[Federal Register Volume 88, Number 130 (Monday, July 10, 2023)]
[Proposed Rules]
[Pages 43654-43817]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-14044]



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Vol. 88

Monday,

No. 130

July 10, 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 409, 410, 414, et al.





Medicare Program; Calendar Year (CY) 2024 Home Health (HH) Prospective 
Payment System Rate Update; HH Quality Reporting Program Requirements; 
HH Value-Based Purchasing Expanded Model Requirements; Home Intravenous 
Immune Globulin Items and Services; Hospice Informal Dispute Resolution 
and Special Focus Program Requirements, Certain Requirements for 
Durable Medical Equipment Prosthetics and Orthotics Supplies; and 
Provider and Supplier Enrollment Requirements; Proposed Rule

  Federal Register / Vol. 88, No. 130 / Monday, July 10, 2023 / 
Proposed Rules  

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 409, 410, 414, 424, 484, 488, and 489

[CMS-1780-P]
RIN 0938-AV03


Medicare Program; Calendar Year (CY) 2024 Home Health (HH) 
Prospective Payment System Rate Update; HH Quality Reporting Program 
Requirements; HH Value-Based Purchasing Expanded Model Requirements; 
Home Intravenous Immune Globulin Items and Services; Hospice Informal 
Dispute Resolution and Special Focus Program Requirements, Certain 
Requirements for Durable Medical Equipment Prosthetics and Orthotics 
Supplies; and Provider and Supplier Enrollment Requirements

AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of 
Health and Human Services (HHS).

ACTION: Proposed rule.

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SUMMARY: This proposed rule would set forth routine updates to the 
Medicare home health payment rates for calendar year (CY) 2024 in 
accordance with existing statutory and regulatory requirements. This 
rule would--provide information on home health utilization trends and 
solicits comments regarding access to home health aide services; 
implement home health payment-related changes; rebase and revise the 
home health market basket and revise the labor-related share; codify 
statutory requirements for disposable negative pressure wound therapy 
(dNPWT); and implement the new items and services payment for the home 
intravenous immune globulin (IVIG) benefit. In addition, it proposes--
changes to the Home Health Quality Reporting Program (HH QRP) 
requirements and the expanded Home Health Value-Based Purchasing 
(HHVBP) Model; to implement the new Part B benefit for lymphedema 
compression treatment items, codify the Medicare definition of brace, 
and make other codification changes based on recent legislation; to add 
an informal dispute resolution (IDR) and special focus program (SFP) 
for hospice programs; to codify DMEPOS refill policy; and to revise 
Medicare provider and supplier enrollment requirements.

DATES: To be assured consideration, comments must be received at one of 
the addresses provided in the ADDRESSES section, no later than 5 p.m. 
EDT on August 29, 2023.

ADDRESSES: In commenting, please refer to file code CMS-1780-P. Because 
of staff and resource limitations, we cannot accept comments by 
facsimile (FAX) transmission.
    Comments, including mass comment submissions, must be submitted in 
one of the following three ways (please choose only one of the ways 
listed):
    1. Electronically. You may (and we encourage you to) submit 
electronic comments on this regulation to https://www.regulations.gov. 
Follow the instructions under the ``submit a comment'' tab.
    2. By regular mail. You may mail written comments to the following 
address ONLY: Centers for Medicare & Medicaid Services, Department of 
Health and Human Services, Attention: CMS-1780-P, P.O. Box 8013, 
Baltimore, MD 21244-8013.
    Please allow sufficient time for mailed comments to be received 
before the close of the comment period.
    3. By express or overnight mail. You may send written comments via 
express or overnight mail to the following address ONLY: Centers for 
Medicare & Medicaid Services, Department of Health and Human Services, 
Attention: CMS-1780-P, Mail Stop C4-26-05, 7500 Security Boulevard, 
Baltimore, MD 21244-1850.
    For information on viewing public comments, we refer readers to the 
beginning of the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: 
    Brian Slater, (410) 786-5229, for home health and home IVIG payment 
inquiries.
    For general information about the Home Health Prospective Payment 
System (HH PPS), send your inquiry via email to 
[email protected].
    For information about the Home Health Quality Reporting Program (HH 
QRP), send your inquiry via email to [email protected].
    Frank Whelan (410) 786-1302, for Medicare provider and supplier 
enrollment inquiries.
    For more information about the expanded Home Health Value-Based 
Purchasing Model, please visit the Expanded HHVBP Model web page at 
https://innovation.cms.gov/innovation-models/expanded-home-health-value-based-purchasing-model.
    For more information about the hospice informal dispute resolution 
and special focus program, send your inquiry to 
[email protected].

SUPPLEMENTARY INFORMATION: 
    Inspection of Public Comments: All comments received before the 
close of the comment period are available for viewing by the public, 
including any personally identifiable or confidential business 
information that is included in a comment. We post all comments 
received before the close of the comment period on the following 
website as soon as possible after they have been received: https://www.regulations.gov/. Follow the search instructions on that website to 
view public comments.

Table of Contents

I. Executive Summary
    A. Purpose and Legal Authority
    B. Summary of the Provisions of This Proposed Rule
    C. Summary of Costs, Transfers, and Benefits
II. Home Health Prospective Payment System
    A. Overview of the Home Health Prospective Payment System
    B. Monitoring the Effects of the Implementation of PDGM
    C. Proposed Provisions for CY 2024 Payment Under the HH PPS
III. Home Health Quality Reporting Program (HH QRP)
    A. Background and Statutory Authority
    B. General Considerations Used for the Selection of Quality 
Measures for the HH QRP
    C. Quality Measures Currently Adopted for the CY 2024 HH QRP
    D. HH QRP Quality Measure Proposals Beginning With the CY 2025 
HH QRP
    E. Form, Manner, and Timing of Data Submission Under the HH QRP
    F. Policies Regarding Public Display of Measure Data for the HH 
QRP
    G. Health Equity Update
    H. Proposal To Codify HH QRP Data Completion Thresholds
    I. Principles for Selecting and Prioritizing HH QRP Quality 
Measures and Concepts Under Consideration for Future Years: Request 
for Information (RFI)
IV. Proposed Changes to the Expanded Home Health Value-Based 
Purchasing (HHVBP) Model
    A. Background
    B. Proposed Changes to the Applicable Measure Set
    C. Proposed Changes to the Appeals Process
    D. Public Reporting Reminder
    E. Health Equity Update
V. Medicare Home Intravenous Immune Globulin (IVIG) Items and 
Services
    A. General Background
    B. Proposed Scope of Expanded IVIG Benefit
    C. Proposed IVIG Administration Items and Services Payment
    D. Proposed Home IVIG Items and Services Payment Rate
    E. Billing Procedures for Home IVIG Items and Services
VI. Hospice Informal Dispute Resolution and Special Focus Program

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    A. Background and Statutory Authority
    B. Proposed Regulatory Provisions
VII. Proposed Changes Regarding Durable Medical Equipment, 
Prosthetics, Orthotics, and Supplies (DMEPOS)
    A. Medicare Durable Medical Equipment, Prosthetics, Orthotics, 
and Supplies (DMEPOS) Competitive Bidding Program (CBP)
    B. Scope of the Benefit and Payment for Lymphedema Compression 
Treatment Items
    C. Definition of Brace
    D. Documentation Requirements for Durable Medical Equipment, 
Prosthetics, Orthotics, and Supplies Products Supplied as Refills to 
the Original Order
VIII. Proposed Changes to the Provider and Supplier Enrollment 
Requirements
    A. Background
    B. Proposed Provisions
IX. Collection of Information Requirements
    A. Statutory Requirement for Solicitation of Comments
    B. Information Collection Requirements (ICRs)
    C. Submission of PRA-Related Comments
X. Regulatory Impact Analysis
    A. Statement of Need
    B. Overall Impact
    C. Detailed Economic Analysis
    D. Regulatory Review Cost Estimation
    E. Alternatives Considered
    F. Accounting Statements and Tables
    G. Regulatory Flexibility Act (RFA)
    H. Unfunded Mandates Reform Act (UMRA)
    I. Federalism
    J. Conclusion
Regulations Text

I. Executive Summary

A. Purpose and Legal Authority

1. Home Health Prospective Payment System (HH PPS)
    As required under section 1895(b) of the Social Security Act (the 
Act), this proposed rule would update the payment rates for home health 
agencies (HHAs) for CY 2024. In this proposed rule we include analysis 
on home health utilization and solicit comments related to access to 
home health aide services. This rule also provides analysis determining 
the difference between assumed versus actual behavior change on 
estimated aggregate expenditures for home health payments as result of 
the change in the unit of payment to 30 days and the implementation of 
the PDGM case-mix adjustment methodology, and proposes a permanent 
prospective adjustment to the CY 2024 home health payment rate. In 
addition, this rule proposes to recalibrate the PDGM case-mix weights 
and update the LUPA thresholds, functional impairment levels, and 
comorbidity adjustment subgroups under section 1895(b)(4)(A)(i) and 
(b)(4)(B) of the Act for 30-day periods of care in CY 2024. This rule 
proposes to rebase and revise the home health market basket and 
proposes to revise the labor-related share. Additionally, this rule 
proposes to codify statutory requirements for dNPWT and updates the CY 
2024 fixed-dollar loss ratio (FDL) for outlier payments (so that 
outlier payments as a percentage of estimated total payments are not to 
exceed 2.5 percent, as required by section 1895(b)(5)(A) of the Act).
2. Home Health (HH) Quality Reporting Program (QRP)
    In accordance with the statutory authority at section 
1895(b)(3)(B)(v) of the Act, we are proposing updated policies, the 
codification of the previously finalized 90 percent Outcome and 
Assessment Information Set (OASIS) data completion threshold policy in 
the Code of Federal Regulations (CFR) and the public reporting of four 
measures. We are also including a request for information on future HH 
QRP measure concepts and an update on health equity in the HH QRP.
3. Expanded Home Health Value-Based Purchasing (HHVBP) Model
    In accordance with the statutory authority at section 1115A of the 
Act, we are proposing updated policies, including the codification of 
previously finalized measure removal factors, changes to the applicable 
measure set, updating the Model baseline year, and an amendment to the 
appeals process for the expanded HHVBP Model. We are also including 
updates on health equity and public reporting.
4. Home Intravenous Immune Globulin (IVIG) Items and Services
    As required under Division FF, section 4134 of the Consolidated 
Appropriations Act, 2023 (CAA, 2023), this proposed rule would 
implement coverage and payment for items and services related to the 
administration of IVIG in the home of a patient with a diagnosed 
primary immune deficiency disease (PIDD).
5. Hospice Informal Dispute Resolution and Special Focus Program
    As required under Division CC, section 407 of the Consolidated 
Appropriations Act of 2021 (CAA 2021), this proposed rule would 
implement a special focus program (SFP) for poor performing hospices 
that includes the SFP algorithm (including data sources) to identify 
indicators of hospice poor performance, the criteria for selection and 
completion of the SFP, hospice termination from Medicare, and public 
reporting of the SFP. We are also proposing regulations to implement an 
informal dispute resolution (IDR) process to provide hospice programs 
an informal opportunity to resolve disputes related to condition-level 
survey findings for those hospice programs that are seeking 
recertification for continued participation in Medicare.
6. Durable Medical Equipment, Prosthetics, Orthotics, and Supplies 
Products and CAA 2023-Related Changes
    Section 3712 of the Coronavirus Aid, Relief, and Economic Security 
Act (CARES) Act (Pub. L. 116-136, March 27, 2020) https://www.govinfo.gov/link/plaw/116/public/136 requires that Medicare payment 
rates for durable medical equipment (DME) in areas other than rural and 
noncontiguous areas during the coronavirus disease 2019 (COVID-19) 
public health emergency (PHE) be equal to 75 percent of the adjusted 
payment amounts (based on the DME competitive bidding program 
information), and 25 percent of the unadjusted fee schedule amounts. 
The regulations at Sec.  414.210(g)(9)(v) codified these payment rates 
for the duration of the PHE. Section 4139 of the Consolidated 
Appropriations Act (CAA), 2023 (Pub. L. 117-328, December 29, 2022) 
requires payment based on these rates through the end of the COVID-19 
PHE or December 31, 2023, whichever is later. We are proposing to make 
changes to the regulations to codify these payment rates through the 
end of the COVID-19 PHE or unless otherwise specified by law.
    The scope of the benefit and payment for lymphedema compression 
treatment items in section 4133 of the CAA, 2023 adds section 
1861(s)(2)(JJ) to the Act, adding the Medicare Part B benefit for 
lymphedema compression treatment items effective January 1, 2024. This 
rule would address the scope of the new benefit by defining what 
constitutes a standard or custom fitted gradient compression garment 
and determining what other compression items may exist that are used 
for the treatment of lymphedema and would fall under the new benefit.
    This rule would also implement section 1834(z) of the Act in 
establishing payment amounts for items covered under the new benefit 
and frequency limitations for lymphedema compression treatment items. 
CMS expects to conduct outreach for individuals with Medicare and issue 
provider education regarding this benefit.
    The definition of brace in section 1861(s)(9) of the Act provides 
coverage

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under Part B for leg, arm, back, and neck braces. This rule would 
codify the existing definition of a brace found in the Medicare Benefit 
Policy Manual (CMS 100-02) and clarify that this definition encompasses 
newer, technology-powered devices.
7. Documentation Requirements for Durable Medical Equipment, 
Prosthetics, Orthotics, and Supplies Products Supplied as Refills to 
the Original Order
    Section 1893(b)(1) of the Act, authorizes ``[r]eview of activities 
of providers of services or other individuals and entities furnishing 
items and services for which payment may be made under this title . . . 
including medical and utilization review . . .''. The requirement for 
documentation to support DMEPOS refills originally arose in response to 
concerns related to auto-shipments and delivery of DMEPOS products that 
may no longer be needed or not needed at the same level of frequency/
volume. We are proposing to codify our long-standing refill policy, 
with some changes. We propose to require documentation indicating that 
the beneficiary confirmed the need for the refill within the 30-day 
period prior to the end of the current supply. We propose to codify our 
requirement that delivery of DMEPOS items (that is, date of service) be 
no sooner than 10 calendar days before the expected end of the current 
supply. We seek comments for consideration in future rulemaking on ways 
to balance beneficiary burden with the potential risks/burdens of not 
verifying the beneficiary's actual need for recurring supplies for 
certain individuals with permanent conditions.
8. Provider and Supplier Enrollment Requirements
    The purpose of our provider enrollment provisions is to strengthen 
and clarify certain aspects of the provider enrollment process. This 
includes, but is not limited to: (1) subjecting a greater number of 
providers and suppliers, such as hospices, to the highest level of 
screening, which includes fingerprinting all 5 percent or greater 
owners of these providers and suppliers; (2) applying the change in 
majority ownership (CIMO) provisions in 42 CFR 424.550(b) to hospices; 
and (3) reducing the period of Medicare non-billing for which a 
provider or supplier can be deactivated under Sec.  424.540(a)(1) from 
12 months to 6 months. These changes are necessary to help ensure that 
payments are made only to qualified providers and suppliers and/or that 
owners of these entities are carefully screened. We believe that 
fulfilling both of these objectives would assist in protecting the 
Trust Funds and Medicare beneficiaries.

B. Summary of the Provisions of This Proposed Rule

1. Home Health Prospective Payment System (HH PPS)
    In section II.B.1. of this proposed rule, we provide monitoring and 
data analysis on PDGM utilization for CYs 2020, 2021, and 2022. In this 
section we also solicit comments related to access to home health aide 
services. In section II.C.1. of this rule, we provide analysis 
determining the difference between assumed versus actual behavior 
change on estimated aggregate expenditures for home health payments as 
result of the change in the unit of payment to 30 days and the 
implementation of the PDGM case-mix adjustment methodology; and a 
proposal to apply a permanent prospective adjustment of -5.653 percent 
to the CY 2024 home health payment rate.
    In section II.C.2. of this proposed rule, we explain plans to 
recalibrate the PDGM case-mix weights, LUPA thresholds, functional 
levels, and comorbidity adjustment subgroups for CY 2024.
    In section II.C.3. of this rule we set out proposals to rebase and 
revise the home health market basket to reflect a 2021 base year. We 
propose to use this 2021-based home health market basket to calculate 
the home health payment update percentage for CY 2024 as well as to 
revise the labor-related share.
    In section II.C.4. of this rule, we detail proposals to update the 
home health wage index, the CY 2024 national, standardized 30-day 
period payment rates, and the CY 2024 national per-visit payment 
amounts by the home health payment update percentage. The proposed home 
health payment update percentage for CY 2024 is 2.7 percent. 
Additionally, this rule proposes the CY 2024 FDL ratio to ensure that 
aggregate outlier payments do not exceed 2.5 percent of the total 
aggregate payments, as required by section 1895(b)(5)(A) of the Act.
    In section II.C.5 of this rule, we discuss our proposal to codify 
statutory payment changes for negative pressure wound therapy using a 
disposable device (dNPWT).
2. Home Health Quality Reporting Program (HH QRP)
    In section III. of this proposed rule, we are proposing the 
adoption of the measure ``COVID-19 Vaccine: Percent of Patients/
Residents Who Are Up to Date'' (Patient/Resident COVID-19 Vaccine) to 
the HH QRP beginning with the CY 2025 HH QRP. CMS also proposes to 
adopt the ``Functional Discharge Score'' (DC Function) measure to the 
HH QRP beginning with the CY 2025 HH QRP. With the addition of the 
Discharge Function measure, we propose to remove the measure 
``Application of Percent of Long-Term Care Hospital (LTCH) Patients 
with an Admission and Discharge Functional Assessment and a Care Plan 
That Addresses Function'' (Application of Functional Assessment/Care 
Plan) from the HH QRP beginning with the CY 2025 HH QRP. CMS 
additionally propose the removal of two OASIS items no longer necessary 
for collection, the M0110--Episode Timing and M2220--Therapy Needs 
items. We are also proposing technical changes to Sec.  484.245(b) to 
codify our requirement that HHAs must meet or exceed a data submission 
threshold set at 90 percent of all required OASIS and submit the data 
through the CMS designated data submission systems. Lastly, we seek 
input on future HH QRP measure concepts and provide updates on HH QRP 
health equity initiatives.
3. Expanded Home Health Value Based Purchasing (HHVBP) Model
    In section IV. of this proposed rule, we discuss our proposal to 
codify the HHVBP measure removal factors at Sec.  484.380. We are 
proposing to remove five and add three quality measures to the 
applicable measure set. Along with the proposed revisions to the 
current measure set, we propose to revise the weights of the individual 
measures within the OASIS-based measure category and within the claims-
based measure category starting in the CY 2025 performance year. We are 
proposing to update the Model baseline year from CY 2022 to CY 2023 
starting in the CY 2025 performance year to enable CMS to measure 
competing HHAs performance on benchmarks and achievement thresholds 
that are more current for all applicable measures. Additionally, we are 
amending the appeals process such that reconsideration decisions may be 
reviewed by the Administrator. We are including an update to the RFI, 
Future Approaches to Health Equity in the Expanded HHVBP Model, that 
was published in the CY 2023 HH PPS rule. We will also include an 
update that reminds stakeholders that we will begin public reporting of 
HHVBP performance data on or after December 1, 2024.

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4. Home Intravenous Immune Globulin (IVIG) Items and Services
    As required under Division FF, section 4134 of the Consolidated 
Appropriations Act, 2023 (CAA, 2023), section V. of this rule proposes 
regulations to implement coverage and payment of items and services 
related to administration of IVIG in a patient's home for a patient 
with PIDD.
5. Hospice Informal Dispute Resolution and Special Focus Program
    In section VI. of this proposed rule, we discuss our proposal for a 
new hospice informal dispute resolution (IDR) process at Sec.  488.1130 
to align with the process that is available for home health agencies 
(HHAs). We are proposing the hospice IDR to address disputes related to 
condition-level survey findings following a hospice program's receipt 
of the official survey statement of deficiencies. The IDR will provide 
hospice programs an informal opportunity to resolve disputes in the 
survey findings for those hospice programs that are seeking 
recertification from the State Survey Agency (SA) or reaccreditation 
from an accrediting organization (AO) for continued participation in 
Medicare. Additionally, the IDR may be initiated for those hospice 
programs that are currently under SA monitoring (either through a 
complaint investigation or validation survey) and those in the SFP. In 
section VII we discuss our proposal to add the hospice Special Focus 
Program (SFP) at Sec.  488.1135. In the proposed rule, we include the 
SFP algorithm (including data sources) to identify indicators of 
hospice poor performance, the criteria for selection and completion of 
the SFP, hospice termination from Medicare, and public reporting of the 
SFP. In response to previous comments urging CMS to seek technical 
expert panel (TEP) recommendations to better inform the development of 
the SFP, a TEP was convened to gain input from key stakeholders on 
various aspects of the SFP proposed in this rule. We propose the 
hospice SFP will commence beginning the effective date of the rule with 
implementation during CY 2024. We propose to periodically review the 
effectiveness of the methodology and the algorithm.
6. Durable Medical Equipment, Prosthetics, Orthotics, and Supplies 
Products and CAA 2023 Related Changes
    In section VII.A.3. of this rule, we discuss our proposal to make 
conforming changes to Sec.  414.210(g)(9), consistent with section 
4139(a) and 4139(b) of the CAA, 2023. First, section 4139 of the CAA, 
2023 does not change the current policy under Sec.  414.210(g)(9)(iii) 
of paying for DMEPOS items and services furnished in rural and non-
contiguous non-competitive bidding areas (CBAs) based on a 50/50 blend 
of adjusted and unadjusted fee schedule amounts through the duration of 
the PHE for COVID-19.
    As a result, we are proposing to revise Sec.  414.210(g)(9)(iii), 
to state that for items and services furnished in rural areas and non-
contiguous areas (Alaska, Hawaii, and U.S. territories) with dates of 
service from June 1, 2018 through the duration of the emergency period 
described in section 1135(g)(1)(B) of the Act (42 U.S.C. 1320b-
5(g)(1)(B)) or December 31, 2023, whichever is later, based on the fee 
schedule amount for the area is equal to 50 percent of the adjusted 
payment amount established under this section and 50 percent of the 
unadjusted fee schedule amount.
    We are proposing to revise Sec.  414.210(g)(9)(v) to state that for 
items and services furnished in areas other than rural or noncontiguous 
areas with dates of service from March 6, 2020 through December 31, 
2023 or through the remainder of the duration of the emergency period 
described in section 1135(g)(1)(B) of the Act (42 U.S.C. 1320b-
5(g)(1)(B)), whichever is later, the fee schedule amount for the area 
is equal to 75 percent of the adjusted payment amount established under 
this section and 25 percent of the unadjusted fee schedule amount.
    We are proposing to remove outdated text from Sec.  
414.210(g)(9)(v) that states ``for items and services furnished in 
areas other than rural or noncontiguous areas with dates of service 
from the expiration date of the emergency period described in section 
1135(g)(1)(B) of the Act (42 U.S.C. 1320b-5(g)(1)(B)), through December 
31, 2020, the fee schedule amount for the area is equal to 100 percent 
of the adjusted payment amount established under this section.''
    We are proposing to revise Sec.  414.210(g)(9)(vi) to state that 
for items and services furnished in all areas with dates of service on 
or after January 1, 2024, or the date immediately following the 
duration of the emergency period described in section 1135(g)(1)(B) of 
the Act, whichever is later, the fee schedule amount for the area is 
equal to the adjusted payment amount established under paragraph (g) of 
this section.
    We are proposing to make conforming changes to Sec.  414.210(g)(2) 
for the rural and non-contiguous areas in order to specify the December 
31, 2023 date specified in section 4139 of the CAA, 2023.
    In section VII.B.8. of this rule, we discuss our proposal to amend 
42 CFR 410.36(a) to add paragraph (4) and the following new category of 
medical supplies, appliances, and devices covered under Medicare Part 
B; Lymphedema compression items including: standard and custom fitted 
gradient compression garments; gradient compression wraps with 
adjustable straps; compression bandaging systems; and other items 
determined to be lymphedema compression treatment items under the 
process established under Sec.  414.1670. Other covered items would 
include accessories such as zippers in garments, liners worn under 
garments or wraps with adjustable straps, and padding or fillers that 
are necessary for the effective use of a gradient compression garment 
or wrap with adjustable straps.
    We are proposing to modify and add to the existing HCPCS codes for 
lymphedema compression treatment items.
    We are proposing to add Sec.  414.1670 under new subpart Q and use 
the same process described in Sec.  414.240 to obtain public 
consultation on preliminary benefit category determinations and payment 
determinations for new lymphedema compression treatment items.
    We are proposing to add a new subpart Q under the regulations at 42 
CFR part 414 titled, ``Payment for Lymphedema Compression Treatment 
Items'' to implement the provisions of section 1834(z) of the Act.
    We are proposing to add Sec.  414.1600 to explain the purpose and 
definitions found in subpart Q.
    We are also proposing to add Sec.  414.1660 to address continuity 
of pricing when HCPCS codes for lymphedema compression treatment items 
are divided or combined.
    We are proposing to add Sec.  414.1680 and the following frequency 
limitations for lymphedema compression treatment items
    We are proposing to revise the regulations for competitive bidding 
under at 42 CFR part 414, subpart F to include lymphedema compression 
treatment items under the competitive bidding program as mandated by 
section 1847(a)(2)(D) of the Act. We propose to add lymphedema 
compression treatment items to the definition of item at Sec.  414.402. 
We are proposing to revise Sec.  414.408 to indicate that payment for 
these items would be calculated on a lump sum purchase basis and 
payment under the program would be made in accordance with any 
frequency

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limitations established under subpart Q in accordance with section 
1834(z)(2) of the Act. We are also proposing to add lymphedema 
compression treatment items to Sec.  414.412 to address limiting bids 
submitted under the program using the payment established under subpart 
Q.
    We are proposing to add Sec.  414.1690 indicating that the payment 
amounts established under Sec.  414.1650(b) may be adjusted using 
information on the payment determined for lymphedema compression 
treatment items as part of implementation of the competitive bidding 
programs under subpart F using the methodologies set forth at Sec.  
414.210(g).
    In section VII.C.3. of this rule, we discuss our proposal to amend 
the regulations at 42 CFR 410.2 to add the definition of brace and to 
add clarification at Sec.  410.36(a)(3)(i) for the purpose of 
determining the Medicare Part B benefit and scope for leg, arm, back, 
and neck braces and making benefit category determinations regarding 
specific items in accordance with the review process for benefit 
category and payment determinations under Sec.  414.240.
7. Documentation Requirements for Durable Medical Equipment, 
Prosthetics, Orthotics, and Supplies Products Supplied as Refills to 
the Original Order
    We propose updating the refill documentation requirements such that 
a beneficiary affirmation would need to be documented by the supplier. 
We propose to require documentation indicating that the beneficiary 
confirmed the need for the refill within the 30-day period prior to the 
end of the current supply. We propose to codify our requirement that 
delivery of DMEPOS items (that is, date of service) be no sooner than 
10 calendar days before the expected end of the current supply. There 
is no associated paperwork burden as the burden is already accounted 
for and approved by the Office of Management and Budget under OMB 
control number 0938-0969 (CMS-10417).
8. Provider and Supplier Enrollment Requirements
    We are proposing a number of changes to our Medicare provider and 
supplier enrollment requirements. These include, but are not limited 
to: (1) provisions related to hospice enrollment and ownership; and (2) 
deactivation of providers and suppliers.

C. Summary of Costs, Transfers, and Benefits

BILLING CODE 4120-01-P

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[GRAPHIC] [TIFF OMITTED] TP10JY23.003


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[GRAPHIC] [TIFF OMITTED] TP10JY23.004

BILLING CODE 4120-01-C

II. Home Health Prospective Payment System

A. Overview of the Home Health Prospective Payment System

1. Statutory Background
    Section 1895(b)(1) of the Act requires the Secretary to establish a 
Home Health Prospective Payment System (HH PPS) for all costs of home 
health services paid under Medicare. Section 1895(b)(2) of the Act 
requires that, in defining a prospective payment amount, the Secretary 
will consider an appropriate unit of service and the number, type, and 
duration of visits provided within that unit, potential changes in the 
mix of services provided within that unit and their cost, and a general 
system design that provides for continued access to quality services. 
In accordance with the statute, as amended by the Balanced Budget Act 
of 1997 (BBA), (Pub. L. 105-33, enacted August 5, 1997) we published a 
final rule in the July 3, 2000 Federal Register (65 FR 41128) to 
implement the HH PPS legislation.
    Section 5201(c) of the Deficit Reduction Act of 2005 (DRA) (Pub. L. 
109-171, enacted February 8, 2006) added new section 1895(b)(3)(B)(v) 
to the Act, requiring home health agencies (HHAs) to submit data for 
purposes of measuring health care quality, and linking the quality data 
submission to the annual applicable home health payment update 
percentage increase. This data submission requirement is applicable for 
CY 2007 and each subsequent year. If an HHA does not submit quality 
data, the home health market basket percentage increase is reduced by 2 
percentage points. In the November 9, 2006 Federal Register (71 FR 
65935), we published a final rule to implement the pay-for-reporting 
requirement of the DRA, which was codified at Sec.  484.225(h) and (i) 
in

[[Page 43661]]

accordance with the statute. The pay-for-reporting requirement was 
implemented on January 1, 2007.
    Section 51001(a)(1)(B) of the Bipartisan Budget Act of 2018 (BBA of 
2018) (Pub. L. 115-123) amended section 1895(b) of the Act to require a 
change to the home health unit of payment to 30-day periods beginning 
January 1, 2020. Section 51001(a)(2)(A) of the BBA of 2018 added a new 
subclause (iv) under section 1895(b)(3)(A) of the Act, requiring the 
Secretary to calculate a standard prospective payment amount (or 
amounts) for 30-day units of service furnished that end during the 12-
month period beginning January 1, 2020, in a budget neutral manner, 
such that estimated aggregate expenditures under the HH PPS during CY 
2020 are equal to the estimated aggregate expenditures that otherwise 
would have been made under the HH PPS during CY 2020 in the absence of 
the change to a 30-day unit of service. Section 1895(b)(3)(A)(iv) of 
the Act requires that the calculation of the standard prospective 
payment amount (or amounts) for CY 2020 be made before the application 
of the annual update to the standard prospective payment amount as 
required by section 1895(b)(3)(B) of the Act.
    Additionally, section 1895(b)(3)(A)(iv) of the Act requires that in 
calculating the standard prospective payment amount (or amounts), the 
Secretary must make assumptions about behavior changes that could occur 
as a result of the implementation of the 30-day unit of service under 
section 1895(b)(2)(B) of the Act and case-mix adjustment factors 
established under section 1895(b)(4)(B) of the Act. Section 
1895(b)(3)(A)(iv) of the Act further requires the Secretary to provide 
a description of the behavior assumptions made in notice and comment 
rulemaking. CMS finalized these behavior assumptions in the CY 2019 HH 
PPS final rule with comment period (83 FR 56461).
    Section 51001(a)(2)(B) of the BBA of 2018 also added a new 
subparagraph (D) to section 1895(b)(3) of the Act. Section 
1895(b)(3)(D)(i) of the Act requires the Secretary annually to 
determine the impact of differences between assumed behavior changes, 
as described in section 1895(b)(3)(A)(iv) of the Act, and actual 
behavior changes on estimated aggregate expenditures under the HH PPS 
with respect to years beginning with 2020 and ending with 2026. Section 
1895(b)(3)(D)(ii) of the Act requires the Secretary, at a time and in a 
manner determined appropriate, through notice and comment rulemaking, 
to provide for one or more permanent increases or decreases to the 
standard prospective payment amount (or amounts) for applicable years, 
on a prospective basis, to offset for such increases or decreases in 
estimated aggregate expenditures, as determined under section 
1895(b)(3)(D)(i) of the Act. Additionally, section 1895(b)(3)(D)(iii) 
of the Act requires the Secretary, at a time and in a manner determined 
appropriate, through notice and comment rulemaking, to provide for one 
or more temporary increases or decreases to the payment amount for a 
unit of home health services for applicable years, on a prospective 
basis, to offset for such increases or decreases in estimated aggregate 
expenditures, as determined under section 1895(b)(3)(D)(i) of the Act. 
Such a temporary increase or decrease shall apply only with respect to 
the year for which such temporary increase or decrease is made, and the 
Secretary shall not take into account such a temporary increase or 
decrease in computing the payment amount for a unit of home health 
services for a subsequent year. Finally, section 51001(a)(3) of the BBA 
of 2018 amends section 1895(b)(4)(B) of the Act by adding a new clause 
(ii) to require the Secretary to eliminate the use of therapy 
thresholds in the case-mix system for CY 2020 and subsequent years.
    Division FF, section 4136 of the Consolidated Appropriations Act, 
2023 (CAA, 2023) amended section 1834(s)(3)(A) of the Act to require 
that, beginning with 2024, the separate payment for furnishing negative 
pressure wound therapy (NPWT) be for just the device and not for 
nursing and therapy services. Payment for nursing and therapy services 
are to be included as part of payments under the HH PPS. The separate 
payment for 2024 is to be equal to the supply price used to determine 
the relative value for the service under the Medicare Physician Fee 
Schedule (as of January 1, 2022) for the applicable disposable device 
updated by the percentage increase in the Consumer Price Index for All 
Urban Consumers (CPI-U). The separate payment for 2025 and each 
subsequent year is to be the payment amount for the previous year 
updated by the percentage increase in the CPI-U (United States city 
average) for the 12-month period ending in June of the previous year 
minus the productivity adjustment as described in section 
1886(b)(3)(B)(xi)(II) for such year. The CAA, 2023 also added section 
1834(s)(4) of the Act to require that beginning with 2024, as part of 
submitting claims for the separate payment, the Secretary shall accept 
and process claims submitted using the type of bill that is most 
commonly used by home health agencies to bill services under a home 
health plan of care.
2. Current System for Payment of Home Health Services
    For home health periods of care beginning on or after January 1, 
2020, Medicare makes payment under the HH PPS on the basis of a 
national, standardized 30-day period payment rate that is adjusted for 
case-mix and area wage differences in accordance with section 
51001(a)(1)(B) of the BBA of 2018. The national, standardized 30-day 
period payment rate includes payment for the six home health 
disciplines (skilled nursing, home health aide, physical therapy, 
speech-language pathology, occupational therapy, and medical social 
services). Payment for non-routine supplies (NRS) is also part of the 
national, standardized 30-day period rate. Durable medical equipment 
(DME) provided as a home health service, as defined in section 1861(m) 
of the Act, is paid the fee schedule amount or is paid through the 
competitive bidding program and such payment is not included in the 
national, standardized 30-day period payment amount. Additionally, the 
30-day period payment rate does not include payment for certain 
injectable osteoporosis drugs and negative pressure wound therapy 
(NPWT) using a disposable device (though this rule is proposing changes 
to this provision pursuant to section 4136 of the CAA, 2023), but such 
drug and services must be billed by the HHA while a patient is under a 
home health plan of care, as the law requires consolidated billing of 
osteoporosis drugs and NPWT using a disposable device.
    To better align payment with patient care needs and to better 
ensure that clinically complex and ill beneficiaries have adequate 
access to home health care, in the CY 2019 HH PPS final rule with 
comment period (83 FR 56406), we finalized case-mix methodology 
refinements through the Patient-Driven Groupings Model (PDGM) for home 
health periods of care beginning on or after January 1, 2020. The PDGM 
did not change eligibility or coverage criteria for Medicare home 
health services, and as long as the individual meets the criteria for 
home health services as described at 42 CFR 409.42, the individual can 
receive Medicare home health services, including therapy services. For 
more information about the role of therapy services under the PDGM, we 
refer readers to the Medicare Learning Network (MLN) Matters article 
SE20005 available at https://www.cms.gov/

[[Page 43662]]

regulations-and-guidanceguidancetransmittals2020-transmittals/se20005. 
To adjust for case-mix for 30-day periods of care beginning on and 
after January 1, 2020, the HH PPS uses a 432-category case-mix 
classification system to assign patients to a home health resource 
group (HHRG) using patient characteristics and other clinical 
information from Medicare claims and the Outcome and Assessment 
Information Set (OASIS) assessment instrument. These 432 HHRGs 
represent the different payment groups based on five main case-mix 
categories under the PDGM, as shown in Figure B1. Each HHRG has an 
associated case-mix weight that is used in calculating the payment for 
a 30-day period of care. For periods of care with visits less than the 
low-utilization payment adjustment (LUPA) threshold for the HHRG, 
Medicare pays national per-visit rates based on the discipline(s) 
providing the services. Medicare also adjusts the national standardized 
30-day period payment rate for certain intervening events that are 
subject to a partial payment adjustment. For certain cases that exceed 
a specific cost threshold, an outlier adjustment may also be available.
    Under this case-mix methodology, case-mix weights are generated for 
each of the different PDGM payment groups by regressing resource use 
for each of the five categories (admission source, timing, clinical 
grouping, functional impairment level, and comorbidity adjustment) 
using a fixed effects model. A detailed description of each of the 
case-mix variables under the PDGM have been described previously, and 
we refer readers to the CY 2021 HH PPS final rule (85 FR 70303 through 
70305).
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[[Page 43663]]



B. Monitoring the Effects of the Implementation of PDGM

1. Routine PDGM Monitoring
    CMS routinely analyzes Medicare home health benefit utilization, 
including but not limited to, overall total 30-day periods of care and 
average periods of care per HHA user; distribution of the type of 
visits in a 30-day period of care; the percentage of periods that 
receive the LUPA; estimated costs; the percentage of 30-day periods of 
care by clinical group, comorbidity adjustment, admission source, 
timing, and functional impairment level; and the proportion of 30-day 
periods of care with and without any therapy visits, nursing visits, 
and/or aide/social worker visits. For the monitoring included in this 
rule, we examine simulated data for CYs 2018 and 2019 and actual data 
for CYs 2020, 2021, and 2022 for 30-day periods of care. We refer 
readers to the CY 2022 HH PPS final rule (86 FR 35881) for discussion 
about simulated data for CYs 2018 and 2019.
(a) Utilization
    Table B1 shows the overall utilization of home health services and 
Table B2 shows the average utilization of visits per 30-day period of 
care by home health discipline. This data indicates the average number 
of 30-day periods of care per unique HHA user is similar between CY 
2021 and CY 2022. The data also indicates that the number of 30-day 
periods of care decreased between CY 2018 and CY 2022. Table B3 shows 
the proportion of 30-day periods of care that are LUPAs and the average 
number of visits per discipline of those LUPA 30-day periods of care 
over time.
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[[Page 43664]]


[GRAPHIC] [TIFF OMITTED] TP10JY23.007

(b) Analysis of 2021 Cost Report Data for 30-Day Periods of Care
    In the CY 2023 HH PPS proposed rule (87 FR 37607), we provided a 
summary of analysis on FY 2020 HHA Medicare cost report data, as this 
was the most recent and complete cost report data at the time of 
rulemaking, and CY 2021 home health claims to estimate 30-day period of 
care costs. Our analysis showed that the CY 2021 national, standardized 
30-day period payment rate of $1,901.12 was approximately 34 percent 
more than the estimated CY 2021 estimated 30-day period cost of 
$1,420.35. In MedPAC's March 2023 Report to Congress,\1\ their review 
of home health payment adequacy found that ``access is more than 
adequate in most areas and that Medicare payments are substantially in 
excess of costs''.
---------------------------------------------------------------------------

    \1\ Report to Congress, Medicare Payment Policy. Home Health 
Care Services, Chapter 8. MedPAC. March 2023 https://www.medpac.gov/wp-content/uploads/2023/03/Ch8_Mar23_MedPAC_Report_To_Congress_SEC.pdf.
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    Using this same process in this proposed rule to compare home 
health payment to costs, we examined 2021 HHA Medicare cost reports 
(CMS Form 1728-20, OMB No. 0938-0222), as this is the most recent and 
complete cost report data at the time of rulemaking, and CY 2022 home 
health claims, to estimate 30-day period of care costs. We excluded 
LUPAs and partial payment adjustments in the average number of visits. 
The 2021 average NRS costs per visit is $6.71. To update the estimated 
30-day period of care costs, we begin with the 2021 average costs per 
visit with NRS for each discipline and multiply that amount by the CY 
2022 home health payment update percentage of 2.6 percent. That amount 
for each discipline is then multiplied by the 2022 average number of 
visits by discipline to determine the 2022 estimated 30-day period 
costs. Table B4 shows the estimated average costs for 30-day periods of 
care by discipline with NRS and the total 30-day period of care costs 
with NRS for CY 2022.
[GRAPHIC] [TIFF OMITTED] TP10JY23.008


[[Page 43665]]


    The CY 2022 national, standardized 30-day period payment rate was 
$2,031.64, which is approximately 45 percent more than the estimated CY 
2022 estimated 30-day period cost of $1,402.27. Note that in the CY 
2023 HH PPS proposed rule (87 FR 37608), the average number of visits 
for non-LUPA, non- partial payment adjustments 30-day periods of care 
in 2021 was 8.81 visits. Using actual CY 2022 claims data, the average 
number of visits for a non-LUPA, non-partial payment adjustments 30-day 
periods of care was 8.6 visits--a decrease of approximately 2.4 
percent. Note that in the CY 2020 HH PPS final rule with comment period 
(84 FR 60484), the average number of visits for non-LUPA, non- partial 
payment adjustments 30-day periods of care in 2017 was estimated to be 
10.5 visits. Therefore, the average number of visits for non-LUPA, non- 
partial payment adjustments, 30-day periods of care in CY 2022 
represents a decrease of 18 percent from the average number of visits 
for non-LUPA, non- partial payment adjustments 30-day periods of care 
in CY 2017. In its March 2023 Report to Congress, MedPAC assumed a cost 
growth of 4.1 percent for CY 2023.\2\ Furthermore, MedPAC noted that 
for more than a decade, payments under the HH PPS have significantly 
exceeded HHAs' costs primarily due to two factors. First, agencies have 
reduced the average number of visits per period to reduce period costs. 
Second, cost growth in recent years has been lower than the annual home 
health payment update percentages. As shown in Table B4 in this 
proposed rule, HHAs have reduced visits under the PDGM in CY 2022.
---------------------------------------------------------------------------

    \2\ Report to Congress, Medicare Payment Policy. Home Health 
Care Services, Chapter 8. MedPAC. March 2023 https://www.medpac.gov/wp-content/uploads/2023/03/Ch8_Mar23_MedPAC_Report_To_Congress_SEC.pdf
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(c) Clinical Groupings and Comorbidities
    Each 30-day period of care is grouped into one of 12 clinical 
groups, which describe the primary reason for which a patient is 
receiving home health services under the Medicare home health benefit. 
The clinical grouping is based on the principal diagnosis reported on 
the home health claim. Table B5 shows the distribution of the 12 
clinical groups over time.
[GRAPHIC] [TIFF OMITTED] TP10JY23.009

    Thirty-day periods of care will receive a comorbidity adjustment 
category based on the presence of certain secondary diagnoses reported 
on home health claims. These diagnoses are based on a home health 
specific list of clinically and statistically significant secondary 
diagnosis subgroups with similar resource use. We refer readers to 
section II.B.4.c. of this proposed rule and the CY 2020 HH PPS final 
rule with comment period (84 FR 60493) for further information on the 
comorbidity adjustment categories. Home health 30-day periods of care 
can receive a low or a high comorbidity adjustment, or no comorbidity 
adjustment. Table B6 shows the distribution of 30-day periods of care 
by comorbidity adjustment category for all 30-day periods.

[[Page 43666]]

[GRAPHIC] [TIFF OMITTED] TP10JY23.010

(d) Admission Source and Timing
    Each 30-day period of care is classified into one of two admission 
source categories--community or institutional--depending on what 
healthcare setting was utilized in the 14 days prior to receiving home 
health care. Thirty-day periods of care for beneficiaries with any 
inpatient acute care hospitalizations, inpatient psychiatric facility 
(IPF) stays, skilled nursing facility (SNF) stays, inpatient 
rehabilitation facility (IRF) stays, or long-term care hospital (LTCH) 
stays within 14-days prior to a home health admission will be 
designated as institutional admissions. The institutional admission 
source category will also include patients that had an acute care 
hospital stay during a previous 30-day period of care and within 14 
days prior to the subsequent, contiguous 30-day period of care and for 
which the patient was not discharged from home health and readmitted.
    Thirty-day periods of care are classified as ``early'' or ``late'' 
depending on when they occur within a sequence of 30-day periods of 
care. The first 30-day period of care is classified as early and all 
subsequent 30-day periods of care in the sequence (second or later) are 
classified as late. A subsequent 30-day period of care would not be 
considered early unless there is a gap of more than 60 days between the 
end of one previous period of care and the start of another. 
Information regarding the timing of a 30-day period of care comes from 
Medicare home health claims data and not the OASIS assessment to 
determine if a 30-day period of care is ``early'' or ``late''. Table B7 
shows the distribution of 30-day periods of care by admission source 
and period timing.
[GRAPHIC] [TIFF OMITTED] TP10JY23.011

(e) Functional Impairment Level
    Each 30-day period of care is placed into one of three functional 
impairment levels (low, medium, or high) based on responses to certain 
OASIS functional items associated with grooming, bathing, dressing, 
ambulating, transferring, and risk for hospitalization. The specific 
OASIS items that are used for the functional impairment level are found 
in Table B7 in the CY 2020 HH PPS final rule with comment period (84 FR 
60490).\3\ Responses to these OASIS items are grouped together into 
response categories with similar resource use and each response 
category has associated points. A more detailed description as to how 
these response categories were

[[Page 43667]]

established can be found in the technical report, ``Overview of the 
Home Health Groupings Model'' posted on the HHA webpage.\4\ The sum of 
these points results in a functional impairment score used to group 30-
day periods of care into a functional impairment level with similar 
resource use. The scores associated with the functional impairment 
levels vary by clinical group to account for differences in resource 
utilization. A patient's functional impairment level will remain the 
same for the first and second 30-day periods of care unless there is a 
significant change in condition that warrants an ``other follow-up'' 
assessment prior to the second 30-day period of care. For each 30-day 
period of care, the Medicare claims processing system will look for 
occurrence code 50 on the claim to correspond to the M0090 date of the 
applicable assessment. Table B8 shows the distribution of 30-day 
periods by functional impairment level.
---------------------------------------------------------------------------

    \3\ CMS continues to use the M1800-1860 items to determine 
functional impairment level for case-mix purposes while we continue 
to analyze the relationship between the analogous GG items (required 
as standardized patient assessment data) and the M1800 items used 
for payment.
    \4\ https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HomeHealthPPS/HH-PDGM.
[GRAPHIC] [TIFF OMITTED] TP10JY23.012

(f) Therapy Visits
    Beginning in CY 2020, section 1895(b)(4)(B)(ii) of the Act 
eliminated the use of therapy thresholds in calculating payments for CY 
2020 and subsequent years. Prior to implementation of the PDGM, HHAs 
could receive an adjustment to payment based on the number of therapy 
visits provided during a 60-day episode of care. We examined the 
proportion of actual 30-day periods of care with and without therapy 
visits. To be covered as skilled therapy, the services must require the 
skills of a qualified therapist (that is, PT, OT, or SLP) or qualified 
therapist assistant and must be reasonable and necessary for the 
treatment of the patient's illness or injury.\5\ As shown in Table B2, 
we monitor the number of visits per 30-day period of care by each home 
health discipline. Any 30-day period of care can include both therapy 
and non-therapy visits. If any 30-day period of care consisted of only 
visits for PT, OT, or SLP, then this 30-day period of care is 
considered ``therapy only''. If any 30-day period of care consisted of 
only visits for skilled nursing, home health aide, or social worker, 
then this 30-day period of care is considered ``no therapy''. If any 
30-day period of care consisted of at least one therapy visit and one 
non-therapy, then this 30-day period of care is considered ``therapy + 
non-therapy''. Table B9 shows the proportion of 30-day periods of care 
with only therapy visits, at least one therapy visit and one non-
therapy visit, and no therapy visits. Figure B2 shows the proportion of 
30-day periods of care by the number of therapy visits (excluding zero) 
provided during 30-day periods of care.
---------------------------------------------------------------------------

    \5\ Medicare Benefit Policy Manual, Chapter 7 Home Health 
Services, Section 40.2 Skilled Therapy Services https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c07.pdf.
---------------------------------------------------------------------------

BILLING CODE 4120-01-P

[[Page 43668]]

[GRAPHIC] [TIFF OMITTED] TP10JY23.013

[GRAPHIC] [TIFF OMITTED] TP10JY23.014

    Both Table B9 and Figure B2, as previously discussed, indicate 
there have been changes in the distribution of both therapy and non-
therapy visits in CY 2022 compared to CY 2021. For example, the percent 
of 30-day periods with one through seven therapy visits during a 30-day 
period increased in CY 2022 compared to CY 2021. Comparing therapy 
utilization from before the PDGM (CYs 2018 and 2019) to after the 
implementation of the PDGM (CYs 2020-2022), we have also seen a decline 
in therapy visits across all clinical groups, as shown in Figure B3.

[[Page 43669]]

[GRAPHIC] [TIFF OMITTED] TP10JY23.015

    We also examined the proportion of 30-day periods of care with and 
without skilled nursing, social work, or home health aide visits. Table 
B10 shows the number of 30-day periods of care with only skilled 
nursing visits, at least one skilled nursing visit and one other visit 
type (therapy or non-therapy), and no skilled nursing visits. Table B11 
shows the number of 30-day periods of care with and without home health 
aide or social worker visits.

[[Page 43670]]

[GRAPHIC] [TIFF OMITTED] TP10JY23.016

    Finally, we looked at home health aide utilization during CYs 2018-
2022. Figure B4 shows the total and average of home health aide visits 
by 30-day periods of care.

[[Page 43671]]

[GRAPHIC] [TIFF OMITTED] TP10JY23.017

BILLING CODE 4120-01-C
    We will continue to monitor the provision of home health services, 
including any changes in the number and duration of home health visits, 
composition of the disciplines providing such services, and overall 
home health payments to determine if refinements to the case-mix 
adjustment methodology may be needed in the future.
2. Request for Information (RFI) for Access to Home Health Aide 
Services
    Medicare covers intermittent/part-time personal care services and 
assistance with activities of daily living (ADL) provided by home 
health aides if a Medicare beneficiary is certified as needing a 
skilled service \6\ (Sec.  409.45). All home health services, including 
aide services, are to be furnished in accordance with a physician-
established plan of care. For home health services to be covered, the 
individualized plan of care must specify the services necessary to meet 
the patient-specific needs identified in the comprehensive assessment. 
In addition, the plan of care must include the identification of the 
responsible discipline(s) and the frequency and duration of all visits 
as well as those items listed in Sec.  484.60(a) that establish the 
need for such services. As the population ages, the prevalence of 
chronic disease increases and the need for home-based dependent 
services is on the rise.\7\ For eligible beneficiaries, home health 
aides can provide a necessary adjunct to medical care in managing 
medical conditions; assisting with ADLs (help with tasks such as 
bathing, grooming, dressing and toileting allows beneficiaries, 
particularly those with physical disabilities or chronic health 
conditions, to maintain their independence); assisting with medication 
management and adherence (help with reminders for beneficiaries to take 
their medications as prescribed and monitoring for adverse reactions or 
side effects); taking vital signs (home health aides can take vital 
signs such as blood pressure and heart rate, and report changes to the 
beneficiary's health care provider); and supplementing socialization 
(instances of social interaction during prescribed visits can help to 
improve the mental health and well-being of beneficiaries).\8\
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    \6\ Intermittent skilled nursing care, physical therapy, speech 
language pathology, or a continuing need for occupational therapy.
    \7\ Maresova, P., Javanmardi, E., Barakovic, S. et al. 
Consequences of chronic diseases and other limitations associated 
with old age--a scoping review. BMC Public Health 19, 1431 
(2019).https://doi.org/10.1186/s12889-019-7762-5
    \8\ Russell D, Rosati RJ, Peng TR, Barr[oacute]n Y, Andreopoulos 
E. Continuity in the Provider of Home Health Aide Services and the 
Likelihood of Patient Improvement in Activities of Daily Living. 
Home Health Care Management & Practice. 2013;25(1):6-12. 
doi:10.1177/1084822312453046
---------------------------------------------------------------------------

    Anecdotally, CMS has heard that beneficiaries have had difficulty 
receiving home health aide visits under the Medicare home health 
benefit. Additionally, our monitoring has shown that home health aide 
visits have decreased, as exhibited in Table B2 and Figure B4. CMS 
wants to ensure that all Medicare beneficiaries receiving care under 
the home health benefit are afforded all covered services for which 
they qualify. Therefore, in an effort to better understand any 
challenges facing Medicare beneficiaries in accessing home health aide 
services, CMS solicits public comment on the following:

[[Page 43672]]

     Why is utilization of home health aides continuing to 
decline as shown in Table B2 and Figure B4 if the need for these 
services remains strong?
     To what extent are higher acuity individuals eligible for 
Medicare (for example, individuals with multiple co-morbidities or 
impairments of multiple activities of daily living) having more 
difficulty accessing home health care services, specifically home 
health aide services?
     What are notable barriers or obstacles that home health 
agencies experience relating to recruiting and retaining home health 
aides? What steps could home health agencies take to improve the 
recruitment and retention of home health aides?
     Are HHAs paying home health aides less than equivalent 
positions in other care settings (for example, are aides in the 
inpatient hospital setting or nursing home setting paid more than in 
home health)? What are the reasons for the disparity in hourly wages or 
total pay for equivalent services?
     In what ways could HHAs ensure that home health aides are 
consistently paid wages that are commensurate with the impact they have 
on patient care that they provide to Medicare beneficiaries?
     How effective is the coordination between Medicare and 
Medicaid to ensure adequate access to home health aide services? Please 
share insights on the level of utilization of Medicaid benefits by 
dually eligible beneficiaries for additional home health aide services 
that are not being provided by Medicare.
     Are physicians' plans of care less reliant on home health 
aide services in the past, or are HHAs less willing/able to provide 
these services? If so, what are the primary reasons for why such 
services are not provided?
     What are the consequences of beneficiary difficulty in 
accessing home health aide services?

C. Proposed Provisions for CY 2024 Payment Under the HH PPS

1. Proposed Behavior Assumption Adjustments Under the HH PPS
(a) Background
    As discussed in section II.A.1. of this rule, starting in CY 2020, 
the Secretary was statutorily required by Section 1895 (b)(2)(B) of the 
Act, to change the unit of payment under the HH PPS from a 60-day 
episode of care to a 30-day period of care. CMS was also required to 
make assumptions about behavior changes that could occur as a result of 
the implementation of the 30-day unit of payment and the case-mix 
adjustment factors that eliminated the use of therapy thresholds. In 
the CY 2019 HH PPS final rule with comment period (83 FR 56455), we 
finalized three behavior change assumptions which were also described 
in the CY 2022 and 2023 HH PPS rules (86 FR 35890, 87 FR 37614, and 87 
FR 66795 through 66796). In the CY 2020 HH PPS final rule with comment 
period (84 FR 60519), we included these behavior change assumptions in 
the calculation of the 30-day budget neutral payment amount for CY 
2020, finalizing a negative 4.36 percent behavior change assumption 
adjustment (``assumed behaviors''). We did not propose any changes for 
CYs 2021 and 2022 relating to the behavior assumptions finalized in the 
CY 2019 HH PPS final rule with comment period, or to the negative 4.36 
percent behavior change assumption adjustment, finalized in the CY 2020 
HH PPS final rule with comment period.
    In the CY 2023 HH PPS final rule (87 FR 66796), we stated, based on 
our annual monitoring at that time, the three assumed behavior changes 
did occur as a result of the implementation of the PDGM and that other 
behaviors, such as changes in the provision of therapy and changes in 
functional impairment levels also occurred. We also reminded readers 
that in the CY 2020 HH PPS final rule with comment period (84 FR 60513) 
we stated we interpret actual behavior changes to encompass both 
behavior changes that were previously outlined as assumed by CMS, and 
other behavior changes not identified at the time the budget-neutral 
30-day payment rate for CY 2020 was established. In the CY 2023 HH PPS 
final rule (87 FR 66796) we provided supporting evidence that indicated 
the number of therapy visits declined in CYs 2020 and 2021, as well as 
a slight decline in therapy visits beginning in CY 2019 after the 
finalization of the removal of therapy thresholds, but prior to 
implementation of the PDGM. In section II.B.1. of this rule, our 
analysis continues to show overall the actual 30-day periods are 
similar to the simulated 30-day periods and there continues to be a 
decline in therapy visits, indicating that HHAs changed their behavior 
to reduce therapy visits. Although the analysis demonstrates evidence 
of individual behavior changes (for example, in the volume of visits 
for LUPAs, therapy sessions, etc.), we use the entirety of the 
behaviors in order to calculate estimated aggregate expenditures. The 
law instructs us to ensure that estimated aggregate expenditures under 
the PDGM are equal to the estimated aggregate expenditures that 
otherwise would have been made under the prior system.
    Section 4142(a) of the CAA, 2023, required CMS to present, to the 
extent practicable, a description of the actual behavior changes 
occurring under the HH PPS from CYs 2020-2026. This subsection of the 
CAA, 2023, also required CMS to provide datasets underlying the 
simulated 60-day episodes, and discuss and provide time for 
stakeholders to provide input and ask questions on the payment rate 
development for CY 2023. CMS complied with these requirements by 
posting online both the supplemental LDS and descriptive files and the 
description of actual behavior changes that affected CY 2023 payment 
rate development. Additionally, on March 29, 2023, CMS conducted a 
webinar entitled Medicare Home Health Prospective Payment System (HH 
PPS) Calendar Year (CY) 2023 Behavior Change Recap, 60-Day Episode 
Construction Overview, and Payment Rate Development. The webinar was 
open to the public and discussed the actual behavior changes that 
occurred upon implementation of the PDGM, our approach used to 
construct simulated 60-day episodes using 30-day periods, payment rate 
development for CY 2023, and information on the supplemental data files 
containing information on the simulated 60-day episodes and actual 30-
day periods used in calculating the permanent adjustment to the payment 
rate. Materials from the webinar, including the presentation and the CY 
2023 descriptive statistics from the supplemental LDS files, containing 
information on the number of simulated 60-day episodes and actual 30-
day periods in CY 2021 that were used to construct the permanent 
adjustment to the payment rate, as well as information such as the 
number of episodes and periods by case-mix group, case-mix weights, and 
simulated payments, can be found on the Home Health Patient-Driven 
Groupings Model web page at https://www.cms.gov/medicare/medicare-fee-
for-service-payment/homehealthpps/hh-pdgm.
(b) Method To Annually Determine the Impact of Differences Between 
Assumed Behavior Changes and Actual Behavior Changes on Estimated 
Aggregate Expenditures
    In the CY 2023 HH PPS final rule (87 FR 66804), we finalized the 
methodology to evaluate the impact of the differences between assumed 
and actual behavior changes on estimated aggregate expenditures. For 
CYs 2020 through 2026, we will evaluate if the 30-day budget neutral 
payment rate and resulting aggregate expenditures are equal under the 
PDGM to what they

[[Page 43673]]

would have been under the 153-group case-mix system and 60-day unit of 
payment. An overview of the methodology is listed in this section, 
followed by detailed instructions on each step.

 Create simulated 60-day episodes from 30-day periods
 Price out the simulated 60-day episodes and determine 
aggregate expenditures
 Price out only the 30-day periods which were used to create 
the simulated 60-day episodes and determine aggregate expenditures
 Compare aggregate expenditures between the simulated 60-day 
episodes and actual 30-day periods
 Determine what the 30-day payment rate should have been to 
equal aggregate expenditures
(1) Create Simulated 60-Day Episodes From 30-Day Periods
    The first step in our methodology is to determine which PDGM 30-day 
periods of care could be grouped together to form simulated 60-day 
episodes of care. To facilitate grouping, we made some exclusions and 
assumptions as described later in this section prior to pricing out the 
simulated 60-day episodes of care. We note in the early months of CY 
2020, there were 60-day episodes which started in 2019 and ended in 
2020 and therefore, some of these exclusions and assumptions may be 
specific to the first year of the PDGM. We identify, through footnotes, 
if an exclusion or assumption is specific to CY 2020 only.
(a) Exclusions
     Claims where the claim occurrence code 50 date (OASIS 
assessment date) occurred on or after October 31 of that year. This 
exclusion was applied to ensure the simulated 60-day episodes contained 
both 30-day periods from the same year and would not overlap into the 
following year (for example, 2021, 2022, 2023). This is done because 
any 30-day periods with an OASIS assessment date in November or 
December might be part of a simulated 60-day episode that would 
continue into the following year and where payment would have been made 
based on the ``through'' date. For CYs 2021 through 2026, we also 
excluded claims with an OASIS assessment date before January 1 of that 
year.\9\ Again, this is to ensure a simulated 60-day episode (simulated 
from two 30-day periods) does not overlap years.
---------------------------------------------------------------------------

    \9\ There are no 30-day PDGM claims which started in CY 2019 and 
ended in CY 2020, and therefore this exclusion would not apply to 
the CY 2020 dataset.
---------------------------------------------------------------------------

     Beneficiaries and all of their claims if they have 
overlapping claims from the same provider (as identified by CCN).\10\
---------------------------------------------------------------------------

    \10\ Claims are dropped from the same provider that extend into 
the following calendar year to ensure episode timing is accurate for 
simulated 60-day episodes. All of a beneficiary's claims are 
dropped, rather then only a subset, so as not to create a conflict 
in assigning episode timing.
---------------------------------------------------------------------------

     Beneficiaries and all of their claims if three or more 
claims from the same provider are linked to the same occurrence code 50 
date.\11\
---------------------------------------------------------------------------

    \11\ This is done because if three or more claims link to the 
same OASIS it would not be clear which claims should be joined to 
simulate a 60-day episode.
---------------------------------------------------------------------------

(b) Assumptions
     If two 30-day periods of care from the same provider 
reference the same OASIS assessment date (using occurrence code 50), 
then we assume those two 30-day periods of care would have been billed 
as a 60-day episode of care under the 153-group system.
     If two 30 day-periods of care reference different OASIS 
assessment dates and each of those assessment dates is referenced by a 
single 30-day period of care, and those two 30-day periods of care 
occur together close in time (that is, the ``from''date of the later 
30-day period of care is between 0 to 14 days after the ``through''date 
of the earlier 30-day period of care), then we assume those two 30-day 
periods of care also would have been billed as a 60-day episode of care 
under the 153-group system.
     For all other 30-day periods of care, we assume that they 
would not be combined with another 30-day period of care and would have 
been billed as a single 30-day period.
(2) Price Out the Simulated 60-Day Episodes and Determine Aggregate 
Expenditures
    After application of the exclusions and assumptions described 
previously, we have the simulated 60-day episodes dataset for each 
year. We assign each simulated 60-day episode of care as a normal 
episode, PEP, LUPA, or outlier based on the payment parameters 
established in the CY 2020 HH PPS final rule with comment period (84 FR 
60478) for 60-day episodes of care. Next, using the October 2019 3M 
Home Health Grouper (v8219) \12\ we assign a HIPPS code to each 
simulated 60-day episode of care using the 153-group methodology. 
Finally, we price the simulated 60-day episodes of care using the 
payment parameters described in the CY 2020 final rule with comment 
period (84 FR 60537) for 60-day episodes of care.
---------------------------------------------------------------------------

    \12\ https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HomeHealthPPS/CaseMixGrouperSoftware.
---------------------------------------------------------------------------

    For CYs 2021 through 2026, we adjust the simulated 60-day base 
payment rate to align with current payments for the analysis year (that 
is, wage index budget neutrality factor and home health payment 
update). For example, to calculate the CY 2021 simulated 60-day episode 
base payment rate, we started with the final CY 2020 60-day base 
payment rate ($3,220.79) and multiplied by the final CY 2021 wage index 
budget neutrality factor (0.9999) and the CY 2021 home health payment 
update (1.020) to get an adjusted 60-day base payment rate ($3,284.88) 
for CY 2021. We used that adjusted 60-day base payment rate ($3,284.88) 
to price out the CY 2021 simulated 60-day claims. Once each claim is 
priced under the pre-PDGM HH PPS, that is each claim is adjusted from 
the base payment rate by case-mix, wage index, etc., we calculate the 
estimated aggregate expenditures for all simulated 60-day episodes in 
CY 2021. This method is then replicated to price out the simulated 60-
day episodes for each year of claims data through CY 2026.
(3) Price Out the 30-Day Periods and Determine Aggregate Expenditures
    Next, we calculated the PDGM aggregate expenditures for CY 2020 
using those specific 30-day periods that were used to create the 
simulated 60-day episodes. Therefore, both the actual PDGM expenditures 
and the simulated pre-PDGM aggregate expenditures are based on the 
exact same claims for the permanent adjustment calculation.
(4) Compare Aggregate Expenditures Between the Simulated 60-Day 
Episodes and Actual 30-Day Periods
    We determine if the total aggregate expenditures under the PDGM 
were higher or lower than under the 153-case mix group system in each 
year beginning with CY 2020 through CY 2026. If expenditures were 
higher under the PDGM (that is, we paid more than we would have if the 
153-group payment system was in place), then the actual base payment 
rate we implemented was too high. If the expenditures were lower under 
the PDGM (that is, we paid less than we would have if the 153-group 
payment system was in place), then the actual base payment rate we 
implemented was too low.

[[Page 43674]]

(5) Determine What the 30-Day Payment Rate Should Have Been
    Using an iterative process, we determine what the 30-day base 
payment rate should have been, in order to achieve the same estimated 
aggregate expenditures as obtained from the simulated 60-day episodes. 
This is our recalculated (``repriced'') base payment rate.
(c) Calculating Permanent and Temporary Payment Adjustments
    To offset prospectively for such increases or decreases in 
estimated aggregate expenditures as a result of the impact of 
differences between assumed behavior changes and actual behavior 
changes, in any given year, we calculate a permanent prospective 
adjustment by calculating the percent change between the actual 30-day 
base payment rate and the recalculated 30-day base payment rate. This 
percent change is converted into a behavior adjustment factor and 
applied in the annual rate update process.
    To offset retrospectively for such increases or decreases in 
estimated aggregate expenditures as a result of the impact of 
differences between assumed behavior changes and actual behavior 
changes in any given year, we calculate a temporary prospective 
adjustment by calculating the dollar amount difference between the 
estimated aggregate expenditures from all 30-day periods using the 
recalculated 30-day base payment rate, and the aggregate expenditures 
for all 30-day periods using the actual 30-day base payment rate for 
the same year. In other words, when determining the temporary 
retrospective dollar amount, we use the full dataset of actual 30-day 
periods using both the actual and recalculated 30-day base payment 
rates to ensure that the utilization and distribution of claims are the 
same. In accordance with section 1895(b)(3)(D)(iii) of the Act, the 
temporary adjustment is to be applied on a prospective basis and shall 
apply only with respect to the year for which such temporary increase 
or decrease is made. Therefore, after we determine the dollar amount to 
be reconciled in any given year, we calculate a temporary adjustment 
factor to be applied to the base payment rate for that year. The 
temporary adjustment factor is based on an estimated number of 30-day 
periods in the next year using historical data trends, and as 
applicable, we control for a permanent adjustment factor, case-mix 
weight recalibration neutrality factor, wage index budget neutrality 
factor, and the home health payment update. The temporary adjustment 
factor is applied last.
(d) CY 2020 Results
    This section discusses the final results CMS determined from CY 
2020 claims data that was previously published in the CY 2023 final 
rule (87 FR 66804 through 66805). CMS did not do any recalculations for 
CY 2020 data and this section simply reiterates what was done 
previously for informative purposes only. Using the methodology 
described previously, we simulated 60-day episodes using actual CY 2020 
30-day periods to determine what the CY 2020 permanent and temporary 
payment adjustments should be to offset for such increases or decreases 
in estimated aggregate expenditures. For CY 2020, we began with 
8,423,688 30-day periods and dropped 603,157 30-day periods that had a 
claim occurrence code 50 date after October 31, 2020. We also 
eliminated 79,328 30-day periods that didn't appear to group with 
another 30-day period to form a 60-day episode if the 30-day period had 
a ``from date'' before January 15, 2020 or a ``through date'' after 
November 30, 2020. This was done to ensure a 30-day period would not 
have been part of a 60-day episode that would have overlapped into CY 
2021. Applying the additional exclusions and assumptions as described 
previously, an additional 14,062 30-day periods were excluded from this 
analysis. Additionally, we excluded 66,469 simulated 60-day episodes of 
care where no OASIS information was available in the CCW VRDC or could 
not be grouped to a HIPPS due to a missing primary diagnosis or other 
reason. Our simulated 60-day episodes of care produced a distribution 
of two 30-day periods of care (70.6 percent) and single 30-day periods 
of care (29.4 percent). This distribution is similar to what we found 
when we simulated 30-day periods of care for implementation of the 
PDGM. After all exclusions and assumptions were applied, the final 
dataset included 7,618,061 actual 30-day periods of care and 4,463,549 
simulated 60-day episodes of care for CY 2020.
    Using the final dataset for CY 2020 (7,618,061 actual 30-day 
periods which made up the 4,463,549 simulated 60-day episodes) we 
determined the estimated aggregate expenditures under the pre-PDGM HH 
PPS were lower than the actual estimated aggregate expenditures under 
the PDGM HH PPS. This indicates that aggregate expenditures under the 
PDGM were higher than if the 153-group payment system was still in 
place in CY 2020. As described previously in the methodology, we needed 
to calculate what the actual CY 2020 30-day base payment rate 
($1,864.03) should have been to equal the aggregate expenditures that 
we calculated using the simulated CY 2020 60-day episodes. We 
determined the CY 2020 30-day base payment rate should have been 
$1,742.52 based on actual behavior rather than the $1,864.03 based on 
assumed behaviors. The percent change between the two payment rates 
(actual and recalculated) would be the permanent adjustment. Next, we 
calculated the difference in aggregate expenditures for all CY 2020 
PDGM 30-day claims using the actual and recalculated payment rates. 
This difference is the retrospective dollar amount needed to offset 
payment. Our results are shown in Table B12.

[[Page 43675]]

[GRAPHIC] [TIFF OMITTED] TP10JY23.018

    As shown in Table B12 and in the CY 2023 HH PPS final rule (87 FR 
66805), a permanent prospective adjustment of -6.52 percent to the CY 
2023 30-day payment rate would be required to offset for such increases 
in estimated aggregate expenditures in future years. Additionally, we 
determined that our initial estimate of base payment rates required to 
achieve budget neutrality resulted in excess expenditures of HHAs of 
approximately $873 million in CY 2020. This would require a temporary 
adjustment to offset for such increase in estimated aggregate 
expenditures for CY 2020.
(e) CY 2021 Results
    This section discusses the final results CMS determined from CY 
2021 claims data that was previously published in the CY 2023 final 
rule (87 FR 66805 through 66806). CMS did not do any recalculations for 
CY 2021 data and this section simply reiterates what was done 
previously for informative purposes only. Using the methodology 
described previously, we simulated 60-day episodes using actual CY 2021 
30-day periods to determine what the permanent and temporary payment 
adjustments should be to offset for such increases or decreases in 
estimated aggregate expenditures as a result of the impact of 
differences between assumed behavior changes and actual behavior 
changes. For CY 2021, we began with 9,269,971 30-day periods of care 
and dropped 570,882 30-day periods of care that had claim occurrence 
code 50 date after October 31, 2021. We also excluded 968,434 30-day 
periods of care that had claim occurrence code 50 date before January 
1, 2021 to ensure the 30-day period would not be part of a simulated 
60-day episode that began in CY 2020. Applying the additional 
exclusions and assumptions as described previously, an additional 5,868 
30-day periods were excluded.
    Additionally, we excluded 14,302 simulated 60-day episodes of care 
where no OASIS information was available in the CCW VRDC or could not 
be grouped to a HIPPS due to a missing primary diagnosis or other 
reason. Our simulated 60-day episodes of care produced a distribution 
of two 30-day periods of care (70.0 percent) and single 30-day periods 
of care (30.0 percent) that was similar to what we found when we 
simulated two 30-day periods of care for implementation of the PDGM. 
After all exclusions and assumptions were applied, the final dataset 
included 7,703,261 actual 30-day periods of care and 4,529,498 
simulated 60-day episodes of care for CY 2021.
    Using the final dataset for CY 2021 (7,703,261 actual 30-day 
periods which made up the 4,529,498 simulated 60-day episodes) we 
determined the estimated aggregate expenditures under the pre-PDGM HH 
PPS were lower than the actual estimated aggregate expenditures under 
the PDGM HH PPS. This indicates that aggregate expenditures under the 
PDGM were higher than if the 153-group payment system was still in 
place in CY 2021. As described previously in the methodology, we needed 
to calculate what the actual CY 2021 30-day base payment rate 
($1,901.12) should have been to equal aggregate expenditures that we 
calculated using the simulated CY 2021 60-day episodes. We determined 
the CY 2021 30-day base payment rate should have been $1,751.90 based 
on actual behavior rather than the $1,901.12 based on assumed 
behaviors. The actual CY 2021 base payment rate of $1,901.12 does not 
account for any behavior adjustments needed for CY 2020, and therefore 
to evaluate changes for only CY 2021 we would need to control for the -
6.52 percent prospective adjustment that we determined for CY 2020. 
Therefore, using the recalculated CY 2020 base payment rate of 
$1,742.52, multiplied by the CY 2021 wage index budget neutrality 
factor (0.9999) and the CY 2021 home health payment update (1.020), the 
CY 2021 base payment rate for assumed behaviors would have been 
$1,777.19. The percent change between the two payment rates would be 
the annual permanent adjustment for CY 2021 (assuming the -6.52 percent 
adjustment was already taken). Next, we calculated the difference in 
aggregate expenditures for all CY 2021 PDGM 30-day claims using the 
actual ($1,901.12, as this was what CMS actually paid in CY 2021) and 
recalculated ($1,751.90) payment rates. This difference is the 
retrospective dollar amount needed to offset payment. Our results are 
shown in Table B13.

[[Page 43676]]

[GRAPHIC] [TIFF OMITTED] TP10JY23.019

    As shown in Table B13 and in the CY 2023 HH PPS final rule (87 FR 
66806), a permanent prospective adjustment of -1.42 percent (assuming 
the -6.52 percent adjustment was already taken) would be required to 
offset for such increases in estimated aggregate expenditures in future 
years. Additionally, we determined that our initial estimate of base 
payment rates required to achieve budget neutrality resulted in excess 
expenditures of approximately $1.2 billion in CY 2021. This would 
require a one-time temporary adjustment factor to offset for such 
increases in estimated aggregate expenditures for CY 2021.
(f) CY 2022 Preliminary Results
    We will continue the practice of using the most recent complete 
home health claims data at the time of rulemaking. The HH PPS limited 
data set (LDS) file released with this proposed rule includes two 
files: the actual CY 2022 30-day periods and the CY 2022 simulated 60-
day episodes. We remind readers a data use agreement (DUA) is required 
to purchase the CY 2024 proposed HH PPS LDS file. Access will be 
granted for both the 30-day periods and the simulated 60-day episodes 
under one DUA. Visit the HH PPS LDS web page for more information.\13\ 
In addition, the proposed CY 2024 Home Health Descriptive Statistics 
from the LDS Files spreadsheet is available on the Home Health 
Prospective Payment System Regulations and Notices web page,\14\ does 
not require a DUA, and is available at no cost to interested parties. 
The spreadsheet contains information on the number of simulated 60-day 
episodes and actual 30-day periods in CY 2022 that were used to 
determine the behavior adjustments. The spreadsheet also provides 
information such as the number of episodes and periods by case-mix 
group, case-mix weights, and simulated payments. The CY 2022 analysis 
presented in this proposed rule is considered preliminary and, as more 
data become available from the latter half of CY 2022, we will update 
our results in the final rule. The CY 2024 final rule will utilize the 
CY 2022 finalized data for determining any behavior adjustment needed 
to the CY 2024 payment rate. However, while the claims data and the 
permanent and temporary behavior adjustment results will be considered 
complete, any adjustments to future payment rates may be subject to 
additional considerations such as permanent adjustments taken in 
previous years.
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    \13\ https://www.cms.gov/research-statistics-data-and-systems/files-for-order/limiteddatasets/home_health_pps_lds.
    \14\ https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HomeHealthPPS/Home-Health-Prospective-Payment-System-Regulations-and-Notices.
---------------------------------------------------------------------------

    Using the methodology described previously, we simulated 60-day 
episodes using actual CY 2022 30-day periods to determine what the 
permanent and temporary payment adjustments should be to offset for 
such increases or decreases in estimated aggregate expenditures as a 
result of the impact of differences between assumed behavior changes 
and actual behavior changes. For CY 2022, we began with 8,386,706 30-
day periods of care and dropped 476,889 30-day periods of care that had 
claim occurrence code 50 date after October 31, 2022. We also excluded 
894,319 30-day periods of care that had claim occurrence code 50 date 
before January 1, 2022 to ensure the 30-day period would not be part of 
a simulated 60-day episode that began in CY 2021. Applying the 
additional exclusions and assumptions as described previously, an 
additional 5,452 30-day periods were excluded.
    Additionally, we excluded 17,054 simulated 60-day episodes of care 
where no OASIS information was available in the CCW VRDC or could not 
be grouped to a HIPPS due to a missing primary diagnosis or other 
reason. Our simulated 60-day episodes of care produced a distribution 
of two 30-day periods of care (69.1 percent) and single 30-day periods 
of care (30.9 percent) that was similar to what we found when we 
simulated two 30-day periods of care for implementation of the PDGM. 
After all exclusions and assumptions were applied, the final dataset 
for this proposed rule included 6,982,837 actual 30-day periods of care 
and 4,127,754 simulated 60-day episodes of care for CY 2022.
    Using the final dataset for CY 2022 (6,982,837 actual 30-day 
periods which made up the 4,127,754 simulated 60-day episodes) we 
determined the estimated aggregate expenditures under the pre-PDGM HH 
PPS were lower than the actual estimated aggregate expenditures under 
the PDGM HH PPS as shown in Table B14. This indicates that aggregate 
expenditures under the PDGM were higher than if the 153-group payment 
system was still in place in CY 2022. As described previously in the 
methodology, we needed to calculate

[[Page 43677]]

what the actual CY 2022 30-day base payment rate ($2,031.64) should 
have been to equal aggregate expenditures that we calculated using the 
simulated CY 2022 60-day episodes. We determined the CY 2022 30-day 
base payment rate should have been $1,841.55 based on actual behavior 
rather than the $2,031.64 based on assumed behaviors. We note, the 
actual CY 2022 base payment rate of $2,031.64 does not account for any 
behavior adjustments needed for CYs 2020 and 2021, and therefore to 
evaluate changes for only CY 2022 we need to account for the -7.85 
percent prospective adjustment that we determined for CYs 2020 and 
2021. Therefore, using the recalculated CY 2021 base payment rate of 
$1,751.90 (shown in Table B13), multiplied by the CY 2022 case-mix 
weights recalibration neutrality factor (1.0396), the CY 2022 wage 
index budget neutrality factor (1.0019) and the CY 2022 home health 
payment update (1.026), the CY 2022 base payment rate for assumed 
behavior would have been $1,872.18. The percent change between the two 
payment rates would be the additional permanent adjustment (assuming 
the -7.85 percent adjustment was already taken). Next, we calculated 
the difference in aggregate expenditures for all CY 2022 PDGM 30-day 
claims using the actual ($2,031.64) and recalculated ($1,841.55) 
payment rates. This difference is the retrospective dollar amount 
needed to offset payment. Our results are shown in Table B14.
[GRAPHIC] [TIFF OMITTED] TP10JY23.020

    As shown in Table B14, a permanent prospective adjustment of -1.636 
percent to the CY 2024 30-day payment rate (assuming the -7.85 percent 
adjustment was already taken) would be required to offset for such 
increases in estimated aggregate expenditures in future years. 
Additionally, we determined that our initial estimate of base payment 
rates required to achieve budget neutrality resulted in excess 
expenditures of approximately $1.4 billion in CY 2022. This would 
require a one-time temporary adjustment factor to offset for such 
increases in estimated aggregate expenditures for CY 2022.
(g) Proposed CY 2024 Permanent Adjustment and Temporary Adjustment 
Calculations
    To offset the increase in estimated aggregate expenditures for CYs 
2020 and 2021 based on the impact of the differences between assumed 
and actual behavior changes, CMS needed to apply a -7.85 percent 
permanent adjustment to the CY 2023 base payment rate, as well as 
implement a temporary adjustment of approximately $2.1 billion to 
reconcile retrospective overpayments in CYs 2020 and 2021. We 
recognized that applying the full permanent and temporary adjustment 
immediately would result in a significant negative adjustment in a 
single year. However, if the PDGM 30-day base payment rate remains 
higher than it should be, then there would likely be a compounding 
effect, potentially creating the need for an even larger reduction to 
adjust for behavioral changes in future years. Therefore, we proposed 
to apply only the permanent adjustment to the CY 2023 base payment 
rate. We believed this could mitigate the need for a larger permanent 
adjustment and could reduce the amount of any additional temporary 
adjustments in future years.
    We also recognized the potential hardship to some providers of 
implementing the full -7.85 percent permanent adjustment in a single 
year. As we have the discretion to implement any adjustment in a time 
and manner determined appropriate, in accordance with section 
1895(b)(3)(D) of the Act, we finalized only a -3.925 percent (half of 
the -7.85 percent) permanent adjustment for CY 2023. However, we 
emphasized that the permanent adjustment needed in CY 2023 to account 
fully for actual behavior changes in CYs 2020 and 2021 was -7.85 
percent, and applying a -3.925 percent permanent adjustment to the CY 
2023 30-day payment rate would not fully account for differences in 
behavior changes on estimated aggregate expenditures during those 
years, as well as CYs 2022 and 2023. We stated we would need to account 
for that difference in future rulemaking, and any additional 
adjustments needed to the base payment rate, to account for behavior 
change based on more recent data analysis.
    The percent change between the actual CY 2022 base payment rate of 
$2,031.64 (based on assumed behaviors) and the CY 2022 recalculated 
base payment rate of $1,841.55 (based on actual behaviors) (shown in 
Table B14) is the total (cumulative) permanent adjustment for CY 2022. 
The summation of the dollar amount for CYs 2020, 2021, and 2022 is the 
amount that represents the temporary payment adjustment to offset for 
increased aggregate expenditures in CYs 2020, 2021, and 2022. Our 
results are shown in Table B15 and B16.

