[Federal Register Volume 88, Number 220 (Thursday, November 16, 2023)]
[Rules and Regulations]
[Pages 78818-80047]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-24184]
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Vol. 88
Thursday,
No. 220
November 16, 2023
Part II
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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42 CFR Parts 405, 410, 411, et al.
Medicare and Medicaid Programs; CY 2024 Payment Policies Under the
Physician Fee Schedule and Other Changes to Part B Payment and Coverage
Policies; Medicare Shared Savings Program Requirements; Medicare
Advantage; Medicare and Medicaid Provider and Supplier Enrollment
Policies; and Basic Health Program; Final Rule
Federal Register / Vol. 88, No. 220 / Thursday, November 16, 2023 /
Rules and Regulations
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 405, 410, 411, 414, 415, 418, 422, 423, 424, 425, 455,
489, 491, 495, 498, and 600
[CMS-1784-F]
RIN 0938-AV07
Medicare and Medicaid Programs; CY 2024 Payment Policies Under
the Physician Fee Schedule and Other Changes to Part B Payment and
Coverage Policies; Medicare Shared Savings Program Requirements;
Medicare Advantage; Medicare and Medicaid Provider and Supplier
Enrollment Policies; and Basic Health Program
AGENCY: Centers for Medicare & Medicaid Services (CMS), Health and
Human Services (HHS).
ACTION: Final rule.
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SUMMARY: This major 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;
payment for dental services inextricably linked to specific covered
medical services; Medicare Shared Savings Program requirements; updates
to the Quality Payment Program; Medicare coverage of opioid use
disorder services furnished by opioid treatment programs; updates to
certain Medicare and Medicaid provider and supplier enrollment
policies, electronic prescribing for controlled substances for a
covered Part D drug under a prescription drug plan or an MA-PD plan
under the Substance Use-Disorder Prevention that Promotes Opioid
Recovery and Treatment for Patients and Communities Act (SUPPORT Act);
updates to the Ambulance Fee Schedule regulations and the Medicare
Ground Ambulance Data Collection System; codification of the Inflation
Reduction Act and Consolidated Appropriations Act, 2023 provisions;
expansion of the diabetes screening and diabetes definitions; pulmonary
rehabilitation, cardiac rehabilitation and intensive cardiac
rehabilitation expansion of supervising practitioners; appropriate use
criteria for advanced diagnostic imaging; early release of Medicare
Advantage risk adjustment data; a social determinants of health risk
assessment in the annual wellness visit and Basic Health Program.
DATES: These regulations are effective on January 1, 2024.
FOR FURTHER INFORMATION CONTACT:
[email protected], for any issues not
identified below. Please indicate the specific issue in the subject
line of the email.
[email protected], for the following issues:
practice expense, work RVUs, conversion factor, and PFS specialty-
specific impacts; the comment solicitation on strategies for updates to
practice expense data collection and methodology, caregiver training
services, community health integration services, social determinants of
health risk assessment, and principal illness navigation services;
potentially misvalued services under the PFS, direct supervision using
two-way audio/video communication technology, telehealth, and other
services involving communications technology; teaching physician
services, advancing access to behavioral health services, PFS payment
for evaluation and management services, geographic practice cost
indices (GPCIs), payment for skin substitutes, supervision of
outpatient therapy services, KX modifier thresholds, diabetes self-
management training (DSMT) services, and DSMT telehealth services, and
dental services inextricably linked to specific covered services.
Laura Ashbaugh, (410) 786-1113, and Erick Carrera, (410) 786-8949,
Zehra Hussain, (214) 767-4463, or
[email protected], for issues related to dental
services inextricably linked to specific covered medical services.
Laura Kennedy, (410) 786-3377, Adam Brooks, (202) 205-0671, and
Rachel Radzyner, (410) 786-8215, for issues related to Drugs and
Biological Products Paid Under Medicare Part B.
[email protected], for issues related to
complex drug administration.
Laura Ashbaugh, (410) 786-1113, and Ariana Pitcher, (667) 290-8840,
or [email protected] for issues related to Clinical Laboratory
Fee Schedule.
Lisa Parker, (410) 786-4949, or [email protected], for issues
related to FQHC payments.
Michele Franklin, (410) 786-9226, or [email protected], for issues
related to RHC payments.
Kianna Banks, (410) 786-3498 and Cara Meyer, (667) 290-9856, for
issues related to RHCs and FQHCs definitions of staff and Conditions
for Certification or Coverage.
Sarah Fulton, (410) 786-2749, for issues related to pulmonary
rehabilitation, cardiac rehabilitation and intensive cardiac
rehabilitation expansion of supervising practitioners.
Lindsey Baldwin, (410) 786-1694, Ariana Pitcher, (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 Elizabeth November, (410) 786-4518,
or [email protected], for issues related to Shared
Savings Program beneficiary assignment and benchmarking methodology.
Lucy Bertocci, (410) 786-3776, or [email protected],
for issues related to Shared Savings Program advance investment
payments, and eligibility requirements.
Rachel Radzyner, (410) 786-8215, and Michelle Cruse, (443) 478-
6390, for issues related to preventive vaccine administration services.
Mollie Howerton, (410) 786-5395, for issues related to Medicare
Diabetes Prevention Program.
Sarah Fulton, (410) 786-2749, for issues related to appropriate use
criteria for advanced diagnostic imaging.
Frank Whelan, (410) 786-1302, for issues related to Medicare and
Medicaid provider and supplier enrollment regulation updates.
Daniel Feller, (410) 786-6913 for issues related to expanding
diabetes screening and definitions.
Daniel Feller, (410) 786-6913 for issues related to a social
determinants of health risk assessment in the annual wellness visit.
Mei Zhang, (410) 786-7837, and Kimberly Go, (410) 786-4560, for
issues related to requirement for electronic prescribing for controlled
substances for a covered Part D drug under a prescription drug plan or
an MA-PD plan (section 2003 of the SUPPORT Act).
Amy Gruber, (410) 786-1542, or [email protected],
for issues related to the Ambulance Fee Schedule (AFS) and the Medicare
Ground Ambulance Data Collection System.
Mary Rossi-Coajou, (410) 786-6051, for issues related to hospice
Conditions of Participation.
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Cameron Ingram, (410) 409-8023 for issues related to
Histopathology, Cytology, and Clinical Cytogenetics Regulations under
CLIA of 1988.
Meg Barry, (410) 786-1536, for issues related to the Basic Health
Program (BHP) provisions.
Renee O'Neill, (410) 786-8821, or Sophia Sugumar, (410) 786-1648,
for inquiries related to Merit-based Incentive Payment System (MIPS)
track of the Quality Payment Program.
Richard Jensen, (410) 786-6126, 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
2024 PFS final rule, refer to item CMS-1784-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 major final rule revises payment polices under the Medicare
PFS and makes other policy changes, including to the implementation of
certain provisions of the Consolidated Appropriations Act, 2023 (Pub.
L. 117-328, September 29, 2022), Inflation Reduction Act of 2022 (IRA)
(Pub. L. 117-169, August 16, 2022), Consolidated Appropriations Act,
2022 (Pub. L. 117-103, March 15, 2022), Consolidated Appropriations
Act, 2021 (CAA, 2021) (Pub. L. 116-260, December 27, 2020), Bipartisan
Budget Act of 2018 (BBA of 2018) (Pub. L. 115-123, February 9, 2018)
and the Substance Use-Disorder Prevention that Promotes Opioid Recovery
and Treatment for Patients and Communities Act (SUPPORT Act) (Pub. L.
115-271, October 24, 2018), related to Medicare Part B payment. In
addition, this major final rule includes provisions regarding other
Medicare payment policies described in sections III. and IV.
This rulemaking updates the Rural Health Clinic (RHC) and Federally
Qualified Health Clinic (FQHC) Conditions for Certification and
Conditions for Coverage (CfCs), respectively, to implement the
provisions of the Consolidated Appropriations Act (CAA), 2023 (Pub. L.
117-328, December 29, 2022), now allowing payment under Medicare Part B
for services furnished by a Marriage and Family Therapist (MFT) or
Mental Health Counselor (MHC).
This rulemaking also updates the Hospice Conditions of
Participation (CoPs) to implement division FF, section 4121 of the CAA
2023 regarding the addition of marriage and family therapists (MFTs) or
mental health counselors (MHCs) as part of the hospice
interdisciplinary team and make changes to the hospice personnel
requirements.
This rulemaking also seeks to further advance Medicare's overall
value-based care strategy of growth, alignment, and equity through the
Medicare Shared Savings Program (Shared Savings Program) and the
Quality Payment Program (QPP). The structure of the programs enables us
to develop a set of tools for measuring and encouraging improvements in
care, which may support a shift to clinician payment over time into
Advanced Alternative Payment Models (APMs) and accountable care
arrangements which reduce care fragmentation and unnecessary costs for
patients and the health system.
This rulemaking also updates the public reporting requirements of
procedure volume data (Part B non-institutional claims) on clinician
profile pages of the Compare Tool to include Medicare Advantage (MA)
encounter data. This enables us to use and analyze MA encounter data as
part of the aggregated information disclosed through the Care Compare
website, more broadly fulfilling the public reporting requirements of
section 104 of the MACRA and section 10331 of the ACA and providing
beneficiaries with useful and appropriate information when selecting a
provider. This rulemaking also amends Sec. 422.310(f)(3) to permit the
release of the MA encounter data on the timeframe(s) used for
disclosure and release of the data on the Care Compare website.
This rulemaking also updates the Ambulance Fee Schedule regulations
to implement division FF, section 4103 of the CAA 2023 regarding the
ground ambulance extenders provisions and also provides further changes
and clarifications to the Medicare Ground Ambulance Data Collection
System.
This rulemaking also updates Medicare and Medicaid provider and
supplier enrollment regulations.
B. Summary of the Major Provisions
The statute requires us to establish payments under the PFS, based
on national uniform relative value units (RVUs) that account for the
relative resources used in furnishing a service. The statute requires
that RVUs be established for three categories of resources: work,
practice expense (PE), and malpractice (MP) expense. In addition, the
statute requires that each year we establish, by regulation, the
payment amounts for physicians' services paid under the PFS, including
geographic adjustments to reflect the variations in the costs of
furnishing services in different geographic areas.
The statute requires us to establish payments under the PFS, based
on national uniform relative value units (RVUs) that account for the
relative resources used in furnishing a service. The statute requires
that RVUs be established for three categories of resources: work,
practice expense (PE), and malpractice (MP) expense. In addition, the
statute requires that we establish each year by regulation the payment
amounts for physicians' services paid under the PFS, including
geographic adjustments to reflect the variations in the costs of
furnishing services in different geographic areas.
In this major final rule, we are establishing RVUs for CY 2024 for
the PFS to ensure that our payment systems are updated to reflect
changes in medical practice and the relative value of services, as well
as changes in the statute. This 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
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Social Security Act (the Act) (section II.D.)
Valuation of Specific Codes (section II.E.)
Evaluation and Management (E/M) Visits (section II.F.)
Geographic Practice Cost Indices (GPCI) (section II.G.)
Payment for Skin Substitutes (section II.H.)
Supervision of Outpatient Therapy Services, KX Modifier
Thresholds, Diabetes Self-Management Training (DSMT) Services by
Registered Dietitians and Nutrition Professional, and DSMT Telehealth
Services (section II.I.)
Advancing Access to Behavioral Health Services (section II.J.)
Policies on Medicare Parts A and B Payment for Dental Services
Inextricably Linked to Specific Covered Services (section II.K.)
Drugs and Biological Products Paid Under Medicare Part B
(section III.A.)
Rural Health Clinics (RHCs) and Federally Qualified Health
Centers (FQHCs) (section III.B.)
Rural Health Clinics (RHCs) and Federally Qualified Health
Centers (FQHCs) Conditions for Certification or Coverage (CfCs)
(section III.C.)
Clinical Laboratory Fee Schedule: Revised Data Reporting
Period and Phase-in of Payment Reductions (section III.D.)
Pulmonary Rehabilitation, Cardiac Rehabilitation and Intensive
Cardiac Rehabilitation Expansion of Supervising Practitioners (section
III.E.)
Modifications Related to Medicare Coverage for Opioid Use
Disorder (OUD) Treatment Services Furnished by Opioid Treatment
Programs (OTPs) (section III.F.)
Medicare Shared Savings Program (section III.G.)
Medicare Part B Payment for Preventive Vaccine Administration
Services (section III.H.)
Medicare Diabetes Prevention Program Expanded Model (section
III.I.)
Appropriate Use Criteria for Advanced Diagnostic Imaging
(section III.J.)
Medicare and Medicaid Provider and Supplier Enrollment
(section III.K.)
Expand Diabetes Screening and Diabetes Definitions (section
III.L.)
Requirement for Electronic Prescribing for Controlled
Substances for a Covered Part D Drug under a Prescription Drug Plan or
an MA-PD Plan (section 2003 of the SUPPORT Act) (section III.M.)
Changes to the Regulations Associated with the Ambulance Fee
Schedule and the Medicare Ground Ambulance Data Collection System
(GADCS) (section III.N.)
Hospice: Changes to the Hospice Conditions of Participation
(section III.O.)
RFI: Histopathology, Cytology, and Clinical Cytogenetics
Regulations under the Clinical Laboratory Improvement Amendments (CLIA)
of 1988 (section III.P.)
Changes to the Basic Health Program Regulations (section
III.Q.)
Updates to the Definitions of Certified Electronic Health
Record Technology (section III.R.)
A Social Determinants of Health Risk Assessment in the Annual
Wellness Visit (section III.S.)
Updates to the Quality Payment Program (section IV.)
Collection of Information Requirements (section V.)
Response to Comments (section VI.)
Regulatory Impact Analysis (section VII.)
C. Summary of Costs and Benefits
We have determined that this final rule is economically
significant. For a detailed discussion of the economic impacts, see
section VII., 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 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 refer readers to the CY 2010 Physician Fee Schedule (PFS)
final rule with comment period (74 FR 61743 through 61748) for a more
detailed explanation of the PE methodology.
2. Practice Expense Methodology
a. Direct Practice Expense
We determine the direct PE for a specific service by adding the
costs of the direct resources (that is, the clinical staff, medical
supplies, and medical equipment) typically involved with furnishing
that service. The costs of the resources are calculated using the
refined direct PE inputs assigned to each CPT code in our PE database,
which are generally based on our review of recommendations received
from the Relative Value Scale Update Committee (RUC) and those provided
in response to public comment periods. For a detailed explanation of
the direct PE methodology, including examples, we refer readers to the
5-year review of work RVUs under the PFS and proposed changes to the PE
methodology in the CY 2007 PFS proposed rule (71 FR 37242) and the CY
2007 PFS final rule with comment period (71 FR 69629).
b. Indirect Practice Expense per Hour Data
We use survey data on indirect PEs incurred per hour worked, in
developing the indirect portion of the PE RVUs. Prior to CY 2010, we
primarily used the PE/HR by specialty that was obtained from the AMA's
Socioeconomic Monitoring System (SMS). The AMA administered a new
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survey in CY 2007 and CY 2008, the Physician Practice Information
Survey (PPIS). The PPIS is a multispecialty, nationally representative,
PE survey of both physicians and NPPs paid under the PFS using a survey
instrument and methods highly consistent with those used for the SMS
and the supplemental surveys. The PPIS gathered information from 3,656
respondents across 51 physician specialty and health care professional
groups. We believe the PPIS is the most comprehensive source of PE
survey information available. We used the PPIS data to update the PE/HR
data for the CY 2010 PFS for almost all of the Medicare recognized
specialties that participated in the survey.
When we began using the PPIS data in CY 2010, we did not change the
PE RVU methodology itself or the manner in which the PE/HR data are
used in that methodology. We only updated the PE/HR data based on the
new survey. Furthermore, as we explained in the CY 2010 PFS final rule
with comment period (74 FR 61751), because of the magnitude of payment
reductions for some specialties resulting from the use of the PPIS
data, we transitioned its use over a 4-year period from the previous PE
RVUs to the PE RVUs developed using the new PPIS data. As provided in
the CY 2010 PFS final rule with comment period (74 FR 61751), the
transition to the PPIS data was complete for CY 2013. Therefore, PE
RVUs from CY 2013 forward are developed based entirely on the PPIS
data, except as noted in this section.
Section 1848(c)(2)(H)(i) of the Act requires us to use the medical
oncology supplemental survey data submitted in 2003 for oncology drug
administration services. Therefore, the PE/HR for medical oncology,
hematology, and hematology/oncology reflects the continued use of these
supplemental survey data.
Supplemental survey data on independent labs from the College of
American Pathologists were implemented for payments beginning in CY
2005. Supplemental survey data from the National Coalition of Quality
Diagnostic Imaging Services (NCQDIS), representing independent
diagnostic testing facilities (IDTFs), were blended with supplementary
survey data from the American College of Radiology (ACR) and
implemented for payments beginning in CY 2007. Neither IDTFs, nor
independent labs, participated in the PPIS. Therefore, we continue to
use the PE/HR that was developed from their supplemental survey data.
Consistent with our past practice, the previous indirect PE/HR
values from the supplemental surveys for these specialties were updated
to CY 2006 using the Medicare Economic Index (MEI) to put them on a
comparable basis with the PPIS data.
We also do not use the PPIS data for reproductive endocrinology and
spine surgery since these specialties currently are not separately
recognized by Medicare, nor do we have a method to blend the PPIS data
with Medicare recognized specialty data.
Previously, we established PE/HR values for various specialties
without SMS or supplemental survey data by 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 2024 PFS final rule PE/HR'' on the
CMS website under downloads for the CY 2024 PFS final rule athttp://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
c. Allocation of PE to Services
To establish PE RVUs for specific services, it is necessary to
establish the direct and indirect PE associated with each service.
(1) Direct Costs
The relative relationship between the direct cost portions of the
PE RVUs for any two services is determined by the relative relationship
between the sum of the direct cost resources (that is, the clinical
staff, medical supplies, and medical equipment) typically involved with
furnishing each of the services. The costs of these resources are
calculated from the refined direct PE inputs in our PE database. For
example, if one service has a direct cost sum of $400 from our PE
database and another service has a direct cost sum of $200, the direct
portion of the PE RVUs of the first service would be twice as much as
the direct portion of the PE RVUs for the second service.
(2) Indirect Costs
We allocate the indirect costs at the code level based on the
direct costs specifically associated with a code and the greater of
either the clinical labor costs or the work RVUs. We also incorporate
the survey data described earlier in the PE/HR discussion. The general
approach to developing the indirect portion of the PE RVUs is as
follows:
For a given service, we use the direct portion of the PE
RVUs calculated as previously described and the average percentage that
direct costs represent of total costs (based on survey data) across the
specialties that furnish the service to determine an initial indirect
allocator. That is, the initial indirect allocator is calculated so
that the direct costs equal the average percentage of direct costs of
those specialties furnishing the service. For example, if the direct
portion of the PE RVUs for a given service is 2.00 and direct costs, on
average, represent 25 percent of total costs for the specialties that
furnish the service, the initial indirect allocator would be calculated
so that it equals 75 percent of the total PE RVUs. Thus, in this
example, the initial indirect allocator would equal 6.00, resulting in
a total PE RVU of 8.00 (2.00 is 25 percent of 8.00 and 6.00 is 75
percent of 8.00).
Next, we add the greater of the work RVUs or clinical
labor portion of the direct portion of the PE RVUs to this initial
indirect allocator. In our example, if this service had a work RVU of
4.00 and the clinical labor portion of the direct PE RVU was 1.50, we
would add 4.00 (since the 4.00 work RVUs are greater than the 1.50
clinical labor portion) to the initial indirect allocator of 6.00 to
get an indirect allocator of 10.00. In the absence of any further use
of the survey data, the relative relationship between the indirect cost
portions of the PE RVUs for any two services would be determined by the
relative relationship between these indirect cost allocators. For
example, if one service had an indirect cost allocator of 10.00 and
another service had an indirect cost allocator of 5.00, the indirect
portion of the PE RVUs of the first service would be twice as great as
the indirect portion of the PE RVUs for the second service.
Then, we incorporate the specialty specific indirect PE/HR
data into the calculation. In our example, if, based on the survey
data, the average indirect cost of the specialties furnishing the first
service with an allocator of 10.00 was half of the average indirect
cost of the specialties furnishing the second service with an indirect
allocator of 5.00, the indirect portion of the PE RVUs of the first
service would be equal to that of the second service.
(3) Facility and Nonfacility Costs
For procedures that can be furnished in a physician's office, as
well as in a facility setting, where Medicare makes a separate payment
to the facility for its costs in furnishing a service, we establish two
PE RVUs: facility and nonfacility. The methodology for
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calculating PE RVUs is the same for both the facility and nonfacility
RVUs but is applied independently to yield two separate PE RVUs. In
calculating the PE RVUs for services furnished in a facility, we do not
include resources that would generally not be provided by physicians
when furnishing the service. For this reason, the facility PE RVUs are
generally lower than the nonfacility PE RVUs.
(4) Services With Technical Components and Professional Components
Diagnostic services are generally comprised of two components: a
professional component (PC); and a technical component (TC). The PC and
TC may be furnished independently or by different providers, or they
may be furnished together as a global service. When services have
separately billable PC and TC components, the payment for the global
service equals the sum of the payment for the TC and PC. To achieve
this, we use a weighted average of the ratio of indirect to direct
costs across all the specialties that furnish the global service, TCs,
and PCs; that is, we apply the same weighted average indirect
percentage factor to allocate indirect expenses to the global service,
PCs, and TCs for a service. (The direct PE RVUs for the TC and PC sum
to the global.)
(5) PE RVU Methodology
For a more detailed description of the PE RVU methodology, we
direct readers to the CY 2010 PFS final rule with comment period (74 FR
61745 through 61746). We also direct readers to the file titled
``Calculation of PE RVUs under Methodology for Selected Codes'' which
is available on our website under downloads for the CY 2024 PFS final
rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. This file
contains a table that illustrates the calculation of PE RVUs as
described in this final rule for individual codes.
(a) Setup File
First, we create a setup file for the PE methodology. The setup
file contains the direct cost inputs, the utilization for each
procedure code at the specialty and facility/nonfacility place of
service level, and the specialty specific PE/HR data calculated from
the surveys.
(b) Calculate the Direct Cost PE RVUs
Sum the costs of each direct input.
Step 1: Sum the direct costs of the inputs for each service.
Step 2: Calculate the aggregate pool of direct PE costs for the
current year. We set the aggregate pool of PE costs equal to the
product of the ratio of the current aggregate PE RVUs to current
aggregate work RVUs and the projected aggregate work RVUs.
Step 3: Calculate the aggregate pool of direct PE costs for use in
ratesetting. This is the product of the aggregate direct costs for all
services from Step 1 and the utilization data for that service.
Step 4: Using the results of Step 2 and Step 3, use the CF to
calculate a direct PE scaling adjustment to ensure that the aggregate
pool of direct PE costs calculated in Step 3 does not vary from the
aggregate pool of direct PE costs for the current year. Apply the
scaling adjustment to the direct costs for each service (as calculated
in Step 1).
Step 5: Convert the results of Step 4 to an RVU scale for each
service. To do this, divide the results of Step 4 by the CF. Note that
the actual value of the CF used in this calculation does not influence
the final direct cost PE RVUs as long as the same CF is used in Step 4
and Step 5. Different CFs would result in different direct PE scaling
adjustments, but this has no effect on the final direct cost PE RVUs
since changes in the CFs and changes in the associated direct scaling
adjustments offset one another.
(c) Create the Indirect Cost PE RVUs
Create indirect allocators.
Step 6: Based on the survey data, calculate direct and indirect PE
percentages for each physician specialty.
Step 7: Calculate direct and indirect PE percentages at the service
level by taking a weighted average of the results of Step 6 for the
specialties that furnish the service. Note that for services with TCs
and PCs, the direct and indirect percentages for a given service do not
vary by the PC, TC, and global service.
We generally use an average of the 3 most recent years of available
Medicare claims data to determine the specialty mix assigned to each
code. Codes with low Medicare service volume require special attention
since billing or enrollment irregularities for a given year can result
in significant changes in specialty mix assignment. We finalized a
policy in the CY 2018 PFS final rule (82 FR 52982 through 59283) to use
the most recent year of claims data to determine which codes are low
volume for the coming year (those that have fewer than 100 allowed
services in the Medicare claims data). For codes that fall into this
category, instead of assigning 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 on an annual basis. Services
for which the specialty is automatically assigned based on previously
finalized policies under our established methodology (for example,
``always therapy'' services) are unaffected by the list of expected
specialty assignments. We also finalized in the CY 2018 PFS final rule
(82 FR 52982 through 52983) a policy to apply these service-level
overrides for both PE and MP, rather than one or the other category.
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 CY 2024. Commenters stated that the purpose of
assigning a specialty to these codes was to avoid the major adverse
impact on MP RVUs that result from errors in specialty utilization data
magnified in representation (percentage) by small sample size. These
commenters submitted a list of several dozen low volume HCPCS codes
with recommended expected specialty assignments.
Response: After reviewing the information provided by the
commenters to determine that the submitted specialty assignments were
appropriate for the services in question, 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 CPT
code 33230 should be crosswalked to the Cardiac Electrophysiology
specialty and that CPT code 96446 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 Cardiology and Obstetrics/Gynecology specialties, respectively, as
listed on Table 1.
We disagreed with the commenters that CPT code 44384 should be
[[Page 78823]]
crosswalked to the Gastroenterology specialty and that CPT code 60505
should be crosswalked to the General Surgery specialty. In each case,
there was another specialty which was reported more than twice as often
in the claims data as the requested specialty. Therefore, we are
crosswalking CPT code 44384 to the Urology specialty and CPT code 60505
to the Otolaryngology specialty as these were the dominant specialties
in the claims data. These crosswalks are included in Table 1.
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Comment: A commenter noted that the CMS expected specialty
assignment list in the public use file that was part of the CY 2024
proposed rule also includes a column specifying if a service that
previously had an anticipated specialty override continues to meet the
criteria for the override to be applied for CY 2024. The commenter
provided a list of approximately a dozen CPT codes and requested
additional information as to why the expected specialty override was
not being applied in these cases.
Response: We reviewed the CPT codes identified by the commenter and
can provide the following information about their expected specialty
override status for CY 2024. CMS did not apply the specialty override
to CPT codes 33238, 33254, 33475, and 33507 as each code exceeded 100
allowed services in the Medicare claims data. CMS did not apply the
specialty override to CPT codes 33602, 33619, 33778, and 43045 because
they were unneeded, with the entirety of their very small number of
allowed services already reported under their expected specialty. CPT
codes 33600, 33710, and 43312 did have their respective specialty
overrides applied; this was correctly detailed in the public use file
for the CY 2024 proposed rule for CPT code 43312 but was missing from
CPT codes 33600 and 33710, due to a technical error in the generation
of the public use file.
We also note for commenters that each HCPCS code that appears on
the list of expected specialty assignments for low volume services
remains on the list from year to year, even if the code in question is
not a low volume service for a certain calendar year because the volume
rises to over 100 services. The HCPCS codes and expected specialty
assignment remain on the list, and will be applied should the code fall
below the low volume threshold (below 100 services) in any calendar
year; as a result, there is no need to ``reactivate'' individual codes
as some commenters have suggested in past submissions.
After consideration of the public comments, we are finalizing the
updates to the list of expected specialty assignments for low volume
services as detailed Table 1.
Step 8: Calculate the service level allocators for the indirect PEs
based on the percentages calculated in Step 7. The indirect PEs are
allocated based on the three components: the direct PE RVUs; the
clinical labor PE RVUs; and the work RVUs.
For most services the indirect allocator is: indirect PE percentage
* (direct PE RVUs/direct percentage) + work RVUs.
There are two situations where this formula is modified:
If the service is a global service (that is, a service
with global, professional, and technical components), then the indirect
PE allocator is: indirect percentage (direct PE RVUs/direct percentage)
+ clinical labor PE RVUs + work RVUs.
If the clinical labor PE RVUs exceed the work RVUs (and
the service is not a global service), then the indirect allocator is:
indirect PE percentage (direct PE RVUs/direct percentage) + clinical
labor PE RVUs.
(Note: For global services, the indirect PE allocator is based on
both the work RVUs and the clinical labor PE RVUs. We do this to
recognize that, for the PC service, indirect PEs would be allocated
using the work RVUs, and for the TC service, indirect PEs would be
allocated using the direct PE RVUs and the clinical labor PE RVUs. This
also allows the global component RVUs to equal the sum of the PC and TC
RVUs.)
For presentation purposes, in the examples in the download file
titled ``Calculation of PE RVUs under Methodology for Selected Codes'',
the formulas were divided into two parts for each service.
The first part does not vary by service and is the
indirect percentage (direct PE RVUs/direct percentage).
The second part is either the work RVU, clinical labor PE
RVU, or both depending on whether the service is a global service and
whether the clinical PE RVUs exceed the work RVUs (as described earlier
in this step).
Apply a scaling adjustment to the indirect allocators.
Step 9: Calculate the current aggregate pool of indirect PE RVUs by
multiplying the result of step 8 by the average indirect PE percentage
from the survey data.
Step 10: Calculate an aggregate pool of indirect PE RVUs for all
PFS services by adding the product of the indirect PE allocators for a
service from Step 8 and the utilization data for that service.
Step 11: Using the results of Step 9 and Step 10, calculate an
indirect PE adjustment so that the aggregate indirect allocation does
not exceed the available aggregate indirect PE RVUs and apply it to
indirect allocators calculated in Step 8.
Calculate the indirect practice cost index.
Step 12: Using the results of Step 11, calculate aggregate pools of
specialty specific adjusted indirect PE allocators for all PFS services
for a specialty by adding the product of the adjusted indirect PE
allocator for each service and the utilization data for that service.
Step 13: Using the specialty specific indirect PE/HR data,
calculate specialty specific aggregate pools of indirect PE for all PFS
services for that specialty by adding the product of the indirect PE/HR
for the specialty, the work time for the service, and the specialty's
utilization for the service across all services furnished by the
specialty.
Step 14: Using the results of Step 12 and Step 13, calculate the
specialty specific indirect PE scaling factors.
Step 15: Using the results of Step 14, calculate an indirect
practice cost index at the specialty level by dividing each specialty
specific indirect scaling factor by the average indirect scaling factor
for the entire PFS.
Step 16: Calculate the indirect practice cost index at the service
level to ensure the capture of all indirect costs. Calculate a weighted
average of the practice cost index values for the specialties that
furnish the service. (Note: For services with TCs and PCs, we calculate
the indirect practice cost index across the global service, PCs, and
TCs. Under this method, the indirect practice cost index for a given
service (for example, echocardiogram) does not vary by the PC, TC, and
global service.)
Step 17: Apply the service level indirect practice cost index
calculated in Step 16 to the service level adjusted indirect allocators
calculated in Step 11 to get the indirect PE RVUs.
[[Page 78826]]
(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 refer readers to the CY 2016 PFS final rule with comment
period (80 FR 70927 through 70931).
Comment: Several commenters referenced the CY 2018 PFS finalized
policy for the adjustment to allocation of indirect PE for some office-
based services, generally services associated with behavioral health
(82 FR 52999 through 53000). Commenters stated that for each of the
services that qualify for the indirect PE allocation adjustment, CMS
first establishes an indirect PE floor using the work RVU for the
qualifying service and the ratio between the indirect PE RVUs and the
work RVUs for the marker code (currently CPT code 99213). Commenters
stated that CMS then identifies the difference between the indirect PE
RVU for the qualifying service produced under standard methodology and
the indirect PE floor; the modified methodology then increases the
allocation of indirect PE RVUs to one quarter of that difference.
Commenters stated that they supported the current policy, since they
believe that the current PFS reimbursement rate methodology undervalues
behavioral health services and recommended that CMS expand the indirect
PE floor methodology by increasing the minimum value for non-facility
indirect PE RVUs by adding the full difference between the indirect PE
floor RVUs and indirect PE RVUs calculated for the eligible codes under
the standard methodology (instead of one quarter of the distance).
Commenters stated that this expansion of the current indirect PE floor
policy would assure that a more appropriate number of indirect PE RVUs
are allocated to these services and would provide greater resources to
behavioral health practitioners providing services to Medicare
beneficiaries with behavioral and mental health needs.
Response: We appreciate the support from the commenters for our
previously finalized policy for the adjustment to allocation of
indirect PE for some office-based services. While we share the concern
of the commenters in ensuring that behavioral health practitioners have
the proper resources that they need to provide services to Medicare
beneficiaries, we note that we did not propose to make any adjustments
to this indirect PE policy for CY 2024 and we are not finalizing any
adjustments to this indirect PE policy for CY 2024. We will consider
the recommendations from the commenters for potential use in future
rulemaking.
(e) Setup File Information
Specialties excluded from ratesetting calculation: For the
purposes of calculating the PE and MP RVUs, we exclude certain
specialties, such as certain NPPs paid at a percentage of the PFS and
low volume specialties, from the calculation. These specialties are
included for the purposes of calculating the BN adjustment. They are
displayed in Table 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
the creation of the file consistent with current payment policy as
implemented in claims processing. For example, services billed with the
assistant at surgery modifier are paid 16 percent of the PFS amount for
that service; therefore, the utilization file is modified to only
account for 16 percent of any service that contains the assistant at
surgery modifier. Similarly, for those services to which volume
adjustments are made to account for the payment modifiers, time
adjustments are applied as well. For time adjustments to surgical
services, the intraoperative portion in the work time file is used;
where it is not present, the intraoperative percentage from the payment
files used by contractors to process Medicare claims is used instead.
Where neither is available, we use the payment adjustment ratio to
adjust the time
[[Page 78828]]
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 note that section
1848(c)(2)(B)(v) of the Act exempts certain reduced payments for
multiple imaging procedures and multiple therapy services from the BN
calculation under section 1848(c)(2)(B)(ii)(II) of the Act. These MPPRs
are not included in the development of the RVUs.
Beginning in CY 2022, section 1834(v)(1) of the Act required that
we apply a 15 percent payment reduction for outpatient occupational
therapy services and outpatient physical therapy services that are
provided, in whole or in part, by a physical therapist assistant (PTA)
or occupational therapy assistant (OTA). Section 1834(v)(2)(A) of the
Act required CMS to establish modifiers to identify these services,
which we did in the CY 2019 PFS final rule (83 FR 59654 through 59661),
creating the CQ and CO payment modifiers for services provided in whole
or in part by PTAs and OTAs, respectively. These payment modifiers are
required to be used on claims for services with dates of service
beginning January 1, 2020, as specified in the CY 2020 PFS final rule
(84 FR 62702 through 62708). We applied the 15 percent payment
reduction to therapy services provided by PTAs (using the CQ modifier)
or OTAs (using the CO modifier), as required by statute. Under sections
1834(k) and 1848 of the Act, payment is made for outpatient therapy
services at 80 percent of the lesser of the actual charge or applicable
fee schedule amount (the allowed charge). The remaining 20 percent is
the beneficiary copayment. For therapy services to which the new
discount applies, payment will be made at 85 percent of the 80 percent
of allowed charges. Therefore, the volume discount factor for therapy
services to which the CQ and CO modifiers apply is: (0.20 + (0.80*
0.85), which equals 88 percent.
For anesthesia services, we do not apply adjustments to volume
since we use the average allowed charge when simulating RVUs;
therefore, the RVUs as calculated already reflect the payments as
adjusted by modifiers, and no volume adjustments are necessary.
However, a time adjustment of 33 percent is made only for medical
direction of two to four cases since that is the only situation where a
single practitioner is involved with multiple beneficiaries
concurrently, so that counting each service without regard to the
overlap with other services would overstate the amount of time spent by
the practitioner furnishing these services.
Work RVUs: The setup file contains the work RVUs from this
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)- 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 final rule.
price = price of the particular piece of equipment.
life of equipment = useful life of the particular piece of
equipment.
maintenance = factor for maintenance; 0.05.
interest rate = variable, see discussion below in this final rule.
Usage: We currently use an equipment utilization rate assumption of
50 percent for most equipment, with the exception of expensive
diagnostic imaging equipment, for which we use a 90 percent assumption
as required by section 1848(b)(4)(C) of the Act.
Useful Life: In the CY 2005 PFS final rule we stated that we
updated the useful life for equipment items primarily based on the
AHA's ``Estimated Useful Lives of Depreciable Hospital Assets''
guidelines (69 FR 66246). The most recent edition of these guidelines
was published in 2018. This reference material provides an estimated
useful life for hundreds of different
[[Page 78829]]
types of equipment, the vast majority of which fall in the range of 5
to 10 years, and none of which are lower than 2 years in duration. We
believe that the updated editions of this reference material remain the
most accurate source for estimating the useful life of depreciable
medical equipment.
In the CY 2021 PFS final rule, we finalized a proposal to treat
equipment life durations of less than 1 year as having a duration of 1
year for the purpose of our equipment price per minute formula. In the
rare cases where items are replaced every few months, we noted that we
believe it is more accurate to treat these items as disposable supplies
with a fractional supply quantity as opposed to equipment items with
very short equipment life durations. For a more detailed discussion of
the methodology associated with very short equipment life durations, we
referred readers to the CY 2021 PFS final rule (85 FR 84482 through
84483).
Maintenance: We finalized the 5 percent factor for annual
maintenance in the CY 1998 PFS final rule with comment period (62 FR
33164). As we previously stated in the CY 2016 PFS final rule with
comment period (80 FR 70897), we do not believe the annual maintenance
factor for all equipment is precisely 5 percent, and we concur that the
current rate likely understates the true cost of maintaining some
equipment. We also noted that we believe it likely overstates the
maintenance costs for other equipment. When we solicited comments
regarding sources of data containing equipment maintenance rates,
commenters were unable to identify an auditable, robust data source
that could be used by CMS on a wide scale. We noted that we did not
believe voluntary submissions regarding the maintenance costs of
individual equipment items would be an appropriate methodology for
determining costs. As a result, in the absence of publicly available
datasets regarding equipment maintenance costs or another systematic
data collection methodology for determining a different maintenance
factor, we did not propose a variable maintenance factor for equipment
cost per minute pricing as we did not believe that we have sufficient
information at present. We noted that we would continue to investigate
potential avenues for determining equipment maintenance costs across a
broad range of equipment items.
Interest Rate: In the CY 2013 PFS final rule with comment
period (77 FR 68902), we updated the interest rates used in developing
an equipment cost per minute calculation (see 77 FR 68902 for a
thorough discussion of this issue). The interest rate was based on the
Small Business Administration (SBA) maximum interest rates for
different categories of loan size (equipment cost) and maturity (useful
life). The Interest rates are listed in Table 4.
[GRAPHIC] [TIFF OMITTED] TR16NO23.004
We did not propose any changes to the equipment interest rates for
CY 2024.
3. Adjusting RVUs To Match the PE Share of the Medicare Economic Index
(MEI)
In the past, we have stated that we believe that the MEI is the
best measure available of the relative weights of the three components
in payments under the PFS--work, practice expense (PE), and malpractice
(MP). Accordingly, we believe that to assure that the PFS payments
reflect the relative resources in each of these PFS components as
required by section 1848(c)(3) of the Act, the RVUs used in developing
rates should reflect the same weights in each component as the cost
share weights in the Medicare Economic Index (MEI). In the past, we
have proposed (and subsequently, finalized) to accomplish this by
holding the work RVUs constant and adjusting the PE RVUs, MP RVUs, and
CF to produce the appropriate balance in RVUs among the three PFS
components and payment rates for individual services, that is, that the
total RVUs on the PFS are proportioned to approximately 51 percent work
RVUs, 45 percent PE RVUs, and 4 percent MP RVUs. As the MEI cost shares
are updated, we would typically propose to modify steps 3 and 10 to
adjust the aggregate pools of PE costs (direct PE in step 3 and
indirect PE in step 10) in proportion to the change in the PE share in
the rebased and revised MEI cost share weights, and to recalibrate the
relativity adjustment that we apply in step 18 as described ``3.
Adjusting RVUs To Match PE Share of the Medicare Economic Index (MEI)''
of the CY 2023 PFS final rule (87 FR 69414 and 69415) and CY 2014 PFS
final rule (78 FR 74236 and 74237). The most recent recalibration was
done for the CY 2014 RVUs.
In the CY 2014 PFS proposed rule (78 FR 43287 through 43288) and
final rule (78 FR 74236 through 74237), we detailed the steps necessary
to accomplish this result (see steps 3, 10, and 18). The CY 2014
proposed and final adjustments were consistent with our longstanding
practice to make adjustments to match the RVUs for the PFS components
with the MEI cost share weights for the components, including the
adjustments described in the CY 1999 PFS final rule (63 FR 58829), CY
2004 PFS final rule (68 FR 63246 and 63247), and CY 2011 PFS final rule
(75 FR 73275).
In the CY 2023 PFS final rule (87 FR 69688 through 69711), we
finalized to rebase and revise the Medicare Economic Index (MEI) to
reflect more current market conditions faced by physicians in
furnishing physicians' services. We also finalized a delay of the
adjustments to the PE pools in steps 3 and 10 and the recalibration of
the relativity adjustment in step 18 until the public had an
opportunity to comment on the rebased and revised MEI (87 FR 69414
through 69416). Because we finalized significant methodological and
data source changes to the MEI in the CY 2023 PFS final rule and
significant time has elapsed since the last rebasing and revision of
the MEI in CY 2014, we believed that delaying the
[[Page 78830]]
implementation of the finalized CY 2023 rebased and revised MEI was
consistent with our efforts to balance payment stability and
predictability with incorporating new data through more routine
updates. We refer readers to the discussion of our comment solicitation
in the CY 2023 PFS final rule (87 FR 69429 through 69432), where we
reviewed our ongoing efforts to update data inputs for PE to aid
stability, transparency, efficiency, and data adequacy. We also
solicited comment in the CY 2023 PFS proposed rule on when and how to
best incorporate the CY 2023 rebased and revised MEI into PFS
ratesetting, and whether it would be appropriate to consider a
transition to full implementation for potential future rulemaking. We
presented the impacts of implementing the rebased and revised MEI in
PFS ratesetting through a 4-year transition and through full immediate
implementation, that is, with no transition period in the CY 2023 PFS
proposed rule. We also solicited comment on other implementation
strategies for potential future rulemaking in the CY 2023 PFS proposed
rule. In the CY 2023 PFS final rule, we discussed that many commenters
supported our proposed delayed implementation and many commenters
expressed concerns with the redistributive impacts of the
implementation of the rebased and revised MEI in PFS ratesetting. Many
commenters also noted that the AMA has stated it intends to collect
practice cost data from physician practices in the near future which
could be used to derive cost share weights for the MEI and RVU shares.
In light of the AMA's intended data collection efforts in the near
future and because the methodological and data source changes to the
MEI finalized in the CY 2023 PFS final rule would have significant
impacts on PFS payments, we continue to believe that delaying the
implementation of the finalized 2017-based MEI cost share weights for
the RVUs is consistent with our efforts to balance payment stability
and predictability with incorporating new data through more routine
updates. Therefore, we did not propose to incorporate the 2017-based
MEI in PFS ratesetting for CY 2024.
As discussed above, in the CY 2023 PFS rulemaking, we finalized to
rebase and revise the MEI to reflect more current market conditions
faced by physicians in furnishing physicians' services. The final 2017-
based MEI relies on a methodology that uses publicly available data
sources for input costs that represent all types of physician practice
ownership, not limited to only self-employed physicians. The 2006-based
MEI relied on the 2006 AMA PPIS survey data; as of this CY 2024
rulemaking, this survey had not been updated. Given the changes in the
physician and supplier industry and the time since the last update to
the base year, we finalized a methodology that would allow us to update
the MEI on a consistent basis in the future. The 2017-based MEI cost
share weights are derived predominantly from the annual expense data
from the U.S. Census Bureau's Services Annual Survey (SAS, https://www.census.gov/programs-surveys/sas.html). We supplement the 2017 SAS
expense data by using several data sources to further disaggregate
compensation costs and all other residual costs (87 FR 69688 through
69708).
We continue to review more recently available data from the Census
Bureau Services Annual Survey, the main data source for the major
components of the 2017-based MEI cost share weights. Data is currently
available through 2021. Given that the impact of the PHE may influence
the 2020 and 2021 data, we continue to evaluate whether the recent
trends are reflective of sustained shifts in cost structures or were
temporary as a result of the COVID-19 PHE. The 2022 data from the
Services Annual Survey will be available later this year. We will
monitor that data and any other data that may become available related
to physician services' input expenses and will propose any changes to
the MEI, if appropriate, in future rulemaking.
The following is a summary of the comments we received and our
responses.
Comment: Many commenters supported our continued delayed
implementation of the rebased and revised MEI in PFS ratesetting. Most
of these commenters urged CMS to pause consideration of other sources
for the MEI until the AMA's efforts to collect practice cost data from
physician practices have concluded. A few commenters urged CMS to
implement the MEI for PFS ratesetting as soon as possible.
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 the methodology for deriving the
2017-based MEI cost share weights is flawed because the use of the SAS
data as the primary data source for expenses omits facility-based
physicians which, according to BLS Occupational Employment and Wage
Statistics (OEWS) data, accounts for 36 percent of physicians who are
employed in the health sector. The commenter states that correcting for
the omission would result in an increase to the physician work cost
share weight and a much smaller reduction to the professional liability
insurance (PLI) cost share weight in the MEI.
The commenter noted that in response to a similar comment in the CY
2023 PFS final rule, CMS responded that ``for physicians who are
employed in other healthcare settings directly, such as hospitals, we
do not believe that including costs for physicians that do not incur
any operating expenses associated with running a practice would be
technically appropriate.'' However, the commenter stated that this
fails to consider that the MEI cost share weights also cover physician
compensation and professional liability insurance. The commenter stated
that by excluding NAICS 6221 General Medical and Surgical Hospitals in
the CMS MEI cost share weights analysis, CMS inadvertently omitted over
$30 billion in physician compensation and over $7 billion in
professional liability insurance compensation. Also, the commenter
noted that physician practices do still have some indirect PE costs
even for providers who are solely facility-based (coding, billing,
scheduling, etc.). The commenter claimed that the CMS analysis of the
US Census SAS data captured a large majority of PE covered by the PFS
but only a subset of the physician compensation and professional
liability insurance premiums.
The commenter requested that CMS make changes to the methodology
for deriving the MEI cost share weights to correct for the omission of
costs for facility-based physicians.
Response: We appreciate the commenter's concern regarding the
methodology for the 2017-based MEI. As explained in the 2023 PFS final
rule (87 FR 69688 through 69710), the development of the MEI cost share
weights (which would reflect all costs including work, PE and PLI) is
intended to be consistent with costs associated with providing
physician services as paid for by the PFS. Thus, we are using a data
source that reflects the nature of those costs, which we have
determined to be the U.S. Census Bureau's Services Annual Survey. This
data source shows all ownership types of physicians' offices as
determined by the North American Industrial Classification System
(NAICS). Unfortunately, there is currently no data source available
that would provide a comprehensive
[[Page 78831]]
collection of physician expense data for physicians that directly
contract with hospitals or other healthcare settings. While there are
compensation costs for employed physicians working in an alternative
setting such as a hospital or SNF and other associated expenses,
including those for PLI, those costs would be captured in reporting for
those other settings--such as hospitals, home health agencies, or
skilled nursing facilities. For example, if a physician is directly
employed by a hospital, that is, not just a hospital-owned physician
practice, then those costs would be captured in the reported SAS
expenses for NAICS 622 (Hospitals) and on the Medicare cost report
submitted by the hospital. Unfortunately, there is currently no
mechanism for identifying those specific expenses distinct to providing
physician services separately from the provider's other expenses.
Therefore, we have used a data source that we believe reflects the most
up-to-date, comprehensive, and regularly published data on physician
expenses for the majority of physicians (which would be captured in
NAICS 621111--Offices of Physicians). We welcome the public to provide
any other data source that could be considered, in concert with the SAS
data, to address the commenters concerns. Additionally, we understand
that the AMA is currently collecting data on physician expenses and we
will analyze the data if made available to CMS. We note that CMS did
not propose changes to the methodology for deriving the MEI cost share
weights for CY 2024.or.
4. Changes to Direct PE Inputs for Specific Services
This section focuses on specific PE inputs. The direct PE inputs
are included in the CY 2024 direct PE input public use files, which are
available on the CMS website under downloads for the CY 2024 PFS final
rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
a. Standardization of Clinical Labor Tasks
As we noted in the CY 2015 PFS final rule with comment period (79
FR 67640 through 67641), we continue to make improvements to the direct
PE input database to provide the number of clinical labor minutes
assigned for each task for every code in the database instead of only
including the number of clinical labor minutes for the preservice,
service, and post service periods for each code. In addition to
increasing the transparency of the information used to set PE RVUs,
this level of detail would allow us to compare clinical labor times for
activities associated with services across the PFS, which we believe is
important to maintaining the relativity of the direct PE inputs. This
information would facilitate the identification of the usual numbers of
minutes for clinical labor tasks and the identification of exceptions
to the usual values. It would also allow for greater transparency and
consistency in the assignment of equipment minutes based on clinical
labor times. Finally, we believe that the detailed information can be
useful in maintaining standard times for particular clinical labor
tasks that can be applied consistently to many codes as they are valued
over several years, similar in principle to the use of physician
preservice time packages. We believe that setting and maintaining such
standards would provide greater consistency among codes that share the
same clinical labor tasks and could improve relativity of values among
codes. For example, as medical practice and technologies change over
time, changes in the standards could be updated simultaneously for all
codes with the applicable clinical labor tasks, instead of waiting for
individual codes to be reviewed.
In the CY 2016 PFS final rule with comment period (80 FR 70901), we
solicited comments on the appropriate standard minutes for the clinical
labor tasks associated with services that use digital technology. After
consideration of comments received, we finalized standard times for
clinical labor tasks associated with digital imaging at 2 minutes for
``Availability of prior images confirmed'', 2 minutes for ``Patient
clinical information and questionnaire reviewed by technologist, order
from physician confirmed and exam protocoled by radiologist'', 2
minutes for ``Review examination with interpreting MD'', and 1 minute
for ``Exam documents scanned into PACS'' and ``Exam completed in RIS
system to generate billing process and to populate images into
Radiologist work queue.'' In the CY 2017 PFS final rule (81 FR 80184
through 80186), we finalized a policy to establish a range of
appropriate standard minutes for the clinical labor activity,
``Technologist QCs images in PACS, checking for all images, reformats,
and dose page.'' These standard minutes will be applied to new and
revised codes that make use of this clinical labor activity when they
are reviewed by us for valuation. We finalized a policy to establish 2
minutes as the standard for the simple case, 3 minutes as the standard
for the intermediate case, 4 minutes as the standard for the 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
[[Page 78832]]
CA014 clinical labor activity code did not contain any clinical labor
for the CA007 activity. In these situations, we continue to believe
that in these cases, the 3 total minutes of clinical staff time would
be more accurately described by the CA013 ``Prepare room, equipment and
supplies'' activity code, and we finalized these clinical labor
refinements. For additional details, we direct readers to the
discussion in the CY 2019 PFS final rule (83 FR 59463 through 59464).
Following the publication of the CY 2020 PFS proposed rule, one
commenter expressed concern with the published list of common
refinements to equipment time. The commenter stated that these
refinements were the formulaic result of the applying refinements to
the clinical labor time and did not constitute separate refinements;
the commenter requested that CMS no longer include these refinements in
the table published each year. In the CY 2020 PFS final rule, we agreed
with the commenter that these equipment time refinements did not
reflect errors in the equipment recommendations or policy discrepancies
with the RUC's equipment time recommendations. However, we believed
that it was important to publish the specific equipment times that we
were proposing (or finalizing in the case of the final rule) when they
differed from the recommended values due to the effect that these
changes can have on the direct costs associated with equipment time.
Therefore, we finalized the separation of the equipment time
refinements associated with changes in clinical labor into a separate
table of refinements. For additional details, we direct readers to the
discussion in the CY 2020 PFS final rule (84 FR 62584).
Historically, the RUC has submitted a ``PE worksheet'' that details
the recommended direct PE inputs for our use in developing PE RVUs. The
format of the PE worksheet has varied over time and among the medical
specialties developing the recommendations. These variations have made
it difficult for both the RUC's development and our review of code
values for individual codes. Beginning with its recommendations for CY
2019, the RUC has mandated the use of a new PE worksheet for purposes
of their recommendation development process that standardizes the
clinical labor tasks and assigns them a clinical labor activity code.
We believe the RUC's use of the new PE worksheet in developing and
submitting recommendations will help us to simplify and standardize the
hundreds of different clinical labor tasks currently listed in our
direct PE database. As we did in previous calendar years, to facilitate
rulemaking for CY 2024, 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 2024 PFS final rule at
http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
b. Updates to Prices for Existing Direct PE Inputs
In the CY 2011 PFS final rule with comment period (75 FR 73205), we
finalized a process to act on public requests to update equipment and
supply price and equipment useful life inputs through annual
rulemaking, beginning with the CY 2012 PFS proposed rule. Beginning in
CY 2019 and continuing through CY 2022, we conducted a market-based
supply and equipment pricing update, using information developed by our
contractor, StrategyGen, which updated pricing recommendations for
approximately 1,300 supplies and 750 equipment items currently used as
direct PE inputs. Given the potentially significant changes in payment
that would occur, in the CY 2019 PFS final rule we finalized a policy
to phase in our use of the new direct PE input pricing over a 4-year
period using a 25/75 percent (CY 2019), 50/50 percent (CY 2020), 75/25
percent (CY 2021), and 100/0 percent (CY 2022) split between new and
old pricing. We believed that implementing the proposed updated prices
with a 4-year phase-in would improve payment accuracy, while
maintaining stability and allowing interested parties the opportunity
to address potential concerns about changes in payment for particular
items. This 4-year transition period to update supply and equipment
pricing concluded in CY 2022; for a more detailed discussion, we refer
readers to the CY 2019 PFS final rule with comment period (83 FR 59473
through 59480).
For CY 2024, we proposed to update the price of 16 supplies and two
equipment items in response to the public submission of invoices
following the publication of the CY 2023 PFS final rule. The 16 supply
and equipment items with proposed updated prices were listed in the
valuation of specific codes section of the preamble under Table 15, CY
2024 Invoices Received for Existing Direct PE Inputs (88 FR 52348).
We did not propose to update the price of another eleven supplies
which were the subject of public submission of invoices. Our rationale
for not updating these prices is detailed below:
Extended external ECG patch, medical magnetic tape
recorder (SD339): We received additional invoices for the SD339 supply
from an interested party. Upon review of the invoices, we determined
that they contained the identical price point that we previously
incorporated into last year's rule when we finalized a price of $260.35
for the supply item (87 FR 69514 through 69516). Since these invoices
did not contain any new information, we stated in the proposed rule
that we are maintaining the previously finalized price of $260.35 for
the SD339 supply.
Permanent marking pen (SL477), Liquid coverslip (Ventana
650-010) (SL479), EZ Prep (10X) (Ventana 950-102) (SL481), Cell
Conditioning 1 (Ventana 950-124) (SL482), and Hematoxylin II (Ventana
790-2208) (SL483): We received invoices from interested parties for use
in updating the price of these laboratory supplies. In each case,
however, we were able to find the same supply item available for sale
online at the current price or cheaper. Therefore, we do not believe
that the submitted invoices represent typical market pricing for these
supplies and we did not propose to update their prices.
Mask, surgical (SB033), scalpel with blade, surgical (#10-
20) (SF033), eye shield, non-fog (SG049), gauze, non-sterile 4in x 4in
(SG051), and towel, paper (Bounty) (per sheet) (SK082): We received
invoices from interested parties for use in updating the price of these
common supply items. In each case, we received a single invoice and
once again we were able to find the same supply items available for
sale online at the current price or cheaper. Generally speaking, we
avoid updating the price for common supply items like the SB033
surgical mask (included in approximately 380 HCPCS codes) based on the
submission of a single invoice, as an invoice unrepresentative of
current market pricing will have far-reaching effects across the PFS.
We did not find that the typical price for a surgical mask had
increased by more than 60 percent since the supply and equipment
pricing update concluded in CY 2022, and as such we stated in the
proposed rule that we are maintaining the current price for these
supply items.
[[Page 78833]]
We received the following comments on our proposed updates to
supply and equipment pricing:
Comment: Several commenters stated that they supported the proposed
pricing updates of the following supplies and equipment items: SC084,
SC085, SM008, SL491, EP034, EP111, SA110, SL077, SL495, SL475, SL488,
SL474, and SL486. The commenters urged CMS to finalize the updates as
proposed.
Response: We appreciate the support for our proposed pricing from
the commenters.
Comment: A commenter stated that they had submitted invoices during
the pre-rulemaking period, in February 2023, to support CMS with
identifying the appropriate direct PE inputs for equipment and supplies
used in physician pathology services. The commenter listed ten supply
and equipment items with updated pricing in the proposed rule (EP034,
EP111, SA110, SL077, SL474, SL475, SL486, SL488, SL491, SL495) and
stated that they supported the proposed pricing changes for these items
and urged CMS to finalize them as proposed in the final rule.
Response: We appreciate the support for our proposed pricing from
the commenter.
Comment: Several commenters stated that they appreciated CMS'
conclusion that the current price of $260.35 should be maintained for
supply item SD339 (extended external ECG patch, medical magnetic tape
recorder) for CY 2024. The commenters stated that the proposed pricing
represented much-needed payment stability for providers of the long
term electrocardiographic (LT-ECG) monitoring service and it was in the
best interest of Medicare beneficiaries for CMS to support continued
patient access to these services through the maintenance of fair and
stable provider reimbursement.
Response: We appreciate the support for our proposed pricing from
the commenters.
Comment: A commenter submitted approximately 50 invoices with the
intention of persuading CMS to update the pricing for the Tubing set,
blood warmer (SC084) and Tubing set, plasma exchange (SC085) supplies.
The commenter stated that these invoices were based on sales to U.S.
customers in June and July 2023 and requested that CMS update their
prices to reflect the data contained on the invoices.
Response: We appreciate the large quantity of pricing data provided
by the commenter for use in updating the pricing of the SC084 and SC085
supplies. After reviewing the invoices, we agree with the commenter
that the Tubing set, blood warmer (SC084) supply is more accurately
priced at $16.27 and the Tubing set, plasma exchange (SC085) supply is
more accurately priced at $277.20. We are finalizing these updated
prices based on the market-based pricing contained in this large sample
of submitted invoices.
The following are additional comments that we received associated
with supply and equipment pricing:
Comment: A commenter stated that the non-facility reimbursement is
significantly undervalued for CPT code 36836 (Percutaneous
arteriovenous fistula creation, upper extremity, single access of both
the peripheral artery and peripheral vein, including fistula maturation
procedures (e.g., transluminal balloon angioplasty, coil embolization)
when performed, including all vascular access, imaging guidance and
radiologic supervision and interpretation). The commenter stated that
an angiography room (EL011) should be included in the equipment item
inputs for CPT code 36836, since it is included in CPT code 36837,
instead of the current vascular ultrasound room (EL016). The commenter
also stated that CMS should update the pricing for the Ellipsys
Vascular Access Catheter (SD351) supply item as the price of $6,000 is
not representative of the current cost of the device. The commenter
submitted approximately 70 invoices with the intention of persuading
CMS to update the pricing for the SD351 supply to $7,378.75.
Response: We disagree with the commenter that the use of an
angiography room would be more typical than the use of a vascular
ultrasound room for CPT code 36837; the vascular ultrasound room was
recommended by the RUC and finalized by CMS in CY 2023 rulemaking (87
FR 69485 through 69489). However, we appreciate the submission of a
large quantity of pricing data provided by the commenter for use in
updating the pricing of the SD351 supply. We previously wrote in CY
2023 rulemaking that we were concerned that the submission of a single
invoice would represent an increase from $6,000 to $8,950 for the SD351
supply, an extraordinary increase in the span of 6 months since the
service was reviewed at the January 2022 RUC meeting, and that we would
consider supply pricing in future updates to this service.
With the much larger batch of invoice data supplied by the
commenter, it is clear that the Ellipsys Vascular Access Catheter
(SD351) supply item has a bimodal pricing structure, with almost
exactly half of the submitted invoices listed at the current price of
$6,000 while the other half were priced at $8,950. Based on this
updated pricing data, we therefore agree that the commenter's suggested
price change to $7,378.75 is an appropriate update to the price of the
SD351 supply as it falls between the two poles of the pricing
distribution. We are finalizing this update to the price of the SD351
supply to more accurately reflect the typical market price.
Comment: A commenter submitted a series of approximately 100
invoices for use in pricing a new supply item known as the WatchPAT One
device. The commenter stated that this was a separate supply from the
WatchPAT pneumo-opt slp probes (SD263) item currently listed in the CMS
supply database priced at $73.32. The commenter detailed the clinical
benefits associated with the WatchPAT One device and provided to CMS
copies of purchase invoices reflecting sales of approximately 3,000
units across all geographic regions of the country to support the
commenter's requested value of $98.20 for the supply item.
Response: We appreciate the submission of this large quantity of
pricing data associated with the WatchPAT One device. Although there
are no HCPCS codes that currently include the WatchPAT One device as a
supply item, we will add the WatchPAT One device to our supply database
with its own supply code (SD362) at the requested price of $98.20 so
that it can be used in future reviews of services that typically make
use of this product.
Comment: A commenter stated that there are numerous discrepancies
between the aggregated cost of some of the supply packs and the
individual item components contained within. The commenter stated that
these mathematical errors should be rectified as soon as possible by
CMS to ensure that the sum correctly matches the totals from the
individual items, and the commenter recommended that CMS resolve these
pricing discrepancies in the supply packs during CY 2024 rulemaking.
The commenter submitted RUC workgroup recommendations to update pricing
for a series of supply packs along with their comment letter.
Response: We appreciate the additional information and RUC
workgroup recommendations provided by the commenter 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
[[Page 78834]]
rule, we believe 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 believe that interested
parties will be better served if CMS addresses this topic in a
comprehensive manner during a potential future rulemaking in which
commenters could provide feedback in response to proposed pricing
updates.
Comment: A commenter reviewed the issue of skin adhesives and
identified several generic alternatives to the use of the skin adhesive
(Dermabond) (SG007) supply. The commenter stated that there are
multiple skin adhesive products, at different price points, available
that work similarly to Dermabond and requested that generic
alternatives should be used overall in place of brand names in the CMS
supply database. The commenter 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.
Response: We note that these revisions to the skin adhesive
supplies were incorporated into the recommendations from the April 2023
RUC meeting where several skin adhesive procedures were reviewed. As we
stated with respect to the pricing of supply packs above, we believe
that this issue would be better addressed in a potential future
rulemaking, for example as part of the RUC review of these skin
adhesive procedures for the upcoming CY 2025 cycle. This would allow
CMS to make any potential revisions to the skin adhesive supplies while
the HCPCS codes in question are also under formal review to minimize
disruption to existing services.
Comment: Several commenters recommended that CMS separately
identify and pay for high-cost disposable supplies. Commenters stated
that this would address the outsized impact that high-cost disposable
supplies have within the current PE RVU methodology; if high cost
supplies were paid separately with appropriate HCPCS codes, their
indirect expense would no longer be associated with that service.
Commenters stated that the result would be that indirect PE RVUs would
be redistributed throughout the specialty PE pool and the PE for all
other services. Commenters recommended that CMS separately identify and
pay for high-cost disposable supplies priced more than $500 using
appropriate HCPCS codes.
Response: We have received a number of prior requests from
interested parties, including the RUC, to implement 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. (For a
discussion of this issue, we direct the reader to our discussion in the
CY 2011 PFS final rule with comment period (75 FR 73251)).
After consideration of the comments, we are finalizing updates to
the pricing of the supply and equipment items as listed in Table 17 and
detailed above. These supply and equipment items with updated prices
are listed in the valuation of specific codes section of the preamble
under Table 17, CY 2024 Invoices Received for Existing Direct PE
Inputs.
(1) Invoice Submission
We remind readers that we routinely accept public submission of
invoices as part of our process for developing payment rates for new,
revised, and potentially misvalued codes. Often these invoices are
submitted in conjunction with the RUC-recommended values for the codes.
To be included in a given year's proposed rule, we generally need to
receive invoices by the same February 10th deadline we noted for
consideration of RUC recommendations. However, we will consider
invoices submitted as public comments during the comment period
following the publication of the PFS proposed rule and would consider
any invoices received after February 10th or outside of the public
comment process as part of our established annual process for requests
to update supply and equipment prices. Interested parties are
encouraged to submit invoices with their public comments or, if outside
the notice and comment rulemaking process, via email at
[email protected].
c. Clinical Labor Pricing Update
Section 220(a) of the PAMA provides that the Secretary may collect
or obtain information from any eligible professional or any other
source on the resources directly or indirectly related to furnishing
services for which payment is made under the PFS, and that such
information may be used in the determination of relative values for
services under the PFS. Such information may include the time involved
in furnishing services; the amounts, types, and prices of PE inputs;
overhead and accounting information for practices of physicians and
other suppliers, and any other elements that would improve the
valuation of services under the PFS.
Beginning in CY 2019, we updated the supply and equipment prices
used for PE as part of a market-based pricing transition; CY 2022 was
the final year of this 4-year transition. We initiated a market
research contract with StrategyGen to conduct an in-depth and robust
market research study to update the supply and equipment pricing for CY
2019, and we finalized a policy in CY 2019 to phase in the new pricing
over a period of 4 years. However, we did not propose to update the
clinical labor pricing, and the pricing for clinical labor has remained
unchanged during this pricing transition. Clinical labor rates were
last updated for CY 2002 using Bureau of Labor Statistics (BLS) data
and other supplementary sources where BLS data were not available; we
refer readers to the full discussion in the CY 2002 PFS final rule for
additional details (66 FR 55257 through 55262).
Interested parties raised concerns that the long delay since
clinical labor pricing was last updated created a significant disparity
between CMS' clinical wage data and the market average for clinical
labor. In recent years, a number of interested parties suggested that
certain wage rates were inadequate because they did not reflect current
labor rate information. Some interested parties also stated that
updating the supply and equipment pricing without updating the clinical
labor pricing could create distortions in the allocation of direct PE.
They argued that since the pool of aggregated direct PE inputs is
budget neutral, if these rates are not routinely updated, clinical
labor may become undervalued over time relative to equipment and
supplies, especially since the supply and equipment prices are in the
process of being updated. There was considerable interest among
interested parties in updating the clinical labor rates, and when we
solicited comment on this topic in past rules, such as in the CY 2019
PFS final rule (83 FR 59480), interested parties supported the idea.
Therefore, we proposed to update the clinical labor pricing for CY
2022, in conjunction with the final year of the supply and equipment
pricing update (86 FR 39118 through 39123). We
[[Page 78835]]
believed it was important to update the clinical labor pricing to
maintain relativity with the recent supply and equipment pricing
updates. We proposed to use the methodology outlined in the CY 2002 PFS
final rule (66 FR 55257), which draws primarily from BLS wage data, to
calculate updated clinical labor pricing. As we stated in the CY 2002
PFS final rule, the BLS' reputation for publishing valid estimates that
are nationally representative led to the choice to use the BLS data as
the main source. We believe that the BLS wage data continues to be the
most accurate source to use as a basis for clinical labor pricing and
this data will appropriately reflect changes in clinical labor resource
inputs for purposes of setting PE RVUs under the PFS. We used the most
current BLS survey data (2019) as the main source of wage data for our
CY 2022 clinical labor proposal.
We recognized that the BLS survey of wage data does not cover all
the staff types contained in our direct PE database. Therefore, we
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, as opposed to mean BLS wage data, in response to
comments in the CY 2022 PFS final rule. To account for the employers'
cost of providing fringe benefits, such as sick leave, we finalized the
use of a benefits multiplier of 1.296 based on a BLS release from June
17, 2021 (USDL-21-1094). As an example of this process, for the
Physical Therapy Aide (L023A) clinical labor type, the BLS data
reflected a median hourly wage rate of $12.98, which we multiplied by
the 1.296 benefits modifier and then divided by 60 minutes to arrive at
the finalized per-minute rate of $0.28.
After considering the comments on our CY 2022 proposals, we agreed
with commenters that the use of a multi-year transition would help
smooth out the changes in payment resulting from the clinical labor
pricing update, avoiding potentially disruptive changes in payment for
affected interested parties, and promoting payment stability from year-
to-year. We believed it would be appropriate to use a 4-year
transition, as we have for several other broad-based updates or
methodological changes. While we recognized that using a 4-year
transition to implement the update means that we will continue to rely
in part on outdated data for clinical labor pricing until the change is
fully completed in CY 2025, we agreed with the commenters that these
significant updates to PE valuation should be implemented in the same
way, and for the same reasons, as for other major updates to pricing
such as the recent supply and equipment update. Therefore, we finalized
the implementation of the clinical labor pricing update over 4 years to
transition from current prices to the final updated prices in CY 2025.
We finalized the implementation of this pricing transition over 4
years, such that one quarter of the difference between the current
price and the fully phased-in price is implemented for CY 2022, one
third of the difference between the CY 2022 price and the final price
is implemented for CY 2023, and one half of the difference between the
CY 2023 price and the final price is implemented for CY 2024, with the
new direct PE prices fully implemented for CY 2025. (86 FR 65025) An
example of the transition from the current to the fully-implemented new
pricing that we finalized in the CY 2022 PFS final rule is provided in
Table 5.
[GRAPHIC] [TIFF OMITTED] TR16NO23.005
(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
[[Page 78836]]
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 Update Proposals
We did not receive new wage data or other additional information
for use in clinical labor pricing from interested parties prior to the
publication of the CY 2024 PFS proposed rule. Therefore, our proposed
clinical labor pricing for CY 2024 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:
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BILLING CODE 4120-01-C
As was the case for the market-based supply and equipment pricing
update, the clinical labor rates will remain open for public comment
over the course of the 4-year transition period. We updated the pricing
of a number of clinical labor types in the CY 2022 and CY 2023 PFS
final rules in response to information provided by commenters. For the
full discussion of the clinical labor pricing update, we direct readers
to the CY 2022 PFS final rule (86 FR 65020 through 65037).
We received the following comments on our clinical labor pricing
update proposals for CY 2024:
Comment: Several commenters stated that CMS created a rank order
anomaly in the pricing of the cytotechnologist (L045A) clinical labor
type when it increased the clinical labor rates for the vascular
interventional technologist (L041A), mammography technologist (L043A),
and CT technologist (L046A) in CY 2023. The commenters stated that the
education requirements for a cytotechnologist were greater than the
requirements for these clinical labor types and that the
cytotechnologist should be valued 10 percent more than the CT
technologist based on Salary Expert data. Commenters stated that
cytotechnologists are responsible for more intensive clinical
responsibilities than MRI technologists, such as preparing and
evaluating human cellular samples from all body sites, to detect and
highlight for the pathologist's attention cells with pre-cancerous
changes, cancer cells, benign tumors, infectious agents, and
inflammatory processes. Commenters requested that CMS crosswalk the
cytotechnologist clinical labor type to the BLS 29-9092 category
(genetic counselors) at a rate of $0.85 to correct this pricing anomaly
and supported their request with data from the 2021 American Society of
Clinical Pathologists (ASCP) Wage Survey of Medical Laboratories, in
which the average cost per minute for cytotechnologists was $0.86.
Response: We appreciate the additional information surrounding the
cytotechnologist (L045A) clinical labor type supplied by the
commenters, especially the 2021 ASCP wage survey containing wage data
on this clinical labor type. After reviewing the information submitted
by the commenters, we concur that a crosswalk to the BLS 29-9092
category at a rate of $0.85 would be more accurate for the L045A
clinical labor type, based on the wage data provided by Salary Expert
and the 2021 ASCP wage survey. We are finalizing this update in the
clinical labor pricing of the L045A clinical labor type from $0.76 to
$0.85 based on this new information.
Comment: Several commenters expressed their disagreement with the
ongoing clinical labor pricing update. Commenters stated that the
pricing update continued to apply a huge and unfair burden on
specialties that require expensive supplies and/or equipment to care
for their patients, and that while the increase in clinical labor
pricing was appropriate, it was not appropriate that some physicians
were negatively impacted by the change. Commenters stated that these
dramatic cuts will also further exacerbate disparities in access to
care and health outcomes, among rural and minority populations, by
constraining and in some cases preventing physicians in community-based
office settings from providing critical patient care to underserved
populations. Commenters asked CMS to hold harmless the specialties that
were most affected by the clinical labor pricing update and not move
forward with the third 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 implementation of the clinical labor
pricing update 2 years ago in the CY 2022 PFS final rule (86 FR 65020
through 65037) where we previously addressed these same comments. As we
stated at that time, although we recognize that payment for some
services will be reduced because of the pricing update, due to the
budget neutrality 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. 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 2 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.
For CY 2024, we solicited comments regarding new wage data or other
additional information for use in clinical labor pricing from
interested parties. The clinical labor pricing update itself, including
its pricing methodology, was previously finalized through rulemaking
and the first 2 years of the 4-year transition have already been
implemented; as such, these comments are out of scope for CY 2024
rulemaking.
After consideration of the comments, we are finalizing the clinical
labor prices as shown in Table 7; aside from the Cytotechnologist
(L045A) clinical labor type detailed above, all other clinical labor
pricing remains unchanged from the proposed rule.
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[[Page 78840]]
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BILLING CODE 4120-01-C
As was the case for the market-based supply and equipment pricing
update, the clinical labor rates will remain open for public comment
over the remaining course of the 4-year transition period. We welcome
additional feedback on clinical labor pricing from commenters in next
year's rulemaking cycle, especially any data that will continue to
improve the accuracy of our finalized pricing.
d. Technical Corrections to Direct PE Input Database and Supporting
Files
Following the publication of the CY 2023 PFS proposed rule, an
interested party notified CMS that CPT code 86153 (Cell enumeration
using immunologic selection and identification in fluid specimen (e.g.,
circulating tumor cells in blood); physician interpretation and report,
when required) appeared to be missing its work time in the Physician
Work Time public use file. We reviewed the request from the interested
party and determined that this was indeed an unintended technical
error; we stated in the CY 2013 PFS final rule that we were finalizing
0 minutes pre-service time, 20 minutes intraservice time, and 0 minutes
post-service time to CPT code 86153 (77 FR 69059); however, work time
was inadvertently completely missing for this code. Therefore, we
proposed to add the correct 20 minutes of intraservice work time to CPT
code 86153 for CY 2024.
Comment: A commenter stated that they agreed with the correction of
this error and urged CMS to finalize the update of 20 minutes of intra
service work time for CPT code 86153.
Response: We appreciate the support for our proposal from the
commenter. We received no other comments regarding this proposal, and
we are finalizing the addition of the correct 20 minutes of
intraservice work time to CPT code 86153 for CY 2024, as proposed.
We received the following comments on technical corrections to the
direct PE input database and supporting files:
Comment: A commenter stated that transcatheter valve procedures are
extremely technical in nature and require a highly functional multi-
disciplinary surgical and operating room team, which was not reflected
in the indicators currently assigned to certain Category III codes
associated with this service. The commenter stated that these Category
III codes should have their assistant surgeon, co-surgeon, and team
surgeon indicators match CPT codes 33418 and 33419. Specifically, the
commenter requested that CMS change the assistant surgeon payment
policy indicator from ``0'' to ``2'' for the following transcatheter
valve CPT codes: 0483T, 0544T, 0545T, 0569T, 0570T and 0646T; change
the co-surgeon payment policy indicator from ``0'' to ``1'' for
transcatheter valve CPT codes 0544T, 0545T, 0569T and 0570T, and to
``2'' for CPT code 0646T; and change the team surgeon payment policy
indicator from ``0'' to ``1'' for CPT code 0646T.
Response: We appreciate the feedback from the commenter regarding
the need for greater consistency in the indicators for these Category
III transcatheter valve procedures. After reviewing the request from
the commenter, we concur that these Category III codes should match the
assistant surgeon, co-surgeon, and team surgeon indicators for CPT
codes 33418 and 33419 which had a national coverage determination
released to this effect in 2014 and 2015 (see https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/MM9002.pdf).
Therefore, we are finalizing the indicator changes requested by the
commenter in the previous paragraph.
Comment: Several commenters raised the topic of indirect PE
allocation for the home PT/INR monitoring services described by HCPCS
codes G0248 and G0249. Commenters stated their appreciation that CMS
acknowledged their concerns about the lack of a specialty designation
that accurately reflects the indirect costs of home PT/INR monitoring
suppliers in the CY 2021 PFS rulemaking cycle and agreed to update the
indirect factors for home PT/INR monitoring by crosswalking to the
General Practice Specialty (85 FR 84477 through 84478). Commenters
stated that proposed policies in the CY 2023 PFS rule completely
negated the limited benefit from this crosswalk to General Practice,
and they again appreciated that CMS changed the crosswalk for PT/INR
suppliers to the All Physician specialty which more closely reflected
indirect-to-direct cost ratios for home PT/INR monitoring services (87
FR 69417 through 69419). Commenters noted that CMS did not propose any
changes in the crosswalk for these services and requested that the
crosswalk remain as previously finalized for CY 2024.
Response: As the commenters noted, we did not propose any changes
to the specialty crosswalk for indirect PE allocation for home PT/INR
monitoring services and we are not finalizing any changes to the
crosswalk for PT/INR monitoring services. Nevertheless, we appreciate
the support from the commenters for our previously finalized policies.
Comment: A commenter questioned the proposed PE RVU for CPT code
97610 (Low frequency, non-contact, non-thermal ultrasound, including
topical application(s), when performed, wound assessment, and
instruction(s) for ongoing care, per day) in the nonfacility setting.
The commenter stated that the proposed reduction was an unfair decrease
that was specific only to CPT code 97610 when other clinically similar
CPT wound care codes were not similarly reduced. The commenter
requested that the nonfacility PE RVU for CPT code 97610 be reviewed
for accuracy and increased
[[Page 78841]]
to match its previous valuation for CY 2024.
Response: We reviewed CPT code 97610 in response to the commenter's
concerns and we can confirm that there are no technical errors
affecting the valuation of this code. We did not make any specific
proposals regarding CPT code 97610 for CY 2024; however, the valuation
for this code is being affected by the ongoing clinical labor pricing
transition. Supply costs make up 94.5 percent of the direct PE inputs
for CPT code 97610 and, as a result, the increased pricing for clinical
labor across all services on the PFS translates into a lower valuation
for CPT code 97610, after budget neutrality is applied to the PE. For
additional information on this topic, we direct readers to the extended
discussion of the clinical labor pricing update in the CY 2022 final
rule (86 FR 65020 through 65037).
Comment: A commenter stated that StrategyGen's market-based supply
and equipment research contained numerous flaws in how it arrived at
the cost of the external counterpulsation (ECP) system (EQ012) used in
HCPCS code G0166 (External counterpulsation, per treatment session) for
CY 2021. The commenter stated that they appreciated CMS' assistance in
recent years to correct some of these errors, but the continued phase-
in of PE RVU decreases associated with equipment costs, as well as the
clinical labor pricing updates adversely impacting services with high
capital expenses, continued to place incredible stress on the
reimbursement for ECP therapy. The commenter stated that the
reimbursement for a full course of therapy has decreased from 2018 to
2023 by nearly the cost of the routinely purchased supplies necessary
for delivering this service, and as a result it is no surprise that
practices that do not specialize in ECP therapy would rather abandon
the service than continue to pay the expensive system maintenance
costs.
Response: We note for the commenter that we did not make any
proposals specifically regarding HCPCS code G0166 or the EQ012
equipment for CY 2024 and the commenter did not supply invoices or
other data to support a change in pricing. If the commenter has reason
to believe that the EQ012 equipment is inaccurately priced, interested
parties are encouraged to submit invoices containing pricing data with
their public comments or, if outside the notice and comment rulemaking
process, via email at [email protected]. If the
commenter believes that HCPCS code G0166 may be potentially misvalued,
we encourage them to consider nominating the code under our potentially
misvalued process (detailed in section II.C. of this final rule) for
additional review.
5. Soliciting Public Comment on Strategies for Updates to Practice
Expense Data Collection and Methodology
a. Background
The AMA PPIS was first introduced in 2007 as a means to collect
comprehensive and reliable data on the direct and indirect PEs incurred
by physicians (72 FR 66222). In considering the use of PPIS data, the
goal was to improve the accuracy and consistency of PE RVUs used in the
PFS. The data collection process included a stratified random sample of
physicians across various specialties, and the survey was administered
between August 2007 and March 2008. Data points from that period of
time are integrated into PFS calculations today. In the CY 2009 PFS
proposed rule (73 FR 38507 through 3850), we discussed the indirect PE
methodology that used data from the AMA's survey that predated the
PPIS. In CY 2010 PFS rulemaking, we announced our intent to incorporate
the AMA PPIS data into the PFS ratesetting process, which would first
affect the PE RVU. In the CY 2010 PFS proposed rule, we outlined a 4-
year transition period, during which we would phase in the AMA PPIS
data, replacing the existing PE data sources (74 FR 33554). We also
explained that our proposals intended to update survey data only (74 FR
33530 through 33531). In our CY 2010 final rule, we finalized our
proposal, with minor adjustments based on public comments (74 FR 61749
through 61750). We responded to the comments we received about the
transition to using the PPIS to inform indirect PE allocations (74 FR
61750). In the responses, we acknowledged concerns about potential gaps
in the data, which could impact the allocation of indirect PE for
certain physician specialties and suppliers, which are issues that
remain important today. The CY 2010 PFS final rule explains that
section 212 of the Balanced Budget Refinement Act of 1999 (BBRA) (Pub.
L. 106-113, November 29, 1999) directed the Secretary to establish a
process under which we accept and use, to the maximum extent
practicable and consistent with sound data practices, data collected or
developed by entities and organizations to supplement the data we
normally collect in determining the PE component. BBRA required us to
establish criteria for accepting supplemental survey data. Since the
supplemental surveys were specific to individual specialties and not
part of a comprehensive multispecialty survey, we had required that
certain precision levels be met in order to ensure that the
supplemental data was sufficiently valid, and acceptable for use in the
development of the PE RVUs. At the time, our rationale included the
assumption that because the PPIS is a contemporaneous, consistently
collected, and comprehensive multispecialty survey, we do not believe
similar precision requirements are necessary, and we did not propose to
establish them for the use of the PPIS data (74 FR 61742). We noted
potential gaps in the data, which could impact the allocation of
indirect PE for certain physician and suppliers. The CY 2010 final rule
adopted the proposal, with minor adjustments based on public comments,
and explained that these minor adjustments were in part due to non-
response bias that results when the characteristics of survey
respondents differ in meaningful ways, such as in the mix of practices
sizes, from the general population (74 FR 61749 through 61750).
Throughout the 4-year transition period, from CY 2010 to CY 2013,
we gradually incorporated the AMA PPIS data into the PFS rates,
replacing the previous data sources. The process involved addressing
concerns and making adjustments as necessary, such as refining the PFS
ratesetting methodology in consideration of interested party feedback.
For background on the refinements that we considered after the
transition began, we refer readers to discussions in the CY 2011
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
[[Page 78842]]
73033 through 73034). We indicated that CMS would continue to review
and refine the methodology and work with interested parties to address
their concerns. In the CY PFS 2014 final rule, we responded to comments
about fully implementing the AMA PPIS data. By 2014, the AMA PPIS data
had been fully integrated into the PFS, serving as the primary source
for determining indirect PE inputs (78 FR 74235). We continued to
review data and the PE methodology annually, considering interested
party feedback and evaluating the need for updates or refinements to
ensure the accuracy and relevance of PE RVUs (79 FR 67548). In the
years following the full implementation of the AMA PPIS data, we
further engaged with interested parties, thought leaders and subject
matter experts to improve our PE inputs' accuracy and reliability. For
further background, we refer readers to our discussions in final rules
for CY 2016 through 2022 (80 FR 70892; 81 FR 80175; 82 FR 52980 through
52981; 83 FR 59455 through 59456; 84 FR 62572; 85 FR 84476 through
84478; 86 FR 62572).
In our CY 2023 PFS final rule, we issued an RFI to solicit public
comment 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 last year's rule, we have continued interest in
developing a roadmap for updates to our PE methodology that account for
changes in the health care landscape. Of various considerations
necessary to form a roadmap for updates, we reiterate that allocations
of indirect PE continue to present a wide range of challenges and
opportunities. As discussed in multiple cycles of previous rulemaking,
our PE methodology relies on AMA PPIS data, which may represent the
best aggregated available source of information at this time. However,
we acknowledge the limitations and challenges interested parties have
raised about using the current data for indirect PE allocations, which
we have also examined in related ongoing research. We noted in last
year's rule that there are several competing concerns that CMS must
take into account when considering updated data sources, which also
should support and enable ongoing refinements to our PE methodology.
Many commenters last year asked that CMS wait for the AMA to
complete a refresh of AMA survey data. We responded to these comments
by explaining the tension that waiting creates in light of concerns
raised by other interested parties. Waiting for refreshed survey data
would result in CMS using data nearly 20 years old to form indirect PE
inputs to set rates for services on the PFS. We reminded readers that
many of the critical issues discussed in the background and history
above are mainly unchanged and possibly would not be addressed by an
updated survey alone but may also require revisions to the PFS
ratesetting methodology.
b. Summary of the Comments and Responses for the Request for
Information
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. We stated that submissions should
discuss the feasibility and burden of implementing any suggested
adjustments and highlight opportunities to optimize the cadence,
frequency, and phase-in of resulting adjustments. We stated that we
were continuing to consider ways that we may engage in dialogue with
interested parties to better understand how to address possible long-
term policies and methods for PFS ratesetting. We believe some of those
concerns may be alleviated by having ways to refresh data and make
transparent how the information affects valuations for services payable
under the PFS more accurately and precisely.
Considering our ratesetting methodology and prior experiences
implementing new data, we issued a follow-up 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 light of the considerations discussed above, we requested
feedback on the following:
(1) If CMS should consider aggregating data for certain physician
specialties to generate indirect allocators so that PE/HR calculations
based on PPIS data would be less likely to over-allocate (or under-
allocate) indirect PE to a given set of services, specialties, or
practice types. Further, what thresholds or methodological approaches
could be employed to establish such aggregations?
(2) Whether aggregations of services, for purposes of assigning PE
inputs, represent a fair, stable and accurate means to account for
indirect PEs across various specialties or practice types?
(3) If and how CMS should balance factors that influence indirect
PE inputs when these factors are likely driven by a difference in
geographic location or setting of care, specific to individual
practitioners (or practitioner types) versus other specialty/practice-
specific characteristics (for example, practice size, patient
population served)?
(4) What possible unintended consequences may result if CMS were to
act upon the respondents' recommendations for any of highlighted
considerations above?
(5) Whether specific types of outliers or non-response bias may
require different analytical approaches and methodological adjustments
to integrate refreshed data?
We received public comments on this RFI. The following is a summary
of the comments we received and our responses.
Comment: Most commenters stated that CMS should defer significant
changes until the AMA PPIS results become available. 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 responds to all five prompts in the RFI with
rationales that support the assertion that CMS should not consider
further changes until PPIS data collection and analysis is complete.
[[Page 78843]]
Response: We thank the AMA RUC for commenting. In totality, the AMA
comments generally do not support any change to the methodology and
assert that CMS should wait to consider any further changes until PPIS
updates become available. Further, we note 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.\1\ 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.
---------------------------------------------------------------------------
\1\ Refer to the AMA's summary of the PPIS, available at https://www.ama-assn.org/system/files/physician-practice-information-survey-summary.pdf.
---------------------------------------------------------------------------
Comment: Some commenters did not recommend that CMS defer
significant changes until the AMA PPIS results become available. These
commenters stated that reliance on the PPIS updates may not improve the
accuracy and stability of the PE methodology because of the survey
design, possible implementation challenges, and a possible lack of
transparency or granularity in resulting datasets.
Response: We thank commenters for their feedback. 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 last year's RFI in the CY 2023
final rule (refer to 87 FR 69429 through 69432). In last year's RFI, we
signaled our intent to move to a standardized and routine approach to
valuation of PE and we solicited feedback. We solicited comment on the
appropriate instrument, methods, and timing for updating PE data, and
requested information on any alternatives that would result in more
predictable results, increased efficiencies, or reduced burdens, for
subsequent updates in later years CMS continues to seek alternatives
that use verifiable, more objective data sets in the future to
supplement or augment survey data used to establish PE RVUs for PFS
services.
Comment: Some commenters stated that regardless of whether one
supports or does not support updating and using updated PPIS data, the
duration between updates and the expense of fielding a survey
instrument may promote further market consolidation. Additionally,
other commenters stated that dependence on the PPIS or survey data in
general, due to timing and frequency constraints, may continue to
jeopardize independent practice and discourage fair competition among
suppliers and providers of services paid under the PFS. These
commenters assert that if current trends continue, it will result in
far fewer independent practices and more consolidation before the
availability of updated survey data, undermining the sampling
methodology of any survey and the general goals of our PE methodology
updates.
Response: We thank commenters for their feedback, and we encourage
interested parties to continue to engage with us regarding the
intersection of PE data and these important issues
Comment: We received a comment co-signed by a broad and varied set
of interested parties (for example, professional membership
organizations, vendors, practitioners, health systems) that requested a
separate RFI. The authors asked that CMS address topics regarding
machine learning, AI, and software and explore a means outside our
annual rulemaking cycle, so that CMS may address changes in healthcare
related to these topics and better account for such changes in payment
moving forward. Commenters asserted that the rapid pace of innovation
may require far more significant changes than would be practical to
address in a given calendar year. The commenters also highlighted the
AMA's efforts to develop Appendix S of the CPT Manual, which
establishes a taxonomy for medical AI.
Response: We remain committed to fostering dialogue with interested
parties on a variety of PE issues, including how to most appropriately
incorporate new and evolving technologies in both collection of PE data
and the PE methodology itself. Further, we acknowledge the efforts of
the AMA to establish a taxonomy for AI, which was informed by
engagement with HHS ONC and others (refer to https://www.healthit.gov/sites/default/files/page/2020-02/GettingerModeratorSlidesAIPanelsforONCAnnualMeeting12720Final.pdf). We
encourage readers to review general resources that provide overviews of
efforts across HHS that address these topics. Examples include ONC's AI
Showcase, held in late 2022, available at https://www.healthit.gov/news/events/onc-artificial-intelligence-showcase-seizing-opportunities-and-managing-risks-use-ai and this year's issuance of a notice of
proposed rulemaking for Health Data, Technology, and Interoperability:
Certification Program Updates, Algorithm Transparency, and Information
Sharing (HTI-1), (88 FR 23746); as well as the FDA's Artificial
Intelligence/Machine Learning (AI/ML)-Based Software as a Medical
Device (SaMD) Action Plan, available at https://www.fda.gov/media/145022/download and Good Machine Learning Practice for Medical Device
Development: Guiding Principles, available at https://www.fda.gov/medical-devices/software-medical-device-samd/good-machine-learning-practice-medical-device-development-guiding-principles.
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 discussed 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 (RVS)
Update Committee (RUC), MedPAC, and other interested parties. For many
years, the RUC has provided us with recommendations on the appropriate
relative values for new, revised, and potentially misvalued PFS
services. We review these recommendations on a code-by-code basis and
consider these recommendations in conjunction with analyses of other
data, such as claims data, to inform the decision-making process as
authorized by statute. We may also consider analyses of work time, work
RVUs, or direct PE inputs using other data sources, such as Department
of Veteran Affairs (VA), National Surgical Quality Improvement Program
(NSQIP), the Society for Thoracic Surgeons (STS), and the Merit-based
Incentive Payment System (MIPS) data. In addition to considering the
most recently available data, we assess the results of physician
surveys and
[[Page 78844]]
specialty recommendations submitted to us by the RUC for our review. We
also considered information provided by other interested parties such
as from the general medical-related community and the public. We
conducted a review to assess the appropriate RVUs in the context of
contemporary medical practice. We note that section 1848(c)(2)(A)(ii)
of the Act authorizes the use of extrapolation and other techniques to
determine the RVUs for physicians' services for which specific data are
not available and requires us to take into account the results of
consultations with organizations representing physicians who provide
the services. In accordance with section 1848(c) of the Act, we
determine and make appropriate adjustments to the RVUs.
In its March 2006 Report to the Congress (http://www.medpac.gov/docs/default-source/reports/Mar06_Ch03.pdf?sfvrsn=0), MedPAC discussed
the importance of appropriately valuing physicians' services, noting
that misvalued services can distort the market for physicians'
services, as well as for other health care services that physicians
order, such as hospital services. In that same report, MedPAC
postulated that physicians' services under the PFS can become misvalued
over time. MedPAC stated, ``When a new service is added to the
physician fee schedule, it may be assigned a relatively high value
because of the time, technical skill, and psychological stress that are
often required to furnish that service. Over time, the work required
for certain services would be expected to decline as physicians become
more familiar with the service and more efficient in furnishing it.''
We believe services can also become overvalued when PE costs decline.
This can happen when the costs of equipment and supplies fall, or when
equipment is used more frequently than is estimated in the PE
methodology, reducing its cost per use. Likewise, services can become
undervalued when physician work increases or PE costs rise.
As MedPAC noted in its March 2009 Report to Congress (http://www.medpac.gov/docs/default-source/reports/march-2009-report-to-congress-medicare-payment-policy.pdf), in the intervening years since
MedPAC made the initial recommendations, CMS and the RUC have taken
several steps to improve the review process. Also, section
1848(c)(2)(K)(ii) of the Act augments our efforts by directing the
Secretary to specifically examine, as determined appropriate,
potentially misvalued services in the following categories:
Codes that have experienced the fastest growth.
Codes that have experienced substantial changes in PE.
Codes that describe new technologies or services within an
appropriate time-period (such as 3 years) after the relative values are
initially established for such codes.
Codes which are multiple codes that are frequently billed in
conjunction with furnishing a single service.
Codes with low relative values, particularly those that are
often billed multiple times for a single treatment.
Codes that have not been subject to review since
implementation of the fee schedule.
Codes that account for the majority of spending under the PFS.
Codes for services that have experienced a substantial change
in the hospital length of stay or procedure time.
Codes for which there may be a change in the typical site of
service since the code was last valued.
Codes for which there is a significant difference in payment
for the same service between different sites of service.
Codes for which there may be anomalies in relative values
within a family of codes.
Codes for services where there may be efficiencies when a
service is furnished at the same time as other services.
Codes with high intraservice work per unit of time.
Codes with high PE RVUs.
Codes with high cost supplies.
Codes as determined appropriate by the Secretary.
Section 1848(c)(2)(K)(iii) of the Act also specifies that the
Secretary may use existing processes to receive recommendations on the
review and appropriate adjustment of potentially misvalued services. In
addition, the Secretary may conduct surveys, other data collection
activities, studies, or other analyses, as the Secretary determines to
be appropriate, to facilitate the review and appropriate adjustment of
potentially misvalued services. This section also authorizes the use of
analytic contractors to identify and analyze potentially misvalued
codes, conduct surveys or collect data, and make recommendations on the
review and appropriate adjustment of potentially misvalued services.
Additionally, this section provides that the Secretary may coordinate
the review and adjustment of any RVU with the periodic review described
in section 1848(c)(2)(B) of the Act. Section 1848(c)(2)(K)(iii)(V) of
the Act specifies that the Secretary may make appropriate coding
revisions (including using existing processes for consideration of
coding changes) that may include consolidation of individual services
into bundled codes for payment under the PFS.
2. Progress in Identifying and Reviewing Potentially Misvalued Codes
To fulfill our statutory mandate, we have identified and reviewed
numerous potentially misvalued codes as specified in section
1848(c)(2)(K)(ii) of the Act, and we intend to continue our work
examining potentially misvalued codes in these areas over the upcoming
years. As part of our current process, we identify potentially
misvalued codes for review, and request recommendations from the RUC
and other public commenters on revised work RVUs and direct PE inputs
for those codes. The RUC, through its own processes, also identifies
potentially misvalued codes for review. Through our public nomination
process for potentially misvalued codes established in the CY 2012 PFS
final rule with comment period (76 FR 73026, 73058 through 73059),
other individuals and groups submit nominations for review of
potentially misvalued codes as well. Individuals and groups may submit
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
[[Page 78845]]
discussion of the extensive prior reviews of potentially misvalued
codes is included in the CY 2012 PFS final rule with comment period (76
FR 73052 through 73055). In the same CY 2012 PFS final rule with
comment period, we finalized our policy to consolidate the review of
physician work and PE at the same time, and established a process for
the annual public nomination of potentially misvalued services.
In the CY 2013 PFS final rule with comment period (77 FR 68892,
68896 through 68897), we built upon the work we began in CY 2009 to
review potentially misvalued codes that have not been reviewed since
the implementation of the PFS (so-called ``Harvard-valued codes'' \2\).
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.
---------------------------------------------------------------------------
\2\ The research team and panels of experts at the Harvard
School of Public Health developed the original work RVUs for most
CPT codes, in a cooperative agreement with the Department of Health
and Human Services (HHS). Experts from both inside and outside the
Federal Government obtained input from numerous physician specialty
groups. This input was incorporated into the initial PFS, which was
implemented on January 1, 1992.
---------------------------------------------------------------------------
3. CY 2024 Identification and Review of Potentially Misvalued Services
In the CY 2012 PFS final rule with comment period (76 FR 73058), we
finalized a process for the public to nominate potentially misvalued
codes. In the CY 2015 PFS final rule with comment period (79 FR 67548,
67606 through 67608), we modified this process whereby the public and
interested parties may nominate potentially misvalued codes for review
by submitting the code with supporting documentation by February 10th
of each year. Supporting documentation for codes nominated for the
annual review of potentially misvalued codes may include the following:
Documentation in peer reviewed medical literature or other
reliable data that demonstrate changes in physician work due to one or
more of the following: technique, knowledge and technology, patient
population, site-of-service, length of hospital stay, and work time.
An anomalous relationship between the code being proposed
for review and other codes.
Evidence that technology has changed physician work.
Analysis of other data on time and effort measures, such
as operating room logs or national and other representative databases.
Evidence that incorrect assumptions were made in the
previous valuation of the service, such as a misleading vignette,
survey, or flawed crosswalk assumptions in a previous evaluation.
Prices for certain high cost supplies or other direct PE
inputs that are used to determine PE RVUs are inaccurate and do not
reflect current information.
Analyses of work time, work RVU, or direct PE inputs using
other data sources (for example, VA, NSQIP, the STS National Database,
and the MIPS data).
National surveys of work time and intensity from
professional and management societies and organizations, such as
hospital associations.
We evaluate the supporting documentation submitted with the
nominated codes and assess whether the nominated codes appear to be
potentially misvalued codes appropriate for review under the annual
process. In the following year's PFS proposed rule, we publish the list
of nominated codes and indicate for each nominated code whether we
agree with its inclusion as a potentially misvalued code. The public
has the opportunity to comment on these and all other proposed
potentially misvalued codes. In each year's final rule, we finalize our
list of potentially misvalued codes.
a. Public Nominations
In each proposed rule, we seek nominations from the public and from
interested parties of codes that they believe we should consider as
potentially misvalued. We receive public nominations for potentially
misvalued codes by February 10th and we display these nominations on
our public website, where we include the submitter's name and their
associated organization for full transparency. We sometimes receive
submissions for specific, PE-related inputs for codes, and discuss
these PE-related submissions, as necessary under the Determination of
PE RVUs section of the rule. We summarize below this year's submissions
under the potentially misvalued code initiative. For CY 2024, we
received 10 nominations concerning various codes. The nominations are
as follows:
(1) CPT Code 59200
In the CY 2022 PFS proposed rule, an interested party nominated CPT
code 59200 (Insertion cervical dilator (e.g., laminaria,
prostaglandin)) (000 zero day global code) as potentially misvalued,
because the direct PE inputs for this code do not include the supply
item, Dilapan-S. Previous parties had initially sought to establish a
Level II HCPCS code for Dilapan-S, but CMS did not find sufficient
evidence to support that request. The same interested party then
submitted Dilapan-S to be considered as a practice expense (PE) supply
input to a Level I CPT code 59200 (86 FR 65045). This year, a different
interested party nominated CPT code 59200 again, and provided the same
reasoning as to why this code is potentially misvalued.
Specifically, the current nominee recommended adding 4 rods of
Dilapan-S at $80.00 per unit, for a total of $320.00 to this one PE
supply inputs, as a replacement for the current PE supply item--
laminaria tent (a small rod of dehydrated seaweed that rehydrates,
absorbing the water from the surrounding tissue). The laminaria tent is
currently listed at $4.0683 per unit, with a total of 3 units, for a
total of $12.20. The current nominee stated that Dilapan-S is more
consistent and reliable, and suggested that it had higher patient
satisfaction than the laminaria tent, and that it was less likely to
cause leukocytosis. CPT code 59200 is a relatively low volume code,
with respect to Medicare claims and, as the nominator stated, this
service is more typically billed for the Medicaid population, as
evidenced by 1.3 million Medicaid claims for this service. Medicaid
programs are able to set their own payment policies, which can be
different from Medicare payment policies. The current Medicare payment
for CPT code 59200 in CY 2023 is about $108.10 in the nonfacility/
office setting, which is much less than the typical cost of the
Dilapan-S supplies requested by the interested party. The requested 4
rods of Dilapan-S would increase the
[[Page 78846]]
supply costs of CPT code 59200 by a factor of five and represent an
enormous increase in the direct costs for the service.
We did not agree that CPT code 59200 was potentially misvalued, and
we did not agree with interested parties that the use of the Dilapan-S
supply would be typical for the service. By including the increased
direct costs of the service ($320.00, the typical cost of four units of
this supply item, Dilapan-S) in the valuation for this code, the cost
of this service would expand both Medicare spending and cost sharing
for any beneficiary who received this service. The cost of Dilapan-S is
over 19 times higher than the cost of the current supply item
(laminaria tent) for CPT code 59200. We agreed with the nominator that
CPT code 59200 was more frequently reported in the Medicaid population,
and therefore, we suggested that interested parties submit a request
for new and separate Medicaid payments to Medicaid.
While we did not propose to consider CPT code 59200 as potentially
misvalued for CY 2024, we solicited comments on this code.
Specifically, we asked commenters whether the absence of supply item
Dilapan-S makes the nonfacility/office Medicare payment for this code
potentially misvalued.
We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: Several commenters suggested replacing the laminaria tent
supply item with Dilapan-S, both of which are used to dilate the cervix
in preparation for the induction of labor. Commenters stated that the
code and supply input pricing for CPT code 59200 are both outdated
since the service has evolved and the prices for its PE and supply
items have increased since the code was last reviewed in 2003. One
commenter noted that the use of the laminaria tent instead of Dilapan-S
is not typical of, and does not reflect the standard of care for, term
induction of labor; and that there are now many methods of cervical
dilation, including pharmacological, mechanical, and surgical.
Also, commenters noted that CPT code 59200 only describes the
insertion of the cervical dilator using the laminaria and/or
prostaglandins and it does not describe the insertion of the cervical
dilator with other practice expense supply items. As a result,
commenters suggested CPT code 59200 should be reviewed.
Response: We thank commenters for pointing out that CPT code 59200
is a specific procedure for cervical dilation and that other methods of
cervical dilation (pharmacological, mechanical, and surgical) have come
into practice that are not described by CPT code 59200. We also
appreciate commenters' pointing out that the current market price of
the laminaria tent has increased since the supply item price was
established in 2003. Lastly, we acknowledge commenters' suggestion
regarding the replacement of the supply item laminaria tent with
Dilapan-S.
Comment: A number of commenters stated that CPT code 59200
performed in the office or in the outpatient setting is more efficient
in many ways (including in overall costs) and helps in inducing labor,
which in turn, helps promotes vaginal births rather than concluding as
Cesarean sections when there is not enough dilation. The commenters
noted that in comparison, vaginal births obviously shorten hospital
stays and patient recoveries and improves patient satisfaction in the
birthing method.
Commenters noted that alternate cervical dilation such as
prostaglandins medication must be administered as inpatient, and
mechanical dilation is performed in an outpatient setting, but CPT code
59200 can typically be performed in the office, which is more
desirable. Physicians have noted that patient populations today tend to
have higher incidences of obesity, hypertension, diabetes, and
advancing maternal age complications and to ensure healthy births and
maintain the highest standards of care, the induction of labor is
necessary, which begins with CPT code 59200, cervical dilation. One
commenter adds that the use of laminaria instead of Dilapan-S is not
the standard of care for term induction of labor.
Response: After reviewing the comments concerning CPT code 59200,
we are mainly concerned with whether the code currently represents how
the medical procedure is performed today. We agree with commenters that
CPT code 59200 is a potentially misvalued service since the code has
not been reviewed in 20 years and the current typical practice of this
code has likely evolved since then, warranting a comprehensive review.
As such, we believe that CPT code 59200 could benefit from a review of
its supply, equipment, and clinical labor items, plus physician work
RVUs and physician work times. Therefore, based on the information
provided by commenters regarding the outdated nature of the code and
supply input pricing, we are finalizing CPT code 59200 as potentially
misvalued for CY 2024.
(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) was nominated as potentially
misvalued due to the absence of separate direct PE inputs for this 090
day global code in the nonfacility office setting. Currently, the PFS
only prices CPT code 27279 in the facility setting, at about $826.85
for the physician's professional services, but the nominators were
seeking separate direct PE inputs for this service to better account
for valuation when performed in the nonfacility/office setting.
The nominator claimed that CPT code 27279 could be safely and
effectively furnished in the nonfacility setting and that this
procedure has a low-risk profile, similar to kyphoplasty (CPT codes
22513, 22514, and 22515), which is currently furnished in the
nonfacility setting. The nominator described Kyphoplasty as ``a
percutaneous minimally invasive procedure depositing poly methyl
methacrylate via a cannula into vertebral bodies near neural
structures.'' The nominator stated that permitting payment for direct
PE inputs for CPT code 27279 in the nonfacility/office setting would
increase access to this service for Medicare patients. The nominator
also submitted one sample invoice for $17,985.00 with three units of
the itemized supply item IFuse-3D Implant 7.0 mm x 55mm, US ($5,995.00
per unit) to illustrate the high direct PE costs for CPT code 27279,
should CMS value this code in the nonfacility/office setting.
We expressed concern about whether this 090-day surgical service
could be safely and effectively furnished in the non-facility/office
setting (for example, in an office-based surgical suite). We welcomed
comments on the nomination of CPT code 27279 for consideration as
potentially misvalued.
The following is a summary of the comments we received and our
responses.
Comment: Several commenters supported establishing a nonfacility/
office payment for CPT code 27279. Commenters stated that while the
procedure is currently performed in ASCs, it can be equally effective,
with minimal risk, when done in an office setting. Commenters also
stated that the fact that the service is assigned a 090-day global
period does not imply that the code should only be performed in an
inpatient setting nor that the service
[[Page 78847]]
carries a heightened level of risk, since CPT code 27279 is minimally
invasive. Additionally, to support their recommendation to create a
nonfacility/office payment for CPT code 27279, the commenters cited the
dorsal arthrodesis procedure (Dorsal Sacroiliac Joint Arthrodesis CPT
code 27278 (2X000)) for comparison since it also has a 090 global
period and a nonfacility-office payment.
Response: We appreciate the comments in support of establishing a
nonfacility/office payment for CPT code 27279.
Comment: Several commenters opposed creating a nonfacility/office
payment for CPT code 27279 due to patient safety concerns when
performed in the office setting. Also, some commenters noted that while
the kyphoplasty codes (CPT codes 22513, 22514, 22515) are often cited
as an example of codes supporting nonfacility/office payments similar
to CPT code 27279, those codes have 010 day global periods and do not
have the same level of risk as CPT code 27279. Commenters supported
this point by stating that CPT code 27279 is not necessarily minimally
invasive because it requires the incision and collection of bone as
well as the placement of titanium implants across the sacroiliac joint.
Response: We appreciate the comments opposing the establishment of
a nonfacility/office payment for CPT code 27279.
We thank the commenters for the multiple perspectives regarding
nonfacility/office payment for these services. We note that there does
not appear to be a consensus on whether these services may be safely
and effectively furnished in the nonfacility/office setting, which is a
primary concern in our policy consideration. Therefore, for CY 2024, we
are not finalizing CPT code 27279 as potentially misvalued.
However, after reviewing the public comments, we note a growing
number of potentially misvalued code nominations requesting that we
establish nonfacility payment rates where there currently are none. We
acknowledge that the practice of medicine continues to evolve in ways
that, in clinically appropriate and effective circumstances, there may
be support for a transition of complex procedures into ambulatory
settings. We also acknowledge that PE inputs for such services should
be appropriately determined and established to appropriately reflect
typical clinical practice. We believe services such as those described
by the nominator would benefit from review by other interested parties,
such as the AMA RUC and private payors, even as we consider our
policies for such services.
We look forward to considering valuation recommendations for such
services and additional information that may inform our payment policy
considerations in future rulemaking.
(3) CPT Codes 99221, 99222, and 99223
An interested party nominated the Hospital Inpatient and
Observation Care visit CPT codes 99221 (Initial hospital care, per day,
for the evaluation and management of a patient, which requires these 3
key components: A detailed or comprehensive history; A detailed or
comprehensive examination; and Medical decision making that is
straightforward or of low complexity. Counseling and/or coordination of
care with other physicians, other qualified health care professionals,
or agencies are provided consistent with the nature of the problem(s)
and the patient's and/or family's needs. Usually, the problem(s)
requiring admission are of low severity. Typically, 30 minutes are
spent at the bedside and on the patient's hospital floor or unit.),
99222 (Initial hospital care, per day, for the evaluation and
management of a patient, which requires these 3 key components: A
comprehensive history; A comprehensive examination; and Medical
decision making of moderate complexity. Counseling and/or coordination
of care with other physicians, other qualified health care
professionals, or agencies are provided consistent with the nature of
the problem(s) and the patient's and/or family's needs. Usually, the
problem(s) requiring admission are of moderate severity. Typically, 50
minutes are spent at the bedside and on the patient's hospital floor or
unit.), and 99223 (Initial hospital care, per day, for the evaluation
and management of a patient, which requires these 3 key components: A
comprehensive history; A comprehensive examination; and Medical
decision making of high complexity. Counseling and/or coordination of
care with other physicians, other qualified health care professionals,
or agencies are provided consistent with the nature of the problem(s)
and the patient's and/or family's needs. Usually, the problem(s)
requiring admission are of high severity. Typically, 70 minutes are
spent at the bedside and on the patient's hospital floor or unit.) as
potentially misvalued. We note that CMS reviewed these codes in the CY
2023 final rule (87 FR 69588) and established new physician work times
and new work RVU payments for these services. The nominator disagreed
with these values and asserted that these ``facility-based codes are
always inherently (or proportionately) more intense than E/M services
provided in other settings [in particular],'' with patients presenting
with potentially infectious diseases, such as meningitis; pneumonia;
tuberculosis; HIV/AIDS; Ebola virus; Zika virus; and, most recently,
SARS-CoV-2 and mpox, and that the inpatient setting has a predominance
of more seriously ill patients, who are sometimes immunocompromised
and/or have multiple drug interaction issues and/or with comorbidities,
making them extraordinarily more complex than those patients typically
found in the office setting (with many of these infections being
healthcare-associated infections and antibiotic-resistant bacterial
infections). We note that these new requests did not offer appreciably
new information relative to last year's nomination/consideration.
The nominator sought a new work RVU value of 1.92 for CPT code
99221, a new work RVU of 2.79 for CPT code 99222, and a new work RVU
value of 4.25 for CPT code 99223. Currently, CPT code 99221 has a work
RVU of 1.63, a reduction of 15.1 percent from its 1.92 work RVU from CY
2022. CPT code 99222 had a work RVU of 2.61 in CY 2022 and is now at
2.60. CPT code 99223 had a work RVU of 3.86 in CY 2022. It now has a
value of 3.50, which is a reduction of 9.3 percent. The nominator
requested that the work RVU for CPT code 99221 be restored back to
1.92, that the work RVU of CPT code 99222 be increased to 2.79, and
that the work RVU of CPT code 99223 be increased to 4.25 (please see
Table 8 for a comparison of work RVU values for CY 2022, CY 2023, and
of those requested by the nominator).
[[Page 78848]]
[GRAPHIC] [TIFF OMITTED] TR16NO23.010
After consideration of these nominations and their requests for
higher work RVUs for CPT codes 99221, 99222, and 99223, we proposed to
maintain the values that we finalized for these codes in the CY 2023
PFS final rule (87 FR 69588). Even so, we welcomed comments on the
nomination of these codes as potentially misvalued.
The following is a summary of the comments we received and our
responses.
Comment: Many commenters stated that CMS should not have accepted
the CY 2023 AMA RUC-recommended RVU values for CPT codes 99221, 99222,
and 99223 because they resulted in payment decreases for all three
services (partially due to a decrease in survey times), due to
significant flaws with the AMA RUC evaluation process. Several
commenters suggested that the work RVUs for CPT codes 99221, 99222, and
99223 be restored to their original values from before CY 2023 or be
increased to mimic the increases that the E/M family of codes has
experienced in recent years.
Response: We thank commenters for their feedback.
After consideration of public comments, we do not believe CPT codes
99221, 99222, and 99223 are potentially misvalued since they were
recently valued in the CY 2023 final rule (87 FR 69588). In that
regulation, we accepted the AMA RUC recommendations. We believe that
the AMA RUC recommendations are still appropriate and best reflect the
work intensity and time involved in furnishing these services.
Therefore, for CY 2024, we are not finalizing CPT codes 99221, 99222,
and 99223 as potentially misvalued.
(4) CPT Codes 36514, 36516, 36522
An interested party nominated CPT codes 36514 (Therapeutic
apheresis; for plasma pheresis), 36516 (Therapeutic apheresis; with
extracorporeal immunoadsorption, selective adsorption or selective
filtration and plasma reinfusion), and 36522 (Photopheresis,
extracorporeal) (all 000 day global codes) as potentially misvalued.
The interested party stated that the direct PE of clinical labor L042A,
``RN/LPN'' (for labor rate of $0.525 per minute), was incorrect and
should be changed to a more specific entry of ``a therapeutic apheresis
nurse specialist (RN)'' (for a labor rate of about $1.06 to $1.14 per
minute), which would approximately double all three of these codes'
clinical labor PE entries. In addition, the nominator disagreed with
the current direct PE of supply item SC085, ``Tubing set, plasma
exchange'' at $186.12 per item, and believed that this would be worth
$248.77 per item with CPT code 36514, using a quantity of one item. The
nominator believed that supply item SC084, ``Tubing set, blood
warmer,'' which we currently have listed at $8.01 per item, should be
worth $14.71 per item with CPT code 36514, also using a quantity of one
item. The nominator submitted sample invoices (not actual invoices) for
illustration and support. We welcomed comments on whether these codes
were potentially misvalued.
The following is a summary of the comments we received and our
responses.
Comment: Several commenters were in favor of establishing a
specific new Therapeutic Apheresis Nurse Specialist labor category for
CPT codes 36514, 36516, and 36522 because they did not believe the
current RN/LPN labor code accurately captured their nurses' specialized
skills, experience, work, and time. Commenters pointed out that
recruiting and retaining nursing personnel has been challenging, and
when competing for an experienced specialized apheresis nurse, salary
demands are higher to attract and keep them. The nominator also
mentioned that a typical apheresis nurse tends to have an extensive
clinical background and specialized therapeutic apheresis experience.
Additionally, commenters noted that these nurses spend significant time
with patients during apheresis procedures, often not leaving the
patient's bedside during the long procedure. Commenters noted that
these nurses are trained to set up specialized equipment, work with
hospital blood banks to acquire blood products, work with pharmacies
for required medications, and consult with medical and nursing staff.
Response: We thank commenters for their detailed description of the
typical duties of an apheresis nurse and how they might differ from a
general RN/LPN nurse.
Comment: Several commenters opposed the nomination of CPT codes
36514, 36516, 36522 as potentially misvalued and advised us to review
the results of the forthcoming AMA PPIS survey before making any
changes. One commenter added that there might be a clinical labor type
gap that CMS could resolve.
Response: We thank commenters for their feedback and for
acknowledging the forthcoming AMA PPIS survey.
After considering the public comments, we believe there may be a
possible disparity with the clinical labor type for this service and
that these codes would benefit from additional review in future
rulemaking. We believe that it is likely that a general RN/LPN labor
category is not adequately equivalent to an Apheresis Nurse Specialist
and while there is currently no Apheresis Nurse category listed in the
PFS, there may be existing nurse categories that can act as a
substitute, such as an oncology nurse. Therefore, for CY 2024, we are
finalizing CPT codes 36514, 36516, and 36522 as potentially misvalued.
(5) CPT Codes 44205 and 44204
An interested party nominated CPT code 44205 (Laparoscopy,
surgical; colectomy, partial, with removal of terminal ileum with
ileocolostomy), as potentially misvalued, requesting that payment for
this code be made equivalent to the higher payment for CPT code 44204
(Laparoscopy, surgical; colectomy, partial, with anastomosis). Both
codes are 090 day global codes, currently valued only in the facility
setting. CPT code 44204 has a total RVU of 45.62 for CY 2023, and CPT
code 44205 has a total RVU of 39.62 for CY 2023, with a difference of
6.00 RVUs. CPT code 44204 is associated with 5 to 6 percent more
physician work time: 455.0 minutes in total, compared to 428.5 minutes
for CPT code 44205. The
[[Page 78849]]
work RVU for CPT code 44204 is also 15 percent higher than the work RVU
for CPT code 44205. The direct PE entries for both codes are the same
regarding supplies, equipment, and clinical labor, except that in the
clinical labor and equipment entries, the number of usage minutes is
higher for CPT code 44204.
Though these two codes appear to be similar, they are still
different in their purpose, physician work times, and direct PE, with
CPT code 44204 involving more time and resources (and having a higher
payment, accordingly). For these reasons, we disagreed with the
assertion that CPT code 44205 is potentially misvalued when compared to
CPT code 44204, and we disagree to modify this payment differential by
paying more for CPT code 44205. We solicited feedback regarding the
nomination of CPT code 44205 as potentially misvalued.
We did not receive public comments on this provision, and
therefore, we are finalizing our proposal not to nominate this service
as potentially misvalued.
(6) CPT Codes 93655 and 93657
An interested party nominated CPT codes 93655 (Intracardiac
catheter ablation of a discrete mechanism of arrhythmia which is
distinct from the primary ablated mechanism, including repeat
diagnostic maneuvers, to treat a spontaneous or induced arrhythmia
(List separately in addition to code for primary procedure)) and 93657
(Additional linear or focal intracardiac catheter ablation of the left
or right atrium for treatment of atrial fibrillation remaining after
completion of pulmonary vein isolation (List separately in addition to
code for primary procedure)), as potentially misvalued. We recently
reviewed these add-on codes in the CY 2022 (86 FR 65108) and CY 2023
(87 FR 69516) final rules.
The nominator reiterated that the primary procedures involve ``high
intensity clinical decision making, complexity in the intraoperative
skills required for treatment, morbidity/mortality risks to the
patient, and work intensity'' and that the work RVUs for both of these
add-on codes should reflect the AMA RUC recommended work RVU of 7.00.
We disagreed with this value in CY 2022 and continued to believe that a
work RVU of 5.50 was appropriate for the 60 minutes of physician
service time for both codes. We saw no reason to reconsider our
valuation of CPT codes 93655 and 93657 for CY 2022 or CY 2023, and we
do not consider these codes to be potentially misvalued now and did not
propose to nominate these codes as potentially misvalued for CY 2024.
Comment: We received very few comments addressing these two cardiac
ablation add-on codes, which were finalized in CY 2023. The commenters
urged CMS to accept the AMA RUC's recommendation for CPT codes 93655
and 93657 of 7.00 work RVUs.
Response: We believe the code valuations we established in CY 2023
are accurate and that these codes are not potentially misvalued;
however, we will continue to monitor this issue and the Medicare claims
data for these codes in the coming years.
We continue to believe that the current code valuations are
accurate and most appropriate for these services. Therefore, for CY
2024, we are not finalizing these codes as potentially misvalued.
(7) CPT Code 94762 and 95800
An interested party nominated CPT code 94762 (Noninvasive ear or
pulse oximetry for oxygen saturation; by continuous overnight
monitoring (separate procedure)), a PE-only code as potentially
misvalued. The nominator noted that the technology behind this code had
changed considerably over the last 14 years, and because the PE inputs
were last reviewed in 2009, the PE items included in the service no
longer reflected current practice. In their submission, the nominator
listed equipment items for CPT code 94762, including EQ212 ``pulse
oxymetry recording software (prolonged monitoring)'' and EQ353 ``Pulse
oximeter 920 M Plus,'' which the nominator asserted are now typically
found in a one-time use supply item: SD263 ``WatchPAT pneumo-opt slp
probes'' (extended external overnight pulse oximeter device probe and
battery with bluetooth, medical magnetic tape recorder) (WatchPAT One
Device) with a cost of $99.00 each (derived from two sample invoices,
not actual invoices, included with the nomination). According to our PE
supply list, item SD263 costs $73.32, which is $25.68 less than the
amounts found in the sample invoices submitted by the nominators. The
nominator retained equipment item EQ212 ``pulse oxymetry recording
software (prolonged monitoring)'', and replaced equipment item EQ353
with ED021, a ``computer, desktop, w-monitor.
The same interested party who nominated CPT code 94762, also
nominated CPT code 95800 (Sleep study, unattended, simultaneous
recording; heart rate, oxygen saturation, respiratory analysis (e.g.,
by airflow or peripheral arterial tone), and sleep time) as potentially
misvalued. The nominator requested that CMS update PE items for this
code, asserting that the PE inputs were last reviewed in 2017. CPT code
95800 currently includes the entry of a one-time use supply item, SD263
``WatchPAT pneumo-opt slp probes'' (extended external overnight pulse
oximeter device probe and battery with bluetooth, medical magnetic tape
recorder) (WatchPAT One Device), which costs $73.32 per item, in
contrast to the pricing in the sample invoice--$99.00 each (case of 12
x $99.00 = $1,188.00).
The nominator excluded the current equipment for this code (EQ335
``WatchPAT 200 Unit with strap, cables, charger, booklet and patient
video'' and EQ336 ``Oximetry and Airflow Device'') and instead included
ED021 (``computer, desktop, w-monitor'') in the PE for this code. We
noted that we did not previously include ED021 as a specialized
equipment item dedicated to this function (and EQ212 ``pulse oxymetry
recording software (prolonged monitoring)'' was also not included in
the PE for CPT code 95800, as it was with CPT code 94762). The
nominator included the PE listings for CPT code 93245 (Heart rhythm
recording, analysis, interpretation and report of continuous external
EKG over more than 1 week up to 1 weeks) as an example of how PE supply
items for CPT code 95800 should be structured, but this code included
supply item, SD339 ``extended external ECG patch, medical magnetic tape
recorder'' and equipment item ED021 ``computer, desktop, w-monitor,''
which is presumed to be used to record the data from the ECG patch and
to be used to analyze the data.
There is no clear evidence whether the WatchPAT One Device needs or
does not need the specific monitoring and recording system (equipment
item EQ212 ``pulse oxymetry recording software (prolonged
monitoring)'') for CPT code 95800, as opposed to any other system/
process. The interested party requested the PE changes discussed above
to support their argument that these CPT codes are potentially
misvalued (see Table 9).
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We welcomed comments as to whether these codes are potentially
misvalued.
The following is a summary of the comments we received and our
responses.
Comment: One commenter disagreed with the replacement of various PE
items with alternative items. For example, for CPT code 94762, the
existing pulse oximeter 920 M Plus (CMS equipment item EQ353) would be
replaced with the disposable WatchPAT One supply item (SD263). The
commenter expressed concern about removing the pulse oximetry devices
from CPT code 94762 and whether the WatchPAT One supply item properly
assessed and monitored a patient's sleep, as described by the code.
Response: We thank commenters for their feedback. There seems to be
a general misunderstanding from the original nomination regarding which
PE items should be replaced or retained and which items are considered
duplicated, according to the public comments received.
We cannot properly assess if CPT codes 94762 and 95800 are
potentially misvalued based on the evidence submitted with the original
nomination and subsequent public comments we received in response to
the CY 2024 PFS proposed rule. After considering the public comments,
it is still unclear whether CPT codes 94762 and 95800 are potentially
misvalued. We invite the original nominator or other parties to
resubmit their nomination with information providing additional clarity
for further consideration in future rulemaking. Therefore, for CY 2024,
we are not finalizing CPT codes 94762 and 95800 as potentially
misvalued.
(8) CPT Codes 0596T and 0597T
An interested party nominated CPT codes 0596T (Initial insertion of
temporary valve-pump in female urethra) and 0597T (Replacement of
temporary valve-pump in female urethra) as potentially misvalued. This
nominator generally expressed concern about variability in MAC pricing
for the contractor-priced service and requested that CMS establish
national pricing to stabilize payments that more accurately reflected
the work, professional liability costs, and especially the nonfacility
PE for these services, including the costs associated with the Vesiflo
inFlow
[[Page 78851]]
System, the primary supply included in the procedures described by the
two Category III CPT codes. The nominator stated that the MAC-
determined payment amounts had been inappropriately low and did not
account for the time and the work involved in furnishing the services
or all of the PE. In their submission, the nominator discussed their
expected inputs for both codes. For CPT code 0596T, the nominator
asserted that a physician would typically spend 60 minutes of work
inserting the Vesiflo inFlow System. The nominator also discussed the
PE items used to furnish the procedure. These specified PE items
included a power table, a mayo stand, an examination light, clinical
labor time of a RN/LPN/MTA totaling to 73 minutes, and a list of
supplies summing to $1,902.76, primarily from the inFlow Measuring
Device of $140.00, the inflow Device of $495.00, and the inflow
Activator Kit of $1,250.00, with the inflow supply items making up
about 99 percent of the total cost of supplies.
For CPT code 0597T, the nominator asserted that a physician would
typically spend 25 minutes replacing the Vesiflo inFlow System. The
specified PE items for this service included a power table, a mayo
stand, an examination light, clinical labor time of a RN/LPN/MTA
totaling 38 minutes, and a list of supplies summing to $505.30,
primarily from the inflow device of $495.00, with the inflow supply
items making up about 98 percent of the total cost of supplies. A
sample invoice was included in this nomination (as opposed to an actual
invoice).
We welcomed comments on whether these two temporary category III
CPT codes, CPT codes 0596T and 0597T, were potentially misvalued and
whether these codes should remain contractor-priced.
The following is a summary of the comments we received and our
responses.
Comment: We received several comments supporting our proposal to
nominate CPT codes 0596T and 0597T as potentially misvalued. These
commenters recommended that we establish national pricing for these
services, stating that a change to national pricing would address the
misvaluation and pricing variability for the service and allow for the
appropriate inclusion of the Vesiflo system in the code's PE.
Response: We note that CPT codes 0596T and 0597T are category III
codes and describe relatively new and low-volume services. Generally,
category III codes are contractor-priced under the PFS, meaning that
each MAC can establish pricing for the code for areas within its
jurisdiction. We appreciate the nominators' and commenters' concerns
about variability in payment across the different MAC jurisdictions.
After consideration of public comments, we are not finalizing CPT
codes 0596T and 0597T as potentially misvalued. These are contractor-
priced codes and they will remain contractor priced for the present.
However, we encourage interested parties to continue to engage with the
MACs and provide accurate and appropriate cost data to inform the MAC's
consideration and pricing of these services.
(9) CPT Code 93000
An interested party nominated CPT code 93000 (Electrocardiogram,
routine ECG with at least 12 leads; with interpretation and report) as
potentially misvalued, arguing that we should increase Medicare payment
for CPT code 93000 to $35.64 when used in conjunction with other
supplies and services, to reflect PE costs equivalent to (1) $6.10 for
EKG leads; (2) $21.19 for a nurse visit of typically 5 minutes (as
illustrated by CPT code 99211 (Office or other outpatient visit for the
evaluation and management of an established patient, that may not
require the presence of a physician or other qualified health care
professional. Usually, the presenting problem(s) are minimal.
Typically, 5 minutes are spent performing or supervising these
services.)); and (3) $7.64 for the interpretation and report for the
EKG service (as illustrated by CPT code 93010 (Electrocardiogram,
routine ECG with at least 12 leads; interpretation and report only).
While the interested party did not provide invoices or other evidence
for consideration, they asked that we value the grouping of these
services at $35.64, even though the direct costs for these identified
PE inputs total to $34.93.
After consideration of submitted information, we decided not to
propose to nominate CPT code 93000 as potentially misvalued for CY
2024. We did not believe that the total of a mix of services is a
persuasive indication that one code--in this case, CPT code 93000--was
potentially misvalued.
We did not receive public comments on this nomination. Therefore,
for CY 2024, we are not finalizing CPT codes code 93000 as potentially
misvalued.
(10) 19 Therapy Codes
An interested party nominated 19 therapy codes as potentially
misvalued. We noted in the proposed rule that these 19 therapy codes
were last reviewed by CMS in the CY 2018 PFS final rule (82 FR 53073
through 53074). The nominators asserted that the direct PE clinical
labor minutes, as recommended by the AMA Relative Value Scale Update
Committee (RUC) and Healthcare Professional Advisory Committee (HCPAC)
Review Board, reflected inappropriate multiple procedure payment
reductions (MPPR), which are likely duplicative of the CMS MPPR policy
implemented in CMS' claims processing systems.
As discussed in the proposed rule, we reviewed the clinical labor
time entries for these 19 therapy codes. We noted that we did not
believe a payment reduction should have been applied to the 19
nominated therapy codes' clinical labor time entries (Table 10) since
the payment valuation reduction would be duplicative of the MPPR we
apply during claims processing. We proposed to nominate these 19 codes
as potentially misvalued for CY 2024, as we believed that the valuation
of these services would benefit from additional review through the AMA
RUC HCPAC valuation process. We also sought comment on our proposal.
The following is a summary of the comments we received and our
responses.
Comment: Numerous commenters supported our proposal to nominate
these 19 therapy codes as potentially misvalued. There were no comments
asserting that these codes should not be considered potentially
misvalued.
Response: After consideration of the public comments for this
issue, we are finalizing our proposal to consider the 19 therapy codes
as potentially misvalued for CY 2024.
[[Page 78852]]
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D. Payment for Medicare Telehealth Services Under Section 1834(m) of
the Act
As discussed in prior rulemaking, several conditions must be met
for Medicare to make payment for telehealth services under the PFS. See
further details and full discussion of the scope of Medicare telehealth
services in the CY 2018 PFS final rule (82 FR 53006) and CY 2021 PFS
final rule (85 FR 84502) and in 42 CFR 410.78 and 414.65.
1. Payment for Medicare Telehealth Services Under Section 1834(m) of
the Act
a. Changes to the Medicare Telehealth Services List
In the CY 2003 PFS final rule with comment period (67 FR 79988), we
established a regulatory process for adding services to or deleting
services from the Medicare Telehealth Services List in accordance with
section 1834(m)(4)(F)(ii) of the Act (42 CFR 410.78(f)). This process
provides the public with an ongoing opportunity to submit requests for
adding services, which are then reviewed by us and assigned to
categories established through notice and comment rulemaking.
Specifically, we assign any submitted request to add to the Medicare
Telehealth Services List to one of the following two categories:
Category 1: Services that are similar to professional
consultations, office visits, and office psychiatry services that are
currently on the Medicare Telehealth Services List. In reviewing these
requests, we look for similarities between the requested and existing
telehealth services for the roles of, and interactions among, the
beneficiary, the physician (or other practitioner) at the distant site,
and, if necessary, the telepresenter, a practitioner who is present
with the beneficiary in the originating site. We also look for
similarities in the telecommunications system used to deliver the
service; for example, the use of interactive audio and video equipment.
Category 2: Services that are not similar to those on the
current Medicare Telehealth Services List. Our review of these requests
includes an assessment of whether the service is accurately described
by the corresponding code when furnished via telehealth and whether the
use of a telecommunications system to furnish the service produces
demonstrated clinical benefit to the patient. Submitted evidence should
include both a description of relevant clinical studies that
demonstrate the service furnished by telehealth to a Medicare
beneficiary improves the diagnosis or treatment of an illness or injury
or improves the functioning of a malformed body part, including dates
and findings, and a list and copies of published peer reviewed articles
relevant to the service when furnished via telehealth. Our evidentiary
standard of clinical benefit does not include minor or incidental
benefits. Some examples of other clinical benefits that we consider
include the following:
Ability to diagnose a medical condition in a patient
population without access to clinically appropriate in-person
diagnostic services.
Treatment option for a patient population without access to
clinically appropriate in-person treatment options.
Reduced rate of complications.
Decreased rate of subsequent diagnostic or therapeutic
interventions (for example, due to
[[Page 78853]]
reduced rate of recurrence of the disease process).
Decreased number of future hospitalizations or physician
visits.
More rapid beneficial resolution of the disease process
treatment.
Decreased pain, bleeding, or other quantifiable signs or
symptoms.
Reduced recovery time.
Category 3: In the CY 2021 PFS final rule (85 FR 84507),
we created a third category of criteria for adding services to the
Medicare Telehealth Services List on a temporary basis following the
end of the public health emergency (PHE) for the COVID-19 pandemic.
This new category describes services that were added to the Medicare
Telehealth Services List during the PHE, for which there is likely to
be clinical benefit when furnished via telehealth, but there is not yet
sufficient evidence available to consider the services for permanent
addition under the Category 1 or Category 2 criteria. Services added on
a temporary, Category 3 basis will ultimately need to meet the criteria
under Category 1 or 2 in order to be permanently added to the Medicare
Telehealth Services List. To add specific services on a Category 3
basis, we conducted a clinical assessment to identify those services
for which we could foresee a reasonable potential likelihood of
clinical benefit when furnished via telehealth. We considered the
following factors:
++ Whether, outside of the circumstances of the PHE for COVID-19,
there are concerns for patient safety if the service is furnished as a
telehealth service.
++ Whether, outside of the circumstances of the PHE for COVID-19,
there are concerns about whether the provision of the service via
telehealth is likely to jeopardize quality of care.
++ Whether all elements of the service could fully and effectively
be performed by a remotely located clinician using two-way, audio/video
telecommunications technology.
In the CY 2021 PFS final rule (85 FR 84507), we also temporarily
added several services to the Medicare Telehealth Services List using
the Category 3 criteria described previously. In this rule, we
considered additional requests to add services to the Medicare
Telehealth Services List on a Category 3 basis using the previously
described Category 3 criteria.
The Medicare Telehealth Services List, including the additions
described later in this section, is available on the CMS website at
https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/index.html.
Beginning in CY 2019, we stated that for CY 2019 and onward, we
intend to accept requests through February 10, consistent with the
deadline for our receipt of code valuation recommendations from the RUC
(83 FR 59491). For CY 2024, requests to add services to the Medicare
Telehealth Services List must have been submitted and received by
February 10, 2023. Each request to add a service to the Medicare
Telehealth Services List must have included any supporting
documentation the requester wishes us to consider as we review the
request. Because we use the annual PFS rulemaking process as the
vehicle to make changes to the Medicare Telehealth Services List,
requesters are advised that any information submitted as part of a
request is subject to public disclosure for this purpose. For more
information on submitting a request in the future to add services to
the Medicare Telehealth Services List, including where to mail these
requests, see our website at https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/index.html.
b. Requests to Add Services to the Medicare Telehealth Services List
for CY 2024
Under our current policy, we add services to the Medicare
Telehealth Services List on a Category 1 basis when we determine that
they are similar to services on the existing Medicare Telehealth
Services List for the roles of, and interactions among, the
beneficiary, physician (or other practitioner) at the distant site,
and, if necessary, the telepresenter. As we stated in the CY 2012 PFS
final rule with comment period (76 FR 73098), we believe that the
Category 1 criteria not only streamline our review process for publicly
requested services that fall into this category, but also expedite our
ability to identify codes for the Medicare Telehealth Services List
that resemble those services already on the Medicare Telehealth
Services List.
We also note that section 4113 of Division FF, Title IV, Subtitle A
of the Consolidated Appropriations Act, 2023 (CAA, 2023) (Pub. L. 117-
328, December 29, 2022) extends the telehealth policies enacted in the
Consolidated Appropriations Act, 2022 (CAA, 2022) (Pub. L. 117-103,
March 15, 2022) through December 31, 2024, if the PHE ends prior to
that date, as discussed in section II.D.c. of this final rule.
We received several requests to permanently add various services to
the Medicare Telehealth Services List effective for CY 2024. We found
that none of the requests we received by the February 10th submission
deadline met our Category 1 or Category 2 criteria for permanent
addition to the Medicare Telehealth Services List. The requested
services are listed in Table 11.
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We remind interested parties that the criterion for adding services
to the Medicare telehealth list under Category 1 is that the requested
services are similar to professional consultations, office visits, and
office psychiatry services that are currently on the Medicare
Telehealth Services List, and that the criterion for adding services
under Category 2 is that there is evidence of clinical benefit if
provided as telehealth. As explained below and in the CY 2024 PFS
proposed rule (88 FR 52286 to 52298), we found that none of the
requested services listed in Table 11 met the Category 1 criterion.
Below is a summary of the reasons why we did not propose to add these
services to the Medicare Telehealth Services List on a Category 1
basis, the comments on the proposed rule, and our responses:
(1) Cardiovascular Procedures
We received a request to permanently add CPT code 93793
(Anticoagulant management for a patient taking warfarin, must include
review and
[[Page 78856]]
interpretation of a new home, office, or lab international normalized
ratio (INR) test result, patient instructions, dosage adjustment (as
needed), and scheduling of additional test(s), when performed)) to the
Medicare Telehealth Services List. We did not consider this service to
be a Medicare telehealth service, because the service is not an
inherently face-to-face service--a patient need not be present in order
for the service to be furnished in its entirety. For example, in many
instances, clinical staff will not change a patient's warfarin dosage
as a result of the lab INR test result, and they may or may not confirm
the need for a follow-up test via phone; either way there is no need
for a face-to-face encounter with a practitioner. As we have explained
in previous rulemaking (83 FR 59483), certain kinds of services that
are furnished remotely using communications technology are not
considered Medicare telehealth services and are not subject to the
restrictions articulated in section 1834(m) of the Act. This is true
for services that were routinely paid separately prior to the enactment
of section 1834(m) of the Act and do not usually include patient
interaction such as the remote interpretation of diagnostic tests. We
did not consider CPT code 93793 to be a telehealth service under
section 1834(m) of the Act or our regulation at Sec. 410.78.
Therefore, we did not propose to add this service to the Medicare
Telehealth Services List on a Category 1 basis.
Comment: A few commenters requested that CMS update the status
indicator for CPT code 93793 to a covered status indicator such as A, S
or V, and that CMS add the service to the telehealth list.
Response: The request for a status indicator change is outside the
scope of our telehealth proposals. However, we believe it is important
to note that the service elements of CPT code 93793 do not describe an
in-person service that could, instead, be furnished as a Medicare
telehealth service using interactive communications technology. Because
CPT code 93793 does not describe an inherently face-to-face service, it
would not be appropriate to consider or recognize it as a telehealth
service. We believe that the commenter misunderstands the nature of CPT
code 93793.
(2) Cardiovascular and Pulmonary Rehab
We received multiple requests to permanently add the following CPT
codes to the Medicare Telehealth Services List:
93797 (Physician or other qualified health care
professional services for outpatient cardiac rehabilitation; without
continuous ECG monitoring (per session)); and
94624 (Physician or other qualified health care
professional services for outpatient pulmonary rehabilitation; without
continuous oximetry monitoring (per session)).
In the CY 2022 PFS final rule (86 FR 65048), we explained that some
services were added temporarily to the Medicare Telehealth Services
List on an emergency basis to allow practitioners and beneficiaries to
have access to medically necessary care while avoiding both risk for
infection and further burdening healthcare settings during the PHE for
COVID-19. In the same rule, we considered available evidence and noted
that as evidence evolves on this subject matter, we welcomed further
discussions with interested parties on the topic. In subsequent cycles
of annual rulemaking, we have continued conversations with interested
parties that furnish, support, and use Cardiovascular and Pulmonary
Rehabilitation services. In our CY 2022 PFS final rule (86 FR 65055),
we acknowledged that commenters provided a number of studies on the
safety and efficacy of these services when furnished via telehealth,
and we added the codes to the list on a temporary, Category 3 basis.
We note that some evidence submissions and ongoing discussions with
interested parties have focused on the clinical benefits of patients
receiving these services in the home. We note that, while demonstrating
the clinical benefits of services is important to our decision whether
to add a service to the Medicare Telehealth Services List, there are
other considerations when deciding whether to add codes to the list on
a permanent basis. For example, while the CAA, 2023, does extend
certain COVID-19 PHE flexibilities, including allowing the
beneficiary's home to serve as an originating site, such flexibilities
are only extended through the end of CY 2024. Under current law,
beginning on January 1, 2025, the beneficiary's home can be an
originating site only for Medicare telehealth services furnished for:
(1) the diagnosis, evaluation, or treatment of a mental health
disorder; or (2) a beneficiary with a diagnosed substance use disorder
(SUD) for purposes of treatment of the SUD or a co-occurring mental
health disorder; or (3) monthly ESRD-related clinical assessments
furnished to a beneficiary who is receiving home dialysis, beginning
January 1, 2025. Therefore, in the absence of further action by
Congress, CPT codes 93797 and 94626 will not be able to be furnished
via telehealth to a beneficiary in the home beginning January 1, 2025.
As such, we did not propose to include these services permanently on
the Medicare Telehealth Services List on a Category 1 basis. We instead
proposed to continue to include these services on the Medicare
Telehealth Services List through CY 2024. We will then remove CPT codes
93797 and 94626 from the Medicare Telehealth Services List for CY 2025.
Comment: Commenters were generally supportive and included
supportive evidence demonstrating possible clinical benefit for the
clinical activities described by these codes.
Response: We thank commenters for the feedback.
After consideration of public comments, we are finalizing as
proposed. We will continue to include these services on the Medicare
Telehealth Services List through CY 2024. We will then remove CPT codes
93797 and 94626 from the Medicare Telehealth Services List for CY 2025.
(3) Deep Brain Stimulation
We received a request to permanently add the following CPT codes to
the Medicare Telehealth Services List:
95970 (Electronic analysis of implanted neurostimulator
pulse generator/transmitter (eg, contact group[s], interleaving,
amplitude, pulse width, frequency [Hz], on/off cycling, burst, magnet
mode, dose lockout, patient selectable parameters, responsive
neurostimulation, detection algorithms, closed loop parameters, and
passive parameters) by physician or other qualified health care
professional; with brain, cranial nerve, spinal cord, peripheral nerve,
or sacral nerve, neurostimulator pulse generator/transmitter, without
programming);
95983 (Electronic analysis of implanted neurostimulator
pulse generator/transmitter (eg, contact group[s], interleaving,
amplitude, pulse width, frequency [Hz], on/off cycling, burst, magnet
mode, dose lockout, patient selectable parameters, responsive
neurostimulation, detection algorithms, closed loop parameters, and
passive parameters) by physician or other qualified health care
professional; with brain neurostimulator pulse generator/transmitter
programming, first 15 minutes face-to-face time with physician or other
qualified health care professional); and
95984 (Electronic analysis of implanted neurostimulator
pulse generator/transmitter (eg, contact group[s], interleaving,
amplitude, pulse
[[Page 78857]]
width, frequency [Hz], on/off cycling, burst, magnet mode, dose
lockout, patient selectable parameters, responsive neurostimulation,
detection algorithms, closed loop parameters, and passive parameters)
by physician or other qualified health care professional; with brain
neurostimulator pulse generator/transmitter programming, each
additional 15 minutes face-to-face time with physician or other
qualified health care professional (List separately in addition to code
for primary procedure)).
In our CY 2023 proposed rule (85 FR 45891), we explained that these
services do not meet the Category 1 criterion for permanent addition to
the Medicare Telehealth Services List. Additionally, we discussed
concerns about whether the full scope of service elements could be
furnished via two-way, audio-video communication technology,
particularly since it is unclear whether the connection between the
implanted device and the analysis/calibration equipment can be done
remotely. Additionally, we are concerned about the immediate safety of
the patient if the calibration of the neurostimulator were done
incorrectly or if some other problem occurred. However, we did include
these services on the Medicare Telehealth Services List on a temporary
basis during the PHE to allow additional time for additional
information to be gathered and presented. Based on this information, we
believe there is some possible clinical benefit for these services when
furnished via telehealth; however, there is not yet sufficient evidence
available to consider the services for permanent addition under the
Category 2 criterion. We proposed to keep these services on the
Medicare Telehealth Services List for CY 2024. We stated that we would
consider additional evidence in future rulemaking to determine whether
to add the services to the Medicare Telehealth Services List on a
permanent basis.
Comment: Several commenters explained that early evidence shows
that safe remote programming may set devices to a safe mode in
instances where remote programming fails. Commenters asserted that
because evidence shows that patient safety risks may be mitigated
through such controls, and no evidence of patient harm had been found,
that CMS should make these services a permanent addition to the
Medicare Telehealth Services List.
Response: We consider all evidence submitted and anecdotes shared
by commenters. We generally do not question the findings and believe
that the services may be safely furnished using only two-way
interactive communications technology as a substitute for in-person
elements of the service. However, we have not received sufficient
evidence to show that the service, when furnished using only virtual
interaction, would avoid a subsequent in-person service that addresses
instances where the beneficiary received less than the complete service
(when the device enters safe mode, remote programming failed, and
requires a follow-up in-person visit so that the device may be
programmed in-person). We believe more time for further study would be
appropriate, and that adding these services to the Medicare Telehealth
Services List on a permanent basis beginning in CY 2024 would be
premature.
After consideration of public comments, we are finalizing as
proposed. We are not adding these codes to the Medicare Telehealth
Services List on a permanent basis.
(4) Therapy
We received requests to add Therapy Procedures: CPT codes 97110,
97112, 97116; Physical Therapy Evaluations: CPT codes 97161 through
97164; Therapy Personal Care services: CPT code 97530; and Therapy
Tests and Measurements services: CPT codes 97750, 97763 and
Biofeedback: 90901, to the Medicare Telehealth Services List on a
Category 1 or 2 basis. We have considered these codes over several
years, in multiple cycles of annual rulemaking. In the CY 2017 final
rule (81 FR 80198), we first assessed a request to add CPT codes 97110,
97112, and 97116 (the therapy codes) to the Medicare Telehealth
Services List. We did not add the codes to the Medicare Telehealth
Services List at the time, because there was no emergency waiver
providing an exception to the requirements under section 1834(m)(4)(E)
of the Act, and physical therapists, occupational therapists, and
speech-language pathologists were not eligible telehealth
practitioners. In the CY 2018 final rule (82 FR 53008 and 53009), we
reiterated our initial assessment that the codes were not appropriate
to add to the Medicare Telehealth Services List, because the majority
of the therapy codes listed above are furnished over 90 percent of the
time by therapy professionals who are not included on the list of
distant site practitioners who can furnish telehealth services at
section 1834(m)(4)(E) of the Act. We stated that we believed that
adding therapy services to the Medicare Telehealth Services List could
result in confusion about who is authorized to furnish and bill for
these services when furnished via telehealth (82 FR 53009).
Section 3703 of Division A, Title III, Subtitle D of the
Coronavirus Aid, Relief, and Economic Security Act (CARES Act) (Pub. L.
116-136, enacted March 27, 2020) amended section 1135(b)(8) of the Act
to give the Secretary emergency authorities to waive or modify Medicare
telehealth payment requirements under section 1834(m) of the Act during
the PHE for COVID-19. Using this authority, CMS issued a set of
emergency waivers that included waiving the restrictions in section
1834(m)(4)(E) of the Act on the types of practitioners who may furnish
telehealth services. This allowed for therapy professionals to furnish
telehealth services for the duration of the PHE. In the CY 2022 final
rule (86 FR 65051), we reviewed another round of submissions requesting
that CMS add therapy codes to the Medicare Telehealth Services List,
and we again determined that these codes did not meet the Category 1
criterion for addition to the list. In the CY 2023 PFS final rule (87
FR 69451), through our review of evidence that was submitted by
interested parties in support of adding these services to the Medicare
Telehealth Services List on a Category 2 basis, we concluded that there
was not sufficient information to determine whether all of the
necessary elements of these services could be furnished remotely.
In reviewing this year's request, the evidence submission includes
evidence similar to what was submitted last year, with a few new
additions suggesting that some elements of the individual services may
have clinical benefit when furnished via telehealth, but not resolving
uncertainty about whether other elements of the services can be fully
furnished remotely via telehealth. The evidence submitted also suggests
that receiving therapy services via telehealth in the home may offer
some practical benefits, such as use of actual stairs in therapy
exercise instead of artificial stairs, or meal preparation instructions
focused on available kitchen tools and equipment. However, the evidence
submitted for review leaves open questions as to whether such
differences in the setting of care translate to a clinical benefit that
is more than minor or incidental, in typical circumstances for the
typical population of beneficiaries who may receive therapy services
via telehealth.
We note that for any submission, including submissions received for
these therapy services, we consider all elements of a service as
described by a particular HCPCS code and apply our
[[Page 78858]]
review criteria to the specific code. While some submitted information
may focus on an individual service within one specific clinical
scenario and furnished within one specific individual model of care
delivery, that information may not be generalizable to the varied
settings and scenarios under which the service would be typically
furnished via telehealth. We reiterate that available evidence should
give a reasonable degree of certainty that all elements of the service
could fully and effectively be furnished by a remotely-located
clinician using two-way, audio/video telecommunications technology.
Based on the evidence we reviewed, we continue to question whether
the findings from therapy studies that focused on a specific clinical
issue for a narrow population (for example, joint replacement of a
specific joint) translate to clinical benefit for some or many of the
various other clinical issues that would typically be addressed when
therapists furnish therapy services via telehealth to beneficiaries.
Despite the evidence, we are still uncertain as to whether all of the
elements of a therapy service could typically be furnished through use
of only real-time, two-way audio/video communications technology.
Because we continue to have these questions, we did not propose to add
these services to the Medicare Telehealth Services List on a Category 1
or 2 basis, for the same reasons described in our CY 2018 through CY
2023 rulemaking cycles. Also, we continue to believe that adding these
therapy services to the Medicare Telehealth Services List permanently
would potentially generate confusion. As discussed in last year's final
rule, we note that we do not have authority to expand the list of
eligible Medicare telehealth practitioners to include therapists (PTs,
OTs, or SLPs) after CY 2024 (87 FR 69449 through 69451). We note that
the CAA, 2023, did not permanently change the list of practitioners who
can furnish and bill for telehealth services; rather, the CAA, 2023,
extended the current telehealth flexibilities through the end of CY
2024. That said, we proposed to keep these therapy services on the
Medicare Telehealth Services List until the end of CY 2024. We will
consider any further action with regard to these codes in future
rulemaking.
Comment: Commenters requested that CMS continue coverage of the
therapy codes even though physical therapists, occupational therapists,
and speech therapists are not currently permitted by statute to provide
telehealth services after CY 2024.
Response: We direct readers to our discussion of these codes in the
proposed rule, and we reiterate that we are still uncertain as to
whether all of the elements of a therapy service could typically be
furnished through use of only real-time, two-way audio/video
communications technology. Further, we note that the scope of our
proposals did not include coverage status of the codes, merely whether
CMS should change the status of the codes on the telehealth list.
