Rule2023-24455

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

Primary source

Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.

Published
November 13, 2023
Effective
January 1, 2024

Issuing agencies

Health and Human Services DepartmentCenters for Medicare & Medicaid Services

Abstract

This final rule sets 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-- discusses comments received regarding access to home health aide services; implements home health payment-related changes; rebases and revises the home health market basket and revises the labor-related share; codifies statutory requirements for disposable negative pressure wound therapy (dNPWT); and implements the new items and services payment for the home intravenous immune globulin (IVIG) benefit. In addition, it--finalizes changes to the Home Health Quality Reporting Program (HH QRP) requirements and the expanded Home Health Value-Based Purchasing (HHVBP) Model; implements the new Part B benefit for lymphedema compression treatment items, codifies the Medicare definition of brace, and makes other codification changes based on recent legislation; adds an informal dispute resolution (IDR) and special focus program (SFP) for hospice programs; codifies DMEPOS refill policy; and finalizes proposed revisions for Medicare provider and supplier enrollment requirements.

Full Text

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<title>Federal Register, Volume 88 Issue 217 (Monday, November 13, 2023)</title>
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[Federal Register Volume 88, Number 217 (Monday, November 13, 2023)]
[Rules and Regulations]
[Pages 77676-77880]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-24455]



[[Page 77675]]

Vol. 88

Monday,

No. 217

November 13, 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; Final Rule

Federal Register / Vol. 88 , No. 217 / Monday, November 13, 2023 / 
Rules and Regulations

[[Page 77676]]


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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-F]
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: Final rule.

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SUMMARY: This final rule sets 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--
discusses comments received regarding access to home health aide 
services; implements home health payment-related changes; rebases and 
revises the home health market basket and revises the labor-related 
share; codifies statutory requirements for disposable negative pressure 
wound therapy (dNPWT); and implements the new items and services 
payment for the home intravenous immune globulin (IVIG) benefit. In 
addition, it--finalizes changes to the Home Health Quality Reporting 
Program (HH QRP) requirements and the expanded Home Health Value-Based 
Purchasing (HHVBP) Model; implements the new Part B benefit for 
lymphedema compression treatment items, codifies the Medicare 
definition of brace, and makes other codification changes based on 
recent legislation; adds an informal dispute resolution (IDR) and 
special focus program (SFP) for hospice programs; codifies DMEPOS 
refill policy; and finalizes proposed revisions for Medicare provider 
and supplier enrollment requirements.

DATES: These regulations are effective on January 1, 2024.

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 
<a href="/cdn-cgi/l/email-protection#652d0a08002d000409110d350a090c061c250608164b0d0d164b020a13"><span class="__cf_email__" data-cfemail="2b6344464e634e4a475f437b44474248526b48465805434358054c445d">[email&#160;protected]</span></a>.
    For information about the Home Health Quality Reporting Program (HH 
QRP), send your inquiry via email to <a href="/cdn-cgi/l/email-protection#753d3d24272504001006011c1a1b06351618065b1d1d065b121a03"><span class="__cf_email__" data-cfemail="e4acacb5b6b495918197908d8b8a97a4878997ca8c8c97ca838b92">[email&#160;protected]</span></a>
    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 
<a href="https://innovation.cms.gov/innovation-models/expanded-home-health-value-based-purchasing-model">https://innovation.cms.gov/innovation-models/expanded-home-health-value-based-purchasing-model</a>.
    For more information about the hospice informal dispute resolution 
and special focus program, send your inquiry to 
<a href="/cdn-cgi/l/email-protection#c79694888098afa8b4b7aea4a287a4aab4e9afafb4e9a0a8b1"><span class="__cf_email__" data-cfemail="0f5e5c40485067607c7f666c6a4f6c627c2167677c21686079">[email&#160;protected]</span></a>.

SUPPLEMENTARY INFORMATION: 

Table of Contents

I. Executive Summary and Issuance of the Proposed Rule
    A. Executive Summary
    B. Issuance of the Proposed Rule
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. 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. 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
    A. Background and Statutory Authority
    B. Proposed Regulatory Provisions
VII. Final Changes Regarding Durable Medical Equipment, Prosthetics, 
Orthotics, and Supplies (DMEPOS)
    A. Medicare Durable Medical Equipment, Prosthetics, Orthotics, 
and Supplies (DMEPOS) Fee Schedule Adjustments
    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. 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
    K. Waiver Fiscal Responsibility Act Requirements Regulations 
Text

I. Executive Summary and Issuance of the Proposed Rule

A. Executive Summary

1. Purpose and Legal Authority
a. Home Health Prospective Payment System (HH PPS)
    As required under section 1895(b) of the Social Security Act (the 
Act), this final rule updates the payment rates for home health 
agencies (HHAs) for CY 2024. In this final rule we discuss comments 
received on our request for information (RFI) related to access to home 
health aide services. This rule finalizes a permanent prospective 
adjustment to the CY 2024 home health payment rate to account for the 
differences between assumed and actual behavior changes on estimated 
aggregate expenditures. It also finalizes the proposal to recalibrate 
the PDGM case-

[[Page 77677]]

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 
that start in CY 2024. This rule finalizes the proposal to rebase and 
revise the home health market basket and finalizes the proposal to 
revise the labor-related share. Additionally, this rule finalizes the 
proposal 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).
b. 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 finalizing the addition of two 
quality measures to the HH QRP, the removal of two Outcome and 
Assessment Information Set (OASIS)-based data elements the codification 
of the previously finalized 90 percent OASIS data completion threshold 
policy in the Code of Federal Regulations (CFR) and the public 
reporting of four measures. We also note that the proposed rule 
included a request for information on future HH QRP measure concepts 
and an update on health equity in the HH QRP.
c. Expanded Home Health Value-Based Purchasing (HHVBP) Model
    In accordance with the statutory authority at section 1115A of the 
Act, we are finalizing proposed 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 with conforming regulation text 
changes for the expanded HHVBP Model. We are also including an update 
on health equity and a reminder about public reporting.
d. Home Intravenous Immune Globulin (IVIG) Items and Services
    As required under Division FF, section 4134 of the Consolidated 
Appropriations Act, 2023 (CAA, 2023), this final rule will 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).
e. Hospice Informal Dispute Resolution and Special Focus Program
    As required under Division CC, section 407 of the Consolidated 
Appropriations Act of 2021 (CAA, 2021), as codified in section 1822(b) 
of the Act, this final rule will 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 finalizing our proposed regulatory changes 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.
f. 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) <a href="https://www.govinfo.gov/link/plaw/116/public/136">https://www.govinfo.gov/link/plaw/116/public/136</a> 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 finalizing the 
proposed 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 addresses 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 will fall under the new benefit.
    This rule also implements 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 under Part B for leg, arm, back, and neck braces. This rule 
codifies the existing definition of a brace found in the Medicare 
Benefit Policy Manual (CMS Pub. 100-02) and clarifies that this 
definition encompasses newer, technology-powered devices.
g. 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. This rule will codify our long-standing refill policy, with 
some changes. We proposed to require documentation indicating that the 
beneficiary has confirmed their need for the refill within the 30-day 
period prior to the end of the current supply. We also proposed 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 sought comments for potential future rulemaking 
on ways to balance beneficiary burden with the potential program 
integrity risk of not verifying the beneficiary's need for recurring 
supplies for certain individuals with permanent conditions and will 
consider the commenter submissions.
h. Provider and Supplier Enrollment Requirements
    The purpose of our provider enrollment provisions is to strengthen

[[Page 77678]]

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 these objectives will assist in protecting the Trust Funds 
and Medicare beneficiaries.
2. Summary of the Provisions of This Final Rule
a. Home Health Prospective Payment System (HH PPS)
    In section II.B.2. of this final rule, we discuss comments related 
to access to home health aide services. In section II.C.1. of this 
rule, we are finalizing a permanent prospective adjustment of -2.890 
percent to the CY 2024 home health payment rate.
    In section II.C.2. of this rule, we are finalizing the proposal 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 are finalizing the proposals to 
rebase and revise the home health market basket to reflect a 2021 base 
year and revise the labor-related share.
    In section II.C.4. of this rule, we are finalizing our 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 final home 
health payment update percentage for CY 2024 is 3.0 percent. 
Additionally, this rule finalizes the CY 2024 FDL ratio to ensure that 
aggregate outlier payments do not exceed 2.5 percent of the estimated 
total aggregate payments, as required by section 1895(b)(5)(A) of the 
Act.
    In section II.C.5 of this rule, we finalize our proposal to codify 
statutory payment changes for negative pressure wound therapy using a 
disposable device (dNPWT).
b. Home Health Quality Reporting Program (HH QRP)
    In section III. of this final rule, we will finalize 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 finalizes the adoption of 
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 are finalizing the removal of 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 is 
finalizing the removal of two OASIS items no longer necessary for 
collection, the M0110--Episode Timing and M2200- Therapy Need items. We 
are also finalizing 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 summarize input on 
CMS's request for information on future HH QRP measure concepts and CMS 
updates on HH QRP health equity initiatives.
c. Expanded Home Health Value Based Purchasing (HHVBP) Model
    In section IV. of this final rule, we are finalizing codification 
of the HHVBP measure removal factors at Sec.  484.380. We will remove 
five and add three quality measures to the applicable measure set. 
Along with the proposed revisions to the current measure set, we 
proposed 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 finalizing 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 finalizing to 
amend the appeals process such that reconsideration decisions may be 
reviewed by the Administrator. We are also making conforming regulation 
text changes at Sec.  484.375(b)(5). We included 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 are also including a 
reminder that we will begin public reporting HHVBP performance data on 
or after December 1, 2024.
d. 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 finalizes 
proposed 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.
e. Hospice Informal Dispute Resolution and Special Focus Program
    In section VI. of this final rule, we are finalizing 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 proposed that the hospice IDR would address 
disputes related to condition-level survey findings following a hospice 
program's receipt of the official survey statement of deficiencies. The 
proposed IDR would 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 proposed 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 finalized SFP. In section VI. of this rule, we 
are finalizing our proposal to add the hospice Special Focus Program 
(SFP) at Sec.  488.1135. In the final rule, we are finalizing 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 in the CY 2022 HH PPS rule 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 proposed SFP. The finalized 
hospice SFP becomes effective beginning the effective date of this 
final rule with implementation during CY 2024. We will periodically 
review the effectiveness of the finalized methodology and algorithm.