[[Page 43678]]

[GRAPHIC] [TIFF OMITTED] TP10JY23.021

    We remind readers adjustment factors are multiplied in this payment 
system and therefore individual numbers (that is, percentages) do not 
sum precisely to the permanent adjustment needed to account for the 
total permanent adjustment in that year. Additionally, as we stated in 
the CY 2023 HH PPS final rule (87 FR 66808), applying a -3.925 percent 
permanent adjustment to the CY 2023 30-day payment rate would not 
adjust the rate fully to account for differences in behavior changes on 
estimated aggregate expenditures in CYs 2020 and 2021. Therefore, we 
cannot determine the CY 2024 proposed permanent adjustment by simply 
subtracting -3.925 percent from the total permanent adjustment of -
9.356 percent.
    Instead, we look at the total permanent adjustment needed for the 
current year of data and account for any prior permanent adjustments 
through multiplication and division of factors. In other words, we 
determined the total permanent adjustment based on CY 2022 data (which 
had no prior adjustments) is -9.356 percent, which is converted to a 
0.90644 factor. We recognize that in CY 2023 we implemented a -3.925 
percent permanent behavior adjustment, converted to a 0.96075 factor, 
and we must account for it in the proposed CY 2024 permanent 
adjustment. Next, we calculated the CY 2024 permanent adjustment factor 
by solving (1-x) = 0.90644 (9.356 percent) divided by 0.96075 (3.925 
percent). The resulting factor (1-x) is 0.94347, which is converted to 
a 5.653 percent reduction to the CY 2024 national, standardized base 
payment rate. In other words, 1 minus the factor 0.94347 equals 0.05653 
which is equal to 5.653 percent reduction. Therefore, to offset the 
increase in estimated aggregate expenditures for CY 2022 based on the 
impact of the differences between assumed and actual behavior changes, 
and to account for the permanent adjustment of -3.925 percent taken in 
CY 2023 rulemaking, CMS would need to apply a -5.653 percent permanent 
adjustment to the CY 2024 base payment rate. We are proposing to apply 
a -5.653 percent permanent adjustment to the CY 2024 national, 
standardized 30-day payment rate.
    We acknowledge that, as previously discussed, we finalized, in the 
CY 2023 HH PPS final rule, half of the -7.85 percent permanent 
adjustment, noting that the full permanent adjustment may be burdensome 
for some providers. However, we believe applying the full permanent 
adjustment of -5.635 in CY 2024 would potentially reduce any future 
permanent adjustments, stem the accrual of the temporary payment 
adjustment dollar amount, and would help fulfill the statutory 
requirements at section 1895(b)(3)(D) of the Act to offset any 
increases or decreases on the impact of differences between assumed 
behavior and actual behavior changes on estimated aggregate 
expenditures. We previously explained when reducing the permanent 
adjustment in CY 2023 that we would need to implement a greater rate 
reduction in future years, therefore home health agencies have had some 
time to consider this proposed rate reduction.
    In order to calculate the temporary adjustment, we would add the CY 
2022 temporary adjustment dollar amount of $1,355,208,655 to the 
previously finalized CYs 2020 and 2021 dollar amounts for a total of 
$3,439,284,729. We stated in the CY 2023 HH PPS final rule (87 FR 
66804) and in this proposed rule, after we determine the dollar amount 
to be reconciled we will calculate a temporary adjustment factor to be 
applied to the base payment rate for that year. That is, the dollar 
amount will be converted to a factor. However, as we noted in the CY 
2023 HH PPS proposed rule (87 FR 37682), we recognize that implementing 
both the permanent and temporary adjustments may adversely affect HHAs. 
Given that the magnitude of both the temporary and permanent 
adjustments for CY 2024 rate setting may result in a significant 
reduction of the payment rate, we are not proposing to take the 
temporary adjustment in CY 2024. We will propose a temporary adjustment 
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national, standardized base payment rate when we propose this temporary 
payment adjustment in future rulemaking. As noted previously, we will 
update these permanent and temporary adjustments in the final rule to 
reflect more complete claims data for CY 2022. We solicit comments on 
the proposal to apply a -5.653 percent permanent adjustment to the CY 
2024 base payment rate.
2. Proposed CY 2024 PDGM LUPA Thresholds and PDGM Case-Mix Weights
(a) Proposed CY 2024 PDGM LUPA Thresholds
    Under the HH PPS, LUPAs are paid when a certain visit threshold for 
a payment group during a 30-day period of care is not met. In the CY 
2019 HH PPS final rule with comment period (83 FR 56492), we finalized 
that the LUPA thresholds would be set at the 10th percentile of visits 
or 2 visits, whichever is higher, for each payment group. This means 
the LUPA threshold for each 30-day period of care varies depending on 
the PDGM payment group to which it is assigned. If the LUPA threshold 
for the payment group is met under the PDGM, the 30-day period of care 
will be paid the full 30-day period case-mix adjusted payment amount 
(subject to any partial payment adjustment or outlier adjustments). If 
a 30-day period of care does not meet the PDGM LUPA visit threshold, 
then payment will be made using the CY 2024 per-visit payment amounts 
as described in section II.C.4.f.2 of this proposed rule. For example, 
if the LUPA visit threshold is four, and a 30-day period of care has 
four or more visits, it is paid the full 30-day period payment amount; 
if the period of care has three or less visits, payment is made using 
the per-visit payment amounts.
    In the CY 2019 HH PPS final rule with comment period (83 FR 56492), 
we finalized our policy that the LUPA thresholds for each PDGM payment 
group would be reevaluated every year based on the most current 
utilization data available at the time of rulemaking. However, as CY 
2020 was the first year of the new case-mix adjustment methodology, we 
stated in the CY 2021 HH PPS final rule (85 FR 70305, 70306) that we 
would maintain the LUPA thresholds that were finalized and shown in 
Table 17 of the CY 2020 HH PPS final rule with comment period (84 FR 
60522) for CY 2021 payment purposes. We stated that at that time, we 
did not have sufficient CY 2020 data to reevaluate the LUPA thresholds 
for CY 2021.
    In the CY 2022 HH PPS final rule with comment period (86 FR 62249), 
we finalized the proposal to recalibrate the PDGM case-mix weights, 
functional impairment levels, and comorbidity subgroups while 
maintaining the LUPA thresholds for CY 2022. We stated that because 
there are several factors that contribute to how the case-mix weight is 
set for a particular case-mix group (such as the number of visits, 
length of visits, types of disciplines providing visits, and non-
routine supplies) and the case-mix weight is derived by comparing the 
average resource use for the case-mix group relative to the average 
resource use across all groups, we believe the COVID-19 PHE would have 
impacted utilization within all case-mix groups similarly. Therefore, 
the impact of any reduction in resource use caused by the PHE on the 
calculation of the case-mix weight would be minimized since the impact 
would be accounted for both in the numerator and denominator of the 
formula used to calculate the case-mix weight. However, in contrast, 
the LUPA thresholds are based on the number of overall visits in a 
particular case-mix group (the threshold is the 10th percentile of 
visits or 2 visits, whichever is greater) instead of a relative value 
(like what is used to generate the case-mix weight) that would control 
for the impacts of the COVID-19 PHE. We noted that visit patterns and 
some of the decrease in overall visits in CY 2020 may not be 
representative of visit patterns in CY 2022. Therefore, to mitigate any 
potential future and significant short-term variability in the LUPA 
thresholds due to the COVID-19 PHE, we finalized the proposal to 
maintain the LUPA thresholds finalized and displayed in Table 17 in the 
CY 2020 HH PPS final rule with comment period (84 FR 60522) for CY 2022 
payment purposes.
    For CY 2023, we proposed to update the LUPA thresholds using CY 
2021 Medicare home health claims (as of March 21, 2022) linked to OASIS 
assessment data. After reviewing the CY 2022 home health claims 
utilization data we determined that visit patterns have stabilized. Our 
data analysis indicated that visits in 2022 were similar to visits in 
2020. We believed that CY 2021 data will be more indicative of visit 
patterns in CY 2023 rather than continuing to use the LUPA thresholds 
derived from the CY 2018 data pre-PDGM. Therefore, we finalized a 
policy to update the LUPA thresholds for CY 2023 using data from CY 
2021.
    For CY 2024, we are proposing to update the LUPA thresholds using 
CY 2022 home health claims utilization data (as of March 17, 2023), in 
accordance with our policy to annually recalibrate the case-mix weights 
and update the LUPA thresholds, functional impairment levels and 
comorbidity subgroups. The proposed LUPA thresholds for the CY 2024 
PDGM payment groups with the corresponding Health Insurance Prospective 
Payment System (HIPPS) codes and the case-mix weights are listed in 
Table B22 We solicit public comments on the proposed updates to the 
LUPA thresholds for CY 2024.
(b) CY 2024 Functional Impairment Levels
    Under the PDGM, the functional impairment level is determined by 
responses to certain OASIS items associated with activities of daily 
living and risk of hospitalization; that is, responses to OASIS items 
M1800-M1860 and M1033. A home health period of care receives points 
based on each of the responses associated with these functional OASIS 
items, which are then converted into a table of points corresponding to 
increased resource use. The sum of all of these points results in a 
functional score which is used to group home health periods into a 
functional level with similar resource use. That is, the higher the 
points, the higher the response is associated with increased resource 
use. The sum of all of these points results in a functional impairment 
score which is used to group home health periods into one of three 
functional impairment levels with similar resource use. The three 
functional impairment levels of low, medium, and high were designed so 
that approximately one-third of home health periods from each of the 
clinical groups fall within each level. This means home health periods 
in the low impairment level have responses for the functional OASIS 
items that are associated with the lowest resource use, on average. 
Home health periods in the high impairment level have responses for the 
functional OASIS items that are associated with the highest resource 
use on average.
    For CY 2024, we propose to use CY 2022 claims data to update the 
functional points and functional impairment levels by clinical group. 
The CY 2018 HH PPS proposed rule (82 FR 35320) and the technical report 
from December 2016, posted on the Home Health PPS Archive web page 
located at: https://www.cms.gov/medicare/home-health-pps/home-health-pps-archive, provides a more detailed explanation as to the 
construction of these functional impairment levels using the OASIS 
items. We are proposing to use this

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same methodology previously finalized to update the functional 
impairment levels for CY 2024. The updated OASIS functional points 
table and the table of functional impairment levels by clinical group 
for CY 2024 are listed in Tables B17 and B18, respectively. We solicit 
public comments on the updates to functional points and the functional 
impairment levels by clinical group.
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(c) CY 2024 Comorbidity Subgroups
    Thirty-day periods of care receive a comorbidity adjustment 
category based on the presence of certain secondary diagnoses reported 
on home health claims. These diagnoses are based on a home-health 
specific list of clinically and statistically significant secondary 
diagnosis subgroups with similar resource use, meaning the diagnoses 
have at least as high as the median resource use and are reported in 
more than 0.1 percent of 30-day periods of care. Home health 30-day 
periods of care can receive a comorbidity adjustment under the 
following circumstances:
     Low comorbidity adjustment: There is a reported secondary 
diagnosis on the home health-specific comorbidity subgroup list that is 
associated with higher resource use.
     High comorbidity adjustment: There are two or more 
secondary diagnoses on the home health-specific comorbidity subgroup 
interaction list that are associated with higher resource use when both 
are reported together compared to when they are reported separately. 
That is, the two diagnoses may interact with one another, resulting in 
higher resource use.
     No comorbidity adjustment: A 30-day period of care 
receives no comorbidity adjustment if no secondary diagnoses exist or 
do not meet the criteria for a low or high comorbidity adjustment.
    In the CY 2019 HH PPS final rule with comment period (83 FR 56406), 
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examine the relationship of reported comorbidities on resource 
utilization and make the appropriate payment refinements to help ensure 
that payment is in alignment with the actual costs of providing care. 
For CY 2024, we propose to use the same methodology used to establish 
the comorbidity subgroups to update the comorbidity subgroups using CY 
2022 home health data.
    For CY 2024, we propose to update the comorbidity subgroups to 
include 21 low comorbidity adjustment subgroups as identified in Table 
B19 and 101 high comorbidity adjustment interaction subgroups as 
identified in Table B20. The proposed CY 2024 low comorbidity 
adjustment subgroups and the high comorbidity adjustment interaction 
subgroups including those diagnoses within each of these comorbidity 
adjustments will also be posted on the HHA Center web page at https://www.cms.gov/Center/Provider-Type/Home-Health-Agency-HHA-Center.
    We invite comments on the proposed updates to the low comorbidity 
adjustment subgroups and the high comorbidity adjustment interactions 
for CY 2024.
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(d) CY 2024 PDGM Case-Mix Weights
    As finalized in the CY 2019 HH PPS final rule with comment period 
(83 FR 56502), the PDGM places patients into meaningful payment 
categories based on patient and other characteristics, such as timing, 
admission source, clinical grouping using the reported principal 
diagnosis, functional impairment level, and comorbid conditions. The 
PDGM case-mix methodology results in 432 unique case-mix groups called 
home health resource groups (HHRGs). We also finalized a policy in the 
CY 2019 HH PPS final rule with comment period (83 FR 56515) to 
recalibrate annually the PDGM case-mix weights using a fixed effects 
model with the most recent and complete utilization data available at 
the time of annual rulemaking. Annual recalibration of the PDGM case-
mix weights ensures that the case-mix weights reflect, as accurately as 
possible, current home health resource use and changes in utilization 
patterns. To generate the proposed recalibrated CY 2024 case-mix 
weights, we used CY 2022 home health claims data with linked OASIS data 
(as of March 17, 2023). These data are the most current and complete 
data available at this time. We believe that recalibrating the case-mix 
weights using data from CY 2022 would be reflective of PDGM utilization 
and patient resource use for CY 2024. The proposed recalibrated case-
mix weights will be updated based on more complete CY 2022 claims data 
for the final rule.
    The claims data provide visit-level data and data on whether non-
routine supplies (NRS) were provided during the period and the total 
charges of NRS. We determine the case-mix weight for each of the 432 
different PDGM payment groups by regressing resource use on a series of 
indicator variables for each of the categories using a fixed effects 
model as described in the following steps:
    Step 1: Estimate a regression model to assign a functional 
impairment level to each 30-day period. The regression model estimates 
the relationship between a 30-day period's resource use and the 
functional status and risk of hospitalization items included in the 
PDGM, which are obtained from certain OASIS items. We refer readers to 
Table B17 for further information on the OASIS items used for the 
functional impairment level under the PDGM. We measure resource use 
with the cost-per-minute + NRS approach that uses information from 2021 
home health cost reports. We use 2021 home health cost report data 
because it is the most complete cost report data available at the time 
of rulemaking. Other variables in the regression model include the 30-
day period's admission source, clinical group, and 30-day period 
timing. We also include home health agency level fixed effects in the 
regression model. After estimating the regression model using 30-day 
periods, we divide the coefficients that correspond to the functional 
status and risk of hospitalization items by 10 and round to the nearest 
whole number. Those rounded numbers are used to compute a functional 
score for each 30-day period by summing together the rounded numbers 
for the functional status and risk of hospitalization items that are 
applicable to each 30-day period. Next, each 30-day period is assigned 
to a functional impairment level (low, medium, or high) depending on 
the 30-day period's total functional score. Each clinical group has a 
separate set of functional thresholds used to assign 30-day periods 
into a low, medium or high functional impairment level. We set those 
thresholds so that we assign roughly a third of 30-day periods within 
each clinical group to each functional impairment level (low, medium, 
or high).
    Step 2: A second regression model estimates the relationship 
between a 30-day period's resource use and indicator variables for the 
presence of any of the comorbidities and comorbidity interactions that 
were originally examined for inclusion in the PDGM. Like the first 
regression model, this model also includes home health agency level 
fixed effects and includes control variables for each 30-day period's 
admission source, clinical group, timing, and functional impairment 
level. After we estimate the model, we assign comorbidities to the low 
comorbidity adjustment if any comorbidities have a coefficient that is 
statistically significant (p-value of 0.05 or less) and which have a 
coefficient that is larger than the 50th percentile of positive and 
statistically significant comorbidity coefficients. If two 
comorbidities in the model and their interaction term have coefficients 
that sum together to exceed $150 and the interaction term is 
statistically significant (p-value of 0.05 or less), we assign the two 
comorbidities together to the high comorbidity adjustment.
    Step 3: After Step 2, each 30-day period is assigned to a clinical 
group, admission source category, episode timing category, functional 
impairment level, and comorbidity adjustment category. For each 
combination of those variables (which represent the 432 different 
payment groups that comprise the PDGM), we then calculate the 10th 
percentile of visits across all 30-day periods within a particular 
payment group. If a 30-day period's number of visits is less than the 
10th percentile for their payment group, the 30-day period is 
classified as a Low Utilization Payment Adjustment (LUPA). If a payment 
group has a 10th percentile of visits that is less than two, we set the 
LUPA threshold for that payment group to be equal to two. That means if 
a 30-day period has one visit, it is classified as a LUPA and if it has 
two or more visits, it is not classified as a LUPA.
    Step 4: Take all non-LUPA 30-day periods and regress resource use 
on the 30-day period's clinical group, admission source category, 
episode timing category, functional impairment level, and comorbidity 
adjustment category. The regression includes fixed effects at the level 
of the home health agency. After we estimate the model, the model 
coefficients are used to predict each 30-day period's resource use. To 
create the case-mix weight for each 30-day period, the predicted 
resource use is divided by the overall resource use of the 30-day 
periods used to estimate the regression.
    The case-mix weight is then used to adjust the base payment rate to 
determine each 30-day period's payment. Table B21 shows the 
coefficients of the payment regression used to generate the weights, 
and the coefficients divided by average resource use.
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    The case-mix weights proposed for CY 2024 are listed in Table B22 
and will also be posted on the HHA Center web page \15\ upon display of 
this proposed rule.
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    \15\ HHA Center web page: https://www.cms.gov/Center/Provider-Type/Home-Health-Agency-HHA-Center.

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BILLING CODE 4120-01-C
    Changes to the PDGM case-mix weights are implemented in a budget 
neutral manner by multiplying the CY 2024 national standardized 30-day

[[Page 43703]]

period payment rate by a case-mix budget neutrality factor. Typically, 
the case-mix weight budget neutrality factor is also calculated using 
the most recent, complete home health claims data available. For CY 
2024, we will continue the practice of using the most recent complete 
home health claims data at the time of rulemaking, which is CY 2022 
data. The case-mix budget neutrality factor is calculated as the ratio 
of 30-day base payment rates such that total payments when the CY 2024 
PDGM case-mix weights (developed using CY 2022 home health claims data) 
are applied to CY 2022 utilization (claims) data are equal to total 
payments when CY 2023 PDGM case-mix weights (developed using CY 2021 
home health claims data) are applied to CY 2022 utilization data. This 
produces a case-mix budget neutrality factor for CY 2024 of 1.0121.
    We invite public comments on the CY 2024 proposed case-mix weights 
and proposed case-mix weight budget neutrality factor.
3. Proposal To Rebase and Revise the Home Health Market Basket and 
Revise the Labor-Related Share
(a) Background
    Section 1895(b)(3)(B) of the Act requires that the standard 
prospective payment amounts for CY 2024 be increased by a factor equal 
to the applicable home health market basket update for those HHAs that 
submit quality data as required by the Secretary. Effective for cost 
reporting periods beginning on or after July 1, 1980, we developed and 
adopted an HHA input price index (that is, the home health ``market 
basket''). Although ``market basket'' technically describes the mix of 
goods and services used to produce home health care, this term is also 
commonly used to denote the input price index derived from that market 
basket. Accordingly, the term ``home health market basket'' used in 
this document refers to the HHA input price index.
    The percentage change in the home health market basket reflects the 
average change in the price of goods and services purchased by HHAs in 
providing an efficient level of home health care services. We first 
used the home health market basket to adjust HHA cost limits by an 
amount that reflected the average increase in the prices of the goods 
and services used to furnish reasonable cost home health care. This 
approach linked the increase in the cost limits to the efficient 
utilization of resources. For a greater discussion on the home health 
market basket, see the notice with comment period published in the 
February 15, 1980 Federal Register (45 FR 10450, 10451), the notice 
with comment period published in the February 14, 1995 Federal Register 
(60 FR 8389, 8392), and the notice with comment period published in the 
July 1, 1996 Federal Register (61 FR 34344, 34347). Beginning with the 
FY 2002 HH PPS payments, we have used the growth in a home health 
market basket to update payments under the HH PPS.
    We have rebased and revised the home health market basket 
periodically through the years since FY 2002. We rebased the home 
health market basket effective with the FY 2005 update (69 FR 31251-
31255), with the CY 2008 update (72 FR 25435-25442), and with the CY 
2013 update (77 FR 67081). We last rebased and revised the home health 
market basket effective with the CY 2019 update (83 FR 56425 through 
56435) reflecting a 2016 base year. Beginning with CY 2024, we are 
proposing to rebase and revise the home health market basket to reflect 
a 2021 base year. In the following discussion, we provide an overview 
of the proposed home health market basket and describe the 
methodologies used to determine the proposed 2021-based home health 
market basket.
    The home health market basket is a fixed-weight, Laspeyres-type 
price index. A Laspeyres-type price index measures the change in price, 
over time, of the same mix of goods and services purchased in the base 
period. Any changes in the quantity or mix of goods and services (that 
is, intensity) purchased over time relative to the base period are not 
measured.
    The index itself is constructed in three steps. First, a base 
period is selected (for the proposed home health market basket, we are 
proposing to use 2021 as the base period) and total base period costs 
are estimated for a set of mutually exclusive and exhaustive cost 
categories. Each category is calculated as a proportion of total costs. 
These proportions are called cost weights. Second, each expenditure 
category is matched to an appropriate price or wage variable, referred 
to as a price proxy. In almost every instance, these price proxies are 
derived from publicly available statistical series that are published 
on a consistent schedule (preferably at least on a quarterly basis). 
Finally, the cost weight for each cost category is multiplied by the 
level of its respective price proxy. The sum of these products (that 
is, the cost weights multiplied by their price index levels) for all 
cost categories yields the composite index level of the market basket 
in a given period. Repeating this step for other periods produces a 
series of market basket levels over time. Dividing an index level for a 
given period by an index level for an earlier period produces a rate of 
growth in the input price index over that timeframe.
    As noted previously, the market basket is described as a fixed-
weight index because it represents the change in price over time of a 
constant mix (quantity and intensity) of goods and services needed to 
provide HHA services. The effects on total costs resulting from changes 
in the mix of goods and services purchased subsequent to the base 
period are not measured. For example, an HHA hiring more nurses after 
the base period to accommodate the needs of patients would increase the 
volume of goods and services purchased by the HHA, but would not be 
factored into the price change measured by a fixed-weight home health 
market basket. Only when the index is rebased would changes in the 
quantity and intensity be captured, with those changes being reflected 
in the cost weights. Therefore, we rebase the home health market basket 
periodically so that the cost weights reflect recent changes in the mix 
of goods and services that HHAs purchase to furnish inpatient care 
between base periods.
(b) Proposed Rebasing and Revising of the Home Health Market Basket
    We believe that it is technically appropriate to rebase the home 
health market basket periodically so that the cost category weights 
reflect changes in the mix of goods and services that HHAs purchase in 
furnishing home health care. For the CY 2024 HH PPS proposed rule, we 
propose to rebase and revise the home health market basket to reflect a 
2021 base year using 2021 Medicare cost report data for Medicare-
participating freestanding HHAs, the latest available and most complete 
data on the actual structure of HHA costs at the time of this 
rulemaking. In prior rulemaking, commenters have expressed concern that 
recent cost pressures and the impact of the COVID-19 PHE have impacted 
input price inflation in providing home health services. We are 
proposing to use 2021 as the base year because we believe that the 
Medicare cost reports for this year represent the most recent, complete 
set of Medicare cost report data available for developing the proposed 
home health market basket that captures recent cost trends. Given the 
potential impact of the COVID-19 PHE on the Medicare cost report data, 
we will continue to monitor these data going forward and any changes to 
the

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home health market basket will be proposed in future rulemaking.
    The terms ``rebasing'' and ``revising,'' while often used 
interchangeably, denote different activities. The term ``rebasing'' 
means moving the base year for the structure of costs of an input price 
index (that is, in this exercise, we are proposing to move the base 
year cost structure from 2016 to 2021) without making any other major 
changes to the methodology. The term ``revising'' means changing data 
sources, cost categories, and price proxies used in the input price 
index. For the CY 2024 HH PPS proposed rule, we propose to rebase and 
revise the home health market basket to reflect a 2021 base year.
(c) Derivation of the Proposed 2021-Based Home Health Market Basket 
Major Cost Weights
    The major cost weights for the proposed revised and rebased home 
health market basket are derived from the Medicare cost reports (CMS 
Form 1728-20, OMB No. 0938-0022) for freestanding HHAs whose cost 
reporting period began on or after October 1, 2020 and before October 
1, 2021. Of the 2021 Medicare cost reports for freestanding HHAs, 
approximately 84 percent of the reports had a begin date on January 1, 
2021, approximately 5 percent had a begin date on July 1, 2021, and 
approximately 3 percent had a begin date on October 1, 2020. The 
remaining 8 percent had a begin date within the specified range. Using 
this methodology allowed our sample to include HHAs with varying cost 
report years including, but not limited to, the Federal fiscal or 
calendar year.
    We propose to maintain our policy of using data from freestanding 
HHAs, which account for about 93 percent of HHAs (87 FR 66882), as our 
analysis has determined that they better reflect HHAs' actual cost 
structure. Cost data for hospital-based HHAs can be affected by the 
allocation of overhead costs over the entire institution.
    We are proposing to derive seven major cost categories (Wages and 
Salaries, Benefits, Transportation, Professional Liability Insurance 
(PLI), Fixed Capital, Movable Capital, and Medical Supplies) from the 
2021 HHA Medicare cost reports. The residual cost category, ``All 
Other'', reflects all remaining costs not captured in the seven major 
cost categories. These costs are based on those cost centers that are 
reimbursable under the HH PPS, specifically cost centers 16 through 25 
(Skilled Nursing Care--RN, Skilled Nursing Care--LPN, Physical Therapy, 
Physical Therapy Assistant, Occupational Therapy, Certified 
Occupational Therapy Assistant, Speech-Language Pathology, Medical 
Social Services, Home Health Aide, and Medical Supplies Charged to 
Patients). While the cost centers have changed in CMS Form 1728-20, 
these generally coincide with those cost centers from CMS Form 1728-94 
that were used to derive the 2016-based home health market basket (83 
FR 56425). The cost centers used from CMS Form 1728-94 were cost 
centers 6 through 12 (Skilled Nursing Care, Physical Therapy, 
Occupational Therapy, Speech Pathology, Medical Social Services, Home 
Health Aide, and Supplies). Total costs for the HH PPS reimbursable 
services reflect overhead allocation. We note that Medical Supplies was 
not considered to be a major cost category in the 2016-based home 
health market basket because it was not derived directly from Medicare 
cost report data, and was instead derived from the residual ``All 
Other'' category using Benchmark Input-Output (I-O) data published by 
the Bureau of Economic Analysis (BEA). Next, we provide details on the 
proposed calculations for the total Medicare allowable costs and each 
of the proposed seven major cost categories derived from the Medicare 
cost report data. Unless otherwise specified, proposed calculations are 
consistent with 2016 methodology.
(1) Total Medicare Allowable Costs
    We propose that total Medicare allowable costs for HHAs would be 
equal to the sum of total costs for the Medicare allowable cost centers 
as reported on Worksheet B, column 10, lines 16 through 25. We propose 
that these total Medicare allowable costs for the HHA will be the 
denominator for the cost weight calculations for the Wages and 
Salaries, Benefits, Transportation, Professional Liability Insurance, 
Fixed Capital, Movable Capital, and Medical Supplies cost weights. With 
this work complete, we then set about deriving cost levels for the 
seven major cost categories.
(2) Costs for the Seven Major Cost Categories Derived From the Medicare 
Cost Report Data
(a) Wages and Salaries
    We propose that wages and salaries costs reflect direct patient 
care wage and salary costs, overhead wage and salary costs (associated 
with the following overhead cost centers: Plant Operations and 
Maintenance, Transportation, Telecommunications Technology, 
Administrative and General, Nursing Administration, Medical Records, 
and Other General Service cost centers), and a portion of direct 
patient care contract labor costs. The estimation of the wage and 
salary costs is derived using a similar methodology to that which was 
implemented for the 2016-based home health market basket, with the 
primary difference being the specific cost report line items now 
available on the HHA cost report form.
(i) Direct Patient Care
    We are proposing to calculate direct patient care wages and 
salaries by summing costs from Worksheet A, column 1, lines 16 through 
25.
(ii) Overhead
    We are proposing to calculate overhead wages and salaries by 
summing costs from Worksheet B, columns 3 through 9, lines 16 through 
25 multiplied by the percentage of costs in the overhead cost centers 
that were reported as salaries. This ratio is calculated as the sum of 
costs on Worksheet A, column 1, lines 3 through 9, divided by the sum 
of costs on Worksheet A, columns 1 through 5, lines 3 through 9.
(iii) Wages and Salaries Portion of Direct Patient Care Contract Labor
    Contract labor costs allocated to wages and salaries costs reflect 
a portion of the direct patient care contract labor costs. 
Specifically, we are proposing to calculate direct patient care 
contract labor costs by first summing costs from Worksheet A, column 4, 
lines 16 through 25. These contract labor costs are then multiplied by 
each provider's ratio of direct patient care wages and salaries costs 
to total direct patient care wages and salaries and benefits costs. 
This ratio is calculated as the sum of costs on Worksheet A, column 1, 
lines 16 through 25, divided by the sum of costs on Worksheet A, 
columns 1 and 2, lines 16 through 25. Similarly, the 2016 method for 
deriving the wages and salaries costs multiplied the combined salaries 
and benefits (both Direct Patient Care (DPC) and non-DPC) and DPC 
contract labor, by the ratio of combined DPC and non-DPC salaries to 
total DPC and non-DPC salaries and benefits.
(b) Benefits
    Benefits costs reflect direct patient care benefit costs, overhead 
benefit costs (associated with the following overhead cost centers: 
Plant Operations and Maintenance, Transportation, Telecommunications 
Technology, Administrative and General, Nursing Administration, Medical 
Records, and Other General Service) and a portion of direct patient 
care contract labor costs. Similarly, the 2016 method for deriving

[[Page 43705]]

the benefits costs multiplied the combined salaries and benefits (both 
DPC and non-DPC) and DPC contract labor, by the ratio of combined DPC 
and non-DPC benefits to total DPC and non-DPC salaries and benefits.
(i) Direct Patient Care
    We are proposing to calculate the cost of the direct patient care 
benefit costs by summing costs from Worksheet A, column 2, lines 16 
through 25.
(ii) Overhead
    We are proposing to calculate overhead benefit costs by summing 
costs from Worksheet B, columns 3 through 9, lines 16 through 25 
multiplied by the percentage of costs in the overhead cost centers that 
were reported as benefits. This percentage is calculated as the sum of 
costs on Worksheet A, column 2, lines 3 through 9, divided by the sum 
of costs on Worksheet A, columns 1 through 5, lines 3 through 9.
(iii) Benefits Portion of Direct Patient Care Contract Labor
    Contract labor costs allocated to Benefits costs reflect a portion 
of the direct patient care contract labor costs. Specifically, we are 
proposing to first calculate direct patient care contract labor costs 
by summing costs from Worksheet A, column 4, lines 16 through 25. These 
contract labor costs are then multiplied by each provider's ratio of 
direct patient care benefits costs to total direct patient care wages 
and salaries and benefits costs. This ratio is calculated as the sum of 
costs on Worksheet A, column 2, lines 16 through 25, divided by the sum 
of costs on Worksheet A, columns 1 and 2, lines 16 through 25.
(c) Transportation
    Transportation costs reflect direct patient care costs as well as 
transportation costs associated with Capital Expenses, Plant Operations 
and Maintenance, and Administrative and General cost centers. 
Specifically, we are proposing to calculate transportation costs by 
summing costs from Worksheet A, column 3, lines 16 through 25; 
Worksheet A, column 3, lines 1 through 3; and costs on Worksheet B, 
column 4, lines 16 through 25 multiplied by a ratio that reflects the 
non-salary and benefits portion of these costs. Specifically, this 
ratio was calculated as 1 minus the sum of costs on Worksheet A, 
columns 1 and 2, line 4, divided by the sum of costs on Worksheet A, 
columns 1 through 5, line 4.
(d) Professional Liability Insurance
    Professional Liability Insurance reflects premiums, paid losses, 
and self-insurance costs. Specifically, we are proposing to calculate 
Professional Liability Insurance by summing costs from Worksheet S-2 
Part I, line 14, columns 1 through 3.
(e) Fixed Capital
    Fixed Capital-related costs reflect the portion of Medicare-
allowable costs reported in Capital Related Buildings and Fixtures 
(Worksheet A, column 5, line 1). We are proposing to calculate this 
Medicare allowable portion by first calculating a ratio for each 
provider that reflects fixed capital costs as a percentage of HHA 
reimbursable services. Specifically, this ratio was calculated as the 
sum of costs from Worksheet B, column 1, lines 16 through 25 divided by 
the sum of costs from Worksheet B, column 1, line 1 minus lines 3 
through 9. This percentage is then applied to the costs from Worksheet 
A, column 5, line 1.
(f) Movable Capital
    Movable Capital-related costs reflect the portion of Medicare-
allowable costs reported in Capital Related Movable Equipment 
(Worksheet A, column 5, line 2). We are proposing to calculate this 
Medicare allowable portion by first calculating a ratio for each 
provider that reflects movable capital costs as a percentage of HHA 
reimbursable services. Specifically, this ratio was calculated as the 
sum of costs from Worksheet B, column 2, lines 16 through 25 divided by 
the sum of costs from Worksheet B, column 2, line 2 minus lines 3 
through 9. This percentage is then applied to the costs from Worksheet 
A, column 5, line 2.
(g) Medical Supplies
    Medical Supplies costs reflect the cost of supplies furnished to 
individual patients and for which a separate charge is made, as well as 
minor medical and surgical supplies not expected to be specifically 
identified in the plan of treatment or for which a separate charge is 
not made. Specifically, we propose to calculate Medical Supplies as the 
sum of Worksheet A, column 5, line 25; and Worksheet B, column 6, line 
25 multiplied by a ratio that reflects the non-salary and benefits 
portion of these costs. Specifically, this ratio was calculated as 1 
minus the sum of costs on Worksheet A, columns 1 and 2, line 6, divided 
by the sum of costs on Worksheet A, columns 1 through 5, line 6. We 
note that in the 2016-based home health market basket, the Medical 
Supplies cost weight was derived from the ``All Other'' residual cost 
weight.
(3) Derivation of the Major Cost Weights
    After we derive costs for each of the seven major cost categories 
and total Medicare allowable costs for each provider using the Medicare 
cost report data, we propose to address data outliers using the 
following steps. First, for each of the seven major cost categories, we 
divide the costs in that category by total Medicare allowable costs 
calculated for the provider to obtain cost weights for the universe of 
HHA providers. We propose to trim the data to remove outliers (a 
standard statistical process) by: (1) requiring that major costs (such 
as wages and salaries costs) and total Medicare allowable costs be 
greater than zero and requiring that category costs are less than the 
total Medicare allowable costs; and (2) excluding the top and bottom 
five percent of the major cost weight (for example, wages and salaries 
costs as a percent of total Medicare allowable costs). We note that 
missing values are assumed to be zero consistent with the methodology 
for how missing values were treated in the 2016-based home health 
market basket. After these outliers have been excluded, we sum the 
costs for each category across all remaining providers. We then divide 
this by the sum of total Medicare allowable costs across all remaining 
providers to obtain a cost weight for the proposed 2021-based home 
health market basket for the given category.
    Finally, we propose to calculate the residual ``All Other'' cost 
weight that reflects all remaining costs that are not captured in the 
other categories listed by subtracting the major cost weight 
percentages (Wages and Salaries, Benefits, Transportation, Professional 
Liability Insurance, Fixed Capital, Movable Capital, and Medical 
Supplies) from 1. We note that non-direct patient care contract labor 
costs (such as contract labor costs reported in the Administrative and 
General cost center of the Medicare cost report) are captured in the 
``All Other'' residual cost weight and later disaggregated into more 
detail as described later in this section.
    Table B23 shows the major cost categories and their respective cost 
weights as derived from the Medicare cost reports for this proposed 
rule.

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[GRAPHIC] [TIFF OMITTED] TP10JY23.045

    The decrease in the proposed wages and salaries cost weight of 0.9 
percentage point and the decrease in the proposed benefits cost weight 
of 0.2 percentage point is primarily attributable to direct patient 
care contract labor costs as reported on the Medicare cost report data, 
as shown in Table B24. Our analysis of the Medicare cost report data 
shows that a decrease in the compensation cost weight from 2016 to 2021 
occurred, in aggregate, among for-profit, nonprofit, and government 
providers and among providers serving only rural beneficiaries, only 
urban beneficiaries, or both rural and urban beneficiaries.
[GRAPHIC] [TIFF OMITTED] TP10JY23.046

    Our analysis of the Medicare cost report data shows that decreased 
contract labor utilization has occurred over most occupational 
categories, including higher-paid specialties in particular, and that 
utilization of direct patient care contract labor has been trending 
downward since 2010. We also note that over the 2016 to 2021 time 
period, the average number of full-time equivalents per provider 
decreased considerably.
(4) Derivation of the Detailed Cost Weights
    We propose to divide the ``All Other'' residual cost weight 
estimated from the 2021 Medicare cost report data into more detailed 
cost categories. To divide this cost weight, we are proposing to use 
the 2012 Benchmark I-O ``Use Tables/Before Redefinitions/Purchaser 
Value'' for North American Industrial Classification System (NAICS) 
621600, Home Health Agencies, published by the BEA. These data are 
publicly available at http://www.bea.gov/industry/io_annual.htm. For 
the 2016-based home health market basket, we used the 2007 Benchmark I-
O data, the most recent data available at the time (83 FR 56427).
    The BEA Benchmark I-O data are generally scheduled for publication 
every five years with the most recent data available for 2012. The 2012 
Benchmark I-O data are derived from the 2012 Economic Census and are 
the building blocks for BEA's economic accounts. Therefore, they 
represent the most comprehensive and complete set of data on the 
economic processes or mechanisms by which output is produced and 
distributed.\16\ Besides Benchmark I-O estimates, BEA also produces 
Annual I-O estimates. While based on a similar methodology, the Annual 
I-O estimates reflect less comprehensive and less detailed data sources 
and are subject to revision when benchmark data become available. 
Instead of using the less detailed Annual I-O data, we are proposing to 
inflate the detailed 2012 Benchmark
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    \16\ http://www.bea.gov/papers/pdf/IOmanual_092906.pdf.

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[[Page 43707]]

I-O data forward to 2021 by applying the annual price changes from the 
respective price proxies to the appropriate market basket cost 
categories that are obtained from the 2012 Benchmark I-O data. We 
repeated this practice for each year. Then, we calculated the cost 
shares that each cost category represents of the 2012 I-O data inflated 
to 2021. These resulting 2021 cost shares were applied to the ``All 
Other'' residual cost weight to obtain the detailed cost weights for 
the proposed 2021-based home health market basket. For example, the 
cost for Utilities represents 11.0 percent of the sum of the ``All 
Other'' 2012 Benchmark I-O HHA costs inflated to 2021. Therefore, the 
Utilities cost weight represents 11.0 percent of the proposed 2021-
based home health market basket's ``All Other'' cost category (18.6 
percent), yielding a Utilities proposed cost weight of 2.0 percent in 
the proposed 2021-based home health market basket (0.110 x 18.6 percent 
= 2.0 percent). For the 2016-based home health market basket, we used 
the same methodology utilizing the 2007 Benchmark I-O data (aged to 
---------------------------------------------------------------------------
2016).

    Using this methodology, we propose to derive eight detailed cost 
categories from the proposed 2021-based home health market basket ``All 
Other'' residual cost weight (18.6 percent). These categories are: (1) 
Utilities; (2) Administrative Support; (3) Financial Services; (4) 
Rubber and Plastics; (5) Telephone; (6) Professional Fees; (7) Other 
Products; and (8) Other Services. We note that the proposed Utilities 
cost category is currently referred to as Operations & Maintenance in 
the 2016-based home health market basket; however, the methodology and 
data sources underlying this cost category remain the same.
    Table B25 compares the cost categories and weights for the proposed 
2021-based home health market basket compared to the 2016-based home 
health market basket. In cases where a cost category has been 
recategorized in the proposed 2021-based home health market basket, we 
have entered ``n/a'' to maintain correct totals as they appear in the 
CY 2019 HH PPS final rule with comment period (83 FR 56428).
BILLING CODE 4120-01-P
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BILLING CODE 4120-01-C
(d) Selection of Price Proxies
    After developing the cost weights for the proposed 2021-based home 
health market basket, we select the most appropriate wage and price 
proxies currently available to represent the rate of price change for 
each cost category. With the exception of the price index for 
Professional Liability Insurance costs, the proposed price proxies are 
based on Bureau of Labor Statistics (BLS) data and are grouped into one 
of the following BLS categories:
     Employment Cost Indexes. Employment Cost Indexes (ECIs) 
measure the rate of change in employment wage rates and employer costs 
for employee benefits per hour worked. These indexes are fixed-weight 
indexes and strictly measure the change in wage rates and employee 
benefits per hour. ECIs are superior to Average Hourly Earnings (AHE) 
as price proxies for input price indexes because they are not affected 
by shifts in occupation or industry mix, and because they measure pure 
price change and are available by both occupational group and by 
industry. The industry ECIs are based on the NAICS and the occupational 
ECIs are based on the Standard Occupational Classification System 
(SOC).
     Producer Price Indexes. Producer Price Indexes (PPIs) 
measure the average change over time in the selling prices received by 
domestic producers for their output. The prices included in the PPI are 
from the first commercial transaction for many products and some 
services (https://www.bls.gov/ppi/).
     Consumer Price Indexes. Consumer Price Indexes (CPIs) 
measure the average change over time in the prices paid by urban 
consumers for a market basket of consumer goods and services (https://www.bls.gov/cpi/). CPIs are only used when the purchases are similar to 
those of retail consumers rather than purchases at the producer level, 
or if no appropriate PPIs are available.
    We evaluate the price proxies using the criteria of reliability, 
timeliness, availability, and relevance:
     Reliability. Reliability indicates that the index is based 
on valid statistical methods and has low sampling variability. Widely 
accepted statistical methods ensure that the data were collected and 
aggregated in a way that can be replicated. Low sampling variability is 
desirable because it indicates that the sample reflects the typical 
members of the population. (Sampling variability is variation that 
occurs by chance because only a sample was surveyed rather than the 
entire population.)
     Timeliness. Timeliness implies that the proxy is published 
regularly, preferably at least once a quarter. The market baskets are 
updated quarterly, and therefore, it is important for the underlying 
price proxies to be up-to-date, reflecting the most recent data 
available. We believe that using proxies that are published regularly 
(at least quarterly, whenever possible) helps to ensure that we are 
using the most recent data available to update the market basket. We 
strive to use publications that are disseminated frequently, because we 
believe that this is an optimal way to stay abreast of the most current 
data available.
     Availability. Availability means that the proxy is 
publicly available. We prefer that our proxies are publicly available 
because this will help ensure that our market basket updates are as 
transparent to the public as possible. In addition, this enables the 
public to be able to obtain the price proxy data on a regular basis.
     Relevance. Relevance means that the proxy is applicable 
and representative of the cost category weight to which it is applied. 
The CPIs, PPIs, and ECIs that we have selected to propose in this 
regulation meet these criteria. Therefore, we believe that they 
continue to be the best measure of price changes for the cost 
categories to which they would be applied.
    The following is a detailed explanation of the price proxies we are 
proposing for each cost category weight.
(e) Proposed 2021-Based Home Health Market Basket Price Proxies
    As part of the revising and rebasing of the home health market 
basket, we are proposing to rebase and revise the home health blended 
Wages and Salaries index and the home health blended Benefits index. We 
propose to use these blended indexes as price proxies for the Wages and 
Salaries and the Benefits categories of the proposed 2021-based home 
health market basket, as we did in the 2016-based home health market 
basket. The following is a more detailed discussion.
(1) Wages and Salaries
    For measuring price growth in the 2021-based home health market 
basket, we are proposing to apply six price proxies to six occupational 
subcategories within the Wages and Salaries cost weight, which would 
reflect the 2021 occupational mix in HHAs. This is a similar approach 
that was used for the 2016-based market basket. We propose to use a 
blended wage proxy because there is not a published wage proxy specific 
to the home health industry.
    We are proposing to continue to use the National Industry-Specific 
Occupational Employment and Wage estimates for NAICS 621600, Home 
Health Care Services, published by the BLS Office of Occupational 
Employment and Wage Statistics (OEWS) as the data source for the cost 
shares of the home health blended wage and benefits proxy. We note that 
in the spring of 2021, the Occupational Employment Statistics (OES) 
program began using the name Occupational Employment and Wage 
Statistics (OEWS) to better reflect the range of data available from 
the program. Data released on or after March 31, 2021 reflect the new 
program name. This is the same data source that was used for the 2016-
based HHA blended wage and benefit proxies; however, we are proposing 
to use the May 2021 estimates in place of the May 2016 estimates. 
Detailed information on the methodology for the national industry-
specific occupational employment and wage estimates survey can be found 
at http://www.bls.gov/oes/current/oes_tec.htm.
    The six occupational subcategories (Health-Related Professional and 
Technical, Non-Health-Related Professional and Technical, Management, 
Administrative, Health and Social Assistance Service, and Other Service 
Occupations) for the Wages and Salaries cost weight were tabulated from 
the May 2021 OEWS data for NAICS 621600, Home Health Care Services. 
Table B26 compares the proposed 2021 occupational assignments to the 
2016 occupational assignments of the six CMS designated subcategories. 
Data that are unavailable in the OEWS occupational classification for 
2016 or 2021 are shown in Table B26 as ``n/a.''
BILLING CODE 4120-01-P

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    Total costs by occupation were calculated by taking the OEWS number 
of employees multiplied by the OEWS annual average salary for each 
subcategory, and then calculating the proportion of total wage costs 
that each subcategory represents of the total industry wage costs. The 
proportions listed in Table B27 represent the proposed 2021 wages and 
salaries blend weights, and the proposed ECIs for each occupational 
category within the Wages and Salaries price proxy blend. We note that 
the ECIs reflect the 2021 occupational mix of workers. We also note 
that 2018 updates to the Standard Occupational Classification (SOC) 
system included a reclassification of Personal Care Aides from SOC code 
39-9021 to 31-1122, which is reflected in the updated weights and 
represents the major reason for the higher weight for health care and 
social assistance services and lower weight for other service 
occupations.\17\
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    \17\ https://www.bls.gov/soc/2018/soc_2018_whats_new.pdf.
    [GRAPHIC] [TIFF OMITTED] TP10JY23.050
    
    A comparison of the yearly changes from CY 2021 to CY 2024 for the 
2016-based home health Wages and Salaries proxy blend and the proposed 
2021-based home health Wages and Salaries proxy blend is shown in Table 
B28. The annual increases in the wages and salaries proposed price 
proxy is 0.3 percentage point lower in 2021 and 2022 relative to the 
2016-based price proxy, and 0.1 to 0.2 percentage point higher in 2023 
and 2024. These differences are primarily driven by the aforementioned 
reclassification of Personal Care Aides, which caused a shift in the 
relative share from the Other Service Occupations to Health and Social 
Assistance Services as illustrated previously in Table B27.

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[GRAPHIC] [TIFF OMITTED] TP10JY23.051

(2) Benefits
    For measuring Benefits price growth in the proposed 2021-based home 
health market basket, we are proposing to apply applicable price 
proxies to the six occupational subcategories that are used for the 
proposed Wages and Salaries price proxy blend. The proposed six 
categories in Table B29 are the same as those in the 2016-based home 
health market basket and include the same occupational mix as listed in 
Table B27.
[GRAPHIC] [TIFF OMITTED] TP10JY23.052

    There is no available data source that exists for benefit costs by 
occupation for the home health industry. Thus, to construct weights for 
the home health benefits blend we calculated the ratio of benefits to 
wages and salaries for 2021 for the six ECI series we are proposing to 
use in the blended `wages and salaries' and `benefits' indexes. To 
derive the relevant benefits weight, we applied the benefit-to-wage 
ratios to the 2021 OEWS wage and salary weights for each of the six 
occupational subcategories, and normalized. For example, the 2021 ECI 
data shows a ratio of benefits to wages for the health-related 
professional & technical category of 1.010. We applied this ratio to 
the 2021 OEWS weight for wages and salaries for health-related 
professional & technical (9.7 percent) to get an unnormalized weight of 
30.0 (29.7 times 1.010), and then normalized those weights relative to 
the other five benefit occupational categories to obtain a final 
benefit weight for health-related professional & technical (30.1 
percent).
    A comparison of the yearly changes from CY 2021 to CY 2024 for the 
2016-based home health Benefits proxy blend and the proposed 2021-based 
home health Benefits proxy blend is shown in Table B30. With the 
exception of a 0.2 percentage point difference in 2022, the annual 
increases in the two price proxies are the same when rounded to one 
decimal place.

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[GRAPHIC] [TIFF OMITTED] TP10JY23.053

(3) Medical Supplies
    We are proposing to use a 75/25 blend of the PPI Commodity data for 
Surgical and Medical Instruments (BLS series code #WPU1562) and the PPI 
Commodity data for Personal Safety Equipment and Clothing (BLS series 
code #WPU1571), which would replace the current price proxy of the PPI 
for Medical, Surgical, and Personal Aid Devices (BLS series code 
#WPU156). The PPI Commodity data for Personal Safety Equipment and 
Clothing would reflect personal protective equipment (PPE) including 
but not limited to face shields and protective clothing. The 2012 
Benchmark I-O data does not provide specific costs for the two 
categories we are proposing to blend. In absence of such data, we have 
based the weights of this blend on the change in the medical supplies 
weight as reported in the Medicare cost reports in the years prior to 
and after the COVID-19 PHE. Specifically, analysis of Medicare cost 
report data found that the average weight for medical supplies for the 
2016-2019 period (stable around 1.5 percent) was about 75 percent of 
the weight observed for the 2020-2021 period (roughly 2.0 percent). 
Thus, we believe that it was likely that the increase in the cost 
weight was mainly attributable to costs such as those associated with 
personal safety equipment and clothing, and are basing the proposed 75/
25 blend on that analysis. We believe this change will more closely 
proxy the rate of change of the underlying costs, including increased 
utilization of personal protective equipment.
(4) Professional Liability Insurance
    We are proposing to use the CMS Physician Professional Liability 
Insurance price index to measure price growth of this cost category. To 
generate this index, we collect commercial insurance premiums for a 
fixed level of coverage while holding non-price factors constant (such 
as a change in the level of coverage). The same proxy was used for the 
2016-based home health market basket.
(5) Transportation
    We are proposing to use the CPI U.S. city average for 
Transportation (BLS series code #CUUR0000SAT) to measure price growth 
of this category. The same proxy was used for the 2016-based home 
health market basket.
(6) Administrative and Support
    We are proposing to use the ECI for Total compensation for Private 
industry workers in Office and administrative support (BLS series code 
#CIU2010000220000I) to measure price growth of this cost category. The 
same proxy was used for the 2016-based home health market basket.
(7) Financial Services
    We are proposing to use the ECI for Total compensation for Private 
industry workers in Financial activities (BLS series code 
#CIU201520A000000I) to measure price growth of this cost category. The 
same proxy was used for the 2016-based home health market basket.
(8) Rubber and Plastics
    We are proposing to use the PPI Commodity data for Rubber and 
plastic products (BLS series code #WPU07) to measure price growth of 
this cost category. The same proxy was used for the 2016-based home 
health market basket.
(9) Telephone
    We are proposing to use CPI U.S. city average for Telephone 
services (BLS series code #CUUR0000SEED) to measure price growth of 
this cost category. The same proxy was used for the 2016-based home 
health market basket.
(10) Professional Fees
    We are proposing to use the ECI for Total compensation for Private 
industry workers in Professional and related (BLS series code 
#CIS2010000120000I) to measure price growth of this category. The same 
proxy was used for the 2016-based home health market basket.
(11) Utilities
    We are proposing to use CPI-U U.S. city average for Fuel and 
utilities (BLS series code #CUUR0000SAH2) to measure price growth of 
this cost category. The same proxy was used for the 2016-based home 
health market basket.
(12) Other Products
    We are proposing to use the PPI Commodity data for Final demand-
Finished goods less foods and energy (BLS series code #WPUFD4131) to 
measure price growth of this category. The same proxy was used for the 
2016-based home health market basket.
(13) Other Services
    We are proposing to use the ECI for Total compensation for Private 
industry workers in Service occupations (BLS series code 
#CIU2010000300000I) to measure price growth of this category. The same 
proxy was used for the 2016-based home health market basket.
(14) Fixed Capital
    We are proposing to use the CPI U.S. city average for Owners' 
equivalent rent of residences (BLS series code #CUUS0000SEHC) to 
measure price growth of this cost category. The same proxy was used for 
the 2016-based home health market basket.
(15) Movable Capital
    We are proposing to use the PPI Commodity data for Machinery and 
equipment (BLS series code #WPU11) to measure price growth of this cost 
category. The same proxy was used for the 2016-based home health market 
basket.
(f) Summary of Price Proxies of the Proposed 2021-Based Home Health 
Market Basket
    Table B31 shows the price proxies for the proposed 2021-based home 
health market basket.

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    We invite public comment on our proposal to rebase and revise the 
home health market basket to reflect a 2021 base year.
4. Proposed CY 2024 Home Health Payment Rate Updates
(a) Proposed CY 2024 Home Health Market Basket Percentage Increase
    A comparison of the yearly percent changes from CY 2019 to CY 2026 
for the 2016-based home health market basket and the proposed 2021-
based home health market basket based on IHS Global Inc.'s (IGI's) 
first quarter 2023 forecast, with historical data through the fourth 
quarter of 2022, is shown in Table B32. IGI is a nationally recognized 
economic and financial forecasting firm with which CMS contracts to 
forecast the components of the market baskets. Based on IGI's first 
quarter 2023 forecast, the proposed CY 2024 home health market basket 
percentage increase is 3.0 percent based on the proposed 2021-based 
home health market basket. We propose that if more recent data 
subsequently become available (for example, a more recent estimate of 
the market basket), we would use such data, if appropriate, to 
determine the market basket percentage increase in the final rule.
[GRAPHIC] [TIFF OMITTED] TP10JY23.056

BILLING CODE 4120-01-C
    Table B32 shows that the forecasted percentage increase for CY 2024 
of the proposed 2021-based home health market basket is 3.0 percent; 
0.1 percentage point lower growth as estimated using the 2016-based 
home health market basket. The average historical estimates of the 
growth in the proposed 2021-based and 2016-based home health market 
baskets over CY 2019 through CY 2022 differ by an average of 0.1 
percentage point. As discussed previously, this is primarily driven by 
a reclassification of Personal Care Aides, which caused a shift in the 
relative weight of the Wages and Salaries and Benefits blended price 
proxies from Other Service Occupations to Health and Social Assistance 
Services, which over this period grew relatively slower. Forecasted 
updates from CY 2023 through CY 2026 are the same on average; however, 
there is year to year variation of 0.1 percentage point for 
any given year.
(b) Proposed CY 2024 Productivity Adjustment
    In the CY 2015 HH PPS final rule (79 FR 38384), we finalized our 
methodology for calculating and applying the multifactor productivity 
adjustment. As we explained in that rule, section 1895(b)(3)(B)(vi) of 
the Act, requires that, in CY 2015 (and in subsequent calendar years, 
except CY 2018 (under section 411(c) of the Medicare Access and CHIP 
Reauthorization Act of 2015 (MACRA) (Pub. L. 114-10, enacted April 16,

[[Page 43715]]

2015)), the market basket percentage under the HH PPS as described in 
section 1895(b)(3)(B) of the Act be annually adjusted by changes in 
economy-wide productivity. Section 1886(b)(3)(B)(xi)(II) of the Act 
defines the productivity adjustment to be equal to the 10-year moving 
average of change in annual economy-wide private nonfarm business 
multifactor productivity (as projected by the Secretary for the 10-year 
period ending with the applicable fiscal year, calendar year, cost 
reporting period, or other annual period). The BLS publishes the 
official measures of productivity for the United States economy. We 
note that previously the productivity measure referenced in section 
1886(b)(3)(B)(xi)(II) of the Act was published by BLS as private 
nonfarm business multifactor productivity. Beginning with the November 
18, 2021 release of productivity data, BLS replaced the term 
``multifactor productivity'' with ``total factor productivity'' (TFP). 
BLS noted that this is a change in terminology only and will not affect 
the data or methodology. As a result of the BLS name change, the 
productivity measure referenced in section 1886(b)(3)(B)(xi)(II) of the 
Act is now published by BLS as ``private nonfarm business total factor 
productivity''. We refer readers to https://www.bls.gov for the BLS 
historical published TFP data. A complete description of IGI's TFP 
projection methodology is available on the CMS website at https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/MedicareProgramRatesStats/MarketBasketResearch. Based on IGI's 
first quarter 2023 forecast, the proposed productivity adjustment (the 
10-year moving average of TFP for the period ending December 31, 2024) 
for CY 2024 is 0.3 percent. We also propose that if more recent data 
subsequently become available (for example, a more recent estimate of 
the productivity adjustment), we would use such data, if appropriate, 
to determine the productivity adjustment in the CY 2024 HH PPS final 
rule.
(c) Proposed CY 2024 Annual Update for HHAs
    In accordance with section 1895(b)(3)(B)(iii) of the Act, we 
propose to base the CY 2024 market basket percentage increase, which is 
used to determine the applicable percentage increase for HHA payments, 
on the most recent estimate of the proposed 2021-based home health 
market basket percentage increase. Based on IGI's first quarter 2023 
forecast with history through the fourth quarter of 2022, the projected 
increase of the proposed 2021-based home health market basket for CY 
2024 is 3.0 percent. We propose to then reduce this percentage increase 
by the current estimate of the productivity adjustment for CY 2024 of 
0.3 percentage point in accordance with section 1895(b)(3)(B)(vi) of 
the Act. Therefore, the proposed CY 2024 home health payment update 
percentage is 2.7 percent (3.0 percent market basket percentage 
increase, reduced by 0.3 percentage point productivity adjustment). 
Furthermore, we propose that if more recent data subsequently become 
available (for example, a more recent estimate of the market basket and 
productivity adjustment), we would use such data, if appropriate, to 
determine the CY 2024 market basket percentage increase and 
productivity adjustment in the final rule.
    Section 1895(b)(3)(B)(v) of the Act requires that the home health 
percentage update be decreased by 2 percentage points for those HHAs 
that do not submit quality data as required by the Secretary. For HHAs 
that do not submit the required quality data for CY 2024, the proposed 
home health payment update percentage is 0.7 percent (2.7 percent minus 
2 percentage points).
    We invite public comment on our proposals for the CY 2024 home 
health market basket percentage increase and productivity adjustment.
(d) Labor-Related Share
    Effective for CY 2024, we are proposing to update the labor-related 
share to reflect the proposed 2021-based home health market basket 
Compensation (Wages and Salaries plus Benefits, which include direct 
patient care contract labor costs) cost weight. The current labor-
related share is based on the Compensation cost weight of the 2016-
based home health market basket. Based on the proposed 2021-based home 
health market basket, the proposed labor-related share is 74.9 percent 
and the proposed non-labor-related share is 25.1 percent. The labor-
related share for the 2016-based home health market basket was 76.1 
percent and the non-labor-related share was 23.9 percent. As explained 
earlier, the decrease in the compensation cost weight of 1.2 percentage 
points is primarily attributable to a lower cost weight of direct 
patient care contract labor costs as reported in the Medicare cost 
report data. Table B33 details the components of the labor-related 
share for the 2016-based and proposed 2021-based home health market 
baskets.
[GRAPHIC] [TIFF OMITTED] TP10JY23.057

    The revised labor-related share will be implemented in a budget 
neutral manner through the use of labor-related share budget neutrality 
factor (as described in section II.C.4.f.(2) below) so that the 
aggregate payments do not increase or decrease due to changes in the 
labor-related share values. We invite public comments on the proposed 
labor-related share and the use of a labor-related share budget 
neutrality factor.
(e) Proposed CY 2024 Home Health Wage Index
    Sections 1895(b)(4)(A)(ii) and (b)(4)(C) of the Act require the 
Secretary to provide appropriate adjustments to the proportion of the 
payment amount under the HH PPS that account for area

[[Page 43716]]

wage differences, using adjustment factors that reflect the relative 
level of wages and wage-related costs applicable to the furnishing of 
home health services. Since the inception of the HH PPS, we have used 
inpatient hospital wage data in developing a wage index to be applied 
to home health payments. We propose to continue this practice for CY 
2024, as it is our belief that, in the absence of home health-specific 
wage data that accounts for area differences, using inpatient hospital 
wage data is appropriate and reasonable for the HH PPS.
    In the CY 2021 HH PPS final rule (85 FR 70298), we finalized our 
proposal to adopt the revised OMB delineations with a 5-percent cap on 
wage index decreases, where the estimated reduction in a geographic 
area's wage index would be capped at 5-percent in CY 2021 only, meaning 
no cap would be applied to wage index decreases for the second year (CY 
2022). Therefore, we proposed and finalized the use of the FY 2022 pre-
floor, pre-reclassified hospital wage index with no 5-percent cap on 
decreases as the CY 2022 wage adjustment to the labor portion of the HH 
PPS rates (86 FR 62285). However, as described in the CY 2023 HH PPS 
final rule (87 FR 66851 through 66853), for CY 2023 and each subsequent 
year, we finalized that the CY HH PPS wage index would include a 5-
percent cap on wage index decreases. Specifically, we finalized for CY 
2023 and subsequent years, the application of a permanent 5-percent cap 
on any decrease to a geographic area's wage index from its wage index 
in the prior year, regardless of the circumstances causing the decline. 
That is, we finalized that a geographic area's wage index for CY 2023 
would not be less than 95 percent of its final wage index for CY 2022, 
regardless of whether the geographic area is part of an updated CBSA, 
and that for subsequent years, a geographic area's wage index would not 
be less than 95 percent of its wage index calculated in the prior CY. 
For CY 2024, we propose to base the HH PPS wage index on the FY 2024 
hospital pre-floor, pre-reclassified wage index for hospital cost 
reporting periods beginning on or after October 1, 2019 and before 
October 1, 2020 (FY 2020 cost report data). The proposed CY 2024 HH PPS 
wage index would not take into account any geographic reclassification 
of hospitals, including those in accordance with section 1886(d)(8)(B) 
or 1886(d)(10) of the Act but would include the 5-percent cap on wage 
index decreases. We will apply the appropriate wage index value to the 
revised labor portion of the HH PPS rates based on the site of service 
for the beneficiary (defined by section 1861(m) of the Act as the 
beneficiary's place of residence).
    To address those geographic areas in which there are no inpatient 
hospitals, and thus, no hospital wage data on which to base the 
calculation of the CY 2024 HH PPS wage index, we propose to continue to 
use the same methodology discussed in the CY 2007 HH PPS final rule (71 
FR 65884) to address those geographic areas in which there are no 
inpatient hospitals. For rural areas that do not have inpatient 
hospitals, we propose to use the average wage index from all contiguous 
Core Based Statistical Areas (CBSAs) as a reasonable proxy. Currently, 
the only rural area without a hospital from which hospital wage data 
could be derived is Puerto Rico. However, for rural Puerto Rico, we do 
not apply this methodology due to the distinct economic circumstances 
that exist there (for example, due to the close proximity to one 
another of almost all of Puerto Rico's various urban and non-urban 
areas, this methodology would produce a wage index for rural Puerto 
Rico that is higher than that in half of its urban areas). Instead, we 
propose to continue to use the most recent wage index previously 
available for that area. The most recent wage index previously 
available for rural Puerto Rico is 0.4047, which is what we propose to 
use. For urban areas without inpatient hospitals, we use the average 
wage index of all urban areas within the State as a reasonable proxy 
for the wage index for that CBSA. For CY 2024, the only urban area 
without inpatient hospital wage data is Hinesville, GA (CBSA 25980). 
Using the average wage index of all urban areas in Georgia as proxy, we 
propose the CY 2024 wage index value for Hinesville, GA to be 0.8601.
    On February 28, 2013, OMB issued Bulletin No. 13-01, announcing 
revisions to the delineations of MSAs, Micropolitan Statistical Areas, 
and CBSAs, and guidance on uses of the delineation of these areas. In 
the CY 2015 HH PPS final rule (79 FR 66085 through 66087), we adopted 
OMB's area delineations using a 1-year transition.
    On August 15, 2017, OMB issued Bulletin No. 17-01 in which it 
announced that one Micropolitan Statistical Area, Twin Falls, Idaho, 
now qualifies as a Metropolitan Statistical Area. The new CBSA (46300) 
comprises the principal city of Twin Falls, Idaho in Jerome County, 
Idaho and Twin Falls County, Idaho. The CY 2022 HH PPS wage index value 
for CBSA 46300, Twin Falls, Idaho, will be 0.8707. Bulletin No. 17-01 
is available at https://www.whitehouse.gov/wp-content/uploads/legacy_drupal_files/omb/bulletins/2017/b-17-01.pdf.
    On April 10, 2018 OMB issued OMB Bulletin No. 18-03, which 
superseded the August 15, 2017 OMB Bulletin No. 17-01. On September 14, 
2018, OMB issued OMB Bulletin No. 18-04 which superseded the April 10, 
2018 OMB Bulletin No. 18-03. These bulletins established revised 
delineations for Metropolitan Statistical Areas, Micropolitan 
Statistical Areas, and Combined Statistical Areas, and provided 
guidance on the use of the delineations of these statistical areas. A 
copy of OMB Bulletin No. 18-04 may be obtained at: https://www.bls.gov/bls/omb-bulletin-18-04-revised-delineations-of-metropolitan-statistical-areas.pdf.
    On March 6, 2020, OMB issued Bulletin No. 20-01, which provided 
updates to and superseded OMB Bulletin No. 18-04 that was issued on 
September 14, 2018. The attachments to OMB Bulletin No. 20-01 provided 
detailed information on the update to statistical areas since September 
14, 2018, and were based on the application of the 2010 Standards for 
Delineating Metropolitan and Micropolitan Statistical Areas to Census 
Bureau population estimates for July 1, 2017 and July 1, 2018. (For a 
copy of this bulletin, we refer readers to https://www.whitehouse.gov/wp-content/uploads/2020/03/Bulletin-20-01.pdf). In OMB Bulletin No. 20-
01, OMB announced one new Micropolitan Statistical Area, one new 
component of an existing Combined Statistical Area and changes to New 
England City and Town Area (NECTA) delineations. In the CY 2021 HH PPS 
final rule (85 FR 70298), we stated that if appropriate, we would 
propose any updates from OMB Bulletin No. 20-01 in future rulemaking. 
After reviewing OMB Bulletin No. 20-01, we have determined that the 
changes in Bulletin 20-01 encompassed delineation changes that would 
not affect the Medicare home health wage index for CY 2022. 
Specifically, the updates consisted of changes to NECTA delineations 
and the re-designation of a single rural county into a newly created 
Micropolitan Statistical Area. The Medicare home health wage index does 
not utilize NECTA definitions, and, as most recently discussed in the 
CY 2021 HH PPS final rule (85 FR 70298) we include hospitals located in 
Micropolitan Statistical areas in each State's rural wage index. In 
other words, these OMB updates did not affect any geographic areas for 
purposes of the HH PPS wage index calculation.

[[Page 43717]]

    The proposed CY 2024 wage index is available on the CMS website at: 
https://www.cms.gov/Center/Provider-Type/Home-Health-Agency-HHA-Center.
(f) Proposed CY 2024 Home Health Payment Update
(1) Background
    The HH PPS has been in effect since October 1, 2000. As set forth 
in the July 3, 2000 final rule (65 FR 41128), the base unit of payment 
under the HH PPS was a national, standardized 60-day episode payment 
rate. As finalized in the CY 2019 HH PPS final rule with comment period 
(83 FR 56406), and as described in the CY 2020 HH PPS final rule with 
comment period (84 FR 60478), the unit of home health payment changed 
from a 60-day episode to a 30-day period effective for those 30-day 
periods beginning on or after January 1, 2020.
    As set forth in Sec.  484.220, we adjust the national, standardized 
prospective payment rates by a case-mix relative weight and a wage 
index value based on the site of service for the beneficiary. To 
provide appropriate adjustments to the proportion of the payment amount 
under the HH PPS to account for area wage differences, we apply the 
appropriate wage index value to the labor portion of the HH PPS rates. 
In the CY 2019 HH PPS final rule with comment period (83 FR 56435), we 
finalized rebasing the home health market basket to reflect 2016 
Medicare cost report data. We also finalized a revision to the labor-
related share to reflect the 2016-based home health market basket 
Compensation (Wages and Salaries plus Benefits) cost weight. We 
finalized that for CY 2019 and subsequent years, the labor-related 
share would be 76.1 percent and the non-labor related share would be 
23.9 percent. As discussed earlier in section II.C.3, for CY 2024 we 
are proposing to rebase the home health market basket using 2021 
Medicare cost report data. We are also proposing that the labor-related 
share based on the proposed 2021-based home health market basket would 
be 74.9 percent and the non-labor-related share would be 25.1 percent. 
The following are the steps we take to compute the case-mix and wage-
adjusted 30-day period payment amount for CY 2024:
     Multiply the national, standardized 30-day period rate by 
the patient's applicable case-mix weight.
     Divide the case-mix adjusted amount into a labor (74.9 
percent) and a non-labor portion (25.1 percent).
     Multiply the labor portion by the applicable wage index 
based on the site of service of the beneficiary.
     Add the wage-adjusted portion to the non-labor portion, 
yielding the case-mix and wage adjusted 30-day period payment amount, 
subject to any additional applicable adjustments.
    We provide annual updates of the HH PPS rate in accordance with 
section 1895(b)(3)(B) of the Act. Section 484.225 sets forth the 
specific annual percentage update methodology. In accordance with 
section 1895(b)(3)(B)(v) of the Act and Sec.  484.225(i), for an HHA 
that does not submit home health quality data, as specified by the 
Secretary, the unadjusted national prospective 30-day period rate is 
equal to the rate for the previous calendar year increased by the 
applicable home health payment update percentage, minus 2 percentage 
points. Any reduction of the percentage change would apply only to the 
calendar year involved and would not be considered in computing the 
prospective payment amount for a subsequent calendar year.
    The final claim that the HHA submits for payment determines the 
total payment amount for the period and whether we make an applicable 
adjustment to the 30-day case-mix and wage-adjusted payment amount. The 
end date of the 30-day period, as reported on the claim, determines 
which calendar year rates Medicare will use to pay the claim.
    We may adjust a 30-day case-mix and wage-adjusted payment based on 
the information submitted on the claim to reflect the following:
     A LUPA is provided on a per-visit basis as set forth in 
Sec. Sec.  484.205(d)(1) and 484.230.
     A partial payment adjustment as set forth in Sec. Sec.  
484.205(d)(2) and 484.235.
     An outlier payment as set forth in Sec. Sec.  
484.205(d)(3) and 484.240.
(2) CY 2024 National, Standardized 30-Day Period Payment Amount
    Section 1895(b)(3)(A)(i) of the Act requires that the standard 
prospective payment rate and other applicable amounts be standardized 
in a manner that eliminates the effects of variations in relative case-
mix and area wage adjustments among different home health agencies in a 
budget-neutral manner. To determine the CY 2024 national, standardized 
30-day period payment rate, we will continue our practice of using the 
most recent, complete utilization data at the time of rulemaking; that 
is, we are using CY 2022 claims data for CY 2024 payment rate updates. 
We apply a permanent behavioral adjustment factor, a case-mix weights 
recalibration budget neutrality factor, a wage index budget neutrality 
factor, a labor-related share budget neutrality factor and the home 
health payment update percentage to update the CY 2024 payment rate. As 
discussed in section II.C.1 of this proposed rule, we are proposing to 
implement a permanent behavior adjustment of -5.653 percent to ensure 
that payments under the PDGM do not exceed what payments would have 
been under the 153-group payment system as required by law. The 
proposed permanent behavior adjustment factor is 0.94347. As discussed 
previously, to ensure the changes to the PDGM case-mix weights are 
implemented in a budget neutral manner, we apply a case-mix weight 
budget neutrality factor to the CY 2024 national, standardized 30-day 
period payment rate. The proposed case-mix weight budget neutrality 
factor for CY 2024 is 1.0121.
    Additionally, we apply a wage index budget neutrality factor to 
ensure that wage index updates and revisions are implemented in a 
budget neutral manner. To calculate the wage index budget neutrality 
factor, we first determine the payment rate needed for non-LUPA 30-day 
periods using the CY 2024 wage index so those total payments are 
equivalent to the total payments for non-LUPA 30-day periods using the 
CY 2023 wage index and the CY 2023 national standardized 30-day period 
payment rate adjusted by the case-mix weights recalibration neutrality 
factor. Then, by dividing the payment rate for non-LUPA 30-day periods 
using the CY 2024 wage index with a 5-percent cap on wage index 
decreases by the payment rate for non-LUPA 30-day periods using the CY 
2023 wage index with a 5-percent cap on wage index decreases, we obtain 
a wage index budget neutrality factor of 1.0015. We then apply the wage 
index budget neutrality factor of 1.0015 to the 30-day period payment 
rate. After we apply the wage index budget neutrality factor, we will 
also apply a labor-related share budget neutrality factor so that 
aggregate payments do not increase or decrease due to changes in the 
labor-related share values. In order to calculate the labor-related 
share budget neutrality factor, we simulate total payments using CY 
2022 home health utilization claims data with the CY 2024 HH PPS wage 
index and the proposed labor-related share (labor-related share of 74.9 
percent and non-labor-related share of 25.1 percent) and compare it to 
our simulation of total payments using the CY 2024 HH PPS wage index 
with the current labor-related share (labor-related share of 76.1 
percent and non-labor-related share of 23.9 percent). By dividing the 
base payment amount using the proposed labor-related share

[[Page 43718]]

and CY 2024 wage index and payment rate by the base payment amount 
using the current labor-related share and CY 2024 wage index and 
payment rate, we obtain a labor-related share budget neutrality factor 
of 0.9998.
    Next, we propose to update the 30-day period payment rate by the 
proposed CY 2024 home health payment update percentage of 2.7 percent. 
The CY 2024 national, standardized 30-day period payment rate is 
calculated in Table B34.
[GRAPHIC] [TIFF OMITTED] TP10JY23.058

    The CY 2024 national, standardized 30-day period payment rate for 
an HHA that does not submit the required quality data is updated by the 
proposed CY 2024 home health payment update percentage of 0.7 percent 
(2.7 percent minus 2 percentage points) and is shown in Table B35.
[GRAPHIC] [TIFF OMITTED] TP10JY23.059

(3) CY 2024 National Per-Visit Rates for 30-Day Periods of Care
    The national per-visit rates are used to pay LUPAs and are also 
used to compute imputed costs in outlier calculations. The per-visit 
rates are paid by type of visit or home health discipline. The six home 
health disciplines are as follows:
     Home health aide (HH aide).
     Medical Social Services (MSS).
     Occupational therapy (OT).
     Physical therapy (PT).
     Skilled nursing (SN).
     Speech-language pathology (SLP).
    To calculate the proposed CY 2024 national per-visit rates, we 
started with the CY 2023 national per-visit rates. Then we applied a 
wage index budget neutrality factor to ensure budget neutrality for 
LUPA per-visit payments. We calculated the wage index budget neutrality 
factor by simulating total payments for LUPA 30-day periods of care 
using the CY 2024 wage index with a 5-percent cap on wage index 
decreases and comparing it to simulated total payments for LUPA 30-day 
periods of care using the CY 2023 wage index with 5-percent cap. By 
dividing the total payments for LUPA 30-day periods of care using the 
CY 2024 wage index by the total payments for LUPA 30-day periods of 
care using the CY 2023 wage index, we obtained a wage index budget 
neutrality factor of 1.0015. We apply the wage index budget neutrality 
factor in order to calculate the CY 2024 national per-visit rates. In 
order to calculate the labor-related share budget neutrality factor for 
the national per visit amounts, we simulate total payments for LUPA 30-
day periods using CY 2022 home health utilization claims data with the 
CY 2024 HH PPS wage index and the proposed labor-related share (labor-
related share of 74.9 percent and non-labor-related share of 25.1 
percent) and compare it to our simulation of total payments for LUPA 
30-day periods using the CY 2024 HH PPS wage index with the current 
labor-related share (labor-related share of 76.1 percent and non-labor-
related share of 23.9 percent). By dividing the payment amounts for 
LUPA 30-day periods using the proposed labor-related share and CY 2024 
wage index and payment rate by the payment amounts for LUPA 30-day 
periods using the current labor-related share and CY 2024 wage index 
and payment rate, we obtain a labor-related share budget neutrality 
factor of 0.9999.
    The LUPA per-visit rates are not calculated using case-mix weights. 
Therefore, no case-mix weight budget neutrality factor is needed to 
ensure budget neutrality for LUPA payments. Additionally, we are not 
applying the

[[Page 43719]]

permanent adjustment to the per visit payment rates but only to the 
case-mix adjusted 30-day payment rate. Lastly, the per-visit rates for 
each discipline are updated by the proposed CY 2024 home health payment 
update percentage of 2.7 percent. The national per-visit rates are 
adjusted by the wage index based on the site of service of the 
beneficiary. The per-visit payments for LUPAs are separate from the 
LUPA add-on payment amount, which is paid for episodes that occur as 
the only episode or initial episode in a sequence of adjacent episodes. 
The CY 2024 national per-visit rates for HHAs that submit the required 
quality data are updated by the proposed CY 2024 home health payment 
update percentage of 2.7 percent and are shown in Table B36.
[GRAPHIC] [TIFF OMITTED] TP10JY23.060

    The CY 2024 per-visit payment rates for HHAs that do not submit the 
required quality data are updated by the proposed CY 2024 home health 
payment update percentage of 2.7 percent minus 2 percentage points and 
are shown in Table B37.
[GRAPHIC] [TIFF OMITTED] TP10JY23.061

(4) LUPA Add-On Factors
    Prior to the implementation of the 30-day unit of payment, LUPA 
episodes were eligible for a LUPA add-on payment if the episode of care 
was the first or only episode in a sequence of adjacent episodes. As 
stated in the CY 2008 HH PPS final rule, the average visit lengths in 
these initial LUPAs are 16 to 18 percent higher than the average visit 
lengths in initial non-LUPA episodes (72 FR 49848). LUPA episodes that 
occur as the only episode or as an initial episode in a sequence of 
adjacent episodes are adjusted by applying an additional amount to the 
LUPA payment before adjusting for area wage differences. In the CY 2014 
HH PPS final rule (78 FR 72305), we changed the methodology for 
calculating the LUPA add-on amount by finalizing the use of three LUPA 
add-on factors: 1.8451 for SN; 1.6700 for PT; and 1.6266 for SLP. We 
multiply the per-visit payment amount for the first SN, PT, or SLP 
visit in LUPA episodes that occur as the only episode or an initial 
episode in a sequence of adjacent episodes by the appropriate factor to 
determine the LUPA add-on payment amount.
    In the CY 2019 HH PPS final rule with comment period (83 FR 56440), 
in addition to finalizing a 30-day unit of payment, we finalized our 
policy of continuing to multiply the per-visit

[[Page 43720]]

payment amount for the first skilled nursing, physical therapy, or 
speech-language pathology visit in LUPA periods that occur as the only 
period of care or the initial 30-day period of care in a sequence of 
adjacent 30-day periods of care by the appropriate add-on factor 
(1.8451 for SN, 1.6700 for PT, and 1.6266 for SLP) to determine the 
LUPA add-on payment amount for 30-day periods of care under the PDGM. 
For example, using the proposed CY 2024 per-visit payment rates for 
HHAs that submit the required quality data, for LUPA periods that occur 
as the only period or an initial period in a sequence of adjacent 
periods, if the first skilled visit is SN, the payment for that visit 
would be $309.85 (1.8451 multiplied by $167.93), subject to area wage 
adjustment.
(5) Occupational Therapy LUPA Add-On Factor
    In order to implement Division CC, section 115, of CAA, 2021, CMS 
finalized changes to regulations at Sec.  484.55(a)(2) and (b)(3) that 
allowed occupational therapists to conduct initial and comprehensive 
assessments for all Medicare beneficiaries under the home health 
benefit when the plan of care does not initially include skilled 
nursing care, but either PT or SLP (86 FR 62351). This change, led to 
us establishing a LUPA add-on factor for calculating the LUPA add-on 
payment amount for the first skilled occupational therapy (OT) visit in 
LUPA periods that occurs as the only period of care or the initial 30-
day period of care in a sequence of adjacent 30-day periods of care.
    As stated in the CY 2022 HH PPS final rule with comment period (86 
FR 62289) since there was not sufficient data regarding the average 
excess of minutes for the first visit in LUPA periods when the initial 
and comprehensive assessments are conducted by occupational therapists 
we finalized the use of the PT LUPA add-on factor of 1.6700 as a proxy. 
We also stated that we would use the PT LUPA add-on factor as a proxy 
until we have CY 2022 data to establish a more accurate OT add-on 
factor for the LUPA add-on payment amounts (86 FR 62289). At this time, 
we are analyzing the CY 2022 data and will continue to use the PT LUPA 
add-on factor for OT LUPAs and plan to propose a LUPA add-on factor 
specific to OT in future rulemaking.
(6) Payments for High-Cost Outliers Under the HH PPS
(a) Background
    Section 1895(b)(5) of the Act allows for the provision of an 
addition or adjustment to the home health payment amount otherwise made 
in the case of outliers because of unusual variations in the type or 
amount of medically necessary care. Under the HH PPS and the previous 
unit of payment (that is, 60-day episodes), outlier payments were made 
for 60-day episodes whose estimated costs exceed a threshold amount for 
each HHRG. The episode's estimated cost was established as the sum of 
the national wage-adjusted per visit payment amounts delivered during 
the episode. The outlier threshold for each case-mix group or PEP 
adjustment defined as the 60-day episode payment or PEP adjustment for 
that group plus a fixed-dollar loss (FDL) amount. For the purposes of 
the HH PPS, the FDL amount is calculated by multiplying the home health 
FDL ratio by a case's wage-adjusted national, standardized 60-day 
episode payment rate, which yields an FDL dollar amount for the case. 
The outlier threshold amount is the sum of the wage and case-mix 
adjusted PPS episode amount and wage-adjusted FDL amount. The outlier 
payment is defined to be a proportion of the wage-adjusted estimated 
cost that surpasses the wage-adjusted threshold. The proportion of 
additional costs over the outlier threshold amount paid as outlier 
payments is referred to as the loss-sharing ratio.
    As we noted in the CY 2011 HH PPS final rule (75 FR 70397 through 
70399), section 3131(b)(1) of the Affordable Care Act amended section 
1895(b)(3)(C) of the Act to require that the Secretary reduce the HH 
PPS payment rates such that aggregate HH PPS payments were reduced by 5 
percent. In addition, section 3131(b)(2) of the Affordable Care Act 
amended section 1895(b)(5) of the Act by redesignating the existing 
language as section 1895(b)(5)(A) of the Act and revised the language 
to state that the total amount of the additional payments or payment 
adjustments for outlier episodes could not exceed 2.5 percent of the 
estimated total HH PPS payments for that year. Section 3131(b)(2)(C) of 
the Affordable Care Act also added section 1895(b)(5)(B) of the Act, 
which capped outlier payments as a percent of total payments for each 
HHA for each year at 10 percent.
    As such, beginning in CY 2011, we reduced payment rates by 5 
percent and targeted up to 2.5 percent of total estimated HH PPS 
payments to be paid as outliers. To do so, we first returned the 2.5 
percent held for the target CY 2010 outlier pool to the national, 
standardized 60-day episode rates, the national per visit rates, the 
LUPA add-on payment amount, and the NRS conversion factor for CY 2010. 
We then reduced the rates by 5 percent as required by section 
1895(b)(3)(C) of the Act, as amended by section 3131(b)(1) of the 
Affordable Care Act. For CY 2011 and subsequent calendar years we 
targeted up to 2.5 percent of estimated total payments to be paid as 
outlier payments, and apply a 10-percent agency-level outlier cap.
    In the CY 2017 HH PPS proposed and final rules (81 FR 43737 through 
43742 and 81 FR 76702), we described our concerns regarding patterns 
observed in home health outlier episodes. Specifically, we noted the 
methodology for calculating home health outlier payments may have 
created a financial incentive for providers to increase the number of 
visits during an episode of care in order to surpass the outlier 
threshold; and simultaneously created a disincentive for providers to 
treat medically complex beneficiaries who require fewer but longer 
visits. Given these concerns, in the CY 2017 HH PPS final rule (81 FR 
76702), we finalized changes to the methodology used to calculate 
outlier payments, using a cost-per-unit approach rather than a cost-
per-visit approach. This change in methodology allows for more accurate 
payment for outlier episodes, accounting for both the number of visits 
during an episode of care and the length of the visits provided. Using 
this approach, we now convert the national per-visit rates into per 15-
minute unit rates. These per 15-minute unit rates are used to calculate 
the estimated cost of an episode to determine whether the claim will 
receive an outlier payment and the amount of payment for an episode of 
care. In conjunction with our finalized policy to change to a cost-per-
unit approach to estimate episode costs and determine whether an 
outlier episode should receive outlier payments, in the CY 2017 HH PPS 
final rule we also finalized the implementation of a cap on the amount 
of time per day that would be counted toward the estimation of an 
episode's costs for outlier calculation purposes (81 FR 76725). 
Specifically, we limit the amount of time per day (summed across the 
six disciplines of care) to 8 hours (32 units) per day when estimating 
the cost of an episode for outlier calculation purposes.
    In the CY 2017 HH PPS final rule (81 FR 76724), we stated that we 
did not plan to re-estimate the average minutes per visit by discipline 
every year.

