[Federal Register Volume 89, Number 236 (Monday, December 9, 2024)]
[Rules and Regulations]
[Pages 97710-99057]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-25382]
[[Page 97709]]
Vol. 89
Monday,
No. 236
December 9, 2024
Part II
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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42 CFR Parts 401, 405, 410, 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;
Final Rule
Federal Register / Vol. 89 , No. 236 / Monday, December 9, 2024 /
Rules and Regulations
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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-F and CMS-4201-F5]
RIN 0938-AV33 and 0938-AU96
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: Final rule.
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SUMMARY: This final 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 establishment of new 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 and
Medicare Parts C and D Overpayment Provisions of the Affordable Care
Act.
DATES: These regulations are effective on January 1, 2025.
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.
Hannah Ahn, (814) 769-0143, or
[email protected], for issues related to
potentially misvalued services under the PFS.
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-on.
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.
Michelle Cruse, (443) 478-6390, Erick Carrera, (410) 786-8949,
Zehra Hussain, (214) 767-4463, or
[email protected], for issues related to dental
services inextricably linked to other 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.
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.
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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.
Alissa Stoneking, (410)786-1120, for issues related to Parts C and
D 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, 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 final 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 final rule, refer to item CMS-1807-F. Readers with questions
related to accessing any of the Addenda or other supporting documents
referenced in this final rule and posted on the CMS website identified
above should contact [email protected].
CPT (Current Procedural Terminology) Copyright Notice: Throughout
this final 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 final rule revises payment policies under the Medicare PFS and
makes other policy changes, including the implementation of 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 final
rule includes provisions regarding other Medicare payment policies
described in sections III. and IV.
This rulemaking also codifies 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 Social
Security Act (the Act). This rulemaking establishes 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, 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 updates 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. These changes also aim to ensure RHCs are provided
flexibility in the services they offer, including specialty and
laboratory services.
This rulemaking also further advances 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 these 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 amends our regulations regarding the standard for
an ``identified overpayment'' under Medicare Parts A, B, C, and D to
align the regulations with the statutory language in section
1128J(d)(4)(A) of the Act, which provides that the terms ``knowing''
and ``knowingly'' have the meaning given to those terms in the Federal
False Claims Act. 87 FR 79559. This rulemaking also finalizes proposals
regarding timeframes for reporting and returning Parts A and B
overpayments that we made in the CY 2025 PFS proposed rule.
B. Summary of the Key Provisions
Section 1848 of 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
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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 final rule, we 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 final 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 final 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.)
Provisions on Medicare Parts A and B Payment for Dental
Services Inextricably Linked to Other Covered Services (section II.J.)
Payment for Skin Substitutes (section II.K.)
Strategies for Improving Global Surgery Payment Accuracy
(section II.L.)
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.)
Modifications to Coverage of 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.)
Medicare Parts C and D Overpayment Provisions of the
Affordable Care Act (section III.P.)
Updates to the Quality Payment Program (section IV.)
Collection of Information Requirements (section V.)
Regulatory Impact Analysis (section VI.)
C. Summary of Costs and Benefits
We have determined that this final rule is economically
significant. We estimate the CY 2025 PFS conversion factor to be
32.3465 which reflects a 0.02 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 VI., Regulatory Impact
Analysis, of this final rule.
II. Provisions of the Final 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 final 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 referred 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
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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
referred 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 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 final rule PE/HR'' on the
CMS website under downloads for the CY 2025 PFS final 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 proposed 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 final rule PE/HR''
file available on the CMS website under the supporting data files for
the CY 2025 PFS final rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
Comment: One commenter stated that they supported the proposal to
include utilization data for MFTs and MHCs in calculating practice
expense Relative Value Units. The commenter stated that accurate RVUs
ensure that MFTs and MHCs receive appropriate reimbursement, covering
essential overhead costs and sustaining their practices, which supports
the financial viability of mental health practices and also promotes
equitable access to care for all patients, regardless of the complexity
of their conditions.
Response: We appreciate the support for our proposal from the
commenter.
After consideration of the comments, we are finalizing our proposed
PE/HR crosswalks for the Marriage and Family Therapist and Mental
Health Counselor specialties.
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
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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 final
rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. This file
contains a table that illustrates the calculation of PE RVUs as
described in this proposed rule for individual codes.
(a) Setup File
First, we create a setup file for the PE methodology. The setup
file contains the direct cost inputs, the utilization for each
procedure code at the specialty and facility/nonfacility place of
service level, and the specialty specific PE/HR data calculated from
the surveys.
(b) Calculate the Direct Cost PE RVUs
Sum the costs of each direct input.
Step 1: Sum the direct costs of the inputs for each service.
Step 2: Calculate the aggregate pool of direct PE costs for the
current year. We set the aggregate pool of PE costs equal to the
product of the ratio of the current aggregate PE RVUs to current
aggregate work RVUs and the projected aggregate work RVUs.
Step 3: Calculate the aggregate pool of direct PE costs for use in
ratesetting. This is the product of the aggregate direct costs for all
services from Step 1 and the utilization data for that service.
Step 4: Using the results of Step 2 and Step 3, use the CF to
calculate a direct PE scaling adjustment to ensure that the aggregate
pool of direct PE costs calculated in Step 3 does not vary from the
aggregate pool of direct PE costs for the current year. Apply the
scaling adjustment to the direct costs for each service (as calculated
in Step 1).
Step 5: Convert the results of Step 4 to an RVU scale for each
service. To do this, divide the results of Step 4 by the CF. Note that
the actual value of the CF used in this calculation does not influence
the final direct cost PE RVUs as long as the same CF is used in Step 4
and Step 5. Different CFs would result in different direct PE scaling
adjustments, but this has no effect on the final direct cost PE RVUs
since changes in the CFs and 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
[[Page 97715]]
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.
We did not make any proposals associated with the list of expected
specialty assignments for low volume services, however we received
public comments on this topic from interested parties. The following is
a summary of the comments we received and our responses.
Comment: Several commenters stated that they had performed an
analysis to identify all codes that meet the criteria to receive a
specialty override under this CMS policy and drafted updated
recommendations for codes that meet these criteria for CY 2024.
Commenters stated that the purpose of assigning a specialty to these
codes was to avoid the significant adverse impact on MP RVUs that
results from errors in specialty utilization data magnified in
representation (percentage) by small sample size. These commenters
submitted a list of approximately 75 low volume HCPCS codes with
recommended expected specialty assignments.
Response: After reviewing the information provided by the
commenters to determine whether the specialty assignments they
recommended were appropriate for the services in question, based on
determining if the recommended specialty matches the dominant specialty
in the claims data, we are finalizing the additions to the list of
expected specialty assignments for low volume services identified in
Table 1. We agreed with the commenters that, based on claims data, CPT
codes 33231 and 33240 should be crosswalked to the Cardiac
Electrophysiology specialty and that CPT codes 33900-33904 and 93574-
93575 should be crosswalked to the Interventional Cardiology specialty.
We also agree with commenters that CPT codes 56633 and 58240 should be
crosswalked to the Gynecological Oncology specialty. However, we do not
have PE/HR data for these specialties as they were not part of the PPIS
when it was conducted in 2007; therefore, we are crosswalking these CPT
codes to the closest available specialties (Cardiology and Obstetrics/
Gynecology, respectively), as listed on Table 1.
We disagreed with the commenters on a series of additional
suggested assigned specialties. In each case, there was another
specialty which was reported more than twice as often in the claims
data as the specialty suggested by commenters and in some cases
reported as much as twenty times as often. Therefore, we are
crosswalking CPT code 22505 to the Neurosurgery specialty, CPT code
25670 to the Orthopedic Surgery specialty, CPT code 28116 to the
Podiatry specialty, CPT code 35231 to the Otolaryngology specialty, CPT
code 36585 to the General Surgery specialty, CPT code 36810 to the
Pulmonary Disease specialty, and CPT code 60522 to the Thoracic Surgery
specialty (which was additionally suggested by one commenter) as these
were the dominant specialties in the claims data. These crosswalks are
included in Table 1.
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After consideration of the public comments, we are finalizing the
additions to the list of expected specialty assignments for low volume
services as detailed in Table 1. The full list of expected specialty
assignments is included in the CY 2025 public use files, which are
available on the CMS website under downloads for the CY 2025 PFS final
rule at http://www.cms.gov/Medicare/Medicare-Fee-for-ServicePayment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
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
[[Page 97718]]
adding the product of the adjusted indirect PE allocator for each
service and the utilization data for that service.
Step 13: Using the specialty specific indirect PE/HR data,
calculate specialty specific aggregate pools of indirect PE for all PFS
services for that specialty by adding the product of the indirect PE/HR
for the specialty, the work time for the service, and the specialty's
utilization for the service across all services furnished by the
specialty.
Step 14: Using the results of Step 12 and Step 13, calculate the
specialty specific indirect PE scaling factors.
Step 15: Using the results of Step 14, calculate an indirect
practice cost index at the specialty level by dividing each specialty
specific indirect scaling factor by the average indirect scaling factor
for the entire PFS.
Step 16: Calculate the indirect practice cost index at the service
level to ensure the capture of all indirect costs. Calculate a weighted
average of the practice cost index values for the specialties that
furnish the service. (Note: For services with TCs and PCs, we calculate
the indirect practice cost index across the global service, PCs, and
TCs. Under this method, the indirect practice cost index for a given
service (for example, echocardiogram) does not vary by the PC, TC, and
global service.)
Step 17: Apply the service level indirect practice cost index
calculated in Step 16 to the service level adjusted indirect allocators
calculated in Step 11 to get the indirect PE RVUs.
(d) Calculate the Final PE RVUs
Step 18: Add the direct PE RVUs from Step 5 to the indirect PE RVUs
from Step 17 and apply the final PE budget neutrality (BN) adjustment.
The final PE BN adjustment is calculated by comparing the sum of steps
5 and 17 to the aggregate work RVUs scaled by the ratio of current
aggregate PE and work RVUs. This adjustment ensures that all PE RVUs in
the PFS account for the fact that certain specialties are excluded from
the calculation of PE RVUs but included in maintaining overall PFS BN.
(See ``Specialties excluded from ratesetting calculation'' later in
this final 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 referred 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 2.
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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,
[[Page 97720]]
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 3 details the manner in which the modifiers are
applied.
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We also adjust volume and time that correspond to other payment
rules, including special multiple procedure endoscopy rules and
multiple procedure payment reductions (MPPRs). We noted 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 proposed 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.L. of this final 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
final 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.
[[Page 97721]]
price = price of the particular piece of equipment.
life of equipment = useful life of the particular piece of
equipment.
maintenance = factor for maintenance; 0.05.
interest rate = variable, see discussion below in this proposed
rule.
Usage: We currently use an equipment utilization rate assumption of
50 percent for most equipment, with the exception of expensive
diagnostic imaging equipment, for which we use a 90 percent assumption
as required by section 1848(b)(4)(C) of the Act.
Useful Life: In the CY 2005 PFS final rule we stated that we
updated the useful life for equipment items primarily based on the
AHA's ``Estimated Useful Lives of Depreciable Hospital Assets''
guidelines (69 FR 66246). The most recent edition of these guidelines
was published in 2018. This reference material provides an estimated
useful life for hundreds of different 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 4.
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We did not propose 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 2017-based 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,
[[Page 97722]]
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 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 2017-based 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 2017-based 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 2017-based 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 2017-based 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 2017-based 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 the CY 2025 PFS proposed rule, we stated that 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 stated that 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. We stated
that 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 did
not propose to incorporate the 2017-based MEI in PFS ratesetting for CY
2025. We invited 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. The
following is a summary of the comments we received and our responses.
Comment: Many commenters supported our continued delayed
implementation of the 2017-based MEI in PFS ratesetting. Most of these
commenters urged CMS to delay consideration of other sources for the
MEI until the AMA's efforts to collect practice cost data from
physician practices have concluded. The AMA RUC commented that they
concluded survey efforts on August 31, 2024, and are working to analyze
the data. Some commenters requested a more frequent update of the PPIS
every three to five years given the dramatic redistributive impacts of
implementing updated data after many years. Some commenters requested a
separate MEI for behavioral health to adequately and appropriately
value outpatient mental health and substance use services. Another
commenter disagreed with more frequent PPIS efforts because they can be
burdensome, particularly for small, independent practices in
underserved areas where time must be taken away from direct patient
care to complete the survey. The commenter stated that larger health
systems and practices are more equipped to respond to these surveys
which leads to biased and unreliable survey results. The commenter
urged CMS to consider contingencies or alternatives to the PPIS to
address the lack of data availability or response rates for some
specialties. One commenter requested that CMS seek alternative, more
current data sources to rebase and revise the MEI if the AMA PPIS data
proves insufficient, stating that the 2017-based MEI derived
predominantly from the 2017 US Census Bureau's Service Annual Survey
(SAS) are outdated and should not be used for updates.
A few commenters urged CMS to implement the 2017-based MEI for PFS
ratesetting as soon as possible. One commenter stated that the SAS
Census Bureau data should be used to determine the MEI in the future
instead of the AMA's PPIS data because it is reliable, regularly
updated, and objectively collected.
Response: We appreciate commenters' feedback, specifically as it
relates to updating PFS ratesetting, and will consider the commenters'
feedback in future rulemaking.
Comment: One commenter stated that CMS finalized the 2017-based MEI
based primarily on a subset of data from the 2017 US Census Bureau's
SAS. The commenter stated that assumptions made for the updated weights
did not include physicians who are employed by hospitals and large
health systems. The commenter stated that data from facility-based
physicians should be included since MEI weights also cover physician
compensation and professional liability insurance.
Response: We refer the commenter to the discussion of methodologies
and a response to this concern in the CY 2024 PFS final rule (88 FR
78830 and 78831).
4. Changes to Direct PE Inputs for Specific Services
This section focuses on specific PE inputs. The direct PE inputs
are
[[Page 97723]]
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 final
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 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 directed 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 directed 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
[[Page 97724]]
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 final 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 referred readers to the CY 2019 PFS
final rule with comment period (83 FR 59473 through 59480).
For CY 2025, we proposed 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 20, CY
2025 Invoices Received for Existing Direct PE Inputs.
Comment: Several commenters stated that they commended CMS for
recognizing the importance and cost of Long-Term Electrocardiography
Monitoring (LT-ECG) Services, reflected in the updated pricing for
supply item SD339. The commenters stated that the updated pricing is
critical for ensuring patient access to LT-ECG services under CPT codes
93241, 93243, 93245, and 93247, while also providing essential payment
stability for providers.
Response: We appreciate the support from the commenters for our
proposed SD339 supply pricing.
Comment: A commenter stated that they supported the proposed
pricing increases for the EP112 equipment and the SL474, SL478, SL479,
SL480, SL482, and SL492 supplies. The commenter stated that they
supported the proposed changes to the pricing for these items and urges
CMS to finalize them as proposed. A separate commenter stated that they
supported the proposed change to the pricing of the SL474 supply as
they believe it improves the accuracy of pricing for practice expense
items within the overall fee schedule.
Response: We appreciate the support from the commenters for our
proposed supply and equipment pricing.
Comment: A commenter stated that they fully supported CMS's
proposal to create three new supply codes in the PE database (SD370,
SD371, and SD372) to facilitate appropriate pricing by the MACs for
Temporary Female Intraurethral Valve-Pump services. The commenter
stated that they agreed that short of establishing national pricing for
CPT codes 0596T and 0597T, creating supply codes with accurate pricing
for the devices should facilitate rate setting by the MACs that
appropriately accounts for the device costs. The commenter urged CMS to
finalize as proposed the creation of these supply codes and the
proposed prices that correspond to each.
Response: We appreciate the support from the commenter for our
proposed supply pricing of the SD370-SD372 items.
An interested party submitted 30 invoices to update pricing for the
human amniotic membrane allograft 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
proposed for the SD248 supply. We solicited 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.
Comment: Many commenters stated that they supported the proposed
payment increase for CPT 65778 based on the proposed pricing of the
SD248 supply. Commenters described the clinical benefits of the SD248
supply and how it has been instrumental in helping patients with
medical conditions that would not respond to conventional medical
treatment.
Response: We appreciate the support from the commenters for our
proposed pricing of the SD248 supply.
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 proposed the
updated total average price of $125.11 based on the eight submitted
invoices for the SL083 supply, however, we solicited 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.
Comment: Several commenters thanked CMS for updating the price of
the indocyanine green (25ml uou) (SL083) supply in the proposed rule
and recommended that this price be finalized. Commenters stated that
the differences in pricing for the SL084 supply contained on the
submitted invoices demonstrated an increase that occurred during the
second half of 2023 rather than a price differential between two
distinct products; commenters stated that practices paid an average of
[[Page 97725]]
$87 earlier in 2023 and by 2024 the price had increased to $141, with
some paying as much as $156.
Response: We appreciate the support from the commenters for our
proposed supply pricing of the SL083 supply, as well as the additional
information regarding its pricing.
Regarding the Reaction buffer 10X (Ventana 950-300) (SL478) supply,
we proposed 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 proposed
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 proposed
to make this correction for CY 2025; the corrected price of $2.66 for
the SL464 supply is included in Table 20.
Comment: A commenter stated that the proposed payment rates for
HCPCS codes G2082 and G2083 did not include the updated supply pricing
for esketamine described by the SH109 and SH110 supply codes, based on
wholesale acquisition cost (WAC) data submitted by the commenter to CMS
on May 31, 2024. The commenter stated that lack of consistent WAC
supply pricing updates has contributed to payment instability for these
services and puts beneficiary access at risk. The commenter stated that
their goal was to align on a clear process to ensure consistency and
predictability in the approach to updating the annual payment amounts
for the SH109 and SH110 supplies and urged CMS to incorporate the
updated WAC pricing data for these supplies in the PFS final rule.
Response: We did not propose to update the price of the SH109 and
SH110 esketamine supplies in the proposed rule. However, as part of our
process to act on public requests to update equipment and supply
prices, we have reviewed the WAC pricing data submitted by the
commenters. Based on this information, we are finalizing an increase in
the pricing of the SH109 supply from $735.63 to $772.41 and an increase
in the pricing of the SH110 supply from $1103.44 to $1158.62.
With regards to the process for submitting annual pricing updates
for these supply items, we remind the commenter that 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 will 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].
We did not propose 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
solicited 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 did not propose updates to
the prices for these supplies. We solicited 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 5 years since we most recently updated the pricing for
these supplies.
Comment: A commenter stated that they continue to believe that CPT
code 36516 suffers from a large reimbursement gap between the facility
and non-facility/physician office setting because CMS is using outdated
pricing data for essential liposorber supplies. The commenter therefore
submitted additional paid invoices for three liposorber supply items:
the tubing set (SC083), Plasma LDL adsorption column (SD186), and
plasma separator (SD188). The commenter stated that these invoices
clearly identified the unit quantity and provided a breakdown of the
costs to show the individual (per-supply item price) as well as case
price (6 items per case per different supply item).
Response: We appreciate the additional invoice submissions from the
commenter and the clarification on the supply quantities for the
associated supply items. Based on this additional pricing data, we are
finalizing price increases to $87.52 for the SC083 supply, to $1419.04
to the SD186 supply, and to $149.70 for the SD188 supply, in each case
based on an average of the six submitted invoices.
Comment: A commenter stated that Liposorber supplies are unique in
that they require special shipping, handling, storing, and insurance
requirements. The commenter stated that, for instance, the Plasma LDL
adsorption Column (SD186) and the Plasma Separator (SD188) are
sensitive to atmospheric conditions and must be packaged, shipped, and
stored at mandated temperatures, as well as avoid exposure to cold,
direct sunlight, high humidity, or excessive vibrations. The commenter
stated that the high cost and fragility of these supplies requires the
practice to purchase additional insurance coverage, and these
additional shipping and handling costs are not reflected in the
invoiced purchase price but add considerable expense to the provision
of apheresis services.
Response: We remind the commenter that shipping and storage costs
are not included in the price of supplies and equipment under our PE
methodology. This is because these costs are covered under the indirect
portion of the PE; it is not the case that these costs are not being
paid, but rather that they are addressed under a different part of the
PE methodology.
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 did not
propose 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
[[Page 97726]]
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 did not propose 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 did not propose
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 did not propose 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 did not propose 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 did not propose increases to
the prices for these supplies.
(1) Invoice Submission
We reminded readers that we routinely accept public submissions of
invoices as part of our process for developing payment rates for new,
revised, and potentially misvalued codes. Often, these invoices are
submitted in conjunction with the RUC-recommended values for the codes.
To be included in a given year's proposed rule, we generally need to
receive invoices by the same February 10th deadline we noted for
consideration of RUC recommendations. However, we will consider
invoices submitted as public comments during the comment period
following the publication of the PFS proposed rule and will 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 welcomed 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.
Comment: Many commenters supported the concept of more regular and
comprehensive updates to supply and equipment pricing. Commenters
stated their support for a deliberate, systematic approach to supply,
equipment, and clinical labor updates and agreed that it would be
prudent to update pricing consistently, such as every 5 years. Many
commenters stated that such a process would provide transparency in the
timing of these updates, give greater granularity into the data sources
that serve as the basis of input pricing changes, and maintain the
current process that allows stakeholders to submit invoices in advance
of rulemaking. Several commenters requested the implementation of a 4-
year phase-in transition for any future pricing updates, as gradually
phasing in cost changes helps to prevent abrupt and potentially harmful
effects on specific providers or services. One commenter stated that
establishing a cycle of updates every four years was not advisable, as
updates that frequent could amplify the impact of short-term market
fluctuations, in addition to increasing the administrative burden for
both CMS and health care providers.
Response: We appreciate the feedback from the commenters regarding
potential future updates to supply and equipment pricing, which we will
consider for use in potential 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.
[[Page 97727]]
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 proposed to implement the supply pack pricing
update and associated revisions as recommended by the RUC's workgroup.
We proposed 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 also proposed to delete the
``pack, drapes, laparotomy (chest-abdomen)'' (SA046) supply entirely.
The updated prices for these supply packs are listed in the valuation
of specific codes section of the preamble under Table 20, CY 2025
Invoices Received for Existing Direct PE Inputs.
In accordance with the RUC workgroup's recommendations, we also
proposed to create 8 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
proposed 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% (eg, 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 new supply pack component items are listed in the valuation of
specific codes section of the preamble under Table 21, CY 2025 New
Invoices.
We also proposed the following additional supply substitutions
based on the recommendations of the RUC workgroup. We proposed to
remove the deleted SA046 supply pack and replace it with the drape,
sterile, fenestrated 16 in x 29 in (SB011) supply for CPT codes 19020,
19101, 19110, 19112, 20101, and 20102. We proposed 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 18
in x 26 in (SB019)--for CPT codes 19000 and 60300. We proposed to
remove the deleted SA046 supply pack and replace it with 2 supplies--
the drape, towel, sterile 18 in x 26 in (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
proposed to remove the deleted SA046 supply pack without replacing it
with anything for CPT code 22526; the RUC workgroup did not make a
recommendation on what to do with CPT code 27278, which also previously
contained the SA046 supply pack. Therefore, we also proposed 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.
Comment: Several commenters stated their appreciation that CMS
proposed to implement the supply pack pricing update and associated
revisions as recommended by the RUC's workgroup.
Response: We appreciate the support for our proposal from the
commenters.
Comment: Several commenters supported the proposed supply pack
pricing update as recommended by the RUC workgroup, however they
indicated concern over the proposed decrease in the price of the
urology cystoscopy visit pack (SA058) from $113.70 to $37.63.
Commenters stated that the proposed pricing reduction in the SA058
supply could result in drastic payment rate cuts for physicians
performing cystoscopy services in the office setting. Commenters
requested that CMS either delay the pricing update or phase-in the
supply pack changes over a four-year period like it has done for other
PE changes with significant redistributive effects, allowing
independent urology practices to better prepare for the negative
financial impact this change will have. One commenter requested that
pricing reductions should be implemented over a 7- to 10-year period.
Response: We appreciate the feedback from the commenters regarding
the proposed changes in pricing for these supply packs, particularly
the decrease in pricing for the urology cystoscopy visit pack (SA058).
After considering the comments, we agree that the use of a phased-in
transition period would be appropriate to allow practitioners to adjust
to the updated pricing of these supplies. During our previous supply
and equipment pricing update in the CY 2019 PFS final rule, we
finalized a policy to phase in any updated pricing that we established
during the 4-year transition period for very commonly used supplies and
equipment, such as sterile gloves (SB024) or exam tables (EF023), even
if invoices were provided as part of the formal review of a code family
(83 FR 59475). Based on this previously established policy, we are
finalizing the use of a pricing transition for three supply packs:
[[Page 97728]]
[GRAPHIC] [TIFF OMITTED] TR09DE24.005
Following the same pattern as our previous supply/equipment and
clinical labor pricing updates, we are finalizing 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 2025, one-third of the difference between the CY
2025 price and the final price is implemented for CY 2026, and one-half
of the difference between the CY 2026 price and the final price is
implemented for CY 2027, with the new direct PE prices fully
implemented for CY 2028 (86 FR 65025). For the other proposed supply
packs, the cystoscopy drapes pack (SA045) is only included in 7 HCPCS
codes and the ocular photodynamic therapy pack (SA049) is only included
in a single HCPCS code which do not meet these criteria established in
previous rulemaking. We are therefore finalizing each of them at their
updated pricing for CY 2025 as proposed in the proposed rule. We
believe that the use of this pricing transition will minimize any
potential disruptive effects during the 4-year transition period that
could be caused by other sudden shifts in RVUs due to the high number
of services that make use of these very common supply packs.
Comment: Several commenters stated that although five incomplete
packs would have their pricing updated in the proposed rule,
mathematical errors still remained for a number of additional supply
packs. Commenters stated that only 3 of the 18 affirmed packs were
priced correctly to match their components and provided tables showing
the pricing of an additional 15 packs that needed mathematical
correction by deconstructing the packs to determine the correct price
through summing their individual components. Commenters requested that
CMS initiate a correction of the packs pricing such that the sum of the
individual components match the price of the corresponding pack.
Response: We appreciate the additional information provided by the
commenters regarding the pricing of these supply packs. We have
compiled this information provided by the commenters for the 15
affected supply packs into Table 6.
[GRAPHIC] [TIFF OMITTED] TR09DE24.006
[[Page 97729]]
While we share the concerns of the commenters regarding the need
for accuracy in the pricing of these supply packs, we have reservations
about their potential for pricing disruptions. Ten of these supply
packs are included in the direct PE inputs for at least 100 HCPCS
codes, and three of the packs are included in more than 1000 HCPCS
codes. Many of these pricing updates would lead to drastic changes in
pricing for these supply packs which are included in hundreds of HCPCS
codes, such as the SA051 pelvic exam pack decreasing in price from
$20.16 to $2.81 (-86 percent) and the SA048 minimum multi-specialty
visit pack decreasing in price from $5.02 to $1.98 (-61 percent). We
are particularly concerned that these changes in supply pack pricing
could lead to significant shifts in the overall PE RVU for affected
HCPCS codes, without these proposed rates appearing in the proposed
rule or allowing any opportunity for public comment.
Therefore, we are not finalizing pricing updates for these
additional 15 supply packs as requested by commenters. We anticipate
returning to this subject in future rulemaking to allow any changes in
associated pricing for HCPCS codes to appear in the proposed rule and
provide an opportunity for the public to comment. Should these supply
pack pricing updates be proposed in future rulemaking, we anticipate
that we may propose the same pricing transition described above due to
the number of potentially affected HCPCS codes. We are finalizing all
of the other supply pack pricing changes as proposed, with the
exception of the 4-year pricing transition for three supply packs as
described above.
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 appreciated the recommendations from the RUC workgroup and
concur that generic alternatives should be used in place of brand
names, where appropriate, in the CMS direct PE database. However, we
had no pricing information or submitted invoices for the 4 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
4 potential new supplies had no pricing information and are not
currently included as direct PE inputs for any HCPCS codes, we did not
add them to our direct PE database for the CY 2025 proposed rule due to
lack of available information.
Comment: Several commenters, including the RUC, stated that they
solicited invoices for Dermabond and its generic alternatives. The
commenters stated that they were able to find and submit invoices for
the Dermabond (SG007) supply but were unable to find invoices for the
generic skin adhesives. Commenters stated that they continued to
believe that generic versions overall are a better alternative than the
use of brand names in the CMS direct PE database and encouraged CMS to
explore other sources of information regarding generic skin adhesives.
Response: We appreciate the feedback from commenters regarding
these skin adhesives and the submission of invoices associated with the
SG007 supply. We agree with the commenters that the use of generic
alternatives is preferred in place of brand names when naming new
supply and equipment items for use in the CMS direct PE database.
However, many of the supply and equipment items such as the SG007
supply have existed in the CMS files for decades at this point. We
believe that it would be more disruptive and potentially confusing to
attempt to rename items like the SG007 supply given how the current
Dermabond name has been in common use for PFS ratesetting for at least
20 years. We are not finalizing a change to the name of this supply,
and since we received no pricing information or submitted invoices for
the four generic formulations of cyanoacrylate skin adhesive, we are
not finalizing any changes to their status as well.
With regards to the submitted invoices for the SG007 supply, the
six invoices refer to different Dermabond products and their unit
quantity size is unclear. The current SG007 supply simply has the unit
size of ``item'' and we were unable to determine how the submitted
invoices relate in terms of pricing to the current supply. We are
therefore not finalizing an update to the price of the SG007 supply at
this time.
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
[[Page 97730]]
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 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 4 years to
transition from current prices to the final updated prices in CY 2025.
We finalized the implementation of this pricing transition over 4
years, such that one-quarter of the difference between the current
price and the fully phased-in price is implemented for CY 2022, one-
third of the difference between the CY 2022 price and the final price
is implemented for CY 2023, and one-half of the difference between the
CY 2023 price and the final price is implemented for CY 2024, with the
new direct PE prices fully implemented for CY 2025. (86 FR 65025) An
example of the transition from the current to the fully-implemented new
pricing that we finalized in the CY 2022 PFS final rule is provided in
Table 7.
[GRAPHIC] [TIFF OMITTED] TR09DE24.007
[[Page 97731]]
(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 8 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:
[[Page 97732]]
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[[Page 97733]]
[GRAPHIC] [TIFF OMITTED] TR09DE24.009
As was the case for the market-based supply and equipment pricing
update, the clinical labor rates remained open for public comment
during the 60-day comment period for the CY 2025 PFS proposed rule. We
stated that we expect to set the updated clinical labor rates for CY
2025 in this 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 directed readers to the CY 2022 PFS
final rule (86 FR 65020 through 65037).
Comment: Several commenters urged CMS to freeze the final year of
implementation of the clinical labor policy in CY 2025 to avoid further
redistributions and instability in the PFS. Commenters asked CMS to
hold harmless the specialties that were most affected by the clinical
labor pricing update and not move forward with the final year of the
phase-in. One commenter disagreed with the finalized BLS 2021 benefit
multiplier of 1.296 and stated that CMS should use the originally
proposed 1.366 benefits multiplier instead.
Response: We finalized the use of a 4-year transition in the CY
2022 PFS final rule to help smooth out the changes in payment resulting
from the clinical labor pricing update, avoiding potentially disruptive
changes in payment for affected stakeholders, and promoting payment
stability from year-to-year. As we stated in the CY 2022 PFS final
rule, under section 1848 of the Act, we are required to base payment
for services under the PFS on relative resource costs. To accomplish
that, it is necessary periodically to update the information on which
we base relative values. We believe, and commenters overwhelmingly
agreed, that the BLS wage data is the best source to use for clinical
labor pricing, and commenters did not identify alternative sources of
data that could be used to update pricing. Although we recognize that
payment for some services will be reduced as a result of the pricing
update due to the BN requirements of the PFS, we do not believe that
this is a reason to refrain from updating clinical labor pricing to
reflect changes in resource costs over time as suggested by some
commenters. The PFS is a resource-based relative value payment system
that necessarily relies on accuracy in the pricing of resource inputs;
continuing to use clinical labor cost data that are nearly two decades
old would maintain distortions in relativity that undervalue many
services which involve a higher proportion of clinical labor. As noted
above, we also finalized the implementation of the pricing update
through a 4-year transition to help address the concerns of the
commenters about stabilizing RVUs and reducing large fluctuations in
year-to-year payments. We direct readers to this prior discussion in
the CY 2022 PFS final rule at 86 FR 65025.
Comment: Several commenters stated that the ongoing clinical labor
pricing update was having the effect of driving patient care from the
non-facility to the facility setting. The commenters stated that access
to care for beneficiaries is increasingly constrained for many
essential services and listed a series of procedures most impacted,
such as hemorrhagic and ischemic strokes, maternal health, PAD,
dialysis access, limb salvage services, and CPT code 93229 (External
mobile cardiovascular telemetry with electrocardiographic recording,
concurrent computerized real time data analysis and greater than 24
hours of accessible ECG data storage (retrievable with query) with ECG
triggered and patient selected events transmitted to a remote attended
surveillance center for up to 30 days; technical support for connection
and patient instructions for use, attended surveillance, analysis and
transmission of daily and emergent data reports as prescribed by a
physician or other qualified health care professional).
Response: We previously addressed these concerns about site of
service and patient access to care when we finalized the clinical labor
pricing update; we direct readers to this prior discussion in the CY
2022 PFS final rule at 86 FR 65025.
Comment: A commenter stated that, to promote predictability and
stability in physician payments and mitigate the financial impacts of
significant fluctuations in physician payments that might accompany the
clinical labor pricing update, CMS should consider using a threshold to
limit the level of reductions in payments for specific services that
would occur in a single year. The commenter stated that CMS consider
implementing a cap on payment cuts to individual codes in a single
year.
Response: We agree with the commenter on the importance of avoiding
potentially disruptive changes in payment for affected interested
parties and the need to promote payment stability from year-to-year.
This is why we finalized the use of a multi-year transition for the
clinical labor update in the CY 2022 PFS final rule to help smooth out
the changes in payment resulting from the updated data (86 FR 65024).
We also note for the commenter that section 1848(c)(7) of the Act, as
added by section 220(e) of the PAMA, 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. For additional information regarding the phase-in of
significant RVU reductions, we direct readers to the CY 2016 PFS final
rule with comment period (80 FR 70927 through 70929).
Comment: A commenter thanked CMS for raising the clinical labor
rate paid to nurses, however the commenter stated that this was only
one step and nurses are consistently undervalued across all settings.
The commenter stated that nursing care should be valued more highly
than it is today and that nursing care is still undervalued in today's
healthcare system. The commenter stated that RNs are mentioned in ten
separate rows on the clinical labor pricing table, with the rate per
minute for nurses varying from $0.52 per minute to $0.81 per minute,
which brings uncertainty to the fee schedule as the value of the nurse
fluctuates depending on the situation.
Response: We note for the commenter that the proposed CY 2025
clinical labor rate for the RN (L051A) type is $0.76,
[[Page 97734]]
which is based upon Bureau of Labor Statistics wage data as outlined in
our methodology above. We believe that the BLS wage data continues to
be the most accurate source to use as a basis for clinical labor
pricing, and we did not receive any alternate wage data from commenters
to suggest alternate RN pricing. With regards to the multiple listing
of RNs on the table, there are a number of ``blended'' clinical labor
types which often include RNs as one of the staffing types being
averaged together. Blended clinical labor types have been a historical
part of PFS services since we adopted the current PE methodology. We
have done our best to identify which staffing types, including RNs, are
included in these blends along with how they are averaged together to
arrive at the final clinical labor pricing. We also note for the
commenter that the pricing for the RN (L051A) clinical labor type is
drawn directly from BLS wage data and the inclusion of RNs in other
``blended'' clinical labor types has no effect on the pricing of the
L051A category itself.
Comment: A commenter stated that CMS must reevaluate the pricing
for the Behavioral Health Care Manager (L057B) clinical labor type. The
commenter noted that CMS maintained the current clinical labor pricing
for the Behavioral Health Care Manager clinical labor type rather than
update it in the CY 2022 PFS final rule because, although the BLS data
reflected a decreased clinical labor rate for the Behavioral Health
Care Manager labor type, CMS did not believe that the typical wages had
decreased for this clinical labor type given that every other clinical
labor type had increased (86 FR 65022). The commenter stated that
growth for Behavioral Health Care Managers has increased on a similar
trajectory as other clinical labor types and has in fact outpaced wage
growth for other types of behavioral health providers. The commenter
stated that BLS data indicates that salaries for clinicians who work as
Behavioral Health Care Managers have increased at a rate of
approximately 5 percent per year between 2021 and 2023, outpacing the
wage increases for other types of related practitioners, such as
psychiatrists, nurse practitioners, and physician assistants, which
increased at rates below 4 percent per year. The commenter stated that
Behavioral Health Care Manager wages increased at a pace that is
consistent with the increase in wages for other clinical labor types
(such as registered nurses, licensed practical nurses, and medical
assistants), increasing by 27.2 percent from 2017 to 2023, compared
with a 30.2 percent increase among other clinical labor types during
the same period. The commenter requested that rather than holding the
clinical labor rate for Behavioral Health Care Managers steady, the
rate should be increased at a rate similar to the costs associated with
other clinical labor types.
Response: We appreciate the additional information provided by the
commenter with regards to the Behavioral Health Care Manager (L057B)
clinical labor type. However, we continue to believe that the proposed
pricing for this clinical labor type remains accurate, as it was based
directly on BLS wage data (BLS category 21-1018: Substance Abuse,
Behavioral Disorder, and Mental Health Counselors) rather than relying
on a crosswalk or third party information. Although we understand that
it appears unfair that the L057B clinical labor type maintained the
same pricing while all of the other clinical labor types increased in
valuation, this was due to the fact that the L057B type had been valued
much more recently than the other clinical labor types. The L057B
clinical labor type was added to the PFS for the CY 2017 final rule and
therefore was priced at $0.57 per minute based on then-current rates
for genetic counselors (81 FR 80350). Almost all of the other clinical
labor types were last valued based on 2002 wage data, which caused the
L057B clinical labor type to be artificially inflated in pricing
relative to the other clinical labor types. For example, before the
current clinical labor pricing update, Behavioral Health Care Managers
were priced at $0.57 per minute, higher than the $0.51 per minute
valuation of the Registered Nurse (L051A) clinical labor type, which
clearly did not reflect market-based salaries. The commenter included a
table in their submission indicating that salaries for Registered
Nurses are approximately 40 higher than salaries for Behavioral Health
Care Managers, which matches our current proposed pricing for these
clinical labor types ($0.76 and $0.57 respectively). We believe that
the current clinical labor pricing update has brought valuation of the
L057B clinical labor type into relativity with the other clinical labor
types by virtue of valuing all of them at the same time.
After consideration of the comments, we did not receive any new
wage data for use in clinical labor pricing. Therefore, we are
finalizing the clinical labor prices as proposed in Table 8 without
refinement.
d. Technical Corrections to Direct PE Input Database and Supporting
Files
We received the following comments on technical corrections to the
direct PE input database and supporting files:
Comment: Several commenters, including the RUC, requested that CMS
separately identify and pay for high-cost disposable supplies.
Commenters highlighted the outsized impact that high-cost disposable
supplies have within the current practice expense RVU methodology,
which not only accounts for a large amount of direct practice expense
for these supplies but also allocates a large amount of indirect
practice expense into the PE RVU for the procedure codes that include
these supplies. Commenters stated that if high-cost supplies were paid
separately with appropriate HCPCS codes, the disproportionate indirect
expense would no longer be associated with that service, with the
result that indirect PE RVUs would be redistributed throughout the
specialty practice expense pool and the practice expense for all other
services. Commenters requested that CMS separately identify and pay for
high-cost disposable supplies priced more than $500 using appropriate
Healthcare Common Procedure Coding System (HCPCS) codes. Commenters
provided several examples from the proposed rule where they stated this
policy would be appropriate, including new HCPCS code GMEM1, the
potential for a new add-on service based on tympanostomy CPT code
69433, and the price of the SD248 supply (human amniotic membrane
allograft mounted on a non-absorbable self-retaining ring). In each
case, commenters stated that these issues would be better addressed
through the creation of standalone Q codes separately paid from the PFS
so those prices could be monitored and, when appropriate, updated
annually.
Response: We have received a number of prior requests from
interested parties, including the RUC, to implement these separately
billable alpha-numeric Level II HCPCS codes to allow practitioners to
be paid the cost of high cost disposable supplies per patient encounter
instead of per CPT code. We stated at the time, and we continue to
believe, that this option presents a series of potential problems that
we have addressed previously in the context of the broader challenges
regarding our ability to price high cost disposable supply items. We
are therefore not finalizing the implementation of standalone Level II
HCPCS codes for high cost disposable supplies at this time. For further
discussion of this issue, we direct the
[[Page 97735]]
reader to our discussion in the CY 2011 PFS final rule with comment
period (75 FR 73251).
We are aware of the issues with the current PE methodology caused
by very expensive supply and equipment items, and this is a subject
that we may consider for future rulemaking alongside other updates to
the PE methodology. We appreciate the continued feedback from
commenters as we consider potential approaches to this complicated
topic.
Comment: A commenter echoed the request from other interested
parties that CMS separately identify and pay for high-cost disposable
supplies priced more than $500. This commenter stated that they
believed these services should be paid outside of the PFS, since PFS
budget neutrality rules compound the challenge of appropriately valuing
high-cost technology inputs without underpaying for physician
professional services. The commenter recommended that CMS designate
such services as office based procedures under a new place of service
designation and establish payment under the outpatient prospective
payment system (OPPS)/ambulatory surgical center rulemaking instead of
the PFS.
Response: We appreciate the feedback from the commenter on
potential methods for implementing separate payment for high-cost
disposable supplies. Although we have no current plans for such a
policy, we will take under consideration for potential future
rulemaking.
Comment: Several commenters asked for clarification regarding the
proposed PE RVUs for HCPCS code G2251. Commenters stated that the
proposed non-facility and facility PE RVUs for HCPCS code G2251 showed
a significant reduction from 0.15 to 0.00 despite no mention of a
policy proposal for this service. Commenters stated that they wanted to
bring this valuation to the attention of CMS and sought clarification
on whether this was a data entry error or an intentional change related
to the proposed Advanced Primary Care Management (APCM) codes.
Response: We appreciate the commenters for bringing this issue to
our attention, and we clarify that the published 0.00 PE RVUs for HCPCS
code G2251 was an unintended technical error. When we investigated this
issue, we found that it was due to a previously finalized crosswalk: we
finalized a policy in the CY 2021 PFS final rule to value HCPCS code
G2251 identically to HCPCS code G2012 (85 FR 84532). However, we also
proposed to delete HCPCS code G2012 for CY 2025 which inadvertently
resulted in HCPCS code G2251 crosswalking over a zero value for its PE
RVUs. Since HCPCS code G2012 will no longer exist in CY 2025, we are
finalizing the removal of this crosswalk for HCPCS code G2251 which
should correct this error and restore its PE RVUs.
Comment: A commenter requested that CMS consider changing the
assistant at surgery payment policy indicator to ``2'' for CPT codes
37211, 37212, 37242, and 37197 to allow for the use of assistant
surgeons. The commenter stated that these transcatheter procedures
involve the infusion of thrombolytic therapy, precise embolization of
arteries, and foreign body retrieval, which have the potential to be
extremely technical in nature and may require a highly functional team,
including an assistant surgeon in select cases. The commenter stated
that select cases that are particularly challenging may necessitate the
skills of two operators to perform distinct parts of the navigation and
procedure for the precise and safe delivery of thrombolytic therapy and
vascular embolization devices, as well as the safe and effective
retrieval of foreign bodies. The commenter stated that changes to these
payment policy indicators will ensure patient procedural safety and
bring policy alignment to these complex transcatheter procedures.
Response: The four CPT codes identified by the commenter each
currently have an assistant at surgery payment policy of ``1'' under
which an assistant at surgery may not be paid. After reviewing the four
CPT codes identified by the commenter, we agree that an assistant at
surgery may be medically necessary in some particularly challenging
cases. However, we believe that it would be more accurate to finalize
an assistant as surgery payment policy of ``0'' rather than the
requested ``2'', which establishes that the payment restriction for an
assistant at surgery applies to this procedure only if supporting
documentation is submitted to establish medical necessity. We believe
that this will ensure that an assistant at surgery will only be
employed in the particularly challenging and medically necessary cases
described by the commenter. Therefore we are finalizing an assistant at
surgery payment policy indicator of ``0'' for CPT codes 37211, 37212,
37242, and 37197.
Comment: A commenter stated that the direct PE inputs for CPT code
65426 do not contain a supply item for human amniotic membrane
allograft product (the SD247 supply). The commenter stated that as a
result, the practice expense valuation does not account for the
significant cost of this item when it is purchased and used. The
commenter stated that while they are working with stakeholders to
submit a potentially misvalued CPT code request for review in future
rulemaking, they also wanted to note this issue and concern within the
public comment period for this CY 2025 PFS rule.
Response: We appreciate the feedback from the commenter on this
topic, and we would encourage them to continue pursuing the potentially
misvalued code process if they believe that CPT code 65426 does not
properly capture its typical direct PE inputs. We note the commenter
did not present data indicating that the use of the expensive $835
SD247 supply is typical in CPT code 65426. We are not finalizing any
changes to the code at this time.
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
[[Page 97736]]
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 referred 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 referred 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 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
[[Page 97737]]
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.
As we stated in the proposed rule, 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 will continue to
study possible alternatives, and would include analysis of updated PPIS
data, as part of our ongoing work. In the meantime, we requested
general information from the public on ways that CMS may continue work
to improve the stability and predictability of any future updates.
Specifically, we requested feedback from interested parties regarding
scheduled, recurring updates to PE inputs for supply and equipment
costs.
We stated that 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 stated that more
frequent updates may have the unintended consequence of
disproportionate effects of various supplies and equipment that have
newly updated costs.
Further, we solicited 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 sought 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.
Comment: Numerous commenters expressed concerns regarding CMS's
current PE methodology, particularly highlighting its inadequacies in
accommodating modern medical technologies and services, such as
Software as a Medical Device (SaMD) and artificial intelligence (AI).
These commenters stated that there is a need for CMS to revise its PE
methodology to better reflect the actual costs of running medical
practices today, which includes more frequent updates and the
incorporation of direct costs for software and innovative technologies.
Many also supported the AMA's ongoing Physician Practice Information
Survey (PPIS) to ensure updated and accurate data informs PE
calculations. Commenters urged CMS to collaborate closely with medical
associations and incorporate broad stakeholder feedback without
increasing reporting burdens, particularly for smaller practices.
Response: We thank commenters for their feedback and may consider
this information for future rulemaking.
C. Potentially Misvalued Services Under the PFS
1. Background
Section 1848(c)(2)(B) of the Act directs the Secretary to conduct a
periodic review, not less often than every 5 years, of the relative
value units (RVUs) established under the PFS. Section 1848(c)(2)(K) of
the Act requires the Secretary to periodically identify potentially
misvalued services using certain criteria and to review and make
appropriate adjustments to the relative values for those services.
Section 1848(c)(2)(L) of the Act also requires the Secretary to develop
a process to validate the RVUs of certain potentially misvalued codes
under the PFS, using the same criteria used to identify potentially
misvalued codes, and to make appropriate adjustments.
As outlined in section II.E. of this final 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 practice expense (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
[[Page 97738]]
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 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
[[Page 97739]]
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 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
noted in the proposed rule that no references were 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 noted in the proposed
rule that the
[[Page 97740]]
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 stated that we believed this issue would
benefit from further review by the medical community and welcomed
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
The nominator further asserted that this code family is potentially
misvalued because surgical practice for these procedures has evolved
since 1995. Approximately 30 years ago, osteotomies were infrequently
performed and usually reserved for addressing completely ankylosed or
fused spinal segments.\8\ However, according to the nominator,
contemporary surgical techniques often involve posterior osteotomies to
release multiple stiff vertebral segments, thereby enhancing coronal
correction and reducing thoracic hypokyphosis. In addition to changes
in surgical techniques over time, there are notable shifts in the
trends regarding the utilization of osteotomies. For instance, between
2007 and 2015, the use of posterior osteotomies in scoliosis cases
nearly doubled, increasing from 17 percent to 35 percent.\9\
Additionally, 73 percent of patients undergoing scoliosis surgery
received posterior osteotomies.\4\ This information supports the
nominator's assertion that there have been notable changes in the
surgical practice for these codes over time.
---------------------------------------------------------------------------
\8\ Ponte, Alberto et al. ``The True Ponte Osteotomy: By the One
Who Developed It.'' Spine deformity vol. 6,1 (2018): 2-11.
doi:10.1016/j.jspd.2017.06.006.
\9\ Shaheen, Mohammed et al. ``Complication risks and costs
associated with Ponte osteotomies in surgical treatment of
adolescent idiopathic scoliosis: insights from a national
database.'' Spine deformity vol. 10,6 (2022): 1339-1348.
doi:10.1007/s43390-022-00534-4.
---------------------------------------------------------------------------
Lastly, the nominator highlighted what they believe is 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 stated in the proposed
rule that we concurred that CPT codes 22210, 22212, 22214, and 22216
were 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 proposed to consider this code family as
potentially misvalued and expressed appreciation for the detailed
information submitted by the nominator with sufficient supporting
evidence. We stated that we believed that this code family would
benefit from a comprehensive review by the RUC, and we welcomed
comments on a broader understanding of these codes. Additionally, we
sought input on current standard billing practices. For example,
information on whether the standard of practice has evolved over time,
and if so, how it has evolved, could aid in identifying potential
coding issues related to this matter.
We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: Many commenters, including the AMA RUC, supported our
proposal. The RUC stated that, since the osteotomy of the spine codes
(CPT codes 22210, 22212, 22214, and 22216) were last reviewed in 1995,
these codes may benefit from updated descriptions and consideration of
bundling with related procedures. They suggested options such as
developing add-on codes for segment-specific osteotomies or integrating
these into new deformity fusion codes. They further stated they will
place the nominated osteotomy codes (CPT codes 22210, 22212, 22214, and
22216) on the next Level of Interest (LOI) list for review at the
January 2025 RUC meeting.
Response: We thank the commenters for their feedback.
Comment: A few commenters disagreed that the osteotomy of spine
codes are potentially misvalued. The commenters stated that the
procedures are primary interventions, not add-ons, and that the current
global periods, inpatient days, and intraservice work descriptions
accurately reflect the complexity of adult deformity surgery. They
further stated that surgical techniques have not changed significantly
and they believe that the codes are accurately valued and that altering
them could disrupt coding practices and negatively impact patient care.
Response: While we acknowledge the comments asserting that CPT
codes 22210, 22212, 22214 and 22216 are appropriately valued, we agree
with the RUC that services such as those
[[Page 97741]]
described by the nominator would benefit from review by the AMA RUC.
Therefore, we are finalizing our proposal to finalize CPT codes 22210,
22212, 22214 and 22216 as potentially misvalued.
(2) CPT Code 27279
CPT code 27279 (Arthrodesis, sacroiliac joint, percutaneous or
minimally invasive (indirect visualization), with image guidance,
includes obtaining bone graft when performed, and placement of
transfixing device) (090 day global code) has been 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 requested 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 in the
medical community 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 recognized 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 noted 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
did not propose to consider this code as potentially misvalued, and we
instead sought comments and additional studies from the broader medical
community regarding whether this code should be priced under the PFS
for the nonfacility/office setting.
We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: Many commenters stated that they opposed creating a
nonfacility/office payment rate for CPT code 27279 due to patient
safety concerns regarding this service being performed in the office
setting. These commenters agreed with CMS on the lack of sufficient
safety evidence for CPT code 27279 in nonfacility settings and
recommended to maintain the current policy with respect to CPT code
27279 and not extend its use to nonfacility settings. They expressed
that they were unaware that the service described by CPT code 27279 was
being performed in nonfacility settings and stated their belief that it
would be challenging for a medical practice to consistently meet the
sanitary requirements necessary to safely perform this procedure on an
ongoing basis. In addition, one commenter indicated that although this
service is performed in hospital outpatient departments (HOPDs) and
ambulatory surgical centers (ASCs), both of those settings have
rigorous conditions of participation that hold them to higher safety
standards than physician offices. Regarding patient safety
specifically, commenters shared CMS's concerns regarding the safety of
delivering sacroiliac joint procedures in the office setting. The
majority of the commenters recommended that CMS maintain its current
policy and refrain from valuing CPT code 27279 in the non-facility
setting and not adopt nonfacility PE values for CY 2025.
Response: We thank commenters for their feedback.
Comment: A few commenters supported establishing payment in the
nonfacility/office setting for CPT code 27279. Commenters stated that
the procedure described by CPT code 27279 can be safely performed in an
office or nonfacility setting by referencing studies showing a low
complication rate in OBL. They indicated that establishing direct PE
inputs for the nonfacility setting would improve patient access to this
service and supported obtaining direct PE inputs to increase patient
access to care.
Response: We appreciate the comments and the additional information
to support the establishment of nonfacility/office valuation for CPT
code 27279. However, after review, the studies submitted by the
nominator were not found to be persuasive. While we are seeking further
information, commenters stated that they were not aware of any studies
demonstrating the quality or safety of this procedure in a nonfacility
setting. Based on Medicare claims data, CPT code 27279 is not regularly
furnished in the nonfacility/office setting; the majority of
utilization has occurred in the facility setting, with less than 1.0%
in the nonfacility setting over the past 7 years. As with last year,
the majority of commenters recommended that CMS maintain its current
policy regarding CPT code 27279 and not extend its use to nonfacility
settings. Since this service is not routinely furnished in a
nonfacility setting, we believe that this procedure should only be paid
in the facility settings at this time. Therefore, for CY 2025, we are
finalizing our proposal not to nominate CPT code 27279 as potentially
misvalued.
We continue to welcome the submission of new information regarding
these services that was not part of our CY 2024 review of CPT code
27279. We would appreciate receiving any additional information,
particularly published studies with sound methodology (for example, a
systematic review or meta-analysis covering at least three databases)
or new data.
(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 PEs that were last reviewed in 2017. This
code was nominated as potentially misvalued
[[Page 97742]]
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 and 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 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 was 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 9).
[GRAPHIC] [TIFF OMITTED] TR09DE24.010
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 proposed to
maintain the current direct PE supply and equipment inputs for CPT code
95800. While we did not propose to review CPT code 95800 as potentially
misvalued for CY 2025, we sought public comments on this nomination. In
particular, we sought comments on whether the typical procedure
described by CPT code 95800 now involves the use of a disposable HSAT
device rather than reusable equipment.
We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: Several commenters supported our proposal to not nominate
CPT code 95800 as potentially misvalued and advised us to continue
monitoring this issue. The commenters reported a mix of disposable and
reusable HSAT devices in use, noting that disposable devices have
become more common since the COVID-19 PHE. The American Academy of
Sleep Medicine (AASM) stated that HSAT data from AASM accredited sleep
facilities indicated that, while there is an observed increase in the
use of disposable HSAT devices, this does not suggest that members have
converted to using them at this time. According to AASM, their survey
data in 2022 indicated that the majority were still
[[Page 97743]]
using reusable HSAT devices. They generally believed there is
insufficient information to determine whether disposable devices are
more typical than reusable ones at this time, and therefore, they did
not support the nomination of CPT code 95800 as potentially misvalued.
They stated that further data collection would be needed to confirm
whether the typical practice is now using disposable devices and
suggested continued monitoring. Additionally, they opposed the removal
of the Oximetry and Airflow device (EQ336), as it remains necessary for
certain procedures.
Response: We thank commenters for their feedback.
Comment: The manufacturer and distributor of the WatchPAT
disposable HSAT devices stated that a disposable HSAT offers the same
accuracy and reliability as other WatchPAT products, but allows for
quicker access to sleep data, particularly benefiting those in rural
areas, enables physicians to better extend care, and reduces
reinfection risks. Using their internal data, the device manufacturer
stated that in 2023, 48 percent of WatchPAT tests used the disposable
WatchPAT One device, reflecting a 4--8 percent annual increase since
2020; by the first half of 2024, this trend continued, with 53 percent
of WatchPAT tests in the U.S. using the disposable HSAT device. Based
on their utilization data and projections, the device manufacturer
believed that there is strong evidence that the typical procedure in
2024 will involve the use of disposable rather than reusable HSAT
equipment. The device manufacturer indicated that they do not have data
on the number of Medicare patients using the disposable HSAT device,
though they do not believe there is a significant difference in the use
of reusable versus disposable equipment among Medicare or home sleep
testing populations.
Response: We thank commenters for their summary of internal data
and their feedback.
We acknowledge that the practice of medicine is evolving, and in
clinically appropriate and effective circumstances, there may be
support for transitioning from reusable to disposable HSAT equipment.
We also recognize that the PE inputs for such services should be
accurately determined to reflect typical clinical practice. However,
after reviewing the public comments, we believe there is insufficient
information at this time to demonstrate whether disposable or reusable
HSAT devices are more commonly used than reusable HSAT equipment.
Therefore, we are finalizing our proposal not to nominate CPT code
95800 as potentially misvalued.
However, we look forward to considering any additional information
in the future as to whether disposable or reusable HSAT devices are
more common. As suggested by the commenters, we believe more
information is needed to confirm whether disposable devices are now the
typical practice.
(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 noted in the proposed
rule 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 refer to these prior 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 (FNA) 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 FNA 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 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 PE inputs.
According to the nominator, FNA 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 FNA 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 FNA 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 FNA should ideally
be conducted exclusively in nonfacility
[[Page 97744]]
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 stated 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 stated the rarity of Medicare billing for this code.
Additionally, they emphasized the importance of outpatient thyroid FNA
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 noted in the
proposed rule that these codes have been recently reviewed multiple
times through the annual PFS rulemaking process. We clarified once
again that we disagree with the nominator that this code family is
potentially misvalued. We acknowledged 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
noted that these codes underwent thorough RUC survey and review
processes during the October 2017 and January 2018 RUC meetings. Based
on these considerations, we stated that we disagreed with the assertion
that this code family is potentially misvalued. Nevertheless, we
welcomed comments on whether these codes should be re-reviewed in light
of the arguments made by the nominator.
We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: Several commenters supported our proposal not to nominate
CPT codes 10005, 10009, and 10021 as potentially misvalued and did not
support a resurvey of the codes at this time, stating that these sets
of codes have undergone several reviews in recent years.
Response: We thank the commenters for this feedback
Comment: The AMA RUC stated that these codes do not necessarily
need to be re-evaluated and urged CMS to correct the mathematical error
underlying the current work RVUs for CPT codes 10005, 10009, and 10021,
and to accept the previous RUC-recommended work RVUs of 1.63 for CPT
code 10005, 2.43 for CPT code 10009, and 1.20 for CPT code 10021. The
RUC stated that the mathematical error occurred when CMS mistakenly
double-counted the utilization of new codes that included bundled image
guidance. The RUC believes that CMS misinterpreted the AMA's
utilization crosswalk recommendations, emphasizing that the figures in
the source utilization and utilization destination columns in Table 12
from the CY 2019 PFS final rule should be identical. Additionally, they
stated that they provided the actual claims data from CY 2019 to
evaluate the accuracy of CMS's RVU pool estimates during the CY 2019
rulemaking process. Lastly, a few commenters stated that they are not
suggesting the entire code family is misvalued, but rather that only a
subset of nominated FNA procedures is in question.
