Medicare Program; Calendar Year (CY) 2025 Home Health Prospective Payment System (HH PPS) Rate Update; HH Quality Reporting Program Requirements; HH Value-Based Purchasing Expanded Model Requirements; Home Intravenous Immune Globulin (IVIG) Items and Services Rate Update; and Other Medicare Policies, 88354-88485 [2024-25441]

Agencies

• Centers for Medicare & Medicaid Services
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 89, Number 216 (Thursday, November 7, 2024)]
[Rules and Regulations]
[Pages 88354-88485]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-25441]



[[Page 88353]]

Vol. 89

Thursday,

No. 216

November 7, 2024

Part II





Department of Health and Human Services





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Centers for Medicare & Medicaid Services





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42 CFR Parts 424, 483, and 484





Medicare Program; Calendar Year (CY) 2025 Home Health Prospective 
Payment System (HH PPS) Rate Update; HH Quality Reporting Program 
Requirements; HH Value-Based Purchasing Expanded Model Requirements; 
Home Intravenous Immune Globulin (IVIG) Items and Services Rate Update; 
and Other Medicare Policies; Final Rule

Federal Register / Vol. 89, No. 216 / Thursday, November 7, 2024 / 
Rules and Regulations

[[Page 88354]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 424, 483, and 484

[CMS-1803-F]
RIN 0938-AV28


Medicare Program; Calendar Year (CY) 2025 Home Health Prospective 
Payment System (HH PPS) Rate Update; HH Quality Reporting Program 
Requirements; HH Value-Based Purchasing Expanded Model Requirements; 
Home Intravenous Immune Globulin (IVIG) Items and Services Rate Update; 
and Other Medicare Policies

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 will set forth routine updates to the Medicare 
home health payment rates; the payment rate for the disposable negative 
pressure wound therapy (dNPWT) devices; and the intravenous immune 
globulin (IVIG) items and services payment rate for CY 2025 in 
accordance with existing statutory and regulatory requirements. In 
addition, it finalizes changes to the Home Health Quality Reporting 
Program (HH QRP) requirements and provides an update on potential 
approaches for integrating health equity in the Expanded Health Value 
Based Purchasing (HHVBP) Model. It also finalizes a new standard for an 
acceptance-to-service policy in the HH conditions of participation 
(CoPs). Lastly, it updates provider and supplier enrollment 
requirements and changes to the long-term care reporting requirements 
for acute respiratory illnesses.

DATES: These regulations are effective on January 1, 2025.

FOR FURTHER INFORMATION CONTACT: Brian Slater, (410) 786-5229, for home 
health and home IVIG payment inquiries.
    For general information about the Home Health Prospective Payment 
System (HH PPS), send your inquiry via email to 
[email protected].
    For general information about the IVIG Items and Services Payment, 
send your inquiry via email to [email protected].
    For information about the Home Health Quality Reporting Program (HH 
QRP), send your inquiry via email to [email protected].
    For more information about the expanded Home Health Value-Based 
Purchasing Model, please visit the Expanded HHVBP Model web page at 
https://innovation.cms.gov/innovation-models/expanded-home-health-value-based-purchasing-model.
    Frank Whelan, (410) 786-1302, for Medicare provider and supplier 
enrollment inquiries.
    Mary Rossi-Coajou at [email protected] or Molly 
Anderson at [email protected], for more information about the 
home health conditions of participation (HH CoPs).
    Kim Roche at [email protected] or Diane Corning at 
[email protected] for information about long term care facility 
acute respiratory illness reporting.

SUPPLEMENTARY INFORMATION: 

Table of Contents

I. Executive Summary and Issuance of the Final 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. CY 2025 Final Rule Payment Adjustments Under the HH PPS
    D. CY 2025 Home Health Low Utilization Payment Adjustment (LUPA) 
Thresholds, Functional Impairment Levels, Comorbidity Sub-Groups, 
Case-Mix Weights, and Reassignment of Specific ICD-10-CM Codes Under 
the PDGM
III. Home Health Quality Reporting Program (HH QRP)
    A. Background and Statutory Authority
    B. Summary of the Provision of This Final Rule
    C. Quality Measures Currently Adopted for the CY 2024 HH QRP
    D. Proposal To Collect Four New Items as Standardized Patient 
Assessment Data Elements and Modify One Item Collected as a 
Standardized Patient Assessment Data Element Beginning With the CY 
2027 HH QRP
    E. Proposal To Update OASIS All-Payer Data Collection
    F. Form, Manner, and Timing of Data Submission Under the HH QRP
    G. HH QRP Quality Measure Concepts Under Consideration for 
Future Years--Request for Information (RFI)
IV. The Expanded Home Health Value-Based Purchasing (HHVBP) Model
    A. Background
    B. Request for Information on Future Performance Measure 
Concepts for the Expanded HHVBP Model
    C. Future Approaches to Health Equity in the Expanded HHVBP 
Model
    D. Social Risk Factors
    E. Approaches to a Potential Health Equity Adjustment for the 
Expanded HHVBP Model
    F. Other Health Equity Measures
V. Medicare Home Intravenous Immune Globulin (IVIG) Items and 
Services
    A. General Background
    B. Scope of Expanded IVIG Benefit
    C. Home IVIG Administration Items and Services Payment
    D. Home IVIG Items and Services Payment Rate
VI. Home Health Agency Condition of Participation (CoP) Changes and 
Long Term Care (LTC) Facility Requirements for Acute Respiratory 
Illness Reporting
    A. Home Health Agency CoP Changes
    B. Long-Term Care (LTC) Requirements for Acute Respiratory 
Illness Reporting
VII. Provider Enrollment--Provisional Period of Enhanced Oversight
    A. Background
    B. Provisional Period of Enhanced Oversight (PPEO)
VIII. Collection of Information Requirements
    A. Statutory Requirement for the Solicitation of Comments
    B. Information Collection Requirements (ICRs)
IX. 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

I. Executive Summary and Issuance of the Final 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 CY 2025 payment rates for home health 
agencies (HHAs) and the CY 2025 payment rate for disposable negative 
pressure wound therapy (dNPWT) devices. This rule finalizes a crosswalk 
for mapping the Outcome and Assessment Information Set-D (OASIS-D) data 
elements to the equivalent OASIS-E data elements for use in the 
methodology to analyze the difference between assumed versus actual 
behavior change on estimated aggregate expenditures and finalizes a 
permanent adjustment to the CY 2025 home health base payment rate. In 
addition, this rule finalizes the recalibrated PDGM case-mix weights 
and updates the low-utilization payment adjustment (LUPA) thresholds, 
functional impairment levels, and

[[Page 88355]]

comorbidity adjustment subgroups under section 1895(b)(4)(A)(i) and 
(b)(4)(B) of the Act for 30-day periods of care in CY 2025; finalizes 
the proposal to adopt the most recent Office of Management and Budget 
(OMB) Core-Based Statistical Area (CBSA) delineations for the home 
health wage index; and finalizes an occupational therapy (OT) LUPA add-
on factor and updates the physical therapy (PT), speech-language 
pathology (SLP), and skilled nursing (SN) LUPA add-on factors. 
Additionally, this rule updates the CY 2025 fixed-dollar loss ratio 
(FDL) for outlier payments (so that outlier payments as a percentage of 
estimated total payments are projected 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 updated policies. We are 
finalizing a proposal to add four new assessment items and modify one 
assessment item on the OASIS, update the removal of the suspension of 
OASIS all payer data collection and summarize public feedback on future 
HH QRP quality measure (QM) concepts.
c. Expanded Home Health Value-Based Purchasing (HHVBP) Model
    In accordance with the statutory authority at section 1115A of the 
Act, we are doing the following for the expanded HHVBP Model: (1) 
providing an update on potential approaches for integrating health 
equity that are being considered; and (2) summarizing comments we 
received on a request for information (RFI) related to potential future 
performance measure concepts.
d. Home Intravenous Immune Globulin (IVIG) Items and Services
    In section V.D.1. of this rule, we finalize the rate for the CY 
2025 IVIG items and services payment under the home intravenous immune 
globulin (IVIG) benefit.
e. Home Health CoP Changes
    In section VI.A. of this final rule, we are finalizing a new 
standard at Sec.  484.105(i) that will require HHAs to develop, 
implement, and maintain an acceptance-to-service policy that is applied 
consistently to each prospective patient referred for home health care. 
As finalized, the policy must address, at minimum, the following 
criteria related to the HHA's capacity to provide patient care: the 
anticipated needs of the referred prospective patient, the HHA's case 
load and case mix, the HHA's staffing levels, and the skills and 
competencies of the HHA staff. We also finalized a policy that HHAs 
will be required to make specified information available to the public 
that is reviewed whenever services are changed, and no less often than 
annually.
f. Provider and Supplier Enrollment Requirements
    Section 1866(j)(3)(A) of the Act states that the Secretary shall 
establish procedures to provide for a provisional period of between 30 
days and 1 year during which new providers and suppliers--as the 
Secretary determines appropriate, including categories of providers or 
suppliers--will be subject to enhanced oversight. We are finalizing our 
proposal to expand the definition of ``new provider or supplier'' in 
Sec.  424.527(a) (solely for purposes of applying a provisional period 
of enhanced oversight) to include providers and suppliers that are 
reactivating their Medicare enrollment and billing privileges.
g. Long-Term Care (LTC) Facility Requirements for Acute Respiratory 
Illness Reporting
    The current LTC requirements for reporting COVID-19 related data 
expire on December 31, 2024, except for reporting COVID-19 resident and 
staff vaccination status. Given the utility of LTC facility data, we 
finalized a requirement to replace these requirements with streamlined 
continued data reporting requirements for certain respiratory 
illnesses. We are also finalizing a requirement that LTC facilities 
submit additional, related data elements that could be activated in the 
event of a future acute respiratory illness public health emergency 
(PHE). We are not finalizing our proposal to increase data reporting if 
a significant threat for a PHE for an acute infectious illness exists.
2. Summary of the Provisions of This Final Rule
a. Home Health Prospective Payment System (HH PPS)
    In section II.B.1. of this final rule, we discuss comments related 
to the monitoring and data analysis on PDGM utilization.
    In section II.C.1 of this final rule, we finalize a permanent 
adjustment to the base payment rate under the HH PPS. Additionally, we 
finalize a crosswalk for mapping the OASIS-D data elements to the 
equivalent OASIS-E data elements for use in the methodology to analyze 
the difference between assumed versus actual behavior change on 
estimated aggregate expenditures.
    In section II.D. of this final rule, we recalibrate the CY 2025 
home health LUPA thresholds, case-mix weights, and co-morbidity 
subgroups. Additionally, we discuss providers' suggestions regarding 
the reassignment of specific ICD-10-CM diagnosis codes under the PDGM.
    In section II.E. of this final rule, we finalize a policy updating 
the home health wage index using the new labor market delineations from 
the July 21, 2023, OMB Bulletin No. 23-01 based on data collected from 
the 2020 Decennial Census. This section also includes the CY 2025 
national, standardized 30-day period final payment rate, the final CY 
2025 national per-visit payment amounts updated by the home health 
payment update percentage, and the final OT, PT, SLP, and SN LUPA add-
on factors. The final home health payment update percentage for CY 2025 
is 2.7 percent. Additionally, this rule finalizes the CY 2025 FDL ratio 
to ensure that aggregate outlier payments do not exceed 2.5 percent of 
the total aggregate payments, as required by section 1895(b)(5)(A) of 
the Act.
    In section II.F.4. of this final rule, we finalize the CY 2025 
payment rate for dNPWT devices.
b. Home Health Quality Reporting Program (HH QRP)
    In section III. of this final rule, we finalize the collection of 
four new items as standardized patient assessment data elements in the 
social determinants of health (SDOH) category and modify one item 
collected as a standardized patient assessment data element in the SDOH 
category beginning with the CY 2027 HH QRP. The four assessment items 
finalized for collection are: one Living Situation item, two Food 
items, and one Utilities item. We also finalize a policy to modify the 
current Transportation item beginning with the CY 2027 HH QRP. We are 
also proposed an update to the removal of the suspension of OASIS all-
payer data collection to change all-payer data collection to begin with 
the start of care OASIS data collection timepoint instead of discharge 
timepoint. Lastly, we seek input on future HH QRP measure concepts.
c. Expanded Home Health Value Based Purchasing (HHVBP) Model
    In section IV. of this final rule, we summarize comments received 
on an RFI related to future measure concepts for the expanded HHVBP 
Model. We are also including an update to the RFI, ``Future Approaches 
to Health Equity in the Expanded HHVBP Model,'' that was

[[Page 88356]]

published in the CY 2023 HH PPS final rule (87 FR 66874, November 4, 
2022) and subsequently updated in the CY 2024 HH PPS final rule (88 FR 
77687, November 13, 2023).
d. Home Intravenous Immune Globulin (IVIG) Items and Services
    In section V.D.1. of this final rule, we finalize the CY 2025 IVIG 
items and services payment rate under the home intravenous immune 
globulin (IVIG) benefit.
e. Home Health CoP Changes
    In section VI.A. of this final rule, we finalized a new standard at 
Sec.  484.105(d) that will require HHAs to develop, implement, and 
maintain an acceptance-to-service policy that is applied consistently 
to each prospective patient referred for home health care. We have also 
finalized a requirement that the policy must address, at minimum, the 
following criteria related to the HHA's capacity to provide patient 
care: the anticipated needs of the referred prospective patient, the 
HHA's case load and case mix, the HHA's staffing levels, and the skills 
and competencies of the HHA staff. We also finalized a requirement that 
HHAs make specified information available to the public that is 
reviewed at least annually. In the proposed rule, we sought public 
comments on other factors that influence the patient referral and 
intake processes. In this final rule, we summarize comments received.
f. Provider and Supplier Enrollment Requirements
    Section 1866(j)(3)(A) of the Act states that the Secretary may 
establish procedures to provide for a provisional period of between 30 
days and 1 year during which new providers and suppliers--as the 
Secretary determines appropriate, including categories of providers or 
suppliers--will be subject to enhanced oversight. We are finalizing our 
proposal to expand the definition of ``new provider or supplier'' 
(solely for purposes of applying a PPEO) to include providers and 
suppliers that are reactivating their Medicare enrollment and billing 
privileges.
g. Long-Term Care (LTC) Requirements for Acute Respiratory Illness 
Reporting
    The current LTC requirements for reporting COVID-19 related data 
expire on December 31, 2024, except for reporting COVID-19 resident and 
staff vaccination status. Given the utility of LTC facility data, we 
finalized to replace these requirements with streamlined continued data 
reporting requirements for certain respiratory illnesses. We are also 
finalizing additional, related data elements that could be activated in 
the event of a future acute respiratory illness PHE. We are not 
finalizing our proposal to increase data reporting if a significant 
threat for a PHE for an acute infectious illness exists.
3. Summary of Costs, Transfers, and Benefits
[GRAPHIC] [TIFF OMITTED] TR07NO24.000


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[GRAPHIC] [TIFF OMITTED] TR07NO24.001

B. Issuance of the Proposed Rule

    The proposed rule, titled ``Medicare Program; Calendar Year (CY) 
2025 Home Health Prospective Payment System (HH PPS) Rate Update; HH 
Quality Reporting Program Requirements; HH Value-Based Purchasing 
Expanded Model Requirements; Home Intravenous Immune Globulin (IVIG) 
Items and Services Rate Update; and Other Medicare Policies,'' appeared 
in the Federal Register on July 3, 2024 (89 FR 55312) (hereinafter 
referred to as the CY 2025 HH PPS proposed rule or July 2024 proposed 
rule).
    The proposed rule set forth proposed payment and policy changes to 
the Medicare Home Health prospective payment system for CY 2025, 
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 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), 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. In the November 9, 2006, Federal Register (71 FR 
65935), we issued a final rule 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

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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 will 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) (Pub. L. 117-328) amended section 1834(s)(3)(A) of the 
Act to require that, beginning with 2024, the separate payment for 
furnishing negative pressure wound therapy (NPWT) be for just the 
device and not for nursing and therapy services. Payment for nursing 
and therapy services are to be included as part of payments under the 
HH PPS. The separate payment for 2024 was required to be equal to the 
supply price used to determine the relative value for the service under 
the Medicare Physician Fee Schedule (as of January 1, 2022) for the 
applicable disposable device updated by the percentage increase in the 
Consumer Price Index for All Urban Consumers (CPI-U). The separate 
payment for 2025 and each subsequent year is to be the payment amount 
for the previous year updated by the percentage increase in the CPI-U 
(United States city average) for the 12-month period ending in June of 
the previous year reduced by the productivity adjustment as described 
in section 1886(b)(3)(B)(xi)(II) of the Act for such year. The CAA, 
2023 also added section 1834(s)(4) of the Act to require that beginning 
with 2024, as part of submitting claims for the separate payment, the 
Secretary shall accept, and process claims submitted using the type of 
bill that is most commonly used by home health agencies to bill 
services under a home health plan of care.
2. Current System for Payment of Home Health Services
    For home health periods of care beginning on or after January 1, 
2020, Medicare makes payment under the HH PPS on the basis of a 
national, standardized 30-day period payment rate that is adjusted for 
case-mix and area wage differences in accordance with section 
51001(a)(1)(B) of the BBA of 2018. The national, standardized 30-day 
period payment rate includes payment for the six home health 
disciplines (skilled nursing, home health aide, physical therapy, 
speech-language pathology, occupational therapy, and medical social 
services). Payment for non-routine supplies (NRS) is also part of the 
national, standardized 30-day period rate. Durable medical equipment 
(DME) provided as a home health service, as defined in section 1861(m) 
of the Act, is paid the fee schedule amount or is paid through the 
competitive bidding program and such payment is not included in the 
national, standardized 30-day period payment amount. Additionally, the 
30-day period payment rate does not include payment for certain 
injectable osteoporosis drugs and disposable negative pressure wound 
therapy (dNPWT) devices, but such drugs and devices 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 dNPWT devices.
    To better align payment with patient care needs and to better 
ensure that clinically complex and ill beneficiaries have adequate 
access to home health care, in the CY 2019 HH PPS final rule with 
comment period (83 FR 56406), we finalized case-mix methodology 
refinements through the Patient-Driven Groupings Model (PDGM) for home 
health periods of care beginning on or after January 1, 2020. The PDGM 
did not change eligibility or coverage criteria for Medicare home 
health services, and as long as the individual meets the criteria for 
home health services as described at 42 CFR 409.42, the individual can 
receive Medicare home health services, including therapy services. For 
more information about the role of therapy services under the PDGM, we 
refer readers to the Medicare Learning Network (MLN) Matters article 
SE20005 available at https://www.cms.gov/regulations-and-guidanceguidancetransmittals2020-transmittals/se20005. To adjust for 
case-mix for 30-day periods of care beginning on and after January 1, 
2020, the HH PPS uses a 432-category case-mix classification system to 
assign patients to a home health resource group (HHRG) using patient

[[Page 88359]]

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 1. 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).
[GRAPHIC] [TIFF OMITTED] TR07NO24.002

B. Monitoring the Effects of the Implementation of PDGM

1. Routine PDGM Monitoring
    The CY 2025 HH PPS proposed rule included analysis of Medicare home 
health benefit utilization, including 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

[[Page 88360]]

any therapy visits, nursing visits, and/or aide/social worker visits. 
We also included monitoring of home health visits using 
telecommunications technology and remote patient monitoring, which we 
began collecting on claims submitted voluntarily beginning January 1, 
2023, and which was required beginning July 1, 2023.
    Comment: Overall, commenters discussed the home health utilization 
trends presented in the monitoring concurrently with comments regarding 
access to the benefit and generally stated that they believe a decline 
in utilization is not related to a reduced need for home health 
services. These commenters encouraged CMS to develop policies that 
ensure that the PDGM does not continue to affect access to care as 
indicated by these declining utilization trends. A commenter also 
suggested CMS expand data collection to include geographic, racial, 
ethnic, socio-economic, sexual orientation, and gender identity to 
highlight disparities in home health care services.
    Response: We will continue to monitor and analyze home health 
trends and vulnerabilities within the home health payment system and 
appreciate the commenter's suggestion for additional monitoring. We 
respond to comments discussing declining trends in utilization as they 
relate to access to care in our discussion in section B.1.f. of this 
final rule, and refer readers to that discussion.

C. CY 2025 Final Rule Payment Adjustments Under the HH PPS

1. Finalized Behavior Assumption Adjustments Under the HH PPS
a. Background
    As discussed in section II.A.1. of this final rule, starting in CY 
2020, the Secretary was required by section 1895(b)(2)(B) of the Act to 
change the unit of payment under the HH PPS from a 60-day episode of 
care to a 30-day period of care. CMS was also required to make 
assumptions about behavior changes that could occur as a result of the 
implementation of the 30-day unit of payment and the case-mix 
adjustment factors that eliminated the use of therapy thresholds. In 
the CY 2019 HH PPS final rule with comment period (83 FR 56455), we 
finalized three behavior change assumptions which were also described 
in the CY 2022 and 2023 HH PPS rules (86 FR 35890, 87 FR 37614, and 87 
FR 66795 through 66796). In the CY 2020 HH PPS final rule with comment 
period (84 FR 60519), we included these behavioral change assumptions 
in the calculation of the 30-day budget neutral payment amount for CY 
2020, finalizing a negative 4.36 percent behavior change assumption 
adjustment (``assumed behaviors''). We did not propose any changes for 
CYs 2021 and 2022 relating to the behavior assumptions finalized in the 
CY 2019 HH PPS final rule with comment period, or to the negative 4.36 
percent behavior change assumption adjustment, finalized in the CY 2020 
HH PPS final rule with comment period.
    In the CY 2023 HH PPS final rule (87 FR 66796), we stated, based on 
our annual monitoring at that time, the three assumed behavior changes 
did occur as a result of the implementation of the PDGM and that other 
behaviors, such as changes in the provision of therapy and changes in 
functional impairment levels also occurred. We also reminded readers 
that in the CY 2020 HH PPS final rule with comment period (84 FR 
60513), we stated we interpret actual behavior changes to encompass 
both behavior changes that were previously outlined as assumed by CMS, 
and other behavior changes not identified at the time the budget-
neutral 30-day payment rate for CY 2020 was established. In the CY 2023 
HH PPS final rule (87 FR 66796), we provided supporting evidence that 
indicated the number of therapy visits declined in CYs 2020 and 2021, 
as well as a slight decline in therapy visits beginning in CY 2019 
after the finalization of the removal of therapy thresholds, but prior 
to implementation of the PDGM. In section II.B.1. of the CY 2025 HH PPS 
proposed rule (89 FR 55318), our analysis continued to show overall the 
actual 30-day periods are similar to the simulated 30-day periods and 
there continues to be a decline in therapy visits, indicating that HHAs 
changed their behavior to reduce therapy visits. Although the analysis 
demonstrates evidence of individual behavior changes (for example, in 
the volume of visits for LUPAs, therapy sessions, etc.), we use the 
entirety of the behaviors in order to calculate estimated aggregate 
expenditures. The law instructs us to ensure that estimated aggregate 
expenditures under the PDGM are equal to the estimated aggregate 
expenditures that otherwise will have been made under the prior system.
    Section 4142(a) of the CAA, 2023 required CMS to present, to the 
extent practicable, a description of the actual behavior changes 
occurring under the HH PPS from CYs 2020-2026. This subsection of the 
CAA, 2023 also required CMS to provide datasets underlying the 
simulated 60-day episodes and discuss and provide time for stakeholders 
to provide input and ask questions on the payment rate development for 
CY 2023. CMS complied with these requirements by posting online both 
the supplemental limited data set (LDS) and descriptive files and the 
description of actual behavior changes that affected CY 2023 payment 
rate development. Additionally, on March 29, 2023, CMS conducted a 
webinar entitled ``Medicare Home Health Prospective Payment System (HH 
PPS) Calendar Year (CY) 2023 Behavior Change Recap, 60-Day Episode 
Construction Overview, and Payment Rate Development.'' The webinar was 
open to the public and discussed the actual behavior changes that 
occurred upon implementation of the PDGM, our approach used to 
construct simulated 60-day episodes using 30-day periods, payment rate 
development for CY 2023, and information on the supplemental data files 
containing information on the simulated 60-day episodes and actual 30-
day periods used in calculating the permanent adjustment to the payment 
rate. Materials from the webinar, including the presentation and the CY 
2023 descriptive statistics from the supplemental LDS files, containing 
information on the number of simulated 60-day episodes and actual 30-
day periods in CY 2021 that were used to construct the permanent 
adjustment to the payment rate, as well as information such as the 
number of episodes and periods by case-mix group, case-mix weights, and 
simulated payments, can be found on the Home Health Patient-Driven 
Groupings Model web page at https://www.cms.gov/medicare/medicare-fee-for-service-payment/homehealthpps/hh-pdgm.
b. Method To Annually Determine the Impact of Differences Between 
Assumed Behavior Changes and Actual Behavior Changes on Estimated 
Aggregate Expenditures
    In the CY 2023 HH PPS final rule (87 FR 66804), we finalized the 
methodology to evaluate the impact of the differences between assumed 
and actual behavior changes on estimated aggregate expenditures. In the 
CY 2024 HH PPS final rule (88 FR 77687 through 77688), we provided an 
overview of the methodology with detailed instructions for each step. 
The overall methodology as finalized remains the same for evaluating 
the impact of behavior changes as required by law; however, due to an 
update of the Outcome and Assessment Information Set (OASIS) 
instrument, we need to update two minor technical parts and in the CY 
2025 proposed rule, proposed to add new assumptions in the first step 
(creating simulated 60-day episodes from 30-day periods). These new

[[Page 88361]]

assumptions are described in this section.
    Section 1895(b)(3)(B)(v) of the Act requires HHAs to report certain 
quality data. As described in regulation at 42 CFR 484.250(a), this 
data is required to be reported using the OASIS instrument. Under the 
prior 153-group system (and the first three years for assessments 
associated with the PDGM completed prior to CY 2023), HHAs submitted 
the OASIS-D version. However, OMB approved an updated version of the 
OASIS instrument, OASIS-E, on November 30, 2022, effective January 1, 
2023. Thus, OASIS-E is the current version of the OASIS instrument used 
in the PDGM. The valid OMB control number for this information 
collection is 0938-1279.
    There are 13 items from the OASIS-D used in the 153-group system 
that are included in the OASIS-E; however, the responses for these 
items are now only recorded at the start of care (SOC) or resumption of 
care (ROC) assessments in the OASIS-E and not at all for OASIS-E 
follow-up assessments as shown in the following figure 2.
[GRAPHIC] [TIFF OMITTED] TR07NO24.003

    Three items in the OASIS-E differ slightly from the OASIS-D by 
incorporating more specific questions and responses than in the OASIS-
D. These three items, as shown in figure 3, ask about therapies 
(M1030), vision (M1200), and the frequency of pain interfering with 
activity (M1242). Additionally, these items are only asked at SOC/ROC 
and not at follow-up in the OASIS-E.

[[Page 88362]]

[GRAPHIC] [TIFF OMITTED] TR07NO24.004

    To continue with our finalized methodology and create simulated 60-
day episodes under the 153-group case mix system from 30-day periods 
under the PDGM, we need to impute the OASIS-D responses when we only 
have an OASIS-E available. For each of the three items, we considered 
the clinical relationship between the responses in the OASIS-E items 
that differ from the OASIS-D items. CMS also considered the response 
distribution between the OASIS-D and OASIS-E items when creating the 
mapping of the responses.
    CMS proposed the following two assumptions to address the changes 
from the OASIS-D to the OASIS-E to continue to create simulated 60-day 
episodes from 30-day periods.
     If the simulated 60-day episode matches to a SOC or ROC 
assessment then we proposed to not impute the 13 items. If the 
simulated 60-day episode matches to a follow-up assessment, then we 
proposed to look back for the most recent 30-day period that is linked 
to a SOC or ROC assessment and impute the 13 responses for follow-up 
using the responses at the most recent SOC or ROC assessment. We 
proposed that we would limit the look-back period to the beginning of 
the calendar year that precedes the calendar year for the claim. For 
example, for a simulated 60-day episode with a follow-up assessment on 
June 1, 2023, we would look back for a 30-day period linked to a SOC or 
ROC assessment that began on or after January 1, 2022. If we cannot 
find a SOC or ROC assessment in that time period, we proposed to 
exclude the claim from analysis because we would not have sufficient 
timely data to impute responses.
     If the simulated 60-day episode matches to an OASIS-D 
assessment, then we proposed to use the OASIS-D for responses. If the 
simulated 60-day episode matches to an OASIS-E assessment, we proposed 
applying the following mapping for the therapies, vision, and pain 
items to impute responses as these responses are required for accurate 
payment calculation under the prior 153-group system. We also proposed 
applying the look-back period (that is, beginning of the calendar year 
that precedes the calendar year for the claim) as described in the 
assumption above, when necessary, when mapping claims.

[[Page 88363]]

[GRAPHIC] [TIFF OMITTED] TR07NO24.005

    Note, if an OASIS-E assessment has a response of ``no'' to all 
three items (O0110H--IV medication, K0520--Parenteral/IV feeding, and 
K0520--Feeding Tube), as shown in figure 5, then the mapping for M1030 
would be a response of ``none of the above''.
[GRAPHIC] [TIFF OMITTED] TR07NO24.006


[[Page 88364]]


    There was one pain item on the OASIS-D (M1242--Frequency of Pain 
Interfering with patient's activity or movement) used for calculating 
payments. There are three pain related items on the OASIS-E (J0510--
pain effect on sleep, J0520--pain interference with therapy activities, 
and J0530--pain interference with day-to-day activities) that 
correspond to the one OASIS-D pain item used for calculating payments. 
Therefore, we stated that we believed using the response from J0510, 
J0520, or J0530 that reflects the maximum severity would be the most 
appropriate for mapping back to the OASIS-D. For example, if J0510 
(pain effect on sleep) has a response of ``rarely'', J0520 (pain 
interference with therapy activities) has a response of ``frequently'', 
and J0530 (pain interference with day-to-day activities) has a response 
of ``occasionally'', then we would use the response from J0520 
(``frequently'') for mapping as this is the most severe response. 
Figure 6 shows the proposed mapping based on the maximum severity 
response for each of the three pain items.
[GRAPHIC] [TIFF OMITTED] TR07NO24.007

    As the overall methodology was finalized in the CY 2023 HH PPS 
final rule (87 FR 66804), the two proposed assumptions described 
previously are simply technical updates based on the updated OASIS 
instrument 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 for assessing behavior 
changes as required by law. We refer readers to the CY 2024 HH PPS 
final rule (88 FR 77687 through 77688) for an overview of the overall 
methodology with detailed instructions for each step. We received a few 
comments on the proposed assumptions related to mapping of the OASIS-E 
items.
    Comment: A commenter supported the proposed assumptions. Another 
commenter expressed concerns related to the difference in the versions 
of questions used for mapping and a potential two-year lookback period. 
While the commenter did not present an alternative for mapping the 
three items missing from OASIS-E, the commenter did recommend a 
narrower lookback period of no more than three months.
    Response: We appreciate the commenter's thoughtful review and 
recommendations. We carefully reevaluated the crosswalk and found a 
three-month lookback period could significantly decrease the number of 
claims available for analysis, as well as skew the data to potentially 
more clinically severe patients, for example, this would generally 
limit the data to those patients who are discharged after an inpatient 
admission directly to home health care. A significant decrease in the 
total number of claims or in a particular type of claim (for example, 
community late) may not fully represent the population of home health 
patients. However, using an almost two-year look-back period for an 
assessment may not provide the most updated functional status of a 
beneficiary for the claim being analyzed, as a patient's functional 
impairment status may have changed (increased or decreased) in a longer 
look-back period. Balancing the need for adequate and unbiased data 
with the need for up-to-date data, we evaluated using a 12-month look-
back period and found this timeframe provided the most complete and 
accurate data possible. It provides a sufficient number of claims while 
also allowing for the use of more updated assessment data than would 
have been used in a 24-month look-back period.
    Final Decision: After consideration of the public comments and 
reevaluation of the proposed timeframe, we are finalizing the following 
assumptions for the OASIS-D to OASIS-E crosswalk:
     If the simulated 60-day episode matches to a SOC or ROC 
assessment then we will not impute the 13 items. If the simulated 60-
day episode matches to an OASIS-E follow-up assessment, then we will 
look back for the most recent 30-day period that is linked to a SOC or 
ROC assessment and impute the 13 responses for follow-up using the 
responses at the most recent SOC or ROC assessment. We will limit the 
look-back period to 12-months. For example, a simulated 60-day episode 
that began on June 1, 2023, and linked to a follow-up assessment will 
be limited to a 30-day period that ended on or after June 1, 2022, and 
linked to a SOC or ROC assessment. If we cannot find a SOC or ROC 
assessment in that time period, we will exclude the claim from 
analysis.
     If the simulated 60-day episode matches to an OASIS-D 
assessment, then we will use the OASIS-D for the three items (therapies 
(M1030), vision (M1200), and the frequency of pain interfering with 
activity (M1242)) responses. If the simulated 60-day episode matches to 
an OASIS-E

[[Page 88365]]

assessment, we will apply the mapping for the therapies, vision, and 
pain items as shown in figures 4-6 to impute responses as these 
responses are required for accurate payment calculation under the prior 
153-group system. When necessary, we will also apply the same 12-month 
look-back period as described in the previous assumption.
c. Calculating Permanent and Temporary Payment Adjustments
    To offset prospectively for such increases or decreases in 
estimated aggregate expenditures resulting from 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 an 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 calculated 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 used 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. We refer readers to the CY 2024 HH PPS final 
rule (88 FR 77689 through 77694) for analysis for CYs 2020 through 2022 
claims. Additionally, at the end of this section we provide a summary 
table for the permanent adjustment and temporary dollar amounts 
calculated for each year.
    Comment: Several commenters continue to oppose the behavior 
adjustment methodology finalized in the CY 2023 HH PPS final rule and 
repeated objections discussed in the CY 2023 HH PPS final rule and CY 
2024 HH PPS final rule, stating that they believe the methodology 
violates the Social Security Act and performs an unauthorized rebasing 
of the 30-day payment rate. Commenters again requested that CMS develop 
and propose a new methodology.
    Response: The comments received on the methodology for the proposed 
rule are similar to those received during CY 2023 and CY 2024 
rulemaking. We refer readers to our responses to those comments in the 
CY 2023 HH PPS final rule (87 FR 66797 through 66804) and CY 2024 final 
rule (88 FR 77689). In those rules, we responded to commenters' 
statements that they believe our final methodology was a violation of 
the Social Security Act, as well as commenters' technical concerns, 
such as the inclusion of therapy visits as part of our methodology. In 
this year's proposed rule, we did not propose any changes to the 
behavior adjustment methodology, as we finalized this methodology to 
evaluate the impact of the differences of assumed versus actual 
behavior changes on estimated aggregate expenditures, which is an 
ongoing evaluation for all the years in which a payment adjustment is 
appropriate.
d. CY 2023 Final Claims Results
    We will continue the practice of using the most recent complete 
home health claims data available at the time of rulemaking. The CY 
2023 analysis presented in the CY 2025 HH PPS proposed rule was 
considered preliminary and as additional data became available from the 
latter half of CY 2023, we updated our results in this final rule. 
While the claims data and the permanent and temporary adjustment 
results in this final rule will be considered complete, any adjustments 
to future payment rates may be subject to additional considerations 
such as permanent adjustments taken in previous years.
    The claims data used in rulemaking is released twice each year in 
the HH PPS Limited Data Set (LDS) file, one for the proposed and one 
for the final. Accordingly, the HH PPS LDS file released with this 
final rule includes two files: the actual CY 2023 30-day periods and 
the CY 2023 simulated 60-day episodes.
    We remind readers a data use agreement (DUA) is required to 
purchase the CY 2025 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.\1\ In 
addition, the final CY 2025 Home Health Descriptive Statistics from the 
LDS Files spreadsheet is available on the HH PPS Regulations and 
Notices web page,\2\ 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 
2023 that were used to determine the adjustments. The spreadsheet also 
provides information such as the number of episodes and periods by 
case-mix group, case-mix weights, and simulated payments.
---------------------------------------------------------------------------

    \1\ https://www.cms.gov/research-statistics-data-and-systems/files-for-order/limiteddatasets/home_health_pps_lds.
    \2\ https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HomeHealthPPS/Home-Health-Prospective-Payment-System-Regulations-and-Notices.
---------------------------------------------------------------------------

e. Applying the Methodology to CY 2023 Data To Determine the CY 2025 
Permanent and Temporary Adjustments
    Using the methodology finalized in the CY 2023 HH PPS final rule to 
apply for all the years in which an adjustment is appropriate, and 
described most recently in the CY 2024 HH PPS final rule (88 FR 77687 
through 77688), as well as the two new assumptions related to the 
OASIS-E mapping, we simulated 60-day episodes using actual CY 2023 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.
    Using the final CY 2023 dataset, we began with 8,319,064 30-day 
periods of care and dropped 513,580 30-day periods of care that had a 
claim occurrence code 50 date after October 31, 2023. We also excluded 
866,308 30-day periods of care that had a claim occurrence code 50 date 
before January 1, 2023, to ensure the 30-day period will not be part of 
a simulated 60-day episode that began in CY 2022. Applying the 
additional exclusions and assumptions as described in the finalized 
methodology (87 FR 66804), an

[[Page 88366]]

additional 13,508 30-day periods were excluded.
    Additionally, we excluded 204,597 simulated 60-day episodes of care 
where no OASIS information was available in the Chronic Conditions Data 
Warehouse (CCW) Virtual Research Data Center (VRDC), a recent SOC/ROC 
OASIS was not available, a wage index was not available, or the episode 
could not be grouped to a Health Insurance Prospective Payment System 
(HIPPS) code 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 (69.0 percent) and single 30-day periods of care (31.0 
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 for this final rule 
included 6,541,678 actual 30-day periods of care and 3,870,602 
simulated 60-day episodes of care for CY 2023.
    Using the final dataset for CY 2023 (6,541,678 actual 30-day 
periods which made up the 3,870,602 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 2023 and therefore, we determined the CY 2023 30-day base 
payment rate should have been $1,875.46 based on actual behavior, as 
shown in table 2. As stated in the CY 2024 final rule (88 FR 77693) we 
determined for CYs 2020 through CY 2022 a total of -5.779 percent 
permanent adjustment was needed (after accounting for the -3.925 
percent applied to the CY 2023 payment rate). In order to determine 
behavior changes for only CY 2023, we simulated what the CY 2023 base 
payment rate would have been if the -5.779 percent adjustment that we 
determined using CY 2022 claims data had been implemented.
    Using the recalculated CY 2022 base payment rate of $1,839.10 (88 
FR 77693), multiplied by the CY 2023 case-mix weight recalibration 
neutrality factor (0.9904), the CY 2023 wage index budget neutrality 
factor (1.0001) and the CY 2023 home health payment update factor 
(1.040), the CY 2023 base payment rate for assumed behavior would have 
been $1,894.49. For the CY 2023 annual permanent adjustment, we 
calculated the percent change between the two payment rates for only CY 
2023 (assuming the -5.779 percent adjustment was already taken). For 
the temporary adjustment we calculated the difference in aggregate 
expenditures in dollars for all CY 2023 PDGM 30-day claims using the 
actual payment rate ($2,010.69) and recalculated payment ($1,875.46). 
This difference is shown as the retrospective dollar amount needed to 
offset payment in a future year. Our results for the CY 2023 annual 
(single year) permanent and temporary adjustment calculations using CY 
2023 final claims data are shown in table 2.
[GRAPHIC] [TIFF OMITTED] TR07NO24.008

    As shown in table 2, a permanent prospective adjustment of -1.004 
percent to the CY 2025 30-day payment rate (assuming the-5.779 percent 
adjustment was already taken) for CY 2023 would be required to offset 
for such increases in estimated aggregate expenditures in future years. 
We remind readers, the permanent prospective adjustment of -1.004 
percent is for illustrative purposes only and the annual (single year) 
permanent adjustment cannot be added to previous annual adjustments. To 
illustrate the annual calculation for CY 2023 claims only:
[GRAPHIC] [TIFF OMITTED] TR07NO24.010

    Section 1895(b)(3)(D) of the Act requires us to annually analyze 
data from CY 2020 through CY 2026 and offset any increases or decreases 
in estimated aggregate expenditures at a time and manner determined 
appropriate. We now have four years of claims data (CYs 2020-2023) 
under the PDGM, with one of these years including a partial permanent 
adjustment. Later we provide an illustration of the annual (single 
year)

[[Page 88367]]

permanent adjustments calculated on the discrete year of claims. We 
remind readers these annual adjustments cannot be added or multiplied 
together to determine the total permanent adjustment needed for CY 2025 
because each individual year requires an assumption that all prior 
adjustments were taken. We provided an illustrative equation in the CY 
2025 HH PPS proposed rule (89 FR 55335) using the annual adjustment. We 
remind readers that equation may result in slightly different results 
due to the underlying assumptions each year and rounding.
[GRAPHIC] [TIFF OMITTED] TR07NO24.009

    Additionally, we determined that our initial estimate of the base 
payment rate ($2,010.69) resulted in excess expenditures of 
approximately $971 million in CY 2023. This will require a temporary 
adjustment, where the dollar amount ($971 million) will be converted to 
a factor when implemented, to offset for such increases in estimated 
aggregate expenditures for CY 2023.
f. CY 2025 Final Permanent Adjustment and Temporary Adjustment 
Calculations
    In the preceding section we describe how we annually analyzed CY 
2023 final claims data to determine the effects of actual behavior 
change on estimated aggregate expenditures. Again, that analysis 
included simulations that assumed that the -5.779 percent payment 
adjustment was already taken. We note that CMS implemented a payment 
adjustment of-2.890 percent for CY 2024, rather than the -5.779 percent 
we calculated (88 FR 77697), so the calculations set forth later in 
this section reflect the remaining adjustments that are still needed.
    Therefore, the calculation in this section includes any of the 
remaining adjustments not applied in previous years (that is, CYs 2020 
to 2022 claims data), as well as the adjustment needed to account for 
CY 2023 claims. In calculating the full permanent adjustment needed to 
the CY 2025 30-day payment rate, we compare estimated aggregate 
expenditures under the PDGM and the prior system. Unlike the annual 
adjustments described in table 3, we do not assume the full adjustment 
from prior years had been taken.
    As discussed in section II.C.1.d. of this final rule, using the 
final dataset for CY 2023 (6,541,678 actual 30-day periods which made 
up the 3,870,602 simulated 60-day episodes) we determined the CY 2023 
30-day base payment rate should have been $1,875.46 based on actual 
behavior, rather than the actual CY 2023 30-day base payment rate 
($2,010.69) based on assumed behaviors. The percent change, as shown in 
table 4, between the actual CY 2023 base payment rate of $2,010.69 
(based on assumed behaviors and included a -3.925 percent adjustment 
applied to the CY 2023 payment rate) and the CY 2023 recalculated base 
payment rate of $1,875.46 (based on actual behaviors) is the total 
permanent adjustment need for CYs 2020 through 2023 claims.
[GRAPHIC] [TIFF OMITTED] TR07NO24.012

    As shown in table 4, a permanent prospective adjustment of -6.726 
percent to the CY 2025 30-day payment rate for CYs 2020 through 2023 
will be required to offset for such increases in estimated aggregate 
expenditures in future years. To illustrate this calculation:
[GRAPHIC] [TIFF OMITTED] TR07NO24.011


[[Page 88368]]


    As we stated in the CY 2024 HH PPS final rule (88 FR 77697), 
applying a -2.890 percent permanent adjustment to the CY 2024 30-day 
payment rate will not adjust the rate fully to account for differences 
in behavior changes on estimated aggregate expenditures in CYs 2020, 
2021, and 2022. Using CY 2023 claims data, as shown in table 5, a 
permanent prospective adjustment of -6.726 percent to the CY 2025 30-
day payment rate will be required to offset for such increases in 
estimated aggregate expenditures for CYs 2020 through 2023. We remind 
readers adjustment factors are multiplied in this payment system and 
therefore, individual numbers (that is, percentages) cannot be added or 
subtracted together to determine the final adjustment. Therefore, we 
cannot determine the CY 2025 proposed permanent adjustment, which will 
include estimated aggregate expenditures in CY 2023, by simply 
subtracting the -2.890 percent applied in CY 2024 from the total 
permanent adjustment of -6.726 percent.
    Instead, we account for the permanent adjustment applied in CY 2024 
of -2.890 percent when we calculate the CY 2025 permanent adjustment by 
solving the following equation (1-0.0289) x (1-x) = (1-0.06726). To 
illustrate this calculation we used the following approach.
[GRAPHIC] [TIFF OMITTED] TR07NO24.014

    In table 5 we provide the base payment rate for assumed behaviors 
(what CMS actually paid), the recalculated base payment rate for actual 
behaviors (what CMS should have paid), the total permanent adjustments 
calculated from the base payment rates (accounts for any adjustments 
taken prior), and the permanent adjustment applied.
[GRAPHIC] [TIFF OMITTED] TR07NO24.013

    In the CY 2025 HH PPS proposed rule (89 FR 55337), we proposed to 
apply the full permanent adjustment we (then) calculated of -4.067 
percent, noting that we would update this percentage using more 
complete claims data in the final rule, to satisfy the statutory 
requirements at section 1895(b)(3)(D) of the Act to offset any 
increases or decreases on the impact of differences between assumed 
behavior and actual behavior changes on estimated aggregate 
expenditures, reduce the need for any future large permanent 
adjustments, and help slow the accrual of the temporary payment 
adjustment amount. Using more complete claims data, and as calculated 
previously, the permanent adjustment to the CY 2025 30-day payment rate 
would be a reduction of 3.95 percent.
    We remind readers that while we have not yet proposed a methodology 
on how CMS will apply the temporary adjustment on a prospective basis 
to the base payment rate, we finalized the methodology for determining 
the temporary adjustment dollar amount in the CY 2023 HH PPS final rule 
(87 FR 66804). We stated in the CY 2023 HH PPS final rule (87 FR 
66804), the CY 2024 HH PPS proposed rule (88 FR 43674) and in the CY 
2025 HH PPS proposed rule (89 FR 55337), that after we determine the 
total dollar amount to be reconciled, we will calculate a temporary 
adjustment factor to be applied to the base payment rate for the year 
in which it is implemented. In other words, the total dollar amount for 
the temporary adjustment will not change as data analysis in the final 
rules

[[Page 88369]]

are considered complete. In table 6, we provide the temporary 
adjustment dollar amount for each year and the overall total.
[GRAPHIC] [TIFF OMITTED] TR07NO24.015

    We did not propose to take the temporary adjustment in CY 2025. In 
future rulemaking, we will propose the temporary adjustment dollar 
amount to be converted to a factor to be applied to the national, 
standardized base payment rate in a time and manner determined 
appropriate.
    Comment: Commenters stated that they believe CMS has not provided 
data, or that they believe the data presented is inaccurate to 
demonstrate behavior changes, and therefore, they believe any payment 
adjustment is not supported.
    Response: We disagree that we have not provided commenters with the 
data on which we relied, or that we relied on inaccurate data. We 
provided our extensive data in the CY 2022 HH PPS proposed rule (86 FR 
35880 through 35889), the CY 2023 HH PPS proposed rule (87 FR 37605 
through 37614), the CY 2024 HH PPS proposed rule (88 FR 43663 through 
43671), and the CY 2025 HH PPS proposed rule (89 FR 55318 through 
55327). 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 the materials from the webinar, including the 
presentation and the data files were published on the CMS website.\3\ 
As stated previously, CMS also provides twice a year (that is, proposed 
and final rules) the HH PPS LDS file and the Home Health Descriptive 
Statistics from the LDS Files. Therefore, CMS has provided this data 
numerous times through rulemaking and made all data files used in 
assessing behavior changes and rate setting available for interested 
parties.
---------------------------------------------------------------------------

    \3\ Home Health Patient-Driven Groupings Model web page at 
https://www.cms.gov/medicare/medicare-fee-for-service-payment/homehealthpps/hh-pdgm.
---------------------------------------------------------------------------

    Comment: The majority of commenters opposed the proposed permanent 
adjustment to the CY 2025 home health rate and requested CMS postpone 
its application in order to preserve access to home health services and 
the scope of care available. Commenters stated that they believe CMS 
dismissed data analysis presented from interested parties showing an 
increase in referral rejections, which commenters purport is caused by 
the permanent rate adjustment. These commenters stated that this ``on-
going pattern of loss of access to care'' is directly related to 
implementation of the PDGM and payment adjustments related to the 
behavior adjustment analysis and that CMS has an obligation to answer 
the questions posed through these analyses. The most common themes 
commenters presented as support for their concern that another 
permanent adjustment in CY 2025 is exacerbating an unstable home health 
benefit are negative margins, increasing costs, labor shortages, and 
increasing referral rejections by HHAs.
    Response: We diligently review all comments and analysis from 
interested parties submitted through public comment on proposed rules. 
Our review of data and comments provided by interested parties, as well 
as our own internal data and analysis, helps the agency implement 
appropriate payment policies. This thorough process helps guide agency 
decision making, as we have discretion to implement regulations and 
payment adjustments in a time and manner deemed appropriate. Throughout 
the policy-making process, we monitor the effects the PDGM and Medicare 
home health payment rates have on access to care, including the number 
of beneficiaries accessing the benefit as well as the number of 
providers furnishing services. We carefully analyze our own data 
extracted through the CCW VRDC, claims review, and examination of cost 
reports. CMS also monitors the effects of the PDGM on the quality of 
care provided by HHAs through the home health quality reporting program 
(HH QRP),\4\ and we refer readers to section III of this rule for 
further information about the HH QRP. To the extent commenters suggest

[[Page 88370]]

access to care concerns mean we should not make any behavioral 
adjustments, such concerns cannot override our statutory obligations. 
As for the suggestion that access to care issues justify delaying 
implementation of the permanent behavioral adjustments, our analysis 
has not identified sufficient evidence that delaying the implementation 
of the permanent adjustment will have a significant effect on access to 
care or the issues commenters describe as destabilizing the home health 
benefit. Below, we respond to these concerns and discuss potential 
influencing factors that may affect the home health industry beyond the 
permanent behavioral adjustments.
---------------------------------------------------------------------------

    \4\ https://www.cms.gov/medicare/quality/home-health.
---------------------------------------------------------------------------

    We understand that commenters are concerned that the PDGM might 
have narrowed the gap between the margins providers receive treating 
patients enrolled in Medicare-FFS and the margins providers receive 
from patients with other health coverage. However, as we stated in the 
CY 2023 HH PPS final rule (87 FR 66807) and the CY 2024 HH PPS final 
rule (88 FR 77695), Medicare does not set payments to cross-subsidize 
other payers, as we are mindful of our obligation to be responsible 
stewards of the Medicare Trust Funds. Many commenters stated outright 
that Medicare should consider all-payor margins when evaluating the 
accuracy of the Medicare home health payment rate. While CMS analyzes 
Medicare margins as a financial gauge overall to the soundness of the 
home health industry, we again note that 42 CFR 413.5 states that 
``costs attributable to other patients of the institution are not to be 
borne by the program''--``the program'' being Medicare. In other words, 
when setting payment rates, CMS is not required to consider any 
shortfalls or deficits created by the payment rates of insurance 
programs covering other patients.
    Our analysis of cost reports submitted by HHAs shows that Medicare 
payment rates exceed costs of care by 32 percent (89 FR 55321). 
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 presented in the CY 2024 HH PPS 
final rule (88 FR 77695), along with data reported by MedPAC, an 
independent congressional agency,\5\ 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 Medicare 
margins. We also note that we reviewed an annual outlook survey \6\ of 
152 home health market participants (72 percent of which were 
executives, see page 4) published by Homecare Homebase (HCHB), an 
electronic health records service provider to home health agencies that 
report their software serves ``all ten of the top ten largest home 
health agencies.'' \7\ Approximately 85 percent of survey participants 
reported they expect their organization's overall revenue to stay the 
same (20 percent) or increase (65 percent) in 2024 compared to 2023 
(pg. 7). We understand this survey is only a sample and may not 
represent every HHA; however, it is important to recognize that many 
home health executives report an overall positive market outlook 
despite the permanent adjustment to the home health payment rate 
implemented in CY 2023.
---------------------------------------------------------------------------

    \5\ https://www.medpac.gov/wp-content/uploads/2024/03/Mar24_MedPAC_Report_To_Congress_SEC-2.pdf.
    \6\ https://hchb.com/resources/white-papers/survey-2024-hhcn-outlook-survey-and-report/.
    \7\ https://hchb.com/faqs/.
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    We acknowledge commenters' concerns regarding staff shortages. 
Similar to what we stated in the CY 2024 HH PPS final rule (88 FR 
77696), we recognize there are widespread staffing shortages across the 
spectrum in healthcare as well as the general labor market. But the 
statute limits behavioral adjustments to those attributable to the 
implementation of the PDGM, and commenters do not cite evidence 
suggesting staffing shortages are attributable to those changes. We 
primarily account for those challenges in other ways, such as the 
market basket as explained in section II.C of this final rule. As we 
stated above and previously, delaying the permanent adjustment now will 
only lead to larger permanent adjustments in the future, and any 
temporary savings by HHAs will be offset by larger future temporary 
adjustments.
    We also considered the referral analysis industry advocates again 
submitted using their proprietary data. While we welcome analysis 
conducted by industry advocates and incorporate insights from the 
industry's experience and data as appropriate, for reasons including 
those explained in the CY 2024 HH PPS final rule (88 FR 77695), we must 
use Medicare FFS data to set Medicare FFS policy. We appreciate that 
the industry advocates addressed some of the concerns with their data 
that we raised last year. However, they did not address whether their 
proprietary data contains information from other payors, such as 
Medicare Advantage (MA) plans.
    It is important to note that neither our nor the industry's 
analysis of referral rejections studied causation. In other words, an 
increase of non-acceptance to home health does not necessarily indicate 
that delaying the payment adjustment would increase referral 
acceptance. The industry appears to assume that the main reason an HHA 
would reject a referral is because the HHA cannot afford to provide the 
services for the referred patient based on the Medicare home health 
payment rate. As noted above, CMS's analysis of home health costs 
suggests the payment rate is adequate to provide services to 
beneficiaries, and any number of reasons exist that could result in a 
patient not receiving home health services. For instance, not every 
patient is found to be eligible for home health upon initial assessment 
and some patients decline home health despite being referred. 
Additionally, HHAs decide which services they can provide (in addition 
to skilled nursing) and may not be appropriately staffed to provide the 
services in the patient's plan of care. For example, a patient may need 
skilled nursing, physical therapy, and occupational therapy, but the 
referred HHA is not appropriately staffed with (or contracted with) an 
occupational therapist. Therefore, even large increases in referral 
rejections would not necessarily justify delaying the permanent 
adjustment or substantiate concerns that HHAs cannot afford to accept 
patients based on the national-standardized payment rates.
    Nevertheless, based on the industry's suggestion that their data 
suggests that there has been an increase in referral rejections since 
we implemented the PDGM, we conducted our own referral analysis using 
Medicare FFS data, and our findings, as shown in figure 7, differ from 
the industry's. We acknowledge that there will always be a certain 
percentage of referral rejections, for example, patient refusal or 
ineligibility, and our analysis indicates that the rejection rate has 
been relatively stable with less than a five percent change from CY 
2020 to 2023.
    In conducting our referral analysis, we first determined 
``referrals'' by identifying FFS acute inpatient, inpatient 
rehabilitation facility (IRF), skilled nursing facility (SNF), and 
outpatient claims that had a discharge status code indicating home 
health. While a beneficiary may be counted more than once (for example, 
multiple inpatient admissions in a year), each claim with a discharge 
to home health is considered its own referral. Figure 7 illustrates the 
percentages of claims

[[Page 88371]]

with a discharge status code indicating home health services.
[GRAPHIC] [TIFF OMITTED] TR07NO24.016

    We found from 2018 to 2023 referrals to home health services from 
acute inpatient claims remained stable, increased for IRF claims, 
decreased for SNF claims, and increased for outpatient claims.
    Next, utilizing the same time period (CYs 2018-2023), we excluded 
any home health claims where the beneficiary did not have an acute 
inpatient, IRF, SNF, or outpatient claim preceding the home health 
claim. We specifically looked at acute inpatient, IRF, SNF or 
outpatient claims because this is the clearest way to determine that 
the beneficiary was referred to home health based on the discharge 
status codes. We then analyzed the number of days between the acute 
inpatient, IRF, SNF, and outpatient claim (with a discharge status code 
to home health) through date and the home health claim from date. Per 
42 CFR 484.55(a)(1) the initial assessment visit must be held within 48 
hours of referral, or within 48 hours of the patient's return home, or 
on the physician or allowed practitioner-ordered start of care date. 
Therefore, we limited our analysis to a home health claim start date 
within seven days of the non-home health claim through date. For 
example, an acute inpatient claim has a through-date of January 31st, 
and the same beneficiary has a home health claim start date on or 
before February 7th. Figure 8 illustrates the percentage of acute 
inpatient, IRF, SNF, and outpatient claims that had a discharge status 
code to home health and the beneficiary having a home health claim 
within seven days of discharge from an acute inpatient, IRF, SNF, or 
outpatient setting.

