection
could include: extractions (removal of the entire infection, such as
pulling of teeth--for example, CDT D7140, D7210), restorations (removal
of the infection from tooth/actual structure, such as fillings--for
example, CDT D2000-2999), periodontal therapy (removal of the infection
that is surrounding the tooth, such as scaling and root planning--for
example, CDT D4000-4999, more specifically D4341, D4342, D4335 and
D4910), or endodontic therapy (removal of infection from the inside of
the tooth and surrounding structures, such as root canal--for example,
CDT D3000-3999).
If such an infection is not treated prior to dialysis services in
the treatment of ESRD, then there is an increased likelihood for
morbidity and mortality resulting from spreading of the local infection
to BSI and sepsis. Likewise, we believe that infections occurring
during the course of dialysis treatment should similarly be addressed
and resolved in order to minimize the risk of infection and death for
the patient with ESRD receiving dialysis services.
Because an oral or dental infection can present substantial risk to
the success of dialysis treatment for ESRD, we believe dental services
furnished to identify, diagnose, and treat oral or dental infections
prior to or contemporaneously with dialysis services in the treatment
of ESRD are not in connection with the care, treatment, filling,
removal, or replacement of teeth or structures directly supporting
teeth, but instead are inextricably linked to, and substantially
related and integral to the clinical success of, these other covered
medical services. We note that, in these circumstances, the necessary
treatment to eradicate an infection may not be the totality of
recommended dental services for a given patient. For example, if an
infected tooth is identified in a patient requiring dialysis services
in the treatment of ESRD, the necessary treatment would be to eradicate
the infection, which could result in the tooth being extracted.
Additional dental services, such as a dental implant or crown, may not
be considered immediately necessary to eliminate or eradicate the
infection or its source prior to surgery. Therefore, such additional
services would not be inextricably linked to, and substantially related
and integral to the clinical success of, Medicare-covered dialysis
services when used in the treatment of ESRD. As such, no Medicare
payment would be made for the additional services that are not
immediately necessary prior to or contemporaneously with dialysis for
ESRD to eliminate or eradicate the infection.
In conclusion, 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 at paragraph A to
include dental or oral examination performed as part of a comprehensive
workup in either the inpatient or outpatient setting prior to Medicare-
covered dialysis services when used in the treatment of ESRD; and
medically necessary diagnostic and treatment services to eliminate an
oral or dental infection prior to, or contemporaneously with Medicare-
covered dialysis services when used in the treatment of ESRD. We seek
comments on all aspects of this proposal.
3. Request for Comment on Dental Services Integral To Specific Covered
Services to Treat Diabetes
As described in section II.J.1.c. of this proposed rule, we have
received information from interested parties, including submitters
providing evidence through the public submissions process as well as
commenters on prior proposed rules suggesting that dental services are
inextricably linked to treatment services for individuals with diabetes
mellitus. Several interested parties using the public submissions
process have urged us to provide Medicare payment for dental services
for individuals diagnosed with diabetes for consideration in CY 2025
rule making. These submissions included information and references
supporting oral and dental treatment of advanced periodontitis among
individuals with diabetes to improve markers related to management of
the diabetes.
Submitters stated that clinical studies demonstrate that dental
treatments for oral infections, such as advanced periodontitis and
related inflammation, meaningfully advance and improve the treatment
of, management of, and outcomes for patients with diabetes. Submitters
also stated that conversely, the absence of treatment of chronic dental
infections in turn complicates covered medical treatment for the
management of diabetes and potentially exacerbates insulin resistance,
worsens glycemic control, and other diabetes-related complications,
leading to poor outcomes for the individuals with diabetes. Submitters
also noted that studies demonstrate cost savings when dental services
are employed in the treatment of individuals with diabetes and also
serve to advance health equity among vulnerable populations.
Submitters provided information detailing the increased risk of
dental caries and periodontal disease in people with diabetes, many of
whom lose teeth, which greatly limits nutrition, general well-being,
and overall quality of life. Submitted studies demonstrated the
bidirectional nature of periodontal disease and diabetes, suggesting
that both conditions influence each other and can worsen or conversely
improve outcomes.