After consideration of public comments, we are finalizing as
proposed. These therapy services will remain on the Medicare Telehealth
Services List until the end of CY 2024.
(5) Hospital Care, Emergency Department and Hospital
We received a request to permanently add the following CPT codes to
the Medicare Telehealth Services List:
99221 (Initial hospital inpatient or observation care, per
day, for the evaluation and management of a patient, which requires a
medically appropriate history and/or examination and straightforward or
low level medical decision making. When using total time on the date of
the encounter for code selection, 40 minutes must be met or exceeded.)
99222 (Initial hospital inpatient or observation care, per
day, for the evaluation and management of a patient, which requires a
medically appropriate history and/or examination and moderate level of
medical decision making. When using total time on the date of the
encounter for code selection, 55 minutes must be met or exceeded.)
99223 (Initial hospital inpatient or observation care, per
day, for the evaluation and management of a patient, which requires a
medically appropriate history and/or examination and moderate level of
medical decision making. When using total time on the date of the
encounter for code selection, 55 minutes must be met or exceeded.)
99234 (Hospital inpatient or observation care, for the
evaluation and management of a patient including admission and
discharge on the same date, which requires a medically appropriate
history and/or examination and straightforward or low level of medical
decision making. When using total time on the date of the encounter for
code selection, 45 minutes must be met or exceeded.)
99235 (Hospital inpatient or observation care, for the
evaluation and management of a patient including admission and
discharge on the same date, which requires a medically appropriate
history and/or examination and moderate level of medical decision
making. When using total time on the date of the encounter for code
selection, 70 minutes must be met or exceeded.)
99236 (Hospital inpatient or observation care, for the
evaluation and management of a patient including admission and
discharge on the same date, which requires a medically appropriate
history and/or examination and high level of medical decision making.
When using total time on the date of the encounter for code selection,
85 minutes must be met or exceeded.)
99238 (Hospital inpatient or observation discharge day
management; 30 minutes or less on the date of the encounter)
99239 (Hospital inpatient or observation discharge day
management; more than 30 minutes on the date of the encounter)
99281 (Emergency department visit for the evaluation and
management of a patient that may not require the presence of a
physician or other qualified health care professional)
99282 (Emergency department visit for the evaluation and
management of a patient, which requires a medically appropriate history
and/or examination and straightforward medical decision making)
99283 (Emergency department visit for the evaluation and
management of a patient, which requires a medically appropriate history
and/or examination and low level of medical decision making)
In the March 31, 2020 interim final rule with comment period (IFC-
1) (85 FR 19234), we added the above services to the Medicare
Telehealth Services List on a Category 2 basis for the duration of the
PHE for COVID-19, for telehealth services with dates of service
beginning March 1, 2020 through the end of the PHE (including any
renewals of the PHE). When we previously considered adding these
services to the Medicare Telehealth Services List, either through a
public request or through our own internal review, we considered
whether these services met the Category 1 or Category 2 criteria. In
many cases, we reviewed requests to add these services to the Medicare
Telehealth Services List on a Category 1 basis but did not receive or
identify information that allowed us to determine whether these
services should be added on a Category 2 basis (CY 2017 PFS final rule,
at 81 FR 80194 to 80197). We reiterated that, while we do not believe
the context of the PHE for COVID-19 changes the assessment of whether
these services meet the Category 1 criterion, we reassessed all of
these services to determine whether they meet the criteria for
inclusion on
[[Page 78859]]
the Medicare Telehealth Services List on a Category 2 basis, in the
context of the widespread presence of COVID-19 in the community. Given
the exposure risks for beneficiaries, the health care work force, and
the community at large, in-person interaction between professionals and
patients posed an immediate potential risk that would not have been
present when we previously reviewed these services in 2017. This risk
created a unique circumstance where health care professionals needed to
weigh the risks associated with disease exposure. For further
background, in the CY 2021 final rule (FR 84506 through 84509), we
explained the reasoning and considerations necessary for assigning a
Category 3 status to certain codes that were added to the Medicare
Telehealth Services List on a temporary basis during the PHE for COVID-
19. We believe that some risk of COVID-19 remains, but also remain
uncertain that available evidence gives clear support for continuing to
include these services on a permanent basis under the Category 2
criterion.
As discussed in the CY 2023 PFS final rule (86 FR 69450), we
believe these hospital and emergency department services may continue
to be furnished safely via two-way, audio-video communication
technology. We did not propose to add these services to the list on a
permanent basis at this time, but we did propose that they would remain
available on the Medicare Telehealth Services List through CY 2024.
Comment: Several commenters stated that because CMS had adopted the
AMA CPT Editorial Committee's consolidation of E&M inpatient and
observation codes that CMS should change their status on the telehealth
list to make these codes permanent.
Response: We acknowledge the CPT Editorial Panel deleted seven
observation care codes and revised nine codes effective January 1,
2023, to create a single set of codes for inpatient and observation
care and also made changes to codes for inpatient and observation
discharge. We adopted the E/M inpatient/observation revisions in the CY
2023 PFS final rule. For further background, refer to 87 FR 69586
through 69587. In the CY 2023 PFS final rule, when we finalized new
valuations based on AMA RUC recommendations which included a change in
code descriptors to reflect ``patient history and/or physical exam'' as
one element of the service, we removed the legacy codes from the list
and replaced these with the new code set. To reiterate, we have open
questions of patient safety that we expect future submissions to
address in full, as evidence generation builds (for example,
publication of peer-reviewed literature, updates clinical practice
guidelines, further study of hospital patient safety risks). We note
that the initial impetus for including these services on the Medicare
Telehealth Services List focused on the unique circumstance where
health care professionals needed to weigh the risks associated with
disease exposure during PHE for COVID-19. Now that the PHE has ended,
we expect that future evidence submissions would address study of the
appropriateness of furnishing these services via telehealth outside the
context of a global pandemic. We note that we have no immediate
evidence of patient safety risks associated specifically with
furnishing these services via telehealth but we remain cautious and
intend to monitor these services moving forward because of possible
larger issues of patient safety.\3\ With regard to the code
consolidation, we reiterate our concerns above, and note that prior to
consolidation, none of the separate ``legacy'' codes, which are now
consolidated, were on the Medicare Telehealth Services List on a
permanent basis.
---------------------------------------------------------------------------
\3\ Fleisher, L. A., Schreiber, M., Cardo, D., & Srinivasan, A.
(2022). Health Care Safety during the pandemic and beyond --
building a system that ensures resilience. New England Journal of
Medicine, 386(7), 609-611. https://doi.org/10.1056/nejmp2118285.
---------------------------------------------------------------------------
After consideration of public comments, we are finalizing as
proposed and will keep these hospital and emergency department services
on the Medicare Telehealth Services List temporarily through CY 2024.
We note that CPT codes 99231 through 99233 are codes that describe
subsequent services, and are part of the same Hospital or Observation
Care code family (CPT codes 99218-99236), and have permanent status on
the Medicare Telehealth Services List. We continue to believe that new
patients should be seen in person when the temporary telehealth
flexibilities end, and as a result we are not changing determinations
of the status of any of these codes.
(6) Health and Well-Being Coaching
We received a request to permanently add the following three Health
and Well-being Coaching services to the Medicare Telehealth Services
List:
CPT code 0591T (Health and well-being coaching face-to-
face; individual, initial assessment);
CPT code 0592T (Health and well-being coaching face-to-
face; individual, follow-up session, at least 30 minutes); and
CPT code 0593T (Health and well-being coaching face-to-
face; group (2 or more individuals), at least 30 minutes).
We did not propose to add these health and well-being coaching
services to the Medicare Telehealth Services List on a permanent basis,
but we proposed to add them to the list on a temporary basis for CY
2024. The evidence included in the submitter's request notes that these
codes are similar to others already available on the Medicare
Telehealth Services List. Further, it appears that all elements of
these services may be furnished when using two-way interactive
communications technology to replace the face-to-face elements of the
service. The submission, which contained two published metanalyses of
literature on the clinical topic and an additional pre-publication
meta-analysis that focuses on outcomes and benefits of the delivery of
virtual health and well-being coaching, leaves some open questions as
to whether Medicare beneficiaries would receive meaningful clinical
benefit from receiving virtual-only health and well-being coaching.
While the evidence is clearly evolving, it does suggest that these
services could possibly meet Category 2 criteria for inclusion on the
Medicare Telehealth Services List as more evidence builds. We also
noted in the proposed rule that the published meta-analyses in the
submission make clear that further study is necessary for a broader
range of medical professionals, because conceptual articles and
research and existing practice articles focus on nurses but are sparse
or silent about other general categories of medical professionals. We
stated that we would expect that any evidence in support of adding
these codes on a permanent basis should also establish clinical benefit
when delivered directly by or under the supervision of the types of
professionals who are Medicare telehealth practitioners. The
metanalyses demonstrate that health coaching only requires a few hours
of training, and few articles submitted to CMS discussed the intensity
of health coach training at all. The pre-publication metanalysis
submitted for review had less than definitive conclusions about
``potential benefits'' of health and well-being coaching and hedged
that the authors, ``did not find evidence of long-term benefit,
possibly due to the paucity of studies examining longer-term outcomes.
We caution that the certainty in the evidence for the majority of
outcomes was either very low or low, primarily due to high risk of
bias, heterogeneity, and impression.'' The submission and its content
were
[[Page 78860]]
sufficient to serve as a basis for adding the codes to the Medicare
Telehealth Services List on a temporary basis, and we appreciated the
thoughtful and transparent way the submission laid out gaps in
available evidence. More time is needed to potentially close these
gaps. We are not aware of any evidence to suggest that it would be
inappropriate to assign a temporary status to these codes. Therefore,
we proposed to add the services to the Medicare Telehealth Services
List on a temporary basis.
Comment: Many commenters requested that CMS change the status of
these codes to permanent. The commenters referenced that the National
Board of Health and Wellness Coaches, which is an affiliate of the
National Board of Medical Examiners, along with other standard-setting
organizations, represent 28,000 qualified coaching professionals;
additional evidence submitted addresses the rigor of training and
certification requirements, as well as findings on clinical
effectiveness of health and wellness coaching services delivered via
telehealth to treat chronic disease prevalent in the Medicare
population (for example, obesity, hypertension, diabetes, and COPD).
The commenters asserted that over 9,500 health professionals have
completed a certification exam, and approximately 20 percent of those
holding certification also hold a clinical State license of some kind.
Response: We thank commenters for the feedback and additional
evidence submission. We acknowledge the findings presented in the
additional evidence, and the qualifications required to achieve
certification that comments referenced. We note that there are over 4
million NPIs in the NPPES NPI Registry (http://npiregistry.cms.hhs.gov), and that we do not consider the number of
certified individuals providing a service in determining the status of
a service on the Medicare Telehealth List. Rather, when pointing to
gaps in the available evidence supporting inclusion of a service on the
list, we ask whether further study is necessary to establish the
clinical benefit of a service for the Medicare population when the
individual service is performed using only two-way interactive
communications technology as a substitute for face-to-face interactions
between the telehealth practitioner and the patient. The clinical value
of the service is not at issue when CMS determines whether or how to
include a service on the Medicare Telehealth Services List.
We remind readers that one purpose of the telehealth review, and
our ongoing claims monitoring process that examines utilization of
telehealth services, is for CMS to act as an appropriate safeguard to
ensure that beneficiaries can receive all of the elements and benefits
of a service when that service is furnished via telehealth rather than
in-person. CMS asks whether it is likely that a typical beneficiary
receiving the service would receive any clinical benefit beyond mere
incidental or minor clinical benefits when the service is performed by
the typical telehealth practitioner. When assessing the clinical
benefit of a service when furnished as a telehealth service, long-term
and careful study over a period of years may be necessary. We believe
the commenters are suggesting that there is potential clinical benefit
to providing these services via telehealth, and we agree. Our initial
review of evidence also indicates that these services can and should
retain their current status on the Medicare Telehealth Services List
for CY 2024. However, we remain cautious because the evidence and
analyses provided by commenters appear anecdotal. In future evidence
submissions, we would expect to see peer-reviewed literature, where the
study population is typical of the Medicare population (for example,
specific age bands in study populations), and the methods focus on
evaluating utilization and outcomes (for example, claims data and
analysis that includes the specific codes at issue). In summary, there
is still a lack of scientific study that focuses on use of these codes
via telehealth, and in clinical practice. We acknowledge that health
coaches may have many types of backgrounds, and we note that we did not
intend to question the standards and training of health coaches when we
mentioned the variation in their credentialling in the proposed rule.
We agree with commenters that suggested many eligible health
practitioners would furnish these services to Medicare beneficiaries if
they remained on the Medicare Telehealth Services List permanently.
Even so, the clinical benefits of these services when furnished as
telehealth services for the target population remain an open question
in need of further study. We believe that this response should provide
further clarity for the public as to the sorts of data that CMS would
like to receive and review in future submissions.
After consideration of public comments, we are finalizing as
proposed. We will add these health and well-being coaching services to
the Medicare Telehealth List on a temporary basis for CY 2024.
(7) CMS Proposal To Add New Codes to the List
We proposed to add HCPCS code G0136 (Administration of a
standardized, evidence-based Social Determinants of Health Risk
Assessment tool, 5-15 minutes) to the Medicare Telehealth Services
List. Our proposal to add HCPCS code G0136 to the list was contingent
upon finalizing the service code description we proposed in section
II.E. of the proposed rule. We refer readers to the proposal in section
II.E. of the proposed rule for further background (88 FR 52293). We
proposed that HCPCS code G0136, if finalized as proposed, would receive
a permanent status on the Medicare Telehealth Services List. One
element of the service describes a face-to-face encounter between the
clinician and beneficiary. Practitioners use clinical judgement to
determine whether to complete the SDOH screening with or without direct
patient interaction. Because the service description, as defined in
section II.E. of the CY 2024 proposed rule and finalized in section
II.E. of this final rule, expects that a patient encounter may be
necessary for accurate and complete screening, we believe that this
element of the service describes an inherently face-to-face clinical
activity. Further, using two-way interactive audio-video technology as
a substitute for in-person interaction means an analogous level of care
in that using either modality would not affect the accuracy or validity
of the results gathered via a standardized screening tool. As discussed
in section II.E. of the proposed rule, we proposed that this service
must be furnished by the practitioner on the same date they furnish an
E/M visit, as the SDOH assessment would be reasonable and necessary
when used to inform the patient's diagnosis, and treatment plan
established during the visit. Therefore, we noted that we believe HCPCS
code G0136 describes a service that is sufficiently similar to services
currently on the Medicare Telehealth Services List, specifically E/M
services, and that this service should be added to the list on a
permanent basis.
Comment: Many commenters supported our proposals to include G0136
(Administration of a standardized, evidence-based Social Determinants
of Health Risk Assessment tool, 5-15 minutes) on the Medicare
Telehealth List as a permanent code.
Response: We thank commenters for the feedback.
[[Page 78861]]
After consideration of public comments, we are finalizing as
proposed and assigning HCPCS code G0136 (Administration of a
standardized, evidence-based Social Determinants of Health Risk
Assessment tool, 5-15 minutes) permanent status on the Medicare
Telehealth List, beginning in CY 2024.
Comment: Many commenters requested that CMS add Principal Illness
Navigation (PIN) and Community Health Integration (CHI) services to the
Medicare Telehealth List.
Response: We refer readers to our discussion of the PIN and CHI
services in section II.E. of this final rule. We did not propose to add
these services to the Medicare Telehealth Services List for CY 2024
because the elements of the individual services in the code descriptors
may not typically require a face-to-face interaction, and therefore PIN
(G0023, G0024, G0140, and G0146) and CHI (G0019, G0022) would not be
considered as potential Medicare telehealth services under section
1834(m) of the Act. We note that the possible use of asynchronous
communications technology to support the provision of these services
suggests that our policies for other communications-based technology
services should apply instead.
c. Proposed Clarifications and Revisions to the Process for Considering
Changes to the Medicare Telehealth Services List
1. Overview
In CY 2020, CMS issued an array of waivers and new flexibilities
for Medicare telehealth services to respond to the serious public
health threats posed by the spread of COVID-19 (85 FR 19230). Our goal
was to give individuals and entities that provide services to Medicare
beneficiaries the flexibility to respond effectively to the serious
public health threats posed by the spread of COVID-19. Recognizing the
urgency of this situation and understanding that some pre-existing
Medicare payment rules (including the statutory restrictions on
telehealth originating sites and telehealth practitioners) needed to be
modified to allow patients and practitioners to have access to
necessary care while mitigating the risks from COVID-19, we used waiver
and regulatory authorities to change certain Medicare payment rules
during the PHE for COVID-19 so that physicians and other practitioners,
home health and hospice providers, inpatient rehabilitation facilities,
rural health clinics (RHCs), and federally qualified health centers
(FQHCs) would be allowed broad flexibilities to furnish services using
remote communications technology to avoid exposure risks to health care
providers, patients, and the community.
In 2003, as required by section 1834(m)(4)(F)(ii) of the Act, we
established a process for adding or deleting services from the Medicare
Telehealth Services List, which included consideration under two
categories of criteria (Categories 1 and 2) (67 FR 79988). We finalized
revisions to the Category 2 review criterion in the CY 2012 PFS final
rule (76 FR 73102). Prior to CY 2020, CMS had not added any service to
the Medicare Telehealth Services List on a temporary basis. In CY 2020,
in response to the PHE for COVID-19, we revised the criteria for adding
or removing services on the Medicare Telehealth Services List using a
combination of emergency waiver authority and interim final rule
making, so that some services would be available for the duration of
the PHE on a ``temporary Category 2 basis.'' (85 FR 19234). In the CY
2021 PFS final rule (85 FR 84507), we created a third, temporary
category for services included on the Medicare Telehealth Services List
on a temporary basis. This new Category 3 includes many, but not all of
the services that we added temporarily to the Medicare Telehealth
Services List during the COVID-19 PHE. Specifically, we reviewed the
services we added temporarily in response to the COVID-19 PHE and
identified those for which there is likely to be clinical benefit when
furnished via telehealth, but there is not yet sufficient evidence
available to add the services as permanent additions to the list.
Services added to the Medicare Telehealth Services List on a temporary,
Category 3 basis will ultimately need to meet the Category 1 or 2
criteria in order to be added to the Medicare Telehealth Services List
on a permanent basis.
Between CY 2020 and CY 2023, we added many services to the Medicare
Telehealth List on a temporary basis during the PHE, and through
rulemaking, we also added many of these services on a Category 3 basis.
Subsequent requests and evidence submitted to CMS supported possible
status changes for some of the services that are currently included on
the Medicare Telehealth Services List on a Category 3 basis. However,
submissions sometimes confused our use of waiver authority and
regulatory flexibilities tied to the COVID-19 PHE which allow us to
temporarily add services to the Medicare Telehealth Services List
through the end of the PHE, with the generally applicable categories
and criteria we use to consider changes to the Medicare Telehealth
Services List outside the circumstances of the COVID-19 PHE. Now that
the PHE for COVID-19 has ended, we intend to clarify and modify our
process for making changes to the Medicare Telehealth Services List. We
believe these clarifications will help address potential confusion
among interested parties that submit requests for additions to the
Medicare Telehealth List stemming from the distinction between services
that were added to the telehealth list on the basis of COVID-19 PHE-
related authorities versus services that were added temporarily on a
Category 3 basis, which does not rely on any PHE-related authority.
Specifically, we created the Category 3 basis for considering changes
in the Medicare Telehealth Services List as part of the process we are
required to establish under section 1834(m)(4)(F)(2) for considering
changes to the list in part because, with the significant expansion of
remotely-furnished services in response to the COVID-19 PHE, we
recognized the emergence of new data suggesting that there may be
clinical benefit when certain services are delivered via telehealth,
but more time is needed to develop additional evidence to support
potential addition of the services on a permanent, Category 1 or
Category 2 basis. Under Category 3, services are added to the list on a
temporary basis to allow them to continue to be furnished via
telehealth while additional evidence is developed.
In brief, throughout the COVID-19 PHE, we have reviewed all
requests to add services to the Medicare Telehealth Services List and
assessed whether the services in question should be added to the list,
temporarily or permanently, under any of the criteria for Category 1,
2, or 3. Further, we did not reject any submissions from interested
parties simply because they requested consideration under a specific
category, and the submitted data did not support adding the service to
the Medicare Telehealth Services List on that basis. Instead, we
considered whether the service(s) should be added to the Medicare
Telehealth Services List on any basis.
To avoid potential continuing confusion among those who submit
requests to add services to the Medicare Telehealth Services List, and
as we consider the expiration of the Medicare telehealth flexibilities
extended by the CAA, 2023 through the end of CY 2024, we believe it
would be beneficial to simplify our current taxonomy and multicategory
approach to considering submitted requests. Further, we believe that
simplification toward a binary
[[Page 78862]]
classification approach could address the confusion we have noticed
from interested parties submitting requests during the PHE. The
simplification restores the simple binary that existed with Category 1
and 2, without displacing or disregarding the flexibility of Category
3. We are finalizing our proposal to simply classify and consider
additions to the Medicare Telehealth Services List as either permanent,
or provisional.
As we discussed in our CY 2024 proposed rule (88 FR 52262), to
consider a request to add a service to the Medicare Telehealth Services
List, we need evidence that supports how the telehealth service is
either clinically equivalent to a telehealth service already
permanently on the list, or evidence that presents studies where
findings suggest a clinical benefit sufficient for the service to
remain on the list to allow time for confirmative study. We reemphasize
the need for clinical evidence because that evidence serves as the
principal basis for our consideration of a request; and it is sometimes
missing from submissions we receive.
For example, we have received some submissions requesting the
addition of services to the Medicare Telehealth Services List that are
essentially framed as position papers advocating for changes in
statutory requirements of section 1834(m) of the Act. While we do give
such requests due consideration, the omission of clinical evidence to
support the addition of a service to the Medicare Telehealth Services
List using our established criteria generally leads us to conclude that
the service should not be proposed for addition to the list. A fair and
consistent review process for any and all submissions relies on a
standard application of uniform, repeatable procedures for any
individual submission, just as sound evidence should describe
repeatable methods and replicable findings. Submissions that rely on
narrative arguments for changes in the substantive requirements do not
fit within such a fair and consistent review process. Therefore, we
believe the following restatement of requirements and our review
process is appropriate. We also proposed some procedural refinements to
the review process, specifically incorporating additional
considerations into our evaluation of services, that we believe would
serve to maintain scope and focus in a post-PHE context. We discussed
these proposed changes in detail in the CY 2023 PFS proposed rule and
in the following section.
Section 1834(m)(4)(F)(ii) of the Act requires that the Secretary
establish a process that provides, on an annual basis, for the addition
or deletion of services (and HCPCS codes), to the definition of
telehealth services for which payment can be made when furnished via
telehealth under the conditions specified in section 1834(m). As
specified at Sec. 410.78(f), with the exception of a temporary policy
that was limited to the PHE for COVID-19, we make changes to the list
of Medicare telehealth services through the annual physician fee
schedule rulemaking process. The proposed revisions to our current
permanent policies, specifically our proposed assignment of a
``permanent'' or ``provisional'' status to a service and changes in
status as described below, reflect the stepwise method by which we
proposed to consider future requests to add services to, remove
services from, or change the status of, services on the Medicare
Telehealth Services List, beginning for the CY 2025 Medicare Telehealth
Services List, which will include submissions received no later than
February 10, 2024.
2. Proposed Steps of Analysis for Services Under Consideration for
Addition, or Removal, or a Change in Status, as Updates to the Medicare
Telehealth Services List
Step 1. Determine whether the service is separately payable under
the PFS.
When considering whether to add, remove, or change the status of a
service on the Medicare Telehealth Services List, we proposed to first
determine whether the service, as described by the individual HCPCS
code, is separately payable under the PFS. Under section 1834(m)(1) of
the Act, Medicare telehealth services are limited to those for which
payment can be made to the physician or practitioner when furnished
using an interactive telecommunications system notwithstanding that the
practitioner furnishing the services is not in the same location as the
beneficiary; and under section 1834(m)(2)(A) of the Act, Medicare pays
the same amount for a telehealth service as if the service is furnished
in person. As such, Medicare telehealth services are limited to those
services for which separate Medicare payment can be made under the PFS.
Thus, through Step 1, we would answer the threshold question of
whether a service is separately payable under the PFS. During the PHE,
many submissions for addition to the Medicare Telehealth Services List
advocated for CMS to change the definition of ``Medicare telehealth
service'' for their specific service; some of those submissions were
for services that were not separately payable under the PFS.\4\ (87 FR
69449). In the proposed rule, we anticipated that Step 1, if finalized,
would encourage submissions that focus on a separately payable PFS
service, and that the evidence included with those submissions will
show how use of interactive, two-way, audio/video telecommunications
technology allows a practitioner to complete an entire, specific
service, described by a HCPCS code, that is equivalent to an in-person
service.
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\4\ Services on the Medicare Telehealth List are used in the
definition of Medicare telehealth. Some submissions may have
conflated the distinction. Step 1 clarifies. Refer to the CMS
website instructions for a Request for Addition at https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/Addition.
---------------------------------------------------------------------------
We recognize that certain codes that had non-payable or bundled
(not separately payable) status under the PFS before the PHE for COVID-
19 were temporarily included on the Medicare Telehealth Services List
to facilitate access to health care services during the PHE. However,
the PHE for COVID-19 has now expired.
We believe that proposed Step 1, if finalized, would lessen the
administrative burden of our telehealth services review process for
both CMS and the public. We note that before gathering evidence and
preparing to submit a request to add a service to the Medicare
Telehealth Services List, the submitter should first check the payment
status for a given service and ensure that the service (as identified
by a HCPCS code), is a covered and separately payable service under the
PFS (as identified by payment status indicators A, C, T, or R on our
public use files). For a full list of all PFS payment status indicators
and descriptions, see the Medicare Claims Processing Manual (IOM Pub.
100-04, chapter 23, section 30.2.2) and the Addendum for the MPFSDB
File Record Layout. Researchers and others preparing submissions should
also refer to the data dictionaries available at https://resdac.org/cms-data/files/carrier-ffs/data-documentation, to review whether the
methodology and conclusions contained in supporting evidence, or a
submission itself, applies an appropriate methodology to study both
individual services and individuals that are representative of the
Medicare population.
We further proposed that, if we find that a service identified in a
submission is not separately payable under the PFS, we would not
conduct any further
[[Page 78863]]
review of that service. We would identify the code submitted for
consideration and explain that we did not propose it for addition. CMS
sends confirmation from [email protected] when we
receive a submission requesting addition of a service to, removal of a
service from, or a change in status for a service included on, the
Medicare Telehealth Services List. We proposed to inform each submitter
in the confirmation whether the submission was complete, lacking
required information, or outside the scope of issues we consider under
the process for considering changes in the Medicare Telehealth Services
List. We noted that we also expect submissions to include copies of any
source material used to support assertions, which has been the
longstanding direction included in our website instructions. For
further background, refer to details available on our website at
https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/Addition.
Step 2. Determine whether the service is subject to the provisions
of section 1834(m) of the Act.
If we determine at Step 1 that a service is separately payable
under the PFS, we propose to apply Step 2 under which we would
determine whether the service at issue is subject to the provisions of
section 1834(m) of the Act. A service is subject to the provisions of
section 1834(m) of the Act when at least some elements of the service,
when delivered via telehealth, are a substitute for an in-person, face-
to-face encounter, and all of those face-to-face elements of the
service are furnished using an interactive telecommunications system as
defined in Sec. 410.78(a)(3). The aim of this step is to determine
whether the service is, in whole or in part, inherently a face-to-face
service. As we discussed in the CY 2018 PFS final rule (83 FR 59483),
it has long been the case that certain services that are furnished
remotely using communications technology are not considered Medicare
telehealth services and are not subject to the requirements of section
1834(m) of the Act. We proposed Step 2 to emphasize the circumstances
under which the criteria under section 1834(m) of the Act apply, and
also highlight circumstances in which the criteria under section
1834(m) of the Act do not apply. As previously noted, section 1834(m)
of the Act provides for payment to a physician or practitioner for a
service furnished via an interactive telecommunications system
notwithstanding that the furnishing practitioner and patient are not in
the same location at the same amount that would have been paid if the
service was furnished without the telecommunications system. We read
this to mean that the scope of section 1834(m) of the Act is limited to
services that would ordinarily be furnished with the furnishing
practitioner and patient in the same location.
Our application of Step 2 remains consistent with longstanding
policy. We reiterate that there is a range of services delivered using
certain telecommunications technology that do not fall within the scope
of Medicare telehealth services, though they are separately payable
under the PFS. Such services generally include services that do not
require the presence of, or involve interaction with, the patient (for
example, remote interpretation of diagnostic imaging tests, and certain
care management services). Other examples include virtual check-ins, e-
visits, and remote patient monitoring services which involve the use of
telecommunications technology to facilitate interactions between the
patient and practitioner, but do not serve as a substitute for an in-
person encounter, for example, to assess whether an in-person or
telehealth visit is needed or to transmit health information to the
practitioner.
In determining whether a service is subject to the provisions of
section 1834(m) of the Act, we will consider whether one or more of the
elements of the service, as described by the particular HCPCS code at
issue, ordinarily involve direct, face-to-face interaction between the
patient and practitioner such that the use of an interactive
telecommunications system to deliver the service would be a substitute
for an in-person visit. For interested parties preparing a request to
add a service to the Medicare Telehealth Services List, we believe this
Step 2 clarifies that a service must be inherently a face-to-face
service. We believe reframing this Step 2 has the practical advantage
of refining and improving consistency. We do not believe it would be
appropriate to add a service to the Medicare Telehealth Services List
if it is not subject to section 1834(m) of the Act. We would explain
our finding in notice and comment rulemaking.
Step 3. Review the elements of the service as described by the
HCPCS code and determine whether each of them is capable of being
furnished using an interactive telecommunications system as defined in
Sec. 410.78(a)(3).
We believe that the proposed Step 3 is fundamental to our
commitment to health equity, as this step could have a beneficial
impact on access to care for vulnerable populations. Step 3 is
corollary to Step 2, and used to determine whether one or more elements
of a service are capable of being delivered via an interactive
telecommunication system as defined in Sec. 410.78(a)(3). In Step 3,
we consider whether one or more face-to-face component(s) of the
service, if furnished via audio-video communications technology, would
be equivalent to the service being furnished in-person, and we seek
information from submitters to demonstrate evidence of substantial
clinical improvement in different beneficiary populations that may
benefit from the requested service when furnished via telehealth,
including, for example, in rural populations. The services are not
equivalent when the clinical actions, or patient interaction, would not
be of similar content as an in-person visit, or could not be completed.
We note that completing each element of the defined service is a
different question than whether a beneficiary receives any benefit at
all from the telehealth-only form of a candidate service. The practical
basis for Step 3 mirrors the practical basis for proposed Step 1 and 2,
which is a consistent application of review criteria. Many submissions
that CMS received during the PHE lacked evidence indicating that some
or all elements of a service could be completed using an interactive
telecommunications system without still requiring an in-person
interaction with a patient to furnish the complete service. We note
that studies of patient satisfaction alone, and submissions with an
excessive focus on patient satisfaction alone, present risks of bias in
many ways, possibly complicating or obfuscating the question of whether
it is possible, or potentially safe, to deliver an inherently face-to-
face service via telehealth. Step 3 is integral to avoiding the
possible unintended consequences of creating new gaps in care when
telehealth is used as a substitute for in-person care.
Step 4. Consider whether the service elements of the requested
service map to the service elements of a service on the list that has a
permanent status described in previous final rulemaking.
The purpose of the proposed Step 4 of our analysis is to simplify
and reduce the administrative burden of submission and review. For Step
4, we proposed to consider whether the service elements of a code that
we are considering for addition to, or removal from, the Medicare
Telehealth Services List map to the service elements of a service that
is already on the list and has a permanent status, because any code
that satisfies this criterion would require no
[[Page 78864]]
further analysis: if a code describes a service that maps to the
service elements of a code that is included on the Medicare Telehealth
Services List on a permanent basis, we would add the code to the
Medicare Telehealth Services List on a permanent basis.
We note that section 1834(m)(4)(F)(i) of the Act defines telehealth
services as professional consultations, office visits, and office
psychiatry services (as identified as of July 1, 2000, by HCPCS codes
99241-99275, 99201-99215, 90804-90809, and 90862 (and as subsequently
modified by the Secretary)), and any additional service specified by
the Secretary. Over the years, CMS has assigned Category 1 (permanent)
status to services that were either included in the list of codes
specified in section 1834(m)(4)(F)(i) of the Act or added as successor
codes to those enumerated by statute. Successor codes are updates to or
replacements for the codes listed in section 1834(m)(4)(F)(i) of the
Act. Therefore, this proposed step would ensure that CMS includes
successor codes on the Medicare Telehealth Services List. We note that
even if a code that we are considering for addition to the Medicare
Telehealth Services List is not a successor code, we would consider
whether the service described in the submission is similar to
professional consultations, office visits, and office psychiatry
services that are already on the Medicare Telehealth Services List on a
permanent basis. While we have not previously found that the elements
of service we are considering for addition to the list map to the
elements of a service that was previously added to the list on a
permanent basis using the Category 2 criteria, we believe that it would
be appropriate to apply this step 4 analysis to compare the candidate
service with any permanent code that is on the list on a permanent
basis. As such, in step 4, we proposed to maintain any previous
analytical determinations from Steps 1 through 3 and directly map the
successor code to a code on the list that has a permanent status
described in previous final rulemaking. For example, if a code
currently categorized as a finalized Category 2 permanent code was
replaced or revised by a successor code in a future year, CMS would
ensure that these revisions did not change the Step 1-3 results and add
the successor code under Step 4. We further proposed that if we find
that the service we are considering satisfies Step 4, we would end our
review and propose to add the service to the Medicare Telehealth
Services List on a permanent basis in the next PFS proposed rule. When
Step 4 is met, further evidence review is not necessary. We proposed to
continue to Step 5 if Step 4 was not met.
Step 5. Consider whether there is evidence of clinical benefit
analogous to the clinical benefit of the in-person service when the
patient, who is located at a telehealth originating site, receives a
service furnished by a physician or practitioner located at a distant
site using an interactive telecommunications system.
Similar to Steps 3, 4, and 5 above, the purpose of the proposed
step 5 is to simplify and reduce the administrative burden. Under
proposed Step 5, we would review the evidence provided with a
submission to determine the clinical benefit of a service. We would
then compare the clinical benefit of that service, when provided via
telehealth, to the clinical benefit of the service if it were to be
furnished in person. Proposed Step 5 would continue the existing
standard that we have applied when considering whether to add a code to
the Medicare Telehealth Services List on a Category 2 basis. We further
proposed that: if there is enough evidence to suggest that further
study may demonstrate that the service, when provided via telehealth,
is of clinical benefit, CMS would assign the code a ``provisional''
status on the Medicare Telehealth Services List. Where the clinical
benefit of a service, when provided via telehealth, is clearly
analogous to the clinical benefit of the service when provided in
person, CMS would assign the code ``permanent'' status on the Medicare
Telehealth Services List, even if the code's service elements do not
map to the service elements of a service that already has permanent
status.
We reminded readers that our evidentiary standard of demonstrated
clinical benefit does not include minor or incidental benefits (81 FR
80194), and if finalized, our proposal would not alter or displace this
longstanding requirement. We will review the evidence submitted by
interested parties, and other evidence that CMS has on hand. The
evidence should indicate that the service can be safely delivered using
two-way interactive audio-video communications technology. Clinical
practice guidelines, peer-reviewed literature, and similar materials,
should illustrate specifically how the methods and findings within the
material establish a foundation of support that each element of the
defined, individual service described by the existing face-to-face
service code has been studied in the typical setting of care, typical
population of beneficiaries, and typical clinical scenarios that
practitioners would encounter when furnishing the service using only
interactive, two-way audio-video communications technology to complete
the visit or encounter with Medicare beneficiaries. This analysis is
fundamental to either of the current Category 1 or Category 2
descriptions.
General evidence may also answer the question of whether a certain
beneficiary population requiring care for a specific illness or injury
may benefit from receiving a service via telehealth versus receiving no
service at all, but must establish that the service is a substitute for
an equivalent in-person service. Evidence should demonstrate how all
elements described by the individual service code can be met when two-
way, interactive audio-video communications technology is used as a
complete substitute for any face-to-face interaction required between
the patient and practitioner that are described in the individual code
descriptor. We further remind readers that submissions reflecting
practitioner services furnished to Medicare beneficiaries are helpful
in our considerations.
Proposed Assignment of ``Permanent'' or ``Provisional'' Status to a
Service and Changes in Status
We proposed to assign ``permanent'' or ``provisional'' status to
any services for which the service elements map to the service elements
of a service on the list that has a permanent status described in
previous final rulemaking (see proposed step 4) or for which there is
evidence of clinical benefit analogous to the clinical benefit of the
in-person service when the service is furnished via telehealth by an
eligible Medicare telehealth physician or practitioner (see proposed
step 5). These two designations (that is, ``permanent'' or
``provisional'') are intended to replace the Category 1-3 taxonomy that
CMS currently uses. This proposed change is intended to reduce
confusion regarding the status of codes on the Medicare Telehealth
Services List and to simplify the outcome of our analysis. After a code
receives the ``provisional'' status, as evidence generation builds, we
may assign ``permanent'' status in a future year, or we may remove the
service from the list in the interest of patient safety based on
findings from ongoing monitoring of telehealth services within CMS and
informed by publicly available information. We would revisit
provisional status through our regular annual submissions and
rulemaking processes where a submission provides new evidence, or our
claims monitoring shows anomalous activity, or as indicated by patient
safety
[[Page 78865]]
considerations. CMS would handle changes in status by revisiting the
same steps 1 through 5 above.
Summary and Request for Feedback on Proposals To Update the Process of
Review for Adding, Removing, or Changing the Status of Services on the
Medicare Telehealth List
In the proposed rule, we noted that the timeline for our proposed
process to analyze submissions would remain the same. CY 2025
submissions would be due by February 10, 2024. Additionally, we would
continue to address each submitted request for addition, deletion, or
modification of services on the Medicare Telehealth Services List
through annual notice and comment rulemaking.
As the end of the PHE for COVID-19 was uncertain at the time of
last year's rule, many of the submissions for both CY 2023 and CY 2024
involved requests to change the status of services on the Medicare
Telehealth Services List from temporary to permanent. In other words,
many requestors requested that CMS consider changing the status of one
or more services from Category 3 to Category 1 or 2. Based on the
number of requests we received asking that CMS assign a different
status to a given service, we believe a clarification is necessary to
remind readers of the steps that we take when analyzing a given service
for addition to, removal from, or a change in status on the Medicare
Telehealth Services List. Through this proposal, we intended to refine
our process and reduce confusion going forward.
To reiterate some of our discussion above, our proposals are
consistent with the existing principles that CMS has applied to
requests to add, remove, or change the status of a code during the
COVID-19 PHE. When reviewing submissions during the PHE, in the absence
of evidence supporting clinical benefit, but public comment expressing
support for possible clinical benefit, CMS would generally accept a
temporary addition to the Medicare Telehealth Services list, allowing
more time for evidence generation. We anticipated that our approach
would generally remain consistent with this particular point of
flexibility if this proposal were finalized; a code could potentially
receive provisional status on the Medicare Telehealth Services List in
such a situation, with the caveat that our proposed Steps 1, 2, and 3,
are thresholds for inclusion on the Medicare Telehealth Services List.
If CMS finds that a service is not separately payable under the PFS
(see proposed step 1) or it is not subject to section 1834(m) of the
Act (see proposed Step 2), that service would not be added to the
Medicare Telehealth Services List on any basis (and notice of the
rejection would be provided to the submitter, as noted above). We do
not intend to reject a submission based solely on the fact that the
requestor did not request the appropriate basis for consideration; we
would still analyze the submission based on the proposed steps, and
then we would propose to add, remove, or change the status of the
service, or we would explain why we were not doing so.
We received comments on our proposed analysis procedures for
additions to, removals from, or changes in status for services on the
Medicare Telehealth Services List. The following is a summary of the
comments we received and our responses.
Comment: Overall, commenters agreed with our proposal. Many
commenters expressed general support for our proposal to simplify our
process for managing updates to the telehealth list. We did not receive
any comments that requested CMS delay or forgo the proposed changes.
Some commenters requested more clarity about the timing of updates and
requested greater visibility into determinations of permanent or
provisional services. Several commenters expressed concern that a
static list may not be able to keep pace with innovation or asserted
that CMS has not gone far enough with its temporary services policies
to allow room for experimentation.
Response: We note that our flexibility to make subregulatory
changes to the Medicare Telehealth Services List expired at the end of
the PHE. As a result, CMS must effectuate any change to the list
through notice and comment rulemaking. Further, as we explained in our
restatement of the longstanding criteria in this year's proposed rule,
the points of evaluation, and timing of review period, both remain
unchanged under our proposal. However, we believe modifications to our
procedures may result in less confusion. Study and observation of these
services in clinical practice add to available evidence, thereby
continuing to address gaps in evidence. A revised process lends greater
opportunity to focus on evidence generation. Whether a service has an
appropriate valuation or whether a clinical action is appropriate as
described in the service itself are not open questions, so submissions
need not take up those questions. The matter at hand, is whether audio-
video communication can fully substitute in-person interactions and
still complete the service while providing clinical benefit.
Submissions should include verifiable and transparent studies that
compare the typical beneficiary populations who receive the in-person
service versus the telehealth service, and set forth methods, analysis,
observations, and conclusions that address any differences in receiving
in-person versus telehealth service.
Comment: Some commenters suggested that CMS need not go beyond Step
3 to determine whether a service should be included on the list. One
commenter requested clarification as to whether Step 3 requires,
``substantial clinical improvement.''
Response: We disagree with commenters that only Steps 1-3 are
necessary and remind readers that section 1834(m)(4)(F)(ii) of the Act
requires that the Secretary establish a process that provides, on an
annual basis, for the addition or deletion of services (and HCPCS
codes), to the definition of telehealth services for which payment can
be made when furnished via telehealth under the conditions specified in
section 1834(m) of the Act. Since we added many services to the
Medicare Telehealth List during the PHE, maintaining any of these
additional services after the PHE would become difficult to administer
in future years without Steps 4 and 5 (or something analogous) because
Steps 1-3 only consider whether 1834(m) may apply, whereas later steps
help us decide whether there is clinical benefit for a service when
face-to-face interactions are substituted with the use of two-way
audio-video communications technology.
Stopping at Step 3 would leave us without some basis that the full
service could be performed without fundamentally changing the design,
meaning, and RVUs already established in making the code payable under
the PFS, for any given code we review for consideration on our Medicare
Telehealth List. Analysis of the effects of complete substitution of
any and all of the otherwise in-person elements in a given code happens
in two ways. If the individual code is so similar to the statutorily
enumerated codes described in section 1834(m) of the Act, then the code
may be added without further examination (that is, without Step 4).
Responsive to concerns that the review process may not keep pace
with innovation, we disagree that Steps 4 and 5 threaten innovation. We
also do not believe that the update and review process for the Medicare
Telehealth List should be the driver for innovation. We note this Step
3 analysis is different from any substantial clinical improvement
analysis. Our process is
[[Page 78866]]
intended to strike a balance between the uncertainty of innovation,
which may not be well-accounted for in the framework of section 1834(m)
of the Act, with our recent history of regulations promulgated to
implement the statutory requirements of section 1834(m) of the Act.
Comment: A few commenters expressed concern that we have hesitated
or declined to extend telehealth flexibilities over the past 3 years
and have added significant qualifiers, including in-person
requirements, to mental health services. Other commenters expressed
concern that maintaining the PHE flexibilities may interfere with the
doctor-patient relationship or create the unintended consequence of
reducing access and clinical benefits of in-person care. There remains
a diversity of opinions across various interested parties.
Response: We note that CMS has implemented a broad range of
telehealth flexibilities and related policies to expand access to
services and address gaps in care, including a focus on expanding
access to behavioral health. We believe it is important to note that
Congress mandated the in-person requirements for Medicare telehealth
services for diagnosis, evaluation, or treatment of a mental health
disorder through the CAA, 2021, and has twice delayed the requirement
in the CAA, 2022 and CAA, 2023. As a result, we have not yet enforced
the in-person requirement for telehealth services for diagnosing,
evaluating, or treating a mental health disorder.
We are finalizing, as proposed, our consolidation of categories for
services currently on the Medicare Telehealth List, as described in the
following section.
d. Consolidation of the Categories for Services Currently on the
Medicare Telehealth Services List
We also proposed consolidating Categories 1, 2, and 3, as proposed
above, for all services currently on the Medicare Telehealth Services
List. For CY 2024, we proposed to redesignate any services that are
currently on the Medicare Telehealth Services List on a Category 1 or 2
basis and would be on the list for CY 2024 to the proposed new
``permanent,'' category while any services currently added on a
``temporary Category 2'' or Category 3 basis would be assigned to the
``provisional'' category. We believe redesignations in this calendar
year would help ease confusion in future years, including in the event
of subsequent legislation regarding Medicare telehealth services.
Furthermore, for a code that receives provisional status, as
evidence generation builds, we may grant the code a permanent status in
a future year or remove the service from the list in the interest of
patient safety based on findings from ongoing monitoring of telehealth
services within CMS and informed by publicly available information. Our
proposal did not set any specific timing for reevaluation of services
added to the Medicare Telehealth Services List on a provisional basis
because evidence generation may not align with a specific timeframe.
Our proposal not to establish any specific timing for considering
changes from provisional to permanent status avoids a potential
situation in which we must remove provisional services from the
Medicare Telehealth Services List because the set period tolls, only to
later find evidence demonstrating that the removed service should
receive permanent status. Under our proposal, we would assign a
provisional status for codes that satisfy the proposed threshold steps
(1, 2, and 3), and then the evidence available leaves a ``close call''
between permanent and provisional status. We do not assign provisional
status when it is improbable that the code would ever achieve permanent
status.
We received comments on our proposal to consolidate categories for
services currently on the Medicare Telehealth List. The following is a
summary of the comments we received and our responses.
Comment: Overall, commenters expressed support for our proposal to
consolidate categories for services currently on the list. Some
commenters requested that CMS set a specific timing, with more
transparency about the change in status of provisional codes.
Commenters also asserted that CMS should broaden its narrow
interpretation of the requirements of section 1834(m) of the Act. Many
commenters referenced the CONNECT for Health Act, HR 3875/S. 2016
(refer to congress.gov/bill/118th-congress/house-bill/3875/committees?s=1&r=38).
Response: We reiterate our discussion of timing and note that CMS
has no plans to remove any provisional service from the current
telehealth list where evidence generation remains in-process, and the
individual code is subject to section 1834(m) of the Act. We would
remove a provisional service from the list if evidence demonstrated
patient safety issues. Our consideration of provisional services
requires us to balance the statutory requirements of section 1834(m) of
the Act with the availability of clinical evidence. The statutory and
clinical research landscapes may change on a different timing and
cadence.
Regarding the timing and change in status of a provisional code to
a permanent code, this change in status would depend on a few factors.
For example, if we become aware of updated clinical guidelines
reflecting changes that show it is appropriate for the Medicare
population to receive a telehealth service identified as provisional,
then we would consider that evidence as support for a potential change
from provisional to permanent status. For further background, we refer
readers to the section that follows. We disagree with commenters who
suggested that our interpretation of section 1834(m) of the Act is
excessively narrow.
We believe it remains important to underscore that the purpose of
designations of permanent versus provisional services on the Medicare
Telehealth List is to signal where more study is necessary while
avoiding the unintended consequence where a change in status itself
drives the formation of new clinical standards or practices.
Table 11 lists codes we are finalizing for the Medicare Telehealth
Services List and includes the simplified categorization of each
service as either provisional or permanent. The provisional services
are those that are currently temporary, while the permanent services
are those that are currently permanent as category 1 or 2. As in
Medicare Telehealth Services Lists included in previous PFS final rules
and posted on our website at https://www.cms.gov/medicare/coverage/telehealth/list-services, the audio-only column designates those
services that may be furnished using audio-only technology, including
telehealth services for mental health (including SUD). We are
finalizing our proposal to use the simplified ``provisional'' or
``permanent'' designations for the current year, and to apply our
revised review process beginning with reviews for the CY 2025 PFS
proposed rule.
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e. Implementation of Provisions of the CAA, 2023
(1) Overview and Background
The CAA, 2022 included several provisions that extend certain
Medicare telehealth flexibilities adopted during the COVID-19 PHE for
151 days after the end of the PHE. Specifically, sections 301 through
305 of Division P, Title III, Subtitle A of the CAA, 2022 amended
section 1834(m) of the Act to generally extend certain PHE-related
telehealth policies for services that were on the Medicare Telehealth
Services List as of the date of enactment (March 15, 2021). The CAA,
2022, temporarily removed restrictions on telehealth originating sites
for those services to allow telehealth services to patients located in
any site in the United States at the time of the telehealth service,
including an individual's home;
[[Page 78872]]
expanded the definition of telehealth practitioners to include
qualified occupational therapists, qualified physical therapists,
qualified speech-language pathologists, and qualified audiologists;
continued payment for telehealth services furnished by FQHCs and RHCs
using the methodology established for those telehealth services during
the PHE; delayed the requirement for an in-person visit with the
physician or practitioner within 6 months prior to initiating mental
health telehealth services to a beneficiary in their home, and again at
subsequent intervals as the Secretary determines appropriate, as well
as similar requirements for RHCs and FQHCs; and continued to provide
for payment of telehealth services included on the Medicare Telehealth
Services List as of the March 15, 2020, that are furnished via an
audio-only telecommunications system. A full discussion of these
policies available in the CY 2023 PFS final rule at 87 FR 69462.
In addition, section 309 of the CAA, 2022 authorized the Secretary
to implement the amendments described above, made by sections 301
through 305, through program instruction or otherwise. In the CY 2023
PFS final rule (87 FR 69446), we finalized specific telehealth policies
to conform to and align with amendments made by the CAA, 2022. In our
CY 2023 PFS final rule (87 FR 69462-69464), we described how CMS would
issue program instructions to implement specific requirements of the
CAA, 2022. We also implemented the provisions enacted in the CAA, 2022
for a 151-day extension period of certain telehealth flexibilities
(discussed previously in this final rule). On December 29, 2022, the
President signed the CAA, 2023 into law. Section 4113 of the CAA, 2023
further extends the previously-extended PHE-related telehealth
policies; it requires CMS to extend the telehealth flexibilities that
were previously extended (initially for 151 days after the end of the
PHE) under the CAA, 2022, through December 31, 2024.
We seek to address various telehealth policies that we finalized in
the CY 2023 final rule, in light of the CAA, 2023. For example, the
151-day extension period for certain flexibilities discussed in our CY
2023 final rule (and previously in this final rule) no longer applies,
since section 4113 of the CAA, 2023 extends these flexibilities until
December 31, 2024 (the extended flexibilities include: temporary
expansion of the scope of telehealth originating sites for services
furnished via telehealth to include any site in the United States where
the beneficiary is located at the time of the telehealth service,
including an individual's home; expansion of the definition of eligible
telehealth practitioners to include qualified occupational therapists,
qualified physical therapists, qualified speech-language pathologists,
and qualified audiologists; continued payment for telehealth services
furnished by FQHCs and RHCs using the methodology established for those
telehealth services during the PHE; delaying the requirement for an in-
person visit with the physician or practitioner within 6 months prior
to initiating mental health telehealth services, and again at
subsequent intervals as the Secretary determines appropriate, as well
as similar requirements for RHCs and FQHCs; and continued coverage and
payment of telehealth services included on the Medicare Telehealth
Services List as of March 15, 2020) until December 31, 2024. Both the
CAA, 2022 and CAA, 2023 have the same operative effect on the scope of
Medicare telehealth services; both the CAA, 2022 and CAA, 2023 give the
Secretary the authority to implement the relevant telehealth provisions
outside of notice and comment rulemaking through program instruction or
otherwise. We intend to implement the provisions discussed above, as
enacted by the CAA, 2023.
Similar to the goals of our telehealth policies addressed in last
year's final rule, for CY 2024, we again seek to retain payment
stability, reduce confusion, and burden, and conform to all statutory
requirements without unnecessary restrictions on beneficiaries' access
to telehealth care. Our discussion here does not alter payment amounts
or billing rules that are in effect as of January 1, 2023, and those
policies will remain in effect through December 31, 2024. Instead, it
is our intent in this final rule to clarify that certain telehealth
flexibilities that were previously extended until 151 days after the
end of the PHE, by the CAA, 2022, have been extended until December 31,
2024, in accordance with the amendments made by provisions of the CAA,
2023.
(2) In-Person Requirements for Mental Health Telehealth
Section 4113(d)(1) of section FF, Title IV, Subtitle B of the CAA,
2023 amends section 1834(m)(7)(B)(i) of the Act to delay the
requirement for an in-person visit with the physician or practitioner
within 6 months prior to the initial mental health telehealth service,
and again at subsequent intervals as the Secretary determines
appropriate. In light of this amendment, the in-person requirements for
telehealth services furnished for purposes of diagnosis, evaluation, or
treatment of a mental health disorder will again be effective on
January 1, 2025. In addition, 4113(d)(2) of section FF, Title IV,
Subtitle B of the CAA, 2023 modified sections 1834(y) and 1834(o)(4) of
the Act, respectively, to similarly delay in-person visit requirements
for mental health visits furnished by Rural Health Clinics and
Federally Qualified Health Centers via telecommunications technology.
Therefore, we proposed to revise the regulatory text at Sec.
[thinsp]410.78(b)(3)(xiv) and (b)(4)(iv)(D) to recognize the delay of
the in-person requirements for mental health visits furnished by RHCs
and FQHCs through telecommunication technology under Medicare until
January 1, 2025, rather than until the 152nd day after the end of the
PHE, to conform with the CAA, 2023. See section III.B. of this final
rule for our provision to implement similar changes for RHC and FQHC
mental health visits.
We received public comments on the proposal to delay in-person
requirements for mental health telehealth. The following is a summary
of the comments we received and our responses.
Comment: Some commenters supported our proposals to extend the
delay of in-person requirements for mental health telehealth. We
received many form letters in a coordinated response from state health
organizations that requested we make the delay permanent. Some
commenters highlighted that recent data suggest that even in complex
patients with significant behavioral health issues, virtual-only care
does not result in worse outcomes. The feedback also cited findings of
significant behavioral healthcare workforce shortages that are likely
to persist.\5\
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\5\ Many commenters made general statements about shortages
without specific studies or data. We did receive form letter
responses with various sources for statistic, and some with sources
unavailable. CMS staff found the following resource referenced in
some comments, but at a different location. ``In 2021, health
centers employed 17,415 full-time behavioral health staff, with
psychiatrists and licensed clinical psychologists making up 10% of
that workforce at 5% each. Document at https://www.nachc.org/wp-content/uploads/2023/07/Community-Health-Center-Chartbook-2023-2021UDS.pdf.
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Response: We thank commenters for the feedback. We understand why
some commenters might want us to extend the delay of in-person
requirements for mental health telehealth permanently, but we remind
commenters that we are simply revising the regulations to conform to
the requirements in section
[[Page 78873]]
4113(d) of section FF, title IV, Subtitle B of the CAA, 2023, which
only delays in-person requirements for telehealth services furnished
for purposes of diagnosis, evaluation, or treatment of a mental health
disorder through the end of CY 2024.
Comment: Some commenters stated that CMS should implement the in-
person requirements when the delay mandated by the CAA, 2023 expires.
One life sciences company expressed concern that in absence of regular
in-person care, practitioners may not appropriately manage therapy
regimens for patients who receive medication to treat certain mental
health conditions. A State-wide medical professional organization with
a significant rural population cautioned against further delay of
requirements and noted concern that direct-to-consumer telehealth
entities may be engaging with beneficiaries in ways that raise
concerns.\6\ One commenter stated that an indefinite delay of in-person
requirements may risk communication benefits that come with in-person
interactions important in the Medicare population.\7\
---------------------------------------------------------------------------
\6\ The commenter included a link to investigative journalism
focused on the issue, available at https://www.codastory.com/
waronscience/pseudohealth/telehealth-companies-misinformation/
#:~:text=Bypassing%20traditional%20healthcare,your%20health%20itself.
\7\ The commenters referenced recent peer-reviewed literature
available at https://journals.sagepub.com/doi/full/10.1177/10748407211031980.
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Response: We thank commenters for the feedback, and we direct them
to the statutory requirements specified in the CAA, 2023 and described
in further detail previously in this section.
We are finalizing as proposed our policy to delay in-person
requirements for telehealth behavioral health services until January 1,
2025.
We remind suppliers of behavioral health services who furnish
telehealth services to beneficiaries for purposes of diagnosis,
treatment, and management of behavioral health conditions (including
SUD), that the in-person requirements for behavioral telehealth
services set forth in our regulations at Sec. 410.78(b)(3)(xiv) are
set to take effect beginning for CY 2025. Section 410.78(b)(3)(xiv)(A)
requires that the initial telehealth service shall be furnished only
after an in-person visit within 6 months of the initial telehealth
service; Sec. 410.78(b)(3)(xiv)(B) requires that any subsequent
telehealth service, that is, for established patients with both a prior
in-person visit, and an initial telehealth visit, must be furnished
only when the beneficiary has received an in-person service no longer
than 12 months prior; and Sec. 410.78(b)(3)(xiv)(B) provides
flexibility to recognize beneficiary preferences, including that
concerns of privacy or other burdens and risks may dictate a longer
interval between the most recent in-person visit and a subsequent
telehealth visit, when circumstances dictate an exception, the
documentation substantiating the need for such an exception must be
documented in the medical record; and Sec. 410.78(b)(3)(xiv)(C)
specifies that either in-person requirement (initial or subsequent) may
be met by another practitioner of the same specialty and subspecialty
in the same group as the practitioner that furnishes the telehealth
services only when the practitioner who furnishes the telehealth
service is not available.
We reiterate rules that we finalized and discussed at length in
previous rulemaking (87 FR 69463 and 69464; 86 FR 65055 through 65059),
in response to some confusion expressed by commenters on the scope of
the in-person requirements, and divergent views on possible unintended
consequences of maintaining or eliminating the in-person requirements.
The regulations at Sec. 410.78(b)(3)(xiv) describe two exceptions to
the in-person requirements that will go into effect on January 1, 2025:
beneficiaries who already receive telehealth behavioral health services
and have circumstances where in-person care may not be appropriate
would have an exception and groups with limited availability for in-
person behavioral health visits would have available the flexibility to
arrange for practitioners to furnish in-person and telehealth visits
with different practitioners, based on availability.
(3) Originating Site Requirements
Section 4113(a)(2) of the CAA, 2023 amended section
1834(m)(4)(C)(iii) of the Act to temporarily expand the telehealth
originating sites for any service on the Medicare Telehealth Services
List to include any site in the United States where the beneficiary is
located at the time of the telehealth service, including an
individual's home, beginning on the first day after the end of the PHE
for COVID-19 through December 31, 2024. The list of telehealth
originating sites remains as listed in our regulation at Sec.
410.78(b)(3).
We received public comments on the proposal to temporarily expand
telehealth originating sites to include the patient's home, for any
non-mental health telehealth service on the Medicare Telehealth
Services List through December 31, 2024. The following is a summary of
the comments we received and our responses.
Comment: Commenters urged CMS to maintain the definition of ``the
patient's home'' under Sec. 410.78(b)(3) to broadly include homeless
shelters, group homes, or other settings that the beneficiary
identifies as their home or residence, whether permanent or temporary.
Response: As discussed in the CY 2022 PFS final rule (FR 86 65059),
our definition of home, both in general and for this purpose, continues
to include temporary lodging such as hotels and homeless shelters. As
stated in that final rule, for circumstances where the patient, for
privacy or other personal reasons, chooses to travel a short distance
from the exact home location during a telehealth service, the service
is still considered to be furnished ``in the home of an individual''
for purposes of section 1834(m)(4)(C)(ii)(X) of the Act.
Comment: We received many comments that requested CMS clarify
policies related to, but separate from, our originating site proposals.
Commenters expressed concerns regarding the expiring flexibility for
telehealth practitioners to use their currently enrolled location
instead of their home address when providing 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 through December 31, 2023. We also met
with a coalition of interested parties to receive feedback on this
particular issue, during the comment period. The interested parties
suggested that expiration of this flexibility poses a potential and
imminent threat to public safety (that is, the safety of the health
care workforce). In these comments and our meeting with the coalition,
interested parties voiced concerns about the safety and privacy of
health professionals who work from home and furnish telehealth
services. Commenters requested that CMS take steps to protect
telehealth practitioners by adjusting enrollment requirements so that
individual practitioners did not have to list their home addresses on
enrollment forms. The commenters also cited recent examples of
workplace violence in health care facilities, where direct harm to
nurses and other medical staff occurred. As an additional
consideration, interested parties explained that a significant number
of practices and providers would need to change billing practices or
add their home address to the Medicare enrollment file, coordinating
with the
[[Page 78874]]
appropriate Medicare Administrative Contractor in their jurisdiction.
Response: We thank commenters for bringing this issue to our
attention. Through CY 2024, we will continue to permit the distant site
practitioner to use their currently enrolled practice location instead
of their home address when providing telehealth services from their
home. We will also consider this issue further for future rulemaking
and request that interested parties provide clear examples of how the
enrollment process shows material privacy risks to inform future
enrollment and payment policy development. We request further
information from interested parties to better understand the scope of
considerations involved with including a practitioner's home address as
an enrolled practice location when that address is the distant site
location where they furnish Medicare telehealth services.
(4) Telehealth Practitioners
Section 4113(b) of the CAA, 2023 amends section 1834(m)(4)(E) of
the Act to require that qualified occupational therapists, qualified
physical therapists, qualified speech-language pathologists, and
qualified audiologists continue to be included as telehealth
practitioners beginning on the first day after the end of the PHE for
COVID-19 through December 31, 2024. Therefore, the list of telehealth
practitioners remains as described in our CY 2023 final rule. We will
also recognize marriage and family therapists (MFT) and mental health
counselors (MHC) as telehealth practitioners, effective January 1,
2024, in accordance with amendments made by section 4121 of the CAA,
2023. That section of the CAA, 2023 amends section 1861(s)(2) of the
Act by adding a new subparagraph (II) that establishes a new benefit
category under Part B for marriage and family therapist services (as
defined in section 1861(lll)(1)) of the Act and mental health counselor
services (as defined in section 1861(lll)(3) of the Act). Further,
section 4121(a)(5) of the CAA, 2023 amended section 1842(b)(18)(C) of
the Act to add MFTs and MHCs to the list of practitioners to whom
Medicare payment may be made for their services on a reasonable charge
or fee schedule basis only on an assignment-related basis. Because the
definition of practitioners in section 1834(m)(4)(E) of the Act for
purposes of Medicare telehealth services includes the practitioners
described in section 1842(b)(18)(C) of the Act, this provision also has
the effect of adding MFTs and MHCs as practitioners who can furnish
telehealth services.
We proposed to amend Sec. 410.78(b)(2) to add new paragraphs (xi)
and (xii) to specify that a marriage and family therapist as described
in proposed Sec. 410.53 and a mental health counselor as described in
proposed Sec. 410.54 are included as distant site practitioners for
purposes of furnishing telehealth services.
We received public comments on the proposal to permanently add MFTs
and MHCs as distant site practitioners for purposes of furnishing
telehealth services. The following is a summary of the comments we
received and our responses.
Comment: Commenters expressed support for our proposals.
Response: After consideration of public comments, we are finalizing
our proposal to add MFTs and MHCs as distant site practitioners for
purposes of furnishing telehealth services. We are finalizing our
proposed amendments to add MFTs and MHCs to the list of distant site
practitioners in the telehealth regulation at Sec.
410.78(b)(2)(xi),(xii).
(5) Audio-Only Services
Section 4113(e) of Division FF, Title IV, Subtitle C of the CAA,
2023 amends section 1834(m)(9) of the Act to require that the Secretary
shall continue to provide for coverage and payment of telehealth
services via an audio-only communications system during the period
beginning on the first day after the end of such emergency period and
ending on December 31, 2024. This provision applies only to telehealth
services specified on the Medicare Telehealth Services List under
section 1834(m)(4)(F)(i) of the Act that are permitted to be furnished
via audio-only technology as of the date of enactment of the CAA, 2023
(that is, December 29, 2022).
As discussed below in the section titled ``Other Clarifications for
Appropriate Billing,'' CPT codes 99441 through 99443 are on the
Medicare Telehealth Services List and will remain actively priced
through 2024. We proposed to continue to assign an active payment
status to CPT codes 98966 through 98968 for CY 2024.
e. Place of Service for Medicare Telehealth Services
When a physician or practitioner submits a claim for their
professional services, including claims for telehealth services, they
include a Place of Service (POS) code that is used to determine whether
a service is paid using the facility or non-facility rate. Under the
PFS, there are two payment rates for many physicians' services: the
facility rate, which applies when the service is furnished in hospital
or skilled nursing facility (SNF) setting, and the non-facility rate,
which applies when the service is furnished in an office or other
setting. The PFS non-facility rate is the single geographically
adjusted fee schedule amount paid to a physician or other practitioner
for services furnished in their office or other non-facility outpatient
setting. The PFS facility rate is the single, geographically adjusted
amount paid to a physician or other practitioner when a service is
furnished in a hospital or SNF setting where Medicare is making a
separate payment for the services to the facility in addition to the
payment to the billing physician or practitioner for their professional
services. This separate payment to the facility (hospital or SNF),
often referred to as a ``facility fee,'' is made under other payment
systems and reflects the facility's costs associated with the service
(clinical staff, supplies, equipment, overhead) and is paid in addition
to what is paid to the professional under the PFS.
Prior to CY 2017, Medicare telehealth services were reported using
the GT modifier. In the CY 2017 PFS final rule, we finalized creation
of a new Place of Service (POS) code to identify services furnished as
Medicare telehealth services, POS ``02'' (81 FR 80199-80201). In the CY
2022 PFS final rule, we created a new POS code ``10'' to identify
Medicare telehealth services for which the patient's home is the
originating site (87 FR 70110 and 70111).
In response to the PHE for COVID-19, we adopted temporary policies
for POS codes and PFS payment rates applicable to Medicare telehealth
services. As discussed in the March 31, 2020 IFC, (85 FR 19230), we
stated that, as physician practices suddenly transitioned a potentially
significant portion of their services from in-person to telehealth
visits in the context of the PHE for COVID-19, the relative resource
costs of furnishing these services via telehealth may not significantly
differ from the resource costs involved when these services are
furnished in-person. Therefore, we instructed physicians and
practitioners who billed for Medicare telehealth services to report the
POS code that they would have reported had the service been furnished
in-person. This would allow our systems to make appropriate payment for
services furnished via Medicare telehealth, which, if not for the PHE
for COVID-19, would have been furnished in-person, at the same rate
they would have been paid if the services were furnished in-person. In
order to effectuate this
[[Page 78875]]
change, we finalized on an interim basis (85 FR 19233) the use of the
CPT telehealth modifier, modifier ``95'', for the duration of the PHE
for COVID-19, which is applied to claim lines that describe services
furnished via telehealth; and that the practitioner should report the
POS code where the service would have occurred had it not been
furnished via telehealth. This allowed telehealth services to be paid
at the PFS non-facility rate.
We further noted that we were maintaining the facility payment rate
for services billed using the general telehealth POS code ``02'',
should practitioners choose to maintain their current billing practices
for Medicare telehealth during the PHE for COVID-19. In the CY 2023 PFS
final rule (87 FR 69467), we finalized that we would continue to
maintain payment at the rate for a service had the service been
furnished in person, and that this would allow payments to continue to
be made at the non-facility based rate for Medicare telehealth services
through the latter of the end of CY 2023 or the end of the calendar
year in which the PHE ends.
In the CY 2023 PFS final rule (87 FR 69467), we finalized that,
following the end of the end of the calendar year in which the PHE
ends, practitioners will no longer bill claims with Modifier `95' along
with the POS code that would have applied had the service been
furnished in person, and telehealth claims will instead be billed with
the POS indicators:
POS ``02''--is redefined as Telehealth Provided Other than
in Patient's Home (Descriptor: The location where health services and
health related services are provided or received, through
telecommunication technology. Patient is not located in their home when
receiving health services or health related services through
telecommunication technology.); and
POS ``10''--Telehealth Provided in Patient's Home
(Descriptor: The location where health services and health related
services are provided or received through telecommunication technology.
Patient is located in their home (which is a location other than a
hospital or other facility where the patient receives care in a private
residence) when receiving health services or health related services
through telecommunication technology.).
We recognize that, beginning with the PHE for COVID-19, behavioral
health services that otherwise would have been furnished in-person have
been furnished via telehealth in the patient's home. With few
exceptions, prior to the PHE for COVID-19, originating sites were
limited to sites such as physician's offices and hospitals. Now that
behavioral health telehealth services may be furnished in a patient's
home, which now may serve as an originating site, we believe these
behavioral health services are most accurately valued the way they
would have been valued without the use of telecommunications
technology, namely in an office setting. There was an increase in
utilization of these mental health services during the PHE that has
persisted throughout and after expiration of the PHE for COVID-19. It
appears that practice patterns for many mental health practitioners
have evolved, and they are now seeing patients in office settings, as
well as via telehealth. As a result, these practitioners continue to
maintain their office presence even as a significant proportion of
their practice's utilization may be comprised of telehealth visits. As
such, we stated that we believe their practice expense (PE) costs are
more accurately reflected by the non-facility rate.
Therefore, we proposed that, beginning in CY 2024, claims billed
with POS 10 (Telehealth Provided in Patient's Home) would be paid at
the non-facility PFS rate. When considering certain practice situations
(such as in behavioral health settings, where practitioners have been
seeing greater numbers of patients via telehealth), practitioners will
typically need to maintain both an in-person practice setting and a
robust telehealth setting. We expect that these practitioners will be
functionally maintaining all of their PEs, while furnishing services
via telehealth. When valuing services, we believe that there are few
differences in PE when behavioral health services are furnished to a
patient at home via telehealth as opposed to services furnished in-
person (that is, behavioral health settings require few supplies
relative to other healthcare services). Claims billed with POS 02
(Telehealth Provided Other than in Patient's Home) will continue to be
paid at the PFS facility rate beginning on January 1, 2024, as we
believe those services will be furnished in originating sites that were
typical prior to the PHE for COVID-19, and we continue to believe that,
as discussed in the CY 2017 PFS final rule (81 FR 80199 through 80201),
the facility rate more accurately reflects the PE of these telehealth
services; this applies to non-home originating sites such as
physician's offices and hospitals. In this way, we believe we would be
protecting access to mental health and other telehealth services by
aligning with telehealth-related flexibilities that were extended via
the CAA, 2023, as we will be more accurately recognizing the resource
costs of behavioral health providers, given shifting practice models.
We received public comments on the proposal that claims billed with
POS 10 be paid at the non-facility PFS rate, and claims billed with POS
02 will continue to be paid at the facility rate. The following is a
summary of the comments we received and our responses.
Comment: Many commenters stated that our proposal would enhance
patient access and protect payment parity. Other commenters supported
paying claims billed with POS 10 at the non-facility rate but opposed
maintaining payment for claims billed with POS 02 at the facility rate,
stating that this will reduce access to telehealth services by
disincentivizing office-based practices by paying a lower PE RVU in
instances where there is a site of service differential. A few
commenters opposed paying the non-facility rate for any telehealth
service, stating that the facility rate more accurately reflects the
resource-based costs of telehealth services. Some commenters urged us
to continue allowing practitioners to report the POS code that they
would have used had the service been furnished in person. One commenter
urged us to gather more data on the PE resource costs associated with
telehealth services for a range of services before paying the higher,
non-facility rate; this commenter stated that if rates for telehealth
services continue to be set equal to rates for in-office services,
providers may face a strong financial incentive to favor these services
over comparable in-person services, even when an in-person service may
be more clinically appropriate. A commenter requested that CMS wait
until the potential implementation of the telemedicine codes that CPT
is considering for 2025 until revising the current place of service
policy for telehealth services.
Response: Telehealth services that are not furnished in the
patient's home will continue to be furnished in the same types of
originating sites in which they were furnished prior to the PHE, such
as hospitals or rural health clinics; therefore, the resource costs
associated with these services will resemble those of services
furnished in person in a facility setting as they did prior to the PHE.
As discussed in the 2017 final rule (81 FR 80199-80200), for telehealth
services, we believe that facility costs (clinical staff, supplies, and
equipment) associated with furnishing the service would generally be
incurred by the originating site, where the patient is located, and not
by the practitioner at
[[Page 78876]]
the distant site. The statute requires Medicare to pay a fee to the
site that hosts the patient. This is analogous to the circumstances
under which the facility PE RVUs are used to pay for services under the
PFS. That is why we believe that the facility PE RVUs most accurately
reflect the resource costs for telehealth services when the home is not
the originating site. We note that beginning in 2025, most telehealth
services will once again be subject to the statutory restrictions under
section 1834(m)(4), including the limitation on payment for telehealth
services to those furnished in specified originating sites and in areas
that are designated as a rural health professional shortage area or in
a county that is not included in a Metropolitan Statistical Area and to
sites that are certain medical facilities such as physician offices,
hospitals, and skilled nursing facilities. Following 2024, mental
health telehealth services, as previously noted, as well as certain
other services including End-Stage Renal Disease (ESRD)-related
services for home dialysis, will continue to be paid when furnished in
the patient's home without geographic restrictions. They will more
likely be furnished by office-based mental health practitioners.
Practitioners furnishing mental health services via telehealth will
more typically be practicing in non-facility based settings, rather
than in facility settings that are associated with originating sites
that were eligible originating sites prior to the addition of the home
as an originating site, and they are therefore more likely to have
office-based practices and so are incurring all of those resource
costs. Beginning in 2025, in-person visit requirements will apply for
mental health services furnished via telehealth. This includes a
required in-person visit within the six months prior to the initial
telehealth treatment as well as the requirement that subsequent in-
person visits be furnished at least every 12 months. Therefore, mental
health practitioners necessarily will be maintaining offices as they
will be required to have in-person visits, and we believe they will be
incurring the PE costs of maintaining these hybrid models. We also note
that claims data indicate that during the PHE, the majority of mental
health services that were furnished via telehealth were billed with the
POS associated with the office setting. We believe that for mental
health services furnished via telehealth, resource costs will be
incurred by the distant site provider, where the practitioner is
located, and not by the originating site, unlike other telehealth
services for which we believe the resource costs will continue to be
incurred by the originating site, where the patient is located, and not
by the practitioner at the distant site. Therefore, we continue to
believe that paying for claims billed with POS 10 at the non-facility
rate while continuing to pay for claims billed with POS 02 at the
facility rate most accurately captures the resource costs inherent in
these types of telehealth visits.
Comment: A commenter requested that CMS clarify that CMS will pay
the PFS non-facility rate for any service appended with POS 10, not
just mental health services.
Response: We clarify that any service appropriately billed with POS
10 will be paid at the non-facility rate.
Comment: A few commenters requested that CMS clarify the
appropriate billing and payment for telehealth services when the
clinician is in the hospital and the patient is in the home, and
whether we require that facility-based clinicians should report POS 02.
Response: We wish to clarify that for telehealth services, when the
clinician is in the hospital and the patient is in the home, the
billing practitioner should use a hospital POS code along with modifier
`95.'
Comment: Some commenters requested that CMS confirm that all
outpatient therapy telehealth services will continue to be paid at the
non-facility rate regardless of the POS code, citing manual language in
Chapter 12 Section 20.4.2 that states: ``Non-facility rates are
applicable to outpatient rehabilitative therapy procedures, including
those relating to physical therapy, occupational therapy and speech-
language pathology, regardless of whether they are furnished in
facility or non-facility settings.''
Response: We wish to clarify that, for outpatient therapy services
furnished via telehealth by PT, OT, or SLP distant site practitioners,
the furnishing practitioner should continue to append the 95 modifier
to identify them as telehealth services rather than a telehealth POS
code. We also note that payment will continue to be made for telehealth
services furnished by distant site PTs, OTs, or SLPs through the end of
CY 2024, and that these services will continue to be paid the non-
facility rate.
Comment: Some commenters expressed uncertainty about whether use of
POS 10 would be appropriate when furnishing telehealth services to
beneficiaries located in their homes for reasonable and necessary care
related to the treatment of an injury or illness for something not
related to the diagnosis, treatment, or management of an ongoing
behavioral health, mental health, or SUD issue.
Response: After consideration of public comments, we are finalizing
as proposed that beginning in CY 2024, claims for telehealth services
billed with POS 10 will be paid at the non-facility PFS rate. Claims
billed with POS 02 will continue to be paid at the facility rate. In
addition, we are clarifying that modifier '95' should be used when the
clinician is in the hospital and the patient is in the home, as well as
for outpatient therapy services furnished via telehealth by PT, OT, or
SLP.
f. Frequency Limitations on Medicare Telehealth Subsequent Care
Services in Inpatient and Nursing Facility Settings, and Critical Care
Consultations
When adding some services to the Medicare Telehealth Services List
in the past, we have included certain restrictions on how frequently a
service may be furnished via Medicare telehealth. These limitations
include a limit of once every 3 days for subsequent inpatient visits,
added in in the CY 2011 PFS final rule (75 FR 73317 through 73318), and
once every 14 days for subsequent nursing facility (NF) visits, added
in the CY 2016 final rule (80 FR 71062) furnished via Medicare
telehealth and a limit of once per day for critical care consultation
services; in establishing these limits, we cited concerns regarding the
potential acuity of these patients. End-stage renal disease (ESRD)-
related clinical assessments may be furnished via telehealth, subject
to the frequency limitations in section 1881(b)(3)(B) of the Act, which
provides that patients must receive a face-to-face visit, without the
use of telehealth, at least monthly in the case of the initial 3 months
of home dialysis and at least once every 3 consecutive months after the
initial 3 months.
In the March 31, 2020 COVID-19 IFC (85 FR 19241), we stated that as
it was our assessment that there was a patient population who would
otherwise not have had access to clinically appropriate in-person
treatment, and we did not believe these frequency limitations were
appropriate or necessary under the circumstances of the PHE. Therefore,
we removed the frequency restrictions for certain subsequent inpatient
visits, subsequent NF visits, and for critical care consultations
furnished via Medicare telehealth for the duration the PHE for COVID-
19. The frequency limitations resumed effect beginning on May 12, 2023,
(upon expiration of the PHE), in accordance with the March 31, 2020
[[Page 78877]]
IFC. However, we stated that, pursuant to waiver authority added under
section 1135(b)(8) of the Act by the Coronavirus Preparedness and
Response Supplemental Appropriations Act, 2020,\8\ we were exercising
enforcement discretion and will not consider these frequency
limitations through December 31, 2023; and that we anticipated
considering our policy further through our rulemaking process. As
discussed below, we proposed once again remove these telehealth
frequency limitations beginning CY 2024. We proposed to remove the
telehealth frequency limitations for the following codes:
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\8\ https://www.cms.gov/files/document/physicians-and-other-clinicians-cms-flexibilities-fight-covid-19.pdf.
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1. Subsequent Inpatient Visit CPT Codes
99231 (Subsequent hospital inpatient or observation care,
per day, for the evaluation and management of a patient, which requires
a medically appropriate history and/or examination and straightforward
or low level of medical decision making. when using total time on the
date of the encounter for code selection, 25 minutes must be met or
exceeded.);
99232 (Subsequent hospital inpatient or observation care,
per day, for the evaluation and management of a patient, which requires
a medically appropriate history and/or examination and moderate level
of medical decision making. when using total time on the date of the
encounter for code selection, 35 minutes must be met or exceeded.); and
99233 (Subsequent hospital inpatient or observation care,
per day, for the evaluation and management of a patient, which requires
a medically appropriate history and/or examination and high level of
medical decision making. when using total time on the date of the
encounter for code selection, 50 minutes must be met or exceeded.)
2. Subsequent Nursing Facility Visit CPT Codes
99307 (Subsequent nursing facility care, per day, for the
evaluation and management of a patient, which requires a medically
appropriate history and/or examination and straightforward medical
decision making. when using total time on the date of the encounter for
code selection, 10 minutes must be met or exceeded.);
99308 (Subsequent nursing facility care, per day, for the
evaluation and management of a patient, which requires a medically
appropriate history and/or examination and low level of medical
decision making. when using total time on the date of the encounter for
code selection, 15 minutes must be met or exceeded.);
99309 (Subsequent nursing facility care, per day, for the
evaluation and management of a patient, which requires a medically
appropriate history and/or examination and moderate level of medical
decision making. when using total time on the date of the encounter for
code selection, 30 minutes must be met or exceeded.); and
99310 (Subsequent nursing facility care, per day, for the
evaluation and management of a patient, which requires a medically
appropriate history and/or examination and high level of medical
decision making. when using total time on the date of the encounter for
code selection, 45 minutes must be met or exceeded.)
3. Critical Care Consultation Services: HCPCS Codes
G0508 (Telehealth consultation, critical care, initial,
physicians typically spend 60 minutes communicating with the patient
and providers via telehealth.); and
G0509 (Telehealth consultation, critical care, subsequent,
physicians typically spend 50 minutes communicating with the patient
and providers via telehealth.)
We proposed to remove the frequency limitations for these codes for
the duration of CY 2024, which aligns with other telehealth-related
flexibilities extended by the CAA, 2023. CMS is broadly assessing our
telehealth regulations, in light of the way practice patterns may have
changed in the roughly 3 years of the PHE for COVID-19 and, while we
engage in this assessment, we believe it is reasonable to pause certain
pre-pandemic restrictions, such as these frequency limitations, to
allow us to gather more information. We are seeking information from
interested parties on how practitioners have been ensuring that
Medicare beneficiaries receive subsequent inpatient and nursing
facility visits, as well as critical care consultation services since
the expiration of the PHE.
We received public comments on our proposals to remove frequency
limitations for Medicare Telehealth Subsequent Care Services in Nursing
Facility Settings, Subsequent Nursing Facility Visit, and Critical Care
Consultations. The following is a summary of the comments we received
and our responses.
Comment: Many commenters supported our proposal to remove frequency
limitations for 2024 for Medicare Telehealth Subsequent Care Services
in Nursing Facility Settings, Subsequent Nursing Facility Visit, and
Critical Care Consultations, stating that these frequency limitations
are arbitrary and would result in decreased access to care, potentially
leading to negative clinical outcomes. Some commenters urged us to
remove these limits permanently; according to one such commenter,
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. A commenter stated that the lifting these limitations during the
PHE has been instructive and demonstrates the value of continuing such
flexibilities. Another commenter stated that removing frequency
limitations helps practitioners keep patients in SNFs from being
unnecessarily evaluated in Emergency Departments and prevents
readmissions. In response to our concerns regarding patient safety and
program integrity, a commenter urged the agency to closely monitor
utilization patterns to determine whether the elimination of these
limitations leads to an increase in inappropriate utilization. A few
commenters did not support this proposal, stating that continuing to
waive these limitations without any guardrails will compromise patient
safety, as they do not believe that it is best practice for patients in
acute care settings (unless such settings are in rural or underserved
areas) to be treated daily via non-face-to-face telehealth visits/
consultations in lieu of in-person visits. Similarly, another commenter
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.
Response: We believe that continuing to suspend these frequency
limitations on a temporary basis for CY 2024 will allow us more time to
continue to evaluate patient safety while preserving access in a way
that is not disruptive to practice patterns that were established
during the PHE. We look forward to evaluating the information received
in response to this comment solicitation, as well as utilization data
and other data as we consider the most appropriate way to balance
patient safety concerns with the interest of supporting healthcare
access. We expect to address in future rulemaking.
Comment: A commenter stated that we should exercise enforcement
discretion for telehealth frequency limitations for home dialysis
clinical assessment while gathering information and evaluating changing
practice
[[Page 78878]]
patterns. The commenter noted that, without explanation, CMS is again
not extending the enforcement discretion to ESRD clinical assessments,
even though there has similarly been a change in practice patterns for
nephrologists during the PHE.
Response: We appreciate the commenters' concern; however, outside
of the circumstances of the PHE for COVID-19, we are continuing to
enforce the statutory requirement for in-person visits associated with
ESRD-related clinical assessments as established at section
1881(b)(3)(B) of the Act which requires that an individual determined
to have end stage renal disease receiving home dialysis receive a face-
to-face visit, without the use of telehealth, at least monthly in the
case of the initial 3 months of home dialysis and at least once every 3
consecutive months after the initial 3months
After consideration of public comments, we are finalizing as
proposed our proposal for CY 2024 to continue the removal of Medicare
telehealth services frequency limitations for Subsequent Inpatient
Visit, Subsequent Nursing Facility Visit, and Critical Care
Consultation Services.
2. Other Non-Face-to-Face Services Involving Communications Technology
Under the PFS
a. Direct Supervision via Use of Two-Way Audio/Video Communications
Technology
Under Medicare Part B, certain types of services, including
diagnostic tests, services incident to physicians' or practitioners'
professional services, and other services, are required to be furnished
under specific minimum levels of supervision by a physician or
practitioner. For most services furnished by auxiliary personnel
incident to the services of the billing physician or practitioner (see
Sec. 410.26) and many diagnostic tests (see Sec. 410.32), direct
supervision is required. Additionally, for pulmonary rehabilitation
services (see Sec. 410.47) and for cardiac rehabilitation and
intensive cardiac rehabilitation services (see Sec. 410.49), direct
supervision by a physician, PA, NP, or CNS is required (see also Sec.
410.27(a)(1)(iv)(B)(1) for hospital outpatient services). Outside the
circumstances of the PHE, direct supervision requires the immediate
availability of the supervising physician or other practitioner, but
the professional need not be present in the same room during the
service. We have established this ``immediate availability''
requirement to mean in-person, physical, not virtual, availability
(please see the April 6, 2020 IFC (85 FR 19245) and the CY 2022 PFS
final rule (86 FR 65062)). Through the March 31, 2020 COVID-19 IFC, we
changed the definition of ``direct supervision'' during the PHE for
COVID-19 (85 FR 19245 through 19246) as it pertains to supervision of
diagnostic tests, physicians' services, and some hospital outpatient
services, to allow the supervising professional to be immediately
available through virtual presence using two-way, real-time audio/video
technology, instead of requiring their physical presence. In the CY
2021 PFS final rule (85 FR 84538 through 84540), we finalized
continuation of this policy through the later of the end of the
calendar year in which the PHE for COVID-19 ends or December 31, 2021.
In the March 31, 2020 IFC (85 FR 19246) and in our CY 2022 PFS final
rule (see 85 FR 65063), we also noted that the temporary exception to
allow immediate availability for direct supervision through virtual
presence facilitates the provision of Medicare telehealth services by
clinical staff of physicians and other practitioners' incident to their
own professional services. This is especially relevant for services
such as physical therapy, occupational therapy, and speech language
pathology services, since those practitioners were previously only able
to bill Medicare for telehealth services under Medicare telehealth
waivers that were effective during the PHE for COVID-19 (based on the
emergency waiver authority established in section 1135(b)(8) of the
Act), until the CAA, 2023 extended the time period during which these
practitioners could bill for Medicare telehealth services through
December 31, 2024. We noted that sections 1834(m)(4)(D) and (E) of the
Act specify the types of clinicians who may furnish and bill for
Medicare telehealth services. After December 31, 2024, the types of
clinicians who may furnish and bill for Medicare telehealth services
include only physicians as defined in section 1861(r) of the Act and
practitioners described in section 1842(b)(18)(C) of the Act. We note
that this will include mental health counselors (MHCs) and marriage and
family therapists (MFTs) beginning January 1, 2024.
We noted in the CY 2021 PFS final rule (85 FR 84539) that, to the
extent our policy allows direct supervision through virtual presence
using audio/video real-time communications technology, the requirement
could be met by the supervising physician (or other practitioner) being
immediately available to engage via audio/video technology (excluding
audio-only), and would not require real-time presence or observation of
the service via interactive audio and video technology throughout the
performance of the procedure; this was the case during the PHE, and
will continue to be the case following the PHE. Under current policy as
described in the CY 2021 final rule (85 FR 84539 and 84540, after
December 31, 2023, the pre-PHE rules for direct supervision at Sec.
410.32(b)(3)(ii) would apply. As noted in the CY 2022 PFS final rule
(86 FR 65062), this means the temporary exception allowing immediate
availability for direct supervision through virtual presence, which
facilitates the provision of telehealth services by clinical staff of
physicians and other practitioners incident to their professional
services, will no longer apply after CY 2023.
We are concerned about an abrupt transition to our pre-PHE policy
that defines direct supervision under Sec. 410.32(b)(3)(ii) to require
the physical presence of the supervising practitioner beginning after
December 31, 2023, given that practitioners have established new
patterns of practice during the PHE for COVID-19. In the absence of
evidence that patient safety is compromised by virtual direct
supervision, we believe that an immediate reversion to the pre-PHE
definition of direct supervision would prohibit virtual direct
supervision, which may present a barrier to access to many services,
such as those furnished incident--to a physician's service. We believe
physicians and practitioners will need time to reorganize their
practice patterns established during the PHE to reimplement the pre-PHE
approach to direct supervision without the use of audio/video
technology. Recognizing these concerns, we 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, 2024. We
believe that extending this definition of direct supervision through
December 31, 2024 would align the timeframe of this policy with many of
the previously discussed PHE-related telehealth policies that were
extended under provisions of the CAA, 2023. We proposed to revise the
regulatory text at Sec. 410.32(b)(3)(ii) to state that, through
December 31, 2024, the presence of the physician (or other
practitioner) includes virtual presence through audio/video real-time
communications technology (excluding audio-only).
[[Page 78879]]
We believe this additional time will allow us further opportunity
to collect information through the coming year as we consider an
appropriate more permanent approach to direct supervision policy
following the PHE for COVID-19. We solicited comment 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 virtual direct supervision of
certain types of services is more or less likely to present patient
safety concerns, or if this flexibility would be more appropriate for
certain types of services, or when certain types of auxiliary personnel
are performing the supervised service. We were also interested in
potential program integrity concerns such as overutilization or fraud
and abuse that interested parties may have regarding this policy.
In the proposed rule, we noted that one potential approach to
direct supervision which we could consider for future rulemaking, could
be to extend or permanently establish this virtual presence flexibility
for services that are valued under the PFS based on the presumption
that they are nearly always performed in entirety by auxiliary
personnel. Such services would include any service wholly furnished
incident to a physician or practitioner's professional service, as well
as the Level I office or other outpatient evaluation and management
visit for established patients and the Level I Emergency Department
visit. Allowing virtual presence for direct supervision of these
services may balance patient safety concerns with the interest of
supporting access and preserving workforce capacity for medical
professionals while considering potential quality and program integrity
concerns. We solicited comment on this potential approach for CY 2025,
as well as any other approaches by which direct supervision could occur
virtually that would both protect patient access and safety, as well as
quality of care and program integrity concerns following CY 2024.
We received public comments on our proposals to extend the
flexibilities for virtual direct supervision. The following is a
summary of the comments we received and our responses.
Comment: Many commenters supported our proposal to continue to
define `immediate availability' to include availability through virtual
means, stating that it will benefit healthcare providers while greatly
enhancing patient access to quality care, particularly in underserved
areas. Many stated that removing overly restrictive supervision
requirements will help practices free up personnel to ensure more
Americans have timely access to care. A commenter stated that there has
been no evidence that this type of direct supervision has caused
patient safety or quality concerns, and that virtual supervision makes
workflows more efficient by freeing up practitioners' time. A commenter
submitted data that they say indicates no clinically meaningful
statistical difference in patient outcomes for virtual direct
supervision as compared to direct supervision. Some commenters stated
that we should extend this flexibility permanently; one such commenter
stated that failure to allow supervision via interactive
telecommunications could mean that a patient would be unable to receive
the service at all, rather than forcing in-person supervision to occur.
The commenter stated that both patients and CMS rely on physicians'
professional judgment to determine the most appropriate services to
deliver; the same principle should apply to how supervision is
provided. Another commenter encouraged CMS to consider permanently
permitting the use of remote direct supervision for Level 2 diagnostic
tests, and that, absent a permanent change, CMS should consider
extending current flexibilities through at least 2025. Some commenters
stated that the ``immediate availability'' requirement should be
defined as including virtual means permanently for Intensive Cardiac
Rehabilitation (ICR) and cardiac rehab (CR) services, as well as for
pulmonary rehabilitation (PR) stating that evidence from the PHE
demonstrated that virtual supervision is safe and effective for the
delivery of these services. Many commenters noted the importance of
this flexibility in protecting access specifically for ICR, CR, and PR
services. One such commenter submitted studies that the commenter says
demonstrates the effectiveness and safety of virtual CR and PR services
as well as that virtual and hybrid delivery of CR and PR services
provided by staff are safe, improve health outcomes and adherence, and
address barriers to access. Some commenters stated that this should be
permanently established for external counterpulsation (ECP) therapy
(HCPCS code G0166). One such commenter stated that as this is a service
that is entirely provided by auxiliary personnel that it would be
consistent with our suggested approach included in our comment
solicitation as discussed above. A commenter submitted information on
the clinical benefits of ECP and argued that ECP is underutilized and
that the in-person direct supervision requirement presents an access
barrier. Some commenters specified that this should be established
permanently for mental health and substance use disorder related
services. In response to our patient safety concerns, a commenter
stated that if CMS were to extend this policy permanently, it should be
limited to circumstances where the billing practitioner is supervising
clinical staff who are not authorized to bill the Medicare program
directly, consistent with MedPAC's recommendations in their June 2019
report. A few commenters reacted to the potential approach we suggested
of permanently establishing this virtual presence flexibility for
services that are valued under the PFS based on the presumption that
they are nearly always performed in entirety by auxiliary personnel.
One such comment stated that this approach may prove a conservative
place to start or could be attempted through pilot tests to collect
more data to inform future decision-making. Another stated that this
approach would be overly restrictive and would be contrary to the
principles of a successful telehealth model, such as increasing
workforce capacity and reducing patient travel.
Response: We appreciate the support of commenters, as well as the
comments received in response to our comment solicitation. We look
forward to considering this and other information as we consider the
most appropriate way to balance patient safety concerns with the
interest of supporting access that we expect to address in future
rulemaking. We continue to believe that it is appropriate to continue
to permit direct supervision via virtual means using audio/video real-
time communications technology through the end of CY 2024 given that
many telehealth flexibilities adopted to address the PHE for COVID-19
are set to expire under the statute following this time period. We
believe that this is the most appropriate way to balance patient safety
with access while avoiding confusion for 2024.
Comment: A commenter requested that CMS clarify whether, to meet
the direct supervision requirement using real-time audio-visual
technology, the physician needs to be constantly present on the real-
time audio-visual technology during the entirety of the provision of
[[Page 78880]]
an ``incident to'' service by their clinical staff.
Response: As direct supervision as defined at Sec. 410.32 requires
the supervising practitioner's immediately available to furnish
assistance and direction throughout the performance of the procedure,
but not that the supervising practitioner must be present in the room
when the procedure is performed, when the supervising practitioner
provides direct supervision using real-time audio-visual technology,
the supervising practitioner likewise does not need to be virtually
present throughout the performance of the procedure, but they need to
be immediately available to provide the virtual presence whenever
necessary.
After consideration of public comments, we are finalizing as
proposed. We will continue to define direct supervision to permit the
immediate availability of the supervising practitioner through real-
time audio and visual interactive telecommunications through December
31, 2024.We will consider addressing this topic in possible future
rulemaking.
(1) Teaching Physician Billing for Services Involving Residents in
Teaching Settings
In the CY 2021 PFS final rule (85 FR 84577 through 84584), we
established a policy that, after the end of the PHE for COVID-19,
teaching physicians may meet the requirements to be present for the key
or critical portions of services when furnished involving residents
through audio/video real-time communications technology (virtual
presence), but only for services furnished in residency training sites
that are located outside of an Office of Management and Budget (OMB)-
defined metropolitan statistical area (MSA). We made this location
distinction consistent with our longstanding interest to increase
beneficiary access to Medicare-covered services in rural areas and
noted the ability to expand training opportunities for residents in
rural settings. For all other locations, we expressed concerns that
continuing to permit teaching physicians to bill for services furnished
involving residents when they are virtually present, outside the
conditions of the PHE for COVID-19, may not allow the teaching
physician to have personal oversight and involvement over the
management of the portion of the case for which the payment is sought,
in accordance with section 1842(b)(7)(A)(i)(I) of the Act. In addition,
we stated concerns about patient populations that may require a
teaching physician's experience and skill to recognize specialized
needs or testing, and whether it is possible for the teaching physician
to meet these clinical needs while having a virtual presence for the
key portion of the service. For a more detailed description of our
specific concerns, we referred readers to the CY 2021 PFS final rule
(85 FR 84577 through 84584). At the end of the PHE for COVID-19, and as
finalized in the CY 2021 PFS final rule, we intended for the teaching
physician to have a physical presence during the key portion of the
service personally provided by residents in order to be paid for the
service under the PFS, in locations that were within a MSA. This policy
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 have a physical presence with the resident when
a service is furnished virtually within a MSA (that is, as a Medicare
telehealth service). Some interested parties 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. As stated in section II.D.2.a. of this
final rule, we were concerned that an abrupt transition to our pre-PHE
policy may present a barrier to access to many services, and we
understood that practitioners gained clinical experience during the PHE
for COVID-19, and could identify circumstances for which the teaching
physician can routinely render sufficient personal and identifiable
services to the patient, with a virtual presence during the key portion
of the virtual service. Given these considerations, we proposed to
allow the teaching physician to have a virtual presence in all teaching
settings, only in clinical instances when the service is furnished
virtually (for example, a 3-way telehealth visit, with all parties in
separate locations). This would permit teaching physicians to have a
virtual presence during the key portion of the virtual service for
which payment is sought, through audio/video real-time communications
technology, for all residency training locations through December 31,
2024. The virtual presence policy would continue to require real-time
observation (not mere availability) by the teaching physician, and
excludes audio-only technology. The documentation in the medical record
must continue to demonstrate whether the teaching physician was
physically present or present through audio/video real-time
communications technology at the time of the virtual service, this
includes documenting the specific portion of the service for which the
teaching physician was present through audio/video real-time
communications technology. This policy does not preclude teaching
physicians from providing a greater degree of involvement in services
furnished with residents, and teaching physicians should still use
discretion to determine whether it is appropriate to have a virtual
presence rather than in person, depending on the services being
furnished and the experience of the particular residents involved.
We announced that we were exercising enforcement discretion to
allow teaching physicians in all residency training sites, to be
present through audio/video real-time communications technology, for
purposes of billing under the PFS for services they furnish involving
residents. We exercised this enforcement discretion through December
31, 2023, as we considered our virtual presence policies for services
involving teaching physicians and residents further through our
rulemaking process for CY 2024. For more background we referred readers
to https://www.cms.gov/files/document/frequently-asked-questions-cms-waivers-flexibilities-and-end-covid-19-public-health-emergency.pdf.
We sought comment and information to help us consider how virtual
services could be furnished in all residency training locations beyond
December 31, 2024, to include what other clinical treatment situations
are appropriate to permit the virtual presence of the teaching
physician. Specifically, we anticipated considering various types of
teaching physician services, when it is appropriate for the teaching
physician and resident to be co-located, and how virtual presence could
support patient safety for all patients, particularly at-risk patients.
We also invited commenters to provide data or other information on how
the teaching physician's virtual presence could continue to support
patient safety, while meeting the clinical needs for all patients, and
ensure burden reduction
[[Page 78881]]
without creating risks to patient care or increasing opportunities for
fraud.
We received public comments on our proposal to allow teaching
physicians to have a virtual presence in all teaching settings, only in
clinical instances when the service is furnished virtually, through
December 31, 2024. The following is a summary of the comments we
received and our responses.
Comment: Some commenters thanked CMS for exercising enforcement
discretion to allow teaching physicians in all residency training sites
to be present through audio/video real-time communications technology,
for purposes of billing under the PFS, for services they furnish
involving residents through 2024.
Response: We appreciate the support from commenters but reiterate
that we are only exercising enforcement discretion through December 31,
2023.
Comment: One commenter stated that CMS should not reimburse
anesthesiologists that are not providing actual anesthesia care,
through billing for remote so-called ``supervision'' services.
Response: As stated in our regulation at Sec. 415.172(a)(1), for
surgical, high risk, interventional, endoscopic, or other complex
procedures the teaching physician must not only be present for the
critical portions of the procedure, but also immediately available to
furnish services during the entire procedure in order for PFS payment
to be made for the service. Similarly, Sec. 415.178 requires a
teaching physician to be present during critical (or key) portions of
the procedure and immediately available to furnish anesthesia services
during the entire service. We continue to believe the requirements for
the presence of the teaching physician during all key or critical
portions of the procedure and immediate availability to furnish
services during the entire service or procedure is necessary for
patient safety given the risks associated with these services.
Comment: One commenter requested clarification on whether the
proposal to allow teaching physicians to have a virtual presence, only
in clinical instances when the service is furnished virtually, would
also include instances where the resident and patient are in one
location and the supervising physician is in another. The commenter
stated that the resident should be able to ``dial-in'' the supervising
physician in these instances.
Response: The proposed policy would continue to permit PFS payment
when the teaching physician is present virtually only when the service
is furnished virtually. The example we provided in the proposed rule is
a 3-way Medicare telehealth visit, with all parties in separate
locations. In this situation, the teaching physician and resident would
not need to be physically co-located during the telehealth service that
is furnished remotely to the patient. The teaching physician would have
a virtual presence during the key portion of that Medicare telehealth
service for which payment is sought, through audio/video real-time
communications technology. In the example provided by the commenter,
the service would be furnished with the resident in person at the same
location with the patient, and only the teaching physician would be
present virtually through the use of real-time audio/video
communications technology, and this scenario was not included in the
proposal. In the commenter's example, the teaching physician would be
required to have a physical presence with the resident, unless the
residency training location is outside a MSA. The policy continues to
exclude audio-only technology.
Comment: Several commenters requested that CMS consider permanently
expanding the list of services that can be furnished under the so-
called primary care exception set forth at Sec. 415.174 to include
high-value primary care services. These commenters stated that the
flexibilities allowed during the PHE for COVID-19, which allowed level
4 and 5 E/M visits to be furnished under the primary care exception
benefitted both patients and primary care training programs. The
commenters noted that they believe that the absence of high-value
services under the primary care exception could negatively impact
resident training and patient outcomes in the long term, and provided a
list of suggested services to be permanently included under the primary
care exception.
Response: The primary care exception permits the teaching physician
to bill for certain lower and mid-level complexity physicians' services
furnished by residents in certain types of residency training settings
even when the teaching physician is not present with the resident
during the services as long as certain conditions are met, including
that the services are furnished by residents with more than 6 months of
training in the approved residency program; and that the teaching
physician directs the care of no more than four residents at a time,
remains immediately available and has no other responsibilities while
directing the care, assumes management responsibility for beneficiaries
seen by the residents, ensures that the services furnished are
appropriate, and reviews certain elements of the services with each
resident during or immediately after each visit. We believe the primary
care exception was intended to broaden opportunities for teaching
physicians to involve residents in furnishing services under
circumstances that preserve teaching physician direction of the care,
and promote safe, high quality patient care. Although we temporarily
modified the scope of services that could be provided under the primary
care exception to address the circumstances of the PHE for COVID-19, we
did not propose to broaden the array of services that meet the
conditions for PFS payment set forth in our regulations at Sec.
415.174. For a more detailed description of the finalized primary care
exception policy, we refer readers to the CY 2021 PFS final rule (85 FR
84585 through 84590).
Comment: Many commenters supported the proposal to allow teaching
physicians to have a virtual presence in all teaching settings, only in
clinical instances when the service is furnished virtually, which then
permits teaching physicians to have a virtual presence during the key
portion of that Medicare telehealth service, through audio/video real-
time communications technology, for all residency training locations
through December 31, 2024. However, several commenters encouraged CMS
to include in-person services to promote access to care and to
establish this policy permanently. These commenters 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. In
addition, commenters recommend that CMS consider the Accreditation
Council for Graduate Medical Education (ACGME) rules that 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.
Response: At this time, we are not extending the proposed policy to
include in-person services furnished by residents. We may consider
other clinical instances that could allow teaching physicians to have a
virtual presence in future rulemaking, and will contemplate the
comments received to ensure the teaching physician is rendering
sufficient personal services to exercise full, personal control of the
key portion of the case. We thank commenters for providing information
[[Page 78882]]
on certain ACGME rules. We note that the ACGME regulates residency
training programs and their rules ensure that there is appropriate
teaching physician involvement in care delivery for educational
purposes. However, our regulations determine when PFS payment is
appropriate when teaching physicians furnish services that involve
residents, and the teaching physician has personal oversight and
involvement over the management of the portion of the case for which
the payment is sought.
After consideration of public comments, we are finalizing the
policy as proposed, to allow teaching physicians to have a virtual
presence in all teaching settings, only in clinical instances when the
service is furnished virtually. This permits teaching physicians to
have a virtual presence during the key portion of the virtual service
for which payment is sought, through audio/video real-time
communications technology, for all residency training locations through
December 31, 2024. As finalized in the CY 2021 PFS final rule (84577
through 84581), the required physical presence of a teaching physician
in order to bill under the PFS for their services at a residency
training site that is located outside of a MSA, can be met through
interactive, audio/video real-time communications technology, and does
not include audio-only technology.
b. Clarifications for Remote Monitoring Services
(1) Background and Overview
In recent years, we have established payment for two code families
that describe certain remote monitoring services: remote physiologic
monitoring (RPM) and remote therapy monitoring (RTM).
Remote Physiologic Monitoring
99453 (Remote monitoring of physiologic parameter(s) (eg,
weight, blood pressure, pulse oximetry, respiratory flow rate),
initial; set-up and patient education on use of equipment);
99454 (Remote monitoring of physiologic parameter(s) (eg,
weight, blood pressure, pulse oximetry, respiratory flow rate),
initial; device(s) supply with daily recording(s) or programmed
alert(s) transmission, each 30 days);
99457 (Remote physiologic monitoring treatment management
services, clinical staff/physician/other qualified health care
professional time in a calendar month requiring interactive
communication with the patient/caregiver during the month; first 20
minutes); and
99458 (Remote physiologic monitoring treatment management
services, clinical staff/physician/other qualified health care
professional time in a calendar month requiring interactive
communication with the patient/caregiver during the month; each
additional 20 minutes (List separately in addition to code for primary
procedure)).
Remote Therapeutic Monitoring
98975 (Remote therapeutic monitoring (eg, therapy
adherence, therapy response); initial set-up and patient education on
use of equipment);
98976 (Remote therapeutic monitoring (eg, therapy
adherence, therapy response); device(s) supply with scheduled (eg,
daily) recording(s) and/or programmed alert(s) transmission to monitor
respiratory system, each 30 days);
98977 (Remote therapeutic monitoring (eg, therapy
adherence, therapy response); device(s) supply with scheduled (eg,
daily) recording(s) and/or programmed alert(s) transmission to monitor
musculoskeletal system, each 30 days);
98978 (Remote therapeutic monitoring (eg, therapy
adherence, therapy response); device(s) supply with scheduled (eg,
daily) recording(s) and/or programmed alert(s) transmission to monitor
cognitive behavioral therapy, each 30 days);
98980 (Remote therapeutic monitoring treatment management
services, physician or other qualified health care professional time in
a calendar month requiring at least one interactive communication with
the patient or caregiver during the calendar month; first 20 minutes);
and
98981 (Remote therapeutic monitoring treatment management
services, physician or other qualified health care professional time in
a calendar month requiring at least one interactive communication with
the patient or caregiver during the calendar month; each additional 20
minutes (List separately in addition to code for primary procedure))
In our CY 2018 PFS final rule, we summarized feedback from a
comment solicitation aimed at informing new payment policies that would
allow for separate payment for remote monitoring services (82 FR
53014). In our CY 2019 PFS final rule (83 FR 59574 to 59576), we
established valuations and payment policy for the RPM code family. In
our CY 2020 PFS final rule (84 FR 62697-8), we explained that the RPM
code family describes chronic care RPM services that involve the
collection, analysis, and interpretation of digitally collected
physiologic data, followed by the development of a treatment plan and
the managing of a patient under the treatment plan. (84 FR 62697). In
our CY 2020 PFS final rule, we also discussed that remote monitoring
codes would be designated as care management services, which means our
rules for general supervision would apply (84 FR 62698). In our CY 2023
PFS final rule, in response to comments, we clarified that RTM or RPM
services could be billed concurrently with Chronic Care Management
(CCM), Transitional Care Management TCM, Principal Care Management
(PCM), Chronic Pain Management (CPM), or Behavioral Health Integration
(BHI) (86 FR 69528-69539).
We have received many questions from interested parties about
billing scenarios and requests for clarifications on the appropriate
use of these codes in general. We believe it is important to share with
all interested parties a restatement/clarification of certain policies.
We refer readers to the CY 2021 PFS final rule (85 FR 84542 to 84546)
for further discussion and explanation of the basis for interim
policies that expired on the last day of the PHE for COVID-19.
(2) New vs. Established Patient Requirements
In the CY 2021 PFS final rule (85 FR 84542-6), we established that,
when the PHE for COVID-19 ends, we again will require that RPM services
be furnished only to an established patient. Patients who received
initial remote monitoring services during PHE are considered
established patients for purposes of the new patient requirements that
are effective after the last day of the PHE for COVID-19.
(3) Data Collection Requirements
We have received various comments and inquiries about our temporary
exception to minimum data collection for remote monitoring. As
discussed in our CY 2021 final rule, we are not extending beyond the
end of the PHE the interim policy to permit billing for remote
monitoring codes, which require data collection for at least 16 days in
a 30-day period, when less than 16 of days data are collected within a
given 30-day period. (85 FR 84542 through 84546). As of the end of the
PHE, the 16-day monitoring requirement was reinstated. Monitoring must
occur over at least 16 days of a 30-day period. We proposed to clarify
that the data collection minimums apply to existing RPM and RTM code
families for CY 2024.
[[Page 78883]]
The following remote monitoring codes currently depend on
collection of no fewer than 16 days of data in a 30-day period, as
defined and specified in the code descriptions:
98976 (Remote therapeutic monitoring (eg, therapy
adherence, therapy response); device(s) supply with scheduled (eg,
daily) recording(s) and/or programmed alert(s) transmission to monitor
respiratory system, each 30 days);
98977 (Remote therapeutic monitoring (eg, therapy
adherence, therapy response); device(s) supply with scheduled (eg,
daily) recording(s) and/or programmed alert(s) transmission to monitor
musculoskeletal system, each 30 days);
98978 (Remote therapeutic monitoring (eg, therapy
adherence, therapy response); device(s) supply with scheduled (eg,
daily) recording(s) and/or programmed alert(s) transmission to monitor
cognitive behavioral therapy, each 30 days);
98980 (Remote therapeutic monitoring treatment management
services, physician or other qualified health care professional time in
a calendar month requiring at least one interactive communication with
the patient or caregiver during the calendar month; first 20 minutes);
and
98981 (Remote therapeutic monitoring treatment management
services, physician or other qualified health care professional time in
a calendar month requiring at least one interactive communication with
the patient or caregiver during the calendar month; each additional 20
minutes (List separately in addition to code for primary procedure))
We remind readers that our discussion in the CY 2021 PFS final rule
addresses the interim policy on data collection minimums, and provides
notice and the rationale for the data collection policy that is in
effect now that the PHE for COVID-19 has ended. Remotely monitored
monthly services should be reported only once during a 30-day period--
and only when reasonable and necessary. As a clarification for either
RPM or RTM, only one practitioner can bill CPT codes 99453 and 99454,
or CPT codes 98976, 98977, 98980, and 98981, during a 30-day period,
and only when at least 16 days of data have been collected on at least
one medical device as defined in section 201(h) of the FFDCA.
We reiterate our analysis described in the CY 2021 PFS final rule,
in which we explained that CPT code descriptor language suggests that,
even when multiple medical devices are provided to a patient, the
services associated with all the medical devices can be billed only
once per patient per 30-day period and only when at least 16 days of
data have been collected (85 FR 84545). We refer readers to our CY 2021
PFS final rule (85 FR 84545) for additional background.
(4) Use of RPM, RTM, in Conjunction With Other Services
Practitioners may bill RPM or RTM, but not both RPM and RTM,
concurrently with the following care management services: CCM/TCM/BHI,
PCM, and CPM. These various codes, which describe other care management
services, may be billed with RPM or RTM, for the same patient, if the
time or effort is not counted twice. As specified in the CY 2023 PFS
final rule, if all requirements to report each service are met, without
time or effort being counted more than once, RPM or RTM (not both RPM
and RTM) may be billed in conjunction with any one of CCM, TCM, BHI,
PCM, or CPM codes. According to the 2023 CPT Codebook (pg. 849), CPT
code 98980 (RTM treatment management) cannot be reported in conjunction
with CPT codes 99457/99458 (RPM treatment management). Our intention is
to allow the maximum flexibility for a given practitioner to select the
appropriate mix of care management services, without creating
significant issues of possible fraud, waste, and abuse associated with
overbilling of these services. We continue to gain experience with each
family of remote monitoring codes, and request feedback from commenters
that would provide additional context that could inform us as we
continue to develop and clarify our payment policies for these
services.
We proposed to clarify that RPM and RTM may not be billed together,
so that no time is counted twice by billing for concurrent RPM and RTM
services. In instances where the same patient receives RPM and RTM
services, there may be multiple devices used for monitoring, and in
these cases, we will to apply our existing rules, which we finalized
when establishing the RPM code family, meaning that the services
associated with all the medical devices can be billed by only one
practitioner, only once per patient, per 30-day period, and only when
at least 16 days of data have been collected; and that the services
must be reasonable and necessary (85 FR 84544 through 84545).
(5) Other Clarifications for Appropriate Billing
We have received inquiries from interested parties during public
forums regarding use of remote monitoring during global periods for
surgery. In the proposed rule, we clarified that, in circumstances
where an individual beneficiary may receive a procedure or surgery, and
related services, which are covered under a payment for a global
period, RPM services or RTM services (but not both RPM and RTM services
concurrently) may be furnished separately to the beneficiary, and the
practitioner would receive payment for the RTM or RPM services,
separate from the global service payment, so long as other requirements
for the global service and any other service during the global period
are met. For an individual beneficiary who is currently receiving
services during a global period, a practitioner may furnish RPM or RTM
services (but not both RPM or RTM services) to the individual
beneficiary, and the practitioner will receive separate payment, so
long as the remote monitoring services are unrelated to the diagnosis
for which the global procedure is performed, and as long as the purpose
of the remote monitoring addresses an episode of care that is separate
and distinct from the episode of care for the global procedure--meaning
that the remote monitoring services address an underlying condition
that is not linked to the global procedure or service.
We solicited comments on the proposed clarifications, as well as
issued a request for general feedback from the public that may be
useful in further development of our payment policies for remote
monitoring services that are separately payable under the current PFS.
The following is a summary of the comments we received and our
responses.
Comment: Commenters requested changes be made to RPM and RTM coding
and service requirements and requested that interim policies that
expired on the last day of the PHE for COVID-19 become permanent.
Response: We thank commenters for the general feedback that may be
useful in further development of our payment policies for remote
monitoring services that are separately payable under the current PFS.
We refer readers to the CY 2021 PFS final rule (85 FR 84542 through
84546) for further discussion and explanation of the basis for interim
policies that expired on the last day of the PHE for COVID-19.
Comment: Several commenters requested clarification on patient
requirements for remote therapeutic monitoring. One commenter requested
clarification on new patients receiving RPM from the end of the PHE
forward.
Response: We are offering additional clarification regarding the
new patient
[[Page 78884]]
requirement and that RPM, not RTM, services require an established
patient relationship after the end of the PHE. While we have not
specified in rulemaking whether the RTM services require an established
patient relationship, we believe that similar to RPM, such services
would be furnished to a patient after a treatment plan had been
established. Presumably, a billing practitioner would establish such
treatment plan after some initial interaction with the patient. We will
work to clarify this policy further in future rulemaking. We hope to
continue dialogue with interested parties who may have information that
could inform our rulemaking. Patients who received initial remote
monitoring services during the PHE are considered established patients
for purposes of the new patient requirements that are effective after
the last day of the PHE for COVID-19. Per our existing policy, any
patients receiving RPM services from the end of the PHE forward will
need to be established patients before beginning RPM services.
Comment: Many commenters inquired about whether RPM or RTM used in
physical and occupational therapy services were excluded from the
global period rules for surgery.
Response: We would like to clarify that the policy that prohibits
RPM or RTM services being furnished during the global period only
applies to billing practitioners who are receiving the global service
payment. Practitioners, such as therapists, who are not receiving a
global service payment because they did not furnish the global
procedure, would be permitted to furnish RPM or RTM services during a
global period. After consideration of public comments, we are
finalizing that providing RTM or RPM services during the global period
is permitted if the practitioner is not receiving global service
payment because they did not furnish the global procedure.
We note that in the CY 2024 PFS proposed rule, we inadvertently
listed all of the RTM codes (88 FR 53204) in our discussion of these
services and had made a general statement about the applicability of
the 16-day data collection requirement. We would like to offer
clarification that the 16 day data collection requirement does not
apply to CPT codes 99457, 99458, 98980, and 98981. These CPT codes are
treatment management codes that account for time spent in a calendar
month and do not require 16 days of data collection in a 30-day period.
c. Telephone Evaluation and Management Services
In the March 31st COVID-19 IFC (85 FR 19264 through 19265), we
finalized separate payment for CPT codes 99441 through 99443 and 98966
through 98968, which describe E/M and assessment and management
services furnished via telephone. CPT codes 99441 through 99443 are on
the Medicare Telehealth Services List and will remain actively priced
through 2024. CPT codes 98966 through 98968; however, describe
telephone assessment and management services provided by a qualified
non-physician healthcare professional, and they were added on a
subregulatory basis during the PHE. We proposed to continue to assign
an active payment status to CPT codes 98966 through 98968 for CY 2024
to align with telehealth-related flexibilities that were extended via
the CAA, 2023, specifically section 4113(e) of the CAA, 2023, which
permits the provision of telehealth services through audio-only
telecommunications through the end of 2024.
We received comments on our proposals to keep active payment status
for CPT codes 98966 through 98968 for CY 2024 to align with policy
extensions under the CAA, 2023. The following is a summary of the
comments received and our responses.
Comment: Commenters were supportive of our proposal to continue to
pay for physician and non-physician telephone services through December
31, 2024, and to continue to assign active payment status to CPT codes
99441 through 99443 as well as to CPT codes 98966 through 98968, which
they stated supports payment for audio-only visits. The commenters
stated that these services are a critical component of how care is
provided to patients and are particularly valuable in connecting with
patients living in rural areas where regular internet connection and/or
cellular reception may be entirely unavailable or unreliable.
Response: In response to comments, we are finalizing our proposal
to continue active payment status for CPT codes 98966 through 98968.
These services will be available through the end of CY 2024.
3. Telehealth Originating Site Facility Fee Payment Amount Update
Section 1834(m)(2)(B) of the Act established the Medicare
telehealth originating site facility fee for telehealth services
furnished from October 1, 2001 through December 31, 2002 at $20.00, and
specifies that, for telehealth services furnished on or after January 1
of each subsequent calendar year, the telehealth originating site
facility fee is increased by the percentage increase in the Medicare
Economic Index (MEI) as defined in section 1842(i)(3) of the Act. We
proposed to update the telehealth originating site facility fee for
telehealth services by the expected increase in the MEI of 4.5 percent
for CY 2024. Furthermore, we proposed that if more recent data became
available after the publication of the proposed rule and before the
publication of the final rule (for example, a more recent estimate of
the MEI percentage increase), we would use such data, if appropriate,
to determine the CY 2024 MEI percentage increase in the final rule.
Therefore, the final MEI increase for CY 2024 is 4.6 percent and is
based on the most recent historical percentage increase of the 2017-
based MEI reflecting historical data through for the second quarter of
2023.
Therefore, for CY 2024, the final payment amount for HCPCS code
Q3014 (Telehealth originating site facility fee) is $29.96. Table 12
shows the Medicare telehealth originating site facility fee and the
corresponding MEI percentage increase for each applicable time period.
We did not receive any comments on this proposal and are finalizing as
proposed.
[[Page 78885]]
[GRAPHIC] [TIFF OMITTED] TR16NO23.020
4. Payment for Outpatient Therapy Services, Diabetes Self-Management
Training, and Medical Nutrition Therapy When Furnished by Institutional
Staff to Beneficiaries in Their Homes Through Communication Technology
a. Background on Outpatient Therapy Services, Diabetes Self-Management
Training and Medical Nutrition Therapy
Section 1861(p) of the Act establishes the benefit category for
outpatient PT, SLP and OT services, (expressly for PT services and,
through section 1861(ll)(2) of the Act, for outpatient SLP services
and, through section 1861(g) of the Act, for outpatient OT services).
Section 1861(p) of the Act defines outpatient therapy services in the
three disciplines as those furnished by a provider of services, a
clinic, rehabilitation agency, or a public health agency, or by others
under an arrangement with, and under the supervision of, such provider,
clinic, rehabilitation agency, or public health agency to an individual
as an outpatient; and those furnished by a therapist not under
arrangements with a provider of services, clinic, rehabilitation
agency, or a public health agency. As such, section 1861(p) of the Act
defines outpatient therapy services very broadly to include those
furnished by providers and other institutional settings, as well as
those furnished in office settings. Section 1834(k)(3) of the Act
requires payment for outpatient therapy services to be made based on
the PFS (via section 1848 of the Act), for all institutional providers
listed at sections 1833(a)(8) and (9) of the Act. These providers
include clinics, rehabilitation agencies, public health agencies,
comprehensive outpatient rehabilitation agencies (CORFs), SNFs, home
health agencies (HHAs) (to individuals who are not homebound),
hospitals to outpatients or hospital inpatients who are entitled to
benefits under part A but have exhausted benefits for inpatient
hospital services during a spell of illness or is not so entitled to
benefits under part A), and all other CORF services.
Section 1861(qq) of the Act defines Diabetes Self-Management
Training (DSMT) services and authorizes CMS to regulate Medicare DSMT
outpatient services. A ``certified provider'' of DSMT is further
defined in section 1861(qq)(2)(A) of the Act as a physician or other
individual or entity designated by the Secretary who meets certain
quality requirements described in section 1861(qq)(2)(B) of the Act. In
CY 2000, we finalized a standalone rule titled ``Medicare Program;
Expanded Coverage for Outpatient Diabetes Self-Management Training and
Diabetes Outcome Measurements.'' In that rule, we finalized that
payment for outpatient DSMT would be made under the PFS (65 FR 83132).
We further established that, in the case of payments made to other
approved entities, such as hospital outpatient departments, ESRD
facilities, and durable medical equipment suppliers, the payment would
be equal to the amounts established under the PFS and made under the
appropriate payment systems (65 FR 83142).
Section 1861(s)(2)(V) of the Act authorizes Medicare Part B
coverage of medical nutrition therapy services (MNT) for certain
beneficiaries who have diabetes or a renal disease. In the CY 2000 PFS
final rule, we established that payment for MNT services furnished in
the institutional setting, including hospital outpatient departments
(HOPDs), would be made under the PFS, not under the hospital Outpatient
Prospective Payment System (OPPS) (66 FR 55279).
During the PHE for COVID-19, outpatient therapy services, DSMT, and
MNT could be furnished via a telecommunications system to
[[Page 78886]]
beneficiaries in their homes, and bills for these services were
submitted and paid either separately or as part of a bundled payment,
when either personally provided by the billing practitioner or provided
by institutional staff and billed for by institutions, such as HOPDs,
SNFs, and HHAs. For professionals, CMS used waiver authority to expand
the range of practitioners that can serve as distant site practitioners
for Medicare telehealth services as described in section 1834(m)(4)(E)
of the Act and Sec. 410.78 (b)(2), as well as to waive the originating
site requirements for Medicare telehealth services described in section
1834(m)(4)(C) of the Act. This allowed for outpatient therapy services
to be furnished and billed by therapists in private practice, as well
as for outpatient therapy services, DSMT, and MNT to be furnished via
Medicare telehealth to beneficiaries in urban, as well as rural, areas,
including to beneficiaries located in their homes.
When therapists (PTs, OTs and SLPs) were added as distant site
telehealth practitioners using waiver authority during the PHE for
COVID-19, CMS generally took the position for services furnished in
HOPDs that waiver authority was needed to allow hospitals to bill for
services furnished by hospital staff through communication technology
to beneficiaries in their homes. CMS implemented the Hospitals Without
Walls (HWW) policy that relied on waiver authority, which allowed
hospitals to reclassify patients' homes as part of the hospital. HWW
allowed hospitals to bill two different kinds of fees for services
furnished remotely to patients in their homes: (1) hospital facility
payment in association with professional services billed under the PFS;
and (2) single payment for a limited number of practitioner services,
when statute or other applicable rules only allow the hospital to bill
for services personally provided by their staff. These services are
either billed by hospitals or by professionals, there would not be
separate facility and professional billing. This latter category
includes outpatient therapy services, DSMT, and MNT. However, while
maintaining that waiver authority was needed to allow hospital billing
for these services, CMS also issued guidance instructing HOPDs to bill
using modifiers consistent with those used for Medicare telehealth
services. For further background, we refer readers to https://www.cms.gov/files/document/03092020-covid-19-faqs-508.pdf. In the same
referenced document, CMS also issued specific guidance for other
institutional providers of therapy services to use modifier 95
(indicating a Medicare telehealth service), along with the specific
bill types for outpatient therapy services furnished by their staff.
The CAA, 2023 extended many of the flexibilities that were
available for Medicare telehealth services during the PHE for COVID-19
under emergency waiver authorities, including adding physical and
occupational therapists and speech-language pathologists as distant
site practitioners through the end of CY 2024. In developing post-PHE
guidance, CMS initially took the position that institutions billing for
services furnished remotely by their employed practitioners (where the
practitioners do not bill for their own services), would end with the
PHE for COVID-19 along with the HWW waivers. However, after reviewing
input from interested parties, as well as relevant guidance, including
applicable billing instructions, we are considering whether certain
institutions, as the furnishing providers, can bill for certain
remotely furnished services personally performed by employed
practitioners.
b. Proposal To Extend Billing Flexibilities for Certain Remotely
Furnished Services Through the End of CY 2024 and Comment Solicitation
While we consider how we might address this ambiguity in future
rulemaking, in the interests of maintaining access to outpatient
therapy, DSMT, and MNT services furnished remotely by institutional
staff to beneficiaries in their homes consistent with the accessibility
of these services when furnished by professionals via Medicare
telehealth, we proposed to continue to allow institutional providers to
bill for these services when furnished remotely in the same manner they
have during the PHE for COVID-19 through the end of CY 2024. We sought
comment on current practice for these services when billed, including
how and to what degree they continue to be provided remotely to
beneficiaries in their homes. We sought comment as to whether these
services may fall within the scope of Medicare telehealth at section
1834(m) of the Act or if there are other relevant authorities CMS might
consider in future rulemaking.
For DSMT specifically, the clinical staff personally delivering the
service may be a type of practitioner authorized to furnish Medicare
telehealth services under section 1834(m) of the Act; but we also
understand that DSMT may be provided by other types of staff.
Accordingly, we noted in sub-regulatory guidance that we are exercising
enforcement discretion in reviewing the telehealth eligibility status
of the practitioner personally providing any part of a remotely
furnished DSMT service, so long as the persons were otherwise qualified
to provide the service. For more background we refer readers to https://www.cms.gov/files/document/frequently-asked-questions-cms-waivers-flexibilities-and-end-covid-19-public-health-emergency.pdf.
As we review our telehealth policies following the end of the PHE
for COVID-19, and consider care delivery and beneficiary access
concerns raised by practitioners and beneficiary advocates, we broadly
considered billing and payment for telehealth services in institutional
settings, including when these services are furnished by practitioners
who have reassigned their rights to bill under and receive payment from
the Medicare program (billing rights) to an institution. We acknowledge
that one such setting where this billing arrangement exists includes
Critical Access Hospitals (CAHs), where a practitioner has reassigned
their billing rights to the CAH, and CMS makes payment for the
practitioner's services under an optional payment method, referred to
as CAH method II (Pub. 100-04, Chapter 4, Section 250.2). We note that
in situations when a practitioner is furnishing a telehealth service
and has reassigned their billing rights to a CAH under Method II, CMS
makes payment for the telehealth service at the same rate generally
paid for other in-person services (100 percent of the PFS payment
amount) rather than the payment amount established under the optional
method as discussed in Pub. 100-04, Chapter 4, Section 250.2. We are
interested in and solicited comment on how telehealth services
furnished under CAH method II arrangements are furnished, and whether
they would be most accurately characterized in the context of section
1834(m) of the Act or services of the CAH under Method II.
Comment: Many commenters supported our proposal to continue to
allow institutional providers to provide remote outpatient PT, OT, SLP,
DSMT, and MNT services in patients' homes through CY 2024. Some of
these commenters told us these services are invaluable for their
patients who cannot attend on-site services due to, for example, a
mobility impairment, cancer-related fatigue, they reside in rural and
underserved areas that are less accessible and lack caregiver transport
to the healthcare facility.
Response: We appreciate the commenters support and feedback.
[[Page 78887]]
Comment: Several commenters supported our proposal for outpatient
physical therapy, occupational therapy, and speech-language pathology
services being furnished by other institutional providers of Part B
services--including comprehensive outpatient rehabilitation facilities,
rehabilitation agencies, skilled nursing facilities, outpatient
hospitals, critical access hospitals (CAHs) and home health agencies
(HHAs) (for individuals not under a HH plan of care)--and their being
able to continue to bill for these services when furnished remotely
through CY 2024 in the same manner they have during the COVID-19 PHE
and CY 2023. Several of these commenters requested that CMS clarify how
to document the use of telehealth on the institutional claim form (UB-
04), since it lacks a POS field. These commenters requested that CMS
permit the use of the 95 modifier and instruct contractors to accept
modifier 95 for telehealth on the institutional claim. Several
commenters requested that if the 95 modifier could not be used that it
would cause unsustainable organizational realignment (that is,
different workflows, EHR modules, billing processes, accounting
systems, etc.) to migrate hospital-based therapists to CMS-1500 claims
forms.
Response: We clarify that it is not necessary to migrate claims for
PT, OT, or SLP services provided in institutional settings, including
the hospital, to the 1500 claim form. This is because of statutory
provisions that require (a) therapists in private practice to furnish
services only in their offices and in an individual's home (section
1861(p) of the Act for outpatient PT services (and through sections
1861(g) and 1861(ll)(2) of the Act for outpatient OT and SLP services,
respectively)), (b) institutional providers to bill for them (sections
1833(a)(8) and (9) of the Act), and (c) CMS to make payment for them at
PFS rates (section 1834(k)(3) of the Act). As we will finalize below,
CMS will instruct institutional providers to use the 95 modifier on the
1450 claim form (UB-04) for these services.
Comment: A number of commenters responded to our request for
information about their current practice of billing for these services,
such as how much they continue to provide remotely. One commenter
stated that although there has been a significant reduction in the
number of services furnished as telehealth, 10-20 percent of these
services are currently provided via telehealth by their hospital. The
same commenter stated that these telehealth therapies allow patients
throughout the State increased access to care. Another commenter stated
they are located in a health professional shortage area where people
oftentimes drive for hours to reach their center for in-person
treatment--they currently provide services to between 500-700 patients
per day via telehealth. Another commenter stated that their post-acute
telehealth program (launched in 2018) in response to CMS's
Comprehensive Care for Joint Replacement (CJR) program is on pace for
more than 5,500 telehealth PT visits in 2023, slightly less than those
in 2022. This commenter also transitioned some of their in-person
visits to telehealth during the COVID-19 PHE declining each year after
2020 when it was ~35 percent of telehealth services decreased to 9
percent, 5 percent, and 4 percent of total visits in 2021 through 2023,
respectively. Many commenters, while not specifying the amount of
outpatient therapy, DSMT, and/or MNT services they furnish, remarked
that patients would lose an invaluable resource should their ability to
bill for these services as telehealth be discontinued. Additionally,
some commenters cited studies to show the efficacy of telehealth
services.
Response: We appreciate the commenters feedback.
Comment: Many commenters questioned whether these services may fall
within the scope of Medicare telehealth at section 1834(m) of the Act
or if there are other authorities that might be relevant for us to
consider in future rulemaking. Some commenters requested that CMS make
these flexibilities permanent and urged CMS to work with Congress to
gain the statutory authority needed for the institutional settings to
provide these important services via telehealth. Several commenters
agreed that the telehealth/virtual outpatient therapy, DSMT and MNT
services furnished by staff in outpatient hospitals and other
facilities appropriately fall within the scope of Medicare telehealth
at section 1834(m) of the Act. We also heard from several commenters
that suggested we create new remote G-codes for all these services to
be billed through the OPPS starting January 1, 2025.
Response: We thank the many commenters for their feedback.
Comment: Some commenters requested that CMS provide additional
clarity in the final rule on how institutional providers should bill
for these services in CY 2024, including the specific use of modifiers.
Several of these commenters questioned if these instructions would be
different from the CMS subregulatory policy found in the online
instruction given for CY 2023, which did not include the use of a
modifier. The commenters stated that the instruction essentially
states: ``Through the end of CY2023, hospital and other providers of
PT, OT, SLP, DSMT, and MNT services that remain on the telehealth list,
can continue to bill for these services when furnished remotely in the
same way they have been during the PHE, except that beneficiaries'
homes will no longer need to be registered as provider-based
departments of the hospital to allow for hospitals to bill for these
services.''
Response: The commenters are correct that our billing policy for CY
2024 will reflect the online billing policy for CY 2023 that is found
at: https://www.cms.gov/files/document/hospitals-and-cahs-ascs-and-cmhcs-cms-flexibilities-fight-covid-19.pdf. However, with respect to
the use of modifiers, we are clarifying that for services furnished
beginning in CY 2024 that we require the use of the 95 modifier to be
applied to claims from outpatient hospitals, as soon as hospitals can
update their systems--in addition to the continued use of the 95
modifier for outpatient therapy services discussed above for all other
institutional providers furnishing outpatient therapy services via
telehealth under Part B. This policy will facilitate our ability to
track all services in the same manner. Although we did not receive
comments specifically from CAHs electing Method II, these CAHs will
continue their longstanding practice of using the GT/GQ modifier, as
appropriate.
In addition, we received several public comments that were outside
the scope of the proposals made in the CY 2024 PFS proposed rule.
Consequently, we did not summarize or respond to those comments.
After reviewing the comments, we are finalizing our proposal, with
one amendment for modifiers, to allow outpatient hospitals and other
providers of physical therapy, occupational therapy, and speech-
language pathology, DSMT and MNT services that remain on the Medicare
Telehealth Services List for CY 2024 to bill for these services when
furnished remotely in the same way they have been during the COVID-19
PHE and through the end of CY 2023, including that for hospitals,
beneficiaries' homes will no longer need to be registered as provider-
based departments of the hospital to allow for hospitals to bill for
these services. Additionally, our final subregulatory policy requires
all institutional providers that bill for therapy, DSMT, and/or MNT
services, with the exception of Method II CAHs, to apply the 95
modifier on each applicable line if these services are furnished via
telecommunication technology once
[[Page 78888]]
hospitals that need to do so can update their systems. For CAHs opting
for payment under Method II, these CAHs will continue their long-
standing practice of using the GT/GQ modifier, as appropriate, when
billing for their services furnished via telehealth.
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 the proposed rule, Potentially Misvalued Services
under the PFS. Historically, when we received RUC recommendations, our
process had been to establish interim final RVUs for the potentially
misvalued codes, new codes, and any other codes for which there were
coding changes in the final rule with comment period for a year. Then,
during the 60-day period following the publication of the final rule
with comment period, we accepted public comment about those valuations.
For services furnished during the calendar year following the
publication of interim final rates, we paid for services based upon the
interim final values established in the final rule. In the final rule
with comment period for the subsequent year, we considered and
responded to public comments received on the interim final values, and
typically made any appropriate adjustments and finalized those values.
In the CY 2015 PFS final rule with comment period (79 FR 67547), we
finalized a new process for establishing values for new, revised and
potentially misvalued codes. Under the new process, we include proposed
values for these services in the proposed rule, rather than
establishing them as interim final in the final rule with comment
period. Beginning with the CY 2017 PFS proposed rule (81 FR 46162), the
new process was applicable to all codes, except for new codes that
describe truly new services. For CY 2017, we proposed new values in the
CY 2017 PFS proposed rule for the vast majority of new, revised, and
potentially misvalued codes for which we received complete RUC
recommendations by February 10, 2016. To complete the transition to
this new process, for codes for which we established interim final
values in the CY 2016 PFS final rule with comment period (81 FR 80170),
we reviewed the comments received during the 60-day public comment
period following release of the CY 2016 PFS final rule with comment
period (80 FR 70886), and re-proposed values for those codes in the CY
2017 PFS proposed rule.
We considered public comments received during the 60-day public
comment period for the proposed rule before establishing final values
in the CY 2017 PFS final rule. As part of our established process, we
will adopt interim final values only in the case of wholly new services
for which there are no predecessor codes or values and for which we do
not receive recommendations in time to propose values.
As part of our obligation to establish RVUs for the PFS, we
thoroughly review and consider available information including
recommendations and supporting information from the RUC, the Health
Care Professionals Advisory Committee (HCPAC), public commenters,
medical literature, Medicare claims data, comparative databases,
comparison with other codes within the PFS, as well as consultation
with other physicians and healthcare professionals within CMS and the
Federal Government as part of our process for establishing valuations.
Where we concur that the RUC's recommendations, or recommendations from
other commenters, are reasonable and appropriate and are consistent
with the time and intensity paradigm of physician work, we proposed
those values as recommended. Additionally, we continually engage with
interested parties, including the RUC, with regard to our approach for
accurately valuing codes, and as we prioritize our obligation to value
new, revised, and 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
[[Page 78889]]
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 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 deemed our
actions in adjusting the recommended work RVUs as inappropriate; other
interested parties have also expressed general concerns with CMS
refinements to RUC-recommended values in general. In the CY 2017 PFS
final rule (81 FR 80272 through 80277), we responded in detail to
several comments that we received regarding this issue. In the CY 2017
PFS proposed rule (81 FR 46162), we requested comments regarding
potential alternatives to making adjustments that would recognize
overall estimates of work in the context of changes in the resource of
time for particular services; however, we did not receive any specific
potential alternatives. As described earlier in this section,
crosswalks to key reference or similar
[[Page 78890]]
codes are one of the many methodological approaches we have employed to
identify potential values that reconcile the RUC-recommend work RVUs
with the recommended time values when the RUC-recommended work RVUs did
not appear to account for significant changes in time.
We received several comments regarding our methodologies for work
valuation in response to the CY 2024 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).
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 2024 PFS final
rule, CPT codes 76987 (Intraoperative epicardial cardiac (e.g.,
echocardiography) ultrasound for congenital heart disease, diagnostic;
including placement and manipulation of transducer, image acquisition,
interpretation and report), 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), and 99497 (Advance
care planning including the explanation and discussion of advance
directives such as standard forms (with completion of such forms, when
performed), by the physician or other qualified health care
professional; first 30 minutes, face-to-face with the patient, family
member(s), and/or surrogate) all share the same total work time of 40
minutes. However, these codes had very different proposed work RVUs of
1.62, 1.00 and 1.50, 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).
[[Page 78891]]
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.
Comment: Several commenters raised the issue of the refinement
panel which was last reformed in CY 2016. Commenters stated that the
refinement panel was not obsolete and was not mutually exclusive with
the change to include all proposed valuations in each year's proposed
rule. Commenters stated that for 2 decades, the refinement panel
process was considered by interested parties to be an appeals process
and its elimination discontinued CMS' reliance on outside interested
parties to provide accountability through a transparent appeals
process. Commenters requested that CMS consider these issues and create
an objective, transparent and consistently applied formal appeals
process that would be open to any commenting organization.
Response: We did not propose any changes to the refinement panel
for CY 2024. As we stated in the CY 2016 PFS final rule (80 FR 70917
and 70918), the refinement panel was established to assist us in
reviewing the public comments on CPT codes with interim final work RVUs
and in balancing the interests of the specialty societies who commented
on the work RVUs with the budgetary and redistributive effects that
could occur if we accepted extensive increases in work RVUs across a
broad range of services. When developing the CY 2016 proposed rule, and
continuing to the present, we did not believe that the refinement panel
had generally served as the kind of ``appeals'' or reconsideration
process that some interested parties envisioned in their comments. We
also believe that the refinement panel was not achieving its intended
purpose. Rather than providing us with additional information, balanced
across specialty interests, to assist us in establishing work RVUs, the
refinement panel process generally served to rehash the issues raised
and information already discussed at the RUC meetings and considered by
CMS. In contrast to the prior process of establishing interim final
values and using a refinement panel process that generally was not
observed by members of the public, we continue to believe that the
current process of proposing the majority of code values in a proposed
rule, giving the public the opportunity to comment on those proposed
values, and then finalizing those values in a final rule offers greater
transparency and accountability.
We also note that we did not finalize our proposal to eliminate the
refinement panel completely in CY 2016. We retain the ability to
convene refinement panels for codes with interim final values under
circumstances where additional input provided by the panel is likely to
add value as a supplement to notice and comment rulemaking. We also
remind interested parties that we have established an annual process
for the public nomination of potentially misvalued codes. This process,
described in the CY 2012 PFS final rule (76 FR 73058), provides an
annual means for those who believe that values for individual services
are inaccurate and should be readdressed through notice and comment
rulemaking to bring those codes to our attention.
In response to comments, in the CY 2019 PFS final rule (83 FR
59515), we clarified that terms ``reference services'', ``key reference
services'', and ``crosswalks'' as described by the commenters are part
of the RUC's process for code valuation. These are not terms that we
created, and we do not agree that we necessarily must employ them in
the identical fashion for the purposes of discussing our valuation of
individual services that come up for review. However, in the interest
of minimizing confusion and providing clear language to facilitate
feedback from interested parties, we stated that we would seek to limit
the use of the term, ``crosswalk,'' to those cases where we are making
a comparison to a CPT code with the identical work RVU. (83 FR 59515)
We note that we also occasionally make use of a ``bracket'' for code
valuation. A ``bracket'' refers to when a work RVU falls between the
values of two CPT codes, one at a higher work RVU and one at a lower
work RVU.
We look forward to continuing to engage with interested parties and
commenters, including the RUC, as we prioritize our obligation to value
new, revised, and potentially misvalued codes; and we will continue to
welcome feedback from all interested parties regarding valuation of
services for consideration through our rulemaking process. We refer
readers to the detailed discussion in this section of the valuation
considered for specific codes. Table 14 contains a list of codes and
descriptors for which we are finalizing work RVUs for CY 2024; this
includes all codes for which we received RUC recommendations by
February 10, 2023. The proposed work RVUs, work time and other payment
information for all CY 2024 payable codes are available on the CMS
website under downloads for the CY 2024 PFS final 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
[[Page 78892]]
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 15 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 14 result in changes under the $0.35
threshold and would be unlikely to result in a change to the RVUs.
We note that the direct PE inputs for CY 2024 are displayed in the
CY 2024 direct PE input files, available on the CMS website under the
downloads for the CY 2024 PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. The inputs displayed there have been
used in developing the CY 2024 PE RVUs as displayed in Addendum B.
b. Common Refinements
(1) Changes in Work Time
Some direct PE inputs are directly affected by revisions in work
time. Specifically, changes in the intraservice portions of the work
time and changes in the number or level of postoperative visits
associated with the global periods result in corresponding changes to
direct PE inputs. The direct PE input recommendations generally
correspond to the work time values associated with services. We believe
that inadvertent discrepancies between work time values and direct PE
inputs should be refined or adjusted in the establishment of proposed
direct PE inputs to resolve the discrepancies.
(2) Equipment Time
Prior to CY 2010, the RUC did not generally provide CMS with
recommendations regarding equipment time inputs. In CY 2010, in the
interest of ensuring the greatest possible degree of accuracy in
allocating equipment minutes, we requested that the RUC provide
equipment times along with the other direct PE recommendations, and we
provided the RUC with general guidelines regarding appropriate
equipment time inputs. We appreciate the RUC's willingness to provide
us with these additional inputs as part of its PE recommendations.
In general, the equipment time inputs correspond to the service
period portion of the clinical labor times. We clarified this principle
over several years of rulemaking, indicating that we consider equipment
time as the time within the intraservice period when a clinician is
using the piece of equipment plus any additional time that the piece of
equipment is not available for use for another patient due to its use
during the designated procedure. For those services for which we
allocate cleaning time to portable equipment items, because the
portable equipment does not need to be cleaned in the room where the
service is furnished, we do not include that cleaning time for the
remaining equipment items, as those items and the room are both
available for use for other patients during that time. In addition,
when a piece of equipment is typically used during follow-up
postoperative visits included in the global period for a service, the
equipment time will also reflect that use.
We believe that certain highly technical pieces of equipment and
equipment rooms are less likely to be used during all of the preservice
or postservice tasks performed by clinical labor staff on the day of
the procedure (the clinical labor service period) and are typically
available for other patients even when one member of the clinical staff
may be occupied with a preservice or postservice task related to the
procedure. We also noted that we believe these same assumptions will
apply to inexpensive equipment items that are used in conjunction with
and located in a room with non-portable highly technical equipment
items since any items in the room in question will be available if the
room is not being occupied by a particular patient. For additional
information, we 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
[[Page 78893]]
database for new, revised, and potentially misvalued codes. However,
some recommendations include supply or equipment items that are not
currently in the direct PE input database. In these cases, the RUC has
historically recommended that a new item be created and has facilitated
our pricing of that item by working with the specialty societies to
provide us copies of sales invoices. For CY 2024 we received invoices
for several new supply and equipment items. Tables 17 and 18 detail the
invoices received for new and existing items in the direct PE database.
As discussed in section II.B. of this 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 17 and 18 also include the number of
invoices received and the number of nonfacility allowed services for
procedures that use these equipment items. We provide the nonfacility
allowed services so that interested parties will note the impact the
particular price might have on PE relativity, as well as to identify
items that are used frequently, since we believe that interested
parties are more likely to have better pricing information for items
used more frequently. A single invoice may not be reflective of typical
costs, and we encourage interested parties to provide additional
invoices so that we might identify and use accurate prices in the
development of PE RVUs.
In some cases, we do not use the price listed on the invoice that
accompanies the recommendation because we identify publicly available
alternative prices or information that suggests a different price is
more accurate. In these cases, we include this in the discussion of
these codes. In other cases, we cannot adequately price a newly
recommended item due to inadequate information. Sometimes, no
supporting information regarding the price of the item has been
included in the recommendation. In other cases, the supporting
information does not demonstrate that the item has been purchased at
the listed price (for example, vendor price quotes instead of paid
invoices). In cases where the information provided on the item allows
us to identify clinically appropriate proxy items, we might use
existing items as proxies for the newly recommended items. In other
cases, we include the item in the direct PE input database without any
associated price. Although including the item without an associated
price means that the item does not contribute to the calculation of the
final PE RVU for particular services, it facilitates our ability to
incorporate a price once we obtain information and are able to do so.
(6) Service Period Clinical Labor Time in the Facility Setting
Generally speaking, our direct PE inputs do not include clinical
labor minutes assigned to the service period because the cost of
clinical labor during the service period for a procedure in the
facility setting is not considered a resource cost to the practitioner
since Medicare makes separate payment to the facility for these costs.
We address code-specific refinements to clinical labor in the
individual code sections.
(7) Procedures Subject to the Multiple Procedure Payment Reduction
(MPPR) and the OPPS Cap
We noted that the list of services for the upcoming calendar year
that are subject to the MPPR on diagnostic cardiovascular services,
diagnostic imaging services, diagnostic ophthalmology services, and
therapy services; and the list of procedures that meet the definition
of imaging under section 1848(b)(4)(B) of the Act, and therefore, are
subject to the OPPS cap; are displayed in the public use files for the
PFS proposed and final rules for each year. The public use files for CY
2024 are available on the CMS website under downloads for the CY 2024
PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. For more
information regarding the history of the MPPR policy, we refer readers
to the CY 2014 PFS final rule with comment period (78 FR 74261 through
74263).
Effective January 1, 2007, section 5102(b)(1) of the Deficit
Reduction Act of 2005 (Pub. L. 109-171) (DRA) amended section
1848(b)(4) of the Act to require that, for imaging services, if--(i)
The TC (including the TC portion of a global fee) of the service
established for a year under the fee schedule without application of
the geographic adjustment factor, exceeds (ii) The Medicare OPD fee
schedule amount established under the prospective payment system (PPS)
for HOPD services under section 1833(t)(3)(D) of the Act for such
service for such year, determined without regard to geographic
adjustment under paragraph (t)(2)(D) of such section, the Secretary
shall substitute the amount described in clause (ii), adjusted by the
geographic adjustment factor [under the PFS], for the fee schedule
amount for such TC for such year. As required by section 1848(b)(4)(A)
of the Act, for imaging services furnished on or after January 1, 2007,
we cap the TC of the PFS payment amount for the year (prior to
geographic adjustment) by the Outpatient Prospective Payment System
(OPPS) payment amount for the service (prior to geographic adjustment).
We then apply the PFS geographic adjustment to the capped payment
amount. Section 1848(b)(4)(B) of the Act defines imaging services as
``imaging and computer-assisted imaging services, including X-ray,
ultrasound (including echocardiography), nuclear medicine (including
PET), magnetic resonance imaging (MRI), computed tomography (CT), and
fluoroscopy, but excluding diagnostic and screening mammography.'' For
more information regarding the history of the cap on the TC of the PFS
payment amount under the DRA (the ``OPPS cap''), we refer readers to
the CY 2007 PFS final rule with comment period (71 FR 69659 through
69662).