[[Page 88372]]

[GRAPHIC] [TIFF OMITTED] TR07NO24.017

    Our analysis shows on average, beneficiaries with acute inpatient, 
IRF, SNF, and outpatient claims had a home health claim within seven 
days of discharge: 79 percent, 86 percent, 75 percent, and 71 percent, 
respectively from 2018 to 2023. Overall, we found, on average, 80 
percent of referrals from acute inpatient, IRF, and SNF claims have a 
home health claim within seven days of discharge, while outpatient had 
71 percent of referrals on average. In our analysis we found an average 
of 80 percent, 79 percent, and 75 percent acceptance of referrals for 
2018 (pre-PDGM), 2020 (PDGM), and 2023 (PDGM) respectively for Medicare 
FFS beneficiaries.
    Our analysis shows that there is a 4.2 percent reduction in the 
referral acceptance rate between 2020 and 2023 which is less than half 
the approximate 10 percent reduction in the referral acceptance rate 
the industry found in that same time. We note that we do not expect 
that all referrals to home health would result in acceptance of those 
referrals. As mentioned previously, there are several reasons for non-
acceptance of a referrals, including patient ineligibility for home 
health services. The purpose of the referral analysis shown in this 
final rule is to compare the Medicare FFS referral rejection rate to 
the industry's analysis of the referral rejection rate using their 
proprietary data. The industry reported an approximate 77 percent, 75 
percent, and 65 percent acceptance of referrals for 2018 (pre-PDGM), 
2020 (PDGM), and 2023 (PDGM) respectively for their study population. 
One reason for the different results could be the different population 
the industry studied. As described in the CY 2025 HH PPS proposed rule 
(89 FR 55319) there was a total of about 17.1 million unique FFS 
beneficiaries from 2018 to 2023.\8\ Commenters stated that their 
referral analysis was ``based on 25.7 million patients who entered 
Homecare Homebase from 2018 through the present.'' It is unclear why 
the Homecare Homebase data included an additional 8.6 million patients. 
One possibility is that that Homecare Homebase's database included 
patients who were not enrolled in Medicare FFS or used other payors. As 
explained above, we set Medicare FFS policy based on how it affects 
Medicare FFS beneficiaries--not how it affects other payors' enrollees.
---------------------------------------------------------------------------

    \8\ Some beneficiaries may be counted across years, and 
therefore the total may overestimate the total number of 
beneficiaries between 2018 and 2023.
---------------------------------------------------------------------------

    Comment: Commenters also highlighted a decrease in the number of 
HHAs since the implementation of the PDGM and this decrease may be 
contributing to the lack of access to care and increased referral 
rejections.
    Response: In the CY 2024 HH PPS final rule (88 FR 77696) we stated 
awareness of changes in the home health industry. We acknowledged that 
the home health landscape is changing as HHAs continue to be 
consolidated and bought by private equity firms and the increase of 
for-profit agencies. For example, in our data we identified a total of 
8,674 HHAs that had ownership status available, and 82 percent are for-
profit; 15 percent are non-profit, and 3 percent government owned. In 
their 2024 report, MedPAC describes a continuous decline in the number 
of HHAs since 2013, while the supply of agencies remained relatively 
stable after the implementation of PDGM in 2020.\9\ MedPAC also notes 
that relative to the FFS Medicare population alone, the supply of 
agencies increased (to 2.3 HHAs per 10,000 FFS beneficiaries) because 
the 2022 decline in FFS Medicare beneficiaries was greater than the 
decline in the number of agencies. Further, our own analysis shows that

[[Page 88373]]

there is only a 1.7 percent decline in the number of HHAs with at least 
one claim in 2019 to the number of HHAs with at least one claim in 
2023, and the vast majority of Medicare beneficiaries live in counties 
with a few HHAs with positive margins. While the distribution of HHAs 
have changed, there is no evidence to support that this is solely 
attributable to adjustments to the home health payment rates and, 
again, note that the change in ownership practices could be 
contributing to the slight decline in the number of HHAs.
---------------------------------------------------------------------------

    \9\ Medicare Payment Advisory Commission, Report to the 
Congress: Medicare Payment Policy, Washington, D.C. (March 2024)--
https://www.medpac.gov/wp-content/uploads/2024/03/Mar24_Ch7_MedPAC_Report_To_Congress_SEC.pdf.
---------------------------------------------------------------------------

    Comment: We have continued to receive concerns from commenters 
regarding ``inappropriate practice patterns,'' suggesting again that 
HHAs may change how they operate in accordance with payment. In 
response to the CY 2025 HH PPS proposed rule, CMS received many letters 
from therapists and other home health care practitioners detailing 
administrative mandates from HHAs limiting how many visits a patient 
may receive. Further, many of these commenters stated that it was not 
their salary that would cause them to leave the home health 
environment, but the strict direction detailing the limits of their 
practice in order to generate profit for the agency.
    Response: These comments mirror comments we responded to in last 
year's HH PPS final rule discussing the potential for the functional 
impairment levels to create an incentive for HHAs to hand-pick patients 
based on their predicted case mix grouping. We again emphasize that the 
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 influence a practitioner on what should be included in the plan 
of care based on the HHA's own financial constraints and staffing 
abilities. As stated in the CY 2024 HH PPS final rule (88 FR 77699), we 
expect the provision of services be made to best meet the patient's 
care needs and in accordance with the home health CoPs at Sec.  484.60, 
and that it is not proper for HHAs to under-supply care or services or 
reduce the number of visits in response to payment, as this would be a 
violation of the CoPs.
    A commenter summed up many of these comments by stating that ``rate 
cuts lead to care cuts.'' We acknowledge commenters' concerns that they 
believe HHAs are dictating practice patterns in response to the 
implementation of the PDGM. However, Medicare sets payment rates in 
accordance with statutory requirements, and not HHA's business 
practices. Moreover, access to care is impacted by many factors. This 
may include factors as varied as labor conditions, patient mix, 
industry margins, and competitive pressures. Congress changed the home 
health prospective payment system in the BBA of 2018 and instructed CMS 
to further adjust payment rates to account for differences between the 
behavior changes we predicted in the CY 2019 rule and the actual 
behavior changes we have observed since the implementation of the PDGM 
in CY 2020. We are implementing these payment adjustments in a time and 
manner appropriate in accordance with the law, while mindful of 
possible disruptions this implementation may cause to the services to 
which beneficiaries are entitled. Our analysis continues to suggest 
that the permanent adjustment we are finalizing here to the CY 2025 
base payment rate should not materially affect access to the Medicare 
home health benefit.
    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 are committed to remaining responsive to commenter concern 
regarding on-going permanent rate adjustments. We acknowledge that 
while we must 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, we have the discretion to implement any adjustment in a 
time and manner determined appropriate. Therefore, in response to 
commenter concerns, we are finalizing a -1.975 percent (half of the 
proposed -3.95 percent) permanent adjustment for CY 2025. This approach 
of applying half of the amount proposed for the permanent adjustment is 
aligned with the approach finalized in the CY 2023 HH PPS final rule 
(87 FR 66808) and the CY 2024 HH PPS final rule (88 FR 77697) where CMS 
finalized half of the remaining permanent adjustment, as indicated by 
the most recently available claims data. However, again, we note the 
permanent adjustment to account for actual behavior changes in CYs 2020 
through 2023, should be -3.95 percent, which includes the remaining 
``half'' from the CY 2024 HH PPS final rule, and the additional 
adjustment based on CY 2023 data. Therefore, applying a -1.975 percent 
permanent adjustment to the CY 2025 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 
2025 base payment rate using our temporary adjustment authority, as 
section 1895(b)(3)(D)(iii) of the Act 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 (-3.95 
percent) in effect, the total temporary dollar amount will continue to 
increase until the full permanent adjustment is implemented.

D. CY 2025 Home Health Low Utilization Payment Adjustment (LUPA) 
Thresholds, Functional Impairment Levels, Comorbidity Sub-Groups, Case-
Mix Weights, and Reassignment of Specific ICD-10-CM Codes Under the 
PDGM

1. CY 2025 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 setting the LUPA thresholds at the 10th percentile of visits 
or two visits, whichever is higher, for each payment group. This means 
the LUPA threshold for each 30-day period of care varies depending on 
the PDGM payment group to which it is assigned. If the LUPA threshold 
for the payment group is met under the PDGM, the 30-day period of care 
will be paid the full 30-day period case-mix adjusted payment amount 
(subject to any partial payment adjustment or outlier adjustments). If 
a 30-day period of care does not meet the PDGM LUPA visit threshold, 
then payment will be made using the per-visit payment amounts as 
described in section II.E.4.c. 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 fewer visits, payment is made using the 
per-visit payment amounts.
    In the CY 2019 HH PPS final rule with comment period (83 FR 56492), 
we finalized our policy that the LUPA thresholds for each PDGM payment 
group will be reevaluated every year based on the most current 
utilization

[[Page 88374]]

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 will maintain 
the LUPA thresholds that were finalized and shown in table 17 of the CY 
2020 HH PPS final rule with comment period (84 FR 60522) for CY 2021 
payment purposes. We stated that at that time, we did not have 
sufficient CY 2020 data to reevaluate the LUPA thresholds for CY 2021.
    In the CY 2022 HH PPS final rule with comment period (86 FR 62249), 
we finalized the proposal to recalibrate the PDGM case-mix weights, 
functional impairment levels, and comorbidity subgroups while 
maintaining the LUPA thresholds for CY 2022. We stated that because 
there are several factors that contribute to how the case-mix weight is 
set for a particular case-mix group (such as the number of visits, 
length of visits, types of disciplines providing visits, and non-
routine supplies) and the case-mix weight is derived by comparing the 
average resource use for the case-mix group relative to the average 
resource use across all groups, we believe the COVID-19 PHE will have 
impacted utilization within all case-mix groups similarly. Therefore, 
the impact of any reduction in resource use caused by the PHE on the 
calculation of the case-mix weight will be minimized since the impact 
will 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 will 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 2024, we proposed to update the LUPA thresholds using CY 
2022 Medicare home health claims (as of March 17, 2023) linked to OASIS 
assessment data. We believed that CY 2022 data will be more indicative 
of visit patterns in CY 2024 rather than continuing to use the LUPA 
thresholds derived from the CY 2018 data pre-PDGM. Therefore, we 
finalized a policy to update the LUPA thresholds for CY 2024 using data 
from CY 2022.
    For CY 2025, we proposed to update the LUPA thresholds using CY 
2023 home health claims utilization data (using more complete CY 2023 
claims data as of July 11, 2024), in accordance with our policy to 
annually recalibrate the case-mix weights and update the LUPA 
thresholds, functional impairment levels and comorbidity subgroups. 
After reviewing the CY 2023 home health claims utilization data, we 
determined that LUPA visit patterns in 2023 were similar to visits in 
2021 and a total of eight case-mix groups have a decline in their LUPA 
threshold of a single visit. The proposed LUPA thresholds for the CY 
2025 PDGM payment groups with the corresponding Health Insurance 
Prospective Payment System (HIPPS) codes and the case-mix weights can 
be found in the CY 2025 HH PPS proposed rule (89 FR 55349). We 
solicited public comment on the proposed updates to the LUPA thresholds 
for CY 2025.
    Comment: All commenters expressed support for the updated LUPA 
thresholds and recognized that this adjustment helps align payments 
more closely with evolving care delivery and improves payment accuracy.
    Response: We thank the commenters for their support.
    Final Decision: We are finalizing the proposal to update the LUPA 
thresholds for CY 2025 using CY 2023 claims data (as of July 11, 2024). 
The final LUPA thresholds for the CY 2025 PDGM payment groups with the 
corresponding Health Insurance Prospective Payment System (HIPPS) codes 
and the case-mix weights are listed in table 7 and is also available on 
the HHA Center web page, located at https://www.cms.gov/medicare/enrollment-renewal/providers-suppliers/home-health-agency-center.
2. CY 2025 Functional Impairment Levels
    Under the PDGM, the functional impairment level is determined by 
responses to certain OASIS items associated with activities of daily 
living and risk of hospitalization; that is, responses to OASIS items 
M1800-M1860 and M1033. A home health period of care receives points 
based on each of the responses associated with these functional OASIS 
items, which are then converted into a table of points corresponding to 
increased resource use. The sum of all these points results in a 
functional impairment score which is used to group home health periods 
into a functional level with similar resource use. That is, the higher 
the points, the more the response is associated with increased resource 
use, or increased impairment. The three functional impairment levels of 
low, medium, and high were designed so that approximately one-third of 
home health periods from each clinical group falls 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 2025, we proposed to use CY 2023 claims data to update the 
functional points and functional impairment levels by clinical group. 
The CY 2018 HH PPS proposed rule (82 FR 35320) and the technical report 
from December 2016, posted on the Home Health PPS Archive web page, 
located at https://www.cms.gov/medicare/home-health-pps/home-health-pps-archive, provides a more detailed explanation as to the 
construction of the functional impairment levels using the OASIS items. 
We proposed to use the same methodology previously finalized to update 
the functional impairment levels for CY 2025. The final updated OASIS 
functional points table and the table of functional impairment levels 
by clinical group for CY 2025 are listed in tables 7 and 8, 
respectively.
BILLING CODE 4120-01-P

[[Page 88375]]

[GRAPHIC] [TIFF OMITTED] TR07NO24.018


[[Page 88376]]


[GRAPHIC] [TIFF OMITTED] TR07NO24.019

BILLING CODE 4120-01-C
    We solicited public comment on the updates to functional points and 
the functional impairment levels by clinical group.
    Comment: Several commenters opposed the proposed updates to the CY 
2025 functional impairment points and levels. These commenters contend 
that the assignment of functional impairment levels appears arbitrary 
and requested that CMS refrain from making additional changes to the 
functional scoring system that would affect level assignments until the 
impact of CY 2024 updates is fully understood. Several commenters 
expressed concerns that the proposed functional impairment levels may 
not accurately reflect the actual functional status of home health 
patients, particularly those with

[[Page 88377]]

complex or higher-acuity conditions. Specifically, they stated that 
patients with significant needs for assistance with activities of daily 
living may not be adequately represented within the proposed levels, 
potentially leading to a misalignment between the resources required to 
provide care and the associated payment structure. Additionally, 
commenters noted that the agency's proposed recalibration for CY 2025 
does not sufficiently account for what the commenters say is a fact 
that patients entering home health care post-COVID-19 pandemic are, on 
average, more impaired than they were prior to the pandemic. Commenters 
stated that they believe this marks the fourth consecutive year in 
which changes to functional item scoring have been finalized without 
fully considering the impacts of the changes implemented in the 
previous year (that is, CY 2024 changes for CY 2025 rulemaking). 
Commenters requested that CMS delay finalizing any updates to the 
functional domain methodology until CY 2026, when post-pandemic data 
from 2024 can be fully analyzed to assess the appropriateness of 
further modifications.
    Response: We appreciate the commenters' recommendations. However, 
we maintain that annual recalibration is essential to ensure the most 
accurate and current assessment of the relationship between resource 
use and functional points, functional threshold levels, comorbidities, 
utilization thresholds, and case-mix weights. As such, we do not agree 
with delaying updates to the functional impairment points and levels 
for CY 2025. We continue to believe that using the most up-to-date data 
to revise functional impairment levels is critical to ensuring that all 
variables used in the case-mix adjustment process align with the actual 
costs of delivering home health services. We would also like to remind 
commenters that the functional impairment levels are structured so that 
approximately one-third of periods within each clinical group are 
assigned to low, medium, and high categories, ensuring that the case-
mix system appropriately reflects differences in functional impairment. 
This classification of functional impairment into low, medium, and high 
levels has been a fundamental component of the HH PPS since its 
implementation. 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. As such, the PDGM functional impairment structure 
accounts for patient characteristics within each clinical group that 
are associated with increased resource use due to functional 
impairment. This ensures that payment is more accurately aligned with 
patient characteristics, including beneficiaries who have greater need 
with activities of daily living (ADLs) and who are more functionally 
impaired. Regardless of whether patients entering home health are more 
impaired due to the post-COVID environment or any other influence, the 
functional levels capture the relationship between functional status as 
indicated on the OASIS with resource use captured on claims. As such, 
updating the functional levels would specifically capture any increase 
in functional impairment and any increase in resource use associated 
with ADLs.
    Final Decision: We are finalizing the functional points and 
functional impairment level updates for CY 2025 as proposed, using 
updated CY 2023 claims data (as of July 11, 2024).
3. CY 2025 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:
     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.
     Low comorbidity adjustment: There is a reported secondary 
diagnosis on the home health-specific comorbidity subgroup list that is 
associated with higher resource use.
     No comorbidity adjustment: A 30-day period of care 
receives no comorbidity adjustment if no secondary diagnoses exist or 
do not meet the criteria for a low or high comorbidity adjustment.
    In the CY 2019 HH PPS final rule with comment period (83 FR 56406), 
we stated that we will 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 2025, we proposed to use the same 
methodology used to establish the comorbidity subgroups to update the 
comorbidity subgroups using CY 2023 home health data with linked OASIS 
data.
    For CY 2025, we proposed to update the comorbidity subgroups to 
include 22 low comorbidity adjustment subgroups and 97 high comorbidity 
adjustment interaction subgroups. The proposed CY 2025 low comorbidity 
adjustment subgroups and the high comorbidity adjustment interaction 
subgroups including those diagnoses within each of these comorbidity 
adjustments was included in the CY 2025 HH PPS proposed rule (89 FR 
55340).
    We invited comments on the proposed updates to the low comorbidity 
adjustment subgroups and the high comorbidity adjustment interactions 
for CY 2025.
    Using more updated claims data, for CY 2025 there are 22 low 
comorbidity subgroups, and 94 high comorbidity subgroups as shown in 
tables 9 and 10.
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    Comment: Several commenters expressed support for the proposed low 
and high comorbidity adjustments, particularly those pertaining to low 
comorbidity adjustments for diagnoses such as diabetes and endocrine 
disorders. Commenters stated these adjustments will result in more 
accurate payment, reflecting the resources required to effectively 
manage patients with these conditions. Additionally, commenters 
indicated that the proposed changes to the comorbidity subgroups align 
with the stated objective of ensuring that payments more accurately 
reflect the actual costs of providing care.
    Response: We thank commenters for their support.
    Comment: A commenter expressed concern that the COVID-19 diagnosis 
was excluded from the comorbidity grouping list, despite its continued 
impact on elderly and high-risk patients. Another commenter also 
pointed out that Circulatory 1 (nutritional anemias) are grouped with 
Skin 3 (non-pressure ulcers), but not with Skin 4 (pressure ulcers). 
Furthermore, Circulatory 2 (hemolytic, aplastic, and other anemias) are 
no longer grouped with either Skin 3 or Skin 4. Commenters raised 
concerns as to why certain anemias are recognized as having an impact 
on some ulcer types but not others. They also stated that the same 
principle should apply to Circulatory 1 and Circulatory 2, as anemias 
included in Circulatory 2 are likely to result in greater 
complications, such as compromised strength and skin integrity, than 
those in Circulatory 1.
    Response: We appreciate commenters' thorough review of these 
groupings. As outlined in the CY 2020 final rule with comment period 
(84 FR 60510) and further detailed in the technical report ``Overview 
of the Home Health Groupings Model'', the Home Health Specific 
Comorbidity List stems from the principles of patient assessment by 
providers, as well as the evaluation of body systems and their 
associated diseases, conditions, and injuries. This framework was used 
to develop condition categories that identify clinically relevant 
relationships tied to increased resource use.
    We acknowledge the complexity and breadth of clinical conditions, 
comorbidities, and their interactions within the Medicare home health 
population. However, we remind commenters that only subgroups of 
diagnoses representing more than 0.1% of periods of care, and 
demonstrating at least the median resource use, qualify for a low 
comorbidity adjustment. For example, in reference to the commenter's 
concern regarding the grouping of Circulatory 1 (nutritional anemias) 
with Skin 3 (non-pressure ulcers), and the exclusion of Circulatory 2 
(hemolytic, aplastic, and other anemias) from both Skin 3 and Skin 4 
groupings, these categorizations are driven by data reflecting resource 
utilization patterns. If the anemias in Circulatory 2 do not 
demonstrate the requisite median resource use in relation to specific 
ulcer types, such as Skin 4 (pressure ulcers), they would not qualify 
for inclusion in the comorbidity list. This explains why certain 
anemias appear in the comorbidity list for one ulcer category but not 
for another despite clinical similarities or the potential for greater 
clinical complications like compromised strength and skin integrity. 
This methodology for determining statistical significance was detailed 
in the CY 2020 final rule with comment period (84 FR 60510). It is 
based on the understanding that the aggregate number of comorbidities 
within the population forms the standard for payment purposes. While we 
expect HHAs to report all secondary diagnoses that impact care 
planning, nevertheless it is important to note that certain comorbidity 
subgroups included in the Home Health Specific List may not meet the 
criteria for a payment adjustment.
    Final Decision: We are finalizing the updated comorbidity 
adjustment subgroups and the high comorbidity adjustment interactions 
using CY 2023 home health data. For CY 2025, the final updated 
comorbidity adjustment subgroups include 22 low comorbidity adjustment 
subgroups as identified in table 9 and 94 high comorbidity adjustment 
interaction subgroups as identified in table 10. The final CY 2025 low 
comorbidity adjustment subgroups and the high comorbidity adjustment 
interaction subgroups including those diagnoses within each of these 
comorbidity adjustments will also be posted on the HHA Center web page 
at https://www.cms.gov/Center/Provider-Type/Home-Health-Agency-HHA-Center.
4. CY 2025 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 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. 
To generate the proposed recalibrated CY 2025 case-mix weights, we used 
CY 2023 home health claims data with linked OASIS data (as of March 19, 
2024). We included the proposed case-mix weights in table 25 of the 
proposed rule (89 FR 55351). In this final rule, we updated these case-
mix weights with claims data as of July 11, 2024, as shown in table 11. 
These data are the most current and complete data available at the time 
of rulemaking.
    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 25 of the proposed rule 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 2022 home health cost reports. We use 2022 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 
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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 11 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 updated case-mix weights for CY 2025 are listed in table 
12 and will also be posted on the HHA Center web page \10\ upon display 
of this final rule.
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    Changes to the PDGM case-mix weights are implemented in a budget 
neutral manner by multiplying the CY 2025 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 
2025, we will continue the practice of using the most recent complete 
home health claims data at the time of rulemaking, which is CY 2023 
data. The case-mix budget neutrality factor is calculated as the ratio 
of 30-day base payment rates such that total payments when the CY 2025 
PDGM case-mix weights (developed using CY 2023 home health claims data) 
are applied to CY 2023 utilization (claims) data are equal to total 
payments when CY 2024 PDGM case-mix weights (developed using CY 2022 
home health claims data) are applied to CY 2023 utilization data. This 
produces a case-mix budget neutrality factor for CY 2025 of 1.0039.
    We invited public comments on the CY 2025 proposed case-mix weights 
and proposed case-mix weight budget neutrality factor.
    Comment: Several commenters expressed support for the updated case-
mix weights using the most current data available for recalibration.
    Response: We thank the commenters for their support.
    Comment: A few commenters stated that any recalibration should not 
be budget neutral. They stated this stance is based on several factors, 
including the increasing acuity of patients, rising operational 
expenses, growing demand for home health services, and the ongoing 
labor shortage. Commenters stated that these factors warrant 
consideration in ensuring adequate payment to align with the current 
healthcare environment. Specifically, a commenter disagreed with the 
downgrading of points for toilet transfers and ambulation. While the 
commenter acknowledged that budget neutrality drives the reallocation 
of points when others are increased, they expressed concern that 
reducing points for ambulation may place less emphasis on this critical 
task, potentially leading to higher fall rates and, consequently, 
increased hospitalizations. The commenter also noted that while bathing 
points were significantly increased, which they stated was beneficial, 
the commenter stated the increase should not be as substantial, 
especially given the larger reduction in points for toilet transfers 
and ambulation. Additionally, some commenters expressed concern that 
the proposed changes to the case-mix weights contribute to substantial 
year-to-year payment variances, which may have a significant financial 
impact on many providers as case-mix weights are driven lower. These 
commenters noted that this variability in payment could create 
financial challenges for providers, particularly those already dealing 
with increasing costs and labor shortages.
    Response: While we recognize that commenters have consistently 
raised concerns regarding the annual recalibration of case mix weights 
since the policy's initial finalization, we continue to believe that 
annual recalibration of PDGM case mix weights is essential. This 
approach promotes accurate weighting of the case mix weights to reflect 
current home health resource utilization, changes in utilization 
patterns, and the characteristics of patients currently receiving home 
health services. Prolonging recalibration beyond an annual schedule 
could result in greater variation in case mix weights, compared to 
recalibrating using the most recent utilization data. Therefore, we 
believe that utilizing calendar year 2023 data to recalibrate the 
calendar year 2025 case-mix weights is appropriate. We direct 
commenters to review the calendar year 2019 HH PPS final rule with 
comment (83 FR 56502) for the finalized case-mix adjustment 
methodology, as well as the detailed steps taken to determine the case-
mix weight for each of the 432 different PDGM payment groups, which are 
outlined in this final rule. Furthermore, 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 as statutorily 
required in section 1895(b)(3)(A)(i) of the Act, ensuring that changes 
to case-mix weights, functional impairment levels, comorbidity 
adjustments, and updated wage data do not impact overall payments in 
the aggregate.
    We appreciate the commenters' recognition of our efforts to 
recalibrate case-mix weights using the most current data available. 
Regarding concerns about the downgrading of points for toilet transfers 
and ambulation, we recognize the importance of accurately reflecting 
the resource needs associated with these tasks. However, the 
reallocation of points is driven by the need to maintain budget 
neutrality, and any adjustments are made based on current utilization 
data and resource allocation. While a few commenters expressed support 
for the idea of non-budget neutral recalibration, it is important to 
note that, as statutorily required by section 1895(b)(3)(A)(i) of the 
Act, any adjustments to case-mix weights must be made in a budget 
neutral manner to ensure that the aggregate level of payments resulting 
from changes in case-mix weights remains consistent.
    We also acknowledge the concern that case-mix weight changes may 
lead to year-to-year payment variances and potential financial 
challenges for providers. The intent of recalibration is to align 
payments with actual resource use while maintaining overall budget 
neutrality. As always, we will continue to evaluate the impact of these 
adjustments and consider the evolving needs of the home health 
population.
    Final Decision: We are finalizing the recalibrated case-mix weights 
for CY 2025, updated with claims data as of July 11, 2024. 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 2025 national, 
standardized 30-day period payment rate. As stated previously, the 
final case-mix budget neutrality factor for CY 2025 will be 1.0039.
5. Reassignment of Specific ICD-10-CM Codes Under the PDGM
a. Background
    The 2009 final rule ``HIPAA Administrative Simplification: 
Modifications to Medical Data Code Set Standards To Adopt ICD-10-CM and 
ICD-10-PCS'' (74 FR 3328, January 16, 2009), set October 1, 2013, as 
the compliance date for all covered entities under the Health Insurance 
Portability and Accountability Act of 1996 (HIPAA) to use the 
International Classification of Diseases, 10th Revision, Clinical 
Modification (ICD-10-CM) and the International Classification of 
Diseases, 10th Revision, Procedure Coding System (ICD-10-PCS) medical 
data code sets. The ICD-10-CM diagnosis codes are granular and specific 
and provide HHAs a better opportunity to report codes that best reflect 
the patient's conditions that support the need for home health 
services. However, as stated in the CY 2019 HH PPS final rule with 
comment period (83 FR 56473), because the ICD-10-CM is comprehensive, 
it also contains many codes that may not support the need for home 
health services. For example, diagnosis codes that indicate death as 
the outcome are Medicare covered codes but are not relevant to home 
health. In addition, diagnosis and procedure coding guidelines may 
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sequence of ICD-10-CM coding conventions. For example, the underlying 
condition must be listed first (for example, Parkinson's disease must 
be listed prior to Dementia if both codes were listed on a claim). 
Therefore, not all the ICD-10-CM diagnosis codes are appropriate as 
principal diagnosis codes for grouping home health periods into 
clinical groups or to be placed into a comorbidity subgroup when listed 
as a secondary diagnosis. As such, each ICD-10-CM diagnosis code is 
assigned, including those diagnosis codes designated as ``not 
assigned'' (NA), to a clinical group and comorbidity subgroup within 
the HH PPS grouper software (HHGS). We reminded readers the ICD-10-CM 
diagnosis code list is updated each fiscal year with an effective date 
of October 1st and therefore, the HH PPS is generally subject to a 
minimum of two HHGS releases, one in October and one in January of each 
year, to ensure that claims are submitted with the most current code 
set available. Likewise, there may be new ICD-10-CM diagnosis codes 
created (for example, codes for emergency use) or a new or revised edit 
in the Medicare Code Editor (MCE) so an update to the HHGS may occur on 
the first of each quarter (January, April, July, October). We encourage 
readers to check the HHGS routinely at these times, as we do not 
anticipate posting changes to the home health web page.
b. Methodology for ICD-10-CM Diagnosis Code Assignments
    Although it is not our intent to review all ICD-10-CM diagnosis 
codes each year, we recognize that occasionally some ICD-10-CM 
diagnosis codes may require changes to their assigned clinical group 
and/or comorbidity subgroup. For example, there may be an update to the 
MCE unacceptable principal diagnosis list, or we receive public 
comments from interested parties requesting specific changes. Any 
addition or removal of a specific diagnosis code to the ICD-10-CM code 
set (for example, three new diagnosis codes, Z28.310, Z28.311 and 
Z28.39, for reporting COVID-19 vaccination status were effective April 
1, 2022) or minor tweaks to a descriptor of an existing ICD-10-CM 
diagnosis code generally could be implemented as appropriate and may 
not be discussed in rulemaking.
    We rely on the expert opinion of our clinical reviewers (for 
example, nurse consultants and medical officers) and current ICD-10-CM 
coding guidelines to determine if the ICD-10-CM diagnosis codes under 
review for reassignment are significantly similar or different to the 
existing clinical group and/or comorbidity subgroup assignment. As we 
stated in the CY 2018 HH PPS proposed rule (82 FR 35313), the intent of 
the clinical groups is to reflect the reported principal diagnosis, 
clinical relevance, and coding guidelines and conventions. Therefore, 
for the purposes of assignment of ICD-10-CM diagnosis codes into the 
PDGM clinical groups we will not conduct additional statistical 
analysis as such decisions are clinically based and the clinical groups 
are part of the overall case-mix weights.
    As we noted in the CY 2019 HH PPS final rule with comment period 
(83 FR 56486), the home health-specific comorbidity list is based on 
the principles of patient assessment by body systems and their 
associated diseases, conditions, and injuries to develop larger 
categories of conditions that identified clinically relevant 
relationships associated with increased 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. If 
specific ICD-10-CM diagnosis codes are to be reassigned to a different 
comorbidity subgroup (including NA), we will first evaluate the 
clinical characteristics (as discussed previously for clinical groups) 
and if the ICD-10-CM diagnosis code does not meet the clinical 
criteria, then no reassignment will occur. However, if an ICD-10-CM 
diagnosis code does meet the clinical criteria for a comorbidity 
subgroup reassignment, then we will evaluate the resource consumption 
associated with the ICD-10-CM diagnosis codes, the current assigned 
comorbidity subgroup, and the proposed (reassigned) comorbidity 
subgroup. This analysis is to ensure that any reassignment of an ICD-
10-CM diagnosis code (if reported as secondary) in any given year will 
not significantly alter the overall resource use of a specific 
comorbidity subgroup. For resource consumption, we use non-LUPA 30-day 
periods to evaluate the total number of 30-day periods for the 
comorbidity subgroup(s) and the ICD-10-CM diagnosis code, the average 
number of visits per 30-day periods for the comorbidity subgroup(s) and 
the ICD-10-CM diagnosis code, and the average resource use for the 
comorbidity subgroup(s) and the ICD-10-CM diagnosis code. The average 
resource use measures the costs associated with visits performed during 
a home health period and was previously described in the CY 2019 HH PPS 
final rule with comment period (83 FR 56450).
c. Request for ICD-10-CM Diagnosis Code Reassignments to a PDGM 
Clinical Group or Comorbidity Subgroup--Renal 3 Comorbidity Subgroup
    We received questions from interested parties regarding the ICD-10-
CM diagnosis codes N30.00- (acute cystitis) and the ICD-10-CM diagnosis 
code N39.0 (urinary tract infection, site not specified). Specifically, 
CMS received a request to reassign N30.00 to the same clinical and 
comorbidity group as N39.0. The ICD-10-CM diagnosis codes N30.00- 
(acute cystitis) are currently assigned to clinical group J (MMTA--
Gastrointestinal tract and Genitourinary system) when listed as a 
primary diagnosis and not assigned to a comorbidity subgroup when 
listed as a secondary diagnosis. The ICD-10-CM diagnosis code N39.0 
(urinary tract infection, site not specified) is currently assigned to 
clinical group J (MMTA--Gastrointestinal tract and Genitourinary 
system) when listed as a primary diagnosis and assigned to the renal 3 
comorbidity subgroup when listed as a secondary diagnosis.
    We reviewed the ICD-10-CM diagnosis codes related to cystitis 
(N30.-) and determined all 14 of the codes are not assigned to a 
comorbidity subgroup when listed as a secondary diagnosis. Our clinical 
reviewers advised that cystitis, including N30.00- (acute cystitis), is 
to report inflammation of the urinary bladder; whereas N39.0 (urinary 
tract infection, site not specified) is to report the presence of the 
infectious microorganisms in the urinary tract system. In addition, we 
evaluated resource consumption related to the comorbidity subgroup 
renal 3, as well as diagnosis codes N30.00- (acute cystitis) and N39.0 
(urinary tract infection, site not specified) and found that acute 
cystitis on average has a lower resource use than urinary tract 
infection (UTI). As described earlier, based on clinical review and 
resources use analysis, the ICD-10-CM diagnosis codes N30.00- (acute 
cystitis) are currently assigned to the most appropriate comorbidity 
group, not assigned. Therefore, we did not propose a reassignment of 
N30.00- (acute cystitis) at this time.
    Comment: We received a comment requesting we reassign N30.00- 
(acute cystitis) to receive the same clinical grouping and comorbidity 
subgroup as an unspecified UTI. Another commenter stated they believe 
diagnoses were missing from comorbidity groups, such as sepsis that was 
not grouped with UTI. Other commenters requested rheumatic mitral value 
diseases I05.- and aortic rheumatic valve diseases I06.- should be 
assigned to the comorbidity subgroup

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Heart 9 and that F01., Vascular dementia, be reassigned to the 
behavioral health clinical group.
    Response: We appreciate the commenters diligent review of the ICD-
10-CM diagnosis codes and their assigned clinical and comorbidity 
group. We remind readers that not all diagnosis codes are assigned a 
clinical group and/or a comorbidity group under the HH PPS payment 
policy. As we did not propose any reassignments at this time, these 
comments are considered out of scope for this rule. Additionally, to 
evaluate clinically and, when needed, statistically, a request for a 
diagnosis code's clinical group or comorbidity subgroup reassignment, 
we require the current assignment of the diagnosis code(s), the 
requested reassignment, and any supporting evidence for the 
reassignment (for example, similar clinical management and services). 
As we stated in the CY 2023 HH PPS final rule (87 FR 66808) if an ICD-
10-CM diagnosis code is to be reassigned from one clinical group and/or 
a comorbidity subgroup to another clinical/comorbidity group, either 
through a request from the public or internal analysis, as the change 
may affect payment, it is necessary to propose these changes through 
notice and comment rulemaking. Lastly, while we attempt to evaluate 
requests in the order in which they are received, the length of time 
needed to sufficiently evaluate a request varies. For future requests 
for ICD-10 code reassignments, readers can send their request(s) to the 
Home Health Policy mailbox: [email protected].

E. CY 2025 Home Health Payment Rate Updates

1. Final CY 2025 Home Health Market Basket Update for HHAs
    Section 1895(b)(3)(B) of the Act requires that the standard 
prospective payment amounts for home health 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. In the CY 2024 
HH PPS final rule (88 FR 77726), we finalized a rebasing of the home 
health market basket to reflect 2021 cost report data. We also 
finalized a policy for CY 2024 and subsequent years that the labor-
related share will be 74.9 percent, and the non-labor-related share 
will be 25.1 percent. A detailed description of how we rebased the home 
health market basket and labor-related share is available in the CY 
2024 HH PPS final rule (88 FR 77726 through 77742).
    In the CY 2015 HH PPS final rule (79 FR 38384), we finalized our 
methodology for calculating and applying the multifactor productivity 
adjustment. As we explained in that rule, section 1895(b)(3)(B)(vi) of 
the Act, requires that, in CY 2015 (and in subsequent calendar years, 
except CY 2018 (under section 411(c) of the Medicare Access and CHIP 
Reauthorization Act of 2015 (MACRA) (Pub. L. 114-10, enacted April 16, 
2015)), the market basket percentage under the HH PPS as described in 
section 1895(b)(3)(B) of the Act be annually adjusted by changes in 
economy-wide productivity. Section 1886(b)(3)(B)(xi)(II) of the Act 
defines the productivity adjustment to be equal to the 10-year moving 
average of change in annual economy-wide private nonfarm business 
multifactor productivity (as projected by the Secretary for the 10-year 
period ending with the applicable fiscal year, calendar year, cost 
reporting period, or other annual period). The Bureau of Labor 
Statistics (BLS) publishes the official measures of productivity for 
the United States economy. We note that previously the productivity 
measure referenced in section 1886(b)(3)(B)(xi)(II) of the Act was 
published by BLS as private nonfarm business multifactor productivity. 
Beginning with the November 18, 2021, release of productivity data, BLS 
replaced the term ``multifactor productivity'' with ``total factor 
productivity'' (TFP). BLS noted that this is a change in terminology 
only and will not affect the data or methodology. As a result of the 
BLS name change, the productivity measure referenced in section 
1886(b)(3)(B)(xi)(II) of the Act is now published by BLS as ``private 
nonfarm business total factor productivity''. We refer readers to 
https://www.bls.gov for the BLS historical published TFP data. A 
complete description of IHS Global Inc.'s (IGI) TFP projection 
methodology is available on the CMS website at https://www.cms.gov/data-research/statistics-trends-and-reports/medicare-program-rates-statistics/market-basket-research-and-information.
    The proposed home health update percentage for CY 2025 was based on 
the estimated home health market basket percentage increase, specified 
at section 1895(b)(3)(B)(iii) of the Act, of 3.0 percent (based on IHS 
Global Inc.'s first quarter 2024 forecast with historical data through 
fourth quarter 2023). The estimated CY 2025 home health market basket 
percentage increase of 3.0 percent was then reduced by a productivity 
adjustment, in accordance with section 1895(b)(3)(B)(vi) of the Act. 
Based on IGI's first quarter 2024 forecast, the proposed productivity 
adjustment was estimated to be 0.5 percentage point for CY 2025. 
Therefore, the proposed productivity-adjusted CY 2025 home health 
market basket update was 2.5 percent (3.0 percent market basket 
percentage increase, reduced by a 0.5 percentage point productivity 
adjustment). Furthermore, we proposed that if more recent data 
subsequently became available (for example, a more recent estimate of 
the market basket and/or productivity adjustment), we would use such 
data, if appropriate, to determine the CY 2025 market basket percentage 
increase and productivity adjustment in the final rule.
    For this final rule, based on updated data from IGI's third quarter 
2024 forecast with historical data through the second quarter of 2024, 
the 2021-based home health market basket percentage increase for CY 
2025 is 3.2 percent reduced by a 0.5 percentage point productivity 
adjustment which results in a final CY 2025 update percentage of 2.7 
percent.
    Section 1895(b)(3)(B)(v) of the Act requires that the home health 
percentage update be decreased by 2 percentage points for those HHAs 
that do not submit quality data as required by the Secretary. For HHAs 
that do not submit the required quality data for CY 2025, the proposed 
home health payment update percentage was 0.5 percent (2.5 percent 
minus 2 percentage points). For this final rule, for HHAs that do not 
submit the required data for CY 2025, the final home health payment 
update percentage is 0.7 percent (2.7 percent minus 2 percentage 
points).
    We invited public comment on our proposals for the CY 2025 home 
health market basket percentage increase and productivity adjustment.
    Comment: A few commenters stated that they appreciate the market 
basket update and that they support the methodology resulting in a 
proposed positive payment update of 2.5 percent.
    Response: We thank the commenters for their support.
    Comment: Some commenters asserted that the proposed update is not 
enough to account for the increase in costs that home health agencies 
have faced. Commenters stated that home health agencies continue to 
face stubborn and rising inflation which they state affects the costs 
of medical supplies, medications, materials, utilities, transportation, 
as well increases in labor costs. They note that retention and 
recruitment of staff remains a priority,

[[Page 88405]]

but there have been challenges due to personnel shortages and the need 
to compete with other health care sectors, which continues to apply 
upward pressure to the cost of labor. Specifically, a commenter stated 
that their labor costs have increased nearly 12 percent between 2021 
and 2024, and that they are projecting significant future cost 
increases to recruit and retain the workforce necessary to meet rapidly 
increasing demand.
    A commenter suggested CMS examine trends relative to IHS Global 
Inc.'s forecasts to determine whether more recently available data than 
used for the final CY 2025 rule would result in a higher market basket 
update and determine whether additional updates could be made during 
the course of CY 2025 to provide additional support to home health and 
other providers.
    Some commenters stated that since 2021, they believe IGI's 
forecasted growth for the home health market basket has shown a 
consistent trend of under-forecasting actual market basket growth. They 
stated they were cognizant of the fact that forecasts will always be 
imperfect, but the commenters claimed that in the past, they have been 
more balanced. However, with what they state are four straight years of 
under-forecasts, the commenters were concerned that there is a more 
systemic issue with IGI's forecasting. They stated that missed 
forecasts have a significant and permanent impact on providers. The 
commenters claimed that this has resulted in ongoing and permanent 
underpayments to HHAs that is totaling approximately $700 million 
annually.
    The commenters stated that in addition to inaccurate forecasts, the 
underlying market basket itself may have shortcomings that fail to 
properly capture growth. They noted that there has been a very large 
growth in providers' costs in the last several years, and that it is 
confounding how providers with labor-intensive services could have a 
change in the actual market basket growth that is 4 percentage points 
below general inflation as measured by the CPI-U. Commenters urged CMS 
to re-examine the market basket and forecast methodology, and a 
commenter urged CMS to provide greater transparency regarding the 
forecast methodology so that it might benefit from stakeholder input.
    Response: We appreciate the commenters' concerns. We are required 
to update HH PPS payments by the market basket update adjusted for 
productivity, as directed by section 1895(b)(3)(B) of the Act. 
Specifically, section 1895(b)(3)(B)(iii) of the Act states that the 
increase factor shall be based on an appropriate percentage increase in 
a market basket of goods and services included in home health services 
in the same manner as the market basket percentage increase under 
section 1886(b)(3)(B)(iii) of the Act is determined and applied to the 
mix of goods and services comprising inpatient hospital services for 
the fiscal year or year. There is not currently a mechanism in place to 
allow for additional updates during the course of CY 2025, as was 
suggested by the commenter, beyond the percentage increase described 
here.
    The home health market basket is a fixed-weight, Laspeyres-type 
index that measures price changes over time and would not reflect 
increases in costs associated with changes in the volume or intensity 
of input goods and services. As such, the home health market basket 
update would reflect the prospective price pressures described by the 
commenters (such as wage growth or higher energy prices) but would 
inherently not reflect other factors that might increase the level of 
costs, such as the quantity of labor used. We note that cost changes 
(that is, the product of price and quantities) would only be reflected 
when the base year weights are updated to a more recent time period.
    We would also highlight that the market basket percentage increase 
is a forecast of the price pressures that HHAs are expected to face in 
2025. IHS Global Inc. (an Affiliate of S&P Global Inc.) is a nationally 
recognized economic and financial forecasting firm (a participant in 
the Blue Chip Economic Indicators[supreg]) with which CMS contracts to 
forecast the components of the market baskets. While this most recent 
period has been marked by a consistent under forecasting of the market 
basket forecast, over longer periods the forecasts have generally 
averaged close to the historical measures. We note that when developing 
its forecasts of employment cost indices, IHS Global Inc. considers 
overall labor market conditions (including a rise in contract labor 
employment due to tight labor market conditions) as well as trends in 
contract labor wages, which both have an impact on wage pressures for 
workers employed directly by the HHA. CMS will continue to monitor the 
methods associated with the market basket forecasts to ensure there are 
not underlying systematic issues in the forecasting approach.
    While we did not propose to rebase or revise the home health market 
basket in the CY 2025 HH PPS proposed rule, we note that we finalized 
the 2021-based home health market basket in the CY 2024 HH PPS final 
rule (88 FR 77726). At the time of the CY 2024 rulemaking cycle, the 
2021 Medicare cost report data was the most comprehensive data source 
available. While we typically rebase in regular intervals (roughly 
every four years), we monitor the Medicare cost report data to assess 
whether rebasing on a more frequent schedule is technically 
appropriate, and we will continue to do so in the future. In addition, 
we welcome any suggestions for technical improvements to the home 
health market basket and note that any changes would be proposed and 
established through notice and comment rulemaking.
    At the time of the CY 2025 HH PPS proposed rule, based on the IHS 
Global Inc. first quarter 2024 forecast with historical data through 
the fourth quarter of 2023, the 2021-based home health market basket 
update was forecasted to be 3.0 percent for CY 2025, reflecting 
forecasted compensation price growth of 3.4 percent. This reflects an 
expectation that the growth in compensation costs will ease relative to 
the 2021-2023 period but remain elevated relative to historical 
compensation growth rates (which averaged 2.1 percent in the 10-year 
period from 2011 through 2020). We appreciate the commenter's concern 
regarding inflationary pressure and the request to use more recent data 
to determine the CY 2025 home health market basket update. In the CY 
2025 HH PPS proposed rule, we proposed that if more recent data became 
available, we would use such data, if appropriate, to derive the final 
CY 2025 home health market basket update for the final rule. For this 
final rule, we now have an updated forecast of the price proxies 
underlying the market basket that incorporates more recent historical 
data and reflects a revised outlook regarding the U.S. economy and 
expected price inflation for CY 2025. Based on IHS Global Inc.'s third 
quarter 2024 forecast with historical data through the second quarter 
of 2024, we are projecting a CY 2025 home health market basket update 
of 3.2 percent (reflecting forecasted compensation price growth of 3.5 
percent) and a productivity adjustment of 0.5 percentage point. 
Therefore, for CY 2025 a final productivity-adjusted home health market 
basket update of 2.7 percent (3.2 percent reduced by 0.5 percentage 
point) will be applicable, compared to the 2.5 percent productivity-
adjusted home health market basket update that was proposed.

[[Page 88406]]

    Comment: Several commenters stated that CMS should recognize the 
financial impact of its forecasting error with respect to the annual 
Market Basket Index updates from 2021 and 2022 and exercise its 
authority to implement a one-time adjustment of 5.2 percent to account 
for the forecasting error. A few commenters suggested alternative 
forecast error adjustments ranging from approximately 4.4 to 5.7 
percent to account for under forecasts in the period from 2021 through 
2023.
    Response: The home health market basket updates are set 
prospectively, which means that the update relies on a mix of both 
historical data for part of the period for which the update is 
calculated and forecasted data for the remainder. For instance, the CY 
2025 market basket update in this final rule reflects historical data 
through the second quarter of CY 2024 and forecasted data from the 
third quarter of CY 2024 through the fourth quarter of CY 2025. There 
is currently no mechanism to adjust for market basket forecast error in 
the home health payment update. A forecast error for a market basket 
update is equal to the actual market basket percentage increase for a 
given year less the forecasted market basket percentage increase. Due 
to the uncertainty regarding future price trends, forecast errors can 
be both positive and negative, as has occurred since the implementation 
of the HH PPS.
    Over most of this history the forecast errors were smaller in 
magnitude, with the largest error prior to 2021 being an over forecast 
of 1.2 percentage points in 2009. More recently the home health market 
basket has been under forecast, as noted by the commenters, with larger 
errors occurring for 2021 through 2023. The cumulative forecast error 
since HH PPS inception (fiscal year 2002 to CY 2023, excluding CY 2018 
and CY 2020 when the market basket update was statutorily mandated) is 
-0.7 percent. The recent forecast errors were largely a function of 
uncertainty in the overall economy and the health sector specifically 
due to the nature of the public health emergency and the unforeseen 
rapidly accelerating inflationary environment.
    For this final rule, we have incorporated more recent historical 
data and forecasts to capture the price and wage pressures facing HHAs 
and believe it is the best available projection of inflation to 
determine the applicable percentage increase for the HHA payments in CY 
2025.
    Comment: A commenter stated they are disappointed that CMS has not 
taken increased workforce safety costs into consideration. They 
indicated that workforce safety is an area of growing concern for the 
home health industry at large and it will take significant investments 
in training, security and equipment to keep home health clinicians safe 
while working in the home and community. The commenter stated that 
there is currently no area to report many of these unique environmental 
and safety costs on the Medicare cost report. The commenter stated that 
they believe that CMS needs to work with the home health industry to 
ensure that workplace safety costs and other unique expenditures 
related to home health are considered when determining the home health 
payment rate update.
    Response: We recognize the importance of ensuring workforce safety. 
CMS reminds commenters that these costs may be recorded under the Plant 
Operation & Maintenance cost center, which includes costs associated 
with ``protecting employees, visitors, and HHA property.''
    As detailed in the CY 2024 HH PPS final rule (88 FR 77728), costs 
recorded in the overhead cost centers are used to derive the major cost 
weights, and thus any significant changes in the volume or intensity of 
investment since the base year (currently 2021) would be a factor in 
the cost weights when the home health market basket is next rebased.
    Final Decision: After consideration of public comments, we are 
finalizing the home health payment update percentage for CY 2025 based 
on the most recent forecast of the home health market basket percentage 
increase and productivity adjustment at the time of rulemaking. Based 
on IHS Global Inc.'s third quarter 2024 forecast with historical data 
through the second quarter of 2024, we are projecting a CY 2025 home 
health market basket update of 3.2 percent and a productivity 
adjustment of 0.5 percentage point. Therefore, we are finalizing for CY 
2025 a final productivity-adjusted home health market basket update of 
2.7 percent (3.2 percent reduced by 0.5 percentage point).
2. Adoption of the CBSA Delineations for the HH PPS Wage Index
    In general, OMB issues major revisions to statistical areas every 
10 years, based on the results of the decennial census. However, OMB 
occasionally issues minor updates and revisions to statistical areas in 
the years between the decennial censuses.
    On February 28, 2013, OMB issued Bulletin No. 13-01, announcing 
revisions to the delineations of MSAs, Micropolitan Statistical Areas, 
and CBSAs, and guidance on uses of the delineation of these areas. In 
the CY 2015 HH PPS final rule (79 FR 66085 through 66087), we adopted 
OMB's area delineations using a 1-year transition.
    On August 15, 2017, OMB issued Bulletin No. 17-01 in which it 
announced that one Micropolitan Statistical Area, Twin Falls, Idaho, 
now qualifies as a Metropolitan Statistical Area. The new CBSA (46300) 
comprises the principal city of Twin Falls, Idaho in Jerome County, 
Idaho and Twin Falls County, Idaho. The CY 2025 HH PPS wage index value 
for CBSA 46300, Twin Falls, Idaho, will be 0.8519. Bulletin No. 17-01 
is available at https://www.whitehouse.gov/wp-content/uploads/legacy_drupal_files/omb/bulletins/2017/b-17-01.pdf.
    On April 10, 2018, OMB issued OMB Bulletin No. 18-03, which 
superseded the August 15, 2017, OMB Bulletin No. 17-01. On September 
14, 2018, OMB issued OMB Bulletin No. 18-04 which superseded the April 
10, 2018, OMB Bulletin No. 18-03. These bulletins established revised 
delineations for Metropolitan Statistical Areas, Micropolitan 
Statistical Areas, and Combined Statistical Areas, and provided 
guidance on the use of the delineations of these statistical areas. A 
copy of OMB Bulletin No. 18-04 may be obtained at https://www.bls.gov/bls/omb-bulletin-18-04-revised-delineations-of-metropolitan-statistical-areas.pdf.
    On March 6, 2020, OMB issued Bulletin No. 20-01, which provided 
updates to and superseded OMB Bulletin No. 18-04 that was issued on 
September 14, 2018. The attachments to OMB Bulletin No. 20-01 provided 
detailed information on the update to statistical areas since September 
14, 2018, and were based on the application of the 2010 Standards for 
Delineating Metropolitan and Micropolitan Statistical Areas to Census 
Bureau population estimates for July 1, 2017, and July 1, 2018. (For a 
copy of this bulletin, we refer readers to https://www.whitehouse.gov/wp-content/uploads/2020/03/Bulletin-20-01.pdf.) In OMB Bulletin No. 20-
01, OMB announced one new Micropolitan Statistical Area, one new 
component of an existing Combined Statistical Area and changes to New 
England City and Town Area (NECTA) delineations. In the CY 2021 HH PPS 
final rule (85 FR 70298), we stated that if appropriate, we will 
propose any updates from OMB Bulletin No. 20-01 in future rulemaking. 
After reviewing OMB Bulletin No. 20-01, we determined that the changes 
in Bulletin 20-01 encompassed delineation changes that

[[Page 88407]]

did not affect the Medicare home health wage index for CY 2022. 
Specifically, the updates consisted of changes to NECTA delineations 
and the re-designation of a single rural county into a newly created 
Micropolitan Statistical Area. The Medicare home health wage index does 
not utilize NECTA definitions, and, as most recently discussed in the 
CY 2021 HH PPS final rule (85 FR 70298) we include hospitals located in 
Micropolitan Statistical areas in each State's rural wage index. In 
other words, these OMB updates did not affect any geographic areas for 
purposes of the HH PPS wage index calculation.
    In the CY 2021 HH PPS final rule (85 FR 70298), we finalized our 
proposal to adopt the revised OMB delineations with a 5-percent cap on 
wage index decreases in CY 2021. In the CY 2023 HH PPS final rule (87 
FR 66851 through 66853), we finalized a policy that the CY HH PPS wage 
index will include a permanent 5-percent cap on wage index decreases 
for CY 2023 and each subsequent year. Specifically, we finalized for CY 
2023 and subsequent years, the application of a permanent 5-percent cap 
on any decrease to a geographic area's wage index from its wage index 
in the prior year, regardless of the circumstances causing the decline. 
That is, we finalized a policy requiring that a geographic area's wage 
index for CY 2023 will not be less than 95 percent of its final wage 
index for CY 2022, regardless of whether the geographic area is part of 
an updated CBSA, and that for subsequent years, a geographic area's 
wage index will not be less than 95 percent of its wage index 
calculated in the prior CY. Previously this methodology was applied to 
all the counties that make up a CBSA or statewide rural area. However, 
as discussed in section II.E.2. of this final rule, because we proposed 
to adopt the revised OMB delineations, we also proposed that this 
methodology would also be applied to individual counties.
    On July 21, 2023, OMB issued Bulletin No. 23-01, which updates and 
supersedes OMB Bulletin No. 20-01, issued on March 6, 2020. OMB 
Bulletin No. 23-01 establishes revised delineations for the MSAs, 
Micropolitan Statistical Areas, Combined Statistical Areas, and 
Metropolitan Divisions, collectively referred to as Core Based 
Statistical Areas (CBSAs). According to OMB, the delineations reflect 
the 2020 Standards for Delineating Core Based Statistical Areas (CBSAs) 
(the ``2020 Standards''), which appeared in the Federal Register (86 FR 
37770 through 37778) on July 16, 2021, and application of those 
standards to Census Bureau population and journey-to-work data (for 
example, 2020 Decennial Census, American Community Survey, and Census 
Population Estimates Program data). A copy of OMB Bulletin No. 23-01 is 
available online at https://www.whitehouse.gov/wp-content/uploads/2023/07/OMB-Bulletin-23-01.pdf. The July 21, 2023, OMB Bulletin No. 23-01 
contains a number of significant changes. For example, there are new 
CBSAs, urban counties that have become rural, rural counties that have 
become urban, and existing CBSAs that have been split apart. We believe 
it is important for the HH PPS wage index to use the latest OMB 
delineations available in order to maintain a more accurate and up-to-
date payment system that reflects the reality of population shifts and 
labor market conditions. We further believe that using the most current 
OMB delineations will increase the integrity of the HH PPS wage index 
by creating a more accurate representation of geographic variation in 
wage levels. We proposed to implement the new OMB delineations as 
described in the July 21, 2023, OMB Bulletin No. 23-01 for the HH PPS 
wage index effective beginning in CY 2025. The proposal was also 
consistent with the proposals to adopt the revised OMB delineations in 
the IPPS and other post-acute care payment systems.
a. Micropolitan Statistical Areas
    As discussed in the CY 2006 HH PPS proposed rule (70 FR 40788) and 
final rule (70 FR 68132), CMS considered how to use the Micropolitan 
statistical area definitions in the calculation of the wage index. At 
the time, OMB defined a ``Micropolitan Statistical Area'' as a CBSA 
associated with at least one urban cluster that has a population of at 
least 10,000, but less than 50,000 (75 FR 37252). We referred to these 
as Micropolitan Areas. After extensive impact analysis, consistent with 
the treatment of these areas under the IPPS as discussed in the fiscal 
year (FY) 2005 IPPS final rule (69 FR 49029 through 49032), we 
determined the best course of action will be to treat Micropolitan 
Areas as ``rural'' and include them in the calculation of each state's 
home health rural wage index (see 70 FR 40788 and 70 FR 68132). Thus, 
the HH PPS statewide rural wage index is determined using IPPS hospital 
data from hospitals located in non-Metropolitan Statistical Areas 
(MSAs). In the CY 2021 HH PPS final rule (85 FR 70298), we finalized a 
policy to continue to treat Micropolitan Areas as ``rural'' and to 
include Micropolitan Areas in the calculation of each state's rural 
wage index.
    The OMB ``2020 Standards'' continue to define a ``Micropolitan 
Statistical Area'' as a CBSA with at least one urban area that has a 
population of at least 10,000, but less than 50,000. The Micropolitan 
Statistical Area comprises the central county or counties containing 
the core, plus adjacent outlying counties having a high degree of 
social and economic integration with the central county, or counties as 
measured through commuting (86 FR 37778). Overall, there are the same 
number of Micropolitan Areas (542) under the new OMB delineations based 
on the 2020 Census as there were using the 2010 Census. We note, 
however, that a number of urban counties have switched status and have 
joined or become Micropolitan Areas, and some counties that once were 
part of a Micropolitan Area, and thus were treated as rural, have 
become urban based on the 2020 Decennial Census data. In the CY 2025 HH 
PPS proposed rule, we stated that we believe that the best course of 
action would be to continue our established policy and include 
Micropolitan Areas in each state's rural wage index as these areas 
continue to be defined as having relatively small urban cores 
(populations of 10,000 to 49,999) (89 FR 55364). Therefore, in 
conjunction with our proposal to implement the new OMB labor market 
delineations beginning in CY 2025, and consistent with the treatment of 
Micropolitan Areas under the IPPS, we also proposed to continue to 
treat Micropolitan Areas as ``rural'' and to include Micropolitan Areas 
in the calculation of each state's rural wage index.
    Final Decision: We did not receive any comments on our proposal to 
continue to treat Micropolitan Areas as rural and to include those 
areas in the calculation of each State's rural wage index. We are 
finalizing this policy as proposed.
b. Change to County-Equivalents in the State of Connecticut
    In a June 6, 2022, Federal Register notice (87 FR 34235 through 
34240), the Census Bureau announced that it was implementing the State 
of Connecticut's request to replace the eight counties in the State 
with nine new ``Planning Regions.'' Planning regions are included in 
OMB Bulletin No. 23-01 and now serve as county-equivalents within the 
CBSA system. We evaluated the change and proposed to adopt the planning 
regions as county equivalents for wage index purposes. We believe it is 
necessary to adopt this migration from counties to planning region 
county-equivalents in order to maintain

[[Page 88408]]

consistency with our established policy of adopting the most recent OMB 
updates. We provided the crosswalk in table 26 of the proposed rule (89 
FR 55364) for counties located in Connecticut with the current and 
proposed Federal Information Processing Series (FIPS) county and 
county-equivalent codes and CBSA assignments.
[GRAPHIC] [TIFF OMITTED] TR07NO24.041

    Final Decision: We did not receive any comments on our proposal to 
adopt the Connecticut planning regions as county equivalents for wage 
index purposes. We are finalizing this policy as proposed. The 
crosswalk in table 13 includes counties located in Connecticut with the 
current and final FIPS county and county-equivalent codes and CBSA/
transition code assignments.
c. Urban Counties That Will Become Rural
    In the CY 2025 HH PPS proposed rule, we inadvertently omitted 
Windham County, CT from the list of counties that would become rural 
under the revised OMB statistical area delineations (based upon OMB 
Bulletin No. 23-01). For this final rule, Windham County has been 
included. Therefore, there are a total of 54 counties (and county 
equivalents) that are currently considered urban that will be 
considered rural beginning in CY 2025. Table 14 lists the 54 counties 
that will become rural if we finalize our proposal to implement the 
revised OMB delineations.

[[Page 88409]]

[GRAPHIC] [TIFF OMITTED] TR07NO24.042

    We invited public comment on our proposal to redesignate the urban 
counties in table 14 as rural based on the revised OMB delineations 
from OMB Bulletin No. 23-01.

[[Page 88410]]

    Comment: Several commenters expressed concern with the proposal to 
redesignate urban counties as rural based on the revised delineations 
from OMB Bulletin No. 23-01. A few commenters stated that changes to 
the wage index that would move some agencies from an urban designation 
to a rural one would further reduce agency reimbursement at a time when 
rural agencies are facing increased challenges recruiting and retaining 
employees. Another commenter stated that utilizing the revised OMB data 
for the CBSAs results in even more disparity between urban and rural 
agencies than there was under the prior delineations. This commenter 
stated that the one-year wage index cap of 5 percent is insufficient to 
mitigate rate decreases and that many newly classified rural agencies 
will be severely impacted.
    Response: We appreciate the concerns raised by the commenters. 
However, we continue to believe it is important for the HH PPS wage 
index to use the latest OMB delineations available in order to maintain 
a more accurate and up-to-date payment system that reflects the reality 
of population shifts and labor market conditions. We note that unlike 
other payment systems, the appropriate home health wage index value is 
applied to the labor portion of the HH PPS rates based on the site of 
service for the beneficiary (defined by section 1861(m) of the Act) and 
not the agency's location. While some urban counties are becoming rural 
based on the revised delineations, HHAs are able to serve beneficiaries 
in more than one county including counties that remain designated as 
urban. Furthermore, as discussed later in this final rule, we believe 
that applying the permanent 5-percent cap policy at the county level 
would mitigate potential negative impacts experienced by HHAs who 
provide services in counties that have been redesignated as rural. We 
proposed to apply the permanent 5-percent cap at the county level so 
that counties that move from a CBSA or statewide rural area with a 
higher wage index value into a new CBSA or rural area with a lower wage 
index value will have a CY 2025 wage index that is not less than 95 
percent of the county's CY 2024 wage index value under the old 
delineation, despite moving into a new delineation with a lower wage 
index. We also proposed that the 5-percent cap would continue to be 
applied in these counties until a county's current calendar year wage 
index under the revised delineations is not less than 95 percent of the 
wage index from the previous calendar year. Therefore, we believe the 
5-percent cap applied at the county level is sufficient to mitigate any 
negative impacts of adopting the revised delineations.
    Final Decision: After consideration of public comments, we are 
finalizing the proposal to redesignate the 54 urban counties listed in 
table 14 as rural for purposes of the HH PPS wage index beginning in CY 
2025.
d. Rural Counties That Will Become Urban
    Under the revised OMB statistical area delineations (based upon OMB 
Bulletin No. 23-01), a total of 54 counties (and county equivalents) 
that are currently located in rural areas will be considered located in 
urban areas under the revised OMB delineations beginning in CY 2025. 
Table 15 lists the 54 counties that will be urban if we finalize our 
proposal to implement the revised OMB delineations.