As described by submitters, numerous basic and clinical studies
describe the relationship between oral diseases and inflammation in
persons with diabetes, which increases risks for micro- and
macrovascular complications including retinopathy, nephropathy,
neuropathy, cardiovascular diseases, and stroke. Several submitters
stated that there is a documented reduction in hospitalizations in
persons with diabetes who receive conservative periodontal treatment.
Consequently, submitters stated that periodontal treatment is
recommended for patients with diabetes by American Diabetes Association
Clinical Guidelines and is also promoted by the American Association of
Clinical Endocrinologists and others.\212\
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\212\ Nuha A. El Sayed, Grazia Aleppo, Vanita R. Aroda,
Raveendhara R. Bannuru, Florence M. Brown, Dennis Bruemmer, Billy S.
Collins, Kenneth Cusi, Sandeep R. Das, Christopher H. Gibbons, John
M. Giurini, Marisa E. Hilliard, Diana Isaacs, Eric L. Johnson, Scott
Kahan, Kamlesh Khunti, Mikhail Kosiborod, Jose Leon, Sarah K. Lyons,
Lisa Murdock, Mary Lou Perry, Priya Prahalad, Richard E. Pratley,
Jane Jeffrie Seley, Robert C. Stanton, Jennifer K. Sun, Crystal C.
Woodward, Deborah Young-Hyman, Robert A. Gabbay; on behalf of the
American Diabetes Association, Summary of Revisions: Standards of
Care in Diabetes--2023. Diabetes Care 1 January 2023; 46
(Supplement_1): S5-S9. https://doi.org/10.2337/dc23-Srev.
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[[Page 61757]]
Diabetes mellitus is a chronic, metabolic disease characterized by
elevated levels of blood glucose (or blood sugar), which, over time,
may lead to serious damage to the heart, blood vessels, eyes, kidneys,
and nerves. Type 2 diabetes, which usually occurs in adults, causes the
body to become resistant to insulin or not to make enough insulin. Type
1 diabetes, previously referred to as juvenile diabetes or insulin-
dependent diabetes, is a chronic condition in which the pancreas
produces little or no insulin.\213\
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\213\ https://www.who.int/health-topics/diabetes.
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A primary goal for the treatment of diabetes is glycemic control
and requires accurate individualization and customization of available
treatment options. Interventions to address lipoproteins, blood
pressure, weight control, mental health, and lifestyle are important
factors that contribute to quality of life and the frequency of
diabetes-associated complications.\214\ According to recent statistics
from the Centers for Disease Control and Prevention, approximately 38
million people in the United States may have diabetes, and the CDC
estimates that 1 in 5 of them do not know they have the condition.
Approximately 98 million U.S. adults likely have prediabetes, and more
than 8 in 10 of them may not know they have prediabetes. Notably,
diabetes is the eighth leading cause of death in the United States (and
may be underreported). Type 2 diabetes accounts for approximately 90 to
95 percent of all diagnosed cases of diabetes, while Type 1 diabetes
accounts for approximately 5-10 percent. The CDC reports that over the
last 20 years, the number of adults diagnosed with diabetes has more
than doubled as the American population has aged and become more
overweight or obese.\215\
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\214\ Melmer A, Laimer M. Treatment Goals in Diabetes. Endocr
Dev. 2016;31:1-27. doi: 10.1159/000439364. Epub 2016 Jan 19. PMID:
26824869.https://pubmed.ncbi.nlm.nih.gov/26824869/.
\215\ https://www.cdc.gov/diabetes/basics/quick-facts.html.
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One key marker for the measurement of glycemic control, a key goal
in the treatment of diabetes, in individuals with diabetes is the
hemoglobin A1c test. The hemoglobin A1c (also referred to as glycated
hemoglobin, glycosylated hemoglobin, HbA1c, or A1c) test is used to
evaluate a person's level of glucose control and shows an average of
the blood sugar level over the past 90 days and represents a
percentage.\216\
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\216\ https://www.ncbi.nlm.nih.gov/books/NBK549816/.