For CY 2024, we identified new and revised codes to determine which
services meet the definition of ``imaging services'' as defined
previously in this final rule for purposes of this cap. Beginning for
CY 2024, we proposed to include the following services on the list of
codes to which the OPPS cap applies: CPT codes 76883 (Ultrasound,
nerve(s) and accompanying structures throughout their entire anatomic
course in one extremity, comprehensive, including real-time cine
imaging with image documentation, per extremity), 76984 (Ultrasound,
intraoperative thoracic aorta (e.g., epiaortic), diagnostic), 76987
(Intraoperative epicardial cardiac (e.g., echocardiography) ultrasound
for congenital heart disease, diagnostic; including placement and
manipulation of transducer), 76988 (Intraoperative epicardial cardiac
(e.g., echocardiography) ultrasound for congenital heart disease,
diagnostic; placement, manipulation of transducer, and image
acquisition only), 76989 (Intraoperative epicardial cardiac (e.g.,)
[[Page 78894]]
echocardiography) ultrasound for congenital heart disease, diagnostic;
interpretation and report only), 93584 (Venography for congenital heart
defect(s), including catheter placement, and radiological supervision
and interpretation; anomalous or persistent superior vena cava when it
exists as a second contralateral superior vena cava, with native
drainage to heart (List separately in addition to code for primary
procedure)), 93585 (Venography for congenital heart defect(s),
including catheter placement, and radiological supervision and
interpretation; azygos/hemi-azygos venous system (List separately in
addition to code for primary procedure)), 93586 (Venography for
congenital heart defect(s), including catheter placement, and
radiological supervision and interpretation; coronary sinus (List
separately in addition to code for primary procedure)), 93587
(Venography for congenital heart defect(s), including catheter
placement, and radiological supervision and interpretation; venovenous
collaterals originating at or above the heart (e.g., from innominate
vein) (List separately in addition to code for primary procedure)), and
93588 (Venography for congenital heart defect(s), including catheter
placement, and radiological supervision and interpretation; venovenous
collaterals originating below the heart (e.g., from the inferior vena
cava) (List separately in addition to code for primary procedure)). We
believe that these codes meet the definition of imaging services under
section 1848(b)(4)(B) of the Act, and thus, should be subject to the
OPPS cap. We note that we previously proposed to add CPT code 76883 to
the list of codes to which the OPPS cap applies in the CY 2023 PFS
proposed rule, but we did not finalize its addition, noting that it was
not within the statutory scope of services to which the OPPS cap
applies, as it could not be split into professional and technical
components at that time (87 FR 69475). Since that time, we have
reinstated CPT code 76883's PC/TC split based on feedback from billing
practitioners, therefore we proposed to add it to the OPPS cap list for
CY 2024.
Comment: Some 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. Commenters also noted that this service falls outside the
scope of the definition of ``imaging services'' under the DRA. One
commenter stated that, while it may be appropriate for the technical
components of CPT codes 92227 (Imaging of retina for detection or
monitoring of disease; with remote clinical staff review and report,
unilateral or bilateral) and 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)
to be on the OPPS Cap List, the same logic does not apply to CPT code
92229 despite all three codes being in the same family of codes and
representing the same imaging service, only differentiated by the
modality of review and interpretation.
Response: We appreciate the commenters' feedback regarding CPT code
92229. We note that CPT codes 92227, 92228, and 92229 have been subject
to the OPPS cap since their addition to the OPPS cap list for CY 2021
and we did not make any proposals related to CPT code 92229 for CY
2024, therefore these comments are considered to be out of scope of the
proposed rule. We will consider the commenters' suggestions for future
rulemaking.
We did not receive public comments on the proposed additions to the
OPPS cap list for CY 2024. 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 2024
(1) Dorsal Sacroiliac Joint Arthrodesis (CPT Code 27278)
In September 2022, CPT deleted category III CPT code 0775T
(Arthrodesis, sacroiliac joint, percutaneous, with image guidance,
includes placement of intra-articular implant(s) (e.g., bone
allograft[s], synthetic device[s]) and created a new Category I CPT
code 27278 (Arthrodesis, sacroiliac joint, percutaneous, with image
guidance, including placement of intra-articular implant(s) (e.g., bone
allograft[s], synthetic device[s]), without placement of transfixation
device), which was surveyed for the January 2023 RUC meeting. CPT codes
27279 (Arthrodesis, sacroiliac joint, percutaneous or minimally
invasive (indirect visualization), with image guidance, includes
obtaining bone graft when performed, and placement of transfixing
device) and 27280 (Arthrodesis, sacroiliac joint, open, includes
obtaining bone graft, including instrumentation, when performed) were
added as family codes to the level of interest (LOI) form for the RUC
to review. However, the specialty societies indicated that they do not
consider CPT codes 27279 and 27280 as part of the same code family and
requested that they not be re-reviewed by the RUC for the January 2023
meeting. The RUC agreed with the specialty societies and did not review
these codes at the January 2023 meeting. The RUC stated in their
recommendations for 27278 that the clinical nature of CPT codes 27279
and 27280 is extensively disparate from 27278 for both the surgical
approach and the specialties that perform the procedures. Additionally,
they stated that no substantive changes were made to CPT codes 27279
and 27280 at the September 2022 CPT panel meeting and 27279 has been
reviewed by the RUC as recently as 2018.
We proposed the RUC-recommended work RVU of 7.86 for CPT code
27278. We also proposed the RUC-recommended direct PE inputs without
refinement.
Comment: Several commenters supported CMS' proposed valuation of
7.86 work RVUs for CPT code 27278. They also supported CMS' proposed
RUC-recommended direct PE inputs for the non-facility site of service
as they noted that current study data has sufficiently demonstrated
safety and efficacy in the non-facility setting. However, several
commenters expressed concern that the non-facility site of service is
not appropriate for this procedure. They stated that the procedure is
new and without a pre-established safety record.
Response: We thank commenters for their support of our proposed
work RVU and non-facility direct PE inputs. However, we also
acknowledge other commenters' concerns regarding CPT code 27278 being
performed in the non-facility setting. At this time, we agree with the
RUC's recommended valuations, including the non-facility direct PE
inputs. However, given consideration of all comments received, we
believe that CPT code 27278 could benefit from additional future review
by the RUC, as a service that includes a new technology supply item
(dorsal SI joint arthrodesis implant), as well as considerations for
the site of service. If we were to receive new RUC recommendations at a
future date, we would consider that information and any discussions
with interested parties for rulemaking.
Comment: Some commenters expressed concerns about the cost of the
direct PE supply item, dorsal SI joint arthrodesis implant, valued at
$11,500.
[[Page 78895]]
They stated that the high cost of this supply will negatively impact PE
RVUs and cause undesirable effects on the PFS budget neutrality as a
service with one of the highest costs on the fee schedule. Commenters
were also concerned with the potential overutilization of the service
in the non-facility setting.
Response: The payment for the dorsal SI joint arthrodesis implant
is based on invoices received from the manufacturer and a formal review
to determine if each direct PE input is typical and medically
necessary, which is part of our standard code review process. While we
acknowledge that the supply is a high-cost item, we do not believe it
is appropriate to undervalue a service to minimize impacts on budget
neutrality. We also remind commenters that the utilization for this new
CPT category I code is crosswalked from CPT code 0775T. As such, we do
not anticipate a large impact on budget neutrality and will continue to
monitor utilization as part of our standard ratesetting process.
After consideration of the public comments, we are finalizing the
RUC-recommended work RVU of 7.86 and direct PE inputs as proposed for
CPT code 27278.
(2) Vertebral Body Tethering (CPT Codes 22836, 22837, and 22838)
At the September 2022 CPT Panel meeting, two new Category I CPT
codes, 22836 (Anterior thoracic vertebral body tethering, including
thoracoscopy, when performed; up to 7 vertebral segments) and 22837
(Anterior thoracic vertebral body tethering, including thoracoscopy,
when performed; 8 or more vertebral segments) were established for
thoracic tethering. In addition, another new Category I CPT code, 22838
(Revision (e.g., augmentation, division of tether), replacement, or
removal of thoracic vertebral body tethering, including thoracoscopy,
when performed) was established for tether revision, replacement or
removal. This code family was then surveyed for the January 2023 RUC
meeting.
We proposed the RUC-recommended work RVUs of 32.00 for CPT code
22836, 35.50 for CPT code 22837, and 36.00 for CPT code 22838. We also
proposed the RUC-recommended direct PE inputs without refinement.
Comment: We received comments in support of the 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 our work RVU
and direct PE inputs for the codes in the Vertebral Body Tethering
family as proposed.
(3) Total Disc Arthroplasty (CPT Codes 22857 and 22860)
In September 2021, the CPT Editorial Panel created CPT Category I
code 22860 to describe Total disc arthroplasty (artificial disc),
anterior approach, including discectomy to prepare interspace (other
than for decompression); second interspace, lumbar (List separately in
addition to code for primary procedure) and replace CPT Category III
code 0163T (Total disc arthroplasty (artificial disc), anterior
approach, including discectomy to prepare interspace (other than for
decompression), each additional interspace, lumbar (List separately in
addition to code for primary procedure)), which prompted CPT codes
22860 and 22857 (Total disc arthroplasty (artificial disc), anterior
approach, including discectomy to prepare interspace (other than for
decompression); single interspace, lumbar) to be surveyed for the
January 2022 RUC meeting. At the January 2022 RUC meeting, the
specialty societies indicated, and the RUC agreed, that the survey
results for both CPT codes 22857 and 22860 were erroneous and that the
codes should be resurveyed for the April 2022 RUC meeting. Therefore,
we proposed and finalized to maintain the RUC-recommended work RVU of
27.13 for CPT code 22857 and contractor pricing for CPT code 22860 for
CY 2023.
For CY 2024, we proposed the April 2022 RUC-recommended work RVU of
27.13 for CPT code 22857, which represents no change from the current
work RVU. For CPT code 22860, we disagreed with the April 2022 RUC-
recommended survey median work RVU of 7.50 and proposed the survey
(with experience) 25th percentile work RVU of 6.88. We noted that, of
the 46 ZZZ-codes with an intraservice time of 60 minutes, only 4 have a
work RVU higher than the RUC-recommended 7.50.
We noted that our proposed work RVU of 6.88 will maintain
relativity with CPT codes 22552 (Arthrodesis, anterior interbody,
including disc space preparation, discectomy, osteophytectomy and
decompression of spinal cord and/or nerve roots; cervical below C2,
each additional interspace (List separately in addition to code for
primary procedure)) (work RVU = 6.50, 45 minutes intra-service and 50
minutes total time), which is an anterior approach spine procedure that
requires less time, and CPT code 22208 (Osteotomy of spine, posterior
or posterolateral approach, 3 columns, 1 vertebral segment (e.g.,
pedicle/vertebral body subtraction); each additional vertebral segment
(List separately in addition to code for primary procedure)) (work RVU
= 9.66, 120 minutes intra-service and 135 minutes total time). As the
RUC mentioned in their recommendations, these codes appropriately
bracket CPT code 22860 and demonstrate relativity among similar
surgical spine add-on codes. The RUC noted that their recommended work
RVU of 7.50 reflects the increased intensity of spine procedures
performed from an anterior approach, but we note that CPT code 22226
(Osteotomy of spine, including discectomy, anterior approach, single
vertebral segment; each additional vertebral segment (List separately
in addition to code for primary procedure)), which represents an
anterior approach, and CPT code 22216 (Osteotomy of spine, posterior or
posterolateral approach, 1 vertebral segment; each additional vertebral
segment (List separately in addition to primary procedure)), which
represents a posterior or posterolateral approach, are both valued at
6.03 work RVUs and have identical IWPUTs of 0.1005. CPT codes 22216 and
22226 are ZZZ codes and have identical times as CPT code 22860, and
therefore, we believe the proposed survey (with experience) 25th
percentile work RVU of 6.88 for CPT code 22860 is more appropriate than
the RUC recommended work RVU.
We proposed the RUC-recommended direct PE inputs for both codes
without refinement.
Comment: Some commenters disagreed with the proposed work RVU of
6.88 for CPT code 22860 and encouraged CMS to finalize the RUC-
recommended work RVU of 7.50. Some commenters reiterated that CPT codes
22552 and 22208 appropriately bracket CPT code 22860, with work RVUs of
6.50 and 9.66, respectively. Some commenters also stated that the
exposure of the second interspace (represented by CPT code 22860) is
technically more difficult than the initial interspace (represented by
CPT code 22857) and more intense compared to an osteotomy of the spine
(represented by CPT codes 22208 and 22226). Commenters generally
disagreed with the comparison of CPT code 22860 to CPT codes 22216 and
22226 because they were valued over 25 years ago and had limited survey
responses.
Response: We agree with the commenters that the intensity of the
second interspace exposure (CPT code 22860) is greater than the
identically timed CPT code 22226, which represents an anterior approach
osteotomy of the spine, and the technical difficulty of the first
interspace exposure (CPT code 22857). The proposed work RVU of 6.88 for
CPT
[[Page 78896]]
code 22860 accurately values the surgeon's 60 minutes of intraservice
time more than the identical 60 minutes of intraservice time for CPT
code 22226 and yields a higher intensity (IWPUT) of 0.115 for CPT code
22860 for the exposure of the second interspace compared to exposure of
the first interspace in CPT code 22857 of 0.092. Commenters were
supportive of bracketing a work RVU of 7.50 with CPT codes 22552 and
22208, with work RVUs of 6.50 and 9.66, respectively, but we note that
the proposed work RVU of 6.88 is also appropriately bracketed by these
codes as well.
After consideration of the public comments, we are finalizing a
work RVU of 27.13 for CPT code 22857 and a work RVU of 6.88 for CPT
code 22860, as proposed. We are also finalizing the direct PE inputs as
proposed.
(4) Phrenic Nerve Stimulation System (CPT Codes 33276, 33277, 33278,
33279, 33280, 33281, 33287, 33288, 93150, 93151, 93152, and 93153)
In September 2022, the CPT Editorial Panel created eight new
Category I CPT codes to describe the insertion, repositioning, removal,
and removal and replacement of a phrenic nerve stimulator system, as
well as adding four additional new Category I codes to describe
activation, interrogation, and programming of a phrenic nerve
stimulator system. These new codes will replace thirteen Category III
codes, 0424T-0436T. The twelve new Category I codes were surveyed and
then reviewed for the January 2023 RUC meeting.
We proposed the RUC-recommended work RVU for all twelve codes in
the Phrenic Nerve Stimulation System family. We proposed a work RVU of
9.50 for CPT code 33276 (Insertion of phrenic nerve stimulator system
(pulse generator and stimulating lead[s]) including vessel
catheterization, all imaging guidance, and pulse generator initial
analysis with diagnostic mode activation when performed), a work RVU of
5.43 for CPT code 33277 (Insertion of phrenic nerve stimulator
transvenous sensing lead), a work RVU of 9.55 for CPT code 33278
(Removal of phrenic nerve stimulator including vessel catheterization,
all imaging guidance, and interrogation and programming, when
performed; system, including pulse generator and lead(s)), a work RVU
of 5.42 for CPT code 33279 (Removal of phrenic nerve stimulator
including vessel catheterization, all imaging guidance, and
interrogation and programming, when performed; transvenous stimulation
or sensing lead(s) only), a work RVU of 3.04 for CPT code 33280
(Removal of phrenic nerve stimulator including vessel catheterization,
all imaging guidance, and interrogation and programming, when
performed; pulse generator only), a work RVU of 6.00 for CPT code 33281
(Repositioning of phrenic nerve stimulator transvenous lead(s)), a work
RVU of 6.05 for CPT code 33287 (Removal and replacement of phrenic
nerve stimulator including vessel catheterization, all imaging
guidance, and interrogation and programming when performed; pulse
generator), a work RVU of 8.51 for CPT code 33288 (Removal and
replacement of phrenic nerve stimulator including vessel
catheterization, all imaging guidance, and interrogation and
programming when performed; transvenous stimulation or sensing lead), a
work RVU of 0.85 for CPT code 93150(Therapy activation of implanted
phrenic nerve stimulator system including all interrogation and
programming), a work RVU of 0.80 for CPT code 9X046 (Interrogation and
programming (minimum one parameter) of implanted phrenic nerve
stimulator systemX047 (), and a work RVU of 0.43 for CPT code 93153
(Interrogation, without programming of implanted phrenic nerve
stimulator system).
We proposed to refine the CA039 Post-operative visits (total time)
for CPT code 33287 from 36 minutes to 53 minutes to reflect the fact
that this code has a Level 4 office visit and not a Level 3 office
visit included in its global period; we believe that this was an
unintended technical error in the RUC recommendation. We also proposed
to refine the equipment time for the exam table (EF023) equipment from
36 minutes to 53 minutes for CPT code 33287 to conform to this change
in clinical labor time. For all other codes, we proposed the direct PE
inputs as recommended by the RUC without refinement.
Comment: Several commenters stated that they supported the CMS
proposal of the RUC's recommended work RVUs for all twelve codes in the
family. Several commenters also stated that they agreed with the
correction of a clerical error in the CA039 Post-operative visits
(total time) for CPT code 33287 and otherwise supported the CMS
proposal of the RUC's recommended direct PE inputs.
Response: We appreciate the support for our proposals from the
commenters.
After consideration of the public comments, we are finalizing the
work RVUs and direct PE inputs for the code family as proposed.
(5) Posterior Nasal Nerve Ablation (CPT Codes 30117, 30118, 31242, and
31243)
In September 2022, the CPT Editorial Panel created two new
endoscopy codes for ablation of the posterior nasal nerve: CPT code
31242 (Nasal/sinus endoscopy, surgical; with destruction by
radiofrequency ablation, posterior nasal nerve), and CPT code 31243
(Nasal/sinus endoscopy, surgical; with destruction by cryoablation,
posterior nasal nerve). In preparation for the January 2023 RUC
meeting, both new posterior nasal nerve codes, 31242 and 31243, as well
as family CPT codes 30117 and 30118, were surveyed. For CY 2024, the
RUC recommended a work RVU of 3.91 for CPT code 30117, a work RVU of
9.55 for CPT code 30118, and a work RVU of 2.70 for both CPT codes
31242 and 31243.
We proposed the RUC-recommended work RVU of 3.91 for CPT code
30117. We proposed to remove the clinical labor for the CA037 (Conduct
patient communications) activity code for CPT code 30117. This clinical
labor is associated with patient communications which already take
place during the CA036 (Discharge day management) activity code for 10-
day and 90-day global procedures. We proposed to remove this clinical
labor as it would be duplicative with the communications already taking
place under the CA036 activity code. We proposed to delete supply item
SB027 (gown, staff, impervious) because supply items SA042 (pack,
cleaning and disinfecting, endoscope) and SA043 (pack, cleaning,
surgical instruments) each include this same item. Supply items SA042
and SA043 are both included in the direct PE inputs for CPT code 30117.
We disagreed with the RUC-recommended work RVU of 9.55 for CPT code
30118 and proposed a work RVU of 7.75, based on a direct crosswalk from
CPT code 28298 (Correction, hallux valgus (bunionectomy), with
sesamoidectomy, when performed; with proximal phalanx osteotomy, any
method) which has the same 60 minutes of intra-service time and similar
total time as CPT code 30118. We believe the work RVU should be lower
than the RUC recommendation of 9.55 to reflect the decrease in intra-
service time from 105 minutes to 60 minutes, and the decrease in total
time from 288 minutes to 211 minutes. In the case of CPT code 30118,
the intra-service work time is decreasing by 43 percent and the total
work time is decreasing by 27 percent but the RUC-recommended work RVU
is only decreasing by 4 percent. Although we do not imply that the
decrease in time
[[Page 78897]]
as reflected in survey values must equate to a one-to-one or linear
decrease in the valuation of work RVUs, we believe that since the two
components of work are time and intensity, significant decreases in the
surveyed work time should be reflected in commensurate decreases to
work RVUs.
We also noted that at the RUC-recommended work RVU of 9.55, the
intensity of CPT code 30118 would be increasing by more than 50
percent. We disagreed that there would be such a significant increase
in the intensity for the procedure, as it is transitioning from
inpatient to outpatient status which suggests that the intensity has
remained the same or decreased over time. We also disagreed that this
would be the case since the intensity for CPT code 30117 is decreasing
at the RUC-recommended work RVU of 3.91. Therefore, we also proposed a
work RVU of 7.75 because it maintains the current intensity of CPT code
30118 instead of resulting in an increase in intensity. The work RVU of
7.75 is supported by the reference CPT codes we compared to CPT code
30118 with the same 60 minutes of intra-service time and similar total
time as CPT code 30118; reference CPT code 11970 (Replacement of tissue
expander with permanent implant) has a work RVU of 7.49, and reference
CPT code 19325 (Breast augmentation with implant) has a work RVU of
8.12. We believe the RVU of 7.75 is a more appropriate value overall
than 9.55 when compared to the range of codes with the same intra-
service time and similar total time.
We proposed to remove the clinical labor for the CA037 (Conduct
patient communications) activity code for CPT code 30118. This clinical
labor is associated with patient communications which already take
place during the CA036 (Discharge day management) activity code for 10-
day and 90-day global procedures. We proposed to remove this clinical
labor from CPT code 30118 as it would be duplicative with the
communications already taking place under the CA036 activity code.
We proposed the RUC-recommended work RVU of 2.70 for CPT codes
31242 and 31243. Both CPT codes 31242 and 31243 are endoscopic
procedures; therefore, we proposed CPT code 31231 (Nasal endoscopy,
diagnostic, unilateral or bilateral (separate procedure)) as the
endoscopic base code for both of these codes because the description of
these procedures includes what is described for CPT code 31231, with
the additional component of the posterior nasal nerve ablation. Both of
these procedures are performed with an endoscope. CPT codes 31242 and
31243 are not add-on codes, and both have a 0-day global period. The
endoscopic base code that we are assigning to CPT codes 31242 and 31243
is used in a specific type of multiple procedure payment reduction that
applies to some endoscopy codes.
We proposed to refine the RUC-recommended direct PE inputs for both
CPT codes 31242 and 31243. For CPT code 31242, we are refining the
equipment time for the ES031 equipment (scope video system (monitor,
processor, digital capture, cart, printer, LED light)) from 39 minutes
to 32 minutes. The RUC used the CA025 (clean scope) time of 10 minutes
instead of the CA024 (clean room/equipment by clinical staff) time of 3
minutes in the Scope Systems formula, when the time for CA024 is the
standard; we believe that this was an unintended technical error in the
RUC recommendation. We are similarly refining the equipment time for
ES031 from 39 minutes to 34 minutes for CPT code 31243.
For CPT code 31243, we are refining the equipment time for the
ES040 equipment (PROXY endoscope, rigid, sinoscopy (0 degrees)) from 39
minutes to 41 minutes because the RUC used 18 minutes of intra-service
time for CA018 (Assist physician or other qualified healthcare
professional--directly related to physician work time (100%)) instead
of 20 minutes in the standard Scope formula. Also, for both CPT codes
31242 and 31243, we proposed to delete supply item SB027 (gown, staff,
impervious) because SA042 (pack, cleaning and disinfecting, endoscope)
and SA043 (pack, cleaning, surgical instruments) each include this same
item. Supply items SA042 and SA043 are both included in the PE inputs
for CPT codes 31242 and 31243.
The following is a summary of the comments we received and our
responses.
Comment: Commenters supported CMS' proposal of the RUC-recommended
work RVUs for CPT codes 30117, 31242, and 31243.
Response: We thank the commenters for their support, and we are
finalizing the RUC-recommended work RVU of 3.91 for CPT code 30117, and
the work RVU of 2.70 for CPT codes 31242 and 31243, as proposed.
Comment: For CPT code 30118, we received a few comments that
disagreed with CMS' proposed work RVU of 7.75. The commenters stated
that the proposed work RVU of 7.75 fails to maintain relativity within
the code family of CPT codes 30117, 30118, 31242 and 31243, and it does
not account for the higher clinical complexity and intraoperative
intensity for CPT code 30118. Commenters stated that the intra-service
time required for CPT code 30118 is twice as long as CPT code 30117,
which is attributable to the difficulty of this procedure. One
commenter stated that the intensity (IWPUT) for CPT code 30118 is
0.079, which is more than four times the typical intensity of work
compared to the IWPUT of 0.018 for CPT code 30117. Commenters stated
that the proposed CMS crosswalk of CPT code 28298 was completely
inappropriate in terms of intensity, and the skill needed to perform
CPT code 30118 is greater than CPT code 28298. Although CPT code 28298
has similar intra-service time and total time, it has an IWPUT of 0.047
which is considerably less than the IWPUT for CPT code 30118. In
addition, commenters stated that the two comparison codes that CMS
chose as support for the CPT code 28298 crosswalk (CPT codes 11970 and
19325) do not compare in intensity to CPT code 30118, even though they
have similar intra-service time and total time. Commenters also stated
that CPT code 30118 was undervalued in terms of its intensity during
the initial Harvard valuation.
Response: We disagree with the commenters and continue to believe
that a direct crosswalk from CPT code 28298 is appropriate since it has
the same 60 minutes of intra-service time and similar total time as CPT
code 30118. We also 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.
The work RVU for CPT code 30118 should be lower than the RUC
recommendation of 9.55 to reflect the decrease in intra-service time
from 105 minutes to 60 minutes, and the decrease in total time from 288
minutes to 211 minutes. Although we do not imply that the decrease in
time as reflected in survey values must equate to a one-to-one or
linear decrease in the valuation of work RVUs, we believe that since
the two components of work are time and intensity, significant
decreases in the surveyed work time should be reflected in commensurate
decreases to work RVUs.
The intensity of CPT code 30118 would increase by more than 50
percent with the RUC-recommended RVU of 9.55. However, we disagree that
the intensity for CPT code 30118 would increase in such a significant
way
[[Page 78898]]
because this procedure is transitioning from an inpatient to an
outpatient status. We also note that the intensity for CPT code 30117
has decreased with the RUC-recommended work RVU of 3.91. Therefore, we
believe that our proposed work RVU of 7.75, which maintains the current
intensity of CPT code 30118 instead of resulting in an increase in
intensity, is the most accurate valuation for this service. We continue
to believe that the proposed work RVU of 7.75 is a more appropriate
value overall than the RUC's recommended work RVU of 9.55 when compared
to the range of codes with the same intra-service time and similar
total time. Therefore, we are finalizing the proposed work RVU of 7.75
for CPT code 30118.
Comment: For CPT code 31243, one commenter disagreed with the scope
video system PE input equipment time refinement from 39 minutes to 34
minutes for ES031 and requested that we accept the RUC recommendation
of 39 minutes, which they stated was the appropriate value for this
input.
Response: We disagree with the commenter. The standard Scope
Systems equipment formula the RUC used was incorrect. For CPT code
31243, the RUC initially recommended 39 minutes for PE input ES031.
However, the RUC used the CA025 clinical labor task instead of CA024 in
the formula; this was in error since CA024 is in the standard Scope
Systems formula and CA025 is not. Using CA024 results in 7 minutes less
time for ES031. Also, the RUC inadvertently used 18 minutes of intra-
service time for CA018 in the formula instead of 20 minutes. Using the
correct time of 20 minutes for CA018 results in an increase of 2
minutes. The net result of these corrections is 34 minutes for ES031
((39 + 2)-7 = 34). We also note that the RUC comments on the PE inputs
for CPT code 31243 agreed with our proposed refinement for ES031.
Therefore, for CPT code 31243 we are finalizing the equipment time
refinement of 34 minutes for ES031 as proposed.
Comment: For CPT codes 30117 and 30118, some commenters disagreed
with the proposal to remove the clinical labor for the CA037 activity
code from the direct PE inputs. Commenters stated that this is a
follow-up phone call by staff to see how the patient is doing, 1 to 2
days after the procedure, and should be included in both the facility
and non-facility settings. The commenters stated that this staff
contact with the patient is completely different than, and separate
from, what occurs the day of the procedure for CA036. While a follow-up
phone call is outside of the 090-day global standard, this type of
postoperative communication is evolving and reflects best practice.
Response: We continue to believe that the CA037 clinical labor task
should not be included in the PE inputs for CPT codes 30117 and 30118
since the standard for the post-operative period for 010-day and 090-
day global procedures does not include clinical labor for phone calls
as a separate direct PE input, and both of these codes are 090-day
global procedures. We also continue to believe that CA037 is
duplicative with the communications already taking place under the
CA036 clinical labor activity. Therefore, we are finalizing the PE
input refinement to remove the CA037 clinical labor from CPT codes
30117 and 30118.
After consideration of the public comments, we are finalizing the
work RVU values for the Posterior Nasal Nerve Ablation code family (CPT
codes 30117, 30118, 31242, and 31243) as proposed. We are also
finalizing the direct PE inputs for CPT codes 30117, 30118, 31242, and
31243 as proposed.
(6) Cystourethroscopy With Urethral Therapeutic Drug Delivery (CPT Code
52284)
In September 2022, the CPT Editorial Panel replaced Category III
code 0499T (Cystourethroscopy, with mechanical dilation and urethral
therapeutic drug delivery for urethral stricture or stenosis, including
fluoroscopy, when performed) with the new Category I CPT code 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) to
describe cystourethroscopy with mechanical urethral dilation and
urethral therapeutic drug delivery. For CY 2024, the RUC recommended a
work RVU of 3.10 for CPT code 52284.
We proposed the RUC-recommended work RVU of 3.10 for CPT code
52284. We also proposed the RUC-recommended direct PE inputs for CPT
code 52284 without refinement.
Since this is an endoscopic procedure, we proposed CPT code 52000
(Cystourethroscopy (separate procedure)) as the endoscopic base code
for CPT code 52284 because the description of this procedure includes
what is described for CPT code 52000 with the additional component of
the urethral therapeutic drug delivery. This procedure is performed
with a cystoscope. CPT code 52284 is not an add-on code, it has a 0-day
global period. The endoscopic base code that we assigned to CPT code
52284 is a specific type of multiple procedure payment reduction that
applies to some endoscopy codes.
The following is a summary of the comments we received and our
responses.
Comment: The commenters supported CMS' proposal of the RUC-
recommended work RVU and direct PE inputs.
Response: We thank the commenters for their support and are
finalizing as proposed.
After consideration of the public comments, we are finalizing the
work RVU of 3.10 for the CPT code 52284 as proposed. We are also
finalizing the direct PE inputs for code 52284 without refinement.
(7) Transcervical RF Ablation of Uterine Fibroids (CPT Code 58580)
In September 2022, the CPT Editorial Panel deleted Category III
code 0404T (Transcervical uterine fibroid(s) ablation with ultrasound
guidance, radiofrequency) and created a new Category I CPT code 58580
(Transcervical ablation of uterine fibroid(s), including intraoperative
ultrasound guidance and monitoring, radiofrequency) to report and
describe transcervical radiofrequency ablation of uterine fibroid(s)
which prompted CPT code 58580 to be surveyed for the January 2023 RUC
meeting. At the January 2023 RUC meeting, the specialty societies
indicated, and the RUC agreed, that the survey results for CPT code
58580 showed that the survey 25th percentile work RVU of 7.21
appropriately recognizes the work involved in this service.
We proposed the RUC-recommended work RVU of 7.21 for CPT code
58580. We note that the RUC recommended in their review that CPT code
58580 be placed on the New Technology list to be re-reviewed by the RUC
in 3 years to ensure correct valuation and utilization assumptions. We
will revisit the valuations of CPT code 58580 in future rulemaking as
needed, based on our typical annual review process.
CPT code 58580 includes a medium instrument pack (EQ138) as one of
the practice expense inputs for this code. Since the medium instrument
pack is classified as equipment, it should include time for cleaning
the surgical instrument package. We noted a mistake in one of the
equipment time formulas for the medium instrument pack (EQ138), which
used the CA024 clean room/equipment by clinical staff time instead of
the CA026 clean surgical instrument package time in the equipment
formula. Therefore, we proposed to refine the medium
[[Page 78899]]
instrument pack equipment time from 65 minutes to 77 minutes to conform
to our established policy for surgical instrument packs; otherwise, we
proposed the RUC-recommended direct PE inputs without refinement.
Comment: Several commenters supported the CMS proposal of the RUC-
recommended work RVU of 7.21. Commenters also agreed with the proposed
refinement to the medium instrument pack (EQ138) equipment time.
Response: We appreciate the support for our proposed policies from
the commenters.
Comment: A few commenters disagreed with the CMS proposal of the
RUC-recommended work RVU of 7.21 for CPT code 58580. The commenters
stated that the RUC's recommendation of a work RVU of 7.21 for this
procedure was insufficient and suggested that CPT code 58674, to which
CMS has assigned a work RVU of 14.08, would be more appropriate.
Another commenter suggested that CMS increase the work RVU for CPT code
58580 to 8.00 to bring the valuation in line with CPT code 22514, which
has a work RVU of 7.99 and which the RUC used as a comparator code.
Response: We thank the commenters for their suggestions; however we
disagree with the commenters and continue to agree with the RUC that a
work RVU of 7.21 is the most accurate valuation for CPT code 58580. The
suggestion from commenters to assign a work RVU of 14.08 based on a
crosswalk to CPT code 58674 would not be appropriate for CPT code
58580, as CPT code 58674 is a surgical laparoscopy with more than
double the intraservice work time. The alternate suggestion of
finalizing a work RVU of 8.00 based on a near-match of CPT code 22514
is a better fit, as this code shares the same intraservice work time
and similar total work time with CPT code 58580. However, we believe
that CPT code 22514 is a more intensive procedure as compared with CPT
code 58580 due to its nature as a percutaneous vertebral augmentation,
which justifies having a higher work RVU.
At the January 2023 RUC meeting, the specialty societies indicated,
and the RUC agreed, that the survey results for CPT code 58580 showed
that the survey 25th percentile work RVU of 7.21 appropriately
recognizes the work involved in this service. To justify a work RVU of
7.21, the RUC also referenced top key reference code CPT code 58356
(Endometrial cryoablation with ultrasonic guidance, including
endometrial curettage, when performed) with a work RVU= 6.41, intra-
service time of 45 minutes, total time of 167 minutes, and noted that
although both services involve identical intra-service time, the
majority of survey respondents that selected this key reference code
indicated the surveyed code was a more intense and complex service to
perform (94 percent). While we do not always agree with the RUC, we
believe that the proposed work RVU of 7.21 accurately captures the work
completed in this service.
Comment: One commenter stated that the proposed non-facility
practice expense RVU for CPT code 58580 would be insufficient for the
costs expected in an office setting.
Response: We appreciate the concerns raised by the commenter;
however, the commenter did not specify which additional PE expenses
were not being captured in the proposed valuation for CPT code 58580.
If the commenter has reason to believe that the RUC's recommended
direct PE inputs failed to capture the costs associated with this
procedure, we encourage them to consider nominating CPT code 58580 as
potentially misvalued for addition review. (We direct readers to the
Potentially Misvalued Services Under the PFS (section II.C.) earlier in
this final rule for additional details).
Comment: Several commenters recommended that CMS increase the
malpractice RVU for CPT code 58580, as they stated that the proposed
value was insufficient to cover malpractice costs.
Response: The malpractice RVU for each service is a derived
valuation largely based on the work RVU and the risk factors associated
with the specialties reporting that service in claims data. We do not
propose specific malpractice RVUs which are derived as a result of our
larger ratesetting process; for additional information, we direct
readers to the Determination of Malpractice Relative Value Units (RVUs)
(section II.H.) in last year's final rule (87 FR 69634 through 69641).
After consideration of the public comments for CPT code 58580, we
are finalizing the RUC-recommended work RVU of 7.21 as proposed. We are
also finalizing our proposal to refine the medium instrument pack
equipment time from 65 minutes to 77 minutes to conform to our
established policy for surgical instrument packs. Otherwise, we are
finalizing the RUC-recommended direct PE inputs without refinement.
(8) Suprachoroidal Injection (CPT Code 67516)
In September 2022, the CPT Editorial Panel introduced category I
CPT code 67516 as a new code. CPT code 67516 describes suprachoroidal
injection, which is the injection of medication into the space between
the choroid and the sclera of the eye with procedure-specific needles
and an injection kit. CPT code 67516 replaces temporary category III
CPT code 0465T (Suprachoroidal injection of a pharmacologic agent (does
not include supply of medication)), which was contractor priced. While
there are other existing general CPT codes for injections to the eye,
the AMA RUC is adding CPT code 67516 (Suprachoroidal space injection of
pharmacologic agent (separate procedure) (Report medication
separately)) to describe a more specific service to better distinguish
this procedure from the rest of the codes for eye injections in this
family. CPT code 67516 is a 000-day global code and currently, there is
only one FDA-approved medication to treat macular edema associated with
uveitis which is reported separately with HCPCS J-code J3299
triamcinolone acetonide (Xipere[supreg]).
We proposed the RUC-recommended work RVU of 1.53 for CPT code
67516. We also proposed the RUC-recommended direct PE inputs for the
code without refinement.
Comment: We received a few comments for CPT code 67516 in favor of
establishing this code as a permanent category I code with active
pricing. We received no comments opposing CPT code 67516.
Response: We thank commenters for taking the time to submit
comments.
After reviewing the comments, we are finalizing the proposed work
RVU and direct PE inputs for CPT code 67516.
(9) Skull Mounted Cranial Neurostimulator (CPT Codes 61889, 61891, and
61892)
In February 2022, the CPT Editorial Panel created codes 61889,
61891, and 61892 to describe Skull-Mounted Cranial Neurostimulator, and
these codes were surveyed for the October 2022 RUC meeting.
We proposed the RUC-recommended work RVU of 25.75 for CPT code
61889 (Insertion of skull-mounted cranial neurostimulator pulse
generator or receiver, including craniectomy or craniotomy, when
performed, with direct or inductive coupling, with connection to depth
and/or cortical strip electrode array(s)), the RUC-recommended work RVU
of 11.25 for CPT code 61891 (Revision or replacement of skull-mounted
cranial neurostimulator pulse generator or receiver with connection to
depth and/or cortical strip electrode array(s)), and the RUC-
recommended work RVU of 15.00 for CPT code 61892 (Removal of
[[Page 78900]]
skull-mounted cranial neurostimulator pulse generator or receiver with
cranioplasty, when performed).
We proposed the RUC-recommended direct PE inputs for CPT codes
61889, 61891, and 61892 without refinement.
We did not receive comments on our proposals. We are finalizing as
proposed the RUC-recommended work RVU and PE inputs for CPT codes
61889, 61891, and 61892 respectively.
(10) Spinal Neurostimulator Services (CPT Codes 63685, 63688, 64596,
64597, and 64598)
For CPT codes 63685 (Insertion or replacement of spinal
neurostimulator pulse generator or receiver requiring pocket creation
and connection between electrode array and pulse generator or receiver)
and 63688 (Revision or removal of implanted spinal neurostimulator
pulse generator or receiver, with detachable connection to electrode
array) we proposed the RUC-recommended work RVUs of 5.19 and 4.35,
respectively. We proposed the RUC-recommended direct PE inputs for CPT
codes 63685 and 63688 without refinement.
We agreed with the RUC recommended contractor pricing for CPT codes
64596 (Insertion or replacement of percutaneous electrode array,
peripheral nerve, with integrated neurostimulator including imaging
guidance, when performed; initial electrode array), 64597 (Insertion or
replacement of percutaneous electrode array, peripheral nerve, with
integrated neurostimulator including imaging guidance, when performed;
each additional electrode array), and 64598 (Revision or removal of
neurostimulator electrode array, peripheral nerve, with integrated
neurostimulator); and we proposed contractor pricing for these three
codes.
Comment: One commenter disagreed with the proposed work RVU of 4.35
for CPT code 63688, stating that the current work RVU of 5.30 is more
appropriate. This commenter stated, without further explanation, that
the valuation of the revision code should be greater than the initial
insertion, as it is more complex to revise or remove an existing
implant than to insert a new implant.
Response: We appreciate the feedback, but we note that the RUC's
Summary of Recommendations (SOR) for CPT code 63688 contained two key
reference codes that appropriately support the proposed valuation.
Without additional data provided by the commenter, we continue to
believe that the RUC-reviewed survey 25th percentile work RVU of 4.35
accurately reflects the time and intensity of CPT code 63688.
Comment: Several commenters stated that they supported the proposal
of the RUC-recommended work RVUs and direct PE inputs for CPT codes
63685 and 63688. These commenters also supported our proposal to assign
contractor pricing to CPT codes 64596, 64597, and 64598.
Response: We appreciate the support for our proposals from
commenters.
After consideration of all comments on our proposals for CPT codes
63685 and 63688, we are finalizing the RUC-recommended work RVUs of
5.19 and 4.35, respectively. We are finalizing the RUC-recommended
direct PE inputs for CPT codes 63685 and 63688 without refinement. We
are also finalizing the RUC-recommended contractor pricing for CPT
codes 64596, 64597, and 64598 as proposed.
(11) Neurostimulator Services-Bladder Dysfunction (CPT Codes 64590 and
64595)
For CPT codes 64590 (Insertion or replacement of peripheral,
sacral, or gastric neurostimulator pulse generator or receiver,
requiring pocket creation and connection between electrode array and
pulse generator or receiver) and 64595 (Revision or removal of
peripheral, sacral, or gastric neurostimulator pulse generator or
receiver, with detachable connection to electrode array) we proposed
the RUC-recommended work RVUs of 5.10 and 3.79, respectively.
We requested clarification on the direct PE inputs for CPT code
64590 in the non-facility setting. Specifically, we believed the RUC
inadvertently proposed 56 minutes of equipment time for the EQ114
equipment (electrosurgical generator), instead of 48 minutes using the
default formula for calculating equipment time. We believed that 48
minutes of equipment time for EQ114 was appropriate and matched the
clinical labor time; therefore, we proposed 48 minutes for the EQ114
equipment for CPT code 64590. We also believed that the EQ209 equipment
(programmer, neurostimulator (w-printer)) was intended to match the
same 84 minutes of equipment time listed for the EF031 power table as
both were indicated to be used during the follow-up office visit.
Therefore, we proposed 84 minutes of equipment time for EQ209 for CPT
code 64590.
We proposed the remaining RUC-recommended direct PE inputs for CPT
code 64590 without refinement. We also proposed the RUC-recommended
direct PE inputs for CPT code 64595 without refinement.
Comment: The RUC agreed with the proposed 48 minutes of equipment
time for the EQ114 equipment, and 84 minutes of equipment time for
EQ209 for CPT code 64590.
Response: We appreciate the additional information provided by the
RUC to clarify the equipment time.
Comment: Several commenters stated that they supported the proposal
of the RUC-recommended work RVUs and direct PE inputs for CPT codes
64590 and 64595.
Response: We appreciate the support for our proposed work RVUs and
direct PE inputs from the commenters.
After consideration of all comments on our proposals for CPT codes
64590 and 64595, we are finalizing the RUC-recommended work RVUs of
5.10 and 3.79, respectively. We are finalizing 48 minutes of equipment
time for EQ114 and 84 minutes of equipment time for EQ209 for CPT code
64590. We are also finalizing the remaining RUC-recommended direct PE
inputs for CPT codes 64590 and 64595 as proposed.
(12) Ocular Surface Amniotic Membrane Placement/Reconstruction (CPT
Codes 65778, 65779, and 65780)
CPT code 65778 (Placement of amniotic membrane on the ocular
surface; without sutures) was identified by the Relativity Assessment
Workgroup (RAW) via the high-volume growth screen for codes with
Medicare utilization over 10,000 screen. During the September 2022 RAW
meeting, the specialty societies stated that CPT codes 65778, 65779
(Placement of amniotic membrane on the ocular surface; single layer,
sutured), and 65780 (Ocular surface reconstruction; amniotic membrane
transplantation, multiple layers) would be surveyed for the January
2023 RUC meeting.
For CY 2024, we proposed the RUC-recommended work RVUs for all
three CPT codes. We proposed a work RVU of 0.84 for CPT code 65778
(Placement of amniotic membrane on the ocular surface; without
sutures), a work RVU of 1.75 for CPT code 65779 (Placement of amniotic
membrane on the ocular surface; single layer, sutured), and a work RVU
of 7.03 for CPT code 65780 (Ocular surface reconstruction; amniotic
membrane transplantation, multiple layers). We also proposed the RUC-
recommended direct PE inputs for CPT codes 65778, 65779, and 65780
without refinement.
Comment: Several commenters disagreed with the proposed work RVU of
0.84, stating that the amniotic membrane supply product, Prokera, has
[[Page 78901]]
a higher cost than the proposed rate. These commenters also stated that
the proposed work RVU does not account for the time spent explaining
the product at the time of insertion, and stated that the valuation
should not decrease from the current work RVU of 1.00.
Response: We did not receive additional pricing data from these
commenters to support a change in the pricing of the amniotic membrane
supply. Additionally, we did not receive information supporting a
change to the proposed work RVU. The RUC-recommended time values have
remained unchanged since the code was last valued in 2015. However, the
previous valuation was based on a crosswalk and marked not to use to
validate physician work for other services in the RUC database.
Therefore, the RUC determined that the survey 25th percentile work RVU
of 0.84 appropriately accounts for the work required to perform this
service. We continue to agree with the RUC-recommended work RVU for CPT
code 65778.
Comment: A commenter disagreed with the proposed pricing of the
human amniotic membrane allograft mounted on a non-absorbable self-
retaining ring (SD248) supply. The commenter stated that the proposed
pricing of $872.50 was not typical for the SD248 supply and submitted
more than 100 invoices to support their recommendation of increased
pricing.
Response: We appreciate the submission of such a large quantity of
invoices for more accurate pricing of the human amniotic membrane
allograft mounted on a non-absorbable self-retaining ring (SD248)
supply. The submitted invoices all displayed the identical price of
$1049 for the Prokera Plus item, and we agree with the commenter that
this is the current market price for the Prokera Plus device. However,
we disagree that using the Prokera Plus would necessarily be typical
for use in CPT code 65778. We also received invoices in the RUC's
recommended materials for this code family containing prices for the
Prokera Slim ($850) and Prokera Classic ($895) devices which the RUC
indicated would also be appropriate for use in CPT code 65778. The
manufacturer's website described the Prokera Plus as an item that
``maximizes the therapeutic benefit,'' which is intended ``for patients
who need intensive treatment.'' As a result, we do not believe it would
be appropriate to use the pricing for the Prokera Plus item for the
SD248 supply as we do not believe that it would be typical for
providers to use the most intensive and expensive product as the
standard of care. We are instead averaging together the invoice prices
of the Prokera Slim, Prokera Classic, and Prokera Plus to price the
SD248 supply at $931.33, which is an increase of $58.83 above our
proposed price of $872.50. We believe that averaging these products'
prices together will more accurately capture the market-based pricing
of the devices currently used in CPT code 65778.
After consideration of the public comments, we are finalizing the
RUC-recommended work RVUs of 0.84 for CPT code 65778, 1.75 for CPT code
65779, and 7.03 for CPT code 65780. We are finalizing $931.33 as the
price for the SD248 supply item for CPT code 65778, and the remaining
direct PE inputs for this code as proposed. We are also finalizing the
RUC-recommended direct PE inputs for CPT codes 65779 and 65780 without
refinement.
(13) Fractional Flow Reserve With CT (CPT Code 75580)
For CY 2018, the CPT Editorial Panel established four new Category
III CPT codes for fractional flow reserve derived from computed
tomography (FFRCT): CPT codes 0501T-0504T. Medicare began payment for
CPT code 0503T (Noninvasive estimated coronary fractional flow reserve
(FFR) derived from coronary computed tomography angiography data using
computation fluid dynamics physiologic simulation software analysis of
functional data to assess the severity of coronary artery disease;
analysis of fluid dynamics and simulated maximal coronary hyperemia,
and generation of estimated FFR model) in the hospital outpatient
department setting under the Outpatient Prospective Payment System
(OPPS) in CY 2018 (82 FR 59284). We typically assign contractor pricing
for Category III codes for the PFS since they are temporary codes
assigned to emerging technology and services. However, we made an
exception for FFRCT services, and we have since been trying to
understand the costs of the PE resource inputs for CPT code 0503T in
the physician's office setting. In the CY 2021 PFS final rule (85 FR
84630), we stated that we found FFRCT to be similar to other
technologies that use algorithms, artificial intelligence, or other
innovative forms of analysis to determine a course of treatment, where
the analysis portion of the service cannot adequately be reflected
under the PE methodology; and that our recent reviews for the overall
cost of CPT code 0503T had shown the costs in the physician office
setting to be similar to costs reflected in payment under the OPPS (85
FR 84630). As such, we proposed to use the geometric mean costs under
the OPPS as a proxy for CPT code 0503T and ultimately finalized
national pricing for CPT code 0503T based on a valuation crosswalk to
the technical component (TC) of CPT code 93457 in the CY 2022 PFS final
rule (86 FR 65037-65042).
For CY 2024, the CPT Editorial Panel approved the replacement of
Category III codes 0501T-0504T with a single new Category I code
(75580) to report a non-invasive estimate of coronary fractional flow
reserve derived from augmentative software analysis of the dataset from
a coronary computed tomography angiography. CPT code 75580 (Noninvasive
estimate of coronary fractional flow reserve derived from augmentative
software analysis of the data set from a coronary computed tomography
angiography, with interpretation and report by a physician or other
qualified health care professional) was reviewed at the January 2023
RUC meeting and valuation recommendations were submitted to CMS. These
recommendations include a software analysis fee for FFRCT listed as a
supply input which accounts for the overwhelming majority of the code's
valuation.
We have long had concerns that the software algorithm in the
analysis fee for CPT code 75580 is not well accounted for in our PE
methodology; however, we recognize that practitioners are incurring
resource costs for purchasing the FFRCT software and its ongoing use.
This was the rationale for our previous policy to use a crosswalk that
reflected this service's overall relative resource costs. At the same
time, we continued to consider potentially refining and updating our PE
methodology. The RUC recommendations include the previously mentioned
software analysis fee for FFRCT as a supply input. However, analysis
fees are not well accounted for in our current PE methodology. Although
we recognize that these fees are a cost for practitioners, we have not
traditionally recognized these analysis fees as forms of direct PE in
our methodology. We previously stated our belief that crosswalking the
RVUs for CPT code 0503T to a code with similar resource costs (the TC
for CPT code 93457) allowed CMS to recognize that practitioners are
incurring resource costs for the purchase and ongoing use of the
software employed in CPT code 0503T, which would not typically be
considered direct PE under our current methodology (86 FR 65038 and
65039).
[[Page 78902]]
Therefore, we proposed maintaining the previous valuation crosswalk
to the technical component of CPT code 93457 for the new FFRCT code
75580. This new Category I code is intended as a direct replacement for
Category III code 0503T, and maintaining the current crosswalk will
allow the geometric mean costs under the OPPS to continue serving as a
valuation proxy. We are specifically crosswalking the technical
component of CPT code 75580 to the technical component of CPT code
93457; we proposed the RUC-recommended work RVU of 0.75 for the
professional component of CPT code 75580, and the global component will
be comprised of their sums as usual. We also noted that there was an
error in the RUC's recommended equipment time for the Professional PACS
Workstation (ED053), which was listed at 14.5 minutes instead of the
correct 13.5 minutes based on the sum of the intraservice work time (11
minutes) plus half of the preservice work time (5 divided by 2 = 2.5
minutes).
Comment: Many commenters stated their approval of the CMS proposal
of the RUC's recommended work RVU of 0.75 for the professional
component of CPT code 75580 and the proposal to maintain the crosswalk
from CPT code 75580's predecessor code to the technical component of
CPT code 93457 for the technical component of the procedure. Commenters
stated that given the predominance of the cost of the analysis fee for
CPT code 75580, it was critical that CMS utilize something other than
the current PE methodology when establishing the physician fee schedule
rate for the procedure. Commenters stated that CMS' proposal to
continue to use the crosswalking methodology, that has been in place
since CY 2022, was an appropriate alternative for the valuation of the
technical component of CPT code 75580 and should be finalized.
Commenters stated that the proposed crosswalk to the technical
component of CPT code 93457 was an appropriate method to account for
the costs physicians incur to provide FFRCT. Many commenters detailed
the clinical benefits of FFRCT services, such as leading to a 70%
reduction in rates of heart attack, death, or unnecessary invasive
catheterization in one study, and urged CMS to finalize their proposed
policies.
Response: We appreciate the support for our proposed policies from
the commenters.
Comment: A commenter disagreed with the proposed crosswalk to the
technical component of CPT code 93457 and objected to CMS using data
from the OPPS in establishing relative values for the PFS. The
commenter stated that any proposal to use the relativity of hospital
charge data to determine the relativity of practice costs within a
physician office is not consistent with statutory provisions under
Section 4505 of the Balanced Budget Act of 1997.
Response: We disagree with the commenter and believe that we can
use OPPS data in certain circumstances to inform payment under the PFS.
As we stated in the proposed rule, our recent reviews for the overall
cost of CPT code 0503T showed the costs in the physician office setting
to be similar to those reflected in payment under the OPPS (85 FR
84630). As such, we proposed to use the geometric mean costs under the
OPPS as a proxy for CPT code 0503T and ultimately finalized national
pricing for CPT code 0503T based on a valuation crosswalk to the
technical component (TC) of CPT code 93457 in the CY 2022 PFS final
rule (86 FR 65037-65042). We then carried over this proposed policy to
CPT code 75580, the direct replacement for CPT code 0503T. We believe
this is a more accurate way to value the service due to the problems
that this service's analysis fee poses for our PE methodology.
Comment: A commenter disagreed with the proposed crosswalk to the
technical component of CPT code 93457 by stating that this crosswalk
approach was not resource-based. The commenter stated that the software
analysis fee was the only supply input and represented a per-patient,
single-use item, and thus was appropriately included as a direct
supply. The commenter recommended that CMS negate the need for a
crosswalk by accepting this software as a direct practice expense
input.
Response: As we stated in the proposed rule, we have long had
concerns that the software algorithm in the analysis fee for CPT code
75580 is not well accounted for in our PE methodology; however, we
recognize that practitioners are incurring resource costs for
purchasing the FFRCT software and its ongoing use. This was the
rationale for our previous policy to use a crosswalk (86 FR 65037
through 65042) that reflected the overall relative resource costs for
this service while we continued to consider potentially refining and
updating our PE methodology. The RUC recommendations included the
previously mentioned software analysis fee for FFRCT as a supply input.
However, analysis fees are not well accounted for in our current PE
methodology. Although we recognize that these fees are a cost for
practitioners, we have not traditionally recognized these analysis fees
as forms of direct PE in our methodology. We continue to believe that
the software analysis fee would not be considered as a form of direct
PE under our current methodology, and therefore, we proposed to
maintain the previous valuation crosswalk to the technical component of
CPT code 93457 to incorporate these costs.
Comment: Several commenters recommended that CMS separately
identify and pay for high-cost disposable supplies. Commenters stated
that creating separate high-cost supply codes would be a way to pay for
the software analysis fee included in CPT code 75580.
Response: We have received a number of prior requests from
interested parties, including the RUC, to implement 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. (For a
discussion of this issue, we direct the reader to our discussion in the
CY 2011 PFS final rule with comment period (75 FR 73251)).
After consideration of the public comments, we are finalizing our
proposal of the RUC-recommended work RVU of 0.75 for the professional
component of CPT code 75580. We are also finalizing our proposal to
crosswalk the technical component of CPT code 75580 to the technical
component of CPT code 93457, maintaining the previous crosswalk in
place for CPT code 0503T, as well as finalizing our proposed equipment
time for the Professional PACS Workstation (ED053), which was
unmentioned by commenters.
(14) Ultrasound Guidance for Vascular Access (CPT Code 76937)
To specify the insertion of a peripherally inserted central venous
catheter (PICC), the CPT Editorial Panel decided to create two new
codes: CPT code 36572 and CPT code 36573, and revised CPT codes 36568,
36569 and 36584 in September of 2017. This revision of these codes
created a scenario where these bundled services could be performed by a
clinician that performs the procedure without imaging guidance or a
radiologist that performs the procedure with imaging guidance. When
this code family was surveyed again in January 2018, CPT code 76937
(Ultrasound guidance for vascular
[[Page 78903]]
access requiring ultrasound evaluation of potential access sites,
documentation of selected vessel patency, concurrent realtime
ultrasound visualization of vascular needle entry, with permanent
recording and reporting (List separately in addition to code for
primary procedure) was identified as part of this code family. Since it
was expected that utilization of PICC procedures would decrease once
CPT code 76937 was bundled with these services, the specialty societies
that perform this service proposed to review CPT code 76937 after 2
years, once more data about these services became available. CPT code
76937 was reviewed at the October 2022 RUC meeting for CY 2024.
We proposed the RUC-recommended work RVU of 0.30 for CPT code
76937. We also proposed the RUC-recommended direct PE inputs for CPT
code 76937.
Comment: Commenters were in support of the CMS proposal of the RUC-
recommended values for CPT code 76937.
Response: We thank the commenters for their support.
After consideration of the comments, we are finalizing a work RVU
of 0.30 for CPT code 76937 as proposed. We are also finalizing the
direct PE inputs as proposed.
(15) Neuromuscular Ultrasound (CPT Codes 76881, 76882, and 76883)
Since their creation in 2011, CPT codes 76881 (Ultrasound, complete
joint (ie, joint space and peri-articular soft-tissue structures),
real-time with image documentation) and 76882 (Ultrasound, limited,
joint or other nonvascular extremity structure(s) (e.g., joint space,
peri-articular tendon[s], muscle[s], nerve[s], other soft-tissue
structure[s], or soft-tissue mass[es]), real-time with image
documentation) have been reviewed numerous times as New Technology/New
Services by the Relativity Assessment Workgroup (RAW). In October 2016,
the RAW reviewed these codes and agreed with the specialty societies
that the dominant specialties providing the complete (CPT code 76881)
versus the limited (CPT code 76882) ultrasound of extremity services
were different than originally thought, causing variation in the
typical PE inputs. The RAW recommended referral to the Practice Expense
Subcommittee for review of the direct PE inputs and the CPT Editorial
Panel to clarify the introductory language regarding the reference to
one joint in the complete ultrasound. The PE Subcommittee reviewed the
direct PE inputs for CPT codes 76881 and 76882 and adjusted the
clinical staff time at the January 2017 RUC meeting, and the CPT
Editorial Panel editorially revised CPT codes 76881 and 76882 to
clarify the distinction between complete and limited studies and
revised the introductory guidelines to clarify the reference to one
joint in the complete ultrasound procedure in June 2017.
In October 2021, the CPT Editorial Panel approved the addition of
CPT code 76883 (Ultrasound, nerve(s) and accompanying structures
throughout their entire anatomic course in one extremity,
comprehensive, including real-time cine imaging with image
documentation, per extremity) for reporting real-time, complete
neuromuscular ultrasound of nerves and accompanying structures
throughout their anatomic course, per extremity, and the revision of
CPT code 76882 to add focal evaluation. CPT codes 76881 and 76882 were
identified as part of the neuromuscular ultrasound code family with CPT
code 76883 and surveyed for the January 2022 RUC meeting. We reviewed
these recommendations for CY 2023 and discussed our concerns with the
commenters' assertions regarding typical PE inputs for CPT code 76882
in the CY 2023 PFS final rule (87 FR 69506 through 69510).
Specifically, given the changes in dominant specialty for these CPT
codes from 2010 to 2017, and again from 2017 to 2022, we recommended
that the RUC and interested parties reconsider the PE inputs for each
code based on the dominant specialty for each CPT code, based on the
most recent year's Medicare claims data, and consideration of survey
responses submitted to CMS in response to the CY 2023 PFS proposed
rule.
The PE inputs for CPT codes 76881, 76882, and 76883 were
subsequently re-reviewed at the January 2023 RUC meeting and the RUC
submitted refinements to the PE inputs for CPT code 76882 only. We
proposed the RUC-recommended PE refinements for CPT code 76882 with the
exception of the RUC-recommended 13.5 minutes for ED053 (Professional
PACS workstation) and 23 minutes for EQ250 (ultrasound unit, portable).
We noted that the old intraservice time of 11 minutes was used in error
when calculating the standard equipment time for ED053. Therefore, we
disagreed with the RUC-recommended equipment time of 13.5 minutes and
proposed 17.5 minutes for ED053, which is calculated by using the
standard equipment formula for ED053 established in the CY 2017 PFS
final rule (81 FR 80182) with the updated intraservice time from the CY
2023 PFS final rule ((0.5*5)+15 = 17.5).
We disagreed with the RUC-recommended 23 minutes of equipment time
for EQ250, which includes one minute of clinical labor time for CA014
(Confirm order, protocol exam) in the highly technical equipment
formula, as discussed beginning in the CY 2013 PFS final rule (77 FR
69028), in error. Therefore, the correct equipment time for EQ250 using
the highly technical equipment formula would be 22 minutes. However,
because the Summary of Recommendations included in the RUC
recommendations did not provide a rationale for the use of the highly
technical equipment formula for EQ250, we proposed to maintain the 15
minutes of equipment time for EQ250 for CPT code 78882, which
corresponds to the interservice time for this code and maintains
consistency with how equipment time is allotted for EQ250 across the
three codes in this family. We referred readers to the classification
of highly technical equipment in the CY 2014 PFS final rule (79 FR
67639).
The RUC did not make recommendations on the work RVUs for CPT codes
76881, 76882, and 76883, and CMS did not propose any changes.
Comment: Some commenters thanked CMS for proposing the RUC
recommended direct PE inputs for CPT code 76882. One commenter agreed
with the CMS PE refinements for CPT code 76882, including the
refinement for EQ250.
Response: We thank the commenters for their support.
Comment: Some commenters expressed continued concern about the PE
inputs for CPT code 76881, and one commenter submitted several invoices
for ultrasound machine technology used by rheumatologists for
neuromuscular ultrasound services. The commenter stated that the
clinical labor, which they believed was typically a diagnostic medical
sonographer, and the dedicated ultrasound room and high-quality
ultrasound machines utilized by rheumatologists were not appropriately
accounted for in CPT code 76881. Some commenters requested that CMS
utilize the invoices and informal survey data provided in response to
last year's CY 2023 PFS proposed rule to raise the PE values for CPT
code 76881 to match the proposed PE values of CPT code 76882 until a
formal workforce survey of typical rheumatology practice expenses has
been conducted to prevent a rank order anomaly. Multiple commenters
stated that rheumatologists' typical practice expenses are not
accounted for in the valuation of CPT code 76881, and many offered to
provide more resources to capture these expenses. Some commenters
asserted that rheumatologists were not surveyed on
[[Page 78904]]
their typical practice expense and requested a similar re-review for
CPT code 76881 that was done for CPT code 76882.
Response: As stated in the CY 2023 PFS final rule, we appreciate
the commenters' survey collection efforts to reflect rheumatologists'
costs in performing neuromuscular ultrasound and the concern regarding
the accounting of rheumatologists' typical clinical labor and equipment
in the RUC recommendations. We encourage the commenters to coordinate
with the RUC to provide their survey data to facilitate a
reconsideration of PE inputs if the commenters believe certain
specialties were not appropriately queried. Because the RUC has
standardized procedures for PE and physician surveys, and the fact that
the commenters' survey results differ so drastically from the January
2022 and 2023 RUC recommendations, we encourage the RUC and other
interested parties to consider the commenters' survey efforts. We
encourage collaboration with the RUC PE subcommittee and the submission
of specific invoices to support the surveys' results and robust data to
show the typicality of these PE inputs.
We note that the RUC submitted a letter in their January 2023
recommendations outlining the process for re-surveying these codes. The
RUC noted that PE recommendations were formulated at the January 2022
meeting based on RUC database claims at the time, which showed
Rheumatology as the highest single provider of CPT code 76881 and
Radiology as the highest single specialty provider of CPT code 76882,
although for both codes no single specialty has more than a plurality.
For the January 2023 RUC meeting, there was a change in the dominant
specialty for CPT code 76882 to Podiatry, rather than Radiology, in the
non-facility setting; therefore, the PE recommendations were adjusted
to reflect the more common hand-held ultrasound device, rather than the
ultrasound room, sonographer, and PACS workstation that are typical in
radiology practices. The RUC's letter stated that they reviewed the
several hundred letters from rheumatologists submitted in response to
the CY 2023 PFS proposed rule.
In response, the American College of Radiology, American Academy of
Neurology, American Association of Neuromuscular and Electrodiagnostic
Medicine, American Academy of Physical Medicine and Rehabilitation,
American College of Rheumatology, and American Podiatric Medical
Association convened a panel that included experts familiar with these
services and typical practice expense to reevaluate the direct practice
expense inputs for neuromuscular ultrasound. At the time of the panel,
rheumatology was the dominant specialty for CPT code 76881 at 26
percent, and radiology was the dominant specialty for CPT code 76882 at
27 percent. Because of the dominant specialty change back to radiology
for CPT code 76882, which has been the historical standard and was
temporarily changed to Podiatry based on COVID pandemic alterations of
the utilization, the RUC-recommended inputs for CPT code 76882
submitted for the January 2023 meeting reflected updated clinical
staff, clinical activities, supplies, and equipment (PACS) utilized
when performed by Radiology. The letter also stated that the expert
panel carefully considered the comments submitted to CMS regarding the
practice expense for CPT code 76881. The letter stated the following:
``While the use of dedicated sonographers is increasing in
Rheumatology, we did not believe it was yet the typical clinical staff
in the non-facility setting and will re-evaluate the issue when the
code family returns for review under the new technology process. The
expert panel recognizes that many non-radiology specialties are
increasingly adopting a ``picture archiving and communication system
(PACS)'' for image storage and important patient care. However, the RUC
has previously indicated that these are general practice expenses not
typically allocated to a single patient/code and that only the specific
use of the PACS workstation is acceptable under PE supplies. As many
PACS vendors increasingly shift to a per-patient cost, the RUC may need
to reconsider how these supplies are allocated in practice expense.''
We also remind interested parties that we have established an
annual process for the public nomination of potentially misvalued
codes. This process provides an annual means for those who believe that
values for individual services are inaccurate and should be readdressed
through notice and comment rulemaking to bring those codes to our
attention, as detailed in section II.C. of this final rule. 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.
While this process is available to interested parties, we remind
commenters that the RUC plans to review the practice expense for CPT
codes 76881, 76882, and 76883 with additional data according to their
new technology process at a future RUC meeting.
After consideration of the comments, we are finalizing the direct
PE refinements as proposed for CPT codes 76881, 76882, and 76883. We
did not propose and are not finalizing any changes to the work RVU for
CPT codes 76881, 76882, and 76883.
(16) Intraoperative Ultrasound Services (CPT Codes 76998, 76984, 76987,
76988, and 76989)
In October 2018, the Relativity Assessment Workgroup (RAW) created
a screen for CMS/Other codes with Medicare utilization of 20,000 or
more, and CPT code 76998 (Ultrasonic guidance, intraoperative) was
subsequently identified as part of that screen. When CPT code 76998 was
identified in the CMS/Other screen, it was noted that many specialties
were represented in the Medicare claims data. Specialties representing
cardiothoracic surgery, general surgery, breast surgery, urology,
interventional cardiology, interventional radiology and vascular
surgery jointly submitted an action plan that the RAW reviewed in
October 2019. Based on the variability of intraoperative ultrasound for
each specialty with differences in the typical patient and physician
work, it was decided that each society would submit applications for
new code(s) as needed to carve out the work currently reported with CPT
code 76998 until the code was no longer needed, or until it was clear
what the final dominant use of CPT code 76998 was so that a survey
could be conducted.
In October 2019, the RUC referred this issue to the CPT Editorial
Panel to clarify correct coding and accurately differentiate physician
work, as multiple specialties currently report CPT code 76998. The CPT
Editorial Panel addressed CPT code 76998 in 2020 and 2021 by adding
instructional parentheticals that restrict the use of imaging guidance
with vein ablation procedures and adding new codes that bundled imaging
guidance for urological procedures. In May 2022, the CPT Editorial
Panel created four new codes to report intraoperative cardiac
ultrasound services, thus carving out most of the prior reporting of
CPT code 76998 by cardiothoracic surgeons and cardiologists.
After utilization was removed from CPT code 76998 for vein ablation
procedures, most urological procedures, cardiac procedures, and intra-
abdominal procedures through instructions and/or new or revised codes,
it was determined that the dominant use of the code would be related to
breast surgery, allowing for
[[Page 78905]]
CPT code 76998 to be surveyed. CPT codes 76984 (Ultrasound,
intraoperative thoracic aorta (e.g., epiaortic), diagnostic), 76987
(Intraoperative epicardial cardiac (e.g., echocardiography) ultrasound
for congenital heart disease, diagnostic; including placement and
manipulation of transducer, image acquisition, interpretation and
report), 76988 (Intraoperative epicardial cardiac (e.g.,
echocardiography) ultrasound for congenital heart disease, diagnostic;
placement, manipulation of transducer, and image acquisition only),
76989 (Intraoperative epicardial cardiac (e.g., echocardiography)
ultrasound for congenital heart disease, diagnostic; interpretation and
report only), and 76998 were surveyed by the specialty societies for
the September 2022 RUC meeting.
We disagreed with the RUC-recommended work RVU of 1.20 for CPT code
76998 and proposed the total time ratio work RVU of 0.91. The RUC
recommended a 7-minute total time decrease for CPT code 76998. We
agreed with the RUC that the intensity of CPT code 76998 (real-time
during an operation) is greater than the identically-timed CPT code
76641 (Ultrasound, breast, unilateral, real time with image
documentation, including axilla when performed; complete), which
represents a single ultrasound session typically performed by a
technician, whereas CPT code 76998 includes multiple, separate
ultrasound maneuvers during a surgical procedure that require a more
intense, immediate interpretation in order to direct resection of the
breast tissue and ensure a thorough and complete surgical excision of
the abnormal breast tissue. The work RVU of 0.91 for CPT code 76998
adequately values the surgeon's 5 minutes of pre-service time, 12
minutes of intraservice time, and 5 minutes of immediate post-service
time more than the same 5, 12, and 5 minutes of the technician's time
for CPT code 76641, which has a work RVU of 0.73.
Additionally, the IWPUT of CPT code 76641 is appropriately less
than the IWPUT of CPT code 76698, with IWPUTs of 0.0422 and 0.0572,
respectively. We remind interested parties that we believe that, since
the two components of work are time and intensity, absent an obvious or
explicitly stated rationale for why the relative intensity of a given
procedure has increased, decreases in time should be reflected in
decreases to work RVUs. We disagreed with the RUC-recommended
maintenance of the current work RVU for CPT code 76998 for a few
reasons: the RUC recommendations did not advocate for a change in
intensity, and presumably some higher-intensity cardiac procedures will
no longer be reported using CPT code 76998, as they can now be reported
using CPT codes 76984 through 76989. Instead, we proposed an
appropriately lower work RVU and associated IWPUT to account for the 7-
minute decrease in total time and removal of higher-intensity cardiac
procedures previously reported by CPT code 76998. We noted that the
work RVU of 0.91 for CPT code 76998 is supported by the upper brackets
of CPT codes 72125 (Computed tomography, cervical spine; without
contrast material), 72128 (Computed tomography, thoracic spine; without
contrast material), and 72131 (Computed tomography, lumbar spine;
without contrast material), and a lower bracket of CPT code 76641. CPT
codes 72125, 72128, and 72131 represent spinal computed tomography (CT)
of the cervical, thoracic, and lumbar spine, respectively.
We proposed the RUC-recommended work RVU of 0.60 and work times of
5 minutes of pre-evaluation time, 10 minutes of intraservice time, and
3 minutes of immediate postservice time for total time of 18 minutes
for CPT code 76984. We also proposed the RUC-recommended work times for
CPT codes 76987 and 76988 of 10 minutes of pre-evaluation time and 20
minutes of intraservice time for both codes, and 5 and 10 minutes of
immediate postservice time, for total times of 40 and 35 minutes,
respectively. We proposed the RUC-recommended work times for CPT code
76989 with the exception of the intraservice time. We proposed the
survey median intraservice time of 15 minutes rather than the RUC-
recommended 75th percentile based on the assertion in the RUC's Summary
of Recommendations that the cardiologist is typically in the operating
room intraoperatively with the cardiothoracic surgeon prior to and
after the cardiac repair. Based on this assertion, we do not believe
the cardiologist spends the same amount of time in the operating room
as the cardiothoracic surgeon in CPT codes 76987 and 76988. Therefore,
we proposed 5 minutes of pre-evaluation time, 15 minutes of
intraservice time, and 10 minutes of immediate postservice time for
total time of 30 minutes for CPT code 76989.
Due to the CPT code descriptor for CPT code 76987, we believe that
the appropriate work for this service is reflected in the combined work
of CPT codes 76988 and 76989. We noted that in the CY 2015 PFS final
rule (79 FR 67669), we reviewed a similarly constructed family of codes
representing interventional transesophageal echocardiography (TEE) for
congenital cardiac anomalies in the same way by proposing and
finalizing a work RVU for CPT code 93315 (Transesophageal
echocardiography for congenital cardiac anomalies; including probe
placement, image acquisition, interpretation and report) equal to the
combined work RVUs of CPT codes 93316 (Transesophageal echocardiography
for congenital cardiac anomalies; placement of transesophageal probe
only) and 93317 (Transesophageal echocardiography for congenital
cardiac anomalies; image acquisition, interpretation and report only).
We noted that the Summary of Recommendations for CPT codes 76987
through 76989 state that these intraoperative ultrasound services are
expected to be very rare, as intraoperative TEE is considered the gold
standard and can be performed for most patients instead, which could be
reported using CPT codes 93315 through 93317. Because CPT codes 76987
through 76989 are an alternative to CPT codes 93315 through 93317 for
congenital cardiac anomalies when intraoperative TEE is
contraindicated, we believe we should maintain consistency and propose
a work RVU for CPT code 76987 that equals the combined work RVUs of CPT
codes 76988 and 76989.
Therefore, we disagreed with the RUC-recommended work RVUs of 1.90,
1.20, and 1.55 for CPT codes 76987, 76988, and 76989, respectively. We
proposed a work RVU of 1.62 for CPT code 76987 based on a crosswalk to
CPT codes 73219 (Magnetic resonance (e.g., proton) imaging, upper
extremity, other than joint; with contrast material(s)) and 78452
(Myocardial perfusion imaging, tomographic (SPECT) (including
attenuation correction, qualitative or quantitative wall motion,
ejection fraction by first pass or gated technique, additional
quantification, when performed); multiple studies, at rest and/or
stress (exercise or pharmacologic) and/or redistribution and/or rest
reinjection). We noted that this crosswalk is supported by total time
ratios between CPT code 76987 and reference CPT codes 93312
(Echocardiography, transesophageal, real-time with image documentation
(2D) (with or without M-mode recording); including probe placement,
image acquisition, interpretation and report) and 93315, which equal
1.66 and 1.67 respectively. We also noted that this is supported by a
total time ratio to
[[Page 78906]]
the current time and work RVU for the code that cardiothoracic surgeons
currently use to report this service before the creation of CPT code
76987, CPT code 76998 ((40/29)*1.20 = 1.66). Lastly, this is also
supported by a total time ratio to the same CPT code 76998 after
factoring in the updated total time of 22 minutes and our work RVU for
CPT code 76998 of 0.91 ((40/22)*0.91 = 1.65). We noted that a work RVU
of 1.62 for CPT code 76987 yields an IWPUT of 0.059, which is slightly
higher than the IWPUTs of the intraoperative TEE CPT codes 93315 and
93312 that represent the complete procedure, which are 0.0532 and
0.0580, respectively.
Similar to how CPT code 76987 is broken down into service parts by
CPT codes 76988 and 76989 to allow for multiple providers to perform
different parts of the whole service done by one provider (represented
by CPT code 76987), CPT codes 93312 through 93314 and 93315 through
93317 are broken down as well. According to the RUC Database, CPT code
93316 represents placement of transesophageal probe only, typically
performed by a cardiac anesthesiologist. CPT code 93313
(Echocardiography, transesophageal, real-time with image documentation
(2D) (with or without M-mode recording); placement of transesophageal
probe only) also represents placement of transesophageal probe only,
when performed by a cardiac anesthesiologist. Similarly, CPT code 76988
represents placement and manipulation of transducer and image
acquisition only, which is typically performed by a cardiothoracic
surgeon according to the Summary of Recommendations.
According to the RUC Database, CPT code 93317 represents image
acquisition and interpretation and report only, typically done by the
cardiologist after probe placement typically performed by the cardiac
anesthesiologist, represented by CPT code 93316. CPT code 93314
(Echocardiography, transesophageal, real-time with image documentation
(2D) (with or without M-mode recording); image acquisition,
interpretation and report only) also represents image acquisition and
interpretation and report only, typically done by the cardiologist
after probe placement typically performed by the anesthesiologist,
represented by CPT code 93313. Similarly, CPT code 76989 represents
interpretation and report only, which is typically performed by a
cardiologist according to the Summary of Recommendations.
Because this family is broken down into service parts in the same
way CPT codes 93312 through 93314 and 93315 through 93317 are, we
disagreed with the RUC's recommendation to assign work RVUs for CPT
codes 76988 and 76989 that sum to more than the aggregate work RVU for
CPT code 76987. Therefore, we proposed a work RVU of 1.08 for CPT code
76988 and a work RVU of 0.54 for CPT code 76989, which sum to the
aggregate work RVU of 1.62 for CPT code 76987. The work RVUs for CPT
code 76988 and 76989 were calculated by taking the aggregate work RVU
of the whole service, represented by CPT code 76987, and dividing by
three based on the number of discernable service parts: probe placement
and manipulation, image acquisition, and interpretation and report.
Because CPT code 76988 represents two of the three service parts
performed by a cardiothoracic surgeon, we allotted 2/3rds of the
aggregated work RVU for CPT code 76987, equaling 1.08 (1.62 * \2/3\ =
1.08). Because CPT code 76989 represents one of the three service parts
performed by a cardiologist, we allotted 1/3rd of the aggregated work
RVU for CPT code 76987, equaling 0.54 (1.62 * \1/3\ = 0.54). Because
the Summary of Recommendations was unclear regarding the intensity of
each part of the service as broken out, we invited comments on
additional ways to break down the aggregate work RVU of CPT code 76987
to adequately account for the cardiothoracic surgeon and cardiologist's
time and intensity to perform CPT codes 76988 and 76989, but we believe
that the work RVUs should sum to no more than the aggregate work RVU
for CPT code 76987 based on similarly broken down code families that
represent the more widely used intraoperative TEE procedures.
The RUC did not recommend, and we did not propose any direct PE
inputs for the five codes in the Intraoperative Ultrasound family.
Comment: Some commenters disagreed with CMS' proposed work RVU of
0.91 for CPT code 76998, stating that it is invalid to draw comparisons
between the current work times and work RVUs to the newly surveyed work
time and work RVUs as recommended by the RUC because they were
``Harvard'' times. One commenter disagreed with the use of total time
ratios to account for changes in time and stated that the work RVU was
reduced by CMS for CY 1993 and 1995 without the time being adjusted,
rendering the originally assigned times and work RVUs untethered. The
commenter also stated that the proposed work RVU of 0.91 for CPT code
76998 is only 1/3rd more intense than CPT code 76641, which describes a
diagnostic ultrasound study that is typically performed by a
technician, where the saved images are then reviewed, and an
interpretation report is generated by a radiologist at a later time. In
comparison, a surgeon uses an ultrasound probe periodically during the
operation and interprets the images in real time to help direct the
limits of surgical excision of a mass, images are saved, and a report
is generated by the surgeon for CPT code 76998. The commenter stated
that the intensity and complexity of CPT code 76998 (dynamic real-time
ultrasound at operation) is significantly greater than CPT code 76641.
The commenter also stated that CPT code 76641 represents a single
ultrasound session typically performed by a technician, whereas CPT
code 76998 includes multiple separate ultrasound maneuvers throughout
an operative procedure by the surgeon, which require a more intense
immediate interpretation in order to direct resection of the breast
tissue to ensure a thorough and complete surgical excision of the
abnormal breast tissue.
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
[[Page 78907]]
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 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.
With regards to the relativity of intensity and complexity of CPT
code 76998 (dynamic real-time ultrasound at operation) compared to CPT
code 76641, we continue to believe that the intensity of CPT code 76998
(real-time during an operation) is greater than the identically-timed
CPT code 76641. The work RVU of 0.91 for CPT code 76998 adequately
values the surgeon's 5 minutes of pre-service time, 12 minutes of
intraservice time, and 5 minutes of immediate post-service time more
than the same 5, 12, and 5 minutes for CPT code 76641, which has a work
RVU of 0.73. Additionally, the IWPUT of CPT code 76641 is appropriately
less than the IWPUT of CPT code 76698, with IWPUTs of 0.0422 and
0.0572, respectively.
Comment: Commenters disagreed with the comparison to intraoperative
TEE and stated that the sum of the different components of work will
not be the same as the combined work as it is for intraoperative TEE.
The commenters stated that there would be time savings, as represented
by the surveyed times, if the cardiothoracic surgeon provides the
service alone, represented by CPT code 76987. Commenters also stated
that CPT codes 73219 and 78452 are inappropriate comparator codes, as
they are not intraoperative services and CPT code 78452 describes
cardiac imaging performed on a patient before and after exercise in
which a technologist typically handles the image acquisition.
Commenters stated that CPT code 76987 is rarely performed and describes
ultrasound image acquisition performed in the operating room through an
open chest where the ultrasound probe is placed directly on the
patient's beating heart and sterility must be maintained throughout.
Commenters suggested that a work RVU of 1.90 was supported by
comparison to CPT code 93317, with a work RVU of 1.84, intraservice
time of 20 minutes, and total time of 40 minutes, which is the
component code for the image acquisition, interpretation and report
only of the congenital TEE codes.
Response: We agree with commenters that the proposed work RVU does
not adequately account for the complexity of the intraoperative
ultrasound image acquisition performed on a beating heart with abnormal
heart structure, and that CPT code 93317 is a better comparator code
with a work RVU of 1.84. Therefore, we are finalizing the RUC-
recommended work RVU of 1.90 for CPT code 76987.
Comment: Some commenters disagreed with CMS' proposed work RVU of
1.08 for CPT code 76988. Commenters stated that CPT code 76988
describes ultrasound image acquisition performed in the operating room
through an open chest in a sterile field where the ultrasound probe is
placed directly on the patient's beating heart. Commenters stated that
the cardiologist can provide guidance to the cardiothoracic surgeon to
ensure capture of certain views and that work by the cardiologist is
captured in CPT code 76989. The physician work involved in placing and
manipulating the echo probe both before surgical repair and after
repair with various suture lines requires careful manual manipulation
and positioning by the cardiothoracic surgeon in order to obtain
certain views. The commenters stated that, because of the abnormal
structure of the heart and the surgical repair, the normal external
landmarks for probe positioning are not present adding increased
complexity to the procedure.
Response: We agree with commenters that the proposed work RVU does
not adequately account for the complexity of the intraoperative
ultrasound image acquisition performed on a beating heart with abnormal
heart structure and are finalizing the RUC-recommended work RVU of 1.20
for CPT code 76987.
Comment: Some commenters disagreed that the combination of CPT
codes 76988 and 76989 should equal the value for CPT code 76987, and
stated that this methodology is flawed and inconsistent with how CMS
pays for most services that are performed by multiple providers for
which CMS provides payment that is greater than 100% to the two
surgeons. The commenters stated that when there are co-surgeons
(modifier 62), CMS's payment of 125 percent is split between the two
surgeons. Similarly, when there is an assistant at surgery (modifier
80), CMS pays the primary surgeon 100 percent and the assistant at
surgery 16 percent. Commenters also disagreed with the proposed median
intraservice time of 15 minutes rather than the RUC-recommended 75th
percentile intraservice time, stating that pediatric cardiologists
completing the survey underestimated the amount of time they spent in
the operating room and stated that the nature of the service where the
cardiologist is not in the operating room during the entire procedure
but rather in the operating room prior to the repair(s), leaves and
then comes back at the completion of the repair(s) could have resulted
in the survey respondent's underestimation of time. Therefore, the
commenters stated that the 75th percentile intraservice time of 20
minutes is more appropriate for CPT code 76989.
Response: We continue to believe that, because this family is
broken down into service parts in the same way CPT codes 93312 through
93314 and 93315 through 93317 are, the work RVUs for CPT codes 76988
and 76989 should not sum to more than the aggregate work RVU for CPT
code 76987. We did not receive comments that clarified the intensity of
each part of the service as broken out from the aggregate work RVU of
CPT code 76987 to adequately account for the cardiothoracic surgeon and
cardiologist's time and intensity to perform CPT codes 76988 and 76989.
Commenters only stated that co-surgeons and assistants at surgery are
paid more than 100 percent and commenters reiterated that the RUC
recommended that CPT code 76989 to be valued higher than CPT code
76988. While this is true, these codes along with the intraoperative
TEE codes for congenital cardiac anomalies are not structured to allow
the billing of co-surgeons or assistants at surgery. Rather, the CPT
Editorial Panel structured these codes to have clearly sanctioned,
disaggregated service parts to allow for
[[Page 78908]]
multiple providers to perform different parts of the aggregate service
represented by CPT codes 76987 and 93315.
As stated above, CPT code 93317 represents image acquisition and
interpretation and report only, typically done by the cardiologist
after probe placement typically performed by the cardiac
anesthesiologist, represented by CPT code 93316. Similarly, CPT code
76989 represents interpretation and report only, which is typically
performed by a cardiologist according to the Summary of
Recommendations. We note that the services as described by the
disaggregated component CPT codes 76988 and 76989 would likely be an
assistant at surgery situation if the codes were structured to be
billed this way because CPT code 76989 is described as the cardiologist
assisting the cardiothoracic surgeon on probe placement and
manipulation with real-time image interpretation, guidance, and
discussion of the findings before and after the cardiac repair(s) to
ensure accurate image acquisition and to determine if the repair(s) is
adequate or additional procedures are needed after the cardiac repair
is complete. In this case, where the cardiologist is acting as an
assistant at surgery, the primary surgeon who is actually placing and
manipulating the probe on the beating heart would be paid 100 percent
and the assistant surgeon would be paid 16 percent. If this were the
case, the cardiologist that performs the work described by CPT code
76989 would be valued at 0.30 work RVUs (based on 16 percent of the
finalized work RVU of 1.90 for CPT code 96987). Similarly, CPT code
93315 cannot be billed with modifier 62 or 80, but rather the codes
were structured to allow for multiple providers to perform different
parts of the aggregate service represented by CPT code 93315 by
cardiologists and cardiac anesthesiologists, yet the work RVUs of CPT
codes 93317 and 93316 do not total more than the work RVU of CPT code
93315.
We continue to believe that the sum of the work RVUs for CPT codes
76988 and 76989 should not be more than the aggregate work RVU of CPT
code 76987 and disagree with the RUC that CPT code 76989 should be
valued higher than CPT code 76988 based on the code descriptions and
breakdown of service parts. Therefore, we are finalizing a work RVU of
0.70 for CPT code 76989 based on the subtraction of the finalized work
RVU of 1.20 for CPT code 76988 from finalized work RVU of 1.90 for CPT
code 76987. We subtracted these final work RVUs from each other to
calculate the work RVU for CPT code 76989 to maintain the relationship
where the work RVUs for CPT codes 76988 and 76989 sum to the work RVU
of CPT code 76987. We note that commenters did not respond to the
request for additional information that clarified the intensity of each
part of the service as broken out from the aggregate work RVU of CPT
code 76987 to adequately account for the cardiothoracic surgeon and
cardiologist's time and intensity to perform CPT codes 76988 and 76989.
We note that this final work RVU is greater than the 0.30 work RVUs
that the cardiologist would receive if the surgeons were able to bill
CPT code 76987 with modifier 80, greater than the proposed work RVU of
0.54, and greater than the work RVU of 0.63 that would result if we
maintained the proposed methodology for calculating a work RVU for CPT
code 76989, in which it where it was based on \1/3\ of the work RVU of
CPT code 76987 (1.90 * \1/3\ = 0.63).
With regards to the intraservice time for CPT code 76989, we agree
with the commenters that it is possible that the survey respondents
underestimated their intraservice time because they are in and out of
the operating room throughout the procedure, and that it is typical
that the cardiologist spends 20 minutes of intraservice time for CPT
code 76989 rather than the proposed 15 minutes. Therefore, we are
finalizing the RUC-recommended work times for CPT code 76989 as
follows: 5 minutes of pre-evaluation time, 20 minutes of intraservice
time, and 10 minutes of immediate postservice time for total time of 35
minutes.
After consideration of the public comments, we are finalizing the
proposed work RVUs for CPT codes 76984 and 76998 of 0.60 and 0.91,
respectively, the RUC-recommended work RVUs of 1.90 and 1.20 for CPT
codes 76987 and 76988, respectively, and a work RVU of 0.70 for CPT
code 76989.
(17) Percutaneous Coronary Interventions (CPT Code 92972)
In September 2022, the CPT Editorial Panel created one new Category
I CPT code for percutaneous coronary lithotripsy. Sixteen other
percutaneous coronary intervention (PCI) codes were considered part of
the code family but were ultimately not reviewed by the RUC. New add-on
CPT code 92972 was reviewed by the RUC on an interim basis for CY 2024
while the entire percutaneous coronary intervention code family was
referred to the CPT Editorial Panel for restructuring for the CY 2025
cycle.
We proposed the RUC-recommended work RVU of 2.97 for CPT code 92972
(Percutaneous transluminal coronary lithotripsy). The RUC did not
recommend and we did not propose any direct PE inputs for this
facility-based add-on service.
Comment: Several commenters thanked CMS for our consideration and
for proposing the RUC's recommended work RVU for this code.
Response: We appreciate the support for our proposals from the
commenters.
After consideration of the public comments, we are finalizing the
work RVU and lack of direct PE inputs for CPT code 92972 as proposed.
(18) Auditory Osseointegrated Device Services (CPT Codes 92622 and
92623)
In February 2022, the CPT Editorial Panel created CPT code 92622
(Diagnostic analysis, programming, and verification of an auditory
osseointegrated sound processor, any type; first 60 minutes) and 92623
(Diagnostic analysis, programming, and verification of an auditory
osseointegrated sound processor, any type; each additional 15 minutes
(list separately in addition to code for primary procedure) for CY
2024. CPT code 92623 serves as the add-on code for base CPT code 92622.
We proposed the RUC-recommended work RVU of 1.25 for CPT code 92622
and 0.33 for CPT code 92623. We also proposed the RUC-recommended
direct PE inputs for both codes. Additionally, because audiologists
provide these services, we proposed to add CPT codes 92622 and 92623 to
the list of audiology services that can be billed with the AB modifier,
that is personally provided by audiologists without a physician/NPP
referral for non-acute hearing conditions--the list for CY 2023 is
available at https://www.cms.gov/audiology-services.
Comment: A majority of commenters supported the CMS proposal of the
RUC-recommended values for CPT codes 92622 and 92623, as well as the
proposal to add the AB modifier.
Response: We thank the commenters for their support.
Comment: One commenter disagreed with the valuation of these codes
and stated that the RVU work value of 1.25 for CPT code 92622 is lower
than other, less technical timed audiology codes and as a result will
cause financial problems for audiologists to continue providing these
procedures. This commenter urged CMS to reconsider the valuation of
these codes.
Response: We thank the commenter for their feedback but we continue
to believe that the RUC-recommended
[[Page 78909]]
values for these codes are correct. The RUC's recommended work RVU was
based on a survey of 45 audiologists and supported by two key reference
service codes: CPT codes 92626 (Evaluation of auditory function for
surgically implanted device(s) candidacy or postoperative status of a
surgically implanted device(s); first hour) (work RVU = 1.40, 7 minutes
pre-service, 60 minutes intra-service and 10 minutes post-service
time)) and 92603 (Diagnostic analysis of cochlear implant, age 7 years
or older; with programming) (work RVU = 2.25, 20 minutes pre-service,
82 minutes intra-service and 20 minutes post-service time)). These
codes are optimal comparators as both have similar intensity to the
surveyed code and service period times that increase respectively as
the RVU increases. These reference service codes demonstrate
appropriate relativity within other XXX-global audiologic and hearing
implant testing services.
After consideration of the comments, we are finalizing the work
RVUs and direct PE inputs for CPT codes 92622 and 92623 as proposed.
(19) Venography Services (CPT Codes 93584, 93585, 93586, 93587, and
93588)
In February 2022, the CPT Editorial Panel created six new CPT add-
on codes to describe Venography services that are performed during
cardiac catheterization for congenital heart defects in the superior
vena cava (SVC), the inferior vena cava (IVC), and in other congenital
veins, that will be reported in conjunction with the main cardiac
catheterization procedure codes (CPT codes 93593-93598). CPT codes
93584 (Venography for congenital heart defect(s), including catheter
placement, and radiological supervision and interpretation; anomalous
or persistent superior vena cava when it exists as a second
contralateral superior vena cava, with native drainage to heart (List
separately in addition to code for primary procedure)) and CPT codes
9X001 (Venography for congenital heart defect(s), including catheter
placement, and radiological supervision and interpretation; inferior
vena cava (List separately in addition to code for primary procedure))
were to replace the two more general CPT codes 75827 (Venography,
caval, superior, with serialography, radiological supervision and
interpretation) and 75825 (Venography, caval, inferior, with
serialography, radiological supervision and interpretation). CPT code
9X001 has since been rescinded, and all the remaining new add-on codes
have been clarified to state in their descriptors that they are
specifically for congenital heart defects.
For CPT code 93584 (Venography for congenital heart defect(s),
including catheter placement, and radiological supervision and
interpretation; anomalous or persistent superior vena cava when it
exists as a second contralateral superior vena cava, with native
drainage to heart (List separately in addition to code for primary
procedure)), the AMA RUC proposed a work RVU of 1.20 for 10 minutes of
intra-service time and total time. We proposed the AMA RUC recommended
work RVU of 1.20 with 10 minutes of intra-service time and total time
for CPT code 93584.
For CPT code 93585 (Venography for congenital heart defect(s),
including catheter placement, and radiological supervision and
interpretation; azygos/hemi-azygos venous system (List separately in
addition to code for primary procedure)), the AMA RUC proposed a work
RVU of 1.13 for 10 minutes of intra-service time and total time. We
noted that this code has the same number of minutes as CPT code 93584,
but with a lower recommended work RVU. We proposed the AMA RUC
recommended work RVU of 1.13 with 10 minutes of intra-service time and
total time for CPT code 93585.
For CPT code 93586 (Venography for congenital heart defect(s),
including catheter placement, and radiological supervision and
interpretation; coronary sinus (List separately in addition to code for
primary procedure)) the AMA RUC proposed a work RVU of 1.43 for 12
minutes of intra-service time and total time. We noted that this code
has two additional minutes than CPT code 93584 which is 20 percent more
in physician time than the 10 minutes from CPT code 93584. We proposed
the AMA RUC recommended work RVU of 1.43 with 12 minutes of intra-
service time and total time for CPT code 93586.
For CPT code 93587 (Venography for congenital heart defect(s),
including catheter placement, and radiological supervision and
interpretation; venovenous collaterals originating at or above the
heart (e.g., from innominate vein) (List separately in addition to code
for primary procedure)), the AMA RUC proposed a work RVU of 2.11 for 16
minutes of intra-service time and total time. We noted that this code
has six additional minutes more than CPT code 93584 (10 minutes), which
is 60 percent more physician time. Although we do not imply that
increases in time as reflected in survey values must equate to a one-
to-one or linear increase in the valuation of work RVUs, we believe
that since the two components of work are time and intensity,
significant increases in time within the same code family should
typically be reflected in increases to work RVUs. In the case of CPT
code 93587, we believe that it would be more accurate to propose a work
RVU of 1.92 to account for this increase in the surveyed work time as
compared with CPT code 93584. Therefore, we proposed a work RVU of 1.92
along with 16 minutes of intra-service time and total time for CPT code
93587.
For CPT code 93588 (Venography for congenital heart defect(s),
including catheter placement, and radiological supervision and
interpretation; venovenous collaterals originating below the heart
(e.g., from the inferior vena cava) (List separately in addition to
code for primary procedure)), the AMA RUC proposed a work RVU of 2.13
for 17 minutes of intra-service time and total time. We noted that this
code has seven additional minutes more than CPT code 93584 (10
minutes), which is 70 percent more physician time than CPT code 93584.
Although we do not imply that increases in time as reflected in survey
values must equate to a one-to-one or linear increase in the valuation
of work RVUs, we believe that since the two components of work are time
and intensity, significant increases in time within the same code
family should typically be reflected in increases to work RVUs. In the
case of CPT code 93588, we believe that it would be more accurate to
propose a work RVU of 2.04 to account for this increase in the surveyed
work time as compared with CPT code 993584. Therefore, we proposed a
work RVU of 2.04 along with 17 minutes of intra-service time and total
time for CPT code 93588.
The RUC did not recommend and we did not propose any direct PE
inputs for the five codes in the Venography Services family.
Comment: We received a few comments concerning these five new add-
on codes for Venography congenital heart defect(s). All commenters were
in favor of CMS accepting the AMA RUC recommended work RVUs for CPT
codes 93584, 93585, and 93586. All commenters were also not in favor of
the CMS proposed work RVUs for CPT codes 93587 and 93588, and they
urged CMS to withdraw our proposed values and accept the RUC
recommended values. Additionally, commenters stated that CPT codes
93584, 93585, 93586, 93587 and 93588, which were introduced for review
as a family of congenital heart catheter add-on codes, are actually
more of a selectively unique group of codes that are distinct from one
another, rather than a family of codes in
[[Page 78910]]
the usual sense, and CMS had mistakenly treated them as a usual family
of codes.
Response: We agree with the commenters regarding the grouping of
these congenital heart catheter add-on codes. We acknowledge that these
codes are services that are selectively unique and distinct from one
another, and that they are not a just family of codes that are a series
of similar services, as in having a base code with successively
increasing values of magnitude of similar iterations in a rank order.
As a result, we are finalizing the AMA RUC recommended work RVUs of
2.11 for CPT code 93587, and 2.13 for 93588. We are also finalizing the
AMA RUC recommended work RVUs for CPT codes 93584, 93585, and 93586, as
proposed.
(20) Post Operative Low-Level Laser Therapy (CPT Code 97037)
In May 2022, the CPT Editorial Panel created CPT code 97037
(Application of a modality to 1 or more areas; low-level laser therapy
(i.e., non-thermal and non-ablative), for post operative pain
reduction) to describe the application of low-level laser therapy for
post operative pain reduction. The RUC did not offer a recommendation
on CPT code 97037 and we did not realize that this code would be added
to the CPT code set for CY 2024 until after the publication of the
proposed rule. Although we did not receive recommendations for CPT code
97037 and did not have the opportunity to solicit public comments on
its valuation, we are finalizing non-covered status (Procedure Status
``N'') for CPT code 97037 because NCD 270.6 states: The use of infrared
and/or near-infrared light and/or heat, including monochromatic
infrared energy, is non-covered for the treatment, including the
symptoms such as pain arising from these conditions, of diabetic and/or
non-diabetic peripheral sensory neuropathy, wounds and/or ulcers of the
skin and/or subcutaneous tissues. Thus, it is noncovered by Medicare.
(21) General Behavioral Health Integration Care Management (CPT Code
99484, and HCPCS Code G0323)
We proposed to refine the work RVU of both CPT code 99484 and HCPCS
code G0323, (see section II.J.1.c. of this final rule), by increasing
the work RVU to 0.93 from the current 0.61 and increasing the work time
to 21 minutes to match the results of the surveyed work time. For CPT
code 99484 we proposed the direct PE inputs as recommended by the RUC
without refinement. We also proposed the same PE inputs for HCPCS code
G0323.
CMS created four behavioral health integration (BHI) HCPCS G-codes
for CY 2017. In 2018 the codes were replaced by new CPT codes. At that
time RUC specialty societies undertook a survey, but the RUC did not
use the survey results to establish work RVUs, and instead adopted the
valuations we had finalized in 2017. For CY 2017 we finalized a work
RVU of 0.61 based on a direct crosswalk from CPT code 99490 (chronic
care management services) (81 FR 80351). We recognized that the
services described by CPT code 99490 are distinct from those furnished
under BHI, but we stated that until we have more information about how
the services described by HCPCS code G0507 (replaced in 2018 by CPT
code 99484) are typically furnished, we believed valuation based on an
estimate of the typical resources would be most appropriate (81 FR
80351). For CY 2022 we increased the value of CPT code 99490 from 0.61
to 1.00 (86 FR 65118).
In the CY 2023 PFS final rule (87 FR 69549), we finalized a new
HCPCS code G0323 (care management services for behavioral health
conditions, at least 20 minutes of clinical psychologist or clinical
social worker time, per calendar month. (These services include the
following required elements: Initial assessment or follow-up
monitoring, including the use of applicable validated rating scales;
behavioral health care planning in relation to behavioral/psychiatric
health problems, including revision for patients who are not
progressing or whose status changes; facilitating and coordinating
treatment such as psychotherapy, coordination with and/or referral to
physicians and practitioners who are authorized by Medicare to
prescribe medications and furnish E/M services, counseling and/or
psychiatric consultation; and continuity of care with a designated
member of the care team.)) (See section II.J.1.c. of this final rule,
for final code descriptor refinement.) We valued HCPCS code G0323 based
on a direct crosswalk to the work values and direct PE inputs for CPT
code 99484, because we believed the services described by HCPCS code
G0323 mirrored those described by CPT code 99484. We noted that we may
consider changes in how this code is valued for future rulemaking.
We continue to be concerned about undervaluing care management
services under the PFS given the variability of costs involved with
these evolving models of care. The RUC has recommended revaluing CPT
code 99484, following a survey of 63 respondents. The median survey
work RVU was 1.30, and the median time was 21 minutes (all intra-
service). The specialty societies recommend a value of 0.93 based on a
crosswalk to code 99202. We believe the specialty societies are in a
good position to understand the evolving practice models. The RUC has
recommended the 25th percentile survey work RVU of 0.85. Consistent
with our goals of ensuring continued and consistent access to these
crucial care management services we are finalizing to increase the work
RVU of CPT code 99484 to 0.93. This value reflects the work RVU of CPT
code 99202, which has a similar work time.
We continue to believe that the services described by HCPCS code
G0323 (section II.J.1.c. of this final rule) closely mirror those
described by CPT code 99484. As we proposed to update the work RVU and
one of the PE inputs for CPT code 99484, we continue to believe that a
direct crosswalk to the work values and direct PE inputs for CPT code
99484, is an appropriate valuation of the level, time, and intensity of
the services under HCPCS code G0323 (section II.J.1.c. of this final
rule). As such we proposed to value HCPCS code G0323, (section
II.J.1.c. of this final rule), based on a direct crosswalk to the work
values and direct PE inputs for CPT code 99484, previously in this
section.
We continue to believe that there is a systemic undervaluation of
work estimates for behavioral health services. We proposed values for
CY 2024 that we believe will more accurately value the work involved in
delivering behavioral health services.
Comment: Nearly all commenters were supportive of our proposal to
increase payment for general behavioral health integration services.
Some also expressed their appreciation for our support for multiple
evidence-based models of integrated care, as it allows psychologists
the flexibility required to support the behavioral health needs of the
broader community. Some requested that we increase the payment for CPT
code 99484 and HCPCS code G0323 to, at a minimum, account for the lower
reimbursement rate that nonphysician MH and SUD counselors receive for
delivering these services (75 percent of the Physician Fee Schedule)
and ensure that such providers receive an adequate rate. Other
commenters urged us to ensure the reimbursement rates are adequate,
accounting for the systemic undervaluation of work for behavioral
health services and increase where appropriate.
Response: We thank commenters for their overwhelming support for
our
[[Page 78911]]
proposal. We note that the statute requires that clinical social
workers are paid 75 percent of the amount paid to clinical
psychologists. We also note that we are refining the code descriptor
for HCPCS code G0323 to allow two new provider types to bill HCPCS code
G0323. We refer commenters to section II.J.1.c. of this final rule for
discussion of these two new provider types and to section II.J.5. of
this final rule discussion of steps we are taking to improve the
accuracy of the valuation of behavioral health services. We are
finalizing values for CPT code 99484 and HCPCS code G0323, as proposed.
Comment: Some commenters requested that CMS consider creating a
code for 20 minutes of additional care management services for
behavioral health conditions. One commenter requested that CMS also
increase payment for the three Collaborative Care Model behavioral
health integration codes. Another requested that CMS also increase
payment for Screening, Brief Intervention, and Referral to Treatment
(SBIRT) services (HCPCS codes G0396 and G0397) to encourage greater
integration of SUD treatment in primary care and more widespread
screening for SUDs.
Response: We may consider the development of a code for 20
additional minutes of care management services for behavioral health
conditions in future rulemaking. We note that we have a process for
potentially misvalued codes, whereby we adjust the codes' RVUs taking
into account recommendations provided by interested parties. On an
annual basis prior to developing the proposed rule, we seek nominations
from the public and from interested parties for codes that they believe
we should consider as potentially misvalued. We invite the commenters
to make such nominations per the process outlined in section II.C. of
this final rule.
Comment: One commenter encouraged us to ensure that non-Medicare
eligible Addiction Counselors and peer support specialists be permitted
to participate in furnishing BHI services, consistent with applicable
requirements for auxiliary personnel.
Response: We thank the commenter for raising the contributions that
addiction counselors and peer support specialists might be able to make
in the delivery of general behavioral health integration services as
auxiliary personnel. CPT code 99484 may be billed by a physician or
nonphysician practitioner (NPP), referred to as a qualified health care
professional in the AMA's CPT Editorial Panel CPT[supreg] codebook,
whose State licensure and scope of practice includes evaluation &
management (E/M) services and who is authorized under their Medicare
statutory benefit category to bill Medicare independently for their
services (See FAQs about billing Medicare for BHI services, https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Downloads/Behavioral-Health-Integration-FAQs.pdf).
Medicare Part B pays for services and supplies incident to the service
of a physician (or other practitioner), under Sec. 410.26. This
regulation permits payment for services and supplies furnished by the
physician or other practitioner with an incident to benefit or
auxiliary personnel. Auxiliary personnel must meet any applicable
requirements to provide incident to services, including licensure,
imposed by the State in which the services are being furnished. As
such, a physician or NPP would be able to bill for behavioral health
integration services furnished by addiction counselors and peer support
specialists as auxiliary personnel under their general supervision if
the addiction counselors and peer support specialists meet all the
requirements under Sec. 410.26.
We created HCPCS code G0323 specifically for clinical psychologists
and social workers (section II.J.1.c. of this final rule), whose scope
of practice does not include evaluation & management (E/M) services, to
bill general behavioral health integration services. Only clinical
psychologists have an incident to benefit enabling them to bill for
general behavioral health integration services furnished under their
general supervision by auxiliary personnel.
Comment: One commenter expressed dissatisfaction with the adequacy
of the behavioral health integration codes and on that basis stated
there was no need to increase their payment rates at this time. On the
other hand, the commenter did offer that over time CMS should review
and increase payment for more mental health and substance use services
and integrated care codes to incentivize more providers to participate
in Medicare and support innovation.
Response: We thank the commenter for their perspective and
feedback. As discussed in the proposal we agree with the RUC and
specialty societies that an increase in work RVUs is appropriate at
this time. We are finalizing as proposed the work RVUs for both CPT
code 99484 and HCPCS code G0323, (see section II.J.1.c. of this final
rule), by increasing the work RVU to 0.93 from the current 0.61 and
increasing the work time to 21 minutes to match the results of the
surveyed work time. For CPT code 99484, we are finalizing the direct PE
inputs as recommended by the RUC without refinement. We are also
finalizing the same PE inputs for HCPCS code G0323.
(22) Advance Care Planning (CPT Codes 99497 and 99498)
In January 2022, the Relativity Assessment Workgroup reviewed CPT
codes 99497 and 99498. The Workgroup determined these advance care
planning services should be examined given the recent changes in
evaluation and management services. The RUC recommended that CPT codes
99497 and 99498 be surveyed for physician work and practice expense for
the April 2022 RUC meeting. The RUC recommended no changes in physician
time, work RVUs, or direct PE inputs for these services for CY 2024.
We proposed the RUC-recommended work RVU of 1.50 for CPT code 99497
and 1.40 for CPT code 99498, which are the current values for these
codes. We proposed the RUC-recommended direct PE inputs for these codes
without refinement.
Comment: Some commenters supported our proposal to value these
services with the RUC-recommended work RVUs and direct PE inputs
without refinement.
Response: We appreciate the support of commenters.
Comment: One commenter did not support our proposal and stated that
we should instead finalize work RVUs based on the survey median values,
stating that the fact that CPT code 99498 is valued at an interval
between the 25th and the median work RVU is anomalous and that the
proposed values do not reflect that primary care delivery has become
significantly more complex for providers and patients.
Response: As the commenter noted, the RUC survey material states,
``When CPT code 99498 is reported, it is typically a much more
difficult situation that requires extra time and effort beyond that
required for the base code and usually includes the presence of family
members. This add-on code is more intense than the first 30 minutes of
advance care planning because the physician or qualified health care
professional (QHP) is not just filling out forms but is working through
contentious and difficult issues and educating the family members on
all diagnoses to reach planning decisions.'' We believe this difference
in intensity between the two codes is accurately reflected in the
slightly higher intensity of CPT code 99498 that results from the RUC-
recommended values.
[[Page 78912]]
After considering the comments, we are finalizing the RUC-
recommended work RVUs and direct PE inputs for these codes without
refinement, as proposed.
(23) Pelvic Exam (CPT Code 99459)
In September 2022, the CPT Editorial Panel created a new CPT code
for reporting a pelvic exam--CPT code 99459. The specialty societies
noted that reimbursement for the work would be captured with the
problem-oriented E/M code billed for the visit. The CPT Editorial Panel
agreed, thus the new code is a practice expense only code that captures
the direct practice expenses associated with performing a pelvic exam
in the non-facility setting. CPT code 99459 (Pelvic Exam) captures the
4 minutes of clinical staff time associated with chaperoning a pelvic
exam.
We proposed the RUC-recommended direct-PE inputs for CPT code 99459
without refinement. As a PE-only service, the RUC did not recommend and
we did not propose a work RVU for this code.
Comment: One commenter noted that they believe there was an error
with Addendum B regarding the PE RVUs for CPT code 99459.
Response: We thank the commenter for their support. We do not
believe there is an error in Addendum B for CPT code 99459. The PE RVUs
are listed correctly with 0.68 RVUs for non-facility and ``NA'' for
facility, as there are no direct-PE inputs for this code in the
facility setting.
After consideration of the public comments, we are finalizing our
direct PE inputs for CPT code 99459 as proposed.
(24) Hyperthermic Intraperitoneal Chemotherapy (HIPEC) (CPT Codes 96547
and 96548)
In September 2022, the CPT Editorial Panel created two time-based
add-on Category I CPT codes 96547 (Intraoperative hyperthermic
intraperitoneal chemotherapy (HIPEC) procedure, including separate
incision(s) and closure, when performed; first 60 minutes) and 96548
(Intraoperative hyperthermic intraperitoneal chemotherapy (HIPEC)
procedure, including separate incision(s) and closure, when performed;
each additional 30 minutes). CPT codes 96547 and 96548 were surveyed
for the January 2023 RUC meeting. While reviewing the survey data, it
was noted by specialty societies that the instructions were not
sufficient as the survey data reflected time estimates that exceeded
the time specified in the new time-based code descriptors. The RUC has
stated that the survey results for both CPT codes 96547 and 96548 are
inaccurate and that the codes should be resurveyed for 2025. Therefore,
the RUC recommended contractor pricing for CPT codes 96547 and 96548
and that they be referred to the CPT Editorial Panel for revision.
We proposed to contractor price CPT codes 96547 and 96548 for CY
2024.
Comment: We received comments in support of our proposed contractor
pricing for Hyperthermic Intraperitoneal Chemotherapy (HIPEC).
Response: We thank commenters for their support. After
consideration of the public comments, we are finalizing contractor
pricing for these codes as proposed.
(25) Hyperbaric Oxygen Under Pressure (HCPCS Code G0277)
In 2015, CMS created HCPCS code G0277 (Hyperbaric oxygen under
pressure, full body chamber, per 30 minute interval) to describe direct
practice expense inputs associated with CPT code 99183 (Physician or
other qualified health care professional attendance and supervision of
hyperbaric oxygen therapy, per session) (consistent with the Medicare
Hospital Outpatient Prospective Payment System coding mechanism). At
the September 2022 Relativity Assessment Workgroup meeting, HCPCS code
G0277 was identified as a high-volume growth code with Medicare
utilization of 10,000 or more that have increased by at least 100
percent from 2015 through 2022 and was reviewed at the January 2023 RUC
meeting. Hyperbaric oxygen therapy is typically administered to one
patient in one hyperbaric chamber for 2 hours. Two hours is typical,
and all inputs are prorated for four units being performed (each 30
minutes, totaling 2 hours). All medical supply and time inputs were
divided into quarters.
There was a change in the dominant specialty providing this
service, which is now primarily performed by family medicine. There was
also a change in clinical staff type, and it is now typical for a
single staff person to perform all activities (RN/Respiratory
Therapist) as opposed to two staff (an RN/LPN/MA and an RN/respiratory
therapist). This was primarily due to a 2016 change by the National
Board of Diving and Hyperbaric Medical Technology to no longer allow
certified nursing assistants and certified medical assistants to be
eligible to take the certified hyperbaric technologist examination. The
PE Subcommittee agreed with the specialty societies to update the
clinical staff type to reflect solely L047C RN/Respiratory Therapist.
We agreed with the specialties that the intra-service time is more
appropriately labeled as clinical activity CA021 (Perform procedure/
service--NOT directly related to physician work time) as opposed to
CA018 due to the change in clinical staff type.
We proposed to refine the clinical labor time for the CA013
activity (Prepare room, equipment, and supplies) from 1.5 minutes to
0.5 minutes, as well as the clinical labor time for the CA016 activity
(Prepare, set-up and start IV, initial positioning and monitoring of
patient) from 1 minute to 0.5 minutes to align with the 2-minute
standard for these clinical activities. We arrived at these refinements
by dividing the standard 2-minutes of clinical labor times for CA013
and CA016 by four to account for all inputs being prorated for four
units being performed for one typical 2-hour session. CA013 and CA016
would each be 0.5 minutes per 30-minute interval, which amounts to the
standard 2 minutes for these clinical activities when four units are
billed for the typical 2-hour session. The RUC recommended 30 minutes
for clinical labor activity CA021 (Perform procedure/service--Not
directly related to physician work time (intra-service time) based on a
flawed assumption that the current 15 minutes for CA021 accounts for
two patients receiving treatment simultaneously. We noted that it had
been standard for one patient to receive treatment at a time, and the
current 15 minutes for CA021 was based on a time ratio to the CY 2015
RUC-recommended direct PE inputs for CPT code 99183; therefore, we
disagreed with this RUC recommendation and proposed to refine the
recommended intra-service CA021 clinical labor time to maintain the
current 15 minutes. This was to reflect the 2015 PFS final rule where
``we used the RUC recommended direct PE inputs for CPT code 99183 and
adjusted them to align with the 30-minute treatment interval'' (79 FR
67677). Each PE input was prorated for four units of HCPS code G0277
being provided in one typical 2-hour session. Since CPT code 99183
(Physician or other qualified health care professional attendance and
supervision of hyperbaric oxygen therapy, per session) was a 120-minute
code with 60-minute intra-service time, all PE inputs in HCPCS code
G0277 were prorated for four units being performed.
To conform to these changes in clinical labor time, we also
proposed to refine the equipment time for the EQ362 (HBOT air break
breathing apparatus demand system (hoses, masks, penetrator, and demand
valve)) and
[[Page 78913]]
EQ131 (hyperbaric chamber) equipment items from the recommended 39.75
minutes to 23.25 minutes. This was a result of the 15-minute intra-
service time, as opposed to the RUC recommendation of 30 minutes of
intra-service time.
Comment: We received many public comments disagreeing with the
proposed refinements to the intra-service time (CA021) for HCPCS code
G0277. Many of these comments were based on a concern for patient
safety and supervision. Commenters stated that the standard of practice
for patient safety is attendance and availability of clinical staff for
100 percent of the time. In case of an adverse event that could occur
at any point in treatment, the clinical staff must be present to notify
the physician to alter or stop the treatment. One staff member per
patient must be available to carry out emergency procedures. Commenters
provided many scenarios where an adverse event may require clinical
staff attendance and availability. Due to this standard of practice,
commenters stated that it is necessary for the clinical staff time to
align with the code descriptor (30 minutes). The 30-minute clinical
staff time is required because the patient is at pressure for longer
than the 15-minute proposed time during the treatment. In a standard 2-
hour session, which would account for four units of HCPCS code G0277,
patients are at pressure for 106-110 minutes. Having a clinical staff
time for a total of 60-minutes would not meet the standard of practice
in which the clinical staff is in attendance for the entire treatment.
There were similar comments regarding the equipment times; commenters
specified that the equipment is used the entire treatment time.
Commenters also provided information about the rarity of multiple
patients to receive treatment at the same time, so intra-service time
must be 30 minutes.
Response: We agree with the commenters and are finalizing the RUC-
recommended clinical labor time of 30 minutes for the CA021 clinical
labor task. We acknowledge that this time is needed to meet the
standard of practice for clinical staff supervision during the entire
treatment to ensure patient safety and to align with the time that
patients are at pressure. This will also affect the equipment times
(EQ362 and EQ131), adjusting each to 38.25 minutes to align with the
adjustment to clinical staff time. This is because clinical labor task
CA021 is used in the formula to calculate EQ362 and EQ131, so any
refinements to CA021 also changes those values. We are finalizing RUC
proposed values for CA021, EQ362, and EQ131.
Comment: Many commenters pointed out that clinical staff must be
supervised by a physician the entire time, so clinical staff time
should not be separate from physician work.
Response: The change in designation of intra-service time from
CA018 to CA021 was a RUC recommendation that CMS agreed with. We
specify that clinical staff are supervised by physicians during the
entirety of the treatment. Physician or QHP work is accounted for in
CPT code 99183 (Physician or other qualified health care professional
attendance and supervision of hyperbaric oxygen therapy), while HCPCS
code G0277 solely accounts for practice expenses associated with
hyperbaric oxygen therapy. The change from the CA018 to the CA021
clinical labor task is a clerical update to reflect the fact that HCPCS
code G0277 does not have an intraservice work time by virtue of being a
PE-only code. We are finalizing as proposed to change the intra-service
time from CA018 to CA021, consistent with the RUC recommendations.
Comment: We received many public comments disagreeing with CMS'
proposed refinements to the clinical staff time (CA013 and CA016) which
CMS proposed at 0.5 minutes per 30-minute interval, which amounts for
each of them to equal the standard 2 minutes for these clinical
activities when four units are billed for the typical 2-hour session.
Commenters stated that clinical activities must align with the same
clinical labor values for CPT code 99183 (the code for this service
that is associated with physician work), which exceed the 2-minute
standard. One commenter stated that during this clinical activity time,
clinical staff complete additional activities. Commenters specified
that one reason for clinical activity time to be beyond the standard,
is due to increased need for disinfecting and infection control for the
next patient.
Response: We note that all input values for HCPCS code G0277 do not
align with CPT code 99183, and therefore, clinical activity times do
not need to have the same values. We do not agree that CA013 and CA016
exceed the 2-minute standard for those inputs. We calculated these
times to align with these specific clinical activities (in this case
CA013 and CA016). Each clinical activity has a separate time
calculation; therefore, the 2 minutes total for CA013 only includes
preparing the room, equipment, and supplies. The 2 minutes total for
CA016 only includes preparing, setting up and starting the IV and
initial positioning and monitoring of patient. We do not consider staff
completing additional activities during these specified times . We note
that we did not adjust any of the time requirements that involve post-
service time, for example cleaning rooms and equipment. The refinements
to CA013 and CA016 that we are finalizingdo not affect the time spent
ensuring infection control. We would also like to note that CA013 and
CA016 are not the only aspects of pre-service for the treatment, they
are the only ones that had refinements in this rulemaking cycle. All
other values for pre-service time are aligned with the RUC
recommendations. We disagree with commenters and are finalizing the
proposed time refinements for CA013 and CA016 to align with the
standard 2 minutes for these clinical activities.
After consideration of the public comments, we are finalizing the
proposed CA013 and CA016 direct PE inputs for HCPCS code G0277 and we
are finalizing the RUC-recommended clinical labor time of 30 minutes
for CA021 and equipment times (EQ362 and EQ131) of 38.25 minutes, as
detailed above.
(26) Remote Interrogation Device Evaluation--Cardiovascular (HCPCS Code
G2066, and CPT Codes 93297, and 93298)
CPT code 93299 (Interrogation device evaluation(s), (remote) up to
30 days; implantable cardiovascular physiologic monitor system or
subcutaneous cardiac rhythm monitor system, remote data
acquisitions(s), receipt of transmissions and technician review,
technical support and distribution of results) was meant to serve as a
catch-all for both base CPT codes 93297 and 93298, which are work-only
codes. However, the CPT Editorial Panel determined that CPT code 93299
was no longer necessary if CPT codes 93297 and 93298 were assigned
direct PE inputs and therefore recommended CMS to delete CPT code 93299
at the beginning of CY 2020 under the assumption that CPT codes 93297
and 93298 would be assigned direct PE inputs. Since CMS did not agree
with the recommended values, CMS decided to not allocate direct PE
inputs for CPT codes 93297 or 93298 and instead created contractor
priced HCPCS code G2066 for CY 2020 to ensure these services could
still be furnished that were previously described under CPT code 93299
(84 FR 62777 and 62778). Since the publication of the CY 2020 PFS final
rule, HCPCS code G2066 has remained contractor priced and CPT codes
93297 and 93298 remain as work-only codes. CMS continues to work with
MACs and
[[Page 78914]]
interested parties to address a lot of the payment concerns surrounding
G2066 such as discrepancies in payment between jurisdictions. However,
interested parties have indicated that a long-term solution is needed
from CMS in order to help establish payment stability for these
services.
Therefore, for CY 2024, we proposed to delete HCPCS code G2066 and
proposed the RUC-recommended direct PE inputs for CPT codes 93297 and
93298. Since CPT code 93298 is most commonly billed with G2066, the RUC
recommended the same inputs for CPT code 93298 and HCPCS code G2066 in
the event that no change would be made for HCPCS code G2066. Since CMS
does agree with the RUC recommended values, we proposed to delete HCPCS
code G2066 altogether and establish direct PE-inputs for CPT codes
93297 and 93298 based on the RUC recommendations.
The RUC did not make recommendations on, and we did not propose any
changes to the work RVUs for CPT codes 93297 and 93298.
Comment: One commenter disagreed with the proposal to delete HCPCS
code G2066 and establish direct PE inputs for CPT Codes 93297 and 93298
because they believed CMS did not establish an alternative billing
mechanism to allow continued access to these services in the facility
setting.
Response: We disagree with the commenter that access to these
services will be altered with the coding change. We note that the
services which were previously billed under HCPCS code G2066 will now
be billed under CPT codes 93297 and 93298. This will only change how
the services will be reported but access to these services will remain
the same.
Comment: Several commenters disagreed with the CMS proposal of the
RUC's recommended equipment times for the pacemaker follow-up system
(incl software and hardware) (Paceart) (EQ198) for CPT codes 93297 and
93298. The commenters stated that the RUC's PE subcommittee decided
that the EQ198 equipment is not used when the technician is educating
or re-educating the patient and accordingly reduced the total equipment
minutes per service assigned to the equipment system. The commenters
stated that this is an inaccurate assumption as the equipment must be
operational and accessible for the technician to train the patient on
how to use and understand the monitor, to review clinical status with
the patient, to verify connection status and to further educate the
patient about how to initiate transmissions when needed. The commenters
recommended that CMS update the equipment time assigned to CPT codes
93297 and 93298 to reflect the total clinical labor time assigned to
these services, 33 and 69 minutes, respectively.
Response: We disagree with the commenters and continue to agree
with the RUC's recommendation that the EQ198 equipment would not
typically be in use when the technician is educating or re-educating
the patient. We agree with the commenters that the equipment time would
be needed for tasks such as initiating transmissions with the patient
and verifying their connection status. However, this equipment time is
already incorporated into CPT codes 93297 and 93298 under the 4 minutes
allocated for troubleshooting activities, and as a result we continue
to believe that EQ198 would not typically require additional equipment
time above what the RUC recommended.
Comment: The same commenters stated that if CMS continued to apply
fewer minutes of EQ198 equipment time than the total clinical labor
time for CPT codes 93297 and 93298, then CMS needed to correct a
clerical error in the time assigned to the equipment. The commenters
stated that the RUC's recommendations included 4 minutes of clinical
labor time for education/re-education tasks, however the equipment time
assigned to these services was inadvertently reduced by 11 minutes, in
what appeared to be a clerical error. The commenters stated that if CMS
would not set the EQ198 equipment time equal to the total clinical
labor time assigned to these services, then CMS must correct the
equipment time to only remove the 4 minutes assigned to education/re-
education and finalize 29 minutes of equipment time for CPT code 93297
and 65 minutes of equipment time for CPT code 93298.
Response: After reviewing this information from the commenters,
along with the RUC's recommendations for CPT codes 93297 and 93298, we
agree that there appears to be a clerical error in the equipment
minutes for EQ198. The RUC provided a sum of clinical labor tasks in
its recommendations listing 33 total minutes for CPT code 93297 and 69
total minutes for CPT code 93298. The RUC stated that it was
recommending a removal of the 4 minutes of clinical labor time allotted
for education/re-education tasks from the EQ198 equipment time, but
instead recommended 22 minutes and 58 minutes respectively for the two
codes, a decrease of 11 minutes instead of 4 minutes. This was mostly
likely an inadvertent error since one of the other clinical labor tasks
(Technician requested transmissions) was listed at 11 minutes. We are
therefore finalizing an increase in the EQ198 equipment time, for both
codes, to 29 minutes for CPT code 93297 and to 65 minutes for CPT code
93298. These refinements should correct the errors and align with what
the RUC presumably intended to recommend.
After consideration of the public comments, we are finalizing our
proposal to delete contractor priced code HCPCS code G2066 and
establish direct PE inputs for CPT codes 93297 and 93298.
(27) Payment for Caregiver Training Services
a. Background
In CY 2022, we received AMA RUC recommendations for a new code
family of two codes (CPT code 96202 (Multiple-family group behavior
management/modification training for parent(s)/guardian(s)/caregiver(s)
of patients with a mental or physical health diagnosis, administered by
physician or other qualified health care professional (without the
patient present), face-to-face with multiple sets of parent(s)/
guardian(s)/caregiver(s); initial 60 minutes) and CPT code 96203
(Multiple-family group behavior management/modification training for
parent(s)/guardian(s)/caregiver(s) of patients with a mental or
physical health diagnosis, administered by physician or other qualified
health care professional (without the patient present), face-to-face
with multiple sets of parent(s)/guardian(s)/caregiver(s); each
additional 15 minutes (List separately in addition to code for primary
service)) that described group caregiver training services for patient
behavior management/modification (without the patient in attendance).
In CY 2023 we received AMA RUC recommendations for a family of three
new caregiver training codes (CPT 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), and add-on code,
CPT code 97551 (each additional 15 minutes (List separately in addition
to code for primary service) (Use 97551 in conjunction with 97550)),
and 97552 (Group caregiver training in strategies and techniques to
facilitate the patient's functional performance in the home or
[[Page 78915]]
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). Historically, we have taken
the position that codes describing services furnished to other
individuals without the patient's presence are not covered services. As
we noted in the CY 2023 PFS final rule (87 FR 69521), we have explained
in previous rulemaking that we read section 1862(a)(1)(A) of the Act to
limit Medicare coverage and payment to items and services that are
reasonable and necessary for the diagnosis and treatment of an
individual Medicare patient's illness or injury or that improve the
functioning of an individual Medicare patient's malformed body member.
For example, in the CY 2013 PFS final rule (77 FR 68979), when
discussing payment for the non-face-to-face care management services
that are part of E/M services, we stated that Medicare does not pay for
services furnished to parties other than the patient. We listed, as an
example, communication with caregivers. Because the codes for caregiver
behavior management training described services furnished exclusively
to caregivers rather than to the individual Medicare patient, we
indicated that we did not review the RUC-recommended valuation of these
codes or propose to establish RVUs for these codes for purposes of PFS
payment. Although we did not establish payment for the new caregiver
behavior management training codes in the CY 2023 PFS final rule, we
indicated that there could be circumstances where separate payment for
such services may be appropriate. We stated that we would continue to
consider the status of these and similar services in rulemaking for CY
2024 (87 FR 69522 through 69523). We specifically requested public
comment on how a patient may benefit in medical circumstances when a
caregiver is trained to effectively modify the patient's behavior, how
current Medicare policies regarding these caregiver training services
(CTS) can impact a patient's health, and how the services described by
these codes might currently be bundled into existing Medicare-covered
services. (87 FR 69521). Public comments were generally in favor of CMS
making payment for these codes, stating that there is extensive
empirical support for training parents/guardians/caregivers in behavior
management/modification as a component of the standard of care for the
treatment of certain social determinants of health (SDOH) behavior
issues and that this training promotes improved outcomes. Commenters
also noted that there are several CPT codes paid under the PFS that
describe services that do not include direct contact with the patient
but are still considered integral to the patient's care, including, for
example, separately billable care management services,
interprofessional consultations, and caregiver-focused health risk
assessment instrument (eg, depression inventory) for the benefit of the
patient. In response to public comments, we acknowledged the important
role caregivers could have in a patient's overall care.
As indicated in the CY 2023 PFS final rule, we have continued to
consider whether the caregiver behavior management training and similar
caregiver training services could be considered to fall within the
scope of services that are reasonable and necessary under section
1862(a)(1)(A) of the Act, in alignment with the principles of the
recent Executive Order on Increasing Access to High-Quality Care and
Supporting Caregivers (https://www.whitehouse.gov/briefing-room/presidential-actions/2023/04/18/executive-order-on-increasing-access-to-high-quality-care-and-supporting-caregivers/), and as part of a HHS
level review of our payment policies to identify opportunities to
better account for patient-centered care (https://acl.gov/programs/support-caregivers/raise-family-caregiving-advisory-council), changes
in medical practice that have led to more care coordination and team-
based care, and to promote equitable access to reasonable and necessary
medical services. We also believed it was important for practitioners
furnishing patient-centered care to use various effective communication
techniques when providing patient-centered care, in alignment with
requirements under section 1557 of the Affordable Care Act. We stated
that we believe that, in certain circumstances, caregivers can play a
key role in developing and carrying out the treatment plan or, as
applicable to physical, occupational, or speech-language therapy, the
therapy plan of care (collectively referred to in this discussion as
the ``treatment plan'') established for the patient by the treating
practitioner (which for purposes of this discussion could include a
physician; NPP such as a nurse practitioner, physician assistant,
clinical nurse specialist, clinical psychologist; or a physical
therapist, occupational therapist, or speech-language pathologist). In
this context, we believed Caregiver Training Services (CTS) could be
reasonable and necessary to treat the patient's illness or injury as
required under section 1862 (a)(1)(A) of the Act. We had the
opportunity to consider the best approach to establishing separate
payment for the services described by the caregiver training codes,
especially as it relates to a practitioner treating a patient and
expending resources to train a caregiver who is assisting or acting as
a proxy for the patient.
For CY 2024, we proposed to establish an active payment status for
CPT codes 96202 and 96203 (caregiver behavior management/modification
training services) and CPT codes 97550, 97551, and 97552 (caregiver
training services under a therapy plan of care established by a PT, OT,
SLP). These codes allow treating practitioners to report the training
furnished to a caregiver, in tandem with the diagnostic and treatment
services furnished directly to the patient, in strategies and specific
activities to assist the patient to carry out the treatment plan. We
believed that CTS may be reasonable and necessary when they are
integral to a patient's overall treatment and furnished after the
treatment plan (or therapy plan of care) is established. The CTS
themselves need to be congruent with the treatment plan and designed to
effectuate the desired patient outcomes. We believe this is especially
the case in medical treatment scenarios where assistance by the
caregiver receiving the CTS is necessary to ensure a successful
treatment outcome for the patient--for example, when the patient cannot
follow through with the treatment plan for themselves.
We solicited public comment on this definition of 'caregiver' for
purposes of CTS and were interested if there were any additional
elements of a caregiver that we considered incorporating in the
proposed CTS caregiver definition. We believed that our definition
would allow for holistic patient care with those who know and
understand the patient, their condition, and their environment. We were
interested in and solicited comment on how the clinician and caregiver
interactions would typically occur, including when the practitioner is
dealing with multiple caregivers and how often these services would be
billed, considering the established treatment plan involving caregivers
for the typical patient.
We proposed that payment may be made for CTS when the treating
practitioner identified a need to involve and train one or more
caregivers to assist the patient in carrying out a patient-centered
treatment plan. We further proposed that because CTS are furnished
outside the patient's presence,
[[Page 78916]]
the treating practitioner must obtain the patient's (or
representative's) consent for the caregiver to receive the CTS. We
further proposed 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. In the
following discussion, we detail the specific aspects of our proposal
and the comments received.
Comment: Most commenters supported the proposals. Many commenters
detailed their experiences as caregivers, while others explained how
CTS would have benefited them in the past. Some commenters also
expressed support for CMS' recognition of the efforts of caregivers in
effectuating the treatment of beneficiaries.
Response: We thank commenters for their feedback and value
commenters sharing their experiences on how Caregiver Training Services
could be beneficial.
Comment: Some commenters opposed our CTS proposals and stated that
the proposed services are currently provided by organizations better
equipped to provide CTS, such as home health agencies, home and
community-based services, and non-profit organizations. Some commenters
expressed concern about the efficacy of the services if the patient is
not required to be present, while another commenter stated that there
was insufficient scientific evidence proving that caregiver training
improves patient outcomes. Additionally, one commenter was worried that
CTS would cause medical care to be provided by caregivers as opposed to
medical providers. Overall, many commenters who opposed CTS suggested
direct payment be made to caregivers.
Response: The CTS codes, developed through the AMA CPT Editorial
Panel's process, describe training services furnished by a practitioner
to effectuate the practitioner's treatment plan to improve treatment
outcomes for a patient. We believe there are circumstances where
involving the caregiver in the treating practitioner's treatment plan
through CTS would improve outcomes for the patient. We also believe
that the treating practitioner who develops the treatment plan is best
situated to provide CTS to inform the caregiver on how to help
effectuate the treatment plan they develop for the patient. The
availability of these codes and the provision of these services should
not prevent caregivers from seeking support, education, certifications,
or assistance from other organizations. As with other established
coding, we expect that the treating practitioner who furnishes and
bills for CTS to furnish services as described by the codes.
Additionally, we note that the codes specify that the patient is not
present during the service. We believe this is in recognition that both
the practitioner's and the caregiver's undivided attention should be
focused on the training that is being furnished to help the caregiver
carry out an established treatment plan. In response to comments about
the effects on patient eligibility to receive care under other programs
or by medical providers, we clarify that the provision of CTS to a
patient's caregiver does not affect patient eligibility for other
Medicare services when reasonable and necessary. We clarify for
commenters that under the statute, Medicare makes payments under the
PFS only to enrolled physicians and other practitioners, not to
caregivers. We continue to believe that CTS services have their place
in a reasonable and necessary treatment plan for some patients and can
serve as an important supplement to other caregiver training and other
resources that might be available.
Comment: The majority of commenters supported our proposal to
require the patient's (or representative's) consent for the caregiver
to receive CTS. One commenter stated that the patient's consent for the
initial plan of care is sufficient, so further consent is not needed
for CTS. One commenter suggested using the terms ``informed consent''
or ``supported decision making'' instead of consent. Another commenter
requested that in cases of an Alzheimer's or dementia diagnosis,
patient consent be obtained early in diagnosis. A few commenters
expressed that they did not want CTS to be required for the caregiver
to participate in. One commenter was concerned about patient privacy if
beneficiary consent was not required.
Response: We proposed to specifically require the patient's (or
their representative's) consent for CTS because, unlike most services,
the patient would not be present for the service. We believed it would
be important to make the patient aware, out of concern for patient
privacy, that the service is furnished outside their presence and that
any applicable cost-sharing would be their responsibility. We do not
believe that the general consent to receive treatment would be
sufficient to make a patient aware of the unique circumstances under
which CTS are furnished. For these same reasons, we continue to believe
it is appropriate to require a specific consent for CTS. We are using
the term ``consent'' as opposed to other recommended terms to remain
consistent across other codes with consent requirements across the PFS.
In cases of an Alzheimer's or dementia diagnosis, we encourage
providers to obtain consent from the patient or their representative
for CTS as early as possible in the diagnosis. We want to emphasize
that CTS are not required services but services that the treating
practitioner may choose to furnish, with a patient's consent, in
consideration of a patient's diagnosis. If caregivers do not want to
participate in caregiver training, they are not required to do so. We
are finalizing, as proposed, that the patient's (or representative's)
consent is required for the caregiver to receive CTS and that the
consent must be documented in the patient's medical record.
Comment: Commenters requested more guidance regarding CTS,
including specifically asking for descriptions of training sessions,
the requirement of post-training resources, materials, or referrals to
social agencies to be provided to caregivers, and for CTS to be
culturally competent (including being provided in languages other than
English and at varying literacy levels). Commenters also requested
caregiver assessments to assess burden, capacity, and understanding.
Commenters also suggested that CMS require quality standards for CTS
and suggested teaching methods. Additionally, one commenter requested
that documentation of the caregiver's contact information be required
in the patient's health record. Many commenters also provided input
about the settings in which CTS are provided, suggesting that CTS could
be furnished inside the beneficiary's home, or current residence.
Commenters requested that CTS be provided upon discharge from
hospitals, skilled nursing facilities, or home health outpatient
services. One commenter requested that CTS be included in the
definition of primary care services for purposes of beneficiary
assignment in the Medicare Shared Savings Program.
Commenters also requested additional coding to describe CTS
furnished, for example, when the patient is present for part of all of
the training, to recognize reduced time thresholds, to allow auxiliary
personnel to perform CTS, or when training is included for additional
tasks. Commenters also requested that CTS be added to the Medicare
telehealth services list.
Response: We appreciate all the information and considerations
included in these comments, which will inform any policy development
for CTS
[[Page 78917]]
in future rulemaking. We will not be adding these codes to the
telehealth list at this time. Additionally, concerns not addressed in
this proposed rule, such as quality standards, teaching methods, and
additional requirements may be considered for future rulemaking.
In the CY 2024 PFS proposed rule, we proposed a definition of
``caregiver'' for purposes of CTS and discussed the circumstances under
which patients may benefit from care involving caregivers. We proposed
that CTS may meet the conditions for Medicare payment when the treating
practitioner identifies a need to involve and train caregivers to
assist the patient in carrying out a treatment plan established by the
treating practitioner. We also proposed values for each of the CTS
codes.
(1) Definition of a Caregiver
In the CY 2024 PFS proposed rule, we proposed to define
``caregiver'' for purposes of CTS. We stated that in our ongoing
education and outreach work on the use of caregivers in assisting
patients, we have broadly defined a caregiver as a family member,
friend, or neighbor who provides unpaid assistance to a person with a
chronic illness or disabling condition (https://www.cms.gov/outreach-
and-education/outreach/partnerships/
caregiver#:~:text=Caregivers%20are%20broadly%20defined%20as,chronic%20il
lness%20or%20disabling%20condition). Further, in the context of our
proposals for CTS, we believe a caregiver is an individual who is
assisting or acting as a proxy for a patient with an illness or
condition of short or long-term duration (not necessarily chronic or
disabling); involved on an episodic, daily, or occasional basis in
managing a patient's complex health care and assistive technology
activities at home; and helping to navigate the patient's transitions
between care settings. For purposes of CTS, we also include a guardian
in this definition when warranted. For CTS, when we note ``caregiver,''
we are also referring to guardians who for purposes of CTS, are the
caregiver for minor children or other individuals who are not legally
independent. In these circumstances, a caregiver is a layperson
assisting the patient in carrying out a treatment plan that was
established for the patient by the treating physician or practitioner
and assisted the patient with aspects of their care, including
interventions or other activities directly related to a treatment plan
established for the patient to address a diagnosed illness or injury.
In this context, caregivers would be trained by the treating
practitioner in strategies and specific activities that improve
symptoms, functioning, and adherence to treatment related to the
patient's primary clinical diagnoses. Caregiver understanding and
competence in assisting and implementing these interventions and
activities from the treating practitioner is critical for patients with
functional limitations resulting from various conditions.
The following is a summary of the comments we received and our
responses.
Comment: Many commenters did not favor the proposal to define
caregiver for purposes of CTS to include only unpaid individuals,
stating that this would unfairly exclude nursing aides, direct service
professionals, or individuals paid directly by the beneficiary.
An overwhelming number of commenters requested that CMS use the
definition of ``family caregiver'' that was used in the Recognize,
Assist, Include, Support, and Engage (RAISE) Family Caregivers Act
(Pub. L. 115-119). The definition of family caregiver in the RAISE Act
is ``an adult family member or other individual who has a significant
relationship with, and who provides a broad range of assistance to, an
individual with a chronic or other health condition, disability, or
functional limitation.'' The RAISE Family Caregivers Act directs the
Secretary of Health and Human Services to develop a national caregiving
strategy to recognize and support family caregivers. Commenters
requested the RAISE definition because it is more expansive and
provides more detail about what a caregiver is than the CMS definition.
Commenters also requested that we remove the terms ``layperson,''
``proxy'', and/or ``guardian'' from our definition. One commenter
requested that we use the term ``care partner'' as opposed to
``caregiver.'' Additionally, we note that commenters generally
supported our proposal that CTS could be furnished to more than one
caregiver representing the same beneficiary, as someone could have
multiple caregivers, or the primary caregiver could change.
Response: We agree that the definition of caregiver matters. For
that reason, we agree with commenters that the definition of ``family
caregiver'' used in the RAISE Family Caregivers Act does support our
CTS proposal as an adult family member or other individual who has a
significant relationship with, and who provides a broad range of
assistance to, an individual with a chronic or other health condition,
disability, or functional limitation. We will use the RAISE definition
and the CMS Outreach and Education definition (a family member, friend,
or neighbor who provides unpaid assistance to a person with a chronic
illness or disabling condition). Since the definitions do not
contradict each other, we will adopt both definitions of caregiver.
We note that even as we refine our definition of caregiver, we
maintain that the caregiver population receiving these services on
behalf of the patient should not also receive concurrent CTS under
another Medicare benefit category or Federal program (88 FR 52323).
After considering the public comments, we are finalizing a revised
definition of caregiver to be ``an adult family member or other
individual who has a significant relationship with, and who provides a
broad range of assistance to, an individual with a chronic or other
health condition, disability, or functional limitation'' and ``a family
member, friend, or neighbor who provides unpaid assistance to a person
with a chronic illness or disabling condition''.
(2) Patients Who Benefit From Care Involving Caregivers
In the proposed rule, we discussed our expectation that a patient-
centered treatment plan should appropriately account for clinical
circumstances where the treating practitioner believes a caregiver's
involvement is necessary to ensure a successful outcome for the patient
and where, as appropriate, the patient agrees to caregiver involvement.
There may be clinical circumstances when it might be appropriate for
the physician or practitioner to directly involve the caregiver in
developing and carrying out a treatment plan. Such clinical cases could
include various physical and behavioral health conditions and
circumstances under which CTS may be reasonable and necessary to train
a caregiver who assists in carrying out a treatment plan. Conditions
include, but are not limited to, stroke, traumatic brain injury (TBI),
various forms of dementia, autism spectrum disorders, individuals with
other intellectual or cognitive disabilities, physical mobility
limitations, or necessary use of assisted devices or mobility aids. The
previously mentioned clinical scenarios are circumstances under which
CTS may be reasonable and necessary to train a caregiver who assists in
carrying out a treatment plan. For example, patients with dementia,
autism spectrum disorder, or individuals with other intellectual or
cognitive disabilities may
[[Page 78918]]
require assistance with challenging behaviors to carry out a treatment
plan, patients with mobility issues may need help with safe transfers
in the home to avoid post-operative complications, patients with
persistent delirium may require guidance with medication management,
patients with certain degenerative conditions or those recovering from
stroke may need assistance with feeding or swallowing. Separate from
medical circumstances noted previously, we also seek to avoid
potentially duplicative payment. We would not expect the caregiver
population receiving these services on behalf of the patient to also
receive CTS on behalf of the patient under another Medicare benefit
category or Federal program. Also, we note that when Medicare and
Medicaid cover the same services for patients eligible for both
programs, Medicare generally is the primary payer in accordance with
section 1902(a)(25) of the Act. Based on the specificity of the coding
for our proposal, we do not expect that CTS will neatly overlap with
any other coverage for patients who are dually eligible for Medicare
and Medicaid. However, we solicited public comment regarding whether
States typically cover services similar to CTS under their Medicaid
programs, and whether such coverage would be duplicative of the CTS
codes. We solicited comment on this issue and whether payment is
currently available for CTS through other Federal or other programs.
The following is a summary of the comments we received and our
responses.
Comment: Many commenters suggested various physical and behavioral
health conditions and circumstances under which CTS may be reasonable
and necessary to train a caregiver who assists in carrying out a
treatment plan. The examples provided include traumatic injury, use of
mobility devices, cell therapy, stem cell transplants, cancer, ESRD,
lymphedema, rare diseases, and/or chronic conditions.
Additionally, many commenters detailed how these services could
overlap with State-funded Medicaid consumer-directed programs and
sometimes with our Innovation Center model tests. These commenters also
noted that due to variations in Medicaid and other State programs,
overlap in payment may be difficult to identify.
Response: The examples we provided in the proposed rule of physical
and behavioral health conditions for which CTS might be appropriate
were not intended to be exhaustive. We acknowledge that there are many
circumstances under which CTS may be reasonable and necessary to train
a caregiver who assists in carrying out a treatment plan. Also, we do
not believe participation in Medicaid consumer-directed programs for
dually eligible beneficiaries, or our demonstration models would be
duplicative of the CTS codes, given how the services are designed and
how the consumer-directed programs work. Through the CTS codes,
Medicare will pay the treating practitioner to train caregivers.
Currently, this is not duplicative of the Medicaid consumer- directed
programs due to the limited scope of the CTS. Further, when designing
Innovation Center models, we include overlap policies, billing
policies, and other model parameters that are specifically designed to
avoid duplication.
(3) Reasonable and Necessary CTS
In the CY 2024 PFS proposed rule, we proposed that CTS could be
reasonable and necessary when furnished based on an established
individualized, patient-centered treatment plan or therapy plan of care
accounting for the patient's specific medical needs.
As provided in the code descriptors, treating practitioners may
train caregivers in a group setting with other caregivers involved in
care for patients with similar needs for assistance to carry out a
treatment plan. Training for all the caregivers for the patient could
occur simultaneously, and the applicable CTS codes (CPT code 96202,
96203, and 97552) would be billed once per beneficiary. We solicited
comment on this issue. We also inquired about whether payment is
currently available for CTS through other Federal or other programs. We
considered whether CTS would be reasonable and necessary when furnished
to caregivers in more than one single session, or to (presumably the
same) caregivers by the same practitioner for the same patient more
than once per year and solicited comment on this. We want to note that
the treating physician or NPP may provide training to more than one
caregiver for a single patient.
The following is a summary of the comments we received and our
responses.
Comment: The majority of commenters stated that CTS would be
reasonable and necessary, when furnished to (presumably the same)
caregivers (by the same practitioner for the same patient) in more than
one single session, more than once per year. Many commenters requested
that payment be made per caregiver, not per beneficiary. A few
commenters requested that CTS be limited to practitioners who have a
longitudinal relationship with the patient.
Response: We agree that the number of CTS sessions furnished to
caregivers, by the same practitioner and for the same patient, may be
based on the treatment plan, as well as changes in patient condition,
the treatment plan, the patient's diagnosis, or the patient's
caregivers. In other words, the medical necessity of CTS for the
patient should determine the volume and frequency of the training. CTS
could be considered reasonable and necessary when the treating
practitioner determines a caregiver needs more training to ensure a
successful patient treatment plan outcome. We require the treating
practitioner to document the need for each occurrence of CTS in the
medical record.
To bill for CTS, practitioners should select the appropriate group
code (CPT code 96202, 96203, or 97552) if more than one caregiver is
trained at the same time, or individual code (CPT code 97550, 97551) if
one individual caregiver is trained. If caregivers are trained in a
group, practitioners would not bill individually for each caregiver.
More than one caregiver trained at the same time must be billed under
the group code, as the treating practitioner's time and effort should
not be counted multiple times.
After consideration of the public comments, for CY 2024, we are
finalizing our proposal for CTS with the following clarifications: the
volume and frequency of CTS sessions furnished to caregivers by the
treating practitioner for the same patient may be based on the
treatment plan, as well as changes in patient condition, the treatment
plan, the patient's diagnosis, or the patient's caregivers.
(4) Service Coding and Valuation
Behavior management/modification training for guardians/caregivers
of patients with a mental or physical health diagnosis (CPT Codes 96202
and 96203)
a. Coding
CPT code 96202 (Multiple-family group behavior management/
modification training for parent(s)/guardian(s)/caregiver(s) of
patients with a mental or physical health diagnosis, administered by
physician or other qualified health care professional (without the
patient present), face-to-face with multiple sets of parent(s)/
guardian(s)/caregiver(s); initial 60 minutes) and its add-on code, CPT
code 96203 (Multiple-family group behavior management/modification
training for parent(s)/guardian(s)/caregiver(s) of
[[Page 78919]]
patients with a mental or physical health diagnosis, administered by
physician or other qualified health care professional (without the
patient present), face-to-face with multiple sets of parent(s)/
guardian(s)/caregiver(s); each additional 15 minutes (List separately
in addition to code for primary service)), were two new codes created
by the CPT Editorial Panel during its February 2021 meeting. The two
codes are to be used to report the total duration of face-to-face time
spent by the physician or other qualified health professional providing
group behavior management/modification training to guardians or
caregivers of patients. Although the patient does not attend the group
trainings, the goals and outcomes of the sessions focus on
interventions aimed at effectuating the practitioner's treatment plan
through addressing challenging behaviors and other behaviors that may
pose a risk to the person, and/or others. According to the Summary of
Recommendations (which was submitted by the AMA RUC with the valuation
of this code), during the face-to-face service time, caregivers are
taught how to structure the patient's environment to support and
reinforce desired patient behaviors, to reduce the negative impacts of
the patient's diagnosis on patient's daily life, and to develop highly
structured technical skills to manage the patient's challenging
behavior.
Behavior management/modification training for guardians/caregivers
of patients with a mental or physical health diagnosis should be
directly relevant to the person-centered treatment plan for the patient
in order for the services to be considered reasonable and necessary
under the Medicare program. Each behavior should be clearly identified
and documented in the treatment plan, and the caregiver should be
trained in positive behavior management strategies.
b. Valuation
The RUC recommended the survey median work value for both CPT codes
96202 and 96203. Three specialty societies sent surveys to a random
sample of a subset of their members. Based on survey results and after
discussion, the RUC recommended a work RVU of 0.43 for a specific
patient who was represented in the group session being billed for CPT
code 96202. The RUC noted that this recommendation was based upon a
median group size of six caregivers and includes 10 minutes pre-time,
60 minutes intra-time, and 20 minutes post-time for a total time of 90
minutes. For CPT code 96203, the 15-minute add on code, the RUC
recommended a work RVU of 0.12, which was also based upon a median
group size of six. We proposed the RUC-recommended work RVU of 0.43 for
CPT code 96202 and the RUC-recommended work RVU of 0.12 for CPT code
96203. We also proposed the RUC-recommended direct PE inputs for these
codes. We proposed requiring the full 60 minutes of time to be
performed to report CPT code 96202. The add on code, CPT code 96203,
may be reported once 75 minutes of total time is performed.
Finally, we note that the RUC recommendation included information
suggesting that the RUC intends to review the valuation of these
services again soon.
Comment: Commenters were generally supportive of the proposed
valuations for these codes. A few commenters suggested that higher
valuations would more accurately reflect the time and intensity of
services provided. These commenters expressed concerns that the
proposed values do not reflect the significant amount of planning and
effort required by the practitioner who furnishes these services, and
that undervaluation of CTS could lead to underutilization or access
issues for patients who would benefit from these services.