Response: The RUC continues to state that it believes there was an
error in the utilization crosswalk for this code family during the CY
2019 review. In the CY 2019 PFS final rule, we refined the work RVUs of
CPT codes 10021, 10005, and 10009 based on changes in surveyed work
time and the relationships among the codes. For example, for CPT code
10021, we adjusted the work RVU from the RUC-recommended value of 1.20
to a finalized value of 1.03. This decision was driven by a decrease in
the recommended intraservice time from 17 minutes to 15 minutes (a 12
percent reduction) and a decrease in total time from 48 minutes to 33
minutes (a 32 percent reduction). In contrast, the RUC-recommended work
RVU only decreased from 1.27 to 1.20, representing a reduction of just
over 5 percent. To better reflect these decreases in surveyed work
time, we determined a work RVU of 1.03 was more accurate, using a
crosswalk to CPT code 36440. It is important to note that the primary
rationale for refining the work RVU did not reference the utilization
crosswalk. Additionally, based on our previously explained rationale,
we also note that the two columns--source utilization and utilization
destination--do not need to be identical. Our review of these codes and
our rationale for finalizing the current values are discussed in the CY
2019 PFS final rule (83 FR 59517 through 59521) and the CY 2021 PFS
final rule (85 FR 84602 through 84604).
In continuing to repeat the same positions regarding the
utilization crosswalk, however, the RUC has not provided any new
information that was not already presented for the previous CMS reviews
of these codes. In the event that there is a new RUC review of these
services, as opposed to a restatement of the RUC's previous review, we
would look forward to receiving any additional information or new data.
We continue to welcome the submission of new information regarding
these services that was not part of the previous CY 2019 and CY 2021
reviews of the code family.
Comment: Several commenters expressed concerns about the RVU
reduction for the FNA codes, noting that since 2018, reduced
reimbursement has led to an 18 percent decline in FNA procedures. They
highlighted that this decrease disrupts continuity of care, causing
delays in diagnosis and treatment, especially affecting patients in
rural and low-income areas. Furthermore, they stated that the shift of
FNA procedures from the office to facility setting has resulted in a
524 percent increase in Medicare costs and a rise in hospital-based
services. Commenters also pointed out that Medicare claims from
calendar year 2022 also indicate a shift in the type of clinician
performing the procedure, with 52.3 percent of FNAs being performed by
radiologists and only 17.6 percent by endocrinologists. They stated
that radiologists often lack the capacity for the comprehensive follow-
up care that would be provided by endocrinologists. Overall, they
stated that the RVU reduction for the FNA codes would result in an
increase in hospital-based facility fees and longer wait times for
patients, would burden the healthcare system, and limit training
opportunities for endocrinology fellows, potentially compromising
future care quality and access.
Response: We appreciate the information provided by commenters
regarding the impact of the current valuation on the setting of care
where these services are provided. We welcome additional information on
this issue; however, we continue to believe, as we have stated in past
rulemaking,
[[Page 97745]]
that the FNA codes are accurately valued.
After consideration of the public comments, we continue to believe
that the current valuation accurately reflects the typical work and
direct PE inputs involved in furnishing FNA services. Therefore, for CY
2025, we are finalizing our proposal not to nominate CPT codes 10021,
10004, 10005, and 10006 as potentially misvalued.
(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 stated in the proposed rule that we recognized 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 stated that we believed 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 solicited comments on several alternatives that we were
considering for adoption in the CY 2025 PFS final rule or future
rulemaking. First, we solicited comment on whether to establish a new G
code that accounts for the work and PE 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 stated that 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 solicited 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 solicited 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.
We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: We received several comments, including from the RUC,
stating that rather than developing new codes to describe tympanostomy
tube delivery devices and/or systems, CMS should establish national
pricing for Category III CPT code 0583T (Tympanostomy (requiring
insertion of ventilating tube), using an automated tube delivery system
and iontophoresis local anesthesia). This code, implemented in 2020,
includes a vignette describing its use for a child (the patient sitting
on the parent or guardian's lap) and does not include general
anesthesia. Commenters stated that national pricing for CPT code 0583T
would allow procedures to be furnished without general anesthesia,
saving families from taking time off work and avoiding the costs and
risks associated with general anesthesia. One commenter stated that CPT
code 31295 (Nasal/sinus endoscopy, surgical, with dilation (eg, balloon
dilation); maxillary sinus ostium, transnasal or via canine fossa) is
similar to the Category III CPT code 0583T procedure with respect to
the intensity and invasiveness of the procedure, preparation time for
the procedure, or total time to complete the procedure which is around
35-40 mins. Therefore, the commenter stated CMS can consider CPT code
31295 as the appropriate crosswalk reference. The RUC stated that it
believes that this CPT code may be used to report this service as
described and suggested that CMS should not create duplicate ways to
report the same procedure.
Response: We thank comments for their feedback. We believe that CPT
code 0583T does not adequately reflect the work and PEs for a procedure
that uses innovative tympanostomy tube delivery devices and/or systems
falling under emerging technology and services categories.
Additionally, CPT code 0583T represents only one type of technology
used for this service, whereas it is our understanding that there are
multiple types of tympanostomy tube delivery devices and/or systems,
and we do not want to limit payment for only one device. Therefore, we
are not establishing a national price for Category III CPT code 0583T
at this time. We appreciate the comments and feedback regarding the
need for an appropriate rate for Category III CPT code 0583T and the
potential for a crosswalk reference, however as discussed previously we
will not be finalizing national pricing for CPT code 0583T.
Comment: Many commenters collectively supported the creation of
additional coding to describe the resources associated with innovative
tympanostomy tube delivery devices and/or systems. Commenters generally
preferred that CMS establish a new G code, specifically an add-on G
code with inputs based on CPT code 69433, for tympanostomy procedures,
particularly using innovative surgical technology for patients at risk
of movement during the procedure, such as pediatric patients. These
commenters referenced the benefits of these minimally invasive, in-
office procedures, which eliminate the risks associated with general
anesthesia and offer quicker recovery, fewer infections, and improved
access to care. They also stated that this innovative technology can be
cost-effective, particularly for vulnerable and underserved populations
with multiple health conditions. Additionally, the commenters stated
that the ability to perform these procedures in an office setting,
without the need for general anesthesia, significantly reduces
associated risks and recovery time. Commenters stated that minimizing
the use of general anesthesia is especially beneficial for pediatric
patients, who are at a higher risk for anesthesia-related
complications. However, while supporting the establishment of an add-
[[Page 97746]]
on G-code, a few commenters indicated that the current CPT code 69433
was designed for cooperative adults using standard instruments and
therefore does not adequately reflect the resources and expertise
involved.
Response: We appreciate the feedback from commenters and thank them
for highlighting that these innovative tympanostomy procedures can be
particularly beneficial for patients with additional health conditions,
some of which may require multiple procedures and that CPT code 69433
may not fully account for the resources and expertise involved, or the
tube delivery devices and/or systems.
We agree with commenters that these minimally invasive, in-office
procedures can offer significant benefits, including reduced risks
associated with general anesthesia, quicker recovery, fewer infections,
and improved access to care. We also agree with commenters that the
current coding is inadequate to reflect the different kinds of
technologies used to conduct tympanostomies on children in the office
setting, particularly those that do not require general anesthesia.
Therefore, for CY 2025, we are finalizing the creation of a new add on
G code, HCPCS code G0561 (Tympanostomy with local or topical anesthesia
and insertion of a ventilating tube when performed with tympanostomy
tube delivery device, unilateral (List separately in addition to 69433)
(Do not use in conjunction with 0583T)) to be billed with 69433 in
order to describe the additional resource costs associated with using
the innovative tympanostomy tube delivery devices and/or systems
falling under emerging technology and services categories and are
finalizing contractor pricing for CY 2025.
Lastly, we received several comments regarding CPT codes 21076-
21089 which describe maxillofacial prosthodontic procedures (see Table
10). This code family was not discussed in the CY 2025 PFS proposed
rule. Therefore, these comments are outside the scope of proposals
included in the proposed rule, and we would not ordinarily summarize
and respond to them in this final rule. However, we note that the
commenters are welcome to submit these codes by February 10 of the
coming year for consideration as potentially misvalued for the CY 2026
PFS proposed rule. See above for more information on how to submit a
nomination for a potentially misvalued code.
[GRAPHIC] [TIFF OMITTED] TR09DE24.011
D. Payment for Medicare Telehealth Services Under Section 1834(m) of
the Act
As discussed in prior rulemaking, several conditions must be met
for Medicare to make payment for telehealth services under the PFS. See
further details and full discussion of the scope of Medicare telehealth
services in the CY 2018 PFS final rule (82 FR 53006), 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 final 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
[[Page 97747]]
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.
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. Services that fall outside the definition of telehealth
service 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.
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
[[Page 97748]]
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 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 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 11.
[[Page 97749]]
[GRAPHIC] [TIFF OMITTED] TR09DE24.012
[[Page 97750]]
[GRAPHIC] [TIFF OMITTED] TR09DE24.013
Many of the services listed above were added to the Medicare
Telehealth Services List on a temporary basis during the PHE for COVID-
19, 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 submissions received this calendar year were requests to add
services, including several of which are assigned provisional status on
Medicare Telehealth Services List, to the Medicare Telehealth Services
List on a permanent basis. For services currently assigned provisional
status on the Medicare Telehealth Services List, 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. Therefore, we are not
making determinations on whether 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 their
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. Under section 1834(m)(2)(A)
of the Act, Medicare pays the same amount for a telehealth service as
if the service is furnished in person (88 FR 78862). A service is
subject to the provisions of section 1834(m) of the Act when at least
some elements of the service, when delivered via telehealth, are a
substitute for an in-person, face-to-face encounter, and all of those
face-to-face elements of the service are furnished using an interactive
telecommunications system as defined in Sec. [thinsp]410.78(a)(3) (88
FR 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 proposed to
not add this service to the Medicare Telehealth Services List.
We received public comments on this proposal. The following is a
summary of the comments we received and our responses.
Comment: We received some comments requesting that we remove the
criterion we use in Step 2 of our 5-step process to consider whether a
services is analogous to an in-person service. The commenters stated
that this service may be performed virtually alongside an E/M service
furnished via Medicare telehealth. The commenters stated that a
practitioner can provide this service in conjunction with a separately
reportable telehealth service on the same day, and expressed concern
that unless this code is added to the Medicare Telehealth Services
List, there could be claims processing errors if the continuous glucose
monitoring service is reported with Medicare telehealth POS codes.
Response: We believe that Step 2 of our 5-step process plays a
critical role in ensuring that any service being considered to be added
on the Medicare Telehealth Services List is sufficiently analogous to
an in-person service in terms of both the clinical benefit provided and
the way it is furnished. This criterion ensures that services delivered
virtually offer the same, if not similar diagnostic and treatment value
as in-person visits. Removing Step 2 would undermine this goal.
[[Page 97751]]
Furthermore, Section 1834(m) of the Act requires the Secretary to pay
to a physician or practitioner located at a distant site that furnishes
a telehealth service to an eligible telehealth individual 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. As discussed in CY 2025 PFS proposed rule
and this CY 2025 PFS final rule, this limits payment for Medicare
telehealth services to those services that are, in whole or in part,
inherently a face-to-face service.
We thank commenters for the additional information and concerns. We
continue to believe that this service does not meet the requirements to
be added to the Medicare Telehealth Services List because the service
does not ordinarily involve the presence of, or interaction with, the
patient.
After consideration of public comments, we are finalizing as
proposed to not add this service on 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. 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.
These services are currently on the Medicare Telehealth Services
List and are assigned provisional status. In the CY 2022 PFS final rule
(86 FR 65054 through 65055), we explained that some services were added
temporarily to the Medicare Telehealth Services List on an emergency
basis to allow practitioners and beneficiaries to have access to
medically necessary care while avoiding both risk for infection and
further burdening healthcare settings during the PHE for COVID-19. As
explained in the CY 2025 PFS proposed rule, rather than selectively
adjudicating only those services for which we receive requests for
potential permanent status, we intend to first complete a comprehensive
analysis of all provisional codes currently on the Medicare Telehealth
Services List before determining which codes should be made permanent.
We therefore stated in the proposed rule that while we would consider
the requestors' input in future rulemaking, we were 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.
We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: Many commenters supported these services remaining on the
Medicare Telehealth Services List, along with additional requests to
revise their status of from provisional to permanent. In addition, we
also received a resubmission of the original request to revise the
status of these codes from provisional to permanent with no changes in
the information provided.
Response: As we stated in the proposed rule, we are not considering
whether to recategorize provisional codes as permanent in this
rulemaking for CY 2025 because we intend to conduct a comprehensive
analysis of all such provisional codes, which we expect to address in
future rulemaking.
After consideration of public comments, we are finalizing as
proposed to maintain these services on the Medicare Telehealth Services
List on a provisional basis.
(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 (88 FR 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-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 did not propose
to revise the status of codes from provisional to permanent in the
proposed rule because we intend to conduct a comprehensive review.
Therefore, we did not propose to assign them to the Medicare Telehealth
Services List with permanent status.
We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: Many commenters supported these services remaining on the
Medicare Telehealth Services List, along with additional requests to
revise the status of codes from provisional to permanent. Some
commenters recommended that we maintain the designation of these codes
as provisional on the Medicare Telehealth Services List to allow for
additional data and support to be collected for future requests to
revise the status of codes from provisional to permanent.
Response: As we stated in the proposed rule, we are not considering
in rulemaking for CY 2025 whether to recategorize provisional codes as
permanent because we intend to conduct a comprehensive analysis of all
such provisional codes, which we expect to address in future
rulemaking.
After consideration of public comments, we are finalizing as
proposed to maintain these services on the Medicare Telehealth Services
List on a provisional basis.
(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 did not propose to revise the status of
codes from provisional to permanent in the proposed rule because we
intend to conduct a comprehensive review. Therefore, we did not propose
to either remove these services from or to assign them permanent status
on the Medicare Telehealth Services List.
We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: Many commenters supported these services remaining on the
Medicare Telehealth Services List, along with additional requests to
revise the status of codes from provisional to permanent.
[[Page 97752]]
Response: We are not considering in this rulemaking for CY 2025
whether to recategorize provisional codes as permanent because we
intend to conduct a comprehensive analysis of all such provisional
codes, which we expect to address in future rulemaking.
After consideration of public comments, we are finalizing as
proposed to maintain these services on the Medicare Telehealth Services
List on a provisional basis.
(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 did not propose to revise the status of codes from
provisional to permanent in the proposed rule because we intend to
conduct a comprehensive analysis of all such provisional codes, which
we expect to address in future rulemaking. Therefore, we did not
propose to assign them permanent status on the Medicare Telehealth
Services List.
We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: Many commenters requested that these services be added to
the Medicare Telehealth Services List on a permanent basis, citing
concerns that, due to expiring PHE flexibilities, they believe the
codes are scheduled to be removed from Medicare Telehealth Services
List on December 31, 2024.
Response: As we stated in the proposed rule, we are not considering
in this rulemaking for CY 2025 whether to recategorize provisional
codes as permanent because we intend to conduct a comprehensive
analysis of all such provisional codes, which we expect to address in
future rulemaking. We clarify that we will retain these Therapy/
Audiology/Speech Language Pathology codes on the Medicare Telehealth
Services List with a provisional status after the expiration on
December 31, 2024, of current statutory PHE-related telehealth policies
that have expanded the scope of practitioners that could furnish and be
paid for telehealth services.
After consideration of public comments, we are finalizing as
proposed to maintain these services as provisional 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 previously in this CY 2025 PFS final rule, section 1834(m) of
the Act requires the Secretary to pay to a physician or practitioner
located at a distant site that furnishes a telehealth service to an
eligible telehealth individual 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. As discussed
in the CY 2025 PFS proposed rule and this CY 2025 PFS final rule, this
limits payment for Medicare telehealth services to those services that
are, in whole or in part, inherently a face-to-face service. Because
these services are not inherently face-to-face services, and the
patient need not be present for the services to be furnished in its
entirety, 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 proposed to not add these services to
the Medicare Telehealth Services List.
We did not receive public comments on this proposal and are
finalizing as proposed.
(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 of the elements of the service as described by the
HCPCS code and determining 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. Therefore, we proposed to not add the service to the
Medicare Telehealth Services List because we did not believe the
service elements can be could in full using two-way audio-video
telecommunications technology.
We received public comments on this proposal. The following is a
summary of the comments we received and our responses.
Comment: One commenter recommended that we add this service to the
Medicare Telehealth Services List on a permanent basis. This commenter
provided similar information that was provided in the initial
submission about a patch containing a microneedle array that the
patient can apply themselves in support of their argument that the
service can be furnished in full using two-way, audio/video
telecommunications technology.
Response: We thank the commenter for the additional information. We
continue to believe that this service does not meet the requirements to
be added to the Medicare Telehealth Services List because the service
elements cannot be met in full using two-way audio-video
telecommunications technology. While
[[Page 97753]]
we appreciate the additional information regarding the patch, based on
information provided by the RUC as to the typical resource costs
associated with furnishing this procedure and input from our clinical
advisors, there is not sufficient evidence to demonstrate, if the
service was furnished using two-way audio-video telecommunications
technology, that the clinician actions and patient interaction would be
of similar content as an in-person visit. We will continue to evaluate
whether Posterior Tibial Nerve Stimulation for Voiding Dysfunction, if
using the patch discussed by the commenter, is capable of being
delivered via an interactive telecommunication system and encourage
interested parties to continue to engage with us regarding payment for
this service. After consideration of public comments, we are finalizing
as proposed to not add CPT code 64566 to the Medicare Telehealth
Services List.
(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 Services 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. Therefore, we proposed to remove this code from the Medicare
Telehealth Services List, and we solicited comment on these quality of
care concerns.
We received public comments on this proposal. The following is a
summary of the comments we received and our responses.
Comment: Many commenters supported our proposal to remove Radiation
Treatment Management from the Medicare Telehealth Services List. These
commenters cited that the in-person visit portion of this code is
important for high-quality care and patient safety. In addition, they
provided information about the side effects of radiation treatment that
can be impacted by comorbidities or other therapies or treatments.
Many commenters did not support our proposal to remove Radiation
Treatment Management from the Medicare Telehealth Services List. These
commenters stated that there have been no published safety incidents
since this service has been able to be furnished via Medicare
telehealth and that most of the side effects associated with radiation
treatment delivery are minor dermatological issues that can be treated
via audio-video technology. The commenters who did not support our
proposal also provided information about the medical decision-making
that is used when determining if a patient's side effects are
appropriate to be resolved via a telehealth encounter or if an in-
person visit would be more appropriate. Because the in-person visit
portion of this code is conducted weekly, this decision can change
based on whether the patient is experiencing side effects and other
clinical considerations.
Response: We thank commenters for the extensive information
provided both in support of and counter to our proposal for this
service. After reviewing this information, we are compelled by the
points raised by commenters regarding the lack of evidence of adverse
patient safety outcomes and the importance of allowing clinical
judgement in determining whether a patient can be seen via Medicare
telehealth or whether the patient needs to be seen in-person. However,
we recognize the ongoing patient safety concerns and welcome
information regarding any adverse outcomes as it becomes available.
After consideration of public comments, we are not finalizing as
proposed. Instead, we will retain Radiation Treatment Management (CPT
code 77427) on the Medicare Telehealth Services List on a provisional
basis.
(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 proposed to add HCPCS code G0248 to
the Medicare Telehealth Services List with provisional 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 is a 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.
We received public comments on this proposal. The following is a
summary of the comments we received and our responses.
Comment: Many commenters supported adding these services to the
Medicare Telehealth Services List on a provisional basis, and several
recommended that we add these services to the Medicare Telehealth
Services List on a permanent basis. Many commenters suggested that, as
home INR services are primarily furnished by IDTFs, we should clarify
that these suppliers are also able bill for Medicare Telehealth
services. As these commenters explained in detail, the interaction with
the patient described by this service is generally delivered by
individuals considered to be clinical staff and not practitioners under
the PFS and that studies have indicated positive outcomes when this
clinical staff-provided service is delivered virtually, as it commonly
has been since the first part of 2020.
Response: We thank commenters for their input. After reviewing the
comments information provided by commenters regarding the entities who
commonly bill for these services and the how they are currently
delivered, we believe we need additional time to consider whether these
services should be added to the formal list of Medicare telehealth
services. Therefore, we are not finalizing addition to the Medicare
telehealth list for CY 2025 and welcome input from interested parties
which we may consider for future rulemaking. We note that we believe
continued access to this service is important and not adding this
service to the telehealth list at this
[[Page 97754]]
time does not mean that suppliers should change their current
practices.
After consideration of public comments, we are not finalizing as
proposed to add Home INR Monitoring (HCPCS code G0248) to the Medicare
Telehealth Services List on a provisional basis.
(10) Caregiver Training
We received a request to permanently add Caregiver Training
services, as described by CPT 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 proposed 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 describe new services that were added to the PFS beginning in
2024. Contingent upon finalizing the service code descriptions that we
proposed in section II.E. of this final rule, we also proposed that
HCPCS codes G0541-G0543 (GCTD1-3) and G0539-G0540 (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, audio-video interactive communications technology. Given the
limited utilization of those codes for 2024, there are not 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 this service is
furnished via telehealth for CMS to consider when evaluating these
services for potential permanent addition to the Medicare Telehealth
Services List.
We received public comments on this proposal. The following is a
summary of the comments we received and our responses.
Comment: Many commenters supported adding these services to the
Medicare Telehealth Services List on a provisional basis. Some
commenters recommended that we add these services to the Medicare
Telehealth Services List on a permanent basis.
Response: We thank commenters for their support and may consider
designating these services with permanent status on the Medicare
Telehealth Services List in the future after additional data is
provided in support of these services being furnished via telehealth.
After consideration of public comments, we are finalizing as
proposed to add caregiver training services (CPT codes 97550, 97551,
97552, 96202, 96203 and HCPCS codes G0541-G0543 (GCTD1-3) and G0539-
G0540 (GCTB1-2)) to the Medicare Telehealth Services list for CY 2025
on a provisional basis.
c. Other Services Proposed for Addition to the Medicare Telehealth
Services List
(1) Preexposure Prophylaxis (PrEP) of Human Immunodeficiency Virus
(HIV)
As outlined in Section II.E. of this final rule, we proposed
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 Services List is one of our
criteria for permanent addition, we proposed to add HCPCS codes G0011
and G0013 to the Medicare Telehealth Services List with a permanent
status.
We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: Many commenters supported this proposal, and we did not
receive any comments that were not in support of our proposal.
Response: We thank commenters for their input. After consideration
of public comments, we are finalizing as proposed to add HCPCS codes
G0011 and G0013 to the Medicare Telehealth Services List with a
permanent status on the Medicare Telehealth Services List, beginning in
CY 2025.
(2) Other Consideration for Medicare Telehealth Services List
Comment: Many commenters requested that we add services to the
Medicare Telehealth Services List for which we did not receive requests
through the annual submissions for consideration for the CY 2025
rulemaking cycle and that we did not discuss in the CY 2025 PFS
proposed rule.
Response: We consider requests to add or remove services from the
Medicare Telehealth Services List through the process we established as
required under section 1834(m)(4)(F)(ii). Requests can be submitted to
the CMS Telehealth Review Process mailbox
([email protected]) no later than February 10,
2025, to be considered for the CY 2026 cycle of annual notice and
comment rulemaking. For more information on requesting additions to the
Medicare Telehealth Services List, please see https://www.cms.gov/medicare/coverage/telehealth/request-addition.
Comment: Some commenters requested clarification that the services
designated as ``provisional'' on the Medicare Telehealth Services List
will remain on the list for CY 2025.
Response: As explained previously, we are not considering in this
[[Page 97755]]
rulemaking for CY 2025 whether to recategorize provisional codes as
permanent because we intend to conduct a comprehensive analysis of all
such provisional codes, which we expect to address in future
rulemaking. Except as specifically stated otherwise in this section,
services included on the Medicare Telehealth Services List with
provisional status will remain on the list for CY 2025.
The services that we are adding to the Medicare Telehealth Services
List are listed in Table 12.
BILLING CODE 4120-01-P
[[Page 97756]]
[GRAPHIC] [TIFF OMITTED] TR09DE24.014
[[Page 97757]]
[GRAPHIC] [TIFF OMITTED] TR09DE24.015
[[Page 97758]]
[GRAPHIC] [TIFF OMITTED] TR09DE24.016
BILLING CODE 4120-01-C
We also point commenters to section II.I. of this final rule where
we address requests from commenters to add HCPCS code G0560 to the
Medicare Telehealth Services List. We are finalizing addition of HCPCS
code G0560 to the Medicare Telehealth Services List.
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 three 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),
[[Page 97759]]
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.)
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 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 paid 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 would 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 on a permanent basis.
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, if the
frequency limits were in place, they would be 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.
We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: Many commenters supported our proposals to continue to
suspend application of telehealth frequency limits on subsequent
[[Page 97760]]
inpatient and nursing facility visits and critical care consultations
through 2025. Commenters stated that they appreciated the continued
flexibility while also acknowledging the concerns we expressed
regarding the necessity of in-person care for patients in higher-acuity
settings of care. Several commenters did suggest that we should
permanently lift these restrictions, stating that this flexibility is
helpful in addressing staffing shortages and that we should defer to
individual clinical judgement when it comes to how frequently a patient
requires in-person, non-telehealth care. A few commenters cautioned
that we should not remove frequency limitations permanently, stating
in-person care is essential to quality of life and care due to the
complex nature and acuity of patients in these settings.
Response: We thank commenters for their input. We believe that
continuing to suspend these frequency limitations on a temporary basis
for CY 2025 will allow us more time to evaluate patient safety while
preserving access in a way that is not disruptive to practice patterns
that were established during and after the PHE. We appreciate the
information regarding both patient safety concerns and concerns
regarding supporting healthcare access. We expect to address these
concerns in future rulemaking.
After consideration of public comments, we are finalizing as
proposed to continue suspension of the telehealth frequency limits on
subsequent inpatient and nursing facility visits and critical care
consultations through CY 2025.
e. Audio-Only Communication Technology To Meet the Definition of
``Telecommunications System''
In 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 proposed in the CY 2025 PFS proposed rule 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). Practitioners have the option to use the
``FQ'' or the ``93'' modifiers or both where appropriate and true,
since they are identical in meaning.
We received public comments on this proposal. The following is a
summary of the comments we received and our responses.
Comment: Many commenters supported our proposal, stating that
allowing audio-only communications technology to meet the definition of
telecommunications system when a beneficiary is in their home and does
not have access to, or does not wish to use, two-way, audio/video would
improve access to care, particularly for rural and underserved
populations.
Response: We thank commenters for their support.
[[Page 97761]]
Comment: A few commenters requested the removal of the requirement
that the distant site practitioner be able to furnish Medicare
telehealth services via two-way, audio/video technology. Commenters
pointed out that there are circumstances where the practitioner might
also be in a rural area or area without sufficient broadband
infrastructure that might inhibit their capacity to furnish two-way,
audio-video interactions. Other commenters recommended that we remove
the requirement that audio-only only meet the definition of
telecommunications system when the beneficiary is in their home,
instead requesting that this flexibility be extended to all originating
sites. We also received a few comments expressing reservation with the
use of audio-only communication technology in furnishing Medicare
telehealth services, stating that audio-only services are not analogous
to in-person care and should not be a substitute for face-to-face
encounters.
Response: We appreciate the commenters' views and concerns. As
explained previously, Medicare telehealth services serve as a
substitute for a service that is typically delivered through an in-
person, face-to-face visit with the patient and practitioner. Medicare
telehealth services are generally analogous to, and must include the
elements of, the in-person service. We continue to believe that the use
of two-way, real-time audio/video communications technology to furnish
Medicare telehealth services is the closest approximation to an in-
person service, and is an appropriate general expectation when
furnishing a Medicare telehealth service. Therefore, we are maintaining
the general definition of interactive telecommunications system in
Sec. 410.78(a)(3) for purposes of Medicare telehealth services to mean
multimedia communications equipment that includes, at minimum, audio
and video equipment permitting two-way, real-time interactive
communication between the patient and the distant site physician or
practitioner. We are also maintaining the requirement that distant site
physicians and practitioners must have the technical capability to use
an interactive telecommunications system that includes two-way, real-
time, interactive audio and video communications at the time that an
audio-only telehealth service is furnished.
We proposed in the CY 2025 PFS proposed rule to revise our
definition of interactive telecommunications system in Sec.
410.78(a)(3) to include two-way, real-time audio-only communication
technology under certain circumstances for any telehealth service
furnished to a beneficiary in their home (when the home is a
permissible originating site for the telehealth service). We limited
our proposal to permit Medicare telehealth services to be furnished
using real-time audio-only technology only in the narrow circumstances
that the service is furnished to a patient in their home, and the
patient is either not capable or does not consent to use video
technology. The purpose of our proposal was to recognize that, while
real-time interactive audio-video remains the generally applicable
standard, including for distant site practitioners who wish to furnish
these services, there are special considerations for patients when a
Medicare telehealth service is delivered in their home. For example, a
patient may not have sufficient (or any) access to broadband to support
the use of real-time video technology, may not have the technical
proficiency or support in place to use video technology, or may have
privacy concerns about using video technology for Medicare telehealth
services in their home.
Patients may not wish to use video in their homes because they do
not want the practitioner to view their private, personal living space.
If the patient perceives the use of real-time video technology as
intrusive, the requirement to use video technology without exception
could discourage patients from accessing appropriate health care
services through telehealth. We also recognize that a policy to address
these special considerations can facilitate access to care that would
be unlikely to otherwise occur, given the patient's technological
limitations, abilities, or personal preferences. To reflect this
limited exception to address the unique considerations of patients who
may receive Medicare telehealth services in their homes, as stated in
the CY 2025 PFS proposed rule, we proposed a policy that would permit a
patient-driven choice to use audio-only technology to receive a
Medicare telehealth service based on their technological capabilities
and limitations, and their comfort level with the use of video
technology in their home.
Separately, based on our review of the comments and our own
independent analysis, we do not believe it would be appropriate at this
time to permit two-way, real-time audio-only communication technology
for telehealth services furnished at originating sites other than the
patient's home. As we stated in the CY 2025 PFS proposed rule, all
other originating sites are medical facilities that would generally
have the infrastructure and broadband capacity to support two-way,
audio/video communication technology. Additionally, patients would not
have the same heightened expectation of privacy when video is used for
a Medicare telehealth service in a medical facility as they would in
their home.
We also note that practitioners should always use their clinical
judgment in deciding to furnish services via telehealth, including in
the patient's home, to ensure that appropriate care is being delivered;
including scheduling in-person care as needed.
After consideration of public comments, we are finalizing as
proposed to revise our regulations at Sec. 410.78(a)(3) to permanently
change the regulatory definition of an interactive telecommunications
system to include two-way, real-time audio-only communication
technology for any telehealth services furnished to beneficiaries in
their homes if the distant site physician or practitioner is
technically capable of using an interactive telecommunications system
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, but the patient is not capable
of, or does not consent to, the use of video technology. We clarify
that no additional documentation, except for the appropriate modifier
as mentioned above, are needed.
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
[[Page 97762]]
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. Therefore, we proposed in the
CY 2025 PFS proposed rule that through CY 2025 we would 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.
We received public comments on this proposal. The following is a
summary of the comments we received and our responses.
Comment: Many commenters supported our proposal to continue to
permit the distant site practitioner to use their currently enrolled
practice location instead of their home address when providing
telehealth services from their home through CY 2025. We also received
comments requesting that we make this extension or a similar policy
permanent. These commenters highlighted the need for a permanent
solution for practitioners who do not have an in-person practice
location. Other commenters requested clarification regarding whether
the practitioner's home address could be across a state line from the
location of the beneficiary provided that the practitioner is licensed
in both states.
Response: We thank commenters for their input and may continue to
consider the issues raised in future rulemaking. We remind interested
parties that we defer to state law regarding licensure requirements for
distant site Medicare telehealth practitioners. In addition, we note
that a separate Medicare enrollment is required for each state in which
the practitioner furnishes and intends to bill for covered Medicare
services.
After consideration of public comments, we are finalizing as
proposed that, through CY 2025, we continue to permit the distant site
practitioner to use their currently enrolled practice location instead
of their home address when providing Medicare 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.
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
[[Page 97763]]
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 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 proposed in the CY 2025 PFS proposed rule to extend this flexibility
for all services on a temporary basis only. Specifically, we proposed
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) includes virtual presence through audio/video real-time
communications technology (excluding audio-only).
We received public comments on this proposal. The following is a
summary of the comments we received and our responses.
Comment: The majority of commenters supported extending this
flexibility on a temporary basis for an additional year, although most
requested that we make this flexibility permanent. A few commenters
informed us of potential patient safety concerns and barriers to
billing that we should consider before further extending or making this
flexibility permanent. Some commenters opposed making this flexibility
permanent due to concerns about increasing the amount of physician
``incident to'' billing for services provided by physician assistants
and nurse practitioners, which would obscure the extent to which
physician assistants and nurse practitioners are actually performing
the services.
Response: We appreciate the support of commenters and look forward
to reviewing the information provided as we consider the most
appropriate way to balance patient safety concerns with the interest of
supporting access that we may address in future rulemaking. After
consideration of public comments, we are finalizing as proposed, 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, and finalizing corresponding revisions to our
regulations at Sec. 410.32(b)(3)(ii).
(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 that are 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 or 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 final 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 proposed in the CY 2025 PFS proposed rule 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
[[Page 97764]]
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 does 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 proposed an incremental approach whereby we would adopt without
any time limitation the definition of direct supervision 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
proposed, as described previously, to continue to define ``immediate
availability'' to include real-time audio and visual interactive
telecommunications technology only through December 31, 2025.
We proposed 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 services described
by CPT code 99211 (office and 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 received public comments on this proposal. The following is a
summary of the comments we received and our responses.
Comment: Commenters generally supported this policy and supported
an incremental approach to making permanent the services that this
definition applies to. Commenters provided additional services for us
to consider adopting permanently as inherently low risk for purposes of
the policy permitting direct supervision through virtual presence, such
as diagnostic tests and behavioral health, dermatology, therapy,
registered dietitian nutritionists, cardiac rehabilitation, and
pulmonary rehabilitation services.
Response: We will consider adding to the services for which direct
supervision can include virtual presence in future rulemaking.
After consideration of public comments, we are finalizing as
proposed and revising our regulations 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. We note that, in instances where a
service on the Medicare telehealth list, is available to beneficiaries
in their homes, and also has the requirement of direct supervision,
that under the applicable definition of direct supervision, the
physician/practitioner is required to be available using both and audio
and video. We note that does not necessarily mean that any interaction
between the patient and the physician/practitioner supervising the
service would require a video component.
(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 referred 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
[[Page 97765]]
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 proposed in
the CY 2025 PFS proposed rule 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
through December 31, 2025, 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 excludes audio-only
technology. The documentation in the medical record would need to
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.
We received public comments on this proposal. The following is a
summary of the comments we received and our responses.
Comment: The majority of commenters supported extending the policy
described in this proposal through CY 2025. However, several commenters
continued to encourage us to establish this policy permanently for in-
person and telehealth services, within or outside of an MSA. Commenters
also reiterated 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, noting that the Accreditation Council for Graduate Medical
Education (ACGME) rules allow teaching physicians to concurrently
monitor patient care through appropriate telecommunication technology
when the teaching physician and/or patient is not physically present
with the resident, in all geographic locations.
Response: We thank commenters for the additional information
provided. We will consider the clinical instances when PFS payment is
appropriate for teaching physicians furnishing services that involve
residents, to ensure the teaching physician has personal oversight and
involvement over the management of the portion of the case for which
the payment is sought in future rulemaking.
After consideration of the public comments, we are finalizing the
policy as proposed, to continue to allow teaching physicians to have a
virtual presence in all teaching settings, but only for services
furnished as a Medicare telehealth service. This will continue to
permit teaching physicians to have a virtual presence during the key
portion of the Medicare telehealth service for which payment is sought,
through audio/video real-time communications technology, for all
residency training locations through December 31, 2025.
(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 six 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
[[Page 97766]]
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 requested 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 were 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 sought comment to help
us consider whether adding certain preventive services or higher level
E/M services to the primary care exception will 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 requested information on
whether the inclusion in the primary care exception of specific higher-
level or preventive services will 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.
We received public comments in response to this request for
information. The following is a summary of the comments we received and
our response.
Comment: Many commenters stated they support permanently expanding
the array of services included under the primary care exception,
specifically to include certain preventive and/or higher level E/M
services. Commenters continued to suggest that this expansion would
support the primary care workforce development, improve patient
continuity of care without compromising patient safety, and increase
the utilization of some high-value services. Some commenters suggested
that additional services should also be considered for inclusion under
the primary care exception, specifically services that are related to
patient continuity and integration of care, such as transitional care
management, advance care planning, and chronic care management
services. Other commenters requested that we consider expanding the
primary care exception and definition of a ``teaching setting'' to
include Rural Health Clinics (RHCs), Federally Qualified Health Centers
(FQHCs) and Teaching Health Centers (THCs) that are reimbursed under
Section 340H of the Public Health Service Act. Currently, the primary
care exception does not apply to these centers, and commenters believe
their inclusion would offer more training opportunities for residents
and align payments for services provided at these centers with those
furnished by residents under Medicare graduate medical education
funding.
Response: We will consider the information provided for future
rulemaking.
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 was 3.6 percent and was
based on the expected historical percentage increase of the 2017-based
MEI. For the final rule, we proposed to update the MEI increase for CY
2025 based on historical data through the second quarter of 2024. The
final CY 2025 MEI update is 3.5 percent. Therefore, for CY 2025, the
payment amount for HCPCS code Q3014 (Telehealth originating site
facility fee) is $31.01. Table 13 shows the Medicare telehealth
originating site facility fee and the corresponding MEI percentage
increase for each applicable time period.
We did not receive public comments on this provision, and
therefore, we are finalizing as proposed.
4. Telehealth Place of Service Code
Comment: While not specifically addressing the proposed policies
set forth in the CY 2025 PFS proposed rule, many commenters asked if
claims for telehealth services billed with POS 10 (telehealth provided
in patient's home) will be paid at the non-facility PFS rate for 2025.
Response: In the CY 2024 PFS final rule (88 FR 78874), we finalized
that beginning in CY 2024, claims for telehealth services billed with
POS 10 (telehealth provided in patient's home) will be paid at the non-
facility PFS rate. This policy, as finalized, was not limited to CY
2024. Claims for telehealth services billed with POS 10 (telehealth
provided in patient's home) will continue to be paid at the non-
facility PFS rate for CY 2025 and beyond.
[[Page 97767]]
[GRAPHIC] [TIFF OMITTED] TR09DE24.017
5. 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 the CY 2025 Hospital
Outpatient Prospective Payment System (OPPS) final rule.
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 final rule, Potentially Misvalued Services under
the PFS. Historically, when we received RUC recommendations, our
process had been to establish interim final RVUs for the potentially
misvalued codes, new codes, and any other codes for which there were
coding changes in the final rule with comment period for a year. Then,
during the 60-day period following the publication of the final rule
with comment period, we accepted public comment about those valuations.
For services furnished during the calendar year following the
publication of interim final rates, we paid for services based upon the
interim final values established in the final rule. In the final rule
with comment period for the subsequent year, we considered and
responded to public comments received on the interim final values, and
typically made any appropriate adjustments and finalized those values.
In the CY 2015 PFS final rule with comment period (79 FR 67547), we
finalized a new process for establishing values for new, revised and
potentially misvalued codes. Under the new process, we include proposed
values for these services in the proposed rule, rather than
establishing them as interim final in the final rule with comment
period. Beginning with the CY 2017 PFS proposed rule (81 FR 46162), the
new process was applicable to all codes, except for new codes that
describe truly new services. For CY 2017, we proposed new values in the
CY 2017 PFS proposed rule for the vast majority of new, revised, and
potentially misvalued codes for which we received complete RUC
recommendations by February 10, 2016. To complete the transition to
this new process, for codes for which we
[[Page 97768]]
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 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
[[Page 97769]]
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-recommended work RVUs with the recommended time
values when the RUC-recommended work RVUs did not appear to account for
significant changes in time.
We received several comments regarding our methodologies for work
valuation in response to the CY 2025 PFS proposed rule and those
comments are summarized below.
Comment: Several commenters disagreed with CMS' reference to older
work time sources and stated that their use led to the proposal of work
RVUs based on flawed assumptions. Commenters stated that codes with
``CMS/Other'' or ``Harvard'' work time sources, used in the original
valuation of certain older services, were not surveyed, and therefore,
were not resource-based. Commenters also stated that it was invalid to
draw comparisons between the current work times and work RVUs of these
services to the newly surveyed work time and work RVUs as recommended
by the RUC.
Response: We agree that it is important to use the recent data
available regarding work times and note that when many years have
passed since work time has been measured, significant discrepancies can
occur. However, we also 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 overestimated, 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. Such an assumption would also
undermine the validity of the allocation of indirect PE RVUs to
physician specialties across the PFS.
Instead, we believe that it is crucial that the code valuation
process take place with the understanding that the existing work times
that have been used in PFS ratesetting are accurate. We recognize that
adjusting work RVUs for changes in time is not always a straightforward
process and that the intensity associated with changes in time is not
necessarily always linear, which is why we apply various methodologies
to identify several potential work values for individual codes.
However, we reiterate that we believe it would be irresponsible to
ignore changes in time based on the best data available, and that we
are statutorily obligated to consider both time and intensity in
establishing work RVUs for PFS services. For additional information
regarding the use of old work time values that were established many
years ago and have not since been reviewed in our methodology, we refer
readers to our discussion of the subject in the CY 2017 PFS final rule
(81 FR 80273 through 80274).
[[Page 97770]]
Comment: Several commenters disagreed with the use of time ratio
methodologies for work valuation. Commenters stated that this use of
time ratios is not a valid methodology for valuation of physician
services. Commenters stated that treating all components of physician
time (preservice, intraservice, postservice and post-operative visits)
as having identical intensity is incorrect, and inconsistently applying
it to only certain services under review creates inherent payment
disparities in a payment system, which is based on relative valuation.
Commenters stated that in many scenarios, CMS selects an arbitrary
combination of inputs to apply rather than seeking a valid clinically
relevant relationship that would preserve relativity. Commenters
suggested that CMS determine the work valuation for each code based not
only on surveyed work times, but also the intensity and complexity of
the service and relativity to other similar services, rather than
basing the work value entirely on time. Commenters recommended that CMS
embrace the clinical input from practicing physicians when valid
surveys were conducted and provide a clinical rationale when proposing
crosswalks for valuation of services.
Response: We disagree and continue to believe that the use of time
ratios is one of several appropriate methods for identifying potential
work RVUs for particular PFS services, particularly when the
alternative values recommended by the RUC and other commenters do not
account for survey information that suggests the amount of time
involved in furnishing the service has changed significantly. We
reiterate that, consistent with the statute, we are required to value
the work RVU based on the relative resources involved in furnishing the
service, which include time and intensity. In accordance with the
statute, we believe that changes in time and intensity must be
accounted for when developing work RVUs. When our review of recommended
values reveals that changes in time are not accounted for in a RUC-
recommended work RVU, the obligation to account for that change when
establishing proposed and final work RVUs remains.
We recognize that it would not be appropriate to develop work RVUs
solely based on time, given that intensity is also an element of work,
but in applying the time ratios, we are using derived intensity
measures based on current work RVUs for individual procedures. We
clarify again that we do not treat all components of physician time as
having identical intensity. If we were to disregard intensity
altogether, the work RVUs for all services would be developed based
solely on time values and that is not the case, as indicated by the
many services that share the same time values but have different work
RVUs. For example, among the codes reviewed in this CY 2025 PFS final
rule, the following all share the same total work time of 30 minutes:
CPT/HCPCS codes 76019 (MR safety implant positioning and/or
immobilization under supervision of physician or other qualified health
care professional, including application of physical protections to
secure implanted medical device from 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), 98005 (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), 98013 (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), 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 G0545 (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). However, these codes had very different
proposed work RVUs of 0.60, 1.30 (ProcStat ``I''), 1.20 (ProcStat
``I''), 0.45, and 0.89, respectively. These examples demonstrate that
we do not value services purely based on work time; instead, we
incorporate time as one of multiple different factors in our review
process. Furthermore, we reiterate that we use time ratios to identify
potentially appropriate work RVUs, and then use other methods
(including estimates of work from CMS medical personnel and crosswalks
to key references or similar codes) to validate these RVUs. For more
details on our methodology for developing work RVUs, we direct readers
to the discussion CY 2017 PFS final rule (81 FR 80272 through 80277).
We also clarify for the commenters that our review process is not
arbitrary in nature. 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).
With regard to the commenter's concerns regarding clinically
relevant relationships, we emphasize that we continue to believe that
the nature of the PFS relative value system is such that all services
are appropriately subject to comparisons to one another. Although codes
that describe clinically similar services are sometimes stronger
comparator codes, we do not agree that codes must share the same site
of service, patient population, or utilization level to serve as an
appropriate crosswalk.
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
[[Page 97771]]
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 17 contains a list of codes and
descriptors for which we proposed 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 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 18 details
our refinements of the RUC's direct PE recommendations at the code-
specific level. In section II.B. of this final 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 final rule, we also note that many of the
refinements listed in Table 18 result in changes under the $0.35
threshold and will 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
[[Page 97772]]
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 final rule, Determination
of Practice Expense Relative Value Units (PE RVUs), for more
information regarding the collaborative work of CMS and the RUC in
improvements in standardizing clinical labor tasks.
(4) Recommended Items That Are Not Direct PE Inputs
In some cases, the PE worksheets included with the RUC's
recommendations include items that are not clinical labor, disposable
supplies, or medical equipment or that cannot be allocated to
individual services or patients. We addressed these kinds of
recommendations in previous rulemaking (78 FR 74242), and we do not use
items included in these recommendations as direct PE inputs in the
calculation of PE RVUs.
(5) New Supply and Equipment Items
The RUC generally recommends the use of supply and equipment items
that already exist in the direct PE input database for new, revised,
and potentially misvalued codes. However, some recommendations include
supply or equipment items that are not currently in the direct PE input
database. In these cases, the RUC has historically recommended that a
new item be created and has facilitated our pricing of that item by
working with the specialty societies to provide us copies of sales
invoices. For CY 2025 we received invoices for several new supply and
equipment items. Tables A-E8 and A-E9 detail the invoices received for
new and existing items in the direct PE database. As discussed in
section II.B. of this final 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 A-E8 and A-E9 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
referred 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
[[Page 97773]]
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 referred 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 proposed 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 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), 92137 (Computerized ophthalmic diagnostic imaging (eg,
optical coherence tomography [OCT]), posterior segment, with
interpretation and report, unilateral or bilateral; retina including
OCT angiography), 93896 (Vasoreactivity study performed with
transcranial Doppler study of intracranial arteries, complete (List
separately in addition to code for primary procedure)), 93897 (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 93898
(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 solicited
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.
We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: Some commenters requested that CMS remove CPT code 92229
from the OPPS cap list because it does not include an associated
professional component (PC) or physician interpretation, and it is
primarily utilized in the physician office setting. Despite CPT codes
92227 (Imaging of retina for detection or monitoring of disease; with
remote clinical staff review and report, unilateral or bilateral),
92228 (Imaging of retina for detection or monitoring of disease; with
remote physician or other qualified health care professional
interpretation and report, unilateral or bilateral), and 92229 all
being in the same family of codes and representing the same imaging
service, only differentiated by the modality of review and
interpretation, commenters stated that CPT code 92229 falls outside the
scope of the definition of ``imaging services'' under the DRA because
it does not include a PC and TC split similar to the imaging
technologies governed by section 5102(b) of the DRA. Commenters stated
that ``the DRA is intended to apply to services typically performed in
the hospitals, but CPT code 92229 is primarily done in the physician
office setting,'' and therefore, commenters asserted that the code
``falls outside the intent of the law'' since CPT code 92229 is almost
exclusively performed in physician office or clinic settings, not in
hospital settings.
Response: We appreciate the commenters' feedback regarding CPT code
92229 and may consider the input for future rulemaking. We are always
looking for ways to improve the accuracy of valuation and payment for
services across settings. We note that the analogous CPT codes 92227
and 92228 are also typically performed in the physician office setting,
at 92.1 percent and 81.5 percent, respectively, according to the RUC
Database, similar to nearly every other ophthalmic code on the OPPS cap
list. In response to the commenters' assertion about the DRA's
application, we note that the amendments made to section 1848(b)(4) of
the Act by section 5102(b)(1) of the DRA do not limit application of
the OPPS cap to services typically performed in hospitals.
Comment: Some commenters expressed concern with the application of
the OPPS cap to CPT code 74263 and stated that it would be a
significant barrier to imaging centers providing this service because
of the payment difference between the PFS payment amount and the OPPS
payment amount, which has an estimated payment of $106.30. Commenters
stated that if it were paid under the PFS without the cap, the
technical component payment is estimated to be $566.22, and that the
cap would likely diminish the benefit of our proposed expanded coverage
for computed tomography colonography (CTC).
Some commenters requested that CMS exempt screening services such
as CTC from the OPPS cap. Commenters stated that the DRA exempts
screening and diagnostic mammography from the OPPS cap and that
exemption likely demonstrates a concern specifically about the impact
of the OPPS cap on screening and diagnostic services. Commenters stated
that, given the prevalence of colon cancer and the
[[Page 97774]]
relatively new availability of colon cancer screening with CTC, it
seems plausible and likely that if the OPPS cap were to be enacted
today, Congress would have exempted additional screening services.
Commenters also stated that, if an exemption is not statutorily
allowed, CMS should assign a higher paying Ambulatory Payment
Classification (APC), specifically APC 5524 Level 4 Imaging without
Contrast that has a proposed 2025 OPPS payment amount of $544.85, which
the commenters state is far more comparable to the resource-based 2024
PFS payment of $566.22.
Response: We appreciate the commenters' feedback regarding the
application of the OPPS cap for CPT code 74263. We note that section
1848(b)(4)(B) of the Act specifically excludes diagnostic and screening
mammography from the description of imaging services that are subject
to the OPPS cap, and we do not have the statutory authority to exclude
other services that are within the scope of the description of imaging
services. We refer readers to the CY 2025 Hospital Outpatient
Prospective Payment System (OPPS) Final Rule that is expected to be
published in the Federal Register for more information regarding the
APC assignment for this code.
We did not receive public comments on the other proposed additions
to the OPPS cap list for CY 2025. After consideration of public
comments, we are finalizing the addition of the services listed above
to the list of codes to which the OPPS cap applies, as proposed.
4. Valuation of Specific Codes for CY 2025
(1) Skin Cell Suspension Autograft (CPT Codes 15011, 15012, 15013,
15014, 15015, 15016, 15017, and 15018)
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
15011 (Harvest of skin for skin cell suspension autograft; first 25 sq
cm or less)) and an add-on code (CPT code 15012 (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 15013 (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 15014 (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 15015 (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 15016 (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 15017 (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 15018 (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 disagreed 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 15011 through
15018, respectively, and proposed 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 noted that our concerns with these CPT codes are expansive.
Firstly, we noted that these CPT codes represent a segmentation of a
single service that is performed sequentially on the same date of
service. We solicited 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 solicited 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 15015 and add-on CPT code 15016. 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 believed 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 15011, 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 15017, 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 noted that the survey median intraservice times for CPT codes
15011 through 15018 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 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
[[Page 97775]]
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\ We stated in the proposed rule that this
correlates to the preparation component of the service described by CPT
codes 15013 and 15014, for which the RUC recommended the survey median
time of 33 and 28 minutes, respectively.
---------------------------------------------------------------------------
\15\ https://www.fda.gov/media/169630/download.
\16\ National Institute for Health and Care Excellence. The
ReCell Spray-On Skin system for treating skin loss, scarring and
depigmentation after burn injury. Medical technologies guidance
[MTG21] [internet]. 2014. [Accessed 16 Nov 2017]. https://www.nice.org.uk/guidance/mtg21/documents/the-recell-sprayon-skin-system-for-treating-skin-loss-scarring-and-depigmentation-after-burn-injury-medical-technology-consultation-document.
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We stated in the proposed rule that 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 15012, 15014, 15016, and 15018 would be billed based
on the typical patient described in the vignettes, we stated in the
proposed rule that 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 15015 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 15011
and 15012 for harvesting, 1 unit of both CPT codes 15013 and 15014 for
preparation, 1 unit of CPT code 15015 for the first 480 sq cm of
application, and 7 units of CPT code 15016 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 15015)
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 15015) totals to 529 minutes. The
intraservice time total alone is nearly 6 and \2/3\ hours.
We noted the RUC recommended that CPT codes 15011 through 15018 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
15016 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
15016 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 15018 due to the coding structure.
We also sought feedback on the recommended global period for CPT
code 15013. 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 15013. This would allow the entire service to run
within a surgical global period.
We noted that we believe contractor-pricing is appropriate for CPT
codes 15011 through 15018 until reconsideration of the coding structure
and re-survey is complete, given the concerning aspects of the CPT
codes. We noted that this service is currently billed for using
contractor-priced CPT code 17999 (Unlisted procedure, skin, mucous
membrane and subcutaneous tissue) and the eight new codes are expected
to be a very low utilization.
We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: Most commenters supported our proposal to contractor price
these codes until reconsideration of the coding structure and re-survey
is complete. In their comment letter, the AMA RUC confirmed that these
codes will be re-reviewed in 2027. One commenter provided additional
information regarding CMS' concerns with the coding structure and
encouraged CMS to finalize the AMA RUC's recommendations instead of
contractor pricing for these codes as interim values, citing the
uncertainty and payment variability that is possible with contractor
pricing. The commenter stated that the manufacturer's information
mentions the minimum amount of time (that is, ``as little as''),
[[Page 97776]]
and a maximum amount of time, potentially up to 60 minutes, to process
a sample. The commenter stated that the time depends on skin thickness
and how long it takes the enzyme to break it down and, depending on
patient circumstances, the potential maximum amount of time to process
a sample is no less relevant than the potential minimum amount of time.
Response: We thank commenters for the additional information they
provided. However, we continue to have concerns about the coding
structure and the valuations for the work and PE of these codes as
described in the proposed rule. We recognize the commenter's citation
of the manufacturer's information regarding minimum and maximum
processing times but reiterate that this just one publicly available
source of information and there are additional sources available. We
also note that we value services based on the typical time for a
service, not the minimum or maximum.
Based on the manufacturer's most recently updated Instructions for
Use for a newly approved FDA device, RECELL GO[supreg], processing
typically takes ``around 35 minutes,'' \17\ and we note that the new
device will likely be considered by CPT and the AMA RUC during the
codes' re-review. Additionally, another study published in the Annals
of Surgery in September 2024 to determine the utility of Autologous
Skin Cell Suspension (ASCS) in closing full-thickness (FT) defects from
injury and infection showed mean size of ASCS application of 636 cm\2\
with a range of 45 to 2212 cm\2\, a mean surface area of the wounds
grafted of 435 cm\2\ with a range of 30 to 1608 cm\2\, and a mean area
of the donor site of 212 cm\2\ with a range of 15 to 804 cm\2\. The
study also showed a mean surgical time of 71 minutes and total
operating room time of 124 minutes using the RECELL[supreg] System.\18\
Additionally, an interview of a physician about their clinical
experience using RECELL[supreg] was recently published in the Wound
Care Learning Network \19\ that supports our concerns about the survey
times. We note that this is only three additional sources that have
become available since the proposed rule was published, therefore we
continue to have concerns about the service times, segmentation of the
coding, and billing patterns of the add-on codes based on the
vignettes. After consideration of public comments, we are finalizing
contractor pricing as proposed and look forward to reviewing these
codes again after reconsideration of the coding structure and re-survey
is complete. We encourage the consideration of the many publicly
available sources of information when considering the base and add-on
code structure of this family, and the time it takes to perform these
services.
---------------------------------------------------------------------------
\17\ https://avitamedical.com/instructions-for-use/.
\18\ Hultman, C. Scott MD, MBA*; Adams, Ursula C. MD,
MBA[dagger]; Rogers, Corianne D. MD*; Pillai, Minakshi MS[dagger];
Brown, Samantha T. PA-C*; McGroarty, Carrie Ann PA-C*; McMoon,
Michelle PA-C, Ph.D.*; Uberti, M. Georgina MD[Dagger]. Benefits of
Aerosolized, Point-of-care, Autologous Skin Cell Suspension (ASCS)
for the Closure of Full-thickness Wounds From Thermal and Nonthermal
Causes: Learning Curves From the First 50 Consecutive Cases at an
Urban, Level 1 Trauma Center. Annals of Surgery 280(3):p 452-462,
September 2024. [verbar] DOI: 10.1097/SLA.0000000000006387.
\19\ https://www.hmpgloballearningnetwork.com/site/woundcare/videos/recellr-spray-ontm-skin-cells-innovation-closure-full-thickness-wounds.
---------------------------------------------------------------------------
(2) Hand, Wrist, & Forearm Repair & Recon (CPT Codes 25310, 25447,
25448, 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 25448) 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 disagreed 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 instead proposed 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 did
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 stated that we believed 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
recognized that the total time for CPT code 25310 was 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 stated 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 noted that
the intensity of CPT code 25310 was decreasing, not increasing, as
recommended by the RUC which further suggested that a work RVU of 9.50
would not be appropriate for this code given the surveyed work times.
We disagreed with the RUC-recommended work RVU of 11.14 for CPT
code 25447 (Arthroplasty, intercarpal or carpometacarpal joints;
interposition (eg, tendon)) and we instead proposed 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 disagreed 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 noted 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 disagreed with the RUC-recommended work RVU of 13.90 for CPT
code 25448 (Arthroplasty, intercarpal or carpometacarpal joints;
suspension, including transfer or transplant of tendon, with
interposition, when performed) and we instead proposed a work RVU of
11.85 based on the survey 25th percentile result. We
[[Page 97777]]
noted that the RUC typically values new codes such as CPT code 25448
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 25448 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 25448 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 25448.
We disagreed 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 instead proposed 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 noted 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 proposed the RUC-recommended direct PE inputs for all four codes
in the family without refinement.
Comment: Several commenters disagreed with the CMS proposed work
RVU of 9.00 for CPT code 25310 and stated that CMS should instead
finalize the RUC-recommended work RVU of 9.50. Commenters stated that
the RUC's recommendation of the survey median work RVU of 9.50 more
accurately described the physician work involved in furnishing this
service. Commenters stated that the decrease in intensity of CPT code
25310 could be inferred from referencing the intraservice work per unit
of time (IWPUT) formula, however commenters stated that the change
could be attributed to an artifact of adding 38 minutes of
postoperative visit time and increasing the level of the postoperative
visits to the IWPUT formula, not due to an actual change in the
intensity of performing the procedure itself. Commenters stated that
the RUC provided compelling evidence that changes in time and
technology during the postoperative period have increased the physician
work of CPT code 25310 and that the change in total work for CPT code
25310 is driven by a change in the intensity of the postoperative work.
Commenters emphasized that the increase in postoperative work for CPT
code 25310 adds significantly to the current work RVU of this service.
Commenters compared CPT code 25310 to reference CPT codes 26356 (Repair
or advancement, flexor tendon, in zone 2 digital flexor tendon sheath
(eg, no man's land); primary, without free graft, each tendon) and
66184 (Revision of aqueous shunt to extraocular equatorial plate
reservoir; without graft), and stated that these reference codes
supported the RUC's recommended work RVU of 9.50. Commenters also
stated that the proposed work RVU of 9.00 for CPT code 25310 does not
consider the intensity relativity of the RUC recommended work RVU of
9.50 to many other codes on the PFS and that finalizing this work RVU
would create a rank order anomaly in terms of intensity. The commenters
urged CMS to finalize the RUC's recommended work RVU of 9.50 for CPT
code 25310.