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Submitters through the public submissions process provided multiple
research studies regarding the interaction between dental services and
outcomes for medical services to treat diabetes. The Cochrane Library
(ISSN 1465-1858) is a collection of databases that contain high-
quality, independent evidence to inform healthcare decision-making. The
Cochrane Library is owned by Cochrane and published by Wiley.\217\ In
the Cochrane Review entitled Treatment of periodontitis for glycaemic
control in people with diabetes mellitus, evidence from 30 trials
(results from 2,443 participants) showed that periodontitis treatment
reduces blood sugar levels (measured by HbA1c) in diabetic patients on
average by 0.43 percentage points (for example, from 7.43 to 7 percent;
4.7 mmol/mol) 3 to 4 months after receiving the treatment compared with
no active treatment or usual care. A difference of 0.30 percent (3.3
mmol/mol) was seen after 6 months (12 studies), and 0.50 percent (5.4
mmol/mol) at 12 months (one study).\218\ All studies in the review used
a parallel randomized controlled trials (RCT) design and followed
participants for between 3 and 12 months. The studies generally focused
on people with type 2 diabetes, save one study that included
participants with type 1 or type 2 diabetes. Most studies were mixed in
terms of whether metabolic control of participants at baseline was
good, fair, or poor and were carried out in secondary care. Researchers
compared periodontitis treatment with control, which could be no (or
delayed) treatment or usual care (oral hygiene instruction (OHI) or
supragingival scaling with or without OHI). The degree and nature of
advanced periodontitis were not specifically defined in the context of
the studies. Additionally, the studies did not control for other types
of interventions deployed in the treatment of diabetes (that is,
strategies used to manage glycemic control), so patients may have been
receiving other types of treatment during the study periods.
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\217\ https://www.cochranelibrary.com/about/about-cochrane-library.
\218\ Simpson TC, et al. Treatment of periodontitis for
glycaemic control in people with diabetes mellitus. Cochrane
Database Syst Rev. 2022;4:CD004714 https://www.ncbi.nlm.nih.gov/pubmed/35420698.
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The types of periodontal treatment provided covered a wide range of
oral services: subgingival instrumentation, surgical periodontitis
treatment-flap surgery or gingivectomy; antimicrobial therapy
(encompassing antibacterials and antibiotics), either locally applied
(including mouth rinses, gels, or dentifrices) or systemically
administered; other drug therapy with a possible benefit of improving
the periodontal condition of the participant; other novel interventions
to manage periodontitis; supragingival scaling (also known as
professional mechanical plaque removal (PMPR)); oral hygiene
instruction; and/or, education or support sessions to improve
self[hyphen]help or self[hyphen]awareness of oral hygiene.
In summary, the Cochrane review demonstrated that individuals with
diabetes who have periodontitis who receive dental services for the
treatment of the periodontitis experience a statistically significant
reduction of HbA1c. Again, measurement of HbA1c is a metric for gauging
glycemic control and is a primary goal of treatment for all individuals
with diabetes. The study suggests that individuals with diabetes who
also have a diagnosis of periodontitis who receive treatment to address
the periodontitis subsequently experience a reduction in HbA1c. The
study authors described the clinical outcomes related to preventive
dental care, conservative periodontal treatment, and reduction in HbA1c
as statistically and clinically significant. Moreover, the authors of
the research stated that ``further trials evaluating no treatment vs
usual care are unlikely to change this conclusion.'' \219\
---------------------------------------------------------------------------
\219\ Simpson TC, et al. Treatment of periodontitis for
glycaemic control in people with diabetes mellitus. Cochrane
Database Syst Rev. 2022;4:CD004714 https://www.ncbi.nlm.nih.gov/pubmed/35420698.
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Submitters providing information through the public submissions
process suggested that dental services could be inextricably linked to
the following specific medical services in the treatment of diabetes:
CPT 36901-36906: Dialysis circuit procedures.
CPT 82947: Chemistry procedures, blood glucose testing.
CPT 83036: Hemoglobin A1C testing.
CPT 90935, 90937, 90940: Hemodialysis procedures.
CPT 90961: Physician or other qualified healthcare
professional visits for ESRD.
[[Page 61758]]
CPT 90989-90999: Other dialysis procedures.
CPT 92227-92229: Diabetic retinopathy screening.
CPT 99091: Collection and interpretation of physiologic
data.
CPT 99202-99215: Evaluation and Management (E/M) Services.