[[Page 43721]]

Additionally, the per unit rates used to estimate an episode's cost 
were updated by the home health update percentage each year, meaning we 
would start with the national per visit amounts for the same calendar 
year when calculating the cost-per-unit used to determine the cost of 
an episode of care (81 FR 76727). We will continue to monitor the visit 
length by discipline as more recent data becomes available, and may 
propose to update the rates as needed in the future.
    In the CY 2019 HH PPS final rule with comment period (83 FR 56521), 
we finalized a policy to maintain the current methodology for payment 
of high-cost outliers upon implementation of PDGM beginning in CY 2020 
and calculated payment for high-cost outliers based upon 30-day period 
of care. Upon implementation of the PDGM and 30-day unit of payment, we 
finalized the FDL ratio of 0.56 for 30-day periods of care in CY 2020. 
Given that CY 2020 was the first year of the PDGM and the change to a 
30-day unit of payment, we finalized maintaining the same FDL ratio of 
0.56 in CY 2021 as we did not have sufficient CY 2020 data at the time 
of CY 2021 rulemaking to propose a change to the FDL ratio for CY 2021. 
In the CY 2022 HH PPS final rule with comment period (86 FR 62292), we 
estimated that outlier payments would be approximately 1.8 percent of 
total HH PPS final rule payments if we maintained an FDL of 0.56 in CY 
2022. Therefore, in order to pay up to, but no more than, 2.5 percent 
of total payments as outlier payments we finalized an FDL of 0.40 for 
CY 2022. In the CY 2023 HH PPS final rule (87 FR 66875), using CY 2021 
claims utilization data, we finalized an FDL of 0.35 in order to pay up 
to, but no more than, 2.5 percent of the total payment as outlier 
payments in CY 2023.
(b) Proposed FDL Ratio for CY 2024
    For a given level of outlier payments, there is a trade-off between 
the values selected for the FDL ratio and the loss-sharing ratio. A 
high FDL ratio reduces the number of periods that can receive outlier 
payments, but makes it possible to select a higher loss-sharing ratio, 
and therefore, increase outlier payments for qualifying outlier 
periods. Alternatively, a lower FDL ratio means that more periods can 
qualify for outlier payments, but outlier payments per period must be 
lower.
    The FDL ratio and the loss-sharing ratio are selected so that the 
estimated total outlier payments do not exceed the 2.5 percent 
aggregate level (as required by section 1895(b)(5)(A) of the Act). 
Historically, we have used a value of 0.80 for the loss-sharing ratio, 
which, we believe, preserves incentives for agencies to attempt to 
provide care efficiently for outlier cases. With a loss-sharing ratio 
of 0.80, Medicare pays 80 percent of the additional estimated costs 
that exceed the outlier threshold amount. Using CY 2022 claims data (as 
of March 17, 2023) and given the statutory requirement that total 
outlier payments do not exceed 2.5 percent of the total payments 
estimated to be made under the HH PPS, we are proposing an FDL ratio of 
0.31 for CY 2024. CMS will update the FDL, if needed, once we have more 
complete CY 2022 claims data.
5. Proposal for Disposable Negative Pressure Wound Therapy
(1) Background
    Negative pressure wound therapy (NPWT) is a medical procedure in 
which a vacuum dressing is used to enhance and promote healing in 
acute, chronic, and burn wounds. The therapy involves using a sealed 
wound dressing attached to a pump to create a negative pressure 
environment in the wound. Applying continued or intermittent vacuum 
pressure helps to increase blood flow to the area and draw out excess 
fluid from the wound. Moreover, the therapy promotes wound healing by 
preparing the wound bed for closure, reducing edema, promoting 
granulation tissue formation and perfusion, and removing exudate and 
infectious material. The wound type and the location of the wound 
determine whether the vacuum can either be applied continuously or 
intermittently. NPWT can be utilized for varying lengths of time, as 
indicated by the severity of the wound, from a few days of use up to a 
span of several months.
    The therapy can be administered using the conventional NPWT system, 
classified as durable medical equipment (DME), or can be administered 
using a disposable device. A disposable NPWT (dNPWT) device is a 
single-use integrated system that consists of a non-manual vacuum pump, 
a receptacle for collecting exudate, and wound dressings. Unlike 
conventional NPWT systems classified as DME, dNPWT devices have preset 
continuous negative pressure, no intermittent setting, are pocket-sized 
and easily transportable, and are generally battery-operated with 
disposable batteries.
    In order for a beneficiary to receive dNPWT under the home health 
benefit, the beneficiary must qualify for the home health benefit in 
accordance with existing eligibility requirements. To be eligible for 
Medicare home health services, as set out in sections 1814(a) and 
1835(a) of the Act, a physician must certify that the Medicare 
beneficiary (patient) meets the following criteria:
     Is confined to the home.
     Needs skilled nursing care on an intermittent basis or 
physical therapy or speech-language pathology; or have a continuing 
need for occupational therapy.
     Is under the care of a physician.
     Receive services under a plan of care established and 
reviewed by a physician.
     Has had a face-to-face encounter related to the primary 
reason for home health care with a physician or allowed Non-Physician 
Practitioner (NPP) within a required timeframe.
    Coverage for dNPWT is determined based upon a doctor's order as 
well as patient preference. Treatment decisions as to whether to use a 
dNPWT system versus a conventional NPWT DME system are determined by 
the characteristics of the wound, as well as patient goals and 
preferences discussed with the ordering physician to best achieve wound 
healing.
(2) Current Payment for Negative Pressure Wound Therapy Using a 
Disposable Device
    Prior to CY 2017, a dNPWT system was considered a non-routine 
supply and thus payment for the disposable device was included in the 
episode payment amount under the previous home health payment system. 
However, section 504 of the CAA, 2016 (Pub. L. 114-113) amended both 
section 1834 of the Act (42 U.S.C. 1395m) and section 1861(m)(5) of the 
Act (42 U.S.C. 1395x(m)(5)), and required a separate payment for an 
applicable disposable device when furnished on or after January 1, 
2017, to an individual who receives home health services for which 
payment is made under the Medicare home health benefit. Therefore, in 
the CY 2017 HH PPS final rule (81 FR 76736), we finalized the 
implementation of several changes in payment for furnishing dNPWT for a 
patient under a home health plan of care beginning in CY 2017, and each 
subsequent year. These payment changes included the implementation of a 
separate payment amount for dNPWT that was set equal to the amount of 
the payment that would be made under the Medicare Hospital Outpatient 
Prospective Payment System (OPPS) using the CPT codes 97607 and 97608. 
This separate payment amount included furnishing the service as well as 
the dNPWT device. As a reminder, codes 97607 and 97608 are defined as 
follows:
     HCPCS 97607--Negative pressure wound therapy, (for 
example, vacuum

[[Page 43722]]

assisted drainage collection), utilizing disposable, non-durable 
medical equipment including provision of exudate management collection 
system, topical application(s), wound assessment, and instructions for 
ongoing care, per session; total wound(s) surface area less than or 
equal to 50 square centimeters.
     HCPCS 97608--Negative pressure wound therapy, (for 
example, vacuum assisted drainage collection), utilizing disposable, 
non-durable medical equipment including provision of exudate management 
collection system, topical application(s), wound assessment, and 
instructions for ongoing care, per session; total wound(s) surface area 
greater than 50 square centimeters.
    We also finalized that for instances where the sole purpose of a 
home health visit is to furnish dNPWT, Medicare does not pay for the 
visit under the HH PPS. Visits performed solely for the purposes of 
furnishing a new dNPWT device are not reported on the HH PPS claim (TOB 
32x). Where a home health visit is exclusively for the purpose of 
furnishing dNPWT, the HHA submits only a TOB 34x. However, if the home 
health visit includes the provision of other home health services in 
addition to, and separate from, furnishing dNPWT, the HHA submits both 
a TOB 32x and TOB 34x--the TOB 32x for other home health services and 
the TOB 34x for furnishing NPWT using a disposable device. Payment for 
home health visits related to wound care, but not requiring the 
furnishing of an entirely new dNPWT device, are covered by the HH PPS 
30-day period payment and must be billed using the home health claim.
(3) CAA, 2023
    Division FF, section 4136 of the CAA, 2023 (Pub. L.117-328) amends 
section 1834 of the Act (42 U.S.C. 1395m(s)), and mandates several 
amendments to the Medicare separate payment for dNPWT devices beginning 
in CY 2024. Section 4136(a) of the CAA, 2023 amends 1834(s)(3) of the 
Act by adding subparagraph (A) which outlines the calculation of the 
payment amounts for (i) years prior to CY 2024, (ii) CY 2024, (iii) CY 
2025; and each subsequent year. As discussed previously, for a year 
prior to CY 2024, the amount of the separate payment was set equal to 
the amount of the payment that would be made under the Medicare 
Hospital OPPS using the CPT codes 97607 and 97608 and included the 
professional service as well as the furnishing of the device. For CY 
2024, the CAA, 2023 requires that the separate payment amount for an 
applicable dNPWT device would be set equal to the supply price used to 
determine the relative value for the service under the Physician Fee 
Schedule (PFS) under section 1848 as of January 1, 2022 (CY 2022) 
updated by the specified adjustment described in subparagraph (B) for 
such year. For 2025 and each subsequent year, the CAA, 2023 requires 
that the separate payment amount will be set equal to the payment 
amount established for the device in the previous year, updated by the 
specified adjustment described in subparagraph (B) for such year.
    Division FF section 4136 of the CAA, 2023 also adds a new 
subparagraph 1834(s)(3)(B), which requires that the separate payment 
amount to be adjusted by the percent increase in the CPI-U for the 12-
month period ending with June of the preceding year minus the 
productivity adjustment described in section 1886(b)(3)(B)(xi)(II) for 
such year. Accordingly, this may result in a percentage being less than 
0.0 for a year, and may result in payment being less than such payment 
rates for the preceding year.
    Section 1834(s)(3)(C) of the Act, as added by Division FF, section 
4136 of the CAA, 2023, specifies that the separate payment amount for 
applicable devices furnished on or after January 1, 2024, would no 
longer include payment for nursing or therapy services described in 
section 1861(m) of the Act. Payment for such nursing or therapy 
services would now be made under the prospective payment system 
established under section 1895 of the Act, the HH PPS, and is no longer 
separately billable.
    Division FF, section 4136 of the CAA, 2023 also added a new 
paragraph 1834(s)(4) of the Act that mandates a change in claims 
processing for the separate payment amount for an applicable disposable 
device. Beginning in CY 2024 and each subsequent year, claims for the 
separate payment amount of an applicable dNPWT device would now be 
accepted and processed on claims submitted using the type of bill that 
is most commonly used by home health agencies to bill services under a 
home health plan of care (TOB 32X). That is, claims with a date of 
service on or after January 1, 2024 for an applicable dNPWT device will 
no longer be submitted on TOB 34X.
(4) Proposed Payment Policies for dNPWT Devices
    For the purposes of paying for a dNPWT device for a patient under a 
Medicare home health plan of care, CMS is proposing that the payment 
amount for CY 2024 would be equal to the supply price of the applicable 
disposable device under the Medicare PFS (as of January 1, 2022) 
updated by the specified adjustment as mandated by the CAA, 2023. The 
supply price of an applicable disposable device under the Medicare PFS 
for January 1, 2022 is $263.25. Therefore, the payment amount for CY 
2024 would be set equal to the amount of $263.25 updated by the percent 
increase in the CPI-U for the 12-month period ending in June of 2023 
minus the productivity adjustment. We note that the CPI-U for the 12-
month period ending with June of 2023 is not available at the time of 
this proposed rulemaking. The CPI-U for the 12-month period ending in 
June of 2023 and the corresponding productivity adjustment will be 
updated in the final rule. We are also proposing that the separate 
payment for CY 2025 and each subsequent year would be based on the 
established payment amount for the previous calendar year updated by 
the percentage increase in the CPI-U minus the productivity adjustment 
for the 12-month period ending in June of the previous year. The 
application of productivity adjustment may result in a net update that 
may be less than 0.0 for a year, and may result in the separate payment 
amount under this subsection for an applicable device for a year being 
less than such separate payment amount for such device for the 
preceding year.
    In accordance with the changes made by the CAA, 2023, we are also 
proposing that claims reported for a dNPWT device would no longer be 
reported on TOB 34x. Instead, for dates of service beginning on or 
after January 1, 2024, the HHA would report the Healthcare Common 
Procedure Coding System (HCPCS) code A9272 (for the device only) on the 
home health type of bill TOB 32. The code HCPCS A9272 is defined as a 
wound suction, disposable, includes dressing, all accessories and 
components, any type, each. We will provide education and develop 
materials outlining the new billing procedures for dNPWT under the home 
health benefit including MLN Matters[supreg] articles and manual 
guidance after publication of the CY 2024 HH PPS final rule.
    We are also proposing that the services related to the application 
of the device would be included in the HH PPS and would be excluded 
from the separate payment amount for the device. In addition, only the 
home health services for the administration of the device would be 
geographically adjusted and the payment amount for HCPCS A9272 would 
not be subject to geographic adjustment.
    We are soliciting public comment on all aspects of the proposed 
payment

[[Page 43723]]

policies for furnishing a dNPWT device as articulated in this section 
as well as the corresponding proposed regulations text changes at Sec.  
409.50 and Sec.  484.202.

III. Home Health Quality Reporting Program (HH QRP)

A. Background and Statutory Authority

    The HH QRP is authorized by section 1895(b)(3)(B)(v) of the Act. 
Section 1895(b)(3)(B)(v)(II) of the Act requires that, for 2007 and 
subsequent years, each home health agency (HHA) submit to the Secretary 
in a form and manner, and at a time, specified by the Secretary, such 
data that the Secretary determines are appropriate for the measurement 
of health care quality. To the extent that an HHA does not submit data 
in accordance with this clause, the Secretary shall reduce the home 
health market basket percentage increase applicable to the HHA for such 
year by 2 percentage points. As provided at section 1895(b)(3)(B)(vi) 
of the Act, depending on the market basket percentage increase 
applicable for a particular year, as further reduced by the 
productivity adjustment (except in 2018 and 2020) described in section 
1886(b)(3)(B)(xi)(II) of the Act, the reduction of that increase by 2 
percentage points for failure to comply with the requirements of the HH 
QRP may result in the home health market basket percentage increase 
being less than 0.0 percent for a year, and may result in payment rates 
under the Home Health PPS for a year being less than payment rates for 
the preceding year. Section 1890A of the Act requires that the 
Secretary establish and follow a pre-rulemaking process, in 
coordination with the consensus-based entity (CBE) with a contract 
under section 1890 of the Act, to solicit input from certain groups 
regarding the selection of quality and efficiency measures for the HH 
QRP. The HH QRP regulations can be found at 42 CFR 484.245 and 484.250.
    In this proposed rule, we are proposing to adopt two new measures 
and remove one existing measure. Second, we propose the removal of two 
OASIS items. Third, we are proposing to begin public reporting of four 
measures in the HH QRP. Fourth, we are providing an update on our 
efforts to close the health equity gap. Fifth, we propose codifying of 
our 90 percent data submission threshold policy in the Code of Federal 
Regulations. Lastly, we are seeking information on principles we could 
use to select and prioritize HH QRP quality measures in future years. 
These proposals are further specified in the following sections.

B. General Considerations Used for the Selection of Quality Measures 
for the HH QRP

    For a detailed discussion of the considerations we historically use 
for measure selection for the HH QRP quality, resource use, and other 
measures, we refer readers to the CY 2016 HH PPS final rule (80 FR 
68695 through 68696). In the CY 2019 HH PPS final rule with comment 
period (83 FR 56548 through 56550) we finalized the factors we consider 
for removing previously adopted HH QRP measures.

C. Quality Measures Currently Adopted for the CY 2024 HH QRP

    The HH QRP currently includes 20 measures for the CY 2023 program 
year, as described in Table C1.
BILLING CODE 4120-01-P

[[Page 43724]]

[GRAPHIC] [TIFF OMITTED] TP10JY23.062


[[Page 43725]]


BILLING CODE 4120-01-C

D. HH QRP Quality Measure Proposals Beginning With the CY 2025 HH QRP

1. Discharge Function Score Measure Beginning With the CY 2025 HH QRP
a. Background
    Eligibility for Medicare's home health benefit stipulates that 
beneficiaries must need part-time (fewer than eight hours per day) or 
intermittent skilled care for their medical conditions and be unable to 
leave their homes without considerable effort. Unlike skilled nursing 
facilities, a proceeding hospital stay is not required for 
beneficiaries to access the Medicare home health benefit.\18\ HH 
patients frequently have complex medical issues, including cardiac, 
circulatory and respiratory conditions, and between 30-40 percent of HH 
patients begin their episode of care with a high level of functional 
debility.\19\ Measuring functional status of HH patients can provide 
valuable information about an HHA's quality of care. A patient's 
functional status is associated with institutionalization,\20\ higher 
risk of falls and falls-related hip fracture and death,21 22 
greater risk of undernutrition,\23\ higher emergency department 
admissions,\24\ higher risk of readmissions following home care 
25 26 and higher prevalence of hypertension and 
diabetes.\27\ Predictors of poorer recovery in function include greater 
age, complications after hospital discharge, and residence in a nursing 
home.\28\ Understanding factors associated with poorer functional 
recovery facilitates the ability to estimate expected functional 
outcome recovery for patients, based on their personal characteristics.
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    \18\ Medicare Payment Advisory Commission. (2022). March 2022 
report to the congress: Medicare payment policy. Washington, DC: 
Medicare Payment Advisory Commission.
    \19\ Medicare Payment Advisory Commission. (2022). March 2022 
report to the congress: Medicare payment policy. Washington, DC: 
Medicare Payment Advisory Commission.
    \20\ Hajek, A., Brettschneider, C., Lange, C., Posselt, T., 
Wiese, B., Steinmann, S., Weyerer, S., Werle, J., Pentzek, M., 
Fuchs, A., Stein, J., Luck, T., Bickel, H., M[ouml]sch, E., Wagner, 
M., Jessen, F., Maier, W., Scherer, M., Riedel-Heller, S.G., 
K[ouml]nig, H.H., & AgeCoDe Study Group. (2015). Longitudinal 
Predictors of Institutionalization in Old Age. PLoS One, 
10(12):e0144203.
    \21\ Akahane, M., Maeyashiki, A., Yoshihara, S., Tanaka, Y., & 
Imamura, T. (2016). Relationship between difficulties in daily 
activities and falling: loco-check as a self-assessment of fall 
risk. Interactive Journal of Medical Research, 5(2), e20.
    \22\ Zaslavsky, O., Zelber-Sagi, S., Gray, S.L., LaCroix, A.Z., 
Brunner, R.L., Wallace, R.B., . . . Woods, N.F. (2016). Comparison 
of Frailty Phenotypes for Prediction of Mortality, Incident Falls, 
and Hip Fracture in Older Women. Journal of the American Geriatrics 
Society, 64(9), 1858-1862.
    \23\ van der Pols-Vijlbrief, R., Wijnhoven, H.A.H., Bosmans, 
J.E., Twisk, J.W.R., & Visser, M. (2016). Targeting the underlying 
causes of undernutrition. Cost-effectiveness of a multifactorial 
personalized intervention in community-dwelling older adults: A 
randomized controlled trial. Clinical Nutrition (Edinburgh, 
Scotland).
    \24\ Hominick, K., McLeod, V., & Rockwood, K. (2016). 
Characteristics of older adults admitted to hospital versus those 
discharged home, in emergency department patients referred to 
internal medicine. Canadian Geriatrics Journal: CGJ, 19(1), 9-14.
    \25\ Knox, S., Downer, B., Haas, A., Middleton, A., & 
Ottenbacher, K.J. (2020). Function and caregiver support associated 
with readmissions during home health for individuals with dementia. 
Archives of physical medicine and rehabilitation, 101(6), 1009-1016.
    \26\ Middleton, A. Downer, B., Haas, A., Knox, S., & 
Ottenbacher, K.J. (2019) Functional status ss associated with 30-day 
potentially preventable readmissions following home health Care. 
Medical Care, 57(2):145-151.
    \27\ Halaweh, H., Willen, C., Grimby-Ekman, A., & Svantesson, U. 
(2015). Physical activity and health-related quality of life among 
community dwelling elderly. J Clin Med Res, 7(11), 845-52.
    \28\ C[oacute]rcoles-Jim[eacute]nez, M.P., Villada-Munera, A., 
Del Egido-Fernandez, M.A., Candel-Parra, E., Moreno-Moreno, M., 
Jimenez-Sanchez, M.D., & Pina-Martinez, A. (2015). Recovery of 
activities of daily living among older people one year after hip 
fracture. Clinical Nursing Research, 24(6), 604-623.
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    Home health care can positively impact functional outcomes. There 
is evidence the provision of home care services can lead to 
statistically significant improvements in function and successful 
discharge into the community.\29\ In stroke patients, home-based 
rehabilitation programs administered by home health clinicians 
significantly improved function.\30\ Home health services, delivered by 
a registered nurse positively impacted patient Quality of Life (QOL) 
and clinical outcomes, including significant improvement in dressing 
lower body and bathing activities of daily living, meal preparation, 
shopping, and housekeeping instrumental activities of daily living.\31\ 
In addition, a retrospective study, using data abstracted from the 
Minimum Data Set and OASIS, reported that nursing home admissions were 
delayed in the study population receiving home health services by an 
average of eight months \32\ and for a similar population, community 
dwelling adults receiving community-based services supporting aging in 
place, health and functional outcomes were enhanced, and improved 
cognition and lower rates of depression, function assistance, and 
incontinence were noted.\33\
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    \29\ Bowles, K.H., McDonald, M., Barron, Y., Kennedy, E., 
O'Connor, M., & Mikkelsen, M. (2021). Surviving COVID-19 after 
hospital discharge: symptom, functional, and adverse outcomes of 
home health recipients. Annals of internal medicine, 174(3), 316-
325.
    \30\ Asiri, F.Y., Marchetti, G.F., Ellis, J.L., Otis, L., 
Sparto, P.J., Watzlaf, V., & Whitney, S.L. (2014). Predictors of 
functional and gait outcomes for persons poststroke undergoing home-
based rehabilitation. Journal of Stroke and Cerebrovascular 
Diseases: The Official Journal of National Stroke Association, 
23(7), 1856-1864.
    \31\ C[oacute]rcoles-Jim[eacute]nez, M.P., Villada-Munera, A., 
Del Egido-Fernandez, M.A., Candel-Parra, E., Moreno-Moreno, M., 
Jimenez-Sanchez, M.D., & Pina-Martinez, A. (2015). Recovery of 
activities of daily living among older people one year after hip 
fracture. Clinical Nursing Research, 24(6), 604-623.
    \32\ Asiri, F.Y., Marchetti, G.F., Ellis, J.L., Otis, L., 
Sparto, P.J., Watzlaf, V., & Whitney, S.L. (2014). Predictors of 
functional and gait outcomes for persons poststroke undergoing home-
based rehabilitation. Journal of Stroke and Cerebrovascular 
Diseases: The Official Journal of National Stroke Association, 
23(7), 1856-1864.
    \33\ Han, S.J., Kim, H.K., Storfjell, J., & Kim, M.J. (2013). 
Clinical outcomes and quality of life of home health care patients. 
Asian Nursing Research, 7(2), 53-60.
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    To satisfy the requirement of the Improving Medicare Post-Acute 
Care Transformation (IMPACT) Act of 2014 (Pub. L. 113-185) to develop 
and implement standardized quality measures from five quality measure 
domains, including the domain of functional status, cognitive function, 
and changes in function and cognitive function, across the post-acute 
care (PAC) settings, CMS adopted the ``Application of Percent of Long-
Term Care Hospital Patients with an Admission and Discharge Functional 
Assessment and a Care Plan That Addresses Function'' (Application of 
Functional Assessment/Care Plan) measure in the CY 2018 HH PPS final 
rule (82 FR 51722 through 51725). This cross-setting process measure 
allowed for the standardization of functional assessments across 
assessment instruments and facilitated cross-setting data collection, 
quality measurement, and interoperable data exchange.
    However, performance on this measure across the PAC settings, 
including the range of HHAs, is so high and unvarying across most HH 
providers that the measure no longer offers meaningful distinctions in 
performance. Several measures addressing functional status are 
currently part of the PAC QRPs. None of the existing functional outcome 
measures are cross-setting in nature, in that they are either (a) not 
implemented in all four settings (for instance, the ``Discharge 
Mobility and Self-Care Score'' measures are reported for SNFs and IRFs 
but not for LTCHs and HHAs); or (b) rely on functional status items not 
collected in all settings (for instance, the ``Discharge Mobility and 
Self-Care Score'' measures rely on items not collected in LTCHs). In 
contrast, a cross-setting functional outcome measure would include the 
HH setting. Moreover, the measure specifications would be aligned 
across settings, including the use of a common set of standardized 
functional assessment data

[[Page 43726]]

elements, thereby satisfying the requirements of the IMPACT Act.
(1) Measure Importance
    Maintenance or improvement of physical function among older adults 
is increasingly an important focus of healthcare. Worldwide, close to 
20 percent of older adults living at home report needing some form of 
assistance with their ADLs, and in the US 29 percent of older adults 
report difficulties completing their activities of daily living 
(ADLs).\34\ Adults aged 65 years and older constitute the most rapidly 
growing population in the United States, and functional capacity in 
physical (non-psychological) domains has been shown to decline with 
age.\35\ Moreover, impaired functional capacity is associated with 
poorer quality of life and an increased risk of all-cause mortality, 
postoperative complications, and cognition, the latter of which can 
complicate the return of a patient to the community from post-acute 
care if the patient exhibits cognitive deficits.36 37 38 
Nonetheless, evidence suggests that physical functional abilities, 
including mobility and self-care, are modifiable predictors of patient 
outcomes across PAC settings, including functional recovery or decline 
after post-acute care,39 40 41 42 43 rehospitalization 
rates,44 45 46 discharge to community,47 48 and 
falls.\49\
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    \34\ Chen, S., Jones, L.A., Jiang, S., Jin, H., Dong, D., Chen, 
X., . . . Zhu, A. (2022). Difficulty and help with activities of 
daily living among older adults living alone during the COVID-19 
pandemic: a multi-country population-based study. BMC geriatrics, 
22(1), 1-14.
    \35\ High KP, Zieman S, Gurwitz J, Hill C, Lai J, Robinson T, 
Schonberg M, Whitson H. Use of Functional Assessment to Define 
Therapeutic Goals and Treatment. J Am Geriatr Soc. 2019 
Sep;67(9):1782-1790. doi: 10.1111/jgs.15975. Epub 2019 May 13. PMID: 
31081938; PMCID: PMC6955596.
    \36\ Clouston SA, Brewster P, Kuh D, Richards M, Cooper R, Hardy 
R, Rubin MS, Hofer SM. The dynamic relationship between physical 
function and cognition in longitudinal aging cohorts. Epidemiol Rev. 
2013;35(1):33-50. doi: 10.1093/epirev/mxs004. Epub 2013 Jan 24. 
PMID: 23349427; PMCID: PMC3578448.
    \37\ Michael YL, Colditz GA, Coakley E, Kawachi I. Health 
Behaviors, Social Networks, and Healthy Aging: Cross-Sectional 
Evidence from the Nurses' Health Study. Qual Life Res. 1999 
Dec;8(8):711-22. doi: 10.1023/a:1008949428041. PMID: 10855345.
    \38\ High KP, Zieman S, Gurwitz J, Hill C, Lai J, Robinson T, 
Schonberg M, Whitson H. Use of Functional Assessment to Define 
Therapeutic Goals and Treatment. J Am Geriatr Soc. 2019 
Sep;67(9):1782-1790. doi: 10.1111/jgs.15975. Epub 2019 May 13. PMID: 
31081938; PMCID: PMC6955596.
    \39\ Deutsch A, Palmer L, Vaughan M, Schwartz C, McMullen T. 
Inpatient Rehabilitation Facility Patients' Functional Abilities and 
Validity Evaluation of the Standardized Self-Care and Mobility Data 
Elements. Arch Phys Med Rehabil. 2022 Feb 11:S0003-9993(22)00205-2. 
doi: 10.1016/j.apmr.2022.01.147. Epub ahead of print. PMID: 
35157893.
    \40\ Hong I, Goodwin JS, Reistetter TA, Kuo YF, Mallinson T, 
Karmarkar A, Lin YL, Ottenbacher KJ. Comparison of Functional Status 
Improvements Among Patients With Stroke Receiving Postacute Care in 
Inpatient Rehabilitation vs Skilled Nursing Facilities. JAMA Netw 
Open. 2019 Dec 2;2(12):e1916646. doi: 10.1001/
jamanetworkopen.2019.16646. PMID: 31800069; PMCID: PMC6902754.
    \41\ Alcusky M, Ulbricht CM, Lapane KL. Postacute Care Setting, 
Facility Characteristics, and Poststroke Outcomes: A Systematic 
Review. Arch Phys Med Rehabil. 2018;99(6):1124-1140.e9. doi: 
10.1016/j.apmr.2017.09.005. PMID: 28965738; PMCID: PMC5874162.
    \42\ Chu CH, Quan AML, McGilton KS. Depression and Functional 
Mobility Decline in Long Term Care Home Residents with Dementia: a 
Prospective Cohort Study. Can Geriatr J. 2021;24(4):325-331. 
doi:10.5770/cgj.24.511. PMID: 34912487; PMCID: PMC8629506.
    \43\ Lane NE, Stukel TA, Boyd CM, Wodchis WP. Long-Term Care 
Residents' Geriatric Syndromes at Admission and Disablement Over 
Time: An Observational Cohort Study. J Gerontol A Biol Sci Med Sci. 
2019;74(6):917-923. doi: 10.1093/gerona/gly151. PMID: 29955879; 
PMCID: PMC6521919.
    \44\ Li CY, Haas A, Pritchard KT, Karmarkar A, Kuo YF, Hreha K, 
Ottenbacher KJ. Functional Status Across Post-Acute Settings is 
Associated With 30-Day and 90-Day Hospital Readmissions. J Am Med 
Dir Assoc. 2021 Dec;22(12):2447-2453.e5. doi: 10.1016/
j.jamda.2021.07.039. Epub 2021 Aug 30. PMID: 34473961; PMCID: 
PMC8627458.
    \45\ Middleton A, Graham JE, Lin YL, Goodwin JS, Bettger JP, 
Deutsch A, Ottenbacher KJ. Motor and Cognitive Functional Status Are 
Associated with 30-day Unplanned Rehospitalization Following Post-
Acute Care in Medicare Fee-for-Service Beneficiaries. J Gen Intern 
Med. 2016 Dec;31(12):1427-1434. doi: 10.1007/s11606-016-3704-4. Epub 
2016 Jul 20. PMID: 27439979; PMCID: PMC5130938.
    \46\ Gustavson AM, Malone DJ, Boxer RS, Forster JE, Stevens-
Lapsley JE. Application of High-Intensity Functional Resistance 
Training in a Skilled Nursing Facility: An Implementation Study. 
Phys Ther. 2020;100(10):1746-1758. doi: 10.1093/ptj/pzaa126. PMID: 
32750132; PMCID: PMC7530575.
    \47\ Minor M, Jaywant A, Toglia J, Campo M, O'Dell MW. Discharge 
Rehabilitation Measures Predict Activity Limitations in Patients 
with Stroke Six Months after Inpatient Rehabilitation. Am J Phys Med 
Rehabil. 2021 Oct 20. doi: 10.1097/PHM.0000000000001908. Epub ahead 
of print. PMID: 34686630.
    \48\ Dubin R, Veith JM, Grippi MA, McPeake J, Harhay MO, 
Mikkelsen ME. Functional Outcomes, Goals, and Goal Attainment among 
Chronically Critically Ill Long-Term Acute Care Hospital Patients. 
Ann Am Thorac Soc. 2021;18(12):2041-2048. doi: 10.1513/
AnnalsATS.202011-1412OC. PMID: 33984248; PMCID: PMC8641806.
    \49\ Hoffman GJ, Liu H, Alexander NB, Tinetti M, Braun TM, Min 
LC. Posthospital Fall Injuries and 30-Day Readmissions in Adults 65 
Years and Older. JAMA Netw Open. 2019 May 3;2(5):e194276. doi: 
10.1001/jamanetworkopen.2019.4276. PMID: 31125100; PMCID: 
PMC6632136.
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    The implementation of interventions that improve patients' 
functional outcomes and reduce the risks of associated undesirable 
outcomes as a part of a patient-centered care plan is essential to 
maximizing functional improvement. For many people, the overall goals 
of HH care may include optimizing functional improvement, returning to 
a previous level of independence, maintaining functional abilities, or 
avoiding institutionalization. Studies have suggested that HH care has 
the potential to improve patients' functional abilities including the 
performance of ADLs at discharge through the provision of physical and 
occupational therapy services for community dwelling older adult 
patients with various diagnoses, including 
dementia.50 51 52 53 54 55 Assessing functional status as a 
health outcome in HH can thus provide valuable information in 
determining treatment decisions throughout the care continuum, the need 
for therapy service, and discharge planning,56 57 58 as well 
as provide information to consumers about the effectiveness of the care 
delivered. Because evidence shows that older adults experience aging 
heterogeneously and require individualized and comprehensive health 
care, functional status can serve as a vital component in informing the 
provision of health care

[[Page 43727]]

and thus indicate HH quality of care.59 60 61 62
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    \50\ Knox, S., Downer, B., Haas, A., & Ottenbacher, K.J. (2022). 
Home health utilization association with discharge to community for 
people with dementia. Alzheimer's & Dementia: Translational Research 
& Clinical Interventions, 8(1), e12341.
    \51\ Prvu Bettger, J., McCoy, L., Smith, E.E., Fonarow, G.C., 
Schwamm, L.H., & Peterson, E.D. (2015). Contemporary trends and 
predictors of postacute service use and routine discharge home after 
stroke. Journal of the American Heart Association, 4(2), e001038.
    \52\ Golding-Day M, Whitehead P, Radford K, Walker M. 
Interventions to reduce dependency in bathing in community dwelling 
older adults: a systematic review. Syst Rev. 2017 Oct 11;6(1):198. 
doi: 10.1186/s13643-017-0586-4. PMID: 29020974; PMCID: PMC5637353.
    \53\ Foster, E.R., Carson, L. G., Archer, J., & Hunter, E.G. 
(2021). Occupational therapy interventions for instrumental 
activities of daily living for adults with Parkinson's disease: A 
systematic review. The American Journal of Occupational Therapy, 
75(3).
    \54\ Anderson, W.L., & Wiener, J.M. (2015). The impact of 
assistive technologies on formal and informal home care. The 
Gerontologist, 55(3), 422-433.
    \55\ Knox, S., Downer, B., Haas, A., Middleton, A., & 
Ottenbacher, K.J. (2020). Function and caregiver support associated 
with readmissions during home health for individuals with dementia. 
Archives of physical medicine and rehabilitation, 101(6), 1009-1016.
    \56\ Dubin R, Veith JM, Grippi MA, McPeake J, Harhay MO, 
Mikkelsen ME. Functional Outcomes, Goals, and Goal Attainment among 
Chronically Critically Ill Long-Term Acute Care Hospital Patients. 
Ann Am Thorac Soc. 2021;18(12):2041-2048. doi:10.1513/
AnnalsATS.202011-1412OC. PMID: 33984248; PMCID: PMC8641806.
    \57\ Warren M, Knecht J, Verheijde J, Tompkins J. Association of 
AM-PAC ``6-Clicks'' Basic Mobility and Daily Activity Scores With 
Discharge Destination. Phys Ther. 2021 Apr 4;101(4): pzab043. doi: 
10.1093/ptj/pzab043. PMID: 33517463.
    \58\ Cogan AM, Weaver JA, McHarg M, Leland NE, Davidson L, 
Mallinson T. Association of Length of Stay, Recovery Rate, and 
Therapy Time per Day With Functional Outcomes After Hip Fracture 
Surgery. JAMA Netw Open. 2020 Jan 3;3(1):e1919672. doi: 10.1001/
jamanetworkopen.2019.19672. PMID: 31977059; PMCID: PMC6991278.
    \59\ Chase, J.-A. D., Huang, L., Russell, D., Hanlon, A., 
O'Connor, M., Robinson, K.M., & Bowles, K.H. (2018). Racial/ethnic 
disparities in disability outcomes among post-acute home care 
patients. Journal of aging and health, 30(9), 1406-1426.
    \60\ Fashaw-Walters, S.A., Rahman, M., Gee, G., Mor, V., White, 
M., & Thomas, K.S. (2022). Out Of Reach: Inequities In The Use Of 
High-Quality Home Health Agencies: Study examines inequities in the 
use of high-quality home health agencies. Health Affairs, 41(2), 
247-255.
    \61\ Criss MG, Wingood M, Staples WH, Southard V, Miller KL, 
Norris TL, Avers D, Ciolek CH, Lewis CB, Strunk ER. APTA Geriatrics' 
Guiding Principles for Best Practices in Geriatric Physical Therapy: 
An Executive Summary. J Geriatr Phys Ther. 2022 Apr-June;45(2):70-
75. doi: 10.1519/JPT.0000000000000342. PMID: 35384940.
    \62\ Cogan AM, Weaver JA, McHarg M, Leland NE, Davidson L, 
Mallinson T. Association of Length of Stay, Recovery Rate, and 
Therapy Time per Day With Functional Outcomes After Hip Fracture 
Surgery. JAMA Netw Open. 2020 Jan 3;3(1):e1919672. doi: 10.1001/
jamanetworkopen.2019.19672. PMID: 31977059; PMCID: PMC6991278.
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    We are proposing to adopt the Discharge Function Score (DC 
Function) measure \63\ in the HH QRP beginning with the CY 2025 HHQRP. 
This assessment-based outcome measure evaluates functional status by 
calculating the percentage of HH patients who meet or exceed an 
expected discharge function score. We are proposing that this measure 
would replace the topped-out, cross-setting Application of Functional 
Assessment/Care Plan process measure. Like the cross-setting process 
measure it is replacing, the proposed measure is calculated using 
standardized patient assessment data from the current HH assessment 
tool.
---------------------------------------------------------------------------

    \63\ Discharge Function Score for Home Health Agencies (HHAs) 
Technical Report, which is available at https://www.cms.gov/files/document/hh-discharge-function-score-measure-technical-report.pdf.
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    In addition to meeting the requirements of the Act, the DC Function 
measure supports current CMS priorities. Specifically, the measure 
aligns with the Streamline Quality Measurement domain in CMS's 
Meaningful Measures 2.0 framework \64\ in two ways. First, the proposed 
outcome measure would further CMS's objective to increase the 
proportion of outcome measures in the HH QRP by replacing the 
Application of Functional Assessment/Care Plan cross-setting process 
measure with an outcome measure (see Section III.2 of this proposed 
rule). Second, this measure adds no additional provider burden since it 
would be calculated using data from the OASIS that are already reported 
to the Medicare program for payment and quality reporting purposes.
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    \64\ https://www.cms.gov/medicare/meaningful-measures-framework/meaningful-measures-20-moving-measure-reduction-modernization, 
accessed February 1, 2023.
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    The proposed DC Function measure would also follow a calculation 
approach similar to the existing functional outcome measures. 
Specifically, the measure (1) considers two dimensions of function 
(that is, self-care and mobility activities) and (2) accounts for 
missing data by using statistical imputation to improve the validity of 
measure performance. The statistical imputation recodes missing 
functional status data to a likely value had the status been assessed, 
whereas the current imputation approach implemented in existing 
function outcome measures recodes missing data to the lowest functional 
status.
(b) Measure Testing
    Measure testing was conducted on the DC Function measure to assess 
validity, reliability, and reportability, all of which informed 
stakeholder feedback and Technical Expert Panel (TEP) input (See the 
Stakeholder and Technical Expert Panel (TEP) Input section of this 
proposed rule). Validity was assessed for the measure performance, the 
risk adjustment model, face validity, and statistical imputation 
models. Validity testing of measure performance entailed determining 
Spearman's rank correlations between the proposed measure's performance 
and the performance of other publicly reported HH quality measures. 
Results indicated that the measure captures the most probable 
determination of actual outcomes based on the directionalities and 
strengths of correlation coefficients and are further detailed in Table 
C2.
[GRAPHIC] [TIFF OMITTED] TP10JY23.063

    Validity testing of the risk adjustment model showed good model 
discrimination, as the measure model has the predictive ability to 
distinguish patients with low expected functional capabilities from 
those with high expected functional capabilities.\65\ The ratios of 
observed-to-predicted discharge function score across eligible 
episodes, by deciles of expected functional capabilities, ranged from 
0.98 to 1.01. Both the Cross-Setting Discharge Function TEPs and 
patient-family feedback showed strong support for the face validity and 
importance of the proposed measure as an indicator of quality of care. 
Lastly, validity testing of the measure's statistical imputation models 
indicated that the models demonstrate good discrimination and produce 
more precise and accurate estimates of function scores for items with 
missing scores when compared to adopting the current imputation 
approach implemented in the SNF QRP functional outcome measures, 
specifically Change in Self-Care Score measure, Change in Mobility 
Score measure, Application of IRF Functional Outcome Measure: Discharge 
Self-Care Score for Medical Rehabilitation Patients (CBE ID #2635) 
(Discharge Self-Care Score) measure, and Application of IRF Functional 
Outcome Measure: Discharge Mobility Score for Medical Rehabilitation 
Patients (CBE ID #2636) (Discharge Mobility Score) measure. The current 
imputation approach involves recoding ``Activity Not Attempted'' (ANA) 
codes to ``1'' or ``most dependent.''
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    \65\ ``Expected functional capabilities'' is defined as the 
predicted discharge function score.

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[[Page 43728]]

    Reliability and reportability testing also yielded results that 
support the measure's scientific acceptability. Split-half testing 
revealed the proposed measure's excellent reliability, indicating an 
intraclass correlation coefficient value of 0.94. Reportability testing 
indicated good reportability (79 percent) of providers meeting the 
public reporting threshold of 20 eligible episodes. For additional 
measure testing details, we refer readers to the document titled 
Discharge Function Score for Home Health Agencies (HHAs) Technical 
Report, which is available at https://www.cms.gov/files/document/hh-discharge-function-score-measure-technical-report.pdf.
b. Competing and Related Measures
    Section 1899B(e)(2)(A) of the Act requires that, absent an 
exception under section 1899B(e)(2)(B) of the Act, measures specified 
under section 1899B of the Act be endorsed by the entity with a 
contract under section 1890(a). In the case of a specified area or 
medical topic determined appropriate by the Secretary for which a 
feasible and practical measure has not been endorsed, section 
1899B(e)(2)(B) permits the Secretary to specify a measure that is not 
so endorsed, as long as due consideration is given to measures that 
have been endorsed or adopted by a consensus organization identified by 
the Secretary.
    The proposed DC Function measure is not CBE-endorsed, so we 
considered whether there are other available measures that (1) assess 
both functional domains of self-care and mobility in HHs and (2) 
satisfy the requirement of the Act to develop and implement 
standardized quality measures from the quality measure domain of 
functional status, cognitive function, and changes in function and 
cognitive function across the PAC settings. While the Application of 
Functional Assessment/Care Plan measure assesses both functional 
domains and satisfies the Act's requirement, this cross-setting process 
measure is not CBE-endorsed and the performance on this measure among 
HHs is so high and unvarying across most providers that the measure 
does not offer meaningful distinctions in performance. Additionally, 
after review of the CBE's consensus-endorsed measures, we were unable 
to identify any CBE-endorsed measures for HHs that meet the 
aforementioned requirements.
    Therefore, after consideration of other available measures, we find 
that the exception under section 1899B(e)(2)(B) of the Act applies and 
are proposing to adopt the DC Function measure beginning with the CY 
2025 HH QRP. We intend to submit the proposed measure to the CBE for 
consideration of endorsement when feasible.
c. Interested Parties and Technical Expert Panel (TEP) Input
    In our development and specification of this measure, we employed a 
transparent process in which we sought input from stakeholders and 
national experts and engaged in a process that allowed for pre-
rulemaking input, in accordance with section 1890A of the Act. To meet 
this requirement, we provided the following opportunities for 
stakeholder input: a Patient and Family Engagement Listening Session, 
two TEPs, and public comments through a request for information (RFI).
    First, the measure development contractor convened a Patient and 
Family Engagement Listening Session, during which patients and 
caregivers provided views on the proposed measure concept. Participants 
expressed support and emphasized the importance of measuring functional 
outcomes and found self-care and mobility to be critical aspects of 
care. Additionally, they expressed a strong interest in metrics 
assessing the number of patients discharged from particular agencies or 
facilities with improvements in self-care and mobility, and their views 
of self-care and mobility aligned with the functional domains captured 
by the proposed measure. All feedback was used to inform measure 
development efforts.
    The measure development contractor subsequently convened TEPs on 
July 14-15, 2021 and January 26-27, 2022 to obtain expert input on the 
development of DC Function measure for use in the HH QRP. The TEPs 
consisted of stakeholders with a diverse range of expertise, including 
HH and PAC subject matter knowledge, clinical expertise, patient and 
family perspectives, and measure development experience. The TEPs 
supported the proposed measure concept and provided substantive 
feedback regarding the measure's specifications and measure testing 
data. First, the TEP was asked whether they prefer a cross-setting 
measure that is modeled after the Inpatient Rehabilitation Facility 
(IRF) Functional Outcome Measure: Discharge Mobility Score for Medical 
Rehabilitation Patients (CBE ID #2636) (Discharge Mobility Score) and 
IRF Functional Outcome Measure: Discharge Self-Care Score for Medical 
Rehabilitation Patients (CBE ID #2635) (Discharge Self-Care Score) 
measures, or one that is modeled after the IRF Functional Outcome 
Measure: Change in Mobility for Medical Rehabilitation Patients (CBE ID 
#2634) (Change in Mobility Score) and IRF Functional Outcome Measure: 
Change in Self-Care Score for Medical Rehabilitation Patients (CBE ID 
#2633) (Change in Self-Care Score). With the Discharge Mobility Score 
and Change in Mobility Score measures and the Discharge Self-Care Score 
and Change in Self-Care Score measures being both highly correlated and 
not appearing to measure unique concepts, the TEP favored the Discharge 
Mobility Score and Discharge Self-Care Score measures over the Change 
in Mobility Score and Change in Self-Care Score measures and 
recommended moving forward with the Discharge Mobility Score and 
Discharge Self-Care Score measures for the cross-setting measure. 
Second, in deciding on the standardized functional assessment data 
elements to include in the cross-setting measure, the TEP recommended 
removing redundant data elements. Strong correlations between scores of 
functional items within the same functional domain suggested that 
certain items may be redundant in eliciting information about patient 
function and inclusion of these items could lead to overrepresentation 
of a particular functional area. Subsequently, our measure development 
contractor focused on the Discharge Mobility Score measure as a 
starting point for cross-setting development due to the greater number 
of cross-setting standardized functional assessment data elements for 
mobility while also identifying redundant functional items that could 
be removed from a cross-setting functional measure.
    Additionally, the TEP supported including the cross-setting self-
care items such that the cross-setting function measure captures both 
self-care and mobility. Panelists agreed that self-care items added 
value to the measure and are clinically important to function. Lastly, 
the TEP provided refinements to imputation strategies to more 
accurately represent function performance across all PAC settings, 
including the support of using statistical imputation over the current 
imputation approach implemented in existing functional outcome measures 
in the PAC QRPs. We considered all the TEP's recommendations for 
developing a cross-setting function measure and applied those 
recommendations where technically feasible and appropriate. Summaries 
of the TEP proceedings titled Technical Expert Panel (TEP) for the 
Refinement of Long-Term Care Hospital (LTCH), Inpatient Rehabilitation 
Facility (IRF), Skilled

[[Page 43729]]

Nursing Facility (SNF)/Nursing Facility (NF), and Home Health (HH) 
Function Measures Summary Report (July 2021 TEP) available at https://mms-test.battelle.org/sites/default/files/TEP-Summary-Report-PAC-Function.pdf and Technical Expert Panel (TEP) for Cross-Setting 
Function Measure Development Summary Report (January 2022 TEP) 
available at https://mms-test.battelle.org/sites/default/files/PAC-Function-TEP-Summary-Report-Jan2022-508.pdf.
d. Measure Application Partnership (MAP) Review
    Our pre-rulemaking process includes making publicly available a 
list of quality and efficiency measures, called the MUC List, that the 
Secretary is considering adopting through the Federal rulemaking 
process for use in Medicare programs. This allows multi-stakeholder 
groups to provide recommendations to the Secretary on the measures 
included on the list.
    We included the DC Function measure under the HH QRP in the 
publicly available MUC List for December 1, 2022,\66\ and the CBE 
received five comments by industry interested parties on the 2022 MUC 
List. Three commenters were supportive of the measure and two were not. 
Among the commenters in support of the measure, one commenter stated 
that function scores are the most meaningful outcome measure in the HH 
setting, as they not only assess patient outcomes but also can be used 
for clinical improvement processes. Additionally, the commenter noted 
the measure's good reliability and validity and that the measure is 
feasible to implement. The second commenter supported the measure; 
however, the comments did not appear to be directly related to any 
aspect of the measure itself. The third commenter supported the measure 
without providing additional detailed comments.
---------------------------------------------------------------------------

    \66\ Centers for Medicare & Medicaid Services. Overview of the 
List of Measures Under Consideration for December 1, 2022. https://mmshub.cms.gov/sites/default/files/2022-MUC-List-Overview.pdf.
---------------------------------------------------------------------------

    Among the two commenters who did not support the DC Function 
measure, one commenter raised the following concerns: the 
``gameability'' of the expected discharge score, the measure's 
complexity, and the difficulty of implementing a composite functional 
score. CMS was able to address these concerns during the MAP PAC/LTC 
Workgroup Meeting held on December 12, 2022. Specifically, CMS 
clarified that the expected discharge scores are not calculated using 
self-reported functional goals and are simply calculated by risk-
adjusting the observed discharge scores (see the Quality Measure 
Calculation section III.C.1.e of this proposed rule). Therefore, CMS 
believes that these scores cannot be ``gamed'' by reporting less-
ambitious functional goals. CMS also pointed out that the measure is 
highly usable as it is similar in design and complexity to existing 
function measures (for example, Discharge Mobility Score and Discharge 
Self-Care Score for IRF) and that the data elements used in this 
measure are already in use.
    The other commenter who did not support the DC Function measure 
raised the following concerns: its performance for stabilization 
patients and its ability to account for patients that change payer 
during a HH episode. CMS was able to address the first concern during 
the MAP PAC/LTC Workgroup Meeting held on December 12, 2022. 
Specifically, CMS clarified that an episode will contribute to the 
numerator of DC Function if the observed discharge score meets or 
exceeds the expected discharge score, a value determined using clinical 
comorbidity and setting-specific parameters at the start or resumption 
of care. These parameters can and do predict no improvement among 
stabilization patients, that is, the expected discharge score can and 
does occasionally equal the observed admission score if clinical 
comorbidity and setting-specific parameters indicate no expected 
improvement in the risk adjustment model.
    The second concern was not raised during the MAP PAC/LTC Workgroup 
Meeting; however, we do not find any convincing evidence that it 
influences HHA-level performance for the majority of HHAs. Payer 
changes will only affect episodes ending between December 31 and March 
31. By comparing HHA-level performance calculated using the full 
calendar year versus using a dataset that excludes the dates with 
possibly affected episodes (January 1 through March 31 and December 
31), we assessed the degree to which this requirement influences 
performance. The Spearman correlation coefficient between the two 
scenarios is 0.97, and the changes in reliability and validity are 
smaller than one percentage point. The results imply that including or 
excluding affected episodes does not appear to influence HHA-level 
performance for the majority of HHAs. We will continue to monitor this 
concern in the future, and we will address it accordingly in the future 
if necessary.
    Shortly after, several CBE-convened MAP workgroups met virtually to 
provide input on the proposed DC Function measure. First, the MAP 
Health Equity workgroup convened on December 6-7, 2022. The workgroup 
did not share any health equity concerns related to the implementation 
of the DC Function measure, and only asked for clarification regarding 
measure specifications from measure developers. The MAP Rural Health 
workgroup met on December 8-9, 2022, during which two members provided 
support for the DC Function measure and other workgroup members did not 
express rural health concerns regarding the measure. The MAP Post-Acute 
Care/Long-Term Care (PAC-LTC) workgroup met virtually on December 12, 
2022 and provided input on the proposed DC Function measure. The 
workgroup voted to support the staff recommendation of conditional 
support for rulemaking.
    In response to the MAP PAC/LTC Workgroup's preliminary 
recommendation, the CBE received one comment in support and one comment 
not in support of the DC Function measure. The commenter in support of 
the DC Function measure supported the measure under the condition that 
it be reviewed and refined such that its implementation supports 
patient autonomy and results in care that aligns with patients' 
personal functional goals. The commenter who did not support the DC 
Function measure raised concern with the applicability of the DC 
Function measure considering the different patient populations served 
by the various PAC settings. CMS clarified that the DC Function measure 
is not designed to compare function across PAC settings, and that this 
feature is not a requirement of the IMPACT Act.
    Finally, the MAP Coordinating Committee convened on January 24-25, 
2023, during which the CBE received no comment on the PAC/LTC 
workgroup's preliminary recommendation for conditional support of the 
DC Function measure. The MAP Coordinating Committee upheld the PAC/LTC 
workgroup's recommendation of conditional support for rulemaking with 
20 votes in support and one against. We refer readers to the final MAP 
recommendations, titled 2022-2023 MAP Final Recommendations available 
at https://mmshub.cms.gov/measure-lifecycle/measure-implementation/pre-rulemaking/lists-and-reports.
e. Quality Measure Calculation
    The proposed outcome measure estimates the percentage of HH 
patients who meet or exceed an expected

[[Page 43730]]

discharge score during the reporting period. The proposed measure's 
numerator is the number of HH episodes with an observed discharge 
function score that is equal to or higher than the calculated expected 
discharge function score. The observed discharge function score is the 
sum of individual function items at discharge. The expected discharge 
function score is computed by risk adjusting the observed discharge 
function score for each HH episode. Risk adjustment controls for 
patient characteristics such as admission function score, age, and 
clinical conditions. The denominator is the total number of HH episodes 
in the measure target period (four rolling quarters) that do not meet 
the measure exclusion criteria. For additional details regarding the 
numerator, denominator, risk adjustment, and exclusion criteria, refer 
to the Discharge Function Score for Home Health Agencies (HHAs) 
Technical Report available at https://www.cms.gov/files/document/hh-discharge-function-score-measure-technical-report.pdf.
    The proposed measure implements a statistical imputation approach 
for handling ``missing'' standardized functional assessment data 
elements. The coding guidance for standardized functional assessment 
data elements allows for using ANA codes, resulting in ``missing'' 
information about a patient's functional ability on at least some 
items, at admission and/or discharge, for a substantive portion of HH 
patients. Statistical imputation replaces these missing values with a 
variable based on the values of other, non-missing variables in the 
data and which are otherwise similar to the assessment with a missing 
value. Specifically, in this proposed DC Function measure statistical 
imputation allows missing values (for example, the ANA codes) to be 
replaced with any value from 1 to 6, based on a patient's clinical 
characteristics and codes assigned on other standardized functional 
assessment data element. The measure implements separate imputation 
models for each standardized functional assessment data element used in 
measure construction at admission and discharge. Relative to the 
current simple imputation method, this statistical imputation approach 
increases precision and accuracy and reduces the bias in estimates of 
missing item scores. We refer readers to the Discharge Function Score 
for Home Health Agencies (HHAs) Technical Report available at https://www.cms.gov/files/document/hh-discharge-function-score-measure-technical-report.pdf for measure specifications and additional details 
on measure testing, including the method for comparing the statistical 
imputation approach to the current simple imputation method.
    We invite public comment on our proposal to adopt the DC Function 
measure, beginning with the CY 2025 HH QRP.
2. Proposed Removal of the ``Application of Percent of Long-Term Care 
Hospital Patients With an Admission and Discharge Functional Assessment 
and a Care Plan That Addresses Function'' Beginning With the CY 2025 HH 
QRP
    We are proposing to remove the ``Application of Percent of Long-
Term Care Hospital Patients with an Admission and Discharge Functional 
Assessment and a Care Plan That Addresses Function'' (Application of 
Functional Assessment/Care Plan) measure from the HH QRP beginning with 
the CY 2025 HH QRP. Section 42 CFR 484.245(b)(3) of our regulations 
specifies eight factors we consider for measure removal from the HH 
QRP, and we believe this measure should be removed because it satisfies 
two of these factors.
    First, the Application of Functional Assessment/Care Plan measure 
meets the conditions for measure removal factor one: measure 
performance among HHAs is so high and unvarying that meaningful 
distinctions in improvements in performance can no longer be made.\67\ 
Second, this measure meets the conditions for measure removal factor 
six: there is an available measure that is more strongly associated 
with desired patient functional outcomes. We believe the proposed DC 
function measure discussed in section XX of this proposed rule better 
measures functional outcomes than the current Application of Functional 
Assessment/Care Plan measure. We discuss each of these reasons in more 
detail later in this proposed rule.
---------------------------------------------------------------------------

    \67\ For more information on the factors the Centers for 
Medicare & Medicaid Services (CMS) uses to base decisions for 
measure removal, we refer readers to the Code of Federal 
Regulations, Sec.  484.245(b)(3) https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-484/subpart-E/section-484.245.
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    In regards to removal factor one, the Application of Functional 
Assessment/Care Plan measure has become topped out, with average 
performance rates reaching nearly 100 percent over the past 3 years 
(ranging from 96-98 percent during calendar years (CYs) 2019-2021).\68\ 
For the 12-month period of third quarter of CY 2021, HHAs had an 
average score for this measure of 98 percent, with nearly 75 percent of 
HHAs scoring 100 percent. The proximity of these mean rates to the 
maximum score of 100 percent suggests a ceiling effect and a lack of 
variation that restricts distinction among HHAs.
---------------------------------------------------------------------------

    \68\ CMS. Home Health Agency Data Archive, 2019--2021, Annual 
Files National Data. PDC, https://data.cms.gov/provider-data/archived-data/home-health-services.
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    In regards to measure removal factor six, the DC Function measure 
is more strongly associated with desired patient functional outcomes 
than this current process measure, the Application of Functional 
Assessment/Care Plan measure. As described in section IIII.C.1 of this 
proposed rule, the DC Function measure has the predictive ability to 
distinguish patients with low expected functional capabilities from 
those with high expected functional capabilities.\69\ We have been 
collecting standardized functional assessment elements across PAC 
settings since 2016 which has allowed for the development of the 
proposed DC Function measure and meets the statutory requirements to 
submit standardized patient assessment data and other necessary data 
with respect to the domain of functional status, cognitive function, 
and changes in function and cognitive function. In light of this 
development, this process measure, the Application of Functional 
Assessment/Care Plan measure which measures only whether a functional 
assessment is completed and a functional goal is included in the care 
plan, is no longer necessary, and can be replaced with a measure that 
evaluates the HHA's outcome of care on a patient's function.
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    \69\ ``Expected functional capabilities'' is defined as the 
predicted discharge function score.
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    Because the Application of Functional Assessment/Care Plan measure 
meets measure removal factors one and six, we are proposing to remove 
it from the HH QRP beginning with the CY 2025 HH QRP. We are also 
proposing that public reporting of the Application of Functional 
Assessment/Care Plan measure would end by January 2025 or as soon as 
technically feasible when public reporting of the proposed DC Function 
measure would begin (see section III.F.2. of this proposed rule).
    Under our proposal, HHAs would no longer be required to report a 
Self-Care Discharge Goal (that is, GG0130, Column 2) or a Mobility 
Discharge Goals (that is, GG0170, Column 2) on the OASIS beginning with 
patients admitted on April 1, 2024. We would remove the items for Self-
Care Discharge Goals (that is, GG0130, Column 2) and Mobility Discharge 
Goals (that is, GG0170,

[[Page 43731]]

Column 2) with the next release of the OASIS. Under our proposal, these 
items would not be required to meet HH QRP requirements beginning with 
the CY 2025 HH QRP.
    We invite public comment on our proposal to remove the Application 
of Functional Assessment/Care Plan measure from the HH QRP beginning 
with the CY 2025 HH QRP.
3. COVID-19 Vaccine: Percent of Patients/Residents Who Are Up to Date 
Beginning With the CY 2025 HH QRP
a. Background
    COVID-19 has been and continues to be a major challenge for PAC 
facilities, including HHAs. The Secretary first declared COVID-19 a PHE 
on January 31, 2020. As of March 15, 2023, the U.S. has reported 
103,801,821 cumulative cases of COVID-19, and 1,121,512 total deaths 
due to COVID-19.\70\ Although all age groups are at risk of contracting 
COVID-19, older persons are at a significantly higher risk of mortality 
and severe disease following infection, with those over age 80 dying at 
five times the average rate.\71\ Older adults, in general, are prone to 
both acute and chronic infections owing to reduced immunity, and are a 
high-risk population.\72\ Adults age 65 and older comprise over 75% of 
total COVID-19 deaths despite representing 13.4% of reported cases.\73\ 
Restrictions on freedom of movement and physical distancing can lead to 
a disruption of essential care and support for older persons. Physical 
distancing measures that restrict visitors and group activities can 
negatively affect the physical and mental health and well-being of 
older persons, particularly those with cognitive decline or dementia, 
and who are highly care-dependent.\74\
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    \70\ Centers for Disease Control and Prevention. COVID Data 
Tracker. 2023, January 20. Last accessed March 23, 2023. https://covid.cdc.gov/covid-data-tracker/#cases_totalcases.
    \71\ United Nations. Policy Brief: The impact of COVID-19 on 
older persons. May 2020. https://unsdg.un.org/sites/default/files/2020-05/Policy-Brief-The-Impact-of-COVID-19-on-Older-Persons.pdf.
    \72\ Lekamwasam R, Lekamwasam S. Effects of COVID-19 pandemic on 
health and wellbeing of older people: a comprehensive review. Ann 
Geriatr Med Res. 2020;24(3):166-172. http://dx.doi.org/10.4235/agmr.20.0027. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7533189/.
    \73\ Centers for Disease Control and Prevention. Demographic 
trends of COVID-19 cases and deaths in the US reported to CDC. COVID 
Data Tracker. 2023, March 15. Last accessed March 23, 2023. https://covid.cdc.gov/covid-data-tracker/#demographics.
    \74\ United Nations. Policy Brief: The impact of COVID-19 on 
older persons. May 2020. https://unsdg.un.org/sites/default/files/2020-05/Policy-Brief-The-Impact-of-COVID-19-on-Older-Persons.pdf.
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    Since the development of the vaccines to combat COVID-19, studies 
have shown that being up to date on these vaccines continues to provide 
strong protection against severe disease, hospitalization, and death in 
adults, including during the predominance of Omicron BA.4 and BA.5 
variants.\75\ Initial studies showed the efficacy of FDA-approved 
COVID-19 vaccines in reducing the risk of severe outcomes caused by 
COVID-19. Further, residents at skilled nursing facilities (SNF) with 
high rates of staff testing for COVID-19 were less likely to be 
hospitalized or die due to COVID-19 than their counterparts in SNFs 
with low rates of staff testing. Prior to the emergence of the Delta 
variant of the virus, vaccine effectiveness against COVID-19-associated 
hospitalization among adults age 65 and older was 91% for those 
receiving a full mRNA vaccination (Pfizer-BioNTech or Moderna), and 84% 
for those receiving a viral vector vaccination (Janssen). Adults age 65 
and older who were fully vaccinated with an mRNA COVID-19 vaccine had a 
94% reduction in risk of COVID-19 hospitalization; those who were 
partially vaccinated had a 64% reduction in risk.\76\ Further, after 
the emergence of the Delta variant, vaccine effectiveness against 
COVID-19-associated hospitalization for adults who received the primary 
series of the vaccine was 76% among adults age 75 and older.\77\
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    \75\ Chalkias S, Harper C, Vrbicky K, et al. A bivalent omicron-
containing booster vaccine against COVID-19. N Engl J Med. 
2022;387(14):1279-1291. doi: 10.0156/NEJMoa2208343. https://www.nejm.org/doi/full/10.1056/NEJMoa2208343.
    \76\ Centers for Disease Control and Prevention. Press Release, 
April 28, 2021. Fully Vaccinated Adults 65 and Older are 94% Less 
Likely to Be Hospitalized with COID-19. https://www.cdc.gov/media/releases/2021/p0428-vaccinated-adults-less-hospitalized.html.
    \77\ Vaccine effectiveness after the emergence of the Delta 
variant is based on data from CDC's VISION Network, which examined 
32,867 medical encounters from 187 hospitals and 221 emergency 
departments and urgent care clinics across nine states during June-
August 2021, beginning on the date the Delta variant accounted for 
over 50% of sequenced isolates in each medical facility's state 
(Grannis SJ, et al. MMWR Morb Mortal Wkly Rep. 2021;70(37):1291-
1293. doi: http://dx.doi.org/10.15585/mmwr.mm7037e2).
---------------------------------------------------------------------------

    More recently, since the emergence of the Omicron variants and 
availability of booster doses, multiple studies have shown that while 
vaccine effectiveness against infection has waned, protection is higher 
among those receiving booster doses than among those only receiving the 
primary series.78 79 80 CDC data show that, among people age 
50 and older, those who have received both a primary vaccination series 
and booster shots have a lower risk of hospitalization and dying from 
COVID-19 than their non-vaccinated counterparts.\81\ Additionally, a 
second vaccine booster has been shown to be effective against severe 
outcomes related to COVID-19, such as hospitalization or death.\82\ 
Furthermore, more recent vaccination and booster doses can decrease the 
rate of COVID-19 transmission between individuals in close contact.\83\ 
Early evidence also demonstrates that the bivalent booster, 
specifically aimed to combat the prevalent BA.4/BA.5 Omicron 
subvariants, provokes a superior antibody response against Omicron than 
the initial COVID-19 vaccines, underscoring, the role of up-to-date 
vaccination protocols in effectively countering the spread of COVID-
19.\84\
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    \78\ Surie D, Bonnell L, Adams K, et al. Effectiveness of 
monovalent mRNA vaccines against COVID-19-associated hospitalization 
among immunocompetent adults during BA.1/BA.2 and BA.4/BA.5 
predominant periods of SARS-CoV-2 Omicron variant in the United 
States -- IVY Network, 18 states, December 26, 2021-August 31, 2022. 
MMWR Morb Mortal Wkly Rep. 2022;71(42):1327-1334. http://dx.doi.org/10.15585/mmwr.mm7142a3.
    \79\ Andrews N, Stowe J, Kirsebom F, et al. Covid-19 vaccine 
effectiveness against the Omicron (B.1.1.529) variant. N Engl J Med. 
2022;386(16):1532-1546. https://www.nejm.org/doi/full/10.1056/NEJMoa2119451.
    \80\ Buchan SA, Chung H, Brown KA, et al. Estimated 
effectiveness of COVID-19 vaccines against Omicron or Delta 
symptomatic infection and severe outcomes. JAMA Netw Open. 
2022;5(9):e2232760. http://dx.doi.org/10.1001/jamanetworkopen.2022.32760. https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2796615.
    \81\ Centers for Disease Control and Prevention. Daily update 
for the United States. COVID Data Tracker. 2023, January 20. Last 
accessed January 17, 2023. https://covid.cdc.gov/covid-data-tracker.
    \82\ Centers for Disease Control and Prevention. COVID-19 
vaccine effectiveness monthly update. COVID Data Tracker. March 23, 
2023. https://covid.cdc.gov/covid-data-tracker/#vaccine-effectiveness.
    \83\ Tan ST., Kwan AT, Rodriguez-Barraquer I, et al. 
Infectiousness of SARS-CoV-2 breakthrough infections and 
reinfections during the Omicron wave. Preprint at medRxiv:
    \84\ Chalkias S, Harper C, Vrbicky K, et al. A bivalent Omicron-
containing booster vaccine against COVID-19. N Engl J 
Med2022;387(14):1279-1291. doi: 10.0156/NEJMoa2208343. https://www.nejm.org/doi/full/10.1056/NEJMoa2208343.
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(1) Measure Importance
    Despite the availability and demonstrated effectiveness of COVID-19 
vaccinations, significant gaps continue to exist in vaccination 
rates.\85\ As of March 15, 2023, vaccination rates among people age 65 
and older are generally high for the primary vaccination series (94.3%) 
but lower for

[[Page 43732]]

the first booster (73.6%) among those who received a primary series) 
and even lower for the second booster (59.9%) among those who received 
a first booster).\86\ Additionally, though the uptake in boosters among 
people age 65 and older has been much higher than among people of other 
ages, booster uptake still remains relatively low compared to primary 
vaccination among older adults.\87\ Variations are also present when 
examining vaccination rates by race, gender, and geographic 
location.\88\ For example, 66.2% of the Asian, non-Hispanic population 
have completed the primary series and 21.2% have received the bivalent 
booster dose, whereas 44.9% of the Black, non-Hispanic population have 
completed the primary series and only 8.9% have received the bivalent 
booster dose. Among Hispanic populations, 57.1% of the population have 
completed the primary series, with 8.5% receiving the bivalent booster 
dose, while in White, non-Hispanic populations, 51.9% have completed 
the primary series and 16.2% have received the bivalent booster 
dose.\89\ Disparities have been found in vaccination rates between 
rural and urban areas, with lower vaccination rates found in rural 
areas.90 91 Data show that 55.1% of the population in rural 
areas have completed the primary vaccination series, as compared to 
66.2% of the population in urban areas.\92\ Receipt of first booster 
doses was similar between urban (50.4%) and rural (49.7%) counties.\93\ 
Receipt of bivalent booster doses has been lower, with 16.9% of urban 
population having received the booster dose, and 10.9% of the rural 
population having received the booster dose.\94\
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    \85\ Centers for Disease Control and Prevention. COVID-19 
vaccinations in the United States. COVID Data Tracker. March 23, 
2023. https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-people-booster-percent-pop5.
    \86\ Centers for Disease Control and Prevention. COVID-19 
vaccination age and sex trends in the United States, national and 
jurisdictional. Last accessed March 24, 2023. Vaccination Trends.
    \87\ Freed M, Neuman T, Kates J, Cubanski J. Deaths among older 
adults due to COVID-19 jumped during the summer of 2022 before 
falling somewhat in September. Kaiser Family Foundation. October 6, 
2022. https://www.kff.org/coronavirus-covid-19/issue-brief/deaths-among-older-adults-due-to-covid-19-jumped-during-the-summer-of-2022-before-falling-somewhat-in-september/.
    \88\ Saelee R, Zell E, Murthy BP, et al. Disparities in COVID-19 
vaccination coverage between urban and rural counties--United 
States, December 14, 2020-January 31, 2022. MMWR Morb Mortal Wkly 
Rep. 2022;71:335-340. http://dx.doi.org/10.15585/mmwr.mm7109a2.
    \89\ Centers for Disease Control and Prevention. Trends in 
Demographic Characteristics of People Receiving COVID-19 
Vaccinations in the United States. COVID Data Tracker. 2023, January 
20. Last accessed March 23, 2023. https://covid.cdc.gov/covid-data-tracker/#vaccination-demographics-trends.
    \90\ Saelee R, Zell E, Murthy BP, et al. Disparities in COVID-19 
vaccination coverage between urban and rural counties--United 
States, December 14, 2020-January 31, 2022. MMWR Morb Mortal Wkly 
Rep. 2022;71:335-340. DOI: http://dx.doi.org/10.15585/mmwr.mm7109a2.
    \91\ Sun Y, Monnat SM. Rural-urban and within-rural differences 
in COVID-19 vaccination rates. J Rural Health. 2022;38(4):916-922. 
http://dx.doi.org/10.1111/jrh.12625. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8661570/.
    \92\ Centers for Disease Control and Prevention. Vaccination 
Equity. COVID Data Tracker; 2023, January 20. Last accessed January 
17, 2023. https://covid.cdc.gov/covid-data-tracker/#vaccination-equity.
    \93\ Saelee R, Zell E, Murthy BP, et al. Disparities in COVID-19 
vaccination coverage between urban and rural counties--United 
States, December 14, 2020-January 31, 2022. MMWR Morb Mortal Wkly 
Rep. 2022;71:335-340. http://dx.doi.org/10.15585/mmwr.mm7109a2.
    \94\ Centers for Disease Control and Prevention. Vaccination 
Equity. COVID Data Tracker; 2023, January 20. Last accessed January 
17, 2023. https://covid.cdc.gov/covid-data-tracker/#vaccination-equity.
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    We are proposing to adopt the COVID-19 Vaccine: Percent of 
Patients/Residents who are Up to Date (Patient/Resident COVID-19 
Vaccine) measure for the HH QRP beginning with the CY 2025 HH QRP. This 
proposed measure has the potential to increase COVID-19 vaccination 
coverage of patients in HHAs. This proposed measure also has the 
potential to prevent the spread of the virus within the HHA patient 
population. Although this population receives services within their own 
homes, they can transfer the virus to their caretakers and home 
healthcare workers, who could then potentially infect other home health 
patients. The proposed Patient/Resident COVID-19 Vaccine measure would 
also support the goal of the CMS Meaningful Measure Initiative 2.0 to 
``Empower consumers to make good health care choices through patient-
directed quality measures and public transparency objectives.'' The 
Patient/Resident COVID-19 Vaccine measure would be reported on Care 
Compare and would provide patients, including those who are at high 
risk for developing serious complications from COVID-19, and their 
caregivers, with valuable information they can consider when choosing a 
HHA. The proposed Patient/Resident COVID-19 vaccine measure would also 
facilitate patient care and care coordination during the hospital 
discharge planning process. For example, a discharging hospital, in 
collaboration with the patient and family, could use this measure to 
coordinate care and ensure patient preferences are considered in the 
discharge plan. Additionally, the proposed Patient/Resident COVID-19 
Vaccine measure would be an indirect measure of HHA action. Since the 
patient's COVID-19 vaccination status would be reported at discharge 
from the HHA, if a patient is not up to date with their COVID-19 
vaccination per applicable CDC guidance at the time they are admitted, 
the HHA has the opportunity to educate the patient and provide 
information on why they should become up to date with their COVID-19 
vaccination. HHAs may also choose to administer the vaccine to the 
patient prior to their discharge from the HHA or coordinate a follow up 
visit for the patient to obtain the vaccine at their physician's office 
or local pharmacy.
(2) Item Testing
    Item testing was conducted for the proposed Patient/Resident COVID-
19 Vaccine measure using patient scenarios and cognitive interviews to 
assess HHA providers' comprehension of the item and the associated 
guidance. The patient scenarios were developed in collaboration with a 
team of clinical experts and represented the most common scenarios HHA 
providers encounter. The results of the item testing supported its 
reliability, and provided information to improve the item itself, as 
well as the accompanying guidance.
b. Competing and Related Measures
    Section 1899B(e)(2)(A) of the Act requires that, absent an 
exception under section 1899B(e)(2)(B) of the Act, each measure 
specified under section 1899B of the Act be endorsed by the entity with 
a contract under section 1890(a) of the Act. In the case of a specified 
area or medical topic determined appropriate by the Secretary for which 
a feasible and practical measure has not been endorsed, section 
1899B(e)(2)(B) of the Act permits the Secretary to specify a measure 
that is not so endorsed, as long as due consideration is given to the 
measures that have been endorsed or adopted by a consensus organization 
identified by the Secretary.
    The proposed Patient/Resident COVID-19 Vaccine measure is not 
consensus-based entity (CBE) endorsed. After review of other CBE 
endorsed measures, we were unable to identify any CBE endorsed measures 
for HHAs focused on capturing COVID-19 vaccination coverage of HHA 
patients, and found no related measures in the HH QRP addressing COVID-
19 vaccination. There have been COVID-19 Vaccination Coverage among 
Healthcare Personnel (HCP) measures adopted by the Skilled Nursing 
Facility (SNF) QRP, the Intermediate Rehabilitation Facility (QRP) and 
the Long-term Care Hospital (LTCH) QRP that captures the percentage of 
HCPs who receive a complete COVID-19 vaccination course. We also 
identified Nursing Home (NH) COVID-19 vaccine rates posted on Care 
Compare. However, these data are

[[Page 43733]]

obtained from CDC's NHSN and report rates of vaccination for the NH 
resident population. HHAs do not report patient/resident or HCP COVID-
19 vaccination to the NHSN.
    Therefore, after consideration of other available measures that 
assess COVID-19 vaccination rates, we believe the exception under 
section 1899B(e)(2)(B) of the Act applies. We intend to submit the 
measure for CBE endorsement when feasible.
c. Interested Parties and Technical Expert Panel (TEP) Input
    In the development and specification of this measure, a transparent 
process was employed to seek input from interested parties and national 
experts and engage in a process that allows for pre-rulemaking input in 
accordance with section 1890A of the Act. First, the measure 
development contractor convened a focus group of patient and family/
caregiver advocates (PFAs) to solicit input. The PFAs felt a measure 
capturing raw vaccination rate, irrespective of HHA action, would be 
most helpful in patient and family/caregiver decision-making. Next, TEP 
meetings were held on November 19, 2021 and December 15, 2021 to 
solicit feedback on the development of Patient/Resident COVID-19 
vaccination measures and assessment items for the PAC settings. The TEP 
panelists voiced their support for PAC Patient/Resident COVID-19 
vaccination measures and agreed that developing a measure to report the 
rate of vaccination in an HHA setting without denominator exclusions 
was an important goal. All recommendations from the TEP were taken into 
consideration and applied appropriately where technically feasible and 
appropriate. A summary of the TEP proceedings titled Technical Expert 
Panel (TEP) for the Development of Long-Term Care Hospital (LTCH), 
Inpatient Rehabilitation Facility (IRF), Skilled Nursing Facility 
(SNF)/Nursing Facility (NF), and Home Health (HH) COVID-19 Vaccination-
Related Items and Measures Summary Report is available on the CMS 
Measures Management System (MMS) Hub. at https://mmshub.cms.gov/sites/default/files/COVID19-Patient-Level-Vaccination-TEP-Summary-Report-NovDec2021.pdf.
d. Measures Applications Partnership Review
    The pre-rulemaking process includes making publicly available a 
list of quality and efficiency measures, called the Measures Under 
Consideration (MUC) List that the Secretary is considering adopting, 
through Federal rulemaking process, for use in Medicare programs. This 
allows interested parties to provide recommendations to the Secretary 
on the measures included on the list. The Patient/Resident COVID-19 
Vaccine measure was included on the publicly available 2022 MUC List 
for the HH QRP.\95\ Shortly after, several CBE-convened MAP workgroups 
met virtually to provide input on the proposed measure. First, the MAP 
Health Equity advisory group convened on December 6, 2022. One MAP 
member noted that the percentage of true contraindications for the 
COVID-19 vaccine is low, and the lack of exclusions on the measure 
makes sense to avoid varying interpretations of valid 
contraindications.\96\ Similarly, the MAP Rural Health advisory group 
met on December 8, 2022 and publicly stated that the measure is 
important for rural communities.\97\
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    \95\ CMS Measures Management System (MMS). Measure 
Implementation: Pre-rulemaking MUC Lists and MAP reports. Last 
accessed March 23, 2023 https://mmshub.cms.gov/measure-lifecycle/measure-implementation/pre-rulemaking/lists-and-reports.
    \96\ National Quality Forum MAP Health Equity Advisory Group 
Materials. Meeting Summary--MUC Review Meeting. Last accessed March 
23, 2023. https://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=97943.
    \97\ National Quality Forum MAP Rural Health Advisory Group 
Materials. Meeting Summary--MUC Review Meeting. Last accessed March 
23, 2023. https://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=97964.
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    Prior to convening the MAP PAC/LTC workgroup, the CBE received 
seven comments by industry interested parties during the proposed 
measure's MAP pre-rulemaking process. Interested parties were mostly 
supportive of the measure and recognized that it is important that 
patients be vaccinated against COVID-19, and that measurement and 
reporting is one important method to help healthcare organizations 
assess their performance in achieving high rates of ``up-to-date'' 
vaccination. One interested party noted that patient engagement is 
critical at this stage of the pandemic because best available 
information indicates COVID-19 variants will continue to require 
additional boosters to avert case surges. Another interested party 
noted the benefit of less-specific criteria for inclusion in the 
numerator and denominator of the proposed Patient/Resident COVID-19 
Vaccine measure, which would provide flexibility for the measure to 
remain relevant to current circumstances. Other interested parties 
raised concerns about the proposed measure not including measuring the 
HHA's action in the numerator and excluding patient refusals from the 
denominator, and noted that there could be unintended consequences to 
patient access to care should the measure be adopted.
    Subsequently, the MAP Post-Acute Care/Long-Term Care (PAC/LTC) 
workgroup met on December 12, 2022. The voting workgroup members noted 
the importance of reporting patients' vaccination status but raised 
concerns that (1) the proposed Patient/Resident COVID-19 Vaccine 
measure does not account for patient refusals or those who are unable 
to respond, and (2) the difficulty of implementing ``up to date.'' CMS 
clarified during the MAP PAC/LTC workgroup that the proposed Patient/
Resident COVID-19 Vaccine measure does not have exclusions for patient 
refusals because the proposed measure was intended to report raw rates 
of vaccination and this information is important for consumer choice. 
Additionally, CMS believes that PAC providers, including HHAs, are in a 
unique position to leverage their care processes to increase 
vaccination coverage in their settings to protect patients and prevent 
negative outcomes. CMS also clarified that the measure defines ``up to 
date'' in a manner that provides flexibility to reflect future changes 
in CDC guidance. However, the MAP PAC/LTC workgroup reached a 60 
percent consensus on the vote of ``Do not support for rulemaking'' for 
this measure.\98\
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    \98\ National Quality Forum MAP Post-Acute Care/Long Term Care 
Workgroup Materials. Meeting Summary--MUC Review Meeting. Last 
accessed March 23, 2023. https://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=97960.
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    The MAP received 10 comments by interested parties in response to 
the MAP PAC/LTC workgroup recommendations. Interested parties generally 
understood the importance of COVID-19 vaccinations in preventing the 
spread of COVID-19 infections, however, a majority of commenters did 
not recommend the inclusion of this measure for HH QRP and raised 
several concerns. Specifically, several commenters were concerned about 
vaccine hesitancy, HHAs' inability to influence measure results based 
on factors outside of their control. Commenters also noted that the 
proposed Patient/Resident COVID-19 Vaccine measure has not been fully 
tested, and encouraged CMS to monitor the measure for unintended 
consequences and ensure that the measure has meaningful results. One 
commenter was in support of the proposed Patient/Resident COVID-19 
Vaccine measure and provided recommendations for CMS to consider. 
including an exclusion for medical

[[Page 43734]]

contraindications and submitting the measure for CBE endorsement.
    Finally, the MAP Coordinating Committee convened on January 24, 
2023, and raised concerns which were previously discussed in the PAC/
LTC workgroup, such as potential for selection bias based on the 
patient's vaccination status. CMS noted that this measure does not have 
exclusions for patient refusals since this is a process measure 
intended to report raw rates of vaccination, and is not intended to be 
an HHA action measure. CMS acknowledged that a measure accounting for 
variables (such as HHA actions to vaccinate patients) could be 
important, but CMS is focused on a measure which would provide and 
publicly report vaccination rates for consumers given the importance of 
this information to patients and their caregivers.
    The MAP Coordinating Committee recommended three changes to make 
the Patient/Resident COVID-19 Vaccine measure acceptable to the 
Committee: (i) reconsider exclusions for medical contraindications, 
(ii) complete reliability and validity measure testing, and (iii) seek 
CBE endorsement. The MAP Coordinating Committee ultimately reached 
consensus on its voted recommendation of `Do not support with potential 
for mitigation.' We refer readers to the final MAP recommendations, 
titled 2022-2023 MAP Final Recommendations \99\ and the MAP Final 
Report.\100\ Despite the Coordinating Committee's vote, we believe it 
is still important to propose the Patient/Resident COVID-19 Vaccine 
measure for the HH QRP. As we stated in section III.C.3.e of this 
proposed rule, we did not include exclusions for medical 
contraindications because the PFAs we met with told us that a measure 
capturing raw vaccination rate, irrespective of any medical 
contraindications, would be most helpful in patient and family/
caregiver decision-making. We do plan to conduct reliability and 
validity measure testing once we have collected enough data, and we 
intend to submit the proposed measure to the CBE for consideration of 
endorsement when feasible.
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    \99\ 2022-2023 MAP Final Recommendations, can be found at 
https://www.qualityforum.org/map/.
    \100\ The Final MAP Report is available at https://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=98102.
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e. Quality Measure Calculation
    The proposed Patient/Resident COVID-19 Vaccine measure is an 
assessment-based process measure that reports the percent of home 
health patients that are up to date on their COVID-19 vaccinations per 
CDC's latest guidance.\101\ This measure has no exclusions, and is not 
risk adjusted.
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    \101\ The definition of ``up to date'' may change based on CDC's 
latest guidelines and can be found on the CDC web page, ``Stay Up to 
Date with COVID-19 Vaccines Including Boosters,'' at https://www.cdc.gov/coronavirus/2019-ncov/vaccines/stay-up-to-date.html 
(updated March 2, 2023).
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    The numerator for this proposed measure would be the total number 
of home health patients that are up to date with the COVID-19 vaccine 
during the reporting period. The denominator for the measure would be 
the total number of home health stays with an End of Care OASIS 
(Discharge, Transfer or Death at Home) during the reporting period.
    The data source for the proposed Patient/Resident COVID-19 Vaccine 
measure is the OASIS assessment instrument for home health patients. 
For more information about the proposed data submission requirements, 
we refer readers to section III.E.2 of this proposed rule. For 
additional technical information about this proposed measure, we refer 
readers to the draft measure specifications document titled Patient-
Resident-COVID-Vaccine-Draft-Specs.pdf available at: https://www.cms.gov/files/document/patient-covid-vaccine-measure-hh-qrp-specifications.pdf.
    We invite public comments on our proposal to adopt the COVID-19 
Vaccine: Percent of Patients/Residents Who Are Up to Date measure 
beginning with the CY 2025 HH QRP.