Response: We believe that the RUC-recommended valuations that we
have proposed to adopt reflect the typical inputs for the service. The
RUC's recommendations were based on extensive surveys with
psychologists, child and adolescent psychiatrists, and dieticians, and
represent the best information that we have at present for these new
codes. Additionally, the Caregiver Training Services CPT codes fall
appropriately between the key reference services used by the RUC to
compare the work RVU, total time, and related intensity of each
service. We believe that this supports the recommended values as
maintaining relativity with other similar services already listed on
the PFS.
After consideration of the public comments, we are finalizing our
proposed work RVUs and direct PE inputs for CPT codes 96202 and 96203.
Caregiver training in strategies and techniques to facilitate the
patient's functional performance (CPT codes 97550, 97551, and 97552)
(a) Coding
CPT codes 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), and add-on code, CPT code 97551 (each
additional 15 minutes (List separately in addition to code for primary
service) (Use 97551 in conjunction with 97550)), and 97552 (Group
caregiver training in strategies and techniques to facilitate the
patient's functional performance in the home or community (e.g.,
activities of daily living [ADLs], instrumental ADLs [IADLs],
transfers, mobility, communication, swallowing, feeding, problem
solving, safety practices) (without the patient present), face-to-face
with multiple sets of caregivers) were new codes created by the CPT
Editorial Panel during its October 2022 meeting. The three codes are to
be used to report the total duration of face-to-face time spent by the
physician or other qualified health professional providing individual
or group training to caregivers of patients. Although the patient does
not attend the trainings, the goals and outcomes of the sessions focus
on interventions aimed at improving the patient's ability to
successfully perform activities of daily living (ADL's). Activities of
daily living generally include ambulating, feeding, dressing, personal
hygiene, continence, and toileting.
During the face-to-face service time, caregivers are taught by the
treating practitioner how to facilitate the patient's activities of
daily living, transfers, mobility, communication, and problem-solving
to reduce the negative impacts of the patient's diagnosis on the
patient's daily life and assist the patient in carrying out a treatment
plan. These specific services are reasonable and necessary when
treating practitioners identify a need to involve and train caregivers
to assist the patient in carrying out a treatment plan. As part of an
individualized plan of care, the caregiver is trained in skills to
assist the patient in completing daily life activities. These trainings
to the caregiver include the development of skills such as safe
activity completion, problem solving, environmental adaptation,
training in the use of equipment or assistive devices, or interventions
focusing on motor, process, and communication skills.
(b) Valuation
The RUC recommended work values for CPT codes 97550, 97551, and
97552 based on the survey median values and the key reference CPT codes
97535 and 97130. The surveyed codes fall appropriately between these
key reference services compared to the work
[[Page 78920]]
RVU, total time, and related intensity of each service. Three specialty
societies sent surveys to a random sample of a subset of their members.
Based upon survey results and after discussion, the RUC recommended a
work RVU 1.00 for CPT code 97550, a work RVU of 0.54 for 97551, and a
work RVU of 0.23 per specific patient represented in the group service
being billed for CPT code 97552.
We proposed the RUC-recommended work RVU 1.00 for CPT code 97550,
the RUC-recommended work RVU of 0.54 for CPT code 97551, and the RUC-
recommended work RVU of 0.23 per identified patient service for CPT
code 97552. The RUC noted that the recommendation for 97552 is based on
a median group size of five caregivers. We also proposed the RUC-
recommended direct PE inputs for these codes.
Finally, we noted that the RUC recommendation included information
suggesting that the RUC intends to review the valuation of these
services again soon. We proposed to designate 97550, 97551, and 97552
as ``sometimes therapy'' services. This means 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: Commenters were generally supportive of the valuations of
these codes. A few commenters expressed concerns that the proposed
values do not reflect the significant amount of planning and effort
required by the practitioner who furnishes these services, and that
undervaluation of CTS could lead to underutilization or access issues
for patients who would benefit from these services. Commenters were
also supportive of CMS designating CPT codes 97550, 97551, and 97552 as
``sometimes therapy'' services.
Response: We believe that the RUC-recommended valuations that we
proposed reflect the typical inputs for the service. The RUC's
recommendations were based on extensive surveys with occupational
therapists, physical therapists, and speech language pathologists, and
represent the best information that we have at present for these new
codes. Additionally, the Caregiver Training Services CPT codes fall
appropriately between the key reference services used by the RUC to
compare the work RVU, total time, and related intensity of each
service. We believe that this supports the recommended values as
maintaining relativity with other similar services already listed on
the PFS. We also understand that the RUC may intend to review the
valuation of these services again soon--we will take potential updates
from the RUC into consideration in the future.
After consideration of the public comments, we are finalizing our
proposed work RVUs and direct PE inputs for CPT codes 97550, 97551, and
97552. We are also finalizing the designation of CPT codes 97550,
97551, and 97552 as ``sometimes therapy'' services.
(28) Services Addressing Health-Related Social Needs (Community Health
Integration Services, Social Determinants of Health Risk Assessment,
and Principal Illness Navigation Services)
a. Background
In recent years, we have sought to recognize significant changes in
health care practice and have been engaged in an ongoing, incremental
effort to identify gaps in appropriate coding and payment for care
management/coordination and primary care services under the PFS. See,
for example, our CY 2013, 2015, and 2017 PFS final rules, where we
finalized new coding to provide separate payment for transitional care
management services, chronic care management services, and behavioral
health care management services to improve payment accuracy to better
recognize resources involved in care management and coordination for
certain patient populations (77 FR 68978, 79 FR 67715 and 82 FR 53163,
respectively). To improve payment accuracy, we are exploring ways to
better identify and value practitioners' work when they incur
additional time and resources helping patients with serious illnesses
navigate the healthcare system or removing health-related social
barriers interfering with the practitioner's ability to execute a
medically necessary plan of care. Practitioners and their staff of
auxiliary personnel sometimes obtain information about and help address
social determinants of health (SDOH) that significantly impact the
practitioner's ability to diagnose or treat a patient. Additionally,
practitioners and their staff of auxiliary personnel sometimes help
newly diagnosed cancer patients and other patients with similarly
serious, high-risk illnesses navigate their care, such as helping them
understand and implement the plan of care and locate and reach the
right practitioners and providers to access recommended treatments and
diagnostic services, taking into account the personal circumstances of
each patient. Payment for these activities, to the extent they are
reasonable and necessary for the diagnosis and treatment of the
patient's illness or injury, is currently included in payment for other
services such as evaluation and management (E/M) visits and some care
management services. Medical practice has evolved to increasingly
recognize the importance of these activities, and we believe
practitioners are performing them more often. However, this work is not
explicitly identified in current coding, so we believe it is
underutilized and undervalued. Accordingly, we proposed to create new
coding to expressly identify and value these services for PFS payment,
and distinguish them from current care management services. We expect
that our new codes would also support the CMS pillars \9\ for equity,
inclusion, and access to care for the Medicare population and improve
patient outcomes, including for underserved and low-income populations
where there is a disparity in access to quality care. They would also
support the White House's National Strategy on Hunger, Nutrition and
Health, and the White House's Cancer Moonshot Initiative.\10\
---------------------------------------------------------------------------
\9\ CMS Strategic Plan [verbar] CMS.
\10\ White-House-National-Strategy-on-Hunger-Nutrition-and-
Health-FINAL.pdf (whitehouse.gov); Fact Sheet: President Biden
Reignites Cancer Moonshot to End Cancer as We Know It [verbar] The
White House https://www.whitehouse.gov/briefing-room/statements-releases/2022/02/02/fact-sheet-president-biden-reignites-cancer-moonshot-to-end-cancer-as-we-know-it/.
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As part of this effort, in the CY 2023 PFS final rule (87 FR 69551
through 69551), we issued a Request for Information (RFI) related to
Medicare Part B Payment for services involving community health workers
(CHWs). For CY 2024, we considered how we could better recognize,
through coding and payment policies, when members of an
interdisciplinary team, including CHWs, are involved in treatment of
Medicare beneficiaries. Currently, no separately enumerated statutory
Medicare benefit category provides direct payment to CHWs for their
services. Additionally, current HCPCS coding does not specifically
identify services provided by CHWs, even though CHWs may facilitate
access to healthcare through community-based services that are
necessary to alleviate barriers to care that are interfering with a
practitioner's ability to diagnosis or treat an illness or injury. In
rulemaking for the CY 2023 PFS, to gain a broader perspective on
[[Page 78921]]
CHWs and how we could refine our coding and payment policies to better
recognize their role in furnishing Medicare-covered services, we
solicited comment through an RFI on how services involving CHWs are
furnished in association with the specific Medicare benefits
established by the statute.
Commenters were supportive overall of potential, separate coding
and payment for services involving CHWs. The public comments indicated
that many physicians, practitioners, group practices, and other
entities currently utilize the services of CHWs to bridge gaps in the
continuum of their medical and behavioral healthcare furnished to
Medicare patients. In public comments on our RFI, interested parties
provided testimonials and evidence about the effectiveness of CHWs and
the services they provide to patients in the community by monitoring,
interpreting, clarifying, and supporting the plans of care that
physicians and practitioners establish for delivering care to patients.
In addition, in 2021, the AMA CPT Editorial Panel recognized in the
CPT E/M Guidelines that SDOH needs can increase complexity of a
practitioner's medical decision making (MDM) for an E/M visit and
increase risk to the patient, when diagnosis or treatment is
significantly limited by SDOH.\11\ Specifically, the CPT Editorial
Panel included as an example of moderate level MDM for E/M visit coding
and level selection, a situation where diagnosis or treatment is
significantly limited by SDOH. This situation is listed as an example
of moderate risk of morbidity from additional diagnostic testing or
treatment. The CPT E/M Guidelines defined SDOH as, ``Economic and
social conditions that influence the health of people and communities.
Examples may include food or housing insecurity.'' \12\ We adopted
these revised CPT guidelines for MDM in E/M visits through notice and
comment rulemaking, effective January 1, 2021 (84 FR 62844 through
62860, 87 FR 69587 through 69614).
---------------------------------------------------------------------------
\11\ 2021 CPT Codebook, p. 16.
\12\ 2021 CPT Codebook, p. 14.
---------------------------------------------------------------------------
Physicians and NPPs are generally trained to obtain a patient's
social and family history, in support of patient-centered care, to aid
in diagnosis, and to better understand and help address problem(s)
addressed in a medical visit and associated risk factors.\13\ For
example, a practitioner who discovers that a patient's living situation
does not permit reliable access to electricity may need to prescribe an
inhaler rather than a power-operated nebulizer to treat asthma. Some
practices and facilities employ social workers or other ancillary staff
to help address SDOH needs that impact the ability to provide medically
necessary care, such as appropriate treatment or diagnostic services
after an office visit or discharge from a facility.
---------------------------------------------------------------------------
\13\ See for example Patient-Centered Communication: Basic
Skills [verbar] AAFP; https://www.aafp.org/about/policies/all/social-determinants-health-family-medicine-position-paper.html;
https://doi.org/10.7326/M17-2441; .https://nam.edu/social-determinants-of-health-201-for-health-care-plan-do-study-act/;
https://www.ama-assn.org/system/files/2021-05/ama-equity-strategic-plan.pdf; https://edhub.ama-assn.org/steps-forward/module/2702762.
The Origins of the History and Physical Examination--Clinical
Methods--NCBI Bookshelf (nih.gov) https://www.ncbi.nlm.nih.gov/books/NBK458/.
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Practitioners are increasingly expending resources to obtain
information from the patient about SDOH and risks and formulate
diagnosis and treatment plans that consider these needs. We believe
that social workers, CHWs, and other auxiliary personnel are currently
performing some of these activities and that the resources involved in
these activities are not consistently appropriately reflected in
current coding and payment policies. As such, we believe it would be
appropriate to create codes to separately identify and more accurately
value this work. Accordingly, we proposed new coding to describe and
separately value three types of services that may be provided by
auxiliary personnel incident to the billing physician or practitioner's
professional services, and under the billing practitioner's
supervision, when reasonable and necessary to diagnose and treat the
patient: community health integration services, SDOH risk assessment,
and principal illness navigation. In our proposed rule, we discussed
the proposed codes and their valuation. We described the circumstances
under which we believe these services may be reasonable and necessary
for the diagnosis or treatment of illness or injury such that Medicare
payment may be made for them.
b. Community Heath Integration (CHI) Services
In light of the feedback we received from our RFI regarding CHWs,
and increased recognition within the medical community of the role that
social needs can play in patients' health (specifically, interfering
with ability to diagnose and treat patients), we proposed to establish
separate coding and payment for community health integration (CHI)
services. We proposed to create two new G codes describing CHI services
performed by certified or trained auxiliary personnel, which may
include a CHW, incident to the professional services, and under the
general supervision of the billing practitioner. We proposed that CHI
services could be furnished monthly, as medically necessary, following
an initiating E/M visit (CHI initiating visit) in which the
practitioner identifies the presence of SDOH need(s) that significantly
limit the practitioner's ability to diagnose or treat the problem(s)
addressed in the visit.
We proposed that the CHI initiating visit would be an E/M visit
(other than a low-level E/M visit that can be performed by clinical
staff) performed by the billing practitioner, who would also be
furnishing the CHI services during the subsequent calendar month(s).
The CHI initiating visit would be separately billed (if all
requirements to do so are met), and would be a pre-requisite to billing
for CHI services. We stated that certain types of E/M visits, such as
inpatient/observation visits, ED visits, and SNF visits, would not
typically serve as CHI initiating visits because the practitioners
furnishing the E/M services in those settings would not typically be
the ones to provide continuing care to the patient, including
furnishing necessary CHI services in the subsequent month(s).
The CHI initiating visit would serve as a pre-requisite to billing
for CHI services, during which the billing practitioner would assess
and identify SDOH needs that significantly limit the practitioner's
ability to diagnose or treat the patient's medical condition and
establish an appropriate treatment plan. The subsequent CHI services
would be performed by a CHW or other auxiliary personnel incident to
the professional services of the practitioner who bills the CHI
initiating visit. The same practitioner would furnish and bill for both
the CHI initiating visit and the CHI services, and CHI services must be
furnished in accordance with the ``incident to'' regulation at Sec.
410.26. We would not require an initiating E/M visit every month that
CHI services are billed, but only before commencing CHI services, to
establish the treatment plan, specify how addressing the unmet SDOH
need(s) would help accomplish that plan, and establish the CHI services
as incident to the billing practitioner's service. This framework is
similar to our current requirements for billing care management
services, such as chronic care management services. It also comports
with our longstanding policy in the Medicare Benefit Policy Manual,
which provides, ``where a physician supervises auxiliary personnel to
assist them in rendering services to patients
[[Page 78922]]
and includes the charges for their services in their bills, the
services of such personnel are considered incident to the physician's
service if there is a physician's service rendered to which the
services of such personnel are an incidental part. This does not mean,
however, that to be considered incident to, each occasion of service by
auxiliary personnel (or the furnishing of a supply) need also always be
the occasion of the actual rendition of a personal, professional
service by the physician. Such a service or supply could be considered
to be incident to when furnished during a course of treatment where the
physician performs an initial service and subsequent services of a
frequency which reflect their active participation in and management of
the course of treatment'' (Chapter 15, Section 60.1.B of the Medicare
Benefit Policy Manual (Pub. 100-02), available on our website at
https://www.cms.gov/regulations-and-guidance/guidance/manuals/downloads/bp102c15.pdf (cms.gov)).
We also solicited comment on whether we should consider any
professional services other than an E/M visit performed by the billing
practitioner as the prerequisite initiating visit for CHI services,
including, for example, an annual wellness visit (AWV) that may or may
not include the optional SDOH risk assessment. Under section
1861(hhh)(3)(C) of the Act, the AWV can be furnished by a physician or
practitioner or by other types of health professionals whose scope of
practice does not include the diagnosis and treatment involved in E/M
services, for example, a health educator. When the AWV is furnished by
other types of health professionals, it is not necessarily furnished
incident to the professional services of a physician or other
practitioner. Therefore, if we allowed an AWV to be furnished by a
health care practitioner other than a physician or practitioner to
serve as the initiating visit for CHI services, the CHI services would
not necessarily be furnished consistent with our proposed application
of the ``incident to'' regulations as a condition of payment. Further,
we believe that practitioners would normally bill an E/M visit in
addition to the AWV when medical problems are addressed in the course
of an AWV encounter, in accordance with our manual policy providing
that a medically necessary E/M visit may be billed when furnished on
the same occasion as an AWV in those circumstances (Chapter 12, Section
30.6.1.1.H of the Medicare Claims Processing Manual (Pub, 100-04).
The following is a summary of the comments we received and our
responses.
Comment: Commenters were generally supportive of our proposal to
establish CHI services, including allowing monthly furnishing of CHI
services, as medically necessary, following an initiating E/M visit
(CHI initiating visit).
Response: We thank the commenters for their feedback.
Comment: One commenter disagreed with the proposal to create new G
codes for CHI services and stated these codes may be duplicative of
both work and practice expenses already accounted for in existing CPT
codes. The commenter noted that the CPT Editorial Panel revised the E/M
visit coding and level selection to include an example of moderate
level medical decision making (MDM), accounting for clinical scenarios
when SDOH significantly limits diagnosis or treatment.
Response: We thank the commenter for noting the changes made by
CPT. However, we believe the new G codes will describe and account for
integrated services supported by certified or trained auxiliary
personnel, including CHWs, who will assist the practitioner in
connecting the patient with helpful resources. This is separate from
the work being furnished as part of the medical decision-making in an
E/M visit and want to reiterate that CHI services are separate and
different from an E/M service. These new services, further described in
the code descriptors below, consist of activities to address social
determinants of health (SDOH) need(s) that are significantly limiting
the practitioner's ability to diagnose or treat problem(s) addressed in
an initiating CHI visit. These services include a person-centered
assessment, practitioner, home-, and community-based care coordination,
health education, building patient self-advocacy skills, health care
access/health system navigation, facilitating and providing social and
emotional support, and leveraging lived experience when applicable. We
recognize that CPT recently revised its evaluation and management (E/M)
code set to include language that pertains to diagnosis or treatment
significantly limited by social determinants of health as an element of
medical decision making, however the CHI services to address the SDOH
limitations are not captured in the revised E/M codes. It is for this
reason that we proposed new coding to account for the services that are
not accounted for in the E/M code set. We believe the services
described by the CHI codes will help to resolve the patient's health
related social needs that are impacting their care and the
practitioner's ability to properly diagnose and treat the patient.
Comment: A few commenters requested that CMS clarify whether these
services can be billed at safety-net clinics in academic medical
centers. Commenters also raised concerns that academic medical centers
and other facility-based providers could not furnish the services,
given the reliance on incident to billing. Commenters requested that
CMS clarify how such facilities may furnish these services to ensure
that patients can benefit from the services regardless of where they
receive their care.
Response: We thank the commenters for their feedback and
acknowledge that there are aspects of the policy that we must consider
further for possible future rulemaking. As proposed, these services can
only be furnished and billed by physicians and practitioners who can
bill for services performed by auxiliary personnel incident to their
professional services.
Comment: Some commenters sought clarification on whether the full
range of qualified health professionals permitted to bill E/M codes
would also be permitted to bill HCPCS code G0019.
Response: Our final policy requires the individual billing for the
initiating visit to be the same as the practitioner billing for CHI. In
order to bill for these services, practitioners must have a statutory
benefit and be able to enroll and bill Medicare as they would for other
services on the fee schedule and specifically be able to bill an E/M
service that would serve as the initiating visit.
Comment: Some commenters requested CMS allow CHWs to enroll in
Medicare as a type of practitioner that can bill directly and be paid
for their services, and that CBOs be able to bill Medicare directly for
the CHI services if they have a NPI number.
Response: There is no statutory benefit category that would allow
CBOs to bill the PFS directly. Therefore, we are not finalizing such a
policy.
Comment: One commenter stated that CMS does not have the statutory
authority to implement separate payment for CHW services as a new
benefit category. Other commenters requested that CMS seek authority
and funding from Congress before establishing a new Medicare social
services benefit category.
Response: We note that CHI services will be furnished and billed
incident to the professional services of the billing practitioner. As
such, only physicians and other types of practitioners that are
[[Page 78923]]
authorized by statute to enroll and bill the PFS directly will be
included among those who can bill for CHI services. We clarify that our
final policy will not create a new Medicare benefit category but
instead allow CHI services to be furnished incident to the professional
services of a billing practitioner. When diagnosis or treatment of a
patient's medical condition is significantly limited by social
determinants of health, we believe that these services are within the
scope of medically necessary physicians' services, and that payment for
them is permitted when the services are reasonable and necessary under
section 1862(a)(1)(A) of the Act. We clarify that CHI services are
consistent with the ``incident to physicians' services'' benefit
category under section 1861(s)(2)(A) of the Act.
Comment: Some commenters expressed concern with the CHI initiating
visit being limited only to E/M visits and asserted that doing so would
restrict access to the service as proposed. Commenters requested that
the following services that are not E/M visits, be allowed to serve as
an initiating visit: AWV, CPT codes 90791 (Psychiatric diagnostic
evaluation) and 96156 ((Health behavior assessment, or re-assessment
(i.e., health-focused clinical interview, behavioral observations,
clinical decision making))
Response: Regarding whether the CHI initiating visit can be an AWV,
we solicited comment on this topic and having considered the public
comments, we are finalizing that the AWV can be a CHI initiating visit
when the furnishing practitioner identifies an unmet SDOH need that
will prevent the patient from carrying out the recommended personalized
prevention plan. We believe that, in these cases, it could be
reasonable and necessary for the practitioner furnishing the AWV to
furnish CHI services. There may be instances where the identification
of SDOH needs through an SDOH risk assessment conducted with the AWV
could identify and produce the conditions for reasonable and necessary
CHI services, for example, when the practitioner furnishing the AWV is
assuming ongoing ``longitudinal'' care for the patient. However, when
the AWV is provided by a type of health care professional who does not
have an ``incident to'' benefit for their services under the Medicare
program, including, for example, a health educator, a registered
dietitian, or nutrition professional, the AWV would not serve as an
initiating visit for CHI because the furnishing professional could not
then furnish and bill for CHI services incident to their professional
services. Even if we allow AWV to be the initiating visit, the AWV
would still need to be furnished by a physician or practitioner,
consistent with the incident to rules so that services for CHI can be
billed by a practitioner incident to their own professional services.
We continue to believe that when an AWV involves diagnosis or
treatment of injury or illness to the degree that would warrant
subsequent furnishing and billing of CHI to remove barriers
significantly limiting the treatment plan, in most cases, an E/M visit
would be separately billed.
While we considered adding services provided by clinical
psychologists, specifically CPT codes 90791 and 96156 to the list of
services that could serve as an initiating visit for CHI services based
on feedback received from commenters, we are not including these
services as services that can serve as an initiating visit for CHI. We
believe that these services would be better captured under the PIN
services discussed below and would better serve the needs being
addressed with the PIN service elements. However, we will continue to
analyze the uptake of CHI services and will consider these comments for
future rulemaking.
Comment: Commenters wanted CMS to allow emergency department E/M
visits, inpatient/observation E/M visits, and transitional care
management services to serve as initiating visits for CHI.
Response: In response to the commenters, we note that inpatient/
observation visits and ED visits could not serve as CHI initiating
visits, as conceptualized in this final rule and the proposed rule,
because the practitioners furnishing the E/M services in those settings
would not typically provide continuing care to the patient, including
furnishing necessary CHI services in the subsequent month(s) following
a potential initiating visit. Additionally, under our regulations at
Sec. 410.26(b), Medicare payment is only made for services and
supplies incident to the service of a physician or other practitioner
(such as the proposed CHI services) when those services and supplies
are furnished in a noninstitutional setting to noninstitutional
patients (all settings other than a hospital or SNF). So, under our
current regulations and the CHI policies that we are finalizing in this
rule, an E/M service furnished in the ED or SNF setting would not serve
as the initiating visit for CHI services.
ED visits, as well as inpatient and observation visits would not be
an initiating visit since these practitioners would not be following
the patient longitudinally in the community or furnishing the CHI
services.
Response: As discussed above, ED visits would not typically serve
as CHI initiating visits because the practitioners furnishing the E/M
services in those settings would not typically provide continuing care
to the patient, including furnishing necessary CHI services incident to
their professional services in the month(s) subsequent to an ED visit.
We agree with commenters that the E/M visit done as part of a
Transitional Care Management (TCM) services could serve as an
initiating visit for CHI services because it includes a high level
office/outpatient E/M visit furnished by a physician or nonphysician
practitioner managing the patient in the community after discharge.
Comment: Commenters also expressed concern with our proposal to
allow only one practitioner to furnish a CHI initiating visit and
requested that CMS allow more than one practitioner to furnish and bill
the CHI initiating visit and services. Additionally, a few commenters
requested that CMS clarify whether more than one initiating visit would
be required when a subsequent need for CHI is identified during the
initiating visits.
Response: We continue to be concerned that CHI services would be
too fragmented if the patient has more than individual addressing their
unmet SDOH need(s). Therefore, we are finalizing that only one
practitioner will bill CHI and therefore there will only be one
initiating visit. We acknowledge that practitioners may identify
additional SDOH that are significantly limiting their ability to
diagnose or treat the problem(s) address addressed in the initiating
visit. We provide additional discussion with regard to the service
elements below.
After consideration of the public comments, we are finalizing our
proposal to establish separate coding and payment for CHI services. We
are finalizing that a CHI initiating visit can be an E/M visit (other
than a low-level E/M visit that can be performed by clinical staff)
performed by the billing practitioner who would also be furnishing the
CHI services during the subsequent calendar month(s), including an E/M
visit furnished as part of TCM, or an AWV. The CHI initiating visit
would be separately billed (if all requirements to do so are met) and
would be a pre-requisite to billing for CHI services.
In the proposed rule, for purposes of assigning a supervision level
for these ``incident to'' services, we proposed to designate CHI
services as care management services that may be
[[Page 78924]]
furnished under the general supervision of the billing practitioner in
accordance with Sec. 410.26(b)(5). General supervision means the
service is furnished under the physician's (or other practitioner's)
overall direction and control, but the physician's (or other
practitioner's) presence is not required during the performance of the
service (Sec. 410.26(a)(3)).
In the proposal, we explained that the phrase or term ``problem
addressed'' referred to the definition in the CPT E/M Guidelines that
we adopted for E/M visits. Specifically, ``[a] problem is a disease,
condition, illness, injury, symptom, finding, complaint, or other
matter addressed at the encounter, with or without a diagnosis being
established at the time of the encounter. Problem addressed [means the
following]: A problem is addressed or managed when it is evaluated or
treated at the encounter by the physician or other qualified healthcare
professional reporting the service. This includes consideration of
further testing or treatment that may not be elected by virtue of risk/
benefit analysis or patient/parent/guardian/surrogate choice. Notation
in patient's medical record that another professional is managing the
problem without additional assessment or care coordination documented
does not qualify as being addressed or managed by the physician or
other qualified healthcare professional reporting the service. Referral
without evaluation (by history, examination, or diagnostic study[ies])
or consideration of treatment does not qualify as being addressed or
managed by the physician or other qualified healthcare professional
reporting the service. For hospital inpatient and observation care
services, the problem addressed is the problem status on the date of
the encounter, which may be significantly different than on admission.
It is the problem being managed or co-managed by the reporting
physician or other qualified healthcare professional and may not be the
cause of admission or continued stay'' (2023 CPT Codebook, p. 6-8).
For purposes of CHI services (and PIN services outlined later in
this section), we proposed that SDOH means economic and social
condition(s) that influence the health of people and communities, as
indicated in these same CPT E/M Guidelines (2023 CPT codebook, page
11). We proposed to adopt CPT's examples of SDOH, with additional
examples. Specifically, we proposed that SDOH(s) may include but are
not limited to food insecurity, transportation insecurity, housing
insecurity, and unreliable access to public utilities, when they
significantly limit the practitioner's ability to diagnose or treat the
problem(s) addressed in the CHI initiating visit. Since Medicare
payment is generally limited to items and services that are reasonable
and necessary for the diagnosis or treatment of illness or injury, the
focus of CHI services would need to be on addressing the particular
SDOH need(s) that are interfering with, or presenting a barrier to,
diagnosis or treatment of the patient's problem(s) addressed in the CHI
initiating visit.
We proposed the following specific codes and descriptors:
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, in the following activities to address social
determinants of health (SDOH) need(s) that are significantly limiting
ability to diagnose or treat problem(s) addressed in an initiating E/M
visit:
Person-centered assessment, performed to better understand
the individualized context of the intersection between the SDOH need(s)
and the problem(s) addressed in the initiating E/M visit.
++ Conducting a person-centered assessment to understand patient's
life story, strengths, needs, goals, preferences and desired outcomes,
including understanding cultural and linguistic factors.
++ Facilitating patient-driven goal-setting and establishing an
action plan.
++ Providing tailored support to the patient as needed to
accomplish the practitioner's treatment plan.
Practitioner, Home-, and Community-Based Care
Coordination.
++ Coordinating receipt of needed services from healthcare
practitioners, providers, and facilities; and from home- and community-
based service providers, social service providers, and caregiver (if
applicable).
++ Communication with practitioners, home- and community-based
service providers, hospitals, and skilled nursing facilities (or other
health care facilities) regarding the patient's psychosocial strengths
and needs, functional deficits, goals, preferences, and desired
outcomes, including cultural and linguistic factors.
++ Coordination of care transitions between and among health care
practitioners and settings, including transitions involving referral to
other clinicians; follow-up after an emergency department visit; or
follow-up after discharges from hospitals, skilled nursing facilities
or other health care facilities.
++ Facilitating access to community-based social services (e.g.,
housing, utilities, transportation, food assistance) to address the
SDOH need(s).
Health education--Helping the patient contextualize health
education provided by the patient's treatment team with the patient's
individual needs, goals, and preferences, in the context of the SDOH
need(s), and educating the patient on how to best participate in
medical decision-making.
Building patient self-advocacy skills, so that the patient
can interact with members of the health care team and related
community-based services addressing the SDOH need(s), in ways that are
more likely to promote personalized and effective diagnosis or
treatment.
Health care access/health system navigation.
++ Helping the patient access healthcare, including identifying
appropriate practitioners or providers for clinical care and helping
secure appointments with them.
Facilitating behavioral change as necessary for meeting
diagnosis and treatment goals, including promoting patient motivation
to participate in care and reach person-centered diagnosis or treatment
goals.
Facilitating and providing social and emotional support to
help the patient cope with the problem(s) addressed in the initiating
visit, the SDOH need(s), and adjust daily routines to better meet
diagnosis and treatment goals.
Leveraging lived experience when applicable to provide
support, mentorship, or inspiration to meet treatment goals.
G0022--Community health integration services, each additional 30
minutes per calendar month (List separately in addition to G0019).
By way of example, tailored support could be provided through CHI
services to a patient experiencing homelessness with signs of potential
cognitive impairment and a history of frequent ED admissions for
uncontrolled diabetes. The patient's primary care practitioner (PCP)
learns during a clinic visit after discharge from the ED, that the
patient has been able to reliably fill their prescriptions for diabetes
medication, but frequently loses the medication (or access to it) while
transitioning between homeless shelters and a local friend's home. In
the medical record, the PCP documents SDOH need(s) of housing
insecurity and transportation insecurity contributing to medication
noncompliance, resulting in inadequate
[[Page 78925]]
insulin control and a recent ED visit for hypoglycemia. The PCP's
treatment plan is daily diabetes medication, with the goal of
maintaining hemoglobin A1c within appropriate levels. To accomplish the
treatment plan, the PCP orders CHI services to develop an
individualized plan for daily medication adherence/access while
applying for local housing assistance, and also orders a follow up
visit for cognitive impairment assessment and care planning to further
evaluate the potential contribution of cognitive impairment. The PCP's
auxiliary personnel provide tailored support, comprised of facilitating
communication between the patient, local shelters, and the friend, to
help the patient identify a single location to reliably store their
medication while applying for local housing assistance. The auxiliary
personnel also help the patient identify a reliable means of
transportation daily to that location for their medication and show the
patient how to create a daily automated phone reminder to take the
diabetes medication. The auxiliary personnel document these activities
(including amount of time spent) in the medical record at the PCP's
office, along with periodic updates regarding the status of the
patient's housing assistance application.
To help inform whether our proposed descriptor times were
appropriate and reflect typical service times, and whether a frequency
limit is relevant for the add-on code, we solicited comment on the
typical amount of time practitioners spend per month furnishing CHI
services to address SDOH needs that pose barriers to diagnosis and
treatment of problem(s) addressed in an E/M visit. We also solicited
comment to better understand the typical duration of CHI services, in
terms of the number of months for which practitioners furnish the
services.
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 allow general
supervision for CHI services. However, some commenters asked a related
question about whether auxiliary personnel providing CHI services under
general supervision can identify additional unmet SDOH needs to
address. When CHI services are being furnished, sometimes a patient is
receiving CHI services to address one unmet SDOH need, and in the
course of auxiliary personnel providing CHI services during the month,
the auxiliary personnel identify additional unmet SDOH need(s). These
commenters recommended that if the auxiliary personnel are regularly
updating the billing practitioner on CHI services they provide, we
should not require another initiating visit in order for the auxiliary
personnel to address the additional unmet SDOH needs.
Response: We thank the commenters support of our proposal for
general supervision. It would not be in the scope of practice of the
auxiliary personnel for them to make a determination that a given SDOH
need(s) is impacting ability of the billing practitioner to diagnose or
treat problems addressed in an initiating visit. In addition, general
supervision requires the CHI services to be furnished under the billing
practitioner's direction and control. While we do not believe another
initiating visit is necessary, the auxiliary personnel must review all
unmet SDOH need(s) they find in order for them to be addressed by the
billing practitioners in the CHI services.
Comment: Some commenters also stated that general supervision could
inadvertently lead to the consolidation and integration of CHWs and
other auxiliary personnel currently employed by CBOs to instead be
employed by billing practitioners, where payment may be more robust,
Response: There is no statutory benefit that can allow CBOs to
directly bill the PFS. In accordance with this final rule, CHI services
must be provided incident to the professional service of a physician or
other statutorily qualified practitioner who must bill for those
services. Auxiliary personnel who provide these services must be under
the supervision of the physician [or other practitioner] and the
provided services must be reasonable and necessary for diagnosis and
treatment of illness or injury. In the course of implementing our
payment policy for chronic care management services, we became
concerned about the number of care management companies that were
contracted by the physician with potentially little oversight, clinical
integration and communication with the billing practitioner, where the
services might not be furnished under the direction and control of the
billing practitioner. As discussed above, we were concerned that our
incident to policy might not be met, which requires the billing
practitioner to maintain active participation in and management of the
course of treatment. We are allowing for the broadest level of
supervision possible (general supervision) and contracting with third
parties (such as CBOs) in accomplishing the furnishing of CHI services
but this must be part of clinical care and treatment by the billing
practitioner. Under our incident to regulations, we cannot prohibit
physicians from directly hiring auxiliary personnel for furnishing CHI
services.
Comment: Commenters were generally supportive of assigning general
supervision for CHI services.
Response: We thank commenters for supporting our proposal to assign
general supervision for the CHI codes. We believe that general
supervision offers flexibility for the auxiliary personnel to provide
the CHI services without the billing practitioner being physically
present or immediately available, as would be required under direct or
personal supervision (see Sec. 410.26).
Comment: Another commenter recommended that the services provided
by a CHW should be provided under the supervision of a qualified health
professional providing care management activities, including, but not
limited to registered nurses.
Response: No, our regulations require supervision by the
practitioner who bills for the services.
Comment: Commenters were overall supportive of the valuation for
HCPCS codes G0019 and G0022. Some commenters requested that CMS
consider 20- or 30-minute increments for HCPCS code G0019, or other
shorter increments, that could be billed individually, or as multiple
units during the same encounter, with a maximum per calendar month of
no less than 60 minutes total. One commenter also requested that HCPCS
code G0019 be extended to 120 minutes and HCPCS code G0022 be extended
up to 60 minutes per calendar month. A few commenters stated 30 minutes
was sufficient, but the majority of commenters stated they spend 60
minutes up to 120 minutes, especially during the first few months.
Response: We asked commenters what they believe is the typical
amount of time practitioners spend per month furnishing CHI services to
address SDOH needs that pose barriers to diagnosis and treatment of
problem(s) addressed. Commenters suggested a broad range of the time
they expected to spend furnishing CHI services over a month. We are not
finalizing a frequency limitation for the add on HCPCS code G0022 to
allow for flexibility when practitioners do spend more than 60 minutes
on CHI services in the month. Commenters expressed that for CHI
services, especially during the first month, more time may be spent on
providing services. We believe it is difficult to adequately address a
[[Page 78926]]
patient's social needs, consistent with the proposed elements of the
CHI service, in less than an hour. As a result, we continue to believe
that the 60 minutes of time spent by auxiliary personnel is most
appropriate. For HCPCS code G0022, we continue to believe that 30
minutes of time spent by auxiliary personnel is most appropriate for
the code descriptor. Therefore, we are finalizing 60 minutes for the
base code and 30 minutes for the add-on code with no frequency
limitation for the add-on code as long as the time spent is reasonable
and necessary.
Comment: Several commenters requested that CMS include social
workers and registered nurses in the code descriptors for HCPCS codes
G0019 and G0022. Commenters also requested that these professionals be
included as personnel who may conduct the initial CHI visit and oversee
the provision of these services. Commenters also requested that CMS
identify social workers, including a bachelor of social work (BSW), as
eligible auxiliary workforce under CHI and PIN. Commenters expressed
that including social workers is especially important as auxiliary
personnel are employed by community care hubs (CCHs) and/or individual
community-based organizations (CBOs) that may be contracting with a
Medicare billing provider, and BSWs make up a significant part of this
workforce. Another commenter stated that social workers provide
services aligned with these proposed codes day in and day out across
the country, yet they are not identified among lists of providers
recognized for offering these proposed services.
Response: We note that our HCPCS G-code descriptors specify that
auxiliary personnel may provide these services under general
supervision. These codes were specifically designed to capture services
commonly performed by community health workers, which are a type of
auxiliary personnel. But 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).
Comment: Some commenters supported our proposal to establish CHI
services described by HCPCS code G0019 and stated the code should only
be billed by one practitioner, to maintain longitudinal care. Other
commenters did not agree with our proposed limitation for CHI and PIN
services to one billing practitioner per patient per calendar month,
and requested that we not impose such a limit. One commenter expressed
that limiting CHI services to one practitioner per patient per month
would impair the ability of auxiliary personnel to provide CHI services
to the patient. Most commenters opposed our proposal that the add-on
service, HCPCS code G0022, could be billed only once per month. Some
commenters suggested that practitioners should be allowed to bill HCPCS
code G0022 at least once a week. Another commenter expressed concern
regarding frequency limits for the CHI add-on code and noted that
spending adequate time with patients will be essential for high-quality
CHI service provision. Another commenter requested not limiting the
number of add-on services per month or the length of time a patient can
continue to receive CHI or PIN services and expressed that if a patient
needs services beyond six months, for example, a new order from the
billing practitioner could be submitted. Several commenters recommended
that CHI services have one in person interaction per month and
expressed it was critical to allow the add on service (HCPCS code
G0022) to be billed weekly.
One commenter noted that most beneficiaries screened for SDOH had
two to five SDOH needs and to address those identified needs, it was
conceivable that the CHI services would occur over multiple months
(when more than one need was identified). The commenter noted that they
would anticipate more intensity/time spent with the patient during the
first month, while subsequent months may not have the same intensity or
time spent, and that time spent delivering CHI services would be
aggregated to determine the total time spent, per calendar month. Some
commenters asserted that they could typically spend up to 120 minutes
providing CHI services in the first month.
Response: We thank the commenters for their suggestions regarding
frequency limitations for the CHI codes, specifically the add-on code,
HCPCS code G0022. We are not finalizing to establish a frequency
limitation for HCPCS code G0022. Considering the feedback from the
commenters, we understand that it may be typical for practitioners and
auxiliary staff to spend significant time supporting the activities
described by the CHI codes during the first month. We believe as long
as the time spent by auxiliary personnel is reasonable and necessary
for the diagnosis and treatment of injury or illness, we should allow
it to be billed. We agree with commenters that there could be
situations where a patient requires more intensive CHI services over a
month that would warrant billing more than one unit of the add-on HCPCS
code G0022, perhaps especially in the first month and where multiple
health related social needs impact the practitioner's ability to
diagnose and treat the patient. We will monitor utilization in the
claims data of the add-on code for medical necessity.
Comment: Several commenters recommended that we create a separate
HCPCS code for CHI services performed in a group setting. These
commenters expressed that certain service elements such as health
education and facilitating behavior change, may be provided to patients
as part of a group session with other patients. The commenter expressed
that many patients benefit from services provided to a group of similar
patients similar challenges.
Response: We did not propose a code describing services furnished
to a group of patients. CHI services are highly individualized and
focused on a person-centered assessment, performed to better understand
the individualized context of the intersection between the SDOH need(s)
and the problem(s) addressed in the initiating visit and subsequently
by the CHW and/or auxiliary personnel in the community. Therefore, we
continue to believe that the service should be tailored to address the
individual patient's specific needs, and did not consider whether it
would be appropriate for CHI services to be furnished in a group
setting.
Comment: Many commenters asked whether the new G codes for CHI
could be excluded from budget neutrality.
Response: We remind commenters that section 1848(c)(2)(B)(ii)(II)
of the Act requires that increases or decreases in RVUs may not cause
the amount of Medicare Part B expenditures for the year to differ by
more than $20 million from what expenditures would have been in the
absence of these changes. If this threshold is exceeded, we make
adjustments to preserve budget neutrality. There is no statutory
exception available for CHI services, so the expected spending
associated with these services must be included in the CY 2024 BN
adjustment.
Comment: Several commenters expressed concern regarding the medical
record documentation requirements for CHI services and requested that
CMS clarify that services must be documented by the billing
practitioner and not necessarily by the
[[Page 78927]]
auxiliary staff delivering the services. This arrangement would allow a
CBO to communicate with the billing practitioner about the services
provided (including the time spent furnishing services and the social
needs addressed), without requiring CBOs to have the technical capacity
to directly input documentation into medical records. Other commenters
stated that the billing practitioner or the auxiliary personnel should
be responsible for documenting CHI and PIN services in the Electronic
Medical Record (EMR).
Response: We thank the commenters for requesting clarification
regarding documentation in the medical record, including an EMR, by the
auxiliary personnel. We refer commenters to the finalized policies
about medical record documentation in the CY 2020 PFS final rule (84 FR
62681 through 62684) and our later clarifications in the CY2021 PFS
final rule (85 FR 84594 through 84596), which state that any individual
who is authorized under Medicare law to furnish and bill for their
professional services, whether or not they are acting in a teaching
role, may review and verify (sign and date) the medical record for the
services they bill, rather than re-document notes in the medical record
made by physicians, residents, nurses, and students (including students
in therapy or other clinical disciplines), or other members of the
medical team. Documentation, in the end, is the responsibility of the
billing practitioner. CBOs may enter data following our general policy,
as long as the biller reviews and verifies the documentation.
After consideration of the public comments, we are finalizing our
proposal to designate CHI services as care management services that may
be furnished under the general supervision of the billing practitioner
in accordance with Sec. 410.26(b)(5). We are also finalizing the
proposed code descriptor for HCPCS code G0019, with a few minor
changes. The final code descriptor for HCPCS code G0019, states that
CHI services performed by certified or trained auxiliary personnel,
including a community health worker, under the direction of a physician
or other practitioner requires 60 minutes per calendar month to bill
the service. We are also finalizing the valuation for HCPCS code G0019
as proposed. We are also finalizing the proposed code descriptor and 30
minutes per calendar month for HCPCS code G0022 as proposed.
Additionally, we are not finalizing a frequency limitation for HCPCS
code G0022. We will monitor utilization of the add-on HCPCS code G0022
and may re-evaluate these policies in future rulemaking.
With regard to changes in our final code descriptor, we are
modifying the descriptor to reflect the policy we are finalizing in
response to public comments received. We removed `E/M' from the code
descriptor since we are finalizing a policy to allow an E/M service,
including an E/M service that is part of a TCM service, and an AWV
service to serve as the initiating visit for CHI services.
Additionally, we are adding a service element for the SDOH risk
assessment to describe instances when a CHW or other auxiliary
personnel performing CHI services identifies an SDOH need that the
furnishing practitioner did not identify and needs to apprise the
billing practitioner of that unmet SDOH need(s) they find for the need
to be addressed by the billing practitioners and for the billing
practitioner to identify if that need would impact the ability of the
billing practitioner to diagnose and treat the problem addressed in the
initiating visit .
We are finalizing the code descriptor for HCPCS code G0019 to read
as follows:
Community health integration services performed by certified or
trained auxiliary personnel, including a community health worker, under
the direction of a physician or other practitioner; 60 minutes per
calendar month, in the following activities to address social
determinants of health (SDOH) need(s) that are significantly limiting
the ability to diagnose or treat problem(s) addressed in an initiating
visit:
Person-centered assessment, performed to better understand
the individualized context of the intersection between the SDOH need(s)
and the problem(s) addressed in the initiating visit.
++ Conducting a person-centered assessment to understand patient's
life story, strengths, needs, goals, preferences and desired outcomes,
including understanding cultural and linguistic factors and including
unmet SDOH needs (that are not separately billed).
++ Facilitating patient-driven goal-setting and establishing an
action plan.
++ Providing tailored support to the patient as needed to
accomplish the practitioner's treatment plan.
Practitioner, Home-, and Community-Based Care Coordination
++ Coordinating receipt of needed services from healthcare
practitioners, providers, and facilities; and from home- and community-
based service providers, social service providers, and caregiver (if
applicable).
++ Communication with practitioners, home- and community-based
service providers, hospitals, and skilled nursing facilities (or other
health care facilities) regarding the patient's psychosocial strengths
and needs, functional deficits, goals, preferences, and desired
outcomes, including cultural and linguistic factors.
++ Coordination of care transitions between and among health care
practitioners and settings, including transitions involving referral to
other clinicians; follow-up after an emergency department visit; or
follow-up after discharges from hospitals, skilled nursing facilities
or other health care facilities.
++ Facilitating access to community-based social services (e.g.,
housing, utilities, transportation, food assistance) to address the
SDOH need(s).
Health education--Helping the patient contextualize health
education provided by the patient's treatment team with the patient's
individual needs, goals, and preferences, in the context of the SDOH
need(s), and educating the patient on how to best participate in
medical decision-making.
Building patient self-advocacy skills, so that the patient
can interact with members of the health care team and related
community-based services addressing the SDOH need(s), in ways that are
more likely to promote personalized and effective diagnosis or
treatment.
Health care access/health system navigation
++ Helping the patient access healthcare, including identifying
appropriate practitioners or providers for clinical care and helping
secure appointments with them.
Facilitating behavioral change as necessary for meeting
diagnosis and treatment goals, including promoting patient motivation
to participate in care and reach person-centered diagnosis or treatment
goals.
Facilitating and providing social and emotional support to
help the patient cope with the problem(s) addressed in the initiating
visit, the SDOH need(s), and adjust daily routines to better meet
diagnosis and treatment goals.
Leveraging lived experience when applicable to provide
support, mentorship, or inspiration to meet treatment goals.
The commenters did not suggest any changes to the add-on code
descriptor so for the add-on HCPCS code G0022 we are not finalizing any
changes and the descriptor will read as follows: HCPCS code G0022--
Community health integration services, each additional 30
[[Page 78928]]
minutes per calendar month (List separately in addition to G0019).
In the proposed rule, we proposed that all auxiliary personnel who
provide CHI services must be certified or trained to perform all
included service elements and authorized to perform them under
applicable State laws and regulations. Under Sec. 410.26(a)(1) of our
regulations, auxiliary personnel must meet any applicable requirements
to provide the services performed incident to the billing
practitioner's professional services, including licensure, that are
imposed by the State in which the services are being furnished. In
States where there are no applicable licensure or other laws or
regulations relating to individuals performing CHI services, we
proposed to require auxiliary personnel providing CHI services to be
trained to provide them. Training must include the competencies of
patient and family communication, interpersonal and relationship-
building skills, patient and family capacity-building, service
coordination and system navigation, patient advocacy, facilitation,
individual and community assessment, professionalism and ethical
conduct, and the development of an appropriate knowledge base,
including of local community-based resources. We proposed these
competencies because they reflect professional consensus regarding
appropriate core competencies for CHWs, applied to this context.\14\ We
solicited public comment on whether it would be appropriate to specify
the number of hours of required training, as well as the training
content and who should provide the training.
---------------------------------------------------------------------------
\14\ https://chwtraining.org/c3-project-chw-skills/.
---------------------------------------------------------------------------
The following is a summary of the comments we received and our
responses.
Comment: Most commenters generally agreed with our proposal. Some
commenters expressed that a minimum number of training hours is needed
to ensure basic skills and understanding related to the CHW scope of
work. Other commenters noted that training should be development-
oriented and not be a one-time certification. Some commenters expressed
that CHWs, and the associations that represent them, are best
positioned to determine the appropriate training requirements to
balance patient safety and access to care. Commenters also expressed
that there should be flexibility in training and certification
requirements to support the development of a diverse CHI services
workforce.
Several commenters noted they utilize the Community Health Worker
Core Competency (C3) project. A few commenters agreed that training
should not focus on clinical topics as CHWs are not trained clinicians
or health educators. Other commenters also suggested and agreed that
when there are no applicable licensure or State laws related to
individuals performing CHI, services should align with the C3 Project
competencies.
Response: We continue to believe that our rules for all incident to
services should apply such that applicable State rules and requirements
must be met and that training/certification must meet any applicable
requirements to provide the services performed incident to the billing
practitioner's professional services, including licensure, that are
imposed by the State.
Comment: Some commenters disagreed with our proposal to require
auxiliary personnel providing CHI services to be trained. These
commenters suggested that CMS offer a legacy certification option for
CHWs with extensive lived experience.
Response: We thank commenters for their feedback. We do not
understand what the commenters mean by legacy certification. We
continue to believe that we should defer to States, as they have
applicable standards for auxiliary personnel (as specified for all
incident to services under Sec. 410.26). For States without a standard
for training or certification, that we believe that we should adopt the
professional consensus regarding appropriate core competencies for CHI
services, applied to this context.
Comment: While some commenters stated that requiring a specific
number of training hours may be a deterrent for some individuals to
actually obtain the required training, others suggested auxiliary
personnel providing CHI services should participate in training
programs with anywhere from 7 to 10 hours, 30 to 40 hours, and up to
140 hours before beginning work. Other commenters recommended an annual
training requirement of 2 to 3 hours.
Response: We thank the commenters for their thoughts and
suggestions on whether it would be appropriate to specify the number of
hours of required training, as well as the training content and who
should provide the training to be obtained by CHWs. We did not propose
and do not plan to finalize a specific number of hours of training for
auxiliary personnel providing CHI services.
After consideration of the public comments, we are finalizing our
proposal that all auxiliary personnel who provide CHI services must be
certified or trained to perform all included service elements, and
authorized to perform them under applicable State laws and regulations.
For CHI services, as with all incident to services, it is the
billing practitioner's responsibility to ensure that all payment rules
and applicable State requirements are met including licensure,
certification, and/or training. This does not mean that the billing
practitioners are required to provide the licensure, certification,
and/or training themselves, but rather that they must ensure that the
Medicare criteria for billing and payment of CHI services are met.
We continue to believe that the training required to provide CHI
services must include the competencies of patient and family
communication, interpersonal and relationship-building, patient and
family capacity-building, service coordination and system navigation,
patient advocacy, facilitation, individual and community assessment,
professionalism and ethical conduct, and the development of an
appropriate knowledge base, including of local community-based
resources.
Because we defer to applicable State rules, we are not requiring a
set number of training hours or content in States that have applicable
rules. For States that do not have applicable rules, we continue to
believe that our proposed competencies as specified above are
appropriate. Due to the wide range of training hours suggested by
commenters, we are not specifying a required number of training hours
that need to be obtained in States who do not have an applicable rule
to specify the number of required hours.
Comment: One commenter suggested a national certification mechanism
and to call these personnel certified Community Health Professionals
(CCHPs). Some commenters expressed that there should be a program-level
accreditation that recognizes community-based organizations that are
employing community-health workers, and pointed to accrediting bodies
that have plans in the works for such accreditations.
Response: We are not sure whether the commenter is recommending a
national accreditation for CHI services, CHWs, or CBOs. PFS payment
policy provides payment rules for services, in this case CHI services
furnished by CHWs or other types of auxiliary personnel who may or may
not be working in conjunction with a CBO. Above, we have finalized our
policy for CHI services and if a national accreditation program trains
or certifies and meets our requirements which includes applicable State
requirements, then those auxiliary personnel would
[[Page 78929]]
meet requirements to provide CHI services (assuming all other billing
requirements are met).
In our proposed rule, we proposed to require that time spent
furnishing CHI services for purposes of billing HCPCS codes G0019 and
G0022 must be documented in the patient's medical record in its
relationship to the SDOH need(s) they are intended to address and the
clinical problem(s) they are intended to help resolve. The activities
performed by the auxiliary personnel would be described in the medical
record, just as all clinical care is documented in the medical record.
We proposed to require the SDOH need(s) to be recorded in the patient's
medical record, and for data standardization purposes, stated that
practitioners would be encouraged to record the associated ICD-10 Z-
code (Z55-Z65) in the medical record and on the claim.
Since CHI services are community-based and involve connecting the
patient with local resources in their community, and are highly
personalized, for example, hearing and understanding a patient's life
story and culture, we believe that most of the elements of CHI services
would involve direct contact between the auxiliary personnel and the
patient, and that a substantial portion would be in-person, but
recognized that a portion might be performed via two-way audio. We
sought to confirm our understanding of where and how these services
would be typically provided (for example, in-person, audio-video, two-
way audio).
We solicited public comment regarding whether we should require
patient consent for CHI services. For care management services that
could generally be performed without any direct patient contact, we
require advance patient consent to receive the services as a
prerequisite to furnishing and billing the services, to avoid patients
receiving bills for cost sharing that they might not be expecting to
receive. For example, a patient might receive chronic care management
services comprised of practitioners coordinating care with each other
and reviewing or exchanging medical records between visits in ways that
do not require involving the patient directly. As we have frequently
discussed in prior rulemaking for care management services (for
example, at 81 FR 80240), we do not have statutory authority to waive
cost sharing for care management or other services. Rather, cost
sharing remains applicable except as specified by statute such as for
certain preventive services. In recent years, we have required advance
documented patient consent to receive most care management services as
a condition of the practitioner billing those services, to avoid a
situation where the patient is surprised to receive a bill for the
associated cost sharing. These consent requirements include informing
the patient about applicable cost sharing, the right to discontinue
services, and, where applicable, the limitation that payment is made
for the service to only one practitioner per month. We have heard from
interested parties over time that requiring advance patient consent is
an administrative burden and may pose a barrier to receipt of needed
services. We did not propose to require consent for CHI services, since
we believe these services typically would involve direct patient
contact, and largely be provided in-person. However, we stated that if
we heard from public commenters that CHI services would frequently not
involve direct contact with the patient, or could extend for periods of
time for which the patient might not be expecting to incur cost sharing
obligations (such as multiple months), we would consider requiring
patient consent to receive CHI services. We solicited comment regarding
whether we should require patient consent for CHI services. The
following is a summary of the comments we received and our responses.
Comment: Commenters confirmed that CHI services would most likely
occur both in-person and virtually (via audio-video or via two-way
audio) but noted that evidence shows that all services should include
some in-person interaction. As a result, a few commenters requested
that CMS provide a higher payment for services when they are delivered
in person to incentivize these types of interactions. Additionally, one
commenter recommended at least one in-person interaction each month,
unless the patient is in an area designated as rural, frontier, tribal,
or a geographically isolated territory.
Response: We acknowledge the commenters' suggestion that CHI
services would be available either in person, virtually, or a mix of
both. However, we continue to believe that most of the elements of CHI
services would involve direct contact between the auxiliary personnel
and the patient. Thus, we do not plan to provide a higher payment for
services when they are delivered in person, and we do not believe that
we need to incentivize in-person interactions. We hope to engage with
practitioners and other interested parties to inform any refinements to
the services through future rulemaking, as our collective experience
with these services grows.
Comment: Most commenters stated that patient consent should be
obtained prior to initiating services for CHI, so the beneficiary can
be counseled on the services being provided, in addition to potential
co-insurance and/or cost sharing requirements. A few commenters stated
that a patient should be allowed to give their consent verbally,
documented in the medical record, that the auxiliary personnel may
obtain consent, or virtually. Lastly, another commenter stated that
including the CHW in the CHI initiating visit with the practitioner as
part of the patient care team would avoid complications with consent
since the patient's approval would be provided during the initial
visit. The commenters stated that, considering that a variety of
factors may prevent a patient from returning to the clinic, it is
imperative that the CHW is introduced during the initial visit.
Comment: A few commenters disagreed consent should be required for
several reasons. One commenter expressed that consent should not be
required for CHI services because often times, patients do not
understand CHI services at the time presented, therefore discussing
consent would be difficult especially when there may be a lack of
understanding or if there are literacy, language, culture and learning
difficulties. Requiring consent is especially challenging given the
short time spent with the practitioner, especially during long
appointments where there are interpreter needs. Commenters generally
agreed that if consent will be required, they ask CMS to consider
verbal consent or consent as part of the annual consent for treatment.
Response: Having reviewed the public comments, we are persuaded by
the opinions of the commenters that we should require consent. CHI
services may not necessarily be in person, could be provided over many
months, and the patient would not necessarily expect to incur cost
sharing.
Comment: We received comments recommending on how consent should be
obtained. Commenters recommended that we not require consent to
obtained in person. Commenters stated that there may be circumstances
where it may not be possible to obtain consent during the initiating
visit. Commenters recommended that we not require written consent but
rather allow the patient to provide a verbal consent.
Response: After considering public comments we agree with
commenters that in order to reduce administrative burden that written
or verbal consent may be obtained as long as it is documented in the
medical record.
[[Page 78930]]
Comment: Several commenters asked about who would obtain consent.
Commenters asked CMS if consent could be obtained by auxiliary
personnel.
Response: While we believe it would be best for the billing
practitioner to obtain consent, we agree with the commenters that we
should allow auxiliary personnel to obtain the consent and that is what
we are finalizing. As part of the consent process, it must be explained
to the patient that cost sharing will apply and that only one
practitioner per month can bill the services. Consent only has to be
obtained once (rather than annually) and in cases where there is a
change in the billing practitioner, a new patient consent would be
required.
In summary, after consideration of public comments, we are
finalizing that patient consent is required in advance of providing CHI
services, but may be obtained either in writing or verbally, so long as
the consent is documented in the patient's medical record. We are also
finalizing that consent for CHI services may be obtained by auxiliary
personnel and must be obtained if there is a change in the billing
practitioner. The consent process must include explaining to the
patient that cost sharing applies and that only one practitioner may
furnish and bill the services in a given month.
In the proposed rule, we proposed that a billing practitioner may
arrange to have CHI services provided by auxiliary personnel who are
external to, and under contract with, the practitioner or their
practice, such as through a community-based organization (CBO) that
employs CHWs, if all of the ``incident to'' and other requirements and
conditions for payment of CHI services are met. Although we proposed to
allow CHI services to be performed by auxiliary personnel under a
contract with a third party, we stated, as we have in our regulations
for current care management services, that there must be sufficient
clinical integration between the third party and the billing
practitioner in order for the services to be fully provided, and the
connection between the patient, auxiliary personnel, and the billing
practitioner must be maintained. As we discussed in a similar context
for other care management services in the CY 2017 PFS final rule, if
there was little oversight by the billing practitioner or a lack of
clinical integration between a third party providing the services and
the billing practitioner, we did not believe services, as we proposed
to define them, could be fully performed; and therefore, in such cases,
services should not be billed (see 81 FR 80249). We stated that we
would expect the auxiliary personnel performing the CHI services to
communicate regularly with the billing practitioner to ensure that CHI
services are appropriately documented in the medical record, and to
continue to involve the billing practitioner in evaluating the
continuing need for CHI services to address the SDOH need(s) that limit
the practitioner's ability to diagnose and treat the problem(s)
addressed in the initiating visit.
As noted in the CY 2023 PFS final rule (87 FR 69790) and explained
in the CY 2023 PFS proposed rule (87 FR 46102), when we refer to
community-based organizations, we mean public or private not-for-profit
entities that provide specific services to the community or targeted
populations in the community to address the health and social needs of
those populations. They may include community-action agencies, housing
agencies, area agencies on aging, centers for independent living, aging
and disability resource centers or other non-profits that apply for
grants or contract with healthcare entities to perform social services.
As described earlier in this section, 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 services. We understood that many CBOs
provide social services and do other work that is beyond the scope of
CHI services, but we believed they are well-positioned to develop
relationships with practitioners for providing reasonable and necessary
CHI services.
Because we were concerned about potential fragmentation that could
occur in addressing specific SDOH, we proposed that only one
practitioner per beneficiary per calendar month could bill for CHI
services. This would allow the patient to have a single point of
contact for all their CHI services during a given month.
We proposed that the practitioner could separately bill for other
care management services during the same month as CHI services, if time
and effort are not counted more than once, requirements to bill the
other care management service are met, and the services are medically
reasonable and necessary.
We proposed that CHI services could not be billed while the patient
is under a home health plan of care under Medicare Part B, since we
believed there would be significant overlap between services furnished
under a home health plan of care and CHI services, particularly in the
home health services referred to as ``medical social services,'' and in
comprehensive care coordination. For example, medical social services
can be furnished to the patient's family member or caregiver on a
short-term basis when the home health agency (HHAs) can demonstrate
that a brief intervention by a medical social worker is necessary to
remove a clear and direct impediment to the effective treatment of the
patient's medical condition or to the patient's rate of recovery.
Additionally, the home health agency (HHA) conditions of participation
require that HHAs coordinate all aspects of the beneficiary's care
while under a home health plan of care, such as integrating services,
whether provided directly or under arrangement, to assure the
identification of patient needs and factors that could affect patient
safety and treatment effectiveness and the coordination of care
provided by all disciplines; and involvement of the patient,
representative (if any), and caregiver(s), as appropriate, in the
coordination of care activities.
Also, we noted that when Medicare and Medicaid cover the same
services for patients eligible for both programs, Medicare generally is
the primary payer in accordance with section 1902(a)(25) of the Act.
Based on the specificity of the coding for our proposal, we do not
expect that CHI services will neatly overlap with any other coverage
for patients who are dually eligible for Medicare and Medicaid.
However, we solicited public comment regarding whether States typically
cover services similar to CHI under their Medicaid programs, and
whether such coverage would be duplicative of the CHI service codes. We
also solicited comment on whether there are other service elements not
included in the proposed CHI service codes that should be included, or
are important in addressing unmet SDOH need(s) that affect the
diagnosis or treatment of medical problems, where CMS should consider
coding and payment in the future.
The following is a summary of the comments we received and our
responses.
[[Page 78931]]
Comment: Many commenters requested that CMS reconsider the
exclusion of home health patients and urged CMS to allow for concurrent
billing of CHI services and skilled home health plan of care because it
is well established that the limited social work component of a home
health plan of care is not adequate to address complex health related
social needs and does not include the same intensity of support that is
outlined in the CHI services benefit. Commenters expressed that not
allowing CHI services to be billed for patients who are receiving the
home health benefit and have a home health plan of care could result in
patients losing the services provided by CHWs to meet their needs
related to social determinants of health, healthcare translation, and
patient advocacy. Commenters noted that home health services typically
extend for 60 days or more, and if the patient is currently receiving
home health benefits it would put the patient in a position of choosing
between two important services, potentially negatively impacting health
outcomes.
Response: We acknowledge the commenter's assertions that a home
health plan of care is inadequate to address complex health-related
social needs and does not include the same intensity of support that is
outlined in the CHI services benefit. However, we believe that policy
and payments accounted for under the home health prospective payment
system already reflect much of the services described by the CHI codes,
such that there would be significant overlap between CHI services and
services furnished under a home health plan of care. Specifically, when
a beneficiary is under a home health plan of care, medical social
services are a covered home health service. Services of these
professionals which may be covered include, but are not limited to:
assessment of the social and emotional factors related to the patient's
illness, need for care, response to treatment and adjustment to care;
assessment of the relationship of the patient's medical and nursing
requirements to the patient's home situation, financial resources and
availability of community resources; appropriate action to obtain
available community resources to assist in resolving the patient's
problem; and counseling services that are required by the patient and
medical social services for the patient's family member or caregiver on
a short-term basis.
Comment: Some commenters stated that most State Medicaid programs
do not directly cover CHI services at this time, and the States that do
have Medicaid billing codes for CHW services have reimbursement rates
that are insufficient and unsustainable. Other commenters stated that
authorizing Medicare payments for the CHI services would be
complementary to services currently provided under Medicaid.
Additionally, commenters stated that the Medicare proposal takes a more
effective holistic approach to identify and remedy all social
determinants of health impacting a beneficiary's medical condition
compared to Medicaid.
Response: We thank the commenters for their feedback. The CHI
services are meant to resolve those specific concerns to facilitate the
patient's medical care, which would distinguish CHI from other social
services and programs that may be available through Medicaid State
plans or other State or community programs.
After consideration of public comments, we are finalizing as
proposed that a billing practitioner may arrange to have CHI services
provided by auxiliary personnel who are external to, and under contract
with, the practitioner or their practice, such as through a community-
based organization (CBO) that employs CHWs, if all of the ``incident
to'' and other requirements and conditions for payment of CHI services
are met, and that there must be sufficient clinical integration between
the third party and the billing practitioner in order for the services
to be fully provided. We are also finalizing as proposed that CHI
services could not be billed while the patient is under a home health
plan of care under Medicare Part B. We want to emphasize the idea that
CHI is covered and paid under the Medicare program when there are SDOH
needs that are interfering with the billing clinician's diagnosis and
treatment of the patient. These services are meant to resolve those
specific concerns to facilitate the patient's medical care, which would
distinguish CHI from other social services and programs that may be
available through Medicaid State plans or other State or community
programs.
c. CHI Services Valuation
For HCPCS code G0019, we proposed a work RVU of 1.00 based on a
crosswalk to CPT code 99490 (Chronic care management services with the
following required elements: multiple (two or more) chronic conditions
expected to last at least 12 months, or until the death of the patient,
chronic conditions that place the patient at significant risk of death,
acute exacerbation/decompensation, or functional decline, comprehensive
care plan established, implemented, revised, or monitored; first 20
minutes of clinical staff time directed by a physician or other
qualified health care professional, per calendar month) as we believed
these values most accurately reflected the resource costs incurred when
the billing practitioner furnishes CHI services. CPT code 99490 has an
intraservice time of 25 minutes and the work is of similar intensity to
our proposed HCPCS code G0019. Therefore, we proposed a work time of 25
minutes for HCPCS code G0019, based on this same crosswalk to CPT code
99490. We also proposed to use this crosswalk to establish the direct
PE inputs for HCPCS code G0019.
For HCPCS code G0022, we proposed a crosswalk to the work RVU and
direct PE inputs associated with CPT code 99439 (Chronic care
management services with the following required elements: multiple (two
or more) chronic conditions expected to last at least 12 months, or
until the death of the patient, chronic conditions that place the
patient at significant risk of death, acute exacerbation/
decompensation, or functional decline, comprehensive care plan
established, implemented, revised, or monitored; each additional 20
minutes of clinical staff time directed by a physician or other
qualified health care professional, per calendar month (List separately
in addition to code for primary procedure)) as we believed these values
reflected the resource costs incurred when the billing practitioner
furnishes CHI services. Therefore, we proposed a work RVU of 0.70 and a
work time of 20 minutes for HCPCS code G0022.
We received public comments on valuation. The following is a
summary of the comments we received and our responses.
Comment: While most commenters were generally supportive of our
proposed crosswalks and valuations for HCPCS codes G0019 and G0022, and
our proposed work RVU of 1.00 and a work time of 25 minutes based on a
crosswalk to CPT code 99490 for G0019 and proposed a work RVU of 0.70
and a work time of 20 minutes for HCPCS code G0022 based on a crosswalk
to CPT code 99439. While some commenters agreed with HCPCS code G0019
and the crosswalk to CPT code 99490, they disagreed with the suggested
time for the service and suggested that every subsequent 20 minutes of
CHI services up to 60 minutes should have a separate HCPCS code that
has an equivalent RVU crosswalk to CPT code 99490. Then, these
commenters would agree with the RVU for HCPCS code G0022, as long as
[[Page 78932]]
there is recognition that the first hour can be billed in 20-minute
increments up to a total of 60 minutes.
Additionally, several commenters noted that the chronic care
management services codes are billed in 20-minute increments and
questioned whether every subsequent twenty minutes of CHI, up to 60
minutes, should have a separate HCPCS code that has an equivalent RVU
crosswalk to CPT codes 99490 and 99439, up to 60 minutes per calendar
month.
Response: We thank the commenters for their feedback. It is our
understanding that appropriately addressing patient needs that require
CHI services would take longer than 20 minutes per month, and so to
promote the comprehensiveness and integrity of the service elements we
are finalizing as proposed for these services. We will monitor the
utilization of CHI services and will consider changes over time for
future rulemaking.
Comment: A few commenters were not in support of the proposed
valuations and encouraged CMS to reevaluate as there is a significant
amount of work the CHW provides to the patient, whether for SDOH
support or coordination of care for chronic conditions, wellness, and
prevention, educating the patient, and building patient self-advocacy
skills. Another commenter requested the work RVU for HCPCS code G0019
be increased. An additional commenter suggested that the work RVU value
of the 60-minute monthly CHI service should be equivalent to a CPT code
99214 E/M visit and the additional 30-minutes CHI service should be
equivalent to a CPT code 99213 E/M visit.
Commenters recommended that CMS submit the CHI services codes and
the PIN services codes to the RUC for their review.
Response: We thank commenters for their feedback and recommendation
to have these new G codes for CHI services be reviewed by the RUC.
While the RUC does not typically review G codes created by CMS, these
codes could be potentially reviewed in a future rule cycle if the RUC
chooses to do so. We remind readers that the RUC is an independent
organization not administered by CMS that typically decides which codes
will be reviewed based on its own internal criteria.
After consideration of public comments, we are finalizing the
valuation of these codes as proposed. We will monitor the utilization
of these new codes and consider any changes in possible future
rulemaking.
d. Social Determinants of Health (SDOH)--Proposal To Establish a Stand-
Alone G Code
i. Background
As previously discussed, there is increasing recognition within the
health care system of the need to take SDOH into account when providing
health care services, given that it is estimated \15\ that around 50
percent of an individual's health is directly related to SDOH. Healthy
People 2030 define the broad groups of SDOH as: economic stability,
education access and quality, healthcare access and quality,
neighborhood and built environment, and social and community context,
which include factors like housing, food and nutrition access, and
transportation needs. Many Federal agencies are also developing
policies to better address the impact SDOH have on patients, in support
of HHS's Strategic Approach to Addressing Social Determinants of Health
to Advance Health Equity,\16\ as well as the CMS Framework for Health
Equity.\17\
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\15\ https://aspe.hhs.gov/sites/default/files/documents/e2b650cd64cf84aae8ff0fae7474af82/SDOH-Evidence-Review.pdf.
\16\ https://aspe.hhs.gov/sites/default/files/documents/aabf48cbd391be21e5186eeae728ccd7/SDOH-Action-Plan-At-a-Glance.pdf.
\17\ https://www.cms.gov/files/document/cms-framework-health-equity-2022.pdf.
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ii. SDOH Risk Assessment Code
Over the past several years, we have worked to develop payment
mechanisms under the PFS to improve the accuracy of valuation and
payment for the services furnished by physicians and other health care
professionals, especially in the context of evolving models of care.
Section 1862(a)(1)(A) of the Act generally excludes from coverage
services that are not reasonable and necessary for the diagnosis or
treatment of illness or injury or to improve the functioning of a
malformed body member. Practitioners across specialties have opined and
recognized the importance of SDOH on the health care provided to their
patients, including by recommending the assessment of SDOH through
position or discussion papers,18 19 20 organizational
strategic plans,\21\ and provider training modules.\22\ In the proposed
rule, we outlined how the practice of medicine currently includes
assessment of SDOH in taking patient histories, assessing patient risk,
and informing medical decision making, diagnosis, care and treatment.
The taking of a social history is generally performed by physicians and
practitioners in support of patient-centered care to better understand
and help address relevant problems that are impacting medically
necessary care. We believe the resources involved in these activities
are not appropriately reflected in current coding and payment policies.
As such, we proposed to establish a code to separately identify and
value a SDOH risk assessment that is furnished in conjunction with an
E/M visit.
---------------------------------------------------------------------------
\18\ https://www.aafp.org/about/policies/all/social-determinants-health-family-medicine-position-paper.html.
\19\ https://doi.org/10.7326/M17-2441.
\20\ https://nam.edu/social-determinants-of-health-201-for-health-care-plan-do-study-act/.
\21\ https://www.ama-assn.org/system/files/2021-05/ama-equity-strategic-plan.pdf.
\22\ https://edhub.ama-assn.org/steps-forward/module/2702762.
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We proposed a new stand-alone G code, now assigned as HCPCS code
G0136, Administration of a standardized, evidence-based Social
Determinants of Health Risk Assessment, 5-15 minutes, not more often
than every 6 months. 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 proposed HCPCS code
G0136 to identify and value the work involved in the administering a
SDOH risk assessment as part of a comprehensive social history when
medically reasonable and necessary in relation to an E/M visit. SDOH
risk assessment through a standardized, evidence-based tool can more
effectively and consistently identify unmet SDOH needs and enable
comparisons across populations. For example, through administration of
the SDOH risk assessment for a patient presenting for diabetes
management, a practitioner might discover that a patient's living
situation does not permit reliable access to electricity, impacting the
patient's ability to keep insulin refrigerated. The practitioner may
then prescribe a type of insulin that remains stable at room
temperature or consider oral medication instead. In this example, the
practitioner could furnish an SDOH risk assessment in conjunction with
the E/M visit to gain a more thorough understanding of the patient's
full social history and to determine whether other SDOH needs are also
impacting medically necessary care.
We further proposed that the SDOH risk assessment must be furnished
by the practitioner on the same date they furnish an E/M visit, as the
SDOH assessment would be reasonable and necessary when used to inform
the patient's diagnosis, and treatment plan established during the
visit. Required elements would include:
[[Page 78933]]
Administration of a standardized, evidence-based \23\ SDOH
risk assessment tool that has been tested and validated through
research, and includes the domains of food insecurity, housing
insecurity, transportation needs, and utility difficulties.
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\23\ https://health.gov/healthypeople/tools-action/browse-evidence-based-resources/types-evidence-based-resources.
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++ Billing practitioners may choose to assess for additional
domains beyond those listed above if there are other prevalent or
culturally salient social determinants in the community being treated
by the practitioner.
Possible evidence-based tools include the CMS Accountable Health
Communities (AHC) \24\ tool, the Protocol for Responding to & Assessing
Patients' Assets, Risks & Experiences (PRAPARE) \25\ tool, and
instruments identified for Medicare Advantage Special Needs Population
Health Risk Assessment.\26\
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\24\ https://innovation.cms.gov/files/worksheets/ahcm-screeningtool.pdf.
\25\ https://www.nachc.org/research-and-data/prapare/.
\26\ CMS-10825.
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Given the multifaceted nature of unmet SDOH needs appropriate
follow-up is critical for mitigating the effects of the identified,
unmet SDOH needs on a person's health. An SDOH risk assessment without
appropriate follow-up for identified needs would serve little purpose.
As such, CMS solicited comment on whether we should require as a
condition of payment for SDOH risk assessment that the billing
practitioner also have the capacity to furnish CHI, PIN, or other care
management services, or have partnerships with community-based
organizations (CBO) to address identified SDOH needs.
The SDOH needs identified through the risk assessment must be
documented in the medical record and may be documented using a set of
ICD-10-CM codes known as ``Z codes'' \27\ (Z55-Z65) which are used to
document SDOH data to facilitate high-quality communication between
providers. We proposed a duration of 5-15 minutes for HCPCS code G0136
for the administration of an SDOH risk assessment tool, billed no more
often than once every 6 months. We proposed to limit the SDOH
assessment service to once every six months, as we believe there are
generally not significant, measurable changes to health outcomes
impacted by a patient's SDOH in intervals shorter than 6 months.
---------------------------------------------------------------------------
\27\ https://www.cms.gov/files/document/z-codes-data-highlight.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: Commenters were overall supportive of our definition of
SDOH. We received several comments requesting that CMS change the name
to social drivers of health, drivers of health, or health-related
social needs. Many of these commenters noted that other CMS programs
use the term social drivers of health and requested that CMS use
consistent naming conventions. Many commenters agreed that our proposal
aligns with ongoing efforts to improve health equity and applauded our
proposal for a new code. Other commenters discussed work that is
already occurring in performing SDOH risk assessments and cited the
benefits of adding payment in the PFS for these services, as they are
currently under- or unpaid. Several commenters from rural and
underserved areas noted that funding is scarce for resources like
community-based organizations, and they were hopeful this code would
increase funding and therefore access to such services.
One commenter suggested that this service was duplicative as the E/
M coding structure allows practitioners to report a higher code to
capture increased intensity services, such as when SDOH considerations
are present. A few commenters strongly opposed the proposal, expressing
concern that our proposal would divert dollars from medical care and
would impose surveillance data gathering, which they considered
intrusive on patients. A few other commenters recommended that the
proposal should not be finalized and should be further studied before
implementation. Another commenter recommended that we delay
implementation until a more detailed analysis is available on the use
of SDOH to improve patient outcomes. Several commenters recommended
this code be exempted from budget neutrality, and a few other
commenters suggested that CMS waive cost-sharing for this service.
Response: We note that there are many definitions and names for
similar assessments, and we share the desire to align naming
conventions across programs, especially within CMS. However, we note
that there is not yet a universally accepted term for these types of
factors. Many definitions have slight differences in their intent or
meaning, which complicates standardization. SDOH is defined by the
Current Procedural Terms (CPT) coding guidelines, which is why we used
this term in the proposal. We will consider whether there could be
greater alignment in terminology across CMS in the future. We
acknowledge that the E/M coding structure does allow for a higher level
of Medical Decision-Making when taking things like SDOH into
consideration. For this reason, we continue to believe that this code
represents work that is currently not accounted for.
With respect to budget neutrality, we remind commenters that
section 1848(c)(2)(B)(ii)(II) of the Act requires that increases or
decreases in RVUs may not cause the amount of Medicare Part B
expenditures for the year to differ by more than $20 million from what
expenditures would have been in the absence of these changes. If this
threshold is exceeded, we must make adjustments to preserve budget
neutrality. There is no statutory exception available for the SDOH risk
assessment, so the expected spending associated with these services
must be included in the CY 2024 BN adjustment. As we have frequently
discussed in prior rulemaking for care management services (for
example, at 81 FR 80240), we do not have authority to waive cost
sharing for care management or other services except as specified in
statute, such as for certain preventive services. Rather, cost sharing
remains applicable for the proposed SDOH risk assessment and other care
management services. We note that the beneficiaries likely to benefit
the most from this risk assessment may qualify or already be enrolled
in programs to reduce or eliminate cost sharing, such as Medicaid or
other supplemental insurances. We do not agree with commenters who
stated this type of information will impose surveillance data gathering
in a way that is intrusive to patients. We acknowledge that the
information collected as part of an SDOH risk assessment could be
sensitive in nature, and we understand that discussing SDOH-related
topics may be perceived as intrusive to some beneficiaries. However, as
we discussed in the introduction, this information is already being
collected by practitioners in medical settings, as many across the
medical community agree that this type of information is important to
the health care patients receive. We are not proposing new forms of
data collection, but rather are seeking to acknowledge this work
through payment, which was supported by other commenters.
Comment: We received many comments related to the proposed
requirement that SDOH risk assessment be furnished the same date as an
E/M visit. Many commenters requested clarification on the same date
requirement, citing operational difficulty in performing the assessment
during the visit and requested that we
[[Page 78934]]
allow for the risk assessment to be performed 7-10 days prior to the
appointment, given that many practitioners utilize a ``pre-check-in''
system via an online portal. We also received many comments discussing
the furnishing of the SDOH risk assessment in conjunction with E/M
visits. Some commenters requested that clinical psychologists be
allowed to furnish SDOH risk assessment and specified that the SDOH
risk assessment should be billable with CPT code 90791 and HBAI codes
in addition to E/M visits, noting that patients with mental health
conditions often have unmet social needs and may not see another health
care practitioner routinely beyond a clinical psychologist. We received
many comments requesting clinical social workers be added explicitly to
the list of practitioners able to furnish SDOH risk assessments, citing
that assessment of SDOH needs falls within their competencies and
training. Other commenters recommended including all practitioners who
can bill Medicare directly, such as marriage and family therapists
(MFTs), mental health counselors (MHCs), and physical and occupational
therapists.
Response: We understand that many practitioners use online portals
for the collection of demographic and insurance information prior to
the visit for operational ease. However, we emphasize that this is a
SDOH risk assessment, not a screening. The SDOH risk assessment is
intended to be used when a practitioner has reason to believe there are
unmet SDOH needs that are interfering with the practitioner's diagnosis
and treatment of a condition or illness. As such, there are limited
scenarios in which we envision a practitioner would know ahead of a
visit that an SDOH risk assessment would be appropriate, such as a
patient who has a history of unmet SDOH needs, or the patient disclosed
such information before the visit. Examples could include the patient
requesting an appointment at a specific time or on a specific date due
to the limited availability of transportation to or from the visit, or
the patient requests a refill of refrigerated medication that went bad
when the electricity was terminated at their home. Given this, we do
not agree with commenters that it would be typically appropriate to
have a patient fill out an SDOH risk assessment 7-10 days in advance of
an appointment. We understand that in limited scenarios, such as
described above, a clinician may wish to get an SDOH risk assessment
during pre-check-in paperwork. We are also sensitive to commenters'
feedback about the operational difficulties in getting an SDOH risk
assessment during an associated appointment, especially in
circumstances discussed by the commenters where it is already part of
the check-in process practitioners have in place. We agree with
commenters that SDOH risk assessment is relevant to the diagnosis and
treatment of conditions furnished by practitioners such as clinical
psychologists for patients with behavioral health conditions. We do not
agree with commenters that all practitioners who can bill for Medicare
should qualify to perform the SDOH risk assessment under statute as
reasonable and necessary, as we believe that practitioners who can bill
E/M or similar behavioral health visits such as CPT code 90791 and HBAI
codes are best positioned to provide follow-up and ongoing assessment
in a longitudinal way. These codes are used by clinical psychologists
to diagnose and treat behavioral health conditions as analogous codes
to E/M services given State law and scope of practice. We acknowledge
that other practitioners such as clinical social workers may benefit
from an understanding of the patient's SDOH considerations to furnish
their services. However, we believe that this information should be
shared when possible or applicable with the care team by the furnishing
practitioner of the associated E/M or behavioral health visit.
After consideration of the public comments, we are finalizing the
title, ``Social Determinants of Health'' (SDOH) risk assessment for
HCPCS code G0136 as proposed. As discussed in response to public
comments, this is to align with the language used by CPT. Given that we
are focused on payment for physicians' services, most of which are
billed using CPT codes, we believe that aligning our terminology with
CPT makes the most sense. We are not finalizing the requirement that
the SDOH risk assessment must be performed on the same date as the
associated E/M or behavioral health visit (such as CPT code 90791 or
HBAI codes), for the operational ease of practitioners. This is also in
alignment with when HCPCS code G0136 is performed in conjunction with
an AWV, as the AWV may be split over two visits (see section III.S. of
this final rule for this discussion). We continue to believe that in
most cases, HCPCS code G0136 would not be performed in advance of the
associated E/M or behavioral health visit. We reiterate that the SDOH
risk assessment code, HCPCS code G0136, when performed in conjunction
with an E/M or behavioral health visit is not designed to be a
screening, but rather tied to one or more known or suspected SDOH needs
that may interfere with the practitioners' diagnosis or treatment of
the patient.
Regarding the types of associated visits that can be performed with
HCPCS code G0136, our aim is to allow behavioral health practitioners
to furnish the SDOH risk assessment in conjunction with the behavioral
health office visits they use to diagnose and treat mental illness and
substance use disorders. We are finalizing that in addition to an
outpatient E/M visit (other than a level 1 visit by clinical staff) as
proposed, SDOH risk assessment can also be furnished with CPT code
90791 (Psychiatric diagnostic evaluation) and the Health Behavior
Assessment and Intervention (HBAI) services, described by CPT codes
96156, 96158, 96159, 96164, 96165, 96167, and 96168. We are also
finalizing that HCPCS code G0136 may also be performed in conjunction
with an Annual Wellness Visit. This is discussed in more detail in
section III.S. of this final rule.
Comment: We received several comments requesting clarification on
the types of settings in which a SDOH risk assessment can occur, and
several commenters asked whether this service could be furnished in the
emergency department, observation unit, or during the perioperative
period. These commenters noted that beneficiaries with unmet social
needs are often seen more frequently in the emergency department
setting, and these beneficiaries may lack access to primary care. Other
commenters asked whether HCPCS code G0136 could be performed in
conjunction with the E/M that is part of TCM. These commenters
discussed that a patient's SDOH needs may have changed during the time
of a hospitalization, citing examples such as new financial or housing
instability due to being out of work for a prolonged time. Another
commenter discussed that if a patient was going to be going home in a
wheelchair for the first time, they may have new transportation issues
if they do not have access to wheelchair-accessible transportation.
Commenters also asked about the use of HCPCS code G0136 in conjunction
with hospital discharge visits.
Response: We thank the commenters for their feedback. We recognize
that unmet SDOH needs may be relevant to the care received in facility
settings such as emergency departments and observation units, and it
may be appropriate for practitioners to adjust the treatment plan in
these settings
[[Page 78935]]
based on known SDOH needs. When we created HCPCS code G0136, we
envisioned it being used in outpatient office settings, in which a
patient is interacting with a practitioner with whom they have a long-
standing care relationship. We acknowledge that patients may have long-
standing care relationships with practitioners they see in settings
such as during the operative period, but we believe this to be
atypical. Additionally, we are generally wary of paying for SDOH risk
assessment upon every interaction with the health care system, since
this could be burdensome for the patient and have less utility if the
unmet SDOH needs are never addressed or followed up with in a
longitudinal way. We agree with commenters that it makes sense to
permit the use of HCPCS code G0136 in conjunction with hospital
discharge visits. We note that this is consistent with other CMS
policies since SDOH are present in the Hospital Inpatient Quality
Reporting Program measures, and that SDOH have been identified as key
factors related to safe discharge planning. Even so, our expectation is
that patients that have identified unmet SDOH needs will continue to
follow up as an outpatient either through TCM or E/M visits.
We also believe that SDOH risk assessment is especially important
during transitions in care, which was pointed out by commenters when
asking if hospital discharges and TCM would count as an applicable
associated visit. For TCM visits, we clarify that individuals who are
discharged from a hospital, observation unit, or post-acute care, would
also be able to receive the SDOH risk assessment during the TCM E/M
visit, to ensure that SDOH needs have been taken into consideration as
the patient transitioned back into the community. The use of HCPCS code
G1036 in conjunction with the TCM E/M visit has the added benefit that
it is likely that the practitioner furnishing TCM will be following the
patient longitudinally in an outpatient setting and can assess for
changes in unmet SDOH needs over time.
After consideration of public comments, we are finalizing that
HCPCS code G0136 may be furnished with hospital discharge visits, to
remain consistent with other CMS policies promoting assessment of SDOH
as an indicator of quality care and to promote safe discharge planning.
We are also finalizing that HCPCS code G0136 can be billed in
outpatient settings. We are interested in learning more about the ideal
settings for HCPCS code G0136 as we work with interested parties about
how HCPCS code G0136 is used, and we will continue to examine this
issue in future rulemaking.
Comment: Commenters were generally supportive of the proposed
requirements for the use of a standardized, evidence-based SDOH risk
assessment tool. Commenters generally appreciated the operational
flexibility of CMS not requiring a specific tool, especially if they
are already utilizing an SDOH risk assessment tool. A few commenters
requested that CMS specify one specific tool or publish a list of
approved tools to improve standardization and interoperability. Other
commenters requested that CMS clarify that the list of tools is not
exhaustive, and tools beyond those listed can be used if they meet the
criteria. A few commenters requested that CMS only accept tools that
meet the Office of the National Coordinator (ONC) for Health
Information IT's interoperability standards. Others recommended that
CMS limit to a specific list of industry-approved tools. Several
commenters also noted that some quality standards allow for
practitioners to combine questions from validated instruments and
suggested CMS adopt similar standards.
Response: We agree with commenters that interoperability and
standardization are important, and we understand that specifying a list
of tools or limiting to one tool would work towards those aims. As
such, we note that in the proposed rule, we discussed that possible
evidence-based tools include the CMS Accountable Health Communities
tool, the Protocol for Responding to & Assessing Patients' Assets,
Risks & Experiences (PRAPARE) tool, and instruments identified for
Medicare Advantage Special Needs Population Health Risk Assessment.
However, we are also interested in ensuring that practitioners are able
to select tools and questions beyond the specified tools, that are
relevant to the beneficiaries they serve. There is not a national
consensus around one specific tool for the assessment of SDOH needs.
Currently, practitioners and researchers choose the tool (or tools)
that fit their needs, and we have no desire to limit or restrict this
current work, so long as it meets the parameters specified in this
rule. We remain committed to finding a balance between the benefits of
allowing maximum operational flexibility and encouraging evidence-based
standardization and interoperability.
Comment: Commenters were in favor of requiring the use of a tool
which includes the specified domains of food insecurity, housing
insecurity, transportation needs, and utility difficulties. Several
commenters discussed food insecurity as a foundational or key domain to
be assessed, citing the dietary aspects to the treatment of conditions
such as diabetes and hypertension. A few commenters expressed
appreciation for the option to add additional domains, as relevant to
their patient population. Several commenters also requested that the
tool used be required to include the domain of interpersonal safety,
citing CMS quality programs that require inclusion of interpersonal
safety, and evidence that this is an important SDOH need. Another
commenter recommended CMS explore including domains related to climate
change.
Response: We agree with commenters who discussed the importance of
food insecurity, and we believe the inclusion of this domain is in line
with efforts across the government to tackle food insecurity, such as
the White House Conference and Strategy on Hunger, Nutrition, and
Health.\28\ We agree that interpersonal safety is an important
dimension of potential SDOH needs, and we also recognize the potential
difficulty of collecting, storing, and acting on such sensitive
information in a clinical setting. We note that practitioners may add
additional domains if they believe those domains are relevant to their
patient population, in which case they could utilize a tool that
includes interpersonal safety.
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\28\ https://health.gov/our-work/nutrition-physical-activity/white-house-conference-hunger-nutrition-and-health.
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After consideration of public comments, we are finalizing as
proposed, that any standardized, evidence-based SDOH risk assessment
tool that has been tested and validated through research, may be used
to conduct the SDOH risk assessment. The tool must include the domains
of food insecurity, housing insecurity, transportation needs, and
utility difficulties.
We solicited comments regarding whether we should require as a
condition of payment for SDOH risk assessment, that the billing
practitioner also have the capacity to furnish CHI, PIN, or other care
management services, or have partnerships with community-based
organizations (CBO) to address identified SDOH needs.
Comment: Commenters were mixed on this potential required condition
of payment. Most commenters agreed with our assessment that follow-up
is critical to mitigating the impacts of unmet SDOH needs. However,
commenters differed on how CMS should potentially handle this. Many
commenters agreed
[[Page 78936]]
that furnishing CHI, PIN, other care management services, or having
partnerships with CBOs would address identified SDOH needs and was a
reasonable requirement to furnish this service. Some commenters stated
that we should only finalize this proposal with some requirement for
follow-up. A few commenters stated that there is no need to perform an
SDOH risk assessment if the practitioner does not have the ability to
provide adequate follow up in place. Some commenters agreed that
ideally, a practitioner would have an established relationship with a
CBO, but noted that in some areas, particularly those that are rural
and underserved, there are a limited supply of CBOs to address SDOH
needs. Other commenters asked us to clarify if we were expecting
practitioners to solve long-standing barriers for patients, or if we
were focused on immediate actions that practitioners could take based
on a positive risk assessment. A few other commenters agreed with the
importance of follow-up but noted that this requirement is too
burdensome for practitioners to have in place before they understand
the SDOH needs of their patients and the communities in which their
patients live.
Response: We continue to believe that follow-up or referral is an
important aspect of following up on findings from an SDOH risk
assessment. We acknowledge that practitioners may not be ideally suited
to solve long-standing SDOH concerns, but we also agree with commenters
that follow up or referral after an SDOH risk assessment is an
important element to addressing the issues that impact a patient's
health and can help the patient connect with services and individuals
that can address more of the patient's SDOH needs. We are clarifying
that we are focused on SDOH risk assessment to identify issues that
impact the practitioner's ability to diagnose and treat the patient. We
thank the commenters for noting supply issues with CBOs in some places,
and we understand that this will likely be an ongoing issue for some
time, particularly in rural and underserved areas as many practitioners
do not currently have relationships with CBOs. We are also sensitive to
the operational needs of practitioners who do not yet have these
resources in place, but who may wish to develop these relationships
with the advent of this new coding. We are attempting to strike a
balance between these two needs. We expect to monitor utilization of
these codes, and we leave open the opportunity to reevaluate this
decision on an ongoing basis.
Comment: Many commenters supported the use of the ICD-10-CM codes
known as Z codes (Z55-Z65) for documentation of SDOH data. A few
commenters recommended CMS require the use of Z codes for
standardization and interoperability across platforms. Other commenters
recommended CMS mention or require the utilization of other systems for
documenting social needs. Commenters who discussed the duration of 5-15
minutes agreed that this seemed appropriate.
Response: As stated previously, we understand and recognize the
importance of data standardization and interoperability. We are
requiring that the SDOH needs identified through the risk assessment be
documented in the medical record, and we are actively encouraging Z-
code reporting to improve our data and understanding of how SDOH affect
the patient populations enrolled in CMS programs. For example, recently
CMS identified that when the Z code for homelessness was encoded during
an inpatient admission, there is an increase in resource usage by the
hospital, and as such, CMS underwent rulemaking to incorporate the Z
code for homelessness as a comorbidity or complication that would
increase the severity level in the MS-DRG \29\ system.
---------------------------------------------------------------------------
\29\ 88 FR 58640.
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Comment: Many commenters discussed the proposed frequency
limitation of once per 6 months, requesting that CMS clarify if the
limitation was per beneficiary, or per practitioner per beneficiary.
Many commenters noted operational difficulty if the frequency
limitation was per beneficiary, as beneficiaries often have
practitioners across different health systems, and interoperability
constraints with EHRs would make it difficult to verify if the patient
had received an SDOH risk assessment in the last 6 months. Other
commenters noted that a new diagnosis may cause a rapid shift in SDOH
needs, with sudden onset of mobility and transportation difficulty, or
a disability that limited a beneficiary's ability to work. Many
commenters discussed alternative frequency limitations, understanding
that 6 months may be appropriate for those without previous SDOH needs,
but more frequent risk assessment may be necessary for those with a
history of unmet SDOH needs. Commenters also noted that the SDOH risk
assessment would be especially salient during care transitions such as
discharge from a facility such as a hospital or SNF, or a beneficiary
who was seen several times in the emergency department recently.
Response: We appreciate the commenters for their thoughtful and
thorough comments. We agree that with new services, the appropriate
frequency limitation is often difficult to ascertain. We also
appreciate the operational difficulty of knowing when a beneficiary
last received an SDOH risk assessment, given that many beneficiaries
seek care with several practitioners or in different health systems. We
acknowledge that SDOH needs may change quickly, especially in
beneficiaries with a history of unmet social needs. We also agree with
the comments discussing that care transitions are especially important
moments for potential SDOH risk assessment and note that the
Transitional Care Management (TCM) (CPT codes 99495 and 99496) are E/M
visits and qualify as an associated visit. We aim to strike a balance
between what is best for the patient and what is operationally best for
the practitioner, as well as considering the patient's cost sharing
responsibilities for each time HCPCS code G0136 is furnished separately
from the AWV. We also note that if a patient requires frequent SDOH
reassessments, this patient may benefit from CHI or PIN to manage these
concerns on an ongoing basis. We will continue to engage with
interested parties and may consider policy changes in future rulemaking
cycles based on our review of claims data or feedback from interested
parties.
In light of comments we received in response to the proposed rule,
we are not finalizing the requirement that the practitioner who
furnishes the SDOH risk assessment must also have the capacity to
furnish CHI, PIN, other care management services, or have partnerships
with CBOs. We do expect that the practitioner furnishing an SDOH risk
assessment would, at a minimum, refer the patient to relevant resources
and take into account the results of the assessment in their medical
decision making, or diagnosis and treatment plan for the visit.
We are finalizing as proposed that any SDOH need identified during
HCPCS code G0136 must be documented in the medical record. We are
clarifying that we are not requiring the use of the Z code for
documentation, though we are confirming that use of Z codes would be
appropriate to document SDOH needs in the medical record. We encourage
the use of Z codes across CMS programs to better understand the needs
of our beneficiaries. We are finalizing a limitation on payment for the
SDOH
[[Page 78937]]
risk assessment service of once every 6 months per practitioner per
beneficiary.
iii. Valuation for SDOH Risk Assessment (HCPCS Code G0136)
We proposed a direct crosswalk to HCPCS code G0444 (Screening for
depression in adults, 5-15 minutes), with a work RVU of 0.18, as we
believe this service reflects the resource costs associated when the
billing practitioner performs HCPCS code G0136. HCPCS code G0444 has an
intraservice time of 15 minutes, and the physician work is of similar
intensity to our proposed HCPCS code G0136. Therefore, we proposed a
work time of 15 minutes for HCPCS code G0136 based on this same
crosswalk to HCPCS code G0444. We also proposed to use this crosswalk
to establish the direct PE inputs for HCPCS code G0136.
We believe these services would largely involve direct patient
contact between the billing practitioner or billing practitioner's
auxiliary personnel and the patient through in-person interactions,
which could be conducted via telecommunications as appropriate.
Therefore, we proposed to add this code to the Medicare Telehealth
Services List to accommodate a scenario in which the practitioner (or
their auxiliary personnel incident to the practitioner's services)
completes the risk assessment in an interview format, if appropriate.
We believe it is important that when furnishing this service, all
communication with the patient be appropriate for the patient's
educational, developmental, and health literacy level, and be
culturally and linguistically appropriate. We solicited comment on
where and how these services would be typically provided, along with
other aspects of the SDOH assessment service.
We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: Commenters agreed with our proposed crosswalk to HCPCS
code G0444 for similar time, intensity, and direct PE inputs.
Commenters were overwhelmingly supportive of our proposal to add HCPCS
code G0136 to the Medicare Telehealth Services List. Commenters also
supported CMS' belief that all communication with the patient be
appropriate for the patient's educational, developmental, and health
literacy level, and be culturally and linguistically appropriate. A few
commenters noted that SDOH risk assessments are typically provided in
an outpatient setting on a tablet or paper document by auxiliary
personnel. A few commenters noted that they are performing routine SDOH
``screening'' at standard intervals, with one commenter noting they
screen patients at every visit. We also received a few comments
requesting that CMS provide more clarity on the intersection between
HCPCS code G0136 and PIN services. These commenters asked if HCPCS code
G0136 should be used to reassess when SDOH needs are present while the
patient is also receiving PIN services, or if SDOH reassessment can be
counted towards time spent performing PIN services.
Response: We appreciate the comments providing more context around
how similar services are currently being furnished. See section II.D.
of this rule for more comments on the addition of the SDOH risk
assessment service, HCPCS code G0136, to the Medicare Telehealth List.
We reiterate that HCPCS code G0136 is not intended to be a routine
screening for SDOH at standard intervals or every visit. We agree with
commenters that SDOH risk assessment is related to CHI and PIN
services, and we believe that time spent performing HCPCS code G0136
should count towards the 60 minutes per month spent in the performance
of PIN services.
After consideration of public comments, we are finalizing, as
proposed, a direct crosswalk for HCPCS code G0136 to HCPCS code G0444,
with a work RVU of 0.18, intraservice time of 15 minutes, and matching
direct PE inputs from HCPCS code G0444 to HCPCS code G0136.
e. Principal Illness Navigation (PIN) Services
i. Background
Experts on navigation of treatment for cancer and other high-risk,
serious illnesses have demonstrated the benefits of navigation services
for patients experiencing these conditions.\30\ Experts have noted the
importance of these services for all affected patients, but especially
those with socioeconomic disadvantages or barriers to care. Navigation
generally means the process or activity of ascertaining one's position
and planning and following a route; the act of directing from one place
to another; the skill or process of plotting a route and directing; the
act, activity, or process of finding the way to get to a place you are
traveling. In the context of healthcare, it refers to providing
individualized help to the patient (and caregiver, if applicable) to
identify appropriate practitioners and providers for care needs and
support, and access necessary care timely, especially when the
landscape is complex and delaying care can be deadly. It is often
referred to in the context of patients diagnosed with cancer or another
severe, debilitating illness, and includes identifying or referring to
appropriate supportive services. It is perhaps most critical when a
patient is first undergoing treatment for such conditions, due to the
extensive need to access and coordinate care from a number of different
specialties or service-providers for different aspects of the diagnosis
or treatment, and in some cases, related social services (for example,
surgery, imaging and radiation therapy, chemotherapy for cancer;
psychiatry, psychology, vocational rehabilitation for severe mental
illness; psychiatry, psychology, vocational rehabilitation,
rehabilitation and recovery programs for substance use disorder;
infectious disease, neurology and immunology for human immunodeficiency
virus (HIV)-associated neurocognitive disorders). For some conditions,
patients are best able to engage with the healthcare system and access
care if they have assistance from a single, dedicated individual who
has ``lived experience'' (meaning they have personally experienced the
same illness or condition the patient is facing). Although we currently
make separate payment under the PFS for a number of care management and
other services that may include aspects of navigation services, those
care management services are focused heavily on clinical aspects of
care rather than social aspects and are generally performed by
auxiliary personnel who may not have lived experience or training in
the specific illness being addressed. We sought to better understand
whether there are gaps in coding for patient navigation services for
treatment of serious illness, that are not already included in current
care management services such as advance care planning services (CPT
codes 99497-99498), chronic care management services (CPT codes 99490,
99439, 99491, 99437, 99487 and 99489), general behavioral health
integration care management services (CPT code 99484), home health and
hospice supervision (HCPCS codes G0181-G0182), monthly ESRD-related
services (CPT codes 90951-90970), principal care management services
(CPT codes 99424-99427), psychiatric collaborative care management
services (CPT codes 99492-99494), and transitional care management
services (CPT codes 99495-99496). See
[[Page 78938]]
additional information on our PFS Care Management Services web page at
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Care-Management.
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\30\ See for example, https://view.ons.org/3hjHjc and https://www.accc-cancer.org/docs/projects/pdf/patient-navigation-guide.
---------------------------------------------------------------------------
For CY 2024, we proposed to better recognize through coding and
payment policies when certified or trained auxiliary personnel under
the direction of a billing practitioner, which may include a patient
navigator or certified peer specialist, are involved in the patient's
health care navigation as part of the treatment plan for a serious,
high-risk disease expected to last at least 3 months, that places the
patient at significant risk of hospitalization or nursing home
placement, acute exacerbation/decompensation, functional decline, or
death. Examples of serious, high-risk diseases for which patient
navigation services could be reasonable and necessary could include
cancer, chronic obstructive pulmonary disease, congestive heart
failure, dementia, HIV/AIDS, severe mental illness, and substance use
disorder (SUD). We proposed new coding for Principal Illness Navigation
(PIN) services. In considering the appropriate patient population, we
considered the patient population eligible for principal care
management service codes (CPT codes 99424 through 99427), as well as
clinical definitions of ``serious illness.'' For example, one peer-
review study defined ``serious illness'' as a health condition that
carries a high risk of mortality and either negatively impacts a
person's daily function or quality of life, or excessively strains
their caregivers.\31\ Another study describes a serious illness as a
health condition that carries a high risk of mortality and commonly
affects a patient for several years.\32\ Some measure serious illness
by the amount of urgent health care use (911 calls, emergency
department visits, repeated hospitalizations) and polypharmacy.\33\ The
navigation services such patients need are similar to CHI services (as
outlined previously in this section), but SDOH need(s) may be fewer or
not present; and there are specific service elements that are more
relevant for the subset of patients with serious illness. Accordingly,
we proposed for PIN services a parallel set of services to the CHI
services, but focused on patients with a serious, high-risk illness who
may not necessarily have SDOH needs; and adding service elements to
describe identifying or referring the patient to appropriate supportive
services, providing information/resources to consider participation in
clinical research/clinical trials, and inclusion of lived experience or
training in the specific condition being addressed.
---------------------------------------------------------------------------
\31\ https://pubmed.ncbi.nlm.nih.gov/29125784/.
\32\ https://www.ajmc.com/view/serious-illness-a-high-priority-for-accountable-care.
\33\ https://www.ajmc.com/view/serious-illness-a-high-priority-for-accountable-care.
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Note about definitions: we are finalizing an additional subset of
PIN codes below. For purposes of this section, where we refer to PIN,
we mean all associated PIN codes (HCPCS codes G0023, G0024, G0140, and
G0146). If there are items that do not apply to all, that is noted.
ii. Proposed Principal Illness Navigation (PIN) Service Definition
We proposed that PIN services could be furnished following an
initiating E/M visit addressing a serious high-risk condition/illness/
disease, with the following characteristics:
One serious, high-risk condition expected to last at least
3 months and that places the patient at significant risk of
hospitalization, nursing home placement, acute exacerbation/
decompensation, functional decline, or death;
The condition requires development, monitoring, or
revision of a disease-specific care plan, and may require frequent
adjustment in the medication or treatment regimen, or substantial
assistance from a caregiver.
Examples of a serious, high-risk condition/illness/disease include,
but are not limited to, cancer, chronic obstructive pulmonary disease,
congestive heart failure, dementia, HIV/AIDS, severe mental illness,
and substance use disorder (SUD).
We proposed that the PIN initiating visit would be an E/M visit
(other than a low-level E/M visit that can be performed by clinical
staff) performed by the billing practitioner who will also be
furnishing the PIN services during the subsequent calendar month(s).
The PIN initiating visit would be separately billed (if all
requirements to do so are met) and would be a pre-requisite to billing
for PIN services. We believe that certain types of E/M visits, such as
inpatient/observation visits, ED visits, and SNF visits would not
typically serve as PIN initiating visits because the practitioners
furnishing the E/M services in those settings would not typically be
the ones to provide continuing care to the patient, including
furnishing necessary PIN services in the subsequent month(s).
The PIN initiating visit would serve as a pre-requisite to billing
for PIN services, during which the billing practitioner would identify
the medical necessity of PIN services and establish an appropriate
treatment plan. The subsequent PIN services would be performed by
auxiliary personnel incident to the professional services of the
practitioner who bills the PIN initiating visit. The same practitioner
would furnish and bill for both the PIN initiating visit and the PIN
services, and PIN services must be furnished in accordance with the
``incident to'' regulation at Sec. 410.26. We would not require an
initiating E/M visit every month that PIN services are billed, but only
prior to commencing PIN services, to establish the treatment plan,
specify how PIN services would help accomplish that plan, and establish
the PIN services as incident to the billing practitioner's service.
This framework is similar to our current requirements for billing care
management services, such as chronic care management services. It also
comports with our longstanding policy in the Medicare Benefit Policy
Manual which provides, ``where a physician supervises auxiliary
personnel to assist him/her in rendering services to patients and
includes the charges for their services in his/her own bills, the
services of such personnel are considered incident to the physician's
service if there is a physician's service rendered to which the
services of such personnel are an incidental part. This does not mean,
however, that to be considered incident to, each occasion of service by
auxiliary personnel (or the furnishing of a supply) need also always be
the occasion of the actual rendition of a personal professional service
by the physician. Such a service or supply could be considered to be
incident to when furnished during a course of treatment where the
physician performs an initial service and subsequent services of a
frequency which reflect his/her active participation in and management
of the course of treatment'' (Chapter 15, Section 60.1.B of the
Medicare Benefit Policy Manual (Pub. 100-02), available on our website
at https://www.cms.gov/regulations-and-guidance/guidance/manuals/downloads/bp102c15.pdf.
We also solicited comment on whether we should consider any
professional services other than an E/M visit performed by the billing
practitioner as the prerequisite initiating visit for PIN services,
including, for example, an AWV that may or may not include the optional
SDOH risk assessment. Under section 1861(hhh)(3)(C) of the Act, the AWV
can be furnished by a physician or practitioner, or by other types of
health professionals whose scope of practice does not include the
diagnosis and
[[Page 78939]]
treatment involved in E/M services, for example a health educator.
We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: Commenters overwhelmingly supported this proposed code.
Several commenters expressed support for PIN services but requested
that CMS exempt PIN services from budget neutrality. Many commenters
discussed the wide range of benefits navigation services can have on a
variety of conditions. Some commenters discussed the important health
equity implications for such a proposal, citing research showing that
members of historically disadvantaged communities and communities of
color often receive lower rates of patient navigation, are often
diagnosed with serious, high-risk illnesses like cancer at later
stages, and have longer times between suspicion and definitive
diagnosis for conditions like cancer. Many of these inequities are tied
to access issues, and commenters suggested that PIN services would fill
a critical gap in navigation services, noting that many navigation
programs are currently grant-funded and unable to serve all patients
that might benefit. Commenters also opined on the benefits of
condition-specific navigation, discussing the value of navigators with
targeted training or lived experience in the conditions for which they
are providing navigation services.
We received many comments requesting that CMS clarify the
definition of a serious, high-risk condition, the expected duration of
the illness, and whether conditions beyond those we listed are
appropriate. Commenters stated that CMS should not limit the timeframe
to an expected duration of 3 months, discussing that there are many
conditions that meet all requirements listed by CMS of a serious, high-
risk condition, but that may be treated with the patient being cured or
in remission within a 3-month period. Many commenters applauded our
inclusion of severe mental illness and substance use disorder (SUD) as
serious, high-risk conditions and noted that PIN services could be very
impactful for these beneficiaries. Other commenters requested
clarification on conditions such as chronic liver disease, chronic
kidney disease, stroke, diabetes, and conditions with treatments that
require stem cell transplantation.
Response: With respect to budget neutrality, we remind commenters
that section 1848(c)(2)(B)(ii)(II) of the Act requires that increases
or decreases in RVUs may not cause the amount of Medicare Part B
expenditures for the year to differ by more than $20 million from what
expenditures would have been in the absence of these changes. If this
threshold is exceeded, we must make adjustments to preserve budget
neutrality. There is no statutory exception available for PIN services,
so the expected spending associated with these services must be
included in the CY 2024 BN adjustment.
As we noted in the proposed rule, the definition of a serious,
high-risk condition is dependent on clinical judgement. The list of
conditions we provided is not exhaustive, and we will monitor
utilization across beneficiaries and specialties to ascertain where and
how PIN services are best utilized going forward. We agree with the
commenters that additional conditions such as chronic liver disease,
chronic kidney disease, stroke, and conditions that require stem cell
transplantation could all meet the outlined definition depending on the
specific severity of the illness in individuals with these conditions.
We disagree with commenters who requested the inclusion of conditions
that can be treated fully within the 3-month timeframe, as we do not
believe a condition of this limited duration would require the extent
of navigation services provided by PIN. We believe that an expected 3-
month period is a reasonable benchmark for the use of PIN services, as
we envision PIN services as necessary to treat serious, high-risk
conditions that require navigation over the course of several months.
Comment: Many commenters recommended that CMS should not restrict
PIN initiating visits to only E/M visits. Commenters noted that for
many beneficiaries with severe mental illness or substance use disorder
(SUD), a clinical psychologist may be the only health care practitioner
they see regularly. Since clinical psychologists do not furnish E/M
services, these beneficiaries would be unable to benefit from PIN
services. Several commenters recommended including Behavioral Health
Integration (BHI) and bundled office-based substance use disorder codes
as initiating visits. Other commenters noted that inpatient/observation
E/M visits and ED visits should count as initiating visits. Some
commenters requested that CMS address whether TCM services would count
as an initiating visit, further commenting that some serious, high-risk
conditions are diagnosed in the hospital or similar setting, and PIN
services would be beneficial upon discharge from such a facility. Many
commenters also requested that the AWV count as an initiating visit for
PIN. We received comments from dementia practitioners stating that the
AWV includes a cognitive decline assessment, and positive results would
likely prompt a practitioner to order PIN services. Commenters also
requested clarification regarding the requirement that the initiating
visit be completed by the practitioner who will be furnishing PIN
services during the subsequent calendar months, with commenters
discussing the burden of supervision for ongoing PIN services if one
practitioner was covering for another practitioner, had the initiating
visit for PIN, and would then transition care back to the returning
practitioner after PIN services had started.
Response: We appreciate the commenters' views and specific examples
of how PIN services may be furnished. We thank the commenters for
pointing out that clinical psychologists may be the practitioner type
that primarily interfaces with beneficiaries with severe mental illness
and SUD, and that they would be unable to furnish PIN given the
proposed requirement for an E/M initiating visit. We agree with
commenters that clinical psychologists should be able to bill PIN
codes, especially for those with behavioral health conditions. We note
that clinical psychologists have an incident to benefit under Sec.
410.26, and clinical psychologists most commonly use CPT code 90791
(Psychiatric diagnostic evaluation) and the Health Behavior Assessment
and Intervention (HBAI) services described by CPT codes 96156, 96158,
96159, 96164, 96165, 96167, and 96168 to diagnose and treat behavioral
health conditions as analogous codes to E/M, based on the services
clinical psychologists are allowed to furnish under State law and scope
of practice. We note that the BHI codes and office-based substance use
disorder bundled codes also describe care management services. We
believe considering those codes as an initiating visit for PIN would be
duplicative, as they also require an initiating visit, but that is
specified for those services. Therefore, we believe they would not
serve the purpose of an initiating visit, which is meant to establish
the beneficiary's relationship with the furnishing practitioner, ensure
the practitioner assesses the beneficiary and identifies a clinical
need for services prior to initiating care management, and provide an
opportunity to inform the beneficiary about the services and obtain
beneficiary consent (if applicable).
We agree with commenters that the E/M visit done as part of a
Transitional Care Management (TCM) services could
[[Page 78940]]
serve as an initiating visit for PIN services because it includes a
high-level office/outpatient E/M visit furnished by a physician or
nonphysician practitioner managing the patient in the community after
discharge.
We appreciate the commenters' suggestions about including the AWV
as a type of initiating visit, and the comments from dementia
practitioners who discussed that the cognitive decline assessment in
the AWV may be a flag for initiating PIN services. In these
circumstances the personalized prevention plan services may include
elements for further diagnosis and treatment of cognitive impairment
and dementia, which may count as a high-risk condition in certain
clinical scenarios based on clinical judgement. We acknowledge that an
AWV may be provided by health care practitioners who do not have the
authority to diagnose or treat medical conditions. To this end, we
believe it would be inconsistent with our proposed application of the
``incident to'' regulations, as a condition of payment, to allow an AWV
furnished by a health care practitioner, other than a physician or
qualified health care practitioner, to serve as the initiating visit
for PIN services. Given that the AWV is a preventative service, there
may be instances where the patient sees a medical professional
(including a health educator, a registered dietitian, or nutrition
professional, or other licensed practitioner) or a team of such medical
professionals, working under the direct supervision of a physician
where an SDOH need may be identified. Additionally, the Personalized
Prevention Plan that is part of AWV may also help a patient who has
identified in the AWV a high-risk condition(s) that meets the standard
for PIN, and the high-risk condition may be part of the focus of the
recommended Personalized Prevention Plan.
There is no benefit under the PFS for facility settings in
accordance with the ``incident to'' regulation at Sec. 410.26. Since
PIN services are provided under incident to regulations, inpatient/
observation E/M visits and ED visits cannot serve as initiating visits
for the purpose of PIN. We also continue to believe that the furnishing
practitioner should have continuity from initiating visit through the
supervision of PIN services, given the medical necessity of PIN
services, and the formation of the appropriate treatment plan specific
to that patient. This framework is similar to the current requirements
for billing care management services, and the requirements for billing
CHI services that we are finalizing in this rule. PIN services are
furnished over the course of a month, and we note that patients do not
stay in inpatient, observation, or ED settings for one month, making
practitioners in this setting unable to furnish PIN services for the
duration of the month, as required under incident to requirements.
After consideration of public comments, we are finalizing CPT code
90791 (Psychiatric diagnostic evaluation) and the Health Behavior
Assessment and Intervention (HBAI) services described by CPT codes
96156, 96158, 96159, 96164, 96165, 96167, and 96168 as initiating
visits for PIN services, as we believe these are the most analogous
codes to E/M codes that are utilized by clinical psychologists.
We are also finalizing that the AWV may serve as an initiating
visit for PIN services when the AWV is furnished by a practitioner who
has identified in the AWV a high-risk condition(s) that would qualify
for PIN services under this rule.
For purposes of assigning a supervision level for payment, we
proposed to designate PIN services as care management services that may
be furnished under general supervision under Sec. 410.26(b)(5).
General supervision means the service is furnished under the
physician's (or other practitioner's) overall direction and control,
but the physician's (or other practitioner's) presence is not required
during the performance of the service (Sec. 410.26(a)(3)).
We proposed the following codes for PIN services. As described
previously, and in our proposed PIN code descriptors, the term ``SDOH
need(s)'' means an SDOH need(s) that is identified by the billing
practitioner as significantly limiting the practitioner's ability to
diagnose or treat the serious, high-risk condition/illness/disease
addressed in the initiating visit. We note that SDOH needs are not
required for use PIN services but may be applicable. ``Addressed''
means the definition in the CPT E/M Guidelines that we have adopted for
E/M visits. Specifically, ``[a] problem is a disease, condition,
illness, injury, symptom, finding, complaint, or other matter addressed
at the encounter, with or without a diagnosis being established at the
time of the encounter. Problem addressed [means the following]: A
problem is addressed or managed when it is evaluated or treated at the
encounter by the physician or other qualified healthcare professional
reporting the service. This includes consideration of further testing
or treatment that may not be elected by virtue of risk/benefit analysis
or patient/parent/guardian/surrogate choice. Notation in patient's
medical record that another professional is managing the problem
without additional assessment or care coordination documented does not
qualify as being addressed or managed by the physician or other
qualified healthcare professional reporting the service. Referral
without evaluation (by history, examination, or diagnostic study[ies])
or consideration of treatment does not qualify as being addressed or
managed by the physician or other qualified healthcare professional
reporting the service.
For purposes of PIN services, we proposed that SDOH means economic
and social condition(s) that influence the health of people and
communities, as indicated in these same CPT E/M Guidelines (2023 CPT
codebook, page 11). We proposed to adopt CPT's examples of SDOH, with
additional examples. Specifically, we proposed that SDOH(s) may include
but are not limited to food insecurity, transportation insecurity,
housing insecurity, and unreliable access to public utilities, when
they significantly limit the practitioner's ability to diagnose or
treat the serious, high-risk illness/condition/disease.
G0023--Principal Illness Navigation services by certified or
trained auxiliary personnel under the direction of a physician or other
practitioner, including a patient navigator or certified peer
specialist; 60 minutes per calendar month, in the following activities:
Person-centered assessment, performed to better understand
the individual context of the serious, high-risk condition.
++ Conducting a person-centered assessment to understand the
patient's life story, strengths, needs, goals, preferences, and desired
outcomes, including understanding cultural and linguistic factors.
++ Facilitating patient-driven goal setting and establishing an
action plan.
++ Providing tailored support as needed to accomplish the
practitioner's treatment plan.
Identifying or referring patient (and caregiver or family,
if applicable) to appropriate supportive services.
Practitioner, Home, and Community-Based Care Coordination
++ Coordinating receipt of needed services from healthcare
practitioners, providers, and facilities; home- and community-based
service providers; and caregiver (if applicable).
++ Communication with practitioners, home-, and community-based
service providers, hospitals, and skilled nursing facilities (or other
health care facilities) regarding the patient's psychosocial strengths
and needs,
[[Page 78941]]
functional deficits, goals, preferences, and desired outcomes,
including cultural and linguistic factors.
++ Coordination of care transitions between and among health care
practitioners and settings, including transitions involving referral to
other clinicians; follow-up after an emergency department visit; or
follow-up after discharges from hospitals, skilled nursing facilities
or other health care facilities.
++ Facilitating access to community-based social services (e.g.,
housing, utilities, transportation, food assistance) as needed to
address SDOH need(s).
Health education--Helping the patient contextualize health
education provided by the patient's treatment team with the patient's
individual needs, goals, preferences, and SDOH need(s), and educating
the patient (and caregiver if applicable) on how to best participate in
medical decision-making.
Building patient self-advocacy skills, so that the patient
can interact with members of the health care team and related
community-based services (as needed), in ways that are more likely to
promote personalized and effective treatment of their condition.
Health care access/health system navigation.
++ Helping the patient access healthcare, including identifying
appropriate practitioners or providers for clinical care, and helping
secure appointments with them.
++ Providing the patient with information/resources to consider
participation in clinical trials or clinical research as applicable.
Facilitating behavioral change as necessary for meeting
diagnosis and treatment goals, including promoting patient motivation
to participate in care and reach person-centered diagnosis or treatment
goals.
Facilitating and providing social and emotional support to
help the patient cope with the condition, SDOH need(s), and adjust
daily routines to better meet diagnosis and treatment goals.
Leverage knowledge of the serious, high-risk condition
and/or lived experience when applicable to provide support, mentorship,
or inspiration to meet treatment goals.
G0024--Principal Illness Navigation services, additional 30 minutes
per calendar month (List separately in addition to G0023).
To help inform whether our descriptor times are appropriate and
reflect typical service times, and whether a frequency limit is
relevant for the add-on code, we solicited comment on the typical
amount of time practitioners spend per month furnishing PIN services.
We also solicited comment to better understand the typical duration of
PIN services, in terms of the number of months for which practitioners
furnish PIN services following an initiating visit.
We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: Commenters were very supportive of including PIN as a care
management service that may be furnished under general supervision.
Commenters were overwhelmingly supportive of our inclusion of patient
navigators in the code description, with many comments focusing on the
breadth of types of patient navigators in relation to the treatment of
serious, high-risk conditions. These commenters were supportive of the
required service element activities outlined in the proposal.
Commenters were generally not in favor of limiting the frequency of the
add-on code, and many commenters stated that navigation time spent per
month is greatly dependent on the condition or illness for which it is
being provided and the needs of the beneficiary being served. A few
commenters discussed that CMS could add flexibility in for those
patients who require a lot of navigation time per month by not limiting
the frequency of the add-on code. Commenters working in the cancer/
oncology space estimated an average duration of 6 months of navigation,
and commenters from the dementia care community suggested navigation of
3-6 months duration. Comments related to the amount of time per month
varied widely, with many commenters in general discussing the
difficulty and burden in trying to capture every minute of service
time.
Response: We appreciate the varying nature of requirements for
navigation across conditions. We strive to strike a balance, and we
will monitor utilization and feedback from interested parties going
forward to determine if changes need to be made. We appreciate the
comments regarding a duration of 3-6 months across different
conditions, as this aligns with our vision that PIN services will
likely be needed for several months. We appreciate the difficulty named
by commenters in estimating an ``average'' amount of time per month, as
conditions and circumstances vary widely. We agree that the add-on code
offers flexibility to provide more time if needed to patients, and we
understand that if we limited the use of the add-on codes, we would be
limiting the amount of time spent per month on navigation around an
average that not every patient fits into.
Comment: Several commenters suggested that HCPCS code G0023 be
broken into 20-minute increments, with 3 increments making up the first
code, and HCPCS code G0024 describing an additional 30 minutes. One
commenter suggested increasing HCPCS code G0023 to 120 minutes and
another commenter suggested that months 1 and 2 of PIN services should
be 120 minutes, then subsequent months decreased to 60 minutes per
month as intensity of navigation decreases after the initial diagnosis
and treatment period. A few commenters suggested no limit on the
duration of PIN services, while another commenter suggested that
another initiating visit be required every 6 months. Some commenters
suggested that a timed code was not the best for this type of service
and suggested CMS adopt a per member per month flat fee. Lastly,
several commenters requested clarification on whether PIN services
could start before definitive diagnosis, noting that for some types of
cancer, there is not a definitive diagnosis until a surgical
intervention has been performed, but that there are many steps leading
up to that, and current navigation programs often start with
practitioner suspicion of such a diagnosis, for example after a
positive screening test such as a mammogram. Commenters noted that this
impacts the duration of expected PIN services, as it can often be a
month or more between suspicion and definitive diagnosis. These
commenters also cited research outlining health equity impacts, as many
underserved communities have higher rates of late diagnosis due to
delayed follow-up. These commenters stated that early navigation is
currently being used to get patients, especially those in underserved
communities, to a definitive diagnosis faster.
Response: We understand the variability in the time that can be
spent providing navigation services, given the diverse nature of what
we have defined as a ``serious, high-risk illness.'' We continue to
believe that PIN services should reflect a substantial amount of time
spent per month in the navigation of the principal illness. We believe
that if a patient requires less than 60 minutes per month for PIN
services, then their needs may be best suited to other types of care
management services. We thank the commenters for discussing the
expected duration of PIN services in the context of how frequently the
initiating visit should be performed. We disagree that a new initiating
visit should be required every 6 months, but we do believe that
requiring one every year
[[Page 78942]]
would be an appropriate middle ground between every 6 months and not
requiring one as long as the serious, high-risk condition persists. We
agree with commenters that the length of time between suspicion (such
as a positive screening test) and definitive diagnosis can stretch into
weeks for some conditions, and navigation services may be medically
necessary to ensure full diagnosis and treatment of that condition. We
note that our definition of a ``high risk condition'' does not exclude
conditions without a definitive diagnosis. For example, a patient may
have a mass in the colon identified on a CT scan of the abdomen.
Regardless of the definitive diagnosis of the mass, presence of a
colonic mass for that patient may be a serious high-risk condition that
could, for example, cause obstruction and lead the patient to present
to the emergency department, as well as be potentially indicative of an
underlying life-threatening illness such as colon cancer. As such, a
practitioner could exercise clinical judgement and determine that the
mass represents a serious high-risk condition for that patient, and
that PIN services should be furnished as part of the early treatment
plan. Therefore, we are clarifying that a definitive diagnosis is not
required before the practitioner makes a clinical determination that
the patient has a serious high-risk condition.
Comment: We received several comments about our proposals for PIN
and the SDOH risk assessment requesting that CMS clarify the
requirements surrounding the reassessment of unmet social needs and
proposed frequency limitations. Commenters also noted that there was no
defined activity within the proposed PIN elements of service to perform
an SDOH risk assessment and sought clarification on the intersection
between PIN and the SDOH risk assessment code.
Response: We agree with commenters that the reassessment of known
SDOH needs is interrelated to PIN services, especially within the
presence of a serious, high-risk condition. We also agree that this
reassessment should not be confined to the frequency limitations
described for HCPCS code G0136.
Comment: We received many comments from the peer support community
applauding our inclusion of certified peer support specialists in the
code descriptor for PIN services. Commenters were effusive in their
support for the use and benefits of peer support specialists for
beneficiaries with behavioral health conditions like severe mental
illness and SUD. Peer support specialists also appreciated the
inclusion of lived experience as a key element to PIN services and
noted that this lived experience is a particular strength and benefit
that peer support specialists bring to their patients. These commenters
discussed the fear and mistrust that commonly exists within the medical
community regarding behavioral health conditions, and these commenters
noted that peer support specialists help bridge that gap, as their
lived experience enables them to be a trusted and safe member of the
care team. Many of these commenters stated that, while they are
certified and trained to perform many of the activities listed in the
code descriptor, care coordination activities fall outside the scope of
certified peer support specialists. We required in our proposal that
auxiliary personnel performing PIN services be certified or trained to
perform all activities, and these commenters stated that this
requirement would effectively exclude peer support specialists from
performing PIN services. These commenters discussed that beneficiaries
with severe mental illness and SUD would benefit from the significant
set of activities described for PIN services that peer specialists are
qualified to perform and urged CMS to create unique coding for PIN
performed by peer support specialists, removing the requirements that
fall outside of peer support specialist expertise.
Several commenters discussed that, given low reimbursement rates
throughout the health care industry for peer support services, many
clinicians do not have experience working with peer support
specialists, and misinformation about the role abounds. Commenters
acknowledged that one way to include peer support specialists in HCPCS
codes G0023 and G0024 would be to remove the requirement as proposed
for all PIN auxiliary staff to be trained and certified in all service
elements of PIN. However, these commenters described that peer support
specialists are often asked to perform tasks outside of their
competency and role. These commenters discussed the difficulty they
face in clinical settings when the expectations placed on them by
clinical practitioners do not align with what peer support specialists
understand to be their scope and role on the treatment team. These
commenters stated concern that having care management activities listed
in the service descriptor but not required would further
misunderstanding about the peer support specialist role and would lead
to peer support specialists being asked to complete those tasks.
Commenters also suggested that CMS remove the care coordination
elements in the PIN code descriptors altogether to align these services
with peer support competencies. We also received many comments
recommending that CMS should align the PIN activities with SAMHSA's
National Model Standards for Certification \34\ for peer support
workers.
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\34\ https://www.samhsa.gov/about-us/who-we-are/offices-centers/or/model-standards.
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Commenters were generally aligned on the specific items they noted
were outside of the scope of peer support specialists but differed on
how to handle these items. Below is a list of the items in the PIN
descriptor on which we received comment.
One commenter recommended removing Person-centered
assessment, performed to better understand the individual context of
the serious, high-risk condition. The same commenter recommended
changing ++ Conducting a person-centered assessment to understand the
patient's life story, strengths, needs, goals, preferences, and desired
outcomes, including understanding cultural and linguistic factors, and
including unmet SDOH needs (that is not separately billed) to ++
Conducting a person-centered interview. Most commenters recommended
changing ++ Providing tailored support as needed to accomplish the
practitioner's treatment plan to ++ Providing tailored support as
needed to accomplish the person-centered goals in the practitioner's
treatment plan, while another commenter removed this item.
Response: We thank the commenters for their feedback. The peer
support community has told us through public comment that they have
issues with scope of work, and they are frequently asked to perform
tasks outside of their scope of practice. We defer to the peer support
community with their suggestion of changing the word assessment to
interview to make the language more consistent with peer support
competencies and scope of practice. We also believe it is important to
explicitly state items to be included in the interview. We agree with
the commenters who suggested modifying this bullet to ``person-centered
goals'' in the treatment plan, as this is in alignment with both peer
support values as stated by the commenters and maintains the intention
of the descriptor.
Comment: All commenters recommended either renaming
Practitioner, Home, and Community-Based Care Coordination to
Practitioner, Home, and Community-
[[Page 78943]]
Based Care Communication or removing this bullet. All commenters
recommended removing ++ Coordinating receipt of needed services from
healthcare practitioners, providers, and facilities; home- and
community-based service providers; and caregiver (if applicable).
Commenters either recommended removing this bullet or renaming ++
Communication with practitioners, home-, and community-based service
providers, hospitals, and skilled nursing facilities (or other health
care facilities) regarding the patient's psychosocial strengths and
needs, functional deficits, goals, preferences, and desired outcomes,
including cultural and linguistic factors to ++ Assisting the patient
in communicating with their practitioners, home-, and community-based
service providers, hospitals, and skilled nursing facilities (or other
health care facilities) regarding the patient's psychosocial strengths
and needs, functional deficits, goals, preferences, and desired
outcomes, including cultural and linguistic factors.
All commenters recommended removing ++ Coordination of care
transitions between and among health care practitioners and settings,
including transitions involving referral to other clinicians; follow-up
after an emergency department visit; or follow-up after discharges from
hospitals, skilled nursing facilities or other health care facilities.
Response: We largely defer to the commenters' judgements about
these word choices, but we agree that ``assisting the patient in
communicating'' with practitioners is largely analogous to
communicating on behalf of patients, and we appreciate the intention to
leave this important facet of all navigation services in the PIN code.
Given that all commenters were in favor of removing some bullets, we
again defer to the peer support community.
All commenters recommended removing Health care access/
health system navigation.
++ Helping the patient access healthcare, including identifying
appropriate practitioners or providers for clinical care, and helping
secure appointments with them.
++ Providing the patient with information/resources to consider
participation in clinical trials or clinical research as applicable.
Response: We thank the commenters for their feedback. Given that
commenters were unanimous in removing these items from the descriptor,
we support removing them from the PIN-PS descriptor.
Comment: Commenters were split on the descriptor
Facilitating behavioral change as necessary for meeting diagnosis and
treatment goals, including promoting patient motivation to participate
in care and reach person-centered diagnosis or treatment goals. Some
commenters suggested removal of this bullet, whereas others recommended
rewriting to Developing and proposing strategies to help meet
person-centered treatment goals and supporting the patient in using
chosen strategies to reach person-centered treatment goals.
Response: We believe the inclusion of strategizing with a patient
to help them meet their treatment goals is an important element of PIN
services. We support the revision of this bullet to emphasize the
person-centered approach to treatment goals and assisting the patient
in using individualized strategies towards this aim.
Comment: Commenters also differed on Facilitating and
providing social and emotional support to help the patient cope with
the condition, SDOH need(s), and adjust daily routines to better meet
diagnosis and treatment goals. A few commenters suggested the addition
of person-centered to meet the diagnosis and treatment goals, whereas
others removed everything after daily routines. One commenter
recommended editing Leverage knowledge of the serious, high-
risk condition and/or lived experience when applicable to provide
support, mentorship, or inspiration to meet treatment goals to end
after inspiration, removing mention of meeting treatment goals.
Response: We continue to believe that the intersection of the
diagnosis and treatment goals with the support provided to the patient
is essential to the success of PIN services. We also support the
revision throughout these code descriptors to emphasize the ``person-
centeredness'' of diagnosis and treatment goals.
We are sympathetic to the nuances of the interactions between peer
support specialists and clinicians, and we appreciate the peer support
community for bringing these issues to our attention. We agree with the
value and benefit of having peer support specialists as part of the
treatment team for those with severe mental illness and SUD. We are
clarifying that our intention in creating the PIN service elements was
to include a navigation role for certified peer support specialists in
the treatment of severe mental illness and SUD. We believe that it is
important to preserve the care management elements of PIN that can be
performed by other types of health care professionals, and which are
important to PIN for many serious, high-risk conditions. We also
recognize the role that peer support specialists can serve in providing
navigation for patients with severe mental illness and SUD through PIN
services. We thank the commenters for their efforts in specifically
describing the items in the PIN service descriptor that they believe
fall outside of the scope of a peer support specialist. We understand
that, given the misalignment that can occur between clinical
practitioners and peer support specialists regarding their role on the
treatment team outlined in the peer support specialists' comments, it
is important to be as specific when possible to avoid misunderstanding
about the types of auxiliary personnel we envision performing these
services. We believe that further defining the role of peer support
specialists within PIN codes will help alleviate this misalignment. We
note that the comments were generally unified around the removal or
modification of some items, and we believe that the overall nature and
value PIN services provide to behavioral health patients is unchanged
from the original PIN descriptor.
As described by the commenters, the conducting of a person-centered
assessment or interview to understand the patient's life remains
critical to the medical benefit of navigation for serious, high-risk
conditions including behavioral health conditions. Discussing goal
setting, establishing an action plan, and identifying or referring the
patient to appropriate supportive services is important to ensuring
behavioral health patients stay engaged in the treatment of their
principal illness. As discussed previously, we heard from commenters
that many patients with behavioral health conditions have unmet SDOH
needs, and service elements such as facilitating access to community-
based social services, health education, and building patient self-
advocacy skills all help patients better understand their condition,
contextualize their principal illness within their lives, and advocate
for themselves both in and out of health care settings with the aim of
improving their diagnosis and treatment of said condition.
After consideration of public comments, we are finalizing the
service elements, descriptors, and time per month for HCPCS codes G0023
and G0024 generally as proposed, with the addition of ``and including
unmet SDOH needs (that are not separately billed)'' as part of the
person-centered assessment. This addition is in response
[[Page 78944]]
to comments made in both the HCPCS code G0136 and PIN sections
regarding the intersection of the SDOH risk assessment code. This
service element describes the need to reassess SDOH needs within both
CHI and PIN and allows for time spent performing SDOH reassessment that
is not otherwise billed to count towards CHI and PIN services. We
clarify that this time cannot be duplicated by HCPCS code G0136 or any
other service. Below are the final code descriptors for HCPCS codes
G0023 and G0024.
G0023--Principal Illness Navigation services by certified or
trained auxiliary personnel under the direction of a physician or other
practitioner, including a patient navigator or certified peer
specialist; 60 minutes per calendar month, in the following activities:
Person-centered assessment, performed to better understand
the individual context of the serious, high-risk condition.
++ Conducting a person-centered assessment to understand the
patient's life story, strengths, needs, goals, preferences, and desired
outcomes, including understanding cultural and linguistic factors and
including unmet SDOH needs (that are not separately billed).
++ Facilitating patient-driven goal setting and establishing an
action plan.
++ Providing tailored support as needed to accomplish the
practitioner's treatment plan.
Identifying or referring patient (and caregiver or family,
if applicable) to appropriate supportive services.
Practitioner, Home, and Community-Based Care Coordination.
++ Coordinating receipt of needed services from healthcare
practitioners, providers, and facilities; home- and community-based
service providers; and caregiver (if applicable).
++ Communication with practitioners, home-, and community-based
service providers, hospitals, and skilled nursing facilities (or other
health care facilities) regarding the patient's psychosocial strengths
and needs, functional deficits, goals, preferences, and desired
outcomes, including cultural and linguistic factors.
++ Coordination of care transitions between and among health care
practitioners and settings, including transitions involving referral to
other clinicians; follow-up after an emergency department visit; or
follow-up after discharges from hospitals, skilled nursing facilities
or other health care facilities.
++ Facilitating access to community-based social services (e.g.,
housing, utilities, transportation, food assistance) as needed to
address SDOH need(s).
Health education--Helping the patient contextualize health
education provided by the patient's treatment team with the patient's
individual needs, goals, preferences, and SDOH need(s), and educating
the patient (and caregiver if applicable) on how to best participate in
medical decision-making.
Building patient self-advocacy skills, so that the patient
can interact with members of the health care team and related
community-based services (as needed), in ways that are more likely to
promote personalized and effective treatment of their condition.
Health care access/health system navigation.
++ Helping the patient access healthcare, including identifying
appropriate practitioners or providers for clinical care, and helping
secure appointments with them.
++ Providing the patient with information/resources to consider
participation in clinical trials or clinical research as applicable.
Facilitating behavioral change as necessary for meeting
diagnosis and treatment goals, including promoting patient motivation
to participate in care and reach person-centered diagnosis or treatment
goals.
Facilitating and providing social and emotional support to
help the patient cope with the condition, SDOH need(s), and adjust
daily routines to better meet diagnosis and treatment goals.
Leverage knowledge of the serious, high-risk condition
and/or lived experience when applicable to provide support, mentorship,
or inspiration to meet treatment goals.
G0024--Principal Illness Navigation services, additional 30 minutes
per calendar month (List separately in addition to G0023).
For certified peer support specialists, we continue to believe the
work provided by peer support specialists is crucial to the treatment
of some patients with behavioral health conditions. We attempted to
recognize this work with our proposed PIN code, but given the public
comments we received, we are also finalizing two new codes, HCPCS code
G0140 and HCPCS code G0146 for Principal Illness Navigation--Peer
Support (PIN-PS). Given the nature of work typically performed by peer
support specialists, we are limiting these codes to the treatment of
behavioral health conditions that otherwise satisfy our definition of a
high-risk condition(s). Patients with behavioral health conditions can
still receive HCPCS code G0023 and HCPCS code G0024 services, so long
as the auxiliary staff providing them is trained and certified in all
parts of those code descriptors. We understand that behavioral health
patients are not a monolith, and some patients may be best suited to
traditional PIN services.
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, in the following activities:
Person-centered interview, performed to better understand
the individual context of the serious, high-risk condition.
++ Conducting a person-centered interview to understand the
patient's life story, strengths, needs, goals, preferences, and desired
outcomes, including understanding cultural and linguistic factors, and
including unmet SDOH needs (that are not billed separately).
++ Facilitating patient-driven goal setting and establishing an
action plan.
++ Providing tailored support as needed to accomplish the person-
centered goals in the practitioner's treatment plan.
Identifying or referring patient (and caregiver or family,
if applicable) to appropriate supportive services.
Practitioner, Home, and Community-Based Care Communication
++ Assist the patient in communicating with their practitioners,
home-, and community-based service providers, hospitals, and skilled
nursing facilities (or other health care facilities) regarding the
patient's psychosocial strengths and needs, goals, preferences, and
desired outcomes, including cultural and linguistic factors.
++ Facilitating access to community-based social services (e.g.,
housing, utilities, transportation, food assistance) as needed to
address SDOH need(s).
Health education--Helping the patient contextualize health
education provided by the patient's treatment team with the patient's
individual needs, goals, preferences, and SDOH need(s), and educating
the patient (and caregiver if applicable) on how to best participate in
medical decision-making.
Building patient self-advocacy skills, so that the patient
can interact with members of the health care team and related
community-based services (as needed), in ways that are more likely to
promote personalized and effective treatment of their condition.
Developing and proposing strategies to help meet person-
centered treatment goals and supporting the patient in
[[Page 78945]]
using chosen strategies to reach person-centered treatment goals.
Facilitating and providing social and emotional support to
help the patient cope with the condition, SDOH need(s), and adjust
daily routines to better meet person-centered diagnosis and treatment
goals.
Leverage knowledge of the serious, high-risk condition
and/or lived experience when applicable to provide support, mentorship,
or inspiration to meet treatment goals.
G0146--Principal Illness Navigation--Peer Support, additional 30
minutes per calendar month (List separately in addition to G0140).
We are not finalizing a frequency limitation for the services
described by HCPCS codes G0024 or G0146, and we will monitor
utilization of these codes going forward to ascertain the time spent
per month per PIN service. We are not limiting the duration PIN
services, but we are finalizing a requirement that a new initiating
visit be conducted once per year. We proposed that all auxiliary
personnel who provide PIN services must be certified or trained to
provide all elements in the corresponding service and be authorized to
perform them under applicable State law and regulations. Under Sec.
410.26(a)(1) of our regulations, auxiliary personnel must meet any
applicable requirements to provide incident to services, including
licensure, imposed by the State in which the services are being
furnished. Many States have applicable rules and certifications, and
there are existing certification programs for navigators working in
certain settings of care or with specified conditions, such as cancer
navigators, diabetes navigators, cardiovascular navigators, mental
health navigators, geriatric care navigators, pediatric navigators,
social worker navigators, primary care navigators, general patient
advocate navigators, and nurse navigators in ambulatory settings.\35\
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\35\ https://resumecat.com/blog/patient-navigator-certifications.
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For peer support specialists, approximately 48 States have
professional certification programs for those providing services to
patients with substance use or mental health conditions. States may
include qualified peer support specialist in their Medicaid programs.
In 2007, the Center for Medicaid and CHIP Services published guidance
outlining minimum requirements for peer support specialist
participating in Medicaid as follows: peer support specialists must be
self-identified consumers who are in recovery from mental illness and/
or substance use disorders, supervised by a competent mental health
professional, and complete training that provides peer support
specialists with a basic set of competencies necessary to perform the
peer support function, including demonstrating the ability to support
the recovery of others from mental illness and/or substance use
disorders and ongoing continual educational requirements.\36\ In States
with professional certification programs, training and certification
requirements vary, with an average of 40 and 46 hours of initial
approved education, with almost all States requiring either a written
or written and oral exam. A little less than half of States also
require supervised work or volunteer hours to obtain certification.\37\
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\36\ https://downloads.cms.gov/cmsgov/archived-downloads/smdl/downloads/smd081507a.pdf.
\37\ https://peerrecoverynow.org/wp-content/uploads/2023-FEB-07-prcoe-comp-analysis.pdf.
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In States that do not have applicable licensure, certification, or
other laws or regulations governing the certification or training of
auxiliary personnel, we proposed to require auxiliary personnel
providing PIN services be trained to provide all service elements.
Training must include the competencies of patient and family
communication, interpersonal and relationship-building, patient and
family capacity building, service coordination and systems navigation,
patient advocacy, facilitation, individual and community assessment,
professionalism and ethical conduct, and the development of an
appropriate knowledge base, including specific certification or
training on the serious, high-risk condition/illness/disease addressed
in the initiating visit. We proposed these competencies because we
believe they reflect professional consensus regarding appropriate core
competencies, adjusted to this context.\38\ We solicited public comment
on the number of hours of training to require, as well as the training
content and who should provide the training.
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\38\ https://view.ons.org/3hjHjc and https://www.accc-cancer.org/docs/projects/pdf/patient-navigation-guide; https://chwtraining.org/c3-project-chw-skills/; and https://peerrecoverynow.org/wp-content/uploads/Comparative-Analysis_Jan.31.2022-003.pdf; https://www.samhsa.gov/sites/default/files/national-model-standards-for-peer-support-certification.pdf?utm_source=SAMHSA&utm_campaign=4b88ba3e51-EMAIL_CAMPAIGN_2023_06_05_02_41&utm_medium=email&utm_term=0_-4b88ba3e51-%5BLIST_EMAIL_ID%5D.
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We 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, outside of the peer support
specialist community, regarding training and certification for
auxiliary personnel providing PIN service elements. One commenter
emphasized the importance of training and/or lived experience with the
relevant condition to the PIN services being provided, and this
commenter suggested training for all auxiliary personnel should require
case studies for each condition for which the auxiliary personnel will
be providing navigation. Commenters were split on whether a standard
amount of training hours should be required, with one commenter
suggesting 8 hours per year, and another commenter suggesting a
requirement of 225 hours for the initial training. Another commenter
suggested all navigators be trained in oncology navigation, given the
prevalence of cancer in many communities, regardless of what population
they will primarily serve. Another commenter discussed the importance
of providing training on how to help patients access clinical trials.
One commenter recommended CMS require all auxiliary personnel
performing PIN services to have a bachelor's degree. Another commenter
recommended CMS require training in trauma-informed care, implicit
bias, empathetic inquiry, and motivational interviewing.
Response: We appreciate the suggestion of case studies and
condition-specific training, as we outlined in the proposed rule. While
we agree that PIN services are well-suited for oncology navigation, we
disagree with the idea that all auxiliary personnel providing PIN
services should be trained in oncology navigation, given that we expect
PIN services to be focused on the principal illness for which PIN
services are being furnished. We note that since we are finalizing PIN
services as ``per condition,'' rather than the patient only being able
to have one PIN service at a time, this crossover in navigation is
unnecessary, as a patient receiving PIN for one condition that gets
diagnosed with cancer would likely qualify for a second, oncology-
specific PIN navigator. Given the wide variety of suggestions we
received from commenters regarding the number of specific hours to
require, we believe that it is important for PIN services to allow for
many types of auxiliary personnel to furnish PIN, making potential
standardization of training and education requirements, such as a set
number of hours of training, difficult.
After consideration of public comments, we are not finalizing a
required number of hours of training for auxiliary personnel to provide
PIN services. We defer to State requirements
[[Page 78946]]
where applicable for all types of auxiliary personnel. For States with
no applicable State requirements, we are finalizing as proposed that
the training and certification for auxiliary personnel providing HCPCS
codes G0023 and G0024 include the competencies of patient and family
communication, interpersonal and relationship-building, patient and
family capacity building, service coordination and systems navigation,
patient advocacy, facilitation, individual and community assessment,
professionalism and ethical conduct, and the development of an
appropriate knowledge base, including specific certification or
training on the serious, high-risk condition/illness/disease addressed
in the initiating visit.
Comment: Regarding certified peer support specialists, we received
many comments regarding their training and certification requirements.
A few commenters stated that training and certification is required at
the State level in 49 States and that these requirements are sufficient
for Medicaid payment by states. Several commenters requested that CMS
not require any additional training for peer support specialists beyond
State certification, as that would be a burden on the workforce and the
agencies that employ them. A few commenters recommended that CMS
mandate training alignment with the SAMHSA National Model Standards for
the training of all peer support specialists, stating that these
standards were developed with direct input and feedback from peer
support workers themselves. These commenters discussed that it is
important for those who are doing peer support work to have input into
the training and certification standards for their profession.
Response: We note that a 2023 review of State requirements done in
partnership with SAMHSA cited that two States remain without current
peer support specialist certification or licensing requirements. One of
the remaining States is currently working on developing a
certification.\39\ We thank the commenters for the mention of the
National Model Standards, and we agree that we should aim to align
across the Federal government where possible.
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\39\ https://peerrecoverynow.org/wp-content/uploads/2023-FEB-07-prcoe-comp-analysis.pdf.
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After consideration of public comments, for PIN-PS (HCPCS codes
G0140 and G0146), if no applicable State requirements exist, we are
finalizing that training must be consistent with the National Model
Standards for Peer Support Certification published by SAMHSA. This is
the most universally recognized standard for peer support specialists
in the country and was developed and is maintained by SAMHSA, who has
an expertise in this area.
We proposed that time spent furnishing PIN services for purposes of
billing HCPCS codes G0023-4 must be documented in the medical record in
its relationship to the serious, high-risk illness. The activities
performed by the auxiliary personnel, and how they are related to the
treatment plan for the serious, high-risk condition, would be described
in the medical record, just as all clinical care is documented in the
medical record. We would require identified SDOH need(s), if present,
to be recorded in the medical record, and for data standardization,
practitioners would be encouraged to record the associated ICD-10 Z-
code (Z55-Z65) in the medical record and on the claim.
Similar to CHI services, we believe that many of the elements of
PIN services would involve direct contact between the auxiliary
personnel and the patient but may not necessarily be in-person and a
portion might be performed via two-way audio. We sought to confirm our
understanding of where and how PIN services would be typically provided
(for example, with or without direct patient contact, in-person, using
audio-video, using two-way audio; and whether navigators are typically
local to the patient).
We solicited public comment regarding whether we should require
patient consent for PIN services. For care management services that
could generally be performed without any direct patient contact, we
have required advance patient consent to receive the services as a
prerequisite to furnishing and billing the services, to avoid patients
receiving bills for cost sharing that they might not be expecting to
receive. For example, a patient might receive chronic care management
services comprised of practitioners coordinating care with each other
and reviewing or exchanging medical records between visits, in ways
that do not require involving the patient directly. As we have
frequently discussed in prior rulemaking for care management services
(for example, at 81 FR 80240), we do not have statutory authority to
waive cost sharing for care management or other services. Rather, cost
sharing remains applicable, except as specified by statute such as for
certain preventive services. In recent years, we have required advance
documented patient consent to receive most care management services as
a condition of the practitioner billing those services, to avoid a
situation where the patient is surprised to receive a bill for the
associated cost sharing. These consent requirements include informing
the patient about applicable cost sharing, the right to discontinue
services, and, where applicable, the limitation that payment is made
for the service to only one practitioner per month. We have heard from
interested parties over time that requiring advance patient consent is
an administrative burden and may unnecessarily prevent patient receipt
of needed services. We did not propose to require consent for PIN
services, since we believe these services typically would involve
direct patient contact, and largely be provided in-person. However, in
the proposed rule we stated that if we heard from public commenters
that PIN services would frequently not involve direct contact with the
patient, or could extend for periods of time for which the patient
might not be expecting to incur cost sharing obligations (such as
several months), we would consider requiring patient consent to receive
PIN services in our final rule.