[[Page 88411]]

[GRAPHIC] [TIFF OMITTED] TR07NO24.043

    Final Decision: We did not receive public comments on our proposal 
to redesignate the 54 rural counties listed in table 15 as urban based 
on the revised OMB delineations from OMB Bulletin No. 23-01. Therefore, 
we are finalizing the policy as proposed.
e. Urban Counties That Will Move to a Different Urban CBSA Under the 
Revised OMB Delineations
    In addition to some rural counties becoming urban and some urban 
counties becoming rural, several urban counties will shift from one 
urban CBSA to a new or existing urban CBSA under our proposal to adopt 
the revised OMB delineations. In other cases, applying the new OMB 
delineations will involve a change only in CBSA name or number, while 
the CBSA will continue to encompass the same constituent counties. For 
example, CBSA 35154 (New Brunswick-Lakewood, NJ) will experience both a 
change to its number and its name and become CBSA 29484

[[Page 88412]]

(Lakewood-New Brunswick, NJ), while all three of its constituent 
counties will remain the same. In other cases, only the name of the 
CBSA will be modified. Table 16 lists CBSAs that will change in name 
and/or CBSA number only, but the constituent counties will not change 
(except in instances where an urban county became rural or a rural 
county became urban, as discussed in the previous section).
BILLING CODE 4120-01-P

[[Page 88413]]

[GRAPHIC] [TIFF OMITTED] TR07NO24.044

    In some cases, all urban counties from a CY 2024 CBSA will be moved 
and subsumed by another CBSA in CY 2025. Table 17 lists the CBSAs that, 
under our proposal to adopt the revised OMB

[[Page 88414]]

statistical area delineations, will be subsumed by another CBSA.
[GRAPHIC] [TIFF OMITTED] TR07NO24.045

    In other cases, if we adopt the new OMB delineations, some counties 
will shift between existing and new CBSAs, changing the constituent 
makeup of the CBSAs. In another type of change, some CBSAs have 
counties that will split off to become part of, or to form entirely new 
labor market areas. For example, the District of Columbia, DC, Charles 
County, MD and Prince Georges County, MD will move from CBSA 47894 
(Washington-Arlington-Alexandria, DC-VA-MD-WV) into CBSA 47764 
(Washington, DC-Md). Calvert County, MD will move from CBSA 47894 
(Washington-Arlington-Alexandria, DC-VA-MD-WV) into CBSA 30500 
(Lexington Park, MD). The remaining counties that currently make up 
47894 (Washington-Arlington-Alexandria, DC-VA-MD-WV) will move into 
CBSA 11694 (Arlington-Alexandria-Reston, VA-WV). Finally, in some 
cases, a CBSA will lose counties to another existing CBSA if we adopt 
the new OMB delineations. For example, Grainger County, TN will move 
from CBSA 34100 (Morristown, TN) into CBSA 28940 (Knoxville, TN). Table 
18 lists the 73 urban counties that will move from one urban CBSA to a 
new or modified urban CBSA if we adopt the revised OMB delineations.

[[Page 88415]]

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[[Page 88416]]


[GRAPHIC] [TIFF OMITTED] TR07NO24.047

BILLING CODE 4120-01-C

[[Page 88417]]

    A summary of the general comments on our proposals to adopt the 
revised delineations from OMB Bulletin No. 23-01 appears below:
    Comment: Some commenters, including MedPAC, were generally 
supportive of the proposals to adopt the revised delineations from OMB 
Bulletin No. 23-01. A commenter expressed support for the proposal to 
adopt the new OMB delineations as described in OMB Bulletin 23-01 for 
the HH PPS wage index effective beginning in CY 2025. This commenter 
agreed that using the most current OMB delineations would increase the 
integrity of the HH PPS wage index by creating a more accurate 
representation of geographic variations in wage levels. Another 
commenter stated that until a new home health wage index can be 
implemented, the commenter supports CMS' proposal to continue using 
OMB's most recent statistical area delineations for the hospital wage 
index.
    Response: We thank the commenters for their support.
    Comment: A commenter opposed what they describe as the automatic 
adoption of the revised OMB delineations. This commenter stated that 
adopting the new delineations by default is in opposition to both OMB 
guidance and the Metropolitan Areas Protection and Standardization Act 
of 2021 (MAPs Act). This commenter stated that CMS has not provided any 
rationale or explanation for why relying on the updated CBSAs is 
appropriate and that rather than simply adopting the OMB CBSAs by 
default, CMS must make a fact-specific determination of those CBSAs' 
suitability for Medicare payment purposes, including whether it would 
be appropriate to use additional data to modify OMB's delineation to 
ensure that such changes are appropriate for purposes of defining 
regional labor markets for home health workers.
    Response: We acknowledge the commenter's concerns about adopting 
CBSA changes. We do not agree with the commenter's assertion that this 
is ``by default'' or that CMS has not provided rationale for the 
proposed adoption of the revised CBSA delineations for CY 2025. The 
MAPS Act specifically states that ``this act limits the automatic 
application of, and directs the Office of Management and Budget (OMB) 
to provide information about, changes to the standards for designating 
a core-based statistical area (CBSA) . . .'' We believe our proposed 
rule meets the requirements of the MAPS Act, because we have not 
automatically applied the revised CBSAs outlined in OMB Bulletin 23-01. 
Rather, through notice and comment rulemaking, we proposed the adoption 
of the revised CBSA delineations. Further, we stated our rationale for 
adopting the revised CBSA delineations, in that we believe it is 
important for the HH PPS to use, as soon as is reasonably possible, the 
latest available labor market area delineations to maintain a more 
accurate and up-to date payment system that reflects the reality of 
population shifts and labor market conditions. We also stated that we 
believe that using the most current delineations would increase the 
integrity of the HH PPS wage index system by creating a more accurate 
representation of geographic variations in wage levels. With respect to 
the suggestion that CMS consider whether it would be appropriate to use 
additional data to ensure that such changes are appropriate for 
purposes of defining regional labor markets for home health workers, we 
do not believe use of such additional analysis is necessary. Using the 
latest available labor market area delineations based on the latest 
available CBSA delineations established by OMB inherently reflects 
current population and labor market conditions and as such, results in 
a more accurate payment system.
    Comment: A few commenters expressed concern with specific 
redesignations in their areas. A commenter stated that the proposed 
adoption of the latest OMB delineations for the home health wage index 
will significantly impact several Florida regions and that high-cost 
areas such as Miami-Fort Lauderdale-West Palm Beach, Tampa-St. 
Petersburg-Clearwater, and Orlando-Kissimmee-Sanford are likely to 
experience notable reductions in their wage index values. This 
commenter recommended that CMS reconsider the proposed adoption of the 
new delineations by accounting for the distinctive economic and 
demographic factors influencing high-cost regions in Florida.
    Several commenters opposed the delineation change for rural Puerto 
Rico where there is now a hospital in rural Puerto Rico from which 
hospital wage data can be derived. These commenters stated the payment 
calculations to providers will ultimately be reduced by 20.64 percent 
when using a wage index of 0.2520 vs 0.4047. The commenters stated that 
providers are unable to operate at a 20 percent reduction, particularly 
in the face of increasing costs and expressed concern that this 
reduction will lead to adverse impacts for beneficiaries as the labor 
market further shrinks and healthcare workers exit the Puerto Rico 
market for other areas or industries.
    A commenter opposed the impact of the adoption of the revised 
delineations in Nassau, Suffolk, and Westchester Counties in New York 
state. This commenter requested CMS consider the impact of the wage 
index changes on Core-Based Statistical Areas (CBSAs) with increasing 
labor costs and the impact of these reductions on hospice, home health, 
and other home-and community-based providers in relation to 
institutional care providers
    Another commenter expressed concern about the impact of county 
reclassifications on home health agencies serving Dukes and Nantucket 
Counties in Massachusetts. The commenter stated that as a result of the 
reclassification of Franklin County, the wage index for Dukes and 
Nantucket counties has dropped by 10 percent in the last 2 years and 
would drop an additional 10 percent over the next 2 years and that 
Medicare beneficiaries on those island communities are already 
experiencing limited access to home health services. The commenter 
stated that the proposed 5 percent cut will exacerbate that access 
problem and recommended CMS reverse the proposed 5 percent cut to the 
wage index for Dukes and Nantucket Counties to preserve access to home 
health services in those counties.
    Response: We appreciate the concerns expressed by commenters 
regarding specific impacts of implementing the revised designations. 
While we understand these concerns, we believe that implementing the 
revised OMB delineations will create more accurate representations of 
labor market areas nationally and result in home health wage index 
values being more representative of the actual costs of labor in a 
given area. Although these comments only addressed the negative impact 
on certain areas, it is important to note that there are many 
geographic locations and home health providers that will experience 
positive impacts upon implementation of the revised CBSA designations. 
We acknowledge there are areas that will experience a decrease in their 
wage index but believe that the permanent 5-percent cap policy provides 
an adequate safeguard against any significant payment reductions in CY 
2025 while improving the accuracy of the payment adjustment for 
differences in area wage levels. Therefore, we believe that it is 
appropriate to implement the new OMB delineations without further 
delay.
    Final Decision: We are finalizing our proposals to adopt the 
revised OMB

[[Page 88418]]

delineations from OMB Bulletin No. 23-01.
f. Transition Period
    In the past we have provided for transition periods when adopting 
changes that have significant payment implications, particularly large 
negative impacts, in order to mitigate the potential impacts of 
proposed home health policies. For example, we have proposed and 
finalized budget-neutral transition policies to help mitigate negative 
impacts on HHAs following the adoption of the new CBSA delineations 
based on the 2010 Decennial Census data in the CY 2015 HH PPS final 
rule (79 FR 66032). Specifically, we implemented a 1-year 50/50 blended 
wage to the new OMB delineations. We applied a blended wage index for 1 
year (CY 2015) for all geographic areas that will consist of a 50/50 
blend of the wage index values using OMB's old area delineations and 
the wage index values using OMB's new area delineations. That is, for 
each county, a blended wage index was calculated equal to 50 percent of 
the CY 2015 wage index using the old labor market area delineation and 
50 percent of the CY 2015 wage index using the new labor market area 
delineation, which resulted in an average of the two values. 
Additionally, in the CY 2021 HH PPS final rule (85 FR 70312), we 
proposed and finalized a transition policy to apply a 5-percent cap on 
any decrease in a geographic area's wage index value from the wage 
index value from the prior CY. This transition allowed the effects of 
our adoption of the revised CBSA delineations from OMB Bulletin 18-04 
to be phased in over 2 years, where the estimated reduction in a 
geographic area's wage index was capped at five percent in CY 2021 
(that is, no cap was applied to the reduction in the wage index for the 
second year (CY 2022)). We explained that we believed a 5-percent cap 
on the overall decrease in a geographic area's wage index value will be 
appropriate for CY 2021, as it provided predictability in payment 
levels from CY 2020 to CY 2021 and additional transparency because it 
was administratively simpler than our prior one-year 50/50 blended wage 
index approach.
    In the CY 2023 HH PPS final rule (87 FR 66851 through 66853), we 
adopted a permanent 5-percent cap on wage index decreases beginning in 
CY 2023 and each subsequent year. The policy applies a permanent 5-
percent cap on any decrease to a geographic area's wage index from its 
wage index in the prior year, regardless of the circumstances causing 
the decline, so that a geographic area's wage index will not be less 
than 95 percent of its wage index calculated in the prior CY.
    In the CY 2025 HH PPS proposed rule, we stated that the permanent 
5-percent cap on wage index decreases would be sufficient to mitigate 
any potential negative impact caused by adopting the revised OMB 
delineations and that no further transition is necessary. Previously, 
the 5-percent cap had been applied at the CBSA or statewide rural area 
level, meaning that all the counties that make up the CBSA or rural 
area received the 5-percent cap. However, for CY 2025, to mitigate any 
potential negative impact caused by the adoption of the revised 
delineations, we proposed that in addition to the 5-percent cap being 
calculated for an entire CBSA or statewide rural, the cap would also be 
calculated at the county level, so that individual counties moving to a 
new delineation will not experience more than a five percent decrease 
in wage index from the previous calendar year. Specifically, we 
proposed for CY 2025, that the 5-percent cap will also be applied to 
counties that would move from a CBSA or statewide rural area with a 
higher wage index value into a new CBSA or rural area with a lower wage 
index value, so that the county's CY 2025 wage index would not be less 
than 95 percent of the county's CY 2024 wage index value under the old 
delineation despite moving into a new delineation with a lower wage 
index.
    Due to the way that we proposed to calculate the 5-percent cap for 
counties that experience an OMB designation change, some CBSAs and 
statewide rural areas could have more than one wage index value because 
of the potential for their constituent counties to have different wage 
index values after the redesignation. Specifically, some counties that 
change OMB designations will have a wage index value that is different 
than the wage index value assigned to the other constituent counties 
that make up the CBSA or statewide rural area that they are moving into 
because of the application of the 5-percent cap. However, for home 
health claims processing, each CBSA or statewide rural area can have 
only one wage index value assigned to that CBSA or statewide rural 
area.
    Therefore, HHAs that serve beneficiaries in a county that will 
receive the cap will need to use a number other than the CBSA or 
statewide rural area number to identify the county's appropriate wage 
index value on home health claims in CY 2025. We proposed that 
beginning in CY 2025, counties that have a different wage index value 
than the CBSA or rural area into which they are designated after the 
application of the 5-percent cap will use a wage index transition code. 
These special codes are five digits in length and begin with ``50'' and 
the remaining digits are unique for that code. We are using ``Xs'' to 
show how the transition codes could be labeled. The 50XXX \11\ wage 
index transition codes will be used only in specific counties; counties 
located in CBSAs and rural areas that do not correspond to a different 
transition wage index value will still use the CBSA number. For 
example, FIPS county 13171 Lamar County, GA is currently part of CBSA 
12060 Atlanta-Sandy Springs-Alpharetta. However, for CY 2025 we 
proposed that Lamar County will be redesignated into the Rural Georgia 
Code 99911. Because the wage index value of rural Georgia is more than 
a 5-percent decrease from the wage index value that Lamar County 
previously received under CBSA 12060, the CY 2025 wage index for Lamar 
County will be capped at 95 percent of the CY 2024 wage index value for 
CBSA 12060. Additionally, because rural Georgia can only have one wage 
index value assigned to code 99911, in order for Lamar County to 
receive the capped wage index for CY 2025, a transition code will be 
used on a home health claim instead of rural Georgia code 99911.
---------------------------------------------------------------------------

    \11\ The remaining 3 characters of the code to be determined if 
finalized.
---------------------------------------------------------------------------

    We also proposed that the 5-percent cap would apply to a county 
that corresponds to a different wage index value than the wage index 
value in the CBSA or rural area in which they are designated due to a 
delineation change until the county's new wage index is more than 95 
percent of the wage index from the previous calendar year. Therefore, 
in order to capture the correct wage index value, an HHA will continue 
to use the assigned 50XXX transition code for the county until the 
county's wage index value calculated for that calendar year using the 
new OMB delineations is not less than 95 percent of the county's capped 
wage index from the previous calendar year. Thus, in the example 
mentioned earlier, claims for Lamar County will use the assigned 
transition code until the wage index in its revised designation of 
Rural Georgia is equal to or more than 95 percent of its wage index 
value from the previous calendar year.
    The final counties that will require a transition code and the 
corresponding 50XXX codes are shown in table 19 and will also be shown 
in the CY 2025 HH

[[Page 88419]]

PPS wage index file. Table 19 includes a list of counties that have 
changed designation and must use a transition code beginning in CY 
2025. This list is comprised of counties that are redesignated into a 
new CBSA or rural area and will receive the 5-percent cap on wage index 
decreases. These counties must use a transition code because the wage 
index for that county is higher than all other constituent counties 
that make up the CBSA or rural area (like the earlier example for Lamar 
County, GA). Additionally, the list also includes counties that move 
into a new CBSA or rural area and have a different wage index value 
because the constituent counties that make up the CBSA or rural receive 
the 5-percent cap for CY 2025 while the county that moves into the CBSA 
or rural area does not. For example, rural area 99922 rural 
Massachusetts is comprised of FIPS code 25007 Dukes County, FIPS code 
25019 Nantucket County and the redesignated FIPS code 25011 Franklin 
County. Dukes County and Nantucket County were part of rural area 99922 
Massachusetts for CY 2024 and will receive the 5-percent cap because 
the CY 2025 wage index for rural area 99922 is more than a 5-percent 
decrease from the CY 2024 wage index for rural area 99922. However, 
Franklin County was included in CBSA 44140 Springfield, MA, in FY 2024 
and the uncapped CY 2025 wage index for rural area 99922 is higher than 
the CY 2024 wage index for CBSA 44140. In this example, Franklin 
County, MA, would receive the uncapped wage index for rural Area 99922 
while Dukes and Nantucket counties receive the 5-percent capped wage 
index. Therefore, HHAs that serve beneficiaries in Franklin County, MA, 
must use the transition code 50012 on home health claims instead of 
rural area 99922 Rural Massachusetts.
BILLING CODE 4120-01-P

[[Page 88420]]

[GRAPHIC] [TIFF OMITTED] TR07NO24.048

BILLING CODE 4120-01-C

[[Page 88421]]

    The following is a summary of the comments on the proposal to use 
the permanent 5-percent cap applied at the county level as a 
transition.
    Comment: A few commenters were supportive of the use of the 
permanent 5-percent cap to mitigate any adverse effects of adopting the 
revised OMB delineations. MedPAC stated that the Commission supports 
having a policy to cap and phase in the wage index reductions that a 
provider can experience in a given year. Another commenter thanked CMS 
for implementing the 5-percent cap on wage index decreases as a policy 
to combat ongoing wage index inequities.
    Response: We appreciate the commenters support.
    Comment: A few commenters recommended other changes to the 
finalized 5-percent cap policy. MedPAC recommended that the cap should 
be applied to both increases and decreases in a given year. Several 
commenters recommended that the cap be lowered to two percent, while a 
commenter suggested the cap should be no more than three percent. A 
commenter requested that CMS institute a one-time zero wage index 
adjustment in all CBSAs where there is a negative adjustment, while 
another commenter recommended that the 5-percent cap should be 
implemented in a non-budget neutral manner.
    A commenter stated that the 5-percent cap is helpful as a general 
measure to stabilize wage index values from year to year, but that does 
not negate the need to implement a transition period specific to wage 
index changes resulting from revised CBSA delineations. This commenter 
recommended a three-year transition period to allow for a wage index 
transition consistent with prior updates to the CBSA categorization due 
to OMB updates.
    Response: We appreciate commenters recommendations for changes to 
the finalized cap policy. However, in the CY 2025 HH PPS proposed rule, 
we did not propose to make changes to the finalized 5-percent cap 
policy outside of the proposal to apply the 5-percent cap at the county 
level. Therefore, these comments are outside the scope of the proposed 
rule. Any changes to the finalized cap policy beyond the proposal to 
apply the cap at the county level would need to go through notice and 
comment rulemaking. We continue to believe that a 5-percent cap would 
most effectively mitigate any significant decreases in a geographic 
area's wage index for a calendar year, while still balancing the 
importance of ensuring that area wage index values accurately reflect 
relative differences in area wage levels. Furthermore, we believe that 
the 5-percent cap on wage index decreases provides a degree of 
predictability in payment changes for providers and allows providers 
time to adjust to any significant decreases they may face year to year. 
Therefore, we do not believe that any transition is appropriate at this 
time.
    Comment: A commenter expressed support for the proposal to apply 
the 5-percent cap at the county level. This commenter stated that they 
strongly believe that the wage index for any county or service area 
should not decrease by more than five percent in any given year and 
expressed support for the proposal that each Transitional CBSA, in 
which the included county(s) would have any reduction to their wage 
index limited to five percent from the previous year, should remain 
active until such time that the county(s) included would be able to be 
included in their new CBSA/Service Area when the reduction to their 
Wage Index would be five percent or less.
    This commenter also recommended that CMS provide a crosswalk in CSV 
or Excel format of any/all changes any year in which there are changes 
such as these, stating that the crosswalk should include the Social 
Security Administration (SSA) Code, FIPS Code, CBSA Code (and 
transition code where applicable), and the Wage Index (and transition 
wage index where applicable) for every unique County or Service Area 
covered under the Medicare program. Another commenter requested that 
CMS carefully plan communication to impacted facilities so that they 
are clear regarding what number to use on home health claims.
    Response: We thank the commenters for their support. We acknowledge 
the importance of providing an accurate crosswalk for the CY 2025 wage 
index that highlights the changes due to the revised OMB delineations, 
specifically in counties that will require a transition code. 
Therefore, we are listing the counties that will require a transition 
code in CY 2025 in table 19 and we are also including this table in the 
CY 2025 wage index file. The CY 2025 wage index file provides a 
crosswalk between the current OMB delineations and the final revised 
OMB delineations that will be in effect in CY 2025. This file shows 
each state and county and its corresponding final wage index along with 
the previous CBSA number, the final CBSA number or alternate 
identification number, and the final CBSA name. The list of counties 
that will require a transition code beginning in CY 2025 will also be 
included in the CY 2025 Home Health Rate Update Change Request that can 
be located at https://www.cms.gov/medicare/regulations-guidance/transmittals.
    Final Decision: We are finalizing our proposal to adopt the revised 
OMB delineations from OMB Bulletin 23-01, and will also apply the 
permanent 5-percent cap on wage index decreases at the county level 
with the use of a transition code, so that counties impacted by the 
revised designations will receive a 5-percent cap on any decrease in a 
geographic area's wage index value from the wage index value from the 
prior calendar year for CY 2025. We are also finalizing our proposal 
that, beginning in CY 2025, counties that have a different wage index 
value than the CBSA or rural area into which they are designated due to 
the application of the 5-percent cap (including redesignated counties 
that will receive the 5-percent cap and redesignated counties that move 
into a CBSA or rural area where all other constituent counties receive 
the 5-percent cap) will use a wage index transition code. These special 
codes are five digits in length and begin with ``50.'' The 50XXX wage 
index transition codes will be used only in specific counties; counties 
located in CBSAs and rural areas that do not correspond to a different 
transition wage index value will still use the CBSA number. Finally, we 
are finalizing the policy that the 5-percent cap will apply to a county 
that corresponds to a different wage index value than the wage index 
value in the CBSA or rural area in which they are designated due to a 
delineation change until the county's new wage index is more than 95 
percent of the wage index from the previous calendar year. In order to 
capture the correct wage index value, the county will continue to use 
the assigned 50XXX transition code until the county's wage index value 
calculated for that fiscal year using the new OMB delineations is not 
less than 95 percent of the county's capped wage index from the 
previous calendar year.
    The final wage index file applicable to CY 2025 provides a 
crosswalk between the CY 2025 wage index using the current OMB 
delineations and the CY 2025 wage index using the revised OMB 
delineations that will be in effect in CY 2025. This file shows each 
state and county and its corresponding final wage index along with the 
previous CBSA number, the final CBSA number or transition code, and the 
finalized CBSA name. The final HH PPS wage index file applicable for CY 
2025 (January 1, 2025, through December 31, 2025) is available on the 
CMS website at https://www.cms.gov/medicare/enrollment-

[[Page 88422]]

renewal/providers-suppliers/home-health-agency-center.
3. Final CY 2025 Home Health Wage Index
    Sections 1895(b)(4)(A)(ii) and (b)(4)(C) of the Act require the 
Secretary to provide appropriate adjustments to the proportion of the 
payment amount under the HH PPS that account for area wage differences, 
using adjustment factors that reflect the relative level of wages and 
wage-related costs applicable to the furnishing of home health 
services. Since the inception of the HH PPS, we have used inpatient 
hospital wage data in developing a wage index to be applied to home 
health payments. We proposed to continue this practice for CY 2025, as 
it is our belief that, in the absence of home health-specific wage data 
that accounts for area differences, using inpatient hospital wage data, 
including any changes made by the Office of Management and Budget (OMB) 
to Metropolitan Statistical Area (MSA) definitions, is appropriate and 
reasonable for the HH PPS. The appropriate wage index value is applied 
to the labor portion of the HH PPS rates based on the site of service 
for the beneficiary (defined by section 1861(m) of the Act as the 
beneficiary's place of residence).
    For CY 2025, we proposed to base the HH PPS wage index on the FY 
2025 hospital pre-floor, pre-reclassified wage index for hospital cost 
reporting periods beginning on or after October 1, 2020, and before 
October 1, 2021 (FY 2021 cost report data), with the revised OMB 
delineations. The final CY 2025 HH PPS wage index will not take into 
account any geographic reclassification of hospitals, including those 
in accordance with section 1886(d)(8)(B) or 1886(d)(10) of the Act but 
will include the 5-percent cap on wage index decreases.
    There exist some geographic areas where there are no hospitals, and 
thus, no hospital wage data on which to base the calculation of the HH 
PPS wage index. To address those geographic areas in which there are no 
inpatient hospitals, and thus, no hospital wage data on which to base 
the calculation of the CY 2025 HH PPS wage index, we proposed to 
continue to use the same methodology discussed in the CY 2007 HH PPS 
final rule (71 FR 65884) to address those geographic areas in which 
there are no inpatient hospitals.
    For urban areas without inpatient hospitals, we use the average 
wage index of all urban areas within the State as a reasonable proxy 
for the wage index for that CBSA. For CY 2025, the only urban area 
without inpatient hospital wage data is Hinesville, GA (CBSA 25980). 
Using the average wage index of all urban areas in Georgia as a proxy, 
we proposed the CY 2025 wage index value for Hinesville, GA, would be 
0.8608. With updated data, the final wage index value for Hinesville, 
GA, will be 0.8824.
    For rural areas that do not have inpatient hospitals, we proposed 
to use the average wage index from all contiguous Core Based 
Statistical Areas (CBSAs) as a reasonable proxy. The term 
``contiguous'' means sharing a border (72 FR 49859). For CY 2025, as 
part of our proposal to adopt the revised OMB delineations discussed 
further in section III.E.2. of the CY 2025 HH PPS proposed rule, we 
proposed that rural North Dakota would now become a rural area without 
a hospital from which hospital wage data can be derived. Therefore, in 
order to calculate the wage index for rural area 99935, North Dakota, 
we proposed to use as a proxy, the average pre-floor, pre-reclassified 
hospital wage data from the contiguous CBSAs: CBSA 13900-Bismark, ND, 
CBSA 22020-Fargo, ND-MN, CBSA 24220-Grand Forks, ND-MN, and CBSA 33500, 
Minot, ND, which resulted in a proposed CY 2025 HH PPS wage index of 
0.8334 for rural North Dakota. For this final rule using updated data, 
the final wage index value for rural North Dakota will be 0.8503 which 
is the average pre-floor, pre-reclassified wage index values after the 
application of the 5-percent cap of the four contiguous counties 
outlined in table 20.
[GRAPHIC] [TIFF OMITTED] TR07NO24.049

    Previously, the only rural area without a hospital from which 
hospital wage data could be derived was in Puerto Rico. However, for 
rural Puerto Rico, we did not apply this methodology due to the 
distinct economic circumstances that exist there (for example, due to 
the proximity of one another of almost all of Puerto Rico's various 
urban and non-urban areas, this methodology will produce a wage index 
for rural Puerto Rico that is higher than that in half of its urban 
areas). Instead, we used the most recent wage index previously 
available for that area, which was 0.4047. For CY 2025, due to our 
proposal to adopt the revised OMB delineations discussed previously, 
there is now a hospital in rural Puerto Rico from which hospital wage 
data can be derived. Therefore, we proposed that the wage index for 
rural Puerto Rico would now be based on the hospital wage data for the 
area instead of the previously available wage index of 0.4047. The 
unadjusted CY 2025 proposed wage index for rural Puerto Rico was 
0.2520. However, because 0.2520 is more than a 5 percent decline in the 
CY 2024 wage index, the 5-percent cap will be applied. We proposed that 
the CY 2025 5-percent cap adjusted wage index for rural Puerto Rico 
would be set equal to 95 percent of the CY 2024 wage index, which 
resulted in a proposed wage index value of 0.3845. For this final rule, 
using updated data, the final unadjusted wage index value for rural 
Puerto Rico is 0.2510. However, because 0.2510 is more than a 5 percent 
decline in the CY 2024 wage index, the 5-percent cap will be applied. 
The final CY 2025 5-percent cap adjusted wage index for rural Puerto 
Rico will be set equal to 95 percent of

[[Page 88423]]

the CY 2024 wage index, which results in a final wage index value of 
0.3845.
    Finally, due to the proposal to adopt the revised OMB delineations, 
Delaware, which was previously an all-urban state, will now have one 
rural area with a hospital from which hospital wage data can be 
derived. As such, we proposed that the CY 2025 wage index for rural 
Delaware would be 1.0429. The final wage index for rural Delaware will 
be 1.0385.
    The following is a summary of the comments we received on the CY 
2025 HH PPS wage index and our responses:
    Comment: Most commenters expressed concern with the updates to the 
home health wage index. Several commenters were particularly opposed to 
the wage index updates in rural areas. A commenter stated that 
utilizing hospital wage data to determine the average labor costs for 
rural home health agencies does not adequately reflect the costs of 
recruiting and retaining employees in rural settings. Another commenter 
stated that the current method of adjusting labor costs using the 
hospital wage index does not accurately account for increased travel 
costs and lost productivity in serving rural areas. This commenter 
recommended that the hospital wage index be adjusted based on 
population density.
    Response: We appreciate commenters' concerns regarding the wage 
index values assigned to rural areas. As discussed in the CY 2022 HH 
PPS final rule (86 FR 62285), we do not believe that a population 
density adjustment is appropriate at this time. Rural HHAs continually 
cite the added cost of traveling from one patient to the next. However, 
urban HHAs cite the added costs associated with needed security 
measures and traffic congestion. The home health wage index values in 
rural areas are not necessarily lower than the home health wage index 
values in urban areas. The home health wage index reflects the wages 
that inpatient hospitals pay in their local geographic areas. We 
continue to believe that in the absence of home health specific data, 
the pre-floor, pre-reclassified hospital wage index is appropriate for 
the geographic adjustment of home health claims.
    Comment: Many commenters recommended far-reaching revisions and 
reforms to the HH PPS wage index methodology. MedPAC recommended 
repealing and replacing the existing HH PPS wage index and phasing in 
new wage index systems for hospitals and other types of providers that 
uses all-employer, occupation-level wage data with different occupation 
weights for the wage index of each provider type; reflects local area 
level differences in wages between and within metropolitan statistical 
areas and statewide rural areas; and smooths wage index differences 
across adjacent local areas. Other commenters recommended discontinuing 
the use of the pre-floor, pre-reclassified hospital wage index as the 
basis for the HH PPS wage index and the creation of a home health 
specific wage index. Several commenters recommended allowing hospital 
provisions such as the area wage index policy that addresses the 
disparity in payments between rural and urban acute care hospitals, 
geographic reclassification, and an outmigration adjustment in the HH 
PPS wage index. Other commenters recommended that CMS institute a floor 
policy in the HH PPS. A few commenters recommended that CMS institute a 
rural floor in the HH PPS like the rural floor provided to hospitals. A 
few commenters recommended a 0.8000 floor in the HH PPS wage index 
similar to the hospice floor, while other commenters located in Puerto 
Rico recommended a floor of 0.6000 in the HH PPS.
    Response: We thank the commenters for their recommendations. 
However, any updates to the home health wage index outside the proposed 
policies are outside the scope of the proposed rule. Changes to the HH 
PPS wage index would need to go through notice and comment rulemaking. 
Furthermore, we continue to believe that the regulations and statutes 
that govern the HH PPS differ from the hospital and hospice regulations 
and statutes, such that there would be differences between how these 
payment systems apply wage index policies including geographic 
reclassification, outmigration or the rural floor. Section 4410(a) of 
the Balanced Budget Act of 1997 provides that the area wage index 
applicable to any hospital that is located in an urban area of a state 
may not be less than the area wage index applicable to hospitals 
located in rural areas in that State. This rural floor provision is 
specific to hospitals. The reclassification provision at section 
1886(d)(10)(C)(i) of the Act states that the Medicare Geographic 
Classification Review Board shall consider the application of any 
subsection (d) hospital requesting the Secretary change the hospital's 
geographic classification for purposes of payment under the IPPS. This 
reclassification provision is only applicable to hospitals as defined 
in section 1886(d) of the Act. In addition, we do not believe that 
using hospital reclassification data would be appropriate as these data 
are specific to the requesting hospitals.
    Additionally, the application of the hospice floor is specific to 
hospices and does not apply to HHAs. The hospice floor was developed 
through a negotiated rulemaking advisory committee, under the process 
established by the Negotiated Rulemaking Act of 1990 (Pub. L. 101-648). 
Committee members included representatives of national hospice 
associations; rural, urban, large, and small hospices; multi-site 
hospices; consumer groups; and a government representative. The 
Committee reached consensus on a methodology that resulted in the 
hospice wage index. We continue to believe the use of the pre-floor and 
pre- reclassified hospital wage index results in the most appropriate 
adjustment to the labor portion of the home health payment rates.
    Final decision: After consideration of public comments, we are 
finalizing our proposal to use the FY 2025 pre-floor, pre-reclassified 
hospital wage index as the basis for the CY 2025 HH PPS wage index. The 
complete final CY 2025 wage index is available on the CMS website at 
https://www.cms.gov/Center/Provider-Type/Home-Health-Agency-HHA-Center.
4. CY 2025 Home Health Payment Update
a. Background
    The HH PPS has been in effect since October 1, 2000. As set forth 
in the July 3, 2000, final rule (65 FR 41128), the base unit of payment 
under the HH PPS was a national, standardized 60-day episode payment 
rate. As finalized in the CY 2019 HH PPS final rule with comment period 
(83 FR 56406), and as described in the CY 2020 HH PPS final rule with 
comment period (84 FR 60478), the unit of home health payment changed 
from a 60-day episode to a 30-day period effective for those 30-day 
periods beginning on or after January 1, 2020.
    As set forth in Sec.  484.220, we adjust the national, standardized 
prospective payment rates by a case-mix relative weight and a wage 
index value based on the site of service for the beneficiary. To 
provide appropriate adjustments to the proportion of the payment amount 
under the HH PPS to account for area wage differences, we apply the 
appropriate wage index value to the labor portion of the HH PPS rates. 
In the CY 2024 HH PPS final rule (88 FR 77676), we finalized the 
rebasing of the home health market basket to reflect 2021 Medicare cost 
report data. We also finalized that for CY 2024 and

[[Page 88424]]

subsequent years the labor-related share will be 74.9 percent and the 
non-labor-related share will be 25.1 percent. The following are the 
steps we take to compute the case-mix and wage-adjusted 30-day period 
payment amount for CY 2025:
     Multiply the national, standardized 30-day period rate by 
the patient's applicable case-mix weight.
     Divide the case-mix adjusted amount into a labor (74.9 
percent) and a non-labor portion (25.1 percent).
     Multiply the labor portion by the applicable wage index 
based on the site of service of the beneficiary.
     Add the wage-adjusted portion to the non-labor portion, 
yielding the case-mix and wage adjusted 30-day period payment amount, 
subject to any additional applicable adjustments.
    We provide annual updates of the HH PPS rate in accordance with 
section 1895(b)(3)(B) of the Act. Section 484.225 sets forth the 
specific annual percentage update methodology. In accordance with 
section 1895(b)(3)(B)(v) of the Act and Sec.  484.225(i), for an HHA 
that does not submit home health quality data, as specified by the 
Secretary, the unadjusted national prospective 30-day period rate is 
equal to the rate for the previous calendar year increased by the 
applicable home health payment update percentage, minus two percentage 
points. Any reduction of the percentage change will apply only to the 
calendar year involved and will not be considered in computing the 
prospective payment amount for a subsequent calendar year.
    The final claim that the HHA submits for payment determines the 
total payment amount for the period and whether we make an applicable 
adjustment to the 30-day case-mix and wage-adjusted payment amount. The 
end date of the 30-day period, as reported on the claim, determines 
which calendar year rates Medicare will use to pay the claim.
    We may adjust a 30-day case-mix and wage-adjusted payment based on 
the information submitted on the claim to reflect the following:
     A LUPA is provided on a per-visit basis as set forth in 
Sec. Sec.  484.205(d)(1) and 484.230.
     A partial payment adjustment as set forth in Sec. Sec.  
484.205(d)(2) and 484.235.
     An outlier payment as set forth in Sec. Sec.  
484.205(d)(3) and 484.240.
b. CY 2025 National, Standardized 30-Day Period Payment Amount
    Section 1895(b)(3)(A)(i) of the Act requires that the standard 
prospective payment rate and other applicable amounts be standardized 
in a manner that eliminates the effects of variations in relative case-
mix and area wage adjustments among different home health agencies in a 
budget-neutral manner. To determine the CY 2025 national, standardized 
30-day period payment rate, we will continue our practice of using the 
most recent, complete utilization data at the time of rulemaking; that 
is, we are using CY 2023 claims data for CY 2025 payment rate updates. 
We apply a permanent adjustment factor, a case-mix weights 
recalibration budget neutrality factor, a wage index budget neutrality 
factor, and the home health payment update percentage to update the CY 
2025 payment rate. As discussed in section II.C.1. of this final rule, 
we are finalizing the implementation of a permanent adjustment of -
1.975 percent to ensure that payments under the PDGM do not exceed what 
payments would have been under the 153-group payment system as required 
by law. The final permanent adjustment factor is 0.98025. As discussed 
previously, to ensure the changes to the PDGM case-mix weights are 
implemented in a budget neutral manner, we apply a case-mix weight 
budget neutrality factor to the CY 2025 national, standardized 30-day 
period payment rate. The final case-mix weight budget neutrality factor 
for CY 2025 is 1.0039.
    Additionally, we apply a wage index budget neutrality factor to 
ensure that wage index updates and revisions are implemented in a 
budget neutral manner. To calculate the wage index budget neutrality 
factor, we first determine the payment rate needed for non-LUPA 30-day 
periods using the CY 2025 wage index (with the final revised 
delineations and the 5-percent cap) so those total payments are 
equivalent to the total payments for non-LUPA 30-day periods using the 
CY 2024 wage index (with the old delineations and the 5-percent cap) 
and the CY 2024 national standardized 30-day period payment rate 
adjusted by the case-mix weights recalibration neutrality factor. Then, 
by dividing the payment rate for non-LUPA 30-day periods using the CY 
2025 wage index (with the final revised delineations and a 5-percent 
cap on wage index decreases) by the payment rate for non-LUPA 30-day 
periods using the CY 2024 wage index (with the old delineations and a 
5-percent cap on wage index decreases), we obtain a wage index budget 
neutrality factor of 0.9988. We then apply the wage index budget 
neutrality factor of 0.9988 to the 30-day period payment rate.
    Next, we update the 30-day period payment rate by the final CY 2025 
home health payment update percentage of 2.7 percent. The CY 2025 
national standardized 30-day period payment rate is calculated in table 
21.
[GRAPHIC] [TIFF OMITTED] TR07NO24.050

    The CY 2025 national standardized 30-day period payment rate for an 
HHA that does not submit the required quality data is updated by the 
final CY 2025 home health payment update percentage of 0.7 percent (2.7 
percent minus 2 percentage points) and is shown in table 22.

[[Page 88425]]

[GRAPHIC] [TIFF OMITTED] TR07NO24.051

c. CY 2025 National Per-Visit Rates for 30-Day Periods of Care
    The national per-visit rates are used to pay LUPAs and are also 
used to compute imputed costs in outlier calculations. The per-visit 
rates are paid by type of visit or home health discipline. The six home 
health disciplines are as follows:
     Home health aide (HH aide).
     Medical Social Services (MSS).
     Occupational therapy (OT).
     Physical therapy (PT).
     Skilled nursing (SN).
     Speech-language pathology (SLP).
    To calculate the final CY 2025 national per-visit rates, we started 
with the CY 2024 national per-visit rates. Then we applied a wage index 
budget neutrality factor to ensure budget neutrality for LUPA per-visit 
payments. We calculated the wage index budget neutrality factor by 
simulating total payments for LUPA 30-day periods of care using the CY 
2025 wage index with the new delineations and the 5-percent cap on wage 
index decreases and comparing it to simulated total payments for LUPA 
30-day periods of care using the CY 2024 wage index with the old 
delineations and the 5-percent cap. By dividing the total payments for 
LUPA 30-day periods of care using the CY 2025 wage index by the total 
payments for LUPA 30-day periods of care using the CY 2024 wage index, 
we obtained a wage index budget neutrality factor of 0.9989. As a 
reminder, the wage index budget neutrality factors for the national, 
standardized 30-day period amount and the national LUPA per-visit rates 
are not equal because they are calculated differently. The wage index 
budget neutrality factor for the LUPA per-visit payments is calculated 
by simulating total payments for LUPA 30-day periods while the 30-day 
period budget neutrality factor is calculated by simulating payments 
for non- LUPA 30-day periods.
    The LUPA per-visit rates are not calculated using case-mix weights. 
Therefore, no case-mix weight budget neutrality factor is needed to 
ensure budget neutrality for LUPA payments. Additionally, we are not 
applying the permanent adjustment to the per visit payment rates but 
only to the case-mix adjusted 30-day payment rate. Lastly, the per-
visit rates for each discipline are updated by the final CY 2025 home 
health payment update percentage of 2.7 percent. The national per-visit 
rates are adjusted by the wage index based on the site of service of 
the beneficiary. The per-visit payments for LUPAs are separate from the 
LUPA add-on payment amount, which is paid for periods that occur as the 
only period or initial period in a sequence of adjacent periods. The CY 
2025 national per-visit rates for HHAs that submit the required quality 
data are updated by the final CY 2025 home health payment update 
percentage of 2.7 percent and are shown in table 23.
[GRAPHIC] [TIFF OMITTED] TR07NO24.052

    The CY 2025 per-visit payment rates for HHAs that do not submit the 
required quality data are updated by the final CY 2025 home health 
payment update percentage of 2.7 percent minus 2 percentage points and 
are shown in table 24.

[[Page 88426]]

[GRAPHIC] [TIFF OMITTED] TR07NO24.053

    We did not receive any comments on the CY 2025 30-day home health 
payment rates or the per-visit payment rates.
    Final Decision: We are finalizing the updates to the CY 2025 
national, standardized 30-day period payment rates and the CY 2025 
national per-visit payment amounts as proposed, using the updated 
market basket amount.
d. LUPA Add-On Factors
    As outlined in the CY 2025 HH PPS proposed rule, prior to the 
implementation of the 30-day unit of payment, LUPA episodes were 
eligible for a LUPA add-on payment if the episode of care was the first 
or only episode in a sequence of adjacent episodes. As described in the 
CY 2008 HH PPS final rule, the average visit lengths in these initial 
LUPAs are 16 to 18 percent higher than the average visit lengths in 
initial non-LUPA episodes (72 FR 49848). LUPA episodes that occur as 
the only episode or as an initial episode in a sequence of adjacent 
episodes are adjusted by applying an additional amount to the LUPA 
payment before adjusting for area wage differences.
    In the CY 2014 HH PPS final rule (78 FR 72305), we changed the 
methodology for calculating the LUPA add-on amount, whereby we 
finalized the approach of multiplying the per-visit payment amount for 
the first skilled nursing (SN), physical therapy (PT), or speech 
language pathology (SLP) visit in LUPA episodes that occur as the only 
episode or an initial episode in a sequence of adjacent episodes by 1 + 
the proportional increase in minutes for an initial visit over non-
initial visits. Specifically, we updated the analysis using 100 percent 
of LUPA episodes and a 20 percent sample of non-LUPA first episodes 
from CY 2012 claims data. At that time, we finalized add on factors: 
1.8451 for SN; 1.6700 for PT; and 1.6266 for SLP. In the CY 2019 HH PPS 
final rule with comment period (83 FR 56440), in addition to finalizing 
a 30-day unit of payment, we finalized our policy of continuing to 
multiply the per-visit payment amount for the first SN, PT, or SLP 
visit in LUPA periods that occur as the only period of care or the 
initial 30-day period of care in a sequence of adjacent 30-day periods 
of care by the appropriate add-on factor (using the already established 
LUPA add-on factors of 1.8451 for SN, 1.6700 for PT, and 1.6266 for 
SLP) to determine the LUPA add-on payment amount for 30-day periods of 
care under the PDGM.
    In an effort to enhance the accuracy and relevance of LUPA add-on 
factors to reflect current healthcare practices and costs, we proposed 
updates to the LUPA add-on factors for PT, SN, and SLP, which have not 
been revised since the CY 2014 HH PPS final rule, during which CY 2012 
data was used. We proposed to use the same methodology (as specified in 
the CY 2025 HH PPS proposed rule) used to establish the LUPA add-on 
amount for CY 2014, using updated claims data.
    Specifically, we proposed to update the LUPA add-on factors by 
using 100 percent of LUPA periods and a 100 percent sample of non-LUPA 
first periods from CY 2023 claims data. In the CY 2025 HH PPS proposed 
rule (89 FR 55377), using the CY 2023 data available at that time, the 
proposed updates to the factors were 1.7227 for SN; 1.6247 for PT; and 
1.6703 for SLP. We stated that the proposed LUPA add-on factors will be 
updated based on more complete CY 2023 claims data in the final rule. 
The updated analysis (as of September 11, 2024) demonstrates that the 
average excess of minutes for the first visit in LUPA periods that were 
the only period or an initial LUPA in a sequence of adjacent periods 
are 29.91 minutes for the first visit if SN, 28.08 minutes for the 
first visit if PT, and 31.57 minutes for the first visit if SLP. The 
average minutes for all non-first visits in non-LUPA episodes are 41.54 
minutes for SN, 45.11 minutes for PT, and 47.15 minutes for SLP. To 
determine the LUPA add-on factors for each discipline in relation to 
the final LUPA add-on factor updates, we calculate the ratio of the 
average excess minutes for the first visits in LUPA claims to the 
average minutes for all non-first visits in non-LUPA claims. We then 
add one to these ratios to obtain the final add on factors: 1.7200 for 
SN; 1.6225 for PT; and 1.6696 for SLP. We solicited comments on the 
proposals to update the LUPA factors using the CY 2014 methodology and 
the re-priced LUPA payment amounts. A summary of these comments and our 
responses are as follows:
    Comment: All commenters expressed support for updates to the LUPA 
add-on factors for skilled nursing, physical therapy and speech 
language pathology using CY 2023 utilization data using the CY 2014 HH 
PPS methodology. Specifically, commenters expressed appreciation that 
CMS still recognizes LUPA per visit payments.
    Response: We thank the commenters for their support.
    Comment: A commenter expressed support for CMS' efforts to adjust 
the LUPA add-on factor but noted that the adjustments remain minimal 
and are not

[[Page 88427]]

adequately aligned with inflationary trends.
    Response: We thank the commenter for their comment. The LUPA add-on 
factors were adjusted in a budget neutral manner, as statutorily 
required in section 1895(b)(3)(A)(i) of the Act, so that aggregate 
payments do not increase or decrease.
    Final Decision: We are finalizing the proposal to update the SN, 
PT, and SLP LUPA add-on factors. The final LUPA add-on factors are 
1.7200 for skilled nursing, 1.6225 for physical therapy, and 1.6696 for 
speech-language pathology.
e. Occupational Therapy LUPA Add-On Factor
    As outlined in the CY 2025 HH PPS proposed rule, in order to 
implement Division CC, section 115, of the Consolidation Appropriations 
Act (CAA), 2021, CMS finalized changes to the regulations at Sec.  
484.55(a)(2) and (b)(3) that allowed occupational therapists to conduct 
initial and comprehensive assessments for all Medicare beneficiaries 
under the home health benefit when the plan of care does not initially 
include skilled nursing care, but included OT, as well as either PT or 
SLP (86 FR 62351). This change necessitated the establishment of a LUPA 
add-on factor for calculating the LUPA add-on payment amount for the 
first skilled OT visit in LUPA periods that occurs as the only period 
of care or the initial 30-day period of care in a sequence of adjacent 
30-day periods of care. However, at the time of the implementation, as 
we stated in the CY 2022 HH PPS final rule (86 FR 62289), there was not 
sufficient data regarding the average excess of minutes for the first 
visit in LUPA periods when the initial and comprehensive assessments 
are conducted by occupational therapists. Therefore, we finalized a 
policy using the PT LUPA add-on factor as a proxy. We also stated in 
the CY 2022 final rule that we will use the PT LUPA add-on factor as a 
proxy until we have CY 2022 data to establish a more accurate OT add-on 
factor for the LUPA add-on payment amounts (86 FR 62289). Ultimately, 
we refrained from using CY 2022 data (and instead utilized the PT LUPA 
add-on factor as a proxy for the OT LUPA add-on factor), as we marked 
the first year that occupational therapists were permitted to conduct 
the initial assessment. Therefore, we wanted to extend our analysis to 
ensure we had sufficient data to reflect OT time spent conducting 
initial assessments to establish a discrete OT LUPA add-on factor (86 
FR 62240). Accordingly, we continued analyzing claims data and have 
opted to utilize CY 2023 data to make the proposal.
    With sufficient recent claims data available, and to establish 
equitable compensation for all home health services, CMS proposed to 
establish a definitive OT-specific LUPA add-on factor and discontinue 
the temporary use of the PT LUPA add-on factor as a proxy. For the 
proposal, we used the same methodology used to establish the LUPA add-
on amount for CY 2014, as also described previously for the SN, PT and 
SLP add-on factors. Specifically, we updated the analysis using 100 
percent of LUPA periods and a 100 percent sample of non-LUPA first 
periods from CY 2023 claims data. The originally proposed analysis 
showed that the average excess of minutes for the first OT visit in 
LUPA periods that were the only period or an initial LUPA in a sequence 
of adjacent periods as 33.40 minutes for the first visit and the 
average number of minutes for all non-first visits in non-LUPA periods 
as 45.97 minutes for OT. However, the proposal was made using the most 
current and complete data available at the time of rulemaking. We 
stated that we believe that LUPA add-on factors will be updated based 
on more complete CY 2023 claims data in the final rule. In doing so, 
the updated analysis (as of September 11, 2024) shows that the average 
excess of minutes for the first OT visit in LUPA periods that were the 
only period or an initial LUPA in a sequence of adjacent periods is 
33.28 minutes for the first visit. The average number of minutes for 
all non-first visits in non-LUPA periods is 45.98 minutes for OT.
    To determine the LUPA add-on factors for OT to adequately adjust 
LUPA payments to account for the excess minutes during the first visit 
in a LUPA period, we proposed to calculate the ratio of the average 
excess minutes for the first visits in LUPA claims to the average 
minutes for all non-first visits in non-LUPA claims. We proposed to 
then add one to this ratio to obtain the proposed add on factor: 1.7238 
for OT.
    The following table 25 shows, for all disciplines, the average 
excess minutes for the first visit in LUPA periods, the average minutes 
for all non-first visits in non-LUPA episodes, as well as the current 
LUPA add-on factors, the final LUPA add-on factors (using updated CY 
2023 claims data), and the percent change between the current and the 
final LUPA add-on factors.
[GRAPHIC] [TIFF OMITTED] TR07NO24.054

    We solicited comments on the proposed establishment of a definitive 
OT LUPA add-on factor, use of CY 2023 data to determine the OT LUPA 
add-on factor, as well as the proposed methodology to determine this OT 
LUPA add-on factor. A summary of these comments and our responses are 
as follows:
    Comment: All commenters expressed support for establishment of the 
definitive LUPA add-on factor for occupational therapy using CY 2023 
utilization data and the CY 2014 HH PPS methodology.
    Response: We thank the commenters for their support.
    Comment: A commenter expressed appreciation for CMS' recognition of 
the unique needs of OT services through the

[[Page 88428]]

establishment of a distinct OT LUPA add-on factor. However, they voiced 
concern that the current add-on factor does not fully address the 
challenges faced by occupational therapists, particularly in light of 
payment rate reductions. As such, the commenter recommended that CMS 
continuously evaluate and adjust the OT add-on factor.
    Response: We thank the commenter for their comment. However, the 
payment rate adjustment was made to the 30-day base payment rate and 
the OT LUPA add-on factor was established in a budget neutral manner, 
as statutorily required in section 1895(b)(3)(A)(i) of the Act. We will 
update the LUPA add-on factors as necessary in accordance with 
applicable regulations.
    Comment: Many commenters raised concerns regarding proposed payment 
rate reductions specific to occupational therapy services, specifically 
stating that proposed payment cuts to occupational therapy could 
significantly reduce access to essential occupational therapy services 
for Medicare beneficiaries receiving care at home.
    Response: We appreciate the commenters' concern. It appears that 
many commenters conflated the OT LUPA add-on factor proposal with the 
proposed permanent adjustment to the national, standardized 30-day 
payment rate. To clarify, in the CY 2025 HH PPS proposed rule (89 FR 
55377) we did not propose any OT-specific payment rate cuts. In fact, 
with the proposal to establish a definitive OT LUPA add-on factor and 
discontinue the use of the PT LUPA add-on factor as a proxy, the add-on 
factor for OT services has increased by 3.2 percent.
    Final Decision: We are finalizing the proposal to discontinue use 
of the PT LUPA add-on factor as a proxy and establish the definitive 
LUPA add-on factor for occupational therapy to be used in calculating 
the LUPA add-on payment amounts. The OT LUPA factor is 1.7238 when 
occupational therapy is the first skilled visit in a LUPA period that 
occurs as the only period or an initial period in a sequence of 
adjacent periods.
f. Payments for High-Cost Outliers Under the HH PPS
(1) Background
    Section 1895(b)(5) of the Act allows for the provision of an 
addition or adjustment to the home health payment amount otherwise made 
in the case of outliers because of unusual variations in the type or 
amount of medically necessary care. Under the HH PPS and the previous 
unit of payment (that is, 60-day episodes), outlier payments were made 
for 60-day episodes whose estimated costs exceed a threshold amount for 
each HHRG. The episode's estimated cost was established as the sum of 
the national wage-adjusted per visit payment amounts delivered during 
the episode. The outlier threshold for each case-mix group or PEP 
adjustment defined as the 60-day episode payment or PEP adjustment for 
that group plus a fixed-dollar loss (FDL) amount. For the purposes of 
the HH PPS, the FDL amount is calculated by multiplying the home health 
FDL ratio by a case's wage-adjusted national, standardized 60-day 
episode payment rate, which yields an FDL dollar amount for the case. 
The outlier threshold amount is the sum of the wage and case-mix 
adjusted PPS episode amount and wage-adjusted FDL amount. The outlier 
payment is defined to be a proportion of the wage-adjusted estimated 
cost that surpasses the wage-adjusted threshold. The proportion of 
additional costs over the outlier threshold amount paid as outlier 
payments is referred to as the loss-sharing ratio.
    As we noted in the CY 2011 HH PPS final rule (75 FR 70397 through 
70399), section 3131(b)(1) of the Affordable Care Act amended section 
1895(b)(3)(C) of the Act to require that the Secretary reduce the HH 
PPS payment rates such that aggregate HH PPS payments were reduced by 5 
percent. In addition, section 3131(b)(2) of the Affordable Care Act 
amended section 1895(b)(5) of the Act by redesignating the existing 
language as section 1895(b)(5)(A) of the Act and revised the language 
to state that the total amount of the additional payments or payment 
adjustments for outlier episodes could not exceed 2.5 percent of the 
estimated total HH PPS payments for that year. Section 3131(b)(2)(C) of 
the Affordable Care Act also added section 1895(b)(5)(B) of the Act, 
which capped outlier payments as a percent of total payments for each 
HHA for each year at 10 percent.
    As such, beginning in CY 2011, we reduced payment rates by 5 
percent and targeted up to 2.5 percent of total estimated HH PPS 
payments to be paid as outliers. To do so, we first returned the 2.5 
percent held for the target CY 2010 outlier pool to the national, 
standardized 60-day episode rates, the national per visit rates, the 
LUPA add-on payment amount, and the NRS conversion factor for CY 2010. 
We then reduced the rates by 5 percent as required by section 
1895(b)(3)(C) of the Act, as amended by section 3131(b)(1) of the 
Affordable Care Act. For CY 2011 and subsequent calendar years we 
targeted up to 2.5 percent of estimated total payments to be paid as 
outlier payments, and apply a 10-percent agency-level outlier cap.
    In the CY 2017 HH PPS proposed and final rules (81 FR 43737 through 
43742 and 81 FR 76702), we described our concerns regarding patterns 
observed in home health outlier episodes. Specifically, we noted the 
methodology for calculating home health outlier payments may have 
created a financial incentive for providers to increase the number of 
visits during an episode of care in order to surpass the outlier 
threshold; and simultaneously created a disincentive for providers to 
treat medically complex beneficiaries who require fewer but longer 
visits. Given these concerns, in the CY 2017 HH PPS final rule (81 FR 
76702), we finalized changes to the methodology used to calculate 
outlier payments, using a cost-per-unit approach rather than a cost-
per-visit approach. This change in methodology allows for more accurate 
payment for outlier episodes, accounting for both the number of visits 
during an episode of care and the length of the visits provided. Using 
this approach, we now convert the national per-visit rates into per 15-
minute unit rates. These per 15-minute unit rates are used to calculate 
the estimated cost of an episode to determine whether the claim will 
receive an outlier payment and the amount of payment for an episode of 
care. In conjunction with our finalized policy to change to a cost-per-
unit approach to estimate episode costs and determine whether an 
outlier episode should receive outlier payments, in the CY 2017 HH PPS 
final rule we also finalized the implementation of a cap on the amount 
of time per day that will be counted toward the estimation of an 
episode's costs for outlier calculation purposes (81 FR 76725). 
Specifically, we limit the amount of time per day (summed across the 
six disciplines of care) to 8 hours (32 units) per day when estimating 
the cost of an episode for outlier calculation purposes.
    In the CY 2017 HH PPS final rule (81 FR 76724), we stated that we 
did not plan to re-estimate the average minutes per visit by discipline 
every year. Additionally, the per unit rates used to estimate an 
episode's cost were updated by the home health update percentage each 
year, meaning we will start with the national per visit amounts for the 
same calendar year when calculating the cost-per-unit used to determine 
the cost of an episode of care (81 FR 76727). We will continue to 
monitor the visit length by discipline as more recent data

[[Page 88429]]

becomes available and may propose to update the rates as needed in the 
future.
    In the CY 2019 HH PPS final rule with comment period (83 FR 56521), 
we finalized a policy to maintain the current methodology for payment 
of high-cost outliers upon implementation of PDGM beginning in CY 2020 
and calculated payment for high-cost outliers based upon 30-day period 
of care. Upon implementation of the PDGM and 30-day unit of payment, we 
finalized the FDL ratio of 0.56 for 30-day periods of care in CY 2020. 
Given that CY 2020 was the first year of the PDGM and the change to a 
30-day unit of payment, we finalized maintaining the same FDL ratio of 
0.56 in CY 2021 as we did not have sufficient CY 2020 data at the time 
of CY 2021 rulemaking to propose a change to the FDL ratio for CY 2021. 
In the CY 2022 HH PPS final rule with comment period (86 FR 62292), we 
estimated that outlier payments will be approximately 1.8 percent of 
total HH PPS final rule payments if we maintained an FDL of 0.56 in CY 
2022. Therefore, in order to pay up to, but no more than, 2.5 percent 
of total payments as outlier payments we finalized an FDL of 0.40 for 
CY 2022. In the CY 2023 HH PPS final rule (87 FR 66875), using CY 2021 
claims utilization data, we finalized an FDL of 0.35 in order to pay up 
to, but no more than, 2.5 percent of the total payment as outlier 
payments in CY 2023. In the CY 2024 HH PPS final rule (88 FR 77749), 
using CY 2022 claims utilization data, we finalized an FDL of 0.27 for 
CY 2024.
(2) FDL Ratio for CY 2025
    For a given level of outlier payments, there is a trade-off between 
the values selected for the FDL ratio and the loss-sharing ratio. A 
high FDL ratio reduces the number of periods that can receive outlier 
payments but makes it possible to select a higher loss-sharing ratio, 
and therefore, increase outlier payments for qualifying outlier 
periods. Alternatively, a lower FDL ratio means that more periods can 
qualify for outlier payments, but outlier payments per period must be 
lower.
    The FDL ratio and the loss-sharing ratio are selected so that the 
estimated total outlier payments do not exceed the 2.5 percent 
aggregate level (as required by section 1895(b)(5)(A) of the Act). 
Historically, we have used a value of 0.80 for the loss-sharing ratio, 
which, we believe, preserves incentives for agencies to attempt to 
provide care efficiently for outlier cases. With a loss-sharing ratio 
of 0.80, Medicare pays 80 percent of the additional estimated costs 
that exceed the outlier threshold amount. Using CY 2023 claims data (as 
of March 19, 2024) and given the statutory requirement that total 
outlier payments do not exceed 2.5 percent of the total payments 
estimated to be made under the HH PPS, we proposed an FDL ratio of 0.38 
for CY 2025 which is higher than the finalized CY 2024 FDL of 0.27. We 
stated that we would update the FDL, if needed, in the final rule once 
we have more complete CY 2023 claims data. Therefore, using updated CY 
2023 claims data as of (July 11, 2024) the final FDL ratio for CY 2025 
is 0.35.
    A summary of the comments we received on the proposed FDL ratio 
appears as follows.
    Comment: A commenter opposed the estimated 0.6 percent decrease to 
home health payments which is the result of increasing the fixed-dollar 
loss ratio for outlier payments in CY 2025. The commenter stated that 
that the 0.6 percent decrease should be eliminated as there is not 
adequate data to surmise that the cut is justified.
    Response: We thank the commenter for their comment. However, we 
disagree with the claim that there is not adequate data to justify the 
0.6 percent decrease. We are statutorily required to ensure that total 
outlier payments do not exceed the 2.5 percent aggregate level (as 
required by section 1895(b)(5)(A) of the Act). In the CY 2019 HH PPS 
final rule with comment period (83 FR 56521), we finalized a policy to 
maintain the current methodology for payment of high-cost outliers upon 
implementation of the PDGM beginning in CY 2020 and calculated payment 
for high-cost outliers based upon 30-day periods of care. We have used 
the most recent claims data to calculate the FDL ratio since that time. 
In the CY 2025 HH PPS proposed rule, we stated that we would use the 
most recent claims data available which is CY 2023 claims data. Using 
CY 2023 claims data, we found that the FDL ratio would need to be 
increased from the final CY 2024 FDL of 0.27 to the proposed CY 2025 
ratio of 0.38. A higher FDL ratio reduces the number of periods that 
can receive outlier payments, and as a result there is a slight 
decrease to total payments. Based on more complete CY 2023 claims data 
as of (July 11, 2024) the final CY 2025 FDL ratio has been adjusted to 
0.35 which results in a 0.4 percent decrease in total payments.
    Final Decision: We are finalizing the CY 2025 FDL ratio of 0.35, 
using updated CY 2023 claims data as of July 11, 2024.