E. Form, Manner, and Timing of Data Submission Under the HH QRP

1. Proposed Schedule for Data Submission of the Discharge Function 
Score Measure Beginning With the FY 2025 LTCH QRP
    As discussed in section III.C.1. of the proposed rule, we are 
proposing to adopt the Discharge Function Score quality measure 
beginning with the CY 2025 HH QRP. If finalized as proposed, HHAs would 
be required to report these OASIS assessment data beginning with 
patients discharged between January 1, 2024 and March 31, 2024 for the 
CY 2025 HH QRP. Starting in CY 2024, HHAs would be required to submit 
data for the entire calendar year beginning with the CY 2026 HH QRP. 
Because the Discharge Function Score quality measure is calculated 
based on data that are currently submitted to the Medicare program, 
there would be no additional information collection required from HHAs.
    We invite public comments on this proposal to require HHAs to 
report OASIS assessment data for the Discharge Function Score quality 
measure beginning with patients discharged between January 1, 2024 and 
March 31, 2024 for the CY 2025 HH QRP.
2. Proposed Schedule for Data Submission of the COVID-19 Vaccine: 
Percent of Patients/Residents Who Are Up to Date Beginning With the CY 
2026 HH QRP
    As discussed in section III.C.3 of the proposed rule, we are 
proposing to adopt the COVID-19 Vaccine: Percent of Patients/Residents 
Who Are Up to Date quality measure beginning with the CY 2025HH QRP. If 
finalized as proposed, HHAs would be required to report these OASIS 
assessment data beginning with patients discharged between January 1, 
2025 and March 31, 2025 for the CY 2025 HH QRP. Starting in CY 2025, 
HHAs would be required to submit data for the entire calendar year 
beginning with the CY 2026 HH QRP.
    If finalized as proposed, we would revise the OASIS in order for 
HHAs to submit data pursuant to this finalized policy. A new item would 
be added to the current item set to collect information on whether a 
patient is up to date with their COVID-19 vaccine at the time of 
discharge from the HHA. A draft of the new item is available in the 
COVID-19 Vaccine: Percent of Patients/Residents Who Are Up to Date 
Draft Measure Specifications at https://www.cms.gov/files/document/patient-covid-vaccine-measure-hh-qrp-specifications.pdf.
    We invite public comments on this proposal to require HHAs to 
report OASIS assessment data for the COVID-19 Vaccine: Percent of 
Patients/Residents Who Are Up to Date quality measure. HHAs would be 
required to submit data beginning with patients discharged between 
January 1, 2025 and March 31, 2025 for public reporting of this QM in 
the CY 2025 HH QRP.
3. Data Elements Proposed for Removal From OASIS-E
    CMS plans to remove two OASIS items, the M0110--Episode Timing and 
M2220--Therapy Needs effective January 1, 2025. These items are no 
longer used in the calculation of quality measures already adopted in 
the HH QRP, nor are they being used currently for previously 
established purposes unrelated to the HH QRP, including payment, 
survey, the HH VBP Model or care planning.
    CMS proposes the removal of items from OASIS-E from the specific 
time points during a home health episode as outlined in Table C3.

[[Page 43735]]

[GRAPHIC] [TIFF OMITTED] TP10JY23.064

    For a discussion in the reduction in burden associated with the 
removal of these items, see section IX of this proposed rule.
    We invite public comment on our proposal to remove the M0110--
Episode Timing and M2220--Therapy Needs items from OASIS-E, effective 
January 1, 2025.

F. Policies Regarding Public Display of Measure Data for the HH QRP

1. Background
    Section 1899B(g)(1) of the Act requires, in part, that the 
Secretary provide for public reporting of PAC provider performance, 
including HHAs, on quality measures under section 1899B(c)(1) of the 
Act, including by establishing procedures for making available to the 
public information regarding the performance of individual PAC 
providers with respect to such measures. Section 1899B(g)(2) requires, 
in part, that CMS give HHAs opportunity to review and submit 
corrections to the data and information to be made public under section 
1899B(g)(1) prior to such data being made public. Section 1899B(g)(3) 
of the Act requires that such procedures provide that the data and 
information with respect to a measure and PAC provider is made publicly 
available beginning not later than 2 years after the applicable 
specified application date applicable to such measure and provider. 
Measure data are currently publicly displayed on the Care Compare 
website, an interactive web tool that assists individuals by providing 
information on quality of care. For more information on Care Compare, 
we refer readers to our website at: https://www.medicare.gov/care-compare/.
2. Public Reporting of the Cross-Setting Functional Discharge Measure 
Beginning With the CY 2025 HH QRP
    We are proposing to begin publicly displaying data for the DC 
Function measure beginning with the January 2025 refresh of Care 
Compare, or as soon as technically feasible, using data collected from 
April 1, 2023 through March 31, 2024 (Quarter 2 2023 through Quarter 1 
2024). If finalized as proposed, an HHAs DC Function score would be 
displayed based on four quarters of data. Provider preview reports 
would be distributed in October 2024, or as soon as technically 
feasible. Thereafter, an HHA's DC Function score would be publicly 
displayed based on four quarters of data and updated quarterly. To 
ensure the statistical reliability of the data, we are proposing that 
we would not publicly report an HHAs performance on the measure if the 
HHA had fewer than 20 eligible cases in any quarter. HHAs that have 
fewer than 20 eligible cases would be distinguished with a footnote 
that notes that the number of cases/patient stays is too small to 
report.
    We invite public comment on the proposal for the public display of 
the Discharge Function Score measure beginning with the January 2025 
refresh of Care Compare, or as soon as technically feasible.
3. Public Reporting of the Transfer of Health Information to the 
Patient Post-Acute Care and Transfer of Health Information to the 
Provider Post-Acute Care Measures Beginning With the CY 2025 HH QRP
    We are proposing to begin publicly displaying data for the 
measures: (1) Transfer of Health (TOH) Information to the Provider--
Post-Acute Care (PAC) Measure (TOH-Provider); and (2) Transfer of 
Health (TOH) Information to the Patient--Post-Acute Care (PAC) Measure 
(TOH-Patient). We would begin displaying data with the January 2025 
Care Compare refresh or as soon as technically feasible. We adopted 
these measures in the fiscal year (FY) 2020 IPPS)/LTCH Prospective 
Payment System (PPS) final rule (84 FR 42525 through 42535). In 
response to the COVID-19 public health emergency (PHE), we released an 
interim final rule (85 FR 27595 through 27597) which delayed the 
compliance date for the collection and reporting of the TOH-Provider 
and TOH-Patient measures. The compliance date for the collection and 
reporting of the TOH-Provider and TOH-Patient measures was revised to 
October 1, 2022 in the calendar year (CY) 2022 Home Health PPS Rate 
Update final rule (86 FR 62386 through 62390). Data collection for 
these two assessment-based measures began with patients admitted and 
discharged on or after October 1, 2022.
    We are proposing to publicly display data for these two assessment-
based measures based on four rolling quarters, initially using 
discharges from April 1, 2023 through March 31, 2024 (Quarter 2 2023 
through Quarter 1 2024), and to begin publicly reporting these measures 
with the January 2025 refresh of Care Compare, or as soon as 
technically feasible. To ensure the statistical reliability of the 
data, we are proposing that we would not publicly report an HHAs 
performance on the measure if the HHA had fewer than 20 eligible cases 
in any quarter. HHAs that have fewer than 20 eligible cases would be 
distinguished with a footnote that notes that the number of cases/
patient stays is too small to report.
    We invite public comment on our proposal for the public display of 
the (1) Transfer of Health (TOH) Information to the Provider--Post-
Acute Care (PAC) Measure (TOH-Provider) and (2) Transfer of Health 
(TOH) Information to the Patient--Post-Acute Care (PAC)

[[Page 43736]]

Measure (TOH-Patient) assessment-based measures.
4. Public Reporting of the COVID-19 Vaccine: Percent of Patients/
Residents Who Are Up to Date Beginning With the CY 2026 HH QRP
    We are proposing to begin publicly displaying data for the COVID-19 
Vaccine: Percent of Patients/Residents Who Are Up to Date measure 
beginning with the January 2026 refresh of Care Compare or as soon as 
technically feasible using data collected for Q2 2024 (April 1, 2024 
through June 30, 2024). If finalized as proposed, an HHA's Patient/
Resident level COVID-19 Vaccine percent of patients who are up to date 
would be displayed based on one quarter of data. Provider preview 
reports would be distributed in October 2025, or as soon as technically 
feasible. Thereafter, the percent of HHA patients who are up to date 
with their COVID-19 vaccinations would be publicly displayed based on 
one quarter of data and updated quarterly. To ensure the statistical 
reliability of the data, we are proposing that we would not publicly 
report an HHAs performance on the measure if the HHA had fewer than 20 
eligible cases in any quarter. HHAs that have fewer than 20 eligible 
cases would be distinguished with a footnote that notes that the number 
of cases/patient stays is too small to report.
    We invite public comment on the proposal for the public display of 
the COVID-19 Vaccine: Percent of Patients/Residents Who Are Up to Date 
measure beginning with the January 2026 refresh of Care Compare, or as 
soon as technically feasible.

G. Health Equity Update

1. Background
    In the CY 2023 Home Health Payment Rate Update proposed rule (87 FR 
66866), we included a Request for Information (RFI) on several 
questions related to a proposed health equity measure concept. CMS 
defines health equity as ``the attainment of the highest level of 
health for all people, where everyone has a fair and just opportunity 
to attain their optimal health regardless of race, ethnicity, 
disability, sexual orientation, gender identity, socioeconomic status, 
geography, preferred language, or other factors that affect access to 
care and health outcomes.'' \102\ CMS is working to advance health 
equity by designing, implementing, and operationalizing policies and 
programs that support health for all the people served by our programs 
and models, eliminating avoidable differences in health outcomes 
experienced by people who are disadvantaged or underserved, and 
providing the care and support that our beneficiaries need to thrive. 
CMS's goals outlined in the CMS Framework for Health Equity 2022-2023 
\103\ are in line with Executive Order 13985, on Advancing Racial 
Equity and Support for Underserved Communities Through the Federal 
Government (January 25, 2021).\104\ The goals included in the CMS 
Framework for Health Equity include: strengthening CMS's infrastructure 
for assessment, creating synergies across the health care system to 
drive structural change, and identifying and working to eliminate 
barriers to CMS-supported benefits, services, and coverage.
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    \102\ Centers for Medicare and Medicaid Services. Available at 
https://www.cms.gov/pillar/health-equity. Accessed February 1, 2023.
    \103\ https://www.cms.gov/files/document/cms-framework-health-equity-2022.pdf.
    \104\ Executive Order 13985, on ``Advancing Racial Equity and 
Support for Underserved Communities Through the Federal 
Government,'' can be found at: https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/20/executive-order-advancing-racial-equity-and-support-for-underserved-communities-through-the-federal-government/.
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    In addition to the CMS Framework for Health Equity, CMS seeks to 
``advance health equity and whole-person care'' as one of eight goals 
comprising the CMS National Quality Strategy (NQS).\105\ The NQS 
identifies a wide range of potential quality levers that can support 
our advancement of equity, including: (1) establishing a standardized 
approach for resident-reported data and stratification; (2) employing 
quality and value-based programs to publicly report and incentivize 
closing equity gaps; and, (3) developing equity-focused performance 
metrics, regulations, oversight strategies, and quality improvement 
initiatives. The NQS also acknowledges the contribution of structural 
racism and other systemic injustices to the persistent disparities that 
underlie our healthcare system.
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    \105\ Centers for Medicare & Medicaid Services. What is the CMS 
Quality Strategy? Available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/CMS-Quality-Strategy.
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    Racial disparities in health, in particular, are estimated to cost 
the U.S. an estimated $93 billion in excess medical costs and $42 
billion in lost productivity per year, in addition to economic losses 
due to premature deaths.\106\ Racial and ethnic diversity has 
increased. An increase in the percentage of people who identify as two 
or more races accounts for most of the increase in diversity, rising 
from 2.9 percent to 10.2 percent between 2010 and 2020.\107\ Social 
determinants of health, including social, economic, environmental, and 
community conditions, may have a stronger influence on the population's 
health and well-being than services delivered by practitioners and 
healthcare delivery organizations.\108\
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    \106\ Ani Turner, The Business Case for Racial Equity, A 
Strategy for Growth, W.K. Kellogg Foundation and Altarum, April 
2018.
    \107\ 2022 National Healthcare Quality and Disparities Report, 
page 15. Content last reviewed November 2022. Agency for Healthcare 
Research and Quality, Rockville, MD. https://www.ahrq.gov/research/findings/nhqrdr/nhqdr22/index.html.
    \108\ 2022 National Healthcare Quality and Disparities Report. 
Content last reviewed November 2022, page 2. Agency for Healthcare 
Research and Quality, Rockville, MD. https://www.ahrq.gov/research/findings/nhqrdr/nhqdr22/index.html.
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    Measure stratification helps identify disparities by calculating 
quality measure outcomes separately for different beneficiary 
subpopulations. By looking at measure results for different populations 
separately, CMS and providers can see how care outcomes may differ 
between certain patient populations in a way that would not be apparent 
from an overall score (that is, a score averaged over all 
beneficiaries). This helps CMS to better fulfill their health equity 
goals. For example, certain quality measures related to oral healthcare 
outcomes for children, when stratified by race, ethnicity, and income, 
show how important health disparities have been narrowed, because 
outcomes for children in the lowest income households and for Black and 
Hispanic children improved faster than outcomes for children in the 
highest income households or for White children.\109\ These differences 
in outcomes would not be apparent without stratification.
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    \109\ 2022 National Healthcare Quality and Disparities Report, 
page 6. Content last reviewed November 2022. Agency for Healthcare 
Research and Quality, Rockville, MD. https://www.ahrq.gov/research/findings/nhqrdr/nhqdr22/index.html.
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    Additionally, the RFI solicited public comments on a potential 
health equity structural composite measure. We refer readers to the CY 
2023 Home Health Payment Rate Update final rule (87 FR 66866) for a 
summary of the public comments and suggestions received in response to 
the health equity RFI.
    We took these comments into account, and we continue to work to 
develop policies, quality measures, and measurement strategies on this 
important topic. After considering public comments, CMS decided to 
convene a health equity technical expert panel to provide additional 
input to inform the development of health equity quality measures. The 
work of this technical expert panel is described in detail in the 
following section.

[[Page 43737]]

2. Home Health and Hospice Health Equity Technical Expert Panel
    To support new health equity measure development, the Home Health 
and Hospice Health Equity Technical Expert Panel (Home Health & Hospice 
HE TEP) was convened by a CMS contractor in Fall 2022. The Home Health 
& Hospice HE TEP comprised health equity experts from hospice and home 
health settings, specializing in quality assurance, patient advocacy, 
clinical work, and measure development. The TEP was charged with 
providing input on a potential cross-setting health equity structural 
composite measure concept as set forth in the CY 2023 Home Health 
Payment Rate Update proposed rule (87 FR 66866) as part of an RFI 
related to the HH QRP Health Equity Initiative. In specific, the TEP 
assessed the face validity and feasibility of the potential structural 
measure. The TEP also provided input on possible confidential feedback 
report options to be used for monitoring health equity. TEP members 
also had the opportunity to provide ideas for additional health equity 
measure concepts or approaches to addressing health equity in hospice 
and home health settings. A summary of the Home Health and Hospice HE 
TEP meetings and final TEP recommendations are available at https://mmshub.cms.gov/sites/default/files/HomeHealth-Hospice-Health-Equity-TEP-Report-508c.pdf.
3. Anticipated Future Health Equity Activities
    CMS is committed to developing approaches to meaningfully 
incorporate the advancement of health equity into the HH QRP. We are 
considering health equity measures used in other settings like those in 
acute care that further health equity in post-acute care. We realize 
that the social determinants of health data items in post-acute care 
under the IMPACT Act of 2014 differ from the SDOH data items in the 
acute care health equity quality measures. We could consider a future 
health equity measure like screening for social needs and intervention. 
With 30 to 55 percent of health outcomes attributed to SDOH,\110\ a 
measure capturing and addressing SDOH could encourage providers to 
identify specific needs and connect residents with the community 
resources necessary to overcome social barriers to their wellness. We 
could specify it using the SDOH data items that we currently collect as 
SPADEs on the OASIS. These SDOH data items assess health literacy, 
social isolation, transportation problems, preferred language 
(including need or want of an interpreter), race, and ethnicity. These 
SDOH data items differ from data elements considered as screening items 
in the acute care settings, which are housing instability, food 
instability, transportation needs, utility difficulties, and 
interpersonal safety. This means that we might consider in the future 
adding the SDOH data items used by acute care providers into the HH QRP 
as we develop future health equity quality measures under our HH QRP 
statutory authority. This supports our desire to align quality measures 
across CMS consistent with the CMS path forward for advancing health 
equity solutions.\111\ Consistent with ``The Path Forward: Improving 
Data to Advance Health Equity Solutions'' (CMS OMH, November 2022) we 
also see value in aligning SDOH data items across all care settings and 
to the United States Core Data for Interoperability (USCDI) where 
applicable and appropriate. The USCDI is a standardized set of health 
data classes and constituent data elements for nationwide, 
interoperable health information exchange, including data elements and 
associated vocabulary standards to support computerized, interoperable 
use of SDOH data.\112\
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    \110\ World Health Organization (WHO). (n.d.). Social 
Determinants of Health. https://www.who.int/health-topics/social-determinants-of-health#tab=tab_1, accessed February 1, 2023.
    \111\ https://www.nejm.org/doi/full/10.1056/NEJMp2215539, 
February 1, 2023.
    \112\ https://www.healthit.gov/isa/united-states-core-data-interoperability-uscdi.
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    As we move this important work forward, we will continue to take 
input from interested parties. As of this publication, the Initial 
Proposals for Updating OMB's Race and Ethnicity Statistical Standards, 
(88 FR 5375), has collected public comment. Additionally, the Office of 
the National Coordinator for Health IT (ONC) welcomes submissions 
proposing additional data classes and data elements via the USCDI ONC 
New Data Element and Class (ONDEC) submission system for future 
versions of the USCDI.\113\ In addition, while some of the anticipated 
health equity efforts will proceed through the rulemaking process, 
other activities may be pursued through subregulatory channels, such as 
Open-Door Forums (ODF), Medicare Learning Network (MLN), and public 
summary reports such as TEP reports or information gathering reports 
(IGR).
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    \113\ https://www.healthit.gov/isa/ONDEC.
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H. Proposal To Codify HH QRP Data Completion Thresholds

1. Compliance
    Section 1895(b)(3)(B)(v)(I) of the Act requires that, for the CY 
2007 payment determination and subsequent years, each HHA submit to the 
Secretary quality data specified by the Secretary in a form and manner, 
and at a time, specified by the Secretary. As required in accordance 
with subclause (II) for such a year, for any HHA that does not submit 
data in accordance with section 1895(b)(3)(B)(v)(I) of the Act with 
respect to a given calendar year will result in the reduction of the 
annual home health market basket percentage increase otherwise 
applicable to an HHA for that calendar year by 2 percentage points. In 
the CY 2016 HH PPS final rule (80 FR 68703 through 68705), we finalized 
a proposal to define the quantity of OASIS assessments each HHA must 
submit to meet the pay-for reporting requirement. We finalized a 
proposal that would increase the reporting threshold for HHAs over 
three years, starting with the CY 2017 reporting period. HHAs were 
required to score at least 70 percent on the Quality Assessment Only 
(QAO) metric of pay-for-reporting performance requirement for CY 2017 
(reporting period July 1, 2015 to June 30, 2016), 80 percent for CY 
2018 (reporting period July 1, 2016 to June 30, 2017) and 90 percent 
for CY 2019 (reporting period July 1, 2017 to June 30, 2018) or be 
subject to a 2 percentage point reduction to their market basket update 
for that reporting period. In the 2018 HH PPS final rule (82 FR 51737 
through 51738), we proposed to apply the 90 percent threshold 
requirements established in the CY 2016 HH PPS rule to the submission 
of standardized patient assessment data beginning with the CY 2019 HH 
QRP.
2. Proposal To Codify HH QRP Data Completion Thresholds
    We propose to codify these data completeness thresholds at Sec.  
484.245(b)(2)(ii)(A) for measures data collected using the OASIS. Under 
this section, we propose to codify our requirement that HHAs must meet 
or exceed a data submission threshold set at 90 percent of all required 
OASIS and submit the data through the CMS designated data submission 
systems. This threshold would apply to required quality measures data 
and standardized patient assessment data collected adopted into the HH 
QRP. We also propose to codify our policy at Sec.  484.245(b)(2)(ii)(B) 
that a HHA must meet or exceed this threshold to avoid

[[Page 43738]]

receiving a 2-percentage point reduction to its annual payment update 
for a given CY as codified at Sec.  484.225(b).
    We invite public comment on our proposal to codify in regulations 
text the HH QRP data completion thresholds at Sec.  
484.245(b)(2)(ii)(A) for measures and standardized patient assessment 
elements collected using the OASIS and compliance threshold to avoid 
receiving 2 percentage point reduction as described under Sec.  
484.245(b)(2)(ii)(B).

I. Principles for Selecting and Prioritizing HH QRP Quality Measures 
and Concepts Under Consideration for Future Years: Request for 
Information (RFI)

1. Background
    CMS has established a National Quality Strategy \114\ for its 
quality programs which support a resilient, high-value health care 
system promoting quality outcomes, safety, equity and accessibility for 
all individuals. The CMS National Quality Strategy is foundational for 
contributing to improvements in health care, enhancing patient 
outcomes, and informing consumer choice. To advance these goals, CMS 
leaders from across the Agency have come together to move towards a 
building-block approach to streamline quality measures across CMS 
quality programs for the adult and pediatric populations. This 
``Universal Foundation'' \115\ of quality measures will focus provider 
attention, reduce burden, identify disparities in care, prioritize 
development of interoperable, digital quality measures, allow for 
cross-comparisons across programs, and help identify measurement gaps. 
The development and implementation of the Preliminary Adult and 
Pediatric Universal Foundation Measures will promote the best, safest, 
and most equitable care for individuals as we all come together on 
these critical quality areas.
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    \114\ Schreiber M, Richards A, Moody-Williams J, Fleisher L. The 
CMS National Quality Strategy: a person-centered approach to 
improving quality. Centers for Medicare and Medicaid Services. June 
6, 2022. Available at: https://www.cms.gov/blog/cms-national-quality-strategy-person-centered-approach-improving-quality. opens 
in new tab.
    \115\ Jacobs D, Schreiber M, Seshamani M, Tsai D, Fowler E, 
Fleisher L. Aligning Quality Measures across CMS--The Universal 
Foundation. N Engl J Med 2023; 338:776-779. DOI: 10.1056/
NEJMp2215539.
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    In alignment with the CMS National Quality Strategy, the HH QRP 
endeavors to move towards a more parsimonious set of measures while 
continually improving the quality of health care for beneficiaries. The 
purpose of this RFI is to gather input on existing gaps in HH QRP 
measures and to solicit public comment on either fully developed HH 
measures, fully developed measures in other programs that may be 
appropriate for the HH QRP, and measurement concepts that could be 
developed into HH QRP measures, to fill these measurement gaps. While 
we will not be responding to specific comments submitted in response to 
this RFI in the CY2024 HH PPS final rule, we intend to use this input 
to inform future policies.
    This RFI consists of four sections. The first section is the 
background. The second section discusses a general framework or set of 
principles that CMS utilizes to identify future HH QRP measures. The 
third section draws from an environmental scan conducted to identify HH 
QRP measurement gaps, and measures or measure concepts that could be 
used to fill these gaps. The final section solicits public comment on 
(a) the set of principles for selecting measures for the HH QRP, (b) 
identified measurement gaps, and (c) measures that are available for 
immediate use, or that may be adapted or developed for use in the HH 
QRP.
2. Guiding Principles for Selecting and Prioritizing Measures
    CMS has identified a set of principles to guide future HH QRP 
measure set development and maintenance. These principles are intended 
to ensure that measures resonate with beneficiaries and caregivers, do 
not impose undue burden on providers, align with CMS' post-acute care 
(PAC) program goals, and can be readily operationalized. Specifically, 
measures incorporated into the HH QRP should meet the following four 
objectives:
     Actionability--Optimally, HH QRP measures should 
focus on structural elements, healthcare processes, and outcomes of 
care that have been demonstrated, such as through clinical evidence or 
best practices, to be amenable to improvement. In other words, 
activities or approaches that contribute to improvement on a measure 
have been established and are feasible for providers to implement.
     Comprehensiveness and Conciseness--QRP measures 
should assess performance of all HH core services using the smallest 
number of measures that comprehensively assess the value of care 
provided in HH settings. Parsimony in the QRP measure set minimizes 
provider burden resulting from data collection and submission.
     Focus on Provider Responses to Payment--The HH 
PPS shapes incentives for care delivery. HH performance measures should 
neither exacerbate nor induce unwanted responses to the payment 
systems. As feasible, measures should identify and mitigate adverse 
incentives of the payment system.
     Alignment with CMS Statutory Requirements and 
Key Program Goals--Measures must align with CMS statutory requirements, 
such as the IMPACT Act of 2014 and the Meaningful Measures Framework as 
well as align across PAC programs where possible.
3. Gaps in HH QRP Measure Set Identified by Environmental Scan and 
Potential New Measures
    CMS conducted an environmental scan that utilized the previous-
listed principles to guide the identification of gaps in the HH QRP. 
Measurement gaps were identified in the domains of cognitive function, 
behavioral and mental health, and chronic conditions and pain 
management. We discuss each of these in more detail in the next 
section.
a. Cognitive Function
    Conditions associated with limitations in cognitive function, which 
may include stroke, traumatic brain injuries, dementia, and Alzheimer's 
disease, as well as intellectual and developmental disabilities (I/DD) 
affect an individual's ability to think, reason, remember, problem-
solve, and make decisions. The IMPACT Act identifies cognitive function 
as a key quality measure domain, and an area for inclusion as a 
standardized assessment data element.
    Two sources of information on cognitive function currently 
collected in HHAs are the Brief Interview for Mental Status (BIMS) and 
Confusion Assessment Method (CAM(copyright)).\116\ Both the BIMS and 
CAM have been incorporated into the OASIS. Scored by providers via 
direct observation, the BIMS is used to determine orientation and the 
ability to register and recall new information. The CAM assesses the 
presence of inattention, disorganized thinking, and level of 
consciousness.
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    \116\ Centers for Medicare & Medicaid Services. Outcome and 
Assessment Information Set (OASIS-E) Data Set. Effective January 1, 
2023. https://www.cms.gov/medicare/quality-initiatives-patient-assessment-instruments/homehealthqualityinits/oasis-data-sets.
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    The BIMS and CAM include items representing different aspects of 
cognitive function, from which quality measures may be constructed. 
Although these instruments have been subjected to feasibility, 
reliability, and validity testing, additional development and testing 
would be required prior to transforming the concepts reflected in the 
BIMS and CAM (for example,

[[Page 43739]]

temporal orientation, recall) into fully specified measures for 
implementation in the HH QRP.
    This RFI is requesting comment on cognitive functioning measures 
that may be available for immediate use, or that may be adapted or 
developed for use in the HH QRP, using the BIMS or the CAM. In addition 
to comment on specific measures and instruments, CMS seeks input on the 
feasibility of measuring improvement in cognitive functioning during a 
HH stay, which typically averages 56 days; \117\ the cognitive skills 
(for example, executive functions) that are more likely to improve 
during an HHA stay; conditions for which measures of maintenance--
rather than improvement in cognitive functioning--are more practical; 
and the types of intervention that have been demonstrated to assist in 
improving or maintaining cognitive functioning.
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    \117\ Based on home health episodes ending in CY2021 (the most 
recent year for which complete data are available).
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b. Behavioral and Mental Health
    Estimates suggest that one in five Medicare beneficiaries have a 
``common mental health disorder'' and nearly 8% have a serious mental 
illness.\118\ Behavioral and mental health includes substance use 
disorders (SUD), which are understudied in PAC.\119\ Research using 
National Survey on Drug Use and Health 2015-2019 data estimated that 
1.7 million Medicare beneficiaries, or 8 percent of those aged less 
than 65 years and 2 percent of those aged 65 years and older, had a 
past-year substance use disorder, 77 percent attributed to alcohol and 
16 percent attributed to prescription drugs.\120\ In some instances, 
such as following an ischemic stroke or a new diagnosis of a chronic 
condition such as diabetes, patients may develop depression, anxiety, 
or SUD. In other instances, patients may have been dealing with mental 
or behavioral health issues long before their post-acute admission. 
Left unmanaged, however, these conditions make it difficult for 
affected patients to actively participate in their rehabilitation and 
treatment regimen, thereby contributing to poor health outcomes.
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    \118\ Figueroa J, Phelan J, Orav E, Patel V, Jha A. Association 
of mental health disorders with health care spending in the Medicare 
population. JAMA Network Open 2020;3(3):e201210.
    \119\ Desai A, Grossberg G. Substance Use Disorders in Postacute 
and Long-Term Care Settings. Psychiatr Clin North Am. 2022 
Sep;45(3):467-482.
    \120\ Parish W, Mark T, Weber E, Steinberg D. Substance Use 
Disorders Among Medicare Beneficiaries: Prevalence, Mental and 
Physical Comorbidities, and Treatment Barriers. Am J Prev Med 2022 
Aug;63(2):225-232. Doi: 10.1016/j.amepre.2022.01.021.
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    Information on the availability and appropriateness of behavioral 
and mental health measures in PAC is limited, and the 2021 National 
Impact Assessment of the CMS Quality Measures Report \121\ identified 
PAC program measurement gaps in the areas of behavioral and mental 
health. Among the mental health quality measures in current use, the HH 
QRP uses a quality measure, ``Depression Assessment Conducted'' which 
is described as ``How often the home health team check patients for 
depression'' (CMS ID 0198-10). The measure was removed from Care 
Compare--Home Health in July 2021. Although it may be possible to adapt 
this measure for use in other PAC settings, this process measure does 
not directly assess performance in the management of depression and 
related mental health concerns.
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    \121\ Centers for Medicare & Medicaid Services. 2021 National 
Impact Assessment of the Centers for Medicare & Medicaid Services 
(CMS) Quality Measures Report. June 2021. https://www.cms.gov/files/document/2021-national-impact-assessment-report.pdf.
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    Information on behavioral and mental health currently collected in 
HHAs is the Patient Mood Interview (PHQ-2 to 9), a validated interview 
that screens for symptoms of depression, and provides a standardized 
severity score and a rating for evidence of a depressive disorder. The 
PHQ-2 to 9 identifies signs and symptoms of mood distress, a serious 
condition that is underdiagnosed and undertreated in home health and is 
associated with significant morbidity. There is currently no 
information on substance use disorder collected in HHAs.
    The PHQ-2 to 9 represents one mental health condition, from which 
quality measures may be constructed. Although this instrument has been 
subjected to feasibility, reliability, and validity testing, additional 
development and testing would be required prior to transforming the 
concepts reflected in the PHQ-2 to 9 into fully specified measures for 
implementation in the HH QRP.
    This RFI is requesting comment on behavioral and mental health 
measures that may be available for immediate use, or that may be 
adapted or developed for use in the HH QRP, using the PHQ-2 to 9. In 
addition to comment on specific measures and instruments, CMS seeks 
input on the feasibility of measuring improvement in depressive 
symptoms during a HH stay, which typically averages 56 days; \122\ the 
symptoms that are more likely to improve during an HHA stay; and the 
types of intervention that have been demonstrated to assist in 
improving depressive symptoms.
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    \122\ Based on home health episodes ending in CY2021 (the most 
recent year for which complete data are available).
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    CMS seeks feedback on behavioral and mental health, including 
substance use disorder, measures or instruments that may be directly 
applied, adapted, or developed for use in the HH QRP. Further, CMS 
seeks comment on the degree to which measures have been or will require 
validation and testing prior to application in the HH QRP. Input on the 
availability of data, the manner in which data could be collected and 
reported to CMS, and the burden imposed on providers is also sought.
c. Chronic Conditions and Pain Management
    Despite the availability of measures focused on core HHA clinical 
care services and, specifically, Improvement in Management of Oral 
Medications CBE #0176 (CMS ID 0189-11) and Improvement on Dyspnea CBE 
#0179 (CMS ID 0187-11). HH QRP measures do not directly address aspects 
of care rendered to populations with chronic conditions, such as 
chronic kidney disease or cardiovascular disease. Another example of a 
service area for which existing measures could more adequately capture 
HHA actions concisely is pain management. Even though pain has been 
demonstrated to contribute to falls with major injury and restrictions 
in mobility and daily activity, a host of other factors also contribute 
to these measure domains, making it difficult to directly link provider 
actions to performance. Instead, a measure of provider actions in 
reducing pain interference in daily activities, including the ability 
to sleep, would be a more concise measure of pain management. Beginning 
January 1, 2023, HHAs began collecting new standardized patient 
assessment data elements, including items that assess pain interference 
with (1) daily activities, (2) sleep, and (3) participation in therapy, 
providing an opportunity to develop more concise measures of provider 
performance.
    Through this RFI CMS is seeking input on measures of chronic 
condition and pain management that may be used to assess HHA 
performance. Additionally, CMS seeks general comment on the feasibility 
and challenges of measuring and reporting HHA performance on existing 
QRP measures, such as Discharge to the

[[Page 43740]]

Community (CBE #3479) and Potentially Preventable 30-day post-discharge 
readmissions, for subgroups of patients defined by type of chronic 
condition. For example, measures could assess rates of discharge to 
community or 30-day post-discharge readmissions among patients admitted 
to an HHA with chronic obstructive pulmonary disease (COPD) or chronic 
renal failure.
e. Solicitation of Public Comment
    We invite general comment on the principles for identifying HH QRP 
measures, as well as additional beliefs about measurement gaps, and 
suitable measures for filling these gaps. Specifically, we solicit 
comment on the following questions:
     Principles for Selecting and Prioritizing HH QRP Measures
    ++ To what extent do you agree with the principles for selecting 
and prioritizing measures?
    ++ Are there principles that you believe CMS should eliminate from 
the measure selection criteria?
    ++ Are there principles that you believe CMS should add to the 
measure selection criteria?
    ++ How can CMS best consider equity in measures?
     HH QRP Measurement Gaps
    ++ CMS requests input on the identified measurement gaps, including 
in the areas of cognitive function, behavioral and mental health, and 
chronic conditions and pain management.
    ++ Are there gaps in the HH QRP measures that have not been 
identified in this RFI?
     Measures and Measure Concepts Recommended for Use in the 
HH QRP
    ++ Are there measures that you believe are either currently 
available for use, or that could be adapted or developed for use in the 
HH QRP program to assess performance in the areas of: (1) cognitive 
functioning; (2) behavioral and mental health; (3) chronic conditions; 
(4) pain management; or (5) other areas not mentioned in this RFI?
    CMS also seeks input on data available to develop measures, 
approaches for data collection, perceived challenges, or barriers, and 
approaches for addressing challenges.

IV. Proposed Changes to the Expanded Home Health Value-Based Purchasing 
(HHVBP) Model

A. Background

    As authorized by section 1115A of the Act and finalized in the CY 
2016 HH PPS final rule (80 FR 68624), the Center for Medicare and 
Medicaid Innovation (Innovation Center) implemented the Home Health 
Value-Based Purchasing (HHVBP) Model (``original Model'') in nine 
states on January 1, 2016. The design of the original HHVBP Model 
leveraged the successes and lessons learned from other CMS value-based 
purchasing programs and demonstrations to shift from volume-based 
payments to a model designed to promote the delivery of higher quality 
care to Medicare beneficiaries. The specific goals of the original 
HHVBP Model were to--
     Provide higher incentives for better quality care with 
greater efficiency;
     Study new potential quality and efficiency measures for 
appropriateness in the home health setting; and,
     Enhance the current public reporting process.
    The original HHVBP Model resulted in an average 4.6 percent 
improvement in HHAs' total performance scores (TPS) and an average 
annual savings of $141 million to Medicare without evidence of adverse 
risks.\123\ The evaluation of the original Model also found reductions 
in unplanned acute care hospitalizations and skilled nursing facility 
(SNF) stays, resulting in reductions in inpatient and SNF spending. The 
U.S. Secretary of Health and Human Services determined that expansion 
of the original HHVBP Model would further reduce Medicare spending and 
improve the quality of care. In October 2020, the CMS Chief Actuary 
certified that expansion of the HHVBP Model would produce Medicare 
savings if expanded to all states.\124\
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    \123\ https://innovation.cms.gov/data-and-reports/2020/hhvbp-thirdann-rpt.
    \124\ https://www.cms.gov/files/document/certificationhome-health-value-based-purchasing-hhvbpmodel.pdf.
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    On January 8, 2021, CMS announced the certification of the HHVBP 
Model for expansion nationwide, as well as the intent to expand the 
Model through notice and comment rulemaking.\125\
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    \125\ https://www.cms.gov/newsroom/press-releases/cms-takes-action-improve-home-health-care-seniors-announces-intent-expand-home-health-value-based.
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    In the CY 2022 HH PPS final rule (86 FR 62292 through 62336) and 
codified at 42 CFR part 484 subpart F, we finalized the decision to 
expand the HHVBP Model to all Medicare certified HHAs in the 50 States, 
territories, and District of Columbia beginning January 1, 2022. CY 
2022 was a pre-implementation year. During CY 2022, CMS provided HHAs 
with resources and training, to allow HHAs time to prepare and learn 
about the expectations and requirements of the expanded HHVBP Model 
without risk to payments. We finalized that the expanded Model will 
generally use benchmarks, achievement thresholds, and improvement 
thresholds based on CY 2019 data to assess achievement or improvement 
of HHA performance on applicable quality measures and that HHAs will 
compete nationally in their applicable size cohort, smaller-volume HHAs 
or larger-volume HHAs, as defined by the number of complete unique 
beneficiary episodes for each HHA in the year prior to the performance 
year. All HHAs certified to participate in the Medicare program prior 
to January 1, 2022, will be required to participate and will be 
eligible to receive an annual Total Performance Score based on their CY 
2023 performance.
    We finalized the quality measure set for the expanded Model, as 
well as policies related to the removal, modification, and suspension 
of applicable measures, and the addition of new measures and the form, 
manner and timing of the OASIS-based, Home Health Consumer Assessment 
of Healthcare Providers and Systems (HHCAHPS) survey-based, and claims-
based measures submission in the applicable measure set beginning in CY 
2022 and subsequent years. We also finalized an appeals process, an 
extraordinary circumstances exception policy, and public reporting of 
annual performance data under the expanded Model.
    Additionally, in the CY 2022 HH PPS final rule (86 FR 62312), we 
summarized and responded to comments received on the challenges unique 
to value-based purchasing frameworks in terms of health equity and ways 
in which we could incorporate health equity goals into the expanded 
HHVBP Model. Comments received were related to the use of stabilization 
measures to promote access to care for individuals with chronic illness 
or limited ability to improve; collection of patient level demographic 
information for existing measures; and stratification of outcome 
measures by various patient populations to determine how they are 
affected by social determinants of health (SDOH).
    In the CY 2023 HH PPS final rule (87 FR 66869 through 66876), we 
finalized our policy to replace the term baseline year with the terms 
HHA baseline year and Model baseline year, and to change the calendar 
years associated with each of those baseline years. Specifically, we 
changed the HHA baseline year for the CY 2023 performance year from 
2021 to 2022 for ``new'' HHAs with CMS certification numbers (CCNs) 
with effective dates prior 2022, and the Model baseline year from CY 
2019 to CY

[[Page 43741]]

2022 starting in CY 2023. Additionally, we summarized the comments 
received on future approaches to health equity (HE) in the expanded 
HHVBP Model. Comments received were related to the support of 
addressing health equity, potential unintended consequences, thorough 
consideration and testing of potential HE measures, data collection 
and, applying HE data to the expanded Model's cohorts and risk 
adjustment models.

B. Proposed Changes to the Applicable Measure Set

    We are proposing to make changes to the applicable measure set. 
First, we are proposing to codify the HHVBP measure removal factors 
effective in CY 2024. Second, we are proposing to remove five measures 
from the current applicable measure set and add three measures starting 
in CY 2025. Third, due to the net change in the number of measures 
proposed, we are proposing to adjust the weights for the measures in 
the OASIS-based and claims-based measure categories starting in CY 
2025. Lastly, we are proposing to update the Model baseline year for 
all measures starting in CY 2025.
1. Codification of the HHVBP Measure Removal Factors
    In the CY 2022 HH PPS final rule (86 FR 62312), we stated that 
removal of an expanded HHVBP Model measure would take place through 
notice and comment rulemaking. In that same final rule (86 FR 62311 
through 62312), we adopted eight measure removal factors that we 
consider when determining whether to remove measures from the expanded 
HHVBP Model's applicable measure set:
     Factor 1. Measure performance among HHAs is so high and 
unvarying that meaningful distinctions in improvements in performance 
can no longer be made (that is, topped out).
     Factor 2. Performance or improvement on a measure does not 
result in better patient outcomes.
     Factor 3. A measure does not align with current clinical 
guidelines or practice.
     Factor 4. A more broadly applicable measure (across 
settings, populations, or conditions) for the particular topic is 
available.
     Factor 5. A measure that is more proximal in time to 
desired patient outcomes for the particular topic is available.
     Factor 6. A measure that is more strongly associated with 
desired patient outcomes for the particular topic is available.
     Factor 7. Collection or public reporting of a measure 
leads to negative unintended consequences other than patient harm.
     Factor 8. The costs associated with a measure outweigh the 
benefit of its continued use in the program.
    To be consistent with the HH QRP and other quality reporting 
programs (that is SNF QRP, IRF QRP, and LTCH QRP) we propose to codify 
the eight HHVBP measure removal factors for the expanded Model at Sec.  
484.380.
    We invite public comments on this proposal.
2. Changes to the Applicable Measure Set
a. Background
    In the CY 2022 HH PPS final rule (86 FR 66308 through 66310), we 
finalized the applicable measure set effective in the CY 2022 pre-
implementation year and subsequent years, which includes five OASIS-
based measures, two claims-based measures, and five HHCAHPS Survey-
based measures (see Table D1). Details of these measures were included 
in Tables 26 and 27 of the CY 2022 HH PPS proposed rule (86 FR 35923 
through 35926).
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    In that same final rule (86 FR 62310 through 62313), we finalized 
that, during the expanded Model, we would address any needed 
adjustments or modifications to the applicable measure set; this 
process involves notice and comment rulemaking for removing or adding 
measures and for adopting changes to measures that we consider to 
substantially change the nature of the measure. We also post the names 
of any measures added to the expanded Model finalized through the 
rulemaking process on the CMS website by the first December 1 upon 
publication of the applicable final rule. Examples of changes that we 
might consider to be substantive would be those in which the changes 
are so significant that the measure is no longer the same measure, or 
when a standard of performance assessed by a measure becomes more 
stringent, such as changes in acceptable timing of medication, 
procedure/process, test administration, or expansion of the measure to 
a new setting. If an update to a measure is necessary in a manner that 
we consider to not substantially change the nature of the measure, we 
will use a subregulatory process to incorporate those updates to the 
measure specifications that apply to the program. Specifically, we 
would revise the information that is posted on the CMS website so that 
it clearly identifies the updates and provides links to where 
additional information on where the updates can be found.
    We have determined that five of the measures finalized in the CY 
2022 HH PPS final rule require further

[[Page 43742]]

consideration. Specifically, we are proposing to remove the following 
measures from the applicable measure set: (1) OASIS-based Discharged to 
Community (DTC); (2) OASIS-based Total Normalized Composite Change in 
Self-Care (TNC Self-Care); (3) OASIS-based Total Normalized Composite 
Change in Mobility (TNC Mobility); (4) claims-based Acute Care 
Hospitalization During the First 60 Days of Home Health Use (ACH); and 
(5) claims-based Emergency Department Use without Hospitalization 
During the First 60 Days of Home Health (ED Use).
    We propose to replace these five measures with three measures (see 
Table D2). Specifically, we are proposing to add the following 
measures: (1) the claims-based Discharge to Community-Post Acute Care 
(DTC-PAC) Measure for Home Health Agencies; (2) the OASIS-based 
Discharge Function Score (DC Function) measure; and (3) the claims-
based Home Health Within-Stay Potentially Preventable Hospitalization 
(PPH) measure. The claims-based DTC-PAC measure would replace the 
OASIS-based DTC measure. The OASIS-based DC Function measure would 
replace the two OASIS-based TNC measures (Self-Care and Mobility). The 
claims-based PPH measure would replace the claims-based ACH and ED Use 
measures.
    We are proposing to make these changes to the applicable measure 
set beginning with the CY 2025 performance year and subsequent 
performance years. The proposed changes will align the measures used in 
the expanded HHVBP Model with the measures in the HH QRP and publicly 
reported on Home Health Care Compare. This alignment will support 
comparisons of provider quality and streamline home health providers' 
data capture and reporting processes. Table D2 summarizes the proposed 
applicable measure set that would be effective for the CY 2025 
performance year (CY 2027 payment year).
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b. Changes to the Applicable Measure Set
    We propose to make all changes to the applicable measure set 
discussed in this rule beginning with the CY 2025 performance year, 
thus all changes will affect the same payment year beginning with the 
CY 2027 payment year.
(1) Proposal To Replace the OASIS-Based DTC Measure With the Claims-
Based DTC-PAC Measure Beginning CY 2025
    We propose to replace the current OASIS-based DTC measure with the 
claims-based DTC-PAC measure. The claims-based DTC-PAC measure assesses 
successful discharge to the community from an HHA, with successful 
discharge to the community including no unplanned re-hospitalizations 
and no death in the 31 days following discharge. This measure was 
adopted as part of the Home Health Quality Reporting Program (HH QRP) 
in the CY 2017 HH PPS final rule (81 FR 76765 through 76770). Details 
about the measure can be found in the CY 2017 HH PPS final rule (81 FR 
76765 through 76770) and the CY 2018 HH PPS final rule (84 FR 60564 
through 60566). One difference between the current OASIS-based DTC 
measure and the proposed claims-based DTC-PAC measure is the time 
period of the measure. The proposed claims-based DTC-PAC measure uses 
two years of claims data, whereas the current OASIS-based DTC measure 
uses one year of OASIS data. Furthermore, the claims-based DTC-PAC 
measure is aligned across PAC settings in terms of risk-adjustment, 
exclusions, numerator, and measure intent, whereas the OASIS-based DTC 
measure is not aligned. Therefore, making the replacement is in 
accordance with Measure Removal Factor 4: A more broadly applicable 
measure (across settings, populations, or conditions) for the 
particular topic is available. Additionally, the replacement would 
further align the expanded HHVBP Model applicable measure set with the 
HH QRP measures. The HH QRP added the claims-based DTC measure in 2017 
and stopped publicly reporting the OASIS-based DTC measure in 2017. The 
proposed use of the claims-based DTC-PAC measure has additional 
benefits as compared to the current OASIS-based DTC measure in that it 
assesses broader outcomes by assessing post-discharge hospitalization 
and mortality. Specifically, it first examines whether a patient was 
discharged to the community from the PAC setting. For patients 
discharged to the community, this measure examines whether they 
remained alive in the community without an unplanned admission to an 
acute care hospital or LTCH in the 31-day post-discharge observation 
window following discharge to the community.
(2) Proposal to Jointly Replace the OASIS-Based TNC Self-Care and TNC 
Mobility Measures With the OASIS-Based Discharge Function Score Measure 
Beginning CY 2025
    We propose to jointly replace the TNC Self-Care and TNC Mobility 
measures with the DC Function measure. We adopted the TNC Self-Care and 
TNC Mobility measures in the CY 2019 HH PPS final rule (83 FR 56529 
through 56535) for use in the original Model beginning with performance 
year 4 (CY 2019). The TNC measures, which are composite measures, 
replaced three individual measures (Improvement in Bathing, Improvement 
in Bed Transferring, and Improvement in Ambulation-Locomotion). For 
these composite measures, HHA performance on the three mobility OASIS-
items are included in the TNC measures. The TNC measures also include 
six additional activities of daily living (ADL) measures to create a 
more comprehensive assessment of HHA performance across a broader range 
of patient ADL outcomes. The TNC measures report the magnitude of 
patient change (either improvement, no change, or decline) across six 
self-care and three mobility patient functional activities. This 
methodology accounts for changes to the scores on individual OASIS 
items while also considering that not all patients are able to improve 
on all aspects of each composite measure. The DC Function measure 
determines how successful each HHA is at achieving an expected level of 
functional ability for its patients at discharge. An expectation for 
discharge function score is built for each HHA episode by accounting 
for patient characteristics that impact their functional status. The 
final DC Function measure for a given HHA is the proportion of that 
HHA's episodes where a patient's observed discharge score meets or 
exceeds their expected discharge score. Functional status is measured 
through Section GG of OASIS assessments, which are cross-setting items. 
Section GG evaluates a patient's capacity to perform daily activities 
related to three self-care (GG0130) activities and eight mobility 
(GG0170) activities.
    The DC Function measure has been proposed for adoption in all PAC 
settings. We included the proposed DC Function measure on the 2022 
Measure Under Consideration (MUC) list for the Inpatient Rehabilitation 
Facility QRP, Home Health QRP, Long Term Care Hospital QRP, SNF QRP, 
and SNF VBP.\126\ It is proposed for the Skilled Nursing Facility (SNF) 
Value-Based Purchasing program in the FY 2024 SNF PPS proposed rule and 
in this CY 2024 HH PPS proposed rule for adoption in the HH QRP 
beginning CY 2025; details about the measure can be found in section 
III.D. of this proposed rule. We propose adopting the measure for the 
expanded HHVBP Model on the same timeline as the HH QRP (CY 2025) given 
that the GG items used in the measure have gone through extensive 
testing, and the measure has received conditional support for 
rulemaking as part of the most recent Measure Applications Partnership 
(MAP) process. While the DC Function measure is not yet implemented in 
the HH QRP or other PAC programs, the OASIS data elements used to 
calculate this measure have been collected since 2019. As such, we 
believe HHAs have had sufficient time to ensure successful reporting of 
the data elements needed for this measure.
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    \126\ See CMS, Measures Under Consideration List for 2022 (Dec. 
1, 2022), available at https://mmshub.cms.gov/sites/default/files/2022-MUC-List.xlsx.
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    Replacement of the TNC measures with the DC Function measure would 
further align the expanded HHVBP Model measure set with the HH QRP 
measures, as well as with other PAC settings. For these reasons, this 
replacement is in accordance with Measure Removal Factor 4. 
Additionally, the DC Function measure addresses self-care and mobility 
through a single measure rather than two measures, thereby streamlining 
the calculation and reporting of measure results.
(3) Proposal to Jointly Replace the Acute Care Hospitalization During 
the First 60 Days of Home Health Measure and Emergency Department Use 
Without Hospitalization During the First 60 Days of Home Health Measure 
With the Home Health Within Stay Potentially Preventable 
Hospitalization (PPH) Measure Beginning CY 2025
    We propose to jointly replace the Acute Care Hospitalization During 
the First 60 Days of Home Health Measure (``ACH'' measure) and 
Emergency Department Use Without Hospitalization During the First 60 
Days of Home Health Measure (``ED Use'' measure) with the Home Health 
Within Stay Potentially Preventable Hospitalization (PPH) Measure. The

[[Page 43745]]

current specifications for the PPH measure are available on the CMS 
website at https://www.cms.gov/files/document/hh-qrp-specificationspotentiallypreventablehospitalizations.pdf.
    The CY 2022 HH PPS final rule (86 FR 62340 through 62345) finalized 
the joint replacement of the ACH measure and ED Use measure with the 
PPH measure in the HH QRP beginning CY 2023. This replacement under the 
HH QRP was made under Measure Removal Factor 6: A measure that is more 
strongly associated with desired patient outcomes for the particular 
topic is available. Additional details of the reason for replacement 
are found in the CY 2022 HH PPS final rule (86 FR 62340 through 62345). 
Because these measures have been finalized to be jointly replaced with 
the PPH measure in the HH QRP beginning CY 2023, we are proposing to 
remove them from the expanded HHVBP Model.
    In the CY 2022 HH PPS proposed rule (86 FR 35929), we requested 
comments on whether we should align the expanded HHVBP Model with the 
proposed changes for the HH QRP by proposing to remove the same two 
measures (``ACH'' and ``ED Use'' measures) from the expanded Model in a 
future year. As summarized in the CY 2022 HH PPS final rule (86 FR 
62312), the feedback was generally supportive, recommending that the 
expanded HHVBP Model's applicable measure set align with the HH QRP 
measures. Replacing ACH and ED Use with PPH would further align the 
expanded Model's applicable measure set with the HH QRP measures.
    We propose no changes to the five HHCAHPS Survey-based measures 
used for the expanded HHVBP Model.
    We invite public comments on these proposals.
3. Measure Categories
    As shown in Table D3, the expanded Model utilizes established 
measure categories that represent the data sources including OASIS-
based, claims-based, and HHCAHPS Survey-based. Although measures in the 
original Model have been added, removed or substituted in the past, the 
measure category weights have remained constant, maintaining the 
weighting proportions of 35 percent, 35 percent and 30 percent for 
OASIS-based, claims-based and HHCAHPS Survey-based measures for the 
larger-volume cohort, respectively. For HHAs in the smaller-volume 
cohort, the weighting proportions of the OASIS-based and claims-based 
measures are 50 percent and 50 percent, respectively. Weights for 
individual measures within these categories have changed in the past 
due to changes to the applicable measure set (for example, replacing 
three individual OASIS-based measures with the two TNC measures) and to 
encourage improvement in the claims-based measures. With the proposed 
changes to the applicable measures in this proposed rule, the number of 
measures within the OASIS-based measure category would change. Table D3 
illustrates the change in the measure set including the removal of the 
OASIS-based DTC measure, the replacement of the two OASIS-based TNC 
change measures to the OASIS-based DC Function measure, and the 
replacement of the claims-based Acute Hospitalization Measure and 
claims-based ED Use Measure for the claims-based PPH measure. Despite 
the changes to the applicable measure set, we intend to maintain the 
existing measure categories and their relative weights. For example, 
for the larger-volume cohort, the claims-based measures would continue 
to have a total weight of 35 percent. The relatively higher weight 
given to the claims-based measures reflects our belief in the 
importance of those measures relative to OASIS-based measures, which 
use self-reported data and that the incentive to reduce hospital 
utilization is maintained. We continually monitor the effects of 
weighting and will propose changes if we determine there is a need 
through future rulemaking.
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4. Weighting and Redistribution of Weights Within the Measure 
Categories
a. Background
    As finalized in the CY 2022 HH PPS final rule (86 FR 62240), the 
expanded HHVBP Model uses the same policies regarding the weighting of 
measures and the redistribution of weights when measures or measure 
categories are missing as under the original Model (83 FR 56536).
    As previously discussed in section IV.B.2.b of this proposed rule, 
to align with quality measures used in the HH QRP, CMS proposes to 
replace the OASIS-based DTC measure with the claims-based DTC measure, 
jointly replace the claims-based ACH and ED Use measures with the 
claims-based PPH measure, and jointly replace the OASIS-based TNC 
Change in Mobility and TNC Change in Self-Care measures with the OASIS-
based DC Function measure in CY 2025 and subsequent performance years. 
Due to these changes to the applicable measure set and the data 
sources, CMS proposes changes in weights and redistribution of weights 
within the measure categories accordingly.
b. Quality Measure Weights Within Measure Categories
    Along with the proposed revisions to the current measure set, we 
propose to revise the weights of the individual measures within the 
OASIS-based measure category and within the claims-based measure 
category. Currently, the OASIS-based, claims-based, and HHCAHPS Survey-
based measures contribute 35 percent, 35 percent, and 30 percent, 
respectively, to the Total Performance Score (TPS) for HHAs in the 
larger-volume cohort. For HHAs in the smaller-volume cohort, the OASIS-
based and claims-based measures contribute 50 percent and 50 percent, 
respectively, to the TPS. The weights of the measure categories, when 
one category is missing, are based on the relative weight of each 
category when all measures are used. For example, if an HHA is missing 
the HHCAHPS Survey-based measure category, the remaining two measure 
categories (OASIS-based and claims-based) each represent 50 percent. 
Table 28 in the CY 2022 HH PPS final rule (86 FR 62323 through 62324) 
presents the current weights for measures and measure categories under 
various reporting scenarios.
    Table D4 shows the measure weights by quality measure in the 
expanded HHVBP Model currently in place and proposed for CY 2025 and 
subsequent performance years for HHAs in the larger-volume and smaller-
volume cohort, respectively.
    As discussed in section IV.B.3 of this proposed rule, for HHAs in 
the larger-volume cohort, we are keeping the measure category weights 
unchanged at 35 percent, 35 percent, and 30 percent for OASIS-based, 
claims-based, and HHCAHPS Survey-based measure categories, 
respectively. Similarly, for HHAs in the smaller-volume cohort, we are 
keeping the measure category weights unchanged at 50 percent and 50 
percent for OASIS-based and claims-based measure categories, 
respectively. By keeping these measure category weights unchanged, the 
number of individual measures in each measure category will affect the 
magnitude of the individual measure weights. As proposed, changes to 
the applicable measure set would decrease the OASIS-based measures from 
five measures to three, while the number of individual

[[Page 43747]]

measures for the claims-based measures and HHCAHPS Survey-based 
measures will remain unchanged. Given these proposals, the individual 
measure weights within the proposed OASIS-based measure category would 
be higher than those under the current applicable OASIS-based measure 
category. The subsequent sections discuss in more detail the proposed 
measure weight redistributions for each measure category.
(1) Proposal To Redistribute Weights Within the OASIS-Based Measure 
Category
    Because we propose to replace the two TNC measures jointly with the 
DC Function measure, we propose that the sum of the TNC measure weights 
be given to the DC Function measure. This will maintain the same 
relative weight for functional measures. Due to the proposed removal of 
the OASIS-based DTC measure, we also propose to distribute the weight 
for that measure across the remaining three OASIS-based measures. In 
addition, we propose to maintain a relatively small weight for 
Improvement in Dyspnea compared to the other measures in the applicable 
measure set. Under the current measure set, Improvement in Dyspnea is 
weighted at 5.833 for larger-volume HHAs and 8.333 for smaller-volume 
HHAs. Similarly, under the proposed applicable measure set, Improvement 
in Dyspnea would be weighted at 6.000 for the larger-volume cohort and 
8.571 for the smaller-volume cohort. This approach aims to encourage 
improvement in quality of care, while reducing its importance relative 
to other quality measures that encourage both improvement and 
maintenance of quality care for all home health patients. These 
proposed changes would be effective in CY 2025. Table D4 describes the 
proposed measure weight redistributions for all measure categories by 
larger-volume and smaller-volume cohort, respectively. In addition to 
increasing the individual measure weight for Improvement in Dyspnea to 
6.000, CMS proposes to increase the individual measure weight for 
Improvement in Management of Oral Medications to 9.000 and to assign 
the individual measure weight for DC Function to 20.000 for HHAs in the 
larger-volume cohort. These changes maintain the overall weight of the 
OASIS-based measures at 35 percent for the larger-volume cohort and 50 
percent for the smaller-volume cohort.
[GRAPHIC] [TIFF OMITTED] TP10JY23.069

(2) Proposal To Redistribute Weights Within the Claims-Based Measure 
Category
    Because we propose to remove the ACH and ED Use measures, we 
propose to allot an individual measure weight of 26.000 to the proposed 
PPH measure. The redistribution to the PPH measure is intended to give 
this measure approximately the same combined weight as the ACH and ED 
Use measures had previously. In addition, CMS proposes to allot an 
individual measure weight of 9.000 to the claims-based DTC-PAC measure 
for the larger-volume cohort. The slight increase in weight for the 
claims-based DTC-PAC measure maintains the same overall weight of 
35.000 for claims-based measures for the larger-volume cohort. Table D4 
lists the corresponding individual claims-based measure weight 
redistributions applicable to HHAs in the smaller-volume cohort.

[[Page 43748]]

(3) Weights Within the HHCAHPS-Based Measure Category
    Given there are no changes proposed to the measures within the 
HHCAHPS Survey-based measure category, we propose to keep the 
individual measure weights for measures in this measure category 
unchanged. Specifically, each HHCAHPS Survey-based measure will 
continue to have an individual measure weight of 6.000 for HHAs in the 
larger-volume cohort. Given that HHAs in the smaller-volume cohort are 
not assessed based on their HHCAHPS Survey-based measure performance, 
the individual measure weight is set to zero (0.000) for the smaller-
volume cohort (see Table D4).
    We invite public comments on these proposals.
(4) Alternatives Considered
    Several measure weighting alternatives were considered prior to 
choosing the previously discussed proposals. Tables D5 describes these 
alternative options for HHAs in the larger-volume cohort, including 
weights proportional to the weights for the initial measure set (Option 
1), maintaining measure category weights consistent with current 
measure set weights and equal within-category weights (Option 2), using 
equal measure category weights and maintaining within-category weight 
proportions (Option 3), using equal measure category weights and equal 
within-category weights (Option 4), and having equal weights for all 
measures (Option 5). We also considered these options for the smaller-
volume cohort and came to the same conclusions. Therefore, we only 
provide a table with measure weighting alternatives for the larger-
volume cohort.
[GRAPHIC] [TIFF OMITTED] TP10JY23.070

    Of these alternatives, Option 1 is most consistent with the 
proposed weights and most consistent with the weights used for the 
current measure set; however, it fails to apply the minimal weight 
possible for Improvement in Dyspnea. Similarly, Options 2-4 do not 
reduce the weight for Improvement in Dyspnea and deviate more 
substantially than Option 1 from the current weighting scheme. By 
attributing equal weight to all measures in the proposed measure set, 
Option 5 satisfies the minimal weight criterion for Improvement in 
Dyspnea; however, it does so at the expense of applying the same 
weight, which is inconsistent with previous decisions about apply 
differential weighting to measures to incentivize HHAs to act on 
improving measures with higher weights in the applicable measure set as 
outlined in the CY 2022 HH PPS final rule (86 FR 62322).
5. Updates to the Model Baseline Year
a. Background
    In the CY 2022 HH PPS final rule, we finalized that the first Model 
baseline year for the expanded HHVBP Model would be CY 2019 (January 1, 
2019 through December 31, 2019), the first performance year would be CY 
2023, and the first payment year would be CY 2025 (86 FR 62294 through 
62300). We decided on CY 2019 as the Model baseline year, as opposed to 
CY 2020 or CY 2021, due to the potentially de-stabilizing effects of 
the public health emergency (PHE) on the CY 2020 data and because it 
was the most recent full year of data available prior to CY 2020. The 
performance year and payment year were finalized after originally 
proposing CY 2022 to be the first performance year and CY 2024 to be 
the first payment year. We decided to delay implementation by 1 year to 
allow additional time for HHAs to prepare and learn about the expanded 
Model, thus CY 2022 was defined as the pre-

[[Page 43749]]

implementation year. In the CY 2023 HH PPS final rule, we changed the 
Model baseline year to CY 2022 (87 FR 66869 through 66874). We decided 
to use more recent data from the CY 2022 time period because it is more 
likely to be aligned with performance years' data under the expanded 
Model, and provide a more appropriate baseline for assessing HHA 
improvement for all measures under the Model as compared to both the 
pre-PHE CY 2019 data, as previously finalized for existing HHAs, and 
the CY 2021 data, as previously finalized for new HHAs certified 
between January 1, 2019 and December 31, 2020.
    Additionally, in the CY 2022 HH PPS final rule (86 FR 62308 through 
62309), we finalized the current measure set, as indicated in Table 25 
of that final rule. The removal and replacement of measures from the 
current measure set necessitates an updated implementation and data 
reporting timeline, which will be applied to all applicable measures so 
that the Model baseline year is consistent across measures.
b. Proposal To Update the Model Baseline Year
    Beginning with performance year CY 2025, we propose to update the 
Model baseline year to CY 2023 for all applicable measures in the 
proposed measure set, including those measures included in the current 
measure set. The one exception is the new claims-based DTC-PAC measure, 
which uses two years of data. As such, the Model baseline year for the 
claims-based DTC-PAC measure will be CY 2022 and CY 2023 for the 2-year 
performance year spanning CY 2024 and CY 2025. For performance years CY 
2023 and CY 2024, the Model baseline year will continue to be CY 2022. 
Table D6 lists the data periods for each measure and respective Model 
baseline, performance year, and payment years.
[GRAPHIC] [TIFF OMITTED] TP10JY23.071

    If we finalize our proposal to use CY 2023 for the Model baseline 
year, we would provide HHAs with the final achievement thresholds and 
benchmarks in the July 2024 Interim Performance Report (IPR). For all 
measures but the claims-based DTC-PAC measure, this timeline allows for 
one year of performance between the first performance year and the 
proposed updated Model baseline year. Because the claims-based DTC-PAC 
measure is a two-year measure, there will be no gap between the 
proposed updated Model baseline year and the first performance year, 
which would be consistent with the rollout of the original HHVBP Model, 
in which benchmarks and achievement thresholds using CY 2015 data were 
made available to HHAs during the summer of the first performance year 
(CY 2016).
    Furthermore, because the claims-based DTC-PAC measure is a 2-year 
measure, there will be an overlap in how discharge to community is 
measured for the expanded Model. Specifically, CY 2024 performance will 
be based on the current measure set, which includes the OASIS-based DTC 
measure. For the OASIS-based DTC measure, CY 2024 performance will be 
compared to baseline year CY 2022. CY 2025 performance would be based 
on the proposed measure set, which includes the claims-based DTC-PAC 
measure and thus replaces the OASIS-based DTC measure. Because the DTC-
PAC measure is a two-year measure, CY 2025 performance for the claims-
based DTC-PAC measure will be calculated based on two years of 
performance data (CY 2024/2025) and compared to two years of baseline 
year data (CY 2022/2023). Thus, for both the OASIS-based DTC measure 
and the claims-based DTC-PAC measure, CY 2022 data will be used to 
calculate performance in a Model baseline year, and CY 2024 data will 
be used to calculate performance in a performance year. Beyond CY 2025, 
data for calculating DTC-PAC performance will continue to overlap. For 
example, CY 2026 DTC-PAC (claims-based) performance will be based on 
data from CY 2025/2026, which overlaps by one year with the CY 2025 
DTC-PAC (claims-based) performance year data. See Table D7. The DTC-PAC 
measure was designed as a 2-year measure to optimize reliability. In 
addition, each performance year will consist of 1 year of performance 
data that does not overlap with the prior performance year data, which 
provides sufficient opportunity to capture quality improvement over 
time. Finally, the DTC-PAC (claims-based) will provide a smoother 
performance trend over time compared to 1-year measures by reflecting 
performance across a longer reporting period.

[[Page 43750]]

[GRAPHIC] [TIFF OMITTED] TP10JY23.072

BILLING CODE 4120-01-C
c. Alternatives Considered
    We considered several alternative timelines for updating the Model 
baseline year. First, we considered leaving the baseline year at CY 
2022 for those measures on the previously finalized measure set. We 
opted against this alternative because it uses less recent data and 
makes it more difficult for HHAs to track which achievement thresholds 
and benchmarks are based on which years of baseline data.
    Second, because of the time between the Model baseline year and the 
performance year, we considered delaying the implementation of the 
claims-based DTC-PAC measure by one year. Under this scenario, the 
measure's baseline year would remain CY 2022/2023, but the measure's 
first performance year would be CY 2025/2026. The first payment year 
that uses the claims-based DTC-PAC measure would then be CY 2028. As 
such, CY 2025 would be a transition year in between the current 
applicable measure set and the proposed applicable measure set. During 
this transition year, the OASIS-based DTC measure could be retained 
through CY 2025 or removed. Retaining the OASIS-based DTC measure 
during the transition year would ensure that the concept of being 
discharged to the community will be reflected in all performance and 
payment years, while removing it before the transition year would 
better align with the removal of the other measures as proposed. 
Because we view the concept of being discharged to the community as an 
important aspect of home health quality, we favor retaining the OASIS-
based DTC measure during the transition year over removing it, assuming 
we delay implementation of the claims-based DTC measure. We rejected 
delayed implementation, however, because it temporarily increases the 
complexity of the expanded Model and requires that the Model uses the 
legacy OASIS-based DTC measure for another year, despite its removal 
from the HH QRP.
    Third, we considered delaying implementation of the OASIS-based DC 
Function measure, which is proposed for CY 2025 implementation in the 
HH QRP as indicated in section III. D.1. of this proposed rule. 
Although a delay would allow more time to evaluate the measure's 
performance prior to HHVBP implementation, data utilized in this 
measure have been a part of the HH QRP's OASIS assessment tool since CY 
2019. We prefer the proposed timeline for the OASIS-based DC Function 
measure because it expedites alignment with the HH QRP, SNF VBP, and 
the other PAC programs and the timing corresponds with the proposed 
removal and replacement of other measures in the Model.
    Lastly, we considered delaying implementation for all replacement 
measures, such that their Model baseline years would end on December 
31, 2023 and their first performance years would end on December 31, 
2026 (CY 2026 for the OASIS-based DC Function and claims-based PPH 
measures and CY 2025/2026 for the claims-based DTC-PAC measure). Under 
this alternative, the first payment year to use the proposed applicable 
measure set would be CY 2028. We favor the proposed timeline because we 
prefer aligning more closely with the HH QRP measure set as early as 
possible.
6. Future Topics for Measure Considerations
    We will take into consideration opportunities for further alignment 
with measures in the HH QRP and publicly reported on Home Health Care 
Compare because alignment will facilitate comparative assessments of 
provider quality and streamline home health providers' data capture and 
reporting processes. If we consider adding new measures that require 
data that is not already collected through existing quality measure 
data reporting systems, we will propose that option in future 
rulemaking while being mindful of provider burden.
    To further the goals of the CMS National Quality Strategy, CMS 
leaders from across the Agency have come together to move towards a 
building-block approach to streamline quality measure across CMS 
quality programs for the adult and pediatric populations. This 
``Universal Foundation'' \127\ of quality measures will focus provider 
attention, reduce burden, identify disparities in care, prioritize 
development of interoperable, digital quality measures, allow for 
cross-comparisons across programs, and help identify measurement gaps. 
The development and implementation of the Preliminary Adult and 
Pediatric Universal Foundation Measures will promote the best, safest, 
and most equitable care for individuals as we all come together on 
these critical quality areas. As CMS moves forward with the Universal 
Foundation, we will be working to identify foundational measures in 
other specific settings and populations to support further measure 
alignment across CMS programs as applicable.
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    \127\ Jacobs, D.B., Schreiber, M., Seshamani, M., Tsai, D., 
Fowler, E., & Fleisher, L.A. (2023). Aligning quality measures 
across CMS--the universal foundation. New England Journal of 
Medicine, 388(9), 776-779. https://www.nejm.org/doi/full/10.1056/NEJMp2215539.
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    In recognition of persistent health disparities and the importance 
of closing the health equity gap, we will consider future modifications 
that promote health equity and ways in which we could incorporate 
health equity goals into the Model. Any changes would be proposed in 
future notice and comment rulemaking.
    While we are not making any specific proposals here, we invite 
stakeholders to suggest future measures and the value they may provide 
to the expanded HHVBP Model.

C. Proposed Changes to the Appeals Process

1. Background
    As codified at Sec.  484.375, the appeals process under the 
expanded HHVBP

[[Page 43751]]

Model allows HHAs to submit recalculation requests for the interim 
performance reports and the Annual Total Performance Score (TPS) and 
Payment Adjustment Report (Annual Performance Report or APR). Under 
this process, an HHA may also make a reconsideration request if it 
disagrees with the results of a recalculation request for the APR. We 
refer the reader to the CY 2022 HH PPS final rule (86 FR 62331 through 
62332) for details of the appeals process. We also finalized (86 FR 
62329) that we would make available the Final APR after all 
reconsideration requests are processed and no later than 30 calendar 
days before the payment adjustment takes effect annually, both for 
those HHAs that requested a reconsideration and all other competing 
HHAs.
2. Proposed Revisions
    We are proposing revisions to the policy at Sec.  484.375(b)(5) to 
acknowledge the ability of the CMS Administrator to review 
reconsideration decisions, and to change the time for filing a request 
for reconsideration. In particular, we are proposing to amend Sec.  
484.375(b)(5) to specify that an HHA may request Administrator review 
of a reconsideration decision within 7 days from CMS' notification to 
the HHA contact of the outcome of the reconsideration request. We 
propose to amend Sec.  484.375(b)(5) to state that the CMS 
reconsideration official issues a written decision that is final and 
binding 7 calendar days after the decision unless the CMS Administrator 
renders a final determination reversing or modifying the 
reconsideration decision. And, that An HHA may request within 7 
calendar days of the decision that the CMS Administrator review the 
reconsideration decision. The CMS Administrator may decline to review 
the reconsideration decision, render a final determination, or choose 
to take no action on the request for administrative review. 
Reconsideration decisions are considered final if the CMS Administrator 
declines an HHA's request for review or if the CMS Administrator does 
not take any action on the HHA's request for review within 14 days.
    This proposed change would ensure that accountability for the 
decisions of CMS is vested in a principal officer and brings the 
reconsideration review process to a more similar posture as other CMS 
appeals entities that provide Administrator review. This revision also 
ensures that HHAs are aware that administrative review is available to 
those HHAs who wish to seek additional review of a reconsideration 
decision.
    We seek comment on these proposals.