[[Page 77679]]

f. Durable Medical Equipment, Prosthetics, Orthotics, and Supplies 
Products and CAA 2023 Related Changes
    In section VII.A.3. of this rule, we are finalizing without 
modification the 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 finalizing revisions under 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 finalizing revisions to 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 finalizing our proposal 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 finalizing our proposal 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 finalizing the proposal 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 the amendment of 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 will 
include accessories such as zippers, liners, and padding or fillers 
that are necessary for the effective use of a gradient compression 
garment or wrap with adjustable straps.
    We are finalizing our proposal to modify and add to the existing 
HCPCS Level II codes for lymphedema compression treatment items.
    We are finalizing our proposal 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 finalizing our proposal 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 to establish payment amounts for lymphedema 
compression treatment items.
    We are finalizing our proposal to add Sec.  414.1600 to explain the 
purpose and definitions found in subpart Q.
    We are finalizing our proposal to add Sec.  414.1660 to address 
continuity of pricing when HCPCS codes for lymphedema compression 
treatment items are divided or combined.
    We are finalizing our proposal to add Sec.  414.1680 with details 
regarding frequency limitations for lymphedema compression treatment 
items. Medicare will cover and pay for three daytime garments or wraps 
every six months and two nighttime garments or wraps every 2 years.
    We are finalizing our proposal 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 are adding 
lymphedema compression treatment items to the definition of item at 
Sec.  414.402. We are revising Sec.  414.408 to indicate that payment 
for these items will be calculated on a lump sum purchase basis and 
payment under the program will be made in accordance with any frequency 
limitations established under subpart Q in accordance with section 
1834(z)(2) of the Act. We are also adding 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 finalizing our proposal 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 are finalizing 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.
g. Documentation Requirements for Durable Medical Equipment, 
Prosthetics, Orthotics, and Supplies Products Supplied as Refills to 
the Original Order
    We are finalizing our proposed refill documentation requirements. 
We will be updating the refill documentation requirements such that a 
beneficiary affirmation will need to be documented by the supplier. We 
will 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 will 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

[[Page 77680]]

the Office of Management and Budget under OMB control number 0938-0969 
(CMS-10417).
h. Provider and Supplier Enrollment Requirements
    We proposed several changes to our Medicare provider and supplier 
enrollment requirements. These included but were not limited to: (1) 
provisions related to hospice enrollment and ownership; and (2) 
deactivation of providers and suppliers.
3. Summary of Costs, Transfers, and Benefits
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B. Issuance of the Proposed Rule

    The proposed rule titled ``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'' appeared in the Federal Register on July, 10, 
2023 (88 FR 43654) hereinafter referred to as the CY 2024 HH PPS 
proposed rule or July 2023 proposed rule).
    The proposed rule set forth proposed payment and policy changes to 
the Medicare Home Health prospective payment system for CY 2024, 
proposed changes regarding other programs and policies, as well as 
solicited comments.
    In the sections of the rule that follow, we will present the 
proposed policies

[[Page 77682]]

and summarize and respond to the public comments received.

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 issued a 
final rule which appeared 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. We issued a final rule which appeared in the 
November 9, 2006 Federal Register (71 FR 65935), to implement the pay-
for-reporting requirement of the DRA, which was codified at Sec.  
484.225(h) and (i) in 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) using a disposable device 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 (PFS) (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-

[[Page 77683]]

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 NPWT using a disposable device 
(though this rule is finalizing 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 <a href="https://www.cms.gov/regulations-and-guidanceguidancetransmittals2020-transmittals/se20005">https://www.cms.gov/regulations-and-guidanceguidancetransmittals2020-transmittals/se20005</a>. 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 77684]]

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BILLING CODE 4120-01-C

B. Monitoring the Effects of the Implementation of PDGM

1. Routine PDGM Monitoring
    In the CY 2024 HH PPS proposed rule (88 FR 43663), CMS provided 
data analysis on 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. We received one comment on the analysis presented in the 
proposed rule.
    Comment: The commenter stated that while the utilization patterns 
before and after PDGM implementation show a continuous downward trend, 
there is lack of data analysis and explanation by CMS indicating 
whether the appropriate level of home health care is being provided to 
beneficiaries. They also suggested that CMS should expand the data 
collected to include geographic, racial, ethnic, socioeconomic, sexual 
orientation and gender identifiers which could highlight whether 
disparities in home health usage vary in diverse populations.
    Response: We thank the commenter for their feedback on the home 
health utilization data presented in the CY 2024 HH PPS proposed rule. 
The intent of the monitoring section is to show the trends in the data 
presented. We discuss our analysis of these data in the discussion of 
our RFI related to home health aides and in the discussion of the PDGM 
behavioral assumption adjustments. We will continue to monitor and 
analyze home health trends and vulnerabilities within the home health 
payment system and will consider the additional monitoring suggested by 
the commenter for future rulemaking.

[[Page 77685]]

2. Request for Information (RFI) for Access to Home Health Aide 
Services
    As we continue to focus on promoting access and value within the 
home health benefit, in the CY 2024 HH PPS proposed rule (88 FR 43654), 
we solicited comments from the public, including home health providers 
as well as patients and advocates, regarding certain trends in the data 
that coincide with home health coverage misinformation obtained 
anecdotally from beneficiaries; that is, information related to the 
provision of home health aide services as needed when a patient is 
under the home health benefit. We queried interested parties on the 
potential basis for continued decline in utilization of home health 
aide services despite persistent need, particularly among higher acuity 
beneficiaries. Also, in an effort to better understand the decline in 
utilization and improve the provision of the home health aide services 
under the home health benefit, we solicited comments specifically on 
how home health agencies' recruitment and retention challenges, wage 
disparities, aide care impact and wage alignment, Medicare-Medicaid 
coordination, physician plans of care, and expected beneficiary 
outcomes might be interconnected.
    In response to our request for information on access to home health 
aide services, we received a total of 85 comments, where commenters 
highlighted a multitude of challenges and offered several 
recommendations to improve the provision of home health aide services 
under Medicare. These comments and our responses are summarized in this 
section of the rule.
    Comment: Commenters broadly stated that the decline in the 
utilization of home health aide services is not indicative of a reduced 
need for such services. Commenters also stated that despite Medicare 
laws allowing for substantial home health aide hours, the actual 
provision is dwindling, especially affecting those with chronic or 
long-term conditions, who often require a combination of skilled and 
aide services for optimal health and safety at home. A commenter 
further stated that both CMS' and home health agencies' policies and 
practices have resulted in barriers that devalue and disincentivize the 
provision of these essential services. Specifically, the commenter 
stated that Medicare's current payment model, PDGM, discourages HHAs 
from employing aides and providing necessary aide services. The 
commenter stated that this is especially true for patients with high 
functional impairments and multiple comorbidities. The commenter stated 
``the PDGM base calculation amount favors post-institutional care and 
the initial 30 days of services through higher case-mix adjustment for 
admission source and timing and there is a low percentage of additional 
reimbursement for beneficiaries with high functional impairments and 
multiple comorbidities, relative to beneficiaries with low functional 
impairments and no co-morbidities.'' The commenter stated that because 
these are ostensibly the beneficiaries that would need the most aide 
services (and HHAs have surmised that the more aide visits they provide 
the lower their overall reimbursement will potentially be in the 
future), this has led HHAs tell patients that ``Medicare does not pay 
for aides.''
    In addition to comments stating that the PDGM discourages the 
provision of aide services, commenters also stated that HHAs' engage in 
selective practices and strategic preference for serving lower acuity 
patients to maximize profits, which they assert has a 
disproportionately negative effect on higher acuity patients (that is, 
those with multiple comorbidities or high functional impairment) and 
often leaves them underserved or completely neglected. Commenters 
suggested that CMS has not fulfilled its oversight of HHAs conducting 
such discriminatory practices and has failed to enforce the 
nondiscrimination conditions of participation for Medicare-certified 
HHAs. They stated that CMS should investigate the practices of HHAs 
that tend to exclude or underserve beneficiaries with chronic, 
disabling conditions and take enforcement action to ensure that 
patients with long-term disabilities do not face discrimination in the 
provision of aide services.
    Commenters identified multiple barriers that they stated affected 
HHAs in recruiting and retaining home health aides, including low 
compensation, competition for labor in different job markets, 
inadequate/limited training opportunities, and demanding work 
conditions. Commenters' suggestions to overcome these barriers included 
improved compensation, including aide services more directly in care 
plans, providing advanced training, and establishing centralized 
systems for employee development.
    Commenters stated that they had noticed wage disparities between 
home health aides and similar positions in other care settings, such as 
inpatient hospitals and nursing homes, attributing the disparities to 
various factors like the nature of work, working conditions, and level 
of institutional support available. They stated that reevaluating 
compensation structures is necessary for parity. A commenter stated 
that CMS's episodic reimbursement for home health does not support 
robust staffing, particularly in rural areas. Commenters stated this 
creates a situation where HHAs cannot justify separate visits by a home 
health aide when nurses or occupational therapists can perform these 
functions within their scope of practice during a skilled or therapy 
visit.
    Commenters urged both HHAs and CMS to overhaul the current 
reimbursement compensation to better incentivize fulfillment of home 
health aide services in order to ensure aides receive fair wages 
commensurate with the critical nature of their role and their impact on 
patient care. A commenter suggested the need for CMS to establish new 
payment mechanisms specifically designed to ensure HHAs are compensated 
fairly for delivering all necessary services, specifically home health 
aide services.
    Commenters stated that the effectiveness of coordination between 
Medicare and Medicaid varies by state and is generally limited 
(especially for dually eligible beneficiaries) and that gaps in 
coordination are a systemic issue arising from differences in 
eligibility, coverage, and administrative factors. Commenters also 
stated that although dually eligible beneficiaries might receive 
somewhat better access to aide services through Medicaid, better care 
coordination is vital for boosting utilization rates and addressing 
disparities in access to services.
    Further, commenters stated that they believed a dual issue affected 
physicians' care plans for home health aide services. They stated there 
is limited availability of aides to provide the aide services included 
on care plans due to difficulties in finding qualified staff and 
inadequate reimbursements from CMS, as well as the fact that physicians 
themselves are increasingly less likely to include home health aide 
services in care plans. Commenters stated that this physician hesitance 
is fueled by HHAs reporting that aide services are either very limited 
or not available at all. Commenters stated that, as a result, 
practitioners have substantially reduced or altogether eliminated 
requests for aide services. Additionally, commenters stated that HHAs 
often refuse to initiate aide services unless family/caregivers commit 
to learning how to perform the aide functions themselves (even if those 
caregivers are not willing and/or able to continue the care and even if 
the patient objects to having a family member