CPT 99211: Office visit for an established patient.
CPT 99487: Complex chronic care management services.
CPT 99490-99491: Chronic care management services.
CPT 99497: Remote physiologic monitoring services.
CPT 99605-99607: Medication Management.
CPT 99802-99804: Assessment, Intervention, Face to Face
(F2F).
DRG 637: Hospitalization for diabetes with major
complications.
G0108: Diabetes Self-Management Training.
G0109: Group Diabetes Self-Management Training.
G0270: Nutrition Therapy.
G0466: FQHC visit new patient.
G0467: FQHC visit established patient.
As described in this section, research provided by submitters
suggests that periodontal treatment for an individual with both a
diagnosis of diabetes and periodontitis led to improved HbA1c measures.
We have explained that there are instances where dental services
are so integral to other medically necessary services that they are
inextricably linked to the clinical success of that medical service(s),
and, as such, they are not in connection with the care, treatment,
filling, removal, or replacement of teeth or structures directly
supporting teeth within the meaning of section 1862(a)(12) of the Act.
Rather, these dental services are inextricably linked to the clinical
success of an otherwise covered medical service and are payable under
Medicare Parts A and B.
In the case of an individual with diabetes who also has a diagnosis
of periodontitis, oral services and treatment to address the
periodontitis potentially lead to a reduction in HbA1c, a marker of
glycemic control that may be used to determine the effectiveness of
interventions for treatment of diabetes. In the description of the
studies submitted, the research seems to indicate that the improvement
of glycemic control as evidenced by the HbA1c is due to the provision
of treatment for the periodontitis. The dental and oral services may
not be integral to other specific medically necessary, covered
services, but rather the dental and oral services may serve to
influence clinical outcomes directly. The studies compare the impact of
the treatment for the periodontitis to the impact of pharmacological
interventions.
We recognize that evidence submitted by interested parties
demonstrates that an individual with both a diagnosis of diabetes and a
diagnosis of periodontitis who in turn receives periodontal treatment
services may experience improvements in markers for HbA1c, which is a
key target outcome for the patient population with diabetes. However,
the interaction between these diagnoses and the potential improvements
due to periodontal treatment services does not appear to align with the
framework we have established to pay for dental services inextricably
linked to covered services; in our framework, the delivery of certain
dental services are integral to the successful completion of or
outcomes related to the covered services.
Under Sec. 411.15(i)(3), we have specified that payment can be
made for certain dental services that are inextricably linked to other
services when the specific covered services with which the dental
services are inextricably linked are identified. The studies that have
been provided to CMS through submissions have not identified any
specific covered services for the treatment of diabetes to which dental
services are inextricably linked. Rather, the studies indicate that the
primary treatment of periodontal disease in patients with diabetes
generally leads to better outcomes in the management of the patients'
diabetes. While the research makes the case that the dental services
are medically necessary for patients with diabetes, medical necessity
alone does not permit payment for dental services given the broad
statutory prohibition under section 1862(a)(12) on payment for services
``in connection with the care, treatment, filling, removal, or
replacement of teeth or structures directly supporting teeth.'' In the
case of patients with diabetes, the research does not appear to show
that certain dental services are inextricably linked with certain other
covered services for the treatment of diabetes, in accordance with our
regulation at Sec. 411.15(i)(3) such that the statutory prohibition
under section 1862(a)(12) does not apply.
We note that some of the examples of medical services for diabetes
treatment provided by submitters are general in nature and not specific
to patients with diabetes who may also have periodontal disease,
including CPT codes 99202-99215: Evaluation and Management (E/M)
Services that broadly describe outpatient office visits for the
diagnosis and medical management of practically any illness, disease,
or condition.
Additionally, submitters providing evidence for our consideration
suggested that the services described by codes for diabetes self-
management training (for example, G0108: Diabetes Self-Management
Training, and G0109: Group Diabetes Self-Management Training) are
services with which dental services may be inextricably linked.