D. Public Reporting Reminder

    In the CY 2022 HH PPS final rule (86 FR 62332 through 62333), we 
finalized that we would publicly report the following information for 
the expanded HHVBP Model:
     Applicable measure benchmarks and achievement thresholds 
for each small- and large-volume cohort.
     For each HHA that qualified for a payment adjustment based 
on the data for the applicable performance year--
     Applicable measure results and improvement thresholds;
     The HHA's Total Performance Score (TPS);
     The HHA's TPS Percentile Ranking; and
     The HHA's payment adjustment for a given year.
    In that same rule, we stated that we anticipate this information 
would be made available to the public on a CMS website on or after 
December 1, 2024, the date by which we would intend to complete the CY 
2023 Annual Report appeals process and issuance of the Final Annual 
Report to each competing HHA. For each year thereafter, we anticipate 
following the same approximate timeline for publicly reporting the 
payment adjustment for the upcoming calendar year. This policy is 
codified at Sec.  484.355(c). We are not proposing any changes to this 
policy. This simply serves as a reminder of our existing policy.

E. Health Equity Update

1. Background
    In the Calendar Year 2023 Home Health Prospective Payment System 
Proposed Rule (CMS-1766-P), we included a Request for Information (RFI) 
on a future approach to health equity in the expanded HHVBP Model. We 
define health equity as ``the attainment of the highest level of health 
for all people, where everyone has a fair and just opportunity to 
attain their optimal health regardless of race, ethnicity, disability, 
sexual orientation, gender identity, socioeconomic status, geography, 
preferred language, or other factors that affect access to care and 
health outcomes.'' \128\ We are working to advance health equity by 
designing, implementing, and operationalizing policies and programs 
that support health for all the people served by our programs and 
models, eliminating avoidable differences in health outcomes 
experienced by people who are disadvantaged or underserved, and 
providing the care and support that our enrollees need to thrive. Our 
goals outlined in the CMS Framework for Health Equity 2022-2032 \129\ 
are in line with Executive Order 13985, ``Advancing Racial Equity and 
Support for Underserved Communities Through the Federal Government.'' 
\130\ The goals included in the CMS Framework for Health Equity serve 
to further advance health equity, expand coverage, and improve health 
outcomes for the more than 170 million individuals supported by our 
programs, and sets a foundation and priorities for our work including: 
strengthening our infrastructure for assessment, creating synergies 
across the health care system to drive structural change, and 
identifying and working to eliminate barriers to CMS-supported 
benefits, services, and coverage.
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    \128\ Centers for Medicare and Medicaid Services. Available at 
https://www.cms.gov/pillar/health-equity. Accessed February 1, 2023.
    \129\ https://www.cms.gov/files/document/cms-framework-health-equity-2022.pdf.
    \130\ https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/20/executive-order-advancing-racial-equity-and-support-for-underserved-communities-through-the-federal-government/.
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    In addition to the CMS Framework for Health Equity, CMS seeks to 
``advance health equity and whole-person care'' as one of eight goals 
comprising the CMS National Quality Strategy (NQS).\131\ The NQS 
identifies a wide range of potential quality levers that can support 
our advancement of equity, including: (1) establishing a standardized 
approach for patient-reported data and stratification; (2) employing 
quality and value-based programs to address closing equity gaps; and, 
(3) developing equity-focused data collection, analysis, regulations, 
and quality improvement initiatives.
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    \131\ Centers for Medicare & Medicaid Services. What is the CMS 
Quality Strategy? Available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/CMS-Quality-Strategy.
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    A goal of this NQS is to address persistent disparities that 
underly our healthcare system. Racial disparities, in particular, are 
estimated to cost the U.S. $93 billion in excess medical costs and $42 
billion in lost productivity per year, in addition to economic losses 
due to premature deaths.\132\ At the same time, racial and ethnic 
diversity has increased in recent years, with an increase in the 
percentage of people who identify as two or more races accounting for 
most of the change, rising from 2.9 percent to

[[Page 43752]]

10.2 percent between 2010 and 2020.\133\ Therefore, we need to consider 
ways to reduce disparities, achieve equity, and support our diverse 
beneficiary population through the way we measure quality and display 
the data.
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    \132\ Ani Turner, The Business Case for Racial Equity, A 
Strategy for Growth, W.K. Kellogg Foundation and Altarum, April 
2018.
    \133\ 2022 National Healthcare Quality and Disparities Report. 
Content last reviewed November 2022. Agency for Healthcare Research 
and Quality, Rockville, MD https://www.ahrq.gov/research/findings/nhqrdr/nhqdr22/index.html.
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    We solicited public comments via the previously discussed RFI on 
policy changes that we should consider on the topic of health equity. 
We specifically requested input on whether we should explore 
incorporating adjustments into the expanded HHVBP Model to reflect the 
varied patient populations that HHAs serve around the country and tie 
equity-focused outcomes to the payment adjustments we make based on HHA 
performance under the Model. We refer readers to the CY 2023 HH PPS 
final rule (87 FR 66876), for a summary of the public comments and 
suggestions we received in response to the health equity RFI. We will 
take these comments into account as we continue to work to develop 
policies and quality measures on this important topic.
2. Anticipated Future State
    We are committed to developing approaches to meaningfully 
incorporate the advancement of health equity into the expanded HHVBP 
Model. As we move this important work forward, we will continue to take 
input from interested parties. We also note that there are proposals 
being made to implement a health equity adjustment in the Hospital 
Inpatient Quality Reporting Program and the SNF Value-Based Purchasing 
Program. At this time, however, we would like to give HHAs time to 
learn the requirements of the expanded Model, gather at least 2 years 
of performance data, and study effects of the expanded Model on health 
equity outcomes before incorporating any potential changes to the 
expanded Model regarding health equity.

V. Medicare Home Intravenous Immune Globulin (IVIG) Items and Services

A. General Background

1. Statutory Background
    Division FF, section 4134 of the CAA, 2023 added coverage and 
payment of items and services related to administration of IVIG in a 
patient's home of a patient with a diagnosed primary immune deficiency 
disease furnished on or after January 1, 2024. Division FF, section 
4134(a) of the CAA, 2023 amended the existing IVIG benefit category at 
section 1861(s)(2)(Z) of the Act by adding coverage for IVIG 
administration items and services in a patient's home of a patient with 
a diagnosed primary immune deficiency disease. This benefit covers 
items and services related to administration of IVIG in a patient's 
home of a patient with a diagnosed primary immune deficiency disease. 
In addition, section 4134(b) of Division FF of the CAA, 2023 amended 
section 1842(o) of the Act by adding a new paragraph (8) that 
established the payment for IVIG administration items and services. 
Under the CAA, 2023 provision, payment for these IVIG administration 
items and services is required to be a bundled payment separate from 
the payment for the IVIG product, made to a supplier for all items and 
services related to administration of IVIG furnished in the home during 
a calendar day.
2. Overview
    Primary immune deficiency diseases (PIDD) are conditions triggered 
by genetic defects that cause a lack of and/or impairment in antibody 
function, resulting in the body's immune system not being able to 
function in a normal way. Immune globulin (Ig) therapy is used to 
temporarily replace some of the antibodies (that is, immunoglobulins) 
that are missing or not functioning properly in people with PIDD.\134\ 
The goal of Ig therapy is to use Ig obtained from normal donor plasma 
to maintain a sufficient level of antibodies in the blood of 
individuals with PIDD to fight off bacteria and viruses. Ig is 
formulated for both intravenous and subcutaneous administration (SCIg). 
Clinicians can prescribe either product to the beneficiary with PIDD 
according to clinical need and preference, and beneficiaries can switch 
between intravenous and subcutaneous administration of Ig.
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    \134\ Perez EE, Orange JS, Bonilla F, et al. (2017) Update on 
the use of immunoglobulin in human disease: A review of evidence; 
Journal Allergy Clin Immunol. 139(3S): S1-S46.
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3. Legislative Summary
    Section 642 of the Medicare Prescription Drug, Improvement, and 
Modernization Act of 2003 (Pub. L. 108-173), amended section 1861 of 
the Act to provide Medicare Part B coverage of the IVIG product for the 
treatment of PIDD in the home, but not the items and services involved 
with administration.
    Section 101 of the Medicare IVIG Access and Strengthening Medicare 
and Repaying Taxpayers Act of 2012 (Medicare IVIG Access Act) (Pub. L. 
112-242), mandated the establishment, implementation, and evaluation of 
a 3-year Medicare Intravenous Immune Globulin (IVIG) Demonstration 
Project (the Demonstration) under Part B of title XVIII of the Act. The 
Demonstration was implemented to evaluate the benefits of providing 
coverage and payment for items and services needed for the home 
administration of IVIG for the treatment of PIDD, and to determine if 
it would improve access to home IVIG therapy for patients with PIDD. 
The Medicare IVIG Access Act mandated that Medicare would establish a 
per visit payment amount for the items and services necessary for the 
home administration of IVIG therapy for beneficiaries with specific 
PIDD diagnoses. The Demonstration did not include Medicare payment for 
the IVIG product which continues to be paid under Part B in accordance 
with section 1842(o) and 1847(A) of the Act. The Demonstration covered 
and paid a per visit payment amount for the items and services needed 
for the administration of IVIG in the home. Items may include infusion 
set and tubing, and services include nursing services to complete an 
infusion of IVIG lasting on average three to five hours.\135\
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    \135\ Updated Interim Report to Congress: Evaluation of the 
Medicare Patient Intravenous Immunoglobulin Demonstration Project, 
2022: https://innovation.cms.gov/data-and-reports/2022/ivig-updatedintrtc.
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    On September 28, 2017, Congress passed the Disaster Tax Relief and 
Airport and Airway Extension Act of 2017 (Pub. L. 115-63). Section 302 
of Public Law 115-63 extended the Demonstration through December 31, 
2020.
    Division CC, section 104, of the Consolidated Appropriations Act, 
2021 (CAA, 2021) (Pub. L. 116-260), further extended the Demonstration 
for another 3 years through December 31, 2023.
    Division FF, section 4134 of the CAA, 2023 (CAA, 2023) (Pub. L. 
117-328) mandated that CMS establish permanent coverage and payment for 
items and services related to administration of IVIG in a patient's 
home of a patient with PIDD. The permanent home IVIG items and services 
payment is effective for home IVIG administration furnished on or after 
January 1, 2024. Payment for these items and services is required to be 
a separate bundled payment made to a supplier for all administration 
items and services furnished in the home during a calendar day. The 
statute provides that payment amount may be based on the amount 
established under the Demonstration. The standard Part B coinsurance 
and the Part B deductible is required to apply. In addition, that 
statute states that the separate bundled

[[Page 43753]]

payment for these IVIG administration items and services does not apply 
for individuals receiving services under the Medicare home health 
benefit. The CAA, 2023 provision clarifies that a supplier who 
furnishes these services meet the requirements of a supplier of medical 
equipment and supplies.
4. Demonstration Overview
    Under the Demonstration, Medicare provides a bundled payment under 
Part B, that is separate from the IVIG product, for items and services 
that are necessary to administer IVIG in the home to enrolled 
beneficiaries who are not otherwise homebound and receiving services 
under the home health benefit. The Demonstration only applies to 
situations where the beneficiary requires IVIG for the treatment of 
certain PIDD diagnoses, or was receiving SCIg to treat PIDD and wishes 
to switch to IVIG.
    Services covered under the Demonstration are required to be 
provided and billed by specialty pharmacies enrolled as durable medical 
equipment (DME) suppliers, that provide the Medicare Part B-covered Ig. 
The covered items and services under the Demonstration are paid as a 
single bundle and are subject to coinsurance and deductible in the same 
manner as other Part B services. HHAs are not eligible to bill for 
services covered under the Demonstration, but can bill for services 
related to the administration of IVIG if the patient is receiving 
services under a home health episode of care, in which case the home 
health payment covers the items and services.
    In order to participate in the Demonstration, beneficiaries must 
meet the following requirements:
     Be eligible to have the IVIG paid for at home under Part B 
FFS
     Have a diagnosis of PIDD
     Not be enrolled in a Medicare Advantage plan
     Cannot be in a home health episode of care on the date of 
service (in such circumstances, the home health payment covers the 
services)
     Must receive the service in their home or a setting that 
is ``home like''.
    To participate in the Demonstration, the beneficiary must submit an 
application, signed by their physician.
    DME suppliers billing for the items and services covered under the 
Demonstration must meet the following requirements:
     Meet all Medicare, as well as other national, state, and 
local standards and regulations applicable to the provision of services 
related to home infusion of IVIG.
     Be enrolled and current with the National Supplier 
Clearinghouse.
     Be able to bill the DME Medicare Administrative 
Contractors (MACs).
    CMS implemented a bundled per visit payment amount under the 
Demonstration, statutorily required to be based on the national per 
visit low-utilization payment adjustment (LUPA) for skilled nursing 
services used under the Medicare HH PPS established under section 1895 
of the Act. The payment amount is subject to coinsurance and 
deductible.
    For billing under the Demonstration, CMS established a ``Q'' code 
for services, supplies, and accessories used in the home under the IVIG 
Demonstration:
     Q2052--(Long Description)--Services, supplies, and 
accessories used in the home under Medicare Intravenous immune globulin 
(IVIG) Demonstration.
     Q2052--(Short Description)--IVIG demo, services/supplies.
    The code is used for the IVIG Demonstration only. Suppliers must 
bill Q2052 as a separate claim line on the same claim for the IVIG 
drug.

B. Proposed Scope of Expanded IVIG Benefit

    As discussed previously, Division FF, section 4134 of the CAA, 
2023, added coverage of items and services related to the 
administration of IVIG in a patient's home, to the existing IVIG 
benefit category at section 1861(s)(2)(Z) of the Act, effective January 
1, 2024. Currently, IVIG is covered in the home under Part B if all of 
the following criteria are met:
     It is an approved pooled plasma derivative for the 
treatment of primary immune deficiency disease.
     The patient has a diagnosis of primary immune deficiency 
disease.
     The IVIG is administered in the home.
     The treating practitioner has determined that 
administration of the IVIG in the patient's home is medically 
appropriate.
    Therefore, as section 4134(a)(1) of the CAA, 2023, adds the items 
and services (furnished on or after January 1, 2024) related to the 
administration of IVIG to the benefit category defined under section 
1861(s)(2)(Z) of the Act (the Social Security Act provision requiring 
coverage of the IVIG product in the home), the same beneficiary 
eligibility requirements for the IVIG product would apply for the IVIG 
administration items and services described in section V.A.4. of this 
proposed rule. Subpart B of Part 410 of the regulations set out the 
medical and other health services requirements under Part B. The 
regulations at Sec.  410.10 identify the services that are subject to 
the conditions and limitations specified in this subpart. Section 
410.10(y) includes intravenous immune globulin administered in the home 
for the treatment of primary immune deficiency diseases. Section 410.12 
outlines general basic conditions and limitations for coverage of 
medical and other health services under Part B, as identified in 
section 410.10. Section 410.12(a) includes the conditions that must be 
met in order for these services to be covered, and include the 
following:
     When the services must be furnished. The services must be 
furnished while the individual is in a period of entitlement.
     By whom the services must be furnished. The services must 
be furnished by a facility or other entity as specified in Sec. Sec.  
410.14 through 410.69.
     Physician certification and recertification requirements. 
If the services are subject to physician certification requirements, 
they must be certified as being medically necessary, and as meeting 
other applicable requirements, in accordance with subpart B of part 
424.
    As the definition of IVIG at section 1861(zz) of the Act now 
includes the items and services necessary to administer IVIG in the 
home, we propose to add the term ``items and services'' to the 
regulation at Sec.  410.10(y). Furthermore, sub-regulatory guidance 
documents (that is, IVIG LCD (33610) \136\ and IVIG Policy Article 
(A52509) \137\) provide direction on coding and coverage for the IVIG 
product at home. Through the Local Coverage Determination (LCD) for 
Intravenous Immune Globulin (L33610),\138\ the Durable Medical 
Equipment Medicare administrative contractors (DME MACs) specify the 
Healthcare Common Procedure Coding System (HCPCS) codes for which IVIG 
derivatives are covered under this benefit. Therefore, a beneficiary 
must be receiving one of the IVIG derivatives specified under the LCD 
for IVIG in order to qualify to receive the items and services covered 
under section 1861(s)(2)(Z) of the Act. Furthermore, for any item 
(including IVIG) to be covered by Medicare, it must (1) be eligible for 
a defined Medicare benefit category, (2) be reasonable and

[[Page 43754]]

necessary for the diagnosis or treatment of illness or injury or to 
improve the functioning of a malformed body member, and (3) meet all 
other applicable Medicare statutory and regulatory requirements. Policy 
guidance for the LCD for IVIG \139\ identifies the ICD-10-CM codes that 
support medical necessity for the provision of IVIG in the home. These 
diagnosis codes are listed in Table E1.
---------------------------------------------------------------------------

    \136\ https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?LCDId=33610.
    \137\ https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=52509.
    \138\ Local Coverage Determination (LCD): IVIG (L33610) https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?LCDId=33610&ContrId=389.
    \139\ https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=52509.
[GRAPHIC] [TIFF OMITTED] TP10JY23.073

    In accordance with this guidance, a beneficiary must be diagnosed 
with one of the primary immune deficiencies identified by the ICD-10-CM 
codes, set out in Table E1 and as updated in subregulatory guidance, in 
order to qualify to receive the items and services covered under 
section 1861(s)(2)(Z) of the Act. This policy guidance is revised as 
needed by the DME MACs. And finally, in order to qualify to receive 
IVIG in the home, section 1861(zz) of the Act requires that a treating 
practitioner must have determined that administration of the IVIG in 
the patient's home is medically appropriate. Accordingly, we intend to 
update the sub-regulatory guidance pursuant to the CAA, 2023 to reflect 
the expansion of the benefit to the items and services related to the 
administration of IVIG at home. Leveraging the existing regulations and 
sub-regulatory guidance would maintain one set of standards across the 
entire IVIG benefit (that is, for the product and for the related items 
and services). This would result in seamless implementation from the 
existing IVIG Demonstration, thereby ensuring immediate access for 
beneficiaries requiring such items and services. We solicit comments on 
our proposal to add ``items and services'' to the regulation at Sec.  
410.10(y).
1. Items and Services Related to the Home Administration of IVIG
    Section 101(c) of the Medicare IVIG Access Act established coverage 
for items and services needed for the in-home administration of IVIG 
for the treatment of primary immunodeficiencies under a Medicare 
demonstration program. We interpret section 4134 of the CAA, 2023 to 
make permanent coverage of the same items and services under the 
existing IVIG Demonstration in order to ensure continuous and 
comprehensive coverage for beneficiaries who choose to receive home 
IVIG therapy. Under the Demonstration, the bundled payment for the 
items and services necessary to administer the drug intravenously in 
the home includes the infusion set and tubing, and nursing services to 
complete an infusion of IVIG lasting on average three to five 
hours.\140\ Although ``items and services'' are not explicitly defined 
under section 4134 of the CAA, 2023, we believe the items and services 
covered under the Demonstration are inherently the same items and 
services that would be covered under the payment added to the benefit 
category at section 1861(s)(2)(Z) of the Act. While

[[Page 43755]]

we are not enumerating a list of services that must be included in the 
separate bundled payment, we anticipate that the nursing services would 
include such professional services as IVIG administration, assessment 
and site care, and education. Moreover, it is up the provider to 
determine the services and supplies that are appropriate and necessary 
to administer the IVIG for each individual. This may or may not include 
the use of a pump. Because IVIG does not have to be administered 
through a pump (although it can be), external infusion pumps are not 
covered under the DME benefit for the administration of IVIG. An 
external infusion pump is only covered under the DME benefit if the 
infusion pump is necessary to safely administer the drug. The Local 
Coverage Determination (LCD) for External Infusion Pumps identify the 
drugs and biologicals that the DME Medicare Administrative Contractors 
(MACs) have determined require the use of such pumps and cannot be 
administered via a disposable elastomeric pump or the gravity drip 
method.\141\ As such, under the IVIG Demonstration, coverage does not 
extend to the DME pump, and thereby, would not be covered separately 
under the home IVIG items and services payment.
---------------------------------------------------------------------------

    \140\ Updated Interim Report to Congress: Evaluation of the 
Medicare Patient Intravenous Immunoglobulin Demonstration Project, 
August 2022 found at: https://innovation.cms.gov/data-and-reports/2022/ivig-updatedintrtc.
    \141\ https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?LCDId=33794.
---------------------------------------------------------------------------

    We invite comments on any additional interpretations of items and 
services that may be considered under the scope of the home IVIG 
benefit.
2. Home IVIG Items and Services and the Relationship to/Interaction 
With Home Health and Home Infusion Therapy Services
    Prior to enactment of the CAA, 2023, IVIG administration items and 
services were explicitly excluded from coverage under the Part B IVIG 
benefit. However, if a beneficiary was considered homebound and 
qualified for the home health benefit, the items and services needed to 
administer IVIG in the home could be covered as home health services. 
Section 4134(b) of the CAA, 2023 excludes the IVIG items and services 
bundled payment in the case of an individual receiving home health 
services under section 1895 of the Act. Therefore, a beneficiary does 
not have to be considered confined to the home (that is, homebound) in 
order to be eligible for the home IVIG benefit; however, homebound 
beneficiaries requiring items and services related to the 
administration of home IVIG, and who are receiving services under a 
home health plan of care, may continue to receive services related to 
the administration of home IVIG as covered home health services. As 
such, in the case that a beneficiary is receiving home health services 
under the home health benefit, the home health agency could continue to 
bill for these items and services under the home health benefit and the 
drug would be continued to be paid under Part B. A separate payment for 
the IVIG items and services under the IVIG benefit would be prohibited.
    With regard to the home infusion therapy (HIT) services benefit, 
Medicare payment for home infusion therapy services is for services 
furnished in coordination with the furnishing of intravenous and 
subcutaneous infusion drugs and biologicals specified on the DME LCD 
for External Infusion Pumps (L33794),\142\ with the exception of 
insulin pump systems and certain drugs and biologicals on a self-
administered drug exclusion list. In order for the drugs and 
biologicals to be covered under the Part B DME benefit they must 
require infusion through an external infusion pump. If the drug or 
biological can be infused through a disposable pump or by a gravity 
drip, it does not meet this criterion. IVIG does not require an 
external infusion pump for administration purposes and therefore, is 
explicitly excluded from the DME LCD for External Infusion Pumps. 
However, subcutaneous immunoglobulin (SCIg) is covered under the DME 
LCD for External Infusion Pumps, and items and services for 
administration in the home are covered under the HIT services benefit. 
While a DME supplier and a HIT supplier (or a DME supplier also 
enrolled as a HIT supplier) could not furnish services related to the 
administration of immunoglobulin (either IVIG or SCIg) to the same 
beneficiary on the same day, a beneficiary could potentially receive 
services under both benefits for services related to the infusion of 
different drugs. For example, a DME supplier also accredited and 
enrolled as a HIT supplier, could furnish HIT services to a beneficiary 
receiving intravenous acyclovir as well as IVIG, and bill both the IVIG 
and the HIT services benefits on the same date of service. We also 
recognize that a beneficiary may, on occasion, switch from receiving 
immunoglobulin subcutaneously to intravenously and vice versa, and as 
such, utilize both the HIT services and the IVIG benefits within the 
same month. We invite comments on how typical it is for a patient to 
alternate between receiving IVIG and SCIg and the frequency with which 
it may occur.
---------------------------------------------------------------------------

    \142\ Local Coverage Determination (LCD): External Infusion 
Pumps (L33794) https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?LCDId=33794.
---------------------------------------------------------------------------

C. Proposed IVIG Administration Items and Services Payment

    As discussed previously, section 101 of the Medicare IVIG Access 
Act established the authority for a Demonstration providing payment for 
items and services needed for the in-home administration of IVIG. We 
believe the provisions established under that law serve as the basis 
for the conditions for payment with respect to the requirements that 
must be met for Medicare payment to be made to suppliers for the items 
and services covered under section 1861(s)(2)(Z) of the Act.
1. Home IVIG Administration Items and Services Supplier Type
    Section 4134(b) of the CAA, 2023 amends section 1842(o) of the Act 
by adding a new paragraph (8) that establishes a separate bundled 
payment to the supplier for all items and services related to the 
administration of such intravenous immune globulin, described in 
section 1861(s)(2)(Z) of the Act to such individual in the patient's 
home during a calendar day. Section 4134(c) of the CAA, 2023 amends 
section 1834(j)(5) of the Act, which are a requirement for supplier of 
medical equipment and supplies, by adding a new subparagraph (E), 
clarifying with respect to payment, that items and services related to 
the administration of intravenous immune globulin furnished on or after 
January 1, 2024, as described in section 1861(zz) of the Act, are 
included in the definition of medical equipment and supplies. This 
means that suppliers that furnish IVIG administration items and 
services must meet the existing DMEPOS supplier requirement for payment 
purposes under this benefit. Suppliers of IVIG administration items and 
services must enroll as a DMEPOS supplier and comply with the Medicare 
program's DMEPOS supplier standards (found at 42 CFR 424.57(c)) and 
DMEPOS quality standards to become accredited for furnishing medical 
equipment and supplies. Further, in order to receive payment for home 
IVIG items and services, the supplier must also meet the requirements 
under subpart A of Part 424--Conditions for Medicare Payment. The 
DMEPOS supplier may subcontract with a provider in order to meet the 
professional services identified in section V.B.1. of this proposed 
rule. All professionals who furnish services directly, under an 
individual contract,

[[Page 43756]]

or under arrangements with a DMEPOS supplier to furnish services 
related to the administration of IVIG in the home, must be legally 
authorized (licensed, certified, or registered) in accordance with 
applicable Federal, State, and local laws, and must act only within the 
scope of their State license or State certification, or registration. A 
supplier may not contract with any entity that is currently excluded 
from the Medicare program, any State health care programs or from any 
other federal procurement or non-procurement programs.
2. Home IVIG Administration
    Section 1861(s)(2)(Z) of the Act defines benefit coverage of 
intravenous immune globulin for the treatment of primary immune 
deficiency diseases in the home. Under the IVIG Demonstration, 
beneficiaries are eligible to participate if they receive IVIG services 
in ``their home or a setting that is `home like' \143\ ''. Section 
410.12(b) identifies the supplier types who can furnish the services 
identified at Sec.  410.10. Section 410.38 provides the conditions for 
payment for DME suppliers and identifies the institutions that may not 
qualify as the patient's home. As such, the home administration of IVIG 
items and services must be furnished in the patient's home, defined as 
a place of residence used as the home of an individual, including an 
institution that is used as a home. An institution that is used as a 
home may not be a hospital, CAH, or SNF as defined in Sec.  410.38(b).
---------------------------------------------------------------------------

    \143\ Intravenous Immune Globulin Demonstration MLN Fact Sheet: 
https://www.cms.gov/files/document/mln3191598-intravenous-immune-globulin-demonstration.pdf.
---------------------------------------------------------------------------

D. Proposed Home IVIG Items and Services Payment Rate

1. Proposed Payment Amount for Home IVIG Items and Services for CY 2024
    Section 1842(o) of the Act provides the authority for the 
development of a separate bundled payment for Medicare-covered items 
and services related to the administration of intravenous immune 
globulin to an individual in the patient's home during a calendar day, 
in an amount that the Secretary determines to be appropriate. This 
payment may be based on the payment established pursuant to section 
101(d) of the Medicare IVIG Access Act. Section 4134(d) of the CAA, 
2023, amends section 1833(a)(1) of the Act to provide that, with 
respect to items and services related to the administration of IVIG 
furnished on or after January 1, 2024, as described in section 1861(zz) 
of the Act, the amounts paid shall be the lesser of the 80 percent of 
the actual charge or the payment amount established under section 
1842(o)(8).
    In accordance with section 101(d) of the Medicare IVIG Access Act, 
the Secretary established a per visit payment amount for the items and 
services needed for the in-home administration of IVIG based on the 
national per visit low-utilization payment amount (LUPA) under the 
prospective payment system for home health services established under 
section 1895 of the Social Security Act. Per the Demonstration, the 
bundled payment amount for services needed for the home administration 
of IVIG includes infusion services provided by a skilled nurse. 
Therefore, the bundled payment is based on the LUPA amount for skilled 
nursing, based on an average 4-hour infusion. The initial payment rate 
for the first year of the Demonstration, was based on the full skilled 
nursing LUPA for the first 90 minutes of the infusion and 50 percent of 
the LUPA for each hour thereafter for an additional 3 hours. 
Thereafter, the payment rate is annually updated based on the nursing 
LUPA rate for such year. The service is subject to coinsurance and 
deductibles similar to other Part B services.
    As we noted in sectionV.B.1. of this proposed rule, we believe that 
payment under section 1861(s)(2)(Z) of the Act covers the same items 
and services covered under the IVIG Demonstration. Likewise, we also 
agree that the professional services needed to safely administer IVIG 
in the home would be services furnished by a registered nurse. 
Therefore, we believe setting the CY 2024 payment rate for the home 
IVIG items and services under section 1861(s)(2)(Z) of the Act, based 
on the CY 2023 payment amount established under the Demonstration 
($408.23) is appropriate. However, although the Demonstration used the 
LUPA rate, which is annually adjusted by the wage index budget 
neutrality factor, as well as the home health payment rate update 
percentage, we believe it is appropriate to propose to update the CY 
2023 IVIG services Demonstration rate by only the CY 2024 home health 
payment rate update percentage and not include the wage index budget 
neutrality factor, as the IVIG items and services payment rate is not 
statutorily required to be geographically wage adjusted. Therefore, the 
proposed home IVIG items and services payment rate for CY 2024 would be 
$408.23*1.027 = $419.25.
    Further, although section 1842(o) of the Act states that payment is 
for the items and services furnished to an individual in the patient's 
home during a calendar day, we believe that, as the statute aligns the 
payment amount with such amount determined under the Demonstration, the 
best reading of ``calendar day'' is ``per visit.'' Additionally, we 
would expect a supplier to furnish only one visit per calendar day.
    We propose to establish a new Subpart R under the regulations at 42 
CFR part 414 to incorporate payment provisions for the implementation 
of the IVIG items and services payment in accordance with section 
1842(o) of the Act for home IVIG items and services furnished on or 
after January 1, 2024. We propose at Sec.  414.1700(a), that a single 
payment amount is made for items and services furnished by a DMEPOS 
supplier per visit. We propose at Sec.  414.1700(b), to set the initial 
payment amount equivalent to the CY 2023 ``Services, Supplies, and 
Accessories Used in the home under the Medicare IVIG Demonstration'' 
payment amount, updated by the proposed CY 2024 home health update 
percentage of 2.7 percent. We are soliciting comments on these payment 
proposals, including the proposed CY 2024 payment rate.
(a) Proposed Annual Payment Update
    As discussed previously, the IVIG Demonstration used the nursing 
LUPA rate, which is annually adjusted by the wage index budget 
neutrality factor, as well as the home health update percentage, as the 
payment rate for such year of services. Because the IVIG services 
payment is not geographically wage adjusted, we believe it is more 
appropriate to annually adjust the IVIG items and services payment rate 
only by the home health payment update percentage. As such we propose 
at Sec.  414.1700(c), beginning in 2025, the per-visit payment amount 
from the prior year will be annually increased by the home health 
update percentage for the current calendar year. We solicit comments on 
the use of the home health update percentage to annually update the 
IVIG items and services payment beyond CY 2024.

E. Billing Procedures for Home IVIG Items and Services

    In order to ensure a smooth transition for DME suppliers to bill 
for the items and services related to the home administration of IVIG, 
we will use the existing Q-code (Q2052) under the Demonstration, with a 
new descriptor (``Services, Supplies, and Accessories used in the Home 
for the Administration of Intravenous Immune Globulin'') in order to 
bill for items and services under Medicare FFS. The Q-

[[Page 43757]]

code would continue to be billed separately from, or on the same claim 
as, the J-code for the IVIG product and would be processed through the 
DME MACs. The Q-code should be billed as a separate claim line on the 
same claim for the same place of service as the J-code for the IVIG. In 
cases where the IVIG product is mailed or delivered to the patient 
prior to administration, the date of service for the administration of 
the IVIG (the Q-code) may be no more than 30 calendar days after the 
date of service on the IVIG product claim line. No more than one Q-code 
should be billed per claim line per date of service.
    If a provider is billing for multiple administrations of IVIG on a 
single claim, then the supplier would bill the Q-code for each date of 
service on a separate claim line, which would be payable per visit 
(that is, each time the IVIG is administered). There may be situations 
in which multiple units of IVIG are shipped to the patient and billed 
on a single ``J'' code claim line followed by more than one Q-code 
administration claim line, each with the date of service on which the 
IVIG was administered. However, only one Q-code shall be paid per 
infusion date of service. In order to implement the requirements for 
this separate bundled payment under section 1861(s)(2)(Z) of the Act, 
we would issue a Change Request (CR) prior to implementation of this 
payment, including the Q-code needed for billing, outlining the 
requirements for the claims processing changes needed to implement this 
payment.

VI. Hospice Informal Dispute Resolution and Special Focus Program

A. Background and Statutory Authority

    Division CC, section 407 of the Consolidated Appropriations Act of 
2021 (CAA), 2021, amended Part A of Title XVIII of the Act to add a new 
section 1822, and amended sections 1864(a) and 1865(b) of the Act, 
establishing new hospice program survey and enforcement requirements, 
required public reporting of survey information, and a new hospice 
hotline.
    The provisions in the CAA, 2021 direct the Secretary to create a 
Special Focus Program (SFP) for poor-performing hospice programs, give 
authority for imposing enforcement remedies for noncompliant hospice 
programs, and require the development and implementation of a range of 
remedies as well as procedures for appealing determinations regarding 
these remedies. These enforcement remedies can be imposed instead of, 
or in addition to, termination of the hospice programs' participation 
in the Medicare program. The remedies include civil money penalties 
(CMP), directed in-service training, directed plan of correction, 
suspension of all or part of payments, and appointment of temporary 
management to oversee operations.
    In the CY 2022 HH PPS final rule (86 FR 62240), we addressed 
provisions related to hospice survey enforcement and other activities 
described in the rule. A summary of the finalized CAA, 2021 provisions 
regarding hospice survey and enforcement can be found in the CY 2022 HH 
PPS final rule (86 FR 62243), available at https://www.govinfo.gov/content/pkg/FR-2021-11-09/pdf/2021-23993.pdf. We finalized all the CAA, 
2021 provisions related to hospice survey and enforcement in CY 2022 
rulemaking except for the SFP. As outlined in the CY 2022 HH PPS final 
rule, we stated that we would consider public comments we received and 
seek additional collaboration with stakeholders to further develop a 
revised proposal and methodology for the SFP.
    In the FY 2023 Hospice Wage Index and Payment Rate Update and 
Hospice Quality Reporting Requirements final rule (87 FR 4566) (Hospice 
rule), we affirmed our intention to initiate a hospice Technical Expert 
Panel (TEP) to provide input on the structure and methodology of the 
SFP. Public comments received in response to the FY 2023 Hospice rule 
generally supported CMS's efforts to establish an SFP and to convene a 
TEP as part of the SFP development. A 30-day call for nominations was 
held July 14 through August 14, 2022, and nine TEP members were 
selected, representing a diverse range of experience and expertise 
related to hospice care and quality. A CMS contractor convened a TEP in 
October and November 2022, which provided feedback and considerations 
on the preliminary SFP concepts, including developing a methodology to 
identify hospice poor-performers, criteria for completing the SFP and 
for termination from Medicare when a hospice cannot complete the SFP, 
and public reporting. Details from the TEP meetings, including their 
recommendations, are available in the TEP summary report \144\ on the 
CMS website at https://www.cms.gov/medicare/quality-safety-oversight-certification-compliance/hospice-special-focus-program.
---------------------------------------------------------------------------

    \144\ 2022 Technical Expert Panel and Stakeholder Listening 
Sessions: Hospice Special Focus Program Summary Report (April 28, 
2023).
---------------------------------------------------------------------------

B. Proposed Regulatory Provisions

1. Overview
    In this proposed rule, we are proposing in Subpart M--Survey and 
Certification of Hospice Programs, to add new definitions of ``Hospice 
Special Focus Program,'' ``IDR,'' ``SFP status,'' and ``SFP survey'' at 
Sec.  488.1105. We are also proposing a hospice informal dispute 
resolution process at Sec.  488.1130 to provide hospice programs an 
informal opportunity to resolve disputes related to condition-level 
survey findings for those hospice programs that are seeking 
recertification from the State survey agency (SA), CMS, or 
reaccreditation from the accrediting organization (AO) for continued 
participation in Medicare. Informal dispute resolution would also be 
offered to hospice programs following a complaint or validation survey 
and those in the SFP. We are proposing the specific details on the 
hospice SFP at Sec.  488.1135, which includes the criteria for 
selection and completion of the SFP, hospice termination from Medicare, 
and public reporting of the SFP. We are proposing that the hospice SFP 
will commence as of the effective date of the rule, and we anticipate 
selecting SFP hospices in CY 2024. We also propose to periodically 
review the effectiveness of the methodology and the algorithm.
2. Proposed Definitions (Sec.  488.1105)
    We propose to add four new definitions to Sec.  488.1105, that 
would define the hospice SFP, IDR, SFP status, and SFP survey. The 
definitions proposed for hospice programs are as follows:
     Hospice Special Focus Program (SFP) means a 
program conducted by CMS to identify hospices as poor performers, based 
on defined quality indicators, in which CMS selects hospices for 
increased oversight to ensure that they meet Medicare requirements. 
Selected hospices either successfully complete the SFP program or are 
terminated from the Medicare program.
     IDR stands for informal dispute resolution.
     SFP status means the status of a hospice 
provider in the SFP with respect to the provider's standing in the SFP, 
which is indicated by one of the following status levels: Level 1--in 
progress; Level 2--completed successfully; or Level 3--terminated from 
the Medicare program.
     SFP survey refers to a standard survey as 
defined in Sec.  488.1105 and is performed after a hospice is selected 
for the SFP and is conducted every 6 months, up to three occurrences.

[[Page 43758]]

3. Informal Dispute Resolution (Sec.  488.1130)
    We propose at new Sec.  488.1130 to make an Informal Dispute 
Resolution (IDR) process available to hospice programs to address 
disputes related to condition-level survey findings following a hospice 
program's receipt of the official survey Statement of Deficiencies and 
Plan of Correction, Form CMS-2567. The proposed IDR for hospices would 
be similar to the process already in existence for home health 
agencies. The proposed IDR process for hospice programs, like that of 
HHAs, is for condition-level survey findings which may be the impetus 
for an enforcement action. Standard-level findings alone do not trigger 
an enforcement action and are not accompanied by appeal and hearing 
rights. The proposed IDR process would provide hospice programs an 
informal opportunity to resolve disputes regarding survey findings for 
those hospice programs seeking recertification from the SA, CMS, or 
reaccreditation from the AO for continued participation in Medicare. 
Additionally, proposed IDR may be initiated for programs under SA 
monitoring (either through a complaint investigation or validation 
survey) and those in the proposed SFP. For hospice programs deemed 
through a CMS-approved AO, the AO would receive the IDR request from 
their deemed facility program, following the same process and 
coordinating with CMS regarding any enforcement actions. In accordance 
with 42 CFR 488.5(a)(4), AOs must have a comparable survey process to 
the SAs. For deemed hospice programs, the AO communicates any 
condition-level findings to the applicable CMS Location. If a deemed 
hospice fails to meet the Medicare requirements or shows continued 
condition-level noncompliance, deemed status is generally removed and 
oversight is placed under the SA. The purpose of the proposed IDR 
process would be to provide an opportunity to settle disagreements at 
the earliest stage, prior to a formal hearing, and to conserve time and 
money resources potentially spent by the hospice, the SA, and CMS. The 
proposed IDR process may not be used to refute an enforcement action or 
selection into the SFP. Additionally, we propose that failure of CMS, 
or the State or the AO, as appropriate, to complete IDR must not delay 
the effective date of any enforcement action.
    When survey findings indicate a condition-level deficiency (or 
deficiencies), the hospice program would be notified in writing of its 
opportunity to request an IDR for those deficiencies. This notice will 
would be provided to the hospice program when the CMS-2567 Statement of 
Deficiencies and Plan of Correction is issued to the hospice. We 
propose that the hospice's request for IDR must be submitted in writing 
(electronically or hard copy), include the specific survey findings 
that are disputed, and be submitted within the same 10 calendar days 
allowable for submitting an acceptable plan of correction.
    The proposed IDR provision balances the need for hospice programs 
to avoid unnecessary disputes and protracted litigation using the most 
rapid mechanism for correcting deficiencies and aligning with the 
interests of hospice patients/caregivers. IDR is meant to be an 
informal process whereby the provider has an opportunity to address the 
surveyor's findings, either by disputing them or providing additional 
information.
    We propose that if any survey findings are revised or removed by 
the State or CMS based on IDR, and if CMS accepts the IDR results, the 
CMS-2567 would be revised accordingly. If CMS accepts the IDR results 
and the revised Form CMS-2567, then CMS would adjust any enforcement 
actions imposed solely due to those cited and revised deficiencies. If 
the survey findings are upheld by CMS or the state following IDR, the 
Form CMS-2567 would not be revised based on the IDR and there would not 
be adjustments to the enforcement actions.
4. Special Focus Program (Sec.  488.1135)
    Section 1822(b) of the Act requires the Secretary to conduct a 
Special Focus Program for hospice programs that the Secretary has 
identified as having substantially failed to meet applicable 
requirements of the Act. We propose at Sec.  488.1135 a hospice SFP to 
address issues that place hospice beneficiaries at risk for poor 
quality of care through increased oversight. We propose that specific 
criteria would be used to determine whether a hospice program 
participates in the SFP as outlined in the proposed rule. We also 
propose the proposed hospice SFP would commence as per the effective 
date of the final rule when published, and we anticipate selecting SFP 
hospices starting in CY 2024. We propose to periodically review the 
effectiveness of the methodology and the algorithm and make adjustments 
through rulemaking as necessary.
a. Proposed Hospice Special Focus Program Algorithm
    In establishing the proposed Hospice SFP, we examined the Special 
Focus Facility program for nursing homes and its methodology for 
facility selection. Although the proposed methodology for the hospice 
program SFP is similar in certain facets, the proposed SFP methodology 
is tailored specifically to this setting and to the data that is 
available to evaluate hospice performance.
    We propose to identify a subset of 10 percent of hospice programs 
based on the highest aggregate scores determined by the algorithm. The 
hospices selected for the SFP from the 10 percent would be determined 
by CMS.
    To identify ``poor performance,'' we have identified several 
indicators, namely, survey reports with Condition-Level Deficiencies 
(CLDs) and complaints with substantiated allegations, and CMS Medicare 
data sources from the Hospice Quality Reporting Program (HQRP) 
(Medicare claims and Consumer Assessment of Healthcare Providers and 
Systems (CAHPS[supreg]) Hospice Survey). These indicators, which can be 
used to identify potential poor performance, have been integrated into 
the proposed SFP algorithm to assist in identifying potential hospice 
providers for the SFP.
    As discussed previously, we propose to use multiple data sources to 
provide a comprehensive view of the quality of care provided at the 
identified hospices. The compilation of these data sources illustrates 
areas of concern--validated/identified issues based on in-person/on-
site review of a hospice to meet Medicare requirements; caregiver and 
public complaints about hospices not providing quality of care or not 
meeting Medicare requirements; and quality measures that inform the 
public of whether a hospice is providing expected care processes or 
outcomes. We believe these are indicators of poor quality hospice care. 
The proposed SFP algorithm is designed as an initial step in 
identifying poor quality indicators.
b. Proposed Use of Medicare Data Sources To Identify Poor Performing 
Hospices
    To identify hospices with poor quality indicators, we propose using 
the most recent complete Medicare hospice data from two data sources: 
(1) hospice surveys; and (2) Medicare HQRP. Each source represents 
distinct dimensions of hospice care that we have identified as related 
to a hospice's performance or practices. From these data sources, we 
propose using multiple indicators of

[[Page 43759]]

hospice care delivery to identify poor performing hospices (see Table 
1). Hospices would be identified for potential SFP enrollment if they--
(1) have data from any of the aforementioned data sources; (2) are 
listed as an active provider (that is, have billed at least one claim 
to Medicare FFS in the last 12 months); and (3) operate in the United 
States, including the District of Columbia and U.S. territories. Each 
data source and the proposed quality indicators are discussed further 
later in this preamble. Based on these proposed criteria, in CY 2019 
through CY 2021 analytic file, 5,943 hospices would be eligible for 
participation in the SFP.
[GRAPHIC] [TIFF OMITTED] TP10JY23.074

(1) Hospice Survey Data
(a) Quality-of-Care Condition-Level Deficiencies (CLDs)
    Hospices are surveyed for compliance with hospice program 
requirements prior to becoming certified as a hospice provider in 
Medicare (initial certification survey) and then at least once every 36 
months (standard survey for recertification (Sec.  418.1110)), with 
roughly one-third of all hospices being surveyed each year. A post-
survey revisit or follow-up survey may also occur to determine if the 
hospice corrected cited deficiencies. Hospice survey data (initial 
certification, standard recertification, and follow-up) is collected on 
the Certification And Survey Provider Enhanced Reports (CASPER) system. 
CMS will be posting publicly available hospice survey finding 
information to the Quality, Certification and Oversight Report (QCOR) 
website in CY 2023. For information related to the hospice survey 
process, we encourage the public to review the CMS State Operations 
Manual (SOM), Appendix M (internet Only Publication 100-07).
    A CLD is cited on a survey when a hospice is found to be 
noncompliant with all or part of a condition of participation (CoP), 
which is one of the health and safety requirements all hospices are 
required to meet to participate in Medicare. As discussed in the QSOG 
memo (QSO-23-08-hospice) issued on January 27, 2023, a significant 
change in the hospice survey protocol was made to provide an enhanced 
approach to investigating the quality-of-care provided to hospice 
patients. While each of the 23 CoPs continues to have equal weight in 
the final certification decision, special attention is directed to 
those CoPs directly impacting patient care for purposes of the proposed 
SFP. Consistent with this enhanced survey process, we have identified 
11 quality-of-care CoPs that directly contribute to the quality-of-care 
delivered to patients, their caregivers, and families, and believe that 
a cited CLD on any one of them may indicate a hospice is providing poor 
quality-of-care. Therefore, we propose to include the 11 quality-of-
care CLDs noted in Table F2) as data indicators in the SFP algorithm. 
The SFP algorithm would focus on quality-of-care CLDs because they are 
based on observable quality concerns seen and reported by hospice 
surveyors to identify hospices that provide poorer quality-of-care to 
hospice patients. Additionally, we did not include all 23 hospice CoPs 
because we did not want to dilute the methodology's ability to identify 
quality concerns. However, we may explore incorporating other CoPs into 
the methodology, and we solicit comments on an alternative approach 
that would incorporate other CoPs in the calculation for the SFP 
algorithm.
[GRAPHIC] [TIFF OMITTED] TP10JY23.075


[[Page 43760]]


    We propose to count the total number of quality-of-care CLDs from 
the previous 3 consecutive years of data. Our analysis of data from CY 
2019 through 2021 found that very few hospices are not present in the 
survey data, and that the overwhelming majority of hospices (88.3 
percent of all proposed SFP-eligible hospices or 5,248 out of 5,943) 
had no quality-of-care CLDs cited over these 3 years. Of the 5,943 
hospices identified that would be SFP-eligible under the CY 2019-2021 
data, 5.7 percent (that is, 341 hospices) are not present in the survey 
data. This means that each of those 341 hospices has not yet received 
its standard survey or their survey results had not been recorded as of 
the time the data was accessed for analysis from the CASPER system and/
or had no recorded substantiated complaint in the internet Quality 
Improvement and Evaluation System (iQIES). Considering public comments 
received on the CY 2022 HH PPS final rule (86 FR 62240) and the SFP TEP 
feedback, stakeholders expressed concern about inter-surveyor 
reliability and state-to-state variability in survey policy as 
potential drawbacks of including survey data as part of the SFP program 
methodology. However, the TEP also acknowledged the importance and 
value of survey data that identifies whether a hospice complies with 
Medicare requirements to support basic care quality. Furthermore, the 
TEP supported using the total count of quality-of-care CLDs to indicate 
significant noncompliance with multiple CoPs. To address the inter-
surveyor reliability and variability concerns, we have implemented 
improvements to surveyor training guidelines to increase surveyor 
standardization between SAs and AOs. Based on our efforts to improve 
surveyor training, and considering the TEP and stakeholder concerns, we 
propose counting the total number of quality-of-care CLDs from the last 
3 consecutive years of data.
(b) Substantiated Complaints
    In addition to quality-of-care CLDs, we propose to include the 
total number of substantiated complaints received against a hospice in 
the last 3 consecutive years of data before the release of the SFP 
selection list. Complaints against a hospice may be filed with the SA 
or Beneficiary and Family Centered Care Quality Improvement 
Organization at any time by a patient and/or caregiver(s) and hospice 
staff members (Medicare SOM Chapter 5). Once a complaint is filed with 
the SA, the SA can conduct an unannounced complaint investigation 
survey to substantiate or refute the complaint. If the allegation is 
found to be substantiated or confirmed, the SA informs the hospice and 
submits the findings to iQIES. A post-survey revisit or follow-up 
survey may also occur to determine if the hospice has made corrections 
and is in compliance with all requirements. A hospice may have many 
complaints filed against them, but not all complaints may be 
substantiated upon SA review. The results of the review of complaints 
are submitted to the iQIES system, which is not publicly available. 
Like quality-of-care CLDs, most hospices in our analysis currently have 
no substantiated complaints in the identified 3-year period. Our CY 
2019-2021 survey data analysis found that currently 81.8 percent of 
hospice programs (that is,4,860 of the 5,943 SFP-eligible hospices) 
have had no substantiated complaints over the past 3 years. As noted 
previously, there are 5.7 percent of eligible hospices that have no 
survey data, or in other words, there is missingness in the survey data 
for those hospices. Unlike quality-of-care CLDs, where missingness is 
likely due to the absence of a recent survey, the absence of 
substantiated complaints from this data is likely because the hospice 
program has no substantiated complaints.
(2) Hospice Quality Reporting Program (HQRP) Data
    In addition to survey data, we propose to use quality measures from 
the Hospice Quality Reporting Program (HQRP) to capture hospice care 
processes and beneficiary/caregiver care experiences. The HQRP includes 
data submitted by hospices via the Hospice Item Set (HIS), Medicare 
hospice claims, and the CAHPS Hospice Surveys. All Medicare-certified 
hospices must comply with these reporting requirements or face 
penalties for a failure to report, although some hospices may be exempt 
from reporting certain measures.\145\ This ensures that most hospices 
have these data available for use in the SFP algorithm. These quality 
measure data are publicly available in the Provider Data Catalog (PDC) 
at https://data.cms.gov/provider-data/topics/hospice-care and Care 
Compare at https://www.medicare.gov/care-compare/?providerType=Hospice. 
A description of current HQRP measures and public reporting dates is 
available online. We propose to include five publicly reported HQRP 
measures to identify poor performing hospices. The proposed measures 
are as follows:
---------------------------------------------------------------------------

    \145\ Information on the reporting requirements and Annual 
Payment Update payment penalties for the failure to report can be 
found on the HQRP Overview website or section 1814(i) of the Act.

 Medicare claims-based measure:--Hospice Care Index (HCI) 
Overall Score
 CAHPS Hospice Survey Data measures:
++ Help for Pain and Symptoms
++ Getting Timely Help
++ Willingness to Recommend this Hospice
++ Overall Rating of this Hospice
(a) Hospice Care Index (HCI)
    We propose including the HCI overall score based on eight quarters 
of Medicare claims data. The HCI captures multiple aspects of care 
delivery across ten indicators that comprise a composite HCI overall 
score, with hospices earning a point for each indicator met (range: 0-
10 such that a lower score indicates lower quality of care). The 
proposed HCI overall score indicates hospice care quality between 
admission and discharge (HCI Technical Report). Moreover, the HCI score 
is based on Medicare claims data, which provide direct evidence of care 
delivery decisions at a hospice that is readily available for all 
hospices. For public reporting, hospices with less than 20 claims over 
the eight quarters are excluded from reporting the measure. The HCI 
measure would also be suppressed if any 1 of the 10 indicators is not 
reported for any reason. Additional details of the HCI, such as the 
quality measure specifications, data period, and exclusion criteria, 
are available in the HQRP Quality Measure (QM) User's Manual posted on 
the HQRP Current Measures web page. The TEP and previous public 
comments generally supported the inclusion of HCI data in the 
preliminary methodology because the HCI captures a robust majority of 
hospices participating in Medicare and covers key aspects of the 
hospice care continuum. Our analysis of FYs 2019 to 2021 (excluding 
January through June 2020) HCI data found that 78.3 percent of hospice 
programs (that is, 4,656 of the 5,943 SFP-eligible hospices) had a 
publicly reported HCI score. The overwhelming majority of those 
hospices receive an HCI score of 8 or more out of 10--4,007 (86.1 
percent) of the 4,656 SFP eligible hospices with an HCI score reported.
(b) CAHPS Hospice Survey
    To represent decedent/caregiver experience of hospice care, and in 
consideration of TEP and stakeholder perspectives, we propose using 
four measures from the CAHPS Hospice Survey: (1) help for pain and 
symptoms;

[[Page 43761]]

(2) getting timely help; (3) willingness to recommend the hospice; and 
(4) overall rating of the hospice. CAHPS Hospice Survey measure scores 
are calculated across eight rolling quarters for all hospices with at 
least 30 completed surveys. Some hospices do not participate in CAHPS 
as new hospices are exempt from reporting CAHPS measures for the 
calendar year in which they receive their CMS Certification Number 
(CCN), and hospices can apply for a CAHPS exemption if they serve fewer 
than 50 survey--eligible decedents/caregivers in a given calendar year. 
The CAHPS Hospice measures are publicly available from the Provider 
CAHPS Hospice Survey Data file on the Hospice PDC. Additional details 
are in the QM User's Manual on the HQRP Current Measures web page. 
These CAHPS Hospice Survey measure scores are also publicly reported on 
the Care Compare website at https://www.medicare.gov/care-compare/?providerType=Hospice. As discussed in the SFP TEP report, TEP and 
other stakeholders agreed that the algorithm is strengthened by 
including the four CAHPS Hospice Survey measures as they reflect 
caregiver-reported experiences in key areas of hospice quality not 
reflected in claims or inspection surveys.
    From the CAHPS Hospice Survey data, we propose to use adjusted 
bottom-box scores of the four measures described previously above to 
create a CAHPS Hospice Survey Index. As described in the CMS document, 
``Calculating CAHPS[supreg] Hospice Survey Top-, Middle-, and Bottom-
Box Scores,'' that summarizes the steps we use to calculate CAHPS 
Hospice Survey measure scores, ``bottom-box'' scores are calculated for 
each respondent as ``100'' if the respondent selected the least 
positive response categories for that question and ``0'' if the 
respondent selected a different response category; survey respondents 
who do not answer a question are not included in the scoring of that 
question. In the CAHPS Hospice Survey, different questions have 
different response scales, so the bottom-box responses vary across the 
survey. For example, for questions with response options of ``Yes, 
definitely,'' ``Yes, somewhat,'' and ``No,'' the bottom-box response is 
``No''; for questions with response options of ``Never,'' 
``Sometimes,'' ``Usually,'' and ``Always,'' the bottom-box responses 
are both ``Never'' and ``Sometimes''; Person-level bottom-box scores 
for each question are then adjusted for mode of survey administration 
and case-mix to produce hospice-level bottom-box scores. Bottom-box 
scores for a particular question can be interpreted as the percentage 
of respondents who selected the least positive response category(ies) 
after adjusting for mode of survey administration and differences in 
the mix of decedent/caregiver characteristics across hospices. 
Composite measure scores, such as those for Help for Pain and Symptoms 
and Getting Timely Help, are formed by taking the average of fully-
adjusted hospice-level question scores within the composite. We propose 
using bottom-box scores for the SFP, because they quantify reported 
problematic care experiences. To create the CAHPS Hospice Survey Index, 
we propose to calculate a single score for each hospice by taking a 
weighted sum of the bottom-box scores for the four CAHPS measures, as 
described later in this section. Specifically, we propose that the two 
measures that represent overall assessments of hospice care (that is, 
Willingness to Recommend this Hospice and Overall Rating of this 
Hospice) each be given a weight of 0.5 as these measures assess similar 
concepts. We propose to weight the other two measures, Help for Pain 
and Symptoms and Getting Timely Help, at 1.0 each to reflect that these 
measures assess distinct aspects of care.
    To illustrate, not including usually applied adjustments to the 
data for case mix and mode of survey administration, if Hospice A 
received a bottom-box score of 100 on the Overall Rating of this 
Hospice, that means that all the survey respondents responded to the 
question and gave the hospice an overall rating of zero to six, the 
least positive possible responses (middle-box options: 7-8; top-box 
option: 9-10). The hospice could then receive, a bottom-box score of 0 
on the Help for Pain and Symptoms measure, meaning none of the survey 
respondents selected the least positive responses on any of the 
questions that make up this measure. If Hospice A also received a 
bottom-box score of 12 on the Willingness to Recommend this Hospice and 
a bottom-box score of 4.5 on the Getting Timely Help measure, meaning 
that approximately 12 percent and 4.5 percent of respondents, 
respectively, selected the bottom-box scores, then Hospice A's total 
CAHPS Hospice Survey Index would be 60.5, calculated as follows: ((100 
+ 12) * 0.5) + (0 + 4.5) = 60.5. The maximum value for the CAHPS 
Hospice Survey Index would be 300 points. For this index, a lower 
number of points would indicate a higher quality score.
    Our analysis of CYs 2019 to 2021 (excluding January through June 
2020) CAHPS Hospice Survey data found that 49.3 percent of eligible 
hospice programs (2,929 of the 5,943 SFP-eligible hospices) report the 
four CAHPS Hospice Survey measures. Compared to the other three 
indicators (quality-of-care CLDs, substantiated complaints, and HCI), 
the scores from the four CAHPS measures are more dispersed around their 
average value. The average CAHPS Hospice Survey Index value for these 
four measures combined is 24, with an overall range of 2 to 83 from the 
SFP-eligible hospices (lower scores indicate better performance; total 
possible range: 0-300). The distribution of these values is roughly 
symmetric and centered on an average such that the likelihood of 
observing a value different from the average value becomes smaller the 
further away the value is from the average.
c. Proposed Data Source Preparation
    We propose to compile the data for the algorithm indicators 
(quality-of-care CLDs, substantiated complaints, HCI, the four CAHPS 
Hospice measures) and remove hospices not eligible for SFP to create a 
single score for every hospice. A Medicare-certified hospice program 
would be included in the algorithm if it--(1) is an active provider 
that has billed at least one claim to Medicare FFS in the last 12 
months as captured in iQIES; and (2) has data for at least one 
algorithm indicator.
    For the HCI and CAHPS data, we propose pulling the latest HCI and 
CAHPS data from the Hospice PDC. For example, we would use data from 
November 2023 to identify the pool of hospices eligible to be in the 
SFP on or after January 1, 2024.
(1) Survey Data and HCI
    For the survey data, we propose the following steps to prepare data 
for the algorithm:
     Step One: We propose to pull 3 consecutive years of survey 
data preceding the release of the SFP selection list, including data 
for all relevant hospice survey types (initial certification, standard, 
complaint, and follow-up surveys). For identifying the pool of hospices 
eligible to be in the SFP on or after January 1, 2024, we propose to 
use 2020-2023 survey data.
     Step Two: From the survey data in Step One, we propose to 
count the total number of quality-of-care CLDs for each hospice in the 
data file. Quality-of-care CLDs can be found in any hospice survey 
(initial certification, standard, complaint, follow-up). They are 
denoted within a survey under specific citation codes (Table F2).
     Step Three: From the data file in Step One, we propose to 
count the total

[[Page 43762]]

number of substantiated complaints for each hospice in the data file. 
Substantiated complaints can be found in complaint and follow-up 
hospice surveys.
    Our initial analysis found that the proposed SFP-eligible hospices 
may have missing indicators from the survey data (quality-of-care CLDs, 
substantiated complaints,) and/or HCI. To address the algorithm's 
missing data for these indicators, we propose standardizing each 
indicator for quality-of-care CLDs, substantiated complaints, and HCI. 
Specifically, we propose that hospices missing any of these three 
indicators would be assigned a value of zero for that indicator after 
standardization (see section VI.B.4.d. of this proposed rule).
(2) CAHPS[supreg] Hospice Survey Data
    As discussed previously, CAHPS Hospice Survey data are not 
available for hospices that are exempt from participating due to size 
or newness, or for hospices for which there are fewer than 30 completed 
surveys over an eight-quarter reporting period. Since these hospices 
may differ systematically from hospices that do have publicly reported 
CAHPS Hospice Survey data, we do not believe it is appropriate to 
assign hospices the average value of the CAHPS Hospice Survey Index if 
they are missing these data. After standardizing the CAHPS Hospice 
Survey measures (using the same process for survey data and HCI as 
proposed in sections VI.B.4. and VI.B.4.d. of this proposed rule), we 
propose addressing missing CAHPS Hospice Survey data by averaging the 
total number of data indicators used to derive the score. The score for 
hospices with missing CAHPS Hospice Survey data would be based solely 
on all other indicators (CLDs, complaints, and HCI), and the score for 
hospices with available CAHPS Hospice Survey data includes the CAHPS 
Hospice Survey Index in addition to the other indicators (see section 
VI.B.4.d.(2) of this proposed ruled.
d. Proposed Data Source Standardization
    We propose standardizing each indicator (that is, quality-of-care 
CLDs, substantiated complaints, HCI, and the CAHPS Hospice Survey 
Index) to compare indicators equally despite each data source's 
different units of measurement. For example, both quality-of-care CLDs 
and substantiated complaints are continuous variables that have no 
ceiling to how many quality-of-care CLDs or substantiated complaints a 
single hospice can receive. In contrast, a hospice can only receive a 
maximum value of 10 from the HCI quality measure. Therefore, if we do 
not rescale HCI, we would be deemphasizing the importance of HCI for 
the SFP as a relevant dimension of care quality because the range of 
possible values for HCI is much smaller than the range of possible 
values for quality-of-care CLDs and substantiated complaints. By 
standardizing the data as proposed, we can understand how different the 
indicator is for a single hospice compared to the indicator from the 
average hospice and shift the unit to a magnitude of difference from 
the average across all indicators to compare the data source indicators 
under a shared measurement unit.
    As a simplified example to illustrate the importance of 
standardization, Hospice A has one quality-of-care CLD and HCI score of 
3. These two numbers' absolute differences are two (3 HCI-1 quality-of-
care CLD = 2). However, examining the absolute difference in these 
numbers does not indicate that Hospice A delivers poor care quality. To 
better explain how these two indicators relate to one another and 
quality, we look at the likelihood that Hospice A would receive one 
quality-of-care CLD and the likelihood that it would receive an HCI 
score of 3. To determine this likelihood, we propose comparing these 
numbers to the respective averages of all other hospices for the 
indicators. The average number of quality-of-care CLDs for hospices is 
a little less than 0.5. Most hospices have zero quality-of-care CLDs. 
While a quality-of-care CLD of one is larger than the average (0.5), 
the magnitude of difference between the one quality-of-care CLD in 
Hospice A and the 0.5 quality-of-care CLDs for the average hospice is 
not very large. When considering HCI, the average HCI score for all 
hospices is 8.9 (a higher HCI score indicates better performance on the 
measure). An HCI score of three is a large difference from the average 
of 8.9, and as a result, it is unlikely that a hospice would receive 
this kind of score if it was an average HCI performer. The likelihood 
of observing a value different from the average is the type of 
information we propose to include to determine poor performers. By 
standardizing the indicators, we shift our interpretation from what 
value they received to an estimation of how likely they are to receive 
the value if they were an average hospice. We believe this approach 
would improve the proposed algorithm's ability to identify those 
hospice programs with the most unlikely values across our four 
indicators and those that are the poorest performers across indicators 
compared to all other active hospices in the SFP analytic file.
    The previous fictitious example illustrates how indicators are 
standardized. We propose to adopt the most common standardization 
method, which would be applied to each of the indicators for a specific 
hospice (hospice indicators). For each indicator, this would be done by 
taking the indicator's observed value for the hospice and subtracting 
that indicator's average value for all hospices. We propose to then 
divide this number (the difference) by the standard deviation, a common 
measure of data variance, to tell us how clustered data are around the 
average (see the following equation).
[GRAPHIC] [TIFF OMITTED] TP10JY23.076

    As a function of this proposed approach, all indicators are 
centered with a mean of zero and a standard deviation of one. The 
transformed indicator tells us how likely a value for a given hospice 
would be observed and allows us to compare indicators (by adding them 
together) to determine which hospices have the most unlikely values 
compared to other hospices.
(1) Proposed Weighting of the Standardized Values
    The proposed standardization discussed earlier allows an 
indicator's data to be compared to another standardized indicator. 
Therefore, we would be comparing how different the observed value is 
from the average value to make all indicators mathematically equal. We 
propose to weight each indicator by multiplying an indicator by a 
constant value to account for their relative importance in the 
methodology.
    As part of our consideration for determining the weights for each 
indicator, the TEP and stakeholder listening sessions offered 
considerations related to weighting the data sources. In discussing the 
weighting of

[[Page 43763]]

substantiated complaints, quality-of-care CLDs, and HCI, the TEP and 
stakeholders agreed that they represent relevant dimensions of care 
quality but did not raise concerns or discuss whether one of these 
indicators was more or less indicative of care quality relative to 
another. However, the TEP and stakeholders emphasized the importance of 
patient and caregiver perspectives represented by the CAHPS measures, 
noting they are the most integral dimension of hospice care quality. As 
discussed in the SFP TEP report on page 15, ``some TEP members argued 
that the valuable perspectives of families and caregivers on the CAHPS 
Hospice Survey justified weighting it more than other data sources.'' 
Based on the consistent feedback from the TEP and stakeholder listening 
sessions, we propose to weight the CAHPS Hospice Survey Index by twice 
that of the other measures (that is, multiply CAHPS Hospice Survey 
Index by two).
(2) Proposed Approach for Missing CAHPS Data
    In three of the four indicators used in the algorithm, data exhibit 
an exceptional amount of concentration around the average value for the 
indicator. We propose replacing missing values in quality-of-care CLDs, 
substantiated complaints, and HCI with the average value for each of 
those indicators for an individual hospice to assign a score to that 
hospice (see section VI.B.4.d. of this proposed rule).
    The CAHPS Hospice Survey, Index is distinct from these other three 
indicators for several reasons warranting separate treatment for its 
missingness. First, the CAHPS Hospice Survey Index does not exhibit the 
same high concentration around the average value as the other measures. 
This means that there is more variability in the CAHPS Hospice Survey 
Index than in the other indicators. As a result of this increased 
variability, it is increasingly unlikely that those values that are 
missing are close to the average value. Second, more hospices are 
missing CAHPS Hospice Survey data than are missing data for other 
indicators in the algorithm. In our review of the CY 2019-2021 analytic 
file (excluding January 1-June 30, 2020), there is CAHPS Hospice Survey 
data for only about 49 percent of all SFP-eligible hospices. Due to 
reporting exemptions for small and/or newer hospices, those missing 
values are disproportionately from that cohort of providers. Because of 
this trend, it is difficult to draw any conclusions about the missing 
values given that there are no data from small hospices by which we can 
compare if the smaller/newer hospice CAHPS average is similar to those 
for which we have observed data. Third, hospices with fewer than 50 
distinct beneficiaries can file for an exemption from reporting CAHPS. 
If we replace missing CAHPS Hospice Survey measure values with the 
average value, poor performing small hospices could benefit from being 
small by opting into being treated as an average hospice by becoming 
exempt from reporting their poor CAHPS Hospice Survey measure values. 
For these reasons, we propose a different treatment for CAHPS Hospice 
Survey missingness. Instead of replacing missing CAHPS Hospice Survey 
measure scores with the average values for those measures, we propose 
to run hospices with data for CAHPS Hospice Survey measures through a 
version of the algorithm that considers the CAHPS Hospice Survey Index, 
and for those hospices that do not have CAHPS Hospice Survey data, 
through a version of the algorithm that does not consider the CAHPS 
Hospice Survey Index. To make the two resulting scores comparable, we 
then average the scores based on the total number of indicators used to 
calculate the score.
    For the hospices without CAHPS Hospice Survey data, we would divide 
their scores by three because their score was calculated from three 
indicators: quality-of-care CLDs, substantiated complaints, and HCI. 
For the hospices with CAHPS Hospice Survey data, we would divide their 
scores by five because the weight on the CAHPS Hospice Survey Index 
means it is mathematically counted twice, so the indicators would be 
quality-of-care CLDs, substantiated complaints, HCI, and the CAHPS 
Hospice Survey Index, which is counted twice due to the weight of two 
on the indicator. This approach to handling missing CAHPS data is 
beneficial because it does not make assumptions about the values for 
missing CAHPS data.
     With CAHPS Hospice Survey Index:
    [GRAPHIC] [TIFF OMITTED] TP10JY23.077
    
     Without CAHPS Hospice Survey Index:
    [GRAPHIC] [TIFF OMITTED] TP10JY23.078
    
(3) Example Results
    To illustrate how the proposed algorithm would behave, we discuss 
later in this section how two example hospices' (Hospice A's and 
Hospice B's) algorithm scores would be produced based on their 
indicator values. As discussed previously, the methodology would be one 
step in determining whether a hospice is selected for the SFP.
    Hospice A is a large hospice, serving 500 beneficiaries on average 
over the last 3 years. Over the past 3 years, they received zero 
quality-of-care CLDs, two substantiated complaints, and an HCI score of 
nine. At the same time, their CAHPS Hospice Survey Index measure is 
44.5, which is larger than the average value of 28, which may indicate 
a quality concern. When we standardize these values to examine how 
different they are from the average hospice, we find that their 
quality-of-care CLD standardized value is zero, their substantiated 
complaint standardized value is 0.6, their HCI is 0.1, and their CAHPS 
Hospice Survey Index is 2.4. As we suspected, three of their indicators 
are closely in line with the average hospice. Only their CAHPS Hospice 
Survey Index of 2.4 tells us that their bottom-box scores for the four 
quality measures is 2.4 standard deviations away from the average 
hospice. We would then include these four indicators in the algorithm: 
0 + 0.6-0.1 + (2*2.4) = 5.3. As explained above, for hospices with 
CAHPS data, we would

[[Page 43764]]

divide their scores by five, and since Hospice A has a CAHPS Hospice 
Survey Index, the final value would be divided by five. Hospital A's 
final algorithm score is: 5.3/5 = 1.06. We then take this score and 
compare it to all other scores generated from all hospices and put them 
in order from highest to lowest, and we find that Hospice A ranks at 
331. Because of the algorithm's emphasis on CAHPS, Hospice A's poor 
CAHPS Hospice Survey Index would make it more likely to be identified 
as a candidate, but because Hospice A performed well on the other three 
indicators, it would be less likely to be selected as a SFP participant 
compared to other hospices.
    Hospice B is a mid-sized hospice serving an average of 120 distinct 
beneficiaries over the past 3 years. It has not reported CAHPS Hospice 
Survey data across the four measures. They received 42 substantiated 
complaints, 15 quality-of-care CLDs, and an HCI of 10. The number of 
substantiated complaints and quality-of-care CLDs are quite high even 
though they have achieved all 10 indicators of HCI. After we 
standardize, Hospice B's quality-of-care CLD value is 9.2, its 
complaint rate is 16.4, and its HCI is 0.9. We would calculate Hospice 
B's score in the following way: 9.2 + 16.4-0.9 = 24.7. As explained 
previously, for hospices without CAHPS[supreg] data, we would divide 
their scores by three, and since Hospice B does not have a CAHPS 
Hospice Survey Index, this final value would be divided by three: 24.7/
3 = 8.2. When comparing this score of 8.2 to all other hospices, we 
would find that Hospice B has the highest algorithm score among all 
hospices, indicating it has the poorest quality indicator outcomes. 
Even though its HCI score is high and we do not know its CAHPS value, 
Hospice B's high substantiated complaint rate and high number of 
quality-of-care CLDs would make it a very likely candidate for the SFP.
e. Proposed Selection Criteria
    Based on public comment in the CY 2022 HH PPS final rule and 
recommendations from the SFP TEP and other stakeholders, we propose a 
SFP selection process that utilizes a no-stratification approach. In 
addition, we considered the input of the SFP TEP and stakeholders, who 
expressed that the selection approach should identify the poorest 
performing hospices, regardless of characteristics, such as size or 
location, and therefore favored an approach with no stratification by 
state or otherwise.
    We propose at Sec.  488.1135(b) that hospices with AO deemed status 
that are placed in the SFP would not retain deemed status and would be 
placed under CMS or, as needed, SA oversight jurisdiction until 
completion of the SFP or termination.
    The number of hospices selected to participate in the SFP would be 
determined in the first quarter of each calendar year. The claims-based 
quality measure data used in the proposed algorithm is not available 
until November of each calendar year. This data is needed to run the 
algorithm, which is used to establish the aggregate score from which 
SFP participants are selected. As an SFP selectee, a hospice would not 
be removed from the SFP until they either meet the criteria for 
graduation or are terminated from the Medicare program.
f. Proposed Survey and Enforcement Criteria
    As indicated in the CAA, 2021 adding section 1822(b)(2) of the Act, 
once in the SFP, a hospice must be surveyed ``not less than once every 
6 months.'' Based on the TEP discussion, TEP members agreed with the 6-
month recertification survey frequency for hospices in the SFP, and we 
are proposing this frequency at proposed Sec.  488.1135(c). 
Additionally, SFP hospices would be subject to one or more remedies 
specified in Sec.  488.1220, and progressive enforcement remedies, as 
appropriate, at the discretion of CMS and consistent with 42 CFR part 
488, subpart N. When CMS chooses to apply one or more remedies 
specified in Sec.  488.1220, the remedies would be applied on the basis 
of noncompliance with one or more conditions of participation and may 
be based on failure to correct previous deficiency findings as 
evidenced by repeat condition-level deficiencies. The enforcement 
remedies could be imposed for an SFP hospice with condition-level 
deficiencies on a SFP survey or complaint survey while in the program. 
Furthermore, if subsequent surveys also result in the citation of a 
condition-level deficiency or deficiencies for an SFP hospice, the 
enforcement remedies imposed could be of increasing severity. 
Increasing severity could mean a higher CMP than was imposed for the 
earlier noncompliance or increasing from one remedy to more than one 
remedy being imposed. CMS would use its discretion to determine what 
remedies are most appropriate given the survey results, and the hospice 
may be subject to remedies of increasing severity.
g. Proposed SFP Completion Criteria
    The TEP generally agreed that to complete and graduate from the 
SFP, SFP hospices should have no CLDs cited for two consecutive 6-month 
recertification surveys in an 18-month timeframe. TEP members also 
suggested that SFP hospices should have no substantiated complaints and 
less than a defined number of standard-level deficiencies (SLDs) on two 
consecutive 6-month recertification surveys within the 18-month 
timeframe to complete the SFP. TEP members recommended a stepwise 
completion process, with SFP hospices preliminarily graduating after 
completing two consecutive 6-month recertification surveys within the 
18-month timeframe in accordance with all completion requirements as 
proposed at Sec.  488.1135(d). We considered the TEP's recommendations. 
However, we are proposing that SFP hospices have no CLDs for any two 
SFP surveys in an 18-month period. Therefore, we propose in new Sec.  
488.1135(d) that a hospice will have completed the SFP if it has in an 
18-month timeframe, no CLDs cited or IJ's for any two 6-month SFP 
surveys, and has no pending complaint survey triaged at an immediate 
jeopardy or condition level, or has returned to substantial compliance 
with all requirements. If there are complaint investigations or a 36-
month recertification survey for a hospice while in the SFP, the SFP 
timeline may extend beyond the 18-month timeframe. The official 
completion date would be the date of the CMS notice letter informing 
the hospice of its removal from the SFP. After completing the SFP, 
hospice programs would receive a one-year post SFP survey and then 
would start a new standard 36-month survey cycle.
h. Proposed Termination Criteria
    A hospice in the SFP that fails any two SFP surveys, by having any 
CLDs on the surveys, in an 18-month period, or pending complaint 
investigations triaged at IJ or condition-level, would be considered 
for termination from the Medicare program as proposed at new Sec.  
488.1135(e). This criterion would apply to all hospices, regardless of 
geographical location, and reflects some TEP recommendations. CMS would 
issue the termination letter to the hospice program in accordance with 
42 CFR 489.53. Depending on the deficiencies that brought a hospice 
into the SFP, CMS recognizes that a provider may need a reasonable 
period to achieve substantial compliance. But, if the hospice is not 
able to achieve substantial compliance at any time during the 18 
months, they would be considered for termination from the Medicare 
program. Those providers that are unable to resolve the deficiencies 
that brought them into the SFP and

[[Page 43765]]

cannot meet the proposed completion criteria of having no CLDs cited 
for any two SFP surveys during an 18-month period, would be placed on a 
termination track. If a hospice in the SFP has an IJ-level deficiency 
cited during a survey, CMS would follow the requirements at Sec.  
488.1225.
i. Public Reporting of SFP Information
    Public reporting of the proposed SFP includes making accessible 
both general information about the SFP program and hospices selected 
for SFP. A guideline for communicating SFP information appears in the 
section 407 of CAA, 2021 (Pub. L. 116-260), which requires hospice 
survey findings to be ``prominent, easily accessible, readily 
understandable, and searchable for the general public and allows for 
timely updates.''
    We propose in new Sec.  488.1135(f) to publicly report, at least on 
an annual basis, the hospice programs selected for the SFP under 
proposed Sec.  488.1135(b). Initially, this information would be posted 
on a CMS public-facing website at https://www.cms.gov/medicare/quality-safety-oversight-certification-compliance/hospice-special-focus-program, or a successor website. Specifically, we propose the website 
will include, at a minimum, general information, program guidance, a 
subset consisting of 10 percent of hospice programs based on the 
highest aggregate scores determined by the algorithm, and SFP 
selections from the 10 percent subset as determined by CMS, and SFP 
status as proposed in the definitions at Sec.  488.1105.

VII. Proposed Changes Regarding Durable Medical Equipment, Prosthetics, 
Orthotics, and Supplies (DMEPOS)

A. Medicare Durable Medical Equipment, Prosthetics, Orthotics, and 
Supplies (DMEPOS) Competitive Bidding Program (CBP)

1. Background
a. Durable Medical Equipment, Prosthetics, Orthotics, and Supplies 
Competitive Bidding Program
    Section 1847(a) of the Act, as amended by section 302(b)(1) of the 
Medicare Prescription Drug, Improvement, and Modernization Act of 2003 
(Pub. L. 108-173, December 8, 2003), mandates the Medicare Durable 
Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) 
Competitive Bidding Program (CBP) for contract award purposes to 
furnish certain competitively priced DMEPOS items and services subject 
to the CBP--
     Off-the-shelf (OTS) orthotics, for which payment would 
otherwise be made under section 1834(h) of the Act;
     Enteral nutrients, equipment, and supplies described in 
section 1842(s)(2)(D) of the Act; and
     Certain DME and medical supplies, which are covered items 
(as defined in section 1834(a)(13) of the Act) for which payment would 
otherwise be made under section 1834(a) of the Act.
    For a list of product categories included in the DMEPOS CBP, please 
refer to https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/DMEPOSCompetitiveBid/Round-2021/PCs. Areas in which the CBP are not 
implemented are known as non-competitive bidding areas (non-CBAs). We 
use the term ``former CBAs'' to refer to the areas that were formerly 
CBAs prior to a gap in the CBP, to distinguish those areas from ``non-
CBAs.'' More information on why there was a gap in the CBP from January 
1, 2019, through December 31, 2020, can be found in the November 14, 
2018 final rule titled ``Medicare Program; End-Stage Renal Disease 
Prospective Payment System, Payment for Renal Dialysis Services 
Furnished to Individuals With Acute Kidney Injury, End-Stage Renal 
Disease Quality Incentive Program, Durable Medical Equipment, 
Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding 
Program (CBP) and Fee Schedule Amounts, and Technical Amendments To 
Correct Existing Regulations Related to the CBP for Certain DMEPOS,'' 
(83 FR 56922).
b. Fee Schedule Adjustment Methodology for Non-CBAs
    Section 1834(a)(1)(F)(ii) of the Act requires the Secretary to use 
information on the payment determined under the Medicare DMEPOS CBP to 
adjust the fee schedule amounts for DME items and services furnished in 
all non-CBAs on or after January 1, 2016. Section 1834(a)(1)(F)(iii) of 
the Act requires the Secretary to continue to make these adjustments as 
additional covered items are phased in under the CBP or information is 
updated as new CBP contracts are awarded. Similarly, sections 
1842(s)(3)(B) and 1834(h)(1)(H)(ii) of the Act authorize the Secretary 
to use payment information from the DMEPOS CBP to adjust the fee 
schedule amounts for enteral nutrition and OTS orthotics, respectively, 
furnished in all non-CBAs. Section 1834(a)(1)(G) of the Act requires 
the Secretary to specify the methodology to be used in making these fee 
schedule adjustments by regulation, and to consider, among other 
factors, the costs of items and services in non-CBAs (where the 
adjustments would be applied) compared to the single payment amounts 
for such items and services in the CBAs.
    The methodologies set forth in Sec.  414.210(g) account for 
regional variations in prices, including for rural and non-contiguous 
areas of the United States. In accordance with Sec.  414.210(g)(1), 
regional adjustments to fee schedule amounts for each state in the 
contiguous United States and the District of Columbia, are determined 
based on the definition of region in Sec.  414.202, which refers to 
geographic areas defined by the Bureau of Economic Analysis (BEA) in 
the Department of Commerce for economic analysis purposes (79 FR 
66226). Under Sec.  414.210(g)(1)(i) through (iv), adjusted fee 
schedule amounts for areas within the contiguous United States are 
determined based on regional prices limited by a national ceiling of 
110 percent of the regional average price and a floor of 90 percent of 
the regional average price (79 FR 66225). Under Sec.  414.210(g)(1)(v), 
adjusted fee schedule amounts for rural areas are based on 110 percent 
of the national average of regional prices. Under Sec.  414.210(g)(2), 
fee schedule amounts for non-contiguous areas are adjusted based on the 
higher of the average of the single payment amounts for CBAs in non-
contiguous areas in the United States, or the national ceiling amount.
    Under existing rules, ZIP codes for rural, non-rural, and non-
contiguous areas are used to establish geographic areas that are then 
used to define non-CBAs for the purposes of the DMEPOS fee schedule 
adjustments. A rural area is defined in Sec.  414.202 as a geographic 
area represented by a postal ZIP code, if at least 50 percent of the 
total geographic area of the area included in the ZIP code is estimated 
to be outside any Metropolitan Statistical Area (79 FR 66228). A rural 
area also includes a geographic area represented by a postal ZIP code 
that is a low population density area excluded from a CBA in accordance 
with section 1847(a)(3)(A) of the Act at the time the rules in Sec.  
414.210(g) are applied. Non-contiguous areas refer to areas outside the 
contiguous United States--that is, areas such as Alaska, Guam, and 
Hawaii (81 FR 77936).