[[Page 77686]]

provide aide care). A few commenters stated that HHAs also have a 
practice of either refusing to staff aides adequately or understaffing 
them deliberately.
    Commenters also stated that there were consequences to 
beneficiaries' lack of adequate access to home health aide services, 
including outcomes such as unnecessary hospitalizations, nursing 
facility admissions, potentiated health complications, family/caregiver 
burnout, and even forced institutionalizations that lead to a 
significant loss of independence and quality of life.
    Response: CMS appreciates the comments and suggestions received 
regarding home health aide service utilization (especially among higher 
acuity Medicare beneficiaries), the status of Medicare and Medicaid 
home health aide coordination, physician care plans, HHA recruitment 
and retention challenges, as well as wage disparities in other care 
settings, in influencing both the availability and quality of home 
health aide services for Medicare beneficiaries. We thank commenters 
for their feedback suggesting various changes for the equitable and 
adequate provision of home health aide services, as well as for payment 
reform, recruitment, and retention strategies, improved inter-program 
coordination between Medicare and Medicaid, and an overall shift in how 
the value of home health aide services is recognized, how home health 
aides are compensated, and how home health aide services are 
effectively integrated into plans of care. We do note that the current 
HH PPS, which generally bundles payment for all goods and services 
furnished in a 30-day period, including home health aide services, is 
set forth by statute. As such, suggestions related to the payment 
structure of the HH PPS, including regarding how aides are paid, are 
more appropriately addressed to Congress for consideration.
    We would like to thank commenters for their responses regarding 
payment rates for home health aide services. In response to the 
comments detailing concern that HHAs may be influencing practitioners 
to curtail or omit aide services, or are refusing to initiate such 
services as ordered, we would like to direct readers' attention to the 
home health Conditions of Participation (CoPs) at 42 CFR 484.60. As a 
reminder, per the regulations, each patient is required to receive home 
health services as delineated in an individualized plan of care. Such 
plan of care must specify the care and services necessary to meet the 
patient-specific needs as identified in the comprehensive assessment, 
including identification of the responsible discipline(s), and the 
measurable outcomes that the HHA anticipates will occur as a result of 
implementing and coordinating the plan of care. It is improper for an 
HHA to unduly influence a practitioner based on the HHA's own service 
constraints.
    Overall, the feedback provided by respondents will help guide our 
policy formulation processes. One of CMS' objectives is to continually 
enhance home health policies to optimize both access and quality of 
care for Medicare beneficiaries. Likewise, in keeping with the 
President's Executive Order (E.O.) on Increasing Access to High-Quality 
Care and Supporting Caregivers,\1\ we find the comments and suggestions 
received relevant to identifying ``gaps in knowledge about the home- 
and community-based workforce serving people with disabilities and 
older adults.'' As such, all comments and suggestions will be 
considered alongside the goals of this E.O., including identifying 
opportunities to expand analyses, supplementing data, or launching new 
efforts to provide important data on the home- and community-based 
workforce, such as home health aides, as appropriate. This information 
may assist in policy development, addressing barriers, and fostering 
coordination under the home health benefit for future regulatory 
updates.
---------------------------------------------------------------------------

    \1\ Exec. Order No. 14,095, 3 CFR 24669-24676. (April 18, 2023).
---------------------------------------------------------------------------

C. Provisions for CY 2024 Payment Under the HH PPS

1. CY 2024 Final 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 as to documentation, 
coding, and the LUPA thresholds, 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 the effects of 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 in CYs 2021 and 2022 relating to the behavior assumptions that 
were finalized in the CY 2019 HH PPS final rule with comment period, or 
to the negative 4.36 percent behavior change assumption adjustment, 
that was finalized in the CY 2020 HH PPS final rule with comment 
period.
    In the CY 2023 HH PPS final rule (87 FR 66796), we concluded that 
the three assumed behavior changes had in fact occurred. Additionally, 
this monitoring showed that other behavioral changes, such as changes 
in the provision of therapy and functional impairment levels, also 
resulted from implementing the PDGM. We also restated, as we originally 
noted in the CY 2020 HH PPS final rule with comment period (84 FR 
60513), that we interpret actual behavior changes to encompass both 
behavior changes that were previously outlined and assumed by CMS, as 
well as other behavior changes that were 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 other behavior changes occurred, including that 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 the CY 2024 HH PPS 
proposed rule (88 FR 43663 through 43671), we stated that our analysis 
continues to show that the actual 30-day periods are similar to the 
simulated 30-day periods, overall. The number of therapy visits (total 
and average) continue to decline, indicating that HHAs changed their 
behavior to reduce therapy visits. The analysis continues to support 
the presence of the original three assumed behavior changes (for 
example, in the volume of visits for LUPAs), as well as other 
individual behavior changes (for example, therapy visits). To capture 
all such behavior changes, we use the entirety of all behaviors to 
calculate estimated aggregate expenditures. The law instructs CMS 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, as required by section 1895(b)(3)(A)(iv)

[[Page 77687]]

and 1895(b)(3)(D) of the Act. We accordingly use the aggregate data.
    Section 4142(a) of the CAA, 2023, requires 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 <a href="https://www.cms.gov/medicare/medicare-fee-for-service-payment/homehealthpps/hh-pdgm">https://www.cms.gov/medicare/medicare-fee-for-service-payment/homehealthpps/hh-pdgm</a>. In the CY 2024 HH PPS 
proposed rule, we continued to describe actual behavior changes (88 FR 
43663 through 43672) identified through our analysis of CYs 2020-2022 
claims data. We posted a descriptive statistics file with the release 
of the CY 2024 HH PPS proposed rule. Additionally, the LDS file 
available for purchase contained the simulated 60-day episodes and 
actual 30-day periods. Furthermore, to promote data transparency, we 
will continue to describe the behavior changes analyzed through CY 2026 
claims and we will continue to post the descriptive statistics file and 
the LDS file with the simulated 60-day episodes and actual 30-day 
periods in annual rulemaking.
(b) Method To Annually Determine the Impact of Differences Between 
Assumed Behavior Changes and Actual Behavior Changes on Estimated 
Aggregate Expenditures
    In the CY 2022 HH PPS proposed rule (86 FR 35889 through 35892) we 
solicited comments on our methodology to annually determine the impact 
of differences between assumed and actual behavior changes on estimated 
aggregate expenditures. We received feedback from this comment 
solicitation, as well as commenter's feedback when this methodology was 
proposed in the CY 2023 HH PPS proposed rule. We finalized this 
methodology in the CY 2023 HH PPS final rule (87 FR 66804) stating that 
this methodology aligns with the statutory requirements as required by 
1895(b)(3)(D) of the Act. Under that methodology, for CYs 2020 through 
2026, we will evaluate whether the 30-day budget neutral payment rate 
and resulting aggregate expenditures are equal under the PDGM to what 
they 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.
    <bullet> Create simulated 60-day episodes from actual 30-day 
periods.
    <bullet> Price out the simulated 60-day episodes and determine 
aggregate expenditures.
    <bullet> Price out only the actual 30-day periods which were used 
to create the simulated 60-day episodes and determine aggregate 
expenditures.
    <bullet> Compare aggregate expenditures between the simulated 60-
day episodes and actual 30-day periods.
    <bullet> Determine what the 30-day payment rate should have been to 
equal the simulated 60-day episodes aggregate expenditures using the 
153-group case-mix system and 60-day unit of payment.
(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
    <bullet> 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.\2\ Again, this is to ensure a simulated 60-day episode (simulated 
from two 30-day periods) does not overlap years.
---------------------------------------------------------------------------

    \2\ 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.
---------------------------------------------------------------------------

    <bullet> Beneficiaries and all of their claims if they have 
overlapping claims from the same provider (as identified by CCN).\3\
---------------------------------------------------------------------------

    \3\ 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 than only a subset, so as not to create a conflict 
in assigning episode timing.
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    <bullet> Beneficiaries and all of their claims if three or more 
claims from the same provider are linked to the same occurrence code 50 
date.\4\
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    \4\ 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.
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(b) Assumptions
    <bullet> 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.
    <bullet> 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

[[Page 77688]]

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.
    <bullet> 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) \5\ 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.
---------------------------------------------------------------------------

    \5\ <a href="https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HomeHealthPPS/CaseMixGrouperSoftware">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HomeHealthPPS/CaseMixGrouperSoftware</a>.
---------------------------------------------------------------------------

    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 the 
specific year (for example, 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.
(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. While we did not propose any changes to the 
methodology finalized in the CY 2023 HH PPS final rule (87 FR 66804), 
we did receive comments on the CY 2024 HH PPS proposed rule which are 
summarized in this section.
    Comment: Many commenters opposed the behavioral adjustment 
methodology finalized in the CY 2023 HH PPS final rule based on legal 
and technical concerns that mostly repeated objections raised in the 
last rulemaking cycle. The legal arguments mostly restated we are 
violating the Medicare statute. These commenters repeated technical 
concerns including the use of therapy visits, accepted diagnosis codes, 
timing assignment, and missing OASIS items. Commenters stated ``home 
health agencies have predictably provided fewer therapy sessions,'' and 
the methodology's reliance on this change in therapy utilization is not 
appropriate to use in determining behavior changes since the law 
required the elimination of the therapy thresholds. Commenters again 
stated the methodology is unreasonable because ``claims billed under 
one case-mix system, with different incentives, coding and billing 
rules, and unit of payment'' cannot be compared. They requested that 
CMS reverse the permanent payment adjustment taken in CY 2023, withdraw 
the proposal of a permanent payment