Response: We disagree with the commenters and continue to believe
that the proposed work RVU of 9.00 is a more accurate choice for CPT
code 25310. We disagree with the statement from the commenters that the
decrease in intensity for CPT code 25310 at the RUC's recommended work
RVU of 9.50 is merely an ``artifact'' of adding 38 minutes of
postoperative visit time and increasing the level of the postoperative
visits. We have frequently been informed by the RUC and other
interested parties that services with 10 and 90 day global periods must
be evaluated in their entirety as part of magnitude estimation, and
that it would be inappropriate to consider the postoperative visits as
distinct from the rest of the procedure. We do not agree that the RUC's
recommendation of increased postoperative visits for CPT code 25310 can
be ignored when discussing the intensity of the procedure; as we stated
in the proposed rule, the RUC recommended a decrease in intensity for
this code which we believe better supports our proposed work RVU of
9.00. We do concur with the commenters that that changes in time and
technology of the postoperative period have increased the physician
work of CPT code 25310, which is why we proposed a work RVU of 9.00 as
compared with the current work RVU of 8.08. The recommended work time
in the service period for CPT code 25310 is decreasing relative to the
current work time, which would not justify the work RVU increase that
we proposed; we believe that the proposed work RVU increase from 8.08
to 9.00 accounts for this increase in the work carried out during the
postoperative period.
We disagree with the commenters that reference CPT code 26356's
work RVU of 9.56 justifies the recommended work RVU of 9.50 for CPT
code 25310. While the two codes have similar work time values, CPT code
26356 has additional preservice and immediate postservice work time as
compared with CPT code 25310. The RUC's recommendations also previously
stated that CPT code 26356 is a more intensive service than CPT code
25310 which we believe supports proposing a lower work RVU for CPT code
25310. We also disagree with the commenters that the proposed work RVU
of 9.00 for CPT code 25310 creates a rank order anomaly in terms of
intensity. While it is true that the intensity for this code sits
towards the lower end of the spectrum amongst 90 day global procedures
with similar work time values, there are other CPT codes in this range
with lower intensity values
[[Page 97778]]
such as CPT code 25116 (Radical excision of bursa, synovia of wrist, or
forearm tendon sheaths (eg, tenosynovitis, fungus, Tbc, or other
granulomas, rheumatoid arthritis); extensors, with or without
transposition of dorsal retinaculum) and 28485 (e). As such, CPT code
25310 would not create a rank order anomaly in terms of intensity.
Furthermore, our proposed work RVU of 9.00 falls very much within the
middle range of comparative work RVUs amongst 90 day global procedures
with similar work time values. We note as well that commenters did not
address our analysis of work time changes for CPT code 25310 discussed
in the proposed rule: that the total time is increasing from 235
minutes to 263 minutes (an increase of 12 percent) which does not match
the increase in the recommended work RVU, which is increasing from 8.08
to 9.50 (approximately 18 percent). We continue to believe that our
proposal of the survey 25th percentile work RVU of 9.00 for CPT code
25310 is more accurate, which matches this increase in the total work
time.
Comment: Several commenters disagreed with the CMS proposed work
RVU of 10.50 for CPT code 25447 and stated that CMS should instead
finalize the RUC-recommended work RVU of 11.14, which is the current
work RVU for the service. Commenters stated that CPT code 25447 was
last surveyed in 2005, and the specialties attested that the technique
is the same, but physicians are now more familiar with the procedure
and thus it may be performed in less work time. Commenters stated that
the changes to the work and time of the postoperative care for CPT code
25447, along with higher surveyed preservice and immediate postservice
time not recognized in 2005, offset the decrease in surveyed
intraservice time. Commenters disagreed that there was a reduction in
intensity for this code and stated that CMS' assumption of decreased
intensity was mistaken; commenters stated that by maintaining the
current work RVU of 11.14, the total global work and intraoperative
intensity for CPT code 25447 would not change. Commenters referred to
the top reference codes from the RUC survey and urged CMS to finalize
the RUC's recommended work RVU of 11.14 for CPT code 25447.
Response: We disagree with the commenters and continue to believe
that the proposed work RVU of 10.50 is more accurate for CPT code
25447. We disagree in particular with the commenters that by
maintaining the current work RVU of 11.14, the intensity of CPT code
25447 does not change. The RUC survey found that the intraservice work
time required to perform the procedure has decreased significantly,
from 100 minutes previously to 75 minutes under the recent survey. The
total time of the procedure remained essentially unchanged in the
survey, previously 278 minutes and now slightly higher at 281 minutes.
However, work time that was previously allocated to the intraservice
period has now shifted to the preservice period and postoperative
office visits. We do not agree that this represents ``no change'' in
intensity, as additional time spent on preservice evaluation and
postservice E/M visits take place at a lower intensity level than the
intraservice performance of the arthroplasty itself. As we noted in the
proposed rule, there is a sizable decrease in surveyed intraservice
work time (a reduction of approximately 33 percent) for CPT code 25447,
and since the statute requires that valuation should be based on time
and intensity, we believe that this supports the proposed reduction to
a work RVU of 10.50. We do not agree with the commenters that
additional preservice work time and postoperative office visits are
sufficient to offset this large decrease in the surveyed work time of
the intraservice portion of the procedure. We continue to believe that
our proposal of the survey 25th percentile work RVU of 10.50 for CPT
code 25447 is the most accurate value.
Comment: Several commenters disagreed with the CMS proposed work
RVU of 11.85 for CPT code 25448 and stated that CMS should instead
finalize the RUC-recommended work RVU of 13.90. Commenters appreciated
CMS recognizing the survey results but emphasized that the survey
median work RVU of 13.90 was deemed more appropriate by the RUC to
accurately describe the physician work involved in this new service.
Commenters stated that the survey median work RVU of 13.90 supports
relativity within the family and was warranted by the clinical
complexity of the code. Commenters then described the clinical
complexity of CPT code 25448, stating that this code encompasses the
physician work of CPT code 25447 and the additional complex work of
drilling and creating a hole through the base of the first metacarpal
for passage of the radial half of the flexor carpi radialis from the
second metacarpal to the first metacarpal. Commenters stated that this
additional work beyond the work of CPT code 25447 is much more intense,
resulting in a higher recommended value for surveyed code 25448 when
compared with the other codes in the family. Commenters referred to the
top reference codes from the RUC survey, such as CPT code 29298, and
stated that the intensity of CPT code 25448 is not 50 percent of the
intensity of CPT code 29828 as suggested by the CMS proposal.
Commenters urged CMS to finalize the RUC's recommended work RVU of
13.90 for CPT code 25448.
Response: We disagree with the commenters and continue to believe
that the proposed work RVU of 11.85 is more accurate for CPT code
25448. We would like to clarify for the commenters that we understand
the RUC does not always recommend the survey 25th percentile work RVU
for new codes. We noted in the proposed rule that the RUC ``typically''
values new codes such as CPT code 25448 using this survey 25th
percentile work RVU to indicate that the use of the survey median in
this case was unusually higher than most other recommendations for new
codes. We concur with the commenters that CPT code 25448 requires
additional work and has higher complexity than CPT code 25447. This is
why we proposed a work RVU for CPT code 25448 which is 1.35 units
higher than the work RVU for CPT code 25447, 11.85 as compared with
10.50, as well as why we proposed an intensity for CPT code 25448 which
was higher than anything else in this code family. We believe that our
proposed work RVU appropriate captures the increased work and intensity
of CPT code 25448 relative to the other codes in this family.
We also disagree that the work and intensity of reference CPT code
29298 support the RUC's recommendation of a work RVU of 13.90 for CPT
code 25448. As we wrote in the proposed rule, the RUC stated 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. We also question whether CPT code
29298 is the best choice of comparator code in terms of work time with
CPT code 25448; these two codes differ by about 15 percent in terms of
both intraservice work time (90 minutes against 75 minutes) and total
time (296 minutes against (252 minutes). This difference in surveyed
work time makes direct comparisons on work and intensity more
difficult; we believe that CPT code 25448 is more accurately compared
to other 90 day globals with the same 90 minutes of intraservice time
and similar total time. Our proposed work RVU of 11.85 falls very much
in the middle of this group of related
[[Page 97779]]
services, and there are numerous other CPT codes with lower work RVUs
and lower intensities than what we proposed (such as CPT codes 25608,
27339, and 28725). We continue to believe that our proposal of the
survey 25th percentile work RVU of 11.85 for CPT code 25448 is the most
accurate value.
Comment: Several commenters disagreed with the CMS proposed work
RVU of 9.00 for CPT code 26480 and stated that CMS should instead
finalize the RUC-recommended work RVU of 9.50. Commenters appreciated
CMS recognizing the survey results but stated that the survey median
work RVU of 9.50 was deemed more appropriate by the RUC to accurately
describe the physician work involved in this service. Commenters echoed
the earlier discussion of CPT code 25310, stating that global codes are
made up of distinct packages of work and time and that the preservice
and immediate postservice intensities have never been updated to match
the increases over the years for E/M services. Commenters stated that
the overall work per unit of time (WPUT) may be representative of time
for services on a single date of service, but this same measure cannot
be applied to varied services (evaluation, positioning, scrub/dress/
wait, operation, recovery, ICU/hospital/office services) over a 90-day
global period. Commenters stated that the level of visits has changed
as supported by both medical decision-making and total time on the date
of the encounter of CPT code 26480, and that the change in total work
for CPT code 26480 is driven by a change in the intensity of the
postoperative work. Commenters emphasized that the increase in
postoperative work for CPT code 26480 adds significantly to the current
work RVU of this service. Commenters also stated that the proposed work
RVU of 9.00 for CPT code 26480 does not consider the intensity
relativity of the RUC recommended work RVU of 9.50 to many other codes
on the PFS and that finalizing this work RVU would create a rank order
anomaly in terms of intensity. Commenters referred to the top reference
codes from the RUC survey and urged CMS to finalize the RUC's
recommended work RVU of 9.50 for CPT code 26480.
Response: We disagree with the commenters and continue to believe
that the proposed work RVU of 9.00 is more accurate for CPT code 26480.
As we noted in the proposed rule, 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
more accurate in both cases. As such, many of the same comment
responses provided earlier for CPT code 25310 equally apply to CPT code
26480.
We concur with the commenters that the postoperative visits have
changed for CPT code 26480, however we disagree that intensity measures
cannot be applied to varied services over a 90 day period. As we noted
for CPT code 25310 above, we have frequently been informed by the RUC
and other interested parties that services with 10 and 90 day global
periods must be evaluated in their entirety as part of magnitude
estimation, and that it would be inappropriate to consider the
postoperative visits as distinct from the rest of the procedure. We do
concur with the commenters that changes in time and technology of the
postoperative period have increased the physician work of CPT code
26480, which is why we proposed a work RVU of 9.00 as compared with the
current work RVU of 6.90. The recommended work time in the service
period for CPT code 26480 is essentially unchanged relative to the
current work time, which would not justify the work RVU increase that
we proposed; we believe that the proposed work RVU increase from 6.90
to 9.00 accounts for this increase in the work carried out during the
postoperative period.
We also disagree with the commenters that the proposed work RVU of
9.00 for CPT code 26480 creates a rank order anomaly in terms of
intensity. Again, since CPT codes 25310 and 26480 were proposed at the
identical work times and work RVUs, the comparisons with other codes
across the wider PFS are exactly the same. While it is true that the
intensity for these codes sits towards the lower end of the spectrum
amongst 90 day global procedures with similar work time values, there
are other CPT codes in this range with lower intensity values such as
CPT code 25116 (Radical excision of bursa, synovia of wrist, or forearm
tendon sheaths (eg, tenosynovitis, fungus, Tbc, or other granulomas,
rheumatoid arthritis); extensors, with or without transposition of
dorsal retinaculum) and 28485 (Open treatment of metatarsal fracture,
includes internal fixation, when performed, each). As such, CPT code
26480 would not create a rank order anomaly in terms of intensity.
Furthermore, our proposed work RVU of 9.00 falls very much within the
middle range of comparative work RVUs amongst 90 day global procedures
with similar work time values, not anomalously low. We note as well
that commenters did not address our analysis of work time changes for
CPT code 26480 discussed in the proposed rule: that the total time is
increasing from 227 minutes to 263 minutes (an increase of 16 percent)
which does not match the increase in the recommended work RVU, which is
increasing from 6.90 to 9.50 (approximately 38 percent). We continue to
believe that our proposal of the survey 25th percentile work RVU of
9.00 for CPT code 26480 is more accurate, which more closely matches
this increase in the total work time.
After consideration of the comments, we are finalizing the work
RVUs for all four codes in the Hand, Wrist, & Forearm Repair & Recon
family as proposed. We did not receive any comments on the direct PE
inputs and we are also finalizing them as proposed.
(3) CAR-T Therapy Services (CPT Codes 38225, 38226, 38227, and 38228)
In September 2023, the CPT Editorial Panel deleted four category
III codes (0537T-0540T) and approved the addition of four new codes
(38225-38228) 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 38225, 38226, 38227, and 38228 and
only recommended direct PE values for code 38228.
For CPT code 38225 (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 38226 (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 38228 (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 38227 (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 38227, we proposed the RUC-recommended work RVU of
0.80. We proposed the RUC-recommended work RVUs for CPT codes 38225,
38226, and 38228 respectively.
As mentioned previously, the RUC recommended direct PE values for
only one code, CPT code 38228, and the RUC recommended that the non-
facility PE
[[Page 97780]]
RVU for CPT codes 38225-38227 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 38225-
38227 we treated these codes as having no recommended direct PE values
and sought comment on direct PE values for these codes. We proposed the
RUC-recommended direct PE inputs for CPT code 38228.
Comment: The majority of commenters supported our proposal to pay
separately for these services under the PFS. However, some commenters
also highlighted that the existing CAR-T codes, CPT codes 0537T-0539T,
are currently not payable under the OPPS and recommended that CMS
should assign active payment for CAR-T services under the OPPS as well.
Additionally, a few commenters mentioned that currently these services
are not payable under the PFS, and a commenter highlighted the ``N/A''
that is currently listed for non-facility PE RVUs for the current CAR-T
codes (CPT codes 0537T-0539T) under the PFS.
Response: We thank the commenters for their support for our
proposal and recommendation for the OPPS. As the commenters pointed
out, the predecessor codes for CAR-T services (CPT codes 0537T-0539T)
are not separately payable under the OPPS, and we note that these same
codes similarly have a bundled status under the PFS (meaning they are
subsumed within other codes and separate payment is not made for the
services they describe). In the CY 2019 OPPS final rule, we stated that
``the procedures described by CPT codes 0537T, 0538T, and 0539T
describe various steps required to collect and prepare the genetically
modified T-cells, and Medicare does not generally pay separately for
each step used to manufacture a drug or biological'' (83 FR 58905). In
consideration of our current policies under both the PFS and the OPPS
to not pay separately for the predecessor codes (CPT codes 0537T-
0539T), we are not finalizing our proposal and will instead continue to
bundle payment under the PFS for CAR-T services described under CPT
codes 38225, 38226, and 38227. We believe that bundled status is
appropriate for these codes in order to remain in alignment with OPPS
to not pay separately for each step used to manufacture a drug or
biological. We will display the RUC-recommended work RVUs for these
three services, as we do for a number of other bundled services on the
PFS, however they will remain non-payable. CPT code 38228 is the
replacement code for Category III CPT code 0540T, which does not have
bundled status, and therefore, we are finalizing active pricing for CPT
code 38228 at the proposed work RVU of 3.00 and with the proposed
direct PE inputs.
(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 proposed the RUC-recommended direct PE inputs for CPT codes
36514, 36516, and 36522 without refinement. The RUC did not make
recommendations and we did not propose any changes to the work RVU for
CPT codes 36514, 36516, and 36522.
Comment: Commenters agreed with CMS' proposed direct PE inputs for
the Therapeutic Apheresis and Photopheresis code family.
Response: We thank commenters for their support. After
consideration of the public comments, we are finalizing the direct PE
inputs as proposed.
(5) Intra-Abdominal Tumor Excision or Destruction (CPT Codes 49186,
49187, 49188, 49189, and 49190)
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 49186 (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 49187
(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 49188 (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 49189 (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 49190 (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 49186, a work RVU of
28.65 for CPT code 49187, a work RVU of 34.00 for CPT code 49188, a
work RVU of 45.00 for CPT code 49189, and a work RVU of 55.00 for CPT
code 49190.
We proposed the RUC-recommended work RVUs of 22.00 for CPT code
49186, 28.65 for CPT code 49187, and 34.00 for CPT code 49188.
We disagreed with the RUC-recommended work RVU of 45.00 for CPT
code 49189 and we proposed 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 49189 suggested a work RVU of 41.51 and
the total time ratio suggested a work RVU of 38.02. These changes in
surveyed work time as compared with predecessor CPT
[[Page 97781]]
code 49205 suggested that the recommended work RVU of 45.00 was
inappropriately high. We also noted that the RUC recommended the survey
25th percentile work RVU for CPT codes 49186, 49187, and 49188.
Therefore, we believed that proposing a work RVU of 40.00 for CPT code
49189 kept the valuation consistent with the other CPT codes in this
family. Our proposed work RVU of 40.00 for CPT code 49189 was 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, Yacoub
Procedure)) with a work RVU of 60.80 with 300 minutes of intra-service
time and 838 minutes of total time. We believed the proposed work RVU
of 40.00 was 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 disagreed with the RUC-recommended work RVU of 55.00 for CPT
code 49190 and we proposed 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 49190 suggested a work RVU of 48.21 and
the total time ratio suggested a work RVU of 48.86. These changes in
surveyed work time as compared with predecessor CPT code 49205
suggested that the recommended work RVU of 55.00 was inappropriately
high. We also note again that the RUC recommended the survey 25th
percentile work RVU for CPT codes 49186, 49187, and 49188. Therefore,
we believed that proposing a work RVU of 50.00 for CPT code 49190 kept
the valuation consistent with the other CPT codes in this family. Our
proposed work RVU of 50.00 for CPT code 49190 was 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 believed the proposed RVU of 50.00 was 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 noted that the RUC's recommendations for the first three
codes in the family (CPT codes 49186-49188) maintained the same amount
of intensity as their respective predecessor codes, and in fact
slightly decreased in intensity in the case of CPT codes 49186 and
49187. However, the RUC recommended a notable increase in intensity for
CPT codes 49189 and 49190 over predecessor code 49205 due to its
selection of the survey median work RVU in both cases. We did not
believe that this increase in intensity for CPT codes 49189 and 49190
was 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 believed that this intensity argument
further supported our choice to propose the survey 25th percentile work
RVU for these two codes, matching the RUC recommendations for CPT code
49186-49188.
We proposed the RUC-recommended direct PE inputs for CPT codes
49186, 49187, 49188, 49189, and 49190 without refinement.
The following is a summary of the comments we received and our
responses.
Comment: The commenters overwhelmingly supported our proposal to
accept the RUC recommended work RVUs for CPT codes 49186, 49187, and
49188.
Response: We thank the commenters for their support.
Comment: A few commenters disagreed with the proposed work RVUs of
40.00 for CPT code 49189 and 50.00 for CPT code 49190. The commenters
stated that we failed to recognize the increased burden, intensity, and
complexity of removing not just a single tumor, but for multiple tumors
as represented by CPT codes 49189 and 49190. The commenters also stated
that per the RUC's compelling evidence statements it is important to
note that the technical difficulty increases as the tumor size
increases.
Response: We disagree with the commenters and note that by using
the survey 25th percentile for CPT codes 49189 and 49190, we did
propose values with a higher intensity than their predecessor code, CPT
code 49205. Although we agree that the intensity of CPT codes 49189 and
49190 has increased as compared with predecessor CPT code 49205, the
intensity of these new codes is not high enough to support using the
survey median for either of them. The changes in surveyed work time as
compared with predecessor CPT code 49205 suggested that the survey
median work RVUs of 45.00 for CPT code 49189 and 55.00 for CPT code
49190 recommended by the RUC were both inappropriately high. For
example, in reviewing CPT code 49189 we noted that the recommended
intraservice time as compared with predecessor CPT code 49205 was
increasing from 225 minutes to 310 minutes (38 percent), and the
recommended total time was increasing from 645 minutes to 814 minutes
(26 percent); however, the RUC-recommended work RVU was increasing from
30.13 to 45.00, which is an increase of nearly 50 percent. We believe
that since the two components of work are time and intensity, changes
in the work time should be reflected in similar changes to the work
RVU. Our proposal of a work RVU of 40.00 for CPT code 49189, an
increase of approximately 33 percent, better matches these changes in
surveyed work time relative to the predecessor code.
We also noted that the RUC recommended the survey 25th percentile
work RVU for CPT codes 49186, 49187, and 49188 and we believe it would
better support relativity to utilize the same survey 25th percentile
work RVU for the final two codes in the family. Therefore, we continue
to believe that a work RVU of 40.00 for CPT code 49189, and a work RVU
of 50.00 for CPT code 49190, is more appropriate.
Comment: We received comments regarding the reference codes we used
in our proposal for CPT codes 49189 and 49190. The reference codes we
used to support the proposed work RVU of 40.00 for CPT code 49189 were
CPT codes 69970 and 33864, and the reference codes we used in support
of the proposed work RVU of 50.00 for CPT code 49190 were CPT codes
61598 and 47140. For CPT code 49189, the commenters agreed that CPT
code 33864 was an appropriate reference code but disagreed with our use
of CPT code 69970 as the other reference code in support of the
proposed work RVU of 40.00 because it was valued nearly 30 years ago
and it is not clear how the value for this service was established at
that time. Likewise, for CPT code 49190, the commenters agreed that CPT
code 47140 was an appropriate reference code but disagreed with our use
of CPT code 61598 as the other reference code that supported the
proposed work RVU
[[Page 97782]]
of 50.00 because it was valued 30 years ago.
Response: We disagree with the commenters and continue to believe
that the work RVUs of 40.00 for CPT code 49189, and 50.00 for CPT code
49190, both based on the survey 25th percentile for each code, are
appropriate. We note that the reference codes we chose were only used
to show support for using the surveyed 25th percentile values from the
RUC for CPT codes 49189 and 49190, and that we did not propose to
crosswalk the RVUs from any reference codes to CPT code 49189 or CPT
code 49190. Furthermore, we note that the commenters supported our use
of CPT code 47140 as a reference code, even though it was last valued
21 years ago.
After consideration of the public comments, we are finalizing the
work RVU values for the Intra-Abdominal Tumor Excision or Destruction
code family (CPT codes 49186, 49187, 49188, 49189, and 49190) as
proposed. We are also finalizing the direct PE inputs for CPT codes
49186, 49187, 49188, 49189, and 49190 as proposed.
(6) Bladder Neck and Prostate Procedures (CPT Codes 53865 and 53866)
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 53865'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 53865 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 53865.
At the January 2024 RUC meeting, the specialty society indicated
that CPT code 53866'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 53866 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 53866.
We also proposed the RUC-recommended direct PE inputs for CPT codes
53865 and 53866 without refinement. However, we noted possible
duplications in two of the supply items within CPT code 53865.
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 sought 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.
Comment: A commenter stated that they had completed over 150 sales
of the iTind device (SD366), which is included as a direct PE input for
CPT codes 53865 and 53866 at an ASP of $3,150, $3,350, or $3,420. The
commenter requested that CMS increase the supply price for SD366 to its
current sales price of $3,350 and submitted two invoices for use in
updating supply pricing.
Response: We appreciate the submission of these additional invoices
for assistance in pricing the SD366 supply item. After reviewing the
invoices, we are finalizing an increase in the pricing of the SD366
supply from the proposed $2695 to $2972.50. This updated pricing is
based on averaging together the price from all four invoices, two
submitted by the RUC and two submitted by the commenter. We note that
the difference in pricing for the SD366 supply on these invoices
appears to be correlated with the quantity ordered, with a price of
$3350 for the purchase of a single device as opposed to $2695 for
ordering four devices together. We believe that averaging together
these invoices will smooth out these quantity disparities and more
closely reflect the typical market pricing.
(7) MRI-Monitored Transurethral Ultrasound Ablation of Prostate (CPT
Codes 51721, 55881, and 55882)
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 proposed 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 welcomed commenters
to provide additional data that we could consider in the valuation of
the work and direct PE inputs for these CPT codes. We proposed a work
RVU of 4.05 for CPT code 51721 (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 55881 (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 55882 (Ablation of prostate tissue,
transurethral, using thermal ultrasound, including magnetic resonance
imaging guidance for, and monitoring of, tissue ablation; with
insertion of transurethral ultrasound transducer for delivery of the
thermal ultrasound, including suprapubic tube placement and placement
of an endorectal cooling device, when performed). We also proposed the
RUC-recommended direct PE inputs for CPT codes 51721, 55881, and 55882
without refinement.
Comment: Some commenters disagreed with the proposed work RVUs for
all three CPT codes in this family. These commenters reiterated
concerns regarding the experience of the RUC survey respondents,
stating that the intra-service times provided in the RUC survey data
were too low and did not reflect the actual time needed to perform
these very complex and critical procedures. Commenters recommended
intra-service times based on their experience and internal tracking
data. For CPT code 51721, the suggested intra-service times varied from
40 to 101 minutes, as opposed to the RUC-recommended 29 minutes. For
CPT code 55881, the suggested intra-service
[[Page 97783]]
times varied from 140 to 279 minutes, as opposed to the RUC-recommended
120 minutes. For CPT code 55882, the suggested intra-service times
varied from 170 to 317 minutes, as opposed to the RUC-recommended 125
minutes. Due to these increased intra-service times, the commenters
also recommended a revised work RVU of 6.75 for CPT code 51721, 13.13
for CPT code 55881, and 16.20 for CPT code 55882.
Response: We thank commenters for their feedback and the additional
data provided; however, we do not agree with the intra-service times or
work RVUs that commenters recommended for this code family. The values
that commenters provided were mixed, but mostly significantly higher
than the proposed values. We believe that the RUC survey respondents
were familiar with the technology and since these CPT codes were
recently converted from Category III to Category I, the survey results
will be more robust as utilization increases over time. We continue to
believe that the RUC-recommended intra-service times and work RVUs
accurately reflects the time and intensity involved with these
services, as supported by the survey results and reference codes. We
look forward to re-reviewing these CPT codes when they are re-submitted
on the RUC's New Technology list.
Comment: Many commenters were supportive of the proposed work RVUs
and direct PE inputs for this code family. These commenters also
acknowledged concerns from interested parties regarding the survey
respondents' experience and intra-service times, specifically noting
that the RUC process relies upon the clinical expertise of its
multidisciplinary physician representatives and that its members are
impartial and free from the external influences of interested parties.
Additionally, commenters highlighted that they anticipate an initial
low utilization of these services that will increase over time, and
since these codes are on the RUC's New Technology list, they will be
re-reviewed in 3 years.
Response: We thank commenters for their support and additional
information provided.
After consideration of the public comments, we are finalizing the
work RVUs and direct PE inputs for all three codes in the MRI-Monitored
Transurethral Ultrasound Ablation of Prostate family as proposed.
(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 proposed the RUC-
recommended work RVU of 1.20 for CPT code 59200. We also proposed the
RUC-recommended direct PE inputs for CPT code 59200 without
refinements.
Comment: Commenters agreed with CMS' proposed work RVU and direct
PE inputs for this code family.
Response: We thank commenters for their support. After
consideration of the public comments, we are finalizing the work RVU
and direct PE inputs as proposed.
(9) Guided High Intensity Focused Ultrasound (CPT Code 61715)
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 did not propose the RUC-recommended work RVU of 18.95 for CPT
code 61715 and instead proposed a work RVU of 16.60 based on a
crosswalk to CPT code 61626 (Transcatheter permanent occlusion or
embolization (eg, 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 61715 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 proposed the RUC-recommended direct PE inputs for CPT code 61715
without refinement.
Comment: Many commenters disagreed with the CMS proposal of a work
RVU of 16.60 for CPT code 61715. Commenters described the clinical
benefits of CPT code 61715 as a non-invasive, real-time monitored and
controlled acoustic surgery procedure that offers a treatment option
for essential tremor in patients that are not candidates for, or do not
want to undergo, open brain surgery. Commenters stated that this code
is a complex procedure which requires a great deal of training and
experience to develop expertise, and that it can be a lengthy and
intense procedure taking a great deal of time to perform. Commenters
objected to the CMS use of CPT code 61626 as a crosswalk for valuation,
stating that this code was deemed ``Do Not Use to Validate for
Physician Work'' in the RUC database and that the work time in this
code was developed to be used for practice expense purposes only and
has not been validated by the RUC. Commenters also stated that CPT code
61626 has been revised by the CPT Editorial Panel and surveyed by the
RUC for the CPT 2026 cycle and should not be used as crosswalk during
the re-review process.
Commenters disagreed with the other CMS reference codes by stating
that they were less intense/complex to perform compared to CPT code
61715 despite having similar work time values. Commenters maintained
that the two key reference codes from the survey, CPT codes 61736 and
61737, were appropriate comparators and that CPT code 61715 was more
intensive that these survey references, both as indicated by the survey
respondents and due to clinical reasons (due to the need for repeated
neurologic assessments of the awake patients during treatment planning
and delivery and because the
[[Page 97784]]
reference codes involve time for opening/closing that is of lower
intensity than the treatment and not required as part of the work for
the CPT code 61715). Commenters stated that a decline in reimbursement
could adversely affect their ability to provide this vital treatment to
Medicare patients and urged CMS to finalize the RUC's recommended work
RVU of 18.95.
Response: We appreciate the additional discussion of the clinical
nature of CPT code 61715 from the commenters and its intensity relative
to the various reference codes discussed above. After consideration of
the comments, we agree that CPT code 61715 is more accurately valued at
the survey 25th percentile work RVU of 18.95 as recommended by the RUC
based on their description of the complexity inherent to the procedure.
We are finalizing this work RVU of 18.95 along with the proposed direct
PE inputs for CPT code 61715.
(10) Percutaneous Radiofrequency Ablation of Thyroid (CPT Codes 60660
and 60661)
In January 2024, the RUC surveyed codes 60660 (Ablation of 1 or
more thyroid nodule(s), one lobe or the isthmus, percutaneous,
including imaging guidance, radiofrequency) and its respective add-on
code 60661 (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 60660, the RUC recommended a work RVU of 5.75 and we
proposed the RUC-recommended work RVU of 5.75.
For add-on code CPT 60661, the RUC recommended a work RVU of 4.25
and we proposed the RUC-recommended work RVU for this code. We also
proposed the RUC-recommended direct PE values for both codes 60660 and
60661.
Comment: Many commenters supported the CMS proposal of the RUC-
recommended work RVUs for CPT codes 60660 and 60661. These commenters
urged CMS to finalize the values as proposed.
Response: We appreciate the support for our proposed work RVUs from
the commenters.
Comment: Several commenters stated that they supported the proposed
work RVUs for CPT codes 60660 and 60661, however the commenters
expressed significant concerns regarding the reimbursement challenges
faced by endocrinologists in private non-facility-based practices for
the Radiofrequency Ablation (RFA) of thyroid nodules. The commenters
stated that there are critical issues that need to be addressed to
ensure continued access to this important procedure for patients in
need. These issues included the high cost of the RF electrode which
poses a significant financial burden on practices, a reimbursement gap
for endocrinologists in non-facility-based practices, the upfront costs
of RFA equipment and consumables which threaten to impact patient
access to these services, and that there are sustainability concerns
regarding the current reimbursement model for RFA procedures. The
commenters urged CMS to reconsider the reimbursement framework for RFA
procedures, taking into account the full range of practice expenses,
including essential consumables like the RF electrode.
Response: We appreciate the additional information submitted by the
commenters regarding the issues involving reimbursement for these
radiofrequency ablation services. Although this discussion is beyond
the scope of this particular code family, if the commenters believe
that the valuation of the RF electrode (SD368) supply at $1995.00 does
not reflect current market pricing, we would encourage them to submit
invoices via email to the [email protected] inbox as
described in the PE section of this final rule.
After consideration of the comments, we are finalizing the work
RVUs and direct PE inputs for the codes in the Percutaneous
Radiofrequency Ablation of Thyroid family as proposed.
(11) Fascial Plane Blocks (CPT Codes 64466, 64467, 64468, 64469, 64473,
64474, 64486, 64487, 64488, and 64489)
In September 2023, the CPT Editorial Panel created six new Category
I CPT codes, CPT code 64466 (Thoracic fascial plane block, unilateral;
by injection(s), including imaging guidance, when performed), 64467
(Thoracic fascial plane block, unilateral; by continuous infusion(s),
including imaging guidance, when performed), 64468 (Thoracic fascial
plane block, bilateral; by injection(s), including imaging guidance,
when performed), 64469 (Thoracic fascial plane block, bilateral; by
continuous infusion(s), including imaging guidance, when performed),
64473 (Lower extremity fascial plane block, unilateral; by
injection(s), including imaging guidance, when performed), and 64474
(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 proposed the RUC-recommended work RVU for all ten codes in this
family. We proposed a work RVU of 1.50 for CPT code 64466, 1.74 for CPT
code 64467, 1.67 for CPT code 64468, 1.83 for CPT code 64469, 1.34 for
CPT code 64473, 1.67 for CPT code 64474, 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 also proposed the RUC recommended direct PE inputs for CPT codes
64467, 64468, 64469, 64474, 64487, 64488, and 64489. We disagreed with
one of the RUC recommended direct PE inputs for CPT codes 64466, 64473,
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 disagreed with the RUC that there
are rounding errors in these codes and we proposed to maintain the
current 7 minutes of CA019 clinical labor time for CPT codes 64466,
64473, and 64486. We noted 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 proposed a decrease
of 0.5 minutes to the equipment time for the stretcher (EF018) and 3-
channel ECG (EQ011) which decreases from 25.5 to 25 minutes for these
three codes. We proposed all of the other RUC-recommended direct PE
inputs for CPT codes 64466, 64473, and 64486 without refinement.
[[Page 97785]]
Comment: Commenters agreed with CMS' proposed work RVU and direct
PE inputs for this code family.
Response: We thank commenters for their support. After
consideration of the public comments, we are finalizing the work RVU
and direct PE inputs as proposed.
(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 recommended that CMS remove
the supply input SG007 adhesive, skin (Dermabond) and add one unit of
SH076 adhesive, cyanoacrylate (2ml uou). We proposed 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 recommended that CMS
remove the supply input SG007 adhesive, skin (Dermabond) and add one
unit of SH076 adhesive, cyanoacrylate (2ml uou). We proposed the RUC-
recommended direct PE inputs for HCPCS codes G0516-G0518.
Comment: Commenters agreed with CMS' proposed direct PE inputs for
this code family.
Response: We thank commenters for their support. After
consideration of the public comments, we are finalizing the direct PE
inputs as proposed. We did not propose and are not finalizing any
changes to the work RVUs.
(13) Iris Procedures (CPT Codes 66680, 66682, and 66683)
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 66683
(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 66683 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 (eg, McCannel suture)).
We disagreed with the RUC-recommended work RVU of 10.25 for CPT
code 66680. We proposed 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 disagreed with the RUC-recommended work RVU of 10.87 for CPT
code 66682. We proposed 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 code 66683, the RUC
survey 25th percentile result, with an intraservice time of 60 minutes
and a total time of 224 minutes. We disagreed with the RUC-recommended
work RVU of 12.80 for CPT code 66683. Although we disagreed with the
RUC-recommended work RVU, we concurred that the relative difference in
work between CPT codes 66682 and 66683 is equivalent to the recommended
interval of 1.93 RVUs. Therefore, we proposed a work RVU of 10.67 for
CPT code 66683, based on the recommended interval of 1.93 additional
RVUs above our proposed work RVU of 8.74 for CPT code 66682. This 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 work RVU of
10.67, provide additional support for our valuation.
We also disagreed 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
[[Page 97786]]
by more than 50 percent 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 proposed
modest intensity increases for both codes; however, we continue to
disagree that the very substantial intensity increases recommended by
the RUC would be accurate for this code family. We believe that our
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 proposed the direct PE inputs as recommended by the RUC for all
three codes in the family without refinement.
Comment: We received a few comments opposed to our proposal. Of
these commenters, most asserted that CMS should finalize the RUC-
recommended work RVU values for CPT codes 66680 and 66682. Commenters
asserted that the direct work RVU crosswalk that CMS proposed for CPT
code 66680 was inappropriate because assigning a work RVU of 7.97 based
on a crosswalk to CPT code 67904 does not maintain relativity with
other 90-day global intraocular procedures with which CPT code 66680
should be compared. Commenters stated that the procedure described by
CPT code 66680 has a much higher risk and requires greater intensity
than extraocular procedures. They criticized the CMS methodology as
relying too heavily on time and not enough on the overall intensity,
which is higher on account of greater expectations for restoring normal
anatomical relationships. These commenters also stated that the
proposed work RVU of 8.74 for CPT code 66682 does not adequately
account for the increase in intensity and complexity which has occurred
since its prior valuation in 1992. In their public comment, the RUC
objected to the proposed methodology for assigning a work RVU to CPT
code 66682, stating that any mathematical or computational methodology
other than magnitude estimation used to value physician work is
inappropriate, and inconsistent with RBRVS principles.
All commenters urged CMS to finalize the RUC recommended work RVU
value of 12.80 for CPT code 66683. One commenter stated that they
agreed that the relative difference in work between CPT codes 66682 and
66683 is equivalent to the recommended interval of 1.93 RVUs between
CPT codes 66682 and 66683. They felt this interval should be applied to
the RUC-recommended work RVU for CPT code 66682. Another commenter
disagreed, saying that the relative complexity of CPT code 66683 as
compared to CPT code 66682 is significantly greater than the 1.93 work
RVU difference as noted by the RUC and in the proposed work RVUs for
CPT codes 66682 and 66683.
Response: We thank the commenters for their feedback. However, we
disagree with the commenters and are finalizing the work RVUs for CPT
codes 66680, 66682 and 66683 as proposed. We continue to believe that
the use of time ratios is one of several appropriate methods for
identifying potential work RVUs for particular PFS services. We
reiterate that, consistent with the statute, we are required to value
the work RVU based on the relative resources involved in furnishing the
service, which include time and intensity. In accordance with the
statute, we believe that changes in time and intensity must be
accounted for when developing work RVUs. We recognize that it would not
be appropriate to develop work RVUs solely based on time given that
intensity is also an element of work, but in applying the time ratios,
we are using derived intensity measures based on current work RVUs for
individual procedures. When our review of recommended values reveals
that changes in time are not accounted for in a RUC-recommended work
RVU, the obligation to account for that change when establishing
proposed and final work RVUs remains. We reiterate that we use time
ratios to identify potentially appropriate work RVUs, and then use
other methods (including estimates of work from CMS medical personnel
and crosswalks to key reference or similar codes) to validate these
RVUs. For more details on our methodology for developing work RVUs, we
direct readers to the discussion in the CY 2017 PFS final rule (81 FR
80272 through 80277).
We continue to disagree with the RUC and with commenters that the
intensity for CPT code 66680 has more than doubled, given that the code
descriptor remains unchanged and the surveyed intraservice work time is
unchanged at 45 minutes. We also disagree with the RUC and with
commenters that the intensity for CPT code 66682 has increased by more
than 50 percent, given that CPT code 66682 has no change in its code
descriptor and a modest increase in its surveyed work time. We noted in
the proposed rule that we did not believe these substantial increases
in intensity would be typical for these codes, and we did not receive
new information from commenters that supported finalizing work RVUs
that would warrant these intensity increases. We continue to believe
that our proposed valuations, based on a crosswalk for CPT code 66680
and the use of a time ratio for CPT code 66682, more accurately value
these codes since they do not result in the sizable increases in
intensity as recommended by the RUC. We note again for commenters that
the work RVU and the intensity are increasing for both CPT codes 66680
and 66682 at the values we proposed, as we recognize that these
services now require additional work and intensity as compared with the
time of their prior review.
For CPT code 66683, we agreed with commenters and the RUC that this
code has greater intensity than CPT code 66682. Commenters agreed with
our proposal that the relative difference in work between CPT codes
66682 and 66683 is equivalent to the recommended interval of 1.93 RVUs,
only disagreeing on the work RVU of CPT code 66682 itself. We believe
the use of an incremental difference between codes is a valid
methodology for setting values, especially in valuing services within a
family of revised codes where it is important to maintain appropriate
intra-family relativity. Historically, we have frequently utilized an
incremental methodology in which we value a code based upon its
incremental difference between another code or another family of codes.
We note that the RUC has also used the same incremental methodology on
occasion when it was unable to produce valid survey data for a service.
We continue to believe that our proposed work RVU of 10.67 for CPT code
66683 is the most accurate valuation for this code.
With regard to the commenters' concerns regarding clinically
relevant relationships, we emphasize that we continue to believe that
the nature of the PFS relative value system is such that all services
are appropriately subject to comparisons to one another. Although codes
that describe clinically similar services are sometimes stronger
comparator codes, we do not agree that codes must share the same site
of service, patient population, or utilization level to serve as an
appropriate crosswalk. For more details on our methodology for
developing work RVUs, we again direct readers to the discussion in the
CY 2017 PFS final rule (81 FR 80272 through 80277).
After consideration of the comments and as stated above, we are
finalizing the work RVUs for CPT codes 66680, 66682 and 66683 as
proposed. We are also finalizing the direct PE inputs as proposed for
all three codes in the family without refinement.
[[Page 97787]]
(14) Magnetic Resonance Examination Safety Procedures (CPT Codes 76014,
76015, 76016, 76017, 76018, and 76019)
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 76014 (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 76015 (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 76016 (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 76017 (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 76018 (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 76019
(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 76014 and 76015 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 76016, 76017,
76018, and 76019) in this code family.
We proposed the RUC-recommended work RVU of 0.60 for CPT code
76016, the work RVU of 0.76 for CPT code 76017, the work RVU of 0.75
for CPT code 76018, and the work RVU of 0.60 for CPT code 76019.
We proposed the following refinements to the direct PE inputs. For
CPT codes 76014, 76015, 76016, 76018, and 76019, we proposed 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) was a similar clinical labor activity and had 1 minute of
time. We also noted that the Medical Physicist had 1 minute of
recommended clinical labor time for the CA034 activity for CPT code
76017. Therefore, we believed 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 76015, we proposed 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 believed this
clinical labor time should be double the 7 minutes assigned to the
CA021 activity for CPT code 76014. The description for CPT code 76014
is for the ``initial 15 minutes'' and CPT code 76015 is for ``each
additional 30 minutes,'' that is, double the time of CPT code 76014. We
believed that the clinical labor associated with the CA021 activity
should match this pattern in which CPT code 76015 contains double the
time of CPT code 76014. This proposed refinement to the CA021 clinical
labor also resulted in a proposed decrease to the equipment time for
the Technologist PACS workstation (ED050) from 45 minutes to 32
minutes.
For CPT code 76017, the RUC recommended 13 minutes of equipment
time for the Professional PACS Workstation (ED053) listed as a Facility
PE input. We believed this was an unintended technical error and we
proposed to remove this time from the direct PE inputs for CPT code
76017.
For CPT codes 76018 and 76019, we proposed 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)) was being cleaned and not the entire room. We believed
that 1 minute of clinical labor time would be typical for cleaning the
EQ412 equipment. Our proposed clinical labor refinement also resulted
in a proposed decrease to the equipment time for EL008 (room, MR) and
EQ412 by 1 minute for these two codes.
For CPT code 76019, we proposed to remove supply item SL082
(impression material, dental putty (per bite block)). We believed this
was an error since the PE recommendations did not list SL082 as one of
the included supplies for CPT code 76019 and it did not appear as a
supply input for any of the other codes in the family.
The following is a summary of the comments we received and our
responses.
Comment: The commenters overwhelmingly supported our proposal of
the RUC recommended work RVUs for CPT codes 76016, 76017, 76018, and
76019.
Response: We thank the commenters for their support.
Comment: The commenters agreed with the proposed PE refinement to
remove equipment time for the Professional PACS Workstation (ED053) for
CPT code 76017 in the facility setting and agreed this was an
unintended technical error.
[[Page 97788]]
Response: We thank the commenters for their support.
Comment: For CPT codes 76018 and 76019, the commenters agreed with
the proposed PE refinement to remove 1 minute of clinical labor time
from the Clean room/equipment by clinical staff (CA024) task, as well
as the resulting decrease in equipment time for equipment codes EL008
and EQ412.
Response: We thank the commenters for their support.
Comment: We received several comments that disagreed with our
proposal to remove 1 minute of clinical labor time from the Document
procedure (nonPACS) (CA034) task for CPT codes 76014, 76015, 76016,
76018, and 76019. The commenters stated that the RUC recommendation of
2 minutes was necessary by describing the various requirements the MRI
technologist must perform and detailing the evaluation and written
report that is part of the documentation process (for example, evaluate
implant components, special positioning requirements, include clinical
staff records, and implant status post procedure).
Response: We appreciate the submission of this additional
information from the commenters regarding the tasks performed by the
MRI technologist. We agree with the commenters that 2 minutes is
necessary given the technologist must write a detailed report to
include evaluated implant components, MR conditions for the requested
exam, implant programming requirements, special positioning
requirements, acceptable radiofrequency coils, and necessary personnel
for the exam. Also, CPT code 76017 only requires 1 minute for CA034
because the medical physicist typically documents the procedure in
tandem with the performance of the MR procedure and needs less time to
complete documentation upon completion of the procedure. Therefore, we
are finalizing the RUC recommendation of 2 minutes for clinical labor
activity CA034 for CPT codes 76014, 76015, 76016, 76018, and 76019.
Comment: Several commenters disagreed with our proposal to reduce
the clinical labor time for the Perform procedure/service--NOT directly
related to physician work time (CA021) task from 27 to 14 minutes for
CPT code 76015. The commenters stated that there is significantly more
work for the MRI technologist with CPT 76015 compared to parent CPT
code 76014 because the MRI technologist typically has to call the
patient's primary care physician's office to obtain additional
information and detailed history related to the implant, assess an
implant where there may be no implant information readily available in
the medical chart (or the patient does not have any implant
information), and if there have been subsequent revision surgeries to
the original implant.
Response: After reviewing the comments for clinical labor activity
CA021 for CPT code 76015, we believe a 7-minute increase from the
proposed 14 minutes to 21 minutes would be appropriate. We believe that
there may be some duplicative work from parent CPT code 76014 and that
a more appropriate time to accomplish the additional tasks would be 3
times the 7-minute value for CA021 assigned to parent CPT code 76014,
instead of the full 27 minutes recommended by the RUC. Our finalized
clinical labor time of 21 minutes for the CA021 activity for CPT code
76015 also results in an increase in equipment time from the proposed
32 minutes to 39 minutes for equipment code ED050.
Comment: The commenters disagreed with our proposal to remove
supply item SL082 from the direct PE inputs for CPT code 76019 and
stated that a typo occurred in the PE Summary of Recommendation (SOR)
which did not correctly list this supply code as a direct PE input.
Response: We agree with the commenters that supply item SL082
should have been included in the PE SOR. Therefore, we are finalizing
the inclusion of the RUC recommended PE input of supply item SL082 for
CPT code 76019.
After consideration of the public comments for the Magnetic
Resonance Examination Safety Procedures code family (CPT codes 76014,
76015, 76016, 76017, 76018, and 76019), we are finalizing the work RVU
values for CPT codes 76016, 76017, 76018, and 76019 as proposed. For CY
2025, CPT codes 76014 and 76015 are PE only services and have no work
RVUs. We are finalizing the RUC recommended direct PE input of 2
minutes for clinical labor activity CA034 for CPT codes 76014, 76015,
76016, 76018, and 76019. For CPT code 76015, we are finalizing 21
minutes for clinical labor activity CA021 and 39 minutes for equipment
code ED050. For CPT code 76019, we are finalizing the inclusion of the
RUC recommended PE input for supply item SL082. All remaining direct PE
inputs for CPT codes 76014, 76015, 76016, 76017, 76018, and 76019 are
finalized as proposed.
(15) Screening Virtual Colonoscopy (CPT Code 74263)
As outlined in section III.K. of this final rule, we proposed to
exercise our authority at section 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
assigned an active payment status for CPT code 74263 (Computed
tomographic (ct) colonography, screening, including image
postprocessing). We noted that, as proposed previously, the OPPS cap
would apply to this code, and payment for the TC of this service would
be capped at the OPPS payment rate.
Comment: Many commenters supported our proposal to assign active
payment status to align with the expanded coverage proposal for CPT
code 74263 although many also expressed concern with the application of
the OPPS cap, and stated that it would be a significant barrier to
imaging centers providing this service because of the payment
difference between the PFS payment amount and the OPPS payment amount,
which has an estimated payment of $106.30.
Response: We appreciate the commenters' support of the proposal to
assign active payment status to align with the expanded coverage
proposal for CPT code 74263. We direct readers to section III.K. of
this final rule for more information regarding the proposal, including
a summary of comments received, and section II.E.3.b.
7. Procedures Subject to the Multiple Procedure Payment Reduction
(MPPR) and the OPPS Cap of This Final Rule for More Information About
the OPPS Cap
After consideration of the public comments, we are finalizing the
proposal to assign active payment status for CPT code 74263.
(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
(eg, organ)), the entire code family was resurveyed for the September
2023 RUC meeting. We proposed 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 proposed
[[Page 97789]]
the RUC-recommended direct PE inputs for CPT codes 76981, 76982, and
76983 without refinement.
Comment: Commenters were supportive of our proposed RUC-recommended
work RVUs and direct PE inputs for CPT codes 76981, 76982, and 76983.
Response: We appreciate the commenters' support and are finalizing
the RUC-recommended work RVUs and direct PE inputs for CPT codes 76981,
76982, and 76983 as proposed.
(17) CT Guidance Needle Placement (CPT Code 77012)
CPT code 77012 (Computed tomography guidance for needle placement
(eg, 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 proposed the RUC-recommended
work RVU of 1.50 for CPT code 77012.
We proposed 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 (ie, fluoroscopy, ultrasound, or computed
tomography), for percutaneous drainage (eg, 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 proposed
all other RUC-recommended direct PE inputs for CPT code 77012.
Comment: Some commenters disagreed with our proposal to refine the
equipment room time for the CT room (EL007) to maintain the current 9
minutes. Commenters reiterated that they believe the 9-minute
convention only applies to RS&I codes in angiographic rooms, whereas
this service is performed in a CT room. Commenters stated that 35 of
the 38 RS&I codes are performed in the angiographic room, so the 9
minutes allocated is appropriate, and one code, CPT code 76080, is
performed in the fluoroscopy room but is typically billed with CPT code
49424 (Contrast injection for assessment of abscess or cyst via
previously placed drainage catheter or tube (separate procedure)) that
also includes fluoroscopy room time. Commenters stated that the
remaining two codes, CPT codes 77012 and 75989, are performed in the CT
room and should have more than 9 minutes of room time.
Response: 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, especially considering commenters raised
concerns about the equipment time for both CPT codes 77012 and 75989.
Therefore, at this time, we continue to believe that 9 minutes for
EL007 is appropriate for this RS&I code until this group of procedures
can be subject to a more comprehensive review and are finalizing to
maintain the current equipment room time of 9 minutes for EL007 as
proposed. We are also finalizing the RUC-recommended work RVU of 1.50
as proposed.
(18) Telemedicine Evaluation and Management (E/M) Services (CPT Codes
98000, 98001, 98002, 98003, 98004, 98005, 98006, 98007, 98008, 98009,
98010, 98011, 98012, 98013, 98014, 98015, and 98016)
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 98000 (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 98001 (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 98002 (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 98003 (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 98004 (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 98005 (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 98006 (Synchronous audio-
[[Page 97790]]
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 98007 (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 98008
(Synchronous audio-only visit for the evaluation and management of a
new patient, which requires a medically appropriate history and/or
examination, straightforward medical decision making, and more than 10
minutes of medical discussion. When using total time on the date of the
encounter for code selection, 15 minutes must be met or exceeded.));
CPT code 98009 (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 98010 (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 98011 (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 98012 (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 98013
(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 98014 (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 98015 (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 98016 (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 98000, a work RVU
of 1.6 for CPT code 98001, a work RVU of 2.6 for CPT code 98002, a work
RVU of 3.50 for CPT code 98003, a work RVU of 0.70 for CPT code 98004,
a work RVU of 1.30 for CPT code 98005, a work RVU of 1.92 for CPT code
98006, a work RVU of 2.60 for CPT code 98007, a work RVU of 0.90 for
CPT code 98008, a work RVU of 1.60 for CPT code 98009, a work RVU of
2.42 for CPT code 98010, a work RVU of 3.20 for CPT code 98011, a work
RVU of 0.65 for CPT code 98012, a work RVU of 1.20 for CPT code 98013.
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).
[[Page 97791]]
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 98000 to 98007), and eight
codes for synchronous audio-only services (CPT codes 98008 to 98014),
and one code for an asynchronous service (CPT code 98016). 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.
The CPT Editorial Panel also established new CPT code 98016
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 98016 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 98016 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 98016 must involve 5-10 minutes of medical
discussion (and the code descriptor does not include MDM as means of
code selection). CPT code 98016 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 98016 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 98016.
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 referred readers to our discussions in previous
rulemaking, where CMS explains the rationale for this policy (88 FR
78871-78878).
CMS has a longstanding 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
98000-98015 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 14 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 14 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.
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[GRAPHIC] [TIFF OMITTED] TR09DE24.018
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 proposed to assign CPT codes 98000-98015 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 Medicare telehealth services will once
again, in general, be available only to
[[Page 97793]]
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 sought
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 noted that we have developed 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 noted 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 will 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 sought comment on what impact, if any, the
expiration of the current flexibilities will be expected to have on
overall service utilization for CY 2025. We referred readers to section
e. of this final rule for our discussion of budget neutrality
adjustments.
Given the similarity between CPT code 98016 and HCPCS code G2012,
we proposed to accept the RUC-recommended values for CPT code 98016,
and we proposed to delete HCPCS code G2012. For CPT code 98016, we
proposed to accept the RUC- recommended work RVU of 0.30, and proposed
the RUC-recommended direct PE inputs. We noted 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 98016, 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 noted that, similar to our current
policy for payment of HCPCS code G2012, CPT code 98016 will 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.
Comment: Many commenters, including specialty societies
representing primary care and behavioral health practitioners,
supported our proposal and stated that they agreed with CMS'
interpretation of section 1834(m) of the Act. Given the limitations of
the statute, these commenters stated that the office/outpatient E/M
codes currently on the Medicare telehealth services list are sufficient
to describe visits furnished to beneficiaries through
telecommunications technology and that adopting the new telemedicine E/
M codes would create confusion with the existing office/outpatient E/M
codes already on the Medicare telehealth services list.
Other commenters, including the AMA, disagreed with our
interpretation of Medicare telehealth services under section 1834(m) of
the Act and stated that, as these codes describe a service that is
definitionally not furnished in person, they would not be subject to
the statutory restrictions. The AMA provided a detailed rebuttal of our
proposal stating that the valuation of the telemedicine E/M codes
reflects the use of telecommunications technology and as a result they
are not ``coded and paid'' as though the service occurred in person.
Furthermore, these commenters stressed that CMS should use every tool
at its disposal to maintain access to Medicare telehealth services in
the face of the expiration of the statutory flexibilities, and that by
recognizing and making payment for the telemedicine E/M codes, CMS
would preserve access to care for many beneficiaries.
Other commenters encouraged CMS, even if we do not pay separately
for the telemedicine E/M codes, to publish values in our payment files
in case private payors wish to recognize the codes. Lastly, a few
commenters also suggested that it would be helpful to have educational
materials to better inform interested parties on how to bill telehealth
services appropriately.
Response: We thank commenters for their support for our proposal.
We do not find the comments put forth by the AMA and other
commenters who opposed our proposal to be persuasive. They do not
adequately address how or why the services described by the sixteen new
telemedicine E/M codes are distinct from E/M services ordinarily
furnished in person such that they are outside the scope of section
1834(m) of the Act. Except for the service delivery modality, the new
telemedicine E/M codes appear to describe the same services that are
provided in person and billed under the existing office/outpatient E/M
codes (99202-99215) and expressly referenced in section
1834(m)(4)(F)(i) of the Act as telehealth services. Although commenters
suggest that the services described by the two code sets are different
because there are different resources (PE and work) involved in
furnishing them, those differences merely reflect delivery of the
services through different modalities (in person or as telehealth
services). Moreover, under section 1834(m)(2)(A) of the Act, CMS is
required to make payment for Medicare telehealth services, regardless
of the resources involved in furnishing the telehealth service, at ``an
amount equal to the amount that such physician or practitioner would
have been paid under this title had such service been furnished without
the use of a telecommunications system.'' As such, we do not believe
that the differences in the resources involved in furnishing the same
service in-person or via telehealth are a relevant consideration for
purposes of payment for Medicare telehealth services. We are concerned
that were we to accept the position that the new telemedicine E/M codes
are not subject to section 1834(m) of the Act because the codes
describe services that are ``inherently'' not a substitute for an in-
person service, we would circumvent the express requirements of section
1834(m) of the Act simply by creating new parallel codes that describe
the same services when furnished remotely using telecommunications
technology.
We note in response to the comments requesting that CMS display
RVUs for these services, the RVU values for these services are
displayed in Addendum B of the PFS, which is available for download at
https://www.cms.gov/medicare/payment/fee-schedules/physician/federal-regulation-notices. We will also consider issuing additional guidance
and educational materials regarding appropriate billing for
[[Page 97794]]
Medicare telehealth services in the future.
Comment: Commenters were universally supportive of our proposal to
replace HCPCS code G2012 with CPT code 98016.
Response: We thank commenters for their support.
After consideration of the comments, we are finalizing our proposal
to not pay separately for CPT codes 98000, 98001, 98002, 98003, 98004,
98005, 98006, 98007, 98008, 98009, 98010, 98011, 98012, 98013, 98014,
98015, and to pay separately for CPT code 98016 in lieu of HCPCS G2012.
(19) Genetic Counseling Services (CPT Code 96041)
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 96041 (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 will 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 will 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 96041, we proposed 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 96041. Because the PE RVUs will not
display for the code with that assignment and that may impact access to
the service with other payors, we instead proposed bundled status
(Procedure Status ``B'') for CPT code 96041 to maintain the status of
predecessor CPT code 96040, and we sought feedback from interested
parties regarding the appropriate procedure status for this code. CPT
guidelines for CPT code 96041 state that a physician or other qualified
healthcare professional (QHP) who may report evaluation and management
services will not be able to report CPT code 96041. Instead, these
physicians and QHPs will use the appropriate evaluation and management
code.
Comment: A few commenters expressed disappointment that CMS did not
propose to reintegrate the cost of the pedigree software subscription.
As part of their revaluation of this service, the AMA RUC recommended
the removal of the software as equipment based on their interpretation
of CMS guidelines regarding what constitutes as direct versus indirect
PE. Commenters stated that the software is a critical part of genetic
counseling as it both creates the genetic family history and calculates
risk based on validated models. The commenters also stated that cost of
pedigree is very specialized and used exclusively for patient and
family evaluations specific to genetic services and recommended that
CMS consider re-including the cost of pedigree software that was
included in the predecessor code.
Response: We disagree with the commenters that the costs associated
with the pedigree system should be included as a direct PE input. We
continue to believe that both the cloud-based pedigree subscription and
the pedigree software previously included as a direct PE input for CPT
code 96040 constitute forms of indirect PE. We note that there have
been occasions in the past where we have finalized the inclusion of
software as a direct PE expense if it met our criteria as typical and
medically necessary for the service in question and could be
individually allocable to a particular patient for a particular
service, but we believe that the annual licensing requirements and
costs for the cloud-based pedigree subscription are administrative
costs that are not unique to individual procedures. Direct expense
categories include clinical labor, medical supplies, and medical
equipment. Indirect expenses include administrative labor, office
expense, and all other expenses not directly allocable to an individual
service.