However, we were not persuaded by this evidence and do not believe that
dental services would be inextricably linked to improved outcomes for
services for DSMT. Therefore, we seek comment from the public regarding
specific covered services for management of patients with diabetes with
which dental services may be inextricably linked. At this time, we are
not proposing to amend Sec. 411.15(i)(3)(i) as we have not identified
additional dental services that are inextricably linked to certain
services in the treatment of diabetes. However, we note that we remain
open to considering any such services identified by public commenters,
and, if sufficient evidence is presented, we may consider adding such
services to our regulations in the final rule.
In the context of payment for dental services for an individual
with diabetes, we seek information from the public regarding what the
coordination between a medical and dental professional would entail in
the scenario where an individual with a diagnosis of diabetes presents
with suspected periodontitis. In the CY 2023 PFS final rule, we
explained that we would make payment when a doctor of dental medicine
or dental surgery (referred to as a dentist) furnishes dental services
that are an integral part of the covered primary procedure or service
furnished by another physician, or non-physician practitioner, treating
the primary medical illness. However, if there is no exchange of
information, or integration, between the medical professional
(physician or other non-physician practitioner) in regard to the
primary medical service and the dentist in regard to the dental
services, then there would not be an inextricable link between the
dental and covered medical service within the meaning of our regulation
at Sec. 411.15(i)(3). Without both integration between the Medicare
enrolled medical and dental professional, and the inextricable link
between the dental and covered services, Medicare payment for dental
services would be prohibited under section 1862(a)(12) because the
services
[[Page 61759]]
are in connection with the care, treatment, filling, removal, or
replacement of teeth or structures directly supporting teeth; though
they may be covered by types of supplemental health or dental coverage
(87 FR 69687 through 69688).
In a situation where a medical professional believes that an
individual with a diagnosis of diabetes may also have a diagnosis of
periodontitis, how are recommendations conveyed between the medical and
dental professionals? What coordination, if any, occurs between the
medical and dental professionals? We expect that inextricably linked
services related to the treatment of periodontitis in an individual
with diabetes would require significant communication between the
medical and dental professionals.
Additionally, we have stated that an inextricable linkage may exist
between dental services and covered services when the standard of care
for the medical service is such that the practitioner would not proceed
with the medical procedure or service without performing the dental
services, because the covered medical services would or could be
significantly and materially compromised, or where dental services are
a clinical prerequisite to proceeding with the primary medical
procedure and/or treatment (87 FR 69669). While evidence supports that
individuals with diabetes and periodontitis who receive periodontal
treatment experience improvements in their HbA1c markers, dental
services do not appear to serve as a precondition to overall treatment
for the diabetes. We seek information from the public on how oral
treatment services may be a clinical prerequisite in the treatment
protocol for the care of individuals with diabetes.
We note that there does not appear to be a clear or singular
definitional framework for categorizing the state of diabetes, such as
``controlled'' or ``uncontrolled'' diabetes. Research submitted by the
public discusses improvements in glycemic control as evidence by HbA1c
markers, but does not delineate the characteristics of a patient that
would require direct clinical intervention (pharmacological,
behavioral, usage of DME such as insulin pumps, etc.) versus a patient
that would not require interventions given that their disease state is
not within a concerning range requiring direct medical treatment.
In the current literature, there are two types of severity measures
that can help categorizing the state of diabetes: the severity of
diabetes itself and the severity of periodontal disease among
individuals with diabetes. With respect to the severity of diabetes,
the American Diabetes Association recommends that most adults with
diabetes aim for a HbA1c level below 7.0% (<53 mmol/mol), along with
other recommended targets such as blood pressure below 130/80 mmHg and
LDL cholesterol below 100 mg/dL.\220\ In the current literature,
uncontrolled hyperglycemia is typically defined as a HbA1c level above
8.0% (>64 mmol/mol), according to guidelines from various medical
organizations including the ADA, American College of Physicians,
Association of Clinical Endocrinologists, and American College of
Endocrinology.221 222 223 224 Based on the literature, this
threshold serves as a ``take action'' point in managing diabetes and
has been used in previous studies to indicate poor glycemic control.