[[Page 77689]]

adjustment for CY 2024, and develop and propose a new methodology after 
input from a technical expert panel. Similarly, a few commenters stated 
again that the methodology performs an unauthorized rebasing of the 30-
day payment rate. Lastly, several commenters stated beneficiaries using 
home health are becoming more complex and have higher acuity needs, for 
which reimbursement does not match. We received a new comment on the 
methodology requesting CMS to consider how to further integrate the 
acuity of patients into the behavioral assumption methodology and how 
to better account for acuity overall in the PDGM.
    Response: We appreciate the comments and recommendations we 
received regarding the behavior adjustment methodology. We did not 
propose any changes to the behavior adjustment methodology in this 
year's proposed rule and will not be finalizing any changes. As noted, 
most of these comments were similar to comments we received on the CY 
2023 HH PPS proposed rule, so we refer readers to our responses to 
these concerns in the CY 2023 HH PPS final rule (87 FR 66797 through 
66804). In that rule, for example, we responded to commenters' 
assertions that we violated the Medicare statute, as well as 
commenters' disagreement with technical concerns, including the 
inclusion of therapy provision, with our methodology.
    One such argument to which we responded in the CY 2023 HH PPS final 
rule (87 FR 66802) was a theory that we implemented an unauthorized 
rebasing of the payment rates. The law requires us to determine the 
difference between assumed versus actual behaviors on estimated 
aggregate expenditures. Therefore, we continue to believe that the best 
reading of the law requires us to retrospectively determine if the 30-
day payment amount in CYs 2020 through 2022 resulted in the same 
estimated aggregate expenditures if the 60-day unit of payment and the 
PDGM case-mix adjustment had not been implemented. As stated 
previously, the finalized methodology compares the payment rate and 
aggregate expenditures based on assumed behaviors to what the payment 
rate and estimated aggregate expenditures would have been using actual 
behaviors, which we believe is what the law requires.
    We thank the commenters for their suggestion that they should be 
paid more because patient acuity has increased. We finalized a policy 
in the CY 2019 HH PPS final rule with comment period (83 FR 56515) to 
annually recalibrate 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. It also allows us to be as accurate and up to date as 
possible when measuring relationships between resource use and 
functional points, functional threshold levels, comorbidities, LUPA 
thresholds, and case-mix weights. These aspects of the PDGM capture 
patient acuity. Further, because our finalized methodology utilizes the 
most recent claims data (which includes case-mix), patient acuity is 
reflected in the data.
(d) CY 2020 Results
    This section discusses the final results that CMS determined from 
CY 2020 claims data that was previously published in the CY 2023 HH PPS 
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 did not 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 B1.

[[Page 77690]]

[GRAPHIC] [TIFF OMITTED] TR13NO23.003

    As shown in Table B1 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 HH PPS 
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 B2.

[[Page 77691]]

[GRAPHIC] [TIFF OMITTED] TR13NO23.004

    As shown in Table B2 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 Final Results
    We will continue the practice of using the most recent complete 
home health claims data at the time of rulemaking. The CY 2022 analysis 
presented in the CY 2024 HH PPS proposed rule was considered 
``preliminary'' and as more data became available from the latter half 
of CY 2022, we updated our results. As we did with the CY 2024 HH PPS 
proposed rule, the HH PPS limited data set (LDS) file released with 
this final 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 final 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.\6\ In addition, the final 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,\7\ 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 2024 
final rule utilizes the CY 2022 finalized data for determining the 
behavior adjustment needed to calculate 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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    \6\ <a href="https://www.cms.gov/research-statistics-data-and-systems/files-for-order/limiteddatasets/home_health_pps_lds">https://www.cms.gov/research-statistics-data-and-systems/files-for-order/limiteddatasets/home_health_pps_lds</a>.
    \7\ <a href="https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HomeHealthPPS/Home-Health-Prospective-Payment-System-Regulations-and-Notices">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HomeHealthPPS/Home-Health-Prospective-Payment-System-Regulations-and-Notices</a>.
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    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 8,593,266 30-
day periods of care and dropped 539,048 30-day periods of care that had 
claim occurrence code 50 date after October 31, 2022. We also excluded 
894,333 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 6,105 30-day periods were excluded.
    Additionally, we excluded 18,296 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 (69.6 percent) and single 30-day periods 
of care (30.4 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 7,124,359 actual 30-day periods of care and 4,199,746 
simulated 60-day episodes of care for CY 2022.
    Using the final dataset for CY 2022 (7,124,359 actual 30-day 
periods which made up the 4,199,746 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 B3. 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 what the actual CY 2022 30-day base 
payment rate should have been to equal aggregate expenditures that we 
calculated using the simulated CY 2022 60-day episodes. We determined 
the CY

[[Page 77692]]

2022 30-day base payment rate should have been $1,839.10 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 B2), 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 ($1,839.10) 
payment rates. This difference is the retrospective dollar amount 
needed to offset payment. Our results are shown in Table B3.
[GRAPHIC] [TIFF OMITTED] TR13NO23.005

    As shown in Table B3, a permanent prospective adjustment of -1.767 
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) CY 2024 Final Permanent Adjustment and Temporary Adjustment 
Calculations
    As discussed in the CY 2023 HH PPS final rule (87 FR 66808), to 
offset fully the increase in estimated aggregate expenditures for CYs 
2020 and 2021 based on the impact of the differences between assumed 
and actual behavior changes, in CY 2023, CMS would have 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 have resulted in a significant negative adjustment in 
a single year. However, as we noted at the time, and as still is 
applicable, if the PDGM 30-day base payment rate remained higher than 
it should be, there will be a compounding effect, potentially creating 
the need for an even larger reduction to adjust for behavioral changes 
in future years. After considering all options, CMS proposed and 
finalized the application of only a permanent adjustment to the CY 2023 
base payment rate. We believed, and continue to believe, this mitigates 
the need for a larger permanent adjustment and reduces 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. We exercised our discretion to implement adjustments in a time 
and manner determined appropriate, under section 1895(b)(3)(D) of the 
Act, to finalize a -3.925 percent (half of the -7.85 \8\ percent) 
permanent adjustment to the CY 2023 30-day payment rate. 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 (that is, the remaining half not applied to the CY 
2023 payment rate) in future rulemaking, and any additional adjustments 
(for example, CY 2022) needed to the base payment rate, to account for 
behavior change based on more recent data analysis. We note that the 
total permanent adjustment based on CY 2022 data did not have any 
previous behavior adjustments applied.

[[Page 77693]]

However, as described later in this section, we recognize for CY 2024 
we must account for adjustments made in CY 2023.
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    \8\ We initially proposed a -7.69 percent permanent adjustment 
in the CY 2023 HH PPS proposed rule (87 FR 37620). As more data 
became available from the latter half of CY 2021, we updated our 
results.
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    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 $1,839.10 (based on actual behaviors) (shown in 
Table B3) 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 B4 and B5.
[GRAPHIC] [TIFF OMITTED] TR13NO23.006

[GRAPHIC] [TIFF OMITTED] TR13NO23.007

    We remind readers when we update the national, standardized 30-day 
period payment amount (section II.C.4.2) that 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 final 
permanent adjustment by simply subtracting -3.925 percent from the 
total permanent adjustment of -9.477 percent (updated from -9.356 
percent in the proposed rule as more data became available), as 
described further below.
    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 -9.477 percent, which is converted to a 
0.90523 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) = 0.90523 (9.477 percent) divided by 0.96075 (3.925 
percent). The resulting factor (1-x) is 0.94221, which is converted to 
a 5.779 percent (updated from 5.653 percent in the CY 2024 HH PPS 
proposed rule (88 FR 43678) as more data became available) reduction to 
the CY 2024 national, standardized base payment rate. In other words, 1 
minus the factor 0.94221 equals 0.05779 which is equal to a 5.779 
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 -5.779 percent permanent 
adjustment to the CY 2024 base payment rate.
    To calculate the temporary adjustment, we would add the CY 2022 
temporary adjustment dollar amount of $1,405,447,290 to the previously 
finalized CYs 2020 and 2021 dollar amounts for a total of 
$3,489,523,364. We stated in the CY 2023 HH PPS final rule (87 FR 
66804) and the CY 2024 HH PPS proposed rule (88 FR 43678), 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, in the CY 2023 HH PPS proposed rule (87 FR 37682), we opted to 
implement only the permanent adjustment and solicit