We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: We received many comments regarding the use of two-way
audio or audio-video technology in the current practice of navigation
services. One commenter noted that the time required to provide
navigation services for each patient had dropped during the pandemic
when most of the communication switched to two-way audio or audio-
visual. Other commenters discussed that for patients in rural areas,
not requiring face-to-face contact in person reduced patient burden,
given that the individuals providing navigation services may not be
located in the exact community in which the patient live. This
commenter noted that in rural areas, navigators often cover a large
geographic area, but are still aware of community resources and all the
appropriate services throughout their catchment area. Several
commenters also discussed the importance of virtual communication for
patients who are immunocompromised. A few commenters requested that PIN
services be placed on the Medicare Telehealth Services List.
Response: We note that we did not receive comments directly
discussing the current amount of time spent each month furnishing
navigation services in person versus the amount of time spent using
telecommunications. We did not receive comments discussing the
[[Page 78947]]
amount of time navigators spend performing activities on behalf of the
patient without the patient being present. We also did not receive much
information regarding if there are elements of the navigation service
that are best served face-to-face or pieces that are just as impactful
if done via telecommunications technology. We agree with commenters
generally that PIN services will likely benefit from the use of two-way
audio or audio-visual technology as a key part of the service, but
based on the comments received, we do not believe that we have a
complete understanding of how technology is being used to furnish
navigation services currently. We also acknowledge that PIN services
(HCPCS codes G0023 and G0024) and PIN-Peer Support (HCPCS codes G0140
and G0146) may look different when they are being furnished. For
example, the wording on the service elements for PIN-PS is slightly
different, discussing that the navigator in PIN-PS ``assists the
patient in communicating'' with health care practitioners, rather than
communicating with the practitioners on behalf of the patient through
coordination activities. This may mean that the navigator for PIN-PS is
in direct contact with the patient more, as they are assisting the
patient in performing a task, rather than performing that task on
behalf of the patient. Given these intricacies and the lack of
specificity in the comments we received, we do not believe we can make
a determination at this time regarding whether or not PIN services meet
the standards of services that are inherently in-person services that
are instead furnished using an interactive telecommunications system as
described in Sec. 410.78(a)(3). Given these factors, we are not
finalizing the inclusion of PIN services (HCPCS codes G0023, G0024,
G0140, G0146) on the Medicare Telehealth Services List at this time. We
will continue to consider this issue for potential rulemaking in the
future.
Comment: In response to our comment solicitation, commenters were
overwhelmingly in favor of requiring patient consent for PIN services.
Many commenters cited patient cost sharing obligations, discussing both
the expected duration of PIN services over several months, as well as
the fact that some parts of the service may be provided without the
patient present. Several commenters encouraged CMS to require consent,
but noted potential burdens depending on how the consent is obtained,
especially when advance consent is required. Commenters urged CMS to
allow verbal consent to be documented in the medical record and to
allow auxiliary personnel to document it. One commenter that was not in
favor of requiring consent was concerned that a patient might not have
a clear understanding of their condition and expected course of
treatment at the beginning of a principal illness and is likely to be
overwhelmed with information. This commenter further clarified that
without adequate information, as well as potentially having concerns
regarding their financial responsibility for both their course of
treatment and any applicable cost-sharing for PIN, would decline PIN
services without fully understanding the costs and benefits of
navigation.
Response: We appreciate the commenters' thoughts about this issue.
We acknowledge that beneficiaries are dealing with a lot at the time
they are diagnosed with a principal illness, but we also acknowledge
that navigation services are a key part of helping beneficiaries manage
this difficult time. While we do not always require consent for all
medically necessary services, we have required consent on occasion when
services are being provided for a prolonged period of time and when
some of the service may be performed without the patient's presence. In
addition, the vast majority of commenters strongly supported the
requirement of consent to provide improved patient awareness of cost-
sharing responsibilities, especially given that these navigation
services may be expected to last several months.
After consideration of public comments, we are finalizing that
patient consent is required for PIN services, and that consent can be
written or verbal, so long as it is documented in the patient's medical
record. We believe that the commenters' feedback regarding the
potential duration of PIN services over multiple months, in addition to
the fact that PIN services may not be furnished with the patient
present is convincing evidence that patients should be aware of their
cost-sharing obligations over time for PIN services. We are finalizing
that consent must be obtained annually and may be obtained by the
auxiliary personnel either before or at the same time that they begin
performing PIN services for the patient.
We proposed that a practitioner may arrange to have PIN services
provided by auxiliary personnel who are external to, and under contract
with, the practitioner or their practice, such as through a community-
based organization (CBO) that employs CHWs or other auxiliary
personnel, if all of the ``incident to'' and other requirements and
conditions for payment of PIN services are met. Although we proposed to
allow PIN services to be performed by auxiliary personnel under a
contract with a third party, we clarify, as we have in our regulations
for other care management services, that there must be sufficient
clinical integration between the third party and the billing
practitioner in order for the services to be fully provided, and the
connection between the patient, auxiliary personnel, and the billing
practitioner must be maintained. As we discussed in a similar context
for care management services the CY 2017 PFS final rule, if there is
little oversight by the billing practitioner or a lack of clinical
integration between a third party providing the services and the
billing practitioner, we do not believe PIN services, as we proposed to
define them, could be fully performed; and therefore, in such cases,
PIN services should not be billed (81 FR 80249). We would expect the
auxiliary personnel performing the PIN services to communicate
regularly with the billing practitioner to ensure that PIN services are
appropriately documented in the medical record, and to continue to
involve the billing practitioner in evaluating the continuing need for
PIN services to address the serious, high-risk condition.
In the CY 2023 PFS final rule (87 FR 69790) and as explained in the
CY 2023 PFS proposed rule (87 FR 46102), where we refer to community-
based organizations, we mean public or private not-for-profit entities
that provide specific services to the community or targeted populations
in the community to address the health and social needs of those
populations. They may include community-action agencies, housing
agencies, area agencies on aging, centers for independent living, aging
and disability resource centers or other non-profits that apply for
grants or contract with healthcare entities to perform social services.
As described earlier, they may receive grants from other agencies in
the U.S. Department of Health and Human Services, including Federal
grants administered by the Administration for Children and Families
(ACF), Administration for Community Living (ACL), the Centers for
Disease Control and Prevention (CDC), the Substance Abuse and Mental
Health Services Administration (SAMHSA), or State-funded grants to
provide social services. Generally, we believe such organizations know
the populations and communities they serve and may have the
infrastructure or systems in place to assist practitioners to provide
PIN
[[Page 78948]]
services. We understand that many CBOs provide social services and do
other work that is beyond the scope of PIN services, but we believe
they are well-positioned to develop relationships with practitioners
for providing reasonable and necessary PIN services.
We proposed that only one practitioner per beneficiary per calendar
month could bill for PIN services for a given serious, high-risk
condition, because we are concerned about potential care fragmentation
if the patient has more than one navigator for their condition during a
given month. Our proposal would allow the patient to have a single
point of contact for navigation of their condition.
We proposed that the practitioner could bill separately for other
care management services during the same month as PIN, if time and
effort are not counted more than once, requirements to bill the other
care management services are met, and the services are medically
reasonable and necessary.
Similar to CHI services discussed previously in this final rule,
there are aspects of PIN services, or PIN services for certain
conditions, that may be covered under a Medicaid State plan. When
Medicare and Medicaid cover the same services for patients eligible for
both programs, Medicare generally is the primary payer in accordance
with section 1902(a)(25) of the Act. We sought public comment regarding
whether States typically cover services similar to PIN under their
Medicaid programs, and whether such coverage would be duplicative of
the PIN service codes. We also solicited comment on whether there are
other service elements not included in the PIN service codes that are
part of associated care that should be included in the PIN service
codes, or are important in navigation for high-risk conditions, where
CMS should consider coding and payment in the future. For example, are
there circumstances when clinical navigators, under the supervision of
another professional, typically spend time face-to-face with patients
that the PIN services codes, as currently described, may not fully
account for?
We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: Many commenters appreciated our mention of CBOs, and these
commenters outlined the benefits of external partnerships to increase
the capacity of practitioners to furnish services such as PIN. A few
commenters noted that there are geographic areas with a limited
presence of CBOs, and they were hopeful that increased reimbursement
opportunities through PIN would increase the supply of CBOs able to
work in this space. A few commenters requested clarification on what
``sufficient clinical integration'' means in this context, while a few
other commenters discussed that CBOs often lack the funding to be
integrated with electronic health records that may be used by
practitioners in their area.
Response: We reiterate that regular communication between the
patient, auxiliary personnel, and billing practitioner is essential to
ensure that everyone is involved in the patient's ongoing care.
Documentation of the PIN services furnished in relation to the serious,
high-risk condition in the medical record is required to track a
patient's progress through the diagnosis and treatment of their
principal illness, describe the interventions and PIN service elements
performed, and to describe the medical necessity of PIN services to the
principal illness. Documentation is also required to describe the
ongoing need or changes to the treatment plan that allow for the
cessation of PIN services; we appreciate that CBOs may not have access
to the electronic health record in which the furnishing practitioner is
documenting the patient's care in the medical record. To reduce
administrative burden, we are not requiring that all auxiliary
personnel performing PIN services must document the services in the
medical record themselves. Rather, the billing practitioner is
responsible for ensuring appropriate documentation of the PIN services
provided to the patient is included in the medical record.
Comment: Many commenters requested clarity on our proposed
requirement that PIN services can be furnished by one practitioner per
beneficiary per month for a serious, high-risk condition. These
commenters asked if the limit was by practitioner, meaning
beneficiaries could get one PIN service per practitioner or if each
beneficiary could only get one PIN service for all conditions.
Commenters noted that a patient may be receiving PIN for one condition
and while receiving PIN services, get diagnosed with another illness or
condition that also meets PIN criteria. A few commenters discussed that
some types of navigation services, like oncology navigation, are highly
condition-specific, and suggested that if a patient could only get PIN
services from one practitioner for one condition per month, oncology
navigators may not believe it within their skills and training to
provide PIN services for other conditions. Other commenters mentioned
that the enhanced value of navigation services in which the auxiliary
personnel have lived experience or training specific to the serious
high-risk condition and suggested that having the same navigators
perform PIN services for conditions other than those in which they have
training or lived experience would likely be detrimental to the
treatment of those conditions. Commenters also discussed the
operational difficulties of knowing whether the patient is receiving
PIN services for another condition.
Lastly, commenters were overwhelmingly in favor of our proposal to
allow PIN services to be billed in conjunction with other care
management codes. Commenters noted that patients who are likely to
receive PIN may also have comorbidities that are best managed through
care management codes, and practitioners should not have to choose
between PIN and other care management activities.
Response: Our intention in the proposed rule was to limit PIN
services to one per month per beneficiary, as we were concerned about
care fragmentation. We do not believe that having multiple navigators
for each condition is conducive to the patient's experience, and we
believe that the patient should generally have a single point of
contact when navigating a principal illness. However, we understand
that patients can have multiple principal illnesses at a time. We also
understand that some types of navigation, such as peer support and
oncology navigation are very condition-specific, which we continue to
believe is a benefit of PIN services. Also, as discussed previously in
this rule, we are not requiring auxiliary personnel furnishing PIN
services to be versed in every principal illness for which a patient
needs PIN services. However, we are also concerned about the
duplication of time and effort if the same practitioner bills two kinds
of PIN services for the same beneficiary. For example, a primary care
physician might be providing PIN services to a patient for one serious,
high-risk condition, and then the patient gets diagnosed with another
high-risk condition that is also being managed by the same primary care
physician. In this instance, the same navigator working incident to
this primary care physician would be unable to fully perform the PIN
service elements without duplicating time and effort, and therefore,
the primary care physician can only provide PIN services once per month
for this beneficiary.
We appreciate the commenters' support for our proposal to allow PIN
[[Page 78949]]
services to be billed with other care management codes. We aimed to
provide maximum flexibility to practitioners to choose the right type
of service for each of their patient's needs, and we agree with
commenters that if a patient has chronic or comorbid conditions that
are well-managed with a care management code and is then diagnosed with
a principal illness, it makes the most sense to provide that patient
with care management plus PIN.
After consideration of public comments, we are finalizing that PIN
services can be provided more than once per practitioner per month for
any single serious high-risk condition, to avoid duplication of PIN
service elements when utilizing the same navigator or billing
practitioner. We are also clarifying that PIN and PIN-PS should not be
billed concurrently for the same serious, high-risk condition. However,
practitioners furnishing PIN services may bill care management services
as appropriate for managing and treating a patient's illness. We remain
concerned about care fragmentation should patients receive multiple PIN
services for different high-risk conditions. We believe that PIN is
best suited for situations in which the navigator can serve as a point
of contact for the patient. Given this, we do not expect a patient to
require multiple PIN services for a prolonged period of time, except in
circumstances in which a patient is receiving PIN services for highly
specialized navigation, such as behavioral health or oncology. Lastly,
we are finalizing, as proposed, that PIN services can be furnished in
addition to other care management services as long as time and effort
are not counted more than once, requirements to bill the other care
management services are met, and the services are medically reasonable
and necessary.
iii. PIN Services Valuation
For HCPCS code G0023, we proposed a work RVU of 1.00 based on a
crosswalk to CPT code 99490 (Chronic care management services with the
following required elements: multiple (two or more) chronic conditions
expected to last at least 12 months, or until the death of the patient,
chronic conditions that place the patient at significant risk of death,
acute exacerbation/decompensation, or functional decline, comprehensive
care plan established, implemented, revised, or monitored; first 20
minutes of clinical staff time directed by a physician or other
qualified health care professional, per calendar month) as we believe
these values most accurately reflect the resource costs associated when
the billing practitioner performs PIN services. CPT code 99490 has an
intraservice time of 25 minutes and the physician work is of similar
intensity to our proposed HCPCS code G0023. Therefore, we proposed a
work time of 25 minutes for HCPCS code G0023 based on this same
crosswalk to CPT code 99490. We proposed using this crosswalk to
establish the direct PE inputs for HCPCS code G0023.
For HCPCS code G0024, we proposed a crosswalk to the work RVU and
direct PE inputs associated with CPT code 99439 (Chronic care
management services with the following required elements: multiple (two
or more) chronic conditions expected to last at least 12 months, or
until the death of the patient, chronic conditions that place the
patient at significant risk of death, acute exacerbation/
decompensation, or functional decline, comprehensive care plan
established, implemented, revised, or monitored; each additional 20
minutes of clinical staff time directed by a physician or other
qualified health care professional, per calendar month (List separately
in addition to code for primary procedure)) as we believe these values
reflect the resource costs associated with the clinician's direction of
clinical staff who are performing the PIN services. Therefore, we
proposed a work RVU of 0.70 and a work time of 20 minutes for HCPCS
code G0024.
Comment: Commenters generally supported the proposed crosswalk to
the Chronic Care Management services and our proposed valuation.
Commenters agreed that the RVU for HCPCS code G0023 should have a work
RVU of 1.00 based on the crosswalk to CPT code 99490 but the RVU
crosswalk should not be limited to the first 20 minutes of PIN services
and each subsequent 20 minutes should have its own code. We did not
receive any comments regarding the proposed crosswalk for HCPCS code
G0024.
Response: We thank the commenters for their feedback. We believe
the commenters have misunderstood our crosswalk. While CPT code 99490
is broken down into 20-minute blocks of time, we do not believe that 20
minutes is sufficient per month to be spent on PIN services, as
discussed above. We clarify that the RVU crosswalk for 60 minutes per
month of CPT code 99490 has an intraservice time of 25 minutes, and has
a work RVU of 1.00, so the valuation for 60 minutes per month of time
is equal between CPT codes 99490 and G0023.
After consideration of public comments, we are finalizing the
crosswalks for HCPCS codes G0023 and G0024 as proposed, with HCPCS code
G0023 being directly crosswalked with CPT code 99490 at work RVU of
1.00, 25 minutes of intraservice time and matching direct PE inputs. We
are also finalizing a direct crosswalk between HCPCS code G0024 and CPT
code 99439, with a work RVU of 0.70, a work time of 20 minutes, and
matching direct PE inputs. While we note that PIN-PS does not contain
all descriptor elements to the original PIN service, we believe that
the core elements of PIN are preserved in PIN-PS, and that the
activities and service elements described in PIN-PS represent equal
time and intensity to the PIN codes and CPT codes 99490 and 99439,
respectively. The PIN-PS codes are targeted for specific work performed
by auxiliary staff such as peer support specialists, and since this is
a timed code, we believe that 60 minutes of time spent per month by
auxiliary staff, including 25 minutes of intraservice time for the
physician or billing practitioner is unchanged, even if the code
descriptors vary slightly. Therefore, we are finalizing the crosswalk
to CPT code 99490 for HCPCS code G0140 and CPT code 99439 for HCPCS
code G0146.
(29) Maternity Services (CPT Codes 59400, 59410, 59425, 59426, 59430,
59510, 59515, 59610, 59614, 59618, 59622)
In the CY 2021 PFS final rule with comment period (85 FR 84554 and
84555), we finalized our proposal to revalue the bundled maternity
codes used to bill for delivery, antepartum, and postpartum maternity
care services to account for increases in the values of office/
outpatient E/M services. These codes are all designated with a unique
global period indicator ``MMM.'' There are 11 MMM codes that include E/
M visits as part of their valuation.
For CY 2024, we proposed to update the work RVUs and work times of
these MMM codes to reflect any relevant E/M updates associated with
their global periods that were finalized in CY 2023. Table 13 contains
a list of these codes and the proposed work RVUs for CY 2024. MMM codes
are unique within the PFS in that they are the only global codes that
provide a single payment for almost 12 months of services, which
include a relatively large number of E/M visits performed along with
delivery services and imaging; and were valued using a building-block
methodology as opposed to the magnitude estimation method.
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Comment: Several commenters stated that they supported CMS'
proposal to update the maternity codes to account for the increases in
the office and hospital visits bundled into their global period and
agreed that the work RVU increases were correct. However, the
commenters stated that the total work times incorporating both the
increases in office visits and hospital visits into the global periods
for these maternity services were not correct; the commenters
recommended that CMS fix this technical error when calculating the time
increases in the global periods for the maternity services and
submitted a spreadsheet detailing the correct work times.
Response: We appreciate the support for our proposed policies from
the commenters, as well as alerting us to this potential technical
error in the updated work times for the maternity services codes. After
reviewing the additional information provided by the commenters, we
discovered that the incorrect work time values for the maternity
services codes were used in calculating the payment rates due to a
technical error. We will correct these codes with their updated work
times for the final rule.
After consideration of the public comments, we are finalizing our
proposal to update the work RVUs and work times of these MMM codes to
reflect any relevant E/M updates associated with their global periods
that were finalized in CY 2023, as detailed in Table 13.
BILLING CODE 4120-01-P
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BILLING CODE 4120-01-C
F. Evaluation and Management (E/M) Visits
1. Background
Over the past several years, we have engaged in a multi-year effort
with the American Medical Association (AMA) and other interested
parties to update coding and payment for evaluation and management (E/
M) visits, so that they better reflect the current practice of
medicine, are less administratively complex, and are paid more
accurately under the PFS. This work is critical to improve payment
accuracy and help reduce practitioner burnout.
E/M visits comprise approximately 40 percent of all allowed charges
under the PFS. The office/outpatient (O/O) E/M visits comprise
approximately half of these allowed charges (approximately 20 percent
of total PFS allowed charges), and Other E/M visits (such as inpatient/
observation visits, nursing facility visits and home/residence visits)
comprise the other half (approximately 20 percent of total PFS allowed
charges). As we have discussed in prior rules, within the E/M services
represented in these percentages, there is wide variation in the volume
and level of E/M visits billed by different specialties (84 FR 62844).
According to Medicare claims data, E/M visits are furnished by nearly
all specialties but represent a greater share of total allowed services
for physicians and other practitioners who do not routinely furnish
procedural interventions or diagnostic tests. Accordingly, our policies
for revaluation of E/M visits have a significant impact on relative
resource valuation under the PFS, which could potentially impact
patient care more broadly.
In this section of our final rule, we continue our work to address
two outstanding issues in E/M visit payment: implementing separate
payment for the O/O E/M visit complexity add-on code for separate
payment, and our definition of split (or shared) visits, which we
delayed last year.
For CY 2018, we solicited public comment regarding how we could
comprehensively reform the E/M documentation guidelines to reduce
administrative and clinical burden, improve payment accuracy, and
better align E/M coding and documentation with the current practice of
medicine (82 FR 34078 and 34079, 82 FR 53163). We believed that the
documentation requirements for history and physical exam were
particularly outdated clinically and that medical decision making (MDM)
and time were the more significant factors in distinguishing visit
levels (82 FR 53164). Public commenters recommended a transparent,
iterative, and perhaps transitional approach, and some commenters
suggested that CMS and the AMA should also undertake revision and
revaluation of the E/M visit code set itself, in addition to updating
the documentation guidelines (82 FR 53165). Having reviewed the public
comments, we noted they illustrated how difficult it is to utilize or
rely upon such a relatively small set of codes to describe and pay for
the work of a wide range of physicians and practitioners in many vastly
different clinical contexts; that E/M documentation guidelines were not
simply a matter of administrative burden, but were also clinically
outdated and intimately related to the definition and description of E/
M work as well as valuation; and that there were different opinions on
potential redefinition and revaluation of the E/M code set depending on
practitioner specialty, and the type of
[[Page 78969]]
work dominating the specialty (for example, primary care, so-called
``cognitive'' specialty work, or global procedures that have E/M visits
bundled in rather than separately performed and documented) (82 FR
53165). We stated that we would continue working on these issues with
interested parties in future years.
Because we agreed with commenters that we should take an
incremental approach to these issues, the following year we proposed
changes largely limited to the O/O E/M visit code family (83 FR 59628).
In our CY 2019 PFS final rule, we finalized documentation changes, some
of which took effect in CY 2019 (83 FR 59628 through 59535), while
others (notably choice of MDM or time for supporting documentation)
would be effective in CY 2021 in conjunction with finalized coding and
payment changes for O/O E/M visits (83 FR 59636 through 59645). The
coding and payment changes included a single payment rate for levels 2
through 4 O/O E/M visits (retaining separate payment for level 5 visits
to account for the most complex patients and visits); two HCPCS add-on
codes to provide separate, additional payments for the resource costs
involved in furnishing certain types of O/O E/M visit care,
specifically visit complexity inherently associated with primary care
and non-procedural specialty care; and a third HCPCS code for O/O E/M
visits taking extended amounts of time (83 FR 59638).
In January and February 2019, we held listening sessions, and we
learned that the AMA was convening an E/M Workgroup to develop an
alternative solution to some of these issues (84 FR 40673). The AMA
revised and resurveyed the O/O E/M visit code family (see 84 FR 62844
through 62847). Effective January 1, 2021, the CPT Editorial Panel
redefined the codes for O/O E/M visits such that the furnishing
practitioner may select the level of visit to bill based either on the
amount of practitioner time spent performing the visit or the level of
medical decision-making (MDM) involved. The CPT Editorial Panel
redefined MDM in the CPT E/M Guidelines, which are an accompanying set
of CPT interpretive guidelines delineating different levels of MDM and
various other reporting parameters. Additionally, history of present
illness (History) and a physical exam were no longer used to select the
O/O E/M visit level. These service elements were updated to remove
reliance on clinically outdated parameters to contribute to the
selection of visit level, such as number of body systems reviewed, and
to require a medically appropriate history and exam instead. Also,
effective January 1, 2021, the CPT Editorial Panel revised the O/O E/M
visit descriptor times. Previously, the CPT code descriptors included
typical service times, but they were revised to specify new time ranges
that must be furnished in order to select a given visit level using
time. The AMA RUC resurveyed the O/O E/M visit CPT codes, and provided
us with revaluation recommendations that we then addressed in our CY
2020 PFS proposed rule, a year in advance of when the revised codes
would take effect in CY 2021 (84 FR 40675 through 40678).
In our CY 2020 PFS final rule, we generally adopted the revised O/O
E/M code set and the related changes in the CPT E/M Guidelines,
including the revised approach to visit level selection and
documentation, for payment purposes under the PFS effective January 1,
2021 (84 FR 62844 through 62859). While we accepted the revised CPT
codes and approach for the O/O E/M visits, we finalized Medicare-
specific coding for prolonged O/O service codes, because we were
concerned that the CPT codes were administratively complex, and their
use would have impacted our ability to tell how much total time was
spent with the patient and could have resulted in inappropriately
inflated payment (84 FR 62849 through 62850, and 85 FR 84572 through
84575).
In our CY 2020 PFS final rule, we generally accepted the RUC
recommendations, which reflected increased service times (84 FR 62851
through 62854). This resulted in increased values for the O/O E/M visit
codes beginning in CY 2021. However, since we believed these increased
valuations still did not account for the resources involved in
furnishing certain kinds of care included in the O/O E/M visit code
set, in the CY 2021 PFS final rule, we retained our add-on codes for
visit complexity inherently associated with primary care and non-
procedural specialty care, though we refined and consolidated them into
a single code, a HCPCS add-on code G2211 (O/O E/M visit complexity)
that can be reported in conjunction with O/O E/M visits to better
account for additional resources associated with primary care, or
similarly ongoing medical care related to a patient's single, serious
condition, or complex condition (84 FR 62854 through 62856, 85 FR
84571). (Hereafter in this rule, we refer to this code as the O/O E/M
visit complexity add-on).
After we issued the CY 2021 PFS final rule, section 113 of Division
CC of the Consolidated Appropriations Act, 2021 (Pub. L. 116-260,
December 27, 2020) (CAA, 2021) imposed a moratorium on Medicare payment
for this service by prohibiting CMS from making payment under the PFS
for services described by HCPCS code G2211 (or any successor or
substantially similar code) before January 1, 2024. Accordingly, the O/
O E/M visit complexity add-on code can be reported, but it is currently
assigned a bundled payment status indicator. See our fact sheet
available at Physician Fee Schedule (PFS) Payment for Office/Outpatient
Evaluation and Management (E/M) Visits--Fact Sheet \40\ (cms.gov).
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\40\ https://www.cms.gov/files/document/physician-fee-schedule-pfs-payment-officeoutpatient-evaluation-and-management-em-visits-fact-sheet.pdf.
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In the CY 2022 PFS final rule, we established revised payment rules
for split (or shared) visits (86 FR 65150 through 65159). The following
year the CPT Editorial Panel defined a split (or shared) visit for the
first time in the CPT E/M Guidelines for 2023. However, we did not
adopt the CPT definition as it did not conform with our established
final policy or address which practitioner should report a shared
visit.
For CY 2023, the CPT Editorial Panel also revised the rest of the
E/M visit code families (except critical care services) to match the
general framework of the O/O E/M visits, including inpatient and
observation visits, emergency department (ED) visits, nursing facility
visits, domiciliary or rest home visits, home visits, and cognitive
impairment assessment. We referred to these other E/M visit code
families as ``Other E/M'' visits or CPT codes, as relevant. Effective
January 1, 2023, the CPT Editorial Panel redefined the Other E/M visits
so that they parallel the O/O E/M visits, where visit level is selected
based on the amount of practitioner time spent with the patient or the
level of MDM as redefined in the CPT E/M Guidelines. As for the O/O E/M
visits, a medically appropriate history and/or physical exam is a
required element of the services but no longer impacts the Other E/M
visit level. The CPT Editorial Panel also revised the service times
within the descriptors, the associated CPT prolonged service codes, and
the CPT E/M Guidelines for the Other E/M CPT codes. The CPT Editorial
Panel also consolidated many of the Other E/M CPT codes, with inpatient
and observation visits combined into a single code set and home and
domiciliary visits combined into a single code set. The CPT Editorial
Panel created one new CPT code for prolonged inpatient services by
physicians and other qualified healthcare professionals on the date of
[[Page 78970]]
the E/M visit. Finally, the RUC resurveyed the Other E/M visits and
associated prolonged service codes and provided revaluation
recommendations to CMS.
We addressed these changes to the Other E/M visit families in the
CY 2023 PFS final rule (87 FR 69586 through 69616). In that final rule,
we adopted the revised CPT codes and descriptors for Other E/M visits,
except for prolonged services for which we finalized Medicare-specific
coding. We also adopted the CPT E/M Guidelines for levels of MDM as
revised for 2023. Regarding valuation, we adopted most of the RUC-
recommended values for Other E/M visits, increasing their relative
valuation in aggregate. However, we believe that certain types of O/O
E/M visits remain undervalued, given the moratorium on separate payment
for the O/O E/M visit complexity add-on (87 FR 69588). We expressed
concern about assumptions made in the RUC recommendations for Other E/M
visits that patient needs were inherently more complex, or work was
more intense for E/M visits furnished in non-office settings (for
example, inpatient, ED, and home settings) when compared to the office
settings (87 FR 69587 through 69588). We stated that this direct
comparison between Other E/M visits and the O/O E/M visit codes may not
be appropriate or accurate, and laid out reasons why practitioners in
office settings may expend more resources than practitioners in
institutional and other settings. We noted that the survey times for O/
O E/M visits increased significantly when resurveyed (85 FR 50123),
while times for Other E/M visits generally decreased significantly or
remained the same when resurveyed, despite the level of MDM remaining
constant (87 FR 69598, 69605). To the extent we adopted the RUC-
recommended values for Other E/M visits beginning in CY 2023, we
expressed that we did not agree that the RUC-recommended relative
values for E/M visits fully accounted for the complexity of certain
kinds of visits, especially for those in the office setting, nor do
they fully reflect appropriate relative values, since separate payment
is not yet made for the O/O E/M visit complexity add-on (87 FR 69588).
During the CAA, 2021 moratorium on separate payment for the O/O E/M
visit complexity add-on, interested parties have continued to engage
CMS about the appropriate valuation of O/O E/M visits relative to other
PFS services, including through public comments on the proposed
revaluation of Other E/M visits (87 FR 70218), as well as in meetings
and letters submitted to CMS outside of the rulemaking process.
Anticipating the end of the CAA, 2021 moratorium, interested parties,
including the AMA, several medical associations, and others, recently
approached CMS outside of the rulemaking process with recommendations
regarding implementation and potential refinements to the service
beginning in 2024 to ensure the appropriate relative valuation of O/O
E/M visits. Interested parties have also continued to approach CMS and
the CPT Editorial Panel with questions and recommendations about
payment rules for split (or shared) visits.
2. Office/Outpatient (O/O) E/M Visit Complexity Add-On Implementation
a. Background
As discussed above, in the CY 2021 PFS final rule, CMS refined the
O/O E/M visit complexity add-on code, GPC1X (which was replaced by
HCPCS code G2211), to describe intensity and complexity inherent to O/O
E/M visits associated with medical care services that serve as the
continuing focal point for all needed health care services and/or with
medical care services that are part of ongoing care related to a
patient's single, serious, or complex condition. (85 FR 84569 through
84571). While we adopted the AMA RUC recommendations for the revised O/
O E/M CPT visit codes, those values did not fully account for the
resource costs associated with primary care and other longitudinal care
of complex patients. Under our final policy, which was delayed by the
CAA, 2021 before it was implemented, the O/O E/M visit complexity add-
on code could be reported with all O/O E/M visit levels. We disagreed
with comments suggesting that billing of the O/O E/M visit complexity
add-on code should be restricted to higher level office/outpatient E/M
visits; and responded that, given the wide variety of visit types
billable with the office/outpatient E/M visit code set, we did not
believe that the value associated with the typical visit accounts for
the additional resources associated with primary care or ongoing care
related to a patient's single, serious, or complex chronic condition,
regardless of the visit level. The full descriptor for the O/O E/M
visit complexity add-on code, as refined in the CY 2021 PFS final rule,
is HCPCS code G2211 (Visit complexity inherent to evaluation and
management associated with medical care services that serve as the
continuing focal point for all needed health care services and/or with
medical care services that are part of ongoing care related to a
patient's single, serious condition or a complex condition. (Add-on
code, list separately in addition to office/outpatient evaluation and
management visit, new or established)) (85 FR 84571) We also estimated
that the O/O E/M visit complexity add-on service would be reported by
specialties that rely on office/outpatient E/M visits to report the
majority of their services and would be billed in addition to those E/M
visits. While we did not explicitly prohibit billing the O/O E/M visit
complexity add-on in conjunction with visits that are reported with
various modifiers, and did not exclude those from our utilization
estimates, we stated we did not expect the add-on service to be
reported for visits billed with a payment modifier, for example, to
identify a separately billable E/M visit in conjunction with a minor
procedure (85 FR 84571 through 84572). We stated that visits reported
with payment modifiers are likely to involve resources distinct from
the stand-alone O/O E/M visits for primary care and other longitudinal
care of complex patients, and that we may consider this issue in future
rulemaking. We further stated that we do not expect the O/O E/M visit
complexity add-on code to be reported when the O/O E/M visit is
reported with payment modifiers such as modifier -25 which describes
separately billed visits on the same day as another visit or procedure
(see our fact sheet, identifying additional modifiers, available at
Physician Fee Schedule (PFS) Payment for Office/Outpatient Evaluation
and Management (E/M) Visits--Fact Sheet (cms.gov)).
Interested parties have continued to express uncertainty about when
reporting the O/O E/M visit complexity add-on service would be
appropriate. Some interested parties have expressed larger concerns
about potential reductions to the PFS CF or redistributive impacts
among specialties if we were to implement the O/O E/M visit complexity
add-on code. In the CY 2021 PFS final rule, we clarified and refined
the service definition to alleviate some of these concerns and revised
our utilization estimates (85 FR 84572). Conversely, some interested
parties, specifically practitioners who rely on office/outpatient E/M
visits to report the majority of their services, who could use the add-
on code to better reflect the resources they use to furnish complex
longitudinal services, expressed continued support for our policy. We
reiterated our belief that the O/O E/M visit complexity add-on reflects
the time, intensity, and PE resources involved when practitioners
furnish the
[[Page 78971]]
kinds of O/O E/M office visit services that enable them to build
longitudinal relationships with all patients (that is, not only those
patients who have a 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. In response to
comments, we also made further refinements to the HCPCS code descriptor
to clarify that the code applies to a serious condition rather than any
single condition. We also acknowledged concerns that given the request
by some medical societies for additional time to educate their members
about the appropriate use of the O/O E/M visit complexity add-on code,
ongoing implementation of the revisions to the O/O E/M visit code set,
electronic health records integration, and the persistence of the
COVID-19 pandemic, practitioners that rely on O/O E/M visits to report
the majority of their services are not likely to report the complexity
add-on code with every office visit. However, we disagreed with
commenters who thought the O/O E/M visit complexity add-on code would
be billed with only 10 to 25 percent of O/O E/M services. Because we
had not implemented any additional policies that restricted the billing
of this code, we estimated that the add-on code would be billed with 90
percent of O/O E/M visits billed by certain physician specialties
(roughly 58 percent of all office/outpatient E/M visits).
b. O/O E/M Visit Complexity Add-On HCPCS Code G2211
Interested parties have continued to engage with us and provide
recommendations for implementing the O/O E/M visit complexity add-on.
Some commenters recommended that CMS delay the implementation of HCPCS
add-on code G2211, citing concerns about the expected budget neutrality
adjustment necessitated by implementing the O/O E/M visit complexity
add-on and redistributive impact on PFS payment (85 FR 84572). Many
commenters who rely upon O/O E/M visits to report most of their
services continued to support HCPCS add-on code G2211 (85 FR 84570) and
have recommended that we speedily implement it. Some commenters also
suggested ways to clarify the intended use of the O/O E/M visit
complexity add-on code, which could reduce redistributive impacts.
Finally, as noted above, the values we established for the revised O/O
E/M CPT codes in the CY 2021 PFS final rule were finalized in concert
with a policy that would have provided separate payment for the new
add-on code G2211 (87 FR 69588). To the extent we adopted the RUC-
recommended values for Other E/M visits beginning in CY 2023, we
expressed that we did not agree that the RUC-recommended relative
values for E/M visits fully reflected appropriate relative values,
since separate payment is not yet made for HCPCS code G2211.
The CAA, 2021 moratorium on Medicare payment under the PFS for
HCPCS code G2211 will end on December 31, 2023. We proposed to change
the status of HCPCS code G2211 to make it separately payable by
assigning it an ``active'' status indicator, effective January 1, 2024.
After considering the feedback from interested parties, both through
the CY 2021 PFS rulemaking process and during the moratorium, we also
proposed several policy refinements (with respect to HCPCS code G2211).
We stated in the CY 2021 PFS final rule that we would not expect HCPCS
add-on code G2211 to be reported when the O/O E/M service is reported
with a payment modifier, such as the modifier-25, which denotes a
separately billable E/M service by the same practitioner furnished on
the same day of a procedure or other service (85 FR 84572). We continue
to believe that separately identifiable O/O E/M visits occurring on the
same day as minor procedures (such as zero-day global procedures) have
resources that are sufficiently distinct from the costs associated with
furnishing stand-alone O/O E/M visits to warrant different payment (85
FR 84572). As such we proposed that the O/O E/M visit complexity add-on
code, HCPCS code G2211, would not be payable when the O/O E/M visit is
reported with payment modifier-25.
Interested parties have also requested that we reconsider our
previous utilization assumptions. In the CY 2021 PFS final rule, we had
assumed that specialties that rely on O/O E/M visit codes to report the
majority of their services would be most likely to report the O/O E/M
visit complexity add-on code and that they would report the add-on code
with every O/O E/M visit they report. We acknowledged commenters'
concerns that, given the request by some medical societies to educate
their members about appropriate use, and ongoing implementation of the
revisions to the office/outpatient E/M visit code set and electronic
health records integration, practitioners that rely on office/
outpatient E/M visits to report the majority of their services would
not be likely to report HCPCS code G2211 with every O/O E/M visit they
report (85 FR 84572).
Interested parties have presented persuasive reasons that such
practitioners would not be likely to report HCPCS code G2211 with every
O/O E/M visit they report. They reasoned that many practitioners
delivering care in settings specifically designed to address acute
healthcare needs, without coordination or follow-up, will regularly
have encounters with patients that are not part of continuous care.
Furthermore, in contrast to situations where the patient's overall,
ongoing care is being managed, monitored, and/or observed by a
specialist for a particular disease condition, we continue to believe
that there are many visits with new or established patients where the
O/O E/M visit complexity add-on code would not be appropriately
reported, such as when the care furnished during the O/O E/M visit is
provided by a professional whose relationship with the patient is of a
discrete, routine, or time-limited nature; such as, but not limited to,
a mole removal or referral to a physician for removal of a mole; for
treatment of a simple virus; for counseling related to seasonal
allergies, initial onset gastroesophageal reflux disease; treatment for
a fracture; and where comorbidities are either not present or not
addressed, and/or when the billing practitioner has not taken
responsibility for ongoing medical care for that particular patient
with consistency and continuity over time, or does not plan to take
responsibility for subsequent, ongoing medical care for that particular
patient with consistency and continuity over time (85 FR 84570 and
84571).
These considerations taken together with our proposal that the O/O
E/M visit complexity add-on code, HCPCS code G2211, would not be
payable when the O/O E/M visit is reported with payment modifier-25
have informed our revised utilization assumptions. Considering the
comments received by interested parties, and the reasons discussed
above, we now estimate that HCPCS code G2211 will be billed with 38
percent of all O/O E/M visits initially. We calculated these revised
utilization assumptions by considering the uptake of new codes in prior
years and the O/O E/M billing patterns of all specialties.
Specifically, we took into account the likelihood that primary care
specialties will have a higher utilization of the add-on code than
other specialties, surgical specialties will have the lowest
utilization since they are less likely to establish longitudinal care
relationships with patients, and other specialists are more likely to
have
[[Page 78972]]
longitudinal care relationships than surgical specialties but less
likely than primary care specialists. We also revised our estimates by
excluding (1) claims from practitioners participating in CMS capitated
models and (2) claims for established patient visits performed by
certain specialties that are unlikely to have a longitudinal care
relationship with a beneficiary. We also accounted for the number of
visits billed that were furnished as consults or to obtain a second
clinical opinion and excluded these types of visits from our estimates.
We estimated that HCPCS code G2211 could be billed with 54 percent of
all O/O E/M visits when fully adopted. This fully adopted estimate was
informed by considering the uptake of new codes after several years. We
sought comment on these utilization assumptions and the application of
this proposed policy for CY 2024.
We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: MedPAC appreciated our continued focus on ensuring that
primary care clinicians and other clinicians who primarily furnish E/M
services are accurately and appropriately paid. MedPAC also stated that
longstanding misvaluations in the fee schedule that have had a
detrimental impact on accurate primary care valuation, focusing on the
overvaluation of non-E/M services.
However, MedPAC did not support the agency's proposed approach to
establish payment for the add-on code because, in their view (similar
to some other commenters), there continues to be too much ambiguity
regarding the code's use and the resource costs it is intended to
reflect. MedPAC and other commenters expressed concern that without
further clarification, the code would likely be misused and could
potentially duplicate payments for other services. MedPAC noted that
CMS had added several services that describe services related to the
provision of longitudinal, comprehensive care, including care
management or other non-face-to-face services (for example, chronic
care management (CCM), principal care management (PCM), responding to
patient portal messages, and remote patient monitoring (RPM)).
Similarly, many commenters also questioned how the proposed complexity
add-on code would reflect additional work intensity resulting from
concurrently addressing multiple health complaints in a single visit,
additional clinical staff time or supplies expended during a visit, or
additional non-face-to-face activities associated with furnishing
comprehensive, longitudinal care. Some commenters went further to
assert that the code is duplicative and stated that the selection of
visit level by medical decision making (MDM) and/or total time on the
date of the encounter is flexible enough to address patient visit
complexity requiring unusual resources.
Response: We appreciate the concerns raised by MedPAC and the other
commenters. We strongly agree with MedPAC and others who state it is
important to clarify what specific additional resources this code would
better account for compared to the current available coding and
associated valuations, including of care management services, prolonged
services, and other non-face-to-face services. As proposed, the
inherent complexity code would address what we believe are longstanding
issues with coding and valuation of O/O E/M services that do not fully
distinguish and account for resource costs for primary care and other
longitudinal care for complex patients, but specifically for visits
associated with longitudinal, non-procedural care when compared to work
RVUs for procedural services and visits furnished in association with
procedural-based care. We believe that because E/M visit codes are
intended to be used very broadly, the complexity of services required
to provide this type of care is not fully incorporated as part of the
valuation of the work RVUs when the E/M code itself is used as the
primary way to report the work of the professional. In other words,
while many medical professionals rely on procedural codes with work
RVUs that account--appropriately--for their particular expertise and
the intensity associated with their overall costs in furnishing care,
the expertise of those who rely predominantly on E/M services to report
their services is left relatively underrecognized within the previous
and current E/M coding and valuation structure. This is because E/M
valuation is broad-based and the same E/M visit codes are routinely
reported both alone and with many different procedural codes. We
believe that this specific gap in appropriate valuation and coding is
in addition to, and not overlapping with, the gaps in coding and
valuation that led to the creation of care management coding, remote
patient monitoring, etc. As we understand them, these latter codes
describe services furnished and resource costs incurred in addition to
the intensity and professional work within the visits themselves.
Consequently, we do not believe the inherent complexity code would be
duplicative of care management services since the inherent complexity
better recognizes the professional work within the visit, while the
care management codes recognize services that happen outside of the
visit. This applies, of course, when the inherent complexity code is
appropriately reported as a way to characterize E/M visits associated
with medical care services that serve as the continuing focal point for
all needed health care services and/or with medical care services that
are part of ongoing care related to a patient's single, serious
condition or a complex condition.
We recognize that many commenters, especially those concerned with
budget neutrality-based payment reductions should the proposal be
finalized and implemented, disagree with our assertion that there is
historical (and ongoing) underrecognition in coding and valuation of
resources involved in primary and nonprocedural care are an inherent
part of the coding and valuation system. Instead, we understand that
they view the current disparities in overall payment amount as
appropriately reflective of different resource costs in professional
work between procedural care and primary and non-procedural care.
In contrast, MedPAC acknowledges the disparity as a significant
problem but recommends the issue should be addressed outside of the
assignment of RVUs and code definitions for primary care. We appreciate
the commenters' perspectives and recognize that other payment
mechanisms could be utilized (perhaps even less controversially) to
address these problems, especially through the kinds of changes MedPAC
has recommended to Congress. However, we believe that we have the
obligation to value services as accurately as possible within the
structure of the resource-based relative value system, and that until
changes to coding and valuation are made to specifically address the
underrecognition of the complexity inherent to these kinds of visits
(either through this rule or another mechanism), the RVUs on the PFS
would otherwise perpetuate the systemic undervaluation of primary and
longitudinal, non-procedural care.
Comment: Other commenters supported the proposal and agreed that
the O/O E/M visit complexity add-on code better accounts for the
additional time, intensity, and practice expense inherent to
longitudinal care. These commenters offered that the PCM codes account
for care management and coordination over time as opposed to the
additional complexity and resources
[[Page 78973]]
involved in furnishing an office/outpatient E/M visit. They added that
primary care physicians may provide care management and coordination
services for a condition first addressed in an office/outpatient E/M
visit that will not last as long as three months or would not
reasonably be expected to result in a risk of hospitalization. These
commenters highlighted COVID-19 cases, for instance, as 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. They further
stated that alternatively, physicians, qualified health practitioners,
or their staff may provide care coordination and management services
for a condition that does meet these conditions, and the time may not
reach the required 30-minute interval. Thus, care coordination for a
month that includes 20 minutes of consulting with other physicians and
modifying medications to address an acute exacerbation of hypertension
would not meet the requirements for billing PCM. Despite the inability
to bill for these services, ongoing coordination and medication
management is a standard part of comprehensive primary care. The
commenters stated that the distinctions and limitations of TCM, CCM,
and CCCM are similar with specific time thresholds. With respect to
prolonged services codes, these commenters noted that primary care
physicians often provide complex office visits without requiring
additional time given that their training enables them to address a
significant number of diagnoses, risk factors, and symptoms in a short
time. Commenters added further that when prolonged services codes are
billed, they are not valued to include the additional intensity
inherent to primary care.
The commenters stated that the complexity inherent in primary care
includes evaluating how each condition and resulting treatment, new
symptom or challenge, unmet social needs, and recommended preventive
services interact and impact a person's overall wellbeing. The visits
involve balancing clinical guidelines and recommendations from a
multitude of sources including the United States Preventive Services
Task Force, the AAFP, the American College of Physicians or the
American Academy of Pediatrics (depending on the patient's age), the
American Psychiatric Association, the American College of Obstetricians
and Gynecologists (when relevant), the Advisory Committee on
Immunization Practices, and other evidence such as that published by
the CDC. They added that the primary care visit also involves
evaluating biochemical processes and drug interactions across several
medications, noting the extensive time counseling patients about new
and upcoming vaccines, like those for COVID-19 or respiratory syncytial
virus. The visit further involves the evaluation of lab and imaging
results sent by various care team members, reports from home health
aides or nurses, and immunization registries. They added that primary
care physicians and practitioners evaluate the persons' understanding
of their diseases and treatments and discuss behaviors or habits that
could impact their well-being. In the same encounter, primary care
practitioners provide several preventive screenings, including for
cancer, behavioral health, and substance use disorders. They provide
counseling and brief referrals based on the results of those
screenings, including help connecting patients to facilities providing
mammograms, colonoscopies, or behavioral health diagnoses. The
commenters asserted that most Medicare beneficiaries struggle to afford
their health care services and medications, so many primary care
physicians spend time on pharmacy discount websites alongside their
patients to help them get lower prices on their medications. The
commenters also stated that most orders for new screening or diagnostic
tests will require prior authorization for patients with primary or
secondary insurance through a plan administered by a health insurance
company. All of these findings and processes require documentation in
the medical record and updates to other health team members, such as an
endocrinologist, cardiologist, or psychiatrist. Commenters offered
clinical examples from primary care physicians.
Response: We appreciate the support from these commenters. After
consideration of public comments, we are finalizing changing the status
of HCPCS code G2211 to make it separately payable by assigning it an
``active'' status indicator, effective January 1, 2024, as proposed. In
addition, in consideration of the many comments we received, we
recognize that we should clarify when this code can be used.
Specifically, this add-on code is intended to characterize the base
service (that is, O/O E/M visits) based on the kind of care being
furnished (medical care services that serve as the continuing focal
point for all needed health care services and/or with medical care
services that are part of ongoing care related to a patient's single,
serious, or complex condition) to better account for the inherent
complexity of these visits that would otherwise be unaccounted for. 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. We agree with commenters who have pointed out that O/O E/
M visit levels, care management codes, and prolonged service codes are
intended to account for additional minutes of time or complexities for
individual patients. This code should be used when furnishing O/O E/M
visit 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.
We clarify that it is the relationship between the patient and the
practitioner that is the determining factor of when the add-on code
should be billed. First, 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. For example, a
patient has a primary care practitioner that is the continuing focal
point for all health care services, and the patient sees this
practitioner to be evaluated for sinus congestion. The inherent
complexity that this code (G2211) captures is not in the clinical
condition itself--sinus congestion--but rather the cognitive load of
the continued responsibility of being the focal point for all needed
services for this patient. There is previously unrecognized but
important cognitive effort of utilizing the longitudinal relationship
itself in the diagnosis and treatment plan and weighing the factors
that affect a longitudinal doctor patient relationship. In this
example, the primary care practitioner could recommend conservative
treatment or prescription of antibiotics. If the practitioner
recommends conservative treatment and no new prescriptions, some
patients may think that the doctor is not taking the patient's concerns
seriously and it could erode the trust placed in that practitioner. In
turn, an eroded primary care practitioner/patient relationship may make
it less likely that the patient would follow that
[[Page 78974]]
practitioner's advice on a needed vaccination at the next visit. The
primary care practitioner must decide--what course of action and choice
of words in the visit itself, would lead to the best health outcome in
this single visit, while simultaneously building up an effective,
trusting longitudinal relationship with this patient for all of their
primary health care needs. Weighing these various factors, even for a
seemingly simple condition like sinus congestion, makes the entire
interaction inherently complex, and it is this complexity in the
relationship between the doctor and patient that this code captures.
The second part of the add-on code also describes a relationship
between the practitioner and patient, but for specific types of
conditions. The add-on code describes ``medical care services that are
part of ongoing care related to a patient's single, serious condition
or a complex condition.'' Again, the ``ongoing care'' describes a
longitudinal relationship between the practitioner and the patient. In
comparison to the previous example, though, this is specifically in
reference to a single, serious condition or a complex condition. For
example, a patient with HIV has an office visit with their infectious
disease physician, who is part of ongoing care. The patient with HIV
admits to the infectious disease physician that there have been several
missed doses of HIV medication in the last month. The infectious
disease physician has to weigh their response during the visit--the
intonation in their voice, the choice of words--to not only communicate
clearly that it is important to not miss doses of HIV medication, but
also to create a sense of safety for the patient in sharing information
like this in the future. If the interaction goes poorly, it could erode
the sense of trust built up over time, and the patient may be less
likely to share their medication adherence shortcomings in the future.
If the patient isn't forthright about their medication adherence, it
may lead to the infectious disease physician switching HIV medicines to
another with greater side effects, even when there was no issue with
the original medication. It is because the infectious disease physician
is part of ongoing care, and has to weigh these types of factors, that
the E/M visit becomes inherently more complex and the practitioner
bills this code (G2211). Even though the infectious disease doctor may
not be the focal point for all services, such as in the previous
example, HIV is a single, serious condition, and/or a complex
condition, and so as long as the relationship between the infectious
disease physician and patient is ongoing, this E/M visit could be
billed with the add-on.
We appreciate the clarifying questions raised by commenters on the
appropriate usage of this add-on code. We will continue to engage with
interested parties on the use of this code and will consider developing
additional educational materials as needed.
Comment: Another commenter who supported our proposal offered
clinical scenarios they thought were excellent examples of the
complexity of care this code was intended to address:
Example A: A patient with sickle cell disease (SCD) visits the
clinic to see her hematologist and has clearly deteriorated
cognitively. The physician needs to understand if this is dementia or
SCD-related. Most of the time during the patient's visit is spent
ordering neurocognitive testing fand consulting with psychiatry.
Example B: A patient with SCD needs to be prescribed oxycontin for
their chronic pain. The provider also spends time during the patient's
visit managing other medications and then seeking the appropriate pre-
approval and prior authorization for oxycontin.
Response: We thank the commenter for providing these clinical
scenarios. However, the most important information used to determine
whether or not the add-on code could be billed is missing: the
relationship between the practitioner and the patient. If the
practitioner is the focal point for all needed services, such as a
primary care practitioner, this add-on code could be billed in these
examples. Or, if the practitioner is part of ongoing care for sickle
cell disease (a single, serious and complex condition) then the add-on
code could be billed. Otherwise, this add-on code could not be billed.
Again, this add-on code captures the inherent complexity of the visit
that is derived from the longitudinal nature of the practitioner and
patient relationship.
We also note unequivocally that this code is not restricted to
medical professionals based on particular specialties. Instead, it
should be used by medical professionals, regardless of specialty, with
O/O E/M visits (other than those reported with the -25 modifier) for
care that serves 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. We reiterate that when physicians and other
practitioners provide care that serves as the continuing focal point
for all needed healthcare services, they should report the inherent
complexity add-on code along with all reasonable and necessary O/O E/M
visits (not reported with the -25 modifier).
Comment: We received many comments on our proposal to not make
payment for HCPCS G2211 when the underlying O/O E/M visit had been
reported with modifier -25. Many commenters were supportive. Some
commenters opposed our proposal excluding payment when there were
underlying visits with modifier -25 because they believed some
preventive services would be rescheduled to a later date. One of these
commenters suggested that a more appropriate mechanism for addressing
any distinction between a stand-alone O/O E/M service and one at which
a physician elects to also perform a minor procedure is the National
Correct Coding Initiative (NCCI) edits that could be revised to bundle
code G2211 to codes for minor surgical procedures that are commonly
performed in the primary care or other non-procedural specialty care
setting. She further suggested a better option could be the creation of
HCPCS codes that are not add-on codes but rather adequately valued
codes representing visits for longitudinal care for all of a patient's
health care needs and/or ongoing care related to a patient's single,
serious, or complex condition which she believed might represent a
significant reduction in the burden of the add-on code assignment,
audit/overpayment risk, and stress until in her view a better health
care system design can be established for delivering and funding these
services.
Several commenters echoing the concern for preventive services
requested that the annual wellness visit be excepted from the policy.
Another commenter stated that modifier -25 is often used in cases where
clinicians are treating complex patients since these patients are
likely to receive multiple services on the same day. They stated that
excluding these cases therefore may be counter to the ultimate goal of
appropriately valuing complex O/O E/M services.
Another commenter wrote that patients often travel long distances
to receive care at their facilities requiring multiple visits with
different specialists for a variety of medical management and
interventions on the same day to treat a variety of disease co-
morbidities related to their cancer care. They stated it would be
appropriate for their primary treating physician to bill the G2211 add-
on code for the on-going coordination effort related to these complex
treatment plans regardless of the multiple visits occurring on the
[[Page 78975]]
same day. Another commenter stated that urologists frequently manage
multiple chronic conditions simultaneously and that certain diagnostic
procedures are commonly performed as part of the ongoing management of
a patient with chronic genitourinary disease. They recommended that CMS
consider permitting the use of modifier -25 in those situations where
the surgical code is associated with a 0-day global period and where
the sites of service are any of the O/O settings. They also suggested
that specific CPT codes 52000 and 51741 be exempt from our policy to
not pay the inherent complexity add-on when modifier -25 is reported on
the base O/O E/M code so that urologists could continue to perform
these tests and be appropriately paid for providing longitudinal care
for the multiple chronic conditions the manage simultaneously.
Response: We thank commenters for raising these concerns and
offering suggestions on how we might refine the policy. First, we are
clarifying that modifier -25 is reported in instances where the
physician or practitioner billing the O/O E/M is the same one who is
billing the significant separately identifiable procedure or other
service on the same day. Commenters seemed to incorrectly suggest
modifier -25 was reported with an O/O E/M visit if the patient had a
visit or procedure with another physician or another practitioner on
the same day as the physician or practitioner billing the O/O E/M
visit. With respect to the concern that a physician or practitioner
would not perform a preventive service on the same day as an O/O E/M
visit merely to avoid our policy to not pay G2211 when the O/O E/M
visit is reported with modifier -25, we intend to monitor the
utilization of this code and continue engagement with interested
parties as this policy is implemented. With respect to the suggestion
for a new set of parallel codes for the kind of care captured by
inherent complexity add-on code we believe such a set of codes could
increase administrative burden with minimal benefit gained and
unnecessarily delay reactivation of the complexity add-on code and
payment. Similarly, we believe relying on NCCI edits to single out
unbundled procedures or services with which G2211 should not be billed
would also increase administrative burden and delay reactivation.
Finally, for future rulemaking and as discussed in the next section, we
remain open to considering additional iterations in coding and
valuation within the PFS that would meet the same goals regarding the
appropriate valuation of these services.
Comment: Many commenters expressed concerns or disagreed with our
utilization estimates for G2211. Many commenters were appreciative that
we have revised our utilization estimates resulting in a smaller
negative impact on the budget neutrality conversion factor. However,
most commenters urged to further refine these assumptions to prevent
reductions in the conversion factor that they noted might, in fact, not
be warranted by actual usage. They suggested that there continues to be
a lack of clarity surrounding the appropriate circumstances for
reporting the inherent complexity add-on code and that combined with
potential implications for patient cost-sharing, health care
practitioners would experience ambiguity toward billing the code, which
could result in our having overestimated utilization. Many other
commenters asked that we align utilization estimates with the actual
first year utilization of care management codes for transitional care
management (TCM) and chronic care management (CCM). Some commenters
asked us to make mid-year adjustments to the conversion factor if in
our monitoring we find that we overestimated utilization of the code.
Response: We have considered the suggested factors but do not
believe those care management codes are an apt comparison for G2211
utilization, given several limitations in their code descriptors and
other requirements which are not applicable to the inherent complexity
add-on code. We also believe that the documentation requirements
specific to the care management codes may have contributed to the
slower uptake in utilization than was estimated for the first year.
Additionally, we believe the additional clarifications we are making in
this final rule about when it is appropriate to bill the inherent
complexity add on code will give practitioners increased confidence to
bill the inherent complexity add-on code appropriately. Finally, we
note that we make budget neutrality calculations on a prospective
annual basis and would not be able to make mid-year retrospective
adjustments to the conversion factor as was suggested by some
commenters. CMS uses claims data for the services as they become
available in subsequent years, to inform budget neutrality adjustments
that would apply for a given year.
c. Request for Comment About Evaluating E/M Services More Regularly and
Comprehensively
Over the last several years, we have received suggestions/
recommendations outside of the rulemaking process that CMS consider
using a different approach for valuing services that rely on research
and data other than the AMA RUC's specialty-specific valuation
recommendations. These commenters have highlighted that the evolving
practice of medicine looks significantly different than it did when the
resource-based relative value scale (RBRVS) was established three
decades ago. Disease prevention and health promotion have grown in
practice, and patient expectations are higher for managing
hypertension, diabetes, and hypercholesterolemia. Additionally, more
pharmaceuticals and new biologics have expanded therapeutic options for
non-procedural care. Commenters have suggested convening expert panels
that might review pertinent research and recommend resource
recalibrations to update relative values under the PFS. The commenters
suggested that such independent assessments could support CMS and the
broader health delivery and health finance community in addressing
growing distortions in resource allocations under the PFS for certain
types of services, including evaluation and management visits and other
non-procedural/non-surgical services.
For many years, CMS has worked to address coding and payment
deficiencies, explicitly focusing on instances where resources are not
well accounted for in the inputs for certain services, including where
significant differences in relative resources involved in furnishing
care are not reflected in the coding distinctions, or where too-
specific coding makes valuation at appropriate intervals impractical.
As we continue ongoing work to establish resource-based relative units
for PFS services, we have sought and still seek public comment about
the potential range of approaches CMS could take to improve the
accuracy of valuing services. We continue to be interested in how we
might improve the accuracy of valuation for services, and sought
information about how we might evaluate E/M services with greater
specificity, more regularly and comprehensively in the proposed rule.
As we consider how CMS can potentially move forward with reforms to
the way we establish values for E/M and other services, we specifically
sought comment in the proposed rule
[[Page 78976]]
from the public on the following questions:
a. Do the existing E/M HCPCS codes accurately define the full range
of E/M services with appropriate gradations for intensity of services?
b. Are the methods used by the RUC and CMS appropriate to
accurately value E/M and other HCPCS codes?
c. Are the current Non-E/M HCPCS codes accurately defined?
d. Are the methods used by the RUC and CMS appropriate to
accurately value the non-E/M codes?
e. What are the consequences if services described by HCPCS codes
are not accurately defined?
f. What are the consequences if services described by HCPCS codes
are not accurately valued?
g. Should CMS consider valuation changes to other codes similar to
the approach in section II.J.5. of this rule?
In the proposed rule, we stated that we are particularly interested
in ways CMS could improve processes and methodologies. We requested
that commenters provide specific recommendations on improving data
collection and making better evidence-based and more accurate payments
for E/M and other services. We expressed particular interest in ways
that we can make more timely improvements to our methodologies to
reflect changes in the Medicare population, treatment guidelines, and
new technologies that represent standards of care. We also asked for
recommendations to ensure that data collection from and documentation
requirements for physician practices are as least burdensome as
possible while maintaining strong program integrity requirements.
Finally, we also expressed interest in whether commenters believe that
the current AMA RUC is the entity that is best positioned to provide
recommendations to CMS on resource inputs for work and PE valuations,
as well as how to establish values for E/M and other physicians'
services; or if another independent entity would better serve CMS and
interested parties in providing these recommendations.
We received public comments on some or all of these questions from
more than 50 commenters. The following is a summary of the comments we
received and our responses.
Comment: In response to a., ``Do the existing E/M HCPCS codes
accurately define the full range of E/M services with appropriate
gradations for intensity of services?'' some commenters responded that
recent revisions of the E/M services were extensive and specifically
addressed the granularity of services by allowing for gradation in
reporting through allowing use of medical decision making or time on
the date of the encounter (straightforward, low, moderate, and high),
further enhanced by the development of coding for prolonged services.
They believe the prolonged services codes, non-face-to-face services
codes, clinical staff services codes, screening codes, care management
codes, and HCPCS Category II codes reported for the evaluation and
management of a patient allow for reporting of many nuanced
interactions with a patient both on the day of encounter and between
encounters. They expressed concern that HCPCS codes that CMS has added
have created an unbundled component coding system with significant
overlap of codes billable for the evaluation and management of Medicare
beneficiaries and believe that while E/M and care management services
have a sufficient gradation of intensity of work, they do not
comprehensively define typical work, resulting in duplicative payment
that CMS has not audited.
Other commenters believed that the acuity between higher-level E/M
codes is often quite steep and inconsistent with the differential
between lower-level codes. They believed that rapid implementation of
G2211 is necessary in accounting for this higher acuity and complexity.
Similarly, another commenter stated that O/O E/M encounters represent a
broad and diverse range of diagnoses and that the full set of E/M codes
is relatively small, given the wide variety of encounters they are
meant to describe. They added that CPT is better at describing discrete
procedures than E/M services, especially E/M services that represent
continuous, comprehensive primary care. Another commenter stated that
the RUC tends to value codes primarily based on the physical skill
involved and that cognitive services (that is, critical thinking
involved in data gathering and analysis, planning, management, decision
making, and exercising judgment in ambiguous or uncertain situations)
are routinely undervalued. Another commenter suggested that many
primary care activities are not accounted for under fee-for-service
(FFS) payment. They stated that over the past decade, CMS has expanded
the range of E/M services separately billable under the PFS but are
concerned this piecemeal, code-by-code approach within the PFS may
never fully account for the resources used to furnish primary care.
They do not see the PFS as it is currently configured to be a platform
allowing Medicare to pay for a broad range of elements defining primary
care. Another commenter stated that the current high-level O/O E/M
service codes do not distinguish between managing a few concurrent
conditions, many concurrent conditions, and a single highly intense
condition effectively. They further asserted that the original
gradations within the outpatient and inpatient E/M service code
families were not based on clinical evidence but rather Medicare
payment data, which was likely distorted, and there has been no attempt
to address these gradations. Another commenter stated they did not
believe that the current outpatient and other E/M service codes reflect
the work and resources required to deliver non-procedural and
cognitively intense care to Medicare beneficiaries. They stated that
the most recent revisions of E/M service code definitions and
valuations have not remedied the original problems and failed to
capture the intensity of E/M care, particularly the care provided to
Medicare beneficiaries with one or more complex comorbid conditions.
Response: We appreciate commenters' assertion that the current E/M
coding structure does not adequately capture certain types of primary
care. Our established policy for the complexity add-on code, as
finalized in the CY 2019 PFS final rule and proposed with modifications
for CY 2024, is rooted in our long-standing assessment that there are
certain complexities inherent in furnishing some kinds of E/M visits
that the current E/M coding and visit levels do not fully recognize,
similar to what the commenters have highlighted. We continue to believe
about how best to address this issue within the framework of the PFS
and welcome ongoing dialogue with all interested parties.
Comment: In response to b. ``Are the methods used by the RUC and
CMS appropriate to accurately value E/M and other HCPCS codes?'' many
commenters responded that they believed the methods used by the RUC and
CMS are appropriate to value E/M and other HCPCS codes. They stated
that standard packages for pre-service time, post-service time,
practice expense direct input benchmarks, and pre-service clinical
staff time packages were implemented, allowing for enhanced relativity
and comparison among all services. They relayed that the median number
of RUC survey respondents in recent years is 70, with surveys for high-
volume services having more than 100 physician respondents. They added
that the recent office visit RUC survey yielded the highest number of
responses in the history of the RUC process, with 1,700 physicians
completing the survey.
[[Page 78977]]
They stated that the survey was the concerted effort of 51 specialty
societies and other healthcare professional organizations that
represented 95 percent of Medicare claims for E/M office visits. They
further added that the RUC incorporates extant data when possible, such
as data from the Society of Thoracic Surgeons, American College of
Cardiology, and National Surgical Quality Improvement Program (NSQIP).
These commenters requested that CMS make one methodological improvement
to restore the Refinement Panel process, serving as an appeal process
for those commenting on CMS's proposed relative values. Another
commenter expressed concern that unlike the RUC's process, which they
stated is based on statistics, CMS's methods to assign values to E/M
and other HCPCS codes, especially G-codes, are opaque and not
scientifically sound. They stated in doing so, CMS undermines the
relative nature of the PFS. Another commenter explained that to
identify potentially misvalued services, the RUC identifies, maintains,
and reviews a list of new services and services that use new
technology, develops objective screens based on defined criteria, and
examines all services in which utilization estimates are more than
expected.
In their comment letter to the proposed rule, MedPAC highlighted
their long-standing problems with the data and processes used to set
different services' RVUs, which they concluded have led to certain
services (for example, procedures, imaging, and tests) becoming
overvalued relative to other services (for example, E/M services). They
believe CMS relies heavily on RUC recommendations when setting RVUs,
even though most of the RUC's members have a financial stake in setting
payment rates, about which researchers have expressed RUC transparency
and objectivity concerns. MedPAC further stated that as far back as
2006, they recommended that CMS augment the RUC with a standing panel
of experts that could help the agency identify overvalued services and
review recommendations from the RUC. They also recited some of their
other past recommendations. They added that, in their view, a wide
range of codes should be reviewed using new data and analyses,
beginning with the 10- and 90-day global surgical codes. They noted
that because of the evidence of the substantial overvaluation of 10-
and 90-day surgical global codes, they have continued to support CMS's
prior proposal to convert all 10- and 90-day global surgical codes to
lower-priced 0-day global codes and allow practitioners to separately
bill for postoperative visits on a FFS basis (that is, outside of the
global package). Some commenters shared this view about global surgical
codes, whereas others took an opposite view in response to the
questions below.
Other commenters stated that the methods used by the RUC and CMS do
not lead to accurate valuation and that the problems lie with the
nature of E/M services and the PFS's budget neutrality adjustment. They
stated that the resources used in furnishing the work portion of E/M
services are primarily a function of the time the clinician spends with
the patient and, therefore, are not amenable to efficiency gains and
that the valuation process is not responsive to efficiency gains,
leading to passive devaluation of E/M services under the constraints of
budget neutrality. They recommend a robust process, supported by an
expert advisory panel, to review misvalued services, which would focus
on replacing magnitude estimation with a building block approach to
valuation. Other commenters stated that they believed there were
several methodologic issues in the RBRVS initial work done by Bill
Hsiao and Peter Braun, some of which were identified by the original
investigators, undermining its ongoing value. They stated that
clinically significant factors, such as the expertise needed to manage
specific complex clinical conditions or multiple simultaneous clinical
conditions, are not currently recognized. They stated low response
rates and small sample sizes for the RUC surveys distinguished this
feature from the original methodology employed by Hsiao et al., whose
validity depended critically on robust sample sizes. These commenters
suggested additional data sources could result in more robust
recommendations and recommend that CMS invest resources in other
supplemental sources of information, especially physician time, rather
than relying almost exclusively on the RUC. Another commenter stated
that the current survey methodology has several limitations that impact
both E/M and non-E/M services, including low response rates, an
inability to determine if the responses received are accurate
reflections of real-world clinical practice and substantial variations
in modern-day clinical practice for the same HCPCS code across
different specialties. They added that more direct methodologies might
be more costly and burdensome. Still, they would reflect the actual
time and effort inherent to a particular HCPCS code more accurately.
They believe that time and motion studies could be used to determine
the required resources for RBRVS. Another commenter stated that it is
more difficult to quantify the physician work involved in E/M services
than for more specific procedural service vignettes in the RUC survey
process, given that the survey focuses on the ``typical'' patient and
distributes surveys based on vignettes for E/M services that are much
less specific. They added that the input of the primary care
specialties that provide the most complex E/M services and do so most
commonly is undervalued when these broad E/M vignettes are surveyed
across more than 50 specialty societies, many of which do relatively
few and much more straight-forward E/M visits than primary care.
Another commenter stated that fundamental problems with the
outpatient and other E/M codes would not be solved by the existing
processes employed by the Current Procedural Terminology (CPT)[supreg]
Editorial Panel and the American Medical Association (AMA) RUC. They
stated there is an expertise bias on the RUC toward procedural care
based on the panel's composition influencing how services are valued.
They posited that a significant portion of the value of E/M and other
non-procedural services lies in the physicians' skills and expertise in
diagnosing and managing complex conditions, coordinating care,
considering the patient's overall health and well-being, and making
treatment decisions that consider various factors beyond just the face-
to-face interaction between the physician and patient, which is harder
to quantify in a survey.
Response: We appreciate the perspectives shared by commenters and
recognize that there are opportunities to improve how all services are
valued and better account for resource variation for different types of
care under the PFS. Our policy for the complexity add-on code reflects
several years of consideration and engagement with interested parties
to address these long-standing issues. However, we view our
implementation of the inherent complexity add-on code as an improvement
in valuation and coding compared to the status quo, not necessarily an
end in itself. We welcome engagement on this broader issue of
recognizing costs for specific services as we have described, including
through our usual review of coding and recommendations for PFS services
from the AMA editorial panel, RUC, and other interested parties.
Comment: In response to c., ``Are the current Non-E/M HCPCS codes
accurately defined?'' some commenters responded, yes, the current non-
E/M
[[Page 78978]]
HCPCS codes are accurately defined through the CPT Editorial Process
and called the process a respected method that is best suited to
preserve accurately defined medical codes. They added that not only are
HCPCS level I CPT codes generated and accurately defined, but the
reporting guidelines and instructional parentheticals are also
established to ensure proper usage and reporting of such codes. These
commenters stated that, in contrast, descriptors for HCPCS level II
codes developed by CMS through an application process twice per year or
as C-codes and G-codes are often ill-defined because CMS does not
differentiate them from existing HCPCS level I CPT codes, resulting in
reporting confusion. Other commenters stated that the PFS has
experienced a proliferation of non-E/M codes whose fine-tuning of time
and intensity to distinguish minor variations in resource costs creates
a false sense of accuracy because empirical times are subject to
unavoidable measurement error and intensity estimations should be
limited to a few clearly-defined intervals.
Response: We thank the commenters for their feedback. We recognize
the role that certain interested parties play in establishing the HCPCS
level I coding that healthcare practitioners use to bill for the
services they furnish and note that we routinely rely on the CPT coding
process as a critical part of our process for recognizing and paying
for such services under the PFS. We also acknowledge that in some
circumstances, when we must act to address beneficiary access or
practitioner payment issues, we can establish HCPCS level II coding,
and we do so in the public interest, reflecting our consideration of
appropriate coding and provider administrative burden. We also
recognize that there are intrinsic limitations in the level of
specificity in time and intensity as reflected in the RBRVS, regardless
of the origin of the service definition in coding or how many survey
responses are considered in the valuation process.
Comment: In response to d., ``Are the methods used by the RUC and
CMS appropriate to accurately value the non-E/M codes?'' commenters
stated that it is important that all services be examined via the same
resource-based relative value scale methodology to ensure fairness,
consistency, and relativity. Another commenter stated that CMS has
often discounted intensity and over-relied on time as a measure of
value. They characterized intensity as based on requisite education and
training, dealing with complex patient cases that are physically
challenging during treatment with a risk of unexpected intraoperative
complications. They stated that managing these patients requires
considerable mental effort and judgment, with the procedure's outcome
more dependent on the surgeon's skill than the time necessary to
accomplish it. Other commenters believed that the process used by CMS
is typically a calculation made by a nonphysician practitioner (NPP)
using math without physician validation. They stated that a glaring
example of CMS inaccurately valuing non-E/M codes is the failure to
incorporate the RUC-recommended work and time incremental increases for
the revised office/outpatient visit E/M codes into global codes. They
noted that CMS did finalize adjustments for other bundled services,
such as maternity codes, in the CY 2021 PFS. They implored CMS to
follow precedent and correct this issue. They also believed that recent
decisions had been incorrectly made solely on time, without adequate
consideration of the intensity involved, and that time should not be
the deciding factor in code valuation. Some commenters stated that the
methods used by the RUC are appropriate to value E/M and non-E/M codes.
They believed the underlying RBRVS methodology remains relevant today
and that the RUC valuation process continues to improve with the
development of numerous standards/policies/conventions to improve
relativity and ensure consistency. They remarked that standard packages
for pre-service time, post-service time, practice expense direct input
benchmarks, and pre-service clinical staff time packages have been
implemented, allowing for enhanced relativity and comparison among all
services. Another commenter voiced frustration at what they
characterize as a lack of rationale provided for CMS' decisions when
they differ from RUC recommendations. They stated that it is difficult
to respond when CMS' rationale is only a ``belief'' that a crosswalk to
another code is better than the RUC recommendation or the data from the
survey. They added that, without additional substantive rationale, just
because a CPT code has the same intra-service or total time, does not
mean another code should share its exact physician work RVU. They and
other commenters urged CMS to consider restoring the Refinement Panel
process that served as an appeals process for those commenting on CMS
proposed relative values.
Other commenters stated that there is ample evidence that many non-
E/M services are overvalued due to time over-estimations and payment
for bundled post-operative visits that rarely occur. Additionally, they
stated that unlike under the original Harvard study methodology, on
which the RUC magnitude estimation process relies, RUC survey
respondents are likely aware that a higher rating of time and work
directly leads to a higher work RVU for the rated procedure. They added
that this problem is illustrated in the CMS proposed rule section on
the valuation of specific codes where estimates and work RVUs,
originating with whom they termed self-interested participants in the
process, are evaluated at the statistical median, whereas others, out
of a concern about inadequate data, are evaluated at the 25th
percentile. They stated that choosing statistics this way does not
overcome the problem of inadequate data and invites conflicts of
interest. Furthermore, they stated that many survey respondents have
not performed the service in question, as there is no requirement for
it, calling into question the validity of their assessments. They
recommended: (1) Moving the estimation of work from subjective
magnitude estimation to analysis relying primarily on a measured-time-
data-informed building block approach; (2) Routinely and periodically
observing and collecting measured, actual-time data for work (and
direct PE) from a rotating panel of practices and other healthcare
providers; and (3) Adoption of a criterion for the misvalued codes
initiative to identify codes within BETOS families that have aberrant
intensity values, what the RUC has termed ``rank order anomalies.''
They recommended that accurate data collection, particularly for code-
specific time data from practices, should be central to this review.
Another commenter, taking a similar approach, suggested that CMS
develop an agency-based independent process parallel to the RUC for
service valuation. They envisioned this parallel process would take a
fundamentally different approach to valuation that would use empirical
data and the building block approach to value services. CMS might use
the RUC estimates to determine valuation in selected situations. They
posited that a CMS process would not be bound by the inherent
distortions in representation between cognitively intense and
procedural specialties currently found in the RUC.
Response: We thank the commenters for their feedback on this
specific question. We share the same concerns about effectively valuing
and accounting
[[Page 78979]]
for resources involved in furnishing in the services paid under the
PFS, especially when considering codes of dissimilar structures. We
recognize that there are varying perspectives on how to best reflect
the inputs for services paid under the PFS, which is why we are
engaging in this dialogue and asking these questions. As part of our
obligation to maintain the PFS and ensure access to services for
Medicare beneficiaries, 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. In response to the comments expressing concern
about our valuation review process, we note that our approach does
consider the expertise supporting the RUC process. We primarily use the
RUC-recommended values as a starting reference for services under
review and then apply one of these several methodologies, which we have
discussed in detail in past rules to account for adjustments to
specific inputs that we believe were not otherwise reflected in the
RUC-recommended value. We note our current process of proposing the
majority of code values in a proposed rule, allowing the public to
comment on those proposed values, and then finalizing those values in a
final rule offers greater transparency and accountability than the
refinement panels which we established to assist us in reviewing the
public comments on CPT codes with interim final work RVUs. Our process
also offers greater transparency and accountability than the refinement
panels in balancing the interests of the specialty societies who
commented on the work RVUs with the budgetary and redistributive
effects that could occur if we accepted extensive increases in work
RVUs across a broad range of services. Further, we have established an
annual process for the public nomination of potentially misvalued
codes, which allows those who believe that values for individual
services are inaccurate and should be readdressed through notice and
comment rulemaking, including possibly through the RUC process, to
bring those codes to our attention. We disagree with the comments
asserting that we discount intensity entirely and rely on time alone as
a measure of value for certain services, though we acknowledge
commenters for particular codes have sometimes urged us to give more
weight to assertions regarding greater relative intensity, much like
some interested parties have urged us to consider intensity as
reflected in survey data overall. Following our statutory authority, we
have consistently considered revisions to valuations based on the
relative resources involved in furnishing the service, which include
time and intensity. We have always stated in past discussions on this
issue that we believe that changes in time and intensity must be
accounted for when developing work RVUs. Thus, 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. 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 2024 PFS final rule, CPT codes 76987, 97550, and 99497 all
share the same total work time of 40 minutes. However, these codes had
very different proposed work RVUs of 1.62, 1.00 and 1.50, respectively.
These examples demonstrate that we do not value services purely based
on work time; instead, we incorporate time as one of multiple factors
in our review process, and we anticipate continuing to engage in
constructive dialogue with the community regarding the appropriate
weighing of time and intensity in establishing work RVUs.
Comment: In response to e., ``What are the consequences if services
described by HCPCS codes are not accurately defined?'' some commenters
stated that the RUC's Relativity Assessment Workgroup (RAW) process
helps to identify a lack of clarity or the need for change in
descriptions due to changing technology. They believed that CMS's
differing coding methodologies for reporting prolonged services deepen
the administrative burden for healthcare professionals and increase the
potential for improper coding. Many commenters expressed that it is
imperative that physicians have one set of clear codes and guidelines
to report medical procedures and services and that if other HCPCS level
II codes are created that are not accurately defined, it could lead to
improper reporting of medical services to Medicare and other insurers.
Another commenter stated that inappropriate utilization, particularly
if no health benefit is obtained for the patient or population, can
lead to high healthcare costs. Another commenter stated that when HCPCS
codes are poorly defined, clinicians and other healthcare professionals
may be challenged with when and how to confidently adopt HCPCS codes in
their clinical practice, which can lead clinicians, other healthcare
professionals, and their administrative staff to inadvertently misuse
or misapply a HCPCS code, leaving them vulnerable to program integrity
audits.
Response: We recognize the role that certain interested parties
play in establishing HCPCS level I coding that healthcare practitioners
use to bill for the services they furnish and note that we routinely
rely on the CPT coding process as a critical part of our process for
recognizing and paying for services under the PFS. We also acknowledge
that in some circumstances, when we must act to address beneficiary
access or practitioner payment issues, we establish HCPCS level II
coding, and we do so in the public interest, reflecting our
consideration of Medicare policy goals, appropriate coding, and
healthcare provider administrative burden.
Comment: In response to f., ``What are the consequences if services
described by HCPCS codes are not accurately valued?'' some commenters
stated that the intent of the RBRVS is to ensure that the payment of
one service is relative to the payment of another when accounting for
the resources consumed in the provision of the service. They
furthermore stated that if the relativity of one service is
undervalued, physicians may not be able to sustain the practice of
providing that service in an office setting. Likewise, a significant
overvaluation of a service may provide a financial incentive to perform
the service. They added that the RUC created the RAW to develop
objective and fair screens to identify potentially misvalued services
and address these issues. Another commenter stated that there may be
services described by multiple overlapping codes, likely resulting in
duplicative billing and overpayments for a single service. They urged
CMS to research and audit utilization of the over 150 CPT codes and
HCPCS G-codes for reporting unbundled, finite pieces of E/M services
for which they stated a potential for overpayment may result in fraud,
waste, and abuse under the Medicare program.
MedPAC commented that when subsets of services are overvalued, it
[[Page 78980]]
causes the gap between the compensation of different clinical
specialties to be more significant than it otherwise would be. They
reported that in 2021, the median compensation for surgical specialties
was $441,000, well above the $264,000 that primary care physicians
earned. They added that this large compensation gap makes careers as
primary care providers less financially attractive than careers as
specialists and may be a factor in why the supply of primary care
physicians in the U.S. has been declining in recent years. Other
commenters expressed similar views, citing MedPAC and a National
Academies of Science, Engineering, and Medicine (NASEM) 2021 consensus
report that concluded that the current approach to FFS valuation has
``resulted in systematically devaluing primary care services relative
to other services and its population health benefit . . .''
Response: We agree that there may be distortions in the PFS that
result from disparities in coding and valuation, which is at the core
of the issue we have highlighted and are working to address by
implementing the inherent complexity add-on code as discussed above.
Comment: In response to g., ``Should CMS consider valuation changes
to other codes similar to the approach in section II.J.5. of this
rule?'' some commenters stated that CMS should not consider valuation
changes like the approach in section II.J.5. of the CY 2024 PFS
proposed rule. They remarked that the calculation proposed for the
increase in behavioral health services is not resource-based and could
potentially distort the RBRVS. They added that section 6102 of the
Omnibus Budget Reconciliation Act of 1989 (Pub. L. 101-239) that
created the RBRVS requires that the relative values are based on
resource costs. They stated that CMS should not use arbitrary
calculations to adjust specific services performed by one specialty to
tackle issues outside of the scope of the RBRVS payment system and that
access and shortage issues should be addressed through legislative
solutions and funded by Congress.
Response: We do not agree that recognizing distortions in valuation
and accounting for them within the RBRVS departs from basing valuation
on resources. Instead, we believe that deliberate failure to account
for systemic distortions in the methodologies, once recognized, would
violate resource-based valuation. We look forward to continued
engagement with interested parties so that more comprehensive and
consensus-based solutions to address these distortions within the
ratesetting methodologies can be implemented. We received public
comments in response to our requests, following the items a. through
g., for recommendations on a series of specific topics: improving data
collection and making better evidence-based and more accurate payments
for E/M and other services; making more timely improvements to our
methodologies to reflect changes in the Medicare population, treatment
guidelines, and new technologies that represent standards of care;
ensuring that data collection from and documentation requirements for
physician practices are as least burdensome as possible while
maintaining strong program integrity requirements; and finally whether
commenters believe that the current AMA RUC is the entity that is best
positioned to provide--recommendations to CMS on resource inputs for
work and PE valuations, as well as how to establish values for E/M and
other physicians' services, or if another independent entity would
better serve CMS and interested parties in providing these
recommendations.
Comment: In response to the interest we expressed in hearing
potential ways that we could improve processes and methodologies, and
our request that commenters provide specific recommendations on ways
that we can improve data collection and make better evidence-based and
more accurate payments for E/M and other services, some commenters
stated that the RUC is continuously improving its processes to ensure
it best utilizes reliable, extant data., as noted above, in response to
``b.'' Another commenter stated that while the RUC can recommend
relative work RVUs and direct PE details, because adjustments for
inflation have not been applied to such services via statute, CMS
cannot pay providers at the appropriate rate for the work and PE
measured. They stated that to make more accurate, evidence-based
payment for E/M and other services, Congress must adjust the factors
that impact reimbursement rates under the PFS, and they urged CMS to
support such Congressional efforts. They also encouraged CMS to
consider examining electronic health record (EHR) data as a credible
source for provider work, not only for global codes but also for
services provided by PCPs over a 30-to-90-day period to ensure there is
no overlap in work. They added that services reported over the 10-day
global period for E/M office visits should also be reviewed for
duplicative work and that because many services can be reported using
time, a time modifier could enhance the ability for EHR and other
program integrity audits to identify overlapping services provided in
person or via telehealth.
Another commenter recommended that CMS consider using a
supplemental independent panel of experts to provide recommendations on
evidence-based and accurate valuation of services under the PFS. They
stated that a more formalized process for submitting data to CMS
(including publicizing how, where, and by when to submit available
data) could also be helpful to stakeholders who are not as regularly
engaged with the staff who draft the PFS proposed and final rules to
share any data they do have access to.
We also received public comments in response to our particular
interest in recommendations on making more timely improvements to our
methodologies to reflect changes in the Medicare population, treatment
guidelines, and new technologies that represent standards of care.
Response: We appreciate the commenters' concerns and acknowledge
that there are changes in treatment standards and new technologies that
should be recognized better in the PFS. Moreover, we realize that
aspects of the PFS methodology need to be revised to better account for
these changes. Over the last several years, we have engaged in research
to identify viable approaches to updating the data inputs we use to
better set payment rates to reflect these changes. We thank the
commenters for their thoughts, as your engagement is crucial to our
ongoing efforts to understand critical variables in any attempt to
reform the PFS, including identifying alternate data sources (like
EHRs) to support the refinement of data inputs or, more broadly,
identifying how to proceed within our existing statutory authority or
when congressional may be required to facilitate necessary fundamental
changes to calculating physician payment rates.
Comment: Many commenters suggested that CMS may improve
methodologies by improving access to Medicare and Medicaid data. They
added that disseminating Medicare utilization data earlier would be
particularly helpful to immediately understand if the utilization of a
service is as anticipated. They suggested that the first quarter of
Medicare claims data should be available by July 1st of each year, and
a full year of claims data should be available by April each year (for
example, 2023 data should be publicly available by April 2024). They
[[Page 78981]]
requested that CMS share recent Medicaid data and investigate
mechanisms to collect and share Medicare Advantage encounter
information.
One commenter stated that the RUC identifies, maintains, and
reviews a list of new services and services that use new technology,
develops objective screens to identify potentially misvalued services,
and examines all services in which utilization estimates are more than
expected. They stated that since its inception in 2006, the RAW and CMS
have identified over 2,700 services through over 20 screening criteria
for further review by the RUC. Another commenter stated that due to a
lack of transparency, they do not know what methodologies CMS employs
to be able to provide recommendations on more timely improvements for
HCPCS G-codes. They stated that from their perspective, CMS often
reacted to stakeholder requests by creating G-codes--sometimes for
services that do not need to be urgently reportable--and often based
them on new technology that has not reached sufficient evidence for
support.
Response: We appreciate the commenters' concerns and acknowledge
that there are changes in treatment standards and new technologies that
could be recognized better within the PFS. We thank the commenters for
their thoughts, as their engagement is crucial to our ongoing efforts
to understand critical variables in any attempt to reform the PFS,
including identifying alternate data sources (like EHRs) to support the
refinement of data inputs or, more broadly, identifying how to proceed
within our existing statutory authority or when congressional action
may be required to facilitate necessary fundamental changes to
calculating physician payment rates.
We also received public comments in response to our interest in
recommending that data collection and documentation requirements for
physician practices are as least burdensome as possible while
maintaining strong program integrity requirements.
Comment: Some commenters supported addressing the significant
administrative burden plaguing physicians and other healthcare
professionals. They added that physicians and other healthcare
professionals have limited time and other resources to participate in
data collection efforts. Another commenter stated documentation should
be utilized for clinical purposes and should not burden physicians to
satisfy administrative or billing requirements. They noted that
supporting the national medical specialties and other health care
professional organizations is imperative in obtaining adequate data on
the resources required to provide services. Another commenter believed
that modifiers (for example, a modifier when an E/M service is reported
using time) would be very useful to assist with program integrity
audits. They thought CMS should collect data (for example, service
times, the number and types of services reported on any day by a given
provider) from EHR vendors to evaluate billing patterns better. They
believed that without this information from EHRs regarding times and
visits, in some scenarios, patients may not receive the care they
expect and deserve.
Response: We appreciate commenters' interests and will consider
them both for future rulemaking and as part of ongoing efforts to
improve transparency.
Finally, we also received public comments in response to our
interest in whether commenters believe that the current AMA RUC is the
entity that is best positioned to provide--recommendations to CMS on
resource inputs for work and PE valuations, as well as how to establish
values for E/M and other physicians' services; or if another
independent entity would better serve CMS and interested parties in
providing these recommendations.
Comment: Many commenters objected to the question and noted that
any individual or entity, including the RUC, has a constitutional right
to provide recommendations to CMS on resource inputs for work and
practice expense valuation. One commenter stated that it is when CMS
deviates from the RUC process, such as with creating the add-on code
and providing no evidence of its time or relative intensity, that the
entire RUC process' legitimacy becomes threatened, positing that if
medical societies perceived that CMS would ignore their good-faith
participation in a consensus-based process, there would be even more
efforts to seek legislative action, thereby resulting in an even more
inconsistent system. Several commenters stated that the RUC
recommendations to CMS are based on extensive granular data to describe
physician time, work relativity, and PE resources associated with
providing procedures and other services. They stated that CMS is not
required to accept RUC recommendations and that they will continue to
support and advocate for the RUC process in maintaining Medicare
relative values. Other commenters stated they played a significant role
in valuing new or revised services within their specialty, supported
the work of the AMA CPT[supreg] Editorial Panel to revise the entire E/
M code set, with those revised services then valued by the AMA RUC, and
believed that the processes used by the RUC provided an avenue for
physician input that helped to maintain an appropriate resource-based
payment system. They and other commenters noted that the RUC is best
suited for valuing physician services. Another commenter expanded upon
this view and noted that the AMA CPT Editorial Panel and the RUC are
the best-situated entities to provide input to CMS on values,
documentation, and coding as a part of the annual PFS rulemaking cycle,
including for E/M services. They stated the physician experts who
provided input at all stages of defining codes and valuing services as
part of the CPT and RUC continuum provided the essential clinical
knowledge needed to conduct these functions. They stated it also
involved members from across the medical community, not just the
specialty that delivers the service under review, to serve as a
sounding board and safety net in defining and valuing codes. This
commenter expressed concern that CMS attempted to marginalize the input
of CPT and RUC and another entity may serve as a mechanism to reverse-
engineer some other policy goal beyond providing medical expertise
about the resources and work that are provided when furnishing a well-
defined set of services. They and other commenters noted that CMS is
not bound by the recommendations of the RUC and posited that any
stakeholder is free to establish the infrastructure to generate
detailed, data-driven recommendations for the valuation of services.
They also noted that CMS continues to consider RUC recommendations
precisely because the RUC provides the best available information and
offers an unmatched coherent, data-driven rationale to its
recommendations. Another commenter stated that there is no need for
another independent entity to provide recommendations regarding the
valuation for services that are reported on the PFS. They noted the RUC
process for valuing services is fair and balanced, as experts across
all specialties engage in deeply informed discussions and must come to
a consensus (a two-thirds vote) to approve any recommendations. They
stated that having all major specialties at the table, within the
budget neutrality confines of the PFS, ensured that any changes are
evidence-based and justifiable. Another commenter believed CMS should
defer to the RUC process, especially when CMS does not have the
appropriate specialty representation to make
[[Page 78982]]
informed decisions about the RUC recommendations. They further opined
that CMS should communicate with the RUC and work to alter the process
requirements so all interested parties can work together on a desired
outcome.
In contrast, several commenters offered strong support and thoughts
in response to CMS's request for information. These commenters opined
that CMS should not view the RUC as the sole source of knowledge and
expertise to ensure that physician services are valued appropriately.
They encouraged CMS to invest in additional adjunctive sources to
ensure its recommendations are well-informed, balanced, and reflective
of the evolving healthcare environment. One commenter supported CMS in
considering another independent entity, including pharmacists and other
clinical staff, that would serve CMS in providing recommendations on
resource inputs for work and practice expense (PE) valuations and to
more accurately establish values for E/M and other physician services
that better reflect modern-day team-based health care delivery and the
actual services provided by pharmacists and other clinical staff to
provide E/M services. Other commenters greatly appreciated CMS posing
this question, as they did not believe that the AMA RUC is the entity
best positioned to provide recommendations to CMS on resource inputs
for work and PE valuations and how to establish values for E/M and
other physicians' services. They stated that the valuations established
during this process no longer represent the valuation of services for
`physicians' but all healthcare providers who bill Medicare, advanced
practice nurses, physician assistants, limited license practitioners,
and allied health professionals. They noted the valuation process
relegated them to be represented by the Health Care Professionals
Advisory Committee (HCPAC), which only has one seat on the RUC. These
commenters asserted that there are inherent conflicts in the valuation
process, which led to a historical undervaluation of E/M services, a
foundational aspect of the primary care system. They also raised
concerns about the data from surveys conducted by specialty societies
having low response rates and total number of responses, which they
claim raises questions about the representativeness of the results.
They added that the lack of public accessibility of this information is
not addressed by CMS's fee schedule notice and comment process, as the
fee schedule itself is often used the valuations determined by the RUC
as the basis for CMS's rationale. They requested CMS develop an
equitable, accessible, and accurate valuation process reflective of the
modern healthcare system, ensuring that nurse practitioners and other
providers directly billing Medicare can participate in the entirety of
the valuation process, which must be transparent and accessible for
all. Another commenter echoed concerns that there are structural flaws
with the RUC that undermine the accuracy of its recommendations,
including inherent conflicts of interest among RUC members and a
reliance on surveys from medical societies that lead to overvaluation
of certain specialty services. They also stated that current CMS
processes for valuing services lack external validation and do not
leverage a diverse, evolving data set, which would be more accurate and
comprehensive. They suggested that CMS supplement the RUC's
recommendations with additional research and external data, positioning
CMS to more actively lead the determination of relative values, with
consultation from the RUC, consistent with expert recommendations. They
recommended implementing accurate and ongoing data collection to
independently validate RVUs, establish an empirical source of
information on time and costs associated with services, and establish
an expert advisory panel within CMS to provide crucial advice on
improving valuation processes and ensure independence and transparency.
Another commenter asserted that from the very first implementation of
the PFS based on the RBRVS, there has been no CMS agency-level
commitment to ensure that both the definition and valuation of
physicians' services are based on the best evidence possible, that the
determination of relativity has internal checks and balances, and that
the entire process is publicly accountable. They and other commenters
suggested that an expert panel will be best equipped to ensure these
services are evaluated regularly, limiting the significant
redistributive effects associated with major valuation and policy
changes, as we recently saw when the outpatient E/M codes were
revalued. They stated that a regular, independent assessment of
available data and the resulting data-driven policy recommendations
would stabilize an irregular process, significantly contributing to the
declining primary care workforce.
Another commenter urged CMS to initiate the expert panel as part of
the CY 2024 PFS final rule. They stated that the transition to more
accurate, evidence-based, and accountable processes for defining
services within the PFS and their relative pricing is long overdue and
that the work to address the many distortions within the PFS should
begin as quickly as possible.
Response: We recognize that there are varying perspectives on how
to best reflect the inputs for services paid under the PFS. We
appreciate the depth of consideration different interested parties have
offered in their comments, and we will consider all the public comments
regarding the potential range of approaches CMS could take to improve
the accuracy of valuing services and how we might evaluate E/M services
with greater specificity, more regularly, and comprehensively for
future rulemaking.
3. Split (or Shared) Visits
The split (or shared) ``substantive portion'' policy for services
furnished in facility settings was reflected in subregulatory guidance
until it was withdrawn in May 2021 in response to a petition under the,
since rescinded, Good Guidance regulation (see 87 FR 44002 (February
25, 2022). In the CY 2022 PFS final rule (86 FR 65150 through 65159),
we finalized a policy for evaluation and management (E/M) visits
furnished in a facility setting to allow payment to a physician for a
split (or shared) visit (including prolonged visits), where a physician
and NPP in the same group practice provide the service together (not
necessarily concurrently) and the billing physician personally performs
a substantive portion of the visit. Commenters generally supported our
CY 2022 proposals; however, there were divided comments regarding our
proposed definition of ``substantive portion.'' Some commenters
preferred the use of medical decision making (MDM) or one of the three
key visit components as opposed to time for purposes of defining the
``substantive portion'' of the service.
a. Background
A split (or shared) visit refers to an E/M visit performed by both
a physician and an NPP in the same group practice. In the non-facility
(for example, office) setting, the rules for ``incident to'' billing
apply under this circumstance. However, ``incident to'' services are
not available for services furnished in a facility setting.
Longstanding CMS policy has been that, for split (or shared) visits in
the facility (for example, hospital) setting, the physician can bill
for the services if they perform a substantive portion of the
encounter.
[[Page 78983]]
Otherwise, the NPP would bill for the service. Section 1833(a)(1)(N) of
the Act specifies that payment is made for services furnished and
billed by a physician at 100 percent of the PFS rate, while under
section 1833(a)(1)(O)(i) of the Act, certain NPPs are paid for the
services they furnish and bill for at a reduced PFS rate (for example,
85 percent of the PFS rate).
We defined ``substantive portion'' in the CY 2022 PFS final rule
(86 FR 65152 through 65156) and provided for billing of split (or
shared) visits in certain settings (86 FR 65156 through 65157) and for
certain patient types (new and established) (86 FR 65156). After
consideration of the public comments on the CY 2022 PFS proposed rule,
we finalized a phased-in approach to this policy (86 FR 65153). For CY
2022, we finalized the definition of ``substantive portion'' as one of
the following: either one of the three key E/M elements (that is,
history, exam, or MDM) or more than half of total time. We also stated
that we would delay the full implementation of the definition of
``substantive portion'' as more than half of total time until CY 2023
(86 FR 65152 and 65153).
Additionally, in the CY 2022 PFS final rule (86 FR 65158 through
65159), we finalized our proposal to create a payment modifier
(modifier FS), to describe split (or shared) visits (see 86 FR 65158
through 65159 for this discussion). Over time, implementing and using
this modifier will better enable us to quantify split (or shared)
visits and better understand the billing patterns of practitioners that
typically furnish them. Such information is helpful to CMS for program
integrity purposes and may also inform us on whether we need to clarify
or further revise the policy for these services in future rulemaking.
We have roughly one year's worth of claims data from the time we
implemented the modifier as part of our ongoing engagement with
interested parties. We have continued to hear concerns about our intent
to implement our policy to use more than half of the total time to
define the ``substantive portion'' of a split or shared visit, and have
received requests to continue to recognize MDM as the ``substantive
portion.'' Many of these concerns specifically reference disruptions to
current team-based practice patterns, and the potential for significant
adjustments to the practice's internal processes or information systems
to allow for tracking visits based on time, rather than MDM. With these
concerns in mind, in the CY 2023 PFS final rule (87 FR 69614 through
69616), we finalized a policy to delay implementation of our definition
of substantive portion as more than half of the total practitioner time
until January 1, 2024.
After much consideration, we proposed to delay the implementation
of our definition of the ``substantive portion'' as more than half of
the total time through at least December 31, 2024, for the same reasons
outlined in the CY 2023 PFS final rule (87 FR 69614 through 69616). We
proposed maintaining the current definition of `substantive portion'
for CY 2024, which allows using any of the three key components
(history, exam, or MDM) or more than half of the total time spent to
determine who bills the visit. We stated that the additional delay
would allow interested parties to have another opportunity to comment
on this policy and would give CMS time to consider more recent feedback
and evaluate whether there is a need for additional rulemaking on this
aspect of our policy. We expressed interest in how facilities currently
implement our split (or shared) services policy in their workflows and
how facilities now account for billing practitioners' services that are
performed split (or shared). We expressed interest in better accounting
for the billing practitioner's services in team-based care clinical
scenarios. We recognized that the AMA CPT Editorial Panel was
considering revisions to aspects of split or shared visits for CY 2024
that may impact our policies, but those changes had not been finalized
before our proposed rule was published. We stated we would review the
AMA CPT Editorial Panel's changes to split or shared visits when and if
available before the final rule and in the context of our policy
proposal. We indicated that we would consider any changes that are made
by CPT and their relationship to our previously finalized policies and
whether a further implementation delay beyond CY 2024 or revision of
the definition of ``substantive portion'' is warranted.
We proposed to amend Sec. 415.140 to delay implementation of the
definition of ``substantive portion'' as more than half of the total
time through CY 2024 in the interim while we continued to analyze and
collect information from interested parties and commenters as to
whether we should permanently modify our current definition. We
proposed that the current definition of ``substantive portion'' would
apply for visits other than critical care visits furnished such that
substantive portion means either one of the three key components
(history, exam, or MDM) or more than half of the total time spent by
the physician and NPP performing the split (or shared) visit for
services furnished through the end of CY 2024.
We received public comments related to our proposal to delay the
implementation of the definition of substantive portion, as more than
half of the time spent by the physician and NPP through at least
December 31, 2024.
Below is a summary of the comments we received and our responses.
Comment: Most commenters supported at least our proposed additional
year delay in the implementation of time being used as the substantive
portion. Additionally, one commenter expressed support for the overall
goal of this policy, which is to require transparency.
Response: We thank commenters for their feedback.
Comment: While many commenters supported the delay, several asked
that our permanent policy add the option to use time or MDM to
determine who has furnished the substantive portion of the service,
which is broadly consistent with the new set of E/M codes. Many
commenters who supported using MDM stated that basing the policy solely
on time could result in administrative burden and a possible disruption
to team-based care. One commenter also noted that MDM would allow for
the physician and NPP to decide which of them will bill for the
services based on who furnished the substantive portion of the visit
and assignment of the billing provider.
Other commenters stated that the physician should always bill for
the shared visits because their level of expertise and efficiency was
medically necessary, regardless of who spent more time with the
patient. One commenter noted that if CMS is concerned that facility-
based practices will take advantage of the E/M code changes that no
longer utilize the examination elements in code selection, CMS could
still require face-to-face care by the physician to bill for the shared
visit as a simplified way to determine and audit when the physician
level of expertise was necessary and when an independent visit without
the physician was more appropriate.
Response: These comments were consistent with the public comments
that we received and addressed in our CY 2023 PFS final rule (87 FR
69614 through 87 FR 69616). We define a split (or shared) visit as an
E/M visit in the facility setting that is performed in part by both a
physician and an NPP who are in the same group practice, in accordance
with applicable laws and regulations. We note that the policy is not
about whether the physician's expertise is ``necessary'' for the visit
but
[[Page 78984]]
rather whether the physician or the NPP should bill for the service
when each of them are performing part of an E/M visit.
Comment: Several commenters expressed that the policy to define
``substantive portion'' as more than half of the total time should
never be fully implemented, other commenters asked CMS to permanently
delay the implementation of this policy, while others urged CMS to
withdraw the ``substantive portion'' policy altogether or continue the
current policy to allow use of the three key components or time to
determine who bills for the visit.
Response: We continue to believe that application of a substantive
portion policy is appropriate for purposes of determining which
clinician should bill for split (or shared) services as the higher PFS
payment rate should apply only when a physician performs the
substantive portion of the visit. Otherwise, the visit should be billed
by the NPP who performs the substantive portion of the visit.
Comment: A couple of commenters expressed that this policy is
troublesome for rural healthcare providers where the NPPs provide most
of the care, and the practitioners receive less payment for split (or
shared) visits as compared to physicians. The commenter stated this
`substantive portion' policy of more than half of total time by the
physician and NPP performing the split (or shared) visit) would
disenfranchise rural beneficiaries and providers. A few commenters
urged CMS to withdraw the ``substantive portion'' policy and continue
using its current history, exam, or medical decision-making policy and
do not believe that ``over half'' is an appropriate definition of
``substantive portion'' for the purpose of paying for split/shared
services.
Response: We appreciate the commenters' concerns and will continue
to consider the potential impact of our policy on rural or health
professional shortage areas for future rulemaking.
Comment: A few commenters expressed general concerns with the
proposed delay in implementing our revised definition of ``substantive
portion'' for split (or shared) services. Specifically, commenters
stated that each year CMS proposes a delay, the facilities and
practices spend time and resources preparing for potential changes that
never come to fruition. To mitigate this burden, commenters urged CMS
to finalize the current rules for split (or shared) visits.
Response: We note that we previously delayed finalizing the split
(or shared) policy to consider additional feedback from interested
parties, especially regarding administrative burden on professionals
and concerns about the policy potentially deterring appropriate team-
based care. Commenters continue to echo those same concerns with
requests that we continue to recognize MDM as the ``substantive
portion.'' We also acknowledge the commenters concerns surrounding the
time and resources spent to prepare for changes in their practice
patterns.
Comment: Several commenters noted that the AMA CPT Editorial Panel
was in the process of strengthening their guidance for reporting split
(or shared) visits using MDM, and this information would be included in
the 2024 CPT publication. Other commenters asked CMS to adopt the new
CPT guidance for split/shared visits and to delay its application until
January 1, 2025. One commenter expressed that having two definitions of
`substantive portion' will create confusion, and stated that it is
important for physicians to stick with one set of guidelines in
reporting services.
Response: Over the past 2 years, CPT has reviewed and revised its
guidelines involving E/M visits, including split (or shared) services.
CMS has been concurrently reviewing those additions, revisions, and
changes made by CPT, and addressing and incorporating them as
appropriate for Medicare billing through our rulemaking process to
provide greater alignment between the CPT E/M Guidelines and PFS
billing rules for E/M services, including the split (or shared) visits.
We note that the CPT Editorial Panel recently issued its revised
guidelines for ``split or shared visits'' for CY 2024. Specifically,
the Editorial Panel changed the definition of a '' split or shared
visit'' to refer to the substantive portion of a service as either more
than half of the total time spent by the physician and NPP performing
the split (or shared) visit or a substantive part of the medical
decision making, and to indicate that these guidelines should be
applied to determine whether the physician or NPP may bill for the
service. For CY 2024, the CPT E/M Guidelines for billing split or
shared services now state that ``physician(s) and other QHP(s) may act
as a team in providing care for the patient, working together during a
single E/M service. The split or shared visits guidelines are applied
to determine which professional may report the service. If the
physician or other QHP performs a substantive portion of the encounter,
the physician or other QHP may report the service. If code selection is
based on total time on the date of the encounter, the service is
reported by the professional who spent the majority of the face-to-face
or non-face-to-face time performing the service. For the purpose of
reporting E/M services within the context of team-based care,
performance of a substantive part of the MDM requires that the
physician(s) or other QHP(s) made or approved the management plan for
the number and complexity of problems addressed at the encounter and
takes responsibility for that plan with its inherent risk of
complications and/or morbidity or mortality of patient management. By
doing so, a physician or other QHP has performed two of the three
elements used in the selection of the code level based on MDM. If the
amount and/or complexity of data to be reviewed and analyzed is used by
the physician or other QHP to determine the reported code level,
assessing an independent historian's narrative and the ordering or
review of tests or documents do not have to be personally performed by
the physician or other QHP, because the relevant items would be
considered in formulating the management plan. Independent
interpretation of tests and discussion of management plan or test
interpretation must be personally performed by the physician or other
QHP if these are used to determine the reported code level by the
physician or other QHP'' (2024 CPT Codebook, pg. 6). We remind our
readers that for CY 2023, the CPT E/M Guidelines define a shared or
split visit as a visit in which a physician and other qualified health
care professional(s) (QHP) both provide the face-to-face and non-face-
to-face work related to the visit. In past discussions in rulemaking on
this issue, we stated that MDM was not easily attributed to a single
physician or NPP when the work is shared because MDM is not necessarily
quantifiable and could vary depending on patient characteristics (for
example, risk), in contrast to time, which we believe is a more precise
factor than MDM to use as a basis for deciding which practitioner
performs the ``substantive portion of the visit.'' However, given these
recent changes in the CPT Guidelines for split (or shared) visits and
our interest in reducing coding and billing administrative burden on
health professionals through continued alignment with revised
overarching guidelines for E/M visits, we are reconsidering our policy
for defining `substantive portion' as it applies to split or shared
visits.
After reviewing the revisions made by the AMA CPT Editorial Panel
that were included in the 2024 CPT codebook
[[Page 78985]]
publication, specifically the Evaluation and Management (E/M) Services
Guidelines language surrounding ``substantive portion'' for split (or
shared) services, and in light of public comments on our policies, we
agree that we should align our definition of substantive portion with
the CPT E/M guidelines for this service. Although we continue to
believe there can be instances where MDM is not easily attributed to a
single physician or NPP when the work is shared, we expect that whoever
performs the MDM and subsequently bills the visit would appropriately
document the MDM in the medical record to support billing of the visit.
Generally, commenters were in support of CMS delaying for an additional
year the requirement to use total time to determine which practitioner
performs the substantive portion of the service. However, we also heard
concerns about CMS implementing this definition of substantive portion
at all, with many requests that we also recognize MDM as the
substantive portion of the visit. In consideration of the changes made
by the CPT Editorial Panel, we are revising our definition of
``substantive portion'' of a split (or shared) visit to reflect the
revisions to the CPT E/M guidelines. Specifically, for CY 2024, for
purposes of Medicare billing for split (or shared) services, the
definition of ``substantive portion'' means more than half of the total
time spent by the physician and NPP performing the split (or shared)
visit, or a substantive part of the medical decision making as defined
by CPT. We continue to note that for critical care visits which do not
use MDM, ``substantive portion'' continues to mean more than half of
the total time spent by the physician and NPP performing the split (or
shared) visit (42 CFR 415.140). In summary, we are finalizing a policy
that reflects a revised definition of ``substantive portion'' of a
split (or shared) visit to reflect the revisions to the CPT E/M
guidelines, such that for Medicare billing purposes, the ``substantive
portion'' means more than half of the total time spent by the physician
and NPP performing the split (or shared) visit, or a substantive part
of the medical decision making except concerning critical care visits
which do not use MDM and only use time, ``substantive portion''
continues to mean more than half of the total time spent by the
physician and NPP performing the split (or shared) visit. We will
revise our regulations at 42 CFR 415.140 to reflect this change for
split (or shared) visits. We note that we are finalizing this policy
for CY 2024, in part, to avoid the administrative burden, as described
by commenters, that would otherwise be present for facilities and
practices that spend time and resources preparing for potential policy
changes that are delayed year after year. If warranted, we would
address any subsequent change in policy through notice and comment
rulemaking.
G. Geographic Practice Cost Indices (GPCIs)
1. Background
Section 1848(e)(1)(A) of the Act requires CMS to develop separate
Geographic Practice Cost Indices (GPCIs) to measure relative cost
differences among localities compared to the national average for each
of the three fee schedule components (that is, work, practice expense
(PE), and malpractice (MP)). Section 1848(e)(1)(E) of the Act provides
for a 1.0 floor for the work GPCIs for the purposes of payment for
services furnished on or after January 1, 2004, and before January 1,
2024. Congress recently extended the 1.0 work GPCI floor only through
December 31, 2023, in division CC, section 101 of the Consolidated
Appropriations Act, 2021 (Pub. L. 116-260, enacted December 27, 2020).
Therefore, the CY 2024 work GPCIs and summarized GAFs do not reflect
the 1.0 work floor. See Addenda D and E to this final rule for the CY
2024 GPCIs and summarized GAFs. These Addenda are available on the CMS
website under the supporting documents section of the CY 2024 PFS final
rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
2. Review of the California Fee Schedule Areas Used for Payment for CY
2024
Section 220(h) of the Protecting Access to Medicare Act (PAMA)
(Pub. L. 113-93, April 1, 2014) added a new section 1848(e)(6) to the
Act that modified the fee schedule areas used for payment purposes in
California beginning in CY 2017. Prior to CY 2017, the fee schedule
areas used for payment in California were based on the revised locality
structure that was implemented in 1997 as previously discussed.
Beginning in CY 2017, section 1848(e)(6)(A)(i) of the Act required that
the fee schedule areas used for payment in California must be
Metropolitan Statistical Areas (MSAs) as defined by the Office of
Management and Budget (OMB) as of December 31 of the previous year; and
section 1848(e)(6)(A)(ii) of the Act required that all areas not
located in an MSA must be treated as a single rest-of-State fee
schedule area. The resulting modifications to California's locality
structure increased its number of fee schedule areas from 9 under the
previous locality structure to 27 under the MSA-based locality
structure; although for the purposes of payment, the actual number of
fee schedule areas under the MSA-based locality structure is 32. We
refer readers to the CY 2017 PFS final rule (81 FR 80267) for a
detailed discussion of this operational decision.
Section 1848(e)(6)(D) of the Act defined transition areas as the
counties in fee schedule areas for 2013 that were in the rest-of-State
locality, and locality 3, which was comprised of Marin, Napa, and
Solano counties. Section 1848(e)(6)(B) of the Act specified that the
GPCI values used for payment in a transition area are to be phased in
over 6 years, from 2017 through 2022, using a weighted sum of the GPCIs
calculated under the new MSA-based locality structure and the GPCIs
calculated under the PFS locality structure that was in place prior to
CY 2017. That is, the GPCI values applicable for these areas during
this transition period were a blend of what the GPCI values would have
been for California under the locality structure that was in place
prior to CY 2017, and what the GPCI values would be for California
under the MSA-based locality structure. For example, in CY 2020, which
represented the fourth year of the transition period, the applicable
GPCI values for counties that were previously in the rest-of-State
locality or locality 3 and are now in MSAs were a blend of \2/3\ of the
GPCI value calculated for the year under the MSA-based locality
structure, and \1/3\ of the GPCI value calculated for the year under
the locality structure that was in place prior to CY 2017. The
proportions continued to shift by \1/6\ in each subsequent year so
that, by CY 2021, the applicable GPCI values for counties within
transition areas were a blend of \5/6\ of the GPCI value for the year
under the MSA-based locality structure, and \1/6\ of the GPCI value for
the year under the locality structure that was in place prior to CY
2017. Beginning in CY 2022, the applicable GPCI values for counties in
transition areas were the values calculated solely under the new MSA-
based locality structure; therefore, the phase-in for transition areas
is complete. Additionally, section 1848(e)(6)(C) of the Act establishes
a hold harmless requirement for transition areas beginning with CY
2017; whereby, the applicable GPCI values for a year under the new MSA-
based locality structure may not be less than what they would
[[Page 78986]]
have been for the year under the locality structure that was in place
prior to CY 2017. There are 58 counties in California, 50 of which were
in transition areas as defined in section 1848(e)(6)(D) of the Act. The
eight counties that were not within transition areas are: Orange; Los
Angeles; Alameda; Contra Costa; San Francisco; San Mateo; Santa Clara;
and Ventura counties. We noted that while the phase-in for transition
areas is no longer applicable, the hold harmless requirement is not
time-limited, and therefore, is still in effect.
For the purposes of calculating budget neutrality and consistent
with the PFS budget neutrality requirements as specified under section
1848(c)(2)(B)(ii)(II) of the Act, in the CY 2017 PFS final rule (81 FR
80266), we finalized the policy to start by calculating the national
GPCIs as if the fee schedule areas that were in place prior to CY 2017
are still applicable nationwide; then, for the purposes of payment in
California, we override the GPCI values with the values that are
applicable for California consistent with the requirements of section
1848(e)(6) of the Act. This approach to applying the hold harmless
requirement is consistent with the implementation of the GPCI floor
provisions that have previously been implemented--that is, as an after-
the-fact adjustment that is made for purposes of payment after both the
GPCIs and PFS budget neutrality have already been calculated.
Additionally, section 1848(e)(1)(C) of the Act requires that, if
more than 1 year has elapsed since the date of the last GPCI
adjustment, the adjustment to be applied in the first year of the next
adjustment shall be \1/2\ of the adjustment that otherwise would be
made. For a comprehensive discussion of this provision, transition
areas, and operational considerations, we refer readers to the CY 2017
PFS final rule (81 FR 80265 through 80268).
a. Refinement to Number of Unique Fee Schedule Areas in California for
CY 2024
In the CY 2020 final rule (84 FR 62622), a commenter indicated that
some of the distinct fee schedule areas that were used during the
period between CY 2017 and CY 2018 are no longer necessary.
Specifically, with regard to the Los Angeles-Long Beach-Anaheim MSA,
which contains 2 counties (across two unique locality numbers, 18 and
26) that are not transition areas, we acknowledge that we only needed
more than one unique locality number for that MSA for payment purposes
in CY 2017, which was the first year of the implementation of the MSA-
based payment locality structure. Neither of the counties in the Los
Angeles-Long Beach-Anaheim MSA (Orange County and Los Angeles County)
are transition areas under section 1848(e)(6)(D) of the Act. Therefore,
the counties were not subject to the aforementioned GPCI value
incremental phase-in (which is no longer applicable) or the hold-
harmless provision at section 1848(e)(6)(C) of the Act. Similarly, the
San Francisco-Oakland-Berkeley MSA contains four counties--San
Francisco, San Mateo, Alameda, and Contra Costa counties--across three
unique locality numbers, 05, 06, and 07. These counties are not
transition areas and will receive the same GPCI values, for payment
purposes, going forward. In response to the comment, we acknowledged
that we did not propose any changes to the number of fee schedule areas
in California, but would consider the feasibility of a technical
refinement to consolidate into fewer unique locality numbers; and if we
determined that consolidation was operationally feasible, we would
propose the technical refinement in future rulemaking. This refinement
would ultimately change the number of distinct fee schedule areas for
payment purposes in California from 32 to 29. In the CY 2023 PFS
proposed rule (87 FR 46008), we proposed to identify the Los Angeles-
Long Beach-Anaheim MSA, containing Orange County and Los Angeles
County, by one unique locality number, 18, as opposed to two, thus
retiring locality number 26, as it is no longer needed. Similarly, we
proposed to identify the San Francisco-Oakland-Berkeley MSA containing
San Francisco, San Mateo, Alameda, and Contra Costa counties by one
unique locality number, 05, as opposed to three, thus retiring locality
numbers 06 and 07, as they are no longer needed. Additionally, we noted
that we would modify the MSA names as follows: the San Francisco-
Oakland-Berkeley (San Francisco Cnty) locality (locality 05) would
become San Francisco-Oakland-Berkeley (San Francisco/San Mateo/Alameda/
Contra Costa Cnty), and Los Angeles-Long Beach-Anaheim (Los Angeles
Cnty) locality (locality 18) would become Los Angeles-Long Beach-
Anaheim (Los Angeles/Orange Cnty). We noted that because Marin County
is in a transition area and subject to the hold harmless provision at
section 1848(e)(6)(C) of the Act, we needed to retain a unique locality
number for San Francisco-Oakland-Berkeley (Marin Cnty), locality 52.
Based on support from commenters in the CY 2023 PFS final rule (87 FR
69621), we finalized to identify the Los Angeles-Long Beach-Anaheim
MSA, containing Orange County and Los Angeles County, by one unique
locality number, 18, and the San Francisco-Oakland-Berkeley MSA
containing San Francisco, San Mateo, Alameda, and Contra Costa counties
by one unique locality number, 05, as proposed. We noted that, while we
believed these changes were appropriate to consolidate fee schedules
areas that are no longer operationally necessary, we were unable to
operationalize these changes for CY 2023 due to timing constraints
relating to the actions and coordination with the various systems
maintainers required to effectuate changes to claims processing (87 FR
69621). Therefore, for CY 2023, there were no changes to the existing
locality numbers 05, 06, 08, 18, or 26. We noted in the CY 2023 PFS
final rule that we would operationalize these finalized changes for CY
2024. We reiterate here that we are operationalizing these locality
number changes for CY 2024 via instruction to the MACs, and therefore,
locality numbers 06, 07, and 26 will no longer be used for the PFS
starting January 1, 2024. We note that these changes, when
operationalized, do not have any payment implications under the PFS
because these counties are not transition areas and will receive the
same GPCI values, for PFS payment purposes, going forward.
The following is a summary of the public comments received on the
CY 2024 GPCIs and our responses:
Comment: We received several comments that were outside the scope
of the proposed rule, and some are reiterations from last year's GPCI
update.
Response: We appreciate the feedback from commenters. We note that
we responded to these comments in the CY 2023 PFS final rule (87 FR
69630 through 69634) and will not be summarizing or responding to them
in this final rule. Also, it is important to note that although the
comments did not relate to any proposals for CY 2024, we will take them
into consideration for potential future rulemaking.
Comment: One commenter encouraged CMS to consider the potential
effects of the COVID-19 pandemic on the malpractice GPCIs. The
commenter asked that CMS withdraw the MP component update from the CY
2023 PFS final rule and reinstate the prior MP component in the CY 2024
PFS final rule.
Response: We appreciate the feedback from the commenter. We did not
make any proposals associated with the MP
[[Page 78987]]
GPCI or MP RVUs, but will take these comments into consideration for
potential future rulemaking. We encourage commenters to submit comments
on the next proposed MP GPCI and MP RVU update which is anticipated for
CY 2026.
Comment: Some commenters highlighted the expiration of the work
GPCI floor of 1.0 on December 31, 2023, and expressed concern with the
CY 2024 work GPCIs that are calculated without the work GPCI floor in
place. Commenters asked that CMS consider a two- or three-year phase in
of the work GPCI floor expiration and recalculate the CY 2024 work
GPCIs based on a transition period if the statutory floor is allowed to
expire. Some commenters asked that CMS implement a permanent policy to
set a work GPCI floor so statutory extensions would no longer be
necessary. Some of the commenters stated an objection to any changes
that could have a negative impact on rural areas, such as the
expiration of the work GPCI floor.
Response: We appreciate the commenters' feedback. The 1.0 work GPCI
floor is required by statute and set to expire on December 31, 2023. We
do not have the authority to extend the 1.0 work GPCI floor beyond
December 31, 2023, or to establish a permanent policy to establish the
1.0 work GPCI floor. We note that 34 States have statewide payment
localities, which means that the same geographic adjustment applies to
PFS payments throughout the State without any differential between
rural and urban areas.
Comment: One commenter stated that there is a lack of transparency
into the GPCI data and methodology used to derive the GPCIs. The
commenter stated that they cannot accurately validate CMS' GPCI
calculations because there is little transparency and access to the
data and methods used. The commenter stated that CMS provided these
data prior to 2020 and that they used it to reproduce and validate the
CMS methodology for calculating the GPCIs each year.
Response: We direct the commenter to the step-by-step instructions
provided in the final report entitled, ``Final Report for the CY 2023
Update of GPCIs and MP RVUs for the Medicare PFS,'' which is available
on our website located under the supporting documents section for the
CY 2023 PFS final rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html. We also refer readers
to Table 4.A.1: Summary of Elements Required for GPCI Calculation in
the final report, and the discussion in the CY 2023 PFS final rule (87
FR 69621) for the data sources used for the work GPCI and each
component of the practice expense GPCIs noted in the CY 2023 PFS final
rule, we discussed the years and timeframes of data used from each
source and provided web links to the publicly-available data sources
used in the CY 2023 GPCI update. Consistent with the information
provided for previous GPCI updates, we also provided the methodological
parameters, as well as an overview of how we develop each GPCI
component in the final report. We also note that there is detailed
information about the budget neutrality adjustment and statutory floors
that are applied after the budget neutrality adjustment in the note,
``CY 2023 GPCI Update Note_County_Data,'' on our website, also located
under the supporting documents section for the CY 2023 PFS final rule
at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
We remind the commenter that, in response to commenters' concerns
expressed in rulemaking for the CY 2020 GPCI update, we added more
detailed descriptions of the steps in the final report entitled,
``Final Report for the CY 2020 Update of GPCIs and MP RVUs for the
Medicare Phys Fee Sched_v19Feb2020,'' which is available on the CMS
website under the downloads section of the CY 2020 PFS final rule at
https://www.cms.gov/Medicare/Medicare-Fee-forService-Payment/PhysicianFeeSched/index.html, to assist interested parties in
navigating these data. Additionally, as part of our ongoing commitment
to transparency, we post the county-level data that we use to develop
the proposed GPCIs, which allows interested parties to further examine
and replicate our GPCI methodology. This file is available on the CMS
website on our website under the Downloads section, titled ``CY 2023
Proposed Rule GPCI County-Level Data File.''
We did not receive any comments about the announcement in the CY
2024 PFS proposed rule of our planned operationalization of the changes
to the California localities that we finalized in the CY 2023 PFS final
rule beginning for CY 2024. Therefore, we are proceeding with
implementation as planned for CY 2024. We note that these changes to
California localities, when operationalized, do not have any payment
implications under the PFS. The final CY 2024 GPCIs and summarized GAFs
in Addenda D and E to this final rule reflect the California locality
changes, and locality numbers 06, 07, and 26 are not present in these
Addenda for CY 2024.
H. Payment for Skin Substitutes
1. Background
In the CY 2023 PFS proposed rule, CMS outlined several objectives
related to refining skin substitute policies under Medicare, including:
(1) ensuring a consistent payment approach for skin substitute products
across the physician office and hospital outpatient department setting;
(2) ensuring that appropriate HCPCS codes describe skin substitute
products; (3) using a uniform benefit category across products within
the physician office setting, regardless of whether the product is
synthetic or comprised of human or animal-based material, to
incorporate more consistent payment methodologies; and (4) maintaining
clarity for interested parties on CMS skin substitutes policies and
procedures. When considering potential changes to policies involving
skin substitutes, we noted that we believe it would be appropriate to
take a phased approach over multiple rulemaking cycles to examine how
we could appropriately incorporate skin substitutes as supplies under
the PFS ratesetting methodology. Generally, we determine the direct PE
for a specific service by adding the costs of the direct resources
(that is, the clinical staff, medical supplies, and medical equipment)
typically involved with furnishing that service. For a detailed
explanation of the direct PE methodology, including examples, we
referred readers to the 5-year review of work RVUs under the PFS and
proposed changes to the PE methodology CY 2007 PFS proposed notice (71
FR 37242) and the CY 2007 PFS final rule with comment period (71 FR
69629).
Similar to the way we assess costs for other incident to supplies,
our approach to identifying appropriate PE direct costs for skin
substitute products may include: reviewing various sources for price
information, including performing market research, reviewing invoices
submitted by interested parties, or reviewing cost information on
Medicare claims. Further, we would assess how the incident to supplies
are billed or represented while also considering the service with which
it is typically furnished. For example, if the supply is billed
separately, with the base service, or usually bundled and incident to
the base service. Also, we would consider whether there are different
supply costs or other meaningful stratifications (for example, a unit
of measure or product type) that should be accounted for as we develop
direct PE costs, considering how the base service is furnished.
We solicited comments on these approaches under our PFS ratesetting
[[Page 78988]]
methodology as potential methods to establish appropriate payment for
skin substitute products under the PFS.
We received public comments on these potential approaches. The
following is a summary of the comments we received and our responses.
Comment: The majority of commenters were in support of our efforts
to achieve a consistent payment approach for skin substitute products
across different settings of care. Additionally, many commenters stated
that they appreciated the opportunity to further engage with CMS on
skin substitute policies through the CMS Skin Substitutes Town Hall in
January of 2023.
Response: We thank commenters for their support and for their
participation in the CMS Skin Substitutes Town Hall, which was held
virtually on January 18, 2023. More information regarding the CMS Skin
Substitutes Town Hall such as links to recording and transcripts is
available at https://www.cms.gov/medicare/payment/fee-schedules/
physician/skin-
substitutes#:~:text=The%20CMS%20Skin%20Substitutes%20Town,Physician%20Fe
e%20Schedule%20(PFS).
Comment: Many commenters opposed the idea of packaging and paying
for skin substitutes as supplies and recommended that CMS retain
separate coding and payment for these products. The commenters did not
view skin substitutes as supplies because the products are affixed to a
wound, and their function is similar to a drug or biologic.
Response: CMS recognizes there are numerous factors to consider
when establishing a consistent payment approach for all skin substitute
products. Additionally, CMS will take into consideration concerns
raised by interested parties to help inform how we might best achieve
an appropriate payment approach for future rulemaking.
Comment: Many commenters opposed to treating skin substitute
products as supplies recommended that CMS instead assign HCPCS Q codes
to all skin substitute products and pay for all skin substitute
products using the ASP+6% payment methodology. Some commenters
expressed their support for separate payment under the ASP +6% payment
methodology by citing an OIG report (OEI-BL-23-00010) that highlighted
significant cost savings for Part B payment amounts if ASP data were to
be reported by all skin substitute manufacturers. More information
regarding this OIG report is available at https://oig.hhs.gov/oei/reports/OEI-BL-23-00010.asp.
Response: We appreciate the feedback from commenters. We maintain
our commitment to establishing a consistent payment approach for all
skin substitute products.
Comment: A few commenters noted that most skin substitute products
in the physician office setting meet the statutory definition of a
biological product and question whether this move is legal under the
mandatory payment laws for drugs and biologicals. Another commenter
noted that CMS must support the reversal of prior policy under the
Administrative Procedure Act.
Response: The CY 2024 PFS proposed rule includes no proposals for
skin substitute polices. Instead, CMS solicited comments from
interested parties to help us consider an approach to pricing these
products as supplies.
Comment: Some commenters noted that CMS did not provide enough
information on these different pricing approaches in order to
meaningfully comment.
Response: We remind commenters that, in response to concerns
expressed by commenters in CY 2023 PFS rulemaking, we included more
information in the CY 2024 PFS proposed rule on how CMS could
incorporate skin substitutes as a supply under the PFS and solicited
comments on the different approaches we could consider. Additionally,
we refrained from making any proposal for CY 2024 to allow more
opportunities for us to receive and consider feedback from interested
parties, including through the Skin Substitutes Town Hall and the CY
2024 PFS proposed rule.
Comment: A few commenters noted that as CMS reviews skin substitute
policies, the terminology should not be changed to ``wound care
management products'' and that skin substitutes is the appropriate
term. Additionally, one commenter suggested creating a new taxonomy
code for wound care specialists to acknowledge the providers delivering
this specific type of enhanced care. Lastly, one commenter recommended
that CMS require the physician applying the product to the wound cover
the entire wound surface area in order to receive payment for the
application procedure.
Response: We appreciate the commenters' feedback.
2. Sources of Price Information
We have refined specific PE data inputs in recent years, using
market research and publicly available data (for example, market
research on medical supply and equipment items and BLS data to update
clinical labor wages) to update the direct PE data inputs used in the
PFS ratesetting process. Historically, the PFS uses a variety of
sources to help inform payment for specific services that are then used
to establish direct PE inputs. Direct PE inputs may derive from
assessing the current value of products on the market, which may be
achieved by utilizing Average Sales Price (ASP) data or Wholesale
Acquisition Cost data (WAC). Since some manufacturers self-report ASP/
WAC data at the end of every quarter, this may help to inform CMS of
the current market value of these products.
We also review submitted invoices, which reflect the specific cost
of products that practitioners are paying manufacturers for these
products. We noted in the CY 2011 PFS final rule (75 FR 73205) that we
update supply and equipment prices through an invoice submission
process. In this process, we consider the invoice information and
incorporate it into our direct costs database if the submitted pricing
data indicates the typical market price of the supply or equipment
item.
While performing market research and the invoice submission process
are different methods to derive pricing for specific products,
reviewing cost information on Medicare claims may also help us identify
the variability in product costs. For example, assessing detailed cost
information on claims with skin substitute products could inform how
these products are priced and allow us to consider how the skin
substitutes are typically furnished and where these services are
performed. This information would enable us to refine our payment
policies for these products across different care settings.
We solicited comment on the cost-gathering approaches we described
in order to inform how we would establish direct PE inputs for skin
substitute products and appropriately develop payment rates for
physicians' services that involve furnishing skin substitute products.
The following is a summary of the comments we received and our
responses.
Comment: A few commenters noted that if CMS were to consider skin
substitute products as direct PE inputs, then ASP data would be the
best estimate of cost.
Response: We appreciate this feedback from commenters.
Comment: Some commenters mentioned that to capture supplies in the
PE RVU methodology, CMS must consider the following: the single use
supply item, unit of measurement, per unit price, and the quantity of
the
[[Page 78989]]
specified item. These commenters also believe the PE methodology relies
on evaluation of a `typical service' for a single-use supply item, but
because skin substitute products may change based on patient-specific
factors and can vary by application code, commenters state that no
single skin substitute product stands out as ``typical.'' Additionally,
one commenter noted that claims data show variations in the number of
product units reported per claim and the per unit payments for
products.
Response: We thank these commenters for their feedback and will
take this information into consideration.
3. Approaches to Billing
We acknowledged that there are various approaches that we could use
to identify and establish direct cost inputs for the skin substitute
products. We are also considering how to account for these products'
variability and resource costs, especially as new products increasingly
become available.
Similar to the way different sources of information can influence
cost information for supplies, specifically considering variables such
as different units of measurement, product type, product composition,
or in what clinical circumstances the product is used, for example,
would help us appropriately reflect costs in payment for the services
that include the specific supply. We believe this to be pertinent to
any proposal to pay for skin substitute products. For instance,
grouping the direct costs for particular skin substitute products based
on the typically associated application procedure could help us
systematically incorporate the resource costs involved for different
product billing scenarios. This approach can be seen in the Outpatient
Prospective Payment System (OPPS), where a high-cost/low-cost system is
used for skin substitute products billed with a specific procedure code
based on their cost grouping.
Alternatively, when services and products are not performed
frequently enough to be grouped, retaining separate procedure coding
can help inform specificity and granularity for coding and payment of
these services. Specifically, we could create separate procedure coding
for specific product types, which could be billed with the appropriate
skin substitute application services. We would account for cost
variability for the different products (that is, establishing
individual or group direct cost profiles and allocating direct cost
inputs based on these groupings) under any combination of approaches
discussed above. We could also review the unit of measurement for
billed products, as available in our internal data or received in
submissions, and create direct cost groupings for the products based on
the reviewed/billed units of measurement. We could also establish
direct cost inputs by employing our standard `crosswalk' method using
information from interested parties. Specifically, we would derive PE
inputs by reviewing similarly resourced services to establish RVUs for
a service that includes the cost of the skin substitute products and
other information to account for the physician's work in furnishing the
skin substitute product. We would employ this method to establish
payment for individual services that include specific skin substitute
products or services that describe cost groupings of similarly priced
skin substitute products. As we have discussed in prior rulemaking, we
believe that the nature of the PFS relative value system is such that
all services are appropriately subject to comparisons to one another.
There is a long history of using crosswalk codes for this kind of
valuation under the PFS, which is generally established through notice
and comment rulemaking.
We solicited comment on how these methods may help reflect the
resource costs involved with skin substitute products as furnished with
different skin application procedures. The following is a summary of
the comments we received and our responses.
Comment: The majority of commenters were concerned with the idea of
incorporating skin substitute products into the PE as they believe this
would exert pressure on all other PE RVUs, resulting in cuts to other
areas of physician reimbursement due to budget neutrality. Commenters
raised this concern to highlight that packaging skin substitute
products in an office setting could lead to decreased patient access.
One commenter suggested that if CMS were to incorporate skin substitute
products in direct PE, we should ensure that it does not result in
budget neutrality reductions.
Response: As stated in the CY 2024 PFS proposed rule, our goal is
to achieve a consistent payment approach for skin substitute products
that does not negatively impact beneficiary access. We recognize the
budget neutrality concerns from interested parties and note that
commenters raised similar concerns in the CY 2022 PFS final rule when
we finalized the implementation of the clinical labor pricing update.
In response, we noted that the PFS is a resource-based relative value
payment system that necessarily relies on accuracy in the pricing of
resource inputs. We also noted that for many services that involve
proportionally more clinical labor, payment rates were reduced as a
result of the prior market-based supply and equipment pricing update,
and payment rates will increase with the clinical labor pricing update,
due to the same PFS budget neutrality requirements (86 FR 65025 through
65027). Therefore, any changes to the RVU does not necessarily result
in negative consequences for other areas of physician reimbursement.
Comment: A few comments suggested that CMS should include
additional Part B funding to account for the change in methodology, as
well as work with the AMA CPT Editorial Panel/RVS Update Committee to
address potential changes. A few commenters also recommended that CMS
mirror the existing OPPS reimbursement methodology for skin
substitutes, where payment is based on a high cost/lost cost model.
Response: We thank these commenters for their suggestions.
Comment: Some commenters offered alternative suggestions such as to
pay for high-cost disposable supplies priced at more than $500 using
appropriate HCPCS codes, where pricing of these supplies is based on a
transparent process that is annually reviewed and updated.
Additionally, one commenter recommended that CMS replace application
HCPCS codes 15271-15278 with newer, temporary codes to describe the
more complex wound procedures and offer revisions to the sizing
increments, for example: G5271-G5XXX Application of cellular and/or
tissue-based product graft to trunk, arms, legs; G5275-G 5XXX
Application of cellular and/or tissue-based product graft to face,
scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/
or multiple digits.
Response: We thank these commenters for these suggestions.
Comment: Some commenters also stated that in order for interested
parties to meaningfully comment on the different pricing methodologies
for skin substitute products, CMS should: (1) explain specific direct
inputs CMS proposes to incorporate into each HCPCS code that may
include a skin substitute as a supply (HCPCS 15271-15278 or replacement
codes if established); (2) provide information on estimates of proposed
rates; (3) describe the valuation of the application procedure code and
any redistribution effects on other PFS services with PE RVUs; and (4)
provide the impact that the proposal will have on vulnerable
populations.
Response: We did not propose any policies for skin substitutes in
the CY
[[Page 78990]]
2024 PFS proposed rule, so did not include specific proposed direct
resource inputs or pricing information, or any impact analysis.
We will consider the suggestions and concerns raised by commenters
to help inform future rulemaking. We will also continue our dialogue
with interested parties,with our continued goal to achieve a consistent
payment approach for skin substitute products across different sites of
service.
I. Supervision of Outpatient Therapy Services, KX Modifier Thresholds,
Diabetes Self-Management Training (DSMT) Services by Registered
Dietitians and Nutrition Professionals, and DSMT Telehealth Services
1. Supervision of Outpatient Therapy Services in Private Practices
(a) Remote Therapeutic Monitoring for Physical Therapists and
Occupational Therapists in Private Practice
In the CY 2023 PFS final rule, we finalized new policies allowing
Medicare payment for remote therapeutic monitoring (RTM) services,
including allowing RTM services to be furnished under general
supervision (87 FR 69649). RTM refers to the use of a device to monitor
a patient's health or response to treatment using non-physiological
data (please see a more detailed list of RTM services at section II.D.
of this proposed rule). The current regulations, however, at Sec. Sec.
410.59(a)(3)(ii) and 410.60(a)(3)(ii) specify that all occupational and
physical therapy services are performed by, or under the direct
supervision of, the occupational or physical therapist, respectively,
in private practice. These regulations make it difficult for physical
therapists in private practice (PTPPs) and occupational therapists in
private practice (OTPPs) to bill for the RTM services performed by the
physical therapist assistants (PTAs) and occupational therapy
assistants (OTAs) they are supervising since the PTPP or OTPP must
remain immediately available when providing direct supervision of PTAs
and OTAs (even though we noted in the CY 2022 PFS final rule that PTPPs
and OTPPs were intended to be among the primary billers of RTM services
(86 FR 65116)). We designated the RTM codes as ``sometimes therapy''
codes (originally in the CY 2022 PFS final rule (86 FR 65116)), meaning
that these services may be furnished outside a therapy plan of care
when they are performed by physicians and certain NPPs where their
State practice includes the provision of physical therapy, occupational
therapy, and/or speech-language pathology services. Because we did not
propose revisions to Sec. Sec. 410.59 and 410.60 last year for OTPPs
and PTPPs, we proposed to establish an RTM-specific general supervision
policy at Sec. Sec. 410.59(a)(3)(ii) and (c)(2) and 410.60(a)(3)(ii)
and (c)(2) to allow OTPPs and PTPPs to provide general supervision only
for RTM services furnished by their OTAs and PTAs, respectively.
We also noted that Medicare requires each therapist in private
practice to meet the requirements specified in our current regulations
at Sec. Sec. 410.59(c) and 410.60(c) to qualify under Medicare as a
supplier of outpatient occupational therapy or physical therapy
services. Given that occupational therapists (OTs) and physical
therapists (PTs) who are not enrolled and working as employees of OTPPs
or PTPPs do not meet these requirements, we believe they should
continue to function under direct supervision of the OTPP or PTPP. This
is consistent with the Medicare Benefit Policy Manual, Pub. 100-02,
Chapter 15, section 230.4.B, which states that in private practice,
OTPPs and PTPPs must provide direct supervision of all services,
including those furnished by OTs and PTs who are not yet enrolled in
Medicare (even if they meet the other requirements for occupational
therapists and physical therapists at 42 CFR part 484). As such, we
proposed to retain the OTPP and PTPP direct supervision requirement for
unenrolled PTs or OTs by clarifying that the RTM general supervision
regulation at Sec. Sec. 410.59(c)(2) and 410.60(c)(2) applies only to
the OTA and PTA and does not include the unenrolled OT or PT. We
solicited comment on this specific proposal as we want to know more
about how this policy is now functioning with OTs and PTs who are not
enrolled and our proposal to maintain this longstanding policy for
direct supervision.
We 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 allow PTs and
OTs in private practice to provide general supervision for RTM
services. Many commenters urged us to finalize our proposal.
Response: We appreciate the support for our proposed policy from
the commenters.
Comment: Some commenters reported that the current direct
supervision requirement makes it challenging to use PTAs or OTAs to
deliver RTM services and stated that allowing general supervision of
PTAs and OTAs in private practice settings provides a safe way for
patients to receive RTM services.
Response: We appreciate the support for our proposed policy from
the commenters.
Comment: Some commenters noted that our proposal aligns with the
general supervision policy we finalized beginning in CY 2023 for RTM
services furnished by physicians and other practitioners, while a few
commenters noted that we did not propose to allow general supervision
of PTAs and OTAs last year.
Response: We thank the commenters for their views and clarify that
instead of the four proposed G-codes, two of which would encompass PTs,
OTs, and SLPs in private practice, we finalized an alternate RTM
general supervision policy to begin January 1, 2023. As such, we had
not proposed a regulatory change for PTAs and OTAs employed in private
practices of PTs and OTs.
Comment: One commenter supported our proposal to retain the OTPP
and PTPP direct supervision requirement for unenrolled PTs or OTs. We
did not receive any responses to our comment solicitation about how
this policy now functions with OTs and PTs who are not enrolled.
Response: We appreciate the support for our proposed policy from
the commenter.
After consideration of public comments, we are finalizing our
proposal for RTM services to allow general supervision of OTAs and PTAs
by OTs and PTs in private practice; and finalizing the proposal to
continue the requirement for direct supervision of unenrolled PTs and
OTs, including for RTM services. We are also finalizing the amendments
to the corresponding regulation text at Sec. Sec. 410.59 and 410.60 as
proposed.
We believe this proposal will increase access to these remotely
provided services performed by PTAs and OTAs under the general
supervision furnished by PTPPs and OTPPs, and aligns the regulatory
text at Sec. Sec. 410.59 and 410.60 with the general supervision
policy that we finalized for RTM services in the CY 2023 PFS final
rule.
(b) General Supervision for PTs and OTs in Private Practice Comment
Solicitation
Sections 1861(p) and 1861(g) (by cross-reference to section
1861(p)) of the Act describe outpatient physical therapy and
occupational therapy services furnished to individuals by physical and
occupational therapists meeting licensing and other standards
prescribed by the Secretary, including conditions relating to the
health and safety of
[[Page 78991]]
individuals who are furnished services on an outpatient basis. The
second sentence of section 1861(p) of the Act describes outpatient
therapy services that are provided to an individual by a physical
therapist or occupational therapist (in their office or in such
individual's home) who meets licensing and other standards prescribed
by the Secretary in regulations and differentiates the therapists that
furnish these outpatient therapy services from those working for an
institutional provider of therapy services. In regulations, we have
specifically addressed these therapists, previously referred to as
PTPPs and OTPPs, since 1999 (63 FR 58868 through 58870). Because we
wanted to create consistent requirements for therapists and therapy
assistants, we clarified in the CY 2005 PFS final rule with comment
period (69 FR 66236, 66351 through 66354) that the personnel
qualifications applicable to home health agencies (HHAs) in 42 CFR part
484 are applicable to all outpatient physical therapy, occupational
therapy, and speech-language pathology services. Also, in the CY 2005
PFS final rule, we cross-referenced the qualifications for OTs and
their OTAs and PTs and their PTAs for all occupational therapy and
physical therapy services, respectively, including those who work in
private practices, to 42 CFR part 484 by adding a basic rule at
Sec. Sec. 410.59(a) and 410.60(a), respectively. Under Medicare Part
B, outpatient therapy services are generally covered when reasonable
and necessary and when provided by PTs and OTs meeting the
qualifications set forth at 42 CFR part 484. Services provided by
qualified therapy assistants, including PTAs and OTAs, may also be
covered by Medicare when furnished under the specified level of
therapist supervision that is required for the setting in which the
services are provided (institutions, and private practice therapist
offices and patient homes).
In accordance with various regulations, the minimum level of
supervision for services performed by PTAs and OTAs by PTs and OTs
working in institutional settings is a general level of supervision
(see Table A in the Report to Congress titled Standards for Supervision
of PTAs and the Effects of Eliminating the Personal PTA Supervision
Requirement on the Financial Caps for Medicare Therapy Services at
https://www.cms.gov/Medicare/Billing/TherapyServices/Downloads/61004ptartc.pdf). For example, 42 CFR 485.713 specifies that when an
OTA or PTA provides services at a location that is off the premises of
a clinic, rehabilitation agency, or public health agency, those
services are supervised by a qualified occupational or physical
therapist who makes an on-site supervisory visit at least once every 30
days. We noted that the Medicare Benefit Policy Manual, Pub. 100-02,
chapter 8, section 30.2.1 defines skilled nursing and/or skilled
rehabilitation services as those services, furnished pursuant to
physician orders, that, among other requirements, ``must be provided
directly by or under the general supervision of these skilled nursing
or skilled rehabilitation personnel to assure the safety of the patient
and to achieve the medically desired result.'' The same manual
provision notes that in the SNF setting, skilled nursing or skilled
rehabilitation personnel include PTs, OTs, and SLPs. However, since
2005 in the private practice setting, we have required direct
supervision for physical and occupational therapy services furnished by
PTAs and OTAs, requiring an OTPP or PTPP to be immediately available to
furnish assistance and direction throughout the performance of the
procedure(s). We finalized this direct supervision policy in the CY
2005 PFS final rule (69 FR 66354 through 66356)--changing it from
personal supervision, which required the OTPP or PTPP to be in the same
room as the therapy assistant when they were providing the therapy
services. Under the current regulations Sec. Sec. 410.59(c)(2) and
410.60(c)(2), all services not performed personally by the OTPP or
PTPP, respectively, must be performed under the direct supervision of
the therapist by employees of the practice. Subsequently, in the CY
2008 PFS final rule (72 FR 66328 through 66332), we updated the
qualification standards at 42 CFR part 484 for OTs, OTAs, PTs, PTAs,
along with those for speech-language pathologists (SLPs).
Over the last several years, interested parties have requested that
we revise our direct supervision policy for PTPPs and OTPPs to align
with the general supervision policy for physical and occupational
therapists working in Medicare institutional providers that provide
therapy services (for example, outpatient hospitals, rehabilitation
agencies, SNFs and CORFs), to allow for the general supervision of
their therapy assistants. Additionally, the interested parties have
informed us that all-but-one State allows for general supervision of
OTAs and at least 44 States allow for the general supervision of PTAs,
via their respective State laws and policies.
We were considering whether to revise the current direct
supervision policy for PTPPs and OTPPs of their PTAs and OTAs, to
general supervision for all physical therapy and occupational therapy
services furnished in these private practices, and solicited comments
from the public that we may consider for possible future rulemaking. We
were particularly interested in receiving comments regarding the
possibility of changing the PTA and OTA supervision policy from direct
supervision to general supervision in the private practice setting, and
whether a general supervision policy could have implications for
situations or conditions raised below:
Because we want to ensure quality of care for therapy
patients, could the general supervision policy raise safety concerns
for therapy patients if the PT or OT is not immediately available to
assist if needed? Do State laws and policies allow a PTA or OTA to
practice without a therapist in a therapy office or in a patient's
home?
Could any safety concerns be addressed by limiting the
types of services permitted under a general supervision policy?
Would a general supervision policy be enhanced with a
periodic visit by the PT or OT to provide services to the patient? If
so, what number of visits or time period should we consider?
Would a general supervision policy potentially cause a
change in utilization? Would such a change in the supervision policy
cause a difference in hiring actions by the PT or OT with respect to
therapy assistants?
Interested parties have been requesting that CMS reconsider its
supervision policies for occupational therapy or physical therapy
services, and in light of experiences during the PHE for COVID-19, we
may consider proposing a general supervision policy for all services
furnished by OTAs and PTAs employed by a PTPP or OTPP in the future
after reviewing the comments and supporting data in response to this
comment solicitation. Therefore, we solicited public comment, along
with supporting data, about the questions and concerns we highlighted
above, for our consideration for possible future rulemaking. We were
further interested in public comment regarding changing Sec. Sec.
410.59(a)(3)(ii), 410.59(c)(2), 410.60(a)(3)(ii), and 410.60(c)(2) to
allow for general supervision of OTAs and PTAs by the OTPP and PTPP,
respectively, when furnishing therapy services. Additionally, we
solicited public comment for our consideration for possible future
rulemaking regarding any appropriate exceptions to allowing general
supervision in the furnishing of therapy services.
[[Page 78992]]
We received public comments on this comment solicitation. The
following is a summary of the comments we received.
Comment: Many commenters stated they supported general supervision
of PTAs and OTAs in the private practice setting, as it would align
with the supervision requirement of all other Medicare therapy settings
and nearly all state practice acts for physical and occupational
therapy. Other commenters stated that making the supervision
requirement consistent across outpatient settings will reduce
administrative burden and confusion and ease compliance for therapy
services providers who work and manage staff in more than one type of
setting.