Comment: In their comment letter, the AMA RUC reiterated their
request for the establishment of a new clinical labor type for genetic
counseling assistants (GCAs) but supported the crosswalk to Physical
Therapy Assistant (L039B) and agreed that it is an appropriate proxy
for the clinical labor rate per minute. The AMA RUC also supported our
proposal to maintain the Procedure Status ``B'' of its predecessor CPT
code 96040, and thanked CMS for publishing the values for other payors
to be able to utilize. Numerous other commenters also supported the
proposal to assign Procedure Status ``B'' to CPT code 96041.
Response: We appreciate the commenters' support and are finalizing
the RUC-recommended direct PE inputs and Procedure Status ``B'' for CPT
code 96041 as proposed.
(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 proposed 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 also proposed the RUC-recommended
direct PE inputs for CPT code 90480 without refinement.
Comment: Several commenters stated their support for the proposed
work RVU and thanked CMS for proposing the RUC recommendations.
Response: We appreciate the support from the commenters for our
proposals.
Comment: Several commenters requested that CMS consider a longer
phase-in period to implement the RUC-recommended work RVUs for COVID-19
vaccine administration to allow ample time for provider education and
preparation for potential payment reductions. The commenters stated
although CMS is proposing to maintain the $40 administration fee
through the year in which Food and Drug Administration (FDA) rescinds
the Emergency Use Authorization (EUA) Declaration, the commenters
believe that, if it is adopted into the PFS, COVID-19 vaccine
administration reimbursement rates would likely decline for providers
serving patients with Medicaid and commercial insurance coverage. The
commenters requested that CMS not list the RVUs for CPT code 90480 in
the Physician Fee Schedule final rule until the EUA declaration is
rescinded as the policy is counter to population health initiatives and
could result in stakeholder confusion regarding the payment rate
[[Page 97795]]
for this code within the Medicare program versus other markets.
Response: We appreciate the feedback from the commenters and
clarify that payment for CPT code 90480 is already addressed under
previously finalized policies associated with the EUA declaration (see
for example the vaccine pricing section of the CMS website at https://www.cms.gov/medicare/payment/part-b-drugs/vaccine-pricing). We agree
with the commenters that it would avoid potential confusion if we do
not display the RVUs for CPT code 90480 as payment will not be made
using this valuation under the PFS. The proposal to assign separate
pricing under the PFS for CPT code 90480 was an unintended error; we
did not intend any confusion that may have been caused by the
publication of these RVUs in the proposed rule.
After consideration of the comments, we are not finalizing the RUC-
recommended work RVU and direct PE inputs for CPT code 90480 at this
time. We refer readers to our current policies for paying for the
service described by CPT code 90480, available at https://www.cms.gov/medicare/payment/part-b-drugs/vaccine-pricing as well as the discussion
in section III.B of this final rule.
(21) Optical Coherence Tomography (CPT Codes 92132, 92133, 92134, and
92137)
At the February 2023 CPT Editorial Panel meeting, CPT code 92137
(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 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 proposed the RUC-recommended work RVUs for all codes within the
Optical Coherence Tomography code family. We proposed 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
92137. We also proposed the RUC-recommended direct PE inputs for all
four codes in the family.
Comment: Commenters generally agreed with CMS' proposed work RVU
and direct PE inputs. One commenter disagreed with CMS' proposed work
RVUs for CPT codes 92132, 92133, and 92134 and urged CMS to maintain
the current work RVUs for those codes and adopt the RUC-recommended
work RVU for CPT code 92137.
Response: We thank commenters for their support. We also
acknowledge the commenter's request to maintain the current work RVUs
for CPT codes 92132, 92133, and 92134. We disagree with the commenter
and continue to believe that the RUC-recommended work RVUs for these 3
codes, that are cross-walked from other codes with similar intensity
and that align with the surveyed reduction of intraservice times,
appropriately account for the physician work required to perform this
service. After consideration of all comments, we are finalizing the
work RVUs and direct PE inputs as proposed.
(22) Transcranial Doppler Studies (CPT Codes 93886, 93888, 93892,
93893, 93896, 93897, 93898, 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 proposed the RUC-recommended work RVU for all seven codes in the
Transcranial Doppler Studies code family. We proposed 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 93896 (Vasoreactivity study performed
with transcranial Doppler study of intracranial arteries, complete), a
work RVU of 0.73 for CPT code 93897 (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 93898 (Venous-arterial shunt detection with intravenous
microbubble injection performed with transcranial Doppler study of
intracranial arteries, complete). We also proposed 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, 93896, 93897, and 93898. However,
we believe that it would be beneficial for the CPT Editorial Panel to
state more explicitly that CPT code 93897 should not be used in
conjunction with CPT code 93892 and that CPT code 93898 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.
Comment: Several commenters stated their support for the CMS
proposal of the RUC's recommended work RVUs and direct PE inputs for
these seven codes. Commenters also acknowledged the CMS recommendation
to the AMA CPT Editorial Panel to more explicitly state that CPT code
93897 should not be used in conjunction with CPT code 93892 and CPT
code 93898 should not be used in conjunction with 93893. Commenters
stated that they were committed to providing education to their members
on the appropriate use of the revised code set for 2025.
Response: We appreciate the support from the commenters for our
proposals, as well as their recognition on the need for clarification
on the billing of certain add-on codes.
Comment: Several commenters disagreed with the proposal of the
RUC's recommended direct PE inputs, specifically the equipment times
for the vascular ultrasound room (EL016) and
[[Page 97796]]
the technologist PACS workstation (ED050). Commenters stated that the
RUC based its recommendations for the technical component of these
codes on a small sample size survey distributed to selected members of
three societies that are not representative of all transcranial doppler
(TCD) practices. Commenters stated that they conducted a survey of
their TCD-focused membership which found that the RUC--and now CMS--
systematically overcounted time for the PACS workstation and
undercounted time in the ultrasound room. Commenters stated that PAC
workstation and ultrasound exam times can vary widely depending on the
patient and results needing to be reviewed; staffing time and
scheduling are a constant challenge due to these variables. Commenters
urged CMS not to finalize the proposed changes to the TCD base codes
and, at the least, CMS should conduct additional study before making
any changes in light of the commenters' data from practitioners that
frequently perform TCD.
Response: We understand the difficulty of determining accurate
equipment times due to the variation that can take place depending on
the patient and results needing review. For this reason, our PE
methodology bases valuation on the typical case, understanding that
some cases will involve fewer time/resources and other cases will be
more complex and difficult. This is also why we typically use
standardized formulas to calculate equipment times; we believe that the
use of these standardized equipment time formulas allows for greater
transparency and consistency in the assignment of equipment minutes
based on clinical labor times across the wider PFS.
For the specific case of the codes in the TCD Studies family, the
RUC recommended and we proposed equipment times based on these standard
equipment time formulas. We specifically proposed equipment time for
the vascular ultrasound room (EL016) based on the standard for highly
technical equipment. As we have addressed in past rulemaking, we
believe that certain highly technical pieces of equipment and equipment
rooms are less likely to be used during all of the pre-service or post-
service tasks performed by clinical labor on the day of the procedure
(the clinical labor service period) and are typically available for
other patients even when one member of clinical staff may be occupied
with a pre-service or post-service task related to the procedure. Since
the direct PE input database should reflect the typical resource costs
of medical equipment, we believe that the reduced minutes and increased
utilization rate for these highly technical equipment items are
complementary, not contradictory (77 FR 69028).
The surveyed equipment times for the vascular ultrasound room
(EL016) submitted by the commenter are all higher than our proposed
equipment times based on the use of this standard for highly technical
equipment. For example, the survey submitted by the commenter lists 61-
65 minutes of equipment time for CPT code 93886 as opposed to our
proposed 57 minutes. However, the total intraservice clinical labor
time for CPT code 93886 is only 70 minutes which would mean that the
vascular ultrasound room would be in use for nearly the entirety of
this period if we were to use the commenter's equipment time
suggestions. As we discussed above, we believe that many of the
preservice and post-service clinical labor tasks typically take place
outside of resource-intensive equipment rooms to maximize use of
capital-intensive resources since monopolizing the room for fewer
minutes per patient maximizes the availability of the machines. We do
not believe that it would be typical to perform tasks such as Greeting/
gowning the patient (CA009), Obtain vital signs (CA010), or Provide
education/obtain consent (CA011) in the vascular ultrasound room, some
or all of which would need to take if the survey times submitted by the
commenter were to be true. Therefore, we continue to believe that the
RUC's recommended equipment times, based on the use of standardized
equipment time formulas, best reflect the typical case for these
Transcranial Doppler Studies codes.
After consideration of the comments, we are finalizing the work RVU
and direct PE inputs for the CPT codes in the Transcranial Doppler
Studies family as proposed.
(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 proposed 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 will then consider in future
rulemaking. We also proposed the direct PE inputs as recommended by the
RUC for both codes.
Comment: A commenter stated that they supported these changes but
recommended that the RUC conduct a more complete review for these
codes.
Response: We appreciate the support for our proposed valuations
from the commenter.
After consideration of the comments, we are finalizing the work RVU
and direct PE inputs for the CPT codes in the RSV Monoclonal Antibody
Administration family as proposed.
(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 proposed the RUC-recommended work RVU of 6.53 for CPT code 96547
[[Page 97797]]
and the RUC-recommended work RVU of 3.00 for CPT code 96548. The RUC
did not recommend, and we did not propose, any direct PE inputs for the
Hyperthermic Intraperitoneal Chemotherapy codes (CPT codes 96547 and
96548).
Comment: Commenters agreed with CMS' proposed work RVU and direct
PE inputs for this code family.
Response: We thank commenters for their support. After
consideration of the public comments, we are finalizing the work RVU
and direct PE inputs as proposed.
(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
2023 RUC meeting without any revisions to their code descriptors.
We disagreed 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 15, 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] TR09DE24.019
For CPT code 96920, we proposed 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
noted 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 noted our 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 proposed 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 noted that our work RVU of 0.90 for
CPT code 96921 maintains the RUC-
[[Page 97798]]
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 noted that 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 proposed 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 noted 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 work RVU of 1.15 maintains in relationship to the
other codes.
For the direct PE inputs, we proposed to refine the clinical staff
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
noted 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 also
proposed 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 refinement for CA024 to the
standard 3 minutes.
We also disagreed with the RUC-recommended creation of new supply
items for the excimer laser and proposed 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 proposed
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 proposed 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, outlined in detail in section II.B. of
this final 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 sought comment on the difference in direct PE costs
between the purchase and per-use rental of the laser. We noted that
using the equipment cost per minute formula, outlined in detail in
section II.B. of this final 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.
We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: Some commenters disagreed with the proposed work RVUs of
0.83, 0.90, and 1.15 for CPT codes 96920, 96921, and 96922,
respectively, and encouraged CMS to finalize the RUC-recommended work
RVUs of 1.00, 1.07, and 1.32, respectively. Some commenters disagreed
with the crosswalks of CPT code 11104 to CPT code 96920, and CPT code
11301 to CPT code 96921, because the intensity of CPT codes 96920 and
96921 is greater than CPT codes 11104 and 11301 as excimer laser
treatment requires a high amount of skill and precision to ensure that
healthy tissues are not damaged and the procedure causes significant
pain requiring patients to have numbing agents applied to their
lesions. The commenters also stated that the excimer laser treatment
occurs over a large body surface area and is associated with risks,
including burns, swelling, and increased skin sensitivity to light.
Commenters also disagreed with our application of total time ratios
to both the current times and original 2002 intraservice times, the
latter of which the AMA RUC and commenters reiterate
[[Page 97799]]
that the current valuations are based on. Commenters disagreed with the
use of total time ratios to account for changes in time as the
physician times were increased in 2012 without a commensurate work RVU
increase, untethering the current assigned times and work RVUs. In
their comment letter, the AMA RUC stated that RUC recommended
crosswalks already reflected significant decreases from the current
valuations of these codes to reflect the differences in work in
treating different body surface areas for this condition. Further, the
RUC stated in its rationale that there have been multiple reviews of
this code set, and the valuation of the codes is currently based on the
original valuation over two decades ago in 2002, where the time was
lower than the current times, therefore the current work RVUs are based
on the lower 2002 times, not the current times. The AMA RUC reiterated
their support of their recommended work RVU crosswalk of CPT code 96920
to CPT code 20606 with a work RVU of 1.00. For CPT code 96921, the AMA
RUC reiterated their support of an incremental 0.07 work RVU difference
between CPT codes 96920 and 96921 but disagreed with a starting point
of 1.00 work RVUs for CPT code 96920.
Response: We agree that it is important to use the recent data
available regarding work times, and we note that when many years have
passed since work time has been measured, significant discrepancies can
occur. However, we also 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 overestimated, 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. Such an assumption would also
undermine the validity of the allocation of indirect PE RVUs to
physician specialties across the PFS.
Instead, we believe that it is crucial that the code valuation
process take place with the understanding that the existing work times
that have been used in PFS ratesetting are accurate. We recognize that
adjusting work RVUs for changes in time is not always a straightforward
process and that the intensity associated with changes in time is not
necessarily always linear, so we apply various methodologies to
identify several potential work values for individual codes. However,
we reiterate that we believe it would be irresponsible to ignore
changes in time based on the best data available and that we are
statutorily obligated to consider both time and intensity in
establishing work RVUs for PFS services. For additional information
regarding the use of old work time values that were established many
years ago and have not since been reviewed in our methodology, we refer
readers to our discussion of the subject in the CY 2017 PFS final rule
(81 FR 80273 through 80274).
We also continue to believe that the use of time ratios is one of
several appropriate methods for identifying potential work RVUs for
particular PFS services, particularly when the alternative values
recommended by the RUC and other commenters do not account for survey
information that suggests the amount of time involved in furnishing the
service has changed significantly. Consistent with the statute, we are
required to value the work RVU based on the relative resources involved
in furnishing the service, which include time and intensity. In
accordance with the statute, we believe that changes in time and
intensity must be accounted for when developing work RVUs. When our
review of recommended values reveals that changes in time are not
accounted for in a RUC-recommended work RVU, the obligation to account
for that change when establishing proposed and final work RVUs remains.
With regards to the current work RVUs and physician time becoming
untethered, we refer readers back to our intraservice time ratios
between the 2002 times and the RUC-recommended times, which result in
lower work RVUs than our proposed work RVUs. We also reiterate that our
proposed work RVUs maintains the intensity associated with the 2002
review of CPT codes 96920, which commenters and the AMA RUC assert that
the work RVUs are tethered to the 2002 physician times.
With regards to the relativity of intensity and complexity of CPT
codes 96920 compared to CPT code 11104, we continue to believe that the
intensity of the two services are similar. Commenters stated that
excimer laser treatment requires a high amount of skill and precision
to perform to ensure that healthy tissues are not damaged, and the
procedure causes significant pain that requires patients to have
numbing agents applied to their lesions. Similarly, according to CPT
code 11104's vignette and pre-service activities, deeply invasive basal
or squamous cell carcinoma may be involved, therefore requiring similar
skill and precision to perform, and CPT code 11104 involves the
injection of the appropriate local anesthetic at the procedure site.
Similarly, we continue to believe that the intensity of CPT codes
96921 and 11301 are similar because CPT code 11301 requires significant
skill and precision to perform based on the intraservice activities
described and it also involves the injection of anesthetic into both
subcutaneous and dermal compartments to facilitate the appropriate
dermal depth removal.
We have no evidence to indicate that the intensity of CPT codes
96920 and 96921 is increasing to the degree that the AMA RUC
recommended, given how the surveyed work time is substantially
decreasing from both current and 2002 physician times. We also believe
maintaining the intensities associated with the 2002 review for these
codes is more appropriate than the significant intensity increases that
results from the RUC-recommended work RVUs, particularly given the
excimer laser manufacturer's comment stating that there has been no
device or procedural change that would increase the intensity or
decrease the physician times, as the RUC recommended.
Comment: One commenter stated that, although the April 2023
surveyed changes in physician time to perform the procedures resulted
in reduced work RVU recommendations, the way the procedures are
performed today are essentially unchanged from the earlier time study
so reductions in physician time would not be expected, particularly in
the amounts suggested by the surveys. The commenter believes the survey
should be redone, with a population that reflects actual users of the
device because there has been no device or procedural change that
warrants such dramatic changes in treatment time.
Response: We acknowledge the commenter's concerns regarding the
surveyed physician time decreases for CPT codes 96920 through 96922 and
encourage the commenter to coordinate with the RUC to facilitate a
reconsideration of the physician work times if the commenter believes
the physician times reported by the surveys are incorrect.
Comment: The AMA RUC disagreed with our proposal to refine the
clinical staff time for the CA024 activity ``Clean room/equipment by
clinical staff'' to the
[[Page 97800]]
standard and current time of 3 minutes for CPT codes 96920, 96921, and
96922 because a rationale for increasing clinical staff time beyond the
standard 3 minutes for the CA024 activity was absent from the PE
Summary of Recommendations. The AMA RUC stated that, during the laser
treatment, each treatment site is covered with mineral oil to aid in
the transmission of ultraviolet laser light through psoriatic plaques
and the patient is repeatedly repositioned which results in the mineral
oil getting all over the treatment table and often on the floor. The
commenter stated that, after treatment, multiple greasy topical
medications are applied to the treated sites and the standard time for
room and equipment cleaning of 3 minutes is inadequate to properly
clean greasy surfaces. The commenter requested that we refine CA024 for
the three codes to provide an additional 2 minutes that is required for
this vital staff function.
Response: We appreciate the AMA RUC's clarification on the
additional 2 minutes beyond the 3-minute standard for CA024. We note
that we proposed to refine this activity to the standard because a
rationale for increasing clinical staff time beyond the standard 3
minutes for the CA024 activity was absent from the PE Summary of
Recommendations. We agree with the commenter that 5 minutes would be
more appropriate to properly clean multiple greasy surfaces and are
finalizing the RUC-recommended 5 minutes for CA024 for CPT codes 96920,
96921, and 96922. We note that, as a result of changing CA024, we are
finalizing the equipment times of 38, 40, and 46 minutes for the power
table (EF031) and exam light (EQ168) equipment for CPT codes 96920,
96921, and 96922, respectively, to account for the finalized refinement
for CA024 to the RUC-recommended 5 minutes.
Comment: An excimer laser vendor commented that a dermatology
office would need to perform at least 1,150 excimer laser procedures a
year to breakeven on the purchase cost of an excimer laser. The
commenter stated that the breakeven volume is approximately 3.5 times
higher than the actual volume, with typical utilization of 344
treatments per excimer laser per year. The commenter stated that the PE
cost for one excimer treatment should be no less than $90.45 to achieve
breakeven on the purchase of an excimer laser.
The commenter also stated that, when the AMA RUC reviewed the cost
of the excimer laser, it made changes to the cost elements that are not
reflective of the actual sales cost of the excimer laser, or its cost
of maintenance. The commenter suggested that the sales price has gone
up, along with the increased costs associated with service, inflation,
training. The excimer laser vendor also confirmed in their comment
letter that although they sell the excimer laser to private dermatology
practices and hospital facilities, it is not common. The commenter
stated that about 900 devices of the 1,200 excimer lasers operating in
the Unites States are based on the subscription model.
Another commenter supported our proposal to maintain the equipment
time for EQ161 and remove the three pay-per-use excimer laser
subscriptions from the list of supplies and stated that the equipment
associated with these services can be purchased rather than leased, and
a ``change in business model'' for some practices does not warrant a
drastic shift in how the Agency reimburses for equipment costs borne by
practices. Additionally, the commenter expressed concern that such a
policy could alter market dynamics, pushing more vendors to compel
physician practices into subscription models. The commenter stated that
these models often lead to higher long-term costs, and diminished
flexibility, as ongoing fees and usage restrictions can directly impact
patient care. The commenter also stated that the dependency on vendors'
subscription agreements can erode practices' control over essential
equipment, resulting in unfavorable terms and potential price hikes
over time. The commenter stated that subscription models may worsen
disparities in access to advanced medical technologies, impede the
adoption of innovative treatments, raise significant concerns about
data security and privacy, and increase the risk of market
monopolization, where a few vendors could dominate, driving up costs
and limiting choices for practices. Lastly, the commenter stated that
if CMS were to use vendor subscription charges as the basis for
practice expense payments, there would be no market discipline and
encourage vendors to increase subscription costs, knowing that the
increased cost would be borne by CMS.
Response: We appreciate the commenter's support and input relating
to our request for additional information regarding the difference in
direct PE costs between the purchase and per-use rental of the laser
and 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. 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. We also understand that as the PE data age, these issues
involving subscriptions and other forms of digital tools become more
complex. We look forward to continuing to seek out new data sources to
help in updating the PE methodology.
We also acknowledge the excimer laser vendor's concern that the
purchase price for the excimer laser has increased and the receipt of
invoices related to the parts and labor for the maintenance of a
purchased laser. However, we did not receive invoices that would be
useful to update the purchase price, and that the maintenance of
equipment is accounted for in our price per minute equation for
equipment. We welcome additional information and invoices to
substantiate the claim that the purchase price has increased. 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.
We remind the commenter that we implemented a new methodology for
calculating PE RVUs for CY 2007 where we utilize a ``bottom-up''
approach to calculate the direct costs instead of using the ``top-
down'' approach to calculate the direct PE RVUs, under which the
aggregate direct and indirect costs for each specialty are allocated to
each individual service. Under the ``bottom up'' approach, we determine
the direct PE by adding the costs of the resources (that is, the
clinical staff, equipment, and supplies) typically required to provide
each service. The resource costs are calculated using the refined
direct PE inputs assigned to each CPT code in our PE database, which
are based on our review of recommendations received from the AMA RUC.
Therefore, we disagree with the commenter's suggestion to implement the
``breakeven cost'' of the excimer laser in the equipment formula.
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, as confirmed by
the excimer laser vendor, and is already accounted for with our
equipment methodology is appropriate, especially given its implications
for direct PE costs for these CPT codes. We continue to believe that
the excimer laser is appropriately and adequately accounted for in the
equipment formula, which accounts for years of useful life, utilization
rate, purchase price, interest rate, maintenance, and minutes per year
[[Page 97801]]
of use, discussed in detail in section II.B. of this final rule,
Determination of PE RVUs, and note that EQ161 has a very high cost per
minute of $0.5895/minute.
Comment: Most commenters disagreed with the CPT Editorial Panel's
decisions regarding the codes' indications, which are currently limited
to psoriasis only, stating that the changes have already had far
reaching consequences. Commenters stated that the CPT Editorial Panel's
decisions have negatively impacted a sizable portion of the patient
population with inflammatory skin diseases, particularly for people
with skin of color who are more susceptible to vitiligo. One commenter
requested that CMS create a G code that is based on the 2022 CPT codes
for the excimer laser to substitute for the 2024 revisions.
Response: We appreciate and acknowledge commenters' concerns
regarding the CPT coding. However, based on our understanding, the
coding change application was withdrawn from the September 2023 CPT
Editorial Panel meeting when it was determined that existing literature
was insufficient and did not support expanded indications at that time,
and the codes were resurveyed at the April 2023 RUC meeting without any
revisions to the code descriptors. Therefore, we disagree with the
commenter that there is a programmatic need for a G code. We also note
that concerns related to the CPT changes are considered out of scope
for our proposal and we encourage the commenter to coordinate with the
CPT Editorial Panel to address their concerns regarding the expanded
indications for other inflammatory skin disorders such as vitiligo,
atopic dermatitis, and alopecia areata. After consideration of public
comments, we are finalizing the work RVUs and direct PE inputs for CPT
codes 96920, 96921, 96922 as proposed with the exception of the
finalized refinements of clinical staff time for the CA024 to 5 minutes
and equipment times of 38, 40, and 46 minutes for the power table
(EF031) and exam light (EQ168) equipment for CPT codes 96920, 96921,
and 96922, respectively, to conform to the increased clinical staff
time for CA024.
(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 and 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.
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 16 lists the direct PE costs of each HCPCS code
under their current pricing, under the HCPAC recommendations, and the
alternate APTA and AOTA recommendations:
[[Page 97802]]
[GRAPHIC] [TIFF OMITTED] TR09DE24.020
After consideration of these recommendations, we proposed 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 agreed that some
additional equipment time beyond the timed 15 minutes will be typical
for setup and cleaning, 9 additional minutes for each billing of CPT
code 97110 did 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.
Comment: A commenter stated that although there remains some
uncertainty about the appropriate equipment minutes for this code set,
the commenter applauded CMS and stated that they looked forward to
final resolution on the subject of appropriate equipment minutes.
Response: We appreciate the support from the commenter.
Comment: Several commenters disagreed with the CMS proposal of the
HCPAC's recommended direct PE inputs. Commenters questioned why it was
appropriate to apply the MPPR first through the valuation of the direct
PE inputs and then again during claims processing. Commenters stated
that they remained confused as to whether considering the MPPR, and how
it will reduce clinical labor times for the whole session across the
provided codes, was appropriate for valuing each individual code.
Commenters disagreed with the proposal of 1.33 minutes of clinical
labor time for most of the tasks included in the reviewed therapy
codes, stating that for the second and third services, there is only 40
seconds allotted to tasks such as positioning the patient, cleaning the
separate equipment, or developing post-treatment recommendations. One
commenter stated that spending one and a third minutes is inadequate
for most, if not all, procedures and spending only 40 seconds is not a
realistic allocation of time to ensure that a patient is appropriately
and safely positioned. Commenters suggested that the clinical labor
time for many of the labor tasks assigned 1.33 minutes should in fact
be the full 3 minutes that other non-therapy procedures are allotted
for similar clinical labor tasks. Commenters agreed that a more
thorough discussion of these codes will be required at a future date,
however the commenters did not wish to take these 19 codes back to the
HCPAC until such time as it was clearer how clinical labor and
equipment time should be calculated.
Response: Determining the proper valuation of the clinical labor,
supply, and equipment inputs for these therapy services has been a
difficult task due to multiple billings being typical for the same
patient on the same day. We have a longstanding policy such that in
cases where multiple services are typically furnished to a beneficiary
on the same day, we believe that there is overlap between the two
services in some of the activities furnished during the preservice
evaluation and postservice time. For example, in cases where a service
is typically furnished to a beneficiary on the same day as an E/M
[[Page 97803]]
service, we believe that there is overlap between the two services in
some of the activities furnished during the preservice evaluation and
postservice time. As such, we disagree with the commenters that it
would be appropriate to allocate the full standard 3 minutes of
clinical labor time for tasks such as greeting and gowning the patient
(CA009), which would only take place one time. For therapy services
which are typically billed in 3.5 sessions, this would result in 10.5
minutes of clinical labor time for the CA009 activity, which would be
too high and not maintain relativity with other PFS services. At the
same time, if we were to discount the clinical labor times too heavily
by overapplying the MPPR, we run the risk of under-allocating
sufficient clinical labor to cover the typical case, which could result
in the safety issues identified by the commenters.
With this context in mind, we continue to believe that the direct
PE inputs as recommended by the HCPAC are the most accurate values
based on the current information that we have available. As we noted in
the proposed rule, this is a topic that may warrant additional review
to ensure that this family of codes is properly valued, both in terms
of the equipment minutes discussed in the proposed rule and the
clinical labor times raised by commenters. We agree with the
observation from the commenters that discussing nineteen codes at the
same time appears to have been significantly burdensome on the HCPAC,
and we believe a more robust discussion might take place by reviewing
fewer codes at a time. We remain open to further discussion of this
subject with interested parties of how to most accurately capture the
typical and medically necessary direct PE inputs for these therapy
services in light of the challenges that they pose for valuation.
We wish to clarify for the commenters that we do not believe
patient positioning and similar activities would typically take place
in 40 seconds. We consistently proposed 1.33 minutes of clinical labor
time for the ``Prepare, set-up and start IV, initial positioning and
monitoring of patient'' (CA016) clinical labor task for these therapy
codes based on the HCPAC's recommendation. As detailed in the proposed
rule, this was based on dividing the standard clinical labor times by
2.25 to account for the MPPR, such as taking the standard 3 minutes and
dividing it by 2.25 to arrive at the proposed time of 1.33 minutes
(1.33 + 0.67 + 0.67 + 0.34 = 3 minutes). In other words, we believe
that the standard 3 minutes of positioning time would typically take
place over the course of a therapy session lasting roughly 45-60
minutes, as billed across the typical 3.5 services. We did not propose
that patient positioning or room cleaning would typically take place in
40 seconds as several of the commenters suggested.
Comment: A few commenters asked CMS to use its authority to
temporarily suspend, reduce, or defer the budget neutrality requirement
for RVU adjustments to prevent further payment cuts to therapy
services. One commenter stated that CMS should use its enforcement
discretion and suspend the 50 percent PE reduction due to MPPR from the
19 therapy codes until the therapy codes have been properly valued.
Response: We remind the commenters that CMS does not have authority
under section 1848 of the Act to suspend the budget neutrality
requirement under section 1848(c)(2)(B)(ii)(II) of the Act.
After consideration of the comments, we are finalizing the direct
PE inputs for the 19 CPT codes in the Physical Medicine and
Rehabilitation family as proposed.
(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 proposed the RUC-recommended work RVUs for all four
CPT codes. We proposed 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 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 also proposed the RUC-recommended direct PE
inputs for CPT codes 97810, 97811, 97813 and 97814 without refinement.
Comment: Commenters agreed with the CMS proposed work RVUs and
direct PE inputs for CPT codes 97810 and 97813.
Response: We thank commenters for their support.
Comment: Commenters disagreed with the proposed work RVUs for CPT
codes 97811 and 97814, stating that reduction of the work RVUs could
potentially discourage the delivery of acupuncture and limit the
availability of this beneficial service to the elderly population.
These commenters encouraged CMS to maintain the current work RVUs of
0.50 for CPT code 97811 and 0.55 for CPT code 97814.
Response: We appreciate the feedback but note that the RUC's
Summary of Recommendations (SOR) for CPT codes 97811 and 97814,
contained two key reference codes that appropriately support the
proposed valuation for each code. Without additional data provided by
the commenters, we continue to believe that the RUC-reviewed survey
25th percentile work RVU of 0.46 for CPT code 97811 and 0.47 for CPT
97814 accurately reflects the intra-service and total times for these
codes.
After consideration of the public comments, we are finalizing the
work RVUs and direct PE inputs for all four codes in the Acupuncture--
Electroacupuncture family as proposed.
(28) Insertion, and Removal and Insertion of New 365-Day Implantable
Interstitial Glucose Sensor System (HCPCS Codes G0564 and G0565)
In the CY 2023 PFS final rule (87 FR 6923), we revised national
pricing for two Category III CPT codes that describe continuous glucose
monitoring for a 180-day period. Category III CPT codes 0446T (Creation
of subcutaneous pocket with insertion of implantable interstitial
glucose sensor, including system activation and patient training) and
0448T (removal of implantable interstitial glucose sensor with creation
of subcutaneous pocket at different anatomic site and insertion of new
implantable sensor, including system activation) describe the services
related to the insertion, and removal and insertion of an implantable
180-day interstitial glucose sensor from a subcutaneous pocket. The
implantable interstitial glucose sensors are part of systems that can
allow real-time glucose monitoring, provide glucose trend information,
and signal alerts for detection and prediction of episodes of
[[Page 97804]]
low blood glucose (hypoglycemia) and high blood glucose
(hyperglycemia).
Interested parties submitted a public comment in response to the CY
2025 PFS proposed rule that asked CMS to establish coding and payment
similar to CPT codes 0446T and 0448T for services related to a newly
FDA approved implantable 365-day continuous glucose monitoring system.
The commenter stated that creating new coding will allow for continuity
of this service during the manufacturer's transition from the 180-day
monitoring service as described by the current codes, to the new 365-
day monitoring service.
We agree with the commenters request and are establishing two new
HCPCS codes to describe services related to the new 365-day monitoring
service. Specifically, we are establishing HCPCS code G0564 (Creation
of subcutaneous pocket with insertion of 365-day implantable
interstitial glucose sensor, including system activation and patient
training) and G0565 (removal of implantable interstitial glucose sensor
with creation of subcutaneous pocket at different anatomic site and
insertion of new 365-day implantable sensor, including system
activation). We believe it is important for beneficiaries to have
continued access to this valuable service during the transition from a
180 to 365-day monitoring period. HCPCS codes G0564 and G0565 are
contractor priced and effective January 1, 2025. CPT codes 0446T and
0448T should continue to be used to bill for the 180-day continuous
glucose monitoring service.
(29) 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 proposed the RUC-recommended work RVU of 0.18 for HCPCS code
G0442 (Annual alcohol misuse screening, 5 to 15 minutes). We also
proposed 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 proposed 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 also proposed to
maintain 15 minutes of corresponding equipment time for the EF023 exam
table as a result of our proposed clinical labor time refinement. We
proposed 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.
We received comments on this proposal. Below is a summary of the
comments received.
Comment: Commenters generally supported the CMS proposal of the
RUC's work RVU recommendations for HCPCS codes G0442 and G0443.
Commenters noted the importance of improving rates in connection to
strengthening access to care. Several commenters asked CMS to include
other settings where these services can be furnished such as Certified
Community Behavioral Health Clinics (CCBHCs) and Community Mental
Health Centers (CMHCs) as they would anticipate this screening would be
just as effective in a community setting and there may be cases where
the entity may have an eligible practitioner on staff who is seeing an
individual and recognizes that the annual screening and brief
counseling is clinically appropriate for an individual in need. Another
commenter asked CMS to continue to monitor research on alcohol
screening, counseling, and treatment and incorporate research findings
into the valuation and payment of these services.
Commenters also expressed overwhelming support regarding the
proposed PE refinements, noting that it would not 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 5 minutes recommended by the RUC. One commenter disagreed
with the proposed PE refinements stating that this work was duplicative
with the E/M visit that is being billed on the same day.
Response: We appreciate the support from commenters regarding the
proposed work RVUs for HCPCS codes G0442 and G0443. We appreciate the
commenters' suggestion of including CCBHCs and CMHCs as settings where
these services can be performed. We note that practitioners who
practice in these settings and who are enrolled in Medicare and able to
bill directly for their services may be able to bill for HCPCS codes
G0442 and G0443 under the PFS.
After consideration of public comments, we are finalizing the work
RVUs for HCPCS codes G0442 and G0443 as proposed.
[[Page 97805]]
For the direct PE inputs, we agree with commenters that it would
not 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 5 minutes recommended by the RUC.
Given the overwhelming support from commenters and the fact that these
are preventative services, we are finalizing as proposed 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. We are also finalizing to maintain 15
minutes of corresponding equipment time for the EF023 exam table
because of our proposed clinical labor time refinement. We are
finalizing the RUC-recommended direct PE inputs for HCPCS code G0443
without refinement.
(30) 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 proposed the RUC-recommended work RVU of 0.18 for HCPCS code
G0444.
We proposed 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 also proposed to
maintain 15 minutes of corresponding equipment time for the EF023 exam
table as a result of our clinical labor time refinement.
We received comments on our proposals. Below is a summary of the
comments received.
Comment: Commenters generally supported the CMS proposal of the
RUC's recommended work RVU for G0444. Several commenters asked CMS to
include other settings where these services can be furnished such as
Certified Community Behavioral Health Clinics (CCBHCs), Community
Mental Health Centers (CMHCs), as well as substance use treatment
settings, as they would anticipate this screening would be just as
effective in a community setting and there may exist cases where the
entity may have an eligible provider on staff who is seeing an
individual and recognizes that the annual screening and brief
counseling is clinically appropriate for an individual in need. A few
commenters encouraged CMS to use the most recent data available to
determine the appropriate payment for Mental Health (MH) and Substance
Use Disorder (SUD) services to address workforce shortages. Commenters
overwhelmingly agreed with CMS regarding the clinical labor time and
stated that the current 15 minutes of clinical labor time would be more
typical to ensure the accuracy of this screening procedure. One
commenter disagreed with CMS' proposed refinements to the PE inputs
stating this work was duplicative with the E/M that is being billed on
the same day.
Response: We thank the commenters for their support of this
proposal. We appreciate the commenters' suggestion of including CCBHCs
and CMHCs as settings where these services can be performed. We note
that practitioners who practice in these settings and who are enrolled
in Medicare and able to bill directly for their services may be able to
bill for these codes under the PFS.
After consideration of public comments, we are finalizing the work
RVU for HCPCS code G0444 as proposed.
For the direct PE inputs, we thank the commenters for their support
and agree with commenters that it would not 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 5
minutes recommended by the RUC. Given the overwhelming support from
commenters and the fact that this is a preventative service, we are
finalizing as proposed 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. We are
also finalizing as proposed to maintain the 15 minutes of corresponding
equipment time for the EF023 exam table because of our proposed
clinical labor time refinement.
(31) 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 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 proposed the RUC-recommended work RVU of 0.45
for each of these three HCPCS codes, G0445-G0447.
We did not propose the RUC-recommended direct PE inputs for these
codes because of the insufficient number of survey responses, and
further, we did not agree with some of the RUC's refinements to the
direct PE inputs for this service. We did not propose 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
[[Page 97806]]
as reflected by the survey median. We do not agree that these changes
are substantiated given the insufficient number of survey responses and
we proposed to maintain the current values for each of these direct PE
inputs.
We proposed the RUC recommended refinements to clinical staff time
for HCPCS code G0445. We proposed 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
also proposed the RUC recommendations to eliminate both of these pieces
of equipment from the PE for HCPCS code G0445.
We noted 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.
We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: Commenters generally expressed support regarding the
proposed PE refinements although one commenter disagreed with the
proposed PE refinements, stating that this work was duplicative with
the E/M visit that is being billed on the same day. Commenters
recommended an increase in the work RVUs for HCPCS codes G0445-G0447 in
alignment with HCPCS code G0443 (Brief face-to-face behavioral
counseling for alcohol misuse, 15 minutes) to reflect the intensity of
the services, stimulate additional access to these services, and
maintain relativity across these codes. Commenters also noted the
importance of improving the accuracy of the rates in order to
strengthening access to care.
Response: We thank commenters for their support of our PE
refinements. We disagree that the PE of the counseling service is
duplicative of the E/M visit that is being billed on the same day, as
the counseling service requires additional time and practice expense
not originally accounted for in the valuation of the E/M visit that is
billed on the same day. We appreciate the information that commenters
provided regarding the proposed work RVU for HCPCS codes G0445-G0447.
We were persuaded by commenters that these services should all be
valued consistently to reflect the intensity of the service and to
maintain relativity across these codes. We are finalizing 0.60 work
RVUs for HCPCS code G0443 (Brief face-to-face behavioral counseling for
alcohol misuse, 15 minutes).
After consideration of public comments, we are finalizing the work
RVU of 0.60 for HCPCS codes G0445-G0447 and finalizing our PE and
clinical staff time refinements as proposed.
(32) 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 code 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 proposed to establish national pricing
for HCPCS code G0465 for CY 2025. We proposed 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.\20\ \21\ \22\ \23\ We proposed 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 also proposed
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 noted that the
[[Page 97807]]
payment includes debridement, which may involve a wound reaching the
bone. Therefore, debridement may not be billed separately. In addition,
we currently sought 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
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 solicited comments regarding our selection of CPT
code 15271 as a crosswalk code, as well as general comments and
available studies regarding the appropriate valuation of HCPCS code
G0465.
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\20\ 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.
\21\ 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.
\22\ 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.
\23\ 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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Comment: While many commenters supported establishing national
pricing for HCPCS code G0465 for CY 2025, they disagreed with the
proposed crosswalk to CPT codes 15271, 15273, and 15277. Commenters
asserted that these codes do not accurately reflect the work RVUs and
non-facility PE RVUs required for providing this treatment in a
physician office setting. Commenters stated that autologous blood-
derived products are not skin substitutes, and therefore, the proposed
skin substitute crosswalk codes do not adequately account for all the
steps involved in preparing and delivering this wound care treatment.
They highlighted that platelet-rich plasma (PRP) requires significant
point-of-care preparation, unlike skin substitutes. According to the
commenters, the physician work for G0465 includes multiple steps, such
as drawing blood, preparing the blood-derived gel, and applying it to
complex wounds--procedures that are more involved than applying a skin
substitute. The commenters emphasized that the proposed work RVUs based
on the crosswalks are too low and do not account for the substantial
physician effort required. Several commenters instead suggested
alternative crosswalks to CPT codes related to epidermal or dermal
autografts, such as CPT codes 15110 (Epidermal autograft, trunk, arms,
legs; first 100 sq cm or less, or 1% of body area of infants and
children), 15115 (Epidermal autograft, face, scalp, eyelids, mouth,
neck, ears, orbits, genitalia, hands, feet, and/or multiple digits;
first 100 sq cm or less, or 1% of body area of infants and children),
15120 (Split-thickness autograft, face, scalp, eyelids, mouth, neck,
ears, orbits, genitalia, hands, feet, and/or multiple digits; first 100
sq cm or less, or 1% of body area of infants and children (except
15050)), which they believe better align with the actual work involved.
Several commenters also stated that debridement is a crucial part
of the physician's work when performing the service described by HCPCS
code G0465, particularly for complex wounds that may involve tunneling
or contact with bone. They emphasized that debridement, which is
essential before each application of an autologous blood-derived
product, should be factored into the RVU calculation for HCPCS code
G0465. Commenters recommended considering relevant debridement codes,
such as CPT codes 11042 (Debridement, subcutaneous tissue (includes
epidermis and dermis, if performed); first 20 sq cm or less), 11043
(Debridement, muscle and/or fascia (includes epidermis, dermis, and
subcutaneous tissue, if performed); first 20 sq cm or less), 11044
(Debridement, bone (includes epidermis, dermis, subcutaneous tissue,
muscle and/or fascia, if performed); first 20 sq cm or less), and 97597
(Debridement (e.g., high pressure waterjet with/without suction, sharp
selective debridement with scissors, scalpel and forceps), open wound,
(e.g., fibrin, devitalized epidermis and/or dermis, exudate, debris,
biofilm), including topical application(s), wound assessment, use of a
whirlpool, when performed and instruction(s) for ongoing care, per
session, total wound(s) surface area; first 20 sq cm or less). Assuming
debridement is not separately payable, a few commenters suggested
increasing the work RVUs for HCPCS code G0465 by incorporating values
from these debridement codes.
In addition, some commenters stated that the proposed pricing for
supply code SD343, the 3C patch system, is outdated and inaccurate.
They stated that the SD343 supply does not reflect the typical supply
costs for PRP services because certain necessary components for PRP
preparation and application are not included in the 3C patch system.
Commenters also asserted that only products with FDA-cleared
indications for wound care should be included in the national pricing
for HCPCS code G0465, and products that do not meet these requirements
should be excluded. Commenters stated that there may be other products
in the market that do not meet the NCD requirements and cautioned that
these other products likely have vastly different costs than products
that do meet the NCD requirements. Commenters stated that the FDA-
cleared manufacturers sell their proprietary ingredients and supplies
as a complete package, which are necessary for use in each
manufacturer's process for creating the autologous blood-derived
products, and they are not interchangeable between manufacturers.
Commenters submitted a series of invoices and requested that CMS use
them to update the pricing of the SD343 supply.
Response: We thank commenters for their feedback. We were persuaded
by commenters that the higher work valuation would provide a more
accurate crosswalk for HCPCS code G0465, as PRP may require more work
and complexity in using these products. To ensure adequate valuation of
both physician work and practice expense, we are modifying our original
proposal and instead finalizing national pricing for HCPCS code G0465
for CY 2025 using a crosswalk to CPT code 15275 (Application of skin
substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits,
genitalia, hands, feet, and/or multiple digits, total wound surface
area up to 100 sq cm; first 25 sq cm or less wound surface area)
instead of CPT code 15271 because we believe this code more accurately
reflects the work involved in furnishing the service described by HCPCS
code G0465.
After reviewing the invoices submitted by commenters, we agree that
the pricing data indicates an increase in the typical price of the
SD343 supply over time. Therefore, we are finalizing an increase in the
supply price from $678.57 to $770.83, based on twelve submitted
invoices. Where prices appear inaccurate, and direct inputs do not
reflect the full range of available PRP products, we encourage
interested parties to submit invoices or other relevant information by
February 10th of the following year to improve pricing accuracy in the
direct PE database, following a process similar to our consideration of
RUC recommendations.
Lastly, while we acknowledge that the service provided under HCPCS
code G0465 may differ from skin substitutes, we consider the work to be
comparable, which is why we are using CPT code 15275 as the crosswalk.
Because the code descriptor for HCPCS code G0465 includes description
of all other preparatory procedures, we do not agree that the
additional work described in the debridement codes referenced by
commenters is not accounted for in the valuation of HCPCS code G0465.
Therefore, we are finalizing a work RVU of 1.83 for HCPCS code G0465,
which
[[Page 97808]]
is higher than the work RVU for CPT code 15271 as proposed, based on a
crosswalk to CPT code 15275. Additionally, we are finalizing an
increase in the supply price to $770.83, based on twelve submitted
invoices.
(33) 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 recommended 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 encouraged 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 did not propose
national pricing for these two Category III codes, we did note for the
benefit of the MACs that CPT code 0596T will typically include one of
each of these supplies, whereas CPT code 0597T will typically include
only one of the supplies (SD371).
We encouraged the MACs to continue to engage with interested
parties by providing information on how they price these services. We
welcomed 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.
Comment: Commenters supported the establishment of new supply codes
(SD370, SD371, and SD372) for the inFlowTM female voiding
prosthesis system (the inFlow System), which addresses the needs of
women with permanent urinary retention (PUR). According to the
commenters, the inFlow System offers a critical alternative to
traditional intermittent catheterization, providing significant
improvements in both health outcomes and quality of life for women with
neurological conditions that limit their ability to self-catheterize.
They stated that creating three new supply codes would standardize and
improve payment rates by Medicare Administrative Contractors (MACs),
thereby reducing access barriers and increasing the utilization of the
inFlow system. They emphasized that finalizing appropriate pricing for
these device-intensive procedures, as proposed, is essential to
ensuring that Medicare beneficiaries have access to this important,
life-enhancing technology.
Response: We thank commenters for their overwhelming support for
our proposal. After consideration of public comments, we are finalizing
creation of three new supply codes in the PE database to facilitate
appropriate pricing by the MACs: 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) as
proposed.
[[Page 97809]]
(34) 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 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 proposed assigning contractor pricing to this
PE-only code for CY 2025. We proposed a new code, HCPCS code G0555
(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 sought
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
solicited comments on additional direct PE inputs that we should
consider.
Comment: Many commenters disagreed with our proposed new code,
HCPCS code G0555 (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). Many commenters stated that the proposed HCPCS code
G0555 does not align with the current distribution and billing
framework because it conflates two distinct functions: replacement of
the patient electronics system (PES), often furnished by durable
medical equipment (DME) suppliers, and reporting test results to the
physician, usually performed by outpatient hospital departments (OPDs)
and independent diagnostic testing facilities (IDTFs). Due to these
separate functions handled by different parties, some commenters
recommended splitting HCPCS code G0555 into two distinct codes--one for
PES replacement and another for reporting test results. They agreed
that contractor pricing the proposed new code would be appropriate for
the replacement PES.
Additionally, commenters raised concerns regarding the removal of
the previous monitoring code (G2066) for CardioMEMS monitoring. Some
commenters stated that CMS's decision to delete HCPCS code G2066, which
was used for reporting the technical component of remote monitoring,
has created a billing gap for IDTFs and OPDs. Commenters recommended
creating a new code to allow these facilities to report the technical
aspects of monitoring; they specifically asked for the establishment of
coding that enables IDTFs and OPDs to bill for these services, with
contractor pricing as an interim solution.
Response: First, we note that the replacement of the PES does not
meet the criteria of DME as outlined in section 1861(n) of the Act. For
more information, please refer to the DMEPOS Public Meeting on 6/1/
2016, Application #16.019--Request to establish a new Level II HCPCS
code to identify the replacement Patient Electronic System at https://www.cms.gov/Medicare/Coding/MedHCPCSGenInfo/Downloads/2016-06-01-HCPCS-Application-Summary.pdf. Secondly, we clarify that the last part of the
proposed code descriptor (reporting of test results to physician or
qualified health care professional) refers to the capability of the
equipment, not the act of reporting. In other words, the code is not
describing two distinct services; therefore, separate coding is
unnecessary. We also believe that establishing additional coding for
reporting the technical component of remote monitoring is unnecessary.
Following CMS's decision to delete HCPCS code G2066, the services
previously reported using HCPCS code G2066 will now be reported using
the technical component of CPT codes 93297 and 93298. Our rationale for
finalizing these values was discussed extensively in the CY 2024 PFS
final rule (88 FR 78913 through 78914).
After considering the public comments, we are finalizing the
proposed descriptor with modifications. The final descriptor for HCPCS
code G0555 is Provision of replacement patient electronics system
(e.g., system pillow, handheld reader) for home pulmonary artery
pressure monitoring. We believe these revisions will allow flexibility
in coding and provide greater access for patients. We are finalizing
contractor pricing as proposed.
(35) 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
[[Page 97810]]
of these services, including the application of an inflation factor.
We acknowledged the interested parties' concerns and clarified 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 proposed 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.
We received public comments on our proposal. The following is a
summary of the comments we received and our responses.
Comment: Many commenters supported CMS' proposal to revise language
in the Medicare Claims Processing Manual (MPCM) and believe this will
help assure that MACs apply appropriate inflation factor and other
required updates to PXR services.
Response: We thank commenters for their support of our proposal.
Comment: Commenters also mentioned a few additional policy
refinements for PXR services including requiring transparency from MACs
regarding the annual update as well as with the PFS ratesetting process
for direct and indirect costs, establishing guidelines for a timelier
periodic review process, and specifically consolidating two sections of
the MCPM related to PXR transportation (Ch. 13, 90.3 and Ch. 23, 30.5)
to ensure a single guidance document for both MACs and PXR suppliers.
Response: We thank commenters for these suggestions and may take
them into consideration for future rulemaking.
After consideration of the comments received, we are finalizing our
proposal to revise language in our Medicare Claims Processing manual
(Chapter 13, 90.3 and Chapter 23, 30.5) to reflect updates to our
guidance for these services. The Medicare Claims Processing manual is
available at https://www.cms.gov/regulations-and-guidance/guidance/manuals/internet-only-manuals-ioms-items/cms018912.
(36) 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 proposed 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 noted 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 proposed 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 solicited and welcomed comments on our proposal to
revise the IOM to better reflect how complex non-chemotherapeutic drug
administration infusion services are furnished and billed.
Comment: Commenters were generally very supportive of CMS' proposal
to update the IOM with additional detail and considerations of
complexity for the administration of complex non-chemotherapeutic
drugs. Commenters also stated they were pleased that MACs have retired
the LCAs related to this service and that CMS has issued previous
instructions to the MACs regarding down coding. A few commenters
suggested additional clarifications and revisions beyond the proposed
language in the IOM, such as a clarification that stem cell transplant
and CAR-T services should not be billed using the chemotherapy
administration code series. Another commenter requested that CMS remove
``chemotherapy'' terminology and replace it with ``immunomodulatory''
and that CMS extend additional IOM guidance to subcutaneous injections.
One commenter also requested that CMS refer the entire code series to
the CPT Editorial Panel for review.
Response: We appreciate commenters support for our proposed
revisions to the IOM for these services and we acknowledge commenters
additional suggestions to clarify the guidance. Currently, we believe
that additions beyond our proposed changes to the IOM and revisions to
terms beyond the scope of general coding guidance are not
[[Page 97811]]
required. We continue to believe that the proposed increased detail in
alignment with current CPT coding definitions will provide clear
guidance and considerations when MACs are determining appropriate
payment for these services. Additionally, CMS is an active participant
in the CPT Editorial Panel review process and encourages interested
parties to pursue coding change requests by CPT as necessary.
Comment: Several commenters requested that CMS take additional
steps to prevent future down coding of these services. Commenters
stated that CMS should establish documentation requirements in the
patient medical record to demonstrate that the reported complex drug
administration code meets IOM guidance. Commenters also requested that
CMS release a Medicare Learning Network (MLN) article to educate MACs
and physicians on the finalized guidance. Commenters also urged CMS to
prohibit audits and recoupments for these services until the effective
date of the finalized IOM revisions.
Response: We thank commenters for their suggested additional steps
to prevent future down coding of these services. Currently, we believe
that the proposed increased detail and considerations of complexity to
the IOM will sufficiently assist MACs with their determination of
proper payment for these services. We are encouraged by the positive
feedback from commenters regarding the retired LCAs and the previous
instructions issued to the MACs via TDL and CR. We will continue to
monitor all feedback from external parties and will pursue additional
steps to ensure proper payment for these services as necessary.
After consideration of all public comments, we are finalizing
revisions to the IOM to update guidance on complex non-chemotherapeutic
drug administration as proposed.
(37) Hospital Inpatient or Observation (I/O) Evaluation and Management
(E/M) Add-On for Infectious Diseases (HCPCS Code G0545)
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 proposed 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 descriptor for the hospital I/O E/M visit complexity add-on code
is HCPCS code G0545 (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 G0545 would be reported by physicians with specialized infectious
disease training.
We stated in the proposed rule that we do not believe we should
limit the scope of codes with which this add-on HCPCS code could be
billed based on visit level; or initial, same day discharge, or
subsequent hospital inpatient or observation codes. We proposed HCPCS
code G0545 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
[[Page 97812]]
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 G0545 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 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 G0545, we proposed 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 work RVU of 0.89.) We
stated in the proposed rule that 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 proposed new HCPCS
code G0545, compared to what we believe would 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 proposed a total time of 30 minutes for
HCPCS code G0545 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 proposed the same for HCPCS code G0545.
We stated that we believe that the 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
[[Page 97813]]
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 sought comment on the typical amount
of time infectious disease physicians spend on the service elements and
the relative intensity compared to similar service elements of other
CPT codes. We noted that the valuation of HCPCS code G0545 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 noted that we addressed 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) 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 sought 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 noted
that understanding the barriers to utilizing these codes is important,
as these codes would serve as the base codes for the proposed HCPCS
code G0545 and would be billed by the infectious disease physician
prior to billing HCPCS code G0545.
Finally, we recognized 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 noted that we would consider using any newly
available CPT coding to describe services similar to those described
here in future rulemaking.
We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: Many commenters supported our proposal to create a new
HCPCS code to describe intensity and complexity inherent to hospital
inpatient or observation care associated with a confirmed or suspected
infectious disease. Specifically, commenters supported the code's
creation, the proposed work RVU, code descriptor, code structure to be
an add-on code to certain I/O E/M codes, and the three proposed service
elements of the codes.
Some commenters requested clarification on certain aspects of the
code. Specifically, some commenters requested clarification that
performing one, or any combination, of the three proposed service
elements would be sufficient to bill for the code because it would not
be feasible to require all three in a single instance. One commenter
asked for clarification regarding the intention to recognize the
inherent complexity for all infectious diseases (for example, bacterial
infections, MRSA, C. diff, COVID-19) or primarily emerging viral/
microbial infections with epidemic potential. The commenter also
requested clarification on the exclusion of the I/O E/M discharge CPT
codes 99238 (Hospital inpatient or observation discharge day
management; 30 minutes or less on the date of the encounter) and 99239
(Hospital inpatient or observation discharge day management; more than
30 minutes on the date of the encounter), on the specified list of
applicable base codes for HCPCS code G0545, and the inclusion of CPT
code 99213 (low MDM) in the work RVU analysis. The commenter stated
that diagnosing and managing suspected, known, or emerging infectious
diseases typically involves high medical decision making, therefore,
CPT code 99215 (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.) would be more
appropriate for potential work RVU comparisons. Lastly, the commenter
requested clarification on the proposed total time of 30 minutes. The
commenter asked if the proposed total time of 30 minutes is used to
determine the quantity of reportable units of HCPCS code G0545, or if
only one unit of HCPCS code G0545 is reportable per encounter.
Some commenters requested clarification that that no additional
documentation requirements were being established, similar to HCPCS
code G2211, and suggested that the infectious disease specialist's
medical record should sufficiently demonstrate inherent complexity.
Response: We appreciate the overwhelming support from commenters
regarding all elements of the proposed HCPCS code G0545. Regarding the
clarifications requested about the three proposed service elements, we
confirm that HCPCS code G0545 is intended to be used for one, or any
combination, of the three proposed service elements. We recognize that
each service element may not be medically appropriate for every patient
with an infectious disease. Furthermore, we are clarifying that HCPCS
code G0545 is intended to recognize the inherent complexity for all
infectious diseases, and not just emerging infectious diseases with
epidemic potential. Clostridium Difficile infection, for example, can
complicate antibiotic selection and can spread from patient to patient
in an inpatient setting without proper infection prevention strategies
put in place, requiring several of the code descriptor elements be
performed by the treating clinician. As stated in the proposed rule, we
continue to believe the relationship between 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
HCPCS code G0545, compared to what we believe would be a common base
code for this new add-on code, CPT code 99223. This assumption is
supported by 2022 Medicare utilization data for the infectious disease
specialty, available on the CMS website under downloads for the CY 2025
PFS final rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html. If we take the
commenter's suggestion and use CPT code 99215 in our analysis to
represent the high MDM O/O E/M visit, this would decrease the work RVU
for
[[Page 97814]]
HCPCS G0545 (that is, the work RVU of CPT code 99223 divided by the
work RVU of CPT code 99215, 3.50 divided by 2.80, which equals 1.25.
Multiplying the 0.33 work RVU of HCPCS code G2211 times 1.25 would
result in a work RVU of 0.41.). We acknowledge that this was likely not
the commenter's intention, and that CPT code 99223, used in the
proposed work RVU analysis, represents the most common initial I/O E/M
visit billed by the infectious disease specialty in 2022 Medicare
utilization data, and represents high MDM. Additionally, CPT code 99232
is the most common I/O E/M visit billed by the infectious disease
specialty, which represents the subsequent I/O E/M visit with moderate
MDM, but using this code in the work RVU analysis would also decrease
the work RVU calculation for HCPCS code G0545 (that is, the work RVU of
CPT code 99232 divided by the work RVU of CPT code 99213, 1.59 divided
by 1.30, which equals 1.22. Multiplying the 0.33 work RVU of HCPCS code
G2211 times 1.22 would result in a work RVU of 0.40.). We note that the
work RVU analysis for HCPCS code G0545 was not intended to indicate an
assumption about the level of medical decision making associated with
diagnosing and managing suspected, known, or emerging infectious
diseases, and we continue to believe that the comparison of HCPCS code
G2211 and CPT code 99213, compared to CPT code 99223 strikes the
correct balance to estimate the typical time and complexity associated
with HCPCS code G0545, therefore we are finalizing our proposed work
RVU of 0.89 for HCPCS code G0545. Additionally, we agree with the
commenter that the I/O E/M discharge day management CPT codes are
applicable base codes for HCPCS code G0545, as they were inadvertently
omitted from the list of applicable base codes in the CY 2025 PFS
proposed rule, therefore we are finalizing the inclusion of CPT codes
99238 and 99239 to the list of base codes.