[[Page 77694]]

comments on the implementation of a temporary adjustment, as we 
believed for that year applying both would result in too significant of 
a reduction in the payment rate in one year. Given that the magnitude 
of implementing both the temporary and permanent adjustments for CY 
2024 rate setting may also result in a significant reduction of the 
payment rate, we similarly did not propose to take the temporary 
adjustment in CY 2024. As we are required by Section 1895(b)(3)(D)(iii) 
of the Act, we will propose a temporary adjustment factor to the 
national, standardized 30-day base payment rate when we propose this 
temporary payment adjustment in future rulemaking.
    We received 343 comments on the permanent prospective behavior 
change adjustment on the CY 2024 home health payment rate which are 
summarized in this section. Similar to comments received on the CY 2023 
permanent adjustment, the majority of commenters disagreed with the 
proposed permanent adjustment to the CY 2024 payment rate.
    Comment: Overall, commenters raised concerns that the proposed rate 
cut would be a threat to home health access. Further, industry 
advocates submitted data from hospitals and health systems to support 
their assertion that HHA referrals for Medicare beneficiaries are 
increasingly being rejected, and the number of patients referred to 
home health and subsequently admitted is dropping.
    These commenters interpret these trends to be indicative of 
declining access to home health services and state that CMS's 
implementation of the PDGM and behavior adjustment resulting in rate 
cuts are major contributors. Commenters stated that a rate cut will 
affect beneficiary access by forcing HHAs to close, sell, reduce 
service areas, reduce admissions, and struggle to retain staff, while 
many others are operating with, or will operate with, negative margins 
if the CY 2024 permanent rate adjustment is finalized. These commenters 
contend that CMS does not have an accurate financial picture of 
industry stability, as we do not account for overall margins (for 
example, Medicare Advantage), rather just Medicare Fee-For-Service 
(FFS) margins when considering margin analyses. A commenter stated that 
``the economic model of HHAs necessitates a view consistent with the 
HHAs' evaluation of its overall financial condition,'' suggesting that 
it is common for Medicare's FFS payment to subsidize shortfalls from 
other payers.
    Response: We appreciate industry advocates' dedication to ensuring 
continued access to home health services. We recognize there is always 
a level of concern that accompanies a payment rate decrease and we 
remind readers that, by law, as described in section 1895(b)(3)(D) of 
the Act, we are required to ensure that estimated aggregate 
expenditures under the HH PPS are equal to our determination of 
estimated aggregate expenditures that otherwise would have been made 
under the HH PPS in the absence of the change to a 30-day unit of 
payment and changes in case-mix adjustment factors. We appreciate 
providers', beneficiaries', and other stakeholders' commitment to the 
sustainability of the home health benefit.
    As we noted above, we reprice the base payment rate based on actual 
behavior changes by HHAs, not on how the behavior changes impact HHA 
margins. In any event, CMS looked closely at our data to ensure the 
payment rate adequately covers the costs reported by HHAs, without 
creating unnecessary hardship to providers and maintaining access to 
quality services for all beneficiaries. Maintaining access is one of 
CMS's priorities when making policy decisions. We do not intend to 
obstruct the provision of home health services to any beneficiary who 
qualifies for this benefit.
    Overall, CMS's data on the cost of providing care (as reported by 
HHAs on the Home Health Medicare Cost Reports (CMS Form 1728-20, OMB 
No. 0938-0022)) and the margin analysis, along with data reported by 
MedPAC in their annual Medicare payment policy reports to the Congress, 
indicate that the cost of providing home health care remains, on 
average, below the base payment rate and that HHAs in general continue 
to experience high profit margins. CMS's analysis, shown in Table B4 of 
the CY 2024 HH PPS proposed rule, indicates that the CY 2022 national, 
standardized 30-day period payment rate was approximately 45 percent 
more than the CY 2022 estimated 30-day period cost (88 FR 43665). 
MedPAC's 2023 March Report to the Congress \9\ found that in 2021, home 
health agencies' average cost per 30-day period decreased by 2.9 
percent and that Medicare's payment per in-person visit increased by 
17.7 percent. Medicare margins for freestanding agencies averaged 24.9 
percent in 2021, up from 20.2 percent in 2020 and 15.4 percent in 2019. 
These high margins indicate that the increase in payments in 2021 far 
exceeded the increase in costs, which undermines commenters' assertion 
that CMS's modest (by comparison) cuts to the base rate in 2023 would 
exacerbate any problems with access to care. Further, MedPAC's 
projected Medicare margin for HHAs for 2023 is 17.0 percent, which 
includes the statutory adjustment to the base payment rate in 
accordance with the statutory requirement to determine the impact of 
differences between assumed behavior changes and actual behavior 
changes on estimated aggregate expenditures in response to the change 
in case-mix adjustment and the 30-day period payment.
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    \9\ Report to Congress, Medicare Payment Policy. Home Health 
Care Services, Chapter 8. MedPAC. March 2023 <a href="https://www.medpac.gov/wp-content/uploads/2023/03/Ch8_Mar23_MedPAC_Report_To_Congress_SEC.pdf">https://www.medpac.gov/wp-content/uploads/2023/03/Ch8_Mar23_MedPAC_Report_To_Congress_SEC.pdf</a>.
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    Some commenters pointed to the number of HHAs with negative 
margins. Using Medicare cost reports with a year end of December 31, 
2022, approximately 21 percent of HHAs have margins below zero percent. 
We are aware that some HHAs face financial difficulties, but the 
behavior adjustment is an aggregate adjustment that impacts the base 
payment rates of all HHAs equally. Our analysis, shown in Table B6, 
indicates that even prior to the PDGM, approximately 20 to 23 percent 
of freestanding HHAs had margins below zero percent, indicating that 
this phenomenon pre-dated the PDGM, and are not the result of the rate 
adjustments related to the initial behavior assumptions applied in CY 
2020.

[[Page 77695]]

[GRAPHIC] [TIFF OMITTED] TR13NO23.008

    With respect to the comment that CMS must look at the HHAs' overall 
financial condition (that is, overall margins), we have never endorsed 
the view that Medicare funds should be used to subsidize reimbursement 
rates from other payers--a policy that would be inconsistent with our 
obligation to be responsible stewards of the Medicare Trust Funds and 
would ultimately increase costs to Medicare beneficiaries, taxpayers, 
or both. As we noted in the CY 2023 HH PPS final rule we responded to 
this assertion stating: ``Medicare has never set payments to cross-
subsidize other payers. Section 1861(v)(1)(A) of the Act states that 
under the methods of determining costs, the necessary costs of 
efficiently delivering covered services to individuals covered by the 
insurance programs established by this title will not be borne by 
individuals not so covered, and the costs with respect to individuals 
not so covered will not be borne by such insurance programs'' (87 FR 
66807).
    While CMS monitors the payment rate to ensure it is adequate for 
providing care, MedPAC further assesses access to care by reviewing 
several indicators to determine the level at which payments will be 
adequate to cover the costs of providing care of a provider in any 
given year. Specifically, they examine the supply of home health 
providers, annual changes in the volume of services, quality of care, 
and access to capital, in addition to the relationship between 
Medicare's payments and providers' costs. Their annual reports indicate 
that prior to and following the implementation of the PDGM, the payment 
adequacy indicators for home health care have been positive.
    Finally, we observed many methodological weaknesses in the analyses 
submitted by commenters. It is unclear whether the proprietary data on 
which commenters base their analyses includes referrals from only 
Medicare FFS beneficiaries or also includes referrals from patients 
covered by other payers, which means the entire analysis may be inapt 
for Medicare FFS policy. In addition, the proportion of hospital 
referrals rejected by HHAs does not equate to the proportion of 
qualifying beneficiaries who are denied care. The data fails to capture 
why the beneficiary was rejected--for example, because the analysis 
focuses on numbers of referrals denied rather than numbers of 
beneficiaries denied care, the rejection referral proportion could be 
inflated by a small number of beneficiaries rejected from multiple 
HHAs, or by beneficiaries rejected from one HHA but who ultimately 
received care from another HHA. It also fails to indicate that the HHA 
did in fact reject the referral and why it was rejected (for example, 
payment or staff related), or whether there was another reason the 
patient did not receive home health services, such as patient refusal 
or readmission to an inpatient facility.
    Further, the data submitted by the commenters is deficient in 
analyzing the characteristics of the beneficiaries who are receiving 
home health services versus those that do not. The usefulness of such 
analysis would be to potentially show whether HHAs are strategic in 
accepting certain types of patients over others. In response to a 
similar home health rate decrease (CY 2011 HH PPS final rule), in which 
CMS finalized a 3.79 percent rate reduction, a commenter stated that 
``HHAs may become more selective in their acceptance of medically 
difficult patients who are likely to utilize more services'' (75 FR 
70375). Additionally, in the CY 2023 HH PPS final rule we quoted an 
article published in February 2020, in which the National Association 
for Home Care and Hospice (NAHC) stated ``categorically, across the 
board, we're going to reduce our therapy services'' because of the PDGM 
(87 FR 66798). A comment letter received by NAHC on the CY 2023 
proposed rule also attempted to outline, how historically, rate cuts to 
Medicare home health services alter how HHAs provide care. 
Compellingly, we also received a significant number of comments in 
response to the CY 2024 HH PPS proposed rule supporting this concept. 
These comments are discussed below.
    Comment: Commenters indicated that HHAs may also choose which 
patients to accept on service to maximize payment. For example, a 
patient advocate group noted that ``HHAs self-select the Medicare 
patients they will serve (or not serve), and then HHAs determine the 
services they provide, based on their hiring choices and OASIS 
assessments.'' This commenter stated that home health care has become 
``big business,'' and stated that ``HHAs focus

[[Page 77696]]