Collectively, many commenters suggested that changing the Medicare
minimum required supervision level in private practice from direct to
general, for example, would: (a) increase access to therapy services
for more patients, especially those in rural and underserved
communities; (b) allow therapists and therapy assistants to work
different or overlapping schedules to accommodate patient availability;
(c) optimize resource allocation with more flexibility in scheduling
time off for PTs/OTs when PTAs/OTAs are scheduled to work with Medicare
patients; (d) remove the additional labor costs of onsite therapist
staff during delivery of services by therapy assistants, and (e)
eliminate the possibility of disruptions in patient care when the
supervising therapist steps out of the practice office, even for a
short period of time, as the therapy assistant must stop working, the
commenter states that these disruptions can result in patient setbacks,
delayed visits, and greater costs to Medicare.
Many commenters responded to our question as to whether a change to
general supervision would raise safety concerns for therapy patients.
Collectively, commenters did not believe there would be safety concerns
with the change to general supervision; and many commenters also
pointed out that they are unaware of safety concerns arising in the
other Medicare settings where general supervision policies have been in
place for many years, even though acuity levels were suggested by
several commenters to be higher in SNFs and HHAs. Several other
commenters stated that they were not aware of any safety concerns
during the time PTAs/OTAs were treating patients while the PT/OT was
off-site utilizing the direct virtual supervision flexibility through
real-time audio and video technology during the COVID-19 PHE. One
commenter also stated that they believe the existing structure of
guidance from the House of Delegates of the American Physical Therapy
Association, Medicare, and State law authorities on the PT-PTA
relationship is sufficient to ensure patient safety under a general
supervision policy.
Several commenters reported that State licensure practice acts
include supervision policies for all settings, including when PTAs and
OTAs treat patients in therapy offices or in patients' homes. Two
commenters referred us to the Federation of State Boards of Physical
Therapy for a comprehensive list of State supervision laws but listed
out some of the latest trends in states' supervision requirements,
including, for example--44 States require general supervision in all
settings, New York and the District of Columbia are the only
jurisdictions that require on-site supervision of PTAs in all settings,
and five States expressly require a PT to be on-site when a PTA
provides in-home care. These commenters noted that States are
responsibly regulating supervision levels and that where a State has
considered off-site supervision or in-home care as appropriate, CMS
should not require additional standards.
Two commenters stated that Medicare regulations already limit the
types of services permitted to be performed by PTAs and OTAs, for all
settings not just private practice, that is, they may not provide
evaluation services, make clinical judgments or decisions, or take
responsibility for the service. One commenter stated that many States
have added additional restrictions for PTAs and believes that State
licensure and scope of practice requirements for PTAs determine what
services can be safely provided by PTAs to patients, in and off the
premises of each health care setting.
Commenters also noted that Medicare already requires the PT and OT
to ``actively'' treat the patient at least once every 10 treatment
days, per the progress note requirement. In addition, one commenter
stated that many States also mandate that PTs provide periodic
reevaluations or on-site or in-room supervisory visits of PTAs more
frequently than Medicare does. Since Medicare and State laws already
require periodic visits by the PT, one commenter asserted that
additional requirements by CMS are not necessary.
In responding to our question as to whether a general supervision
policy would cause a change in utilization of therapy services,
Commenters mentioned a report by Dobson DaVanzo that they, along with
several other rehabilitation organizations, commissioned to evaluate
the financial impact of various provisions included in the Stabilizing
Medicare Access to Rehabilitation and Therapy (SMART) Act, (H.R. 5536)
in the 117 Congress.\41\ As one issue, the report sought to predict
whether the change to general supervision in the private practice
setting would increase therapy utilization generally and whether a
change in utilization of PTAs/OTAs versus PTs/OTs will occur, as part
of the legislation. Using the report's data, the commenters stated that
by making the supervision policy change--which they indicate replaces
utilization of therapists with therapy assistants--Medicare could save
up to $271.3 million (in 2021 dollars) over a 10-year period from 2022
to 2031. They stated this savings is due to the payment differential,
the 15 percent reduction of the PFS amount--for services furnished in
whole or in part by PTAs and OTAs that went into effect in CY 2022 per
section 1834(v) of the Act.
---------------------------------------------------------------------------
\41\ Dobson DaVanzo & Associates LLC. Impact on Medicare
Spending of the Stabilizing Medicare Access to Rehabilitation and
Therapy Act Assumptions and Methodology Final Technical Report Data,
2022.
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Response: CMS will take these comments into consideration for
possible future rulemaking.
After consideration of public comments in response to our comment
solicitation for general supervision of PTAS and OTAs by PTs and OTs in
private practice, we will take these comments into consideration for
possible future rulemaking.
Additionally, we received public comments on issues that are
considered out-of-scope of the proposals in this rule. As a result, CMS
did not summarize or respond to those comments.
2. KX Modifier Thresholds
Formerly referred to as the therapy cap amounts, the KX modifier
thresholds were established through section 50202 of the Bipartisan
Budget Act (BBA) of 2018 (Pub. L. 115-123, February 9, 2018). These
per-beneficiary amounts under section 1833(g) of the Act (as amended by
section 4541 of the Balanced Budget Act of 1997) (Pub. L. 105-33,
August 5, 1997) are updated each year based on the percentage increase
in the Medicare Economic Index (MEI). In the CY 2023 PFS final rule (87
FR 69688 through 69710), we rebased and revised the MEI to a 2017 base
year. Specifically, these amounts are calculated by updating the
previous year's amount by the percentage increase in the MEI for the
upcoming calendar year and rounding to the nearest $10.00. Thus, for CY
2024, we proposed to increase the CY 2023 KX
[[Page 78993]]
modifier threshold amount by the most recent forecast of the 2017-based
MEI. For CY 2024, the proposed growth rate of the 2017-based MEI is
estimated to be 4.5 percent, based on the IHS Global, Inc. (IGI) first
quarter 2023 forecast with historical data through the fourth quarter
of 2022.\42\ Multiplying the CY 2023 KX modifier threshold amount of
$2,230 by the proposed CY 2024 percentage increase in the MEI of 4.5
percent ($2,230 x 1.045), and rounding to the nearest $10.00 results in
a proposed CY 2024 KX modifier threshold amount of $2,330 for physical
therapy and speech-language pathology services combined and $2,330 for
occupational therapy services. We also proposed that if more recent
data subsequently became available (for example, a more recent estimate
of the CY 2024 2017-based MEI percentage increase), we would use such
data, if appropriate, to determine the final CY 2024 MEI percentage
increase and would apply that more recent MEI percentage increase to
formulate the CY 2024 KX modifier threshold amounts in the CY 2024 PFS
final rule. We received a more recent estimate of the CY 2024 2017-
based MEI percentage increase of 4.6 percent which is greater than the
MEI of 4.5 percent used for determining the proposed $2,330 each for
the CY 2024 KX modifier threshold amounts; however, the MEI of 4.6
percent was not enough to formulate a change to the proposed KX
modifier threshold amounts for CY 2024. Therefore, we are finalizing
the CY 2024 KX modifier threshold amounts of $2,330 for physical
therapy and speech-language pathology services combined and $2,330 for
occupational therapy services as proposed. Section 1833(g)(7)(B) of the
Act describes the targeted medical review (MR) process for services of
physical therapy, speech-language pathology, and occupational therapy
services. The threshold for targeted MR is $3,000 through CY 2027.
Effective beginning with CY 2028, the MR threshold levels would be
annually updated by the percentage increase in the MEI, per section
1833(g)(7)(B) of the Act. Consequently, for CY 2024, the MR threshold
is $3,000 for physical therapy and speech-language pathology services
combined and $3,000 for occupational therapy services. Section
1833(g)(5)(E) of the Act states that CMS shall identify and conduct
targeted medical review using factors that may include the following:
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\42\ IGI is a nationally recognized economic and financial
forecasting firm with which we contract to forecast the components
of the MEI and other CMS market baskets.
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(1) The therapy provider has had a high claims denial percentage
for therapy services under this part or is less compliant with
applicable requirements under this title.
(2) The therapy provider has a pattern of billing for therapy
services under this part that is aberrant compared to peers or
otherwise has questionable billing practices for such services, such as
billing medically unlikely units of services in a day.
(3) The therapy provider is newly enrolled under this title or has
not previously furnished therapy services under this part.
(4) The services are furnished to treat a type of medical
condition.
(5) The therapy provider is part of a group that includes another
therapy provider identified using the factors described previously in
this section.
We track each beneficiary's incurred expenses for therapy services
annually and count them towards the KX modifier and MR thresholds by
applying the PFS rate for each service less any applicable MPPR amount
for services of CMS-designated ``always therapy'' services (see the CY
2011 PFS final rule at 75 FR 73236). We also track therapy services
furnished by critical access hospitals (CAHs), applying the same PFS-
rate accrual process, even though they are not paid for their therapy
services under the PFS and may be paid on a cost basis (effective
January 1, 2014) (see the CY 2014 PFS final rule at 78 FR 74406 through
74410).
When the beneficiary's incurred expenses for the year for
outpatient therapy services exceeds one or both of the KX modifier
thresholds, therapy suppliers and providers use the KX modifier on
claims for subsequent medically necessary services. Through the use of
the KX modifier, the therapist and therapy provider attest that the
services above the KX modifier thresholds are reasonable and necessary
and that documentation of the medical necessity for the services is in
the beneficiary's medical record. Claims for outpatient therapy
services exceeding the KX modifier thresholds without the KX modifier
included are denied. (See the CY 2023 PFS final rule at 87 FR 69650
through 69651))
Comment: One commenter supported the change in the KX modifier
threshold amounts for CY 2024, and thanked us for the confirmation.
Response: We appreciate the supportive remarks from the commenter.
Using the updated MEI of 4.6 in determining the CY 2024 KX modifier
amounts, we are finalizing the CY 2024 KX modifier threshold amounts as
proposed: $2,330 for physical therapy and speech-language pathology
services combined and $2,330 for occupational therapy services.
3. Diabetes Self-Management Training (DSMT) Services Furnished by
Registered Dietitians (RDs) and Nutrition Professionals
During the CY 2022 PFS rulemaking, we adopted a regulation at Sec.
410.72(d) that requires the services that RDs and nutrition
professionals furnish to beneficiaries to be directly performed by
them. This is based on the MNT regulations at subpart G, Sec. Sec.
410.130--410.134. When developing this policy, we were only referring
to MNT services. These MNT services are distinct from the DSMT services
that RDs or nutrition professionals may furnish when they are or
represent an accredited DSMT entity.
We note that the RD or nutrition professional, when named in or a
sponsor of an accredited DSMT entity, may act as the DSMT certified
provider, which is defined at section 1861(qq) of the Act as a
physician or other individual or entity to which Medicare makes payment
for other services. RDs and nutrition professionals may qualify as DSMT
certified providers within the meaning of the statute since they
provide and bill for MNT services. This is reinforced in our sub-
regulatory manual provisions (Pub. 100-02, Chapter 15, section 300.2),
which specifies that DSMT certified providers may bill and be paid for
the entire DSMT program and further clarifies that the RD or nutrition
professional is eligible to bill on behalf of an entire DSMT program
(or entity) on or after January 1, 2002, after obtaining a Medicare
provider number. In addition, section 1861(qq) of the Act requires that
DSMT certified providers meet quality standards established by the
Secretary, except that the physician or other individual or entity
shall be deemed to have met such standards if the physician or other
individual or entity meets applicable standards originally established
by the National Diabetes Advisory Board and subsequently revised by
organizations who participated in the establishment of standards by
such Board. DSMT entities are required to meet the National Standards
for Diabetes Self-management Education Programs (NSDSMEP) set of
quality standards at Sec. 410.144(b). DSMT entities are also required
to be recognized or accredited by CMS Accreditation Organizations
(AOs). There are currently two national DSMT AOs--the American Diabetes
[[Page 78994]]
Association (ADA) or the Association of Diabetes Care & Education
Specialists (ADCES) (Medicare Program Integrity Manual, Pub. 100-08,
chapter 10, section 10.2.4.B). The ADA and ADCES also review and
approve the credentials of DSMT program instructors.
Interested parties have alerted us that the wording of Sec.
410.72(d) has caused confusion for DSMT entities/suppliers and Part B
Medicare Administrative Contractors (MACs) about whether RD or
nutrition professionals must personally provide DSMT services. To
alleviate any confusion, we believe a clarification is needed to
distinguish between when a RD or nutritional professional is personally
providing MNT services, in accordance with the MNT regulations, and
when they are acting as or on behalf of an accredited DSMT entity and
billing for DSMT services that may be provided by a group of other
professionals working under an accredited DSMT entity, for example,
registered nurses (RNs), pharmacists, or RDs other than the sponsoring
RD. Under the NSDSMEP quality standards, the RD, RN, or pharmacist is
permitted to provide the educational DSMT services on a solo basis,
that is without a multi-disciplinary team; however, only the RD or
nutrition professional, when enrolled as a Medicare supplier, in these
accredited DSMT entities is authorized by section 1861(qq)(2)(A) of the
Act to bill Medicare on behalf of the entire DSMT entity as the DSMT
certified provider.
Consequently, we proposed to amend the regulation at Sec.
410.72(d) to clarify that a RD or nutrition professional must
personally perform MNT services. Additionally, we proposed to clarify
that a RD or nutrition professional may bill for, or on behalf of, the
entire DSMT entity as the DSMT certified provider regardless of which
professional furnishes the actual education services. We proposed to
clarify Sec. 410.72(d) to provide that, except for DSMT services
furnished as, or on behalf of, an accredited DSMT entity, registered
dietitians and nutrition professionals can be paid for their
professional MNT services only when the services have been directly
performed by them.
We received public comments on this proposal. The following is a
summary of the comments we received and our responses.
Comment: Many commenters stated their support for the proposal to
clarify and revise Sec. 410.72(d) for the enrolled RD or nutrition
professional, when acting as the DSMT certified provider, may bill for,
or on behalf of, the entire DSMT entity, regardless of which
professional personally delivers each aspect of the services. Some
commenters also supported the proposed regulatory text. One of these
commenters appreciated that the revised text would provide clarity when
Registered Dietitian Nutritionists (RDNs) bill for DSMT services to
make sure they are complying with regulatory guidelines. Although two
commenters recommended that in addition to mentioning RNs and
pharmacists as additional professionals for whom the RD may bill for in
DSMT that we include paraprofessionals in the examples as a means of
aligning our proposal with the accreditation requirements. The
commenters reasoned that ADCES and ADA Accreditation requirements
include the use the paraprofessionals to deliver elements of the DSMT
under the supervision of the RD, noting that many of the trained
professionals have lived experience with diabetes.
Response: We thank the commenters for their comments and
suggestions. We purposely limited the professionals we named in the
proposed clarification of our policy to DSMT team members that the
National Standards quality standards recognizes to provide services
independently, without the supervision of the RD, RN, or pharmacist.
This way, by naming the RD, RN, and pharmacist, it would encompass the
paraprofessionals or other individuals who are being supervised in
accredited ADA or ADCES DSMT entities.
After consideration of public comments, we are finalizing our
proposal to revise Sec. 410.72(d) to clarify that RDs and nutrition
professionals can bill as or on behalf of a DSMT entity regardless of
which professional furnished the actual services, but that they must
directly provide the MNT services they bill for.
4. DSMT Telehealth Issues
(a) Distant Site Practitioners
Since 2006, RDs and nutrition professionals have been recognized as
distant site practitioners for purposes of Medicare telehealth services
under section 1834(m)(4)(E) of the Act. Section 1834(m)(4)(E) of the
Act specifies that the practitioners listed at section 1842(b)(18)(C)
of the Act, which include RDs and nutrition professionals as of 2006,
can serve as distant site practitioners for Medicare telehealth
services. Our regulations and sub-regulatory policies for Medicare
telehealth services do not address scenarios involving the furnishing
of DSMT services via telehealth when the actual services are personally
furnished by individuals who provide them, for example, RNs,
pharmacists, or other multidisciplinary team members, who are not
recognized as telehealth distant site practitioners under the statutory
definition. In keeping with the NSDSMEP quality standards, an RD is
often part of a DSMT entity, and when they are, they can be considered
a ``certified provider'' when they are enrolled in Medicare and intend
to bill for the DSMT services, in accordance with the statutory
provision at section 1861(qq)(2)(A) of the Act, which defines certified
providers as physicians, or other individuals or entities designated by
the Secretary, that, in addition to providing DSMT services, provides
other items or services for which Medicare payment may be made. As we
noted previously in this section of the final rule, there may be other
RDs among the group or team of professionals, along with RNs and/or
pharmacists, that are performing DSMT services in addition to the
sponsoring or billing RD or nutrition professional functioning as the
certified provider. Additionally, our Medicare Benefit Policy Manual,
Pub. 100-02, Chapter 15, section 300.2 clarifies that these certified
providers, including RDs or nutrition professionals, may bill for
services of the DSMT entity. Since we allow RDs and other DSMT
certified providers to bill on behalf of the DSMT entity when other
professionals personally furnish the service in face-to-face
encounters, we believe that this should also be our policy when DSMT is
furnished as a Medicare telehealth service. To increase access to DSMT
telehealth services, we proposed to codify billing rules for DSMT
services furnished as Medicare telehealth services at Sec.
410.78(b)(2)(x) to allow distant site practitioners who can
appropriately report DSMT services furnished in person by the DSMT
entity, such as RDs and nutrition professionals, physicians, nurse
practitioners (NPs), physician assistants (PAs), and clinical nurse
specialists (CNSs), to also report DSMT services furnished via
telehealth by the DSMT entity, including when the services are
performed by others as part of the DSMT entity. This revision to our
regulation will preserve access to DSMT services via telehealth for
Medicare beneficiaries in cases where the DSMT service is provided in
accordance with the NSDSMEP quality standards. We note that DSMT
services are on the Medicare Telehealth Services List, and are subject
to the requirements and conditions of payment under section 1834(m) of
the Act and Sec. 410.78 of our regulations, including originating site
[[Page 78995]]
and geographic location requirements, when they are in effect. See
section II.D. for a discussion of Medicare telehealth policies.
(b) Telehealth Injection Training for Insulin-Dependent Beneficiaries
Currently, our manual instruction for Payment for Diabetes Self-
Management Training (DSMT) in the Medicare Claims Processing Manual,
Pub. 100-04, chapter 12, section 190.3.6, requires 1 hour of the 10-
hour DSMT benefit's initial training and 1 hour of the 2-hour follow-up
annual training to be furnished in-person to allow for effective
injection training when injection training is applicable for insulin-
dependent beneficiaries. This policy was clarified for 2019 to specify
that in-person training only applies to a beneficiary for whom the
injection training was applicable via CMS Transmittal 4173, available
at https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2018Downloads/R4173CP.pdf.
We believe that, with the expansion of the use of telehealth during
the PHE for COVID-19, there have been significant changes in clinical
standards, guidelines, and best practices regarding services furnished
using interactive telecommunications technology, including for
injection training for insulin-dependent patients. We do not want our
policies to prevent injection training via telehealth when clinically
appropriate. Consequently, we proposed to revise our policy at Sec.
410.78(e) to allow the 1 hour of in-person training (for initial and/or
follow-up training), when required for insulin-dependent beneficiaries,
to be provided via telehealth. If finalized, we anticipate revising the
Medicare Claims Processing Manual, Pub. 100-04, chapter 12, section
190.3.6 to reflect that flexibility.
We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: Nearly half of the commenters submitting comments
regarding our proposal for distant site practitioners expressed
concerns about our proposed regulatory text for Sec. 410.78(b)(2)(x)
and the term distant site practitioner, not including outpatient
hospitals, that bill on a UB-04 claim form using their NPI rather than
a personal provider NPI, and pharmacies that enroll as suppliers of
DSMT services. The commenters requested we include the term ``approved
entity'' in the regulatory text and change the term ``report'' to
``bill for.'' Most of these commenters supported modifying the
regulatory text to read as follows: Any distant site practitioner or
approved entity who/that can bill for diabetes self-management training
services may do so on behalf of others who personally furnish the
services as part of the DSMT entity. One commenter stated ADA and ADCES
accreditation data indicates that more than 1,200--or approximately 56
percent--of all accredited DSMT programs, operate out of the outpatient
hospital setting. Similarly, more than 200--or approximately 11
percent--of all accredited DSMT programs are located within pharmacies,
making up two-thirds of all DSMT programs. Five commenters expressed
their support for including services for DSMT and MNT services
furnished remotely by staff in outpatient hospitals to patients in
their homes under section 1834(m) of the Act for payment of telehealth
services see the provision in the Telehealth section at II.D. titled
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.
Another commenter asked that CMS clearly restate that accredited and
recognized DSMT programs are eligible to bill Medicare Part B directly
for DSMT services and may furnish and bill for DSMT services provided
via telehealth, regardless of the provider type (RNs, pharmacists,
registered dietitians, etc.) furnishing the service.
Response: Given that the pharmacy and outpatient hospital are
recognized as certified providers of DSMT services per section 1861(qq)
of the Act, they are recognized to bill for DSMT services they provide
in-person, regardless of which professional furnishes the services. For
purposes of telehealth, though, the current statute is clear at section
1834(m)(4)(E) of the Act, that only physicians and nonphysician
practitioners listed at section 1842(b)(18)(C) of the Act qualify as
distant site practitioners, so that area of Medicare law that does not
include hospitals or pharmacies. However, we agree that the term ``bill
for'' is more appropriate than ``report'' and will modify our proposed
regulation text to reflect this change. We also want to clarify that
CMS did not state that ``accredited and recognized DSMT programs are
eligible to bill Medicare Part B directly for DSMT services and may
furnish and bill for DSMT services provided via telehealth, regardless
of the provider type (RNs, pharmacists, registered dietitians, etc.)
furnishing the service'' since DSMT programs must qualify as a
certified provider in accordance with the statute before they can bill
for DSMT services. However, to the extent that the DSMT program
qualifies as a certified provider of DSMT services and is a distant
site practitioner specified in section 1834(m)(4) of the Act, that
distant site physician or practitioner may bill for DSMT services
furnished via telehealth and may do so on behalf of others who
personally furnish the services as part of the DSMT entity.
Comment: Regarding our proposal on insulin injection-training to
eliminate the regulatory prohibition on providing the full hours of
DSMT via telehealth when clinically appropriate, all commenters were
supportive. Although, a few commenters expressed concern about the
definition of distant site practitioner that does not include all the
DSMT multidisciplinary-team members that furnish injection-training in
addition to RDs, including RNs and pharmacists. These commenters urged
CMS to amend the proposed regulation text so as not to preclude certain
practitioners from providing this important service via telehealth.
Response: We thank the many commenters for their support. Please
refer to the previous response regarding distant site practitioners for
DSMT furnished as Medicare telehealth services.
After consideration of public comments, we are doing the following:
(a) finalizing our proposal on insulin injection-training that will
allow the full initial 10-hours, or annual 2 hours, of DSMT services
for insulin-dependent diabetics, via telehealth, when clinically
appropriate, and we will reflect this change in our Medicare Claims
Processing Manual, chapter 12, section 190.3. 6--Payment for Diabetes
Self-Management Training (DSMT) as a Telehealth Service through our
change management system; and, (b) finalizing our proposed regulatory
text with a modification that replaces the term ``report'' with ``bill
for'' so that the new text for Sec. 410.78(b)(2)(x) will provide that
any distant site practitioner who can appropriately bill for diabetes
self-management training services may do so on behalf of others who
personally furnish the services as part of the DSMT entity.
J. Advancing Access to Behavioral Health Services
1. Implementation of Section 4121(a) of the Consolidated Appropriations
Act, 2023
a. Statutory Amendments
Section 4121(a) of Division FF, Title IV, Subtitle C of the
Consolidated
[[Page 78996]]
Appropriations Act, 2023 (CAA, 2023) (Pub. L. 117-328, December 29,
2022), Coverage of Marriage and Family Therapist Services and Mental
Health Counselor Services under Part B of the Medicare Program,
provides for Medicare coverage of and payment for the services of
mental health care professionals who meet the qualifications for
marriage and family therapists (MFTs) and mental health counselors
(MHCs) when billed by these professionals.
Specifically, section 4121(a)(1) of the CAA, 2023 amended section
1861(s)(2) of the Act by adding a new benefit category under Medicare
Part B in new subparagraph (II) to include marriage and family
therapist services (as defined in an added section 1861(lll)(1) of the
Act) and mental health counselor services (as defined in an added
section 1861(lll)(3) of the Act).
Section 4121(a)(2) of the CAA, 2023 added a new subsection (lll) to
section 1861 of the Act, which defines marriage and family therapist
services, marriage and family therapist (MFT), mental health counselor
services, and mental health counselor (MHC). Section 1861(lll)(1) of
the Act defines ``marriage and family therapist services'' as services
furnished by an MFT for the diagnosis and treatment of mental illnesses
(other than services furnished to an inpatient of a hospital), which
the MFT is legally authorized to perform under State law (or the State
regulatory mechanism provided by State law) of the State in which such
services are furnished, as would otherwise be covered if furnished by a
physician or as an incident to a physician's professional service.
Section 1861(lll)(2) of the Act defines the term MFT to mean an
individual who:
Possesses a master's or doctor's degree which qualifies
for licensure or certification as a MFT pursuant to State law of the
State in which such individual furnishes marriage and family therapist
services;
Is licensed or certified as a MFT by the State in which
such individual furnishes such services;
After obtaining such degree has performed at least 2 years
of clinical supervised experience in marriage and family therapy; and
Meets such other requirements as specified by the
Secretary.
Section 1861(lll)(3) of the Act defines ``mental health counselor
services'' as services furnished by a mental health counselor (MHC) for
the diagnosis and treatment of mental illnesses (other than services
furnished to an inpatient of a hospital), which the MHC is legally
authorized to perform under State law (or the State regulatory
mechanism provided by the State law) of the State in which such
services are furnished, as would otherwise be covered if furnished by a
physician or as incident to a physician's professional service. Section
1861(lll)(4) of the Act defining MHC as an individual who:
Possesses a master's or doctor's degree which qualifies
for licensure or certification as a mental health counselor, clinical
professional counselor, or professional counselor under State law of
the State in which such individual furnishes MHC services;
Is licensed or certified as a mental health counselor,
clinical professional counselor, or professional counselor by the State
in which the services are furnished;
After obtaining such degree has performed at least 2 years
of clinical supervised experience in mental health counseling; and
Meets such other requirements as specified by the
Secretary.
Section 4121(a)(3) of the CAA, 2023 amended section 1833(a)(1) of
the Act to add a new subparagraph (FF), which provides that, with
respect to MFT services and MHC services under section 1861(s)(2)(II)
of the Act, the amounts paid shall be 80 percent of the lesser of the
actual charge for the services or 75 percent of the amount determined
for payment of a psychologist under subparagraph (L).
Section 1888(e)(2)(A)(ii) of the Act, as amended by section
4121(a)(4) of the CAA, 2023, excludes MFT and MHC services from
consolidated billing requirements under the skilled nursing facility
(SNF) prospective payment system. For further discussion about this
exclusion of MFT and MHC services from SNF consolidated billing, see
discussion in the FY 2024 SNF Prospective Payment System (PPS) proposed
rule (88 FR 21316).\43\ Section 4121(a)(5) of the CAA, 2023 amended
section 1842(b)(18)(C) of the Act to add MFTs and MHCs to the list of
practitioners whose services can only be paid by Medicare on an
assignment-related basis. MFTs, MHCs, and other practitioners described
in section 1842(b)(18)(C) of the Act may not bill (or collect any
amount from) the beneficiary or another person for any services for
which Medicare makes payment, except for deductible and coinsurance
amounts applicable under Part B. More information on assignment of
claims can be found in the Medicare Claims Processing Manual, Pub. 100-
04, Chapter 1, Section 30.3.1.
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\43\ https://www.govinfo.gov/content/pkg/FR-2023-04-10/pdf/2023-07137.pdf.
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We also noted that section 1861(aa)(1)(B) of the Act was amended by
section 4121(b)(1) of the CAA, 2023 to add services furnished by MFTs
and MHCs to the definition of rural health clinic services. See section
III.B. of this final rule for discussion related to MFT and MHC
services furnished in RHCs and FQHCs.
Additionally, section 1861(dd)(2)(B)(i)(III) of the Act was amended
by 4121(b)(2) of the CAA, 2023 to require a hospice program to have an
interdisciplinary team that includes at least one social worker, MFT or
MHC. For further discussion about this amended requirement for hospice
program interdisciplinary teams, see section III.O. of this final rule.
b. Proposed Changes to Regulations
Consistent with the changes to the statute described above, we
proposed to create two new regulation sections at Sec. 410.53 and
Sec. 410.54 to codify the coverage provisions for MFTs and MHCs,
respectively.
Specifically, we proposed to define a marriage and family therapist
at Sec. 410.53 as an individual who:
Possesses a master's or doctor's degree which qualifies
for licensure or certification as a marriage and family therapist
pursuant to State law of the State in which such individual furnishes
the services defined as marriage and family therapist services;
After obtaining such degree, has performed at least 2
years or 3,000 hours of post master's degree clinical supervised
experience in marriage and family therapy in an appropriate setting
such as a hospital, SNF, private practice, or clinic; and
Is licensed or certified as a marriage and family
therapist by the State in which the services are performed.
We noted that we are aware that there may be some States that
require a number of hours of clinical supervised experience for MFT
licensure that may be inconsistent with the statutory requirement in
section 1861(s)(2) of the Act that requires at least 2 years of
clinical supervised experience. We believe it could be possible for an
MFT to have completed the required number of clinical supervised hours
required for licensure in their State, but to have accomplished this in
less than two years. Therefore, we proposed a requirement for MFTs to
have performed at least 2 years or 3,000 hours of post master's degree
clinical supervised experience, if consistent with State licensure
requirements. We stated in the proposed rule that we
[[Page 78997]]
believe that 3,000 hours is roughly equivalent to the statutory
requirement to have performed 2 years of clinical supervised experience
and note that the regulatory requirements for clinical social workers
(CSWs) at Sec. 410.73(a)(3)(ii) allow 2 years or 3,000 hours of
supervised experience. Additionally, the statutory benefit category for
both MFTs and CSWs is defined as services for the diagnosis and
treatment of mental illnesses. As such, we believe it would be
appropriate to provide similar flexibility in the required amount of
clinical supervised experience for MFTs and CSWs. We stated in the
proposed rule that we were also interested in public comments regarding
States that have a supervised clinical hour requirement for MFT
licensure that is less than 2 years.
We proposed to define ``Marriage and family therapist services'' at
Sec. 410.53(b)(1) as services furnished by a marriage and family
therapist for the diagnosis and treatment of mental illnesses (other
than services furnished to an inpatient of a hospital), which the
marriage and family therapist is legally authorized to perform under
State law (or the State regulatory mechanism provided by State law) of
the State in which such services are furnished. We also proposed at
Sec. 410.53(b)(1) that the services must be of a type that would be
covered if they were furnished by a physician or as an incident to a
physician's professional service and must meet the requirements of this
section.
Lastly, we proposed at Sec. 410.53(b)(2) that the following
services do not fall under the Medicare Part B benefit category for MFT
services:
Services furnished by a marriage and family therapist to
an inpatient of a Medicare-participating hospital.
Similarly, we proposed to define a mental health counselor at Sec.
410.54 as an individual who:
Possesses a master's or doctor's degree which qualifies
for licensure or certification as a mental health counselor, clinical
professional counselor, or professional counselor under the State law
of the State in which such individual furnishes the services defined as
mental health counselor services;
After obtaining such a degree, has performed at least 2
years or 3,000 hours of post master's degree clinical supervised
experience in mental health counseling in an appropriate setting such
as a hospital, SNF, private practice, or clinic; and
Is licensed or certified as a mental health counselor,
clinical professional counselor, or professional counselor by the State
in which the services are performed. As previously explained for MFTs,
and for the same reasons, we proposed a requirement for MHCs to have
performed at least 2 years or 3,000 hours of post master's degree
clinical supervised experience, if consistent with State licensure
requirements. We believe that 3,000 hours is roughly equivalent to the
statutory requirement to have performed 2 years of clinical supervised
experience and note that the regulatory requirements for clinical
social workers at Sec. 410.73(a)(3)(ii) allows 2 years or 3,000 hours.
The MHC statutory benefit category authorizes MHCs to furnish services
for the diagnosis and treatment of mental illnesses as it does for
CSWs. We stated in the proposed rule that we were also interested in
public comments regarding States that have a supervised clinical hour
requirement for MHC licensure that is less than 2 years.
We proposed to define ``mental health counselor services'' at Sec.
410.54(b)(1) as services furnished by a mental health counselor (as
defined in paragraph (a) of this section) for the diagnosis and
treatment of mental illnesses (other than services furnished to an
inpatient of a hospital), which the mental health counselor is legally
authorized to perform under State law (or the State regulatory
mechanism provided by State law) of the State in which such services
are furnished. We also proposed at Sec. 410.54(b)(1) that the services
must be of a type that would be covered if they were furnished by a
physician or as an incident to a physician's professional service.
We proposed at Sec. 410.54(b)(2) that the following services do
not fall under the Medicare Part B benefit category for MHC services:
Services furnished by a mental health counselor to an
inpatient of a Medicare-participating hospital.
We proposed to amend Sec. 410.10 to add marriage and family
therapist services and mental health counselor services to the list of
included medical and other health services. We also proposed to amend
Sec. 410.150 to add marriage and family therapists and mental health
counselors, to the list of individuals or entities to whom payment is
made.
Currently, Sec. 410.32(a)(2) lists the health care practitioners
that may order diagnostic tests. Since this list currently includes
CSWs and clinical psychologists (CPs), who are also authorized by
statute to furnish services for the diagnosis and treatment of mental
illnesses, we proposed to amend Sec. 410.32(a)(2) to add MFTs and MHCs
to the list of practitioners who may order diagnostic tests, as for the
other non-physician practitioners, to the extent that the MFT or MHC is
legally authorized to perform the service under State law (or the State
regulatory mechanism provided by State law) of the State in which such
services are furnished.
We also proposed to codify in a new Sec. 414.53 the payment
amounts authorized under section 1833(a)(1)(FF) for MFT and MHC
services. Additionally, we proposed to codify at Sec. 414.53 the
payment amount for clinical social worker (CSW) services as authorized
under section 1833(a)(1)(FF) of the Act. As we reviewed our regulations
to implement section 4121 of the CAA, 2023, we found that the payment
amounts for CSWs are not yet codified under regulations. Specifically,
we proposed to add that the payment amount for CSW, MFT, and MHC
services is 80 percent of the lesser of the actual charge for the
services or 75 percent of the amount determined for clinical
psychologist services under the PFS.
We also proposed to add MFTs and MHCs to the list of practitioners
who are eligible to furnish Medicare telehealth services at the distant
site. See section II.D. of this final rule for a discussion of this
proposal.
Additionally, we proposed to allow Addiction Counselors who meet
all of the applicable requirements (possess a master's or doctor's
degree which qualifies for licensure or certification as a mental
health counselor; after obtaining such degree have performed at least 2
years (or, as proposed, 3,000 hours) of clinical supervised experience
in mental health counseling; and licensed or certified as a MHC,
clinical professional counselor, or professional counselor by the State
in which the services are furnished) to enroll in Medicare as MHCs.
That is, under this proposal, Addiction Counselors will be considered
Mental Health Counselors and will be eligible to enroll and bill
Medicare for MHC services if they meet these requirements. We
understand there is variation in the terminology used for licensure
across States for MHCs and MFTs and sought information pertaining to
other types of professionals who may meet the applicable requirements
for enrollment as mental health counselors. We noted that in past
rulemaking, we have discussed the term `mental health' to be inclusive
of diagnosis and treatment of substance use disorders. For example, in
the CY 2022 PFS final rule (86 FR 65061), we stated that SUD services
are considered mental health services for the purposes of the expanded
definition
[[Page 78998]]
of ``interactive telecommunications system.'' We proposed to apply that
same interpretation for purposes of the mental health services included
in the definition of MFT, MHC, and to clarify that the same
interpretation applies for CSW, and CP services.
c. Coding Updates To Allow MFT and MHC Billing
In light of the new statutory benefits for MFTs and MHCs authorized
by section 4121(a) of the CAA, 2023, we have considered whether updates
to certain HCPCS codes are required in order to allow MFTs and MHCs to
bill for the services described by those HCPCS codes. In the CY 2023
PFS final rule, we finalized new coding and payment for General
Behavioral Health Integration services performed by CPs or CSWs to
account for monthly care integration where the mental health services
furnished by a CP or CSW serve as the focal point of care integration.
In light of the new coverage under Medicare for MFT and MHC services
for the diagnosis and treatment of mental illness, we proposed to
revise the code descriptor for HCPCS code G0323 in order to allow MFTs
and MHCs, as well as CPs and CSWs, to be able to bill for this monthly
care integration service. We noted that MFTs and MHCs, like CSWs, are
authorized by statute for the diagnosis and treatment of mental
illnesses (other than services furnished to an inpatient of a
hospital), which the MFT or MHC is legally authorized to perform under
State law (or the State regulatory mechanism provided by State law) of
the State in which such services are furnished, as would otherwise be
covered if furnished by a physician or as an incident to a physician's
professional service. The code descriptor for HCPCS code G0323 is: Care
management services for behavioral health conditions, at least 20
minutes of clinical psychologist, clinical social worker, mental health
counselor, or marriage and family therapist time, per calendar month.
(These services include the following required elements: Initial
assessment or follow-up monitoring, including the use of applicable
validated rating scales; behavioral health care planning in relation to
behavioral/psychiatric health problems, including revision for patients
who are not progressing or whose status changes; facilitating and
coordinating treatment such as psychotherapy, coordination with and/or
referral to physicians and practitioners who are authorized by Medicare
to prescribe medications and furnish E/M services, counseling and/or
psychiatric consultation; and continuity of care with a designated
member of the care team.)
Lastly, we noted that consistent with the changes to valuation of
CPT code 99484 in the Valuation of Specific Codes section (section
II.E. of this final rule), which describes General BHI and is the
crosswalk code used for valuation of HCPCS code G0323, we also proposed
conforming updates to the valuation for work and PE inputs for HCPCS
code G0323. See section II.E. of this final rule for further discussion
of changes to the valuation for HCPCS code G0323.
We welcomed comments regarding any other HCPCS codes that may
require updating to allow MFTs and MHCs to bill for the services
described in the HCPCS code descriptor.
We received many public comments on these proposals to implement
section 4121 of the CAA, 2023. The following is a summary of the
comments we received and our responses.
Comment: Many commenters expressed broad support for our proposals
to implement section 4121 of the CAA, 2023, and expressed appreciation
that CMS is working to expand access to behavioral health services by
allowing for qualified professionals to provide this vital care while
others noted that the increased workforce would help to address
shortages and needs in their communities.
Response: We thank the commenters for their support of our
proposals to implement section 4121 of the CAA, 2023.
Comment: Many commenters expressed support for our proposal to
allow either 2 years or 3,000 hours of clinical supervised experience.
Several commenters provided detailed feedback regarding the amount of
required clinical supervised experience for state licensure for MFTs
and MHCs across States. A few commenters noted a small number of States
that allow for licensure with less than 2 years and fewer than 3,000
hours. They stated that although most licensed and practicing MFTs and
MHCs would meet the clinical supervised experience requirement as
proposed, some would not and noted that those who obtained their
supervised experience in a community mental health setting are more
likely to accumulate the required number of hours of experience in less
than 2 years. The commenters noted that some States differentiate
between direct client contact versus other clinical activities and that
some States require a specified number of direct contact hours. One
commenter encouraged CMS to allow applicants who may not have performed
at least 2 years or 3,000 hours of post master's degree clinical
supervised experience before becoming licensed, but who instead
provided an equivalent number of direct client contact hours to meet
the supervised experience requirements and specified that they believed
that 1,000 hours would be roughly equivalent to the proposed 2 years or
3,000 hours of clinical supervised experience. Other commenters
expressed concern that ambiguity and discrepancies may exist in
implementation across states as some states allow supervised clinical
experience to count toward licensure requirements prior to completing
their degree, and some states do not provide for clinical supervised
experience requirements for licensure, and that licensure requirements
can vary between clinicians with a master's or a doctoral degree. Some
commenters requested that CMS allow for clinical supervised experience
earned post-licensure to count toward the required amount for Medicare
enrollment. A few commenters noted that ``clinical supervised
experience'' was not defined and recommended that CMS be robust in its
consideration of what constitutes such experience. Additionally, some
commenters pointed out that California licensing laws for MFTs and MHCs
consider some supervised clinical experience obtained during the
progression toward academic degrees as supervised experience required
for licensure and noted that while practicing MHCs and MFTs would
generally meet the clinical supervised experience requirement as
proposed, some individuals would not necessarily do so if CMS requires
that all required supervised clinical experience occur following the
granting of the academic degree. Some commenters also expressed that
MFTs and MHCs who have been in practice for an extended period of time
may have difficulty providing documentation of clinical supervised
experience that occurred years or even decades ago. Some commenters
requested that CMS consider accepting an attestation as evidence of
having met the requirement for clinical supervised experience and
others made a similar request for MFTs and MHCs who have not graduated
within the last 5 years.
Response: We note that sections 1861(lll)(2) and1861(lll)(4) of the
Act require that an MFT or MHC, after obtaining such degree has
performed at least 2 years of clinical supervised experience in
marriage and family therapy or mental health counseling. However, we
wish to clarify that clinical
[[Page 78999]]
supervised experience earned after earning the required degree and
licensure can count toward the required amount of clinical supervised
experience for Medicare enrollment purposes. Regarding comments
pertaining to States that differentiate between direct client contact
versus other clinical activities and States that require a specified
number of direct contact hours, we note that a total of 2 years or
3,000 hours of clinical supervised experience is required and we defer
to State law and licensure requirements regarding specifics related to
how many of these hours must be direct client contact. Similarly,
regarding commenters' requests for CMS to define the term ``clinical
supervised experience,'' we did not propose, and are not finalizing a
definition of this term, but rather, defer to State law and licensure
requirements regarding the nature of the 2 years or 3,000 hours of
clinical supervised experience.
We thank the commenters for bringing the issue pertaining to
clinical supervised experience for MFTs or MHCs in certain states,
including California, to our attention. We note that sections
1861(lll)(2) and1861(lll)(4) of the Act require that an MFT or MHC,
after obtaining such degree has performed at least 2 years of clinical
supervised experience in marriage and family therapy or mental health
counseling. As such, any clinical supervised experience would need to
have occurred after obtaining the applicable master's or doctor's
degree which qualifies for licensure or certification as a MFT pursuant
to State law of the State in which such individual furnishes marriage
and family therapist services, or the applicable master's or doctor's
degree which qualifies for licensure or certification as a mental
health counselor, clinical professional counselor, or professional
counselor under State law of the State in which such individual
furnishes MHC services, in order to count toward the required 2 years
or 3,000 hours of clinical supervised experience. However, as noted
above, clinical supervised experience earned after an individual
obtains their licensure can count toward the required amount of
clinical supervised experience for Medicare enrollment purposes.
Lastly, we note that the amount of clinical supervised experience
required to be licensed as an MFT or MHC in certain states is the same
as the required amount of clinical supervised experience that we are
finalizing for Medicare enrollment purposes in this final rule (a total
of 3,000 hours or 2 years). In a situation where an MFT or MHC is
licensed in a state that requires a total of 3,000 hours or 2 years of
clinical supervised experience after the completion of their degree as
a requirement to be licensed as an MFT or MHC, no additional action is
necessary for Medicare enrollment purposes and the Medicare
Administrative Contractor (MAC) will validate the individual's license
and clinical supervised experience during application processing.
Comment: Some commenters expressed concern regarding the statutory
requirement that MFTs and MHCs be paid at 75 percent of the fee
schedule rate and stated that the proposed regulations would prevent
MFTs and MHCs from delivering services to hospital inpatients. A few
commenters suggested that CMS consider add-on codes to more
appropriately value the work, time, and effort of these practitioners,
while others recommended that CMS consider further adjustments to the
valuation of services used to treat mental health and SUDs under the
PFS.
Response: The statutory benefit category for MFTs and MHCs does not
prohibit MFTs and MHCs from delivering services to hospital inpatients.
Rather, payment for MFT and MHC services furnished to hospital
inpatients will be paid under the hospital inpatient prospective
payment system as ``hospital inpatient services,'' consistent with
section 1861(b) of the Act, instead of being paid as ``MFT or MHC
services'' that are paid under the PFS. Additionally, the PFS payment
amounts for MFT services and MHC services at 75 percent of the payment
amount for a clinical psychologist is established in section
1833(a)(1)(FF) of the Act, which provides that, with respect to MFT
services and MHC services under section 1861(s)(2)(II) of the Act, the
amounts paid shall be 80 percent of the lesser of the actual charge for
the services or 75 percent of the amount determined for payment of a
psychologist. We did not consider changing the valuation of services
furnished by MFTs and MHCs in the proposed rule, but we welcome
additional information for our consideration in the future.
Comment: Many commenters expressed support for our proposal to
allow addiction counselors who meet all the applicable requirements of
a MHC to enroll in Medicare as MHCs and bill Medicare for MHC services,
noting that if finalized, this proposal will increase access to needed
care for Medicare beneficiaries with SUDs. Several commenters requested
for CMS to explicitly codify this inclusion at Sec. 410.54 to ensure
that these practitioners and Medicare beneficiaries are aware of this
policy. Several commenters noted that in the Medicaid Managed Care
Access Proposed Rule, when amending its regulations to specify MH and
SUD instead of behavioral health, CMS stated, ``It is important to use
clear, unambiguous terms in regulatory text.'' As such, the commenters
noted they believe it was necessary for CMS to include ``addiction
counselor or alcohol and drug counselor'' at Sec. Sec. 410.54(a)(1)
and (3); ``addiction counseling'' at Sec. 410.54(a)(2); and
``substance use disorders'' at Sec. 410.54(b)(1) in the final rule.
Other commenters similarly recommended that CMS develop new guidelines
(both regulatory and subregulatory) that use the phrase ``mental
health'' or ``addiction'' services, rather than the more global
``behavioral health,'' noting that this is especially important for
States in which addiction counselors and mental health counselors have
distinct roles.
Response: We are finalizing our proposal to allow addiction
counselors who meet all the applicable requirements of a MHC to enroll
in Medicare as MHCs and bill Medicare for MHC services. We understand
that some States certify addiction counselors with a Bachelor's degree;
however, these individuals would not meet the education requirements
for MHCs in the Medicare context. For Medicare purposes, an individual
must possess a master's or doctor's degree to meet the definition of an
MHC as defined at section 1861(lll)(4)(A) of the Act and Sec. 410.54,
which we are finalizing in this rule. While we are not finalizing
changes to the regulation text at Sec. 410.54 to refence addiction
counselors, we note that for Medicare purposes, alcohol and drug
counselors who furnish addiction counseling services for the diagnosis
and treatment of mental illnesses, including substance use disorders,
can enroll in Medicare and bill as MHCs, to the extent that they meet
all of the statutory requirements regarding education, clinical
supervised experience, and licensure. We are finalizing Sec. 410.54 as
proposed, and we refer readers to the discussion in our proposed rule
on this topic (88 FR 52363).
Comment: One commenter noted that the requirements for MFTs and
MHCs are not equivalent to the training that physicians must complete,
noting that physicians complete 4 years of medical school plus 3 to 7
years of residency, including 10,000-16,000 hours of clinical training.
The commenter stated
[[Page 79000]]
that MFTs and MHCs are an essential part of a physician led patient
care team; however, they believe that they lack the requisite medical
education, medication management training, and clinical training that
is critical for the diagnosis and treatment of certain mental
illnesses. As such, though commenters applauded CMS for requiring
adherence to State law, they requested that the definitions of MFTs and
MHCs have a specific additional reference to the requirement that they
must adhere to State scope of practice requirements. The commenter also
stated that the MFT or MHC should be licensed in the State in which the
patient is receiving care, as well as the State in which the
practitioner is located, to ensure that the patient has clear access to
remedies should malpractice occur, especially with the increased use of
telehealth in this space.
Response: We note that for Medicare telehealth services, 42 CFR
410.78(b)(1) requires that the distant site practitioner be ``licensed
to furnish the [telehealth] service under State law.'' Therefore, any
MHCs and MFTs who enroll in Medicare and furnish services would need to
be licensed to furnish the service under State law. Additionally, we
note that sections 1861(lll)(1) and (3) of the Act authorize MFTs and
MHCs to furnish services for the diagnosis and treatment of mental
illnesses which the MFT or MHC is legally authorized to perform under
State law. We require that physicians and any practitioner who
furnishes services under the Medicare program does so in accordance
with their scope of practice. Therefore, MFTs and MHCs who furnish
services under the Medicare program will also be required to adhere to
the scope of practice in their respective State.
Comment: Several commenters requested clarification regarding
variation in terminology used across States. Some commenters encouraged
CMS to clarify that practitioners who meet the applicable requirements
but are licensed by their State under a different title can also bill
for these services and be recognized by Medicare for purposes of this
policy. Other commenters recommended that CMS use the term Mental
Health Professional (MHP) instead of Mental Health Counselor to be more
inclusive of the types of professionals who may meet the applicable
requirements for enrollment as a master's level mental health
practitioner. They specifically requested that CMS recognize licensed
psychological practitioners (Kentucky), licensed clinical
psychotherapists (Kansas), licensed psychological associates (Texas),
psychologist-masters (Vermont), and psychologists (West Virginia) as
MHCs, or preferably as MHPs. Other commenters noted that Michigan has a
licensure category for Licensed Professional Counselors (LPCs) and
California uses the credential title Licensed Professional Clinical
Counselor (LPCC) to describe the same or similar practitioner and noted
that recognizing LPCs, LPCCs, and other functionally similar
practitioners as MHCs for purposes of Medicare enrollment would
increase access to these services. Another commenter advocated for
psychologist associates or psychological associates to be included as
mental health counselors. A few commenters expressed concern that the
definitions of an MHC and MFT under the statute could open the door for
master's level behavioral health professionals, who are not
professional counselors, to qualify for Medicare reimbursement ``as
counselors.'' The commenters stated that while they understand that it
is not within CMS' authority to influence State occupational licensure
requirements and the agency is beholden to the statute as passed by
Congress, they are concerned with a growing trend of non-professional
counselors, such as ``masters level psychologists,'' being granted the
privilege to practice as counselors in some States.
Response: We note that while section 1861(lll)(4) of the Act uses
the term ``mental health counselor,'' the statute defines this term as
a clinical professional counselor or a professional counselor. Section
1861(lll)(4)(A) of the Act defines the term mental health counselor as
an individual who possesses a master's or doctor's degree which
qualifies for licensure or certification as a mental health counselor,
clinical professional counselor, or professional counselor under the
State law of the State in which such individual furnishes MHC services.
Additionally, we proposed that addiction counselors who meet all
applicable requirements for MHCs could enroll in Medicare as MHCs. In
response to the comments received on the variation in nomenclature used
across States for mental health counselors, we wish to make clear that
individuals who meet all of the applicable statutory and regulatory
qualifications for the mental health counselor benefit category for
education and clinical supervised experience, but are licensed or
certified by their State under a different title to furnish mental
health counseling, are eligible to enroll in Medicare under the Part B
``mental health counselor'' statutory benefit category.
Comment: Commenters expressed support for our proposal to revise
the code descriptor for HCPCS code G0323 to allow MFTs and MHCs, as
well as CPs and CSWs, to be able to bill for this monthly care
integration service.
Response: We are finalizing our proposal to update the code
descriptor for HCPCS code G0323, as proposed. The updated code
descriptor for HCPCS code G0323 is: Care management services for
behavioral health conditions, at least 20 minutes of clinical
psychologist, clinical social worker, mental health counselor, or
marriage and family therapist time, per calendar month. (These services
include the following required elements: Initial assessment or follow-
up monitoring, including the use of applicable validated rating scales;
behavioral health care planning in relation to behavioral/psychiatric
health problems, including revision for patients who are not
progressing or whose status changes; facilitating and coordinating
treatment such as psychotherapy, coordination with and/or referral to
physicians and practitioners who are authorized by Medicare to
prescribe medications and furnish E/M services, counseling and/or
psychiatric consultation; and continuity of care with a designated
member of the care team.)
Comment: One commenter urged CMS to update the code descriptors for
all other HCPCS codes that are utilized by current Medicare behavioral
health practitioners and requested that MFTs and MHCs be allowed to
bill for services described in HCPCS code G0409 (Social work and
psychological services, directly relating to and/or furthering the
patient's rehabilitation goals, each 15 minutes, face-to-face;
individual (services provided by a CORF-qualified social worker or
psychologist in a CORF) pertaining to services directly relating to
and/or furthering a patient's rehabilitation goals. The commenter also
encouraged CMS to ensure that MFTs and MHCs are able to provide
services and bill for them using applicable HCPCS codes even if the
code descriptors do not address the provider types eligible to bill for
these services, such as the two new G-codes for psychotherapy for
crisis services, GPFC1 and GPFC2.
Response: As to MFTs and MHCs providing services and billing for
them using applicable HCPCS codes even if the code descriptors do not
address the provider types eligible to bill for these services, we note
that most HCPCS codes do not specify in the code descriptor which
practitioners may
[[Page 79001]]
furnish the service described, so CMS need not change code descriptors
for most codes describing services for the diagnosis and treatment of
mental illnesses in order for MFTs and MHCs to bill for them. As
specified in sections 1861(lll)(1) and (3) of the Act, MFT services and
MHC services include any services that are furnished by the MFT or MHC
for the diagnosis and treatment of mental illnesses, that they are
legally authorized to furnish under State law. Regarding the comment
about HCPCS code G0409, which describes services provided by a CORF-
qualified social worker or psychologist in a CORF, we thank the
commenters for bringing this to our attention and note that this is
something we may take into consideration for future rulemaking.
Comment: Several commenters urged CMS to use its authority to
develop additional codes for substance use counseling that could be
delivered by addiction counselors in office-based and community
settings, similar to the services developed for community health
workers, patient navigators, and peer support specialists in the
proposed rule, and the services identified in the opioid treatment
program regulations. A few commenters also suggested coding for
psychoeducation activities for patients with SUD. Some commenters also
urged CMS to work with Congress to authorize Medicare to cover
addiction counselors who do not have master's degrees but have the
appropriate training and supervision to deliver reasonable and
necessary substance use disorder counseling services to Medicare
beneficiaries. The commenters noted that allowing these additional
substance use disorder counselors to serve Medicare beneficiaries, as
many already do for Medicaid enrollees, aligns with CMS's objective to
expand the workforce capacity to improve access to substance use
disorder prevention, treatment, and recovery services, as outlined in
its Behavioral Health Strategy.
Response: We thank the commenters for this feedback and the
detailed suggestions about potential coding for substance use
counseling and psychoeducation activities. We may consider this for
future rulemaking. We thank the commenters for information regarding
other types of professionals who furnish services for the treatment of
SUDs, but who do not have a master's degree. We will keep this in mind
as we consider ways to improve access to SUD treatment in the future.
We note that the Medicare statute specifies the types of health care
professionals that can enroll and bill the program directly for their
services, and the services of the various recognized health care
professionals are also defined in the statute. However, if a health
care professional does not meet the statutory and regulatory
requirements to enroll in Medicare, and bill and receive Medicare
payment directly, they can instead explore whether they may work with a
physician or other practitioner who is enrolled in the Medicare program
to provide services incident to the billing practitioner's professional
services in accordance with our regulation at Sec. 410.26. This is a
way in which individuals who do not meet the requirements to enroll in
Medicare as MFTs or MHC, for example, addiction counselors and other
professionals who do not have a master's or doctor's degree, may be
able to participate in care furnished to Medicare beneficiaries.
Comment: Several commenters requested that CMS amend the
regulations at 42 CFR 419.22 to add the services of MFTs and MHCs to
the list of Medicare Part B services that are not paid for under the
Hospital Outpatient Prospective Payment System (OPPS) (except when
packaged as part of a bundled payment) in order to clarify that MHC and
MFT services are excluded from payment under the OPPS. The commenters
stated that the regulation at Sec. 419.22 lists those services that
are authorized by Medicare statute to be paid under other payment
systems outside of the OPPS, such as the PFS, the Skilled Nursing
Facility Prospective Payment System (SNF PPS) and, the End-Stage Renal
Disease (ESRD) composite rate.
Response: We thank the commenters for bringing this to our
attention. We proposed a number of changes to our regulations (88 FR
52361 through 52364) to implement the amendments made by section 4121
of CAA, 2023. Generally, these amendments added MFTs and MHCs as types
of non-physician practitioners who can enroll in Medicare and bill
independently for their professional services to diagnose and treat
mental illnesses, and specified that payment is made for these services
at 80 percent of the lesser of the actual charges for the services or
75 percent of the amount determined under the PFS for services of a
clinical psychologist (CP). In proposing to implement section 4121 of
CAA, 2023, we inadvertently did not address whether MFT and MHC
services are excluded from payment under the hospital OPPS. Services
paid under fee schedules or other payment systems, including the
professional services of physicians and nonphysician practitioners, are
not paid under the OPPS (see 69 FR 65685). The regulation at Sec.
419.22 lists the hospital services excluded from payment under the
OPPS, and includes among them the services of qualified psychologists,
as defined in section 1861(ii) of the Act. Because MHC and MFT services
are professional services of nonphysician practitioners for which
payment is made under the PFS at 75 percent of the amount of payment
for services of a psychologist, we believe that in implementing the
amendments to the Act made by section 4121 of the CAA, 2023, we must
also exclude these services from payment under the OPPS, effective
January 1, 2024. Accordingly, we anticipate amending the regulation at
Sec. 419.22 to add the services of MFTs as defined in section
1861(lll)(1) of the Act and the services of MHCs as defined in section
1861(lll)(3) of the Act to the list of hospital services excluded from
payment under the OPPS, at new paragraphs (w) and (x), respectively.
These amendments to the regulation text will be addressed in the CY
2024 OPPS final rule which is expected to be issued on or around the
same time as this final rule.
Comment: A few commenters requested that CMS update the definition
of ``practitioner'' in the regulation text to enable MFTs and MHCs to
opt out of the Medicare program and make use of private contracts with
Medicare beneficiaries.
Response: We thank the commenter for bringing this to our
attention. As noted above, we proposed a number of changes to our
regulations (88 FR 52361 through 52364) to implement the amendments
made by section 4121 of CAA, 2023. Generally, these amendments added
MFTs and MHCs as types of non-physician practitioners who can enroll in
Medicare and bill independently for their professional services to
diagnose and treat mental illnesses, and specified that payment is made
for these services at 80 percent of the lesser of the actual charges
for the services or 75 percent of the amount determined under the PFS
for services of a clinical psychologist (CP). In proposing to implement
section 4121 of CAA, 2023, we inadvertently did not address the section
of the regulation text pertaining to opting out of the Medicare
program. We believe that in implementing the amendments to the Act made
by section 4121 of the CAA, 2023, we must make a conforming change to
Sec. 405.400, which defines ``practitioner'' for opt-out purposes, to
include MFTs and MHCs in the definition of ``practitioner,'' consistent
with other practitioners listed in the regulation text who as
authorized to furnish services for the diagnosis and
[[Page 79002]]
treatment of mental illnesses, such as clinical psychologists and
clinical social workers. Accordingly, we are amending the regulation at
Sec. 405.400 to revise the definition of ``practitioner'' to include a
marriage and family therapist and mental health counselor.
Comment: A few commenters requested that Sec. 410.27, which
permits certain hospital services to be furnished incident to a
physician or nonphysician practitioner's service, be updated to expand
the definition of ``nonphysician practitioner'' to include MFTs and
MHCs.
Response: We thank the commenters for bringing this to our
attention. As noted above, we proposed a number of changes to our
regulations (88 FR 52361 through 52364) to implement the amendments
made by section 4121 of CAA, 2023. Generally, these amendments added
MFTs and MHCs as types of non-physician practitioners who can enroll in
Medicare and bill independently for their professional services to
diagnose and treat mental illnesses, and specified that payment is made
for these services at 80 percent of the lesser of the actual charges
for the services or 75 percent of the amount determined under the PFS
for services of a clinical psychologist (CP). In proposing to implement
section 4121 of CAA, 2023, we inadvertently did not address the section
of the regulation text pertaining to therapeutic outpatient hospital or
CAH services and supplies incident to a physician's or nonphysician
practitioner's service. We believe that in implementing the amendments
to the Act made by section 4121 of the CAA, 2023, we must make a
conforming change to Sec. 410.27 to recognize MFTs and MHCs as a type
of nonphysician practitioner. Accordingly, we are amending the
regulation at Sec. 410.27 to revise the definition of ``nonphysician
practitioner'' to include MFTs and MHCs. This amendment to the
regulation text at Sec. 410.27 will be addressed in the CY 2024 OPPS
final rule.
Comment: A few commenters stated that the regulatory exception to
the physician self-referral law for assistance to compensate a
nonphysician practitioner at Sec. 411.357(x), defines ``nonphysician
practitioner'' at Sec. 411.357(x)(3) to include certain types of
mental health practitioners, but the definition does not include
marriage and family therapists or mental health counselors. The
commenter asked that CMS expand the definition of ``non-physician
practitioners'' to include marriage and family therapists and mental
health counselors, which would permit a hospital to provide assistance
to a physician to compensate such practitioners.
Response: The proposed rule focused on implementing the new benefit
category for MFT and MHC services that permits them to enroll and bill
independently under the Medicare program. The proposed rule addressed
certain enrollment, billing and payment policies for MFTs and MHCs and
the services they furnish, but did not address physician self-referral
policies. We did not propose any changes to Sec. 411.357(x) or any
other physician self-referral regulation in the proposed rule. The
change the commenter suggested falls outside the scope of the proposed
rule. We thank the commenter for bringing this point to our attention
and will take it into consideration for possible future rulemaking.
Comment: We received other comments that were outside the scope of
the proposed rule.
Response: While we are not responding to comments that were outside
the scope of the proposed rule in this final rule, we will take them
into consideration for possible future rulemaking.
After consideration of the public comments, we are finalizing our
proposals to implement section 4121 of the CAA, with some
clarifications and modifications, as described above. In this final
rule, we are clarifying that to the extent that addiction counselors
and alcohol and drug counselors who furnish services for the diagnosis
and treatment of mental illnesses, including substance use disorders,
can meet all of the statutory and regulatory requirements regarding
education, clinical supervised experience, and State licensure for
MHCs, such counselors can enroll in Medicare as MHCs. We are also
finalizing a clarification that individuals who meet the statutory and
regulatory requirements for education and clinical supervised
experience for MHCs, but are licensed to furnish mental health
counseling in their State under a title other than mental health
counselor, clinical professional counselor, or professional counselor,
are eligible to enroll in Medicare as MHCs. We are also finalizing an
amendment to Sec. 405.400 to include MFTs and MHCs as practitioners
who may opt out of Medicare; and will address amendments to Sec. Sec.
419.22 and 410.27 in the CY 2024 OPPS final rule. We believe these
policies to implement section 4121 of the CAA, 2023 will advance health
equity by providing increased access to behavioral health services for
Medicare beneficiaries.
d. Medicare Enrollment of MFTs and MHCs
Individuals who meet the applicable requirements as described in
detail above in this section, and as finalized in this rule, will need
to enroll in Medicare as MFTs and MHCs in order to submit claims for
MFT services or MHC services, respectively, furnished to Medicare
beneficiaries. Under Sec. 424.510, a provider or supplier must
complete, sign, and submit to the relevant MAC the appropriate Form
CMS-855 (OMB Control No. 0938-0685) application in order to enroll in
the Medicare program and obtain Medicare billing privileges. The Form
CMS-855, which can be submitted via paper or electronically through the
internet-based Provider Enrollment, Chain, and Ownership System (PECOS)
process (SORN: 09-70-0532; 104 Provider Enrollment, Chain, and
Ownership System), captures information about the provider or supplier
that is needed for CMS or its MACs to determine whether the provider or
supplier meets all Medicare requirements. We proposed, and are
finalizing, that the MFT and MHC supplier types, like most nonphysician
practitioner types, be subject to limited-risk screening under Sec.
424.518.
Individuals who meet the MFT or MHC requirements in Sec. Sec.
410.53 and 410.54 as finalized, would enroll in Medicare via the Form
CMS-855I application (Medicare Enrollment Application--Physicians and
Non-Physician Practitioners; OMB No. 0938-1355) and could begin
submitting their enrollment applications after the publication of the
CY 2024 PFS final rule. However, as the new benefit categories
authorized by section 4121(a) of the CAA, 2023, do not take effect
until January 1, 2024, MFT or MHC claims for MFT or MHC services
furnished to Medicare beneficiaries with dates of service prior to
January 1, 2024, will not be payable under Medicare Part B. MFTs and
MHCs can visit https://www.cms.gov/medicare/provider-enrollment-and-certification for basic information on the provider enrollment process.
2. Implementation of Section 4123 of the CAA, 2023
Section 4123(a)(1) of the CAA, 2023, Improving Mobile Crisis Care
in Medicare, amended section 1848 of the Act by adding a new paragraph
(b)(12) regarding payment for psychotherapy for crisis services
furnished in an applicable site of service. New subparagraph (A) of
section 1848(b)(12) of the Act requires the Secretary to
[[Page 79003]]
establish new HCPCS codes under the PFS for services described in
subparagraph (B) that are furnished on or after January 1, 2024.
Subparagraph (B) of section 1848(b)(12) of the Act describes these
services as psychotherapy for crisis services that are furnished in an
applicable site of service. Section 1848(b)(12)(C) of the Act specifies
that the payment amount for these psychotherapy for crisis services
shall be equal to 150 percent of the fee schedule amount for non-
facility sites of service for each year for the services identified (as
of January 1, 2022) by HCPCS codes 90839 (Psychotherapy for crisis;
first 60 minutes) and 90840 (Psychotherapy for crisis; each additional
30 minutes (List separately in addition to code for primary service)),
and any succeeding codes.
For purposes of this provision, subparagraph (D)(i) of new section
1848(b)(12) of the Act defines an applicable site of service as a site
of service other than a site where the facility rate under the PFS
applies and other than an office setting, while subparagraph (D)(ii)
requires that the code descriptors for these new psychotherapy for
crisis services be the same as the services identified (as of January
1, 2022) by HCPCS codes 90838 and 90840, and any succeeding codes,
except that the new codes shall be limited to services furnished in an
applicable site of service.
Therefore, consistent with the requirements described in new
paragraph (12) of section 1848(b) of the Act, we proposed to create two
new G-codes describing psychotherapy for crisis services furnished in
any place of service at which the non-facility rate for psychotherapy
for crisis services applies, other than the office setting: HCPCS codes
GPFC1 and GPFC2.
To identify the places of service that are assigned the non-
facility rate, Sec. 414.22(b)(5)(i) states that there are usually two
levels of PE RVUs that correspond to each code paid under the PFS:
facility PE RVUs and non-facility PE RVUs. Under Sec.
414.22(b)(5)(i)(A), the facility PE RVUs apply to services furnished in
a hospital, skilled nursing facility, community mental health center,
hospice, ambulatory surgical center, or wholly owned or wholly operated
entity providing preadmission services under Sec. 412.2(c)(5), or for
services furnished via telehealth under Sec. 410.78 (though we note
that special rules relating to the PHE for COVID-19 currently apply,
and we include proposals regarding the place of service for telehealth
services in section II.D. of this final rule). Under Sec.
414.22(b)(5)(i)(B), the non-facility rate is paid in all other
settings, including a physician's office, the patient's home, a nursing
facility, or a comprehensive outpatient rehabilitation facility. We
provided the full list of places of service that are assigned a non-
facility rate on the CMS website at https://www.cms.gov/Medicare/Coding/place-of-service-codes. We proposed that the two new G-codes
describing psychotherapy for crisis services can be billed when the
services are furnished in any non-facility place of service other than
the physician's office setting. We also noted that in the CY 2022 PFS
final rule (86 FR 65059), in our discussion of Medicare telehealth
services where the patient's home is a permissible originating site for
services furnished for diagnosis, evaluation, or treatment of a mental
health disorder, we indicated that we define the term ``home'' broadly
to include temporary lodging, such as hotels and homeless shelters (86
FR 65059). We clarified that, for circumstances where the patient, for
privacy or other personal reasons, chooses to travel a short distance
from the exact home location during a telehealth service, that would
qualify as the patient's home. For purposes of implementing section
1848(b)(12) of the Act, we proposed to use the same broad definition of
the patient's home for purposes of these proposed G-codes describing
psychotherapy for crisis services.
The new G-codes and their descriptors are:
GPFC1 (Psychotherapy for crisis furnished in an applicable
site of service (any place of service at which the non-facility rate
for psychotherapy for crisis services applies, other than the office
setting); first 60 minutes); and
GPFC2 (Psychotherapy for crisis furnished in an applicable
site of service (any place of service at which the non-facility rate
for psychotherapy for crisis services applies, other than the office
setting); each additional 30 minutes (List separately in addition to
code for primary service)).
As required by section 1848(b)(12)(C) of the Act, we proposed to
establish a fee schedule amount for these two new G-codes that is 150
percent of the current PFS non-facility RVUs for CPT codes 90839
(Psychotherapy for crisis; first 60 minutes) and 90840 (Psychotherapy
for crisis; each additional 30 minutes (List separately in addition to
code for primary service)), respectively. Specifically, we proposed to
calculate the work, PE, and MP RVUs for HCPCS codes GPFC1 and GPFC2 by
multiplying the work, PE, and MP RVUs for CPT codes 90839 and 90840,
respectively, by 1.5.
We noted that section 4123(a)(2) of the CAA, 2023 amends section
1848(c)(2)(B)(iv) of the Act to include a waiver of budget neutrality
providing that paragraph (b)(12) shall not be taken into account in
applying PFS budget neutrality requirements under section
1848(c)(2)(B)(ii)(II) of the Act for 2024. Accordingly, we proposed to
exclude expected expenditures for HCPCS codes GPFC1 and GPFC2 from the
budget neutrality calculation for CY 2024 PFS ratesetting.
Additionally, section 4123(d) of the CAA, 2023 requires that the
Secretary use existing communication mechanisms to provide education
and outreach to providers of services, physicians, and practitioners
with respect to the ability of auxiliary personnel, including peer
support specialists, to participate, consistent with applicable
requirements for auxiliary personnel, in the furnishing of
psychotherapy for crisis services billed under the PFS under section
1848 of the Act, behavioral health integration services, as well as
other services that can be furnished to a Medicare beneficiary
experiencing a mental or behavioral crisis. We understand that there
are varying definitions of the term ``peer support specialist.'' The
Substance Abuse and Mental Health Services Administration (SAMHSA)
defines a ``peer support specialist'' as a person who uses their lived
experience of recovery from mental illness and/or addiction, plus
skills learned in formal training, to deliver services to promote
recovery and resiliency. The essential principles of peer support
include shared personal experience and empathy, a focus on individual
strengths, and supporting individuals as they work toward recovery
pursuant to a person-centered plan of care. However, for Medicare
payment purposes, we noted that the term auxiliary personnel is defined
at Sec. 410.26(a)(1) as any individual who is acting under the
supervision of a physician (or other practitioner), regardless of
whether the individual is an employee, leased employee, or independent
contractor of the physician (or other practitioner) or of the same
entity that employs or contracts with the physician (or other
practitioner), has not been excluded from the Medicare, Medicaid, and
all other Federally funded health care programs by the Office of
Inspector General or had his or her Medicare enrollment revoked, and
meets any applicable requirements to provide incident to services,
including licensure, imposed by the State in
[[Page 79004]]
which the services are being furnished. We do not include definitions
of any specific types of personnel who could be included under the
definition of auxiliary personnel in our regulations and did not
propose to do so in the proposed rule. We anticipate conducting this
outreach and education through existing communications mechanisms as
required by the CAA, 2023.
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 proposals to implement
section 4123 of the CAA, 2023. Some commenters noted that individuals
who are in crisis should be able to access services wherever they are
in need and commended CMS for enabling this flexibility through
proposals included in the proposed rule. Other commenters stated that
in light of the implementation of the 988-crisis system, it is
particularly important to increase access to behavioral health services
that can respond to a crisis in homes and communities and avoid law
enforcement involvement.
Response: We thank the commenters for their support of our
proposals to implement section 4124 of the CAA, 2023.
Comment: We received several comments on the proposal related to
peer support specialists. Many commenters stated that psychotherapy is
not within the scope of practice for peer support specialists. They
stated that peer support specialists do provide engagement services,
including education, support, and sharing lived experience to
facilitate an individual participating in crisis psychotherapy
effectively. The commenters described that peer support specialists are
analogous to emergency medical technicians (EMTs) who are not medical
clinicians but are specially trained to respond in emergency
situations. Other commenters encouraged CMS to provide guidance and
support that meaningfully encourages incorporation of peer support
services, such as by training clinic staff on the value and role of
peer services and ensuring that peer services are utilized in alignment
with state scopes of practice for peers. One commenter requested that
CMS update the regulatory definition of auxiliary personnel to
specifically state that this includes, but is not limited to, peer
support specialists and suggested using language from SAMHSA's national
model standards.
Response: We thank the commenters for highlighting that furnishing
psychotherapy is not within the scope of practice for peer support
specialists. We did not make any proposals specific to peer support
specialists as it pertains to section 4123 of the CAA, 2023. The CAA
requires CMS to provide education and outreach to peer support
specialists, to the extent that they can serve as auxiliary personnel,
regarding psychotherapy for crisis services. Additionally, we wish to
clarify that peer support specialists participating in the furnishing
of any service as auxiliary personnel, including psychotherapy for
crisis, must operate within their scope of the role of peer support
specialists and meet any applicable requirements to provide incident to
services, including licensure, imposed by the State in which the
services are being furnished. We also note that we did not propose to
specify any particular types of personnel in our regulatory definition
of auxiliary personnel; the definition at Sec. 410.26 currently
references ``any individual,'' and we do not believe greater
specificity is warranted at this time.
Comment: A few commenters urged CMS to consider paying for the
existing code billed under Medicaid in many states, HCPCS code H2011
(crisis intervention service per 15 minutes), and to do so at rates
that cover the cost of care, noting that there are limitations to the
psychotherapy for crisis codes in that they require the services be
provided by a licensed practitioner that can bill Medicare
independently. Some of the commenters stated that much of this type of
crisis work is done by a multidisciplinary team that does not always
include someone who can independently bill under the Medicare program.
They stated that the existing coding described by CPT codes 90839 and
90840, and the newly proposed codes which are based on the existing CPT
codes, have the potential to create a barrier to care since they do not
describe or include the resource costs of team-based care. Other
commenters noted that SAMHSA's National Guidelines for Behavioral
Health Crisis include mobile crisis teams as an essential component of
a crisis system and specify that, to fully align with best practice
guidelines, teams must ``incorporate peers within the mobile crisis
team'' and requested that CMS create a pathway for peer support
specialists to be reimbursed when they work with clinicians on mobile
crisis teams. Other commenters recommended CMS create a code for
``Crisis Psychotherapy with engagement services'' and increase the
payment by 40 percent with a modifier to indicate when the service is
furnished by a two-person mobile crisis team. Other commenters
requested adjustments for services furnished in rural areas, as well as
additional payment for mileage, and some suggested that utilizing a
Prospective Payment System (PPS) may be a more appropriate model for
furnishing mobile crisis services. A few commenters requested that CMS
consider whether it would be more appropriate to utilize a methodology
similar to what it uses for establishing EMS/ambulance base rates and
some commenters recommended that CMS consider expanding data collection
and the testing of new payment and service delivery models for EMS
providers to supplement mobile crisis response teams. Other commenters
recommended that CMS create an add-on code for Mobile Crisis Services
to bill up to two additional 30-minute blocks after the first 60
minutes of mobile crisis care, similar to the way HCPCS code 90839
(Psychotherapy for crisis, first hour) can be billed as the primary
code with HCPCS code 90840 (Psychotherapy for crisis, each additional
30 mins). Some commenters noted that after 2 hours of Mobile Crisis
Services, the patient should be transferred to the appropriate level of
care.
Response: We note that the proposals for CY 2024 were specific to
implementing section 4123 of the CAA, which focuses on payment for
psychotherapy for crisis services furnished in an applicable site of
service and specified that the payment amount for these psychotherapy
for crisis services shall be equal to 150 percent of the fee schedule
amount for non-facility sites of service for each year for the services
identified (as of January 1, 2022) by HCPCS codes 90839 (Psychotherapy
for crisis; first 60 minutes) and 90840 (Psychotherapy for crisis; each
additional 30 minutes (List separately in addition to code for primary
service)), and any succeeding codes. However, regarding requests that
CMS consider paying for other types of crisis care that is more
comprehensive or team-based, we agree with commenters regarding the
importance of beneficiary access to crisis services and we may consider
this feedback for future rulemaking. Regarding the comment about an
add-on code, we note that the proposed G codes are based on CPT codes
90839 (Psychotherapy for crisis, first hour) and 90840 (Psychotherapy
for crisis, each additional 30 mins), and therefore, HCPCS codes GPFC1
and GPFC2 do allow for billing an add-on code for each
[[Page 79005]]
additional 30 minutes beyond the first hour.
Comment: A few commenters requested that CMS clarify that
``applicable sites of service'' includes services administered outside
of a clinical setting by a mobile crisis response team, and in a crisis
stabilization unit.
Response: In the CY 2024 PFS proposed rule (88 FR 52364), we
proposed that the two new G-codes describing psychotherapy for crisis
services can be billed when the services are furnished in any non-
facility place of service other than the physician's office setting. We
noted that the full list of places of service that are assigned a non-
facility rate can be found on the CMS website at https://www.cms.gov/Medicare/Coding/place-of-service-codes.
Comment: One commenter requested that we clarify whether a co-pay
would be applicable for these the newly proposed codes and noted that
collecting a co-pay in this context would be difficult unless crisis
psychotherapy is provided to a beneficiary with an existing
professional relationship with the provider(s) furnishing the service.
Response: We note that the Part B coinsurance would apply for the
new psychotherapy for crisis services, as mandated for Part B services
by section 1833(a)(1) of the Act.
After consideration of public comments, we are finalizing our
proposals to implement section 4123 of the CAA, 2023, as proposed.
Specifically, we are finalizing two new G-codes to describe
psychotherapy for crisis furnished in an applicable site of service
(any place of service at which the non-facility rate for psychotherapy
for crisis services applies, other than the office setting) and
establishing a fee schedule amount for these two new G-codes that is
150 percent of the current PFS non-facility RVUs for CPT codes 90839
(Psychotherapy for crisis; first 60 minutes) and 90840 (Psychotherapy
for crisis; each additional 30 minutes (List separately in addition to
code for primary service)), respectively. As required by section
1848(b)(12)(C) of the Act, we proposed, and are finalizing, to
establish a fee schedule amount for these two new G-codes that is 150
percent of the current PFS non-facility RVUs for CPT codes 90839
(Psychotherapy for crisis; first 60 minutes) and 90840 (Psychotherapy
for crisis; each additional 30 minutes (List separately in addition to
code for primary service)), respectively.
We note that the codes GPFC1 and GPFC2 were placeholder codes and
that the final code numbers will be G0017 and G0018. The new G-codes
and their descriptors are:
G0017 (Psychotherapy for crisis furnished in an applicable
site of service (any place of service at which the non-facility rate
for psychotherapy for crisis services applies, other than the office
setting); first 60 minutes); and
G0018 (Psychotherapy for crisis furnished in an applicable
site of service (any place of service at which the non-facility rate
for psychotherapy for crisis services applies, other than the office
setting); each additional 30 minutes (List separately in addition to
code for primary service)).
3. Implementation of Section 4124 of the Consolidated Appropriations
Act, 2023 (CAA, 2023)
Section 4124 of the CAA, 2023, Ensuring Adequate Coverage of
Outpatient Mental Health Services under the Medicare Program,
establishes Medicare coverage and payment for intensive outpatient
services for individuals with mental health needs when furnished by
hospital outpatient departments, community mental health centers, RHCs,
and FQHCs, effective January 1, 2024. Please see the discussion of our
implementation of section 4124 in the CY 2024 Outpatient Prospective
Payment System (OPPS) final rule, section VIII. Payment for Partial
Hospitalization and Intensive Outpatient Services.
4. Health Behavior Assessment and Intervention (HBAI) Services
The current Health and Behavior Assessment and Intervention codes
(CPT codes 96156, 96158, 96159, 96164, 96165, 96167, 96168, 96170, and
96171) were created by the CPT Editorial Panel during its September
2018 meeting. The CPT Editorial Panel deleted the six previous HBAI CPT
codes and replaced them with nine new CPT codes. As discussed in the CY
2023 PFS final rule (87 FR 69541), the HBAI range of CPT codes are
intended to be used for psychological assessment and treatment, when
the primary diagnosis is a medical condition. A health behavior
assessment under these HBAI services is conducted through health-
focused clinical interviews, behavioral observation and clinical
decision-making and includes evaluation of the person's responses to
disease, illness or injury, outlook, coping strategies, motivation, and
adherence to medical treatment. HBAI services are provided
individually, to a group (two or more patients), and/or to the family,
with or without the patient present, and include promotion of
functional improvement, minimization of psychological and/or
psychosocial barriers to recovery, and management of and improved
coping with medical conditions. The HBAI codes apply to services that
address psychological, behavioral, emotional, cognitive, and
interpersonal factors in the treatment/management of people diagnosed
with physical health issues. According to the CPT prefatory language in
the CPT 2023 Professional Edition, the patient's primary diagnosis is
physical in nature and the focus of the assessment and intervention is
on factors complicating medical conditions and treatments. The HBAI
codes capture services related to physical health, such as adherence to
medical treatment, symptom management, health-promoting behaviors,
health related risky behaviors, and adjustment to physical illness.
In light of the new benefit categories authorized by section
4121(a)(2) of the CAA, 2023, which authorize MFTs and MHCs to furnish
services for the diagnosis and treatment of mental illness, this
prompted us to consider whether MFTs and MHCs could furnish and bill
for HBAI services. Additionally, we re-examined whether CSWs could
furnish and bill these HBAI codes given that their statutory benefit
category also authorizes them to furnish services for the diagnosis and
treatment of mental illnesses. We noted that prior to the passage of
the CAA, 2023, which authorized benefit categories for MFTs and MHCs,
there was previously a National Coverage Determination (NCD) that
stated, the CPT codes 96156, 96158, 96159, 96164, 96165, 96167 and
96168 may be used only by a Clinical Psychologist (CP), (Specialty Code
68). However, we noted that this NCD was retired on December 8,
2022.\44\
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\44\ https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleid=57754&ver=12&=.
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Like CPs, who can currently bill Medicare for HBAI services, CSWs,
MFTs, and MHCs have the education and training to address psychosocial
barriers to meet the needs of patients with physical health conditions.
In accordance with State law and scope of practice, CSWs, MFTs, and
MHCs can assess, diagnose, and treat psychological and/or psychosocial
behaviors associated with physical health conditions. Interested
parties have informed us that like CSWs, MHCs and MFTs can play a key
role in a multidisciplinary team approach that leads to successful
outcomes in patient care, including offering integrated care within
hospitals and medical practices where patients are diagnosed with
[[Page 79006]]
physical health conditions. For example, mental health professionals
such as MHCs and MFTs facilitate ``behavioral management and
reinforcement, guided problem-solving, supporting patients in setting
realistic and attainable goals, and teaching relaxation strategies for
managing diabetes-related stressors.'' \45\ In this role, mental health
professionals such as CSWs, MHCs, and MFTs help patients manage mental
health symptoms associated with a physical health condition. Moreover,
according to the National Cancer Institute at the National Institutes
of Health, mental health professionals can also provide emotional and
social support to assist cancer patients in reducing ``levels of
depression, anxiety, and disease and treatment-related symptoms among
patients.'' \46\ Therefore, we proposed to allow the HBAI services
described by CPT codes 96156, 96158, 96159, 96164, 96165, 96167, and
96168, and any successor codes, to be billed by CSWs, MFTs, and MHCs,
in addition to CPs. We noted that in order for payment to be made under
Medicare for HBAI services furnished to a beneficiary, the HBAI
services must be reasonable and necessary for the diagnosis or
treatment of illness or injury or to improve the functioning of a
malformed body member, in accordance with section 1862(a)(1)(A) of the
Act.
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\45\ Powell PW, Hilliard ME, Anderson BJ (2014). Motivational
interviewing to promote adherence behaviors in pediatric type 1
diabetes. Curr Diab Rep. 2014;14(10):531. 10.1007/sll892-014-0531-z.
\46\ National Cancer Institute at the National Institutes of
Health, (nd). ``Stress and Cancer'' https://www.cancer.gov/about-cancer/coping/feelings/stress-fact-sheet.
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We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: All commenters supported our proposal to allow HBAI
services and any successor codes, to be billed by CSWs, MFTs, and MHCs,
in addition to CPs. One commenter requested that we allow HBAI services
to be billed by occupational therapists during the mental health
workforce shortage.
Response: We appreciate the support expressed in the comments. HBAI
services have historically not been designated as therapy services,
therefore occupational therapists cannot furnish these services. As
such, we are not recognizing these codes as therapy services at this
time.
After consideration of public comments, we are finalizing our
proposal to allow the HBAI services described by CPT codes 96156,
96158, 96159, 96164, 96165, 96167, and 96168, and any successor codes,
to be billed by CSWs, MFTs, and MHCs, in addition to CPs.
5. Adjustments to Payment for Timed Behavioral Health Services
There is an ongoing behavioral health crisis in the United States,
which has been exacerbated by the COVID-19 pandemic, the overdose
crisis,\47\ and worsening behavioral healthcare workforce
shortages.\48\ Public comments received in response to the CY 2023 PFS
proposed rule described practices that furnish treatment for behavioral
health conditions experiencing difficulty recruiting and retaining
behavioral health clinicians and expressed concern that people are
experiencing unprecedented delays in receiving medically necessary
services across care settings. Commenters described workforce shortages
nationwide that, combined with increasing demand for behavioral health
care services, have limited Medicare beneficiary access to these vital
services. Prior to the pandemic, the Health Resources and Services
Administration (HRSA) projected shortages of seven selected types of
behavioral health providers by 2025.\49\ As of March 31, 2023, HRSA
designated more than 6,635 health professional shortage areas for
mental health, with more than one-third of Americans living in these
shortage designations.\50\ Additionally, according to SAMHSA's guide on
Addressing Burnout in the Behavioral Health Workforce Through
Organizational Strategies, staffing shortages, and high turnover rates
place enormous demands on the workforce, jeopardizing the provision of
care, especially to underserved individuals.\51\ The behavioral health
workforce experiences high levels of work-related stress, relatively
low salaries, and full caseloads; these combined factors place
individuals working in the behavioral health field at high risk for
experiencing burnout.\52\ Over 50 percent of behavioral health
providers report experiencing burnout symptoms. The rate of burnout
will likely increase, given the continued growth in the number of
people seeking behavioral health care, behavioral health staffing, and
retention challenges.\53\
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\47\ https://www.kff.org/coronavirus-covid-19/issue-brief/the-implications-of-covid-19-for-mental-health-and-substance-use/.
\48\ https://bhw.hrsa.gov/sites/default/files/bureau-health-workforce/data-research/behavioral-health-2013-2025.pdf.
\49\ https://bhw.hrsa.gov/sites/default/files/bureau-health-workforce/data-research/behavioral-health-2013-2025.pdf.
\50\ Health Resources and Services Administration, Health
Workforce Shortage Areas, https://data.hrsa.gov/topics/health-workforce/shortage-areas.
\51\ https://bhw.hrsa.gov/sites/default/files/bureau-health-workforce/data-research/bh-workforce-projections-fact-sheet.pdf.
\52\ Kelly, R.J., Hearld, L.R. Burnout and Leadership Style in
Behavioral Health Care: a Literature Review. J Behav Health Serv Res
47, 581-600 (2020). https://doi.org/10.1007/s11414-019-09679-z.
\53\ https://store.samhsa.gov/sites/default/files/SAMHSA_Digital_Download/pep22-06-02-005.pdf.
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In CY 2023 PFS rulemaking, we sought comment on how we can best
help ensure beneficiary access to behavioral health services, including
any potential adjustments to the PFS ratesetting methodology, for
example, any adjustments to systematically address the impact on
behavioral health services paid under the PFS. We described that as
part of our review of our payment policies and systems, we understand
that the PFS ratesetting methodology and application of budget
neutrality may impact certain services more significantly than others
based on factors such as how frequently codes are revalued and the
ratio of physician work to PE. In the CY 2018 PFS final rule (82 FR
52999), we discussed feedback we received from some interested parties
suggesting that, for codes with very low direct PE inputs, our
methodology for allocating indirect PE does not produce a differential
between facility and nonfacility PE RVUs that accurately reflects the
relative indirect costs involved in furnishing services in non-facility
settings. We stated that primary therapy and counseling services
available to Medicare beneficiaries for the treatment of behavioral
health conditions, including substance use disorders, are among the
services most affected by our methodology. For example, we stated at
the time that, for the most commonly reported psychotherapy service
(CPT code 90834), the difference between the nonfacility and facility
PE RVUs was only 0.02 RVUs, which seemed unlikely to represent the
difference in relative PE resource costs in terms of administrative
labor, office expense, and all other expenses incurred by the billing
practitioner for 45 minutes of psychotherapy services when furnished in
the office setting versus the facility setting. We agreed with these
interested parties that the site of service differential for these
services produced by our PE methodology seems unlikely to reflect the
relative resource costs for the practitioners furnishing these services
in nonfacility settings. For example, we believe the 0.02 RVUs, which
translated at the time to approximately $0.72, was unlikely to
[[Page 79007]]
reflect the relative administrative labor, office rent, and other
overhead involved in furnishing the 45-minute psychotherapy service in
a nonfacility setting. Consequently, we modified our PE methodology to
establish a minimum nonfacility PE RVU for certain outlier codes with
very low direct PE inputs as compared to work RVUs, most of which are
primarily furnished by behavioral health professionals. We finalized a
policy to implement only one quarter of the minimum value for
nonfacility indirect PE for the identified outlier codes over a 4-year
transition period, beginning with CY 2018. We stated that we recognized
that this change in the PE methodology could significantly impact the
allocation of indirect PE RVUs across all PFS services (82 FR 53000).
In light of increasing patient needs for behavioral health services
and continued workforce shortages, we have been examining a number of
dynamics in our processes for developing values for behavioral health
services under the PFS. We continue to consider approaches to ensuring
that the relative values we establish for these services accurately
reflect the resources involved in furnishing them, especially since any
potential systemic undervaluation could serve as an economic deterrent
to furnishing these kinds of services and be a contributing factor to
the workforce shortage.
Interested parties have long raised concerns regarding the
valuation of services that primarily involve person-to-person
interactions with beneficiaries, particularly those services that are
comprised of conversational interactions rather than physical
interactions, because these services require minimal equipment and
supplies compared to other services, and therefore, valuation is based
almost entirely on the practitioner's work. Because the physician/
practitioner work RVU is developed based on the time and intensity of
the service, the issues regarding the valuation of these types of
services are particularly pronounced for services that are billed in
time units (like psychotherapy codes) that directly reflect the
practitioner time inputs used in developing work RVUs, compared to
other services that are not billed in time units in which work RVUs are
based on estimates of typical time, usually based on survey data. For
example, a 2016 report by the Urban Institute entitled Collecting
Empirical Physician Time Data \54\ (the Urban Institute report)
reviewed empirical time estimates for 60 services paid under the PFS
with relative values developed based on time estimates derived from
survey data (as opposed to actual reported time). The Urban Institute
report suggested that there may be systemic overestimations of times
for these services within the PFS, which would lead to overvaluation of
these services and, by implication, undervaluation of other services.
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\54\ https://www.urban.org/sites/default/files/publication/87771/2001123-collecting-empirical-physician-time-data-piloting-approach-for-validating-work-relative-value-units_0.pdf.
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The dynamic described by the Urban Institute report can lead to
systemic undervaluation for some kinds of time-based codes for several,
interrelated reasons. First, overestimates of time for some kinds of
codes compared to other kinds of codes results in ``implied intensity''
(that is the ratio of work RVU/per minute, sometimes referred to by the
AMA RUC as intra-service work per unit of time, or IWPUT) that is
artificially low. This is important since we understand that the
implied intensity is used as part of the AMA RUC review of survey data
to contextualize the credibility of data and the resulting recommended
work RVUs compared to codes with similar times. CMS' review of the RUC
recommendations similarly utilizes implied intensity as important
contextual information in order to assess the relative values assigned
to particular services.
The second reason this dynamic could result in potential
undervaluation of certain services is that time-based codes that
describe one-on-one time with the patient are highly unlikely to become
more efficient over multiple years. In contrast, surgical procedures
tend to become more efficient over the years as they become more
common, professionals gain more experience with them, improved
technology is deployed, and other general operational improvements are
implemented. Meanwhile, 45 minutes of psychotherapy remains static in
terms of efficiency since, by definition, it requires 45 minutes of
time, personally spent by the billing professional, one-on-one with the
patient. Moreover, even if there were efficiencies that reduced the
time required to furnish therapy services, the services would then be
reported with time-based codes with lower total values. Additionally,
in contrast to services such as procedures that utilize clinical staff,
no part of the one-on-one therapy service can be performed by clinical
staff working with the billing professional. This means that any
overestimations in the initial estimates of time used to established
work times and values, as discussed previously, are likely compounded
over time as there are gains in efficiencies for some services in terms
of time, clinical staff delegation, and improved technology, but no
such gains for other services.
For many professionals who provide a heterogenous range of services
paid under the PFS, this phenomenon may not have a significant overall
impact on their Medicare PFS payments. However, this phenomenon would
have an outsized impact on Medicare PFS payments for professionals who
predominantly furnish services involving person-to-person interactions
with patients that are reported and valued in time-based units. It
would not be logical to assume that the marketplace ignores this
dynamic, since the opportunity for increased revenue generation through
efficiency for timed, one-on-one services is limited as compared to
services for which there are multiple avenues to gain efficiencies.
We also recognized that, while this underlying valuation dynamic
may create distortion of increasing magnitude over time, the quickly
changing needs of Medicare beneficiaries relative to behavioral health
also likely contribute to systemic distortion. This is especially the
case as beneficiaries rely on behavioral health professionals for
ongoing care of chronic and acute mental health needs. In other words,
at the same time that the intensity of the work involved in furnishing
services to Medicare beneficiaries increases, the work RVUs assigned to
these services may be initially undervalued relative to other services
that are valued based on potentially inflated time data, and therefore,
may not accurately reflect the current relative resource costs
associated with these services.
One approach to curb the impact of this dynamic would be to conduct
more frequent revaluations of these kinds of services, including timed
psychotherapy services. However, our current valuation process relies
primarily, as noted, on times reported through survey data of
professionals who furnish these services and assessment by the RUC of
those survey data. We believe that survey results from the
professionals that currently provide behavioral health services,
including physicians, psychologists, and social workers could reflect
the increased intensity of the work due to changes in the complexity of
care for beneficiaries, but would be unlikely to address any relative
undervaluation of work estimates. We are interested in working with the
broader community, including the AMA RUC, to address these specific
concerns over the long term.
[[Page 79008]]
However, given the emerging need for access to behavioral health
care and the continuing difficulties in behavioral health workforce
capacity, we believe it would be appropriate to take immediate steps to
improve the accuracy of the valuation of these services until we can
develop systemic solutions to longstanding process limitations.
Consequently, we proposed to address the immediate need for improvement
in valuation for timed psychotherapy services in such a way that
considers the policy we initially finalized in the CY 2020 PFS final
rule (84 FR 62856) in order to address valuation distortions for
primary and longitudinal care through implementation of an add-on code
for office/outpatient E/M services that involve inherent complexity,
and which we proposed to reestablish in this rule. Our implementation
of that policy is discussed in section II.F. of this final rule. Like
E/M visits that are furnished for primary and longitudinal care, we
believe that the psychotherapy codes similarly describe treatment that
is ongoing or longitudinal, and therefore, we believe it is appropriate
to address the need for improvement in valuation for timed
psychotherapy services based on the valuation for the inherent
complexity add-on code for office/outpatient E/M services.
We proposed to apply an adjustment to the work RVUs for the
psychotherapy codes payable under the PFS. We proposed to base this
adjustment on the difference in total work RVUs for office/outpatient
E/M visit codes (CPT codes 99202 through 99205 and 99211 through 99215)
billed with the proposed inherent complexity add-on code (HCPCS code
G2211) compared to the total work RVUs for visits that are not billed
with the inherent complexity add-on code. This resulted in an
approximate upward adjustment of 19.1 percent for work RVUs for these
services, comparable to the relative difference in office/outpatient
visits that are also systemically undervalued absent such an
adjustment, which we proposed to implement over a 4-year transition. In
making significant adjustments to RVUs in past rulemaking, we have
implemented such changes using a 4-year transition, noting that a
transition period allows for a more gradual adjustment for affected
practitioners. We proposed to apply this adjustment to the following
time-based psychotherapy codes that describe one-on-one time with the
patient that are significantly unlikely to become more efficient over
multiple years: CPT code 90832 (Psychotherapy, 30 minutes with
patient); CPT code 90834 (Psychotherapy, 45 minutes with patient); CPT
code 90837 (Psychotherapy, 60 minutes with patient); 90839
(Psychotherapy for crisis; first 60 minutes); CPT code 90840
(Psychotherapy for crisis; each additional 30 minutes (List separately
in addition to code for primary service); CPT code 90845
(Psychoanalysis); 90846 (Family psychotherapy (without the patient
present), 50 minutes); CPT code 90847 (Family psychotherapy (conjoint
psychotherapy) (with patient present), 50 minutes); CPT code 90849
(Multiple-family group psychotherapy); CPT code 90853 (Group
psychotherapy (other than of a multiple-family group) and newly
proposed HCPCS codes GPFC1 and GPFC2 ((Psychotherapy for crisis
furnished in an applicable site of service (any place of service at
which the non-facility rate for psychotherapy for crisis services
applies, other than the office setting). We did not propose to include
CPT codes 90833, 90836, and 90838 in this list of codes for which we
would make the adjustment because these are add-on codes for
psychotherapy that is performed with an E/M visit and under our
proposal described at section II.F. of this final rule, E/M codes will
be eligible to be billed with HCPCS code G2211. Therefore, the
psychotherapy codes that are performed with an E/M visit will already
be eligible for an adjustment to account for the resources costs
involved in furnishing longitudinal care. We stated we believe that
implementing an adjustment to the work RVUs for psychotherapy services
concurrent with implementation of HCPCS code G2211 will help address
distortions that may occur within our valuation process that may
otherwise result in understated estimates of the relative resources
involved in furnishing psychotherapy services. We recognized that many
other services share some similarities with these psychotherapy
services. For example, there are other services that are reported in
time units. Likewise, there are other codes that primarily describe
conversational interactions between medical professionals and
beneficiaries. However, we believe that these services are unique
because neither technology nor clinical staff can be utilized to
increase efficiency, and because these services represent the
significant majority of services furnished by certain types of
professionals. We stated that if finalized, the implementation of this
proposal for CY 2024, concurrent with the proposal to implement the
inherent complexity add-on code, if finalized, would also mitigate any
negative impact in valuation for psychotherapy services based on
redistributive impacts if we were to finalize only the inherent
complexity add-on code for E/M visits without proposing and finalizing
any adjustments for psychotherapy. We welcomed comments on this
proposal, including and especially how the PFS valuation processes for
these services and other services with similar characteristics can be
improved in the future in order to mitigate the kinds of distortions
previously described.
Additionally, as noted above in this section, in the CY 2018 PFS
final rule (82 FR 52999), we identified a set of outlier codes for
which we believed it would be appropriate to establish a minimum
nonfacility indirect PE RVU that would be a better reflection of the
resources involved in furnishing these services. For each of the
outlier codes, we compared the ratio between indirect PE RVUs and work
RVUs that result from the application of the standard methodology to
the ratio for a marker code, which was CPT code 99213. The finalized
change in the methodology then increased the allocation of indirect PE
RVUs to the outlier codes to at least one quarter of the difference
between the two ratios. We stated we believed this approach reflected a
reasonable minimum allocation of indirect PE RVUs, but that we did not
have empirical data that would be useful in establishing a more precise
number. We finalized implementation of one quarter of the minimum value
for nonfacility indirect PE for the identified outlier codes. We stated
that we recognized that this change in the PE methodology could have a
significant impact on the allocation of indirect PE RVUs across all PFS
services and finalized that we would implement this change over a 4-
year transition, beginning in CY 2018 and ending in CY 2021. We
welcomed comments on whether we should consider further adjustments to
the nonfacility indirect PE for the identified outlier codes.
Specifically, we requested comment on whether this minimum value
adjustment to the indirect PE for certain services sufficiently
accounted for the resources involved in furnishing these services, or
whether we should consider further adjustments, such as applying 50
percent of the calculated minimum value for nonfacility indirect PE
values for these services, and whether we should consider implementing
further changes using a similar 4-year transition.
We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
[[Page 79009]]
Comment: Many commenters supported the proposed increase, and
expressed appreciation that CMS recognized the limitations associated
with the valuation of time-based services that must be performed
directly by the clinician that offers no opportunity to become more
efficient over time. Some commenters stated that the proposed changes
will help close the access gap to behavioral health services by
expanding the behavioral health workforce and paying more accurately
for behavioral health services.
Response: We thank the commenters for their support of this
proposal.
Comment: Many commenters requested that CMS also increase the
values for other similar services. Some commenters stated they believe
that the increase should also be applied to the psychotherapy codes
that are billed as an add-on to an E/M visit (CPT codes 90833, 90836,
and 90838), noting that not doing so would further exacerbate the lack
of pay-parity and result in rank order anomalies. The commenters also
stated that if finalized, this policy would have the unintended
consequence of devaluing the work of psychiatrists when compared to
psychologists, social workers, and other mental health professionals,
thereby further discouraging psychiatrist participation in Medicare,
while also reducing access for patients to what has been shown to be
one of the most effective treatments, combined psychotherapy and
medication management. These commenters also referenced our statement
in the CY 2012 PFS rule final rule that, ``. . .we believe that the
work involved in furnishing the psychotherapy add-on CPT codes is very
similar to the work of furnishing the stand-alone psychotherapy CPT
codes'' and that the work itself is the same regardless of the
professional degree held by the clinician, with the same constraints
due to the time-based nature of the codes and the fact that the
clinician, and not their clinical staff, must provide the care. Many
commenters requested that the increase also be applied to the HBAI
services, as well as the psychological and neuropsychological testing
services.
Response: We thank the commenters for this feedback. After
consideration of the comments received, we are finalizing the 19.1
percent increase to the work RVUs for the standalone psychotherapy
codes, transitioned over the course of 4 years, as proposed.
Additionally, we are finalizing to apply the same increase to the work
RVUs for the psychotherapy codes that are billed as an add-on to an E/M
visit (CPT codes 90833, 90836, and 90838), as we agree with the
commenters and our statement in past rulemaking that the work involved
in furnishing the psychotherapy add-on CPT codes is very similar to the
work of furnishing the stand-alone psychotherapy CPT codes, and
therefore, agree that it is appropriate to apply the increase to the
psychotherapy codes billed as an add-on to E/M visit in addition to the
standalone psychotherapy codes. We do not wish to discourage
psychiatrist participation in Medicare and believe that applying this
increase to the work RVUs for all of the psychotherapy codes, whether
billed with an E/M visit or as a standalone service, will avoid the
relativity issues the commenters raised. In addition to finalizing the
increase to the work RVUs for the standalone psychotherapy codes and
the psychotherapy codes that are billed as an add-on to an E/M visit,
we are also finalizing the proposed increase to the work RVUs of the
codes describing HBAI services (CPT codes 96156, 96158, 96159, 96164,
96165, 96167, and 96168), as we believe that these codes are similar to
the psychotherapy services in that these codes are also timed services
and are generally provided person-to-person without support from
clinical staff. Regarding the request to apply the proposed increase to
the work RVUs of the codes describing psychological and
neuropsychological testing services, we believe psychological and
neuropsychological testing services are distinct from psychotherapy and
HBAI services with regard to the nature of the work in that they are
not necessarily timed services that are provided without assistance
from clinical staff, and therefore, do not fit the same criteria as the
services addressed in the proposed rule. We welcome additional feedback
on the valuation of the psychological and neuropsychological testing
services, and we may consider updates to the valuation of these
services in future rulemaking.
Comment: The RUC acknowledged the emerging need for access to
behavioral health care and the continuing difficulties in behavioral
health workforce capacity, but stated they did not believe that a
systematic percentage increase to the psychotherapy services would
appropriately address this issue and would negatively exacerbate the
relativity to other services paid under the PFS. They stated that
distortions and rank order anomalies would result if finalized as
proposed. For example, they noted that if these increases are
implemented for CPT code 90837 (Psychotherapy, 60 minutes with
patient), the fully transitioned work RVU in 2028 will be higher than
the work RVU for CPT code 90838 (Psychotherapy, 60 minutes with patient
when performed with an evaluation and management service), when
reported with a CPT code 99213 office visit.
Response: We welcome RUC review and recommendations on the
valuation for these services, however, we reiterate our concerns
described in the proposed rule that survey results from the
professionals that currently provide behavioral health services,
including physicians, psychologists, and social workers, could reflect
the increased intensity of the work due to changes in the complexity of
care for beneficiaries, but would be unlikely to address any relative
undervaluation of work estimates due to the longstanding systematic
undervaluation of this type of work. Additionally, as noted above, we
are finalizing to apply the 19.1 percent increase to the work RVUs for
the psychotherapy codes that are billed as an add-on to an E/M visit
(CPT codes 90833, 90836, and 90838), transitioned over the course of 4
years, in order to avoid any rank order anomalies within the
psychotherapy code family.
Comment: A few commenters suggested that as an alternative to the
proposed increase, CMS create a separate G-code for psychiatry services
with an RVU equivalent to the RVU for HCPCS code G2211 that could be
used by qualified mental health professionals (that is, psychologists
and social workers) as an add-on to stand-alone psychotherapy, similar
to the way the CPT code 90785 (Interactive Complexity) is used.
Response: While an add-on G-code could serve to address the issues
we cited in the proposed rule, we believe that building the proposed
increase into the valuation of these services would more directly
address the systematic undervaluation of these services. Unlike HCPCS
code G2211 and CPT code 90785, which are meant to be billed only in
certain specified circumstances, we believe that the issues we describe
in the proposed rule apply the psychotherapy services uniformly.
Comment: A few commenters expressed concern that the proposed
increase is insufficient, especially recognizing that many of the
practitioners who bill these codes, including Clinical Social Workers,
and as of January 1, 2024, Marriage and Family Therapists and Mental
Health Counselors, are only reimbursed at 75 percent of the PFS rate.
The commenters recommended that CMS consider
[[Page 79010]]
further adjustments to the ratesetting methodology, pending legislative
change. The commenters noted that a more substantial increase would
further the goal of bringing more mental health and SUD practitioners
into the Medicare program. One commenter recommended that CMS consider
ways to either mitigate the impact of behavioral health payment
increases on other services by spreading budget neutrality adjustment
over longer time horizons, or suggested that Congress should
appropriate additional, permanent funding for behavioral health
services within the PFS.
Response: We will continue to evaluate how we can ensure that these
services are valued accurately, but we believe that the final increase
of 19.1 percent to the work RVUs for psychotherapy services and
psychotherapy codes that are billed as an add-on to an E/M visit (CPT
codes 90833, 90836, and 90838) is sufficient. We based this adjustment
on the valuation for the inherent complexity add-on code that will be
used with office/outpatient E/M services to address valuation
distortions for primary and longitudinal care, and since the
psychotherapy codes similarly describe treatment that is ongoing or
longitudinal, we believe that it is appropriate to address the need for
improvement in valuation for timed psychotherapy services based on the
valuation for the inherent complexity add-on code for office/outpatient
E/M services.
Regarding ways to mitigate the impact of these increases on other
services, we note that we are implementing these changes over a 4-year
transition, as we have done when making significant adjustments to RVUs
in past rulemaking. We believe that this transition period will allow
for a more gradual budget neutrality adjustment for affected
practitioners. Regarding practitioners such as CSWs, MFTs, and MHCs
being paid at 75 percent of the PFS rate for services of a clinical
psychologist, we note that this is a requirement specified in section
1833(a)(1)(FF) of the Act.
Comment: Some commenters supported finalizing the proposal but
recommended that CMS view the adjustment as a temporary stopgap and
consider long-term solutions to code valuation moving forward. Another
commenter urged CMS to implement RVU accuracy assessments annually, or
at least more frequently.
Response: We reiterate that we are interested in working with the
broader community, including the AMA RUC, to address these specific
concerns regarding valuation and RVU accuracy over the long term.
Comment: One commenter stated that the market rate for out-of-
network mental health care far exceeds Medicare rates and suggested
that CMS should conduct a review and issue a report comparing out-of-
network billing rates to Medicare rates and determine if the current
code valuation process reflects the market. The commenter went on to
suggest that accordingly, CMS should make changes to the RUC/RVU system
so it more closely values behavioral healthcare at market rates. The
commenter also noted that CMS should recognize that it has historically
undervalued these rates for decades and it will take time and
incentives to grow the workforce.
Response: We thank the commenter for this feedback. We note that we
are trying to address potential historical undervaluation of certain
mental health services in this rule. We will continue to evaluate how
we can make sure that these services are valued accurately and may
consider these comments regarding market rates for future rulemaking.
After consideration of the public comments, we are finalizing our
proposal to apply an upward adjustment of 19.1 percent to the work RVUs
for the standalone psychotherapy services, in addition to the
psychotherapy codes that are billed as an add-on to an E/M visit (CPT
codes 90833, 90836, and 90838) and the codes describing HBAI services
(CPT codes 96156, 96158, 96159, 96164, 96165, 96167, and 96168), and we
are finalizing our proposal to implement this adjustment over a 4-year
transition.
6. Updates to the Payment Rate for the PFS Substance Use Disorder (SUD)
Bundle (HCPCS Codes G2086-G2088)
In the CY 2023 PFS final rule (87 FR 69772 through 69774), we
finalized a modification to the payment rate for the non-drug component
of the bundled payment for episodes of care under the Opioid Treatment
Program (OTP) benefit to base the rate for individual therapy on a
crosswalk to CPT code 90834 (Psychotherapy, 45 minutes with patient),
which reflects a 45-minute psychotherapy session, instead of a
crosswalk to CPT code 90832 (Psychotherapy, 30 minutes with patient),
as was our current policy at the time. We received public comments
urging us to consider adopting this modification for other bundled
payments for SUD under the PFS, such as the bundled rate for office-
based SUD treatment, to reflect the complexity of treating these
patients and ensure that there is consistent and sufficient access to
counseling for SUD across settings of treatment. The commenters noted
that some patients who are prescribed buprenorphine in non-OTP settings
will have similarly complex care needs requiring more intensive
therapeutic care, and that by recognizing the appropriate complexity
and intensity of the services in setting the rates, CMS can incentivize
more office-based practices to offer these services and build out the
treatment teams that deliver this care.
In the CY 2020 PFS final rule (84 FR 62673 through 62677), we
finalized the establishment of bundled payments for the overall
treatment of OUD, including management, care coordination,
psychotherapy, and counseling activities. We stated that for the
purposes of valuation of HCPCS codes G2086 (Office-based treatment for
a substance use disorder, including development of the treatment plan,
care coordination, individual therapy and group therapy and counseling;
at least 70 minutes in the first calendar month) and G2087 (Office-
based treatment for a substance use disorder, including care
coordination, individual therapy and group therapy and counseling; at
least 60 minutes in a subsequent calendar month), we assumed two
individual psychotherapy sessions per month and four group
psychotherapy sessions per month, and noted that we understand that the
number of therapy and counseling sessions furnished per month will vary
among patients and also fluctuate over time based on the individual
patient's needs. We were persuaded by the public comments received in
response to the CY 2023 PFS proposed rule requesting that these codes
be priced consistent with the crosswalk codes used to value the bundled
payments made for OUD treatment services furnished at OTPs, as
beneficiaries receiving buprenorphine in settings outside of OTPs may
have similarly complex care needs as compared to beneficiaries
receiving OUD treatment services at OTPs. In order to update the
valuation for HCPCS codes G2086 and G2087, we proposed to increase the
current payment rate to reflect two individual psychotherapy sessions
per month, based on a crosswalk to the work RVUs assigned to CPT code
90834 (Psychotherapy, 45 minutes with patient), rather than CPT code
90832 (Psychotherapy, 30 minutes with patient). The current work RVU
assigned to CPT code 90834 is 2.24, compared to the work RVU assigned
to CPT code 90832, which is 1.70, which results in a difference of 0.54
work RVUs. Because the bundled payments
[[Page 79011]]
described by HCPCS codes G2086 and G2087 include two individual
psychotherapy sessions per month, we proposed to add 1.08 RVUs to the
work value assigned to HCPCS codes G2086 and G2087, which results in a
new work RVU of 8.14 for HCPCS code G2086 and 7.97 for HCPCS code
G2087. We noted that as described above, we also proposed to update the
work RVUs assigned to CPT code 90834. We noted in the proposed rule
that if our proposal to update the work RVUs for the standalone
psychotherapy codes were finalized, CPT code 90834 would be assigned a
work RVU of 2.35. We stated that in that case, our update to HCPCS
codes G2086 and G2087 would also reflect the updated work RVUs for
90834 and would result in a work RVU of 8.36 for HCPCS code G2086 and a
work RVU of 8.19 for HCPCS code G2087.
We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: Many commenters expressed support for this proposal.
Commenters stated that they agreed that the proposed increase more
accurately reflects the cost, time, and effort of delivering these
services. Commenters stated that by making the proposed adjustment, CMS
will help to increase access to office-based SUD treatment and meet
beneficiaries where they are and noted that the proposed increased
payment rate will also enable more auxiliary personnel to participate
in interdisciplinary teams, further ensuring that beneficiaries have
the full range of services and supports they need. Some commenters
stated that the proposed payment increase will help ensure that the
complex care needs of patients receiving in-office treatment for SUDs
are addressed and that the complexity of delivering office-based SUD
treatment is accurately reflected.
Other commenters expressed support for actions to facilitate access
to substance use disorder treatment, including medications for Opioid
Use Disorder, like buprenorphine, noting that the U.S. is in the midst
of a drug overdose epidemic and that according to the Centers for
Disease Control and Prevention, 106,699 people died from a drug
overdose in 2021, a 14 percent increase from 2020.\55\ The commenters
described that in-office treatment for SUDs can also enable patients to
receive care for co-occurring conditions.
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\55\ https://www.cdc.gov/drugoverdose/deaths/index.html.
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Response: We thank the commenters for their support of this
proposal. We agree that the proposed increase more accurately reflects
the cost, time, and effort of delivering office-based SUD services. We
aim to ensure that beneficiaries have access to the full range of
services needed, especially in light of the drug overdose epidemic
referenced in the comments. After consideration of the public comments,
we are finalizing as proposed to increase the payment rate for HCPCS
codes G2086 and G2087 to reflect two individual psychotherapy sessions
per month, based on a crosswalk to the work RVUs assigned to CPT code
90834 (Psychotherapy, 45 minutes with patient), rather than CPT code
90832 (Psychotherapy, 30 minutes with patient).
7. Comment Solicitation on Expanding Access to Behavioral Health
Services
In recent years, we have made efforts to undertake rulemaking and
establish policies to expand access to behavioral health services,
consistent with the CMS Behavioral Health Strategy, which aims to
strengthen quality and equity in behavioral health care; improve access
to substance use disorders prevention, treatment, and recovery
services; ensure effective pain treatment and management; improve
mental health care and services; and utilize data for effective actions
and impact.\56\ We continue to be interested in hearing feedback
regarding ways we can continue to expand access to behavioral health
services. For example, we welcomed feedback regarding ways to increase
access to behavioral health integration (BHI) services, including the
psychiatric collaborative care model; whether we could consider new
coding to allow interprofessional consultation to be billed by
practitioners who are authorized by statute for the diagnosis and
treatment of mental illness; intensive outpatient (IOP) services
furnished in settings other than those addressed in the CY 2024 OPPS
proposed rule; and how to increase psychiatrist participation in
Medicare given their low rate of participation relative to other
physician specialties. Additionally, we solicited comment on whether
there is a need for potential separate coding and payment for
interventions initiated or furnished in the emergency department or
other crisis setting for patients with suicidality or at risk of
suicide, such as safety planning interventions and/or telephonic post-
discharge follow-up contacts after an emergency department visit or
crisis encounter, or whether existing payment mechanisms are sufficient
to support furnishing such interventions when indicated.
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\56\ https://www.cms.gov/cms-behavioral-health-strategy.
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We welcomed comments from the public on these topics as well as any
other ways we might consider expanding access to behavioral health
services for Medicare beneficiaries.
We received public comments in response to these comment
solicitations. The following is a summary of the comments we received
and our responses.
Comment: We received many detailed comments on these topics.
Commenters provided feedback regarding potential ways to expand
implementation of the psychiatric collaborative care model (CoCM) and
suggestions to support technical assistance and increased payments for
CoCM.
In response to our comment solicitation regarding whether there is
a need for potential separate coding and payment for interventions
initiated or furnished in the emergency department or other crisis
setting for patients with suicidality or at risk of suicide, such as
safety planning interventions and/or telephonic post-discharge follow-
up contacts after an emergency department visit or crisis encounter,
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. Commenters also
cited that multiple trials have found FCI to reduce improve outcomes
and specifically, to reduce suicide attempts and deaths, but noted that
despite the effectiveness of these interventions, they are
underutilized.
Regarding settings of care where IOP services are furnished,
commenters described that IOP services are most commonly delivered in
freestanding community-based SUD treatment facilities and suggested
that CMS create coding that would enable IOP to be delivered in these
settings.
[[Page 79012]]
Commenters also suggested a variety of ways to improve psychiatrist
participation in Medicare and many cited low and disparate
reimbursement rates as a significant barrier.
Response: We thank the commenters for the many detailed comments
received on these topics and note that we may consider this input for
potential policy proposals through future rulemaking.
8. Request for Information on Digital Therapies, Such as, but not
Limited to, Digital Cognitive Behavioral Therapy
The widespread adoption and use of software technologies,
including, but not limited to digital therapeutics, is creating new
ways to treat patients. In recent years, the Food and Drug
Administration (FDA) has reviewed and cleared several mobile medical
applications (``apps'') that have been shown to demonstrate a
reasonable assurance of safety and effectiveness for addressing a
variety of health conditions including sleep disorders disturbances and
substance use disorders. These breakthrough devices include apps for
depression and anxiety. Our understanding is that these mobile medical
apps generally require a prescription or referral from a clinician and
are used for specific medical purposes rather than general wellness and
education.
As technologies have evolved, we have sought public comment and
expanded Medicare payment under Part B for use of technologies in
remote monitoring of treatment and physical health. Beginning in 2018,
CMS began making separate payment for the services described by CPT
code 99091, which paid for collection and interpretation of physiologic
data digitally stored and/or transmitted to the practitioner. Beginning
in 2019, we began paying for additional new remote physiologic
monitoring (RPM) codes.
We have continued to improve and expand payment for remote
treatment and monitoring in subsequent years. In 2022, we began paying
for a new class of CPT codes (98975, 98980, and 98981) for Remote
Therapeutic Monitoring (RTM) in addition to RPM, which enabled
reimbursement of monitoring of non-physiologic data, to help ensure
Medicare beneficiaries have access to these services. RTM is currently
limited to monitoring respiratory system status, musculoskeletal
status, and therapy adherence, or therapy response (87 FR 69647).
However, we continue to add, clarify, and refine payment for RTM codes.
In the CY 2023 PFS final rule (87 FR 69645), we finalized a new RTM
code for supply of a device for cognitive behavioral therapy monitoring
(CPT Code 989X6 Remote therapeutic monitoring (e.g., therapy adherence,
therapy response); device(s) supply with scheduled (e.g., daily))
recording(s) and/or programmed alert(s) transmission to monitor
cognitive behavior therapy, each 30 days). In that rule, we noted
specialty societies indicated the technologies for this service are
still evolving, and as a result, there were no invoices for devices
specific to the cognitive behavioral therapy monitoring services
described by the code that could be shared. We accepted the RUC
recommendation to contractor price CPT code 989X6, a PE-only device
code. We stated we would work with Medicare Administrative Contractors
(MACs) to better understand the devices and device costs they encounter
as they review claims for payment for the new cognitive behavioral
monitoring code.
For both RPM and RTM codes, the device used must meet the FDA
definition of a device as described in section 201(h) of the Federal
Food, Drug and Cosmetic Act (FFDCA). As we continue to gather
information on how remote monitoring services are used in clinical
practice and experience with coding and payment policies for these
codes, we requested information on the following areas to improve our
understanding of the opportunities and challenges related to our
coverage and payment policies, as well as claims processing, as we
consider the need for further practitioner education, program
instructions, and guidance, or potential future rulemaking regarding
these services.
How do practitioners determine which patients might be
best served by digital therapeutics? How do practitioners monitor the
effectiveness of prescribed interventions, such as, but not limited to,
for their patients on an ongoing basis once the intervention has begun?
We sought comment and real-life examples where digital
cognitive behavioral therapy or other digital enabled therapy services
are used by clinicians, and how the technology is imbedded in various
practice models. For example, how is the patient evaluated and/or how
is the treating clinician involved in the services received when the
patient participates in digital cognitive behavioral therapy?
What standards have interested parties developed or
consulted to ensure the physical safety and privacy of beneficiaries
utilizing digital cognitive behavioral therapy (CBT) and/or other
digital therapeutics for behavioral health?
What are effective models for distribution/delivery of
digital therapeutics, such as prescription digital mental health
therapy products to patients? What best practices exist to ensure that
patients have the necessary support and training to use applications
effectively?
What practitioners and auxiliary staff are involved in
furnishing RPM and RTM services, including training patients on its
use, and to what extent is additional training or supervision of
auxiliary staff necessary to provide an appropriate for and/or
recommended standard of care in the delivery of these services?
How are data that are collected by the technology
maintained for recordkeeping and care coordination?
What information exists about how an episode of care
should be defined, particularly in circumstances when a patient may
receive concurrent RTM or digital CBT services from two different
clinicians engaged in separate episodes of care?
We noted in previous rulemaking that even when multiple
medical devices are provided to a patient, the services associated with
all the medical devices can be billed by only one practitioner, only
once per patient, per 30-day period, and only when at least 16 days of
data have been collected. We sought information on the type and
frequency of circumstances that involve multiple medical devices and
multiple clinicians. How might allowing multiple, concurrent RTM
services for an individual beneficiary affect access to health care,
patient out-of-pocket costs, the quality of care, health equity, and
program integrity?
Do interested parties believe digital CBT could be billed
using the existing remote therapeutic monitoring codes described by CPT
codes 98975, 98980, and 98981? What impediments may exist to using
these codes for digital CBT?
In the past, commenters generally supported the concept of
a generic RTM device code, and offered a wide variety of possible use
cases, including where FDA approved devices and devices that have gone
through other premarket pathways exist for the purpose of monitoring
various conditions that do not meet the current scope of the existing
RTM codes.
++ What are the advantages and disadvantages of a generic RTM
device code, versus specific RTM codes?
++ Would generic device codes undermine or stall progress toward a
wider set of specific codes that would provide less ambiguity on
reimbursement?
[[Page 79013]]
++ How might generic RTM codes for supply of a device be valued
given the broad array of pricing models?
What scientific and clinical evidence of effectiveness
should CMS consider when determining whether digital therapeutics for
behavioral health are reasonable and necessary?
What aspects of digital therapeutics for behavioral health
should CMS consider when determining whether it fits into a Medicare
benefit category, and which category should be used?
If CMS determines the services fit within an existing
Medicare benefit category or if other coverage requirements are met,
what aspects of delivering digital cognitive based therapy services
should be considered when determining potential Medicare payment? Under
current practice models, are these products used as incident-to
supplies or are they used independent of a patient visit with a
practitioner? If used independently of a clinic visit, does a
practitioner issue an order for the services?
Are there barriers to digital CBT reaching underserved
populations, and would a supervision requirement impact access to
digital CBT for underserved populations?
What strategies, if any, within the digital therapeutics
for behavioral health support disadvantaged/hard to reach populations
in advancing equity in health care services?
What are some potential considerations for protecting the
privacy and confidentiality of the patient population in digital
therapeutics, including compliance with State behavioral health privacy
requirements?
We received public comments in response to our request for
information on Digital Therapies, such as, but not limited to, digital
Cognitive Behavioral Therapy. The following is a summary of the
comments we received and our responses.
Comment: We received many detailed comments in response to our
Request for Information on digital therapies, such as, but not limited
to, digital Cognitive Behavioral Therapy. Some commenters stated that
CMS has existing authority to pay for two types of digital
therapeutics: those that meet the definitions of durable medical
equipment (DME) and those that are used incident to a physician
service, assuming other relevant criteria are met. The commenters
suggested that CMS should continue to use their authority to code and
pay for digital therapeutics that are cleared by the FDA consistent
with other prescription medical devices that fall under these existing
benefit categories, and that are reasonable and necessary for the
treatment of illness or injury. Additionally, the commenters stated
that regarding coding and payment under the PFS for digital
therapeutics that are furnished incident-to a physician's service, they
noted that there are new coding proposals shown in the public agenda
for the September 2023 CPT Editorial Panel meeting to allow for
reporting of digital CBT (dCBT) and remote therapeutic treatment and
other digital therapeutics as incident-to services. These commenters
stated that such coding would provide an appropriate mechanism to
facilitate coverage when furnished incident-to a healthcare
practitioner's service and stated that if such coding is not adopted,
they would encourage CMS to use its authority to adopt such coding
under the HCPCS system where CMS would establish a separate set of G-
codes to account for when digital therapeutic devices are acquired by a
Medicare enrolled practitioner, and that practitioner then furnishes
that device to a patient and manages their treatment.
Response: We thank the commenters for their detailed feedback on
this topic. In the CY 2023 PFS final rule (87 FR 69645 through 69649),
we accepted the RUC's recommendation to contractor price CPT code
98978, a PE-only code that describes provision of a monitoring device
for CBT and noted that we would work with our Medicare Administrative
Contractors (MACs) to better understand the kinds of devices and device
costs they are encountering as they review claims for payment for the
services described by this code. Additionally, we note that the
existing codes described by CPT codes 98978, 98980, and 98981 allow for
the billing of remote therapeutic monitoring services, including
monitoring patient adherence and therapy response for use with
cognitive behavioral therapy. In response to the commenters' statement
that there are new coding proposals shown in the public agenda for the
September 2023 CPT Editorial Panel meeting to allow for reporting of
digital CBT (dCBT) and remote therapeutic treatment and other digital
therapeutics as incident-to services, we note that we routinely rely on
the CPT coding process as a critical part of how services, including
those involving emerging technologies, that might be paid under the PFS
are understood and provided by medical professionals. While we do not
always rely on CPT exclusively, we look forward to reviewing any
forthcoming codes and potential recommendations for the valuation of
such codes through our standard annual processes. Additionally, we
continue to be interested in any feedback from interested parties on
this topic, including feedback from interested parties about any
potential codes that we would review under those processes and
considerations we might need to take into account for future rulemaking
to improve the accuracy of coding and payment under the Medicare PFS.
For example, we welcome nominations for potentially misvalued codes and
refer to the public nomination process outlined in section II.C. of
this final rule, which can be used to help us identify codes that
should be prioritized for review through the RUC process as well as
resource costs involved in furnishing reasonable and necessary care to
Medicare beneficiaries that are not accurately reflected under existing
coding and payment policies. In some specific cases, of course, we have
identified the need to develop G-codes as part of proposals to improve
accuracy of payment for services paid under the PFS.
In response to the comments regarding DME, we note that for a
digital therapeutic item to be designated as DME it must meet the
Medicare definition of DME. DME is defined in section 1861(n) of the
Act and Medicare regulations at 42 CFR 414.202, and means equipment
furnished by a supplier or a home health agency that meets the
following conditions: (1) Can withstand repeated use; (2) Effective
with respect to items classified as DME after January 1, 2012, has an
expected life of at least 3 years; (3) Is primarily and customarily
used to serve a medical purpose; (4) Generally is not useful to an
individual in the absence of an illness or injury; and (5) Is
appropriate for use in the home. All five of these conditions must be
met in order for equipment to be classified as DME.
K. Provisions on Medicare Parts A and B Payment for Dental Services
Inextricably Linked to Specific Covered Services
1. Medicare Payment for Dental Services
a. Overview
Section 1862(a)(12) of the Act generally precludes payment under
Medicare Parts A or B for any expenses incurred for services in
connection with the care, treatment, filling, removal, or replacement
of teeth or structures directly supporting teeth. (Collectively here,
we will refer to ``the care, treatment, filling, removal, or
replacement of teeth or structures directly supporting teeth'' as
``dental services.'') In the CY 2023 PFS final rule
[[Page 79014]]
(87 FR 69663 through 69688), we identified certain clinical scenarios
where payment is permitted under both Medicare Parts A and B for
certain dental services in circumstances where the services are not
considered to be in connection with dental services within the meaning
of section 1862(a)(12) of the Act.
The regulation at Sec. 411.15(i)(3)(i) includes examples of
services for which payment can be made under Medicare Parts A and B for
dental services, furnished in an inpatient or outpatient setting, that
are inextricably linked to, and substantially related to the clinical
success of, certain other covered services (hereafter in this section,
``inextricably linked to other covered services'').
Recognizing that there may be other instances where covered
services necessary to diagnose and treat the individual's underlying
medical condition and clinical status may require the performance of
certain dental services, in the CY 2024 PFS proposed rule we proposed
to codify other instances where dental services are inextricably linked
to other covered services such that they are not in connection with
dental services within the meaning of section 1862(a)(12) of the Act
(88 FR 52371 through 52384). At the same time, we continue to recognize
that there are dental services that are not, or currently not evidenced
to be, inextricably linked to other covered services. In these
instances, we continue to believe that Medicare payment is precluded by
section 1862(a)(12) of the Act, except when, due to the patient's
underlying medical condition and clinical status or the severity of the
dental procedure, hospitalization is required; and that in those
instances, the Medicare Part A exception provided under section
1862(a)(12) of the Act will apply.
In the CY 2023 PFS final rule (87 FR 69682, 69685, 69687), we also
established a process for the public to submit additional dental
services that may be inextricably linked to other covered services for
our consideration and review and finalized a policy to permit payment
for certain dental services, such as dental examinations and necessary
treatment, prior to or contemporaneously with the treatment of head and
neck cancers, beginning in CY 2024. The process for the public to
submit comments is discussed below.
In the CY 2024 PFS proposed rule, we proposed to codify in section
Sec. 411.15(i)(3)(i)(A) additional policies to permit payment for
certain dental services that are inextricably linked to other covered
services. We also proposed to make non-substantive technical changes to
improve the clarity of the regulation text (88 FR 52740).
b. Other Medical Services for Which Dental Services May Be Inextricably
Linked
In the CY 2023 PFS final rule, we discussed whether we should
specify that payment can be made under Medicare Parts A and B for
certain dental services prior to the initiation of immunosuppressant
therapy, joint replacement procedures, or other surgical procedures. We
stated that we remain committed to exploring the inextricable link
between dental and covered services associated with immunosuppressant
therapy, joint replacement surgeries, and other surgical procedures and
that we welcomed continued engagement with the public to review the
clinical evidence to determine whether certain dental services were
inextricably linked to other covered services (87 FR 69668 and 69680
through 69686).
We partnered with researchers at the Agency for Healthcare Research
and Quality (AHRQ) to consider the relationship between dental services
and specific covered services and reviewed available clinical evidence
regarding the relationship between dental services and medical services
in the treatment of cancer using chemotherapeutic agents, which may
lead to more clinically severe infections and often involve
immunosuppression in patients.57 58 The AHRQ report \59\
regarding dental services and the link between medical services is
available at https://effectivehealthcare.ahrq.gov/sites/default/files/related_files/rapid-response-chemotherapy-dental.pdf. For example, it
is generally understood that many chemotherapeutic agents used in the
treatment of cancer target rapidly proliferating cells (which include
those cells found in healthy tissue, like the oral mucosa). This
targeting of rapidly reproducing cells in the oral mucosa can lead to
the development of oral mucositis, which can negatively affect
individuals with periodontitis and other dental conditions more
severely, especially when exposed to higher doses/duration of
chemotherapy.\60\ Another example of a dental-related issue resulting
from covered services that are immunosuppressive in nature is
medication-related osteonecrosis of the jaw (MRONJ). MRONJ may occur as
an adverse effect when patients with cancer receive specific covered
services, such as high-dose antiresorptive and/or antiangiogenic drug
therapy (for example, high doses of bisphosphonates or drugs like
denosumab used to treat osteoporosis) or bone-modifying therapy in
conjunction with their chemotherapy regimen. Patients with existing
dental disease are most at risk for developing MRONJ secondary to bone-
modifying therapy. MRONJ complicates the cancer treatment and can
reduce survival rates up to 3 years post-treatment.\61\ Dental services
to identify and treat oral complications/comorbidities prior to and,
sometimes, throughout chemotherapy treatment have been associated with
improved outcomes for the patient receiving medical services in the
treatment of cancer.\62\ Further, AHRQ noted that there is abundant
worldwide experience and related standards of care in the management of
patients whose medical conditions require chemotherapy regimens that
induce immunosuppression and that this experience has led to an
understanding of how improved dental care potentially can reduce the
incidence of serious infections and improve overall patient outcomes.
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\57\ Immunosuppression describes an impairment of the cells of a
patient's immune system and a reduction in their ability to fight
infections and other diseases.
\58\ National Cancer Institute. NCI Dictionary of Cancer Terms.
2019. Available at https://www.cancer.gov/publications/dictionaries/cancer-terms.
\59\ Hickam DH, Gordon CJ, Armstrong CE, Coen MJ, Paynter R,
Helfand M. The Efficacy of Dental Services for Reducing Adverse
Events in Those Receiving Chemotherapy for Cancer. Rapid Response.
(Prepared by the Scientific Resource Center under Contract No.
75Q80122C00002.) AHRQ Publication No. 23-EHC021. Rockville, MD:
Agency for Healthcare Research and Quality; June 2023. DOI: https://doi.org/10.23970/AHRQEPCRAPIDDENTALCANCER.
\60\ Poulopoulos A, Papadopoulos P, Andreadis D. Chemotherapy:
oral side effects and dental interventions -a review of the
literature. Stomatological Disease and Science. 2017; 1:35-49.
http://dx.doi.org/10.20517/2573-0002.2017.03.
\61\ Corraini, P., Heide-J[oslash]rgensen, U., Schi[oslash]dt,
M., N[oslash]rholt, S. E., Acquavella, J., S[oslash]rensen, H. T., &
Ehrenstein, V. (2017). Osteonecrosis of the jaw and survival of
patients with cancer: a nationwide cohort study in Denmark. Cancer
medicine, 6(10), 2271-2277. https://doi.org/10.1002/cam4.1173.
\62\ Poulopoulos A, Papadopoulos P, Andreadis D. Chemotherapy:
oral side effects and dental interventions -a review of the
literature. Stomatological Disease and Science. 2017; 1:35-49.
http://dx.doi.org/10.20517/2573-0002.2017.03.
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The AHRQ examined the effects of dental care prior to treatment on
the success of medical services for patients receiving chemotherapy
regimens (primary medical service) in the treatment of cancer (primary
medical illness). As part of this analysis, AHRQ identified 26 primary
research studies, seven systematic reviews, and five practice
guidelines that outline the benefits and harms of pre-treatment dental
services and their effects on cancer chemotherapy regimens. The
[[Page 79015]]
studies were selected using specific inclusion criteria: a sample of
patients beginning cancer treatment within 2 months; targeted dental
services occurring prior to cancer treatment; outcomes data, such as
rates of serious adverse events, quality of life, cancer relapse rates,
mortality, or adherence to cancer treatment; and a minimum sample size
of 10 patients.
The 26 primary research studies identified by AHRQ included
prospective cohort studies, retrospective cohort studies, randomized
controlled trials, and registry-based studies. From this group of
studies, AHRQ found evidence to support that dental evaluation/
treatment prior to cancer treatment led to decreased incidence and/or
less severity of serious oral infections and complications (such as,
oral mucositis and osteonecrosis) with the covered services, as well as
requiring fewer emergency treatments.63 64 There was further
evidence found in systematic reviews that showed a possible increased
incidence of oral mucositis when dental treatment is not administered
at least 2-3 weeks prior to initiation of cancer treatment, further
complicating the totality of services a patient received to treat their
cancer.\65\ They note that treatment of a broad range of malignancies
often requires the use of chemotherapeutic agents that suppress the
body's production of white blood cells, thereby impairing the body's
ability to resist serious (often life-threatening) bacterial and fungal
infections, and that the route of entry of these offending bacteria can
be the mouth. AHRQ also analyzed several clinical practice guidelines
that supported a dental evaluation/treatment before initiating
chemotherapy so that any oral complications could be mitigated prior to
initiating care to treat the cancer.66 67 68
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\63\ Watson EE, Metcalfe JE, Kreher MR, et al. Screening for
Dental Infections Achieves 6-Fold Reduction in Dental Emergencies
During Induction Chemotherapy for Acute Myeloid Leukemia. JCO Oncol
Pract. 2020 11;16(11):e1397-e405. doi: https://dx.doi.org/10.1200/OP.20.00107. PMID: 32609586.
\64\ Owosho AA, Liang STY, Sax AZ, et al. Medication-related
osteonecrosis of the jaw: An update on the memorial sloan kettering
cancer center experience and the role of premedication dental
evaluation in prevention. Oral Surg Oral Med Oral Pathol Oral
Radiol. 2018 May;125(5):440-5. doi: https://dx.doi.org/10.1016/j.oooo.2018.02.003. PMID: 29580668.
\65\ Mazzetti T, Sergio da Silva Santos P, Spindola Antunes H,
et al. Required time for pre-oncological dental management--A rapid
review of the literature. Oral Oncol. 2022 11;134:106116. doi:
https://dx.doi.org/10.1016/j.oraloncology.2022.106116. PMID:
36115328.
\66\ Elad S, Cheng KKF, Lalla RV, et al. MASCC/ISOO clinical
practice guidelines for the management of mucositis secondary to
cancer therapy. Cancer. 2020 Oct 1;126(19):4423-31. doi: https://dx.doi.org/10.1002/cncr.33100. PMID: 32786044.
\67\ Yarom N, Shapiro CL, Peterson DE, et al. Medication-Related
Osteonecrosis of the Jaw: MASCC/ISOO/ASCO Clinical Practice
Guideline. J Clin Oncol. 2019 Sep 1;37(25):2270-90. doi: https://dx.doi.org/10.1200/JCO.19.01186. PMID: 31329513.
\68\ Butterworth C, McCaul L, Barclay C. Restorative dentistry
and oral rehabilitation: United Kingdom National Multidisciplinary
Guidelines. J Laryngol Otol. 2016 May;130(S2):S41-S4. PMID:
27841112.
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c. Submissions Received Through Public Submission Process
In the CY 2023 PFS final rule, we stated that we believed there may
be additional clinical scenarios we have not yet identified under which
Medicare payment could be made for certain dental services on the basis
that dental services are inextricably linked to other covered services
(87 FR 69686). In order to ensure we are appropriately considering
other potential clinical scenarios that may involve such dental
services, we finalized an annual public process, including notice and
comment rulemaking, whereby interested parties can submit
recommendations for other clinical scenarios for potential inclusion on
the list of dental services for which payment can be made under Sec.
411.15(i)(3)(i).
Through this process, we stated that we would review clinical
evidence to assess whether there is an inextricable link between
certain dental and covered services because the standard of care for
that medical service is such that one would not proceed with the
medical procedure or service without performing the dental service(s)
because the covered services would or could be significantly and
materially compromised absent the provision of the inextricably-linked
dental services, or where dental services are a clinical prerequisite
to proceeding with the primary medical procedure and/or treatment (87
FR 69685). We also stated that, section 1862(a)(12) of the Act does not
apply only when dental services are inextricably linked to other
covered services, such that the standard of care for that medical
service would be compromised or require the dental services to be
performed in conjunction with the covered services (87 FR 69666). As
such, we requested that documentation accompanying recommendations
should include medical evidence to support that certain dental services
are inextricably linked to other covered services. Specifically, we
requested that the medical evidence should:
(1) Provide support that the provision of certain dental services
leads to improved healing, improved quality of surgery outcomes, and
the reduced likelihood of readmission and/or surgical revisions because
an infection has interfered with the integration of the medical implant
and/or interfered with the medical implant to the skeletal structure;
(2) Be clinically meaningful and demonstrate that the dental
services result in a material difference in terms of the clinical
outcomes and success of the procedure such that the dental services are
inextricably linked to other covered services; and
(3) Be compelling to support that certain dental services would
result in clinically significant improvements in quality and safety
outcomes (for example, fewer revisions, fewer readmissions, more rapid
healing, quicker discharge, and quicker rehabilitation for the patient)
(87 FR 69686).
We stated that interested parties should submit medical evidence to
support, for the recommended clinical scenario, the inextricable link
between certain dental services and other covered services by providing
any of the following:
(1) Relevant peer-reviewed medical literature and research/studies
regarding the medical scenarios requiring medically necessary dental
care;
(2) Evidence of clinical guidelines or generally accepted standards
of care for the suggested clinical scenario;
(3) Other ancillary services that may be integral to the covered
services; and/or
(4) Other supporting documentation to justify the inclusion of the
proposed medical clinical scenario requiring dental services (87 FR
69686, 69687).
We stated that we intended to use the PFS annual rulemaking process
to discuss public submissions when considering whether the recommended
dental services associated with certain clinical scenarios should be
considered outside the scope of the general preclusion on payment for
dental services under section 1862(a)(12) of the Act because they are
inextricably linked to other covered services. We believe that public
feedback is important, especially when considering Medicare payment for
dental services that may benefit the clinical outcomes for certain
covered services. We believe that using our annual notice and comment
rulemaking process to discuss submitted recommendations will allow the
public to comment and submit further medical evidence to assist us in
evaluating whether certain dental services furnished in certain
clinical scenarios would meet the standard to permit
[[Page 79016]]
Medicare payment for the dental services. Under the public process
established in the CY 2023 PFS final rule, recommendations received by
February 10th of a calendar year would be reviewed for consideration
and potential inclusion within the PFS proposed rule for the subsequent
calendar year. The deadline for submissions for potential consideration
for CY 2024 rulemaking was February 10, 2023. We received eight
submissions from various organizations on or before February 10, 2023.
We received one submission after the deadline that presented
nominations for covered services that have already been addressed by
this payment policy.
Submissions included recommendations for payment under Medicare
Parts A and B of dental services prior to covered services associated
with the treatment of cancer (chemotherapy, chimeric antigen receptor
(CAR) T-cell therapy, bone-modifying agents or antiresorptive therapy),
total joint arthroplasty, all cardiovascular procedures, diabetes
treatment, treatment for sickle-cell anemia and hemophilia, and
systemic autoimmune diseases. Additionally, many submissions
recommended that CMS refine certain terminology surrounding previously
finalized policies, specifically around whether payment can be made for
dental services furnished during and after the performance of certain
covered services.
Several submissions recommended that Medicare make payment under
Parts A and B for dental services prior to covered services associated
with the treatment of patients with leukemia and lymphoma, as well as
other cancers. Most submitting organizations stated that, by examining
and addressing the oral health of the patient prior to the initiation
of chemotherapy in the treatment of cancer, with or without radiation,
oral complications could be appropriately addressed or prevented that
would improve the clinical success of the overall cancer treatment.
Submissions also recommended Medicare payment under Parts A and B for
dental services before, during, and after CAR T-cell therapy and other
lymphodepleting covered services (lymphodepleting therapy involves a
short course of chemotherapy that targets T-cells, preconditioning the
body prior to enhance treatments like CAR T-cell therapy). These
submissions stressed the need to detect and monitor dental issues early
to avoid the increased risk of related infections and complications.
Most submissions stated that medication-related osteonecrosis of
the jaw (MRONJ) is a serious complication of antiresorptive and/or
antiangiogenic drug therapy used to help manage the treatment of
cancer. Several recommended that Medicare make payment under Parts A
and B for dental services for patients where high-dose bisphosphonate
therapy for cancers is indicated, such as blood and solid tumor cancers
and metastatic cancers associated with the risk of osteonecrosis of the
jaw. These submissions recommended payment of dental services prior to
and during antiresorptive therapy or prior to, during, and after the
use of bone-modifying drugs. One provided references that support the
provision of dental services to prevent, or as part of treatment for
MRONJ. Another submission stated that the risk of MRONJ is
significantly greater in patients receiving antiresorptive therapy in
connection with cancer treatment compared to patients receiving
antiresorptive therapy for osteoporosis.\69\ However, the submitter
stated that the combination of poly-pharmaceutical management of cancer
patients and related immunosuppression are risk factors for MRONJ
without exposure to antiresorptive agents and that it would be
difficult to identify a single medication as the etiologic agent for
MRONJ in case reports or mini-case series. The submitter stated that
prevention of MRONJ would be the clinical gold standard.
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\69\ We note that antiresorptive therapy for cancer is the
parenteral administration of bisphosphonates and denosumab, also
called osteoclast inhibitors, for the purpose of reducing the
frequency of skeletal complications (for example, fractures) in
patients with multiple myeloma and in those with bone metastases
from solid tumors. Per FDA label, they are administered parenterally
and in doses that exceed those typically used for patients with
osteoporosis. (Only two bisphosphonates, pamidronate and zoledronic
acid, and the single monoclonal antibody, denosumab, have the cancer
indication).
Antiresorptive therapy for osteoporosis is typically for the
postmenopausal female patient, for the purpose of reducing the risk
of skeletal fracture (for example, vertebral, hip) in those patients
who have a high fracture risk. They are typically dosed orally, at
dosages that have significant supportive efficacy and safety data.
Parenteral administration of bisphosphonates is available for
osteoporosis for patients that are unable to take an oral
preparation, at significantly lower dosages.
For example, the dosage difference for zoledronic acid between
the two indications would be as follows: cancer (for example,
multiple myeloma, bone metastases) at 4 mg IV every 3 to 4 weeks
compared with osteoporosis at 5 mg every 12 months.
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One submission also recommended that Medicare make payment under
Parts A and B for dental services prior to all cardiovascular
procedures. In their view, the provision of dental services to reduce
the risk of perioperative and postoperative infection and complications
is critical to ensure optimal surgical outcomes for all patients
requiring invasive and/or interventional cardiac procedures. They cited
a literature review supporting the need for screening and treatment for
oral/dental infections before cardiac surgery. This submission did not
recommend dental services prior to a specific cardiovascular procedure;
rather, it recommended dental services prior to all cardiovascular
procedures. The literature review they cited (which we discuss in
section II.K.3. of this final rule) noted that there was a mixture of
medical literature to support the performance of dental services prior
to all cardiac procedures in part because such cardiovascular
procedures are more urgent or emergent than elective.
One submission recommended that Medicare make payment under
Medicare Parts A and B for dental services prior to joint replacement
surgeries, specifically total knee and hip arthroplasty. The submitting
organization stated that providing dental services prior to or
contemporaneously with joint replacement surgeries may result in more
rapid healing and quicker rehabilitation, especially if a known dental
infection could be addressed and potentially prevent surgical and
rehabilitation complications for the patient. However, the submission
acknowledged that there is no consensus on whether performing dental
services prior to joint replacement surgeries improves the clinical
outcomes of the medical service or whether it is typical in practice to
furnish dental services before joint replacement procedures.
Other submissions recommended Medicare make payment for dental
services for patients diagnosed with a specific condition(s), such as
patients with poorly controlled diabetes mellitus or individuals living
with sickle cell disease (SCD) or hemophilia.
Submissions also recommended Medicare payment for dental services
for persons affected by systemic autoimmune disease. They argued that
dental services are essential for medical treatment for individuals at
much higher risk of advanced dental decay, dental loss, and/or gum
disease. They stated that reducing oral infection of the mucosa, teeth,
and gums; oral inflammation; and tooth loss through consistent oral
management reduces the systemic impact that these dental conditions
have on a patient's systemic autoimmune disease. One submission stated
that oral health disparities
[[Page 79017]]
disproportionately affect members of racial or ethnic minority groups,
which they offered is most pronounced in populations aged 65 and older.
Another presented their proposal to bridge the gap in health equity and
to improve the health outcomes for those ages 65 and older living with
autoimmune diseases.
We thanked all those who submitted recommendations for clinical
scenarios for which they believe Medicare payment for dental services
will be consistent with the policies we codified and clarified in the
CY 2023 PFS final rule at Sec. 411.15(i)(3)(i), under which Medicare
payment may be made for dental services when they are inextricably
linked to, and substantially related and integral to the clinical
success of, certain covered medical services (hereafter in this
section, ``inextricably linked to other covered services''). We
continued to encourage interested parties to engage with us regularly
and to submit recommendations for our consideration of additional
clinical scenarios where dental services may be inextricably linked to
other covered services. As stated earlier, interested parties should
provide evidence to support or refute that at least one of the three
criteria listed above for submissions is met. Furthermore, submissions
should focus on the inextricably linked relationship between dental
services and other medical services necessary to diagnose and treat the
individual's underlying medical condition and clinical status, and
whether it is not clinically advisable to move forward with the primary
medical service without performing certain dental services. We remind
readers once again that, to be considered for purposes of CY 2025 PFS
rulemaking, submissions through our public process for recommendations
on payment for dental services should be received by February 10, 2024,
via email at [email protected]. Interested
parties should include the words ``dental recommendations for CY 2025
review'' in the subject line of their email submission to facilitate
processing. We continue to stress to submitters that recommendations
must include at least one of the types of evidence listed earlier when
submitting documentation to support the inextricable link between
specified dental services and other covered services. We further note
that we may also consider recommendations that are submitted as public
comments during the comment period following the publication of the PFS
proposed rule.
2. Additions to Current Policies Permitting Payment for Dental Services
Inextricably Linked to Other Covered Services
Under our current policy, we have identified several clinical
scenarios where dental services are inextricably linked to other
covered services that is covered by Medicare, such that Medicare
payment for the dental services is not precluded by section 1862(a)(12)
of the Act. After further review of current medical practice, and
through internal and external consultations and consideration of the
submissions received through the public process established in the CY
2023 PFS final rule (87 FR 69669), we believe there are additional
circumstances that are clinically similar to the scenarios we codified
in our regulation at Sec. 411.15(i)(3)(i) as examples of clinical
scenarios under which Medicare payment may be made for certain dental
services because they are inextricably linked to other covered medical
services.
As described in the CY 2024 PFS proposed rule, in the case of the
proposed primary-covered services, we believe that dental services are
inextricably linked to, and substantially related and integral to the
clinical success of, the proposed covered services because such dental
services serve to mitigate the substantial risk to the success of the
medical services, due to the occurrence and severity of complications
caused by the primary medical services, including infection (88 FR
52374 through 52380). Additionally, section 1862(a)(12) of the Act does
not apply only when dental services are inextricably linked to, and
substantially related and integral to the clinical success of, certain
other covered services, such that the standard of care for that medical
service would be compromised or require the dental services to be
performed in conjunction with the covered services or if the dental
services are considered to be a critical clinical precondition to
proceeding with the primary medical procedure and/or treatment. As
such, we believed the certain dental services are not in connection
with the care, treatment, filling, removal, or replacement of teeth or
structures directly supporting teeth, but instead are inextricably
linked to, and substantially related and integral to the clinical
success of, the following medical services, and we proposed that the
statutory dental exclusion would not apply:
(1) Chemotherapy when used in the treatment of cancer;
(2) CAR T-Cell therapy, when used in the treatment of cancer; and
(3) Administration of high-dose bone-modifying agents
(antiresorptive therapy) when used in the treatment of cancer.