Achieving and maintaining target HbA1c levels is essential for
individuals with diabetes (as well as the general population) and is a
key goal of treatment. Moreover, we note that for the purposes of
Quality Payment Program (QPP) measures, CMS has issued measures for
diabetes (e.g. Quality ID #1 (NQF 0059): Diabetes: Hemoglobin A1c
(HbA1c) Poor Control (>9%)).\225\ The measure is described as
``Percentage of patients 18-75 years of age with diabetes who had
hemoglobin A1c > 9.0% during the measurement period.'' Furthermore,
measures of HbA1c may fluctuate over time; therefore, a strict
threshold could lead to incentives for multiple rounds of testing in
order to aim for the levels established. In general, guidelines exist,
but standards vary for defining diabetes states based on multiple
severity measures.
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\220\ American Diabetes Association. ``Standards of medical care
in diabetes--2011.'' Diabetes care vol. 34 Suppl 1, Suppl 1 (2011):
S11-61. doi:10.2337/dc11-S011.
\221\ Liu, Longjian et al. ``Burden of Uncontrolled
Hyperglycemia and Its Association with Patients Characteristics and
Socioeconomic Status in Philadelphia, USA.'' Health equity vol. 4,1
525-532. 30 Dec. 2020, doi:10.1089/heq.2020.0076.
\222\ Qaseem, Amir et al. ``Glycemic control and type 2 diabetes
mellitus: the optimal hemoglobin A1c targets. A guidance statement
from the American College of Physicians.'' Annals of internal
medicine vol. 147,6 (2007): 417-22. doi:10.7326/0003-4819-147-6-
200709180-00012.
\223\ Cortez-Espinosa, Nancy et al. ``Abnormal expression and
function of Dectin-1 receptor in type 2 diabetes mellitus patients
with poor glycemic control (HbA1c>8%).'' Metabolism: clinical and
experimental vol. 61,11 (2012): 1538-46. doi:10.1016/
j.metabol.2012.03.020.
\224\ Hu, Huanhuan et al. ``Hba1c, Blood Pressure, and Lipid
Control in People with Diabetes: Japan Epidemiology Collaboration on
Occupational Health Study.'' PloS one vol. 11,7 e0159071. 20 Jul.
2016, doi:10.1371/journal.pone.0159071.
\225\ https://qpp.cms.gov/docs/QPP_quality_measure_specifications/CQM-Measures/2023_Measure_001_MIPSCQM.pdf.
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In addition, the severity of periodontal disease is not uniformly
defined. ICD-10 codes, such as K05.2 for Aggressive Periodontitis and
K05.3 for Chronic Periodontitis may be utilized to describe more severe
instances of periodontitis (and in this instance when such diagnosis
codes are also partnered with diagnoses related to diabetes for a
particular individual). Another approach involves using the Armitage
criteria for periodontal diagnosis.226 227 Severity
assessment can be based on the clinical attachment level (CAL), with
CAL between 1 mm and 2 mm classified as slight, 3 mm and 4 mm as
moderate, and >=5 mm as severe.\228\ Again, some standards exist
relative to the staging of periodontitis, but such criteria vary.
Additionally, we believe that the current practice of medicine would
allow for variation in clinical attributes as well as judgment and
discernment by the referring practitioner regarding the clinical status
of the individual when determining the need for consultation with other
practitioner types, including the dentist. We seek comment on whether
clinical standards exist that describe and define the disease state of
diabetes that would serve to inform the selection of treatment
modalities, including potential referrals to dental professionals with
respect to concerns related to oral health. We also seek comment from
the public regarding the ways that CMS could ensure that practitioners
do not decrease the quality of diabetes treatment in an effort to
maintain a beneficiary's potential access to Medicare payment for
dental services.
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\226\ Armitage, G C. ``Development of a classification system
for periodontal diseases and conditions.'' Annals of periodontology
vol. 4,1 (1999): 1-6. doi:10.1902/annals.1999.4.1.1.
\227\ Caton, Jack G et al. ``A new classification scheme for
periodontal and peri-implant diseases and conditions--Introduction
and key changes from the 1999 classification.'' Journal of clinical
periodontology vol. 45 Suppl 20 (2018): S1-S8. doi:10.1111/
jcpe.12935.
\228\ Pinho, M Morado et al. ``Periodontitis and
atherosclerosis: an observational study.'' Journal of periodontal
research vol. 48,4 (2013): 452-7. doi:10.1111/jre.12026.