more on profits for shareholders and less on critically needed services 
for patients.'' Another commenter stated, ``the venture capital backed 
agencies are using data-mining solutions to ensure a profit is made. 
This includes everything from the heavily scrutinized referral 
acceptance procedure to ensure `profitable' patients are chosen over 
`non-profitable' patients and the rationing of care based on what the 
data shows to create profit from decreasing direct care costs.''
    Response: Our previous response related to margins suggests that, 
as some commenters have claimed, HHAs may be strategically admitting or 
denying beneficiaries based to maximize their margins. We are concerned 
by suggestions that the ``referral rejections'' and perceived access to 
care issue that industry advocates have cited to us are in fact being 
caused by strategic behavior. We would be interested to receive data 
and analysis comparing beneficiaries who are receiving home health 
services versus those who are not, which could help inform future 
policy proposals. The data we received does not address that issue, and 
CMS's review of utilization software websites designed to guide HHAs to 
the most profitable referrals and to identify ways to decrease costs 
supports these commenters assertions. For these reasons, we cannot 
credit home health agencies' conclusion that either behavioral 
adjustments or the PDGM are the root cause of the access issues 
reported by beneficiaries.
    We will continue to monitor home health utilization, claims data, 
and home health cost reports to identify trends that may indicate 
vulnerabilities and deficiencies in the home health prospective payment 
system and potentially affect access to care. Given this monitoring and 
analyses showing that the home health payment exceeds the cost of 
providing care, we would expect that providers would not have to reject 
referrals because of inadequate payment. In fact, due to the newly 
implemented case-mix system designed to encourage a varied distribution 
of services, we would not only expect that agencies would not have to 
reject referrals but be well-positioned to accept a wide range of 
referrals regardless of the services needed.
    We are aware of the changes in the home health industry, including 
buyouts and increased interest of private equity groups. These shifts 
will undoubtedly change the landscape of home health; however, we 
remind stakeholders that Medicare FFS sets rates to cover costs that 
align with Medicare's principles of reasonable cost determination as 
set out at 42 CFR 413.9, not to ensure high profit margins. The home 
health benefit uses a prospective payment system that is inclusive of 
all care required in a 30-day period of care. This method of payment is 
made based on a predetermined, base payment amount. The home health 
case-mix system, the PDGM, was created to align the payment system more 
closely with patient characteristics and ensure that payment accurately 
meets the resource needs of various types of patients. This helps HHAs 
to be paid appropriately for a wide range of patients with varying care 
needs and improves the likelihood that clinically complex and ill 
beneficiaries and patients coming from the hospital will have adequate 
access to home health care. In the CY 2019 HH PPS final rule with 
comment period (83 FR 56448), where we finalized the implementation of 
the PDGM, there was some commenter concern that the PDGM may introduce 
``inappropriate practice patterns,'' suggesting again that HHAs may 
change how they operate in accordance with payment. However, our 
objective then, as well as now, remains to pay for the care provided as 
required by the statute. As evidenced by the behavior changes described 
in the CY 2023 HH PPS final rule, we understand that providers do 
continue to adjust practice patterns in response to payment and case-
mix changes. We also understand that venture capital and private equity 
groups are buying HHAs. This, however, does not mean that overall 
access to the benefit has been compromised and the analyses presented 
by commenters fails to show evidence that this is the case. Further, 
were the data to show definitively that overall access has been 
affected, there remains no direct link to inadequate payment. It is 
also important to note that while the commenters' data purports to show 
an increase in ``referral rejections'' beginning with the 
implementation of the PDGM and through the beginning of CY 2023, in CY 
2020 (beginning of PDGM) and each subsequent year through CY 2023, CMS 
has instituted a positive rate update for HHAs. It is unclear why HHAs 
would reject referrals when payment rates have increased each year 
since the implementation of the PDGM, and as established earlier, have 
continually exceeded the cost of providing care. Additionally, CMS is 
statutorily required, under Section 1895(b)(3)(D)(i), 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, by accounting for the impact of the differences 
between assumed behavior changes and actual behavior changes on 
estimated aggregate expenditures. This requirement under section 
1895(b)(3)(D)(i) resulted in the proposed -5.653 percent adjustment for 
CY 2024.
    We do not believe that the percentage of ``referral rejections'' 
attributable to staffing issues requires a different policy. Commenters 
did not submit any evidence that staffing shortages are due to changes 
in the payment rate or case-mix adjustment rather than the widespread 
staffing shortages that exist across the spectrum of healthcare, and in 
the general labor market. While we recognize the staffing challenges 
faced by HHAs and other healthcare providers, we are accounting for 
those staffing challenges in other ways, such as the market basket 
increase (which includes labor costs), as explained in section II.C.3 
of this final rule.
    In conclusion, we appreciate the concerns that a rate decrease may 
affect access to home health services; however, CMS's analysis of HHA 
cost reports and margin analysis, as well as MedPAC's analysis of 
profit margins, the supply of home health providers, annual changes in 
the volume of services, quality of care, and access to capital shows 
that access should remain adequate. Our discussion above indicates that 
any effect on access would not be a result of CMS paying more 
accurately for the care provided. In addition, the law requires us to 
evaluate the difference between assumed and actual behavior changes on 
estimated aggregate expenditures independently for CYs 2020 through 
2026. The payment adjustment does not include extenuating factors such 
as margins. Further, while the analyses submitted by the commenters 
allegedly show that access to home health services has been 
compromised, CMS does not have access to the proprietary data used to 
create the analysis to confirm the validity of the results.
    Final Decision: We continue to adhere to the methodology finalized 
in the CY 2023 HH PPS final rule (87 FR 66804). However, as in previous 
years, we acknowledge that taking a large permanent adjustment in a 
single year, to comply with the statutory requirement that CMS ensure 
the estimated aggregate expenditures under the PDGM are equal to the 
estimated aggregate expenditures that would have been made under the 
prior system, may be burdensome for some providers. As we have the 
discretion to implement any behavior adjustment in a time and manner 
determined appropriate, we are

[[Page 77697]]

finalizing only a -2.890 percent (half of the -5.779 \10\ percent) 
permanent adjustment for CY 2024. This approach of applying half of the 
permanent adjustment is aligned with the approach finalized in the CY 
2023 HH PPS final rule (87 FR 66808) where CMS finalized half of the 
permanent adjustment to the CY 2023 30-day payment rate.
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    \10\ We initially proposed a -5.653 percent permanent adjustment 
in the CY 2024 HH PPS proposed rule (88 FR 43679). As more data 
became available from the latter half of CY 2022, we updated our 
results.
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    However, we note the permanent adjustment to account for actual 
behavior changes in CYs 2020, 2021, and 2022, should be -5.779 percent, 
which includes the remaining ``half'' from the CY 2023 HH PPS final 
rule and the additional adjustment based on CY 2022 data. Therefore, 
applying a -2.890 percent permanent adjustment to the CY 2024 30-day 
payment rate would not adjust the rate fully to account for differences 
in behavior changes on estimated aggregate expenditures during those 
years. We will have to account for that difference, and any other 
potential adjustments needed to the base payment rate, to account for 
behavior change based on data analysis in future rulemaking.
    CMS did not propose to adjust the CY 2024 base payment rate using 
our temporary adjustment authority, as section 1895(b)(3)(D)(iii) 
allows any adjustment to be made in a time and manner deemed 
appropriate by the Secretary. However, we remind readers that without 
the full permanent adjustment (-5.779 percent) in effect, the total 
temporary dollar amount will likely continue to increase until the 
permanent adjustment is fully implemented.
2. CY 2024 PDGM LUPA Thresholds and PDGM Case-Mix Weights
(a) 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 
a policy to set the LUPA thresholds 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 may vary 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.e.3. of this final 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 a policy to reevaluate the LUPA thresholds for each PDGM 
payment group 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 (86 FR 62249), we discussed the 
influence of the COVID-19 PHE on home health utilization and finalized 
a 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 believed 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 COVID-19 PHE on the 
calculation of the case-mix weight would be minimal 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 would be more indicative of visit 
patterns in CY 2023 rather than continuing to use the LUPA thresholds 
derived from the CY 2018 pre-PDGM data. Therefore, in the CY 2023 HH 
PPS final rule we finalized a policy to update the LUPA thresholds for 
CY 2023 using data from CY 2021.
    In accordance with our policy, for CY 2024, in the CY 2024 HH PPS 
proposed rule, we proposed to update the LUPA thresholds using CY 2022 
home health claims utilization data (as of March 17, 2023). We 
solicited public comments on the proposed updates to the LUPA 
thresholds for CY 2024. These comments and our responses are summarized 
in this section of the rule.
    Comment: A few commenters expressed support for the proposed LUPA 
thresholds.
    Response: We thank the commenters for their support.
    Comment: Some commenters continued to disagree with the policy to 
reevaluate and update the LUPA thresholds annually. A commenter 
recommended that CMS reduce the LUPA threshold for all case-mix groups 
to two visits. Another commenter recommended CMS not update the LUPA 
thresholds for CY 2024 and reassess the impact of using CY 2023 data 
before making any adjustments. This commenter stated that the change in 
LUPA visit thresholds from two and three visits to the current four and 
five visit thresholds narrows the gap between the LUPA visit threshold 
and the average visits per home health period, and that as the gap 
narrows, LUPA payments will no longer represent outliers. Lastly, a 
commenter questioned the methodology used to calculate the LUPA 
thresholds.

[[Page 77698]]