F. Annual Rate Update for Disposable Negative Pressure Wound Therapy 
(dNPWT) Device

1. Background
    Negative pressure wound therapy (NPWT) is a medical procedure in 
which a vacuum dressing is used to enhance and promote healing in 
acute, chronic, and burn wounds. The therapy involves using a sealed 
wound dressing attached to a pump to create a negative pressure 
environment in the wound. The therapy can be administered using the 
conventional NPWT system, classified as durable medical equipment 
(DME), or can be administered using a disposable device. A disposable 
NPWT (dNPWT) device is a single-use integrated system that consists of 
a non-manual vacuum pump, a receptacle for collecting exudate, and 
wound dressings. Unlike conventional NPWT systems classified as DME, 
dNPWT devices have preset continuous negative pressure, no intermittent 
setting, are pocket-sized and easily transportable, and are generally 
battery-operated with disposable batteries. In order for a beneficiary 
to receive dNPWT under the home health benefit, the beneficiary must 
qualify for the home health benefit in accordance with existing 
eligibility requirements.
2. Payment Policies for dNPWT Devices
    Prior to CY 2024, the separate payment amount for dNPWT included 
the furnishing of services as well as the dNPWT device. The separate 
payment amount was set equal to the amount of the payment that will be 
made under the Medicare Hospital Outpatient Prospective Payment System 
(OPPS) using the CPT codes 97607 and 97608. Payment for visits where 
the sole purpose of a home health visit was to furnish dNPWT was not 
made under the HH PPS. Therefore, visits performed solely for the 
purpose of furnishing a new dNPWT device were not reported on the HH 
PPS claim (type of bill (TOB) 32x), instead HHAs submitted these claims 
on a TOB 34x. However, if a home health visit included the provision of 
other home health services in addition to, and separate from, 
furnishing dNPWT, the HHA submitted both a TOB 32x and TOB 34x--the TOB 
32x for other home health services and the TOB 34x for furnishing NPWT 
using a disposable device.
    Beginning in CY 2024, Division FF, section 4136 of the CAA, 2023 
(Pub. L. 117-328) amended section 1834 of the Act (42 U.S.C. 1395m(s)) 
and mandated several amendments to the Medicare separate payment for 
dNPWT. These changes included--

[[Page 88430]]

     For CY 2024, the separate payment amount for an applicable 
dNPWT device was set equal to the supply price used to determine the 
relative value for the service under the Physician Fee Schedule (PFS) 
under section 1848 as of January 1, 2022 (CY 2022), updated by the 
percent increase in the CPI-U for the 12-month period ending with June 
of the preceding year reduced by m the productivity adjustment 
described in section 1886(b)(3)(B)(xi)(II) of the Act for such year;
     For 2025 and each subsequent year, the separate payment 
amount was to be set equal to the payment amount established for the 
device in the previous year, updated by the percent increase in the 
CPI-U for the 12-month period ending with June of the preceding year 
reduced by the productivity adjustment described in section 
1886(b)(3)(B)(xi)(II) for such year.
     The separate payment amount for applicable devices 
furnished on or after January 1, 2024, will no longer include payment 
for nursing or therapy services described in section 1861(m) of the Act 
so that payment for such nursing or therapy services are now made under 
the HH PPS, and is no longer separately billable.
     Claims for the separate payment amount of an applicable 
dNPWT device are now accepted and processed on claims submitted using 
the type of bill (TOB) 32X.
    In the CY 2024 HH PPS final rule (88 FR 77676), we finalized our 
proposal to codify these changes to dNPWT payments mandated by the CAA, 
2023. Beginning January 1, 2024, the separate payment for a dNPWT 
device is made to an HHA for an individual who is under a home health 
plan of care using Healthcare Common Procedure Coding System (HCPCS) 
code A9272. The code HCPCS A9272 is defined as a wound suction, 
disposable, includes dressing, all accessories and components, any 
type, each. The HHA reports the HCPCS code A9272 for the device only on 
the home health TOB 32X. The services related to the application of the 
device are included in the home health payment and are excluded from 
the separate payment amount for the device. The CY 2024 single payment 
amount for a dNPWT device for individuals under a home health plan of 
care was set equal to $270.09, which equaled the supply price of an 
applicable device under the Medicare PFS (as of January 1, 2022) of 
$263.25 updated by the 2.6 percent increase in the CPI-U for the 12-
month period ending in June of 2023, minus the productivity adjustment.
3. CY 2025 Separate Payment Amount for a dNPWT Device
    For CY 2025, we proposed that the separate payment amount for a 
dNPWT device would be set equal to the CY 2024 payment amount of 
$270.09 updated by the CPI-U for June 2024, minus the productivity 
adjustment, as mandated by the CAA, 2023. The application of the 
productivity adjustment may result in a net update that may be less 
than 0.0 for a year and may result in the separate payment amount for 
an applicable device for a year being less than such separate payment 
amount for such device for the preceding year. We noted that the CPI-U 
for the 12-month period ending in June of 2024 was not available at the 
time of the proposed rulemaking and stated that the CY 2025 payment 
amount, as well as the CPI-U for the 12-month period ending in June of 
2024, and the corresponding productivity adjustment would be updated in 
the final rule.
    For this final rule, the CPI-U for the 12-month period ending in 
June of 2024 is 3.0 percent and the corresponding productivity 
adjustment is 0.6 percent based on IHS Global Inc.'s third-quarter 2024 
forecast of the CY 2025 productivity adjustment (which reflects the 10-
year moving average of changes in annual economy-wide private nonfarm 
business TFP for the period ending June 30, 2024) Therefore, the final 
update percentage will be 2.4 percent (3.0 percent reduced by 0.6 
percentage point). The final CY 2025 separate payment amount for a 
dNPWT device will be $276.57, which reflects the CY 2024 payment amount 
of $270.09 updated by the final update percentage of 2.4 percent.
[GRAPHIC] [TIFF OMITTED] TR07NO24.055

    The following is a summary of the public comments and our responses 
regarding the payment update for the dNPWT device.
    Comment: A commenter recommended that stakeholders be given the 
opportunity to comment on the final payment amount for dNPWT in the 
event there is an issue in the calculation of the rate.
    Response: We thank the commenter for their recommendation. However, 
we stated in the proposed rule that the CPI-U and productivity 
adjustment were not available in time for the publication of the 
proposed rule and the rate would be published in the final rule. 
Although the final rate was not available at the time of the proposed 
rule, in the CY 2025 HH PPS final rule (89 FR 77751), we finalized the 
policy of setting the separate payment of a dNPWT device equal to the 
payment amount established for the device in the previous year, updated 
by the percentage increase in the CPI-U reduced by the productivity 
adjustment for the 12-month period ending in June of the previous year. 
The CY 2025 final rule simply updates the dNPWT device separate payment 
amount using this finalized policy. As such, we believe there was 
adequate opportunity for commenters to provide feedback on the 
calculation of the final CY 2025 rate. If we are alerted to an issue in 
the calculation of this final rate after publication of this final 
rule, we would issue a correction notice if necessary.
    Comment: A commenter stated that while they recognize that changes 
to the dNPWT device separate payment amount were required by statute, 
they believe that the payment approach for dNPWT devices is confusing 
and adds another level of burden for HHAs. This commenter recommended 
that dNPWT be removed from the HH PPS payment structure entirely and be 
independently paid through the durable medical equipment (DME) benefit. 
The

[[Page 88431]]

commenter suggested that making this change would help ensure that 
Medicare beneficiaries receive appropriate wound care, and providers 
receive fair and equitable payment for supplies and related services.
    Response: We appreciate the commenter's recommendation. However, 
this comment is outside the scope of the proposed rule. We are 
statutorily required to process claims for the separate payment amount 
of an applicable dNPWT device on claims submitted using the type of 
bill (TOB) 32X, and the payment rate for dNPWT under the home health 
benefit is described in statute. Furthermore, dNPWT devices are 
disposable, thus would not be eligible for payment under the DME 
benefit. Therefore, the separate payment amount for dNPWT devices will 
continue to be reported on the home health TOB 32X using HCPCS code 
A9272 (for the device only). As a reminder, the services related to the 
application of the device are included in the home health payment and 
are excluded from the separate payment amount for the device.
    Final Decision: We are finalizing the CY 2025 separate payment 
amount for the dNPWT device under a home health plan of care of 
$276.57, which is equal to CY 2024 rate of $270.09 updated by the final 
update percentage of 2.4 percent. For CY 2026 and subsequent years, if 
CMS does not intend to propose changes to its established methodology 
for calculating dNPWT payments, payment rates will be updated using 
CMS's established methodology via the Home Health Prospective Payment 
System Rate Update Change Request and posted on the HHA Center website 
at https://www.cms.gov/medicare/enrollment-renewal/providers-suppliers/home-health-agency-center. For more in-depth information regarding the 
finalized policies associated with the scope of the payment for dNPWT 
and conditions for payment, we refer readers to the CY 2024 HH PPS 
final rule (88 FR 77749 through 77752).

III. Home Health Quality Reporting Program (HH QRP)

A. Background and Statutory Authority

    The HH QRP is authorized by section 1895(b)(3)(B)(v) of the Act. 
Section 1895(b)(3)(B)(v)(II) of the Act requires that, for 2007 and 
subsequent years, each home health agency (HHA) submit to the Secretary 
in a form and manner, and at a time, specified by the Secretary, such 
data that the Secretary determines are appropriate for the measurement 
of health care quality. To the extent that an HHA does not submit data 
in accordance with this clause, the Secretary shall reduce the home 
health market basket percentage increase applicable to the HHA for such 
year by 2 percentage points. As provided at section 1895(b)(3)(B)(vi) 
of the Act, depending on the market basket percentage increase 
applicable for a particular year, as further reduced by the 
productivity adjustment (except in 2018 and 2020) described in section 
1886(b)(3)(B)(xi)(II) of the Act, the reduction of that increase by 2 
percentage points for failure to comply with the requirements of the HH 
QRP may result in the home health market basket percentage increase 
being less than 0.0 percent for a year, and may result in payment rates 
under the Home Health PPS for a year being less than payment rates for 
the preceding year. Section 1890A of the Act requires that the 
Secretary establish and follow a pre-rulemaking process, in 
coordination with the consensus-based entity (CBE) with a contract 
under section 1890 of the Act, to solicit input from certain groups 
regarding the selection of quality and efficiency measures for the HH 
QRP. The HH QRP regulations can be found at 42 CFR 484.245 and 484.250.
    Based on feedback from patients and stakeholders, CMS has launched 
an effort to update and shorten the Home Health Consumer Assessment of 
Healthcare Providers and Systems (HHCAHPS) survey. In 2022, CMS tested 
a shortened survey across a variety of different types of HHAs. We 
reviewed the findings of the field test and plan to finalize in the 
future updates to the survey with the intent to shorten it. Potential 
updated HHCAHPS measures have been submitted through the Pre-rulemaking 
Review Process.

B. Summary of the Provision of this Final Rule

    In this final rule, we are finalizing the proposal to add four new 
assessment items and modify one assessment item on the OASIS. Second, 
we are finalizing an update to the removal of the suspension of OASIS 
all-payer data collection. Third, we sought information on future HH 
QRP quality measure concepts. These proposals are further specified in 
the following sections.
    For a detailed discussion of the considerations, we historically 
use for measure selection for the HH QRP quality, resource use, and 
other measures, we refer readers to the CY 2016 HH PPS final rule (80 
FR 68695 through 68696). In the CY 2019 HH PPS final rule with comment 
period (83 FR 56548 through 56550), we finalized the factors we 
consider for removing previously adopted HH QRP measures.

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

    The HH QRP currently includes 19 measures for the CY 2024 program 
year, as described in table 26.
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[[Page 88432]]

[GRAPHIC] [TIFF OMITTED] TR07NO24.056


[[Page 88433]]


BILLING CODE 4120-01-C

D. Proposal To Collect Four New Items as Standardized Patient 
Assessment Data Elements and Modify One Item Collected as a 
Standardized Patient Assessment Data Element Beginning With the CY 2027 
HH QRP

    In this final rule, we have added four new items \12\ to be 
collected as standardized patient assessment data elements under the 
social determinants of health (SDOH) category HH QRP: Living Situation 
(one item); Food (two items); and Utilities (one item). We modified the 
current ``Transportation'' item collected as standardized patient 
assessment data under the SDOH category as described in section 
III.D.5. of this final rule.
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    \12\ Items may also be referred to as ``data elements.''
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1. Definition of Standardized Patient Assessment Data
    Section 1895(b)(3)(B)(v) of the Act requires that for CY 2007 and 
subsequent years, HHAs submit quality data to the Secretary. Section 
1899B(a)(1)(C) of the Act requires, in part, the Secretary to modify 
the post-acute care (PAC) assessment instruments for PAC providers, 
including HHAs, to submit standardized patient assessment data under 
the Medicare program. Section 1899B(b)(1)(A) of the Act requires PAC 
providers to submit standardized patient assessment data under 
applicable reporting provisions (which, for HHAs, is the HH QRP) for 
the admission (start and resumption of care) and discharge of an 
individual (and more frequently as the Secretary deems appropriate). 
Section 1899B(b)(1)(B) of the Act defines standardized patient 
assessment data as data required for at least the quality measures 
described in section 1899B(c)(1) of the Act and that is concerning the 
following categories: (i) functional status, such as mobility and self-
care at admission to a PAC provider and before discharge from a PAC 
provider; (ii) cognitive function, such as ability to express ideas and 
to understand, and mental status, such as depression and dementia; 
(iii) special services, treatments, and interventions, such as need for 
ventilator use, dialysis, chemotherapy, central line placement, and 
total parenteral nutrition; (iv) medical conditions and comorbidities, 
such as diabetes, congestive heart failure, and pressure ulcers; (v) 
impairments, such as incontinence and an impaired ability to hear, see, 
or swallow; and (vi) other categories deemed necessary and appropriate 
by the Secretary.
2. Social Determinants of Health (SDOH) Collected as Standardized 
Patient Assessment Data Elements
    Section 1899B(b)(1)(B)(vi) of the Act authorizes the Secretary to 
collect standardized patient assessment data elements with respect to 
other categories deemed necessary and appropriate. Accordingly, we 
finalized the creation of the SDOH category of standardized patient 
assessment data elements in the CY 2020 HH PPS final rule (84 FR 60597 
through 60608). SDOH are the socioeconomic, cultural, and environmental 
circumstances in which individuals live that impact their health.\13\ 
According to the World Health Organization research shows that the SDOH 
can be more important than health care or lifestyle choices in 
influencing health, accounting for between 30-55% of health 
outcomes.\14\ This is a part of a growing body of research that 
highlights the importance of SDOH on health outcomes. Subsequent to the 
CY 2020 HH PPS final rule, we expanded our definition of SDOH: SDOH are 
the conditions in the environments where people are born, live, learn, 
work, play, worship and age that affect a wide range of health, 
functioning, and quality-of-life outcomes and risks.15 16 17 
This expanded definition aligns our definition of SDOH with the 
definition used by other HHS agencies, including Office of the 
Assistant Secretary for Health (OASH), the Centers for Disease Control 
and Prevention (CDC) and the White House Office of Science and 
Technology Policy (OSTP).18 19 We currently collect seven 
items in this SDOH category of standardized patient assessment data 
elements: ethnicity, race, preferred language, interpreter services, 
health literacy, transportation, and social isolation.\20\ In 
accordance with our authority under section 1899B(b)(1)(B)(vi) of the 
Act, we similarly finalized the creation of the SDOH category of 
standardized patient assessment data elements for skilled nursing 
facilities (SNFs) in the FY 2020 SNF PPS final rule (84 FR 38805 
through 38817), for Inpatient Rehabilitation Facilities (IRFs) in the 
FY 2020 IRF PPS final rule (84 FR 39149 through 39161), and for Long 
Term Acute Hospitals (LTCHs) in the FY 2020 LTCH PPS final rule (84 FR 
42577 through 42579). We also collect the same seven SDOH items in 
these PAC providers' respective patient/resident assessment instruments 
(84 FR 38817, 39161, and 42577, respectively).
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    \13\ Office of the Assistant Secretary for Planning and 
Evaluation (ASPE). Second Report to Congress on Social Risk and 
Medicare's Value-Based Purchasing Programs. June 28, 2020. Available 
at https://aspe.hhs.gov/reports/second-report-congress-social-risk-medicares-value-based-purchasing-programs.
    \14\ World health Organization. Social determinants of health. 
Available at https://www.who.inte/health-topics/social-determinants-of-health#tab=tab_1.
    \15\ Using Z Codes: The Social Determinants of Health (SDOH). 
Data Journey to Better Outcomes.
    \16\ Improving the Collection of Social Determinants of Health 
(SDOH) Data with ICD-10-CM Z Codes. https://www.cms.gov/files/document/cms-2023-omh-z-code-resource.pdf.
    \17\ CMS.gov Measures Management System (MMS). CMS Focus on 
Health Equity. Health Equity Terminology and Quality Measures. 
https://mmshub-impl.cms.gov/about-quality/quality-at-CMS/goals/cms-focus-on-health-equity/health-equity-terminology.
    \18\ Centers for Disease Control and Prevention. Social 
Determinants of Health (SDOH) and PLACES Data.
    \19\ ``U.S. Playbook to Address Social Determinants of Health'' 
from the White House Office of Science and Technology Policy 
(November 2023).
    \20\ These SDOH data are also collected for purposes outlined in 
section 2(d)(2)(B) of the Improving Medicare Post-Acute Care 
Transitions Act (IMPACT Act). For a detailed discussion on SDOH data 
collection under section 2(d)(2)(B) of the IMPACT Act, see the CY 
2020 HH PPS final rule (84 FR 60597 through 60608).
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    Adding access to standardized data relating to SDOH on a national 
level permits us to conduct periodic analyses, and to assess their 
appropriateness as risk adjustors or in future quality measures. Our 
ability to perform these analyses and to make adjustments relies on 
existing data collection of SDOH items from PAC settings. We adopted 
these SDOH items using common standards and definitions across the four 
PAC providers to promote interoperable exchange of longitudinal 
information among these PAC providers, including HHAs, and other 
providers. We believe this information may facilitate coordinated care, 
improve patient focused care planning, and allow for continuity of the 
discharge planning process from PAC settings.
    We noted in our CY 2020 HH PPS final rule that each of the items 
was identified in the 2016 National Academies of Sciences, Engineering, 
and Medicine (NASEM) report as impacting care use, cost, and outcomes 
for Medicare beneficiaries (84 FR 60598 through 60602). At that time, 
we acknowledged that other items may also be useful to understand. The 
SDOH items we proposed to be collected as standardized patient 
assessment data elements under the SDOH category in this rule were also 
identified in the 2016 NASEM report \21\ or the 2020 NASEM

[[Page 88434]]

report \22\ as impacting care use, cost and outcomes for Medicare 
beneficiaries. These items have the potential to affect treatment 
preferences and goals of patients and their caregivers. Identification 
of the SDOH items may also help HHAs be able to offer assistance, by 
connecting patients and their caregivers with these associated needs to 
social support programs, as well as inform our understanding of patient 
complexity.
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    \21\ Social Determinants of Health. Healthy People 2020. https://www.cdc.gov/nchs/healthy_people/hp2020.htmFebruary 2019.
    \22\ National Academies of Sciences, Engineering, and Medicine. 
2020. Leading Health Indicators 2030: Advancing Health, Equity, and 
Well-Being. Washington, DC: The National Academies Press. https://doi.org/10.17226/25682.
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    Health-related social needs (HRSNs) are the resulting effects of 
SDOH, which are individual-level, adverse social conditions that 
negatively impact a person's health or health care.\23\ Examples of 
HRSN include lack of access to food, housing, or transportation, and 
these have been associated with poorer health outcomes, greater use of 
emergency departments and hospitals, and higher health care costs.\24\ 
\25\ Certain HRSNs can lead to unmet social needs that directly 
influence an individual's physical, psychosocial, and functional 
status.\26\ This is particularly true for food security, housing 
stability, utilities security, and access to transportation.\27\ 
Evidence supports the positive impact on health outcomes of 
interventions aimed at addressing HRSNs.\28\
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    \23\ Centers for Medicare & Medicaid Services. ``A Guide to 
Using the Accountable Health Communities Health-Related Social Needs 
Screening Tool: Promising Practices and Key Insights.'' August 2022. 
Available at https://www.cms.gov/priorities/innovation/media/document/ahcm-screeningtool-companion.
    \24\ Berkowitz, S.A., T.P. Baggett, and S.T. Edwards, 
``Addressing Health-Related Social Needs: Value-Based Care or 
Values-Based Care?'' Journal of General Internal Medicine, vol. 34, 
no. 9, 2019, pp. 1916-1918, https://doi.org/10.1007/s11606-019-05087-3.
    \25\ Whitman A, De Lew N, Chappel A, Aysola V, Zuckerman R, & 
Sommers B D. Addressing social determinants of health: Examples of 
successful evidence-based strategies and current federal efforts. 
ASPE (Assistant Secretary for Planning and Evaluation) Office of 
Health Policy. Report HP-2022-12 April 1, 2022. SDOH-Evidence-
Review.pdf (hhs.gov). Accessed 3/1/2024.
    \26\ Hugh Alderwick and Laura M. Gottlieb, ``Meanings and 
Misunderstandings: A Social Determinants of Health Lexicon for 
Health Care Systems: Milbank Quarterly,'' Milbank Memorial Fund, 
November 18, 2019, https://www.milbank.org/quarterly/articles/meanings-and-misunderstandings-a-social-determinants-of-health-lexicon-for-health-care-systems/.
    \27\ Hugh Alderwick and Laura M. Gottlieb, ``Meanings and 
Misunderstandings: A Social Determinants of Health Lexicon for 
Health Care Systems: Milbank Quarterly,'' Milbank Memorial Fund, 
November 18, 2019, https://www.milbank.org/quarterly/articles/meanings-and-misunderstandings-a-social-determinants-of-health-lexicon-for-health-care-systems/.
    \28\ Whitman A, De Lew N, Chappel A, Aysola V, Zuckerman R, & 
Sommers B D. Addressing social determinants of health: Examples of 
successful evidence-based strategies and current federal efforts. 
ASPE (Assistant Secretary for Planning and Evaluation) Office of 
Health Policy. Report HP-2022-12 April 1, 2022. SDOH-Evidence-
Review.pdf (hhs.gov). Accessed 5/29/2024.
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    We proposed to require HHAs collect and submit four new items in 
the OASIS as standardized patient assessment data elements under the 
SDOH category because these items will collect information not already 
captured by the current SDOH items. Specifically, we believe the 
ongoing identification of SDOH will have three significant benefits. 
First, promoting SDOH screening could serve as evidence-based building 
blocks for supporting healthcare providers in actualizing their 
commitment to address disparities that disproportionately impact 
underserved communities. Second, SDOH screening advances health equity 
through identifying potential social needs so that an HHA may address 
those with the patient, their caregivers, and community partners during 
the home health episode and discharge planning process, if 
indicated.\29\ Third, these SDOH items will support ongoing HH QRP 
initiatives by providing data to stratify HHAs' performance on current 
and future quality measures to improve care quality across different 
populations.
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    \29\ American Hospital Association (2020). Health Equity, 
Diversity & Inclusion Measures for Hospitals and Health System 
Dashboards. December 2020. Accessed: January 18, 2022. Available at 
https://ifdhe.aha.org/system/files/media/file/2020/12/ifdhe_inclusion_dashboard.pdf.
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    Additional collection of SDOH items will permit us to continue 
developing the statistical tools necessary to maximize the value of 
Medicare data and improve the quality of care for all beneficiaries. 
For example, we recently developed and released the Health Equity 
Confidential Feedback Reports, which provided data to HHAs on whether 
differences in quality measure outcomes are present for their patients 
by dual-enrollment status and race and ethnicity.\30\ We note that 
advancing health equity by addressing the health disparities that 
underlie the country's health system is one of our strategic pillars 
\31\ and a Biden-Harris Administration priority.\32\
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    \30\ In October 2023, we released two new annual Health Equity 
Confidential Feedback Reports to HHAs: The Discharge to Community 
(DTC) Health Equity Confidential Feedback Report and the Medicare 
Spending Per Beneficiary (MSPB) Health Equity Confidential Feedback 
Report. The PAC Health Equity Confidential Feedback Reports 
stratified the DTC and MSPB measures by dual-enrollment status and 
race/ethnicity. For more information on the Health Equity 
Confidential Feedback Reports, please refer to the Education and 
Outreach materials available here: https://www.cms.gov/medicare/quality/snf-quality-reporting-program/training.
    \31\ Brooks-LaSure, C. (2021). My First 100 Days and Where We Go 
from Here: A Strategic Vision for CMS. Centers for Medicare & 
Medicaid. Available at https://www.cms.gov/blog/my-first-100-days-and-where-we-go-here-strategic-vision-cms.
    \32\ The White House. The Biden-Harris Administration Immediate 
Priorities. https://www.whitehouse.gov/priorities/.
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3. Proposal To Collect Four New Items as Standardized Patient 
Assessment Data Elements Beginning January 1, 2027, for the CY 2027 HH 
QRP Program Year \33\
---------------------------------------------------------------------------

    \33\ Per the authority for the OASIS assessment instrument under 
1891(d)(1), Home Health Conditions of Participation [42 U.S.C. 
1395bbb].
---------------------------------------------------------------------------

    We proposed to require that HHAs collect four new items as 
standardized patient assessment data elements under the SDOH category 
using the OASIS: one item for living situation, as described in section 
III.D.3.a. of this final rule; two items for food, as described in 
section III.D.3.b. of this final rule; and one item for utilities, as 
described in section III.D.3.c of this final rule.
    We selected the final SDOH items from the Accountable Health 
Communities (AHC) HRSN Screening Tool developed for the AHC Model. The 
AHC HRSN Screening Tool is a universal, comprehensive screening for 
HRSNs that was developed by a technical expert panel (TEP) in July 2016 
to discuss opportunities and challenges involved in screening for 
HRSNs, consider and pare down CMS' list of evidence-based screening 
questions, and recommend a short list of questions for inclusion in the 
final tool.34 35 The TEP agreed to prioritize the inclusion 
of five SDOH domains as follows: (1) housing instability (for example, 
homelessness, poor housing quality); (2) food insecurity; (3) 
transportation difficulties; (4) utility assistance needs; and (5) 
interpersonal safety concerns (for example, intimate-partner violence, 
elder abuse, child maltreatment).\36\
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    \34\ Centers for Medicare & Medicaid Services. ``A Guide to 
Using the Accountable Health Communities Health-Related Social Needs 
Screening Tool: Promising Practices and Key Insights.'' August 2022. 
Available at https://www.cms.gov/priorities/innovation/media/document/ahcm-screeningtool-companion.
    \35\ Billioux, A., K. Verlander, S. Anthony, and D. Alley. 2017. 
Standardized screening for health-related social needs in clinical 
settings: The accountable health communities screening tool. 
Discussion Paper, National Academy of Medicine, Washington, DC. 
https://nam.edu/wp-content/uploads/2017/05/Standardized-Screening-for-Health-Related-Social-Needs-in-Clinical-Settings.pdf.
    \36\ More information about the AHC HRSN Screening Tool is 
available on the website at https://innovation.cms.gov/Files/worksheets/ahcm-screeningtool.pdf.

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[[Page 88435]]

    We believe that requiring HHAs to report new items that are 
currently included in the AHC HRSN Screening Tools will further 
standardize the screening of SDOH across patient assessment instruments 
and the various quality reporting programs. For example, our proposal 
will align, in part, with the requirements of the Hospital Inpatient 
Quality Reporting (IQR) Program and the Inpatient Psychiatric Facility 
Quality Reporting (IPFQR) Program. As of January 2024, hospitals are 
required to report whether they have screened patients for the 
standardized SDOH categories of housing stability, food security, and 
access to transportation to meet the Hospital IQR Program 
requirements.\37\ Beginning January 2025, inpatient psychiatric 
facilities (IPFs) will also be required to report whether they have 
screened patients for the same set of SDOH categories.\38\ As we 
continue to standardize data collection across PAC settings, we believe 
using common standards and definitions for new items is important to 
ensure the interoperable exchange of longitudinal information between 
HHAs and other providers to facilitate coordinated care, continuity in 
care planning, and the discharge planning process.
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    \37\ Centers for Medicare & Medicaid Services, FY2023 IPPS/LTCH 
PPS final rule (87 FR 49191 through 49194).
    \38\ Centers for Medicare & Medicaid Services, FY 2024 Inpatient 
Psychiatric Prospective Payment System--Rate Update (88 FR 51107 
through 51121).
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    In the following section we describe each of the four proposed 
items in more detail.
a. Living Situation
    Healthy People 2030 prioritizes economic stability as a key SDOH, 
of which housing stability is a component.39 40 Lack of 
housing stability encompasses several challenges, such as having 
trouble paying rent, overcrowding, moving frequently, or spending the 
bulk of household income on housing.\41\ These experiences may 
negatively affect physical health and make it harder to access health 
care. Lack of housing stability can also lead to homelessness, which is 
housing deprivation in its most severe form.\42\ On a single night in 
2023, roughly 653,100 people, or 20 out of every 10,000 people in the 
United States, were experiencing homelessness.\43\ Rates of chronic 
disease and premature mortality are higher among the unsheltered 
homeless relative to the sheltered.\44\ Older adults (aged 65 years and 
older) have lower rates of experiencing any housing instability 
compared to younger people (8.8% versus 18.7%), but low-income older 
adults may be more at risk for housing instability if they lack the 
resources necessary to secure and/or maintain structurally sound 
housing.\45\ Adults (aged 18-64 years) with disabilities experience 
challenges to securing stable housing including affordability and 
accessibility.\46\ We believe that HHAs can use information obtained 
from the Living Situation assessment item during a patient's initial 
assessment as well as in discharge planning. For example, HH social 
workers can work with patients experiencing housing instability to 
ensure patients are referred to available community resources, such as 
supportive housing programs. HHAs could work in partnership with 
community care hubs and community-based organizations to establish new 
care transition workflows, including referral pathways, contracting 
mechanisms, data sharing strategies, and implementation training that 
can track both health and social needs outcomes to ensure unmet needs, 
such as housing, are successfully addressed through closed loop 
referrals and follow-up.\47\ HHAs could also take action to help 
alleviate a patient's other related costs of living, like food, by 
referring patients to community-based organizations that will allow 
patients' additional resources to be allocated towards housing without 
sacrificing other needs.\48\ Finally, HHAs could use the information 
obtained from the Living Situation assessment item to better coordinate 
with other PAC facilities and agencies during transitions of care, so 
that referrals to address a patient's housing stability are not lost 
during vulnerable transition periods.
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    \39\ https://health.gov/healthypeople/priority-areas/social-determinants-health.
    \40\ Healthy People 2030 is a long-term, evidence-based effort 
led by the HHS that aims to identify nationwide health improvement 
priorities and improve the health of all Americans.
    \41\ Kushel, M.B., Gupta, R., Gee, L., & Haas, J.S. (2006). 
Housing instability and food insecurity as barriers to health care 
among low-income Americans. Journal of General Internal Medicine, 
21(1), 71-77. doi: 10.1111/j.1525-1497.2005.00278.x.
    \42\ Homelessness is defined as ``lacking a regular nighttime 
residence or having a primary nighttime residence that is a 
temporary shelter or other place not designed for sleeping.'' 
Crowley, S. (2003). The affordable housing crisis: Residential 
mobility of poor families and school mobility of poor children. 
Journal of Negro Education, 72(1), 22-38. doi: 10.2307/3211288.
    \43\ The 2023 Annual Homeless Assessment Report (AHAR) to 
Congress. The U.S. Department of Housing and Urban Development 2023. 
https://www.huduser.gov/portal/sites/default/files/pdf/2023-AHAR-Part-1.pdf.
    \44\ Richards J, & Kuhn R. Unsheltered homelessness and health: 
A Literature Review. AJPM focus 2023; 2(1):100043. American Journal 
of Preventive Medicine. Unsheltered Homelessness and Health: A 
Literature Review (sciencedirectassets.com). Accessed 3/1/2024.
    \45\ Bhat, Aarti C., David M. Almeida, Andrew Fenelon, and 
Alexis R. Santos-Lozada. ``A longitudinal analysis of the 
relationship between housing insecurity and physical health among 
midlife and aging adults in the United States.'' SSM-Population 
Health 18 (2022): 101128.
    \46\ Popkin SJ, Hermans A, Oneto AD, Farrell L, Connery M, & 
Cannington A. 2022. People with Disabilities Living in the US Face 
Urgent Barriers to Housing: Federal Programs are not Meeting the 
Housing Needs of Disabled People. Urban Institute. People with 
Disabilities Living in the US Face Urgent Barriers to Housing_0.pdf 
(urban.org). Accessed 5/29/2024.
    \47\ HHS, Call to Action, ``Addressing Health Related Social 
Needs in Communities Across the Nation.'' November 2023. https://aspe.hhs.gov/sites/default/files/documents/3e2f6140d0087435cc6832bf8cf32618/hhs-call-to-action-health-related-social-needs.pdf.
    \48\ Henderson, K.A., Manian, N., Rog, D.J., Robison, E., Jorge, 
E., AlAbdulmunem, M. ``Addressing Homelessness Among Older Adults'' 
(Final Report). Washington, DC: Office of the Assistant Secretary 
for Planning and Evaluation, U.S. Department of Health and Human 
Services. October 26, 2023.
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    Due to the potential negative impacts housing instability can have 
on a patient's health, we proposed to adopt the Living Situation 
assessment item as a new standardized patient assessment data element 
under the SDOH category. This Living Situation assessment item is 
currently collected in the AHC HRSN Screening Tool 49 50 and 
was adapted from the Protocol for Responding to and Assessing Patients' 
Assets, Risks, and Experiences (PRAPARE) tool.\51\ The proposed Living 
Situation item asks: ``What is your living situation today?'' The 
proposed response options are: (1) I have a steady place to live; (2) I 
have a place to live today, but I am worried about losing it in the 
future; (3) I do not have a steady place to live; (4) Patient unable to 
respond; and (5) Patient declines to respond. A draft of the proposed 
Living Situation item can be found in the Downloads section of the HH 
QRP Quality Measures web page at https://www.cms.gov/medicare/quality/home-health/home-health-quality-measures.
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    \49\ More information about the AHC HRSN Screening Tool is 
available on the website at https://innovation.cms.gov/Files/worksheets/ahcm-screeningtool.pdf.
    \50\ The AHC HRSN Screening Tool Living Situation item includes 
two questions. In an effort to limit HHA burden, we are only 
proposing the first question.
    \51\ National Association of Community Health Centers and 
Partners, National Association of Community Health Centers, 
Association of Asian Pacific Community Health Organizations, 
Association OPC, Institute for Alternative Futures. ``PRAPARE.'' 
2017. https://prapare.org/the-prapare-screening-tool/.

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[[Page 88436]]

b. Food
    The U.S. Department of Agriculture (USDA), Economic Research 
Service defines a lack of food security as a household-level economic 
and social condition of limited or uncertain access to adequate 
food.\52\ Adults who are food insecure may be at an increased risk for 
a variety of negative health outcomes and health disparities. For 
example, a study found that food-insecure adults may be at an increased 
risk for obesity.\53\ Nutrition security is also an important component 
that builds on and complements long standing efforts to advance food 
security. The USDA defines nutrition security as ``consistent and 
equitable access to healthy, safe, affordable foods essential to 
optimal health and well-being.'' \54\ While having enough food is one 
of many predictors for health outcomes, a diet low in nutritious foods 
is also a factor.\55\ Studies have shown that older adults struggling 
with food security consume fewer calories and nutrients and have lower 
overall dietary quality than those who are food secure, which can put 
them at nutritional risk. Older adults are also at a higher risk of 
developing malnutrition, which is considered a state of deficit, 
excess, or imbalance in protein, energy, or other nutrients that 
adversely impacts an individual's own body form, function, and clinical 
outcomes. About 50% of older adults are affected by malnutrition, which 
is further aggravated by a lack of food security and poverty.\56\ We 
believe that adopting items to collect and analyze information about a 
patient's food security at home could provide additional insight into 
their health complexity and help facilitate coordination with other 
healthcare providers, facilities, and agencies during transitions of 
care, so that referrals to address a patient's food security are not 
lost during vulnerable transition periods. For example, an HHA's 
registered nurse (RN) or other clinically qualified nutrition 
professional could work with the patient to plan healthy, affordable 
food choices prior to discharge.\57\ HHAs could also refer any patient 
that indicates lack of food security to government initiatives such as 
home delivered meals programs provided by Area Agencies on Aging,\58\ 
the Supplemental Nutrition Assistance Program (SNAP), and food 
pharmacies (programs to increase access to healthful foods by making 
them affordable), initiatives that have been associated with lower 
health care costs and reduced hospitalization and emergency department 
visits.\59\
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    \52\ U.S. Department of Agriculture, Economic Research Service 
(n.d.). Definitions of food security. Retrieved March 10, 2022, from 
https://www.ers.usda.gov/topics/food-nutrition-assistance/food-security-in-the-u-s/definitions-of-food-security/.
    \53\ Hernandez, D.C., Reesor, L.M., & Murillo, R. (2017). Food 
insecurity and adult overweight/obesity: Gender and race/ethnic 
disparities. Appetite, 117, 373-378.
    \54\ Food and Nutrition Security (n.d.). USDA. https://www.usda.gov/nutrition-security.
    \55\ National Center for Health Statistics (2022 September 6). 
Exercise or Physical Activity. Retrieved from Centers for Disease 
Control and Prevention: https://www.cdc.gov/nchs/fastats/exercise.htm.
    \56\ Food Research & Action Center (FRAC). ``Hunger is a Health 
Issue for Older Adults: Food Security, Health, and the Federal 
Nutrition Programs.'' December 2019. https://frac.org/wp-content/uploads/hunger-is-a-health-issue-for-older-adults-1.pdf.
    \57\ Schroeder K, Smaldone A. Food Insecurity: A Concept 
Analysis. Nurse Forum. 2015 Oct-Dec;50(4):274-84. doi: 10.1111/
nuf.12118. Epub 2015 Jan 21. PMID: 25612146; PMCID: PMC4510041.
    \58\ Administration for Community Living. Nutrition Services. 
Last updated 02/02/2024. Accessed 04/19/2024. https://acl.gov/programs/health-wellness/nutrition-services.
    \59\ Tsega M, Lewis C, McCarthy D, Shah T, Coutts K. Review of 
Evidence for Health-Related Social Needs Interventions. July 2019. 
The Commonwealth Fund. https://www.commwealthfund.org/sites/default/files/2019-07/ROI-EVIDENCE-REVIEW-FINAL-VERSION.pdf.
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    We proposed to adopt two new food-related standardized patient 
assessment data elements under the SDOH category. These proposed items 
are based on the Food data elements currently collected in the AHC 
Screening Tool and were adapted from the U.S. Department of Agriculture 
18-item Household Food Security Survey (HFSS).\60\ The first proposed 
Food item states: ``Within the past 12 months, you worried that your 
food will run out before you got money to buy more.'' The second 
proposed Food item states: ``Within the past 12 months, the food you 
bought just didn't last and you didn't have money to get more.'' We 
propose the same response options for both items: (1) Often true; (2) 
Sometimes true; (3) Never True; (4) Patient declines to respond; and 
(5) Patient unable to respond. A draft of the proposed Food items to be 
adopted as standardized patient assessment data elements under the SDOH 
category can be found in the Downloads section of the HH QRP Quality 
Measures web page at https://www.cms.gov/medicare/quality/home-health/home-health-quality-measures.
---------------------------------------------------------------------------

    \60\ More information about the HFSS tool can be found at 
https://www.ers.usda.gov/topics/food-nutrition-assistance/food-security-in-the-u-s/survey-tools/.
---------------------------------------------------------------------------

c. Utilities
    A lack of energy (utility) security can be defined as an inability 
to adequately meet basic household energy needs.\61\ According to the 
Department of Energy, one in three households in the U.S. are unable to 
adequately meet basic household energy needs.\62\ The median energy 
burden for rural households of older adults is considerably higher than 
that for households without older adults.\63\ The consequences 
associated with a lack of utility security are represented by three 
primary dimensions: economic, physical, and behavioral. Patients with 
low incomes are disproportionately affected by high energy costs, and 
they may be forced to prioritize paying for housing and food over 
utilities. Among older adults, food insecurity and high energy costs 
together are prevalent.\64\ Some patients with low incomes may face 
limited housing options and be at increased risk of living in lower-
quality physical conditions with malfunctioning heating and cooling 
systems, poor lighting, and outdated plumbing and electrical systems. 
Finally, patients with a lack of utility security may use concerning 
behavioral approaches to cope, such as using stoves and space heaters 
for heat.\65\ In addition, data from the Department of Energy's U.S. 
Energy Information Administration confirm that a lack of energy 
security disproportionately affects certain populations, such as low-
income and African American households.\66\ The effects of a lack of 
utility security include vulnerability to environmental exposures such 
as dampness, mold, and thermal discomfort in the home, which have 
direct effect on patients' health.\67\

[[Page 88437]]

For example, research has shown associations between a lack of energy 
security and respiratory conditions as well as mental health-related 
disparities and poor sleep quality in vulnerable populations such as 
the elderly, children, the socioeconomically disadvantaged, and the 
medically vulnerable.\68\ We believe adopting an item to collect 
information about a patient's utility security upon start or resumption 
of care in HHAs will facilitate the identification of patients who may 
not have utility security and who may benefit from engagement efforts. 
For example, HHAs could use the information on utility security to help 
connect identified patients in need, such as older adults, to programs 
that can help pay for home energy (heating/cooling) costs, like the 
Low-Income Home Energy Assistance Program (LIHEAP) \69\ or receive 
broadband internet service through the Affordable Connectivity 
Program.\70\ HHAs can also partner with community care hubs and 
community-based organizations to assist patients in applying for these 
and other local utility assistance programs, as well as helping them 
navigate the enrollment process.\71\
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    \61\ Hern[aacute]ndez D. Understanding 'energy insecurity' and 
why it matters to health. Soc Sci Med. 2016 Oct; 167:1-10. doi: 
10.1016/j.socscimed.2016.08.029. Epub 2016 Aug 21. PMID: 27592003; 
PMCID: PMC5114037.
    \62\ U.S. Energy Information Administration. ``One in Three U.S. 
Households Faced Challenges in Paying Energy Bills in 2015.'' 2017 
Oct 13. https://www.eia.gov/consumption/residential/reports/2015/energybills/.
    \63\ Simes, Miranda, Farzana Khan, and Diana Hern[aacute]ndez. 
``Energy Insecurity and Social Determinants of Health.'' In Handbook 
of Social Sciences and Global Public Health, pp. 2119-2137. Cham: 
Springer International Publishing, 2023.
    \64\ Simes, Miranda, Farzana Khan, and Diana Hern[aacute]ndez. 
``Energy Insecurity and Social Determinants of Health.'' In Handbook 
of Social Sciences and Global Public Health, pp. 2119-2137. Cham: 
Springer International Publishing, 2023.
    \65\ Hern[aacute]ndez D. ``What `Merle' Taught Me About Energy 
Insecurity and Health.'' Health Affairs, VOL.37, NO.3: Advancing 
Health Equity Narrative Matters. March 2018. https://doi.org/10.1377/hlthaff.2017.1413.
    \66\ U.S. Energy Information Administration. ``One in Three U.S. 
Households Faced Challenges in Paying Energy Bills in 2015.'' 2017 
Oct 13. https://www.eia.gov/consumption/residential/reports/2015/energybills/.
    \67\ Shahrestanaki, S.K., Rafii, F., Najafi Ghezeljeh, T. et al. 
Patient safety in home health care: a grounded theory study. BMC 
Health Serv Res 23, 467 (2023). https://doi.org/10.1186/s12913-023-09458-9.
    \68\ Siegel, Eva Laura, Kathryn Lane, Ariel Yuan, Lauren A. 
Smalls-Mantey, Jennifer Laird, Carolyn Olson, and Diana 
Hern[aacute]ndez. ``Energy Insecurity Indicators Associated With 
Increased Odds Of Respiratory, Mental Health, And Cardiovascular 
Conditions: Study examines energy insecurity and health 
conditions.'' Health Affairs 43, no. 2 (2024): 260-268.
    \69\ Low Income Home Energy Assistance Program (LIHEAP) [verbar] 
The Administration for Children and Families (hhs.gov) (https://www.acf.hhs.gov/ocs/programs/liheap).
    \70\ https://www.fcc.gov/broadbandbenefit.
    \71\ National Council on Aging (NCOA). ``How to Make It Easier 
for Older Adults to Get Energy and Utility Assistance.'' Promising 
Practices Clearinghouse for Professionals. Jan 13, 2022. https://www.ncoa.org/article/how-to-make-it-easier-for-older-adults-to-get-energy-and-utility-assistance.
---------------------------------------------------------------------------

    We proposed to adopt a new Utilities item as a new standardized 
patient assessment data element under the SDOH category. This proposed 
item is based on the Utilities item currently collected in the AHC HRSN 
Screening Tool and was adapted from the Children's Sentinel Nutrition 
Assessment Program (C-SNAP) survey.\72\ The proposed Utilities item 
asks: ``In the past 12 months, has the electric, gas, oil, or water 
company threatened to shut off services in your home?'' The proposed 
response options are: (1) Yes; (2) No; (3) Already shut off; (4) 
Patient unable to respond; and (5) Patient declines to respond. A draft 
of the proposed Utilities item to be adopted as a standardized patient 
assessment data element under the SDOH category can be found in the 
downloads section of the HH QRP Quality Measures web page at https://www.cms.gov/medicare/quality/home-health/home-health-quality-measures.
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    \72\ This validated survey was developed as a clinical indicator 
of household energy security among pediatric caregivers. Cook, J.T., 
D.A. Frank., P.H. Casey, R. Rose-Jacobs, M.M. Black, M. Chilton, S. 
Ettinger de Cuba, et al. ``A Brief Indicator of Household Energy 
Security: Associations with Food Security, Child Health, and Child 
Development in US Infants and Toddlers.'' Pediatrics, vol. 122, no. 
4, 2008, pp. e874-e875. https://doi.org/10.1542/peds.2008-0286.
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4. Stakeholder Input
    We developed our proposal after considering the feedback we 
received when we proposed the creation of the SDOH category of 
standardized patient assessment data elements in the CY 2020 HH PPS 
rule (84 FR 34677 through 34684). Commenters were generally in favor of 
the concept of collecting SDOH data elements and stated that if 
implemented appropriately the data could be useful in identifying and 
addressing health care disparities, as well as refining the risk 
adjustment of outcome measures. We incorporated this input into the 
development of the proposal.
    We invited comment on the proposal to adopt four new items as 
standardized patient assessment data elements under the SDOH category 
beginning with the CY 2027 HH QRP: one living situation item; two food 
items; and one utilities item.
    Comment: The majority of commenters supported the proposal. 
Supportive comments noted the importance and relevance of SDOH to home 
health and the importance of interoperability. Some commenters noted 
that their home health agencies are already collecting this information 
and have established community partnerships to address SDOH.
    Response: CMS appreciate commenters' support for the proposal and 
agrees that SDOH are important and relevant to home health. CMS also 
agrees that interoperability is important to measure quality and 
advance health equity, and thus we propose data elements that are 
standardized across the PAC settings. CMS appreciates that some home 
health agencies are already addressing SDOH by collecting information 
and working with community partners.
    Comment: Some commenters expressed support for the proposal and 
suggested changes, including expanding the assessment to capture 
overall financial need, and embedding the American Healthy Communities 
(AHC) screening tool in the assessment instruments. One commenter 
suggested that CMS require collection of the information but not 
specify the tool or instrument to be used.
    Response: CMS appreciates the commenters' suggestions and 
acknowledge that patients' overall financial need and other data 
elements from the AHC screening tool are important. However, the 
proposed data elements have been identified as impacting care use, cost 
and outcomes for Medicare beneficiaries. These items have the potential 
to affect treatment preferences and goals of patients and their 
caregivers. Identification of the SDOH items may also enable HHAs to 
offer assistance, by connecting patients and their caregivers with 
these associated needs to social support programs, as well as inform 
our understanding of the level of patient clinical complexity. We 
believe the proposed data elements offer the greatest potential benefit 
without undue burden for patients and HHAs.
    Comment: Commenters that supported the proposal also expressed 
implementation concerns that vendors be provided enough time to prepare 
for the changes; that home health agencies be provided time and 
resources to educate staff on the changes; that OASIS revisions are too 
frequent and burdensome for agencies; and that implementation of the 
proposal would be burdensome. Some commenters cautioned that SDOH needs 
identified must be addressed, and one suggested that CMS should provide 
additional reimbursement to HHAs for the follow-up required to address 
identified needs.
    Response: CMS acknowledges and appreciates the commenters' concerns 
and suggestions. CMS is finalizing the SDOH data elements in this 
CY2025 final rule with an effective date of January 1, 2027, to ensure 
that vendors and HHAs have sufficient time to prepare for 
implementation of data collection. CMS will make training available to 
HHAs on the changes to the OASIS, consistent with education and 
training resources for previous revisions to the OASIS instrument. CMS 
acknowledges that revisions to the OASIS require that providers expend 
time, effort, and resources to prepare for the changes. CMS is 
committed to proposing revisions to the OASIS no more frequently than 
every two years. CMS agrees that patients' needs should be addressed by 
the HHA, consistent with applicable rules and regulations, although we 
note that the proposal does not specify a requirement for how HHAs may 
address patients' needs.
    Comment: A commenter suggested that CMS consider home health SDOH

[[Page 88438]]

data differently than data from the PAC institutional settings, noting 
that in home health, an HHA staff member often walks into the home 
where a situation caused by or related to one or more SDOH is already 
happening and may be at a crisis level. In those situations, HHAs may 
not have the capacity to remediate identified issues since this would 
take significantly more time than merely conducting the assessment. The 
commenter suggested that requirements that HHA staff respond to patient 
and caregiver crises may trigger obligations such as mandatory 
reporting to the local adult protective services agency, or requiring 
that the staff member call county health officials to condemn a 
patient's current living space even when no housing alternative exists. 
These requirements would violate the trust the HHA is trying to 
establish through its services and jeopardize individuals' ability to 
access needed services for which they are eligible. The commenter 
suggests that the SDOH data elements not be used as process or outcome 
measures without additional CMS support for HHAs and recommends that 
the SDOH data elements be considered an opportunity to gather more 
information on populations accessing home health services.
    Response: CMS acknowledges that the home health setting differs 
from that of the institutional PAC settings. However, we believe that 
HHAs can benefit from this information to facilitate coordinated care, 
improve patient focused care planning, and allow for continuity of the 
discharge planning process. Ultimately, CMS believes that first, 
screening for SDOH could serve as evidence-based building blocks for 
supporting healthcare providers in actualizing their commitment to 
address disparities that disproportionately impact underserved 
communities. Second, screening for SDOH advances health equity through 
identifying potential social needs of individuals so the HHA may 
address those with the patient, their caregivers, and community 
partners during the home health episode and discharge planning process, 
if indicated.\73\ Third, these SDOH items will support ongoing HH QRP 
initiatives by providing data with which to stratify HHAs' performance 
on current and future quality measures to improve care quality across 
different populations.
---------------------------------------------------------------------------

    \73\ American Hospital Association (2020). Health Equity, 
Diversity & Inclusion Measures for Hospitals and Health System 
Dashboards. December 2020. Accessed: January 18, 2022. Available at: 
https://ifdhe.aha.org/system/files/media/file/2020/12/ifdhe_inclusion_dashboard.pdf.
---------------------------------------------------------------------------

    Comment: Commenters that did not support the proposal acknowledged 
that SDOH information was important, but stated that adding four data 
elements to the OASIS and modifying a fifth would be burdensome. One 
commenter noted that revisions to the OASIS are too frequent and 
recommended that CMS limit revisions to intervals of no less than four 
years. One commenter suggested that the proposed ``living situation'' 
data element duplicates other information that is already collected, 
and recommended that the look-back for the ``utilities'' data element 
be changed from 12 months to three to capture more reliable, valid, and 
timely information. Another commenter encouraged CMS to consider using 
SDOH information as part of the risk-adjustment of outcome quality 
measures. A commenter stated the proposal is not aligned with health-
related social needs reporting requirements across the care continuum 
and that further testing and refinement are needed to ensure the 
proposed items work as intended in this setting. This commenter noted 
the proposed data elements are not standardized with those in the 
Inpatient and Inpatient Psychiatric Facility Quality Reporting 
Programs, so are not interoperable, and also noted that inpatient 
psychiatric facilities may use any standardized health-related social 
needs screening tool. This commenter noted that CMS' evaluation of the 
AHC HRNS screening tool in the AHC Model showed that screening did not 
appear to increase beneficiary connection to community resources or 
health-related social need resolution, and they recommended that CMS 
conduct further testing and develop clearer implementation guidance 
before adopting the proposed data elements in the HHQRP. This commenter 
also requested that CMS articulate its vision for how the health-
related social need information collected by the proposed data elements 
would be used in its quality and payment programs, noting for example 
that measures holding HHAs accountable for community-based outcomes 
such as connection to community resources and resolution of health-
related social need is outside the scope of covered home health 
services as defined by Medicare.
    Response: We acknowledge the commenters' concerns and appreciate 
their suggestions. As previously stated, CMS acknowledges that 
revisions to the OASIS require HHAs' time, effort, and resources, and 
we are committed to proposing revisions to the OASIS no more frequently 
than every two years. CMS disagrees that the proposed ``Living 
Situation'' data element duplicates information that is already 
collected because it addresses housing insecurity, which is not part of 
the information captured in the current OASIS. CMS appreciates the 
suggestion to reduce the look-back period for the ``Utilities'' data 
element and will take this into consideration as we review data 
submitted. CMS acknowledges that the SDOH data elements finalized in 
this rule are not aligned with those of the inpatient QRPs; however we 
believe that standardization across the PAC settings is an important 
step in advancement towards interoperability. CMS believes that the 
data elements finalized in this rule are not setting-specific, and that 
the testing conducted in their development has been sufficiently 
rigorous that we can adopt the data elements into the OASIS and the 
other PAC instruments with confidence.
    After consideration of the public comments we received, we are 
finalizing our proposal to adopt four new items as standardized patient 
assessment data elements under the SDOH category beginning with the CY 
2027 HH QRP.
5. Modification of the ``Transportation'' Item Beginning With the CY 
2027 HH QRP Program Year
    Beginning January 1, 2023, HHAs began collecting seven standardized 
patient assessment data elements under the SDOH category on the OASIS 
Version E. One of these items, A1250. ``Transportation'', collects data 
on whether a lack of transportation has kept a patient from getting to 
and from medical appointments, meetings, work, or from getting things 
they need for daily living. This item was adopted as a standardized 
patient assessment data element under the SDOH category in the CY 2020 
HH PPS final rule (84 FR 60478). As we discussed in the CY 2020 HH PPS 
final rule, we continue to believe that access to transportation for 
ongoing health care and medication access needs, particularly for those 
with chronic diseases, is essential to successful chronic disease 
management and the collection of a ``Transportation'' item will 
facilitate the connection to programs that can address identified 
needs.
    As part of our routine item and measure monitoring work, we 
continue to assess the implementation of the new SDOH items. We have 
identified an opportunity to improve the data collection for A1250. 
``Transportation'' by aligning it with the Transportation category 
collected in our other programs. Specifically, we proposed to

[[Page 88439]]

modify the current ``Transportation'' item so that it aligns with a 
``Transportation'' item collected on the AHC HRSN Screening Tool 
available to the IPFQR and IQR Programs. Data element A1250, 
``Transportation'', currently collected in the OASIS asks patients: 
``Has lack of transportation kept you from medical appointments, 
meetings, work, or from getting things needed for daily living?'' The 
response options are: ``(A) Yes, it has kept me from medical 
appointments or from getting any medications''; ``(B) Yes, it has kept 
me from non-medical meetings, appointments, work, or from getting 
things that I need''; ``(C) No''; ``(X) Patient unable to respond''; 
and ``(Y) Patient declines to respond''. By comparison, the 
``Transportation'' item collected in the AHC HRSN Screening Tool asks, 
``In the past 12 months, has lack of reliable transportation kept you 
from medical appointments, meetings, work or from getting things needed 
for daily living?'' The two response options are: ``(1) Yes''; and 
``(2) No.'' Consistent with the AHC HRSN Screening Tool, we proposed to 
modify the A1250. ``Transportation'' item currently collected in the 
OASIS in two ways: (1) revise the look-back period for when the patient 
experienced lack of reliable transportation; and (2) simplify the 
response options.
    While the current ``Transportation'' assessment item uses a look-
back period of six to 12 months, we believe use of a 12-month lookback 
period will reduce ambiguity for both patients and clinicians, and 
therefore improve the validity of the data collected. Second, we 
proposed to simplify the response options. Currently, HHAs separately 
collect information on whether a lack of reliable transportation has 
kept the patient from medical appointments or from getting medications, 
and whether a lack of transportation has kept the patient from non-
medical meetings, appointments, work, or from getting things they need. 
Although transportation barriers can directly affect a person's ability 
to attend medical appointments and obtain medications, a lack of 
transportation can also affect a person's health in other ways, 
including accessing goods and services, obtaining adequate food and 
clothing, and social activities.\74\ The proposed modified 
``Transportation'' item will collect information on whether a lack of 
reliable transportation has kept the patient from medical appointments, 
meetings, work or from getting things needed for daily living, rather 
than collecting the information separately. As discussed previously, we 
believe reliable transportation services are fundamental to a person's 
overall health, and as a result, the burden of collecting this 
information separately outweighs its potential benefit.
---------------------------------------------------------------------------

    \74\ Victoria Transport Policy Institute (2016 August 25). Basic 
access and basic mobility: Meeting society's most important 
transportation needs. Retrieved from https://www.vtpi.org/tdm/tdm103.htm.
---------------------------------------------------------------------------

    For the reasons stated, we proposed to modify the current A1250 
``Transportation'' based on the ``Transportation'' item adopted for use 
in the AHC HRSN Screening Tool and adapted from the PRAPARE tool. The 
proposed ``Transportation'' item asks: ``In the past 12 months, has a 
lack of reliable transportation kept you from medical appointments, 
meetings, work or from getting things needed for daily living?'' The 
proposed response options are: (0) Yes; (1) No; (7) Patient declines to 
respond; and (8) Patient unable to respond. A draft of the proposed 
``Transportation'' item to be adopted as a standardized patient 
assessment data element under the SDOH category can be found on the HH 
QRP Quality Measures web page at https://www.cms.gov/medicare/quality/home-health/home-health-quality-measures/downloads.
    We invited comment on the proposal to modify the current 
``Transportation'' item previously adopted as a standardized patient 
assessment data element under the SDOH category beginning January 1, 
2027, with the CY 2027 HH QRP.
    Comment: Most commenters supported the modification of the 
``Transportation'' item to align with the AHC HRSN Screening Tool. Some 
even suggested adopting more components of the AHC tool to the OASIS 
assessment tool.
    Response: CMS appreciate commenters' support for the proposal and 
agrees that the adoption of this AHC item improves consistency with 
other provider settings.
    Comment: A few commenters noted a concern related to the burden 
required to update the OASIS with the replacement of the current 
``Transportation'' item.
    Response: CMS acknowledges there is a change to the OASIS that will 
be required with the modification of the ``Transportation'' item but 
there will be sufficient guidance to clarify the correct completion of 
the new item. Additionally, the new item does not substantially 
increase effort in completing the OASIS tool relative to the current 
``Transportation'' item.
    After consideration of the public comments we received, we are 
finalizing our proposal to modify the current ``Transportation'' item 
previously adopted as a standardized patient assessment data element 
under the SDOH category beginning January 1, 2027, with the CY 2027 HH 
QRP.