As such, we proposed to revise our regulation at Sec.
411.15(i)(3)(i)(A) by adding to the list of clinical scenarios in which
Medicare Part A and B payment is permitted for dental or oral
examinations performed as part of a comprehensive workup prior to, and
medically necessary diagnostic and treatment services to eliminate an
oral or dental infection prior to, or contemporaneously with, the
following Medicare-covered services: chemotherapy, chimeric antigen
receptor (CAR) T-cell therapy, and the administration of high-dose
bone-modifying agents (antiresorptive therapy) when used in the
treatment of cancer.
a. Dental Services Inextricably Linked to Chemotherapy Services When
Used in the Treatment of Cancer
In the CY 2024 PFS proposed rule, we discussed clinical practice
guidelines, recommendations provided by the public, and our analyses of
the studies and research available regarding the connection between
dental services and the clinical success of chemotherapy services. We
stated that there is an inextricable link between certain dental and
chemotherapy services when used in the treatment of cancer because the
standard of care is such that one would not proceed with the medical
procedure or service without performing the dental service(s) because
the covered medical services would or could be significantly and
materially compromised absent the provision of the inextricably-linked
dental services and that dental services are a clinical prerequisite to
proceeding with the chemotherapy services when used in the treatment of
cancer (88 FR 52377). Chemotherapy services, when used in the treatment
of cancer, cause immunosuppression which may lead to significant oral
complications and adverse events, including the possibility of an oral
or dental infection, which in turn leads to serious and imminent risks
to the success of the primary medical procedures and treatments. The
complications, including possible infection, may prevent the ability to
both initiate and proceed with the primary, covered medical service
(that is, lead to delays in treatment and/or cause inability of the
patient to complete the course of treatment, thereby potentially
reducing the effectiveness of the therapy) such that the standard of
care would be to not
[[Page 79018]]
proceed with the covered medical procedure until a dental or oral exam
is performed to address the oral complications and/or clear the patient
of an oral or dental infection. In the case of chemotherapy services
when used in the treatment of cancer, dental services serve to mitigate
the likelihood of occurrence and severity of complications caused by
the primary medical services, including infection, and consequently the
dental services facilitate the successful completion of the prescribed
course of treatment. Therefore, we believed the dental services are
integral and inextricably linked to the chemotherapy when used in the
treatment of cancer, and the statutory dental exclusion under section
1862(a)(12) of the Act would not apply.
We proposed to add this clinical scenario to the examples of
clinical scenarios under which payment can be made for certain dental
services in our regulation at Sec. 411.15(i)(3)(i)(A). Specifically,
we proposed to amend the regulation to include dental or oral
examination performed as part of a comprehensive workup in either the
inpatient or outpatient setting prior to Medicare-covered chemotherapy
when used in the treatment of cancer; and, medically necessary
diagnostic and treatment services to eliminate an oral or dental
infection prior to, or contemporaneously with chemotherapy when used in
the treatment of cancer. We solicited comments on all aspects of this
proposal.
Additionally, we noted that we proposed that payment is permitted
for dental services that are inextricably linked to chemotherapy used
in the treatment of cancer with or without the use of other therapy
types, including radiation therapy in the treatment of cancer. That is,
this provision is not meant to be limited to cases where chemotherapy
in the treatment of cancer is provided without the use of other
therapies. We solicited comment on this aspect of the proposal.
As discussed in section II.K.2. of this final rule, we received
submissions through the public process and comments on the CY 2023 PFS
proposed rule requesting that Medicare payment should be permitted
under Parts A and B for dental services when medical services that
cause immunosuppression are being provided to treat a variety of
medical conditions.
Commenters asserted that immunocompromised patients are at an
increased risk of serious infection that can lead to severe conditions
(87 FR 69683). We stated that we agreed with commenters that
individuals who are immunocompromised may be prone to serious
infection, and that we will continue to consider feedback and the
clinical literature provided by interested parties to determine whether
there are other clinical scenarios, such as the initiation of
immunosuppressive therapies, where Medicare payment should not be
excluded for dental services under section 1862(a)(12) of the Act,
because the services are inextricably linked to other covered services.
In the CY 2023 PFS final rule (87 FR 69681) and as discussed in
section II.K.2. of this final rule, we stated that we were finalizing a
policy for CY 2024 that Medicare Parts A and B payment may be made for
dental or oral examination performed as part of a comprehensive workup
in either the inpatient or outpatient setting, as well as medically
necessary diagnostic and treatment services to eliminate an oral or
dental infection, prior to or contemporaneously with Medicare-covered
treatments for head and neck cancer. We stated that removing infections
in the oral cavity is necessary to prepare patients for treatment and
is inextricably linked to the clinical success of treatment for cancers
of the head and neck. There is significant and abundant worldwide
experience and research regarding the care of patients whose medical
conditions require chemotherapy regimens that induce acute
immunosuppression.70 71 The treatment of a broad range of
malignancies often requires chemotherapeutic agents that, in turn,
suppress the body's production of white blood cells, thereby impairing
the body's ability to resist serious (potentially life-threatening)
infections. The route of entry of the offending pathogens can be the
mouth.72 73 74 Therefore, individuals receiving chemotherapy
treatment for cancer who become immunosuppressed may be more
susceptible to infection and other adverse events with serious
consequences for the patient. We understand that medical services used
in cancer treatment, such as chemotherapy, induce immunosuppression. As
such, we believe that cancer patients being treated with chemotherapy
represent an acutely impacted, immunocompromised patient population due
to the nature of the effects of such chemotherapy treatment. If dental
or oral infections are left undetected or untreated in these patients,
serious complications may occur, negatively impacting the clinical
success of the medical services and outcomes for the patients.
Moreover, the immunosuppression induced by the chemotherapy medical
services in cancer treatment increases the likelihood and intensity of
complications for the patient that could potentially jeopardize or
impact the ability to complete the totality of the treatment across a
normal course of treatment.75 76 If an oral or dental
infection is not properly diagnosed and treated prior to and/or during
the chemotherapy in the treatment of cancer, which suppresses the
immune system, there may be an increased risk for local and systemic
infections from odontogenic sources. Furthermore, the successful
completion of that treatment could be compromised. Additionally, if
such an infection is not treated, then there is an increased likelihood
of morbidity and mortality resulting from the spreading of the local
infection to sepsis.77 78
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\70\ Spijkervet FKL, Schuurhuis JM, Stokman MA, et al. Should
oral foci of infection be removed before the onset of radiotherapy
or chemotherapy? Oral Dis. 2021 Jan;27(1):7-13. doi: https://dx.doi.org/10.1111/odi.13329. PMID: 32166855.
\71\ Hanna N, Einhorn LH. Testicular cancer: a reflection on 50
years of discovery. J Clin Oncol. 2014 Oct 1;32(28):3085-92. doi:
https://dx.doi.org/10.1200/JCO.2014.56.0896. PMID: 25024068.
\72\ Mirowski GW, Bettencourt JD, Hood AF. Oral infections in
the immunocompromised host. Semin Cutan Med Surg. 1997
Dec;16(4):249-56. doi: https://dx.doi.org/10.1016/s1085-5629(97)80013-2. PMID: 9421215.
\73\ Greenberg MS, Cohen SG, McKitrick JC, et al. The oral flor
as a source of septicemia in patients with acute leukemia. Oral Surg
Oral Med Oral Pathol. 1982 Jan;53(1):32-6. PMID: 6948251.
\74\ King A, Irvine S, McFadyen A, et al. Do we overtreat
patients with presumed neutropenic sepsis? Postgrad Med J. 2022
Nov;98(1165):825-9. doi: https://dx.doi.org/10.1136/postgradmedj-2021-140675. PMID: 34611037.
\75\ Spijkervet FKL, Schuurhuis JM, Stokman MA, et al. Should
oral foci of infection be removed before the onset of radiotherapy
or chemotherapy? Oral Dis. 2021 Jan;27(1):7-13. doi: https://dx.doi.org/10.1111/odi.13329. PMID: 32166855.
\76\ Hanna N, Einhorn LH. Testicular cancer: a reflection on 50
years of discovery. J Clin Oncol. 2014 Oct 1;32(28):3085-92. doi:
https://dx.doi.org/10.1200/JCO.2014.56.0896. PMID: 25024068.
\77\ Ruescher TJ, Sodeifi A, Scrivani SJ, Kaban LB, Sonis ST.
The impact of mucositis on alpha-hemolytic streptococcal infection
in patients undergoing autologous bone marrow transplantation for
hematologic malignancies. Cancer 1998;82(11):2275-2281. [PubMed:
9610710].
\78\ Vera-Llonch M, Oster G, Ford CM, Lu J, Sonis S. Oral
mucositis and outcomes of allogeneic hematopoietic stem-cell
transplantation in patients with hematologic malignancies. Support
Care Cancer May;2007 15(5):491-496. [PubMed: 17139495].
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Individuals undergoing chemotherapy services used in the treatment
of cancer who become immunosuppressed by the treatment may also
experience oral mucositis, which often facilitates the entry of oral
bacteria into the body, potentially increasing the risk of infection
for the patient and compromising the chemotherapy
[[Page 79019]]
regimen. The risk of mucositis and potential complications to the
clinical success of medical services for cancer treatment is similar to
the risk for patients receiving Hematopoietic Stem Cell Transplants
(HSCT) and bone marrow transplants,79 80 for which we
finalized payment for certain dental services prior to these medical
services (87 FR 69677). These potential complications, resulting from
the combined immunosuppression and mucositis caused by the chemotherapy
services, present a risk to the patient and the success of the medical
chemotherapy regimen unless mitigated by the provision of dental
services. Additionally, as described previously, evidence found in
systematic reviews showed a possible increased incidence of oral
mucositis when dental treatment is not administered at least 2-3 weeks
prior to initiation of cancer treatment, further complicating the
totality of services a patient received to treat their cancer.\81\
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\79\ Vera-Llonch M, Oster G, Ford CM, Lu J, Sonis S. Oral
mucositis and outcomes of allogeneic hematopoietic stem-cell
transplantation in patients with hematologic malignancies. Support
Care Cancer May, 2007 15(5):491-496. [PubMed: 17139495].
\80\ Ruescher TJ, Sodeifi A, Scrivani SJ, Kaban LB, Sonis ST.
The impact of mucositis on alpha-hemolytic streptococcal infection
in patients undergoing autologous bone marrow transplantation for
hematologic malignancies. Cancer 1998;82(11):2275-2281. [PubMed:
9610710].
\81\ Mazzetti T, Sergio da Silva Santos P, Spindola Antunes H,
et al. Required time for pre-oncological dental management--A rapid
review of the literature. Oral Oncol. 2022 11;134:106116. doi:
https://dx.doi.org/10.1016/j.oraloncology.2022.106116. PMID:
36115328.
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Moreover, as described in section II.K.2. of this final rule,
dental services to identify and treat oral complications/comorbidities
prior to and, sometimes, throughout chemotherapy treatment have been
associated with improved outcomes for the patient receiving medical
services in the treatment of cancer.\82\ Additionally, as discussed in
section II.K.2. of this final rule, research studies support that
dental evaluation/treatment prior to cancer treatment led to decreased
incidence and/or less severity of serious oral infections and
complications (such as, oral mucositis and osteonecrosis) with the
medical services, as well as requiring fewer emergency
treatments.83 84
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\82\ Poulopoulos A, Papadopoulos P, Andreadis D. Chemotherapy:
oral side effects and dental interventions--a review of the
literature. Stomatological Disease and Science. 2017; 1:35-49.
http://dx.doi.org/10.20517/2573-0002.2017.03.
\83\ Watson EE, Metcalfe JE, Kreher MR, et al. Screening for
Dental Infections Achieves 6-Fold Reduction in Dental Emergencies
During Induction Chemotherapy for Acute Myeloid Leukemia. JCO Oncol
Pract. 2020 11;16(11):e1397-e405. doi: https://dx.doi.org/10.1200/OP.20.00107. PMID: 32609586.
\84\ Owosho AA, Liang STY, Sax AZ, et al. Medication-related
osteonecrosis of the jaw: An update on the memorial sloan kettering
cancer center experience and the role of premedication dental
evaluation in prevention. Oral Surg Oral Med Oral Pathol Oral
Radiol. 2018 May;125(5):440-5. doi: https://dx.doi.org/10.1016/j.oooo.2018.02.003. PMID: 29580668.
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Consequently, we believe that the evidence supports that the
standard of care is such that one would not proceed with the
chemotherapy when used in the treatment of cancer without performing
the dental services because the covered services would or could be
significantly and materially compromised, such that clinical outcomes
of the chemotherapy treatment could be compromised absent the provision
of the inextricably linked dental services.
As described in the CY 2023 PFS final rule (87 FR 69685), we noted
that evidence to support the linkage between the dental and covered
services could include information demonstrating that the standard of
care would be to not proceed with the covered medical procedure until a
dental or oral exam is performed to clear the patient of an oral or
dental infection; or, in instances where a known oral or dental
infection is present, the standard is such that the medical
professional would not proceed with the medical service until the
patient received the necessary treatment to eradicate the infection.
Our review of relevant clinical practice guidelines demonstrated that
multiple professional societies recommend the performance of dental
services prior to the initiation of or during
chemotherapy.85 86 For instance, the United Kingdom
published a guideline for dental evaluation and treatment before and
after treatments for head and neck cancer (5th edition of the UK Multi-
Disciplinary Guidelines for Head and Neck Cancer), based on guidance
from the National Institute for Health and Care Excellence (NICE) and
expert recommendations: ``Preventive oral care must be delivered to
patients whose cancer treatment will affect the oral cavity, jaws,
salivary glands and oral accessibility.'' \87\ Additionally, as
described in the CY 2023 PFS final rule (87 FR 69680), several
commenters provided data regarding the treatment of head and neck
cancer that illustrated that conditions such as oral mucositis or
osteonecrosis of the jaw that occur during the treatment may compromise
the clinical success of the primary medical service (chemotherapy for
the treatment of head and neck cancer), potentially leading to multiple
hospitalizations, including systemic infections or fatal sepsis, if
dental infections remained untreated.
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\85\ Butterworth C, McCaul L, Barclay C. Restorative dentistry
and oral rehabilitation: United Kingdom National Multidisciplinary
Guidelines. J Laryngol Otol. 2016 May;130(S2):S41-S4. PMID:
27841112.
\86\ American Academy of Pediatric Dentistry. Dental management
of pediatric patients receiving immunosuppressive therapy and/or
head and neck radiation. The Reference Manual of Pediatric
Dentistry. Chicago, Ill.; 2022:507-16.
\87\ Butterworth C, McCaul L, Barclay C. Restorative dentistry
and oral rehabilitation: United Kingdom National Multidisciplinary
Guidelines. J Laryngol Otol. 2016 May;130(S2):S41-S4. PMID:
27841112.
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We believe chemotherapy used in the treatment of cancer causes
acute immunosuppression, causing significant oral complications and
adverse events, including the possibility of an oral or dental
infection, which in turn may lead to serious and imminent risks to the
success of the primary medical procedures and treatments. These
treatment-induced complications, including possible infection, prevent
the ability to proceed with the primary, covered medical service (that
is, lead to delays in treatment and/or cause the inability of the
patient to complete the course of treatment, thereby potentially
reducing the effectiveness of the therapy) and the standard of care
would be to not proceed with the covered medical procedure until a
dental or oral exam is performed to address the oral complications and/
or clear the patient of an oral or dental infection. In the case of the
Medicare covered chemotherapy, when used in the treatment of cancer,
dental services serve to mitigate the likelihood of occurrence and
severity of complications caused by the primary medical services,
including infection, and consequently, the dental services facilitate
the successful completion of the prescribed course of treatment, and
therefore, the dental services are integral and inextricably linked to
these medical services, and the statutory dental exclusion would not
apply.
We believe that proceeding without a dental or oral exam and
necessary diagnosis and treatment of any presenting infection of the
mouth prior to chemotherapy when used in the treatment of cancer could
lead to systemic infection or sepsis, as well as other complications
for the patient. We also believe that an oral or dental infection could
present substantial risk to the success of chemotherapy when used in
the treatment of cancer, such that the standard of care would be to not
proceed with the procedure when there is a known oral or dental
infection present. We believe dental services furnished to identify,
diagnose, and treat oral or dental infections prior to and medically
necessary diagnostic and
[[Page 79020]]
treatment services to eliminate an oral or dental infection prior to,
or contemporaneously with chemotherapy when used in the treatment of
cancer are not in connection with the care, treatment, filling,
removal, or replacement of teeth or structures directly supporting
teeth, but instead are inextricably linked to these other covered
services.
In the CY 2024 PFS proposed rule, we also solicited comment on
whether we should consider radiation therapy in the treatment of cancer
more broadly (not in conjunction with chemotherapy, and not in relation
to head and neck cancer treatment) as medical services that may be
inextricably linked to dental services (88 FR 52377). We stated that we
do not believe that radiation therapy alone necessarily leads to the
same level of treatment-induced immunosuppression as for cancer
patients receiving chemotherapy since radiation specifically targets
malignant cells and has more targeted and localized effects on the body
as compared to system-wide immunosuppression effects of chemotherapy
for cancer treatment. However, we solicited comment on whether dental
services prior to radiation therapy in the treatment of cancer, when
furnished without chemotherapy, such as second line therapy for
metastasized cancer in the head and neck, would be inextricably linked
to the radiation therapy services, and therefore, payable under
Medicare Parts A and B.
We received public comments on this proposal. The following is a
summary of the comments we received and our responses.
Comment: Commenters supported the proposal that Medicare Parts A
and B payment may be made for dental services, such as dental or oral
examination performed as part of a comprehensive workup prior to, and
medically necessary diagnostic and treatment services to eliminate an
oral or dental infection prior to, or contemporaneously with Medicare-
covered chemotherapy when used in the treatment of cancer and urged CMS
to finalize this policy as proposed. Commenters included individuals,
patient advocacy organizations, hospitals and hospital associations,
medical and dental associations representing several different
specialties and specialty societies, health centers, and health
insurance companies, among others. Many commenters expressed the view
that payment for dental services in the proposed additional
circumstances could improve patient outcomes and quality of life and
reduce Medicare expenditures overall by avoiding the need to cover
medical complications arising from untreated dental conditions.
Commenters also stated that they believe that these updates will have a
direct and meaningful impact on the lives of many Medicare
beneficiaries. Many commenters also stated that they believe that these
revisions would serve to promote health equity and increase access to
medically necessary services for vulnerable members of the Medicare
population. The commenters asserted that underserved populations
generally do not have access to the necessary oral health services
required for successful outcomes and will help address persistent
inequities in cancer outcomes. Commenters also stated that they
believed payment for dental services in these circumstances may ensure
that poor oral health in these circumstances does not further
complicate the treatment of these covered medical conditions, may
generate cost savings for vulnerable patients, and may also help with
their candidacy for further interventions such as allogeneic stem cell
transplant.
Commenters stated that standard of care in many cancer centers
includes a comprehensive oral exam prior to starting therapy.\88\
Commenters also noted that the National Cancer Institute recommends
that cancer patients receiving high-dose chemotherapy, stem cell
transplants, or radiation therapy should have an oral care plan in
place before treatment begins to mitigate the risk of oral
complications \89\ that administering chemotherapy before providing
dental treatment when an identifiable oral or dental infection is
present does not align with the established standard of care.
Commenters also supported the proposed clarification that payment may
be made for dental and oral health treatments and ancillary services
prior to or during cancer treatment regardless of the cancer's primary
or metastatic status, site of origin, or initial treatment modality.
Several commenters expressed support and appreciation for proposing to
permit Medicare payment for dental services in scenarios where patients
are receiving chemotherapy as a single modality, regardless of whether
chemotherapy is used in combination with other cancer therapies.
Commenters noted that if the policy were to only apply in cases where
chemotherapy is the only treatment, they were concerned that such an
application of the policy would increase health disparities between
cancer treatments.
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\88\ Yong CW, Robinson A, Hong C. Dental Evaluation Prior to
Cancer Therapy. Front Oral Health. 2022 Apr 18;3:876941. doi:
10.3389/froh.2022.876941. PMID: 35510226; PMCID: PMC9058061.
\89\ https://www.cancer.gov/about-cancer/treatment/side-effects/mouth-throat/oral-complications-hp-pdq.
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Response: We agree with commenters that there is evidence to
support that certain dental services serve to mitigate the substantial
risk to the clinical success of the medical services due to the
severity of complications that can be caused by the dental infection.
We also agree that administering chemotherapy before providing dental
treatment when an identifiable oral or dental infection is present does
not align with the established standard of care, and that the dental
services are considered to be an essential clinical requirement before
moving forward with the primary medical procedure.
We further agree with commenters that Medicare payment for dental
services should not be limited to cases where chemotherapy in the
treatment of cancer is provided without the use of other therapies, as
chemotherapy services when used in the treatment of cancer, either as a
single modality or in conjunction with other therapy types, can cause
immunosuppression which may lead to significant oral complications and
adverse events, including the possibility of an oral or dental
infection, which in turn lead to serious and imminent risks to the
success of the primary medical procedures and treatments. The
complications, including possible infection, may prevent the ability to
both initiate and proceed with the primary, covered medical service
(that is, lead to delays in treatment and/or cause inability of the
patient to complete the course of treatment, thereby potentially
reducing effectiveness of the therapy) such that the standard of care
would be to not proceed with the covered medical procedure until a
dental or oral exam is performed to address the oral complications and/
or clear the patient of an oral or dental infection. In the case of
chemotherapy services when used in the treatment of cancer, dental
services serve to mitigate the likelihood of occurrence and severity of
complications caused by the primary medical services, including
infection, and consequently, the dental services facilitate the
successful completion of the prescribed course of treatment. As such,
we believe the dental services are integral and inextricably linked to
the chemotherapy when used in the treatment of cancer, and the
statutory dental exclusion under section 1862(a)(12) of the Act would
not apply
[[Page 79021]]
and are finalizing this aspect of the proposal.
Comment: Several commenters requested that Medicare provide payment
for dental and oral examinations performed as part of a comprehensive
workup for Medicare beneficiaries with cancer prior to the
administration of single modality radiation therapy, outside of usage
in the treatment of head and neck cancer. Commenters suggested that
radiation, although usually not systemic, also has a powerful cytotoxic
effect, though commenters noted that radiation may have a less damaging
impact on the immune system because it is not systemic and does not
cause immunosuppression. Commenters stated that radiation does have to
travel through areas of healthy cells to treat the tumor, so healthy
cells through which the radiation travels and nearby cells can be
affected. Commenters also stated that the radiation may directly damage
the immune system, the skeletal system, or bone marrow, causing
neutropenia. Commenters stated that, for example, radiation near the
axilla following treatment of a solid breast cancer tumor, can damage
lymph nodes which are part of the immune system, leading to risk of
infection in the arm and lymphedema.
Commenters further suggested that patients with a diagnosis of
leukemia, lymphoma, or multiple myeloma scheduled for a stem cell or,
bone marrow transplant receive total body radiation (TBI) prior to the
transplant (conditioning process), which then causes neutropenia and
related immunosuppression. The commenters noted that because the
radiation conditioning process kills stem cells, patients are
temporarily unable to replace the neutrophils that fight infection,
potentially leaving the patients at higher risk for oral and systemic
infections such as dental infections.
Response: We appreciate the suggestion that single modality
radiation therapy should be included in the list of covered medical
services. However, we do not believe that the evidence submitted by
commenters is sufficient to demonstrate an inextricable linkage between
dental services and the success of single modality radiation therapy
during the treatment of certain cancers (other than head and neck
cancer). In cases of single modality radiation (other than when
utilized for treatment of head and neck cancer), we are not convinced
that the radiation treatment necessary to treat the individual's
underlying medical condition requires the performance of certain dental
services and that those dental services would serve to mitigate the
substantial risk to the success of the medical services, due to the
occurrence and severity of complications caused by the primary medical
services. While single modality radiation may create medical
complications for the patient, we do not believe that dental services
would serve to mitigate the substantial risk to the success of the
radiation or is an essential clinical requirement before moving forward
with the primary medical procedure, and therefore, that an inextricable
linkage between the covered medical services and the provision of
dental services can be established. However, we note that in instances,
for example, where patients with a diagnosis of leukemia, lymphoma, or
multiple myeloma scheduled for a stem cell or, bone marrow transplant
receiving total body radiation (TBI) prior to the transplant
(conditioning process) pretreatment for transplantation, Medicare Parts
A and B payment may be made for dental services, such as dental or oral
examination performed as part of a comprehensive workup prior to, and
medically necessary diagnostic and treatment services to eliminate an
oral or dental infection prior to, or contemporaneously with, an organ
transplant, including hematopoietic stem cell transplant, are currently
included in the examples listed at Sec. 411.15(i)(3)(i).
However, we continue to encourage additional public discussions and
engagement on issues relating to Medicare payment for certain dental
services that do not fall within the exclusion under section
1862(a)(12) of the Act through the finalized public process as
described in section described in section II.K.1.c. above in this final
rule and welcome additional public submissions regarding single
modality radiation. We continue to seek medical evidence that certain
dental services are so integral to medically necessary services that
they are not in connection with the care, treatment, filling, removal,
or replacement of teeth or structures directly supporting teeth within
the meaning of section 1862(a)(12) of the Act and that such dental
services are inextricably linked to other covered services.
Moreover, we note that MACs retain the flexibility to determine on
a claim-by-claim basis whether a patient's circumstances do or do not
fit within the terms of the preclusion or exception specified in
section 1862(a)(12) of the Act and Sec. 411.15(i)(3). We further note
that the finalized policies outlined in this section of the final rule
would not prevent a MAC from making a determination that payment can be
made for dental services in accordance with the regulation at Sec.
411.15(i)(3)(i) in other circumstances not specifically addressed
within this final rule and the finalized amendments to that regulation.
After consideration of the public comments, clinical practice
guidelines, recommendations provided by the public, and our analyses of
the studies and research, we are finalizing amendments to our
regulation at Sec. 411.15(i)(3)(i) to add chemotherapy in the
treatment of cancer as an additional example of a clinical scenario
under which payment can be made under Medicare Parts A and B, under the
applicable payment system, for certain dental services that occur
within the inpatient hospital and outpatient setting, as clinically
appropriate. We are finalizing, with modifications, an amendment to
Sec. 411.15(i)(3)(i) to add dental or oral examination performed as
part of a comprehensive workup prior to, and medically necessary
diagnostic and treatment services to eliminate an oral or dental
infection prior to, or contemporaneously with, chemotherapy in the
treatment of cancer to the list of examples of dental services that are
not subject to the exclusion under section 1862(a)(12) of the Act and
for which payment can be made under Medicare Parts A and B for dental
services.
b. Dental Services Inextricably Linked to CAR T-Cell Therapy, When Used
in the Treatment of Cancer
After consideration of clinical practice guidelines,
recommendations provided by the public, and our analyses of the studies
and research available regarding the connection between dental services
and the clinical success of CAR T-cell therapy, in the CY 2024 PFS
proposed rule we proposed that dental services to diagnose and treat
infection prior to CAR T-cell therapy are inextricably linked to the
clinical success of CAR T-cell therapy, and that these services also
represent a clinically analogous scenario to dental services for which
Medicare payment under Parts A and B is currently permitted when
furnished in the inpatient or outpatient setting, such as prior to
organ transplant, cardiac valve replacement, or valvuloplasty
procedures (88 FR 52377 to 52379). We stated that we believe there is
an inextricable link between dental and CAR T-cell therapy when used in
the treatment of cancer because the standard of care is such that one
would not proceed with the medical procedure or service without
performing the dental service because the covered medical
[[Page 79022]]
services would or could be significantly and materially compromised
absent the provision of the inextricably-linked dental services and
that dental services are a clinical prerequisite to proceeding with the
CAR T-cell therapy when used in the treatment of cancer.
We believe that proceeding without a dental or oral exam and
necessary diagnosis and treatment of any presenting infection of the
mouth prior to (CAR) T-cell therapy when used in the treatment of
cancer could lead to systemic infection or sepsis, as well as other
complications for the patient. We also believe that an oral or dental
infection could present a substantial risk to the success of the (CAR)
T-cell therapy when used in the treatment of cancer, such that the
standard of care would be to not proceed with the procedure when there
is a known oral or dental infection present. We believe dental services
furnished to identify, diagnose, and treat oral or dental infections
prior to and medically necessary diagnostic and treatment services to
eliminate an oral or dental infection prior to, or contemporaneously
with (CAR) T-cell therapy when used in the treatment of cancer are not
in connection with the care, treatment, filling, removal, or
replacement of teeth or structures directly supporting teeth, but
instead are inextricably linked to these other covered medical
services. As such, in the CY 2024 PFS proposed rule, we proposed to add
this clinical scenario to the examples of clinical scenarios under
which payment can be made for certain dental services in our regulation
at Sec. 411.15(i)(3)(i)(A) (88 FR 52379). Specifically, we proposed to
amend the regulation to include a dental or oral examination performed
as part of a comprehensive workup in either the inpatient or outpatient
setting prior to Medicare-covered CAR T-cell therapy when used in the
treatment of cancer; and medically necessary diagnostic and treatment
services to eliminate an oral or dental infection prior to, or
contemporaneously with, CAR T-cell therapy when used in the treatment
of cancer. We solicited comments on all aspects of this proposal.
We also solicited comment on whether we should add as an example of
dental services for which payment may be made under Medicare Parts A
and B other types of lymphodepleting medical services used for cancer
treatment, in addition to those used in conjunction with CAR T-cell
therapy for cancer treatment. Commenters submitting through the public
process for consideration in CY 2024 rulemaking specifically stated
that CAR T-Cell therapies constituted lymphodepleting therapies, and we
believe there may be other immunotherapies that may have a similar
lymphodepletion component, but we received no specific information
regarding such therapies. Evidence submitted by the public through the
finalized public submission process indicates that treatment-induced
immunosuppression may also occur with lymphodepleting medical services,
and that complications caused by the treatment-induced
immunosuppression, including possible infection, may prevent the
ability to proceed with the primary, covered medical service (that is,
lead to delays in treatment and/or cause inability of the patient to
complete the course of treatment, thereby potentially reducing the
effectiveness of the therapy) and the standard of care would be to not
proceed with the covered medical procedure until a dental or oral exam
is performed to address the oral complications and/or clear the patient
of an oral or dental infection. However, we requested comment on what
specific medical services also involve lymphodepletion and should be
considered in addition to CAR T-cell therapy. We also requested
additional information regarding how dental infections/conditions might
impact those specific services. We noted that if we receive compelling
clinical evidence, we may finalize in the CY 2024 PFS final rule
additional clinical scenarios, such as dental services prior to other
types of specific lymphodepleting medical services where the treatment
may induce immunosuppression for patients with cancer and the standard
of care would be to not proceed with the medical services without
having first complete the dental services, where payment could be made
under Medicare Part A or Part B. We solicited comment on whether there
is a significant quality of care detriment if certain dental services
are not provided prior to these other types of lymphodepleting medical
services, and if so, we requested a description of that systematic
evidence. We received public comments on this proposal. The following
is a summary of the comments we received and our responses.
Comment: Commenters supported the proposal that Medicare Parts A
and B payment may be made for dental services, such as dental or oral
examination performed as part of a comprehensive workup prior to, and
medically necessary diagnostic and treatment services to eliminate an
oral or dental infection prior to, or contemporaneously with Medicare-
covered CAR-T cell therapies when used in the treatment of cancer and
urged CMS to finalize this policy as proposed. Commenters included
individuals, patient advocacy organizations, hospitals and hospital
associations, medical and dental associations representing several
different specialties and specialty societies, health centers, and
health insurance companies, among others.
Many commenters expressed that payment for dental services in the
proposed additional circumstances could improve patient outcomes and
quality of life and reduce Medicare expenditures overall by avoiding
the need to cover medical complications arising from untreated dental
conditions. Commenters also stated that they believe that these updates
will have a direct and meaningful impact on the lives of many of
Medicare beneficiaries. Many commenters also stated that they believe
that these revisions would serve to promote health equity and increase
access to medically necessary services for vulnerable members of the
Medicare population. The commenters asserted that underserved
populations generally do not have access to the necessary oral health
services required for successful outcomes and will help address
persistent inequities in cancer outcomes. Commenters also stated that
they believed payment for dental services in these circumstances may
ensure that poor oral health in these circumstances does not further
complicate the treatment of these covered medical conditions, may
generate cost savings for vulnerable patients, and may also help with
their candidacy for further interventions such as allogeneic stem cell
transplant.
Commenters stated that standard care in many cancer centers
includes a comprehensive oral exam, which is a requirement prior to
starting CAR T-cell therapy. Commenters noted that proceeding with CAR
T-cell prior to dental treatment services when a known oral or dental
infection is present is not the accepted standard of care, as the
presence of the infection could jeopardize the outcome of the
treatment. Commenters further stated that CAR T-cell medical services
cause a patient to be immunosuppressed, such that an untreated oral or
dental infection could complicate or compromise the clinical outcome of
the CAR T-cell medical service. For those reasons, the commenters
supported CMS' proposal and urged finalization of the proposed policy.
[[Page 79023]]
Response: We agree with commenters that there is evidence to
support that dental services serve to mitigate the substantial risk to
the success of the medical services due to the severity of
complications caused by the primary medical services, including
increased risk of infection and potential sepsis. We also agree that
the standard of care for chemotherapy, when used in the treatment of
cancer, would be compromised absent the provision of certain dental
services and that the dental services are considered to be an essential
clinical requirement before moving forward with the primary medical
procedure.
Additionally, we agree with commenters that CAR T-cell therapy
causes immunosuppression, which may lead to significant oral
complications and adverse events, including the possibility of an oral
or dental infection, which in turn leads to serious and imminent risks
to the success of the primary medical procedures and treatments. The
complications, including possible infection, may prevent the ability to
both initiate and proceed with the primary, covered medical service
(that is, lead to delays in treatment and/or cause inability of the
patient to complete the course of treatment, thereby potentially
reducing effectiveness of the therapy) such that the standard of care
would be to not proceed with the covered medical procedure until a
dental or oral exam is performed to address the oral complications and/
or clear the patient of an oral or dental infection. In the case of CAR
T-cell therapy services when used in the treatment of cancer, dental
services serve to mitigate the likelihood of occurrence and severity of
complications caused by the primary medical services, including
infection, and consequently the dental services facilitate the
successful completion of the prescribed course of treatment. Therefore,
we believe that the dental services that are inextricably linked to,
and substantially related and integral to the clinical success of, CAR
T-cell in the treatment of cancer are not subject to the exclusion
under section 1862(a)(12) of the Act and that payment can be made under
Medicare Parts A and B, under the applicable payment system, for such
dental services that occur within the inpatient hospital and outpatient
setting, as clinically appropriate. We are finalizing, with
modifications, an amendment to Sec. 411.15(i)(3)(i) to add dental or
oral examination performed as part of a comprehensive workup prior to,
and medically necessary diagnostic and treatment services to eliminate
an oral or dental infection prior to, or contemporaneously with CAR T-
cell therapy in the treatment of cancer to the list of examples of
services that are not subject to the exclusion under section
1862(a)(12) of the Act and for which payment can be made under Medicare
Parts A and B. We are finalizing this aspect of the proposal.
Comment: A few commenters provided feedback and requested that CMS
evaluate whether dental services may be inextricably linked to the
clinical success of other immunotherapies that may have a similar
lymphodepleting component as CAR T-cell therapies. However, the
commenters noted that at this time they were unable to supply medical
or clinical evidence to support this potential addition to this policy.
The commenters encouraged CMS to continue to consider whether dental
services may be inextricably linked to the clinical success of other
immunotherapies that may have a similar lymphodepleting component as
CAR T-cell therapies. One commenter submitted research related to the
usage of rituximab as a first-line treatment for non-Hodgkin's lymphoma
and discussed the impacts the advent of rituximab had on treatment
outcomes for patients with diffuse large B cell lymphoma (DLBCL)
compared with the pre-rituximab era.\90\
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\90\ Mohammed R, Milne A, Kayani K, Ojha U. How the discovery of
rituximab impacted the treatment of B-cell non-Hodgkin's lymphomas.
J Blood Med. 2019 Feb 27;10:71-84. doi: 10.2147/JBM.S190784. PMID:
30881167; PMCID: PMC6398399.
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Response: We thank the commenters for their suggestion and
submission of studies related to the connection between the clinical
success of other immunotherapies that may have a lymphodepleting
component and the provision of dental services. While the clinical
trials appeared to show a positive impact of rituximab on survival
outcomes when treating aggressive B-cell lymphomas, the research did
not provide concrete evidence regarding the connection between the
provision of dental or oral services and outcomes for immunotherapies
such as Rituximab. We continue to welcome further evidence on the
impact of dental services on clinical scenarios involving monoclonal
antibodies. Additionally, while some commenters noted that there is
limited evidence to establish that dental services may be inextricably
linked to the clinical success of other lymphodepleting therapies, we
will continue to consider this and other suggestions as we consider
potential future rulemaking through research of clinical studies and
related materials. We reiterate that as described in section II.K.1.c.
of this final rule, documentation submitted for the purposes of this
payment policy should include medical evidence to support that certain
dental services are inextricably linked to other covered services.
Materials submitted should demonstrate that dental services are so
integral to other medically necessary services that they are not in
connection with the care, treatment, filling, removal, or replacement
of teeth or structures directly supporting teeth within the meaning of
section 1862(a)(12) of the Act but rather that such dental services are
inextricably linked to other covered services, and therefore, are
instead substantially related and integral to that primary medical
service. Details regarding the public submission process are available
in the CY 2023 PFS final rule (87 FR 69669 through 69670).
Moreover, we reiterate that MACs have the flexibility to determine
on a claim-by-claim basis whether certain dental services for
beneficiaries receiving other immunotherapies that may involve a
lymphodepleting component are subject to the exclusion on payment for
dental services under section 1862(a)(12) of the Act and Sec.
411.15(i). We further note that the finalized policies outlined in this
section of this final rule would not prevent a MAC from determining on
a case-by-case basis that payment can be made for certain dental
services in other circumstances not specifically addressed within this
final rule and Sec. 411.15(i)(3)(i), including as that regulation is
amended by this final rule.
c. Dental Services Inextricably Linked to Administration of High-Dose
Bone-Modifying Agents (Antiresorptive Therapy) When Used in the
Treatment of Cancer
In the CY 2024 PFS proposed rule, after consideration of clinical
practice guidelines, recommendations provided by the public, and our
analyses of the studies and research available regarding the connection
between dental services and the clinical success of the administration
of high-dose bone-modifying agents (antiresorptive therapy) when used
in the treatment of cancer, we proposed to add this clinical scenario
to the examples of clinical scenarios under which payment can be made
for certain dental services in our regulation at Sec.
411.15(i)(3)(i)(A) (88 FR 52379). We stated that we believe that there
is an inextricable link between dental and administration of high-dose
bone-modifying agents (antiresorptive
[[Page 79024]]
therapy) when used in the treatment of cancer because the standard of
care is such that one would not proceed with the medical procedure or
service without performing the dental service because the covered
medical services would or could be significantly and materially
compromised absent the provision of the inextricably-linked dental
services and that dental services are a clinical prerequisite to
proceeding with the administration of high-dose bone-modifying agents
(antiresorptive therapy) when used in the treatment of cancer.
Specifically, we proposed to amend the regulation to include dental or
oral examination performed as part of a comprehensive workup in either
the inpatient or outpatient setting prior to Medicare-covered the
administration of Medicare-covered high-dose bone-modifying agents
(antiresorptive therapy), when used in the treatment of cancer; and
medically necessary diagnostic and treatment services to eliminate an
oral or dental infection prior to, or contemporaneously with,
administration of high-dose bone-modifying agents (antiresorptive
therapy), when used in the treatment of cancer. We solicited comments
on all aspects of this proposal.
We note that in the CY 2023 PFS final rule (87 FR 70225) and now
codified in our regulation at Sec. 411.15(i)(3)(i), we finalized that
for dental services that are inextricably linked to, and substantially
related and integral to the clinical success of, a certain covered
medical service, payment may be made under Medicare Parts A and B for
services when furnished in either the inpatient or outpatient setting;
therefore, we proposed that these provisions would apply to the
proposed amendments to regulation at Sec. 411.15(i)(3)(i) to allow for
payment under Medicare Parts A and Part B in either the inpatient or
outpatient setting. We further proposed that payment under the
applicable payment system could also be made for services that are
ancillary to these dental services, such as x-rays, administration of
anesthesia, and use of the operating room as described in our
regulation at Sec. 411.15(i)(3)(ii).
We received public comments on this proposal. The following is a
summary of the comments we received and our responses.
Comment: Commenters supported Medicare payment for dental services,
such as dental or oral examination performed as part of a comprehensive
workup prior to, and medically necessary diagnostic and treatment
services to eliminate an oral or dental infection prior to, or
contemporaneously with the administration of high-dose bone-modifying
agents (antiresorptive therapy) when used in the treatment of cancer.
Commenters included individuals, patient advocacy organizations,
hospitals and hospital associations, medical and dental associations
representing several different specialties and specialty societies,
health centers, and health insurance companies, among others. Many
commenters expressed the view that payment for dental services in the
proposed additional circumstances could improve patient outcomes and
quality of life and reduce Medicare expenditures overall by avoiding
the need to cover medical complications arising from untreated dental
conditions. Commenters also stated that they believe that these updates
will have a direct and meaningful impact on the lives of many of
Medicare beneficiaries. Many commenters also stated that they believe
that these revisions would serve to promote health equity and increase
access to medically necessary services for vulnerable members of the
Medicare population. The commenters asserted that underserved
populations generally do not have access to the necessary oral health
services required for successful outcomes and will help address
persistent inequities in cancer outcomes. Commenters also stated that
they believed payment for dental services in these circumstances may
ensure that poor oral health in these circumstances does not further
complicate the treatment of these covered medical conditions and may
generate cost savings for vulnerable patients.
Commenters recommended that Medicare provide payment for dental
exams and related preventative services before initiating bone directed
therapy using bisphosphonates and denosumab and urged CMS to finalize
this policy as proposed. Commenters noted that there is no effective
treatment for bisphosphonate-induced osteonecrosis, but preventative
dental exams and management decrease risk of osteonecrosis of the jaw
in cancer patients receiving these therapies, which can in turn
jeopardize the successful completion of the treatment for cancer.
Commenters stated that research shows that osteonecrosis of the jaw is
a preventable condition, and that care coordination and preventative
services can result in improved outcomes and in lower incidence of
osteonecrosis of the jaw for cancer patients receiving bisphosphonate
therapy. Commenters expressed appreciation for the inclusion of
clinical guidelines as the rationale for coverage in the proposed rule,
which state that cancer patients should receive an oral care assessment
(including a comprehensive dental, periodontal, and oral radiographic
exam, when feasible) prior to initiating the administration of high-
dose bone modifying agents (antiresorptive therapy) when used in the
treatment of cancer to reduce complications and manage modifiable risk
factors. Commenters stated that the dental-related complication to
certain immunosuppressive cancer treatments, such as high-dose
antiresorptive and/or antiangiogenic drug therapy can be serious,
particularly medication-related osteonecrosis of the jaw (MRONJ), which
can complicate cancer treatment and lead to reduced survival rates
post-treatment. Commenters noted that patients with existing dental
disease pose the greatest risk for developing MRONJ secondary to bone-
modifying therapy and recommended that the dental infection be
addressed prior to the start of care, so as to facilitate the
successful completion of the treatment. Commenters further stated that
from a clinical standpoint, prevention of MRONJ is the gold standard
and emphasized the importance of a multidisciplinary, coordinated
approach that includes pretreatment dental management in minimizing the
risk of MRONJ and supported CMS's proposal to expand Medicare coverage
and payment for dental examinations prior to, as well as diagnostic and
treatment services to eliminate an oral or dental infection prior to or
at the same time as, the administration of high-dose bone modifying
agents.
Response: We agree with commenters that there is evidence to
support that dental services serve to mitigate the substantial risk to
the success of the medical services due to the severity of
complications caused by the primary medical services as well as
minimize the risk of infection and therefore the dental services are so
integral to other medically necessary services that they are not in
connection with the care, treatment, filling, removal, or replacement
of teeth or structures directly supporting teeth within the meaning of
section 1862(a)(12) of the Act. Rather, such dental services are
inextricably linked to the clinical success of the medical service and
are substantially related and integral to the covered medical service
of administration of high-dose bone modifying agents in the treatment
of cancer. As such, we are finalizing our proposal that Medicare Part A
and Part B payment can be made for certain
[[Page 79025]]
dental services such as dental or oral examination performed as part of
a comprehensive workup prior to, and medically necessary diagnostic and
treatment services to eliminate an oral or dental infection prior to,
or contemporaneously with, the administration of high-dose bone-
modifying agents (antiresorptive therapy) when used in the treatment of
cancer. We believe that the standard of care for that medical service
would be compromised absent the provision of dental services, and that
the dental services are considered to be an essential clinical
requirement before moving forward with the primary medical procedure.
Comment: A few commenters asked that we clarify the term ``high-
dose'' bisphosphonate therapy and provide guidance regarding what this
phrase means so as to minimize potential confusion with respect to this
policy.
Response: For the purposes of Medicare payment for dental services
inextricably linked to other covered services, the term ``high-dose''
bisphosphonate therapy refers to the usage of bisphosphonate therapy
when used in the treatment of cancer. In general, for patients
undergoing treatment for cancer, currently, intravenous formulations
have FDA label indication for patients with multiple myeloma or bone
metastases from solid tumors. We believe that the particular dosage may
be adjusted for various clinical situations, so setting a defined high-
dose dosage at a particular level may inadvertently exclude certain
patient populations (such as renal-impaired patients who are receiving
a particular dose). We also recognize that there may also be variation
in dosage interval for the bisphosphonates varying between three, four,
and perhaps twelve weeks of therapy. As such, we believe that ``high-
dose'' bisphosphonate therapy to which dental care may be inextricably
linked would be defined as intravenous bisphosphonate therapy for the
treatment of multiple myeloma and bone metastases of solid tumors. For
example, ICD-10 codes for related conditions could include those that
reflect multiple myeloma and bone metastases from a primary solid tumor
(for example, breast, prostate), such as C90 Multiple myeloma and
malignant plasma cell neoplasms, C90.0 Multiple myeloma, C90.00
Multiple myeloma not having achieved remission, C90.01 Multiple myeloma
in remission, C90.02 Multiple myeloma in relapse, C79.5 Secondary
malignant neoplasm of bone and bone marrow, C79.51 Secondary malignant
neoplasm of bone or C79.52 Secondary malignant neoplasm of bone marrow.
From the evidence provided and reviewed, we note there are FDA
approved defined intravenous dosages and intervals (with adjustment for
renal impairment) for the use of some bisphosphonates for metastatic
bone lesions and multiple myeloma, and we would not expect that oral
regimens of these or other bisphosphonates would be commonly prescribed
for these purposes.91 92 However, other dosage forms, when
used for these purposes, possibly in an off-label manner, could be
considered by the MACs on a case-by-case basis. Additionally, we would
be open to reviewing evidence in the future of other applicable dosage
forms. Currently, oral regimens have indications for osteoporosis and
Paget's disease, which are not included in the list of clinical
examples at Sec. 411.15(i).
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\91\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021113s008lbl.pdf.
\92\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021223s028lbl.pdf.
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After consideration of the public comments, clinical practice
guidelines, recommendations provided by the public, and our analyses of
the studies and research, we are finalizing amendments to our
regulation at Sec. 411.15(i)(3)(i) to provide that dental services
that are inextricably linked to, and substantially related and integral
to the clinical success of, the administration of high-dose bone-
modifying agents (antiresorptive therapy) in the treatment of cancer
are not subject to the exclusion under section 1862(a)(12) of the Act;
and that payment can be made under Medicare Parts A and B, under the
applicable payment system, for such dental services that occur within
the inpatient hospital and outpatient setting, as clinically
appropriate. We are also finalizing an amendment to Sec.
411.15(i)(3)(i) to add dental or oral examination performed as part of
a comprehensive workup prior to, and medically necessary diagnostic and
treatment services to eliminate an oral or dental infection prior to,
or contemporaneously with the administration of high-dose bone-
modifying agents (antiresorptive therapy) in the treatment of cancer to
the list of examples of services that are not subject to the exclusion
under section 1862(a)(12) of the Act and for which payment can be made
under Medicare Parts A and B.
d. Amendments to Regulations Regarding Dental Services Inextricably
Linked to Treatment for Head and Neck Cancer
In the CY 2024 PFS proposed rule, we proposed to clarify and codify
that Medicare Parts A and B payment may be made for dental or oral
examination performed as part of a comprehensive workup in either the
inpatient or outpatient setting, as well as for the medically necessary
diagnostic and treatment services to eliminate an oral or dental
infection prior to the initiation of, or during, treatments for head
and neck cancer, whether primary or metastatic, regardless of site of
origin, and regardless of initial modality of treatment (88 FR 52380).
Specifically, we proposed to amend our regulation at Sec.
411.15(i)(3)(i)(A) to allow for payment under Medicare Parts A and Part
B for:
(1) Dental or oral examination in either the inpatient or
outpatient setting prior to the initiation of, or during, Medicare-
covered treatments for head and neck cancer; and
(2) Medically necessary diagnostic and treatment services to
eliminate an oral or dental infection in either the inpatient or
outpatient setting prior to the initiation of, or during, Medicare-
covered treatments for head and neck cancer.
We received public comments on this proposal. The following is a
summary of the comments we received and our responses.
Comment: Commenters supported Medicare payment for dental services,
such as dental or oral examination performed as part of a comprehensive
workup prior to, and medically necessary diagnostic and treatment
services to eliminate an oral or dental infection prior to, or
contemporaneously with treatments for head and neck cancers. Commenters
included individuals, patient advocacy organizations, hospitals and
hospital associations, medical and dental associations representing
several different specialties and specialty societies, health centers,
and health insurance companies, among others. Many commenters expressed
the view that payment for dental services in the proposed additional
circumstances could improve patient outcomes and quality of life and
reduce Medicare expenditures overall by avoiding the need to cover
medical complications arising from untreated dental conditions.
Commenters also stated that they believe that these updates will have a
direct and meaningful impact on the lives of many of Medicare
[[Page 79026]]
beneficiaries. Many commenters also stated that they believe that these
revisions would serve to promote health equity and increase access to
medically necessary services for vulnerable members of the Medicare
population. The commenters asserted that underserved populations
generally do not have access to the necessary oral health services
required for successful outcomes and will help address persistent
inequities in cancer outcomes. Commenters also stated that they
believed payment for dental services in these circumstances may ensure
that poor oral health in these circumstances does not further
complicate the treatment of these covered medical conditions and may
generate cost savings for vulnerable patients.
Commenters described that treatment for head and neck cancer
generally refers to a group of cancers that originate in or metastasize
to various areas of the head and neck, with the mucosal surfaces of the
oral cavity, pharynx and larynx being most common and stated that these
cancers are often grouped together because they share common risk
factors, symptoms, and treatment approaches.
Commenters noted, particularly for patients undergoing radiation
therapy for any head and neck cancer, the importance of thorough
initial dental evaluation, including dental x-rays, with special
attention to any teeth that may require timely procedures, such as root
canals and extractions, prior to radiation therapy. The commenters
stated that cleaning and preparation work for radiation therapy is
critical to the clinical success of radiation therapy. Commenters
provided evidence that described the connection between the provision
of dental services prior to, during, and after the treatment for head
and neck cancer and the reduction of risk of complications that may
jeopardize the success of the treatments and simultaneously result in
improved outcomes for the patient.
Response: We thank the commenters for their support. We agree that
head and neck cancer generally refers to a group of cancers that
originate in or metastasize to areas of the head and neck, which could
include the mucosal surfaces of the oral cavity, pharynx and larynx and
acknowledge that these cancers are often grouped together because they
share common risk factors, symptoms, and treatment approaches. We also
agree that the medical services necessary to diagnose and treat the
underlying head and neck cancer may require the performance of certain
dental services, which in turn serve to mitigate the substantial risk
to the success of the medical services because of the risk of infection
and of the occurrence and severity of complications that are caused by
the primary medical services. Additionally, we agree that the standard
of care for treatment for head and neck cancer would be compromised
absent the performance of certain dental services, and that dental
services are considered to be an essential clinical requirement before
moving forward with the primary medical procedure. As such, we are
finalizing our proposal that Medicare Part A and Part B payment can be
made for certain dental services when furnished prior to or
contemporaneously with the treatment of head and neck cancer.
Comment: Several commenters requested that Medicare payment be
permitted for patients undergoing single modality radiation therapy for
any head and neck cancer, as the commenters note that it is important
that those patients receive a thorough initial dental evaluation,
including dental x-rays, with special attention to any teeth that may
require timely procedures, such as root canals and extractions, prior
to radiation therapy. Commenters provided evidence and stated that
cleaning and preparation work for radiation therapy is also critical to
the clinical success of radiation therapy, including the preparation of
a fluoride carrier to protect teeth in an ongoing fashion. Commenters
supplied research and further stated that due to the chronic dental
side effects of head and neck radiotherapy and the risk of
osteoradionecrosis with dental extractions after treatment, curative
treatment for the underlying cancer may be delayed until dental care
can be completed and that those delays would be eliminated if dental
care could be addressed prior to the initiation of radiation treatment.
Commenters also noted that in some radiation oncology treatments, masks
utilized for treatment must fit on patients' faces correctly when
receiving radiology and suggested that if the mask fits improperly due
to issues related to dental care, treatment for the underly cancer is
delayed until dental care can be completed. Commenters asserted that
dental care to address these issues would facilitate the successful
completion of the radiology treatment for head and neck cancer.
Response: We agree that in the case of head and neck cancers,
single modality radiation therapy uniquely impacts the dental and oral
tissues such that the provision of certain dental services before or
during the single modality treatment are linked to improved outcomes,
including the reduction of the risk of infection. As such, we are
finalizing our proposal that Medicare Part A and Part B payment can be
made for certain dental services furnished before or during single
modality radiation therapy when used in the treatment of head and neck
cancer even when used as the single treatment modality and not in
combination with any other therapy types.
Comment: Many commenters requested that Medicare payment be
permitted after direct treatment is completed for patients undergoing
treatment for head and neck cancer. The commenters suggested that
dental evaluations to identify, address, and rectify potential oral
complications are necessary to ensure the success of the treatments and
to improve quality outcomes for the patient in the period after the
direct treatment for head and neck cancer. Commenters supplied clinical
studies and research that demonstrate that the side effects encountered
by patients undergoing treatment, such as radiotherapy, chemotherapy or
combination treatment with concurrent systemic agents, for head and
neck cancers, can include, but are not limited to: infection,
mucositis, hyposalivation, dysphagia, osteoradionecrosis, and
radiation-related caries.93 94 95 96 97 98 99
[[Page 79027]]
Commenters noted that these oral toxicities may be acute (developing
during active treatment) or late onset (manifesting several months
after treatment is complete) with some latent complications of
radiotherapy linked to permanent tissue damage, as well as damage to
bony structures, tissues, and salivary glands. Commenters noted that
current data show approximately 30 percent of head and neck cancer
patients develop radiation caries within 12 months following completion
of radiotherapy.\100\
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\93\ National Cancer Institute. Head and Neck Cancers. Updated
May 25, 2021. Available at https://www.cancer.gov/types/head-and-neck/head-neck-fact-sheet Accessed August 8, 2023.
\94\ Pisani, P., Airoldi, M., Allais, A., Aluffi Valletti, P.,
Battista, M., Benazzo, M., Briatore, R., Cacciola, S., Cocuzza, S.,
Colombo, A., Conti, B., Costanzo, A., Della Vecchia, L., Denaro, N.,
Fantozzi, C., Galizia, D., Garzaro, M., Genta, I., Iasi, G. A.,
Krengli, M., Landolfo, V., Lanza, G.V., Magnano, M., Mancuso, M.,
Maroldi, R., Masini, L., Merlano, M.C., Piemonte, M., Pisani, S.,
Prina-Mello, A., Prioglio, L., Rugiu, M.G., Scasso, F., Serra, A.,
Valente, G., Zannetti, M., and Zigliani, A. (2020). Metastatic
disease in head & neck oncology. Acta Otorhinolaryngologica
Italica,40(SUPPL. 1), S1-S86. https://doi.org/10.14639/0392-100X-suppl.1-40-2020.
\95\ Pisani, P., Airoldi, M., Allais, A., Aluffi Valletti, P.,
Battista, M., Benazzo, M., Briatore, R., Cacciola, S., Cocuzza, S.,
Colombo, A., Conti, B., Costanzo, A., Della Vecchia, L., Denaro, N.,
Fantozzi, C., Galizia, D., Garzaro, M., Genta, I., Iasi, G. A.,
Krengli, M., Landolfo, V., Lanza, G.V., Magnano, M., Mancuso, M.,
Maroldi, R., Masini, L., Merlano, M.C., Piemonte, M., Pisani, S.,
Prina-Mello, A., Prioglio, L., Rugiu, M.G., Scasso, F., Serra, A.,
Valente, G., Zannetti, M., and Zigliani, A. (2020). Metastatic
disease in head & neck oncology. Acta Otorhinolaryngologica
Italica,40(SUPPL. 1), S1-S86. https://doi.org/10.14639/0392-100X-suppl.1402020.
\96\ Epstein, J.B., Thariat, J., Bensadoun, R.J., Barasch, A.,
Murphy, B.A., Kolnick, L., Popplewell, L. and Maghami, E. (2021).
Oral complications of cancer and cancer therapy. CA: Cancer Journal
for Clinicians, 62(6). 400-422. https://doi.org/10.3322/caac.21157.
\97\ Palmier N.R., Ribeiro, A.C.P, Fonseca, J.M., Salvajoli,
J.C., Vargas, P.A., Lopes, M.A., Brandao, T.B. and Santos-Silva,
A.R. (2017). Radiation-related caries assessment through the
International Caries Detection and Assessment System and the Post-
Radiation Dental Index. Oral Surgery Oral Medicine Oral Pathology
Oral Radiology, 124(6), 542-7. https://doi.org/10.1016/j.oooo.2017.08.019.
\98\ National Institute for Dental and Craniofacial Research.
(2009). Oral Complications of Dental Treatment: What the Dental Team
Can Do (NIH Publication No. 09-4372). National Institutes of Health.
2023. https://www.nidcr.nih.gov/sites/default/files/2017-09/oral-complications-cancerdental-team.pdf. Accessed August 11, 2023.
\99\ PDQ[supreg] Supportive and Palliative Care Editorial Board.
PDQ Oral Complications of Chemotherapy and Head/Neck Radiation.
Bethesda, MD: National Cancer Institute. Updated October 21, 2022.
Available at https://www.cancer.gov/about-cancer/treatment/side-effects/mouth-throat/oralcomplications-hp-pdq. Accessed August 11,
2023. [PMID: 26389320].
\100\ Pedroso, C.M., Miglioratti, C.A., Epstein, J.B., Ribeiro,
A.C.P., Brandao, T.B., Lopes, M.A., Fernando de Goes, M. and Santos-
Silva, A.R. (2022). Over 300 radiation caries papers: Reflections
from the rearview mirror. Frontiers in Oral Health, 3. https://doi.org/10.3389/froh.2022.961594.
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Commenters also stated that the oral health of cancer patients
undergoing radiation therapy in the treatment of head and neck cancer
are uniquely impacted by the primary medical services intended to treat
the underlying cancer. Commenters stated that patients undergoing
radiotherapy experience an overall deterioration of dental and
periodontal health, as well as chronic effects of radiotherapy, such as
mucosal pain and recurrent infection, salivary gland dysfunction, and
osteoradionecrosis, all of which are caused by the primary treatments
for cancer. Commenters noted that these oral complications caused by
the treatment for head and neck cancer can be either acute or chronic
and can manifest within months of the final treatments and potentially
persist through the end of life. Commenters stated that managing oral
complications of head and neck cancer therapy can be very costly and
create a financial burden for patients, offering that ongoing treatment
for complications caused by treatment can range from approximately
$4,000-$35,000 for osteoradionecrosis and between $5,000-$30,000 for
management of oral mucositis in cancer patients undergoing
radiotherapy, stating that some researchers attribute this high cost
both to the resource-intensive settings in which management of oral
complications typically takes place and the complex needs of cancer
patients including enteral and parenteral feedings, febrile
neutropenia, and frequency of hospitalizations.101 102
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\101\ Sroussi, H.Y., Epstein, J.B., Bensdoun, R.J., Saunders,
D.P., Lalla, R.V., Migliorati, C.A., Heaivilin, N. and Zumsteg, Z.S.
(2017). Common oral complications of head and neck cancer radiation
therapy: mucositis, infections, saliva change, fibrosis, sensory
dysfunctions, dental caries, periodontal disease, and
osteoradionecrosis. Cancer Medicine,6(12). 298-2931. https://doi.org/10.1002/cam4.1221.
\102\ Elting, L.S. and Chang, Y.C. (2019). Costs or oral
complications of cancer therapies: Estimates and a blueprint for
future study. Journal of the National Cancer Institute
Monographs,2019(53). https://doi.org/10.1093/jncimonographs/lgz010.
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Additional commenters stated that, in general, medical standards of
cancer care include routine follow-up, supplemental, or secondary
treatments for symptom management and long-term management of overall
health for head and neck cancer patients, and that oral and dental care
should be incorporated into clinical cancer care protocols for pre-,
intra- and post-treatment, especially for diagnoses or therapies known
to cause oral complications. The commenters asserted that access to
medically necessary dental services post-radiation positively impact
patient quality of life and mitigate some of the resource-intensive
treatment of advanced oral sequelae of head and neck cancer and its
treatment. These commenters requested that CMS expand Medicare payment
to include medically necessary dental services occurring
postradiotherapy for beneficiaries with a diagnosis of head and neck
cancer.
Several commenters asked CMS to adopt a definition of ``during'' or
``contemporaneously with'' in the treatment of head and neck cancer
that recognizes the patient-specific clinical decisions that occur in
this specific patient population. The commenters suggested that the
definition of ``during'' or ``contemporaneously with'' for head and
neck cancer should encompass a clinically recognized recovery phase for
targeted head and neck cancer treatment, which the commenters noted
they believe would advance the goals of the Medicare program without
violating the statutory dental exclusion.
Response: We appreciate the commenters' thoughtful and evidence-
based feedback regarding the link between medically necessary
diagnostic and treatment services for head and neck cancer and the
unique circumstances surrounding the ongoing oral complications that
following treatment for head and neck cancer. While we did not propose
to add to our regulation that Medicare Parts A and B payment is
permitted for medically necessary diagnostic and treatment services to
address dental or oral complications after radiation, chemotherapy,
and/or surgery when used in the treatment of head and neck cancer, we
are persuaded by evidence provided by commenters that treatment for
head and neck cancer uniquely causes additional significant and acute
(developing during active treatment) dental and/or oral complications
for the patient, including increased risk of infection even after the
direct treatment for head and neck cancer has ended. The research
submitted by commenters indicates that radiation therapy causes an
increased occurrence of caries, mucositis, osteoradionecrosis, and
other severe complications. Commenters provided persuasive arguments,
clinical guidelines, and research to substantiate that the provision of
dental services with the treatment for head and neck cancer leads to
improved healing and improved quality outcomes for the treatments,
including the reduction of incidence of infection, and without the
provision of dental services, the final outcome of the treatment for
head and neck cancer may be jeopardized. We are also convinced that the
standard of care for the treatments for head and neck cancer would be
compromised absent the provision of dental services to address the oral
complications caused by the primary treatment. Additionally, we are
convinced by the evidence submitted by commenters that the provision of
certain dental services after direct treatments for head and neck
cancers supports that certain dental services would result in
clinically significant improvements in quality and safety outcomes for
the patient.
The research submitted by commenters demonstrates varying post-
treatment dental needs for individuals receiving treatment for head and
neck cancer (HNC), stemming from the acute (developing during active
treatment) and chronic complications caused by the treatment for the
HNC. For example, mucositis may be caused by either radiation therapy
or chemotherapy. According to the National Cancer Institute, mucositis
caused by chemotherapy will heal by itself, usually within 2 to 4 weeks
if there is no infection. Mucositis caused by radiation therapy usually
lasts 6 to 8 weeks, depending on the duration of
[[Page 79028]]
treatment.\103\ Additionally, complications such as dropped head
syndrome (DHS) can occur from 3 months to 30 years after radiation
therapy for HNC patients.\104\ Current research highlights the long-
term dental service needs for individuals treated for HNC. Patients who
underwent radiation therapy reported oral complications and challenges
within six months after treatment, such as dry mouth, sticky saliva,
difficulty swallowing solid foods, and changes in taste.\105\ A
systematic review revealed that certain treatment-related issues
persisted beyond 12 months, including dry mouth, sticky saliva,
difficulties with social eating, fatigue, and physical
functioning,\106\ all of which may benefit from ongoing monitoring and
dental support in the first year following treatment and beyond.
Moreover, access to expert oral healthcare is critical for both HNC
patients and survivors, as issues related to mobility and sensory
disturbances can persist permanently.\107\ A systematic review
indicated that dental caries occurs in approximately 29 percent of
post-radiotherapy HNC patients. Furthermore, the risk of developing
dental caries within two years of head and neck radiotherapy is
approximately 37 percent; studies with a higher proportion of patients
treated with chemotherapy, in addition to radiotherapy, had an
increased incidence of dental caries.\108\ Based on the evidence
provided by commenters, we believe that most oral complications may
arise within 24 months of the completion of direct treatment. However,
we recognize that some oral complications may persist beyond such a
window. We continue to seek feedback from the public and interested
parties on our continued interest in understanding how the timing of
medical treatment and oral health care might illustrate an inextricable
linkage.
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\103\ PDQ[supreg] Supportive and Palliative Care Editorial
Board. PDQ Oral Complications of Chemotherapy and Head/Neck
Radiation. Bethesda, MD: National Cancer Institute. Updated <04/26/
2019>. Available at https://www.cancer.gov/about-cancer/treatment/side-effects/mouth-throat/oral-complications-pdq. Accessed 10/12/
2023. [PMID: 26389169]
\104\ Brook I. Late side effects of radiation treatment for head
and neck cancer. Radiat Oncol J. 2020 Jun;38(2):84-92. doi: 10.3857/
roj.2020.00213. Epub 2020 Jun 25. PMID: 33012151; PMCID: PMC7533405.
\105\ Lalla RV, Treister N, Sollecito T, Schmidt B, Patton LL,
Mohammadi K, Hodges JS, Brennan MT; OraRad Study Group. Oral
complications at 6 months after radiation therapy for head and neck
cancer. Oral Dis. 2017 Nov;23(8):1134-1143. doi: 10.1111/odi.12710.
Epub 2017 Aug 3. PMID: 28675770; PMCID: PMC6218933.
\106\ So WK, Chan RJ, Chan DN, Hughes BG, Chair SY, Choi KC,
Chan CW. Quality-of-life among head and neck cancer survivors at one
year after treatment--a systematic review. Eur J Cancer. 2012
Oct;48(15):2391-408. doi: 10.1016/j.ejca.2012.04.005. Epub 2012 May
12. PMID: 22579456.
\107\ Sroussi HY, Epstein JB, Bensadoun RJ, Saunders DP, Lalla
RV, Migliorati CA, Heaivilin N, Zumsteg ZS. Common oral
complications of head and neck cancer radiation therapy: mucositis,
infections, saliva change, fibrosis, sensory dysfunctions, dental
caries, periodontal disease, and osteoradionecrosis. Cancer Med.
2017 Dec;6(12):2918-2931. doi: 10.1002/cam4.1221. Epub 2017 Oct 25.
PMID: 29071801; PMCID: PMC5727249.
\108\ Moore C, McLister C, Cardwell C, O'Neill C, Donnelly M,
McKenna G. Dental caries following radiotherapy for head and neck
cancer: A systematic review. Oral Oncol. 2020 Jan;100:104484. doi:
10.1016/j.oraloncology.2019.104484. Epub 2019 Nov 28. PMID:
31786391.
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For example, we believe that dental services may be warranted in
the case of a patient with locoregionally advanced head and neck
cancers treated with surgery followed by radiation therapy, or
definitive radiation therapy, with or without adjuvant chemotherapy,
and the oral cavity is within the radiation treatment field. We
considered the clinical scenario of a 75-year-old patient who is a non-
smoker, that presents with a single enlarged 2 cm level 2 [upper
lateral neck] right lymph node. The ensuing work-up discovers human
papilloma virus (HPV) positive squamous cell carcinoma in the neck node
with a right base of tongue primary tumor. The patient has intact
dentition. The patient is treated with definitive chemoradiation for
both the primary tumor and the regional metastatic neck disease. The
patient is followed regularly by the dentist during and after treatment
to assist with management of the oral mucositis and xerostomia [dry
mouth] and to monitor the dentition. The oral services provided after
the direct treatment for head and neck cancer serve to address any
complications that may arise from the primary treatment itself. In this
scenario, we believe that Medicare Parts A and B payment may be made
for dental services inextricably linked to the treatment for head and
neck cancer, such as dental or oral examination to monitor for oral and
dental complications such as oral mucositis and xerostomia, as well as
evaluate for changes in dentition and identification and the
elimination of an oral or dental infection. We note that additional
dental services, such as a dental implant or crown, may not be
considered immediately necessary to address oral complications caused
by the treatment for head and neck cancer. Therefore, we believe that
such additional services would not be inextricably linked to, and
substantially related and integral to, the clinical success of, the
treatment for head and neck cancer. As such, no Medicare payment would
be made for the additional services that are not immediately necessary
prior to addressing the oral complications caused by the treatments for
head and neck cancer.
We also considered another case in which a 65-year-old patient, who
is a long-term smoker, presents with multiple level 2 and 3 [upper and
mid lateral neck] enlarged left lymph nodes. The ensuing work-up
discovers human papilloma virus (HPV) negative squamous cell carcinoma
in the neck nodes, but no defined primary origin of tumor, and no
distant metastases. The patient has generally poor dentition and
undergoes extraction of several vulnerable teeth by an oral surgeon
prior to beginning the cancer treatment. The patient is treated with a
left modified radical neck dissection [surgery to remove the cancerous
lymph nodes in the neck with some of the surrounding tissue] followed
by radiation therapy to the neck and the aerodigestive mucosa [nose,
mouth and throat lining] from the nasopharynx [back of the nose] to the
larynx [voice box]. The patient declined adjuvant chemotherapy. The
patient is followed by the dentist during and after treatment to assist
with management of the oral mucositis and xerostomia [dry mouth] and to
monitor the remaining dentition. Again, the oral services provided
after the direct treatment for head and neck cancer serve to address
the unique oral complications that were a result of the primary
treatment itself. In this scenario, we believe that Medicare Parts A
and B payment may be made for dental services inextricably linked to
the treatment for head and neck cancer, such as medically necessary
diagnostic and treatment services to eliminate an oral or dental
infection prior to the initiation of treatment, and, after direct
treatment, dental or oral examination to monitor for oral and dental
complications such as oral mucositis and xerostomia, as well as
evaluate for changes in dentition and identification and the
elimination of an oral or dental infection resulting from the treatment
for head and neck cancers. We note that additional dental services,
such as a dental implant or crown, may not be considered immediately
necessary to address oral complications caused by the treatment for
head and neck cancer. Therefore, we believe that such additional
services would not be inextricably linked to, and substantially related
and integral to the clinical success of, the treatment for head and
neck cancer. As such, no Medicare
[[Page 79029]]
payment would be made for the additional services that are not
immediately necessary prior to address the oral complications caused by
the treatments for head and neck cancer.
As described by evidence submitted by the commenters, the treatment
of head and neck cancer causes oral complications caused by the primary
medical treatment itself and increases the risk of infection after the
direct treatment. Treatments for head and neck cancers are demonstrated
to cause infection, caries, mucositis, and osteoradionecrosis, among
other complications and jeopardize successful outcomes for the
treatments. We are convinced that the provision of dental services in
the context of treatments for head and neck cancers for the
complications of the medical treatment is inextricably linked to the
primary medical treatment. This is not only because such services lead
to improved healing and improved quality outcomes, and because without
the provision of dental services, the final outcome of the treatment
for head and neck cancer may be jeopardized, but especially because the
treatment itself is the direct cause of the acute oral/dental
complications requiring the dental intervention. As demonstrated by
evidence submitted by commenters, these complications may occur after
some passage of time following the primary medical treatment. In other
words, the treatment of head and neck cancer directly causes the oral
complications, which may emerge after the treatment is completed.
Treatments for head and neck cancers may cause infection, caries,
mucositis, and osteoradionecrosis, among other complications, that may
occur over months post-treatment. Based on persuasive information
presented by commenters, we believe addressing and rectifying these
direct consequences of the primary medical treatment for head and neck
cancer aligns with the standard of care for treatment of head and neck
cancers, would result in improved clinical outcomes for the patient,
and is inextricably linked to the treatment.
Therefore, we believe that there is a direct connection between the
primary treatment and the dental and oral complications caused by the
treatment for head and neck cancer itself, including those that occur
after the direct treatments for cancer. As such, we believe that these
dental services should be considered not subject to the general
preclusion on payment for dental services under section 1862(a)(12) of
the Act because they are inextricably linked to, and substantially
related and integral to the clinical success of, the treatment for head
and neck cancer, because the dental services serve to mitigate the
substantial risk to the success of the medical services due to the
severity of complications caused by the primary medical services and
the standard of care for the medical service would be compromised.
Consequently, we are clarifying that for the purposes of treatment for
head and neck cancer, treatment may include dental services required in
the period following direct treatment for the head and neck cancer.
Final Action Statement
As described in the sections above, we are revising Sec.
411.15(i)(3)(i) to add to the list of clinical scenarios under which
Medicare Part A and B payment is permitted for dental or oral
examinations performed as part of a comprehensive workup prior to, and
medically necessary diagnostic and treatment services to eliminate an
oral or dental infection prior to, or contemporaneously with, the
following Medicare-covered services: chemotherapy, chimeric antigen
receptor (CAR) T-cell therapy, and the administration of high-dose
bone-modifying agents (antiresorptive therapy) when used in the
treatment of cancer. We are also adding a new Sec. 411.15(i)(3)(i)(E)
to permit Part A and B payment for dental or oral examination performed
as part of a comprehensive workup prior to, medically necessary
diagnostic and treatment services to eliminate an oral or dental
infection prior to, or contemporaneously with, and medically necessary
diagnostic and treatment services to address dental or oral
complications after, radiation, chemotherapy, and/or surgery when used
in the treatment of head and neck cancer. The policies we are
finalizing take into account commenters' feedback and information
provided in clinical literature, such as peer reviewed publications or
clinical guidelines supported by clinical evidence, supporting the
inextricable link between dental services and certain covered medical
services. We anticipate making conforming changes to the Medicare
Benefit Policy Manual (IOM Pub. 100-02) to reflect the final changes.
Additionally, we intend to issue educational and outreach materials to
inform billing and payment for any policies finalized in the final
rule. Moreover, we believe that the process we finalized for CY 2023,
as described above in section II.K.1.c. of this final rule, to engage
with interested parties and review their recommendations regarding the
inextricable link between dental services and certain covered medical
services will continue to serve the need expressed by commenters for
continued engagement on these issues. Additionally, we intend to
continue to engage in discussions with the public on a wide spectrum of
issues relating to Medicare payment for certain dental services that do
not fall within the preclusion or exclusion under section 1862(a)(12)
of the Act and related topics. We also continue to partner with
researchers at the Agency for Healthcare Research and Quality (AHRQ)
and other entities to consider and study the relationship between
dental services and specific covered medical services, to review
available clinical evidence regarding the relationship between dental
services and specific covered medical services, and to identify other
potential instances in which dental services are inextricably linked to
other covered services. Furthermore, we remain open to adjusting and
revising these finalized policies through future rulemaking and/or
additional guidance as necessary. We appreciate the thoughtful
questions raised by commenters and remain committed to continued
engagement.
3. Dental Services Integral to Covered Cardiac Interventions
In the CY 2023 PFS final rule, we finalized a policy to permit
payment for dental or oral examination performed as part of a
comprehensive workup in either the inpatient or outpatient setting
prior to Medicare-covered cardiac valve replacement or valvuloplasty
procedures; and medically necessary diagnostic and treatment services
to eliminate an oral or dental infection prior to, or contemporaneously
with, the cardiac valve replacement or valvuloplasty procedure (87 FR
69675).
We recognized that, without a dental or oral exam and necessary
diagnosis and treatment of any presenting infection of the mouth prior
to a cardiac valve replacement or valvuloplasty procedure, an
undetected, non-eradicated oral or dental infection could lead to
bacteria seeding the valves and the surrounding cardiac muscle tissues
involved with the surgical site and conceivably leading to systemic
infection or sepsis, all of which increase the likelihood of
unnecessary and preventable acute and chronic complications for the
patient (87 FR 69667).\109\ Specifically, we noted that the replaced
valve is also at risk of being a seeding source for future
endocarditis.
[[Page 79030]]
Endocarditis can carry a high risk of mortality for these patients and
eliminating an infection prior to or contemporaneously with the
procedure would be important for preventing future endocarditis related
to the new valve (87 FR 69678).
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\109\ Knox, K.W., & Hunter, N. (1991). The role of oral bacteria
in the pathogenesis of infective endocarditis. Australian dental
journal, 36(4), 286-292. https://doi.org/10.1111/j.1834-7819.1991.tb00724.x.
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We also concluded that an oral or dental infection could present a
substantial risk to the success of organ transplants, such that the
standard of care would be to not proceed with the procedure when there
is a known oral or dental infection present. We stated that we believe
dental services furnished to identify, diagnose, and treat oral or
dental infections prior to organ transplant, cardiac valve replacement,
or valvuloplasty procedures are not in connection with the care,
treatment, filling, removal, or replacement of teeth or structures
directly supporting teeth, but instead are inextricably linked to these
other covered medical services (89 FR 69667).
We encouraged the public to use the public submission process
finalized in the CY 2023 PFS final rule to identify additional clinical
scenarios and related medical evidence to support an inextricable link
between specified dental services and other covered medical services.
Through the submission process, an interested party has encouraged
CMS to consider extending Medicare payment to include dental services
to eliminate infection prior to all cardiovascular procedures, as the
mitigation of risks of perioperative and postoperative infection and
complications is critical to ensure optimal surgical outcomes for all
patients requiring invasive and/or interventional cardiac procedures.
This submission noted that the current standard of care does not
conclusively require dental evaluation, diagnosis, or treatment
services prior to certain cardiac procedures, perhaps in part because
such cardiac procedures are often performed on a more urgent or
emergent basis where there is not an opportunity to consider the
possible presence of dental infection. Moreover, the submission noted
that much of the scientific literature is inconclusive as to whether
pre-operative dental treatments impact postoperative surgical outcomes
in cardiovascular surgery, including cardiac valve procedures.\110\ A
systematic literature review by Cotti et al. found that, based upon
expert opinion, there is general agreement on the need for screening
and treatment of oral/dental infections in patients who are to undergo
cardiac surgery (although no standardized clinical guidelines or
protocols exist to outline the screening process, in terms of either
dental treatment options and/or timing of such procedures in relation
to the planned cardiac intervention).\111\ The authors convened an
expert panel from six Italian scientific societies (including
cardiologists, cardiac surgeons, and dental specialists) to establish a
consensus on early screening and resolution of dental or periodontal
infections prior to cardiac surgery, that they intended would result in
a standardized protocol for evaluating oral infections and dental
treatments for cardiac patients to be used in the interventional
preparation phase by both dental and cardiac teams.\112\ The authors
noted, however, the lack of scientific evidence on the risk-to-benefit
ratio for perioperative dental treatment in patients undergoing
cardiovascular surgery.
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\110\ Lockhart, P.B., DeLong, H.R., Lipman, R.D., Estrich, C.G.,
Araujo, M.W.B. and Carrasco-Labra, A. (2019). Effect of dental
treatment before cardiac valve surgery: Systematic review and meta-
analysis. Journal of the American Dental Association,150(9). 739-
747. https://doi.org/10.1016/j.adaj.2019.04.024.
\111\ Cotti, E., Cairo, F., Bassareo, P.P., Fonzar, F., Venturi,
M., Landi, L., Parolari, A., Franco, V., Fabiani, C., Barili, F., Di
Lenarda, A., Gulizia, M., Borzi, M., Campus, G., Musumeci, F., and
Mercuro, G. (2019). Perioperative dental screening and treatment in
patients undergoing cardiothoracic surgery and interventional
cardiovascular procedures. A consensus report based on RAND/UCLA
methodology. International Endodontic Journal,53. 186-199. https://doi.org/10.1111/iej.13166.
\112\ Ibid.
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We believe, after further review of current medical practice,
through consultations with interested parties (including commenters on
last year's final rule and those commenting on current topics) and our
medical officers, and through evidence submitted through the public
submission process we established in the CY 2023 PFS final rule, that
there may be additional circumstances that are clinically similar to
examples we codified in our regulation at Sec. 411.15(i)(3)(i) where
Medicare payment for dental services could be made under other clinical
circumstances where the dental services are inextricably linked to a
covered cardiac medical service(s).
To gain further understanding of any potential relationship between
dental services and specific covered cardiac medical services, we again
partnered with researchers at the AHRQ to review available clinical
evidence regarding the relationship between dental services and covered
cardiac medical services, including implantation of ventricular assist
devices, artificial pacemakers, implantable defibrillators, synthetic
vascular grafts and patches, and coronary and vascular stents. This
AHRQ report \113\ is available at https://effectivehealthcare.ahrq.gov/sites/default/files/related_files/rapid-response-cardio-dental.pdf.
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\113\ Hickam DH, Gordon CJ, Armstrong CE, Paynter R. The
Efficacy of Dental Services for Reducing Adverse Events in Those
Undergoing Insertion of Implantable Cardiovascular Devices. Rapid
Response. (Prepared by the Scientific Resource Center under Contract
No. 75Q80122C00002.) AHRQ Publication No. 23-EHC020. Rockville, MD:
Agency for Healthcare Research and Quality; June 2023. DOI: https://doi.org/10.23970/AHRQEPCRAPIDDENTALCARDIO.
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As stated in their report, the available evidence does not permit
conclusions regarding the effect of pre-treatment dental care for
preventing downstream infections related to any of these devices. They
noted that professional society guidelines endorse the provision of
patient education on routine oral hygiene practices but have not
recommended other pre-treatment dental care prior to insertion of these
devices. They also noted that professional society guidelines recommend
ongoing routine dental examinations for some patients treated with
cardiovascular devices.
Nonetheless we solicited comment to identify additional cardiac
interventions (that is, specific medical services) where the risk of
infection posed to beneficiaries is similar to that associated with
cardiac valve replacement or valvuloplasty. We note that, in order to
consider whether certain dental services are inextricably linked to
other covered services, we need to identify specific medical services
for which there is clinical evidence that certain dental services are
so integral to the clinical success that they are inextricably linked
to other covered service(s). We encourage interested parties to use the
public submission process to submit recommendations and relevant
clinical evidence for establishing this connection. In section II.K. of
this final rule, we have described the various types of documentation
to support recommendations through this process. We considered, and
solicited comment on, whether the following cardiac interventions are
examples of specific medical services for which dental services are
inextricably linked to clinical success: implantation of electronic
devices in the heart, such as pacemakers, cardioverter defibrillators,
and monitors. We also considered, and solicited comment on, whether the
following procedures would be considered examples of specific medical
services for which dental services are inextricably linked to their
clinical success: the placement of intracardiac or
[[Page 79031]]
intravascular foreign material, such as a stent or for hemodialysis, or
for a vascular access graft, whereas you would not proceed with the
medical service without having first completed a dental evaluation and/
or treatment as determined necessary. We solicited comment on whether
preoperative and perioperative dental services are inextricably linked
to any other covered cardiac interventions as supported by clinical
evidence.
We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: Some commenters urged us to permit payment for dental
screenings and, when clinically justified, medically necessary dental
treatment that a patient may need in order to undergo, or to avoid
complicating or compromising certain covered cardiac procedures, that
is, pacemaker insertion or replacement, insertion or replacement of
implantable cardioverter defibrillator, transcatheter aortic valve
replacement, aortic valve surgical procedure, mitral valve replacement,
endovascular stent repair or replacement, cardiac assist procedures,
and other cardiac valve procedures. These commenters asserted that a
large number of epidemiological investigations describe an association
between periodontal disease (PD) and cardiovascular diseases (CVD).
They reasoned that as CVD is clearly influenced by inflammation, and as
treatment of PD would reduce both oral and systemic inflammation, it is
logical to assume that treatment of PD would reduce overall
inflammatory burden and hence the risk of CVD. As such they drew a
parallel with our payment policy finalized last year for cardiac valve
replacement and valvuloplasty where they stated the risk of infection
posed to beneficiaries is similar. Other commenters stated that dental
services should be covered for interventional cardiovascular
procedures, another for device closure of intracardiac defects and
stent implants, other commenters stated generally that dental services
should be covered for cardiovascular disease patients, one commenter
wrote to say they were not opposed to coverage of dental services to
find and eradicate infection prior to the additional cardiac procedures
about which we requested information.
Response: As we described above, based on clinical evidence for
cardiac valve replacement and valvuloplasty, we believed that without a
dental or oral exam and necessary diagnosis and treatment of any
presenting infection of the mouth prior to or contemporaneous with the
procedure, an undetected, non-eradicated oral or dental infection could
lead to bacteria seeding the valves and the surrounding cardiac muscle
tissues involved with the surgical site and conceivably leading to
systemic infection or sepsis, all of which increase the likelihood of
unnecessary and preventable acute and chronic complications for the
patient. Commenters did not assert an inextricable linkage between
dental services and any covered cardiovascular service. They did cite
studies for the proposition that CVD and stroke are influenced by
inflammation and that as treatment of periodontal disease would reduce
both oral and systemic inflammation, then it is logical to assume that
treatment of periodontal disease would reduce overall inflammatory
burden and hence the risk of cardiovascular disease and ischemic
stroke. One study cited suggested that there may be associations
between periodontal disease and cardiovascular issues.\114\ Another
study cited found that periodontitis treatment can improve surrogate
measurements of cardiovascular health.\115\ Commenters did not offer
clinical evidence to support that dentally sourced infections can cause
serious complications at the site of intracardiac or intravascular
stents and devices, or that dental services to eradicate such dentally
sourced infections is so integral to clinical success of the
intracardiac or intravascular stents and devices that they are
inextricably linked.
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\114\ Peruzzi M, Covi K, Saccucci M, Pingitore A, Saade W,
Sciarra L, Cristalli MP, Miraldi F, Frati G, Cavarretta E. Current
knowledge on the association between cardiovascular and periodontal
disease: an umbrella review. Minerva Cardiol Angiol. 2022 Mar 25.
doi: 10.23736/S2724-5683.22.06022-7. Epub ahead of print. PMID:
35332749.
\115\ Sanz M, Del Castillo AM, Jepsen S, Gonzalez-Juanatey JR,
D'Aiuto F, Bouchard P, Chapple I, Dietrich T, Gotsman I, Graziani F,
Herrera D, Loos B, Madianos P, Michel JB, Perel P, Pieske B, Shapira
L, Shechter M, Tonetti M, Vlachopoulos C, Wimmer G. Periodontitis
and Cardiovascular Diseases. Consensus Report. Glob Heart. 2020 Feb
3;15(1):1. doi: 10.5334/gh.400. PMID: 32489774; PMCID: PMC7218770.
---------------------------------------------------------------------------
Comment: One commenter stated that most clinical guidelines do not
recommend prophylactic dental procedures before undergoing subsequent
cardiovascular procedures or device implantations. In contrast, the
commenter continued, other guidelines counsel the value of optimal oral
health hygiene and antibiotic prophylaxis to avoid infective
endocarditis in patients with congenital heart disease and/or prior
prosthetic valve implant. They summarized that current evidence might
not support a role for pre-treatment dental care for preventing
downstream infections related to the implantation of ventricular assist
devices, artificial pacemakers, implantable cardioverter
defibrillators, synthetic grafts, and patches, or coronary and vascular
stents. However, the commenters noted that as evidence and guidelines
continue to evolve--especially as increasing emphasis is placed on both
health equity and high-quality outcomes that conserve scarce health
care resources--it may prove appropriate for CMS to determine dental
services are inextricably linked to certain cardiovascular therapies in
the future.
Response: We will continue to monitor the evolution of guidelines
and the production of evidence showing specific cardiovascular services
for which dental services are inextricably linked to their clinical
success.
Comment: Another commenter stated that they do not believe that
dental evaluation and treatment are absolutely necessary prior to
performing stents and vascular access grafts for hemodialysis. They
relayed that clinicians report that while completing dental care before
such a procedure is a laudable goal, they would proceed with placing
the stent or graft without having this completed and do not believe
dental services are inextricably linked to the procedures.
Response: We thank the commenter for their perspective and sharing
of clinical insight. After consideration of public comments, we are not
expanding the examples in the regulation at Sec. 411.14(i)(3)(i) to
include additional cardiac procedures at this time but will continue to
consider public submissions through the public process discussed above
in section II.K.1.c. of the final rule, of specific medical services in
the future. Submissions should include clinical evidence that certain
dental services are so integral to their clinical success that the
standard of care for that cardiovascular intervention would be
compromised or require the dental services to be performed in
conjunction with the covered cardiovascular intervention services.
4. Request for Comment on Dental Services Integral to Specific Covered
Services To Treat Sickle Cell Disease (SCD) and Hemophilia
Payment for Dental Services for Individuals Living With SCD
Interested parties using the public submission process we finalized
in the CY 2023 PFS final rule urged us to propose to provide that
payment can be made for dental services for individuals living with
SCD.
These submissions provided information and references supporting
[[Page 79032]]
prevention of dental infection among individuals with SCD to reduce
need for more extensive procedures that may result in bleeding
complications and require hospitalization. They also provided
information detailing increased dental caries and periodontal disease
in people with SCD,\116\ many of whom lose a number of teeth, which
greatly limits nutrition, general well-being, and overall quality of
life.
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\116\ Kakkar M, Holderle K, ShethM, Arany S, Schiff L, Planerova
A. Orofacial Manifestation and Dental Management of Sickle Cell
Disease: A Scoping Review. Anemia. 2021 Oct22; 2021:5556708. Doi:
10.1155/2021/5556708. PMID: 34721900; PMCID: PMC8556080.
---------------------------------------------------------------------------
We note that the decisions we make through the public submissions
and the rulemaking process regarding whether payment is permitted for
certain dental services are not in terms of a coverage decision.
Rather, we are considering whether payment can be made for certain
dental services in a particular clinical scenario because, in
accordance with Sec. 411.15(i)(3)(i), the dental services would be
``inextricably linked to, and substantially related and integral to the
clinical success of a certain covered medical service'' such that they
are not subject to the statutory preclusion on payment for most dental
services under section 1862(a)(12). If we determine that certain dental
services provided in a specific clinical scenario do meet the criterion
in Sec. 411.15(i)(3)(i), then payment can be made for the dental
services.
We solicited comment on whether certain dental services are
inextricably linked to other covered services used in the treatment of
SCD, such as, but not limited to, hydroxyurea therapy. We solicited
comment identifying such covered services for SCD and whether an
inextricable link is supported by clinical evidence as described in
section II.K.1.c. of this final rule.
We received public comments on these requests for comment. The
following is a summary of the comments we received and our responses.
Comment: Several commenters supported coverage for dental services
as inextricably linked to covered services used in the treatment of
SCD, such as, but not limited to, hydroxyurea therapy. The commenters
also recommended that we extend coverage for dental services to
patients living with SCD or hemophilia for 2024. Other commenters urged
us to add SCD as a covered indication for treatment of dental services
that are integral to the outcomes for Medicare beneficiaries with SCD.
Another commenter urged us to expand coverage and payment of dental
services for individuals with SCD presenting with pain crises in the
jaw, mouth, or face and in the case of a dental abscess stated that
better access to dental services will help to improve quality of life
for individuals with SCD and reduce overall costs to the healthcare
system by allowing for more appropriate treatment options and a
reduction in length of hospital stay. This commenter provided
references.117 118 119 120 121 One commenter questioned the
clinical basis for adding SCD, and hemophilia, as predicates for
medically necessary dental benefits since there are relatively few
cases of SCD and hemophilia in the Medicare population.
---------------------------------------------------------------------------
\117\ Basati MS. Sickle cell disease and pulpal necrosis: a
review of the literature for the primary care dentist. Prim Dent J.
2014 Feb;3(1):76-9. doi:10.1308/205016814812135922.
\118\ Chekroun M, Ch[eacute]rifi H, Fournier B, Gaultier F,
Sitbon IY, Ferr[eacute] FC, Gogly B. Oral manifestations of sickle
cell disease. Br Dent J. 2019 Jan 11;226(1):27-31. doi: 10.1038/
sj.bdj.2019.4.
\119\ Hsu LL, Fan-Hsu J. Evidence-based dental management in the
new era of sickle cell disease: A scoping review. J Am Dent Assoc.
2020 Sep;151(9):668-677.e9. doi: 10.1016/j.adaj.2020.05.023.
\120\ Bedrouni M, Touma L, Sauv[eacute] C, Botez S,
Souli[egrave]res D, Fort[eacute] S. Numb Chin Syndrome in Sickle
Cell Disease: A Systematic Review and Recommendations for
Investigation and Management. Diagnostics (Basel). 2022 Nov
24;12(12):2933. doi:10.3390/diagnostics12122933.
\121\ Mestoudjian P, Steichen O, Stankovic K, Lecomte I, Lionnet
F. Sickle cell disease, a benign cause of numb chin syndrome. Am J
Med. 2008 Oct;121(10):e1. doi: 10.1016/j.amjmed.2008.05.028.
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Response: We thank commenters for their feedback. After
consideration of public comments, we are not expanding the examples
under Sec. 411.15(i)(3)(i) to include additional covered medical
services for SCD or hemophilia at this time but will continue to
consider public submissions through the public process discussed above
at section II.K.1.c. of the final rule, of specific medical services in
the future. The information commenters provided did not support finding
that dental services are inextricably linked to a covered medical
service for SCD or that the standard of SCD care would be compromised
or require dental services to be performed in conjunction with
hydroxyurea therapy or other treatment for SCD. One reference cited
concluded in part that good access to oral health care might be as
important for SCD as it is for diabetes mellitus, but more research is
needed.\122\ In order for us to find that dental services are
inextricably linked to, and substantially related and integral to the
clinical success of hydroxyurea therapy or other treatments for SCD, we
would need clinical evidence to demonstrate that the standard of care
would be not to proceed with the other covered services without
providing the dental services in conjunction with the hydroxyurea
therapy or other treatment for SCD. We welcome additional public
submissions by the February 10 deadline for consideration in PFS
rulemaking for CY 2025. Submissions should include medical evidence and
supporting literature addressing why dental services are inextricably
linked to hydroxyurea therapy or other covered treatment for SCD.
Specifically, we request that the medical evidence should support the
inextricable link between certain dental services and other covered
services by providing any of the following:
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\122\ Hsu LL, Fan-Hsu J. Evidence-based dental management in the
new era of sickle cell disease: A scoping review. J Am Dent Assoc.
2020 Sep;151(9):668-677.e9. doi: 10.1016/j.adaj.2020.05.023.
---------------------------------------------------------------------------
(1) Relevant peer-reviewed medical literature and research/studies
regarding the medical scenarios requiring medically necessary dental
care;
(2) Evidence of clinical guidelines or generally accepted standards
of care for the suggested clinical scenario; and/or
(3) Other supporting documentation to justify the inclusion of the
proposed medical clinical scenario requiring dental services (87 FR
69686, 69687).
Payment for Dental Services for Individuals Living With Hemophilia
Interested parties also urged us to propose a policy to permit
payment for dental services for individuals living with hemophilia.
They noted that periodic dental care reduces the risks of dental
complications requiring haemostatic therapy (such as tooth extractions
that may require clotting factor treatment) or oral surgeries requiring
clotting factor replacement therapy.123 124 125
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\123\ Raso S, Napolitano M, Sirocchi D, Siragusa S, Hermans C.
The important impact of dental care on haemostatic treatment burden
in patients with mild haemophilia. Haemophilia. 2022 Nov;28(6):996-
999. doi: 10.1111/hae.14626. Epub 2022 Jul 25. PMID: 35879819.
\124\ Srivastava A, Santagostino E, Dougall A, Kitchen S,
Sutherland M, Pipe SW, Carcao M, Mahlangu J, Ragni MV, Windyga J,
Llin[aacute]s A, Goddard NJ, Mohan R, Poonnoose PM, Feldman BM,
Lewis SZ, van den Berg HM, Pierce GF; WFH Guidelines for the
Management of Hemophilia panelists and co-authors. WFH Guidelines
for the Management of Hemophilia, 3rd edition. Haemophilia. 2020
Aug;26 Suppl 6:1-158. doi: 10.1111/hae.14046. Epub 2020 Aug 3.
Erratum in: Haemophilia. 2021 Jul;27(4):699. PMID: 32744769.
\125\ Peisker A, Raschke GF, Schultze-Mosgau S. Management of
dental extraction in patients with Haemophilia A and B: a report of
58 extractions. Med Oral Patol Oral Cir Bucal. 2014 Jan 1;19(1):e55-
60. doi: 10.4317/medoral.19191. PMID: 24121912; PMCID: PMC3909433.
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We noted that many submitters, using the public submission process
we
[[Page 79033]]
finalized in the CY 2023 PFS final rule, stated that good dental and
oral health benefits a patient's overall health generally. Several
commenters on the CY 2023 PFS proposed rule also expressed that good
oral hygiene, along with routine dental services, contributes to better
outcomes for patients. We recognized in the CY 2023 PFS final rule in
response to those comments that there is a great deal of evidence
suggesting that dental health is generally an important component of
overall health; however, we are interested in comments on whether
certain dental services are considered so integral to the primary
covered services that the necessary dental interventions are
inextricably linked to, and substantially related and integral to
clinical success of, the primary covered services such that they are
not subject to the statutory preclusion on Medicare payment for dental
services under section 1862(a)(12) of the Act.
We received public comments on these requests for comment. The
following is a summary of the comments we received and our responses.
Comment: One commenter urged us to permit payment under Medicare
Part A and Part B for preventive dental services for individuals with
hemophilia. They noted that Hemophilia Treatment Centers (HTCs) are a
federally supported network of care, and that the Centers for Disease
Control and Prevention (CDC) lists dentists as a specialist who should
be available by referral by an HTC and find it appropriate that the
Medicare would provide coverage and payment for these services. They
also reference World Federation of Hemophilia (WFH) Guidelines for the
Management of Hemophilia. These guidelines provide that maintaining
good oral health and preventing dental problems is greatly important in
the prevention of oral diseases and conditions such as gingivitis,
dental caries, and periodontal diseases which may cause serious gum
bleeding, especially in those with severe/moderate hemophilia, and to
avoid the need for major dental surgery. They noted they will submit
additional comments by the February 10, deadline with information and
supporting literature for why dental services are needed for bleeding
disorders beyond hemophilia. Another commenter agreed that periodic
dental care reduces the risks of dental complications requiring
haemostatic therapy (such as tooth extractions that may require
clotting factor treatment) or oral surgeries requiring clotting factor
replacement therapy. Other commenters urged that we consider finalizing
payment for hemophilia as one of the clinical scenarios for which
medically necessary dental care could be covered.
Response: In the case of dental services for individuals living
with hemophilia, we would need to identify one or more specific
clinical scenarios where there is clinical evidence that certain dental
services are so integral to the clinical success of the medical
services to manage or treat hemophilia or complications resulting from
the condition that they are inextricably linked to the other covered
service(s). We thank the commenters for their perspectives, and while
we agree that maintaining good oral health and preventing dental
problems is greatly important in the prevention of oral diseases that
can lead to serious gum bleeding, which is particularly problematic for
individuals with hemophilia, we are seeking specific evidence
supporting specific medical services for which dental services are
inextricably linked to their clinical success. We welcome additional
submissions by the February 10, deadline with information and clinical
evidence, discussed above at section II.K.1.c. of this final rule,
supporting the conclusion that certain dental services are integral and
inextricably linked to other covered services related to hemophilia and
any other bleeding disorders.
5. Request for Comment Regarding Dental Services Possibly Inextricably
Linked to Other Medicare-Covered Services
Commenters, submitters, and other interested parties have urged us
to consider the importance of access to oral health care for people
with chronic auto-immune conditions and other chronic disease
conditions, such as, but not limited to, diabetes. They have also
suggested that we consider making payment for dental services
associated with other conditions such as chronic kidney disease and end
stage renal disease, and procedures such as joint replacement, and
services such as inpatient substance use disorder treatment and long-
term use of immunosuppressants for the treatment of colitis, Crohn's,
lupus, multiple sclerosis, rheumatoid arthritis, and Sj[ouml]gren's
disease. After consideration of public comments, we are not expanding
the examples under Sec. 411.15(i)(3)(i) to include dental services
associated with additional covered medical services related to the
conditions and procedures suggested in comments. We understand and
appreciate the interest in such requests. However, the information
generally provided by commenters did not establish an inextricable link
between dental services and a covered medical service such that dental
services would not be in connection with the care, treatment, filling,
removal, or replacement of the teeth or structures supporting the
teeth. Because the Medicare statute generally prohibits payment for
dental services, payment may be made in limited situations such as when
the dental services are inextricably linked to, and substantially
related and integral to the clinical success of certain other covered
services as provided by our regulations at Sec. 411.15(i)(3), or under
the exceptions provided by section 1862(a)(12) of the Act and codified
at Sec. 411.15(i)(2). We urge interested parties to consider the
circumstances under which dental services are inextricably linked to
other covered services (not diagnoses) used to treat patients with
auto-immune conditions or other chronic conditions and support their
submissions with clinical evidence or other documentation as described
in section II.K.1.c. of this final rule. Details regarding the public
submission process are available in the CY 2023 PFS final rule (87 FR
69669 through 69670).
As summarized above in section II.K.1.c. of this final rule,
through the public submission process we finalized in the CY 2023 PFS
final rule, interested parties should submit medical evidence to
support an inextricable link between certain dental services and
covered services by providing any of the following:
(1) Relevant peer-reviewed medical literature and research/studies
regarding the medical scenarios requiring medically necessary dental
care;
(2) Evidence of clinical guidelines or generally accepted standards
of care for the suggested clinical scenario;
(3) Other ancillary services that may be integral to the covered
services; and/or
(4) Other supporting documentation to justify the inclusion of the
proposed medical clinical scenario requiring dental services.
As discussed previously in section II.K.1.c. of this final rule, in
order to consider whether certain dental services are inextricably
linked to the clinical success of other covered services, we need to
identify specific medical services for which there is medical evidence
that certain dental services are so integral to the clinical success
that they are inextricably linked to the covered service. The medical
evidence should support that in the case of surgery, the provision of
certain dental services leads to improved healing, improved quality of
surgery, and the
[[Page 79034]]
reduced likelihood of readmission and/or surgical revisions, because an
infection has interfered with the integration of the medical implant
and/or interfered with the medical implant to the skeletal structure.
Medical evidence should be clinically meaningful and demonstrate that
the dental services result in a material difference in terms of the
clinical outcomes and success of the primary medical procedure such
that the dental services are inextricably linked to, and substantially
related and integral to, the clinical success of the covered services.
Medical evidence should support that the dental services would result
in clinically significant improvements in quality and safety outcomes
(for example, fewer revisions, fewer readmissions, more rapid healing,
quicker discharge, and quicker rehabilitation for the patient), or,
medical evidence should demonstrate that the standard of care would be
to not proceed with the covered medical procedure until a dental or
oral exam is performed to address the oral complications and/or clear
the patient of an oral or dental infection.
Comment: Some commenters recited the sequelae and the oral
manifestations of diabetes mellitus. They relayed that for patients
with diabetes mellitus and periodontitis, the provision of preventive
dental care/conservative periodontal treatment leads to a statistically
and clinically significant reduction in glycated hemoglobin (HbA1c), a
key measure of metabolic control, and an established risk marker for
clinical complications of diabetes mellitus. The commenters also stated
that conservative periodontal treatment is associated with improved
health outcomes and reduced healthcare costs. They stated preventive
and restorative dental care fosters a healthy diet that is key to
diabetes treatment. They shared that they are in the process of
exploring specific diabetes-related covered services for which the
provision of inextricably linked dental care is associated with
improved outcomes and reduced cost and intend to submit their findings
by February 10, 2024, in nominations through the public process we have
established.
Response: We thank the commenters for the information they have
submitted and welcome submissions of further information through the
public process we have established. Based on the information we
received from commenters who indicated that they are still in the
process of exploring specific diabetes-related covered services for
which the provision of inextricably linked dental care associated with
improved outcomes, we are not adding an additional example in Sec.
411.15(i) related to covered medical services for diabetes at this
time. We would consider information about specific diabetes-related
covered services we receive under the public process by February 10,
2024, for CY 2025 rulemaking.
Comment: One commenter stated that our interpretation of section
1862(a)(12) of the Act is too restrictive to meaningfully expand
coverage to those with systemic autoimmune diseases. Nevertheless, they
stated that they were encouraged by our commitment to continue
exploring the inextricable link between dental and covered services
associated with immunosuppressant therapy. The commenters stated that
because dental caries and periodontal diseases are bacterial
infections, they can seed complications such as sepsis, dissecting
facial space abscesses, Ludwig's angina, and cellulitis -especially
when individuals are immunocompromised. They reported that physicians
across the medical specialties involved in treating colitis, Crohn's,
lupus, multiple sclerosis, rheumatoid arthritis, and Sj[ouml]gren's
disease have acknowledged that dental treatment to resolve dental
infections can be integral to improving outcomes among patients
requiring long-term use of immunosuppressive medications. The
commenters supported us in continuing to study the relationship between
dental care and medical services that cause immunosuppression in
patients and urge us to adopt a more expansive view of our authorities.
Other commenters wrote that while dental services are not inextricably
linked to the successful treatment of severe chronic obstructive
pulmonary disease (COPD), uncontrolled diabetes, epilepsy, Sjogren's
disease, lupus, rheumatoid arthritis, chronic kidney disease, Ludwig's
angina (and similar space infections), and/or retroperitoneal fibrosis
in every case, for many Medicare beneficiaries, oral pathologies must
be addressed when they are clinically determined to be a causal or
highly exacerbating factor in the progression and treatment of their
medical conditions.
Response: We thank the commenters for their support, perspectives,
and recommendations. We agree that additional information would be
necessary to demonstrate that dental services are inextricably linked
to covered services for autoimmune diseases and other chronic diseases
before we could add those clinical scenarios as examples in Sec.
411.15(i)(3)(i). We note that finalized policies do not prevent a MAC
from determining on a case-by-case basis that payment can be made for
certain dental services in other circumstances not specifically
addressed within Sec. 411.15(i)(3)(i), as amended by this final rule.
We will continue to engage with interested parties on ways to improve
care for Medicare beneficiaries with autoimmune diseases.
Comment: Other commenters stated that oral health services are
inextricably linked to the success of inpatient treatment for substance
use disorders. Other commenters supported the coverage of dental
services for joint replacement surgeries to lessen the infection risk.
Other commenters supported the coverage of annual dental examinations,
and treatment as clinically indicated, for individuals with chronic
kidney disease and end-stage renal disease. They stated that chronic
immunosuppression increases the risk of dental infections leading to
potentially deadly complications including bloodstream infections,
peritoneal dialysis-associated peritonitis, and the exacerbation of
chronic cardiovascular conditions. They also stated that when
established by patient-specific medical and dental parameters, dental
services can be unquestionably integral to the outcome of covered
medical procedures.
Response: We thank the commenters for the information they
submitted about joint replacement surgeries, chronic kidney disease,
end-stage renal disease, and inpatient treatment for substance use
disorders. However, commenters did not provide medical evidence to
support an inextricable link between certain dental services and
covered medical services for these conditions or medical services.
After consideration of public comments, we are not expanding the
examples under Sec. 411.15(i)(3)(i) to include dental services
associated with additional covered medical services for the conditions
and treatment suggested by commenters and would welcome submissions of
medical evidence through the public process we have established.
Comment: Another commenter requested that we consider covering
dental services when linked to significant facial trauma, for example,
from a vehicle accident, presuming Medicare coverage instead of vehicle
liability coverage.
Response: In the CY 2023 PFS final rule (87 FR 69663 through
69664), we clarified that the statute includes an exception to allow
payment to be made under Medicare Part A for inpatient hospital
services in connection with the
[[Page 79035]]
provision of dental services if the individual, because of their
underlying medical condition and clinical status or because of the
severity of the dental procedure, requires hospitalization in
connection with the provision of such services. Our regulation at Sec.
411.15(i)(2) similarly excludes payment for dental services except for
inpatient hospital services in connection with dental services when
hospitalization is required because of: (i) the individual's underlying
medical condition and clinical status; or (ii) the severity of the
dental procedure. It is possible that dental services for patients with
facial trauma could fall within this exception, depending on the
severity of the dental procedures. It is also possible that a jaw
fracture or dislocation resulting from the scenario would be within the
example in the regulation at Sec. 411.15(i)(3)(i)(C) permitting
payment under Parts A and B for certain dental services. The MAC could
make a determination that payment is permitted for certain dental
services that are inextricably linked to the clinical success of the
services to treat the facial trauma. We note that this is a clinical
scenario where there is wide variability in the nature of traumatic
facial injury, so evidence is not likely to demonstrate that dental
services are routinely inextricably linked to services to treat facial
trauma.
Comment: One commenter stated that they oppose the inclusion of
dental benefits into Medicare specifying that CMS does not possess
legislative authority for the expansion of dental applications relating
to chronic disease conditions. They believed that ``this type of
proposal is unconscionable in our current regulatory and federal
budgetary environment,'' as it would have ``significant financial costs
for the federal government and the American public'', citing the
federal budget deficit, announced on August 8, 2023, in the
Congressional Budget Office, Monthly Budget Review: July 2023.
Response: We thank the commenter for their comments. In the CY 2023
final rule (87 FR 69404, 69664) we explained that if a dental service
is performed as incident to and as an integral part of a covered
procedure or service performed by a dentist, the total service
performed by the dentist is covered, and payment can be made under
Medicare Parts A and B as appropriate. This policy is based on the idea
that some dental services that would ordinarily be excluded by statute
from payment are inextricably linked to, and substantially related and
integral to the clinical success of, certain other covered medical
services. We believe that when that is the case those dental services
are not in connection with dental services within the meaning of
section 1862(a)(12) of the Act, but are instead inextricably linked to,
and substantially related and integral to the clinical success of,
certain other covered medical services. As such, we finalized our
interpretation of the statute under section 1862(a)(12) of the Act to
permit Medicare payment under Parts A and B for dental services where
the dental service is inextricably linked to, and substantially related
and integral to the clinical success of, certain other covered medical
services and allowed payment to be made, regardless of whether the
services are furnished in an inpatient or outpatient setting. Under
these circumstances, we finalized that the exclusion under section
1862(a)(12) of the Act would not apply, because the service is not in
connection with the care, treatment, filling, removal, or replacement
of the teeth or structures supporting the teeth, but instead is
inextricably linked to, and substantially related and integral to the
clinical success of, certain other covered medical services.
6. Implementation of Payment for Dental Services Inextricably Linked to
Other Specific Covered Services
We continue to consider improvements to our payment policies for
dental services as finalized in the CY 2023 PFS final rule (87 FR 69663
through 69688). As such, we indicated that we were interested in
receiving comments from interested parties on our proposed rule on ways
to continue to implement these payment policies. Additionally, we
wanted to clarify the policies we finalized in the CY 2023 PFS final
rule. Therefore, we requested comments on several policies related to
the implementation of policies for dental services for which Medicare
payment can be made.
In the CY 2023 PFS final rule, we clarified and codified our policy
on payment for dental services and added in Sec. 411.15(i)(3)(i) of
our regulation examples of circumstances where payment can be made for
certain dental services, including a dental exam and services to
diagnose and eliminate an oral or dental infection prior to organ
transplant, cardiac valve replacement, or valvuloplasty procedures (87
FR 69664 through 69667).
We provided as examples of dental services that could be furnished
to eradicate infection services such as, but not limited to, diagnostic
services, evaluations and exams (for example, CDT codes payable with
D0120, D0140 or D0150), extractions (for example, CDT codes payable
with D7140, D7210), restorations (removal of the infection from tooth/
actual structure, such as filling procedures--for example, CDT codes
payable with D2000-2999), periodontal therapy (removal of the infection
that is surrounding the tooth, such as scaling and root planing--for
example, CDT codes payable with D4000-4999, more specifically D4341,
D4342, D4335 and D4910), or endodontic therapy (removal of infection
from the inside of the tooth and surrounding structures, such as root
canal--for example, CDT codes payable with D3000-3999). However, we
continued to believe that additional dental services, such as a dental
implant or crown, may not be considered immediately necessary to
eliminate or eradicate the infection or its source. Therefore, we
reiterated that such additional services would not be inextricably
linked to the specific covered services. As such, no Medicare payment
is made for the additional services that are not immediately necessary
to eliminate or eradicate the infection. We further clarified that we
did not propose in CY 2023, nor did we propose in CY 2024, to adjust
any payment policy for services involving the preparation for or
placement of dentures, and maintained that these services are not
payable under Medicare Parts A and B. We also reiterated our policy, as
finalized in the CY 2023 PFS final rule, that Medicare could make
payment for dental services occurring over multiple visits as
clinically appropriate. We refer readers to 87 FR 69678 for a
comprehensive discussion of this policy.
We continue to recognize that many Medicare beneficiaries have
separate or supplemental dental coverage, such as through a Medigap
plan, another private insurance plan offering commercial dental
coverage, or for those individuals dually eligible for Medicare and
Medicaid, through a state Medicaid program. As a result, we solicited
comment on the coordination of multiple dental benefits that Medicare
beneficiaries may have, whether and if so, how other plans currently
cover and pay for dental services, and what type of guidance CMS should
provide about the dental payment policies we have established and their
relationship to other separate or supplemental dental coverages.
We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: Many commenters stated CMS should issue clear guidance on
the type of dental payment policies we have established and how that
relates to any
[[Page 79036]]
supplemental dental coverage in order to ensure access to oral and
dental health care. Some commenters also noted it would be helpful to
have more information on how Medicaid, Medicare Advantage, and other
plans interact with Medicare coverage to coordinate dental services.
Response: We appreciate the commenters' thoughtful feedback and
questions regarding the operational aspects of this proposal,
specifically regarding supplemental dental coverage and coordination of
benefits, and we agree that these are necessary topics to address. We
acknowledge the need to address and clarify certain operational issues,
and we are working to address these issues and provide education and
guidance. We will continue to work with our MACs and encourage
continued feedback from interested parties to help identify concerns or
questions regarding the submission and processing of dental claims in
order to assist with the coordination of benefits amongst dentists and
issuers. We also plan to provide guidance and engage in further
rulemaking, as necessary, as operational strategies and plans are
refined and implemented. We appreciate the questions raised by
commenters and plan to take them into consideration as we continue to
advance operational issues relating to this policy, and make any
necessary changes or refinements.
Comment: Most commenters recommended that CMS develop educational
and outreach materials regarding billing and claims for any payment
policies we finalize. Additionally, some commenters stated that
dentists and transplant providers are interested in obtaining a roadmap
on matters related to submitting claims, expecting reimbursement, and
referring patients to local Medicare-participating dentists.
Response: We appreciate the questions raised by commenters and plan
to take them into consideration as we continue to refine operational
issues relating to this policy and make any necessary refinements. We
have started to create educational materials, including information
regarding enrollment, through products such as Change Request 13190,
Educational Instructions for the Implementation of the Medicare Payment
Provisions for Dental Services as Finalized in the Calendar Year (CY)
2023 Physician Fee Schedule (PFS) Final Rule, available at https://www.cms.gov/files/document/r12047bp.pdf and have provided content as
well as information regarding dental claims form (837D) via the CMS
website at https://www.cms.gov/medicare/coverage/dental. We encourage
MACs to utilize information provided in the CR to develop their own
educational and billing materials. We intend to make additional
modifications to our informational and guidance materials, including
the Medicare Claims Processing Manual, and create educational materials
to reflect refinements to payment policy for dental services, as well
as describe updates to operational and implementation aspects of this
policy. We appreciate the ongoing interest and engagement from
interested parties on all aspects of this policy.
We also solicited comment on approaches utilized by other health
plans to mitigate issues with third party payment, including when
Medicare is secondary payer and when coordinating with state Medicaid
programs. In addition, we noted there is an informal practice whereby
dental professionals may submit a dental claim to Medicare for the
purposes of producing a denial so that Medicaid or another third-party
payer can make primary payment.
Given the complexity of dental professionals submitting claims for
purposes of denial, we solicited comment on the impact of third-party
payers, including state Medicaid programs, requiring a Medicare denial
as a prerequisite for adjudication of primary payment for dental
services that are not inextricably linked to another specific covered
service. In these cases where the dental services are not inextricably
linked to another specific covered service, dental professionals must
include the appropriate HCPCS modifier on the respective dental claim
form, which serves as a certification that the professionals believe
that Medicare should not pay the claim.
We also solicited comment regarding an informal process on claims
denials for the purposes of supporting payment by other payers is
currently achieved in practice when using the dental claim form 837D.
We note that the submission of a claim without one or more of the HCPCS
modifier(s) meant to produce a denial shows belief by the enrolled
billing practitioner that Medicare, not another payer, should be the
primary payer in accordance with all applicable payment policies. As
such, submission of a claim for dental services without such a modifier
would mean that the billing practitioner believes the dental service is
inextricably linked to another Medicare-covered service, or that
payment for the service is otherwise permitted under our regulation at
Sec. 411.15(i).
We solicited comment on the practices of other payers related to
submission of claims in order to generate a denial and how these
practices impact claim submission and claim adjudication with third
party payers, including state Medicaid programs.
Additionally, we solicited comment on types of guidance, such as
best practices or criteria, that are needed for purposes of
coordinating payment for dental services under the policies specified
in the rule.
The following is a summary of the comments we received and our
responses.
Comment: Many commenters stated that CMS should provide clear
guidance for when Medicare is a primary or secondary payer.
Additionally, these commenters stated that they believe that Medicare
coverage of medically necessary dental services should be in addition
to any third-party dental plans.
Response: We appreciate the feedback from commenters as we work
towards coordinating efforts with any third-party payers, including
state Medicaid programs.
Comment: Many commenters supported CMS pursuing the adoption of the
837D dental claim form and believe implementing this form will provide
efficiency when processing dental claims. However, one commenter did
not support the idea of adopting the dental claim form because the
commenter stated they believe both the dental claim form and medical
claim form are significantly different and that the dental claim form
does not allow for modifiers, which would provide a barrier when
determining which services qualify as Medicare basic benefit. Instead,
this commenter suggested creating two new modifiers to make a
distinction for inextricable linkage, for example, one modifier that
attests to a particular dental service being inextricably linked and a
second modifier that attests to a particular dental service not
inextricably linked.
Response: We continue to work to address issues raised by
commenters, including questions related to claims processing and
efforts to accommodate the dental claim form within our claims
processing systems, effective 2024. As efforts advance to address the
implementation and functionality of claims processing systems for the
dental claim form, we intend to provide appropriate guidance and
education to interested parties. Additionally, we continue to explore
options for addressing the need to identify claims confirming
inextricable linkage between the covered medical and dental services.
These options include utilizing a HCPCS, CPT, or CDT modifier that may
[[Page 79037]]
allow dentists to attest to a particular dental service being
inextricably linked and/or a second HCPCS, CPT, CDT modifier to attest
that a particular dental service is not inextricably linked. We believe
that the possible implementation and usage of distinct modifiers or
codes for the purposes of confirming inextricable linkage will better
enable us to quantify dental services and better understand the billing
patterns of practitioners that typically furnish them. This information
is helpful to CMS for program integrity purposes and may also inform us
on whether we need to revise the policies for these services in future
rulemaking. We intend to provide additional guidance and education
around the possible usage of situationally appropriate HCPCS, CPT, and
CDT modifiers that may be utilized in order to document inextricable
linkage in claims processing. Additionally, we note that we intend to
make conforming changes to the Internet Only Manual (IOM) Publication
100-04, Medicare Claims Processing Manual, to reflect any modifications
to the guidance on the submission of claims for the purpose of denials
from CMS so third-party payers can pay as primary and intend to provide
education regarding these operational aspects of this policy.
Comment: Some commenters stated they oppose the informal practice
of dental professionals submitting a dental claim to Medicare to
produce a denial because they believe that it creates an administrative
burden for health care providers. These commenters noted it also causes
significant delays with reimbursement and can be confusing to patients
as well. A few commenters questioned the legality and validity of the
practice of submitting claims to elicit a denial. Many commenters
highlighted that the current version of the American Dental Association
dental claim form has no box for HCPCS modifiers and the commenters are
not aware of any medical carriers that currently accept the 837D dental
claim form. These commenters stated that the CMS-1500 form is typically
used when a medical denial is needed for a dental service. However, a
few commenters supported the possibility of using HCPCS modifiers on
the 837D dental claim form for the purpose of Medicare denial and
coordination benefits.
Response: We note that dentists may continue submitting claims
using the 837P and 837I claims types with existing Healthcare Common
Procedure Coding System (HCPCS) modifiers when third-party payers need
a Medicare claim denial. We continue to explore options for addressing
the need to submit a dental claim to Medicare for the purpose of
obtaining a denial so that another carrier or third-party payer may
issue primary payment via the 837D dental claims format. In addition,
we will take into consideration the potential usage of situationally
appropriate modifiers or other codes that may be utilized in making
clear that claims have been submitted expressly for the purpose of
eliciting a denial. Additionally, we note that we will make conforming
changes to the Internet Only Manual (IOM) Publication 100-04, Medicare
Claims Processing Manual, to reflect any modifications to the guidance
on the submission of claims for the purpose of denials from CMS so
third-party payers can pay as primary, including the 837D dental claim
format and provide education to the public regarding these efforts.
As described in the CY 2023 PFS final rule (87 FR 69663 through
69688), Medicare payment under Parts A and B may be made for dental
services that are inextricably linked to other covered services. We
believe the dental services and the other covered services would most
often be furnished by different professionals and that in order for the
dental services to be inextricably linked to other covered services
such that Medicare payment can be made, there must be coordination
between these professionals. This coordination should occur between the
practitioners furnishing the dental and covered services regardless of
whether both individuals are affiliated with or employed by the same
entity. This coordination can occur in various forms, such as, but not
limited to, a referral or exchange of information between the
practitioners furnishing the dental and covered services. Additionally,
any evidence of coordination between the professionals furnishing the
primary medical service and dental services should be documented. If
there is no evidence to support the exchange of information, or
integration, between the professionals furnishing the primary medical
service and the dental services, then there would not be an
inextricable link between the dental and other covered services within
the meaning of our regulation at Sec. 411.15(i)(3)(i). As such,
Medicare payment for the dental services would be excluded under
section 1862(a)(12) of the Act (though payment for the dental services
might be available through supplemental health or dental coverage).
Additionally, we sought information regarding the potential impact of
these payment policies in settings other than inpatient and outpatient
facilities, such as Federally qualified health centers (FQHCs), rural
health clinics (RHCs), etc. We understand that some Medicare
beneficiaries may access dental services in these settings and seek to
understand what, if any, impact may potentially occur within the
context of this payment policy.
As stated in the CY 2023 PFS final rule, we note that to be
eligible to bill and receive direct payment for professional services
under Medicare Part B, a dentist must be enrolled in Medicare and meet
all other requirements for billing under the PFS. Alternatively, a
dentist not enrolled in Medicare could perform services incident to the
professional services of a Medicare enrolled physician or other
practitioner. In that case, the services would need to meet the
requirements for incident to services under Sec. 410.26, including the
appropriate level of supervision, and payment would be made to the
enrolled physician or practitioner who would bill for the services (87
FR 69673). In the CY 2023 PFS final rule (87 FR 69687), we finalized
that we would continue to contractor price the dental services for
which payment is made under Sec. 411.15(i). We will maintain this
policy and continue to contractor price the dental services for which
payment is made under Sec. 411.15(i) for CY 2024. Additionally, in the
CY 2023 PFS final rule, we agreed with the suggestions made by
commenters that there may be publicly available data sources that could
aid MACs in determining these payment rates in order to account for
geographic variation. We solicited comment on what specific information
could help inform appropriate payment for these dental services (87 FR
69679).
The following is a summary of the comments we received and our
responses.
Comment: Majority of commenters supported the idea that
coordination between medical and dental professionals must be properly
documented. However, one commenter mentioned that requiring MACs to
document coordination is difficult since any coordination will vary
between different MACs. Therefore, these MACs requested that CMS to
provide guidance that ensures compliance with the coordination
requirement will be clear and simple. A few commenters requested
clarification on how practitioners should demonstrate the exchange of
information between medical and dental professionals to support
Medicare payment for dental services as inextricably linked to other
covered services and suggested the potential usage of existing CDT or
CPT
[[Page 79038]]
codes or modifiers as a mechanism to establish the inextricable link
between the dental and covered medical service.
Response: We appreciate the commenters' feedback regarding
documentation of the coordination and exchange of information between
the medical and dental professionals. In the CY 2023 PFS final rule, we
stated that we would make payment when a doctor of dental medicine or
dental surgery (referred to as a dentist) furnishes dental services
that are an integral part of the covered primary procedure or service
furnished by another physician, or nonphysician practitioner, treating
the primary medical illness. However, we explained that if there is no
exchange of information, or integration, between the medical
professional (physician or other non-physician practitioner) about the
primary medical service and the dentist regarding the dental services,
then there would not be an inextricable link between the dental and
covered medical service within the meaning of our regulation at Sec.
411.15(i)(3) (88 FR 69673). We continue to investigate operational
mechanisms to demonstrate that the exchange of information between the
Medicare enrolled medical and dental professional, such as the usage of
the CPT or CDT modifiers or codes, including the KX HCPCS modifier, the
CDT code D9311 (consultations with a medical health care professional),
CPT code for interprofessional consultation (such as CPT 99452), or
other modifiers/codes. As these operational aspects are implemented, we
intend to provide educational materials regarding documentation of the
exchange of information, or integration, between the medical
professional (physician or other non-physician practitioner) in regard
to the primary medical service and the dentist in regard to the dental
services.
Comment: One commenter opposed the requirement that only dentists
enrolled in Medicare are eligible to receive direct payment from Part B
because the commenter stated they believe this would limit Medicare
beneficiary access to medically necessary dental benefits.
Response: As explained in the CY 2023 PFS final rule, dentists not
enrolled in Medicare may provide services incident-to the professional
services of a Medicare enrolled physician or other practitioner who
would bill for the services as long as the requirements under Sec.
410.26 for incident-to services are met (87 FR 69673). Additionally,
dentists not enrolled in Medicare must coordinate payment with the
Medicare enrolled physician or other practitioner to receive payment
from Medicare.
Comment: Many commenters expressed their support for our current
policy to contractor price dental services and believe using claims
data will help inform appropriate payment for these services. However,
a few commenters were opposed to contractor pricing of dental services
and instead recommended that we should price the CDT codes in PFS RVU
files to ensure consistent payment for each code while still accounting
for geographic resource cost variations through the application of the
PFS GPCIs. Additionally, several commenters expressed concerns
regarding existing constraints on PFS funds due to the significant
amount of other physician services currently included in the PE RVU
Methodology. Therefore, these commenters noted that they believe that
any expansion of Medicare to include dental services should be paid
through a separate program independent of the physician fee schedule.
Response: We continue to believe that MACs are appropriately
situated to establish contractor prices for these services, given that
the MACs currently establish contractor pricing for the dental services
for which payment is currently made. We believe it is appropriate to
continue contractor pricing for dental services for which payment is
made in the additional clinical scenario examples we are finalizing in
this final rule, until we have additional pricing data that could
enable national pricing. We encourage MACs to continue to engage with
interested parties by providing information on how they price these
services. As such, we will continue to contractor price these services
based on the applicable payment system for services furnished. We
intend to continue engaging with interested parties regarding
establishing national payment rates for these applicable dental
services. Regarding the comment that Medicare payment for dental
services should be made through a separate program independent of the
PFS, we appreciate the commenters' feedback and note that we have
clarified our interpretation of section 1862(a)(12) of the Act, and
subsequently codified certain aspects of our current Medicare PFS
payment policies for dental services. Additionally, while we recognize
that the impact of access to these services to individual beneficiaries
may be very significant, we still do not anticipate a significant
impact in the context of overall spending and utilization under the
PFS. We intend to closely study the trends in utilization and payment
for these services and make refinements to the payment policy as needed
in future rulemaking.
Comment: Many commenters requested that we provide payment for
inextricably linked dental services in the FQHC setting. Commenters
stated that it is critical that CMS consider FQHCs' unique Medicare
payment structure and that CMS ensure that policy changes for FQHCs are
analogous to any changes made under the PFS. Commenters noted that many
FQHCs provide dental services on-site, and health center patients could
benefit from the payment policies for dental services inextricably
linked to other covered services and suggested that the FQHC billing
codes should be edited in tandem. Commenters further noted that
``physicians' services'' component of the Medicare FQHC benefit
includes services furnished by dentists. Several commenters urged that
the list of billable visit codes modified in the proposed rule be
included in the dental bundle for FQHCs or otherwise added to the list
of codes that may be billed in the FQHC setting and also requested that
any expansion in codes recognized under the PFS for dental-related
services also be applied to FQHCs.
Response: We appreciate the thoughtful feedback from commenters. We
note that we intend to continue to refine the policy's operational
aspects to ensure that the updates to this PFS payment policy are
implemented in various applicable settings, including FQHCs. We
acknowledge that the updates to the PFS payment policies for the
purposes of this policy may be appropriate in other settings that
provide PFS physician services, and we intend to make necessary
modifications to operational procedures to reflect the expansion of
this PFS payment policy, including potential updates to billable code
lists and other relevant policies in the FQHC setting. We also note
that we intend to provide additional guidance and education around the
possible usage of situationally appropriate HCPCS or other modifiers or
other CPT and/or CDT codes that may be utilized on FQHC claims in order
to document inextricable linkage in claims processing or to elicit a
denial for the purposes of payment by another payor, including
Medicaid. We continue to seek engagement with interested parties on the
appropriate application of this payment policy in other settings and
encourage the public to continue to provide additional information
regarding settings that may require special consideration in the
context of this payment policy.
[[Page 79039]]
In the CY 2023 PFS final rule (87 FR 69682), we stated that we
would update our payment files so that these dental services could be
billed appropriately under the applicable payment system for services
furnished in the inpatient or outpatient setting. We have revised the
HCPCS and PFS payment and coding files to include payment indicators
for Current Dental Terminology (CDT) codes, such as bilateralism,
multiple procedures, and other indicators that are included in the
files (posted at our website at https://www.cms.gov/medicare/medicare-fee-for-service-payment/physicianfeesched/pfs-relative-value-files) for
CDT codes. We solicited comment on whether payment indicators, as
outlined in the PFS RVU files, appropriately align with existing dental
billing and coding conventions or whether edits are necessary.
Although we proposed to continue contractor pricing services billed
using CDT codes, we solicited comment on whether the current payment
indicators included for these CDT codes follow existing dental billing
conventions, for example, for payment adjustment for multiple
procedures, and whether there is a need for additional guidance
regarding the submission of claims for services for which payment is
permitted under the regulation at Sec. 411.15(i)(3). In the CY 2023
PFS final rule (87 FR 69679), we acknowledged the need to address and
clarify certain operational issues, and we are continuing to work to
address these operational issues, including efforts to adopt the dental
claim form. These efforts include continuing to work with our MACs and
encouraging continued feedback from interested parties to help identify
concerns or questions regarding submitting and processing dental
claims.
Finally, to promote the correct coding and processing of Medicare
claims, we solicited comment on whether additional specialty codes
besides specialty codes, specialty 19 (oral surgery--dentists only) or
specialty 85 (maxillofacial surgery), should be considered for use in
Medicare.
We also solicited comment on whether these specialty codes may
impact the coordination of benefits with a third-party payer.
Finally, we acknowledged that issues could occur related to the
coordination of benefits for dual eligible beneficiaries, for example,
beneficiaries with hemophilia, and we solicited comment on how to best
coordinate a potential payment policy in this area with respect to
state Medicaid plans or private insurance.
We also solicited comment on other coordination of benefits issues,
or implementation topics that would be helpful for CMS to address in
relation to continuing to implement these PFS payment policies, and we
received public comments. The following is a summary of the comments we
received and our responses.
Comment: Many commenters stated that multiple procedure reductions
and payment indicators should be removed from the PFS payment files
because they do not align with existing dental billing and coding
conventions.
Response: We note that the multi-procedure payment reductions are a
standard payment indicator used for any service priced on the PFS
payment file. However, given feedback from interested parties, CMS has
recently removed multi-procedure payment reductions payment indicators
for dental services (described by current dental terminology(T) codes
in the July 2023 release of the PFS RVU files. Additionally, we will
continue to study and refine the payment files for dental services,
including the applicability of other payment indicators. We also intend
to identify appropriate modifications to the dental services code set
on the PFS payment files to better align with clinical practice and
implement edits in the practitioner claims processing systems to
reflect that codes for some procedures would not likely be appropriate
for usage in situations where medical services are inextricably linked
dental services, such as procedures that are solely cosmetic in nature.
We will also update appropriate Medicare payment data files to ensure
that covered dental services can be billed and paid based on the
applicable payment system for services furnished. For more information
regarding dental codes that are available for payment under Medicare,
we refer readers to the PFS RVU Files posted on our website at https://www.cms.gov/medicare/medicare-fee-for-service-payment/physicianfeesched/pfs-relative-value-files.
As we consider refinements to the payment file in the context of
how dentists furnish these services, we would be interested in
obtaining information regarding certain dental codes that would not be
covered in the context of the policies we describe. This information,
as well as additional comments or considerations, can be submitted
through the public submissions process described in section II.K.1.c.
of this rule.
Comment: A few commenters supported CMS creating new dental
specialty codes for use by dentists enrolling in the Medicare program
to promote the correct coding and processing of Medicare claims for
dental services.
Response: We appreciate the commenters' suggestion that CMS create
new dental specialty codes to advance accurate coding and claims
processing. We note that CMS issued guidance on August 31, 2023 via
Change Request 13323, New Dental Specialty Codes for Medicare,
announcing new dental specialty codes that dentists may use beginning
on January 2, 2024. These new specialty codes include: E3--Dental
Anesthesiology, E4--Dental Public Health, E5--Endodontics, E6--Oral and
Maxillofacial Pathology, E7--Oral and Maxillofacial Radiology, E9--Oral
Medicine, F1--Orofacial Pain, F2--Orthodontics and Dentofacial
Orthopedics, F3--Pediatric Dentistry, F4--Periodontics, F5--
Prosthodontics. More details regarding this change request are
available at https://www.cms.gov/files/document/r12231cp.pdf.
We thank the public for their comments regarding the implementation
considerations for these dental policies, and we will continue to work
with MACs and other interested parties to address issues raised by the
commenters. We continue to encourage feedback from interested parties
to help identify concerns or questions regarding submission and
processing of dental claims and other operational and implementation
concerns. We plan to provide guidance and engage in further rulemaking,
as necessary, as operational strategies and plans are refined and
implemented. We will also monitor service utilization to identify any
concerns about consistency of claims processing and adequacy of access
across the country. We appreciate the questions raised by commenters
and plan to take them into consideration as we continue to refine
operational issues relating to this policy and make any necessary
refinements.
In conclusion, after consideration of the public comments, clinical
practice guidelines, recommendations provided by the public, and our
analyses of the studies and research, we are finalizing additions to
our regulation at Sec. 411.15(i)(3)(i) to add dental or oral
examination performed as part of a comprehensive workup prior to, and
medically necessary diagnostic and treatment services to eliminate an
oral or dental infection prior to, or contemporaneously with
chemotherapy, chimeric antigen receptor (CAR) T-cell therapy, and the
administration of high-dose bone-modifying agents (antiresorptive
therapy) in the treatment
[[Page 79040]]
of cancer to the list of examples of services that are not subject to
the exclusion under section 1862(a)(12) of the Act and for which
payment can be made under Medicare Parts A and B. We are also
finalizing, with modifications, the addition of Sec.
411.15(i)(3)(i)(E) to add dental or oral examination performed as part
of a comprehensive workup prior to, medically necessary diagnostic and
treatment services to eliminate an oral or dental infection prior to,
or contemporaneously with, and medically necessary diagnostic and
treatment services to address dental or oral complications after,
treatment of head and neck cancer using radiation, chemotherapy,
surgery, or any combination of these, to the list of examples of
clinical scenarios that are not subject to the exclusion under section
1862(a)(12) of the Act and for which payment can be made under Medicare
Parts A and B.
Additionally, we reiterate that MACs have the flexibility to
determine on a claim-by-claim basis whether a patient's circumstances
do or do not fit within the terms of the preclusion or exception
specified in section 1862(a)(12) of the Act and Sec. 411.15(i). We
further note that the finalized policies outlined in this section of
this final rule would not prevent a MAC from making a determination
that payment can be made for dental services in other circumstances not
specifically addressed within this final rule and the finalized
amendments to Sec. 411.15(i). We remind readers once again that, to be
considered for purposes of CY 2025 PFS rulemaking, submissions through
our public process for recommendations on payment for dental services
should be received by February 10, 2024, via email at
[email protected]. Interested parties should
include the words ``dental recommendations for CY 2025 review'' in the
subject line of their email submission to facilitate processing. We
continue to stress to submitters that recommendations must include at
least one of the types of evidence listed earlier when submitting
documentation to support the inextricable link between specified dental
services and other covered services. We further note that we may also
consider recommendations that are submitted as public comments during
the comment period following the publication of the PFS proposed rule.
III. Other Provisions of the Proposed Rule
A. Drugs and Biological Products Paid Under Medicare Part B
1. Provisions From the Inflation Reduction Act Relating to Drugs and
Biologicals Payable Under Medicare Part B (Sec. Sec. 410.152, 414.902,
414.904, 489.30)
Drugs and biologicals (for the purposes of the discussion in this
section III.A., ``drugs'') payable under Medicare Part B fall into
three general categories: those furnished incident to a physician's
service (hereinafter referred to as ``incident to'') (section
1861(s)(2) of the Act), those administered via a covered item of
durable medical equipment (DME) (section 1861(n) of the Act), and
others as specified by statute (for example, certain vaccines described
in sections 1861(s)(10)(A) and (B) of the Act). Payment amounts for
most drugs separately payable under Medicare Part B are determined
using the methodology in section 1847A of the Act, and in many cases,
payment is based on the average sales price (ASP) plus a statutorily
mandated 6 percent add-on.
The Inflation Reduction Act (Pub. L. 117-169, August 16, 2022)
(hereinafter referred to as ``IRA'') contains several provisions that
affect payment limits or beneficiary out-of-pocket costs for certain
drugs payable under Part B. Among those provisions, two affect payment
limits for biosimilar biological products (hereinafter referred to as
``biosimilars''):
Section 11402 of the IRA amends the payment limit for new
biosimilars furnished on or after July 1, 2024 during the initial
period when ASP data is not available. We proposed to codify this
provision in regulation.
Section 11403 of the IRA increased the payment limit for
certain biosimilars with an ASP that is not more than the ASP of the
reference biological for a period of 5 years. We implemented section
11403 of the IRA under program instruction,126 127 as
permitted under section 1847A(c)(5)(C) of the Act. We proposed
conforming changes to regulatory text to reflect these provisions.
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\126\ https://www.cms.gov/files/document/r11496cp.pdf.
\127\ https://www.cms.gov/medicare/medicare-fee-for-service-part-b-drugs/mcrpartbdrugavgsalesprice.
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In addition, two provisions (among others in the IRA) make
statutory changes that affect beneficiary out-of-pocket costs for
certain drugs payable under Medicare Part B:
Section 11101 of the IRA requires that beneficiary
coinsurance for a Part B rebatable drug is to be based on the
inflation-adjusted payment amount if the Medicare payment amount for a
calendar quarter exceeds the inflation-adjusted payment amount,
beginning on April 1, 2023. We issued initial guidance implementing
this provision, as permitted under section 1847A(c)(5)(C) of the Act,
on February 9, 2023.\128\ We proposed conforming changes to regulatory
text.
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\128\ https://www.cms.gov/files/document/medicare-part-b-inflation-rebate-program-initial-guidance.pdf.
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Section 11407 of the IRA provides that for insulin
furnished through an item of DME on or after July 1, 2023, the
deductible is waived and coinsurance is limited to $35 for a month's
supply of insulin furnished through a covered item of DME. We have
implemented this provision under program instruction for 2023, as
permitted under section 11407(c) of the IRA.\129\ We proposed to codify
this provision in a manner that is consistent with the program
instruction for 2023.
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\129\ https://www.congress.gov/bill/117th-congress/house-bill/5376/text.
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a. Payment for Drugs Under Medicare Part B During an Initial Period
In the CY 2024 PFS proposed rule (88 FR 52385), we explained that
section 1847A of the Act provides for certain circumstances in which
the payment limit of a drug is based on its wholesale acquisition cost
(WAC). For a single source drug or biological (as defined in section
1847A(c)(6)(D) of the Act), the Medicare payment could be determined
based on WAC under the methodology specified in section 1847A(b)(4) of
the Act and described at Sec. 414.904(d)(1), which requires that
payment limits for such drugs are determined using the lesser of ASP
plus 6 percent or WAC plus 6 percent. Typically, the ASP-based payment
limit is the lesser of the two. Under section 1847A(c) of the Act,
payments for new drugs during an initial period for which ASP data is
not sufficiently available are based on WAC or the Medicare Part B drug
payment methodology in effect on November 1, 2003. Historically, WAC-
based payment under section 1847A(c)(4) of the Act was up to 106
percent of WAC, but in the CY 2019 PFS final rule (83 FR 59661 through
59666), we adopted a policy of paying up to 103 percent of WAC in this
instance. Subsequently, section 6 of the Sustaining Excellence in
Medicaid Act of 2019 (Pub. L. 116-39, enacted August 6, 2019), amended
section 1847A(c)(4) of the Act to specify, effective January 1, 2019, a
payment limit not to exceed
[[Page 79041]]
103 percent of the WAC or based on the Part B drug payment methodology
in effect on November 1, 2003 during an initial period when ASP data is
not sufficiently available. There were no regulatory changes at that
time. Therefore, we proposed to amend Sec. 414.904(e)(4) to reflect
this statutory change.
In the CY 2024 PFS proposed rule (88 FR 52385), we explained that
more recently, section 11402 of the IRA amended section 1847A(c)(4) of
the Act by adding subparagraph (B), which limits the payment amount for
biosimilars during the initial period described in section
1847A(c)(4)(A) of the Act. The provision requires that for new
biosimilars furnished on or after July 1, 2024, during the initial
period when ASP data is not sufficiently available, the payment limit
for the biosimilar is the lesser of (1) an amount not to exceed 103
percent of the WAC of the biosimilar or the Medicare Part B drug
payment methodology in effect on November 1, 2003, or (2) 106 percent
of the lesser of the WAC or ASP of the reference biological, or in the
case of a selected drug during a price applicability period, 106
percent of the maximum fair price of the reference biological.
We proposed to codify these changes to section 1847A(c)(4) of the
Act at Sec. 414.904. Specifically, we proposed to revise paragraph
(e)(4) at Sec. 414.904 by adding paragraphs (e)(4)(i)(A) and (B) to
conform the regulatory text for WAC-based payment limits before January
1, 2019 and for such payment limits on or after January 1, 2019 with
the requirements established in section 6 of the Sustaining Excellence
in Medicaid Act of 2019. We also proposed to add paragraphs (A) and (B)
to Sec. 414.904(e)(4)(ii) to codify the payment limit for new
biosimilars furnished on or after July 1, 2024 during the initial
period as required by section 1847A(c)(4)(B) of the Act.
We received public comments on these proposals. The following is a
summary of the comments we received regarding implementation of the IRA
provisions in general and our responses.
Comment: Several commenters expressed general support for proposed
regulatory changes that will reduce out-of-pocket costs for
prescription drugs.
Response: We thank the commenters for their support.
Comment: Two commenters expressed support for CMS's ongoing efforts
to implement the IRA by codifying provisions relating to Medicare Part
B payments for certain biosimilar products, and one commenter stated
that they support the proposal as a straightforward implementation of
the statute. One commenter stated that these changes will help support
the availability and use of biosimilar products and ensure that
Medicare beneficiaries benefit from the savings that were intended by
the passage of the new law.
Response: We thank these commenters for their support.
Comment: One commenter expressed concern about the financial impact
the implementation of the IRA's provisions related to the payment of
drugs will have on physician practices and requested we consider taking
steps to offset revenue losses.
Response: We appreciate the commenter's concern. In limited
circumstances, the implementation of the new lesser-than methodology
for the add-on payment for biosimilar products established under
section 11402 of the IRA may reduce provider payments, but this
reduction lasts only during the period of marketing before ASP data is
available. The temporary add-on payment for certain biosimilars with an
ASP that is not more than the ASP of the reference biological
established under section 11403 of the IRA, on the other hand,
increases payments to providers.
The following is a summary of the comments we received regarding
implementation of section 11402 of the IRA and our responses.
Comment: Regarding payment for drugs under Part B during an initial
period, one commenter stated that based on the statutory language in
section 11402 of the IRA that CMS proposes to implement, it appears
that CMS has the authority to eliminate the 3 percent add-on payment
for new drugs paid based on WAC. Therefore, the commenter urged the
Secretary to reduce the payment rate for new drugs lacking ASP data
from 103 percent to 100 percent of WAC. Because WAC is generally a
higher price than ASP and does not reflect discounts, eliminating the
WAC add-on would reduce excess payments, increase affordability for
beneficiaries and taxpayers, and improve financial incentives. The
commenter noted that in its June 2023 report to Congress,\130\ the
Medicare Payment Advisory Commission (MedPAC) recommended eliminating
add-on payments for drugs lacking ASP data that are paid based on WAC
to improve Medicare's Part B drug payment system.
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\130\ Medicare Payment Advisory Commission. 2023. Report to the
Congress: Medicare and the health care delivery system. Washington,
DC: MedPAC.
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Response: We thank commenters for these policy suggestions, and we
may consider these policies in future rulemaking. We note that under
the proposed policy, Medicare Administrative Contractors (MACs) are not
required to pay an amount equal to 103 percent of the WAC. In the
common circumstance that a WAC-based payment limit is not published on
the ASP Drug Pricing File during the initial period, MACs will be given
instruction to price drugs during the initial period in a manner
consistent with these provisions, including language stating that the
WAC-based payment limit under these policies is not to exceed 103
percent of the WAC. These instructions would not preclude MACs from
making payments that are less than 103 percent of the WAC, but rather
set a ceiling payment limit amount.
Comment: One commenter requested that we clarify whether and how
CMS determines Medicare payment and patient cost-sharing responsibility
for covered drugs assigned a temporary, unspecified billing and payment
code. The commenter suggested having temporary HCPCS codes to
facilitate drug payment during the initial period.
Response: Generally, new drugs in the initial period for which ASP
data is not sufficiently available are not included on the ASP Drug
Pricing File or the Not Otherwise Classified (NOC) Pricing File.
Policies regarding WAC-based pricing during the initial period were
finalized in the 2019 PFS final rule (83 FR 59661 through 59666) as
discussed above in this section. These policies are currently reflected
in section 20.1.3, Chapter 17 of the Medicare Claims Processing
Manual,\131\ which provides instruction for MACs to price new drugs and
biologicals that are not included on the ASP Drug Pricing File or NOC
Pricing File. The manual currently states that, for claims with dates
of service on or after January 1, 2019, the add-on percentage is up to
3 percent for WAC-based payments determined by MACs for new drugs
before an ASP-based payment limit is available. Similarly, Chapter 17
of the Medicare Claims Processing Manual will be updated following the
publication of this final rule to reflect policies finalized in this
final rule regarding payment in the initial period for new drugs. In
these circumstances, when the drug is billed using a NOC code, the MAC
will instruct the provider on how to submit a claim using a NOC code
and will determine the payment amount consistent with CMS policies.
Therefore, we disagree that a temporary
[[Page 79042]]
billing and payment code is necessary to facilitate these payments.
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\131\ https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c17.pdf, accessed September 20, 2023.
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Comment: One commenter encouraged CMS to conduct additional
outreach to providers so that they can better understand the
reimbursement policy for biosimilars.
Response: The Medicare Claims Processing Manual is typically
updated with finalized policies following the publication of a final
rule. Near the time this CY 2024 PFS final rule is issued, these
updates will be accompanied by other CMS communications, such as an MLN
Matters[supreg] article, to the provider community.
Comment: One commenter requested CMS clarify how the payment limits
for new biosimilars as amended by section 11402 of the IRA will be
implemented should legal challenges prevent or delay implementation of
the drug price negotiation program, specifically regarding the maximum
fair price (MFP) and encouraged CMS to provide education to providers
regarding the potential impacts of this policy for reimbursement
purposes, given changes related to the MFP.
Response: This comment is outside of the scope of the proposals for
payment of drugs and biologicals during the initial period. While we
appreciate the commenter's request, we cannot speak to future legal
matters, nor can we give future policy guidance with respect to these
matters.
After consideration of public comments, we are finalizing as
proposed that we will codify requirements established in section 6 of
the Sustaining Excellence in Medicaid Act of 2019 and section 11402 of
the IRA. Specifically, we are revising paragraph (e)(4) at Sec.
414.904 by adding paragraphs (e)(4)(i)(A) and (B) to conform the
regulatory text for WAC-based payment limits before January 1, 2019 and
for such payment limits on or after January 1, 2019 to the requirement
that the payment amount for a drug (except as provided in paragraph
(e)(4)(ii)) is an amount not to exceed 103 percent of the wholesale
acquisition cost or based on the Medicare Part B drug payment
methodologies in effect on November 1, 2003. We are also finalizing as
proposed the addition of paragraphs (A) and (B) to Sec.
414.904(e)(4)(ii) to codify the payment limit for new biosimilars
furnished on or after July 1, 2024, during the initial period as
required by section 1847A(c)(4)(B) of the Act.
b. Temporary Increase in Medicare Part B Payment for Certain Biosimilar
Biological Products
In the CY 2024 PFS proposed rule (88 FR 52385 through 52386), we
stated that, consistent with section 1847A(b)(8) of the Act, the
Medicare Part B payment limit for a biosimilar is its ASP plus 6
percent of the reference biological product's ASP. We noted that in the
CY 2016 PFS final rule (80 FR 71096 through 71101), we clarified that
the payment limit for a biosimilar biological product is based on the
ASP of all National Drug Codes (NDCs) assigned to the biosimilar
biological products included within the same billing and payment code
and amended Sec. [thinsp]414.904(j) to reflect this policy. We also
noted that in the CY 2018 PFS final rule (82 FR 53182 through 53186),
we finalized a policy to separately assign individual biosimilar
biological products to separate billing and payment codes and pay for
biosimilar biological products accordingly. However, we did not change
the regulation text at Sec. 414.904(j) at that time.