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Evidence supplied by submitters also described periodontitis but
without clear and consistent definitional structure. The 2017 World
Workshop on the Classification of Periodontal and Peri-Implant Diseases
and Conditions resulted in a new classification of periodontitis
characterized by a multidimensional staging and grading system. The
staging considers the aspects of severity, complexity, extent, and
distribution while the grading
[[Page 61760]]
contemplates primary criteria such as progression and grade modifiers,
including risk factors such as smoking and diabetes.\229\
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\229\ Tables from Tonetti, Greenwell, Kornman. J Periodontol
2018;89 (Suppl 1): S159-S172. https://www.perio.org/wp-content/uploads/2019/08/Staging-and-Grading-Periodontitis.pdf.
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For the purposes of our consideration of medical services for the
treatment of diabetes for individuals with diabetes who have
periodontitis, we seek comment from the public on clinical criteria
that would determine eligibility for effectiveness of periodontal
treatment as described in the Cochrane review and other studies. We do
not believe that a condition such as gingivitis or early stages of
periodontitis would require oral treatment that in turn would influence
the outcomes for an individual with diabetes. However, we seek
information to address the following questions. At what stages and
grading would the periodontitis be considered advanced and/or requiring
dental and oral treatment intervention? What types of practitioners are
able to make determinations regarding the staging of periodontitis? We
also seek comment on patient eligibility. What determines patient
eligibility for treatment for advanced periodontitis? Are there other
criteria for consideration?
Additionally, we seek comment on the duration of potential
periodontal treatment. How is the length of treatment determined? If a
patient's clinical status improves with respect to the periodontal
disease, what factors determine when periodontal treatment comes to an
end? What does maintenance treatment entail? What services are provided
in treatment of advanced periodontal disease? What is the service
definition? Are services bundled? If yes, what is included in the
bundle? When are the services provided and over what period? Is it
provided over a calendar month period? A single day? Multiple days? Are
services timed? Who provides the services? What specific terminology is
involved? Are these services ever provided under supervision? Or
``incident to'' by other clinical staff?
We also seek information on how services for advanced periodontal
disease are provided. Where and how are services for treatment of
advanced periodontal disease provided? Are there any special rules,
such as obtaining advance consent or performance of an initiating
visit?
We also seek information regarding coding and billing of
periodontal services. What coding is utilized for the treatment
services for advanced periodontal disease? What claims format is
employed for the submission of claims with related oral and dental
services (for example, 837D and/or 837P)?
Additionally, we seek comment from the public regarding the risk of
recurrence of periodontal disease for this patient population. What is
the level of risk for re-development of advanced periodontitis and
likelihood of recurrence?
We also seek information regarding the role of caries in management
of diabetes. What is the prevalence of caries in this patient
population? What is the impact of caries on management of diabetes?
We also seek information regarding the disease state of the
diabetes itself and its interaction with dental services. Does evidence
exist to support that certain characteristics related to diabetes
management (for example, maintenance of HbA1c) are more closely tied to
certain oral interventions' ability to yield clinical improvements?
We reiterate that 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. Thus,
payment is permitted only where the dental services are inextricably
linked to covered medical services. We believe that general maintenance
and management of oral disease processes clearly falls within the
statutory exclusion and therefore Medicare would not permit payment for
routine dental and oral services.
We note that many submitters stated that good dental and oral
health benefits a patient's overall health in general. Several
commenters responding to 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 (88 FR 79033).
In summary, we seek comment on whether certain dental services are
inextricably linked to certain other covered services for diabetes,
supported by clinical evidence as described in section II.J.1.c. of
this proposed rule. We also seek comment specifically on whether dental
services such as prophylaxis are a standard of care in the management
of diabetes. We are committed to continuing to explore the potential
inextricable relationship between dental services and covered medical
services utilized in treatment for individuals with diabetes. We thank
submitters for the information they provided through the public
submissions process and may consider revisions to the clinical examples
codified in our regulations at Sec. 411.15(i)(3)(i) based upon
additional data and information received in response to this proposed
rule.
4. Request for Comment on Dental Services Integral To Specific Covered
Services To Treat Systemic Autoimmune Disease Requiring
Immunosuppressive Therapies
We have received information from submitters suggesting that
certain dental services are inextricably linked to immunosuppressive
therapies for individuals with autoimmune disorders.