E. Proposal To Update OASIS All-Payer Data Collection

    In the CY 2023 HH PPS final rule CMS finalized the end of the 
temporary suspension of OASIS data collection on non-Medicare/non-
Medicaid HHA patients and the requirement for HHAs to submit all-payer 
OASIS data for purposes of the HH QRP, beginning with the CY 2027 
Program Year (87 FR 66862 through 66865). Consistent with the two-
quarter phase-in that we typically use when changing data submission 
items or requirements, HHAs will have an opportunity to begin 
submitting this data for patients discharged between January 1, 2025, 
through June 30, 2025, but we will not use that phase-in data to make a 
compliance determination. We noted that the new all-payer OASIS data 
reporting will be required beginning with the CY 2027 program year, 
with data for that program year required for patients discharged 
between July 1, 2025, and June 30, 2026. For HHAs to operationalize 
this requirement, CMS determined that further details will be needed to 
clarify OASIS data collection and submission for non-Medicare/non-
Medicaid patients. The CY23 final rule referenced discharge as the time 
point to identify when all-payer data collection will start but did not 
address the other data collection time points.
    To clarify expectations around the start of OASIS all-payer data 
collection we proposed to establish a change from data collection 
beginning with the OASIS discharge time point to using the start of 
care (SOC) time point. The SOC is the first assessment that can be 
submitted for a non-Medicare/non-Medicaid patient, either on or after 
January 1, 2025, for the phase-in (voluntary) period or on or after 
July 1, 2025, for the mandatory period. We will use the M0090 ``Date 
Assessment Completed'' date of the SOC assessment to identify non-
Medicare/non-Medicaid patient assessments in the phase-in and mandatory 
periods.
    Using the SOC time point ensures HHA characteristics (for example, 
Agency's CMS Certification Number (CCN), State and Branch ID#s) and 
patient-specific information (for example, patient name, State, zip 
code, Social Security number (SSN), gender, date of birth (DOB), 
payment source) are collected for each non-Medicare/non-Medicaid 
patient assessment at the start

[[Page 88440]]

of all-payer OASIS data collection. After these are collected and 
submitted with the SOC assessment, they are resubmitted with each 
subsequent OASIS submission (that is, ROC, recert, other follow up, 
transfer, discharge, death at home). Using the SOC time point will 
ensure that baseline data is available for use in calculating or risk-
adjusting quality measures, and in linking to prior OASIS assessments. 
The data will also be available for matching purposes to support use of 
the current quality assessments only (QAO) metric used in the annual 
payment update (APU) calculation.
    The Medicare Prescription Drug, Improvement, and Modernization Act 
of 2003 (Pub. L. 108-173; December 8, 2003) finalized the temporary 
suspension of OASIS requirements for collection of data on non-
Medicare/non-Medicaid patients.\75\ The CY 2023 HH PPS final rule ends 
this temporary suspension of OASIS data collection for non-Medicare/
non-Medicaid patients. CMS is providing a voluntary phase-in period for 
HHAs to begin OASIS data collection and submission for all non-
Medicare/non-Medicaid patients.
---------------------------------------------------------------------------

    \75\ www.congress.gov/108/statute/STATUTE-117/STATUTE-117-Pg2066.pdf.
---------------------------------------------------------------------------

     Prior to January 1, 2025--Per the HH CoPs and OASIS 
guidance, HHAs are required to collect and submit OASIS assessments for 
all skilled Medicare and/or Medicaid patients, with some exemptions. 
OASIS assessment time points include start of care, resumption of care, 
recertification, other follow-up, transfer, discharge, and death at 
home. The criteria for patients exempt from OASIS data collection are 
not changing and will continue to include patients under 18, patients 
receiving maternity services, and patients receiving only personal 
care, housekeeping or chore services.
     January 1, 2025, through June 30, 2025--For non-Medicare/
non-Medicaid patients who are not exempt from OASIS data collection, 
and who begin receiving home health care services with an OASIS SOC 
M0090 date from January 1, 2025, through June 30, 2025, OASIS data 
collection and submission are voluntary. When OASIS data collection and 
submission are started for a non-Medicare/non-Medicaid patient with the 
SOC OASIS assessment, HHAs may but are not required to complete all 
subsequent OASIS time point assessments related to the patient's home 
health stay (that is, resumption of care, recertification, other follow 
up, transfer, discharge, and death at home) including assessments 
completed on or after July 1, 2025.
     Beginning July 1, 2025--For patients with any pay source 
who are not exempt from OASIS data collection, and who begin receiving 
home health care services with an OASIS SOC M0090 date on or after July 
1, 2025, OASIS data collection and submission to the internet Quality 
Improvement Evaluation System (iQIES) are required. This includes the 
SOC OASIS as well as any subsequent OASIS time point assessments 
relevant to the patient's home health stay (that is, resumption of 
care, recertification, other follow up, transfer, discharge, and death 
at home).
    We invited comment on the proposal to update requirements for OASIS 
all-payer data collection beginning January 1, 2025.
    Comment: Those who supported the proposal emphasized that a 
voluntary phase-in and the use of the start of care date to initiate 
all payer submission would provide consistency with how the policy is 
implemented. Another commenter noted the resumption of all payer OASIS 
data collection and submission aligns policies and reporting across 
post-acute care settings and patient subsets and provides a fuller, 
more accurate representation of home health quality of care for use in 
beneficiary health care decision making, policy development, and health 
services research.
    Response: CMS thanks commenters for providing feedback on the 
proposal. The goal of implementing all-payer data collection and 
submission is to facilitate a better understanding of quality of care 
provided to patients in Medicare-certified home health and post-acute 
care settings in general, regardless of payor source.
    Comment: Some commenters acknowledged the importance of OASIS all-
payer data but expressed concerns about how CMS will use the data in 
the HHQRP and the HHVBP.
    Response: CMS acknowledges concerns about how the data collected 
with the implementation of all-payer data collection and submission 
will be utilized. CMS expects to use this data to gain a better 
understanding of the overall quality of care provided by Medicare-
certified providers and the patients they serve, regardless of payor 
source.
    Comment: Some commenters raised questions about how the all-payer 
policy would be implemented for patients without any payor source and 
in other scenarios such as how to complete OASIS for non-Medicare 
patients already on service, or that transfer to the hospital, or for 
payer changes. One commenter asked about whether PDGM rules for a 60-
day episode and 30-day payment period apply to all payers.
    Response: CMS thanks commenters for the questions regarding 
implementation of all-payer data collection and submission. All-payer 
data collection and submission is intended for any patient receiving 
skilled home health care service that would meet requirements for an 
OASIS assessment. As noted in the proposal, data collection at time 
points outside of start of care for patients already on home health 
care service before the implementation of mandatory all-payer data 
collection and submission will not be required. The implementation of 
mandatory all-payer data collection and submission is also not intended 
to impact payment policy.
    Comment: Another commenter expressed concern about the implications 
for patient privacy, particularly for patient care funded by non-
government payers.
    Response: CMS acknowledges privacy concerns with the implementation 
of the all-payer data collection and submission. Data security and 
patient privacy are priorities for CMS. CMS intends to follow all 
Federal guidelines related to data security and patient privacy.
    Comment: Commenters who opposed the proposal most often raised the 
issue of the burden of implementing the new policy. One commenter noted 
that deep labor shortages, particularly for nurses and home health 
aides, would impact availability of staff to meet the expanded data 
collection requirement. Some raised concerns about the new policy's 
effect on reimbursement and that completing all required home health 
admissions could become more difficult.
    Response: Related to the concern about burden, as noted when the 
all-payer data collection policy was first proposed, CMS expects that 
the six-month voluntary submission period will allow providers the time 
and experience to effectively implement the new policy. As clinical 
assessment of all patients is an important standard, CMS anticipates 
the OASIS assessment will replace other assessment tools currently in 
place for non-Medicare/Medicaid payor sources.
    After consideration of the public comments we received, we are 
finalizing our proposal to update requirements for OASIS all-payer data 
collection beginning January 1, 2025.

[[Page 88441]]

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

1. Background
    We refer readers to the regulatory text at Sec.  484.45 for 
information regarding the current policies for reporting HH QRP data.
2. Proposed Reporting Schedule for the Submission of SDOH Assessment 
Items Beginning January 1, 2027, With the CY 2027 HH QRP
    As discussed in section III.D.3. of this final rule, we proposed to 
adopt four new items as standardized patient assessment data elements 
in the SDOH category: one living situation item, two food items, and 
one utilities item, and to modify the ``Transportation'' item in 
section III.D.5. of this rule beginning January 1, 2027, with the CY 
2027 HH QRP.
    We proposed that HHAs will be required to report these new 
assessment items using the OASIS beginning with patients admitted on 
January 1, 2027, for purposes of the CY 2027 HH QRP program year. 
Starting in CY 2027, HHAs will be required to submit data for the 
entire calendar year, corresponding to the CY 2028 HH QRP program year 
with respect to OASIS submission requirements.
    We also proposed that HHAs that submit the living situation, food, 
utilities, and transportation items with respect to start or resumption 
of care will be deemed to have submitted those assessment items with 
respect to both start or resumption of care and discharge, because it 
is unlikely that the assessment of those items at start or resumption 
of care will differ from the assessment of the same item at discharge. 
A draft of the proposed assessment items is available in the Downloads 
section of the HH QRP Quality Measures web page at https://www.cms.gov/medicare/quality/home-health/home-health-quality-measures. As we noted 
in section III.D.5 of this final rule, we continue to assess the 
implementation of the new items in the SDOH category, including A1250. 
``Transportation'', as part of our routine assessment item and measure 
monitoring work. We analyzed the data home health agencies reported 
from January 1, 2023, through September 30, 2023 (Q1 2023-Q3 2023) and 
found that home health patient responses do not significantly change 
from admission to discharge. Specifically, the proportion of patients 
who responded ``Yes'' to the A1250 ``Transportation'' item at start of 
care or resumption of care (8.87 percent) versus at discharge to 
community (5.71 percent) differed by only 3.16 percentage points during 
this period. We find these results convincing, and therefore are 
proposing to require HHAs to submit the proposed item, 
``Transportation'', at the start and resumption of care only.
    We invited public comment on our proposal to collect data on the 
following items in the SDOH category start or resumption of care 
beginning January 1, 2027 with the CY 2027 HH QRP program year: one 
Living Situation item as described in section III.D.3.a of this final 
rule; two Food items, as described in section III.D.3.b of this final 
rule; one Utilities item as described in section III.D.3.c of this 
final rule; and one ``Transportation'' item as described in section 
III.D.5 of this final rule.
    A majority of commenters supported the proposal. Supportive 
comments included that SDOH are important and relevant to home health, 
and that interoperability is important. Some commenters noted that 
their home health agencies are already collecting this information and 
have established community partnerships to address SDOH.
    Response: CMS appreciate commenters' support for the proposal and 
agrees that SDOH are important and relevant to home health. CMS also 
agrees that interoperability is important to measure quality and 
advance health equity, and thus we propose data elements that are 
standardized across the PAC settings. CMS appreciates that some home 
health agencies are already addressing SDOH by collecting information 
and working with community partners.
    Commenters that supported the proposal expressed concerns about 
implementation including that the vendors be provided enough time to 
prepare for the changes, that home health agencies be provided time and 
resources to educate staff on the changes, that OASIS revisions are too 
frequent and burdensome for agencies and that implementation of the 
proposal would be burdensome. Some commenters cautioned that SDOH needs 
identified must be addressed, and one suggested that CMS should provide 
additional reimbursement to HHAs for the follow-up required to address 
identified needs.
    Response: CMS acknowledge the commenters' concerns and appreciate 
their suggestions. CMS is proposing the SDOH data elements in the CY 
2025 HH PPS proposed rule with an effective date to begin collection 
via the OASIS instrument of January 1, 2027, to ensure that vendors and 
HHAs have sufficient time to prepare for implementation. CMS will make 
training available to HHAs on the changes to the OASIS, consistent with 
education and training resources for previous revisions to the OASIS 
instrument. CMS acknowledges that revisions to the OASIS require time 
and effort and resources for providers to prepare for the changes and 
is committed to proposing revisions to the OASIS no more frequently 
than every two years. CMS agrees that patients' needs should be 
addressed by the HHA, consistent with applicable rules and regulations, 
although we note that the proposal does not specify a requirement for 
how HHAs may address patients' needs.
    Commenters that did not support the proposal acknowledged that SDOH 
information is important but adding four data elements to the OASIS and 
modifying a fifth would be burdensome. One commenter noted that 
revisions to the OASIS are too frequent and recommended that CMS limit 
revisions to intervals of no less than four years. One commenter 
suggested that the proposed living situation data element is 
duplicative of information that is already collected and recommended 
that the look-back for the utilities data element be changed from 12 
months to three to capture more reliable, valid, and timely 
information. Another commenter encouraged CMS to consider using SDOH 
information as part of the risk-adjusted outcome quality measures. A 
commenter stated the proposal is not aligned with health-related social 
needs reporting requirements across the care continuum and that further 
testing and refinement are needed to ensure the proposed items work as 
intended in this setting. This commenter noted that CMS' evaluation of 
the AHC HRNS screening tool in the AHC Model showed that screening did 
not appear to increase beneficiary connection to community resources or 
health-related social need resolution, and they recommended CMS conduct 
further testing and developing clearer implementation guidance before 
adopting the proposed data elements in the HHQRP.
    Response: We acknowledge the commenters' concerns and appreciate 
their suggestions. As previously stated, CMS acknowledges that 
revisions to the OASIS require time and effort and resources for 
providers to prepare for the changes and we are committed to proposing 
revisions to the OASIS no more frequently than every two years. CMS 
disagrees that the proposed Living Situation data element is 
duplicative of information that is already collected because it 
addresses housing insecurity, which is not part of the information 
captured in the current OASIS. CMS

[[Page 88442]]

believes that the proposed data elements are not setting-specific, and 
that the testing conducted in their development has been sufficiently 
rigorous that we can adopt the data elements into the OASIS and the 
other PAC instruments with confidence.
    After consideration of the public comments we received, we are 
finalizing our proposal to adopt four new items as standardized patient 
assessment data elements in the SDOH category: one living situation 
item, two food items, and one utilities item, and to modify the 
``Transportation'' item in section III.D.5. of this rule beginning 
January 1, 2027, with the CY 2027 HH QRP.

G. HH QRP Quality Measure Concepts Under Consideration for Future 
Years--Request for Information (RFI)

    We sought input on the importance, relevance, appropriateness, and 
applicability of each of the following concepts under consideration for 
future years in the HH QRP: vaccinations, depression, pain management, 
and substance use disorders. In the CY 2024 HH PPS proposed rule (88FR 
43738 through 43740), we published a request for information (RFI) (CY 
2024 RFI) on a set of principles for selecting and prioritizing HH QRP 
measures, identifying measurement gaps, and suitable measures for 
filling these gaps. Within this rule, we also sought input on data 
available to develop measures, approaches for data collection, 
perceived challenges or barriers, and approaches for addressing 
identified challenges. We refer readers to the CY 2024 HH PPS final 
rule (88 FR 77772 through 77774) for a summary of the public comments 
we received in response to the RFI.
    Subsequently, our measure development contractor convened a TEP on 
December 15, 2023, to obtain input on the future measure concepts that 
could fill the measurement gaps identified in our CY 2024 RFI.\76\ The 
TEP discussed the alignment of PAC and Hospice measures with CMS' 
``Universal Foundation'' of quality measures.\77\ The Universal 
Foundation aims to focus provider attention, reduce burden, identify 
disparities in care, prioritize development of interoperable, digital 
quality measures, allow for comparisons across programs, and help 
identify measurement gaps.
---------------------------------------------------------------------------

    \76\ The Post-Acute Care (PAC) and Hospice Quality Reporting 
Program Cross-Setting TEP summary report will be published in early 
summer or as soon as technically feasible. IRFs can monitor the 
Partnership for Quality Measurement website at https://mmshub.cms.gov/get-involved/technical-expert-panel/updates for 
updates.
    \77\ Centers for Medicare & Medicaid Services. Aligning Quality 
Measures Across CMS--the Universal Foundation. November 17, 2023. 
https://www.cms.gov/aligning-quality-measures-across-cms-universal-foundation.
---------------------------------------------------------------------------

    In consideration of the feedback, we received from interested 
parties through these activities, we are seeking input on four concepts 
for the HH QRP. One is a composite of vaccinations,\78\ which could 
represent overall immunization status of patients such as the Adult 
Immunization Status measure \79\ in the Universal Foundation. A second 
concept on which we sought feedback is the concept of depression for 
the HH QRP, similar to the Clinical Screening for Depression and 
Follow-up measure \80\ in the Universal Foundation. Third, we sought 
feedback on the concept of pain management. Finally, we seek input on a 
measure concept relating to substance use disorders, such as the 
Initiation and Engagement of Substance Use Disorder Treatment measure 
\81\ included in the Universal Foundation of Quality Measures.
---------------------------------------------------------------------------

    \78\ A composite measure can summarize multiple measures through 
the use of one value or piece of information. More information can 
be found at https://www.cms.gov/medicare/quality-initiatives-patient-assessment-instruments/mms/downloads/composite-measures.pdf.
    \79\ CMS Measures Inventory Tool. Adult immunization status 
measure found at https://cmit.cms.gov/cmit/#/FamilyView?familyId=26.
    \80\ Preventative Care and Screening: Screening for Depression 
and Follow Up measure found at https://qpp.cms.gov/docs/QPP_quality_measure_specifications/CQM-Measures/2023_Measure_134_MIPSCQM.pdf.
    \81\ Initiation and Engagement of Substance Use Disorder 
Treatment measure found at https://ecqi.healthit.gov/ecqm/ec/2023/cms0137v11.
---------------------------------------------------------------------------

    While we will not be responding to specific comments in response to 
the RFI in this final rule, we invited public comment on these four 
measure concepts and intend to use this input to inform future measure 
development efforts.
1. Composite Vaccination Concept
    Some commenters supported a composite vaccination measure concept, 
while most commenters did not support this concept. Commenters in 
support of this measure concept noted that the measure would support 
increased immunization rates. One commenter noted that a composite 
vaccination measure would help bring vaccinations to homebound 
individuals, reducing access barriers, and may encourage home health 
agencies to have conversations with vaccine-skeptical individuals to 
share the benefits of vaccinations in general or one specific 
vaccination. This commenter went on to suggest that a focus on overall 
vaccination status is necessary for beneficiaries who may have long 
term health needs, chronic conditions and vulnerability to infection 
and disease. Lastly, the commenter suggested that a holistic approach 
is more equitable in that it can ensure individuals from all 
backgrounds are more likely to get a comprehensive set of vaccines. 
Several commenters expressed concerns about a composite vaccination 
concept, despite supporting this as a measure concept. One suggested 
that CMS revise the way rates are measured and reported so that, for 
example, a percentage of beneficiaries who are offered a vaccination 
does not convey a false impression of success. Another commenter 
suggested that CMS should ensure vaccines and combination products are 
accessible to providers and beneficiaries, and noted that home health 
agencies may have issues finding information on beneficiary vaccination 
status, nurses may not have time to administer vaccines, vaccines are 
costly to home health agencies, and that transport of vaccines 
requiring cold-chain and storage may present operational problems for 
home health staff who must spend hours a day on the road. Among the 
commenters that did not support a composite vaccination concept, most 
shared additional details. Most noted that such a measure would be 
burdensome to home health agencies because patient recall may be 
unreliable, so the home health agencies who do not have ready access to 
information about patients' vaccination status would have to conduct 
extensive review of patient's medical records to find this information. 
Some commenters referred to the December 2023 Post-Acute Care (PAC) and 
Hospice Quality Reporting Program Technical Expert Panel, noting that 
many provider participants did not support a vaccination measure 
concept. One commenter suggested patients might consider their 
vaccination status sensitive information and be hesitant to share their 
status with the home health staff. One commenter noted multiple issues 
home health agencies might encounter in implementation of such a 
measure including the expense of vaccines, and of ensuring safe 
vaccination of homebound patients, and the expense of controls and 
equipment needed to maintain compliance with controlled temperature 
chains required for vaccines, and that once a vial is opened the entire 
vial needs to be used in a specified short time frame that home health 
providers may not be able to achieve, thus wasting multiple doses. A 
final concern this commenter expressed was that providers who served 
populations who believe in

[[Page 88443]]

vaccination would have an advantage over providers who serve 
populations with vaccine hesitancy.
2. Depression Concept
    The majority of commenters supported the depression measure 
concept, with one commenter noting that home health already collects 
this data, and another commenter noting that patients who need home 
healthcare may be more likely to develop depression due to their 
diagnoses, chronic pain or lack of independence, and that identifying 
risk early and implementing interventions can improve patient outcomes 
and quality of life. A commenter noted that depression can affect 
patients' ability to care for themselves and provided the example of 
evidence-based occupational therapy interventions to directly impact 
depression such as engaging patients in activities that promote 
participation in everyday life, which can help build resilience, 
positive psychological and social functioning and the ability to adapt 
to change and cope with life challenges.
    Some commenters did not support the measure concept for depression. 
One commenter noted that home health clinicians already complete the 
Patient Health Questionnaire--9 (PHQ-9) and are responsible for follow-
up with the provider for patients that screen positive. Several 
commenters pointed out that home health agencies are limited in options 
or are not set up to address depression. A few commenters noted in 
addition that significant resources and infrastructure would be 
required for home health agencies to address depression, and that home 
health patients are often discharged before any outcomes from community 
referrals can be realized. These commenters also suggested that home 
health would be limited to a referral to the patient's primary care 
physician for further interventions, noting that home health agencies 
cannot be expected to provide interventions aimed at directly treating 
depression, such as pharmacological interventions or other follow-up 
that involves long-term planning.
3. Pain Management Concept
    Comments in support of a pain management measure concept mentioned 
the relevance of pain management for home health, and the impact pain 
has on all aspects of patients' lives. Several commenters noted that 
CMS retired a pain management measure from the HHQRP in 2020 due to the 
opioid crisis and suggested that, given this context, clarification 
about the intent of reintroducing this type of measure would be 
helpful.
4. Substance Use Disorders Concept
    Some commenters expressed support for the substance use disorder 
(SUD) measure concept, while most did not support this concept. One 
commenter shared that their home health agency has been seeing more 
patients with this condition, noting that generally this population is 
rejected by home health agencies due to increased risk of 
hospitalization and the tendency not to make progress quickly. The 
commenter encouraged CMS to explore collection of SUD information and 
use of this information for risk-adjusted payments that would support 
additional home health resources. Most commenters did not support the 
SUD concept, with most of those who do not support going on to note 
that management of SUD disorders is out of scope for home health or 
that home health agencies are not set up to manage SUD, which requires 
specially trained clinicians. One of these commenters noted that 
because there is no data source currently available, adding a SUD 
measure would add burden to home health agencies.
    Response: We appreciate the input provided by commenters. While we 
will not be responding to specific comments submitted in response to 
the RFI in this final rule, we intend to use this input to inform 
future measure development efforts.

IV. The Expanded Home Health Value-Based Purchasing (HHVBP) Model

A. Background

    As authorized by section 1115A of the Act and finalized in the CY 
2016 HH PPS final rule (80 FR 68624), the Center for Medicare and 
Medicaid Innovation (Innovation Center) implemented the Home Health 
Value-Based Purchasing (HHVBP) Model (``original Model'') in nine 
states on January 1, 2016. The design of the original HHVBP Model 
leveraged the successes and lessons learned from other CMS value-based 
purchasing programs and demonstrations to shift from volume-based 
payments to a model designed to promote the delivery of higher quality 
care to Medicare beneficiaries. The specific goals of the original 
HHVBP Model were to--
     Provide higher incentives for better quality care with 
greater efficiency;
     Study new potential quality and efficiency measures for 
appropriateness in the home health setting; and
     Enhance the current public reporting process.
    The original HHVBP Model resulted in an average 4.6 percent 
improvement in HHAs' total performance scores (TPS) and an average 
annual savings of $141 million to Medicare without evidence of adverse 
risks.\82\ The evaluation of the original Model also found reductions 
in unplanned acute care hospitalizations and skilled nursing facility 
(SNF) stays, resulting in reductions in inpatient and SNF spending. The 
U.S. Secretary of Health and Human Services determined that expansion 
of the original HHVBP Model will further reduce Medicare spending and 
improve the quality of care. In October 2020, the CMS Chief Actuary 
certified that expansion of the HHVBP Model will produce Medicare 
savings if expanded to all States.\83\
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    \82\ https://innovation.cms.gov/data-and-reports/2020/hhvbp-thirdann-rpt.
    \83\ https://www.cms.gov/files/document/certificationhome-health-value-based-purchasing-hhvbpmodel.pdf.
---------------------------------------------------------------------------

    On January 8, 2021, CMS announced the certification of the HHVBP 
Model for expansion nationwide, as well as the intent to expand the 
Model through notice and comment rulemaking.\84\
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    \84\ https://www.cms.gov/newsroom/press-releases/cms-takes-action-improve-home-health-care-seniors-announces-intent-expand-home-health-value-based.
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    In the CY 2022 HH PPS final rule (86 FR 62292 through 62336), we 
finalized the decision to expand the HHVBP Model to all Medicare 
certified HHAs in the 50 States, territories, and District of Columbia 
beginning January 1, 2022. CY 2022 was a pre-implementation year. The 
first payment year is CY 2025 based on the first performance year which 
was CY 2023. Our codified policies for the expanded HHVBP Model can be 
found in our regulations at 42 CFR part 484, subpart F, Sec. Sec.  
484.300 through 484.375.

B. Request for Information on Future Performance Measure Concepts for 
the Expanded HHVBP Model

    The expanded HHVBP Model provides an opportunity to examine a broad 
array of quality measures that address critical gaps in care. A 
comprehensive review of the Value-Based Purchasing (VBP) experience, 
conducted by the Office of the Assistant Secretary for Planning and 
Evaluation (ASPE), identified several objectives for HHVBP 
measures.\85\ The recommended objectives emphasize measuring patient 
outcomes and functional status; appropriateness of care; and incentives 
for providers to build infrastructure to

[[Page 88444]]

facilitate measurement within the quality framework. The study 
identified the following seven objectives which served as guiding 
principles for the development of performance measures used in the 
original HHVBP Model:
---------------------------------------------------------------------------

    \85\ U.S. Department of Health and Human Services. Office of the 
Assistant Secretary for Planning and Evaluation (ASPE) (2014). 
Measuring Success in Health Care Value-Based Purchasing Programs. 
Cheryl L. Damberg et al. on behalf of RAND Health.
---------------------------------------------------------------------------

     Use a broad measure set that captures the complexity of 
the HHA service provided.
     Incorporate the flexibility to include Improving Medicare 
Post-Acute Care Transformation (IMPACT) Act of 2014 measures that are 
cross-cutting amongst post-acute care settings.
     Develop second-generation measures of patient outcomes, 
health and functional status, shared decision making, and patient 
activation.
     Include a balance of process, outcome, and patient 
experience measures.
     Advance the ability to measure cost and value.
     Add measures for appropriateness or overuse.
     Promote infrastructure investments.
    A central driver of the process used to select measures for the 
original HHVBP Model was incorporating innovative thinking from the 
field while simultaneously drawing on evidence-based literature and 
documented best practices. Broadly, measures were selected based on 
their impact on care delivery and to support the goal of improving 
health outcomes, quality, safety, efficiency, and experience of care 
for patients.
    As we continue to leverage our value-based purchasing initiatives 
to improve the quality of care furnished across healthcare settings, we 
are interested in considering new performance measures for inclusion in 
the expanded HHVBP Model. We specifically request public comments on 
several specific performance measures as well as general comments on 
other future model concepts that may be considered for inclusion in the 
expanded HHVBP Model. These measures are based on input from the HHVBP 
Technical Expert Panel (TEP), which met in Fall 2023. The TEP included 
experts from the home health setting specializing in quality assurance, 
patient advocacy, clinical work, and measure development. The meeting 
included a discussion of potential measures for inclusion in the 
expanded HHVBP Model. These include a combination of new measure 
concepts (for example, family caregiver measure), already developed 
measures that are not currently in the measure set for the expanded 
HHVBP Model (for example, Medicare Spending per Beneficiary (MSPB)), 
and new OASIS-based and claims-based measures.
     Family caregiver measure: Generally, TEP members were very 
supportive of future development of a family caregiver measure. One TEP 
member encouraged CMS to ``think outside the box'' to find ways of 
including the caregiver's voice in quality reporting. The TEP discussed 
OASIS items that provide information related to the patient's caregiver 
status. While acknowledging that the focus of the Medicare home health 
benefit is the patient, not the caregiver, they recommended that CMS 
consider the caregiver as a partner and measure caregivers' needs and 
not just the needs as they relate to the beneficiary. The TEP noted 
that the caregivers are often the reason patients are even able to be 
at home (vs. receiving care in the more costly nursing home setting). 
CMS intends to develop a patient-reported outcome performance measure 
(PRO-PM) to assess caregiver burden in the Guiding an Improved Dementia 
Experience (GUIDE) Model that may be a useful example for caregiver 
measures that may be developed for HHVBP.\86\ Creating one or more 
measures based on an HHA's ability to meet caregiver needs will permit 
measurement of changes in caregiver quality-of-life.
---------------------------------------------------------------------------

    \86\ For more details on the GUIDE Model, see the Model web page 
(https://www.cms.gov/priorities/innovation/innovation-models/guide). 
For more details on the caregiver measures being developed for 
GUIDE, see the Request for Applications (https://www.cms.gov/files/document/guide-rfa.pdf).
---------------------------------------------------------------------------

     Falls with major injury (claims-based): Several TEP 
members suggested that CMS explore a claims-based measure of falls with 
major injury. One TEP member noted an Office of Inspector General (OIG) 
study that found that HHAs failed to report 55 percent of falls leading 
to major injuries and hospitalizations on their OASIS data.\87\ While 
it may not be possible to identify all falls from claims data, a 
claims-based measure may be more accurate, although, as with other 
claims-based measures, data will only be available for Fee for Service 
patients. Due to the high rate of non-reporting, the OASIS-based falls 
measure may not provide accurate information about the incidence of 
these falls.
---------------------------------------------------------------------------

    \87\ https://oig.hhs.gov/oei/reports/OEI-05-22-00290.asp.
---------------------------------------------------------------------------

     Medicare Spending per Beneficiary (MSPB): The TEP also 
discussed potentially adding the MSPB measure to the HHVBP applicable 
measure set. This cross-setting measure is part of the Home Health 
Quality Reporting Program and is currently publicly reported on Care 
Compare. MSPB may be a valid tool for measuring the value of the care 
that HHAs provide that may be appropriate for use in the expanded HHVBP 
Model. The measure will provide information on the efficiency of home 
health providers, as measured by Medicare payments for their patients.
     Function measures to complement existing cross-setting 
Discharge (DC) function measure: Several TEP members raised a concern 
that the measure does not include the full self-care/activities of 
daily living elements (for example, bathing, dressing), which they 
noted as critically important for home health patients and caregivers. 
Another TEP member indicated that patients often already have capacity 
to do things like roll and sit up when they enter home health care but 
may not be able to bathe or get dressed without assistance. The TEP 
emphasized the importance of functional cognition, which is included in 
OASIS item GG0100 as part of prior functional status but is not 
included as part of the current DC function measure.
    As we continue to explore refinements to the expanded HHVBP Model, 
we requested comments related to adding the potential performance 
measures described previously to the HHVBP Measure Set. We also 
requested comments about other potential performance measures that we 
should consider for the expanded HHVBP Model.
    We received the following comments:
    Comments: We received generally positive stakeholder reaction to 
the request for information on future measure concepts for the expanded 
HHVBP Model. Commenters also expressed concerns about each of the 
potential measures.
    Commenters were generally supportive of the caregiver burden 
assessment measure concept, but expressed concerns about how to 
accurately identify caregivers, how the data would be utilized, and 
whether the data would be used to determine home care eligibility.
    Commenters generally supported the proposed measures to complement 
the DC function measure, particularly focusing on self-care/ADL 
measures. Commenters suggested that CMS consider using only one set of 
assessment items to measure function, as using a single set of function 
items would allow HHAs to focus on coding accuracy and avoid the 
confusion associated with multiple assessment categories.
    The MSPB measure received mixed comments. Supporters of this 
measure believe that it provides information on the efficiency of home 
health providers and would help identify the costs associated with the 
delivery of high-

[[Page 88445]]

quality nursing services. Comments that were critical of the measure 
stated that the measure's focus on spending rather than quality could 
create incentives to omit needed care services.
    The falls with major injury measure received mixed comments. Some 
commenters noted that it is claims-based but noted that the measure 
includes only Medicare fee-for-service (FFS) patients. Others stated 
that falls are outside of a home health agency's control given that 
home health services are provided on an intermittent basis.
    Some commenters offered suggestions for other possible measures to 
include in the expanded HHVBP Model, including advance care planning, 
access to palliative care services, timely and appropriate referral to 
hospice, interoperability, the average time between referral and 
initiation of care, follow-up care coordination, and meaningful 
measures for patients with chronic conditions that are not expected to 
improve.
    Some commenters expressed concerns about burden and duplicative 
reporting with the QRP measures. One commenter suggested that CMS 
transition to using data sources that are not easily manipulated, such 
as claims data and patient experience responses instead of OASIS-based 
measures.
    Response: We appreciate the comments that we received on the 
request for information. We are not responding to individual specific 
comments submitted in response to the RFI in this final rule, but these 
comments will be reviewed with stakeholders and the HHVBP TEP that 
provide input when considering changes to the HHVBP applicable measure 
set. Any changes to the applicable measure set will be made through 
future rulemaking.

C. Future Approaches to Health Equity in the Expanded HHVBP Model

    In alignment with the President's Executive orders \88\ to support 
underserved communities, CMS is working to advance health equity by 
designing, implementing, and operationalizing policies and programs 
that support health for all the people served by our programs, 
eliminating avoidable differences in health outcomes experienced by 
people who are disadvantaged or underserved, and providing the care and 
support that our enrollees need to thrive. As we continue to leverage 
our value-based purchasing initiatives to improve the quality of care 
furnished across healthcare settings, we are interested in exploring 
the role of health equity in creating better health outcomes for all 
populations in our programs and models. In the CY 2023 HH PPS final 
rule, we stated that we are committed to achieving equity in health 
care outcomes for beneficiaries by supporting providers in quality 
improvement activities to reduce health disparities, enabling 
beneficiaries to make more informed decisions, and promoting provider 
accountability for health care disparities.\89\
---------------------------------------------------------------------------

    \88\ Executive Orders 13985, ``Advancing Racial Equity and 
Support for Underserved Communities Through the Federal 
Government,'' and 14091, ``Executive Order on Further Advancing 
Racial Equity and Support for Underserved Communities Through The 
Federal Government.''
    \89\ https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/Downloads/CMS-Quality-Strategy.pdf.
---------------------------------------------------------------------------

    The CY 2023 HH PPS rule (87 FR 66874 through 66876) included an 
RFI, ``Future Approaches to Health Equity in the expanded HHVBP 
Model.'' The RFI requested feedback on policy changes that we should 
consider on the topic of health equity and specific actions the 
expanded HHVBP Model should take to address healthcare disparities and 
advance health equity. We specifically requested comments on whether we 
should consider incorporating adjustments into the expanded HHVBP Model 
to reflect the varied patient populations that HHAs serve around the 
country and tie health equity outcomes to the payment adjustments we 
make based on HHA performance under the Model. One possible approach is 
to make adjustments at the measure level such as stratification by 
which additional points are provided to HHAs that provide care to 
underserved communities (for example, based on dual status or other 
metrics).\90\ Payment adjustments could also be incorporated at the 
scoring level in forms such as modified benchmarks, points adjustments, 
or modified payment adjustment percentages (for example, peer 
comparison groups based on whether the HHA includes a high proportion 
of dual eligible beneficiaries). We requested commenters' views on 
which of these adjustments, if any, will be most effective for the 
expanded HHVBP Model. Commenters shared that relevant data collection 
and appropriate stratification are very important in addressing any 
health equity gaps. While not suggesting specific approaches, these 
commenters noted that CMS should consider potential stratification of 
health outcomes. Stakeholders, including providers, also shared their 
strategies for addressing health disparities, noting that this was an 
important commitment for many health provider organizations.
---------------------------------------------------------------------------

    \90\ CMS defines an ``underserved community'' as ``individuals 
who share a particular characteristic--demographic, geographic 
(urban or rural), or other factor--that results in them being 
systemically denied full opportunity to participate in aspects of 
economic, social, and civic life. (Source: https://www.cms.gov/priorities/innovation/key-concepts/health-equity)
---------------------------------------------------------------------------

    Several previous studies have found that historically underserved 
communities, including Medicare beneficiaries who are dually enrolled 
in Medicaid, live in a low-income neighborhood, or are Black, receive 
lower quality home health care relative to communities not historically 
underserved.\91\ Previous studies have found that patients from 
underserved communities have higher rates of hospital readmissions, are 
more likely to be discharged without functional improvement,\92\ are 
less likely to receive care from high-quality HHAs, and have worse 
patient-reported care experiences. Improving the quality of care for 
these underserved communities is an important quality improvement goal 
under the expanded HHVBP Model.
---------------------------------------------------------------------------

    \91\ Joynt Maddox, K.E., Chen, L.M., Zuckerman, R., & Epstein, 
A.M. (2018). Association Between Race, Neighborhood, and Medicaid 
Enrollment and Outcomes in Medicare Home Health Care. Journal of the 
American Geriatrics Society, 66(2), 239-246. https://doi.org/10.1111/jgs.15082.
    \92\ Fashaw-Walters, S.A., Rahman, M., Jarr[iacute]n, O.F., Gee, 
G., Mor, V., Nkimbeng, M., & Thomas, K.S. (2023). Getting to the 
root: Examining within and between home health agency inequities in 
functional improvement. Health Services Research. https://doi.org/10.1111/1475-6773.14194.
---------------------------------------------------------------------------

    Disparities in health care outcomes may result from differences 
within HHAs (for example, patients from underserved communities within 
certain HHAs service areas are less likely to have good outcomes, such 
as functional improvement, discharge to community, and avoiding 
readmission to a hospital). These disparities may also result from 
differences across HHAs. That is, patients from underserved communities 
are less likely than other patients to receive care from good quality 
HHAs and thus at higher risk of poor outcomes.\93\ The literature is 
mixed on the sources of these disparities. One study found that 
differences in readmission rates for underserved communities were 
primarily within, rather than across, HHAs.\94\ Another study found 
that

[[Page 88446]]

differences both within and across HHAs contribute to the overall 
disparities in patients' functional improvement.\95\ This same study 
found that roughly half of observed individual-level disparities in the 
use of high-quality home health agencies was attributable to 
neighborhood-level factors.\96\ Differences in care experience for 
underserved communities were explained by differences both within and 
across HHAs, but the within-HHA variations more often accounted for a 
greater proportion of the differences.\97\
---------------------------------------------------------------------------

    \93\ Fashaw-Walters, S.A., Rahman, M., Gee, G., Mor, V., White, 
M., & Thomas, K.S. (2022). Out Of Reach: Inequities in the Use of 
High-Quality Home Health Agencies. Health Affairs (Project Hope), 
41(2), 247-255. https://doi.org/10.1377/hlthaff.2021.01408.
    \94\ Joynt Maddox, K.E., Chen, L.M., Zuckerman, R., & Epstein, 
A.M. (2018). Association Between Race, Neighborhood, and Medicaid 
Enrollment and Outcomes in Medicare Home Health Care. Journal of the 
American Geriatrics Society, 66(2), 239-246. https://doi.org/10.1111/jgs.15082.
    \95\ Fashaw-Walters, S.A., Rahman, M., Jarr[iacute]n, O.F., Gee, 
G., Mor, V., Nkimbeng, M., & Thomas, K.S. (2023). Getting to the 
root: Examining within and between home health agency inequities in 
functional improvement. Health Services Research. https://doi.org/10.1111/1475-6773.14194.
    \96\ Fashaw-Walters SA, Rahman M, Gee G, Mor V, White M, Thomas 
KS. Out Of Reach: Inequities In The Use Of High-Quality Home Health 
Agencies. Health Aff (Millwood). 2022 Feb;41(2):247-255. doi: 
10.1377/hlthaff.2021.01408. PMID: 35130066; PMCID: PMC8883595.
    \97\ Joynt Maddox, K.E., Chen, L.M., Zuckerman, R. and Epstein, 
A.M. (2018), Association Between Race, Neighborhood, and Medicaid 
Enrollment and Outcomes in Medicare Home Health Care. J Am Geriatr 
Soc, 66: 239-246. https://doi.org/10.1111/jgs.15082.
---------------------------------------------------------------------------

    We have been exploring several potential approaches for integrating 
health equity concepts into the expanded HHVBP Model. Considerations 
for evaluating these approaches include the following:
     Effectiveness: Does the approach further the model test? 
What will its impact on underserved communities be?
     Feasibility: How long will it take to implement the 
approach? Are the necessary data currently being collected? How many 
HHAs will be included?
     Reliability: Does the approach allow for reliable 
measurement of health equity within HHAs?
     Alignment: Is this approach aligned with other Medicare 
quality and VBP Programs?

D. Social Risk Factors

    As part of our work developing potential equity measures, we are 
exploring potential definitions to use for defining historically 
underserved communities. Building on feedback from other VBP proposals, 
our analyses have focused on three potential social risk factors dual 
eligible status (DES), Area Deprivation Index (ADI), and Medicaid as 
sole payment source that can serve as a proxy to identify the 
underserved. Note that we also examined low-income subsidy (LIS) as a 
potential measure of equity but did not include it in further analyses, 
because the correlation for the DES proportion and the LIS eligibility 
proportion is above 0.98. We also plan to assess disparities between 
rural and urban home health providers and patients when analyzing 
social risk factors, perhaps measuring rurality using the rural-urban 
commuting area (RUCA) codes, which classify U.S. census tracts using 
measures of population density, urbanization, and daily commuting.

E. Approaches to a Potential Health Equity Adjustment for the Expanded 
HHVBP Model

    One of the approaches that we have explored is the Health Equity 
Adjustment (HEA) that will begin in the Skilled Nursing Facility (SNF) 
VBP starting with the FY 2027 program year. The HEA is calculated using 
a methodology that considers a SNF's performance on the SNF VBP quality 
measures and the proportion of the SNF's residents with DES. Under the 
HEA, SNFs that perform well on the SNF VBP quality measures and serve a 
higher proportion of residents with DES will earn HEA bonus points are 
added to normalized sum of all points a SNF is awarded for each 
measure. That sum is then the final SNF Performance Score. More 
information on the HEA can be found in the FY 2024 SNF PPS final rule 
(88 FR 53304).
    We used the HEA methodology that was finalized for the SNF VBP to 
simulate how that methodology will impact the expanded HHVBP Model, 
using the current measure set for the Model and July 2023 Interim 
Performance Report (IPR) data. A limitation of using the July 2023 IPR 
data for these analyses is that the TPS for the July 2023 IPRs was 
mainly based on achievement points--there are no improvement points for 
the claims-based and HHCAHPS measures (due to lags in the data for 
these measures) and only small improvement points for the OASIS-based 
measures. This may distort results of the equity implications of the 
HEA methodology, but we believe that using the more current data is 
preferable to using earlier data from prior to the public health 
emergency. We used data on the proportion of HHA patients who are 
dually eligible at any point during the performance year. The HEA 
methodology is fully described in the FY 2024 Skilled Nursing Facility 
Prospective Payment System final rule (88 FR 53307 through 53316) that 
included--
     Determine number of measures for which HHA is a top tier 
performer;
     Calculate measure performance scaler;
     Calculate underserved multiplier;
     Calculate HEA Bonus Points; and,
     Add HEA Bonus Points to the Normalized Sum of all Points 
Awarded for Each Measure.
    Using the original TPS and a TPS measure that includes the HEA 
bonus points), we simulated payment adjustment amounts with and without 
the HEA. We examined the change in payment adjustment percentage for 
HHAs based on their dual eligibility status (for example, decile in 
terms of percentage of dual eligible patients) and HEA bonus points.
    Of the 10,218 active HHAs in the July 2023 quarterly monitoring 
analytic file, 9,591 (93.9 percent) have information on the number of 
beneficiaries with dual eligible status (DES) that were served by the 
HHA in the performance year. Of these HHAs, a TPS was calculated for 
7,556. Because the HEA operates by adding points to the TPS, it is only 
possible to calculate a TPS including the HEA for these 7,556 HHAs that 
had a valid TPS.
    We found that the average TPS was higher for HHAs in the highest 
decile in terms of share of beneficiaries with DES than for HHAs in any 
other decile, before applying the HEA. Applying the HEA primarily 
increased TPS for these HHAs that were already high performing, which 
increased the gap in the average payment adjustment for these HHAs and 
the average payment adjustment for HHAs serving a lower share of 
beneficiaries with DES. As a result, we concluded that the HEA using 
DES as the proxy for the underserved, as designed for SNF VBP, may not 
the best approach for the home health setting. In contrast, the average 
TPS was higher for HHAs with a relatively low share of beneficiaries 
living in a neighborhood with a high ADI.
    We also plan to consider how changes to the definition of the 
underserved population, as codified in the SNF VBP regulatory text at 
Sec.  413.338(a) will alter the effects of the HEA. In contrast to the 
results for dual eligibility, we have found that average TPS was lower 
for HHAs serving a high share of beneficiaries living in a neighborhood 
with a high ADI. We also found that HHAs in the highest ADI quintile 
and highest DES quintile had lower average TPS than other groups. These 
results suggest that defining the underserved population using ADI or a 
combination of ADI and DES will alter the effects of the HEA. We are 
also examining measures of the underserved population that are based on 
the percentage of patients with Medicaid as the only payment source.

[[Page 88447]]

F. Other Health Equity Measures

    We are also exploring other health equity measures that will more 
directly focus on certain disparities. These could be structured in 
several different ways:
     Measure(s) for particular underserved communities: 
Performance on one or more measures for specific underserved 
communities (for example, based on DES).
     Measure(s) based on within-provider differences in 
performance for underserved communities (for example, based on DES): 
This type of measure could be based on a single outcome or multiple 
outcomes (that is, a composite measure).
     Measure(s) based on the worst performing group: Calculate 
performance scores for multiple patient groups and set the measure 
performance equal to the score for the worst performing group.
    We have examined the reportability of these other health equity 
measures and have found that several HHAs will not have a sufficient 
number of DES beneficiaries for these measures to be calculated. Our 
analyses of data used for the July 2023 IPRs found that, overall, 25.4 
percent of HHAs served fewer than 12 beneficiaries with DES. This 
suggests that roughly one-fourth of HHAs may not serve enough 
beneficiaries with DES to calculate a performance measure using only 
beneficiaries with DES. The percentage of HHAs that served fewer than 
12 beneficiaries with DES or fewer than 12 beneficiaries without DES 
was 36.5 percent. Although the reportability for these measures do 
exclude some smaller HHAs that serve fewer underserved patients, the 
reportability level will be closely aligned to the current SNF VBP HEA. 
As the 25.4 percent proportion that are not reported is not that much 
more than is currently being excluded on the SNF VBP HEA where SNFs in 
the bottom 20 percent of proportion duals are excluded. The impact or 
reportability of a potential HHVBP HEA needs more analysis for future 
consideration.
    Looking forward, we recognize that the exact structure of the 
current SNF VBP HEA may not be the most efficient approach for the 
unique attributes of care being provided in the home versus care in the 
SNF. However, CMS is committed to and working towards the establishment 
of an HHVBP HEA that rewards HHAs that provide high quality care to 
underserved communities. We will continue to explore the addition of 
other measures, using other proxies for identifying the underserved and 
possibly adjusting the scoring mechanism to be more effective at 
addressing the issue.
    As a reminder, we stated in the CY 2024 HH PPS final rule (88 FR 
77790), we will gather at least 2 years of performance data, and study 
effects of the expanded Model on health equity outcomes before 
incorporating any potential changes to the expanded Model regarding 
health equity.
    We received the following comments:
    Comments: Commenters supported our efforts to advance health equity 
within the expanded HHVBP Model. Additionally, commenters provided 
specific comments, concerns, and requests related to the expanded HHVBP 
Model falling into the following themes:
    While most commenters were supportive of efforts to incorporate 
health equity into the expanded HHVBP Model, some of the supportive 
comments also expressed concerns about implementation issues including 
provider burden of reporting requirements for equity measures. Some 
commenters expressly supported the adoption of the Health Equity 
Adjustment (HEA) used in the SNF VBP Program in the expanded HHVBP 
Model. Other commenters expressed concern that the expanded HHVBP Model 
may exacerbate HHAs' disincentives to treat some patients. One 
commenter suggested that we consider ways to incentivize agencies who 
care for underserved communities and/or chronically complex patients.
    Response: We appreciate the comments that we received and are 
taking these comments into account, as appropriate, as we continue to 
work to develop policies, quality measures, and measurement strategies 
on health equity. We plan to review these comments with the HHVBP TEP 
to provide input to inform development of health equity quality 
measures.

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

A. General Background

1. Statutory Background
    Division FF, section 4134 of the CAA, 2023 added coverage and 
payment of items and services related to administration of IVIG in a 
patient's home of a patient with a diagnosed primary immune deficiency 
disease furnished on or after January 1, 2024. Division FF, section 
4134(a) of the CAA, 2023 amended the existing IVIG benefit category at 
section 1861(s)(2)(Z) of the Act by adding coverage for IVIG 
administration items and services in a patient's home of a patient with 
a diagnosed primary immune deficiency disease. This benefit covers 
items and services related to administration of IVIG in a patient's 
home of a patient with a diagnosed primary immune deficiency disease. 
In addition, section 4134(b) of Division FF of the CAA, 2023 amended 
section 1842(o) of the Act by adding a new paragraph (8) that 
established the payment for IVIG administration items and services. 
Under the CAA, 2023 provision, payment for these IVIG administration 
items and services is required to be a bundled payment separate from 
the payment for the IVIG product, made to a supplier for all items and 
services related to administration of IVIG furnished in the home during 
a calendar day.
2. Overview
    Primary immune deficiency diseases (PIDD) are conditions triggered 
by genetic defects that cause a lack of and/or impairment in antibody 
function, resulting in the body's immune system not being able to 
function in a normal way. Immune globulin (Ig) therapy is used to 
temporarily replace some of the antibodies (that is, immunoglobulins) 
that are missing or not functioning properly in people with PIDD.\98\ 
The goal of Ig therapy is to use Ig obtained from normal donor plasma 
to maintain a sufficient level of antibodies in the blood of 
individuals with PIDD to fight off bacteria and viruses. Ig is 
formulated for both intravenous and subcutaneous administration (SCIg). 
Clinicians can prescribe either product to the beneficiary with PIDD 
according to clinical need and preference, and beneficiaries can switch 
between intravenous and subcutaneous administration of Ig.
---------------------------------------------------------------------------

    \98\ Perez EE, Orange JS, Bonilla F, et al. (2017) Update on the 
use of immunoglobulin in human disease: A review of evidence; 
Journal Allergy Clin Immunol. 139(3S): S1--S46.
---------------------------------------------------------------------------

3. Legislative Summary
    Section 642 of the Medicare Prescription Drug, Improvement, and 
Modernization Act of 2003 (Pub. L. 108-173) amended section 1861 of the 
Act to provide Medicare Part B coverage of the IVIG product for the 
treatment of PIDD in the home, but not the items and services involved 
with administration.
    Section 101 of the Medicare IVIG Access and Strengthening Medicare 
and Repaying Taxpayers Act of 2012 (Medicare IVIG Access Act) (Pub. L. 
112-242) mandated the establishment, implementation, and evaluation of 
a 3-year Medicare Intravenous Immune Globulin (IVIG) Demonstration 
Project (the Demonstration) under Part B of title

[[Page 88448]]

XVIII of the Act. The Demonstration was implemented to evaluate the 
benefits of providing coverage and payment for items and services 
needed for the home administration of IVIG for the treatment of PIDD, 
and to determine if it will improve access to home IVIG therapy for 
patients with PIDD. The Medicare IVIG Access Act mandated that Medicare 
establish a per visit payment amount for the items and services 
necessary for the home administration of IVIG therapy for beneficiaries 
with specific PIDD diagnoses. The Demonstration did not include 
Medicare payment for the IVIG product which continues to be paid under 
Part B in accordance with sections 1842(o) and 1847(A) of the Act. The 
Demonstration covered and paid a per visit payment amount for the items 
and services needed for the administration of IVIG in the home. Items 
may include infusion set and tubing, and services include nursing 
services to complete an infusion of IVIG lasting on average three to 
five hours.\99\
---------------------------------------------------------------------------

    \99\ Updated Interim Report to Congress: Evaluation of the 
Medicare Patient Intravenous Immunoglobulin Demonstration Project, 
2022: https://innovation.cms.gov/data-and-reports/2022/ivig-updatedintrtc.
---------------------------------------------------------------------------

    On September 28, 2017, Congress passed the Disaster Tax Relief and 
Airport and Airway Extension Act of 2017 (Pub. L. 115-63). Section 302 
of Pub. L. 115-63 extended the Demonstration through December 31, 2020.
    Division CC, section 104, of the Consolidated Appropriations Act, 
2021 (Pub. L. 116-260) further extended the Demonstration for another 3 
years through December 31, 2023.
    Division FF, section 4134 of the CAA, 2023 (Pub. L. 117-328) 
mandated that CMS establish permanent coverage and payment for items 
and services related to administration of IVIG in a patient's home of a 
patient with PIDD. The permanent home IVIG items and services payment 
is effective for home IVIG administration furnished on or after January 
1, 2024. Payment for these items and services is required to be a 
separate bundled payment made to a supplier for all administration 
items and services furnished in the home during a calendar day. The 
statute provides that payment amount may be based on the amount 
established under the Demonstration. The standard Part B coinsurance 
and the Part B deductible is required to apply. In addition, that 
statute states that the separate bundled payment for these IVIG 
administration items and services does not apply for individuals 
receiving services under the Medicare home health benefit. The CAA, 
2023 provision clarifies that a supplier who furnishes these services 
meet the requirements of a supplier of medical equipment and supplies.
4. Demonstration Overview
    Under the Demonstration, Medicare provided a bundled payment under 
Part B, that is separate from the IVIG product, for items and services 
that are necessary to administer IVIG in the home to enrolled 
beneficiaries who are not otherwise homebound and receiving services 
under the home health benefit. The Demonstration only applied to 
situations where the beneficiary required IVIG for the treatment of 
certain PIDD diagnoses or was receiving SCIg to treat PIDD and wished 
to switch to IVIG.
    Services covered under the Demonstration were required to be 
provided and billed by specialty pharmacies, enrolled as durable 
medical equipment (DME) suppliers, that provided the Medicare Part B-
covered Ig. The covered items and services under the Demonstration were 
paid as a single bundle and subject to coinsurance and deductible in 
the same manner as other Part B services. HHAs were not eligible to 
bill for services covered under the Demonstration but could bill for 
services related to the administration of IVIG if the patient was 
receiving services under a home health episode of care, in which case 
the home health payment covered the items and services.
    In order to participate in the Demonstration, beneficiaries must 
have met the following requirements:
     Be eligible to have the IVIG paid for at home under Part B 
FFS.
     Have a diagnosis of PIDD.
     Not be enrolled in a Medicare Advantage plan.
     Cannot be in a home health episode of care on the date of 
service (in such circumstances, the home health payment covers the 
services).
     Must receive the service in their home or a setting that 
is ``home like''.
    To participate in the Demonstration, the beneficiary was required 
to submit an application, signed by their physician.
    DME suppliers billing for the items and services covered under the 
Demonstration must have met the following requirements:
     Meet all Medicare, as well as other national, state, and 
local standards and regulations applicable to the provision of services 
related to home infusion of IVIG.
     Be enrolled and current with the National Supplier 
Clearinghouse.
     Be able to bill the DME Medicare Administrative 
Contractors (MACs).
    CMS implemented a bundled per visit payment amount under the 
Demonstration, statutorily required to be based on the national per 
visit low-utilization payment adjustment (LUPA) for skilled nursing 
services used under the Medicare HH PPS established under section 1895 
of the Act. The payment amount was subject to coinsurance and 
deductible.
    For billing under the Demonstration, CMS established a ``Q'' code 
for services, supplies, and accessories used in the home:
     Q2052--(Long Description)--Services, supplies, and 
accessories used in the home under Medicare Intravenous immune globulin 
(IVIG) Demonstration.
     Q2052--(Short Description)--IVIG demo, services/supplies.
    Suppliers billed Q2052 as a separate claim line on the same claim 
for the IVIG product.