In the CY 2024 PFS proposed rule, we explained that section 11403
of the IRA amended section 1847A(b)(8) of the Act by establishing a
temporary payment limit increase for qualifying biosimilar biological
products furnished during the applicable 5-year period. Section
1847A(b)(8)(B)(iii) of the Act defines a ``qualifying biosimilar
biological product'' (hereinafter referred to as a ``qualifying
biosimilar'') as a biosimilar biological product (as described in
section 1847A(b)(1)(C) of the Act) with an ASP (as described in section
1847A(b)(8)(A)(i) of the Act) less than the ASP of the reference
biological for a calendar quarter during the applicable 5-year period.
Section 11403 of the IRA requires that a qualifying biosimilar be paid
at ASP plus 8 percent of the reference biological's ASP rather than 6
percent during the applicable 5-year period. Section
1847A(b)(8)(B)(ii)(I) of the Act defines the applicable 5-year period
for a qualifying biosimilar for which payment has been made under
section 1847A(b)(8) of the Act (that is, payment of ASP plus 6 percent
of the reference product's ASP) as of September 30, 2022, as the 5-year
period beginning on October 1, 2022. For a qualifying biosimilar for
which payment is first made under section 1847A(b)(8) of the Act during
the period beginning October 1, 2022, and ending December 31, 2027, the
statute defines the applicable 5-year period as the 5-year period
beginning on the first day of such calendar quarter of such
payment.\132\
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\132\ In accordance with these provisions, the ASP Drug Pricing
File reflects the temporary increased payment limit for qualifying
biosimilars beginning with the October 2022 file available at
https://www.cms.gov/medicare/medicare-fee-for-service-part-b-drugs/mcrpartbdrugavgsalesprice.
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In the CY 2024 PFS proposed rule, we proposed to add definitions of
``applicable 5-year period'' and ``qualifying biosimilar biological
product'' at Sec. 414.902 to reflect the definitions in statute. In
addition, we proposed to make conforming changes to regulatory text to
reflect the requirements mandated under section 1847A(b)(8)(B) of the
Act for the temporary payment limit increase for qualifying biosimilar
biological products at Sec. 414.904 (j) by adding paragraphs (j)(1)
and (2).
We received public comments on our proposals related to the
temporary increase in Medicare Part B payment for certain biosimilar
biological products. The following is a summary of the comments we
received and our responses.
Comment: Two commenters supported CMS's ongoing efforts to
implement the IRA by codifying provisions relating to Medicare Part B
payments for certain biosimilar drugs. One commenter stated that these
changes will help support the availability and use of biosimilar
products and ensure that Medicare beneficiaries benefit from the
savings that were intended by the passage of the new law.
Response: We thank these commenters for their support.
Comment: One commenter encouraged CMS to conduct additional
outreach to providers so that they can better understand the
reimbursement policy for biosimilars.
Response: We appreciate the commenter's recommendations related to
outreach and education. CMS has included information on our website
related to section 11403 \133\ and following the publication of this
final rule, the Medicare Claims Processing Manual will be updated with
the finalized policies regarding payment of biosimilars. These updates
will be accompanied by other CMS communications, such as an MLN
Matters[supreg] article, to the provider community. Overall, CMS shares
the commenter's interest in ensuring providers have the educational
[[Page 79043]]
resources needed to understand payment policies.
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\133\ https://www.cms.gov/medicare/payment/fee-for-service-providers/part-b-drugs/average-drug-sales-price/asp-reporting#WhatstheTemporaryIncreaseinPaymentforBiosimilarBiologicals.
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After consideration of public comments, we are finalizing as
proposed the definitions of ``applicable 5-year period'' and
``qualifying biosimilar biological product'' at Sec. 414.902 to
reflect the definitions in statute. In addition, we are finalizing as
proposed making conforming changes to regulatory text to reflect the
requirements mandated under section 1847A(b)(8)(B) of the Act for the
temporary payment limit increase for qualifying biosimilar biological
products at Sec. 414.904(j) by adding paragraphs (j)(1) and (2).
c. Inflation-Adjusted Beneficiary Coinsurance and Medicare Payment for
Medicare Part B Rebatable Drugs
As discussed in the CY 2024 PFS proposed rule (88 FR 52386),
section 11101(a) of the IRA amended section 1847A of the Act by adding
a new subsection (i), which requires the payment of rebates into the
Supplementary Medical Insurance Trust Fund for Part B rebatable drugs
if the payment limit amount exceeds the inflation-adjusted payment
amount, which is calculated as set forth in section 1847A(i)(3)(C) of
the Act. The provisions of section 11101 of the IRA are currently being
implemented through program instruction, as directed under section
1847A(c)(5)(C) of the Act. As such, we issued guidance for the
computation of inflation-adjusted beneficiary coinsurance under section
1874A(i)(5) of the Act and amounts paid under section 1833(a)(1)(EE) of
the Act on February 9, 2023.134 135 For additional
information regarding implementation of section 11101 of the IRA,
please see the inflation rebates resources page at https://www.cms.gov/inflation-reduction-act-and-medicare/inflation-rebates-medicare.
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\134\ https://www.cms.gov/files/document/medicare-part-b-inflation-rebate-program-initial-guidance.pdf.
\135\ In addition, beginning with the April 2023 ASP Drug
Pricing file, the file includes the coinsurance percentage for each
drug and specifies ``inflation-adjusted coinsurance'' in the
``Notes'' column if the coinsurance for a drug is less than 20
percent of the Medicare Part B payment amount. Drug pricing files
are available at https://www.cms.gov/medicare/medicare-fee-for-service-part-b-drugs/mcrpartbdrugavgsalesprice.
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Section 1847A(i)(5) of the Act requires that for Part B rebatable
drugs, as defined in section 1847A(i)(2)(A) of the Act, furnished on or
after April 1, 2023, in quarters in which the amount specified in
section 1847A(i)(3)(A)(ii)(I) of the Act (or, in the case of selected
drugs described under section 1192(c) of the Act, the amount specified
in section 1847A(b)(1)(B) of the Act), exceeds the inflation-adjusted
payment amount determined in accordance with section 1847A(i)(3)(C) of
the Act, the coinsurance will be 20 percent of the inflation-adjusted
payment amount for such quarter (hereafter, the inflation-adjusted
coinsurance amount). This inflation-adjusted coinsurance amount is
applied as a percent, as determined by the Secretary, to the payment
amount that would otherwise apply for such calendar quarter in
accordance with section 1847A(b)(1)(B) or (C) of the Act, as
applicable, including in the case of a selected drug. We proposed to
codify the coinsurance amount for Part B rebatable drugs as required by
section 1847A(i)(5) of the Act in Sec. 489.30, specifically by adding
a new paragraph (b)(6).
Section 11101(b) of the IRA amended section 1833(a)(1) of the Act
by adding a new subparagraph (EE), which requires that if the payment
amount described in section 1847A(i)(3)(A)(ii)(I) of the Act (or, in
the case of a selected drug, the payment amount described in section
1847A(b)(1)(B) of the Act) exceeds the inflation-adjusted payment
amount of a Part B rebatable drug, the Part B payment will, subject to
the deductible and sequestration, equal the difference between such
payment amount and the inflation-adjusted coinsurance amount. In the
proposed rule, we proposed to codify the Medicare payment for Part B
rebatable drugs in Sec. 410.152, specifically by adding new paragraph
(m).
We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: Several commenters expressed support for our proposed
codification of section 11101 of the IRA, including one that cited that
it would reduce Medicare beneficiaries' out-of-pocket costs.
Response: We thank the commenters for their support.
Comment: One commenter pointed out that we inverted text in the
preamble of the proposed rule at 88 FR 52386 describing the amendment
section 11101(b) of the IRA made to section 1833(a)(1) of the Act and
identified a typographical error in the text of proposed new paragraph
(b)(6) at 42 CFR 489.30.
Response: We thank the commenter for identifying our errors in the
preamble and proposed regulatory text. We are correcting both errors in
this final rule.
Comment: One commenter requested that we clarify whether a
reduction or waiver of an inflation rebate due to shortage would affect
the reduced beneficiary coinsurance for that drug. The commenter stated
that the section relating to the reduction or waiver of the rebate for
shortages and severe supply chain disruptions, section 1847A(i)(3)(G)
of the Act, makes no cross-references to the application of the
inflation-adjusted beneficiary coinsurance, which is implemented in
section 1847A(i)(5) of the Act.
Another commenter advocated against of the inclusion of Medicare
Advantage units in the calculation of Part B drug inflation rebates.
The commenter stated the statutory definition of a Part B rebatable
drug in section 1847A(i)(2)(A) of the Act precludes counting payments
for drugs under Part C.
Response: We note that since we did not make any proposals in this
rulemaking related to the calculation of the inflation-adjusted payment
amount described in section 1847A(i)(3)(C) of the Act, the calculation
of the rebate amount in section 1847(i)(3)(A) of the Act, or the
reduction or waiver for shortages and severe supply chain disruptions
described in section 1847A(i)(3)(G) of the Act, these comments are out
of scope. We note that these issues were addressed in the Medicare Part
B Drug Inflation Rebates Paid by Manufacturers: Initial Memorandum,
Implementation of Section 1847A(i) of the Social Security Act, and
Solicitation of Comments dated February 9, 2023 (the ``initial Part B
inflation rebate guidance''), and we gave interested parties the
opportunity to comment on the initial Part B inflation rebate guidance.
We will consider the comments we received in response to the initial
Part B inflation rebate guidance when developing future guidance on the
Medicare Prescription Drug Inflation Rebate Program.
After consideration of public comments, we are finalizing the
codification of the coinsurance amount and the Medicare payment for
Part B rebatable drugs at Sec. 489.30 and Sec. 410.152, respectively,
as proposed, except insofar as correcting the typographical error in
new paragraph (b)(6) at Sec. 489.30.
d. Limitations on Monthly Coinsurance and Adjustments to Supplier
Payment Under Medicare Part B for Insulin Furnished Through Durable
Medical Equipment
In the CY 2024 PFS proposed rule (88 FR 52386), we stated that
drugs furnished through a covered item of DME are covered under
Medicare Part B as provided in sections 1861(n) and (s)(6) of the Act.
Insulin administered through covered DME, such as a durable
[[Page 79044]]
insulin pump, is covered under this benefit. As required by section
1842(o)(1)(C) and (D) of the Act, effective January 1, 2017, infusion
drugs furnished through DME, including insulin, are paid under section
1847A of the Act (see 82 FR 53180 through 53181), which is typically
ASP plus 6 percent. Prior to July 1, 2023, beneficiaries are
responsible for coinsurance of 20 percent of the payment amount of such
insulin, subject to the Part B deductible.
In the CY 2024 PFS proposed rule we explained that section 11407 of
the IRA made three changes to the way beneficiaries pay for insulin
furnished through covered DME. First, section 11407(a) of the IRA
amended section 1833(b) of the Act to waive the Part B deductible for
insulin furnished through covered DME on or after July 1, 2023. Second,
section 11407(b)(2) of the IRA amended section 1833(a) of the Act to
establish a limit of $35 on the beneficiary coinsurance amount for a
month's supply of such insulin furnished on or after July 1, 2023. This
statutory change means that the beneficiary coinsurance responsibility,
which is limited to $35 for a month's supply of insulin, could equal
less than 20 percent if the Part B payment amount of a month's supply
of insulin is greater than $175. Third, section 11407(b)(2) of the IRA
also added a new sentence to section 1833(a) of the Act to require the
Secretary to increase to the Medicare Part B payment to above 80
percent in the case the coinsurance amount for insulin furnished
through covered DME equals less than 20 percent of the payment amount
to pay for the full difference between the payment amount and
coinsurance. The adjustment specified in paragraph (b)(2) ensures the
supplier is not responsible for the reduction in the beneficiary
coinsurance amount.
The above provisions were implemented through program
instruction,\136\ as required by section 11407(c) of the IRA, for CY
2023. Section 80 in Chapter 17 \137\ and section 140 in Chapter 20
\138\ of the Medicare Claims Processing Manual will be updated to
reflect these changes, effective July 1, 2023. To operationalize this
provision, we stated that the $35 coinsurance limit applies to the
duration of the calendar month in which the date of service occurs. As
stated in the section 110.5, Chapter 15 of the Medicare Benefit Policy
Manual,\139\ the date of service on the claim must be the date that the
beneficiary or authorized representative receives the insulin or, for
mail order, the date the insulin is shipped. A new $35 coinsurance
limit for a month's supply applies to each calendar month. It follows
that, as stated in the program instruction, when a 3-month supply (that
is, the amount of such insulin that is required for treatment for up to
3 calendar months) is billed for insulin furnished through covered DME,
a coinsurance limit of $105 would apply for that 3-calendar month
period ($35 coinsurance limit for each month's supply of insulin). The
program instruction also states that the MACs will ensure that
coinsurance does not exceed $35 for a 1-month supply or $105 for a 3-
month supply for claims billing insulin administered through covered
DME.
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\136\ https://www.cms.gov/files/document/r11917cp.pdf.
\137\ https://www.cms.gov/regulations-and-guidance/guidance/
manuals/downloads/clm104c17.pdf.
\138\ https://www.cms.gov/regulations-and-guidance/guidance/manuals/downloads/clm104c20_dmemay23_r2.pdf.
\139\ https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/bp102c15.pdf.
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In the CY 2024 PFS proposed rule, we proposed to codify these
elements (that are currently in program instruction) for CY 2024 and
future years in regulation text, because section 11407(c) of the IRA
states that only implementation for CY 2023 may be through program
instruction or other forms of guidance. Specifically, we proposed to
codify the new statutory monthly coinsurance limits of $35 for a 1-
month supply and $105 for a 3-month supply at Sec. [thinsp]489.30 by
adding paragraph (b)(7) and the adjustment to the supplier payment at
Sec. 410.152 by adding paragraph (n). In addition, we proposed to
codify at Sec. [thinsp]489.30 that the $35 coinsurance limit for a
month's supply of insulin furnished through covered DME will apply to
the duration of the calendar month in which the date of service (or
services) occurs. In other words, the $35 coinsurance limit will apply
for a month's supply of insulin each calendar month. Similarly, we
proposed to codify that the $105 coinsurance limit for 3 months' supply
of insulin furnished through covered DME will apply to the duration of
the calendar month in which the date of service (or services) occurs
and the 2 following calendar months.
We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: One commenter expressed support for our proposed
regulatory codification of section 11407 of the IRA.
Response: We thank the commenter for their support.
Comment: One commenter requested clarification that compounded
insulin is exempt from the Part B insulin coinsurance limitation
consistent with how compounded insulin is treated for purposes of the
Medicare Part D Coverage Gap Discount Program (CGDC) and the
Manufacturer Discount Program. The commenter requested that we clarify
that several forms of compounded insulin are exempt from the
coinsurance limitation, including insulin transferred from vials to a
cartridge for insertion into a pump, pre-drawn syringes for patients
who cannot prepare their own medication, insulin drips, and insulin
added to total parenteral nutrition (TPN) or intradialytic parenteral
nutrition (IDPN).
Response: We thank the commenter for their question. Products that
the commenter refers to as ``compounded insulin'' that are furnished
through a covered item of DME are subject to the monthly coinsurance
limitation. The coinsurance limitation of $35 for a month's supply
would apply to insulin that is transferred from vials into a cartridge
for insertion into an insulin pump given that the pump is a covered
item of DME. However, insulin that is not administered through a
covered item of DME and is instead administered through, for example,
pre-drawn syringes, would not be subject to the monthly coinsurance
limitation. For information on the applicability of the coinsurance
limitation to insulin administered through syringes, see the Part D
Inflation Reduction Act (IRA) Cost Sharing Maximum Reports for Part D
Sponsors memorandum \140\ and Frequently Asked Questions about Medicare
Insulin Cost-Sharing Changes in the Prescription Drug Law.\141\
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\140\ https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/IRA_Cost_Sharing_Maximum_Reports_508_G.pdf.
\141\ https://www.cms.gov/files/document/frequently-asked-questions-medicare-part-d-insulin-benefit.pdf.
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We note that intravenous (IV) insulin drips are not commonly
administered in physician offices and coverage for outpatient IV
insulin therapy (OIVIT) was rescinded in 2010 for claims with dates of
service on and after December 23, 2009, pursuant to Change Request
6775,\142\ after CMS determined from a review of evidence that OIVIT
does not improve health outcomes in Medicare beneficiaries. Typically,
IV insulin drips would not occur in a patient's home because of the
inability for a patient or
[[Page 79045]]
a patient's caregiver to safely supervise the administration.
Therefore, we do not anticipate administration of IV insulin drips
outside of a hospital setting under close monitoring, not covered under
DME. Regarding parenteral nutrition, we note that parenteral nutrition
is covered under the Medicare Part B benefit for prosthetic devices.
Insulin that is not administered through a covered item of DME and is
instead administered through, for example, a prosthetic device, would
not be subject to the monthly coinsurance limitation.
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\142\ https://www.cms.gov/regulations-and-guidance/guidance/transmittals/downloads/r1930cp.pdf.
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After consideration of public comments, we are finalizing as
proposed the new paragraph (b)(7) at Sec. [thinsp]489.30 for the
limitations on monthly coinsurance for insulin furnished through a
covered item of DME. We are also finalizing as proposed the new
paragraph (n) at Sec. 410.152 for the adjustment to the supplier
payment under Medicare Part B.
e. Indexing the Part B Deductible to Inflation
Prior to the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA) (Pub. L. 108-173), the Part B
deductible was set in statute. After setting the 2005 deductible amount
at $110.00, section 629 of the MMA (amending section 1833(b) of the
Act) required that the Part B deductible be indexed beginning in 2006.
The inflation factor to be used each year is the annual percentage
increase in the Part B actuarial rate for enrollees aged 65 and over.
Specifically, the 2024 Part B deductible is calculated by multiplying
the 2023 deductible by the ratio of the 2024 aged actuarial rate to the
2023 aged actuarial rate. The amount determined under this formula is
then rounded to the nearest $1.00. Although Sec. 410.160 was amended
to reflect the statutory change, we did not make the corresponding
revision in Sec. 489.30. Earlier in this section, we finalized
additional changes to the regulatory text for allowable charges under
Part B for rebatable drugs and insulin furnished on or after July 1,
2023, through an item of durable medical equipment covered under
section 1861(n) of the Act in Sec. 489.30(b)(6) and (7), respectively.
Therefore, we are finalizing the revision to Sec. 489.30(b)(1) to
conform the regulatory text for the Part B deductible with the
statutory change made by section 629 of the MMA and the IRA provisions
that make statutory changes that affect beneficiary out-of-pocket costs
for certain drugs payable under Medicare Part B.
2. Request for Information (RFI): Drugs and Biologicals Which Are Not
Usually Self-Administered by the Patient, and Complex Drug
Administration Coding
Section 1861(s)(2)(A) of the Act allows Medicare to pay for
services and supplies, including drugs and biologicals (hereafter,
drugs) that are not usually self-administered by the patient, which are
furnished as ``incident to'' a physician's professional service.
Section 112 of the Benefits, Improvements & Protection Act of 2000
(BIPA) (Pub. L. 106-554, December 21, 2000) amended the above-
referenced sections 1861(s)(2)(A) and 1861(s)(2)(B) of the Act, which
formerly referred to drugs ``which cannot be self-administered,'' to
read, ``which are not usually self-administered.'' Drugs that are
``usually self-administered'' are thus statutorily excluded from
coverage and payment under Part B under the ``incident to'' benefit.
We have provided definitions and other guidance for MACs regarding
determinations on drugs that are ``not usually self-administered by the
patient'' in Chapter 15, Section 50.2 of the Medicare Benefit Policy
Manual.\143\ Chapter 15 also describes the evidentiary criteria that
MACs should use in determining whether a drug is usually self-
administered. The guidance directs MACs to publish a description of the
process they use to make that determination, and to publish a list of
the drugs that are subject to the self-administered exclusion on their
website.\144\ The guidance also requires that this list include the
data and rationale that led to the determinations. This list is
referred to as the ``self-administered drug (SAD) list,'' and each MAC
maintains their own version of the list, which is applicable to that
MAC's area of jurisdiction. While the lists are often similar between
MACs, they are not identical. Drugs that are put on a SAD list are
excluded from Part B coverage, but in those situations, they are almost
always covered by Medicare Part D prescription drug coverage. For
several years, interested parties have requested that we update and
clarify this SAD list guidance. These parties believe that the current
guidance may not adequately address circumstances posed by newly
approved drugs.
---------------------------------------------------------------------------
\143\ Ibid.
\144\ https://www.cms.gov/regulations-and-guidance/guidance/manuals/downloads/bp102c15.pdf.
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In a similar vein, we have received concerns from interested
parties that non-chemotherapeutic complex drug administration payment
has become increasingly inadequate due to existing coding and Medicare
billing guidelines that do not accurately reflect the resources used to
furnish these infusion services. Interested parties have asserted that
these infusion services are similar to complex and clinically intensive
Chemotherapy and Other Highly Complex Biological Agent Administration
(``Chemotherapy Administration'') services that are billed using CPT
code series 96401-96549, as opposed to Therapeutic, Prophylactic, and
Diagnostic Injections and Infusion services billed using CPT code
series 96360-96379. We note that we discuss our policies for these
services in Pub. 100-04 Medicare Claims Processing Manual, Chapter 12,
Section 30.5D.\145\
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\145\ https://www.cms.gov/regulations-and-guidance/guidance/manuals/downloads/clm104c12.pdf.
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In the CY 2024 PFS proposed rule (88 FR 52387), we solicited
comments on the above two policy areas, since they both involve Part B
drug payment policies that have been impacted by new developments in
the field. In an effort to promote coding and payment consistency and
patient access to infusion services, we solicited comments and
information from interested parties regarding the relevant resources
involved, as well as inputs and payment guidelines and/or
considerations, that could be used in determining appropriate coding
and payment for complex non-chemotherapeutic drug administration. We
solicited comments on whether or not we should revise our policy
guidelines as discussed to better reflect how these specific infusion
services are furnished and should be billed.
We also solicited comments regarding our policies on the exclusion
of coverage for certain drugs under Part B which are usually self-
administered by the patient. Specifically, we solicited comments
regarding our policies for the following items:
Definitions of the following terms, as referenced in this
section:
++ ``Administered.''
++ ``Self-Administered.''
++ ``Usually.''
++ ``By the patient.''
The process for determining which drugs are classified as
those ``not usually self-administered by the patient.''
The process for issuing decisions on which drugs are
classified as those ``not usually self-administered by the patient,''
and the process for issuing any changes to those classifications.
The relevant resources involved, as well as inputs and
payment guidelines and/or considerations, that could be
[[Page 79046]]
used in determining appropriate coding and payment for complex non-
chemotherapeutic drug administration.
Whether or not CMS should revise policy guidelines to
better reflect how complex non-chemotherapeutic drug administration
infusion services are furnished and billed.
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 regarding our policies on self-
administered drugs. The comments addressed several critical issues in
this space, including appeals, FDA labeling, and accommodating patients
who are under caregivers' care and/or patients who do not have the
ability self-administer drugs. Commenters provided robust feedback on
the self-administered drug issues listed above, and on related issues
as well.
Response: We thank commenters for their attention to these policies
and for sharing our desire to improve health equity and healthcare
access for Medicare enrollees. We plan to consider all comments, and we
look forward to continued discussions with interested parties as we
work towards potentially developing changes to these policies in future
rulemaking.
Comment: We received a number of comments in response to our
Request for Information (RFI) regarding appropriate reimbursement for
non-chemotherapeutic complex drug administration coding. Commenters
urged CMS to provide additional guidance clarifying the conditions
under which infusion drugs can be considered complex and may be
appropriately reported using the chemotherapy administration CPT codes
96401-96549. Commenters expressed concern with the MAC guidance
currently in effect for complex drug administration services.
Commenters asserted that the current reimbursement rates and billing
considerations for non-chemotherapeutic complex infusion services
provided by the MACs are inconsistent, inadequate, and in conflict with
CMS billing policies.
Response: We appreciate commenters' concerns regarding the complex
drug administration payment policy. Our current guidance regarding
coding rules for chemotherapy administration and nonchemotherapy
injections and infusion services, as documented in 100-4 Chapter 12,
section 30.5 of our internet Only Manual (IOM), outlines the categories
under which payment is made for both types of injections and infusions
and the considerations for determining what drugs may be considered
chemotherapy under Medicare.\146\ There, we state that ``Chemotherapy
administration codes (CPT codes 96401-96549) apply to parenteral
administration of non-radionuclide anti-neoplastic drugs; and also, to
anti-neoplastic agents provided for treatment of noncancer diagnoses
(for example, cyclophosphamide for auto-immune conditions) or to
substances such as monoclonal antibody agents, and other biologic
response modifiers.'' We also provide examples of specific drugs,
including monoclonal antibody drugs, but we also clarify that the
examples discussed do not represent an exhaustive list of drugs that
may be administered using complex administration services. We further
state that ``A/B MACs (B) may provide additional guidance as to which
drugs may be considered to be chemotherapy drugs under Medicare.''
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\146\ https://www.cms.gov/regulations-and-guidance/guidance/manuals/downloads/clm104c12.pdf.
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We acknowledge the commenters' position that the clinical work and
expense for some complex drug infusion services are not adequately
accounted for as currently reimbursed by Medicare. However, we note
that Medicare payment for the chemotherapy administration CPT code
series (96401-96549) accounts for clinical staff and supply costs as
part of physician practice expenses for the administration service. The
practice expense costs include preservice preparation activities,
intra-service constant monitoring, and post-service period activities
performed by registered nurses or oncology-certified nurses. The supply
items also include equipment such as a biohazard hood. Medicare payment
for the therapeutic, prophylactic, and diagnostic injections and
infusion CPT code series (96360-96379) also accounts for clinical staff
activities and supply equipment as part of the practice expense for the
administration service with less clinical staff service time and fewer
equipment items. However, we understand and acknowledge the constantly
evolving practice of medicine and advancements in complex drug
administration that may need to be considered relative to our existing
payment policies. We are interested in future discussions with
interested parties to work towards developing policies that accurately
account for the costs involved in complex drug administration services.
3. Requiring Manufacturers of Certain Single-Dose Container or Single-
Use Package Drugs To Provide Refunds With Respect To Discarded Amounts
(Sec. Sec. [thinsp]414.902 and 414.940)
a. Background
Section 90004 of the Infrastructure Investment and Jobs Act (Pub.
L. 117-58, November 15, 2021) (hereinafter is referred to as ``the
Infrastructure Act'') amended section 1847A of the Act to redesignate
subsection (h) as subsection (i) and insert a new subsection (h), which
requires manufacturers to provide a refund to CMS for certain discarded
amounts from a refundable single-dose container or single-use package
drug (hereafter referred to as ``refundable drug''). The refund amount
is the amount of discarded drug that exceeds an applicable percentage,
which is required to be at least 10 percent, of total charges for the
drug in a given calendar quarter.
In the CY 2023 PFS final rule (87 FR 69710 through 69734), we
adopted many policies to implement section 90004 of the Infrastructure
Act. We finalized the requirement that billing providers and suppliers
report the JW modifier for all separately payable drugs with discarded
drug amounts from single use vials or single use packages payable under
Part B, beginning January 1, 2023. We also finalized the requirement
that billing providers and suppliers report the JZ modifier for all
such drugs with no discarded amounts beginning no later than July 1,
2023, and we stated that we would begin claims edits for both the JW
and JZ modifiers beginning October 1, 2023 (87 FR 69718 through 69719).
Subsequent to the issuance of the CY 2023 PFS final rule, CMS published
the JW Modifier and JZ Modifier Policy Frequently Asked Questions (FAQ)
document \147\ addressing the correct use of these modifiers. We
adopted a definition of ``refundable single-dose container or single-
use package drug'' at Sec. 414.902, which also specifies exclusions
from this definition (87 FR 69724). These three exclusions are:
radiopharmaceutical or imaging agents, certain drugs requiring
filtration, and drugs approved by FDA on or after November 15, 2021,
and for which payment has been made under Part B for fewer than 18
months. Regarding reports to manufacturers, we specified that we would
send reports (including information described in section 1847A(h)(1) of
the Act) for each
[[Page 79047]]
calendar quarter on an annual basis to all manufacturers of refundable
drugs (87 FR 69726). We finalized how the refund amount will be
calculated at Sec. [thinsp]414.940 (87 FR 69731). Regarding drugs with
unique circumstances for which we can increase the applicable
percentage otherwise applicable for determining the refund, we adopted
an increased applicable percentage of 35 percent for drugs
reconstituted with a hydrogel and with variable dosing based on
patient-specific characteristics (87 FR 69731). Lastly, we adopted a
dispute resolution process through which manufacturers can challenge
refund calculations, and we established enforcement provisions
(including manufacturer audits, provider audits, and civil money
penalties required by statute) (87 FR 69732 through 69734).
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\147\ https://www.cms.gov/medicare/medicare-fee-for-service-payment/hospitaloutpatientpps/downloads/jw-modifier-faqs.pdf.
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As noted in the CY 2023 PFS final rule (87 FR 69711), sections
11101 and 11102 of the Inflation Reduction Act (Pub. L. 117-169, August
16, 2022) (IRA) established new requirements under which manufacturers
must pay inflation rebates if they raise their prices for certain Part
B and Part D drugs faster than the rate of inflation. Drug
manufacturers are required to pay rebates to Medicare if prices for
certain Part B drugs increase faster than the rate of inflation for
quarters beginning with the first quarter of 2023; drug manufacturers
are required to pay rebates to Medicare if prices for certain Part D
drugs increase faster than the rate of inflation over 12-month periods,
starting with the 12-month period that began October 1, 2022.
We explained that we believe implementation of the Part B and Part
D inflation rebate programs established under the IRA should be
considered together with the operational implications of the discarded
drug refunds, because the refunds and rebates both require CMS to
accept from drug manufacturers payments that must be deposited into the
Federal Supplementary Medical Insurance (SMI) Trust Fund.
Therefore, to align the operation of these programs and minimize
burden, we declined to finalize some aspects of the invoicing and
collection of discarded drug refunds. Specifically, we declined to
finalize the timing of the initial reports and which quarters'
information will be included in each report. We also declined to
finalize specific dates by which manufacturer refund obligations are
due and those associated with the dispute resolution process, as those
are scheduled in tandem with the reporting dates. Lastly, we stated our
intent to address these aspects in future rulemaking.
In the CY 2024 PFS proposed rule (88 FR 52388 through 52395), we
proposed the date of the initial report to manufacturers, the date for
subsequent reports, method of calculating refunds for discarded amounts
in lagged claims data, method of calculating refunds when there are
multiple manufacturers for a refundable drug, increased applicable
percentages for certain drugs with unique circumstances, and a future
application process by which manufacturers may apply for an increased
applicable percentage for a drug, which would precede proposals to
increase applicable percentages in rulemaking. We also proposed
modification to the JW and JZ modifier policy for drugs payable under
Part B from single-dose containers that are furnished by a supplier who
is not administering the drug.
b. Provision of Information to Manufacturers
In the CY 2023 PFS final rule (87 FR 69724 through 69726), we
discussed our proposals related to meeting the requirements under
section 1847A(h)(1) of the Act related to the timing and contents of
the report to manufacturers, including what types of information to
include, which quarters' data we would include in the initial report,
the amount of lagged claims data we would include, whether to send
reports quarterly or annually, and the definition of a manufacturer.
However, we explained that due to the enactment of the IRA and our
efforts to align the operations of the refunds with the inflation
rebate programs and minimize burden, we did not finalize certain
aspects of the discarded drug refund provision. Specifically, we did
not finalize the date that we would send the first report to
manufacturers or which quarters' information would be included in each
report.
Although we did not finalize the noted aspects related to timing,
we adopted regulations at Sec. 414.940(a)(3) providing that we will
send reports to manufacturers on an annual basis and indicated in the
preamble text that reports will contain discard information (described
in section 1847A(h)(1)(A) of the Act) for each calendar quarter (87 FR
69724 through 69726). We also finalized that we would send reports to
all manufacturers of refundable drugs. In addition, in response to
commenters suggesting that we provide manufacturers an opportunity to
engage with us on discard amount data in the first year of this
provision's implementation, we stated that we would issue, no later
than December 31, 2023, a preliminary report on estimated discarded
amounts based on available claims data from the first two quarters of
CY 2023.
In the CY 2024 PFS proposed rule (88 FR 52388 through 52389), we
discussed implementing the discarded drug refund in a timely manner. We
proposed to issue the initial refund report to manufacturers, to
include all calendar quarters for 2023, no later than December 31,
2024. (Note that this report, which we refer to as the ``initial refund
report'' in this final rule, will be separate and distinct from the
preliminary report that we will issue by December 31, 2023, which will
include estimated discarded amounts based on available claims data for
the first 2 quarters of CY 2023.)
With respect to subsequent annual reports, that is, reports for
quarters in CY 2024 and thereafter, we stated our intent to align
delivery of the refund reports with the delivery of Part B and Part D
inflation rebate reports to the extent practicable. We noted that in
the initial guidance for Part B inflation rebates,\148\ it states that
inflation rebate reports will be sent on a quarterly basis, each no
later than 6 months after the end of the calendar quarter as required
in section 1847A(i)(1)(A) of the Act. We also noted that the guidance
states, consistent with section 1847A(i)(1)(C) of the Act, that we may
delay reporting Part B inflation rebate information for calendar
quarters in CY 2023 and CY 2024 until not later than September 30,
2025.\149\
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\148\ https://www.cms.gov/files/document/medicare-part-b-inflation-rebate-program-initial-guidance.pdf.
\149\ https://www.cms.gov/files/document/medicare-part-b-inflation-rebate-program-initial-guidance.pdf.
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To align these reports, we proposed that, other than for the
initial refund report, (which we are finalizing that we will issue no
later than December 31, 2024, as described in section III.A.3.b of this
final rule), we would send annual refund reports for discarded drug
refunds for the 4 quarters of a calendar year at or around the time we
plan to send Part B inflation rebate reports for the first quarter of
the following year. Thus, for example, we would send the second refund
report for the calendar quarters in 2024 when we plan to send the
inflation rebate report for Q1 2025, which is required to be sent no
later than September 30, 2025, as required in section 1847A(i)(1)(C) of
the Act. We note that the timeframe for Part B inflation rebate reports
has not yet been finalized; the final timing will be addressed in the
revised Part B inflation rebate guidance.
[[Page 79048]]
We noted in the CY 2023 PFS final rule (87 FR 69725), because
providers and suppliers have a 12-month period to submit Medicare Part
B claims, including claims for drugs payable under Part B, there can be
a lag between the date of service when a drug is administered and when
the claim is submitted and adjudicated. Therefore, there is a lag in
available JW modifier data for any given date of service quarter. We
provided our evaluation of July 2010 Medicare Part B claims in the
Physician/Supplier-Carrier setting that showed 91.68, 96.84, and 98.32,
and 99.13 percent of claims were final at 3, 6, 9, and 12 months,
respectively, following the date of service. At 24 and 48 months after
the date of service, 99.83 and 100 percent of the claims, respectively,
were final.
In the CY 2024 PFS proposed rule, we explained that based on our
evaluation of the 2010 claims data, a small percentage of lagged claims
data from a calendar quarter likely would not be available when the
quarter is first included on a report, and therefore we proposed that
annual reports (subsequent to the initial report) include lagged claims
data (that is, true-up information) for quarters from 2 calendar years
prior. In other words, we proposed that each report would include
information for 8 calendar quarters: 4 quarters from the previous
calendar year (hereafter, referred to as new refund quarters) and 4
quarters from 2 calendar years prior (hereafter, referred to as updated
refund quarters). See Table 20, which shows which refund quarters will
be in each refund report. We proposed all reports (except the initial
refund report) would include the following information for updated
refund quarters to address lagged claims data:
The updated total number of units of the billing and
payment code of such drug, if any, that were discarded during such
updated refund quarter, as determined using a mechanism such as the JW
modifier used as of the date of enactment of this subsection (or any
such successor modifier that includes such data as determined
appropriate by the Secretary).
The updated refund amount that the manufacturer is liable
for with respect to such updated quarter that was not previously
accounted for in the prior year's report.
For example, as discussed above, the second annual report (sent no
later than September 30, 2025) would include: (1) the total number of
units of the billing and payment code of such drug, if any, that were
discarded during new refund quarters (all calendar quarters in 2024),
(2) the refund amount for which the manufacturer is liable under
section 1847A(h)(3) of the Act for all calendar quarters in 2024, (3)
the updated total number of units of the billing and payment code of
such drug, if any, that were discarded during the updated refund
quarters (all calendar quarters in 2023), and (4) the refund amount
that the manufacturer is liable for or the amount CMS owes the
manufacturer under section 1847A(h)(3) of the Act for all calendar
quarters in 2023 that were not accounted for in the previous year's
report.
[GRAPHIC] [TIFF OMITTED] TR16NO23.041
We proposed to define ``new refund quarter'' and ``updated refund
quarter'' at Sec. 414.902 and to revise Sec. 414.940(a)(1)(iii) to
reflect the inclusion of lagged data in reports subsequent to the
initial refund report. We solicited comments on these proposals (88 FR
52389). See section III.A.3.d. of this final rule for the discussion
regarding calculation of refund amounts and for updated refund
quarters.
We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: Several commenters expressed support for the proposal to
align timing of discarded drug refund reports, beginning with the
second refund report, with inflation rebate reports.
Response: We thank the commenters for their support.
Comment: Two commenters opposed inclusion of more than one quarter
of lagged claims data for which manufacturers would be liable. One
commenter stated that since manufacturers are not responsible for
delays in claims submission, they should not bear the burden of refunds
on lagged claims. The other commenter stated that limiting lagged data
to one quarter would provide a better balance of administrative burden
and the accuracy of discarded amount assessments.
Response: We thank the commenters for their feedback. We disagree
that discarded amounts of refundable drugs for claims properly
submitted to Medicare contractors should not be considered for the
calculation of discarded drug refund obligations. Under 42 CFR 424.44,
providers and suppliers generally have one calendar year after the date
of service to submit claims, and the process by which contractors
review and finalize claims can sometimes take several additional
months.\150\ To accurately determine the number of discarded units in a
given quarter, the reconciliation of discard amounts for each quarter
one year after discard amount information is initially reported
provides an operational process that more accurately determines
discarded amounts and refunds for each quarter as compared to the
accuracy of such information if updated refund quarters were not
included in the reports.
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\150\ https://www.ecfr.gov/current/title-42/section-424.44.
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[[Page 79049]]
After considering the comments, we are finalizing the definitions
of ``new refund quarter'' and ``updated refund quarter'' at Sec.
[thinsp]414.902, as proposed. We are also finalizing the inclusion of
four updated refund quarters (one calendar year) in reports subsequent
to the initial refund report at Sec. [thinsp]414.940(a)(1)(iii) as
proposed. With respect to timing of refund reports, we reiterate our
intent to provide refund reports as follows:
As discussed in the 2023 PFS final rule at 87 FR 69726, we
intend to send a preliminary refund report to manufacturers no later
than December 31, 2023 to provide estimated discarded amounts based on
available claims data from the first 2 quarters of CY 2023;
We intend to send the initial refund report to
manufacturers not later than December 31, 2024, which will contain
information for all calendar quarters of 2023; and
For subsequent years, we intend to send annual refund
reports for discarded drug refunds for the 4 quarters from the previous
calendar year (new refund quarters) and 4 quarters from 2 calendar
years prior (updated refund quarters) prior to or around the time we
plan to send Part B inflation rebate reports for the first quarter of
the following year (not later than September 30).
c. Manufacturer Provision of Refund
In the CY 2023 PFS final rule (87 FR 69726 through 69727) we
adopted Sec. 414.940(b), which requires manufacturers to pay refunds
in 12-month intervals in a form and manner specified by CMS. In the CY
2023 PFS final rule (87 FR 69727), we also discussed our proposal for
the timing of both the initial refund report and manufacturers'
corresponding refund obligations. That is, we proposed to issue reports
to manufacturers by October 1 and require refund obligations to be paid
by December 31, except in circumstances where a dispute is pending.
Regulations at Sec. 414.940(b)(2) specify that in the case that a
disputed report results in a refund amount due, that amount must be
paid no later than 30 days after resolution of the dispute.
However, we did not finalize the deadlines by which manufacturer
refund obligations are due and those associated with the dispute
resolution process in the CY 2023 PFS final rule, because those
deadlines correspond with the dates of the annual refund reports, which
we declined to finalize in order to align the operation of the
discarded drug refunds with the inflation rebate programs. In the CY
2023 PFS final rule (87 FR 69727), we stated our intent to revisit the
process and timeline for manufacturers' provisions of refunds in future
rulemaking.
In the CY 2024 PFS proposed rule (88 FR 52389), we proposed to
issue the initial refund report to manufacturers no later than December
31, 2024. As discussed above, we are finalizing this policy. We
explained that a payment deadline that is 2 calendar months after the
issuance of the report may provide adequate time for manufacturers to
review the reports and submit a dispute if needed prior to the refund
payment deadline. Accordingly, we proposed to require that the refund
amounts specified in the initial refund report be paid no later than
February 28, 2025, except in circumstances where a report is under
dispute.
We also noted the proposal regarding issuance of the second annual
refund report to manufacturers be no later than September 30, 2025, and
once annually thereafter no later than September 30 for every year
thereafter. We contemplated this deadline along with our belief that a
payment deadline that is 2 calendar months after the issuance of the
report provides adequate time for manufacturers to review the reports
and submit a dispute if needed prior to the refund payment deadline.
Accordingly, we proposed to require manufacturers to pay refunds
specified in each report (beginning with the second report) no later
than December 31 of the year in which the report is sent, except in
circumstances where a report is under dispute. In cases in which a
manufacturer disputes a report, we proposed that beginning with the
initial refund report, any manufacturer liability determined upon the
resolution of the dispute would be due by the above stated due date or
30 days following the resolution, whichever is later. We proposed to
revise Sec. 414.940(b)(1) and (2) to reflect these dates.
We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: Two commenters expressed support for the payment timeline
of liabilities for circumstances in which there is no dispute, as well
as circumstances where there is a dispute with the extended deadline.
Response: We thank the commenters for their support.
Comment: One commenter stated that CMS's implementation of section
1847A(h) of the Act violates the due process principle of fair notice
because it attaches new legal consequences to decisions made in
compliance with applicable laws and regulations, such as the
determination of vial sizes, prior to enactment of the Infrastructure
Act. The commenter asserted their belief that neither Congress nor
agencies may impose retroactive penalties unless there is express
legislative authorization, which they stated does not appear in the
statutory provision for the discarded drug refund policy.
Response: Legislative recommendations for Congress are outside of
the scope of this rulemaking. As these policies affect refunds that
will be paid in the future after the promulgation of the rule, we
disagree that our proposed implementation of section 1847A(h) of the
Act violates the due process principle of fair notice. There are no
retroactive effects on payments that have already been made.
After consideration of public comments, we are finalizing revisions
to Sec. 414.940(b)(1) as proposed. That is, refund amounts specified
in the initial refund report for calendar quarters in CY 2023 must be
paid no later than February 28, 2025, and for calendar quarters in each
subsequent calendar year, no later than December 31 of the year in
which the report is sent, except in circumstances where a report is
under dispute. Regarding cases in which a manufacturer disputes a
refund report, we are finalizing revisions to Sec. 414.940(b)(2) as
proposed to reflect that any refund amounts determined upon the
resolution of the dispute will be due by the due date specified in
Sec. 414.940(b)(1) or 30 days following the resolution, whichever is
later.
d. Refund Amount
(1) Calculation of Refund Amounts for Updated Quarters
In the CY 2024 PFS proposed rule (88 FR 52389 through 52390) we
explained how we would calculate the refund amount for updated quarters
since we need to contemplate lagged claims data in all reports other
than the initial refund report. That is, we proposed that such
additional lagged JW modifier data, if any, will be used to calculate
revisions to the manufacturer refund amount. Specifically, we proposed
to calculate the refund with updated data in the same manner as was
finalized in the 2023 PFS final rule (87 FR 69727) and subtract the
refund amount that already paid for such refundable drug for such
quarter to determine the updated quarter refund amount. We proposed
that the refund amount owed by a manufacturer, with respect to a
refundable drug assigned to a billing and payment code for an updated
refund quarter is the amount equal to the estimated amount (if any) by
which:
The product of:
[[Page 79050]]
++ The total number of units of the billing and payment code for
such drug that were discarded during such quarter; and
++ The amount of payment determined for such drug or biological
under section 1847A(b)(1)(B) or (C) of the Act, as applicable, for such
quarter.
Exceeds the difference of:
++ An amount equal to the applicable percentage of the estimated
total allowed charges for such a drug (less the amount paid for
packaged drugs) during the quarter; and
++ The refund amount previously paid for such refundable drug for
the given quarter.
We proposed that if the resulting refund calculation for an updated
quarter is a negative number, then it will be netted out of the any
refund owed for other updated quarters or new quarters.
We proposed to revise Sec. [thinsp]414.940 by adding new
paragraphs (c)(2) and (3) to reflect the proposed method of calculation
of revisions to the refund amount owed for quarters in the year that is
2 calendar years prior.
We received one public comment on these proposals. The following is
a summary of the comment we received and our response.
Comment: One commenter expressed support for our proposal to use
the same refund calculation methodology for new and updated quarters'
claims data. The commenter stated the use of a consistent methodology
will provide manufacturers predictability.
Response: We appreciate the commenter's feedback.
After consideration of public comments, we are finalizing revision
of Sec. [thinsp]414.940 by adding paragraphs (c)(2) and (3), as
proposed, to reflect the method of calculation of revisions to the
refund amount owed for quarters in the year that is 2 calendar years
prior. That is, we will calculate the refund with updated data in the
same manner as described above and subtract the refund amount already
paid for such refundable drug, for such quarter, to determine the
updated quarter refund amount owed by the manufacturer.
(2) Calculation of Refund for a Drug When There are Multiple
Manufacturers
In the CY 2023 PFS final rule (87 FR 69727 through 69731),
consistent with section 1847A(h)(3) of the Act, we adopted regulations
at Sec. 414.940(c) specifying the manner in which the refund amount
will be calculated with respect to a refundable drug of a manufacturer
assigned to a billing and payment code for a calendar quarter beginning
on or after January 1, 2023. The refund for which the manufacturer is
liable is the amount equal to the estimated amount (if any) by which:
The product of:
++ The total number of units of the billing and payment code for
such drug that were discarded during such quarter; and
++ The amount of payment determined for such drug or biological
under section 1847A(b)(1)(B) or (C) of the Act, as applicable, for such
quarter;
Exceeds an amount equal to the applicable percentage of
the estimated total allowed charges for such a drug (less the amount
paid for packaged drugs) during the quarter.
In the CY 2023 PFS final rule, we proposed a policy to estimate the
total allowed charges during the quarter by multiplying the drug's
payment amount for the quarter by the total number of units of the
billing and payment code of such drug that were subject to JW modifier
reporting including those for which the JZ modifier would be required
if no units were discarded. As specified in section 1847A(h)(1)(C) of
the Act, the total number of units of the billing and payment code of a
refundable drug furnished during a calendar quarter for purposes of
subparagraph (A)(i), and the determination of the estimated total
allowed charges for the drug in the quarter for purposes of paragraph
(3)(A)(ii), exclude such units that are packaged into the payment
amount for an item or service and are not separately payable.
In the CY 2024 PFS proposed rule (88 FR 52390 through 52391) we
discussed situations where single source drugs or biologicals have
multiple manufacturers. We explained that because refundable drugs are
single source drugs or biologicals, they typically will have one
manufacturer. However, a refundable drug could have more than one
manufacturer, for example, in the circumstance where a refundable drug
is produced by one manufacturer, and also by one or more
manufacturer(s) that is a repackager or relabeler. Multiple
manufacturers of a refundable drug could also occur in the case of one
or more authorized generic products that are marketed under the same
FDA-approval as the original FDA applicant. In such cases, the National
Drug Codes (NDCs) for the drug typically are assigned to the same
billing and payment code, and each manufacturer is responsible for
reporting ASP data to CMS, which includes sales volume.
In the CY 2023 PFS final rule (87 FR 69724 through 69726), we
stated that we would identify the manufacturer responsible for the
provision of refunds by the labeler code of the refundable drug.
Therefore, in the CY 2024 PFS proposed rule, we discussed our proposal
to establish a method for apportioning billing units of a refundable
drug sold during a calendar quarter in situations where there are
multiple manufacturers of a refundable drug. When calculating the
refund amount owed by manufacturers for a refundable drug that has more
than one manufacturer, we proposed to identify such refundable drugs
using the ASP sales data reported for the calendar quarter for which a
refund amount is calculated. Furthermore, we proposed to apportion
financial responsibility for the refund amount among each manufacturer
in the following manner: by dividing the sum of the individual
manufacturer's billing units sold during the refund quarter for all the
manufacturer's NDCs assigned to the billing and payment code (as
reported in the ASP data submissions), by the sum of all manufacturers'
billing units sold during the refund quarter for all NDCs of the
refundable drug assigned to the billing and payment code (as reported
in the ASP data submissions).
We explained that this calculation approach is consistent with the
approach for apportioning inflation rebate obligations discussed in
section 50.13 of the Medicare Part B Drug Inflation Rebates Paid by
Manufacturers: Initial Memorandum, Implementation of Section 1847A(i)
of the Social Security Act, and Solicitation of Comments,\151\ released
on February 9, 2023.
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\151\ https://www.cms.gov/files/document/medicare-part-b-inflation-rebate-program-initial-guidance.pdf.
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In addition, we proposed to apportion the discarded drug refund
when there is more than one manufacturer for a refundable drug, using
the proportion of billing unit sales, expressed as a percentage,
attributed to each NDC (at the NDC-11 level) assigned to the billing
and payment code for such refund quarter. The number of billing unit
sales for each NDC would be the reported number of NDCs sold (as
submitted in the ASP report to CMS each quarter) multiplied by the
billing units per package for such NDC. We proposed that the refund
amount attributed to such NDCs for which the manufacturer is liable
would be the amount equal to the estimated amount (if any) by which:
The product of:
++ The total number of units of the billing and payment code for
such drug that were discarded during such quarter;
[[Page 79051]]
++ The percentage of billing unit sales of the applicable code
attributed to the NDC; and
++ The amount of payment determined for such drug or biological
under section 1847A(b)(1)(B) or (C) of the Act, as applicable, for such
quarter;
Exceeds an amount equal to the product of:
++ The applicable percentage of the estimated total allowed charges
for such a drug (less the amount paid for packaged drugs) during the
quarter; and
++ The percentage of billing unit sales of the applicable code
attributed to the NDC.
For example, if a billing and payment code for a refundable drug
includes three NDCs, each from a different manufacturer as shown in
Table 21, there were 3,000 units discarded during the refund quarter
out of 21,000 total billing units of a billing and payment code
administered, the payment limit amount for the refundable drug was
$50.00 per billing unit, the applicable percentage was 10 percent, and
the estimated total allowed charges for the refundable drug during the
refund quarter was $1.05 million, the proposed calculation for the
refund amount owed by Manufacturer 1, which reported 23.81% of billing
unit sales for the billing and payment code for the refund quarter,
would be as follows: (3,000)(23.81%)($50)-(21,000)(10%)(23.81%)($50) =
refund amount of $10,714.50.
[GRAPHIC] [TIFF OMITTED] TR16NO23.042
Using this example and following the proposed calculation, the
report to manufacturers, discussed above in section III.A.3.b of this
final rule, would include: (1) the total number units of the billing
and payment code of such drug attributed to the manufacturer's NDC
assigned to the billing and payment code of the refundable drug that
were discarded during such quarter, if any; and (2) the refund amount
for which the manufacturer of that NDC is liable under section
1847A(h)(3) of the Act. We proposed that this method of calculation
apply beginning with calendar quarters in CY 2023 included in the
initial refund report, which, as described in section III.A.3.b in this
final rule, we are finalizing be sent no later than December 31, 2024.
We proposed that this method of calculation will be done for new refund
quarters and updated refund quarters.
We proposed to revise Sec. [thinsp]414.940 by adding a new
paragraph (c)(4) to reflect the above proposed method of calculation of
the refund amount attributed to a NDC when there are multiple
manufacturers.
We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: Two commenters expressed support of the proposed
methodology for calculating the refund for drugs with multiple
manufacturers.
Response: We thank the commenters for their support.
Comment: Two commenters opposed the proposed methodology because
they claim that the calculation could result in a manufacturer owing a
discarded drug refund even if the amounts discarded from the
manufacturer's refundable drugs did not exceed the applicable
percentage. One commenter urged CMS to ensure that Part B claims data
correctly indicate the specific products prescribed and administered to
patients. Commenters stated that each manufacturer's refund liability
should only be determined based on that manufacturer's product. The
commenters also stated that the statute precludes our methodology, as
it states that ``a refund . . . [shall be] equal to the amount
specified in paragraph (3) for such drug for such quarter.'' The
commenters state that the discarded drug refund should be calculated at
the NDC-11 level if a refund is due for a refundable drug when there
are multiple manufacturers of such drug. One commenter states that the
plain language of section 1847A(h) of the Act requires CMS to implement
a process that precisely identifies refund liability based on each
manufacturer's refundable drug. In such a case, CMS should develop a
process to require reporting of NDC-11s on the CMS-1500 and 837P claim
forms and reject as incomplete any forms without required NDC-11s.
Another commenter urged CMS to assure that refund reports are accurate
with respect to manufacturers that owe them.
Response: We thank commenters for their input. In considering the
issues raised by commenters about manufacturers owing refunds that they
assert should be the responsibility of other manufacturers, we
considered the proposed methodology for calculating the refund using
actual data. To that end, we identified 12 refundable drugs with
multiple manufacturers and found that in a vast majority of these
cases, each manufacturer is packaging the product in the same sized
container(s). We found one instance where a repackager manufactures two
of the four package sizes available from the other manufacturer of the
refundable drug, but the repackager did not produce any product sizes
that were not also produced by the other manufacturer.
Based on this analysis showing that the available product size(s)
are typically the same or very similar between manufacturers (when
there is more than one manufacturer for a refundable drug), it is
unlikely that the discarded amounts from such package sizes would be
significantly different. In addition, we do not have data that certain
NDCs of a refundable drug from one manufacturer would be furnished to
Medicare beneficiaries more often than another manufacturer when such a
drug has more than one manufacturer. Therefore, we are not convinced
that the proposed methodology for calculating the refund would result
in one manufacturer owing any significant amount of refund that would
have been owed by the other manufacturer because we expect discarded
amounts to be the same in nearly all instances in which a product is
used from the same size containers (with same labeled amount of drug)
regardless of who is
[[Page 79052]]
manufacturing the product. For example, we would expect a vial
containing 1 mg of a drug to have, on average, the same discarded
amount as another vial containing 1 mg of the same drug (under the same
approval, such as an NDA or BLA), even if it is from a different
manufacturer. As this policy is operationalized, CMS will monitor
report information for refundable drugs with multiple manufacturers. We
welcome input and data from manufacturers and may address this issue
further in future rulemaking, if appropriate.
We thank the commenter for suggesting the requirement that NDC-11
should be required on claims forms to facilitate accurate calculation
of the refund, however, this is out of the scope of this proposal.
After reviewing public comments, we are finalizing the revision to
Sec. [thinsp]414.940 by adding (c)(4), as proposed, to reflect the
method of calculation of the refund amount attributed to a NDC when
there are multiple manufacturers of a refundable drug. We clarify that
the sales quarter of the ASP data used for this method of calculation
will align with the dates of service for a new refund quarter or
updated refund quarter. For example, calculation of refunds for the
first calendar quarter of 2023 will use ASP data that reflect sales
from that quarter. This data is reflected in the July ASP Drug Pricing
File because of the two-quarter lag between the sales quarter and when
that data is reflected in the ASP Drug Pricing File.
(3) Increased Applicable Percentage for Drugs With Unique Circumstances
Section 1847A(h)(3)(B)(ii) of the Act provides that, in the case of
a refundable drug that has unique circumstances involving similar loss
of product as that described in section 1847A(h)(8)(B)(ii) of the Act,
the Secretary may increase the applicable percentage otherwise
applicable as determined appropriate by the Secretary. In the CY 2023
PFS final rule (87 FR 69727 through 69731), we adopted an increased
applicable percentage of 35 percent for drugs reconstituted with a
hydrogel and with variable dosing based on patient-specific
characteristics (Sec. 414.490(d)(1)). We have identified only one
drug, Jelmyto[supreg] (mitomycin for pyelocalyceal solution), with such
unique circumstances. We stated in that final rule that we recognize
that there are drug products that may indeed have other unique
circumstances, and that an increased applicable percentage for these
products would have to be determined through future notice and comment
rulemaking, as required by the statutory provision. We stated that we
planned to collect additional information about drugs that may have
unique circumstances along with potential increased applicable
percentages that might be appropriate for such drugs, and to collect
additional information about a process to identify unique circumstances
based on manufacturer input. We explained that we would revisit
additional increased applicable percentages for drugs that have unique
circumstances, and a process to identify such circumstances, through
future notice and comment rulemaking. To that end, we hosted a town
hall meeting on February 1, 2023 to discuss what criteria would be
appropriate to determine whether a refundable drug has unique
circumstances, and whether a categorical approach (that is, unique
circumstances that apply to more than one drug), drug-by-drug approach,
or a hybrid of these two approaches should be used for determining
drugs for which an increased applicable percentage is appropriate.
In the CY 2024 PFS proposed rule (88 FR 52391 through 52395) we
explained that after considering input from interested parties provided
at the town hall and in subsequent meetings, we proposed a hybrid
approach to determining when it is appropriate to increase the
applicable percentage for a drug with unique circumstances. First, we
proposed two unique circumstances along with proposed increased
applicable percentages and, secondly, we proposed an application
process so manufacturers may request that CMS consider whether an
increased applicable percentage would be appropriate for a particular
drug in light of its unique circumstances (and if an increased
applicable percentage is considered appropriate it would then be
proposed in future notice-and-comment rulemaking).
We noted that we discussed in the CY 2023 PFS final rule and
further at the town hall, the many requests from interested parties for
CMS to increase applicable percentages (defined at Sec.
[thinsp]414.940(c)(3) as 10 percent, except where an increased
applicable percentage is applied in paragraph (d) of that section) for
drugs packaged with small vial fill amounts or low-volume products
(generally, those with a fill amount less than 1 mL). These parties
stated that, for certain drugs, the small volume of drug contained in
the vial (as identified on the package or FDA labeling) often
represents the minimum volume necessary to safely and effectively
prepare and administer the prescribed dose. Certain labeled amounts
that are unused and discarded include amounts remaining in the syringe
hub, amounts remaining in the syringe that are not part of the
prescribed dose, amounts left in the vial that cannot be removed (such
as drug adhering to the side of the vial or pooling around the vial
stopper), and amounts left in the vial when it contains enough drug for
two administration attempts.
We agreed that such drugs have unique circumstances, because
certain FDA-labeled amounts on the vial or package are unused and
discarded after administration of the labeled dose and these amounts
are not available to be administered. The unique circumstances
described for such drugs are similar to loss of product from filtration
described in section 1847A(h)(8)(B)(ii) of the Act because in both
circumstances, such amounts lost are amounts that are not part of the
recommended dose and are not available to be administered to the
patient (one being loss due to labeled amounts remaining in the filter
and the other due to labeled amounts remaining in other areas such as
the vial or syringe).
Since not all drugs with small fill volumes have certain labeled
amounts that are unused and discarded, we believed more specific
criteria are required to identify certain drugs with unique
circumstances in this case. For example, if a drug is available as 0.8
mL in a prefilled syringe, the total volume in the presentation is
small, however, the entire labeled amount in the syringe may be
administered to the patient as part of a labeled dose; the unique
circumstances described above only occur when the volume of the labeled
dose that is withdrawn from a vial or container is very small and there
is a labeled amount that is unused and discarded and not available for
administration (based on drugs currently available in the market, we
have observed this to occur with doses contained within less than 0.4
mL). Therefore, we proposed an increased applicable percentage for
drugs with a ``low volume dose.'' We considered a low volume dose to be
a dose of a drug for which the volume removed from the vial containing
the labeled dose does not exceed 0.4 mL (which is about 8 drops of
liquid). We proposed to revise Sec. 414.902 and define a low volume
dose to be a labeled dose (based on FDA-approved labeling) that is
contained within no more than 0.4 mL when removed from the vial or
container. For example, if a labeled dose is 4 mg and a vial contains a
suspension with a concentration of 40 mg/mL, the labeled
[[Page 79053]]
dose will be contained in 0.1 mL, which will not exceed 0.4 mL and
will, therefore, be considered a low volume dose. We proposed that this
definition of low volume dose apply even if the drug is further diluted
after removal from the vial and prior to administration because, even
if the dose is further diluted, a dose withdrawn from the vial and
diluted would still have the same physical constraints as a dose that
was not diluted, and those constraints would necessitate the loss of
product as described in the previous paragraph. In addition, we
proposed that for a drug to meet these unique circumstances, all
labeled doses of the drug would be low volume doses. We explained, as
proposed, this definition would not affect the determination of units
as defined at section 1847A(b)(2)(B) of the Act and codified at Sec.
414.802, and we note that the statutory definition of unit is exclusive
of any diluent without reference to volume measures pertaining to
liquids. We also explained that the proposed definition of low volume
dose would only be applied for the determination of whether a higher
applicable percentage is warranted for a drug.
We proposed a two-tiered increased applicable percentage for drugs
with low volume doses, because the percentage that is unused and
discarded for these drugs decreases as the volume of the dose
increases. We proposed that, for drugs with labeled doses contained
within 0.1 mL or less when removed from the vial or container, the
applicable percentage be increased to 90 percent. We proposed 90
percent applicable percentage for this tier because certain drugs with
low volume doses of 0.1 mL or less have up to 90 percent of the labeled
amount that is unused and discarded and not part of the labeled dose
available to be administered.152 153 We explained that we
did not propose to add an additional 10 percent to this number as we
did in the case of hydrogel, as discussed in the CY 2023 final rule
(see 87 FR 69729), because, generally, we do not believe it would be
appropriate for any product to have an applicable percentage of 100
percent. Such an applicable percentage would, in effect, exclude drugs
from the refund liability altogether. We believe it would be
inappropriate to effectively expand the list of exclusions described in
section 1847A(h)(8)(B) of the Act by proposing an increased applicable
percentage of 100 percent to drugs not expressly excluded in statute.
However, we considered whether some additional percentage might be
appropriate in this case. We solicited comment on whether an additional
percentage above 90 percent (but less than 100 percent) is warranted
for drugs with low volume doses of 0.1 mL or less.
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As we discussed in the CY 2024 PFS proposed rule (88 FR 52392), in
the second tier of the low volume dose unique circumstances, we
proposed that for drugs with labeled doses contained within 0.11-0.4
mL, the applicable percentage be increased to 45 percent. Certain drugs
currently marketed that fall into this category have up to 35.6 percent
of the labeled amount that is unused and discarded and not part of the
labeled dose to be administered. In the same manner as the applicable
percentage for the hydrogel finalized in the CY 2023 PFS final rule, we
proposed to add the discarded amount percentage to the applicable
percentage of 10 percent that is used for drugs without unique
circumstances (that is, 35.6 percent plus 10 percent), and we proposed
to round that number to an applicable percentage of 45 percent for this
tier.
In summary, we proposed to increase the applicable percentages for
drugs with a low volume dose (a dose of a drug for which the volume
removed from the vial or container containing the labeled dose does not
exceed 0.4 mL). Specifically, we proposed that:
Refundable drugs with labeled doses that are contained
within 0.1 mL or less when removed from the vial or container have an
increased applicable percentage of 90 percent and;
Refundable drugs with labeled doses that are contained
within 0.11-0.4 mL when removed from the vial or container have an
increased applicable percentage of 45 percent.
To date, we have identified certain drugs that would meet the
proposed criteria for such unique circumstances and would have a
proposed increased applicable percentage of 90 percent, including
Triesence[supreg] (triamcinolone acetonide injection, suspension) and
Xipere[supreg] (triamcinolone acetonide injection, suspension), along
with some other ophthalmic drugs with such low volume doses that do not
include all of the target fill volume in the labeled amount (that is,
those that are labeled such that the low volume dose is equal to the
labeled amount). We also noted that, although SusvimoTM
(ranibizumab injection, solution) would qualify for the proposed 90
percent applicable percentage, it is excluded from the definition of
refundable drug due to filtration requirements as discussed in the CY
2023 PFS final rule (87 FR 69723 through 69724). To date, we have
identified certain drugs that would meet the proposed criteria for such
unique circumstances and would have a proposed increased applicable
percentage of 45 percent, including Xiaflex[supreg] (collagenase
clostridium histolyticum) and Kimmtrak[supreg] (tebentafusp injection,
solution, concentrate).
In the CY 2023 PFS proposed rule (88 FR 52392 through 52393), we
discussed that the second proposed unique circumstances is for orphan
drugs administered to a low volume of unique beneficiaries, which we
proposed to be fewer than 100 unique Medicare fee-for-service
beneficiaries per calendar year (hereafter referred to as rarely
utilized orphan drugs); we proposed an increased applicable percentage
of 26 percent for drugs with these unique circumstances. We explained
that there is a higher probability that the percentage of discarded
amounts for rarely utilized orphan drugs may not have a normal
statistical distribution from quarter to quarter, which could
disproportionately affect manufacturers of such drugs by resulting in
highly variable refund amounts as compared with the variability of
drugs administered to a higher number of beneficiaries. This is
evidenced by our analysis of quarterly discarded drug data reported
using the JW modifier of 30 refundable drugs identified in the 2021
Medicare Part B Discarded Drug Units data with greater than 10 percent
units discarded,\154\ three of which were orphan drugs furnished to a
patient population of less than 100 unique fee-for-service Medicare
beneficiaries in CY 2021: J9262 (omacetaxine mepesuccinate); J9269
(tagraxofusp-erzs); and J0223 (givosiran). For these drugs identified
in the 2021 Medicare Part B Discarded Drug Units data, we analyzed JW
modifier data for quarters in 2021 and 2022, which showed that the
average standard deviation of the percentage of units discarded across
quarters for the rarely utilized orphan drugs is 6.21 percent, compared
with an average standard deviation for all other refundable drugs (with
a percentage of discarded units over 10 percent in 2021) of 2.35
percent. In other words, the standard deviation from the mean discarded
drug percentage for rarely utilized orphan drugs is 2.64 times greater
than that of the group of refundable drugs with larger patient
populations and claims volume. In
[[Page 79054]]
addition, of the three aforementioned drugs, the most public data is
associated with J9262, which shows that the percent discarded units for
J9262 was 23.65 percent, 19.96 percent, and 30.98 percent in 2019,
2020, and 2021, respectively. Because of this substantial statistical
variation from quarter to quarter for such drugs, we believe it would
be difficult to optimize the presentation of the drug to consistently
minimize the discarded amounts to less than 10 percent given the small
number of patients receiving the drug. We considered the higher
percentage of unused and discarded amounts from such drugs as
unavoidable loss due to both the low volume of unique beneficiaries
receiving the drug contributing statistically higher variability in
discarded amounts. Also, due to the low numbers of patients available
to study for rare disease, it may be more difficult to determine the
most efficient vial size for the patient population who receive the
drug post-marketing. We stated this is similar to the loss of product
due to filtration described in section 1847A(8)(B)(ii) of the Act
because the loss is unavoidable in both circumstances. In the case of
filtration described in statute, the loss is unavoidable because
certain amounts of product will be left within the filter and
unavailable for administration; in the case of rarely utilized orphan
drugs, the loss is unavoidable because of the variability of potential
doses (and low number of patients receiving the drug) leading to an
inability to develop a package size that will result in a consistent
average percentage of discarded units (as evidenced in the analysis
above in this section). In contrast, drugs administered to a larger
number of beneficiaries per year have a more consistent average
percentage discarded from quarter to quarter, as evidenced by the lower
standard deviation in our analysis, and we believe manufacturers are
able to develop availability of the drug accordingly to minimize
discarded amounts.
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We proposed that unique circumstances of rarely utilized orphan
drugs have the following characteristics: (1) a drug designated under
section 526 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as a
drug for a rare disease or condition; and (2) that is furnished to
fewer than 100 unique Medicare fee-for-service beneficiaries per
calendar year. We proposed that the number of beneficiaries receiving
such drug in the calendar year would correspond with the refund
quarter. For example, for refund quarters in 2023, we would use the
number of beneficiaries receiving the drug in the 2023 calendar year to
determine if the unique circumstances and increased applicable
percentage would apply. Data of number of beneficiaries would be
analyzed at the same time as the JW modifier data for the given
calendar quarters. To meet these unique circumstances, we proposed that
the drug be designated an orphan-drug under section 526 of the FD&C Act
for a rare disease or condition (or diseases or conditions) and be
approved by the FDA only for a designated rare disease or condition (or
diseases or conditions). That is, all FDA-labeled indications for the
drug must be orphan indications, and if the drug has one or more
indications that are for conditions that are not designated by the FDA
to be a rare disease or condition, the drug would not be considered to
have unique circumstances of rarely utilized orphan drugs. In addition,
we proposed that the drug would meet these unique circumstances and
that the increased applicable percentage would apply for as long as the
drug meets these conditions, even after any orphan drug exclusivity end
date.
The increased applicable percentage of 26 percent that we proposed
is appropriate because the standard deviation from the mean discarded
drug percentage for rarely utilized orphan drugs is 2.64 times greater
than that of the larger group of refundable drugs, and multiplying the
applicable percentage referenced in paragraph (h)(3)(B)(i)(II) by how
many times greater the variance is (in other words, 10 percent times
2.64) equals 26.4 percent, which we proposed to round to the nearest
percentage.
We proposed that we will identify drugs that have unique
circumstances of low volume doses and rarely utilized orphan drugs in
the report sent to manufacturers and apply the proposed increased
applicable percentages based on these unique circumstances proposals.
If a manufacturer believes that the incorrect applicable percentage was
applied to the refund calculation, the manufacturer may submit a
dispute regarding the calculation by submitting an error report (see
Sec. [thinsp]414.940(e)).
We proposed to codify these applicable percentages at Sec.
[thinsp]414.940(d). Specifically, we proposed to add applicable
percentages for low volume doses by creating new paragraphs (d)(3) and
(4); and we proposed to add applicable percentage for orphan drugs
administered to fewer than 100 unique beneficiaries per calendar year
in new paragraph (d)(5). We proposed that these applicable percentages
apply beginning with the initial refund report that we proposed to be
sent no later than December 31, 2024.
We solicited comments on the proposed unique circumstances.
Specifically, we solicited comment on the proposed volume (mL) tiers
for drugs with low volume doses along with the proposed increased
applicable percentages and whether an additional percentage above 90
percent (but less than 100 percent) is warranted for drugs with low
volume doses of 0.1 mL or less. We also solicited comment on the
increased applicable percentage of 26 percent for rarely utilized
orphan drugs.
We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: Several commenters supported the proposed unique
circumstances and increased applicable percentages. One commenter
expressed general support for the expansion of the scope of drugs that
may be considered to have unique circumstances and be considered for an
increased applicable percentage.
Several commenters expressed support for the proposed unique
circumstances and increased applicable percentage for small volume
drugs, some specifically supporting the increase applicable percentage
of 90 percent for drugs with low volume doses of 0.1 mL or less and
others specifically supporting the increased applicable percentage of
45 percent for drugs with low volume doses of 0.11--0.4 mL. One
commenter stated that low volume dose drugs are particularly
susceptible to having unusable product that remains after the product
is administered. This commenter also expressed support of the tiered
increased applicable percentage and agreed that the percentage of
unusable amounts decreases as product volume increases. Another
commenter added that without an increased applicable percentage for
small volume drugs, as proposed, the discarded drug refund policy would
lead to underdosing of anti-vascular endothelial growth factor (anti-
VEGF) therapies used to treat age-related macular degeneration (AMD),
diabetic retinopathy, and other vision-threatening retinal diseases.
One commenter expressed support for the clarification that
SusvimoTM (ranibizumab injection for intravitreal use via
ocular implant) would have a proposed applicable percentage of 90
percent if it were not already excluded due to filtration requirements.
Several commenters support the proposed increased applicable
percentage for rarely utilized orphan
[[Page 79055]]
drugs. Other commenters stated they generally support the proposal
regarding orphan drugs and the increased flexibility of the proposal.
Two commenters expressed support for the proposed increased applicable
percentage of 26 percent and agree that rarely utilized orphan drugs
possibly have high discarded amounts due to limited manufacturing
capability.
Response: We thank these commenters for their support of these
proposals.
Comment: One commenter stated that drug low volume doses with 0.1
mL or less should have an increased applicable percentage of 100
percent, which would effectively exempt such drugs from liability for
any discarded drug refund. The commenter stated, to the extent that the
purpose of this provision is to encourage manufacturers to adopt
packaging that is appropriately sized to the dose, drugs with low
volume doses of 0.1 mL or less have already met the objective to
minimize discarded amounts. Another commenter requested an increased
applicable percentage of 100 percent for drugs with a volume of 1 mL or
less. This commenter stated that discarded drug modifiers add
administrative burden for intravitreal, single-use drugs.
Response: As discussed above in this section, we do not believe it
would be appropriate for any product to have an applicable percentage
of 100 percent. Such an applicable percentage would, in effect, exclude
drugs from the refund liability altogether. We believe it would be
inappropriate to effectively expand the list of exclusions described in
section 1847A(h)(8)(B) of the Act by proposing an increased applicable
percentage of 100 percent to drugs not excluded in statute. With regard
to the burden of the JW and JZ modifiers, we stated in the CY 2023 PFS
final rule (87 FR 69724) that even if a drug is excluded from the
definition of refundable drug (and not subject to refunds), for
example, multiple source drugs, claims for such drugs furnished from a
single-dose container are still required to use the JW and JZ modifiers
in accordance with the policy. Therefore, even if CMS were to increase
the applicable percentage of a drug to 100 percent, the drug would
still be subject to the JW and JZ modifier policy and the increased
applicable percentage would not relieve administrative burden.
Comment: Several commenters requested CMS clarify how we determined
the 100-beneficiary cutoff for rarely utilized orphan drugs and an
increased applicable percentage of 26 percent for drugs with these
unique circumstances. One commenter stated that the qualifying criteria
for rarely utilized orphan drugs is flawed and lacking details. Another
commenter stated that the rationale used for establishing unique
circumstances for rarely utilized orphan drugs could be applied to
orphan drugs that treat more than 100 Medicare fee-for-service
beneficiaries. One commenter noted that our initial proposal was
limited to the 30 drugs that had discarded drug amounts exceeding 10
percent in each of 2019, 2020 and 2021. One commenter explained that
the ten billing and payment codes for drugs with less than 100
beneficiaries are primarily prescribed to treat diseases for patients
under the age of 65. Further, the commenter pointed out two of the
three rarely utilized orphan drugs referenced in the proposed rule had
a majority of patients who were non-elderly in their studies.
Three commenters asked that CMS consider increasing the less than
100-beneficiary cutoff for a drug to qualify for the unique
circumstance. One commenter requested that we increase the beneficiary
threshold to 500 beneficiaries a year while another commenter suggested
increasing the threshold to 1,000 beneficiaries. One commenter supports
a more holistic orphan disease unique circumstances and thresholds in
line with current definitions of rare and ultra-rare diseases.
Some commenters ask that we consider if an increase that is higher
than the proposed 26 percent in the applicable percentage for rarely
utilized orphan drugs may be necessary. One commenter suggested CMS
exempt orphan drugs with a single indication from discarded drug refund
liability. The commenter explained that in 2022, these drugs accounted
for 1 percent of total Medicare FFS, an amount that doesn't justify the
high proportion of the total discarded refund liabilities that will be
imposed on orphan drugmakers. This commenter also proposed that,
alternatively, CMS could increase the applicable percentage to 35
percent (along with a beneficiary increase to 1,000 beneficiaries as
described above in this section).
Response: For unique circumstances of rarely utilized orphan drugs,
the 100-beneficiary threshold was a result of an analysis of quarterly
discarded drug data from 2021 and 2022. We explained in the proposed
rule that this analysis showed that there is a higher probability that
the percentage of discarded amounts for rarely utilized orphan drugs
may not have a normal statistical distribution from quarter to quarter,
which could disproportionately affect manufacturers of such drugs by
resulting in highly variable refund amounts as compared with the
variability of drugs administered to a higher number of beneficiaries.
The increased variability of the percentage of discarded amounts from
quarter to quarter was not observed for orphan drugs administered to
more than 100 unique beneficiaries per year. We explained that the
average standard deviation of the percentage of units discarded across
quarters for rarely utilized orphan drugs is 6.21 percent, compared
with an average standard deviation for all other refundable drugs (with
a percentage of discarded units over 10 percent in 2021) of 2.35
percent.
The justification for the unique circumstances in rarely utilized
orphan drugs hinges on the variability of percentage of discarded
amounts from quarter to quarter (not the actual percentage discarded
itself). The threshold of 100 beneficiaries per year for the unique
circumstances of rarely utilized orphan drugs is supported by this
sharp decrease in variability of discarded percentages when the drug is
administered to more than 100 unique beneficiaries. Such variability
from quarter to quarter is not observed when the number of
beneficiaries receiving the drug exceeds 100 per year. For example, the
percentage of discarded amounts for available quarters through the end
of CY 2022 for Elzonris[supreg] (tagraxofusp-erzs), which was
administered to 19 unique beneficiaries in 2021, ranges from a low of
6.55 percent to a high of 34.52 percent per quarter (a spread of 27.97
percent). In contrast, the percentage of discarded amounts for
Folotyn[supreg] (pralatrexate), which was administered to 155 unique
beneficiaries in 2021, ranges from a low of 9.04 percent to a high of
14.87 percent per quarter (spread of 5.83 percent). We evaluated
several other orphan drugs furnished to more than 100 beneficiaries and
all had low variability of the percentage discarded from quarter to
quarter.
The statutory provision requires that unique circumstances be
similar to the loss of product due to filtration described in section
1847A(8)(B)(ii) of the Act. We stated in the proposed rule that rarely
utilized orphan drugs have unique circumstances similar to filtration
described in section 1847A(8)(B)(ii) of the Act because the loss is
unavoidable in both circumstances. We stated that in the case of rarely
utilized orphan drugs, the loss is unavoidable because of the
variability of potential doses (and low number of patients receiving
the drug)
[[Page 79056]]
leading to an inability to develop a package size that will result in a
consistent average percentage of discarded units. We are not convinced
by commenters that an alternative threshold of 500 or 1,000
beneficiaries more closely ties the unique circumstances to filtration
described in section 1847A(8)(B)(ii) of the Act.
For justification of increased applicable percentage of 26 percent,
we explained in the proposed rule that the standard deviation from the
mean discarded drug percentage for rarely utilized orphan drugs is 2.64
times greater than that of the group of refundable drugs with larger
patient populations and claims volume. We multiplied the mean discarded
drug percentage by the applicable percentage of drugs without unique
circumstances (that is, 10 percent) to arrive at an increased
applicable percentage of 26 percent. Commenters did not provide
additional justification for their suggestions for an alternative
increased applicable percentage, and we are not convinced by these
comments that an alternative increased applicable percentage different
the proposed of 26 percent is appropriate for these unique
circumstances.
Comment: One commenter stated that there is a risk that basing
eligibility for being considered a rarely utilized orphan drug on a
single year could create unwarranted volatility as to whether the
unique circumstances apply in any given calendar year. The commenter
requested that the 100-beneficiary cutoff for the qualification of a
drug to be considered to have unique circumstances of a rarely utilized
orphan drug be determined using a 3-year rolling average.
Response: We agree with the commenter that a 3-year rolling average
is reasonable to determine eligibility for having the unique
circumstances of rarely utilized orphan drugs along with the increased
applicable percentage for these unique circumstances because this would
prevent volatility for determining whether these unique circumstances
apply to an orphan drug that is nearing the 100-beneficiary threshold.
Therefore, in this final rule, we are finalizing a modification to our
proposal such that for the purposes of determining whether a drug is a
rarely utilized orphan drug for which the applicable percentage would
be 26 percent, the drug will have met the condition of being furnished
to fewer than 100 unique Medicare fee-for-service beneficiaries per
calendar year if it meets one of the two conditions below:
(1) the number of unique beneficiaries to whom the drug is
furnished is less than 100 during the calendar year in which the refund
quarter occurs; or
(2) the average number of unique beneficiaries per year for the
calendar year in which the refund quarter occurs and the 2 previous
calendar years (3-year average) is less than 100. In the case that a
drug for which at least 2 but less than 3 years of data available, we
will calculate the average to determine whether the 100-beneficiary
threshold is met.
Comment: One commenter asked that we allow manufacturers to provide
feedback for potential future amendments to the criteria for these
unique circumstances for orphan drugs. The commenter stated that there
are manufacturers of orphan drugs with low patient volume that have
similar circumstances to those of the three rarely utilized orphan
drugs identified in the proposed rule. Specifically, the commenter
stated that manufacturers of other orphan drugs have difficulty
financially justifying creation of new vial sizes. One commenter
requested that we continue to periodically reassess whether the 100
unique beneficiary threshold is appropriate as new rare disease
therapies are developed.
Response: We welcome additional engagement on future policy
development regarding unique circumstances of rarely utilized orphan
drugs and their associated increased applicable percentage. We plan to
continue monitoring JW and JZ modifier data and variability of the
percentage discarded from quarter to quarter for orphan drugs to inform
potential future policy development.
Comment: One commenter recommended that CMS clarify how we
determine whether a particular drug is a low volume dose. The commenter
stated that clinicians administering drugs may not know the precise
amount of product contained in the vial or other container, in part
because the FDA label often does not indicate such amount. Therefore,
the commenter urged CMS not to depend on the clinician's own
interpretation to determine if a drug has a low volume dose. Instead,
the commenter suggested that CMS should maintain a list of drug
products with low-volume doses, and CMS should allow manufacturers to
submit information to CMS--including information not contained in the
FDA label, when necessary--to demonstrate that the low-volume threshold
is met. Another commenter requested we establish a process for
manufacturers to request and receive confirmation before a calendar
year begins whether their product has unique circumstances with an
increased applicable percentage. The commenter stated that such a
process would give manufacturers necessary notice whether a product was
considered to have unique circumstances.
Response: We agree with commenters that CMS should communicate
which drugs have been identified as meeting criteria for low volume
dose unique circumstances. In the proposed rule, we stated that we
would consider a low volume dose to be a dose of a drug for which the
volume removed from the vial containing the labeled dose does not
exceed 0.4 mL. In addition, we proposed that for a drug to meet these
unique circumstances, all labeled doses of the drug must be low volume
doses. Although all the necessary information is available in the FDA-
approved labeling to determine if a drug has a low volume dose, we
agree that this information may not be explicitly stated in FDA-
approved labeling, and we agree that maintaining a list of drugs
identified as having low volume doses will help provide clear
communication of which drugs have these unique circumstances.
Therefore, we intend to publish a list of drugs CMS has identified as
having low volume doses and will have an increased applicable
percentage no later than December 31, 2023, and intend to update the
list no later than December 31 of each subsequent year. This would
allow adequate time for manufacturers to evaluate the list prior to the
deadline of February 1 for the application process for increased
applicable percentage.
Similarly, we considered providing similar advance notice for
rarely utilized orphan drug unique circumstances. However, the number
of beneficiaries receiving the drug in the calendar year in which the
refund quarter occurs (or the 3-year or 2-year average as discussed
above in this section) will not be known until data is analyzed for the
report. To provide information in advance, CMS intends to communicate a
list of drugs that would have met conditions for having unique
circumstances of rarely utilized orphan drugs for CY 2022 no later than
December 31, 2023. This list would be provided as informational only
and may not necessarily reflect the same list of drugs that have unique
circumstances of rarely utilized orphan drugs when the data is analyzed
for the initial refund report. Each year, CMS will update the list of
drugs that have unique circumstances of rarely utilized orphan drugs
with those that met such conditions on the previous year's report. For
example, CMS will provide the list
[[Page 79057]]
of drugs with such unique circumstances for the initial report
(containing calendar quarters in 2023) no later than December 31, 2024.
Finally, in the proposed rule, we stated that we will identify
drugs that have unique circumstances of low volume doses and rarely
utilized orphan drugs in the report sent to manufacturers and apply the
increased applicable percentages based on these unique circumstances.
If a manufacturer believes that the incorrect applicable percentage was
applied to the refund calculation, the manufacturer may submit a
dispute regarding the calculation by submitting an error report (see
Sec. 414.940(e)).
After consideration of public comments, we are finalizing revisions
to Sec. 414.902 to add the definition ``low volume dose'' and Sec.
414.940(d) to add the increased applicable percentage of 90 percent for
drugs with a low volume dose contained within 0.1 mL or less and 45
percent for a drug with a low volume dose contained within 0.11 mL up
to 0.4 mL, as proposed. We also are finalizing as proposed at Sec.
414.940(d) the increased applicable percentage of 26 percent for a drug
designated an orphan drug under section 526 of the FD&C Act for a rare
disease or condition (or diseases or conditions), approved by the FDA
only for one or more indications within such designated rare disease or
condition (or diseases or conditions) and furnished to fewer than 100
unique beneficiaries per calendar year. We are adding that an average
of fewer than 100 beneficiaries per calendar year for the most recent 3
years (or 2 years, in certain circumstances) as discussed above in this
section would be considered to have such unique circumstances.
(4) Application Process for Increased Applicable Percentages
In the CY 2024 PFS proposed rule (88 FR 52393 through 52395), we
discussed our proposal to establish an application process through
which manufacturers may request that we consider an individual drug to
have unique circumstances for which an increased applicable percentage
is appropriate. We explained that manufacturers could benefit from a
formal process through which they can provide information, including
that which may not be publicly available, and therefore, not known to
us, in order to request an increase in their refundable drug's
applicable percentage and provide justification for why the drug has
unique circumstances for which such an increase is appropriate,
including in the case of a drug with an applicable percentage that has
already been increased by virtue of its unique circumstances.
We proposed that, to request CMS consider increasing the applicable
percentage of a particular refundable drug, a manufacturer must submit
the following: (1) a written request that a drug be considered for an
increased applicable percentage based on its unique circumstances; (2)
FDA-approved labeling for the drug; (3) justification for the
consideration of an increased applicable percentage based on such
unique circumstances; and (4) justification for the requested increase
in the applicable percentage. Such justification could include
documents, such as (but not limited to) a minimum vial fill volume
study or a dose preparation study. We proposed that in evaluating
requests for increased applicable percentages, we would review the
documentation referenced above for evidence that amounts of drug
identified in the FDA-approved package or labeling has similar loss of
product as that described in paragraph section 1847A(8)(B)(ii) of the
Act.
We stated that section 1847(h)(3)(B)(ii) of the Act requires that
any increase to applicable percentages for refundable drugs is to be
made through notice-and-comment rulemaking. Therefore, we proposed that
applications for individual applicable percentage increases be
submitted in a form and manner specified by CMS by February 1 of the
calendar year prior to the year the increased applicable percentage
would apply (for example, applications for increased applicable
percentages effective January 1, 2025, will be due to CMS by February
1, 2024). We proposed to discuss our analyses of applications in the
PFS rulemaking immediately following the application period, and to
communicate in the rule whether we consider the drug to have unique
circumstances that warrant an increased applicable percentage. We would
include proposals, if any, for increased applicable percentages, along
with a summary of any applications for which we determined not to
propose an increase in the applicable percentage. We proposed to codify
this application process for increased applicable percentages in new
paragraph Sec. 414.940(e).
We stated that we do not consider the following to be unique
circumstances warranting an increased applicable percentage at this
time: weight-based doses, body surface area (BSA)-based doses, varying
surface area of a wound, loading doses, escalation or titration doses,
tapering doses, and dose adjustments for toxicity because we believe
manufacturers can optimize the availability of products for these
circumstances to limit the percentage of discarded units for a drug,
unlike the circumstances of manufacturers of drugs that require
filtration during the preparation process, as described in section
1847A(h)(8)(B)(ii) of the Act. FDA draft guidance, titled ``Optimizing
the Dosage of Human Prescriptions Drugs and Biological Products for the
Treatment of Oncologic Diseases'',\155\ states: ``Various dose
strengths should be available to allow multiple dosages to be evaluated
in clinical trials. Perceived difficulty in manufacturing multiple dose
strengths is an insufficient rationale for not comparing multiple
dosages in clinical trials.'' Although optimization of dosage and
available product formulations most often occurs prior to marketing a
drug, we also observed several instances where the drug formulation
availability has been changed and subsequently resulted in a decreased
percentage of discarded amounts. For example, Kyprolis[supreg]
(carfilzomib), which is cross-walked to the billing and payment code
J9047, was available in only one 60-mg single-dose vial size when first
approved in 2012.\156\ Subsequently, a second 30-mg vial size was
approved in 2016,\157\ and a third 10-mg vial size was approved in June
of 2018.\158\ We observed in discarded drug data, based on the JW
modifier, that the percentage of discarded units for J9047 was 14.27,
12.68, 5.95, 4, and 3.09 percent in 2017, 2018, 2019, 2020, and 2021,
respectively. There is a sharp drop in the percent of discarded units
after 2018, which correlates with the introduction of the 10-mg vial.
The labeled dose of Kyprolis[supreg] is based on the patient's BSA,
there is a dose escalation, there are two different dosage schedules
(once weekly and twice weekly) each with differing doses, there are
dosage modifications for toxicity that involve dose reductions, and
there is a dose reduction for patients with hepatic impairment. With
these dose variations taken into consideration, the available vial
sizes of the drug allow for the percentage of discarded units to remain
well below 10
[[Page 79058]]
percent after the introduction of the third vial size.
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\155\ https://www.fda.gov/regulatory-information/search-fda-guidance-documents/optimizing-dosage-human-prescription-drugs-and-biological-products-treatment-oncologic-diseases.
\156\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202714lbl.pdf.
\157\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202714s012lbl.pdf.
\158\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202714s019lbl.pdf.
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In addition, we observed that, based on the 2021 discarded drug
data,\159\ as the number of available package sizes increases, the
percent discarded decreases (see Table 22). This example is indicative
of ways in which manufacturers can optimize package sizes to reduce the
percentage of discarded units in the circumstances listed above.
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\159\ https://data.cms.gov/summary-statistics-on-use-and-payments/medicare-medicaid-spending-by-drug/medicare-part-b-discarded-drug-units.
[GRAPHIC] [TIFF OMITTED] TR16NO23.043
We solicited comments from interested parties on the application
process for increased applicable percentage. Specifically, we solicited
comment on what factors we should use in a framework for considering
these applications, what factors we should use to assess appropriate
increases to applicable percentages, and what types of additional or
alternative documentation may help us analyze justifications for
increased applicable percentages.
We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: Several commenters expressed approval of the proposed
application process for increased applicable percentage, with several
adding that the process, if finalized, would provide manufacturers
transparency and predictability. One commenter specifically expressed
support for the proposal to use minimum vial fill studies or dose
preparation studies in CMS' evaluation of whether an increased
applicable percentage is appropriate for a refundable drug because such
studies examine whether a product contains a greater amount than is
necessary to accurately and consistently deliver the labeled
therapeutic dose. One commenter expressed support for CMS' engagement
with manufacturers in the development of the application process.
Response: We thank the commenters for their support.
Comment: Several commenters requested CMS maintain flexibility in
our approach to reviewing applications for increased applicable
percentage and work closely with the medical community as new
therapeutics and packaging practices develop. One commenter added that
dialogue between CMS and interested parties is important because novel
treatments may be ill-suited to the policy design of the discarded drug
refund program. One commenter requested that CMS conduct outreach to
manufacturers to ensure they are aware of the application process. One
commenter requested additional flexibility in the application process
by allowing manufacturers to request unique circumstance consideration
more frequently than once a year and outside the annual rulemaking
process.
Response: We thank the commenters for their feedback. We agree that
working with the medical community and other interested parties is
important to the implementation of the discarded drug refund program.
As the discarded drug refund policy develops, we will continue to rely
on feedback from the provider and manufacturer communities. Public
input gathered in the CY 2023 PFS rulemaking process, the Discarded
Drug Refund Policy Town Hall we hosted on February 1, 2023, and
meetings with interested parties provided the basis of the two proposed
unique circumstances and the framework for the application process for
increased applicable percentages. We plan to issue additional guidance
and communications to providers and suppliers prior to the application
window for increased applicable percentages taking effect in CY 2025.
Comment: One commenter expressed concern that the February 1
deadline for supporting documentation would create a significant lag
for consideration and approval of an increased applicable percentage if
a drug is approved on or after the deadline. The commenter requested
that companies whose drugs are nearing approval prior to the deadline
be allowed a fixed supplemental period to submit the FDA-approved label
after the deadline. The commenter cited precedent for this with new
technology add-on payments (NTAP) applications and the prior annual
Healthcare Common Procedure Coding System (HCPCS) coding process before
it was transitioned to a quarterly process.
Response: We appreciate the commenter's feedback. We are persuaded
by the commenter's suggestion that manufacturers whose products have
not yet been approved by the FDA should have additional flexibility in
completing their application submissions in anticipation of approval
prior to the calendar year following the application deadline. To
strike a balance between providing maximum flexibility to manufacturers
seeking consideration for increased applicable percentages and the
necessity that manufacturers possess sufficient information about the
dosing and packaging of their product to explain and provide evidence
for an unavoidable loss of product that meets the criterion for an
increased applicable percentage, we will allow manufacturers to submit
applications for increased applicable percentage prior to FDA approval
if the product's application for FDA approval has been accepted by the
FDA for review and such documentation of FDA acceptance can be provided
to CMS at the time of application for increased applicable percentage
prior to the application deadline. Similar to the NTAP
[[Page 79059]]
submission requirements for technologies that are not already FDA-
market authorized during the NTAP application period, we will require
manufacturers of drugs that are not FDA-approved to provide
documentation to demonstrate that an application has been accepted for
review by the FDA (for example, a filing letter) at the time of
submission of its application for an increased applicable percentage to
CMS. We believe it is important that applicants applying for an
increased applicable percentage have an accepted application for FDA
review of the product because it increases the likelihood they have
sufficiently studied issues related to vial size optimization and
minimization of unavoidable drug loss and reduces the risk of using
resources to review applications for drugs that will not be sold in the
calendar year for which we are considering applicable percentage
increases. Additionally, we believe documentation of FDA acceptance of
review, such as a filing letter, will provide the clearest and most
effective means of documenting that the applicant has submitted a
complete request to FDA and therefore we intend to require one such
document by February 1 for drugs that are not yet approved. Under the
final policy, drugs that do not yet have FDA approval at the time of
application for an increased applicable percentage will have three
deadlines for their application:
February 1 for all required documentation other than the
FDA-approved label, including documentation of FDA acceptance of the
product's application for review;
August 1 for FDA approval; and
September 1 for applicants to notify CMS of the product's
FDA approval and submit the approved label.
Therefore, we are modifying our proposed policy and finalizing a
policy that applicants must submit the following by February 1 of the
calendar year prior to the year the increased applicable percentage
would apply: (1) a written request that a drug be considered for an
increased applicable percentage based on its unique circumstances; (2)
FDA-approved labeling for the drug, or, if the drug is not yet
approved, documentation of the FDA acceptance of the application for
review; (3) justification for the consideration of an increased
applicable percentage based on such unique circumstances; and (4)
justification for the requested increase in the applicable percentage.
We are also finalizing that a manufacturer that does not have FDA
approval for its product by February 1 must receive FDA approval by
August 1 and submit the FDA-approved label to CMS by September 1 for
its application to be complete and eligible for consideration for an
increased applicable percentage based on unique circumstances. This
additional 6-month window for FDA marketing authorization is similar to
the extended deadline CMS currently allows applicants for NTAP that
have not received FDA marketing authorization prior to the NTAP
application deadline, generally in mid-October, of the year prior to
the beginning of the fiscal year for which the application is being
considered. Additionally, a drug that is approved on August 1 or later
will not have 18 months or more of claims paid under Part B before the
beginning of the calendar year 2 years following the application
period, and therefore, manufacturers will have an opportunity to apply
for increased applicable percentage and for that increased applicable
percentage to be effective prior the end of the 18-month exclusion from
the definition of refundable drug (as described in section
1847A(h)(8)(B)(iii) of the Act).
We note that for applicants that do not yet have FDA approval, once
the FDA approves a label for the product, certain aspects regarding,
for example, vial fill, labeled therapeutic dose, or estimated
discarded amounts may change after the time the application for
increased applicable percentage was submitted and when the product is
FDA-approved. As stated above, we are requiring that applicants notify
CMS by September 1 when the product is FDA-approved. At that time, CMS
will evaluate the FDA-approved label and compare it with the
application for determination of the increased applicable percentage.
In the case the approved label is no longer in accord with the
submitted justifications, we will consider the submitted justifications
as invalid and the application as both incomplete and ineligible for
consideration for a proposed increased applicable percentage. The
manufacturer will have an opportunity to apply for an increased
applicable percentage for the following year's application cycle.
Comment: Several commenters disagreed with the proposed exclusion
of weight-based doses, BSA-based doses, varying surface area of a
wound, loading doses, escalation or titration doses, tapering doses,
and dose adjustments for toxicity as bases for a unique circumstance.
Commenters described the challenges involved in achieving consistency
of vial sizes for individual patients, such as step-in doses that will
vary for a patient as they adjust to treatment, and the identification
of optimal vial sizes for these types of drugs. One commenter requested
an applicable percentage increase of 10 percent for drugs that are
indicated as loading doses as vial sizes are typically selected for
subsequent maintenance doses. Commenters added that the introduction of
additional vial sizes to limit discarded amounts may be impractical due
to great variance in patient needs, and for some manufacturers,
economically infeasible. In addition, one commenter stated that example
of Kyprolis vial sizes in the proposed rule confirms how long it can
take manufacturers to mitigate discarded drug refund liability, as its
two additional vial sizes were approved 4 and 6 years after the
product's initial approval.
Response: We thank the commenters for their comments on the
difficulties of reconciling highly varied patient characteristics into
a limited set of vial or container sizes, as well as those for drugs
with loading doses. While we acknowledge these challenges posed by
these circumstances, we do not consider them to be similar to products
that require filtration during preparation as described in section
1847A(8)(B)(ii) of the Act because the drug loss in the former cases is
not unavoidable. In each case, we believe manufacturers can, with vial
size optimization studies, identify a set of container sizes for which
less than ten percent of the labeled amount is usable and not necessary
for the reliable and safe delivery of the labeled therapeutic dose for
all patients, on average. Regarding the economic feasibility of
introducing a new vial size or multiple new sizes, we do not have
sufficient information about individual manufacturers' circumstances to
address whether introducing new vial sizes or optimizing vial sizes
would be economically feasible in each circumstance.
As shown in Table 22 and generally during our analysis of drugs
from single-dose containers, a vast majority of single-dose drugs are
manufactured in package sizes that are efficient enough to keep the
percentage of discarded amounts to less than 10 percent. In the case of
Kyprolis, we are not aware of the specific circumstances under which
the manufacturer chose to increase the number of vial sizes. Without
additional information about the specific circumstances, we cannot
speculate on particular business decisions of the manufacturer, when
the development of each vial size began, or how long it took for a new
vial size to be approved and marketed.
[[Page 79060]]
Comment: One commenter requested that CMS clarify how long
increased applicable percentages apply when increased through the
individual drug application process and subsequent rulemaking. The
commenter noted that a drug's unique circumstance on which an
applicable percentage increase is based is unlikely to change year to
year, and therefore requiring annual applications for the same drug
should not be required.
Response: We thank the commenter for their request for
clarification of the duration of the unique circumstances and increased
applicable percentages. We clarify that an increased applicable
percentage, once finalized through rulemaking, continues to apply until
modified through subsequent rulemaking. We note that drugs meeting the
criteria for unique circumstances of low volume doses or rarely
utilized orphan drugs could fluctuate, and we discuss communications of
which drugs meet such criteria above in this section.
Comment: Two commenters requested clarification regarding what
kinds of justifications, including supporting evidence, CMS will
consider bases of unique circumstances for which increased applicable
percentages are appropriate. The commenter also requested examples of
each.
Response: We thank the commenter for their request for
clarification of appropriate bases for unique circumstances and
increased applicable percentages. While we cannot anticipate future
drug development or what unique circumstances might arise, we can offer
our analysis of the unique circumstances we consider involving similar
loss of product as that described in section 1847A(h)(8)(B)(ii) of the
Act for drugs that are reconstituted in hydrogel and with variable
dosing based on patient-specific characteristics (87 FR 69727 through
69731), drugs with low volume doses, and rarely utilized orphan drugs
(both discussed in section III.A.3.d.(3) of this final rule). Regarding
examples of evidence, we noted minimum vial fill studies and dose
preparation studies in the proposed rule, both of which are suitable
for justifying increased applicable percentages because they can
establish that certain unusable amounts of a product are necessarily
included in a container to safely and consistently administered the
labeled therapeutic dose to a patient.
After consideration of public comments, we are finalizing our
proposal regarding the application process for increased applicable
percentages, including the application deadline of February 1 and, in
addition, we are finalizing a modification of our proposal by adopting
a deadline for the FDA-approved labeling of August 1 and the deadline
for notifying and submitting the FDA-approved label to CMS of September
1 of the year before the year in which the increased applicable
percentages would apply, in new Sec. 414.940(e).
e. Clarification for the Definition of Refundable Drug
As discussed in the CY 2023 PFS final rule (87 FR 69650 through
69655), we aim to create a consistent coding and payment approach for
the suite of products currently referred to as skin substitutes. In the
CY 2024 PFS proposed rule (88 FR 52395), we noted CMS anticipates
addressing coding and payment for skin substitutes in future
rulemaking. We explained that while we considered making changes to the
Medicare Part B payment policies for such products, we proposed that
billing and payment codes that describe products currently referred to
as skin substitutes are not counted for purposes of identifying
refundable drugs for calendar quarters during 2023 and 2024.
We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: Several commenters agreed with the proposal to not
consider skin substitutes as refundable drugs for 2023 and 2024. One
commenter added that the exclusion is appropriate because payment for
skin substitutes is inconsistent across settings and because claims
edits for appropriate JW and JZ modifier use were not in place for the
first three quarters of calendar year 2023 to ensure accurate
accounting of discarded amounts. Two commenters that agreed with the
proposal disagreed with CMS' assertion that CMS had discretion to count
these products in the first place, as they fall outside the statutory
definition of a refundable drug in section 1847A(h)(8)(A) of the Act,
which applies to products that are either a single-source drug or
biological (as defined in subsection (c)(6)(D)) or a biosimilar
biological product (as defined in subsection (c)(6)(H)), neither of
which describe skin substitutes. The commenters requested that CMS
acknowledge that skin substitutes are statutorily precluded from the
policy.
Response: We thank commenters for their feedback as we continue to
consider refinements to skin substitute policies. The comment
solicitation in the CY 2024 PFS proposed rule will inform future policy
development for the payment of skin substitutes.
Regarding the lack of enforcement of JW and JZ modifier use through
the first three quarters of 2023, section 1847A of the Act only speaks
to the use of JW data for the calculation of reporting discarded
amounts and assessing refund obligations. In the CY 2023 PFS final rule
(87 FR 69712 through 69728) we established the JZ modifier and
finalized plans to edit for JW and JZ modifier use, which are described
more fully in program instruction,\160\ to improve the quality of
discarded amount data. Although we proposed in the CY 2023 PFS proposed
rule to require the JZ modifier beginning January 1, 2023, we delayed
the requirement in the final rule to October 1, 2023, in response to
comments to allow a transition period for providers, billing software
vendors, and MACs to adjust billing and claims review processes (87 FR
69717). For these reasons, we disagree that this delay prevents us from
using JW modifier data to calculate discarded drug refunds for the
first three quarters of 2023.
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\160\ https://www.cms.gov/files/document/r12067cp.pdf.
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Comment: One commenter requested that we clarify how CMS will
handle claims for skin substitutes reported with the JW modifier in a
future payment methodology.
Response: In the CY 2024 PFS proposed rule (88 FR 52357 through
52358), we solicited comment on potential approaches to billing but did
not propose any revisions to the payment approach for skin substitutes
under Part B for CY 2024. Therefore, we cannot comment on how claims
for skin substitutes that report JW data, or the reported JW data, will
be processed under a future payment approach.
Further discussion of a potential future billing approach for skin
substitute products is in section II.H of this final rule. For this
final rule, for CY 2023 and 2024, we are finalizing that JW units of
skin substitutes will not be used for the discarded drug refund
calculations and we will not issue reports to manufacturers with
respect to skin substitutes.
Comment: One commenter requested that CMS explicitly confirm the
statutory exclusion for imaging agents in section 1847A(h)(8)(B)(i) of
the Act includes contrast agents.
Response: We point the commenter to the discussion in CY 2023 PFS
final rule (87 FR 69724). In response to two commenters requesting the
same confirmation, we stated that we recognize contrast agents as a
category of imaging agents as described in FDA's Guidance for Industry.
Therefore, we
[[Page 79061]]
clarified that contrast agents are excluded from the definition of
refundable single-dose container or single-use package drug.
Comment: Two commenters requested that we treat drugs or
biologicals that are regarded as multiple source drugs under section
1847A(c)(6)(C)(ii) of the Act as multiple source drugs for purposes of
the discarded drug refund.
Response: The definition of refundable drug under section
1847A(h)(8)(A) of the Act requires that such drugs are single source
drugs or biologicals (as defined in subsection (c)(6)(D)) or a
biosimilar biological product (as defined in subsection (c)(6)(H)). The
definition of single source drug or biological requires that the drug
is not a multiple source drug, which is defined at section
1847A(c)(6)(C) of the Act. Therefore, we agree with the commenter and
clarify that, under section 1847A(c)(6)(C)(ii) of the Act, single
source drugs or biologicals that were within the same billing and
payment code as of October 1, 2003, will be treated as multiple source
drugs for the purposes of the discarded drug refund.
f. Clarification for the Determination of Discarded Amounts and Refund
Amounts
Section 1847A(h) of the Act specifies that discarded amounts of
refundable drugs are to be determined using a mechanism such as the JW
modifier used as of the date of enactment of the Infrastructure Act or
any successor modifier that includes such data as determined
appropriate by the Secretary. In the CY 2023 PFS final rule (87 FR
69718 through 69719), we finalized our previously existing policy that
required billing providers report the JW modifier for all separately
payable drugs with discarded drug amounts from single use vials or
single use packages payable under Part B, beginning January 1, 2023.
In the CY 2024 PFS proposed rule (88 FR 52395), we discussed the
applicability of the JW modifier in Medicare Advantage claims. We
stated that since the JW modifier, the mechanism described in section
1847A(h) of the Act, is not required in Medicare Advantage claims for
drugs payable under Medicare Part B and there is not a similar
mechanism to identify discarded units of such drugs that are billed to
Medicare Advantage plans, we proposed to clarify that the JW modifier
requirement does not apply to units billed to Medicare Advantage plans
and that the refund amount calculations under section 1847A(h)(3) of
the Act will not include units billed to Medicare Advantage plans.
We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: Several commenters expressed support for our proposal to
exclude units for refundable drugs billed to Medicare Advantage plans
from the calculation of refund amounts.
Response: We thank the commenters for their support.
Comment: While agreeing that the JW modifier is not required for
units billed to Medicare Advantage plans, one commenter requested that
we clarify that the definition of a refundable drug as described in
section 1847A(h)(8) limits the scope of the provision to Part B fee-
for-service claims.
Response: We thank the commenter for their feedback. As finalized
in in the 2023 PFS final rule (87 FR 69710 through 69734), our policy
is to determine the total number of discarded units using the JW
modifier (or any successor modifier that includes the same data). This
policy results in the exclusion of units billed to Medicare Advantage
plans. We do not believe it is necessary to evaluate additional
arguments for excluding units billed to MA plans in this final rule.
Comment: One commenter requested clarification regarding whether
Medicare Advantage plans are permitted to require the reporting of the
JW modifier. The commenter cited Chapter 4, Section 10.2 of the
Medicare Managed Care Manual, which states that Medicare Advantage
plans have discretion to establish their own billing and payment
procedures, both for contracted and uncontracted providers, and such
discretion extends to the option to adopt fee-for-service billing
modifiers.
Response: We thank the commenter for their request for
clarification. We are clarifying that since the JW modifier, the
mechanism described in section 1847A(h)(1) of the Act, is not
necessarily required by all Medicare Advantage plans, we cannot ensure
that any JW modifier data gathered by Medicare Advantage plans is
consistently done so in accordance with our JW and JZ modifier use
policy, the refund amount calculations under section 1847A(h)(3) of the
Act will not include units billed to Medicare Advantage plans.
After reviewing all comments, we are finalizing the clarification
that we will not include units billed to Medicare Advantage plans in
calculations under section 1847A(h)(3) of the Act because we cannot
ensure data for refundable drugs billed to plans is consistently
collected in accordance with the same reporting requirements. We are
finalizing the additional clarification that Medicare Advantage plans
are not required, but are permitted, to adopt the Medicare fee-for-
service JW and JZ modifier requirements for single-dose container drugs
that are separately payable under Part B; however, those units will not
be included in the refund amount calculations.
g. Technical Changes
In the CY 2023 PFS final rule (87 FR 70227) we finalized the
regulation text for the calculation of the manufacturer refund
requirement. That text contained an error in two places, Sec.
[thinsp]414.940(c)(3) and (d), which incorrectly referenced paragraph
(c)(1)(ii) of that section in reference to the applicable percentage,
rather than paragraph (c)(2). In the CY 2024 PFS proposed rule (88 FR
52395), we proposed to correct the textual reference in both paragraphs
and make additional technical changes to streamline the text.
We did not receive any comments on these proposed technical
corrections and are finalizing as proposed.
h. Use of the JW Modifier and JZ Modifier Policy
In the CY 2023 PFS final rule (87 FR 69723), we discussed the
applicability of the JW and JZ modifier policy to drugs that are not
administered by the billing supplier, including drugs furnished through
a covered item of DME that may be administered by the beneficiary. In
such cases, suppliers who dispense drugs payable under Medicare Part B
do not actually administer the drug, as the claim is typically
submitted prior to the administration of the drug, and the billing
provider or supplier is not at the site of administration to measure
discarded amounts. We stated that since we do not believe it would be
appropriate to collect data about discarded amounts from beneficiaries,
the reporting requirement does not apply to drugs that are self-
administered by a patient or caregiver in the patient's home. In the
updated FAQ for the JW/JZ modifier policy \161\ released on January 5,
2023, we reiterated that suppliers who dispense but do not actually
administer a separately payable drug are not expected to report the JW
modifier.
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\161\ https://www.cms.gov/medicare/medicare-fee-for-service-payment/hospitaloutpatientpps/downloads/jw-modifier-faqs.pdf.
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In the CY 2024 PFS proposed rule (88 FR 52395) we discussed that
beginning
[[Page 79062]]
October 1, 2023, we will begin editing for correct use of both the JW
and JZ modifiers for billing and payment codes for drugs from single-
dose containers (87 FR 69719). However, because currently there is no
claims modifier to designate that a drug was dispensed, but not
administered, by the billing supplier, we were concerned that the
policy finalized last year exempting self-administered drugs from the
JW/JZ modifier policy may result in claims rejections absent a
modification. Therefore, we proposed to require that drugs separately
payable under Part B from single-dose containers that are furnished by
a supplier who is not administering the drug be billed with the JZ
modifier, since we continued to believe it is unreasonable to collect
discarded drug data from beneficiaries.
We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: Two commenters expressed support for the proposal to not
to apply the discarded drug refund to units of single-dose container
drugs that are furnished but not administered by the billing supplier.
The commenters echoed our position that it is not feasible for Medicare
beneficiaries to track and accurately report discarded amounts.
Response: We thank the commenters for their support.
Comment: Two commenters stated they oppose the requirement to
report the JZ modifier for drugs furnished but not administered by the
biller. One commenter recommended that instead of requiring the use of
the JZ modifier, CMS instead improve compliance with the JW modifier
policy by enhancing provider and supplier education efforts. Two
commenters suggested another alternative in which CMS develops a new
modifier to be reported on claims for these drugs to separate them from
the calculation of discarded drug refund amounts. One commenter added
that a new modifier would be more appropriate because the supplier
cannot in fact determine that there were no discarded amounts when the
patient self-administers the drug for which the supplier is submitting
a claim, as the reporting of the JZ modifier suggests; rather, the JZ
modifier's use in this instance in fact means that the discard drug
refund policy does not apply to these drugs.
Response: As we noted in the CY 2023 PFS final rule (87 FR 69716
through 69717), the Committee on Implications of Discarded Weight-Based
Drugs found compliance with the JW modifier requirement not only varied
among providers and suppliers, but even providers and suppliers who use
the modifier do not do so consistently and vary in their reporting from
one drug to another and across claims for the same patient and
drug.\162\ We do not believe that provider and supplier education alone
can obtain the consistent reporting of JW modifier data needed for the
implementation of this provision.
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\162\ National Academies of Sciences, Engineering, and Medicine.
2021. Medications in single-dose vials: Implications of discarded
drugs. Washington, DC: The National Academies Press. https://doi.org/10.17226/25911. National Academies of Sciences, Engineering,
and Medicine. 2021. Medications in Single-Dose Vials: Implications
of Discarded Drugs. Washington, DC: The National Academies Press.
https://doi.org/10.17226/25911.
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Regarding the establishment of a new modifier for drugs covered
under the DMEPOS benefit, we agree this approach would accomplish the
same objective in avoiding the rejection of claims for which we do not
expect to receive JW modifier data. We do not, however, see how the
requirement that suppliers of drugs covered under the DMEPOS benefit
report a new modifier rather than the JZ modifier would reduce
administrative burden on the supplier. One potential benefit to the
program would be, rather, that billing units of such drugs are not
automatically counted as administered with zero discarded amounts, but
we do not have any reason, at this time, to believe this would result
in additional refund obligations. We may revisit this suggestion in
future rulemaking.
Comment: One commenter requested that CMS take efforts to minimize
the discarded drug refund policy's compliance burden on providers and
suppliers. One commenter stated that because discarded amounts for
drugs covered under the DMEPOS benefit are consistently far below 10
percent, the JZ modifier requirement for these drugs does not provide a
program benefit that justifies the administrative burden it would place
on suppliers.
One commenter described the issuance of contradictory guidance by
DME MACs that has created confusion about whether providers and
suppliers are required to report the JZ modifier for single-dose
container drugs that are dispensed but not administered to patients
beginning July 1, 2023 or October 1, 2023, or not at all. The commenter
requested that CMS direct DME MACs to update their external fusion pump
local coverage articles to clarify the JW and JZ modifier policy for
single-dose drugs that are dispensed, but not administered to patients
for dates of service between July 1 and October 1, 2023 and for dates
of service after October 1, 2023, regardless of whether the local
coverage article is updated in time to reflect the new billing
requirement.
Response: As we stated in the CY 2023 PFS final rule discussion on
provider burden (87 FR 69716), we believe that in most cases the JW and
JZ modifier requirements impose no new burdens on providers beyond the
requirement of measuring and reporting discarded amounts by use of the
JW modifier that predates the enactment of the discarded drug refund
policy under section 1847A(h) of the Act. Providers and suppliers who
have been complying with the JW modifier requirement effective January
1, 2017 have already been assessing and documenting what is needed for
the JZ modifier, and the new requirement of reporting the JZ modifier
is minimal and justifiable for the purposes of obtaining more complete
discarded amount data.
Regarding the confusion about the billing requirements for
suppliers who dispense, but do not administer a single-dose drug to
patients, since we did not finalize the requirement to report the JZ
modifier in this situation in the CY 2023 PFS final rule, we cannot
require it to be reported for dates of service in CY 2023. On October
16, 2023, we updated the JW and JZ Modifier FAQ \163\ to provide
additional clarity and resolve concerns about processing claims for
single-dose drugs that are self-administered by a patient or caregiver
in the patient's home before CY 2024 billing requirement updates take
effect. The updated FAQ provides reference to a published list of
specific billing and payment codes to which only single-dose containers
are assigned, and thus, may require use of the JW or JZ modifiers
depending on the setting of use. The identified codes should not be
considered an all-inclusive list of codes that are subject to the JW
and JZ modifier policy. The list is available on the ASP Billing
Resources website.\164\
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\163\ https://www.cms.gov/medicare/medicare-fee-for-service-payment/hospitaloutpatientpps/downloads/jw-modifier-faqs.pdf.
\164\ https://www.cms.gov/medicare/payment/all-fee-service-providers/medicare-part-b-drug-average-sales-price/asp-billing-resources.
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Comment: One commenter stated that CMS has long stated that it
expects providers and suppliers to use drugs in a clinically
appropriate manner and has consistently advised that all procedures for
drug reconstitution and administration should conform to applicable FDA
guidelines, one of which states that any extra amount of the drug
remaining after the dose is administered must be discarded.
[[Page 79063]]
Another commenter requested clarification of correct JZ modifier use
when drugs from a single-dose containers are used for multiple
patients.
Response: The JW Modifier and JZ Modifier Policy Frequently Asked
Questions document \165\ reiterates language in Chapter 17 of the
Medicare Claims Processing Manual,\166\ which states that CMS
encourages physicians, hospitals and other providers and suppliers to
care for and administer drugs and biologicals to patients in such a way
that they can use drugs or biologicals most efficiently, in a
clinically appropriate manner. In the resources section of the FAQ
document, there is a link to a memorandum from the Survey and
Certification Group at CMS regarding entitled Safe Use of Single Dose/
Single Use Medications to Prevent Healthcare-associated
Infections.\167\ In this memorandum CMS clarified guidance regarding
the various infection control regulatory requirements to indicate that
when previously unopened single-dose vials are repackaged consistent
with aseptic conditions under the requirements of USP <797>, and
subsequently stored consistent with USP <797> and the manufacturer's
package insert, it is permissible for healthcare personnel to
administer repackaged doses derived from single-dose vials to multiple
patients, provided that each repackaged dose is used for a single
patient in accordance with applicable storage and handling
requirements. We reiterate the JZ modifier policy that the modifier is
used to attest that no amount of drug was discarded from single-dose
container drugs. To align with the JW modifier policy, the JZ modifier
is required when there are no discarded amounts of a single-dose
container drug for which the JW modifier would be required if there
were discarded amounts. In addition, we clarify that JZ modifier policy
does not require that the claim line with the JZ modifier account for
only whole vials of the drug and the JW modifier policy does not
require that the two claim lines (as described in the modifier FAQ
document \168\) account for only whole vials of the drug.
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\165\ https://www.cms.gov/medicare/medicare-fee-for-service-payment/hospitaloutpatientpps/downloads/jw-modifier-faqs.pdf.
\166\ https://www.cms.gov/regulations-and-guidance/guidance/
manuals/downloads/clm104c17.pdf.
\167\ https://www.cms.gov/medicare/provider-enrollment-and-certification/surveycertificationgeninfo/downloads/survey-and-cert-letter-12-35.pdf.
\168\ https://www.cms.gov/medicare/medicare-fee-for-service-payment/hospitaloutpatientpps/downloads/jw-modifier-faqs.pdf.
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Comment: One commenter requested clarification regarding the JW/JZ
reporting requirements for drugs that are excluded from the definition
of ``refundable drug'' and are therefore exempt from refunds for
discarded amounts. The commenter requested that such drugs that do not
meet the definition of a refundable drug be billed with the JZ
modifier, similar to those that are furnished but not administered by a
supplier.
Response: As stated in the CY 2023 PFS final rule (87 FR 69724),
even if a drug is excluded from the definition of refundable single-
dose container or single-use package drug (and not subject to refunds),
for example, multiple source drugs, claims for such drugs furnished
from a single-dose container are still required to use the JW and JZ
modifiers in accordance with the policy.
After reviewing all comments, we are finalizing as proposed the
requirement that drugs separately payable under Part B from single-dose
containers that are furnished by a supplier who is not administering
the drug be billed with the JZ modifier.
i. General Comments
We received several public comments on these proposals, generally.
The following is a summary of the comments we received and our
responses.
Comment: One commenter expressed support for CMS' ongoing efforts
to implement section 90004 of the Infrastructure Act by continuing to
refine the process for manufacturers to provide a refund to CMS for
certain discarded amounts from refundable drugs. The commenter stated
that implementation of the discarded drug refund will help reduce waste
and spending within the Medicare program by discouraging drug
manufacturers from overfilling single-dose containers.
Response: We thank the commenter for their support.
Comment: One commenter states that the discarded drug refund exacts
financial penalties due to a drug's FDA-approved labeling and efficacy
and safety profile, and administration of the product by healthcare
providers, over which a manufacturer exerts no control.
Response: Section 1847A(h)(3) of the Act requires that the refund
calculation use the total number of units of the billing and payment
code of such drug, if any, that were discarded for a given calendar
quarter for which a refund is due, as determined using a mechanism such
as the JW modifier. CMS is implementing the law.
Comment: One commenter noted that for biosimilar biological
products (hereafter, biosimilars), introducing new vial sizes would not
be feasible, because manufacturers of biosimilars must offer the same
vial sizes as the reference product.
Response: To date, we have not observed any biosimilars that have
discarded amounts exceeding 10 percent. However, we will continue to
monitor discarded drug data for biosimilars. We also note that section
90004 of the Infrastructure Investment and Jobs Act requires the Office
of Inspector General (OIG), after consultation with CMS and FDA, to
submit a report to Congress on any reported impact that section 90004
may have on the licensure, market entry, market retention, or marketing
of biosimilars. The OIG is expected to issue a report to Congress in
fiscal year (FY) 2024.\169\
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\169\ https://oig.hhs.gov/reports-and-publications/workplan/summary/wp-summary-0000743.asp.
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Comment: One commenter expressed concern that the discarded drug
refunds will impact provider reimbursement.
Response: Since Medicare pays for units of single-dose drugs that
are administered to the patient as well as units that are discarded
(and billed using the JW modifier), we do not expect the refund to
affect reimbursement to providers.
j. Out of Scope Comments
Comment: We received comments on several topics that were outside
the scope of the proposed rule. Those topics included the following:
the contents of the preliminary report (87 FR 69725) and the annual
refund report described in Sec. 414.940(a)(1) and manufacturers'
ability to use them to identify potential calculation errors; a request
that the window for submitting an error report be extended to 60 days;
several requests for the establishment of an appeals process including
for calculated refund amounts and for unique circumstance applications;
support for our reaffirmation of the exclusion of radiopharmaceuticals
and imaging agents from the definition of refundable drugs; requests
that all non-refundable drugs or just radiopharmaceuticals and imaging
agents be excluded from the JW and JZ modifier reporting policy; a
request that we clarify that all non-refundable drugs single-dose
container drugs be reported with the JZ modifier; a request for
clarification on correct JZ modifier use when drugs from a single dose
vial are used for multiple patients; a request that CMS develop a
mechanism to automate the reporting of discard amounts in claims
systems; a request that Medicare compensate provider and suppliers for
the discarded
[[Page 79064]]
amount reporting burden; support for the JW and JZ modifier edits;
offers to collaborate with CMS on provider education for the JW and JZ
modifier requirements; a statement of concern about complications for
reporting JW and JZ modifier data in systems in which EHR recording for
single-dose container drugs is automated; a request for a delay in the
beginning of edits for correct JW and JZ modifier use; a request for
additional provider education on the discarded drug refund policy; a
request for a requirement that all skin substitute products report ASP
data; a request that CMS affirm the 18-month exclusionary period for
Leqembi begins on October 1, 2023; a request for drugs whose use is
required by an unrelated manufacturer over which the product's
manufacturer has no control and the establishment of new HCPCS codes
for products based on alternative utilization methods to be considered
to have unique circumstances; a request for newly approved drugs when
the manufacturer is actively carrying out post-market optimization
activities to be considered to have unique circumstances; two requests
that we confirm that certain drugs meet the definition of the rarely
utilized orphan drugs for which we proposed a unique circumstances; a
request from several commenters that we extend through rulemaking the
18-month exclusion period for newly marketed drugs, as described in
section 1847A(h)(8)(B)(iii) of the Act, to 36 months; a request from
several commenters for cell and gene therapies and other personalized
therapies to be considered to have a unique circumstance and have an
increased applicable percentage, as well as a request that in
considering future HCPCS applications for these therapies we consider
the implications of any decision on its potential discarded drug refund
obligations; and a request for drugs that treat multiple indications
across unique patient types and characteristics to be considered to
have unique circumstances.
Response: While these comments are out of scope for this final rule
because they do not relate to the specific proposals included in the
proposed rule, we appreciate the feedback and may consider these
recommendations for future rulemaking.
B. Rural Health Clinics (RHCs) and Federally Qualified Health Centers
(FQHCs)
1. Background
a. RHC and FQHC Payment Methodologies
As provided in 42 CFR part 405, subpart X of our regulations, RHC
and FQHC visits generally are defined as face-to-face encounters
between a patient and one or more RHC or FQHC practitioners during
which one or more RHC or FQHC qualifying services are furnished. RHC
and FQHC practitioners are physicians, NPs, PAs, CNMs, clinical
psychologists (CPs), and clinical social workers, and under certain
conditions, a registered nurse or licensed practical nurse furnishing
care to a homebound RHC or FQHC patient in an area verified as having
shortage of home health agencies. We note, as discussed in section
III.B.2.b. of this final rule, effective January 1, 2024 RHC and FQHC
practitioners can also be licensed marriage and family therapists or
mental health counselors. Transitional Care Management (TCM) services
can also be paid by Medicare as an RHC or FQHC visit. In addition,
Diabetes Self-Management Training (DSMT) or Medical Nutrition Therapy
(MNT) sessions furnished by a certified DSMT or MNT program may also be
considered FQHC visits for Medicare payment purposes. Only medically
necessary medical, mental health, or qualified preventive health
services that require the skill level of an RHC or FQHC practitioner
are RHC or FQHC billable visits. Services furnished by auxiliary
personnel (for example, nurses, medical assistants, or other clinical
personnel acting under the supervision of the RHC or FQHC practitioner)
are considered incident to the visit and are included in the per-visit
payment.
RHCs generally are paid an all-inclusive rate (AIR) for all
medically necessary medical and mental health services and qualified
preventive health services furnished on the same day (with some
exceptions). The AIR is subject to a payment limit, meaning that an RHC
will not receive any payment beyond the specified limit amount. As of
April 1, 2021, all RHCs are subject to new payment limits on the AIR,
and this limit will be determined for each RHC in accordance with
section 1833(f) of the Act.
FQHCs were paid under the same AIR methodology until October 1,
2014. Beginning on that date, in accordance with section 1834(o) of the
Act (as added by section 10501(i)(3) of the Patient Protection and
Affordable Care Act (Pub. L. 111-148), FQHCs began to transition to the
FQHC PPS system, in which they are paid based on the lesser of the FQHC
PPS rate or their actual charges. The FQHC PPS rate is adjusted for
geographic differences in the cost of services by the FQHC PPS
geographic adjustment factor (GAF). The rate is increased by 34 percent
when an FQHC furnishes care to a patient that is new to the FQHC, or to
a beneficiary receiving an initial preventive physical examination
(IPPE) or has an annual wellness visit (AWV).
Both the RHC AIR and FQHC PPS payment rates were designed to
reflect the cost of all services and supplies that an RHC or FQHC
furnishes to a patient in a single day. The rates are not adjusted at
the individual level for the complexity of individual patient health
care needs, the length of an individual visit, or the number or type of
practitioners involved in the patient's care. Instead for RHCs, all
costs for the facility over the course of the year are aggregated and
an AIR is derived from these aggregate expenditures. The FQHC PPS base
rate is updated annually by the percentage increase in the FQHC market
basket reduced by a productivity adjustment.
2. Implementation of the Consolidated Appropriations Act (CAA), 2023
a. Section 4113 of the Consolidated Appropriations Act, 2023
In the CY 2022 PFS final rule with comment (86 FR 65211), we
revised the regulatory requirement that an RHC or FQHC mental health
visit must be a face-to-face (that is, in person) encounter between an
RHC or FQHC patient and an RHC or FQHC practitioner. We revised the
regulations under Sec. 405.2463 to state that an RHC or FQHC mental
health visit can also include encounters furnished through interactive,
real-time, audio/video telecommunications technology or audio-only
interactions in cases where beneficiaries are not capable of, or do not
consent to, the use of devices that permit a two-way, audio/video
interaction for the purposes of diagnosis, evaluation or treatment of a
mental health disorder. We noted that these changes aligned with
similar mental health services furnished under the PFS. We also noted
that this change allows RHCs and FQHCs to report and be paid for mental
health visits furnished via real-time, telecommunication technology in
the same way they currently do when these services are furnished in-
person. In addition, we revised the regulation
[[Page 79065]]
under Sec. 405.2463 to state that there must be an in-person mental
health service furnished within 6 months prior to the furnishing of the
telecommunications service and that an in-person mental health service
(without the use of telecommunications technology) must be provided at
least every 12 months while the beneficiary is receiving services
furnished via telecommunications technology for diagnosis, evaluation,
or treatment of mental health disorders, unless, for a particular 12-
month period, the physician or practitioner and patient agree that the
risks and burdens outweigh the benefits associated with furnishing the
in-person item or service, and the practitioner documents the reasons
for this decision in the patient's medical record (86 FR 65210 and
65211).
We also revised the regulation under Sec. 405.2469, FQHC
supplemental payments, to state that a supplemental payment required
under this section is made to the FQHC when a covered face-to-face
(that is, in-person) encounter or an encounter where services are
furnished using interactive, real-time, telecommunications technology
or audio-only interactions in cases where beneficiaries do not wish to
use or do not have access to devices that permit a two-way, audio/video
interaction for the purposes of diagnosis, evaluation or treatment of a
mental health disorder occurs between a MA enrollee and a practitioner
as set forth in Sec. 405.2463. At Sec. 405.2469, we also revised
paragraph (d) to describe the same in-person visit requirement
referenced in Sec. 405.2463.
As discussed in the CY 2023 PFS final rule (87 FR 69738), the
Consolidated Appropriations Act, 2022 (CAA, 2022) (Pub. L. 117-103,
March 15, 2022) included the extension of a number of Medicare
telehealth flexibilities established during the public health emergency
(PHE) for COVID-19 for a limited 151-day period beginning on the first
day after the end of the PHE for COVID-19. Specifically, Division P,
Title III, section 304 of the CAA, 2022, delayed the in-person
requirements under Medicare for mental health services furnished
through telehealth under the PFS and for mental health visits furnished
by RHCs and FQHCs via telecommunications technology until the 152nd day
after the end of the PHE for COVID-19. Therefore, in the CY 2023 PFS
final rule (87 FR 69737), we revised the regulations under Sec. Sec.
405.2463 and 405.2469 again to reflect these provisions.
As discussed in the CY 2024 PFS proposed rule (88 FR 52396 through
52397), the CAA, 2023 (Pub. L. 117-328, December 29, 2022) extends the
Medicare telehealth flexibilities enacted in the CAA, 2022 for a period
beginning on the first day after the end of the PHE for COVID-19 and
ending on December 31, 2024, if the PHE ends prior to that date.
Specifically related to RHCs and FQHCs, section 4113(c) of the CAA,
2023 amends section 1834(m)(8) of the Act to extend payment for
telehealth services furnished by FQHCs and RHCs for the period
beginning on the first day after the end of the COVID-19 PHE and ending
on December 31, 2024, if the PHE ends prior to that date. We noted that
payment continued to be made under the methodology established for
telehealth services furnished by FQHCs and RHCs during the PHE, which
is based on payment rates that are similar to the national average
payment rates for comparable telehealth services under the PFS. We also
noted that we did not believe it necessary to conform the regulation to
this temporary provision. Rather, we used our authority in section
4113(h) of the CAA, 2023 to issue program instructions or other
subregulatory guidance to effectuate this provision to ensure a smooth
transition after the PHE.\170\
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\170\ https://www.cms.gov/files/document/rural-health-clinics-and-federally-qualified-health-centers-cms-flexibilities-fight-covid-19.pdf.
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We explained that section 4113(d) of the CAA, 2023 continues to
delay the in-person requirements under Medicare for mental health
services furnished through telehealth under the PFS and for mental
health visits furnished by RHCs and FQHCs via telecommunications
technology. That is, for RHCs and FQHCs, in-person visits will not be
required until January 1, 2025 or, if later, the first day after the
end of the PHE for COVID-19. Therefore, we stated that we will continue
to apply the delay of the in-person requirements under Medicare for
mental health services furnished by RHCs and FQHCs. We noted, the
Department of Health and Human Services declared an end to the Federal
PHE for COVID-19 under section 319 of the Public Health Service Act on
May 11, 2023.\171\
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\171\ https://www.hhs.gov/coronavirus/covid-19-public-health-emergency/index.html.
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Accordingly, we proposed to make conforming regulatory text changes
based on CAA, 2023 to the applicable RHC and FQHC regulations in 42 CFR
part 405, subpart X, specifically, at Sec. 405.2463, ``What
constitutes a visit,'' we proposed to amend paragraph (b)(3) and, at
Sec. 405.2469 ``FQHC supplemental payments,'' we proposed to amend
paragraph (d) to include the delay of the in-person requirements for
mental health visits furnished by RHCs and FQHCs through
telecommunication technology under Medicare beginning January 1, 2025.
We noted that we are not revising the regulation text to reflect ``or,
if later, the first day after the end of the PHE for COVID-19'' as the
legislation states since the end of the PHE was May 11, 2023.
We noted that in the CY 2023 PFS final rule (87 FR 69738), we
listed the several other provisions of the CAA, 2022 that apply to
telehealth services (those that are not mental health visits) furnished
by RHCs and FQHCs. For details on the other Medicare telehealth
provisions in the CAA, 2022, see section II.D. of this final rule. We
also noted that the CAA, 2023 extended the telehealth policies
mentioned above and enacted in the CAA, 2022 through December 31, 2024.
We received many comments on the extension of telehealth
flexibilities under section 4113 of CAA, 2023. The following is a
summary of the public comments received and our responses:
Comment: Many commenters generally supported the extension of
telehealth flexibilities for RHCs and FQHCs and the delay of the in-
person requirements for mental health services, as required under
section 4113 of CAA, 2023.
Response: We thank commenters for their support.
Comment: We received several comments requesting that the COVID-19
telehealth flexibilities be made permanent. Although one commenter
acknowledged that CMS does not have the authority to make the changes
related to payment of FQHCs and RHCs for telehealth services beyond
December 31, 2024, several commenters requested that CMS work with
Congress to ensure the telehealth flexibilities remain in place
indefinitely. One commenter explained that this would include
telehealth flexibilities related to continuing payment for telehealth
services, removing the in-person visit requirements for mental health
visits, expanding the originating site requirements to include any site
in the U.S. the beneficiary is located (for example, the individual's
home) and extending coverage and payment of telehealth services that
are furnished via audio-only communications. Commenters explained that
they believe if FQHCs and RHCs are no longer able to furnish telehealth
services to patients after December 31, 2024, this will limit access to
care and may negatively impact patient health.
[[Page 79066]]
Response: We thank commenters for their input. The CAA, 2023 does
not extend these policies beyond December 31, 2024. We do not have the
authority to make these flexibilities permanent.
Comment: We received comments from the RHC and FQHC community
requesting CMS revise the definition of a medical visit so that these
services can be furnished via telecommunication technologies similar to
what CMS finalized in the CY 2022 PFS final rule (86 FR 65208 through
65211) for mental health visits furnished via telecommunication
technologies. A few commenters urged CMS to revise the ``medical
visit'' definition before January 1, 2025, stating that they believe
that this action would avoid significant gaps in care for some of the
most vulnerable Medicare patients. The commenter suggested that CMS
consider these consequences if Medicare patients cannot receive virtual
medical services due to a lapse in coverage and payment. The same
commenters stated that they believe CMS has the authority to revise
Sec. 405.2463(b)(1) to define a medical visit as a face-to-face
encounter or encounter where services are furnished using interactive,
real-time, audio and video telecommunications technology or audio-only
interactions in cases where beneficiaries are not capable of or do not
consent to, the use of devices that permit a two-way audio/video
interaction for the purposes of diagnosis, evaluation or treatment of
services under Sec. 405.2463(b)(2). Commenters further stated that if
CMS were to revise the definition of a ``medical visit'' so that these
services can be furnished via telecommunication technologies, CMS
should also amend cost reporting instructions to ensure the costs
associated with these services are included as ``FQHC services'' on the
cost report.
Response: Since we did not make any proposals in this rulemaking
related to revising the regulatory definition of a ``medical visit'' to
permit these services be furnished via telecommunication technologies,
these comments are out of scope. However, we anticipate that the
extension of payment for distant site telehealth services furnished by
RHCs and FQHCs through December 31, 2024, as established in the CAA,
2023, would mitigate concerns regarding gaps in care since it could
provide time for patients transitioning from virtual to in-person
services to come into the RHC or FQHC.
Comment: A commenter stated that given the extension of current RHC
medical telehealth policy through December 31, 2024, and they requested
that CMS permit normal coding instead of billing G2025 for all
allowable Medicare telehealth services. The commenter believes that the
payment can be achieved through appending the modifier code (95) to
these services which could better facilitate data collection of RHC
services performed via telehealth, including proper counting of Annual
Wellness Visits and other preventive services.
Response: We thank the commenter for bringing this to our
attention. We agree that transparency in the services furnished can
improve data collection and inform payment policies and can explore
options that may provide RHCs and FQHCs the ability to report the HCPCS
code that describes the service furnished instead reporting G2025. If
we were to implement such changes in the claims processing systems, we
do not believe that it would change the payment policy, that is,
overall payment would be the same. Therefore, changes in the way RHCs
and FQHCs would report these services and how CMS pays would be
effectuated through sub-regulatory guidance.
Comment: A commenter requested guidance from CMS to clarify for the
RHC community if distant site telehealth services may be provided
outside of the RHC's hours of operations. The commenter stated that
RHCs should not be limited to only offering telehealth during the
physical RHC's hours of operation. The commenter further explained that
they believe this policy limits access to care for safety-net patients.
Response: Currently, RHCs and FQHCs are required to furnish
services during their hours of operation and if services are furnished
at times other than the RHC's or FQHC's posted hours of operation, they
may not be billed to Medicare Part B if the practitioner's compensation
for these services is included in the RHC/FQHC cost report. This policy
is discussed in Pub. 100-02 Medicare Benefit Policy Manual, Chapter 13,
section 40.2 ``Hours of Operation.'' \172\ We appreciate the commenter
bringing this concern to our attention and we can consider for future
rulemaking.
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\172\ https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c13.pdf.
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Comment: One commenter encouraged CMS to not impose requirements
for in-person services beyond what is statutorily required. The
commenter stated that for patients seeking mental health treatment, the
issues which prevent them from accessing care existed prior to the
pandemic and will continue to exist beyond its duration. The commenter
further stated that it is important to ensure the provisions intended
to maintain program integrity do not inhibit patient access to care.
The commenter also stated that providers can utilize their clinical
judgment to assess if a patient requires an in-person visit.
Response: We appreciate the feedback from commenters regarding how
requirements for in-person service when mental health visits are
furnished by RHCs and FQHCs through telecommunication technology may
have on access to care. In the CY 2022 PFS final rule (86 FR 65210) we
finalized a policy that an RHC or FQHC patient must have an in-person
mental health service furnished within 6 months prior to the furnishing
of the telecommunications service and that in general, there must be an
in-person mental health service (without the use of telecommunications
technology) must be provided at least every 12 months while the
beneficiary is receiving services furnished via telecommunications
technology for diagnosis, evaluation, or treatment of mental health
disorders. We stated that this is consistent with policies finalized
for mental health services furnished via telehealth under the PFS, and
that the in-person service requirements apply only to telehealth
services furnished to a patient receiving the service at home.
Regarding concerns that the in-person requirements would pose a
challenge for some beneficiaries, we would like to direct you to Sec.
405.2463(b)(3) that describes the exceptions to the in-person visit
requirements. That is, if the patient and practitioner consider the
risks and burdens of an in-person service and agree that, on balance,
these outweigh the benefits, and the practitioner documents the basis
for that decision in the patient's medical record, then the in-person
visit requirement is not applicable for that 12-month period.
Situations in which the risks and burdens associated with an in-person
service may outweigh the benefit could include, but are not limited to,
instances when an in-person service is likely to cause disruption in
service delivery or has the potential to worsen the patient's
condition(s) (86 FR 65211).
After consideration of public comments, we are finalizing our
proposal to make conforming regulatory text changes based on CAA, 2023
to the applicable RHC and FQHC regulations in 42 CFR part 405, subpart
X, specifically, at Sec. 405.2463, ``What constitutes a visit,'' we
are finalizing revisions to paragraph (b)(3) and, at Sec. 405.2469
``FQHC supplemental payments,'' we are finalizing revisions
[[Page 79067]]
to paragraph (d) to include the delay of the in-person requirements for
mental health visits furnished by RHCs and FQHCs through
telecommunication technology under Medicare beginning January 1, 2025,
as proposed.
b. Direct Supervision via Use of Two-way Audio/Video Communications
Technology
In the CY 2024 PFS proposed rule (88 FR 52397), we discussed direct
supervision. Under Medicare Part B, certain types of services are
required to be furnished under specific minimum levels of supervision
by a physician or practitioner. See section II.D.2.a. for the
discussion regarding direct supervision for services under the PFS. For
RHCs and FQHCs, services and supplies furnished incident to physician's
services are limited to situations in which there is direct physician
supervision of the person performing the service, except for certain
care management services which may be furnished under general
supervision (Sec. 405.2415(a)(5)). The ``incident to'' policy for RHCs
and FQHCs is discussed in Pub. 100-02, chapter 13, section 120.1.
Similar to physician services paid under the PFS, outside the
circumstances of the PHE, direct supervision of RHC and FQHC services
does not require the physician to be present in the same room. However,
the physician must be in the RHC or FQHC and immediately available to
provide assistance and direction throughout the time the incident to
service or supply is being furnished to a beneficiary.
In the CY 2024 PFS proposed rule, we explained that during the
COVID-19 PHE, the modifications that we made to the regulatory
definition of direct supervision for services paid under the PFS were
also applicable to RHCs and FQHCs. We explained in the April 6, 2020
IFC that given the circumstances of the PHE for the COVID-19 pandemic,
we recognized that in some cases, the physical proximity of the
physician or practitioner might present additional exposure risks,
especially for high risk patients isolated for their own protection or
cases where the practitioner has been exposed to the virus but could
otherwise safely supervise from another location using
telecommunications technology. We believed that the same concerns
existed for RHCs and FQHCs. In the April 6, 2020 IFC, we allowed the
supervising professional to be immediately available through virtual
presence using two-way, real time audio-visual technology, instead of
requiring their physical presence (85 FR 19245 and 19246).\173\ When
discussing direct supervision in RHCs and FQHCs, we noted that in
general, we have modified the requirements for direct supervision to
include the use of a virtual supervisory presence through the use of
interactive audio and video telecommunications technology.\174\
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\173\ https://www.govinfo.gov/content/pkg/FR-2020-04-06/pdf/2020-06990.pdf.
\174\ https://www.cms.gov/files/document/03092020-covid-19-faqs-508.pdf.
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We also explained that we believed that extending this definition
of direct supervision for RHCs and FQHCs through December 31, 2024,
would align the timeframe of this policy with many of the previously
discussed PHE-related telehealth policies that were extended under
provisions of the CAA, 2023 and we were concerned about an abrupt
transition to the pre-PHE policy of requiring the physical presence of
the supervising practitioner beginning after December 31, 2023, given
that RHCs and FQHCs have established new patterns of practice during
the PHE for COVID-19. We also believed that RHCs and FQHCs will need
time to reorganize their practices established during the PHE to
reimplement the pre-PHE approach to direct supervision without the use
of audio/video technology. For RHCs and FQHCs, we proposed to continue
to define ``immediate availability'' as including real-time audio and
visual interactive telecommunications through December 31, 2024.
In the absence of evidence that patient safety is compromised by
virtual direct supervision, we stated that we believe that an immediate
reversion to the pre-PHE definition of direct supervision may present a
barrier to access services, such as those furnished incident-to a
physician's service. Therefore, we solicited comments on whether we
should consider extending the definition of ``direct supervision'' to
permit virtual presence beyond December 31, 2024. We explained that
when compared to professionals paid under the PFS, RHCs and FQHCs have
a different model of care and payment structure. Therefore, we
solicited comments from interested parties on potential patient safety
or quality concerns when direct supervision occurs virtually in RHCs
and FQHCs; for instance, if certain types of services are more or less
likely to present patient safety concerns, or if this flexibility would
be more appropriate when certain types of auxiliary personnel are
performing the supervised service. We were also interested in potential
program integrity concerns such as overutilization or fraud and abuse
that interested parties may have in regard to this policy.
We received public comments on these proposals. The following is a
summary of the comments we received and our responses.
Comment: All commenters supported extending the definition of
direct supervision to permit virtual presence beyond December 31, 2024.
Commenters noted that they believe direct supervision has become
increasingly challenging and the option to provide virtual direct
supervision has enhanced the quality and provision of healthcare
services beneficiaries have received in medically underserved, rural
communities. They also noted using audio-visual technology for
supervision during the COVID-19 PHE did not create significant clinical
safety concerns and subsequent formal assessments will confirm the
safety of virtual direct supervision. As workforce challenges exist and
are pronounced in some of their rural communities, commenters believe
this allows RHCs and FQHCs to have a larger community presence,
including longer hours or more days, and stated that they may not be
able to maintain these schedules if a physical presence for direct
supervision is required. Commenters stated that virtual direct
supervision facilitates timely access to services that on-site
personnel could effectively deliver.
Response: We appreciate the commenters' support of extending the
definition of direct supervision to permit virtual presence in RHCs and
FQHCs though December 31, 2024. With regard to extending this
flexibility past December 31, 2024, we may address in future
rulemaking. We also appreciate the positive feedback received from
commenters regarding any potential patient safety, quality, or program
integrity concerns when direct supervision occurs virtually in RHCs and
FQHCs.
After consideration of public comments, we are finalizing our
proposal to extend the definition of direct supervision to permit
virtual presence in RHCs and FQHCs through December 31, 2024.
c. Section 4121 of the CAA, 2023
Section 1861(aa) of the Act provides authority under Medicare Part
B to cover and pay for RHC and FQHC services. Section 1861(aa)(1) of
the Act defines these services as those furnished by physicians,
physician assistants, nurse practitioners, nurse-midwives, qualified
clinical psychologists, clinical social workers, and services and
supplies furnished incident to
[[Page 79068]]
professional services of these practitioners. The conforming regulation
text to these provisions are provided in 42 CFR part 405, subpart X
where we define RHC and FQHC visits as face-to-face encounters between
a patient and one or more RHC or FQHC practitioners during which one or
more RHC or FQHC qualifying services are furnished.
Before passage of CAA, 2023, there was no separate benefit category
under the statute that recognized the professional services of licensed
marriage and family therapists (MFTs) or mental health counselors
(MHCs). As discussed in the CY 2023 PFS final rule (87 FR 69546),
payment for MFTs was only made under the PFS indirectly when an MFT or
MHC performed services as auxiliary personnel incident to the services
of a physician or other practitioner and under general supervision.
This was also true for RHCs and FQHCs, in that MFTs and MHCs were
considered auxiliary personnel and the services they provided were
considered incident to the services of the RHC or FQHC practitioner
(Sec. 405.2413).
Section 4121 of Division FF, Title IV, Subtitle C of the CAA, 2023,
entitled ``Coverage of Marriage and Family Therapist Services and
Mental Health Counselor Services under Part B of the Medicare
Program'', amended section 1861(s)(2) of the Act to establish coverage
of MFT and MHC services (section 1861(s)(2)(II) of the Act). We noted
that section II.J. of this final rule provides a detailed discussion of
the provisions in section 4121(a) of CAA, 2023 including the authority
for coverage of MFT and MHC services, definitions of these
professionals and their services, and payment under the PFS. Section
4121(b) of CAA, 2023 amended section 1861(aa)(1)(B) of the Act by
extending the scope of RHC services to include those furnished by MFTs
and MHCs as eligible for payment, which is incorporated into FQHC
services through section 1861(aa)(3)(A) of the Act. We proposed to
codify payment provisions for MFTs and MHCs under 42 CFR part 405,
subpart X beginning January 1, 2024. That is, RHC and FQHCs will be
paid under the RHC AIR and FQHC prospective payment system (PPS),
respectively, when MFTs and MHCs furnished RHC and FQHC services
defined in Sec. Sec. 405.2411 and 405.2446. As eligible RHC and FQHC
practitioners, MFTs and MHCs will follow the same policies and
supervision requirements as a PA, NP, CNM, CP, and CSW.
In addition, as discussed in section II.J. of this final rule, we
proposed to allow addiction counselors that meet all of the applicable
requirements to enroll in Medicare as MHCs. Therefore, to remain
consistent with payment policies for professionals billing Medicare
under the PFS, we proposed that the definitions established for MFTs
and MHCs under the PFS would also apply for RHCs and FQHCs. In the CY
2023 PFS final rule (87 FR 69735 through 69737), we discussed the
coding and payment for HCPCS code G0323 which describes general BHI
services performed by CPs and CSWs under the PFS. We noted CPs and CSWs
are statutorily authorized to furnish services in RHCs and FQHCs under
sections 1861(aa)(1) and (3) of the Act, respectively, and as described
by Sec. 405.2411(a)(6). We also explained, the payment rate for HCPCS
code G0323 is based on the payment rate for the current general BHI
code, 99484. Therefore, in the CY 2023 PFS final rule (87 FR 69737) we
clarified that when CPs and CSWs provide the services described in
HCPCS code G0323 in an RHC or FQHC, the RHC or FQHC can bill HCPCS code
G0511. We further stated RHCs and FQHCs that furnish general BHI
services are able to bill for this service using HCPCS code G0511,
either alone or with other payable services on an RHC or FQHC claim for
dates of service on or after January 1, 2023.
We noted that in section II.J. of this final rule, we proposed to
revise the code descriptor for HCPCS code G0323 in order to allow MFTs
and MHCs, as well as CPs and CSWs, to be able to bill for this monthly
care integration service. Since MFTs and MHCs are statutorily
authorized to furnish services in RHCs and FQHCs effective January 1,
2024, we proposed to clarify that when MFTs and MHCs provide the
services described in HCPCS code G0323 in an RHC or FQHC, the RHC or
FQHC can bill for this service using HCPCS code G0511. We believe that
this policy aligns with our efforts to be consistent with new services
that are proposed for practitioners billing under the PFS.
We proposed to make several conforming regulatory changes to
applicable RHC and FQHC regulations in 42 CFR part 405, subpart X,
specifically:
At Sec. 405.2401, Scope and definitions, we proposed to
amend the section to add definitions for MFT and MHC;
At Sec. 405.2411, Scope of benefits, we proposed to amend
the section to include MFT and MHC where other RHC and FQHC
practitioners are stated;