We note that, while we proposed a total time of 30 minutes for
HCPCS code G0545, similar to HCPCS code G2211, HCPCS code G0545 is not
intended to be a time-based code. The proposed total time adheres to a
longstanding practice of establishing times for a new code to represent
the anticipated typical time of a service and should not be used to
determine reportable units of the code. We acknowledge that I/O E/M
visit levels and prolonged service codes are intended to account for
additional minutes of time for individual patients, whereas HCPCS code
G0545 is intended to account for the visit complexity inherent to
hospital inpatient or observation care associated with a confirmed or
suspected infectious disease. For time-based reporting of additional
incremental time, we refer the commenter to the prolonged hospital I/O
E/M code, 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)).
Like HCPCS code G2211, we did not specify any additional medical
record documentation requirements for reporting the HCPCS code G0545
add-on code. Our medical reviewers may use the medical record
documentation to confirm the medical necessity of the visit and the
confirmed or suspected infectious disease as appropriate. We would
expect that information included in the medical record or in the claims
history for a patient/practitioner combination, such as diagnoses, the
practitioner's assessment and medical plan of care, and/or other codes
reported could serve as supporting documentation for billing HCPCS code
G0545. Practitioners should consult their Medicare Administrative
Contractor (MAC) regarding documentation requirements related to the
underlying I/O E/M visit.
Comment: Some commenters requested the code to be modified to a
stand-alone code rather than an add-on code because the work described
by this code may be done with or without the medical necessity of a
face-to-face visit. Commenters stated that there are barriers for
infectious disease specialists in reporting the inpatient daily care
codes that are proposed as base codes for HCPCS code G0545 because the
medical decision-making is based on review of significant amounts of
data in medical records and can be done without a face-to-face visit
with the patient. Therefore, commenters requested that HCPCS code G0545
be a stand-alone code rather than an add-on code to the proposed
hospital I/O E/M codes.
Response: We appreciate the commenters' suggestion of modifying
HCPCS code G0545 to be a stand-alone code given the possible barriers
to reporting the proposed base codes. However, at this time, we are
finalizing HCPCS code G0545 as an add-on code as proposed because we
did not receive any commenter input on appropriate definition or
valuation for the code as a stand-alone code such as a code descriptor,
service elements, physician time, work RVU, and what codes would be
inappropriate to bill alongside a stand-alone infectious disease code
to avoid duplicative payment for these services.
We also note that there are interprofessional consultation codes,
CPT codes 99451 (Interprofessional telephone/internet/electronic health
record assessment and management service provided by a consultative
physician or other qualified health care professional, including a
written report to the patient's treating/requesting physician or other
qualified health care professional, 5 minutes or more of medical
consultative time), 99452 (Interprofessional telephone/internet/
electronic health record referral service(s) provided by a treating/
requesting physician or other qualified health care professional, 30
minutes), and 99446 (Interprofessional telephone/internet/electronic
health record assessment and management service provided by a
consultative physician or other qualified health care professional,
including a verbal and written report to the patient's treating/
requesting physician or other qualified health care professional; 5-10
minutes of medical consultative discussion and review) through 99449
(Interprofessional telephone/internet/electronic health record
assessment and management service provided by a consultative physician
or other qualified health care professional, including a verbal and
written report to the patient's treating/requesting physician or other
qualified health care professional; 31 minutes or more of medical
consultative discussion and review), that could be used to report non-
face-to-face consults furnished by infectious disease specialists.
These 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
[[Page 97815]]
and/or management of the patient's problem without the need for the
patient's face-to-face contact with the consulting physician or
qualified healthcare professional (83 FR 59489).
Comment: One commenter requested clarification about reporting both
HCPCS codes G2211 and G0545 because infectious disease specialists are
likely to report their visits with the office/outpatient (O/O) E/M
codes, since they are rarely the physician ordering and providing the
observation service who will report the hospital I/O E/M codes.
Response: We appreciate the commenter's input regarding the use of
the new HCPCS code G0545. However, HCPCS codes G2211 and G0545 have
differing base codes and therefore, cannot be reported together. We
acknowledge that some commenters raised concerns about barriers to
reporting the proposed base codes for HCPCS code G0545, but no other
commenters raised that they typically use the O/O E/M codes. We also
note that 2022 Medicare utilization data, available on the CMS website
under downloads for the CY 2025 PFS final rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html
does not support the assertion that infectious disease specialists are
likely to report their visits with the office/outpatient (O/O) E/M
codes, therefore, we continue to believe that the proposed base codes
for HCPCS code G0545 are appropriate. We are open to feedback from
interested parties and may consider additional information for future
rulemaking.
Comment: Some commenters requested that we allow a broader scope of
qualifying practitioners to be able to bill for HCPCS code G0545 in
order to ensure nurses and other qualified practitioners can bill for
the expert care they provide in treating infectious diseases.
Response: We appreciate the commenters' suggestion to broaden the
scope of practitioners who may bill for HCPCS code G0545. We agree with
commenters that it is possible that practitioners other than physicians
could provide vital care in treating infectious diseases. Therefore, we
are finalizing a modified code descriptor for HCPCS code G0545 that
refers to ``an infectious diseases specialist'' to enable all
practitioners with specialized training in infectious diseases who can
independently bill Medicare for E/M visits to report the HCPCS code
G0545 add-on code to the following I/O E/M base codes: CPT codes 99221
through 99223, 99231 through 99233, 99234 through 99235, and 99238
through 99239. The finalized full descriptor for the hospital I/O E/M
visit complexity add-on code is HCPCS code G0545 (Visit complexity
inherent to hospital inpatient or observation care associated with a
confirmed or suspected infectious disease by an infectious diseases
specialist, including disease transmission risk assessment and
mitigation, public health investigation, analysis, and testing, and/or
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,
subsequent or discharge). We maintain the expectation that HCPCS code
G0545 will be reported by practitioners who have the requisite
specialized infectious disease training, including but not limited to
physicians, nurse practitioners, physician assistants, and certified
nurse specialists.
Comment: A few commenters did not support the creation of HCPCS
code G0545, stating that they do not support specialty-specific codes
because these codes favor the expertise of one specialty more than
others. The commenters stated that CPT codes are not meant to be
specialty specific, and this proposal goes against long-standing
convention and can cause additional imbalances. Instead, the commenters
requested a generalized G code for complex inpatient non-procedural
care that all specialties could use, like HCPCS code G2211. Commenters
stated that there is no clear reason to solely enhance payment for
infectious disease specialists via an add-on code when there are
various other specialties that frequently provide vital E/M services in
inpatient settings whose professional services are undervalued under
the current fee schedule. Commenters stated that this represents a
broader issue with undervaluation of E/M services, and that they are
willing continue to work with CMS, as well as legislators and other
stakeholders, on strengthening physician payment to meet broader
workforce needs.
Response: We appreciate the commenters' input regarding specialty-
specific codes. We continue to believe that the increased work and
unique complexity associated with diagnosis, management, and treatment
of infectious diseases are not adequately accounted for in the current
hospital I/O E/M codes. We reiterate our belief that 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, healthcare staff, and
other patients in the facility. 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 to achieve
broader public health goals.
After consideration of public comments, we are finalizing the
creation of HCPCS code G0545 as proposed with modifications to the
HCPCS code descriptor. We reiterate that we would consider using any
newly available CPT coding to describe infectious disease services in
future rulemaking.
(38) 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 section 1861(ddd) additional preventive services
authority, and a final NCD was published on September 30, 2024. For CY
2025, we proposed national rates for these HCPCS codes that reflect the
relative resource costs associated with the counseling and drug
administration portions of the service,
[[Page 97816]]
pending finalization of the NCD. For HCPCS code G0011, we proposed 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 proposed 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 proposed 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.
Comment: We received several comments regarding CMS' proposed
national payment rates for HCPCS codes G0011, G0012, and G0013. Some
commenters agreed with CMS' proposed work RVU and direct PE inputs for
this code family while one commenter disagreed with the crosswalk code,
CPT code 99211, for HCPCS code G0013. This commenter suggested that CMS
crosswalk this code to CPT code 99213 to better account for time and
complexity.
Response: We appreciate commenters' support for the proposed
national payment rates for this service. We disagree with commenters
and continue to believe that CPT code 99211 is the appropriate
crosswalk for HCPCS code G0013 because CPT code 99211 describes a
counseling service conducted by clinical staff as opposed to a
physician or QHP. This aligns with the code descriptor for 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) which also describes the work of
clinical staff.
Comment: We received several comments expressing a variety of
concerns related to the coverage policy for this service as described
in the proposed NCD. Many comments included a request for better
inclusion of pharmacists. Some comments would like CMS to partner with
pharmacies to allow pharmacists to order HIV PrEP medications, as well
as provide the counseling portion of the service. Commenters also asked
CMS to clarify that pharmacists are considered clinical staff and/or
streamline billing processes to enable pharmacists to bill for PrEP
services under their own National Provider Identifier (NPI).
Response: We appreciate and acknowledge commenters' concerns
regarding the coverage policy in our proposed NCD. However, concerns
related to the coverage policy of HIV PrEP are considered out of scope
for our proposal regarding the national payment rates for this service.
After consideration of the public comments, we are finalizing the
work RVU and direct PE inputs for HIV PrEP as proposed.
(39) 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 proposed 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 proposed 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 also proposed 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 proposed a price of
$32.50 for the supply input that describes a 65mg capsule of Opfolda
(supply code SH111). We sought feedback from interested parties on our
proposal of national pricing, as well as our work RVU and direct PE
inputs for HCPCS code G0138 to ensure proper payment for this service.
Comment: Regarding the proper payment for this service, one
commenter stated that the correct WAC for supply code SH111 (65mg
Opfolda pill) is $33.00 per pill and that the typical dosage of SH111
is 3 to 4 pills per patient, which would mean the total acquisition
cost would be $132. The commenter also stated that they believe the
infusion time for Cipaglucosidae alfa-atga incorporated in G0138 should
be 4 to 5 hours instead of 1 hour and that the CPT crosswalk code 96365
does not adequately account for that time. Finally, the commenter
requested that CMS incorporate the overhead and clinical staff expenses
incurred after the administration of Opfolda and while the patient is
observed.
Response: We thank the commenter for providing information to
update the national payment for this service. We agree with the
commenter that the prescribing information indicates that the typical
dosage of Opfolda is 260mg for patients weighing >=50 kg. We also agree
with the commenter that the typical infusion time for Cipaglucosidae
alfa-atga is 4 hours. However, we disagree with the commenter and
continue to believe that CPT code 96365 is the appropriate crosswalk
code for the infusion portion of the service. The overall increase in
infusion time can be added to the direct PE equipment input to account
for the extra 3 hours. We also believe that the 1 minute of L056A
clinical staff time during the preservice portion of the service period
adequately captures the RN/OCN observation of the patient during self-
administration of the Opfolda pill. After consideration of the public
comments, we are increasing the quantity of supply code SH111 in HCPCS
code G0138 to 3.5 pills based on an average patient weight at a WAC of
$33.00 per pill. We are also increasing the direct PE equipment time
for EQ032 IV infusion pump and EF009 medical recliner chair from 60
minutes to 240
[[Page 97817]]
minutes. The work RVU and other direct PE inputs will be finalized as
proposed.
(40) 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 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 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 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 also proposed 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.
We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: Commenters requested clarification that caregiver training
services (described by 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) may be provided by auxiliary personnel incident to the
services of a billing practitioner.
Response: Payment for CTS may be made to physicians, nurse
practitioners (NPs), clinical nurse specialists (CNSs), certified
nurse-midwives (CNMs), physician assistants (PAs) and clinical
psychologists (CPs) under the PFS when they bill for CTS personally
performed by them or by other practitioners or auxiliary personnel as
an incident to their professional services.
Comment: Commenters requested that we clarify whether practitioners
who are limited by statute to performing services for the diagnosis and
treatment of mental illness (such as clinical psychologists, clinical
social workers, marriage and family therapists, or mental health
counselors) can furnish caregiver training services.
Response: Clinical social workers, marriage and family therapists,
and mental health counselors can bill Medicare directly for caregiver
training services they personally perform for the diagnosis or
treatment of mental illness, so long as all other billing requirements
are met. However, clinical social workers, marriage and family
therapists, and mental health counselors cannot directly bill Medicare
for caregiver training 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.
Comment: Commenters requested clarification of the minimum amount
of time of caregiving training that must be furnished to report the
code.
Response: Caregiver training services are treated the same as most
other timed services, and the full-time listed in the code descriptor
is required.
Comment: Commenters recommended that CMS avoid creating duplicative
caregiver training HCPCS codes and instead work with the AMA to
consider revisions to CPT coding. Other commenters suggested we work
with CPT to create simpler caregiver training codes or re-create
current coding to be more inclusive of different types of caregiver
training services.
Response: We understand the desire from commenters for simpler
coding for caregiver training. However, we also understand the
immediate needs of beneficiaries for varying types of caregiver
training services that are not currently represented by CPT coding. CMS
is available to meet with the CPT Editorial Panel and the AMA to
provide input and feedback regarding caregiver training CPT coding for
future code creation or editing. Until then, we believe that it is
paramount for patients to have appropriate access to these types of
services through the creation of HCPCS G codes.
b. Caregiver Assessment
In response to interested parties' requests for assessment of a
caregiver's knowledge to be included in caregiver training, we
clarified 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 proposed 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 also proposed
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 sought comment on these proposals and clarifications.
We received public comments on these proposals. The following is a
[[Page 97818]]
summary of the comments we received and our responses.
Comment: Some commenters supported our clarifications that CPT code
96161 can be used to determine if caregiver training services are
needed. Commenters were also supportive of our proposed consent
requirements and proposed adoption of the definition of ``caregiver''.
Response: We thank commenters for their input. We clarify that a
caregiver is not required to have a caregiver-focused health risk
assessment to participate in caregiver training services.
After consideration of public comments, we are finalizing as
proposed.
c. Proposals and New Coding
(A) Proposed Direct Care Caregiver Training Services
i. Coding
We proposed 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 proposed three new HCPCS codes: G0541 (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), G0542 (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 G0542 in
conjunction with G0541)), and G0543 (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 caregiver training that is already being separately billed
for patients under home health plan of care, receiving at-home therapy,
or receiving DME services for involved medical equipment and supplies.
We sought 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 solicited
public comment on each of our proposals for direct care CTS.
We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: Commenters were generally supportive of the creation of
these codes.
Response: We thank commenters for their support.
Comment: One commenter requested to use the term ``pressure
injury'' as opposed to ``decubitus ulcer'' in these code descriptors.
Response: We thank commenters for their input and would like to
note that the term ``decubitus ulcer'' is included in the code
descriptor only as an example, and caregiver training for the broader
term ``pressure injuries'' would be permitted when reasonable and
necessary, as CMS uses both terms.
Comment: One commenter requested that we specify that these direct
care caregiver training services are ``not billable for patients
receiving durable medical equipment (DME) services for medical
equipment and supplies,'' although surgical dressings are part of
DMEPOS equipment and related supplies. The commenter also requested
that we clarify the definition of DME services and how wound dressings
are involved in those services.
Response: We seek to avoid potentially duplicative payment for
services that are already paid for as part of another Medicare benefit
such as the Medicare Part B benefit for durable medical equipment (DME)
or the Medicare Part B benefit for surgical dressings. Payment to
suppliers of DME items such as drug infusion pumps includes payment for
supplies associated with use of the pump, such as wound dressings at
the catheter site. DME suppliers are required to train the beneficiary
or caregiver on use of supplies necessary for the effective use of the
infusion pump, such as the dressings at the catheter site. Likewise,
payment to suppliers of dressings covered under the Part B benefit for
surgical dressings includes payment related to training the beneficiary
or caregiver on how to use the dressings, including how to change them
correctly.
However, we would also like to clarify that the goal of paying for
the
[[Page 97819]]
direct care CTS for beneficiaries with wounds includes training related
to all aspects of wound care, such as how to properly change dressings,
use of different ointments, turning the patient to prevent pressure.
Therefore, we are revising the direct care CTS code descriptors to
replace the words ``wound dressing changes'' with ``wound care.'' We
are finalizing the direct care CTS code descriptors to read:
G0541 (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 care, and
infection control) (without the patient present), face-to-face; initial
30 minutes);
G0542 (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 care, and
infection control) (without the patient present), face-to-face; each
additional 15 minutes (List separately in addition to code for primary
service) (Use G0542 in conjunction with G0541)); and
G0543 (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 care, and
infection control) (without the patient present), face-to-face with
multiple sets of caregivers)).
Comment: Some commenters requested that we remove the restriction
for patients under home health plans of care, receiving at-home
therapy, or receiving DME services for unrelated conditions.
Response: We agree with commenters that caregiver training may be
appropriate for circumstances where a beneficiary's caregiver needs
training, but the patient is under a home health plan of care,
receiving at-home therapy, or receiving DME services for unrelated
conditions. CTS would not be billable for caregiver training that is
already being separately billed for patients under a home health plan
of care, receiving at-home therapy, or receiving DME services for
involved medical equipment and supplies. We seek to avoid potentially
duplicative payment. We would not expect the caregiver population
receiving these services on behalf of the patient to also receive CTS
on behalf of the patient under another Medicare benefit category or
Federal program.
Comment: Some commenters requested that we recognize that RDNs may
provide CTS for special diet preparation.
Response: Registered dieticians (RDs) and nutrition professionals
may only furnish direct care CTS when they identify a need to involve
and train one or more caregivers to assist the patient in carrying out
a patient-centered care plan for medical nutrition therapy (MNT)
services. Medical nutrition therapy services are defined in section
1861(vv) of the Act as nutritional diagnostic, therapy, and counseling
services for the purpose of disease management which are furnished by a
RD or nutrition professional pursuant to a physician's referral. Under
sections 1861(s)(2)(V) and 1861(vv) of the Act, RDs and nutrition
professionals are limited to billing for MNT services they furnish to
individuals with diabetes or a renal disease who meet certain specified
criteria. This limitation would also apply to direct care CTS. In
addition, because CTS are furnished outside the patient's presence, the
RD or nutrition professional must obtain the patient's (or
representative's) consent for the caregiver to receive the direct care
CTS. Like other CTS, 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.
Comment: Some commenters requested that these services would be
designated as ``sometimes therapy'' services.
Response: We are designating direct care CTS as ``sometimes
therapy'' services to facilitate payment for CTS under the PFS for
outpatient physical therapy, occupational therapy, and speech-language
pathology services when personally furnished by PTs and OTs, including
those provided by their supervised assistants as appropriate, as well
as the CTS personally furnished by SLPs. This means, as we stated in
the CY 2024 PFS final rule (88 FR 78920) for the other CTS codes, that
the services described by these codes are always furnished under a
therapy plan of care when provided by PTs, OTs, and SLPs; but, in cases
where they are appropriately furnished by physicians and NPPs outside a
therapy plan of care, that is, where the services are not integral to a
therapy plan of care, they can be furnished under a treatment plan by
physicians and NPPs.
Comment: Many commenters requested that we add examples, such as
caregiver training for home dialysis and rare disease treatments,
describing other types of direct care to these code descriptors.
Commenters also recommended working with interested parties to develop
further examples.
Response: The examples of health conditions for which direct care
CTS might be appropriate were not intended to be exhaustive. We
acknowledge that there are many circumstances under which direct care
CTS may be reasonable and necessary to train a caregiver who assists in
carrying out a treatment plan.
After consideration of public comments, we are finalizing the
following code descriptors: G0541 (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
care, and infection control) (without the patient present), face-to-
face; initial 30 minutes), G0542 (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
care, and infection control) (without the patient present), face-to-
face; each additional 15 minutes (List separately in addition to code
for primary service) (Use G0542 in conjunction with G0541)), and G0543
(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 care, and infection control)
(without the patient present), face-to-face with multiple sets of
caregivers)). We are also finalizing that caregiver training may be
appropriate for circumstances where a beneficiary's caregiver needs
training, but the patient is under a home health plan of care,
receiving at-home therapy, or receiving DME services for unrelated
conditions. In addition, we are finalizing that G0541, G0542, and G0543
are designated as ``sometimes therapy'' services. All other details for
these codes are being finalized as proposed.
ii. Valuation
For G0541, we proposed 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,
[[Page 97820]]
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 G0541. CPT code 97550 has an
intraservice time of 30 minutes, and the physician work is of similar
intensity to our proposed HCPCS code G0541. Therefore, we proposed a
work time of 30 minutes intraservice time (40 minutes of total time)
for HCPCS code G0541 based on this same crosswalk to CPT 97550. We also
proposed to use this crosswalk to establish the direct PE inputs for
HCPCS code G0541.
For G0542, we proposed 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 G0542. CPT code 97551 has an intraservice time of
17 minutes, and the physician work is of similar intensity to our
proposed HCPCS code G0542. Therefore, we proposed a work time of 17
minutes for HCPCS code G0542 based on this same crosswalk to CPT 97551.
We also proposed to use this crosswalk to establish the direct PE
inputs for HCPCS code G0542.
For G0543, we proposed 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 (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
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 G0543. CPT code 97552 has an
intraservice time of 9 minutes, and the physician work is of similar
intensity to our proposed HCPCS code G0541. Therefore, we proposed a
work time of 9 minutes intraservice time (14 minutes total time) for
HCPCS code G0543 based on this same crosswalk to CPT 97552. We also
proposed to use this crosswalk to establish the direct PE inputs for
HCPCS code G0543.
We sought comment on supplies/equipment that would be typical for
the newly created direct care strategies and techniques CTS codes.
We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: Commenters pointed out that the proposed rule
inadvertently referred to HCPCS codes GCTD1-3 in this section as GCTM1-
3.
Response: We would like to thank commenters for pointing out this
inadvertent drafting error. These codes are corrected above with the
code descriptors for HCPCS codes G0541-G0543.
After consideration of public comments, we are finalizing the code
descriptors for direct care caregiver training services, as described
by HCPCS codes G0541-G0543.
Comment: Some commenters supported our valuation for HCPCS codes
G0541-G0543. We did not receive comments discussing specific supplies
and equipment that would be typical for these codes.
Response: We thank commenters for their input on the valuation of
HCPCS codes G0541-G0543.
After consideration of public comments, we are finalizing as
proposed.
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 proposed 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 sought comments on these proposals.
We received public comments on these proposals. Please refer to
section II.D. for a summary of the comments we received and our
responses.
(B) Individual Behavior Management/Modification Caregiver Training
Services
i. Coding
We proposed 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
proposed two new HCPCS codes: G0539 (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 G0540 (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 G0540 in conjunction with G0539)).
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 sought comment on these proposals.
We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: Commenters generally supported our proposals to establish
HCPCS codes G0539 and G0540. We received some comments requesting the
[[Page 97821]]
creation of broader caregiver training codes in the future.
Response: We thank commenters for their input, and we may consider
commenters' recommendations for future rulemaking.
After consideration of public comments, we are finalizing HCPCS
codes G0539 and G0540 as proposed.
ii. Valuation
For HCPCS code G0539, we proposed 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 G0539. CPT code 97550 has an intraservice time of
30 minutes, and the physician work is of similar intensity to our
proposed HCPCS code G0539. Therefore, we proposed a work time of 30
minutes intraservice time (40 minutes of total time) for HCPCS code
G0539 based on this same crosswalk to CPT 97550. We also proposed to
use this crosswalk to establish the direct PE inputs for HCPCS code
G0539. We sought comment on supplies/equipment that would be typical
for the newly created individual behavior management/modification CTS
codes.
For HCPCS code G0540, we proposed 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 G0540. CPT code 97551 has an intraservice time of
17 minutes, and the physician work is of similar intensity to our
proposed HCPCS code G0540. Therefore, we proposed a work time of 17
minutes for HCPCS code G0540 based on this same crosswalk to CPT 97551.
We also proposed to use this crosswalk to establish the direct PE
inputs for HCPCS code G0540.
We sought comment on supplies/equipment that will be typical for
the newly created individual behavior management/modification CTS
codes.
We believe these services will largely involve contact between the
billing practitioner and the caregiver through in-person interactions,
which could be conducted via telecommunications as appropriate.
Therefore, we proposed 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 sought comments on these proposals.
We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: Some commenters supported our valuation for HCPCS codes
G0539 and G0540. In addition, a few commenters supported a crosswalk to
CPT code 90832 (Psychotherapy, 30 minutes with patient), as commenters
stated this was a more analogous code. We did not receive comments
discussing specific supplies and equipment that would be typical for
these codes.
Response: We continue to believe that a crosswalk to CPT codes
97550 and 97551 are most appropriate for valuation of HCPCS codes G0539
and G0540, as these codes match closely in time and intensity. In an
effort to maintain relativity within the caregiver training code
family, we believe this crosswalk is appropriate.
After consideration of public comments, we are finalizing as
proposed.
(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 proposed that consent for CTS can be provided verbally by the
patient (or representative). This will 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 will 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 sought comment on this proposal.
We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: Commenters were supportive of our proposal to allow verbal
consent for caregiver training services.
Response: We appreciate commenters' input.
After consideration of public comments, we are finalizing as
proposed.
(D) Addition to Telehealth List
Please see section II.D. of this final rule, Payment for Medicare
Telehealth Services, for the outline related to proposals to add CTS to
the Medicare Telehealth list.
(41) 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
[[Page 97822]]
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 issued 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 sought 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 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 proposed to clarify
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 received public comments on this proposal. The following is a
summary of the comments we received and our responses.
Comment: Commenters overwhelmingly supported of this clarification.
Response: We thank commenters for their input.
We are finalizing our clarification as proposed.
We requested 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
[[Page 97823]]
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 sought 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 also sought 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 also solicited 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 recognized
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 sought comments on ways to identify specific services and to
recognize possible barriers to improved access to these kinds of high-
value, potentially underutilized services by Medicare beneficiaries.
We sought 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 referred 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 proposed new coding in other sections of this CY 2025 final 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.L. of this final rule and the advanced primary
care management codes in section II.G.2 of this final 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 global postop add-on code could
help resolve these issues.
We received public comments on this RFI. The following is a summary
of the comments we received and our responses.
Comment: A few commenters responded to our RFI for fracture-related
care. Overall, commenters agreed that care is commonly fragmented in
osteoporosis and post-fracture care. Some commenters stated that
services like APCM, GPOC1 (G0559), CHI, or PIN do not accurately
describe fracture liaison services. Other commenters said that the
initiating visits for CHI and PIN may be a barrier to care. Similar to
general feedback we received for CHI and PIN, commenters requested that
initiating visits be furnished retroactively, meaning that during care
transitions, CHI or PIN services could begin, as long as the initiating
visit occurs within 30 days of discharge.
Response: We thank commenters for their feedback and may consider
these recommendations and requests for future rulemaking. We clarify
that for billing PIN services, there are circumstances in which
osteoporosis may be considered 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.
Comment: Commenters provided many examples of services and service
elements that may not be described in current coding, as well as
information about how CBOs are currently working with practitioners to
furnish these services.
Response: We thank commenters for providing further information
about how CHI, PIN, and SDOH risk assessment services are currently
being used and how these services could be improved in the future. We
will consider this information for future rulemaking.
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[[Page 97856]]
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 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 proposed to refine our current
policy for services furnished beginning in CY 2025. We proposed 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 welcomed comments on this
proposal.
We received many public comments on this proposal. The following is
a summary of the comments we received and our responses.
Comment: Many commenters supported our proposal and encouraged CMS
to finalize as proposed. They stated that there are inherent costs of
building trust in the practitioner-patient relationship, which is
particularly important when making decisions about administering
immunizations and other Medicare Part B preventive services, and that
these inherent costs are reflected in the valuation of the O/O E/M
visit complexity add-on code.
Response: We agree and thank commenters for their support of this
proposal.
Comment: A few commenters opposed our proposal and questioned
[[Page 97857]]
the need for the O/O E/M visit complexity add-on code based on
arguments similar to those made in prior years. Those in opposition
stated that our proposed policy would result in unnecessary payments if
finalized because the O/O E/M visit complexity add-on code itself is
ill defined and the O/O E/M visit code set is appropriately valued.
Response: We refer the commenters to the CY 2024 PFS final rule (88
FR 78972) where we discussed similar concerns regarding duplicative
payment when the O/O E/M visit complexity add-on code (HCPCS code
G2211) is billed with an O/O E/M visit. We continue to believe that the
values we established for the revised O/O E/M CPT codes in the CY 2021
PFS final rule did not fully account for the resource costs associated
with primary care and certain types of specialty visits (85 FR 84569).
However, those values were finalized in concert with separate payment
for HCPCS code G2211 which accounted for the resource costs associated
with those types of visits (87 FR 69588).
Comment: A few commenters recommended that CMS allow the O/O E/M
visit complexity add-on code (HCPCS code G2211) to be reported
alongside other CPT codes, such as those describing other E/M visits
furnished to beneficiaries in other settings of care including nursing
facilities, assisted living facilities and the patient's home.
Commenters explained that home-based primary care practices provide
access to primary care services for patients who otherwise would not be
able to leave the house to see a primary care practitioner, and include
the development of longitudinal, ``high-touch'' relationships with
their patients.
Response: We appreciate that practitioners who provide home-based
primary care services may furnish E/M visits in an individual's home or
residence that contribute to the development of longitudinal
relationships with those patients. Commenters focused on how
practitioners who furnish E/M visits to patients in homes or
residences, nursing facilities, and assisted living facilities develop
longitudinal relationships with their patients just as practitioners do
in the office or outpatient setting. Whereas the values we established
for the revised O/O E/M CPT codes in the CY 2021 PFS final rule were
finalized in concert with separate payment for HCPCS code G2211 (85 FR
84569, 87 FR 69588), we finalized work RVUs for the nursing facility E/
M visit codes (87 FR 69604 through 69606) and the home or residence
services code family (87 FR 69608 and 69609) subsequently in the CY
2023 final rule. Nevertheless, we may consider in future rulemaking
whether home or residence evaluation and management services bear
unrecognized resource costs and whether HCPCS code G2211 should be
applicable to home or residence E/M visits.
Comment: Many commenters recommended that in addition to the AWV,
immunizations and preventive services, we finalize that payment for the
O/O E/M visit complexity add-on code (HCPCS code G2211) can be made
when the following services are reported by the same billing
practitioner on the same day as HCPCS code G2211: an echocardiogram or
other cardiovascular imaging procedure, occipital nerve block via
injection, nebulizer treatment, ambulatory continuous glucose
monitoring (CGM), Transitional Care Management (TCM), and spirometry or
inhalation device education. These commenters stated that as these
services are part of long-term, longitudinal relationships with
patients who are often extremely complex and require extensive
evaluation, HCPCS code G2211 captures the additional work of treating
these patients. Other commenters stated that certain specialists, such
as endocrinologists, typically see sicker patients than primary care
practitioners and to the extent that other services (beyond O/O E/M
visits and preventive services) are furnished to these patients they
should also be billable alongside HCPCS code G2211.
Other commenters stated that we should continue to explore the
appropriateness of restricting billing of HCPCS code G2211 to O/O E/M
visits not billed with the payment modifier -25. These commenters
stated that even if the visit is being reported in conjunction with
another service, there still may be resource costs associated with
longitudinal care that are not reflected in the payment for the O/O E/M
visit or the other service.
Other commenters recommended that, rather than refine our billing
policies to allow HCPCS code G2211 to be billable alongside O/O E/M
visits with modifier -25, that we prohibit concurrent billing with
codes in the surgical section of the CPT Codebook (CPT codes 10000-
69999), or allow billing of HCPCS code G2211 with O/O E/M visits
reported with modifier -25 during a global period if the global period
has >0% designated to pre or post operative care.
Many commenters also requested clarification as to whether HCPCS
code G0402 (Initial Preventive Physical Exam (IPPE)) was included as a
preventive service billable alongside HCPCS code G2211.
Response: We note that the application of the add-on code is not
based on the characteristics of particular patients (even though the
rationale for valuing the code is based on recognizing the typical
complexity of patient needs), but rather the relationship between the
patient and the practitioner (88 FR 78973). In part, HCPCS code G2211
recognizes the inherent costs of building trust in the practitioner-
patient relationship that are not reflected in the valuation of the O/O
E/M code set. As we discussed in the proposed rule, building trust as
part of a longitudinal practitioner-patient relationship may be
particularly significant in the context of preventive services, and for
this reason, we believe it is appropriate to limit billing of HCPCS
code G2211 to preventive services at this time. However, we do
acknowledge the points raised by commenters about other similar
services and may consider broadening the applicability of HCPCS code
G2211 through future rulemaking.
Regarding reporting HCPCS code G2211 alongside O/O E/M visits with
modifier -25, we continue to believe as we stated in the CY 2024 PFS
final rule, that separately identifiable O/O E/M visits occurring on
the same day as minor procedures (such as zero-day global procedures)
have resources that are sufficiently distinct from the costs associated
with furnishing stand-alone O/O E/M visits to warrant a different
payment policy, and as such, we finalized that the O/O E/M visit
complexity add-on code, HCPCS code G2211, is not payable when the O/O
E/M visit is reported with payment modifier -25 (88 FR 78971). We may
consider additional changes to this policy for future rulemaking. We
responded to comments that suggested alternative policies and that
suggested exemptions for specific codes, including codes that would
fall within the range of CPT codes 10000-69999 referenced by one of the
commenters on the CY 2025 PFS proposed rule. We believed the
alternatives offered by commenters could increase administrative burden
with minimal benefit gained and unnecessarily delay reactivation of the
complexity add-on code and payment (88 FR 78974-78975). We would need
more time to evaluate the potential policy implications and systems
changes associated with a prohibition on concurrently billing HCPCS
code G2211 with codes in the surgical section of the CPT Codebook (CPT
codes 10000-69999) or allow billing of HCPCS code G2211 with O/O E/M
visits
[[Page 97858]]
reported with modifier -25 during a global period if the global period
has >0% designated to pre or post operative care.
We appreciate commenters' recommendations for additional services
to be included in the refined policy for the O/O E/M visit complexity
add-on code that we proposed to apply for the AWV, vaccine
administration, and Part B preventive services furnished in the office
or outpatient setting. While we did not propose and are not adding
other services to our refined policy for the O/O E/M visit complexity
add-on code in this final rule, we are confirming that the IPPE, also
known as the ``Welcome to Medicare'' preventive visit is included in
our proposed policy because it is a Part B preventive service furnished
in the office or outpatient setting.
Comment: Several commenters requested that we provide detailed
medical necessity requirements and documentation guidelines related to
reporting HCPCS code G2211.
Response: In response to interested party feedback requesting
guidance about medical necessity and documentation requirements, we
posted frequently asked questions at https://www.cms.gov/files/document/hcpcs-g2211-faq.pdf. As we stated in this document, we have
not specified any additional medical record documentation requirements
for reporting HCPCS code G2211. Our medical reviewers may use the
medical record documentation to confirm the medical necessity of the
visit and the patient care relationship as appropriate. We would expect
that information included in the medical record or in the claims
history for a patient/practitioner combination, such as diagnoses, the
practitioner's assessment and medical plan of care, and/or other codes
reported could serve as supporting documentation for billing HCPCS code
G2211. Practitioners should consult their Medicare Administrative
Contractor (MAC) regarding documentation requirements related to the
underlying O/O E/M visit.
After consideration of public comments, we are finalizing as
proposed to allow payment of the O/O E/M visit complexity add-on code
(HCPCS code G2211) when the O/O E/M base code (CPT 99202-99205, 99211-
99215) is reported by the same practitioner on the same day as an AWV,
vaccine administration, or any Medicare Part B preventive service.
G. Enhanced Care Management
1. Background
As described in the CY 2025 Medicare Physician Fee Schedule (PFS)
proposed rule, 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.\24\
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\24\ 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 PFS statute at section 1848 of the Act, we establish
payment amounts for covered physicians' services, and update our
payment policies to address changes, including changes in medical
practice. In the CY 2025 PFS proposed rule, we proposed 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 (89 FR 61596). Specifically, we proposed 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.'' \25\ Using this definition, we proposed to recognize the
resources involved in furnishing services using an ``advanced primary
care'' approach to care under the PFS \26\ (89 FR 61596). 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).\27\ 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
[[Page 97859]]
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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\25\ 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.
\26\ 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/.
\27\ 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 proposed 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 for a patient. This new 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),\28\ Comprehensive Primary Care Plus (CPC+),\29\ and Primary
Care First (PCF) 30 31 to inform the elements upon which the
delivery of APCM services under an advanced primary care delivery model
depend. As detailed in this final rule, this 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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\28\ https://www.cms.gov/priorities/innovation/innovation-models/comprehensive-primary-care-initiative.
\29\ https://www.cms.gov/priorities/innovation/innovation-models/comprehensive-primary-care-plus.
\30\ https://www.cms.gov/priorities/innovation/innovation-models/primary-care-first-model-options.
\31\ 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 were 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 included an Advanced Primary Care Hybrid Payment
Request for Information (RFI) (Advanced Primary Care RFI) in the
proposed rule. The Advanced Primary Care RFI sought 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 our goal of having 100 percent of
Traditional Medicare beneficiaries in accountable care relationships by
2030.\32\
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\32\ 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 final rule
also recognizes physician and practitioner work that draws from
evidence generated by the CMS Innovation Center's Million
Hearts[supreg] model.\33\ 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.\34\ We proposed 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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\33\ https://www.cms.gov/priorities/innovation/innovation-models/million-hearts-cvdrrm.
\34\ 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 G0556,
G0557, and G0558)
a. Background
We described in the CY 2025 PFS proposed rule that 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.\35\ Research has
demonstrated that greater primary care physician supply is associated
with improved population-level mortality and reduced disparities,\36\
and also, that establishing a long-term relationship with a primary
care provider leads to reduced emergency department (ED) visits,\37\
improved care coordination, and increased patient satisfaction.\38\ 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
final 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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\35\ 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.
\36\ 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.
\37\ 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/.
\38\ 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
final 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
[[Page 97860]]
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, 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, 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) 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-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 final
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 proposed 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 described in the CY 2025 PFS proposed rule that we have
prioritized
[[Page 97861]]
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 have incorporated into our policies.
Several CMS Innovation Center models address payment for care
management services and CTBS. The CPC initiative,\39\ the CPC+
model,\40\ and the PCF model \41\ all included payments for care
management services that closely aligned with the care management
services included in the PFS. In these initiatives and models, 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 the 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.\42\ 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.\43\ Table 23 identifies a
number of CMS Innovation Center models and key care delivery methods
from each.\44\
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\39\ https://downloads.cms.gov/files/cmmi/CPC-initiative-fourth-annual-report.pdf.
\40\ https://www.cms.gov/priorities/innovation/data-and-reports/2023/cpc-plus-fifth-annual-eval-report.
\41\ Evaluation of the Primary Care First Model. February 2024.
https://www.cms.gov/priorities/innovation/data-and-reports/2024/pcf-second-eval-rpt.
\42\ 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.
\43\ 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.
\44\ 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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[GRAPHIC] [TIFF OMITTED] TR09DE24.054
We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: Commenters overwhelmingly supported the proposed coding
and payment policies to recognize APCM services under this specific
model of advanced primary care, making use of lessons learned from the
CMS Innovation Center's testing of advanced primary care models. Most
commenters expressed gratitude that separate payment could be available
for services they had already been furnishing, and many commenters
appreciated our goal to address the perceived gap in payment for care
management and coordination for patients without multiple chronic
conditions. Many commenters appreciated the proposed shift away from
time-based payment and thanked us for acknowledging that primary care
needs often change month to month. Several commenters supported our
proposals' emphasis on technology integration and commitment to the
evolving healthcare landscape, highlighting the importance of virtual
interactions for better patient-centered care. A few commenters were
concerned that our proposed APCM coding and payment would duplicate
work described by the existing CCM and PCM codes, potentially creating
confusion and administrative burden. One commenter suggested we
collaborate with the AMA's CPT Editorial Panel on coding or revise
existing CCM and PCM codes to reduce burden and simplify requirements.
Many commenters recommended that cost sharing be eliminated for the
proposed APCM services, indicating that any amount of cost sharing
could be prohibitive to receiving beneficiary consent, ultimately
limiting the uptake of and billing for APCM services. A few commenters
suggested that APCM services are preventive services that should be
exempt from beneficiary cost sharing. Several commenters indicated that
cost sharing had limited their ability to bill for other care
management services, resulting in their underutilization. A few
commenters stressed that it can be difficult to educate beneficiaries
on the value of care management services and the associated cost
sharing because the patient is not ordinarily present when APCM
services are performed. Finally, one commenter believed that the
application of cost sharing could exacerbate existing health
inequities.
Response: We thank the commenters for their support and feedback.
We anticipate that these services will fill a need in primary care and
care management, and result in more accurate payment for advanced
primary care under the PFS. While we recognize concerns about potential
confusion with CCM and PCM, APCM codes are essential for improving
payment accuracy and enabling practitioners to spend more time with
patients. We look forward to reviewing and considering, including
through potential future rulemaking, any recommendations from the AMA's
CPT Editorial Panel and RUC if they consider developing CPT codes and
recommending valuations for these or similar services.
In response to the comments regarding elimination of beneficiary
cost sharing for APCM services, most services covered under Medicare
Part B carry cost sharing obligations (deductible and co-payment)
unless the statute specifies that they do not apply. As for considering
APCM services to be ``preventive services'' to which cost sharing does
not apply, we do not see how APCM services would fit within any of the
benefit categories for preventive services under the Act at this time.
In particular, the Secretary has the authority to add ``additional
preventive services'' that, among other things, have been assigned an
``A'' or ``B'' rating by the United States Preventive Services Task
Force. But APCM services have not earned such a rating at this time.
Since APCM services do not currently meet the criteria for ``additional
preventive services,'' we cannot designate them as such under section
1861(s)(2)(BB) of the Act or remove coinsurance obligations on that
basis at this time. Further, we do not have other statutory authority
that would allow us to remove or waive the applicable cost sharing for
APCM services.
b. Proposed HCPCS G-Codes for Advanced Primary Care Management (APCM)
We proposed in the CY 2025 PFS proposed rule to establish coding
and make payment under the PFS for a newly defined set of APCM services
described and defined by three new
[[Page 97864]]
HCPCS G-codes. To recognize the resource costs associated with
furnishing APCM services to Medicare beneficiaries, we proposed 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.\45\ It will 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 outlined in section II.G.2.a.(1) in
this final 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, 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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\45\ 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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In the CY 2025 PFS proposed rule, we explained the proposed new
codes and their descriptors (89 FR 61596), we proposed to define the
elements of the scope of service for APCM that will be required for a
practitioner to bill Medicare for the APCM service, and we explained
the 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 final rule). We proposed 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 identified the services that
we proposed will overlap substantially with the new codes and which
will not be separately billable with the APCM codes under our proposal
(see section II.G.2.d. of this final rule). Finally, we proposed to
establish relative values for these codes for purposes of payment under
the PFS (see section II.G.2.e. of this final rule).
We proposed the following G-codes and descriptors for APCM
services, and as explained in section II.G.2.d. of this final rule, due
to the similar scope of APCM and other care management and CTBS
services, we proposed to include some of the same language from the CCM
and PCM service elements in the APCM code descriptors, as well as
emphasized that certain practice capabilities and requirements are
inherent in these elements and must be met in order to bill for APCM
services:
HCPCS code G0556 (Advanced primary care management services
provided by clinical staff and directed by a physician or other
qualified health care professional who is responsible for all primary
care and serves as the continuing focal point for all needed health
care services, per calendar month, with the following elements, as
appropriate:
Consent;
++ Inform the patient 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.
[[Page 97865]]
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 G0557 (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 G0556, as appropriate) and HCPCS code G0557
(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 G0556, as appropriate).
We proposed that HCPCS codes G0556 through G0558 would describe
APCM services furnished per calendar month, following the initial
qualifying visit (see section II.G.2.c.(1) for more on the initiating
visit). Physicians and NPPs, including nurse practitioners (NPs),
physician assistants (PAs), certified nurse midwives (CNMs) and
clinical nurse specialists (CNSs), could bill for APCM services. As we
describe in more detail in section II.G.2.c., within the code
descriptors for HCPCS codes G0556, G0557, and G0558, we proposed to
include the elements of the scope of service for APCM as well as the
practice capabilities and requirements that are 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 in section II.G.2.e.(1) of this final
rule, within the code descriptors for HCPCS codes G0556, G0557, and
G0558, we proposed 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
anticipated 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, there are
situations when care is provided by a practitioner who would not serve
as ``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 proposed that HCPCS codes G0556, G0557, and
G0558 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 (89 FR 61596).
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
[[Page 97866]]
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 implementing
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 sought feedback from
interested parties on methodologies that could allow for identification
of the beneficiary's primary care practitioner. We also sought comment
on whether there should be additional requirements to prevent potential
care fragmentation or service duplication.
We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: We received a few comments regarding the types of
practitioners that can furnish and be paid for APCM services. These
interested parties thanked us for including advanced practice nurses
such as nurse practitioners, certified nurse midwives, and clinical
nurse specialists. Several commenters encouraged us to add additional
types of health care professionals to those who can furnish APCM, such
as registered nurses and pharmacists.
Response: We thank the commenters for their feedback. We appreciate
the value of interdisciplinary teams, which can include registered
nurses and pharmacists. As discussed later in this rule, APCM services
can be furnished by the types of Medicare-enrolled practitioners that
are authorized under the statute to furnish and be paid for services
performed by auxiliary personnel (which can include registered nurses
and pharmacists) incident to their own professional services. We
proposed to add APCM services as designated care management services
under Sec. 410.26(b)(5), which means that these services can be
performed by auxiliary personnel under the general supervision of the
billing physician or other practitioner. As defined under Sec.
410.26(a)(3), general supervision means the service is furnished under
the physician's (or other practitioner's) overall direction and
control, but the physician's (or other practitioner's) presence is not
required during the performance of the service, whereas direct
supervision in the office setting means the physician (or other
supervising practitioner) must be present in the office suite and
immediately available to furnish assistance and direction throughout
the performance of the service.
Comment: A few commenters asked how to identify the practitioner
responsible for the patient's primary care, giving an example of a
patient who has a primary care practitioner and a geriatrician. Other
commenters supported our proposed definition of primary care
practitioner as the individual responsible for the patient's primary
care and who serves as the continuing focal point for all needed health
care services, with one stating that such a practitioner would
understand the history and context of each patient. Another commenter
agreed with our proposed approach to identifying the appropriate
practitioner for purposes of billing for APCM services, as it is
tailored toward those practitioners who provide consistent,
longitudinal care rather than those who provide more time-limited,
discrete services. We did not receive any comments about patient-
practitioner relationships not indicative of a primary care
relationship.
Response: We appreciate the commenters' support for our proposed
approach to identifying the primary care practitioner responsible for
the patient's care. We recognize that a patient may regularly see
multiple practitioners, and that more than one of them may be in a
specialty that is generally considered to furnish primary care, as in
the example provided by the commenter of a patient who sees their
primary care practitioner and a geriatrician. While more than one
practitioner may have an ongoing relationship with the patient, there
ordinarily would be only one of them who serves as the continuing focal
point for all needed health care services. We proposed that the patient
must be informed as part of the required beneficiary consent before
receiving APCM services that only one practitioner can furnish and be
paid for these services during a calendar month. We believe that any
lack of clarity as to which practitioner serves as the continuing focal
point for all care can be resolved through the beneficiary consent
process and with clear and comprehensive patient education.
Comment: A few commenters indicated it may be useful to use a
beneficiary's attestation of their main health care practitioner on
Medicare.gov to identify who could bill for APCM services.
Additionally, some commenters suggested that we should develop a
claims-based attribution method similar to that used by the Shared
Savings Program or CMS Innovation Center models to determine the
responsible primary care practitioner.
Response: We thank the commenter for this suggestion. We
acknowledge that an attribution method that uses historical claims data
and/or beneficiary attestations made through Medicare.gov could be
useful to reduce the administrative burden on practitioners in
determining whether they are the appropriate primary care practitioner
for purposes of APCM services. Given that these are new services, we
believe it would be more appropriate to refrain from implementing
additional requirements so that we may consider feedback from
interested parties as they gain experience billing for these services.
We may consider additional guardrails to prevent the submission of APCM
claims from more than one practitioner through possible future
rulemaking. Finally, as we discussed in the CY 2021 final rule related
to monitoring appropriate use of the E/M visit complexity add-on code
(HCPCS code G2211), we believe that information included in the
patient's medical record or claims history could serve as supporting
documentation to help us determine whether the billing physician or
practitioner is the appropriate primary care practitioner for purposes
of APCM services (85 FR 84571). We would like to remind commenters that
only one practitioner can bill for APCM services per month, which
should be discussed when obtaining the patient's consent for these
services.
Comment: We received many comments about the specialties of the
practitioners we would expect to furnish and bill for APCM services. A
few commenters were split on whether specialists should be permitted to
bill for the APCM codes, with some commenters recommending that
specialists who might tend to serve in the role of primary care
practitioner, such as cardiologists, endocrinologists, and
pulmonologists should be allowed to bill for APCM services. Other
commenters stated that even specialists who have long-term
relationships with patients are unlikely to provide advanced primary
care services as envisioned in our proposed APCM codes, and expressed
concern that allowing them to bill for APCM services could lead to
fragmented care.
[[Page 97867]]
Response: We understand the commenters' concerns about fragmented
care, especially across specialists and primary care practitioners. Our
aim in developing proposals to identify the appropriate practitioner to
furnish and bill for APCM services was to retain flexibility to allow
for the specific circumstances of individual practitioners and
beneficiaries. We reiterate as described before that a specialist who
manages one or more of a patient's serious conditions is not
necessarily the practitioner who is responsible for all of the
patient's primary care and the focal point for all needed health care,
which is specified in the code descriptors as the basis for a
practitioner to furnish and bill for APCM services. In the event that a
specialist and a primary care practitioner both intend to be
responsible for all primary care services and serve as the focal point
of all needed care for the same patient, we note that we proposed to
make payment to only one practitioner for APCM services in any single
month. Further, we proposed that the patient must be informed of this
as part of the required patient consent before receiving APCM services.
We believe that the question of which practitioner should furnish and
bill for APCM services for a patient can be resolved through clear and
comprehensive patient education, as well as communication between
practitioners if needed.
Comment: Several commenters agreed with our proposed coding
structure of monthly billing for APCM. A few other commenters agreed
that a monthly billing cycle strikes a balance between the number of
times these services are furnished annually and monthly payment.
Response: We thank commenters for their support. We continue to
believe that billing APCM each calendar month is the most appropriate
billing cadence.
After consideration of public comments, we are finalizing our
proposals without modification to create three G-codes to describe APCM
services effective January 1, 2025, which can be billed monthly
following the initiating qualifying visit (see section II.G.2.c.(1) for
more on the initiating visit) by the physician or practitioner (nurse
practitioner, physician assistant, certified nurse midwife, or clinical
nurse specialist) who intends to be responsible for the patient's
primary care and serve as the continuing focal point for all needed
health care services. We are not limiting APCM services to
practitioners in specific specialties, but we remain open to feedback
about these policies from interested parties.
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
proposed that APCM services will 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 received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: Commenters were overwhelmingly supportive of our proposal
to include APCM as a designated care management service, including
support for our proposal to allow general supervision of auxiliary
personnel for these services.
Response: We thank commenters for their support.
After consideration of public comments, we are finalizing our
proposal to add APCM services as a ``designated care management
service'' under Sec. 410.26(b)(5) and, as such, these services can be
provided by auxiliary personnel under the general supervision of the
billing practitioner.
Unlike the other coding to describe care management services, we
further proposed that the code descriptors for HCPCS codes G0556,
G0557, and G0558 would not be time-based (89 FR 61596). 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), physicians and practitioners
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 will not meet the
requirements for billing the PCM service. We also noted that, unlike
the current coding to describe certain CTBS services, we proposed that
the code descriptors for HCPCS codes G0556, G0557, and G0558 will 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 CY 2019 PFS final rule, we have heard
from interested parties that the timeframe restrictions for billing
certain CTBS are administratively burdensome (83 FR 59686).
We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: Most commenters were overwhelmingly supportive of our
proposal to not require the counting of clinical staff minutes spent
furnishing APCM services to reach specific time-based thresholds for
billing the proposed APCM codes, noting that doing so is both
administratively burdensome and often results in practitioners
providing services that they are unable to bill and be paid for because
they do not reach the required minimum time threshold to bill for a
service. One commenter applauded this proposal and asserted that, in
time-based billing scenarios, the need to
[[Page 97868]]
maintain a certain rate of billable units across the patient population
to keep the program financially tenable may directly or indirectly
incentivize care managers to prioritize activities that fulfill billing
requirements and deprioritize needed activities for patients who may
need intervention but have already fulfilled the billing requirements
or are unlikely to fulfill the billing requirements. A few commenters
expressed concern that removing the time-based thresholds may
inadvertently incentivize over-billing of the proposed APCM codes, in
which a practitioner bills the APCM codes for beneficiaries whether or
not they are performing any of the APCM service elements, such as care
coordination.
Response: We agree with the commenters who suggested that
practitioners delivering care using an advanced primary care approach
are providing ongoing care management and coordination services for
their patients. While these activities should be documented in the
patient's medical record, we agree that the need to document clinical
staff minutes spent providing these services is unnecessarily
administratively burdensome in the context of advanced primary care,
and that the requirement to meet time-based thresholds is not necessary
to bill the APCM codes (HCPCS codes G0556, G0557, and G0558) as we
proposed to define them. While we appreciate the concern about over-
billing, we believe that practitioners that meet all of the other
requirements to bill HCPCS codes G0556, G0557, and G0558, and are
documenting the care management and coordination services they are
furnishing to patients in the medical record without recording the
clinical staff minutes spent on each activity, are providing medically
necessary advanced primary care management services. We reiterate that,
while only one physician or practitioner may furnish and be paid for
APCM services for a patient in a single month, a patient's other health
care providers can furnish and bill for other care management services,
such as TCM, CCM, PCM, CHI, PIN, and certain CTBS, when medically
necessary. Additionally, we recognize that there may be some
practitioners who do not furnish care using the advanced primary care
model or prefer to bill using other care management codes rather than
the new APCM codes. We note that, like all other physicians' services
billed under the PFS, each of these services must be medically
reasonable and necessary to be paid by Medicare.
Comment: Most commenters were supportive of not including the same
time-based restrictions on billing other services that apply for CTBS
in the code descriptors for HCPCS codes G0556, G0557, and G0558.
Commenters also suggested that it is not always possible to adhere to
the current restrictions on billing for certain CTBS services,
including 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, despite a practitioner's best efforts to do so.
Response: We agree that the time-related billing restrictions that
apply for certain CTBS services (for example, virtual check-in
services) are not necessary for HCPCS codes G0556, G0557, and G0558. We
adopted the limitations on when certain CTBS can be billed with other
codes to avoid duplicative payment. For example, in the case of virtual
check-in services, which are a brief exchange with a practitioner to
determine whether the patient needs to be seen or the problem can be
addressed in a different way, payment for a contemporaneous E/M service
would already reflect the resources involved in furnishing the virtual
check-in service. However, in the case of virtual check-ins provided as
part of APCM services, there is no need for such limitations because
the APCM codes describe a broad set of advanced primary care services--
not all of which will be provided in any particular month.
After consideration of public comments, we are finalizing our
proposal without modification to establish APCM codes and descriptors
that reflect all elements of service furnished during a month without
specifying the amount of time that must be spent furnishing the
services during the month; and without including time-related billing
restrictions for the elements of the services.
We also proposed 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 (89 FR 61596). 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 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 (G0557) 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 proposed 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 the CY 2025 PFS proposed rule (89 FR 61707), 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, using our previous example of the patient with heart
failure and chronic kidney disease receiving Level 2 APCM services, if
the patient 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 proposed that specific minutes spent furnishing APCM
services for purposes of billing HCPCS codes G0556-G0558 need not be
documented in the patient's medical record, we will expect that any
actions or communications that fall within the APCM elements of service
will be described in the medical record and, as appropriate, their
relationship to the clinical problem(s) they are intended to resolve
and the treatment plan, just as
[[Page 97869]]
all clinical care is documented in the medical record.
We sought feedback on these service descriptions as part of the CY
2025 PFS proposed rule, on whether there are elements of other care
management services that should be removed or altered for purposes of
APCM services. We have summarized comments on our proposed service
descriptions on section II.G.2.c. for Level 1, Level 2, and Level 3
APCM. 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 proposed
that the APCM codes will 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
proposed that the new APCM coding schema will 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) \46\ with two or more chronic conditions
(``Level 3'') (see Table 24 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 will 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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\46\ 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 recognized the ways in which this new APCM coding
intersects with current care management codes around number of chronic
conditions (89 FR 61596). 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 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).
[GRAPHIC] [TIFF OMITTED] TR09DE24.055
We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: We received many public comments on our proposed APCM
service code levels, some of which we have summarized in section
II.G.2.e(1) where we discuss Level 1, Level 2, and Level 3 APCM
services. In general, the majority of commenters appreciated our
efforts to stratify the APCM codes based on patient complexity and
resource intensity, recognizing the importance of addressing the needs
of patients with varying levels of chronic conditions. Furthermore,
many commenters were supportive of the proposal not to require all
elements of the APCM services to be furnished each month in which APCM
is billed, expressing appreciation for our acknowledgment that
beneficiaries' needs will vary from month to month.
However, several commenters generally believed the proposed
stratification may not fully account for the severity of individual
conditions or appropriately account for the resource costs for
beneficiaries with multiple complex conditions and recommended various
alternatives for stratification. Several commenters suggested that our
proposed APCM levels are inappropriately weighted towards
uncomplicated, lower-risk patients and were concerned that the proposed
stratification does not reflect the additive impact of multiple chronic
conditions, or the increased resources associated with furnishing APCM
services to higher-risk patients with complex illness. Some of these
commenters suggested that there are a significant number of Medicare
beneficiaries with more than two chronic conditions and, as the number
of chronic condition increases, the types of support and time needed to
manage these patients increases. Specifically, several commenters
encouraged us to add an additional level to the APCM service codes to
account for patients with significant clinical complexity and
healthcare needs that do not meet QMB criteria, but who still require
intensive resource utilization. A few commenters suggested that six
chronic conditions would be an appropriate threshold. Other commenters
recommended that a fourth tier be added to the APCM
[[Page 97870]]
service code levels based on the high needs beneficiary criteria from
the High Needs track of the ACO REACH Model to account for the
resources needed to support patients with complex illness. These
commenters suggested that this criterion has been effective at
identifying high-cost, high-needs patients and would allow us to
incorporate another successful element of value-based care into
traditional Medicare payment policy.
Response: We thank all commenters for their careful consideration
of the proposed approach to stratify the APCM codes, and we appreciate
commenters' suggestions for specific types of beneficiaries who may
require intensive care management resource utilization and warrant an
additional APCM code level, including beneficiaries with complex
illness. We appreciate commenters' suggestion to consider the high
needs beneficiary criteria from the High Needs track of the ACO REACH
model. The model's eligibility criteria for alignment to a High Needs
Population ACO includes beneficiaries with one or more conditions that
impair mobility or neurological condition, significant chronic or other
serious illness reflected by risk score and unplanned hospital
admissions, or signs of frailty (who may also be dually eligible or at
risk of becoming dually eligible).\47\ We also acknowledge commenters'
concerns that patients with two chronic conditions may require
additional time and more complex care than a patient with two chronic
conditions and QMB status. However, we believe that beneficiaries who
are QMBs face unique challenges outside chronic condition management
that may impact their care, requiring additional care management
resources. We believe that our proposed APCM code stratification
recognizes that individual beneficiaries have unique and varying
resource needs, and strikes a balance between being overly specific in
the creation of many categories, which could increase confusion and
administrative burden, and being overly simplistic, which could
inadequately differentiate between variations in the resources involved
in furnishing APCM services. We believe that our proposal does this in
an appropriate way and, as such, are finalizing the code stratification
as proposed. However, we continue to welcome feedback to help us
consider possible future changes to our policy and will take
commenters' suggestions into consideration as we consider the
development of proposals for future rulemaking.
