[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]
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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.
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SUMMARY: This major proposed rule addresses: changes to the physician
fee schedule (PFS); other changes to Medicare Part B payment policies
to ensure that payment systems are updated to reflect changes in
medical practice, relative value of services, and changes in the
statute; 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.
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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/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
[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.
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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
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.)
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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
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
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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-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.
---------------------------------------------------------------------------
\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.
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\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.
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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/index.html.
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
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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.
BILLING CODE P
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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/index.html).
3. Methodology for the Direct PE Inputs To Develop PE RVUs
a. Background
On an annual basis, the RUC provides us with recommendations
regarding PE inputs for new, revised, and potentially misvalued codes.
We review the RUC-recommended direct PE inputs on a code-by-code basis.
Like our review of recommended work RVUs, our review of recommended
direct PE inputs generally includes, but is not limited to, a review of
information provided by the RUC, HCPAC, and other public commenters,
medical literature, and
[[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\
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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-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.
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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.
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\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.
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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.
---------------------------------------------------------------------------
\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
[[Page 61669]]
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,
[[Page 61670]]
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. http://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. http://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. http://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. http://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. http://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. http://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. http://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 http://
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/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.
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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\
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\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.
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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/index.html.)
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
\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.
J0490: Belimumab (Benlysta) for systemic lupus
erythematosus (SLE), Lupus Nephritis, and Sj[ouml]gren's.
J0491: Anifrolumab-fnia (Saphnelo) for systemic lupus
erythematosus (SLE).