B. Scope of Expanded IVIG Benefit

    As discussed previously, Division FF, section 4134 of the CAA, 2023 
added coverage of items and services related to the administration of 
IVIG in a patient's home, to the existing IVIG benefit category at 
section 1861(s)(2)(Z) of the Act, effective January 1, 2024. IVIG is 
covered in the home under Part B if all the following criteria are met:
     It is an approved pooled plasma derivative for the 
treatment of primary immune deficiency disease.
     The patient has a diagnosis of primary immune deficiency 
disease.
     The IVIG is administered in the home.
     The treating practitioner has determined that 
administration of the IVIG in the patient's home is medically 
appropriate.
    Therefore, as section 4134(a)(1) of the CAA, 2023 adds the items 
and services (furnished on or after January 1, 2024) related to the 
administration of IVIG to the benefit category defined under section 
1861(s)(2)(Z) of the Act (the Social Security Act provision requiring 
coverage of the IVIG product in the home), the same beneficiary 
eligibility requirements for the IVIG product apply for the IVIG 
administration items and services. Subpart B of part 410 of the 
regulations sets out the medical and other health services requirements 
under Part B. The regulations at Sec.  410.10 identify the services 
that are subject to the conditions and limitations specified in subpart 
B. Section 410.10(y) includes intravenous immune globulin administered 
in the home for the treatment of primary immune deficiency

[[Page 88449]]

diseases. Section 410.12 outlines general basic conditions and 
limitations for coverage of medical and other health services under 
Part B, as identified in Sec.  410.10. Section 410.12(a) includes the 
conditions that must be met for these services to be covered, and 
include the following:
     When the services must be furnished. The services must be 
furnished while the individual is in a period of entitlement.
     By whom the services must be furnished. The services must 
be furnished by a facility or other entity as specified in Sec. Sec.  
410.14 through 410.69.
     Physician certification and recertification requirements. 
If the services are subject to physician certification requirements, 
they must be certified as being medically necessary, and as meeting 
other applicable requirements, in accordance with subpart B of part 
424.
    As the definition of IVIG at section 1861(zz) of the Act now 
includes the items and services necessary to administer IVIG in the 
home, in the CY 2024 HH PPS final rule (88 FR 77793), we finalized the 
amendment to the regulation at Sec.  410.10(y) to add ``items and 
services''. Furthermore, sub-regulatory guidance documents (that is, 
IVIG LCD (33610) \100\ and IVIG Policy Article (A52509) \101\) provide 
direction on coding and coverage for the IVIG product at home. Through 
the Local Coverage Determination (LCD) for Intravenous Immune Globulin 
(L33610),\102\ the Durable Medical Equipment Medicare administrative 
contractors (DME MACs) specify the Healthcare Common Procedure Coding 
System (HCPCS) codes for which IVIG derivatives are covered under this 
benefit. Therefore, a beneficiary must be receiving one of the IVIG 
derivatives specified under the LCD for IVIG to qualify to receive the 
items and services covered under section 1861(s)(2)(Z) of the Act. 
Furthermore, for any item (including IVIG) to be covered by Medicare, 
it must--(1) be eligible for a defined Medicare benefit category; (2) 
be reasonable and necessary for the diagnosis or treatment of illness 
or injury or to improve the functioning of a malformed body member; and 
(3) meet all other applicable Medicare statutory and regulatory 
requirements. Policy guidance for the LCD for IVIG \103\ identifies the 
ICD-10-CM codes that support medical necessity for the provision of 
IVIG in the home. These diagnosis codes are listed in table 27.
---------------------------------------------------------------------------

    \100\ https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?LCDId=33610.
    \101\ https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=52509.
    \102\ Local Coverage Determination (LCD): IVIG (L33610) https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?LCDId=33610&ContrId=389.
    \103\ https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=52509.
[GRAPHIC] [TIFF OMITTED] TR07NO24.057

    In accordance with this guidance, a beneficiary must be diagnosed 
with one of the primary immune deficiencies identified by the ICD-10-CM 
codes, set out in table 27 and as updated in subregulatory guidance, to 
qualify to receive the items and services covered under section 
1861(s)(2)(Z) of the Act. This policy guidance is revised as

[[Page 88450]]

needed by the DME MACs. And finally, to qualify to receive IVIG in the 
home, section 1861(zz) of the Act requires that a treating practitioner 
must have determined that administration of the IVIG in the patient's 
home is medically appropriate. Accordingly, we updated the 
subregulatory guidance pursuant to the CAA, 2023 to reflect the 
expansion of the benefit to the items and services related to the home 
administration of IVIG. Leveraging the existing regulations and sub-
regulatory guidance maintains one set of standards across the entire 
IVIG benefit (that is, for the product and for the related items and 
services needed for home administration).
1. Items and Services Related to the Home Administration of IVIG
    Section 101(c) of the Medicare IVIG Access Act established coverage 
for items and services needed for the in-home administration of IVIG 
for the treatment of primary immunodeficiencies under a Medicare 
demonstration program. In the CY 2024 HH PPS final rule, we stated that 
we interpreted section 4134 of the CAA, 2023 to make permanent coverage 
of the same items and services under the existing IVIG Demonstration to 
promote continuous and comprehensive coverage for beneficiaries who 
choose to receive home IVIG therapy (88 FR 77794). Under the 
Demonstration, the bundled payment for the items and services necessary 
to administer the drug intravenously in the home included the infusion 
set and tubing, and nursing services to complete an infusion of IVIG 
lasting on average three to five hours.\104\ Although ``items and 
services'' are not explicitly defined under section 4134 of the CAA, 
2023, we stated in the CY 2024 HH PPS proposed rule (88 FR 43755) that 
we believed the items and services covered under the Demonstration are 
inherently the same items and services that will be covered under the 
payment added to the benefit category at section 1861(s)(2)(Z) of the 
Act. We also did not enumerate a list of services that must be included 
in the separate bundled payment; however, we stated that we anticipated 
the nursing services will include such professional services as IVIG 
administration, assessment and site care, and education (88 FR 43755). 
Moreover, we stated that it is up to the provider to determine the 
services and supplies that are appropriate and necessary to administer 
the IVIG for each individual, and this may or may not include the use 
of a pump. Because IVIG does not have to be administered through a pump 
(although it can be), external infusion pumps are not covered under the 
DME benefit for the administration of IVIG. An external infusion pump 
is only covered under the DME benefit if the infusion pump is necessary 
to safely administer the drug. The Local Coverage Determination (LCD) 
for External Infusion Pumps identify the drugs and biologicals that the 
DME Medicare Administrative Contractors (MACs) have determined require 
the use of such pumps and cannot be administered via a disposable 
elastomeric pump or the gravity drip method.\105\ As such, under the 
IVIG Demonstration, coverage did not extend to the DME pump, and 
thereby, is not covered separately under the home IVIG items and 
services payment.
---------------------------------------------------------------------------

    \104\ Updated Interim Report to Congress: Evaluation of the 
Medicare Patient Intravenous Immunoglobulin Demonstration Project, 
August 2022 found at: https://innovation.cms.gov/data-and-reports/2022/ivig-updatedintrtc.
    \105\ https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?LCDId=33794.
---------------------------------------------------------------------------

2. Home IVIG Items and Services and the Relationship to/Interaction 
With Home Health and Home Infusion Therapy Services
    Prior to enactment of the CAA, 2023, IVIG administration items and 
services were explicitly excluded from coverage under the Part B IVIG 
benefit. However, if a beneficiary was considered homebound and 
qualified for the home health benefit, the items and services needed to 
administer IVIG in the home could be covered as home health services. 
Section 4134(b) of the CAA, 2023 excludes the IVIG items and services 
bundled payment in the case of an individual receiving home health 
services under section 1895 of the Act. Therefore, we clarified in the 
CY 2024 HH PPS final rule that a beneficiary does not have to be 
considered confined to the home (that is, homebound) in order to be 
eligible for the home IVIG benefit; however, homebound beneficiaries 
requiring items and services related to the administration of home 
IVIG, and who are receiving services under a home health plan of care, 
may continue to receive services related to the administration of home 
IVIG as covered home health services (88 FR 77794). We also clarified 
that the items and services related to the administration of IVIG in 
the home, and as identified on the home health plan of care, will be 
included in the payment for the 30-day home health period payment. HHAs 
must provide home health items and services included on the plan of 
care either directly or under arrangement and must bill and be paid 
under the HH PPS for such covered home health services. If an HHA is 
unable to furnish the items and services related to the administration 
of IVIG (as indicated in the plan of care) in the home, they are 
responsible for arranging these services (including arranging for 
services in an outpatient facility) and are required to bill these 
services as home health services under the HH PPS (88 FR 77795).
    Regarding the home infusion therapy (HIT) services benefit, we 
reminded readers that Medicare payment for home infusion therapy 
services is for services furnished in coordination with the furnishing 
of intravenous and subcutaneous infusion drugs and biologicals 
specified on the DME LCD for External Infusion Pumps (L33794),\106\ 
with the exception of insulin pump systems and certain drugs and 
biologicals on a self-administered drug exclusion list (88 FR 77794). 
For the drugs and biologicals to be covered under the Part B DME 
benefit they must require infusion through an external infusion pump. 
If the drug or biological can be infused through a disposable pump or 
by a gravity drip, it does not meet this criterion. IVIG does not 
require an external infusion pump for administration purposes and 
therefore, is explicitly excluded from the DME LCD for External 
Infusion Pumps. However, subcutaneous immunoglobulin (SCIg) is covered 
under the DME LCD for External Infusion Pumps, and items and services 
for administration of SCIg in the home are covered under the HIT 
services benefit. While a DME supplier and a HIT supplier (or a DME 
supplier also enrolled as a HIT supplier) could not furnish services 
related to the administration of immunoglobulin (either IVIG or SCIg) 
to the same beneficiary on the same day, a beneficiary could 
potentially receive services under both benefits for services related 
to the infusion of different drugs. For example, a DME supplier also 
accredited and enrolled as a HIT supplier, could furnish HIT services 
to a beneficiary receiving intravenous acyclovir as well as IVIG, and 
bill both the IVIG items and services benefit and the HIT services 
benefit on the same date of service. We also recognize that a 
beneficiary may, on occasion, switch from receiving immunoglobulin 
subcutaneously to intravenously and vice versa, and as such, utilize 
both the HIT services and the IVIG items and

[[Page 88451]]

services benefits within the same month.
---------------------------------------------------------------------------

    \106\ Local Coverage Determination (LCD): External Infusion 
Pumps (L33794) https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?LCDId=33794.
---------------------------------------------------------------------------

C. Home IVIG Administration Items and Services Payment

    Section 101 of the Medicare IVIG Access Act established the 
authority for a Demonstration providing payment for items and services 
needed for the in-home administration of IVIG. In the CY 2024 HH PPS 
final rule, we stated that we believed the provisions established under 
that law serve as the basis for the conditions for payment with respect 
to the requirements that must be met for Medicare payment to be made to 
suppliers for the items and services covered under section 
1861(s)(2)(Z) of the Act and clarified that the relevant regulations 
and subregulatory guidance also apply.
1. Home IVIG Administration Items and Services Supplier Type
    Section 4134(b) of the CAA, 2023 amends section 1842(o) of the Act 
by adding a new paragraph (8) that establishes a separate bundled 
payment to the supplier for all items and services related to the 
administration of such intravenous immune globulin, described in 
section 1861(s)(2)(Z) of the Act to such individual in the patient's 
home during a calendar day. Section 4134(c) of the CAA, 2023 amends 
section 1834(j)(5) of the Act, which are a requirement for supplier of 
medical equipment and supplies, by adding a new subparagraph (E), 
clarifying with respect to payment, that items and services related to 
the administration of intravenous immune globulin furnished on or after 
January 1, 2024, as described in section 1861(zz) of the Act, are 
included in the definition of medical equipment and supplies. This 
means that suppliers that furnish IVIG administration items and 
services must meet the existing durable medical equipment, prosthetics, 
orthotics, and supplies (DMEPOS) supplier requirement for payment 
purposes under this benefit. Suppliers of IVIG administration items and 
services must enroll as a DMEPOS supplier and comply with the Medicare 
program's DMEPOS supplier standards (found at 42 CFR 424.57(c)) and 
DMEPOS quality standards to become accredited for furnishing medical 
equipment and supplies. Further, to receive payment for home IVIG items 
and services, the supplier must also meet the requirements under 
subpart A of part 424 (Conditions for Medicare Payment). The DMEPOS 
supplier may subcontract with a provider to meet the professional 
services identified in section V.B.1. of this final rule. All 
professionals who furnish services directly, under an individual 
contract, or under arrangement with a DMEPOS supplier to furnish 
services related to the administration of IVIG in the home, must be 
legally authorized (licensed, certified, or registered) in accordance 
with applicable Federal, State, and local laws, and must act only 
within the scope of their State license or State certification, or 
registration. A supplier may not contract with any entity that is 
currently excluded from the Medicare program, any State health care 
programs or from any other Federal procurement or non-procurement 
programs.
2. Home IVIG Administration
    Section 1861(s)(2)(Z) of the Act defines benefit coverage of 
intravenous immune globulin for the treatment of primary immune 
deficiency diseases in the home. Under the IVIG Demonstration, 
beneficiaries are eligible to participate if they receive IVIG services 
in ``their home or a setting that is `home like' ''.\107\ Section 
410.12(b) identifies the supplier types who can furnish the services 
identified at Sec.  410.10. Section 410.38 provides the conditions for 
payment for DME suppliers and identifies the institutions that may not 
qualify as the patient's home. As such, the home administration of IVIG 
items and services must be furnished in the patient's home, defined as 
a place of residence used as the home of an individual, including an 
institution that is used as a home. An institution that is used as a 
home may not be a hospital, critical access hospital (CAH), or SNF as 
defined in Sec.  410.38(b).
---------------------------------------------------------------------------

    \107\ Intravenous Immune Globulin Demonstration MLN Fact Sheet: 
https://www.cms.gov/files/document/mln3191598-intravenous-immune-globulin-demonstration.pdf.
---------------------------------------------------------------------------

D. Home IVIG Items and Services Payment Rate

1. Payment Rate Update for Home IVIG Items and Services for CY 2025
    Section 1842(o) of the Act provides the authority for the 
development of a separate bundled payment for Medicare-covered items 
and services related to the administration of intravenous immune 
globulin to an individual in the patient's home during a calendar day, 
in an amount that the Secretary determines to be appropriate. This 
section of the Act also states payment may be based on the payment 
established pursuant to section 101(d) of the Medicare IVIG Access Act. 
Section 4134(d) of the CAA, 2023 amends section 1833(a)(1) of the Act 
to provide that, with respect to items and services related to the 
administration of IVIG furnished on or after January 1, 2024, as 
described in section 1861(zz) of the Act, the amounts paid shall be the 
lesser of the 80 percent of the actual charge or the payment amount 
established under section 1842(o)(8) of the Act.
    In accordance with section 101(d) of the Medicare IVIG Access Act, 
the Secretary established a per visit Demonstration payment amount for 
the items and services needed for the in-home administration of IVIG 
based on the national per visit low-utilization payment amount (LUPA) 
under the prospective payment system for home health services 
established under section 1895 of the Social Security Act. Under the 
Demonstration, the bundled payment amount for services needed for the 
home administration of IVIG included infusion services provided by a 
skilled nurse. Therefore, the bundled payment was based on the LUPA 
amount for skilled nursing, based on an average 4-hour infusion. The 
initial payment rate for the first year of the Demonstration, was based 
on the full skilled nursing LUPA for the first 90 minutes of the 
infusion and 50 percent of the LUPA for each hour thereafter for an 
additional 3 hours. Thereafter, the payment rate was annually updated 
based on the nursing LUPA rate for such year. The service was subject 
to coinsurance and deductibles similar to other Part B services.
    We stated in the CY 2024 HH PPS proposed rule (88 FR 43755), we 
believed payment under section 1861(s)(2)(Z) of the Act covers the same 
items and services covered under the IVIG Demonstration. We also agreed 
that the professional services needed to safely administer IVIG in the 
home will be services furnished by a registered nurse (88 FR 43756). 
Therefore, we stated that setting the CY 2024 payment rate for the home 
IVIG items and services under section 1861(s)(2)(Z) of the Act, based 
on the CY 2023 payment amount established under the Demonstration was 
appropriate. However, we noted the Demonstration used the LUPA rate, 
which is annually adjusted by the wage index budget neutrality factor, 
as well as the home health payment rate update percentage, and stated 
that we believed it was appropriate to update the CY 2023 IVIG services 
Demonstration rate by only the CY 2024 home health payment rate update 
percentage. We stated that we will not include the wage index budget 
neutrality factor, as the IVIG items and services payment rate is not 
statutorily required to be geographically wage adjusted. Further, 
although section 1842(o) of the Act states that payment is for the 
items and services furnished

[[Page 88452]]

to an individual in the patient's home during a calendar day, we stated 
that, as the statute aligns the payment amount with such amount 
determined under the Demonstration, we believed the best reading of 
``calendar day'' is ``per visit.'' Additionally, we stated that we will 
expect a supplier to furnish only one visit per calendar day (88 FR 
43756).
    In the CY 2024 HH PPS final rule, we established a new subpart R 
under the regulations at 42 CFR part 414 to incorporate payment 
provisions for the implementation of the IVIG items and services 
payment in accordance with section 1842(o) of the Act for home IVIG 
items and services furnished on or after January 1, 2024. We finalized 
a policy at Sec.  414.1700(a), that a single payment amount is made for 
items and services furnished by a DMEPOS supplier per visit. We 
finalized a policy at Sec.  414.1700(b), setting the initial payment 
amount equivalent to the CY 2023 ``Services, Supplies, and Accessories 
Used in the home under the Medicare IVIG Demonstration'' payment 
amount, updated by the CY 2024 home health update percentage of 3.0 
percent. We also finalized a policy at Sec.  414.1700(c) to annually 
update the CY 2025 home IVIG items and services payment rate and 
subsequent years, by the home health payment rate update percentage for 
such year. Therefore, in the CY 2025 HH PPS proposed rule, we proposed 
the CY 2025 home IVIG items and services payment rate would be the CY 
2024 IVIG items and services payment rate of $420.48 updated by the 
proposed home health payment update percentage of 2.5 percent ($420.48 
* 1.025 = $430.99).
    Comment: We received a few comments on the CY 2025 update of the 
home IVIG items and services payment rate. Overall, commenters remained 
supportive of CMS's implementation of the home IVIG items and services 
benefit, including the payment rate increase. However, one commenter 
stated that the LUPA-based rate calculation for the IVIG items and 
services payment rate undervalues the nursing and pharmacy services 
involved in the provision of home-administered IVIG. This commenter 
stated this rate does not account for costs such as travel time, 
dedicated one-on-one nursing, and other pharmacy-related expenses that 
happen remotely. A commenter also requested CMS publish an annual 
report on the home IVIG items and services benefit, similar to the HIT 
Monitoring Report.
    Response: The comments regarding the methodology that established 
the initial home IVIG items and services rate are out of scope of this 
rule, as this policy was finalized in the CY 2024 HH PPS final rule; 
however, since the implementation of the home IVIG Demonstration 
Program, CMS has interpreted the services covered under this payment to 
be nursing services furnished in the patient's home. Indeed, the 
Medicare IVIG Access Act statutorily required this payment to be based 
on the national per visit low-utilization payment adjustment (LUPA) for 
skilled nursing services used under the Medicare HH PPS established 
under section 1895 of the Act. In addition, section 1842(o)(8) of the 
Act states that payment may be based on the payment established 
pursuant to subsection (d) of section 101 of the Medicare IVIG Access 
and Strengthening Medicare and Repaying Taxpayers Act of 2012. We 
anticipate including a public monitoring report on the home IVIG items 
and services benefit on our Home Infusion Therapy (HIT)/IVIG web page 
at https://www.cms.gov/medicare/payment/fee-for-service-providers/home-infusion-therapy once we have sufficient data.
    After consideration of the public comments we received, we are 
finalizing the CY 2025 home IVIG items and services payment rate of 
$431.83 ($420.48 updated by the final home health payment update 
percentage of 2.7 percent ($420.48 * 1.027 = $431.83)). The final home 
IVIG items and services payment rate will be posted in the Billing and 
Rates section of the CMS' Home Infusion Therapy (HIT) web page (found 
at https://www.cms.gov/medicare/payment/fee-for-service-providers/home-infusion-therapy).
    In subsequent years, if CMS does not intend to propose changes to 
its established methodology for calculating the IVIG items and services 
payment, this payment rate will be updated using CMS's established 
methodology via the Home Health Prospective Payment System Rate Update 
Change Request or Technical Direction Letter (TDL) and posted on the 
CMS HIT/Home IVIG Services web page.\108\ For more in-depth information 
regarding the finalized policies associated with the scope of the home 
IVIG items and services payment, we refer readers to the CY 2024 HH PPS 
final rule (88 FR 77791).
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    \108\ https://www.cms.gov/medicare/payment/fee-for-service-providers/home-infusion-therapy.
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VI. Home Health Agency Condition of Participation (CoP) Changes and 
Long Term Care (LTC) Facility Requirements for Acute Respiratory 
Illness Reporting

A. Home Health Agency CoP Changes

1. Background and Statutory Authority
    CMS has broad statutory authority to establish health and safety 
standards for most Medicare- and Medicaid-participating provider and 
supplier types. The Secretary gives CMS the authority to enact 
regulations that are necessary in the interest of the health and safety 
of individuals who are furnished services in an institution, while 
other laws, as outlined later, give CMS the authority to prescribe 
regulations as may be necessary to carry out the administration of the 
program. Sections 1861(o) and 1891 of the Act authorize the Secretary 
to establish the requirements that an HHA must meet to participate in 
the Medicare Program, and these conditions of participation (CoPs) are 
set forth in regulations at 42 CFR part 484.
    The CoPs apply to the HHA as an entity, as well as to the services 
furnished to each individual patient under the care of the HHA. In 
accordance with section 1861(o) of the Act, the Secretary is 
responsible for establishing additional CoPs besides those set out in 
the statute that are adequate to protect the health and safety of the 
individuals under HHA care. Section 1891(c)(2) of the Act establishes 
the requirements for surveying HHAs to determine whether they meet the 
CoPs.
2. Updates to the Home Health Agency CoPs To Require HHAs To Establish 
an Acceptance-to-Service Policy (Sec.  484.105(i))
    Admission to HHA services is a critical step in the process of 
patients receiving timely, appropriate care to meet their needs. In 
accordance with the requirements of Sec.  484.105(f)(1), each HHA must 
furnish skilled nursing services and at least one other therapeutic 
service (physical therapy, speech-language pathology, occupational 
therapy, medical social services, or home health aide services) on a 
visiting basis and in a place of residence that is used as a patient's 
home. As such, the services provided by each HHA vary, creating 
challenges for individuals seeking to find the right HHA to meet their 
unique care needs. Likewise, the unique mix of services provided by an 
HHA also necessitates an HHA-specific approach to accepting referrals 
for care to ensure that the HHA is capable of meeting the needs of the 
referred patient, in accordance with the

[[Page 88453]]

requirements of Sec.  484.60. Thus, a timely, appropriate admission 
process serves both prospective patients seeking care and ensures that 
HHAs accept for treatment only those patients for whom there is a 
reasonable expectation of being able to meet the patient's care needs.
    As described in the CY 2025 HH PPS proposed rule, researchers have 
found that timely admission to home health, and in turn the initiation 
of services are key to good home health patient outcomes. To address 
concerns regarding the referral and acceptance process and their 
implications for prospective and current patients, we proposed to add a 
new standard at Sec.  484.105(i) that would require HHAs to develop, 
implement, and maintain an acceptance-to-service policy that is applied 
consistently to each prospective patient referred for home health care. 
We proposed, at Sec.  484.105(i)(1)(i) through (iv), to require that 
the policy be reviewed annually and address, at minimum, the following 
criteria related to the HHA's capacity to provide patient care: the 
anticipated needs of the referred prospective patient, the HHA's case 
load and case mix, the HHA's staffing levels, and the skills and 
competencies of the HHA staff. These proposed elements were designed to 
inform an HHA's assessment of its capacity and determine its 
suitability to meet the anticipated needs of the prospective patient 
that has been referred for HHA services. We also proposed that the 
patient acceptance-to-service policy be applied consistently to ensure 
that HHAs only accept those patients for whom there is a reasonable 
expectation that the HHA can meet the referred patient's needs.
    We received a total of 78 comments from individuals, health care 
professionals, national associations and patient advocacy groups. In 
the following section, we discuss the public comments received on Sec.  
484.105(i) that would require HHAs to develop, implement, and maintain 
an acceptance-to-service policy that is applied consistently to each 
prospective patient referred for home health care.
    Comment: A few commenters supported the proposal for HHAs to 
develop, implement, and maintain an acceptance-to-service policy, with 
some observing that acceptance-to-service is an equity issue and that 
delays in finding appropriate care can worsen outcomes for patients. A 
commenter supported the clarification that HHAs should not accept 
patients they cannot serve. However, another commenter recommended that 
CMS ensure that the proposed acceptance-to-service policy does not 
result in the denial of access to services because the acceptance-to-
service policy erroneously indicates that the HHA is unable to meet a 
specific patient's needs. A commenter stated that the acceptance-to-
service policy would lead to improved workload distribution for HHA 
staff but expressed concern that HHA administrators may misrepresent 
the skills of the staff in order to accept more patients.
    Conversely, other commenters expressed concern regarding the 
proposed policy, suggesting that the existing requirements already 
adequately address patient access to home health services and that HHAs 
would not accept patients to whom they could not reasonably expect to 
provide care. A commenter shared that HHAs may already use the proposed 
factors in determining whether to accept patients but that maintaining 
the information in an appropriate format would add burden. Commenters 
stated that the proposed CoP would not address the underlying 
challenges that prevent HHAs from accepting patients, such as staffing 
challenges, patient complexity, unnecessary work due to referrals being 
sent to multiple HHAs, care needs that are inappropriate for the home 
setting, an inability to identify a community practitioner to oversee 
patient care, and challenges in receiving responses to questions 
regarding care plans from referring providers. These commenters 
suggested not finalizing the proposed requirements and proposing 
different requirements in the future, with one commenter recommending 
that CMS convene a TEP to better understand the challenges associated 
with finding appropriate home health care.
    Response: We appreciate the commenters support for these new 
proposals. While we agree that the existing CoPs already address some 
essential steps in the acceptance and admission process, we do not 
agree that these existing requirements fully meet the needs of 
patients. While we acknowledge the feedback highlighting the varying 
underlying challenges that may prevent HHAs from accepting patients, as 
noted by some commenters, delays in finding appropriate care can worsen 
outcomes for patients and acceptance-to-service may be an equity issue 
for patients with complex needs. The consistent application of an 
acceptance-to-service policy to all referrals, when combined with 
making certain information publicly available, is likely to reduce 
delays in finding appropriate care while ensuring that clinical factors 
are used to guide decision making on accepting patients to HHA service, 
so as to assure that an HHA is prepared to meet each patient's care 
needs.
    We also agree with the commenter that the acceptance-to-service 
policy may lead to a better HHA staff workload distribution as HHAs use 
a more deliberative, equally applied approach in accepting patients for 
HHA services. In accordance with the requirements of Sec.  484.105, the 
HHA must organize, manage, and administer its resources to attain and 
maintain the highest practicable functional capacity, including 
providing optimal care to achieve the goals and outcomes identified in 
the patient's plan of care, for each patient's medical, nursing, and 
rehabilitative needs. As such, each HHA should already be well versed 
in understanding staff ability and skills, current workloads and other 
circumstances that may affect case load. These are well established 
concepts that we are formalizing within a policy that we expect will be 
applied equally and consistently when evaluating prospective referred 
patients. We appreciate the commenter sharing the observation that some 
HHAs have existing referral policies that reflect some of the 
requirements included in our proposal and that HHAs are already using 
these factors in determining whether to accept patients. We note that 
we also received a comment stating that one HHA accreditation 
organization already requires HHAs to have a referral policy. 
Therefore, we believe that many HHAs have existing policies and 
procedures that will support compliance with these new requirements and 
minimize the aggregate initial effort necessary to work towards 
compliance.
    Comment: A commenter stated that data collection and reporting for 
such a policy will create additional administrative burden for HHAs. 
Other commenters expressed general concerns about the potential burdens 
of developing and maintaining an acceptance-to-service policy, with one 
suggesting that CMS should reimburse HHAs for the time and effort 
required to develop and maintain such policies.
    Response: We understand commenters concerns regarding burden, 
specifically, the development and maintenance of the policy. However, 
we believe the benefits to the referred and current patient, in terms 
of enabling more timely care and better outcomes outweigh the 
administrative costs of policy development. Furthermore, as noted 
previously, many commenters have acknowledged existing business 
practices that support compliance with the policy. We encourage HHAs to 
leverage their partnerships throughout

[[Page 88454]]

the stakeholder community to gain exposure to existing practices that 
could assist in minimizing facility burden associated with compliance.
    Comment: Some commenters suggested regarding ways to revise the 
proposed policy, such as addressing the HHA's ability to provide the 
required services, criteria to determine the patient's eligibility for 
care, and procedures for accepting referrals. A commenter also stated 
that appropriate patient placement with a home health agency is more 
nuanced than simply tracking staffing numbers and general competencies. 
The commenter recommended ensuring HHAs include nurse input to 
determine whether a patient placement within an agency is possible 
based on patient acuity and care levels.
    Response: We agree that appropriate patient placement with a home 
health agency is complex and that it is important that the HHAs have 
the appropriate staff input to determine whether a patient placement 
within an agency is possible based on patient acuity, care levels, and 
HHA resources. We acknowledge that the skills and clinical knowledge of 
a nurse may be beneficial to this process. However, we recognize that 
there are other clinicians, such as rehabilitation therapists, that may 
be appropriate as well. Therefore, we believe it is best to allow the 
HHA the flexibility to determine which staff members should be included 
in this process. We agree that HHAs should also consider including 
criteria to determine the patient's eligibility for care and procedures 
for accepting referrals as part of their acceptance-to-service policy 
to improve their referral acceptance process. While we agree that 
procedures for accepting patient referrals may fall within the scope of 
the CoPs, we do not believe that it is necessary to add this regulatory 
requirement for specific procedures at this time. We will continue to 
monitor the timeliness of patient access to HHA services and follow-on 
initial patient assessment activities to determine whether such 
regulations may be needed in the future.
    Comment: A few commenters expressed concern that CMS did not 
discuss how HHAs would be evaluated for their compliance with the 
acceptance-to-service policy. Some of these commenters stated that HHAs 
would have to begin tracking patients that were referred to their 
agency but not accepted for service because currently HHAs only have 
data regarding patients to whom they provide care. In addition, 
commenters expressed concern that this policy would focus on access 
instead of quality and safety, and that surveyors would require 
training to be able to fairly and consistently evaluate compliance. A 
commenter recommended that CMS collect data regarding patients who are 
denied service, and that CMS provide oversight and enforcement to 
prevent HHAs from using capacity as a rationale for declining to 
provide service to patients with chronic or complex needs. The 
commenter stated that regulators could review referral and rejection 
lists, and that by analyzing these lists regulators can identify 
reasons for rejections and address those underlying reasons.
    Response: The proposed and final policies focus on the health and 
safety of HHA patients by instituting regulatory policies that will 
reduce avoidable care delays that are known to increase the risk of 
hospital readmissions. We seek to ensure that eligible patients receive 
timely care to reduce the likelihood of these readmissions and other 
negative consequences that may occur when a patient is referred for 
home health services but does not receive timely care. We expect each 
HHA to develop its acceptance-to-service policy taking into 
consideration the criteria outlined in the final CoP. HHAs will be 
required to include information regarding the HHA's case load and case 
mix (that is, the volume and complexity of the patients currently 
receiving care from the HHA), anticipated needs of the referred 
prospective patient, the HHA's current staffing levels, and the skills 
and competencies of the HHA staff. These elements are designed to 
inform an HHA's assessment of its capacity and determine its 
suitability to meet the anticipated needs of the prospective patient 
that has been referred for HHA services.
    While all of a prospective patient's needs may not be known at the 
time of referral, general information regarding the patient's diagnosis 
and recent hospitalization (as appropriate), and specific orders from 
the patient's medical provider should provide a reasonable basis for 
HHAs to anticipate the overall needs of the patient and determine 
whether, in light of the described factors, the prospective patient is 
or is not appropriate for the HHA to accept for service. HHAs will be 
assessed for their compliance with the requirements set forth at Sec.  
484.105(i). Section 484.105(i) does not include a requirement to track 
patients that are not accepted for service nor any other data 
collection requirements. HHAs are encouraged to track this information 
to ensure that their services align with the needs of the communities 
they serve. HHAs may use this data for their quality assessment and 
performance improvement (QAPI) programs to evaluate the services 
provided and examine potential areas of growth to best meet the needs 
of their potential patients. We remind HHAs that they are required to 
comply with Title VI of the Civil Rights Act of 1964, section 504 of 
the Rehabilitation Act of 1973, Title II of the Americans with 
Disabilities Act, the Age Discrimination Act of 1975, and section 1557 
of the Affordable Care Act. Furthermore, interpretive guidance for the 
final policy will be released following the publication of this final 
rule and will provide additional information regarding oversight and 
enforcement of the requirements.
    Comment: Some commenters shared that an acceptance-to-service 
policy for HHAs would inappropriately place the entire responsibility 
for timely initiation of care on HHAs when this responsibility is 
shared between referral sources and HHAs. The commenter also stated 
that there are often communications gaps between patients, referral 
sources, and HHAs which can lead to wasted time and resources (for 
example, a patient being referred to two HHAs or an HHA which is not 
notified when the patient is no longer at home and has been admitted or 
readmitted for inpatient care).
    Response: We agree that HHAs are responsible for their own policies 
and procedures and share patient care responsibilities with the 
practitioners that oversee the HHA plan of care. The acceptance-to-
service policy includes four minimum requirements related to clinical 
factors that influence whether an HHA should accept or decline a 
referral to ensure the health and safety or the referred patient by 
matching HHA services to patient needs. Within this structure HHAs may 
tailor their policy to address additional concerns and procedural 
delays and challenges that they typically face in the referral and 
acceptance process. It is the responsibility of the HHA to work with 
its referral sources by educating them on the HHA acceptance-to-service 
policy and services the HHA offers with the goal to minimize the 
communication gaps.
    Comment: A commenter supported the statement that acceptance-to-
service should not be based on payment source; conversely, a few other 
commenters did not support this concept. A commenter expressed that 
because HHAs lose money providing care for some patients they must have 
a patient load balanced across payers with higher and lower payment 
rates. This commenter also

[[Page 88455]]

expressed that while an HHA may be a Medicare-certified provider, they 
may not be in-network for all MA plans, and even those for which they 
are in network may have lengthy and complicated prior authorization 
processes. This commenter also expressed concern that the proposal was 
intended to improve access for patients with Medicaid and stated that 
this is an inappropriate use of the Medicare CoPs.
    Response: In accordance with Sec.  484.105, an HHA must organize, 
manage, and administer its resources to provide optimal care to achieve 
the goals established in each patient's individualized plan of care. 
When accepting patients, the primary consideration of all HHAs must be 
whether the HHA has the resources available to meet the needs of the 
prospective patient, so as to avoid accepting those patients for whom 
the HHA does not have a reasonable expectation of being able to meet 
the patient's needs in their home environment.
    Comment: A commenter stated that it is not uncommon for an HHA to 
accept a patient for whom they cannot provide sufficient care and that 
the patient's needs may be met by non-profits.
    Response: While all of a prospective patient's needs may not be 
known at the time of referral, general information regarding the 
patient's diagnosis and recent hospitalization (as appropriate), and 
specific orders from the patient's medical provider would provide a 
reasonable basis for HHAs to anticipate the overall needs of the 
patient and determine whether the prospective patient is or is not 
appropriate for the HHA to accept for service. At Sec.  484.60, we 
require HHAs to accept patients for treatment on the reasonable 
expectation that an HHA can meet the patient's medical, nursing, 
rehabilitative, and social needs in their place of residence. 
Therefore, the information the commenter shared reflects a lack of 
compliance with current regulations. Patients and caregivers may choose 
to use additional community services to augment the services provided 
by an HHA, but an HHA may not choose to provide reduced services for 
the convenience of the HHA when the patient's need for a higher level 
of services remains unchanged. In accordance with Sec.  484.60, HHAs 
are responsible for implementing an individualized plan of care that 
specifies the care and services necessary to meet the patient-specific 
needs as identified in the comprehensive assessment, and that 
identifies patient-specific measurable outcomes and goals identified by 
the HHA.
    Comment: A commenter stated that the proposed rule did not provide 
a clear definition of ``timely initiation'' which would be important in 
evaluating acceptance-to-service. This commenter stated that the 
current definition of ``timely initiation of care'' is part of the HH 
QRP based on OASIS data.
    Response: We agree that this term may be used and defined in other 
HHA programs that are not part of the CoPs. The specific proposed 
requirement at Sec.  484.105(i) did not include the term ``timely 
initiation'' and it would not be appropriate to define in the CoPs a 
term that was not used in the CoPs.
    Final Rule Action: After consideration of public comments, we are 
finalizing the acceptance-to-service policy at Sec.  484.105(i)(1) as 
proposed.
3. Updates to the Home Health CoPs To Require HHAs To Make Information 
Public on Offered Services and Service Limitations (Sec.  
484.105(i)(2))
    Home health agencies have the ability to select the services that 
they furnish and the geographic areas that they serve. Knowing which 
areas are served by an HHA and which services an HHA does and does not 
provide will assist referral sources, patients, and caregivers engaged 
in a search for home health services in identifying the most suitable 
HHA. Likewise, each HHA has fluctuating staffing levels and staffing 
competencies affecting its capacity to deliver patient care and provide 
its typically offered services. Therefore, at Sec.  484.105(i)(2) we 
proposed to require that HHAs make public accurate information 
regarding the services offered by the HHA, such limitations on 
specialty services, service duration, and service frequency to further 
inform the search efforts of all referral sources. We also proposed 
that HHAs review this information at least annually. This will 
facilitate the search for an HHA to meet a patient's needs, both from 
clinical referral sources, and from patients and caregivers directly 
seeking care. The goal is to reduce the delay between the time when a 
patient is identified as an eligible candidate for home health care and 
the time when care is initiated by making key information readily 
available, thus improving identification of HHAs capable of meeting 
patient needs. Reducing the time delay would improve patient outcomes, 
as longer delays between referral and the initiation of HHA care are 
more likely to result in adverse outcomes, including 30-day 
rehospitalizations.
    In the following section we discuss the public comments received 
and our responses on proposed Sec.  484.105(i)(2) which would require 
HHAs to make public accurate information regarding services offered, 
service limitations, and service frequency.
    Comment: A few commenters expressed support with recommendations 
for the proposed requirement for HHAs to make public accurate, current 
information on the services they offer. These commenters stated that 
this could expedite connecting beneficiaries to agencies and provide 
meaningful data about which agencies accept patients with complex and 
long-term needs. A commenter stated that the proposed requirement will 
provide useful information about areas where there may be gaps in HHAs 
that provide specific services or are able to accept complex patients. 
Likewise, a commenter noted that the proposed regulation promotes 
public transparency and highlights the importance of timely initiation 
of care. A commenter recommended that the information be presented in a 
manner that is user-friendly, and culturally and linguistically 
appropriate. Another commenter recommended additional information that 
would be useful for patients in selecting an HHA, including languages 
in which staff are fluent, a count of staff fluent in each language, 
and patient to staff ratios.
    Response: We thank commenters for their support and for 
highlighting how this policy will help promote transparency, ensure 
timely patient admission, and thus initiation of HHA services. We agree 
with the commenters that making available information about the 
services offered by the HHA and any limitations on those services may 
provide public transparency and highlights the importance of timely 
initiation of care as well as provide useful information about areas 
where there may be gaps in HHAs that provide specific services. We 
acknowledge the importance of providing information in an accessible 
manner. We are providing HHAs with the flexibility to provide 
information regarding their services in multiple formats (for example, 
Care Compare). We remind HHAs of their requirement to comply with 
section 508 of the Rehabilitation Act when developing and publishing 
this information for the public.
    Comment: Several commenters stated that they did not support the 
proposed adoption of an acceptance-to-service policy requirement 
because of concerns that the data could not reasonably be kept up to 
date and would therefore not be able to meaningfully help patients and 
referrers identify appropriate HHAs for care needs. Several commenters 
stated that staffing and ability to accept new referrals changes on a 
daily basis

[[Page 88456]]

and that changing publicly reported information that frequently could 
be confusing for patients and other providers. Other commenters 
recommended that CMS establish standards for updating publicly posted 
information more frequently than the proposed annual review of 
information. These commenters stated that staffing levels change 
regularly and suggested timeframes for updates such as monthly or upon 
a major change in service abilities. For example, a few commenters 
stated that the requirement to update public information about 
acceptance-to-service policies on an ``annual or as necessary'' basis 
is not sufficiently clear. These commenters recommend that CMS provide 
more detail on what would qualify for the ``as necessary'' standard. 
Other commenters sought additional clarity on how frequently this 
information should be updated and how the information would be 
evaluated.
    Response: We believe that these comments are not related to the 
acceptance-to-service policy set forth on proposed Sec.  484.105(i)(1), 
but to the proposed requirement at Sec.  484.105(i)(2) that HHAs would 
make publicly available information regarding the services they 
offered, and any limitations related to types of specialty services, 
service duration, or service frequency. We thank commenters for 
clarifying how frequently HHA services are updated or changed. While we 
acknowledge the potential challenges of keeping this information up to 
date, failing to do so may contribute to delays in patients receiving 
needed home healthcare that may increase the likelihood of 
rehospitalization, as well as increase the number of dual eligible 
patients and other vulnerable populations at risk for poor outcomes. 
According to one study published in 2021, when the initiation of home 
health services is significantly delayed (that is, from 8 to 14 days 
after discharge), the odds of rehospitalization for diabetic patients 
were four times greater compared to patients receiving home health 
service initiation within 2 days.\109\ Yet the rate of timely 
initiation of home health care varies significantly, indicating that 
the referral and acceptance process is in need of improvement.
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    \109\ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8197411/.
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    While making this required information publicly available may 
initially present a new challenge for HHAs, the greater clarity between 
HHAs, patients and referral sources may improve the HHAs relationships 
with the community they serve and reduce instances of avoidable 
confusion and delays. To ensure that the information presented to the 
public is accurate, we are revising the policy to require HHAs to 
review publicly facing information as frequently as services are 
changed, but no less often than annually. We would expect HHAs to 
update the information regarding their services provided and service 
limitations if the HHA anticipates it will not have a service available 
for 3 to 6 months. Changing a service means the HHA has formally 
altered the services it offers, whether by adding, discontinuing, or 
temporarily pausing or restricting a service. For example, a change in 
service may include an employee taking an extended leave of absence 
(that is, care for a family member, recovery from a serious illness or 
procedure, maternity leave) or the addition of a new contract employee 
that provides speech language pathology services, which a HHA may not 
have provided before.
    Providing the most up to date information on services provided and 
service limitations will allow patients, their families, and/or their 
caregiver(s) to make educated decisions about which HHA will best meet 
their physical, psychosocial, and rehabilitative needs. HHAs are 
already required by Sec.  484.105 to document, in writing, the services 
that they furnish. The governing body is responsible for assuring that 
this is done as part of their oversight responsibilities set forth in 
Sec.  484.105(a). As such, we would expect to see evidence of governing 
body decision making on the services offered, corresponding revisions 
to the written list, and corresponding updates to its public facing 
information. After publication of this final rule, CMS will provide 
additional guidance on enforcement through memoranda and updates to the 
State Operations Manual (Pub. 100-07), as needed.
    Comment: A commenter expressed concern that the policy may prohibit 
HHAs from accepting patients that they would be able to serve given 
their actual staffing, but that their published acceptance-to-service 
policy would indicate that they could not serve.
    Response: The information about services and limitations made 
publicly available would in no way prohibit an HHA from accepting a 
referral. Referral acceptance is governed by the HHAs acceptance-to-
service policy set forth in Sec.  484.105(i)(1), which requires HHAs to 
develop and implement a policy based on specified clinical factors to 
ensure that HHAs only accept those patients for whom they have a 
reasonable expectation of being able to meet the patient's care needs 
in their home environment.
    Comment: A commenter stated that providing information regarding an 
HHA's capacity on a public website would not provide meaningful 
information to patients because home health referrals must be completed 
by a medical professional and therefore patients and their families 
would not be able to self-refer to such a provider.
    Response: We did not propose, nor are we finalizing, a requirement 
for HHAs to post information regarding their capacity on a website. 
Rather, we proposed and are finalizing a requirement that HHAs make 
publicly available information regarding the services that they offer 
and limitations on those services, such as offering nursing services 
but not advanced wound care services as a specialty. The capacity of an 
HHA to deliver care to a referred patient is accounted for in the 
internal policy that HHAs will develop and use when making acceptance-
to-service decisions. By accounting for the referred patient's 
anticipated needs and considering the HHA's available resources, HHAs 
will self-assess their capacity to serve the referred person and ensure 
their health and safety.
    We do not agree with the suggestion that patients and families are 
not involved in identifying available HHA care. While the official home 
health referral is completed by a medical professional, many patients 
and their family members face the task of seeking out home health care 
to facilitate the official referral process. If a patient's 
practitioner decides they need home health care, the patient has the 
right to participate in choosing the home health agency to meet their 
care needs. While patients have choice, those choices may be limited 
based on the services offered by HHAs, limitations on those services, 
insurance type, and other factors.\110\ Patients and caregivers have 
recounted conducting their own searches for care, often with great 
difficulty. This population has unique needs and circumstances needs 
that may make finding the right HHA challenging, and they may not have 
access to information needed to target their search for an HHA in an 
effective and efficient manner. Patients from community-based referral 
sources tend to be Medicaid recipients, have cognitive impairments, and 
are more socially vulnerable than patients admitted from acute care. 
Additionally, they tend to have received 80 or more hours per month of 
family caregiver assistance prior to their acceptance to

[[Page 88457]]

HHA services.\111\ Encouraging patients and their family members and/or 
caregiver(s) to be more active participants in decision making improves 
patient outcomes.\112\
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    \110\ https://www.cms.gov > HHQIHHBenefits.
    \111\ Social Vulnerability and Medical Complexity Among Medicare 
Beneficiaries Receiving Home Health Without Prior Hospitalization, 
Julia G. Burgdorf, Ph.D., Tracy M. Mroz, OTR/L, Ph.D., and Jennifer 
L. Wolff, Ph.D. Innovation in Aging, 2020, Vol. 4, No. 6, 1-9 
doi:10.1093/geroni/igaa049.
    \112\ https://www.ahrq.gov/health-literacy/professional-training/shared-decision/tool/resource-9.html.
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    Comment: Several commenters did not support a requirement to 
publicly post information regarding a HHA's acceptance-to-service 
policies because many HHAs already post these data on their websites. 
Some commenters also stated that information about services provided is 
available on the CMS Care Compare website and recommended this as the 
appropriate location for information about agency services. A commenter 
recommended linking HHA websites to their information on the Home 
Health Compare website to improve the ease of finding additional 
information about these organizations. A commenter stated that CMS 
posts similar information regarding hospice providers and stated that 
CMS can track and post these data for HH providers as well.
    Response: To clarify, we are not requiring HHAs to publicly post 
information regarding an HHAs acceptance-to-service policy. The 
acceptance-to-service policy is for an agency's internal use and is 
intended to compliment any current policies and procedures HHAs may use 
for tracking referrals and assessing the suitability of the referral 
relative to the HHA's capacity. Instead, HHAs will be required to 
publicly post information regarding their services offered and the 
limitations of these services. CMS recognizes that some of the 
information about services offered may be available on Care Compare. 
Care Compare is designed to be an easy-to-access, convenient source of 
information about provider quality.\113\ HHAs may use Care Compare to 
facilitate compliance with this requirement.
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    \113\ https://www.cms.gov/medicare/quality/home-health/home-health-star-ratings.
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    Alternatively, providing information regarding an HHA's service 
through its website may also facilitate compliance with this 
requirement. HHAs thus have flexibility in achieving compliance with 
this requirement to ensure that public facing information regarding 
services offered by an HHA are available. As previously discussed, we 
remind HHAs of their requirement to comply with section 508 of the 
Rehabilitation Act to ensure that publicly facing information is 
accessible.
    Comment: A commenter stated that publicly posting information 
regarding services offered will have minimal benefit because this 
information will not address individual patient specific circumstances 
and therefore may still not provide patients information regarding 
whether the HHA would be able to address their needs.
    Response: The posting of the services provided by an HHA, and any 
service limitations aims to increase transparency and allow patients 
and their caregiver(s) to make informed decisions when selecting an 
HHA, including the ability to speed their search by eliminating those 
HHAs that do not offer the services the patient needs or whose 
limitations on services make the HHA an unsuitable match. This allows 
patients and their family members and/or caregiver(s) to have a better 
understanding of what HHA may best fulfill their needs and efficiently 
focus their efforts to achieve a timely admission and initiation of HHA 
care, thus benefitting the patient's health and safety.
    Comment: A commenter recommended that instead of publishing 
information regarding services provided and capacity, HHAs should be 
required to disclose any known delays to the services ordered on 
referral prior to admission.
    Response: We are not requiring HHAs to publish information 
regarding capacity, however, this policy does not prevent HHAs from 
doing so. Section 484.105(i)(1) requires the HHA address criteria 
related to their capacity, which includes anticipated needs of the 
referred prospective patient, case load and case mix, staffing levels 
of the HHA, and skills and competencies of the HHA staff. Requiring 
HHAs to publish this information may be too burdensome, as these 
variables may change often. We are requiring HHAs to share information 
with the public regarding limitations related to specialty services, 
service duration, or service frequency. In accordance with Sec.  
484.60, we would expect HHAs to only accept patients that they are able 
to meet the medical, rehabilitative, nursing, and social needs of. 
Additionally, Sec.  484.60(a)(2)(iv) requires the individualized plan 
of care to include the frequency and duration of visits to be made. As 
previously discussed, Sec.  484.55(a)(1) requires the initial 
assessment visit to be held within 48 hours of referral, or within 48 
hours of the patient's return home, or on the physician or allowed 
practitioner-ordered start of care date.
    Final Rule Action: After consideration of public comments, we are 
finalizing the acceptance-to-service policy with revisions. 
Specifically, we are updating the frequency with which HHAs must review 
the publicly facing information regarding their services provided and 
any service limitations to ensure this information is up to date and 
accurate. Specifically, we are revising Sec.  484.105(i)(2), to require 
HHAs to review the publicly facing information as frequently as 
services are changed, but no less often than annually.
4. Request for Public Comments
    In the proposed rule we requested additional feedback of topic 
areas related to the acceptance-to-service policy. Specifically, we 
requested comment on alternative ways to address the delay of home 
health care initiation, barriers for patients with complex needs to 
find and access HHAs, and other opportunities to improve transparency 
regarding home health patient acceptance policies to better inform 
referral sources. We also requested public comment regarding other ways 
to improve the referral process for referral sources, patients, and 
HHAs.
    Many of the commenter's suggestions overlapped with the comments 
received for the proposed acceptance-to-service policy and the RFI on 
``Plan of Care Development and Scope of Services.'' We categorized the 
comments into key themes, as follows: alternative ways to address 
delays, improved referral process, and overall plan of care 
development/scope of service. A few commenters suggested CMS focus on 
improving the establishment of the plan of care as part of the referral 
process. While other commenters suggested CMS engage clinicians to gain 
greater insight on what is happening in the field and using claims-
based measures to gather data, educating hospital discharge planners to 
improve pre-discharge communications with patients and caregivers, and 
evaluating the impact of PDGM on HHAs. We appreciate to wide variety of 
comments received on the question and may use this feedback to inform 
additional rulemaking.
5. Out of Scope
    Comment: Some commenters recommended increasing the focus on 
supporting HHAs by requiring that all payer processes for recoupments, 
vendor holds, undisclosed rate decreases and claim payment denials be 
made transparent by payer sources who frequently disrupt the financial 
operations of HHAs.

[[Page 88458]]

    Response: The CoPs do not regulate payer processes; therefore, this 
suggestion is out of scope for the CoPs.
    Comment: A few commenters recommended reinforcing the importance of 
timely initiation of service by adopting an initiation of care measures 
in the HHVBP program.
    Response: The HHVBP is not within the scope of the HHA CoPs; 
therefore, we are not accepting this suggestion.

B. Long-Term Care (LTC) Requirements for Acute Respiratory Illness 
Reporting

1. Background
    Under sections 1866 and 1902 of the Act, providers of services 
seeking to participate in the Medicare or Medicaid program, 
respectively, must enter into an agreement with the Secretary or the 
State Medicaid agency, as appropriate. Long-term care (LTC) facilities 
seeking to be Medicare and Medicaid providers of services must be 
certified as meeting Federal participation requirements. LTC facilities 
include skilled nursing facilities (SNFs) for Medicare and nursing 
facilities (NFs) for Medicaid. The Federal participation requirements 
for SNFs, NFs, and dually certified facilities, are set forth in 
sections 1819 and 1919 of the Act and codified in the implementing 
regulations at 42 CFR part 483, subpart B.
    Sections 1819(d)(3) and 1919(d)(3) of the Act explicitly require 
that LTC facilities develop and maintain an infection control program 
that is designed, constructed, equipped, and maintained in a manner to 
protect the health and safety of residents, personnel, and the general 
public. In addition, sections 1819(d)(4)(B) and 1919(d)(4)(B) of the 
Act explicitly authorize the Secretary to issue any regulations he 
deems necessary to protect the health and safety of residents. 
Continuous and systematic collection of data is an essential component 
of any infection control program, as the data provides information 
about potential health threats and enables prevention planning to 
mitigate severe health outcomes. LTC facility residents are vulnerable 
to infection from SARS-CoV-2 because of chronic health conditions, 
immunosenesence, and residence in a communal living setting. 
Vaccination provides protection against infection but does not 
eliminate the risk of acquiring SARS-CoV-2. Epidemiologic data from the 
CDC's National Healthcare Safety Network (NHSN) indicate that weekly 
COVID-19 cases continue to follow the general surge patterns of 2020 to 
2023, despite the vaccination status of the nursing home population. 
Additionally, the U.S. population remains at risk of increased 
infection incidence and adverse outcomes as additional SARS-CoV-2 
strains continue to emerge, and immunity induced by COVID-19 vaccines 
wane. As such, in alignment with the sections 1819(d)(3), 1919(d)(3), 
1819(d)(4)(B), and 1919(d)(4)(B) of the Act, we proposed to establish 
the ongoing collection of a set of data elements necessary to quickly 
identify threats to resident health and safety and initiate requisite 
responses.
    Infection prevention and control in LTC facilities was especially 
important during the COVID-19 PHE. Under the explicit instructions of 
Congress, existing regulations at Sec.  483.80 require facilities to, 
among other things, establish and maintain an infection prevention and 
control program (IPCP) designed to provide a safe, sanitary, and 
comfortable environment and to help prevent the development and 
transmission of communicable diseases and infections. The COVID-19 PHE 
placed enormous strain on the Nation's healthcare systems, requiring 
LTC facilities nationwide to take extraordinary measures in the face of 
staff shortages, and the scarcity of personal protective equipment 
(PPE) and critical supplies. Protecting residents in these 
circumstances demanded that we have better visibility and data on the 
spread and impact of COVID-19 in the Nation's LTC facilities. In 
response, CMS issued an evolving series of requirements to obtain those 
data through several interim final rules with comment period (IFCs) 
during the height of the PHE and subsequent final rules to support 
ongoing efforts to monitor and protect residents against COVID-19. When 
the CDC started collecting COVID-19 case data on a national scale in 
LTC facilities we began to understand the epidemiological trends of 
COVID-19 disease in LTC facility residents. The data highlighted how 
LTC facilities played a large role in viral transmission and that LTC 
facility residents were disproportionally impacted by COVID-19 compared 
to community dwelling adults. Even after the end of the PHE, national 
data collected in LTC facilities has shown that LTC facility residents 
continue to be impacted by COVID-19 at higher rates than older adults 
in the community and are more likely to develop severe outcomes. 
Continuing to understand trends of COVID-19 and other significant 
respiratory diseases (for example, RSV, Influenza) in the LTC facility 
population is critical to understanding the burden of respiratory 
viruses on the country.
    First, on May 8, 2020, we issued a IFC titled ``Medicare and 
Medicaid Programs, Basic Health Program, and Exchanges; Additional 
Policy and Regulatory Revisions in Response to the COVID-19 Public 
Health Emergency and Delay of Certain Reporting Requirements for the 
Skilled Nursing Facility Quality Reporting Program'' (85 FR 27550), 
which revised the infection prevention and control requirements for LTC 
facilities to more effectively respond to the specific challenges posed 
by the COVID-19 pandemic. Specifically, this May 2020 IFC added 
provisions to require facilities to electronically report information 
related to confirmed or suspected COVID-19 cases to the Centers for 
Disease Control and Prevention (CDC) and required facilities to inform 
residents and their representatives of confirmed or suspected COVID-19 
cases in the facility among residents and staff.
    Second, on September 2, 2020, we issued a IFC titled ``Medicare and 
Medicaid Programs, Clinical Laboratory Improvement Amendments (CLIA), 
and Patient Protection and Affordable Care Act, Additional Policy and 
Regulatory Revisions in Response to the COVID-19 Public Health 
Emergency'' (85 FR 54873). This September 2020 IFC set out provisions 
regarding testing for COVID-19 in LTC facilities, including 
documentation requirements and protocols specifying actions to be taken 
if a resident or staff member tests positive. On May 13, 2021, we 
issued another IFC titled ``Medicare and Medicaid Programs; COVID-19 
Vaccine Requirements for Long-Term Care (LTC) Facilities and 
Intermediate Care Facilities for Individuals with Intellectual 
Disabilities (ICFs-IID) Residents, Clients, and Staff'' (86 FR 26306), 
which further revised the infection control requirements that LTC 
facilities and intermediate care facilities for individuals with 
intellectual disabilities (ICFs-IID) must meet to participate in the 
Medicare and Medicaid programs. This May 2021 IFC aimed to reduce the 
spread of SARS-CoV-2 infections, the virus that causes COVID-19, by 
requiring education about COVID-19 vaccines for LTC facility residents, 
ICF-IID clients, and staff serving both populations, and by requiring 
that such vaccines, when available, be offered to all residents, 
clients, and staff. It also required LTC facilities to report COVID-19 
vaccination status of residents and staff to CDC.
    To retain the data reporting requirements after the end of the PHE, 
on November 9, 2021, we subsequently published a final rule titled ``CY 
2022

[[Page 88459]]

Home Health Prospective Payment System Rate Update; Home Health Value-
Based Purchasing Model Requirements and Model Expansion; Home Health 
and Other Quality Reporting Program Requirements; Home Infusion Therapy 
Services Requirements; Survey and Enforcement Requirements for Hospice 
Programs; Medicare Provider Enrollment Requirements; and COVID-19 
Reporting Requirements for Long-Term Care Facilities'' (86 FR 62440, 
62421), which finalized the COVID-19 data reporting requirements from 
the May 2020 and May 2021 IFCs. Specifically, in this November 2021 
final rule, we revised the requirements at Sec.  483.80(g)(1)(i) 
through (ix), to reduce the burden on the LTC facilities by allowing 
for a reduced frequency of reporting (weekly unless the Secretary 
specified a lesser frequency) and modified the specific data elements 
to be reported. The November 2021 final rule stated that until December 
31, 2024, facilities would be required to report electronically, in a 
standardized format specified by the Secretary, information on 
suspected and confirmed COVID-19 infections among residents and staff, 
including residents previously treated for COVID-19, total deaths and 
COVID-19 deaths among residents and staff, personal protective 
equipment and hand hygiene supplies in the facility, ventilator 
capacity and supplies available in the facility, resident beds and 
census, access to COVID-19 testing while the resident is in the 
facility, and staffing shortages. In addition, on an ongoing basis with 
no sunset date, facilities are required to report information on 
resident and staff vaccination status for COVID-19 (86 FR 62421).
    Finally, on June 5, 2023, we issued a final rule titled ``Medicare 
and Medicaid Programs; Policy and Regulatory Changes to the Omnibus 
COVID-19 Health Care Staff Vaccination Requirements; Additional Policy 
and Regulatory Changes to the Requirements for LTC Facilities and ICF-
IIDs to Provide COVID-19 Vaccine Education and Offer Vaccinations to 
Residents, Clients, and Staff; Policy and Regulatory Changes to the LTC 
Facility COVID-19 Testing Requirements'' (88 FR 36485).\114\ This June 
2023 final rule removed expired language addressing COVID-19 testing 
requirements issued in the September 2020 IFC, withdrew requirements 
mandating COVID-19 vaccinations for staff (see 86 FR 61555 for details 
regarding the IFC that issued the requirements \115\), and finalized 
requirements issued in the May 2021 IFC for facilities to provide 
education about vaccines and to offer COVID-19 vaccines to residents 
and staff.
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    \114\ June 2023 Final Rule. https://www.govinfo.gov/content/pkg/FR-2023-06-05/pdf/2023-11449.pdf.
    \115\ COVID-19 Health Care Staff Vaccination Interim Final Rule. 
https://www.federalregister.gov/documents/2021/11/05/2021-23831/medicare-and-medicaid-programs-omnibus-covid-19-health-care-staff-vaccination.
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2. The Benefits of and Ongoing Need for LTC Facility Respiratory 
Illness and Vaccination Data
    There are over 1.3 million older adults aged 65 years and older 
living in LTC facilities in the United States; and while LTC facility 
residents make up less than 0.5 percent of the population in the U.S., 
they were estimated to account for between 23 percent and 40 percent of 
deaths due to COVID-19 in the first two years of the COVID-19 
PHE.116 117 Older residents are at greater risk for both 
developing COVID-19 and other respiratory illnesses (for example, 
influenza, RSV) and for developing a protracted course of disease.\118\ 
Age-associated changes in immune function (that is, immunosenecense) 
can increase susceptibility to infection and decrease response to 
vaccination. Additionally, older adults often have multiple co-
morbidities leading to increased morbidity and mortality when coupled 
with a respiratory tract infection.\119\ The congregate setting of LTC 
facilities can also increase risk of disease transmission given the 
proximity of residents. In addition, providing care for residents often 
involves close-contact activities (for example, dressing, bathing) and 
the same health care personnel provide care to residents across 
different rooms and shared spaces. This readily facilitates 
transmission of respiratory viruses in this setting.\120\ Furthermore, 
LTC facility staffing shortages and consistent staff turnover, that are 
ever-present, but were greatly exacerbated during the COVID-19 PHE, 
make it even more challenging to provide quality care and to implement 
infection practices effectively and consistently, demonstrating the 
need for timely and actionable surveillance.\121\
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    \116\ Grabowski DC, Mor V. Nursing Home Care in Crisis in the 
Wake of COVID-19. JAMA. 2020;324(1):23. doi:10.1001/jama.2020.8524.
    \117\ Chidambaram P. Over 200,000 Residents and Staff in Long-
Term Care Facilities Have Died From COVID-19. Kaiser Family 
Foundation. Published online February 3, 2022. https://www.kff.org/policy-watch/over-200000-residents-and-staff-in-long-term-care-facilities-have-died-from-covid-19/.
    \118\ The New York Times. Nearly One-Third of U.S. Coronavirus 
Deaths Are Linked to Nursing Homes. https://www.nytimes.com/interactive/2020/us/coronavirus-nursing-homes.html. Published June 
1, 2021.
    \119\ Vital and Health Statistics, Series 3, Number 47 (cdc.gov) 
(https://www.cdc.gov/nchs/data/series/sr_03/sr03-047.pdf).
    \120\ Morbidity and Mortality Weekly Report (MMWR), Rates of 
COVID-19 Among Residents and Staff Members in Nursing Homes--United 
States, May 25-November 22, 2020 (cdc.gov) (https://www.cdc.gov/mmwr/volumes/70/wr/pdfs/mm7002e2-H.pdf).
    \121\ Infection prevention and control in nursing homes during 
COVID-19: An environmental scan--PMC (nih.gov) (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8810224/).
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    The COVID-19 PHE highlighted the value and potential utility of 
greater integration between public health and health care, particularly 
when data are available to direct collaborative actions that support 
patient, resident, and public health and safety. Data from health care 
providers, including LTC facilities, remain a key driver to identify 
and respond to patient, resident, and public health threats, yet health 
care and public health data systems have long persisted on separate, 
often poorly compatible tracks.\122\ The COVID-19 PHE also highlighted 
the importance of taking a broader view of patient and resident 
safety--one that recognizes patient and resident safety is determined 
not only by what is happening at the bedside, but also what is 
happening, in the facility as a whole, in neighboring facilities (for 
example, individuals moving between hospitals and LTC facilities and 
health care providers working in multiple facilities), and across the 
region, State, and county. The value of this broader view was 
particularly evident from the experience of LTC facilities, where 
systematic communicable disease and vaccination surveillance had never 
been integrated.
---------------------------------------------------------------------------