---------------------------------------------------------------------------
\47\ For PY2025, CMS expanded these criteria to include
beneficiaries that have at least 90 Medicare-covered days of Home
Health services utilization or at least 45 Medicare-covered days in
a Skilled Nursing Facility within the previous 12 months. The
revised eligibility criteria were expected to more effectively
identify beneficiaries with complex needs that would benefit from
participation in a High Needs Population ACO. More information
available at https://www.cms.gov/priorities/innovation/media/document/aco-reach-rfa and https://www.cms.gov/priorities/
innovation/innovation-models/reach-py24-model-
perf#:~:text=The%20model's%20eligibility%20criteria%20for,admissions%
2C%20or%20signs%20of%20frailty.
---------------------------------------------------------------------------
Comment: A few commenters recommended that we review the AMA RUC
Medical Home Workgroup's valuation recommendations from 2008 where they
described services defined in the Medicare Medical Home demonstration
project.\48\ For context, in 2008, pursuant to the Tax Relief and
Health Care Act of 2006 (Pub. L. 109-432), we conducted a three-year
demonstration project to evaluate the medical home model of patient
care. We drafted a three-tiered system to categorize medical homes
based on the capabilities of the physician practices serving in that
capacity for purposes of conducting the demonstration project. We asked
the RUC for their assistance in creating possible valuations for these
three tiers, including costs associated with physician work, direct
practice expense, and professional liability insurance. These
requirements ranged from entry-level practices to fully integrated,
complex health systems, and which took into consideration varying
practice-level capabilities, such as electronic prescribing
capabilities, documentation of referral histories, and maintenance/
service contract for hardware, internet, etc. These commenters
suggested that we adopt the RUC's 2008 valuation recommendations as a
framework for APCM services and establish APCM levels based on these
medical home practice tiers.
---------------------------------------------------------------------------
\48\ American Medical Association. (n.d.). Medical home model of
care: Recommendations (Publication No. 0). AMA. https://www.ama-assn.org/sites/ama-assn.org/files/corp/media-browser/public/rbrvs/medicalhomerecommend_0.pdf.
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Response: We have reviewed the RUC's 2008 recommendations for code
descriptors, physician work, direct practice expense inputs, and
professional liability insurance crosswalks for each of the three tiers
of medical homes and found that the recommended tier system and payment
based on practice-level capabilities would not fully capture the policy
goals of the proposed APCM coding and payment. The proposed APCM codes
were built on a presumed set of practice capabilities that reflect the
use of an advanced primary care model of care delivery, which has been
increasingly common in medical practice, and valued to more accurately
account for the resources involved in furnishing care using an advanced
primary care model. While we have never addressed in rulemaking the AMA
RUC's findings and recommendations for the medical home practice tiers
and associated valuations, we acknowledge that several practice-level
capabilities described by the RUC are similar to the proposed APCM
service elements, including but not limited to obtaining consent, care
planning, acting as the primary focal point of care, and 24/7 access.
However, our proposal to adopt coding for APCM was to recognize the
shift in medical practice toward care delivery using an advanced
primary care model and improve payment for care management services
delivered by practitioners who have adopted an advanced primary care
approach, which involves a specific set of practice-level capabilities.
Stratifying coding for APCM services based on practice-level
capabilities would not be helpful to that purpose. And there is other
available coding that recognizes the resources involved in care
management services furnished by practitioners outside of an advanced
primary care model. We are also concerned that stratifying levels of
payment for APCM services based on practice-level capabilities, rather
than patient-level characteristics, could further exacerbate inequities
in health systems, including smaller or rural practices who may furnish
care to equally complex patients as compared to larger, more
established health systems and clinics.
Finally, we do not believe the valuation proposed in the RUC's
recommendation can be appropriately applied to the proposed APCM code
levels. The RUC suggested a work RVU per patient per month of 0.35 for
Tier 3 in the medical home model, which was intended for ``very sick''
patients. The recommended 0.35 RVU is lower than the highest valuation
for APCM. If we had adopted the RUC's recommended RVUs for the three
tiers, we would have reduced our proposed values for the APCM codes,
which would not have appropriately reflected the resources involved in
furnishing these services.
After consideration of public comments, we are finalizing as
proposed the APCM service code levels.
(1) Level 1 APCM
We proposed 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
[[Page 97871]]
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 (89 FR 61596). 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.\49\ 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.
---------------------------------------------------------------------------
\49\ 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.
---------------------------------------------------------------------------
We received many public comments on our proposed APCM service code
levels. The following is a summary of the comments we received and our
responses.
Comment: Most of the commenters recommended that we adopt
additional codes to provide differential payment for more and less
complex beneficiaries. Many commenters were concerned that the proposed
stratification is heavily weighted towards uncomplicated, lower-risk
patients. A few commenters pointed out that some patients with a
single, but very serious condition, may require significantly more
resources than patients with multiple chronic conditions that are
stable or less severe. By focusing solely on the number of chronic
conditions, commenters suggested that this stratification could
overlook the nuanced differences in resource needs based on condition
severity and complexity. Many commenters recommended that we further
evaluate and refine the stratification scheme to more accurately
reflect the resource intensity required for effective advanced primary
care delivery by incorporating additional factors, such as the severity
of individual conditions, social risk factors beyond QMB status, and
other indicators of medical complexity. Several commenters recommended
that we create an add-on code for QMBs that could be reported with any
of the APCM levels, including Level 1. These commenters stated that it
is likely that there are many beneficiaries with two or fewer chronic
conditions that have social risk factors that may impact their care.
These commenters provided the example of an otherwise healthy
beneficiary who has found themselves newly homeless, leaving them at
greater risk for contracting infections and illnesses, which impacts
their overall care.
Response: We believe that all beneficiaries, even with a small
number of chronic conditions, can benefit from care coordination and
access to advanced primary care services. We also recognize that a
patient's health conditions may change rapidly, and having established
ongoing care can mitigate and reduce negative health outcomes. We
appreciate that the number of chronic conditions a beneficiary has may
not correlate perfectly to the severity or complexity of illness.
However, as noted earlier in this discussion, we are aiming to strike a
balance between coding specificity and administrative simplicity to
appropriately stratify APCM services based on how chronic medical
conditions interact with increased risk associated with social
determinants of health (SDOH) factors. We understand that there will
always be beneficiaries within a particular APCM code level whose needs
for APCM services are greater or less than other beneficiaries. We
expect the adoption of coding and payment policies for APCM services to
be an iterative process, informed by ongoing feedback from interested
parties that we will take into consideration for future rulemaking.
Comment: One commenter stated that the code descriptor for HCPCS
code G0556 does not mention the presence of a chronic condition, while
the risk stratification for billing the code states ``patients with one
or fewer chronic conditions.'' This commenter therefore requested that
we include ``patients with one or fewer chronic conditions'' in the
code descriptor for enhanced clarity. Another commenter asked us to
clarify what constitutes a ``chronic condition'' for purposes of APCM
service level selection, and whether we would use an approach similar
to CCM in which we do not enumerate an exhaustive list of conditions
that qualify for CCM payment, instead defining a qualifying condition
as one that is ``expected to last at least 12 months or until the
patient's death and or that place them at significant risk of death,
acute exacerbation and or decompensation, or functional decline.''
Response: We agreed with the commenters that we should add
clarifying language to the code descriptor for Level 1 APCM services.
We are finalizing modifications to our proposed code descriptor for
Level 1 APCM services to indicate the presence of one or fewer chronic
conditions that are ``expected to last at least 12 months or until the
patient's death and or that place them at significant risk of death,
acute exacerbation and or decompensation, or functional decline.'' We
point out to commenters that we had already included this definition of
``chronic condition'' for Level 2 and Level 3 APCM services.
After consideration of public comments, we are finalizing the code
descriptor for HCPCS code G0556 as: HCPCS code G0556 (Advanced primary
care management services for a patient with one chronic condition
[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], or fewer, provided
by clinical staff and directed by a physician or other qualified health
care professional who is responsible for all primary care and serves as
the continuing focal point for all needed health care services, per
calendar month, with the following elements, as appropriate:
Consent;
++ Inform the patient 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,
[[Page 97872]]
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 with typical
care plan elements when clinically relevant;
++ 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.).
(2) Level 2 APCM
We proposed 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.\50\ 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 will
furnish APCM services may have already had experience with care
management services coding and payment for much of this population.
---------------------------------------------------------------------------
\50\ 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.
---------------------------------------------------------------------------
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.
Comment: One commenter recommended that we add a modifier to be
reported with the Level 2 APCM code to reflect social complexity and/or
additional medical complexity for non-QMB beneficiaries.
Response: We thank commenters for their consideration of the
proposed Level 2 APCM service, and we appreciate the commenter's
suggestion for potential ways to recognize that non-QMB beneficiaries
may also have increased needs associated with social and/or medical
complexity and therefore require more resources regardless of their QMB
status. However, we believe that our proposed coding approach
appropriately balances coding specificity with administrative
simplicity. We continue to welcome feedback to help us evaluate the
appropriateness of the APCM service levels, coding structure, and our
social risk adjustment methodology, and we will consider possible
changes to our policy in future rulemaking.
After consideration of public comments, we are finalizing as
proposed the code descriptor for HCPCS code G0557:
HCPCS code G0557 (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
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
[[Page 97873]]
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.).
(3) Level 3 APCM
We proposed 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 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 proposed 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; \51\ for example, dually eligible beneficiaries are
more likely to have poor functional status \52\ 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.\53\
---------------------------------------------------------------------------
\51\ 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(.
\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\ https://www.macpac.gov/wp-content/uploads/2024/01/Jan24_MedPAC_MACPAC_DualsDataBook-508.pdf.
---------------------------------------------------------------------------
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.\54\ For
the approximately 8.5 million dually eligible beneficiaries who are
QMBs, Medicaid covers 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 our approval to disregard certain income and
assets.\55\ Beneficiaries apply for this benefit with their State's
Medicaid program and must be redetermined eligible at least annually.
---------------------------------------------------------------------------
\54\ 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.
\55\ 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,\56\ such that social risk
[[Page 97874]]
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.\57\ 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.\58\ Dual enrollees, and more specifically, QMBs, are
therefore a category of Medicare beneficiaries who are 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 proposed 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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\56\ 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.
\57\ 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.
\58\ 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.\59\ We solicited comments from
States on how they would cover cost sharing for the proposed APCM
bundle, considering lesser-of policies.
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\59\ 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 also sought feedback on the use of QMB status and multiple (two
or more) chronic conditions as the basis to bill for APCM Level 3
(G0558), 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.
We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: Several commenters appreciated our recognition of social
risk as a factor in health outcomes and healthcare delivery and agreed
that beneficiaries with higher social risk have higher healthcare needs
but were concerned about our proposed use of QMB status as a proxy
indicator for patients with added social risk. A few commenters stated
that there is currently not a widely adopted or universal approach to
social risk adjustment and asserted that research has not shown dual
eligibility status to be sufficiently sensitive to capture all at-risk
beneficiaries. Multiple commenters encouraged us to broaden the
criteria to identify and address social risk for Level 3 and suggested
that we use additional data sources, including for example residence in
areas with high Area Deprivation Index scores, dual eligibility status,
and presence of unmet SDOH needs, to identify social risk.
Several commenters recommended that the requirements for Level 3
APCM include beneficiaries with at least one chronic condition and one
unmet SDOH need, regardless of their dual eligibility or QMB status.
Another commenter urged us to adjust payments to practitioners caring
for patients who experience not only greater medical complexity but
also greater social-emotional complexity, asserting that it is critical
that risk adjustment criteria account for health-related social needs
(HRSNs), including economic stability, education, social and community
life, one's neighborhood and access to high-quality health care.
A few commenters were concerned about practitioners' ability to
determine a patient's QMB status and were concerned about additional
operational burden. These commenters asserted that this will be a
significant obstacle to billing G0558 and were concerned that many
practices may have to bill G0557 if they cannot confirm a patient's QMB
status. Several commenters recommended that we use more readily
identifiable criteria, such as dual eligibility status. One commenter
stated that we should determine what level of APCM a beneficiary
qualifies for to reduce practitioner burden. A few commenters
recommended that we make use of existing Z-codes for SDOH (Z55-65) as
standard identifiers and make payment to practitioners when they ask
their patients about their SDOH to determine their patients'
eligibility for APCM Level 3.
Many other commenters supported the use of QMB status as an
appropriate indicator to identify beneficiaries with added social risk
and called it a ``good first approach'' for us and advanced primary
care practices to stratify the risk of Medicare beneficiaries to whom
they provide APCM services. One of these commenters suggested that
future risk stratification should identify other people in need of more
intensive APCM services, such as those with disabilities, those with
serious mental and other chronic illnesses, or those with
disproportionate use of potentially preventable acute care services.
Other commenters encouraged us to review findings of methodologies
tested in Innovation Center models, as well as to engage with payers
and policymakers to align on a common framework that incorporates a
broader understanding of social risk using validated data and
methodologies, and then incorporate their learnings into the APCM
framework.
[[Page 97875]]
Response: We thank commenters for their feedback. We reiterate our
view that QMB status is a good indicator for patients with higher SDOH
needs. As described in the CY 2025 PFS proposed rule (89 FR 61596), we
chose QMB status as the method to identify beneficiaries with SDOH
factors who may require relatively greater resources from practitioners
that furnish advanced primary care services due to the strong evidence
associated with dual eligibility for Medicare and Medicaid with poorer
outcomes in Medicare Value-Based Purchasing (VBP) programs, in addition
to the fact that we have QMB status in our administrative data (in
contrast to other SDOH data elements) as well as the lack of cost
sharing for QMBs.\60\ However, we acknowledge that there may be other
ways to identify patients with higher SDOH needs, including for example
residence in areas with high Area Deprivation Index scores, dual
eligibility status, and presence of unmet SDOH needs, and we intend to
consider possible additional or alternative methods through future
rulemaking, as appropriate.
---------------------------------------------------------------------------
\60\ 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.
---------------------------------------------------------------------------
We also appreciate the concerns some commenters raised about
practitioners' ability to use QMB status to determine patient
eligibility for Level 3 APCM services. However, we continue to believe
practitioners have access to this information when verifying a
patient's Medicare eligibility. Because all Medicare providers and
suppliers are prohibited from billing QMBs for Medicare cost sharing,
we have established mechanisms in place to help practitioners identify
QMB patients. The Medicare 270/271 HIPAA Eligibility Transaction System
(HETS) became effective in November 2017. Through HETS, health care
providers can determine QMB status for each patient prior to billing.
We also include QMB information in the Medicare Remittance Advice (RA)
for fee-for-service claims after claims processing. Practitioners
should consider asking their third-party eligibility-verification
vendors how their products reflect the QMB information in HETS. We also
recognize that, in some larger practices or practices that are part of
larger health systems, there may be administrative staff or billing
departments that have access to this information. For practitioners who
furnish services to QMBs, including those who plan to bill for Level 3
APCM services, it would be important to establish internal workflows to
ensure proper identification of patients with QMB status. Additional
information can be found at https://www.cms.gov/outreach-and-education/medicare-learning-network-mln/mlnmattersarticles/downloads/se1128.pdf.
Practitioners can also learn a patient's QMB status directly through
State Medicaid agencies. While States may use different methods for
verification, such as telephonic or electronic systems, the Medicaid
eligibility verification systems will confirm whether an individual is
covered as a QMB.
While we acknowledge the opportunities raised by several commenters
to use additional data sources to identify patients with likely social
risk, we believe that our proposal to use QMB status is evidence-based,
operationally feasible, and sufficiently sensitive to capture at-risk
beneficiaries that require additional resources. As such, are
finalizing the use of QMB status as proposed. However, as health
services research continues to evolve in identifying social risk, we
will continue to explore possible additional or alternative methods to
identify patients with social risk and modify coding and payment for
APCM services through future rulemaking as appropriate.
Comment: Several commenters recommended that we adopt a higher
intensity APCM code for seriously ill/high needs beneficiaries and
value this code to account for the higher resource costs involved in
delivering advanced primary care to patients with complex illness.
These commenters asserted that an additional APCM code level would
capture non-QMB patients with significant clinical complexity and
healthcare needs who require intensive APCM services and resource
utilization.
Response: We appreciate commenters' suggestion for potential ways
to recognize that non-QMB beneficiaries who are seriously ill may have
increased needs associated with medical complexity and therefore
require more resources. As we stated in response to comments on the
Level 1 and Level 2 APCM service levels, we believe that our proposed
coding approach and the specific recognition of QMBs in one code level
appropriately balances coding specificity with administrative
simplicity. We will continue to engage with interested parties to
assess the appropriate level of code stratification and will address
any potential refinements through future rulemaking.
After consideration of public comments, we are finalizing our
proposal to define Level 3 APCM services based on QMB status and two or
more chronic conditions. We will continue to evaluate the
appropriateness of the APCM service levels, coding structure, and
recognition of social risk. We are finalizing as proposed the code
descriptor for HCPCS code G0558: HCPCS code G0558 (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
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
[[Page 97876]]
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.).
c. APCM Service Elements and Practice-Level Capabilities
All the elements within the scope of APCM services are included in
the service descriptors for G0556, G0557, and G0558, listed in Table
26, and described in this section. We proposed in the CY 2025 PFS
proposed rule that APCM services will 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). This is appropriate because care management is
a key component of care delivery using an advanced primary care model.
The 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 sought to ensure that the APCM codes will fully and
appropriately capture the care management services and CTBS 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 proposed 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
final rule). As described in more detail in this section, we proposed
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 proposed to
specify timely follow-up during care transitions (see section
II.G.2.c.(6) of this final rule). For the ``Enhanced Communications
Opportunities'' APCM service element, we proposed 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 final rule).
We also proposed to specify for APCM services the practice-level
characteristics and capabilities that are 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 G0556, G0557, and G0558,
and listed in Table 26, are practice-level capabilities that reflect
care delivery using an advanced primary care model and are focused
around 24/7 access and continuity of care (see section II.G.2.c.(3) of
this final rule), patient population-level management (see section
II.G.2.c.(9) of this final rule), and performance measurement (see
section II.G.2.c.(10) of this final rule). These practice capabilities
are indicative of, and necessary to, care delivery using an advanced
primary care model. Further, APCM services, as we proposed 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 received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: Multiple commenters agreed that the proposed elements and
requirements reflect the services consistent with effective APCM and
these standards are consistent with current CMS primary care models and
demonstration projects. Several commenters supported aspects of the
proposal that crossed multiple APCM service elements--for example,
commenters expressed appreciation for the reference to caregivers in
four of the proposed elements (24/7 access and continuity of care,
patient-centered comprehensive care plan, management of care
transitions, and enhanced communications opportunities). Some
commenters suggested modifications, and several were concerned about
the volume and burden of requirements.
Other commenters were concerned that, while most practices may be
set up to deliver these services, certain primary care practices may
find it challenging to meet some of the proposed service elements. Some
commenters raised concerns that the practice-level capabilities will be
difficult for small or independent practices (and in some cases, health
centers) to meet and requested that that we modify certain practice-
level capabilities and APCM levels to account for varying levels of
practice infrastructure.
One commenter was particularly concerned about the inability of low
resource safety net providers--settings in which lower income
individuals and QMBs may receive their primary care, to meet these
standards, which could
[[Page 97877]]
potentially exacerbate disparities in care and payment for patients at
the highest risk. They asserted that without the ability to bill for
APCM services, safety net clinics will continue to face underpayment
for the important care they provide. The commenters stated that clinics
that do not meet the requirements to bill for APCM services, but still
deliver substantial care coordination, management, and advanced primary
care services to chronically ill beneficiaries with social risk--often
with limited resources to expand their capacity--are particularly
vulnerable to underpayment. For these reasons, some commenters
suggested that implementing tiered practice capability requirements
could address the current ``all or nothing'' approach, where there are
some practices that invest significant time and resources in
infrastructure to provide chronic care management but fall short of the
requirements to bill for APCM services, and then are ineligible for
payment for their currently uncompensated services.
Response: We appreciate commenters' feedback about the proposed
APCM service elements and practice-level requirements which are
reflective of the services consistent with care management in advanced
primary care. As we do for other care management services, we continue
to recognize the involvement of caregivers in health care for some
patients.
We also appreciate commenters' suggested modifications to certain
service elements and practice-level capabilities, and we acknowledge
several commenters' concerns about the volume and burden of
requirements. We welcome information on these issues from interested
parties and may consider revisions in future rulemaking.
We remain interested in the use of APCM services in settings such
as small practices and in rural and underserved areas, and we are
committed to identifying ways to increase access to primary care in
underserved communications. We also encourage practitioners who may not
meet all of the requirements to bill for APCM services to consider
whether the care coordination and management services they are
delivering would meet the requirements to bill for other care
management services such as TCM, CCM, PCM, CHI, PIN, or certain CTBS.
We will continue to identify and evaluate ways to encourage providers
to make APCM services available to all their patients in order to
support care improvement for underserved, high-risk beneficiaries.
We proposed that practitioners participating in the ACO REACH
Model, the Making Care Primary model, and the Primary Care First model
will satisfy the 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 25. 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
include risk stratification and quality and cost performance metrics
that are aligned or overlap with the ``Value in Primary Care'' Merit-
based Incentive Payment System (MIPS) Value Pathway (MVP).\61\ 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
also considered whether certain practitioners in other types of CMS
Innovation Center models also satisfy the service elements and
requirements and sought comments on this question.
---------------------------------------------------------------------------
\61\ See, for example, 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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We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: A number of commenters requested that we deem all ACO or
alternative payment model (APM) participants as satisfying all service
elements and requirements to bill the APCM codes by nature of their
participation in such a program. A few commenters questioned why
practitioners in ACOs would need to bill the APCM codes given that the
proposed service elements may overlap with ACO functions.
Response: We clarify 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 meeting requirements of their
model participation, and that we are not waiving any of the APCM
service elements or requirements for practitioners in these models or
the Shared Savings Program.
The one proposed practice-level requirement for APCM services that
is slightly different for these model participants and Shared Savings
Program participants than for other practitioners is the performance
measurement requirement. Because these models and the Shared Savings
Program require their participating practitioners to report on quality
and cost performance metrics that are aligned or overlap with the Value
in Primary Care MVP, we proposed that requiring these practitioners to
report the Value in Primary Care MVP for purposes of billing for APCM
services would be substantially duplicative. Our proposal would require
all other APCM service elements and practice-level capabilities to be
met and maintained in order for the model participants to bill for APCM
services. We simply noted that, for practitioners participating in the
ACO REACH Model, the Making Care Primary model, or the Primary Care
First model, many of the APCM service elements and practice-level
requirements would be met by meeting model participation requirements.
Similarly, practitioners participating in other APMs may, by meeting
requirements of their participation in the APM, meet some or all of the
APCM service elements and practice-level requirements; however, not all
APMs require reporting on quality and cost measures that align or
overlap with the Value in Primary Care MVP.
[[Page 97878]]
[GRAPHIC] [TIFF OMITTED] TR09DE24.056
[[Page 97879]]
[GRAPHIC] [TIFF OMITTED] TR09DE24.057
We sought comment on whether the proposed service elements and
practice-level requirements are appropriately reflective of care
management services for advanced primary care, and whether there are
elements of APCM services or practice capabilities that should be
modified or removed.
We also sought feedback on ways to align the APCM services with
other Medicare programs and initiatives, such as the Shared Savings
Program, the ACO REACH Model, and advanced primary care models, and the
Quality Payment Program, including MIPS and Advanced Alternative
Payment Models (Advanced APMs). We sought 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 noted that under the Quality Payment
Program, practitioners who are MIPS eligible clinicians will report
measures and activities as specified by us under the four MIPS
performance categories: quality, cost, improvement activities, and
Promoting Interoperability. To report to MIPS for a performance period
(Sec. 414.1320(i)) for the Promoting Interoperability 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 us and
submit required attestations as specified in Sec. 414.1375(b)(3).
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 as part of this final rule, we proposed 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 will already satisfy the APCM practice-level
requirements for Patient Population-Level Management (see section
II.G.2.c.(9) of this final rule), and performance measurement (see
section II.G.2.c.(10) of this final rule) by meeting separately
applicable participation requirements within the Shared Savings Program
and these APMs. As noted previously, we considered whether
practitioners in
[[Page 97880]]
other types of CMS Innovation Center models might also satisfy certain
APCM service elements and practice-level requirements through their
participation in the models and sought comments on this question. We
received public comments on these proposals. The following is a summary
of the comments we received and our responses.
Comment: We received a few comments recognizing our desire to
minimize duplicative reporting and the associated burdens, but no
specific suggestions to achieve this goal. Commenters did not directly
address the ways in which we may better align with other programs and
initiatives. Finally, commenters sought confirmation that practices
participating in either a Shared Savings Program ACO or Innovation
Center model will satisfy the performance measurement requirements.
Response: We thank commenters for their feedback and the request
for clarification. As described in the CY 2025 proposed rule and in
this final rule, we considered the burden associated with potentially
duplicative reporting requirements. Practitioners in practices
participating in a Shared Savings Program ACO or in certain Innovation
Center models (ACO REACH, Making Care Primary, Primary Care First) will
satisfy the performance measurement element of the APCM services by
meeting their respective program and model requirements.
(1) Beneficiary Consent
Consistent with other care management services, we proposed in the
CY 2025 PFS proposed rule 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 proposed 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 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 proposed 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 noted 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 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
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 sought feedback on these 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 it would
be helpful if we provided a template to facilitate patient consent.
We also sought feedback on whether we should require practitioners
to revisit consent for APCM services on an ongoing basis with patients.
We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: Most commenters were generally supportive of our proposal
to require consent. Many commenters felt that consent is important for
beneficiaries so they understand that cost sharing may apply for these
services on an ongoing basis. Several commenters requested
clarification on the frequency in which consent should be obtained, and
some commenters stated it should be obtained no more than once a year.
One commenter sought clarification if patients with an existing consent
for CCM would require a new consent for APCM. Commenters disagreed on
how consent should be obtained, with some requesting written consent to
be required, while others requested verbal consent to be allowed,
citing administrative burden of obtaining written documents. Another
commenter requested that we create a standardized consent form to be
used for APCM services. Others criticized consent requirements as an
administrative burden and stated that this burden is a substantial
barrier to uptake of current CCM and PCM codes.
Response: We thank commenters for their feedback. We appreciate
commenters' feedback about the potential operational difficulty of
obtaining and documenting consent. However, as discussed in the CY 2014
PFS final rule (78 FR 74424), we continue to believe that consent is
important to ensure beneficiaries understand their potential cost
sharing responsibilities, especially for non-face-to-face services. We
also encourage practitioners and practices to view the consent process
as an opportunity to educate the beneficiary about the new coding
Medicare has created for APCM services and discuss the service elements
and capabilities that make a practice qualified to perform these
services. This is also an opportunity to ensure that the beneficiary is
not receiving APCM services elsewhere, and as discussed in greater
detail later in this final rule, to ensure that the beneficiary
acknowledges and understands that this practitioner will serve as the
focal point of all primary care services until the beneficiary is no
longer receiving this type of care with this practitioner or practice.
For these reasons, we do not believe that a patient's previous consent
for CCM would be sufficient for purposes of the new APCM services, and
a beneficiary transitioning from CCM to APCM would require a new
consent.
After consideration of public comments, we are finalizing as
proposed that patient consent needs to be obtained at initiation of
APCM services and documented in the medical record. Written consent is
not necessary; however, practitioners may obtain written consent if
they wish. We are also clarifying that the patient consent must be
obtained to receive APCM services from the billing practitioner--which
would be the practitioner who intends to be responsible for all primary
care services and serve as the continuing focal point for all needed
health care services. A new consent to receive APCM services is
required if there is a change in the practitioner who furnishes and
bills for the APCM services, which is in line with consent
[[Page 97881]]
requirements for other care management services.
(2) Initiating Visit
Consistent with CCM services (CPT codes 99437, 99439, 99487, and
99489--99491) and PCM services (CPT codes 99424--99427), we proposed in
the CY 2025 PFS proposed rule 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 proposed 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.\62\ 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 proposed 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 proposed that
the initiating visit could be provided in person or as a Medicare
telehealth service.
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\62\ American Medical Association. CPT Professional 2024.
American Medical Association, 2023.
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We proposed that an initiating visit would not be required for
``established patients'' based on certain circumstances that
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. For patients with whom the
practitioner (or another in the same practice) has an established
relationship, there is not necessarily a need for an initiating visit
for APCM services; and we would not want to require an initiating visit
under circumstances where a visit may not be medically necessary. The
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 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, 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 noted that these standards would be consistent with applicable
Shared Savings Program and CMS Innovation Center patient attribution
standards in the ACO REACH Model, 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 will 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 establish 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 will 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 proposed certain exceptions to the
initiating visit requirement for APCM services, we noted 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 sought feedback on these 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
2 years) would be more appropriate.
We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: Commenters were overwhelmingly in favor of our proposals
not to require initiating visits for established patients, and
commenters agreed with the definitions proposed for established
patients. Commenters were also supportive of our proposal to include
Medicare telehealth visits or in-person visits as initiating visits.
One commenter suggested that including other specialist visits would
expedite patients into APCM. A few other commenters agreed with our
inclusion of the IPPE and stated that we should also include the
Medicare Annual Wellness Visit (AWV). We did not receive any comments
about the proposed inclusion of ACO and CMMI model participants as
established patients.
Response: We agree that initiating APCM services expeditiously is
important, but we disagree that an initiating visit could be provided
by a different practitioner than the practitioner furnishing APCM. APCM
coding describes services furnished by the specific practitioner who is
serving as the focal point of all health care for a patient, and we
continue to believe that the practitioner furnishing the initiating
visit should be the practitioner who will be furnishing the APCM
services. We thank the commenters for noticing that we did not include
the AWV in our proposal. This was an oversight, and we agree that the
AWV could serve as an initiating visit, so long as the practitioner
furnishing the AWV is a physician or other qualified health
professional such as a nurse practitioner, physician assistant,
clinical nurse specialist, or certified nurse midwife, as discussed
earlier in this final rule, and will be the same practitioner who will
furnish the APCM services.
After consideration of public comments, we are finalizing as
proposed that an initiating visit is required before a new patient
receives APCM services. We are finalizing our definition of a ``new
patient'' for this purpose as described in the CPT[supreg] 2024
Professional Edition Code Book on page 4, as a person who did not
receive any
[[Page 97882]]
professional services from the physician or other qualified health care
professional or another practitioner in the same group practice within
the previous 3 years.\63\ We are also finalizing that an initiating
visit is not required for established patients. We are finalizing our
definition of an ``established patient'' as (1) a beneficiary who has
been seen by the practitioner or another practitioner in the same
practice within the past three years or (2) a beneficiary who has
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 from the practitioner or another
practitioner in the same practice. We are also finalizing that
beneficiaries who are eligible to be assigned to an ACO because of an
established care relationship between the beneficiary and the billing
practitioner who will bill for APCM services and beneficiaries assigned
to a REACH ACO, or a Making Care Primary or Primary Care First practice
because of a similarly established care relationship are considered
established patients.
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\63\ American Medical Association. CPT Professional 2024.
American Medical Association, 2023.
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We are finalizing a modification to our proposal to specify that,
in addition to the initiating visit services we identified in the
proposed rule, the Medicare AWV can serve as an initiating visit, so
long as it is furnished by the practitioner who will furnish the APCM
services.
(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 proposed in the CY 2025 PFS
proposed rule to include for APCM services the same scope of service
elements we established for CCM and PCM services for 24/7 Access and
Continuity of Care with some modifications. For 24/7 Access to Care,
the scope of the service element we proposed 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.\64\
Depending on the type and setting of care, there are three components
of continuity that improve patient outcomes and experience: \65\
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.\66\ 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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\64\ 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.
\65\ 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.
\66\ 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 proposed 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
[[Page 97883]]
visits to best meet the patient population's needs, such as e-visits,
phone visits, home visits, and/or expanded hours. This 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 \67\) 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 did not propose
that a practice will 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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\67\ https://www.cms.gov/priorities/innovation/innovation-models/comprehensive-primary-care-plus.
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We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: Most commenters supported our 24/7 access to care
requirement for APCM services. One commenter stated that most practices
currently have this capability, reflected by the fact that physicians
with hospital privileges generally must demonstrate they have
continuous coverage for urgent patient needs. Several commenters
requested clarification on the 24/7 access to care requirement for APCM
services. A few commenters stated that providing 24/7 access to care is
very difficult due to physician shortage and burnout, as well as
certain practice arrangements that may limit real-time access to the
patient's electronic health information--for example, practices that
rely on a third party to provide after-hours call coverage. One
commenter urged us to support improvements in data-sharing
infrastructures, such as health information exchanges, which may help
alleviate some of these barriers.
Another commenter suggested that we should modify the requirement
for 24/7 availability. This commenter stated that depending on the hour
of the day, a reasonable amount of time should be allotted to respond
to patients, such as overnight when the practitioner should have time
to review the patient's charts before speaking to them. If this is not
possible, then a previously agreed-upon alternate should be allowed to
respond to the patient. Another commenter raised concerns about small
and independent practices in under-resourced settings that might not be
able to guarantee 24/7 access.
Commenters generally supported our continuity of care requirement
for APCM services and acknowledged the alignment of this requirement
with our proposal that APCM services are to be billed only by the
practitioner who intends to be the focal point for all needed health
care for the patient. One commenter was concerned about the lack of a
measure of continuity for accountability or evaluation as it relates to
the performance measurement requirement for APCM services and
recommended that we assess continuity as a measured outcome. This
commenter asserted that, with continuity, patient health outcomes are
improved across a wide range of chronic disease areas, including
diabetes, asthma, cancer, and dementia. Several commenters requested
clarification on the alternative visit requirement for APCM services,
including one commenter who asked whether the practitioner/care team is
required to offer home visits to bill for APCM services.
Response: We emphasize that our intent with this proposal was to
ensure that practices have flexibility in how they satisfy the
requirements, including how they ensure 24/7 access for urgent patient
needs. While we continue to believe that real-time access to patient
medical records is best for addressing after-hours care needs, we
understand this may not always be feasible, especially for smaller
practices that may rely on third parties for after-hours coverage.
Furthermore, we would like to reiterate that we did not propose to
require that a practice would need to regularly deliver care in all of
the alternative ways we mentioned, but instead that the practice would
provide care by some alternative means to traditional office visits as
appropriate to best meet their patient population's needs, including
but not limited to e-visits, phone visits, home visits, and/or expanded
in-person patient care hours.
Comment: Several commenters requested clarification on how to
document that a practice meets the 24/7 access to care requirement if a
patient receiving APCM services does not use after-hours care in a
given month, and asked if they would need to document in each patient's
medical record that the practice has 24/7 access to care.
Response: We do not expect that the practice level requirements
like 24/7 access to care would be documented in each patient's medical
records for each month for which APCM services are furnished, but we
would expect that if the patient had an interaction with a care team
member after hours, this would be documented in the patient's medical
record. By billing for APCM services, the practice is attesting that it
meets the requirements included in the code descriptor.
After consideration of public comments, we are finalizing the 24/7
access and continuity of care requirement as proposed, but with
clarification that 24/7 access for urgent needs means reasonable after-
hours care, when necessary, and with a modification that there need not
be real-time 24/7 access to the patient's medical record. Instead, we
will require that the after-hours responder must document and
communicate their interaction with the patient to the primary care
team/practitioner, and that interaction must be documented in the
patient's medical record. We are modifying the 24/7 access to care
requirement because we understand that real-time access to patient
medical records may not always be feasible, especially for smaller
practices that may rely on third parties for after-hours coverage. We
would like to reiterate that real-time access to the patient's medical
record is a key component of advanced primary care, and we may revisit
this issue in future rulemaking.
(4) Comprehensive Care Management
We proposed in the CY 2025 PFS proposed rule to adopt 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; 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
[[Page 97884]]
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) \68\ 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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\68\ 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.\69\ 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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\69\ 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 sought feedback on these requirements.
Comment: We received a few comments on this proposal, which were
overwhelmingly supportive. In particular, several commenters expressed
appreciation for our efforts to recognize that practices furnish
comprehensive care management by acknowledging the team-based aspect of
APCM which may help a patient navigate their complex health conditions.
Response: We thank the commenters for their support and are
finalizing the comprehensive care management service element as
proposed.
(5) Patient-Centered Comprehensive Care Plan
We proposed in the CY 2025 PFS proposed rule to adopt 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 proposed 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.\70\ 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 when applicable
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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\70\ 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
[[Page 97885]]
review; and when applicable, revision of the care plan (84 FR 62691).
We sought feedback on these requirements.
We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: Most commenters supported our proposed patient-centered
comprehensive care plan requirement for APCM services. Several
commenters requested clarification on the care plan requirement,
including whether existing CCM care plans meet the service requirements
and what our expectations are regarding updating the care plan at
``regularly defined intervals.'' One commenter also asked us to clarify
whether a member of the care team could initiate the care plan if they
sent it to the primary practitioner to edit and approve. One commenter
requested that we embed into the care plan the same requirements for
cultural and linguistic factors that we proposed in the practitioner,
home-, and community-based care coordination requirement for APCM
services. Another commenter requested that we create an additional code
for updating the care plan (in addition to HCPCS G0506, Comprehensive
assessment and care plan for patients with chronic conditions), with a
limit on billing it three times per year. One commenter encouraged us
to work with other agencies, stakeholders, and physicians to establish
clear, minimum requirements for EHR vendors that improve the process to
create, share, reconcile, and integrate multiple plans of care into a
comprehensive care plan. Other commenters agreed that all the required
care elements in the plans are necessary elements for care and should
be included in any final policy.
Response: We thank the commenters for their feedback. We are
clarifying that a member of the care team could draft the care plan, as
appropriate, and send to the practitioner for review and approval. We
appreciate the recommendation that cultural and linguistic factors be
included as a care plan requirement and remind commenters that the
typical care plan elements which are based on the those finalized in
the CY 2020 PFS final rule (84 FR 62691), are not limited to that list.
In the instance it is beneficial to the patient to include cultural and
linguistic factors in the care plan, the practitioner should be
empowered to add them. We intended that our definition of ``regularly
defined intervals'' match similar requirements for other care
management services, and thus are clarifying that the care plan should
be updated ``when applicable'' to match current requirements for CCM.
While it may be preferable, when feasible, to update the care plan on
an annual basis or more frequently, if there are relevant clinical
changes within that time, we believe that the need and frequency for
care plan revision should be considered as medically appropriate for a
particular beneficiary. We emphasize that our intent is to ensure that
practitioners have flexibility in how they can satisfy the care plan
requirement, and we do not wish to impose additional administrative
burden.
Comment: Some commenters stated that a ``comprehensive care plan''
is not needed when a practitioner is engaged in Level 1 APCM services
for a beneficiary with only one or no chronic conditions, and instead
suggested that the care plan requirement would be satisfied if the
practitioner maintains an up-to-date problem and medication list for
the patient, including the status of preventive services. A few
commenters recommended that care plans developed as part of the AWV
should satisfy the care plan requirement for APCM services. One
commenter was concerned about specific elements of the care plan that
might be too subjective--for example, expected outcome and prognosis.
Response: We emphasize that our intent is to ensure that
practitioners have flexibility in how they satisfy the care plan
requirement, including who drafts the care plan, what elements are
included, and as mentioned above, at what frequency they are updated.
We are sympathetic to commenters' concerns about this element,
especially in terms of current clinical practice and medical necessity
for less complex beneficiaries. While we are not requiring a specific
format for the care plan and, as described above, we provide a series
of typical care plan elements; we would like to emphasize that the need
for specific care plan elements should be considered as medically
appropriate for a particular beneficiary, which we also believe speaks
to the commenters' questions about the care plan for a level 1
beneficiary. We also agree with commenters that care plans developed as
part of the AWV by the same practitioner who furnishes APCM services
may be used to satisfy this requirement, as appropriate considering the
particular patient's clinical circumstances.
After consideration of public comments, we are finalizing the
patient-centered comprehensive care plan service element for APCM
services as proposed.
(6) Management of Care Transitions
We proposed in the CY 2025 PFS proposed rule to adopt for APCM
services the ``Management of Care Transitions'' service element we
established for CCM and PCM services with some modifications. Rather
than 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 proposed 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 also proposed to specify for the
``Management of Care Transitions'' APCM service element that the care
team/practitioner will follow up with the patient and/or caregiver
within 7 days after each ED visit and hospital discharge. This 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 \71\ 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 \72\), 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 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.\73\
[[Page 97886]]
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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\71\ https://www.cms.gov/priorities/innovation/files/x/cpcplus-practicecaredlvreqs.pdf.
\72\ https://www.cms.gov/priorities/innovation/innovation-models/making-care-primary.
\73\ 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.\74\ Such strategies are paramount for practices whose
patients may be contacting the practice with care needs that require
care team prioritization and urgent reply. We sought feedback on these
requirements.
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\74\ 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 received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: Several commenters were concerned about our proposed
management of care transitions requirement for APCM services, and
particularly the requirement for timely follow-up communication within
7 days of an ED visit or hospital discharge. A few commenters suggested
that we should modify the requirement for timely follow-up within 7
days of discharge because this is not always possible. One commenter
encouraged us to prioritize strategies designed to improve
interoperability to better coordinate care transitions. Another
commenter asked us to include pediatric-to-adult care transitions as
part of this requirement and they suggested that this type of
transition has a 6-month follow-up timeframe.
Response: We appreciate the perspective that interoperability
improvements could assist practitioners with managing care transitions,
and the feedback on pediatric-to-adult care transitions. We welcome
additional information from interested parties on these topics. We
emphasize that our intent with this proposal was to ensure that
practitioners furnishing APCM services have flexibility within their
practices as to how they satisfy the requirement, including how they
ensure timely follow-up after their patient's care transition. While we
understand that some patients and their caregivers may be difficult to
reach, we expect that practices make an active effort to timely follow
up with patients post-discharge. We would like to reiterate that we are
finalizing that a practice should meet this 7-day follow-up requirement
whenever possible.
After consideration of public comments, we are finalizing the
management of care transitions service element as proposed, but with
clarification that practitioners should make reasonable efforts to
provide timely follow-up communication after an ED visit or hospital
discharge within 7 days when possible. Consistent with other APCM
service elements, we will require that the efforts to reach the
patient/caregiver and any interaction must be documented in the
patient's medical record. Timely follow-up with patients after care
transitions is a key component of advanced primary care which we
believe will help achieve timely, seamless care across settings, and we
may consider revisions to this policy in future rulemaking.
(7) Practitioner, Home-, and Community-Based Care Coordination
We proposed in the CY 2025 PFS proposed rule 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 proposed to
specify that the ``ongoing communication and coordinating receipt of
needed services'' is 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 also proposed 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.\75\ 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
[[Page 97887]]
specialty practices and other care organizations, through a
collaborative care agreement, improves the process. Collaborative care
agreements often 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.\76\ 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 (83 FR 59687).
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\75\ 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.
\76\ 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 sought feedback on these
requirements.
We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: Most commenters were generally supportive of our proposal.
Several commenters expressed appreciation for the inclusion of cultural
and linguistic factors in the documentation requirements when
coordinating with and referring to services outside the primary care
clinic. One commenter was concerned that our proposals do not
incentivize specialists and other clinicians to coordinate with primary
care practitioners, recommending that we consider ways to encourage
clinicians to communicate and collaborate with each other. One
commenter was concerned that community-based aspect of care
coordination may pose challenges for certain primary care practices if
it extends beyond the routinely used home health services. For example,
lower income and QMB patients may receive their primary care in
practices that may not be able to meet these standards, such as low
resource safety net practices. The commenters stated that this could
potentially exacerbate disparities in care and payment for patients at
the highest risk.
Response: We thank the commenters for their support, and we agree
with commenters that specialists furnishing consultations in
conjunction with primary care practitioners are an essential element of
advanced primary care services. We are therefore clarifying in this
final rule that the interprofessional consultation codes (CPT codes
99446-99449 and 99451) can be billed concurrently with APCM services.
We note again that only one practitioner may furnish APCM services in a
month, so the consulting practitioner must not also furnish APCM
services to the same beneficiary. See Table 26. We believe that our
policy to allow concurrent billing of interprofessional consultation
codes and APCM services is responsive to commenters' concerns that our
proposals may not incentivize specialists and other clinicians to
coordinate with primary care practitioners. We appreciate the comments
about safety net practices and their ability to furnish APCM services.
As discussed previously in this final rule, we also encourage
practitioners in practices that may not meet all of the requirements to
bill the APCM codes to consider whether care management codes other
than the APCM codes might describe the services they are delivering
(for example, CCM, PCM, or certain other CTBS). Also as discussed
previously in this final rule, we will continue to identify and
evaluate ways to encourage practices and practitioners to make APCM
services available to all their patients in order to support care
improvement for underserved, high-risk beneficiaries.
After consideration of public comments, we are finalizing the
practitioner, home- and community-based care coordination service
element as proposed.
(8) Enhanced Communications Opportunities
We proposed in the CY 2025 PFS proposed rule to include for APCM
services the element of ``Enhanced Communications Opportunities'' we
established for CCM and PCM services with some modifications.
Specifically, we proposed to add ``internet and patient portal'' as
examples of asynchronous non-face-to-face consultation methods and
specify that the practitioner will 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
this will allow patients to access their usual source of care more
conveniently (see section II.G.2.c.(3) of this final rule). There is
growing consensus that incorporating telehealth into primary care will
allow patients to access their usual source of care more
conveniently.\77\ Patients using
[[Page 97888]]
telehealth visits have reported high satisfaction, identifying
convenience and perceived high quality of care as contributors,\78\
such that these may be a good alternative and, in some cases,
preferable to in-person communication.\79\ 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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\77\ 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.
\78\ 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.
\79\ 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 the CY 2025 PFS proposed rule, we
did not propose 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
sought feedback on these requirements.
We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: Many commenters supported the emphasis in our proposal on
technology integration and agreed that the bundling of CTBS with APCM
services demonstrates our overall commitment to adapting to the
evolving healthcare landscape, where virtual and asynchronous
interactions are becoming more prevalent. Several commenters agreed
with us that the integration of digital health technology into chronic
care management would enhance patient engagement, facilitate the
delivery of continuous, patient-centered care, and drive efficiencies
across the healthcare system. Some commenters asserted that this
approach would be particularly beneficial in enhancing care delivery in
rural and underserved areas, where access to specialized services may
be limited.
Another commenter recommended that we eliminate the requirement to
offer digital E/M services and virtual check-ins, since these may not
be appropriate for certain specialized populations--for example, some
home-bound patients may benefit from consistent face-to-face
interventions in the home.
Response: We take this opportunity to clarify that virtual check-
ins and digital online assessment and management and E/M visits (or e-
visits) are not specific requirements of this service element, but
rather, are listed as examples. We agree with commenters that
practitioners are in the best position to determine how their patients
interact with the practice and therefore are not requiring specific
types of encounters, but rather encouraging practices to consider ways
to ensure enhanced access to patient-initiated digital communications,
including but not limited to virtual check-ins and digital online
assessment and management and E/M visits (or e-visits).
Comment: Several commenters requested clarification on the
documentation required for this proposed service element and the degree
to which the primary care practitioner needs to be personally involved
in furnishing CTBS.
Response: With respect to whether the primary care practitioner
must be the individual in contact with the patient via any enhanced
communication methods, as described earlier in this discussion, many
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, and as designated care management
services could be provided by auxiliary personnel under the general
supervision of the billing practitioner. However, some services, such
as virtual check-ins or e-visits, necessarily involve the direct
delivery of care by the primary care practitioner. Furthermore, we
would not expect that the presence of enhanced communications
opportunities and capabilities would be documented in each patient's
medical record except to the extent that they are used to furnish APCM
services. Rather, if the patient has an interaction with a care team
member via an enhanced communication tool or service, we would expect
that interaction to be documented in the patient's medical record. By
billing for APCM services, the practitioner is attesting that the APCM
service meets the requirements specified in the code descriptor.
After consideration of public comments, we are finalizing the
enhanced communications opportunities service element as proposed.
(9) Patient Population-Level Management
We proposed in the CY 2025 PFS proposed rule to establish an APCM
service element for Patient Population-Level Management that will
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 proposed that all practices will 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 will offer additional interventions, as
appropriate.
These 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 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 those needs, and measure and improve the quality of care
and utilization of this subpopulation.'' \80\ 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.\81\ 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.\82\ Measurement of clinically relevant data at the
practice-
[[Page 97889]]
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.\83\ 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.\84\ 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.\85\ For
example, 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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\80\ CPC+ Care Delivery Resource. January 2019.
\81\ CPC+ Care Delivery Resource. January 2019.
\82\ 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.
\83\ https://www.cms.gov/priorities/innovation/files/x/cpcplus-practicecaredlvreqs.pdf.
\84\ 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.
\85\ 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 noted as part of the CY 2025 PFS 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.\86\ Participants in these models and their
practitioners are already engaged in population health management as
described in Table 25. We sought feedback on these requirements.
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\86\ 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 received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: One commenter stated that risk stratification and
population management will increase a practice's ability to deliver
care in the most efficient way possible. Another commenter stated that
population management could help practitioners reach underserved
populations. A few commenters indicated that the Patient Population-
Level Management and any associated data analysis could be completed by
the practice and did not necessarily need to be completed by the
practitioner. One commenter suggested that because practices have
different infrastructures, they should be allowed flexibility in how to
implement this requirement. A few commenters stated that they did not
believe patient Population-Level Management should be required to bill
APCM, and another commenter indicated it may be resource intensive for
small practices. One commenter requested that we develop an attribution
method by which we would help practitioners identify patients for which
they should conduct population management. Finally, one commenter
requested that we require practices to conduct Population-Level
management for the pediatric-to-adult referral population.
Response: As we indicated earlier, we agree that Population-Level
management can be beneficial for practices, assisting them with
addressing gaps in care. While Population-Level management requires the
development of a process to analyze data and assess gaps in care, we
believe that the standard we have proposed is broad enough to allow
practices the flexibility to develop and implement processes in a way
that best suits the needs of their practice and their patient
population, and in a manner that does not require significant start-up
costs. Furthermore, at this time, we do not believe it is necessary to
dictate for which patients a practice should conduct specific types of
Population-Level management. We did not propose that the Population-
Level management needed to be completed by the practitioner billing
APCM, and we agree with commenters that it is not necessary to require
the practitioner to conduct this work. Finally, we appreciate the
feedback that an attribution method may be useful for Population-Level
management and we may consider that topic for future rulemaking.
Comment: Several commenters requested clarification on how to
document that a practice meets the Patient Population-Level Management
requirement.
Response: As previously explained, we would not expect that the
practice-level requirements would be documented in each patient's
medical record except to the extent they are used in furnishing APCM
services to a specific patient, in which case we would expect the
service to be documented in the patient's medical record. For example,
if a practitioner calls a patient after a hospitalization and reviews
medication changes, a record of what transpired during that
conversation should be included in that patient's medical record. By
billing for APCM services, the practitioner is attesting that the
requirements included in the code descriptor have been met.
[[Page 97890]]
After consideration of public comments, we are finalizing the
``Patient Population-Level Management'' service element as proposed.
(10) Performance Measurement
We proposed, as part of the CY 2025 PFS, for the APCM services a
practice-level requirement for ``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,\87\ 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.\88\
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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\87\ https://www.ahrq.gov/patient-safety/quality-measures/21st-century/challenges.html.
\88\ https://www.cms.gov/priorities/innovation/innovation-models/comprehensive-primary-care-plus.
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We proposed that this practice-level Performance Measurement
standard could be met in several ways. For MIPS eligible clinicians,
the requirement would be met by registering for and reporting the
``Value in Primary Care'' MVP. A practitioner who is part of a TIN that
is participating in 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 meeting requirements under the Shared Savings
Program or CMS Innovation Center ACO REACH, Making Primary Care
Primary, or Primary Care First models. Because these models require
their participating practitioners to report on quality and cost
performance metrics that are aligned or overlap with the Value in
Primary Care MVP, we proposed that requiring these practitioners to
report the Value in Primary Care MVP for purposes of billing for APCM
services would be substantially duplicative.
In the CY 2024 PFS final rule (88 FR 80042 through 80047), we
finalized ``The Value in Primary Care'' MVP, which focuses on the
clinical theme of promoting quality care for patients in order to
reduce the risk of diseases, disabilities, and death. This MVP includes
certain cost measures, improvement activities, and quality measures for
common chronic conditions (for example, hypertension, diabetes,
depression).\89\ As with all MVPs, the Value in Primary Care MVP also
requires meaningfully using CEHRT and reporting the objectives,
measures, and attestations specified for the Promoting Interoperability
performance category.
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\89\ Value in Primary Care. Quality Payment Program. https://qpp.cms.gov/mips/explore-mips-value-pathways/2024/M0005.
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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.\90\ We proposed in the CY 2025 PFS
proposed rule that 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
are indicative of high-quality 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.
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\90\ https://www.cms.gov/medicare/quality/cms-national-quality-strategy/aligning-quality-measures-across-cms-universal-foundation.
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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. The TPCC measure is a population-based cost 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.\91\
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\91\ https://qpp.cms.gov/docs/cost_specifications/2023-12-13-mif-tpcc.pdf.
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We proposed in the CY 2025 PFS proposed rule that 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 proposed 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.\92\
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\92\ https://qpp.cms.gov/mips/mvps/learn-about-mvp-reporting-option?option=Group.
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We discussed in the CY 2025 PFS proposed rule that MIPS eligible
clinicians who report the MVP are also required to report the Promoting
Interoperability performance category objectives, measures, and
required attestations throughout the performance period in which they
bill for APCM services,\93\ as required under Sec. 414.1375(b) (Sec.
414.1365(c)(4)(i)) (see section IV. of the CY 2025 PFS proposed
[[Page 97891]]
rule for details on reporting the objectives, measures, and required
attestations for the MIPS Promoting Interoperability performance
category for the CY 2025 performance period/2027 MIPS payment year and
see section II.G.c.(10) in this final rule for a summary). The MIPS
Promoting Interoperability performance category includes measures such
as supporting electronic referral loops by sending health information,
supporting electronic referral loops by 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 Sec. 414.1375(b)(3), the MIPS
Promoting Interoperability performance category 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.\94\
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\93\ The MIPS Promoting Interoperability 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)).
\94\ Note that, under the Quality Payment Program, CMS may
reweight the MIPS Promoting Interoperability 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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We noted as part of the CY 2025 PFS that, for CCM services (CPT
codes 99437, 99439, 99487, and 99489--99491) and PCM services (CPT
codes 99424--99427), we established a practice-level service element
requiring the meaningful use of 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 proposed in the CY 2025 PFS proposed rule for
practitioners who are MIPS eligible clinicians a practice level
requirement to register for and report the MVP, including but not
limited to reporting the Promoting Interoperability performance
category objectives, measures, and required attestations which focus on
meaningful use of CEHRT, for the performance year in which they furnish
and bill for APCM services. This would ensure that patients/caregivers
and physicians or other qualified practitioners or clinical staff have
real-time access to patient's medical information. Meaningful use of
CEHRT 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, 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
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 repeated exams.\95\ For example, practices can 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.\96\ Standardized communication methods, enabled by
the meaningful use of 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 enable 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.\97\ 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,
the meaningful 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 MIPS
Promoting Interoperability performance category requirements
demonstrating 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),\98\ and the MCP model's
requirement that participating practices use EHR technology that has
been certified under the ONC Health IT Certification Program \99\).
Furthermore, the Shared Savings Program generally requires ACO
participants, providers/suppliers, and professionals (including MIPS
eligible clinicians, QPs and Partial QPs participating in the ACO) to
demonstrate meaningful use of CEHRT through the reporting of the MIPS
Promoting Interoperability performance category measures and
requirements annually beginning in Performance Year 2025 (Sec.
425.507).
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\95\ 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.
\96\ Harvey, Jillian B., et al. ``Understanding how health
systems facilitate primary care redesign.'' Health Services Research
55 (2020): 1144-1154.
\97\ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3475839/#CR25.
\98\ https://www.cms.gov/priorities/innovation/innovation-models/primary-care-first-model-options.
\99\ https://www.cms.gov/priorities/innovation/innovation-models/making-care-primary.
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We noted as part of the CY 2025 PFS that there are many
practitioners who would not be MIPS eligible clinicians for a year
because they would have earned Qualifying APM Participant (QP) status
based on meeting threshold levels of participation in an Advanced APM.
Based on the characteristics of Advanced APMs described in Sec.
414.1415, including the requirement that payment is based on MIPS or
MIPS-comparable quality measures, practitioners who have earned 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,
[[Page 97892]]
such as practitioners who are newly enrolled in Medicare or bill a low
volume of Medicare services. We proposed in the CY 2025 PFS proposed
rule that these practitioners technically could bill for APCM services
if they meet the service and practice level requirements to do so. We
note that 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.
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 also proposed as described in section II.G.c. of this final
rule, that the performance measurement element of the APCM services
will 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 will be required to report the APP Plus quality
measure set in section III.G. of this final 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 proposed in the CY 2025 PFS proposed rule to include the
performance measurement requirement as an element of APCM services
furnished by practitioners, see section II.G.2.c. of this final rule.
MIPS eligible clinicians who intend to report on the Value in Primary
Care MVP for the CY 2025 performance period/2027 MIPS payment year must
register to report the Value in Primary Care MVP as described under
Sec. 414.1365(b). Generally, 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 satisfies 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 satisfies 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 in section II.G.2.c(9) of this final rule, we sought
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 sought 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 sought feedback on whether there are areas of duplication within
the APCM service elements and practice capabilities that we should
consider addressing.
We also sought comment on how to appropriately align 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 received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: We received several comments supporting the practice-level
performance measurement requirement, and a few commenters appreciated
that we were using an existing reporting pathway via the Value in
Primary Care MVP for practices to meet the performance measurement
requirement. A few commenters requested that we phase the performance
measurement requirement over time, while others requested we remove it
entirely, indicating it may be a barrier for some entities to utilize
the APCM codes. Several commenters suggested that we require the
reporting of specific quality or patient experience measures, while
several other commenters offered that we should allow the reporting of
other, specialty-specific MVPs to fulfill the performance measurement
requirement, as specialists may bill for APCM if they are directing the
beneficiary's primary care and continue to be the focal point of a
beneficiary's primary care.
Response: We chose to propose the Value in Primary Care MVP as the
mechanism for meeting the performance measurement requirement both
because of the flexibility it offers practitioners in reporting on
quality metrics that align with their patient populations and because
the measures included in the Value in Primary Care MVP focus on the
clinical theme of promoting quality care for patients in order to
reduce the risk of diseases, disabilities, and death. While we
understand that a specialist may intend to take responsibility for all
of a patient's primary care and serve as the continuing focal point for
all needed health care services, and meet other requirement to bill for
APCM services, as discussed earlier, the specific measures within the
Value in Primary Care MVP are best suited to measure the performance in
the context of advanced primary care services; and that performance
measurement is a key characteristic of advanced primary care that is
critical for the improvement of primary care delivery over time. We
appreciate the commenters' feedback and may take these points into
consideration for possible future rulemaking. At this time, we continue
to believe the Value in Primary Care MVP is the best fit for purposes
of performance measurement for MIPS eligible clinicians furnishing APCM
services. Therefore, it would not be appropriate to specify that the
performance measurement requirement could be met by reporting a
different MVP.
Comment: A few commenters indicated that it may be difficult or
expensive for some practitioners to meet the MIPS Promoting
Interoperability performance category requirements, so the electronic
data sharing and integration requirements of the Value in Primary Care
MVP should be removed or delayed.