    Response: We thank the commenters for their recommendations; 
however, in the CY 2019 HH PPS final rule with comment period (83 FR 
56492), we finalized the policies to set LUPA thresholds at the 10th 
percentile of visits or 2 visits, whichever is higher, for each payment 
group, and reevaluate the LUPA thresholds for each PDGM payment group 
every year based on the most current utilization data available at the 
time of rulemaking. We did not propose any changes to our finalized 
LUPA threshold policy in the CY 2024 HH PPS proposed rule. Further, our 
policy to reevaluate the LUPA thresholds ensures that they reflect, as 
accurately as possible, current home health resource use and changes in 
utilization patterns. As such, we believe that we should update the 
LUPA thresholds using CY 2022 home health claims utilization data (as 
of July 15, 2023), to ensure they are representative of the most recent 
visit patterns.
    Final Decision: We are finalizing the proposal to update the LUPA 
thresholds for CY 2024, using CY 2022 claims data (as of July 15, 
2023). The final 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 B12 and is 
also available on the HHA Center web page.\11\
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    \11\ <a href="https://www.cms.gov/medicare/enrollment-renewal/providers-suppliers/home-health-agency-center">https://www.cms.gov/medicare/enrollment-renewal/providers-suppliers/home-health-agency-center</a>.
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(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 (ADLs) 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 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 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 proposed 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: <a href="https://www.cms.gov/medicare/home-health-pps/home-health-pps-archive">https://www.cms.gov/medicare/home-health-pps/home-health-pps-archive</a>, provides a more detailed explanation as to the 
construction of these functional impairment levels using the OASIS 
items. We proposed to use the same methodology previously finalized to 
update the functional impairment levels for CY 2024.
    We solicited public comments on the updates to functional points 
and the functional impairment levels by clinical group. A summary of 
these comments and our responses are as follows:
    Comment: Several commenters opposed the proposed, updated CY 2024 
functional impairment points and levels. A commenter recommended 
delaying this update until the effect of the CY 2023 functional 
impairment levels has been assessed. This commenter also suggested that 
if future updates are warranted that it should occur in CY 2025 using 
post pandemic CY 2023 claims data.
    Response: We thank the commenters for their recommendations; 
however, performing a yearly recalibration allows us to be as accurate 
and up to date as possible when measuring the relationship between 
resource use and functional points, functional threshold levels, 
comorbidities, LUPA thresholds and case-mix weights. Therefore, we do 
not believe it would be appropriate to delay updates to the functional 
impairment points and levels for CY 2024. We continue to believe that 
updating the functional impairment levels using current data ensures 
that all variables used as part of the overall case-mix adjustment 
appropriately align home health payment with the actual cost of 
providing home health care services.
    Comment: A commenter disagreed with the method used for assigning 
the functional impairment levels, stating that the update in point 
values appears to be more aimed at achieving an arbitrarily set target 
of one-third in each level rather than a true categorization of the 
patients' clinical presentation.
    Response: We remind commenters that the functional levels are set 
so that roughly a third of periods within each clinical group are 
assigned to low, medium, and high to ensure that the case-mix system 
pays appropriately for differences in functional impairment level. The 
structure of categorizing functional impairment into low, medium, and 
high levels has been part of the home health payment structure since 
the implementation of the HH PPS. The previous HH PPS grouped home 
health episodes using functional scores based on functional OASIS items 
with similar average resource use within the same functional level, 
with approximately a third of episodes classified as low functional 
score, a third of episodes classified as medium functional score, and a 
third of episodes classified as high functional score. Likewise, the 
PDGM groups home health periods of care using functional impairment 
scores based on functional OASIS items with similar resource use and 
has three levels of functional impairment severity: low, medium, and 
high. However, the PDGM differs from the previous HH PPS functional 
variable, in that the three functional impairment level thresholds in 
the PDGM vary between the clinical groups. The PDGM functional 
impairment level structure accounts for the patient characteristics 
within that clinical group associated with increased resource costs 
affected by functional impairment. This is to further ensure that 
payment is more accurately aligned with actual patient characteristics 
and resource needs.
    Comment: Some commenters were concerned that the proposed 
functional impairment levels do not accurately reflect the actual 
functional impairment levels of home health patients or the cost to 
provide care for higher acuity patients, specifically those in the 
musculoskeletal rehabilitation, neuro rehabilitation, surgical 
aftercare, and wounds groups, as these individuals often have intense 
needs for assistance with daily living. A few commenters questioned why 
it appears there would be a reduction in reimbursement for the highest 
acuity patients and suggested that this will limit an agency's ability 
to care for these types of patients. Some commenters indicated that 
they would see fewer patients with high functional impairment, as 
several groups changed from high functional impairment to medium 
functional impairment, while others stated this change will

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incentivize for-profit agencies to hand-pick patients based on their 
predicted case mix grouping. A commenter suggested that the shift of 
patients from high functional impairment to medium functional 
impairment indicates by CMS through the HIPPS code that these patients 
are not as clinically complex and therefore would not require as many 
resources.
    Response: We have noted in past rules that we use the functional 
impairment level case-mix adjustment, developed as part of the PDGM 
case-mix, to provide the necessary payment adjustments to ensure that 
functional care needs are met based on actual patient characteristics. 
As in any case-mix system, there will be certain case-mix groups where 
a patient's costs exceed the average as well as where their costs are 
below the average. However, we do not believe that a patient assignment 
to a HIPPS category should dictate what care the patient needs. We 
expect the provision of services to be made to best meet the patient's 
care needs and in accordance with the home health CoPs at Sec.  484.60 
which sets forth the requirements for the content of the individualized 
home health plan of care which includes the types of services, 
supplies, and equipment required; the frequency and duration of visits 
to be made; as well as patient and caregiver education and training to 
facilitate timely discharge. Therefore, we do not expect HHAs to under-
supply care or services; reduce the number of visits in response to 
payment; or inappropriately discharge a patient receiving Medicare home 
health services as these would be violations of the CoPs and could also 
subject HHAs to program integrity measures.
    Final Decision: We are finalizing the functional points and 
functional impairment levels updates for CY 2024 as proposed, using CY 
2022 claims data (as of July 15, 2023). The updated OASIS functional 
points table and the table of functional impairment levels by clinical 
group for CY 2024 are listed in Tables B7 and B8, respectively.
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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:
    <bullet> Low comorbidity adjustment: There is a reported secondary 
diagnosis on the home health-specific comorbidity subgroup list that is 
associated with higher resource use.

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    <bullet> 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.
    <bullet> 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), 
we stated that we would continue to 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 proposed 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 proposed to update the comorbidity subgroups to 
include 22 low comorbidity adjustment subgroups as identified in Table 
B19 and 101 high comorbidity adjustment interaction subgroups as 
identified in Table B20 in the CY 2024 HH PPS proposed rule.
    We invited comments on the proposed updates to the low comorbidity 
adjustment subgroups and the high comorbidity adjustment interactions 
for CY 2024. These comments and our responses are summarized as 
follows.
    Comment: A commenter supported the proposed low comorbidity 
subgroups and the high comorbidity interactions. This commenter stated 
that the proposed low comorbidity subgroups achieve the goal of 
ensuring that payment is in alignment with the actual costs of 
providing care and the high comorbidity adjustment interaction 
subgroups acknowledge the impact of multiple diagnoses on care delivery 
complexity and cost.
    Response: We thank the commenter for their support.
    Comment: A commenter requested clarification on the number of 
proposed low comorbidity subgroups for CY 2024. This commenter noted 
that Table B19 included 22 subgroups, but the preamble language listed 
the number of subgroups as 21.
    Response: We thank the commenter for bringing this to our 
attention. The preamble language inadvertently stated that there were 
21 low comorbidity subgroups; however, the 22 subgroups listed in Table 
B19 are accurate. Furthermore, the number of low comorbidity subgroups 
remains 22 for this final rule.
    Comment: A commenter requested that CMS reassign diseases and 
disorders, as well as specific ICD-10 CM diagnosis codes, to different 
comorbidity subgroups and create new high comorbidity interactions. The 
commenter requested the following reassignments:
    <bullet> Include the Diabetes with mononeuropathy, E.41 codes in 
the Neurological 10 grouping.
    <bullet> Include rheumatic mitral valve diseases I05. codes and 
aortic rheumatic valve diseases I06 codes in the Heart 9 grouping.
    <bullet> Add a high comorbidity interaction for Circulatory 1 and 
Skin 4.
    <bullet> Add a high comorbidity interaction between Neurological 11 
and Skin 4.
    <bullet> Add a high comorbidity interaction between Skin 1, abscess 
and Skin 4.
    Response: We appreciate the commenter's review of these codes and 
suggested reassignments and may consider these changes in future 
rulemaking. As we stated in the CY 2020 final rule with comment period 
(84 FR 60510), and as described in the technical report ``Overview of 
the Home Health Groupings Model,'' the home health-specific comorbidity 
list is based on the principles of patient assessment by body systems 
and their associated diseases, conditions, and injuries. We used this 
process to develop categories of conditions that identify clinically 
relevant relationships associated with increased resource use. We 
understand the magnitude of clinical conditions and comorbidities, and 
the interactions that exist between them, in the Medicare home health 
population; however, we remind commenters that only those subgroups of 
diagnoses that represent more than 0.1 percent of periods of care and 
that have at least as high as the median resource use will receive a 
low comorbidity adjustment. We describe this method for determining 
statistical significance in the CY 2020 final rule with comment period 
(84 FR 60510). This is based on the knowledge that the average number 
of comorbidities in the aggregate becomes the standard within that 
population for the purpose of payment. However, because we still expect 
HHAs to report all secondary diagnoses that affect care planning, there 
will be comorbidity subgroups included in the home health-specific list 
that do not meet the criteria to receive an adjustment.
    Final Decision: We are finalizing the proposal to update the 
comorbidity adjustment subgroups and the high comorbidity adjustment 
interactions using CY 2022 home health data. For CY 2024, the final 
update to the comorbidity adjustment subgroups includes 22 low 
comorbidity adjustment subgroups as identified in Table B9 and 102 high 
comorbidity adjustment interaction subgroups as identified in Table 
B10. The final 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 <a href="https://www.cms.gov/Center/Provider-Type/Home-Health-Agency-HHA-Center">https://www.cms.gov/Center/Provider-Type/Home-Health-Agency-HHA-Center</a>.
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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 for the CY 2024 HH PPS proposed rule, we used CY 2022 home 
health claims data with linked OASIS data (as of March 17, 2023). These 
data were the most current and complete data available at the time of 
rulemaking. We stated that 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 and indicated that the proposed 
recalibrated case-mix weights would 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 B7 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 B11 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 final case-mix weights for CY 2024 are listed in Table B12 and 
will also be posted on the HHA Center web page \12\ upon display of 
this final rule.
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    \12\ HHA Center web page: <a href="https://www.cms.gov/Center/Provider-Type/Home-Health-Agency-HHA-Center">https://www.cms.gov/Center/Provider-Type/Home-Health-Agency-HHA-Center</a>.
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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 
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