[[Page 43766]]

    Section 3712 of the of the CARES Act (Pub. L. 116-136, as enacted 
on March 27, 2020) revised the fee schedule amounts for certain DME and 
enteral nutrients, supplies, and equipment furnished in non-CBAs 
through the duration of the emergency period described in section 
1135(g)(1)(B) of the Act. Specifically, this emergency period is the 
Public Health Emergency (PHE) for COVID-19, including renewals of the 
PHE.
    Section 3712(a) of the CARES Act directed the Secretary to 
implement Sec.  414.210(g)(9)(iii) (or any successor regulation), to 
apply the transition rule described in such section to all applicable 
items and services as planned through December 31, 2020, and through 
the duration of the emergency period described in section 1135(g)(1)(B) 
of the Act, if longer. Therefore, section 3712(a) of the CARES Act 
continued our policy at Sec.  414.210(g)(9)(iii) of paying for DMEPOS 
items and services furnished in rural and non-contiguous non-CBAs based 
on a 50/50 blend of adjusted and unadjusted fee schedule amounts 
through December 31, 2020, or through the duration of the emergency 
period, whichever is longer. This fee schedule adjustment in rural and 
non-contiguous areas results in fee schedule amounts that are 
approximately 66 percent higher than the fully adjusted fee schedule 
amounts previously paid for DMEPOS items and services furnished in non-
rural areas in the contiguous United States.
    Section 3712(b) of the CARES Act directed the Secretary to increase 
the fee schedule amounts for DMEPOS items and services furnished in 
non-CBAs other than rural and non-contiguous non-CBAs through the 
duration of the COVID-19 PHE (the emergency period described in section 
1135(g)(1)(B) of the Act). Beginning March 6, 2020, the payment rates 
for DME and enteral nutrients, supplies, and equipment furnished in 
these areas was based on 75 percent of the adjusted fee schedule amount 
and 25 percent of the historic, unadjusted fee schedule amount until 
the end of the emergency period, which results in higher payment rates 
as compared to the fully adjusted fee schedule amounts under Sec.  
414.210(g)(9)(iv). This increased payments so that they are 
approximately 33 percent higher than the payments at the fully adjusted 
fee schedule amounts.
    In the May 8, 2020, interim final rule with comment period (IFC) 
(85 FR 27550) titled ``Medicare and Medicaid Programs, Basic Health 
Program, and Exchanges; Additional Policy and Regulatory Revisions in 
Response to the COVID-19 Public Health Emergency and Delay of Certain 
Reporting Requirements for the Skilled Nursing Facility Quality 
Reporting Program'' (hereinafter referred to as the ``May 2020 COVID-19 
IFC''), conforming changes were made to Sec.  414.210(g)(9), consistent 
with section 3712(a) and (b) of the CARES Act.
    The final rule entitled, ``Medicare Program; Durable Medical 
Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Policy Issues, 
and Level II of the Healthcare Common Procedure Coding System (HCPCS); 
DME Interim Pricing in the CARES Act; Durable Medical Equipment Fee 
Schedule Adjustments To Resume the Transitional 50/50 Blended Rates To 
Provide Relief in Rural Areas and Non-Contiguous Areas'' published in 
the December 28, 2021 Federal Register (86 FR 73860) (hereinafter CY 
2022 DMEPOS final rule), established fee schedule adjustment 
methodologies for items and services furnished in non-CBAs on or after 
February 28, 2022, or the date immediately following the duration of 
the emergency period described in section 1135(g)(1)(B) of the Act (42 
U.S.C. 1320b-5(g)(1)(B)), whichever is later.
    The CY 2022 DMEPOS final rule explained that the 50/50 blended 
rates in non-contiguous non-CBAs will continue to be paid, but the 50/
50 blend would no longer be a transition rule under Sec.  414.210(g)(9) 
and would instead be the fee schedule adjustment methodology for items 
and services furnished in these areas under Sec.  414.210(g)(2) unless 
revised in future rulemaking. For items and services furnished in non-
contiguous non-CBAs, the fee schedule amounts for such items and 
services furnished on or after the effective date of the CY 2022 DMEPOS 
final rule (February 28, 2022), or the date immediately following the 
duration of the emergency period described in section 1135(g)(1)(B) of 
the Act, whichever is later, would be adjusted so that they are equal 
to a blend of 50 percent of the greater of the average of the SPAs for 
the item or service for CBAs located in non-contiguous areas or 110 
percent of the national average price for the item or service 
determined under Sec.  414.210(g)(1)(ii) and 50 percent of the 
unadjusted fee schedule amount for the area, which is the fee schedule 
amount in effect on December 31, 2015, increased for each subsequent 
year beginning in 2016 by the annual update factors specified in 
sections 1834(a)(14), 1834(h)(4), and 1842(s)(1)(B) of the Act, 
respectively, for durable medical equipment and supplies, off-the-shelf 
orthotics, and enteral nutrients, supplies, and equipment (86 FR 
73873).
    As explained in the CY 2022 DMEPOS final rule, the 50/50 blended 
rates in rural contiguous areas will continue to be paid, but the 50/50 
blend would no longer be a transition rule under Sec.  414.210(g)(9) 
and would instead be the fee schedule adjustment methodology for items 
and services furnished in these areas under Sec.  414.210(g)(2) unless 
revised in future rulemaking. For items and services furnished in rural 
contiguous areas on or after February 28, 2022, or the date immediately 
following the duration of the emergency period described in section 
1135(g)(1)(B) of the Act, whichever is later, the fee schedule amounts 
would be adjusted so that they are equal to a blend of 50 percent of 
110 percent of the national average price for the item or service 
determined under Sec.  414.210(g)(1)(ii) and 50 percent of the fee 
schedule amount for the area in effect on December 31, 2015, increased 
for each subsequent year beginning in 2016 by the annual update factors 
specified in sections 1834(a)(14), 1834(h)(4), and 1842(s)(1)(B) of the 
Act, respectively, for DME and medical supplies, off-the-shelf 
orthotics, and enteral nutrients, supplies, and equipment (86 FR 
73873).
    Finally, for items and services furnished on or after February 28, 
2022, or the date immediately following the termination of the 
emergency period described in section 1135(g)(1)(B) of the Act (42 
U.S.C. 1320b-5(g)(1)(B)) (that is, the COVID-19 PHE), whichever is 
later, in all other non-rural, non-CBAs within the contiguous United 
States, the fee schedule amounts would be equal to 100 percent of the 
adjusted payment amount established under Sec.  414.210(g)(1)(iv).
2. Current Issues
    Section 4139 of Division FF, Title IV, Subtitle D of the CAA, 2023 
sets the fee schedule adjustment methodologies for non-competitive 
bidding areas through the remainder of the duration of the emergency 
period described in section 1135(g)(1)(B) of the Act or December 31, 
2023, whichever is later. The federal PHE for COVID-19, declared by the 
Secretary under Section 319 of the Public Health Service Act, expired 
at the end of the day on May 11, 2023. We are proposing to make 
conforming changes to the regulation at 42 CFR 414.210(g)(9) to account 
for these changes.
    Specifically, section 4139(a) of the CAA, 2023 directs the 
Secretary to implement 42 CFR 414.210(g)(9)(v) (or any successor 
regulation), to apply the

[[Page 43767]]

transition rule described in the first sentence of such section to all 
applicable items and services furnished in areas other than rural or 
noncontiguous areas through the remainder of the duration of the 
emergency period described in section 1135(g)(1)(B) of the Act (42 
U.S.C. 1320b-5(g)(1)(B)) or December 31, 2023, whichever is later. This 
continues the policy set forth by section 3712(b) of the CARES Act, 
which requires CMS to pay for these DMEPOS items and services furnished 
in areas other than rural or noncontiguous areas based on 75 percent of 
the adjusted fee schedule amount and 25 percent of the historic, 
unadjusted fee schedule amount until the end of the emergency period. 
This increases payments so that they are approximately 33 percent 
higher than the payments at the fully adjusted fee schedule amounts.
    Section 4139(b) of the CAA, 2023 directs the Secretary to not 
implement 42 CFR 414.210(g)(9)(vi) of title 42, Code of Federal 
Regulations (or any successor regulation) until the date immediately 
following the last day of the emergency period described in section 
1135(g)(1)(B) of the Act (42 U.S.C. 1320b-5(g)(1)(B)), or January 1, 
2024, whichever is later. This change has the effect of continuing the 
policy at Sec.  414.210(g)(9)(vi), but changes the February 28, 2022 
date in the regulation to January 1, 2024. That is, the fee schedule 
amount for all non-CBAs is equal to the adjusted payment amount 
established under paragraph (g) of this section only until the date 
immediately following the last day of the emergency period described in 
section 1135(g)(1)(B) of the Act (42 U.S.C. 1320b-5(g)(1)(B)), or 
January 1, 2024, whichever is later.
    Additionally, section 4139 of the CAA, 2023 does not affect the 
current adjusted fee schedule amounts in former CBAs. In accordance 
with Sec.  414.210(g)(10), the fee schedule amounts in the former CBAs 
will continue to be based on the single payment amounts from 2018 
increased by update factors for subsequent calendar years until new 
competitive bidding contracts are in place.
3. Proposed Changes
    We are proposing to make conforming changes to Sec.  414.210(g)(9), 
consistent with requirements in section 4139(a) and 4139(b) of the CAA, 
2023. First, section 4139 of the CAA, 2023 does not change the current 
policy under Sec.  414.210(g)(9)(iii) of paying for DMEPOS items and 
services furnished in rural and non-contiguous non-CBAs based on a 50/
50 blend of adjusted and unadjusted fee schedule amounts through the 
duration of the PHE for COVID-19. While section 4139 of the CAA, 2023 
does not specifically mention Sec.  414.210(g)(9)(iii), we believe that 
section 4139(b) of the CAA, 2023 prohibits implementation of the 
regulation language in Sec.  414.210(g)(vi) until the date immediately 
following the last day of the PHE, or January 1, 2024. This regulation 
applies the transition rules for the adjusted payment amount in the 
non-CBAs established under paragraph (g) of Sec.  414.210 to items and 
services furnished in ``all areas,'' and it also provides for extension 
of the transition 50/50 blended rates in rural, non-contiguous areas 
and non-rural areas through December 31, 2023, if the PHE ends prior to 
that date. We are proposing to revise Sec.  414.210(g)(9)(vi), as 
described in this rule. Further, we are proposing to revise Sec.  
414.210(g)(9)(iii), to state that for items and services furnished in 
rural areas and non-contiguous areas (Alaska, Hawaii, and U.S. 
territories) with dates of service from June 1, 2018 through the 
duration of the emergency period described in section 1135(g)(1)(B) of 
the Act (42 U.S.C. 1320b-5(g)(1)(B)) or December 31, 2023, whichever is 
later, based on the fee schedule amount for the area is equal to 50 
percent of the adjusted payment amount established under this section 
and 50 percent of the unadjusted fee schedule amount. We are proposing 
to make conforming changes to Sec.  414.210(g)(2) for the rural and 
non-contiguous areas in order to reference the December 31, 2023 date 
specified in section 4139 of the CAA, 2023.
    We are proposing to revise Sec.  414.210(g)(9)(v) to state that for 
items and services furnished in areas other than rural or noncontiguous 
areas with dates of service from March 6, 2020 through the remainder of 
the duration of the emergency period described in section 1135(g)(1)(B) 
of the Act (42 U.S.C. 1320b-5(g)(1)(B)) or December 31, 2023, whichever 
is later, the fee schedule amount for the area is equal to 75 percent 
of the adjusted payment amount established under this section and 25 
percent of the unadjusted fee schedule amount. We are proposing to 
remove outdated text from Sec.  414.210(g)(9)(v) that states ``for 
items and services furnished in areas other than rural or noncontiguous 
areas with dates of service from the expiration date of the emergency 
period described in section 1135(g)(1)(B) of the Act (42 U.S.C. 1320b-
5(g)(1)(B)), through December 31, 2020, the fee schedule amount for the 
area is equal to 100 percent of the adjusted payment amount established 
under this section.'' This is text was added in the May 2020 COVID-19 
IFC (85 FR 27571), as section 3712(b) of the CARES Act required CMS to 
pay the higher fee schedule amounts for the duration of the emergency 
period described in section 1135(g)(1)(B) of the Act (42 U.S.C. 1320b-
5(g)(1)(B)), but it did not specify the fee schedule amounts that 
should be in effect if the emergency period ends before December 31, 
2020. If not for section 3712(b) of the CARES Act, CMS would have paid 
the fully adjusted fee schedule amounts for DME items and services 
furnished in non-rural and contiguous non-CBAs until December 31, 2020. 
As such, Sec.  414.210(g)(9)(v) specified that the fee schedule amounts 
in non-rural and contiguous non-CBAs would again be based on 100 
percent of the fee schedule amounts adjusted in accordance with Sec.  
414.210(g)(1)(iv) if the emergency period described in section 
1135(g)(1)(B) of the Act (42 U.S.C. 1320b-5(g)(1)(B)) ended before 
December 31, 2020. As this situation no longer applies and is in the 
past, we are proposing to remove this obsolete text from Sec.  
414.210(g)(9)(v).
    We are proposing to revise Sec.  414.210(g)(9)(vi) to state that 
for items and services furnished in all areas with dates of service on 
or after the date immediately following the duration of the emergency 
period described in section 1135(g)(1)(B) of the Act, or January 1, 
2024, whichever is later, the fee schedule amount for the area is equal 
to the adjusted payment amount established under paragraph (g) of this 
section. Finally, we are proposing to make conforming changes to Sec.  
414.210(g)(2) for the rural and non-contiguous areas in order to 
specify the December 31, 2023 date specified in section 4139 of the 
CAA, 2023.
    Finally, section 4139(c) of the CAA, 2023 authorizes the Secretary 
to implement the provisions of this section by program instruction or 
otherwise. Given that the PHE for COVID-19 ended on May 11, 2023, which 
is prior to when the proposed changes to the regulations would be 
finalized, we intend to issue program instructions or other 
subregulatory guidance to effectuate the changes, as previously 
described. We believe this approach will serve to ensure a smooth 
transition after the end of the PHE for COVID-19.

B. Scope of the Benefit and Payment for Lymphedema Compression 
Treatment Items

1. Statutory Authority
    Effective for items furnished on or after January 1, 2024, section 
4133(a)(1)

[[Page 43768]]

of Division FF, Title V, Subtitle D of the CAA, 2023 amends section 
1861 of the Act, adding subparagraph (JJ) to subsection (s)(2) and 
coverage under a new benefit category under Medicare Part B for 
lymphedema compression treatment items as defined in new subsection 
(mmm) of section 1861 of the Act. Section 4133(a)(2) of the CAA, 2023 
amends section 1833(a)(1) of the Act, adding subparagraph (GG) to 
indicate that the amount paid for lymphedema compression treatment 
items defined in section 1861(mmm) of the Act shall be equal to 80 
percent of the lesser of the actual charge or the amount determined 
using the payment basis established by the Secretary under paragraph 
(1) of new subsection (z) of section 1834 of the Act. Paragraph (2) of 
new subsection (z) of section 1834 of the Act prohibits payments under 
Part B for lymphedema compression treatment items furnished other than 
at such frequency as the Secretary may establish. Paragraph (3) of new 
subsection (z) of section 1834 of the Act specifies that in the case of 
lymphedema compression treatment items that are included in a 
competitive bidding program under section 1847(a) of the Act, the 
payment basis under section 1847(a) of the Act shall be the payment 
basis determined under the competitive bidding program, and the 
Secretary may use information on the payment determined under the 
competitive bidding program to adjust the payment amount otherwise 
determined under section 1834(z) of the Act for an area that is not a 
competitive bidding area under section 1847 of the Act. Section 
4133(a)(3) of the CAA, 2023 amends section 1847(a)(2) of the Act, 
adding lymphedema compression treatment items to the competitive 
bidding program under subparagraph (D) of section 1847(a)(2) of the 
Act. Finally, section 4133(b)(3) of the CAA, 2023 amends section 1834 
of the Act under subsections (a)(20)(D) and (j)(5) to mandate 
application of the DMEPOS quality standards and accreditation and 
DMEPOS supplier enrollment and supplier standards requirements, 
respectively, to suppliers of lymphedema compression treatment items.
2. Background
    Currently, Medicare Part B does not include coverage for lymphedema 
compression treatment items other than compression pumps and 
accessories that meet the definition of DME covered under the DME 
benefit category under section 1861(n) of the Act. Section 4133 of the 
CAA, 2023 amends the Act to establish a new Part B benefit category for 
lymphedema compression treatment items.
    The lymphatic system is an integral component of the human 
circulatory system and consists of lymphatic vessels, lymph nodes and 
associated lymphoid organs.146 147 The International Society 
of Lymphology defines lymphedema as ``an external (and/or internal) 
manifestation of lymphatic system insufficiency and deranged lymph 
transport'' and is ``a symptom or sign resulting from underlying 
lymphatic disease.\148\ '' The Centers for Disease Control and 
Prevention (CDC) defines lymphedema as swelling due to a buildup of 
lymph fluid in the body.\149\ According to the National Institutes of 
Health (NIH) National Library of Medicine, lymphedema is a chronic 
disorder characterized by swelling under the skin caused by the 
inability of protein rich lymph fluid to drain, usually due to a 
blockage or damage to the lymph system.\150\ Additionally, according to 
the National Lymphedema Network, this swelling commonly occurs in the 
arm or leg, but it may also occur in other body areas including the 
breast, chest, head and neck, and genitals.\151\ Lymphedema develops 
when a body region, where lymphatic vessels and lymph nodes are missing 
or impaired, becomes overloaded with lymphatic fluid. Lymphedema is a 
chronic condition with no definitive curative treatment that can become 
progressive, so early detection and institution of decompressive 
measures are essential in avoiding its potentially disabling 
sequela.152 153 154 155 The gradual accumulation of plasma 
and cellular components into the interstitial tissue space leads to a 
chronic inflammatory process that can result in long-term tissue 
changes and permanent structural damage to the affected anatomical site 
and its overlying skin layer.156 157 158 These changes also 
make the patient more susceptible to skin and potentially disabling or 
life-threatening soft tissue infections.159 160 The physical 
manifestations of lymphedema are tissue swelling, pain, heaviness and 
difficulty using the affected body part.\161\
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    \146\ Aspelund A, Robciuc MR, Karaman S, Makinen T, Alitalo K. 
Lymphatic System in Cardiovascular Medicine. Circulation Research. 
2016. Volume 118(3). 515-530.
    \147\ Suamia H, Scaglioni MF. Anatomy of the Lymphatic System 
and the Lymphosome Concept with Reference to Lymphedema. Seminars in 
Plastic Surgery. 2018 Feb; 32(1): 5-11.
    \148\ International Society of Lymphology Executive Committee. 
The Diagnosis and Treatment of Peripheral Lymphedema. Lymphology 28 
(1995).
    \149\ Lymphedema CDC.gov. https://www.cdc.gov/cancer/survivors/patients/lymphedema.htm.
    \150\ Lymphedema. Bryan C. Sleigh; Biagio Manna, September 2018. 
Found at https://www.ncbi.nlm.nih.gov/books/NBK537239/.
    \151\ https://lymphnet.org/what-is-lymphedema.
    \152\ Korpan MI, Crevenna R, Fialka-Moser V. Lymphedema a 
Therapeutic Approach in the Treatment and Rehabilitation of Cancer 
Patients. American Journal of Physical Medicine and Rehabilitation. 
2011. May. 90(suppl). S69-S75.
    \153\ Preston NJ, Seers K, Mortimer PS. Physical therapies for 
reducing and controlling lymphoedema of the limbs. Cochrane Database 
of Systematic Reviews 2004, Issue 4. Art. No.: CD003141.
    \154\ The International Society of Lymphology. The Diagnosis and 
Treatment of Peripheral Lymphedema: 2020 Consensus Document of the 
International Society of Lymphology. Lymphology. 2020. 53: 3-19.
    \155\ King M, Deveaux A, White H, Rayson. Compression garments 
versus compression bandaging in decongestive lymphatic therapy for 
breast cancer-related lymphedema: a randomized controlled trial. 
Support Care Cancer. 2012; 20: 1031-1036.
    \156\ Korpan MI, Crevenna R, Fialka-Moser V. Lymphedema a 
Therapeutic Approach in the Treatment and Rehabilitation of Cancer 
Patients. American Journal of Physical Medicine and Rehabilitation. 
2011. May. 90(suppl). S69-S75.
    \157\ Warren AG, Brorson H, Borud LJ, Slavin SA. Lymphedema A 
Comprehensive Review. Annals of Plastic Surgery. 2007. Vol 59, No. 
4. 464-472.
    \158\ Ly CL, Kataru RO, Mehrara B. Inflammatory Manifestations 
of Lymphedema. Int J Mol Scie. 2017. Jan; 18(1): 171.
    \159\ Grada AA, Phillips TJ. Lymphedema, Pathophysiology and 
clinical manifestations. J Am Academ Dermatol. 2017;77: 1009-20.
    \160\ Bakar Y, Tugral A. Lower Extremity Lymphedema Management 
after Gynecologic Cancer Surgery: A Review of Current Management 
Strategies. Ann of Vasc Surg. 2017. Vol. 44; 442-450.
    \161\ Warren AG, Brorson H, Borud LJ, Slavin SA. Lymphedema A 
Comprehensive Review. Annals of Plastic Surgery. 2007. Vol 59, No. 
4. 464-472.
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    Lymphedema occurs in four stages. Stage one may have no outward 
signs or symptoms but is evidenced by abnormal flow through the 
lymphatic system. When stage two is reached, there is some swelling 
that may be alleviated by elevation or compression. Stage three is 
diagnosed by swelling of an area that does not resolve with elevation 
and there may be skin thickening and scarring. The fourth stage is 
characterized by severe swelling and skin abnormalities.\162\ 
Infections such as cellulitis and sepsis may result from lymphedema due 
to the dense protein rich nature of the lymphatic fluid and requires 
treatment with antibiotics.\163\ Studies have shown that gradient 
compression garments are effective in reducing and/or preventing 
progression

[[Page 43769]]

of lymphedema in the arm and leg.\164\ They have also shown to be 
effective in maintaining limb circumference.
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    \162\ The Johns Hopkins Hospital https://www.hopkinsmedicine.org/health/treatment-tests-and-therapies/treating-lymphedema.
    \163\ https://www.cancerresearchuk.org/about-cancer/coping/
physically/lymphoedema-and-cancer/infection-
lymphoedema#:~:text=Infection%20in%20people%20with%20lymphoedema,and%
20will%20need%20antibiotic%20treatment.
    \164\ Yasuhara H, Shigematsu H, Muto T. A study of the 
advantages of elastic stockings for leg lymphedema. Int Angiol. 1996 
Sep;15(3):272-7. PMID: 8971591. https://pubmed.ncbi.nlm.nih.gov/8971591/.
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    Gradient compression garments designed for daytime use, while an 
individual is awake, are different than those for nighttime use, when 
an individual is asleep. Gradient compression garments meant for 
daytime (waking) provide a higher level of compression, and use of them 
while sleeping could cause new or additional damage to the affected 
tissue.\165\ Additionally, gradient compression garments appropriate 
for daytime use can inadvertently become repositioned at night while 
the individual is sleeping and cause a tourniquet effect, essentially 
cutting off circulation to the limb and resulting in further 
swelling.\165\ In contrast, gradient compression garments made for 
nighttime use or times of low activity offer milder compression and are 
less snug against the skin.\166\ Wearing gradient compression garments 
designed for nighttime use may also help with skin abnormalities 
resulting from lymphedema and can help prevent a phenomenon called 
``creeping refill,'' where swelling reoccurs during sleep.\167\ 
Generally, more serious cases require gradient compression garments for 
both daytime and nighttime use. Various types of nighttime garments 
have been designed as alternatives to the day time compression system 
garments. Nighttime garments apply gentle gradient pressure to the limb 
through a garment with a foam liner and a series of adjustable straps. 
The garments are non-elastic and provide low resting pressure on the 
limb, making them safe to wear while sleeping at night.\168\ Many of 
these garments are custom-made, but there are ready-to-wear options 
available as well. The elastic fibers of daytime compression garments 
will break down with wear. Because nighttime garments are made of 
inelastic components, compared to the day-time garments, they do not 
commonly break down with wear and last longer. While proper care will 
increase the lifespan of garments, they will need to be replaced 
sometime within 1 to 3 years if used daily. Studies showed if the 
garments are used with aftercare regimen, that is, they are in minimum 
contact with moisturizer during use, they could last longer.\169\ In 
meetings with CMS, some clinicians and lymphologists indicated that 
they believe that the nighttime garments are quite durable and can last 
for 2 to 3 years because the materials are more durable than the 
materials used with the daytime garments. They also indicated that 
previous versions used strapping in addition to more durable foam 
materials and could last for up to 5 years. In comparison, daytime 
garments are elastic garments that are typically made of breathable 
elastic fabrics such as nylon, cotton, spandex or natural rubber to 
provide compression and therefore have a much shorter lifespan of 
approximately 6 months.\170\
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    \165\ Lymphedema Products, LLC. (2019, September 11). Day 
Compression vs Night Compression. Lymphedemaproducts.com. https://www.lymphedemaproducts.com/blog/day-vs-night-compression-wear/.
    \166\ Caring Touch Medical, Inc. Can You Sleep in a Lymphedema 
Sleeve? Caringtouchmed.com. https://www.caringtouchmed.com/can-you-sleep-in-a-lymphedema-sleeve/.
    \167\ Mastectomy Shop. Can You Sleep in a Lymphedema Sleeve? 
Mastectomyshop.com. https://www.mastectomyshop.com/blogs/can-you-sleep-in-a-lymphedema-sleeve/.
    \168\ McNeely, M. L. et al. Nighttime compression supports 
improved self[hyphen]management of breast cancer related lymphedema: 
A multicenter randomized controlled trial. Cancer 128, 587-596 
(2021).
    \169\ Macintyre, Lisa Ph.D.; Gilmartin, Sian BSc; Rae, Michelle 
BSc; Journal of Burn Care & Research: September/October 2007--Volume 
28--Issue 5--pp 725-733.
    \170\ Mukhopadhyay, A., & Shaw, V. P. (2022). Reliability 
analysis of stretchable workwear fabric under abrasive damage: 
Influence of stretch yarn composition. Journal of Natural Fibers, 
20(1).
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    Gradient compression garments are either standard fit or custom-
fit. Standard compression garments are also referred to as ready-made 
or ready-to-wear and are widely available pre-made, off-the-shelf and 
in a range of standard sizes. Individuals with mild or moderate 
lymphedema can often use standard fit garments. Standard gradient 
compression garments are easier to measure and are readily available at 
retailers without requiring a prescription, but they do not conform as 
well to limbs or provide homogenous compression. Standard fit 
compression wear for all gradient compression garments come in 
different compression classification ranges specified in mmHg. While 
there are no national standards for gradient compression hosiery,\171\ 
the most common compression classification ranges for hosiery in the 
U.S. include: 8-15 mmHg (mild), 15-20 mmHg (medium or over the 
counter), 20-30 mmHg (firm or medical class 1), 30-40 mmHg (extra firm 
or medical class 2), and 40-50 mmHg (medical class 3).\172\ For all 
compression ranges, the highest compression is at the ankle or wrist, 
and compression slowly decreases as it moves up the extremity. Some 
manufacturers' compression class pressure ranges for hosiery may be 
different from the compression class ranges used for upper limb 
gradient compression garment.\173\
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    \171\ Lymphedema Framework. Best Practice for the Management of 
Lymphoedema. International Consensus. London. MEP Ltd, 2006. https://www.woundsme.com/uploads/resources/content_11160.pdf.
    \172\ Lymphedema Products, LLC. Determining Compression Levels. 
Lymphedemaproducts.com. https://www.lymphedemaproducts.com/blog/how-to-determine-compression-levels-for-your-garments/.
    \173\ Lympoedema Framework. Best Practice for the Management of 
Lymphoedema. International Consensus. London. MEP Ltd, 2006. https://www.woundsme.com/uploads/resources/content_11160.pdf.
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    Alternatively, custom-fit gradient compression garments are 
garments that are uniquely sized, shaped, and custom-made to fit the 
exact dimensions of the affected extremity (circumferential 
measurements are every one and a half to two inches) and provide more 
accurate and consistent gradient compression to manage the individual's 
symptoms.\174\ The type of gradient compression garment prescribed is 
influenced by the site and extent of the swelling, together with the 
individual's comfort, lifestyle, preferences, and ability to apply and 
remove garments. Poorly fitting gradient compression garments may not 
contain or resolve the lymphedema, can cause tissue damage, may be 
uncomfortable, and can dissuade a patient from long-term usage.\175\
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    \174\ https://www.forwardhealth.wi.gov/kw/html/3485_Compression_Garments.html.
    \175\ Doherty DC, Morgan PA, & Moffatt CJ (2009). Hosiery in 
Lower Limb Lymphedema. J Lymphoedema, 4(1), 30-37. https://www.woundsme.com/uploads/resources/content_11160.pdf.
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    Custom-fit gradient compression garments are typically required 
when an individual has severe shape distortion and/or short, long, or 
bulky limbs.\176\ In addition, individuals with complex lower limb and 
torso lymphedema often require custom-fit gradient compression 
garments, as do those who need special adaptations or when there is 
need for varying levels of pressure within the same garment.\177\ Some 
studies indicate that approximately 50 percent of lymphedema patients 
require custom-fit gradient compression garments versus standard fit 
gradient compression

[[Page 43770]]

garments for effective treatment, although estimates 
vary.178 179 Patients requiring custom-fit gradient 
compression garments must be properly evaluated and fitted by a 
qualified practitioner with appropriate training and specialized skills 
in the evaluation of gradient compression, such as a physical or 
occupational therapist, or a physician.
---------------------------------------------------------------------------

    \176\ Chang M-H, Chang DW, & Patel KM (2022). ``Lymphedema Risk 
Reduction and Management'' in Principles and Practice of Lymphedema 
Surgery, 2nd Ed., 78-90. https://www.sciencedirect.com/topics/medicine-and-dentistry/compression-garment.
    \177\ Doherty DC, Morgan PA, & Moffatt CJ (2009). Hosiery in 
Lower Limb Lymphedema. J Lymphoedema, 4(1), 30-37. https://www.woundsme.com/uploads/resources/content_11160.pdf.
    \178\ Lymphedema Advocacy Group (2021 Apr). ``Cost and 
Utilization of Lymphedema Compression Garments.'' https://lymphedematreatmentact.org/wp-content/uploads/2021/04/Cost-and-Utilization-of-Lymphedema-Compression-Garments.pdf.
    \179\ Boyages J, Xu Y, Kalfa S, Koelmeyer L, Parkinson B, Mackie 
H, Viveros H, Gollan P, & Taksa L (2017). Financial cost of 
lymphedema borne by women with breast cancer. Psychooncology, 26(6), 
849-855. doi: 10.1002/pon.4239. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5484300/.
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3. Current Issues: Scope of the Benefit for Lymphedema Compression 
Treatment Items
    This proposed rule would implement a new benefit category 
established at section 1861(s)(2)(JJ) of the Act for ``lymphedema 
compression treatment items'' defined at section 1861(mmm) of the Act 
as standard and custom fitted gradient compression garments and other 
items determined by the Secretary that are--
     Furnished on or after January 1, 2024, to an individual 
with a diagnosis of lymphedema for the treatment of such condition;
     Primarily and customarily used to serve a medical purpose 
and for the treatment of lymphedema, as determined by the Secretary; 
and
     Prescribed by a physician (or a physician assistant, nurse 
practitioner, or a clinical nurse specialist (as these terms are 
defined in section 1861(aa)(5)) to the extent authorized under State 
law).
    We are proposing that any other items covered under this new 
benefit category in addition to gradient compression garments must also 
use compression in treating lymphedema since the specific category of 
medical items to be covered under section 1861(s)(2) of the Act are 
``lymphedema compression treatment items.'' Similarly, we are proposing 
that this benefit category is limited to compression treatment items 
and does not include professional lymphedema treatment services or 
other services not directly related to the furnishing of the lymphedema 
compression treatment items. Payment for any covered professional 
service related to these items would be made under the Medicare 
Physician Fee Schedule. The statute limits the benefit to items used 
for the treatment of lymphedema as determined by the Secretary, and we 
are proposing that this includes items used to treat all types or 
diagnoses of lymphedema, but does not include the same items when used 
to treat injuries or illnesses other than lymphedema. In other words, 
if a gradient compression garment or other lymphedema compression 
treatment item is furnished to treat an injury or illness other than 
lymphedema, those items would not be classified under the Medicare 
benefit category for lymphedema compression treatment items.
    We are proposing that other compression items used to treat 
lymphedema that would be covered under this benefit category in 
addition to gradient compression garments would include ready-to-wear, 
non-elastic, gradient compression wraps with adjustable straps such as 
the items described by HCPCS code A6545. In addition, we are proposing 
that compression bandaging systems applied in a clinical setting as 
part of phase one decongestive therapy would also be items covered 
under the new benefit category for lymphedema compression treatment 
items if this rule is finalized. However, as discussed in section 
VII.B.6. of this rule, section 1834(j) of the Act, as amended by 
section 4133(b)(2) of the CAA, 2023, requires the therapists that 
furnish these items to become enrolled and accredited DMEPOS suppliers 
in order to bill for these items as lymphedema compression treatment 
items per section 1834(j)(5) of the Act or payment for the items 
applied during phase one of decongestive therapy would not be allowed. 
We also note that while these items may be covered under the new Part B 
benefit for lymphedema compression treatment items, the professional 
services of applying these items would not and would need to be covered 
under a different Medicare benefit category in order for Medicare 
payments to be made for these services. We are specifically soliciting 
comments on the topic of coverage of compression bandaging items under 
the new benefit for lymphedema compression treatment items. We are also 
soliciting comments on whether the professional services of applying 
these bandages could be covered under another Medicare benefit 
category, such as outpatient physical therapy services under section 
1861(p) of the Act or physician services under section 1861(s) of the 
Act.
    With regard to custom garments, we understand that therapists often 
take measurements of affected body areas and perform other fitting 
services related to the furnishing of these items. Since these 
measurements are necessary for the furnishing of the custom garments 
and are part of what makes the garments custom garments rather than 
standard garments, these measurements are an integral part of 
furnishing the custom garments and the suppliers of the garments are 
responsible for fitting the garments they furnish. Typically, DMEPOS 
suppliers are responsible for all aspects of furnishing the item. 
Following that approach, a supplier receiving payment for furnishing a 
lymphedema compression treatment item to a beneficiary has 
responsibility for ensuring that any necessary fitting, training (how 
to appropriately don/doff and maintain), and adjustment services are 
provided as part of furnishing the item. Payment for all services 
necessary for furnishing a gradient compression garment are included in 
the rates paid by the Medicaid State agencies and we are proposing to 
use the average Medicaid payment rate plus twenty percent as the 
payment basis for Medicare (when such Medicaid rates are available). 
Therefore, the Medicare payments would likewise include payment for all 
services necessary for furnishing the gradient compression garment; 
this is consistent with how Medicare payment is made for DMEPOS. We 
understand that in many cases a therapist may take measurements and 
provide other fitting services necessary for furnishing a gradient 
compression garment that is then furnished by a separate supplier. 
Under this scenario, the supplier receiving payment for the garment 
would be responsible for paying the therapist for the fitting component 
that is an integral part of furnishing the item. An alternative option, 
which we are not proposing but are seeking comment on, would be to pay 
separately for the fitting component furnished by the therapist and 
then back this payment out of the payment for the garment. If a 
separate Medicare payment amount was made to an entity other than the 
supplier of the garment for fitting services necessary for furnishing 
the garment, this amount would have to be subtracted from the payment 
to the supplier of the garment in order to avoid paying twice for these 
services. For example, if code Axxx1 describes a ``Gradient compression 
arm sleeve and glove combination, custom, each,'' with a payment amount 
of $350 established for each garment, a supplier furnishing two of 
these garments to a beneficiary for daytime use would receive $700 if 
the garments are furnished on an assignment basis, and part of this 
payment would cover the cost of the fitting of the garment that is 
furnished by the supplier or a separate

[[Page 43771]]

therapist that is then paid by the supplier for the cost of taking the 
fitting measurements. Alternatively, a separate allowance and code 
could be established for the fitting component, such as $80 for Axxx2 
for ``Fitting of gradient compression arm sleeve and glove combination, 
custom, per two garments.'' Under this scenario, it would be necessary 
to back out the payment for the cost of the separate fitting component 
from the payment for the two garments ($700-$80 = $620), since the 
payment for the garments already includes payment for all services 
necessary for furnishing the garment. As a result, the supplier 
furnishing the garments would be paid $310 for each garment rather than 
$350 since they did not conduct the fitting component that is paid for 
separately. We are not proposing this alternative because of many 
complexities. For example, the therapist providing the fitting 
component would be required to become an enrolled DMEPOS supplier, 
accredited for furnishing the garment fitting component, and 
responsible for meeting all of the requirements for being a DMEPOS 
supplier, such as meeting the DMEPOS supplier standards and quality 
standards, obtaining a surety bond, and submitting claims to the 
appropriate DME MAC. As part of the DMEPOS supplier standards, a 
supplier must accept return of substandard items. In cases where a 
mistake is made in measuring and fitting the beneficiary for two custom 
gradient compression garments, resulting in the furnishing and payment 
for custom gradient compression garments that do not properly fit the 
patient, the risk would be assumed by the fitter and not the supplier 
to accept return of the garments and cover the cost of two replacement 
garments. Again, we are not proposing to make separate payment for the 
fitting services under this benefit when furnished by a supplier other 
than the supplier of the garments; however, we are specifically 
soliciting comments on the topic and comments on options to resolve the 
issues we outlined previously. We recognize that there is not 
necessarily a standard industry practice for the fitting and training 
components for furnishing lymphedema compression garments and seek 
comment on whether there are best practices in this space that CMS 
should consider further in the future. We also welcome comment on 
whether any HCPCS level I (Current Procedural Terminology or 
CPT[supreg]) codes may describe the services of the therapist in these 
scenarios.
    Finally, there are accessories such as zippers in garments, liners 
worn under garments or wraps with adjustable straps, and padding or 
fillers that are not compression garments but may be necessary for the 
effective use of a gradient compression garment or wraps with 
adjustable straps. There are also accessories like donning and doffing 
aids for different body parts such as lower limb butlers or foot 
slippers that allow the patients to put on the compression stockings 
with minimum effort and are not used with compression bandaging systems 
or supplies. We are proposing that accessories necessary for the 
effective use of gradient compression garments and gradient compression 
wraps with adjustable straps would also fall under this new benefit for 
lymphedema compression treatment items. For example, a liner that is 
used with a garment because it is needed to prevent skin breakdown 
could be covered under the new benefit because it is necessary for the 
effective use of the garment. We are specifically soliciting comments 
on the topic of coverage of accessories necessary for the effective use 
of gradient compression garment or wraps with adjustable straps, 
including what HCPCS codes should be established to describe these 
items, as well as comments on whether there are additional items other 
than the gradient compression garments, gradient compression wraps with 
adjustable straps, and compression bandaging supplies that could 
potentially fall under the new benefit category for lymphedema 
compression treatment items.
4. Healthcare Common Procedure Coding System (HCPCS) Codes for 
Lymphedema Compression Treatment Items
    HCPCS codes are divided into two principal subsystems, referred to 
as Level I and Level II of the HCPCS. Level I of the HCPCS is comprised 
of Current Procedural Terminology (CPT), a numeric coding system 
maintained by the American Medical Association (AMA). HCPCS Level II is 
a standardized coding system that is used primarily to identify drugs, 
biologicals and non-drug and non-biological items, supplies, and 
services not included in the CPT codes, such as ambulance services and 
DMEPOS when used outside a physician's office. As shown in Table FF-A 
1, there are currently Level II HCPCS codes for compression garments 
(stockings, sleeves, gloves, and gauntlets) and compression wraps with 
adjustable straps that may be used in the treatment of lymphedema and 
other conditions.

[[Page 43772]]

[GRAPHIC] [TIFF OMITTED] TP10JY23.079

[GRAPHIC] [TIFF OMITTED] TP10JY23.080

    The items described by HCPCS codes A6531, A6532, and A6545 are 
covered by Medicare under the Part B benefit for surgical dressings at 
section 1861(s)(5) of the Act, when used in the treatment of an open 
venous stasis ulcer. Total allowed charges for these three codes in 
2022 was approximately $2.5 million, with around $1.9 million for the 
non-elastic, below knee, gradient compression wrap with adjustable 
straps described by code A6545, $500,000 for the below knee, gradient 
compression stocking code A6531, and $100,000 for the below knee, 
gradient compression stocking code A6532. We are not proposing to 
change this policy with this rule, but we must address the codes for 
items when they are covered under Medicare Part B as surgical dressing 
versus when they are covered under Medicare Part B as lymphedema 
compression treatment for billing and claims processing purposes. We 
are therefore proposing to add three new HCPCS codes for use when 
billing for A6531, A6532, and A6545 items used as surgical dressings. 
The proposed codes are as follows:

 A--Gradient compression stocking, below knee, 30-40 mmhg, used 
as surgical dressing in treatment of open venous stasis ulcer, each
 A--Gradient compression stocking, below knee, 40-50 mmhg, used 
as surgical dressing in treatment of open venous stasis ulcer, each
 A--Gradient compression wrap with adjustable straps, non-
elastic, below knee, 30-50 mmhg, used as surgical dressing in treatment 
of open venous stasis ulcer, each

    The surgical dressing fee schedule amounts for codes A6531, A6532, 
and A6545 would be applied to the three new codes. The remaining 
discussion in this section addresses the coding for the lymphedema 
compression treatment items.
    For gradient compression stockings, we are proposing to use 
existing codes A6530 through A6541, and code A6549 from Table FFA-1. 
For codes A6530

[[Page 43773]]

through A6541, we are soliciting comments on whether we should maintain 
the three pressure level differentiations in the codes and whether 
these differentiations should be something other than 18-30, 30-40, and 
40-50 mmHg. We are also soliciting comments on whether there is a 
better way to describe the body areas these garments cover rather than 
``below knee,'' ``thigh-length,'' ``full-length/chap style,'' and 
``waist-length.'' For each code, we propose to add a matching code for 
the custom version of the garment. For example, if we continue to use 
codes A6530 through A6532 for below knee stockings with the current 
descriptions, we would add corresponding codes for the custom versions 
of these garments, such as the following:

 A--Gradient compression stocking, below knee, 18-30 mmhg, 
custom, each
 A--Gradient compression stocking, below knee, 30-40 mmhg, 
custom, each
 A--Gradient compression stocking, below knee, 40-50 mmhg, 
custom, each

    For gradient compression garments for the upper extremities and 
areas of the body, we propose to use existing codes A6549 and S8420 
through S8428. We propose renumbering codes S8420 through S8428 as 
``A'' codes rather than S codes. We also propose removing the words 
``ready-made'' and revising ``custom made'' to ``custom'' for the codes 
for the upper extremity gradient compression garments and replacing the 
word ``pressure'' with ``compression,'' in order to be consistent with 
the wording for the codes for the lower extremity garments. We propose 
to add the word ``arm'' in front of the word ``sleeve'' for the upper 
extremity garments. We also propose to add a code for a custom 
gauntlet. Finally, we propose to add the word ``each'' to the 
description for each code. If no other changes are made, the new codes 
would be as follows:

 --Gradient compression arm sleeve and glove combination, each
 A--Gradient compression arm sleeve and glove combination, 
custom, each
 A--Gradient compression arm sleeve, each
 A--Gradient compression arm sleeve, custom, medium weight, 
each
 A--Gradient compression arm sleeve, custom, heavy weight, each
 A--Gradient compression glove, each
 A--Gradient compression glove, custom, medium weight, each
 A--Gradient compression glove, custom, heavy weight, each
 A--Gradient compression gauntlet, each
 A--Gradient compression gauntlet, custom, each

    We are soliciting comment on whether separate codes are needed for 
mastectomy sleeves or whether these items can be grouped together under 
the same codes used for other arm sleeves (S8422 thru S8424). We are 
soliciting comments on whether there is a need to retain codes S8420 
through S8428, in addition to the renumbered A code versions, for use 
by other payers other than Medicare. If these codes are retained, they 
would be invalid for Medicare use, but could be used by other payers in 
lieu of the new A codes.
    We are also proposing to add the following new codes for other 
upper body areas:

 A--Gradient compression garment, neck/head, each
 A--Gradient compression garment, neck/head, custom, each
 A--Gradient compression garment, torso and shoulder, each
 A--Gradient compression garment, torso/shoulder, custom, each
 A--Gradient compression garment, genital region, each
 A--Gradient compression garment, genital region, custom, each

    For all of the codes for the upper extremities and upper body 
areas, we are soliciting comments on whether we should establish codes 
for pressure level differentiations similar to the pressure level 
differentiations in codes A6530 through A6541, possibly replacing the 
words medium and heavy weight, as well as whether codes are needed for 
additional upper body areas.
    We are proposing the following new codes for nighttime garments:

 A--Gradient compression garment, glove, padded, for nighttime 
use, each
 A--Gradient compression garment, arm, padded, for nighttime 
use, each
 A--Gradient compression garment, lower leg and foot, padded, 
for nighttime use, each
 A--Gradient compression garment, full leg and foot, padded, 
for nighttime use, each

    For gradient compression wraps with adjustable straps, we are 
proposing to use code A6545 in Table FF-A 1 for below knee wraps and 
solicit comments on whether additional codes or coding revisions are 
needed for the purpose of submitting claims for gradient compression 
wraps with adjustable straps. Regarding HCPCS codes for compression 
bandaging systems, we believe more codes are needed than existing codes 
S8430 (Padding for compression bandage, roll) and S8431 (Padding for 
compression bandage, roll), for example, to describe the supplies used 
in a compression bandaging system consisting of more than two layers. 
We also believe that specific base sizes should be added to the code, 
for example ``10cm by 2.9m'' rather than the vague unit of ``roll'' and 
are soliciting comments on HCPCS coding changes needed to adequately 
describe the various compression bandaging systems used for the 
treatment of lymphedema. Finally, as noted in section VII.B.3. of this 
rule, we are soliciting comments on HCPCS codes needed to describe 
accessories necessary for the effective use of gradient compression 
garments or wraps with adjustable straps.
5. Procedures for Making Benefit Category Determinations and Payment 
Determinations for New Lymphedema Compression Treatment Items
    We are proposing to implement the new Part B benefit for lymphedema 
compression treatment items and the initial set of HCPCS codes to 
identify these items for claims processing purposes, effective January 
1, 2024. In the future, as new products come on the market and 
refinements are made to existing technology, there will be a need to 
determine whether these newer technology items are lymphedema 
compression treatment items covered under this new benefit and what 
changes to the HCPCS are needed to identify these items for claims 
processing purposes. There will also be a need to establish payment 
amounts for the newer items in accordance with the payment rules 
established as part of this rulemaking.
    Currently, CMS uses the procedures at 42 CFR 414.114 to make 
benefit category determinations and payment determinations for new 
splints and casts, parenteral and enteral nutrition (PEN) items and 
services covered under the prosthetic device benefit, and intraocular 
lenses (IOLs) inserted in a physician's office covered under the 
prosthetic device benefit. CMS uses the same procedures at 42 CFR 
414.240 to make benefit category determinations and payment 
determinations for new DME items and services, prosthetics and 
orthotics, surgical dressings, therapeutic shoes and inserts, and other 
prosthetic devices other than PEN items and services and IOLs inserted 
in a physician's office. These procedures involve the use of the HCPCS 
public meetings where consultation from the public is obtained on 
preliminary HCPCS coding determinations for new items and services. 
Public consultation is also obtained at these meetings on

[[Page 43774]]

preliminary benefit category determinations and preliminary payment 
determinations for the new items and services. To ensure appropriate 
and timely consideration of future items that may qualify as lymphedema 
compression treatment items, we are proposing to use these same 
procedures to make benefit category determinations and payment 
determinations for new lymphedema compression treatment items. Future 
changes to the HCPCS codes established in section 2 of this rule for 
lymphedema compression treatment items would also be made using this 
public meeting process.
    We are proposing to use the same process described in Sec.  414.240 
to obtain public consultation on preliminary coding, benefit category, 
and payment determinations for new lymphedema compression treatment 
items. That is, when a request is received for a new HCPCS code or 
change to an existing HCPCS code(s) for a lymphedema compression 
treatment item, CMS would perform an analysis to determine if a new 
code or other coding change is warranted and if the item meets the 
definition of lymphedema compression treatment item at section 
1861(mmm) of the Act. A preliminary payment determination would also be 
developed for items determined to be lymphedema compression treatment 
items and are implemented in April or October of each year. The 
preliminary determinations would be posted on CMS.gov approximately 2 
weeks prior to a public meeting. As part of this coding and payment 
determination process, it may be necessary to combine or divide 
existing codes; in this situation, we are proposing to follow the same 
process as outlined in 42 CFR 414.236. After consideration of public 
input on the preliminary determinations, CMS would post final HCPCS 
coding decisions, benefit category determinations, and payment 
determinations on CMS.gov, and then issue program instructions to 
implement the changes.
    In addition to these proposals for initial payment determinations 
for lymphedema treatment items and the proposed process for addressing 
new lymphedema treatment items, as required by the Act, we also propose 
to revise the DMEPOS regulations to include lymphedema treatment items 
in the competitive bidding process. We are proposing changes to 42 CFR 
414.402 to add lymphedema treatment items to the definition of 
``items'' for competitive bidding, Sec.  414.408 to include lymphedema 
treatment items in the list of items for which payment would be made on 
a lump sum purchase basis under the competitive bidding program in 
accordance with any frequency limitations established under proposed 
subpart Q in accordance with section 1834(z)(2) of the Act, and Sec.  
414.412 to add reference to the proposed subpart Q to the bid rules.
6. Enrollment, Quality Standards, and Accreditation Requirements for 
Suppliers of Lymphedema Compression Treatment Items and Medicare Claims 
Processing Contractors for These Items
    Section 1834(a)(20) of the Act requires the establishment of 
quality standards for suppliers of DMEPOS that are applied by 
independent accreditation organizations. Section 4133(b)(1) of the CAA, 
2023 amends section 1834(a)(20)(D) of the Act to apply these 
requirements to lymphedema compression treatment items as medical 
equipment and supplies.
    Section 1834(j) of the Act requires that suppliers of medical 
equipment and supplies obtain and continue to periodically renew a 
supplier number in order to be allowed to submit claims and receive 
payment for furnishing DMEPOS items and services. The suppliers must 
meet certain supplier standards in order to possess a supplier number 
and are also subject to other requirements specified in section 1834(j) 
of the Act. Section 4133(b)(2) of the CAA, 2023 amends section 
1834(j)(5) of the Act to include lymphedema compression treatment items 
as medical equipment and supplies subject to the requirements of 
section 1834(j) of the Act.
    Suppliers of DMEPOS meeting the requirements of sections 
1834(a)(20) and 1834(j) of the Act, and related implementing 
regulations at 42 CFR 424.57 must enroll in Medicare or change their 
enrollment using the paper application Medicare Enrollment Application 
for DMEPOS Suppliers (CMS-855S) or through the Medicare Provider 
Enrollment, Chain, and Ownership System (PECOS). For more information 
on supplier enrollment, go to: https://www.cms.gov/medicare/provider-enrollment-and-certification/become-a-medicare-provider-or-supplier.
    Regulations at 42 CFR 421.210 establish regional contractors to 
process Medicare claims for DMEPOS items and services. These 
contractors are known as Durable Medical Equipment Medicare 
Administrative Contractors (DME MACs). We are proposing to include 
lymphedema compression treatment items as DMEPOS items that fall within 
the general text of section 421.210(b)(7) for other items or services 
which are designated by CMS. Thus, claims for these items would be 
processed by the DME MACs.
7. Payment Basis and Frequency Limitations for Lymphedema Compression 
Treatment Items
    Section 1834(z)(1) of the Act mandates an appropriate payment basis 
for lymphedema compression treatment items defined in section 1861(mmm) 
of the Act and specifically identifies payment rates from other 
government and private sector payers that may be taken into account in 
establishing the payment basis for these items. These sources include 
payment rates used by Medicaid state plans, the Veterans Health 
Administration (VHA), group health plans, and health insurance coverage 
(as defined in section 2791 of the Public Health Service Act). Section 
1834(z)(1) of the Act also indicates that other information determined 
to be appropriate may be taken into account in establishing the payment 
basis for lymphedema compression treatment items.
    Based on our research, Medicaid state plans generally classify and 
provide lymphedema compression treatment items in the same manner as 
other durable medical equipment and supplies for home health. While 
State Medicaid Director Letter #18-001 focuses on how states may 
demonstrate compliance with the restriction on claiming federal 
financial participation for ``excess'' durable medical equipment 
spending, it describes how Medicaid state plan payment for the broader 
category of such items (outside of a managed care contract) is usually 
made either through established fee schedules, a competitive bidding 
process of the state's design, or through a manual pricing methodology 
based on the invoice submitted with each claim.\180\ For the purpose of 
this proposed rule, we took into account the average Medicaid fee 
schedule payment amounts across all states that have published fee 
schedule amounts for these items in developing, in part, an appropriate 
payment basis for lymphedema compression treatment items under 
Medicare.
---------------------------------------------------------------------------

    \180\ Available at https://www.medicaid.gov/federal-policy-guidance/downloads/smd18001.pdf
---------------------------------------------------------------------------

    The VHA does not have established fee schedules for lymphedema 
compression treatment items, but rather follows a policy of paying for 
these items based on the reasonableness of vendor pricing. Based on our 
conversations with the VHA, we understand that for these items, vendor 
prices at or below acquisition cost plus 50 percent is typically 
considered

[[Page 43775]]

reasonable, while Medicaid state plans typically pay for DMEPOS items 
that do not have fee schedule amounts at acquisition cost plus 20 to 30 
percent. Given this difference in the allowed supplier margin, the 
amounts determined to be reasonable payment rates for these items by 
the VHA may be approximated by increasing the average Medicaid payment 
rate by 20 to 30 percent. While the VHA may not have fee schedule 
amounts for these items, the Department of Defense's TRICARE system 
maintains fee schedule amounts for lower-extremity lymphedema 
compression garments. These amounts are approximately equal to the 
average Medicaid fee schedule amount plus 20 percent. We therefore 
believe that the average Medicaid fee schedule amount plus 20 percent 
represents what other government payers such as the VHA and TRICARE 
consider an appropriate payment basis for these items and a slightly 
higher payment basis than the average payment rates established by 
Medicaid state plans that have fee schedule amounts for these items; we 
are specifically soliciting comments on this. We also conducted a 
search of internet prices for lymphedema compression treatment items 
and found these prices to be in line with the TRICARE fee schedule 
amounts and average Medicaid fee schedule amounts plus 20 percent. We 
believe that appropriate payment amounts for Medicare for lymphedema 
compression treatment items would be payment amounts that approximate 
the payment rates determined to be reasonable by other government 
payers such as TRICARE, State Medicaid agencies, and, as previously 
explained, estimates of the payment rates determined to be reasonable 
by the VHA based on 120 percent of the average Medicaid state plan 
rates. Because these rates are in line with internet retail prices, we 
have not closely examined non-government payers.
    Having taken into account the payment amounts from the various 
sources, as previously described, as required by Act, we propose to set 
payment amounts for lymphedema compression treatment items using the 
following methodology. Where Medicaid state plan payment amounts are 
available for a lymphedema compression treatment item, we propose to 
set payment amounts at 120 percent of the average of the Medicaid 
payment amounts for the lymphedema compression treatment item. Where 
Medicaid payment amounts are not available for an item, we propose to 
set payment amounts at 100 percent of the average of internet retail 
prices and payment amounts for that item from TRICARE. Where payment 
amounts are not available from Medicaid state plans or TRICARE for a 
given lymphedema compression treatment item, we propose to base payment 
amounts based on 100 percent of average internet retail prices for that 
item. We seek comment on these payment methodologies and whether 
further adjustments are appropriate.
    As previously noted, payment rates for the supply of these items 
includes payment for fitting services and any other services necessary 
for furnishing the item. As noted earlier, taking measurements of 
affected body areas and other fitting services necessary for furnishing 
lymphedema compression treatment items are an integral part of 
furnishing the items and the suppliers receiving payment for furnishing 
lymphedema compression treatment items are responsible for ensuring 
that any necessary fitting services are provided as part of furnishing 
the items.
    The following table presents a preliminary example of what payment 
amounts may be, based on the proposed methodology described, as 
previously detailed, and certain HCPCS codes that we are proposing to 
be classified under the Medicare Part B benefit category for lymphedema 
treatment items.
[GRAPHIC] [TIFF OMITTED] TP10JY23.081


[[Page 43776]]


[GRAPHIC] [TIFF OMITTED] TP10JY23.082

    Where new items are added to this benefit category, following the 
process outlined in section 3 of this section of this rule, the data 
sources (Medicaid, TRICARE, VHA, or internet prices) may not initially 
be available for establishing an appropriate payment amount. We are 
proposing that in this situation, until the data necessary for 
establishing the payment amount becomes available, the DME MACs would 
consider what an appropriate payment amount would be for each item on 
an individual, claim-by-claim basis and may consider using pricing for 
similar items that already have established payment amounts.
    Section 1834(z)(2) of the Act authorizes the establishment of 
frequency limitations for lymphedema compression treatment items and 
specifies that no payment may be made for lymphedema compression 
treatment items furnished other than at a frequency established in 
accordance with this provision of the Act. Gradient compression 
garments are designed differently depending on whether for daytime or 
nighttime use. Those meant for daytime provide a higher level of 
compression while those for nighttime offer milder compression and are 
less snug against the skin. We are seeking comment on our proposal to 
cover and make payment for two garments or wraps with adjustable straps 
for daytime use (one to wear while another is being washed), per 
affected extremity, or part of the body, to be replaced every 6 months 
or when the items is lost, stolen, or irreparably damaged, or if needed 
based on a change in the beneficiary's medical or physical condition 
such as an amputation, complicating injury or illness, or a significant 
change in body weight. In order to maintain mobility, patients may 
require separate garments or wraps above and below the joint of the 
affected extremity or part of the body. As discussed in section B of 
this section of this rule, nighttime garments are inelastic and more 
durable than the elastic daytime garments and we believe it would be 
appropriate to replace these garments once per year. We are proposing 
to cover one nighttime garment per affected extremity or part of the 
body to be replaced once a year or when the garment is lost, stolen, or 
irreparably damaged, or if needed based on a change in the 
beneficiary's medical or physical condition such as an amputation, 
complicating injury or illness, or a significant change in body weight. 
Lymphedema is a chronic condition that can be stabilized if properly 
treated. It may also worsen as the result of infection, radiation and 
chemotherapy, or progression of comorbid conditions such as obesity. At 
this point, patients may require changes in their garment prescription. 
Such changes due to medical necessity will not be subject to the 
frequency limitations, as previously described. In addition, as with 
other DMEPOS items, payment could be made for replacement of garments 
and other items when they are lost, stolen, or irreparably damaged. 
Examples of lost items include items left behind after evacuating due 
to a disaster like a hurricane or tornado. Examples of irreparably 
damaged items include items that burn in a fire, are exposed to toxic 
chemicals, or are damaged by some other event and does not include 
items that wear out over time.
    With regard to replacement frequencies for compression bandaging 
systems and supplies, the weekly frequency and overall length of phase 
one (active) treatment is dependent on the severity of lymphedema. Some 
patients may require treatment 4 to 5 days per week in phase one while 
others may only need treatment 2 to 3 days per week. Bandages are used 
following some form of hands-on decompression to maintain the 
reduction. Therefore, we are not proposing specific replacement 
frequencies for the compression bandaging systems and supplies. We are 
proposing that the DME MACs would make determinations regarding whether 
the quantities of compression bandaging supplies furnished and billed 
during phase one of treatment of the beneficiary's lymphedema are 
reasonable and necessary.
    As previously discussed, section 4133(a)(3) of the CAA, 2023 adds 
subparagraph D to section 1847(a)(2) of the Act to add lymphedema 
compression treatment items to the DMEPOS competitive bidding program. 
Section 1834(z)(3)(A) of the Act specifies that the payment basis under 
section 1847(a) of the Act becomes the payment basis for lymphedema 
compression treatment items furnished under the competitive bidding 
program. Section 1834(z)(3)(B) of the Act provides authority to use 
information on the payment determined for these items under the 
competitive bidding program to adjust the payment amounts otherwise 
determined under section 1834(z) for an area that is not a competitive 
bidding area under section 1847 of the Act, and in the case of such 
adjustment, section 1842(b)(8) and (9) of the Act shall not be applied.
8. Proposed Changes
    We are proposing to amend 42 CFR 410.36 to add paragraph (a)(4) for 
lymphedema compression treatment items as a new category of medical 
supplies, appliances, and devices covered and payable under Medicare 
Part B, including: standard and custom fitted gradient compression 
garments; gradient compression wraps with adjustable straps; 
compression bandaging systems; other items determined to be lymphedema 
compression treatment items under the process established under Sec.  
414.1670; and accessories such as zippers in garments, liners worn 
under garments or wraps with adjustable straps, and padding or fillers 
that are necessary for the effective use of a gradient compression 
garment or wrap with adjustable straps. In order to maintain mobility, 
patients may require separate garments or wraps above and below the 
joint of the affected extremity or part of the body, and we are 
proposing that payment may be made in these circumstances. We are 
proposing that payment may be made for multiple garments used on 
different parts of the body when the multiple garments are determined 
to be reasonable and necessary for the treatment of lymphedema. For 
example, if it is determined that a beneficiary needs three daytime 
garments to cover one

[[Page 43777]]

affected area for the treatment of lymphedema, Medicare would pay for 
two sets of those three garments for that specific affected area, as 
well as any other areas of the body affected by lymphedema. For the 
purpose of establishing the scope of the benefit for these items, we 
are seeking comment on the following definitions we are proposing to 
add to 42 CFR 410.2 as they apply to lymphedema compression treatment 
items:
    Gradient compression means the ability to apply a higher level of 
compression or pressure to the distal (farther) end of the limb or body 
part affected by lymphedema with lower, decreasing compression or 
pressure at the proximal (closer) end of the limb or body part affected 
by lymphedema.
    Custom fitted gradient compression garment means a garment that is 
uniquely sized and shaped to fit the exact dimensions of the affected 
extremity or part of the body of an individual to provide accurate 
gradient compression to treat lymphedema.
    The proposed definition of ``gradient compression'' would apply to 
all lymphedema compression treatment items (garments, wraps, etc.) that 
utilize gradient compression in treating lymphedema. The proposed 
definition of ``custom fitted gradient compression garment'' would 
apply to custom fitted gradient compression garments covered under the 
new benefit category for lymphedema compression treatment items. We 
believe these definitions are necessary for establishing the scope of 
this new benefit.
    Lymphedema compression treatment item means standard and custom 
fitted gradient compression garments and other items specified under 
Sec.  410.36(a)(4) that are--
     Furnished on or after January 1, 2024, to an individual 
with a diagnosis of lymphedema for treatment of such condition;
     Primarily and customarily used to serve a medical purpose 
and for the treatment of lymphedema; and
     Prescribed by a physician (or a physician assistant, nurse 
practitioner, or a clinical nurse specialist (as those terms are 
defined in section 1861(aa)(5) of the Social Security Act) to the 
extent authorized under State law.
    We are proposing to modify and add to the existing HCPCS codes for 
surgical dressings and lymphedema compression treatment items as 
explained in section VII.B.4. of this rule. We are proposing that 
future changes to the HCPCS codes for these items based on external 
requests for changes to the HCPCS or internal CMS changes would be made 
through the HCPCS public meeting process described at: https://www.cms.gov/medicare/coding/medhcpcsgeninfo/hcpcspublicmeetings.
    We are proposing to add Sec.  414.1670 under new subpart Q and use 
the same process described in Sec.  414.240 to obtain public 
consultation on preliminary benefit category determinations and payment 
determinations for new lymphedema compression treatment items. The 
preliminary determinations would be posted on CMS.gov in advance of a 
public meeting. After consideration of public input on the preliminary 
determinations, CMS would post final HCPCS coding decisions, benefit 
category determinations, and payment determinations on CMS.gov, and 
then issue program instructions to implement the changes.
    We are proposing to add a new subpart Q under the regulations at 42 
CFR part 414 titled, ``Payment for Lymphedema Compression Treatment 
Items'' to implement the provisions of section 1834(z) of the Act. We 
are proposing to add Sec.  414.1600 to our regulations explaining the 
purpose and definitions under the new subpart Q. We are proposing to 
add Sec.  414.1650 and paragraph (a) to establish the payment basis 
equal to 80 percent of the lesser of the actual charge for the item or 
the payment amounts established for the item under paragraph (b). We 
are proposing under Sec.  414.1650(b) to establish the payment amounts 
for lymphedema compression treatment items based on the average of 
state Medicaid fee schedule amounts plus 20 percent. Where Medicaid 
rates are not available, we are proposing to use the average of average 
internet retail prices and payment amounts established by TRICARE (or, 
where there is no TRICARE fee schedule rate, the average of internet 
retail prices alone). We propose under Sec.  414.1650(c) that, 
beginning January 1, 2025, and on January 1 of each subsequent year, 
the Medicare payment rates established for these items in accordance 
with section 1834(z)(1) of the Act and Sec.  414.1650(b) would be 
increased by the percentage change in the Consumer Price Index for All 
Urban Consumers (CPI-U) for the 12-month period ending June of the 
preceding year. For example, effective beginning January 1, 2025, the 
payment rates that were in effect on January 1, 2024 would be increased 
by the percentage change in the CPI-U from June 2023 to June 2024.
    We are also proposing to add Sec.  414.1660 to address continuity 
of pricing when HCPCS codes for lymphedema compression treatment items 
are divided or combined. Similar to current regulations at 42 CFR 
414.110 and 414.236, we propose that when there is a single HCPCS code 
that describes two or more distinct complete items (for example, two 
different but related or similar items), and separate codes are 
subsequently established for each item, the payment amounts that 
applied to the single code continue to apply to each of the items 
described by the new codes. We propose that when the HCPCS codes for 
several different items are combined into a single code, the payment 
amounts for the new code are established using the average (arithmetic 
mean), weighted by allowed services, of the payment amounts for the 
formerly separate codes.
    We are proposing to add Sec.  414.1680 and the following frequency 
limitations for lymphedema compression treatment items established in 
accordance with section 1834(z)(2) of the Act under new subpart Q:
     Two daytime garments or wraps with adjustable straps for 
each affected limb or area of the body, replaced every 6 months.
     One nighttime garment for each affected limb or area of 
the body, replaced once a year.
    We are soliciting comments on whether two nighttime garments should 
be allowed, with both garments being replaced once every 2 years, to 
allow for more than 1 day for washing and drying of the garment(s). We 
are also proposing to cover replacements of garments or wraps that are 
lost, stolen, irreparably damaged, or when needed due to a change in 
the patient's medical or physical condition. We are not proposing 
specific replacement frequencies for compression bandaging systems or 
supplies. We are proposing that determinations regarding the quantity 
of compression bandaging supplies covered for each beneficiary during 
phase one of decongestive therapy would be made by the DME MAC that 
processes the claims for the supplies.
    We are proposing to revise the regulations for competitive bidding 
under subpart F at 42 CFR 414 to include lymphedema compression 
treatment items under the competitive bidding program as mandated by 
section 1847(a)(2)(D) of the Act. We propose to modify the list of 
items that may be included in competitive bidding described in Sec.  
414.402 to include lymphedema treatment items and revise Sec.  414.408 
to include lymphedema treatment items in the list of items for which 
payment would be made on a lump sum purchase basis under the 
competitive bidding program in accordance with any frequency 
limitations established under proposed

[[Page 43778]]

subpart Q in accordance with section 1834(z)(2) of the Act. Finally, we 
propose to add reference the proposed subpart Q to the bid rules 
described at Sec.  414.412.
    The methodologies for adjusting DMEPOS payment amounts for items 
included in the DMEPOS Competitive Bidding Program (CBP) that are 
furnished in non-CBAs based on the payments determined under the DMEPOS 
CBP are set forth at Sec.  414.210(g). Section 4133(a)(3) of the CAA, 
2023 amended section 1847(a)(2) of the Act to include lymphedema 
compression treatment items under the DMEPOS CBP, and section 
4133(a)(2) of the CAA, 2023 amended section 1834 of the Act to provide 
authority to adjust the payment amounts established for lymphedema 
compression treatment items in accordance with new subsection z based 
on the payments determined for these items under the DMEPOS CBP. We 
believe the methodologies for adjusting DMEPOS payment amounts at Sec.  
414.210(g) should also be used to adjust the payment amounts for 
lymphedema compression treatment items included in the DMEPOS CBP that 
are furnished in non-CBAs. We see no reason why different methodologies 
for adjusting payment amounts based on payments determined under the 
DMEOPS CBP would need to be established for lymphedema compression 
treatment items. We are therefore proposing to add Sec.  414.1690 
indicating that the payment amounts established under Sec.  414.1650(b) 
for lymphedema compression treatment items may be adjusted using 
information on the payment determined for lymphedema compression 
treatment items as part of implementation of the DMEPOS CBP under 
subpart F using the methodologies set forth at Sec.  414.210(g).

C. Definition of Brace

1. Background
    The Social Security Act of 1965 (the Act) defines the scope of 
benefits available to eligible Medicare beneficiaries under Medicare 
Part B, the voluntary supplementary medical insurance program defined 
by section 1832 of the Act. Section 1832(a)(1) of the Act establishes 
the Medicare Part B benefit for ``medical and other health services.'' 
Section 1861(s) of the Act further defines ``medical and other health 
services'' to include under paragraph (9) leg, arm, back, and neck 
braces, and artificial legs, arms, and eyes. Artificial legs, arms, and 
eyes are artificial replacements for missing legs, arms, and eyes and 
this rule does not address the scope of the Medicare benefit for these 
items. Section 1834(h)(4)(C) of the Act details the payment rules for 
particular items and services including specifying that ``the term 
`orthotics and prosthetics' has the meaning given to such term in 
section 1861(s)(9).'' Regulations at 42 CFR 410.36(a)(3) include leg, 
arm, back, and neck braces under the list of medical supplies, 
appliances, and devices in the scope of items paid for under Part B of 
Medicare. However, the term ``brace'' is not defined in the Act or in 
regulation. Specifically, the term brace is not defined in 42 CFR 410.2 
Definitions for supplementary medical insurance benefits for Medicare.
    The Medicare program instruction that defines the term brace is 
located at CMS Pub. 100-02, Chapter 15, Sec.  130 of the Medicare 
Benefit Policy Manual for Part B coverage of ``Leg, Arm, Back, and Neck 
Braces, Trusses, and Artificial Legs, Arms, and Eyes.'' Within this 
instruction, braces are defined as ``rigid and semi-rigid devices which 
are used for the purpose of supporting a weak or deformed body member 
or restricting or eliminating motion in a diseased or injured part of 
the body.'' The Medicare definition of brace in program instructions 
dates back to the 1970s and was previously located in the Medicare 
Carriers Manual, HCFA Pub. 14, Part III, Chapter 2, Sec.  2133. This 
longstanding definition of brace in our program instructions is used 
for the purpose of making benefit category determinations in accordance 
with the procedures located at 42 CFR 414.240 (86 FR 73911) regarding 
when a device constitutes or does not constitute a leg, arm, back, or 
neck brace for Medicare program purposes.
2. Current Issues
    We believe that adding the definition of brace to the regulations 
at 42 CFR 410.2 is necessary for describing the scope of the Medicare 
Part B benefit for leg, arm, back, and neck braces. We believe that 
codifying the definition that is currently located in Medicare program 
instructions would continue the efficiency of the administration of the 
Medicare program by providing clarity and transparency regarding the 
scope of the benefit, for example, whether a specific device is a leg, 
arm, back, or neck brace as defined in section 1861(s)(9) of the Act, 
and consequently, payment determinations for such items. We also 
believe that adding the definition of brace to the regulations would 
support our benefit category determination process described in 42 CFR 
414.240 (86 FR 73911).
    The orthopedic industry has long established the attributes of a 
``brace.'' We believe the definition of a brace in CMS Pub 100-02, 
Chapter 15, Sec.  130 adequately captures the attributes of a brace. 
The words ``rigid'' and ``semi-rigid'' are used to describe the 
stiffness of a material. Rigid materials are used to eliminate motion 
but also to support underload. Components of a brace can use semi-rigid 
materials, which intentionally allow some amount of motion as compared 
to materials that completely immobilize a part of the body. Braces are 
typically prescribed to patients during the process of recovery and 
rehabilitation in order to stop limbs, joints, or specific body 
segments from moving for a pre-determined period. Braces may also be 
prescribed for ongoing medical problems that require restriction or 
limitation of joint movement; removal of weight or pressure from 
healing or injured joints, muscles, or body parts; or reduction of 
misalignment and function to reduce pain and facilitate improved 
mobility. 181 182
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    \181\ Webster, J., Murphy, D., 2019, Atlas of Orthoses and 
Assistive Devices, 5th Edition, Elsevier, Philadelphia, PA. (Chapter 
1) https://www.sciencedirect.com/book/9780323483230/atlas-of-orthoses-and-assistive-devices
    \182\ CHAMPVA OPERATIONAL POLICY MANUAL: CHAPTER: 2, SECTION: 
17.4. https://www.vha.cc.va.gov/system/templates/selfservice/va_ssnew/help/customer/locale/en-US/portal/554400000001036/content/554400000008979/021704-ORTHOTICS
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    In order for a brace to properly function, it must utilize a three-
point pressure system to provide angular control over anatomical 
joints.183 184 185 A three-point pressure system places a 
single force at the area of the deformity, while two counter forces act 
in the opposing direction. This pressure system requires that a brace 
be rigid or semi-rigid in structure to apply sufficient relevant force 
to support, restrict, or eliminate motion of the joint or specific body 
part. The rigidity level of a brace is dependent on the body part and 
purpose for which the brace is used. For example, a fully rigid brace 
is used to eliminate motion and support underload. We believe the 
definition of brace in CMS Pub 100-02, Chapter 15, Sec.  130, and our 
proposed definition of

[[Page 43779]]

brace, adequately captures the various attributes of a brace.
---------------------------------------------------------------------------

    \183\ Webster, J., Murphy, D., 2019, Atlas of Orthoses and 
Assistive Devices, 5th Edition, Elsevier, Philadelphia, PA. (Chapter 
18). https://www.sciencedirect.com/book/9780323483230/atlas-of-orthoses-and-assistive-devices
    \184\ Chalmers, D. D., & Hamer, G. P. (1985). Three-point 
dynamic orthosis. Prosthetics and Orthotics International, 9(2), 
115-116. https://journals.sagepub.com/doi/pdf/10.3109/03093648509164718. https://journals.sagepub.com/doi/pdf/10.3109/03093648509164718. https://journals.sagepub.com/doi/pdf/10.3109/03093648509164718. https://journals.sagepub.com/doi/pdf/10.3109/03093648509164718.
    \185\ Article--Spinal Orthoses: TLSO and LSO--Policy Article 
(A52500) (cms.gov).
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    It is important to note that a rigid or semi-rigid device may look 
like a brace in that it has metal struts, joints, and cuffs that go 
over a limb, but may be used for purposes other than bracing the limb. 
We believe that devices used for purposes other than supporting a weak 
or deformed body member or restricting or eliminating motion of a 
diseased or injured part of the body do not fall within the definition 
of a brace in accordance with Pub 100-02, Chapter 15, Sec.  130 
Medicare Benefit Policy Manual, and would not fall within our proposed 
definition of brace. However, items that are not braces may meet the 
Medicare Part B definition for durable medical equipment (DME) at 42 
CFR 414.202. For example, continuous passive motion devices are covered 
as DME in accordance with CMS Pub 100-03, Chapter 1, Part 4, Sec.  
280.1 of the Medicare National Coverage Determinations Manual to 
rehabilitate the knee to increase range of motion following surgery. 
During continuous passive motion therapy, the joint area is secured to 
the device, which then moves the affected joint through a prescribed 
range of motion for an extended period of time. Continuous passive 
motion devices have metal struts, joints, and cuffs that go over a limb 
but are not used for the purpose of restricting or eliminating motion 
in a diseased or injured part of the body or to support a weak or 
deformed body member. While these devices do not meet the definition of 
a brace in accordance with Pub 100-02, Chapter 15, Sec.  130 of the 
Medicare Benefit Policy Manual, they are covered by Medicare as DME. 
Similarly, dynamic adjustable extension/flexion devices and static 
progressive stretch devices are used to stretch an arm or leg or other 
part of the body to treat contractures and increase range of motion. 
While these devices may look similar to a brace, they are used for the 
purpose of treating contractures and are not used for the purpose of 
supporting a weak or deformed body member or restricting or eliminating 
motion in a diseased or injured part of the body. As a result, dynamic 
adjustable extension/flexion devices and static progressive stretch 
devices do not fall under the definition of brace in accordance with 
CMS Pub 100-02, Chapter 15, Sec.  130, but are covered by Medicare as 
DME.
    It is also important to note that although braces in the past have 
typically not included powered devices or devices with power features, 
technology has evolved to include newer technology devices with power 
features designed to assist with traditional bracing functions. For 
example, effective January 1, 2020, code L2006 was added to the HCPCS 
for a knee ankle foot device, any material, single or double upright, 
swing and stance phase microprocessor control with adjustability, 
includes all components (for example, sensors, batteries, charger), any 
type activation, with or without ankle joint(s), custom fabricated). 
CMS classified this device as a brace because it supports a weak or 
deformed knee by preventing it from buckling under the patient. This 
brace includes a microprocessor controlled hydraulic swing and stance 
control knee joint that restricts/affects knee joint kinematics during 
the swing and stance phases of the gait cycle. There are also powered 
brace exoskeleton devices that support a patient's weak arms or legs 
and have been classified as DME in the past. We determined that these 
devices should be classified as braces due to their use in stabilizing, 
positioning, supporting and restoring the function of a patient's weak 
limbs. In addition, upper extremity powered exoskeleton devices used by 
patients with chronic arm weakness such as from complications of stroke 
or other neurological/neuromuscular injury and illness to support and 
assist movement of weak arms were recently introduced to the market. 
HCPCS codes L8701 (Powered upper extremity range of motion assist 
device, elbow, wrist, hand with single or double upright(s), includes 
microprocessor, sensors, all components and accessories, custom 
fabricated) and L8702 (Powered upper extremity range of motion assist 
device, elbow, wrist, hand, finger, single or double upright(s), 
includes microprocessor, sensors, all components and accessories, 
custom fabricated)) were added to the HCPCS effective January 1, 2019 
to describe two categories of these items. These devices support the 
arm of the patient and allows them to use volitional, intact 
electromyographic signals in weak muscles to control the device through 
a normal range of motion. A lower extremity powered exoskeleton device 
that supports the weak legs of a patient with spinal cord injury (SCI) 
at levels T7 to L5 to enable the patient to perform ambulatory 
functions was also recently introduced to the market. Code K1007 
(Bilateral hip, knee, ankle, foot device, powered, includes pelvic 
component, single or double upright(s), knee joints any type, with or 
without ankle joints any type, includes all components and accessories, 
motors, microprocessors, sensors)) was added to the HCPCS effective 
January 1, 2020 to describe this category of items. The device uses 
motion sensors with an exoskeleton frame and onboard computer system. 
Patients using all of the devices, as previously described, are better 
able to elongate and flex their limbs using the respective device, 
sometimes in a braced manner and sometimes in a controlled manner of 
motion, thus improving the functioning of the malformed body member and 
supporting the weak limbs. Additional information on the items, as 
previously discussed, can be found at: www.cms.gov/files/document/2022-hcpcs-application-summary-biannual-1-2022-non-drug-and-non-biological-items-and-services.pdf.
    One additional issue related to leg braces with shoes that are an 
integral part of the brace. Section 1862(a)(8) of the Act generally 
excludes orthopedic shoes or other supportive devices for the feet from 
coverage under the Medicare program. However, longstanding policy at 
CMS Pub 100-02, Chapter 15, Sec.  290 of the Medicare Benefit Policy 
Manual indicates that this exclusion does not apply to such a shoe if 
it is an integral part of a leg brace, and if that shoe or other 
supportive device for the feet is an integral part of a leg brace, then 
the cost of that shoe or device is included as part of the cost of the 
brace. We are proposing to include this exception in the proposed 
definition of a brace at Sec.  410.2.
3. Proposed Regulation Changes
    We are proposing to amend the regulations at 42 CFR 410.2 to add 
the definition of brace to improve clarity and transparency regarding 
coverage and payment for the term brace as defined in section 
1861(s)(9) of the Act. Also, we believe adding the definition in 
regulations will improve the efficiency of the administration of the 
Medicare program when considering whether a new device is a leg, arm, 
back, or neck brace for benefit category and payment determinations 
under our review procedures at Sec.  414.240. In addition, we believe 
that adding the definition of a brace in regulation would expedite 
coverage and payment for newer technology and powered devices, 
potentially providing faster access to these new healthcare 
technologies for Medicare beneficiaries.
    We are proposing that the definition of brace at 42 CFR 410.2 would 
be consistent with CMS's longstanding brace policy and information at 
section 130 of chapter 15 of the Medicare Benefit Policy Manual (CMS 
Pub 100-02). Thus, we are proposing to specify in the definition that a 
brace is rigid or

[[Page 43780]]

semi-rigid and that the stiffness of the material used in making the 
device is essential to the definition of a brace for purposes of the 
scope of this Medicare benefit. Rigid refers to material used to 
eliminate motion but also to support underload. Components of a brace 
will use semi-rigid materials, which intentionally allow some amount of 
motion as compared to materials that completely immobilize. Also, we 
are proposing at 42 CFR 410.2 to specify in the definition that a brace 
is used for the purpose of supporting a weak or deformed body member or 
restricting or eliminating motion in a diseased or injured part of the 
body. In addition, we are proposing to specify at Sec.  
410.36(a)(3)(i)(A) that a brace may include a shoe if it is an integral 
part of a leg brace and its expense is included as part of the cost of 
the brace.
    We note three HCPCS codes were established to permit billing of the 
powered upper extremity devices and powered lower extremity exoskeleton 
devices. Two HCPCS codes were established effective October 1, 2019 
which are: L8701 (Powered upper extremity range of motion assist 
device, elbow, wrist, hand with single or double upright(s), includes 
microprocessor, sensors, all components and accessories, custom 
fabricated) and L8702 (Powered upper extremity range of motion assist 
device, elbow, wrist, hand, finger, single or double upright(s), 
includes microprocessor, sensors, all components and accessories, 
custom fabricated). One HCPCS was established effective October 1, 2020 
which is K1007 (Bilateral hip, knee, ankle, foot device, powered, 
includes pelvic component, single or double upright(s), knee joints any 
type, with or without ankle joints any type, includes all components 
and accessories, motors, microprocessors, sensors). However, 
corresponding Medicare benefit category and Medicare payment 
determinations were not finalized for these HCPCS codes to permit more 
time for evaluation. As a result of the proposal to amend the 
regulations at 42 CFR 410.2 to add the definition of brace, if 
finalized, these codes would be classified under the definition of 
brace. Using the processes outlined in regulations at 42 CFR 414.240, 
we intend to obtain public consultation on the payment determinations 
for these codes at an upcoming HCPCS Level II public meeting. 
Additional information on these HCPCS codes can be found in the HCPCS 
Level II Final Coding, Benefit Category and Payment Determinations 
First Biannual (B1), 2022 HCPCS Coding Cycle at www.cms.gov/files/document/2022-hcpcs-application-summary-biannual-1-2022-non-drug-and-non-biological-items-and-services.pdf. The agenda and dates for a 
public meeting will be available on the CMS HCPCS website: https://
www.cms.gov/Medicare/Coding/MedHCPCSGenInfo/HCPCSPublicMeetings.