Response: Health IT and interoperability, through electronic
exchange of health information and having up-to-date information from
[[Page 97893]]
multiple clinicians, can have a positive impact on patient care and
enhance efficiency and productivity. The same MIPS Promoting
Interoperability performance category requirements we are adopting
generally apply to those MIPS eligible clinicians who report MVPs as
those reporting traditional MIPS. Therefore, MIPS eligible clinicians
who want to furnish and bill for APCM services may demonstrate their
meaningful use of CEHRT through the MIPS Promoting Interoperability
performance category requirements.
We acknowledge that there are several cases in which a MIPS
eligible clinician may be excepted from reporting for one or more MIPS
performance categories and, thus, not all practitioners billing for
APCM services will have to meaningfully use CEHRT and meet requirements
for reporting the MIPS Promoting Interoperability performance category.
A MIPS eligible clinician may request, that they be excepted from
reporting MIPS Promoting Interoperability under the MIPS reweighting
policies at Sec. 414.1380(c)(2)(i). If we approve the reweighting/
exception, then the MIPS eligible clinician does not need to adopt or
meaningfully use CEHRT or report MIPS Promoting Interoperability
objectives, measures, or attestations. Similarly, these same exceptions
to reporting MIPS Promoting Interoperability have also been made
available to ACO participants under 42 CFR 425.507(b).\100\
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\100\ Link to recent guidance is at https://www.cms.gov/files/document/frequently-asked-questions-shared-savings-program-requirement-report-objectives-and-measures-mips.pdf.
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We also reiterate that there are practitioners who would not be
MIPS eligible clinicians for various reasons--for example, they would
have earned QP status based on meeting threshold levels of
participation in an Advanced APM, they are newly enrolled in Medicare,
or they bill a low volume of Medicare services. These practitioners
could bill for APCM services if they meet the service elements and
practice-level requirements to do so, but we believe it is appropriate
for several reasons not to require these practitioners to meet the
performance measurement requirement for APCM services through reporting
the Value in Primary Care MVP to MIPS. Eligible clinicians excluded
from MIPS based on their QP status earned through sufficient
participation in an Advanced APM are necessarily engaging in
performance measurement through the Advanced APMs in which they
participate in a way that is consistent with advanced primary care. As
noted previously, Advanced APMs must meet several criteria including
payment based on MIPS or MIPS-comparable quality measures, CEHRT use,
and assumption of more than a nominal amount of financial risk. Newly
enrolled practitioners are excluded from MIPS for only one year, after
which the practitioner would need to meet the performance measurement
requirement to bill for APCM services. While some newly enrolled
practitioners would not report at all during this initial year, we note
that many others would furnish APCM services as part of a group
practice with other practitioners who deliver advanced primary care.
Such a practice would be likely to meet the practice-level requirements
with respect to other practitioners in the group who may bill for APCM
services. As for eligible clinicians excluded from MIPS based on low
Medicare volume, these practitioners are unlikely to furnish advanced
primary care or bill the Medicare program for APCM services since the
delivery of advanced primary care generally involves routine and
ongoing care delivery, and a significant investment of time and
resources to establish practice-level infrastructure. Such a practice
would be more likely to make the investments necessary to provide
advanced primary care if the infrastructure can be utilized across a
larger patient panel. We may consider whether to address performance
measurement requirements for these practitioners in future rulemaking.
Comment: A few commenters suggested that we should not require
practitioners participating in an APM to report the Value in Primary
Care MVP. Several commenters requested that participants in other CMS
Innovation Center models be able to meet the performance measurement
requirement by meeting requirements of their model participation, and
not have to report the Value in Primary Care MVP.
Response: While we understand that practitioners participating in
many APMs, including other Advanced APMs, are subject to performance
measurement requirements under the APM, the measures within the Value
in Primary Care MVP are best suited to performance evaluation in the
delivery of advanced primary care services. We specifically identified
the Shared Savings Program, the ACO REACH model, the Primary Care First
model, and the Making Care Primary model, as APMs in which the
performance measurement requirements significantly overlap with or are
aligned with the Value in Primary Care MVP. We proposed that for
practitioners participating in these APMs, the practice-level
performance measurement requirement for APCM services can be met by
meeting requirements under these APMs. At this time, the performance
measurement requirements of other APMs are not sufficiently aligned
with the Value in Primary Care MVP.
Comment: Several commenters requested we clarify how APCM services
and the performance measurement requirements could be implemented by
Medicare Advantage or other payers, and expressed concern that other
payers would not use the APCM coding and payment.
Response: We designed the APCM code set, including the practice-
level performance measurement requirement, for purposes of payment
under FFS Medicare. We recognize that the practitioners and practices
that provide care using an advanced primary care delivery model would
be likely to care for patients with a broad range of health care
coverage. We also recognize that other health care payers sometimes
pick up coding adopted for the FFS Medicare program to use for their
own purposes. We note that the CPT Editorial Panel often considers
establishing CPT codes that either replace or considerably overlap with
HCPCS G-codes that CMS establishes. Other payers may consider working
with the AMA in this regard. Additionally, we note that the code
descriptors for the APCM services do not reflect all of the detailed,
Medicare-specific characteristics of the billing and payment policies
we are finalizing for APCM services. As such, we anticipate that other
payers could adopt and use the APCM HCPCS codes by adapting their own
billing and payment policies as needed. We note that the quality
measures utilized in the Value in Primary Care MVP can also be utilized
by other payers. To the extent that other payers, including Medicare
Advantage organizations, Medicaid State plans, or commercial payers,
decide to use the APCM codes, we encourage them to adopt requirements
that align with ours in the interest of efficiency and burden reduction
for practitioners. We also note that multi-payer alignment around
performance measurement for APCM services would help focus attention on
the Universal Foundation measures that are included in the Primary Care
MVP.
After consideration of public comments, we are finalizing the
``Performance Measurement'' requirement as proposed. To satisfy this
practice-level requirement, practitioners who are MIPS eligible
clinicians must register for and report the Value in Primary Care MVP
for the performance
[[Page 97894]]
year in which they bill for APCM services. A practitioner who is part
of a TIN that is participating in a Shared Savings Program ACO or a
REACH ACO, or in a Primary Care First or Making Care Primary practice
would meet these requirements by virtue of meeting requirements under
the Shared Savings Program or CMS Innovation Center ACO REACH, Making
Primary Care Primary, or Primary Care First models.
We acknowledge that there are many practitioners who are not MIPS
eligible clinicians for a year because they earned QP status through
sufficient participation in an Advanced APM. These practitioners will
meet the performance measurement requirement for APCM services through
their involvement in an Advanced APM. 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.
We also acknowledge that there are several circumstances under
which a MIPS eligible clinician may be excepted from reporting in one
or more MIPS performance categories. Thus, some MIPS eligible
clinicians could meet the performance measurement requirement for APCM
services without demonstrating meaningful use of CEHRT by reporting the
MIPS Promoting Interoperability performance category. A MIPS eligible
clinician may request (and CMS may approve) that they be excepted from
reporting MIPS Promoting Interoperability under the MIPS reweighting
policies at 42 CFR 414.1380(c)(2)(i). If we approve the reweighting/
exception, then the MIPS eligible clinician does not need to adopt or
meaningfully use CEHRT or report MIPS Promoting Interoperability
objectives, measures, or attestations. Similarly, these same
exclusions/exceptions to reporting MIPS Promoting Interoperability have
also been made available to ACO participants under 42 CFR 425.507(b).
We note that these exceptions are generally temporary due to
extraordinary circumstances, and in general, over the long term,
practitioners and practices are expected to report in all MIPS
performance categories.
We are clarifying that the practice-level performance measurement
element of APCM services does not apply for practitioners who are not
MIPS eligible clinicians, for example, because they are newly enrolled
or bill a low volume of services under the Medicare. As explained
previously, we recognize that these practitioners technically could
bill for APCM services if they meet the other service elements and
practice-level requirements to do so. We may consider whether to
address performance measurement requirements for them in future
rulemaking.
We summarize the final service elements and practice-level
requirements for the APCM services in Table 25.
d. Duplicative Services and Concurrent Billing Restrictions
We proposed in the CY 2025 PFS proposed rule to identify the
services that will overlap substantially with APCM services based on
the elements of the scope of service for APCM which we have built into
the service descriptors for G0556, G0557, and G0558 (see sections
II.G.2.b. and II.G.2.c. of the CY 2025 PFS proposed rule). As such, we
proposed 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 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 26) 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.
[[Page 97895]]
[GRAPHIC] [TIFF OMITTED] TR09DE24.058
As we have described in the sections earlier, 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 23 are substantially the same as the elements we
proposed for APCM services.
Also described earlier, providing CTBS is an essential element of
the delivery of care under an advanced primary care model of care.
Recognizing this, we designed the APCM service elements to
substantially overlap with the elements of the CTBS (for example,
interprofessional consultation and e-Visits) shown in Table 26. 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 will allow patients to access their usual source of care more
conveniently.\101\ Furthermore,
[[Page 97896]]
interprofessional consultation can help promote integration of
behavioral health and primary care.\102\
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\101\ 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.
\102\ 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 final rule.
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We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: Commenters were mixed on many of our proposals. Many
commenters did not agree with our proposed concurrent billing
restrictions for the codes shown in Table 26 by a practitioner in the
same practice as a practitioner who is furnishing APCM services for the
patient. Some commenters pointed out that specialists within large
hospital systems or multispecialty clinics may fall under the ``same
practice'' restriction; these commenters also suggested that
beneficiaries receiving APCM services from their primary care
practitioner should still be eligible to receive PCM and many of the
interprofessional consultation services furnished by specialists if
needed to augment a beneficiary's care. One commenter stated that a
patient may be receiving APCM services from their primary care
practitioner but receiving PCM from their cardiologist who works for
the same practice and was concerned the proposed concurrent billing
restriction would impede the beneficiary's care. Other commenters
expressed similar concerns regarding our inclusion of all of the
interprofessional consultation codes, again stating that these codes
are most often used by consulting specialists, and expressing concern
that limiting these concurrent billing for these codes may have a
cooling effect on specialists willing to provide consultations.
Most commenters agreed that CCM and TCM were duplicative with APCM
if performed by the same practitioner. A few commenters stated that TCM
may be duplicative, but that it depends on the reason for the
hospitalization. For example, if a patient is hospitalized for cancer
treatment or a surgery, it may be an oncologist or surgeon performing
TCM, rather than the primary care practitioner performing APCM.
Response: Our intention in proposing the concurrent billing
restrictions for APCM services and the identified codes was to prevent
duplicative payment for advanced primary care services by multiple
practitioners in the same practice. However, we agree with commenters
who recommended that specialists should still be able to furnish the
services listed in Table 26 concurrently to patients receiving APCM
from another practitioner, when medically reasonable and necessary. We
recognize that there are clinical circumstances where a specialist
would be the practitioner who furnishes and primarily oversees the care
of a beneficiary during one or more months. For example, an oncologist
could primarily manage care, including providing TCM services, for a
patient who is recently discharged after an admission related to
chemotherapy side effects while another practitioner in the same
practice could appropriately continue to furnish APCM services for the
same patient during the same month. We agree with commenters that the
services listed in Table 26 are not necessarily duplicative when billed
by another practitioner in the same practice as the practitioner who is
billing for APCM services, and accordingly, are finalizing a modified
policy. After consideration of public comments, we are not finalizing
the concurrent billing restrictions, except with respect to the one
practitioner who is furnishing APCM services. The services listed in
Table 26 may not be billed for a patient in the same month with APCM
services by the same practitioner but may be billed when medically
necessary for a patient in the same month by a practitioner other than
the practitioner furnishing APCM services (HCPCS G0556, G0557, and
G0558). We remain committed to engaging with interested parties on
these policies, and we may examine these requirements further in future
rulemaking.
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 APCM services. 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 will be likely to furnish, when
appropriate, they are not part of the core, routinely and universally
essential elements of the advanced primary care model. Several of these
other services (such as BHI, CHI, SDOH Risk Assessment, and PIN) could
be supplemental to APCM for patients that have specific identified
health care needs.
We sought more information from interested parties through our
Advanced Primary Care RFI about whether to consider incorporating
additional service elements into the ACPM 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 also
sought information regarding how evolving changes in practice may
warrant reconsideration of payment and coding policies.
We proposed that the care management and CTBS codes that are
identified in Table 23 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. As explained
previously, we are modifying this proposal to apply the concurrent
billing restrictions for these codes only to the practitioner who bills
for APCM services. We stated that we believed this would prevent
duplicative payments for substantially similar services and would also
be 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 did not propose 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. For CY 2025, those codes
will
[[Page 97897]]
still be available for practitioners who do not furnish care using the
advanced primary care model or who may find that the existing care
management and CTBS codes best describe the services they furnish.
We also sought comment on potential overlap between APCM services
and other services, including but not limited to care management and
care coordination and other CTBS. If interested parties identify
overlaps between APCM and other services, we sought comment on whether
the degree of overlap will warrant a policy to restrict the services
from being billed concurrently with APCM. We also sought comment on
whether any overlap will 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 earlier, 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 payment for APCM,
elements of the proposed APCM service, and these duplicative services,
and seek to implement appropriate payment policies.
We received public comments on these considerations. The following
is a summary of the comments we received and our responses.
Comment: Nearly all commenters were supportive of our proposal to
allow concurrent billing of BHI, CHI, PIN, PIN-PS, and the SDOH Risk
Assessment with APCM services. Commenters agreed that these services
are unique and serve specific needs not otherwise met by the proposed
APCM coding. Many commenters discussed the importance of behavioral
health (including mental health and substance use disorders) on overall
health and urged us to consider including behavioral health in future
rulemaking as it relates to advanced primary care citing the growing
need for fully integrated physical and behavioral health. These
commenters also urged us to examine utilization of APCM services in
conjunction with BHI, PIN, and PIN-PS, to inform future work. One
commenter requested clarification on whether the Psychiatric
Collaborative Care Model (CoCM) codes could be billed in conjunction
with APCM.
Response: We agree with commenters that these services are
complementary to APCM services, and do not represent duplication of
services as long as time and effort involved in furnishing these
services are not counted more than once, requirements to bill the other
services are met, and the services are medically reasonable and
necessary. We also agree with commenters that behavioral health is
important in the context of overall health, and we will take comments
recommending strategies for further integration into consideration for
future rulemaking. We are also clarifying that the BHI codes paid under
the PFS (CPT codes 99492, 99493, 99494, and 99484 and HCPCS code
G0323), including CoCM, can be billed concurrently with the APCM codes
when all applicable requirements for billing both codes are met. As we
stated in the CY 2025 proposed rule, 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. We continue to be interested in the use
of BHI services as they relate to advanced primary care and welcome
input from interested parties, including how evolving changes in
practice may warrant reconsideration of payment and coding policies.
Comment: Some commenters expressed that RTM and RPM should not be
included within the APCM codes, but rather billed separately as
complementary, non-duplicative services. A few commenters stated that
RTM and RPM services are not core services that are routinely and
universally essential elements of advanced primary care models and
should therefore not be included in the definition of APCM. One
commenter asserted that these services are not likely to be furnished
by the types of practitioners who would also furnish advanced primary
care services.
Response: We agree with commenters that RTM and RPM services are
complementary to APCM services, and do not represent duplication of
services, as long as time and effort involved in furnishing these
services are not counted more than once, requirements to bill the other
services are met, and the services are medically reasonable and
necessary. While we agree with the commenter that these services may
not be part of the core, routinely and universally essential elements
of the advanced primary care model, we disagree that these services are
unlikely to be furnished by a practitioner also furnishing advanced
primary care services. We are finalizing our policy that RTM and RPM
services can be billed concurrently with APCM services when all
applicable requirements for billing both services are met. We continue
to be interested in the use of RPM and RTM services as they relate to
advanced primary care and welcome input from interested parties.
After consideration of public comments, we are finalizing our
proposal to allow concurrent billing for BHI, CHI, PIN, PIN-PS, the
SDOH Risk Assessment, RPM, and RTM services in the same month as APCM
services. We remain committed to engaging with interested parties on
these policies, including whether there is overlap between APCM
services and other services and whether to consider incorporating
additional service elements into the APCM service elements and
valuation for APCM codes, and we may examine these policies further in
future rulemaking.
e. Valuation of APCM Services--HCPCS Codes G0556, G0557, and G0558
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 proposed to create three HCPCS codes to use for reporting the APCM
service (HCPCS codes G0556, G0557, and G0558) (sections II.G.2.b. and
II.G.2.c. of the CY 2025 PFS proposed rule). Although these codes are
unique in that they would be created to differentially pay for advanced
primary care management, the 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 the CY 2025 PFS proposed
rule). As we ordinarily do, we proposed 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.
We detailed our methods to identify a typical case and set of
resources involved in furnishing APCM, and the
[[Page 97898]]
valuation of these codes. To value APCM, we compared the service
elements described by the APCM codes to the values we have established
for the specific care management and CTBS codes on which we modeled the
service elements of the APCM codes and which we built into the service
descriptors for HCPCS codes G0556, G0557, and G0558 (see Table 23 and
sections II.G.2.b. through II.G.2.d. of the CY 2025 PFS proposed rule).
As stated above, the 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
stated 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
different services have been used historically and relate that
information to the way we think 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 better recognize likely utilization of the new codes
and the work required to furnish APCM services, this is challenging
without more information. We welcomed 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 proposed 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 noted 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
the proposed rule, to help us identify the best approach to reflecting
the proposed CTBS elements incorporated into the APCM monthly bundle,
and we remain 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.
We received many public comments on our proposed valuation.
Following is a summary of comments received and our responses.
Comment: We received many comments in response to our request for
other sources of data that would help us assess the valuation for APCM.
Commenters expressed concerns with using the RUC as the basis for this
information, citing underrepresentation on the RUC for primary care and
historical underpayment of primary care services. Many commenters
stated the need for empirical data for physician work, time and
practice expense requirements for APCM services, with a few commenters
discussing the challenge of adequately accounting for the resource
costs associated with care management services and the use of team-
based care. Many commenters discussed the need for time studies to
validate valuation, and others stated there is a need for more research
into primary care services that are not currently recognized for
payment. One commenter suggested that physician time studies be
conducted utilizing time stamp data from EHRs to accurately log how
long practitioners spend on documentation. A few of the commenters
asked us to conduct these studies, with another commenter asking us and
Congress to undertake this work.
Response: We value the work and effort the RUC undertakes to
provide us with data and recommendations for valuing services under the
PFS, and we also remind commenters that we do not exclusively rely on
RUC recommendations and can receive data and recommendations from other
outside sources as well. We also agree with commenters that empirical
information about how primary care services are provided would be
invaluable to assist us in making refinements to payment for APCM
services to improve accuracy. We are especially interested in practice-
level data that are empirical, routinely updated, able to be audited,
and comprehensive. We are also open to receiving partial information,
and we note that interested parties can submit information to us
through the potentially misvalued codes process that is described in
Section II.C. of this final rule. We note that submissions for
consideration in our next annual rule cycle should be received by our
February 10th deadline. For example, this could include information
related to the practice expense involved in furnishing these services,
such as the types of clinical staff, disposable supplies, and
equipment, as well as the physician or practitioner work involved in
furnishing these services. We note that the CY 2025 PFS public use
files, which are available on the CMS website under downloads for the
CY 2025 PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-ServicePayment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html,
include a sample PE spreadsheet and a sample work spreadsheet.
Additionally, we are open to alternative recommendations for how to
price these and other services, and we will consider all options
presented to us, with a preference for information with empirical
evidence behind it. We welcome interested parties to engage with us on
how external data sources could be developed and leveraged.
[[Page 97899]]
Comment: Commenters generally suggested that the proposed valuation
for APCM services underestimated the time and resources involved in
providing the activities required under APCM such as 24/7 access to
care, patient population-level management, and performance management.
Commenters also stated concern with the increased costs of staff and
infrastructure potentially associated with performing APCM. Commenters
stated that with the low valuation proposed, practitioners would
continue to choose existing care management codes or other PFS
services, resulting in low uptake for APCM. Still others were concerned
that inadequate payment could discourage provider participation,
particularly in underserved areas where the need for comprehensive,
team-based care is greatest. These commenters stated that smaller
practices in rural areas may lack the potential to benefit from
economies of scale to support the infrastructure necessary to meet APCM
requirements.
Response: We generally agree with commenters that these services
may be undervalued, given the time and resources that are necessary for
the provision of advanced primary care, but we also recognize there
could be a wide range of potential resource costs, especially during
the initial use of the codes. Consequently, we may revisit valuation of
these APCM services in future rulemaking. As previously described, if
interested parties submit additional data and information upon which to
base revised valuation assumptions, that information could form a basis
upon which we could refine values for the APCM codes through future
rulemaking. We appreciate that the scope and service elements for APCM
are more expansive than existing CCM and PCM coding; however, we
recognize that some beneficiaries will need more services and some
less, and thus, as we ordinarily do, we proposed to value these
services based upon the typical service. We agree with commenters that
ensuring that these services are available to rural and underserved
populations is an important priority. We may consider making
refinements to the valuation, billing rules, and documentation
requirements through future rulemaking, as necessary.
Comment: Commenters discussed our valuation methodology, urging us
to avoid continuing what they view as underinvestment in primary care
by valuing APCM services with reference to CCM services. Commenters
also stated that CCM is not a correct reference for valuation of APCM
services as CCM does not include all the service elements required for
APCM. Other commenters recommended we use CMS Innovation Center model
per beneficiary per month (PBPM) payments and conduct greater research
to determine more appropriate payment rates. Commenters also discussed
valuation in the context of concurrent billing restrictions, with some
commenters citing the inclusion of CTBS and interprofessional
consultation services for which payment rates are in some cases higher
than the monthly rate for APCM.
Response: We continue to believe that the most accurate mechanism
for determining the appropriate work RVU for this service is to refer
to values established for existing CPT codes. We note further that
using CCM codes as a reference to value the APCM codes would have the
benefit of assuring appropriate relativity with similar services.
Comment: We also received comments that were in favor of our
proposed valuations. A few commenters recommended that we finalize as
proposed and monitor utilization as the codes are implemented. Another
commenter recommended that we finalize as proposed, even if the code
descriptors and associated payment rates need to be refined in the
future as interested parties gain experience with the new codes and
provide feedback.
Response: We agree with commenters that the valuation of these
services is likely to be an iterative process, and we may revisit our
valuation of these codes in future rulemaking.
(1) APCM Level 1 (HCPCS Code G0556)
For APCM Level 1, we assume the typical case will involve fewer
resources than the current care management services based upon the
G0556 code descriptor and a broad eligible population that will require
limited monthly APCM services; however, it will 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. of the CY 2025 PFS proposed rule, 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 will 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 inputs on CPT code 99490 multiplied by
\1/6\ (or 2 units over 12 months). Specifically, we propose a work RVU
for G0556 of 0.17, which is the work RVU for CPT code 99490 multiplied
by \1/6\. The resulting 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).\103\ Table 27 displays payment amount
estimates using the 2024 PFS Conversion Factor.
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\103\ https://www.cms.gov/medicare/payment/fee-schedules/physician/federal-regulation-notices?DLSort=2&DLEntries=10&DLPage=1&DLSortDir=descending.
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We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: Many commenters expressed concerns that the proposed
valuation of G0556 would be inadequate to support the work and
necessary infrastructure of this care delivery model. Several
commenters pointed out that the proposed work RVU of 0.17 for G0556 is
significantly lower than or similar to the work RVUs for the following
duplicative component services that cannot be billed during the same
period with APCM: CPT code 99426 (PCM, first 30 minutes) which has a
work RVU of 1.00 and CPT code 99427 (PCM, each additional 30 minutes)
which has a work RVU of 0.71, and these codes would be appropriate for
managing similar patients as G0556. Another commenter stated that HCPCS
code G2012 (Virtual check-in), which is a type of CTBS that cannot be
billed concurrently with APCM is reimbursed at a national rate of
$13.81, which is less than the proposed rate for one month of care as
described by HCPCS code G0556. Several commenters also asserted that
HCPCS code G0556 would result in more billing and administrative costs
than would be covered by the proposed $10 payment, leading to decreased
uptake. A few commenters also discussed a ``payment gap'' between G0556
and G0557, stating that the difference in both work and practice
expense (PE) between the two codes is not as disparate as a $40 change
in payment suggests.
Response: We are sensitive to the administrative burden of new
coding and payment and sought to reduce administrative burden through
the use of bundling elements of existing codes
[[Page 97900]]
for APCM. We appreciate the commenters' thoughts on the investments
required to perform APCM in general, and we understand the commenters'
perspectives about the ``payment gap'' between two codes that require
the same level of practice capabilities. We look forward to continuing
to engage with interested parties as these codes are billed, and we
remain open to feedback on how to best value these codes in future
rulemaking.
Comment: Commenters had several proposed solutions to increase the
valuation of HCPCS code G0556. Several commenters suggested that we
increase the work RVU for G0556 to 0.77, equal to that of G0557, to
reflect the equivalent physician time required when managing any number
of chronic conditions and to better align with existing work RVUs for
CCM and PCM. Another commenter suggested we align the valuation of
HCPCS code G0556 to the population-based payments made under the
Primary Care First (PCF) model. Another commenter agreed that we should
use PCM and the PCF model's payments as benchmarks but instead
suggested that we increase the work RVU for G0556 to 0.25, equal to
three billing units of CPT code 99490 over an annual period, or 60
minutes of physician work in CCM equivalents. This commenter also
suggested that the proposed work RVU of 0.17 underestimates the
physician work required to establish and maintain these plans of care,
even if many service elements are not performed every month. This
commenter estimated that the creation of a care plan as described in
the service elements would take between 20 and 40 minutes, which they
viewed as incompatible with our proposal of estimating 2 units of 99490
or 40 minutes of work time spread over 12 months.
Another commenter argued that the assumption that Level 1 APCM
services would be similar in work to that of two billing units of CPT
code 99490 over the course of a year is flawed, as it assumes a ``sick
care'' model of care delivery rather than one focused on prevention.
Several commenters also pointed out that the infrastructure required to
furnish all of the practice elements must be in place even if that
beneficiary does not need those services that month and that this was
especially true for beneficiaries receiving G0556.
Response: We appreciate the alternate methods suggested by
commenters, and we are persuaded that the proposed rate for G0556 would
not fully capture the relative resource costs involved in providing
continuous, ongoing care management through an advanced primary care
model of care delivery. We agree with commenters that the methodology
suggested of increasing HCPCS code G0556 to the equivalent of three
units of 99490 divided over 12 months would better account for the work
and PE involved in furnishing APCM services.
After consideration of public comments, we are increasing the
valuation of HCPCS code G0556 to reflect the equivalent of three units
of 99490 or 60 minutes of work time in CCM equivalents divided over 12
months, or approximately $15 per month. This represents a work RVU of
0.25. We recognize this is a relatively modest increase in valuation
for G0556, and we may revisit the valuation of this and other APCM
codes in future rulemaking.
(2) APCM Level 2 (HCPCS Code G0557)
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 will involve significantly more resources and require more,
and more frequent, APCM service elements. We concluded that the APCM
Level 2 services will 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 proposed to
account for 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, this
evidences that CCM services (especially complex CCM services) continue
to be underutilized,'' as discussed in the CY 2020 PFS final rule (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.\104\ Therefore, we based the proposed inputs
on CPT code 99490 multiplied by \5/12\ (or, five units 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 G0557 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 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).\105\ Table 27 displays
payment amount estimates using the 2024 PFS Conversion Factor.
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\104\ 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.
\105\ https://www.cms.gov/medicare/payment/fee-schedules/physician/federal-regulation-notices?DLSort=2&DLEntries=10&DLPage=1&DLSortDir=descending.
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We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: Several commenters appreciated our attempt to account for
the underutilization of CCM services in the proposed valuation, but one
commenter asserted that those adjustments still only account for the
resources associated with CCM and not the increased work or practice
expenses incurred with maintaining practice-level advanced primary care
capabilities or providing APCM services to more beneficiaries.
[[Page 97901]]
Like HCPCS code G0556, several commenters pointed out that the
proposed work RVU of 0.77 for HCPCS code G0557 is lower than for the
following duplicative component services that cannot be billed during
the same period with APCM: CPT code 99426 (PCM, first 30 minutes) which
has a work RVU of 1.00; CPT code 99427 (PCM, each additional 30
minutes) which has a work RVU of 0.71; CPT code 99490 (CCM, clinical
staff first 20 minutes) which has a work RVU of 1.00; and CPT code
99439 (CCM, clinical staff each additional 20 minutes) which has a work
RVU of 0.70. Commenters assert that the proposed HCPCS code G0557
closely resembles CPT codes 99490 and 99439 for CCM, as all three codes
would apply to care management for patients with two or more chronic
conditions. One commenter recommended that payment of G0557 be equal to
or greater than CPT code 99490. Another commenter asserted that the
proposed valuation for G0557 does not account for the extensive work in
creating a comprehensive care plan, citing that this was an initial
barrier when the care management codes were first introduced and
improved somewhat once the guidelines became less prescriptive.
Another commenter was concerned about an inconsistency between the
assumptions underlying valuation and those underlying our utilization
estimates for the services. The commenter explained that for purposes
of estimating utilization, we assumed that beneficiaries who receive
APCM services will do so for 12 months each year; however, the
valuation methodology assumed beneficiaries receive only a fraction of
that--for example, the proposed inputs for G0557 were based on CPT code
99490 multiplied by \5/12\, CPT add-on code 99439 multiplied by \1/6\,
CPT add-on code 99489 multiplied by \1/12\, and CPT code 99487
multiplied by \1/12\. From their perspective, it seems unreasonable to
expect practices to maintain APCM capabilities and provide APCM
services for 12 months while setting the value of those capabilities
and services at a fraction of that time.
Response: We thank commenters for their feedback. We continue to
reiterate that because the APCM codes are a bundle of existing care
management and other services, not all of which would be furnished in
each month in which the APCM services are billed, and the estimates of
utilization of services are divided across the span of 12 months, we
believe that our proposed valuation reference is an appropriate
approach to estimate the work, time, and intensity of HCPCS code G0557.
We also reiterate our assumption that beneficiaries receiving APCM
services may not require any services one month and may have increased
utilization the next month. We are attempting to reflect the varying
care needs of the beneficiary, with an understanding that needs often
ebb and flow over a period of months for which APCM services are
furnished. As discussed previously, we appreciate that APCM services
require different practice capabilities as compared to other care
management services and may revisit valuation of all APCM services in
future rulemaking.
After consideration of public comments, we are finalizing the
valuation of G0557 as proposed. We are finalizing the proposed work RVU
of 0.77.
(3) APCM Level 3 (HCPCS Code G0558)
For APCM Level 3 (HCPCS code G0558), which describes APCM services
to patients with QMB status and two or more chronic conditions, we
proposed 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.\106\ 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 can capture
the increased resources involved in furnishing APCM services to
patients with QMB status and multiple chronic conditions. Therefore, we
based the inputs for the APCM Level 3 code on the APCM Level 2 inputs
multiplied by 218 percent. Specifically, we proposed a work RVU for
G0558 of 1.67, which is the work RVU for G0557 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).\107\ Table 27 displays payment amount
estimates using the 2024 PFS Conversion Factor.
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\106\ https://www.macpac.gov/wp-content/uploads/2024/01/Jan24_MedPAC_MACPAC_DualsDataBook-508.pdf.
\107\ https://www.cms.gov/medicare/payment/fee-schedules/physician/federal-regulation-notices?DLSort=2&DLEntries=10&DLPage=1&DLSortDir=descending.
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We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: Most of the comments we received about the valuation of
HCPCS code G0558 were in conjunction with comments about expanding or
changing our proposed population for HCPCS code G0558 and did not
provide specific valuation recommendations. A few commenters thanked us
for this proposal and hoped that including QMBs specifically would
incentivize practitioners to care for this population. Other commenters
stated that CMS Innovation Center models like Primary Care First (PCF)
and Comprehensive Primary Care Plus (CPC+) make high complexity payment
rates of $200-$250, and these commenters recommended we align G0558
with these values.
Response: We appreciate the reference to various CMS Innovation
Center models. We note that each of the models targeted specific
patient populations with different approaches and payment
methodologies, serving a different but complementary purpose than the
coding and payment policies for APCM services. We share the hope of
commenters that HCPCS code G0558 will encourage practitioners to
furnish APCM services to this population. As discussed previously, we
may revisit APCM service valuations in future rulemaking.
After consideration of public comments, we are finalizing the
valuation of G0558 as proposed. We are finalizing the proposed work RVU
of 1.67.
Table 27 includes the finalized codes, short descriptors, reference
codes, work RVUs, and approximate payment rate. For illustration
purposes, we multiplied the 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 relative
value units (RVUs) into approximate national payment rates.
[[Page 97902]]
[GRAPHIC] [TIFF OMITTED] TR09DE24.059
We sought feedback on whether these values appropriately reflect
the resource costs involved in furnishing these services, or whether
adjustments to the 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 future years,
and we expect that having APCM utilization data, once the codes are
established, will 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 service elements (see section
II.G.3. of the CY 2025 PFS 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 (see also section XXX of the CY
2025 PFS proposed rule), this new APCM code set can 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,\108\ the practice and
sustainability of the primary care sector is under significant
strain.\109\ 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 \110\ care
relationships over time.\111\ 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.\112\ 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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\108\ National Academies of Sciences, Engineering, and Medicine
(NASEM); Implementing High-Quality Primary Care (https://nap.nationalacademies.org/read/25983).
\109\ 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).
\110\ 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.
\111\ NASEM, Implementing High-Quality Primary Care (https://nap.nationalacademies.org/read/25983).
\112\ 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 was 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
[[Page 97903]]
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.113 114
(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.\115\ 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.\116\
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\113\ 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.
\114\ 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.
\115\ 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.
\116\ 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 explored 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 the CY 2025 PFS proposed
rule, we proposed 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 sought 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
interested parties to lay the path for a more transparent movement to
value-based care. Specifically, we requested 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 encouraged input on the questions in this section from diverse
voices, including beneficiaries and advocates, community-based
organizations, providers, clinicians, researchers, unions, and all
other interested parties. We plan to summarize comments received in
response to our Advanced Primary Care RFI in a separate publication,
which we intend to make available via the Medicare Physician Fee
Schedule website (https://www.cms.gov/medicare/payment/fee-schedules/physician). Below is a description of the solicitation and questions
posed in the RFI.
b. Solicitation of Public Comments
We sought 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 (in section II.G.2. of the CY 2025 PFS 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 will 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
sought 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 sought to create a stepping stone 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 sought 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
[[Page 97904]]
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.\117\ 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.\118\
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\117\ 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.
\118\ 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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For these reasons, we sought to understand how advanced primary
care hybrid payments can balance program integrity, high-quality care,
payment stability, and clinician burden.
We sought 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.\119\ 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 sought 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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\119\ 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 sought 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
[[Page 97905]]
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.'' \120\ 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.\121\ 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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\120\ https://www.cms.gov/pillar/health-equity.
\121\ 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 \122\ and Making Care Primary \123\
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 sought input
on how advanced primary care billing and payment policy could be used
to reduce health disparities and social risk. Furthermore, we sought 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.\124\
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\122\ https://www.cms.gov/priorities/innovation/innovation-models/aco-reach.
\123\ https://www.cms.gov/priorities/innovation/innovation-models/making-care-primary.
\124\ 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 sought 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?
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 sought 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, registration for and
reporting of the ``Value in Primary Care'' MVP would be an APCM service
element for MIPS eligible clinicians. 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 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
[[Page 97906]]
advanced primary care practices to bill for advanced primary care?
Most commenters responding to the Advanced Primary Care RFI were
generally optimistic about the future of advanced primary care but
cautioned that fee-for-service payments are still necessary for certain
services. While several commenters expressed concern about
administrative burden, many commenters also noted that capacity
building investments could provide significant support to providers new
to longitudinal care. Furthermore, a few commenters expressed the need
for increased payment for primary care and provided recommendations of
alternative sources of data for determining hybrid payment rates. Some
commenters preferred to restrict APCM billing to ACOs or total cost of
care models. Lastly, many commenters supported waiving cost sharing,
incorporating patient-reported outcome measures, including health
equity factors (social risk adjustments, stratifying quality data) and
increasing integration of behavioral health.
We appreciate the support for our efforts to understand how we
might build and evolve over time advanced primary care hybrid payments.
We will continue to review feedback in response to the Advanced Primary
Care Hybrid Payment RFI as it pertains to future rulemaking.
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.\125\ The burden of
CVD is unequal, with black Americans experiencing higher rates of CVD-
related morbidity than white Americans.\126\ Atherosclerotic CVD \127\
is also distinct among leading causes of death for Americans in the
proportion of CVD attributable to behavioral causes,\128\ 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.\129\
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\125\ 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.
\126\ 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.
\127\ What is Atherosclerosis? NIH NHLBI. https://www.nhlbi.nih.gov/health/atherosclerosis.
\128\ 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.
\129\ 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 \130\ (hereafter referred to as
Million Hearts[supreg] model) was launched in 2017 as part of the
ongoing HHS Million Hearts[supreg] Initiative.\131\ 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.\132\ In
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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\130\ 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.
\131\ 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/.
\132\ 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.
---------------------------------------------------------------------------
All CMS Innovation Center models are independently evaluated \133\
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.\134\ 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).\135\
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\133\ 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.
\134\ 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.
\135\ 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.
---------------------------------------------------------------------------
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),\136\ as well as a
longitudinal re-assessment tool used within the model.\137\ 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.\138\
---------------------------------------------------------------------------
\136\ 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/.
\137\ 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.
\138\ 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
[[Page 97907]]
panel).\139\ 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.\140\ 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.\141\
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\139\ 2019 ACC/AHA Primary Prevention of Cardiovascular Disease.
https://www.ahajournals.org/doi/pdf/10.1161/CIR.0000000000000678.
\140\ 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.
\141\ 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 proposed
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 proposed a new stand-alone G-code, HCPCS code G0537 (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 proposed 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 proposed 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 will 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/alcohol/drug use,
pre-diabetes, or diabetes. We further proposed that the ASCVD risk
assessment will not be separately billable for patients with a
cardiovascular disease diagnosis or those who have history of a heart
attack or stroke.
We did not propose any specific tool that will 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 \142\ and the AHA PREVENT tool.\143\ CMS expects
that the tool that is used would not introduce discriminatory bias,
consistent with Section 1557 final rule.
---------------------------------------------------------------------------
\142\ 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.
\143\ 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.
---------------------------------------------------------------------------
We proposed for HCPCS code G0537 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 requested comments on these proposals, as well as information
pertaining to potential clinician education for these proposed codes.
We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: Overall, commenters were supportive of establishing a
payment mechanism for cardiovascular risk assessment and the proposed
coding to improve cardiovascular health for beneficiaries. Commenters
were generally in support of our proposed required domains of the ASCVD
risk assessment tool. We received a few
[[Page 97908]]
requests to require other domains, such as coronary calcium score.
Response: We remind commenters that, as stated in the code
descriptor for ASCVD risk assessment, ``billing practitioners may
choose to assess for additional domains beyond those listed above if
the tool used requires additional domains.'' We are also not requiring
the use of any specific ASCVD risk assessment tool. After consideration
of public comments, we are finalizing the required elements of the
ASCVD risk assessment as proposed.
Comment: Commenters pointed out that the PREVENT tool is an AHA
tool, not an ACC tool as we stated in the proposed rule.
Response: We thank commenters for pointing out the error, and have
accordingly revised the discussion in this final rule.
Comment: Many commenters requested that the ASCVD risk assessment
not be required to be furnished on the same date as the associated E/M
visit since practitioners may not have the necessary laboratory data on
the same date as the E/M visit.
Response: We agree with commenters that there are circumstances
where test results may identify the need for an ASCVD risk assessment
on a day other than the date of an E/M service, so are not finalizing
the requirement that the ASCVD risk assessment must be performed on the
same date as the associated E/M visit. We continue to believe that in
most cases, HCPCS code G0537 would not be performed in advance of the
associated E/M visit. We reiterate that the ASCVD risk assessment code,
HCPCS code G0537, when performed in conjunction with an E/M visit is
not designed to be a general screening, but rather tied to at least one
predisposing condition to cardiovascular disease that may put the
patient at increased risk for future ASCVD diagnosis. We are finalizing
the code descriptor to align with this change, which will now read:
``Administration of a standardized, evidence-based Atherosclerotic
Cardiovascular Disease (ASCVD) Risk Assessment for patients with ASCVD
risk factors, 5-15 minutes, not more often than every 12 months.''
Comment: Commenters requested that we provide an exclusionary list
of predisposing conditions to cardiovascular disease or a list of
compounding risk factors that may put patients at increased risk for
future ASCVD diagnosis since there may be a wide range of severity and
complexity of the beneficiaries' risk factors.
Response: We do not generally provide exclusionary lists of risk
factors and/or diagnoses so as not to interfere with the practice of
medicine. It is up to the practitioner to determine if the patient's
risk factors, such as obesity, a family history of CVD, a history of
high blood pressure, a history of high cholesterol, a history of
smoking/alcohol/drug use, pre-diabetes, or diabetes, may put the
patient at increased risk for future ASCVD diagnosis.
Comment: We received comments requesting clarification on the types
of practitioners who can administer the ASCVD risk assessment.
Response: We believe these services would typically involve direct
contact between the patient and the billing practitioner or billing
practitioner's auxiliary personnel who administers the assessment.
Typically, CMS does not specify specific specialty codes for billing
services, and in this case, CMS expects this code to be frequently
billed both by primary care providers and specialists (that is,
cardiologists), but other specialists can furnish these services if all
other requirements are met. Because the ASCVD risk assessment must be
associated with an E/M visit, the practitioners who can bill for ASCVD
risk assessment services are limited to those who can furnish E/M
services.
Comment: We received comments requesting changes in the requirement
that the ASCVD risk assessment can only be furnished ``not more often
than every 12 months'' per beneficiary in cases where a different
practitioner may need to furnish the risk assessment to furnish
appropriate ASCVD risk management services. For example, if a
beneficiary's primary care practitioner conducted the ASCVD risk
assessment and they were determined to be at high risk for a future
ASCVD diagnosis, the primary care practitioner may feel the need to
refer the beneficiary to a cardiologist to finish ASCVD risk management
services. If needed, the cardiologist could furnish another ASCVD risk
assessment and ASCVD risk management services if they also determined
the beneficiary to be at increased risk.
Response: We agree with commenters about this concern. We are
finalizing that the ASCVD risk management service can be furnished not
more often than once every 12 months per practitioner per beneficiary.
We expect that this service is only furnished by practitioners who
furnish the bulk of the beneficiary's care, and as this service is for
Medicare beneficiaries without a previous diagnosis of coronary artery
disease, it may be most frequently billed by primary care, but some
beneficiaries may also have a cardiologist for other cardiovascular
conditions predisposing to ASCVD. We would like to reemphasize that the
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 and is not
separately billable for patients with a cardiovascular disease
diagnosis or those who have history of a heart attack or stroke.
After consideration of public comments, we are finalizing the code
descriptor for G0537 ``Administration of a standardized, evidence-based
Atherosclerotic Cardiovascular Disease (ASCVD) Risk Assessment for
patients with ASCVD risk factors, 5-15 minutes, not more often than
every 12 months per practitioner.'' We are finalizing all other aspects
of G0537 as proposed.
(1) Valuation for ASCVD Risk Assessment G0537
We proposed 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 the proposed HCPCS code G0537. Therefore, we proposed a
work time of 15 minutes for HCPCS code G0537 based on this same
crosswalk to G0136. We also proposed to use this crosswalk to establish
the direct PE inputs for HCPCS code G0537.
We sought comments on these proposals. We received public comments
on these proposals. The following is a summary of the comments we
received and our responses.
Comment: Commenters were generally in support of our proposed
valuation of ASCVD risk assessment services (G0537). Some commenters
suggested that the valuation should be increased, as they stated that
the proposed crosswalk HCPCS code G0136 is undervalued.
Response: We believe the crosswalk to G0136 is an appropriate
crosswalk because these services are clinically similar standardized
risk assessments that take 5-15 minutes. If commenters believe that
HCPCS code G0136 is undervalued, we welcome information from interested
parties on a more accurate valuation that we may consider for future
rulemaking. Individuals and groups may submit codes for review under
the potentially misvalued codes
[[Page 97909]]
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.
After consideration of public comments, we are finalizing the
valuation of G0537 as proposed.
c. Atherosclerotic Cardiovascular Disease Risk Management Services
(G0538)
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 proposed 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 proposed new G-code, G0538 (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 proposed that the elements of the Atherosclerotic
Cardiovascular Disease (ASCVD) risk management service will 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 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 will not be
addressed for a patient who does not use tobacco. Documentation of each
service element in the patient's medical record is required.
Comment: Commenters were generally supportive of the proposed
elements of the ASCVD risk management service. We received requests to
include the use of blood pressure medications in the medication
management service element.
Response: We clarify that medication management is not limited to
the examples of aspirin and statins that were listed in the proposed
rule but could include other medications needed to maintain or decrease
risk of CVD.
After consideration of public comments, we are finalizing the
service elements for G0538 as proposed.
Physicians and non-physician practitioners (NPPs) who can furnish
E/M services could bill for ASCVD risk management services. We
anticipate that ASCVD risk management services will 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 proposed that ASCVD risk management services will 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 proposed that patient consent must be obtained before starting
ASCVD risk management services. Like other care management services,
ASCVD risk management services will 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 proposed that ASCVD risk management services can 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 sought comments on each of these proposals.
We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: We received many comments requesting clarification on
whether concurrent billing of other services would be allowed with
G0538. Some of the examples provided by commenters were care management
services, Self-Measured Blood Pressure (SMBP) (99473-99474), G0446
[[Page 97910]]
(Intensive Behavioral Therapy for Cardiovascular Disease), and Smoking
and tobacco use cessation counseling visits (99406-99407).
Response: Concurrent billing with G0538 would be allowed during the
same month if time and effort are not counted more than once,
requirements to bill both services are met, and the services are
medically reasonable and necessary. We would like to remind
practitioners that the patient consent requirement for this service
includes informing the patient about potentially applicable Medicare
cost sharing. When G0538 is billed concurrently with preventive
services, like G0446 (Intensive Behavioral Therapy for Cardiovascular
Disease), practitioners should be sure to inform the patient that G0538
is not a preventive service, and that cost sharing may apply.
Comment: We received many comments providing us with further
information about the current clinical practice metrics for identifying
patients at medium to high risk of CVD. Many standardized, evidence-
based risk assessment tools use different percentage ranges that may
fall outside of the proposed ``>15 percent in the next 10 years.'' Many
current tools identify ``intermediate risk'' as 7.5%-19.9% and ``high
risk'' as >20%. Commenters also believed that this specific designation
may not align with changing clinical recommendations for cardiovascular
risk intervention.
Response: The elements of G0538 were designed with the findings
from the Million Hearts[supreg] model in mind, and so the specific risk
percentiles used in the model were included in the proposed rule. We
acknowledge that clinical practice evolves over time and the
categorization of risk percentiles into categories of risk may also
evolve as risk prediction tools and clinical guidelines are refined. We
note the most recent 2019 AHA/ACC clinical guidelines for primary
prevention of cardiovascular disease establish (distinct from the
Million Hearts[supreg] model) categories of `low risk,' `borderline
risk,' `intermediate risk,' and `high risk,' and these categories may
evolve over time as well. For these reasons, we will remove the risk
management threshold percentile from the code description for G0538
services, given that the intent of the Million Hearts[supreg] model was
to identify patients commonly considered to be at intermediate (or
medium) or high risk of ASCVD for G0538 services.
After consideration of public comments, we are finalizing G0538
with the following code descriptor, ``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 intermediate, medium, or high risk for CVD 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.'' We are finalizing all other policies for G0538 as
proposed.
(1) Valuation for ASCVD Risk Management Services (G0538)
We proposed 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 G0538. CPT code 99211 has a
physician intraservice time of 5 minutes, and the physician work is of
similar intensity to our proposed HCPCS code G0538. Therefore, we
proposed a work time of 5 minutes for HCPCS code G0538 based on this
same crosswalk to CPT 99211. We also proposed to use this crosswalk to
establish the direct PE inputs for HCPCS code G0538, 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 sought comments on these proposals.
We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: Commenters were generally in support of our proposed
valuation of ASCVD risk management services (G0538).
Response: After consideration of public comments, we are finalizing
the work RVU of 0.18 and our proposed PE inputs for G0538.
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
[[Page 97911]]
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 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,\144\ and all but one
State for OTAs.
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\144\ Federation of State Boards of Physical Therapy
Jurisdiction Licensure Reference Guide https://www.fsbpt.net/lrg/Home/SupervisionRequirementLevelsBySetting.
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Some interested parties have reported that allowing for general
supervision of OTAs and PTAs by OTPPs and PTPPs, respectively, would
allow for patients to have increased access to outpatient therapy
services, even with ongoing healthcare workforce shortages. The
shortages of OTs \145\ and OTAs,\146\ PTs,\147\ and PTAs,\148\ 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.\149\
Additionally, 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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\145\ 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).
\146\ 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).
\147\ 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).
\148\ 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).
\149\ 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 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,'' \150\ in the CY 2024 PFS proposed rule to
demonstrate that the minimum level of supervision by PTs and OTs for
services performed by PTAs and OTAs working in institutional settings
is a general level of supervision, in accordance with various
regulations (88 FR 52359). Therefore, we believe that a change from
direct to general supervision would allow OTPPs and PTPPs the
flexibility to better accommodate patients' availability and act to
ensure access to necessary therapy services. A change from direct to
general supervision would also allow OTPPs and PTPPs to bill and
receive Medicare payment for therapy services furnished by their OTAs
and PTAs when they are not in the office or patient's home at the same
time.
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\150\ 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.
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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
[[Page 97912]]
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 proposed 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 will 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 revised policy will parallel the 44
States that allow general supervision of PTAs and the 49 States that
allow general supervision of OTAs (most often described by States as
requiring the PT or OT to be in touch via telecommunication). For the
States with more restrictive supervision levels, such as direct
supervision, Medicare-covered therapy services provided in those States
are required to be furnished in compliance with State law. We note that
while we proposed to allow for general supervision by OTPPs and PTPPs
of their OTAs/PTAs, an OTPP or PTPP will 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 solicited comment on our proposals.
We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: Many commenters supported our proposal to change the
required level of supervision of PTAs and OTAs in PT and OT private
practices from direct to general supervision. Many of these commenters
cited potential benefits including increased patient access to therapy
services, alignment with State laws and practice acts and reduced
administrative burdens. Other commenters appreciated the proposal for
general supervision because it would provide greater flexibility in
scheduling and resource allocation--allowing PT and OT clinics to
address staffing shortages, particularly in rural areas, since the
therapists and therapy assistants no longer need to both be onsite to
treat Medicare patients. Some commenters supported our proposal because
consistent general supervision policies across all Medicare therapy
settings will decrease administrative burden and confusion. Many
commenters informed us that providers have demonstrated the ability to
provide safe and effective care for many years with general supervision
of PTAs and OTAs in other Medicare therapy settings and believe these
safeguards will protect patients in the private practice setting. A few
commenters thanked us for the general supervision proposal, since some
of the institutional settings with general supervision, for example,
home health agencies (HHAs) and SNFs, include patients with more
complex conditions than those in private practice settings where direct
supervision is required. One commenter supported our proposal for
general supervision as they believe this change could increase
employment opportunities for their graduates and allow them to better
serve patients in their communities. We heard from several other
commenters that suggested this change in supervision could result in
Medicare savings--up to an estimated $271 million over 10 years--based
on a 2022 report by Dobson DaVanzo & Associates commissioned by therapy
organizations.\151\ One of these commenters that believes the analysis
presents convincing data that general supervision in private practices
would create significant savings, even if the supervision change
resulted in a modest increase in therapy service, is that some services
of the PT would shift to the PTA--resulting in a greater percentage of
claims for services furnished by PTAs being paid at 85 percent of what
we otherwise make to the therapist under the PFS when those services
are furnished in whole or in part by a PTA.
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\151\ See report at: https://www.dobsondavanzo.com/index.php?src=directory&view=Publications&submenu=_pubs&category=Cost%20Estimation&srctype=Publications_lister_redesign.
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Response: We appreciate the support for our proposed policy from
the many commenters.
Comment: One commenter expressed concerns over potential risks to
patient safety, quality of care, lost professional development
opportunities, lack of consistency in treatment, and legal and ethical
issues, recommending the retention of the direct supervision policy.
Response: PTAs and OTAs, who are State-licensed or State-regulated
professionals, will continue to be required to comply with their
respective State laws, and work under the direction of the PT or OT in
private practice, which sufficiently safeguards patients' safety and
quality of care. We do not believe that a change to general supervision
will affect the consistency in treatment delivery of therapy services
under the physical therapy or occupational therapy plan of care; nor
will it create gaps in training and development of PTAs and OTAs by
their supervising PTs and OTs. Further, we do not agree with the
commenter that the change to general supervision where it is permitted
under State law will cause a change in the way therapists or therapy
assistants fulfill their legal obligations or comply with ethical
standards.
After consideration of public comments, we are finalizing as
proposed the revisions to 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 believe that this policy will increase access to therapy
services and more closely align Medicare policy with the majority of
State practice acts for occupational therapy and physical therapy. In
States with more restrictive supervision levels, such as direct
supervision, Medicare-covered therapy services provided in those States
are required to be furnished in compliance with State law.
2. Certification of Therapy Plans of Care With a Physician or NPP Order
Sections 1861(p), (g), and (ll)(2) of the Act define outpatient
physical therapy services, outpatient occupational therapy services,
and outpatient speech-language pathology services as services provided
to an individual outpatient who 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 therapist providing
such services, and is periodically reviewed by the physician; and (c)
the services are or were furnished while the individual is or was under
the care of a physician.
[[Page 97913]]
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-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, which would include a physician or other
practitioner, or an entity other than a provider, that furnishes health
care services under Medicare.\152\ See Medicare Benefit Policy Manual,
Pub. 100-02, chapter 15, sections 220.1, 220.1.2, and 220.1.3 for
references to Sec. 424.24. 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.
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\152\ 42 CFR 400.202.
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Due to the foregoing concerns, we proposed to revise the headings
of paragraphs (c) introductory text and (c)(1)(i) to include the term
``occupational therapy'' after physical therapy. We proposed to replace
the term speech pathology with the accepted term speech-language
pathology in 42 CFR 424.24(c)(1)(i). We also proposed 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 reminded 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
specified 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, 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 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
[[Page 97914]]
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 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 10 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 proposed 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 will 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 will 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
proposed to carve out an exception to the physician signature
requirement at Sec. 424.24(c) by adding a new paragraph (c)(5). The
policy will 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 did not propose
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 will 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 policy will 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 proposed to make clear in 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 welcomed comments on this proposal.
We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: One commenter supported our technical revisions to Sec.
424.24(c) to specifically include occupational therapy services under
the certification requirements and to add the services of an
occupational therapist, in addition to physical therapists and speech-
language pathologists, as these revisions more clearly identify that
the certification requirements outlined in Sec. 424.24(c) apply to the
outpatient therapy services furnished by OTs.
Response: We thank the commenter for their support.
Comment: Several commenters expressed support for our proposal to
accept a physician's or NPP's signed and dated order as equivalent to a
signature on the initial certification of a therapist-established plan
of treatment
[[Page 97915]]
in cases where the written order or referral from the patient's
physician/NPP is on file and the therapist has documented evidence that
the treatment plan was transmitted to the physician/NPP within 30 days
of the initial evaluation. They stated this change will reduce
administrative burden for therapists and physicians/NPPs, as well as
encourage more timely and efficient care delivery. Many of these
commenters urged us to finalize the proposal so that they would no
longer have to waste time and resources tracking down physicians who
fail to return signed plans of care and added that the proposed
exception to the signature requirement, if finalized, would greatly
reduce uncertainty of payment, in addition to reducing administrative
burden.
Response: We thank the commenters for their supportive comments.
Comment: A few commenters expressed concerns. One commenter stated
that before we make any changes to the certification process, we should
consider the roles and contributions of each health care provider
involved in the patient's care plan and ensure that the physician is
still the head of the care team, while not hindering access to needed
therapy.
Response: PTs, OTs, and SLPs are all practitioners of outpatient
therapy services and while coverage for outpatient therapy services
relies on the patient being under the care of a physician, these
practitioners do not require the supervision of physicians or NPPs to
furnish Medicare-covered therapy services. However, the plans of care
that therapists establish require the signature of the physician, NP,
PA, or CNS who has knowledge of the case. As such, the care plan team
consists of the physician or NPP and the therapist. This care plan team
is the same as the one that currently exists for treatment plans
requiring the physician/NPP signature for certification and will remain
unchanged once our proposal to amend the certification regulations is
finalized.
Comment: Some commenters agreed with our proposal to recognize the
signed and dated order for only the initial certification and that the
existing signature requirements should be kept for certifications when
the patient does not have an order or referral and for all
recertifications irrespective of a whether the patient has a referral.
Several commenters suggested that the recertification should also be
included as part of our proposal, while a few other commenters, perhaps
misunderstanding our proposal, stated that they supported our proposal
for both the certification and recertification of treatment plans. One
commenter asked that we confirm our proposed policy.
Response: We are confirming that our proposed policy as noted in
the CY 2025 PFS proposed rule (89 FR 61739) would only apply to the
certification in those cases where the patient has an order or referral
for physical therapy, occupational therapy, or speech-language
pathology services; and, stress that we did not propose, nor did we
intend to establish an exception to the signature requirement for
purposes of recertification of therapy plans of treatment. In cases
when the patient does not have a written order or referral from their
physician/NPP, the POC signature requirement for certifications would
still apply, as we proposed at Sec. 424.24(c)(5).
Comment: Several commenters asked CMS to make the policy in this
proposal clear to our contractors (MACs), that is, the specifics of
what we included in the CY 2025 PFS proposed rule (89 FR 61739): ``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.'' They additionally
asked that we notify our MACs/contractors through a formal program
memorandum prior to the policy becoming effective on January 1, 2025,
stating that physician signature requirement for the POC certification
has been a frequent targeted area for denials and oversight.
Response: The proposed exception to the signature requirement would
take effect for dates of service on and after January 1, 2025, based on
the date of the therapist's initial evaluation (which begins the
episode of care); and we would plan to notify our contractors of the
policy changes to the certification process through our usual change
management process using the same or similar language suggested by the
commenters.
Comment: Several commenters asked us to provide a comprehensive
list of all the acceptable ways that the plan of care can be delivered/
transmitted to the physician/NPP. Three of these commenters gave
examples of the methods of delivery that their members and/or staff
have utilized in the past. Their collective list includes the
following: electronic health record (EHR) systems (with a time stamp)
and electronic signatures, other electronic means, facsimile sheets/
logs, paper records and paper logs (for example, physicians providing
signatures at the nursing desk in a facility), electronic date stamps,
call logs, tracking forms, and those POCs hand delivered to physicians
(including to physicians in their offices or during weekly rounds in
the facility). Two of these commenters stated that CMS must convey to
the MACs that all of these methods of documentation are acceptable. One
commenter asked CMS to confirm if facsimile logs or other electronic
means could be accepted as evidence that the POC was submitted/
transmitted to the referring physician/NPP.
Response: We have not established and are not aware of a
comprehensive listing of ``acceptable'' delivery mechanisms. However,
since policies relating to POC delivery/transmission to the physician/
NPP have been in place for many years, we will direct our contractors
to continue to accept the same methods of delivery as they have in the
past.