[[Page 77726]]

data at the time of rulemaking, which is CY 2022 data (as of July 15, 
2023). 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 1.0124.
    We invited comments on the proposed CY 2024 case-mix weights, case-
mix weight budget neutrality factor and these are summarized as 
follows.
    Comment: A commenter expressed support for the annual recalibration 
of the case-mix weights using CY 2022 utilization data.
    Response: We thank the commenter for their support.
    Comment: Several commenters opposed recalibrating the PDGM case-mix 
weights for CY 2024. Some commenters expressed concern with the 
frequency of recalibration stating that annual updates create 
instability for home health agencies. Other commenters stated that CMS 
should delay recalibrating the case-mix weights until the impact of 
previous recalibrations on access and care has been reviewed. A 
commenter suggested that an independent analysis should be conducted to 
verify the reliability of the regression model used to set case-mix 
weights during a period of budget neutrality measurement. Lastly, a 
commenter requested transparency as to why and how CMS makes changes to 
the PDGM case-mix weights.
    Response: We recognize that commenters have had concerns regarding 
annual recalibration since we finalized this policy previously; 
however, we continue to believe that annual recalibration of the PDGM 
case-mix weights ensures that the case-mix weights reflect, as 
accurately as possible, current home health resource use, changes in 
utilization patterns, and reflects the types of patients currently 
receiving home health services. We believe that prolonging 
recalibration, rather than recalibrating annually, could lead to more 
significant variation in the case-mix weights than what is observed 
using the most recent utilization data. Therefore, we believe that 
utilizing CY 2022 data to recalibrate the CY 2024 case-mix weights is 
appropriate and do not agree that an independent analysis is necessary. 
Regarding the comment requesting transparency, we direct commenters to 
review the CY 2019 HH PPS final rule with comment period (83 FR 56502) 
for the finalized case-mix adjustment methodology, as well as the 
previously discussed steps we take to determine the case-mix weight for 
each of the 432 different PDGM payment groups which are outlined in 
this final rule.
    Comment: A few commenters requested that CMS analyze the cumulative 
impact of the proposed recalibration of the PDGM case-mix weights, as 
well as the updates to the wage index prior to finalizing any changes.
    Response: It is important to note that both the recalibration of 
the PDGM case-mix weights and updates to the HH PPS are implemented in 
a budget neutral manner so that changes to the case-mix weights, 
functional impairment levels, comorbidity adjustments, as well as 
updated wage data do not impact payments in the aggregate.
    Comment: A commenter had general concerns regarding the diagnosis 
codes included in the clinical grouping case-mix variable. This 
commenter stated that there continues to be no assignment of many 
diagnoses that drive home health need, citing non-specific diagnosis 
codes such as debility and weakness. The commenter stated that while 
there may be no specific medical diagnoses causing these conditions, 
the patient would still greatly benefit from home health care. The 
commenter recommended that CMS allow codes such as R29.6 Repeated 
falls, R54 Age related physical debility, R26.89 Abnormalities of gait, 
M62.81 Muscle weakness, and generalized R41.82 Altered Mental Status 
for home health services.
    Response: As we stated in the CY 2019 HH PPS final rule with 
comment period (83 FR 56473), we believe that the majority of the R-
codes (codes that describe signs and symptoms, as opposed to diagnoses) 
are not appropriate as principal diagnosis codes for grouping home 
health periods into clinical groups. We believe that the use of 
symptoms, signs, and abnormal clinical and laboratory findings would 
make it difficult to meet the requirements of an individualized plan of 
care as required at 42 CFR 484.60. Likewise, we believe that clinically 
it is important for home health providers to have a clear understanding 
of the patients' diagnoses in order to safely and effectively furnish 
home health services. Interventions and treatment aimed at mitigating 
signs and symptoms of a condition may vary depending on the cause. 
Anecdotally, we have heard that a home health referral may be 
nonspecific or that a physician or allowed practitioner may be in the 
process of determining a more definitive diagnosis. However, with 
respect to patient safety and quality of care, we believe it is 
important for a clinician to investigate the cause of the signs and/or 
symptoms for which the referral was made. This may involve calling the 
referring physician or allowed practitioner to gather more information. 
We note that HHAs are required under the home health CoPs at Sec.  
484.60 to participate in care coordination to assure the identification 
of patient needs and factors that could affect patient safety and 
treatment efficacy. ICD-10-CM coding guidelines are clear that R-codes 
are to be used when no more specific diagnosis can be made even after 
all the facts bearing on the case have been investigated. Therefore, 
while these codes should not be used as a principal diagnosis for the 
provision of home health services, they can be reported as secondary 
diagnoses to provide a more complete clinical picture of the patient. 
By the time the patient is referred to home health and meets the 
qualifications of eligibility, we would expect that a more definitive 
code would substantiate the need for services.
    Final Decision: We are finalizing the proposal to recalibrate the 
HH PPS case-mix weights for CY 2024. The proposed recalibrated case-mix 
weights were updated based on more complete CY 2022 claims data (as of 
July 15, 2023) for this final rule. We did not receive any comments on 
the proposed case-mix weight budget neutrality factor. Therefore, we 
are finalizing the proposal to implement the changes to the PDGM case-
mix weights in a budget neutral manner by applying a case-mix budget 
neutrality factor to the CY 2024 national, standardized 30-day period 
payment rate. As stated previously, the final case-mix budget 
neutrality factor for CY 2024 will be 1.0124.
3. 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

[[Page 77727]]

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 proposed 
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 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 
proposed 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) 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 
proposed 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 proposed 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 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 
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 proposed 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 proposed to rebase and 
revise the home health market basket to reflect a 2021 base year.
(c) Derivation of the 2021-Based Home Health Market Basket Major Cost 
Weights
    We proposed to derive the major cost weights for the revised and 
rebased home health market basket 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 proposed to maintain our policy of using data from freestanding 
HHAs,

[[Page 77728]]

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 proposed 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. Each of the major cost categories and the residual 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 seven major cost categories derived 
from the Medicare cost report data. Unless otherwise specified, 
calculations are consistent with 2016 methodology.
(1) Total Medicare Allowable Costs
    We proposed 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 proposed 
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 proposed 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 proposed to calculate direct patient care wages and salaries by 
summing costs from Worksheet A, column 1, lines 16 through 25.
(ii) Overhead
    We proposed 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 proposed 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 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 proposed 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 proposed 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 
proposed 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.

[[Page 77729]]

(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 proposed 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 proposed 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 proposed 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 proposed 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 proposed 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 proposed 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 proposed 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 2021-based home health market 
basket for the given category.
    Finally, we proposed 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 B13 shows the major cost categories and their respective cost 
weights as derived from the Medicare cost reports.

[[Page 77730]]

[GRAPHIC] [TIFF OMITTED] TR13NO23.033

    The decrease in the wages and salaries cost weight of 0.9 
percentage point and the decrease in the 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 B14. 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] TR13NO23.034

    Additionally, the Medicare cost report data shows that decreased 
contract labor utilization has occurred over most occupational 
categories, including higher-paid specialties, 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 proposed 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 proposed 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 <a href="http://www.bea.gov/industry/io_annual.htm">http://www.bea.gov/industry/io_annual.htm</a>. 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.\13\ 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 proposed to 
inflate the detailed 2012 Benchmark I-O data forward to 2021 by 
applying the annual price changes for each year from the respective 
price proxies to the appropriate market basket cost categories that are 
obtained from the 2012 Benchmark I-O data. 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 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 2021-based home health market 
basket's ``All Other'' cost category (18.6 percent), yielding a 
Utilities cost weight

[[Page 77731]]

of 2.0 percent in the 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 while basing it on the 2007 
Benchmark I-O data (aged to 2016).
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    \13\ <a href="http://www.bea.gov/papers/pdf/IOmanual_092906.pdf">http://www.bea.gov/papers/pdf/IOmanual_092906.pdf</a>.
---------------------------------------------------------------------------

    Using this methodology, we proposed to derive eight detailed cost 
categories from the 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 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 B15 compares the cost categories and weights for the 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 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).
[GRAPHIC] [TIFF OMITTED] TR13NO23.035

(d) Selection of Price Proxies
    After developing the cost weights for the 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:
    <bullet> 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

[[Page 77732]]

are based on the Standard Occupational Classification System (SOC).
    <bullet> 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 (<a href="https://www.bls.gov/ppi/">https://www.bls.gov/ppi/</a>).
    <bullet> 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 (<a href="https://www.bls.gov/cpi/">https://www.bls.gov/cpi/</a>). 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:
    <bullet> 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.)
    <bullet> 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.
    <bullet> 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.
    <bullet> 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 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 
proposed for each cost category weight.
(e) 2021-Based Home Health Market Basket Price Proxies
    As part of the revising and rebasing of the home health market 
basket, we proposed to rebase and revise the home health blended Wages 
and Salaries index and the home health blended Benefits index. We 
proposed to use these blended indexes as price proxies for the Wages 
and Salaries and the Benefits categories of the 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 proposed 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 proposed to use a 
blended wage proxy because there is not a published wage proxy specific 
to the home health industry.
    We proposed 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 proposed 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 
<a href="http://www.bls.gov/oes/current/oes_tec.htm">http://www.bls.gov/oes/current/oes_tec.htm</a>.
    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 B16 compares the 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 B16 as ``n/a.''

[[Page 77733]]

[GRAPHIC] [TIFF OMITTED] TR13NO23.036

    We proposed to calculate total costs by occupation 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 B17 represent the wages and 
salaries blend weights for 2021, and the ECIs for each occupational 
category within the Wages and Salaries price proxy blend, as well as 
the 2016 weights. We note that the current ECI series also 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

[[Page 77734]]

social assistance services and lower weight for other service 
occupations.\14\
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    \14\ <a href="https://www.bls.gov/soc/2018/soc_2018_whats_new.pdf">https://www.bls.gov/soc/2018/soc_2018_whats_new.pdf</a>.
    [GRAPHIC] [TIFF OMITTED] TR13NO23.037
    
    [GRAPHIC] [TIFF OMITTED] TR13NO23.038
    
    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 2021-
based home health Wages and Salaries proxy blend is shown in Table B18. 
The annual increases in the wages and salaries price proxy is 0.3 
percentage point lower in 2021 and 2022 relative to the 2016-based 
price proxy, and the increases are equal in 2023 and 2024. The 
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 B17.

[[Page 77735]]

[GRAPHIC] [TIFF OMITTED] TR13NO23.039

(2) Benefits
    For measuring Benefits price growth in the 2021-based home health 
market basket, we proposed to apply applicable price proxies to the six 
occupational subcategories that are used for the Wages and Salaries 
price proxy blend. The six categories in Table B19 are the same as 
those in the 2016-based home health market basket and include the same 
occupational mix as listed in Table B17.
[GRAPHIC] [TIFF OMITTED] TR13NO23.040

    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 proposed 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 (29.7 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 2021-based home 
health Benefits proxy blend is shown in Table B20. 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.
[GRAPHIC] [TIFF OMITTED] TR13NO23.041


[[Page 77736]]


(3) Medical Supplies
    We proposed 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 proposed 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 we based the 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 proposed 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 proposed 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 proposed 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 proposed 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 proposed 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 proposed 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 


[…truncated; see source link]
Indexed from Federal Register on November 13, 2023.

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