According to the NIH's National Institute of Environmental Health
Sciences, a healthy immune system is able to defend the body against
disease and infection. However, if the immune system malfunctions, it
may mistakenly attack healthy cells, tissues, and organs. This scenario
is called autoimmune disease, and these attacks can affect any part of
the body, weaken bodily function, and in some cases become life-
threatening.\230\ There are over 100 autoimmune diseases, including
Type 1 diabetes, multiple sclerosis, lupus, rheumatoid arthritis, and
inflammatory bowel disease. There are also other autoimmune diseases
that are rare and difficult to diagnose. In some cases, patients may
suffer for years before receiving a proper diagnosis, and most of these
diseases have no cure. Additionally, some autoimmune diseases require
lifelong treatment for system management.\231\
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\230\ https://www.niehs.nih.gov/health/topics/conditions/autoimmune.
\231\ Ibid.
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Autoimmune diseases are continuously affecting more people.
Estimates indicate that as many as 50 million people in the U.S. have
an autoimmune disease, making it the third
[[Page 61761]]
most prevalent disease category, surpassed only by cancer and cardiac
disease. Generally speaking, a person's genes in combination with
infections and other environmental exposures likely play a significant
role in disease development, though in some instances pathology may be
unknown. Additionally, nearly 80 percent of people with a chronic
autoimmune condition are women.\232\ Symptoms of autoimmune diseases
can include: fatigue, pain, dermatologic manifestations, weight loss or
gain, insomnia, fever, and myriad other symptoms.\233\
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\232\ Ibid.
\233\ https://www.womenshealth.gov/a-z-topics/autoimmune-diseases.
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Many treatment modalities are employed in the management of
autoimmune diseases. Treatments could include use of oral medications,
including steroids, anti-inflammatory medications, as well as infusion
immunotherapy. Some autoimmune conditions may present in a localized
fashion, such as Sjogren's, and many of the independent organ
inflammations, require immunosuppressive therapies, and may progress to
a more systemic involvement. Conversely, some systemic autoimmune
diseases, like sarcoidosis, may not require immunosuppression in mild
cases.
Submissions through the public submissions process urged us to
provide that payment can be made for dental services for individuals
with autoimmune diseases receiving immunosuppressive therapy. In
submissions, several interested parties have asserted that
immunosuppressive therapies utilized in the treatment of autoimmune
disease have similar immunosuppressive effects as those of toxic
chemotherapy utilized in the treatment of cancer and that these
treatments are analogous to the clinical examples finalized in CY 2024
PFS rulemaking for dental services inextricably linked to covered
medical services in the treatment of cancer.
Submitters stated that oral and dental treatment is also often
integral to the successful care and management of beneficiaries with
autoimmune diseases who are initiating or undergoing immunosuppressive
or immunomodulator therapy because the absence of medically necessary
oral and dental treatment can pose serious complications to those
beneficiaries and the covered medical services they receive. Submitters
state that, for example, dental infections can spread quickly when host
immunity is compromised by immunosuppressing or immunomodulating drugs
utilized in treatment. As such, submitters note that the American
College of Physicians has described that the implications of dental
disease in patients who are undergoing immunosuppressive therapy extend
beyond their oral disease, with potentially life-threatening
complications if the dental problems are not treated. For these
reasons, submitters state that the covered services upon which
immunocompromised patients depend (for example, immunosuppressive
therapy) should not proceed until a dental or oral exam is performed to
address the oral complications and/or clear the patient of an oral or
dental infection.
Submitters provided information regarding specific covered services
that they believe could be associated with treatments for
immunosuppressive therapy for the treatment of autoimmune disease and
that may increase infection risk, such as:
CPT codes 99212-99215: Evaluation and Management (E/M)
Services.
CPT codes 96365-96368: Infusion services.
Submitters also provided coding information related to drug
therapies, such as CPT codes for immunosuppressant drugs, including:
J0129: Abatacept (Orencia) for Rheumatoid Arthritis.
J0135: Adalimumad (Humira) for Crohn's, Ulcerative
Colitis, Rheumatoid Arthritis.