D. Documentation Requirements for Durable Medical Equipment, 
Prosthetics, Orthotics, and Supplies Products Supplied as Refills to 
the Original Order

1. Background
    Durable medical equipment (DME) is covered as a benefit category 
under Part B under medical or other health services as described in 
section1861(s)(6) of the Act and defined under section 1861(n) of the 
Act. We further defined DME in regulations at Sec.  414.202 as 
equipment that can withstand repeated use, is primarily and customarily 
used to serve a medical purpose, is not generally useful to a person in 
the absence of an illness or injury, is appropriate for use in the 
home, and effective with respect to items classified as DME after 
January 1, 2012, has an expected life of at least 3 years. Certain 
items of DME require supplies for effective use. Supplies include, but 
are not limited to, drugs and biologicals that must be put directly 
into the equipment to achieve the therapeutic benefit or to assure the 
proper functioning of the equipment. Examples include oxygen, tumor 
chemotherapy agents transfused via an infusion pump, or diabetic test 
strips used with a home glucose monitor.
    Prosthetics and orthotics are defined under section 1861(s)(9) of 
the Act and include leg, arm, back, and neck braces and artificial 
legs, arms, and eyes--including replacements if required because of a 
change in the patient's physical condition. These items are referred to 
collectively as Durable Medical Equipment, Prosthetics, Orthotics, and 
Supplies (DMEPOS).
    DMEPOS items and supplies may be furnished on a recurring basis to 
beneficiaries with chronic or longer-term conditions. For such items, 
the practitioner may be able to forecast and prescribe, at the time of 
the beneficiary's initial need or during later clinical interaction, 
the ongoing medical need for DMEPOS items and/or supplies. In other 
words, the practitioner may be able to determine the beneficiary's 
expected, ongoing medical need both at the time of the interaction and 
as anticipated need for later dates of service. In such cases, the 
practitioner may write an order for immediate use and refills for later 
dates of service.
    Section 1893(a) of the Act authorized the Secretary to promote the 
program integrity of the Medicare program by entering into contracts 
with eligible entities to carry out activities specified in subsection 
(b) of such section. Section 1893(b)(1) of the Act, authorizes 
``[r]eview of activities of providers of services or other individuals 
and entities furnishing items and services for which payment may be 
made under this title . . . including medical and utilization review 
[emphasis added] . . .''. In response to concerns related to auto-
shipments and delivery of DMEPOS supplies that may no longer be needed 
or not needed at the same level of frequency/volume (for example, 
stockpiling), CMS instituted policies to require suppliers to contact 
the beneficiary prior to dispensing DMEPOS refills. In CY 2004, we 
updated our Medicare Program Integrity Manual to include timeframes 
related to refillable DMEPOS items.\186\ This was done to ensure that 
the refilled item was necessary and to confirm any changes/
modifications to the order. At that time, CMS stated that contact with 
the beneficiary or designee regarding refills should take place no 
sooner than 7 days prior to the delivery/shipping date. CMS further 
stated that subsequent deliveries of refills of DMEPOS products should 
occur no sooner than 5 days prior to the end of the usage for the 
current product. This change intended to allow for shipping of refills 
on ``approximately'' the 25th day of the month in the case of a month's 
supply, as later clarified and emphasized in preamble discussion in the 
CY 2005 Physician Fee Schedule final rule (69 FR 66235).
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    \186\ internet Only Manual 100-08, Program Integrity Manual 
(2004), available at: https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/downloads/R61PI.pdf.
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    In 2011, due to stakeholder concerns related to burden, we amended 
the Medicare Program Integrity Manual to state that contact with the 
beneficiary or designee regarding refills must take place no sooner 
than 14 calendar days prior to the delivery/shipping date, and that 
delivery of the DMEPOS product occur no sooner than 10 calendar days 
prior to the end of usage for the current product.\187\ This is the 
current policy on DMEPOS refills as described in the Medicare Program 
Integrity Manual.\188\
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    \187\ internet Only Manual 100-08, Program Integrity Manual 
(2011), available at: https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R378PI.pdf.
    \188\ internet Only Manual 100-08, Program Integrity Manual, 
Chapter 5, Section 5.2.6--Refills of DMEPOS Items Provided on a 
Recurring Basis (2022), available at: https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/pim83c05.pdf.

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[[Page 43781]]

    We note that while the timeframes are applicable to all refillable 
items, they are most pertinent to the mail/delivery model because those 
beneficiaries could potentially be most at risk for receiving 
unnecessary or unsolicited items and supplies. For beneficiaries 
calling, texting, or otherwise contacting their pharmacy or retail 
store and picking up their refills, we note the decreased potential for 
providing supplies that may not be medically necessary or for which the 
beneficiary has sufficient supply. For items that the beneficiary 
obtains in-person at a retail store, the signed delivery slip or a copy 
of the itemized sales receipt is sufficient documentation of a request 
for refill.
    Both delivery models are intended to allow for uninterrupted supply 
of the necessary item(s), and allow for the processing of claims for 
refills delivered/shipped prior to the beneficiary's complete 
exhaustion of their supply. We note that prior guidance related to this 
policy referred to this sort of permissible overlap as refills for 
items ``pending exhaustion''.
    Despite the long-standing programmatic safeguards, compliance with 
refill procedures continues to cause concerns. As recently as 2019, the 
HHS Office of Inspector General (HHS OIG) did a national study 
demonstrating that suppliers did not maintain sufficient refill 
documentation.\189\ In fact, one national DMEPOS supplier was recently 
revoked from the Medicare program due to billing for refills for 
beneficiaries that were deceased.\190\
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    \189\ Medicare Improperly Paid Suppliers an Estimated $92.5 
Million for Inhalation Drugs, (October 2019), https://oig.hhs.gov/oas/reports/region9/91803018.pdf.
    \190\ Press Release: Mail-Order Diabetic Testing Supplier and 
Parent Company Agree to Pay $160 Million to Resolve Alleged False 
Claims to Medicare (August 2, 2021), available at: https://www.justice.gov/opa/pr/mail-order-diabetic-testing-supplier-and-parent-company-agree-pay-160-million-resolve-alleged.
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    Due to ongoing compliance concerns, and in efforts to promote 
transparency, we propose to codify our refill documentation 
requirements. At the same time, we are continuing our efforts to reduce 
administrative burden. We have worked to identify many obsolete and 
burdensome regulations that could be eliminated or reformed to improve 
effectiveness. We have also examined our longstanding policies and 
practices that are not codified in regulations but could be changed or 
streamlined to achieve better outcomes and reduce provider and supplier 
burden. Additionally, we are requesting comment on whether there are 
ways to reduce burden for certain beneficiary populations for future 
rulemaking.
    Our refill policy has primarily been maintained in the Medicare 
Program Integrity Manual, Local Coverage Determinations, and related 
articles. We propose to codify and update our refill policy, in this 
proposed rule, to maintain program integrity controls while being 
mindful of supplier burden.
2. Provisions of the Proposed Regulations
a. Overview
    At this time, we believe it is appropriate to codify policies 
related to refills of DMEPOS items; taking into consideration the need 
to balance program integrity concerns (for example, stockpiling) 
against supplier burden concerns. While we continue to believe it 
appropriate to confirm the medical need for the refill prior to 
disbursement, we have found that minor deviations in timing are not 
always reflective of medical need. Therefore, we are proposing to 
strengthen our program integrity requirements to not only require 
beneficiary contact, but to specify that such contact must result in 
affirmative response from the beneficiary or designee. We propose to 
eliminate the 14-day timeframe, for beneficiary contact, and to rather 
rely upon a single 30-day timeframe for contact and confirmation of the 
need for refill. That is, beneficiary contact and confirmation of need 
for the refill must occur within the 30-day period prior to the end of 
the current supply. We propose to remove the term ``pending 
exhaustion'', which may be subject to interpretation, and instead use 
the phrase ``the expected end of the current supply.''
    We note that documentation of the need for refill, as obtained from 
the Medicare beneficiary or designee, is not expected to require 
specific quantities remaining--but rather to simply confirm their need 
for the next refillable item. Suppliers contacting the beneficiaries to 
confirm their need for the refill, shall confirm both that the 
beneficiary is using the item and requires the refill, as evidenced by 
the supplier documentation of an affirmative need for the refill. We 
believe this type of generalized affirmation, in conjunction with our 
claims processing controls, will provide sufficient program integrity 
controls.
    We believe the refill policy ensures that beneficiaries are 
participating in their health care to confirm they get the DMEPOS 
item(s) ordered and needed, which prevents individuals from receiving 
unnecessary supplies. It also protects the Trust Fund from the 
unnecessary provision of DMEPOS. We elongated the timeframe to 30-days 
and clarified that the beneficiary need not provide specific remaining 
quantities to comply. We believe this helps mitigate potential burden. 
However, we are seeking comment on if, due to beneficiary burdens, 
there are certain diagnosis/device combinations that a beneficiary 
should not need to confirm the need for a refill or confirm the need 
for refill with the same frequency. In other words, are there 
beneficiary populations for which we would not expect any fluctuations 
in the type or quantity of device, due to a permanent disability or 
health condition, for which the supplier verification of need would 
prove burdensome? Are there ways that Medicare could better balance the 
beneficiary burden of responding to supplier outreach (for example, 
text messaging, phone call to affirm need for recurring supply) when 
contrasted with the burden of receiving potentially unnecessary items 
(e.g., co-insurance payments)? We would take these comments into 
consideration for potential future policy changes to our DMEPOS refill 
policies.
    We propose to codify our longstanding requirement that delivery of 
DMEPOS items (that is, date of service) be no sooner than 10 calendar 
days before the expected end of the current supply. We note that the 
shipping timeframes have been relied upon for approximately 20 years--
to help both suppliers and Medicare Fee-for-Service contractors prevent 
overlapping billings and unnecessary refills. For example, contractors 
may use this timeframe to set up claims processing edits and alert 
suppliers when an item is being rendered/billed that was previously 
rendered and is not yet eligible for refill. We propose that date of 
service may be defined as either the date of delivery of the DMEPOS 
item, or for items rendered via delivery or shipping service, the 
supplier may use the shipping date as the date of delivery. We propose 
the shipping date may be defined as either the date the delivery/
shipping service label is created or the date the item is retrieved for 
shipment by the mail carrier/delivering party; however, such dates 
should not demonstrate significant variation.
b. Documentation To Support Refill
    We propose to revise Sec.  410.38, paragraph (d), by adding 
paragraph (d)(4) which outlines the documentation needed to support 
refill requirements. In paragraph (d)(4)(i), we define refills, date of 
service, and shipping date for purposes of this section. In paragraph 
(d)(4)(ii), we propose that

[[Page 43782]]

documentation must include the following:
     Evidence of the beneficiary or their representative's 
affirmative response of the need for supplies, which should be obtained 
as close to the expected end of the current supply as possible; Contact 
and affirmative response shall be within 30 calendar days from the 
expected end of the current supply.
     For shipped items, the beneficiary name, date of contact, 
the item requested, and an affirmative response from the beneficiary, 
indicative of the need for refill, prior to dispensing the product.
     For items obtained in-person from a retail store, the 
delivery slip signed by the beneficiary or their representative or a 
copy of the itemized sales receipt is sufficient documentation of a 
request for refill.
    In paragraph (d)(4)(iii), we propose the date of service for DMEPOS 
items provided on a recurring basis be no sooner than 10 calendar days 
prior to the expected end of the current supply.

VIII. Proposed Changes to the Provider and Supplier Enrollment 
Requirements

A. Background

1. Overview of Medicare Provider Enrollment
    Section 1866(j)(1)(A) of the Act requires the Secretary to 
establish a process for the enrollment of providers and suppliers into 
the Medicare program. The overarching purpose of the enrollment process 
is to help confirm that providers and suppliers seeking to bill 
Medicare for services and items furnished to Medicare beneficiaries 
meet all applicable federal and state requirements to do so. The 
process is, to an extent, a ``gatekeeper'' that prevents unqualified 
and potentially fraudulent individuals and entities from entering and 
inappropriately billing Medicare. Since 2006, we have undertaken 
rulemaking efforts to outline our enrollment procedures. These 
regulations are generally codified in 42 CFR part 424, subpart P 
(currently Sec. Sec.  424.500 through 424.575 and hereafter 
occasionally referenced as subpart P). They address, among other 
things, requirements that providers and suppliers must meet to obtain 
and maintain Medicare billing privileges.
    As outlined in Sec.  424.510, one such requirement is that the 
provider or supplier must complete, sign, and submit to its assigned 
Medicare Administrative Contractor (MAC) the appropriate enrollment 
form, typically the Form CMS-855 (OMB Control No. 0938-0685). 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, PECOS), collects important information about 
the provider or supplier. Such data includes, but is not limited to, 
general identifying information (for example, legal business name), 
licensure and/or certification data, and practice locations. The 
application is used for a variety of provider enrollment transactions, 
including the following:
     Initial enrollment--The provider or supplier is--(1) 
enrolling in Medicare for the first time; (2) enrolling in another 
Medicare contractor's jurisdiction; or (3) seeking to enroll in 
Medicare after having previously been enrolled.
     Change of ownership--The provider or supplier is reporting 
a change in its ownership.
     Revalidation--The provider or supplier is revalidating its 
Medicare enrollment information in accordance with Sec.  424.515. 
(Suppliers of durable medical equipment, prosthetics, orthotics, and 
supplies (DMEPOS) must revalidate their enrollment every 3 years); all 
other providers and suppliers must do so every 5 years.)
     Reactivation--The provider or supplier is seeking to 
reactivate its Medicare billing privileges after it was deactivated in 
accordance with Sec.  424.540.
     Change of information--The provider or supplier is 
reporting a change in its existing enrollment information in accordance 
with Sec.  424.516.
    After receiving the provider's or supplier's initial enrollment 
application, CMS or the MAC reviews and confirms the information 
thereon and determines whether the provider or supplier meets all 
applicable Medicare requirements. We believe this screening process has 
greatly assisted CMS in executing its responsibility to prevent 
Medicare fraud, waste, and abuse.
    As previously discussed, over the years we have issued various 
final rules pertaining to provider enrollment. These rules were 
intended not only to clarify or strengthen certain components of the 
enrollment process but also to enable us to take action against 
providers and suppliers: (1) engaging (or potentially engaging) in 
fraudulent or abusive behavior; (2) presenting a risk of harm to 
Medicare beneficiaries or the Medicare Trust Funds; or (3) that are 
otherwise unqualified to furnish Medicare services or items. Consistent 
with this, and as we discuss in section VIII.B. of this proposed rule, 
we propose several changes to our existing Medicare provider enrollment 
regulations.
2. Legal Authorities
    There are two principal categories of legal authorities for our 
proposed Medicare provider enrollment provisions:
     Section 1866(j) of the Act furnishes specific authority 
regarding the enrollment process for providers and suppliers.
     Sections 1102 and 1871 of the Act provide general 
authority for the Secretary to prescribe regulations for the efficient 
administration of the Medicare program.

B. Proposed Provisions

1. Provisional Period of Enhanced Oversight
    Section 1866(j)(3)(A) of the Act states that the Secretary shall 
establish procedures to provide for a provisional period of between 30 
days and 1 year during which new providers and suppliers--as the 
Secretary determines appropriate, including categories of providers or 
suppliers--would be subject to enhanced oversight. (Per section 
1866(j)(3)(A) of the Act, such oversight can include, but is not 
limited to, prepayment review and payment caps). As authorized by 
section 1866(j)(3)(B) of the Act, CMS previously implemented such 
procedures through sub-regulatory guidance with respect to newly 
enrolling HHAs' requests for anticipated payments (RAP). RAPs were 
upfront payments that HHAs received from Medicare before the beginning 
of a 30-day period of home health services. ``New'' HHAs were subject 
to a suppression of RAPs for a period between 30 days to 1 year (as 
determined by CMS) during the timeframe they were in the provisional 
period of enhanced oversight (PPEO). Each new HHA received notice of 
the length of time for which it was to be in the PPEO with RAP 
suppression. (CMS eliminated the use of RAPs for HHAs; beginning 
January 1, 2022, CMS replaced RAP submissions with a Notice of 
Admission.)
    During this prior PPEO, CMS received inquiries regarding the scope 
of the term ``new HHA'' as well as when the provisional period 
commenced. Although section 1866(j)(3)(B) of the Act states that we may 
implement procedures by program instruction, we believe in this 
particular instance (and based partly on our experience with the 
aforementioned HHA PPEO) that rulemaking is appropriate, though not 
statutorily required. This would help clarify: (1) what constitutes a 
``new''

[[Page 43783]]

provider or supplier for purposes of section 1866(j)(3) of the Act; and 
(2) when the PPEO begins. Such elucidation is important because we may, 
in the future, elect to apply our PPEO statutory authority to other 
categories of providers or suppliers per section 1866(j)(3)(A) of the 
Act. Accordingly, we propose the following provisions, both of which, 
we emphasize, would apply to PPEOs irrespective of the provider or 
supplier type involved.
    First, we propose in new Sec.  424.527(a) to define a ``new'' 
provider or supplier (exclusively for purposes of our PPEO authority 
under section 1866(j)(3) of the Act) as any of the following:
    ++ A newly enrolling Medicare provider or supplier. (This includes 
providers that must enroll as a new provider in accordance with the 
change in majority ownership provisions in Sec.  424.550(b).)
    ++ A certified provider or certified supplier undergoing a change 
of ownership consistent with the principles of 42 CFR 489.18. (This 
includes providers that qualify under Sec.  424.550(b)(2) for an 
exception from the change in majority ownership requirements in Sec.  
424.550(b)(1) but which are undergoing a change of ownership under 42 
CFR 489.18).
    ++ A provider or supplier (including an HHA or hospice) undergoing 
a 100 percent change of ownership via a change of information request 
under Sec.  424.516.
    We are including these transactions within our proposed definition 
because they have historically and generally involved the effective 
establishment of a new provider or supplier for purposes of Medicare 
enrollment. (To illustrate, CMS typically treats suppliers such as 
ambulance companies that are undergoing 100 percent ownership changes 
as new suppliers because of our uncertainty about the new owner's 
compliance with enrollment regulations, its billing behavior, etc.) 
Including such situations within proposed Sec.  424.527(a) is therefore 
necessary for CMS to exercise enhanced oversight, when warranted, of 
such entities. CMS would rely on the codified version of this policy 
once it becomes effective.
    Second, we propose in Sec.  424.527(b) that the effective date of 
the PPEO's commencement is the date on which the new provider or 
supplier submits its first claim (rather than, for example, the date 
the first service was performed or the effective date of the ownership 
change). There are two reasons for this proposal. One is that Sec.  
424.527(b) would align with our current practice as outlined in sub-
regulatory guidance. Also, we found during the previously-referenced 
HHA PPEO that certain affected HHAs refrained from billing after their 
placement in the PPEO to circumvent the enhanced oversight mechanism; 
then, once their PPEO lapsed, the HHA engaged in improper billing 
without the intended oversight. We believe Sec.  424.527(b) would help 
stem this practice via the PPEO's commencement upon the provider's or 
supplier's first claim submission. The provider or supplier would be 
unable to avoid the PPEO by delaying billing until the PPEO's 
expiration, as was the case with the HHA PPEO.
    Although we have elected to address the issues in proposed Sec.  
424.527 via rulemaking, we note that we retain the authority under 
section 1866(j)(3)(B) of the Act to establish and implement PPEO 
procedures via sub-regulatory guidance.
2. Retroactive Provider Agreement Terminations
    Under section 1866(a)(1) of the Act, all Medicare providers (as 
that term is defined in section 1866(e) of the Act) must enter into a 
provider agreement with the Secretary. Subparts A, B, and E of 42 CFR 
part 489 contain regulations concerning provider agreements. In 
accordance with Sec.  489.52, a provider may voluntarily terminate its 
provider agreement and thus depart the Medicare program. In doing so, 
and under existing sub-regulatory policy, the provider may request a 
retroactive termination effective date (for example, retroactive to the 
date the provider's facility closed). To incorporate this practice into 
regulation, we propose in new Sec.  489.52(b)(4) that a provider may 
request a retroactive termination date, but only if no Medicare 
beneficiary received services from the facility on or after the 
requested termination date. This latter caveat would financially 
protect beneficiaries by helping to ensure that Medicare may still 
cover the services furnished to them near the end of the provider's 
operations.
3. Hospice-Specific Provisions
a. Categorical Risk Screening
(1) Background
    Under the authority granted to us by section 6401(a) of the 
Affordable Care Act (which amended section 1866(j) to the Act), Sec.  
424.518 outlines levels of screening by which CMS and its MACs review 
initial applications, revalidation applications, applications to add a 
practice location, and applications to report any new owner. These 
screening categories and requirements are based on a CMS assessment of 
the level of risk of fraud, waste, and abuse posed by a particular type 
of provider or supplier. In general, the higher the level of risk a 
certain provider or supplier type poses, the greater the level of 
scrutiny with which CMS will screen and review providers or suppliers 
within that category.
    There are three levels of screening in Sec.  424.518: high, 
moderate, and limited. Irrespective of which level a provider or 
supplier type falls within, the MAC performs the following screening 
functions upon receipt of an initial enrollment application, a 
revalidation application, an application to add a new location, or an 
application to report a new owner:
     Verifies that the provider or supplier meets all 
applicable federal regulations and state requirements for their 
provider or supplier type.
     Conducts state license verifications.
     Conducts database checks on a pre- and post-enrollment 
basis to ensure that providers and suppliers continue to meet the 
enrollment criteria for their provider or supplier type.
    Providers and suppliers at the moderate and high categorical risk 
levels must also undergo a site visit. Furthermore, for those at the 
high screening level, the MAC performs two additional functions under 
Sec.  424.518(c)(2). First, the MAC requires the submission of a set of 
fingerprints for a national background check from all individuals who 
have a 5 percent or greater direct or indirect ownership interest in 
the provider or supplier. Second, it conducts a fingerprint-based 
criminal history record check of the Federal Bureau of Investigation's 
Integrated Automated Fingerprint Identification System on these 5 
percent or greater owners. These additional verification activities are 
meant to correspond to the heightened risk involved.
    There currently are only five provider and supplier types that fall 
within the high categorical risk level under Sec.  424.518(c)(1): 
newly/initially enrolling OTPs that have not been fully and 
continuously certified by SAMHSA since October 23, 2018 (hereafter 
collectively referenced as simply ``OTPs'' unless specified otherwise); 
newly/initially enrolling HHAs; newly/initially enrolling DMEPOS 
suppliers; newly/initially enrolling Medicare diabetes prevention 
program (MDPP) suppliers; and newly/initially enrolling skilled nursing 
facilities (SNFs). These five provider and supplier types are also 
subject to high-risk level screening if, as previously indicated, they 
are submitting a change of ownership

[[Page 43784]]

application under 42 CFR 489.18 or reporting any new owner (regardless 
of ownership percentage) in accordance with a change of information or 
other enrollment transaction under Title 42. They are subject to 
moderate level screening (rather than high) if they are revalidating 
their enrollment under Sec.  424.518.
(2) Categorical Risk Designation--Hospices
    Hospices are currently in the moderate-risk screening category 
under Sec.  424.518. However, CMS in recent years has become 
increasingly concerned about program integrity issues within the 
hospice community, particularly (though not exclusively) potential and 
actual criminal behavior, fraud schemes, and improper billing. There 
have been a number of criminal and False Claims Act cases involving 
hospice owners and overseers that have arisen since our initial 
designation of hospices as moderate risk in 2011. These include, but 
are by no means limited to, the following:
     In May 2014, a Pennsylvania hospice owner was sentenced to 
176 months in prison for organizing a scheme to defraud Medicare via 
his home hospice business. He had been found guilty of conspiracy to 
commit health care fraud, 21 counts of health care fraud, 11 counts of 
money laundering, and two counts of mail fraud. The owner's hospice had 
submitted to Medicare approximately $16.2 million in false claims for 
patients who were ineligible for hospice services and/or never received 
the level of hospice services for which the hospice billed. Other 
activities included the owner and co-owner: (1) directing staff to 
alter patient files and rewrite nursing documentation to make patients 
appear sicker than they actually were; and (2) paying doctors and other 
health care professionals for referring patients to the hospice even 
when the patients were neither eligible nor appropriate for hospice 
care.\191\
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    \191\ https://www.justice.gov/usao-edpa/pr/hospice-owner-sentenced-more-14-years-health-care-fraud-scheme.
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     In 2020, the owner and the chief executive officer (CEO) 
of a Texas-based group of hospices and HHAs were sentenced to 20 and 15 
years in prison, respectively. Both had falsely told thousands of 
patients with long-term incurable illnesses that they had under 6 
months left to live so as to enroll them in hospice programs for which 
they did not qualify.\192\ The OIG Dallas Region's special agent in 
charge stated that the owner's scheme, which involved over $150 million 
in false and fraudulent claims, included ``paying kickbacks to 
physicians and fraudulently enrolling vulnerable beneficiaries in 
hospice care that prevented them from accessing curative care--all done 
to steal millions of dollars from Medicare to fund lavish personal 
spending.'' \193\
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    \192\ https://www.justice.gov/opa/pr/ceo-sentenced-150-million-health-care-fraud-and-money-laundering-scheme; https://www.justice.gov/opa/pr/owner-texas-chain-hospice-companies-sentenced-150-million-health-care-fraud-and-money.
    \193\ https://www.justice.gov/opa/pr/owner-texas-chain-hospice-companies-sentenced-150-million-health-care-fraud-and-money.
---------------------------------------------------------------------------

     A California hospice administrator in February 2021 was 
sentenced to 30 months in prison for his part in a multimillion-dollar 
Medicare fraud scheme. The administrator and others paid illegal 
kickbacks to patient recruiters for referring beneficiaries to the 
hospice. When hospice staff informed the administrator that these 
referred individuals did not qualify for hospice care, the 
administrator overruled them and caused the beneficiaries to receive 
hospice services.\194\
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    \194\ https://www.justice.gov/opa/pr/hospice-administrator-sentenced-role-hospice-fraud-scheme.
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     In 2015, an Oklahoma hospice owner was convicted of 
Medicare fraud for submitting millions of dollars in fraudulent claims 
to Medicare. This included directing that certain medical documents be 
changed or written in a manner to: (1) give the appearance that nurses 
had visited patients or conducted assessments when they had not; and 
(2) make it appear that patients were sicker than they actually 
were.\195\
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    \195\ https://www.fbi.gov/news/stories/hospice-owner-falsified-numerous-claims.
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     A Georgia hospice owner in December 2021 pled guilty to 
one felony count of Medicaid fraud. State investigators found that the 
owner ``frequently took flights out of the country on dates that the 
defendant claimed she had personally provided hospice care here in 
Georgia.'' \196\
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    \196\ https://law.georgia.gov/press-releases/2021-12-22/carr-medicaid-fraud-control-unit-secures-guilty-plea-dekalb-county.
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     In August 2020, a New York hospice agreed to pay the 
United States $4,850,000 to resolve civil allegations that it billed 
Medicare and Medicaid for services furnished to hospice beneficiaries 
at heightened levels of care for which the patients did not 
qualify.\197\
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    \197\ https://www.justice.gov/usao-edny/pr/new-york-hospice-provider-settles-civil-healthcare-fraud-allegations.
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     A Florida hospice in July 2020 agreed to pay the United 
States $3.2 million to resolve allegations that it knowingly submitted 
false claims to Medicare, Medicaid, and TRICARE for hospice care 
furnished to patients who did not qualify for it. According to the 
Department of Justice, the hospice ``billed Medicare for four or more 
years of hospice care for certain patients who were not terminally ill 
for at least a portion of their greater than four-year hospice stay.'' 
\198\
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    \198\ https://www.justice.gov/usao-mdfl/pr/hope-hospice-agrees-pay-32-million-settle-false-claims-act-liability.
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     A multi-state hospice provider in December 2021 agreed to 
pay $5.5 million to the federal government to resolve allegations that 
it knowingly violated the False Claims Act by submitting claims to 
Medicare for hospice services furnished to beneficiaries who were not 
terminally ill.\199\
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    \199\ https://www.justice.gov/usao-wdtn/pr/crossroads-hospice-agrees-pay-55-million-settle-false-claims-act-liability.
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     In December 2018, a Pennsylvania hospice agreed to pay 
over $5.8 million to the federal government to resolve allegations that 
it violated the False Claims Act by submitting Medicare claims for 
hospice services that were medically unnecessary or lacked 
documentation.\200\
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    \200\ https://www.justice.gov/usao-edpa/pr/hospice-care-provider-pays-nearly-6-million-resolve-false-claims-act-allegations.
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     Another Pennsylvania hospice and its owner and CEO agreed 
in February 2018 to pay the United States $1.24 million to resolve 
allegations that the hospice: (1) fraudulently billed Medicare and 
Medicaid for hospice services furnished to beneficiaries who were not 
eligible for them; and (2) falsified records to support the false 
claims.\201\
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    \201\ https://www.justice.gov/usao-wdpa/pr/hospice-company-and-owner-agree-pay-124-million-settle-two-false-claims-act.
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     The founders of a Texas hospice and related HHA in January 
2021 paid over $1.8 million following an investigation into improper 
payments to physicians for referrals.\202\
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    \202\ https://www.justic.gov/usao-sdtx/pr/hospice-home-health-agency-and-owners-pay-over-18m-resolve-claims-concerning-physician.
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     A Florida-headquartered hospice in December 2021 agreed to 
pay the federal government over $5 million to resolve allegations that 
it knowingly billed Medicare and Medicaid for medically unnecessary and 
undocumented hospice services, including for at least 63 patients who 
had lengths of stays of more than 3 years. According to the government, 
for the 63 patients in question, the hospice either knowingly or 
recklessly did not document a

[[Page 43785]]

legitimate reason for the initial commencement of hospice care and/or 
subsequent hospice coverage. The government added that ``(m)any 
patients failed to demonstrate objective indications of decline 
throughout their time in the company's care, despite some being in 
hospice for nearly six years. Some patients had their hospice diagnoses 
changed after several years when they did not show decline under their 
original `terminal' diagnosis.'' \203\
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    \203\ https://www.justice.gov/usao-mdfl/pr/united-states-settles-false-claims-allegations-against-haven-hospice-more-5-million.
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     A Minnesota-based hospice in July 2016 agreed to pay $18 
million to resolve False Claims Act allegations that it billed Medicare 
for services for non-terminally ill patients. The federal government 
alleged that the hospice aimed to maximize the number of its Medicare 
patients ``without regard to whether the patients were eligible for and 
needed hospice. These business practices allegedly included 
discouraging doctors from recommending that ineligible patients be 
discharged from hospice.'' \204\
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    \204\ https://www.justice.gov/opa/pr/minnesota-based-hospice-provider-pay-18-million-alleged-false-claims-medicare-patients-who.
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     In February 2015, a multi-state hospice company agreed to 
pay $4 million to resolve allegations that it knowingly submitted or 
caused to be submitted false claims for hospice beneficiaries who were 
not terminally ill. The federal government contended that the company 
``engaged in certain business practices that contributed to claims 
being submitted for patients who did not have a terminal prognosis of 
six months or less by. . . paying bonuses to staff, including hospice 
marketers, admission nurses and executive directors, based on the 
number of patients enrolled.'' \205\ The government also alleged that 
the hospice ``hired medical directors based on their ability to refer 
patients, focusing particularly on medical directors with ties to 
nursing homes, which were seen as an easy source of patient 
referrals.'' \206\
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    \205\ https://www.justice.gov/opa/pr/united-states-settles-false-claims-act-suit-against-good-shepherd-hospice-inc-and-related.
    \206\ Ibid.
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     A Mississippi-based hospice chain in September 2015 agreed 
to pay the United States over $5.8 million to resolve False Claims Act 
allegations that it submitted false claims for continuous home care 
hospice services to beneficiaries who were not eligible to receive 
them.\207\
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    \207\ https://www.justice.gov/usao-sdms/pr/hospice-facility-and-its-managermajority-owner-pay-approximately-586-million-resolve.
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    One recent and especially disturbing case involved the sentencing 
in January 2022 of the CEO of a Texas hospice agency to over 13 years 
in prison after pleading guilty to conspiracy to commit Medicare and 
Medicaid fraud. The CEO admitted that he: (1) billed Medicare and 
Medicaid for hospice services that were not provided, not directed by a 
medical professional, or provided to patients who were ineligible for 
hospice care; and (2) used blank, pre-signed controlled substance 
prescriptions to prescribe potent drugs even though the CEO was not a 
medical professional.\208\ The CEO's scheme involved other individuals, 
thirteen of whom (including physicians) also pled guilty to crimes such 
as conspiracy to commit health care fraud.\209\ The acting United 
States Attorney for the case stated that the CEO ``scammed federal 
healthcare programs out of millions of dollars, and worse yet, denied 
vulnerable patients the medical oversight they deserved, writing pain 
prescriptions without physician input and allowing terminally ill 
patients to go unexamined.'' \210\ The Federal Bureau of Investigation 
special agent in charge added: ``In addition to causing fraudulent 
billing for tens of millions of dollars, [the CEO] preyed upon patients 
and families that did not have a true understanding of [the company] 
and hospice services. The core of the company was rooted in deception, 
and the lack of physician oversight allowed [the defendant] to make 
medical decisions for his own financial benefit.'' \211\
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    \208\ https://www.justice.gov/usao-ndtx/pr/novus-hospice-ceo-sentenced-13-years-healthcare-fraud.
    \209\ https://www.justice.gov/usao-ndtx/pr/13-novus-healthcare-
fraud-defendants-sentenced-combined-84-years-
prison#:~:text=Bradley%20Harris%2C%20Novus%20CEO%2C%20pleaded,Dr.
    \210\ https://www.justice.gov/usao-ndtx/pr/novus-hospice-ceo-pleads-guilty-healthcare-fraud.
    \211\ Ibid.
---------------------------------------------------------------------------

    The OIG, too, has noted the prevalence of hospice fraud schemes, 
issuing a July 2018 study titled ``Vulnerabilities in the Medicare 
Hospice Program Affect Quality Care and Program Integrity'' (OEI-02-16-
00570). According to this report, Medicare in 2016 spent about $16.7 
billion for hospice care for 1.4 million beneficiaries, an increase 
from $9.2 billion for less than 1 million beneficiaries in 2006; with 
this growth, the OIG stated that ``significant vulnerabilities'' have 
arisen, one of which involves improper activity.\212\ The report noted 
that some such schemes involved: (1) paying recruiters to target 
beneficiaries who were ineligible for hospice services; and (2) 
physicians falsely certifying beneficiaries as terminally ill when they 
were not. The OIG cited several of the cases discussed in this section 
VIII.B.3.a.(2) of this proposed rule as examples of this behavior.\213\
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    \212\ https://oig.hhs.gov/oei/reports/oei-02-16-00570.pdf, p. 1.
    \213\ Ibid.
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    Given all of the foregoing, we believe that certain provider 
enrollment measures are necessary to help address these issues. One of 
these measures involves closer screening of the owners of hospices. We 
previously cited criminal convictions of hospice owners and overseers. 
Although not every case of hospice fraud involves or can be 
attributable to the hospice's owner, we believe the owner can set the 
tone for the hospice's operations as a whole. If, accordingly, an owner 
has a criminal background involving fraud or patient abuse, this could 
lead to similar activity within the hospice. We believe that the 
increasing number of fraud cases warrants a revisiting of our original 
assignment of hospices to the moderate risk category. With our 
obligation to protect the Trust Funds and vulnerable Medicare 
beneficiaries, we believe more thorough scrutiny of hospice owners is 
required.
    To this end, we propose to revise Sec.  424.518 to move initially 
enrolling hospices and those submitting applications to report any new 
owner (as described in Sec.  424.518's opening paragraph) into the 
``high'' level of categorical screening; revalidating hospices would be 
subject to moderate risk-level screening. Requiring all hospice owners 
with 5 percent or greater direct or indirect ownership to submit 
fingerprints for a criminal background check would help us detect 
parties potentially posing a risk of fraud, waste, or abuse before it 
begins. Indeed, we have found our fingerprint-based criminal background 
checks to be of great assistance in detecting felonious behavior by the 
owners of high-risk providers and suppliers.
    We note that there is precedent for performing criminal background 
reviews on hospice personnel. Under the hospice conditions of 
participation at 42 CFR 418.114(d): (1) the hospice must obtain a 
criminal background check on all hospice employees who have direct 
patient contact or access to patient records; and (2) hospice contracts 
must require that all contracted entities obtain criminal background 
checks on contracted employees who have direct patient contact or 
access to patient records. Considering that hospice owners generally 
have oversight authority or

[[Page 43786]]

responsibility for all the hospice's operations, we believe it is 
important that the owner be subject to similar scrutiny.
    Initially enrolling hospices would be incorporated within revised 
paragraph (c)(1)(vi). The current language in paragraph (c)(1)(vi) 
would be included within new proposed paragraph (c)(1)(vii), to which 
would be added hospices disclosing a new owner.
b. 36-Month Rule
    The general purpose of a state survey or accreditation review for 
any Medicare provider or supplier type subject thereto is to determine 
whether the provider or supplier is in compliance with its regulatorily 
prescribed conditions of participation or conditions of coverage 
(hereafter collectively referenced as CoPs). CoPs are federal 
requirements that a provider or supplier must meet to participate in 
the Medicare program, and they generally focus on health and safety 
protections. Although they can vary by provider and supplier type, they 
address matters such as, but not limited to, the following:

 Personnel qualifications
 Infection prevention and control
 Emergency preparedness
 Staffing ratios
 Patient safety
 Patients' bill of rights
 Licensure
 Fire prevention
 Adherence to federal, state, and local requirements

    CoPs are critical to ensuring that providers and suppliers are 
legitimate, bona fide entities capable of furnishing quality care and 
following safety requirements.
    Though it is a provider enrollment provision, Sec.  424.550(b)(1) 
recognizes the importance of the HHA survey and accreditation processes 
(hereafter sometimes collectively referenced as the ``survey 
process''), which help confirm the HHA's compliance with the CoPs and 
the quality and safety requirements they entail. Section 424.550(b)(1) 
states if an HHA undergoes a change in majority ownership (occasionally 
referenced as a ``CIMO'') by sale within 36 months after the effective 
date of the HHA's initial enrollment in Medicare or within 36 months 
after the HHA's most recent CIMO, the provider agreement and Medicare 
billing privileges do not convey to the HHA's new owner. The 
prospective provider/owner of the HHA must instead: (1) enroll in 
Medicare as a new (initial) HHA; and (2) obtain a state survey or an 
accreditation from an approved accreditation organization. As defined 
in 42 CFR 424.502, a ``change in majority ownership'' occurs when an 
individual or organization acquires more than a 50 percent direct 
ownership interest in an HHA during the 36 months following the HHA's 
initial enrollment or most recent CIMO; this includes an acquisition of 
majority ownership through the cumulative effect of asset sales, stock 
transfers, consolidations, or mergers. Under Sec.  424.550(b)(1), a 42 
CFR 489.18-level change of ownership and/or 100 percent ownership 
transfer is not necessary to trigger this ``36-month rule.'' Only 
crossing the 50 percent ownership threshold is required.
    Section 424.550(b)(1) was promulgated in 2009 and modified in 2010. 
There were two principal objectives behind its establishment.
    First, there was a trend in the HHA community whereby an HHA 
applied for Medicare certification, underwent a survey, and became 
enrolled in Medicare, but then immediately sold the HHA without having 
seen a Medicare beneficiary or hired an employee. These brokers, in 
other words, enrolled in Medicare exclusively to sell the HHA rather 
than to provide services to beneficiaries. This practice enabled a 
purchaser of an HHA from the broker to enter Medicare with no survey, 
which, in turn, sometimes led that owner to soon sell the business to 
another party. The ``flipping'' or ``turn-key'' mechanism, in short, 
was used to circumvent the survey process.
    Second, we were more broadly concerned about the lack of scrutiny 
of new owners as a whole, not merely in cases of flipping. We made 
clear in the CY 2010 HH PPS final rule (74 FR 58078), in which we 
promulgated Sec.  424.550(b)(1), that the intent of Sec.  424.550(b)(1) 
goes beyond the issue of ''turn-key'' operations.\214\ We explained 
that if an HHA undergoes a change of ownership, CMS--at the current 
time--generally does not perform a survey pursuant thereto. 
Consequently, CMS has no sure way of knowing whether the HHA, under its 
new ownership and management, is in compliance with the HHA CoPs. 
Unless CMS can make this determination, there is a risk that the newly-
purchased HHA, without having been appropriately vetted, will bill for 
services when it is out of compliance with the CoPs.\215\ We added that 
in light of a GAO report we cited in the CY 2010 HH PPS proposed rule 
that outlined problematic activities involving HHAs, we believed it was 
imperative that we ensure that a newly-purchased HHA be subjected to an 
appropriate level of review.\216\
---------------------------------------------------------------------------

    \214\ 74 FR 58118.
    \215\ Ibid.
    \216\ 74 FR 58118-58119; ``Improvements Needed to Address 
Improper Payments in Home Health'' (GAO-09-185).
---------------------------------------------------------------------------

    We previously outlined in this section VIII.B.3.a.(2). of this 
proposed rule our growing concerns about improper behavior within the 
hospice community. Yet, we are equally concerned about the quality of 
care furnished in some of these facilities. Indeed, we have seen an 
increase in the number of hospice changes of ownership (including the 
types of CIMOs described in 42 CFR 424.550(b)(1)) in recent years, and 
a number of these ownership changes have occurred within the applicable 
36-month timeframe. In fact, some such changes have taken place within 
only a few months after enrollment or the previous CIMO, akin to what 
we saw with the ``flipping'' practice outlined in the CY 2010 HH PPS 
proposed and final rules; specifically, we have received reports that 
hospices are being sold quickly after enrollment or purchase so that 
the new owner can avoid any survey. This is because, as had been our 
concern with HHAs, hospice ownership changes generally do not result in 
a state survey or accreditation review.
    Aside from the July 2018 OIG report referenced earlier, which, as 
noted by its title, stated that vulnerabilities in the Medicare hospice 
program impact quality care, the Government Accountability Office (GAO) 
in October 2019 issued a report titled, ``Medicare Hospice Care: 
Opportunities Exist to Strengthen CMS Oversight of Hospice Providers'' 
(GAO-20-10).\217\ The GAO observed therein that the number of: (1) 
Medicare hospice beneficiaries had almost tripled from 2000 to nearly 
1.5 million by 2017; and (2) Medicare hospice providers had 
doubled.\218\ The GAO stated that in light of this growth: ``It is 
imperative that CMS's oversight of the quality of Medicare hospice care 
keeps pace with changes so that the agency can ensure the health and 
safety of these terminally ill beneficiaries.'' \219\
---------------------------------------------------------------------------

    \217\ https://www.gao.gov/assets/gao-20-10.pdf.
    \218\ Ibid., p. 25.
    \219\ Ibid.
---------------------------------------------------------------------------

    In sum, hundreds of hospice ownership changes have occurred since 
2018 for which CMS may not know whether the facility under its new 
ownership and leadership is compliant with the hospice CoPs. This is a 
significant vulnerability. Many millions of dollars could be improperly 
paid to newly purchased hospices that are not adhering to Medicare 
requirements. More crucially, it is unknown whether

[[Page 43787]]

newly purchased hospices are furnishing quality care to the facility's 
beneficiaries, which, if they are not, can put patients' lives in 
danger; we previously saw in this section VIII.B.3.a.(2). of this 
proposed rule the great risks associated with uncommitted ownership. We 
believe that a comprehensive survey would be the most effective means 
of confirming that newly purchased hospices are meeting the CoPs and 
are positioned to provide quality care and protect beneficiaries.
    Consequently, we are proposing to expand the scope of Sec.  
424.550(b)(1) to include hospice CIMOs within its purview. (The 
aforementioned definition of ``change in majority ownership'' in Sec.  
424.502 would also be expanded to incorporate hospices therein.) We 
believe that our previously detailed concerns about hospices, such as 
fraud schemes, patient abuse, and improper billing, require the level 
of scrutiny that a survey can furnish. Although surveys cannot by 
themselves entirely halt all of these issues, we are confident that a 
survey's thoroughness can greatly assist the vetting of the new owner 
to help ensure the latter's commitment to quality care.
    We note that Sec.  424.550(b)(2) contains several exceptions to the 
36-month rule. Specifically, even if an HHA undergoes a CIMO, the 
requirement in Sec.  424.550(b)(1) that the HHA enroll as a new HHA and 
undergo a survey or accreditation does not apply if any of the 
following four exceptions are implicated:
     The HHA submitted 2 consecutive years of full cost reports 
since initial enrollment or the last CIMO, whichever is later.
     An HHA's parent company is undergoing an internal 
corporate restructuring, such as a merger or consolidation.
     The owners of an existing HHA are changing the HHA's 
existing business structure (for example, from a corporation to a 
partnership (general or limited)), and the owners remain the same.
     An individual owner of an HHA dies.
    These exceptions were added to Sec.  424.550(b) in a final rule 
published in the Federal Register on November 17, 2010 titled, 
``Medicare Program; Home Health Prospective Payment System Rate Update 
for Calendar Year 2011; Changes in Certification Requirements for Home 
Health Agencies and Hospices'' (75 FR 70372). We promulgated them 
because the HHA community had expressed concerns that the 36-month rule 
could inhibit bona fide HHA ownership transactions; for example, 
prospective new owners may not wish to have to enroll as a new HHA and 
will therefore decline to purchase the entity. We believed that our 
exceptions struck a solid balance between the need for more scrutiny of 
new owners via the survey process while not inadvertently obstructing 
legitimate transactions involving legitimate parties. As an 
illustration, a CIMO resulting from an internal restructuring can 
frequently pose less of a risk of ``flipping'' than an HHA that--2 
months after initial enrollment--is sold to another party strictly to 
circumvent the survey process. These exceptions, in our view, still 
soundly balance the two aforementioned considerations, and we therefore 
are not proposing to exempt hospices from them.
c. Additional Hospice Ownership Matters
    CMS is taking additional provider enrollment steps to address 
(either wholly or in part) hospice ownership and program integrity. To 
illustrate, we proposed in a December 15, 2022 Paperwork Reduction Act 
submission (87 FR 76626) to revise the Form CMS-855A Medicare provider 
enrollment application (Medicare Enrollment Application--Institutional 
Providers; OMB Control No. 0938-0685) to collect from providers/
suppliers (including hospices) that complete this form important data 
such as, but not limited to:
     Requiring the provider/supplier/hospice to specifically 
identify via a checkbox whether a reported organizational owner is 
itself owned by another organization or individual.
     Requiring the provider/supplier/hospice to explicitly 
identify whether a listed organizational owner/manager does or does not 
fall within the categories of entities listed on the application (for 
example, holding company, investment firm, etc.), with ``private-equity 
company'' and ``real estate investment trust'' being added to this list 
of organization types.
    This information will assist CMS in better understanding the 
provider/supplier/hospice's indirect ownership relationships and the 
types of entities that own it.
    In addition, in a proposed rule published in the Federal Register 
on April 4, 2023 titled ``Medicare Program; FY 2024 Hospice Wage Index 
and Payment Rate Update, Hospice Conditions of Participation Updates, 
Hospice Quality Reporting Program Requirements, and Hospice Certifying 
Physician Provider Enrollment Requirements'' (88 FR 20022), we proposed 
to require physicians who order or certify hospice services for 
Medicare beneficiaries to be enrolled in or validly opted-out of 
Medicare as a prerequisite for the payment of the hospice service in 
question. We stated therein our belief that the careful screening the 
enrollment process entails would help us determine whether the 
physician meets all federal and state requirements (such as licensure) 
or presents any program integrity risks (for example, final adverse 
actions).
    Our aforementioned hospice high-risk screening and 36-month rule 
proposals represent further steps towards addressing hospice ownership 
and payment safeguard issues, and we are considering additional 
measures regarding these topics.
4. Deactivation for 12-Months of Non-Billing
    Regulatory policies regarding the provider enrollment concept of 
deactivation are addressed in Sec.  424.540. Deactivation means that 
the provider's or supplier's billing privileges are stopped but can be 
restored (or ``reactivated'') upon the submission of information 
required under Sec.  424.540. A deactivated provider or supplier is not 
revoked from Medicare and remains enrolled. Also, per Sec.  424.540(c), 
deactivation does not impact the provider's or supplier's existing 
provider or supplier agreement; the deactivated provider or supplier 
may also file a rebuttal to the action in accordance with Sec.  
424.546. Nonetheless, the provider's or supplier's ability to bill 
Medicare is halted pending its compliance with Sec.  424.540's 
requirements for reactivation.
    To reactivate its billing privileges, the affected provider or 
supplier per Sec.  424.540(b) must recertify that its current 
enrollment information on file with Medicare is correct, furnish any 
missing information as appropriate, and be in compliance with all 
applicable enrollment requirements in Title 42. CMS reserves the right, 
though, to require the submission of a complete Form CMS-855 
application prior to any reactivation. The reactivation process is 
designed to confirm that the deactivated provider or supplier is 
adherent to all applicable Title 42 provider enrollment provisions.
    There are currently eight reasons under Sec.  424.540(a) for which 
CMS can deactivate a provider or supplier, one of which is that the 
provider or supplier has not submitted any Medicare claims for 12 
consecutive months. (The 12-month period begins the first day of the 
first month without a claims submission through the last day of the 
12th month

[[Page 43788]]

without a submitted claim.) This particular deactivation ground was 
established via a final rule published in the Federal Register on April 
21, 2006 titled ``Medicare Program; Requirements for Providers and 
Suppliers to Establish and Maintain Medicare Enrollment'' (71 FR 
20754). In the April 25, 2003 proposed rule associated with this final 
rule, we proposed to have the authority to deactivate a provider or 
supplier after 6 months of Medicare non-billing.\220\ Although, at the 
time per subregulatory guidance, our policy was to permit deactivation 
after 12 months, we proposed 6 months due to several program integrity 
issues related to inactive billing numbers. We outlined in that 
proposed rule our desire to prevent, for instance: (1) questionable 
businesses from deliberately obtaining multiple numbers so they could 
keep one `in reserve' [for future use] if their active billing number 
is subject to a payment suspension; and (2) fraudulent entities from 
obtaining information about discontinued providers or suppliers and 
then, for example, using the Medicare billing number of a deceased 
physician.\221\
---------------------------------------------------------------------------

    \220\ Medicare Program; Requirements for Establishing and 
Maintaining Medicare Billing Privileges (68 FR 22064).
    \221\ Ibid. (68 FR 22072).
---------------------------------------------------------------------------

    Based on feedback from commenters, we did not finalize our proposed 
reduction to 6 months in the April 21, 2006 final rule. Yet we remained 
concerned about situations where a provider or supplier does not bill 
for 6 months, as this could indicate, for instance, that the provider 
or supplier is no longer operational and that its billing number thus 
could be accessed by another party intent on improper billing. More 
importantly, we have recently detected fraud schemes involving extended 
periods of non-billing. A common situation involves a provider that: 
(1) establishes multiple enrollments with multiple billing numbers; (2) 
abusively or inappropriately bills under one billing number; (3) 
receives an overpayment demand letter or becomes the subject of 
investigation; (4) voluntary terminates the billing number in question; 
and then (5) begins to bill via another of its billing numbers that is 
dormant (for example, 6 consecutive months without billing) but 
nonetheless active, repeating the same improper conduct as before. The 
problem in this case is that we cannot deactivate the dormant billing 
number (hence rendering it unusable and inaccessible pending a 
reactivation) under Sec.  424.540(a)(1) because the applicable 12-month 
period has not yet expired.
    This type of ``whack-a-mole'' activity is similar to that which we 
cited previously in the April 25, 2003 proposed rule as justification 
for the proposed 6-month deactivation threshold therein. The 
difference, though, is that these fraud schemes have become 
increasingly prevalent in recent years such that we must revisit the 
current 12-month timeframe in Sec.  424.540(a)(1). We do not believe we 
can or should wait for a year to elapse before taking deactivation 
action against these providers and suppliers. To protect the Trust 
Funds against improper payments, we must be able to move more promptly 
to deactivate these ``spare'' billing numbers so the latter cannot be 
inappropriately used or accessed.
    However, we emphasize that our concerns are not limited to the 
aforementioned scenarios regarding fraudulent activity. A lack of 
billing for an extended period can, as previously discussed, indicate 
that the provider or supplier has ceased operations without notifying 
CMS. Deactivating the number enables CMS to not only prevent it from 
being accessed by other parties but also confirm via the deactivation 
process whether the provider or supplier is in fact operational--
specifically, whether the provider or supplier responds with a 
reactivation application. In other words, action under Sec.  
424.540(a)(1) helps protect the Medicare program by deactivating the 
number while verifying whether the provider or supplier remains in 
existence; if it does, and it subsequently submits a reactivation 
application, CMS can validate the data thereon to ensure the provider's 
or supplier's continued credentials and compliance with Medicare 
requirements. This protective process, we believe, should be available 
to us upon the expiration of a 6-month non-billing period, for our 
earlier-referenced concerns exist whenever any extensive timeframe of 
non-billing occurs. The sooner we can address these non-billing cases, 
the better we can protect the Trust Funds. For these reasons, we 
propose to revise Sec.  424.540(a)(1) to change the 12-month time 
therein to 6 months.
    We certainly recognize that there are lengthy periods of non-
billing that do not involve any improper activity. To illustrate, we 
know that some providers are required to be enrolled in Medicare in 
order to enroll in another health care program; as the provider does 
not intend to bill Medicare but only the other program, an extended 
period of Medicare non-billing can result. While CMS retains the 
discretion, as it always has, to deactivate a provider or supplier if 
the contingency in Sec.  424.540(a)(1) is triggered, providers and 
suppliers that are not typically deactivated for 12 months of non-
billing should not assume they would be more likely to be so 
deactivated under our proposed change to 6 months.
5. Definition of ``Managing Employee''
    Consistent with sections 1124 and 1124A of the Act, providers and 
suppliers are required to report their managing employees via the 
applicable Medicare enrollment application in order to enroll in 
Medicare. We currently define a ``managing employee'' in Sec.  424.502 
as a ``general manager, business manager, administrator, director, or 
other individual that exercises operational or managerial control over, 
or who directly or indirectly conducts, the day-to-day operation of the 
provider or supplier (either under contract or through some other 
arrangement), whether or not the individual is a W-2 employee of the 
provider or supplier.'' In a proposed rule published in the Federal 
Register on February 15, 2023 titled ``Medicare and Medicaid Programs; 
Disclosures of Ownership and Additional Disclosable Parties Information 
for Skilled Nursing Facilities and Nursing Facilities'' (88 FR 9820), 
we proposed to revise this definition under our proposed implementation 
via that rule of section 1124(c) of the Act. We specifically proposed 
that, for purposes of 42 CFR 424.516(g) and with respect to a SNF, a 
managing employee also includes a general manager, business manager, 
administrator, director, or consultant, who directly or indirectly 
manages, advises, or supervises any element of the practices, finances, 
or operations of the facility. As proposed, this SNF-exclusive 
definition would be in a new paragraph (2) of the managing employee 
definition in Sec.  424.502; the existing version of the definition 
would be included within new paragraph (1).
    We are proposing to further revise this definition in the present 
proposed rule. We have received questions from the hospice and SNF 
communities regarding whether hospice and SNF facility administrators 
and medical directors must be disclosed as managing employees on the 
enrollment application. It has been our experience in overseeing the 
Medicare provider enrollment process that such individuals indeed 
exercise managing control over the hospice or SNF, and we have long 
required that they be reported as managing employees.

[[Page 43789]]

    Accordingly, we propose to further revise the managing employee 
definition in Sec.  424.502 by adding the following language 
immediately after (and in the same paragraph as) the current 
definition: For purposes of this definition, this includes, but is not 
limited to, a hospice or skilled nursing facility administrator and a 
hospice or skilled nursing facility medical director. This change would 
be reflected in the first paragraph of the revised definition of this 
term as proposed in the February 15, 2023 proposed rule. That is, the 
revision described in this section VIII.(B)(5) would be added to the 
end of new paragraph (1) as the latter was proposed in the February 15, 
2023 proposed rule.
    We stress that this clarification regarding hospice and SNF 
facility administrators and medical directors should in no manner be 
construed as CMS' establishment of a minimum threshold for reporting 
managing employees of hospices, SNFs, or any other provider or supplier 
type. Put otherwise, simply because an individual has less managing 
control within a particular organization than a facility administrator 
or medical director does not mean that the person need not be 
disclosed. Any individual who meets the definition of managing employee 
in Sec.  424.502 must be reported irrespective of the precise amount of 
managing control the person has. The exclusive purpose of our proposed 
elucidation is to address specific questions raised by hospices and 
SNFs concerning whether the individuals at issue must be reported. It 
is not meant to change existing reporting requirements regarding 
managing employees and who must be disclosed as such.
6. Previously Waived Fingerprinting of High-Risk Providers and 
Suppliers
    During the recent COVID-19 public health emergency (PHE), CMS 
temporarily waived the requirement for fingerprint-based criminal 
background checks (FBCBCs) for 5 percent or greater owners of newly 
enrolling providers and suppliers falling within the high-risk 
screening category in Sec.  424.518(c). The principal purpose was to 
facilitate beneficiary access to services by potentially increasing the 
number of health care providers and suppliers. Given the scope of the 
emergency, we believed this had to take priority. To reduce the program 
integrity risks of this waiver, we continuously monitored criminal 
alerts produced via our internal screening mechanism. Nevertheless, we 
remained concerned during the waiver period about the lack of FBCBCs 
being performed. Although the criminal alerts were useful, we have 
found FBCBCs to be the best and surest means of detecting felonious 
behavior by the owners of high-risk providers and suppliers.
    With this in mind, we wish to perform FBCBCs for high-risk 
providers and suppliers that initially enrolled during the PHE upon 
their revalidation once the PHE ends. Yet this is not possible under 
our existing regulations because the revalidation applications would 
only be screened at the moderate-risk level. To remedy this, we propose 
to add new Sec.  424.518(c)(1)(viii) that would incorporate within the 
high-screening category revalidating DMEPOS suppliers, HHAs, OTPs, 
MDPPs, and SNFs for which CMS waived the FBCBC requirement when they 
initially enrolled in Medicare. However, given the potential for future 
emergencies for which CMS might waive FBCBCs under applicable legal 
authority (such as that for the PHE), we more specifically propose in 
new Sec.  424.518(c)(1)(viii) that this high-risk category (which would 
include hospices with respect to future waivers) would apply to 
situations where CMS waived FBCBCs, in accordance with applicable legal 
authority, due to a national, state, or local emergency declared under 
existing law. We emphasize that our proposal does not obligate CMS to 
waive the FBCBC requirement in any such emergency. Any decision to do 
so rests with CMS, and such waivers would, if they occur at all in the 
future, would be reserved for the most exceptional of circumstances.
    Along with adding new Sec.  424.518(c)(1)(viii), we propose to 
delete current Sec.  424.518(b)(1)(iv), (ix), (x), (xi), (xiii), and 
(xiv), which individually identify the six previously discussed 
provider and supplier types (including hospices) as moderate-risk if 
they are revalidating their enrollment. We would redesignate existing 
paragraphs (b)(1)(v) through (b)(1)(viii) as revised paragraphs 
(b)(1)(iv) through (b)(1)(vii). We would also redesignate existing 
paragraph (b)(1)(xii) as revised (b)(1)(viii), with the former 
paragraph being deleted. Revised paragraph (b)(1)(viii) would include 
both prospective and revalidating OTPs that have been fully and 
continuously certified by SAMHSA since October 23, 2018. Furthermore, 
we would establish a revised paragraph (b)(1)(ix) that would include 
within the moderate-risk category revalidating DMEPOS suppliers, HHAs, 
OTPs, MDPPs, SNFs, and hospices that underwent FBCBCs: (1) when they 
initially enrolled in Medicare; or (2) upon revalidation after CMS 
waived the FBCBC requirement (under the circumstances described in 
paragraph (c)(1)(viii)) when the provider or supplier initially 
enrolled in Medicare. This second provision is to clarify that the 
providers and suppliers referenced in paragraph (c)(1)(viii) do not 
remain in the high-screening category in perpetuity solely because they 
were not fingerprinted upon initial enrollment. Once the provider or 
supplier is fingerprinted upon revalidation, it would move to the 
moderate-risk category unless another basis exists under paragraph (c) 
for retaining it within the high-risk category.
    As indicated previously, DMEPOS suppliers are required to 
revalidate their Medicare enrollment every 3 years; HHAs, OTPs, MDPPs, 
SNFs, and hospices must do so every 5 years. We note, though, that CMS 
under Sec.  424.515(d) can perform off-cycle revalidations; that is, we 
can revalidate a provider or supplier at any time and need not wait 
until the arrival of their 5-year (or, for DMEPOS suppliers, 3-year) 
revalidation cycle. Should this proposed rule be finalized, CMS would 
accordingly reserve the right to conduct off-cycle revalidations of the 
previously discussed FBCBC-waived high-risk providers and suppliers.
7. Expansion of Reapplication Bar
    Section 424.530(f) permits CMS to prohibit a prospective provider 
or supplier from enrolling in Medicare for up to 3 years if its 
enrollment application is denied because the provider or supplier 
submitted false or misleading information on or with (or omitted 
information from) its application in order to enroll. The purpose of 
Sec.  424.530(f) is to prevent dishonest providers and suppliers from 
submitting false information on their initial application and, after 
being denied enrollment on this ground under Sec.  424.530(a)(4), 
simply submitting a new application with correct data.
    The existing maximum length of a reapplication bar under Sec.  
424.530(f) is 3 years. We propose to expand this to 10 years to account 
for provider or supplier conduct of particular severity. We must be 
able to prevent such problematic parties from repeatedly submitting 
applications over many years with the goal of somehow getting into the 
program. We note that there is precedent for this 10-year period. 
Section 424.530(a)(3)(ii) states that a denial based on a felony 
conviction is for a period not less than 10 years from the date of 
conviction if the individual has been convicted on one previous 
occasion of one or more offenses. Too, reenrollment bars under

[[Page 43790]]

Sec.  424.535(c)(1)(i) are for a maximum 10-year timeframe. Although 
reenrollment bars are different from reapplication bars in terms of how 
and when they are applied, the aim of both is to protect Medicare and 
its beneficiaries. We believe it is largely immaterial from a program 
integrity standpoint whether a denial or revocation and subsequent bar 
stemming from the submission of false or misleading data involved a 
prospective or an enrolled provider, for the underlying conduct in 
either case is the same.
8. Ordering, Referring, Certifying, and Prescribing Restrictions
    We discussed previously: (1) the need to increase the maximum 
reapplication bar to keep dishonest providers and suppliers out of 
Medicare for longer than 3 years; and (2) our concerns about felonious 
provider and supplier activity. We believe such provider and supplier 
behavior should result in restrictions regarding the ordering, 
referring, certifying, or prescribing of Medicare services, items, and 
drugs, too. Indeed, such ordering, referring, certifying, or 
prescribing can involve improper conduct that is as harmful to Medicare 
beneficiaries as the actual furnishing of services; this includes, for 
example, the over-prescribing of opioids and the unnecessary ordering 
of potentially dangerous tests. Consequently, and using our general 
rulemaking authority under sections 1102 and 1871 of the Act, we 
propose the following two provisions.
    First, we propose to add a new paragraph (3) to Sec.  424.530(f) 
stating that a provider or supplier that is currently subject to a 
reapplication bar under paragraph (f) may not order, refer, certify, or 
prescribe Medicare-covered services, items, or drugs. To enforce this 
policy, we would further state in proposed Sec.  424.530(f)(3) that 
Medicare does not pay for any otherwise covered service, item, or drug 
that is ordered, referred, certified, or prescribed by a provider or 
supplier that is currently under a reapplication bar.
    Second, we propose in paragraph (a) of new Sec.  424.542 that a 
physician or other eligible professional (regardless of whether he or 
she is or was enrolled in Medicare) who has had a felony conviction 
within the previous 10 years that CMS determines is detrimental to the 
best interests of the Medicare program and its beneficiaries may not 
order, refer, certify, or prescribe Medicare-covered services, items, 
or drugs. Akin to proposed Sec.  424.530(f)(3), we would state in Sec.  
424.542(b) that Medicare does not pay for any otherwise covered 
service, item, or drug that is ordered, referred, certified, or 
prescribed by a physician or other eligible professional (as that term 
is defined in section 1848(k)(3)(B) of the Act) who has had a felony 
conviction within the previous 10 years that CMS determines is 
detrimental to the best interests of the Medicare program and its 
beneficiaries.
    These provisions would apply regardless of whether the provider or 
supplier has opted-out of Medicare. This is because the conduct 
associated with a reapplication bar and a felony conviction presents a 
risk irrespective of the provider's or supplier's opt-out status.

IX. Collection of Information Requirements

A. Statutory Requirement for Solicitation of Comments

    Under the Paperwork Reduction Act of 1995, we are required to 
provide a 60-day notice in the Federal Register and solicit public 
comment before a collection of information requirement is submitted to 
the Office of Management and Budget (OMB) for review and approval. In 
order to fairly evaluate whether an information collection should be 
approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act 
of 1995 requires that we solicit comment on the following issues:
     The need for the information collection and its usefulness 
in carrying out the proper functions of our agency.
     The accuracy of our estimate of the information collection 
burden.
     The quality, utility, and clarity of the information to be 
collected.
     Recommendations to minimize the information collection 
burden on the affected public, including automated collection 
techniques.

B. Information Collection Requirements (ICRs)

    In the CY 2023 HH PPS rule, we solicited public comment on each of 
these issues for the following sections of this document that contain 
information collection requirements (ICRs).
1. ICRs for HH QRP
    As discussed in section III. of this proposed rule, we propose that 
HHAs would collect data on one new quality measure, the Discharge 
Function Score (DC Function) measure, beginning with assessments 
completed on January 1, 2024. However, the DC Function measure utilizes 
data items that HHAs already report to CMS for quality reporting 
purposes, and therefore, the burden is accounted for in the PRA package 
approved under OMB control number 0938-1279 (expiration November 30, 
2025).
    As discussed in section III.C.2. of this proposed rule, we propose 
to remove a measure from the HH QRP, the Application of Percent of 
Long-Term Care Hospital Patients with an Admission and Discharge 
Functional Assessment and a Care Plan That Addresses Function 
(Application of Functional Assessment/Care Plan) measure, beginning 
with admission assessments completed on January 1, 2025. We have also 
proposed to remove OASIS items for Self-Care Discharge Goals (that is, 
GG0130, Column 2) and Mobility Discharge Goals (that is, GG0170, Column 
2) at the start of care and resumption of care timepoints with the next 
release of the OASIS in 2025. This amounts to a net reduction in 2 data 
elements. We assume that each data element requires 0.3 minutes of 
clinician time to complete. Therefore, we estimate that there would be 
a reduction in clinician burden per OASIS assessment of 0.3 minutes at 
start of care and 0.3 minutes at resumption of care.
    As stated in section III.C.3. of this proposed rule, we propose to 
adopt the COVID-19 Vaccine: Percent of Patients/Residents Who Are Up to 
Date (Patient/Resident COVID-19 Vaccine) measure beginning with the CY 
2025 HH QRP. This proposed assessment-based quality measure would be 
collected using the OASIS. The OASIS-E is currently approved under OMB 
control number 0938-1279 (CMS-10387). One data element would need to be 
added to the OASIS at the transfer of care, death at home, and 
discharge time points in order to allow for the collection of the 
Patient/Resident COVID-19 Vaccine measure. We assume this would result 
in an increase 0.3 minutes of clinician staff time at the transfer of 
care, death at home, and discharge time points starting with the CY 
2025 HH QRP.
    As stated in section III.E.3. of this proposed rule, we propose to 
remove the M0110--Episode Timing and M2220- Therapy Needs OASIS items, 
effective January 1, 2025. These items are no longer used by the HH 
QRP, nor are they intended for use by CMS payment, survey or the 
expanded HHVBP model. The removal of these two items would result in 
the removal of two data elements at start of care, two at resumption of 
care, and one data element at follow-up for a total reduction of five 
data elements.
    The net effect of the proposals outlined in this proposed rule is a 
reduction in four data elements collected across all time points for 
the OASIS implemented on January 1, 2025.

[[Page 43791]]

Table G1 outlines the net change in data elements.
[GRAPHIC] [TIFF OMITTED] TP10JY23.083

    The OASIS is completed by RNs or PTs, or very occasionally by 
occupational therapists (OT) or speech language pathologists (SLP/ST). 
Data from 2021 show that the SOC/ROC OASIS is completed by RNs 
(approximately 77.14 percent of the time), PTs (approximately 22.16 
percent of the time), and other therapists, including OTs and SLP/STs 
(approximately 0.7 percent of the time). Based on this analysis, we 
estimated a weighted clinician average hourly wage of $87.52, inclusive 
of fringe benefits, using the hourly wage data in Table G1. Individual 
providers determine the staffing resources necessary.
    For purposes of calculating the costs associated with the 
information collection requirements, we obtained mean hourly wages for 
these from the U.S. Bureau of Labor Statistics' May 2022 National 
Occupational Employment and Wage Estimates (https://www.bls.gov/oes/current/oes_nat.htm). To account for other indirect costs such as 
overhead and fringe benefits (100 percent), we have doubled the hourly 
wage. These amounts are detailed in Table G2.
[GRAPHIC] [TIFF OMITTED] TP10JY23.084

    For purposes of estimating burden, we utilize item-level burden 
estimates for OASIS-E that will be released on January 1, 2025 compared 
to the OASIS-E as currently implemented as of January 1, 2023. Table G3 
shows the total number of OASIS assessments that HHAs actually 
completed in CY 2021, as well as how those numbers would have decreased 
if non-Medicare and non-Medicaid OASIS assessments had been required at 
that time.
[GRAPHIC] [TIFF OMITTED] TP10JY23.085

    Table G4 summarizes the estimated clinician hourly burden for the 
current OASIS and the OASIS in 2025 with the net removal of four data 
elements for each OASIS assessment type using CY 2021 assessment 
totals. We estimate a

[[Page 43792]]

net reduction of 58,540.1 hours of clinician burden across all HHAs or 
5 hours for each of the 11,700 active HHAs.
[GRAPHIC] [TIFF OMITTED] TP10JY23.086

    Table G5 summarizes the estimated clinician costs for the current 
OASIS and the OASIS in 2025 with the net removal of four data elements 
for each OASIS assessment type using CY 2021 assessment totals. We 
estimate a reduction in costs of $5,123,429.55 related to the 
implementation of the proposals outlined in this proposed rule across 
all HHAs or a $437 reduction for each of the 11,700 active HHAs. This 
reduction in burden would begin with January 1, 2025 HHA discharges.
[GRAPHIC] [TIFF OMITTED] TP10JY23.087

2. ICRs for HHVBP
    The proposals for the expanded HHVBP Model included in this 
proposed rule do not result in an increase in costs to HHAs. Section 
1115A(d)(3) of the Act exempts Innovation Center model tests and 
expansions, which include the expanded HHVBP Model, from the provisions 
of the PRA. Specifically, this section provides that the provisions of 
the PRA do not apply to the testing and evaluation of Innovation Center 
models or to the expansion of such models.
3. ICRs for Hospice Information Dispute Resolution (IDR) and Hospice 
Special Focus Program (SFP)
    In accordance with 5 CFR 1320.4(a)(2) and (c), the following 
information collection activities are exempt from the requirements of 
the Paperwork Reduction Act since they are associated with 
administrative actions: (1) proposed Sec.  488.1130 Hospice IDR; and 
(2) proposed Sec.  488.1135 Hospice SFP.
4. ICRs for DMEPOS Refills
    In section VII.E. of this proposed rule, we are proposing to codify 
our refill policy, with some changes. The policy originally arose in 
response to concerns related to auto-shipments and delivery of DMEPOS 
products that may no longer be needed or not needed at the same level 
of frequency/volume. The policy has been historically maintained in the 
Medicare Program Integrity Manual, sporadically mentioned in certain 
Local Coverage Determinations (LCDs), and detailed in articles. We 
propose to require documentation indicating that the beneficiary 
confirmed the need for the refill within the 30-day period prior to the 
end of the current supply. We propose to codify our requirement that 
delivery of DMEPOS items (that is, date of service) must be no sooner 
than 10 calendar days before the expected end of the current supply.
5. ICRs for Provider Enrollment Provisions
    Except as explained in this section IX. of this proposed rule, we 
do not anticipate that any of our proposed provider enrollment 
provisions would implicate an ICR burden.
a. High-Risk Screening and Fingerprinting
    We are proposing to revise Sec.  424.518 to: (1) move initially 
enrolling hospices (and those undergoing an ownership change as 
described in Sec.  424.518) into the high-risk screening category; and 
(2) include within the high-risk screening category revalidating DMEPOS 
suppliers, HHAs, OTPs, MDPPs, and SNFs for whom CMS legally waived the 
fingerprint-based criminal background check requirement in Sec.  
424.518 when they initially enrolled in Medicare. These changes would 
result in an increase in the annual number of providers and suppliers 
that must submit the fingerprints for a national

[[Page 43793]]

criminal background check (via FBI Applicant Fingerprint Card FD-258) 
of all individuals with a 5 percent or greater direct or indirect 
ownership interest in the provider or supplier. The burden is currently 
approved by OMB under control number 1110-0046. We are not scoring the 
burden under this ICR section since the fingerprint card is not owned 
by CMS. However, an analysis of the impact of this requirement can be 
found in the RIA section of this proposed rule.
b. Hospice 36-Month Rule
    We are proposing to expand Sec.  424.550(b) to apply the 36-month 
rule provisions therein to hospices. This would require a hospice 
undergoing a change in majority ownership (as defined in Sec.  424.502 
and assuming no exceptions apply) to: (1) enroll in Medicare as a new 
hospice; and (2) undergo a state survey or accreditation. The principal 
ICR burden of this requirement would involve the completion of an 
initial Form CMS-855A application rather than a Form CMS-855A change of 
ownership (CHOW) application or a Form CMS-855A change of information 
application. Consistent with the general time estimates for these three 
categories of applications, it typically takes a provider approximately 
4 hours to complete an initial Form CMS-855A, 4 hours for a CHOW 
application, and 1 hour for a change of information application. The 
key ICR burden difference, therefore, would be between submitting an 
initial application and submitting a change of information (since there 
is no burden difference between an initial application and a CHOW 
application).
    Based on internal CMS data, we estimate that each year 
approximately 50 hospices would be required to initially enroll in 
Medicare due to a change in majority ownership as opposed to simply 
reporting the sale via a change of information. This would result in an 
additional Form CMS-855A hour burden of 150 hours (50 x 3 hours), with 
the 3-hour figure reflecting the difference between initial 
applications and changes of information. In terms of cost, it has been 
our experience that Form CMS-855A applications are completed by the 
provider's office staff. Consequently, we will use the following wage 
category and hourly rate from the U.S. Bureau of Labor Statistics' 
(BLS) May 2022 National Occupational Employment and Wage Estimates for 
all salary estimates (http://www.bls.gov/oes/current/oes_nat.htm):
[GRAPHIC] [TIFF OMITTED] TP10JY23.088

    This results in an additional Form CMS-855A annual cost burden of 
$6,225 (150 hours x $41.50).
    We anticipate the following additional costs associated with our 
36-month rule expansion:
     Fingerprinting: As we proposed that hospices would be 
subject to high-risk level screening under Sec.  424.518, hospices that 
must initially enroll under Sec.  424.550(b) would have to submit a set 
of fingerprints for a national criminal background check (via FBI 
Applicant Fingerprint Card FD-258) from each individual with a 5 
percent or greater direct or indirect ownership interest in the 
hospice. An analysis of the impact of this requirement can be found in 
section X.C.8.of this proposed rule.
     Application Fee: Under Sec.  424.514, an institutional 
provider (as that term is defined in Sec.  424.502) that is initially 
enrolling in Medicare must pay the required application fee. Hospices 
that are initially enrolling in accordance with the 36-month rule would 
accordingly have to pay this fee. The application fee does not meet the 
definition of a ``collection of information'' and, as such, is not 
subject to the requirements of the PRA. However, the cost is scored 
under section X.C.8. of this proposed rule.
     Provider Agreement: A hospice that is initially enrolling 
in Medicare (which would include those doing so in accordance with 
Sec.  424.550(b)) must also sign a provider agreement per 42 CFR part 
489 (Health Insurance Benefits Agreement--CMS Form 1561 (OMB control 
number 0938-0832)). The applicable May 2022 BLS categories and hourly 
wage rates for completing this form are as follows:
[GRAPHIC] [TIFF OMITTED] TP10JY23.089

    We anticipate that 100 hospices per year would have to sign this 
provider agreement due to our revision to Sec.  424.550(b): the 50 
previously referenced hospices that would otherwise have reported the 
ownership

[[Page 43794]]

change via a Form CMS-855A change of information and another 50 that 
would have done so via a Form CMS-855A CHOW application. We anticipate 
that it would take the hospice 5 minutes at $236.96/hr for a chief 
executive to review and sign the Form CMS-1561 and an additional 5 
minutes at $39.68/hr for a medical secretary to file the document when 
fully executed. This results in an annual hour burden of 17 hours (100 
x 0.166 hours) and a cost of $2,305 (or (($236.96 x 0.0833) + ($39.68 x 
0.0833)) x 100).
    Combining these initial enrollment application and provider 
agreement ICR costs associated with a hospice's change in majority 
ownership results in an annual burden of 167 hours (150 + 17) and a 
cost of $8,530 ($6,225 + $2,305).
    We solicit comment from stakeholders, including hospices, regarding 
any other ICR costs that may be associated with our proposed expansion 
of the 36-month rule to incorporate hospices. This could include ICR 
costs incurred during the survey, accreditation, or certification 
processes.
c. Remaining Provider Enrollment Provisions
    With one exception, we do not believe our other provider enrollment 
proposals would result in an information collection burden. Concerning 
the proposal in revised Sec.  424.540(a)(1) to reduce the timeframe in 
which CMS can deactivate a provider or supplier for non-billing from 12 
months to 6 months, an increase in the number of deactivations on this 
basis could result. However, we are unable to establish an estimate of 
this number or any associated burden for two reasons. First, fraud 
schemes change and fluctuate, meaning that CMS cannot predict the 
number of instances in which it would apply Sec.  424.540(a)(1) to 
address such situations. Second, a deactivation is a purely 
discretionary action by CMS; that is, CMS can, but is not required to, 
impose a deactivation if a basis for doing so exists. Accordingly, we 
are unable to quantify the increase, if any, of cases where we would 
invoke revised Sec.  424.540(a)(1).

C. Submission of PRA-Related Comments

    We have submitted a copy of this final rule to OMB for its review 
of the rule's information collection requirements. The requirements are 
not effective until they have been approved by OMB.
    To obtain copies of the supporting statement and any related forms 
for the proposed collections, as previously discussed, please visit the 
CMS website at https://www.cms.hhs.gov/PaperworkReductionActof1995, or 
call the Reports Clearance Office at 410-786-1326.
    We invite public comments on these potential information collection 
requirements.