    \122\ Vital and Health Statistics, Series 3, Number 47 (cdc.gov) 
(https://www.cdc.gov/nchs/data/series/sr_03/sr03-047.pdf).
---------------------------------------------------------------------------

    For the first time, during the COVID-19 PHE, the nation had a real-
time comprehensive picture of a disease, its vaccine, and its impact in 
the nearly 16,000 U.S. LTC facilities because of data reported to the 
CDC's NHSN application. Ultimately, access to this information proved 
critical to providing resources and supporting coordinated action by 
facilities, health systems, communities and jurisdictions in responding 
to the PHE and protecting the health, safety and lives of LTC facility 
residents. The resources made available during the PHE response helped 
build resilience in some parts of the health care system, but the 
pandemic also exacerbated sources of fragility that continue to leave 
the United States underprepared to respond to surges--even relatively 
typical ones. COVID-19 and other respiratory illness

[[Page 88460]]

case, hospitalization, and vaccination data together provide critical 
situational awareness for regional and State leadership to inform a 
national strategy in response to the ongoing public health threat that 
respiratory illnesses including COVID-19 pose to residents.
    In the proposed rule, we provided a detailed discussion regarding 
the data produced by the respiratory illness reporting requirements for 
LTC facilities and how the insight provided by the data collected 
positively impacted resident health and safety by guiding actions to 
reduce the prevalence of respiratory illnesses through enhanced 
planning, technical assistance, resource allocation, and coordination 
at the facility, local, State, and Federal levels. We encourage readers 
to refer to the proposed rule for this detailed discussion (89 FR 
55404-55406).
3. Provisions of the Proposed Regulations and Analysis and Response to 
Public Comments
    In response to the proposed rule, we received 73 total comments 
from industry commenters, such as national associations, leadership, 
and facility staff. We received very few comments from advocacy 
organizations and no comments from anyone identifying themselves as 
residents or family advocates. In this final rule, we provide a summary 
of the proposed provisions, a summary of the public comments received, 
and our responses to them, and an explanation for changes in the 
policies we are finalizing.
a. Continuation of Respiratory Illness Reporting for LTC Facilities
    Given the value of respiratory illness and vaccination reporting 
during the COVID-19 PHE in supporting resident health and safety, we 
considered the continued utility of LTC facility respiratory illness 
data to monitor and protect residents against respiratory illnesses and 
the ongoing need for such data in the ``new normal'' of diverse 
respiratory disease threats. While the COVID-19 PHE has ended, SARS-
CoV-2 continues to circulate throughout the globe and although epidemic 
waves are less severe than those of 2020 through early 2022, there was 
no epidemiologic bright line associated with the end of the PHE. While 
COVID-19 hospital admissions were modestly lower in January 2024 than 
they were at the July 2022 or December 2022 peaks,\123\ adults 65 years 
and older represented more than half of COVID-19 hospitalizations 
during October 2023 to December 2023.\124\ Additionally, during the 
2023-2024 fall/winter respiratory virus season, COVID-19-associated 
hospitalizations among LTC facility residents peaked at a weekly rate 
that was more than eight times higher than the peak weekly rate among 
all U.S. adults aged >=70 years.\125\ At the same time, other 
respiratory viruses have also seen a resurgence, and the moderate 
COVID-19 burden coinciding with resurgent influenza and RSV has led to 
an overall hospitalization burden larger than observed during severe 
influenza and RSV seasons prior to the COVID-19 pandemic.\126\
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    \123\ https://covid.cdc.gov/covid-data-tracker/#trends_weeklyhospitaladmissions_select_00.
    \124\ CDC COVID Data Tracker: Hospital Admissions (https://covid.cdc.gov/covid-data-tracker/#datatracker-home).
    \125\ Franklin D, Barbre K, Rowe TA, Reses HE, Massey J, Meng L, 
Dollard P, Dubendris H, Stillions M, Robinson L, Clerville JW, 
Jacobs Slifka K, Benin A, Bell JM. COVID-19 vaccination coverage and 
rates of SARS-CoV-2 infection and COVID-19-associated 
hospitalization among residents in nursing homes. MMWR Morb Mortal 
Wkly Rep 2024;73:339-344. DOI: https://dx.doi.org/10.15585/mmwr.mm7315a3.
    \126\ Respiratory Disease Season Outlook (cdc.gov) (https://www.cdc.gov/forecast-outbreak-analytics/about/season-outlook.html).
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    The elevated risks of respiratory viruses in the post-PHE era 
present ongoing threats, both direct and indirect, to resident health 
and safety. As such, we proposed to continue some of the reporting 
requirements finalized in November 2021 and set to expire in December 
2024. Specifically, we proposed to revise the infection prevention and 
control requirements for LTC facilities to extend reporting in NHSN for 
a limited subset of the current COVID-19 elements and also require 
reporting for data related to influenza and RSV.
    Specifically, we proposed to replace the existing reporting 
requirements for LTC facilities at Sec.  483.80(g)(1)(i) through (ix) 
and (g)(2) with new requirements to report information addressing 
respiratory illnesses. Beginning on January 1, 2025, we proposed to 
require facilities to electronically report information about COVID-19, 
influenza, and RSV in a standardized format and frequency specified by 
the Secretary. We proposed to continue weekly reporting through the 
CDC's NHSN. To the extent to be determined by the Secretary, through 
this rulemaking cycle, we proposed that the data elements for which 
reporting would be required include all of the following:
     Facility census (defined as the total number of residents 
occupying a bed at this facility for at least 24 hours during the week 
of data collection).
     Resident vaccination status for a limited set of 
respiratory illnesses including but not limited to COVID-19, influenza, 
and RSV.
     Confirmed resident cases of a limited set of respiratory 
illnesses including but not limited to COVID-19, influenza, and RSV 
(overall and by vaccination status).
     Hospitalized residents with confirmed cases of a limited 
set of respiratory illnesses including but not limited to COVID-19, 
influenza, and RSV (overall and by vaccination status).
    Comment: A few commenters expressed support for our proposal to 
extend the requirements for respiratory illness reporting in LTC 
facilities. These commenters stated that sustained data collection and 
reporting provides valuable information for guiding infection control 
interventions; keeping LTC facility residents, family members, and 
staff safe; and directing resources where they are most needed. A 
commenter specifically expressed support for including other 
respiratory illnesses in the required NHSN reporting. A commenter 
stated that understanding health related social needs and demographic 
information may be helpful in addressing health inequities.
    Response: We thank commenters for their support of LTC facility 
acute respiratory illness data reporting to NHSN. The Infection Control 
requirements at Sec.  483.80 are a comprehensive set of requirements 
that include an infection prevention and control plan (IPCP) based upon 
the facility assessment as set forth in Sec.  483.71. Consistent data 
on COVID-19, influenza, and RSV is essential for infection control 
efforts to protect the health and safety of residents as well as 
facility staff. We acknowledge that every LTC facility is different, 
with different resident populations, varying types of acuity and 
medical needs, and resource challenges. As such, our goal to minimize 
the risk of severe illness, hospitalization and death from respiratory 
viruses is supported by situational awareness that occurs with data 
that can be analyzed on a regular frequency, easily available and acted 
upon.
    Comment: A commenter recommended requirements that LTC facilities 
include at least one full-time dedicated infection preventionist (IP) 
to support reporting and a robust IPCP.
    Response: We appreciate the recommendation that LTC facilities use 
at least one full-time dedicated IP. Existing provisions at Sec.  
483.80(b) require facilities to have an IP work at least part-time at 
the facility. Additionally, if the facility assessment identifies the 
need for additional

[[Page 88461]]

resources above the minimum requirement of a part time IP position, 
then the facility should staff to the appropriate level to care for its 
resident population. We believe that these existing requirements set 
forth a feasible and achievable minimum health and safety standard that 
supports infection prevention and control, while also considering the 
differences and varying needs of all of the LTC facilities that must 
comply with these minimum health and safety requirements.
    Comment: Another commenter supported required respiratory illness 
data reporting and recommended establishing policies to ensure that 
resident privacy is protected.
    Response: We appreciate the commenter's support for acute 
respiratory illness data reporting as well as the recommendation to 
ensure that residents' privacy is protected. Existing provisions at 
Sec.  483.10(h), ''Privacy and Confidentiality,'' require LTC 
facilities to ensure and respect a resident's right to personal privacy 
and the confidentiality of their personal and medical records. This 
includes but is not limited to using appropriate administrative, 
physical and technical safeguards to ensure confidentiality, integrity 
and security of personal and medical records. Regular training for LTC 
facility staff on privacy and security best practices is essential. 
Also, Sec.  483.10(g), ``Resident rights'', requires LTC facilities to 
respect a resident's right to privacy in communications. This includes 
mail, letters, packages and other materials. The LTC facility must also 
ensure that residents' have reasonable access and privacy in electronic 
communications, including email, video communications and internet 
access for research. Hence, we believe the LTC facility is already 
required and should have policies to ensure resident privacy of their 
medical records, including respiratory illness reporting based on these 
existing requirements.
    Comment: Many commenters recommended that CMS revise the frequency 
of NHSN reporting to monthly or quarterly or, in some cases, annually 
to reduce the administrative burden associated with the proposed 
requirement. A few commenters stated that weekly reporting is a 
pandemic level frequency for reporting and stated that this is no 
longer appropriate. Other commenters suggested reporting during peak 
respiratory virus season (that is, fall and winter). A few commenters 
suggested that facilities report to NHSN only in the event of an 
outbreak. A few commenters recommended allowing reporting of snapshot 
data for the week instead of cumulative data.
    Response: We thank the commenters for their feedback. Elevated 
risks of respiratory viruses in the post-PHE era present ongoing 
threats and there will be more burdensome respiratory virus seasons and 
periodic surges for the foreseeable future that threaten the health and 
safety of LTC facility residents.\127\ In response, public health 
agencies, such as the CDC, have shifted prevention and control 
strategies from a focus on specific viruses to an approach that 
addresses the threats presented by the broader respiratory virus 
season, including focused efforts to mitigate impacts on nursing home 
residents and staff.\128\ Likewise, we believe it is vital to maintain 
national surveillance of these emerging and evolving respiratory 
illnesses as a means of guiding infection control interventions to keep 
residents safe. To achieve this the most useful data are those that are 
timely and actionable. It is in the best interests of LTC facility 
residents to protect them by continuing year-round surveillance to 
monitor for respiratory viruses. Such surveillance will provide 
actionable data for LTC facilities, healthcare quality improvement 
organizations, and public health agencies.
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    \127\ Respiratory Disease Season Outlook (cdc.gov) (https://www.cdc.gov/forecast-outbreak-analytics/about/season-outlook.html).
    \128\ See https://www.cdc.gov/respiratory-viruses/ and 
data summaries of respiratory virus burden at https://www.cdc.gov/respiratory-viruses/data-research/dashboard/snapshot.html and 
https://www.cdc.gov/respiratory-viruses/whats-new/track-hospital-capacity.html.
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    The proposed requirements are scaled back and streamlined in 
comparison to the current post COVID-19 PHE requirements. As such, the 
CDC has combined the respiratory illness reporting fields in NHSN and 
created one simplified reporting form (a reduction from four forms) to 
support the data collection. For additional context, this streamlined 
data collection will eliminate over 30 data fields that LTC facilities 
will need to address in the NHSN system.
    Continuing the collection of the minimal necessary data for weekly 
data reporting to NHSN will maintain a level of situational awareness 
that will protect resident health and safety, while reducing reporting 
burden on LTC facilities. Weekly reporting allows for public reporting 
in real time and on a regularly occurring basis. This ensures that a 
variety of entities across the local, State, and Federal levels (such 
as, LTC facilities and associations, CDC, Quality Innovation Network-
Quality Improvement Organizations (QIN-QIOs), state and local health 
departments) can monitor data with a minimal data lag and allow for 
quicker, direct response efforts to outbreaks among LTC facility 
residents.
    Furthermore, we are not collecting only a ``snapshot'' of data, as 
suggested, because the required data to be reported has been 
streamlined to represent the minimum necessary data and there is a need 
to keep the collection period consistent (Monday through Sunday) to 
ensure the reliability of the data. Facilities will submit data through 
the NHSN reporting system once per week, representing cumulative 
vaccination coverage, new positive tests, and new hospitalizations that 
occurred during the week of reporting. Therefore, we believe that a 
weekly reporting frequency at this time is appropriate. However, we 
note that the requirements we are finalizing allow the Secretary the 
discretion to revise the frequency of reporting, and we will continue 
to monitor the utility of the reporting requirements and changing needs 
for the data collection.
    Comment: Many commenters recommended not finalizing proposals 
related to continued reporting of respiratory viruses through the NHSN 
and recommended that CMS allow the existing requirements for NHSN 
reporting to end on December 31, 2024, as currently provided for at 
Sec.  483.80(g). Commenters indicated that the continuation of data 
collection would divert resources from providing direct patient care 
and other important initiatives, such as quality improvement. Many 
commenters stated that the proposed reporting requirements are too time 
consuming and therefore would create administrative burden on LTC 
facilities that may outweigh the benefits of data reporting. Commenters 
were concerned that this reporting is resource intensive and would 
require LTC facilities to increase staffing levels to comply with all 
the steps of data collection, verification, and submission (including 
addressing a changing population of staff and residents) and stated 
that increasing staffing would be difficult because LTC facilities are 
currently facing staffing challenges. Some commenters specifically 
highlighted the potential burden on small facilities with minimal 
staff. A few commenters stated that data collection within the NHSN 
will not lead to improved care for residents and that the benefits of 
reporting that were seen during the PHE (including PPE allocations, 
strike teams, and test kit allocations) are no longer associated with 
NHSN reporting.

[[Page 88462]]

    Response: We appreciate the feedback from these commenters; 
however, timely data reported on acute respiratory illnesses is 
essential to help guide targeted efforts to reduce severe illnesses and 
deaths among the resident population. A data driven approach will guide 
infection prevention and control interventions and LTC facility 
operations that directly relate to resident health and safety. As 
discussed previously, we want to emphasize that the requirements we are 
finalizing are scaled back and streamlined in comparison to the current 
post COVID-19 PHE requirements. For context, the streamlined data 
collection will reduce the number of NHSN forms from 4 to 1 and 
eliminate over 30 data fields that LTC facilities will need to address 
in the system. Therefore, we are finalizing the proposed policy, which 
will continue the collection of the minimal necessary data needed to 
maintain a level of situational awareness that we believe will protect 
resident health and safety in LTC facilities across the country, while 
reducing reporting burden on those facilities.
    Comment: Many commenters stated that the proposed reporting 
requirements would require LTC facilities to report duplicative data 
through the CDC's NHSN. Commenters stated that relevant COVID-19 
reporting has been incorporated into other systems and programs, and 
other respiratory illnesses are collected through the Minimum Data Set 
(MDS). Commenters also mentioned that infection data are already 
reported through other mandatory mechanisms such as reporting 
surveillance data to local authorities, public health agencies or 
departments of health as part of infection control requirements, 
including clusters of respiratory virus symptoms and information about 
confirmed cases. Commenters stated that because of these other data 
collection channels, requiring continued reporting through the NHSN 
would be unnecessary and duplicative, and recommended that CMS and CDC 
coordinate with public health agencies to access the data. A few 
commenters also noted that NHSN has separate guidelines for reporting 
data which are different from the guidelines for reporting the same 
data via the Minimum Data Set (MDS), which increases administrative 
reporting burden. A few commenters stated that data submission through 
MDS is preferable because these data can be linked to resident-specific 
demographic and socioeconomic data and can be used to inform care 
plans. Some commenters recommended only requiring LTC facilities to 
report on items not reported via MDS. A commenter recommended reporting 
the data through a system similar to internet Quality Improvement and 
Evaluation System (iQIES) that would automatically pull the data. 
Lastly, a few commenters also noted that with the release of updated 
public health guidance in March 2024, CDC began shifting to a more 
standardized approach toward reporting on the incidence of respiratory 
viruses and recommended that CMS align nursing home requirements with 
this guidance. A commenter recommended that CMS convene a task force to 
study what high value data should continue to be collected from LTC 
facilities and consider adding to existing reporting platforms.
    Response: We acknowledge that differing mechanisms for reporting 
some of the proposed respiratory data elements exist beyond NHSN, such 
as reporting through MDS. However, while there is some overlap between 
NHSN and MDS collections, specifically resident vaccination data, 
streamlined data regarding acute respiratory illnesses including COVID-
19, influenza, and RSV, as we proposed, are not currently captured in 
MDS. CMS and the CDC are committed to collecting the minimum data 
fields necessary to inform public health response and protect LTC 
facility residents. NHSN reporting provides useful data that are timely 
and actionable in real time on a routine cadence (weekly), unlike the 
MDS, which is collected at longer intervals that are dictated by 
reporting requirements unrelated to acute respiratory illnesses. An MDS 
must be completed for each resident upon admission, and then at regular 
intervals, typically every 3 months, or whenever there is a significant 
change in the resident's condition (see Sec.  483.20, ``Resident 
assessment''). The timing of MDS data collection and reporting does not 
support facility-level acute respiratory illness situational awareness, 
since minimal data lag is needed to inform response efforts. Technical 
assistance and resource allocation may be delayed or omitted due to 
reduced or dated available information.
    We also acknowledge that varying State health departments may also 
have reporting requirements for respiratory illness data. However, we 
believe that there is value in collecting this information at the 
Federal level. The NHSN data reports are accessed by State health 
departments to provide actionable data. The CDC monitors downloads of 
these reports and provides ongoing support to States and facilities 
with these data, showing that the data are actively being used and are 
found to be valuable to direct response and vaccination efforts to the 
LTC facilities that most need support and intervention. For example, 
publicly available national vaccination data are critical for decision 
making, targeting outreach for vaccination campaigns efforts, insights 
into vaccination disparities and for vaccine effectiveness 
studies.\129\ NHSN data was used by the CDC and QIOs to contact 
facilities with high vaccination coverage in order to understand the 
successful strategies they employed and promote these strategies to 
other LTC facilities via webinars. Moreover, information from this 
outreach was used to identify and respond to vaccination barriers by 
creating tools and resources, such as the Healthcare Provider Toolkit, 
to help LTC facilities educate their staff, residents, and families to 
remove barriers to vaccination.
---------------------------------------------------------------------------

    \129\ Wong E, Barbre K, Wiegand RE, Reses HE, Dubendris H, 
Wallace M, Dollard P, Edwards J, Soe M, Meng L, Benin A, Bell JM. 
Effectiveness of Up-to-Date COVID-19 Vaccination in Preventing SARS-
CoV-2 Infection Among Nursing Home Residents--United States, 
November 20, 2022-January 8, 2023. MMWR Morb Mortal Wkly Rep. 2023 
Jun 23;72(25):690-693. doi: 10.15585/mmwr.mm7225a4. PMID: 37347711; 
PMCID: PMC10328477.
---------------------------------------------------------------------------

    As noted previously, with this final rule we have streamlined data 
reporting to reduce burden, subsequently the CDC reduced reporting 
burden by creating a simplified and more efficient reporting form. 
Respiratory illness reporting fields for COVID-19, influenza and RSV 
are combined into a single data entry form (previously there were 
four), providing a significantly simplified and improved user 
experience. The CDC has invested in enhanced user support, an improved 
helpdesk ticket response system and training tailored to the LTC 
community to support the use of NHSN. In addition, there are some 
projects underway with LTC industry stakeholders to modernize data 
collection as well as improving interoperability with State 
Immunization Information Systems.
    Comment: A few commenters did not support continued respiratory 
virus reporting through the NHSN because of technical challenges with 
the NHSN. Several commenters noted that the NHSN system experiences 
regular technical issues and lags in service that would be made worse 
by the continued and additional reporting by facilities. These 
commenters stated that the NHSN is slow and there are lengthy delays 
even for small amounts of data. These commenters also expressed concern 
that

[[Page 88463]]

the NHSN help desk has long wait times and that the process for staff 
to gain initial access to the system is lengthy. Some commenters stated 
that there are frequent technical issues with NHSN which could lead 
facilities to be non-compliant in data reporting through no fault of 
their own. A few commenters expressed concerns about privacy and 
sharing sensitive information that could be at risk due to issues such 
as data breaches and unauthorized access. A commenter stated that by 
adopting these requirements through the CoPs, CMS creates a risk that 
facilities may become non-compliant with the CoPs due to NHSN technical 
issues.
    Response: We appreciate the comments regarding technical challenges 
with the NHSN. Through its data modernization efforts, CDC continues to 
work to strengthen the support available to the LTC community. The CDC 
publishes regularly scheduled updates and associated trainings, for 
which they notify the LTC community by email blasts and newsletters. 
Training webinars are available for replay and can be accessed in the 
NHSN section of the CDC website.\130\ We understand the commenters' 
concerns about technical challenges regarding the reporting of the 
required information. These concerns about noncompliance due to NHSN 
technical issues could be mitigated with documentation of technical 
issues and the facility's communication with CDC to get issues 
corrected. CMS does not expect LTC facilities to be penalized for 
limitations to compliance that are outside of their control, and this 
has not been the approach taken by CMS regarding enforcement of the PHE 
COVID-19 reporting requirements or the current post-PHE reporting 
requirements.
---------------------------------------------------------------------------

    \130\ https://www.cdc.gov/nhsn/ltc/.
---------------------------------------------------------------------------

    However, existing requirements at Sec.  483.10(h)(3) set out the 
facility's obligation to protect each resident's right to secure and 
confidential personal and medical records. CMS expects all LTC 
facilities to protect resident data and information. Data breaches and 
unauthorized access are important concerns that the facility can 
mitigate by establishing clear and strict data security policies; 
limiting physical and electronic access to resident data, regular 
training on privacy and sharing sensitive information; and using 
encryption and secure communication protocols. If a data breach or 
unauthorized access occurs that was or should have been within the LTC 
facility's control, CMS would evaluate the circumstances for the 
performance of that individual LTC facility. For example, if a LTC 
facility allowed access to resident medical records to personnel that 
had no legitimate reason for access to those records and unauthorized 
access occurred, CMS might cite the LTC facility. Data breaches can 
impact any entity, even the Federal Government, and we expect that LTC 
facilities will take the appropriate actions to correct and limit any 
damage or injury to residents from any data breach or unauthorized 
access to their medical or other personal information.
    Comment: Several commenters recommended that HHS invest in the 
infrastructure needed to make the voluntary sharing of important data 
on infectious diseases less burdensome. Some of these commenters stated 
that this would be particularly important for the PAC setting because 
of the relative lack of interoperable electronic health records (EHRs) 
across these facilities. A few of these commenters expressed concerns 
that establishing requirements for participation for respiratory 
illness data reporting may threaten Medicare participation, facility 
financial viability, and access to care. Several commenters suggested 
that CMS should work with state government, local health departments 
and the provider community to determine how best to share data across 
entities and what data elements are most valuable in responding to 
PHEs, thereby reducing redundancy and administrative burden. Many 
commenters recommended that CMS collaborate with state health agencies 
to access surveillance data reported by facilities to mitigate the need 
to report to multiple agencies. A few commenters suggested that NHSN be 
directed to obtain data from state agencies to reduce duplication of 
effort. Commenters also stated that reporting requirements vary across 
agencies and recommended aligning these requirements. A commenter 
specifically recommended using OSHA's upcoming Infection Disease 
Standard to standardize data collection for healthcare professionals, a 
group that the commenter stated was omitted from the proposed reporting 
requirement.
    Response: We thank commenters for their feedback on ways to make 
reporting less burdensome. The current lack of interoperability of 
electronic health records (EHRs) in the PAC setting makes it even more 
important to use the NHSN since it is set up to accept data that is 
collected, verified and submitted by all the LTC facilities across the 
country, whether they have an EHR system or not. We appreciate the 
support for transitioning to, and using, more modern, flexible 
approaches and networks that support data exchange between and across 
public health and healthcare institutions to modernize the public 
health information infrastructure. We also appreciate the suggestion 
that NHSN should obtain data from State agencies to reduce provider 
burden, however this suggestion is not viable for many reasons, 
including the lack of consistent definitions of data elements across 
States, the fact that all States do not require data submission of all 
data elements that are being finalized, and that States systems may not 
be set up to send data to NHSN in the manner that is most valuable for 
situational awareness.
    Regarding the omission of data collection for healthcare personnel, 
we note that we considered the utility of LTC facility respiratory 
illness data to monitor and protect residents against respiratory 
illnesses and the ongoing need for such data given the diverse 
respiratory disease threats. Currently, LTC facilities only report on 
staff vaccination status quarterly and we did not believe there was 
enough of a use case to support continued mandatory reporting of staff 
data. However, we note that at Sec.  483.80(g)(2)(i) we proposed that 
LTC facilities would need to report on relevant confirmed infections 
for staff in the event of a PHE. Furthermore, staff vaccination status 
is currently reported through the SNF Quality Reporting Program (QRP) 
under the SNF QRP measure ``COVID-19 Vaccination Coverage among 
Healthcare Personnel''.
    Comment: Several commenters asserted that they did not support 
continued reporting requirements because LTC facilities are the only 
healthcare setting that is still being required to report this data. 
Some of these commenters expressed that by only requiring this data for 
one narrow sample of the population (that is, residents of LTC 
facilities) CMS would not be able to track infections across the 
overall population.
    Response: We thank commenters for their feedback, however, we note 
that the assertion is incorrect. CMS finalized proposals for hospitals 
and CAHs to continue ongoing (that is outside of a PHE) reporting on 
data related to influenza, COVID-19, and RSV to NHSN. In addition, we 
finalized proposals for hospital and CAHs to report on additional data 
categories that could be required during the event of a declared PHE. 
These proposals were finalized on August 28, 2024, as part of the final 
rule titled ``Medicare and Medicaid Programs and the Children's Health 
Insurance Program; Hospital Inpatient Prospective Payment Systems for 
Acute Care Hospitals and the Long

[[Page 88464]]

Term Care Hospital Prospective Payment System and Policy Changes and 
Fiscal Year 2025 Rates; Quality Programs Requirements; and Other Policy 
Changes'' (89 FR 69913).\131\ The requirements for hospitals and CAHs 
will be effective on November 1, 2024, and we refer readers to the 
final rule for more detail.
---------------------------------------------------------------------------

    \131\ https://www.federalregister.gov/documents/2024/08/28/2024-17021/medicare-and-medicaid-programs-and-the-childrens-health-insurance-program-hospital-inpatient.
---------------------------------------------------------------------------

    Comment: A few commenters recommended that CMS align the decision 
on more detailed demographic data reporting requirements for LTC 
facilities with the decision finalized for acute inpatient hospitals 
and CAHs finalized in the FY 2025 inpatient PPS final rule. These 
commenters stated that the Federal standards for the collection of race 
and ethnicity are currently being revised, with a compliance deadline 
of October 2025 for Federal agencies to develop their plans to comply 
with these new standards and a deadline of March 2029 to come into full 
compliance. Commenters expressed concern that as these standards are 
being implemented, CMS could adopt a set of requirements that could 
swiftly change. A few commenters requested clarification on whether CMS 
is seeking to collect aggregate or patient-level data. Many commenters 
also stated that LTC facilities currently use MDS to collect 
information related to demographics and recommended not duplicating 
this data collection. These commenters did not support including race, 
ethnicity, and socioeconomic status in the respiratory virus reporting 
requirements because of concerns that this would increase the time 
needed for data collection and reporting.
    Response: We thank commenters for the information and perspectives 
on the collection and submission of demographic data. While we are not 
expanding the collection of demographic data at this time due to the 
need to further refine this concept and the January 1, 2025, effective 
date of this reporting requirement, we acknowledge that not collecting 
this data would represent a gap in epidemiological information. We 
believe that demographic data plays an important role in informing 
healthcare decisions that ultimately impact the health and safety of 
residents. We intend to continue to explore ways to facilitate and 
strengthen the collection of additional demographic data in the future.
    Comment: A commenter expressed concern that these proposed 
requirements were not proposed in the SNF PPS proposed rule. This 
commenter stated that HH PPS proposed rule is an inappropriate setting 
for LTC rulemaking and recommended that CMS only adopt policies that 
affect LTC facilities in rulemaking that applies to those facilities. 
This commenter also recommended adjusting payment rates for LTC 
facilities to accommodate the increased burden of reporting.
    Response: We note that issues related to payment policy are outside 
the scope of the health and safety standards and LTC requirements for 
participation. We appreciate the concern that some commenters expressed 
regarding the use of the home health prospective payment rule as the 
CMS regulatory vehicle to notify the public of our proposal for LTC 
acute respiratory illness data reporting. It is typical practice for 
CMS to leverage differing regulatory vehicles to issue our regulatory 
priorities, especially as it relates to the issuance of policy updates 
for the Medicare health and safety standards. For example, the current 
post-PHE COVID-19 reporting requirements were issued on November 9, 
2021, as part of the CY 2022 Home Health Prospective Payment System 
(PPS) final rule.\132\ The importance of the reporting requirements 
coupled with the December 2024 expiration of the current post-PHE 
COVID-19 reporting requirements at Sec.  483.80 necessitated the use of 
this regulatory vehicle as a viable option to communicate this action. 
We encourage readers to regularly review OMB's Unified Agenda \133\ and 
to sign up to receive email updates to get the latest information about 
your choice of CMS topics, but specifically timely information 
regarding activities and initiatives that may impact LTC facilities. 
Those interested can find a field at the bottom of CMS.gov to enter 
their email addresses and sign up for updates.\134\
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    \132\ 86 FR 62240; https://www.federalregister.gov/documents/2021/11/09/2021-23993/medicare-and-medicaid-programs-cy-2022-home-health-prospective-payment-system-rate-update-home.
    \133\ https://www.reginfo.gov/public/do/eAgendaMain.
    \134\ https://www.cms.gov/.
---------------------------------------------------------------------------

    Final Rule Action: We are finalizing our proposal to require 
ongoing respiratory illness reporting in a modified form as proposed. 
LTC facilities, in a standardized format and frequency specified by the 
Secretary, must electronically report information on acute respiratory 
illnesses, including influenza, SARS-CoV-2/COVID-19, and RSV, facility 
census (defined as the total number of residents occupying a bed at 
this facility for at least 24 hours during the week of data 
collection), resident vaccination status, confirmed resident cases, and 
hospitalized residents with confirmed cases.
b. Collection of Additional Data Elements During a PHE
    The COVID-19 PHE strained the healthcare system substantially, 
introducing new safety risks and negatively impacting patient and 
resident safety in the normal delivery of care. Data from the pandemic 
showed that the incidence of healthcare-associated infections would 
increase when COVID-19 hospitalizations were high,\135\ a feedback loop 
between increased stress on hospitals, LTC facilities, illness in the 
community, and patient and resident health and safety. Degradation in 
other measures of resident safety, including pressure ulcers and falls, 
further demonstrate how the strains associated with surge response 
adversely affect routine safety practices.136 137 
Specifically in LTC facilities, the significant adverse health impacts 
on residents caused by COVID-19 went far beyond the direct effects of 
COVD-19 morbidity and mortality.\138\ Given the unprecedented impacts 
of, and learnings derived from, the COVID-19 PHE, we believe that it is 
imperative to enhance preparedness and resiliency to improve health 
system responses to future threats, including pandemics that pose 
catastrophic risks to resident safety. As such, we proposed to require 
additional data reporting in the event of an acute respiratory illness 
PHE, or after the Secretary's determination that a significant threat 
of one exists.
---------------------------------------------------------------------------

    \135\ Continued increases in the incidence of healthcare-
associated infection (HAI) during the second year of the coronavirus 
disease 2019 (COVID-19) pandemic [verbar] Infection Control & 
Hospital Epidemiology [verbar] Cambridge Core; https://www.nejm.org/doi/full/10.1056/NEJMp2118285; The impact of coronavirus disease 
2019 (COVID-19) on healthcare-associated infections in 2020: A 
summary of data reported to the National Healthcare Safety Network--
PubMed (nih.gov) (https://pubmed.ncbi.nlm.nih.gov/34473013/); Impact 
of COVID-19 pandemic on central-line-associated bloodstream 
infections during the early months of 2020, National Healthcare 
Safety Network--PubMed (nih.gov) (https://pubmed.ncbi.nlm.nih.gov/33719981/).
    \136\ Falls Risk in Long-Term Care Residents With Cognitive 
Impairment: Effects of COVID-19 Pandemic--PubMed (nih.gov) (https://pubmed.ncbi.nlm.nih.gov/38104633/).
    \137\ https://www.nejm.org/doi/full/10.1056/NEJMp2118285.
    \138\ The Adverse Effects of the COVID-19 Pandemic on Nursing 
Home Resident Well-Being--PMC (nih.gov) (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7980137/).
---------------------------------------------------------------------------

    Specifically, we proposed that during a declared national, State, 
or local PHE for a respiratory infectious disease (or if the Secretary 
determines a significant

[[Page 88465]]

threat for one exists) the Secretary may require facilities to report:
     Data up to a daily frequency without additional notice and 
comment rulemaking.
     Additional or modified data elements relevant to the PHE, 
including relevant confirmed infections among staff, supply inventory 
shortages, staffing shortages, and relevant medical countermeasures and 
therapeutic inventories, usage, or both.
     If the Secretary determines that an event is significantly 
likely to become a PHE for an infectious disease, the Secretary may 
require LTC facilities to report additional or modified data elements 
without notice and comment rulemaking.
    We invited comments on whether there should be limits to the data 
the Secretary can require without notice and comment rulemaking during 
a PHE, such as limits on the duration of additional reporting or the 
scope of the jurisdiction of reporting (that is, State or local PHEs). 
We also sought comments on whether and how the Secretary should still 
seek stakeholder feedback on additional elements during a PHE without 
notice and comment rulemaking and how HHS should notify LTC facilities 
of new required infectious disease data. Furthermore, we invited 
comments on the evidence HHS should provide to demonstrate that--(1) an 
event is ``significantly likely to become a PHE''; or (2) the increased 
scope of required data will be used to protect resident and community 
health and safety. We also invited comments on the utility and burden 
of specifically staffing and supply shortage data we propose to collect 
during national, State, or local PHE for a respiratory infectious 
disease (or if the Secretary determines a significant threat for one 
exists). Based on LTC facilities experience with the COVID-19 PHE, how 
could HHS collect this data specifically in a way that would be 
beneficial to LTC facilities?
    Comment: Many commenters did not support adopting a policy which 
would allow the Secretary to require reporting without going through 
notice and comment rulemaking because this would deny an opportunity 
for those impacted by a rule to offer feedback and advocate for 
changes. Some commenters also expressed concern that changing 
requirements during a PHE could lead to unintentional non-compliance. A 
few commenters expressed concerns about the lack of any legal standard 
for a ``significantly likely'' PHE and stated that there is no 
statutory or other authority allows the Secretary to change mandatory 
reporting requirements based on a ``significantly likely'' PHE. These 
commenters stated that the term PHE has a specific meaning in statute 
and regulation, and the declaration of a PHE authorizes CMS to exercise 
significant flexibilities and powers intended to expedite the 
regulatory process. The commenters expressed concern regarding the 
precedent of CMS or any other Federal agency using such a vague 
categorization to circumvent the notice and comment rulemaking process. 
A commenter stated that the ability to waive notice and comment 
requirements only applies to voluntary information collections during a 
declared PHE and therefore, under the Paperwork Reduction Act (PRA) the 
Director of OMB would be required to review and approve any waiver of 
notice and comment rulemaking.
    Response: We appreciate the responses regarding our proposal for 
reporting respiratory illness data during a PHE. We understand the need 
for clarity when PHE-related data reporting is required. At the time of 
a PHE declaration, clarification and guidance from the Secretary will 
occur so that LTC facilities will know what related data elements are 
activated for reporting. We expect to use a communication mechanism, 
such as a Quality Safety and Oversight Memo, that is readily available 
to the public, nationally accessible, and familiar to stakeholders, to 
ensure clarity and access to necessary information. Protecting 
residents during a PHE demands that we have better visibility and data 
on the spread and impact of an acute respiratory illness in the 
nation's LTC facilities. A PHE declaration signals that focused and 
timely actions are needed so that responses are actionable and 
appropriate. The time it would take for a notice and comment period 
would delay the reporting and analysis of data and subsequent 
interventions that promote health and safety in facilities.
    We recognize the concerns raised regarding the proposal to require 
increased PHE reporting in the likely event of a PHE. In response to 
the concerns raised we are withdrawing the proposal that the Secretary 
may require increased reporting in the event of a likely PHE. We 
encourage LTC facilities to use their required emergency preparedness 
plans and policies and procedures (Sec.  483.73) to promote readiness 
and actions that could reduce burden during a resource intense time 
(that is, during a PHE).
    Comment: Many commenters expressed concern that changing reporting 
requirements during a PHE or an event significantly likely to become a 
PHE could lead to excessive administrative burden with limited 
benefits. Some of these commenters stated that daily reporting would 
take time away from resident care and infection control efforts. Some 
commenters stated that reporting data during the COVID-19 PHE did not 
lead to improved resources (such as distribution of PPE) but that it 
did lead to facilities being blamed for their challenges in addressing 
the pandemic. A commenter recommended considering supportive outreach 
to facilities, such as by QIOs, during future PHEs or events 
significantly likely to become a PHE.
    Response: We thank the commenters for their concerns about 
increased data reporting during a PHE and the potential administrative 
burden with limited benefits. The best way targeted support can be 
provided during a PHE is to be aware of the what the facility needs. A 
data driven approach will ensure that LTC facilities, local and state 
health departments, CDC and HHS can identify trends so that mitigation 
strategies can be implemented quickly, and facilities can improve 
residents' health and safety and reduce the spread of illness. The CDC 
reduced reporting burden to facilities by streamlining reporting data 
entry forms, enhanced user support, has implemented an improved 
helpdesk ticket response system and increased staffing and training for 
addressing NHSN user issues. The QIOs can monitor data in almost real 
time (both the streamlined weekly data and the expanded data 
requirements during a PHE) with minimal data lag to direct response 
efforts to outbreaks among nursing home residents. Some examples of 
interventions made during the COVID PHE include community pharmacy 
vaccine clinics, vaccine education tools, testing kits and ad 
campaigns.
    Final Decision: We are finalizing as proposed our proposal to 
require additional reporting during a declared national, State, or 
local PHE for an acute infectious illness. We have withdrawn our 
proposal to require additional reporting if the Secretary determines 
that an event is ``significantly likely'' to become a PHE for an 
infectious disease. During a declared national, State, or local PHE for 
an acute infectious illness the Secretary may require reporting of data 
elements relevant to confirmed infections for staff, supply inventory 
shortages, staffing shortages, and relevant medical countermeasures and 
therapeutic inventories, usage, or both.

[[Page 88466]]

VII. Provider Enrollment--Provisional Period of Enhanced Oversight

A. Background

1. Overview of Medicare Provider Enrollment
    Section 1866(j)(1)(A) of the Act requires the Secretary to 
establish a process for the enrollment of providers and suppliers into 
the Medicare program. The overarching purpose of the enrollment process 
is to help confirm that providers and suppliers seeking to bill 
Medicare for services and items furnished to Medicare beneficiaries 
meet all applicable Federal and State requirements to do so. The 
process is, to an extent, a ``gatekeeper'' that prevents unqualified 
and potentially fraudulent individuals and entities from entering and 
inappropriately billing Medicare. Since 2006, we have undertaken 
rulemaking efforts to outline our enrollment procedures. These 
regulations are generally codified in 42 CFR part 424, subpart P 
(currently Sec. Sec.  424.500 through 424.575). They address, among 
other things, requirements that providers and suppliers must meet to 
enroll in Medicare.
    As outlined in Sec.  424.510, one such requirement is that the 
provider or supplier must complete, sign, and submit to its assigned 
Medicare Administrative Contractor (MAC) the appropriate enrollment 
form, typically the Form CMS-855 (OMB Control No. 0938-0685). The Form 
CMS-855, which can be submitted via paper or electronically through the 
internet-based Provider Enrollment, Chain, and Ownership System (PECOS) 
process (System of Records notice (SORN): 09-70-0532, PECOS), collects 
important information about the provider or supplier. Such data 
includes, but is not limited to, general identifying information (for 
example, legal business name), licensure and/or certification data, 
ownership information, and practice locations. The application is used 
for a variety of provider enrollment transactions, including the 
following:
     Initial enrollment--The provider or supplier is--(1) 
enrolling in Medicare for the first time; (2) enrolling in another 
Medicare contractor's jurisdiction; or (3) seeking to enroll in 
Medicare after having previously been enrolled.
     Change of ownership--The provider or supplier is reporting 
a change in its ownership.
     Revalidation--The provider or supplier is revalidating its 
Medicare enrollment information in accordance with Sec.  424.515. 
(Suppliers of durable medical equipment, prosthetics, orthotics, and 
supplies (DMEPOS) must revalidate their enrollment every 3 years; all 
other providers and suppliers must do so every 5 years.)
     Reactivation--The provider or supplier is seeking to 
reactivate its Medicare enrollment and billing privileges after it was 
deactivated in accordance with Sec.  424.540.
     Change of information--The provider or supplier is 
reporting a change in its existing enrollment information in accordance 
with Sec.  424.516.
    After receiving the provider's or supplier's initial enrollment 
application, CMS or the MAC reviews and confirms the information 
thereon and determines whether the provider or supplier meets all 
applicable Medicare requirements. We believe this screening process has 
greatly assisted CMS in executing its responsibility to prevent 
Medicare fraud, waste, and abuse.
    As previously discussed, over the years we have issued various 
final rules pertaining to provider enrollment. These rules were 
intended not only to clarify or strengthen certain components of the 
enrollment process but also to enable us to take action against 
providers and suppliers: (1) engaging (or potentially engaging) in 
fraudulent or abusive behavior; (2) presenting a risk of harm to 
Medicare beneficiaries or the Medicare Trust Funds; or (3) that are 
otherwise unqualified to furnish Medicare services or items. Consistent 
with this, and as we discuss in section VII.B. of this final rule, we 
proposed a change to our existing Medicare provider enrollment 
regulations.
2. Legal Authorities
    There are two principal categories of legal authorities for the 
Medicare provider enrollment provision addressed in section VII.B. of 
this final rule:
     Section 1866(j) of the Act furnishes specific authority 
regarding the enrollment process for providers and suppliers.
     Sections 1102 and 1871 of the Act provide general 
authority for the Secretary to prescribe regulations for the efficient 
administration of the Medicare program.

B. Provisional Period of Enhanced Oversight (PPEO)

1. Background
    Section 1866(j)(3)(A) of the Act states that the Secretary shall 
establish procedures to provide for a provisional period of between 30 
days and 1 year during which new providers and suppliers--as the 
Secretary determines appropriate, including categories of providers or 
suppliers--will be subject to enhanced oversight. (Per section 
1866(j)(3)(A) of the Act, such oversight can include, but is not 
limited to, prepayment review and payment caps.) CMS' authority under 
section 1866(j)(3)(A) of the Act to impose a PPEO is not restricted to 
certain provider and supplier types (for example, hospices) but can 
apply to any provider or supplier type the Secretary determines 
appropriate.
    As authorized by section 1866(j)(3)(B) of the Act, we previously 
implemented such procedures through subregulatory guidance with respect 
to newly enrolling HHAs' requests for anticipated payments (RAP).\139\ 
More recently, in July 2023 we began placing new hospices located in 
Arizona, California, Nevada, and Texas in a provisional period of 
enhanced oversight. (See https://www.cms.gov/files/document/mln7867599-period-enhanced-oversight-new-hospices-arizona-california-nevada-texas.pdf for more information.)
---------------------------------------------------------------------------

    \139\ CMS eliminated the use of RAPs for HHAs; beginning January 
1, 2022, CMS replaced RAP submissions with a Notice of Admission.
---------------------------------------------------------------------------

    During the PPEO involving HHA RAPs, CMS received several 
stakeholder requests for clarification regarding the PPEO's scope. One 
of these concerned the meaning of the term ``new'' for purposes of 
applying a PPEO. While section 1866(j)(3)(B) of the Act states that we 
may implement procedures by program instruction, we finalized new Sec.  
424.527(a) in the CY 2024 HH PPS final rule to address this issue. 
Specifically, new Sec.  424.527(a)(1) through (3) defined a ``new'' 
provider or supplier (again, exclusively for purposes of our PPEO 
authority under section 1866(j)(3) of the Act) as any of the following:
     A newly enrolling Medicare provider or supplier. (This 
includes providers that must enroll as a new provider per the change in 
majority ownership provisions in Sec.  424.550(b).)
     A certified provider or certified supplier undergoing a 
change of ownership consistent with the principles of 42 CFR 489.18. 
(This includes providers that qualify under Sec.  424.550(b)(2) for an 
exception from the change in majority ownership requirements in Sec.  
424.550(b)(1) but which are undergoing a change of ownership under 42 
CFR 489.18.)
     A provider or supplier (including an HHA or hospice) 
undergoing a 100 percent change of ownership via a change of 
information request under Sec.  424.516.

[[Page 88467]]

    We included these transactions within this definition because they 
have historically involved the effective establishment of a new 
provider or supplier for purposes of Medicare enrollment. For this 
reason, we have also received recent inquiries as to whether a 
reactivation should fall within the scope of Sec.  424.527(a).
    Under Sec.  424.540 and the definition of ``deactivate'' in Sec.  
424.502, a deactivated provider's or supplier's enrollment and billing 
privileges are ``stopped but can be restored upon the submission of 
updated information.'' This restoration, or reactivation, generally 
involves: (1) the completion of a full Form CMS-855 application; and 
(2) a CMS or MAC determination as to whether the provider or supplier 
meets all enrollment requirements. These two steps generally mirror 
what occurs with the initial and change of ownership applications 
referenced in Sec.  424.527(a). Although a deactivation does not rise 
to the level of a revocation of Medicare enrollment and billing 
privileges under Sec.  424.535--for a revocation bars the provider or 
supplier from reenrolling in Medicare for a period of 1 to 10 years 
(with certain exceptions)--a deactivated provider or supplier cannot 
resume billing Medicare until the requirements for reactivation are 
met. It has, in effect, been blocked from the Medicare program. Indeed, 
as with a provider or supplier that voluntarily terminated its Medicare 
enrollment and now seeks to rejoin the program via an initial, new 
enrollment application, a reactivating provider, too, is requesting to 
rejoin the program. Described otherwise, a reactivating provider or 
supplier is resuming its involvement in the Medicare program after a 
stoppage (which, at least for practical and operational purposes, 
amounts to a loss) of Medicare enrollment and billing privileges. From 
this standpoint, we thus believe that a reactivating provider or 
supplier is no less ``new'' (for provider enrollment purposes) than one 
that is initially enrolling or undergoing a change of ownership.
    For these and other reasons discussed in the proposed rule, we 
proposed to add a new paragraph (a)(4) to Sec.  424.527 that includes 
providers and suppliers that are reactivating their enrollment and 
billing privileges under Sec.  424.540(b). We elected to address this 
issue via rulemaking in Sec.  424.527(a)(4). However, we retain the 
authority under section 1866(j)(3)(B) of the Act to establish and 
implement PPEO procedures via sub-regulatory guidance.
    We received approximately 20 comments on our proposal. Summaries 
thereof and our responses are attached.
    Comment: Several commenters supported our proposed change.
    Response: We appreciate the commenters' support.
    Comment: A commenter stated that 1 year of additional oversight is 
a reasonable timeframe for enhanced oversight but should not extend 
beyond that period unless there is reasonable evidence that non-
compliance is occurring. Another commenter stated that CMS should 
outline in the final rule the methods it uses to determine the length 
of a PPEO.
    Response: While we appreciate these comments, they do not directly 
pertain to the subject of our PPEO proposal, which is the expansion of 
the ``new provider or supplier'' definition to include reactivations. 
They instead involve the broader operational aspects of the overall 
PPEO process. Therefore, we respectfully believe they are outside the 
scope of this final rule.
    Comment: Several commenters stated that CMS must furnish clear 
guidance to providers and suppliers under a PPEO concerning: (1) the 
PPEO's implementation and activities; (2) timelines for review; (3) 
appeals processes; (4) provider education; and (5) CMS' criteria for 
imposing sanctions and penalties.
    Response: We appreciate these comments but respectively believe 
they are outside the scope of this final rule.
    Comment: A commenter urged CMS to target any PPEO towards providers 
and suppliers engaging in egregious conduct rather than those 
furnishing services in good faith.
    Response: We appreciate this comment but respectively believe it is 
outside the scope of this final rule.
    Comment: A commenter recommended that PPEOs use pre-claim review 
for specific claim edits or targeted probe and educate audits to ensure 
that conditions of payment are met.
    Response: We appreciate this comment but respectively believe it is 
outside the scope of this final rule.
    Comment: A commenter stated that CMS should go beyond the 
application of PPEOs and take further measures to address program 
integrity issues, especially among home health agencies (HHAs). This 
could include, for example, greater scrutiny of HHA owners, publication 
and auditing of ownership data, and closer monitoring of patient care.
    Response: We appreciate this comment but respectively believe it is 
outside the scope of this final rule.
    Comment: A commenter expressed concern that provider and supplier 
claims can be subject to multiple types of CMS reviews at the same 
time, such as Unified Program Integrity Contractor audits, 
Comprehensive Error Rate Testing reviews, and now PPEOs. The commenter 
believed that performing these reviews concurrently is unnecessary and 
places an undue burden on the affected provider or supplier. The 
commenter suggested that CMS cease these simultaneous reviews and 
instead combine them into a single review or, if this is not possible, 
limit the scope and number of concurrent reviews.
    Response: We appreciate this comment but respectively believe it is 
outside the scope of this final rule.
    Comment: A commenter stated that CMS should consider the 
deactivation reason in determining whether a reactivating provider or 
supplier should be subject to a PPEO. More specifically, the commenter 
recommended limiting PPEO application to reactivating providers and 
suppliers that were deactivated for a verifiable instance of non-
compliance with enrollment requirements.
    Response: We believe the commenter is referencing Sec.  
424.540(a)(4), which permits deactivation based on enrollment non-
compliance. As we explained at length in the proposed rule, there are 
deactivation reasons other than Sec.  424.540(a)(4) that involve 
provider or supplier non-compliance. These include all of the 
following:
     Failing to report a change to the provider's or supplier's 
enrollment information within the required timeframe (Sec.  
424.540(a)(2)).
     Failing to timely respond to a revalidation request (Sec.  
424.540(a)(3)).
     Having a non-operational or otherwise invalid practice 
location (Sec.  424.540(a)(5)).
    Section 424.540(a)(1), meanwhile, permits deactivation if the 
provider or supplier has not billed Medicare for 6 or more consecutive 
months. A reactivation request after many months of billing inactivity 
could raise questions as to whether, for instance: (1) the provider or 
supplier will remain compliant with Medicare enrollment requirements 
once reactivated; or (2) another party has compromised the provider's 
or supplier's deactivated billing privileges and seeks to fraudulently 
bill Medicare via the latter's reactivated enrollment. Indeed, we noted 
in the proposed rule that we have identified these latter scenarios and 
believe that using a PPEO to closely monitor reactivated providers or 
suppliers that had been deactivated under Sec.  424.540(a)(1) would 
help ensure program integrity.

[[Page 88468]]

    The proposed rule also noted the deactivation reasons in Sec.  
424.540(a)(6) through (8). These are, respectively: (1) the provider or 
supplier is deceased; (2) the provider or supplier has voluntarily 
withdrawn from Medicare; and (3) the provider is the seller in an HHA 
ownership change under Sec.  424.550(b). In each of these situations, 
the provider has departed the Medicare program, meaning the provider in 
effect is no longer compliant with Medicare enrollment requirements 
since it is not actively enrolled. If a provider that was deactivated 
under Sec.  424.540(a)(7) or (8) is seeking to reenter the program, 
therefore, we must ensure the provider is not only compliant with 
Medicare enrollment requirements but also remains such during the 
period following its enrollment--hence the importance of the PPEO. A 
requested reactivation of a provider that was deactivated under Sec.  
424.540(a)(6) raises particularly serious concerns, for the requesting 
party might be attempting to use the deceased provider's identity to 
enter and fraudulently bill Medicare.
    In sum, we believe that each reactivation scenario, regardless of 
the underlying deactivation reason, requires thorough scrutiny of the 
reactivating provider via the PPEO.
    Comment: A commenter stated that providers and suppliers that do 
not appear to be reactivating for inappropriate purposes (for example, 
fraud) should be exempt from a PPEO. The commenter believed this could 
include, for instance, providers and suppliers that had been 
deactivated for 6 consecutive months of Medicare non-billing or for 
failing to respond to a revalidation request.
    Response: We previously explained that when a provider or supplier 
is reactivating its Medicare enrollment, it is, to some degree, 
reentering the Medicare program as would a new provider or supplier or 
one undergoing an ownership change. Given some of the similarities of 
these three transaction types in terms of CMS scrutiny and screening of 
their incoming CMS enrollment applications, we believe it is proper to 
apply a PPEO to all reactivating providers and suppliers irrespective 
of the deactivation reason. Moreover, part of the PPEO's purpose is to 
ensure that the reactivating provider or supplier is not reentering 
Medicare with nefarious objectives. To the extent the commenter is 
suggesting we do so, we cannot automatically assume the provider or 
supplier has no intent to engage in fraud, waste, or abuse based solely 
on the reason for their deactivation. To illustrate, we have noted that 
a provider or supplier reactivating their enrollment after 6 
consecutive months of non-billing may, in fact, be a party that has 
compromised that provider's or supplier's deactivated billing 
privileges. PPEO(s) help us confirm that this is not the case, and that 
the provider or supplier is legitimate and compliant. We thus 
respectfully decline the commenter's recommended exemption.
    Comment: A commenter appeared to suggest that instead of applying a 
PPEO to reactivating providers and suppliers that were deactivated for 
enrollment non-compliance, CMS could instead require the reactivating 
provider or supplier to: (1) undergo CMS Medicare Learning Network 
(MLN)-based training; or (2) participate in a performance improvement 
plan (PIP).
    Response: We respectfully disagree. In our view, neither of the 
commenter's recommended alternatives furnish the level of CMS scrutiny 
that a PPEO provides. For example, they would not involve a detailed 
CMS review of claim accuracy or billing patterns, actions that are 
possible under a PPEO and help ensure that a reactivated provider or 
supplier is not engaging in fraud, waste, or abuse. Indeed, preventing 
such conduct and facilitating program integrity are the central 
purposes of a PPEO, and we do not believe that training and PIPs, 
though useful, can by themselves sufficiently fulfill these aims.
    After considering the comments we received, we are finalizing our 
proposed change to Sec.  424.527(a)(4) without modification.