Comment: Several commenters requested that we issue clarifying
guidance materials to ensure the ordering/referring physicians and
treating therapists are fully aware of the information that must be
included in the order or referral.
Response: As we stated in the proposed rule, the order or referral
must be written, dated and signed by the ordering or referring
physician/NPP and include the type of therapy--physical therapy,
occupational therapy, or speech-language pathology--the patient
requires. We are clarifying here that we would also expect the order or
referral to include information to identify the beneficiary and
ordering/referring physician/NPP.
Comment: Two commenters informed us that they believe there is a
difference between the terms order and referral--stating that a
referral is broadly inclusive of the more specific term ``order'' that
might contain specific treatment specifications (for example, duration,
frequency) and would be treated functionally the same as a referral
broadly specifying the need for therapy services. They pointed out that
the Medicare Benefit Policy Manual (MBPM) contains the term ``order'',
and it may be confusing if the regulation and MBPM terminology differ.
These commenters stated that they would like us to use only one term,
``referral'', ``order'' or ``order/referral'', preferably ``referral'',
for this policy and regulation and related MBPM sections for therapy
services that they claim will be helpful to PTs who use the MBPM to
learn about and understand our policies.
Response: We thank the commenters for their remarks. As we have
used the ``order or referral'' and ``order/referral'' terminology
throughout this rulemaking
[[Page 97916]]
for our proposed exception to the signature requirement policy, we will
continue to use it here and in the regulation text at Sec.
424.24(c)(5). We agree that our Medicare Benefit Policy Manual (MBPM),
Pub. 100-02, chapter 15, should conform with the regulation and, as
such, we will revise the manual in section 220, to reflect that the
terms ``order or referral'' can be used interchangeably.
After consideration of public comments, we are finalizing our
proposal to amend the certification regulations at 42 CFR 424.24(c) to
provide an exception to the physician/NPP signature requirement on the
therapist-established treatment plan for purposes of the initial
certification in cases where a written order or referral from the
patient's physician/NPP is on file and the therapist has documented
evidence that the treatment plan was transmitted to the physician/NPP
within 30 days of the initial evaluation. We are also finalizing the
regulation text at Sec. 424.24(c), as proposed for paragraphs (c),
(c)(1)(i), and (c)(3)(ii). We are finalizing the added paragraph (c)(5)
with a modification to replace the term ``plan of care'' with ``plan of
treatment.'' We recognize that we have used the term ``plan of care''
and ``POC'' in our preamble discussion in the CY 2025 PFS proposed rule
and in this final rule, and consider ``plan of care'' and ``plan of
treatment'' to have the same meaning. However, we are substituting the
term ``plan of treatment'' for ``plan of care'' in the regulation to be
consistent with the other uses of plan of treatment found at Sec.
424.24(c). We will be implementing this exception to the signature
requirement policy and the clarifications added above via our usual
change management process to our contractors.
In addition, we solicited comments to gather more information about
the need for a regulation that will 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 we allow physicians/NPPs to have
just 10 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).
We received public comments on this comment solicitation. The
following is a summary of the comments we received and our responses.
Comment: Many commenters supported having a 10-business day window
of opportunity for the physician or NPP to provide modification to the
plan of care while some of these commenters stated that 10 business
days was a reasonable timeline for the physician/NPP to make changes to
the patient's POC. One commenter supporting the 10-business day
timeline expressed concern that POC communications about his/her
patients to and/or from the smaller therapy provider without a robust
EHR system may prove challenging.
Response: We thank the commenters for their comments.
Comment: Several commenters did not support the 10-business day
window. One commenter stated that the NPP may not be able to respond
within 10 days, and could determine that a modification is necessary
after a later review. Another commenter opposed any limitation on the
physician's ability to modify the plan of care stating that his/her
order/referral in these cases means that they are relinquishing their
ability to direct the patient's care, including those occasions when
during the episode of care a patient sees the physician with a change
in their condition that necessitates a modification. Another commenter
voiced concern about establishing restrictive time limits for
physicians/NPPs to make POC modifications since none exist currently
and they recommend we maintain standing policy until more input is
gathered from stakeholders.
Response: We thank the commenters for their comments.
Comment: A few commenters stated that allowing 10 days for a
physician to provide modification to the POC was too long. One
commenter pointed out that this 10-day window is a disservice to
patients since it could postpone healing, pain relief, or receipt of
other needed care including increased mobility; and it could complicate
scheduling appointments that will accommodate them and their
caregivers.
Response: We thank the commenters for their comments.
Comment: Many commenters urged us to clarify that physician/NPP
modifications to therapy POCs are only applied on a prospective basis
and asked us to guarantee payment for those therapists' services
provided prior to a physician/NPP modification to the POC as the
patient was under the care of a physician/NPP. They believe that prior
to the modification of the POC, the therapy services provided to the
patient met Medicare requirements for reimbursement--being both
medically necessary and under the care of a physician. The commenters
further stated unless we ensured payment for the therapy services
furnished prior to the POC being modified by the physician/NPP,
therapists would continue to have to decide, just as they do now,
whether to risk providing timely care or waiting 10 days before
providing therapy services to avoid nonpayment for a modification. We
also heard from many therapist commenters who told us they believe the
10-day window both guarantees payment for their services and allows
physicians/NPPs the opportunity to provide input to the POC without
impeding the provision of timely therapy services. One commenter stated
that the time limit was not needed at all if we were to guarantee
payment for services prior to physicians/NPPs modification of the POC
during the episode of care.
Response: We thank the commenters for their comments.
Comment: One commenter stated their support for the 10-day review
policy; however, they also stressed that it is important to preserve
existing processes that allow therapists and physicians to work closely
together to deliver medically necessary care. Currently, physicians may
request changes to POCs at any point throughout the episode of care and
the therapist will adjust the POC based on the physician's
recommendation. If we finalize the 10-day window review policy, the
commenter suggests we view the 10-day review period as an opportunity
for establishing the physician's immediate feedback and that it does
not preclude their ability to provide future input later in the
episode.
Response: We appreciate the commenters' remarks as to the
importance of maintaining the ability of the physician/NPP to make
changes to a patient's POC outside of the 10-day window, as noted at
Sec. 410.61(d), if we were to adopt this 10-day window policy.
Comment: Two commenters requested that we clarify how the
physician-modified POC is treated once the therapist has adjusted the
POC and sent it back to the referring physician/NPP. They both question
whether the modified POC ``presumptively'' meets the signature
requirement because the physician input has been incorporated; while
one of these commenters also asked if the amended POC requires a
physician signature or whether the new POC is subject to the same
exception requirement and if the 10-day review period restarts from the
date the new
[[Page 97917]]
POC was transmitted back to the physician.
Response: The fact that a physician/NPP has modified the POC does
not alter the fact that the POC was first established by the therapist
at the beginning of the episode of care with an order/referral from
that physician/NPP which is maintained in the patient's medical record.
If we were to adopt the 10-business day window policy, we would
continue to treat the modified plan of care as meeting the exception to
the signature requirement, unless the physician/NPP returns the POC
with the modifications to the therapist signed, at which point it meets
the signature requirement and the exception would not be needed.
Comment: One commenter stated that we should educate the MACs well
in advance of the effective date of these new policies and suggested we
consider a formal program memorandum to do so. They stated that the
MACs have singled out the signature requirement for the POC
certification most frequently for denials and oversight, citing
examples of the Targeted Probe and Educate program and claims audits.
These commenters requested that we ensure that the new finalized
policies are understood by our contractors in advance of claims
processing for 2025.
Response: Currently, MACs primarily perform prepayment review after
claims from therapists or providers are submitted and prior to claims
processing. However, the physician/NPP signature itself does not
represent medical necessity or ensure payment for the therapy service
whether it's on the order/referral or on the POC without an order--in
these prepayment review cases, the MACs would look at the therapy
services provided to determine their medical necessity. The physician/
NPP order/referral would demonstrate the intent for the skilled
service, which should then be reflected in the therapist-established
plan of care. We will implement these provisions using our usual change
management process to provide instructions to contractors and make
manual revisions to the applicable sections of the MBPM, chapter 5.
After consideration of public comments, we express appreciation for
the feedback from commenters and will take the comments into
consideration for possible future rulemaking.
We acknowledge the concerns raised by commenters about payment for
any therapy services furnished prior to a physician/NPP modifying a
plan of care. We agree with commenters that payment should be made for
such therapy services if all applicable payment requirements, including
medical necessity, are met. We are clarifying that whenever a
physician/NPP amends the therapist-established POC at any point during
the patient's episode of care, payment determinations for services
provided by the therapist prior to the amendment should be based on the
POC that had been timely submitted to the physician/NPP who had written
the order/referral, or under a POC without an order/referral submitted
to the physician/NPP with knowledge of the case, and considering all
other applicable payment requirements, including medical necessity.
That said, we remind readers that our final policy, as we noted in the
CY 2025 PFS proposed rule (89 FR 61739), will not affect a contractor's
ability or authority to determine whether therapy services are
reasonable and necessary for a given beneficiary; and, as noted above,
the same medical necessity requirements are applied for POCs
established with and without orders, with the exception that for those
POCs established with an order, the medical reviewers may additionally
look for documentation in the patient's medical record of the written
order/referral and evidence that the POC was submitted to the
physician/NPP within 30 days of the therapist's evaluation. We believe
that our finalized policy to permit the physician/NPP written order/
referral for therapy services to substitute for the signature on the
initial certification of the therapist-established treatment plan, will
allow therapists to provide therapy services without any delay and at
the same financial risk that he/she would have after receiving, after a
period of waiting for, a signed POC from the physician/NPP without an
order. This is because, as we noted above, the physician/NPP signature
itself--whether on the order/referral or on the POC without an order--
does not determine medical necessity or ensure payment for the therapy
service. While the therapist has a 30-day timeline to send the POC to
the physician/NPP writing the order/referral, sending the POC to the
physician/NPP as soon as it is established would allow a MAC conducting
medical review on a prepayment basis to be able to see the order on
file and evidence that the POC had be sent to the physician/NPP in a
timely manner while reviewing all documentation in order to determine
the medical necessity of the POC and services provided. Additionally,
we reiterate what we stated in the CY 2025 PFS proposed rule (89 FR
61739), and wish to clarify in this final rule, and at Sec.
424.24(c)(5) with a minor amendment, that any reference to an order or
referral at Sec. 424.24(c)(5) cannot be construed to require an order
or referral for outpatient physical therapy, occupational therapy, or
speech-language pathology services. As we noted in the above section,
we will implement these provisions using our usual change management
process to provide instructions to contractors and make manual
revisions to the applicable sections of in the Medicare Benefit Policy
Manual, Pub. 100-02, chapter 15, Sections 220 and 230. We are also
considering providing education to therapy providers through a separate
article should the usual education correlating to the program
instruction with manual changes not be available until after the new
policy takes effect on January 1, 2025.
Additionally, we solicited 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
previously--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 sought feedback about whether
this limit, or one of a different duration, should be incorporated into
the regulatory provision we proposed previously for Sec. 424.24(c)(5).
We received public comments on this comment solicitation. The
following is a summary of the comments we received and our responses.
Comment: Some comments voiced opposition to the 90-day limitation
we discussed in the comment solicitation. One commenter stated 90 days
was too short and suggested a 6-month limit as more reasonable. Another
commenter stated a 90-day limit to physician referrals would pose
significant problems for certain patients whose physicians write
referrals for therapy at the same time they order surgery, and by the
time the patient is able to start therapy the referral could be older
than 90 days--taking into consideration time for the surgery to be
scheduled followed by a recovery period when needed. This commenter
also said that having to implement different workflows for the
referrals over 90 days would be difficult to manage. One commenter
stated their concerns about the creation of a 90-day limit on orders/
referrals that would be used specifically for purposes of the exception
to the signature requirement on POC certification as it would create
confusion and administrative burden
[[Page 97918]]
and may limit patients from receiving timely therapy services. Two
commenters stated that workforce distribution has created variable
staffing challenges across the country and believes that a backlog of
referrals may exist in some states that typically results in therapy
being scheduled months in advance--sometimes having to schedule new
patients over 90 days after they received the referral. This commenter
stated that they believe that a 90-day limit would overcomplicate the
ability of these staffing-challenged therapy clinics because they would
have the added burden of tracking down physician signatures and could
have benefitted from the certification policy without the 90-day order
limit. Both commenters suggested that we could reconsider this policy
in the future should the agency determine that a significant amount of
therapy is initiated beyond 90 days.
Response: We thank the commenters for their comments.
Comment: Several commenters supported the 90-day limit to the
order/referral for these therapy services. Two of these commenters
stated that a greater than 90-day period between the order/referral and
the receipt of therapy might result in changes the patient's condition
that could potentially require the referring physician/NPP to
reevaluate or reassess the patient's condition in order to provide
needed additional direction to the therapist. One of these commenters
stated that their support for the exception to the signature
requirement policy is contingent upon the adoption of the 90-day time
limit on the physician order/referral.
Response: We thank the commenters for their comments.
After consideration of public comments, we appreciate the feedback
from commenters and will take the comments into consideration for
possible future rulemaking.
We clarify that we did not propose to amend Sec. 424.27 for
comprehensive outpatient rehabilitation facilities (CORFs) 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.
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 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 proposed 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
was estimated to be 3.6 percent and was 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 resulted 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 also proposed to update the MEI increase for CY
2025 based on historical data through the second quarter of 2024, and
we proposed to 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 will 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 multiple
procedure payment reduction (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.
Comment: Several commenters supported the change in the KX modifier
threshold amounts for CY 2025 and urged us to finalize them.
Response: We appreciate the supportive remarks from the commenters.
Comment: One commenter asked us to provide a clarification as to
why we grouped physical therapy and speech-language pathology together
stating they should each have their own distinct threshold.
Response: Section 1833(g) of the Act defines dollar amounts for the
KX modifier thresholds--there is one amount for physical therapy and
speech language pathology services combined and a separate amount for
occupational therapy services--just as with the incurred expenses for
the prior therapy cap amounts. More information about
[[Page 97919]]
the KX modifier threshold amounts can be found on the therapy services
web page in the article titled The Implementation of the Bipartisan
Budget Act of 2018 that is located at https://www.cms.gov/medicare/coding-billing/therapy-services.
We stated in the CY 2025 PFS proposed rule that we would use the
MEI update based on historical data through the 2nd quarter of 2024 to
determine the final MEI percentage increase and the CY 2025 KX modifier
threshold amounts in the CY 2025 PFS final rule. The final CY 2025 MEI
is 3.5 percent based on historical data through the second quarter of
2024. Using this percentage increase results in a KX modifier threshold
amount of $2,410 for physical therapy and speech-language pathology
services combined and $2,410 for occupational therapy services, which
we are finalizing for CY 2025.
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 \153\ and death by
suicide is growing significantly in older adults, who comprise most of
the Medicare population. Among those age 65 and older, the suicide rate
increased 4.5% from 2021 to 2022.\154\ 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.\155\
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\153\ https://www.cdc.gov/suicide/facts/data.html.
\154\ https://wonder.cdc.gov/.
\155\ 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 and response
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 for suicide. 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.\156\ One important aspect of making an
environment safe could be, for example, addressing a person's access to
lethal means, such as firearms, environmental means (including bridges
and tall structures), and medications/drugs.
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\156\ 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).157 158 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[thinsp]=[thinsp]492) to 79.2 percent (n[thinsp]=[thinsp]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]).\159\ 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.\160\
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\157\ https://www.mentalhealth.va.gov/docs/vasafetyplancolor.pdf.
\158\ https://www.mirecc.va.gov/visn19/research/our-research/implementation.asp.
\159\ 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.
\160\ 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 proposed in the CY 2025 PFS proposed rule to
establish separate coding and payment under the PFS describing safety
planning interventions. Specifically, we proposed 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 sought 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 G0560: 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;
[[Page 97920]]
contacting mental health professionals or agencies; and making the
environment safe; (List separately in addition to an E/M visit or
psychotherapy). We welcomed comments on the proposed elements of the
safety planning code.
We proposed to value HCPCS code G0560 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 G0560. For HCPCS code G0560, we assumed a typical time of 20
minutes, resulting in a work RVU of 1.09 (based on one third of the
work value currently assigned to CPT code 90839, which is 3.28). We
welcomed 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
welcomed 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 welcomed comments regarding which clinician types
might be most likely to bill such a code on its own.
We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: Many commenters recommended that we finalize this code as
a standalone code, rather than an add-on code, noting that
practitioners need a way to capture time spent performing safety
planning interventions beyond the initial 20 minutes. Commenters noted
that in settings such as emergency departments, crisis centers, and
primary care, SPI will be conducted on its own at times and at other
times, SPI will be provided in addition to services such as
psychotherapy or E/M services and stated it is essential to establish a
billing mechanism that meets the requirements for each of these
scenarios. They noted that as currently proposed, there is a risk that
additional services that are not required will be conducted to justify
billing this code. Other commenters emphasized that the flexibility to
bill SPI as a standalone service is essential for providing timely
interventions, especially in emergency settings or during critical
periods when a full E/M visit or psychotherapy session may not be
feasible. These commenters also believe that the proposed typical time
of 20 minutes does not accurately capture the typical amount of time
spent with a patient to provide evidence-based safety planning
interventions, noting that 20 minutes would be the minimum and that 20-
45 minutes is typical, while some commenters stated that 45-60 minutes
is typical for adults and 90 minutes would be typical for minors or
adults who require caregiver assistance. Many commenters recommended
that we should allow this code to be billed in units of 20 minutes and
allow up to 6 units per encounter. The commenters state that this would
accommodate the varying needs of patients, ensuring that those
requiring more intensive intervention receive the appropriate level of
care.
Response: We thank the commenters for their feedback. We are
persuaded by the commenters that there may be times when SPI may need
to be furnished as a standalone service, that more time may be needed
to complete safety planning interventions and that one 20-minute code
may not accurately reflect the resource costs involved in furnishing
these services. Therefore, we are finalizing HCPCS code G0560 as a
standalone code that can be billed in 20-minute increments.
Comment: Several commenters stated they believe that there is
sufficient evidence to support trained clinical staff providing this
service under the supervision of the billing practitioner and stated
that restricting the service to only allowing the billing practitioner
to personally provide the service will severely limit uptake and access
for beneficiaries. Several commenters noted that allowing a broader
spectrum of staff to provide SPI mirrors the approach used in clinical
studies and is consistent with how many existing programs operate. Some
commenters stated they agreed that training and practicing within scope
is crucial, and also noted that continued training and education is
also important and cited that most providers who furnished suicide
safety planning desired further training. Other commenters recommended
that we require the same staff qualifications that are required for
mental health community case management and/or mental health community
support under the Medicaid Rehabilitation Option as these positions are
frequently used to provide the same services under Medicaid.
Response: We appreciate the feedback from the commenters on this
issue. While some commenters emphasized the importance of training, we
did not receive specific feedback regarding the nature of the training
that would be needed. We also note that for services furnished in
hospital settings, services provided by clinical staff would not be
separately payable. We are finalizing as proposed that HCPCS code G0560
would need to be personally performed by the billing practitioner for
CY 2025, but we will continue to consider this issue for future
rulemaking. We also note that the billing practitioner could be any
practitioner who is authorized to furnish services for the diagnosis
and treatment of mental illness, including Clinical Social Workers,
Mental Health Counselors, Marriage and Family Therapists, Clinical
Psychologists, as well as physicians and NPPs.
Comment: Some commenters requested that this code be allowed to be
billed when furnished via telehealth.
Response: We thank the commenters for this response. Since HCPCS
code G0560 is similar to other services already on the Medicare
Telehealth list, such as psychotherapy for crisis, we are finalizing
adding HCPCS code G0560 to the Medicare Telehealth list. The full list
of services being added to the Medicare Telehealth list for CY 2025 can
be found Section II.D. of this final rule, Payment for Medicare
Telehealth Services Under Section 1834(m) of the Act.
Comment: A few commenters noted that we acknowledged the increasing
usage of safety plans related to overdose prevention, but pointed out
that the proposed code descriptor reads as if the code is specific to
safety planning to prevent an impending suicidal crisis. The commenters
suggested that we update the code descriptor to reflect ``recognizing
warning signs of an impending suicidal or substance use-related
crisis'' and to update the language regarding contacting professionals
to read, ``contacting mental health or substance use disorder
professionals or agencies.'' Similarly, another commenter also
requested that we update the language regarding utilizing social
contacts and social settings as a means of distraction from suicidal
thoughts to also add the language, ``or risky substance use.'' Other
commenters requested that we add an additional step in the language in
the code descriptor to include reference to a ``crisis narrative'' in
which the patient is asked to describe how they found themselves at a
point where they were thinking of suicide and also, for clarity, to add
the words ``that are documented in a form.''
Response: We thank the commenters for their feedback and note that
we are updating the code descriptor to include ``recognizing warning
signs of an impending substance-use related crisis,'' ``contacting
mental health or substance use disorder professionals or agencies,''
[[Page 97921]]
and adding ``or risky substance use,'' as suggested. In response to the
comments requesting that we revise the code descriptor to refer to a
crisis narrative and add the words ``that are documented in a form,''
we agree that a crisis narrative would be a typical component of these
services and that the safety plan would be documented in a form,
however, we do not believe that these items need to be listed in the
code descriptor. Additionally, we note that GSPI1 was a placeholder
code and the final code number is HCPCS code G0560 (Safety planning
interventions, each 20 minutes personally performed by the billing
practitioner, including assisting the patient in the identification of
the following personalized elements of a safety plan: recognizing
warning signs of an impending suicidal or substance use-related crisis;
employing internal coping strategies; utilizing social contacts and
social settings as a means of distraction from suicidal thoughts or
risky substance use; utilizing family members, significant others,
caregivers, and/or friends to help resolve the crisis; contacting
mental health or substance use disorder professionals or agencies; and
making the environment safe.
In summary, after consideration of public comments, we are
finalizing our proposal to create separate coding and payment for
safety planning interventions, with modifications. Specifically, we are
finalizing HCPCS code G0560 as a standalone code, rather than an add-on
code as proposed. We are also finalizing that HCPCS code G0560 can be
billed in units of 20 minutes. We are finalizing as proposed that HCPCS
code G0560 would need to be personally performed by the billing
practitioner for CY 2025, but we will continue to consider this issue
for future rulemaking.
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.\161\ 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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\161\ 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.\162\
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\162\ 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.'' \163\ In the SAFE VET
study \164\ 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
support treatment engagement.'' \165\ 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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\163\ 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.
\164\ https://pubmed.ncbi.nlm.nih.gov/29998307/.
\165\ 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 proposed in the CY 2025 PFS proposed rule 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 G-code is HCPCS code
G0544: 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
sought comment on whether we should consider finalizing a specified
duration that HCPCS code G0544 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 received public comments on these proposals. The following is a
summary of the comments we received and our responses.
We proposed 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 will be similar in nature and intensity. We noted that
under this proposal, HCPCS code G0544 could be billed regardless of
whether HCPCS code G0560 was also furnished and billed for the same
patient. We proposed that the billing practitioner will need to meet a
threshold of at least one real-time telephone interaction with the
patient in order to bill HCPCS code G0544, and that unsuccessful
attempts to reach the patient will not qualify as
[[Page 97922]]
a real-time telephone interaction. We welcomed comments on this
threshold to bill HCPCS code G0544, recognizing that while
practitioners may attempt to reach the patient, there may be times when
the patient cannot be reached. We also proposed that the billing
practitioner could not count time or effort more than once for the
purposes of billing this code and another service.
We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: Several commenters recommended that we unbundle these
calls, stating they should be billable per call, allowing up to four
calls per month. Commenters stated that unbundling would discourage
delaying initiation of these services due to concerns about having
enough time in a calendar month to complete a call, especially given
the challenges of reaching patients; would incentivize placing multiple
calls per month; provide flexibility; and generate data on the number
of calls completed, which could be used for future refinement of the
code. Commenters also noted that qualifying index visits for billing
FCI should include discharge from psychiatric inpatient units/
facilities. Several commenters also cited that evidence from the
Emergency Department Safety Assessment and Follow-Up Evaluation (ED-
SAFE) trial indicates that a longer follow-up period (6 months to a
year) significantly enhances the effectiveness of suicide prevention
efforts.
Response: We thank the commenters for their feedback. However, we
continue to believe that a monthly billing structure would be the most
efficient manner in which to bill these services and therefore, we are
finalizing HCPCS code G0544 as a monthly bundle, as proposed. Regarding
the comments about a longer follow-up period, we acknowledge the
evidence cited and are not finalizing a set duration that this could be
billed for; rather, we are finalizing that we will allow for this code
to be billed and paid for as long as the service is medically
reasonable and necessary.
Comment: A commenter suggested that instead of establishing G-
codes, CMS could propose extending the use of or revising the existing
CPT codes for transitional care management and/or discharge day
management services to help patients safely return to their home or
community from the ED or other settings.
Response: We appreciate these comments and may consider them for
future rulemaking. We are finalizing HCPCS code G0544 as proposed. We
also recognize that 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 would
consider using any newly available CPT coding to describe services
similar to those described here in future rulemaking.
Comment: A few commenters recommended that payment or partial
payment be made for earnest attempts to contact the individual, even if
the contact is unsuccessful, in order to recognize the effort and time
it takes for the provider to attempt to furnish critical follow up.
Response: We thank the commenters for this feedback. However, we
are finalizing as proposed that the billing practitioner will need to
meet a threshold of at least one real-time telephone interaction with
the patient in order to bill HCPCS code G0544, and that unsuccessful
attempts to reach the patient will not qualify as a real-time telephone
interaction.
Comment: A few commenters suggested that CMS should value HCPCS
code G0544 based on a crosswalk to CPT code 99490, Chronic Care
Management, first 20 minutes, which is assigned a work RVU of 1.00.
Response: The proposed work RVU for HCPCS code G0544 is 1.00, based
on a crosswalk to CPT code 99426 (Principal Care Management). Since CPT
code 99426 and 99490 are currently both assigned the same work RVU of
1.00, we are finalizing this valuation as proposed.
Comment: Several commenters suggested that HCPCS code G0544 should
be applicable to other settings where an individual is discharged for a
crisis encounter and some commenters suggested that CMS should allow
this service to be provided in conjunction with a discharge from a
hospital, inpatient behavioral health facility, and other inpatient
settings.
Response: We thank the commenters for this feedback. We wish to
clarify that HCPCS code G0544 can be billed by practitioners in any
instance in which the beneficiary has been discharged following a
crisis encounter, including discharge from psychiatric inpatient care,
or crisis stabilization.
Comment: Some commenters requested clarification regarding whether
auxiliary personnel could participate in furnishing the services
described by HCPCS code G0544 incident to the services of the billing
practitioner.
Response: We thank the commenters for this request. We wish to
clarify that the services described by HCPCS code G0544 can be provided
by auxiliary personnel incident to the services of the billing
practitioner in accordance with the requirements of Sec. 410.26.
Additionally, as we recognized 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 noted 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
recognized 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 G0544, we proposed to require the treating practitioner to obtain
verbal (or written) beneficiary consent in advance of furnishing the
services described by G0544, 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 noted 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.
We received public comments on this proposal. The following is a
summary of the comments we received and our responses.
Comment: One commenter stated that while they agree that consent
would be necessary for these services given the financial liability the
patient will incur, it may not be possible to obtain consent before
performing the services and therefore urged CMS to allow consent to be
obtained during the initial phone call. Some commenters suggested
[[Page 97923]]
eliminating cost sharing for this service, noting that who require
these services are already in an emotionally and mentally vulnerable
place and may be reluctant to interact with healthcare providers.
Response: We thank the commenters for this feedback. In response to
the comments, we agree that it may not be possible to obtain consent
prior to the first phone call, and therefore, we are finalizing to
allow consent to be obtained either prior to, or during the initial
phone call. Regarding the suggestion to eliminate cost sharing for this
service, we note that we do not have statutory authority to waive cost
sharing for these services.
Lastly, we note that GFCI1 was a placeholder code. The final code
number describing this service is HCPCS code G0544.
2. Digital Mental Health Treatment (DMHT)
We proposed 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 refined 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). In this
final 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,
approved, or granted De Novo authorization 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 noted first that the Diagnostic and Statistical Manual of Mental
Disorders-5 (DSM-5) does not refer to psychiatric disorders but to
mental disorders. In this section, following the DSM-5, we used the
term behavioral health conditions and mental disorders interchangeably
and to mean psychiatric disorders as referenced in FDA regulation, 21
CFR 882.5801. This includes substance use disorders. Second, we noted
that FDA guidance refers to computerized behavioral therapy by the
acronym CBT. We stated in the proposed rule that we aimed 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 noted that we recognized that
there are certain statutory limitations on payment for products under
the broader category of ``digital health interventions.'' We
acknowledged 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 recognized 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 noted 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
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. Further, 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
[[Page 97924]]
(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.
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 care 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
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.\166\ SAMHSA has adopted the
International Organization for Standardization's definition of DTx 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.'' \167\ 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 access to these services.\168\ 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. Specifically, we proposed in the CY 2025 PFS proposed
rule to pay billing practitioners for 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 if that device had been
cleared by FDA for use under 21 CFR 882.5801. Given that devices are
not ``cleared'' by FDA for use under 21 CFR 882.5801, we clarify here
that this proposed coding and payment policy would apply to DMHT
devices that have been cleared under section 510(k) of the Food, Drug,
and Cosmetics Act (FD&C Act) or granted De Novo authorization by FDA
and classified under 21 CFR 882.5801, as discussed below. 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 at this time
show evidence demonstrating improved behavioral health outcomes.\169\
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\166\ https://www.imdrf.org/sites/default/files/docs/imdrf/final/technical/imdrf-tech-131209-samd-key-definitions-140901.pdf.
\167\ https://store.samhsa.gov/product/advisory-digital-therapeutics-management-and-treatment-behavioral-health/pep23-06-00-001.
\168\ https://bhw.hrsa.gov/sites/default/files/bureau-health-workforce/data-research/behavioral-health-2013-2025.pdf.
\169\ https://store.samhsa.gov/product/advisory-digital-therapeutics-management-and-treatment-behavioral-health/pep23-06-00-001.
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We proposed to create three new HCPCS codes for DMHT devices
modeled on coding for RTM services. Effective beginning in CY 2025, we
proposed 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: G0552 (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. HCPCS code G0552 would be payable only if the
DMHT device has been cleared under section 510(k) of the FD&C Act or
granted De Novo authorization by FDA and classified under 21 CFR
882.5801 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 classified 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.'' HCPCS code G0552 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 sought comment about other parameters that we should consider
regarding the services described by HCPCS code G0552:
Whether payment should be made if the practitioner
furnishes a digital device that has not been classified by FDA for a
specific use under 21 CFR 882.5801 for mental health treatment, even if
the digital device has been classified by the FDA for another specific
use under 21 CFR 882.5801;
[[Page 97925]]
Whether payment should be made for DMHT devices cleared
under section 510(k) of the FD&C Act or granted De Novo authorization
by FDA and classified 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 previously, we
proposed contractor pricing for HCPCS code G0552. We sought comment
regarding what national pricing methodology we might consider,
including what potential crosswalks would be appropriate.
We also proposed to establish payment for two additional new HCPCS
codes. These codes are HCPCS code G0553 (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 HCPCS code
G0554 (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, HCPCS code
G0552 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. HCPCS codes G0553 and G0554 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 HCPCS code G0553 (first 20 minutes of monthly treatment
management services directly related to use of the DMHT device), we
proposed 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
HCPCS code G0554 (each additional 20 minutes of monthly treatment
management services directly related to DMHT device), we proposed 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 HCPCS codes
G0553 and G0554, 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 welcomed comments on the
proposed RVUs.
We received many public comments on these proposals. Most
commenters expressed general support for our proposed coding. Only
about a dozen expressed opposition or overall negative sentiment.
Several dozen commenters expressed directional support but recommended
significant refinements. The following is a summary of the comments we
received and our responses.
Comment: Many commenters recommended we broaden our inclusion
criteria for which devices would qualify for billing HCPCS code G0552.
Some commenters felt that any product that had been classified as
software as a medical device by the FDA under Section 201(h)(1) of the
FD&C Act should be payable under our policy. Others opined that any
remote therapeutic intervention based on medical devices as defined by
FDA should be payable under HCPCS code G0552. Others felt that any
digital therapeutic device for diagnosis or treatment of a behavioral
health condition should be payable under HCPCS code G0552, and that
clinicians may review the scientific literature around such devices and
find them helpful and appropriate parts of certain behavioral health
plans.
Other commenters recommended that we define ``mental health
condition'' to explicitly include neurological conditions including
dementia that are currently subject to treatment with effective FDA-
authorized digital behavioral or psychological interventions. Many
commenters advocated that we include medical and neurodevelopmental
disorders to adequately cover the range of disorders treated by FDA-
authorized products. Others recommended we clarify that all conditions
in the DSM-5 are included, including SUD. Others asked that we make
payment for evidenced-based psychotherapies for medical conditions that
are not generally considered a mental health condition as defined by
the DSM-5, for example, irritable bowel syndrome (IBS0, cancer care or
obesity treatment. (Whether any of these may be classified as a
``somatic symptom disorder'' in the DSM-5 would be a matter for
clinical judgement.)
Many supported payment for digital therapeutic devices specifically
when they are furnished incident to a professional health service or
ordered by a qualified health professional. Some commenters asked that
we clarify which health professionals may report HCPCS code G0552 and
asked whether auxiliary personnel such as peer support specialists and
community health workers can bill the new codes because education and
engagement are critical parts of successful use of digital mental
health services.
Others, in response to our question about payment for devices
classified by FDA under regulations besides 21 CFR 882.5801,
Computerized behavioral therapy device for psychiatric disorders,
offered that we should include devices for Gastrointestinal Conditions
(21 CFR 876.5960), Attention Deficit Hyperactivity Disorder (21 CFR
882.5803), and Sleep Disturbance for Psychiatric Conditions (21 CFR
882.5705). Others recommended payment for Biofeedback (21 CFR 882.5050)
devices.
Several commenters proposed that we adopt the definition provided
in the Access to Prescription Digital Therapeutics Act of 2023, S723/
HR1458: A product, device, internet application, or other technology
that is cleared or approved under section 510(k), 513(f)(2), or 515 of
the FD&C Act; has a cleared or approved indication for the prevention,
management or treatment of a medical disease, condition or disorder;
primarily uses software to achieve its intended result; and is a device
that is exempt from section 502(f)(1) of the FD&C Act under 21 CFR
801.109.
On the other hand, some commenters expressed concern that FDA
regulatory pathways are inadequate FD&C Act because many devices are
authorized without having submitted rigorous studies demonstrating
safety or effectiveness. Other commenters wanted to ensure that DMHT
devices are safe and beneficial for clinicians and patients. Several
commenters
[[Page 97926]]
recommended we define digital mental health treatment device
independent of FDA regulatory classification pathways. Some commenters
recommended that CMS create a registry of all eligible devices as a
condition of payment or adopt a model developed by the American
Psychiatric Association to evaluate their efficacy.
Other commenters supported our proposal's focus on digital
interventions for behavioral health (including mental health and
substance use disorders). Other commenters felt we should also include
devices that are granted De Novo classification under section 513(f)(2)
of the FD&C Act or granted Premarket Approval under section 515 of the
FD&C Act. Others felt that DMHT devices do not always provide better
health outcomes, and only high-quality, safe, and effective devices
should be used. Others supported payment for DMHT devices as long as
they are part of a physician-directed care plan. Another commenter
supported our limited proposal because they believed DMHT applications
are proliferating and their evidence base is minimal. Some referenced
various efforts underway to develop an evidence-based evaluation
framework for digital therapies. Another encouraged the continued
evaluation of these services to ensure their efficacy in patient care.
Another suggested CMS issue a broader RFI to gain stakeholder input on
a fair and transparent process for evaluating ``Algorithm Based Health
Services''. Another opined that CMS should identify opportunities and
encourage vendors and billing practitioners to join in efforts to
leverage interoperable DMHT data measure quality. Many commenters also
recommended that DMHT devices and their technologies ensure or
demonstrate data privacy and security. One commenter remarked about our
inconsistent language in the proposal using the phrase ``incident to or
integral to professional behavioral health services.''
Response: We appreciate all the comments and recommendations
offered for our consideration. Commenters expressed wide ranging views
about how broadly we should define DMHT devices for payment under HCPCS
code G0552. First, we acknowledge the inconsistent use of the term
``incident to or integral to professional behavioral health services.''
We note that ``integral to'' is language reflected in one of the
elements of the applicable regulation, 42 CFR 410.26(b)(2). We clarify
that we were referencing 42 CFR 410.26 in the language ``incident to or
integral to'' used in the proposed rule and that for clarity we are
using ``incident to'' by itself in this section regarding DMHT devices
furnished incident to professional behavioral health services used in
conjunction with ongoing behavioral health treatment under a behavioral
health treatment plan of care. Second, as stated above, we wish to
clarify that the definition of DMHT device as proposed would include
devices cleared under section 510(k) of the FD&C Act or granted De Novo
authorization by FDA. In both instances, however, the device would need
to be classified under 21 CFR 882.5801 to be payable under this policy.
We agree with commenters who expressed concern with ensuring that
DMHT devices are not only safe for patients but also beneficial for
patients. The technologies and platforms for digital therapeutics are
evolving rapidly. We are at a starting point of Medicare payment for
DMHT devices as supplies furnished incident to professional behavioral
health services used in conjunction with ongoing behavioral health care
treatment under a behavioral health treatment plan of care and
anticipate that this will be an iterative process. We are also
cognizant that some of the definitions for DMHT devices that commenters
proposed, or devices commenters recommended should be payable under
HCPCS code G0552, including most Class I devices (exempt from 510(k))
may not be aligned with similar terms used by other agencies and may
encompass devices not evaluated or authorized by the FDA. Commenters
have noted the work of the American Psychiatric Association, and the
Agency for Health Research and Quality (AHRQ), among others. Commenters
have suggested CMS leverage its convening power to bring interested
parties together to develop frameworks, quality measures, or DMHT
device registries. Recommendations for CMS to do so are beyond the
scope of the proposed policies in the CY 2025 PFS proposed rule. We do
not have the capacity as some commenters have suggested to undertake
evaluation of DMHT devices.
While partly in recognition of our inability to evaluate every DMHT
device, we proposed to define DMHT device under the proposed codes as
devices cleared under section 510(k) of the FD&C Act or granted De Novo
authorization by FDA and classified under 21 CFR 882.5801 in an effort
to ensure our payment policies for DMHT devices are aligned with
devices the FDA classified with special controls requiring clinical
data to validate the model of behavioral therapy as implemented by the
device. We appreciate commenters concerns for patient privacy and data
security. FDA's regulation of medical devices focuses on safety and
effectiveness. Although loss of confidential health information is
generally not considered to be a direct impact on safety and
effectiveness, under Section 524B of the FD&C Act, a person who submits
a 510(k), PMA, PDP, De Novo, or HDE for a device that meets the
definition of a cyber device is required to submit information to
ensure that cyber devices meet the cybersecurity requirements under
section 524(b) of the FD&C Act.\170\ FDA recommends that manufacturers
submit their cybersecurity management plans as part of their premarket
submissions so that FDA can assess whether the manufacturer has
sufficiently addressed how to maintain the safety and effectiveness of
the device after marketing authorization is achieved. Additionally,
please note that manufacturers may be obligated to protect the
confidentiality, integrity and availability of protected health
information (PHI) throughout the product lifecycle in accordance with
applicable federal and state laws, including the Health Insurance
Portability and Accountability of 1996 (HIPAA).
---------------------------------------------------------------------------
\170\ Cybersecurity in Medical Devices: Quality System
Considerations and Content of Premarket Submissions, Guidance for
Industry and Food and Drug Administration Staff, issued September
27, 2023. https://www.fda.gov/media/119933/download.
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We are finalizing payment under HCPCS code G0552 for DMHT devices
furnished incident to professional behavioral health services used in
conjunction with ongoing behavioral health treatment under a behavioral
health treatment plan of care. Specifically, we are finalizing that
DMHT devices under this payment policy must be cleared under section
510(k) of the FD&C Act or granted De Novo authorization by FDA and in
each case must be classified under 21 CFR 882.5801 for mental or
behavioral health treatment. While presently use cases for insomnia,
substance use disorder, depression and anxiety have been classified by
the FDA under 21 CFR 882.5801, future use cases are not necessarily
limited to these. Our objective in proposing that DMHT devices be
classified under 21 CFR 882.5801 as a condition of payment was to set
guardrails within our payment policy for patient safety and benefit. As
clarified above, devices granted De Novo authorization by FDA if
classified under 21 CFR 882.5801 would fall under the definition of
DHMT device. We proposed to limit payment to
[[Page 97927]]
devices classified under 21 CFR 882.5801 which are required to comply
with the Class II special controls set forth at 21 CFR 882.5801(b),
including clinical data to validate the model of behavioral therapy as
implemented by the device.
Furthermore, we are finalizing that a physician or other
practitioner who is authorized to diagnose, evaluate, and treat a
mental health disorder may prescribe or order a DMHT device as
permitted under the device's FDA clearance in accordance with State
prescriptive authority and may report HCPCS code G0552. We are
clarifying that auxiliary personnel meeting the requirements of 42 CFR
410.26(a)(1) may only provide part of the initial education and
onboarding described in HCPCS code G0552, and cannot report HCPCS code
G0552, as they do not have the statutory authority to serve as the
billing practitioner. Additionally, we are clarifying that we do not
define behavioral health services by HCPCS codes or by direct reference
to the DSM-5. In the CY 2023 PFS final rule we did not propose to do so
and did not do so when we finalized to allow behavioral health services
to be furnished under the general supervision of a physician or NPP
when these services or supplies are provided by auxiliary personnel
incident to the services of a physician or NPP (87 FR 69546). In
general, we understand a behavioral health service to be any service
furnished for the diagnosis, evaluation, or treatment of a mental
health disorder, including substance use disorders (SUD). However, we
continue to believe individual practitioners are in the best position
to determine whether particular services are behavioral health
services. As stated in the CY 2022 PFS final rule (86 FR 65061), SUD
services are considered mental health services for the purposes of the
expanded definition of ``interactive telecommunications system.''
Moreover, in the CY 2010 PFS final rule (74 FR 61787), we referenced
that the outpatient mental health treatment limitation, which was
phased out as of 2014, applied to outpatient treatment of a mental,
psychoneurotic, or personality disorders, identified under the
International Classification of Diseases (ICD) diagnosis code range
290-319.
Comment: Several commenters recommended we refine the code
descriptors of HCPCS codes G0552, G0553 and G0554. Some commenters
suggested we define the course of treatment to be 30 days and allow
HCPCS code G0552 to be billed in subsequent 30-day increments. For this
purpose, they recommended that the work RVU for initial education and
onboarding be removed from HCPCS code G0552 or that a second subsequent
month per course of treatment device code could be created. Other
commenters welcomed the inclusion of initial education and onboarding
in HCPCS code G0552. While commenters generally supported the two HCPCS
codes G0553 and G0554 for treatment management related to a patient's
therapeutic use of a DMHT device, several commenters recommended that
we acknowledge that many DMHT devices do not collect patient data. Many
commenters recommended that we distinguish the treatment management
codes from existing RTM codes by revising the descriptors for HCPCS
codes G0553 and G0554 to replace the words: ``reviewing data generated
from the DMHT device from'' with ``reviewing information related to the
use of the DMHT device, including.'' In particular, some commenters who
opposed our proposal thought that the RTM family of codes as revised
effective January 1, 2024, by the AMA CPT Editorial Panel would overlap
with HCPCS code G0552 and create confusion for practitioners.
Response: We thank commenters for their feedback about refining the
descriptors for our proposed HCPCS codes G0552, G0553 and G0554. We are
finalizing HCPCS code G0552 as proposed. We are finalizing HCPCS code
G0553 with these refinements: G0553 (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 information related to the use
of the DMHT device, including 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). We
are finalizing HCPCS code G0554 with the following refinements: (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
information related to the use of the DMHT device, including 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. (List separately in addition to
HCPCS code G0553)). We have noted that DMHT devices vary in the typical
course of treatment and acknowledge that persons with mental health and
behavioral health conditions may experience circumstances necessitating
that their practitioners extend the time. As commenters noted, limiting
HCPCS code G0552 to a monthly period would necessitate creating another
code to account for a course of treatment beyond a month. As to
commenters concerns for potential overlap, we believe that HCPCS code
G0552 is specific enough that practitioners could determine when to use
RTM coding instead of HCPCS code G0552. We are finalizing refinements
to HCPCS codes G0553 and G0554 to clarify that these codes are for
treatment management with a DMHT device which is intended as a
therapeutic intervention as opposed to RTM devices which, beginning
January 1, 2024, will describe devices that may have a digital
therapeutic intent as well as be intended to monitor response to a
therapeutic intervention not necessarily delivered by an RTM device.
HCPCS code G0552 does not describe a device intended to monitor
response to therapeutic intervention. We expect that practitioners will
report the more specific HCPCS code G0552 when the DMHT device meets
conditions of payment we are finalizing. We expect that practitioners
will report the more specific HCPCS codes G0553 and G0554 when
treatment management services are directly related to a DMHT device
described by HCPCS code G0552 meeting these conditions of payment.
HCPCS code G0552 would be payable only if:
The DMHT device has been cleared under section 510(k) of
the FD&C Act or granted De Novo authorization by FDA and classified
under 21 CFR 882.5801 as described above.
The billing practitioner is incurring the cost of
furnishing the DMHT device to the beneficiary.
Furnishing of the DMHT device is incident to the billing
practitioner's professional services in association with ongoing
behavioral health treatment under a plan of care by the billing
practitioner.
The billing practitioner diagnoses the patient with a
mental health condition and prescribes or orders the DMHT device.
HCPCS code G0552 shall 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. One commenter noted an example of a
[[Page 97928]]
DMHT device classified by the FDA under 21 CFR 882.5801, that is
prescribed by a practitioner, but the practitioner bears no cost for
the device. In that case the commenter is correct that payment is not
available to the practitioner. The benefit category for HCPCS code
G0552 requires that payment for the DMHT device as a supply incident to
a practitioner's professional services be a supply cost that the
practitioner has incurred. We are aware this may be a limitation with
respect to DMHT devices being payable under HCPCS code G0552.
Comment: In response to questions we raised in the proposed rule,
commenters were divided among those concerned principally by greater
access to treatment versus guarding against potential waste or misuse,
and those concerned principally by patient safety. Some commenters felt
that a practitioner and patient should determine whether to use a
device ``off-label'' and whether it would be appropriate to use more
than one device when the patient had more than one behavioral health
condition. While others felt the risks for using a device for a
different indication than for which it was authorized by FDA, or using
more than one device at a time could pose unknown risks and furthermore
that similar efficacy could not be inferred for these use cases. MedPAC
suggested we consider giving the Parts A/B Medicare Administrative
Contractors (MACs) the discretion to cover use of digital devices for
purposes other than what has been approved by the FDA, similar to MACs'
ability to cover non- cancer drugs for off-label indications.
Response: We agree with commenters who expressed concerns about
unknown risks and that similar efficacy could not be inferred for cases
using a device for a different indication than for which it was
authorized. We are finalizing that payment may only be made for DHMT
devices for mental health treatment in accordance with the use
indicated in their FDA classification under 21 CFR 882.5801.
Comment: Commenters generally supported payment for concurrent use
of different DMHT devices used in the treatment of different mental
health or behavioral health conditions. Some suggested heightened
documentation requirements for such cases.
Response: We agree that many individuals with mental health or
behavioral health conditions may have more than one co-occurring
condition. We are not finalizing any limits in this regard.
Comment: Some commenters noted that practitioners who bore the cost
of acquiring the device should not be liable for the cost of the device
when a patient discontinued treatment given that patients with mental
health conditions often go off treatment and return subsequently. Some
commenters felt reduced payment was appropriate in those circumstance
and suggested that Modifier-52 could be reported for reduced services.
Response: We agree with commenters who noted many individuals with
certain behavioral health conditions are at a higher risk of not
adhering to treatment or experiencing events that may necessitate
temporary pauses in treatment. For these reasons, we are not finalizing
a reduction in payment at this time for discontinued use of the
treatment before the full course of treatment has been completed.
Comment: Some commenters urged us to set a national price based on
invoices submitted to us or based on crosswalks to PE-only codes and
codes with work RVUs for the initial education and onboarding. Some
commenters recommended we adopt contractor pricing temporarily until we
and our contractors have gained enough experience to adopt national
pricing on product specific or product class specific codes. Some
commenters noted that one device code was impractical for the range of
devices they thought we intended and others recommended including that
product classes be defined by treatment length, mechanism of action and
hardware requirements. Most commenters supporting the proposal
expressed no opinion about the proposed pricing. Some commenters
recommended CM work with CMMI on developing a payment model. Finally,
MedPAC recommended payment for the device be included in larger payment
bundles.
Response: After consideration of public comments, we are finalizing
to contractor price HCPCS code G0552, as proposed. We are also
finalizing payment for HCPCS codes G0553 and G0554 as proposed. We note
that the invoices we received vary considerably. At this time, we do
not believe we can appropriately price all the DMHT devices for which
we propose to make payment. As we have noted, the technologies and DMHT
therapies are evolving rapidly. Given the dynamic nature of the
development of these devices and the variation in methods of action for
potential technology platforms, we do not have sufficient information
needed to establish national pricing for devices under HCPCS code G0552
at this time. However, we continue to welcome information on this and
may consider national pricing through future rulemaking.
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 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 section 1861(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
[[Page 97929]]
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
proposed 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 will 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 (G0546-G0551) or CPT code (99451, 99446, 99447,
99448, 99449), 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 G0551 or CPT code 99452 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 proposed
payment for six new G codes: G0546 (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), G0547 (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), G0548 (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), G0549 (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), G0550 (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
G0551 (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 welcomed
comments on this proposal.
We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: Commenters overwhelmingly supported interprofessional
consultations provided by a practitioner in a specialty whose covered
services are limited by statute to services for the diagnosis and
treatment of mental illness. We also received comments requesting that
instead of creating new HCPCS coding, we establish an exception to the
interprofessional consultation CPT codes. Commenters cited potential
confusion for having separate codes for the same service.
Response: In the CY 2019 PFS final rule (83 FR 59491), we
established a policy to limit billing of the CPT interprofessional
consultation codes to the types of practitioners who can independently
bill Medicare for E/M visits since the text of these codes specifies
that the practitioners involved in the consultation be physicians or
other qualified health care professionals. We continue to believe that
the CPT interprofessional consultation codes are most appropriate for
physicians or other qualified health care professionals, and HCPCS
G0546-G0551 are most appropriate for practitioners in a specialty whose
covered services are limited by statute to services for the diagnosis
and treatment of mental illness.
Comment: Commenters requested clarification on whether the
treating/requesting practitioner and the consulting provider must be in
the same organization to bill interprofessional consultation codes.
Response: No, the treating/requesting practitioner and the
consulting provider do not have to be in the same organization to
furnish interprofessional consultation services.
After consideration of public comments, we are finalizing HCPCS
G0546-G0551 codes as proposed.
Additionally, since these codes describe services that are
furnished by the treating/requesting practitioner and the consultant
practitioner without the
[[Page 97930]]
involvement of the patient, we proposed 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 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 welcomed comments on this proposal.
We received public comments on this proposal. The following is a
summary of the comments we received and our responses.
Comment: Commenters generally supported obtaining patient consent
for these services, as they are usually furnished outside the presence
of the patient. Some commenters requested that the requirement for
consent not apply when the patient already has a relationship with the
billing practitioner.
Response: We continue to believe that consent must be obtained for
these services since they are furnished outside the presence of the
patient. In addition, we continue to believe that it is important that
patients are informed that they may be responsible for the cost sharing
of two services.
After consideration of public comments, we are finalizing the
consent requirements for HCPCS codes G0546-G0551 as proposed.
c. Valuation
We proposed 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 proposed a work RVU
of 0.35 for G0546 based on a crosswalk to CPT code 99446, a work RVU of
0.70 for G0547 based on a crosswalk to CPT code 99447, a work RVU of
1.05 for G0548 based on a crosswalk to CPT code 99448), a work RVU of
1.40 for G0549 based on a crosswalk to CPT code 99449, a work RVU of
0.70 for G0550 based on a crosswalk to CPT code 99451, and a work RVU
of 0.70 for G0551 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 G0546-G0551, we did not
propose any direct PE inputs for these codes. We welcomed comments on
this proposal.
Comment: Commenters were supportive of our proposed valuations for
HCPCS codes G0546-G0551.
Response: We thank commenters for their support.
After consideration of public comments, we are finalizing HCPCS
codes G0546-G0551 as proposed.
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 Intensive Outpatient Program (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
noted 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 sought 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 were 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?
We received public comments on these questions. The following is a
summary of the comments we received and our responses.
Comment: Several commenters stated they believe that freestanding
SUD facilities and other entities that furnish IOP services serve an
important function in their communities and thus should have a
sustainable payment structure because of their vital role in treatment
engagement. Several commenters urged CMS to enable payment for
freestanding facilities that furnish IOP services, as well as for other
levels of care along the continuum of SUD treatment and recovery
(including Level 0.5 early intervention and screening, Level 1
outpatient treatment, Level 2.5 high-intensity outpatient treatment
(previously partial hospitalization (PHP)), and Level 2.7 medically
managed intensive outpatient treatment) to facilitate greater access to
and continuity of SUD care. Absent statutory changes, the commenters
encouraged CMS to adopt an ``incident to'' billing model for
freestanding SUD treatment facilities for all of these levels of care,
so long as (1) the reimbursement rate is no lower than the hospital
outpatient department rate, (2) an add-on code is developed to
appropriately compensate the billing practitioner--especially if they
are external to the facility--in a way that does not dilute the rate
for the freestanding SUD treatment facility; and (3) the billing
practitioner is able to perform their duties via telemedicine so as not
to delay or deter access to care where appropriate. One commenter from
a provider of SUD services noted that according to their internal data,
they had to turn away approximately 3,000 Medicare beneficiaries who
called seeking services because they are not an approved setting for
Medicare services and urged CMS to expand the Medicare provider type
definition to include non-hospital based state licensed freestanding or
standalone SUD treatment centers to ensure that participation under
Medicare does not
[[Page 97931]]
exclude high-quality facilities that are not classified as an OTP,
HOPD, CMHS, FQHC, or RHC. One commenter stated that CMS should only
expand IOP services to other types of entities if they follow the same
rules that apply for the approved entities now in place, including
regulatory requirements from State licensing and accreditation bodies
that create a layer of accountability. This commenter supported having
a physician (or equivalent) guiding and directing all admissions,
treatment planning, and discharges for IOP regardless of the type of
organization providing the services. AABH also strongly advocates for
the use of a multi-disciplinary team to provide the level of care that
should be provided and billed as an IOP.
Response: We thank the commenters for the detailed comments
received on these topics and note that we may consider this input for
potential policy proposals through future rulemaking.
Comment: Some commenters noted that CCBHCs are able to provide
services that typically comprise an IOP program, noting that based on
the community needs assessment, this may look different across the
country as CCBHCs can respond with the level of intensity of care that
is responsive and personalized to an individual's need in the
community, and ultimately the care provided could rise to a level of
care similar to what an IOP program might consist of at a community
mental health center (CMHC). However, the commenter urged CMS' caution
in pursuing this benefit at CCBHCs, stating that CMHCs appear to face
challenges in providing the IOP benefit under Medicare because the
Medicare CMHC Conditions of Participation (CoPs) pose challenges and
significant administrative burden for provider organizations.
Response: We thank the commenters for the detailed comments
received on these topics and note that we may consider this input for
potential policy proposals through future rulemaking.
Additionally, we sought 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 were 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?
We received public comments on these questions. The following is a
summary of the comments we received and our responses.
Comment: Commenters stated that innovative approaches such as
crisis stabilization units have helped communities improve coordination
of emergency psychiatric care, and they can serve as models for other
communities to implement and build upon to help alleviate the overall
load on the mental health care system and emergency psychiatric
boarding. Another commenter stated that payment for mental health and
SUD services in these settings would greatly expand access to care in
the midst of the ongoing overdose epidemic and mental health crisis,
which has been exacerbated by workforce shortages. This commenter noted
that especially with the increased access to crisis services through
the 988 crisis line and the new mobile crisis psychotherapy code,
expanding access to crisis receiving and crisis stabilization services
at these settings would ensure that Medicare beneficiaries have access
to the full continuum of crisis services and supports they need. One
commenter stated that the definition of crisis stabilization, as well
as ``sobering care,'' can vary from state to state, and noted that
variations can include: acceptance of involuntary admissions, referring
parties (law enforcement, EMS, walk-in, etc.), length of stay,
environment, staffing levels and qualifications, etc.
Response: We thank the commenters for the detailed comments
received on these topics and note that we may consider this input for
potential policy proposals through future rulemaking.
Additionally, as a separate example, we have 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 were 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?
We received public comments on these questions. The following is a
summary of the comments we received and our responses.
Comment: One commenter suggested that CMS create a payment
structure in which urgent care centers are differentially compensated.
In response to our question about the existing place of service codes,
they stated that the current place of service (POS) definitions are
inadequately
[[Page 97932]]
differentiated, especially if CMS wishes to encourage proliferation of
the type of urgent care centers that can provide suitable alternatives
to EDs, noting that POS 11 generally refers to physician offices that
provide diagnostic and therapeutic care in an office setting, by
appointment, typically during regular business hours; POS 17 generally
refers to clinics that are attached to retail operations, such as
pharmacies, grocery stores or big box stores, and provide low-acuity
primary and preventive health care, such as vaccinations; and POS 20
refers to UCCs but does not adequately differentiate between those that
offer services more akin to the typical general practitioner's office
and those that offer enhanced diagnostic and therapeutic services and
extended hours. They suggested that the creation of a new POS code
describing ``enhanced'' urgent care centers that offer specific
diagnostic and therapeutic services and that operate outside typical
business hours could fill this need. In response to our question about
the existing code set and valuation, they stated that Medicare's fee-
for-service payment systems do not recognize and adequately value
services furnished in UCCs and stated that while there is some overlap
in the types of professional services furnished in UCCs and physician
offices, UCCs that operate for extended hours and that have enhanced
diagnostic and therapeutic capabilities incur additional costs to
provide these services.
One commenter stated they appreciate the important role that non-
emergency facilities, such as urgent care centers, can play treating
patients, but emphasized that it is essential to preserve the
fundamental right for patients to seek emergency care when they think
they are experiencing a medical emergency. They encouraged CMS to
consider how best to educate beneficiaries about when they should seek
emergency treatment, their right to do so, and when another setting
such as an urgent care center may be appropriate to address their
health care needs. The commenter stated they believe that physician-led
care teams offer the highest quality of care, and every urgent care
should seek to have an emergency physician on staff and that in the
setting of physician-led teams, urgent care should be capable of caring
for the full range of non-life-threatening conditions. Another
commenter noted that many urgent care centers and retail clinics do not
accept public insurance (i.e., Medicare, Medicaid, CHIP, Tricare) due
to low reimbursement rates, stating that this disproportionately
impacts the ability for underserved patient populations to access non-
ED services for acute, unscheduled care. The commenter stated that
improving Medicare and Medicaid reimbursement for urgent care services
would advance equity and access for acute care amongst this patient
population.
Response: We thank the commenters for the detailed comments
received on these topics and note that we may consider this input for
potential policy proposals through future rulemaking.
Lastly, we sought comment regarding Certified Community Behavioral
Health Clinics (CCBHCs). Specifically, we were 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?