X. Regulatory Impact Analysis

A. Statement of Need

1. HH PPS
    Section 1895(b)(1) of the Act requires the Secretary to establish a 
HH PPS for all costs of home health services paid under Medicare. In 
addition, section 1895(b) of the Act requires: (1) the computation of a 
standard prospective payment amount include all costs for home health 
services covered and paid for on a reasonable cost basis and that such 
amounts be initially based on the most recent audited cost report data 
available to the Secretary; (2) the prospective payment amount under 
the HH PPS to be an appropriate unit of service based on the number, 
type, and duration of visits provided within that unit; and (3) the 
standardized prospective payment amount be adjusted to account for the 
effects of case-mix and wage levels among HHAs. Section 1895(b)(3)(B) 
of the Act addresses the annual update to the standard prospective 
payment amounts by the home health applicable percentage increase. 
Section 1895(b)(4) of the Act governs the payment computation. Sections 
1895(b)(4)(A)(i) and (b)(4)(A)(ii) of the Act requires the standard 
prospective payment amount be adjusted for case-mix and geographic 
differences in wage levels. Section 1895(b)(4)(B) of the Act requires 
the establishment of appropriate case-mix adjustment factors for 
significant variation in costs among different units of services. 
Lastly, section 1895(b)(4)(C) of the Act requires the establishment of 
wage adjustment factors that reflect the relative level of wages, and 
wage-related costs applicable to home health services furnished in a 
geographic area compared to the applicable national average level.
    Section 1895(b)(3)(B)(iv) of the Act provides the Secretary with 
the authority to implement adjustments to the standard prospective 
payment amount (or amounts) for subsequent years to eliminate the 
effect of changes in aggregate payments during a previous year or years 
that were the result of changes in the coding or classification of 
different units of services that do not reflect real changes in case-
mix. Section 1895(b)(5) of the Act provides the Secretary with the 
option to make changes to the payment amount otherwise paid in the case 
of outliers because of unusual variations in the type or amount of 
medically necessary care. Section 1895(b)(3)(B)(v) of the Act requires 
HHAs to submit data for purposes of measuring health care quality, and 
links the quality data submission to the annual applicable percentage 
increase.
    Sections 1895(b)(2) and 1895(b)(3)(A) of the Act, as amended by 
section 51001(a)(1) and 51001(a)(2) of the BBA of 2018 respectively, 
required the Secretary to implement a 30-day unit of service, for 30-
day periods beginning on and after January 1, 2020. Section 
1895(b)(3)(D)(i) of the Act, as added by section 51001(a)(2)(B) of the 
BBA of 2018, requires the Secretary to annually determine the impact of 
differences between assumed behavior changes, as described in section 
1895(b)(3)(A)(iv) of the Act, and actual behavior changes on estimated 
aggregate expenditures under the HH PPS with respect to years beginning 
with 2020 and ending with 2026. Section 1895(b)(3)(D)(ii) of the Act 
requires the Secretary, at a time and in a manner determined 
appropriate, through notice and comment rulemaking, to provide for one 
or more permanent increases or decreases to the standard prospective 
payment amount (or amounts) for applicable years, on a prospective 
basis, to offset for such increases or decreases in estimated aggregate 
expenditures, as determined under section 1895(b)(3)(D)(i) of the Act. 
Additionally, 1895(b)(3)(D)(iii) of the Act requires the Secretary, at 
a time and in a manner determined appropriate, through notice and 
comment rulemaking, to provide for one or more temporary increases or 
decreases to the payment amount for a unit of home health services for 
applicable years, on a prospective basis, to offset for such increases 
or decreases in estimated aggregate expenditures, as determined under 
section 1895(b)(3)(D)(i) of the Act. The HH PPS wage index utilizes the 
wage adjustment factors used by the Secretary for purposes of sections 
1895(b)(4)(A)(ii) and (b)(4)(C) of the Act for hospital wage 
adjustments.
2. HH QRP
    Section 1895(b)(3)(B)(v) of the Act authorizes the HH QRP, which 
requires HHAs to submit data in accordance with the requirements 
specified by CMS. Failure to submit data required under section 
1895(b)(3)(B)(v) of the Act with respect to a program year will result 
in the reduction of the annual home health market basket percentage 
increase otherwise applicable to an HHA for the corresponding calendar 
year by 2 percentage points.

[[Page 43795]]

3. Expanded HHVBP Model
    In the CY 2022 HH PPS final rule (86 FR 62292 through 62336) and 
codified at 42 CFR part 484 subpart F, we finalized our policy to 
expand the HHVBP Model to all Medicare certified HHAs in the 50 States, 
territories, and District of Columbia beginning January 1, 2022. CY 
2022 was a pre-implementation year. CY 2023 is the first performance 
year in which HHAs individual performance on the applicable measures 
will affect their Medicare payments in CY 2025. In this proposed rule, 
we are proposing to remove five quality measures from the current 
applicable measure set and add three quality measures to the applicable 
measure set. Along with the proposed revisions to the current measure 
set, we propose to revise the weights of the individual measures within 
the OASIS-based measure category and within the claims-based measure 
category starting in the CY 2025 performance year. In addition, we are 
proposing to update the Model baseline year from CY 2022 to CY 2023 
starting in the CY 2025 performance year to enable CMS to measure 
competing HHAs performance on benchmarks and achievement thresholds 
that are more current for the proposed applicable measure set. 
Additionally, we are amending the appeals process such that 
reconsideration decisions may be reviewed by the Administrator. We are 
including an update to the RFI, Future Approaches to Health Equity in 
the Expanded HHVBP Model, that was published in the CY 2023 HH PPS 
rule. We will also include an update that reminds interested parties 
that we will begin public reporting of HHVBP performance data on or 
after December 1, 2024.
4. Home IVIG Items and Services
    Division FF, section 4134 of the CAA, 2023 (CAA, 2023) (Pub. L. 
117-328) mandated that CMS establish a permanent, bundled payment for 
items and services related to administration of IVIG in a patient's 
home. The permanent, bundled home IVIG items and services payment is 
effective for home IVIG infusions furnished on or after January 1, 
2024. Payment for these items and services is required to be a separate 
bundled payment made to a supplier for all items and services furnished 
in the home during a calendar day. This payment amount may be based on 
the amount established under the Demonstration. The standard Part B 
coinsurance and the Part B deductible apply. The separate bundled 
payment does not apply for individuals receiving services under the 
Medicare home health benefit. The CAA, 2023 provision clarifies that a 
supplier who furnishes these services meet the requirements of a 
supplier of medical equipment and supplies.
5. Informal Dispute Resolution (IDR) and Hospice Special Focus Program 
(SFP)
    The proposed hospice IDR would be an administrative process offered 
to hospice programs that is conducted by CMS, the SAs, or the 
accrediting organizations (AOs) as applicable, as part of their survey 
activities to provide an informal opportunity to address survey 
findings. The proposed Hospice SFP would be implementing a part of the 
hospice provisions required under the CAA 2021 directing the Secretary 
to create an SFP for poor-performing hospice programs.
6. DMEPOS CAA, 2023-Related Requirements
a. Conforming Changes to Regulations To Codify Change Mandated by 
Section 4139 of the Consolidated Appropriations Act, 2023
    The purpose of the provision related to adjusted fees is to extend 
the 75/25 blend in non-rural, non-CBAs as described in 42 CFR 
414.210(g)(9)(v). The statutory language for this provision is found in 
section 4139 of the CAA, 2023.
b. Scope of the Benefit and Payment for Lymphedema Compression 
Treatment Items
    The purpose of the provision related to lymphedema compression 
treatment items is to define in regulation section 4133 of the CAA, 
2023 that adds section 1861(s)(2)(JJ) to the Act establishing a 
Medicare Part B benefit for lymphedema compression treatment item. This 
provision would address the scope of the new benefit by defining what 
constitutes a standard or custom fitted gradient compression garment 
and determining what other compression items may exist that are used 
for the treatment of lymphedema and would fall under the new benefit. 
This rule would also implement section 1834(z) of the Act in 
establishing payment amounts for items covered under the new benefit 
and frequency limitations for lymphedema compression treatment items.
c. Definition of Brace
    The purpose of the provision related to the definition of a brace 
is to codify in regulations the longstanding definition of brace that 
exists in Medicare program instructions.
7. Requirements for Refillable DMEPOS
    This provision is needed to require documentation indicating that 
the beneficiary confirmed the need for the refill within the 30-day 
period prior to the end of the current supply and to codify our 
requirement that the delivery of DMEPOS items (that is, date of 
service) must be no sooner than 10 calendar days before the expected 
end of the current supply.
8. Provider Enrollment Provisions
    This proposed rule is needed to make regulatory enhancements to our 
provider enrollment policies. These provisions focus on, but are not 
limited to: (1) subjecting a greater number of providers and suppliers, 
such as hospices, to the highest level of screening, which includes 
fingerprinting all 5 percent or greater owners of these providers and 
suppliers; and (2) applying the change in majority ownership (CIMO) 
provisions in 42 CFR 424.550(b) to hospices. These changes are 
necessary to help ensure that payments are made only to qualified 
providers and suppliers and that owners of these entities are carefully 
screened. As explained in section VIII. of this proposed rule, we 
believe that fulfilling both of these objectives would assist in 
protecting the Trust Funds and Medicare beneficiaries.

B. Overall Impact

    We have examined the impacts of this rule as required by Executive 
Order 12866 on Regulatory Planning and Review (September 30, 1993), 
Executive Order 13563 on Improving Regulation and Regulatory Review 
(January 18, 2011), Executive Order 14094 on Modernizing Regulatory 
Review (April 6, 2023), the Regulatory Flexibility Act (RFA) (September 
19, 1980, Pub. L. 96 354), section 1102(b) of the Act, section 202 of 
the Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-
4), Executive Order 13132 on Federalism (August 4, 1999), and the 
Congressional Review Act (5 U.S.C. 804(2)).
    Executive Orders 12866 and 13563 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). Executive 
Order 14094 amends section 3(f) of Executive Order 12866 to define a 
``significant regulatory action'' as an action that is likely to result 
in a rule: (1) having an annual effect on the

[[Page 43796]]

economy of $200 million or more in any 1 year, or adversely affect in a 
material way the economy, productivity, competition, jobs, the 
environment, public health or safety, or State, local or tribal 
governments or communities; (2) creating a serious inconsistency or 
otherwise interfering with an action taken or planned by another 
agency; (3) materially altering the budgetary impacts of entitlement 
grants, user fees, or loan programs or the rights and obligations of 
recipients thereof; or (4) raising legal or policy issues for which 
centralized review would meaningfully further the President's 
priorities or the principles set forth in this Executive Order.
    A regulatory impact analysis (RIA) must be prepared for major rules 
with significant regulatory action/s and/or with significant effects as 
per section 3(f)(1) of $200 million or more in any 1 year. Based on our 
estimates, OMB'S Office of Information and Regulatory Affairs has 
determined this rulemaking is significant per section 3(f)(1) as 
measured by the $200 million or more in any 1 year. According we have 
prepared a regulatory impact analysis that to the best of our ability 
presents the costs and benefits of the rulemaking. Therefore, OMB has 
reviewed this proposed rule, and the Departments have provided the 
following assessment of their impact. We solicit comments on the 
regulatory impact analysis provided.

C. Detailed Economic Analysis

1. Effects of the Proposed Changes for the CY 2024 HH PPS
    This rule proposes to update Medicare payments under the HH PPS for 
CY 2024. The net transfer impact related to the changes in payments 
under the HH PPS for CY 2024 is estimated to be -$375 million (-2.2 
percent). The $375 million decrease in estimated payments for CY 2024 
reflects the effects of the proposed CY 2024 home health payment update 
percentage of 2.7 percent ($460 million increase), an estimated 5.1 
percent decrease that reflects the effects of the permanent behavior 
adjustment ($870 million decrease) and an estimated 0.2 percent 
increase that reflects the effects of an updated FDL ($35 million 
increase).
    We use the latest data and analysis available. However, we do not 
adjust for future changes in such variables as number of visits or 
case-mix. This analysis incorporates the latest estimates of growth in 
service use and payments under the Medicare home health benefit, based 
primarily on Medicare claims data for periods that ended on or before 
December 31, 2022. We note that certain events may combine to limit the 
scope or accuracy of our impact analysis, because such an analysis is 
future-oriented and, thus, susceptible to errors resulting from other 
changes in the impact time period assessed. Some examples of such 
possible events are newly-legislated general Medicare program funding 
changes made by the Congress or changes specifically related to HHAs. 
In addition, changes to the Medicare program may continue to be made as 
a result of new statutory provisions. Although these changes may not be 
specific to the HH PPS, the nature of the Medicare program is such that 
the changes may interact, and the complexity of the interaction of 
these changes could make it difficult to predict accurately the full 
scope of the impact upon HHAs.
    Table GG 1 represents how HHA revenues are likely to be affected by 
the finalized policy changes for CY 2024. For this analysis, we used an 
analytic file with linked CY 2022 OASIS assessments and home health 
claims data for dates of service that ended on or before December 31, 
2022. The first column of Table GG 1 classifies HHAs according to a 
number of characteristics including provider type, geographic region, 
and urban and rural locations. The second column shows the number of 
facilities in the impact analysis. The third column shows the payment 
effects of the permanent behavior assumption adjustment on all 
payments. The aggregate impact of the permanent BA adjustment reflected 
in the third column does not equal the proposed -5.653 percent 
permanent BA adjustment because the adjustment only applies to the 
national, standardized 30-day period payments and does not impact 
payments for 30-day periods which are LUPAs. The fourth column shows 
the payment effects of the recalibration of the case-mix weights offset 
by the case-mix weights budget neutrality factor. The fifth column 
shows the payment effects of updating the CY 2024 wage index with a 5-
percent cap on wage index decreases. The sixth column shows the effect 
of the proposed CY 2024 labor-related share. The aggregate impact of 
the changes in the fifth and sixth columns is zero percent, due to the 
wage index budget neutrality factor and the labor-related share budget 
neutrality factor. The seventh column shows the payment effects of the 
proposed CY 2024 home health payment update percentage. The eighth 
column shows the payment effects of the revised FDL, and the last 
column shows the combined effects of all the proposed provisions.
    Overall, it is projected that aggregate payments in CY 2024 would 
decrease by 2.2 percent which reflects the 5.1 percent decrease from 
the permanent behavior adjustment, the 2.7 payment update percentage 
increase, and the 0.2 percent increase from decreasing the FDL. As 
illustrated in Table GG 1, the combined effects of all of the changes 
vary by specific types of providers and by location. We note that some 
individual HHAs within the same group may experience different impacts 
on payments than others due to the distributional impact of the CY 2024 
wage index, the percentage of total HH PPS payments that were subject 
to the LUPA or paid as outlier payments, and the degree of Medicare 
utilization.
BILLING CODE 4120-01-P

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[GRAPHIC] [TIFF OMITTED] TP10JY23.090


[[Page 43798]]


[GRAPHIC] [TIFF OMITTED] TP10JY23.091

BILLING CODE 4120-01-C
2. Effects of the Proposed Changes for the HH QRP for CY 2024
    Failure to submit HH QRP data required under section 
1895(b)(3)(B)(v) of the Act with respect to a program year will result 
in the reduction of the annual home health market basket percentage 
increase otherwise applicable to an HHA for the corresponding calendar 
year by 2 percentage points. For the CY 2023 program year, 820 of the 
11,549 active Medicare-certified HHAs, or approximately 7.1 percent, 
did not receive the full annual percentage increase because they did 
not meet assessment submission requirements. The 820 HHAs that did not 
satisfy the reporting requirements of the HH QRP for the CY 2023 
program year represent $149 million in home health claims payment 
dollars during the reporting period out of a total $16.4 billion for 
all HHAs.
    This proposed rule proposes the adoption of the ``COVID-19 Vaccine: 
Percent of Patients/Residents Who Are Up to Date'' (Patient/Resident 
COVID-19 Vaccine) measure to the HH QRP beginning with the CY 2025 HH 
QRP. CMS also proposes to adopt the ``Functional Discharge Score'' (DC 
Function) measure to the HH QRP beginning with the CY 2025 HH QRP. With 
the addition of the Discharge Function measure, we propose to remove 
the ``Application of Percent of Long-Term Care Hospital (LTCH) Patients 
with an Admission and Discharge Functional Assessment and a Care Plan 
That Addresses Function'' (Application of Functional Assessment/Care 
Plan) measure from the HH QRP beginning with the CY 2025 HH QRP. CMS 
additionally propose the removal of two OASIS items no longer necessary 
for collection, the M0110--``Episode Timing'' and M2220--``Therapy 
Needs'' items. The net effect of these proposals is a reduction of four 
data elements across all OASIS data collection time points and a net 
reduction in burden.
    Section IX.B.1. of this proposed rule provides a detailed 
description of the net decrease in burdens associated with the proposed 
changes. We proposed that additions and removal of data elements 
associated with the HH QRP proposals would begin with January 1, 2025 
discharges. The cost impact of this proposed changes was estimated to 
be a net decrease of $5,123,429 in annualized cost to HHAs, discounted 
at 7 percent relative to year 2021, over a perpetual time horizon 
beginning in CY 2025. We described the estimated burden and cost 
reductions for these measures in section IX of this proposed rule. In 
summary, the implementation of proposals outlined in this proposed rule 
for the HH QRP is estimated to decrease the burden on HHAs by $437 per 
HHA annually, or $5,123,429 for all HHAs annually.
3. Effects of the Proposed Changes for the Expanded HHVBP Model
    In the CY 2023 HH PPS final rule (87 FR 66883), we estimated that 
the expanded HHVBP Model would generate a total projected 5-year gross 
FFS savings for CYs 2023 through 2027 of $3,376,000,000. The proposed 
changes to the applicable measure set and the Model baseline year in 
this proposed rule will not change those estimates because they do not 
change the number of HHAs in the Model or the payment methodology.
    Based on proposed policies discussed in this proposed rule, Tables 
GG2A and GG2B display the distribution of possible payment adjustments 
using CY 2021 data as the performance year and CY 2019 for the baseline 
year. Note that due to limited data availability, this impact analysis 
does not account for improvement points for the PPH measure because 
this measure is not available based on CY 2022 data at the time of the 
release of this proposed rule.
    Table GG2A and GG2B shows the value-based incentive payment 
adjustments for the estimated 6,750 HHAs that would qualify to compete 
in the expanded Model based on CY 2021 performance data stratified by 
volume-based cohort, as defined in section III.F. of the CY 2022 HH PPS 
final rule (86 FR 62312). This impact analysis used CY 2019 to 
determine HHA size instead of the calendar year prior to the 
performance year (that is, CY 2020) to avoid using data impacted by the 
Public Health Emergency (PHE). Using CY 2021 performance year data and 
the finalized payment adjustment of 5 percent, based on the 10 proposed 
quality measures, the 6,504 HHAs in the larger-volume cohort would have 
an average payment adjustment of positive 0.164 percent (+0.164 
percent). Furthermore, 246 HHAs have fewer than 60 unique beneficiaries 
in CY 2019 and are, therefore, included in the smaller-volume cohort. 
Overall, smaller-volume HHAs would have an average payment adjustment 
of negative 0.114 percent (-0.114 percent). Twenty-four states/
territories do not have any HHAs in the smaller-volume cohort, 
including

[[Page 43799]]

Alabama, District of Columbia, and Georgia. The remaining states/
territories have HHAs in both volume-based cohorts. Florida, for 
example, has 622 HHAs in the larger-volume cohort with an average 
payment adjustment of positive 1.154 percent (+1.154 percent) and 17 
HHAs in the smaller-volume cohort with an average payment adjustment of 
positive 0.102 percent (+0.102 percent). The next columns provide the 
distribution of payment adjustment by percentile. Specifically, 10 
percent of HHAs in the larger-volume cohort would receive downward 
payment adjustments of more than negative 3.851 percent (-3.851 
percent). Among smaller-volume HHAs, 10 percent of HHAs would receive 
downward payment adjustments of more than negative 4.120 percent (-
4.120 percent). For larger-volume HHAs in Florida, the payment 
adjustments range from negative 3.161 percent (-3.161 percent) at the 
10th percentile to positive 5.000 percent (+5.000 percent) at the 90th 
percentile, while the median (50th percentile) payment adjustment is 
positive 1.160 percent (+1.160 percent).
    Table GG3 provides the payment adjustment distribution based on the 
proportion of dual-eligible beneficiaries, average case mix using 
Hierarchical Condition Category (HCC) scores, proportion of 
beneficiaries that reside in rural areas, and HHA organizational 
status. To define cutoffs for the ``percentage of dual eligible 
beneficiaries,'' low through high percentage dual-eligible are based on 
the 20th, 40th, 60th, and 80th percentiles of percent dual eligible 
beneficiaries, respectively, across HHAs in CY 2021. To define case mix 
cutoffs, low, medium, or high acuity are based on less than the 25th 
percentile, between the 25th and 75th percentiles, and greater than the 
75th percentile of average HCC scores, respectively, across HHAs in CY 
2021. To define cutoffs for percentage of rural beneficiaries, all non-
rural, up to 50 percent rural, and over 50 percent rural are based on 
the home health beneficiaries' core-based statistical area (CBSA) urban 
versus rural designation. Based on CY 2021 data, HHAs with the highest 
proportion of dual-eligible beneficiaries served have a positive 
average payment adjustment (+0.035 percent). In addition, a higher 
proportion of rural beneficiaries served is associated with better 
performance. Specifically, HHAs serving over 50 percent rural 
beneficiaries have an average payment adjustment of positive 0.728 
percent (+0.728 percent), compared to HHAs serving only rural 
beneficiaries or HHAs serving up to 50 percent rural beneficiaries. 
Among organizational type, proprietary HHAs have a slightly negative 
average payment adjustment of 0.092, whereas HHAs in other 
organizational type categories have a positive average payment 
adjustment.
BILLING CODE 4120-01-P

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BILLING CODE 4120-01-C

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4. Impacts of Home IVIG Items and Services
    The following analysis applies to the home IVIG items and services 
payment rate as set forth in section V.D.1. of this rule as added by 
section 4134 of the CAA, 2023 and accordingly, describes the impact for 
CY 2024 only. Table GG 5 represents the estimated costs of home IVIG 
users for CY 2024. We used CY 2022 data to identify beneficiaries 
actively enrolled in the IVIG demonstration (that is, beneficiaries 
with Part B claims that contain the Q2052 HCPCS code) to estimate the 
number of potential CY 2024 active enrollees in the new benefit, which 
are shown in column 2. In column 3, CY 2022 claims for IVIG visits 
under the Demonstration were again used to estimate potential 
utilization under the new benefit in CY 2024. Column 4 shows the 
proposed CY 2024 home IVIG items and services rate. The fifth column 
estimates the cost to Medicare for CY 2024 ($8,779,095). The estimated 
cost for CY 2023 under the Demonstration is $8,543,520 (not shown in 
chart) resulting in an increase of $235,575 in payments to providers 
under the permanent benefit. Table GG 6 represents the estimated 
impacts of the home IVIG items and services payment for CY 2024 by 
census region.
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5. Effects of the Proposed Changes for Hospice IDR and SFP
    The proposed hospice IDR is an administrative process to be 
conducted by CMS, SAs, or AOs as part of their survey activities, and 
is separate from the SFP. SAs and AOs may already have existing IDR 
processes in place for the HHA IDR requirements. The hospice IDR 
requirements will align with HHA. The Congress has already allocated 
$10 million annually to CMS to implement the CAA 2021 hospice survey 
and enforcement provisions, which includes the SFP. Additionally, CMS 
obligates monies to the SAs to carry out survey and certification 
responsibilities under their agreement with the Secretary under section 
1864 of the Act. Therefore, no additional burden will be incurred by 
CMS, SAs, or AOs.
6. Effects of the Proposed Changes for DMEPOS CAA, 2023-Related 
Provisions
a. Conforming Changes to Regulations To Codify Change Mandated by 
Section 4139 of the Consolidated Appropriations Act, 2023
    One benefit of this provision is that it provides additional 
revenue to DMEPOS suppliers. One cost of this provision is that it 
increases the copayments of the Medicare beneficiaries. The transfer 
from the Medicare program to the DMEPOS suppliers of $100 million for 
CY 2023 paid in CY 2023 and CY 2024. The amount of copayments from 
Medicare beneficiaries over the same period is expected to be $30 
million. The Federal share of Medicaid for the copayments for dual 
eligibles is expected to be $5 million and the State share of the 
Medicare payments for this populations is expected to be $4 million.
b. Scope of the Benefit and Payment for Lymphedema Compression 
Treatment Items
    The benefits of this provision are that Medicare enrollees 
suffering from lymphedema will have Medicare pay 80 percent off the 
cost of the lymphedema compression treatment items. This Medicare 
payment should enable more Medicare enrollees suffering from lymphedema 
to access treatment items in the home, reducing both the financial 
burden of lymphedema and, by encouraging earlier treatment, the 
frequency of institutional care for infections or other complications 
of lymphedema. The transfer from the Medicare program to the lymphedema 
compression treatment suppliers is estimated to be $230 million from CY

[[Page 43806]]

2024 to CY 2028. The amount of copayments from Medicare beneficiaries 
over the same period is expected to be $50 million. The Federal share 
of Medicaid expenditures for the copayments of dual eligibles is 
expected to be $9 million and the State share for this population is 
expected to be $6 million.
c. Definition of Brace
    The benefit of this provision is to add the definition of brace in 
regulation to more clearly identify what is included in the definition 
of a brace. This is purely an administrative effort with no impact on 
Medicare coverage or expenditure, and, for this reason, has no cost or 
transfer associated with it.
7. Effects of the Proposed Changes to the Requirements for Refillable 
DMEPOS
    This rule proposes to codify and clarify our requirements for 
refillable DMEPOS items. The fiscal impact of these requirements cannot 
be estimated as claims often deny for multiple reasons, which may 
include non-compliance with our refill requirements; creating an 
inability for us to accurately demonstrate a causal relationship. In 
addition, to demonstrate impacts we would have to be able to predict 
behaviors and anticipated non-compliance in future claim submissions, 
which are unknown variables to us.
8. Effects of the Proposed Changes Regarding for Provider Enrollment 
Requirements
    There are four principal impacts of our provider enrollment 
proposals outlined in section VIII. of this proposed rule.
    The first was addressed in section IX. and involves the ICR burden 
associated with a hospice's completion of an initial Form CMS-855A 
application and Form CMS-1561 provider agreement in accordance with a 
Sec.  424.550(b) change in majority ownership for which an exception 
does not apply. The combined annual burden was estimated to be 167 
hours at a cost of $8,530.
    The second involves moving hospices from the moderate-risk 
screening category to the high-risk screening level.
    The third involves incorporating within the high-risk screening 
category revalidating DMEPOS suppliers, HHAs, OTPs, MDPP suppliers, and 
SNFs for which CMS waived the fingerprint-based criminal background 
check requirement when they initially enrolled in Medicare.
    The fourth involves the fingerprinting and application fee 
requirements (referenced in section IX. of this proposed rule) 
associated with a Sec.  424.550(b) change in majority ownership.
    We address the second, third, and fourth impacts as follows:
a. Moving Hospices to High-Risk
    With this change to Sec.  424.518, hospices that are initially 
enrolling in Medicare or reporting any new owner would have to submit 
the fingerprints of their 5 percent or greater direct or indirect 
owners for a Federal Bureau of Investigation criminal background check. 
Based on enrollment statistics and our experience, we project that 
1,782 hospices per year (425 initially enrolling + 1,357 reporting a 
new 5 percent or greater owner) would be required to submit these 
fingerprints. (This figure does not include hospices initially 
enrolling pursuant to Sec.  424.550(b); this matter is addressed in 
section X.C.8.d. of this proposed rule). Using an estimate of one owner 
per hospice (which aligns with previous fingerprinting projections we 
have made), 1,782 sets of fingerprints per year would be submitted.
    Consistent with prior burden estimates, we project that it would 
take each owner approximately 2 hours to be fingerprinted. According to 
the most recent BLS wage data for May 2022, the mean hourly wage for 
the general category of ``Top Executives'' (the most appropriate BLS 
category for owners) is $62.04. With fringe benefits and overhead, the 
figure is $124.08. This would result in an estimated annual burden of 
this proposed change of 3,564 hours (1,782 x 2) at a cost of $442,221 
(3,564 x $124.08).
b. Providers and Suppliers Previously Waived From Fingerprinting
    Approximately 6,388 high-risk level providers and suppliers were 
waived from fingerprinting when they initially enrolled in Medicare 
during the PHE. We are proposing that these providers and suppliers, 
upon their revalidation, be subject to high-risk category screening 
and, consequently, fingerprinting. Using our estimates from section 
X.C.8.a. of this proposed rule, we project the total burden of this 
proposal to be 12,776 hours (6,388 x 2 hr) and $1,585,246 (12,776 x 
$124.08). Calculated as annual figures over a 3-year period, this 
results in a burden of 4,259 hours and $528,415.
c. Hospice Changes in Majority Ownership
    Hospices that are initially enrolling in Medicare due to a change 
in majority ownership under Sec.  424.550(b) would be subject to 
fingerprinting and must pay an application fee in accordance with Sec.  
424.514. Using the fingerprinting estimates already referenced in 
section X.C.8. of this proposed rule, we estimate an annual 
fingerprinting burden to hospices per Sec.  424.550(b) of 200 hours 
(100 x 2 hr) at a cost of $24,816 (200 hr x $124.08).
    The application fees for each of the past 3 calendar years were or 
are $599 (CY 2021), $631 (CY 2022), and $688 (CY 2023). Consistent with 
Sec.  424.514, the differing fee amounts were predicated on changes/
increases in the CPI for all urban consumers (all items; United States 
city average, CPI-U) for the 12-month period ending on June 30 of the 
previous year. While we cannot predict future changes to the CPI, the 
fee amounts between 2021 and 2023 increased by an average of $45 per 
year. We believe this is a reasonable barometer with which to establish 
estimates (strictly for purposes of this proposed rule) of the fee 
amounts in the first 3 calendar years of the proposed provision (that 
is, 2024, 2025, and 2026). Thus, we project a fee amount of $733 in 
2024, $778 for 2025, and $823 for 2026.
    Applying these prospective fee amounts to the annual number of 
projected hospices impacted by our change in majority ownership 
proposal, this results in a cost of $73,300 (or 100 x $733) in the 
first year, $77,800 in the second year, and $82,300 in the third year.
    Applying these prospective fee amounts to the annual number of 
projected hospices impacted by our change in majority ownership 
proposal, this results in a cost of $73,300 (or 100 x $733) in the 
first year, $77,800 in the second year, and $82,300 in the third year.
d. Totals
    The following table outlines the total annual costs associated with 
the proposals addressed in section X.C.8. of this proposed rule for 
each of the first 3 years.

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    We solicit comment from stakeholders, including hospices, regarding 
any other RIA costs that may be associated with our proposed expansion 
of the 36-month rule to incorporate hospices. This could include costs 
incurred during the survey, accreditation, and/or certification 
processes.

D. Regulatory Review Cost Estimation

    If regulations impose administrative costs on private entities, 
such as the time needed to read and interpret this proposed or final 
rule, we should estimate the cost associated with regulatory review. 
Due to the uncertainty involved with accurately quantifying the number 
of entities that will review the rule, we assume that the total number 
of unique commenters on last year's proposed rule will be the number of 
reviewers of this proposed rule. We acknowledge that this assumption 
may understate or overstate the costs of reviewing this rule. It is 
possible that not all commenters reviewed last year's rule in detail, 
and it is also possible that some reviewers chose not to comment on the 
proposed rule. For these reasons we thought that the number of past 
commenters would be a fair estimate of the number of reviewers of this 
rule. We seek comments on the approach used in estimating the number of 
entities reviewing this proposed rule. We also recognize that different 
types of entities are in many cases affected by mutually exclusive 
sections of this proposed rule, and therefore for the purposes of our 
estimate we assume that each reviewer reads approximately 50 percent of 
the rule. We seek comments on this assumption.
    Using the wage information from the BLS for medical and health 
service managers (Code 11-9111), we estimate that the cost of reviewing 
this rule is $115.22 per hour, including overhead and fringe benefits 
https://www.bls.gov/oes/current/oes_nat.htm. Assuming an average 
reading speed, we estimate that it would take approximately 1.98 hours 
for the staff to review half of this proposed rule. For each entity 
that reviews the rule, the estimated cost is $228.14 (1.98 hours x 
$115.22). Therefore, we estimate that the total cost of reviewing this 
regulation is $205,554.14 ($228.14 x 901) [901 is the number of 
estimated reviewers, which is based on the total number of unique 
commenters from last year's proposed rule].

E. Alternatives Considered

1. HH PPS
    For the CY 2024 HH PPS proposed rule, we considered alternatives to 
the provisions articulated in section II.C. of this proposed rule. As 
described in section II.C.1.g. of this rule, to help prevent future 
over or underpayments, we calculated a permanent prospective adjustment 
by determining what the 30-day base payment amount should have been in 
CYs 2020, 2021, and 2022 in order to achieve the same estimated 
aggregate expenditures as obtained from the simulated 60-day episodes. 
One alternative to the proposed -5.653 percent permanent payment 
adjustment included halving the proposed adjustment similar to how we 
finalized the permanent adjustment for CY 2023. Another alternative 
would be a phase-in approach, where we could reduce the permanent 
adjustment, by spreading out the CY 2024 permanent adjustment over a 
specified period of years, rather than halving the adjustment in CY 
2024 and adjusting the CY 2025 rate by the rest of that amount. Another 
alternative would be to delay the permanent adjustment to a future 
year. However, we believe that a reduction, a phase-in approach, or 
delay in the permanent adjustment would not be appropriate, as 
reducing, phasing in, or delaying the permanent adjustment would 
further impact budget neutrality and likely lead to a compounding 
effect creating the need for a larger reduction to the payment rate in 
future years.
    We also considered proposing to implement the one-time temporary 
adjustment to reconcile retrospective overpayments in CYs 2020, 2021, 
and 2022. However, as stated previously in this rule, we believe that 
implementing both the permanent and temporary adjustments to the CY 
2024 payment rate may adversely affect HHAs given the magnitude of the 
adjustment to the payment rate in a single year. Likewise, section 
1895(b)(3)(D)(iii) of the Act gives CMS the authority to make any 
temporary adjustment in a time and manner appropriate though notice and 
comment rulemaking. Therefore, we believe it is best to propose only 
the implementation of the permanent decrease of 5.653 percent to the CY 
2024 base payment rate.
2. HH QRP
    We considered alternative measures to the Discharge Function 
measure and determined this measure was the strongest. No appropriate 
alternative was available for the COVID-19 Patient Vaccination measure.
3. Expanded HHVBP Model
    We discuss the alternatives we considered to the proposed weights 
of the individual measures within the OASIS-based measure category and 
within the claims-based measure category starting in the CY 2025 
performance year for the expanded HHVBP Model in section IV.B.2. of 
this proposed rule.
4. Home IVIG Items and Services
    For the CY 2024 HH PPS proposed rule, we did not consider 
alternatives to implementing the home IVIG items and services payment 
for CY 2024 because section 1842(o)(8) of the Act requires the 
Secretary to establish a separate bundled payment to the supplier for 
all items and services related to the administration of intravenous 
immune globulin to an individual in the patient's home during a 
calendar day effective January 1, 2024. We did consider alternatives to 
annually updating this payment rate, as articulated in section II.V.D. 
of this proposed rule. We considered updating the annual rate using the 
LUPA rate for skilled nursing in accordance with the demonstration

[[Page 43808]]

program update. However, as the IVIG services payment is not 
geographically wage adjusted, and the LUPA rate incorporates a wage 
index budget neutrality factor, we believe it is more appropriate to 
annually adjust the IVIG items and services payment rate only by the 
home health payment update percentage. We also considered annually 
updating the rate by the CPI-U percentage increase in accordance with 
the annual update to the home infusion therapy services payment rate. 
However, the Demonstration has never used the CPI-U percentage increase 
to update the payment rate, and we believe it is more beneficial to 
keep the permanent payment as closely aligned with the Demonstration 
rate as possible.
5. IDR and Hospice SFP
    We did not consider any alternatives in this proposed rule for 
either proposal. An initial alternative proposal was published in CY 22 
Home Health PPS proposed rule (86 FR 35874) but was not finalized due 
to public comments and requests that CMS establish a Technical Expert 
Panel (TEP) to inform the development of the SFP. We believe the new 
proposed methodology, based on feedback provided by the TEP, is the 
best way to identify and remedy the issue of poor-performing hospices.
6. DMEPOS CAA, 2023-Related Provisions
a. Scope of the Benefit and Payment for Lymphedema Compression 
Treatment Items
    As this provision is statutorily mandated, CMS needed to consider 
no alternatives for implementation. Similarly, the statutory language 
provided a definition for the lymphedema compression treatment items to 
be covered by this benefit, so CMS did not consider any alternative to 
coverage of a list of items meeting the statutory requirements. 
Regarding the payment methodology, CMS considered numerous sources for 
prices as suggested in statute. Different combinations of internet and 
insurer prices were alternatives considered. Ultimately, CMS decided on 
a payment methodology that CMS considered reasonable given the market 
for these items.
b. Conforming Changes to Regulations To Codify Change Mandated by 
Section 4139 of the Consolidated Appropriations Act, 2023
    This is a conforming change to a statutory mandate and therefore 
required no alternatives be considered.
c. Definition of Brace
    This is a codification of an existing definition and therefore 
required no alternatives be considered.
7. Refillable DMEPOS
    At this time, we did not consider alternatives as this is existing 
policy that is being codified with additional leniencies based on prior 
experiences. We welcome the submission of comments.
8. Provider Enrollment Provisions
    We considered several alternatives for addressing our provider 
enrollment-related concerns regarding hospice program integrity and 
quality of care. We concluded that moving hospices to the high-risk 
screening category and expanding Sec.  424.550(b) to include hospices 
were the most appropriate provider enrollment regulatory means of 
addressing these issues.

F. Accounting Statements and Tables

1. HH PPS
    As required by OMB Circular A-4 (available at https://www.whitehouse.gov/wp-content/uploads/legacy_drupal_files/omb/circulars/A4/a-4.pdf, in Table GG 8, we have prepared an accounting 
statement showing the classification of the transfers and benefits 
associated with the CY 2024 HH PPS provisions of this rule.
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2. HH QRP
    As required by OMB Circular A-4 (available at https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/circulars/A4/a-4.pdf), in Table GG 9, we have prepared an accounting statement showing 
the classification of the expenditures associated with this final rule 
as they relate to HHAs. Table GG 9 provides our best estimate of the 
increase in burden for OASIS submission.
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[[Page 43809]]


3. Expanded HHVBP Model
    As required by OMB Circular A-4 (available at https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/circulars/A4/a-4.pdf), in Table GG 10 we have prepared an accounting statement. Table 
GG 10 provides our best estimate of the decrease in Medicare payments 
under the expanded HHVBP Model.
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4. Home IVIG Items and Services
    As required by OMB Circular A-4 (available at https://www.whitehouse.gov/wp-content/uploads/legacy_drupal_files/omb/circulars/A4/a-4.pdf, in Table GG 11, we have prepared an accounting 
statement showing the classification of the transfers and benefits 
associated with the CY 2024 IVIG provisions of this rule.
[GRAPHIC] [TIFF OMITTED] TP10JY23.103

5. DMEPOS
a. Conforming Changes to Regulations To Codify Change Mandated by 
Section 4139 of the Consolidated Appropriations Act, 2023
    As required by OMB Circular A-4 (available at https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/circulars/A4/a-4.pdf), in Table GG 12, we have prepared an accounting statement 
showing the classification of the expenditures associated with this 
provision. Table GG 12 provides our best estimate of the transfers.
[GRAPHIC] [TIFF OMITTED] TP10JY23.104

b. Scope of the Benefit and Payment for Lymphedema Compression 
Treatment Items
    As required by OMB Circular A-4 (available at https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/circulars/A4/a-4.pdf), in Table GG 13, we have prepared an accounting statement 
showing the classification of the expenditures associated with this 
provision. Table GG 13 provides our best estimate of the transfers.

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G. Regulatory Flexibility Act (RFA)

    The RFA requires agencies to analyze options for regulatory relief 
of small entities, if a rule has a significant impact on a substantial 
number of small entities. For purposes of the RFA, small entities 
include small businesses, nonprofit organizations, and small 
governmental jurisdictions. In addition, HHAs are small entities, as 
that is the term used in the RFA. Individuals and States are not 
included in the definition of a small entity.
    The NAICS was adopted in 1997 and is the current standard used by 
the Federal statistical agencies related to the U.S. business economy. 
We utilized the NAICS U.S. industry title ``Home Health Care Services'' 
and corresponding NAICS code 621610 in determining impacts for small 
entities. The NAICS code 621610 has a size standard of $19 million 
\222\ and approximately 96 percent of HHAs are considered small 
entities. Table GG 14 shows the number of firms, revenue, and estimated 
impact per home health care service category.
---------------------------------------------------------------------------

    \222\ https://www.sba.gov/sites/sbagov/files/2023-03/Table%20of%20Size%20Standards_Effective%20March%2017%2C%202023.xlsx.
[GRAPHIC] [TIFF OMITTED] TP10JY23.106

    The economic impact assessment is based on estimated Medicare 
payments (revenues) and HHS's practice in interpreting the RFA is to 
consider effects economically ``significant'' only if greater than 5 
percent of providers reach a threshold of 3 to 5 percent or more of 
total revenue or total costs. The majority of HHAs' visits are Medicare 
paid visits and therefore the majority of HHAs' revenue consists of 
Medicare payments. Based on our analysis, we conclude that the policies 
finalized in this rule would result in an estimated total impact of 3 
to 5 percent or more on Medicare revenue for greater than 5 percent of 
HHAs. Therefore, the Secretary has determined that this HH PPS final 
rule will have significant economic impact on a substantial number of 
small entities. We estimate that the net impact of the policies in this 
rule is approximately $375 million in decreased payments to HHAs in CY 
2024. The $375 million in decreased payments are reflected in the last 
column of the first row in Table GG 14

[[Page 43811]]

as a 2.2 percent decrease in expenditures when comparing CY 2024 
payments to estimated CY 2023 payments. The 2.2 percent decrease is 
mostly driven by the impact of the permanent behavior assumption 
adjustment reflected in the third column of Table GG 1. Further detail 
is presented in Table GG 1, by HHA type and location.
    With regards to options for regulatory relief, we note that section 
1895(b)(3)(D)(i) of the Act requires CMS to annually determine the 
impact of differences between the assumed behavior changes finalized in 
the CY 2019 HH PPS final rule with comment period (83 FR 56455) and 
actual behavior changes on estimated aggregate expenditures under the 
HH PPS with respect to years beginning with 2020 and ending with 2026. 
Additionally, section 1895(b)(3)(D)(ii) and (iii) of the Act requires 
us to make permanent and temporary adjustments to the payment rate to 
offset for such increases or decreases in estimated aggregate 
expenditures through notice and comment rulemaking. While we find that 
the -5.653 percent permanent payment adjustment, described in section 
II.C.1.g. of this proposed rule, is necessary to offset the increase in 
estimated aggregate expenditures for CYs 2020 through 2022 based on the 
impact of the differences between assumed behavior changes and actual 
behavior changes, we will also continue to reprice claims, per the 
finalized methodology, and make any additional adjustments at a time 
and manner deemed appropriate in future rulemaking. As discussed 
previously, we also explored alternatives to the proposed -5.653 
percent permanent payment adjustment including a phase-in approach, 
where we could reduce the permanent adjustment, by spreading out the CY 
2024 permanent adjustment over a period of years. Another alternative 
would be to delay the permanent adjustment to a future year. However, 
we believe that a reduction to the permanent adjustment, a phase-in 
approach, or delay in the permanent adjustment would not be 
appropriate, as reducing, phasing in, or delaying the permanent 
adjustment would further impact budget neutrality and likely lead to a 
compounding effect creating the need for a larger reduction to the 
payment rate in future years. We also considered proposing to implement 
the one-time temporary adjustment to reconcile retrospective 
overpayments in CYs 2020, 2021, and 2022. However, as stated previously 
in this rule, we recognize that applying the full permanent and 
temporary adjustments to the CY 2024 payment rate may adversely affect 
HHAs, including small entities. We are soliciting comments on the 
overall HH PPS RFA analysis.
    Guidance issued by HHS interpreting the Regulatory Flexibility Act 
considers the effects economically `significant' only if greater than 5 
percent of providers reach a threshold of 3 to 5 percent or more of 
total revenue or total costs. Among the over 7,500 HHAs that are 
estimated to qualify to compete in the expanded HHVBP Model, we 
estimate that the percent payment adjustment resulting from this rule 
would be larger than 3 percent, in magnitude, for about 28 percent of 
competing HHAs (estimated by applying the proposed 5-percent maximum 
payment adjustment under the expanded Model to CY 2019 data). As a 
result, more than the RFA threshold of 5-percent of HHA providers 
nationally would be significantly impacted. We refer readers to Tables 
43 and 44 in the CY 2022 HH PPS final rule (86 FR 62407 through 62410) 
for our analysis of payment adjustment distributions by State, HHA 
characteristics, HHA size, and percentiles.
    Thus, the Secretary has certified that this final rule would have a 
significant economic impact on a substantial number of small entities. 
Though the RFA requires consideration of alternatives to avoid economic 
impacts on small entities, the intent of the rule, itself, is to 
encourage quality improvement by HHAs through the use of economic 
incentives. As a result, alternatives to mitigate the payment 
reductions would be contrary to the intent of the rule, which is to 
test the effect on quality and costs of care of applying payment 
adjustments based on HHAs' performance on quality measures.
    In addition, section 1102(b) of the Act requires us to prepare an 
RIA if a rule may have a significant impact on the operations of a 
substantial number of small rural hospitals. This analysis must conform 
to the provisions of section 603 of RFA. For purposes of section 
1102(b) of the Act, we define a small rural hospital as a hospital that 
is located outside of a metropolitan statistical area and has fewer 
than 100 beds. This rule is not applicable to hospitals. Therefore, the 
Secretary has certified that this proposed rule would not have a 
significant economic impact on the operations of small rural hospitals.

H. Unfunded Mandates Reform Act (UMRA)

    Section 202 of UMRA of 1995 UMRA also requires that agencies assess 
anticipated costs and benefits before issuing any rule whose mandates 
require spending in any 1 year of $100 million in 1995 dollars, updated 
annually for inflation. In 2023, that threshold is approximately $177 
million. This proposed rule would not impose a mandate that will result 
in the expenditure by State, local, and Tribal Governments, in the 
aggregate, or by the private sector, of more than $177 million in any 
one year.

I. Federalism

    Executive Order 13132 establishes certain requirements that an 
agency must meet when it promulgates a proposed rule (and subsequent 
final rule) that imposes substantial direct requirement costs on State 
and local governments, preempts State law, or otherwise has Federalism 
implications. We have reviewed this final rule under these criteria of 
Executive Order 13132 and have determined that it would not impose 
substantial direct costs on State or local governments.

J. Conclusion

    In conclusion, we estimate that the provisions in this proposed 
rule will result in an estimated net decrease in home health payments 
of 2.2 percent for CY 2024 (-$375 million). The $375 million decrease 
in estimated payments for CY 2024 reflects the effects of the CY 2024 
home health payment update percentage increase of 2.7 percent ($460 
million increase), a 0.2 percent increase in payments due to the new 
lower FDL ratio, which will increase outlier payments in order to 
target to pay no more than 2.5 percent of total payments as outlier 
payments ($35 million increase) and an estimated 5.1 percent decrease 
in payments that reflects the effects of the permanent behavior 
adjustment ($870 million decrease).
    Chiquita Brooks-LaSure, Administrator of the Centers for Medicare & 
Medicaid Services, approved this document on June 26, 2023.

List of Subjects

42 CFR Part 409

    Health facilities, Medicare.

42 CFR Part 410

    Diseases, Health facilities, Health professions, Laboratories, 
Medicare, Reporting and recordkeeping requirements, Rural areas, X-
rays.

42 CFR Part 414

    Administrative practice and procedure, Health facilities, Health 
professions, Kidney diseases, Medicare,

[[Page 43812]]

Reporting and recordkeeping requirements.

42 CFR Part 424

    Emergency medical services, Health facilities, Health professions, 
Medicare, Reporting and recordkeeping requirements.

42 CFR Part 484

    Administrative practice and procedure, Grant programs-health, 
Health facilities, Health professions, Home health care, Medicare, 
Reporting and recordkeeping requirements.

42 CFR Part 488

    Administrative practice and procedure, Health facilities, Health 
professions, Medicare, Reporting and recordkeeping requirements.

42 CFR Part 489

    Health facilities, Medicare, Reporting and recordkeeping 
requirements.

    For the reasons stated in the preamble, the Centers for Medicare & 
Medicaid Services proposes to amend 42 CFR Chapter IV as follows:

PART 409--HOSPITAL INSURANCE BENEFITS

0
1. The authority citation for part 409 continues to read as follows:

    Authority: 42 U.S.C. 1302 and 1395hh.


Sec.  409.50  [Amended]

0
2. In Sec.  409.50 amend paragraph (b) by removing the phrase ``for 
furnishing the Negative Pressure Wound Therapy (NPWT) using a 
disposable device'' and adding in its place the phrase ``for the 
disposable Negative Pressure Wound Therapy (NPWT) device''.

PART 410--SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS

0
3. The authority citation for part 410 continues to read as follows:

    Authority: 42 U.S.C. 1302, 1395m, 1395hh, 1395rr, and 1395ddd.

0
4. Amend Sec.  410.2 by adding the definitions of ``Brace'', ``Custom 
fitted gradient compression garment'', ``gradient compression'', and 
``lymphedema compression treatment item'' in alphabetical order to read 
as follows:


Sec.  410.2  Definitions

* * * * *
    Brace means a rigid or semi-rigid device used for the purpose of 
supporting a weak or deformed body member or restricting or eliminating 
motion in a diseased or injured part of the body.
* * * * *
    Custom fitted gradient compression garment means a garment that is 
uniquely sized and shaped to fit the exact dimensions of the affected 
extremity or part of the body, of an individual to provide accurate 
gradient compression to treat lymphedema.
* * * * *
    Gradient compression means the ability to apply a higher level of 
compression or pressure to the distal (farther) end of the limb or body 
part affected by lymphedema with lower, decreasing compression or 
pressure at the proximal (closer) end of the limb or body part affected 
by lymphedema.
    Lymphedema compression treatment item means standard and custom 
fitted gradient compression garments and other items specified under 
Sec.  410.36(a)(4) that are--
    (1) Furnished on or after January 1, 2024, to an individual with a 
diagnosis of lymphedema for treatment of such condition;
    (2) Primarily and customarily used to serve a medical purpose and 
for the treatment of lymphedema; and
    (3) Prescribed by a physician (or a physician assistant, nurse 
practitioner, or a clinical nurse specialist (as those terms are 
defined in section 1861(aa)(5) of the Act) to the extent authorized 
under State law.
* * * * *


Sec.  410.10  [Amended]

0
5. In Sec.  410.10 amend paragraph (y) by removing the phrase 
``globulin administered'' and adding in its place the phrase 
``globulin, including items and services, administered''.
0
6. Amend Sec.  410.36 by revising paragraph (a)(3) and adding paragraph 
(a)(4) to read as follows:


Sec.  410.36  Medical supplies, appliances, and devices: Scope.

* * * * *
    (a) * * *
    (3)(i) Leg, arm, back, and neck braces.
    (A) A leg brace may include a shoe if it is an integral part of the 
brace (necessary for the leg brace to function properly) and its 
expense is included as part of the cost of the brace.
    (ii) Artificial legs, arms, and eyes; and
    (iii) Replacements for the devices specified in paragraphs 
(a)(3)(i) and (ii) if required because of a change in the individual's 
physical condition.
    (4) Lymphedema compression treatment items, including the 
following:
    (i) Standard and custom fitted gradient compression garments.
    (ii) Gradient compression wraps with adjustable straps.
    (iii) Compression bandaging systems.
    (iv) Other items determined to be lymphedema compression treatment 
items under the process established under Sec.  414.1670.
    (v) For the purposes of paragraphs (i) and (ii) of this paragraph, 
the scope of the benefit for lymphedema compression treatment items 
includes accessories such as zippers in garments, liners worn under 
garments or wraps with adjustable straps, and padding or fillers that 
are necessary for the effective use of a gradient compression garment 
or wrap with adjustable straps.
* * * * *
0
7. Section 410.38 is amended by adding paragraph (d)(4) to read as 
follows:


Sec.  410.38  Durable medical equipment, prosthetics, orthotics and 
supplies (DMEPOS): Scope and conditions.

* * * * *
    (d) * * *
    (4) Refills--(i) Definitions. As used in this paragraph (d):
    Date of service (for refilled items) means either--
    (1) The date of delivery for the DMEPOS item; or
    (2) For items rendered via delivery or shipping service, the 
shipping date.
    Refills mean DMEPOS products that are provided on a recurring basis 
secondary to a medically necessary DMEPOS order.
    Shipping date means--
    (1) The date the delivery/shipping service label is created; or
    (2) The date that the item is retrieved for delivery. These dates 
must not demonstrate significant variation.
    (ii) Documentation. The DMEPOS supplier must document contact with 
the beneficiary or their representative to verify the refill is needed. 
This documentation must include both of the following:
    (A) Evidence of the beneficiary or their representative's 
affirmative response of the need for supplies, which should be obtained 
as close to the expected end of the current supply as possible. Contact 
and affirmative response must be within 30 calendar days from the 
expected end of the current supply.
    (B)(1) For shipped items, the beneficiary name, date of contact, 
the item requested, and an affirmative response from the beneficiary, 
indicative of the need for refill, prior to dispensing the product; or
    (2) For items obtained in-person from a retail store, the delivery 
slip signed by the beneficiary or their representative or

[[Page 43813]]

a copy of the itemized sales receipt is sufficient documentation of a 
request for refill.
    (iii) Delivery of DMEPOS items provided on a recurring basis. The 
date of service for DMEPOS items provided on a recurring basis must be 
no earlier than 10 calendar days before the expected end of the current 
supply.
* * * * *

PART 414--PAYMENT FOR PART B MEDICAL AND OTHER HEALTH SERVICES

0
8. The authority citation for part 414 continues to read as follows:

    Authority: 42 U.S.C. 1302, 1395hh, and 1395rr(b)(l).

0
9. Section 414.210 is amended by--
0
a. In paragraph (g)(2)(ii) introductory text, removing the phrase ``(42 
U.S.C. 1320b-5(g)(1)(B)), whichever is later'' and adding in its place 
the phrase ``(42 U.S.C. 1320b-5(g)(1)(B)), or December 31, 2023, 
whichever is later'';
0
b. In paragraph (g)(2)(iii) introductory text, removing the phrase 
``(42 U.S.C. 1320b-5(g)(1)(B)), whichever is later'' and adding in its 
place the phrase ``(42 U.S.C. 1320b-5(g)(1)(B)), or December 31, 2023, 
whichever is later'';
0
c. In paragraph (g)(9)(iii) removing the phrase ``from June 1, 2018 
through December 31, 2020 or through the duration'' and adding in its 
place the phrase ``from June 1, 2018 through the duration of the 
emergency period described in section 1135(g)(1)(B) of the Act (42 
U.S.C. 1320b-5(g)(1)(B)) or December 31, 2023'';
0
d. Revising paragraph (g)(9)(v); and
0
e. In paragraph (g)(9)(vi), removing the date ``February 28, 2022'' and 
adding in its place the date ``January 1, 2024''.
    The revision reads as follows:


Sec.  414.210  General payment rules.

* * * * *
    (g) * * *
    (9) * * *
    (v) For items and services furnished in areas other than rural or 
noncontiguous areas with dates of service from March 6, 2020, through 
the remainder of the duration of the emergency period described in 
section 1135(g)(1)(B) of the Act (42 U.S.C. 1320b-5(g)(1)(B)) or 
December 31, 2023, whichever is later, based on the fee schedule amount 
for the area is equal to 75 percent of the adjusted payment amount 
established under this section and 25 percent of the unadjusted fee 
schedule amount.
* * * * *
0
10. Amend Sec.  414.402 by revising the definition of ``Item'' to read 
as follows:


Sec.  414.402  Definitions.

* * * * *
    Item means a product included in a competitive bidding program that 
is identified by a HCPCS code, which may be specified for competitive 
bidding (for example, a product when it is furnished through mail 
order), or a combination of codes with or without modifiers, and 
includes the services directly related to the furnishing of that 
product to the beneficiary. Items that may be included in a competitive 
bidding program are as follows:
    (1) DME other than class III devices under the Federal Food, Drug 
and Cosmetic Act, as defined in Sec.  414.402, group 3 complex 
rehabilitative power wheelchairs, complex rehabilitative manual 
wheelchairs, manual wheelchairs described by HCPCS codes E1235, E1236, 
E1237, E1238, and K0008, and related accessories when furnished in 
connection with such wheelchairs, and further classified into the 
following categories:
    (i) Inexpensive or routinely purchased items, as specified in Sec.  
414.220(a).
    (ii) Items requiring frequent and substantial servicing, as 
specified in Sec.  414.222(a).
    (iii) Oxygen and oxygen equipment, as specified in Sec.  
414.226(c)(1).
    (iv) Other DME (capped rental items), as specified in Sec.  
414.229.
    (2) Supplies necessary for the effective use of DME other than 
inhalation and infusion drugs.
    (3) Enteral nutrients, equipment, and supplies.
    (4) Off-the-shelf orthotics, which are orthotics described in 
section 1861(s)(9) of the Act that require minimal self-adjustment for 
appropriate use and do not require expertise in trimming, bending, 
molding, assembling or customizing to fit a beneficiary.
    (5) Lymphedema compression treatment items.
* * * * *
0
11. Amend Sec.  414.408 by adding paragraph (g)(5) to read as follows:


Sec.  414.408  Payment rules.

* * * * *
    (g) * * *
    (5) Lymphedema compression treatment items.
* * * * *
0
12. Amend Sec.  414.412 by revising paragraph (b)(2) to read as 
follows:


Sec.  414.412  Submission of bids under a competitive bidding program.

* * * * *
    (b) * * *
    (2) The bid submitted for each lead item and product category 
cannot exceed the payment amount that would otherwise apply to the lead 
item under--
    (i) Subpart C of this part, without the application of Sec.  
414.210(g);
    (ii) Subpart D of this part, without the application of Sec.  
414.105; or
    (iii) Subpart Q of this part, without the application of Sec.  
414.1690.
* * * * *
0
13. Add subpart Q, consisting of Sec. Sec.  414.1600 through 414.1690, 
to read as follows:
Subpart Q--Payment for Lymphedema Compression Treatment Items
Sec.
414.1600 Purpose and definitions.
414.1650 Payment basis for lymphedema compression treatment items.
414.1660 Continuity of pricing when HCPCS codes are divided or 
combined.
414.1670 Procedures for making benefit category determinations and 
payment determinations for new lymphedema compression treatment 
items.
414.1680 Frequency limitations.
414.1690 Application of competitive bidding information.

Subpart Q--Payment for Lymphedema Compression Treatment Items


Sec.  414.1600  Purpose and definitions.

    (a) Purpose. This subpart implements section 1834(z) of the Act and 
establishes procedures for making benefit category determinations and 
payment determinations for lymphedema compression treatment items.
    (b) Definitions. For purposes of this subpart the following 
definitions apply:
    Benefit category determination means a national determination 
regarding whether an item or service meets the Medicare definition of 
lymphedema compression treatment item at section 1861(mmm) of the Act 
and the rules of this subpart and is not otherwise excluded from 
coverage by statute.
    Lymphedema compression treatment item means an item as described in 
Sec.  410.2.


Sec.  414.1650  Payment basis for lymphedema compression treatment 
items.

    (a) General payment rule. For items furnished on or after January 
1, 2024, Medicare pays for lymphedema compression treatment items on 
the basis of 80 percent of the lesser of -
    (1) The actual charge for the item; or
    (2) The payment amount for the item, as determined in accordance 
with paragraph (b) of this section.
    (b) Payment amounts. The payment amounts for covered lymphedema 
compression treatment items paid for under this subpart are established 
based on one of the following:
    (1) If payment amounts are available from Medicaid state plans, 
then 120

[[Page 43814]]

percent of the average of the Medicaid payment amounts.
    (2) If payment amounts are not available from Medicaid state plans, 
then 100 percent of the average of average internet retail prices and 
payment amounts from TRICARE (Department of Defense).
    (3) If payment amounts are not available from Medicaid state plans 
or TRICARE, then 100 percent of average internet retail prices.
    (c) Updates to payment amounts. The payment amounts for covered 
lymphedema compression treatment items established in accordance with 
paragraph (b) of this section are increased on an annual basis 
beginning on January 1 of the year subsequent to the year in which the 
payment amounts are initially established based on the percent change 
in the Consumer Price Index for all Urban Consumers (CPI-U) for the 12-
month period ending with June of the previous year.


Sec.  414.1660  Continuity of pricing when HCPCS codes are divided or 
combined.

    (a) General rule. If HCPCS codes for lymphedema compression 
treatment items are divided or combined, the payment amounts for the 
old codes are mapped to the new codes to ensure continuity of pricing.
    (b) Mapping of payment amounts. (1) If there is a single code that 
describes two or more distinct complete items (for example, two 
different but related or similar items), and separate codes are 
subsequently established for each item, then the payment amounts that 
applied to the single code continue to apply to each of the items 
described by the new codes.
    (2) If the codes for several different items are combined into a 
single code, then the payment amounts for the new code are established 
using the average (arithmetic mean), weighted by allowed services, of 
the payment amounts for the formerly separate codes.


Sec.  414.1670  Procedures for making benefit category determinations 
and payment determinations for new lymphedema compression treatment 
items.

    The procedures for determining whether new items and services 
addressed in a request for a HCPCS Level II code(s) or by other means 
meet the definition of items and services paid for in accordance with 
this subpart are as follows:
    (a) At the start of a HCPCS coding cycle, CMS performs an analysis 
to determine if the item is statutorily excluded from coverage under 
Medicare under section 1862 of the Act.
    (1) If not excluded by statute, then CMS determines whether the 
item is a lymphedema compression treatment item as defined under 
section 1861(mmm) of the Act.
    (2) If excluded by statute, the analysis is concluded.
    (b) If a preliminary determination is made that the item is a 
lymphedema compression treatment item, CMS makes a preliminary payment 
determination for the item or service.
    (c) CMS posts preliminary benefit category determinations and 
payment determinations on CMS.gov approximately 2 weeks prior to a 
public meeting.
    (d) After consideration of public consultation provided at a public 
meeting on preliminary benefit category determinations and payment 
determinations for items, CMS establishes the benefit category 
determinations and payment determinations for items through program 
instructions.


Sec.  414.1680  Frequency limitations.

    (a) General rule. With the exception of replacements of items that 
are lost, stolen, or irreparably damaged, or if needed due to a change 
in the patient's medical or physical condition, no payment may be made 
for gradient compression garments or wraps with adjustable straps 
furnished other than at the frequencies established in paragraphs (b) 
and (c) of this section.
    (b) Initial furnishing of lymphedema compression treatment items. 
The following frequency limitations apply to items initially furnished 
to the beneficiary if determined to be reasonable and necessary for the 
treatment of lymphedema:
    (1) Two units of daytime gradient compression garments or wraps 
with adjustable straps per affected extremity or part of the body.
    (2) One garment for nighttime use per affected extremity or part of 
the body.
    (c) Replacements of lymphedema compression treatment items. The 
following frequency limitations apply to replacements of lymphedema 
compression treatment items if determined to be reasonable and 
necessary for the treatment of lymphedema:
    (1) Payment for the replacement of gradient compression garments or 
wraps with adjustable straps per each affected extremity or part of the 
body can be made once every 6 months.
    (2) Payment for the replacement of nighttime garments per each 
affected extremity or part of the body can be made once a year.
    (d) Replacements of lymphedema compression bandaging systems or 
supplies. Specific frequency limitations are not established for these 
items. Determinations regarding the quantity of compression bandaging 
supplies needed by each beneficiary during phase one of decongestive 
therapy are made by the DME MAC that processes the claims for the 
supplies.


Sec.  414.1690  Application of competitive bidding information.

    The payment amounts for lymphedema compression treatment items 
under Sec.  414.1650(b) may be adjusted using information on the 
payment determined as part of implementation of the programs under 
subpart F using the methodologies set forth at Sec.  414.210(g).
0
14. Add subpart R, consisting of Sec.  141.1700, to read as follows:

Subpart R--Home Intravenous Immunoglobulin (IVIG) Items and 
Services Payment


Sec.  414.1700  Basis of payment.

    (a) General rule. For home intravenous immunoglobulin (IVIG) items 
or services furnished on or after January 1, 2024, Medicare payment is 
made on the basis of 80 percent of the lesser of the following:
    (1) The actual charge for the item or service.
    (2) The fee schedule amount for the items and services, as 
determined in accordance with the provisions of this section.
    (b) Per visit amount. A single payment amount is made for items and 
services furnished by a DME supplier per visit.
    (c) Initial establishment of the payment amount. In establishing 
the initial per visit IVIG items and services payment amount for CY 
2024, CMS used the CY 2023 bundled payment rate under the IVIG 
Demonstration updated by the home health payment percentage update for 
CY 2024.
    (d) Annual payment adjustment. The per visit payment amount 
represents payment in full for all costs associated with the furnishing 
of home IVIG items and services and is subject to the following 
adjustment:
    (1) Beginning in 2025, an annual increase in the per-visit payment 
amount from the prior year by the home health update percentage 
increase for the current calendar year.
    (2) [Reserved]

PART 424--CONDITIONS FOR MEDICARE PAYMENT

0
15. The authority for part 424 continues to read as follows:

    Authority: 42 U.S.C. 1302 and 1395hh.

[[Page 43815]]

Subpart P--Requirements for Establishing and Maintaining Medicare 
Billing Privileges

0
16. Further amend Sec.  424.502 (as proposed to be amended at 88 FR 
9829, February 15, 2023) by--
0
a. In the definition of ``Change in majority ownership'' removing the 
term ``HHA'' and in its place the phrase ``HHA or hospice'' wherever it 
appears.
0
b. Revising paragraph (1) of the proposed definition of ``Managing 
employee''.
    The revision reads as follows:


Sec.  424.502  Definitions.

* * * * *
    Managing employee means--(1) A general manager, business manager, 
administrator, director, or other individual that exercises operational 
or managerial control over, or who directly or indirectly conducts, the 
day-to-day operation of the provider or supplier, either under contract 
or through some other arrangement, whether or not the individual is a 
W-2 employee of the provider or supplier. For purposes of this 
definition, this includes a hospice or skilled nursing facility 
administrator and a hospice or skilled nursing facility medical 
director.
* * * * *
0
17. Amend Sec.  424.518 by--
0
a. Removing paragraph (b)(1)(iv);
0
b. Redesignating paragraphs (b)(1)(v) through (b)(1)(viii) as 
paragraphs (b)(1)(iv) through (b)(1)(vii);
0
c. Redesignating paragraph (b)(1)(xii) as paragraph (b(1)(viii);
0
d. Revising newly redesignated paragraph (b)(1)(viii) and paragraph 
(b)(1)(ix);
0
e. Removing paragraphs (b)(1)(x) through (b)(1)(xiv);
0
f. Revising (c)(1)(vi); and
0
g. Adding paragraphs (c)(1)(vii) and (viii).
    The revisions and additions read as follows:


Sec.  424.518  Screening levels for Medicare providers and suppliers.

* * * * *
    (b) * * *
    (1) * * *
    (viii) Prospective (newly enrolling) and revalidating opioid 
treatment programs that have been fully and continuously certified by 
the Substance Abuse and Mental Health Services Administration (SAMHSA) 
since October 23, 2018.
    (ix) Revalidating opioid treatment programs that have not been 
fully and continuously certified by SAMHSA since October 23, 2018, 
revalidating DMEPOS suppliers, revalidating MDPP suppliers, 
revalidating HHAs, revalidating SNFs, and revalidating hospices to 
which CMS applied the fingerprinting requirements outlined in paragraph 
(c)(2)(ii) of this section upon the provider's or supplier's--
    (A) New/initial enrollment; or
    (B) Revalidation after CMS waived the fingerprinting requirements, 
under the circumstances described in paragraph (c)(1)(viii) of this 
section, when the provider or supplier initially enrolled in Medicare.
* * * * *
    (c) * * *
    (1) * * *
    (vi) Prospective (newly enrolling) hospices.
    (vii) Enrolled opioid treatment programs that have not been fully 
and continuously certified by SAMHSA since October 23, 2018, DMEPOS 
suppliers, MDPP suppliers, HHAs, SNFs, and hospices that are submitting 
a change of ownership application under 42 CFR 489.18 or reporting any 
new owner (regardless of ownership percentage) in accordance with a 
change of information or other enrollment transaction under title 42.
    (viii) Except as stated in paragraph (b)(1)(ix) of this section, 
revalidating opioid treatment programs that have not been fully and 
continuously certified by SAMHSA since October 23, 2018, revalidating 
DMEPOS suppliers, revalidating MDPP suppliers, revalidating HHAs, 
revalidating SNFs, and revalidating hospices for which, upon their new/
initial enrollment, CMS waived the fingerprinting requirements outlined 
in paragraph (c)(2)(ii) of this section in accordance with applicable 
legal authority due to a national, state, or local emergency declared 
under existing law.
* * * * *
0
18. Add Sec.  424.527 to read as follows:


Sec.  424.527  Provisional period of oversight.

    (a) New provider or supplier. Exclusively for purposes of both 
section 1866(j)(3) of the Act and this Sec.  424.527, the term ``new 
provider or supplier'' is defined as any of the following:
    (1) A newly enrolling Medicare provider or supplier. (This includes 
providers that are required to enroll as a new provider in accordance 
with the change in majority ownership provisions in Sec.  424.550(b).)
    (2) A certified provider or certified supplier undergoing a change 
of ownership consistent with the principles of 42 CFR 489.18. (This 
includes providers that qualify under Sec.  424.550(b)(2) for an 
exception from the change in majority ownership requirements in Sec.  
424.550(b)(1) but which are undergoing a change of ownership under 42 
CFR 489.18).
    (3) A provider or supplier (including an HHA or hospice) undergoing 
a 100 percent change of ownership via a change of information request 
under Sec.  424.516.
    (b) Effective date. The effective date of a provisional period of 
enhanced oversight that is commenced under section 1866(j)(3) of the 
Act is the date on which the new provider or supplier submits its first 
claim.
0
19. Amend Sec.  424.530 by--
0
a. In paragraph (f) introductory text removing the phrase ``3 years'' 
and adding in its place ``10 years''.
0
b. Adding paragraph (f)(3).
    The revision and additions read as follows:


Sec.  424.530  Denial of enrollment in the Medicare program.

* * * * *
    (f) * * *
    (3)(i) A provider or supplier that is currently subject to a 
reapplication bar under paragraph (f) of this section may not order, 
refer, certify, or prescribe Medicare-covered services, items, or 
drugs.
    (ii) Medicare does not pay for any otherwise covered service, item, 
or drug that is ordered, referred, certified, or prescribed by a 
provider or supplier that is currently under a reapplication bar.
0
20. Section 424.540(a)(1) is amended by removing the number ``12'' and 
adding in its place the number ``6'' wherever it appears.
0
21 Add Sec.  424.542 to read as follows:


Sec.  424.542  Prohibition on ordering, certifying, referring, or 
prescribing based on felony conviction.

    (a) General prohibition. A physician or other eligible professional 
(regardless of whether he or she is or was enrolled in Medicare) who 
has had a felony conviction within the previous 10 years that CMS 
determines is detrimental to the best interests of the Medicare program 
and its beneficiaries may not order, refer, certify, or prescribe 
Medicare-covered services, items, or drugs.
    (b) Payment. Medicare does not pay for any otherwise covered 
service, item, or drug that is ordered, referred, certified, or 
prescribed by a physician or other eligible professional (as that term 
is defined in section 1848(k)(3)(B) of the Act) who has had a felony 
conviction within the previous 10 years that CMS determines is 
detrimental to the best interests of the Medicare program and its 
beneficiaries.
0
22. Amend Sec.  424.550 by--

[[Page 43816]]

0
a. Revising paragraph (b)(1) introductory text;
0
b. In paragraph (b)(1)(i) removing the term ``HHA'' and adding in its 
place the phrase ``HHA or hospice'';
0
c. In paragraph (b)(2)(i) removing the phrase ``The HHA submitted two 
consecutive years'' and adding in its place the phrase ``The HHA or 
hospice submitted 2 consecutive years'';
0
d. In paragraph (b)(2)(ii), removing the term ``HHA's'' and adding in 
its place the phrase ``HHA's or hospice's'';
0
e. In paragraph (b)(2)(iii), removing the phrase ``The owners of an 
existing HHA are changing the HHA's'' and adding in its place the 
phrase ``The owners of an existing HHA or hospice are changing the 
HHA's or hospice's'';
0
f. In paragraph (b)(2)(iv) removing the term ``HHA'' and adding in its 
place the phrase ``HHA or hospice''.
    The revision reads as follows:


Sec.  424.550  Prohibitions on the sale or transfer of billing 
privileges.

* * * * *
    (b) * * *
    (1) Unless an exception in paragraph (b)(2) of this section 
applies, if there is a change in majority ownership of a home health 
agency (HHA) or hospice by sale (including asset sales, stock 
transfers, mergers, and consolidations) within 36 months after the 
effective date of the HHA's or hospice's initial enrollment in Medicare 
or within 36 months after the HHA's or hospice's most recent change in 
majority ownership, the provider agreement and Medicare billing 
privileges do not convey to the new owner. The prospective provider/
owner of the HHA or hospice must instead do both of the following:
* * * * *

PART 484--HOME HEALTH SERVICES

0
23. The authority citation for part 484 continues to read as follows:

    Authority: 42 U.S.C. 1302 and 1395hh.

0
24. Section 484.202 is amended by revising the definition of 
``Furnishing Negative Pressure Wound Therapy (NPWT) using a disposable 
device'' to read as follows:


Sec.  484.202  Definitions.

* * * * *
    Furnishing Negative Pressure Wound Therapy (NPWT) using a 
disposable device means the device is paid separately (specified by the 
assigned CPT[supreg] code) and does not include payment for the 
professional services. The nursing and therapy services are to be 
included as part of the payment under the home health prospective 
payment system.
* * * * *
0
25. Section 484.245 is amended by redesignating paragraph (b)(2) as 
paragraph (b)(2)(i) and adding paragraph (b)(2)(ii) to read as follows:


Sec.  484.245  Data submission requirements under the home health 
quality reporting program.

* * * * *
    (b) * * *
    (2) * * *
    (ii) Data completion thresholds. (A) A home health agency must meet 
or exceed the data submission threshold set at 90 percent of all 
required OASIS or successor instrument records within 30-days of the 
beneficiary's admission or discharge and submitted through the CMS 
designated data submission systems.
    (B) A home health agency must meet or exceed the data submission 
compliance threshold described in paragraph (b)(2)(ii)(A) of this 
section to avoid receiving a 2-percentage point reduction to its annual 
payment update for a given fiscal year described under Sec.  
484.225(b).
* * * * *
0
26. Add Sec.  484.358 to read as follows:


Sec.  484.358  HHVBP Measure removal factors.

    CMS may remove a quality measure from the expanded HHVBP Model 
based on one or more of the following factors:
    (a) Measure performance among HHAs is so high and unvarying that 
meaningful distinctions in improvements in performance can no longer be 
made (that is, topped out).
    (b) Performance or improvement on a measure does not result in 
better patient outcomes.
    (c) A measure does not align with current clinical guidelines or 
practice.
    (d) A more broadly applicable measure (across settings, 
populations, or conditions) for the particular topic is available.
    (e) A measure that is more proximal in time to desired patient 
outcomes for the particular topic is available.
    (f) A measure that is more strongly associated with desired patient 
outcomes for the particular topic is available.
    (g) Collection or public reporting of a measure leads to negative 
unintended consequences other than patient harm.
    (h) The costs associated with a measure outweigh the benefit of its 
continued use in the program.
0
27. Amend Sec.  484.375 by revising paragraph (b)(5) to read as 
follows:


Sec.  484.375  Appeals process for the Expanded Home Health Value-Based 
Purchasing (HHVBP) Model.

* * * * *
    (b) * * *
    (5) Reconsideration decision. (i) CMS reconsideration officials 
issue a written decision that is final and binding upon issuance unless 
the CMS Administrator--
    (A) Renders a final determination reversing or modifying the 
reconsideration decision; or
    (B) Does not review the reconsideration decision within 14 days of 
the request.
    (ii) An HHA may request that the CMS Administrator review the 
reconsideration decision within 7 calendar days of the decision.
    (iii) If the CMS Administrator receives a request to review, the 
CMS Administrator must do one of the following:
    (A) Render a final determination based on his or her review of the 
reconsideration decision.
    (B) Decline to review a reconsideration decision made by CMS.
    (C) Choose to take no action.
    (iv) If the CMS Administrator does not review an HHA's request 
within 14 days (as described in paragraph (b)(5)(iii)(B) or (C) of this 
section), the reconsideration official's written reconsideration 
decision is final.

PART 488--SURVEY, CERTIFICATION, AND ENFORCEMENT PROCEDURES

0
28. The authority citation for part 488 continues to read as follows:

    Authority:  42 U.S.C. 1302 and 1395hh.

Subpart M--Survey and Certification of Hospice Programs

0
29. Amend Sec.  488.1105 by adding the definitions of ``Hospice Special 
Focus Program'', ``IDR'', ``SFP status'', and ``SFP survey'' in 
alphabetical order to read as follows:


Sec.  488.1105  Definitions.

* * * * *
    Hospice Special Focus Program (SFP) means a program conducted by 
CMS to identify hospices as poor performers, based on defined quality 
indicators, in which CMS selects hospices for increased oversight to 
ensure that they meet Medicare requirements. Selected hospices either 
successfully complete the SFP program or are terminated from the 
Medicare program.
    IDR stands for informal dispute resolution.
* * * * *
    SFP status means the status of a hospice provider in the SFP with

[[Page 43817]]

respect to the provider's progress in the SFP, which is indicated by 
one of the following status levels:
    (1) Level 1--in progress.
    (2) Level 2--completed successfully.
    (3) Level 3--terminated from the Medicare program.
    SFP survey means a standard survey as defined in this section that 
is applied after a hospice is selected for the SFP. The survey is 
conducted every 6 months, up to 3 occurrences.
* * * * *
0
30. Add Sec.  488.1130 to read as follows:


Sec.  488.1130  Informal dispute resolution (IDR).

    (a) Opportunity to refute survey findings. Upon the provider's 
receipt of an official statement of deficiencies, hospice programs can 
request an informal opportunity to dispute condition-level survey 
findings.
    (b) Failure to conduct IDR timely. Failure of CMS, the State, or 
the AO, as appropriate, to complete IDR must not delay the effective 
date of any enforcement action.
    (c) Revised statement of deficiencies as a result of IDR. If any 
findings are revised or removed by CMS, the State, or the AO based on 
IDR, the official statement of deficiencies is revised accordingly and 
any enforcement actions imposed solely as a result of those cited 
deficiencies are adjusted accordingly.
    (d) Notification. (1) If the survey findings indicate a condition-
level deficiency, the hospice program is notified in writing of its 
opportunity for participating in an IDR process at the time the 
official statement of deficiencies is issued.
    (2) The request for IDR must--
    (i) Be submitted in writing;
    (ii) Include the specific deficiencies that are disputed; and
    (iii) Be made within the same 10 calendar day period that the 
hospice program has for submitting an acceptable plan of correction.
0
31. Add Sec.  488.1135 to read as follows:


Sec.  488.1135  Hospice Special Focus Program (SFP).

    (a) Applicability. (1) The provisions of this section are effective 
on or after [the effective date of the final rule]; and
    (2) SFP selection begins in CY 2024.
    (b) Selection criteria. (1) Selection of hospices for the SFP is 
made based on the highest aggregate scores based on the algorithm used 
by CMS.
    (2) Hospice programs with accrediting organization deemed status 
placed in the SFP--
    (i) Do not retain deemed status; and
    (ii) Are placed under CMS or State survey agency jurisdiction until 
completion of the SFP or termination.
    (c) Survey and enforcement criteria. A hospice in the SFP--
    (1) Is surveyed not less than once every 6 months by CMS or the 
State agency; and
    (2) With condition level deficiencies on any survey is subject to 
standard enforcement actions and may be subject to progressive 
enforcement remedies at the discretion of CMS.
    (d) Completion criteria. A hospice in the SFP that has two SFP 
surveys within 18 months with no condition-level deficiencies, and that 
has no pending complaint survey triaged at an immediate jeopardy or 
condition level, or that has returned to substantial compliance with 
all requirements may complete the SFP.
    (e) Termination criteria. (1) A hospice in the SFP that does not 
meet the SFP completion requirements in paragraph (d) of this section 
is considered for termination from the Medicare program in accordance 
with 42 CFR 489.53.
    (2) CMS may consider termination from the Medicare program in 
accordance with Sec.  488.1225 if any survey results in an immediate 
jeopardy citation while the hospice is in the SFP.
    (f) Public reporting. CMS posts all of the following at least 
annually on a CMS public-facing website:
    (1) A subset of 10 percent of hospice programs based on the highest 
aggregate scores as determined by the algorithm used by CMS.
    (2) Hospice SFP selection from the list in paragraph (f)(1) of this 
section as determined by CMS.
    (3) SFP status as defined in Sec.  488.1105.

PART 489--PROVIDER AGREEMENTS AND SUPPLIER APPROVAL

0
32. The authority citation for part 489 continues to read as follows:

    Authority:  42 U.S.C. 1302, 1395i-3, 1395x, 1395aa(m), 1395cc, 
1395ff, and 1395(hh).

0
33. Section 489.52 is amended by adding paragraph (b)(4) to read as 
follows:


Sec.  489.52  Termination by the provider.

* * * * *
    (b) * * *
    (4) A provider may request a retroactive termination date if no 
Medicare beneficiary received services from the facility on or after 
the requested termination date.
* * * * *

    Dated: June 28, 2023.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2023-14044 Filed 6-30-23; 4:15 pm]
BILLING CODE 4120-01-P