VIII. Collection of Information Requirements

A. Statutory Requirement for the Solicitation of Comments

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

B. Information Collection Requirements (ICRs)

    In the CY 2025 HH PPS rule, we solicited public comment on each of 
these issues for the following sections of this document that contain 
information collection requirements (ICRs).
1. ICRs for HH QRP
    As discussed in section III.D.3. of this rule, we proposed to 
collect four additional items as standardized patient assessment data 
elements and modified one item collected as a standardized patient 
assessment data element beginning with the CY 2027 HH QRP. The four 
assessment items proposed for collection are (1) Living Situation, (2) 
Food Runs Out, (3) Food Doesn't Last, and (4) Utilities. We also 
propose replacing the current Access to Transportation item with a 
revised Transportation (Access to Transportation) item beginning with 
the CY 2027 HH QRP as outlined in section III.D.5. of this rule. All 
elements discussed will be collected at the start of care timepoint. We 
assumed the Living Situation and Utilities data elements require 0.3 
minutes each of clinician time to complete. We assumed the Food Runs 
Out and Food Doesn't Last data elements require 0.15 minutes each of 
clinician time to complete. We assumed the replacement of the current 
Access to Transportation item with a revised Transportation will not 
result in a change in burden. Therefore, we estimated that there will 
be an increase in clinician burden per OASIS assessment of 0.9 minutes 
at start of care.
    As stated in section III.E. of this rule, CMS also proposed an 
update to the removal of the suspension of OASIS all-payer data 
collection to change all-payer data collection beginning with the start 
of care OASIS data collection timepoint instead of discharge timepoint. 
There is no associated change in burden resulting from this provision 
as burden for collection of for non-Medicare/non-Medicaid patients at 
all OASIS data collection timepoints was estimated in the CY 2023 HH 
PPS final rule.
    The net effect of these provisions is an increase in four data 
elements collected at the start of care for the OASIS implemented on 
January 1, 2027.
    For purposes of calculating the costs associated with the 
information collection requirements, we obtained median hourly wages 
for these from the U.S. Bureau of Labor Statistics' May 2023 National 
Occupational Employment and Wage Estimates

[[Page 88469]]

(https://www.bls.gov/oes/current/oes_nat.htm). To account for other 
indirect costs such as overhead and fringe benefits (100 percent), we 
have doubled the hourly wage. These amounts are detailed in table 28.
[GRAPHIC] [TIFF OMITTED] TR07NO24.058

    The OASIS is completed by RNs or PTs, or very occasionally by 
occupational therapists (OT) or speech language pathologists (SLP/ST). 
Data from 2021 show that the SOC/ROC OASIS is completed by RNs 
(approximately 77.14 percent of the time), PTs (approximately 22.16 
percent of the time), and other therapists, including OTs and SLP/STs 
(approximately 0.7 percent of the time). Based on this analysis, we 
estimated a weighted clinician average hourly wage of $85.73, inclusive 
of fringe benefits, using the hourly wage data in table 28 0.7714 x 
82.76 + 0.2216 x 95.98 + 0.007 x 89.26 = 85.74. Individual providers 
determine the staffing resources necessary.
    For purposes of estimating burden, we compare the item-level burden 
estimates for the OASIS that will be released on January 1, 2027, to 
the OASIS-E1 as anticipated for implementation as of January 1, 2025, 
and finalized in CY2024 HH PPS final rule. The first component needed 
to calculate burden is the total estimated assessments for each year in 
question. Table 29 shows the total number of OASIS assessments that 
HHAs completed in CY 2023 at start of care and resumption of care. It 
also outlines the estimated assessments that are expected to be 
collected in 2025 based on a 30 percent increase in completed 
assessments required for all payer data submission requirements for 
(CY23 assessment total + CY23 assessment total *0.3 = Estimated CY25 
Assessment total based on all payer data collection).
[GRAPHIC] [TIFF OMITTED] TR07NO24.059

    The totals from table 29 are used to calculate the hourly burden 
estimates in table 30 based on the following calculations:
Start of Care
Estimated time spent per each 2025 OASIS-E1 SOC Assessment/Patient = 
56.4 clinician minutes
200 data elements x (range of 0.15 to 0.3) minutes per data element = 
56.4 minutes of clinical time spent to complete data entry for the 
OASIS-E1 SOC assessment
     21 data elements counted as 0.15 minutes/data element 
(3.15 minutes)
     9 data elements counted as 0.25 minutes/data element (2.25 
minutes)
     170 data elements counted as 0.30 minutes/data element (51 
minutes)

Clinician Estimated hourly burden for all HHAs (11,904) for 2025 OASIS-
E1 SOC assessments = 8,099,309 hours
56.4 clinician minutes per SOC assessment x 8,616,286 assessments = 
485,958,530 minutes/60 minutes per hour = 8,099,309 hours for all HHAs

Estimated time spent per each 2027 OASIS SOC Assessment/Patient = 57.3 
clinician minutes
204 data elements x (range of 0.15 to 0.3) minutes per data element = 
57.3 minutes of clinical time spent to complete data entry for the 
OASIS SOC assessment
     23 data elements counted as 0.15 minutes/data element 
(3.45 minutes)
     9 data elements counted as 0.25 minutes/data element (2.25 
minutes)
     172 data elements counted as 0.30 minutes/data element 
(51.6 minutes)
Clinician Estimated hourly burden for all HHAs (11,904) for 2027 OASIS 
SOC assessments = 8,228,553 hours
57.3 clinician minutes per SOC assessment x 8,616,286 assessments = 
493,713,188 minutes/60 minutes per hour = 8,228,553 hours for all HHAs
Resumption of Care
Estimated time spent per each 2025 OASIS-E1 ROC Assessment/Patient = 
47.1 minutes
169 data elements x (range of 0.15 to 0.3) minutes per data element = 
47.1 minutes of clinical time spent to complete data entry for the 
OASIS-E1 ROC assessment
     19 data elements counted as 0.15

[[Page 88470]]

minute/data element (2.85 minutes)
     9 data elements counted as 0.25 minute/data element (2.25 
minutes)
     140 data elements counted as 0.30 minute/data element (42 
minutes)

Clinician Estimated Hourly Burden for all HHAs for 2025 OASIS-E1 ROC 
assessments = 823,310 hours
47.1 clinician minutes per ROC assessment x 1,184,618 ROC assessments 
=55,795,508 minutes/60 minutes = 929,925 hours for all HHAs

Estimated time spent per each 2027 OASIS ROC Assessment/Patient = 48 
minutes
173 data elements x (range of 0.15 to 0.3) minutes per data element = 
48 minutes of clinical time spent to complete data entry for the OASIS 
ROC assessment
     21 data elements counted as 0.15 minute/data element (3.15 
minutes)
     9 data elements counted as 0.25 minute/data element (2.25 
minutes)
     142 data elements counted as 0.30 minute/data element 
(42.6 minutes)
Clinician Estimated Hourly Burden for all HHAs for 2027 OASIS ROC 
assessments = 947,694 hours
48 clinician minutes per ROC assessment x 1,184,618 ROC assessments = 
56,861,664 minutes/60 minutes = 947,694 hours for all HHAs

    Table 30 summarizes the estimated clinician hourly burden for the 
OASIS that will be implemented in 2027 with the proposed rule's changes 
of an increase in four data elements at start of care and resumption of 
care compared to the anticipated 2025 OASIS-E1 burden. This is 
calculated by multiplying the total number of assessments by the 
increase in assessment time required. We calculated the 2025 and 2027 
burden estimate in minutes and then calculated an hourly burden shown 
in table 30. We estimated a net increase of 147,013 hours of clinician 
burden across all HHAs or 12.35 hours (147,013/11,904) for each of the 
11,904 active HHAs.
[GRAPHIC] [TIFF OMITTED] TR07NO24.060

    Table 31 summarizes the estimated clinician costs for the 2025 
OASIS-E1 and the 2027 OASIS with the net addition of four data elements 
at start of care using CY 2023 BLS wage inputs. Total clinician cost 
for 2025 and 2027 is estimated by multiplying total hourly burden for 
each year as reported in table 31 by the weighted clinician average 
hourly wage of $85.74. We then calculated the difference in clinician 
estimated costs between 2027 and 2025. This calculates the estimated 
increase in costs associated with adding the four data elements at 
start of care and resumption of care. We estimated an increase in 
clinician costs $12,604,894.62 between 2027 and 2025 related to the 
implementation of the proposals outlined in this rule across all HHAs 
or a $1,058.88 increase ($12,604,894.62/11,904) for each of the 11,904 
active HHAs. This increase in burden will begin with the January 1, 
2027, OASIS assessments.
[GRAPHIC] [TIFF OMITTED] TR07NO24.061

    Comment: Commenters that supported the proposal expressed concerns 
about implementation including that the vendors be provided enough time 
to prepare for the changes, that home health agencies be provided time 
and resources to educate staff on the changes, that OASIS revisions are 
too frequent and burdensome for agencies and that implementation of the 
proposal would be burdensome. Some commenters cautioned that SDOH needs 
identified must be addressed, and one suggested that CMS should provide 
additional reimbursement to HHAs for the follow-up required to address 
identified needs.
    Response: We acknowledge the commenters' concerns and appreciate 
their suggestions. We proposed the SDOH data elements in the CY 2025 HH 
PPS proposed rule with an effective date to begin collection via the 
OASIS instrument of January 1, 2027, to ensure that vendors and HHAs 
have sufficient time to prepare for implementation. We will make 
training available to HHAs on the changes to the OASIS, consistent with 
education and training resources for previous revisions to the OASIS 
instrument. We acknowledge that revisions to the OASIS require time and 
effort and resources for providers to prepare for the changes and we 
are committed to proposing revisions to the OASIS no more frequently 
than every 2 years. We agree that patients' needs should be addressed 
by the HHA, consistent with applicable rules and regulations, although 
we note that the proposal does not specify a requirement

[[Page 88471]]

for how HHAs may address patients' needs.
    Comment: Commenters that did not support the proposal acknowledged 
that SDOH information is important but adding four data elements to the 
OASIS and modifying a fifth would be burdensome. A commenter noted that 
revisions to the OASIS are too frequent and recommended that CMS limit 
revisions to intervals of no less than 4 years. Another commenter 
suggested that the proposed living situation data element is 
duplicative of information that is already collected and recommended 
that the look-back for the utilities data element be changed from 12 
months to three to capture more reliable, valid, and timely 
information. Another commenter encouraged CMS to consider using SDOH 
information as part of the risk-adjusted outcome quality measures. A 
commenter stated the proposal is not aligned with health-related social 
needs reporting requirements across the care continuum and that further 
testing and refinement are needed to ensure the proposed items work as 
intended in this setting. This commenter noted that CMS' evaluation of 
the AHC HRNS screening tool in the AHC Model showed that screening did 
not appear to increase beneficiary connection to community resources or 
health-related social need resolution, and they recommended CMS conduct 
further testing and developing clearer implementation guidance before 
adopting the proposed data elements in the HHQRP.
    Response: We acknowledge the commenters' concerns and appreciate 
their suggestions. As previously stated, we acknowledge that revisions 
to the OASIS require time and effort and resources for providers to 
prepare for the changes and we are committed to proposing revisions to 
the OASIS no more frequently than every 2 years. We disagree that the 
proposed Living Situation data element is duplicative of information 
that is already collected because it addresses housing insecurity, 
which is not part of the information captured in the current OASIS. We 
believe that the proposed data elements are not setting-specific, and 
that the testing conducted in their development has been sufficiently 
rigorous that we can adopt the data elements into the OASIS and the 
other PAC instruments with confidence.
    After consideration of the public comments received, we are 
finalizing our proposal to adopt four new items as standardized patient 
assessment data elements in the SDOH category: one living situation 
item, two food items, and one utilities item, and to modify the 
transportation item in section III.C.D. of this rule beginning January 
1, 2027, with the CY 2027 HH QRP.
2. ICRs for the Expanded HHVBP Model
    The RFI and the health equity update for the expanded HHVBP Model 
included in section IV. of this rule do not result in an increase in 
costs to HHAs. Section 1115A(d)(3) of the Act exempts Innovation Center 
model tests and expansions, which include the expanded HHVBP Model, 
from the provisions of the PRA. Specifically, this section provides 
that the provisions of the PRA do not apply to the testing and 
evaluation of Innovation Center models or to the expansion of such 
models.
3. ICRs Related to Conditions of Participation (CoPs): Organization and 
Administration of Services (Sec.  484.105)
    In section VI.A. of the rule, we discussed our proposal to add a 
new standard at Sec.  484.105(i), which would set forth a requirement 
for HHAs to establish an ``acceptance-to-service'' policy. This new 
standard would require the HHA to develop, implement, and maintain 
through an annual review a patient acceptance-to-service policy that 
addressed criteria related to the HHA's capacity to provide patient 
care, including, but not limited to, anticipated needs of the referred 
prospective patient, case load and case mix of the HHA, staffing levels 
of the HHA, and competencies and skills of the HHA staff. In addition, 
we proposed the HHA would have to make public accurate information 
about the services offered by the HHA and any limitations related to 
the types of specialty services, service duration, and service 
frequency. We believe that most HHAs already have a policy related to 
the admission to service. The burden associated with this requirement 
is the burden required to develop, implement, and maintain an updated 
policy that would meet the requirements of this rule, and the burden 
associated with making specified information available to the public.
    Section 1861(o)(2) of the Act requires HHAs to have policies 
established by a group of professional personnel (associated with the 
agency or organization), including one or more physicians and one or 
more registered professional nurses. Therefore, we expect the HHA to 
utilize a physician and nurse to create and update the HHA's policies. 
We estimated there are 9,565 Medicare-certified HHAs and that the 
proposed new requirement would take 1 hour each of a physician and a 
registered nurse's time on a one-time basis, for an HHA to develop an 
acceptance-to-service policy at a cost of $321.84 per HHA and 
$3,078,400 for all HHA's. We also estimated the HHA nurse would review 
the acceptance-to-service policy on an annual basis. This annual review 
would take 5 minutes for an HHA nurse at a cost of $7.00 per HHA for 
all HHAs to fulfill this requirement.
    In addition, we estimated that the proposed requirement would take 
15 minutes on a one-time basis for an HHA to the specified information 
public at a cost of $10.43 per HHA or $99,763 for all HHA's, based on 
the assumption that the HHA administrative professional will process 
this task. The average hourly rate for an administrative employee is 
$41.70, therefore it is $10.43 per HHA, or $99,763 for all HHA's to 
fulfill the requirement. We also proposed that the HHA administrative 
professional would review this website annually to assure the continued 
accuracy of the posted information. This annual review would take 5 
minutes at a cost of $3.48 per HHA or $33,286 for all HHA's to fulfill 
this requirement.

[[Page 88472]]

[GRAPHIC] [TIFF OMITTED] TR07NO24.062

    Comment: A few commenters stated that CMS did not adequately 
account for the burden of the proposed acceptance-to-service policy in 
their estimates for compliance that maintaining the proposed policy 
would take HHAs appreciably more than 5 minutes per year and that the 
amount that CMS estimated ($9,000 to implement and $30,000 to maintain) 
would be insurmountable for small agencies. Likewise, a commenter 
stated that the estimate of $99,763 as a one-time cost for making the 
information public equates to approximately $9.07 per HHA which is less 
than the commenter believes this activity will cost. Other commenters 
stated that they did not support the proposed acceptance-to-service 
policy because of concerns that data collection and reporting for such 
a policy will create additional administrative burden for HHAs.
    Response: We appreciate the commenters feedback on burden estimates 
for the development of the proposed acceptance-to-service policy and 
the requirement to make this information public and update annually. We 
agree with the commenters feedback and have made adjustments to the 
burden estimates.
    To develop the acceptance-to-service policy, we expect the HHA to 
utilize a physician and nurse to create and update the HHA's policies. 
We estimated there are 9,565 Medicare-certified HHAs and that the 
proposed new requirement would take 2 hours each of a physician and a 
registered nurse's time on a one-time basis, for an HHA to develop an 
acceptance-to-service policy at a cost of $643.68 per HHA ($82.76 x 2 + 
$239.08 x 2) and $6,156,799 for all HHA's ($1,583,199 + $4,573,600). We 
also estimated the HHA nurse would review the acceptance-to-service 
policy on an annual basis. This annual review would take 30 minutes for 
an HHA nurse at a cost of $41.38 per HHA ($82.76 x 30/60 minutes) and 
$395,799.70 for all HHA's ($41.38 x 9,565) to fulfill this requirement.
    In addition, we estimated that the proposed requirement to make the 
specified information public would take an HHA 30 minutes on a one-time 
basis at a cost of $20.85 per HHA or $199,430.25 for all HHA's, based 
on the assumption that the HHA administrative professional will process 
this task. The average hourly rate for an administrative employee is 
$41.70, therefore it is $20.85 per HHA ($41.70 hour x 30/60 minutes) or 
$199,430.25 for all HHA's ($20.85 x 9,565) to fulfill the requirement. 
We also proposed that the HHA administrative professional would review 
information to ensure accuracy as frequently as the services change. We 
revised the requirement at Sec.  484.105(i)(2) to require HHAs to 
review public information regarding services offered, service 
limitations, or service frequency as frequently as the services as 
changed, but no less often than annually. Therefore, we estimate the 
average HHA may need to update this service information as frequently 
as 4 to 6 times per year, but no less than annually to assure the 
continued accuracy of the posted information. We estimate this review 
will take 10 minutes per review with an estimated six reviews annually 
at a cost of $41.70 for an HHA ($41.70 x 10/60 minute = $6.95 x 6 = 
$41.70) or $398,860.50 for all HHA's (41.70 x 9,565 = $398,860.50) to 
fulfill this requirement.
[GRAPHIC] [TIFF OMITTED] TR07NO24.063


[[Page 88473]]


    After consideration of the public comments we received, we are 
modifying the final burden estimated for home health agencies to be in 
compliance with the acceptance-to-service policy.
4. ICRs for Provider Enrollment Provisions
    Section 1866(j)(3)(A) of the Act states that the Secretary shall 
establish procedures to provide for a provisional period of between 30 
days and 1 year during which new providers and suppliers--as the 
Secretary determines appropriate, including categories of providers or 
suppliers--will be subject to enhanced oversight. Some of these 
procedures have been codified in Sec.  424.527. As explained in section 
VII. of this rule, we proposed to expand the definition of ``new 
provider or supplier'' in Sec.  424.527(a) (solely for purposes of 
applying a provisional period of enhanced oversight) to include 
providers and suppliers that are reactivating their Medicare enrollment 
and billing privileges under Sec.  424.540(b). We stated in the 
proposed rule that we do not anticipate any ICR burden associated with 
this provision, for we are merely expanding an existing regulatory 
definition.
    We did not receive any comments on our ICR estimates and are 
therefore finalizing them as proposed.
5. ICRs Related to LTC Requirements for Acute Respiratory Illness 
Reporting Sec.  483.80(g)
    In section VII.B. of this rule we discussed the final policy 
related to LTC requirements for acute respiratory illness reporting. At 
Sec.  483.80(g)(1)(i) through (ix) and (g)(2), we proposed to replace 
the existing reporting requirements for LTC facilities with new 
requirements to report information addressing respiratory illnesses. 
Beginning on January 1, 2025, facilities would be required to 
electronically report information about COVID-19, influenza, and RSV in 
a standardized format and frequency specified by the Secretary. To the 
extent to be determined by the Secretary, through this rulemaking 
cycle, we proposed that the data elements for required reporting would 
include--
     Facility census;
     Resident vaccination status for a limited set of 
respiratory illnesses including but not limited to COVID-19, influenza, 
and RSV;
     Confirmed, resident cases of a limited set of respiratory 
illnesses including but not limited to COVID-19, influenza, and RSV 
(overall and by vaccination status); and
     Hospitalized residents with confirmed cases of a limited 
set of respiratory illnesses including but not limited to COVID-19, 
influenza, and RSV (overall and by vaccination status.).
    In the absence of a declared national PHE for an acute respiratory 
illness, we proposed that LTC facilities would continue to report these 
data on a weekly basis through a format specified by the Secretary and 
specifically noted that we intend to continue reporting through the 
CDC's NHSN. We indicated that there may be instances in which the 
Secretary may determine a need to change reporting frequency, such as 
during a future PHE, and we would provide appropriate notice and 
guidance at that time.
    In addition, during a declared national, State, or local PHE for an 
acute infectious illness we also proposed that the Secretary may 
require facilities to report:
     Data up to a daily frequency without additional notice and 
comment rulemaking.
     Additional or modified data elements relevant to the PHE, 
including relevant confirmed infections among staff, supply inventory 
shortages, staffing shortages, and relevant medical countermeasures and 
therapeutics inventories, usage, or both.
    We noted that since the infection prevention and control program 
(IPCP) is the responsibility of the infection preventionist (IP), we 
anticipate that the IP would be responsible for reviewing and updating 
the policies and procedures for the facility's IPCP to comply with 
these proposals. We estimated that it would require 2 hours of the IP's 
time to update the facility's policies and procedures to ensure that 
they reflect the proposed requirements. In analyzing the ICRs related 
to the proposal we obtained salary information from the May 2023 
National Occupational Employment and Wage Estimates, BLS at https://www.bls.gov/oes/current/oes_nat.htm. We calculated the estimated hourly 
rate for an IP using the occupation code for a registered nurse (29-
1141) based on the national mean salary increased by 100 percent to 
account for overhead costs and fringe benefits ($45.42 x 2 = $90.84 
(rounded to $91). According to CMS, there are currently 14,926 LTC 
facilities as of April 2024.\140\
---------------------------------------------------------------------------

    \140\ https://qcor.cms.gov/active_nh.jsp?which=0&report=active_nh.jsp, report ran 4/24/2024.
---------------------------------------------------------------------------

    Based on this salary information and facility data, we estimated 
that total annual burden hours for all LTC facilities to review and 
update their current policies and procedures would be 29,852 hours (2 
hours x 14,926 facilities) at a cost of $2,716,532 (29,852 x $91) or 
$182 ($91 x 2 hours) per facility annually.
    In addition, LTC facilities will need to continue locating the 
required information and electronically reporting in the frequency 
specified to the NHSN. Currently, the ICR associated with this 
reporting requirement under OMB control #0938-1363 (Reform of 
Requirements for Long-Term Care Facilities (CMS-10573)) estimates a 
total burden cost of $55,972,800 (1 hour x 52 weeks x $69 (IP 2022 
salary) x 15,600 LTC facilities as of 2022) based on weekly reporting. 
We expect that ongoing reporting will require continuous efforts to 
collect and organize the information necessary to report the data 
through the NHSN or other system as determined by the Secretary. While 
the number of required data elements for ongoing reporting have 
decreased from the current post-COVID-19 PHE reporting requirements set 
to expire December 2024, we acknowledged that the data elements and 
reporting frequency could increase or decrease due to what the 
Secretary deems necessary based on changes in circumstance or given 
another PHE and these changes would impact this burden estimate. For 
instance, weekly data reporting could be decreased to bi-weekly 
reporting or the increased reporting of additional data elements during 
a PHE could be activated and remain active for less than or more than a 
year depending on the circumstances. Since we cannot predict with 
certainty how often the Secretary would require data reporting for a 
future PHE, we included two burden estimates to cover a range in the 
frequency of reporting. The lower range is based on weekly reporting 
and the higher range is based on daily reporting.
    Based on the assumption of a weekly reporting frequency and 1 hour 
of the IP's time to locate and electronically report the information, 
we estimated that total annual burden hours for all LTC facilities to 
comply would be 776,152 hours (1 hour x 52 weeks x 14,926 facilities) 
at a cost of $70,629,832 (776,152 total hours x $91) or $4,732 ($91 x 1 
hour x 52 weeks) per facility annually.
    Based on the assumption of a daily reporting frequency, we 
estimated that total annual burden hours for all LTC facilities to 
comply would be 5,447,990 hours (1 hour x 365 days a year x 14,926 
facilities) at a cost of $495,767,090 (5,447,990 total hours x $91) or 
$33,215 ($91 x 1 hour x 365 days a year) per facility annually.

[[Page 88474]]

    In summary, we estimated a total annual burden for all LTC 
facilities for the proposed ICRs of 806,004 to 5,477,842 hours at an 
estimated cost of $73,346,364 to $498,483,622 or 54 to 367 hours at an 
estimated cost of $4,914 to $33,397 per facility annually. The ICR 
burden currently associated with Sec.  483.80(g) is included under OMB 
control number 0938-1363; expiration date: April 30, 2026. We will 
submit the revised information collection request to include these 
preliminary estimates to OMB for approval under OMB control number 
0938-1363 (CMS-10914). We note that any additional ICR burden related 
to the specific instruments used for reporting and the time necessary 
to submit/report the data is the National Healthcare Safety Network 
(NHSN) Surveillance in Healthcare Facilities (OMB control number 0920-
1317) package.
[GRAPHIC] [TIFF OMITTED] TR07NO24.064

    We welcomed public comments on our ICR burden estimates, and on 
ways that reporting burden can be minimized while still providing 
adequate data. We also welcomed feedback on any challenges of 
collecting and reporting these data; ways that CMS could reduce 
reporting burden for facilities; and alternative reporting mechanisms 
or quality reporting programs through which CMS could instead 
effectively and sustainably incentivize reporting. Lastly, we welcomed 
comments that address system readiness and capacity to collect and 
report these data.
    Comment: A commenter did not agree with the assumptions used for 
estimating the burden of the proposed LTC respiratory illness data 
reporting requirements. This commenter stated that CMS has 
underestimated the required time for reporting these data and 
underestimated the cost by assuming that the activity would be 
completed by an RN. The commenter stated that this data collection is 
often done by the IP, the Director of Nursing, or the Nursing Home 
Administrator, all of whom have higher wage rates than an RN. The 
commenter noted that the BLS May 2023 National Industry-Specific 
Occupational Employment and Wage Estimates website, estimates the 
median hourly wage for a Nursing Home Administrator at $58.82, which 
raises the cost estimates by almost 50 percent as compared to the 
hourly wage used by CMS. The commenter also notes that the burden 
estimates do not account for other staff that may be involved in 
supporting the IP, the DON, or the Administrator in the data 
collection. Furthermore, they note that the time to gather and report 
the data to NHSN is impacted by facility size, number of weekly 
admissions and discharges, and the outbreak status of the facility. As 
an example, the commenter shares that a facility with an average census 
of 57 residents requires 3 hours per week to report to NHSN and a 
facility with an average census of 76 residents requires 5 hours per 
week to report to NHSN. They note that these estimates are based on the 
time currently necessary to comply with the existing COVID-19 data 
reporting requirements and asserts that the proposed revisions would 
increase this time based on the expanded data reporting elements. This 
commenter recommended that CMS not finalize the proposed rule.
    Response: We appreciate the feedback shared by this commenter 
regarding the effort and time currently exercised by varying facilities 
to comply with the existing COVID-19 data reporting requirements. We 
disagree with the commenter's assertion that the proposed revisions 
would increase burden and believe that the streamlined data elements 
proposed will positively impact data collection and reporting efforts, 
despite the possibility for changes in the frequency of reporting. The 
proposal reduced the number of data elements required for ongoing 
reporting from the current post-COVID-19 PHE reporting requirements set 
to expire December 2024. Specifically, starting on September 30, 2024, 
NHSN will have a single reporting form for all nursing home respiratory 
illness and vaccination data reporting, combining four forms into one, 
and resulting in a significant reporting burden reduction. Several data 
elements were removed, so even with the addition of influenza and RSV 
reporting, this single reporting form and new requirements result in a 
reduction in the number of data fields by 34 (from 50), and an overall 
time and burden reduction. In summary, the changes from the current 
post-PHE COVID-19 reporting to the proposals finalized in this rule 
include removing--
     Staff Pathway (including positive tests among staff)
     Staff COVID-19 vaccination (-20 required fields)
     Total resident deaths
     Resident COVID-19 deaths
     Total beds
     Resident census
     Resident medical contraindications, declinations, and 
other/unknown vaccination statuses. Under the current forms there are 
50 total fields (33 vaccination, 17 Pathways) and under the proposed 
CoP and revised forms there are 16 total fields (includes the addition 
of influenza and RSV).
    In the proposed rule, we provided an explanation of the salary data 
used to inform our estimates. These requirements are a part of a 
facility's responsibility to develop and maintain an infection control 
program and as such, we based on our estimate on the assumption that 
the main individual conducting these activities would be the IP. 
Furthermore, to support the estimate we used the national mean salary 
data for an RN and increased the salary by 100 percent to account for 
overhead costs and fringe benefits. We acknowledge the commenter's 
feedback noting that varying staff types, besides the IP, may be 
responsible for completing the activities necessary to comply with the 
respiratory illness data reporting requirements. However, as the 
commenter noted, the IP is likely one of the individuals that may 
conduct the activities and therefore since we cannot know how often a 
DON or the administrator may be involved, we

[[Page 88475]]

believe our assumption to estimate costs based on the IP, who is a RN, 
is reasonable. We also note that additional burden related to the 
specific instruments used for reporting and the time necessary to 
submit/report the data to the NHSN is account for in the NHSN 
Surveillance in Healthcare Facilities (OMB control number 0920-1317) 
package. This package accounts for additional burden related to the IP 
completing the data entry either manually (25 minutes) or by uploading 
a CSV file (20 minutes) in NHSN. Together, we believe that the burden 
associated for complying with the respiratory illness data reporting 
requirements has been reasonability estimated.

C. Submission of PRA-Related Comments

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

IX. Regulatory Impact Analysis

A. Statement of Need

1. HH PPS
    Section 1895(b)(1) of the Act requires the Secretary to establish a 
HH PPS for all costs of home health services paid under Medicare. In 
addition, section 1895(b) of the Act requires: (1) the computation of a 
standard prospective payment amount include all costs for home health 
services covered and paid for on a reasonable cost basis and that such 
amounts be initially based on the most recent audited cost report data 
available to the Secretary; (2) the prospective payment amount under 
the HH PPS to be an appropriate unit of service based on the number, 
type, and duration of visits provided within that unit; and (3) the 
standardized prospective payment amount be adjusted to account for the 
effects of case-mix and wage levels among HHAs. Section 1895(b)(3)(B) 
of the Act addresses the annual update to the standard prospective 
payment amounts by the home health applicable percentage increase. 
Section 1895(b)(4) of the Act governs the payment computation. Sections 
1895(b)(4)(A)(i) and (b)(4)(A)(ii) of the Act requires the standard 
prospective payment amount be adjusted for case-mix and geographic 
differences in wage levels. Section 1895(b)(4)(B) of the Act requires 
the establishment of appropriate case-mix adjustment factors for 
significant variation in costs among different units of services. 
Lastly, section 1895(b)(4)(C) of the Act requires the establishment of 
wage adjustment factors that reflect the relative level of wages, and 
wage-related costs applicable to home health services furnished in a 
geographic area compared to the applicable national average level.
    Section 1895(b)(3)(B)(iv) of the Act provides the Secretary with 
the authority to implement adjustments to the standard prospective 
payment amount (or amounts) for subsequent years to eliminate the 
effect of changes in aggregate payments during a previous year or years 
that were the result of changes in the coding or classification of 
different units of services that do not reflect real changes in case-
mix. Section 1895(b)(5) of the Act provides the Secretary with the 
option to make changes to the payment amount otherwise paid in the case 
of outliers because of unusual variations in the type or amount of 
medically necessary care. Section 1895(b)(3)(B)(v) of the Act requires 
HHAs to submit data for purposes of measuring health care quality and 
links the quality data submission to the annual applicable percentage 
increase.
    Sections 1895(b)(2) and 1895(b)(3)(A) of the Act, as amended by 
sections 51001(a)(1) and 51001(a)(2) of the BBA of 2018 respectively, 
required the Secretary to implement a 30-day unit of service, for 30-
day periods beginning on and after January 1, 2020. Section 
1895(b)(3)(D)(i) of the Act, as added by section 51001(a)(2)(B) of the 
BBA of 2018, requires the Secretary to annually determine the impact of 
differences between assumed behavior changes, as described in section 
1895(b)(3)(A)(iv) of the Act, and actual behavior changes on estimated 
aggregate expenditures under the HH PPS with respect to years beginning 
with 2020 and ending with 2026. Section 1895(b)(3)(D)(ii) of the Act 
requires the Secretary, at a time and in a manner determined 
appropriate, through notice and comment rulemaking, to provide for one 
or more permanent increases or decreases to the standard prospective 
payment amount (or amounts) for applicable years, on a prospective 
basis, to offset for such increases or decreases in estimated aggregate 
expenditures, as determined under section 1895(b)(3)(D)(i) of the Act. 
Additionally, 1895(b)(3)(D)(iii) of the Act requires the Secretary, at 
a time and in a manner determined appropriate, through notice and 
comment rulemaking, to provide for one or more temporary increases or 
decreases to the payment amount for a unit of home health services for 
applicable years, on a prospective basis, to offset for such increases 
or decreases in estimated aggregate expenditures, as determined under 
section 1895(b)(3)(D)(i) of the Act. The HH PPS wage index utilizes the 
wage adjustment factors used by the Secretary for purposes of sections 
1895(b)(4)(A)(ii) and (b)(4)(C) of the Act for hospital wage 
adjustments.
2. HH QRP
    Section 1895(b)(3)(B)(v) of the Act authorizes the HH QRP, which 
requires HHAs to submit data in accordance with the requirements 
specified by CMS. Failure to submit data required under section 
1895(b)(3)(B)(v) of the Act with respect to a program year will result 
in the reduction of the annual home health market basket percentage 
increase otherwise applicable to an HHA for the corresponding calendar 
year by 2 percentage points.
3. Expanded HHVBP Model
    In the CY 2022 HH PPS final rule (86 FR 62292 through 62336) and 
codified at 42 CFR part 484, subpart F, we finalized our policy to 
expand the HHVBP Model to all Medicare certified HHAs in the 50 States, 
territories, and District of Columbia beginning January 1, 2022. CY 
2022 was a pre-implementation year. CY 2023 was the first performance 
year in which HHAs individual performance on the applicable measures 
will affect their Medicare payments in CY 2025. In this final rule, we 
summarized comments that we received on a RFI related to the future 
measure concepts for the expanded HHVBP Model. The proposed rule also 
included an update on potential future approaches for integrating 
health equity that are being considered for the expanded HHVBP Model. 
This final rule does not make any changes to the expanded HHVBP Model.
4. Home IVIG Items and Services
    Division FF, section 4134 of the CAA, 2023 (Pub. L. 117-328), which 
amended section 1842(o) of the Act, mandated that CMS establish a 
permanent, bundled payment for items and services related to 
administration of IVIG in a patient's home. The permanent, bundled home 
IVIG items and services payment is effective for home IVIG

[[Page 88476]]

infusions furnished on or after January 1, 2024. Payment for these 
items and services is required to be a separate bundled payment made to 
a supplier for all items and services furnished in the home during a 
calendar day. This payment amount may be based on the amount 
established under the Demonstration. The standard Part B coinsurance 
and the Part B deductible apply. The separate bundled payment does not 
apply for individuals receiving services under the Medicare home health 
benefit. Section 1834(j)(5) of the Act clarifies that a supplier who 
furnishes these services meet the requirements of a supplier of medical 
equipment and supplies. The permanent, bundled home IVIG items and 
services payment is updated by the home health update percentage 
beginning January 1, 2025.
5. HHA CoP Changes: Establishing an Acceptance-to-Service Policy
    In sections 1861(o) and 1891 of the Act, the Secretary has 
established in regulations the requirements that an HHA must meet to 
participate in the Medicare program. These requirements are set forth 
in regulations at 42 CFR part 484, Home Health Services, and 
regulations at 42 CFR 440.70(d) specify that HHAs participating in the 
Medicaid program must also meet the Medicare Conditions of 
Participation (CoPs). Section 1861(o)(6) of the Act requires that an 
HHA must meet the CoPs specified in section 1891(a) of the Act, and 
other CoPs as the Secretary finds necessary in the interest of the 
health and safety of patients. The CoPs for HHAs protect all 
individuals under the HHA's care, unless a requirement states that this 
is specifically limited to Medicare beneficiaries. As explained in 
section VI.A. of this rule, we are proposed to add a new standard at 
Sec.  484.105(i) that would require HHAs to develop, consistently 
apply, and maintain an acceptance-to-service policy, including 
specified factors, that would govern the process for accepting patients 
to service. We also proposed that HHAs would be required to make 
specified information about their services and service limitations 
available to the public.
    We received no comments on regulatory impact analysis for the 
proposal and believe there are no additional costs beyond what we have 
recognized in the collection of information section.
6. Provider Enrollment Provisions
    Section 1866(j)(3)(A) of the Act states that the Secretary shall 
establish procedures to provide for a provisional period of between 30 
days and 1 year during which new providers and suppliers--as the 
Secretary determines appropriate, including categories of providers or 
suppliers--will be subject to enhanced oversight. Some of these 
procedures have been codified in 42 CFR 424.527. As explained in 
section VII. of this rule, we proposed to expand the definition of 
``new provider or supplier'' in Sec.  424.527(a) (solely for purposes 
of applying a provisional period of enhanced oversight (PPEO)) to 
include providers and suppliers that are reactivating their Medicare 
enrollment and billing privileges under Sec.  424.540(b).
7. LTC Requirements for Acute Respiratory Illness Reporting
    Sections 1819(d)(3) and 1919(d)(3) of the Act explicitly require 
that LTC facilities develop and maintain an infection control program 
that is designed, constructed, equipped, and maintained in a manner to 
protect the health and safety of residents, personnel, and the general 
public. In addition, sections 1819(d)(4)(B) and 1919(d)(4)(B) of the 
Act explicitly authorize the Secretary to issue any regulations he 
deems necessary to protect the health and safety of residents. As such, 
we are proposed streamlined weekly data reporting requirements for 
certain respiratory illnesses. We are also proposed additional, related 
data elements that could be activated in the event of a future acute 
respiratory illness PHE.
    We did not receive any comments specifically related to the 
regulatory impact analysis for these proposed requirements. Comments 
received on these proposals, including those related to our ICR burden 
estimates and general burden concerns, can be found earlier in the rule 
in the Collection of Information section.

B. Overall Impact

    We have examined the impacts of this final rule as required by 
Executive Order 12866 on Regulatory Planning and Review (September 30, 
1993), Executive Order 13563 on Improving Regulation and Regulatory 
Review (January 18, 2011), Executive Order 14094 on Modernizing 
Regulatory Review (April 6, 2023), the Regulatory Flexibility Act (RFA) 
(September 19, 1980, Pub. L. 96 354), section 1102(b) of the Act, 
section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 
1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 
1999), and the Congressional Review Act (5 U.S.C. 804(2)).
    Executive Orders 12866 and 13563 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). Executive 
Order 14094 amends section 3(f) of Executive Order 12866 to define a 
``significant regulatory action'' as an action that is likely to result 
in a rule: (1) having an annual effect on the economy of $200 million 
or more in any 1 year, or adversely affect in a material way the 
economy, productivity, competition, jobs, the environment, public 
health or safety, or State, local, or Tribal governments or 
communities; (2) creating a serious inconsistency or otherwise 
interfering with an action taken or planned by another agency; (3) 
materially altering the budgetary impacts of entitlement grants, user 
fees, or loan programs or the rights and obligations of recipients 
thereof; or (4) raising legal or policy issues for which centralized 
review would meaningfully further the President's priorities.
    A regulatory impact analysis (RIA) must be prepared for a 
regulatory action that is significant under section 3(f)(1) of E.O. 
12866. Based on our estimates, OMB'S Office of Information and 
Regulatory Affairs (OIRA) has determined this rulemaking is significant 
under section 3(f)(1) of E.O. 12866. Accordingly, we have prepared a 
regulatory impact analysis that presents the costs and benefits of the 
rulemaking to the best of our ability. Pursuant to Subtitle E of the 
Small Business Regulatory Enforcement Fairness Act of 1996 (also known 
as the Congressional Review Act), OIRA has determined that this rule 
meets the criteria set forth in 5U.S.C.804(2). Therefore, OMB has 
reviewed this final rule and the Department has provided the following 
assessment of their impact.

C. Detailed Economic Analysis

1. Effects of the Final Policy Changes for the CY 2025 HH PPS
    This rule updates Medicare payments under the HH PPS for CY 2025. 
The net transfer impact related to the changes in payments under the HH 
PPS for CY 2025 is estimated to be $85 million (0.5 percent). The $85 
million increase in estimated payments for CY 2025 reflects the effects 
of the final CY 2025 home health payment update percentage of 2.7 
percent ($460 million increase), an estimated 1.8 percent decrease that 
reflects the effects of the permanent adjustment ($305 million 
decrease), and

[[Page 88477]]

an estimated 0.4 percent decrease that reflects the effects of an 
updated FDL ($70 million decrease).
    We use the latest data and analysis available. However, we do not 
adjust for future changes in such variables as number of visits or 
case-mix. This analysis incorporates the latest estimates of growth in 
service use and payments under the Medicare home health benefit, based 
primarily on Medicare claims data for periods that ended on or before 
December 31, 2023. We note that certain events may combine to limit the 
scope or accuracy of our impact analysis, because such an analysis is 
future-oriented and, thus, susceptible to errors resulting from other 
changes in the impact time period assessed. Some examples of such 
possible events are newly-legislated general Medicare program funding 
changes made by the Congress or changes specifically related to HHAs. 
In addition, changes to the Medicare program may continue to be made as 
a result of new statutory provisions. Although these changes may not be 
specific to the HH PPS, the nature of the Medicare program is such that 
the changes may interact, and the complexity of the interaction of 
these changes could make it difficult to predict accurately the full 
scope of the impact upon HHAs.
    Table 35 represents how HHA revenues are likely to be affected by 
the final policy changes for CY 2025. For this analysis, we used an 
analytic file with linked CY 2023 OASIS assessments and home health 
claims data for dates of service that ended on or before December 31, 
2023. The first column of table 35 classifies HHAs according to a 
number of characteristics including provider type, geographic region, 
and urban and rural locations. The second column shows the number of 
facilities in the impact analysis. The third column shows the payment 
effects of the permanent assumption adjustment on all payments. The 
aggregate impact of the permanent adjustment reflected in the third 
column does not equal the final -1.975 percent permanent adjustment 
because the adjustment only applies to the national, standardized 30-
day period payments and does not impact payments for 30-day periods 
which are LUPAs. The fourth column shows the payment effects of the 
recalibration of the case-mix weights offset by the case-mix weights 
budget neutrality factor. The fifth column shows the payment effects of 
updating the CY 2025 wage index (that is, the FY 2025 hospital pre-
floor, pre-reclassified wage index for hospital cost reporting periods 
beginning on or after October 1, 2020, and before October 1, 2021 (FY 
2021 cost report data)) with the revised OMB delineations and a 5-
percent cap on wage index decreases. The aggregate impact of the 
changes in the fifth column is zero percent, due to the wage index 
budget neutrality factor. The sixth column shows the payment impacts of 
the final update to the LUPA add-on factors. The seventh column shows 
the payment effects of the final CY 2025 home health payment update 
percentage. The eighth column shows the payment effects of the revised 
FDL, and the last column shows the combined effects of all the final 
provisions.
    Overall, it is projected that aggregate payments in CY 2025 would 
increase by 0.5 percent which reflects the 1.8 percent decrease from 
the permanent adjustment, the 2.7 payment update percentage increase, 
and the 0.4 percent decrease from increasing the FDL. As illustrated in 
table 35, the combined effects of all changes vary by specific types of 
providers and by location. We note that some individual HHAs within the 
same group may experience different impacts on payments than others due 
to the distributional impact of the CY 2025 wage index, the percentage 
of total HH PPS payments that were subject to the LUPA or paid as 
outlier payments, and the degree of Medicare utilization.
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2. Effects of the Changes for the HH QRP for CY 2027
    Failure to submit HH QRP data required under section 
1895(b)(3)(B)(v) of the Act with respect to a program year will result 
in the reduction of the annual home health market basket percentage 
increase otherwise applicable to an HHA for the corresponding calendar 
year by 2 percentage points. For the CY 2023 program year, 820 of the 
11,549 active Medicare-certified HHAs, or approximately 7.1 percent, 
did not receive the full annual percentage increase because they did 
not meet assessment submission requirements. The 820 HHAs that did not 
satisfy the reporting requirements of the HH QRP for the CY 2023 
program year represent $149 million in home health claims payment 
dollars during the reporting period out of a total $16.4 billion for 
all HHAs.
    We proposed to collect four additional items as standardized 
patient assessment data elements and modify one item collected as a 
standardized patient assessment data element beginning with the CY 2027 
HH QRP. The four assessment items proposed for collection were (1) 
Living Situation;(2) Food Runs Out; (3) Food Doesn't Last; and (4) 
Utilities. We also proposed to modify the current Access to 
Transportation item with a revised Transportation (Access to 
Transportation) item beginning with the CY 2027 HH QRP. CMS also 
proposed an update to the removal of the suspension of OASIS all-payer 
data collection to change all-payer data collection beginning with the 
start of care OASIS data collection timepoint instead of discharge 
timepoint. The net effect of these proposals was an increase of four 
data elements at the start of care time point and a net increase in 
burden.
    Section VIII.B.1. of this rule provides a detailed description of 
the net increase in burden associated with the proposed changes. We 
proposed that additions of data elements associated with the HH QRP 
proposals would begin with January 1, 2027, discharges. The cost impact 
of these proposed changes was estimated to be a net increase of 
$12,604,89 5 in annualized cost to HHAs, discounted at 2 percent 
relative to year 2023, over a perpetual time horizon beginning in CY 
2027. We described the estimated burden and cost reductions for these 
measures in section VIII. of this rule. In summary, the implementation 
of proposed provisions outlined in this rule for the HH QRP is 
estimated to increase the burden on HHAs by $1,059 per HHA annually, or 
$12,604,895 for all HHAs annually.
    Commenters that supported the proposal expressed concerns about 
implementation including that the vendors be provided enough time to 
prepare for the changes, that home health agencies be provided time and 
resources to educate staff on the changes, that OASIS revisions are too 
frequent and burdensome for agencies and that implementation of the 
proposal would be burdensome. Some commenters cautioned that SDOH needs 
identified must be addressed, and one suggested that CMS should provide 
additional reimbursement to HHAs for the follow-up required to address 
identified needs.
    Response: We acknowledge the commenters' concerns and appreciate 
their suggestions. We proposed the SDOH data elements in the CY 2025 HH 
PPS proposed rule with an effective date to begin collection via the 
OASIS instrument of January 1, 2027, to ensure that vendors and HHAs 
have sufficient time to prepare for implementation. We will make 
training available to HHAs on the changes to the OASIS, consistent with 
education and training resources for previous revisions to the OASIS 
instrument. We acknowledge that revisions to the OASIS require time and 
effort and resources for providers to prepare for the changes and is 
committed to proposing revisions to the OASIS no more frequently than 
every 2 years. We agree that patients' needs should be addressed by the 
HHA, consistent with applicable rules and regulations, although we note 
that the proposal does not specify a requirement for how HHAs may 
address patients' needs.
    Comment: Commenters that did not support the proposal acknowledged 
that SDOH information is important but adding four data elements to the 
OASIS and modifying a fifth would be burdensome. A commenter noted that 
revisions to the OASIS are too frequent and recommended that CMS limit 
revisions to intervals of no less than four years. A commenter 
suggested that the proposed living situation data element is 
duplicative of information that is already collected and recommended 
that the look-back for the utilities data element be changed from 12 
months to 3 months to capture more reliable, valid, and timely 
information. Another commenter encouraged CMS to consider using SDOH 
information as part of the risk-adjusted outcome quality measures. A 
commenter stated the proposal is not aligned with health-related social 
needs reporting requirements across the care continuum and that further 
testing and refinement are needed to ensure the proposed items work as 
intended in this setting. This commenter noted that CMS' evaluation of 
the AHC HRSN screening tool in the AHC Model showed that screening did 
not appear to increase beneficiary connection to community resources or 
health-related social need resolution, and they recommended CMS conduct 
further testing and developing clearer implementation guidance before 
adopting the proposed data elements in the HHQRP.
    Response: We acknowledge the commenters' concerns and appreciate 
their suggestions. As previously stated, we acknowledge that revisions 
to the OASIS require time and effort and resources for providers to 
prepare for the changes and we are committed to proposing revisions to 
the OASIS no more frequently than every 2 years. We disagree that the 
proposed Living Situation data element is duplicative of information 
that is already collected because it addresses housing insecurity, 
which is not part of the information captured in the current OASIS. We 
believe that the proposed data elements are not setting-specific, and 
that the testing conducted in their development has been sufficiently 
rigorous that we can adopt the data elements into the OASIS and the 
other PAC instruments with confidence.
    After consideration of the public comments we received, we are 
finalizing our proposal to adopt four new items as standardized patient 
assessment data elements in the SDOH category: one living situation 
item, two food items, and one utilities item, and to modify the 
transportation item in section III.D.5. of this rule beginning January 
1, 2027, with the CY 2027 HH QRP.
3. Effects of the Expanded HH VBP Model
    There were no proposed changes to the expanded HHVBP Model for CY 
2025. Therefore, we assumed there are no impacts resulting from this 
provision. Furthermore, the public comments received related to the 
Request for Information on Future Performance Measure Concepts for the 
Expanded HHVBP Model and the update on Future Approaches to Health 
Equity in the Expanded HHVBP Model, included in section IV. of the 
proposed rule, will be summarized in this final rule and may inform 
proposals through future rulemaking.

[[Page 88481]]

4. Impacts of Home IVIG Items and Services
    The following analysis applies to the home IVIG items and services 
payment rate as set forth in section V.D.1. of this final rule as added 
by section 4134 of the CAA, 2023 and accordingly, describes the impact 
for CY 2025 only. Table 36 represents the estimated aggregate costs of 
home IVIG users for CY 2025. We used CY 2023 data to identify 
beneficiaries actively enrolled in the IVIG demonstration (that is, 
beneficiaries with Part B claims that contain the Q2052 HCPCS code) to 
estimate the number of potential CY 2025 active enrollees in the new 
benefit, which are shown in column 2. In column 3, CY 2023 claims for 
IVIG visits under the Demonstration were again used to estimate 
potential utilization under the new benefit in CY 2025. Column 4 shows 
the final CY 2025 home IVIG items and services rate. The fifth column 
estimates the total cost to Medicare for CY 2025 ($9,535,238). The 
increase in estimated costs of covered IVIG items and services for CY 
2025 relative to the baseline year in CY 2024 (using updated CY 2023 
claims data as of July 26, 2024) is $250,000. Table 36 represents the 
estimated impacts of the home IVIG items and services payment for CY 
2025 by census region.
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5. HHA CoP Changes: Establishing an Acceptance-to-Service Policy
    We proposed to add a new standard Sec.  484.105(i), which sets 
forth a requirement for HHAs to establish an acceptance-to-service 
policy. All costs associated with this policy are located in the 
section VIII. of this final rule (Collection of Information). There are 
no transfers associated with this requirement.
6. Provider Enrollment Provisions
    For purposes of applying a PPEO, we proposed to expand the 
definition of ``new provider or supplier'' in Sec.  424.527(a) to 
include providers and suppliers that are reactivating their Medicare 
enrollment and billing privileges under Sec.  424.540(b). We stated in 
the proposed rule's regulatory impact section that we were unable to 
establish an estimate of any potential burden associated with this 
provision for two main reasons. First, we do not have sufficient data 
upon which we could formulate a burden projection. Second, we could not 
predict the scope, extent, and length of any future PPEO or the 
provider or supplier type(s) to which it may apply. Accordingly, we 
solicited public comment from stakeholders on the potential burden of 
our expansion of Sec.  424.527(a).
    We did not received comments regarding the potential impact of

[[Page 88482]]

Sec.  424.527(a)'s expansion and are therefore finalizing our 
assessments as discussed in the previous paragraph.
7. Effects of the LTC Requirements for Acute Respiratory Illness 
Reporting
    We proposed to update the requirements related to reporting acute 
respiratory illnesses for LTC facilities at Sec.  483.80(g). All cost 
associated with this policy are located in the section IX. of this 
final rule (Collection of Information). There are no transfers 
associated with this requirement. We welcomed public comments on our 
estimates, and on ways that reporting burden can be minimized while 
still providing adequate data. We also welcomed feedback on any 
challenges of collecting and reporting these data; ways that CMS could 
reduce reporting burden for facilities; and alternative reporting 
mechanisms or quality reporting programs through which CMS could 
instead effectively and sustainably incentivize reporting. Lastly, we 
welcomed comments that address system readiness and capacity to collect 
and report these data.
    A summary of comments received on the proposed rule can be found in 
sections VI.B. (Long-Term Care (LTC) Requirements for Acute Respiratory 
Illness Reporting) and section VIII.B.5. (Collection of Information) of 
this final rule.

D. Regulatory Review Cost Estimation

    If regulations impose administrative costs on private entities, 
such as the time needed to read and interpret this final rule, we 
should estimate the cost associated with the regulatory review. Due to 
the uncertainty involved with accurately quantifying the number of 
entities that will review the rule, we assume that the total number of 
unique commenters on this year's proposed rule will be the number of 
reviewers of this final rule. We acknowledge that this assumption may 
understate or overstate the costs of reviewing this rule. It is 
possible that not all commenters reviewed this year's proposed rule in 
detail, and it is also possible that some reviewers chose not to 
comment on the proposed rule. For these reasons we thought that the 
number of commenters would be a fair estimate of the number of 
reviewers of this rule. We also recognize that different types of 
entities are in many cases affected by mutually exclusive sections of 
this rule, and therefore for the purposes of our estimate we assume 
that each reviewer reads approximately 50 percent of the rule. Using 
the wage information from the BLS for medical and health service 
managers (Code 11-9111), we estimate that the cost of reviewing this 
rule is $106.42 per hour, including overhead and fringe benefits 
https://www.bls.gov/oes/current/oes_nat.htm. Assuming an average 
reading speed, we estimate that it would take approximately 3.49 hours 
for the staff to review half of this final rule. For each entity that 
reviews the rule, the estimated cost is $371.41 (3.49 hours x $106.42). 
Therefore, we estimate that the total cost of reviewing this regulation 
is $399,637 ($371.41 x 1,076) [1,076 is the number of estimated 
reviewers, which is based on the total number of unique commenters from 
this year's proposed rule].

E. Alternatives Considered

1. HH PPS
    For the CY 2025 HH PPS, we considered alternatives to the final 
provisions articulated in section II.C. of this rule. As described in 
section II.C.1.b. of this rule, we finalized a mapping of three OASIS 
items (therapies, vision, and pain) and a lookback period of 12 months 
in order to impute the responses from the OASIS-E to the OASIS-D to 
create simulated 60-day episodes from 30-day periods. We considered not 
mapping the three items (therapies, vision, and pain). Alternatives to 
the lookback period consisted of our initial proposal of 24 months and 
a shorter, three-month lookback period. We also considered no lookback 
period. However, to continue with the previously finalized methodology 
for assessing behavior changes, which uses certain OASIS items, we 
finalized the OASIS-E to OASIS-D mapping of the three items and a 12-
month lookback period.
    As described in section II.C.1.g. of this rule, to achieve 
appropriate payments, we calculated a permanent adjustment by 
determining what the 30-day base payment amount should have been in CYs 
2020, 2021, 2022, and 2023 in order to achieve the same estimated 
aggregate expenditures as obtained from the simulated 60-day episodes. 
One alternative to the -1.975 percent permanent adjustment, as 
finalized in this rule, included taking the full adjustment of -3.95 
percent. Another alternative would be to take the remaining permanent 
adjustment not taken in the CY 2024 HH PPS final rule, which resulted 
in -2.890 percent. Another alternative would be a phase-in approach, 
where we could reduce the permanent adjustment by spreading out the CY 
2025 permanent adjustment over a specified period of years, rather than 
halving the adjustment in CY 2025. Another alternative would be to 
delay the permanent adjustment to a future year. However, we are not 
taking the -3.95 adjustment as we wish to be responsive to commenter 
concerns about the on-going permanent adjustments to payment rate. 
Additionally, we believe that applying the permanent behavior 
adjustment calculated using CY 2023 claims over a period of several 
years, or delaying the permanent adjustment, would not be appropriate 
as it would further impact budget neutrality and likely lead to a 
compounding effect creating the need for a larger permanent reduction 
to the payment rate in future years. Therefore, we are finalizing a -
1.975 percent (half of the permanent -3.95 percent adjustment) 
permanent adjustment to the CY 2025 30-day payment rate. As stated 
previously in this final rule, we did not propose implementing the 
temporary adjustment to reconcile retrospective overpayments in CYs 
2020, 2021, 2022, and 2023.
    Finally, we considered not finalizing adopting the revised OMB 
delineations listed in OMB Bulletin 23-01. However, we have 
historically adopted the latest OMB delineations in subsequent 
rulemaking after a new OMB Bulletin is released. We continue to believe 
it is important for the HH PPS wage index to use the latest OMB 
delineations available in order to maintain a more accurate and up-to-
date payment system that reflects the reality of population shifts and 
labor market conditions.
2. Home IVIG Items and Services
    For the CY 2025 HH PPS, we did not consider alternatives to 
updating the home IVIG items and services payment for CY 2025 because 
section 1842(o)(8) of the Act requires the Secretary to establish a 
separate bundled payment to the supplier for all items and services 
related to the administration of intravenous immune globulin to an 
individual in the patient's home during a calendar day effective 
January 1, 2024, and to annually update this rate.

F. Accounting Statements and Tables

1. HH PPS
    As required by OMB Circular A-4 (available at https://www.whitehouse.gov/wp-content/uploads/legacy_drupal_files/omb/circulars/A4/a-4.pdf), in table 38, we have prepared an accounting 
statement showing the classification of the transfers and benefits 
associated with the CY 2025 HH PPS provisions of this final rule.

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2. HH QRP
    As required by OMB Circular A-4 (available at https://www.whitehouse.gov/wp-content/uploads/legacy_drupal_files/omb/circulars/A4/a-4.pdf), in table 39, we have prepared an accounting 
statement showing the classification of the costs associated with the 
ICRs for the proposed HH QRP provisions in CY 2027.
---------------------------------------------------------------------------

    \141\ https://www.sba.gov/sites/sbagov/files/2023-03/Table%20of%20Size%20Standards_Effective%20March%2017%2C%202023.xlsx.
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    We received no comments on the proposal and therefore are 
finalizing this provision without modification.
3. Home IVIG Items and Services
    As required by OMB Circular A-4 (available at https://www.whitehouse.gov/wp-content/uploads/legacy_drupal_files/omb/circulars/A4/a-4.pdf), in table 40, we have prepared an accounting 
statement showing the classification of the transfers and benefits 
associated with the CY 2025 IVIG provisions of this final rule.
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G. Regulatory Flexibility Act (RFA)

    The RFA requires agencies to analyze options for regulatory relief 
of small entities, if a rule has a significant impact on a substantial 
number of small entities. For purposes of the RFA, small entities 
include small businesses, nonprofit organizations, and small 
governmental jurisdictions. In addition, HHAs are small entities, as 
that is the term used in the RFA. Individuals and States are not 
included in the definition of a small entity.
    The North American Industry Classification System (NAICS) was 
adopted in 1997 and is the current standard used by the Federal 
statistical agencies related to the U.S. business economy. We utilized 
the NAICS U.S. industry title ``Home Health Care Services'' and 
corresponding NAICS code 621610 in determining impacts for small 
entities. The NAICS code 621610 has a size standard of $19 million 
\141\ and approximately 96 percent of HHAs are considered small 
entities. Table 41 shows the number of firms, revenue, and estimated 
impact per home health care service category.

[[Page 88484]]

[GRAPHIC] [TIFF OMITTED] TR07NO24.072

    The economic impact assessment is based on estimated Medicare 
payments (revenues) and HHS's practice in interpreting the RFA is to 
consider effects economically ``significant'' on a ``substantial'' 
number of small entities only if greater than 5 percent of providers 
reach a threshold of 3 to 5 percent or more of total revenue or total 
costs. The majority of HHAs' visits are Medicare paid visits and 
therefore the majority of HHAs' revenue consists of Medicare payments. 
We detail the CY 2025 HHA impacts by facility type and area of the 
country in table 35. Specifically, we estimate that the net impact of 
the policies in this final rule will only have a significant impact on 
HHAs in the East South Central Region, which is reflected in the last 
column in table 35 as a 3.2 percent increase in revenue when comparing 
CY 2025 payments to estimated CY 2024 payments. The East South Central 
represents 3.7 percent (357 of 9638) of the number of HHAs. HHAs in all 
other regions will experience net impacts ranging from -1.5 percent 
(Pacific Region) to 1.9 percent (West South Central). Furthermore, in 
section IX.E. of this final rule (Alternatives Considered), we provide 
a detailed analysis of the alternatives considered for the various 
provisions in this final rule. As a result, based on our analysis, we 
conclude that the provisions in this final rule will not result in an 
estimated total impact of 3 to 5 percent or more on Medicare revenue 
for greater than 5 percent of HHAs. Therefore, the Secretary certifies 
that this final rule will not have significant economic impact on a 
substantial number of small entities. We received no comments on the 
overall RFA analysis.
    This RFA section along with the RIA constitutes our final 
regulatory flexibility analysis.
    In addition, section 1102(b) of the Act requires us to prepare an 
RIA if a rule may have a significant impact on the operations of a 
substantial number of small rural hospitals. This analysis must conform 
to the provisions of section 604 of RFA. For purposes of section 
1102(b) of the Act, we define a small rural hospital as a hospital that 
is located outside of a metropolitan statistical area and has fewer 
than 100 beds. This final rule is not applicable to hospitals. 
Therefore, the Secretary has certified that this final rule would not 
have a significant economic impact on the operations of small rural 
hospitals.

H. Unfunded Mandates Reform Act (UMRA)

    Section 202 of UMRA of 1995 UMRA also requires that agencies assess 
anticipated costs and benefits before issuing any rule whose mandates 
require spending in any 1 year of $100 million in 1995 dollars, updated 
annually for inflation. In 2024, that threshold is approximately $183 
million. This rule will not impose a mandate that will result in the 
expenditure by State, local, and Tribal governments, in the aggregate, 
or by the private sector, of more than $183 million in any one year.

I. Federalism

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

J. Conclusion

    In conclusion, we estimated that the provisions in this rule will 
result in an estimated net increase in home health payments of 0.5 
percent for CY 2025 ($85 million). The $85 million increase in 
estimated payments for CY 2025 reflects the effects of the final CY 
2025 home health payment update percentage increase of 2.7 percent 
($460 million increase), a 0.4 percent decrease in payments due to the 
new higher FDL ratio, which will decrease outlier payments in order to 
target to pay no more than 2.5 percent of total payments as outlier 
payments ($70 million decrease), and an estimated 1.8 percent decrease 
in payments that reflects the effects of the permanent behavior 
adjustment ($305 million decrease). In addition, the estimated impact 
of the

[[Page 88485]]

home IVIG items and services payment for CY 2025 is an increase of 
$250,000.

K. Waiver Fiscal Responsibility Act Requirements

    The Director of OMB has waived the requirements of section 263 of 
the Fiscal Responsibility Act of 2023 (Pub. L. 118-5) pursuant to 
sections 265(a)(1) and (a)(2) of Public Law 118-5.
    Chiquita Brooks-LaSure, Administrator of the Centers for Medicare & 
Medicaid Services, approved this document on October 17, 2024.

List of Subjects

42 CFR Part 424

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

42 CFR Part 483

    Grant programs--health, Health facilities, Health professions, 
Health records, Medicaid, Medicare, Nursing homes, Nutrition, Reporting 
and recordkeeping requirements, Safety.

42 CFR Part 484

    Health facilities, Health professions, Medicare, Reporting and 
recordkeeping requirements.

    For the reasons set forth in the preamble, the Centers for Medicare 
& Medicaid Services amends 42 CFR chapter IV as follows:

PART 424-CONDITIONS FOR MEDICARE PAYMENT

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

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


0
2. Section 424.527 is amended by adding paragraph (a)(4) to read as 
follows:


Sec.  424.527  Provisional period of enhanced oversight.

    (a) * * *
    (4) A provider or supplier reactivating the provider's or 
supplier's Medicare enrollment and billing privileges in accordance 
with Sec.  424.540(b).
* * * * *

PART 483--REQUIREMENTS FOR STATES AND LONG TERM CARE FACILITIES

0
3. The authority citation for part 483 continues to read as follows:

    Authority:  42 U.S.C. 1302, 1320a-7, 1395i, 1395hh and 1396r.


0
4. Section 483.80 is amended by revising paragraph (g) to read as 
follows:


Sec.  483.80  Infection control.

* * * * *
    (g) Respiratory illness reporting--(1) Ongoing reporting. The 
facility must electronically report information on acute respiratory 
illnesses, including influenza, severe acute respiratory syndrome 
coronavirus 2 (SARS-CoV-2)/coronavirus 2019 (COVID-19), and respiratory 
syncytial virus (RSV).
    (i) The report must be in a standardized format and frequency 
specified by the Secretary.
    (ii) To the extent as required by the Secretary, this report must 
include all of the following data elements:
    (A) Facility census (defined as the total number of residents 
occupying a bed at this facility for at least 24 hours during the week 
of data collection).
    (B) Resident vaccination status for a limited set of respiratory 
illnesses, including but not limited to the following:
    (1) Influenza.
    (2) SARS-CoV-2/COVID-19.
    (3) RSV.
    (C) Confirmed, resident cases of a limited set of respiratory 
illnesses, including but not limited to the following:
    (1) Influenza.
    (2) SARS-CoV-2/COVID-19.
    (3) RSV.
    (D) Hospitalized residents with confirmed cases of a limited set of 
respiratory illnesses, including but not limited to the following:
    (1) Influenza.
    (2) SARS-CoV-2/COVID-19.
    (3) RSV.
    (2) Public health emergency (PHE) reporting. In the event that the 
Secretary has declared a national, State, or local PHE for an acute 
infectious illness, the facility must also electronically report all of 
the following data elements in a standardized format and frequency 
specified by the Secretary:
    (i) Relevant confirmed infections for staff.
    (ii) Supply inventory shortages.
    (iii) Staffing shortages.
    (iv) Relevant medical countermeasures and therapeutic inventories, 
usage, or both.

PART 484--HOME HEALTH SERVICES

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

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


0
6. Section 484.105 is amended by adding paragraph (i) to read as 
follows:


Sec.  484.105  Condition of participation: Organization and 
administration of services.

* * * * *
    (i) HHA acceptance-to-service. An HHA must do both of the 
following:
    (1) Develop, implement, and maintain through an annual review, a 
patient acceptance-to-service policy that is applied consistently to 
each prospective patient referred for home health care, which addresses 
criteria related to the HHA's capacity to provide patient care, 
including, but not limited to, all of the following:
    (i) Anticipated needs of the referred prospective patient.
    (ii) Case load and case mix of the HHA.
    (iii) Staffing levels of the HHA.
    (iv) Skills and competencies of the HHA staff.
    (2)(i) Make available to the public accurate information regarding 
the services offered by the HHA and any limitations related to types of 
specialty services, service duration, or service frequency.
    (ii) Review the information specified in paragraph (i)(2)(i) of 
this section as frequently as the services are changed, but no less 
often than annually.

Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2024-25441 Filed 11-1-24; 4:15 pm]
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